REGISTERED OFFICE AND
CORPORATE HEADQUARTERS
AstraZeneca PLC
15 Stanhope Gate
London W1K 1LN
UK
Tel: +44 (0)20 7304 5000
Fax: +44 (0)20 7304 5151
INVESTOR RELATIONS
E-mail:
IR@astrazeneca.com
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Sweden:
AstraZeneca AB
SE-151 85 Söderlje
Sweden
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US:
Investor Relations
AstraZeneca Pharmaceuticals LP
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DE 19850-5437
US
Tel: +1 (302) 886 3000
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Tel (toll free in the US):
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ASTRAZENECA.COM
This Annual Report and Form 20-F Information
is also available online at astrazeneca.com/
annualreport2008
CONTACT INFORMATION
ASTRAZENECA ANNUAL REPORT AND FORM 20-F INFORMATION 2008
ASTRAZENECA ANNUAL REPORT
AND FORM 20-F INFORMATION 2008
Cautionary statement regarding forward-looking
statements
The purpose of this Annual Report and Form 20-F
Information is to provide information to the members
of the Company. In order, among other things, to
utilise the ‘safe harbour’ provisions of the US Private
Securities Litigation Reform Act 1995 and the UK
Companies Act 2006, we are providing the following
cautionary statement: This Annual Report and Form
20-F Information contains certain forward-looking
statements with respect to the operations,
performance and financial condition of the Group.
Although we believe our expectations are based on
reasonable assumptions, any forward-looking
statements, by their nature, involve risks and
uncertainties and may be influenced by factors
that could cause actual outcomes and results to
IMPORTANT INFORMATION
FOR READERS OF THIS REPORT
be materially different from those predicted. The
forward-looking statements reflect knowledge and
information available at the date of the preparation
of this Annual Report and Form 20-F Information
and the Company undertakes no obligation to
update these forward-looking statements. We
identify the forward-looking statements by using the
words ‘anticipates’, ‘believes’, ‘expects’, ‘intends’
and similar expressions in such statements.
Important factors that could cause actual results to
differ materially from those contained in forward-
looking statements, certain of which are beyond our
control, include, among other things, those factors
identified in the Principal Risks and Uncertainties
section on pages 74 to 82 of this document.
Nothing in this Annual Report and Form 20-F
Information should be construed as a profit
forecast.
Inclusion of reported, constant exchange rate
and core financial measures
Throughout the Directors’ Report and in the Financial
Highlights section on page 2 and 3 the following
measures are referred to:
Reported performance. Reported performance >
takes into account all the factors (including those
which we cannot influence, principally currency
exchange rates) that have affected the results of our
business as reflected in our Group Financial
Statements prepared in accordance with
International Financial Reporting Standards as
adopted by the European Union and as issued by
the International Accounting Standards Board.
Core financial measures. This is a non-GAAP measure >
because unlike reported performance it cannot be
derived directly from the information in the Group’s
Financial Statements. This measure is adjusted to
exclude certain significant items, such as charges
INTRODUCTION 2
AstraZeneca and our year in brief 2
Financial highlights 2
Chairman’s statement 4
Chief Executive Officer’s review 5
DIRECTORS’ REPORT 8
Introduction 8
Business environment 9
Strategy, goals and
performance measurement 12
Measuring our performance 1 > 4
Reporting our performance >
Financial and Non-financial 15
Resources, skills and capabilities 16
Medicines 1 > 6
Research and development 1 > 7
Development pipeline >
at 29 January 2009 22
Sales and marketing 2 > 5
Intellectual property 2 > 6
Supply and manufacturing 2 > 7
People 2 > 8
Financial review 31
Measuring performance 3 > 1
Business background and >
major events affecting 2008 32
Results of operations >
summary analysis of year
to 31 December 2008 33
Financial position, including >
cash flow and liquidity – 2008 34
Restructuring and synergy costs > 36
Capitalisation and shareholder return > 37
Future prospects 3 > 7
Results of operations >
summary analysis of year to
31 December 2007 38
Financial position, including >
cash flow and liquidity – 2007 40
Financial risk management 4 > 1
Critical accounting policies >
and estimates 43
Other accounting information 4 > 7
DIRECTORS’ REPORT 8
FINANCIAL STATEMENTS 98
REMUNERATION REPORT 174
ADDITIONAL INFORMATION 190
TRADE MARkS
Trade marks of the AstraZeneca group of companies
appear throughout this document in italics. AstraZeneca,
the AstraZeneca logotype and the AstraZeneca
symbol are all trade marks of the AstraZeneca group
of companies. Trade marks of companies other than
AstraZeneca appear with a
®
or
sign and include:
Abraxane
®
, a registered trade mark of Abraxis
BioScience, LLC.; Advair Diskus
, a trade mark
of GlaxoSmithKline group of companies; Aspirin
,
a trade mark of Bayer AG; Avastin
, a trade mark of
Genentech, Inc.; BiTE
, a trade mark of Micromet AG;
Cubicin
, a trade mark of Cubist Pharmaceuticals, Inc.;
Captisol
, a trade mark of CyDex Pharmaceuticals Inc.;
CytoFab
, a trade mark of Protherics, Inc.; Enbrel
,
a trade mark of Amgen group of companies;
EvaluatePharma
®
, a trade mark of Evaluate PLC;
Herceptin
, a trade mark of Genentech, Inc.; Humira
,
a trade mark of Abbott Biotechnology Ltd; Lean Sigma
,
a trade mark of Smallpiece Enterprises Limited;
Lipitor
, a trade mark of Pfizer Ireland Pharmaceuticals;
Onglyza
, a trade mark of the Bristol-Myers Squibb
Company; Prinivil
, a trade mark of Merck & Co., Inc.;
Remicade
, a trade mark of Centocor, Inc.; Seretide
,
a trade mark of GlaxoSmithKline group of companies;
Taxotere
, a trade mark of Aventis Pharma SA; TriCor
,
a trade mark of Fournier Industrie et Santé; Trilipix
,
a trade mark of Abbott Laboratories; Zocor
, a trade
mark of Merck & Co., Inc.; and Zyprexa
, a trade mark
of Eli Lilly and Company.
USE OF TERMS
In this Annual Report and Form 20-F Information,
unless the context otherwise requires, ‘AstraZeneca’,
‘the Group’, ‘we’, ‘us’ and ‘our’ refer to AstraZeneca
PLC and its consolidated entities.
STATEMENTS OF DATES
Except as otherwise stated, references to days
and/or months in this Annual Report and Form 20-F
Information are references to days and/or months
in 2008.
Designed by Addison Corporate Marketing Limited.
1
INTRODUCTION DIReCTORs’ RepORT ReMUNeRATION RepORTFINANCIAL sTATeMeNTs ADDITIONAL INFORMATION
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
and provisions related to restructuring and synergy
programmes, amortisation and the impairment of
the significant intangibles arising from corporate
acquisitions and those related to our current and
future exit arrangements with Merck in the US,
and other specified items. A reconciliation between
reported performance and core performance is
provided on page 34.
Constant exchange rate (CER) growth rates. This is >
also a non-GAAP measure. This measure removes
the effects of currency movements (by retranslating
the current year’s performance at previous years’
exchange rates and adjusting for other exchange
effects, including hedging). A reconciliation of reported
results adjusted for the impact of currency movements
is provided on page 33.
Throughout this Annual Report and Form 20-F
Information, growth rates are expressed at CER
unless otherwise stated.
Statements of competitive position,
growth rates and sales
In this Annual Report and Form 20-F Information, except
as otherwise stated, market information regarding the
position of our business or products relative to its or
their competition is based upon published statistical
sales data for the 12 months ended 30 September 2008
obtained from IMS Health, a leading supplier of statistical
data to the pharmaceutical industry. For the US,
dispensed new or total prescription data are taken from
the IMS Health National Prescription Audit for the 12
months ended 31 December 2008. Except as otherwise
stated, these market share and industry data from IMS
Health have been derived by comparing our sales
revenue to competitors’ and total market sales revenues
for that period. Except as otherwise stated, growth rates
and sales are given at constant exchange rates. For the
purposes of this Annual Report and Form 20-F
Information, unless otherwise stated references to the
world pharmaceutical market or similar phrases are to
52 countries contained in IMS Health MIDAS Quantum
database, which amounted to approximately 95% (in
value) of the countries audited by IMS.
AstraZeneca websites
Information on or accessible through our websites,
including astrazeneca.com, astrazenecaclinicaltrials.com,
medimmune.com and cambridgeantibody.com, does
not form part of this document.
External/third party websites
Information on or accessible through any third party or
external website does not form part of this document.
Geographical review 48
North America 48 >
Rest of World 50 >
Therapy area review 53
Cardiovascular 5 > 4
Gastrointestinal 5 > 7
Infection 5 > 9
Neuroscience 6 > 1
Oncology 6 > 4
Respiratory and Inflammation 6 > 7
Other businesses 70
Environmental sustainability 71
In the global community 72
Risk 74
Managing risk, principal risks >
and uncertainties 74
Principal risks and uncertainties 7 > 6
Business organisation and
Corporate governance 83
Business organisation 8 > 3
Board of Directors at >
31 December 2008 84
Chief Executive Officer, >
delegation of authority
and Senior Executive Team 86
FINANCIAl STATEmENTS 98
Preparation of the
Financial Statements and
Directors’ responsibilities 98
Directors’ responsibility >
statement pursuant to DTR 4 98
Directors’ responsibilities for,
and report on, internal control
over financial reporting 98
Auditors reports on the
Financial Statements and on internal
control over financial reporting
(Sarbanes‑Oxley Act section 404) 99
Independent auditor’s
report to the members of
AstraZeneca PLC (Group) 99
Consolidated income statement
for the year ended 31 December 100
Consolidated statement of
recognised income and expense
for the year ended 31 December 100
Consolidated balance sheet
at 31 December 101
Consolidated cash flow statement
for the year ended 31 December 102
Accounting policies 103
Basis of accounting and preparation >
of financial information 103
Notes to the Financial Statements
(Group) 108
1 Operating profit 108
2 Finance income and expense 108
3 Taxation 109
4 Earnings per $0.25
Ordinary Share 111
5 Segment information 111
6 Product revenue information 113
7 Property, plant and equipment 114
8 Goodwill 115
9 Intangible assets 116
10 Other investments 118
11 Inventories 118
12 Trade and other receivables 119
13 Cash and cash equivalents 119
14 Interest bearing loans
and borrowings 119
15 Financial risk management
objectives and policies 120
16 Financial instruments 122
17 Trade and other payables 127
18 Provisions for liabilities
and charges 127
19 Capital and reserves 128
20 Share capital of parent company 129
21 Dividends to shareholders 129
22 Acquisitions of
business operations 130
23 Post-retirement benefits 133
24 Employee costs and share
option plans for employees 138
25 Commitments and
contingent liabilities 144
26 Leases 163
27 Statutory and other information 163
Principal subsidiaries 164
Independent auditor’s report to
the members of AstraZeneca PLC 165
Company balance sheet 166
Accounting policies (Company) 167
Notes to the Financial Statements
(Company) 168
1 Fixed asset investments 168
2 Non-trade creditors 168
3 Loans 168
4 Reserves 169
5 Reconciliation of movement
in shareholders’ funds 169
6 Share capital 170
7 Litigation and
environmental liabilities 170
8 Statutory and other information 171
Group financial record 172
dIRECToRS’ REmuNERATIoN REpoRT 174
AddITIoNAl INFoRmATIoN 190
Shareholder information 190
Corporate information 197
Cross‑reference to Form 20‑F 198
Glossary 199
2
08
07
06
31,601
29,559
26,475
SALES $M
+3%
+7%
+11%
GROWTH
Core 08
Reported 08
Reported 07
10,958
9,144
8,094
Reported 06 8,216
OPERATING PROFIT $M
+9%
+4%
-4%
+28%
GROWTH
08
07
06
5,200
5,216
5,182
NEXIUM -2%
08
07
06
4,452
4,027
3,416
SEROQUEL +9%
08
07
06
807
1,438
1,795
SELOKEN/TOPROL-XL -46%
08
07
06
1,055
1,143
1,371
LOSEC/PRILOSEC -14%
08
07
06
3,597
2,796
2,028
CRESTOR +26%
08
07
06
5.10
4.38
3.92
CORE EARNINGS
PER ORDINARY SHARE $
+8%
+10%
+33%
GROWTH
08
07
06
2,739 610
2,641 4,170
2,220 4,147
DISTRIBUTIONS TO SHAREHOLDERS:
DIVIDENDS AND SHARE RE-PURCHASES $M
DIVIDENDS SHARE RE-PURCHASES
08
07
06
1,495
1,454
1,292
PULMICORT +0%
08
07
06
1,258
1,335
1,206
CASODEX -12%
08
07
06
1,471
1,287
1,110
ATACAND +10%
08
07
06
897
773
604
MERREM +13%
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
AsTRAZeNeCA Is ONe OF THe WORLD’s
LeADING pHARMACeUTICAL COMpANIes WITH
A BROAD RANGe OF MeDICINes DesIGNeD
TO FIGHT DIseAse IN IMpORTANT AReAs OF
HeALTHCARe. BACkeD By sTRONG sCIeNCe
AND WIDe‑RANGING COMMeRCIAL skILLs,
We ARe COMMITTeD TO THe sUsTAINABLe
DeveLOpMeNT OF OUR BUsINess AND THe
DeLIveRy OF A FLOW OF NeW MeDICINes
THAT BRING BeNeFIT FOR pATIeNTs
AND CReATe eNDURING vALUe FOR OUR
sHAReHOLDeRs AND sOCIeTy.
AsTRAZeNeCA AND OUR yeAR IN BRIeF
FINANCIAL HIGHLIGHTs
pRoduCT pERFoRmANCE SummARy $m
dIVIdENd FoR 2008
$ Pence SEK Payment date
First interim dividend 0.55 27.8 3.34 15 September 2008
Second interim dividend 1.50 104.8 12.02 16 March 2009
Total 2.05 132.6 15.36
3
INTRODUCTION
08
07
06
8,742
7,510
7,693
NET CASH FLOW
FROM OPERATING ACTIVITIES $M
08
07
06
4.20
3.74
3.86
REPORTED BASIC EARNINGS
PER ORDINARY SHARE $
+2%
-5%
+34%
GROWTH
08
07
06
1,857
1,730
1,508
ARIMIDEX +4%
08
07
06
1,138
1,104
1,008
ZOLADEX -3%
08
07
1,230
618
SYNAGIS
1
n/m
08
07
104
53
FLUMIST
1
n/m
08
07
06
2,004
1,575
1,184
SYMBICORT +22%
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
2008 IN bRIEF
Sales up 3% to $31,601 million. >
Crestor > sales up 26% to $3,597 million; Symbicort
up 22% to $2,004 million; Seroquel up 9% to
$4,452 million; and Arimidex up 4% to $1,857
million. Nexium sales down 2% to $5,200 million.
Our product portfolio now includes 11 medicines >
with annual sales of more than $1 billion each.
Sales in Emerging Markets reached $4,273 million >
for the full year, up 16%.
Investment in R&D in line with 2007 at $5.2 billion. >
Core operating profit up 9% to $10,958 million. >
Core operating margin improved to 34.7% >
of sales on operational efficiencies in all
functional areas.
Core EPS for the full year increased by 8% to $5.10. >
Reported EPS for the full year increased by 2%, >
reflecting higher intangible asset impairments
and a full year of MedImmune amortisation
compared with 2007.
Dividend up 10% to $2.05 for the full year. >
Cash distributions to shareholders totalled >
$3,349 million (dividends $2,739 million;
share re‑purchases $610 million).
Net debt reduced by $1.9 billion on strong cash >
performance and investment discipline.
Eight significant regulatory lifecycle >
management submissions; two product
submissions. Phase III pipeline volume remains
constant. Phase II pipeline increased by over
50%. Nominated 32 FGLPs and exceeded our
target for progressing these into man.
New initiatives extend the scope of restructuring >
programme to sustain long‑term competitiveness.
35 significant business development transactions >
including extensions of existing agreements.
Summary Judgment Motion granted to >
AstraZeneca in the patent infringement actions
commenced against two generic drug
manufacturers in the US following abbreviated
new drug applications relating to Seroquel.
Settlement of US > Nexium patent litigation with
enforceability of disputed Nexium patents
conceded. Other patent litigation continuing
in the US against generic manufacturers
following abbreviated new drug applications
relating to Nexium.
New Code of Conduct launched in over >
40 languages and all employees trained.
Growth rates expressed above are CER growth rates.
1
Acquired in June 2007.
4
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
During 2008, AstraZeneca maintained its
strong focus on delivering benefit to patients
and value to shareholders and society through
industry-leading R&D productivity, commercial
excellence and operational efficiency.
Group sales increased by 3% in 2008 to
a total of $31.6 billion. Operating profit was
$9.1 billion, up 4%. Reported earnings per
share for the full year were $4.20 ($3.74 in
2007). The Board has recommended an 11%
increase in the second interim dividend to
$1.50 (104.8 pence, SEK 12.02) per Ordinary
Share. This brings the dividend for the full year
to $2.05 (132.6 pence, SEK 15.36), an increase
of 10%. In 2008, cash distributions to
shareholders, through a combination of
dividends and share re-purchases totalled
$3,349 million. Share re-purchases for the full
year amounted to $610 million. Shareholders
also benefited in 2008 from an improvement
in the Company share price. The London-
listed share price increased by 30% during
the course of 2008, as compared to a
decline of 31% for the FTSE 100 index.
During the year, we continued to invest in
enhancing our R&D capabilities alongside
accessing high quality opportunities externally.
This investment is guided by our disease
area strategy, which reflects both our inherent
strengths and the areas of greatest unmet
medical need. We now have a strong
development portfolio of small molecule and
biological products targeted at bringing new
therapeutic approaches to important areas of
healthcare as quickly and safely as possible.
In particular, the improvements we have made
to our cycle times mean that we should
deliver new medicines to patients even faster.
We continued to drive sales growth despite
continuing pricing and intellectual property
challenges in our Established Markets.
Managing the impact of challenges from
generic manufacturers is now a key feature
of our business. The Board was pleased to
support the Senior Executive Team strategy
of settling legal challenges concerning
Nexium and Pulmicort Respules, rather than
managing the continued cost and uncertainty
associated with a sustained legal defence.
Protecting our intellectual property ensures
that we can re-invest in the discovery and
development of the medicines of the future
and we must manage this important asset
actively and effectively over the long term.
We continued our investment in fast-growing
economies to strengthen our platform
for growth in key Emerging Markets, and,
alongside the rest of the pharmaceutical
industry, we continued to drive efficiencies
across our organisation to support sustained
shareholder returns.
In conjunction with the Senior Executive
Team, during 2008 the Board reviewed
the Group’s strategy. This review reinforced
our commitment to delivering differentiated
medicines that make a meaningful difference
to patients’ lives and to doing so in an efficient,
focused, cost-effective and responsible
manner. More information about the work and
operation of the Board and its Committees
is set out in the Business Organisation and
Corporate Governance section of this Report.
In February and September 2008 we
announced the appointments of Jean-Philippe
Courtois and Rudy Markham respectively.
Jean-Philippe’s considerable experience
with Microsoft in global sales and marketing,
including Emerging Markets, will be of great
benefit to the work of the Board. Rudy’s
considerable experience of over 35 years
at Unilever, latterly in finance, will also be
invaluable to the work of the Board and to
the Audit Committee.
In November 2008, we announced the
retirement of John Patterson who will leave
the Company after 34 years of service and
will retire from the Board on 31 March 2009.
John has made an important and highly valued
contribution to the business over the course
of his career with AstraZeneca and over the
last five years as a member of the Board.
At the end of 2008, Graeme Musker stepped
down from his position as Group Secretary
and Solicitor, and will retire in early 2009.
The Board appointed Adrian Kemp to the
position of Company Secretary with effect
from 1 January 2009. On behalf of the Board,
I would like to thank Graeme for his 30 years’
of invaluable service, advice and guidance to
the Board and the Company.
The Board continues to be confident in the
strong leadership of David Brennan and his
Senior Executive Team and would like to
thank them and all AstraZeneca’s employees
for their hard work and dedication, which
underpins the Company’s success.
The fundamentals of the world pharmaceutical
market remain robust. Although industry
growth is slowing, mainly due to ever-greater
pressure on costs and increased generic
competition, the continued demand for
healthcare that underpins the industry’s
future growth prospects remains strong.
The pharmaceutical industry is also arguably
less exposed than other sectors to the current
global economic downturn, although some
impact may result from increased constraints
on payers, suppliers and distributors.
Nevertheless, our rapidly changing business
environment will continue to be a challenging
one. The companies that will be most
successful will be those that are able to manage
the risks and maximise the opportunities
effectively, through timely and efficient
investment, appropriate use of intellectual
property and constructive stakeholder
engagement. I am confident that AstraZeneca
is such a company and that, with our clear
strategy, strong leadership and intense focus
on execution, we will continue to deliver
sustainable success, to the benefit of
patients, shareholders and society.
louIS SCHWEITZER
Chairman
CHAIRMAN’s sTATeMeNT
5
INTRODUCTION
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
CHIeF eXeCUTIve OFFICeRs RevIeW
We are committed to delivering on our
strategy and to changing the way we work
so we are prepared for the future. 2008 was
a year of both opportunity and challenge for
the Company. I am proud to report that we
delivered some significant successes against
a tough background of slowing growth rates
in Established Markets, ever-greater pressure
on costs and increasing challenge from
generic manufacturers.
Our strategy is clear. At its simplest, it is to
create enduring value for shareholders by
delivering medicines that make a meaningful
difference to patient health.
Our vision is to be an innovation-driven,
research-based pharmaceutical company
focused on human health and capable of
delivering a consistent flow of innovative and
differentiated products to patients in markets
around the world. To achieve this we will make
sustained investment in an industry-leading,
externally networked R&D organisation with
expertise in both small molecule and large
molecule technologies. We will commercialise
our products rapidly and globally at affordable
prices through a world class sales and
marketing organisation operating in both
primary and specialty care markets.
Underpinning our research and commercial
operations will be a supply chain and
operating infrastructure, through which we are
aiming to achieve industry-leading efficiency.
Above all, we will seek to apply an investment
discipline to all of our activities that attaches
equal weight to delivering patient health and
creating shareholder wealth. We will only
invest shareholders’ funds where we see
attractive returns and the opportunity to
create enduring shareholder value.
To help the organisation maintain our focus
on execution, our strategy targets four
main priorities:
STRENGTHENING ouR pIpElINE
We are discovering and developing effective
medicines faster than ever before and the
considerable progress we have made in
reducing development cycle times and costs
has been achieved without compromising on
safety and quality.
During 2008, we made eight significant
regulatory submissions across several
jurisdictions to broaden the use of our
marketed products Seroquel, Symbicort,
Iressa and FluMist, as well as two new product
submissions for motavizumab, an improved
anti-respiratory syncytial virus monoclonal
antibody, and Onglyza
, for treating Type 2
diabetes. We have strengthened our mid-stage
pipeline and now have 10 projects in Phase
III development. 32 projects entered the
pipeline during the year and 44 projects were
progressed to their next phase of development.
We now have a total of 144 projects within
a balanced pipeline of small molecule and
biological products. This compares with 137
projects in 2007.
We also continue to pursue high quality
external opportunities to enhance further our
in-house capabilities and have completed
over 40 major deals in the last two years.
These deals have increased the quality and
size of our pipeline and improved the prospects
of consistently launching more new medicines
each year as the pipeline matures.
GRoWING THE buSINESS
Backed by our 70 year track record of
innovation, we have a range of medicines
on the market that continue to make a
difference in important areas of healthcare –
and our commitment to delivering the full
benefit of these medicines to patients and
maximising their commercial potential
remains undiminished.
Highlights of the year included the conclusion
of a major study of our statin, Crestor, in the
primary prevention area, which demonstrated
significant reduction in major cardiovascular
events – 44% compared to placebo in men
and women with elevated hsCRP and other
risk factors but low/normal cholesterol levels,
a level of cardiovascular risk reduction not
previously seen in a large placebo controlled
statin outcome trial.
Seroquel XR has had approvals for acute
bipolar depression, acute bipolar mania and
as an adjunct therapy to lithium or divalproex
for bipolar maintenance treatment in a number
of major jurisdictions. These approvals for
new indications put Seroquel XR on track
to deliver its full therapeutic potential.
In addition, our expertise in regulatory, sales
and marketing is also helping to bring to
markets outside the US the biological products
that MedImmune brought to our range,
specifically motavizumab and FluMist.
Despite the challenging market conditions,
we have continued to drive high performance
and market share gains in our Established
Markets and increased sales across North
America, Europe and Japan. I believe our sales
forces are among the best and we continue
to evolve our commercial model to ensure
that we stay at the forefront of best practice
in meeting the needs of our customers.
We continue to deliver strong, profitable growth
in our Emerging Markets, while continuing
our strategic investment in these markets
aimed at ensuring that we are appropriately
resourced to deliver the full potential of the
business opportunities in these developing
economies. One in seven dollars of our sales
now comes from Emerging Markets and as
our presence in these countries matures, and
as their economies strengthen, I am confident
that we will be able to increase further
business efficiency and deliver improved
profitability in the future.
We received further challenges to some of our
patents during the year, the details of which
are set out elsewhere in this Report. We will
continue to vigorously defend our patents
to protect the many years of research and
the considerable investment which have
delivered the medicines to which those
patents relate.
bEComING lEAN ANd AGIlE
We have to be relentless in our pursuit of
opportunities to drive further efficiencies
across the value chain. As well as the progress
delivered in R&D, we have reshaped our
manufacturing and packing activities to
improve productivity whilst maintaining high
standards of quality and security; we have
established agreements with third parties
who offer specialist outsourced expertise
in areas ranging from data management
to catering; and put even greater focus
on leveraging efficiencies within our global
procurement activity.
6
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
SENIoR EXECuTIVE TEAm (SET) CHANGES
I am delighted that we have further
strengthened the SET through the
appointments of Anders Ekblom and Jeff
Pott. Anders was appointed to the role of
Executive Vice-President, Development with
effect from 1 January 2009. Jeff has already
taken up his new role as the Group’s General
Counsel, having spent a number of years as
legal counsel within AstraZeneca’s US
business, most recently with responsibility
for managing intellectual property litigation
within the US.
During 2008 we announced that, after a long
and distinguished career within the Company,
John Patterson, Executive Director,
Development, will retire at the end of March
2009. John has made an important and
lasting contribution to the business over the
course of his career with AstraZeneca. Under
his leadership, the productivity and efficiency
of our product development has improved
significantly, and we now have the largest
pipeline in our history. Also in 2008, David
Mott, formerly President of MedImmune left
the Company to pursue other opportunities.
The role of President of MedImmune has
been taken on by Tony Zook, who has also
retained his responsibilities as Chief Executive
Officer, North America and Executive
Vice-President, Global Marketing.
looKING AHEAd
Despite the very significant and economic
challenges being experienced around the
world, I am confident the progress that we
continue to make in our four priority areas
means AstraZeneca is well placed to manage
the challenges and opportunities of a rapidly
changing business environment. I believe that
we have the strategy, the engines for growth
and the levels of commitment it takes to
continue making a meaningful difference in
patient health through great medicines, and
creating enduring value for our shareholders
and society.
dAVId R bRENNAN
Chief Executive Officer
Our continuing drive to improve efficiency
and effectiveness resulted in further planned
reductions of our workforce in some areas
of our business during 2008 and our work
on these initiatives continues. My
management teams and I, take these
changes very seriously and remain
committed to ensuring that we manage these
changes in line with our core values.
Throughout, we have consulted with staff
representatives and acted in line with local
labour laws. We have also provided
appropriate support to help individuals
pursue their careers beyond AstraZeneca
and have engaged with communities around
the affected sites to mitigate the local impact.
doING buSINESS THE RIGHT WAy
I want AstraZeneca to be valued as a source
of great medicines, but also to be trusted for
the way in which we do business. Therefore,
our strategic focus includes a fourth priority,
which underpins and supports achievement
of the first three. We must continue to nurture
a culture of responsibility and accountability
across all aspects of our business activity to
ensure that AstraZeneca continues to be
welcomed as a trusted member of society.
Our core values are the cornerstone of this
culture and in 2007, we reviewed and
expanded our Code of Conduct to provide
clear direction as to how these high level
values are to be translated into consistent
actions across all areas of our business.
The new Code went into effect in 2008, and
it was followed by mandatory training during
the year for everyone in the Company.
During the year, 86% of our employees
participated in our global employee opinion
survey. Results showed that employee
engagement scores – defined as the extent
to which people are committed to the future
success of the Company – were very strong,
and we continue to outperform other
pharmaceutical companies in this area.
The results also indicated that people were
seeing increased levels of co-operation
between senior leaders, leading to more
effective global and cross-functional working.
The survey also identified some key areas
that continue to require attention, including
change management, personal development
and leadership communication. I take this
feedback very seriously and new targets that
address these issues have been included in
the Senior Executive Team’s performance
goals for 2009.
DIRECTORS’ REPORT
8
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
ASTRAZENECA IN BRIEF
Focused on the discovery, development, >
manufacturing and marketing of prescription
pharmaceuticals and biological products for
important areas of healthcare: Cardiovascular,
Gastrointestinal, Infection, Neuroscience,
Oncology, and Respiratory and Inflammation.
Broad product range, including many world >
leaders and a number of key products: Arimidex,
Crestor, Nexium, Seroquel and Symbicort.
Active in over 100 countries with a growing >
presence in important emerging markets
including China; corporate office in London, UK;
major R&D sites in Sweden, the UK and the US.
Over 65,000 employees (51% in Europe, >
32% in the Americas and 17% in Asia, Africa
and Australasia).
Around 12,000 people in our R&D organisation >
and 17 principal R&D centres in eight countries.
26 manufacturing sites in 18 countries. >
Committed to a responsible approach >
to business across all activities.
In this Directors’ Report, we have applied the
best practice principles of an Operating and
Financial Review and, to demonstrate how
we have performed our duty to promote the
success of the Company, we discuss the main
trends and factors underlying the development,
performance and position of AstraZeneca
in 2008.
We summarise the opportunities and
challenges of our business environment,
including the world market for pharmaceuticals
and biological products; the competitive and
regulatory environment; and the principal
risks and uncertainties we face, as well as
the importance of intellectual property rights.
We describe our strategy for creating
enduring value for shareholders, patients
and other stakeholders and explain how
our progress towards achieving our strategic
goals is measured.
We provide an overview of the resources,
skills and capabilities that we have in place
and how they are aligned to the achievement
of our goals. This includes information
about the ways in which our medicines are
differentiated and effective, as well as details
of our research and development, sales and
marketing, and supply and manufacturing
activities worldwide. We also describe our
commitment to ensuring that our global
workforce continues to be motivated and
clear about what is required of them as we
drive the continued success of our business.
In the Financial Review, we report our global
financial results for 2008 with our comparative
2007 results and we highlight our key
accounting policies and our approach to
financial risk management.
In the Geographical Review, we report on
our global financial performance at a product
level and in different geographical areas, with
our comparative 2007 performance.
The Therapy Area Review provides additional
information about our areas of interest,
including why we are focused on particular
diseases, our goals and our progress towards
achieving them. As part of this, we report in
detail on our pipeline of potential new
products and life-cycle developments of our
marketed medicines.
We highlight the importance of leadership,
effective decision-making and risk
management, and include a summary of
our business organisation and the various
responsibilities and processes in place for
ensuring the integrity of financial information,
internal controls and risk management.
As a global, research-based pharmaceutical
company, we face a diverse range of risks and
uncertainties that may affect our business.
We work continuously to ensure that we have
appropriate and effective processes in place
for identifying, assessing and managing these
risks, in line with our strategic objectives, the
material needs of our stakeholders and our
core values. In the Risk section, we describe
our key risk management and assurance
mechanisms, together with the principal
areas of risks and uncertainties that we
currently consider to be material to our
business. Where relevant, specific risks and
uncertainties are also discussed at various
points throughout this Directors’ Report.
Stakeholder expectations of the industry
regarding corporate responsibility continue
to vary from country to country. Nevertheless,
a global business means global visibility and
there are a number of issues relating to our
business that have the potential to impact
our reputation anywhere in the world. These
include patient safety, access to medicines,
sales and marketing practices, research ethics,
employment practices and the environment.
We provide information throughout this
Directors’ Report about our position on key
issues, and about our approach to managing
the challenges and opportunities associated
with our corporate responsibility to ensure
that we continue to be led by our core values
to achieve sustainable success. Further
information about our commitment to
responsible business, our position on the
issues and our performance is available on
our website, astrazeneca.com/responsibility.
The Shareholder Information and Corporate
Information sections starting on pages 190
and 197 respectively, are incorporated into
this Directors’ Report.
The Glossary and the Market Definition Table
(from page 199) provide a useful guide to
terms, as well as acronyms and abbreviations,
used in this Directors’ Report.
INTRODUCTION
DIRECTORS’ REPORT
9
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
BUSINESS ENVIRONMENT
AstraZeneca operates in a dynamic and
rapidly changing business environment that
presents both opportunities and challenges
for our industry. The most successful
pharmaceutical companies will be those that
are able to manage effectively the risks and
maximise the opportunities through timely
and efficient investment, full use of intellectual
property and constructive engagement
with stakeholders.
The fundamentals of the world pharmaceutical
market remain robust. Although industry
revenue growth is slowing, mainly due to
ever-greater pressure on healthcare costs,
pricing and increased generic competition,
the demand for healthcare that underpins
the industry’s future growth remains strong.
The pharmaceutical industry is arguably less
exposed than other sectors to the current
global economic downturn, although some
impact may result from increased constraints
on payers, suppliers and distributors. At the
same time, there may also be opportunities,
such as strategic partnerships with smaller
companies seeking funding.
WoRld mARkETS
The world pharmaceutical market in 2008
was valued at $689 billion – an increase of
5% at CER (2007: 7%). Overall growth was
constrained by a significant slow-down in the
US even though growth in other Established
ROW was maintained and growth in Emerging
ROW, in particular Emerging Asia Pacific,
was strong.
Despite its slower growth, the US remains the
largest pharmaceutical market in the world,
representing 42% of the global sales total
(2007: 46%). The order of the top ten
countries ranked by market size did not
change in 2008 but, Poland, Australia and
Turkey moved up the overall top 20 rankings.
WoRld RANkINgS By CouNTRy
Growth Growth Market Share Sales
Rank Rank MAT/Q3/08 MAT/Q3/07 MAT/Q3/08 MAT/Q3/08
MAT/Q3/08 MAT/Q3/07 % % % $bn
US 1 1 1 7 42 291
Japan 2 2 4 2 9 65
France 3 3 4 5 6 43
Germany 4 4 6 3 6 42
Italy 5 6 4 4 26
UK 6 5 2 5 3 23
Spain 7 7 8 8 3 23
Canada 8 8 6 7 3 19
China
1
9 9 27 21 3 18
Brazil
2
10 10 12 10 2 13
Turkey
2
11 13 9 18 2 10
South Korea 12 11 11 10 1 10
Australia 13 14 11 8 1 9
Mexico
2
14 12 4 8 1 9
India
2
15 15 13 13 1 7
Poland 16 17 9 8 1 7
Netherlands 17 16 5 8 1 7
Belgium 18 18 8 4 1 6
Greece
2
19 19 12 18 1 6
Sweden 20 20 6 6 1 4
Data based on world retail and hospital pharmacy sales except:
1
Hospital pharmacy only
2
Retail pharmacy only
MAT = Moving Annual Total
Source: IMS Health 2008 MIDAS Quantum
WoRld phARmACEuTICAl mARkETS
Sales Growth Market value
$bn % %
Emerging ROW
2008 108 14 16
2007 87 13 14
2006 74 12 13
Established ROW
2008 271 5 39
2007 232 4 37
2006 211 4 37
North America
2008 310 2 45
2007 304 7 49
2006 284 7 50
Data based on world market sales using AstraZeneca market definitions as set out in the Glossary on page 199.
dEvElopEd mARkETS
Population: 893 million
GDP growth
1
: 2.5%
GDP/CAP
2
: $38,376
Pharma Market: $562 billion
10
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
processes involved in the initiation and
progression of disease. Together with advances
in the technologies for the design and testing
of novel compounds, this is enabling new
opportunities for the delivery of innovative
small molecules as therapeutic agents.
It has been predicted that within the world’s
top 100 products, 44% of sales will come
from products produced using biotechnology,
based on forecasts for 2012. This compares
to only 25% in 2007 and 11% in 2000.
The rate of growth for biologics has been
faster than the small molecule segment in
recent years and this trend is forecast to
continue in the immediate future.
Biotechnology techniques are used to modify
an organism’s genetic material at the cellular
or molecular level to produce biotechnology-
derived products, which include monoclonal
antibodies and vaccines, and are often
referred to as large molecules in comparison
to chemical compounds that are referenced
as small molecules. Biologics are often more
complex to manufacture than small molecule
therapies because they are made by generating
biological material from cells. The regulatory
regimes for ‘biosimilars’ (similar versions of
existing biological products or vaccines) are
less well established than those for generic
pharmaceuticals, although regulatory authorities
in Europe and the US are currently reviewing
approval processes. Difficulties producing an
identical copy of a biological drug mean that,
for biologics, generic competition has been
less prevalent. These factors can help to deliver
longer product life-cycles for biologics
compared to traditional pharmaceuticals.
techniques are leading to an increased
incidence and diagnosis of chronic diseases,
such as cancer and diabetes, which require
long-term management. Chronic disease is
on the increase in middle-income countries
too, and is also beginning to have an impact
in the least developed countries.
Many diseases remain under-diagnosed,
sub-optimally treated or do not have effective
therapies. Projections indicate that global
mortality and the burden of disease will
continue to increase over the next 20 years,
mainly in non-communicable disease areas
3
.
The leading causes of death globally in 2030
are predicted to include ischaemic heart
disease, cerebrovascular disease, chronic
obstructive pulmonary disease (COPD), lower
respiratory infections, lung cancer and diabetes.
At AstraZeneca, we are focused on six therapy
areas: Cardiovascular, Gastrointestinal,
Infection, Neuroscience, Oncology, and
Respiratory and Inflammation, which together
represent a significant proportion of the
worldwide burden of disease. Details about
the therapy environment in each of our areas
of interest are provided in the Therapy Area
Review (page 53).
SCIENCE ANd TEChNology AdvANCES
The demand for healthcare will be met
not only by existing therapies, but also by
innovation resulting from advances in both
the understanding of disease and the
application of new technologies. Small
molecule R&D remains a significant aspect
of the pharmaceutical business, although the
importance of large molecules or biologics
is increasing. Advances in science are paying
back in increased understanding of the key
ThE gRoWTh dRIvERS
Increasing and ageing populations >
in established markets.
Emergence of expanded patient >
populations in new markets.
Continued unmet medical need. >
Continued scientific and >
technological advance.
EXpANdINg pATIENT populATIoNS
The world population has doubled in the last
50 years from three billion to over six billion
and is expected to reach nine billion by 2050.
There are an increasing number of people who
can access the highest standards of healthcare,
especially among the elderly, who represent
a rising proportion of developed nations’
populations. In addition, the fast-developing
economies, such as China and Brazil, continue
to offer new opportunities for the industry
to gain access to an expanding number of
patients who can benefit from medicines.
Emerging markets currently represent 85%
of the world population and 20% of the total
pharmaceutical market. Fuelled by faster
GDP growth than in developed nations,
pharmaceutical industry growth in emerging
markets was in 2008 double the rate of that
in established markets (World Pharmaceutical
Market Values table on page 9).
uNmET mEdICAl NEEd
In most established markets, ageing
populations, more sedentary lifestyles
and the availability of improved detection
EXpANdINg pATIENT populATIoNS
dEvElopEd mARkETS
Population: 893 million
GDP growth
1
: 2.5%
GDP/CAP
2
: $38,376
Pharma Market: $562 billion
EmERgINg mARkETS
Population: 5,638 million
GDP growth
1
: 6.8%
GDP/CAP
2
: $2,564
Pharma Market: $153 billion
1
Real compound annual growth rate for years
2002-2007
2
2007 data
GDP: Gross Domestic Product
CAP: Per Capita
Source: IHS Global Insight
3
Source: WHO statistics 2008.
2000
2005
2006
2007
2008 (f)
2009 (f)
42% 31% 7% 20%
30% 15% 10%21% 24%
48%(1)% 13% 17% 23%
25% 16% 23% 35%1%
12% 17% 32% 36%3%
9% 14% 9%34% 34%
US TOP 5 EUROPE “PHARMERGING” JAPAN ROW
DIRECTORS’ REPORT
11
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
CompETITIoN
Our main competitors are other international,
research-based pharmaceutical companies
that sell innovative, patent-protected,
prescription medicines. Following patent
expiry, our products also compete with
generic pharmaceuticals. Since generic
manufacturers do not bear the same high
costs of R&D, nor do they typically invest
as significantly in safety monitoring or
marketing, they typically adopt lower prices
for their products.
The generic industry is increasingly challenging
innovators’ patents and in the US, the world’s
largest pharmaceutical market, many leading
medicines have faced or are facing patent
challenges from generic manufacturers. The
research-based industry is also experiencing
increased challenges elsewhere in the world,
for example in Europe, Canada, Asia and
Latin America. It is increasingly complex to
enforce patent rights and other intellectual
property in certain markets, especially those
where practices are in place to encourage
broad access to medicines. While there are
few established regulatory systems for
biosimilars of biological products, several
markets, including the US, are considering
regulatory structures that might allow for an
abbreviated marketing approval mechanism
akin to that for generic pharmaceuticals.
Further information about the risk of the early
loss and expiry of patents is explained in the
Intellectual Property section on page 26.
Competition also comes from collaborations
and partnerships between traditional
pharmaceutical companies and smaller
biotechnology and vaccine companies.
Increasingly, as pharmaceutical companies
seek to expand their pipeline, they are able
to gain access to promising new product
candidates by partnering with these smaller
companies that may lack some of the
infrastructure for growth that a larger company
can provide. Competition for high quality
collaborations is increasingly fierce as the
major pharmaceutical companies frequently
focus on the same opportunities to enhance
their in-house capabilities.
Further information about the principal risks
and uncertainties we face can be found in
the Risk section from page 74.
Payers also increasingly require demonstration
of the economic as well as therapeutic value
of medicines. Meeting these needs across
a diverse range of national and local
reimbursement systems requires significant
additional resources.
REgulAToRy REQuIREmENTS
The pharmaceutical industry is one of the
most regulated of all industries and, whilst
efforts to harmonise regulations globally are
increasing, the number and impact of these
regulations continue to grow. Regulatory drug
review and approval is a complex and time
consuming process, typically taking between
six months and two years. In recent years,
regulatory processes have become subject
to more conditions including patient risk
management plans, patient registries,
post-marketing requirements, and conditional
and limited approvals.
Traditional clinical trials designed to establish
safety and efficacy remain a core component
of drug development programmes but
regulators are increasingly requiring that
programmes also clearly demonstrate the
benefits and risks of new medicine in the
context of other available therapies, as well
as demonstrating long-term medical outcomes,
such as survival and quality of life improvements.
In addition to safety and efficacy, pre-approval
regulation covers every aspect of the product
including the chemical composition,
manufacturing, quality controls, handling,
packaging, labelling, distribution, promotion
and marketing. Post approval and launch,
all aspects relating to a product’s safety,
efficacy and quality must continue to meet
regulatory requirements. See also Ensuring
Product Quality (page 27).
ThE ChAllENgES
Continued pressure on the price >
of medicines.
Higher regulatory hurdles for new >
medicines and new indications.
Competition from research-based >
and, increasingly, generic
pharmaceutical companies.
pRICINg pRESSuRE
The growing demand for healthcare means
ever-increasing pressure on healthcare budgets
and, whilst payers recognise the need to
reward innovation, they have a duty to
spend their limited financial resources wisely.
Cost-containment, including pharmaceutical
spending, therefore continues to be a
fundamental consideration. The current global
economic downturn is likely to further constrain
healthcare providers and those patients who
pay directly for their medicines, and additional
challenges may arise if suppliers and
distributors face credit-related difficulties.
The research-based pharmaceutical industry’s
challenge is to manage the associated
downward pressure on the price of its
products, whilst continuing to invest in the
discovery, development, manufacturing and
marketing of new medicines.
Most of our sales are generated in highly
regulated markets where governments exert
various levels of control on price and
reimbursement. The network of pricing
systems creates a complex matrix that
must be managed to optimise revenues.
This may be further complicated by currency
fluctuations within regions. The principal
aspects of price regulation in the major markets
are described more in the Geographical
Review from page 48.
CoNTRIBuTIoN To gloBAl gRoWTh By kEy REgIoNS
“Pharmerging” markets include: China, Brazil, India, South Korea, Mexico, Turkey and Russia.
(f) = forecast – complete 2008 data unavailable at the date of publication of this Report.
Source: IMS Health, Market Prognosis, September 2008.
12
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
ASTRAZENECA IS AN INNOVATION-DRIVEN,
INTEgRATED, glOBAl PhARMACEUTICAl
COMPANy. OUR MISSION IS TO MAkE ThE
MOST MEANINgfUl DIffERENCE TO PATIENT
hEAlTh ThROUgh gREAT MEDICINES, AND
TO CREATE ENDURINg VAlUE fOR OUR
ShAREhOlDERS AND SOCIETy ThROUgh
INDUSTRy-lEADINg R&D PRODUCTIVITy,
COMMERCIAl ExCEllENCE AND
OPERATIONAl EffICIENCy.
Our strategy centres on four main priorities:
strengthen the pipeline, grow the business,
re-shape the business and promote a culture
of responsibility and accountability. These
priorities are described in this table, together
with details of our objectives; the measures
we use to assess our progress; the initiatives
in place to drive achievement of our objectives;
and a summary of our 2008 performance.
STRATEgy, gOAlS AND PERfORMANCE MEASUREMENT
STRATEgIC pRIoRITy oBJECTIvES mEASuRES INITIATIvES 2008 pERFoRmANCE SummARy
STRENgThEN ThE pIpElINE
To be one of the fastest and
most productive companies
in the industry through
continuous improvement in
our research and
development (R&D), coupled
with externalisation to
broaden our research base
and further strengthen our
pipeline of new products.
Achieve a median composite
eight-year product
development cycle by 2010.
Deliver two new molecular
entity (NME) launches on
average per year from 2010.
In order to achieve the above
objective, ensure that we have
10 or more NMEs in Phase III
development by 2010.
Development cycle times and
quality for small molecules
and biologics.
Number of NME launches
per year.
Attrition rates.
Number of development
projects by phase.
Number of in-licensing deals,
alliances and acquisitions.
R&D investment levels.
Improving R&D quality and speed through
leading-edge science, effective risk
management and decision-making,
and overall business efficiency.
Maximising the value of our biologics
business and continuing to build a major
presence in this fast-growing sector.
Investing in external opportunities to enhance
our internal innovation through in-licensing,
alliances and acquisitions.
2008 target exceeded for small molecule development cycle times. See page 19.
NME and life-cycle management progressions delivered. See page 19.
Industry top quartile for speed and cost efficiencies achieved in Discovery. See page 18.
Eight significant regulatory packages delivered, broadening the use of Seroquel, Iressa,
Symbicort and FluMist across several jurisdictions. Two new product submissions delivered.
Overall pipeline volume increased by 5% and in-phase distribution of our projects has improved:
FGLP (32); Phase I (34); Phase II (31); Phase III (10); Life-cycle management (23). See pages 22 to 24.
Over 300 Discovery collaborations/partnerships to access new science and technology platforms.
21 in-licensing deals, alliances and collaborations successfully concluded. See page 19.
R&D investment $5.2 billion.
gRoW ThE BuSINESS
To maintain our position
among the industry world
leaders through a continued
focus on driving commercial
excellence.
Deliver overall sales growth
in line with market growth.
Deliver target sales growth
in key markets.
Ensure profitable launch
of our own and our
in-licensed products.
Sales value growth at CER.
Global sales and prescription
share trends for key products
and key markets.
Number of life-cycle
projects delivered.
Number of successful
launches of new products.
Number of commercial
collaborations secured.
Active and rigorous development of our
brands to maximise patient benefit and
commercial potential.
Driving high standards of sales force
effectiveness, marketing excellence and
customer support.
Building on our leadership positions in
existing markets and expanding our
presence in important emerging ones.
Securing new external commercial
collaborations that further strengthen our
platform for future business growth.
Global sales +3% at CER.
Sales by region at CER: North America +2%; US +1%; Established ROW +2%;
Emerging ROW +16%. See page 48.
Sales by key product at CER: Arimidex +4%; Crestor +26%; Nexium -2%; Seroquel +9%;
Symbicort +22%. See page 2.
Two US co-promotion agreements secured and 12 disposal transactions to extract value from
deprioritised and non-core assets. See page 19.
RE-ShApE ThE BuSINESS
To create an organisation with
the flexibility and financial
strength to adapt quickly and
effectively within a challenging
and rapidly changing
business environment.
Maintain gross profit margin.
Efficiently deliver on
R&D investment.
Achieve upper quartile
industry performance in
relation to selling, general and
administrative (SG&A) costs.
Deliver procurement
savings targets.
Gross margin and operating
margin.
R&D unit cost reduction.
SG&A cost growth rates.
Progress of
productivity initiatives.
Procurement savings.
Continued implementation and expansion of
our restructuring programme, including:
Reviewing supply and >
manufacturing assets.
Driving R&D efficiency. >
Driving sales and marketing resource >
optimisation and customer focus.
Implementing restructuring and efficiency >
programmes in corporate functions.
Core gross margin: 80.4%
Core operating margin: 34.7%
On track to deliver R&D unit cost reduction target of 15% over three years.
Core SG&A cost growth rate: 3%
Restructuring programme continues with benefits now estimated to reach $2.5 billion per annum
(up from $1.4 billion); with $2.1 billion in savings expected before 2010, and the balance to be
realised by 2013.
Procurement savings on track to achieve target.
pRomoTE A CulTuRE oF RESpoNSIBIlITy ANd ACCouNTABIlITy
To create an organisation that
is recognised not only for the
skills, experience and quality
of its people, but also for the
integrity with which it
conducts its business.
Achieve upper quartile
industry ranking for
employee engagement.
Ensure that a culture of
responsible business,
including compliance, is
embedded across all of
our activities.
Ensure that our reputation is
favourable and supports our
continued success.
Employee engagement levels.
Number of confirmed breaches
of external sales and marketing
regulations or codes.
Ranking in Dow Jones World
and STOXX (European)
Sustainability Indexes.
Number of animals used
in research.
Greenhouse gas and
Ozone Depletion Potential
(ODP) emissions.
Accidents with serious
injury and cases of
occupational illness.
Strengthening the effectiveness of leaders
and our performance management.
Maintaining/improving levels of
employee engagement.
Investing in leadership development to
improve accountability and collaboration.
Integrating responsible business
considerations into everyday business
thinking and decision-making.
Global employee survey shows employee engagement is strong, outperforming many other
pharmaceutical companies. See page 28.
15 confirmed breaches of external sales and marketing regulations or codes. See page 15.
Positioned amongst the top 6% of companies in the sector in the Dow Jones World and STOXX
(European) Sustainability Indexes.
376,000 animals used in research (preliminary figures). See page 15.
1.22 million tonnes CO
2
equivalents (39 tonnes/$million sales). See page 15.
22 tonnes ODP emissions (0.71kg/$million sales). See page 15.
2.28 accidents with serious injury per million hours worked. See page 15.
1.04 cases of occupational illness per million hours worked. See page 15.
Directors’ report
13
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
STRATEGIC pRIoRITY oBJECTIVES mEASuRES INITIATIVES 2008 pERFoRmANCE SummARY
STRENGTHEN THE pIpElINE
To be one of the fastest and
most productive companies
in the industry through
continuous improvement in
our research and
development (R&D), coupled
with externalisation to
broaden our research base
and further strengthen our
pipeline of new products.
Achieve a median composite
eight-year product
development cycle by 2010.
Deliver two new molecular
entity (NME) launches on
average per year from 2010.
In order to achieve the above
objective, ensure that we have
10 or more NMEs in Phase III
development by 2010.
Development cycle times and
quality for small molecules
and biologics.
Number of NME launches
per year.
Attrition rates.
Number of development
projects by phase.
Number of in-licensing deals,
alliances and acquisitions.
R&D investment levels.
Improving R&D quality and speed through
leading-edge science, effective risk
management and decision-making,
and overall business efficiency.
Maximising the value of our biologics
business and continuing to build a major
presence in this fast-growing sector.
Investing in external opportunities to enhance
our internal innovation through in-licensing,
alliances and acquisitions.
2008 target exceeded for small molecule development cycle times. See page 19.
NME and life-cycle management progressions delivered. See page 19.
Industry top quartile for speed and cost efficiencies achieved in Discovery. See page 18.
Eight significant regulatory packages delivered, broadening the use of Seroquel, Iressa,
Symbicort and FluMist across several jurisdictions. Two new product submissions delivered.
Overall pipeline volume increased by 5% and in-phase distribution of our projects has improved:
FGLP (32); Phase I (34); Phase II (31); Phase III (10); Life-cycle management (23). See pages 22 to 24.
Over 300 Discovery collaborations/partnerships to access new science and technology platforms.
21 in-licensing deals, alliances and collaborations successfully concluded. See page 19.
R&D investment $5.2 billion.
GRoW THE BuSINESS
To maintain our position
among the industry world
leaders through a continued
focus on driving commercial
excellence.
Deliver overall sales growth
in line with market growth.
Deliver target sales growth
in key markets.
Ensure profitable launch
of our own and our
in-licensed products.
Sales value growth at CER.
Global sales and prescription
share trends for key products
and key markets.
Number of life-cycle
projects delivered.
Number of successful
launches of new products.
Number of commercial
collaborations secured.
Active and rigorous development of our
brands to maximise patient benefit and
commercial potential.
Driving high standards of sales force
effectiveness, marketing excellence and
customer support.
Building on our leadership positions in
existing markets and expanding our
presence in important emerging ones.
Securing new external commercial
collaborations that further strengthen our
platform for future business growth.
Global sales +3% at CER.
Sales by region at CER: North America +2%; US +1%; Established ROW +2%;
Emerging ROW +16%. See page 48.
Sales by key product at CER: Arimidex +4%; Crestor +26%; Nexium -2%; Seroquel +9%;
Symbicort +22%. See page 2.
Two US co-promotion agreements secured and 12 disposal transactions to extract value from
deprioritised and non-core assets. See page 19.
RE-SHApE THE BuSINESS
To create an organisation with
the flexibility and financial
strength to adapt quickly and
effectively within a challenging
and rapidly changing
business environment.
Maintain gross profit margin.
Efficiently deliver on
R&D investment.
Achieve upper quartile
industry performance in
relation to selling, general and
administrative (SG&A) costs.
Deliver procurement
savings targets.
Gross margin and operating
margin.
R&D unit cost reduction.
SG&A cost growth rates.
Progress of
productivity initiatives.
Procurement savings.
Continued implementation and expansion of
our restructuring programme, including:
Reviewing supply and >
manufacturing assets.
Driving R&D efficiency. >
Driving sales and marketing resource >
optimisation and customer focus.
Implementing restructuring and efficiency >
programmes in corporate functions.
Core gross margin: 80.4%
Core operating margin: 34.7%
On track to deliver R&D unit cost reduction target of 15% over three years.
Core SG&A cost growth rate: 3%
Restructuring programme continues with benefits now estimated to reach $2.5 billion per annum
(up from $1.4 billion); with $2.1 billion in savings expected before 2010, and the balance to be
realised by 2013.
Procurement savings on track to achieve target.
pRomoTE A CulTuRE oF RESpoNSIBIlITY ANd ACCouNTABIlITY
To create an organisation that
is recognised not only for the
skills, experience and quality
of its people, but also for the
integrity with which it
conducts its business.
Achieve upper quartile
industry ranking for
employee engagement.
Ensure that a culture of
responsible business,
including compliance, is
embedded across all of
our activities.
Ensure that our reputation is
favourable and supports our
continued success.
Employee engagement levels.
Number of confirmed breaches
of external sales and marketing
regulations or codes.
Ranking in Dow Jones World
and STOXX (European)
Sustainability Indexes.
Number of animals used
in research.
Greenhouse gas and
Ozone Depletion Potential
(ODP) emissions.
Accidents with serious
injury and cases of
occupational illness.
Strengthening the effectiveness of leaders
and our performance management.
Maintaining/improving levels of
employee engagement.
Investing in leadership development to
improve accountability and collaboration.
Integrating responsible business
considerations into everyday business
thinking and decision-making.
Global employee survey shows employee engagement is strong, outperforming many other
pharmaceutical companies. See page 28.
15 confirmed breaches of external sales and marketing regulations or codes. See page 25.
Positioned amongst the top 6% of companies in the sector in the Dow Jones World and STOXX
(European) Sustainability Indexes.
376,000 animals used in research (preliminary figures). See page 20.
1.22 million tonnes CO
2
equivalents (39 tonnes/$million sales). See page 71.
22 tonnes ODP emissions (0.71kg/$million sales). See page 71.
2.28 accidents with serious injury per million hours worked. See page 29.
1.04 cases of occupational illness per million hours worked. See page 29.
8831_AZ_AR08_p07-21_v04_13_02_JHC.indd 13 26/2/09 14:40:12
14
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
Specific measures that our Board and SET
use when assessing business performance,
or that are otherwise judged to be helpful in
enabling shareholders to better understand
and evaluate our business, are described
and illustrated throughout this Report. The
key measures in each of our four main priority
areas are shown in the table on page 12.
In relation to our overall goal of creating
enduring value for shareholders by being
one of the best-performing pharmaceutical
companies, we track shareholder value using
the following financial performance metrics:
sales growth, operating profit and margins;
core and reported earnings per share growth;
net operating cash flow (before debt
repayment and shareholder distributions);
shareholder distributions through dividends
and share re-purchases; and total
shareholder returns. We report our
performance against those measures either
in the Financial Highlights on page 2 or in the
Financial Review from page 31 with total
shareholder return reported on page 184.
mEASuRINg ouR pERFoRmANCE
Each business function is subject to an annual
budget and target-setting process that includes
developing financial and business forecasts,
conducting sensitivity and risk analyses and
setting relevant performance measures.
Reviews are undertaken in each part of the
business in order to monitor and assess
progress against business and budget targets,
and to assess key risks and mitigating actions.
Longer-term, 10-year forecasts are developed
as part of our annual strategy review.
Quarterly internal reports provide the Board
and Senior Executive Team (SET) members
with shared insight into current progress
against short-term financial and non-financial
objectives and current year milestones for
longer-term strategic goals.
Performance is assessed using quantitative,
comparative market, operational and financial
measures and more qualitative analysis.
These measures align with the four main
priorities of our strategy and together they
provide the framework for consistently
monitoring and reporting our progress towards
achieving our objectives and ultimately
delivering enduring shareholder value.
08
07
06
2.28
2.65
2.37
ASTRAZENECA EMPLOYEES: ACCIDENTS WITH
SERIOUS INJURY (PER MILLION HOURS)
1, 2
Core 08
Reported 08
Reported 07
25,408
25,003
23,140
Reported 06 20,916
GROSS MARGIN $M
80.4%
79.1%
78.3%
79.0%
% OF SALES
KEY PRODUCTS
(
ARIMIDEX, CRESTOR, NEXIUM, SEROQUEL AND SYMBICORT
)
BASE PRODUCTS
08
07
06
17,110
(
+9%
)
15,344
(
+11%
)
13,318
(
+23%
)
05 10,849
(
+27%
)
14,491
(
-2%
)
14,215
(
+3%
)
13,157
(
+1%
)
13,101
(
-1%
)
SALES BY KEY AND BASE PRODUCTS $M
31,601
29,559
26,475
23,950
04 8,426
(
+36%
)
13,000
(
-4%
)
21,426
TOTAL
TOTAL
08
07
06
14,785 12,543
14,511 11,491
13,480 10,131
4,273
3,557
2,864
31,601
29,559
26,475
NORTH AMERICA ESTABLISHED ROW EMERGING ROW
SALES BY REGION $M
08
07
06
15
32
44
SALES AND MARKETING: NUMBER OF
CONFIRMED BREACHES
3
Core 08
Reported 08
Reported 07
10,958
9,144
8,094
Reported 06 8,216
OPERATING PROFIT MARGIN $M
34.7%
28.9%
27.4%
31.0%
% OF SALES
08
07
06
1.04
0.99
0.97
ASTRAZENECA EMPLOYEES: CASES OF
OCCUPATIONAL ILLNESS (PER MILLION HOURS)
1
Core 08
Reported 08
Reported 07
4,953
5,179
5,162
Reported 06 3,902
R&D INVESTMENT $M
15.7%
16.4%
17.5%
14.7%
% OF SALES
08
07
06
376
4,5
285
288
NUMBER OF ANIMALS USED
IN RESEARCH ’000
DIRECTORS’ REPORT
15
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
gREENhouSE gAS EmISSIoNS
1
2008 2007 2006
CO
2
-equivalents (million tonnes) 1.22 1.29 1.31
Index (tonnes/$million sales) 39 44 50
Figures are calculated in line with the Greenhouse Gas (GhG) Protocol guidance (ghgprotocol.org)
oZoNE dEplETIoN poTENTIAl EmISSIoNS
1
2008 2007 2006
CFC11-equivalents (tonnes) 22 36 40
Index (kg/$million sales) 0.71 1.2 1.5
Source data for calculation of CFC figures is AstraZeneca sales data
1
Data excludes MedImmune.
2
With and without days lost.
3
Of codes or regulations ruled by external bodies.
4
Data includes MedImmune, KuDOS and Arrow Therapeutics.
5
Preliminary figures. Final data will be available end March 2009 on astrazeneca.com/responsibility.
REPORTINg OUR PERfORMANCE – NON-fINANCIAl
REPORTINg OUR PERfORMANCE – fINANCIAl
16
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
AstraZenecas continued success depends
on focused delivery of our strategy, responding
effectively to the challenges of our rapidly
changing business environment and
successfully identifying and harnessing
opportunities to strengthen the value of our
contribution to healthcare and society.
This section describes the resources, skills
and capabilities that we have in place to
drive delivery of our strategic goals and
keep AstraZeneca at the forefront of positive
change within the industry.
Underpinning all of our activity is our
commitment to innovative collaboration,
focused on a common goal: better health.
This means engaging and working with our
stakeholders to gain the insights we need to
maintain a flow of new, targeted and valued
medicines. It means working in effective teams
internally and in external partnerships that
complement and strengthen our own
capabilities. It also means active participation
in the debate on issues that impact our
business and shape our operating environment.
mEdICINES
Backed by our 70-year track record of
pharmaceutical innovation, we have a broad
range of marketed medicines that continue
to make a positive difference in important
areas of healthcare. We actively and
rigorously develop our brands to bring
further benefit for patients and maximise
their commercial potential.
Our range of medicines is highly competitive
and includes 11 products each with annual
sales of over $1 billion. Our business growth
in the short to medium term is being driven by
Arimidex, Crestor, Seroquel and Symbicort.
Together with Nexium, these five key products
provide the platform for our continued success
whilst we enhance our pipeline for the future.
Our medicines are testament to the skills
of our scientists and our commitment to
working closely with physicians, patients and
other stakeholders to understand what they
need and what they value. Such relationships
have helped us develop families of medicines
– generation by generation – such as the
hormone-based cancer treatments we have
discovered since the 1970s, including Nolvadex
(tamoxifen), Zoladex, Casodex, Arimidex and
Faslodex. Among other benefits, these have
played a part in increasing the five year
survival rate for women with breast cancer
from under 70% 50 years ago to around
90% today.
We introduced the world’s first proton
pump inhibitor, Losec/Prilosec in 1988
a breakthrough in the treatment of gastro-
oesophageal reflux disease – and we have
since developed an improved therapy, Nexium,
which provides healing and symptom relief in
more patients in a shorter time.
Even after a new medicine is launched,
we continue to explore all the ways it can be
used to maximise patient benefit. We have
clearly defined development management
programmes for our marketed products
designed to optimise both the benefit they
bring to patients’ lives and their commercial
potential within the timeframe that patent
protection is available to us.
For example, Crestor, our statin for lowering
cholesterol levels has been used to treat over
14 million people since its launch in 2003.
Studies in recent years have shown that
not only does Crestor reduce cholesterol,
it also slows the progress of atherosclerosis,
or “hardening of the arteries”. In 2008, a major
study reported that Crestor significantly
reduced major cardiovascular events by 44%
in patients with normal cholesterol levels but
with other high risk factors.
Similarly, we first introduced Seroquel as
a treatment for schizophrenia, and our
subsequent studies have shown that it is
also effective in treating both the manic and
depressive dimensions of bipolar disorder.
Recent clinical development has also been
undertaken for the use of Seroquel in treating
major depressive disorder and general anxiety
disorder. Launched in 1997, Seroquel is now
the most commonly prescribed atypical
anti-psychotic in the US.
We also continue to develop better ways
in which our medicines can be used.
Our Symbicort Maintenance and Reliever
Therapy (Symbicort SMART ) is the first
asthma treatment regime to combine both
regular maintenance and as-needed reliever
therapies – allowing patients to control daily
symptoms and reduce asthma attacks using
one inhaler, instead of the usual two or more.
In another development, Symbicort is also
now used to treat chronic obstructive
pulmonary disease (COPD).
Our acquisition of MedImmune in 2007 brought
some significant biological products into our
portfolio. Synagis is the standard of care for
respiratory syncytial virus (RSV) prevention
and has been administered to over one
million premature babies around the world to
help protect them from serious RSV disease.
FluMist, the first intranasal influenza vaccine
to be approved in the US, represents the
first innovation in flu vaccination in more than
60 years.
Further information about all our major
products can be found in the Therapy Area
Review on page 53.
ENSuRINg pATIENT SAFETy
The safety of the patients who take our
medicines is a fundamental consideration.
All drugs have potential side effects and we
aim to minimise the risks and maximise the
benefits of each of our medicines, throughout
their discovery, development and beyond.
After launch, we continually monitor the use
of all our medicines to ensure that we become
aware of any side effects not identified during
the development process and to ensure
that accurate, well-informed and up-to-date
information concerning the safety profile of
our drugs is provided to regulators, physicians,
other healthcare professionals and, where
appropriate, patients. Clinical trials, although
extensive, cannot replicate the complete
range of patient circumstances and rare side
effects can often only be identified after a
medicine has been launched and used in far
greater numbers of patients and over longer
periods of time. We have comprehensive and
rigorous pharmacovigilance systems in place
for detecting and rapidly evaluating such
effects, including mechanisms for highlighting
those that require immediate attention.
We have an experienced, in-house team of
around 500 clinical patient safety professionals
working around the world who are dedicated
to the task of ensuring that we meet our
commitment to patient safety. Each of our
products (whether in development or on
the market) has an assigned Global Safety
Physician who, supported by a team of
Patient Safety Scientists, is responsible for
that product’s continuous safety surveillance.
Patient Safety Managers in each of our national
companies have local responsibility for product
safety within their respective countries.
Our Chief Medical Officer (CMO) has overall
accountability for the benefit/risk profiles of the
products we have in development and those
on the market. The CMO provides medical
oversight and ensures that appropriate risk
assessment processes are in place to enable
informed decisions to be made about safety
as quickly as possible.
RESOURCES, SkIllS AND CAPABIlITIES
DIRECTORS’ REPORT
17
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
Our commitment to patient safety includes
ensuring the security of our medicines
throughout their manufacture and supply.
We continuously monitor our business
environment to identify any new or emerging
product security risks and work to ensure that
these are managed quickly and effectively.
In addition to our internal processes, we also
work with regulatory authorities, government
agencies, trade associations and law
enforcement agencies to combat the growing
threat of counterfeiting. Further details of
the ways in which we manage the risk of
counterfeiting can be found in the Principal
Risks and Uncertainties section from page 76.
hoW WE pRICE ouR mEdICINES
Despite significant advances in healthcare
in recent decades, many diseases are still
under-diagnosed or not well treated, or there
is not yet an effective therapy. Continued
innovation is required to address these unmet
medical needs. At the same time, the growing
demand for healthcare, driven by people
living longer, increasing populations and the
emergence of new economies, means ever
greater pressure on the payers’ budgets.
At AstraZeneca, our challenge is to balance
the associated downward pressure on
the price of medicines with the cost of the
continued innovation that brings benefit for
patients and society.
When setting the price of a medicine, we take
into consideration its full value to patients,
to those who pay for healthcare and to
society in general. Our pricing also takes
account of the fact that, as a publicly owned
company, we have a duty to ensure that we
continue to deliver an appropriate return on
investment for our shareholders. We balance
many different factors, including ensuring
appropriate patient access, in our global
pricing policy, which provides the framework
for optimising the profitability of our products
in a sustainable way.
We continually review our range of medicines
(both those on the market and in the pipeline)
to identify any that may be regarded as
particularly critical to meeting healthcare needs
– either because they treat diseases that are
(or are becoming) prevalent in developing
countries, or because they are potentially
a leading or unique therapy addressing an
unmet need and offering significant patient
benefit in treating a serious or life-threatening
condition. In such cases, we aim to provide
patient access to these medicines through
expanded patient access programmes.
We also support the concept of differential
pricing in this context, provided that safeguards
are in place to ensure that differentially priced
products are not diverted from patients who
need them, to be sold and used in more
affluent markets.
BRINgINg ECoNomIC AS WEll
AS ThERApEuTIC BENEFIT
Our medicines play an important role in
treating serious disease and in doing so
they bring economic as well as therapeutic
benefits. Effective treatments can help to save
healthcare costs by reducing the need for
more expensive care, such as hospital stays
or surgery. They also contribute to increased
productivity by reducing or preventing the
incidence of diseases that keep people away
from work.
RESEARCh ANd dEvElopmENT
R&d STRATEgy
Our R&D strategy is geared to maintaining a
flow of new products that will deliver sustained
business growth in the short, medium and
long-term.
In the short-term, we have continued to build
on the good growth achieved in 2007. Our
overall portfolio volume has grown by 5% and
our in-phase distribution of the projects has
improved. Phase III volumes have remained
constant and our Phase II portfolio has grown
by over 50% (20 to 31) during 2008.
Notable successes in the life-cycle
management (LCM) of our key marketed
products during the year included eight
significant submissions and three approvals
in the US and/or the EU, which are described
in the Therapy Area Review commencing on
page 53.
In the medium-term, we will continue to drive
our pre-clinical and clinical Phase I and II
projects towards proof of concept as rapidly as
possible. In line with our ongoing externalisation
strategy, we continue to look beyond our
own laboratories, and actively seek alliances
and acquisitions with external partners to
gain access to leading drug projects or
technology platforms.
The progress we are making in our drive
to increase productivity is reflected in the
delivery of projects from discovery and the
growth of our early development portfolio.
We have introduced a more rigorous and
consistent measure for the number of
compounds reaching development and now
record additions to the pipeline from the first
pre-clinical study conducted for regulatory
approval purposes (First Good Laboratory
Practice (FGLP)) instead of when a candidate
drug is simply nominated for development.
During 2008, 32 FGLPs were selected for
development (compared with 36 in 2007).
Further details are set out in the Development
Pipeline table on pages 22 to 24.
dISEASE AREA STRATEgIES
Our disease area strategies are established
using a regular review process that centres
on the evaluation of research opportunities
against a set of consistent criteria, including
unmet medical need, commercial and
scientific opportunity, competitive position
and alignment with our capabilities. Our R&D
Executive Committee (further details of which
are set out on page 21) uses the reviews to
determine the levels of investment we will
make in different disease areas. The process
also enables us to deploy our resources in
the best way to meet our commercial and
scientific objectives.
Our New Opportunities Team, operating from
pre-clinical through development, generates
more value from disease mechanisms and
compounds through both internal efforts and
external alliances with the aim to transform
them into profitable, innovative therapies.
In addition, the New Opportunities Team will
consider a broad range of pre-clinical to late
stage development opportunities. This includes
identification of compounds that help address
side effects and complications in disease
areas we have prioritised, and of opportunities
that enable rapid entry into breaking new
disease areas via strategic alliances, in order
to provide additional assets for our pipeline
and the delivery of profitable growth.
ouR RESouRCES
AstraZeneca’s research effort spans a range
of different disciplines and locations, but our
scientific community shares a common goal:
to deliver new and innovative medicines to
patients as quickly, efficiently and safely as
possible. They work together across national
boundaries and sites to exchange ideas,
promote best practice and maximise the
scientific potential offered by our size and
global reach.
We have a global R&D organisation, with
around 12,000 people at 17 principal centres
in eight countries. Our main small molecule
facilities are in the UK (Alderley Park,
Macclesfield and Charnwood); Sweden (Lund,
MöIndal and Södertälje); and the US (Boston,
Massachusetts and Wilmington, Delaware).
Other sites which have a focus on discovery
18
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
We believe that one of the reasons for our
productivity success in Discovery over the
past five years is because we have taken a
long-term view and maintained consistency
of focus over time on our strategic objectives.
Latest industry benchmarks indicate that our
speed and cost-effectiveness in Discovery
have moved into the top quartile, while our
delivery of candidate drugs this year exceeded
our targets despite managing significant
change across the organisation.
dISCovERy mEdICINE
Discovery medicine (the collaboration between
clinical medicine and basic science) helps us
gain a better understanding of human diseases
and the suitability of future medicines to treat
those diseases, as well as identify and deploy
biomarkers (a biological factor or measure
that can be used to quantify the progress of
a disease and/or the effects of a treatment)
which can help us to make early decisions on
the effectiveness and safety of our compounds
in clinical development. All compounds
nominated for development now have a
biomarker strategy although it is not always
easy to identify a marker for each molecule.
SAFETy ASSESSmENT
Safety assessment is a critical aspect of all our
research and we implement high-throughput
testing of safety early in the process of
prioritising and selecting the best compounds
for progression. Recent process improvements
have reduced attrition due to safety issues
and cut the time taken to deliver key safety
studies, without compromising quality
allowing more rapid entry to testing in man.
which opened in 2007. The Centre is focused
on translational medicine in cancer, a major
cause of death in China. In addition, Process
R&D has further expanded its capability in
Bangalore as it moves to optimise the capital
investment at this site in recent years.
dISCovERy RESEARCh
In discovery research, we analyse many
thousands of compounds for their potential
to become a new medicine. Only a few make
it through the various, increasingly demanding,
stages of discovery research through which
we identify the most promising candidates for
clinical development. Our discovery teams
work closely with clinical and development
teams to prioritise their activities in line with
our disease area strategies.
We continue to improve the quality of chemical
leads and biological targets so that we
can eliminate, at an early stage, those
compounds that are unlikely to make it
through development. We have invested in
a number of key academic collaborations
to identify potential new targets, disease
mechanisms and technology platforms.
For example, collaborations with Melior
Discovery (Exton, Philadelphia, US) and
Graffinity Pharmaceuticals (Heidelberg,
Germany) help us to identify more rapidly
those high quality, novel compounds which
have the potential to proceed rapidly through
discovery into clinical development. In addition
we have continued to increase the speed and
efficiency of our drug discovery processes
using Lean Sigma
approaches.
research are in Canada (Montreal, Quebec);
France (Reims); India (Bangalore); China
(Shanghai); and the UK (KuDOS and Arrow
Therapeutics’ sites). We have a clinical
development facility in Osaka, Japan.
Our principal sites for biologics and vaccines
are in the US (Gaithersburg, Maryland and
Mountain View, California) and the UK
(Cambridge). Substantially all of our
properties are held freehold, free of material
encumbrances and we believe such
properties are fit for their purposes.
In 2008, we invested $5.2 billion in R&D
(2007: $5.2 billion; 2006: $3.9 billion),
$101 million on externalisation and approved
$308 million of R&D capital investment to
strengthen our resources in line with our
strategic objectives. Major capital commitments
made in previous years continue to progress
as planned. In Boston (US), we have continued
to enhance our infection research capability,
and at Macclesfield (UK) ongoing work is
focused on expanding and improving our
Process R&D laboratories. New investments
in 2008 included the replacement and
consolidation of Pharmaceutical & Analytical
R&Ds high potents manufacturing facilities at
Charnwood (UK), and a major construction
project to provide a new biologics services
facility at Alderley Park (UK).
As part of our strategic expansion in important
emerging markets, we continue to strengthen
our research capabilities in Asia. Investment
continued during 2008 at our ‘Innovation
Centre China’ research facility in Shanghai,
“2008 has been a milestone year for our
R&D organisation. We are discovering and
developing effective medicines faster than
ever before and the considerable progress
we have made in reducing development
cycle times and costs has been achieved
without compromising on quality.
Our review of our disease area strategies
and deployment of resources to the best
opportunities led us to modify our therapeutic
area strategy during the year and to stop
discovery work in osteoarthritis to allow us
to increase our commitment to biologics.
Coupled with a productive licensing activity,
we have now created a more balanced
portfolio of high quality small molecule and
biologics projects that present a strong
platform for continued success in important
areas of unmet medical need.
During 2008, we delivered eight significant
regulatory packages in several jurisdictions to
broaden the use of our marketed products,
Seroquel, Symbicort, Iressa and FluMist;
as well as two new product submissions
for motavizumab and Onglyza
. We have
strengthened our mid-stage pipeline
and maintained 10 projects in Phase III
development. 32 projects entered the
pipeline during the year and 44 projects
were progressed to their next phase of
development. We have a total of 144
projects in the pipeline – an increase of
seven compared with 2007.
I believe that AstraZeneca is well placed
to maintain this rate of progress, backed
by our clear strategy for R&D, our drive for
continuous improvement, and an R&D
leadership committed to delivery of our
scientific and commercial objectives.”
JohN pATTERSoN CBE FRCp
Executive Director, Development
2008
2007
2006
2005
2004
46 34
41
23
17
17
31 10 23
42 1020 24
49 18 5 25
45 13 256
31 13 255
PRE-CLINICAL PHASE I PHASE II PHASE III LINE EXTENSIONS
PRE-CLINICAL CLINICAL
DIRECTORS’ REPORT
19
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
We have around 30 biological product
candidates in our development pipeline,
backed by leading-edge technologies and
R&D capabilities that cover a broad range
of approaches to targeting disease across
a range of therapy areas. These include
antibodies, antibody derivatives, therapeutic
proteins, peptides, RNA interference
technologies and various types of live
attenuated and sub-unit vaccines.
We also have a world-leading drug discovery
platform, based on advanced technology
for rapidly isolating human monoclonal
antibodies using phage and ribosome display
and a significant in-house manufacturing
capacity and capability, including expertise in
high-yield purification process and analytical
development resources.
Our strategic objective is to generate eight
compounds entering pre-clinical phase
per year, on a steady-state basis, which
we anticipate will translate into six new
investigational drugs per year.
EXTERNAlISATIoN
Our externalisation strategy continues to
focus on enhancing our internal innovation
through investment, external partnerships,
alliances and acquisitions that further
strengthen our pipeline of new products
and our Strategic Planning and Business
Development (SPBD) team works closely
with R&D, global marketing and finance
teams to deliver these objectives.
We have completed over 40 major
externalisation deals in the last two years,
including the acquisitions of MedImmune
and Arrow Therapeutics in 2007, as well as
numerous smaller deals to enhance and
strengthen the overall health of the portfolio.
We believe that every collaboration is unique,
and we work with potential partners to
structure deals that leverage each party’s
capabilities and assets. Major transactions
in the last two years have included the
in-license of rights to Cubicin
(an antibiotic)
from Cubist in certain geographies and a
co-development and co-commercialisation
agreement with Abbott for a combination of
Crestor and Trilipix
. We recently extended
our co-development and co-commercialisation
agreement with Bristol-Myers Squibb Company
regarding saxagliptin (Onglyza
) and
dapagliflozin (two products in development for
the treatment of Type 2 diabetes) to include
dapagliflozin in Japan. We also concluded
an exclusive worldwide agreement with
MAP Pharmaceuticals to develop and
commercialise Unit Dose Budesonide (UDB),
MAP Pharmaceuticals’ proprietary nebulised
formulation of budesonide.
The initiatives we have in place to deliver
significant productivity improvements by 2011
are making excellent progress and all are on
track. These include:
The change programme that resulted >
from our disease area strategy review
during 2007 was completed in 2008 with
anticipated financial benefits of over $100
million to be delivered by the end of 2009.
During 2008, we centralised and >
outsourced our clinical data handling
to our external partner, Cognizant.
This has enabled us to simplify our
processes, promote consistency and
drive resource efficiencies across our data
management. These improvements are
also helping to speed our internal data
interpretation and decision-making.
Our re-organisation of the Pharmaceutical >
and Analytical R&D function aims to
improve productivity and meet the demands
of an increasingly strengthened pipeline
better by changing working processes,
while retaining our focus on innovation. For
example, we have been able to progress
a larger number of early projects by
reducing the resource per project by more
than 50% since 2004. The function has
also downsized by 10% while introducing
these productivity improvements.
Streamlining of our regulatory function >
exceeded the target 18% reduction in
headcount achieving a 21% reduction
by June 2008.
BIologICAl pRoduCTS
We have a significant biologics business with
proven end-to-end capabilities from discovery
to commercialisation brought together in 2007
under the brand name of MedImmune. As is
the case for small molecules, the discovery
and development strategy for our biologics
business is determined by the R&D Executive
Committee, as is the funding allocation from
the overall R&D budget.
dEvElopmENT
In development, we focus on ensuring that
our expanding range of potential medicines
is developed effectively to meet the needs
of patients and regulators. Project teams
bring together all the relevant skills and
experience needed for the rapid progress
of new medicines, the management of
development risks, and ensuring that quality
and safety remain fundamental considerations
at every stage.
We have a wide range of compounds in
early development, and a total of 34 projects
in Phase I, 31 projects in Phase II and 10
projects in Phase III development and are
running 23 life-cycle management projects.
Throughout 2008, we have continued to
focus on improving quality and speeding the
progression of early phase projects along the
development pipeline to market. Backed by
reduced timelines across the whole small
molecule development process, Phase I
cycle times have halved since 2006 and over
the last three years the composite product
development cycle time has now been
reduced by approximately two years.
With the adoption of Lean Sigma
methodology and the implementation of best
practice solutions, we have eliminated the lost
time between key steps in the development
process and we again exceeded our targets
for development cycle times in 2008 for our
small molecules. We believe that we are
well placed to achieve our target of median
composite development cycle times of
eight years by 2010, based on the projects
currently in development. Importantly, we
have in recent years established a culture of
continuous improvement that should sustain
the momentum behind our initiatives for
increased speed, with better quality, and
with improved efficiency.
dEvElopmENT pRoJECTS – NCEs ANd lINE EXTENSIoNS
20
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
The number of animals we use each year
varies according to the amount of pre-clinical
research we are doing and the complexity
of the diseases under investigation. As we
continue to expand our discovery research
activity, our ongoing challenge is to ensure
that our use of animals is minimised
without compromising the quality of the
data. We believe that, without our active
commitment to the 3Rs, our animal use
would be much greater.
We continue to develop our data capture
processes to incorporate companies recently
acquired by AstraZeneca and our animal
numbers for 2008 now include MedImmune,
Arrow Therapeutics and KuDOS.
In 2008, AstraZeneca used approximately
347,000
1
animals in-house (2007: 271,000).
In addition, approximately 29,000
1
animals
were used by external contract research
organisations on our behalf (2007: 13,500).
Around 93% of the animals used in 2008
were rodents, 4% were fish and amphibians
and the remaining 3% included chickens,
rabbits, dogs, ferrets, primates, pigs and
sheep. We also use genetically modified mice
and rats to understand better the genes
involved in human disease. In 2008, these
accounted for approximately 13% of our total
rodent use.
We only use primates in circumstances where
no other species or non-animal methods can
provide the safety or clinical benefit information
that we are seeking in a study, and where
the outcomes of the study are likely to bring
significant advances for the development of
new medicines. Our expanding biologics
capability means that we will be increasing
our primate use over time, particularly in
the development of monoclonal antibodies
targeted at important areas such as cancer
and respiratory disease. Monoclonal antibodies
are highly specific to human physiology, so
primates are in most cases the only relevant
animal model because of their similarity to
humans.
AstraZeneca does not conduct or outsource
work using wild caught primates or great
ape species. In the future, in the rare case
where there is no credible alternative model,
exceptions may be considered but this
will require rigorous secondary ethical and
scientific reviewin addition to our normal
review processes – to challenge the need
for the study, followed by appropriate Board
level approval.
When conducting a trial anywhere in the world,
we operate to the highest of the standards
required by the external international, regional
or local regulations, and our own internal
standards. We have strict guidelines to ensure
that those taking part are not exposed to
unnecessary risks; that they understand
the nature and the purpose of the research;
that proper procedures for gaining informed
consent are followed (including managing any
special circumstances such as different levels
of literacy); and that appropriate confidentiality
rules are applied.
Whilst all AstraZeneca clinical studies are
designed and finally interpreted in-house,
some of them are run for us by external
organisations. The percentage of studies
we place with third parties varies, depending
on the number of trials we have underway
and the amount of internal resource available
to do the work. We contractually require all of
our suppliers to work to the same standards
that we apply in-house. In 2008, around
26% of patients in our global studies were
monitored by external contract research
organisations on our behalf.
During 2008, we extended the scope of our
clinical trials disclosure to include information
about the registration and results of all
AstraZeneca sponsored clinical trials for all
products in all phases, including marketed
medicines, drugs in development and drugs
whose further development has been
discontinued. We make information available,
irrespective of whether the results are
favourable or unfavourable to AstraZeneca,
on public websites including our own
dedicated website, astrazenecaclinicaltrials.
com. At the end of 2008, we had registered
over 800 trials and published the results of
more than 500 trials.
Animal research
Our pre-clinical research includes animal
studies, which continue to play a vital role.
They provide essential information, not
available through other methods, about the
effects of a potential new therapy on disease
and the living body. Regulatory authorities
around the world also require safety data
from pre-clinical testing in animals before
a new medicine can be tested in man.
All our research using animals is carefully
considered and justified and, backed by
our global policies, we continue to drive
the application of the 3Rs (Replacement,
Reduction and Refinement of animal studies)
across our research activity.
Important early stage collaborations have
included deals with Argenta and Silence
Therapeutics and more recently with
Columbia University in the US regarding both
cardiovascular and neurology opportunities.
Additionally, we have also formed a significant
number of early stage partnerships to ensure
that we have access to the latest science
and technology.
Our externalisation strategy is not restricted
to securing in-licensing deals and research
or commercial collaborations. It represents
an important component of our efforts to
maximise value from our portfolio and
incorporates value creation through disposal.
To that end, we have completed a number
of out-licensing transactions and disposals
in 2008, including the transfer out of assets
relating to certain gastrointestinal projects to
create a new entity, Albireo. We also concluded
a fostering agreement with Cancer Research
UK under which they will conduct the early
development of an Src Kinase Inhibitor at
their own cost with AstraZeneca retaining
options on the product upon completion
of certain development milestones.
We continue to strengthen our biologics
capability through externalisation and
completed a number of significant transactions
during 2008 including deals with Direvo
Biotech and SBI Biotech Co.
During 2008 we broadened the scope of
activity by MedImmune Ventures, a captive
venture capital fund, set up to access
leading-edge technology emerging within the
biotechnology world. MedImmune Ventures
will now seek opportunities on a more global
basis to stay at the forefront of novel science
accessing the most innovative start-ups
in biotechnology.
R&d ETHICS
In our search for new medicines for important
areas of healthcare, we are committed to
innovative, high quality science, conducted
to high ethical standards. Compliance with
relevant laws and regulations is a minimum
baseline and underpins our own global
principles and standards, as outlined in our
Bioethics Policy.
Clinical trials
Most of our clinical trials are global in nature
because studies conducted across a broad
geographic span enable us to represent more
fully the diversity of the patient populations
for whom the new medicine is intended.
1
Preliminary figures. Final data will be
available end March 2009 on our website,
astrazeneca.com/responsibility
8831_AZ_AR08_p07-21_v04_13_02_JHC.indd 20 26/2/09 15:02:58
DIRECTORS’ REPORT
21
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
To conduct a portfolio review process >
to evaluate all potential new medicines
within the business to ensure resource
prioritisation and delivery in line with that
process. In particular, this process is
intended to ensure that internal and
external opportunities are reviewed using
the same criteria and that there is a clear
externalisation strategy, aligned with and
complementary to, the disease area
strategies, the internal portfolio and local
market needs.
The R&D Executive Committee currently
comprises the Executive Vice-President,
Discovery Research; the Executive Vice-
President, Development; the Executive
Vice-President, Research and Development,
MedImmune; the Executive Vice-President,
Clinical Research and Chief Medical Officer,
MedImmune; the Chief Executive Officer,
North America and Executive Vice-President,
Global Marketing and the President of
MedImmune; the Senior Vice-President,
Strategic Planning and Business
Development; the Vice-President, R&D
Finance; and the Vice-President,
Development Projects.
AstraZeneca is one of nine partners in
a European Framework Research VI
programme and is a founding member of
the public-private partnership, Stem Cells
for Safer Medicines, in the UK, which brings
together academia, government and members
of the pharmaceutical industry to broaden
the approach to understanding this complex
area of research.
Further information about our commitment
to responsible research is available on our
website, astrazeneca.com/responsibility.
R&d EXECuTIvE CommITTEE, govERNANCE
ANd poRTFolIo mANAgEmENT
The R&D Executive Committee oversees and
prioritises our portfolio of both small molecule
and biological discovery and development
projects from across the Group (whether
originating from our own R&D activities or
from external sources). On an annual basis
it takes a view across all therapy areas and
makes decisions based on unmet therapeutic
need, commercial and scientific opportunity,
competitive position and capability mix.
It is also charged with overseeing a portfolio
review process intended to ensure that internal
and external opportunities are reviewed using
the same criteria and that there is a clear
externalisation strategy aligned with the
disease area strategies.
The Committee has the following
accountabilities:
To establish a series of disease area >
strategies through joint therapy area
strategy teams and to bring them together
into a single AstraZeneca portfolio across
small molecules and biologics.
To develop enabling strategies to ensure >
the optimal delivery of the disease area
strategic targets, including technology
strategies, capital expenditure, capability
mix, shape and size and geographic
footprint of the R&D organisation.
To work with the Chief Executive Officer >
and Chief Financial Officer to agree an
overall R&D budget for AstraZeneca and,
within the R&D Executive Committee,
allocate that budget to discovery and
development activities across small
molecules and biologics.
The welfare of the animals we use continues
to be a top priority. Qualified veterinary staff
are involved in the development and
implementation of our animal welfare
programmes and everyone working with
laboratory animals is trained and competent
in their allocated responsibilities.
As well as mandatory inspections by
government authorities, we have a formal
programme of internal inspections carried out
by our own qualified staff. External contract
research organisations that conduct animal
studies on AstraZeneca’s behalf are also
required to comply with our ethical standards,
and we conduct regular inspections to
ensure our requirements are being met.
Stem cell research
As a company whose success is built on
leading-edge science, we continuously monitor
and assess new research capabilities to identify
opportunities that could help us deliver better
medicines for patients worldwide. We believe
that human embryonic stem cell research
may present such an opportunity.
Because this is a relatively new area for us
and because we do not yet have all the
necessary skills and technologies in-house,
we are working with external partners who
have the capabilities and expertise, and an
ethical commitment consistent with our own.
Some significant progress has been made,
with some promising results, but more work
is needed to understand the full potential of
this type of research.
Our Bioethics Policy demands compliance
both with external legislation, regulations
and guidelines, and with our own codes of
research practice, which include essential
criteria that must be met before any such
research is undertaken. Similar to those that
govern inclusion in public stem cell registries
such as the UK Registry and the US National
Institute of Health Registry, these criteria
require that the stem cells must have been
derived from a fertilised egg that was created
for reproductive purposes, that the fertilised
egg must no longer be needed for these
purposes and that fully informed consent
(with no financial inducements) must have
been obtained for the donation of the
fertilised egg for scientific research. These
requirements apply to all internal work and
external research carried out on our behalf.
22
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
DEVELOPMENT PIPELINE AT 29 JANUARY 2009
Estimated filing date
Therapy area Compound Mechanism Areas under investigation
MAA NDA
phASE I NCEs
Cardiovascular
AZD6482 PI3K-beta inhibitor thrombosis
AZD4017 11BHSD inhibitor diabetes/obesity
Gastrointestinal
AZD2066 metabotropic glutamate receptor 5 antagonist GERD
AZD1386 vanilloid receptor antagonist GERD
Infection
MEDI-534 RSV/PIV-3 vaccine intranasal immunisation
MEDI-560 PIV-3 vaccine intranasal immunisation
MEDI-566 pandemic influenza virus vaccine pandemic influenza vaccine
AZD9639 (MEDI-564)
1
RSV F protein inhibitor RSV treatment
CMV Vaccine CMV vaccine cytomegalovirus
MEDI-557 YTE – extended half-life RSV MAb RSV prophylaxis
MEDI-559 RSV vaccine RSV treatment
Neuroscience
AZD5904 myeloperoxidase (MPO) inhibitor multiple sclerosis
AZD3241 myeloperoxidase (MPO) inhibitor Parkinson’s disease
AZD2066 metabotropic glutamate receptor 5 antagonist chronic neuropathic pain
AZD6280 GABA receptor subtype partial agonist anxiety
TC-5619
1
neuronal nicotinic receptor agonist cognitive disorders in schizophrenia
AZD8529 glutamatergic modulator schizophrenia
AZD2516 metabotropic glutamate receptor 5 antagonist chronic neuropathic pain
AZD1446 neuronal nicotinic receptor agonist Alzheimer’s disease
AZD7268 enkephalinergic receptor modulator depression/anxiety
Oncology
AZD8931 erbB kinase inhibitor solid tumours
AZD7762 CHK1 kinase inhibitor solid tumours
AZD8330 (ARRY-424704)
1
MEK inhibitor solid tumours
CAT-8015 recombinant immunotoxin haematological malignancies
MEDI-538
1
CD19 B cells leukaemia/lymphoma
AZD8055 TOR kinase inhibitor range of tumours
AZD6918 TRK inhibitor solid tumours
AZD4769 EGFR tyrosine kinase inhibitor solid tumours
Respiratory &
Inflammation
Pneumococcal vaccine
1
pneumococcal vaccine Streptococcus pneumoniae
CAM-3001 anti-GM-CSFR rheumatoid arthritis
AZD8848 asthma
AZD8566 CCR5 rheumatoid arthritis
AZD8075 CRTh2 antagonist asthma/COPD
AZD5985 CRTh2 antagonist asthma/COPD
1
Partnered product.
DIREcTORs’ REPORT
23
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
phASE III/REgISTRATIoNS: NCEs
Cardiovascular Onglyza
™1
DPP-4 inhibitor diabetes Filed Filed
Brilinta (A ZD6140) ADP receptor antagonist arterial thrombosis 4Q 2009 4Q 2009
Crestor/Trilipix
™1
statin + fibrate fixed combination dyslipidaemia 3Q 2009
Dapagliflozin
1
SGLT2 inhibitor diabetes 2H 2010 2H 2010
Infection Motavizumab humanised MAb binding to RSV F protein RSV prevention TBD Filed
Neuroscience PN400
1
naproxen + esomeprazole signs and symptoms of OA, RA and AS 4Q 2009 Mid 2009
Oncology
Zactima VEGFR/EGFR tyrosine kinase inhibitor with
RET kinase activity
NSCLC 2Q 2009 2Q 2009
Recentin VEGFR tyrosine kinase inhibitor CRC 2H 2010 2H 2010
Recentin VEGFR tyrosine kinase inhibitor recurrent glioblastoma 2H 2010 2H 2010
ZD4054 endothelin A receptor antagonist hormone resistant prostate cancer 2011 2011
Estimated filing date
Therapy area Compound Mechanism Areas under investigation
MAA NDA
phASE II NCEs
Cardiovascular AZD0837 direct thrombin inhibitor thrombosis 2012 2012
AZD1305 anti-arrhythmic arrhythmias
AZD6370 GK activator diabetes
AZD1656 GK activator diabetes/obesity
Gastrointestinal
AZD3355 inhibitor of transient lower oesophageal
sphincter relaxations (TLESR)
GERD 2011 2011
Infection
CytoFab
™1
anti-TNF-alpha polyclonal antibody severe sepsis
EBV vaccine
1
Epstein-Barr virus vaccine post-transplant proliferative disease
AZD7295 NS 5a inhibitor hepatitis C
Neuroscience
AZD3480
1
neuronal nicotinic receptor agonist Alzheimer’s disease
AZD6765 NMDA receptor antagonist depression 2012 2012
AZD1940 CB1 receptor agonist nociceptive and neuropathic pain
AZD1386 vanilloid receptor antagonist chronic nociceptive pain
AZD2624 NK receptor antagonist schizophrenia
AZD2327 enkephalinergic receptor modulator anxiety and depression
AZD7325 GABA receptor subtype partial agonist anxiety 2013 2012
Oncology
Recentin VEGFR tyrosine kinase inhibitor NSCLC 2013 2013
AZD6244
1
(ARRY-142886) MEK inhibitor solid tumours 2014 2014
AZD2281 PARP inhibitor breast/ovarian cancer 2012 2012
AZD0530 SRC kinase inhibitor solid tumours and haematological malignancies
AZD4877 cell cycle agent haematological malignancies
A ZD1152 aurora kinase inhibitor haematological malignancies 2011 2011
Respiratory &
Inflammation
AZD9056 ion channel blocker (P2X7) rheumatoid arthritis 2012 2012
AZD5672 chemokine receptor antagonist (CCR5) rheumatoid arthritis 2012 2012
AZD1981 CRTh2 receptor antagonist asthma/COPD
MEDI-528 anti-IL-9 antibody asthma
CAT-354 anti-IL-13 antibody asthma
AZD9668 neutrophil elastase inhibitor COPD
AZD1236 matrix metallo-proteinase inhibitor COPD
AZD3199 iLABA asthma/COPD
MEDI-563 anti-IL-5R antibody asthma
MEDI-545 anti-IFN-alpha antibody SLE, myositis
phASE II lINE ExTENSIoNS
Gastrointestinal
Nexium proton pump inhibitor extra-oesophageal reflux disease 3Q 2009
2
3Q 2009
2
Infection
Motavizumab humanised MAb binding to RSV F protein early and late treatment of RSV in paeds >1 yr
1
Partnered product.
2
Publication only.
24
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
Therapy area Compound Areas under investigation
dISCoNTINuEd NCEs
Cardiovascular A ZD1175 diabetes/obesity
AZD2207 diabetes/obesity
Infection AZD2836 hepatitis C
Neuroscience
AZD3480 cognitive disorders in schizophrenia
AZD0328 Alzheimer’s disease
AZD1704 analgesia
Oncology
MEDI-561 (IPI-504) GIST
MEDI-561 (IPI-504) solid tumours
IPI-493 solid tumours
AZD4877 solid tumours
A ZD1152 solid tumours
Respiratory &
Inflammation
AZD4818 COPD
Therapy area Compound Areas under investigation
dISCoNTINuEd lINE ExTENSIoNS
Cardiovascular
Crestor outcomes end
stage renal disease
5
renal disease
CommENTS
As disclosure of compound information is balanced by the business need to maintain
confidentiality, information in relation to some compounds listed here has not been
disclosed at this time.
Compounds in development are displayed by phase.
1
Publication only.
2
Partnered product.
3
US approval based on 12 years and above.
4
Subject to review under the Hart-Scott-Rodino Act.
5
Will proceed to publication.
Estimated filing date
Therapy area Compound Mechanism Areas under investigation
MAA NDA
phASE III lINE ExTENSIoNS
Cardiovascular Atacand angiotensin II antagonist diabetic retinopathy Published
1
Published
1
Atacand Plus angiotensin II antagonist/thiazide diuretic 32/12.5mg, 32/25mg for hypertension Filed
Crestor statin outcomes in subjects with elevated CRP 2Q 2009 2Q 2009
Onglyza
/Metformin FDC
2
DPP-4 inhibitor + biguanide FDC diabetes 2H 2010 4Q 2009
Dapagliflozin/Metformin FDC
2
SGLT2 inhibitor + biguanide FDC diabetes 2011 2011
Gastrointestinal
Nexium proton pump inhibitor peptic ulcer bleeding Filed Filed
Nexium Low Dose
Aspirin
Combination
proton pump inhibitor low dose Aspirin
associated peptic ulcer 3Q 2009 2Q 2009
Nexium proton pump inhibitor extra-oesophageal reflux disease 3Q 2009
1
3Q 2009
1
Infection FluMist live, attenuated, intranasal influenza virus vaccine influenza Filed Launched
Neuroscience
Seroquel D
2
/5HT
2
antagonist bipolar maintenance Filed Launched
Seroquel D
2
/5HT
2
antagonist bipolar depression Approved Launched
Seroquel XR D
2
/5HT
2
antagonist major depressive disorder Filed Filed
Seroquel XR D
2
/5HT
2
antagonist bipolar mania Approved Approved
Seroquel XR D
2
/5HT
2
antagonist bipolar depression Approved Approved
Seroquel XR D
2
/5HT
2
antagonist generalised anxiety disorder Filed Filed
Oncology
Iressa EGFR tyrosine kinase inhibitor NSCLC Filed
Zactima VEGFR/EGFR tyrosine kinase inhibitor
with RET kinase activity
medullary thyroid cancer 2H 2010 4Q 2009
Faslodex oestrogen receptor antagonist rst line advanced breast cancer
Faslodex oestrogen receptor antagonist adjuvant
Respiratory &
Inflammation
Symbicort pMDI inhaled steroid/fast onset, long-acting ß
2
agonist asthma Filed Launched
3
Symbicort pMDI inhaled steroid/fast onset, long-acting ß
2
agonist COPD Filed Filed
Unit Dose Budesonide
2,4
inhaled steroid asthma
DIREcTORs’ REPORT
25
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
SAlES ANd mARKETINg
1
Active in over 100 countries, we have an
extensive sales and marketing network
focused on growing our business and driving
the levels of commercial excellence that will
maintain our position among the industry
world leaders.
Our Global Marketing (GM) function is
responsible for developing and leading our
global brand strategy, to ensure strong
customer focus and commercial direction in
the management of our R&D and brand
development activity, across the full range of
pipeline and marketed products.
We define at an early stage of the drug
discovery process what we believe the profile
of a medicine needs to be to work most
effectively in combating a particular disease.
These disease target product profiles (TPPs)
are based on the insights that GM gains
through its relationships with healthcare
professionals, patients and others for whom
the medicine must add value, including
regulators and payers. The attitudes and
needs of these groups are key drivers of the
development of the TPPs which are used
throughout the life-cycle of a medicine to
guide our R&D activity and help shape the
therapy area and marketing strategies. Early
in the development of new products, we also
consider how best to demonstrate the value
of our medicines to payers.
IN ThE mARKETplACE
As well as building on our leading positions in
Established Markets such as the US, Japan
and Europe, we continue to increase our
strength through strategic investment in
Emerging Markets, where ongoing GDP growth
and changing disease demographics present
significant opportunities for our business.
In these markets, we are applying the same
strategic approach that has delivered our
continued success in Established Markets –
a focus on adapting to local customer needs,
backed by global capability and scale.
As part of this, we are strengthening our
in-country sales and marketing presence to
support swift and effective response to local
customer needs. We continue to deliver
strong, profitable growth in our Emerging
Markets business, alongside our ongoing
investment in these countries.
SAlES FoRCE EFFECTIVENESS
In the majority of key markets, we sell through
wholly-owned local marketing companies.
Elsewhere, we sell through distributors or
local representative offices. Our products are
marketed primarily to physicians (both primary
care and specialist) as well as to other
healthcare professionals. Marketing efforts
are also directed towards explaining the
economic as well as the therapeutic benefits
of our products to governments and others
who pay for healthcare.
Face-to-face contact is still the single most
effective marketing method, but increasingly
the efforts of our sales forces are being
complemented by our use of the internet
to facilitate and enhance our commercial
activities. For a few products we also use
direct-to-consumer advertising campaigns
in the US, where it is an approved and
accepted practice.
The way in which biologics are marketed and
sold is an intensive, personal approach that
is more targeted compared with traditional
pharmaceuticals, with extensive use of
specialty pharmaceutical distributors and
little direct-to-consumer advertising.
We continue to evolve our sales and marketing
model to ensure we stay at the forefront of
best practice in meeting customer needs.
In 2008, we created a cross-commercial
strategy team, charged with the development
and sharing of new sales and marketing best
practice across our marketing companies.
Pilot programmes currently being implemented
include interactive selling models that are
better suited to the time pressures of our
customers, and novel approaches to the use
of web-based tools that provide customers
with information and support for their patients.
In Europe, we have continued to invest
significantly in strengthening the skills of our
commercial teams. Throughout 2008, several
major international training programmes were
held to enhance customer interaction skills and
build capabilities in collecting and analysing
rst-hand customer insight. These programmes
are being reinforced by in-market follow-up
activities to consolidate core segmentation
and management skills, and promote high
quality customer service.
Our rapid growth in Emerging Markets
is driving demand for central commercial
support, particularly in respect of sales force
effectiveness. Core sales and marketing
training programmes have been adapted for,
and deployed in, local environments. The main
focus of these programmes is to embed core
commercial skills, such as segmentation and
targeting, and to strengthen sales managers’
coaching and planning skills. Both regional and
local senior teams have adopted the same
practice of active follow-up and monitoring
as applied in our Established Markets.
AdApTINg To ThE ChANgINg ENVIRoNmENT
We continue to adapt to the changing
demands and market conditions. Restructuring
of our Established Market sales forces is
being made to deliver efficiencies within a
challenging business environment alongside
the expansion of our Emerging Market teams
to ensure we are appropriately resourced
to deliver the full potential of the business
opportunities in these countries.
Our business in Europe is now delivering
improved productivity following our re-
structuring programme which over the last
two years significantly reduced sales force
numbers and marketing spend across all our
major marketing companies in the region.
Productivity benefits are also being seen in
Japan, where we continue to reshape our
sales and marketing cost base to support
existing well performing brands and prepare
for potential launches of new products.
In key Emerging Markets, in line with our
future growth ambitions, we increased our
sales and marketing spending by double-
digit growth rates in 2008 and we continue
to expand our sales forces to support our
strategic expansion in these areas.
SAlES ANd mARKETINg EThICS
Our global reach, coupled with the broad
range of different channels that we use for
interacting with our customers, means that
we face an increasing level of complexity
in the various regulatory and legislative
environments in which we operate.
We are committed to ensuring that we
manage these complexities consistently
and appropriately and deliver ethical sales
and marketing practices worldwide that, as a
minimum, meet or exceed the standards set
by external regulations and codes of practice.
To that end, we require all our marketing
companies to have codes of practice in place
that are in line with our own Code of Conduct
and Global Policies, and which are at least as
restrictive as all applicable external codes.
1
For the AstraZeneca definition of markets
please see the Glossary on page 199.
26
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
our patents in the courts. We can face
challenges early in the patent process and
throughout the life of the patent, until the
patent expires some 20 to 25 years later
(patent expiry is typically ten to 15 years after
the first marketing approval is granted).
These challenges can be to the validity of
a patent and/or to the effective scope of a
patent and are based on ever-evolving legal
precedents. There can be no guarantee of
success for either party in patent proceedings
taking place in patent offices or the courts.
Worldwide experience of biotechnology
patent procurement and enforcement is, like
the technology itself, relatively young and still
developing. As a result, there can be some
uncertainty about the validity and effective
scope of biotechnology patent claims in
the biotechnology arena. The investment
in bringing biotechnology innovations to
the market is huge and a well-functioning,
predictable patent system is vital.
The generic industry is increasingly challenging
innovators’ patents, and almost all leading
pharmaceutical products in the US have
faced or are facing patent challenges from
generic manufacturers. The research-based
industry is also experiencing increased
challenges elsewhere in the world, for
example in Europe, Canada, Asia and Latin
America. We are confident of the value of our
innovations and, through close collaboration
between our intellectual property experts and
R&D scientists, we will continue to seek to
obtain patents and defend them vigorously, if
challenged. Further information about the risk
of the early loss and expiry of patents is
contained in the Risk section from page 74.
Compulsory licensing (the over-ruling of
patent rights to allow patented medicines
to be manufactured by other parties) is
increasingly being included in the access to
medicines debate. AstraZeneca recognises
the right of developing countries to use the
flexibilities in the World Trade Organization’s
TRIPS (Trade-Related Aspects of Intellectual
Property Rights) Agreement (including the Doha
amendment) in certain limited circumstances,
such as a public health emergency. We believe
that this should apply only when all other
ways of meeting the emergency needs have
been considered and where healthcare
frameworks and safeguards to prevent
diversion are in place to ensure that the
medicines reach those who need them.
We take all breaches very seriously and
take appropriate action to prevent repeat
occurrences. This may include re-training,
discipline, or other corrective action up to
and including dismissal, depending on
the circumstances.
Further information about our commitment to
responsible business practice is available on
our website, astrazeneca.com/responsibility.
INTEllECTuAl pRopERTY
Patents are important incentives for the
continued innovation that drives society’s
progress. We continue to commit significant
resources to establishing effective patent
protection for our intellectual property, and
to vigorously defending our patents if they
are challenged.
The discovery and development of a new
medicine requires a significant investment of
time, resource and money by research-based
pharmaceutical companies over a period of
10 or more years. For this to be a viable
investment, the results – new medicines
– must be safeguarded from copying with
a reasonable amount of certainty for a
reasonable period of time. The principal
safeguard in our industry is a well-functioning
patent system that recognises our effort and
rewards our innovation with appropriate
protection allowing time to generate the
revenue we need to re-invest in new
pharmaceutical innovation.
Our first level of protection is typically the
patent to the new molecular entity, either
a new chemical entity or a biological product.
However, further innovations such as new
medical uses or different ways of taking the
treatment are often made during the R&D
process and beyond. Each of these
developments also requires significant
resource investment to obtain marketing
approval from regulatory authorities around
the world. Our policy is to protect all the
innovations that result from the investment
we make in leading-edge science to deliver
new and improved medicines.
We apply for patent protection relatively early
in the R&D process to safeguard our increasing
investment. We pursue these patents as
appropriate through patent offices around
the world, responding to questions and
challenges from patent office examiners.
In some countries, our competitors can
challenge our patents in the patent offices,
and in all countries competitors can challenge
During 2008, we updated and further
strengthened our existing codes of sales
and marketing practice, with a particular
focus on interactions with patient groups,
the use of the internet for communicating
about our products, and anti-bribery and
anti-corruption governance. This update
was supported by extensive training of all
relevant staff in all countries.
Line managers monitor compliance locally
within their teams, supported by dedicated
compliance professionals, who also work to
ensure that appropriate training in sales and
marketing practices is provided. We also have
a nominated signatory network that focuses
specifically on approving promotional materials,
to ensure that they meet all applicable
internal and external code requirements.
At a global level, our Group Internal Audit
teams conduct local audits within our
marketing companies and regional offices.
Marketing companies outside North America
conduct their own local audits under the
control of the Local Compliance Officer,
reporting to the Regional Compliance Officer.
Information concerning instances where our
practices may not be up to the standards
we require is collected through our various
compliance and continuous assurance
reporting routes and reviewed by senior
management in local and/or regional
compliance committees. As appropriate,
serious breaches are reviewed by the
AstraZeneca Board and the AstraZeneca
Audit Committee. More information about
our compliance and assurance processes
is contained in the Risk Management and
Assurance Processes section on page 74.
The variations between national external
frameworks for regulation of sales and
marketing practices create a challenge in
interpreting the number of cases of confirmed
breaches of codes or regulations ruled by
external bodies (our key performance
indicator (KPI)). Nevertheless, this KPI provides
a benchmark against which to measure our
performance over time.
In 2008, we identified a total of 15 such cases
(32 in 2007), based on information gathered
from 63 countries in which we have marketing
subsidiaries or branch offices. We believe this
significant decrease reflects our continuing
commitment in this area and arises primarily
from our strengthened internal procedures.
The decrease should also be seen in the
context of the continuing rise in strict standards
from national and international codes.
DIREcTORs’ REPORT
27
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
Some 600 people are employed at our five
principal biologics commercial manufacturing
and distribution facilities in the US (Frederick,
Maryland; Philadelphia, Pennsylvania and
Louisville, Kentucky); the UK (Speke); and
The Netherlands (Nijmegen) with capabilities
in process development, manufacturing and
distribution of biologics, including worldwide
supply of monoclonal antibodies and influenza
vaccines. In addition to our own capabilities,
Boehringer Ingelheim in Biberach, Germany
serves as our manufacturing partner for
certain monoclonal antibodies. Our biologics
production capabilities are scalable, which
enables efficient management of our
combined small and large molecule pipeline.
Substantially all of our properties are held
freehold, free of material encumbrances
and we believe such properties are fit for
their purposes.
As part of our overall risk management, we
carefully consider the timing of investment to
ensure that secure supply chains are in place
for our products. We have a programme in
place to provide appropriate supply capabilities
for our new products, including an assessment
of new technology needs.
ENSuRINg pRoduCT QuAlITY
We are committed to delivering assured
product quality that underpins both the safety
and efficacy of our medicines.
The manufacturing processes for chemical
products and biologics can be very complex
and must be conducted under rigorous
standards of quality. Manufacturing plants
and processes are subject to periodic
inspections by regulators to ensure that
manufacturers are complying with prescribed
standards of operation. Regulators have
the power to require, if they believe action is
warranted, changes and improvements, to
halt production and impose conditions that
must be satisfied before production can
resume. Regulatory standards also evolve
over time as the industry develops new
manufacturing techniques, so a process that
may have been acceptable at one time may
subsequently require changes.
The outcomes of our own routine internal
inspections, as well as those conducted by
regulatory authorities, are rigorously reviewed
and, if required, actions are taken to improve
quality and compliance consistently across
the organisation. The results of all external
inspections carried out during 2008 were
generally satisfactory. All regulatory compliance
observations that were raised during
Our drive for efficiency and effectiveness
resulted in announcements in 2008 of
planned workforce reductions in our Supply
organisation, which includes the closure of
three sites, Porriño in Spain, Destelbergen in
Belgium and Umeå in Sweden. Our facilities
in Macclesfield (UK) and Södertälje (Sweden)
will also be affected. Subject to local
consultation, we expect these moves to
result in headcount reductions of approximately
1,400 across the business by 2013. We
recognise the impact that significant business
change can have on our employees’ morale
and productivity and the increased risk of
industrial action. We aim to manage these
risks by ensuring that throughout the
implementation of these changes we continue
to consult fully with staff representatives and
act in line with local labour laws. Our Human
Resources policies and processes are also
focused on ensuring that the people affected
are treated with respect, sensitivity, fairness
and integrity at all times, and you can read
more about this commitment in the People
section from page 28 onwards.
SupplY CApABIlITY
We have approximately 10,800 people at 26
manufacturing sites in 18 countries working
on the supply of our products.
Our principal small molecule manufacturing
facilities are in the UK (Avlon and
Macclesfield); Sweden (Snäckviken and
Gärtuna, Södertälje); the US (Newark,
Delaware and Westborough, Massachusetts);
Australia (North Ryde, New South Wales);
France (Dunkirk and Reims); Italy (Caponago);
Japan (Maihara); China (Wuxi) and Puerto
Rico (Canovanas). Approximately 1,400
people work in active pharmaceutical
ingredient supply and 8,800 in formulation
and packaging. We operate a small number
of sites for the manufacture of active
ingredients in the UK, Sweden and France,
complemented by efficient use of
outsourcing. Our principal tablet and capsule
formulation sites are in the UK, Sweden,
Puerto Rico, France and the US, and we also
have major formulation sites for the global
supply of parenteral and/or inhalation products
in Sweden, France, Italy and the UK.
Packaging is undertaken in a large number
of locations, both at our own sites and at
contractors’ facilities, which are situated
close to our marketing companies to ensure
rapid and responsive product supply.
SupplY ANd mANuFACTuRINg
Core to our continued business success is our
ability to provide a secure, high quality,
cost-effective supply of our products worldwide.
We continue to drive operational excellence,
make adjustments to our manufacturing base
and make effective use of strategic outsourcing
to maximise the efficiency of our supply chain
whilst maintaining the highest standards of
quality and security of supply at every stage.
Our supply chains are structured to be
flexible and responsive to the changing
needs in our local markets. During 2008 we
maintained our focus on driving continuous
improvement to our supply system, as part
of a wide-ranging cost and efficiency
programme. This has delivered significant
benefits in recent years, including reduced
manufacturing lead times and lower stock
levels, which have been achieved without
compromising high levels of customer service
and quality. Further improvements are
planned using principles that focus on what
adds value for our customers and patients,
whilst also eliminating waste. In line with
our commitment to strategic outsourcing to
maximise supply chain efficiency, we plan
to outsource all of our active pharmaceutical
ingredient (API) manufacturing within five to
10 years.
We continuously review our manufacturing
assets to make sure that they are being used
in the most effective way, whilst preserving the
flexibility we need to respond to fluctuations
in demand. During 2008, we completed the
sale of facilities in Germany and we closed our
packaging site in Canada. Capital expenditure
on supply and manufacturing facilities totalled
approximately $179 million in 2008
(2007: $191 million; 2006: $201 million)
across a range of projects. We also recently
announced the establishment of regional
offices to optimise further our supply chain
activity. This includes sourcing centres in
Shanghai, China and Bangalore, India,
established to identify high quality suppliers
in those regions to support the growing
market demand there. We will also establish
a regional packing strategy, to improve our
ability to respond to customer requirements,
while equipping the business for Emerging
Markets growth.
The introduction of new manufacturing
processes has brought further opportunities to
drive efficiencies across the global supply chain.
28
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
34% CONTINENTAL EUROPE
32% AMERICAS
17% UK
17% ASIA, AFRICA
AND AUSTRALASIA
practice are consistently applied in the most
efficient way. During 2008, we also introduced
an online resource that will, in time, make
L&D tools and programmes available to all
employees, creating a common platform that
increases access to learning and supports
self-development across the organisation.
Implementation of further online L&D
resources will continue during 2009.
Our leadership development frameworks are
focused on six core capabilities which we
believe are essential for strong and effective
leadership: passion for customers; strategic
thinking; acting decisively; driving performance;
working collaboratively; and developing people
and the organisation. These capabilities apply
to all employees and are used in performance
management, talent management, staffing
and selection at all levels.
To ensure we maintain a flow of effective
leaders, we work to identify individuals with
the potential for increasingly more senior and
complex roles. These talent pools provide
succession candidates for a range of
leadership roles across the Company that are
critical to our continued business success.
CommuNICATIoN ANd dIAloguE
We aim to provide an inclusive environment
that encourages open discussion and debate
at all levels across the Company. As well as
line manager briefings and team meetings,
we use a wide range of media to communicate
with our employees around the world.
We also use a global employee survey
(FOCUS) to track employee opinion across a
range of key topic areas. The results, which
are communicated to all employees, provide
valuable insights that inform strategic
planning across the business. To support our
goal of promoting high levels of employee
engagement, in 2008, our SET took the
decision to run FOCUS annually, rather than
every two years.
86% of our employees participated in the
FOCUS 2008 survey – reflecting their
continued confidence in this feedback
mechanism. Results showed that employee
engagement scores were very strong and we
continue to outperform other pharmaceutical
companies in this area. The results also
indicated that people were seeing increased
levels of cooperation between senior leaders,
enabling more effective global and cross-
functional working. The survey also identified
some key areas that continue to require
attention, in particular the need for improved
communication from leaders about
pEoplE
With over 65,000 employees worldwide,
we value the diverse skills and capabilities
that a global workforce brings to our business.
Aligning these skills and capabilities with
strategic and operational needs, improving
leadership capability, optimising performance
and maintaining high levels of employee
engagement are top priorities, alongside the
integration of responsible business thinking
across all our activities.
SETTINg ThE TARgETS
Clear targets and accountabilities are essential
for ensuring that people understand what is
expected of them as we work to deliver our
business strategy. The AstraZeneca Board
and Senior Executive Team are responsible
for setting our high level strategic objectives
and managing performance against these
(see the Chief Executive Officer, Delegation of
Authority and Senior Executive Team section
on page 86). Managers across AstraZeneca
are accountable for working with their teams
to develop individual and team performance
targets that are aligned to our high level
objectives and against which individual
and team contributions are measured
and rewarded.
Our focus on optimising performance is
reinforced by performance-related bonus
and incentive plans. AstraZeneca also
encourages employee share ownership
by offering employees the opportunity to
participate in various employee share plans,
some of which are described in the Directors’
Remuneration Report from page 174 and
also in Note 24 to the Financial Statements
on page 139.
lEARNINg ANd dEVElopmENT
We encourage and support all our people in
achieving their full potential with a range of
high quality learning and development (L&D)
opportunities around the world.
We are also in the process of adopting a new
global approach, backed by the creation of a
new global L&D organisation in 2008, which
aims to ensure that standards of best L&D
inspections at our sites and at our partners’
sites were resolved satisfactorily. Where
appropriate, the experience and knowledge
obtained as a result of these inspections is
shared with other sites across the Group.
In March 2008, AstraZeneca Australia
undertook a voluntary recall of four batches
of Heparinised Saline 50IU/5ml because of
the detection of a contaminant in the heparin
raw material used in the manufacture of
these batches. The heparin raw material was
manufactured by a number of independent
companies in China and sourced by
AstraZeneca from an independent
supplier. We communicated with all relevant
stakeholders at the time of the recall.
No adverse events were reported as a result
of patients taking our heparinised saline
product. As a result of this incident, we have
taken steps to reinforce the security of our
incoming materials supply chain, including
strengthening our audit programme.
We continue to be actively involved through
our membership in industry associations
in influencing new product manufacturing
regulations, both at national and international
levels, primarily in Europe, the US and Japan.
mANAgEmENT oF ouTSouRCINg RISK
Our global procurement policies and
integrated risk management processes are
aimed at ensuring uninterrupted supply of
sufficiently high quality raw materials and
other key supplies, all of which are purchased
from a range of suppliers. We focus on
a range of risks to global supply, such as
disasters that remove supply capability or
the unavailability of key raw materials and
work to ensure that these risks are effectively
mitigated. Contingency plans include the
appropriate use of dual or multiple suppliers
and maintenance of appropriate stock levels.
Although the price of raw materials may
fluctuate from time to time, our global
purchasing policies seek to avoid such
fluctuations becoming material to our business.
Our risk management also includes mitigating
any reputational risk associated with the
use of third parties. As stated in our Code of
Conduct, we are committed to working only
with suppliers that embrace standards of
ethical behaviour that are consistent with our
own. See the Working with Suppliers section
for more on this commitment on page 75.
EmploYEES BY gEogRAphICAl loCATIoN
DIREcTORs’ REPORT
29
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
human resources processes. As an indicator,
21% of the 82 senior managers reporting to
the SET are women. The change from 2007
(26% of 81 senior managers) is not a result
of reduced commitment to diversity, but is a
consequence of our continued re-organisation
of the Company at all levels, which continues
to impact SET reporting lines.
We have made significant investment in
improving our human resources information
technology and are in the process of
implementing a global system that will drive
consistent people management and data
capture worldwide. Launched in the UK,
Sweden and China in 2006, the system is
now in use in 16 countries which means we
have consistent, detailed and integrated
people information available at a global level
covering over 40,000 employees.
SAFETY, hEAlTh ANd WEllBEINg
Providing a safe workplace and promoting
the health and wellbeing of all our people
remains a core priority. A safe, healthy
working environment not only benefits
employees, it supports our business through
improved employee engagement, retention
and productivity.
We are committed to ensuring that safety and
health risks are understood and managed
responsibly. We continue to build on our
traditional safety and health programmes,
which focus on workplace behaviours and
attitudes, whilst developing new approaches
to managing stress and helping employees
understand their personal health risks.
Wellbeing programmes vary according to
health risk profile, function and local culture,
and include general health initiatives aimed at
increasing exercise levels, reducing smoking,
improving nutrition and managing stress.
We also have plans in place to deal with the
potential threat of pandemic flu, including the
provision of anti-virals for employees based in
areas where adequate supplies may not be
available through national treatment regimes.
Our key performance indicator (KPI) for safety,
health and wellbeing combines the frequency
rates for accidents resulting in fatal and
serious injuries and new cases of occupational
illness into one KPI, with an overall target of
a 50% reduction in the combined rates by
2010, compared with a 2001/2002 reference
point. The overall fatal and serious injury
accident rate for AstraZeneca employees
decreased by 14% to 2.28 per million hours
worked in 2008, whilst the occupational
illness rate increased by 5% to 1.04.
To ensure that a consistent approach
continues to be adopted throughout the
programme, specific guidance is provided for
the HR teams and line managers throughout
the organisation. Our challenge is that there
are differences in the legal frameworks and
the customary practice in the different
geographies which are most affected by the
business changes, but the global guidance
provided aims to ensure that the same or
similar elements are included in local
implementation, for example, open
communication and consultation with
employees, re-deployment support and
appropriate financial arrangements. In line
with our core values, we expect the people
affected to be treated with respect, sensitivity,
fairness and integrity at all times.
Our long-standing arrangements for
interactions with trade unions, elected
employee representatives and worker councils
in the UK and Sweden provide the forum for
productive discussion and collaboration with
regard to our workforce reduction activity.
Elsewhere, our processes follow the nationally
determined arrangements.
humAN RIghTS
We are fully supportive of the principles set
out in the UN Declaration of Human Rights,
and our Code of Conduct and supporting
policies outline the high standards of
employment practice with which everyone in
AstraZeneca is expected to comply, both in
spirit and letter. This includes, as a minimum,
compliance with national legal requirements
regarding wages and working hours.
We also support the International Labour
Organisation’s standards regarding child
labour and minimum working age.
We believe that every employee should be
treated with the same respect and dignity.
All judgements about people for the
purposes of recruitment, hiring, compensation,
development and promotion are made solely
on the basis of a person’s ability, experience,
behaviour, work performance and
demonstrated potential. As part of this,
we are committed to complying with the
provisions of all equality legislation including
the UK Disability Discrimination Act 1995.
We continue to work to ensure that diversity
is appropriately supported in our workforce,
reflected in our leadership and integrated into
business and people strategies. Diversity is
included in our Talent Management SET
objectives and we have a set of minimum
standards that support global alignment in
the integration of diversity and inclusion into our
AstraZeneca’s strategic direction and the
need to strengthen further our change
management capabilities whilst continuing
to invest in the development of our people.
Our leaders take this feedback very seriously.
New targets that address these issues
have been included in the SET business
performance management framework for
2009, and are focused on maintaining the
already high levels of employee engagement,
and improvements to the clarity of direction
by senior leaders.
Our goal of creating a culture of open
discussion and debate is supported by our
well-developed arrangements for interactions
with trade unions, elected employee
representatives and local worker councils.
A challenge for us is ensuring a level of global
consistency whilst allowing enough flexibility
to support the local markets in building good
relations with their workforces that take
account of local laws and circumstances –
which vary from country to country. To that
end, relations with trade unions are nationally
determined and managed locally in line with
the applicable legal framework and standards
of good practice. We provide training at
a local level for managers in consultation
requirements as well as relevant labour law,
and we have a range of Human Resources
(HR) and line manager networks for sharing
experience and good practice, and promoting
alignment across the organisation. At a global
level, we have a Group Employee Relations
Director who supports national managers
in ensuring that their local activities are
consistent with our high level principles.
As we continue to develop our global
platform for managing HR going forward,
we are working to ensure that the strength
of our local management approaches is not
undermined. This is particularly critical to the
effective management of the impact of our
current business changes.
Our continuing strategic drive to improve
efficiency and effectiveness resulted in further
planned reductions of the workforce in some
areas of our business during 2008. New
business reshaping activities, combined
with revised estimates for the original 2007
programme (7,600 job reductions), will result
in the overall programme delivering a reduction
of approximately 15,000 positions by 2013.
All reductions in positions are subject to
consultations with works councils, trade
unions and other employee representatives
and in accordance with local labour laws.
30
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
In the US, where we have a sales force of
around 6,500 people, our “Road Scholars”
driver safety programme has been in place
since 2005 and continues to be a valuable
channel for building awareness and improving
driver skills. During 2008, we further
strengthened commitment and accountability
in this area with the inclusion of a driver
safety objective in the US performance
management framework.
Outside the US, in our International Sales and
Marketing Organisation (ISMO), where we
have around 17,000 representatives across
61 countries, we are implementing a new
driver safety programme, “DriveSuccess”.
Whilst taking account of the different driving
environments across the various ISMO
countries, “DriveSuccess” provides a high-level
framework of common standards to be
adopted by each country. The framework was
rolled out across Europe, Central Eastern
Europe, Middle East and Africa and Latin
America during the last quarter of 2008,
and Asia Pacific, including Japan, will follow
in 2009.
This equates to a combined reduction of 9%
compared to 2007, and we are on track to
achieve the targeted reduction by 2010.
We regret that during 2008 there were six
fatal accidents, resulting in the deaths of
three employees, two sub-contractors and
five members of the public. Five of these
accidents were vehicle related. Three people
were killed in a single vehicle accident in
China, two in a single vehicle accident in
Saudi Arabia and one person killed in vehicle
accidents in the US, Thailand and Egypt.
The sixth accident occurred at one of our
US sites where two sub-contractors were
killed whilst engaged in construction work.
Full investigations into the circumstances
surrounding these accidents are being
carried out.
We work hard to identify the root causes
of any serious accident and use a range
of investigation procedures to help us
avoid repetition. Learning is shared with
management and staff, and our conclusions
about underlying causes are used to improve
our management systems.
With the support of the Executive Vice-
President of Operations, a global initiative
to share learning from recent accidents and
fatalities was implemented during 2008.
A learning package was rolled out to
employees in Operations and relevant areas
of R&D, which focused on involving them in
discussions about the root causes of these
incidents, and on emphasising the need
for everyone to challenge unsafe acts or
working conditions.
We remain dissatisfied with our driver safety
record and we are determined to improve
our performance in this area. Our commitment
centres on the promotion of driver safety
across our sales forces worldwide, taking into
account local conditions and opportunities
for improvement.
DIREcTORs’ REPORT
31
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
The purpose of this Financial Review is to
provide a balanced and comprehensive
analysis of the financial performance of the
business during 2008, the financial position
as at the end of the year and the main
business factors and trends which could
affect the future financial performance of
the business.
All growth rates in this section are expressed
at constant exchange rates (CER) unless
noted otherwise.
CoNTENTS
Measuring performance 31
Business background and
major events affecting 2008 32
Results of operations – summary analysis
of year to 31 December 2008 33
Financial position, including cash
flow and liquidity – 2008 34
Restructuring and synergy costs 36
Capitalisation and shareholder return 37
Future prospects 37
Results of operations – summary analysis
of year to 31 December 2007 38
Financial position, including cash flow
and liquidity – 2007 40
Financial risk management 41
Critical accounting policies and estimates 43
Other accounting information 47
mEASuRINg pERFoRmANCE
The following measures are referred to when
reporting on our performance both in absolute
terms but more often in comparison to earlier
years in this section of the Directors’ Report:
Reported performance. Reported >
performance takes into account all the
factors (including those which we cannot
influence, principally currency exchange
rates) that have affected the results of
our business as reflected in our Financial
Statements prepared in accordance with
International Financial Reporting Standards
(IFRSs) as adopted by the European Union
(EU) and as issued by the International
Accounting Standards Board.
Core financial measure. This is a non- >
GAAP measure because unlike reported
performance it cannot be derived directly
from the information in the Group’s
Financial Statements. This measure is
adjusted to exclude certain significant
items, such as charges and provisions
related to restructuring and synergy
programmes, amortisation and the
impairment of the significant intangibles
arising from corporate acquisitions and
those related to our current and future
exit arrangements with Merck in the
US, and other specified items. See
page 34 for a reconciliaton of Core to
reported performance.
Constant exchange rate (CER) growth >
rates. CER is also a non-GAAP measure.
This measure removes the effects of
currency movements (by retranslating the
current year’s performance at previous
year’s exchange rates and adjusting
for other exchange effects, including
hedging). A reconciliation to reported
performance is provided on page 33.
Gross margin and operating profit >
margin percentages, which set out the
progression of key performance margins
and demonstrate the overall quality of
the business.
Prescription volumes and trends for key >
products, which can represent the real
business growth and the progress of
individual products better and more
immediately than invoiced sales.
Net debt, representing our interest bearing >
loans and borrowings less cash and cash
equivalents and current investments.
We believe that Core financial and growth
measures allow us to analyse more
transparently the progress of our business.
Our recent reported results have been
impacted by the global restructuring and
synergy programmes together with impacts
arising from corporate acquisitions.
FINANcIAL REVIEW
“In 2008, sales increased by 3%, with
sales growth driven by our key brands,
the addition of MedImmune and the
strong performance of Emerging Markets
businesses which grew at 16%. Core
operating margin increased by
1.6 percentage points in constant
currency terms, as a result of improved
efficiencies throughout the organisation
and delivery of our restructuring initiatives.
The improved Core operating margin
translated 3% sales growth for the year
into a 9% increase in Core operating
profit and an 8% increase in Core earnings
per share to $5.10.
Cash generation was strong in 2008; cash
from operating activities increased by over
$1.2 billion, driven principally by an increase
in earnings before interest, tax, depreciation
and amortisation (EBITDA) and reduced
working capital outflows. This enabled us
to make the payment to Merck as part of
the planned phased exit arrangements,
invest in capital and intangible assets
to drive future business growth and
productivity and fund a 10% increase in
the full year dividend, whilst at the same
time reducing our net debt by more than
$1.9 billion to $7.2 billion at the end of 2008.
This strong performance puts us well ahead
of our plan to reduce net debt to $7 billion
by the end of 2010.
We recently announced an expanded
scope for our restructuring programme
to drive further improvements in our
long-term competitiveness. Overall,
the programme is now anticipated to
deliver $2.1 billion in annual savings by
the end of 2010 (up from $1.4 billion),
reaching $2.5 billion per annum by 2013.
The restructuring costs to deliver these
benefits are now expected to be
$2.9 billion (up from $2 billion).
Our continued efforts to drive efficiencies
throughout the business, combined
with a strong focus on converting
growth in EBITDA into cash, should
ensure resilient financial performance
as we face an increasingly challenging
external environment.”
SImoN loWTh
Chief Financial Officer
32
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
Strong performance in Emerging >
Markets with CER sales growth
of 16% (20% reported).
Continued strong performance from >
our five key products (Arimidex, Crestor,
Nexium, Seroquel and Symbicort) with
sales of $17,110 million, up 9% at CER
on prior year sales (12% reported).
Operating profit increased by 4% at CER >
(13% reported). Core operating profit
increased by 9% at CER.
Earnings per share: $4.20, an increase of >
2% at CER (12% reported). Core earnings
per share were $5.10, an increase of 8%
at CER.
Net cash inflow from operating >
activities increased to $8,742 million
(2007: $7,510 million).
The partial retirement of Merck’s interests >
in certain AstraZeneca products in the US
took place on 17 March 2008 through
a $2.6 billion net payment to Merck.
Cash distributions to shareholders >
were $3,349 million (2007: $6,811 million)
through dividend payments of $2,739
million (2007: $2,641 million) and share
re-purchases of $610 million
(2007: $4,170 million).
Net debt decreased to $7,174 million >
(2007: $9,112 million), a reduction of
$1,938 million.
Total restructuring and synergy costs >
associated with the global programme
to reshape the cost base of the business,
were $881 million in 2008 (2007:
$966 million). This brings the total costs
incurred to date to $1,847 million.
The adverse impact on pharmaceutical >
prices as a result of the regulatory
environment. For instance, although
there is no direct governmental control
on prices in the US, action from individual
state programmes and health insurance
bodies are leading to downward pressures
on realised prices. In other parts of the
world, there are a variety of price and
volume control mechanisms and
retrospective rebates based on sales
levels that are imposed by governments.
The risk of generic competition following >
loss of patent exclusivity or patent expiry
or an ‘at risk’ launch by a competitor,
with the potential adverse effects on
sales volumes and prices, for example,
the launch of generic competition to both
Ethyol and Pulmicort Respules in 2008
and Toprol-XL in 2006.
The timings of new product launches, >
which can be influenced by national
regulators and the risk that such new
products do not succeed as anticipated,
together with the rate of sales growth and
costs following new product launches.
Currency fluctuations. Our functional and >
reporting currency is the US dollar, but
we have substantial exposures to other
currencies, in particular the euro, Japanese
yen, sterling and Swedish krona.
Macro factors such as greater demand >
from an ageing population and increasing
requirements of servicing Emerging Markets.
Over the longer term, the success of our R&D
is crucial, and we devote substantial resources
to this area. The benefits of this investment
emerge over the long term and there is
considerable inherent uncertainty as to whether
and when it will generate future products.
The most significant features of our financial
results in 2008 are:
Reported sales of $31,601 million, >
representing CER sales growth of 3%
(7% reported).
Accordingly, in this Financial Review, we show
financial and growth measures adjusted for
the effects of these items. For 2008, we adjust
for the effects of the restructuring and synergy
costs, amortisation and impairment charges
recorded against MedImmune and
amortisation arising on the historic
arrangements with Merck.
CER measures allow us to focus on the
changes in sales and expenses driven by
volume, prices and cost levels relative to
the prior period. Sales and cost growth
expressed in CER allows management to
understand the true local movement in sales
and costs, in order to compare recent trends
and relative return on investment. CER growth
rates can be used to analyse sales in a
number of ways but, most often, we consider
CER growth by products and groups of
products, and by countries and regions. CER
sales growth can be further analysed into the
impact of sales volumes and selling price.
Similarly, CER cost growth helps us to focus
on the real local change in costs so that we
can manage the cost base effectively.
We recognise that CER growth rates and
Core financial measures should not be used
in isolation and, accordingly, we also discuss
comparative reported growth measures that
reflect all the factors that affect our business.
BuSINESS BACKgRouNd ANd
mAJoR EVENTS AFFECTINg 2008
The business background is covered in
the Business Environment section of this
Directors’ Report and describes in detail
the developments in both our products
and geographical regions.
Our operations are focused on prescription
pharmaceuticals, and over 97% of our
sales are made in that sector. Sales of
pharmaceutical products are directly
influenced by medical needs and are generally
paid for by health insurance schemes or
national healthcare budgets. Our operating
results can be affected by a number of
factors other than the delivery of operating
plans and normal competition:
DIREcTORs’ REPORT
33
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
Impairment charges relating to intangible
fixed assets totalled $631 million during the
year. Charges totalling $407 million, including
impairments in respect of Ethyol and HPV
vaccines, have been excluded from Core
operating profit. Charges totalling $224 million,
including $115 million in respect of Pulmicort
Respules, have been included in Core
operating profit. Full details are provided
on page 35.
Core operating profit was up 9% at CER
from 2007 (Reported: up 13%). CER Core
operating margin increased by 1.6 percentage
points to 34.7% of sales as improvements
in gross margin were offset by higher SG&A
costs. Reported operating profits, at 28.9%,
increased by 1.5 percentage points as a result
of improvements in gross margin and R&D
efficiencies which more than offset a modest
increase in SG&A costs.
Net finance expense was $463 million
compared to $111 million for 2007.
points) and intangible asset impairments and
other provisions (0.8 percentage points).
Core R&D costs of $4,953 million were down
1% at CER over last year (Reported: 0%).
The inclusion of a full year of MedImmune
expense was offset by improved productivity
and efficiency, restructuring benefits, portfolio
changes and lower charges relating to
intangible asset impairments charged to
Core R&D expense.
Core SG&A costs of $9,940 million were up
3% at CER (Reported: up 4%) due chiefly
to the inclusion of a full year of MedImmune
costs, increased investment in our Emerging
Markets and some higher legal expenses.
Core other income of $734 million was
$6 million higher than last year (Reported:
decreased $204 million) with MedImmune’s
licensing and royalty income streams offset
by expected lower one-time gains and
royalty income.
RESulTS oF opERATIoNS – SummARY
ANAlYSIS oF YEAR To 31 dECEmBER 2008
The tables on this page and the following
page show our sales analysed by therapy
area, operating profit for 2008 compared
to 2007 and a reconciliation of reported
operating profit to Core operating profit
for 2008 and 2007.
Sales increased by 7% on a reported basis and
by 3% on a CER basis. Currency benefited
reported sales by 4%. More details on our
sales performance by therapy area are given
on pages 53 to 70, in the sections titled
‘Performance 2008’.
Core gross margin of 80.4% in the year was
0.8 percentage points higher than last year
at CER (Reported: 79.1%: 0.8 percentage
points higher). Principal drivers were lower
payments to Merck (1.0 percentage points),
continued efficiency gains and mix factors
(1.2 percentage points), partially offset by
higher royalty payments (0.6 percentage
SAlES BY ThERApY AREA (2008 ANd 2007)
2008 2007 2008 compared to 2007
CER Growth due to CER Reported
Reported growth exchange effect Reported growth growth
$m $m $m $m % %
Cardiovascular 6,963 29 248 6,686 4
Gastrointestinal 6,344 (275) 176 6,443 (4) (2)
Infection and other
1
2,451 706 31 1,714 41 43
Neuroscience 5,837 346 151 5,340 6 9
Oncology 4,954 (109) 244 4,819 (2) 3
Respiratory and Inflammation 4,128 278 139 3,711 7 11
Other businesses 924 54 24 846 6 9
Total 31,601 1,029 1,013 29,559 3 7
1
Includes Synagis and FluMist which were acquired in June 2007.
opERATINg pRoFIT (2008 ANd 2007)
2008 2007 Percentage of sales 2008 compared to 2007
CER Growth due to Reported Reported CER Reported
Reported growth exchange effect Reported 2008 2007 growth growth
$m $m $m $m % % % %
Sales 31,601 1,029 1,013 29,559 3 7
Cost of sales (6,598) 38 (217) (6,419) (20.9) (21.7) (1) 3
Gross profit 25,003 1,067 796 23,140 79.1 78.3 5 8
Distribution costs (291) (39) (4) (248) (0.9) (0.8) 16 17
Research and development (5,179) (88) 71 (5,162) (16.4) (17.5) 2
Selling, general and administrative costs (10,913) (433) (116) (10,364) (34.6) (35.1) 4 5
Other operating income and expense 524 (188) (16) 728 1.7 2.5 (26) (28)
Operating profit 9,144 319 731 8,094 28.9 27.4 4 13
Net finance expense (463) (111)
Profit before tax 8,681 7,983
Taxation (2,551) (2,356)
Profit for the period 6,130 5,627
Earnings per share 4.20 3.74
Growth rates on line items below operating profit, where meaningful, are given elsewhere in this Report.
34
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
FINANCIAl poSITIoN, INCludINg
CASh FloW ANd lIQuIdITY – 2008
All data in this section is on a reported basis
(unless noted otherwise).
Total net assets increased by $1,145 million
to $16,060 million. The increase due to
Group profit of $6,101 million was offset by
dividends of $2,767 million and net share
re-purchases of $451 million. Exchange
movements arising on consolidation and
actuarial losses also reduced net assets
during the year.
The effective tax rate was 29.4% (2007: 29.5%).
Core earnings per share were $5.10, an
increase of 8% at CER on 2007, as
the increase in Core operating profit and
the benefit of a lower number of shares
outstanding was partially offset by increased
net finance expense. Reported earnings per
share increased 12% to $4.20.
gEogRAphICAl ANAlYSIS
We discuss the geographical performances
in the Geographic Review on pages 48 to 52.
The increase in interest expense was driven
by additional borrowings arising as a result
of the acquisition of MedImmune in 2007.
Our exposure to interest costs was reduced
in 2008, from the closing position in 2007, as
we moved debt used to finance the purchase
of MedImmune from short-term, higher interest
rate commercial paper, to longer-term debt
financing at lower interest rates. The 2008
net finance expense benefited from a net
fair value gain of $130 million relating to
two long-term bonds due to widening credit
spreads. We anticipate that the fair value gain
will largely reverse as credit markets stabilise.
RECoNCIlIATIoN oF REpoRTEd RESulTS To CoRE RESulTS
Restructuring
and synergy MedImmune Ethyol and Merck 2008
Reported costs amortisation other impairments
1
amortisation Core
2008 $m $m $m $m $m $m
Gross profit 25,003 405 25,408
Distribution costs (291) (291)
Research and development (5,179) 166 60 (4,953)
Selling, general and administrative costs (10,913) 310 307 257 99 (9,940)
Other operating income and expense 524 120 90 734
Operating profit 9,144 881 427 407 99 10,958
Net finance expense (463) (463)
Profit before tax 8,681 881 427 407 99 10,495
Taxation (2,551) (259) (125) (121) (3,056)
Profit for the period 6,130 622 302 286 99 7,439
Earnings per share 4.20 0.43 0.21 0.19 0.07 5.10
Restructuring
and synergy MedImmune Ethyol and Merck 2007
Reported costs amortisation other impairments amortisation Core
2007 $m $m $m $m $m $m
Gross profit 23,140 415 23,555
Distribution costs (248) (248)
Research and development (5,162) 73 (5,089)
Selling, general and administrative costs (10,364) 478 255 96 (9,535)
Other operating income and expense 728 728
Operating profit 8,094 966 255 96 9,411
Net finance expense (111) (111)
Profit before tax 7,983 966 255 96 9,300
Taxation (2,356) (285) (75) (2,716)
Profit for the period 5,627 681 180 96 6,584
Earnings per share 3.74 0.46 0.12 0.06 4.38
2008 2007 2008 compared to 2007
CER Growth due to CER Total core
Core growth exchange effect Core growth growth
2007 to 2008 $m $m $m $m % %
Gross profit 25,408 1,057 796 23,555 5 8
Distribution costs (291) (39) (4) (248) 16 17
Research and development (4,953) 71 65 (5,089) (1) (3)
Selling, general and administrative costs (9,940) (289) (116) (9,535) 3 4
Other operating income and expense 734 23 (17) 728 3 1
Operating profit 10,958 823 724 9,411 9 16
Net finance expense (463) (111)
Profit before tax 10,495 9,300
Taxation (3,056) (2,716)
Profit for the period 7,439 6,584
Earnings per share 5.10 4.38
1
Includes $150 million of impairments against intangible assets, acquired with MedImmune, relating to the return of rights to the heat shock protein 90 (Hsp90) drug
candidates IPI-504 (MEDI-561) and the IPI-493 to Infinity Pharmaceuticals and revised forecasts for future royalties related to HPV vaccines. Also included is a
$257 million impairment charge for Ethyol following the ‘at risk’ launch of a generic competitor.
DIREcTORs’ REPORT
35
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
in three countries. The following table shows
the dollar effect of a 1% change in the discount
rate on the obligations in those countries.
-1% +1%
UK ($m) 739 (640)
US ($m) 226 (199)
Sweden ($m) 333 (263)
CommITmENTS ANd CoNTINgENT lIABIlITIES
Contingent liabilities principally relate to
litigation including litigation relating to
employment, product liability, commercial
disputes, infringement of intellectual property
rights, the validity of certain patents, anti-trust,
securities laws and governmental investigations.
Most of the claims involve highly complex
issues. Often, these issues are subject to
substantial uncertainties and therefore the
probability of a loss, if any, being sustained
and an estimate of the amount of any loss
are difficult to ascertain. Consequently, for a
majority of these claims, it is not possible to
make a reasonable estimate of the expected
financial effect, if any, that will result from
ultimate resolution of the proceedings. In these
cases, AstraZeneca discloses information with
respect to the nature and facts of the case.
Although there can be no assurance
regarding the outcome of any of the legal
proceedings, based on management’s current
and considered view of each situation, we do
not currently expect them to have a materially
adverse effect on our financial position. This
position could of course change over time.
Assessments as to whether or not to recognise
provisions or assets and of the amounts
concerned usually involve a series of complex
judgements about future events and can rely
heavily on estimates and assumptions.
AstraZeneca believes that the provisions
recorded are adequate based on currently
available information and that the insurance
recoveries recorded will be received.
However, given the inherent uncertainties
involved in assessing the outcomes of these
cases and in estimating the amount of the
potential losses and the associated insurance
recoveries, we could in future periods incur
judgements or insurance settlements that
could have a material adverse effect on our
results in any particular period.
Details of the more significant matters are set
out in Note 25 to the Financial Statements.
into the US market. The settlement of the
Pulmicort Respules patent litigation triggered
an impairment of $115 million. The remaining
impairments arise as a result of the termination
of projects in development and a charge for
$91 million relating to the reassessment of the
licensing income expected to be generated
by the HPV cervical cancer vaccine.
Reported performance includes impairments
in respect of Ethyol, HPV and other projects in
development (principally the return of rights to
Infinity Pharmaceuticals) which management
believe are not part of Core performance.
As a result, management has adjusted for
impairments totalling $407 million in
presenting Core performance.
INVENToRIES
Inventories have decreased by $483 million
to $1,636 million due to exchange movements
of $298 million along with an underlying
reduction in inventory of $185 million.
RECEIVABlES, pAYABlES ANd pRoVISIoNS
Trade and other receivables increased by
$593 million to $7,261 million. Exchange
rate movements reduced receivables by
$429 million. The underlying increase of
$1,022 million was driven by increased sales
in our Emerging Markets, the extension of
major credit terms in the UK and increased
insurance recoverables.
Trade and other payables increased by
$130 million, or $675 million after removing
the impacts of exchange rate movements,
primarily due to increases in US managed
market accruals. Trade payables include
$2,136 million in respect of accruals relating
to rebates and reductions in our US market.
These are explained and reconciled fully
on pages 43 and 44.
Provisions increased by $122 million driven
mainly by increases in specific insurance
and long-term provisions.
TAx pAYABlE ANd RECEIVABlE
Net income tax payable has increased by
$667 million to $1,968 million principally due
to tax audit provisions and cash tax timing
differences. Net deferred tax liabilities have
decreased mainly as a result of the impact
of actuarial losses suffered in the year, the
amortisation and impairment of MedImmune
intangibles and exchange benefits.
RETIREmENT BENEFIT oBlIgATIoNS
Net retirement benefit obligations increased by
$734 million principally as a result of actuarial
losses of $1,232 million offset by exchange
benefits of $434 million. Approximately 95%
of the Group’s obligations are concentrated
On 17 March, AstraZeneca paid $2.6 billion
to Merck. This payment resulted in AstraZeneca
acquiring Merck’s interests in certain
AstraZeneca products including Pulmicort,
Rhinocort, Symbicort and Toprol-XL and
has been included in intangible assets as
explained below.
pRopERTY, plANT ANd EQuIpmENT
Property, plant and equipment fell by
$1,255 million to $7,043 million primarily
due to depreciation and impairments of
$1,182 million and exchange movements
of $1,131 million offset by additions of
$1,113 million.
goodWIll ANd INTANgIBlE ASSETS
Goodwill and intangibles have increased
by $846 million to $22,197 million.
The main components within goodwill are
the amounts capitalised on acquisition of
MedImmune of $8,757 million and on the
restructuring of our US joint venture with
Merck in 1998. No significant amounts have
been capitalised within goodwill in 2008.
The total goodwill balance has reduced by
$10 million due to exchange rate movements.
Intangible assets have increased by
$856 million to $12,323 million. Additions
totalled $2,941 million, amortisation was
$807 million and impairments totalled
$631 million. Exchange reduced intangibles
by $603 million.
Additions to intangible assets in 2008 included
a payment made to Merck under pre-existing
arrangements under which Merck’s interests
in our products in the US will be terminated
(subject to the exercise of certain options).
$994 million of this payment relates to certain
specific AstraZeneca products, including
Pulmicort, Rhinocort, Symbicort and
Toprol-XL. As a result of the payment
AstraZeneca no longer has to pay contingent
payments on these products to Merck and
has obtained the ability to fully exploit
these products and to fully exploit other
opportunities in the Respiratory therapy area
that AstraZeneca was previously prevented
from doing by Merck’s interests in these
products. The remainder of the payment
($1,656 million) represents payments
on account for the product rights that will
crystallise if we exercise options in 2010.
Further details of this are included in Note 25
to the Financial Statements.
In March, a $257 million intangible asset
impairment charge was taken as a result
of the entry of generic Ethyol, a product
capitalised on the acquisition of MedImmune,
36
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
When fully implemented, these and other
new business reshaping activities, combined
with revised estimates for the original 2007
programme, will result in the overall programme
delivering a reduction of approximately
15,000 positions by 2013. Reductions in
positions are subject to consultations with
works councils, trade unions and other
employee representatives and in accordance
with local labour laws.
As a result of the expanded scope of these
business reshaping programmes, total
programme charges for restructuring and
synergies are now estimated to reach
$2,950 million. When fully implemented,
programme benefits are now estimated to
reach $2.5 billion per annum.
which we currently anticipate repaying from
current cash balances of $4,286 million
and business cash flows, without the need
to re-finance.
Net debt of $7,174 million has decreased
by $1,938 million from 31 December 2007.
We continue to believe that, although our
future operating cash flows are subject to
a number of uncertainties, as specified in the
Business Background section on page 32, our
cash and funding resources will be sufficient
to meet our forecasting requirements, including
developing and launching new products,
externalisation, our ongoing capital programme,
our restructuring programme, debt servicing
and repayment and shareholder distributions.
RESTRuCTuRINg ANd SYNERgY CoSTS
In 2008 we continued the global restructuring
and synergy programmes announced in 2007.
Costs for the full year totalled $881 million (of
which $219 million are non-cash items).
This annual total reflects an extension in
the scope of the previously announced
$1,975 million programme. New initiatives
include further rationalisation of the global
supply chain, additional restructuring of the
sales and marketing organisation and
business infrastructure.
CASh FloW
Cash generated from operating activities
was $8,742 million in the year, compared
with $7,510 million in 2007. The increase of
$1,232 million was principally driven by an
increase in operating profit before depreciation,
amortisation and impairment costs of
$1,814 million, a decrease in tax payments
of $354 million and lower working capital
outflows of $233 million, offset by an increase
in interest payments of $355 million and a
decrease in non-cash items of $814 million
which includes movements on provisions.
Net cash outflows from investing activities
were $3,896 million in the year compared
with $14,887 million in 2007.
Cash distributions to shareholders were
$3,349 million through dividend payments
of $2,739 million and share re-purchases
of $610 million.
During the year we issued a further €500
million, 5.625% 18-month bond as part of
our re-financing programme, the proceeds of
which have been used to re-finance maturing
commercial paper.
Gross debt (including loans, short-term
borrowings and overdrafts) was $11,848
million as at 31 December 2008 (2007:
$15,156 million). Of this debt, $993 million
is due within one year (2007: $4,280 million)
NET dEBT
2008 2007
$m $m
Cash and short-term investments 6,044 7,76 0
Loans and borrowings (15,156) (1,223)
Net (debt)/funds brought forward at 1 January (9,112) 6,537
Earnings before interest, tax, depreciation, amortisation and impairment 11,764 9,950
Movement in working capital (210) (443)
Tax paid (2,209) (2,563)
Interest paid (690) (335)
Other non-cash movements 87 901
Net cash available from operating activities 8,742 7, 510
Purchase of intangibles (2,944) (549)
Other capital expenditure (net) (1,057) (1,076)
Acquisitions (14,891)
Investments (4,001) (16,516)
Dividends (2,739) (2,641)
Net share re-purchases (451) (3,952)
Distributions (3,190) (6,593)
Other movements 387 (50)
Net debt carried forward at 31 December (7,174) (9,112)
Comprised of:
Cash and short-term investments 4,674 6,044
Loans and borrowings (11,848) (15,156)
DIREcTORs’ REPORT
37
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
FuTuRE pRoSpECTS
The Company has set its financial targets
for 2009 in anticipation of the normal range
of risks and opportunities typical for the
pharmaceutical sector together with the
turmoil in the financial markets and the
broader economy. Management believes
that successful execution of its business
plan, underpinned by the underlying financial
and operating strength of the Company, will
result in achievement of a resilient financial
performance even in this challenging
business climate.
CApITAlISATIoN ANd ShAREholdER RETuRN
All data in this section is on a reported basis.
CApITAlISATIoN
The total number of shares in issue at
31 December 2008 was 1,447 million.
4.1 million shares were issued in consideration
of share option plans and employee share
plans for a total of $159 million. Reserves
were reduced by $2,277 million in 2008 due
to the effect of exchange rates and actuarial
losses. Shareholders equity increased by a net
$1,134 million to $15,912 million at the year
end. Minority interests increased to $148
million (2007: $137 million).
dIVIdENd ANd ShARE RE-puRChASES
In line with the Board’s distribution policy and
its overall financial strategy to strike a balance
between the interests of the business,
shareholders and financial creditors, whilst
maintaining strong investment grade credit
rating, total share re-purchases in 2008
were 13.6 million shares at a total cost of
$610 million. This represented 0.9% of
the share capital at the start of the year.
All shares re-purchased have been cancelled.
This brings the total number of shares
re-purchased to date since the beginning
of the re-purchase schemes in 1999, to
376.3 million shares at a total cost of
$18,099 million. The Board has decided
that no share re-purchases will take place
in 2009 in order to maintain the flexibility
to invest in the business.
In the year, 4.1 million shares were issued in
consideration of share option exercises for
a total of $159 million.
The Board regularly reviews its shareholder
returns strategy, and in 2008 reaffirmed the
dividend policy, which is to grow dividends in
line with reported earnings before restructuring
and synergy costs, with an aim to maintain at
least two times dividend cover.
dIVIdENd FoR 2008
$ Pence SEK Payment date
First interim dividend 0.55 27.8 3.34 15 September 2008
Second interim dividend 1.50 104.8 12.02 16 March 2009
Total 2.05 132.6 15.36
SummARY oF ShAREholdER dISTRIBuTIoNS
Total Total
Shares Dividend dividend shareholder
re-purchased Cost per share cost distributions
(million) $m $ $m $m
1999 4.4 183 0.700 1,242 1,425
2000 9.4 352 0.700 1,236 1,588
2001 23.5 1,080 0.700 1,225 2,305
2002 28.3 1,190 0.700 1,206 2,396
2003 27.2 1,154 0.795 1,350 2,504
2004 50.1 2,212 0.940 1,555 3,767
2005 67.7 3,001 1.300 2,068 5,069
2006 72.2 4,147 1.720 2,649 6,796
2007 79.9 4,170 1.870 2,740 6,910
2008 13.6 610 2.050 2,971
1
3,581
1
Total 376.3 18,099 11.475 18,242 36,341
1
Total dividend cost estimated based upon number of shares in issue at 31 December 2008.
38
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
gEogRAphICAl ANAlYSIS
2007 sales by major region are included in
the performance table on page 49 of the
Geographical Review.
Sales in the US were $13,366 million in 2007
(up 7%). In the US, sales of Nexium, Seroquel,
Crestor and Arimidex were $8,364 million,
almost 63% of total US sales. Symbicort
was launched in the US in the year with
sales of $50 million. Sales in Canada were
$1,145 million for 2007 (up 5%).
Sales in the rest of the world were $15,048
million in 2007 (up 8%). Key products
(Crestor, Symbicort, Seroquel and Arimidex)
were up 20%. Latin America, Middle East
and Africa, and Asia Pacific were up 18%.
Spain and the UK had sales growths of 7%
and 8% respectively. Sales in Germany
continued to be impacted by doctors being
encouraged to prescribe generics in 2006
and were down 3%. Sales growth of 11%
was achieved in Japan in 2007.
costs. Earnings per share for 2007 were
$3.74, a 3% decline from $3.86 in 2006.
pERFoRmANCE – CER gRoWTh RATES
Sales
Sales for 2007 increased 7%. The contribution
to sales growth in 2007 from the acquisition
of MedImmune more than offset the decline
from Toprol-XL in the US. 2007 sales in the
US were up 7%, and this was broadly similar
to sales growth in the market if Toprol-XL and
the impact of MedImmune were excluded.
Sales outside the US were up 8%, comprising
growth of 5% in Established Markets and
17% in the Emerging Markets.
For the second year, our portfolio in 2007
had 11 brands with annual sales greater
than $1 billion. The combined sales of our
key products (Arimidex, Crestor, Nexium,
Seroquel and Symbicort) grew by 11% in
2007 to $15,344 million, and accounted for
about 52% of our turnover.
Details on our 2007 sales performance by
therapy area are given on pages 53 to 70,
in the section for each individual therapy area
titled ‘Performance 2007’.
RESulTS oF opERATIoNS – SummARY
ANAlYSIS oF YEAR To 31 dECEmBER 2007
Core measures, as used in our commentary
above on the financial results for 2008
(including comparison to 2007), are not
referred to in the analysis of operating margin
and profit for 2007 detailed below as this
measure was introduced for 2008. Where
appropriate, when comparing 2007 reported
performance to 2006, the impact of the
acquisition of MedImmune in 2007
is analysed to provide a more appropriate
comparison between the two years.
The tables below show our sales by therapy
area and operating profit for 2007 compared
to 2006.
REpoRTEd pERFoRmANCE
Our 2007 sales increased by 12% from
$26,475 million to $29,559 million, an increase
reflecting both the acquisition of MedImmune
and the entry of generic competition on all
strengths of Toprol-XL in the US, as well as
general business performance. Operating
profit for 2007 fell by 1%, again reflecting
the impacts of MedImmune and Toprol-XL
together with restructuring and synergy
SAlES BY ThERApY AREA (2007 ANd 2006)
2007 2006 2007 compared to 2006
CER Growth due to CER Reported
Reported growth exchange effects Reported growth growth
$m $m $m $m % %
Cardiovascular 6,686 292 276 6,118 5 9
Gastrointestinal 6,443 (379) 191 6,631 (6) (3)
Infection and other 1,714 779 60 875 89 96
Neuroscience 5,340 484 152 4,704 10 14
Oncology 4,819 359 198 4,262 8 13
Respiratory and Inflammation 3,711 369 191 3,151 12 18
Others 846 79 33 734 11 15
Total 29,559 1,983 1,101 26,475 7 12
opERATINg pRoFIT (2007 ANd 2006)
2007 2006 Percentage of sales 2007 compared to 2006
CER Growth due to CER Reported
Reported growth exchange effects Reported 2007 2006 growth growth
$m $m $m $m % % % %
Sales 29,559 1,983 1,101 26,475 7 12
Cost of sales (6,419) (703) (157) (5,559) (21.7) (21.0) 13 15
Gross margin 23,140 1,280 944 20,916 78.3 79.0 6 11
Distribution costs (248) (7) (15) (226) (0.8) (0.9) 3 10
Research and development (5,162) (944) (316) (3,902) (17.5) (14.7) 24 32
Selling, general and administrative costs (10,364) (843) (425) (9,096) (35.1) (34.4) 9 14
Other operating income and expense 728 188 16 524 2.5 2.0 36 39
Operating profit 8,094 (326) 204 8,216 27.4 31.0 (4) (1)
DIREcTORs’ REPORT
39
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
other income of $169 million primarily through
human papilloma virus vaccine royalty income),
other income of $559 million was $35 million
higher than 2006, as expected reductions in
royalty income were more than offset by higher
one-time gains and insurance recoveries.
Total charges of $966 million were taken
in respect of the restructuring and synergy
programmes in 2007, of which $723 million
represent cash costs. Over the same period,
productivity initiative benefits of $250 million
and synergy benefits of $50 million have
been realised.
MedImmune contributed an operating loss
of $178 million (which included amortisation
costs of $255 million) in 2007.
Net finance expense in 2007 was $111 million
in the full year (2006 income: $327 million).
The reduction from 2006 was principally
attributable to the interest payable on the
borrowings to acquire MedImmune, Inc.
Interest expense on the new debt was
$446 million. The 2007 reported amounts
include net income of $34 million (2006:
$43 million) arising from employee benefit
fund assets and liabilities reported under
IAS 19 ‘Employee Benefits’.
The effective tax rate for 2007 was 29.5%,
similar to the 29% for 2006. The slight increase
for 2007 compared to 2006 reflected the
combined effect of differences in the
geographical mix of profits, the reversal
of tax deductions relating to share-based
payments, the reduction in the UK tax rate
as applied to UK net deferred tax liabilities,
and an increase in tax provisions principally
in relation to global transfer pricing.
Reported earnings per share for 2007
were $3.74 compared with $3.86 in 2006,
a decrease of 5%. After adjusting for the
impact of restructuring and synergy costs,
2007 earnings per share rose from $3.86
to $4.20, an increase of 7%. Excluding the
impact of MedImmune as well, earnings per
share increased by 15% to $4.52. The share
re-purchase programme is calculated to
have added 8 cents to EPS during 2007,
after allowing for an estimate of interest
income foregone.
opERATINg mARgIN ANd RETAINEd pRoFIT
Operating profit for 2007 was $8,094 million,
down 4% at CER. Excluding restructuring
and synergy costs of $966 million, 2007
operating profit increased to $9,060 million
(up 8% on 2006 at CER). This operating
profit improvement was net of a reported
$1,187 million increase in R&D investment,
and was fuelled by revenue growth, improved
gross margin and lower expenditures in
SG&A on a constant currency basis.
Restructuring and synergy benefits of
$300 million were realised during 2007.
Reported operating margin was 27.4%.
In 2007 reported gross margin decreased by
0.7 percentage points. After adjusting for the
impact on gross margin of the acquisition of
MedImmune ($472 million) and restructuring
and synergy costs ($415 million), 2007 gross
margin increased by 1.0 percentage points
against 2006 to 80.0%. Principal drivers
included reduced payments to Merck
(0.7 percentage points), asset provisions
booked during the prior period (0.4 percentage
points) and favourable currency movements
(0.2 percentage points). An adverse effect
arose from increased royalty payments, which
led to a 0.4 percentage point reduction.
R&D investment increased by 24% (CER
growth) to $5,162 million in 2007, 17.5%
of sales, an increase of 2.8 percentage
points. After adjusting for the impact of the
acquisition of MedImmune ($255 million) and
restructuring and synergy costs ($73 million),
R&D expenditure was $4,834 million in 2007,
up 16% (CER growth) and 2.1 percentage
points over 2006 due principally to
increased activity levels and the effect of
the externalisation strategy.
Selling, general and administrative costs
in 2007 increased by 9% (CER growth) to
$10,364 million. After adjusting for the impact
of the MedImmune acquisition ($560 million)
and restructuring and synergy costs ($478
million) and currency impacts, SG&A costs
were 2% lower than the same period in 2006,
primarily as a result of operational efficiencies
from our selling and marketing activities.
At $728 million, other operating income and
expense in 2007 was 36% higher than 2006.
After adjusting for the impact of the
MedImmune acquisition (which contributed
40
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
SEpTEmBER 2007
Floating rate 2009 $650m
Fixed 5.4% 2012 $1,750m
Fixed 5.9% 2017 $1,750m
Fixed 6.45% 2037 $2,750m
Fixed 5.125% 2015 750m
NoVEmBER 2007
Fixed 4.625% 2010 €750m
Fixed 5.75% 2031 £350m
$750 million each of the 2012 and 2017 US
dollar fixed rate debt was swapped into
floating rates. As at 31 December 2007,
we also had commercial paper outstanding
amounting to $4,112 million.
TAx pAYABlE ANd RECEIVABlE
Net income tax payables increased in 2007
due to tax audit provisions, less the settlement
of tax on the disposal of the Humira
royalty
stream. Net deferred tax liabilities increased
primarily due to the acquisition of MedImmune
and the recognition of deferred tax liabilities in
respect of intangible assets.
CASh FloW
We continued to be a highly cash-generative
business. However, the cost of acquisition of
MedImmune meant that our funds and debt
profile changed in 2007.
Cash generated from operating activities was
$7,510 million in 2007, only slightly down on
2006 ($7,693 million). The small decrease
in operating profit was compensated for by
an increase in non-cash items ($638 million
principally from unspent restructuring costs)
and depreciation, amortisation and
impairment ($511 million). These compensating
effects were offset by an increase in working
capital requirements of $551 million and
additional tax and interest payments
($394 million and $265 million respectively).
Net cash outflows from investing activities
were $14,887 million in 2007 compared to
$272 million in 2006. Excluding the higher
returns from movements in short term
investments and fixed deposits and net
disposals of non-current asset investments
($1,280 million in 2007 compared to
$1,171 million in 2006), interest received and
dividends paid by subsidiaries, cash outflow
from investing activities was $16,516 million
in 2007, compared to $1,791 million in 2006.
This increase in outflow was due primarily
to the acquisition of MedImmune, Inc.; other
acquisitions included Arrow Therapeutics
Limited, Atlantis Components Inc. and
with Merck and the subsequent merger of
Astra and Zeneca in 1999 ($1,026 million),
the acquisition of Cambridge Antibody
Technology in 2006 ($605 million), launched
and in development product in-licensing
activities ($1,327 million) and software
development costs ($434 million).
INVENToRIES
Inventories have decreased by $131 million
from $2,250 million at the end of 2006 to
$2,119 million. This decrease represents
an underlying improvement of $442 million,
offset by the acquisition of MedImmune and
exchange effects.
RECEIVABlES, pAYABlES ANd pRoVISIoNS
Receivables have risen from $5,561 million
to $6,668 million as at 31 December 2007,
an increase of $1,107 million. Higher sales in
2007, particularly in the US, Europe, China
and from the impact of the MedImmune
acquisition (whose sales are concentrated
in the first and last quarters of the year),
insurance recoveries, acquisition and
exchange effects were the principal drivers,
offset in part by the receipt of the second
instalment in respect of the US anaesthetics
business disposal in 2006.
Current payables also rose from $6,295 million
to $6,968 million at the end of 2007. There
was a small net underlying movement in
trade creditors, other payables and accruals,
with increases in deductions for chargebacks,
rebates and returns in the US being offset
by decreases in trade payables, particularly
to Merck. However, exchange and the
acquisition of MedImmune drove the overall
balance up.
Provisions increased primarily as a result of
the restructuring and synergy programmes
undertaken during 2007, rising from $366
million in 2006 to $1,020 million at the end
of 2007.
dEBT
The acquisition of MedImmune was funded
initially through drawing on a $15 billion 364
day loan facility, which was subsequently
re-financed with short-term US commercial
paper. In the second half of 2007, we
undertook a programme of issuing debt on
the US and European markets, as follows:
FINANCIAl poSITIoN, INCludINg
CASh FloW ANd lIQuIdITY – 2007
All data in this section is on an actual basis
(unless noted otherwise).
The book value of our net assets decreased
by $501 million to $14,915 million at the
2007 year end. Dividends of $2,658 million
and share re-purchases of $4,170 million
exceeded net profit of $5,595 million, whilst
net movements through other recognised
income and expense (principally exchange
and actuarial losses) increased net assets.
The overall shape of the balance sheet was
changed by the acquisition of MedImmune.
pRopERTY, plANT ANd EQuIpmENT
Property, plant and equipment rose from
$7,453 million to $8,298 million at the end
of 2007. The increase was due to continued
investment across the business of $1,169
million, particularly in R&D, the acquisition
of MedImmune ($593 million) and exchange
impacts ($350 million), offset by depreciation
and impairment of $1,182 million and
disposals ($92 million).
goodWIll ANd INTANgIBlE ASSETS
Goodwill and intangibles rose from
$4,204 million at the beginning of 2007
to $21,351 million at 31 December 2007.
The increase is due almost entirely to the
acquisition of MedImmune. The goodwill
arising on the acquisition of MedImmune
amounted to $8,757 million increasing the
balance sheet total to $9,884 million; the
other major component of the carrying value
of goodwill relates to the restructuring in 1998
of our joint venture arrangements with Merck.
Intangibles also increased in 2007, primarily
as a result of the MedImmune acquisition,
supplemented by other company acquisitions
and ongoing in-licensing activities. Intangibles
arising from the MedImmune acquisition
comprised launched products of $7,478
million (principally the respiratory syncytial
virus (RSV) franchise, other products such as
FluMist and Ethyol, together with contractual
and licensing income) and in development
projects amounting to $597 million. In total,
intangibles amount to $11,467 million at the
2007 year end and, in addition to those arising
from the MedImmune acquisition, include
intangibles arising from the restructuring in
1998 of our joint venture arrangements
DIREcTORs’ REPORT
41
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
FINANCIAl RISK mANAgEmENT
FINANCIAl RISK mANAgEmENT polICIES
Insurance
Our risk management processes are described
in the Risk section on pages 74 to 82. These
processes enable us to identify risks that
can be partly or entirely mitigated through
use of insurance. We negotiate best available
premium rates with insurance providers on
the basis of our extensive risk management
procedures. In the current insurance market,
the level of cover is decreasing whilst premium
rates are increasing. Rather than simply paying
higher premiums for lower cover, we focus
our insurance resources on the most critical
areas, or where there is a legal requirement,
and where we can get best value for money.
Risks to which we pay particular attention
include business interruption, Directors’ and
Officers’ liability and property damage.
Taxation
Tax risk management forms an integrated part
of the Group risk management processes.
Our tax strategy is to manage tax risks
and tax costs in a manner consistent with
shareholders’ best long-term interests, taking
into account both economic and reputational
factors. We draw a distinction between
tax planning using artificial structures and
optimising tax treatment of business
transactions, and we only engage in the latter.
Treasury
The principal financial risks to which the Group
is exposed are those of liquidity, interest rate,
foreign currency and credit. The Group has a
centralised treasury function to manage these
risks in accordance with Board-approved
policies. Specifically, liquidity risk is managed
through maintaining access to a number
of sources of funding to meet anticipated
funding requirements, including committed
bank facilities and cash resources. Interest
rate risk is managed through maintaining a
debt portfolio that is weighted towards fixed
rates of interest. Accordingly the Group’s net
interest charge is not significantly affected by
changes in floating rates of interest. We do
not currently hedge the impact on earnings
and cash flow of changes in exchange rates,
with the exception of the currency exposure
that arises between booking and settlement
date on non-local currency purchases and
sales by subsidiaries and the external
dividend, along with certain non-US dollar
debt. Credit risk is managed through setting
and monitoring credit limits appropriate for
the assessed risk of the counterparty.
Verus Pharmaceuticals, Inc. which includes
the North American rights to Captisol
-enabled
budesonide solution and a proprietary
albuterol formulation.
In the area of product acquisitions in 2007,
we capitalised $100 million in respect of the
collaboration disclosed with Bristol-Myers
Squibb (BMS) in respect of saxagliptin and
dapagliflozin. A global licensing and research
collaboration with Palatin Technologies Inc.
to discover, develop and commercialise small
molecule compounds that target melanocortin
receptors for the treatment of obesity and
related indications was entered into, with
a $10 million capitalised upfront payment.
We have also entered a three-year research
and development collaboration with Silence
Therapeutics plc to discover and develop
proprietary siRNA molecules primarily in the
respiratory field but with the option to extend
into other disease areas. The initial access fee
of $5 million was capitalised as an intangible
asset and the $10 million equity investment was
capitalised as a non-current asset investment.
In respect of ongoing collaborations, we have
made further milestone payments of $20 million
in 2007 in relation to the agreement with
Protherics (upon the successful scale-up
of the manufacturing process under the
development and commercialisation
agreement) and $30 million under the
agreement with POZEN (in relation to the
execution of the revised agreement and
recognition of successful proof of concept).
We have also paid $48 million for the last in
a series of sales-based milestone payments
in relation to Zomig.
Astra Tech acquired Atlantis Components,
Inc., with its specialist CAD/CAM technology
used to design and manufacture customised
dental implant abutments, for $71 million and
Denics International Co. Ltd, its Japanese
distributor for $5 million. Intangible assets
of $121 million have been recognised (with
associated deferred tax liability of $48 million).
In October 2007, we decided, by mutual
agreement, to end our collaboration with
NPS Pharmaceuticals, Inc. to discover
and develop drugs targeting metabotropic
glutamate receptors (mGluRs). We have
agreed to pay $30 million to acquire NPS’s
assets relating to the collaboration.
In 2007, our recent focus on in-licensing
opportunities with third parties resulted in
additional intangible assets on the balance
sheet. Should any of these products fail in
development, the associated intangibles
will need to be written off.
Denics International Co. Ltd. Investment in
intangible assets was at broadly similar levels
to 2006, and there were significantly higher
payments for property, plant and equipment
through increased investment in facilities,
particularly in research and development.
Cash returns in 2007 to shareholders were
$6,811 million (through share re-purchases
of $4,170 million and dividend payments of
$2,641 million), compared to $6,367 million
in 2006. After taking into account proceeds
from the issue of share capital of $218 million
(2006: $985 million), net share re-purchases
rose from $3,162 million to $3,952 million
in 2007.
Net funds of $6,537 million at the beginning
of 2007 had become net debt of $9,112
million by the end of 2007.
INVESTmENTS, dIVESTmENTS ANd
CApITAl ExpENdITuRE
The major investment in 2007 was the
acquisition of MedImmune.
On the acquisition of MedImmune, the
purchase price for outstanding shares
of $13.9 billion was allocated between
intangible assets of $8.1 billion (including
assets in respect of Synagis and motavizumab
RSV franchise, FluMist, Ethyol and products
in development), goodwill of $8.8 billion and
net liabilities of $3.0 billion. This allocation,
based on strict accounting requirements,
does not allow for the separate recognition
of valuable elements such as buyer specific
synergies, potential additional indications
for identified products or the premium
attributable to a well established, highly
regarded business in the innovative biologics
market. Such elements are instead subsumed
within goodwill, which is not amortised.
This balance between goodwill and intangible
assets results in an amortisation charge
of approximately $435 million per annum.
Further details of this acquisition are included
in Note 22 to the Financial Statements on
page 130.
The other major company and product
acquisitions in 2007 reflected our
ongoing commitment to strengthening the
product pipeline.
In 2007, we completed the acquisition of
Arrow Therapeutics Limited at a net cost
of $143 million, strengthening our portfolio
of promising anti-infective treatments and
providing a technology platform in an area
of research that complements our capabilities
in anti-bacterials. We paid $34 million to
acquire the paediatric asthma business of
42
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
of the long-term debt entered into in 2007 in
order to finance the acquisition of MedImmune,
has been held at fixed rates of interest. The
Group uses interest rate swaps and forward
rate agreements to manage this mix.
As at 31 December 2008, the Group held
interest rate swaps with a notional value of
$2.5 billion, converting the 5.4% callable bond
maturing in 2014, and the 7% guaranteed
debentures payable in 2023 to floating rates
and partially converting the 5.4% callable
bond maturing in 2012 and the 5.9% callable
bond maturing in 2017 to floating rates.
No new interest rate swaps were entered
into during 2008. The majority of the Group’s
cash balances are held with third party fund
managers with floating rates of interest
being earned.
Sensitivity analysis considering the Group’s
exposure to interest rate movements is
detailed in Note 16 to the Financial Statements
on pages 122 to 126.
Credit exposure
The Group is exposed to credit risk on
financial assets, such as cash balances
(including fixed deposits and cash and cash
equivalents), derivative instruments, trade
and other receivables. The Group is also
exposed in its net asset position to its own
credit risk in respect of the 2023 debentures
and 2014 bonds which are accounted for at
fair value through profit or loss.
During the year, the Company established a
credit risk oversight group, consisting of senior
members of the Finance function to monitor
credit related risks and risk management
processes, in response to the ongoing
financial markets and economic uncertainty.
Trade receivable exposures are managed
locally in the operating units where they arise
and credit limits are set as deemed appropriate
for the customer.
Exposure to financial counterparty credit risk
is controlled by the treasury team centrally
in establishing and monitoring counterparty
limits, which are set according to the assessed
risk of each counterparty. Centrally managed
funds are invested entirely with counterparties
whose credit rating is ‘A’ or better. During the
year, funds held in money market funds have
been progressively transferred to US Treasury
funds, in light of the ongoing financial crisis.
External fund managers, who manage
$3.0 billion of the Group’s cash, are rated
AAA by Standard & Poor’s.
are presented in US dollars and exposures
are managed against US dollars accordingly.
Approximately 57% of Group external sales
in 2008 were denominated in currencies
other than the US dollar, while a significant
proportion of manufacturing and R&D costs
were denominated in sterling and Swedish
krona. Surplus cash generated by business
units is substantially converted to, and held
centrally, in US dollars. As a result, operating
profit and total cash flow in US dollars will be
affected by movements in exchange rates.
This currency exposure is managed centrally
based on forecast cash flows for the
currencies of Swedish krona, sterling, euro,
Australian dollar, Canadian dollar and
Japanese yen. The impact of movements
in exchange rates is mitigated significantly
by the correlations which exist between
the major currencies to which the Group is
exposed and the US dollar. Monitoring of
currency exposures and correlations is
undertaken on a regular basis and hedging
is subject to pre-execution approval. Except
as noted below, no hedges were outstanding
at the year-end.
The Group will hold debt in non-US dollar
currencies to the extent that there is an
underlying net investment in the same
currency and therefore a net investment
hedge as defined by IFRS 7, can be applied.
The €500 million 2010 bond issued in 2008
was issued in euros to match investors’
appetite but currency swaps were transacted
to convert it into a US dollar instrument. As
at 31 December 2008, after currency swaps,
4.2% of interest bearing loans and borrowings
were denominated in sterling and 17.8% of
interest bearing loans and borrowings were
denominated in euros.
The transaction exposures that arise from
non-local currency sales and purchases by
subsidiaries are, where practicable, fully
hedged using forward foreign exchange
contracts. In addition, the Group’s external
dividend, which is paid principally in sterling
and Swedish krona, is fully hedged from
announcement to payment date.
Sensitivity analysis considering the Group’s
exposure to exchange rate movements is
detailed in Note 16 to the Financial Statements
on pages 122 to 126.
Interest rate risk
The Group maintains a mix of fixed and floating
rate debt. The portion of fixed rate debt was
approved by the Board and any variation
requires Board approval. A significant portion
Our risk management objectives and policies
are described in further detail below and in
the Risk section on pages 74 to 82.
Capital management
The capital structure of the Group consists
of shareholders equity (see Note 20 on page
129), debt (see Note 14 on page 119) and
cash (see Note 13 on page 119). For the
foreseeable future, the Board will maintain
a capital structure that supports the Group’s
strategic objectives through:
Managing funding and liquidity risk >
Optimising shareholder return >
Maintaining a strong investment >
grade rating
Funding and liquidity risk are reviewed
regularly by the Board and managed in
accordance with policies described below.
The Boards distribution policy comprises
both a regular cash dividend and, subject
to business needs, a share re-purchase
component. The Board regularly reviews its
shareholders’ return strategy, and for 2008
reaffirmed the current dividend policy, which
is to grow dividends in line with reported
earnings before restructuring and synergy
costs, with an aim to maintain at least two
times dividend cover. With respect to share
re-purchases, the Board decided in quarter
three that no further share re-purchases
should take place in 2008 in order to maintain
the flexibility to invest in the business. For the
same reason, the Board has decided that no
share re-purchases will take place in 2009.
The Group’s current long-term credit rating
is A1 by Moody’s and AA- by Standard and
Poor’s, both with a stable outlook.
Liquidity risk
The Board reviews the Group’s ongoing
liquidity risks annually as part of the planning
process. The Board considers short-term
requirements against available sources of
funding taking into account cash flow.
The Group manages liquidity risk by
maintaining access to a number of sources
of funding, which are sufficient to meet
anticipated funding requirements. Specifically,
the Group uses US commercial paper,
committed bank facilities and cash resources
to manage short-term liquidity and manages
long-term liquidity by raising funds through
the capital markets. Facilities available to the
Group are detailed in Note 15 to the Financial
Statements on pages 120 to 121.
Foreign exchange
The US dollar is the Group’s most significant
currency. As a consequence, the Group results
DIREcTORs’ REPORT
43
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
The effects of these deductions on our US
pharmaceuticals turnover are set out below.
Accrual assumptions are built up on a
product-by-product and customer-by-
customer basis taking into account specific
contract provisions coupled with expected
performance and are then aggregated into
a weighted average rebate accrual rate for
each of our products. Accrual rates are
reviewed and adjusted on a monthly basis.
There may be further adjustments when
actual rebates are invoiced based on
utilisation information submitted to us (in
the case of contractual rebates) and claims/
invoices are received (in the case of regulatory
rebates and chargebacks). We believe that
we have been reasonable in our estimates for
future rebates using a similar methodology to
that of previous years. Inevitably, however, such
estimates involve judgements on aggregate
future sales levels, segment mix and the
respective customer contractual performance.
Cash discounts are offered to customers to
encourage prompt payment. Accruals are
calculated based on historical experience
and are adjusted to reflect actual experience.
Industry practice in the US allows
wholesalers and pharmacies to return
unused stocks within six months of, and up
to 12 months after, shelf-life expiry. At point
of sale, we estimate the quantity and value
of goods which may ultimately be returned.
Our returns accruals are based on actual
experience over the preceding 12 months
for established products together with
market related information such as
estimated stock levels at wholesalers and
competitor activity. For newly launched
products, we use rates based on our
experience with similar products or a
pre-determined percentage.
customer depending on local trading terms.
Income from royalties and from disposals of
intellectual property, brands and product lines
are included in other operating income.
Rebates and chargebacks
At the time of invoicing sales in the US, rebates
and chargebacks that we expect to pay, in as
little time as two weeks or as much as eight
months, are estimated. These rebates typically
arise from sales contracts with third party
managed care organisations, hospitals,
long-term care facilities, group purchasing
organisations and various federal or state
programmes (Medicaid “best price” contracts,
supplemental rebates etc) and can be
classified as follows:
Chargebacks, where we enter into >
arrangements under which certain parties,
typically hospitals, the Department of
Veterans Affairs and the Department of
Defense, are able to buy products from
wholesalers at the lower prices we have
contracted with them. The chargeback
is the difference between the price
we invoice to the wholesaler and
the contracted price charged by the
wholesaler. Chargebacks are paid
directly to the wholesalers.
Regulatory, including Medicaid and other >
federal and state programmes, where we
pay rebates based on the specific terms
of agreements in individual states which
include product usage and information
on best prices and average market
prices benchmarks.
Contractual, under which entities such as >
third party managed care organisations,
long-term care facilities and group
purchasing organisations are entitled
to rebates depending on specified
performance provisions, which vary
from contract to contract.
CRITICAl ACCouNTINg polICIES
ANd ESTImATES
Our Financial Statements are prepared in
accordance with International Accounting
Standards and International Financial Reporting
Standards (collectively “IFRSs”) as adopted
by the European Union (“adopted IFRS”) and
as issued by the International Accounting
Standards Board and the accounting policies
employed are set out under the heading
Financial Statements Accounting Policieson
pages 103 to 107. In applying these policies,
we make estimates and assumptions that
affect the reported amounts of assets and
liabilities and disclosure of contingent assets
and liabilities. The actual outcome could differ
from those estimates. Some of these policies
require a high level of judgement, either
because the areas are especially subjective
or complex. We believe that the most critical
accounting policies and significant areas of
judgement and estimation are in:
Revenue recognition >
Research and development >
Goodwill and intangible assets >
Litigation >
Post-retirement benefits >
Taxation >
Share-based compensation. >
REVENuE RECogNITIoN
Revenue is recorded at the invoiced amount
(excluding inter-company sales and value
added taxes) less movements in estimated
accruals for product returns and rebates
given to managed care and other customers
– a particular feature in the US but also
occurring in the rest of the world. Cash
discounts for prompt payment are also
deducted from sales. Revenue is recognised
at the point of delivery, which is usually when
title passes to the customer either on
shipment or on receipt of goods by the
2008 2007 2006
$m $m $m
Gross sales 20,029 18,456 16,577
Chargebacks (1,726) (1,130) (975)
Regulatory – US government and state programmes (1,005) (732) (532)
Contractual – Managed care and group purchasing organisation rebates (3,658) (3,179) (2,413)
Cash and other discounts (390) (356) (329)
Customer returns (48) (18) (46)
Other (167) (145) (256)
Net sales 13,035 12,896 12,026
44
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
The increase in contractual rebates in 2007
was driven by the introduction into the US
market of generic omeprazole, with resultant
price impacts on Nexium.
We have Distribution Service Agreements with
major wholesaler buyers, which serve to
reduce the speculative purchasing behaviour
of the wholesalers and reduce short-term
fluctuations in the level of inventory they hold.
As a result, we believe inventory movements
have been neutral across the year. We track
wholesaler stock levels by product, using our
own, third party and wholesaler data and,
where we believe such distortions occur,
we disclose in the Annual Report for each
product and in aggregate where shipments
may be out of line with underlying prescription
trends. We do not offer any incentives to
encourage wholesaler speculative buying
and attempt, where possible, to restrict
shipments to underlying demand when
such speculation occurs.
vary from product to product depending
on the specific circumstances.
The movements on US pharmaceuticals
revenue accruals, are set out below.
The adjustments in respect of prior years
benefited reported US pharmaceuticals
turnover by 0.4% in 2006, and decreased
turnover by 0.4% in 2007 and 0.2% in 2008.
Chargebacks increased by $173 million
compared to 2007 due primarily to increased
sales activities with US Government Agencies
for Nexium and Crestor. Regulatory rebates
increased by $92 million in 2008 largely as
a result of increased US State supplemental
rebates for our key brands. In 2008 contractual
rebates increased by $184 million compared
to 2007, mainly as a result of AstraZeneca’s
response to increased generic and competitor
pricing pressures particularly in the PPI and
statin markets.
For products facing generic competition
(such as Ethyol and Toprol-XL in the US) our
experience is that we usually lose the ability
to estimate the levels of returns from
wholesalers with the same degree of
precision that we can for products still
subject to patent protection. This is because
we have limited or no insight into a number
of areas – the actual timing of the launch of
a generic competitor following regulatory
approval of the generic product (for
example, a generic manufacturer may or
may not have produced adequate pre-
launch inventory), the pricing and marketing
strategy of the competitor, the take-up of the
generic and (in cases where a generic
manufacturer has approval to launch just one
dose size in a market of several dose sizes)
the likely level of switching from one dose to
another. Under our accounting policy revenue
is only recognised when the amount of the
revenue can be measured reliably. Our
approach in meeting this condition for
products facing generic competition will
Adjustment Carried forward
Brought forward Provision for in respect Returns at 31 December
1 January 2006 current year of prior years and payments 2006
$m $m $m $m $m
Chargebacks 185 1,001 (26) (1,068) 92
Regulatory – US government and state programmes 601 597 (65) (819) 314
Contractual – Managed care and group purchasing organisation rebates 420 2,367 46 (2,198) 635
Cash and other discounts 27 329 (327) 29
Customer returns 167 46 (53) 160
Other 54 256 (263) 47
1,454 4,596 (45) (4,728) 1,277
Additions in Adjustment Carried forward
Brought forward respect of Provision for in respect Returns at 31 December
1 January 2007 MedImmune current year of prior years and payments 2007
$m $m $m $m $m $m
Chargebacks 92 2 1,115 15 (1,038) 186
Regulatory – US government and state programmes 314 69 769 (37) (687) 428
Contractual – Managed care and group purchasing organisation rebates 635 5 3,100 79 (2,919) 900
Cash and other discounts 29 1 356 (348) 38
Customer returns 160 1 19 (1) (94) 85
Other 47 153 (147) 53
1,277 78 5,512 56 (5,233) 1,690
Adjustment Carried forward
Brought forward Provision for in respect Returns at 31 December
1 January 2008 current year of prior years and payments 2008
$m $m $m $m $m
Chargebacks 186 1,745 (19) (1,553) 359
Regulatory – US government and state programmes 428 997 8 (913) 520
Contractual – Managed care and group purchasing organisation rebates 900 3,622 36 (3,474) 1,084
Cash and other discounts 38 390 (389) 39
Customer returns 85 48 (56) 77
Other 53 167 (163) 57
1,690 6,969 25 (6,548) 2,136
DIREcTORs’ REPORT
45
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
discount rate reflecting those risks and tax
effects. In arriving at the appropriate discount
rate for each group of cash flows, we adjust
AstraZeneca’s post-tax weighted average
cost of capital (7.6% for 2008) to reflect the
impact of risks and tax effects. The weighted
average pre-tax discount rate we used was
approximately 11%.
As a cross check, we compare our market
capitalisation to the book value of our net
assets and this indicates significant surplus
at 31 December 2008.
No goodwill impairment was identified.
The Group has also performed sensitivity
analysis calculations on the projections used
and discount rate applied. The Directors
have concluded that, given the significant
headroom that exists, and the results of the
sensitivity analysis performed, there is no
significant risk that reasonable changes in
key assumptions would cause the carrying
value of goodwill to exceed its value in use.
Impairment reviews have been carried out
on all intangibles that are in development
(and not being amortised), all major intangibles
acquired during the year, all intangibles that
have had indications of impairment during
the year and all intangibles recognised on the
acquisition of MedImmune. Sales forecasts
and specific allocated costs (which have
both been subject to appropriate Senior
Management sign off) are discounted using
AstraZeneca’s post-tax weighted average
cost of capital.
The majority of our investments in intangible
assets and goodwill arose from the
restructuring of the Astra-Merck joint venture
in 1998, the acquisition of MedImmune in
2007 and the payment to partially retire
Merck’s interests in our products in the US in
2008, and we are satisfied that the carrying
values are fully justified by estimated future
cash flows.
lITIgATIoN
In the normal course of business, potential
liabilities may arise from product-specific and
general legal proceedings, from guarantees
or from environmental liabilities connected
with our current or former sites. Where we
believe that potential liabilities have a less
than 50% probability of crystallising or are
very difficult to quantify reliably, we treat them
as contingent liabilities.
of the intangible asset. This is because the
contracted revenue relating to the undelivered
component is contingent on future events
(such as sales) and so cannot be anticipated.
RESEARCh ANd dEVElopmENT
Our business is underpinned by our marketed
products and development portfolio. The R&D
expenditure on internal activities to generate
these products is generally charged to the
income statement in the year that it is incurred.
Purchases of intellectual property and product
rights to supplement our R&D portfolio are
capitalised as intangible assets. Such intangible
assets are amortised from the launch of the
underlying products and are tested for
impairment both before and after launch.
This policy is in line with practice adopted by
major pharmaceutical companies.
goodWIll ANd INTANgIBlE ASSETS
We have significant investments in goodwill
and intangible assets as a result of acquisitions
of businesses and purchases of such assets
as product development and marketing rights.
For the purpose of impairment testing of
goodwill, the Group is regarded as a single
cash-generating unit.
The recoverable amount is based on value in
use using discounted risk-adjusted projections
of the Group’s pre-tax cash flows over ten
years, a period reflecting the average
patent-protected lives of our current products.
The projections include assumptions about
product launches, competition from rival
products and pricing policy as well as the
possibility of generics entering the market.
In setting these assumptions we consider
our past experience, external sources of
information (including information on expected
increases and ageing of the populations in
our Established Markets and the expanding
patient population in newer markets),
our knowledge of competitor activity and
our assessment of future changes in the
pharmaceutical industry. The 10 year period
is covered by internal budgets and forecasts.
Given that internal budgets and forecasts
are prepared for all projections, no general
growth rates are used to extrapolate internal
budgets and forecasts for the purposes of
determining value in use.
In arriving at value in use, we disaggregate
our projected pre-tax cash flows into groups
reflecting similar risks and tax effects. For each
group of cash flows we use an appropriate
Royalty income
Royalty income is recorded under other
operating income in the Financial Statements.
Royalties tend to be linked to levels of sales
or production by a third party. At the time of
preparing the Financial Statements, we may
have to estimate the third party’s sales or
production when arriving at the royalty
income to be included. These estimates,
which may differ from actual sales or
production, do not result in a material impact
on reported other operating income.
Sales of intangible assets
A consequence of charging all internal R&D
expenditure to the income statement in the
year that it is incurred (which is normal
practice in the pharmaceutical industry) is
that we own valuable intangible assets which
are not recorded on the balance sheet.
We also own acquired intangible assets
which are included on the balance sheet.
As a consequence of regular reviews of
product strategy, from time to time we sell
such assets and generate income. Sales
of product lines are often accompanied
by an agreement on our part to continue
manufacturing the relevant product for a
reasonable period (often about two years)
whilst the purchaser constructs its own
manufacturing facilities. The contracts typically
involve the receipt of an upfront payment,
which the contract attributes to the sale of
the intangible assets, and ongoing receipts,
which the contract attributes to the sale of
the product we manufacture. In cases where
the transaction has two or more components,
we account for the delivered item (for example,
the transfer of title to the intangible asset) as
a separate unit of accounting and record
revenue on delivery of that component
provided that we can make a reasonable
estimate of the fair value of the undelivered
component. Where the fair market value of
the undelivered component (for example
a manufacturing agreement) exceeds the
contracted price for that component we
defer an appropriate element of the upfront
consideration and amortise this over the
performance period. However, where the fair
market value of the undelivered component
is equal to or lower than the contracted price
for that component we treat the whole of the
upfront amount as being attributable to the
delivered intangible assets and recognise that
part of the revenue upon delivery. No element
of the contracted revenue related to the
undelivered component is allocated to the sale
46
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
Included in the total net accrual are
amounts in respect of the following transfer
pricing arrangements:
AstraZeneca and Her Majesty’s Revenue >
& Customs (HMRC) have made a joint
referral to the UK Court in respect of
transfer pricing between our UK and one
of our overseas operations for the years
1996 to date as there continues to be a
material difference between the Groups
and HMRC’s positions. An additional
referral in respect of controlled foreign
company aspects of the same case was
made during 2008. Absent a negotiated
settlement, litigation is set to commence
in 2010.
AstraZeneca has applied for two advance >
pricing agreements (APAs) in relation to
intra-group transactions between the UK
and the US and the UK and Japan. Both
APAs are being progressed through
competent authority proceedings under
the relevant double tax treaties.
Management continues to believe that
AstraZeneca’s positions on all its transfer
pricing audits and disputes are robust and
that AstraZeneca is adequately provided.
For transfer pricing audits where AstraZeneca
and the tax authorities are in dispute,
AstraZeneca estimates the potential for
reasonably possible additional losses above
and beyond the amount provided to be
up to $400 million; however, management
believes that it is unlikely that these additional
losses will arise. Of the remaining tax
exposures, AstraZeneca does not expect
material additional losses. It is not possible
to estimate the timing of tax cash flows in
relation to each outcome, however, it is
anticipated that a number of significant
disputes may be resolved over the next
one to two years. Included in the provision
is an amount of interest of $365 million.
results in a broad diversification of investment
styles and asset classes. The investment
approach is intended to produce less volatility
in the plan asset returns.
In assessing the discount rate applied to
the obligations, we have used rates on AA
corporate bonds with durations corresponding
to the maturities of those obligations.
In all cases, the pension costs recorded
in the Financial Statements are assessed in
accordance with the advice of independent
qualified actuaries but require the exercise of
significant judgement in relation to assumptions
for future salary and pension increases, long-
term price inflation and investment returns.
TAxATIoN
Accruals for tax contingencies require
management to make judgements and
estimates in relation to tax audit issues and
exposures. Amounts accrued are based on
management’s interpretation of country-specific
tax law and the likelihood of settlement. Tax
benefits are not recognised unless the tax
positions are probable of being sustained.
Once considered to be probable, management
reviews each material tax benefit to assess
whether a provision should be taken against
full recognition of the benefit on the basis of
potential settlement through negotiation and/
or litigation. All such provisions are included
in creditors due within one year. Any recorded
exposure to interest on tax liabilities is provided
for in the tax charge.
AstraZeneca faces a number of transfer pricing
audits in jurisdictions around the world and,
in some cases, is in dispute with the tax
authorities. These disputes usually result in
taxable profits being increased in one territory
and correspondingly decreased in another.
Our balance sheet positions for these matters
reflect appropriate corresponding relief in
the territories affected. The total net accrual
included in the Financial Statements to cover
the worldwide exposure to transfer pricing
audits is $1,628 million, an increase of
$306 million due to a number of new audits,
revisions of estimates relating to existing
audits, offset by a number of negotiated
settlements and exchange rate effects.
These are not provided for but are disclosed
in the Notes to the Financial Statements.
Further details of these contingent liabilities
are set out in Note 25 on page 144. Where
it is considered more likely than not that an
actual liability may crystallise, and this can
be measured reliably, a provision is made.
Although there can be no assurance regarding
the outcome of legal proceedings, we do not
currently expect them to have a materially
adverse effect on our results in any particular
period. We also have significant commitments
that are not currently recognised in the balance
sheet arising from our relationship with Merck.
These are described more fully in Note 25 to
the Financial Statements on page 144.
poST-RETIREmENT BENEFITS
We offer post-retirement benefit plans which
cover many of our employees around the
world. In keeping with local terms and
conditions, most of these plans are ‘defined
contribution’ in nature where the resulting
income statement charge is fixed at a set
level or is a set percentage of employees’
pay. However, several plans, mainly in the
UK (which has by far the largest single
scheme), the US and Sweden, are defined
benefit plans where benefits are based on
employees’ length of service and final salary
(typically averaged over one, three or five
years). The UK and US defined benefit
schemes were closed to new entrants in
2000. All new employees in these countries
are offered defined contribution schemes.
In applying IAS 19 ‘Employee Benefits’,
we recognise all actuarial gains and
losses immediately through reserves. This
methodology results in a less volatile income
statement charge than under the alternative
approach of recognising actuarial gains
and losses over time. Investment decisions
in respect of defined benefit schemes are
based on underlying actuarial and economic
circumstances with the intention of ensuring
that the schemes have sufficient assets to
meet liabilities as they fall due, rather than
meeting accounting requirements. The trustees
follow a strategy of awarding mandates to
specialist, active investment managers which
DIREcTORs’ REPORT
47
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
Our approach to the assessment has been to
select key transaction and financial reporting
processes in our largest operating units and
a number of specialist areas such as financial
consolidation and reporting, treasury
operations and taxation so that, in aggregate,
we have covered a significant proportion of
each of the key line items in our Financial
Statements. Each of these operating units
and specialist areas has ensured that its
relevant processes and controls are
documented to appropriate standards,
taking into account, in particular, the
guidance provided by the Securities and
Exchange Commission. We have also
reviewed the structure and operation of our
“entity level” control environment. This refers
to the overarching control environment,
including structure of reviews, checks
and balances that are essential to the
management of a well controlled business.
The Directors have concluded that our internal
control over financial reporting is effective as
at 31 December 2008 and the assessment
is set out on page 98. KPMG Audit Plc have
audited the effectiveness of internal control
over financial reporting and, as noted on
page 99, their report is unqualified.
ShARE-BASEd CompENSATIoN
Through the Remuneration Committee we
offer share and share option plans to certain
employees as part of their compensation
and benefits packages, designed to improve
alignment of the interests of employees
with shareholders. Costs of the plans are
determined using valuation models such as
Black-Scholes or a modified version of the
binomial model. Valuation models require
judgements to be made on inputs to the
model. Further details of these are given
in Note 24 to the Financial Statements.
oFF-BAlANCE ShEET TRANSACTIoNS
ANd CommITmENTS
We have no off-balance sheet arrangements
and our derivative activities are non-speculative.
The table above sets out our minimum
contractual obligations at the year end.
oThER ACCouNTINg INFoRmATIoN
INTERNATIoNAl ACCouNTINg TRANSITIoN
On transition to using adopted IFRS in the
year ended 31 December 2005, we took
advantage of several optional exemptions
available in IFRS 1 ‘First-time Adoption of
International Financial Reporting Standards’.
The major effects of these exemptions are
detailed on page 106.
NEW ACCouNTINg STANdARdS
New International Financial Reporting
Standards which have been issued (both
adopted and not yet adopted) are discussed
on pages 103 to 107.
SARBANES-oxlEY ACT SECTIoN 404
As a consequence of our listing on the
New York Stock Exchange, AstraZeneca is
required to comply with those provisions of
the US Sarbanes-Oxley Act applicable to
foreign issuers. Section 404 of this legislation
requires companies annually to assess and
make public statements about the quality
and effectiveness of their internal control over
financial reporting.
pAYmENTS duE BY pERIod
Less than 1 year 1-3 years 3-5 years Over 5 years Total
$m $m $m $m $m
Bank loans and other borrowings 1,616 2,800 2,665 12,478 19,559
Operating leases 101 131 81 145 458
Contracted capital expenditure 332 332
Total 2,049 2,931 2,746 12,623 20,349
48
ASTRAZENECA ANNUAL REPORT AND FORM 20-F INFORMATION 2008
2008 IN BRIEF
Despite a continually challenging environment, >
including generic pressure, combined sales of
Arimidex, Crestor, Nexium, Seroquel and Symbicort
up 5% in the US – 65% of our total US sales.
Maintained market position as the second largest >
brand name pharmaceutical company in Canada.
Solid sales performance in the Rest of World, >
up 5%.
Strong brand performance in Western Europe but >
intense competition and governmental controls
over healthcare expenditure.
Strong volume growth from key products, >
Crestor, Losec and Seroquel in Japan.
Emerging Rest of World delivers strong sales >
growth, up 16% with Emerging Europe sales
up 10% and Emerging Asia sales up 10%.
Continued expansion in China, including >
continued sales growth up 31%.
EU Commission of a Sectoral Inquiry into the >
pharmaceutical industry continues, with a final
report expected in Spring 2009.
NORTH AMERICA
US
Despite full generic competition to Toprol-XL
and the growth in generic omeprazole, sales
in the US increased 1% in 2008 to $13,510
million (2007: $13,366 million). Combined sales
of Arimidex, Crestor, Nexium, Seroquel,
and Symbicort were up 5% to $8,803 million
(2007: $8,414 million) – 65% of our total
US sales. AstraZeneca is currently the third
largest pharmaceutical company in the US,
with a 5.6% share of US prescription
pharmaceutical sales. Sales for Aptium
Oncology and Astra Tech fell by 2% and rose
by 33% to $395 million (2007: $402 million)
and $80 million (2007: $60 million), respectively.
Nexium continues to lead the branded
proton pump inhibitor (PPI) market for new
prescriptions, total prescriptions and total
capsules dispensed. Generic pantoprazole
showed strong growth after being introduced
late in 2007 and together with generic
omeprazole captured most of the market
growth, resulting in price and share erosion
across the entire branded PPI market. In the
face of generic pressure, Nexium continued
to fare better than its branded competitors
with sales in 2008 down 8% to $3,101 million
(2007: $3,383 million). During the year, the US
Food and Drug Administration (FDA) approved
the use of Nexium in children ages one to 11
years old for the short-term treatment of
gastroesophageal reflux disease.
Seroquel maintained its strong position as
the number one prescribed atypical anti-
psychotic on the market, with sales up 5%
to $3,015 million (2007: $2,863 million).
Seroquel posted total prescription growth
of 6.6% with an increase of one million
prescriptions, outpacing the rate of market
growth for anti-psychotics by almost two
points, leading the market in absolute total
prescription growth. During the year, the FDA
approved Seroquel for the maintenance of
bipolar disorder as adjunct therapy to lithium
or divalproex. The FDA also approved
Seroquel XR for the depressive episodes of
bipolar disorder, the manic or mixed episodes
associated with bipolar I disorder (as either
monotherapy or adjunct therapy to lithium or
divalproex), and for maintenance treatment of
bipolar disorder as adjunct therapy to lithium
or divalproex.
Supplemental new drug applications
(sNDAs) were submitted to the FDA for use
of Seroquel XR in adult patients for major
depressive disorder (MDD) and generalised
anxiety disorder (GAD). In December 2008,
we received a Complete Response Letter
from the FDA related to the MDD submission,
while the GAD submission remains under
review. We also submitted an sNDA to
the FDA for use of Seroquel for treatment
of schizophrenia in 13 to 17 year olds and
for treatment of acute manic episodes of
bipolar I disorder for 10 to 17 year olds.
The US Prescribing Information for Seroquel
and Seroquel XR is being updated to include
new safety information regarding use in children
and adolescents. Seroquel and Seroquel XR
are not approved currently for use in paediatric
patients under 18 years of age.
Crestor sales were up 18% to $1,678 million
(2007: $1,424 million) with a total prescription
growth of 10.8%, and was the only branded
statin to grow in total prescriptions throughout
2008 despite generic pressure. The new
indication to slow the progression of
atherosclerosis in adult patients with elevated
cholesterol, an important differentiator from
other products in the cholesterol-lowering
market, was successfully introduced and
awareness amongst physicians is high.
Under the terms of an agreement executed
in November 2008, Abbott obtained the
non-exclusive right to promote Crestor
alongside AstraZeneca in the US (excluding
Puerto Rico) increasing Crestors profile
and share of voice. New data presented in
November 2008 from the JUPITER study
demonstrated that Crestor 20mg significantly
reduced major cardiovascular (CV) events –
defined by the study as the combined risk
of myocardial infarction, stroke, arterial
revascularisation, hospitalisation for unstable
angina, or death from CV causes – by 44%
compared to placebo among men and
women with elevated hsCRP (high-sensitivity
C-reactive protein) but low to normal
cholesterol levels. hsCRP is a recognised
marker of inflammation that is associated
with an increased risk of atherosclerotic CV
events. The JUPITER results also showed
that for patients in the trial taking Crestor,
the combined risk of heart attack, stroke or CV
death was reduced by nearly half. We expect
to file a regulatory submission with the FDA
that includes the JUPITER data in the first half
of 2009 and, if approved, will begin promotional
activities within the approved labelling.
GEOGRAPHICAL REVIEW
For more information regarding our products
please refer to the relevant sections of the
Therapy Area Review from page 53. Details
of relevant continuing litigation can be found
in Note 25 to the Financial Statements (from
page 144) and details of relevant risks are set
out in the Principal Risks and Uncertainties
section (from page 76).
For the AstraZeneca definition of markets
please see the Glossary on page 199.
DIRECtORs’ REPORt
49
ASTRAZENECA ANNUAL REPORT AND FORM 20-F INFORMATION 2008
OUR FINANCIAL PERFORMANCE
2008 2007 2006 2008 compared to 2007 2007 compared to 2006
Growth due Growth due
CER to exchange CER to exchange CER Reported CER Reported
Sales growth effect Sales growth effect Sales growth growth growth growth
$m $m $m $m $m $m $m % % % %
US 13,510 142 2 13,366 917 12,449 1 1 7 7
Canada 1,275 95 35 1,145 54 60 1,031 8 11 5 11
North America 14,785 237 37 14,511 971 60 13,480 2 2 7 8
Western Europe 9,743 55 573 9,115 282 760 8,073 1 7 3 13
Japan 1,957 73 223 1,661 170 (12) 1,503 4 18 11 11
Other Established ROW 843 107 21 715 83 77 555 15 18 15 29
Established ROW 12,543 235 817 11,491 535 825 10,131 2 9 5 13
Emerging Europe 1,215 102 85 1,028 102 95 831 10 18 12 24
China 627 136 54 437 91 18 328 31 43 28 33
Emerging Asia Pacific 802 72 (19) 749 62 41 646 10 7 10 16
Other Emerging ROW 1,629 247 39 1,343 223 61 1,059 18 21 21 27
Emerging ROW 4,273 557 159 3,557 478 215 2,864 16 20 17 24
Total sales 31,601 1,029 1,013 29,559 1,984 1,100 26,475 3 7 7 12
In another agreement with Abbott, we are
investigating the fixed dose combination of
the active ingredients in Crestor (rosuvastatin
calcium) and Trilipix
(fenofibric acid) for the
treatment of mixed dyslipidaemia. A Phase III
trial in 2008 demonstrated that a combination
of rosuvastatin calcium and fenofibric acid
delivers greater improvements in treating all
three key lipids (LDL, HDL and triglycerides)
than the pre-specified monotherapy
comparators. Currently, dyslipidaemia
affects more than 100 million US residents
and has been shown to play a pivotal role
in the development of atherosclerosis and
consequently, cardiovascular disease. Patients
with mixed dyslipidaemia are expected to
become more prominent segments of the
dyslipidaemic population. Abbott obtained
approval of Trilipix
in December 2008 as
the first and only fibrate labelled for use with
a statin.
To maximise the value of Merrem IV during
the year we announced an agreement with
Cubist, who will provide promotional and
scientific affairs support for Merrem IV in the
US and Puerto Rico.
Arimidex continued to perform well with sales
up 9% to $754 million (2007: $694 million)
for the full year. Arimidex continues to be
the market leader in new prescriptions for
branded hormonal treatments for breast
cancer in the US.
In September 2008, an additional six-month
period of exclusivity was granted to market
Casodex for its licensed advanced prostate
cancer indication until 1 April 2009.
Pulmicort Respules, the only inhaled
corticosteroid for the treatment of asthma
approved in the US for children as young
as 12 months, showed strong sales
growth with sales up 2% to $982 million
(2007: $964 million). On 23 September 2008,
the US District Court for the District of
New Jersey denied a motion filed by Teva
Pharmaceuticals Ltd. for summary judgment
of no infringement in the Pulmicort Respules
patent litigation. On 19 November 2008, the
same court awarded a temporary restraining
order against Teva Pharmaceuticals after
Teva launched its generic product ‘at risk’ on
18 November 2008. On 25 November 2008,
the parties settled the matter and AstraZeneca
granted Teva a licence to launch its generic
product in late 2009.
In its first full year after launch in June 2007,
Symbicort Rapihaler (pMDI) continued to
deliver steady growth with sales up 410% to
$255 million (2007: $50 million). Widespread
physician experience and growing appreciation
of the differentiating feature of control plus
fast onset has led to the product surpassing
a 10% new prescription share of the inhaled
corticosteroid/long acting beta agonist market.
Symbicort is now prescribed to one in five of
all patients that are new to combination therapy.
In 2008, two sNDAs were submitted to the
FDA: one for the use of Symbicort in chronic
obstructive pulmonary disease and another
for its use in paediatric asthma for ages six to
12. In October 2008, the pMDI device was
enhanced with an actuation counter.
Synagis is the only FDA-approved monoclonal
antibody (MAb) to help protect high-risk babies
against severe Respiratory Syncytial Virus (RSV)
disease. In its first full year in AstraZeneca,
sales in the US were $923 million.
In 2008, distribution agreements continued
with Par Pharmaceutical for all available
strengths of generic metoprolol succinate.
Also, Ranbaxy Pharmaceuticals began
distribution of authorised generics of both
felodipine and 40mg omeprazole.
Currently, there is no direct government control
of prices for commercial prescription drug sales
in the US. However, some publicly funded
programmes such as Medicaid and TRICARE
(Department of Veterans Affairs) – have
statutorily mandated rebates that have the
effect of price controls for these programmes.
Additionally, pressure on pricing, availability
and utilisation of prescription drugs for both
commercial and public payers continues
to increase, driven by, among other things,
an increased focus on generic alternatives.
Primary drivers of increased generic use are
budgetary policies within healthcare systems
and providers, including the use of “generics
only” formularies, and increases in patient
co-insurance or co-payments. While it is
unlikely that there will be widespread
adoption of a broad national price control
scheme in the near term, there will continue
to be increased attention to pharmaceutical
prices and their impact on healthcare costs
for the foreseeable future.
50
ASTRAZENECA ANNUAL REPORT AND FORM 20-F INFORMATION 2008
the maximum non-excessive price in the
market. For patients to gain optimal access
to medicines, they then need to be listed on
provincial formularies. This long process means
patients in Canada can typically wait over
two years following the regulatory approval
for access to be granted.
The different provinces have adopted different
approaches to pharmaceutical funding, from
one end of the continuum in Quebec with
more open access to more restricted access,
therapeutic substitution and price tendering
on the horizon in British Colombia. The trend
in Canada indicates provinces will increase
their access restrictions and drive prices down
while the complex reimbursement system will
continue to result in access delays.
REST OF WORLD
Sales in the rest of the world performed
strongly in 2008, up 5% (+12% reported)
to $16,816 million (2007: $15,048 million).
Key products (Arimidex, Crestor, Nexium,
Seroquel and Symbicort) delivered a strong
performance, up 14% (+20% reported) with
sales of $7,413 million (2007: $6,189 million).
Latin America, the Middle East and Africa
and Asia Pacific regions delivered particularly
strong sales, up 13% (+19% reported) with
sales of $5,858 million (2007: $4,906 million).
ESTABLISHED REST OF WORLD
Sales in our Established Rest of World Markets
increased by 2% (+9% reported), with good
growth from Crestor, Seroquel and Symbicort
and our oncology products, together with
Synagis, offsetting declines in sales of our
proton pump inhibitors in Western Europe.
WESTERN EUROPE
In Western Europe, we saw a flat market
with overall growth of 1% (+7% reported).
This reflected decreasing sales in France
(down 1%, +7% reported), Germany (down
2%, +6% reported), Italy (down 6%, +2%
reported) and Spain (down 8%, -1% reported),
partly offset by strong growth in the UK
(up 8%, +2% reported). Sales in established
European markets were mainly impacted by
the loss of patent/marketing exclusivity on
Casodex, by government initiatives to contain
drug expenditures and by the loss of sales
due to an ageing portfolio of mature brands.
These impacts were partly offset by continued
strong performance of key products (mainly
Crestor and Seroquel).
Additionally, AstraZeneca has been providing
patient assistance to the uninsured for 30
years and, in the last six years, has provided
more than $3 billion in savings to more than
one million patients in the US and Puerto
Rico. Last year alone, we provided more
than $612 million in savings to approximately
440,000 people without drug coverage
(approximately 2.7 million prescriptions).
CANADA
Despite the entry of the generic forms of
Seroquel IR, sales in Canada increased by
8% (+11% reported) to $1,275 million
(2007: $1,145 million). Combined sales of
Crestor, Nexium, Seroquel and Atacand
were up 18% to over $864 million (2007:
$713 million) with Crestor, Seroquel and
Nexium among the top 20 prescription
products in Canada by sales.
We remain the second largest brand name
pharmaceutical company in Canada. Crestor
maintained its number two ranking in the statin
market and was the fastest-growing product
in both new and total prescription segments
(25.9% and 32.0% growth respectively).
Crestor is also the third largest product in
Canada by sales. Together, Seroquel XR
and Seroquel IR remain the leaders in new
and total prescriptions within the atypical
anti-psychotics market. Atacand continues
to outperform the anti-hypertensive market,
with total prescription growth of over 15.0%
compared with market growth of only 7.4%.
Several key regulatory approvals were
achieved in Canada in 2008. Canada was
the first country in which we gained regulatory
approval for Seroquel XR for the treatment
of bipolar mania, with Seroquel XR and
Seroquel IR also approved for the treatment of
bipolar depression (approvals were received
eight months and five months respectively
ahead of standard Health Canada review
timelines). In addition, a new tablet strength
for Atacand (32mg) was approved by
Health Canada.
Organisational efficiencies were gained with the
closure of the Canadian packaging plant and
transfer of product packaging to the Newark,
Delaware facility, and further efficiencies were
obtained through the movement to common
North American technology platforms.
The Canadian government has instituted
a Health Technology Assessment appraisal
system through their Common Drug review
process which rejects almost six out of 10
new medications. The Patented Medicine
Prices Review Board has the role of setting
In the current political climate, policymakers
are likely to consider healthcare reform
a top priority. The reauthorisation of the
State Childrens’ Health Insurance Program
(SCHIP), a joint federal-state programme
to expand healthcare coverage (including
prescription drug coverage) for qualifying
children, is poised to be one of the first
healthcare reform proposals debated in
the 111th Congress. A sustained focus on
containing prescription drug costs is also
likely, which could include proposals to allow
the government to negotiate Medicare Part D
prices directly with the pharmaceutical industry,
increase manufacturers’ Medicaid drug rebate
payments under the Medicaid drug rebate
statute, and/or expand Medicaid rebates
for patients who qualify for both Medicaid
and Medicare (so-called ‘dual eligibles’).
Additionally, there could be efforts to pass
legislation implementing comparative
effectiveness research requirements and/or
legislation allowing for the commercial
importation of drugs into the US from selected
countries by certain individual consumers,
pharmacies and drug wholesalers. Finally,
proposals that would require disclosure
of payments to healthcare professionals
(eg for speaker contracts) are also being
considered at the state and federal levels.
In its third year of operation, the Medicare
Part D prescription drug programme
maintained high levels of enrollment and
beneficiary satisfaction, achieved prescription
volume growth similar to other mature markets
and provided access to our medicines for
a large segment of the patient population.
Through the AZ&Me Prescription Savings
Programme for Patients with Medicare Part
D, AstraZeneca provides prescription access
to financially needy Medicare D beneficiaries.
Although difficult to quantify, Medicare Part D
has had an indirect effect on pricing in the
broader US market. Despite the pricing
challenges, overall access in key accounts
was maintained or improved in 2008. It is
difficult to predict fully the longer-term effects
of this initiative on our business.
We continue to support My Medicare Matters,
a community based outreach and education
programme, in partnership with the National
Council on Aging. Funding from AstraZeneca
also supports MyMedicareCommunity.org,
an on-line community for grass roots
organisations serving people with Medicare.
During 2007 and 2008, we supported a pilot
grant programme focused on testing new
approaches to finding and enrolling eligible
people in the Medicare’s Low-Income
Subsidy (LIS) programme. Over 40,000 LIS
applications were submitted as a result of
these demonstration projects.
DIRECtORs’ REPORt
51
ASTRAZENECA ANNUAL REPORT AND FORM 20-F INFORMATION 2008
patent settlement agreements and other
agreements; interventions before national
regulatory authorities; and life-cycle
management strategies.
A final report is expected in Spring 2009.
AstraZeneca has been co-operating fully
with the Commission and participating in
European Federation for Pharmaceutical
Industries and Associations activities.
JAPAN
In Japan, we were the fifth fastest-growing
company amongst the top 15 pharmaceutical
companies, maintaining our market ranking
of number 12 in 2008. Strong volume
growth from key products offset the biennial
government review of downward drug prices
to deliver sales up 4% (+18% reported)
to $1,957 million (2007: $1,661 million).
The key drivers of growth being the continued
success of Crestor (+93%, +118% reported),
the continued growth of Losec (+5%, +18%
reported) and the increased penetration of
Seroquel (+10%, +24% reported).
In Japan, there is formal central government
control of prices by the Ministry of Health,
Labour and Welfare (MHLW) and the
pricing and reimbursement system has
remained largely stable in the last few years.
As expected, pharmaceuticals were subject
to price reductions in April 2008. The long-term
objective of the Japanese government is to
raise generic volume share from 18.7% in
2007 to 30% by 2012; recent reforms have
supported this goal by making substitution of
a generic product for a branded product easier.
In 2008, the MHLW continued their push
towards the acceptance of non-Japanese
Asian data as part of the regulatory approval
package for Japanese patients. Despite
increasing budgetary pressures associated
with an ageing population, they also
publicly recognised the importance of the
pharmaceutical industry and their own drive
to reward innovation better in the future.
OTHER ESTABLISHED REST OF WORLD
In Australia and New Zealand, we delivered
a strong sales performance with sales up
by 15% (+18% reported) to $843 million
(2007: $715 million). Both our primary care
and specialist care portfolios continued
to grow, driven mainly by sales growth for
Crestor, Atacand and Nexium in primary care
and by Seroquel and Arimidex in specialist
care. On a CER basis, these five brands,
Arimidex, Crestor, Seroquel, Atacand and
Nexium, grew by 33% (+37% reported).
Synagis sales outside the US are undertaken
through a subsidiary of Abbott Laboratories
with revenue of $307 million ($169 million in
the seven months from June to December
2007). We estimate that about 36% of sales
arise in Western Europe, about 32% in Japan
and over 7% in Canada. Strong growth has
been recorded in Latin America in 2008.
Most governments in Europe directly intervene
to control the price and reimbursement of
medicines. The decision-making power of
prescribers in Europe has been eroded in
favour of a diverse range of payers. While the
systems to control pharmaceutical spending
vary, they all have had a noticeable negative
impact on the uptake and availability of
innovative medicines. Several governments
have imposed price reductions and increased
the use of generic medicines as part of
healthcare expenditure control. Several
countries are applying strict tests of cost-
effectiveness of medicines, which has reduced
access of European patients to medicines in
areas of high unmet need. These and other
measures all contribute to an increasingly tough
environment for branded pharmaceuticals
in Europe. However, the anticipated radical
change in the UK pharmaceutical system
towards direct government control of prices
was abandoned. Parallel trading of branded
pharmaceuticals continues to challenge the
European pharmaceutical market; a report
commissioned for the EU Commission
acknowledged this and also highlighted
the negative impact of parallel trading on
patient safety.
In January 2008 AstraZeneca, together with
several other companies, was the subject
of an unannounced inspection simultaneous
with the launch by the EU Commission
(Commission) of a Sectoral Inquiry (Inquiry)
into the pharmaceutical industry. The Inquiry
relates to the introduction of innovative and
generic medicines and covers commercial and
other practices, including the use of patents.
On 28 November 2008 the Commission
published its preliminary report. The report does
not identify wrongdoing by any individual
companies but is stated to provide a factual
basis for further consideration. The Commission
has stated that it will commence individual
investigations where there are indications
that competition rules have been breached.
The preliminary report focuses on a number
of issues relating to competition in the EU,
referring to strategies which the Commission
believes pharmaceutical companies use to
block or delay generic entry. Such strategies
include: patent filings and enforcement;
We have continued with our programme of
resource management in Western Europe
and reduced costs by $159 million and
headcount by 618 during 2008.
Overall our sales in France were down 1%
(+7% reported) to $1,922 million (2007:
$1,794 million). The strong performance of
Crestor and Nexium, which gained significant
market share from competitors, was offset by
the loss of patent/marketing exclusivity expiry
for Casodex.
In Germany, sales were down 2% (+6%
reported) to $1,307 million (2007:
$1,233 million), mainly due to the Casodex
patent/marketing exclusivity expiry and the
government restriction on access to Nexium
leading to a reduction in sales of 34% over
last year. Seroquel continued to grow well with
27% growth (+38% reported) reaching 29.5%
of the market for atypical anti-psychotics.
In the UK, sales were up 8% (+2% reported)
to $1,020 million (2007: $1,004 million) driven
by Symbicort (+34%, +25% reported),
Seroquel (+32%, +22% reported), and
Arimidex (+8%, +1% reported). Many of
our other brands also performed well with
Merrem (+13%, +6% reported) being of
particular note. Competition remained intense
but our key brands gained market share in
their respective segments. Especially strong
were Seroquel and Symbicort achieving gains
of 2.4 and 1.3 percentage points respectively.
The UK Government and pharmaceutical
industry have entered into ‘terms of reference’
discussions concerning potential changes
to the pricing and reimbursement scheme.
The impact of these changes is likely to be
$90 million in 2009.
In Italy, Crestor performed strongly increasing its
sales by 12% (+22% reported). The specialty
care brands also showed good growth with
Seroquel increasing sales by 19% (+28%
reported) with 32.9% of the market for atypical
anti-psychotics and Arimidex increasing sales
by 12% (+21% reported) with 32.0% of the
market for aromatase inhibitors and tamoxifen.
However, overall sales declined by 6% (+2%
reported) to $1,323 million (2007: $1,294
million) as a result of reference pricing at the
regional level on PPIs and measures to control
their prescribing by physicians, combined with
Casodex patent/marketing exclusivity expiry.
In Spain, sales were down 8% (-1% reported)
to $863 million (2007: $868 million) due to
Symbicort (-7%, +1% reported) and generic
competition for Casodex and Arimidex.
52
ASTRAZENECA ANNUAL REPORT AND FORM 20-F INFORMATION 2008
EMERGING ASIA PACIFIC
In the rest of the Emerging Asia Pacific region,
overall sales were up 10% (+7% reported) to
$802 million (2007: $749 million) by achieving
strong growth in India, Indonesia, Singapore,
Thailand and Vietnam, where market dynamics
continue to be positive.
LATIN AMERICA
Latin America enjoyed strong sales
performance up 18% (+22% reported) to
$1,159 million (2007: $947 million), mainly
driven by Mexico, Brazil, Venezuela, Central
America and the Caribbean. As a result, our
market share grew to 3% in the prescription
market, improving our position from tenth to
eighth in the prescription market ranking.
This reflects the investment made to develop
our key products in fast-growing markets.
Atacand, Crestor, Nexium, Seroquel and
Symbicort all showed strong performance
with overall sales up 33% (+38% reported) to
$516 million (2007: $372 million). Nexium is
our best selling prescription product in Latin
America with overall sales up 25% (+28%
reported) to $185 million (2007: $144 million)
and thefth best selling prescription product
in the Latin American market. Crestor is now
our second best selling prescription product
with overall sales up 46% (+52% reported)
to $128 million (2007: $84 million) and is the
eleventh best selling prescription product in
the Latin American market.
Our top three largest markets in the region are
now Brazil, Mexico and Venezuela. Brazil sales
were up 21% (+33% reported) to $440 million
(2007: $330 million), Mexico sales were up
6% (+6% reported) to $353 million (2007:
$334 million) and Venezuela sales were up
37% (+37% reported) to $142 million (2007:
$103 million).
MIDDLE EAST AND AFRICA
In 2008, the region again delivered a very
strong double-digit growth, driven mainly by
Atacand, Crestor, Seroquel and Symbicort,
with particularly good performances in Gulf
States, Levant, Egypt, South Africa and
Maghreb. We have recently established
a new marketing company in Israel as part
of our investment plan in the region.
EMERGING REST OF WORLD
In the Emerging Rest of World regions,
sales increased 16% (+20% reported) to
$4,273 million for the full year (2007:
$3,557 million), accounting for nearly 63%
of total sales growth outside the US. Sales in
Emerging Europe were up 10% (+18%
reported) to $1,215 million (2007: $1,028
million). Sales in China increased 31% (+43%
reported) to $627 million (2007: $437 million)
and sales in Emerging Asia Pacific increased
10% (+7% reported) to $802 million (2007:
$749 million).
As the pharmaceutical markets in Asia Pacific,
Latin America and elsewhere develop, reforms
in pricing and reimbursement will inevitably
follow. As these markets become more
important to our business, we have to consider
carefully such factors when we develop
brands. In many of the major markets, such
as China, Brazil and Mexico, the patient pays
directly for prescription medicines, and this
will be an increasingly important issue for our
business. Other growing markets, such as
South Korea and Turkey are seeing more
direct government intervention in pricing and
reimbursement, more in line with the systems
in Europe, Canada and Australia.
EMERGING EUROPE
Russia continued to enjoy strong sales growth
driven by Symbicort, Merrem and Crestor in
2008. Our business in Romania performed
particularly well, almost doubling its size,
primarily driven by Seroquel, Nexium and
Crestor. Our continued expansion included
the establishment of a local marketing
presence in Ukraine and Kazakhstan.
CHINA
In China, in line with our growth and expansion
strategy of the past four years, we have
continued to build our presence and sales
(including Hong Kong) were up 31% (+43%
reported) to $627 million (2007: $437 million).
We are the largest multinational pharmaceutical
company in the prescription market in China,
as surveyed by the Hong Kong Association
of the Pharmaceutical Industry, with a growth
rate for prescription sales of 28.8% (+40.2%
reported). Our investment in China increased
with further growth in the number of sales
representatives, and continued to support
our innovation discovery research centre
in Shanghai and our several external
collaborations, including a new clinical
pharmacology unit in Peking University
and a translational science laboratory in
Guangdong Province People’s Hospital.
08
07
06
6,963
6,686
6,118
CARDIOVASCULAR
0%
+5%
+15%
GROWTH
08
07
06
6,344
6,443
6,631
GASTROINTESTINAL
-4%
-6%
+4%
GROWTH
08
07
06
2,451
1,714
875
INFECTION AND OTHER
1
+41%
+89%
+4%
GROWTH
08
07
06
5,837
5,340
4,704
NEUROSCIENCE
+6%
+10%
+16%
GROWTH
08
07
06
4,954
4,819
4,262
ONCOLOGY
-2%
+8%
+12%
GROWTH
08
07
06
4,128
3,711
3,151
RESPIRATORY & INFLAMMATION
+7%
+12%
+10%
GROWTH
CARDIOVASCULAR GASTROINTESTINAL INFECTION NEUROSCIENCE ONCOLOGY
RESPIRATO RY &
INFLAMMATION
NO CHANGE ADDITION
PROGRESSION
NEW FILING
Recentin
AZD8931
AZD6244
(ARRY-142886)
1
AZD7762 AZD0837
AZD8330
(ARRY-424704)
1
AZD1305 AZD2281 Atacand Seroquel
AZD6370 AZD0530 Atacand Plus Seroquel
AZD6482 CAT-8015 AZD1656 AZD4877 Crestor Seroquel XR
AZD4017 MEDI-538
1
AZD3355 AZD1152
Onglyza
/Metformin
FDC
1
Seroquel XR
AZD2066 AZD8055 CytoFab
™1
AZD9056 Onglyza
™1
Seroquel XR
AZD1386 AZD5904 AZD6918 EBV vaccine
1
AZD5672 Brilinta (AZD6140)
Dapagliflozin/
Metformin FDC
1
Seroquel XR
MEDI-534 AZD3241 AZD4769 AZD7295 AZD1981 Crestor /Trilipix
™1
Iressa
MEDI-560
AZD2066
Pneumococcal
vaccine
1
AZD3480
1
MEDI-528 Dapagliflozin
1
Nexium Zactima
3
MEDI-566
AZD6280 AZD6765 CAT-354 Motavizumab
Nexium Low
Dose Aspirin
Combination
Faslodex
AZD9639
(MEDI-564)
1
TC-5619
1
CAM-3001 AZD1940 AZD9668 PN-400
1
Faslodex
AZD8529 AZD8848 AZD1386 AZD1236 Zactima Symbicort pMDI
CMV vaccine AZD2516 AZD8566 AZD2624 AZD3199 Recentin Nexium Symbicort pMDI
MEDI-557 AZD1446 AZD8075 AZD2327 MEDI-563 Recentin
2
FluMist
Unit Dose
Budesonide
1
MEDI-559 AZD7268 AZD5985 AZD7325 MEDI-545 ZD4054 Motavizumab
PHASE I PHASE II PHASE III/REGISTRATION LIFE-CYCLE MANAGEMENT
DIRECtORs’ REPORt
53
ASTRAZENECA ANNUAL REPORT AND FORM 20-F INFORMATION 2008
This section contains further information
about the therapy areas on which our efforts
are focused: Cardiovascular, Gastrointestinal,
Infection, Neuroscience, Oncology, and
Respiratory and Inflammation. We describe
the business environment, trends and other
factors that have influenced our decision
to focus on diseases in these six areas,
our strategic objectives for each and our
progress towards achieving these objectives.
We include information about our marketed
medicines and how they are designed to
make a meaningful difference for patients,
together with an overview of performance
during the year. We also report in detail
on the potential new products and product
life-cycle developments in our pipeline that
reflect our commitment to maintaining
a flow of innovation that adds value for our
shareholders and society.
Detailed information about relevant continuing
litigation can be found in Note 25 to the
Financial Statements from page 144.
tHERAPY AREA REVIEW
1
Partnered product.
2
Orphan indication.
3
Moved from NCE to Life-cycle management portfolio.
SALES BY THERAPY AREA ($ MILLION)
PIPELINE BY THERAPY AREA
1
Includes Synagis and FluMist which were acquired
in June 2007.
$ BILLION
51.7 HIGH BLOOD PRESSURE
34.9 ABNORMAL LEVELS OF
BLOOD CHOLESTEROL
26.1 DIABETES
21.8 THROMBOSIS
20.9 OTHER
CV is the single largest therapy area in the global
healthcare market. World market value of $155 billion.
CV disease remains the greatest risk to life for most adults,
accounting for 17 million deaths worldwide each year. In the
US, 21 million people suffer from diabetes and two in five
people with diabetes still have poor cholesterol control, one in
three have poor blood pressure and one in five have poor
glucose control.
54
ASTRAZENECA ANNUAL REPORT AND FORM 20-F INFORMATION 2008
CARDIOVAsCULAR
2008 IN BRIEF
Crestor > sales up 26% to $3.6 billion and
Crestor is now approved in every EU country.
Crestor > study demonstrates significant reduction
in major cardiovascular events (44% compared
to placebo in men and women with elevated
hsCRP but low/normal cholesterol levels).
Atacand > sales up 10% to $1.5 billion.
Worldwide collaboration with Bristol-Myers >
Squibb to develop and commercialise
dapagliflozin expanded to include Japan.
US submission for fixed dose combination of >
Crestor and Abbott’s Trilipix
, for the treatment
of mixed dyslypidaemia, anticipated for third
quarter 2009.
Toprol-XL > US sales down 70% for the full year.
OUR MARKETED PRODUCTS
Crestor
1
(rosuvastatin calcium) is a statin for the
treatment of dyslipidaemia and hypercholesterolemia,
and to slow the progression of atherosclerosis.
Atacand
2
(candesartan cilexetil) is an angiotensin II
antagonist for the first-line treatment of hypertension
and symptomatic heart failure.
Seloken/Toprol-XL (metoprolol succinate) is a once
daily tablet for 24-hour control of hypertension and
for use in heart failure and angina.
Tenormin (atenolol) is a cardioselective beta-
blocker for hypertension, angina pectoris and
other cardiovascular disorders.
Zestril
3
(lisinopril dihydrate), an ACE inhibitor, is used
for the treatment of a wide range of cardiovascular
diseases, including hypertension.
Plendil (felodipine) is a calcium antagonist for the
treatment of hypertension and angina.
1
Licensed from Shionogi & Co. Ltd.
2
Licensed from Takeda Chemicals Industries Ltd.
3
Licensed from Merck & Co., Inc.
OUR STRATEGIC OBJECTIVE
Backed by over 40 years’ experience,
AstraZeneca is a world leader in cardiovascular
(CV) medicines. We aim to build on our
strong position, focusing on the growth areas
of atherosclerosis (hardening of the arteries),
thrombosis (blood clotting), diabetes and
atrial fibrillation.
HYPERTENSION, ATHEROSCLEROSIS
AND DYSLIPIDAEMIA
High blood pressure (hypertension) and
abnormal levels of blood cholesterol
(dyslipidaemia) are well known to damage the
arterial wall and thereby lead to atherosclerosis.
CV events driven by atherosclerotic disease
remain the leading cause of death in the
western world. Lipid-modifying therapy,
primarily statins, is a cornerstone of treating
atherosclerotic risk. Within the lipid-modifying
market, generics are taking a significant share
of the market and it is anticipated that generic
atorvastatin will be available late 2011. Recent
studies of some competitor products created
uncertainty about clinical efficacy leading
to reduced sales of these products, whilst
AstraZeneca’s study (see below) provided
positive data on the effect of rosuvastatin.
OUR FOCUS
Our key marketed products
Since its launch in 2003, our statin, Crestor,
has continued to gain market share, based on
its differentiated profile in managing cholesterol
levels and its unique recent label indication
for treating atherosclerotic disease. Following
new approvals during 2008 in Germany,
Spain, Poland, Norway and Malta, Crestor
is now approved in every EU country.
Less than half of the people thought to
have high levels of low-density lipoprotein
cholesterol (LDL-C) ‘bad cholesterol’ get
diagnosed and treated and of those people,
only about half reach their physicians
recommended cholesterol target using existing
treatments. Crestor is the most effective statin
in lowering LDL-C and the majority of patients
reach their LDL-C goals using the usual 10mg
starting dose. Crestor also produces an
increase in high-density lipoprotein cholesterol
(HDL-C) ‘good cholesterol’, across a range
of doses. At its usual 10mg starting dose,
Crestor has been shown, versus placebo,
to reduce LDL-C by up to 52% and raise
HDL-C by up to 14% with eight out of 10
patients reaching their lipid goals.
In the US, Crestor is also approved for use as
an adjunct to diet for slowing the progression
of atherosclerosis in patients with elevated
cholesterol. Crestor is the only statin with an
atherosclerosis indication in the US which is
not limited by disease severity or restricted to
patients with coronary heart disease.
Atacand, first launched in 1997, is approved
for the treatment of hypertension in over 100
countries and for symptomatic heart failure in
over 70 countries. Angiotensin II antagonists
are the fastest growing sector of the global
hypertension market. Available as a once
a day tablet, launches of the 32mg dosage
strength outside the US continued during
the year, and this dosage is now available
in most Established Markets. In July 2008,
we sought approval in Europe for two dose
strengths of Atacand Plus (candesartan
cilexetil/hydrochlorothiazide) which is a fixed
combination of Atacand and the diuretic
hydrochlorothiazide (HCTZ), indicated for
the treatment of hypertension in patients
who need more than monotherapy.
Clinical trial developments
GALAXY, our long-term global clinical research
programme for Crestor investigating links
between optimal lipid control, atherosclerosis
and CV morbidity and mortality, has completed
a number of studies involving over 69,000
patients in over 55 countries.
Data from the latest study, JUPITER, published
in November 2008, demonstrated that
Crestor 20mg significantly reduced major CV
events (defined in this study as the combined
risk of myocardial infarction, stroke, arterial
revascularisation, hospitalisation for unstable
angina, or death from CV causes) by 44%
compared to placebo among men and women
with elevated high-sensitivity C-reactive protein
(hsCRP) (and other risk factors) but low to
normal cholesterol levels. Results also showed
that for patients taking Crestor, the combined
risk of heart attack, stroke or CV death was
reduced by nearly half, risk of heart attack
was cut by more than half, risk of stroke
was cut by nearly half and total mortality was
significantly reduced by 20%. Crestor 20mg
was well tolerated in nearly 9,000 patients
during the course of the study. There was no
difference between treatment groups for major
adverse events, including cancer or myopathy.
There was a small increase in physician
reported diabetes consistent with data from
other large placebo controlled statin trials.
GISSI-HF, an investigator sponsored study
published in September 2008, evaluated
Crestor 10mg and placebo in a heart failure
population and confirmed the results of our
CORONA study in showing no difference
between the treatments in the primary
endpoints of death or CV hospitalisation in
patients with heart failure, over and above
optimised heart failure treatment. Both studies
THERAPY AREA WORLD MARKET (MAT/Q3/08)
DIRECtORs’ REPORt
55
ASTRAZENECA ANNUAL REPORT AND FORM 20-F INFORMATION 2008
were also consistent with the safety profile of
Crestor in this vulnerable population. In both
studies, outcome events appeared to be
driven primarily by heart muscle failure rather
than ischemic events where statins would be
expected to have an effect.
Ongoing studies of Crestor include SATURN,
which is designed to measure the impact
of Crestor 40mg and atorvastatin (Lipitor
)
80mg on the progression of atherosclerosis
in high-risk patients and is expected to report
in 2011. AURORA, an outcomes study in
patients with end stage renal disease is
expected to present data by mid 2009.
The clinical programme (DIRECT) investigating
the effect of Atacand (up to 32mg dosage) on
retinopathy in hypertensive and normotensive
diabetic patients completed in 2008 but failed
to meet the primary endpoint. The results
were published in September 2008.
In the pipeline
We continue the search for the next major
therapy to reduce atherosclerotic risk.
In collaboration with Abbott, we are developing
a fixed dose combination of Crestor and
Abbott’s Trilipix
and are anticipating a US
submission in the third quarter of 2009.
The combination of Crestor (a statin) and
Trilipix
(a fibrate) is a potential new approach
to helping patients with mixed dyslipidaemia
achieve their treatment goals using a single
capsule targeting all three major blood lipids:
LDL-C, HDL-C, and triglycerides. Study
results presented in 2008 showed that the
combination of Crestor and Trilipix
provides
greater benefit across multiple lipid parameters
than monotherapy, with significantly improved
HDL-C and triglycerides compared to statin
therapy alone, and significantly improved
LDL-C compared to Trilipix
alone.
We have stopped work on cholesterol
absorption inhibitors because of failure
to meet target product profiles.
DIABETES
The number of people affected by Type 2
diabetes continues to grow, driven by obesity
in western markets. Type 2 diabetes is a
chronic progressive disease and patients
often require multiple medications to control
their condition. There are a number of
established oral generic and branded classes,
such as sulfonylureas and thiazolidinediones
(TZDs), however, newer classes, such as
oral dipeptidyl peptidase-IV (DPP-IV) are
entering the market successfully by offering
effective blood sugar control and improved
tolerability. Several new classes of drugs
are in development in this area. The safety
of anti-diabetic drugs continues to be an
important focus of regulatory agencies and
additional patient safety requirements for
new medicines can be anticipated.
OUR FOCUS
In 2007, AstraZeneca and Bristol-Myers Squibb
(BMS) announced the collaboration on a
worldwide basis excluding Japan to develop
and commercialise two compounds discovered
by BMS (saxagliptin and dapagliflozin) being
studied for the treatment of Type 2 diabetes.
The development and commercial strategy
for the two compounds is agreed jointly
with BMS. In December 2008, AstraZeneca
and BMS announced the extension of their
collaboration to include dapagliflozin in Japan.
During 2008, AstraZeneca and BMS submitted
a New Drug Application to the FDA and
received the validation of a Marketing
Authorisation Application to the European
Medicines Agency for saxagliptin (Onglyza
).
Onglyza
was specifically designed to be
a selective inhibitor with extended binding
to the DPP-IV enzyme, with dual routes of
clearance. Phase III data published during
2007 and 2008 showed improved glycaemic
control when assessed as a monotherapy,
as well as when assessed in combination
with metformin, sulfonylureas and TZDs.
Dapagliflozin is a potential oral anti-diabetic
belonging to the novel class of sodium-
glucose cotransporter 2 (SGLT2) inhibitors.
It is selective and designed to be used both as
monotherapy and in combination with other
therapies for Type 2 diabetes. Phase IIb data
demonstrated that, when compared with a
placebo, 12 weeks treatment with dapagliflozin
improved blood glucose parameters, resulted
in weight loss and was well tolerated in patients
with Type 2 diabetes. An extensive Phase III
programme is ongoing.
Our activities in the GKA (glucokinase
activator) area continued during 2008,
and clinical studies in Phase II are ongoing.
The GKA mechanism of action induces
insulin release from the pancreas and reduces
glucose output from the liver, with marked
blood glucose reducing effects in situations
of hyperglycaemia.
We also progressed our AZD4017 (11-ßHDS
inhibitor) project into early clinical testing
which aims to increase insulin sensitivity
and thereby induce better glycaemic control
with potential beneficial effects also on body
weight and blood lipids.
We have stopped work on cannabinoid
receptor 1 inhibitors because the
tolerability profile of these inhibitors was
considered unacceptable.
In July 2008, AstraZeneca and Columbia
University Medical Center announced a
strategic research collaboration to develop
novel therapeutics for Type 2 diabetes and
obesity. The research will focus on discovering
mechanisms and identifying new biological
targets for successful and commercially
viable treatments for these diseases.
OUR FINANCIAL PERFORMANCE
2008 2007 2006 2008 compared to 2007 2007 compared to 2006
Growth due Growth due
CER to exchange CER to exchange CER Reported CER Reported
Sales growth effect Sales growth effect Sales growth growth growth growth
$m $m $m $m $m $m $m % % % %
Seloken/Toprol-XL 807 (667) 36 1,438 (393) 36 1,795 (46) (44) (22) (20)
Crestor 3,597 714 87 2,796 673 95 2,028 26 29 33 38
Atacand 1,471 123 61 1,287 99 78 1,110 10 14 9 16
Plendil 268 (18) 15 271 (20) 16 275 (7) (1) (7) (1)
Tenormin 313 (17) 22 308 (24) 12 320 (6) 2 (8) (4)
Zestril 236 (72) 13 295 (30) 18 307 (24) (20) (10) (4)
Other 271 (34) 14 291 (14) 22 283 (12) (7) (5) 2
Total 6,963 29 248 6,686 291 277 6,118 4 5 9
56
ASTRAZENECA ANNUAL REPORT AND FORM 20-F INFORMATION 2008
Toprol-XL and authorised generic sales of the
drug in the US were down 70% for the full
year to $295 million. For the full year, Seloken
sales in the Rest of World were up 1% to
$512 million.
US sales for Atacand for the full year increased
1% to $262 million. Sales in other markets
were up 12% to $1,209 million, on a 10%
increase in Established Markets and an 18%
increase in Emerging Markets.
PERFORMANCE 2007
Reported performance
CV sales rose by 9% from $6,118 million in
2006 to $6,686 million in 2007. Continued
strong growth from Crestor more than offset
the significant declines in Seloken/Toprol-XL.
Performance – CER growth rates
CV sales grew by 5% at CER. Crestor sales
increased by 33% to $2,796 million. In the
US, Crestor sales for the full year were
$1,424 million, a 24% increase over 2006.
Total prescriptions in the US statin market
increased 8% for the year; Crestor prescriptions
were up 22%. Sales outside the US for the
full year increased 45% to $1,372 million,
nearly half the total worldwide sales for the
product. Sales were up 26% in Western
Europe with good growth in France and Italy.
Sales in Canada increased 43%.
Global sales of Seloken/Toprol-XL fell by 22%
to $1,438 million. US sales of the Toprol-XL
product range, which includes sales of the
authorised generic were down 30% for the
full year, as the full range of dosage strengths
were subject to generic competition from
August 2007. Sales of Seloken in other markets
were up 5% for the full year as a result of
growth in Emerging Markets.
Atacand sales in the US were unchanged
for the full year whilst sales in other markets
increased 12%.
Continued small declines were seen in Zestril
(down 10% to $295 million) and Plendil (down
7% to $271 million), with general global falls
compensated by increases in discrete markets.
FURTHER INFORMATION
In December 2007, we filed patent
infringement actions against seven generic
drug manufacturers in the US following
receipt of notices of their intent to market
generic copies of Crestor before the 2016
expiry of our licensed patent covering the
active ingredient in Crestor. In July 2008,
we filed a patent infringement action against
Teva Pharmaceuticals in the US following
receipt of its notice of its intent to market
generic copies of Crestor before the 2016
expiry of our licensed patent covering the
active ingredient in Crestor. These eight cases
are proceeding as a consolidated action in
US District Court, District of Delaware.
Also in the US, Teva Pharmaceuticals
(Teva’s Israeli parent company) filed a patent
infringement lawsuit concerning Crestor on
6 October 2008. Teva alleges that Crestor
tablets infringe a recently re-issued Teva US
patent that claims stabilised pharmaceutical
compounds.
AstraZeneca has full confidence in its Crestor
product and the intellectual property protecting
it, and will vigorously defend and enforce it.
Further information is set out in Note 25 to
the Financial Statements on page 148.
FINANCIAL PERFORMANCE 2008/2007
PERFORMANCE 2008
Reported performance
CV sales were up 4% as reported to
$6,963 million (2007: $6,686 million). Strong
growth from Crestor, fuelled by the promotion
of the atherosclerosis indication and increased
sales of Atacand offset the continuing
significant declines in Seloken/Toprol-XL.
Performance – CER growth rates
CV sales were unchanged from 2007
at CER. Crestor sales increased by 26%
to $3,597 million. US sales for Crestor for the
full year increased by 18% to $1,678 million.
Crestor total prescription share in the US
statin market increased to 9.9% in December
2008 from 8.6% in December 2007, and was
the only branded statin to gain market share.
Crestor sales in the Rest of World were up
34% for the full year to $1,919 million, over half
of global sales for the product. Sales were up
16% in Western Europe to $836 million and
93% in Japan driving sales growth in the
Established Markets and the Rest of World
up 33% in total. Sales in Emerging Markets
increased by 41%.
ARRHYTHMIA AND THROMBOSIS
Atrial fibrillation (AF) is the most common
cardiac arrhythmia. Rhythm-control therapy
to control the symptoms of AF is dominated
by generic amiodarone, which is effective at
maintaining patients in normal heart rhythm,
but very poorly tolerated. There remains an
unmet need for a safe and tolerated therapy
with effective symptom relief. Two competitor
products are in late development for use in AF
and recent data from an outcome study of one
of them versus placebo in AF patients showed
clinical benefit in addition to symptom relief
– the first time for an anti-arrhythmic agent.
Patients surviving an acute coronary event
are at increased risk from further thrombosis
and treatment guidelines advocate anti-platelet
therapy. New guidelines issued in 2007 by
the European Society of Cardiology for the
treatment of acute coronary syndrome (ACS),
have highlighted the negative consequences
of drug induced bleeding in conjunction with
the treatment of ACS, reinforcing the need for
new anti-thrombosis drugs with acceptable
bleeding risk.
During the year, two new anti-coagulants
(dabigatran and rivaroxaban) were approved
in Europe for use in prevention of deep vein
thrombosis in conjunction with orthopaedic
surgery. No Phase III data are yet available for
the ability of new anti-coagulants to prevent
strokes in AF, the major chronic indication
for anti-coagulants, without the risks and
repeated monitoring of warfarin or other
vitamin K antagonists.
OUR FOCUS
In the pipeline
Brilinta (ticagrelor AZD6140), the first reversible,
oral, adenosine diphosphate (ADP) receptor
antagonist, is being developed to reduce
the risk of blood clots and thrombotic events
in patients diagnosed with ACS. Ticagrelor
is currently being studied in the Phase III
PLATO clinical trial, involving over 18,000
ACS patients in 43 countries, to determine
if it is superior to clopidogrel for reducing the
risk of thrombotic events in ACS patients.
The effectiveness of AZD0837 (an oral, direct
thrombin inhibitor) in preventing strokes and
other embolic events in AF patients will be
studied in more than 35 countries, using
a once-daily extended release formulation that
provides sustained anti-coagulation effect
throughout the dosing interval. We anticipate
starting these Phase III studies in 2009.
Our lead compound in the treatment of AF is
AZD1305, a combined ion channel blocker,
which has progressed into Phase IIa testing
in both the IV and oral form.
$ BILLION
26.0 PPI
13.0 OTHER
The GI world market is valued at $39 billion, with the
proton pump inhibitor market accounting for $26 billion.
In the West (ie Europe and North America combined),
according to different estimates, between 10% and 20%
of adults suffer from GERD. The prevalence of GERD in Asia
is lower but increasing. In spite of effective treatments with
PPIs, around 40% of patients do not achieve full relief
from symptoms.
DIRECtORs’ REPORt
57
ASTRAZENECA ANNUAL REPORT AND FORM 20-F INFORMATION 2008
GAstROINtEstINAL
2008 IN BRIEF
Sales of > Nexium $5.2 billion, down 2%.
Nexium > submissions in the EU for the short-term
maintenance of haemostasis and prevention of
re-bleeding in patients with peptic ulcer bleeding
following therapeutic endoscopy and in the US
for use in patients with peptic ulcer bleeding
following therapeutic endoscopy.
In late 2008, a Complete Response Letter >
received from the FDA in connection with our
Nexium submission for peptic ulcer bleeding.
Losec/Prilose > c sales $1.05 billion declining in the
EU and US due to continuous generic pressure
including the recent patent expiry in Italy. Overall
sales down 14%; Japan sales still growing, up 5%.
Settlement of patent litigation in the US brought by >
AstraZeneca against Ranbaxy, with enforceability
of disputed Nexium patents conceded and an
agreement for licensed sales of generic Nexium
from May 2014.
Other patent litigation continuing in the US against >
generic manufacturers following abbreviated new
drug applications relating to Nexium.
OUR MARKETED PRODUCTS
Nexium (esomeprazole) is the first proton pump
inhibitor (PPI) for the treatment of acid-related
diseases to offer clinical improvements over other
PPIs and other treatments.
Losec/Prilosec (omeprazole) is used for the
short-term and long-term treatment of acid-
related diseases.
Entocort (budesonide) is a locally acting
corticosteroid for the treatment of inflammatory
bowel disease (IBD).
OUR STRATEGIC OBJECTIVE
We aim to maintain our strong position in
gastrointestinal (GI) treatments by continuing to
focus on PPIs. New Nexium line extensions
include prevention of re-bleeding in patients
with peptic ulcer bleeding, and prevention
of low dose aspirin associated peptic ulcer.
Our research and development is focused on
finding new, innovative ways for treating acid
reflux related disease.
GASTRO-OESOPHAGEAL
REFLUX DISEASE (GERD)
OUR FOCUS
Our key marketed products
Nexium is an effective, long-term therapy for
patients with GERD. For the treatment of active
peptic ulcer disease, seven-day Nexium triple
therapy (in combination with two antibiotics for
the eradication of H.pylori) heals most patients
without the need for follow-up anti-secretory
therapy. Since it was first launched in 2000,
Nexium has been used in the treatment of
acid-related diseases in over one billion
patient treatments.
Nexium is available in approximately 100
countries for the treatment of acid-related
diseases. In the US and EU, Nexium is also
approved for the treatment of children aged
12 to 17 years with GERD and in 2008 was
approved for use in these countries in children
aged one to 11 years old. Nexium is also
approved in the US, the EU, Canada and
Australia for the treatment of patients with the
rare gastric disorder, Zollinger-Ellison syndrome.
In Europe, Nexium is approved for the healing
and prevention of ulcers associated with
non-steroidal anti-inflammatory drug (NSAID)
therapy including Cox2 inhibitors. In the US,
Nexium is approved for reducing the risk of
gastric ulcers associated with continuous
NSAID therapy in patients at risk of developing
gastric ulcers.
Nexium IV, which is used when oral
administration is not suitable for the treatment
of GERD and upper GI side effects induced
by NSAIDs, is approved in 86 countries
including the US and all EU countries.
During 2008, we announced the submission of
a supplemental new drug application (sNDA)
to the FDA for Nexium IV (esomeprazole
sodium) injection, seeking approval for use in
patients with peptic ulcer bleeding following
therapeutic endoscopy. This was followed
by an EU submission for Nexium IV and
tablets, seeking approval for the short-term
maintenance of haemostasis and prevention
of re-bleeding in patients with peptic ulcer
bleeding following therapeutic endoscopy.
In late November 2008, we received the FDA
Complete Response Letter regarding our
Nexium IV sNDA for peptic ulcer bleed. The
application has not received FDA approval in
its present form. We are reviewing their
comments and will respond in due course.
The EU submission is still being reviewed by
the European regulatory authorities.
Since its launch in 1988, we estimate that
patients have benefited from over 900 million
treatments with Losec/Prilosec. We continue
to maintain patent property covering Losec/
Prilosec. Further information about the
status of omeprazole patents and patent
litigation, including details of generic
omeprazole launches, is set out in Note 25
to the Financial Statements on page 150.
Entocort has better tolerability than other
corticosteroids in inflammatory bowel disease
and greater efficacy than aminosalicylic acid
medicines. It is prescribed as first-line therapy
for both acute treatment and maintenance of
clinical remission of mild to moderate, active
Crohn’s disease and is approved in more
than 40 countries.
Clinical trial developments
Data from the Nexium IV Peptic Ulcer Bleed
study (a multinational, randomised trial of
767 patients with peptic ulcer bleeding) is
the basis for submissions in the US and EU
referred to above. The study shows that use
of Nexium IV for three days, followed by oral
Nexium therapy for 27 days, was statistically
more effective in reducing gastric ulcers
compared to placebo after both three and
30 days.
In the pipeline
Our activities focus on reflux inhibitors and
hypersensitivity therapy. Our lead compound,
AZD3355, is undergoing clinical trials.
Follow-up compounds are in Phase I testing.
Non-GERD related GI projects were
successfully transferred to the spin-out
company Albireo, in which AstraZeneca
holds a large minority stake.
FURTHER INFORMATION
In the US, we are continuing to pursue
patent litigation against various generic
manufacturers who have filed abbreviated
new drug applications (ANDAs) and are
seeking to market esomeprazole magnesium
products before the expiration of certain of
our patents relating to Nexium.
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58
ASTRAZENECA ANNUAL REPORT AND FORM 20-F INFORMATION 2008
PERFORMANCE 2007
Reported performance
GI sales fell by 3% to $6,443 million in 2007
from $6,631 million in the previous year.
Performance – CER growth rates
GI sales fell by 6% at CER. Worldwide,
Nexium sales fell by 2% to $5,216 million.
In the US, Nexium sales for the full year were
$3,383 million, down 4%. Estimated volume
growth was 2% for the year. Nexium market
share in the branded segment of the PPI
market increased by 1.5 percentage points
in 2007; however, generic omeprazole share
of the prescription PPI market increased to
27.4% by December 2007, an increase of
nearly 7 percentage points since December
2006. Realised prices declined by around 8%
for the year. Nexium sales in other markets
were up 2% for the full year to $1,833 million,
as growth in Emerging Markets more than
offset the declines in Western Europe.
For the full year, Losec sales declined by 20%
to $1,143 million. Prilosec sales in the US
were down 3% to $226 million. Losec sales
in other markets were down 24%, although
sales increased in Japan and China; sales in
these two markets accounted for almost
30% of the brand’s performance.
We continue to have full confidence in our
intellectual property protecting Nexium and
will vigorously defend and enforce it.
The decision of the European Court of First
Instance on our appeal against the European
Commissions Decision in 2005 to imposenes
on us totalling €60 million ($75 million) for
alleged infringements of European competition
law relating to certain omeprazole intellectual
property and regulatory rights is still pending.
Further information about this case is set out
in Note 25 to the Financial Statements on
page 151.
In 2008 we filed complaints for patent
infringement against two generic manufacturers
(Barr Laboratories and Mylan Pharmaceuticals)
in response to notices of ANDA submissions
in respect of generic forms of Entocort EC.
FINANCIAL PERFORMANCE 2008/2007
PERFORMANCE 2008
Reported performance
Sales for 2008 were down 2% on a reported
basis to $6,344 million from $6,443 million
in 2007.
Performance – CER growth rates
GI sales fell by 4% at CER. Global Nexium
sales were down 2%, excluding the effects of
exchange, to $5,200 million from $5,216
million the previous year. The decline was
driven by the decrease in the US of 8% to
$3,101 million, however this was largely
mitigated by sales in other markets increasing
by 9% to $2,099 million. In the US, dispensed
retail tablet volumes increased by 2% and
Nexium was the only major PPI brand to
do so in 2008. In the Rest of World, growth
in Canada (9%), Japan (5%) and Emerging
Markets (20%) more than offset the 5%
decline in Western European sales.
For the full year, sales of Losec fell 14% to
$1,055 million. Prilosec sales in the US were
down 25% as a result of generic competition
for the 40mg dosage form in the second half
of the year. In the Rest of World, sales declined
by 11%, despite increases in China (19%)
and Japan (5%).
On 15 April 2008, AstraZeneca announced
it had settled its Nexium patent infringement
litigation against Ranbaxy Pharmaceutical
Industries and affiliates (Ranbaxy). As a
consequence of the settlement, the patent
litigation filed by AstraZeneca following
Ranbaxy’s submission to the FDA of an ANDA
for a generic version of Nexium has been
dismissed. Under the settlement Ranbaxy
concedes that all six patents asserted by
AstraZeneca in the patent litigation are valid
and enforceable. Ranbaxy also accepts that
four of the patents would be infringed by
the unlicensed sale of Ranbaxy’s proposed
generic product. The settlement agreement
allows Ranbaxy to commence sales of a
generic version of Nexium under a licence
from AstraZeneca from 27 May 2014, the
expiry date of US Patent Numbers 5,877,192
and 6,875,872. We are co-operating fully
with the Federal Trade Commission inquiry
regarding this settlement.
AstraZeneca’s Nexium patent infringement
litigation against Teva/IVAX and Dr Reddy’s
Laboratories remains ongoing. No trial date
has been set in either case.
During 2008, we received additional notices
that patent challenges had been filed by
generic drug manufacturers in respect of 20mg
and 40mg delayed-release esomeprazole
magnesium capsules. Details of these filings
and of new and continuing litigation are set
out in Note 25 to the Financial Statements
on page 153.
The European Patent Office ruled in 2007
that the European process patent for Nexium
and the European patent for the multiple unit
pellet (MUPS) formulations of PPI, which expire
in 2015, are valid in amended form following
post-grant oppositions. These decisions are
now subject to appeal proceedings.
Further, the European Patent Office granted a
new European patent on 19 November 2008
for the MUPS formulations of esomeprazole
and omeprazole, which expires in 2015.
OUR FINANCIAL PERFORMANCE
2008 2007 2006 2008 compared to 2007 2007 compared to 2006
Growth due Growth due
CER to exchange CER to exchange CER Reported CER Reported
Sales growth effect Sales growth effect Sales growth growth growth growth
$m $m $m $m $m $m $m % % % %
Nexium 5,200 (121) 105 5,216 (104) 138 5,182 (2) (2) 1
Losec/Prilosec 1,055 (156) 68 1,143 (277) 49 1,371 (14) (8) (20) (17)
Other 89 2 3 84 2 4 78 2 6 3 8
Total 6,344 (275) 176 6,443 (379) 191 6,631 (4) (2) (6) (3)
$ BILLION
35.5 ANTI-BACTERIALS
19.7 ANTI-VIRALS
21.5 OTHERS
The world Infection market is valued at $77 billion, with
anti-bacterials accounting for approximately 46% and
anti-virals for 25%.
World demand for antibiotics remains high, due to escalating
resistance and the increased risk of serious infections in both
immuno-suppressed patients and ageing populations.
Approximately half of all infants are infected with RSV during
the first year of life. Seasonal influenza results in three to five
million cases of severe illness and up to half a million deaths
globally each year.
DIRECtORs’ REPORt
59
ASTRAZENECA ANNUAL REPORT AND FORM 20-F INFORMATION 2008
2008 IN BRIEF
Merrem > sales of $897 million, up 13%.
Strong reported growth for > Merrem of 16%
globally; 39% in the US.
Synagis > sales of $1.23 billion; in the US
$923 million.
Biologics Licence Application submitted for >
motavizumab, an improved anti-respiratory
syncytial virus monoclonal antibody.
A Complete Response Letter subsequently
received from the FDA.
Market authorisation application submitted to >
European Medicines Agency for Live Attenuated
Influenza Vaccine.
OUR MARKETED PRODUCTS
Synagis (palivizumab) is a humanised monoclonal
antibody used for the prevention of serious lower
respiratory tract disease caused by RSV in paediatric
patients at high risk of acquiring RSV disease.
Merrem/Meronem
1
(meropenem) is a carbapenem
anti-bacterial used for the treatment of serious
infections in hospitalised patients.
FluMist (Influenza Virus Vaccine Live, Intranasal)
is a live, attenuated, trivalent influenza virus vaccine
licensed in the US for active immunisation of people
two to 49 years of age against influenza disease
caused by influenza virus subtypes A and type B
contained in the vaccine.
1
Licensed from Dainippon Sumitomo
Pharma Co., Ltd.
OUR STRATEGIC OBJECTIVE
We aim to build a leading franchise in the
treatment of infectious diseases through
continued commercialisation of the in-line
brands such as Synagis, Merrem and FluMist,
effective use of our structural and genomic-
based discovery technologies and antibody
platforms, and through continued research
of novel approaches in areas of unmet
medical need.
RESISTANT BACTERIAL INFECTIONS
World demand for antibiotics remains high,
due to escalating resistance and the increased
risk of serious infections in both immuno-
suppressed patients and ageing populations.
Many bacterial infections currently have few
satisfactory treatment options prompting
demand for new and better therapies.
OUR FOCUS
Our key marketed products
Merrem/Meronem (meropenem) is a
carbapenem antibiotic, which is active
against most bacteria that cause serious
infections in hospitalised patients. Merrem
is the leading carbapenem and has a growing
share of the intravenous antibiotic market
because of its activity against bacteria resistant
to many other agents. To meet the high and
growing need for new and better therapies
for resistant bacterial infections we have built
an anti-bacterials discovery capability that
places AstraZeneca among the industry
leaders with the capability to create novel
mechanism anti-bacterials.
RESPIRATORY SYNCYTIAL VIRUS (RSV)
Approximately half of all infants are infected
with RSV during the first year of life and nearly
all children in the US have been infected by
the time they reach their second birthday.
Unlike other viral infections, there is no
complete and durable immunity created
by RSV, so repeated infection is likely and
common. Premature babies (earlier than 36
weeks gestational age, especially those less
than 32 weeks) or babies with chronic lung
disease or congenital heart disease are at an
even greater risk of contracting severe RSV
disease than full-term babies.
OUR FOCUS
Our key marketed products
Synagis is used for the prevention of serious
lower respiratory tract disease caused by RSV
in children at high risk of the disease. It was
the first monoclonal antibody (MAb) approved
in the US for an infectious disease and since
its launch in 1998 it has become the standard
of care for RSV prevention. Synagis remains
the only immunoprophylaxis in the marketplace
indicated for the prevention of RSV in
paediatric patients at high risk of RSV. Synagis
is administered by intra-muscular injection.
In the pipeline
During 2008, we filed a biological licence
application with the FDA for an improved
anti-RSV MAb, motavizumab. We recently
completed a Phase III study with
motavizumab as a prophylaxis in infants
with haemodynamically significant congenital
heart disease. We are also conducting
a Phase IIb study with motavizumab as a
treatment for children hospitalised with severe
RSV disease. In November 2008 we received
a Complete Response Letter from the
FDA asking for additional information on
motavizumab which we are confident we can
respond to and does not lead us to believe it
is necessary to conduct further clinical trials.
In addition, three intranasal vaccines are
being developed for the prevention of lower
respiratory tract illness caused by RSV and
parainfluenza virus-3 (PIV3): MEDI-559 (RSV),
MEDI-560 (PIV3) and MEDI-534 (RSV-PIV3).
We are conducting several Phase I and
Phase I/II studies for these vaccines alone
and in collaboration with the US National
Institute of Allergy and Infectious Diseases
under a Co-operative Research and
Development Agreement.
INFLUENZA VIRUS
Influenza is the most common vaccine-
preventable disease in the developed world.
According to World Health Organization
estimates, seasonal influenza results in three
to five million cases of severe illness and up
to half a million deaths globally each year,
primarily among the elderly. Rates of infection
are highest among children, with school-aged
children significantly contributing to the spread
of the disease. Influenza also has socio-
economic consequences related to both
direct and indirect healthcare costs, including
hospitalisations, work absence and loss of
work productivity when either a caregiver or
child is sick with influenza.
OUR FOCUS
Our key marketed products
FluMist is the first live, attenuated nasally
delivered vaccine approved in the US for the
prevention of disease caused by influenza A
and B viruses in eligible children and adults,
ages two to 49 years. In 2008, the US Centres
for Disease Control and Prevention’s Advisory
Committee on Immunization Practices voted
to expand recommendations for routine
seasonal influenza vaccination to include all
school-age children up to the age of 18 years
as soon as feasible but no later than the
2009/2010 influenza season. During the year,
INFECtION
THERAPY AREA WORLD MARKET (MAT/Q3/08)
60
ASTRAZENECA ANNUAL REPORT AND FORM 20-F INFORMATION 2008
FluMist sales were $104 million for the full year.
In contrast to 2008, all of 2007 FluMist sales of
$53 million were realised in the fourth quarter
as a result of the timing of regulatory approvals
for the new formulation and expanded label.
PERFORMANCE 2007
Reported performance
Infection sales grew by 96% to $1,714 million
from $875 million in 2006, driven by the
inclusion of seven months of Synagis and
FluMist sales and an increase in Merrem sales
of 28%.
Performance – CER growth rates
Infection sales grew by 89%, after excluding
the effect of exchange. CER growth of 20%
from Merrem, with sales of $773 million, and
the inclusion of Synagis and FluMist were
the principal drivers of this growth. Sales of
Synagis totalled $618 million for the period
post-acquisition of MedImmune, with $480
million arising in the fourth quarter. Synagis
sales are highly seasonal, with the majority of
sales recorded in the fourth and first quarters.
Sales of FluMist were $53 million for the full
year, all of which were recorded in the fourth
quarter. As with Synagis, there were no
corresponding sales in the prior year period.
Sales of Merrem increased by 20% to
$773 million, with strong growth in the US
(sales up 32% to $149 million) and Western
Europe (sales up 20% to $307 million).
TUBERCULOSIS (TB)
TB remains a worldwide threat and is
newly diagnosed in over eight million people
worldwide every year. It is one of the greatest
causes of death from infectious disease in
the developing world.
OUR FOCUS
As part of our commitment to making
a contribution to improving health in the
developing world, we are working to find
a new, improved treatment for TB. We have a
dedicated research facility in Bangalore, India
that is focused on finding a treatment for TB
that will act on drug-resistant strains, simplify
the treatment regime (current regimes are
complex and lengthy, meaning many patients
give up before the infection is fully treated)
and be compatible with HIV/AIDS therapies
(TB and HIV/AIDS form a lethal combination,
each speeding the other’s progress). Over 80
scientists in Bangalore work closely with
our infection research centre in Boston, US
as well as with academic leaders in the field,
and they have full access to all AstraZeneca’s
platform technologies, such as high
throughput screening and compound libraries.
It is a complex area of research, but we hope
to have identified a candidate drug for testing
in man within the next two to three years.
FINANCIAL PERFORMANCE 2008/2007
PERFORMANCE 2008
Reported performance
Total Infection sales increased on a reported
basis by 43% to $2,451 million as a full year
of Synagis and FluMist sales were taken in
the Group for the first time, and Merrem sales
enjoyed another year of good growth.
Performance – CER growth rates
Infection sales were up 41% at CER. For the
full year, Synagis sales were $1,230 million.
Sales in 2007 were $618 million, but this
only reflected sales since the acquisition of
MedImmune in June 2007. Worldwide sales of
Synagis in the fourth quarter were $506 million,
a 5% increase over the same period in 2007
when the product was included in sales.
we began rolling out the international
marketing plan for our nasal spray influenza
vaccine. The first milestone was the filing of
a market authorisation application to the
European Medicines Agency in late 2008.
HEPATITIS C VIRUS (HCV)
HCV infects an estimated 170 million people
worldwide and the current market for HCV
therapy exceeds $2 billion annually. However,
therapy for the strains that predominate in the
US and Western Europe require 12 months’
treatment and produces a durable cure in only
50% of patients. Key opinion leaders expect
the current standard of treatment (interferon
plus ribavirin) to change to a form of
combination therapy involving one or more
new mechanism of action direct-acting
anti-virals and there are several small and large
pharmaceutical companies with varying HCV
pipelines focused on such therapies. A future
paradigm of combinations of anti-virals as
standard care offers the opportunity for
several new therapies to be widely used.
OUR FOCUS
In the pipeline
Projects in development include AZD7295,
a novel HCV compound, currently in Phase II.
SEPSIS
Sepsis is a life-threatening condition resulting
from uncontrolled severe infections, which
affects an estimated three million people
a year worldwide. Few industry pipelines are
focused on the development of products
specifically for registration for the treatment
of sepsis or septic shock.
OUR FOCUS
In the pipeline
The development programme for CytoFab
,
our potential treatment for severe sepsis
licensed from Protherics, continues in Phase II
development. CytoFab
has the potential to
be one of a limited number of medicines
specifically developed for such patients.
OUR FINANCIAL PERFORMANCE
2008 2007 2006 2008 compared to 2007 2007 compared to 2006
Growth due Growth due
CER to exchange CER to exchange CER Reported CER Reported
Sales growth effect Sales growth effect Sales growth growth growth growth
$m $m $m $m $m $m $m % % % %
Merrem 897 97 27 773 121 48 604 13 16 20 28
Synagis
1
1,230 612 618 618 n/m n/m n/m n/m
FluMist
1
104 51 53 53 n/m n/m n/m n/m
Other 220 (54) 4 270 (12) 11 271 (20) (19) (4)
Total 2,451 706 31 1,714 780 59 875 41 43 89 96
1
Acquired in June 2007.
$ BILLION
57.4 PSYCHIATRY
41.6 NEUROLOGY
30.0 ANALGESIA
4.8 ANAESTHESIA
The Neuroscience world market totals $134 billion.
The medical need in Neuroscience is significant. Depression
and anxiety disorders remain under-diagnosed and
under-treated, with 15% of the population suffering from
major depression at least once in their lives. Schizophrenia
affects around 1% of the adult population, and 17 million
people suffer from bipolar disorder across the major markets.
Chronic pain affects over 20% of the population and pain
management is the most common reason for seeking medical
care. Alzheimer’s disease affects approximately 24 million
people worldwide (predicted to reach 40 million by 2020).
Current therapy does not significantly change the course of
this progressive neuro-degenerative disorder.
DIRECtORs’ REPORt
61
ASTRAZENECA ANNUAL REPORT AND FORM 20-F INFORMATION 2008
OUR STRATEGIC OBJECTIVE
We aim to strengthen our position in
neuroscience through further growth of
Seroquel and Seroquel XR and by the
successful introduction of a range of new
medicines aimed at significant medical need
in psychiatry, analgesia (pain control) and
cognition (including Alzheimer’s disease and
cognitive disorders in schizophrenia).
PSYCHIATRY
Most branded schizophrenia products will face
generic competition in the period 2012 to
2015, with all current atypical anti-psychotic
patents expiring by 2018. Future demand will
be for products with significantly improved
efficacy and tolerability.
The depression and anxiety markets are
currently dominated by generic selective
serotonin re-uptake inhibitors and serotonin
norepinephrine re-uptake inhibitors. As growth
in the US slows, the Japanese market continues
to grow. Generic growth is anticipated over
the next five years as patents expire.
OUR FOCUS
Our key marketed products
Seroquel is a leading atypical anti-psychotic
treatment for adult schizophrenia and bipolar
disorder. Seroquel remains the most commonly
prescribed atypical anti-psychotic in the US,
where it is the only atypical anti-psychotic
approved as monotherapy treatment for both
bipolar depression and bipolar mania as well
as the leading atypical brand globally by sales
value. Its clinical development programme
was substantially completed during 2008
resulting in worldwide launches of Seroquel XR
for schizophrenia. We have also made
the associated regulatory submissions and
data presentations in bipolar disorder, major
depressive disorder (MDD) and generalised
anxiety disorder (GAD).
First launched in 1997, Seroquel is now
approved in 92 countries. Seroquel XR,
an extended release formulation that offers
patients and doctors a once-daily treatment,
was launched in the US for the treatment of
schizophrenia in 2007 and is now approved
in 45 countries for schizophrenia, 12 countries
for bipolar mania, seven countries for bipolar
depression and four countries, including the
US, for bipolar maintenance, in one market
for MDD, and in one market for GAD.
In 2008, the FDA approved Seroquel XR
for the treatment of depressive episodes
associated with bipolar disorder, the manic
and mixed episodes associated with bipolar 1
disorder and both Seroquel and Seroquel XR
for the maintenance treatment of bipolar 1
disorder as adjunctive therapy to lithium or
divalproex. In addition, Seroquel XR and
Seroquel were approved in the EU for the
treatment of major depressive episodes in
bipolar disorder. Seroquel XR was also
licensed in the EU for moderate to severe
manic episodes in bipolar disorder.
During 2008, regulatory submissions were
made in both the US and in the EU for
GAD and for MDD. AstraZeneca received
a Complete Response Letter from the FDA
for its sNDA for Seroquel XR for the treatment
of MDD in adult patients. AstraZeneca
is continuing discussions with the FDA.
A separate regulatory submission was made
to the FDA for the treatment of schizophrenia
in adolescents (13 to 17 year olds) and for
the treatment of acute manic episodes in
children and adolescents (10 to 17 year olds)
with bipolar 1 disorder. The US prescribing
information for Seroquel and Seroquel XR
is being updated to include new safety
information regarding use in children and
adolescents. Seroquel and Seroquel XR are
not approved currently for use in paediatric
patients under 18 years of age.
In January 2009, the FDA granted an additional
six-month period of market exclusivity to
Seroquel for its licensed indications, based
on studies we conducted in adolescents with
schizophrenia and children and adolescents
with bipolar mania. The Seroquel patent expires
in September 2011. The allowed six-month
paediatric exclusivity period, which takes
effect upon expiration of the patent, will extend
the exclusivity of Seroquel to March 2012.
In the pipeline
We have progressed AZD8529 into Phase I
and AZD2624 into Phase II for the treatment
of schizophrenia, with AZD2327 entering
Phase Ila and AZD6765 and AZD7325
entering into Phase IIb clinical development
for the treatment of anxiety and/or depression.
We also continued to build our alliance/
partnership network in 2008 by entering into
a collaboration with the Columbia University
Medical Center to examine further the
relevance of adult neurogenesis in anti-
depressant action and novel approaches
to treat depression and anxiety.
NEUROsCIENCE
2008 IN BRIEF
Seroquel > sales up 9% to over $4.45 billion.
Seroquel XR > approved in the US for acute
bipolar depression, acute bipolar mania and
bipolar maintenance.
Seroquel XR > approved under the European Mutual
Recognition Procedure for the treatment of acute
bipolar depression and acute bipolar mania in
October. Seroquel also approved at the same time
for the treatment of acute bipolar depression.
FDA Complete Response Letter received on >
Seroquel XR for Major Depressive Disorder
in December.
Regulatory submissions made for > Seroquel XR
for the treatment of Major Depressive Disorder
and for Generalised Anxiety Disorder in both
the US and EU.
Summary Judgment Motion granted to >
AstraZeneca in the patent infringement
actions commenced against two generic drug
manufacturers in the US following abbreviated
new drug applications relating to Seroquel.
Separate lawsuits filed in the US against third >
party manufacturers relating to infringement
of the Seroquel XR patents.
Personal injury actions in the US and Canada >
involving Seroquel being defended vigorously.
OUR MARKETED PRODUCTS
Seroquel (quetiapine fumarate) is an atypical
anti-psychotic drug approved for the treatment
of adult schizophrenia and bipolar disorder
(mania, depression and maintenance).
Zomig (zolmitriptan) is for the treatment of migraine
with or without aura.
Diprivan (propofol) is an intravenous general
anaesthetic used in the induction and maintenance
of anaesthesia, light sedation for diagnostic
procedures and for intensive care sedation.
Naropin (ropivacaine) is a long-acting local
anaesthetic, replacing the previous standard
treatment of bupivacaine.
Xylocaine (lidocaine) is a widely used short-acting
local anaesthetic.
EMLA (lidocaine + prilocaine) is a local anaesthetic
for topical application.
THERAPY AREA WORLD MARKET (MAT/Q3/08)
62
ASTRAZENECA ANNUAL REPORT AND FORM 20-F INFORMATION 2008
COGNITION
Alzheimer’s disease remains one of the largest
areas of unmet need and also one of high
risk for neuroscience product development,
due in part to the challenges of establishing
efficacy in clinical trials. Current treatments,
which physicians consider inadequate, target
the symptoms not the underlying cause of
the disease. Achieving disease modification
is very difficult evidenced by recent late stage
product development failures. Growth in this
area is strong (20% to 40% across the world)
but all existing agents will face patent expiry
by 2013.
There are currently no products approved to
treat cognitive dysfunction associated with
schizophrenia. The first product to market will
face the challenge of disease education and
the establishment of treatment guidelines.
OUR FOCUS
In the pipeline
We have expanded the portfolio of potential
medicines in this area to five development
programmes, of which three are in clinical
evaluation, in Alzheimer’s disease, cognitive
disorders in schizophrenia (CDS) and other
cognition disorders. In addition to developing
molecules for cognitive disorders, we
continue to progress two development
phase molecules for the treatment of other
neurodegenerative diseases.
Through our collaboration with, amongst
others, the Karolinska Institute in Sweden,
our research capabilities in positron emission
tomography, which provides early signalling
of potential efficacy for our Alzheimer’s
compounds, continue to progress. We now
have two C-11 diagnostic compounds and
one F-18 compound in development.
Compounds in clinical evaluation include
products deriving from our relationship with
Targacept (AZD3480, TC-5619 and AZD1446).
In the pipeline
PN400 is a fixed-dose combination tablet
of enteric-coated naproxen and immediate
release esomeprazole which uses proprietary
technology licensed from POZEN Inc. through
a collaboration established in August 2006.
It is being developed for the relief of signs and
symptoms of OA, rheumatoid arthritis and
ankylosing spondylitis in patients at risk for
developing non-steroidal anti-inflammatory
drug (NSAID)-associated gastric ulcers.
Approximately half of the 121 million chronic
arthritis patients in the US and the five largest
European countries are at risk of developing
NSAID-associated ulcers based on their age,
prior history of ulceration, or use of low dose
aspirin. The Phase III trial programme, which
was initiated in the third quarter of 2007, has
now completed enrolment. The two Phase III
ulcer risk reduction studies, comparing PN400
against enteric-coated naproxen 500mg in
subjects with chronic pain and who are at
risk for NSAID-associated ulcers, achieved
their primary endpoints. Subjects taking
PN400 experienced statistically significantly
fewer endoscopically confirmed gastric ulcers
than those taking naproxen. Two additional
Phase III studies are still ongoing. Upon
completion of the entire PN400 Phase III
clinical programme, AstraZeneca will make a
final determination regarding regulatory filing.
A regulatory submission for PN400 in the US
is currently planned for mid 2009.
We progressed three other early development
compounds during the year: AZD2516 into
Phase I clinical development and AZD1386 and
AZD1940 in Phase II clinical development for
the treatment of nociceptive (caused by
tissue damage) and/or neuropathic (caused
by nerve damage) pain.
ANALGESIA AND ANAESTHESIA
(PAIN CONTROL)
Significant unmet need remains for efficacy
and tolerability in the neuropathic pain
market. Several novel compounds are in
development but recent disappointments
highlight continuing uncertainty regarding
market approval.
The osteoarthritis (OA) market is steadily
growing, due to ageing populations and
novel agents entering the market. However,
the established use of generic treatment
makes market entry more difficult. Biologics
are an emerging treatment option for OA.
OUR FOCUS
Our key marketed products
Zomig Nasal Spray was approved for the
acute treatment of cluster headache in 14
member states in the EU in 2008.
Diprivan is the world’s best-selling intravenous
general anaesthetic. A complete change over
to Diprivan EDTA, a microbial-resistant
formulation, is expected in 2009, following
the approval of this formulation in the last
major territory (UK) in 2008.
Naropin approvals continue for extended use
in paediatric patients to include neonates and
infants aged below one year old.
EMLA submissions/approvals of patch
presentation have continued, particularly in
Eastern European countries. In Japan, EMLA
is out-licensed to SATO who expect to file
their Japanese NDA in July 2009.
OUR FINANCIAL PERFORMANCE
2008 2007 2006 2008 compared to 2007 2007 compared to 2006
Growth due Growth due
CER to exchange CER to exchange CER Reported CER Reported
Sales growth effect Sales growth effect Sales growth growth growth growth
$m $m $m $m $m $m $m % % % %
Seroquel 4,452 346 79 4,027 526 85 3,416 9 11 15 18
Diprivan 278 (3) 18 263 (53) 12 304 (1) 6 (17) (13)
Zomig 448 (3) 17 434 18 18 398 (1) 3 5 9
Local anaesthetics 605 13 35 557 (6) 34 529 2 9 (1) 5
Other 54 (7) 2 59 (1) 3 57 (12) (8) (2) 4
Total 5,837 346 151 5,340 484 152 4,704 6 9 10 14
DIRECtORs’ REPORt
63
ASTRAZENECA ANNUAL REPORT AND FORM 20-F INFORMATION 2008
FINANCIAL PERFORMANCE 2008/2007
PERFORMANCE 2008
Reported performance
Neuroscience sales grew by 9% to
$5,837 million in 2008 from $5,340 million
in 2007. All geographic areas experienced
growth and Seroquel grew strongly by 11%.
Performance – CER growth rates
Sales in the Neuroscience therapy area grew
by 6% to $5,837 million from $5,340 million
last year.
US sales for Seroquel for the full year were
$3,015 million, 5% ahead of last year.
Seroquel remains the market leader in the US
anti-psychotic market, with a total prescription
share of 31.6% in December 2008.
For the full year, Seroquel sales in the Rest
of World increased by 17% to $1,437 million,
with value and volume growth well ahead of
the market in all regions.
Sales of Zomig for the full year were up 6%
in the US to $187 million. Sales in the Rest of
World were down 5% to $261 million.
PERFORMANCE 2007
Reported performance
Sales in the Neuroscience therapy area rose
by 14% in 2007, up to $5,340 million from
$4,704 million in 2006. Seroquel was the
principal driver of performance, recording
an 18% increase in sales.
Performance – CER growth rates
Neuroscience sales grew by 10% at CER.
Annual Seroquel sales exceeded $4 billion
for the first time in 2007. Full year sales were
$4,027 million, up 15% over last year. In the
US, Seroquel sales increased by 15% to
$2,863 million. Seroquel sales in other markets
were up 16% for the full year, as a result of
market share gain in most markets.
Zomig sales for the full year increased 5%
in the US (to $177 million) and 4% in other
markets, totalling $434 million.
AZD3480, a neuronal nicotinic receptor
agent, is currently in Phase IIb clinical testing
in Alzheimer’s disease and TC-5619 is in
Phase II clinical testing for CDS. AZD3480
did not meet the Phase IIb trial primary
endpoint for CDS and is not expected to
progress to Phase III studies in this indication.
AstraZeneca and Targacept previously
announced top-line results from a Phase IIb
study of AZD3480 in mild to moderate
Alzheimer’s disease and are currently
evaluating AZD3480 in a Phase II exploratory
study in attention deficit/hyperactivity disorder
(ADHD) in adults. A decision by AstraZeneca
with respect to potential further development
of AZD3480 in Alzheimer’s disease or ADHD
is now expected in the first half of 2009,
pending completion of the adult ADHD study
and other ongoing evaluations.
FURTHER INFORMATION
AstraZeneca is defending approximately
9,210 served or answered lawsuits involving
approximately 15,461 plaintiff groups who
have filed Seroquel-related product liability
claims in the US and Canada. Although the
nature of the alleged injuries is not clear from
the face of most of the complaints and
discovery of the cases is continuing, plaintiffs
generally contend that they developed
diabetes and/or other related injuries as a
result of taking Seroquel and/or other atypical
anti-psychotic medications. Further information
can be found in Note 25 to the Financial
Statements on page 155. Trials of these
cases are expected to commence in 2009.
In July 2008 AstraZeneca was granted
a Summary Judgment Motion from the US
District Court for the District of New Jersey in
the ongoing patent infringement action against
Teva Pharmaceuticals USA Inc and Sandoz,
Inc. Teva and Sandoz have filed appeals.
Separate lawsuits have been filed in the US
against third party manufacturers relating to
infringement of the Seroquel XR patents.
We continue to have full confidence in our
intellectual property protecting Seroquel and
will vigorously defend and enforce it. Details of
the litigation against generic drug manufacturers
in respect of Seroquel are set out in Note 25
to the Financial Statements on page 155.
$ BILLION
17.7 CHEMOTHERAPY
13.2 MONOCLONAL ANTIBODIES
8.8 HORMONAL THERAPIES
6.4 SMALL MOLECULE TKIs
The world market value for cancer therapies is $46 billion
and is growing strongly.
An increasing number of large pharmaceutical companies as
well as biotechs have a stated ambition to build their business
in oncology. In the last several years there has been a substantial
increase of clinical trial activity across all the major tumours
and sub-types increasing pressure on innovator companies
to deliver best in class or first in class therapies. According to
IMS, value growth in oncology will continue at double digit
compound annual growth rates. This is well above growth
rates for other therapy areas which makes oncology, despite
market pressures, an attractive area for investment.
64
ASTRAZENECA ANNUAL REPORT AND FORM 20-F INFORMATION 2008
OUR STRATEGIC OBJECTIVE
We aim to build on our position as a world
leader in cancer treatment through continued
growth of Arimidex, further launches and
line extensions of newer products, such as
Faslodex, and the successful introduction
of novel therapeutic approaches currently in
development, including both small molecule
and biological drugs, targeted at high
unmet need.
CANCER
OUR FOCUS
Our key marketed products
During 2008, our breast cancer treatment,
Arimidex maintained its position as market
leader in sales of branded hormonal agents,
with approximately four million patient years
of clinical experience. This success is largely
based on the extensive long-term efficacy
and safety results of the ATAC study, which
showed Arimidex to be significantly superior
to tamoxifen at preventing breast cancer
recurrence during and beyond the five-year
treatment course. (Breast cancer recurrence
is defined as loco-regional recurrence, distant
recurrence or contra-lateral breast cancer).
Arimidex continues to be the leading branded
hormonal therapy for new patients in the US,
Japan and France, and is also approved in
a number of markets in Europe for a switch
indication for patients who have already
received two to three years of tamoxifen.
Faslodex, now approved in more than 60
markets, offers an additional hormonal therapy
for patients with hormone-sensitive, advanced
breast cancer, delaying the need for cytotoxic
chemotherapy. It is a once-monthly injection
approved for the second-line treatment of
hormone-receptor positive, advanced breast
cancer in post-menopausal women.
Casodex is used as a 50mg tablet for the
treatment of advanced prostate cancer, and
as a 150mg tablet for the treatment of locally
advanced prostate cancer. European sales
declined due to generic erosion following
patent and/or marketing exclusivity expiries in
July 2008. Sales growth continued in Japan,
where Casodex is available as an 80mg tablet
and is approved for all stages of prostate
cancer. In the US, the FDA granted an
additional six months’ paediatric extension
providing marketing exclusivity in the US to
April 2009.
Zoladex is approved in 120 countries. It is
approved for the treatment of prostate cancer,
breast cancer and gynaecological disorders.
In non-metastatic prostate cancer, Zoladex
is the only luteinising hormone-releasing
hormone (LHRH) agonist shown to improve
overall survival both when used in addition
to radical prostatectomy and when used
in addition to radiotherapy. The 10-year
follow-up results of a study for the European
Organisation for Research and Treatment
of Cancer confirmed the long-term survival
benefits of Zoladex when used as adjuvant to
radiotherapy in patients with locally advanced
prostate cancer.
In breast cancer, Zoladex is widely approved
for use in advanced breast cancer in
pre-menopausal women. In a number of
countries, Zoladex is also approved for
the adjuvant treatment of early stage pre-
menopausal breast cancer as an alternative
to and/or in addition to chemotherapy.
Zoladex offers proven survival benefits for
breast cancer patients with a favourable
tolerability profile.
Competition in the LHRH agonist market is
expected to increase in Europe during 2009,
with the anticipated launches of generic
goserelin. This follows the announcement of
the approval of generic goserelin (one-month
depot) in Germany in December.
Iressa is approved in 36 countries and is
the leading epidermal growth factor receptor-
tyrosine kinase inhibitor (EGFR-TKI) in the
Asia Pacific region where it continues to be
marketed for pre-treated advanced NSCLC.
Based on data from the Phase III INTEREST
study comparing Iressa with docetaxel, a
marketing authorisation application for Iressa
has been submitted to the European
Medicines Agency.
Outside the US, we have various distribution
and marketing arrangements for branded
Ethyol. As of June 2008, our two main
distribution partners are Pinnacle Biologics
for Western Europe, Turkey and Israel,
and Schering-Plough International for Rest
of World.
Clinical trial developments
Results from the Phase III pan-Asian IPASS
study evaluating the efficacy of Iressa as
first-line treatment of NSCLC, were also
announced. The IPASS study exceeded its
primary objective, demonstrating superior
ONCOLOGY
2008 IN BRIEF
Arimidex > sales up 4% to $1.86 billion and is the
leading branded hormonal breast cancer therapy
in the US, Japan and France.
Casodex > sales $1.26 billion, down 12%. Expiry of
EU marketing exclusivity in 2008.
Zoladex > sales $1.14 billion, down 3%.
Results from three Phase III > Zactima trials in
non-small cell lung cancer (NSCLC) showed
that Zactima, in combination with standard
chemotherapy, brings clinical benefits to
patients with previously treated NSCLC.
Results from the > Iressa Phase III INTEREST study
underpin a marketing authorisation application in
the EU and the pan-Asian IPASS study met its
primary objective showing superior progression-
free survival for Iressa compared with two
chemotherapies in clinically selected patients.
ZD4054 progressed into Phase III development >
for hormone-resistant prostate cancer.
Registration trials ongoing of > Recentin in first
line colorectal cancer and recurrent
glioblastoma multiforme.
OUR MARKETED PRODUCTS
Arimidex (anastrozole) is an aromatase inhibitor
for the treatment of breast cancer.
Casodex (bicalutamide) is an anti-androgen
therapy for the treatment of prostate cancer.
Zoladex (goserelin acetate implant), in one- and
three-month depots, is an LHRH agonist for the
treatment of prostate cancer, breast cancer and
certain benign gynaecological disorders.
Iressa (gefitinib) is an EGFR-TKI that acts to
block signals for cancer cell growth and survival
in non-small cell lung cancer.
Faslodex (fulvestrant) is an injectable oestrogen
receptor antagonist for the treatment of breast
cancer, with no known agonist effects, that
down-regulates the oestrogen receptor.
Nolvadex (tamoxifen citrate) remains a widely
prescribed breast cancer treatment outside the US.
Ethyol (amifostine) is used to help prevent certain
side effects of specific types of chemotherapy and
radiotherapy that are used to treat head and neck
and ovarian cancer.
Abraxane
®
(paclitaxel protein-bound particles for
injectable suspension) (albumin-bound) for the
treatment of breast cancer
1
.
THERAPY AREA WORLD MARKET (MAT/Q3/08)
1
In November 2008, we entered into an agreement with
Abraxis under which Abraxis re-acquired exclusive
rights to market Abraxane
®
in the US.
DIRECtORs’ REPORt
65
ASTRAZENECA ANNUAL REPORT AND FORM 20-F INFORMATION 2008
progression-free survival (PFS) for Iressa
compared with two chemotherapies
(carboplatin/paclitaxel) in clinically selected
patients. AstraZeneca is consulting with
relevant health authorities regarding the
IPASS data. Further Phase II trials are
continuing to evaluate the potential benefits
of Iressa in NSCLC and other EGF receptor-
driven tumours.
In the pipeline
Zactima (vandetanib) is a potential new oral
anti-cancer therapy, which has a unique
anti-cancer profile through two clinically
proven mechanisms. It blocks the development
of a tumour’s blood supply (anti-angiogenesis)
and blocks the growth and survival of the
tumour itself (anti-EGFR). Zactima also inhibits
RET-kinase activity, an important growth
driver in certain types of thyroid cancer.
During 2008, we announced results from
two Phase III clinical studies of Zactima in
combination with chemotherapy agents,
docetaxel (ZODIAC) and pemetrexed (ZEAL),
and one monotherapy clinical study (ZEST) in
pre-treated advanced NSCLC. The observed
safety profile in these three Phase III studies
was consistent with previous studies with
Zactima in NSCLC.
Results from the ZODIAC and ZEAL studies
showed advantages for Zactima in combination
with standard chemotherapy, compared to
chemotherapy alone. The addition of Zactima
to chemotherapy prolonged PFS, the primary
endpoint, which achieved statistical
significance in the ZODIAC study, but not in
the smaller ZEAL study. Clinical benefits were
seen in secondary endpoints. Both studies
showed that adding Zactima to chemotherapy
significantly improved objective response rate,
which is a measurement of tumour shrinkage.
Additionally, positive trends in prolonging
overall survival (OS) were seen, although
these did not reach statistical significance
and the data are still immature. Importantly,
the studies also showed that adding Zactima
to chemotherapy controlled the symptoms of
lung cancer better than chemotherapy alone,
allowing patients to maintain their quality of
life for significantly longer.
ZEST, which evaluated the efficacy of Zactima
monotherapy versus erlotinib, did not meet
the primary objective of demonstrating
a statistically significant prolongation of PFS
for Zactima. However, Zactima and erlotinib
showed equivalent efficacy for PFS and OS
in a pre-planned non-inferiority analysis.
We plan to file a regulatory submission in the
second quarter of 2009 following discussion
with regulatory agencies for combination
therapy. Full results from studies ZODIAC,
ZEAL and ZEST will be presented at an
international medical congress in 2009.
Results from the Phase III ZETA study in
hereditary and sporadic medullary thyroid
cancer are expected in the second quarter
of 2009.
The anti-cancer activity of Zactima continues
to be evaluated in NSCLC and other tumour
types, including colorectal, glioma, head and
neck, breast and prostate cancers.
Recentin (cediranib) is a highly potent and
selective-inhibitor of vascular endothelial cell
growth factor (VEGF) receptor signalling in
solid tumours, which inhibits all three VEGF
receptors irrespective of activating ligand,
and is suitable for once-daily oral dosing. It is
currently in Phase III development in first-line
colorectal cancer (CRC) and recurrent
glioblastoma (rGBM).
In early 2008, our HORIZON III Phase II/III
head-to-head study of Recentin with
chemotherapy versus Avastin
with
chemotherapy in patients with first-line
metastatic CRC progressed directly into
Phase III. Patient recruitment was subsequently
completed for both HORIZON III and
HORIZON II, our Phase III study of Recentin
with chemotherapy versus chemotherapy
alone. The Phase III REGAL trial in rGBM
comparing Recentin monotherapy versus
lomustine +/- Recentin began enrolling
patients in the fourth quarter of 2008.
Following the announcement that the National
Cancer Institute of Canada Clinical Trial
Group’s (NCIC CTG) Recentin BR24 NSCLC
trial would not be progressing straight into
Phase III, we worked in close collaboration
with the NCIC CTG to understand the BR24
data further and to assess the potential of
Recentin in this disease area. Subsequently
the NCIC CTG announced it would now
investigate Recentin at 20mg plus
carboplatin/paclitaxel versus carboplatin/
paclitaxel alone in the BR29 study, which is
expected to start recruitment in early 2009.
Encouraging Phase II data for Recentin
from completed and continuing studies to
investigate renal, rGBM, ovarian and prostate
cancers were also presented in 2008.
ZD4054 is an oral once-daily potent and
specific endothelin A-receptor antagonist in
Phase III development. Data from Phase II
studies suggested that ZD4054 10mg has
the potential to increase median overall
survival time by approximately seven months
in men with metastatic hormone-resistant
prostate cancer (HRPC), with the benefit of
a generally well-tolerated side effect profile
and a convenient once-daily tablet. The
Phase III ENTHUSE studies are investigating
OUR FINANCIAL PERFORMANCE
2008 2007 2006 2008 compared to 2007 2007 compared to 2006
Growth due Growth due
CER to exchange CER to exchange CER Reported CER Reported
Sales growth effect Sales growth effect Sales growth growth growth growth
$m $m $m $m $m $m $m % % % %
Casodex 1,258 (161) 84 1,335 74 55 1,206 (12) (6) 6 11
Arimidex 1,857 69 58 1,730 151 71 1,508 4 7 10 15
Zoladex 1,138 (31) 65 1,104 39 57 1,008 (3) 3 4 10
Iressa 265 8 19 238 (1) 2 237 3 11
Faslodex 249 25 10 214 18 10 186 12 16 10 15
Nolvadex 85 (5) 7 83 (8) 2 89 (6) 2 (9) (7)
Abraxane
®
64 2 62 44 18 3 3 244 244
Ethyol 28 (15) 43 43 n/m n/m n/m n/m
Other 10 (1) 1 10 (1) 1 10 (10) (10)
Total 4,954 (109) 244 4,819 359 198 4,262 (2) 3 8 13
66
ASTRAZENECA ANNUAL REPORT AND FORM 20-F INFORMATION 2008
Faslodex sales were up 12% with a 5%
increase in the US and 18% in other markets.
PERFORMANCE 2007
Reported performance
Oncology sales increased by 13% to reach
$4,819 million in 2007, compared with
$4,262 million in 2006.
Performance – CER growth rates
Oncology sales grew by 8% at CER. Arimidex
sales reached $1,730 million, up 10%. In the
US, sales of Arimidex rose by 13% to
$694 million. Total prescriptions for Arimidex
increased nearly 5.3% compared with 1.3%
growth in the market for hormonal treatments
for breast cancer. Arimidex sales in other
markets increased by 8% to $1,036 million.
Sales for the full year were up 6% in Western
Europe and increased 9% in Japan.
Casodex sales increased by 6% to
$1,335 million. Sales in the US for the full
year were up 1% to $298 million. Sales in
other markets, which accounted for more
than 75% of product sales, were up 8%,
on 6% growth in Western Europe and 13%
sales growth in Japan.
Iressa sales were unchanged for the full year.
Sales in Japan increased 4% for the year;
sales in China were up 24%.
Faslodex sales increased 10% to $214 million
for the full year, on growth of 3% in the US
and 18% sales growth in other markets.
patients suffering from certain lymphomas
and leukaemias. Exclusive rights to develop
and commercialise blinatumomab in North
America have been granted from Micromet.
The US Phase I programme with
blinatumomab was suspended during 2008
in order to make appropriate modifications
to the dosing regimen based on preliminary
results from the EU studies.
FURTHER INFORMATION
In April 2008, Sun Pharmaceuticals launched
generic amifostine in the US. In response,
we extended an agreement with Bedford
Laboratories to launch an authorised generic
amifostine for oncology in the US. We have
ceased all active promotion of branded Ethyol
in the US. We have an active infringement
action against Sun Pharmaceuticals regarding
certain Ethyol patents.
Abraxane
®
, discovered, developed and
owned by Abraxis, uses a novel technology
to deliver paclitaxel for the treatment of
breast cancer. During 2008, we co-promoted
Abraxane
®
in the US under an agreement
with Abraxis. In November 2008, we entered
into an agreement with Abraxis under which
Abraxis re-acquired exclusive rights to market
Abraxane
®
in the US. Under the agreement,
the board of Abraxis’ parent ended the
Co-Promotion Agreement. Upon termination,
Abraxis will pay AstraZeneca a $268 million
fee on 31 March 2009.
FINANCIAL PERFORMANCE 2008/2007
PERFORMANCE 2008
Reported performance
Sales in Oncology increased by 3% on a
reported basis to $4,954 million up from
$4,819 million in 2007.
Performance – CER growth rates
Sales in the Oncology therapy area were
down 2% at CER. Arimidex sales were up 4%
to $1,857 million. In the US, Arimidex sales
were up 9% to $754 million. In other markets,
sales increased by 1% to $1,103 million.
Casodex sales decreased by 12% to $1,258
million, with sales in the US down by 2% and
sales in other markets down by 15%.
Iressa sales for the year were up 3% as growth
in China and other Emerging Markets more
than offset the 3% decline in sales in Japan.
efficacy in metastatic HRPC, both as
monotherapy and in combination with
docetaxel, and in non-metastatic HRPC.
In December 2008, we ceased our
collaboration with Infinity Pharmaceuticals for
the development and commercialisation of
Infinitys drug candidates IPI-504 (MEDI-561)
and IPI-493 for the treatment of cancer and
related conditions. This decision was taken
after reviewing the potential opportunity for
these projects and to take account of
competing R&D investment priorities.
Our early oncology pipeline includes a range
of novel compounds that target signalling
pathways believed to be pivotal in cancer cell
growth, invasion DNA repair and survival,
with nine products in Phase II and 15 others
in Phase I development. Phase II data from
AZD6244, a potent MEK inhibitor licensed
from Array BioPharma, showed biological
activity in lung cancer and melanoma and
studies will now focus on its use in combination
with standard and other novel therapies,
rather than its development as monotherapy.
Phase II studies with the poly-ADP-ribose-
polymerase (PARP) inhibitor AZD2281 have
started and will initially focus on BRCA-mutated
breast and ovarian cancer as well as other
cancers where DNA repair could be defective.
The dual-specific Src/Abl kinase inhibitor,
AZD0530, has shown a dramatic effect on
biomarkers of cell motility and bone resorption
and has started Phase II studies in ovarian
cancer with others to follow. Among the
compounds from the early portfolio continuing
in development are AZD4877, a novel inhibitor
of cell cycle; AZD7762, a tumour-selective
chemosensitiser; and AZD8931. AZD1152,
an aurora kinase inhibitor, has shown activity
in acute myelogenous leukaemia and will
commence Phase II/III studies in 2009.
We are also developing potential new cancer
treatments using biological approaches with
highly defined molecular targets for patient
populations with unmet medical needs.
CAT-8015 is an immunotoxin fusion protein
that targets CD22, which is a receptor
expressed on the surface of a wide variety
of B-cell malignancies. CAT-8015 has orphan
drug designation for hairy cell leukaemia in
the US and EU. In 2008, the enrolment for
studies continued in the CAT-8015 Phase I
development programme.
Blinatumomab (MEDI-538) is a recombinant
single-chain bi-specific T-cell engager (BiTE
)
molecule that is being studied for use in certain
$ BILLION
16.1 ASTHMA
9.4 COPD
7.4 RHINITIS
19.9 OTHER
The prescription Respiratory world market value
is $53 billion.
The World Health Organization estimates that 100 million
people worldwide suffer from asthma and more than twice
that from chronic obstructive pulmonary disease (COPD),
which is currently the fourth leading cause of death in the
world with further increases in the prevalence and mortality
of the disease predicted for the coming decades.
DIRECtORs’ REPORt
67
ASTRAZENECA ANNUAL REPORT AND FORM 20-F INFORMATION 2008
OUR STRATEGIC OBJECTIVE
We aim to build on our strong position in
asthma treatment through the growth of key
products, particularly Symbicort, with new
indications and market launches as well as
developing novel approaches to other areas
of inflammatory disease such as chronic
obstructive pulmonary disease (COPD)
and rheumatology.
COPD AND ASTHMA
COPD is expected to become the world’s
third biggest health threat by 2020. Current
treatment has recently demonstrated some
survival benefit but the prognosis of the COPD
patient remains poor. In asthma, morbidity
and mortality remain important issues and
disease normalisation is not achieved by
any treatment.
The typical treatment across COPD and
asthma is a fixed-dose combination of an
inhaled corticosteroid (ICS) with a long-acting
beta-agonist (LABA) or for COPD specifically,
inhaled long-acting muscarinic agonist (LAMA).
Other major asthma treatments include oral
leukotriene receptor antagonists and oral
steroids for severe disease and (in combination
with antibiotics) for exacerbations. Significant
new product classes impacting the asthma
market up to 2015 are unlikely. First novel
anti-inflammatory compounds aimed mainly
at prevention and/or treatment of COPD
exacerbations, such as oral phosphodiesterase
4 inhibitors, may appear on the market
before 2015.
Symbicort SMART flexible dosing introduced
a step change to asthma care in Europe
resulting in lower ICS and oral steroid use.
Novel ICS/LABA combination products for
this area are expected from 2009 and generic
ICS/LABA combinations may be available
from the early part of the next decade. Several
companies are developing new biologics for
severe asthma, including improved versions
of anti-IgE and differentiated anti-cytokine
antibodies. Post-2015, immune response
modifiers could deliver intermittent therapy
for moderate to severe asthma.
A number of novel COPD combinations in
industry pipelines may change the way in
which COPD is managed. Combinations of
LABAs, LAMAs and triple-combinations with
existing and new anti-inflammatories, may
become future treatments of choice. There
are also agents in early development with the
potential to change the course of the disease
by targeting the immune and inflammatory
response that results in lung damage.
OUR FOCUS
Our key marketed products
Symbicort Turbuhaler provides rapid, effective
control of asthma and effective reduction of
exacerbations, improving symptoms and
providing a clinically important improvement
in the health of patients with severe COPD.
Symbicort Rapihaler (pMDI) approved for the
long-term maintenance treatment of asthma
in patients 12 years of age and older, was
launched in the US in 2007. Further information
about the progress of Symbicort since its
launch in the US is set out in the Geographical
Review on page 49. In December 2008, the
Joint Advisory Committees of the FDA
completed a review of the benefits and risks
of asthma medications containing LABAs.
This concluded that the benefits of Symbicort
outweigh the risks in adult and adolescent
asthma patients.
Symbicort SMART provides increased asthma
control and simplifies asthma management
through use of only one inhaler for both
maintenance and relief of asthma symptoms.
It is also a cost-effective treatment option for
many healthcare payers. Symbicort SMART
is included in the Global Initiative for Asthma,
the international treatment guidelines.
The US sNDAs for Symbicort Rapihaler (pMDI)
in COPD and paediatric asthma in the US
were submitted as planned during the second
quarter of 2008. Our existing regulatory filings
for Symbicort Rapihaler (pMDI) in the EU for
asthma and COPD were supplemented with
data supporting two additional strengths in
the second half of 2008.
Pulmicort remains one of the world’s leading
asthma medicines and is available in several
forms. Pulmicort pMDI is now approved in
98 countries.
Information about our settlement of the patent
infringement action against IVAX in the US,
which began in October 2005, in relation to
IVAX’s ANDA for a budesonide inhalation
suspension is set out in Note 25 to the
Financial Statements from page 154.
Oxis is added to the treatment regime when
corticosteroid treatment alone is not adequate.
Oxis is also indicated for symptom relief
in COPD.
Rhinocort combines powerful efficacy with
rapid onset of action and minimal side effects
and is available as a once-daily treatment in
the Rhinocort Aqua (nasal spray) and the
Turbuhaler dry powder inhaler forms.
REsPIRAtORY AND INFLAMMAtION
2008 IN BRIEF
Symbicort > sales over $2 billion, up 22%.
Symbicort Rapihaler > (pMDI) licensed for
long-term maintenance treatment of asthma
in the US. Submissions made for use in COPD
and paediatric asthma.
Outside the US, > Symbicort Turbuhaler SMART
now approved for use in managing asthma in
over 90 countries.
Symbicort Turbuhaler > now approved in COPD in
over 80 countries.
The Joint Advisory Committee of the FDA >
concluded that the benefits of Symbicort
outweigh the risks in adult and adolescent
asthma patients.
Continued growth for > Pulmicort with sales of
$1.49 billion.
Settlement of AstraZeneca’s > Pulmicort Respules
patent infringement litigation against Teva
including an exclusive licence to Teva to sell
generic Pulmicort Respules from 15 December
2009 with significant royalties for AstraZeneca.
OUR MARKETED PRODUCTS
Symbicort Turbuhaler (budesonide/formoterol
in a dry powder inhaler) is a combination of an
inhaled corticosteroid and a fast onset, long-acting
bronchodilator for the treatment of asthma
and COPD.
Symbicort SMART is licensed for maintenance
therapy as well as for maintenance and reliever
therapy in persistent asthma.
Symbicort Rapihaler (pMDI) (budesonide/
formoterol in a pressurised metered-dose inhaler)
for the maintenance treatment of asthma.
Pulmicort (budesonide) is a corticosteroid
anti-inflammatory inhalation drug that helps prevent
symptoms and improves the control of asthma.
Pulmicort Respules (budesonide inhalation
suspension) is the first and only nebulised
corticosteroid in the US for the treatment of asthma
in children as young as 12 months.
Rhinocort (budesonide) is a nasal steroid
treatment for allergic rhinitis (hay fever), perennial
rhinitis and nasal polyps.
Oxis (formoterol) is a fast onset, long-acting
beta-agonist for treating asthma and COPD.
Accolate (zafirlukast) is an oral leukotriene receptor
antagonist for the treatment of asthma.
THERAPY AREA WORLD MARKET (MAT/Q3/08)
68
ASTRAZENECA ANNUAL REPORT AND FORM 20-F INFORMATION 2008
is subject to review in the US under the
Hart-Scott-Rodino Act and becomes effective
after the waiting period has ended. UDB is
being developed by MAP Pharmaceuticals
as a potential treatment for paediatric asthma
and is currently in Phase III clinical development.
UDB has the potential to be nebulised more
quickly and at a lower nominal dose than the
commercially available product. AstraZeneca
and Dainippon Sumitomo have a well-
established alliance to discover and develop
small molecules directed towards toll-like
receptor 7 and the first compound from this
alliance has entered early stage development.
The partnership with Dynavax Technologies
Corporation, which began in 2006, continues
to pursue opportunities in the field of toll-like
receptors. Dynavax has unique competence
in generating immunostimulatory DNA
sequences that activate toll-like receptors.
The alliance should enable us to expand our
portfolio of small molecule and biological
drugs to treat asthma and COPD.
Our 2007 discovery alliance with Argenta
Discovery Limited aimed at identifying improved
bronchodilators to treat COPD continues.
Our three-year research collaboration with
Silence Therapeutics, established in 2007,
is continuing. In 2008 we entered into a new
collaboration with this company focused on the
development of a range of novel approaches
for the delivery of siRNA molecules, which
allows both Silence Therapeutics and
AstraZeneca to commercialise the novel
delivery systems we develop together.
RHEUMATOLOGY
Rheumatoid arthritis (RA) is currently treated
with generic disease-modifying anti-rheumatic
agents and, where the relevant criteria are
met, biologic disease-modifiers. There remains
a need for novel effective treatments since
only about a third of patients treated with
biologics achieve their treatment goals.
CAT-354 targets interleukin-13 (IL-13). In 2008,
we initiated two new studies with CAT-354:
a Phase II trial in Europe and Australia designed
to assess the potential of this MAb in patients
with uncontrolled asthma despite optimal
treatment, and a US Phase I study to assess
pharmacokinetics in healthy adult patients.
The early pipeline has been reshaped to focus
more on COPD, looking for novel strategies
to inhibit exacerbations in COPD which include
regulation of inflammatory cell migration and
activation with MAbs directed to antigen.
These include CXCR3, as well as inhibition of
molecules involved in both viral and bacterial
mediated exacerbations. A number of small
molecule approaches for the treatment of
COPD are in development. AZD1236 is a
potent MMP inhibitor currently in Phase II,
the expression of these proteins are
associated with key pathological features of
the disease including bronchiolitis, vasculitis
and emphysema. Human Neutrophil Elastase
(HNE) is a key factor in cigarette smoke
induced inflammation, lung injury and
emphysema and AZD9668, a potent and
selective oral, reversible inhibitor of HNE,
also in Phase II, is expected to reduce the
progression and severity of COPD.
Alongside these novel approaches and building
on our capabilities in combinations and device
development demonstrated through our
experience with Symbicort, we are aiming to
improve further the symptom relief delivered by
on-market bronchodilators, the mainstay of
treatment for all COPD patients. By combining
two enhanced bronchodilators in one inhaler,
patients should benefit from improved symptom
control, as well as reducing the complications
of multiple dosing or inhaler devices.
Strategic collaboration activity makes a key
contribution to our respiratory pipeline.
AstraZeneca and MAP Pharmaceuticals
announced in December 2008 an exclusive
worldwide agreement to develop and
commercialise Unit Dose Budesonide (UDB),
MAP Pharmaceuticals’ proprietary nebulised
formulation of budesonide. This agreement
Clinical trial developments
In the latter part of 2008, data from one of
the pivotal US COPD studies were published
(SHINE), confirming the efficacy and tolerability
of Symbicort Rapihaler (pMDI) in COPD.
In the pipeline
Our monoclonal antibody (MAb) programmes
for asthma treatments focus on targeting
interleukins which appear to play a role in
the regulation of inflammatory and immune
responses and, therefore, may improve the
treatment and/or prevention of asthma. Most
of these MAbs are in Phase II to assess their
potential to affect the significant remaining
unmet medical need in the disease including
uncontrolled asthma and moderate to severe
persistent asthma. Concurrent Phase I activity
is supporting our understanding of the impact
of these large molecules on asthma biology.
MEDI-563 is an investigational approach that
may treat or help prevent asthma by targeting
the interleukin-5 (IL-5) receptor to neutralise
the binding of IL-5 and deplete the cells
expressing the IL-5 receptor, typically
eosinophils, as both IL-5 and eosinophils are
thought to play key roles in the pathology of
asthma. In 2008, the results of a Phase I
study presented at the European Respiratory
Society meeting showed that MEDI-563
exhibited an acceptable safety profile and
showed pharmacological activity in mild
asthmatics. In addition, a Phase I study to
measure the depletion of eosinophils in the
airways of asthmatics and a Phase II study
with this anti-IL-5 receptor MAb to assess
whether it can reduce the incidence of
asthmatic relapse in subjects following an
asthmatic episode that required hospitalisation
have been initiated.
Also in 2008, we completed two out of three
ongoing Phase IIa studies evaluating the
potential for MEDI-528 (anti-IL-9 MAb) to treat
or prevent symptomatic, moderate to severe
persistent asthma, and a fourth Phase IIa
clinical trial, designed to assess its effectiveness
in patients with stable asthma and exercise-
induced bronchoconstriction, was initiated.
OUR FINANCIAL PERFORMANCE
2008 2007 2006 2008 compared to 2007 2007 compared to 2006
Growth due Growth due
CER to exchange CER to exchange CER Reported CER Reported
Sales growth effect Sales growth effect Sales growth growth growth growth
$m $m $m $m $m $m $m % % % %
Pulmicort 1,495 7 34 1,454 128 34 1,292 3 10 13
Symbicort 2,004 346 83 1,575 265 126 1,184 22 27 22 33
Rhinocort 322 (41) 9 354 (16) 10 360 (12) (9) (4) (2)
Oxis 71 (21) 6 86 (9) 7 88 (24) (17) (10) (2)
Accolate 73 (4) 1 76 (6) 1 81 (5) (4) (7) (6)
Other 163 (9) 6 166 7 13 146 (5) (2) 5 14
Total 4,128 278 139 3,711 369 191 3,151 7 11 12 18
DIRECtORs’ REPORt
69
ASTRAZENECA ANNUAL REPORT AND FORM 20-F INFORMATION 2008
Pulmicort sales were flat at $1,495 million, with
US sales up 2% as the generic competition
from the Teva product affected quarter four
sales. US sales for Pulmicort were down
15% to $260 million in the fourth quarter and
Pulmicort Respules sales were down 18%
as a result of the “at risk” launch of generic
budesonide inhalation suspension (BIS) on
18 November. The patent litigation between
Teva and AstraZeneca was subsequently
settled on 26 November. The agreement allows
Teva to commence sales of BIS under an
exclusive licence from AstraZeneca beginning
15 December 2009. The agreement also
provided that any product already shipped by
Teva would remain in the market to be further
distributed and dispensed. As a result, Teva
products accounted for nearly 15% of total
prescriptions for BIS products dispensed
during the fourth quarter, including a 40%
share in December 2008. US sales for
Pulmicort for the full year were $982 million.
Pulmicort Respules accounted for around
90% of total Pulmicort sales in the US. Sales
of Pulmicort in Rest of World were down
2% for the full year to $513 million.
PERFORMANCE 2007
Reported performance
Continued growth from Symbicort drove
the increase in reported sales for R&I, which
grew by 18% from $3,151 million in 2006 to
$3,711 million in 2007.
Performance – CER growth rates
Sales in R&I increased by 12% at CER.
Symbicort sales for the full year were up 22%
to $1,575 million. Sales in Western Europe
were up 16%, with market share up another
point in the last 12 months, aided by the
roll-out of the Symbicort SMART regime.
Good growth for the year was achieved in
Canada (up 25%) and in Emerging Markets
(up 26%). Sales in the US were $50 million
since launch at the end of June 2007.
Specialist physicians rapidly adopted the
product; nearly 75% of allergists and more
than 60% of pulmonary specialists in our
target audience have prescribed Symbicort.
Pulmicort sales increased by 10% to $1,454
million. US sales increased 15% for the full
year to $964 million. Pulmicort Respules
sales in the US were up more than 20% for
the full year, on estimated volume growth of
15%. Of the approximately six million children
under the age of eight who are treated for
asthma, more than one million benefit from
treatment with Pulmicort Respules. Sales in
other markets were unchanged for the year.
Rhinocort sales fell by 4% to $354 million,
with a 9% decline in the US being
compensated by small gains elsewhere.
AZD9056 and AZD5672 are novel oral
compounds being primarily developed as a
new generation of disease modifying
anti-rheumatoid arthritis drugs. Currently in
Phase IIb, their different mechanisms of
action (a P2X7 antagonist and a CCR5
antagonist) provide multiple chances of
success to provide significant new choice in
the management of RA.
We also have an ongoing alliance with Bayer
Schering in respiratory and rheumatology
indications with the objective of identifying
novel compounds without steroid side effects.
FURTHER INFORMATION
Patent infringement litigation filed by
AstraZeneca against IVAX Pharmaceuticals
(a wholly owned subsidiary of Teva
Pharmaceuticals USA (Teva)) following the
submission of an ANDA with the FDA for
generic Pulmicort Respules was settled in
November 2008. Under the terms of the
settlement, Teva concedes that the patents
asserted by AstraZeneca in the litigation are
valid and enforceable and that its generic
version of Pulmicort Respules infringes
AstraZeneca’s patents. See Note 25 for
further details.
FINANCIAL PERFORMANCE 2008/2007
PERFORMANCE 2008
Reported performance
Sales in Respiratory and Inflammation
therapy area (R&I) increased by 11% to
$4,128 million from $3,711 million in 2007.
Performance – CER growth rates
R&I sales grew by 7% at CER.
Sales of Symbicort grew by 22% to
$2,004 million. In the US, sales of the
product were $255 million, up 410%.
Product trial rate among target specialist
physicians is now approaching 90%; these
specialists are now starting more than 30%
of patients new to combination therapy on
Symbicort. More than half of target primary
care physicians have prescribed Symbicort,
and share of new patient starts is just under
18%. Overall, Symbicort share of new
prescriptions for fixed combinations reached
11.7% in the week ending 16 January, with
market share among patients newly starting
combination treatment at 18.3%. Symbicort
sales in other markets in the year were
$1,749 million, up 9%. Symbicort SMART
has now been approved in 91 markets.
The RA market has grown from $1.3 billion in
1998 to over $10 billion in 2008, driven largely
by the introduction of biologic tumour necrosis
factor alpha (TNFa) blockers (first Amgen/
Wyeth’s Enbrel
, followed by Centocor/
Schering-Plough’s Remicade
and Abbott’s
Humira
), which together account for over
$8 billion in this disease alone. Launches of
additional TNF blockers are imminent, and
use of other biologic approaches, currently
reserved for TNF failures, is expected to
increase. Targeted novel oral drugs aimed
at patients that currently choose not to take,
are ineligible for or don’t respond to biologics,
are in development to provide anti-TNF-like
efficacy with safety benefits and more
convenient dosing.
Current treatment of systemic lupus
erythematosus (SLE) focuses on controlling
disease flares, preventing renal failure and
suppressing symptoms to an acceptable level
while minimising toxicity. Despite considerable
recent development activity, no targeted
disease-modifying agents have yet been
successfully launched for SLE. Most emerging
biologic agents will likely be used initially
in combination with corticosteroids or
immunosuppressants to provide incremental
benefit and/or allow reduced doses or
numbers of these agents.
OUR FOCUS
In the pipeline
In 2008, we invested in several novel multi-
functional MAbs that allow simultaneous
inhibition of either two secreted proteins or
surface receptors. Our first disease being
studied is RA, where TNF inhibitors with
other molecules may improve both the
efficacy and prevent the establishment of
TNF refractory disease while maintaining an
acceptable safety profile.
MEDI-545 is a MAb targeting interferon-
alpha, which regulates processes involved
in autoimmune diseases. In 2008, we
initiated a Phase IIa trial in patients with
SLE and a Phase I study in patients with
active dermatomyositis.
CAM-3001 is a MAb with potential to help
patients with RA. The antibody targets the
alpha sub-unit of the granulocyte-
macrophage colony stimulating factor
receptor. In September 2008, preliminary
results were reviewed from the first Phase I
study of CAM-3001, which had been initiated
to evaluate the safety profile and tolerability
of single doses in patients with RA.
AstraZeneca, through its acquisition of
MedImmune, acquired exclusive
development rights to the CAM-3001
programme from CSL Limited in 2007.
70
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
ASTRA TECH
Astra Tech is engaged in the research,
development, manufacture and marketing
of medical devices and implants for use
in healthcare, primarily in urology, surgery
and odontology. It has a leading position in
several countries in Europe and is expanding
its operations in key markets, particularly in
the US, Japan and South East Asia.
All product lines showed continued good
sales growth in 2008. In pursuit of its growth
strategy for Astra Tech Dental, the sales and
marketing organisation for dental implants
was further expanded during the year. Despite
the downturn in the world economy, which
negatively impacted business in the US,
strong sales growth was achieved in major
European countries as well as North America
and Astra Tech increased its market share in
the major markets. The economic slowdown
is expected to continue to adversely impact
demand in 2009.
In March 2008 a Regional Office for South
East Asia was established in Malaysia, in
order to provide an improved support and
service to our customers in the region.
Atlantis, which was acquired in 2007 and has
provided Astra Tech with a new platform for
development within digital dentistry is offering
an important opportunity for continued
growth for the dental implants product line.
During the year a European manufacturing
facility for Atlantis products was built at the
company’s headquarters site in Mölndal.
Production started in October to supply
all European markets.
The Astra Tech Training and Education
Program has been further developed and in
combination with its state-of-the-art Centre
for Training and Education at its headquarters,
advanced international education programmes
and seminars are now being offered to
existing and potential customers. Further
investments have been made in R&D, clinical
research and new production facilities to
strengthen the product portfolio.
ApTIum oNColoGY
For more than 25 years, Aptium Oncology
has been developing and managing
hospital-based outpatient cancer centres
in the US. Its distinctive and comprehensive
approach to cancer care incorporates all
outpatient oncology and ancillary services in
a single facility for maximum patient comfort
and convenience.
Ownership of Aptium Oncology gives us a
unique window to the provider sector of the
US oncology market and, through Aptium
Oncology’s network of over 160 physicians,
access to many opinion leaders in the field of
oncology who can help shape early phase
drug development decisions. It is also involved
in clinical trial delivery for a number of our
pipeline products and provides scientific
advice and staff training for oncology teams.
In 2008, Aptium Oncology continued to
perform well in its cancer centre management
business with positive profit and cash flow
contributions. Focused on growth, Aptium
Oncology continued to invest in sales and
marketing. The resulting expansion of its
consultancy business is creating new
opportunities for management relationships
in new markets in the US, with growing
interest from international sources.
Clinical research is an integral part of care
delivery at Aptium Oncology’s affiliated
cancer centres. In 2008, the company
established the Aptium Oncology GI Cancer
Consortium, bringing together eight leading
US academic institutions that will collaborate
to speed the process of finding and testing
active new compounds for patients with
gastrointestinal cancers.
OTHER BUSINESSES
DIREcTORS’ REpORT
71
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
ENVIRONMENTAL SUSTAINABILITY
In this section, we describe our commitment in
two key areas of environmental sustainability:
managing our carbon footprint and
understanding the potential impact of
pharmaceuticals in the environment. More
information about our work in these areas
and others, such as waste management,
resource efficiency, biodiversity and emissions
to air and water, can be found on our website,
astrazeneca.com/responsibility.
We continue to track, actively participate in,
and pursue initiatives relating to international
research and policy developments associated
with emerging safety, health and environment
(SHE) policy and legislative matters.
ClImATE CHANGE
We are committed to minimising our impact on
climate change and in recent years we have
been making good progress in reducing our
greenhouse gas emissions. In 2008 our total
emissions from all sources were 5% lower
than in 2007. Data on our performance over
the last three years is provided on page 15.
In common with most businesses, our
emissions arise from the energy we use at
our facilities, from other in-house activities
and from the various means of transport we
use. Our carbon footprint is also affected by
some of our respiratory therapies, specifically
our pressurised metered dose inhaler (pMDI)
products which rely on propellants such as
hydrofluoroalkane (HFA, a greenhouse gas),
to deliver the medicine to the airways. Patients
who are unable to use our Turbuhaler dry
powder inhaler, which does not require
propellants, need these pMDI products.
We believe that the expanded treatment choice
and potential benefits that they offer outweigh
the potential impact on the environment.
The business of developing, manufacturing
and distributing innovative medicines is
increasingly complex and uses energy both
in our facilities and in travel and transport.
We continue to drive the implementation of
initiatives and programmes that are focused
on managing our carbon footprint across key
areas of our business activity. For example,
recognising the significant global warming
emissions from business road travel for sales
and marketing activities, we continue to invest
in advanced driver training to improve both
safety and efficiency associated with road
travel and we are increasingly using a range
of hybrid and alternative fuel vehicles.
Other areas in which we are driving further
improvement include:
Implementation of green technology >
principles in our process design.
Exploring the potential for further >
investment in low carbon and renewable
energy options at our sites.
Further investment in greener energy >
supply from external power suppliers.
Implementation of further energy >
conservation programmes, particularly
related to fume cupboards in laboratories.
Alongside this, we also continuously seek to
use external opportunities to share learning
and foster best practice. For example, as part
of prioritising the selection of goods transport
partners on the basis of their reliability, quality
and internal safety, health and environmental
management, we take into consideration
the efficiency of their air and road fleets.
In 2008, AstraZeneca, in conjunction with our
European road freight and logistics provider,
was recognised in the European Outsourcing
Awards for the success of a new initiative to
co-load our product into vehicles with product
from other companies – minimising vacant
space and significantly reducing costs and
environmental impact.
ouR TARGETS
We continue to work hard to manage our
environmental impact without compromising
our ability to deliver new therapies for important
areas of healthcare. Our current climate change
targets, approved by the Board in 2005, aim
to ensure that our absolute emissions in 2010
will be no greater than they were at the start
of the decade and 55% less than they were
in 1990.
This requires substantial efforts to be made
across our business to produce, by 2010,
an absolute reduction of 12% in global
warming emissions from all sources other
than pMDIs, when compared with 2005.
More details about our reduction targets and
performance can be found on our website,
astrazeneca.com/responsibility.
We are currently in the process of developing
a new environmental sustainability strategy,
together with associated objectives and
targets, which will take us beyond 2010
and drive our continued commitment in this
important area.
pHARmACEuTICAlS IN THE ENVIRoNmENT
The presence of trace amounts of
pharmaceuticals in the environment (PIE)
resulting from patient excretion is an inevitable
result of the way most current medicines work:
pharmaceuticals need to be stable enough
to have a useful shelf life and oral dosage
forms must be robust enough, in most cases,
to pass through the stomach intact.
Continued publication of data relating to
the presence of pharmaceutical residues
in surface waters and more recently also
in drinking water has stimulated a wider
debate. We understand the concerns these
publications raise and are committed to
addressing this issue responsibly.
Whilst the scientific studies published to date
suggest that the low levels of pharmaceuticals
detected in the environment are unlikely
to pose a risk to human health, we continue
to develop a better understanding of the
potential long-term effects on aquatic life.
We are committed to ensuring that any
potential adverse effects are responsibly
balanced against the benefits our medicines
bring to patients.
This is an ongoing priority for our scientists
at our Environmental Laboratory in Brixham,
UK, who are at the forefront of this field of
science, working both independently and in
collaboration with other companies, leading
academics and regulatory bodies to advance
PIE-related research. We recently invested
$24 million in new laboratories at the Brixham
site to further improve the facilities for the
evaluation of the environmental fate and
persistence of pharmaceuticals.
The environmental profile of our new
pharmaceuticals is assessed prior to applying
for government approval in a manner that
is consistent with applicable regulatory
regimes. In addition, many of our existing
products are assessed to comply with the
new EU requirements in connection with post
approval applications.
We have also introduced internal Environmental
Risk Management Plans that will accompany
all new medicines and which will enable all
available environmental data for a product to
be taken into account at key decision points
during development.
51% SPONSORSHIP/HEALTHCARE
23% SPONSORSHIP/SCIENCE
AND EDUCATION
20% CHARITABLE SUPPORT
DONATIONS
6% OTHER
TOTAL SPEND: $72 MILLION
(EXCLUDING PRODUCT DONATIONS)
72
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
IN THE GLOBAL cOMMUNITY
dEdICATEd RESEARCH
We have a dedicated scientific resource in
Bangalore, India that focuses on finding a new,
improved treatment for TB – a major cause
of illness and death worldwide, especially
in Asia and Africa. AstraZeneca is the
only major pharmaceutical company with
a research programme in India totally
dedicated to TB. Further information can
be found in the Infection section on page 59.
WoRKING IN pARTNERSHIp
As well as the availability of appropriate
medicines, effective healthcare depends
on having a functional healthcare system in
place that ensures medicines are used to full
effect as part of overall health management.
In some parts of the developing world, this
is a particular challenge. To help meet this
challenge, we continue to partner with
NGOs and other organisations working
with local communities to strengthen their
healthcare capabilities.
Key principles for these partnerships are that
they lead to positive measurable outcomes,
can be scaled up and potentially replicated to
improve outcomes for a greater number, and
can deliver a sustainable framework that can
ultimately be owned and managed locally
without the need for our continued support.
We also aim to ensure that such partnerships
can contribute to AstraZeneca’s business
development, by enabling us to understand
better the health needs, and build important
relationships in future markets.
Our long-standing partnership with the
British Red Cross and Red Crescent
Societies includes support to programmes
in Central Asia that are helping to combat
TB and improve the quality of life of people
living with TB and TB/HIV co-infection in the
hard-hit areas of Turkmenistan, Kyrgyzstan
and Kazakhstan. Work is community-based
and progress to date includes over 7,500
people successfully completing their TB
treatment, with treatment completion rates
exceeding 90% among the most poor and
vulnerable, and public awareness campaigns
that have reached over one million people.
Overall, this work is contributing to the
implementation of national programmes that
are leading to a stabilisation and reduction in
the incidence of TB in these countries.
Wherever AstraZeneca is located worldwide,
we aim to make a positive contribution to
our local communities through charitable
donations, sponsorships and other initiatives
that help to make a difference. Our activities
focus on bringing sustainable benefit in
ways that are consistent with our business
of improving health and quality of life, and
on promoting the value of science among
young people.
In 2008, we spent a total of $718 million
(2007: $588 million) on community
sponsorships and charitable donations
worldwide, including $646 million of product
donations, valued at average wholesale
prices (2007: $518 million).
We also contribute where possible to disaster
relief efforts. During 2008, following the
earthquake tragedy in China, we committed
a total of $2 million to the immediate relief
effort and to a longer-term programme
designed to help the affected communities
rebuild their lives. Following the devastating
cyclone in Myanmar (Burma), we committed
a further $200,000 to increase Red Cross
emergency relief stocks held in the charity’s
regional Disaster Response Centre in Kuala
Lumpur, which was originally established
with $700,000 of funding from AstraZeneca
in 2005.
IN THE dEVElopING WoRld
Whilst we remain committed to making
a contribution to improving healthcare in
the developing world, we believe that real
progress can only be made through the
commitment of all the related stakeholders,
including governments, non-governmental
organisations (NGOs) and the international
community, as well as the private sector.
The medicines in our range today are not
relevant to the treatment of tuberculosis (TB),
HIV/AIDS and malaria, the most significant
healthcare problems that many developing
world countries are currently facing, but
we are applying our skills and resources to
helping in other ways.
Consistent with our overall commitment
to product stewardship and sustainable
production, AstraZeneca manufactures its
products in accordance with strict regulatory
requirements and our processes are designed
to avoid, or otherwise minimise, the loss of
product to the environment. We will continue
to proactively manage emissions of active
pharmaceutical ingredients from manufacturing
activities, integrate “green chemistry” principles
into our operations, and otherwise ensure
that any residual losses of pharmaceuticals
to the environment that do occur are at
levels that would be unlikely to pose a threat
to human health or the environment.
We make our environmental risk data, together
with available information on our existing
products, publicly available via the Swedish
Doctors Prescribing Guide website using the
voluntary disclosure system introduced by the
Swedish Association of the Pharmaceutical
Industry (LIF). The system was developed by
LIF and a number of Swedish stakeholders,
in conjunction with expert representatives
from international pharmaceutical companies,
convened and chaired by AstraZeneca.
We are also working with the Association of
the British Pharmaceutical Industry, to help
the Environment Agency for England and
Wales to evaluate the risks of the existing
medicines on their priority action list.
We continue to be active in communicating
and discussing our research and initiatives
at international and national conferences
with academia and other stakeholders.
We also participate in informal networks and
are active in proposing topics of interest for
discussion at scientific conferences and with
non-governmental organisations.
2008 CommuNITY SuppoRT
DIREcTORS’ REpORT
73
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
ENGAGING AT AN INTERNATIoNAl lEVEl
As part of our focus on TB, we actively
engage in international efforts to help in the
fight against this devastating disease. In some
cases, our external collaboration specifically
supports our own research effort by providing
opportunities for gaining valuable external
input and sharing of best practice.
During 2008, we helped fund and participated
in the third Open Forum on Key Issues in TB
Drug Development, organised by the Bill and
Melinda Gates Foundation, the Global Alliance
for TB Drug Development, Treatment Action
Group and the Stop TB Partnership Working
Group on New Drugs. The meetings are
designed to bring together TB drug developers,
regulators and other interested stakeholders,
such as TB care providers, public health
policy-makers, and community advocates.
The agenda is focused on addressing key
issues in the discovery, development and
registration of new TB treatments.
We also stepped up our involvement with the
Stop TB Partnership during 2008. AstraZeneca
is now a member of its International Board,
which provides leadership and direction and
monitors the implementation of agreed
policies and plans.
Our partnership with the African Medical and
Research Foundation (AMREF) is focused
on developing a model for the integrated
management of TB, HIV/AIDS and malaria at
both national and local levels in Uganda, where
there is high incidence of all three diseases.
This integrated management approach has not
been widely addressed previously and we are
one of the few organisations involved in such
work. A pilot programme is now underway
in the high incidence areas of Luwero and
Kiboga districts of central Uganda. Progress
includes increased detection rates (from 59%
in March to 73% in June in the Luwero district)
and the training of village health teams in
14 villages. Work with the district health
teams is also delivering better health planning
and co-ordination.
In Ethiopia, our partnership with Axios is
focused on building local capability in managing
breast cancer – the second most common
cancer among young women in that country.
The project has focused on strengthening
diagnosis and treatment capabilities, including
the creation of previously unavailable treatment
protocols and standardised reporting
guidelines for use across the country.
Our support to Voluntary Service Overseas
(VSO) includes the secondment of a senior
manager to the organisation to help them
further develop their strategy and framework
for delivering their health goals. We also
fund VSO volunteers working to build local
healthcare capabilities in underserved
communities across Africa and Asia. Alongside
this, we are enabling our employees to
volunteer for placements in appropriate
countries to support VSO, drawing on the
broad range of skills they can offer in human
resources, finance, IT and communications,
as well as health and medicine.
More information about these partnerships and
our other activities worldwide is available on
our website, astrazeneca.com/responsibility.
OVERSIGHT OF RISK MANAGEMENT AND ASSURANCE PROCESSES
Board and Audit Committee
MANAGEMENT OF RISKS
Line management within relevant business areas and functions
RISK ASSURANCE PROCESSES
Global Compliance and the Finance Function provides global oversight and co-ordination.
SET area compliance officers and specialist compliance functions provide
agreed monitoring and assurance processes within the business.
Group Internal Audit provides independent assurance and advice in areas
agreed with the Audit Committee and the SET in its annual plan.
MONITORING AND REVIEW OF RISK MANAGEMENT AND ASSURANCE PROCESSES
Senior Executive Team with delegation as considered appropriate within the Group
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ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
mANAGING RISK, pRINCIpAl RISKS
ANd uNCERTAINTIES
As a global, research-based pharmaceutical
company, we face a diverse range of risks
and uncertainties that may adversely affect
our business.
We work continuously to ensure that we
have effective processes in place for
identifying, assessing and managing these
risks appropriately, in line with our strategic
objectives, the material needs of our
stakeholders and our core values. As part
of this, we continue to monitor our business
activities and our external and internal
environments for new and emerging risks,
including environmental, social and governance
matters, to ensure that these are captured
and managed at the appropriate level.
In this section we describe our key risk
management and assurance mechanisms,
together with the associated accountabilities
and the principal areas of risks and
uncertainties that we currently consider to
be material to our business in that they may
have a significant effect on our financial
condition, results of operations and/or
reputation. Where relevant, specific risks
and uncertainties are also discussed at
various points in the Directors’ Report.
EmBEddEd IN BuSINESS pRoCESSES
Risk is an inherent part of doing business,
and our approach to risk management is
designed to encourage clear decisions on
which risks we should take and to provide
assurance that the commercial, financial,
compliance and reputation implications of
these risks are adequately understood and
managed to an acceptable level.
We constantly strive to ensure that risk
management is embedded within our existing
business processes and performance
management processes. The Group maintains
a long-term business plan, updated annually, to
support the delivery of its strategy. Each Senior
Executive Team (SET) area and key functions
are required to provide a comprehensive
assessment of their risks as part of the annual
business plan update. The Chief Executive
Officer and the Chief Financial Officer
undertake quarterly business reviews (QBRs)
with each SET area at which the key risks are
reviewed. To support this review, key functions
within each SET area are required to provide
quarterly updates on their key risks.
Our Code of Conduct and Global Policy
framework require all employees to maintain
consistent standards of responsible behaviour.
Compliance with the Code of Conduct, the
related policies and standards is mandatory.
Employees are encouraged to raise questions
about how to apply these standards and to
report suspected breaches and incidents
of non-compliance through our continuous
assurance process or the AZethics line and
other reporting channels described in the
Code of Conduct. Compliance with mandatory
standards is also subject to ongoing monitoring
and review by our compliance functions and
Group Internal Audit (GIA), in accordance
with its annual plan, agreed with the SET
and the Audit Committee.
To strengthen further our high-level corporate
responsibility (CR) management capability,
during late 2007/early 2008 we established
a dedicated Global CR Team of experienced
CR professionals from around the Group.
The Global CR Team leads the development
of our CR strategy and the alignment of
tactical delivery, working closely with Global
Compliance to ensure that the CR risks and
opportunities are identified and managed
appropriately, in line with business objectives.
In early 2009, we developed a combined
Compliance and Corporate Responsibility
‘Responsible Business’ scorecard with defined
objectives and accountabilities, to track
performance consistently across all SET
areas and enable quarterly reporting to SET,
the Audit Committee and Professor Dame
Nancy Rothwell (the Non-Executive Director
with responsibility for overseeing CR within
the Company), as well as annual reporting to
the Board and SET. We plan to introduce this
new scorecard during 2009.
KEY ACCouNTABIlITIES
The Board, and specifically the Audit
Committee, are accountable for monitoring
and overseeing the risk management
systems and processes implemented by
management and for assessing their
adequacy and effectiveness. In addition to
direct assurances from senior management
through the performance management and
monitoring process, they receive and review
a Group-level risk summary from the annual
business planning process and QBRs. They
also receive quarterly incident reports and
updates on compliance initiatives from the
Global Compliance Officer, and information
in respect of audits in relation to certain risks,
carried out by GIA, in accordance with its
annual audit plan.
SET members are accountable for ensuring
sound risk management, control and
assurance processes within their SET areas.
They actively participate in the annual and
quarterly risk review processes and receive
quarterly reports on key compliance incidents
and the outcomes of audits in their SET area.
They are also required to complete an annual
assurance statement to confirm that effective
risk management and control processes
have been operating throughout the year.
Line and project management are accountable
for the management of risk within the context
of their functional or cross-functional remit or
project. To support and underpin the work of
line and project management and the SET in
managing risk, we have developed systems
and processes to ensure the effective
identification, management and reporting of
key risks. A risk management policy, with
guidelines and supporting tools ensures that
managers can recognise, assess and actively
manage the challenges in their areas.
RISK
RISK mANAGEmENT & ASSuRANCE pRoCESSES
DIREcTORS’ REpORT
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ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
Our compliance organisation is comprised of
a wide range of specialist groups who work
with line management and the SET to develop
systems and processes for managing risk
in specific regulated areas to ensure ongoing
legal and regulatory compliance. These
groups include Good Laboratory, Clinical and
Manufacturing Compliance, SHE, Medical
and Regulatory Affairs, Financial Control and
Compliance, Information Security and Data
Privacy, Sales and Marketing Compliance
and Legal and Intellectual Property.
Both line management and these specialist
functions are supported by the Global
Compliance function that acts as the primary
reporting channel to Board and SET on
compliance matters and is accountable for
overseeing compliance globally and managing
the Group’s compliance programme.
Against the background of the key
accountabilities set out in this section,
the Board believes that adequate information
was made available to it in order to identify
the key risks and uncertainties facing the
business, further information of which is set
out in the Principal Risks and Uncertainties
section on page 76.
KEY CommITTEES ANd CouNCIlS
Our quarterly business review process serves
as the primary mechanism for monitoring
the effectiveness of business performance
and risk management and is embedded
into existing management team meetings.
In addition to this we operate a number of
management committees and councils to
monitor Group-wide compliance and reputation
risks including the Global Compliance
Committee (GCC) (further details of which
can be found in the Compliance and Group
Internal Audit section on page 93) and the
Issues Management Council (IMC).
The IMC monitors our external environment
for new and emerging issues relating to
our business that affect or concern our
stakeholders and works with the people
who are responsible for managing the issues
internally to agree appropriate actions,
timelines and, where possible, key performance
indicators. The Vice-President, Group Public
Affairs chairs the IMC and is also a member
of the GCC to ensure that any reputational
risk is fully captured at the appropriate level.
BuSINESS RESIlIENCE plANS
Our approach to risk management includes
the development of business resilience plans,
and such plans are designed to provide for
situations in which specific risks have the
potential to have a severe impact on our
business. During 2008, our business resilience
planning activities focused on improving
our existing crisis management processes,
planning and response structures, including
plans, escalation processes and crisis
communications. A global standard for crisis
management has been rolled out during 2008,
and during 2009 a global policy for business
resilience, to cover crisis management,
business continuity and emergency response
will be communicated. This will ensure
alignment of documentation, appropriate
training of line managers and the use of crisis
simulation activities to test the new procedures.
WoRKING WITH SupplIERS
We believe that effective risk management
extends to managing any potential reputational
risks associated with our purchasing activities.
We are therefore committed to working only
with those suppliers who embrace standards
of ethical behaviour consistent with our own.
This applies across the full range of our
purchasing activities, from promotional items
to pharmaceutical ingredients, and includes any
specialised work for which we use external
contractors to complement our in-house
effort. It also applies as much to our expanding
business in Emerging Markets as it does to
our existing supplier relationships.
We are in the process of revising and
strengthening our Corporate Responsibility
Principles in Purchasing, which we first
launched in 2003 to provide guidance
for our purchasing community on integrating
CR considerations into their activity.
The strengthened guidance will become
a new Global Responsible Procurement
Standard and will provide the framework for
developing and implementing the programmes
needed to ensure that we effectively and
consistently incorporate our standards of
ethical behaviour into our procurement activity
worldwide. Launch of the new standard is
planned for the first half of 2009 and targeted
training will be subsequently provided.
A rolling implementation
Integrating responsible business considerations
into all of our supplier relationships around
the world will take time. CR considerations
are being included in all new contracts and
master agreements in the US, the UK and
Sweden – our three main business hubs
where over 80% of our suppliers are based,
and last year we extended the geographic
reach to other countries where we have
major marketing, manufacturing or research
activities. These include Japan, China, India,
Canada, Mexico and Puerto Rico, as well as
more countries in Europe.
Monitoring performance
Our supplier evaluation procedure requires
that comprehensive on-site audits of all our
high-risk category suppliers be conducted
at least once every four years. Medium risk
suppliers are audited at the start of the
business relationship and refresher audits are
planned if there are any significant changes
at the supplier. The auditing process will
be further extended to regional and local
suppliers in 2009.
In 2008, our audit programme covered 28
manufacturing sites at 27 different global
suppliers. These audits included elements
of safety, health, environment, corporate
responsibility and security of supply. High-risk
categories such as active pharmaceutical
ingredients, formulation and packaging, and
complex chemicals were a particular focus.
Within the scope of the audit programme,
a critical deficiency in a known high risk
R&D-area (hydrogenation) was identified at a
proposed supplier. The supplier acknowledged
the audit feedback, de-commissioned the
facility and replaced it with a facility of an
appropriate standard.
During the year, we updated our supplier
evaluation process to include product security,
comprising elements such as information
security, logistics and waste handling related
to packaging operations. We have also
strengthened the social elements of the
evaluation process in recent years, particularly
in relation to human rights and labour
standards, given our expanding presence
in Emerging Markets.
Audit training continued during the year,
with nine more people joining the audit team.
We also conducted a focused ‘Ethical Auditing’
auditor-training programme as a part of the
implementation of the new supplier evaluation
process. Training will continue during 2009.
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ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
competing products to the market earlier
than they would have been able to, had the
patent protection been available.
Combined with patent protection and other
types of marketing exclusivity, products
protected by a valid trademark usually
generate higher revenues than those without
a trademark. We believe that we have robust
trademark protection for our products but
cannot be certain that we would be able
to defend any challenge successfully.
Expiration or earlier loss of patents
covering competing products
The expiration or earlier loss of patents
covering others’ branded products may lead
to the availability of generic products earlier
than anticipated, which could have a materially
adverse effect on our financial condition and
results of operations. For example, the loss/
expiry of patent rights covering major products
in the US, such as Lipitor
or Advair Diskus
after 2012 may adversely affect growth of our
still patented products in that market.
Failure to obtain patent protection
Our policy is to protect our investment in
R&D by applying for appropriate intellectual
property protection in respect of our inventions
and innovations; this is a key business priority.
Our ability to obtain patents and other
proprietary rights in relation to our products is,
therefore, an important element of our ability
to create long-term value for the business.
Many of the different countries in which we
operate are developing their patent laws for
pharmaceuticals and there is more uncertainty
regarding the patent protection available now
and in the future than in countries with well
developed intellectual property regimes.
Limitations on the availability of patent
protection in certain developing countries
could have an adverse effect on the pricing
and sales of our products and, consequently,
could adversely affect our revenues from
them. More information about protecting
our intellectual property is contained in the
Intellectual Property section on page 26.
Impact of fluctuations in exchange rates
As a global business, currency fluctuations
can significantly affect our results of operations,
which are accounted for in US dollars.
Approximately 47% of our 2008 sales were
in North America (US and Canada) with a
significant proportion of that figure being in
respect of US sales, which is expected to
remain our largest single market. Sales in
certain other countries are also in US dollars,
or in currencies whose exchange rates are
linked to the US dollar. Major components of
litigation relating to our products is described
in Note 25 to the Financial Statements.
In addition, the research-based pharmaceutical
industry may exert intellectual property rights
against other research-based companies
and there continues to be examples of this.
In the case of litigation both with generic
manufacturers and other research-based
companies, we expect that the greatest
challenges will be focused on the most
valuable products. Although we vigorously
defend our intellectual property rights we
cannot be certain we will be successful.
There is the risk that we may be found to
infringe the patents of others, and managing
such disputes can be costly. We may be
liable for damages or royalties, have to obtain
costly licences or stop manufacturing, using
or selling our products. This risk may be
greater in respect of biologics and vaccines
where intellectual property protection is
sometimes not so clear. In the event of such
risks arising we may mitigate them through,
for example, acquiring licences or making
modifications to cease the infringement and
permit commercialisation of our products.
Any of our currently patented products may
be the subject of intellectual property litigation
or other disputes involving patent offices,
anti-trust authorities, other government
or law enforcement agencies. Despite our
efforts to establish and defend robust patent
protection, we may not succeed in such
litigation or disputes or be able to mitigate the
risk through, for example: obtaining a licence
to any third party patent on commercially
reasonable terms; successfully developing
non-infringing alternatives on a timely basis;
or licensing alternative non-infringing
technology, if any exists, on commercially
reasonable terms. If we were not successful
during the patent protection or data
exclusivity periods in maintaining exclusive
rights to market one or more of our major
products, particularly in the US where we
have our highest revenue and margins, our
revenue and margins would be significantly
adversely affected.
In addition to the challenges to our patented
products from manufacturers of generic
or other patented pharmaceutical products,
there is a risk that some countries, particularly
some of those in the developing world, may
seek to impose limitations on the availability
of patent protection for pharmaceutical
products, or on the extent to which such
protection may be obtained and/or enforced,
within their jurisdictions. As a result, generic
manufacturers in these countries may be
increasingly and more easily able to introduce
pRINCIpAl RISKS ANd uNCERTAINTIES
The pharmaceutical sector is inherently risky
and a variety of risks and uncertainties may
affect our business. Here we summarise, under
the headings Industry/Economic Environment
Risks; Legal/Compliance/Regulatory Risks;
and Business Execution Risks, the principal
risks and uncertainties that we currently
consider may have a significant effect on our
financial condition, results of operations and/
or reputation. These risks are not listed in any
assumed order of priority. Other risks, unknown
or not currently considered material, could have
a similar effect. We believe the forward-looking
statements about AstraZeneca in this Report,
identified by words such as ‘anticipates’,
‘believes’, ‘expects’ and ‘intends’, are
based on reasonable assumptions. However,
forward-looking statements involve inherent
risks and uncertainties such as those
summarised below, and may be influenced
by factors beyond our control and/or may
have actual outcomes materially different
from our expectations.
INduSTRY/ECoNomIC ENVIRoNmENT RISKS
Expiration of patents or
marketing exclusivity
Pharmaceutical products or diagnostic or
medical devices are normally only protected
from competition from copying during the
period of patent protection or marketing
exclusivity. Following patent protection or
marketing exclusivity expiry the product is
generally open to competition from generic
copies. Products under patent protection or
having marketing exclusivity generally generate
significantly higher revenues than those not
protected by patents or marketing exclusivity.
Patent litigation and early loss of patents,
marketing exclusivity or trademarks
Generic drug manufacturers are seeking to
market generic versions of many of our more
important products, prior to the expiration of
our patents and marketing exclusivity periods.
For example, we are currently facing challenges
from multiple generic manufacturers to certain
of our patents for Nexium, Seroquel and
Crestor, some of our best-selling products
in the US, our largest market. If such
challenges are successful and generic
products are launched, or launched ‘at risk’
on the expectation that challenges to our
intellectual property will be successful, this
may have a materially adverse effect on our
financial condition and results of operations.
US sales for Nexium in 2008 were $3,101m,
for Seroquel were $3,015m and for Crestor
were $1,678m. The more significant patent
DIREcTORS’ REpORT
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ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
ratings agencies to review our credit rating,
with the potential to impact our ability to raise
debt to fund further externalisation.
Owning and operating a biologics
and vaccines business
As we continue to expand our biologics
capabilities, the risks related to owning and
operating a biological products business are
becoming more important to the Group.
Some of the more significant of these risks
are described below:
We may have limited access to and/or >
supply of biological materials, such as
cells or animal products or by-products.
In addition, government regulations in
multiple jurisdictions could result in
restricted access to, use or transport
of such materials. Loss of access to
sufficient sources of such materials,
or tighter restrictions on the use of such
materials may interrupt or prevent our
research activities as planned and/or
increase our costs.
The development, manufacturing and >
marketing of biological products are often
subject to more complex and stringent
regulations than those applicable to other
pharmaceutical products. As a result,
the production and release schedules
for biological products may be more
significantly affected by the regulatory
process than for other products.
In addition, various legislative and
regulatory authorities are considering
whether an abbreviated approval process
is appropriate for biosimilars or follow-on
biological products (similar versions of
existing biological products). It is uncertain
as to when, or if, any such process may
be adopted or how such a process
would relate to intellectual property rights
in connection with marketed or pipeline
biological products, but any such process
could have a material effect on the future
commercial prospects for patented
biological products.
Manufacturing biological products, >
especially in large quantities, is often
complex and may require the use of
innovative technologies to handle living
micro-organisms. Manufacturing biological
products requires facilities specifically
designed and validated for this purpose,
with sophisticated quality assurance and
quality control procedures. Slight deviations
in any part of the manufacturing process
may result in lot failure, product recalls or
spoilage, for example due to contamination.
Adverse impact of a sustained
economic downturn
A variety of significant risks may arise from
a sustained global economic downturn
including those referred to here. Additional
pressure from governments and other
healthcare payers on medicine prices and
volume of sales in response to recessionary
pressures on budgets may cause a slow
down or decline in growth in some markets.
In addition, suppliers of some of the key goods
and services we rely upon may cease to trade.
The consequence of this may be significant
delays and/or difficulties obtaining goods and
services on commercially acceptable terms
or even at all. We seek to mitigate these risks
as described in the Supply and Manufacturing
section on page 27.
Moreover, the high fixed costs of operating
a global research-based pharmaceuticals
business and the long and uncertain
development cycles for our products mean
that we are highly dependant on being able
to access a sustainable flow of liquid funds.
In a sustained and/or severe economic
downturn financial institutions who hold our
cash and other short-term deposits may cease
to trade and there can be no guarantee that
depositors/investors will be able to access
their assets without a protracted, expensive
and uncertain process, if at all. Although we
have adopted conservative cash management
and treasury policies to mitigate this risk
(further information of which is contained
in Financial Risk Management Policies on
pages 41 to 42) we cannot be certain
that these will be completely effective should
a number of major financial institutions cease
to trade. Additionally, if we need access to
external sources of financing to sustain and/or
grow our business, such as may be available
via the debt or capital financial markets,
this may not be available on commercially
acceptable terms, or at all, in the event of a
severe and/or sustained economic downturn.
A particular risk relates to the Groups pension
obligations, the single largest of which is
the UK Pension Fund. The obligations are
backed by assets invested across the broad
investment market. Sustained falls in these
assets will put a strain on funding resulting in
requirements for additional cash, which may
restrict our ability to grow the business in line
with our strategic objectives. Similarly, if the
liabilities rise, for example due to continued,
sustained improvements in longevity, or falls
in the corporate bond spreads that drive
discount rates for accounting valuations,
there will be a strain on funding. The likely
increase in the IAS19 accounting deficit
generated by any of these may cause the
our cost base are, however, located in Europe,
where an aggregate of approximately 51% of
our employees are based. Movements in the
exchange rates used to translate foreign
currencies into US dollars may, therefore,
have a materially adverse effect on our
financial condition and results of operations.
Certain of our subsidiaries import and export
goods and services in currencies other than
their own working currency. The results of such
subsidiaries could, therefore, be affected
by currency fluctuations arising between
the transaction dates and the settlement
dates for those transactions. We hedge these
exposures through financial instruments.
The fair value of financial instruments used to
hedge these exposures, principally forward
foreign exchange contracts, at 31 December
2008 was $95 million.
We have policies that seek to mitigate the
effect of exchange rate fluctuations on the
value of foreign currency cash flows and in
turn their effects on the results of the Group,
but we do not seek to remove all such risks.
Further information is contained in Financial
Risk Management Policies on pages 120 to
121. In general, a unilateral strengthening of
the US dollar adversely affects our reported
results whereas a weakening of the US dollar
is generally favourable.
Debt-funding arrangements
We incurred substantial debt in connection
with the acquisition of MedImmune, Inc..
Our debt could affect our business flexibility
and requires us to devote cash resources
to service interest and principal payments.
Our current debt level could limit our ability
to engage in additional transactions or incur
additional indebtedness and could potentially
affect our investment grade credit rating. Further
information is contained in Financial Risk
Management Policies on pages 41 to 42.
Bad debts
The Group sells to a large number of
customers, across many countries, ranging
from government backed agencies and
large private wholesalers to privately owned
pharmacies. An economic slowdown may
impact the ability of some of these customers
to continue to trade, which in turn may result
in losses from writing these debts off.
Although risk management processes are
in place to manage this risk, and provisions
are established for debts that may not be
recoverable we cannot be certain that there
will not be further losses above those already
provided for. Further information is contained
in the Financial Review on page 42.
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ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
the potential to affect our cash flows and
earnings per share. Claims, regardless of
their merits or their outcome, are costly, divert
management attention, and may adversely
affect our reputation.
The majority of the jurisdictions in which we
operate have double tax treaties with other
foreign jurisdictions, which enable us to
ensure that our revenues and capital gains do
not incur a double tax charge. If any of these
double tax treaties should be withdrawn or
amended, especially in a territory where a
member of the Group is involved in a taxation
dispute with a tax authority in relation to
cross-border transactions, such withdrawal or
amendment could have a materially adverse
effect on our financial condition and results of
operations, as could a negative outcome of a
tax dispute or failure of tax authorities to agree
through competent authority proceedings.
See the Financial Risk Management Policies
on pages 41 to 42 for further details of risk
mitigation. The Group is currently managing
a number of tax disputes detailed in Note 25
to the Financial Statements.
Substantial product liability claims
Given the widespread impact that prescription
drugs may have on the health of large
patient populations, pharmaceutical,
biopharmaceutical and medical device
companies have, historically, been subject
to large product liability damages claims,
settlements and awards for injuries allegedly
caused by the use of their products. Product
liability claims, regardless of their merits or
their outcome, are costly, divert management
attention, and may adversely affect our
reputation and demand for our products.
Adverse publicity relating to the safety of a
product or of other competing products may
increase the risk of product liability claims.
Litigation, particularly in the US, is inherently
unpredictable and verdicts and/or unexpectedly
high awards of damages can result. Substantial
product liability claims that result in court
decisions against us or in the settlement
of proceedings could have a materially
adverse effect on our financial condition and
results of operations, particularly where such
circumstances are not covered by insurance.
We are currently subject to extensive product
liability litigation in relation to Seroquel, and
further details about this and all material legal
proceedings in which we are involved are set
out in Note 25 to the Financial Statements.
Information about our approach to patient
safety is set out in the Medicines section on
page 16.
In the US realised prices are being depressed
through limited lists, or formularies, that
may force manufacturers either to reduce
prices or be excluded from the list, and as a
consequence lose sales revenue from patients
covered by that formulary. In addition, private
health insurance companies and employers
that self-insure increasingly require co-payments
from beneficiaries, particularly for branded
pharmaceuticals and biotechnology products,
among other reasons, to encourage
beneficiaries to use generic products.
The increased use of strict formularies by
institutional customers in response to the
current cost-containment environment and
increasingly restrictive reimbursement policies
could result in a materially adverse effect on
our financial condition and results of operations.
In the EU, efforts by the European Commission
to reduce inconsistencies and improve
standards and best practice in the disparate
national regulatory systems have met with little
immediate success. The industry is, therefore,
exposed to greater application of reference
pricing mechanisms and ad hoc national
cost-containment measures on prices and
the consequent cross-border movement of
products. The importation of pharmaceutical
products from countries where prices are low
due to government price controls or other
market dynamics, to countries where prices
for those products are higher, may increase.
The accession of additional countries from
Central and Eastern Europe to the EU as well
as economic changes within EU countries may
result in significant increases in the parallel
trading of pharmaceutical products. In the
US, new legislation is possible that may allow
the commercial importation of drugs into the
US from selected countries. The adoption of
such legislation could result in an increase in
volume of cross-border product movements
which could result in a materially adverse
effect on ournancial condition and results
of operations.
We expect that pressures on pricing will
continue and may increase. Because of
these pressures, there can be no certainty
that we will be able to charge prices for a
product that, in a particular country or in the
aggregate, enable us to earn an adequate
return on our investment in that product.
Taxation
The integrated nature of our worldwide
operations can produce conflicting claims
from revenue authorities as to the profits to be
taxed in individual territories. The resolution of
these disputes can result in a reallocation of
profits between jurisdictions and an increase
or decrease in related tax costs, and has
The methods of distributing and marketing >
biological products could have a material
impact on the revenue we are able to
generate from the sales of products
such as Synagis and FluMist.
The commercialisation of biologic
products is often more complex than
for traditional pharmaceutical products.
This is primarily due to differences in
mode of administration, technical
aspects of the product, and the rapidly
changing distribution and reimbursement
environments. The tools available to the
commercial team can be more limited
and time-consuming in that the target
physicians who prescribe biologics are
often hospital-based specialists who treat
patients with rare diseases. Biologics sales
forces are usually smaller, more targeted
and typically are required to make a more
detailed, data-driven sales call. Patient
education and awareness also requires
a more personalised approach in that
broad-based awareness campaigns, such
as direct-to-consumer advertising in the
US, is often not an efficient means by which
to reach a smaller target population.
Competition, price controls
and price reductions
Some of our most valuable products compete
directly with other products marketed either by
major R&D based prescription pharmaceutical
companies or by generic pharmaceutical
manufacturers. These competitors may
invest greater resources to the marketing of
their products than we do depending on the
relative priority of these competitor products
within their company’s portfolio. Generic
versions of products are often sold at lower
prices because they do not have to recoup
the significant cost of R&D investment, nor
do they generally invest the same amounts in
education services for healthcare professionals.
Industry consolidation has resulted in a small
number of very large companies, some of
which have acquired generic businesses.
This trend, if it continued, could adversely
affect our competitive position, whilst
consolidation among our customers may
increase price pressures. Some of our
patented products, including Nexium, Crestor,
Seroquel and Symbicort are subject to price
pressure from competition from generic
products in the same product class.
In most of our key markets there is continued
economic, regulatory and political pressure
to limit or reduce the cost of pharmaceutical
products. A summary of the principal aspects
of price regulation and how price pressures are
affecting our business in our most important
markets is set out in the Geographical Review
from page 48.
DIREcTORS’ REpORT
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ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
Public loss of confidence in the integrity
of pharmaceutical products as a result of
counterfeiting could adversely affect our
reputation and financial performance. In
addition, undue or misplaced concern about
the issue might induce some patients to stop
taking their medicines, with consequential
risks to their health.
We use a range of measures against
counterfeit medicines, and continue to develop
our capabilities in this area. These include
introducing technologies that make it more
difficult for counterfeiters to copy our products;
conducting market surveillance and monitoring
the supply chain to identify potential
counterfeiting operations; and responding
rapidly to any reports of counterfeit
AstraZeneca medicines, working with
regulators, healthcare professionals,
distributors, law enforcement agencies
and other organisations to protect patient
interests. We also participate in a variety of
anti-counterfeiting forums in the public and
private sector, including the WHO’s IMPACT
working group and the Pharmaceutical
Security Institute.
lEGAl/ComplIANCE/REGulAToRY RISKS
Adverse outcome of litigation and/or
government investigations and insufficient
insurance coverage
Note 25 to the Financial Statements includes
information about legal proceedings in which
we are currently involved. Unfavourable
resolution of these and similar future
proceedings, including government
investigations, competition and anti-trust
enquiries, investigations and litigation, product
liability litigation and securities class action
law suits, may have a materially adverse
effect on our financial condition and results
of operations, not least because we may be
required to make significant provisions in our
accounts related to legal proceedings and/or
governmental investigations, which would
reduce earnings. In many cases, particularly
in the US, the practice of the plaintiff bar is
to claim damages – compensatory, punitive
and statutory – in extremely high amounts.
Accordingly, it is difficult to quantify the
potential exposure to claims in proceedings
of the type referred to in Note 25 to the
Financial Statements.
Recent insurance loss experience in the
pharmaceutical industry, including product
liability exposures, has increased the cost
of, and narrowed the coverage afforded by,
pharmaceutical companies’ product liability
insurance. In order to contain insurance costs
in recent years, we have continued to adjust
our coverage profile, accepting a greater
degree of uninsured exposure. The Group
Nonetheless, a significant non-compliance
or incident for which we were responsible
could result in us being liable to pay
compensation, fines or remediation costs.
In some circumstances, such liability could
have a materially adverse effect on our
financial condition, reputation and results of
operations. In addition, our financial provisions
for any obligations that we may have relating
to environmental liabilities may be insufficient
if the assumptions underlying the provisions
– including our assumptions regarding the
portion of waste at a site for which we are
responsible – prove incorrect, or if we are
held responsible for additional contamination.
Developing our business
in emerging markets
The development of our business in emerging
markets may be a critical factor in determining
our future ability to sustain or increase the level
of our global product revenues. Challenges
that arise in relation to the development of
the business in emerging markets include,
but are not limited to, more volatile economic
conditions, competition from companies that
are already present in the market, the need
to identify correctly and leverage appropriate
opportunities for sales and marketing,
poor protection of intellectual property,
inadequate protection against crime
(including counterfeiting, corruption and
fraud) (further details of which can be found
below), inadvertent breaches of local law/
regulation and not being able to recruit
sufficient personnel with appropriate skills
and experience. The failure to exploit
potential opportunities appropriately in
emerging markets may have a materially
adverse effect on our financial condition and
results of operations. Information on the risks
associated with the failure to obtain patent
protection can be found above.
Product counterfeiting
Counterfeit medicines may contain harmful
substances, the wrong dose of the active
pharmaceutical ingredient (API) or no API at all.
Counterfeit medicines are a danger to patients
in all parts of the world; the International
Medical Products Anti-Counterfeiting Taskforce
(IMPACT) of the World Health Organization
(WHO) estimates that approximately 10%
to 30% of medicines in emerging economies
are counterfeit, with parts of Latin America,
Asia and Africa having a greater percentage
than that. By contrast, in developed countries
with effective regulatory systems, counterfeits
represent less than 1% of the market.
Performance of new products
Although we carry out numerous and extensive
clinical trials on all our products before they
are launched, for a new product it can be
difficult, for a period following its launch,
to establish from available data a complete
assessment of its eventual efficacy and/or
safety in broader clinical use on the market.
Due to the relatively short time that a product
has been tested and the relatively small
number of patients who have taken the
product, the available data may be immature.
Simple extrapolation of the data may not
be accurate and could lead to a misleading
interpretation of a new product’s likely future
commercial performance.
The successful launch of a new pharmaceutical
product involves a substantial investment in
sales and marketing costs, launch stocks
and other items. The commercial success of
our new medicines is of particular importance
to us in order to replace sales lost as and
when patent protection ceases in established
markets. If a new product does not succeed
as anticipated or its rate of sales growth is
slower than anticipated, there is a risk that
the costs incurred in launching it could have
a materially adverse effect on our financial
condition and results of operations. In addition,
for launch of products that are seasonal in
nature, delays for regulatory approval or
manufacturing difficulties can have the effect
of delaying launch to the next season and
significantly reduce the value of costs spent
in preparing for the launch for that season.
Environmental/occupational/health
and safety liabilities
We have environmental liabilities at some
currently or formerly owned, leased and third
party sites, as described in more detail in
Note 25 to the Financial Statements. These
liabilities are carefully managed by designated
technical, legal and business personnel
and there is no reason for us to believe that
associated current and expected expenditure
and/or risks are likely to have a materially
adverse effect on our financial condition and
results of operations as a general matter,
although they could, to the extent that they
exceed applicable provisions, have a materially
adverse effect on our financial condition and
results of operations for the relevant period.
In addition, a change in circumstances
(including a change in applicable laws or
regulations) may result in such an effect.
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ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
Inability to manufacture sufficient quantities >
of the product candidate for development
or commercialisation activities in a timely
and cost-efficient manner.
Unfavourable data from key studies. >
Excessive costs of, or difficulty >
in, manufacturing.
Erosion of patent term and other intellectual >
property rights, and infringement of those
rights and the intellectual property rights
owned by third parties.
Failure to show value or a differentiated >
profile for our products.
As a result, we cannot be certain that
compounds currently under development
will achieve success. There can also be no
guarantee that new products in the pipeline
will achieve market success or come to
market before the expiration of our patents
or the erosion of our current product brands.
Furthermore, a succession of negative
drug project results and a failure to reduce
development timelines effectively could
adversely affect the reputation of our R&D
capabilities. The failure of R&D to yield new
products that achieve commercial success
may have a materially adverse affect on our
financial condition and results of operations.
Acquisitions and strategic alliances
formed as part of our externalisation
strategy may be unsuccessful
We seek acquisitions of complementary
businesses, technology licensing
arrangements, strategic alliances and
collaborations to expand our product
portfolio and geographical presence as part
of our business strategy. Examples of such
recent strategic acquisitions, arrangements,
collaborations and alliances include:
Acquisition of MedImmune to accelerate >
our biologics capability.
Collaboration with Bristol-Myers Squibb >
Company to develop and commercialise
two investigational compounds being
studied for the treatment of Type 2
diabetes, saxagliptin and dapagliflozin.
Collaboration with POZEN Inc. to develop >
a fixed dose combination of enteric
coated naproxen and immediate release
esomeprazole for chronic pain (PN400),
utilising POZEN’s proprietary technology.
Failure to observe continuing
regulatory oversight
Once a product has been approved for
marketing by regulatory authorities, it is
subject to continuing control and regulation,
such as the manner of its manufacture,
distribution, marketing and safety surveillance.
In addition, the facilities in which products are
produced are subject to continuing inspections,
and minor changes in manufacturing
processes may require additional regulatory
approvals, either of which could result in us
having to incur significant additional costs.
Regulatory authorities have wide-ranging
administrative powers to deal with any failure
to comply with continuing regulatory oversight
(and this could affect us whether such failure
is our own or that of third parties with which
we have relationships). These powers include
withdrawal of a marketing approval previously
granted, product recalls, seizure of products,
closure of manufacturing sites and other
sanctions for non-compliance. Regulatory
sanction, following a failure to comply with
such continuing regulatory oversight, could
have a materially adverse effect on the conduct
of our business, our financial condition and
results of operations. In addition, because
our products are intended to promote the
health of patients, any supply interruption
could lead to allegations that public health
has been endangered, and could lead to
legal proceedings being filed against us,
damage to our reputation and loss of
confidence in our products.
BuSINESS EXECuTIoN RISKS
Challenges to achieving commercial
success of new products
The development of new products is complex
and involves the commitment of substantial
effort, funds and other R&D resources.
It involves a high degree of risk and uncertainty
and can take many years. New products are
important to replace the declining sales of
older products following expiry of intellectual
property protection. Our development of any
product candidate may fail at any stage
of the process, and we may ultimately be
unable to achieve commercial success for
any number of reasons, including:
Failure to obtain the required regulatory >
approvals for the product candidate or
the facilities in which it is manufactured.
Adverse reactions to the product >
candidate or indications of other
safety concerns.
has not held product liability insurance since
February 2006. In addition, where claims are
made under insurance policies, insurers
may reserve the right to deny coverage on
various grounds. If such denial of coverage is
ultimately upheld, this could result in material
additional charges to our earnings.
Difficulties of obtaining and maintaining
regulatory approvals for new products
We are subject to strict controls on the
manufacture, labelling, distribution and
marketing of pharmaceutical products.
The requirement to obtain regulatory approval
based on a product’s safety, efficacy and
quality before it may be marketed for a
specified therapeutic indication or indications
in a particular country, and to maintain and
to comply with licences and other regulations
relating to its manufacture, are particularly
important. The submission of an application
to regulatory authorities (which are different,
with different requirements, in each region or
country) may or may not lead to approval to
market the product. Regulators can refuse to
grant approval or may require additional data
before approval is given, even though the
medicine may already be launched in other
parts of the world. The countries that constitute
key markets for our pharmaceutical products
include the US, the countries of the EU and
Japan. The approval of a product is required
by the relevant regulatory authority in each
country, although a single pan-EU marketing
authorisation approval can be obtained
through a centralised procedure.
In recent years, regulatory authorities and
sponsor companies have been under increased
public pressure to apply more conservative
benefit/risk criteria before a pharmaceutical
product is approved. In addition, third party
interpretation of publicly available data on
our marketed products has the potential to
influence the approval status or labelling of
a currently approved and marketed product.
Further, predicting when a product will be
approved for marketing remains challenging.
For example, a review of the FDA performance
data indicates that for new drug and biologic
applications approved in 2008, the average
review time (ie the time from submission
to approval) increased markedly from 2007,
in part due to the FDA failing to meet the
review time targets for new drug applications
specified under the Prescription Drug User
Fee Act IV. Delays in regulatory reviews could
impact the timing of new product launch.
DIREcTORS’ REpORT
81
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
Delay to new product launches
Our continued success depends on the
development and successful launch of
innovative new drugs. The anticipated
launch dates of major new products have
a significant impact on a number of areas
of our business, including investment in large
clinical trials, the manufacture of pre-launch
stocks of the products, investment in
marketing materials ahead of a product
launch, sales force training and the timing
of anticipated future revenue streams from
commercial sales of new products. These
launch dates are primarily driven by the
development programmes that we run and
the demands of the regulatory authorities
in the approvals process, as well as pricing
negotiation in some countries. Delays in
anticipated launch dates can arise as a result
of adverse findings in pre-clinical or clinical
studies, regulatory demands, competitor
activity and technology transfer. Any delay
to the anticipated launch dates may therefore
impact our business and operations in a
number of ways. Significant delay to the
anticipated launch dates of new products
could have a materially adverse effect on our
financial condition and results of operations.
Failure of information technology
and outsourcing
We are dependent on effective information
technology (IT) systems. These systems
support key business functions such as our
R&D and manufacturing capabilities, and are
an important means of internal communication
and communication with customers and
suppliers. Any significant disruption of these
IT systems or the failure of new IT systems
to integrate with existing IT systems could
materially and adversely affect our operations.
We also have a number of outsourcing
arrangements in respect of critical processes,
services and the support of our IT infrastructure
and our increasing dependency on these
outsource providers could impact on our
ability to deliver on business targets and
to maintain our compliance status and
reputation. Risk associated with outsource
providers is mitigated by our contracting
approach which enables us to monitor closely
any degradation in services and enact staged
remedies. Our engagement of multiple
outsource providers mitigates against risk of
over-reliance on any one outsource provider.
systems and facilities, and personnel with
different organisational cultures. Integration
of an acquired business may also divert
management resources that would otherwise
be available for continuing development of
our existing business. The integration process
may result in business disruption, the loss of
key employees, slower execution of various
work processes, compliance failures due to a
change in applicable regulatory requirements
and other issues such as a failure to integrate
information technology and other systems
(further details of the risks associated with
information technology and outsourcing can
be found below).
Reliance on third parties for supplies
of materials and services
Like most, if not all, major research-based
pharmaceutical companies we increasingly
rely on third parties for the timely supply of
specified raw materials, equipment, contract
manufacturing, formulation or packaging
services and maintenance services that are
key to our operations. We actively manage
these third party relationships to ensure
continuity of supplies on time and to our
required specifications. However, events
beyond our control could result in the
delayed, incomplete or failure of supplies,
which could have a materially adverse effect
on our financial condition and results of
operations. Recently, we have established
sourcing centres in China and India to identify
high quality suppliers in those regions.
Further information is contained in the
Working with Suppliers section on page 75.
Failure to manage a crisis
We handle chemical and biological materials,
operate research and manufacturing plants
and distribute products worldwide. Major
disruption to our business and damage to our
reputation may be triggered by an operational
incident or actions by third parties. In these
circumstances, a plan for addressing
operational and other issues should ensure
a timely response and the ability to resume
business as usual. Failure to institute proper
communication to internal and external
stakeholders and mobilise a rapid operational
response could have a materially adverse
effect on our financial condition and results
of operations. Further information about our
business resilience plans and processes are
contained in the Business Resilience Plans
section on page 75.
Agreement with Abbott for the development >
of Abbott’s next-generation fenofibrate
(ABT-335) and Crestor in a single pill,
fixed-dose combination treatment to
target all three major blood lipids – LDL-C
‘bad cholesterol’, HDL-C ‘good cholesterol’
and triglycerides.
Collaboration deals with Columbia >
University and Newcastle University to
support our early stage discovery activities.
We may not complete these types of
transactions or collaborative projects in
a timely manner, on a cost-effective basis,
or at all, and may not realise the expected
benefits of any acquisition, licensing
arrangement or strategic alliance. Other
companies may also compete with us for
these opportunities. The success of such
current and future arrangements is largely
dependent on the technology and other
intellectual property we acquire and the
resources, efforts and skills of our partners.
Disputes and difficulties in such relationships
may arise, often due to conflicting priorities
or conflicts of interest which may erode or
eliminate the benefits of these alliances if,
for example, the agreements are terminated;
insufficient financial or other resources are
made available to the alliances; intellectual
property is negatively impacted; obligations
are not performed as expected; controls and
commercial limitations are imposed over the
marketing and promotion of products to be
co-developed; or challenges in achieving
commercial success of the product are
encountered during the development process.
Also, under many of our strategic alliances,
we make milestone payments well in advance
of commercialisation of products, with no
assurance that we will ever recoup those
payments. If these types of transactions are
unsuccessful, this may have an adverse
effect on our financial condition and results
of operations.
In addition, integration of an acquired business
could involve incurring significant debt and
unknown or contingent liabilities, as well
as having a negative effect on our reported
results of operations from acquisition-related
charges, amortisation of expenses related
to intangibles and charges for impairment of
long-term assets. These effects, individually
or in combination, could cause a deterioration
of our credit rating, increased borrowing
costs and interest expense. We could
also experience difficulties in integrating
geographically separated organisations,
82
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
Productivity initiatives
We are implementing various productivity
initiatives and restructuring programmes, with
the aim of enhancing the long-term efficiency
of the business. However, the anticipated
cost savings and other benefits are based on
preliminary estimates and the actual savings
may vary significantly. In particular, these cost
reduction measures are based on current
conditions and do not take into account
any future changes to the pharmaceutical
industry or our operations, including new
business developments, wage and price
increases and other factors. If inappropriately
managed the expected value of the initiative
can be lost through low employee morale
and hence productivity, increased absence
levels and industrial action. Our failure to
implement successfully these planned cost
reduction measures, either through the
successful conclusion of employee relations
processes (including consultation and
engagement, talent management and
recruitment and retention), or the possibility
that these efforts do not generate the level
of cost savings we anticipate, could have
a materially adverse effect on our financial
condition, results of operations and reputation.
See the People section on page 28 for
information about mitigating the risk of
significant business change.
8 INDEPENDENT
NON-EXECUTIVE DIRECTORS
1
3 EXECUTIVE DIRECTORS
2 NON-INDEPENDENT
NON-EXECUTIVE DIRECTORS
1
1 CHAIRMAN
11 MALE
3 FEMALE
5 0-3 YEARS
2 3-6 YEARS
4 6-9 YEARS
5 EUROPE
3 UK
3 US
BOARD OF DIRECTORS
Non-Executive Chairman and
Non-Executive Directors
Chief Executive Officer and other
Executive Directors
Board Committees
(Audit Committee,
Remuneration Committee,
Nomination & Governance Committee
and Science Committee)
Chief Executive Officer
Senior Executive Team
Senior Executive Team
R&D Executive Committee
Directors’ report
83
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
BUsiNess orGANisAtioN AND corporAte GoVerNANce
BuSINESS oRGANISATIoN
This section describes in broad terms how
the Company is organised in terms of the
overall structure and principal roles and
responsibilities of the Board, its committees
and other significant bodies such as the
Senior Executive Team (SET) and the R&D
Executive Committee.
ASTRAZENECA plC BoARd CompoSITIoN,
pRoCESSES ANd RESpoNSIBIlITIES
The Board comprises three Executive Directors
(two from April 2009 when John Patterson’s
retirement takes effect) and 11 Non-Executive
Directors. The membership of the Board at
31 December 2008, and information about
individual Directors is contained in the Board
of Directors section on pages 84 and 85.
All Directors are collectively responsible for the
success of the Company. The Non-Executive
Directors have a responsibility to bring
independent, objective judgement to bear on
Board decisions, which includes constructively
challenging management and helping to
develop the Company’s strategy as well as
scrutinising the performance of management.
The Non-Executive Directors also have
various responsibilities concerning the integrity
of financial information, internal controls and
risk management.
At the end of every Board meeting, the
Company’s Non-Executive Directors meet
without the Executive Directors present in
order to review and discuss any matters that
have arisen during the meeting and/or such
other matters as may appear to the Non-
Executive Directors to be relevant to them in
properly discharging their duties independently.
To ensure the Board has good visibility of the
key operating decisions of the business,
members of the SET routinely attend Board
meetings on a rotational basis and the Board
regularly meets and consults other senior
employees throughout the year.
BoARd ANd SENIoR mANAGEmENT
BAlANCE oF NoN-ExECuTIvE dIRECToRS
ANd ExECuTIvE dIRECToRS
GENdER SplIT
oF dIRECToRS
lENGTh oF TENuRE oF
NoN-ExECuTIvE dIRECToRS
GEoGRAphICAl mIx oF
NoN-ExECuTIvE dIRECToRS
1
As determined by the Board in accordance with the
UK Combined Code.
84
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
BoArD oF Directors At 31 DeceMBer 2008
louIS SChWEITZER (66)
Non-Executive Chairman,
Chairman of the Nomination
and Governance Committee and
Member of the Remuneration Committee
dAvId BRENNAN (55)
Executive Director and
Chief Executive Officer
SImoN loWTh (47)
Executive Director and
Chief Financial Officer
mARCuS WAllENBERG (52)
Non-Executive Director
JohN vARlEY (52)
Non-Executive Director,
Chairman of the Remuneration Committee
and Member of the Nomination and
Governance Committee
JohN BuChANAN (65)
Non-Executive Director,
Chairman of the Audit Committee and
Member of the Remuneration Committee
JohN pATTERSoN CBE FRCp (60)
Executive Director, Development and
Member of the Science Committee
hÅKAN moGREN KBE (64)
Non-Executive Deputy Chairman and
Member of the Nomination and
Governance Committee
mIChElE hoopER (57)
Senior Non-Executive Director,
Member of the Audit Committee and the
Nomination and Governance Committee
dAmE NANCY RoThWEll (53)
Non-Executive Director,
Chairman of the Science Committee and
Member of the Remuneration Committee
JANE hENNEY (61)
Non-Executive Director,
Member of the Audit Committee,
the Nomination and Governance
Committee and the Science Committee
Bo ANGElIN (59)
Non-Executive Director and
Member of the Science Committee
JEAN-phIlIppE CouRToIS (48)
Non-Executive Director and
Member of the Audit Committee
RudY mARKhAm (62)
Non-Executive Director and
Member of the Audit Committee
Other officers of the Company at 31 December
2008 included members of the Senior Executive
Team, as set out on page 86. John Patterson
will retire from the Board on 31 March 2009.
Adrian Kemp was appointed Company
Secretary with effect from 1 January 2009, in
succession to Graeme Musker who stepped
down at the end of 2008 and will retire from
the Company in April 2009.
Directors’ report
85
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
louIS SChWEITZER
Appointed as a Director 11 March 2004.
Non-Executive Chairman of Renault SA since
April 2005. Chairman and Chief Executive
Officer of Renault SA 1992-2005. Non-
Executive Director of BNP-Paribas, Veolia
Environnement, Volvo AB and L’Oréal.
dAvId BRENNAN
Appointed as a Director 14 March 2005.
Appointed Chief Executive Officer 1 January
2006. Chairman-elect of the Executive
Board of the Pharmaceutical Research and
Manufacturers of America (PhRMA) (to take
effect on 3 April 2009). Honorary Board
Member of the US CEO Roundtable on
Cancer, Board Member of the European
Federation For Pharmaceutical Industries
and Associations (EFPIA). Commissioner
of the UK Commission for Employment and
Skills (UKCES). Chairman of the Board of
the Southeastern Chapter of the American
Heart Association 2004-2006.
SImoN loWTh
Appointed as a Director 5 November 2007.
Also has overall responsibility for Information
Services. Finance Director, Scottish Power plc
2005-2007 and Executive Director, Corporate
Strategy and Development, Scottish Power
plc 2003-2005. Director – Head of UK
Industrial Practice, McKinsey & Company
2000-2003.
mARCuS WAllENBERG
Appointed as a Director 6 April 1999.
Formerly a Director of Astra AB (appointed
18 May 1989). Chairman of Skandinaviska
Enskilda Banken AB. Chairman of
AB Electrolux. Chairman of SAAB AB.
Vice-Chairman of Telefonaktiebolaget
L M Ericsson. Non-Executive Director of
Stora Enso Oyj, the Knut and Alice
Wallenberg Foundation and Temasek
Holdings Ltd. Honorary Chairman of
International Chamber of Commerce.
JohN vARlEY
Appointed as a Director 26 July 2006.
Executive Director of Barclays Bank plc and
Barclays plc since 1998 and Group Chief
Executive since 2004. Chairman of Business
Action on Homelessness and President of the
Employers’ Forum on Disability and member
of the International Advisory Panel of the
Monetary Authority of Singapore. Honorary
President of the UK Drug Policy Commission.
Treasurer and Trustee of St. Dunstan’s and
Trustee of Thornton Smith & Plevins Young
People’s Trust.
JohN BuChANAN
Appointed as a Director 25 April 2002.
Executive Director and Group Chief Financial
Officer of BP p.l.c. 1996-2002. Member of the
UK Accounting Standards Board 1997-2001.
Senior Independent Director of BHP Billiton Plc.
Deputy Chairman of Vodafone Group Plc.
Chairman of Smith & Nephew plc. Chairman
of International Chamber of Commerce (UK).
JohN pATTERSoN CBE FRCp
Appointed as a Director 1 January 2005.
Fellow of the Royal College of Physicians.
Director of the British Pharma Group.
Non-Executive Director of Cobham plc.
Non-Executive Director of Amersham plc
2001-2004. President of the Association
of the British Pharmaceutical Industry (ABPI)
2002-2004. Member of the Supervisory
Board of the UK Medicines Control Agency
1990-1994.
hÅKAN moGREN KBE
Appointed as a Director 6 April 1999.
Formerly Chief Executive Officer and a
Director of Astra AB (appointed 18 May 1988).
Member of the Board of Directors of Investor
AB and Groupe Danone. Director of the
Marianne and Marcus Wallenberg Foundation.
Member of the Royal Swedish Academy of
Engineering Sciences.
mIChElE hoopER
Appointed as a Director 1 July 2003.
President and Chief Executive Officer
of Stadtlander Drug Company 1998-1999.
Corporate Vice-President and President,
International Businesses of Caremark
International Inc. 1992-1998. Non-Executive
Director of UnitedHealth Group, PPG
Industries, Inc. and Warner Music Group, Inc.
dAmE NANCY RoThWEll
Appointed as a Director 27 April 2006.
Also has responsibility for overseeing
Corporate Responsibility.
MRC Research Professor and Deputy
President and Deputy Vice Chancellor at the
University of Manchester. Council member of
the Biotechnology and Biological Sciences
Research Council, Vice-President and
Council member of the Royal Society. Prior
appointments include: Trustee of Cancer
Research UK and the Campaign for Medical
Progress; Chair of the Research Defence
Society; Chair of the Wellcome Trust Public
Engagement Strategy Panel; President of the
British Neuroscience Association; and Council
member of the Medical Research Council.
JANE hENNEY
Appointed as a Director 24 September 2001.
Currently Professor of Medicine, University
of Cincinnati. Prior appointments include:
Senior Vice-President and Provost for Health
Affairs, University of Cincinnati Medical
Academic Health Center; Deputy Director,
US National Cancer Institute; Deputy
Commissioner for Operations, US Food and
Drug Administration (FDA); and Commissioner
of Food and Drugs, FDA. Non-Executive
Director of AmerisourceBergen Corporation
and CIGNA Corporation. Other board
appointments include The Commonwealth
Fund and China Medical Board.
Bo ANGElIN
Appointed as a Director 24 July 2007.
Professor of Clinical Metabolism at Karolinska
Institutet and Head of the Department of
Endocrinology, Metabolism and Diabetes
at the Karolinska University Hospital in
Stockholm, Sweden. Member of the Nobel
Assembly and of the Swedish Royal Academy
of Sciences. Member of the Medical Nobel
Institute. Prior appointments include Chairman
of the Nobel Committee for Physiology
and Medicine.
JEAN-phIlIppE CouRToIS
Appointed as a Director 18 February 2008.
President of Microsoft International since
June 2005. CEO Microsoft EMEA 2003-2005.
President Microsoft EMEA 2000-2003.
Corporate Vice-President, Microsoft
Worldwide Customer Marketing 1998-2000.
Administrator for PlaNet Finance and
representative at the Institut Montaigne.
RudY mARKhAm
Appointed as a Director 12 September 2008.
Chairman and Non-Executive Director of
Moorfields Eye Hospital Foundation Trust.
Non-Executive Director of United Parcel
Services Inc., Financial Reporting Council,
Standard Chartered PLC and Legal &
General plc. Fellow of the Chartered Institute
of Management Accountants and Fellow of
the Association of Corporate Treasurers.
86
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
cHieF eXecUtiVe oFFicer,
DeLeGAtioN oF AUtHoritY AND seNior eXecUtiVe teAM
NEW AppoINTmENTS EFFECTIvE FRom 1 JANuARY 2009
seNior eXecUtiVe teAM
dAvId BRENNAN
Chief Executive Officer
SImoN loWTh
Chief Financial Officer
ToNY ZooK
Chief Executive Officer, North America,
President, MedImmune and Executive
Vice-President, Global Marketing
dAvId SmITh
Executive Vice-President, Operations
lYNN TETRAulT
Executive Vice-President, Human
Resources and Corporate Affairs
JohN pATTERSoN
Executive Director, Development
BRuNo ANGElICI
Executive Vice-President, International
Sales and Marketing Organisation
JAN luNdBERG
Executive Vice-President, Discovery
Research
ANdERS EKBlom
Executive Vice-President, Development
JEFFREY poTT
General Counsel
Directors’ report
87
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
ChIEF ExECuTIvE oFFICER ANd dElEGATIoN
oF AuThoRITY
The Chief Executive Officer has been
delegated authority from, and is responsible to,
the Board of AstraZeneca PLC for directing
and promoting the profitable operation and
development of the Company, consistent
with the primary aim of enhancing long-term
shareholder value, in relation to all matters
save those which have been specifically
reserved for the Board.
The Chief Executive Officer is responsible
to the Board for the management and
performance of the Company’s business
within the framework of Company policies,
reserved powers and routine reporting
requirements. He is obliged to refer certain
major matters (defined in the formal delegation
of the Board’s authority) back to the Board.
The roles of the Board and the relationship
between each of the Board’s committees,
the Chairman, the Chief Executive Officer and
the Senior Executive Team are documented,
as are the Board’s delegated authorities and
reserved powers, the means of operation of the
business and the roles of corporate functions.
SENIoR ExECuTIvE TEAm (SET)
The Chief Executive Officer has established
and chairs the SET (pictured on page 86).
Although the Chief Executive Officer retains
full responsibility for the authority delegated
to him by the Board, the SET is the vehicle
through which he has chosen to exercise
certain of that authority in respect of the
Group’s business. The SET normally meets
once a month to consider and decide major
business issues. Typically, it also reviews those
matters that are of a size or importance to
require the attention of, or that are reserved to,
the Board before such matters are submitted
to the Board for review and decision.
John Patterson, Executive Director,
Development stepped down from his
operational position at the end of January
2009 and will retire from the Board on
31 March 2009.
Anders Ekblom was appointed Executive
Vice-President, Development and Jeffrey Pott
was appointed General Counsel, both with
effect from 1 January 2009 when they both
became members of the SET.
In July 2008, David Mott resigned from his
position as President and Chief Executive
Officer of MedImmune to pursue his
career outside AstraZeneca. Tony Zook was
appointed President of MedImmune with
effect from 13 November 2008, having held
the position of interim head of MedImmune
since David Mott’s resignation. Tony Zook
retains his other responsibilities as Chief
Executive Officer, North America and Executive
Vice-President, Global Marketing.
opERATIoN oF ThE BoARd oF dIRECToRS
The Board is responsible for the Company’s
corporate governance, sets the Company’s
strategy and policies and also monitors
progress towards meeting its objectives
and annual plans. The Board discharges
these responsibilities through a programme
of meetings that include a formal, annual
strategy review. The Board also assesses
whether or not and to what extent its
obligations to the Company’s shareholders and
others are understood and met. This includes
regular reviews of the Company’s financial
performance and critical business issues.
In the view of the Board, at least half of the
Board members are, for the purposes of the
UK Combined Code on Corporate Governance
and the corporate governance standards of
the New York Stock Exchange, independent
Non-Executive Directors.
Prior to the publication of this Report, the Board
conducted its annual review and assessment
of how it operates. This was facilitated through
a series of web-based questionnaires as
well as through interviews between each
of the Directors and an external facilitator.
These interviews included consideration
and discussion of the nature and level of its
interaction with the Company’s management;
the quality, quantity and scope of information
which flows to the Board from management,
and the way in which it flows; the content
of and presentations to Board meetings;
the composition of the Board; the practical
arrangements for the work of the Board;
and the work and operation of the Board’s
committees. Overall, it was concluded that
the Board and its committees were operating
in an effective and constructive manner.
As part of the assessment process the
external facilitator gave feedback to each
Non-Executive Director about his or her
individual performance. The Non-Executive
Directors reviewed the performance of the
Chief Executive Officer and other Executive
Directors in their absence. In addition,
the Board, under the chairmanship of the
Senior Independent Director, reviewed the
performance of the Chairman in his absence.
The Board maintains and regularly reviews
a full list of matters and decisions that are
reserved to, and can only be approved by,
the Board. These include the appointment,
termination and remuneration of any Director;
the annual budget; any item of fixed capital
expenditure or any proposal for the acquisition
or disposal of an investment or business
which exceeds $150 million; raising of capital
or loans by the Company (subject to certain
exceptions); any guarantee in respect of
any borrowing of the Company; and allotting
shares of the Company. The matters that
have not been expressly reserved to the
Board are either delegated to its committees
or to the Chief Executive Officer.
BoARd mATTERS
As part of the business of each meeting
of the Board, the Chief Executive Officer
typically submits a report on progress of
each key area of the business and detailing
progress against the goals the Board has
approved and their activities. The Board also
receives accounting and other management
information for the assessment of the
Company’s resources, presentations from
internal and external speakers on legal,
governance and regulatory developments
and external perspectives.
The Company Secretary is responsible to
the Chairman for ensuring that all Board
and Board committee meetings are properly
conducted, that the Directors receive
appropriate information prior to meetings to
enable them to make an effective contribution,
and that governance requirements are
considered and implemented.
The Board held six scheduled and two other
meetings in 2008. All of the Board meetings
were held in London or by telephone.
88
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
The Company has entered into a deed of
indemnity in favour of each Board member
since 2006. These deeds of indemnity are still
in force and provide that the Company shall
indemnify the Directors to the fullest extent
permitted by law and the Articles, in respect
of all losses arising out of, or in connection
with, the execution of their powers, duties
and responsibilities, as Directors of the
Company or any of its subsidiaries. This is in
line with current market practice and helps
the Company attract and retain high-quality
skilled Directors.
opERATIoN oF BoARd CommITTEES
The Board has delegated certain
responsibilities to the Audit, Remuneration,
Nomination and Governance, and Science
Committees. The Board provides adequate
resources to enable each committee to
undertake its duties. Each of the Audit,
Remuneration, and Nomination and
Governance Committees is made up of
Non-Executive Directors, although Executive
Directors may be invited to attend meetings.
Members of the Science Committee include
Executive Directors, Non-Executive Directors
and certain senior managers. However, this
Committee is purely advisory in nature.
Further details of the role, membership and
terms of reference for each committee are
set out below. In addition to the standing
committees of the Board, there may from
time to time be constituted ad hoc
committees for specific projects or tasks.
In these cases, the scope and responsibilities
of the committee is documented.
During 2008:
Jean-Philippe Courtois and Rudy Markham >
were appointed as Non-Executive
Directors on 18 February 2008 and
12 September 2008 respectively, in
accordance with Article 70 of the Articles.
On 4 November 2008, the Company >
announced that John Patterson will retire
from the Board on 31 March 2009.
Newly appointed Directors are provided with
comprehensive documentation, setting out their
obligations and duties as Directors. They also
typically attend tailored induction programmes
that take account of their individual skills and
experience. To develop an understanding of
the major shareholders’ views about the
Company, the Non-Executive Directors
(together with the rest of the Board) regularly
receive reports and presentations from the
Company’s brokers and meet with senior
managers throughout the year. Moreover the
Directors actively encourage shareholders to
attend the AGM and ask questions.
In accordance with Article 65 of the Articles, all
of the Directors will retire at the AGM in April
2009. The Notice of AGM will give details of
those Directors presenting themselves for
election or re-election at the AGM.
The Company maintained directors’ and
officers’ liability insurance cover throughout
2008. The Directors are also able to obtain
independent legal advice at the expense of
the Company, as necessary in their capacity
as Directors.
BoARd mEETING ATTENdANCE
Number of meetings attended/
(number of meetings Director
Name was eligible to attend in 2008)
Bo Angelin 8(8)
David Brennan 8(8)
John Buchanan 7(8)
Jean-Philippe Courtois
1
6(7)
Jane Henney 7(8)
Michele Hooper 8(8)
Simon Lowth 8(8)
Rudy Markham
2
3(3)
Håkan Mogren 5(8)
John Patterson
3
8(8)
Nancy Rothwell 6(8)
Louis Schweitzer 8(8)
John Varley 6(8)
Marcus Wallenberg 7(8)
1
Jean-Philippe Courtois was appointed on
18 February 2008 in accordance with the
Company’s Articles of Association.
2
Rudy Markham was appointed on 12 September
2008 in accordance with the Company’s Articles
of Association.
3
John Patterson will retire on 31 March 2009.
Given the nature of the business to be
conducted, some Board meetings are
convened at short notice, which occasionally
makes it difficult for some Directors to
attend due to prior commitments. In such
circumstances, the meeting will proceed as
scheduled provided it is quorate. The briefing
papers will still be sent to the absent Directors
who will typically give their comments and
feedback on the business to be discussed
at the meeting to the Chairman, to be raised
at the meeting.
The Board is currently scheduled to meet six
times in 2009, and will meet at such other
times as may be required to conduct business.
The Nomination and Governance Committee
(formerly the Nomination Committee)
recommends the appointment of new
Directors to the Board by an established
procedure. Appointments are based on the
merits of the candidates and the relevance of
their background and experience, measured
against objective criteria, with care taken to
ensure that appointees have enough time to
devote to the job. Further details of the type
of criteria used to select candidates are set
out in the Nomination and Governance
Committee section on page 91.
In accordance with the Companys Articles
of Association (Articles), all Directors retire at
each Annual General Meeting (AGM) and may
offer themselves for re-election by shareholders
(see below for more details). The Board
reviews annually the status of succession
to senior positions, including those at Board
level, and ensures it has regular contact with,
and access to, succession candidates.
BoARd CommITTEE mEmBERShIp
Nomination
Audit Remuneration and Governance Science
Name Committee Committee Committee Committee Independent
1
Bo Angelin x x x
David Brennan x x x x x
John Buchanan Chair
x x
Jean-Philippe Courtois
2
x x x
Jane Henney
x
Michele Hooper
3
x
x
Simon Lowth x x x x x
Rudy Markham
4
x x x
Håkan Mogren x x
x x
John Patterson x x x
x
Nancy Rothwell x
x Chair
Louis Schweitzer x
Chair x N/A
5
John Varley x Chair
x
Marcus Wallenberg x x x x x
1
As determined by the Board for UK Combined Code purposes.
2
Appointed 18 February 2008.
3
Michele Hooper is the Senior Non-Executive Director.
4
Appointed 12 September 2008.
5
For the purposes of the UK Combined Code (although determined by the Board to be independent on appointment).
Directors’ report
89
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
Corporate Finance & Insurance) monitors the
status of all services being provided by the
external auditor. The procedures also deal
with placing non-audit work out for tender,
where appropriate. Authority to approve
work in excess of the pre-agreed fee limits
is delegated to the Chairman of the Audit
Committee in the first instance. A standing
agenda item at Audit Committee meetings
covers the operation of the pre-approval
procedures and regular reports are provided
to the full Audit Committee.
The Audit Committee’s remit is available on
the Company’s website, astrazeneca.com.
The Audit Committee held four scheduled
meetings during 2008. All of these meetings
were held in London, UK. All Audit Committee
members participated in all meetings either
in person or by telephone, except John
Buchanan, who was absent from the meeting
on 29 January 2008.
Following each Audit Committee meeting,
the Chairman of the Committee (or the Senior
Non-Executive Director in the absence of the
Chairman of the Committee) reported to the
Board on the principal matters covered at the
meeting and minutes of the meetings were
circulated to all Board members.
Members of the Audit Committee met
individual managers or groups of managers
from the Company on a number of occasions
during 2008, which helped the Audit
Committee members gain a deeper insight
into areas relevant to the Audit Committees
work and provided an opportunity to discuss
specific areas of interest.
During the year, in line with its normal practice,
the Audit Committee also held a number
of private meetings, without management
present, with the Company’s Vice-President,
GIA, the Global Compliance Officer and the
lead partners from the Companys external
audit firm. The purpose of these meetings
was to facilitate free and open discussions
between the Audit Committee members and
those individuals, separately from the main
sessions of the Audit Committee, which were
attended by the Chief Financial Officer and
the Senior Vice-President, Group Finance.
During 2008 and January 2009, the business
considered and discussed by the Audit
Committee included the matters referred
to below:
The Company’s financial disclosures >
were reviewed and various accounting
matters considered.
The Company’s overall framework for >
internal control over financial reporting and
for other internal controls and processes.
The Company’s overall framework for risk >
management, particularly financial risks.
The accounting policies and practices of >
the Company.
The annual and quarterly financial >
reporting carried out by the Company.
The Audit Committee is charged with promptly
bringing to the attention of the Board any
significant concerns of the external auditor or
the Vice-President, GIA arising from their audit
work, any matters that may significantly affect
or impair the independence of the external
auditor, any significant deficiencies or material
weaknesses in the design or operation of
the Companys internal control over financial
reporting or other internal controls, and any
serious issues of non-compliance.
The Audit Committee oversees the
establishment, implementation and
maintenance of the Company’s Code
of Conduct and other related policies.
It establishes procedures for the receipt
and handling of complaints concerning
accounting or audit matters. It recommends
to the Board the appointment of the external
auditor, subject to the approval of the
Company’s shareholders at a general meeting.
Shareholders in a general meeting authorise
the Directors to fix the remuneration of the
external auditor. The Audit Committee reviews
and approves the appointment and any
dismissal of the Vice-President, GIA.
The Audit Committee maintains policies and
procedures for the pre-approval of all audit
services and permitted non-audit services
undertaken by the external auditor, the
principal purpose of which is to ensure that
the independence of the external auditor is
not impaired. The policies and procedures
cover three categories of work – audit services,
audit-related services and tax services.
The policies define the type of work that
falls within each of these categories and the
non-audit services that the external auditor is
prohibited from performing under the rules of
the US Securities and Exchange Commission
and other relevant UK professional and
regulatory requirements. The pre-approval
procedures permit certain audit, audit-related
and tax services to be performed by the
external auditor during the year, subject to
fee limits agreed with the Audit Committee in
advance. The Chief Financial Officer (supported
by the Senior Vice-President, Group Finance;
Vice-President, Global Benefits; and Director,
AudIT CommITTEE
“During the year, the Audit Committee
continued to review critical accounting
judgements and the quarterly financial
results. The Audit Committee considered
reports from senior management and
reviewed reports from key assurance
and governance functions within the
Group as part of its role of overseeing
how risk is managed. It explored with
management how they will continue to
deliver high-quality oversight, monitoring
and evaluation of risk against the
background of some significant changes,
both within the business and in the
external environment.
JohN BuChANAN
Chairman of the Audit Committee
The current members of the Audit Committee
are John Buchanan (Audit Committee
Chairman), Jane Henney, Michele Hooper
(the Senior Non-Executive Director),
Jean-Philippe Courtois (who joined on
18 February 2008) and Rudy Markham (who
joined on 12 September 2008). They are all
Non-Executive Directors. The Board considers
each member to be independent under the
UK Combined Code and under the general
guidance and specific criteria of the New
York Stock Exchange’s (NYSE) corporate
governance listing standards concerning the
composition of audit committees applicable
to non-US companies. In April 2008, the
Company submitted the required annual
written affirmation to the NYSE confirming
its full compliance with those standards. For
the purposes of the UK Combined Code,
the Board remains satisfied that at least one
member of the Audit Committee has recent
and relevantnancial experience. At its meeting
in December 2008, the Board determined
that Michele Hooper and Rudy Markham are
audit committee financial experts for the
purposes of the US Sarbanes-Oxley Act of
2002. The Deputy Company Secretary acts
as secretary to this committee.
The core remit of the Audit Committee includes
reviewing and reporting to the Board on:
Matters relating to the audit plans of >
the external auditor and Group Internal
Audit (GIA).
90
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
not include any contractual obligations under
which the Directors would be prevented from
appointing a different audit firm were they to
consider this to be in the best interests of the
Group. The Audit Committee, through
management, continues to maintain contact
and dialogue with other major audit firms
who are familiar with the Company’s business
for succession purposes as required. This is
reported to the Audit Committee in order to
ensure a smooth transition from the current
auditor, should this be necessary.
At the same meeting, the Chief Executive
Officer and the Chief Financial Officer
presented to the Audit Committee their
conclusions following the evaluation of the
effectiveness of the Company’s disclosure
controls and procedures required by Item
15(a) of Form 20-F as at 31 December 2008.
Based on their evaluation, the Chief
Executive Officer and the Chief Financial
Officer concluded that, as at that date, the
Company maintains an effective system of
disclosure controls and procedures.
There was no change in the Company’s
internal control over financial reporting
that occurred during the period covered
by this Annual Report and Form 20-F
Information 2008 that has materially affected,
or is reasonably likely to materially affect,
the Company’s internal control over
financial reporting.
The Audit Committee is currently scheduled
to meet four times in 2009 and will meet at
such other times as may be required.
REmuNERATIoN CommITTEE
The remit and role of the Remuneration
Committee is to consider, on behalf of the
Board, the remuneration (including pension
rights and compensation payments) of
Executive Directors, the Chairman and senior
executives. More information is set out in the
Executive Directors’ and Senior Executive
Team’s Remuneration and Terms of
Employment section within the Directors’
Remuneration Report on pages 174 to 188.
The information contained in the Directors’
Remuneration Report on pages 174 to 188
relating to the remit and members of the
Remuneration Committee during 2008, as
well as the independence of those members
and the number of meetings they attended
throughout the year, is incorporated by
reference into this Directors’ Report.
Other reports concerning the GIA, global >
compliance and financial compliance and
control and the global finance functions,
including the internal audit plan and
progress and plans of the Global
Compliance Officer.
The amount of audit and non-audit fees of >
the external auditor throughout 2008.
The Audit Committee was satisfied
throughout the year that the objectivity
and independence of the external auditor
were not in any way impaired by either the
nature of the non-audit work undertaken
by the external auditor during the year, the
level of non-audit fees charged for such
work or any other facts or circumstances.
Further information about the audit and
non-audit fees for the year is disclosed in
Note 27 to the Financial Statements on
page 163.
A review and assessment of the Audit >
Committee’s performance and it was
concluded that this was satisfactory.
In line with best practice, the Group will
periodically consider how the audit
requirements of the Group are best served in
the context of business need and the
prevailing external environment and, against
the background of this review, will from time
to time undertake a formal tendering
programme with audit firms of appropriate
size and calibre. Following discussions at a
meeting in January 2009, the Audit
Committee unanimously recommended to
the Board that a resolution for the re-
appointment of KPMG Audit Plc as the
Companys external auditor be proposed to
shareholders at the AGM in April 2009.
Based on its experience of working with
external auditors, the Audit Committee
believes that the quality of the interaction with
and level of service received from KPMG
Audit Plc were key factors supporting this
recommendation. The Audit Committee was
also satisfied that, notwithstanding the length
of tenure of KPMG Audit Plc, KPMG Audit
Plc met the independence criteria under the
relevant statutory, regulatory and accounting
standards. Consistent with current market
practice, KPMG Audit Plc’s services to the
Group are provided pursuant to terms of
engagement which are reviewed by the Audit
Committee. These terms of engagement do
Reports were received from the external >
auditor concerning its audit of the Financial
Statements of the Group and from
management, GIA, Global Compliance and
the external auditor on the effectiveness of
the Companys system of internal controls
and, in particular, its internal control over
financial reporting. This included review and
discussion of the results of the Company’s
‘continuous assurance’ and annual ‘letter
of assurance’ processes (described further
below in the UK Corporate Governance
Requirement section). The Audit Committee
also reviewed quarterly activity reports
of audit work carried out by GIA and
the status of follow-up actions with
management as well as reports from
the Global Compliance function.
The Company’s continuing work to comply >
with the applicable provisions of the US
Sarbanes-Oxley Act of 2002. In particular,
it regularly reviewed the status of compliance
with the programme of internal controls
over financial reporting implemented
pursuant to section 404 of the Act. Further
information about the implementation of
section 404 of the Act is set out in the
Financial Review on page 47.
A review of data about calls made by >
employees via the AZethics telephone
lines and other routes regarding potential
breaches of the Company’s Code of
Conduct together with the results of
enquiries into these matters. No material
issues were reported through this route
during the year.
The Audit Committee reviewed reports from >
the Vice-President, GIA on areas where
GIAs resources could most appropriately
be focused and where efficiency savings
could be achieved in the context of the
strengthening capabilities of the Global
Compliance function and the continued
work of the Financial Controls and
Compliance Group.
Reports from the Group Treasury Function >
and, in particular, considered the Group’s
liquidity and cash position and the
appropriateness of its cash management
policies in the context of the current
economic situation.
Directors’ report
91
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
To review, from time to time, together with >
other external experts important bioethical
issues faced by the Company and to
assist in the formulation of, and to agree
on behalf of the Board, appropriate
policies in relation to such issues.
To consider with external experts, from >
time to time, future trends in medical
science and technology.
The Science Committees remit is available on
the Company’s website, astrazeneca.com.
The Science Committee met twice in 2008
to review and discuss its remit and method
of operation, the Company’s Cardiovascular
and Neuroscience R&D, innovation with
R&D, emerging areas of science and its
science policy. Each member participated
in both meetings.
pRINCIpAl uK ANd
uS GovERNANCE REQuIREmENTS
uK CoRpoRATE GovERNANCE REQuIREmENTS
The Board has prepared this Report with
reference to the UK Combined Code on
Corporate Governance and related guidance
published in June 2006 by the Financial
Reporting Council. A new version of the UK
Combined Code was published in June 2008
and applies to accounting periods beginning
on or after 29 June 2008. The Board believes
that, were these standards to be applied with
respect to the current arrangements, it would
comply with the latest standards.
The Company is applying all the main and
supporting principles of good governance in
the UK Combined Code as described below.
The Company has complied throughout the
accounting period and is also continuing to
comply with all of the provisions of the UK
Combined Code.
The Board has overall responsibility for the
Company’s system of internal controls. Since
the publication in September 1999 by the
Institute of Chartered Accountants in England
and Wales of the Turnbull Report, ‘Internal
Control: Guidance for Directors on the UK
Combined Code’, the Directors have
continued to review the effectiveness of the
Group’s system of controls, risk management
and the Group’s high-level internal control
arrangements. These reviews have included
an assessment of internal controls, and in
particular internal, financial, operational and
compliance controls and risk management
and their effectiveness, supported by
The Nomination and Governance Committee
formally met three times in 2008. Each
member attended all of the formal meetings
except for Håkan Mogren due to a conflicting
appointment. The principal tasks in relation to
nomination matters in 2008 related to the
appointments of Jean-Philippe Courtois and
Rudy Markham to the Board. These
appointments further strengthened the Board
in terms of significant experience of sales
and product marketing in an organisation
with global reach, and in-depth financial
experience and expertise with international
companies. A leading external search
consultancy was used for the appointments
of both Non-Executive Directors to ensure
that the Company had access to candidates
with the appropriate set of skills and
competencies. In addition to considering
these new appointments to the Board, the
Nomination and Governance Committee also
reviewed the knowledge, experience and
balance of the Board overall and considered
its likely future requirements given the strategic
and business objectives of the Company.
The Nomination and Governance Committee’s
remit is available on the Company’s website,
astrazeneca.com.
SCIENCE CommITTEE
Science Committee members have a
knowledge of, or an interest in, life sciences.
During 2008, its members were Nancy
Rothwell (Science Committee Chairman),
Jane Henney, Jan Lundberg, John Patterson
and Bo Angelin. They are all Non-Executive
Directors, except Jan Lundberg and John
Patterson. The Global Head Discovery, Strategy
and Performance, also attends all meetings
and acts as secretary to this Committee.
The Science Committee’s principal tasks are:
To provide assurance to the Board >
regarding the quality, integrity and
competitiveness of the Company’s
science-based R&D activities. The
Committee aims to assure itself that
the approaches and targets adopted
throughout the R&D organisation are
competitive and an appropriate use
of shareholders’ funds, but is not
expected to review individual research
or licensing projects.
To consider reports from or join any >
meeting with any relevant external
advisory board when the Company
is considering entry into new areas
of science or medicine.
NomINATIoN ANd GovERNANCE CommITTEE
“During the year, the Nomination and
Governance Committee’s work focused
on identifying candidates of the calibre
and experience to further strengthen
the Board and its Committees, with the
help of specialist external search and
selection consultancies. This resulted
in the Nomination and Governance
Committee making recommendations
to the Board for the appointments of
both Jean-Philippe Courtois and Rudy
Markham as Non-Executive Directors.”
louIS SChWEITZER
Chairman of the Nomination and
Governance Committee
The Nomination and Governance Committee’s
core remit continues to be (after appropriate
consultation with the Chairman and the
Chief Executive Officer) to recommend to the
Board any new appointments of Directors.
Any decisions relating to the appointment
of a Director are made by the entire Board.
Following a change to its remit during 2008,
the Nomination and Governance Committee
also advises the Board periodically on
significant developments in corporate
governance and the Company’s compliance
with the UK Combined Code on Corporate
Governance. Consequently, the Committee
was re-named the Nomination and
Governance Committee.
The members of the Nomination and
Governance Committee during 2008
were Louis Schweitzer (Nomination and
Governance Committee Chairman), Håkan
Mogren, Jane Henney, Michele Hooper and
John Varley. They are all Non-Executive
Directors. With the exception of Håkan
Mogren (for the reasons explained on
page 92), the Board considers them all to be
independent (Louis Schweitzer was considered
independent upon his appointment as
Chairman to the Board; in accordance with
the UK Combined Code on Corporate
Governance, the test of independence is not
appropriate in relation to the Chairman after
his appointment). The Company Secretary
acts as secretary to this Committee.
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ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
conflict. In respect of the Executive Directors,
the Board (with the Executive Directors
abstaining) authorised any conflict that may
arise in relation to any of the Executive
Directors holding another directorship of
a company within the AstraZeneca Group.
In respect of the Non-Executive Directors,
no conflicts or potential conflicts were
considered to exist that required authorisation.
The Company Secretary will be responsible
for maintaining a register of notifications
received from Directors in relation to conflicts
of interest and, where appropriate, any
authorisation given. The Board will go through
a similar process on at least an annual basis.
uS CoRpoRATE GovERNANCE REQuIREmENTS
AstraZeneca PLC American Depositary
Shares are traded on the New York Stock
Exchange and, accordingly, the Company is
subject to the reporting and other requirements
of the US Securities and Exchange Commission
(SEC) applicable to foreign private issuers.
Section 404 of the US Sarbanes-Oxley Act
of 2002 requires companies to include in
their annual report on Form 20-F filed with
the SEC a report by management stating its
responsibility for establishing internal control
over financial reporting and to assess annually
the effectiveness of such internal control.
The Company has complied with those
provisions of the Act applicable to foreign
private issuers. The Board continues to
believe the Group has a sound corporate
governance framework, good processes for
the accurate and timely reporting of its
financial position and results of operations
and an effective and robust system of internal
controls. The Company has established a
Disclosure Committee, further details of which
can be found in the Disclosure Policy and
Disclosure Committee section on page 94.
Further information about the work undertaken
during 2008 to enable the Company to comply
with the SEC rules that implement section 404
of the Act can be found in the Sarbanes-Oxley
Act section 404 section of the Financial Review
on page 47. The Directors’ assessment of
the effectiveness of the internal control over
financial reporting is set out in the Financial
Statements on page 98.
The Company must disclose any significant
ways in which its corporate governance
practices differ from those followed by US
companies under the NYSE’s corporate
governance listing standards. In addition,
the Company must comply fully with the
provisions of the listing standards that relate
to the composition, responsibilities and
operation of audit committees. These
under the UK Combined Code. However,
the Board believes that they both have
brought, and continue to bring, considerable
business experience and to make valuable
contributions to the work of the Board.
Håkan Mogren was previously the Chief
Executive Officer of Astra AB and Executive
Deputy Chairman of the Company and is
now a member of the Board of Directors
of Investor AB, a company that, as at
31 December 2008, held approximately
3.6% of the Ordinary Shares of the Company.
This holding represents a significant proportion
of Investor AB’s overall investment portfolio.
Marcus Wallenberg was a member of the
Board of Directors and Chief Executive Officer
of Investor AB until 1 September 2005, when
he stepped down.
The Board also considered, in particular,
the position of Michele Hooper who joined
the board of UnitedHealth Group as a
Non-Executive Director in 2007. The Board’s
approval to this appointment was conditional
upon Michele Hooper resigning from the
board of UnitedHealth Group in the event
of a conflict or non-independence. It is the
Board’s view that Michele Hooper is
independent and that she discharges her
duties in a properly independent manner,
constructively and appropriately challenging
the Executive Directors and the Board.
Jane Henney is a Non-Executive Director of
AmerisourceBergen Corporation and CIGNA
Corporation, both of which are customers of
the Group in the US. The Board has considered
these relationships and concluded that they
did not compromise her independence.
The position of Senior Non-Executive Director
of the Company was established in 2002.
Michele Hooper (who was appointed as a
Non-Executive Director in 2003) became the
Companys Senior Non-Executive Director in
April 2007.
At the AGM in 2008, a resolution was passed
to amend the Articles to enable the Directors
to sanction conflicts of interest in relation to
any Director, that amounts, or could amount,
to a conflict with the Company’s interests and
which would otherwise be a breach of the
Director’s duty, under the relevant sections of
the UK Companies Act 2006.
In September 2008, letters were sent to each
of the Directors requesting them to notify the
Company of any such conflicts or potential
conflicts. The Board considered the responses
to these letters and in particular whether or
not they amounted to an actual or potential
management assurance of the maintenance
of control, reports from GIA, as well as the
external auditor on matters identified in the
course of its statutory audit work. The Board
is also responsible for reviewing the
effectiveness of the system of internal
controls and risk management policies.
The system is designed to manage rather
than eliminate the risk of failure to achieve
business objectives and can only provide
reasonable (not necessarily absolute)
assurance of effective operation and
compliance with laws and regulations.
Underpinning these reviews is an annual
‘letter of assurance’ process by which
responsible managers confirm the adequacy
of their systems of internal financial and
non-financial controls, their compliance
with Group policies, relevant laws and
regulations (including the industry’s
regulatory requirements), and confirm they
have reported any control weaknesses through
the Group’s ‘continuous assurance’ process.
The internal control framework has been in
operation for the whole of the year under review
and continues to operate up to the date of
the approval of this Report. The Directors
believe that the Group maintains an effective,
embedded system of internal controls and
complies with the Turnbull Report guidance
and, in the view of the Directors, no significant
failings have been identified in the system.
Further information on the ways in which we
manage our business risks is set out in the
section titled ‘Risk’ on page 74 and a list of
the principal risks and uncertainties is set
out in the Principal Risks and Uncertainties
section from page 76.
During 2008, the Board considered the
independence of each Non-Executive
Director. With the exception of two of them
(as set out below), the Board considers
that all of the Non-Executive Directors
are independent in character and judgement
and that there are no relationships or
circumstances that are likely to affect, or
could appear to affect, their independent
judgement. Louis Schweitzer was considered
by the Board to be independent upon his
appointment as Non-Executive Chairman;
in accordance with the UK Combined Code,
the test of independence is not appropriate in
relation to the Chairman after his appointment.
For the reasons explained below, the Board
believes that neither Håkan Mogren,
Non-Executive Deputy Chairman, nor Marcus
Wallenberg can be determined independent
Directors’ report
93
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
During 2008, the Global Compliance
Committee met regularly. The remit of the
committee is to oversee and co-ordinate
implementation of an effective global
compliance programme and evaluate its
effectiveness. It does this by assessing key
compliance risks within and across SET
areas; ensuring co-ordination of compliance
auditing and monitoring; reviewing results;
and addressing significant policy violations
and identifying trends.
Global Compliance provides direct assurance
to the Audit Committee on matters concerning
compliance issues, with a particular focus
on compliance with IFPMA, EFPIA and US
PhRMA codes. Complementing this, GIA
carries out a range of audits that includes
compliance-related audits and reviews of
the assurance activities of other Company
assurance functions. The results from these
activities are reported to the Audit Committee.
GIA is an independent appraisal function that
derives its authority from the Board through
the Audit Committee. Its primary role is to
provide reasonable and objective assurance
to the Directors about the adequacy and
effectiveness of the Company’s risk
management and control framework and
the internal controls over key business risks,
including financial controls and compliance
with laws, regulations and policies.
GIA seeks to discharge the responsibilities
set down in its charter by reviewing:
The processes for ensuring that key >
business risks are effectively managed.
The financial and operational controls >
that help to ensure that the Group’s
assets are properly safeguarded from
losses, including fraud.
The controls that help to ensure the >
reliability and integrity of management
information systems.
The processes for ensuring compliance >
with policies and procedures, external
legislation and regulation.
On an ad hoc basis, whether value for >
money is obtained (in terms of efficient
use of the Group’s resources).
GIA acts as a source of constructive advice and
best practice, assisting senior management
with its responsibility to improve governance,
control, compliance and risk management.
Code of Conduct. The number of reports
via the equivalent channels in 2007 was 133.
We believe the increase in the number of
reports via these channels is due, in part,
to our efforts to enhance these reporting
channels and, in part, to the increase in
awareness following the launch of the new
Code of Conduct and the accompanying
training and communications. To date, no
material issues have been identified through
these mechanisms.
The Group policies have also recently been
reviewed, and a new Global Policy Structure
was launched in November 2008 and came
into effect in January 2009. As with the Code
of Conduct, the Global Policies apply to all
members of the Group. Like the Code of
Conduct, the new Global Policies provide
clearer and more comprehensive guidance,
in plain language, to all managers and
employees as to their accountabilities in
key ethical, compliance and corporate
responsibility risk areas.
A critical element of the effective implementation
of the new Code of Conduct and Global
Policies is to deliver clear training and education
to employees on an ongoing basis. One of
the SET scorecard objectives for 2008 was
to train all our employees on the new Code
of Conduct during 2008. Training began in
July, and all employees have completed the
course. Further training will be delivered on
an annual basis.
A Group Finance Code of Conduct
complements the Code of Conduct.
It applies to the Chief Executive Officer,
the Chief Financial Officer, the Group’s
principal accounting officers (including key
Finance staff in major overseas subsidiaries)
and all Finance function employees, and it
reinforces the importance of the integrity of
the Group’s Financial Statements, of the
reliability of the accounting records on which
they are based and of the robustness of the
relevant controls and processes.
ComplIANCE ANd GRoup INTERNAl AudIT (GIA)
The role of the Global Compliance function
is to help embed a culture of ethics and
integrity at AstraZeneca. Global Compliance
works closely with GIA, with whom it provides
joint assurance reporting to the Audit
Committee. The key priorities for our Global
Compliance function for 2008/2009 are
closely aligned with the Company’s strategic
priorities. During 2009, the focus will be on
embedding the compliance framework
developed in 2008 into the business.
provisions incorporate the rules concerning
audit committees implemented by the SEC
under the Sarbanes-Oxley Act of 2002.
The Company has reviewed the corporate
governance practices required to be followed
by US companies under the NYSE’s listing
standards and its corporate governance
practices are generally consistent with those
standards. However, not all members of the
Nomination and Governance Committee are
considered independent for these purposes,
as explained in more detail on page 92.
CodE oF CoNduCT
The new AstraZeneca Code of Conduct was
launched in May 2008 and is available on the
Company’s website, astrazeneca.com. The
new Code became effective on 1 July 2008
and applies to all Directors, officers, full-time,
part-time, contractor and temporary staff at
all levels in every country where we operate.
It has been translated into over 40 languages
and every employee has a copy in his/her
local language. It is designed to provide
clear direction as to how the Company’s
commitment to honesty and integrity is to be
translated into consistent actions across all
areas of the business. Compliance with the
Code of Conduct and with the standards
detailed by the Company in support of it is
mandatory. The same applies to the laws and
regulations of the countries in which we work
and do business, as well as applicable
national and international codes, and the
Company seeks to operate to the highest of
these standards.
The new Code unites every member of the
Group under a single Code of Conduct.
It provides guidance across all areas of
activity previously covered by the US code,
which is therefore no longer required.
The Code also includes information on how to
report possible violations of the Code through
the appropriate channels, including the
AZethics telephone lines and the new global
website, AZethics.com. Anyone who raises a
possible breach in good faith will be supported
by management and will not be subject to
retaliation, which would itself be considered
a serious violation of the Code. We review all
alleged compliance breaches and concerns,
and we investigate and report on them to the
Audit Committee, as appropriate.
During 2008, 206 reports of alleged
compliance breaches or other ethical concerns
were made via the telephone helplines,
AZethics.com website or Global Compliance
e-mail or postal addresses described in the
94
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
changes in the global economy. In addition,
the Group has a wide diversity of customers
and suppliers across different geographic
areas. As a consequence, the Directors believe
that the Group is well placed to manage its
business risks successfully despite the
current uncertain economic outlook.
After making enquiries, the Directors have
a reasonable expectation that the Company
and the Group have adequate resources to
continue in operational existence for the
foreseeable future. Accordingly, they continue
to adopt the going concern basis in preparing
the Annual Report and Form 20-F Information
and Financial Statements.
Changes in share capital
Changes in the Company’s Ordinary Share
capital during 2008, including details of the
allotment of new shares under the Companys
share plans, are given in Note 20 to the
Financial Statements.
Directors’ shareholdings
The Company’s Articles require each Director
to be the beneficial owner of Ordinary Shares
in the Company with an aggregate nominal
value of $125 (500 shares). Such holding must
be obtained within two months of the date of
the Director’s appointment. At 31 December
2008, all of the Directors complied with this
requirement and full details of each Director’s
interests in shares of the Company are set
out in the Directors’ Remuneration Report on
page 185. Information about the shareholding
expectations of the Remuneration Committee
(in respect of Executive Directors and SET
members) and the Board (in respect of
Non-Executive Directors) is also set out in the
Directors’ Remuneration Report. Separately,
both the Non-Executive Directors and the
Executive Directors (and members of the SET)
are required as a matter of policy to build up a
minimum level of shareholding in the Company.
Details of these policies are set out in the
Directors’ Remuneration Report on pages
181 and 179, respectively.
Shareholder communications
In its financial and business reporting to
shareholders and other interested parties by
means of quarterly, half-year and full-year
reports, the Board aims to present a balanced
and understandable assessment of the
Group’s financial position and prospects.
The Company makes available to shareholders
information about the Company through a
range of media, including a fully integrated
html corporate website (astrazeneca.com)
containing a wide range of information of
interest to institutional and private investors.
AstraZeneca UK Limited: Albania, Algeria,
Bosnia and Herzegovina, Bulgaria, Chile,
Costa Rica, Croatia, Cuba, Ghana (scientific
office), Ireland, Jordan, Kazakhstan, Romania,
Russia, Serbia and Montenegro, Slovenia
and Ukraine.
AstraZeneca AB: Egypt (scientific office), Latvia,
Saudi Arabia (scientific office) and Slovakia.
AstraZeneca Export and Trading AB:
Estonia, Lithuania, Romania and the
United Arab Emirates.
Dividend
The Companys dividends for 2008 of $2.05
(132.6 pence, SEK 15.36) per Ordinary Share
amount to, in aggregate, a total dividend
payment to shareholders of $2,171 million.
Two of the Company’s employee share
trusts, AstraZeneca Share Trust Limited and
AstraZeneca Quest Limited, waive their right
to a dividend on the Ordinary Shares that they
hold and instead receive a nominal dividend.
Going concern accounting basis
Information on the business environment
AstraZeneca operates in, including the
factors underpinning the industry’s future
growth prospects, are included on pages
9 to 11 of this Directors’ Report. Details
of the product portfolio of the Group, our
approach to product development and our
development pipeline are included on pages
16 to 24, with additional information by major
product group on pages 53 to 70.
The financial position of the Group, its cash
flows, liquidity position and borrowing facilities
are described in the Financial Review.
In addition, Notes 15 and 16 to the Financial
Statements include the Group’s objectives,
policies and processes for managing its
capital, its financial risk management objectives,
details of its financial instruments and hedging
activities and its exposures to credit, market
and liquidity risk. Further details of the Groups
cash balances and borrowings are included in
Notes 13 and 14 of the Financial Statements.
The Group has considerable financial
resources available. As at 31 December
2008, the Group has $7.8 billion in financial
resources (cash balances of $4.3 billion
and committed bank facilities of $4.3 billion,
with $0.8 billion of debt due within one year).
The Group’s revenues are largely derived
from sales of products which are covered
by patents and for which, in the short term
at least, demand is relatively unaffected by
dISCloSuRE polICY ANd dISCloSuRE CommITTEE
The Group’s Disclosure Policy provides a
framework for the handling and disclosure
of inside information and other information of
interest to shareholders and the investment
community. It also defines the role of the
Disclosure Committee. The Chief Financial
Officer, the Executive Director, Development,
the Group Secretary and Solicitor, the
Vice-President, Corporate Affairs, the
Vice-President, Investor Relations and the
Senior Vice-President, Group Finance were
the members of the Disclosure Committee
during 2008. The Deputy Company
Secretary acts as secretary to this
committee. The Disclosure Committee meets
regularly to assist and inform the decisions of
the Chief Executive Officer concerning inside
information and its disclosure. Periodically,
it reviews the Group’s disclosure controls and
procedures and its own operation as part
of work carried out to enable management
and the Board to assure themselves that
appropriate processes are operating for
the Companys planned disclosures, such
as its quarterly results announcements and
scheduled investor relations events. In addition,
the Disclosure Committee members are
members of the steering group that reviews
the drafts of, and the process for preparing,
this Annual Report and Form 20-F Information.
dISCloSuRE oF INFoRmATIoN To AudIToRS
The Directors who held office at the date of
approval of this Directors’ Report confirm
that, so far as they are each aware, there is
no relevant audit information of which the
Company’s auditors are unaware; and each
Director has taken all the steps that he/she
ought to have taken as a Director to make
himself/herself aware of any relevant audit
information and to establish that the
Company’s auditors are aware of that
information.
oThER mATTERS
oThER CompANY dISCloSuRES ANd INFoRmATIoN
Subsidiaries and principal activities
AstraZeneca PLC is the holding company
for a group of subsidiaries whose principal
activities are described in this Directors’ Report
on pages 8 to 96. Principal subsidiaries
and their locations are given in the Principal
Subsidiaries section on page 164.
Branches and countries in which
the Company conducts business
In accordance with the Companies Act 1985,
we disclose below the members of the
Group that have representative or scientific
branches/offices outside the UK:
Directors’ report
95
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
However, to enable the Company to continue
to support interest groups or lobbying
organisations concerned with the review of
government policy or law reform without
inadvertently breaching the Companies Act
2006, which defines political donations and
other political expenditure in broad terms, a
resolution will be put to shareholders at the
2009 AGM, similar to that passed at the AGM
on 24 April 2008, to authorise the Company
and its subsidiaries to make: (i) donations
to political parties; (ii) donations to political
organisations other than political parties;
and (iii) incur political expenditure, up to an
aggregate limit of $250,000.
In 2008, AstraZeneca’s US legal entities
made contributions amounting in aggregate
to $815,838 (2007: $321,645) to state
political party committees and to campaign
committees of various state candidates
affiliated with the major parties in accordance
with pre-established guidelines. No corporate
donations were made at federal level, and all
contributions were made only where allowed
by US federal and state law. American
citizens or individuals holding valid green
cards exercised decision-making over the
contributions and the funds were not
provided or reimbursed by any non-US legal
entity. Such contributions do not constitute
political donations or political expenditure
for the purposes of the Companies Act 1985
or Companies Act 2006 and were made
without any involvement of persons or entities
outside the US.
Takeovers directive
Following the implementation of paragraph
13, Part VII, Schedule 7 of the Companies
Act 1985 (inserted by section 992 of the
Companies Act 2006), the Company is
required to make certain additional disclosures.
Where disclosures are required they can be
found in other parts of this Report as listed
below, each of which is incorporated into
this Directors’ Report:
Structure of the Company’s share capital >
and rights and obligations attaching to
shares (contained in the Corporate
Information section starting on page 197
and Notes to the Financial Statements on
page 129).
Significant holders of the Company’s >
shares (contained in the Shareholder
Information section starting on page 190).
Appointment and replacement of >
Directors (contained in the Corporate
Governance section starting on page 83).
Distributions to shareholders
The Company’s stated distribution policy
comprises both a regular cash dividend and
a share re-purchase component, further
details of which are set out in the Financial
Review on page 37 and the Financial
Statements on page 129.
Pursuant to the shareholders’ resolution
passed at the 2008 AGM authorising the
Company to purchase its own shares,
during 2008 the Company re-purchased
(and subsequently cancelled) 13.6 million of
its own Ordinary Shares with a nominal value
of $0.25 each, at an aggregate cost of
$610 million, representing 0.9% of the total
issued share capital of the Company.
The average price paid per share in 2008
was 2397 pence. Shares issued in respect
of share schemes totalled 4.1 million.
The Board announced in the Third Quarter
and Nine Month Results 2008 that no further
share re-purchases would take place in 2008
in order to maintain the flexibility to invest in
the business. For the same reason, the
Board has decided that no share re-
purchases will take place in 2009.
The Company executed the share re-purchase
programme through a combination of
discretionary purchases and through
irrevocable, non-discretionary instructions.
The Company continues to maintain robust
controls in respect of all aspects of the share
re-purchase programme to ensure compliance
with English and other applicable law and
the Financial Services Authoritys Listing
Rules, Disclosure and Transparency Rules
and Prospectus Rules. However, in order
to maintain flexibility, the Company will seek
a renewal of its current permission from
shareholders to purchase its own shares at
the AGM on 30 April 2009.
Since the Company began its share
re-purchase programmes in 1999, a total
of 376.3 million Ordinary Shares were
re-purchased, and subsequently cancelled,
at an average price of 2661 pence per share
for a consideration, including expenses, of
$18,099 million.
Political donations
Neither the Company nor its subsidiaries made
any donations or incurred any expenditure in
2008 in the EU and they do not intend to do
so in the future in respect of which shareholder
authority is required (or for which disclosure in
this Report is required under the Companies
Act 2006).
The Company considers its website to be an
important means of communication with
shareholders. Accordingly, and as permitted
by a change in UK company law, at the 2007
AGM of the Company, a resolution was
proposed and approved which authorised
the Company to place shareholder
communications (such as the Notice of
AGM and the Annual Report and Form 20-F
Information) on its corporate website in lieu of
sending paper copies to shareholders (unless
specifically requested by shareholders).
Whilst recognising and respecting the fact
that some of our stakeholders may have
different preferences regarding the manner in
which they receive information about the
Company, we will continue to promote the
benefits of electronic communication given
the advantages that this has over traditional
paper-based communications both in terms
of the configurability and accessibility of the
information that is provided and the
consequent cost savings and reduction in
environmental impact associated with
reduced printing and distribution costs.
The Company has frequent discussions with
institutional shareholders on a range of issues
affecting its performance. These include
individual meetings with some of the
Companys largest institutional shareholders
to seek their views and any concerns can
be reported to the Board. In addition, the
Company responds to individual ad hoc
requests for discussions from institutional
shareholders and analysts. The Group’s
Investor Relations department acts as a main
point of contact for investors throughout the
year. The Senior Non-Executive Director is
also available to shareholders if they have
concerns that contact through the normal
channels of Chairman, Chief Executive
Officer, Chief Financial Officer and/or the
Group Investor Relations department has
failed to resolve, or in relation to which such
contact is inappropriate.
All shareholders, including private investors,
have an opportunity at the AGM to put
questions to members of the Board on
matters relating to the Company’s operation
and performance. Formal notification of the
AGM is sent to shareholders at least one
month in advance. The Chairmen of the
Board’s committees ordinarily attend the
AGM to answer questions raised by
shareholders. In line with the UK Combined
Code, details of proxy voting by shareholders,
including votes withheld, are made available
on request and are placed on the Company’s
website following the AGM.
96
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
External auditor
A resolution will be proposed at the AGM
on 30 April 2009 for the re-appointment
of KPMG Audit Plc, London as auditor of
the Company.
The external auditor has undertaken various
pieces of non-audit work for the Company
during 2008. More information about this
work and the audit and non-audit fees
paid by the Company are set out in Note 27
to the Financial Statements on page 163.
The external auditor is not engaged by the
Company to carry out any non-audit work
on which it might, in the future, be required to
express an audit opinion. As explained more
fully in the Audit Committee section on page
89, the Audit Committee has established
pre-approval policies and procedures for audit
and non-audit work permitted to be carried
out by the external auditor and has carefully
monitored the objectivity and independence
of the external auditor throughout 2008.
Bureau Veritas
Bureau Veritas UK Limited has provided
external assurance on corporate responsibility
related information within this Annual Report
and Form 20-F Information, and of the
detailed content of theResponsibilitysection
of AstraZenecas corporate website. Bureau
Veritas has found the information provided
within this Report to be accurate and reliable.
The full assurance statement containing
detailed scope, methodology, overall opinion
and recommendations can be found on
AstraZeneca’s website, astrazeneca.com;
web page content assured by Bureau Veritas
is marked at the bottom of each page.
Bureau Veritas is an independent professional
services company that specialises in Quality,
Health, Safety, Social and Environmental
Management with a long history in providing
independent assurance services, and an
annual turnover in 2007 of €2.06 billion.
On behalf of the Board
A C N KEmp
Company Secretary
29 January 2009
Powers of Directors (contained in the >
Corporate Governance section starting
on page 83).
Amendments to the Company’s Articles >
(contained in the Corporate Information
section starting on page 197).
Details of the Company’s employee share >
schemes (set out on pages 139 to 142).
There are no significant agreements to which
the Company is a party that take effect, alter
or terminate on a change of control of the
Company following a takeover bid.
There are no persons, with whom the
Company has contractual or other
arrangements, who are deemed to be
essential to the business of the Company.
Use of financial instruments
Notes 15 and 16 to the Financial Statements
entitled Financial Risk Management Objectives
and Policies/Financial Instruments on pages
120 to 126, include further information on the
Company’s use of financial instruments.
Creditor payment policy
It is not Company policy formally to comply
with the Confederation of British Industry’s
code of practice on the prompt payment of
suppliers. It is, however, Company policy to
agree to appropriate payment terms with all
suppliers when agreeing to the terms of each
transaction, to ensure that those suppliers
are made aware of the terms of payment and,
subject to their compliance, abide by the terms
of payment. The total amount of money owed
by AstraZeneca PLC’s subsidiaries to trade
creditors at the balance sheet date was
equivalent to 92 days’ average purchases
(2007: 81 days). No equivalent disclosure is
provided in respect of AstraZeneca PLC, as it
has no external trade creditors.
Annual General Meeting
The Companys AGM will be held on 30 April
2009. The meeting place will be in London.
A Notice of AGM will be sent to all registered
holders of Ordinary Shares and, where
requested, to the beneficial holders of shares.
FINANCIAL STATEMENTS
98
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
PrEPArATIoN oF ThE FINANCIAL STATEMENTS ANd dIrECTorS
rESPoNSIbILITIES
dIrECTorS’ rESPoNSIbILITIES For, ANd rEPorT oN, INTErNAL CoNTroL
ovEr FINANCIAL rEPorTINg
The Directors are responsible for preparing
the Annual Report and Form 20-F Information
and the Group and Company Financial
Statements, in accordance with applicable
law and regulations.
Company law requires the Directors to prepare
Group and Company Financial Statements
for each financial year. Under that law they
are required to prepare the Group Financial
Statements in accordance with IFRSs as
adopted by the European Union (EU) and
applicable law and have elected to prepare
the Company Financial Statements in
accordance with UK Accounting Standards
and applicable law (UK Generally Accepted
Accounting Practice).
The Group Financial Statements are required
by law and IFRSs as adopted by the EU to
present fairly the financial position and
performance of the Group; the Companies
Act 1985 provides in relation to such financial
statements that references in the relevant
part of that Act to financial statements giving
a true and fair view are references to their
achieving a fair presentation.
The Company has also elected to prepare the
Group Financial Statements in accordance
with IFRS as issued by the International
Accounting Standards Board.
The Company Financial Statements are
required by law to give a true and fair view
of the state of affairs of the Company.
The Directors are responsible for establishing
and maintaining adequate internal control
over financial reporting. AstraZeneca’s
internal control over financial reporting is
designed to provide reasonable assurance
over the reliability of financial reporting and
the preparation of consolidated financial
statements in accordance with generally
accepted accounting principles.
Due to its inherent limitations, internal control
over financial reporting may not prevent or
detect misstatements. Projections of any
evaluation of effectiveness to future periods
are subject to the risks that controls may
In preparing each of the Group and Company
Financial Statements, the Directors are
required to:
Select suitable accounting policies and >
then apply them consistently.
Make judgements and estimates that >
are reasonable and prudent.
For the Group Financial Statements, >
state whether they have been prepared
in accordance with IFRSs as adopted
by the EU.
For the Company Financial Statements, >
state whether applicable UK Accounting
Standards have been followed, subject
to any material departures disclosed
and explained in the Company
Financial Statements.
Prepare the Financial Statements on >
the going concern basis unless it is
inappropriate to presume that the
Group and the Company will continue
in business.
The Directors are responsible for keeping
proper accounting records that disclose with
reasonable accuracy at any time the financial
position of the Company and enable them to
ensure that its financial statements comply with
the Companies Act 1985. They have general
responsibility for taking such steps as are
reasonably open to them to safeguard the
assets of the Group and the Company and to
prevent and detect fraud and other irregularities.
become inadequate because of changes
in conditions or that the degree of
compliance with the policies or procedures
may deteriorate.
The Directors assessed the effectiveness of
AstraZenecas internal control over financial
reporting as at 31 December 2008 based
on the criteria set forth by the Committee of
Sponsoring Organizations of the Treadway
Commission in Internal Control-Integrated
Framework. Based on this assessment, the
Directors believe that, as at 31 December
2008, the internal control over financial
reporting is effective based on those criteria.
Under applicable law and regulations, the
Directors are also responsible for preparing
a Directors’ Report, Directors’ Remuneration
Report and Corporate Governance Statement
that comply with that law and those regulations.
The Directors are responsible for the
maintenance and integrity of the corporate
and financial information included on the
Company’s website. Legislation in the UK
governing the preparation and dissemination
of Financial Statements may differ from
legislation in other jurisdictions.
dIRECToRS’ RESpoNSIbIlITy STATEmENT
puRSuANT To dTR 4
The Directors confirm that to the best of
our knowledge:
The Financial Statements, prepared in >
accordance with the applicable set of
accounting standards, give a true and
fair view of the assets, liabilities, financial
position and profit or loss of the Company
and the undertakings included in the
consolidation taken as a whole.
The Directors’ Report includes a fair review >
of the development and performance of
the business and the position of the issuer
and the undertakings included in the
consolidation taken as a whole, together
with a description of the principal risks
and uncertainties that they face.
On behalf of the Board of Directors on
29 January 2009:
dAvId R bRENNAN
Director
KPMG Audit Plc, an independent registered
public accounting firm, has audited the
effectiveness of internal control over financial
reporting as at 31 December 2008 and,
as explained on page 99, has issued an
unqualified report thereon.
99
FINANCIAL STATEMENTS
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
AudITor’S rEPorTS oN ThE FINANCIAL STATEMENTS ANd oN INTErNAL
CoNTroL ovEr FINANCIAL rEPorTINg (SArbANES-oxLEy ACT SECTIoN 404)
INdEPENdENT AudITor’S rEPorT To ThE MEMbErS oF ASTrAZENECA PLC
The report set out below is provided in
compliance with International Standards on
Auditing (UK and Ireland). KPMG Audit Plc
has also issued reports in accordance with
auditing standards of the Public Company
Accounting Oversight Board in the US, which
will be included in the Annual Report on Form
20-F to be filed with the US Securities and
We have audited the Group Financial
Statements of AstraZeneca PLC for the
year ended 31 December 2008 which
comprise the Consolidated Income
Statement, the Consolidated Balance Sheet,
the Consolidated Cash Flow Statement,
the Consolidated Statement of Recognised
Income and Expense and the related notes
on pages 100 to 164. These Group Financial
Statements have been prepared under the
accounting policies set out therein.
We have reported separately on the Company
Financial Statements of AstraZeneca PLC
for the year ended 31 December 2008
and on the information in the Directors’
Remuneration Report that is described as
having been audited.
This report is made solely to the Companys
members, as a body, in accordance with
section 235 of the Companies Act 1985 and,
in respect of the separate opinion in relation
to International Financial Reporting Standards
(IFRSs) as issued by the International
Accounting Standards Board (IASB), on terms
that have been agreed with the Company.
Our audit work has been undertaken so that
we might state to the Company’s members
those matters we are required to state to
them in an auditor’s report and, in respect
of the separate opinion in relation to IFRSs
as issued by the IASB, those matters that we
have agreed to state to them in our report,
and for no other purpose. To the fullest extent
permitted by law, we do not accept or
assume responsibility to anyone other than
the Company and the Company’s members
as a body, for our audit work, for this report,
or for the opinions we have formed.
RESpECTIvE RESpoNSIbIlITIES oF
dIRECToRS ANd AudIToRS
The Directors’ responsibilities for preparing the
Annual Report and Form 20-F Information and
the Group Financial Statements in accordance
with applicable law and IFRSs as adopted
by the European Union (EU) are set out in
the Statement of Directors’ Responsibilities
on page 98.
Our responsibility is to audit the Group
Financial Statements in accordance with
Exchange Commission. Those reports are
unqualified and include opinions on the
Financial Statements and on the effectiveness
of internal control over financial reporting as
at 31 December 2008 (Sarbanes-Oxley Act
Section 404). The Directors’ statement on
internal control over financial reporting is set
out on page 98.
relevant legal and regulatory requirements
and International Standards on Auditing
(UK and Ireland).
We report to you our opinion as to whether
the Group Financial Statements give a true
and fair view and whether the Group Financial
Statements have been properly prepared in
accordance with the Companies Act 1985 and
Article 4 of the IAS Regulation. We also report
to you whether in our opinion the information
given in the Directors’ Report is consistent
with the Group Financial Statements.
In addition we report to you if, in our opinion,
we have not received all the information
and explanations we require for our audit,
or if information specified by law regarding
Directors’ remuneration and other transactions
is not disclosed.
We review whether the Corporate Governance
Statement reflects the Company’s compliance
with the nine provisions of the 2006 Combined
Code specified for our review by the Listing
Rules of the Financial Services Authority, and
we report if it does not. We are not required to
consider whether the Board’s statements on
internal control cover all risks and controls, or
form an opinion on the effectiveness of the
Groups corporate governance procedures
or its risk and control procedures.
We read the other information contained in
the Annual Report and Form 20-F Information
and consider whether it is consistent with
the audited Group Financial Statements.
We consider the implications for our report if we
become aware of any apparent mis-statements
or material inconsistencies with the Group
Financial Statements. Our responsibilities do
not extend to any other information.
bASIS oF AudIT opINIoN
We conducted our audit in accordance with
International Standards on Auditing (UK and
Ireland) issued by the Auditing Practices
Board. An audit includes examination, on a
test basis, of evidence relevant to the amounts
and disclosures in the Group Financial
Statements. It also includes an assessment
of the significant estimates and judgments
made by the Directors in the preparation of the
KPMG Audit Plc has also reported separately
on the Company Financial Statements of
AstraZeneca PLC and on the information
in the Directors’ Remuneration Report that
is described as having been audited. This
audit report is set out on page 165.
Group Financial Statements, and of whether
the accounting policies are appropriate to the
Group’s circumstances, consistently applied
and adequately disclosed.
We planned and performed our audit so as
to obtain all the information and explanations
which we considered necessary in order
to provide us with sufficient evidence to
give reasonable assurance that the Group
Financial Statements are free from material
misstatement, whether caused by fraud or
other irregularity or error. In forming our
opinion we also evaluated the overall
adequacy of the presentation of information
in the Group Financial Statements.
opINIoN
In our opinion:
The Group Financial Statements give a true >
and fair view, in accordance with IFRSs as
adopted by the EU, of the state of the
Groups affairs as at 31 December 2008
and of its profit for the year then ended.
The Group Financial Statements have been >
properly prepared in accordance with the
Companies Act 1985 and Article 4 of the
IAS Regulation.
The information given in the Directors’ >
Report is consistent with the Group
Financial Statements.
SEpARATE opINIoN IN RElATIoN To IFRSs
As explained in the accounting policies set
out in the Group Financial Statements, in
addition to complying with its legal obligation
to comply with IFRSs as adopted by the EU,
the Group has also complied with IFRSs as
issued by the IASB.
In our opinion the Group Financial Statements
give a true and fair view, in accordance with
IFRSs as issued by the IASB, of the state of
the Group’s affairs as at 31 December 2008
and of its profit for the year then ended.
KPMG Audit Plc
Chartered Accountants
Registered Auditor
8 Salisbury Square
London EC4Y 8BB
29 January 2009
100
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
CoNSoLIdATEd INCoME STATEMENT For ThE yEAr ENdEd 31 dECEMbEr
2008 2007 2006
Notes $m $m $m
Revenue 31,601 29,559 26,475
Cost of sales (6,598) (6,419) (5,559)
Gross profit 25,003 23,140 20,916
Distribution costs (291) (248) (226)
Research and development (5,179) (5,162) (3,902)
Selling, general and administrative costs (10,913) (10,364) (9,096)
Other operating income and expense 1 524 728 524
Operating profit 1 9,144 8,094 8,216
Finance income 2 854 959 888
Finance expense 2 (1,317) (1,070) (561)
Profit before tax 8,681 7,9 83 8 ,5 4 3
Taxation 3 (2,551) (2,356) (2,480)
Profit for the period 6,130 5,627 6,063
Attributable to:
Equity holders of the Company 6,101 5,595 6,043
Minority interests 29 32 20
Basic earnings per $0.25 Ordinary Share 4 $4.20 $3.74 $3.86
Diluted earnings per $0.25 Ordinary Share 4 $4.20 $3.73 $3.85
Weighted average number of Ordinary Shares in issue (millions) 4 1,453 1,495 1,564
Diluted weighted average number of Ordinary Shares in issue (millions) 4 1,453 1,498 1,570
Dividends declared and paid in the period 21 2,767 2,658 2,217
All activities were in respect of continuing operations.
2008 2007 2006
Notes $m $m $m
Profit for the period 6,130 5,627 6,063
Foreign exchange arising on consolidation (1,336) 492 922
Foreign exchange differences on borrowings forming net investment hedges 291 (40)
Gain/(loss) on cash flow hedge in connection with debt issue 1 (21)
Available for sale gains/(losses) taken to equity 2 (9) (20)
Actuarial loss for the period (1,232) (113) (108)
Tax on items taken directly to reserves 3 368 33 137
Income and expense recognised directly in equity (1,906) 342 931
Total recognised income and expense for the period 19 4,224 5,969 6,994
Attributable to:
Equity holders of the Company 19 4,176 5,934 6,970
Minority interests 19 48 35 24
$m means millions of US dollars.
CoNSoLIdATEd STATEMENT oF rECogNISEd INCoME ANd ExPENSE
For ThE yEAr ENdEd 31 dECEMbEr
101
FINANCIAL STATEMENTS
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
CoNSoLIdATEd bALANCE ShEET AT 31 dECEMbEr
2008 2007 2006
Notes $m $m $m
Assets
Non-current assets
Property, plant and equipment 7 7,043 8,298 7,453
Goodwill 8 9,874 9,884 1,097
Intangible assets 9 12,323 11,467 3,107
Other investments 10 156 182 119
Deferred tax assets 3 1,236 1,044 1,220
30,632 30,875 12,996
Current assets
Inventories 11 1,636 2,119 2,250
Trade and other receivables 12 7,261 6,668 5,561
Other investments 10 388 177 657
Income tax receivable 2,581 2,251 1,365
Cash and cash equivalents 13 4,286 5,8 67 7,10 3
16,152 17,0 8 2 16 ,9 36
Total assets 46,784 47,957 29,932
Liabilities
Current liabilities
Interest bearing loans and borrowings 14 (993) (4,280) (136)
Trade and other payables 17 (7,178) (6,968) (6,295)
Provisions 18 (600) (387) (39)
Income tax payable (4,549) (3,552) (2,977)
(13,320) (15,187) (9,447)
Non-current liabilities
Interest bearing loans and borrowings 14 (10,855) (10,876) (1,087)
Deferred tax liabilities 3 (3,126) (4,119) (1,5 59)
Retirement benefit obligations 23 (2,732) (1,998) (1,842)
Provisions 18 (542) (633) (327)
Other payables 17 (149) (229) (254)
(17,4 04) (17,855) (5,069)
Total liabilities (30,724) (33,042) (14,516)
Net assets 16,060 14,915 15,416
Equity
Capital and reserves attributable to equity holders of the Company
Share capital 20 362 364 383
Share premium account 19 2,046 1,888 1,671
Capital redemption reserve 19 94 91 71
Merger reserve 19 433 433 433
Other reserves 19 1,405 1,378 1,398
Retained earnings 19 11,572 10,624 11,3 48
15,912 14,778 15,304
Minority equity interests 19 148 137 112
Total equity 19 16,060 14,915 15,416
The Financial Statements on pages 100 to 164 were approved by the Board of Directors on 29 January 2009 and were signed on its behalf by:
dAvId R bRENNAN SImoN loWTH
Director Director
102
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
CoNSoLIdATEd CASh FLow STATEMENT
For ThE yEAr ENdEd 31 dECEMbEr
2008 2007 2006
Notes $m $m $m
Cash flows from operating activities
Profit before tax 8,681 7, 98 3 8, 54 3
Finance income and expense 2 463 111 (327 )
Depreciation, amortisation and impairment 2,620 1,856 1,345
Increase in trade and other receivables (1,032) (717) (470)
Decrease in inventories 185 442 158
Increase/(decrease) in trade and other payables 637 (168) 420
Other non-cash movements 87 901 263
Cash generated from operations 11,641 10,408 9,932
Interest paid (690) (335) (70)
Tax paid (2,209) (2,563) (2,169)
Net cash inflow from operating activities 8,742 7, 510 7, 69 3
Cash flows from investing activities
Acquisitions of business operations 22 (14,891) (1,148)
Movement in short term investments and fixed deposits 1 89 4 1,120
Purchase of property, plant and equipment (1,095) (1,130) ( 794)
Disposal of property, plant and equipment 38 54 35
Purchase of intangible assets (2,944) (549) (545)
Disposal of intangible assets 661
Purchase of non-current asset investments (40) (35) (17)
Disposal of non-current asset investments 32 421 68
Interest received 149 358 352
Payments made by subsidiaries to minority interests (37) (9) (4)
Net cash outflow from investing activities (3,896) (14,887) (272)
Net cash inflow/(outflow) before financing activities 4,846 ( 7,37 7) 7,42 1
Cash flows from financing activities
Proceeds from issue of share capital 159 218 985
Re-purchase of shares (610) (4,170) (4,147)
Issue of loans 787 9,692
Repayment of loans (1,16 5)
Dividends paid (2,739) (2,641) (2,220)
Movement in short term borrowings (3,959) 4,117 16
Net cash (outflow)/inflow from financing activities (6,362) 6,051 (5,366)
Net (decrease)/increase in cash and cash equivalents in the period (1,516) (1,326) 2,055
Cash and cash equivalents at beginning of the period 5,727 6,989 4,895
Exchange rate effects (88) 64 39
Cash and cash equivalents at the end of the period 13 4,123 5,727 6,989
103
FINANCIAL STATEMENTS
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
ACCouNTINg PoLICIES
bASIS oF ACCouNTINg ANd pREpARATIoN
oF FINANCIAl INFoRmATIoN
The Consolidated Financial Statements have
been prepared under the historical cost
convention, modified to include revaluation
to fair value of certain financial instruments
as described below, in accordance with
the Companies Act 1985 and International
Financial Reporting Standards (IFRSs) as
adopted by the European Union (“adopted
IFRS”) in response to the IAS regulation
(EC 1606/2002). The Consolidated Financial
Statements also comply fully with IFRSs
as issued by the International Accounting
Standards Board. IFRIC 14IAS 19 – The Limit
on a Defined Benefit Asset, Minimum Funding
Requirements and their Interaction’ has
been adopted in the year which is considered
early adoption under EU adopted IFRS.
‘Reclassification of Financial Assets’
amendments to IAS 39 ‘Financial
Instruments: Recognition and Measurement’
and IFRS 7 ‘Financial Instruments:
Disclosures’ has been issued and we have
applied the principles of IFRIC 12 ‘Service
Concession Arrangements’. Adoption of
these new requirements has had no effect
on the Consolidated Financial Statements.
The amendment to IAS 39 ‘Financial
Instruments: Recognition and Measurement
and IFRS 7 Financial Instruments: Disclosures
Reclassification of Financial Assets’ has been
adopted but had no impact on the overall
reported results.
The Company has elected to prepare the
Company Financial Statements in accordance
with UK Accounting Standards. These are
presented on pages 166 to 171 and the
accounting policies in respect of Company
information are set out on page 167.
The Consolidated Financial Statements are
presented in US dollars, which is the
Company’s functional currency.
In preparing their individual financial
statements, the accounting policies of some
overseas subsidiaries do not conform with
adopted IFRSs. Therefore, where appropriate,
adjustments are made in order to present
the Group Financial Statements on a
consistent basis.
bASIS FoR pREpARATIoN oF FINANCIAl
STATEmENTS oN A goINg CoNCERN bASIS
Information on the business environment
AstraZeneca operates in, including the
factors underpinning the industry’s future
growth prospects, are included in the
Directors’ Report. Details of the product
portfolio of the Group, our approach to
product development and our development
pipeline are covered in detail with additional
information by major product group in the
Directors’ Report.
The financial position of the Group, its cash
flows, liquidity position and borrowing facilities
are described in the Financial Review.
In addition, Notes 15 and 16 to the Financial
Statements includes the Group’s objectives,
policies and processes for managing its capital,
its financial risk management objectives,
details of its financial instruments and hedging
activities and its exposures to credit, market
and liquidity risk. Further details of the Groups
cash balances and borrowings are included in
Notes 13 and 14 of the Financial Statements.
The Group has considerable financial
resources available. As at 31 December
2008, the Group has $7.8 billion in financial
resources (cash balances of $4.3 billion
and committed bank facilities of $4.3 billion,
with $0.8 billion of debt due within one year).
The Group’s revenues are largely derived
from sales of products which are covered by
patents and for which, historically at least,
demand has been relatively unaffected by
changes in the general economy. In addition,
the Group has a wide diversity of customers
and suppliers across different geographic
areas. As a consequence, the Directors believe
that the Group is well placed to manage its
business risks successfully despite the
current uncertain economic outlook.
After making enquiries, the Directors have
a reasonable expectation that the Company
and the Group have adequate resources
to continue in operational existence for the
foreseeable future. Accordingly, they continue
to adopt the going concern basis in preparing
the Annual Report and Financial Statements.
ESTImATES ANd judgEmENTS
The preparation of the Financial Statements
in conformity with generally accepted
accounting principles requires management
to make estimates and judgements that affect
the reported amounts of assets and liabilities
at the date of the Financial Statements and
the reported amounts of revenues and
expenses during the reporting period. Actual
results could differ from those estimates.
Judgements include classification of
transactions between the income statement
and balance sheet, whilst estimates focus
on areas such as carrying values and
estimated lives.
AstraZenecas management considers
the following to be the most important
accounting policies in the context of the
Group’s operations.
The accounting policy descriptions set
out the areas where judgement needs
exercising, the most significant of which
are revenue recognition, research and
development, goodwill and intangible
assets, litigation and environmental liabilities,
post-retirement benefits, taxation and
share-based compensation.
Further information on critical judgements
made in applying accounting policies,
including details of significant methods and
assumptions used, is included in Notes 8, 9,
16, 22, 23, 24 and 25. The financial risk
management policies are detailed in Note 15.
REvENuE
Revenues exclude inter-company sales and
value-added taxes and represent net invoice
value less estimated rebates, returns and
settlement discounts. Revenues are recognised
when the significant risks and rewards of
ownership have been transferred to a third
party. In general this is upon delivery of the
products to wholesalers. However, when a
product faces generic competition particular
attention is given to the possible levels of
returns and, in cases where the circumstances
are such that the level of returns (and, hence,
revenue) cannot be measured reliably,
revenues are only recognised when the right
of return expires which is generally on ultimate
prescription of the product to patients.
RESEARCH ANd dEvElopmENT
Research expenditure is recognised in the
income statement in the year in which it
is incurred.
Internal development expenditure is capitalised
only if it meets the recognition criteria of
IAS 38 ‘Intangible Assets’. Where regulatory
and other uncertainties are such that the
criteria are not met the expenditure
is recognised in the income statement. This is
almost invariably the case prior to approval of
the drug by the relevant regulatory authority.
Where, however, the recognition criteria are
met, intangible assets are capitalised and
amortised on a straight-line basis over their
useful economic lives from product launch.
As at 31 December 2008, no amounts have
met the recognition criteria. Payments to
in-licence products and compounds from
external third parties, generally taking the
form of up-front payments and milestones,
are capitalised and amortised, generally on a
straight-line basis, over their useful economic
lives from product launch. Under this policy, it
is not possible to determine precise economic
lives for individual classes of intangible assets.
However, lives range from three years to
twenty years.
104
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
model. In accordance with IFRS 2 ‘Share-
based Payment’, the resulting cost is
recognised in the income statement over
the vesting period of the options, being the
period in which the services are received.
The value of the charge is adjusted to reflect
expected and actual levels of awards vesting,
except where the failure to vest is as a result
of not meeting a market condition.
pRopERTy, plANT ANd EquIpmENT
The Group’s policy is to write off the difference
between the cost of each item of property,
plant and equipment and its residual value
systematically over its estimated useful life.
Assets under construction are not depreciated.
Reviews are made annually of the estimated
remaining lives and residual values of
individual productive assets, taking account of
commercial and technological obsolescence
as well as normal wear and tear. Under this
policy it becomes impractical to calculate
average asset lives exactly. However, the
total lives range from approximately thirteen
tofty years for buildings, and three to fifteen
years for plant and equipment. All items of
property, plant and equipment are tested for
impairment when there are indications that
the carrying value may not be recoverable.
Any impairment losses are recognised
immediately in the income statement.
boRRoWINg CoSTS
Borrowing costs are recognised in the income
statement as incurred and in accordance
with the effective interest rate method.
lEASES
Rentals under operating leases are charged to
the income statement on a straight-line basis.
SubSIdIARIES
A subsidiary is an entity controlled, directly or
indirectly, by AstraZeneca. Control is regarded
as the power to govern the financial and
operating policies of the entity so as to obtain
benefits from its activities.
The financial results of subsidiaries are
consolidated from the date control is
obtained until the date that control ceases.
INvENToRIES
Inventories are stated at the lower of cost
or net realisable value. The first in, first out
or an average method of valuation is used.
For finished goods and work in progress,
cost includes directly attributable costs
and certain overhead expenses (including
depreciation). Selling expenses and certain
other overhead expenses (principally central
administration costs) are excluded. Net
realisable value is determined as estimated
Payments to defined contribution plans are
recognised in the income statement as they
fall due.
TAxATIoN
The current tax payable is based on taxable
profit for the year. Taxable profit differs from
profit as reported in the income statement
because it excludes items that are never
taxable or deductible. The Group’s current
tax assets and liabilities are calculated using
tax rates that have been enacted or
substantively enacted by the balance
sheet date.
Deferred tax is provided using the balance
sheet liability method, providing for temporary
differences between the carrying amounts
of assets and liabilities for financial reporting
purposes and the amounts used for taxation
purposes. Deferred tax assets are recognised
to the extent that it is probable that taxable
profit will be available against which the asset
can be utilised. This requires judgements to
be made in respect of the availability of future
taxable income.
No deferred tax asset or liability is recognised
in respect of temporary differences associated
with investments in subsidiaries, branches
and joint ventures where the Group is able to
control the timing of reversal of the temporary
differences and it is probable that the
temporary differences will not reverse in
the foreseeable future.
The Group’s deferred tax assets and liabilities
are calculated using tax rates that are expected
to apply in the period when the liability is
settled or the asset realised based on tax
rates that have been enacted or substantively
enacted by the balance sheet date.
Accruals for tax contingencies require
management to make judgements and
estimates of ultimate exposures in relation
to tax audit issues. Tax benefits are not
recognised unless the tax positions will
probably be sustained. Once considered
to be probable, management reviews each
material tax benefit to assess whether
a provision should be taken against full
recognition of that benefit on the basis of
potential settlement through negotiation and/
or litigation. All provisions are included in
current liabilities. Any recorded exposure to
interest on tax liabilities is provided for in the
tax charge. (See Note 25 for further details.)
SHARE-bASEd pAymENTS
All plans are assessed and have been
classified as equity settled. The grant date
fair value of employee share option awards is
generally calculated using the Black-Scholes
Intangible assets relating to products in
development (both internally generated and
externally acquired) are subject to impairment
testing at each balance sheet date. All
intangible assets are tested for impairment
when there are indications that the carrying
value may not be recoverable. Any impairment
losses are recognised immediately in the
income statement.
buSINESS CombINATIoNS ANd goodWIll
On the acquisition of a business, fair values
are attributed to the identifiable assets and
liabilities and contingent liabilities unless the
fair value cannot be measured reliably in which
case the value is subsumed into goodwill.
Where fair values of acquired contingent
liabilities cannot be measured reliably, the
assumed contingent liability is not recognised
but is disclosed in the same manner as other
contingent liabilities. Goodwill is the difference
between consideration paid and the fair value
of net assets acquired.
Goodwill arising on acquisitions is capitalised
and subject to an impairment review, both
annually and when there is an indication that
the carrying value may not be recoverable.
Between 1 January 1998 and 31 December
2002, goodwill was amortised over its
estimated useful life; such amortisation
ceased on 31 December 2002.
The Group’s policy up to and including
1997 was to eliminate goodwill arising upon
acquisitions against reserves. Under IFRS 1
‘First-time Adoption of International Financial
Reporting Standards’ and IFRS 3 ‘Business
Combinations’, such goodwill will remain
eliminated against reserves.
EmployEE bENEFITS
The Group accounts for pensions and other
employee benefits (principally healthcare)
under IAS 19 ‘Employee Benefits’. In respect
of defined benefit plans, obligations are
measured at discounted present value whilst
plan assets are measured at fair value. The
operating and financing costs of such plans
are recognised separately in the income
statement; current service costs are spread
systematically over the lives of employees
and financing costs are recognised in full in
the periods in which they arise. Actuarial
gains and losses are recognised immediately
in the statement of recognised income
and expense.
Where the calculation results in a benefit to
the Group, the recognised asset is limited
to the present value of any available future
refunds from the plan or reductions in future
contributions to the plan.
105
FINANCIAL STATEMENTS
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
effective interest rate method at each balance
sheet date. Changes in carrying value are
recognised in the income statement.
dERIvATIvES
Derivatives are initially measured at fair value
(with direct transaction costs being included
in the income statement as an expense) and
are subsequently remeasured to fair value at
each balance sheet date. Changes in carrying
value are recognised in the income statement.
FoREIgN CuRRENCIES
Foreign currency transactions, being
transactions denominated in a currency other
than an individual Group entity’s functional
currency, are translated into the respective
functional currencies of individual Group
entities at average rates for the relevant
monthly accounting periods, which
approximate to actual rates.
Monetary assets, arising from foreign
currency transactions, are retranslated at
exchange rates prevailing at the date of the
balance sheet. Exchange gains and losses
on loans and on short term foreign currency
borrowings and deposits are included within
net interest payable. Exchange differences
on all other foreign currency transactions are
taken to operating profit in the individual
Group entity’s accounting records.
Non-monetary items arising from foreign
currency transactions are not retranslated in
the individual Group entity’s accounting records.
In the Consolidated Financial Statements,
income statement items for Group entities
with a functional currency other than US
dollars, are translated into US dollars at
average exchange rates, which approximate
to actual rates, for the relevant accounting
periods. Assets and liabilities are translated
at US exchange rates prevailing at the date
of the Group balance sheet. Exchange
differences arising on consolidation are taken
to equity via the statement of recognised
income and expense.
Exchange differences arising on retranslation
of net investments in subsidiaries and of
foreign currency loans which hedge these
net investments, are taken directly to equity
via the statement of recognised income and
expense in the Consolidated Financial
Statements. Gains and losses accumulated
in the translation reserve will be recycled to
the income statement when the foreign
operation is sold.
remeasured to fair value at each balance
sheet date. Changes in carrying value due
to changes in exchange rates or impairments
are recognised in the income statement.
All other changes in fair value are recognised
as income or expense directly in reserves.
Impairments are recorded in the income
statement when there is a decline in the
value of an investment that is deemed to
be other than temporary. On disposal of
the investment, the cumulative income or
expense recognised in reserves is recognised
as part of the gain or loss on disposal in the
income statement.
bANk ANd oTHER boRRoWINgS
The Group uses derivatives, principally interest
rate swaps, to hedge the interest rate exposure
inherent in a portion of its fixed interest rate
debt. In such cases the Group will either
designate the debt as fair value through profit
or loss when certain criteria are met or as the
hedged item under a fair value hedge.
If the debt instrument is designated as fair
value through profit or loss, the debt is initially
measured at fair value (with direct transaction
costs being included in the income statement
as an expense) and is remeasured to fair value
at each balance sheet date with changes in
carrying value being recognised in the income
statement (along with changes in the fair value
of the related derivative). Such a designation
has been made where this significantly
reduces an accounting mismatch which
would result from recognising gains and
losses on different bases.
If the debt is designated as the hedged item
under a fair value hedge, the debt is initially
measured at fair value (with direct transaction
costs being amortised over the life of the
bonds), and is remeasured for fair value
changes in respect of the hedged risk at
each balance sheet date with changes in
carrying value being recognised in the income
statement (along with changes in the fair
value of the related derivative).
If certain criteria are met, non-US dollar
denominated loans are designated as net
investment hedges of foreign operations
and exchange differences arising from the
retranslation are recognised directly in
reserves to the extent that the hedge is
effective. All other exchange differences
giving rise to changes in the carrying value
of foreign currency loans and overdrafts are
recognised in the income statement.
Other interest bearing loans are initially
measured at fair value (including direct
transaction costs) and are subsequently
remeasured to amortised cost using the
selling price less all estimated costs of
completion and costs to be incurred in
selling and distribution.
Write downs of inventory occur in the general
course of business and are included in cost
of sales in the income statement.
TRAdE ANd oTHER RECEIvAblES
Trade and other receivables are recognised
initially at fair value. Subsequent to initial
recognition they are measured at amortised
cost using the effective interest rate method,
less any impairment losses.
TRAdE ANd oTHER pAyAblES
Trade and other payables are recognised
initially at fair value. Subsequent to initial
recognition they are measured at amortised
cost using the effective interest rate method.
FINANCIAl INSTRumENTS
The Group’s financial instruments include
interests in leases and rights and obligations
under employee benefit plans which are dealt
with in specific accounting policies.
The Group’s other financial instruments include:
Cash and cash equivalents >
Fixed deposits >
Other investments >
Bank and other borrowings >
Derivatives >
CASH ANd CASH EquIvAlENTS
Cash and cash equivalents comprise cash
in hand, current balances with banks and
similar institutions and highly liquid investments
with maturities of three months or less when
acquired. They are readily convertible into
known amounts of cash and are held at
amortised cost.
FIxEd dEpoSITS
Fixed deposits, comprising principally funds
held with banks and other financial institutions,
are initially measured at fair value (including
direct transaction costs) and are subsequently
remeasured to amortised cost using the
effective interest rate method at each balance
sheet date. Changes in carrying value are
recognised in the income statement.
oTHER INvESTmENTS
Where investments have been classified as
held for trading, they are measured initially
at fair value and subsequently at fair value.
Changes in fair value are recognised in the
income statement.
In all other circumstances, the investments
are initially measured at fair value (including
direct transaction costs) and are subsequently
106
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
Amendments to IAS 32 ‘Financial Instruments:
Presentation’ and IAS 1 ‘Presentation of
Financial Statements – Puttable Financial
Instruments and Obligations Arising on
Liquidation’ was issued in February 2008.
The amendments require puttable instruments,
and instruments that impose on the entity
an obligation to deliver to another party a pro
rata share of net assets of the entity only on
liquidation, to be classified as equity if certain
conditions are met. The amendments are
effective for annual periods beginning on or
after 1 January 2009 and will be applied
retrospectively. Adoption of the amendments
is not expected to have any impact upon
the net results, net assets or disclosures
of AstraZeneca.
A revised IFRS 3 ‘Business Combinations’ was
issued in January 2008. The following changes
will be relevant to the Group’s operations:
Contingent consideration will be measured >
at fair value, with subsequent changes
to the fair value being recognised in the
income statement.
Transaction costs, other than share >
and debt issue costs, will be expensed
as incurred.
Any pre-existing interest in the acquiree will >
be measured at fair value with the gain or
loss recognised in the income statement.
Any non-controlling (minority) interest will >
be measured at either fair value, or at its
proportionate interest in the identifiable
assets and liabilities of the acquiree, on
a transaction by transaction basis.
The revised Standard is effective for business
combinations on or after 1 January 2010 and
will be applied prospectively from that date.
An amendment to IAS 27 ‘Consolidated and
Separate Financial Statements (2008)’ was
issued in January 2008. The amendment
requires changes in ownership interests in
a subsidiary, while maintaining control, to be
recognised as an equity transaction. If control
of a subsidiary is lost, any retained interest
is measured at fair value with the gain or
loss recognised in the income statement.
The amendment is effective for accounting
periods beginning on or after 1 July 2009
and will not have a significant impact upon
the net results, net assets or disclosures
of AstraZeneca.
Amendments to IFRS 2Share-based Payment
– Vesting Conditions and Cancellations’ clarify
the definition of vesting conditions and
introduces the concept of non-vesting
INTERNATIoNAl ACCouNTINg TRANSITIoN
On transition to using adopted IFRS in the
year ended 31 December 2005, the
Company took advantage of several optional
exemptions available in IFRS 1 ‘First-time
Adoption of International Financial Reporting
Standards’. The major impacts which are of
continuing importance are detailed below:
Business combinations – IFRS 3 ‘Business >
Combinations’ has been applied from
1 January 2003, the date of transition,
rather than being applied fully retrospectively.
As a result, the combination of Astra and
Zeneca is still accounted for as a merger,
rather than through purchase accounting.
If purchase accounting had been
adopted, Zeneca would have been
deemed to have acquired Astra.
Cumulative exchange differences – the >
Group chose to set the cumulative
exchange difference reserve at 1 January
2003 to zero.
ACCouNTINg STANdARdS ANd INTERpRETATIoNS
ISSuEd buT NoT yET AdopTEd
IFRS 8 ‘Operating Segments’ was issued in
November 2006. It requires the identification
of operating segments based on internal
reporting to the chief operating decision
maker and extends the scope and disclosure
requirements of IAS 14 ‘Segmental Reporting’.
It is effective for annual periods beginning
on or after 1 January 2009. The adoption of
IFRS 8 will not have a significant impact upon
the net results, net assets or disclosures of
AstraZeneca.
A revised IAS 23 ‘Borrowing Costs’ was
issued in March 2007. It removes the option
of immediately recognising as an expense
borrowing costs that relate to assets that
take a substantial period of time to prepare
for use and therefore requires an entity to
capitalise borrowing costs as part of the
cost of such assets. The revised Standard is
effective for annual periods beginning on
or after 1 January 2009 and will be applied
prospectively from that date. The adoption of
these amendments to IAS 23 is not expected
to have a material effect upon the net results
or net assets of AstraZeneca going forward.
A revised IAS 1 ‘Presentation of Financial
Statements’ was issued in September 2007.
It revises the presentation of non-owner
changes in equity and introduces a statement
of comprehensive income. It is effective
for annual periods beginning on or after
1 January 2009. The adoption of these
amendments to IAS 1 will not have a significant
impact upon the net results or net assets
of AstraZeneca.
lITIgATIoN ANd ENvIRoNmENTAl lIAbIlITIES
Through the normal course of business,
AstraZeneca is involved in legal disputes,
the settlement of which may involve cost
to the Group. Provision is made where an
adverse outcome is probable and associated
costs, including related legal costs, can be
estimated reliably. In other cases, appropriate
disclosures are included.
Where it is considered that the Group is more
likely than not to prevail, legal costs involved
in defending the claim are charged to the
income statement as they are incurred.
Where it is considered that the Group has
a valid contract which provides the right to
reimbursement (from insurance or otherwise)
of legal costs and/or all or part of any loss
incurred or for which a provision has been
established, the best estimate of the amount
expected to be received is recognised as
an asset.
AstraZeneca is exposed to environmental
liabilities relating to its past operations,
principally in respect of soil and groundwater
remediation costs. Provisions for these costs
are made when there is a present obligation
and where it is probable that expenditure on
remedial work will be required and a reliable
estimate can be made of the cost. Provisions
are discounted where the effect is material.
ImpAIRmENT
The carrying value of non-financial assets,
other than inventories and deferred tax
assets are reviewed at least annually to
determine whether there is any indication of
impairment. For goodwill, intangible assets
under development and for any other assets
where such indication exists, then the asset’s
recoverable amount is estimated based on
the greater of its value in use and its fair value
less cost to sell. In assessing value in use,
the estimated future cash flows, adjusted
for the risks specific to each asset, are
discounted to their present value using a
discount rate that reflects current market
assessments of the time value of money and
the general risks affecting the pharmaceutical
industry. For the purpose of impairment
testing, assets are grouped together into the
smallest group of assets that generates cash
inflows from continuing use that are largely
independent of the cash flows of other
assets. Impairment losses are recognised
in the income statement.
107
FINANCIAL STATEMENTS
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
conditions. The amendments are effective
for accounting periods beginning on or after
1 January 2009 and are not expected to have
a significant impact upon the net results, net
assets or disclosures of AstraZeneca.
The amendment to IAS 39 ‘Financial
Instruments: Recognition and Measurement:
Eligible Hedged Items’ deals with two situations
where diversity in practice exists on the
designation of inflation as a hedged risk
and the treatment of ‘one-sided’ risks on
hedged items. The amendment is effective
for accounting periods beginning on or
after 1 July 2009. The amendment is not
expected to have a significant impact upon
the net results, net assets or disclosures
of AstraZeneca.
IFRS 8 ‘Operating Segments’ was endorsed
by the EU during 2007. The amendments to
IAS 23, IAS 1 and IFRS 2 were endorsed by
the EU in 2008. The remaining standards and
amendments have not yet been endorsed by
the EU.
The following IFRIC interpretations have been
issued but are not yet adopted by AstraZeneca:
IFRIC 13 ‘Customer Loyalty Programmes’
and IFRIC 16 ‘Hedges of a Net Investment in
a Foreign Operation’. The interpretations are
effective for accounting periods commencing
on 1 July 2008 and 1 October 2008
respectively. IFRIC 13 was endorsed by the
EU in 2008. IFRIC 16 has yet to be endorsed
by the EU. Neither interpretation is expected
to have a significant impact upon adoption.
108
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
NoTES To ThE FINANCIAL STATEMENTS
1 opERATINg pRoFIT
Operating profit includes the following items:
oTHER opERATINg INComE ANd ExpENSE
2008 2007 2006
$m $m $m
Royalties
1
113 236 327
Net gain on disposal of property, plant and equipment 6 9 2
Net loss on disposal of intangible assets (17) (1) (1)
Gains on divestments of non-core products 118 192 161
Other income 304 310 115
Other expense (18) (80)
Other operating income and expense 524 728 524
1
Royalty income is net of amortisation of intangible assets relating to royalty income streams and in 2008 the impairment of the HPV royalty intangible asset ($91m).
RESTRuCTuRINg ANd SyNERgy CoSTS
During 2008 the Group continued the restructuring and synergy programmes announced in 2007. In addition, the Group announced further
programmes during the year. The tables below show the costs that have been charged in respect of these programmes to the income
statement by cost category and type. Severance provisions are detailed in Note 18.
2008 2007 2006
$m
$m $m
Cost of sales 405 415
Research and development 166 73
Selling, general and administrative expenses 310 478
Total charge 881 966
2008 2007 2006
$m
$m $m
Severance costs 499 678
Accelerated depreciation and impairment 219 203
Other 163 85
Total charge 881 966
The total charge in respect of the Global Supply Chain productivity initiative is anticipated to be around $1,250m.
In aggregate, research and development restructuring costs of around $300m are expected.
The total charge in respect of selling and marketing and business infrastructure is anticipated to be around $1,400m.
2 FINANCE INComE ANd ExpENSE
2008 2007 2006
$m $m $m
Finance income
Returns on fixed deposits and equity securities 15 52 29
Returns on short-term deposits 127 298 330
Expected return on post-employment defined benefit plan assets 584 573 518
Fair value gains on debt, interest rate swaps and investments 128 3 6 11
Total finance income 854 959 888
Finance expense
Interest on debt and commercial paper (664) (513) (59)
Interest on overdrafts and other financing costs (50) (9) (13)
Interest on post-employment defined benefit plan liabilities (589) (539) (475)
Fair value charges on debt, interest rate swaps and investments (2) (6)
Net exchange losses (12) (3) (14)
Total finance expense (1,317) (1,070) (561)
Net finance (expense)/income (463) (111) 327
109
FINANCIAL STATEMENTS
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
2 FINANCE INComE ANd ExpENSE CoNTINuEd
The amount of exchange gains and losses recognised in income, other than those arising on financial instruments measured at fair value
through profit or loss in accordance with IAS 39 (see Note 16), is a loss of $12m (2007: $3m; 2006: $14m).
3 TAxATIoN
Taxation recognised in the income statement is as follows:
2008 2007 2006
$m $m $m
Current tax expense
Current year 2,946 1,890 2,431
Adjustment for prior years 130 261 270
3,076 2,151 2,701
Deferred tax expense
Origination and reversal of temporary differences (486) 379 (81)
Adjustment to prior years (39) (174) (140)
(525) 205 (221)
Total taxation expense in the income statement 2,551 2,356 2,480
Taxation has been provided at current rates on the profits earned for the periods covered by the Group Financial Statements. The 2008, 2007
and 2006 prior period current tax adjustments relate mainly to tax accrual to tax return adjustments, an increase in provisions in respect of a
number of transfer pricing audits and double tax relief. The 2008, 2007 and 2006 prior year deferred tax credits relate to tax accrual to tax
return adjustments and the recognition of previously unrecognised deferred tax assets. To the extent that dividends remitted from overseas
subsidiaries, joint ventures and associates are expected to result in additional taxes, appropriate amounts have been provided for. No deferred
tax has been provided for unremitted earnings of Group companies overseas as these are considered permanently employed in the businesses
of these companies. Unremitted earnings may be liable to overseas taxes and/or UK taxation (after allowing for double taxation relief) if they were
to be distributed as dividends. The aggregate amount of temporary differences associated with investments in subsidiaries and branches for
which deferred tax liabilities have not been recognised totalled approximately $8,449m at 31 December 2008 (2007: $12,639m; 2006: $13,291m).
CoNSolIdATEd STATEmENT oF RECogNISEd INComE ANd ExpENSE
The current tax credit on consolidation exchange adjustments taken to reserves amounted to $20m in 2008 (2007: $32m; 2006: $62m).
The current tax credit on share-based payments amounted to $nil (2007: $1m; 2006: $36m). The deferred tax credit taken to reserves
amounted to $348m in 2008 (2007: $nil; 2006: $39m).
FACToRS AFFECTINg FuTuRE TAx CHARgES
As a group involved in worldwide operations, AstraZeneca is subject to several factors that may affect future tax charges, principally the levels
and mix of profitability in different jurisdictions, transfer pricing regulations and tax rates imposed. A number of material items currently under
audit and negotiation are set out in detail in Note 25.
TAx RECoNCIlIATIoN To uk STATuToRy RATE
The table shown below reconciles the UK statutory tax charge to the Group’s total tax charge.
2008 2007 2006
$m $m $m
Profit before tax 8,681 7,9 8 3 8 ,5 4 3
Notional taxation charge at UK corporation tax rate of 28.5%
1
(30% for 2007, 30% for 2006) 2,474 2,395 2,563
Differences in effective overseas tax rates (8) (105) (156)
Deferred tax income relating to reduction in Swedish, UK and other tax rates
2
(70) (57)
Unrecognised deferred tax asset (7) (1) (6)
Items not deductible for tax purposes 119 70 58
Items not chargeable for tax purposes (48) (33) (109)
Adjustments in respect of prior periods 91 87 130
Total tax charge for the year 2,551 2,356 2,480
1
The UK statutory tax rate was reduced from 30% to 28% effective from 1 April 2008 resulting in the effective tax rate for the Group for 2008 being 28.5%.
2
The 2008 item relates to the reduction in the Swedish statutory corporation tax rate from 28% to 26.3% effective from 1 January 2009. The majority of the 2007
item relates to the reduction in the UK statutory corporation tax rate referred to above.
110
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
3 TAxATIoN CoNTINuEd
dEFERREd TAx
Deferred tax assets and liabilities and the movements during the year, before offset of balances within countries, are as follows:
Losses
Pension Inter- and tax
Property, and post- company Deferred credits
plant and Intangible retirement inventory Untaxed Accrued Share capital carried
equipment assets benefits transfers reserves
1
expenses schemes gains forward Other Total
$m $m $m $m $m $m $m $m $m $m $m
Deferred tax assets at 1 January 2007 37 2 604 853 323 113 57 28 2,017
Deferred tax liabilities at 1 January 2007 (502) (819) (881) (99) (55) (2,356)
Net deferred tax balance at 1 January 2007
2
(465) (817) 604 853 (881) 323 113 (99) 57 (27) (339)
Income statement (130) 201 (99) (71) (225) 190 (45) 12 (96) 58 (205)
Statement of recognised income and expense 8 (8)
Acquisition of subsidiary undertaking
3
3 (2,973) 58 74 369 (29) (2,498)
Exchange (35) (5) 15 46 (65) 11 2 (1) (1) (33)
Net deferred tax balance at 31 December 2007
2
(627) (3,594) 528 886 (1,171) 598 62 (88) 330 1 (3,075)
Deferred tax assets at 31 December 2007 66 59 531 907 611 62 330 71 2,637
Deferred tax liabilities at 31 December 2007 (693) (3,653) (3) (21) (1,171) (13) (88) (70) (5,712)
Net deferred tax balance at 31 December 2007 (627) (3,594) 528 886 (1,171) 598 62 (88) 330 1 (3,075)
Income statement 122 375 24 55 (119) 37 43 12 (24) 525
Statement of recognised income and expense 340 9 (1) 348
Exchange 168 130 (113) (35) 199 (37) (14) 24 (7) (3) 312
Net deferred tax balance at 31 December 2008 (337) (3,089) 779 906 (1,091) 598 100 (64) 335 (27) (1,890)
Deferred tax assets at 31 December 2008 136 42 786 935 598 100 335 45 2,977
Deferred tax liabilities at 31 December 2008 (473) (3,131) (7) (29) (1,091) (64) (72) (4,867)
Net deferred tax balance at 31 December 2008 (337) (3,089) 779 906 (1,091) 598 100 (64) 335 (27) (1,890)
2008 2007 2006
Analysed in the balance sheet, after offset of balances within countries, as: $m $m $m
Deferred tax assets 1,236 1,044 1,220
Deferred tax liabilities (3,126) (4,119) (1,559)
Net deferred tax balance (1,890) (3,075) (339)
1
Untaxed reserves relate to taxable profits where the tax liability is deferred to later periods.
2
During 2008, the Group carried out a review of its deferred tax balances resulting in a reclassification of a deferred tax liability of $284m from property, plant and
equipment to intangible assets as at 31 December 2007 ($328m as at 1 January 2007).
3
The deferred tax liability of $2,498m relates to MedImmune, Inc. and other acquisitions.
uNRECogNISEd dEFERREd TAx ASSETS
Deferred tax assets of $80m have not been recognised in respect of deductible temporary differences (2007: $106m; 2006: $103m) because it
is not probable that future taxable profit will be available against which the Group can utilise the benefits therefrom.
111
FINANCIAL STATEMENTS
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
4 EARNINgS pER $0.25 oRdINARy SHARE
2008 2007 2006
Profit for the financial year attributable to equity holders ($m) 6,101 5,595 6,043
Basic earnings per Ordinary Share $4.20 $3.74 $3.86
Diluted earnings per Ordinary Share $4.20 $3.73 $3.85
Weighted average number of Ordinary Shares in issue for basic earnings (millions) 1,453 1,495 1,564
Dilutive impact of share options outstanding (millions) 3 6
Diluted weighted average number of Ordinary Shares in issue (millions) 1,453 1,498 1,570
There are no options, warrants or rights outstanding in respect of unissued shares except for employee share option schemes. The number of
options outstanding and the weighted average exercise price of these options is shown in Note 24. The earnings figures used in the calculations
above are post-tax and are unchanged for diluted earnings per Ordinary Share.
5 SEgmENT INFoRmATIoN
The Group’s activities are in one business segment, pharmaceuticals. There are no other significant classes of business, either singularly or
in aggregate.
gEogRApHIC AREAS
The tables below show information by geographic area and, for revenue and property, plant and equipment, material countries. The figures
show the revenue, operating profit and profit before tax made by companies located in that area/country, together with segment assets,
segment assets acquired, net operating assets and property, plant and equipment owned by the same companies; export sales and the
related profit are included in the area/country from which those sales were made.
Revenue
2008 2007 2006
$m $m $m
UK
External 1,910 1,981 1,686
Intra-Group 8,460 6,506 6,123
10,370 8 ,4 87 7,8 0 9
Continental Europe
Belgium 380 387 344
France 1,945 1,806 1,641
Germany 1,225 1,16 4 1,113
Italy 1,145 1,111 1,075
Spain 832 840 723
Sweden 1,135 985 843
Others 2,696 2,291 1,929
Intra-Group 3,895 4,123 4,314
13,253 12,707 11,9 82
The Americas
Canada 1,269 1,145 1,031
US 13,657 13,404 12,381
Others 1,155 872 673
Intra-Group 1,169 786 351
17, 250 16,207 14,436
Asia, Africa & Australasia
Australia 763 631 481
Japan 1,861 1,585 1,433
China 627 403 224
Others 1,001 954 898
Intra-Group 78 56 49
4,330 3,629 3,085
Continuing operations 45,203 41,030 37,312
Intra-Group eliminations (13,602) (11,471) (10,837)
31,601 29,559 26,475
Export sales from the UK totalled $9,439m for the year ended 31 December 2008 (2007: $7,546m; 2006: $7,012m).
Intra-Group pricing is determined on an arm’s length basis.
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ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
5 SEgmENT INFoRmATIoN CoNTINuEd
Operating profit Profit before tax
2008 2007 2006 2008 2007 2006
Profit from $m $m $m $m $m $m
UK 2,907 2,060 1,852 2,612 1,828 1,936
Continental Europe 3,136 2,894 3,648 3,233 2,964 3,700
The Americas 2,705 2,734 2,437 2,440 2,781 2,627
Asia, Africa & Australasia 396 406 279 396 410 280
Continuing operations 9,144 8,094 8,216 8,681 7,983 8,543
Total assets
2008 2007 2006
$m $m $m
UK 9,270 12,003 13,346
Continental Europe 6,229 7, 311 6 ,9 37
The Americas 26,215 24,175 6 ,33 4
Asia, Africa & Australasia 2,489 2,217 1,950
Income tax receivable 2,581 2,251 1,365
Continuing operations 46,784 47,957 29,932
Assets acquired
1
Net operating assets
2
2008 2007 2006 2008 2007 2006
$m $m $m $m $m $m
UK 440 929 2,282 4,234 5,043 4,977
Continental Europe 295 624 440 3,683 4,972 4,820
The Americas 3,252 17,858 292 21,033 19,742 2,081
Asia, Africa & Australasia 67 48 50 1,732 1,510 1,270
Continuing operations 4,054 19,459 3,064 30,682 31,267 13,148
1
Included in ‘assets acquired’ are those assets that are expected to be used during more than one period (property, plant and equipment, goodwill and
intangible assets).
2
Net operating assets’ exclude short-term investments, cash, short-term borrowings, loans, retirement benefit obligations and non-operating receivables
and payables.
Property, plant and equipment
2008 2007 2006
$m $m $m
UK 1,750 2,490 2,508
Sweden 1,722 2,204 2,104
US 2,200 1,915 1,172
Rest of the world 1,371 1,689 1,669
Continuing operations 7,04 3 8,298 7,453
gEogRApHIC mARkETS
The table below shows revenue in each geographic market in which customers are located.
2008 2007 2006
$m $m $m
UK 994 1,003 850
Continental Europe 9,937 9,138 8,0 53
The Americas 15,945 15,459 14,213
Asia, Africa & Australasia 4,725 3,959 3,359
Continuing operations 31,601 29,559 26,475
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FINANCIAL STATEMENTS
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
6 pRoduCT REvENuE INFoRmATIoN
2008 2007 2006
$m $m $m
Gastrointestinal:
Nexium 5,200 5,216 5,182
Losec/Prilosec 1,055 1,143 1,371
Others 89 84 78
Total Gastrointestinal 6,344 6,443 6,631
Cardiovascular:
Crestor 3,597 2,796 2,028
Seloken/Toprol-X L 807 1,438 1,795
Atacand 1,471 1, 287 1,110
Zestril 236 295 307
Plendil 268 271 275
Others 584 599 603
Total Cardiovascular 6,963 6 ,68 6 6,118
Respiratory:
Symbicort 2,004 1,575 1,184
Pulmicort 1,495 1,454 1,292
Rhinocort 322 354 360
Oxis 71 86 88
Others 236 242 227
Total Respiratory 4,128 3,711 3,151
Oncology:
Arimidex 1,857 1,730 1,508
Casodex 1,258 1,335 1,206
Zoladex 1,138 1,104 1,008
Iressa 265 238 237
Faslodex 249 214 186
Nolvadex 85 83 89
Abraxane
®
64 62 18
Ethyol 28 43
Others 10 10 10
Total Oncology 4,954 4,819 4,262
Neuroscience:
Seroquel 4,452 4,027 3,416
Local anaesthetics 605 557 529
Zomig 448 434 398
Diprivan 278 263 304
Others 54 59 57
Total Neuroscience 5,837 5,340 4,704
Infection and Other:
Merrem 897 773 604
Synagis 1,230 618
FluMist 104 53
Other Products 220 270 271
Total Infection and Other 2,451 1,714 875
Aptium Oncology 395 402 374
Astra Tech 529 444 360
Total 31,601 29,559 26,475
114
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
7 pRopERTy, plANT ANd EquIpmENT
Total property,
Land and Plant and Assets in course plant and
buildings equipment of construction equipment
$m $m $m $m
Cost
At 1 January 2006 4,490 8,035 480 13,005
Capital expenditure 23 196 577 796
Additions through business combinations 26 26
Transfer of assets into use 154 494 (648)
Disposals and other movements (35) (300) (3) (338)
Exchange adjustments 450 912 57 1,419
At 31 December 2006 5,082 9,363 463 14,908
Capital expenditure 53 304 812 1,169
Additions through business combinations 302 122 176 600
Transfer of assets into use 151 470 (621)
Disposals and other movements (23) (555) (16) (594)
Exchange adjustments 254 470 28 752
At 31 December 2007 5,819 10,174 842 16,835
Capital expenditure 49 239 825 1,113
Transfer of assets into use 275 404 (679)
Disposals and other movements (123) (558) (25) (706)
Exchange adjustments (803) (1,725) (100) (2,628)
At 31 December 2008 5,217 8,534 863 14,614
Depreciation
At 1 January 2006 1,320 4,700 6,020
Charge for year 203 747 950
Impairment 6 47 53
Disposals and other movements (21) (277) (298)
Exchange adjustments 148 582 730
At 31 December 2006 1,656 5,799 7,455
Charge for year 227 849 1,076
Impairment 39 65 2 106
Disposals and other movements (3) (498) (1) (502)
Exchange adjustments 96 306 402
At 31 December 2007 2,015 6,521 1 8,537
Charge for year 247 812 1,059
Impairment 91 32 123
Disposals and other movements (120) (529) (2) (651)
Exchange adjustments (303) (1,192) (2) (1,497)
At 31 December 2008 1,930 5,644 (3) 7,571
Net book value
At 31 December 2006 3,426 3,564 463 7,453
At 31 December 2007 3,804 3,653 841 8,298
At 31 December 2008 3,287 2,890 866 7,043
Impairment charges in 2008 are attributable to the productivity initiatives in the global supply chain in France and research and development
in Canada. These costs were recognised in cost of sales and research and development in the income statement.
Impairment charges in 2007 are attributable to the productivity initiatives in the global supply chain in Germany and the write-down of business
support assets. These costs were recognised in cost of sales and general and administrative expenses in the income statement.
Impairment charges in 2006 are attributable to the write-down of assets in relation to the termination of NXY-059 and the write-down of assets
in association with Toprol-XL, resulting from the introduction of generic competition in the US. The charges were recognised in cost of sales in
the income statement.
115
FINANCIAL STATEMENTS
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
7 pRopERTy, plANT ANd EquIpmENT CoNTINuEd
2008 2007 2006
$m $m $m
The net book value of land and buildings comprised:
Freeholds 3,287 3,804 3,421
Short leases 5
3,287 3,804 3,426
8 goodWIll
2008 2007 2006
$m $m $m
Cost
At 1 January 10,225 1,430 1,280
Additions through business combinations 8,757 116
Exchange adjustments (14) 38 34
At 31 December 10,211 10,225 1,430
Amortisation and impairment losses
At 1 January 341 333 327
Exchange adjustments (4) 8 6
At 31 December 337 341 333
Net book value at 31 December 9,874 9,884 1,097
SIgNIFICANT ASSETS
Carrying Remaining
value amortisation
Description $m period
Goodwill arising from the acquisition of MedImmune Goodwill 8,757 Not amortised
Goodwill in the US Goodwill 707 Not amortised
For the purpose of impairment testing of goodwill, the Group is regarded as a single cash-generating unit.
The recoverable amount is based on value in use using discounted risk-adjusted projections of the Group’s pre-tax cash flows over 10 years,
a period reflecting the average patent-protected lives of our current products. The projections include assumptions about product launches,
competition from rival products and pricing policy as well as the possibility of generics entering the market. In setting these assumptions we
consider our past experience, external sources of information (including information on expected increases and ageing of the populations in
our established markets and the expanding patient population in newer markets), our knowledge of competitor activity and our assessment
of future changes in the pharmaceutical industry. The 10 year period is covered by internal budgets and forecasts. Given that internal budgets
and forecasts are prepared for all projections, no general growth rates are used to extrapolate internal budgets and forecasts for the purposes
of determining value in use. No terminal value is included as the cash flows are more than sufficient to establish whether an impairment exists.
In arriving at value in use, we disaggregate our projected pre-tax cash flows into groups reflecting similar risks and tax effects. For each group
of cash flows we use an appropriate discount rate reflecting those risks and tax effects. In arriving at the appropriate discount rate for each
group of cash flows, we adjust AstraZeneca’s post-tax weighted average cost of capital (7.6% for 2008) to reflect the impact of risks and tax
effects. The weighted average pre-tax discount rate we used was approximately 11%.
As a cross check, we compare our market capitalisation to the book value of our net assets and this indicates significant surplus at
31 December 2008.
No goodwill impairment was identified.
The Group has also performed sensitivity analysis calculations on the projections used and discount rate applied. The Directors have concluded
that, given the significant headroom that exists, and the results of the sensitivity analysis performed, there is no significant risk that reasonable
changes in any key assumptions would cause the carrying value of goodwill to exceed its value in use.
116
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
9 INTANgIblE ASSETS
Product,
marketing and Software
distribution Other development
rights intangibles costs Total
$m $m $m $m
Cost
At 1 January 2006 2,803 503 649 3,955
Additions – through business combinations 1,260 281 1,541
Additions – separately acquired 413 51 121 585
Disposals (675) (4) (679)
Exchange adjustments 372 79 16 467
At 31 December 2006 4,173 910 786 5,869
Additions – through business combinations 6,946 1,477 8,423
Additions – separately acquired 299 33 178 510
Disposals (52) (82) (134)
Exchange adjustments 183 47 12 242
At 31 December 2007 11,549 2,385 976 14,910
Additions – separately acquired 2,743 20 178 2,941
Disposals (33) (30) (63)
Exchange adjustments (770) (197) (133) (1,100)
At 31 December 2008 13,522 2,175 991 16,688
Amortisation and impairment losses
At 1 January 2006 1,433 357 406 2,196
Amortisation for year 250 25 50 325
Disposals (14) (4) (18)
Impairment 17 17
Exchange adjustments 190 48 4 242
At 31 December 2006 1,859 443 460 2,762
Amortisation for year 364 112 78 554
Disposals (52) (81) (133)
Impairment 98 22 120
Exchange adjustments 104 32 4 140
At 31 December 2007 2,373 528 542 3,443
Amortisation for year 529 182 96 807
Disposals (9) (10) (19)
Impairment 516 91 24 631
Exchange adjustments (357) (104) (36) (497)
At 31 December 2008 3,061 688 616 4,365
Net book value
At 31 December 2006 2,314 467 326 3,107
At 31 December 2007 9,176 1,857 434 11,467
At 31 December 2008 10,461 1,487 375 12,323
Other intangibles consist mainly of licensing and rights to contractual income streams.
AddITIoNS IN THE yEAR
Included in additions in the year is an amount of $2.6bn for a payment made to Merck & Co., Inc (‘Merck’). The payments consisted of payments
for product rights and non-refundable deposits. Further details of this payment, including the background to the transaction and further
payments that may be made under the agreements between AstraZeneca and Merck are included in Note 25.
117
FINANCIAL STATEMENTS
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
9 INTANgIblE ASSETS CoNTINuEd
Amortisation charges are recognised in the income statement as follows:
Product, Software
marketing and Other development
distribution rights intangibles costs Total
$m $m $m $m
Year ended 31 December 2008
Cost of sales 39 39
Research and development 10 10
Selling, general and administrative costs 480 35 96 611
Other operating income and expense 147 147
529 182 96 807
Year ended 31 December 2007
Selling, general and administrative costs 364 27 78 469
Other operating income and expense 85 85
364 112 78 554
Year ended 31 December 2006
Selling, general and administrative costs 250 13 50 313
Other operating income and expense 12 12
250 25 50 325
Impairment charges are recognised in the income statement as follows:
Product, Software
marketing and Other development
distribution rights intangibles costs Total
$m $m $m $m
Year ended 31 December 2008
Cost of sales 115 115
Research and development 144 144
Selling, general and administrative costs 257 24 281
Other operating income and expense 91 91
516 91 24 631
Year ended 31 December 2007
Research and development 98 22 120
Year ended 31 December 2006
Research and development 17 17
AmoRTISATIoN ANd ImpAIRmENT CHARgES
The 2008 impairment of product, marketing and distribution rights result, in part, from the settlement of the Pulmicort Respules patent
litigation with Teva ($115m) and the “at risk” launch of a generic competitor to Ethyol ($257m). The write down in value of the intangible
assets in relation to these products was determined based on value in use calculations using discounted risk-adjusted projections of the
expected products’ cash flows over a period reflecting the patent-protected lives of the individual products. The full period of projections
are covered by internal budgets and forecasts. In arriving at the appropriate discount rate to use for each product, we adjust AstraZeneca’s
post-tax weighted average cost of capital (7.6% for 2008) to reflect the impact of risks and tax effects specific to the individual products.
The weighted average pre-tax discount rate we used was approximately 14%.
The remaining $144m impairment of product, marketing and distribution rights results from the termination of development projects during
the year.
The 2008 impairment of other intangibles results from a reassessment of the future royalties expected to be received relating to the HPV
cervical cancer vaccine. This impairment charge was determined using value in use calculations applying the same considerations as applied
to the write down of Pulmicort Respules and Ethyol detailed above.
The impairment in 2007 was in relation to the termination of a product in development acquired with MedImmune and four
collaboration agreements.
The impairment in 2006 was in relation to the termination of NXY-059 and a collaboration agreement.
118
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
9 INTANgIblE ASSETS CoNTINuEd
SIgNIFICANT ASSETS
Carrying Remaining
value amortisation
Description $m period
Intangible assets arising from joint venture with Merck
1
Product, marketing and distribution rights 262 5 and 9 years
Advance payment
1
Product, marketing and distribution rights 528 10 years
Partial retirement (non–refundable deposit)
1
Product, marketing and distribution rights 1,656 Not amortised
Partial retirement
1
Product, marketing and distribution rights 840 13-19 years
Intangible assets arising from the acquisition of CAT Product, marketing and distribution rights 398 7 and 12 years
2
Intangible assets arising from the acquisition of KuDOS Product, marketing and distribution rights 285 Not amortised
2
RSV franchise assets arising on acquisition of MedImmune
3
Product, marketing and distribution rights 5,161 17-23 years
2
Intangible assets arising from the acquisition of MedImmune
3
Licensing and contractual income 1,103 1-12 years
1
These assets are associated with the restructuring of the joint venture with Merck & Co., Inc. Further information can be found in Note 25.
2
Assets in development are not amortised but are tested annually for impairment.
3
An allocation of the cost of these assets to Therapy Area is given in Note 22.
10 oTHER INvESTmENTS
2008 2007 2006
$m $m $m
Non-current investments
Loans and receivables at fair value through profit or loss 37
Equity securities available for sale 156 182 82
156 182 119
Current investments
Equity securities held for trading 50 31 26
Fixed deposits 54 60 559
Derivative financial instruments 284 86 72
388 177 657
Impairment charges of $25m in respect of available for sale securities are included in other operating income and expense in the income
statement (2007: $18m; 2006: $nil).
11 INvENToRIES
2008 2007 2006
$m $m $m
Raw materials and consumables 409 579 541
Inventories in process 631 806 778
Finished goods and goods for re-sale 596 734 931
1,636 2,119 2,25 0
Inventory write-offs in the year amounted to $51m (2007: $95m; 2006: $137m).
119
FINANCIAL STATEMENTS
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
12 TRAdE ANd oTHER RECEIvAblES
2008 2007 2006
$m $m $m
Amounts due within one year
Trade receivables 5,657 5,415 4,340
Less: Amounts provided for doubtful debts (Note 16) (99) (89) (52)
5,558 5,326 4,288
Other receivables 978 593 462
Prepayments and accrued income 552 510 578
7,0 88 6,429 5,328
Amounts due after more than one year
Other receivables 44 54 44
Prepayments and accrued income 129 185 189
173 239 233
7,261 6,668 5,561
13 CASH ANd CASH EquIvAlENTS
2008 2007 2006
$m $m $m
Cash at bank and in hand 1,039 1,403 684
Short-term deposits 3,247 4,464 6,419
Cash and cash equivalents 4,286 5, 86 7 7,10 3
Unsecured bank overdrafts (163) (140) (114)
Cash and cash equivalents in the cash flow statement 4,123 5,727 6,989
The Group’s insurance subsidiaries hold cash and short-term investments totalling $400m (2007: $347m; 2006: $320m), of which $278m
(2007: $257m; 2006: $220m) is required to meet insurance solvency requirements and which, as a result, is not readily available for the general
purposes of the Group.
14 INTEREST bEARINg loANS ANd boRRoWINgS
Repayment 2008 2007 2006
dates $m $m $m
Current liabilities
Bank overdrafts On demand 163 140 114
Floating Rate Note US dollars 2009 650
Other loans Within one year 180 4,140 22
993 4,280 136
Non-current liabilities
Floating Rate Note US dollars 2009 649
4.625% Non-callable bond Euros 2010 1,053 1,099
5.625% Non-callable bond Euros 2010 702
5.4% Callable bond US dollars 2012 1,823 1,765
5.4% Callable bond US dollars 2014 789 767 756
5.125% Non-callable bond Euros 2015 1,051 1,099
5.9% Callable bond US dollars 2017 1,896 1,768
7% Guaranteed debentures US dollars 2023 324 323 331
5.75% Non-callable bond Pounds sterling 2031 501 691
6.45% Callable bond US dollars 2037 2,716 2,715
10,855 10,876 1,087
All loans and borrowings above are unsecured.
120
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
15 FINANCIAl RISk mANAgEmENT objECTIvES ANd polICIES
The Group’s principal financial instruments, other than derivatives, comprise bank overdrafts, loans, current and non-current investments,
cash and short-term deposits. The main purpose of these financial instruments is to manage the Group’s funding and liquidity requirements.
The Group has other financial assets and liabilities such as trade receivables and trade payables, which arise directly from its operations.
The principal financial risks to which the Group is exposed are those of liquidity, interest rate, foreign currency and credit. Each of these are
managed in accordance with Board-approved policies. These policies are set out below.
The Group uses foreign currency borrowings, foreign currency forwards and options, interest rate swaps and forward rate agreements for
the purpose of hedging its foreign currency and interest rate risks. The Group may designate certain financial instruments as either fair value
hedges or net investment hedges in accordance with IAS 39. Key controls, applied to transactions in derivative financial instruments, are to use
only instruments where good market liquidity exists, to revalue all financial instruments regularly using current market rates and to sell options
only to offset previously purchased options. The Group does not use derivative financial instruments for speculative purposes.
CApITAl mANAgEmENT
The capital structure of the Group consists of shareholders’ equity (Note 20), debt (Note 14) and cash (Note 13). For the foreseeable future,
the Board will maintain a capital structure that supports the Group’s strategic objectives through:
Managing funding and liquidity risk. >
Optimising shareholder return. >
Maintaining a strong investment grade rating. >
Funding and liquidity risk are reviewed regularly by the Board and managed in accordance with policies described below.
The Board’s distribution policy comprises both a regular cash dividend and, subject to business needs, a share re-purchase component.
The Board regularly reviews its shareholders’ return strategy, and in 2008 reaffirmed the dividend policy, which is to grow dividends in line with
reported earnings before restructuring and synergy costs, with an aim to maintain at least two times dividend cover. The Board also initially
stated an intention to re-purchase $1bn of shares in 2008, subject to business needs. Actual re-purchases in 2008 were $610m as the Board
decided in quarter three that no further share re-purchases should take place in 2008 in order to maintain flexibility to invest in the business.
Following the debt financed acquisition of MedImmune in 2007, the Group has been reducing debt and during 2008 has reduced outstanding
debt by $3.3bn to $11.8bn at the end of the year. The Group’s policy is to manage its debt level so as to maintain a strong investment grade
credit rating. The Group’s current long-term credit rating is A1 by Moody’s and AA- by Standard and Poor’s, both with a stable outlook.
lIquIdITy RISk
The Board reviews the Group’s ongoing liquidity risks annually as part of the planning process and on an ad hoc basis. The Board considers
short-term requirements against available sources of funding taking into account cash flow. The Group manages liquidity risk by maintaining
access to a number of sources of funding, which are sufficient to meet anticipated funding requirements. Specifically, the Group uses US
commercial paper, committed bank facilities and cash resources to manage short-term liquidity and manages long-term liquidity by raising
funds through the capital markets.
In addition to cash balances (comprising fixed deposits, cash and cash equivalents less overdrafts) of $4,177m, the Group has committed
bank facilities of $4.3bn available to manage liquidity. As at 31 December 2008, the Group has issued $3,307m under an EMTN programme,
$7,874m under a SEC-registered shelf, $324m under a previous SEC-registered programme and has $163m of commercial paper outstanding.
The Company regularly monitors the credit standing of the banking group and currently does not anticipate any issue with drawing on the
committed facilities should this be necessary. The committed facilities were undrawn as at 31 December 2008.
In 2008, the Group issued a €500m 18 month bond under the EMTN programme to re-finance maturing commercial paper. The $3.35bn five
year committed facilities maturing in October 2012 were increased to $3.6bn and $0.7bn of the $1.8bn 364 day committed facilities, which
matured in October 2008, were renewed for a further 364 day term.
mARkET RISk
Interest rate risk
The Group maintains a mix of fixed and floating rate debt. The portion of fixed rate debt was approved by the Board and any variation requires
Board approval. A significant portion of the long-term debt entered into in 2007 has been held at fixed rates of interest. The Group uses interest
rate swaps and forward rate agreements to manage this mix.
As at 31 December 2008, the Group held interest rate swaps with a notional value of $2.5bn, converting the 5.4% callable bond maturing in
2014, and the 7% guaranteed debentures payable in 2023 to floating rates and partially converting the 5.4% callable bond maturing in 2012
and the 5.9% callable bond maturing in 2017 to floating rates. No new interest rate swaps were entered into during 2008.
The majority of the Group’s cash balances are held with third party fund managers with floating rates of interest being earned.
121
FINANCIAL STATEMENTS
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
15 FINANCIAl RISk mANAgEmENT objECTIvES ANd polICIES CoNTINuEd
Foreign currency risk
The US dollar is the Group’s most significant currency. As a consequence, the Group results are presented in US dollars and exposures are
managed against US dollars accordingly.
Translational
Approximately 57% of Group external sales in 2008 were denominated in currencies other than the US dollar, while a significant proportion
of manufacturing and R&D costs were denominated in sterling and Swedish krona. Surplus cash generated by business units is substantially
converted to, and held centrally in US dollars. As a result, operating profit and total cash flow in US dollars will be affected by movements in
exchange rates.
This currency exposure is managed centrally based on forecast cash flows for the currencies of Swedish krona, sterling, euro, Australian dollar,
Canadian dollar and Japanese yen. The impact of movements in exchange rates is mitigated significantly by the correlations which exist between
the major currencies to which the Group is exposed and the US dollar. Monitoring of currency exposures and correlations is undertaken on a
regular basis and hedging is subject to pre-execution approval.
The Group will maintain debt in non-US dollar currencies to the extent that there is an underlying net investment in the same currency and therefore
a net investment hedge, can be applied. The €500m 2010 bond issued in 2008 was issued in non-US dollar currencies to match investors’ appetite
but currency swaps were transacted to convert it into a fixed rate US dollar instrument. As at 31 December 2008, after currency swaps, 4.2% of
interest bearing loans and borrowings were denominated in sterling and 17.8% of interest bearing loans and borrowings were denominated in euros.
Transactional
The transaction exposures that arise from non-local currency sales and purchases by subsidiaries are, where practicable, fully hedged using
forward foreign exchange contracts. In addition, the Group’s external dividend, which is paid principally in sterling and Swedish krona, is fully
hedged from announcement to payment date.
Credit risk
The Group is exposed to credit risk on financial assets, such as cash balances (including fixed deposits and cash and cash equivalents),
derivative instruments, trade and other receivables. The Group is also exposed in its net asset position to its own credit risk in respect of the
2023 debentures and 2014 bonds which are accounted for at fair value through profit and loss.
During the year, the Company established a credit risk oversight group, consisting of senior members of the finance function to monitor credit
related risks and risk management processes, in response to the ongoing financial markets and economic uncertainty.
Trade and other receivables
Trade receivable exposures are managed locally in the operating units where they arise and credit limits are set as deemed appropriate for the
customer. The Group is exposed to customers ranging from government backed agencies and large private wholesalers to privately owned
pharmacies, and the underlying local economic and sovereign risks vary throughout the world. Where appropriate, the Group endeavours to
minimise risks by the use of trade finance instruments such as letters of credit and insurance. The Group establishes an allowance for impairment
that represents its estimate of incurred losses in respect of specific trade and other receivables where it is deemed that a receivable may not be
recoverable. When the debt is deemed irrecoverable, the allowance account is written off against the underlying receivable.
Other nancial assets
Exposure to financial counterparty credit risk is controlled by the treasury team centrally in establishing and monitoring counterparty limits which
are set according to the assessed risk of each counterparty. Centrally managed funds are invested entirely with counterparties whose credit
rating is ‘A’ or better. During the year, funds held in money market funds have been progressively transferred to US Treasury funds, in light of
the ongoing financial crisis.
External fund managers, who manage $3.0bn of the Group’s cash as at 31 December 2008, are rated AAA by Standard & Poor’s. There were
no other significant concentrations of credit risk at the balance sheet date. All financial derivatives are transacted with commercial banks, in line
with standard market practice and are not backed with cash collateral. The maximum exposure to credit risk is represented by the carrying
amount of each financial asset, including derivative financial instruments recorded, in the balance sheet.
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16 FINANCIAl INSTRumENTS
FAIR vAluES oF FINANCIAl ASSETS ANd FINANCIAl lIAbIlITIES
Set out below is a comparison by category of carrying values and fair values of all the Group’s financial assets and financial liabilities as at
31 December 2008, 31 December 2007 and 31 December 2006. None of the financial assets or financial liabilities have been reclassified
during the year.
Other financial assets represent trade and other receivables (Note 12) excluding prepayments and accrued income. Other financial liabilities
represent trade and other payables (Note 17) and provisions (Note 18) excluding deferred income.
Designated Derivatives and Total
at fair other items at Available Held for Amortised carrying Fair
value fair value for sale trading cost value value
$m $m $m $m $m $m $m
2008
Cash and cash equivalents 4,286 4,286 4,286
Overdrafts (163) (163) (163)
Loans due within one year (830) (830) (830)
Loans due after more than one year (1,113) (1,727) (8,015) (10,855) (11,23 8)
Derivative financial instruments 221 63 284 284
Other investments 156 50 54 260 260
Other financial assets 6,580 6,580 6,580
Other financial liabilities (8,381) (8,381) (8,381)
2007
Cash and cash equivalents 5,867 5,867 5,867
Overdrafts (140) (140) (140)
Loans due within one year (4,140) (4,140) (4,140)
Loans due after more than one year (1,090) (1,544) (8,242) (10,876) (11,235)
Derivative financial instruments 67 19 86 86
Other investments 182 31 60 273 273
Other financial assets 5,973 5,973 5,973
Other financial liabilities (8,070) (8,070) (8,070)
2006
Cash and cash equivalents 7,103 7,103 7,103
Overdrafts (114) (114) (114)
Loans due within one year (22) (22) (22)
Loans due after more than one year (1,087) (1,087) (1,087)
Derivative financial instruments 27 45 72 72
Other investments 37 82 26 559 704 704
Other financial assets 4,794 4,794 4,794
Other financial liabilities (6,729) (6,729) (6,729)
Credit risk increased the fair value of the bonds designated as fair value through profit or loss by $113m for the year and by $134m since
designation. Changes in credit risk had no material effect on any other financial assets and liabilities recognised at fair value in the Financial
Statements. The change in fair value attributable to changes in credit risk is calculated as the change in fair value not attributable to market risk.
The methods and assumptions used to estimate the fair values of financial instruments together with their carrying values are as follows:
Cash and overdrafts – held on the balance sheet at amortised costs. Fair value approximates to carrying value. >
Loans due within one year and after more than one year – the fair value of fixed rate publicly traded debt is based on year end quoted >
market prices; the fair value of floating rate debt is nominal value, as mark to market differences would be minimal given the frequency of
resets. The carrying value of loans designated at fair value through profit or loss is the fair value. For loans designated as other items at fair
value, carrying value is initially measured at fair value and remeasured for fair value changes in respect of the hedged risk at each balance
sheet date. All other loans are held at amortised cost.
Derivative financial instruments – consists of interest rate swaps (included in designated as fair value through profit or loss upon initial recognition or >
as a fair value hedge), forward foreign exchange contracts and foreign currency option contracts (included in derivatives and other items at fair value).
Interest rate swaps – the fair value is estimated using appropriate zero coupon curve valuation techniques based on rates current at year end.
Forward foreign exchange contracts – the majority of contracts for existing transactions had maturity of six months or less from year end.
The fair value of forward foreign exchange contracts is based on market forward foreign exchange rates at the year end.
Foreign currency option contracts – the fair value of option contracts is estimated using Black-Scholes valuation techniques.
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16 FINANCIAl INSTRumENTS CoNTINuEd
Other investments – includes equity securities held on the balance sheet as other investments (Note 10). The fair value of listed investments >
is based on year end quoted market prices. For unlisted investments, carrying values approximate fair value.
Other financial assets and other financial liabilities – held on the balance sheet at amortised costs with carrying value being a reasonable >
approximation of fair value.
The interest rates used to discount future cash flows, where applicable, are based on market swap curves at the reporting date, and were
as follows:
2008 2007 2006
Derivatives 3.8% to 4.6% 4.3% to 5.1% 4.9% to 5.3%
Loans and borrowings 3.8% to 4.6% 4.3% to 5.1% 4.9% to 5.3%
NET gAINS ANd loSSES oN FINANCIAl ASSETS ANd FINANCIAl lIAbIlITIES
2008 2007 2006
$m $m $m
Included in operating profit
(Losses)/gains on forward foreign exchange contracts (399) (59) 168
Gains/(losses) on receivables and payables 391 74 (183)
Losses on investments designated at fair value through profit or loss (1) (13)
(Losses)/gains on available for sale current investments (25) (21) 5
(33) (7) (23)
Included in finance income and expense
Interest and fair value adjustments in respect of debt designated at fair value through profit or loss, net of derivatives 87 (22) (59)
Interest and changes in carrying values of debt designated as hedged items, net of derivatives (64) (28)
Interest and fair value changes on fixed and short-term deposits and equity securities 140 344 368
Interest on debt, overdrafts and commercial paper held at amortised cost (609) (436) (11)
Exchange losses on financial assets and liabilities (12) (3) (14)
(458) (145) 284
$180m fair value gains on hedging instruments and $183m fair value losses on the hedged items have been included within interest and changes
in carrying values of debt designated as hedged items, net of derivatives. $153m fair value gains on hedging instruments and $23m fair value
losses on the hedged items have been included within interest and fair value adjustments in respect of debt designated at fair value through
profit or loss, net of derivatives.
$294m of gains on financial assets and liabilities have been taken directly to equity (2007: losses $70m; 2006: losses $20m).
Ineffectiveness on the net investment hedge taken to the income statement was $nil (2007: $nil; 2006: $nil).
lIquIdITy RISk
The maturity profile of the anticipated future cash flows including interest in relation to the Group’s non-derivative financial liabilities, on an undiscounted
basis and which, therefore, differs from both the carrying value and fair value, is as follows:
Trade, other
Bank overdrafts payables and
and other loans Bonds provisions Total
31 December 2008 $m $m $m $m
Within one year 345 1,271 7,778 9,394
In one to two years 2,335 601 2,936
In two to three years 465 465
In three to four years 2,241 2,241
In four to five years 424 424
In more than five years 12,478 12,478
345 19,214 8,379 27,938
Effect of interest (2) (7,956) (7,958)
Effect of discounting, fair values and issue costs 247 247
31 December 2008 343 11,505 8,379 20,227
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ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
16 FINANCIAl INSTRumENTS CoNTINuEd
Trade, other
Bank overdrafts payables and
and other loans Bonds provisions Total
31 December 2007 $m $m $m $m
Within one year 4,305 619 7,355 12,279
In one to two years 1,259 715 1,974
In two to three years 1,679 1,679
In three to four years 532 532
In four to five years 2,255 2,255
In more than five years 13,356 13,356
4,305 19,700 8,070 32,075
Effect of interest (25) (8,857) (8,882)
Effect of discounting, fair values and issue costs 33 33
31 December 2007 4,280 10,876 8,070 23,226
mARkET RISk
Interest rate risk
The interest rate profile of the Group’s interest bearing financial instruments, as at 31 December 2008, 31 December 2007 and 31 December
2006 are set out below. In the case of non-current financial liabilities, the classification includes the impact of interest rate swaps which convert
the debt to floating rate.
2008 2007 2006
Total Fixed rate Floating rate Total Fixed rate Floating rate Total Fixed rate Floating rate
$m $m $m $m $m $m $m $m $m
Financial liabilities
Interest bearing loans and borrowings
Current 993 993 4,280 4,280 136 136
Non-current 10,855 8,015 2,840 10,876 7,594 3,282 1,087 1,087
11,848 8,015 3,833 15,156 7,594 7,562 1,223 1,223
Financial assets
Fixed deposits 54 54 60 60 559 559
Cash and cash equivalents 4,286 4,286 5,867 5,867 7,103 7,103
4,340 4,340 5,927 5,927 7,662 7,662
In addition to the financial assets above, there are $7,070m (2007: $6,272m; 2006: $5,011m) of other current and non-current asset investments
and other financial assets on which no interest is received.
Foreign currency risk
Translational
During the year there has been a significant movement in exchange rates for the Group’s principal six currency exposures: sterling (GBP),
Swedish krona (SEK), euro (EUR), Australian dollar (AUD), Japanese yen (JPY) and Canadian dollar (CAD). The weakness of our cost currencies
sterling and Swedish krona relative to euro which is our main non-US dollars income currency has resulted in a net benefit for the Group.
No hedges were outstanding as at 31 December 2008.
Transactional
100% of the Group’s major transactional currency exposures on working capital balances, which typically extend for up to three months,
are hedged, where practicable, using forward foreign exchange contracts against individual Group companies’ reporting currency.
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FINANCIAL STATEMENTS
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16 FINANCIAl INSTRumENTS CoNTINuEd
The table below sets out the principal foreign exchange contracts outstanding at 31 December 2008, 31 December 2007 and 31 December
2006 along with the underlying gross exposure as defined above.
GBP SEK EUR AUD JPY CAD
2008 $m $m $m $m $m $m
Gross exposure (676) (444) 505 57 166 49
Forward exchange contracts 690 445 (512) (52) (166) (24)
Net exposure 14 1 (7) 5 25
GBP SEK EUR AUD JPY CAD
2007 $m $m $m $m $m $m
Gross exposure (536) (476) 627 24 168 57
Forward exchange contracts 530 494 (627) (24) (168) (57)
Net exposure (6) 18
GBP SEK EUR AUD JPY CAD
2006 $m $m $m $m $m $m
Gross exposure (429) (697) 625 37 169 61
Forward exchange contracts 653 1,104 (938) (57) (279) (43)
Net exposure 224 407 (313) (20) (110) 18
Sensitivity analysis
The sensitivity analysis set out below summarises the sensitivity of the market value of our financial instruments to hypothetical changes in
market rates and prices. The range of variables chosen for the sensitivity analysis reflects our view of changes which are reasonably possible
over a one year period. Market values are the present value of future cash flows based on market rates and prices at the valuation date.
For long-term debt, an increase in interest rates results in a decline in the fair value of debt.
The sensitivity analysis assumes an instantaneous 100 basis point change in interest rates in all currencies from their levels at 31 December
2008, with all other variables held constant. Based on the composition of our long-term debt portfolio as at 31 December 2008, a 1% increase
in interest rates would result in an additional $38m in interest expense being incurred per year. The exchange rate sensitivity analysis assumes an
instantaneous 10% change in foreign currency exchange rates from their levels at 31 December 2008, with all other variables held constant.
The +10% case assumes a 10% strengthening of the US dollar against all other currencies and the -10% case assumes a 10% weakening
of the US dollar.
Each incremental 10% movement in foreign currency exchange rates would have approximately the same effect as the initial 10% detailed
in the table below.
31 dECEmbER 2008
Interest rates Exchange rates
+1% -1% +10% -10%
Increase/(decrease) in fair value of financial instruments 587 (706) 217 (217)
Impact on income statement: gain/(loss) (57) 57
Impact on equity: gain/(loss) 274 (274)
31 dECEmbER 2007
Interest rates Exchange rates
+1% -1% +10% -10%
Increase/(decrease) in fair value of financial instruments 666 (779) 165 (165)
Impact on income statement: gain/(loss) (37) 37
Impact on equity: gain/(loss) 202 (202)
31 dECEmbER 2006
Interest rates Exchange rates
+1% -1% +10% -10%
Increase/(decrease) in fair value of financial instruments (185) 185
Impact on income statement: gain/(loss) (104) 104
Impact on equity: gain/(loss) (81) 81
There has been no change in the methods and assumptions used in preparing the above sensitivity analysis over the three year period.
126
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16 FINANCIAl INSTRumENTS CoNTINuEd
CREdIT RISk
The carrying amount of financial assets, being cash and cash equivalents, derivative assets, other investments and other financial assets
(consisting of trade and other receivables) represent the maximum credit exposure.
The maximum exposure to credit risk for trade receivables at the reporting date by geographic region was:
2008 2007 2006
$m $m $m
US 2,032 1,961 1,491
United Kingdom 459 425 397
Sweden 226 260 242
Euro-zone countries 833 901 771
Other European countries 257 247 171
Japan 955 771 647
Other countries 796 761 569
5,558 5,326 4,288
In the US, sales to three wholesalers accounted for approximately 81% of US sales (2007: three wholesalers accounted for approximately
82%; 2006: three wholesalers accounted for approximately 80%).
The ageing of trade receivables at the reporting date was:
2008 2007 2006
$m $m $m
Not past due 5,262 4,930 3,966
Overdue but renegotiated 3 120 86
Past due 0-90 days 106 79 83
Past due 90-180 days 60 99 62
Past due > 180 days 127 98 91
5,558 5,326 4,288
2008 2007 2006
$m $m $m
Movements in provisions for trade receivable impairments
Balance at beginning of year 89 52 45
Income statement charge 23 34 4
Amounts utilised, exchange and other movements (13) 3 3
Balance at end of year 99 89 52
The allowance for impairment has been calculated based on past experience and is in relation to specific customers. Given the profile of our
customers, including large wholesalers and government backed agencies, no further credit risk has been identified with the trade receivables
not past due other than those balances for which an allowance has been made.
127
FINANCIAL STATEMENTS
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
17 TRAdE ANd oTHER pAyAblES
2008 2007 2006
$m $m $m
Current liabilities
Trade payables 3,903 3,497 3,482
Value added and payroll taxes and social security 371 434 280
Other payables 1,026 86 5 1,16 6
Accruals 1,878 2,172 1,3 67
7,178 6,968 6,295
Non-current liabilities
Other payables 149 229 254
Included in other payables are amounts totalling $227m (2007: $209m; 2006: $241m) to meet insurance obligations of the Group’s
insurance subsidiaries.
18 pRovISIoNS FoR lIAbIlITIES ANd CHARgES
Employee Other
Severance Environmental benefits provisions Total
$m $m $m $m $m
At 1 January 2006 62 68 122 102 354
Charge/(credit) for year (1) 56 36 (4) 87
On acquisition of subsidiary 20 20
Cash paid (36) (29) (36) (5) (106)
Exchange and other movements 6 (13) 18 11
At 31 December 2006 31 95 109 131 366
Charge for year 620 48 4 58 730
Cash paid (25) (32) (23) (25) (105)
Exchange and other movements 17 10 2 29
At 31 December 2007 643 111 100 166 1,020
Charge/(credit) for year 469 37 (23) 164 647
Cash paid (405) (39) (1) (12) (457)
Exchange and other movements (88) 21 8 (9) (68)
At 31 December 2008 619 130 84 309 1,142
2008 2007 2006
$m $m $m
Due within one year 600 387 39
Due after more than one year 542 633 327
1,142 1,020 366
AstraZeneca is undergoing a worldwide restructuring initiative which involves rationalisation of the Global Supply Chain, European Sales and
Marketing, Information Services and Business Support infrastructure and Research and Development. Employee costs in connection with the
initiatives are recognised in severance provisions. This is a three-year programme expected to be substantially completed by the end of 2010.
Details of the environmental provisions are provided in Note 25.
Employee benefit provisions include the executive deferred bonus plan and other employee benefit provisions. Further details are included in Note 24.
Other provisions comprise various amounts relating to specific legal and constructive obligations and disputes.
No provision has been released or applied for any purpose other than that for which it was established.
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ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
19 CApITAl ANd RESERvES
Share Capital Minority
Share premium redemption Merger Other Retained equity Total
capital account reserve reserve reserves earnings Total interests equity
$m $m $m $m $m $m $m $m $m
At 1 January 2006 395 692 53 433 1,345 10,679 13,597 94 13,691
Total recognised income and expense 6,970 6,970 24 6,994
Transfer to other reserves
1
53 (53)
Dividends (2,217) (2,217) (2,217)
Issue of Ordinary Shares 6 979 985 985
Re-purchase of Ordinary Shares (18) 18 (4,147) (4,147) (4,147)
Share-based payments 129 129 129
Treasury shares (13) (13) (13)
Transfer from minority interests to payables (6) (6)
Net movement (12) 979 18 53 669 1,707 18 1,725
At 31 December 2006 383 1,671 71 433 1,398 11,348 15,304 112 15,416
Total recognised income and expense 5,934 5,934 35 5,969
Transfer to other reserves
1
(20) 20
Dividends (2,658) (2,658) (2,658)
Issue of Ordinary Shares 1 217 218 218
Re-purchase of Ordinary Shares (20) 20 (4,170) (4,170) (4,170)
Share-based payments 150 150 150
Transfer from minority interests to payables (10) (10)
Net movement (19) 217 20 (20) (724) (526) 25 (501)
At 31 December 2007 364 1,888 91 433 1,378 10,624 14,778 137 14,915
Total recognised income and expense 4,176 4,176 48 4,224
Transfer to other reserves
1
27 (27)
Dividends (2,767) (2,767) (2,767)
Issue of Ordinary Shares 1 158 159 159
Re-purchase of Ordinary Shares (3) 3 (610) (610) (610)
Share-based payments 176 176 176
Transfer from minority interests to payables (11) (11)
Dividend paid by subsidiary to minority interest (26) (26)
Net movement (2) 158 3 27 948 1,134 11 1,145
At 31 December 2008 362 2,046 94 433 1,405 11,572 15,912 148 16,060
1
Amounts charged to other reserves relate to exchange adjustments arising on goodwill.
2008 2007 2006
Cumulative translation differences included within retained earnings $m $m $m
Balance at beginning of year 2,414 1,945 1,080
Foreign exchange arising on consolidation (1,355) 489 918
Exchange adjustments on goodwill (recorded against other reserves) (27) 20 (53)
Foreign exchange on borrowings 291 (40)
Net exchange movement in retained earnings (1,091) 469 865
Balance at end of year 1,323 2,414 1,945
oTHER RESERvES
The other reserves arose from the cancellation of £1,255m of share premium account by the parent company in 1993 and the redenomination
of share capital ($157m) in 1999. The reserves are available for writing off goodwill arising on consolidation and, subject to guarantees given to
preserve creditors as at the date of the court order, are available for distribution.
RETAINEd EARNINgS
The cumulative amount of goodwill written off directly to reserves resulting from acquisitions, net of disposals, amounted to $654m (2007: $681m;
2006: $661m) using year end rates of exchange. At 31 December 2008, nil shares, at a cost of $nil, have been deducted from retained
earnings (2007: nil shares, at a cost of $nil; 2006: 1,112,223 shares, at a cost of $40m).
There are no significant statutory or contractual restrictions on the distribution of current profits of subsidiaries, joint ventures or associates;
undistributed profits of prior years are, in the main, permanently employed in the businesses of these companies. The undistributed income of
AstraZeneca companies overseas may be liable to overseas taxes and/or UK taxation (after allowing for double taxation relief) if they were to be
distributed as dividends (see Note 3).
129
FINANCIAL STATEMENTS
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
20 SHARE CApITAl oF pARENT CompANy
Authorised Allotted, called-up and fully paid
2008 2008 2007 2006
$m $m $m $m
Issued Ordinary Shares ($0.25 each) 362 362 364 383
Unissued Ordinary Shares ($0.25 each) 238
Redeemable Preference Shares (£1 each – £50,000)
600 362 364 383
The total authorised number of Ordinary Shares at 31 December 2008 was 2,400,000,000, of which 1,447,481,548 Ordinary Shares were
in issue.
The Redeemable Preference Shares carry limited class voting rights and no dividend rights. This class of shares is capable of redemption at par
at the option of the Company on the giving of seven days’ written notice to the registered holder of the shares.
The movements in the number of shares during the year can be summarised as follows:
No. of shares (million)
2008 2007
At 1 January 1,457 1,532
Issues of shares 4 5
Re-purchase of shares (14) (80)
At 31 December 1,447 1,457
SHARE RE-puRCHASES
During the year the Company re-purchased, and subsequently cancelled, 13,597,940 Ordinary Shares at an average price of 2397 pence per share.
The total consideration, including expenses, was $610m. The consideration has been charged against retained earnings.
SHARE SCHEmES
A total of 4,078,635 Ordinary Shares were issued during the year in respect of share schemes. Details of movements in the number of Ordinary
Shares under option are shown in Note 24; details of options granted to Directors are shown in the Directors’ Remuneration Report.
SHARES HEld by SubSIdIARIES
No shares in the Company were held by subsidiaries in any year.
21 dIvIdENdS To SHAREHoldERS
2008 2007 2006 2008 2007 2006
Per share Per share Per share $m $m $m
Final $1.350 $1.230 $0.920 1,967 1,885 1,453
Interim $0.550 $0.520 $0.490 800 773 764
$1.900 $1.750 $1.410 2,767 2,658 2,217
The second interim dividend, to be confirmed as final, is $1.50 per share and $2,171m in total. This will be payable on 16 March 2009.
On payment of the dividends, exchange gains of $28m (2007: gains of $17m; 2006: losses of $3m) arose. These exchange gains and losses
are included in Note 2.
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22 ACquISITIoNS oF buSINESS opERATIoNS
There were no new acquisitions made during the year ended 31 December 2008.
Details with regard to acquisitions made during the year ended 31 December 2007 are set out below:
mEdImmuNE, INC.
On 1 June 2007, AstraZeneca announced the successful tender offer for all the outstanding shares of common stock of MedImmune, Inc.,
a world-leading biotechnology company with proven biologics discovery and development strength, pipeline and leading biomanufacturing
capability. At that date, approximately 96.0% of the outstanding shares were successfully tendered; the remaining shares were acquired by
18 June 2007. The financial results of MedImmune, Inc. have been consolidated into the Group’s results from 1 June 2007.
Cash consideration of $13.9bn was paid for the outstanding shares. After taking account of the cash and investments acquired, together with
the settlement of MedImmune’s convertible debt and outstanding share options, the total cash paid to acquire MedImmune was $15.6bn.
In most business acquisitions, there is a part of the cost that is not capable of being attributed in accounting terms to identifiable assets and
liabilities acquired and is therefore recognised as goodwill. In the case of the acquisition of MedImmune, this goodwill is underpinned by a
number of elements, which individually cannot be quantified. Most significant amongst these is the premium attributable to a pre-existing,
well positioned business in the innovation intensive, high growth biologics market with a highly skilled workforce and established reputation.
Other important elements include buyer specific synergies, potential additional indications for identified products and the core technological
capabilities and knowledge base of the company.
MedImmune, Inc. contributed $714m of turnover in the year of acquisition. After amortisation, net investments/interest costs (including interest
costs of external financing of $446m) and tax, the loss attributable to MedImmune in the year of acquisition was $410m. If the acquisition had
taken effect at the beginning of the reporting period (1 January 2007), on a proforma basis the revenue, profit before tax and profit after tax of
the combined Group for 2007 would have been $30,127m, $7,576m and $5,351m, respectively. Basic and diluted Earnings per Share for the
combined Group in 2007 would have been $3.56 and $3.55, respectively. This proforma information has been prepared taking into account
amortisation, interest costs and related tax effects but does not purport to represent the results of the combined Group that actually would
have occurred had the acquisition taken place on 1 January 2007 and should not be taken to be representative of future results.
Fair value
Book value adjustment Fair value
$m $m $m
Non-current assets
Intangible assets 193 7,882 8,075
Property, plant and equipment 523 70 593
Other 550 (17) 533
1,266 7,935 9,201
Current assets 1,439 115 1,554
Current liabilities (326) 39 (287)
Additional obligations related to convertible debt and share options (1,724) (1,724)
Non-current liabilities
Interest bearing loans and borrowings (1,165) (1,165)
Other payables (73) (73)
Deferred tax assets/(liabilities) 314 (2,694) (2,380)
(924) (2,694) (3,618)
Total assets acquired 1,455 3,671 5,126
Goodwill 8,757
Total consideration for outstanding shares 13,883
Additional payments related to convertible debt, share options and other acquisition obligations 1,770
Total consideration 15,653
The total consideration for outstanding shares includes $29m of directly attributable costs.
The intangible assets acquired included: (a) product, marketing and distribution rights relating to currently marketed products or franchises
(principally in respect of the Synagis and motavizumab RSV franchise, FluMist and Ethyol); (b) product marketing and distribution rights relating
to products in development (principally motavizumab); and distribution rights relating to out-licensed product (principally the HPV cervical
cancer vaccine). The combined acquisitions fair value of $8,075m comprised $6,570m relating to the Infection Therapy Area, $1,425m relating
to the Oncology Therapy Area and $80m relating to the R&I Therapy Area. The carrying value of these assets is summarised in Note 9.
131
FINANCIAL STATEMENTS
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22 ACquISITIoNS oF buSINESS opERATIoNS CoNTINuEd
oTHER ACquISITIoNS
Fair value
Book value adjustment Fair value
$m $m $m
Non-current assets
Intangible assets 347 347
Property, plant and equipment 7 7
7 347 354
Current assets 12 12
Current liabilities (19) (19)
Non-current liabilities
Other payables (9) (9)
Deferred tax liabilities (118) (118)
(9) (118) (127)
Total assets acquired (9) 229 220
Goodwill
Total consideration 220
The total consideration includes $3m of directly attributable costs.
Arrow Therapeutics Limited
On 28 February 2007, the Company acquired 100% of the issued share capital of Arrow Therapeutics Limited for cash consideration of
$147m. Arrow Therapeutics Limited is a UK biotechnology company, focused on the discovery and development of anti-viral therapies.
The acquisition provides a widely recognised expert group and technology platform in an area of research that complements internal
capabilities in the therapy area of infection and anti-bacterials.
Arrow Therapeutics Limited had revenue of $nil and a loss of $26m for 2007 of which $nil of revenue and $17m of loss related to the period
between acquisition and 31 December 2007.
Atlantis Components Inc.
On 10 October 2007, a Company subsidiary, Astra Tech, acquired 100% of the issued share capital of Atlantis Components Inc. for cash
consideration of $71m.
Atlantis Components Inc. is a US dental business whose principal activity is the design and manufacture of bespoke dental implant abutments.
The intangible asset acquired is the specialist CAD/CAM technology used to design and manufacture customised dental implant abutments.
The acquisition further strengthens Astra Tech’s product portfolio in the field of dental implants.
The revenue and loss in 2007, for both the period since acquisition and full year, are immaterial.
CASH FloWS
MedImmune, Inc. Other Total
$m $m $m
Total consideration 15,653 220 15,873
Cash and cash equivalents included in undertaking acquired (979) (3) (982)
Net cash consideration 14,674 217 14,891
Details with regard to acquisitions made during the year ended 31 December 2006 are set out below:
Cambridge Antibody Technology Group plc
On 22 August 2006, AstraZeneca completed the acquisition of 100% of the issued share capital of Cambridge Antibody Technology Group
plc, a biopharmaceutical company with a leading position in the discovery and development of human therapeutic antibodies. On 22 June
2006, the offer to acquire the entire share capital of Cambridge Antibody Technology Group plc was declared unconditional and the financial
results of Cambridge Antibody Technology Group plc were consolidated into the Company’s results from this date. Cash consideration of
$1,074m was paid during 2006. Prior to the acquisition, AstraZeneca had been engaged in a collaboration and licensing agreement with
Cambridge Antibody Technology Group plc. At 31 December 2005, AstraZeneca held a 19.2% interest in the issued share capital of
Cambridge Antibody Technology Group plc, which was recorded on the balance sheet within non-current asset investments as ‘Equity
securities available for sale’.
The goodwill arising on the acquisition results from assets which cannot be recognised separately and measured reliably including early stage
pipeline products and a highly skilled workforce.
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22 ACquISITIoNS oF buSINESS opERATIoNS CoNTINuEd
Cambridge Antibody Technology Group plc had revenue of $nil and a loss of $58m for 2006, of which $nil of revenue and $38m of loss related
to the period between acquisition and 31 December 2006. Subsequent to the acquisition of Cambridge Antibody Technology Group plc, the
Humira
royalty stream acquired with the company was sold for $661m.
Fair value
Book value adjustment Fair value
$m $m $m
Non-current assets
Intangible assets – Humira
royalty stream 675 675
Intangible assets – other 21 560 581
Property, plant and equipment 24 24
Other 20 20
65 1,235 1,300
Current assets 336 336
Current liabilities (72) (72)
Non-current liabilities
Deferred taxation (5) (364) (369)
Other (20) (20)
(5) (384) (389)
Total assets acquired 324 851 1,175
Goodwill 104 104
Less:
Existing non-current asset investment (163) (163)
Total consideration 324 792 1,116
Exchange (24) (24)
Settled in loan notes (18) (18)
Cash paid 324 750 1,074
The total consideration includes $15m of directly attributable costs.
KuDOS Pharmaceuticals Limited
On 31 January 2006, the Company acquired 100% of the issued share capital of KuDOS Pharmaceuticals Limited for a cash consideration of
$206m. KuDOS Pharmaceuticals Limited is a UK biotechnology company focused on the discovery and development of oncology therapies
based on inhibition of DNA repair. The acquisition provides the Company with a widely recognised expert group and technology platform
that complements the existing capabilities of the oncology franchise, one of the Company’s key therapy areas. The goodwill arising on the
acquisition results from assets which cannot be recognised separately and measured reliably and includes early stage pipeline products.
KuDOS Pharmaceuticals Limited had revenue of $nil and a loss of $15m for 2006 of which $nil of revenue and $14m of loss related to the
period between acquisition and 31 December 2006.
Fair value
Book value adjustment Fair value
$m $m $m
Non-current assets
Intangible assets – other 285 285
Property, plant and equipment 2 2
2 285 287
Current assets 3 3
Current liabilities (11) (11)
Non-current liabilities
Deferred taxation (85) (85)
Total assets acquired (6) 200 194
Goodwill 12 12
Total consideration (6) 212 206
The total consideration includes $2m of directly attributable costs.
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CASH FloWS
Cambridge
Antibody KuDOS
Technology Pharmaceuticals
Group plc Limited Total
$m $m $m
Total consideration 1,074 206 1,280
Cash and cash equivalents included in undertaking acquired (129) (3) (132)
Net cash consideration 945 203 1,148
23 poST-RETIREmENT bENEFITS
pENSIoNS
Background
The Company and most of its subsidiaries offer retirement plans which cover the majority of employees in the Group. Many of these plans are
“defined contribution”, where the company contribution and resulting income statement charge is fixed at a set level or is a set percentage of
employees’ pay. However, several plans, mainly in the UK, the US and Sweden, are “defined benefit”, where benefits are based on employees’
length of service and average final salary (typically averaged over 1, 3 or 5 years). The major defined benefit plans, apart from the collectively
bargained Swedish plan (which is still open to employees born before 1979), have been closed to new entrants since 2000.
The UK plan, which is the single largest plan, has specific restrictions imposed on one section of the membership preventing amendments
that will prejudice the rights or interest of that section of the membership.
The major defined benefit plans are funded through legally separate fiduciary administered funds. The cash funding of the plans, which may
from time to time involve special payments, is designed, in consultation with independent qualified actuaries, to ensure that the assets together
with future contributions should be sufficient to meet future obligations. The funding is monitored rigorously by the Company and appropriate
fiduciaries specifically with reference to the Company’s credit rating, market capitalisation and cash flows.
Post-retirement scheme deficit
The assets and obligations of the defined benefit schemes operated by the Group at 31 December 2008 as calculated in accordance with IAS 19
are shown below. The fair values of the schemes’ assets are not intended to be realised in the short term and may be subject to significant change
before they are realised. The present value of the schemes’ obligations is derived from cash flow projections over long periods and is thus
inherently uncertain.
Value at 31 December 2008 Value at 31 December 2007
UK Rest of Group Total UK Rest of Group Total
$m $m $m $m $m $m
Scheme assets
Equities 1,461 960 2,421 2,581 1,453 4,034
Bonds 1,935 772 2,707 2,517 888 3,405
Others 439 281 720 1,212 303 1,515
Total fair value of assets 3,835 2,013 5,848 6,310 2,644 8,954
Present value of scheme obligations (5,029) (3,591) (8,620) (7,644) (3,348) (10,992)
Past service cost not yet recognised 40 40 40 40
Deficit in the scheme as recognised in the balance sheet (1,194) (1,538) (2,732) (1,334) (664) (1,998)
During the year, the Group has adopted IFRIC 14 ‘IAS19 – The Limit on a Defined Benefit Asset, Minimum Funding Requirements and their
Interaction’. There are no impacts on the reported results.
Financing Principles
96.3% of the Group’s defined benefit obligations at 31 December 2008 are in schemes within the UK, the US, Sweden or Germany. In these
countries the pension obligations are funded with reference to the following financing principles:
The Group has a fundamental belief in funding the benefits it promises to employees. >
The Group considers its pension arrangements in the context of its broader capital structure. In general it does not believe in committing >
excessive capital for funding whilst it has better uses of capital within the business nor does it wish to generate surpluses.
The pension funds are not part of the Group’s core business. Pension funds may take rewarded risks with the investments underlying the >
funding, subject to adequate controls and the expected rewards outweighing the risks.
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23 poST-RETIREmENT bENEFITS CoNTINuEd
The Group recognises that deciding to hold certain investments may cause volatility in the funding position. The Group would not wish to >
amend its contribution level for relatively small deviations from its preferred funding level, because it is expected that there will be short term
volatility, but it is prepared to react appropriately to more significant deviations.
In the event that local regulations require an additional level of financing, the Group would consider the use of alternative methods of providing >
this that do not require immediate cash funding but help mitigate exposure of the pension arrangement to the credit risk of the Group.
These principles are appropriate to AstraZeneca’s business at the present date; should circumstances change they may require review.
The Company has developed a funding framework to implement these principles. This determines the cash contributions payable to the
pension funds, but does not affect the IAS 19 liabilities. To reduce the risk of committing excess capital to pension funds, liabilities are based
on the expected return on the actual pension assets, rather than a corporate bond yield. At present this puts a different value on the liabilities
than IAS 19.
UK
With regard to the Group’s UK defined benefit fund, the above principles are modified in light of the UK regulatory requirements and resulting
discussions with the pension fund Trustee. The most recent full actuarial valuation was carried out at 31 March 2006.
Under the agreed funding principles for the UK, cash contributions will be paid to the fund to target a level of assets in excess of the current
expected cost of providing benefits. The Company will make additional contributions to an escrow account which will be held outside of the
pension fund. The escrow account assets will be payable to the fund in agreed circumstances, for example in the event of the Company and
Trustee agreeing a change to the current long term investment strategy.
The market value of the fund’s assets at the valuation date was £3,070m ($5,363m equivalent), representing 97% of the fund’s actuarially
assessed liabilities as valued in accordance with the fund’s technical provisions. The shortfall will be funded over nine years through payments
of about £62m per annum which include the regular contributions required to meet the benefits accruing of about £53m per annum. In addition
to this, contributions of around £27m per annum will be payable to the escrow account.
Under the agreed funding principles, the key assumptions as at 31 March 2006 for contributions to both the fund and escrow account are as
follows: long-term UK price inflation set at 2.8% pa, salary increases at 4.1% pa, pension increases at 2.8% pa and investment returns at
6.8% pa (pre-retirement) and 5.1% pa (post-retirement).
Rest of Group
The IAS 19 positions as at 31 December 2008 are shown below for each of the other countries with significant defined benefit plans. These
plans account for 91% of the Group’s defined benefit obligations outside of the UK. In principle, these plans are funded in line with the financing
principles and contributions paid as prescribed by the funding framework.
The US defined benefits programme was actuarially revalued at 31 December 2008, when plan obligations were $1,724m and plan assets >
were $1,150m. This includes obligations in respect of the non-qualified plan which is largely unfunded.
The Swedish defined benefits programme was actuarially revalued at 31 December 2008, when plan obligations were estimated to amount >
to $1,349m and plan assets were $576m.
The German defined benefits programme was actuarially revalued at 31 December 2008, when plan obligations amounted to $198m and >
plan assets were $27m.
On current bases, it is expected that contributions (excluding those in respect of past service cost) during the year ended 31 December 2009
to the four main countries will be $230m. However, the Company and the Trustees are currently in discussions to increase contributions.
poST-RETIREmENT bENEFITS oThER ThAN pENSIoNS
In the US, and to a lesser extent in certain other countries, AstraZeneca’s employment practices include the provision of healthcare and life
assurance benefits for retired employees. As at 31 December 2008, some 4,377 retired employees and covered dependants currently benefit
from those provisions and some 13,771 current employees will be eligible on their retirement. AstraZeneca accrues for the present value of
such retiree obligations over the working life of the employee. In practice these benefits will be funded with reference to the Financing Principles.
The cost of post-retirement benefits other than pensions for the Group in 2008 was $21m (2007: $26m; 2006: $12m). Plan assets were $197m
and plan obligations were $428m at 31 December 2008. These benefit plans have been included in the disclosure of post-retirement benefits
under IAS 19.
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23 poST-RETIREmENT bENEFITS CoNTINuEd
FINANCIAl ASSumpTIoNS
Qualified independent actuaries have updated the actuarial valuations of the major defined benefit schemes operated by the Group to
31 December 2008. The assumptions used by the actuaries are chosen from a range of possible actuarial assumptions which, due to the
long-term nature of the scheme, may not necessarily be borne out in practice. These assumptions were as follows:
2008 2007
UK Rest of Group UK Rest of Group
Inflation assumption 2.8% 2.2% 3.3% 2.3%
Rate of increase in salaries 3.8% 3.4% 4.5% 3.7%
Rate of increase in pensions in payment 2.8% 0.8% 3.3% 0.9%
Discount rate 6.2% 4.6% 5.8% 5.4%
Long term rate of return expected at 31 December
Equities 7.9% 7.7% 8.0% 8.9%
Bonds 5.2% 4.9% 5.6% 5.0%
Others 6.0% 3.5% 6.5% 4.8%
Rate of increase in medical costs 10.0% 10.0% 10.0% 9.0%
The expected return on assets is determined with reference to the expected long term level of dividends, interest and other returns derived
from the plan assets, together with realised and unrealised gains or losses on the plan assets, less any costs of administering the plan, less any
tax payable by the plan. The expected returns are based on long term market expectations and analysed on a regular basis to ensure any
sustained movements in underlying markets are reflected.
dEmogRAphIC ASSumpTIoNS
The mortality assumptions are based on country specific mortality tables. These are compared to actual AstraZeneca experience and adjusted
where sufficient data is available. Additional allowance for future improvements in life expectancy is included for all major schemes where there
is credible data to support this continuing trend.
The table below illustrates life expectancy assumptions at age 65 for male members retiring in 2008 and members expected to retire in 2028.
Life expectancy assumption for a male member retiring at age 65
Country 2008 2028 2007 2027
UK 23.8 25.8 23.7 25.7
US 19.6 21.1 19.6 21.1
Sweden 20.4 22.4 20.4 22.4
Germany 17.7 20.5 17.7 20.5
SENSITIvITy oF mEdICAl CoST ASSumpTIoNS
Effect of change in medical cost assumption increase/(decrease)
2008 2007
+1% –1% +1% –1%
Current service and interest cost of net periodic post-employment medical costs ($m) 4 (3) 4 (4)
Accumulated post-employment benefit obligation for medical costs ($m) 28 (28) 30 (19)
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23 poST-RETIREmENT bENEFITS CoNTINuEd
ACTuARIAl gAINS ANd loSSES
2008 2007 2006 2005
UK
Present value of obligations ($m) (5,029) (7,644) (7,352) (6,309)
Fair value of plan assets ($m) 3,835 6,310 6,078 5,314
Deficit in the scheme ($m) (1,194) (1,334) (1,274) (995)
Experience adjustments on:
Scheme assets
Amount ($m) (1,185) (185) (259) 636
Percentage of scheme assets 30.9% 2.9% 4.3% 12.0%
Scheme obligations
Amount ($m) 972 114 71 (539)
Percentage of scheme obligations 19.3% 1.5% 1.0% 8.5%
Rest of Group
Present value of obligations ($m) (3,591) (3,348) (3,109) (2,995)
Fair value of plan assets ($m) 2,013 2,644 2,493 2,284
Deficit in the scheme ($m) (1,578) (704) (616) (711)
Experience adjustments on:
Scheme assets
Amount ($m) (700) (24) 55 63
Percentage of scheme assets 34.8% 0.9% 2.2% 2.8%
Scheme obligations
Amount ($m) (319) (18) 25 (195)
Percentage of scheme obligations 8.9% 0.5% 0.8% 6.5%
Total
Present value of obligations ($m) (8,620) (10,992) (10,461) (9,304)
Fair value of plan assets ($m) 5,848 8,954 8,571 7,598
Deficit in the scheme ($m) (2,772) (2,038) (1,890) (1,706)
Experience adjustments on:
Scheme assets
Amount ($m) (1,885) (209) (204) 699
Percentage of scheme assets 32.2% 2.3% 2.4% 9.2%
Scheme obligations
Amount ($m) 653 96 96 (734)
Percentage of scheme obligations 7.6% 0.9% 0.9% 7.9%
The obligation arises from the following plans:
2008 2007
UK Rest of Group UK Rest of Group
$m $m $m $m
Funded (5,004) (3,025) (7, 616 ) (2, 911)
Unfunded (25) (566) (28) (437)
Total (5,029) (3,591) ( 7,6 4 4) ( 3,3 4 8)
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FINANCIAL STATEMENTS
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23 poST-RETIREmENT bENEFITS CoNTINuEd
INComE STATEmENT dISCloSuRES
The amounts that have been charged to the consolidated income statement and consolidated statement of recognised income and expense,
in respect of defined benefit schemes for the year ended 31 December 2008 are set out below:
2008 2007
UK Rest of Group Total UK Rest of Group Total
$m $m $m $m $m $m
Operating profit
Current service cost (146) (107) (253) (187) (113) (300)
Past service cost (86) (28) (114) (38) (6) (44)
Settlements and curtailments 19 28 47
Total charge to operating profit (213) (107) (320) (225) (119) (344)
Finance expense
Expected return on post-retirement scheme assets 398 187 585 402 171 573
Interest on post-retirement scheme obligations (416) (172) (588) (379) (160) (539)
Net return (18) 15 (3) 23 11 34
Charge before taxation (231) (92) (323) (202) (108) (310)
Consolidated statement of recognised income and expense
Difference between the actual return and the expected
return on the post-retirement schemes’ assets (1,185) (700) (1,885) (185) (24) (209)
Experience gains/(losses) arising on
the post-retirement schemes’ obligations 78 4 82 (359) (62) (421)
Changes in assumptions underlying the present
value of the post-retirement schemes’ obligations 894 (323) 571 473 44 517
Actuarial losses recognised (213) (1,019) (1,232) (71) (42) (113)
movEmENT IN poST-RETIREmENT SChEmE oblIgATIoNS
2008 2007
UK Rest of Group Total UK Rest of Group Total
$m $m $m $m $m $m
Present value of obligation in schemes at beginning of year (7,644) (3,348) (10,992) (7,352) (3,109) (10,461)
Current service cost (146) (107) (253) (187) (113) (300)
Past service cost (86) (28) (114) (38) (6) (44)
Participant contributions (43) (3) (46) (29) (2) (31)
Benefits paid 375 112 487 311 99 410
Other finance expense (416) (172) (588) (379) (160) (539)
Expenses 8 8 9 9
Actuarial gain/(loss) 972 (319) 653 114 (18) 96
Settlements and curtailments 19 28 47
Exchange 1,932 246 2,178 (93) (39) (132)
Present value of obligations in schemes at end of year (5,029) (3,591) (8,620) (7,644) (3,348) (10,992)
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23 poST-RETIREmENT bENEFITS CoNTINuEd
FAIR vAluE oF SChEmE ASSETS
2008 2007
UK Rest of Group Total UK Rest of Group Total
$m $m $m $m $m $m
At beginning of year 6,310 2,644 8,954 6,078 2,493 8,571
Expected return on plan assets 398 187 585 402 171 573
Expenses (8) (8) (9) (9)
Actuarial losses (1,185) (700) (1,885) (185) (24) (209)
Exchange (1,583) (161) (1,744) 90 2 92
Employer contributions 235 152 387 216 99 315
Participant contributions 43 3 46 29 2 31
Benefits paid (375) (112) (487) (311) (99) (410)
At end of year 3,835 2,013 5,848 6,310 2,644 8,954
The actual return on the plan assets was a loss of $1,300m (2007: gain of $364m; 2006: gain of $314m).
Included in total assets and obligations for the UK scheme is $235m in respect of members’ defined contribution sections. Costs in respect of
defined contribution schemes during the year were $130m (2007: $105m; 2006: $62m).
TRANSACTIoNS wITh pENSIoN SChEmES
During the year, the Group made loans to UK and Sweden pension schemes to help them manage their short term liquidity requirements.
The maximum balance outstanding in the year was $220m and the amount outstanding at 31 December 2008 was $2m.
RESERvES
Included within the retained earnings reserve is the actuarial reserve. Movements on this reserve are as follows:
2008 2007 2006
$m $m $m
At 1 January (479) (401) (328)
Actuarial losses (1,232) (113) (108)
Deferred tax 340 35 35
At 31 December (1,371) (479) (401)
The cumulative amount of actuarial losses before deferred tax recognised in the statement of recognised income and expense is $1,867m
(2007: $635m; 2006: $522m).
24 EmployEE CoSTS ANd ShARE opTIoN plANS FoR EmployEES
EmployEE CoSTS
The average number of people, to the nearest hundred people, employed by the Group is set out in the table below. In accordance with the
Companies Act 1985, this includes part-time employees:
Employees 2008 2007 2006
Average number of people employed by the Group in:
UK 11,000 11,8 0 0 11,8 00
Continental Europe 23,100 25,600 26,600
The Americas 20,900 20,200 18,200
Asia, Africa & Australasia 11,100 10,300 10,000
Continuing operations 66,100 67,900 66,600
The number of people employed by the Group at the end of 2008 was 65,000 (2007: 67,400; 2006: 66,800).
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FINANCIAL STATEMENTS
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24 EmployEE CoSTS ANd ShARE opTIoN plANS FoR EmployEES CoNTINuEd
The costs incurred during the year in respect of these employees were:
2008 2007 2006
$m $m $m
Salaries 5,080 5,217 4,580
Social security costs 743 858 832
Pension costs 497 449 390
Other employment costs 596 584 553
6,916 7,10 8 6 ,3 5 5
Severance costs of $546m are not included above (2007: $724m; 2006: $66m).
The Directors believe that, together with the basic salary system, the Group’s employee incentive schemes provide competitive and market-
related packages to motivate employees. They should also align the interests of employees with those of shareholders, as a whole, through
long-term share ownership in the Company. The Group’s current UK, Swedish and US schemes are described below; other arrangements
apply elsewhere.
boNuS plANS
The AstraZeneca UK Performance Bonus Plan
Employees of participating AstraZeneca UK companies are invited to participate in this bonus plan, which rewards strong individual performance.
Bonuses are paid partly in the form of Ordinary Shares in the Company (under the Inland Revenue-approved AstraZeneca All-Employee Share
Plan and up to a maximum annual value of £3,000) and partly in cash. A tax-efficient share retention scheme, under which employees leave
their bonus shares in trust for three to five years, forms part of the All-Employee Share Plan. The Company also offers UK employees the
opportunity to buy Partnership Shares (Ordinary Shares) under the All-Employee Share Plan. Employees may invest up to £1,500 over a 12
month accumulation period and purchase Partnership Shares in the Company with the total proceeds at the end of the period. The purchase
price for the shares is the lower of the price at the beginning or the end of the 12 month period. A tax-efficient share retention scheme is also
available in respect of Partnership Shares. At the Company’s AGM in 2002, shareholders approved the issue of new shares for the purposes of
the All-Employee Share Plan.
The AstraZeneca Executive Annual Bonus Scheme
This scheme is a performance bonus scheme for Directors and senior employees who do not participate in the AstraZeneca UK Performance
Bonus Plan. Annual bonuses are paid in cash and reflect both corporate and individual performance measures. The Remuneration Committee
has discretion to reduce or withhold bonuses if business performance falls sufficiently short of expectations in any year such as to make the
payment of bonuses inappropriate.
The AstraZeneca Deferred Bonus Plan
This plan was introduced in 2006 and is used to defer a portion of the bonus earned under the AstraZeneca Executive Annual Bonus Scheme
into Ordinary Shares in the Company for a period of three years. The plan currently operates only in respect of Executive Directors and
members of the Senior Executive Team (SET). Awards of shares under this plan are typically made in February each year, the first award having
been made in February 2006.
The AstraZeneca Performance Share Plan
This plan was approved by shareholders in 2005 for a period of 10 years. Generally, awards can be granted at any time, but not during a
close period of the Company. The first grant of awards was made in June 2005. The main grant of awards in 2008 under the plan was in
March, at the same time as options were granted under the AstraZeneca Share Option Plan, with a further smaller grant in August. Awards
granted under the plan vest after three years subject to a performance condition. For all participants except employees of MedImmune, the
performance condition relates to the performance of the Company’s total shareholder return compared to that of a selected peer group of
other pharmaceutical companies. A separate performance condition applies to employees of MedImmune linked to the achievement of
MedImmune business targets. The Remuneration Committee has responsibility for agreeing any awards under the plan and for setting the
policy for the way in which the plan should be operated, including agreeing performance targets and which employees should be invited to
participate. A fuller description of this plan can be found on page 179 in the Directors’ Remuneration Report.
The AstraZeneca Pharmaceuticals LP Executive Performance Share Plan
This plan was introduced in 2007 and is used to grant awards of performance shares to selected US employees under broadly the same
terms as awards are made under the AstraZeneca Performance Share Plan. The main grant of awards in 2008 under the plan was in March,
with a further smaller grant in August. Awards granted under the plan vest after three years subject to a performance condition. As with the
AstraZeneca Performance Share Plan, for all participants except employees of MedImmune, the performance condition relates to the
performance of the Company’s total shareholder return compared to that of a selected peer group of other pharmaceutical companies.
A separate performance condition applies to employees of MedImmune linked to the achievement of MedImmune business targets. The
Remuneration Committee has responsibility for agreeing any awards under the plan and for setting the policy for the way in which the plan
should be operated, including agreeing performance targets and which employees should be invited to participate.
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24 EmployEE CoSTS ANd ShARE opTIoN plANS FoR EmployEES CoNTINuEd
The AstraZeneca Pharmaceuticals LP Restricted Stock Unit Award Plan
This plan was introduced in 2007 and provides for the grant of restricted stock unit (RSU) awards to selected employees (predominantly in the
US). The RSU Plan is used in conjunction with the AstraZeneca Share Option Plan to provide a mix of restricted stock units and share options.
The main grant of awards in 2008 under the plan was in March, with a further smaller grant in August. Awards typically vest on the third
anniversary of the date of grant and are contingent on continued employment with the Company. The Remuneration Committee has
responsibility for agreeing any awards under the plan and for setting the policy for the way in which the plan should be operated.
The MedImmune, Inc. 2008 Restricted Stock Unit Award Plan
This plan was introduced in 2008 and provides for the grant of restricted stock unit awards to selected employees of MedImmune. This plan is
used in conjunction with the AstraZeneca Share Option Plan to provide a mix of restricted stock units and share options. The grant of awards
in 2008 under the plan was in March. Awards typically vest on the third anniversary of the date of grant and are contingent on continued
employment with the Company. The Remuneration Committee has responsibility for agreeing any awards under the plan and for setting the
policy for the way in which the plan should be operated.
The AstraZeneca Restricted Share Plan
This plan was introduced in 2008 and provides for the grant of restricted share awards to key employees, excluding Executive Directors. Awards are
made on an ad hoc basis with variable vesting dates. The plan has been used twice in 2008 to make awards to four employees. The Remuneration
Committee has responsibility for agreeing any awards under the plan and for setting the policy for the way in which the plan should be operated.
Sweden
In Sweden an all-employee performance bonus plan is in operation, which rewards strong individual performance. Bonuses are paid partly into
a fund investing 50% in AstraZeneca equities and partly in cash. The AstraZeneca Executive Annual Bonus Scheme, the AstraZeneca Share
Option Plan and the AstraZeneca Performance Share Plan all operate in respect of relevant AstraZeneca employees in Sweden.
US
In the US, there are two all-employee performance bonus plans in operation, which reward strong individual performance. Annual bonuses are
paid in cash. There are also two senior staff incentive schemes, under which approximately 470 participants may be eligible for awards granted
as either AstraZeneca ADSs or stock appreciation rights related to AstraZeneca ADSs. AstraZeneca ADSs necessary to satisfy the awards are
purchased in the market. The AstraZeneca Share Option Plan, the AstraZeneca Pharmaceuticals LP Executive Performance Share Plan, the
AstraZeneca Pharmaceuticals LP Restricted Stock Unit Award Plan, and the MedImmune, Inc. 2008 Restricted Stock Unit Award Plan operate
in respect of relevant employees in the US.
ASTRAZENECA pERFoRmANCE ShARE plAN
Shares WAFV
1
’000 pence
Shares awarded in June 2005 312 1121
Shares awarded in March 2006 280 1486
Shares awarded in May 2006 19 1424
Shares awarded in March 2007 1,611 1372
Shares awarded in August 2007 68 1217
Shares awarded in November 2007 16 1105
Shares awarded in March 2008 1,338 941
Shares awarded in August 2008 14 1326
ASTRAZENECA phARmACEuTICAlS lp RESTRICTEd SToCk uNIT AwARd plAN
Units WAFV
1
000 $
Units awarded in March 2007 755 26.90
Units awarded in November 2007 270 21.56
Units awarded in March 2008 1,313 18.88
1
Weighted average fair value.
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24 EmployEE CoSTS ANd ShARE opTIoN plANS FoR EmployEES CoNTINuEd
ASTRAZENECA phARmACEuTICAlS lp ExECuTIvE pERFoRmANCE ShARE plAN
Shares WAFV
1
000 $
Shares awarded in March 2007 38 25.86
Shares awarded in March 2008 2,094 18.88
Shares awarded in August 2008 20 24.46
mEdImmuNE, INC. 2008 RESTRICTEd SToCk uNIT AwARd plAN
Units WAFV
1
000 $
Units awarded in March 2008 130 18.88
ASTRAZENECA RESTRICTEd ShARE plAN
Shares WAFV
1
’000 pence
Shares awarded in March 2008 51 941
Shares awarded in May 2008 35 2210
1
Weighted average fair value.
The fair values were determined using a modified version of the binomial model. This method incorporated expected dividends but no other
features into the measurements of fair value.
The charge for share-based payments in respect of the AstraZeneca Performance Share Plan, the US incentive share schemes and restricted
stock unit award plan is $53m (2007: $31m; 2006: $14m). The plans are equity-settled.
ShARE opTIoN plANS
At 31 December 2008, there were options outstanding under the Zeneca 1994 Executive Share Option Scheme, the AstraZeneca Savings-
Related Share Option Scheme, the AstraZeneca Savings-Related Share Option Plan and the AstraZeneca Share Option Plan.
(1) SummARy oF ThE ASTRAZENECA ShARE opTIoN plAN
This is a share option plan for employees of participating AstraZeneca Group companies which was approved by shareholders at the
Company’s AGM in 2000. The first grant of options occurred in August 2000. The main grant of options in 2008 under the plan was in March,
with a further smaller grant in August. The Remuneration Committee sets the policy for the Company’s operation of the plan and, in
accordance with the rules of the plan, conducted a review of the plan in 2004.
Eligibility
Any AstraZeneca employee may be recommended from time to time for the grant of an option. The Remuneration Committee sets the policy
for the Company’s operation of the plan including as regards which employees will be eligible to participate.
Grant of options
Options may be granted at any time other than during a close period. The grant of options is supervised by the Remuneration Committee,
which is comprised wholly of Non-Executive Directors. No payment is required for the grant of an option. Options are not transferable. Options
may be granted over AstraZeneca Ordinary Shares or ADSs.
Acquisition price
The price per Ordinary Share payable upon the exercise of an option will not be less than an amount equal to the average of the middle-market
closing price for an Ordinary Share or ADS of the Company on the London or New York Stock Exchange on the three consecutive dealing days
immediately before the date of grant (or as otherwise agreed with HM Revenue & Customs). Where the option is an option to subscribe, the
price payable upon exercise cannot be less than the nominal value of an Ordinary Share of the Company.
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24 EmployEE CoSTS ANd ShARE opTIoN plANS FoR EmployEES CoNTINuEd
Exercise of options
An option will normally be exercisable between three and 10 years following its grant provided any relevant performance condition has been
satisfied. Options may be satisfied by the issue of new Ordinary Shares or by existing Ordinary Shares purchased in the market. The Remuneration
Committee sets the policy for the Company’s operation of the plan including as regards whether any performance target(s) will apply to the
grant and/or exercise of each eligible employee’s option. Options normally lapse on cessation of employment. Exercise is, however, permitted
for a limited period following cessation of employment either for reasons of injury or disability, redundancy or retirement, or at the discretion of
the Remuneration Committee, and on an amalgamation, take-over or winding-up of the Company.
(2) SummARy oF ThE ASTRAZENECA SAvINgS-RElATEd ShARE opTIoN SChEmE ANd ThE ASTRAZENECA SAvINgS-RElATEd ShARE opTIoN plAN
(‘SAyE SChEmES’)
The AstraZeneca Savings-Related Share Option Scheme was approved by shareholders in 1994 for a period of 10 years. The last grant of
options under this scheme was made in September 2002. In 2003, shareholders approved the AstraZeneca Savings-Related Share Option
Plan for a period of 10 years. The first grant of options under this plan was made in September 2003. The following sections apply to both the
AstraZeneca Savings-Related Share Option Scheme and the AstraZeneca Savings-Related Share Option Plan, which have broadly similar rules.
Eligibility
UK-resident employees of participating AstraZeneca companies are automatically eligible to participate.
Grant of options
Invitations to apply for options may be issued within six weeks after the announcement by the Company of its results for any period and at
other times in circumstances considered to be exceptional by the Directors. No invitations may be issued later than 10 years after the approval
of the scheme by shareholders. Options may only be granted to employees who enter into HM Revenue & Customs-approved savings
contracts with the savings body nominated by the Company, under which monthly savings of a fixed amount (currently not less than £5 nor
more than £250) are made over a period of three or five years. The number of Ordinary Shares over which an option is granted will be such that
the total amount payable on its exercise will be the proceeds on maturity of the related savings contract. No payment will be required for the
grant of an option. Options are not transferable.
Individual participation
Monthly savings by an employee under all savings contracts linked to options granted under any Save As You Earn scheme may not exceed
£250 or such lower amounts as may be determined by the Directors.
Acquisition price
The price per Ordinary Share payable upon the exercise of an option will not normally be less than the higher of:
(a) 90% of the arithmetical average of the middle-market quotations for an Ordinary Share on the London Stock Exchange on three
consecutive dealing days shortly before the date on which invitations to apply for options are issued (provided that no such day may fall
before the Company last announced its results for any period) or such other dealing day or days falling within the six week period for the
issue of invitations, as the Directors may decide; and
(b) the nominal value of an Ordinary Share (unless the option is expressed to relate only to existing Ordinary Shares).
Exercise of options
An option will normally be exercisable only for six months commencing on the third or fifth anniversary of the commencement of the related
savings contract. Options are satisfied by the issue of new Ordinary Shares. Options normally lapse on cessation of employment. Exercise is,
however, permitted for a limited period (irrespective of the period during which the option has been held) following cessation of employment in
certain compassionate circumstances or where an option has been held for more than three years (except on dismissal for misconduct) and
on an amalgamation, take-over or winding-up of the Company.
(3) SummARy oF ThE ZENECA 1994 ExECuTIvE ShARE opTIoN SChEmE (‘1994 SChEmE’)
The Zeneca 1994 Executive Share Option Scheme was introduced in 1994. The last date for the grant of options was 16 March 2000 and the
scheme has been replaced by the AstraZeneca Share Option Plan. Options granted under the 1994 Scheme are normally exercisable between three
and 10 years following grant, provided the relevant performance condition has been satisfied. Options are satisfied by the issue of new Ordinary
Shares. The performance condition applicable to the 1994 Scheme was that earnings per share must have grown by at least the increase in
the UK Retail Price Index over three years plus 3% per annum. Satisfaction of this condition was tested annually by reference to the audited financial
statements. All options granted under the 1994 Scheme have become exercisable, the performance conditions having been satisfied.
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24 EmployEE CoSTS ANd ShARE opTIoN plANS FoR EmployEES CoNTINuEd
AstraZeneca Share Option Plan 1994 Scheme SAYE Schemes ASVIP
Shares
Options WAEP
1
Options WAEP
1
Options WAEP
1
under option WAEP
1
’000 pence ’000 pence ’000 pence ’000 SEK
At 1 January 2006
Options outstanding 50,079 2670 5,958 2658 3,438 2053 309 442
Movements during 2006
Options granted 9,266 2977 280 3001
Options exercised (18,543) 2708 (4,038) 2665 (289) 2278
Options forfeited (1,078) 2669 (14) 2862 (218) 2473 (309) 442
Weighted average fair value of
options granted during the year 857 943
At 31 December 2006
Options outstanding 39,724 2428 1,906 2371 3,211 2087
Movements during 2007
Options granted 7,312 2737 1,074 2164
Options exercised (2,770) 2648 (321) 2426 (1,327) 1785
Options forfeited (1,706) 2745 (95) 2603 (238) 2528
Weighted average fair value of
options granted during the year 682 616
At 31 December 2007
Options outstanding 42,560 2451 1,490 2364 2,720 2226
Movements during 2008
Options granted 14,858 1887 483 2398
Options exercised (2,577) 2204 (99) 2620 (675) 2062
Options forfeited (2,273) 2622 (106) 2594 (388) 2291
Weighted average fair value of
options granted during the year 404 499
At 31 December 2008
Options outstanding 52,568 2978 1,285 2934 2,140 2304
Range of exercise prices 1882p to 2505p to 2164p to n/a
4381p 3049p 3001p
Weighted average remaining contractual life 2,456 days 415 days 1,193 days n/a
Options exercisable 24,788 2689 1,285 2702 75 2231 n/a
1
Weighted average exercise price.
The Astra Shareholder Value Incentive Plan (‘ASVIP’) was introduced in 1994 and last granted options in March 2000. There were no options
outstanding under this scheme as at 31 December 2008.
The fair value of options is estimated at the date of grant using the Black-Scholes option pricing model. The following table gives the
assumptions applied to the options granted in the respective periods shown. Expectations of early exercise are incorporated into the model.
2008 2007 2006
Average share price (pence) 2295 2599 3020
Weighted average exercise price (pence)
AstraZeneca Share Option Plan 1887 2737 2977
SAYE schemes 2398 2164 3001
Expected volatility (%) 25.0 25.0 30.0
Dividend yield (%) 3.4 2.6 2.3
Risk-free interest rate (%) 4.3 4.8 4.3
Expected lives: AstraZeneca Share Option Plan (years) 6.0 6.0 6.0
Expected lives: SAYE schemes (years) 4.0 4.3 4.1
The expected volatility is based on the historic volatility (calculated based on the weighted average remaining life of the share options) adjusted
for any expected changes to future volatility due to publicly available information.
No other features of options granted were incorporated into the measurement of fair value.
The charge for share-based payments in respect of share options is $125m (2007: $124m; 2006: $125m) which is comprised entirely of
equity-settled transactions.
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25 CommITmENTS ANd CoNTINgENT lIAbIlITIES
2008 2007 2006
$m $m $m
Commitments
Contracts placed for future capital expenditure not provided for in these accounts 332 571 383
Included in the above total are contracts related to certain product purchase and licence agreements with contingent consideration, the
amounts of which are variable depending upon particular ‘milestone’ achievements. Sales of the products to which these milestones relate
could give rise to additional payments, contingent upon the sale levels achieved. AstraZeneca generally has the right to terminate these
agreements at no cost. Guarantees and contingencies arising in the ordinary course of business, for which no security has been given, are
not expected to result in any material financial loss.
ARRANgEmENTS wITh mERCk
Introduction
In 1982, Astra AB set up a joint venture with Merck & Co., Inc. (“Merck”) for the purposes of selling, marketing and distributing certain Astra
products in the US. In 1998, this joint venture was restructured (the “Restructuring”). Under the agreements relating to the Restructuring
(the “Agreements”), a US limited partnership was formed, in which Merck is the limited partner and AstraZeneca is the general partner, and
AstraZeneca obtained control of the joint venture’s business subject to certain limited partner and other rights held by Merck and its affiliates.
These rights provide Merck with safeguards over the activities of the partnership and place limitations on AstraZeneca’s commercial freedom
to operate. The Agreements provided for:
a payment to Merck in the event of a business combination between Astra and a third party in order for Merck to relinquish certain claims to >
that third party’s products;
annual contingent payments; and >
termination arrangements which cause Merck to relinquish its interests in AstraZeneca’s products and activities in stages, some of which >
are mandatory and others optional.
These elements are discussed in further detail below, together with a summary of their accounting treatments.
Payment in the event of a business combination
On the merger of Astra and Zeneca, a one-time Lump Sum Payment of $809m was triggered. As a result of this payment, Merck relinquished
any claims it may have had to Zeneca products.
This payment was expensed at the point of merger since it caused no incremental benefits over the prior years’ aggregate Astra and Zeneca
performance to accrue to the merged AstraZeneca entity.
Annual contingent payments
AstraZeneca makes ongoing payments to Merck based on sales of certain of its products in the US (the “contingent payments” on the
“agreement products”). As a result of the merger of Astra and Zeneca in 1999, these contingent payments (excluding those in respect of
Prilosec and Nexium) could not be less than annual minimum sums between 2002 and 2007 ranging from $125m to $225m. AstraZeneca’s
payments exceeded the minimum level in all years.
AstraZeneca will continue to make contingent payments to Merck until at least 2012. Contingent payments (excluding those in respect of Prilosec
and Nexium) will cease in 2010 if AstraZeneca exercises the First Option (as discussed under “First Option” below); contingent payments in respect
of Prilosec and Nexium will cease in 2012 if AstraZeneca exercises the Second Option at that time (as discussed under “Second Option” below).
The annual contingent payments on agreement products are expensed as incurred.
Termination arrangements
The Agreements provided for arrangements and payments under which, subject to the exercise of certain options, the rights and interests in
AstraZeneca’s activities and products held by Merck immediately prior to the merger would be terminated, including details of:
the Advance Payment; >
the Partial Retirement; >
the True-Up; >
the Loan Note Receivable; >
the First Option; and >
the Second Option. >
Advance Payment
The merger between Astra and Zeneca in 1999 triggered the first step in the termination arrangements. Merck relinquished all rights, including
contingent payments on future sales, to potential Astra products with no existing or pending US patents at the time of the merger. As a result,
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AstraZeneca now has rights to such products and is relieved of potential obligations to Merck and restrictions in respect of those products
(including annual contingent payments), affording AstraZeneca substantial freedom to exploit the products as it sees fit.
At the time of the merger, the Advance Payment was paid. It was calculated as the then net present value of $2.8bn discounted from 2008 to
the date of merger at a rate of 13% per annum and amounted to $967m. It was subject to a true-up in 2008 (as discussed under “True-Up” below).
Partial Retirement
In March 2008, there was a partial retirement of Merck’s limited partnership interest by payment to Merck of an amount calculated as a multiple
of the average annual contingent payments from 2005 to 2007 on the relevant products, plus $750m. The payment was $4,271m. The amount
payable under the Partial Retirement was estimated to be $4.3bn in the 2007 financial statements.
Upon the Partial Retirement, Merck’s rights in respect of certain of the agreement products ended. The products covered by the Partial
Retirement include Toprol-XL, Pulmicort, Rhinocort and Symbicort.
True-Up
In 2008, in accordance with the Agreements, there was a True-Up of the Advance Payment. The True-Up amount was based on a multiple
of the average annual contingent payments from 2005 to 2007 in respect of all the agreement products with the exception of Prilosec and
Nexium (subject to a minimum of $6.6bn), plus other defined amounts (totalling $912m). In accordance with the Agreements, the calculated
amount was then reduced by the Appraised Value (as discussed under “First Option” below), the Partial Retirement and the Advance Payment
(at its undiscounted amount of $2.8bn). This True-Up amount was settled in an amount equal to $241m owed by Merck to AstraZeneca.
The amount payable under the True-Up was estimated to be $0.2bn in the 2007 financial statements, payable by Merck to AstraZeneca.
Loan Note Receivable
Included in the assets and liabilities covered by the Restructuring was a loan note receivable by AstraZeneca from Merck with a face value of
$1.38bn. In 2008, at the same time as the settlement of the Partial Retirement and the True-Up, Merck settled the loan note receivable by
paying AstraZeneca $1.38bn.
If Merck had exercised the First Option in 2008, the net minimum payment that would have been made to Merck would have been $3.3bn,
being the minimum combined payments of $4.7bn specified in the Agreements on the Partial Retirement, the True-Up and First Option, less
the repayment of the loan note of $1.38bn. In accounting for the Restructuring in 1998, the loan note was included in the determination of the
fair values of the assets and liabilities to be acquired. At that time, the loan note was ascribed a fair value of zero on acquisition and on the
balance sheet, because it was estimated that the net minimum payment of $3.3bn equated to the fair value of the rights to be acquired under
the Partial Retirement, True-Up and First Option.
First Option
In accordance with the Agreements, in 2008 a calculation was made of the Appraised Value, being the net present value of the future
contingent payments in respect of all agreement products not covered by the Partial Retirement, other than Prilosec and Nexium. The
Appraised Value was calculated in 2008 as $647m. In the 2007 financial statements, this amount was estimated to be $0.6bn.
Payment of the Appraised Value to Merck in March 2008 would have taken place only if Merck had exercised the First Option in 2008.
Merck did not exercise this option. AstraZeneca may exercise the First Option in 2010 for a sum equal to the 2008 Appraised Value.
Upon exercise of the First Option, Merck will relinquish its rights over the agreement products not covered by the Partial Retirement, other than
Nexium and Prilosec. If AstraZeneca does not exercise the First Option, the contingent payment arrangements in respect of these agreement
products will continue (as will AstraZeneca’s other obligations and restrictions in respect of these products) and the Appraised Value will not be
paid. Products covered by the First Option include Entocort, Atacand, Plendil and certain compounds still in development.
Second Option
Provided that the First Option is exercised, AstraZeneca may exercise a Second Option to repurchase Merck’s interests in Prilosec and Nexium
in the US. This option is exercisable by AstraZeneca in 2012, or in 2017, or if combined annual sales of the two products fall below a minimum
amount. AstraZeneca’s exercise of the Second Option will end the contingent payments in respect of Prilosec and Nexium and will effectively
end AstraZeneca’s relationship with, and obligations to, Merck (other than some residual manufacturing arrangements). The exercise price for
the Second Option is the net present value of the future annual contingent payments on Prilosec and Nexium as determined at the time of
exercise. If the Second Option is exercised, Merck will then have relinquished all its interests in the partnership and the agreement products,
including rights to contingent payments. The exercise price of the Second Option cannot be determined at this time.
Accounting treatment of termination arrangements
AstraZeneca considers that the termination arrangements described above represent the acquisition, in stages, of Merck’s interests in the
partnership and agreement products (including Merck’s rights to contingent payments) and depend, in part, on the exercise of the First and
Second Options. The effects will only be reflected in the Financial Statements as these stages are reached. If and when all such payments are
made, AstraZeneca will have unencumbered discretion in its operations in the US market.
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25 CommITmENTS ANd CoNTINgENT lIAbIlITIES CoNTINuEd
AstraZeneca anticipates that the benefits that accrue under all of the termination arrangements arise:
Currently, from the substantial freedom over products acquired or discovered post-merger. >
On occurrence of each stage of such arrangements, from enhanced contributions from, and substantial freedom over, those products that >
have already been launched (for example, Pulmicort, Symbicort, Rhinocort and Atacand), and those that are in development.
Economic benefits include relief from contingent payments, anticipated cost savings from cessation of manufacturing arrangements and >
other cost efficiencies, together with the strategic advantages of increased freedom to operate.
The Advance Payment has been accounted for as an intangible asset and is being amortised over 20 years. This approach reflects the fact
that, under the Agreements, AstraZeneca has acquired rights relieving it of potential obligations and restrictions in respect of Astra products
with no existing or pending patents at the time of merger. Although these rights apply in perpetuity, the period of amortisation of 20 years has
been chosen to reflect the typical timescale of development and marketing of a product.
The net payment made in 2008, consisting of the Partial Retirement of $4.271bn less the True-Up of $241m and loan note receivable of $1.38bn,
in total $2.6bn, has been capitalised as intangible assets.
Part of the net payment made in 2008 resulted in AstraZeneca acquiring Merck’s interests in certain AstraZeneca products, including Pulmicort,
Rhinocort, Symbicort and Toprol-XL. Consequently AstraZeneca no longer has to make contingent payments on these products to Merck and
has obtained the ability to fully exploit these products and to fully exploit other opportunities in the Respiratory therapy area that AstraZeneca
was previously prevented from doing by Merck’s interests in these products. Intangible assets aggregating $994m have been recognised in
respect of these acquired product rights and these are being amortised over various periods, giving rise to an annual expense of approximately
$60m going forward.
The balance of the net payment made in 2008 represents a payment on account for the product rights that will be acquired in the event that
the First and the Second Options are exercised by AstraZeneca. Intangible assets aggregating $1.656bn have been recognised in the year in
relation to the payment. This balance will not be subject to amortisation until each of the options is exercised and the related product rights are
acquired. Should it become probable that the First Option will not be exercised, all the payments on account will be expensed immediately. If
after the First Option has been exercised it becomes probable that the Second Option will not be exercised, the payments on account for the
product rights to be acquired under the Second Option will be expensed immediately.
Environmental costs and liabilities
The Group’s expenditure on environmental protection, including both capital and revenue items, relates to costs which are necessary for
implementing internal systems and programmes and meeting legal and regulatory requirements for processes and products.
They are an integral part of normal ongoing expenditure for carrying out the Group’s research, manufacturing and commercial operations
and are not separated from overall operating and development costs. There are no known changes in legal, regulatory or other requirements
resulting in material changes to the levels of expenditure for 2006, 2007 or 2008.
In addition to expenditure for meeting current and foreseen environmental protection requirements, the Group incurs costs in investigating and
cleaning up land and groundwater contamination. In particular, AstraZeneca and/or its affiliates have environmental liabilities at some currently
or formerly owned, leased and third party sites.
In the US, the AstraZeneca affiliate, Zeneca Inc., and/or its indemnitees, have been named as potentially responsible parties (PRPs) or
defendants at approximately 17 sites where Zeneca Inc. is likely to incur future investigation, remediation or operation and maintenance
costs under federal or state, statutory or common law environmental liability allocation schemes. Similarly, the AstraZeneca affiliate, Stauffer
Management Company LLC (SMC), which was established in 1987 to own and manage certain assets of Stauffer Chemical Company
acquired that year, and/or its indemnitees, have been named as PRPs or defendants at approximately 28 sites where SMC is likely to incur
future investigation, remediation or operation and maintenance costs under federal or state, statutory or common law environmental liability
allocation schemes. In Europe and other parts of the world outside the US, AstraZeneca has given indemnities to third parties in respect of
approximately 45 sites. These environmental liabilities arise from legacy operations that are not part of the Group’s current pharmaceuticals
business and, at most of these sites, remediation, where required, is either completed or nearing completion.
AstraZeneca has made provisions for the estimated costs of future environmental investigation, remediation and operation and maintenance
activity beyond normal ongoing expenditure for maintaining the Group’s research and development and manufacturing capacity and product ranges
where a present obligation exists; it is probable that such costs will be incurred and can be estimated reliably. With respect to such estimated
future costs, there were provisions at 31 December 2008 in the aggregate of $118.9m, which mainly relate to the US. These provisions do not
include possible additional costs that are not currently probable. Where we are jointly liable or otherwise have cost sharing agreements with third
parties, we reflect only our share of the obligation. Where the liability is insured in part or in whole by insurance or other arrangements for
reimbursement, an asset is recognised to the extent that this recovery is virtually certain.
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It is possible that the Company, or its affiliates, could incur future environmental costs beyond the extent of our current provisions. The extent
of such possible, additional costs is inherently difficult to estimate due to a number of factors, including, but not limited to: (1) the nature and
extent of claims that may be asserted in the future; (2) whether the Company or any of its affiliates has or will have any legal obligation with
respect to asserted or unasserted claims; (3) the type of remedial action, if any, that may be selected at sites where the remedy is presently not
known; (4) the potential for recoveries from or allocation of liability to third parties; and (5) the length of time that the environmental investigation,
remediation and liability allocation process can take. Notwithstanding and subject to the foregoing, it is estimated that potential additional loss
for future environmental investigation, remediation and remedial operation and maintenance activity above and beyond our provisions could be,
in aggregate, in the order of $15-30m, which relates solely to the US.
Legal proceedings
AstraZeneca is involved in various legal proceedings considered typical to its businesses, including litigation relating to employment, product
liability, commercial disputes, infringement of intellectual property rights, the validity of certain patents, anti-trust, securities laws and
governmental investigations. The more significant matters are discussed below.
Most of the claims involve highly complex issues. Often, these issues are subject to substantial uncertainties and therefore the probability of a
loss, if any, being sustained and an estimate of the amount of any loss are difficult to ascertain. Consequently, for a majority of these claims, it
is not possible to make a reasonable estimate of the expected financial effect, if any, that will result from ultimate resolution of the proceedings.
In these cases, AstraZeneca discloses information with respect to the nature and facts of the cases.
With respect to each of the legal proceedings described below, other than those which have been disposed of, we are unable to make
estimates of the possible loss or range of possible losses at this stage, other than where noted in the case of the European Commission fine,
which is under appeal, and the Class 2 and 3 settlements in the Average Wholesale Price litigation. We also do not believe that disclosure of
the amount sought by plaintiffs, if that is known, would be meaningful with respect to those legal proceedings. This is due to a number of
factors including: the stage of the proceedings (in many cases trial dates have not been set) and the overall length and extent of pre-trial
discovery; the entitlement of the parties to an action to appeal a decision; clarity as to theories of liability, damages and governing law;
uncertainties in timing of litigation; and the possible need for further legal proceedings to establish the appropriate amount of damages, if any.
However, although there can be no assurance regarding the outcome of any of the legal proceedings referred to in this Note 25 to the Financial
Statements, based on management’s current and considered view of each situation, we do not currently expect them to have a materially adverse
effect on our financial position. This position could of course change over time, not least because of the factors referred to in the above paragraph.
In cases that have been settled or adjudicated, or where quantifiable fines and penalties have been assessed and which are not subject to
appeal, or where a loss is probable and we are able to make a reasonable estimate of the loss, we indicate the loss absorbed or the amount
of the provision accrued. No provisions have been made for any such claims and legal costs incurred discussed below other than the
European Commission fine which has been paid and the settlement with certain parties under the Average Wholesale Price litigation.
Where it is considered that the Group is more likely than not to prevail, legal costs involved in defending the claim are charged to the income
statement as they are incurred.
Where it is considered that the Group has a valid contract which provides the right to reimbursement (from insurance or otherwise) of legal
costs and/or all or part of any loss incurred or for which a provision has been established, the best estimate of the amount expected to be
received is recognised as an asset.
Assessments as to whether or not to recognise provisions or assets and of the amounts concerned usually involve a series of complex
judgements about future events and can rely heavily on estimates and assumptions. AstraZeneca believes that the provisions recorded are
adequate based on currently available information and that the insurance recoveries recorded will be received. However, given the inherent
uncertainties involved in assessing the outcomes of these cases and in estimating the amount of the potential losses and the associated
insurance recoveries, we could in future periods incur judgments or insurance settlements that could have a material adverse effect on our
results in any particular period.
Intellectual property claims include challenges to the Group’s patents on various products or processes and assertions of non-infringement of
patents. A loss in any of these cases could result in loss of patent protection on the related product. The consequences of any such loss could
be a significant decrease in sales of the product, which could materially affect the future results of the Group. The lawsuits pending against
companies that have filed ANDAs in the US, seeking to market generic forms of products sold by the Group prior to the expiry of the applicable
patents covering these products, typically include allegations of non-infringement, invalidity and unenforceability of these patents. In the event that
the Group is not successful in these actions or the statutory 30-month stay expires before a ruling is obtained, the companies involved will also have
the ability, subject to FDA approval, to introduce generic versions of the product concerned.
AbRAxANE
®
(pAClITAxEl pRoTEIN-bouNd pARTIClES FoR INjECTAblE SuSpENSIoN) (AlbumIN-bouNd)
AstraZeneca is party to an agreement with Abraxis BioScience, LLC, (Abraxis) to co-promote Abraxane
®
. In July 2006, Elan Pharma International
Limited filed a lawsuit in the US District Court for the District of Delaware against Abraxis alleging that Abraxis infringes two US patents in connection
with the marketing, use and sale of Abraxane
®
. Elan did not name AstraZeneca in the complaint, nor did it seek an injunction in respect of
AstraZeneca’s sales of Abraxane
®
. There was a jury judgment against Abraxis in the litigation in June 2008, which had no impact on AstraZeneca.
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Subsequently, in November 2008, AstraZeneca entered into a conditional agreement with Abraxis under which Abraxis would re-acquire
exclusive rights to market Abraxane in the US, subject to the approval of the board of Abraxis’ parent company. Pursuant to the agreement, the
board of Abraxis’ parent company ended the Co-Promotion Agreement on 2 January 2009. Under the agreement, Abraxis will pay AstraZeneca
a $268m fee on 31 March 2009. This matter will no longer be reported.
AccolAte (ZAFIRlukAST)
In May 2008, AstraZeneca received a Paragraph IV Certification notice-letter from Dr. Reddy’s Laboratories Ltd and Dr. Reddy’s Laboratories,
Inc. (together Dr. Reddy’s) that it had submitted an ANDA to the FDA for Accolate. AstraZeneca lists seven patents referencing Accolate in the FDAs
Orange Book. Dr. Reddy’s did not challenge two listed patents, US Patent Nos. 4,859,692 and 5,583,152, which expire in September 2010. As a
result, Dr. Reddy’s cannot market its zafirlukast product before the 2010 expiration date of these two patents. Dr. Reddy’s challenged the five
remaining patents alleging non-infringement, invalidity or unenforceability. In June 2008, AstraZeneca commenced patent infringement litigation
against Dr. Reddy’s in the US District Court for the District of New Jersey for infringement of three of the five remaining listed patents, US Patent
Nos. 5,319,097, 5,482,963 and 6,143,775. The remaining two patents listed in the FDA Orange Book have expiration dates in December 2011
and March 2014. In July 2008, Dr. Reddy’s responded to AstraZeneca’s pleading. Discovery proceeds. No trial date has been set.
AstraZeneca has full confidence in, and will vigorously defend and enforce, its intellectual property protecting Accolate.
AtAcAnd (CANdESARTAN CIlExETIl)
In March and April 2008, AstraZeneca and Takeda received Paragraph IV Certification notice-letters from Teva Pharmaceuticals USA Inc. (Teva),
notifying AstraZeneca and Takeda that it had filed an ANDA with the FDA, seeking approval to market a generic version of Atacand in the 4mg,
8mg, 16mg and 32mg doses prior to the expiration of US Patent No. 5,534,534 (the ’534 patent), which expires in 2013. AstraZeneca lists
three patents referencing Atacand in the FDAs Orange Book. Teva’s notice alleges that its products do not infringe the ’534 patent. Teva did
not challenge the remaining two listed compound patents, which expire in 2011 and 2012 respectively. As a result, Teva cannot market
candesartan cilexetil before June 2012. AstraZeneca and Takeda did not bring an action for patent infringement in respect of the ’534 patent.
In July 2008, AstraZeneca and Takeda received a Paragraph IV Certification notice-letter from Mylan, Inc. (Mylan) relating to an ANDA
submitted by Matrix Laboratories Ltd with respect to all four dose forms of candesartan cilexetil, alleging non-infringement of the ’534 patent.
Mylan did not challenge the two compound patents listed in the FDA Orange Book. As a result, Mylan cannot market candesartan cilexetil
before June 2012. AstraZeneca did not bring an action for patent infringement in respect of the ’534 patent.
AtAcAnd Hct (CANdESARTAN CIlExETIl ANd hydRoChloRoThIAZIdE)
In September 2008, AstraZeneca received a Paragraph IV Certification notice-letter from Mylan, Inc. (Mylan) notifying AstraZeneca that it
had submitted an ANDA for Atacand HCT, a combination product containing candesartan cilexetil and hydrochlorothiazide in the 32/12.5mg
and 16/12.5mg dose forms. AstraZeneca lists five patents referencing Atacand HCT in the FDAs Orange Book. Mylan’s notice alleges
non-infringement, invalidity or unenforceability in respect of US Patent Nos. 5,534,534, 5,721,263 and 5,958,961. Mylan did not challenge
the two listed compound patents, the latter of which expires in June 2012. As a result, Mylan cannot market candesartan cilexetil and
hydrochlorothiazide before June 2012. AstraZeneca did not file a complaint for patent infringement.
crestor (RoSuvASTATIN)
Product liability
From 2004 to present, AstraZeneca in the US was served with 16 individual lawsuits in various US jurisdictions, alleging injury in association
with the use of Crestor. Fourteen of the cases were dismissed in early stages, and another was dismissed after the court granted AstraZeneca’s
motion for summary judgment in June 2007. These decisions were not appealed by the plaintiffs. AstraZeneca intends to vigorously defend the
remaining case, which is still in its preliminary stage.
Patent litigation – US
AstraZeneca lists three patents referencing Crestor in the FDA Orange Book: No. RE37,314 covering the active ingredient (the ’314 patent),
No. 6,316,460 covering formulations (the ’460 patent), and No. 6,858,618 covering medical use (the ’618 patent). In the fourth quarter of 2007,
AstraZeneca received Paragraph IV Certification notice-letters from Apotex, Inc. (Apotex), Aurobindo Pharma Limited (Aurobindo), Cobalt
Pharmaceuticals Inc. and Cobalt Laboratories Inc. (together Cobalt), Glenmark Pharmaceuticals Inc. USA (Glenmark), Mylan Pharmaceuticals,
Inc. (Mylan), Par Pharmaceutical, Inc. (Par), Sandoz, Inc. (Sandoz), Sun Pharmaceuticals Industries Limited (Sun) and Teva Pharmaceuticals
USA, Inc. (Teva). Each entity notified AstraZeneca that it had submitted an ANDA to the FDA for approval to market Crestor 5mg, 10mg, 20mg
and 40mg rosuvastatin calcium tablets prior to the expiration of one or more of AstraZeneca’s three FDA Orange Book-listed patents. The
notice-letters informed AstraZeneca that each respective ANDA contained a Paragraph IV Certification alleging non-infringement, invalidity
or unenforceability of one or more of AstraZeneca’s three patents. In December 2007, in response to notice-letters from seven of the nine
ANDA-filers, AstraZeneca Pharmaceuticals LP, AstraZeneca UK Limited, IPR Pharmaceuticals, Inc., and AstraZeneca’s licensor, Shionogi
Seiyaku Kabushiki Kaisha (Shionogi), filed separate lawsuits in the US District Court for the District of Delaware, against Apotex, Aurobindo,
Cobalt, Mylan, Par, Sandoz and Sun for infringement of the patent covering rosuvastatin calcium, the active ingredient in Crestor tablets.
AstraZeneca did not file patent infringement actions against Teva and Glenmark because they did not seek approval to market products before
the 2016 expiration date of the patent covering the active ingredient. In addition to filing actions in the US District Court for the District of
Delaware, for procedural reasons, AstraZeneca Pharmaceuticals LP, AstraZeneca UK Limited, IPR Pharmaceuticals, Inc. and Shionogi filed
three duplicate patent infringement actions against Mylan, Aurobindo and Cobalt in US District Courts in West Virginia, New Jersey and Florida
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respectively. Aurobindo answered the duplicate action in New Jersey. After Mylan and Cobalt conceded jurisdiction of the Delaware District
Court in January 2008, AstraZeneca dismissed the duplicate actions in West Virginia and Florida.
In January 2008, each of the seven ANDA-filers sued by AstraZeneca in the District of Delaware for infringement of the ’314 patent answered,
counterclaimed, or otherwise responded to AstraZeneca’s pleadings. AstraZeneca replied or responded as allowed. In response, some
defendants submitted jurisdictional motions seeking dismissals of parties and claims. The District Court heard oral argument on the jurisdictional
motions in July 2008. In November 2008, the court issued a magistrate’s Report and Recommendation Regarding Motions to Dismiss deciding
the defendants’ various jurisdictional motions. In December 2008, Aurobindo filed objections to the Report. In January 2009, the Court adopted
the magistrate’s recommendations in respect of all parties except as to Aurobindo and its pending objections. Later in January 2009, AstraZeneca
responded to Aurobindo’s objections.
Although AstraZeneca did not sue Apotex for infringement of the ’460 patent, in March 2008 Apotex filed a declaratory judgment lawsuit
against AstraZeneca based on AstraZeneca’s ’460 patent in the US District Court, Middle District of Florida.
In March 2008, AstraZeneca moved before the Judicial Panel on Multi-District Litigation (JPMDL) for co-ordination and consolidation of all
Crestor pre-trial matters by the Delaware Court. In June 2008, the JPMDL granted AstraZeneca’s motion for co-ordination and consolidation
in the District of Delaware of all current ANDA matters involving Crestor. In June 2008, the JPMDL ordered Apotex’s in Florida declaratory
judgment action against AstraZeneca and AstraZeneca’s duplicate suit against Aurobindo in the District of New Jersey transferred to the
District of Delaware for pre-trial co-ordination. In September 2008, Apotex voluntarily dismissed its transferred Florida declaratory judgment
lawsuit against AstraZeneca.
In their responses to AstraZeneca’s complaints, Cobalt, Par and Sandoz pleaded declaratory judgment counterclaims based on the ’460 patent
or the ’618 patent or a third unlisted AstraZeneca patent directed to a crystalline form of rosuvastatin. Those counterclaims were later dismissed.
In June 2008, Teva notified AstraZeneca that it had amended its previously filed ANDA for approval to market Crestor rosuvastatin calcium
tablets. Teva’s amended ANDA contained a Paragraph IV Certification alleging non-infringement and invalidity in respect of AstraZeneca’s
’314 patent. In July 2008, AstraZeneca Pharmaceuticals LP, AstraZeneca UK Limited, IPR Pharmaceuticals, Inc., and AstraZeneca’s licensor,
Shionogi, filed a lawsuit in the US District Court for the District of Delaware, against Teva for infringement of the ’314 patent. In July 2008,
Teva answered AstraZeneca’s pleading.
In September 2008, the Delaware District Court issued an amended scheduling order covering all of the Crestor ANDA matters subject to the
Multi-District Litigation order, including the new lawsuit directed to Teva’s amended ANDA. The consolidated matter proceeds.
In October 2008, in a separate action, Teva Pharmaceuticals Industries Ltd., Teva’s Israeli parent corporation (Teva Ltd.), filed a patent
infringement lawsuit against AstraZeneca Pharmaceuticals LP, AstraZeneca PLC, AstraZeneca UK Limited and IPR Pharmaceuticals, Inc.
(together AstraZeneca) in the Eastern District of Pennsylvania. The complaint alleges that the manufacture, use and sale of Crestor 5mg, 10mg,
20mg and 40mg tablets infringe a formulation patent owned by Teva Ltd. In January 2009, AstraZeneca responded to Teva Ltd’s pleading.
Patent litigation – Canada
In September 2008, AstraZeneca Canada Inc. received a Notice of Allegation from Novopharm Limited (Novopharm) in respect of Canadian
Patents Nos. 2,072,945 (the ’945 patent) and 2,313,783 (the ’783 patent) listed on the Patent Register in Canada for Crestor. Novopharm
claims that the ’945 patent is invalid and that the ’783 patent has not been infringed. AstraZeneca responded by commencing a court
application in October 2008 under the Patented Medicines (Notice of Compliance) Regulations, seeking an order prohibiting the Minister
of Health from issuing a Notice of Compliance (marketing approval) to Novopharm until after expiry of the patents.
In November 2008, AstraZeneca Canada Inc. received a Notice of Allegation from Apotex in respect of the Canadian ’945 and ’783 patents listed on
the Patent Register in Canada for Crestor. Apotex claims that the ’945 patent is invalid and that the ’783 patent would not be infringed and is invalid.
AstraZeneca responded by commencing a court application in December 2008 under the Patented Medicines (Notice of Compliance) Regulations,
seeking an order prohibiting the Minister of Health from issuing a Notice of Compliance (marketing approval) to Apotex until after expiry of the patents.
As a consequence of AstraZeneca Canada’s legal actions seeking prohibition orders, neither Novopharm nor Apotex can obtain a Notice of
Compliance for its rosuvastatin calcium tablets until the earlier of the disposition of the respective court application in its favour or, unless a
Prohibition Order is granted, 24 months after the date on which the respective court application was commenced (assuming its regulatory
submission is approvable by that date).
AstraZeneca has full confidence in, and will vigorously defend and enforce, its intellectual property protecting Crestor.
entocort ec (budESoNIdE)
AstraZeneca lists two patents in the FDA Orange Book referencing Entocort EC. In April 2008, AstraZeneca received a Paragraph IV Certification
notice-letter from Barr Laboratories (Barr) notifying AstraZeneca that it had submitted an ANDA to the FDA seeking approval to market a generic
form of AstraZeneca’s Entocort EC prior to the expiration of the two patents. Barr’s notice alleges non-infringement and invalidity. In May 2008,
AstraZeneca filed a patent infringement action against Barr in the US District Court for the District of Delaware. In June 2008, Barr responded
and filed counterclaims alleging non-infringement and invalidity. No trial date has been set.
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In June 2008, AstraZeneca received another Paragraph IV Certification notice-letter on behalf of generic drug manufacturer Mylan Pharmaceuticals
Inc. (Mylan), that it had submitted an ANDA to the FDA for approval to market a generic version of AstraZeneca’s Entocort EC prior to the expiration
of the patents listed in the FDA Orange Book. Mylan claims that each of the two patents covering Entocort EC is either invalid or will not be infringed
by its proposed ANDA product. In July 2008, AstraZeneca filed a complaint for patent infringement against Mylan in the US District Court for the
District of Delaware. In August 2008, Mylan responded by alleging non-infringement and invalidity of the patents-in-suit. No trial date has been set.
AstraZeneca has full confidence in, and will vigorously defend and enforce, its intellectual property protecting Entocort EC.
etHyol (AmIFoSTINE)
In April 2008, the FDA approved Sun Pharmaceutical Industries Limited’s (Sun) generic amifostine product, which Sun launched shortly
thereafter. An active infringement action has been brought against Sun as it pertains to certain patents to which AstraZeneca, through its
acquisition of MedImmune, has rights. There was no material change to the status of that litigation in 2008.
Settlement discussions have occurred between the parties, and the Court is scheduled to hear Sun’s motion for summary judgment in
February 2009. MedImmune believes that the trial of this matter will be scheduled for late 2009.
exAntA (xImElAgATRAN)
Between January and March 2005, four putative and essentially similar securities class actions were filed in the US against AstraZeneca PLC,
Håkan Mogren (who currently serves as a Director of AstraZeneca PLC), Sir Tom McKillop, Jonathan Symonds and Percy Barnevik (who are
former Directors of AstraZeneca PLC). These actions were subsequently consolidated into a single action in the US District Court for the
Southern District of New York. The Consolidated Amended Complaint alleged that the defendants made materially false and misleading
statements regarding Exanta clinical trials and the status of the Exanta new drug application in the US. The plaintiffs purport to assert claims on
behalf of purchasers of AstraZeneca publicly traded securities during the period April 2003 to September 2004 under sections 10(b) and 20(a)
of the Securities Exchange Act of 1934 and SEC Rule 10b-5.
In an opinion dated 3 June 2008, the US District Court for the Southern District of New York dismissed the case in its entirety by granting the
motions to dismiss of AstraZeneca PLC and the individual defendants. Plaintiffs are currently appealing this decision to the US Court of Appeals
for the Second Circuit, except for the ruling regarding two of the four individual defendants. AstraZeneca filed its brief in response to Plaintiffs’
appeal on 14 October 2008.
AstraZeneca PLC will continue to vigorously defend itself in this matter.
IressA (gEFITINIb)
Between 2004 and 2008, seven claims were filed against AstraZeneca KK in Japan, in the Osaka and Tokyo District Courts. In six of the
claims, it is alleged that Iressa caused a fatal incidence of interstitial lung disease (ILD) in a Japanese patient. In the seventh claim, it is alleged
that Iressa caused a non-fatal incidence of ILD. AstraZeneca KK believes the claims are without merit and is defending all the cases. ILD is a
known complication of lung disease, including advanced lung cancer, regardless of treatment.
losec/PrIlosec (omEpRAZolE)
Patent litigation – US
In 2001, AstraZeneca filed a suit in the US against Andrx Pharmaceuticals, Inc. (Andrx) for infringement of US Patent No. 6,013,281
(the ’281 patent) directed to a process for making an omeprazole formulation. Andrx filed counterclaims of non-infringement, invalidity and
unenforceability for inequitable conduct during prosecution of the ’281 patent. Andrx also asserted that in addition to the ’281 patent, two
other formulation patents, numbered 4,786,505 (the ’505 patent) and 4,853,230 (the ’230 patent) were unenforceable for alleged litigation
misconduct by AstraZeneca. Both parties sought attorneys’ fees. In May 2004, the US District Court for the Southern District of New York ruled
that the ’281 patent was infringed, but also ruled that the ’281 patent was invalid.
The US District Court for the Southern District of New York dismissed Andrx’s litigation misconduct and other counterclaims and affirmative
defences, leaving intact the October 2002 decision finding the ’505 and ’230 patents not invalid and infringed by Andrx. The October 2002
decision was affirmed in all respects on appeal in December 2003. The Court entered final judgment regarding the ’281 patent in July 2004,
after determining to stay the attorneys’ fees claims pending any appeals. Andrx appealed the judgment and AstraZeneca cross-appealed.
The appeal was argued to the US Court of Appeals for the Federal Circuit in August 2006. In April 2007, the Federal Circuit affirmed the lower
court decision that the asserted claims of the ’281 patent are invalid. The Federal Circuit also concluded that AstraZeneca’s ’505 and ’230
formulation patents remained enforceable. As a result of Andrx’s infringement of the ’505 and ’230 patents, AstraZeneca was the prevailing
party against Andrx in the lower court. AstraZeneca is pursuing appropriate relief, including damages.
During 2000 and 2001, AstraZeneca had filed suits against Lek Pharmaceutical and Chemical Company d.d. and Lek Services USA, Inc.
(together Lek), Impax Laboratories Inc. (Impax), Eon Labs Manufacturing Inc. (Eon), Mylan Pharmaceuticals Inc. (Mylan), Apotex Corp. and
Apotex, Inc. (together Apotex), Torpharm, Inc. (Torpharm) and Zenith Goldline Pharmaceuticals, Inc. (now known as IVAX Pharmaceuticals, Inc.)
(IVAX). These suits followed the filing of ANDAs by these companies with the FDA concerning the companies’ intention to market generic
omeprazole products in the US. The basis for the proceedings is that the actions of all the companies infringe the ’505 and ’230 formulation
patents relating to omeprazole. The cases are proceeding under the US Hatch-Waxman legislation. The case against IVAX was dismissed
without prejudice shortly after it was filed, after IVAX withdrew its application to market generic omeprazole. During 2003, after Mylan
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commenced commercial sale of its product, AstraZeneca filed suit against Laboratorios Esteve, SA and Esteve Quimica, SA (together Esteve),
manufacturers of the omeprazole product to be distributed in the US by Mylan. In 2003 and 2004, Lek, Apotex and Impax all began commercial
sales of their generic omeprazole products. In July 2004, Lek filed a motion for summary judgment of non-infringement. In January 2005,
AstraZeneca filed suit against Teva Pharmaceutical Industries Ltd and Teva Pharmaceuticals USA, Inc. (together Teva), which are marketing and
selling Impax’s omeprazole products. The Teva case was stayed in June 2005 until liability issues in the Impax action are resolved. AstraZeneca
made claims for damages against each of the selling defendants. Anti-trust and non-infringement counterclaims were filed by Andrx, Apotex,
Torpharm, Impax, Eon, Mylan, Esteve, Teva and Lek. All defendants except Lek have also raised invalidity and unenforceability counterclaims.
The anti-trust counterclaims, as well as AstraZenecas claims for damages, have been stayed pending resolution of the patent liability issues.
Apotex, Impax and Eon have withdrawn their anti-trust counterclaims.
In January 2006, AstraZeneca withdrew its claims for damages against Impax, and as a result the Court dismissed Impax’s demand for a jury.
Impax appealed this decision on an interlocutory basis to the US Court of Appeals for the Federal Circuit, which denied the appeal, and then
to the US Supreme Court, which also denied the appeal. From April to June 2006, a consolidated bench trial on patent liability issues was
conducted, involving the remaining defendants, Mylan, Esteve, Lek, Apotex and Impax. Post-trial briefing was completed in July 2006.
In May 2007, the US District Court for the Southern District of New York upheld both formulation patents covering Prilosec. The Court found
that the generic omeprazole formulations of Impax and Apotex infringed AstraZeneca’s patents. The Court also found that the generic products
sold by Lek, Mylan and Esteve did not infringe AstraZeneca’s patents. AstraZeneca appealed the Mylan/Esteve decision to the US Court of
Appeals for the Federal Circuit. Impax and Apotex also appealed. In May 2008, all three appeals were argued before the Federal Circuit. In
June 2008, the Federal Circuit upheld the ruling that Mylan/Esteve did not infringe. In September 2008, the Federal Circuit upheld that the
generic omeprazole formulations of Impax and Apotex infringed AstraZeneca’s patents-in-suit. AstraZeneca will pursue damages and additional
remedies from Apotex, Impax and Teva, who is marketing Impax’s product.
In June 2007, AstraZeneca received a notice from Dr. Reddy’s Laboratories, Ltd and from Dr. Reddy’s Laboratories, Inc. (together Dr Reddy’s)
that Dr. Reddy’s had submitted an ANDA seeking FDA approval to market a 20mg delayed release omeprazole magnesium capsule for the
OTC market. Dr. Reddy’s seeks approval to market a generic omeprazole OTC product before the expiration of the patents listed in the FDA
Orange Book in reference to the Prilosec OTC product that is marketed by Procter & Gamble. In July 2007, AstraZeneca commenced patent
infringement litigation in the US District Court for the Southern District of New York against Dr. Reddy’s in response to Dr. Reddy’s Paragraph IV
Certification regarding Prilosec OTC. In July 2008, Dr. Reddy’s filed a motion for summary judgment of non-infringement. The Court has not
ruled on this motion. No trial date has been set.
Patent litigation – France
In June and July 2004, AstraZeneca applied in France for injunctions based on its omeprazole formulation patent against six companies for marketing
generic omeprazole. In August 2004, the applications were rejected at first instance. AstraZeneca appealed this decision and in March 2005 the
applications were rejected on appeal. In May 2004, AstraZeneca also started legal proceedings against the same companies for infringement of its
omeprazole formulation patent in France. These proceedings have been consolidated with a case challenging the validity of the patent, brought by
one of the companies against AstraZeneca. These cases have been closed due to inactivity by both parties over the last two years.
Patent litigation – Canada
AstraZeneca continues to be involved in proceedings in Canada involving various patents relating to omeprazole capsules or omeprazole
magnesium tablets. Apotex launched a generic omeprazole capsule product in Canada in January 2004.
In February 2006, the Federal Court of Appeal upheld a lower court decision that prohibited Apotex from obtaining a Notice of Compliance for
omeprazole magnesium tablets until the expiry of a relevant formulation patent in December 2008. In December 2008, the Federal Court of
Appeal dismissed Apotex’s appeal of an order dismissing a motion by Apotex to set aside a Prohibition Order.
In January 2006, AstraZeneca Canada Inc. was served with a claim in the Federal Court of Canada for payment of an undetermined sum
based on damages allegedly suffered by Apotex due to the delay from January 2002 to January 2004 in the issuance to Apotex of a Notice of
Compliance in Canada for its 20mg omeprazole capsule product. AstraZeneca believes the claim is without merit and is defending it, as well
as continuing to vigorously pursue its already pending patent infringement action against Apotex.
AstraZeneca has full confidence in, and will vigorously defend and enforce, its intellectual property protecting Losec/Prilosec.
European Commission investigation
In February 2000, the European Commission commenced an investigation relating to certain omeprazole intellectual property rights, and
associated regulatory and patent infringement litigation. The investigation is pursuant to Article 82 of the EC Treaty, which prohibits an abuse
of a dominant position. The investigation was precipitated by a complaint regarding a number of patent and other proceedings involving
AstraZeneca. AstraZeneca has, in accordance with its corporate policy, co-operated with the Commission. In July 2003, the Commission
served a Statement of Objections on AstraZeneca, referring to alleged infringements regarding the obtaining of supplementary protection
certificates for omeprazole in certain European countries; and regarding AstraZeneca’s replacement of omeprazole capsules by omeprazole
MUPS (tablets) and withdrawal of capsule marketing authorisations in three European countries. AstraZeneca replied fully to the Commission,
explaining why its actions were, in AstraZeneca’s view, lawful. An oral hearing took place in February 2004. In June 2005, the Commission
notified AstraZeneca PLC and AstraZeneca AB of its Decision to impose fines totalling €60m on the companies for infringement of European
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competition law (Article 82 of the EC Treaty and Article 54 of the EEA Agreement). The Commission alleges that the companies abused their
dominant positions in the periods between 1993 and 2000 by making a pattern of misleading representations before the patent offices and/or
courts in Belgium, Denmark, Germany, The Netherlands, Norway and the UK in regard to obtaining supplementary protection certificates for
omeprazole; and by requesting the surrender of market authorisations for omeprazole capsules in Denmark, Norway and Sweden, combined
with withdrawal of omeprazole capsules from these countries and the launch of omeprazole MUPS (tablets). AstraZeneca does not accept the
Commission’s Decision and has appealed it to the Court of First Instance. AstraZeneca denies that it had a dominant position or that it was
engaged in the behaviours as characterised by the Commission. In the meantime, the fine was fully provided for in the half-year results in 2005
through a charge to operating profit of $75m. Because it is further alleged by the Commission that these activities had the effect of hindering the
entry of the generic version of Losec and parallel trade, it is possible that third parties could seek damages for alleged losses arising from this
matter. Any such claims would be vigorously resisted.
The Oral Hearing in the above appeal to the Court of First Instance took place on 26 and 27 November 2008. The Court indicated its intention
to hand down judgment in Spring 2009.
nexIum (ESomEpRAZolE mAgNESIum)
Sales and marketing practices
AstraZeneca entities have been sued in various state and federal courts in the US in purported representative class actions involving the marketing
of Nexium. These actions generally allege that AstraZeneca’s promotion and advertising of Nexium to physicians and consumers was unfair,
unlawful and deceptive, particularly as the promotion relates to comparisons of Nexium with Prilosec. They also allege that AstraZeneca’s conduct
relating to the pricing of Nexium was unfair, unlawful and deceptive. The plaintiffs allege claims under various state consumer protection, unfair
practices and false advertising laws. The plaintiffs in these cases seek remedies that include restitution, disgorgement of profits, damages,
punitive damages, injunctive relief, attorneys’ fees and costs of suit.
The first action was brought in 2004 in the Superior Court of the State of California for the County of Los Angeles by the AFL-CIO, two
unincorporated associations, and an individual on behalf of themselves, the general public and a class of California consumers, third party
payers, cash payers and those making a co-payment. A second action was filed in the same court on behalf of a similar putative class of
consumers. Actions making substantially similar allegations were filed in 2004 and 2005 on behalf of putative classes of consumers, third party
payers, purchasers and labour management trust funds in the Circuit Court of Searcy County, Arkansas; in the Superior Court of the State of
Delaware in and for New Castle County; in the Superior Court of Massachusetts in Boston; in the US District Court for the District of Delaware
(three consolidated cases); and in the Circuit Court of the 11th Judicial Court in and for Miami-Dade County, Florida.
In September 2005, the Court in California issued a ruling on AstraZeneca’s demurrer and motion to strike in the two California actions. The
Court granted AstraZeneca’s motion with respect to the associated plaintiffs and denied the motion with respect to the individual plaintiffs,
allowing the cases of the individuals to proceed. In October 2005, the Court in Massachusetts denied AstraZeneca’s motion to dismiss.
Plaintiffs’ motions for class certification in the California and Massachusetts cases were filed in October 2007. The California plaintiffs filed an
amended class certification motion in January 2008. In June 2008, AstraZeneca filed oppositions to the class certification motions, and also
filed motions for summary judgment in California. Oral argument on the California motions was held in December 2008 and a decision is
expected by the second quarter of 2009.
In November 2005, the US District Court for the District of Delaware granted AstraZeneca’s motion to dismiss the consolidated class action
complaint. In September 2007, the US Court of Appeals for the Third Circuit affirmed the dismissal and denied plaintiffs’ petition for rehearing
en banc. In December 2007, plaintiffs filed a petition for writ a certiorari with the US Supreme Court. AstraZeneca responded to the petition
in February 2008. The petition is pending. The Delaware state case has been stayed pending the outcome of the Delaware federal cases.
In May 2006, the Arkansas State Court granted AstraZeneca’s motion to dismiss the plaintiffs’ complaint. The plaintiffs filed additional motions
and pleadings, including an amended complaint. AstraZeneca filed a motion to dismiss the amended complaint. In July 2008, the Arkansas
State Court granted AstraZeneca’s renewed motion to dismiss the plaintiffs’ amended complaint. The plaintiffs filed an appeal.
Anti-trust
In December 2006 and January 2007, several lawsuits against AstraZeneca entities, including putative class actions, were filed in the US
District Court for the District of Columbia alleging anti-trust claims of unlawful monopolisation relating to Prilosec and Nexium. Individual actions
were filed in December 2006 by Walgreen Co., Eckerd Corporation, Maxi Drug, Inc. d/b/a Brooks Pharmacy, The Kroger Co., New Albertson’s
Inc., Safeway, Inc., Hy-Vee, Inc., American Sales Company, Inc., Rite Aid Corporation, and Rite Aid Headquarters Corp. Also, putative class
actions brought on behalf of direct purchasers were filed in December 2006 by Meijer, Inc., Meijer Distribution, Inc., Louisiana Wholesale Drug
Co., Inc., and in January 2007 by Burlington Drug Co., Inc., Dik Drug Co., Inc, and King Drug Co. of Florence, Inc. The plaintiffs sought treble
damages, injunctive relief and attorney fees. All plaintiffs filed amended complaints in February 2007. In February 2008, the court dismissed all
complaints. The plaintiffs did not appeal the decision.
Patent proceedings
In October 2007, the European Patent Office (EPO) Opposition Division ruled that the European process patent EPB 0,773,940 (the ’940
patent) for Nexium is valid in amended form, despite an opposition by the German generic manufacturer, ratiopharm. The patent has been
upheld as granted except, with respect to certain claims, for minor amendments. In January 2008, ratiopharm and AstraZeneca filed notices of
appeal against this decision.
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The ’940 patent for Nexium covers a process for the manufacturing of esomeprazole and its salts in Austria, Belgium, Switzerland, Germany,
Denmark, Spain, France, UK, Greece, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Monaco, The Netherlands, Portugal, Slovenia
and Sweden. This positive decision by the EPO means that this patent, in its amended form, still covers the manufacturing process for Nexium.
This patent expires in 2015.
This portfolio includes additional patents with expiration dates ranging from 2009 to 2018. In addition to these patents, Nexium has data
exclusivity valid until March 2010 in most major European markets.
AstraZeneca has full confidence in, and will vigorously defend and enforce, its intellectual property rights protecting Nexium.
Patent litigation
In October 2005, AstraZeneca received a Paragraph IV Certification notice-letter from Ranbaxy Pharmaceuticals, Inc. that Ranbaxy
Laboratories Limited (together Ranbaxy) had submitted an ANDA to the FDA for 20mg and 40mg esomeprazole magnesium delayed-release
capsules. The ANDA alleged invalidity and/or non-infringement in respect of certain AstraZeneca US patents listed in the FDA Orange Book
with reference to Nexium. In November 2005, AstraZeneca commenced wilful patent infringement litigation in the US District Court for the
District of New Jersey against Ranbaxy and its affiliates in response to Ranbaxy’s Paragraph IV Certifications regarding Nexium. In April 2008,
AstraZeneca entered into a settlement agreement and consent judgment with Ranbaxy. Ranbaxy was the first to file an ANDA having a
Paragraph IV Certification notice in respect of the FDA Orange Book-listed Nexium patents. Ranbaxy conceded that all six patents asserted
by AstraZeneca in the patent litigation are valid and enforceable. Ranbaxy also conceded that four of the patents would be infringed by the
unlicensed sale of Ranbaxy’s proposed generic product. The settlement agreement allows Ranbaxy to commence sales of a generic version
of Nexium under a license from AstraZeneca on 27 May 2014.
In January 2006, AstraZeneca received a Paragraph IV Certification notice-letter from IVAX Pharmaceuticals Inc. that IVAX Corporation
(together IVAX) had submitted an ANDA to the FDA for 20mg and 40mg esomeprazole magnesium delayed-release capsules. The ANDA
contained Paragraph IV Certifications of invalidity and/or non-infringement in respect of certain AstraZeneca US patents listed in the FDA
Orange Book with reference to Nexium. In March 2006, AstraZeneca commenced wilful patent infringement litigation in the US District Court
for the District of New Jersey against IVAX, its parent Teva Pharmaceuticals, and their affiliates. In December 2008, the Court granted
AstraZeneca’s motion to add Cipla, Ltd. as a defendant in the litigation. No trial date has been set.
In August 2006, AstraZeneca received a Paragraph IV Certification notice-letter from Dr Reddy’s Laboratories Inc. and Dr Reddy’s Laboratories
Limited (together Dr Reddy’s) that Dr Reddy’s had submitted an ANDA to the FDA for 20mg and 40mg esomeprazole magnesium delayed-
release capsules. Dr Reddy’s August 2006 notice did not challenge three FDA Orange Book-listed patents claiming esomeprazole magnesium
(US Patent Nos. 5,714,504, 5,877,192 and 6,875,872). In December 2007, AstraZeneca received another Paragraph IV Certification notice-
letter from Dr. Reddy’s that Dr. Reddy’s had submitted an ANDA to the FDA for 20mg and 40mg esomeprazole magnesium delayed-release
capsules. Unlike the August 2006 notice, Dr. Reddy’s December 2007 notice alleged that US Patent Nos. 5,714,504, 5,877,192 and
6,875,872 were invalid or not infringed. AstraZeneca’s exclusivity relating to these three patents expires on 3 August 2015, 27 November 2014
and 27 November 2014, respectively. In January 2008, AstraZeneca commenced patent infringement litigation in the US District Court for the
District of New Jersey against Dr. Reddy’s. No trial date has been set.
In July and September 2007, AstraZeneca received a Paragraph IV Certification notice-letter from Matrix Laboratories, Inc. (Matrix) that Matrix
had submitted an ANDA to the FDA for 20mg and 40mg esomeprazole magnesium delayed-release capsules. Matrix was seeking FDA
approval to market a generic esomeprazole magnesium product prior to the expiration of some but not all of the patents listed in the FDA
Orange Book with reference to Nexium. Matrix’s notice did not challenge three FDA Orange Book-listed patents claiming esomeprazole
magnesium (US Patent Nos. 5,714,504, 5,877,192 and 6,875,872). As AstraZeneca has not received notice from Matrix as to these three US
patents, Matrix cannot market generic esomeprazole magnesium until the end of the exclusivity afforded by these patents. AstraZeneca did not
bring a lawsuit. AstraZeneca reserves the right to enforce all patents related to Nexium, including those listed in the FDA Orange Book.
In March 2008, AstraZeneca received a Paragraph IV Certification notice-letter from Teva Parental Medicines (Teva) that Teva had submitted
a new drug application (NDA) to the FDA regarding esomeprazole for injection, 20mg/vial and 40mg/vial. The notice contains certifications
of invalidity, unenforceability, and/or non-infringement in respect of US Patent No. 5,877,192, which is listed in the FDA Orange Book with
reference to Nexium in intravenous form. In April 2008, AstraZeneca commenced patent infringement litigation against Teva in the US District
Court for the District of New Jersey. In October 2008, Teva informed AstraZeneca that Teva was withdrawing its NDA relating to esomeprazole
for injection. As a result of Teva withdrawing its NDA, the Court has dismissed the litigation.
In May and June 2008, AstraZeneca received a complaint from IVAX and a complaint from Dr. Reddy’s for declaratory judgments of non-
infringement and/or invalidity for patents listed in the FDA Orange Book with reference to Nexium that were not previously at issue in the
ongoing infringement litigations. In August 2008, the Court dismissed the IVAX and Dr. Reddys declaratory judgment actions as to certain
patents and stayed the declaratory judgment actions as to remaining patents at issue. In January 2009, the Court vacated its August 2008
Orders, which had dismissed and stayed the declaratory judgment actions. As a result, the IVAX and Dr. Reddy’s declaratory judgment actions
are proceeding. No trial date has been set.
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In August 2008, AstraZeneca received a Paragraph IV Certification notice-letter from IVAX challenging US Patent No. 7,411,070 (the ’070 patent).
The ’070 patent is listed in the FDA Orange Book with reference to Nexium. The notice contains certifications of invalidity, unenforceability and/
or non-infringement in respect of the ’070 patent. In October 2008, AstraZeneca commenced patent infringement litigation asserting the
’070 patent against IVAX and Cipla Limited in the US District Court, District of New Jersey. No trial date has been set.
In December 2008, AstraZeneca received a Paragraph IV Certification notice-letter from Sandoz, Inc. (Sandoz) that Sandoz had submitted
an ANDA to the FDA for esomeprazole magnesium delayed-release capsules, 20mg and 40mg. The ANDA alleged invalidity and/or non-
infringement in respect of certain AstraZeneca US patents listed in the FDA Orange Book with reference to Nexium. In January 2009,
AstraZeneca commenced patent infringement litigation in the US District Court for the District of New Jersey against Sandoz in response
to Sandoz’s Paragraph IV Certifications regarding Nexium. No trial date has been set.
In Canada, AstraZeneca Canada Inc. received several notices of allegation from Apotex Inc. (Apotex) in late 2007 in respect of patents listed on
the Patent Register in Canada for Nexium. Apotex has asserted in its notices that it has filed an Abbreviated New Drug Submission for 20mg
and 40mg esomeprazole magnesium trihydrate tablets and alleges non-infringement and/or invalidity of numerous patents. AstraZeneca
responded by commencing seven court applications in January 2008 under the Patented Medicines (Notice of Compliance) Regulations.
In January 2008, Apotex advised that its product was erroneously described as being a trihydrate in its recent allegations, which Apotex
asserted it was withdrawing. Apotex made replacement allegations in January 2008, some of which AstraZeneca is continuing to challenge
in Court applications commenced in March 2008 under the Patented Medicines (Notice of Compliance) Regulations. Apotex cannot obtain
a Notice of Compliance (marketing approval) for its esomeprazole tablets until the earlier of the disposition of all of the court applications in
Apotex’s favour or, unless a Prohibition Order is granted, 24 months from the date on which the latest court application has been commenced.
In Norway, AstraZeneca received a writ from Hexal AG, Sandoz AS (Norway) and Sandoz A/S (Denmark) (together Hexal) claiming that
AstraZeneca’s Norwegian patents No. 314,125 and No. 307,378, which relate to Nexium, are invalid. In a reply filed with the Oslo District Court
in September 2008, AstraZeneca stated that it contests Hexal’s claims. AstraZeneca filed a request with the Norwegian Patent Office to amend
Norwegian patent No. 314,125 and also requested that the Court stay the invalidity case pending determination of the patent amendment request.
In October 2008, Hexal consented to AstraZeneca’s request to stay the invalidity case until the patent amendment request had been determined.
In Finland, AstraZeneca filed for declaratory relief against Sandoz A/S and Sandoz Oy (Finland) (together Sandoz) in July 2008 in respect of
Finnish Patent No. 117,755 (the ’755 patent), which relates to Nexium. AstraZeneca has requested that the Finnish Court declare that Sandoz
would infringe the ’755 patent if they were to launch a generic esomeprazole product prior to expiry of the term of the ’755 patent. Sandoz filed
a written response in November 2008 and requested, inter alia, that this proceeding be stayed. In September 2008, Sandoz and Hexal brought
an invalidity action concerning the ’755 patent before the District Court of Helsinki. AstraZeneca filed a written response to the invalidity action
in December 2008. No trial date has been set for either of these two Finnish Court proceedings.
AstraZeneca has full confidence in, and will vigorously defend and enforce, its intellectual property protecting Nexium.
Federal Trade Commission (FTC) inquiry
In July 2008, AstraZeneca received a Civil Investigative Demand from the Federal Trade Commission seeking information regarding the Nexium
patent litigation settlement with Ranbaxy. AstraZeneca is co-operating fully with the request.
PulmIcort resPules (budESoNIdE INhAlATIoN SuSpENSIoN)
On 25 November 2008, AstraZeneca entered into a settlement agreement in its Pulmicort Respules patent infringement litigation against IVAX
Pharmaceuticals, Inc., a wholly owned subsidiary of Teva Pharmaceuticals USA Inc. (Teva).
The agreement settles the patent infringement litigation filed by AstraZeneca following Teva’s submission to the FDA of an ANDA for a generic
version of Pulmicort Respules. Under the settlement agreement, Teva concedes that the patents asserted by AstraZeneca in the patent
litigation are valid and enforceable. Teva also concedes that its generic version of Pulmicort Respules infringes AstraZeneca’s patents.
The settlement agreement will allow Teva to commence sales of budesonide inhalation suspension, a generic version of Pulmicort Respules,
under an exclusive licence from AstraZeneca beginning 15 December 2009. AstraZeneca will receive a significant royalty on sales of Teva’s
product, with a marked step down in payments if additional at-risk generic products enter the market place. Teva also agrees to pay
AstraZeneca a sum in respect of damages resulting from the unauthorised launch of its generic budesonide inhalation suspension product in
November 2008. The agreement releases Teva from all past US sales of its generic budesonide inhalation suspension and provides that any
product already shipped by Teva will remain in the market to be further distributed and dispensed.
In March 2008, AstraZeneca filed a lawsuit in the US District Court for the District of New Jersey against Breath Ltd. (Breath) for patent
infringement. The lawsuit is the result of an ANDA filed by Breath with the FDA concerning Breath’s intent to market a generic version of
AstraZeneca’s Pulmicort Respules in the US prior to the expiration of AstraZeneca’s patents. The basis for AstraZeneca’s complaint is that
the action by Breath of filing an ANDA infringes certain of AstraZeneca’s patents directed to Pulmicort Respules and their use. In May 2008,
Breath responded and filed counterclaims alleging non-infringement and invalidity. Discovery in the litigation is ongoing.
AstraZeneca has full confidence in, and will vigorously defend and enforce, its intellectual property protecting Pulmicort Respules.
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seroquel (quETIApINE FumARATE)
Product liability
In August 2003, Susan Zehel-Miller filed a putative class action against AstraZeneca PLC and AstraZeneca Pharmaceuticals LP on behalf of
‘all persons in the US who purchased and/or used Seroquel’. Among other things, the class action alleged that AstraZeneca failed to provide
adequate warnings in connection with an alleged association between Seroquel and the onset of diabetes. In 2004, the US District Court for
the Middle District of Florida denied class certification and the case was ultimately dismissed. Two additional putative class actions raising
similar allegations have likewise been dismissed. There are no other US class actions relating to Seroquel; however, four putative class actions
raising substantially similar allegations have been filed in Canada.
AstraZeneca Pharmaceuticals LP, either alone or in conjunction with one or more affiliates, has been sued in numerous individual personal
injury actions involving Seroquel. In most of these cases, the nature of the plaintiffs’ alleged injuries is not clear from the complaint and, in most
cases, little or no factual information regarding the alleged injury has been provided in the complaint. However, the plaintiffs generally contend
that they developed diabetes and/or other related injuries as a result of taking Seroquel and/or other atypical anti-psychotic medications.
As of 5 January 2009, AstraZeneca was defending approximately 9,210 served or answered lawsuits involving approximately 15,461 plaintiff
groups. To date, approximately 2,363 additional cases have been dismissed by order or agreement and approximately 1,500 of those cases
have been dismissed with prejudice. Approximately 60% of the plaintiffs’ currently pending Seroquel claims are in state courts (primarily
Delaware, New Jersey, New York and Missouri) with the other 40% pending in the federal court, where most of the cases have been
consolidated for pre-trial purposes into a Multi-District Litigation (MDL). Approximately 24% of the cases that were or are pending in the federal
court MDL have been dismissed.
Plaintiffs’ discovery of AstraZeneca has largely been completed, although additional discovery may take place. AstraZeneca’s discovery of
specific plaintiffs’ cases is ongoing in most jurisdictions and AstraZeneca intends to vigorously test the merits of those individual cases on
factual and legal grounds. Bellwether case systems have been implemented by the courts in Delaware, New Jersey and the federal MDL court
due to the larger volume of consolidated cases in those jurisdictions.
On 28 January 2009, the federal judge presiding over the Seroquel MDL in the District Court for the Middle District of Florida orally informed the
parties that she was granting AstraZeneca’s motions for summary judgment in the first two Seroquel product liability cases set for trial.
Therefore, the trial scheduled for 2 February 2009 in Florida has been cancelled.
AstraZeneca expects that an additional seven to nine trials may be scheduled to commence in 2009. AstraZeneca is also aware of approximately
59 additional cases that have been filed but not yet served and has not determined how many additional cases, if any, may have been filed.
Some of the cases also include claims against other pharmaceutical manufacturers such as Eli Lilly & Co., Janssen Pharmaceutica, Inc. and/or
Bristol-Myers Squibb Company. AstraZeneca intends to litigate these cases on their individual merits and will defend against the cases vigorously.
As of 31 December 2008, legal defence costs of approximately $512m have been incurred (of which approximately $335m was incurred
during 2008). AstraZeneca has product liability insurance that is considered to respond to the vast majority of claims brought in these Seroquel
cases, subject to a retention. This insurance provides coverage for legal defence costs and potential damage amounts in connection with the
Seroquel product liability cases. AstraZeneca has recorded an insurance receivable of $426m at 31 December 2008 (2007: $139m).
AstraZeneca currently estimates that its defence costs alone may exceed its insurance coverage with respect to the Seroquel cases.
Patent litigation – Seroquel
In September 2005, AstraZeneca received a notice from Teva Pharmaceuticals USA Inc. (Teva) that Teva had submitted an ANDA for
quetiapine fumarate 25mg tablets containing a Paragraph IV Certification alleging invalidity, unenforceability or non-infringement in respect of
AstraZeneca’s US patent listed in the FDA Orange Book with reference to Seroquel. In November 2005, AstraZeneca filed a lawsuit directed
to Teva’s 25mg tablets ANDA in the US District Court for the District of New Jersey for wilful patent infringement.
In February 2006, AstraZeneca received another notice from Teva that it had amended its previously submitted ANDA for quetiapine fumarate
25mg tablets and added 100mg, 200mg and 300mg tablets to its application to the FDA. The amended ANDA submission contained a similar
Paragraph IV Certification alleging invalidity, unenforceability or non-infringement in respect of AstraZeneca’s US patent listed in the FDA Orange
Book with reference to Seroquel. In March 2006, in response to Teva’s amended ANDA and Teva’s intent to market additional strengths of a
generic version of Seroquel in the US prior to the expiration of AstraZeneca’s patent, AstraZeneca filed an additional lawsuit against Teva in the
US District Court for the District of New Jersey for patent infringement.
The two Teva lawsuits were consolidated in April 2006. However, in March 2006, the US District Court had granted Teva’s motion to strike
AstraZeneca’s added allegation of wilfullness in its patent infringement claim in the first complaint directed to Teva’s 25mg tablets. Therefore,
in the consolidated action, in response to AstraZeneca’s now combined allegations of patent infringement directed to Teva’s 25mg, 100mg,
200mg and 300mg tablets ANDA, Teva alleges non-infringement and patent invalidity. In January 2007, Teva filed a motion seeking leave to
amend its pleadings in the consolidated action to add allegations, defences and counter-claims directed to alleged inequitable conduct in the
procurement of AstraZeneca’s patent.
In March 2007, AstraZeneca received a Paragraph IV Certification notice-letter from another generic drug manufacturer, Sandoz Inc. (Sandoz),
notifying AstraZeneca that it had submitted an ANDA to the FDA for approval to market a generic version of AstraZeneca’s 25mg quetiapine
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fumarate tablets prior to the expiration of AstraZeneca’s listed patent. Sandoz’s notice-letter alleged non-infringement and patent invalidity. In April
2007, AstraZeneca filed a lawsuit in the US District Court for the District of New Jersey against Sandoz alleging patent infringement.
In June 2007, AstraZeneca received a third notice from Teva notifying AstraZeneca that it had supplemented its ANDA for quetiapine fumarate
tablets again, adding 50mg, 150mg and 400mg tablets to the application. The third notice-letter similarly advised that Teva’s supplementation
contained a Paragraph IV Certification respecting AstraZeneca’s listed patent covering Seroquel. In June 2007, AstraZeneca filed a third lawsuit
in the US District Court for the District of New Jersey against Teva for its supplementation adding the 50mg, 150mg and 400mg dosage strengths.
In October 2007, the Court granted AstraZeneca’s partial summary judgment motion based on collateral estoppel, which precludes Teva from
re-litigating issues previously resolved against it in another previous patent litigation involving Eli Lilly & Co.’s anti-psychotic drug, Zyprexa
.
After completion of fact-discovery, Sandoz and Teva conceded that their respective ANDA products infringe AstraZeneca’s patent covering
Seroquel. Sandoz and Teva also conceded the patent’s validity, leaving only allegations of unenforceability for inequitable conduct. In March
2008, AstraZeneca filed a motion for summary judgment of no inequitable conduct.
In July 2008, the US District Court, District of New Jersey granted AstraZeneca’s motion for summary judgment of no inequitable conduct.
Therefore, on 9 July 2008, the Court entered its Final Judgment in AstraZeneca’s favour on all claims and defences in respect of infringement,
validity, and enforceability of AstraZeneca’s patent. The Court’s judgment includes an order to the FDA that any approvals of Teva’s or Sandoz’s
ANDAs shall be after the date that is the later of the expiration date of US Patent No. 4,879,288 (the ’288 patent) or the expiration date of any
additional exclusivity to which AstraZeneca is or becomes entitled.
Teva and Sandoz appealed the judgment to the Federal Circuit Court of Appeals. In December 2008, the parties completed briefing. Oral
argument is scheduled for 6 March 2009. In December 2008, Teva announced that the FDA had tentatively approved its generic quetiapine tablets.
Patent litigation – Seroquel XR
AstraZeneca lists two patents in the FDA Orange Book referencing Seroquel XR: the ’288 patent covering quetiapine fumarate, the active
ingredient, and US Patent No. 5,948,437 (the ’437 patent) covering extended-release formulations, processes and methods in respect of
quetiapine fumarate.
In July 2008, AstraZeneca received a Paragraph IV Certification notice-letter from Handa Pharmaceuticals, LLC (Handa) stating that it had
submitted an ANDA seeking approval to market generic versions of 200mg and 300mg Seroquel XR tablets before the expiration of AstraZeneca’s
two listed patents covering Seroquel XR. Handa’s Certification notice-letter alleged non-infringement, invalidity and unenforceability. Later in July
2008, AstraZeneca received a similar Paragraph IV Certification notice-letter from Handa stating that it had submitted an amendment to its ANDA
for 200mg and 300mg tablets adding a request for approval to market a generic version of 400mg Seroquel XR tablets before the expiration of
AstraZeneca’s two listed patents covering Seroquel XR.
In July 2008, AstraZeneca filed a lawsuit in US District Court, District of New Jersey, against Handa and a currently unknown, associated entity
alleging infringement of AstraZeneca’s ’288 and ’437 patents covering Seroquel XR 200mg, 300mg and 400mg tablets. The filing of this lawsuit
triggered 30-month stays of FDA final approval for Handa’s ANDA products.
In September 2008, AstraZeneca received a Paragraph IV Certification notice-letter from Accord Healthcare Inc. (Accord) advising that it had
submitted an ANDA seeking approval to market generic versions of 200mg, 300mg and 400mg Seroquel XR tablets before expiration of
AstraZeneca’s patent covering the Seroquel XR formulation. Accord is a subsidiary of Intas Pharmaceutical Limited (Intas). Later in September
2008, AstraZeneca filed a lawsuit in US District Court, District of New Jersey, against Accord, Intas and related entities, alleging infringement of
the ’437 patent. The filing of this lawsuit triggered a 30-month stay of FDA final approval for Accord’s ANDA products.
In October and November 2008, AstraZeneca received respectively a third and fourth Paragraph IV Certification notice-letter from Handa
advising that it had submitted an ANDA seeking approval to market generic versions of 50mg and 150mg Seroquel XR tablets before expiration
of AstraZeneca’s patents covering the product. In October 2008, AstraZeneca filed a second lawsuit in US District Court, District of New Jersey
against Handa alleging infringement of AstraZeneca’s patents covering the active ingredient and formulation of Seroquel XR 50mg tablets; and
in December 2008, AstraZeneca filed a third lawsuit against Handa alleging infringement of AstraZeneca’s patents covering the active
ingredient and formulation of Seroquel XR 150mg tablets. The filing of these additional lawsuits triggered 30-month stays of FDA final approval
for Handa’s 50mg and 150mg ANDA products.
For purposes of discovery, the three Handa actions and the Accord action have been consolidated under a common scheduling order.
The consolidated matter proceeds.
In December 2008, AstraZeneca received a Paragraph IV Certification notice-letter from Biovail Laboratories International SRL (Biovail) stating
that it had submitted an ANDA seeking approval to market generic versions of 200mg, 300mg and 400mg Seroquel XR tablets before the
expiration of AstraZeneca’s two listed patents covering Seroquel XR. Biovail’s Certification notice-letter alleged non-infringement and invalidity
in respect of AstraZeneca’s patents. In January 2009, AstraZeneca filed a lawsuit in US District Court, District of New Jersey, against Biovail
alleging infringement of AstraZeneca’s ’288 and ’437 patents covering Seroquel XR 200mg, 300mg and 400mg tablets. The filing of this lawsuit
triggered a 30-month stay of FDA final approval for Biovail’s ANDA products.
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On 26 January 2009, AstraZeneca received a second Paragraph IV Certification notice-letter from Accord stating that it had submitted an
ANDA seeking approval to market a generic version of 150mg Seroquel XR tablets before the expiration of AstraZeneca’s patent covering
the Seroquel XR formulation. Accord’s Certification notice-letter alleged non-infringement and invalidity in respect of AstraZeneca’s patents.
AstraZeneca has full confidence in, and will vigorously defend and enforce, its intellectual property protecting Seroquel and Seroquel XR.
Sales and marketing practices
The US Attorney’s Office in Philadelphia is directing an investigation relating to Seroquel involving a review of sales and marketing practices,
including allegations that AstraZeneca promoted Seroquel for non-indicated (off-label) uses. AstraZeneca understands that this investigation
is the subject of a sealed qui tam lawsuit filed under the False Claims Act. A second investigation may relate to selected physicians who
participated in clinical trials involving Seroquel. There are also a number of additional active investigations involving Seroquel sales and
marketing practices led by state Attorneys General which include investigations relating to Seroquel off-label issues. Approximately 34 states
are participating in a joint investigation and several states may also have individual investigations. It is not possible to predict the outcome of
any of these investigations, which could include the payment of damages and the imposition of fines, penalties and administrative remedies.
In February 2007, the Commonwealth of Pennsylvania filed suit against AstraZeneca, Eli Lilly & Co. (Lilly), and Janssen Pharmaceutica Inc.
(Janssen) claiming damages incurred by the Commonwealth as a result of alleged off-label promotion of atypical anti-psychotics by the three
manufacturers. The lawsuit is filed in state court in Philadelphia and seeks to recover the cost to the Pennsylvania Medicaid programme and
other state-funded health insurance programmes for prescriptions written as a result of the alleged off-label promotion and also seeks
compensation for costs incurred by the State for the treatment of Medicaid and other public assistance beneficiaries who allegedly developed
diabetes, hyperglycemia and other conditions as a result of using Seroquel without adequate warning. In December 2007, the Court granted
the defendants’ motion to sever the claims against AstraZeneca and Janssen from those against Lilly and directed the Commonwealth to file
separate complaints against the two severed defendants, which the Commonwealth did in January 2008. In December 2008, the Court
granted AstraZeneca’s motion to dismiss all but two counts of the Complaint including dismissal of the Commonwealth’s claims alleging
violations of the Pennsylvania Medicaid False Claims Act. Similar lawsuits were filed by the State of Montana in February 2008, the State of
Arkansas in May 2008, and the State of South Carolina in January 2009. AstraZeneca believes these claims to be without merit and intends
to vigorously defend against them. As of the date of this announcement, the Montana action has not been served.
In May 2007, the New Jersey Ironworkers Local Union No. 68 filed a class action suit against AstraZeneca on behalf of all individuals and
non-governmental entities that paid for Seroquel from January 2000 to date. The lawsuit was filed in the federal District Court in New Jersey
and alleged that AstraZeneca promoted Seroquel for off-label uses and misled class members into believing that Seroquel was superior to
other, lower-cost alternative medicines. Two similar class action lawsuits were filed in June and July 2007 in the New Jersey and Pennsylvania
federal courts. In December 2007, the three lawsuits were transferred to the Middle District of Florida by the US Judicial Panel on Multi-District
Litigation (MDL). In November 2008, the MDL Court granted AstraZeneca’s motion and dismissed these cases in their entirety with prejudice. The
plaintiffs filed a Notice of Appeal in December 2008. AstraZeneca intends to vigorously defend against the appeal, which it expects will be heard
by the Eleventh Circuit Court of Appeals some time in 2009.
In September 2008, the Pennsylvania Employees Benefit Trust Fund (PEBTF) served AstraZeneca Pharmaceuticals LP with a complaint filed
in the Pennsylvania Court of Common Pleas of Philadelphia County seeking economic damages stemming from allegedly improper marketing
practices that caused the PEBTF to reimburse for allegedly overpriced Seroquel prescription and the medical care of Fund members allegedly
injured from Seroquel use. In October 2008, AstraZeneca removed this lawsuit to federal court and immediately requested that it be transferred
to the Seroquel MDL. The decision regarding transfer is pending. AstraZeneca intends to vigorously defend itself against this lawsuit.
In addition, there have been congressional inquiries regarding Seroquel as discussed below.
symbIcort (budESoNIdE/FoRmoTERol)
In May 2008, following an appeal by the generic manufacturers Norton Healthcare (Norton) and Generics UK, the European Patent Office (EPO)
Technical Board of Appeal revoked the European patent EPB 1,014,993 covering the use of Symbicort for the treatment of chronic obstructive
pulmonary disease (COPD). The stays granted in the revocation proceedings instituted by IVAX Pharmaceuticals (UK) Limited (IVAX) in the UK
and Ireland with respect to the national parts of the Symbicort combination patent EPB 613,371 and EPB 1,014,993 will remain in place until
IVAX applies to the Court to lift these stays in light of the EPO decisions.
In December 2008, following an opposition by Norton, the EPO Opposition Division revoked the European patent EPB 1,210,943 covering the
use of Symbicort, with a specific ratio of the active ingredients and a specific particle size, for the treatment of COPD.
In June 2008, the US Patent and Trademark Office issued a final determination that US Patent No. 5,674,860 was not eligible for patent term
extension. AstraZeneca filed a request for reconsideration.
AstraZeneca will vigorously defend and enforce its remaining intellectual property portfolio protecting Symbicort, which has patent expiry dates
up to 2019 in Europe.
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synAgIs (pAlIvIZumAb)
MedImmune settled its patent litigation in June 2008 with Genentech and the City of Hope in respect of the Cabilly patent (US Patent No.
6,331,415). Under the terms of the settlement agreement, the litigation, which was pending before the US District Court for the Central District
of California, was fully resolved and dismissed. The settlement resolved disputed issues with respect to Synagis as well as a related product,
motavizumab, for which regulatory approval is being sought. The settlement also permits MedImmune to obtain licences for certain additional
pipeline products under the Cabilly patent family. MedImmune filed its original complaint in April 2003. Following a US Supreme Court decision
in MedImmune’s favour in January 2007, the case had been returned to the lower courts for further proceedings.
toProl-xl (mETopRolol SuCCINATE)
In 2003, AstraZeneca filed a patent infringement action against KV Pharmaceutical Company (KV) in the US District Court for the Eastern District
of Missouri in response to KV’s notification of its intention to market a generic version of Toprol-XL tablets in the 200mg dose prior to the expiration
of AstraZeneca’s patents covering the substance and its formulation. In response to later similar notices from KV related to the 25mg, 50mg and
100mg doses, AstraZeneca filed further actions. KV responded in each instance and filed counterclaims alleging non-infringement, invalidity
and unenforceability of the listed patents.
In 2004, AstraZeneca filed a patent infringement action against Andrx Pharmaceuticals LLC (Andrx) in the US District Court for the District
of Delaware in response to Andrx’s notification of its intention to market a generic version of Toprol-XL tablets in the 50mg dose prior to the
expiration of AstraZeneca’s patents. In response to two later similar notices from Andrx related to the 25mg, 100mg and 200mg doses,
AstraZeneca filed two additional patent infringement actions in the same court. In each instance, Andrx claimed that each of the listed patents
is invalid, not infringed and unenforceable.
In 2004, AstraZeneca filed a patent infringement action against Eon Labs Manufacturing Inc., which was later acquired by Sandoz Inc. (Sandoz),
in the US District Court for the District of Delaware in response to Sandoz’s notification of its intention to market generic versions of Toprol-XL
tablets in the 25mg, 50mg, 100mg and 200mg doses prior to the expiration of AstraZeneca’s patents. In its response, Sandoz alleged that each
of the listed patents is invalid, not infringed and unenforceable. Sandoz also alleged that the filing of the infringement complaints, as well as other
actions by AstraZeneca, constitutes anti-competitive conduct in violation of US anti-trust laws. Pursuant to a joint motion of AstraZeneca and
Sandoz, these anti-trust claims were severed from the case and stayed, for possible consideration depending on the outcome of the trial of the
patent claims.
All of the patent litigation relating to Toprol-XL against KV, Andrx and Sandoz was consolidated for pre-trial discovery purposes and motion practice
in the US District Court for the Eastern District of Missouri. The defendants filed a motion for summary judgment in 2004 alleging that the Toprol-XL
patents were invalid due to double patenting. A summary judgment motion of unenforceability was filed by the defendants in 2005 and AstraZeneca
filed summary judgment motions on infringement and validity in 2005. In January 2006, the US District Court for the Eastern District of Missouri
issued a ruling finding that the two patents-in-suit were unenforceable and invalid. AstraZeneca appealed the District Court decision to the US
Court of Appeals for the Federal Circuit. In July 2007, a three-judge panel of the Federal Circuit unanimously ruled that the inequitable conduct
determination by the District Court was improper and therefore the issue of inequitable conduct was remanded to the District Court. The panel
upheld, however, in a divided decision, the finding that the Toprol-XL patents were invalid due to double patenting. In August 2007, AstraZeneca
petitioned the Federal Circuit for reconsideration of the invalidity determination. Reconsideration was denied in October 2007. In the second and
third quarters of 2008, the remaining issues before the District Court were settled with all three defendants for amounts not material to AstraZeneca.
In the first quarter of 2006, AstraZeneca was served with 14 complaints filed in the US District Courts in Delaware, Massachusetts and Florida
against AstraZeneca Pharmaceuticals LP, AstraZeneca LP, AstraZeneca AB and Aktiebolaget Hässle. The complaints were putative class actions
filed on behalf of both direct purchasers and indirect purchasers that allege that the AstraZeneca defendants attempted to illegally maintain
monopoly power in the US over Toprol-XL in violation of the Sherman Act through the listing of invalid and unenforceable patents in the FDA
Orange Book and the enforcement of such patents through litigation against generic manufacturers seeking to market metoprolol succinate.
The complaints seek treble damages based on alleged overcharges to the putative classes of plaintiffs. These 14 complaints were consolidated
into two amended complaints in the US District Court in Delaware, one on behalf of direct purchasers, and one on behalf of indirect purchasers.
The lawsuits are based upon the 2006 ruling described above by the US District Court for the Eastern District of Missouri in the consolidated
patent litigation against KV, Andrx and Sandoz, that the AstraZeneca patents relating to Toprol-XL are invalid and unenforceable. In 2006
AstraZeneca filed a motion seeking to dismiss or, in the alternative, stay the consolidated complaint in both anti-trust cases. As noted above,
AstraZeneca appealed the District Court decision in the underlying patent litigation, which resulted in a reversal and remand on the issue of
inequitable conduct and affirmation that the Toprol-XL patents were invalid. AstraZeneca’s motion to dismiss the anti-trust complaints is still
pending. AstraZeneca denies the allegations of the anti-trust complaints and will vigorously defend the lawsuits.
ZestrIl (lISINopRIl)
In 1996, two of AstraZeneca’s predecessor companies, Zeneca Limited and Zeneca Pharma Inc. (as licensees), Merck & Co., Inc. and Merck Frosst
Canada Inc. (together Merck) commenced a patent infringement action in the Federal Court of Canada against Apotex Inc. (Apotex), alleging
infringement of Merck’s lisinopril patent. Apotex sold a generic version of AstraZeneca’s Zestril and Merck’s Prinivil
tablets. Apotex admitted
infringement but raised positive defences to infringement, including that it acquired certain quantities of lisinopril prior to issuance of the patent and
that certain quantities were licensed under a compulsory licence. Apotex also alleged invalidity of the patent. Following a trial in early 2006, in April 2006
the Federal Court of Canada ruled in favour of AstraZeneca and Merck on the key issues and Apotex stopped selling lisinopril in May 2006. In October
2006, the Federal Court of Appeal in Canada upheld the lower court’s decision and dismissed Apotex’s appeal. In December 2006, Apotex sought
leave to appeal to the Supreme Court of Canada. The Supreme Court of Canada dismissed Apotex’s leave to appeal in May 2007. AstraZeneca
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intends to pursue a reference proceeding in the Federal Court to quantify the damages related to the infringement by Apotex. Apotex re-
commenced the sale of lisinopril in October 2007 after expiry of the relevant patent.
AvERAgE wholESAlE pRICE lITIgATIoN
AstraZeneca is a defendant along with many other pharmaceutical manufacturers in several sets of cases involving allegations that defendants
caused entities to overpay for prescription drugs as a result of causing the publication of allegedly inflated wholesale list prices. The first set of
cases were filed in December 2001 in the US District Court in Boston, Massachusetts on behalf of a putative class of plaintiffs. Following the
Massachusetts complaint, nearly identical class action suits were filed in two other states, which have been consolidated with the Massachusetts
action for pre-trial purposes, pursuant to federal Multi-District Litigation (MDL) procedures. Second, AstraZeneca and other manufacturers
have since been sued in similar lawsuits filed by the State Attorneys General of Pennsylvania, Nevada, Montana, Wisconsin, Illinois, Alabama,
Kentucky, Arizona, Mississippi, Hawaii, Alaska, Idaho, Iowa and Utah as well as by multiple individual counties in the State of New York. The
Attorney General lawsuits seek to recover alleged overpayments under Medicaid and other state-funded healthcare programmes. In several
cases, the states are also suing to recover alleged overpayments by state residents. Several of these suits have also been consolidated with the
Massachusetts action for pre-trial purposes, pursuant to federal MDL procedures. Third, private insurers and consumers have filed putative
state-wide class actions in Arizona and New Jersey alleging damages relating to private reimbursement of prescription drugs.
In the MDL action in January 2006, the District Court certified three classes of plaintiffs against the ‘Track 1’ manufacturer defendants, AstraZeneca,
GlaxoSmithKline, Bristol-Myers Squibb, Schering-Plough and Johnson & Johnson. The three certified classes are: a nationwide class of
consumers who made co-payments for certain physician-administered drugs reimbursed under the Medicare Part B programme (Part B drugs)
(Class 1); a Massachusetts-only class of third party payers, including insurance companies, union health and welfare benefit plans, and
self-insured employers, who covered consumer co-payments for Part B drugs (Class 2); and a Massachusetts-only class of third party payers
and consumers who paid for Part B drugs outside of the Medicare programme (Class 3). For all classes, the only AstraZeneca drug at issue is
Zoladex (goserelin acetate implant).
In May 2007, the parties reached a proposed settlement agreement resolving the Class 1 claims. The settlement, which was approved by the
Court in December 2008, will involve payments of up to $24m to reimburse individual class members submitting claims, plus attorneys’ fees
of $8.58m. AstraZeneca has agreed that a portion of any unclaimed settlement amounts will be donated to charitable organisations funding
cancer patient care and research. Notice of the proposed settlement was mailed to potential class members in December 2007. A provision
of $27m was established in 2007. In January 2009, one of the class members filed a notice of appeal challenging the settlement.
In June 2007 and November 2007, the MDL Court issued decisions, after a bench trial, on liability and damages on Classes 2 and 3. The Court
found AstraZeneca liable under the Massachusetts consumer protection statute for engaging in unfair and deceptive conduct in connection
with the pricing of Zoladex during the period 1998 to 2003. The Court awarded double damages (with pre-judgment interest) of $5.5m for
Class 2, and single damages (with pre-judgment interest) of $7.4m for Class 3. AstraZeneca believes the decision to be in error and filed an appeal.
The US Court of Appeals for the First Circuit held oral argument on the appeal in November 2008.
The MDL Court’s award on Classes 2 and 3, if it survives appeal, relates to damages incurred by payers within the Commonwealth of
Massachusetts only. Plaintiffs filed a motion seeking certification of multi-state classes of third party payers in an effort to pursue similar claims for
damages under the consumer protection statutes of other states. In September 2008, the MDL Court granted, in part, the plaintiffs’ motion for
certification of multi-state versions of Class 2 and Class 3 relating to Zoladex. AstraZeneca believes the decision to be in error. In January 2009,
the Court granted AstraZeneca’s motion to stay the entry of the order pending its appeal of the Court’s award relating to Massachusetts payers.
The multiple Attorney General lawsuits pending against AstraZeneca and other manufacturers nationwide, which involve numerous drugs in
addition to Zoladex, remain pending against AstraZeneca.
The average wholesale price case filed by the Alabama Attorney General was tried in Circuit Court in Montgomery, Alabama in February 2008.
The trial resulted in a jury verdict against AstraZeneca on the State’s claims of fraudulent concealment and misrepresentation, and an award of
compensatory damages of $40m and punitive damages of $175m. In June 2008, the trial court held a hearing on AstraZeneca’s request for
post-trial relief and reduced the punitive damages award, as required by statute, to $120m. AstraZeneca has filed an appeal with the Alabama
Supreme Court. In December 2008, AstraZeneca filed its opening brief supporting its appeal. The appeal seeks to have the entire judgment
reversed or, in the alternative, a new trial.
Separately, MedImmune is also involved in various lawsuits brought by various states and counties in the US alleging manipulation of average
wholesale prices by several defendants, including MedImmune. The lawsuits were filed between 2003 and 2007 by Alabama, Mississippi, Iowa,
New York City, and by various New York counties. The status of the various lawsuits by various states and counties alleging manipulation of
average wholesale price by several defendants, including MedImmune, did not change materially during the financial year ended 31 December
2008 except that, in 2008, the State of Kansas filed a suit against a number of defendants, including MedImmune, in the District Court of
Wyandotte County, Kansas.
The allegations made in respect of the average wholesale price lawsuits described in this section are denied and will be vigorously defended.
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340b ClASS ACTIoN lITIgATIoN
In August 2005, AstraZeneca was named as a defendant, along with multiple other pharmaceutical manufacturers, in a class action suit filed by
the County of Santa Clara in California state court on behalf of similarly situated California counties and cities that allegedly overpaid for drugs
covered by the federal ‘340B’ programme. The 340B programme entitles hospitals and clinics that treat a substantial portion of uninsured
patients to preferential drug pricing for outpatient drugs.
The case was removed to federal court, the US District Court for the Northern District of California. In 2006, the US District Court dismissed
each of the allegations in Santa Clara County’s complaint. The County appealed the dismissal, and the US Court of Appeals for the Ninth
Circuit reversed the dismissal in August 2008, enabling the County to continue its suit under a third party beneficiary breach of contract theory.
Recently, two more Counties became plaintiffs, the County of Santa Cruz and the County of Riverside. In November 2008, the US District
Court granted a motion for protective order, thereby limiting the scope of discovery in the manufacturers’ favour; however, the US District Court
certified the issue for an immediate interlocutory appeal.
On all other issues not before the appellate court, discovery is currently proceeding before the US District Court and a trial date has been set
for February 2010. AstraZeneca intends to vigorously defend these claims.
dRug ImpoRTATIoN ANTI-TRuST lITIgATIoN
In August 2004, Californian retail pharmacy plaintiffs filed an action in the Superior Court of California alleging a conspiracy by AstraZeneca and
approximately 15 other pharmaceutical manufacturer defendants to set the price of drugs sold in California at or above the Canadian sales
price for those same drugs and otherwise restrict the importation of pharmaceuticals into the US. In July 2005, the Court overruled in part
and sustained in part, without leave to amend, the defendants’ motion to dismiss the plaintiffs’ third amended complaint in these proceedings.
The Court overruled the defendants’ motion in respect of conspiracy claims but sustained the motion in respect of the California Unfair Competition
Law claims. In December 2006, the Court granted the defendants’ motion for summary judgment and the case was subsequently dismissed.
Plaintiffs appealed that decision and the Court of Appeal of the State of California affirmed the lower Court’s decision. Plaintiffs have appealed
to the Supreme Court of California, which has decided to hear the appeal.
AstraZeneca denies the material allegations in the California action and is vigorously defending this matter.
pAIN pump lITIgATIoN
Starting in February 2008, AstraZeneca LP, AstraZeneca Pharmaceuticals LP, Zeneca Holdings Inc., and/or AstraZeneca PLC have been named
as defendants and served in approximately 41 lawsuits, involving approximately 48 plaintiffs, filed in various US jurisdictions, alleging injuries caused
by third party pain pumps. The complaints in these cases generally allege that the use of Marcaine, Sensorcaine, Xylocaine and/or Naropin, with
or without epinephrine, in pain pumps that were implanted into patients in connection with arthroscopic surgery, caused chrondrolysis. Other
named defendants in these cases are other manufacturers and distributors of bupivacaine and lidocaine and other pain medications, pain pump
manufacturers, and in some cases the surgeons. To date, 25 plaintiffs have dismissed their cases against the AstraZeneca defendants while the
case was in preliminary stages, and the AstraZeneca defendants have filed pending motions to dismiss several other cases. In addition, three
plaintiffs have voluntarily dismissed AstraZeneca PLC but have maintained their suits against other AstraZeneca defendants.
Rights to market Sensorcaine, Xylocaine and Naropin in the US were sold to Abraxis Bioscience Inc. (Abraxis) in June 2006 but many of these
lawsuits may be a retained liability under the terms of the Asset Purchase Agreement with Abraxis. To date, AstraZeneca has tendered six of
the active claims to Abraxis.
It was previously reported that plaintiffs moved to consolidate the federal pain pump cases under the Multi-District Litigation (MDL) process.
The Judicial Panel on MDL denied that motion in August 2008. Accordingly, the cases will continue as individual lawsuits.
AstraZeneca intends to vigorously defend these cases.
ANTI-TRuST
In July 2006, AstraZeneca Pharmaceuticals LP was named as a defendant, along with a number of other pharmaceutical manufacturers and
wholesalers, in a complaint filed by RxUSA Wholesale, Inc. (RxUSA) in the US District Court for the Eastern District of New York. The complaint
alleges that the defendants violated federal and state anti-trust laws by, amongst other things, allegedly refusing to deal with RxUSA and other
‘secondary wholesalers’ in the wholesale pharmaceutical industry. The plaintiff alleges a conspiracy among the manufacturers and seeks an
injunction and treble damages. AstraZeneca vigorously denies the allegations and in November 2006 filed a motion to dismiss the complaint.
The motion to dismiss is pending.
For a description of other anti-trust-related litigation involving AstraZeneca, see the subsections entitled Nexium (esomeprazole), Losec/Prilosec
(omeprazole), Nolvadex (tamoxifen) and Toprol-XL (metoprolol succinate) in this Note 25 to the Financial Statements.
In January 2008 AstraZeneca, together with several other companies, was the subject of an unannounced inspection simultaneous with the
launch by the EU Commission (Commission) of a Sectoral Inquiry (Inquiry) into the pharmaceutical industry. The Inquiry relates to the introduction
of innovative and generic medicines and covers commercial and other practices, including the use of patents. On 28 November 2008, the
Commission published its preliminary report. The report does not identify wrongdoing by any individual companies but is stated to provide a
factual basis for further consideration. The Commission has stated that it will commence individual investigations where there are indications
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that competition rules have been breached. The preliminary report focuses on a number of issues relating to competition in the EU, referring
to strategies which the Commission believes pharmaceutical companies use to block or delay generic entry. Such strategies include: patent
filings and enforcement; patent settlement agreements and other agreements; interventions before national regulatory authorities; and life-cycle
management strategies.
A final report is expected in Spring 2009. AstraZeneca has been co-operating fully with the Commission and participating in European
Federation for Pharmaceutical Industries and Associations activities.
FEdERAl TRAdE CommISSIoN (FTC) STudy oN AuThoRISEd gENERICS
In October 2007, AstraZeneca received a Special Order from the FTC, requesting certain information in connection with the FTC’s industry-wide
study of the short- and long-term competitive effects of authorised generics in the prescription drug marketplace. AstraZeneca completed and
submitted its response to the FTC in January 2008.
AddITIoNAl govERNmENT INvESTIgATIoNS INTo dRug mARkETINg pRACTICES
As is true for most, if not all, major prescription pharmaceutical companies operating in the US, AstraZeneca is currently involved in multiple US
federal and state investigations into drug marketing and pricing practices. In addition to the investigations described above, the US Attorney’s
Office (USAO) in Philadelphia is directing two investigations which involve requests for documents and information relating to contracting and
disease management programmes with two of the leading national Pharmacy Benefits Managers. AstraZeneca has been co-operating with
these investigations and the USAO may decline to intervene in one or both of these investigations. The USAO in Boston is conducting an
additional investigation with a leading provider of pharmacy services to long-term care facilities. According to a securities filing, that investigation
may be the subject of one or more qui tam complaints that were filed under the False Claims Act.
In addition to the Attorney General investigations regarding Seroquel described above, the Delaware Attorney General’s Office is investigating
certain sales and marketing practices of AstraZeneca, which appear to focus on AstraZeneca’s prior interactions with physicians in the State of
Delaware. In addition, AstraZeneca is providing information in response to two informal requests for information relating to nominal pricing
under the Medicaid rebate program, one from the US Department of Justice and one from the Attorney General of the State of Michigan.
It is not possible to predict the outcome of any of these investigations, which could include the payment of damages and the imposition of
fines, penalties and administrative remedies.
SERIouS FRAud oFFICE (SFo) INquIRy
In 2007, AstraZeneca received from the SFO in the UK a request for documentation about its involvement in the UN Oil for Food programme in
Iraq. AstraZeneca denies any allegation of illegal or unethical behaviour in its trading relationships with Iraq. AstraZeneca has complied with the
SFO’s original request for documentation and with further requests for information received during the course of 2008. It is not currently
possible to predict the outcome of this inquiry.
oThER govERNmENT INvESTIgATIoNS
From time to time, AstraZeneca receives enquiries and requests for information from a number of governmental and/or other regulatory bodies
relating to a range of issues (some, but not all, of which may relate directly to the business of AstraZeneca) and some of which are confidential
in nature. AstraZeneca seeks to comply with these requests in an appropriate and timely manner and generally on the basis of legal advice
received. The nature and scope of the investigation in relation to which such enquiries and requests for information have been received is not
always known to AstraZeneca. Consequently, it is not always possible to determine whether such enquiries and investigations relate specifically
to AstraZeneca or are merely a means of gathering factual information in the context of an unrelated third-party issue.
CoNgRESSIoNAl INvESTIgATIoNS
Since March 2007 AstraZeneca, along with several other manufacturers, has received several letters from the Committee on Oversight and
Government Reform of the US House of Representatives as part of the Committee’s ongoing oversight of the pharmaceutical industry’s
research and marketing practices. The Committee has requested that AstraZeneca provide clinical and marketing information relating to
Seroquel and one letter requested pricing information for several AstraZeneca brands.
Since August 2007 AstraZeneca has received multiple letters from the Ranking Member of the Finance Committee of the US Senate requesting
information regarding AstraZeneca’s payments to certain identified physicians and their prescribing information related to Seroquel. In addition,
the Finance Committee requested sales and marketing information regarding the use of Seroquel in nursing homes. The Finance Committee
also requested information regarding use of a third party company for certain aspects of clinical studies and publications related to Seroquel, as
well as information regarding AstraZeneca’s transparency efforts in certain business areas. AstraZeneca is co-operating with both Committees.
INFoRmAl uS SECuRITIES ANd ExChANgE CommISSIoN (SEC) INquIRy
In October 2006, AstraZeneca received from the SEC a letter requesting documents related to its business activities in Italy, Croatia, Russia and
Slovakia for the period 1 October 2003 to the present. The SEC’s request generally seeks documents concerning any payments to doctors or
government officials and related internal accounting controls. The request also seeks policies, correspondence, audits and other documents
concerning compliance with the Foreign Corrupt Practices Act, as well as any allegations or communications with prosecutors’ offices relating
to corruption or bribery of doctors or government officials. AstraZeneca has produced documents in response to this request. It is not currently
possible to predict the outcome of this inquiry.
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EmploymENT-wAgE/houR lITIgATIoN
In September 2006, Marc Brody filed a putative class action lawsuit against AstraZeneca LP on behalf of himself and a class of approximately 844
pharmaceutical sales specialists employed by the Group in California during the period 19 September 2002 to the present. The plaintiff alleges
he and the proposed class members were unlawfully classified as exempt employees and denied overtime compensation and meal breaks in
violation of the California Labour Code. AstraZeneca removed this action to the US District Court for the Central District of California in October
2006. The plaintiff filed a first amended complaint in March 2007, for failure to provide meal and rest periods, failure to pay all wages earned
each pay period, failure to provide accurate wage statements, failure to pay wages in a timely manner upon termination of employment, unfair
competition and civil penalties. AstraZeneca denies the allegations made by the plaintiff, asserting that the sales specialists are properly
classified under various exemptions to the wage laws. Discovery is ongoing. (The plaintiff’s lawyers are also pursuing similar claims in lawsuits
against most of the major pharmaceutical companies).
In separate lawsuits against AstraZeneca, the firms representing the plaintiff filed additional state wage-and-hour class actions, the first under
the Pennsylvania Minimum Wage Act and Wage Payment Collection Law in the US District Court for the Western District of Pennsylvania on
behalf of two plaintiffs and a putative class of approximately 473 sales specialists working in Pennsylvania during the period March 2004 to
the present; and the second in the US District Court for the Southern District of New York on behalf of one plaintiff and a putative class of
approximately 890 sales specialists working in the state of New York during the period June 2001 to the present, claiming the sales specialists
were misclassified as exempt from overtime pay under New York labour law.
Additionally, in June 2007, the firms representing the plaintiff filed a nationwide collective action based on federal wage-and-hour law (FLSA) in
the US District Court for the District of Delaware, seeking unpaid overtime compensation and liquidated damages. The lawsuit has a potential
class size of 8,300 current and former sales specialists employed by the Group in the US during the period June 2004 to the present. The
parties have negotiated a stipulation of dismissal of this lawsuit, and the action has been dismissed with prejudice. The plaintiff’s counsel is
expected to file a new FLSA action with a different named plaintiff in the near future.
In June 2008, the US District Court, Central District of California, granted summary judgment in favour of AstraZeneca, dismissing all claims
filed by the named plaintiff, Marc Brody, and finding the motion for class certification to be moot. Plaintiff has filed a notice of appeal with the
Ninth Circuit Court of Appeals in California.
AstraZeneca is defending three putative class action lawsuits alleging various violations of state wage-and-hour laws by challenging the way
AstraZeneca has classified its sales representatives as exempt from overtime pay requirements. In Hummel v. AstraZeneca, the US District
Court for the Southern District of New York granted AstraZeneca’s motion for summary judgment and dismissed the case in September 2008.
In October 2008, Hummel filed a notice of appeal to the Second Circuit Court of Appeals. On 20 January 2009, the parties finalised a resolution
agreement that will result in Hummel dismissing the appeal with prejudice in exchange for AstraZeneca’s agreement to waive its costs.
TAxATIoN
Where tax exposures can be quantified, an accrual is made based on best estimates and management’s judgement. Details of the movements
in relation to material tax exposures are discussed below.
AstraZeneca faces a number of transfer pricing audits in jurisdictions around the world and, in some cases, is in dispute with the tax authorities.
The issues under discussion are often complex and can require many years to resolve. Accruals for tax contingencies require management to make
estimates and judgements with respect to the ultimate outcome of a tax audit, and actual results could vary from these estimates. The international
tax environment presents increasingly challenging dynamics for the resolution of transfer pricing disputes. These disputes usually result in
taxable profits being increased in one territory and correspondingly decreased in another. Our balance sheet positions for these matters reflect
appropriate corresponding relief in the territories affected. Management considers that at present such corresponding relief will be available
but given the challenges in the international tax environment will keep this aspect under careful review. The total net accrual included in the
Financial Statements to cover the worldwide exposure to transfer pricing audits is $1,628m, an increase of $306m due to a number of new
audits, revisions of estimates relating to existing audits, offset by a number of negotiated settlements and exchange rate effects.
Included in the total net accrual are amounts in respect of the following transfer pricing arrangements:
AstraZeneca and Her Majesty’s Revenue & Customs (HMRC) have made a joint referral to the UK Court in respect of transfer pricing between >
our UK and one of our overseas operations for the years 1996 to date as there continues to be a material difference between the Group’s and
HMRC’s positions. An additional referral in respect of controlled foreign company aspects of the same case was made during 2008. Absent a
negotiated settlement, litigation is set to commence in 2010.
AstraZeneca has applied for two advance pricing agreements (APAs) in relation to intra-group transactions between the UK and the US and >
the UK and Japan. Both APAs are being progressed through competent authority proceedings under the relevant double tax treaties.
Management continues to believe that AstraZeneca’s positions on all its transfer pricing audits and disputes are robust and that AstraZeneca
is appropriately provided.
For transfer pricing audits where AstraZeneca and the tax authorities are in dispute, AstraZeneca estimates the potential for reasonably
possible additional losses above and beyond the amount provided to be up to $400m; however, management believes that it is unlikely that
these additional losses will arise. Of the remaining tax exposures, AstraZeneca does not expect material additional losses. It is not possible
to estimate the timing of tax cash flows in relation to each outcome, however, it is anticipated that a number of significant disputes may be
resolved over the next one to two years. Included in the provision is an amount of interest of $365m. Interest is accrued as a tax expense.
163
FINANCIAL STATEMENTS
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
26 lEASES
Total rentals under operating leases charged to the income statement were as follows:
2008 2007 2006
$m $m $m
206 210 197
The future minimum lease payments under operating leases that have initial or remaining terms in excess of one year at 31 December 2008
were as follows:
2008 2007 2006
$m $m $m
Obligations under leases comprise
No later than one year 101 103 108
Rentals due after more than one year:
Later than five years 145 184 161
Later than one year and not later than five years 212 195 182
357 379 343
458 482 451
27 STATuToRy ANd oThER INFoRmATIoN
2008 2007 2006
$m $m $m
Fees payable to KPMG Audit Plc and its associates:
Group audit fee 3.2 3.6 3.1
Fees payable to KPMG Audit Plc and its associates for other services:
The audit of subsidiaries pursuant to legislation 7.1 6 .1 5.4
Other services pursuant to legislation 3.3 3.6 4.1
Taxation 0.9 1.1 1.2
All other services 1.7 0.7 1.0
Fees payable to KPMG Audit Plc in respect of the Group’s pension schemes:
The audit of subsidiaries’ pension schemes 0.6 0.6 0.5
16.8 15.7 15.3
Other services pursuant to legislation includes fees of $2.5m (2007: $2.7m; 2006: $3.2m) in respect of section 404 of the Sarbanes-Oxley Act.
Taxation services consist of tax compliance services and tax advice.
RElATEd pARTy TRANSACTIoNS
The Group had no material related party transactions which might reasonably be expected to influence decisions made by the users of these
Financial Statements.
kEy mANAgEmENT pERSoNNEl CompENSATIoN
Key management personnel are defined for the purpose of disclosure under IAS 24 ‘Related Party Disclosures’ as the Board of Directors, the
Senior Executive Team and the Company Secretary.
2008 2007 2006
$’000 $’000 $’000
Short-term employee benefits 21,973 31,525 21,321
Post-employment benefits 2,290 2,072 3,191
Share-based payments 13,210 11,515 8,417
37,473 45,112 32,9 29
Short-term employee benefits in 2007 include one-off employee costs of $11m in relation to the acquisition of MedImmune.
Total remuneration is included within employee costs (Note 24).
SubSEquENT EvENTS
There were no material subsequent events.
164
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
PRINCIPAL SUBSIDIARIES
Percentage of voting
At 31 December 2008 Country share capital held Principal activity
UK
AstraZeneca UK Limited England 100 Research and development,
manufacturing, marketing
AstraZeneca Treasury Limited England 100 Treasury
Continental Europe
NV AstraZeneca SA Belgium 100 Manufacturing, marketing
AstraZeneca Dunkerque Production SCS France 100 Manufacturing
AstraZeneca SAS France 100 Research, manufacturing, marketing
AstraZeneca GmbH Germany 100 Development, manufacturing, marketing
AstraZeneca Holding GmbH Germany 100 Manufacturing, marketing
AstraZeneca SpA Italy 100 Manufacturing, marketing
AstraZeneca Farmaceutica Spain SA Spain 100 Manufacturing, marketing
AstraZeneca AB Sweden 100 Research and development,
manufacturing, marketing
AstraZeneca BV The Netherlands 100 Marketing
The Americas
AstraZeneca Canada Inc. Canada 100 Research, manufacturing, marketing
AZ Reinsurance Limited Cayman Islands 100 Insurance and reinsurance underwriting
IPR Pharmaceuticals Inc. Puerto Rico 100 Development, manufacturing, marketing
AstraZeneca LP US 99 Research and development,
manufacturing, marketing
AstraZeneca Pharmaceuticals LP US 100 Research and development,
manufacturing, marketing
Zeneca Holdings Inc. US 100 Manufacturing, marketing
MedImmune, LLC US 100 Research and development,
manufacturing, marketing
Asia, Africa & Australasia
AstraZeneca Pty Limited Australia 100 Development, manufacturing, marketing
AstraZeneca KK Japan 80 Manufacturing, marketing
All shares are held indirectly.
The companies and other entities listed above are those whose results or financial position principally affected the figures shown in the Group
Financial Statements. A full list of subsidiaries, joint ventures and associates will be annexed to the Company’s next annual return filed with the
Registrar of Companies. The country of registration or incorporation is stated alongside each company. The accounting year ends of subsidiaries
and associates are 31 December, except for Aptium Oncology, Inc. which, owing to local conditions and to avoid undue delay in the preparation
of the Financial Statements, is 30 November. AstraZeneca operates through 283 subsidiaries worldwide. Products are manufactured in
18 countries worldwide and are sold in over 100 countries. The Group Financial Statements consolidate the Financial Statements of the
Company and its subsidiaries at 31 December 2008.
165
FINANCIAL STATEMENTS
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
INDEPENDENT AUDITOR’S REPORT TO THE MEMBERS OF ASTRAZENECA PLC
We have audited the Company Financial
Statements of AstraZeneca PLC for the year
ended 31 December 2008 which comprise
the Balance Sheet and the related notes on
pages 166 to 171. These Company Financial
Statements have been prepared under the
accounting policies set out therein. We have
also audited the information in the Directors’
Remuneration Report that is described as
having been audited.
We have reported separately on the Group
Financial Statements of AstraZeneca PLC
for the year ended 31 December 2008.
This report is made solely to the Company’s
members, as a body, in accordance with
section 235 of the Companies Act 1985.
Our audit work has been undertaken so that
we might state to the Companys members
those matters we are required to state to
them in an auditor’s report and for no other
purpose. To the fullest extent permitted by
law, we do not accept or assume responsibility
to anyone other than the Company and the
Companys members as a body, for our audit
work, for this report, or for the opinions we
have formed.
RESpECTIvE RESpoNSIbIlITIES oF
dIRECToRS ANd AudIToRS
The Directorsresponsibilities for preparing
the Annual Report and Form 20-F Information,
the Directors’ Remuneration Report and the
Company Financial Statements in accordance
with applicable law and UK Accounting
Standards (UK Generally Accepted Accounting
Practice) are set out in the Statement of
Directors’ Responsibilities on page 98.
Our responsibility is to audit the Company
Financial Statements and the part of the
Directors’ Remuneration Report to be audited
in accordance with relevant legal and
regulatory requirements and International
Standards on Auditing (UK and Ireland).
We report to you our opinion as to whether
the Company Financial Statements give
a true and fair view and whether the Company
Financial Statements and the part of the
Directors’ Remuneration Report to be audited
have been properly prepared in accordance
with the Companies Act 1985. We also report
to you whether in our opinion the information
given in the Directors’ Report is consistent
with the Company Financial Statements.
In addition we report to you if, in our opinion,
the Company has not kept proper accounting
records, if we have not received all the
information and explanations we require for
our audit, or if information specified by law
regarding Directors’ remuneration and other
transactions is not disclosed.
We read the other information contained in the
Annual Report and Form 20-F Information
and consider whether it is consistent with
the audited Company Financial Statements.
We consider the implications for our report
if we become aware of any apparent
misstatements or material inconsistencies
with the Company Financial Statements.
Our responsibilities do not extend to any
other information.
bASIS oF AudIT opINIoN
We conducted our audit in accordance with
International Standards on Auditing (UK and
Ireland) issued by the Auditing Practices Board.
An audit includes examination, on a test
basis, of evidence relevant to the amounts
and disclosures in the Company Financial
Statements and the part of the Directors’
Remuneration Report to be audited. It also
includes an assessment of the significant
estimates and judgements made by the
Directors in the preparation of the Company
Financial Statements, and of whether the
accounting policies are appropriate to the
Company’s circumstances, consistently
applied and adequately disclosed.
We planned and performed our audit so as
to obtain all the information and explanations
which we considered necessary in order to
provide us with sufficient evidence to give
reasonable assurance that the Company
Financial Statements and the part of the
Directors’ Remuneration Report to be audited
are free from material misstatement, whether
caused by fraud or other irregularity or error.
In forming our opinion we also evaluated
the overall adequacy of the presentation
of information in the Company Financial
Statements and the part of the Directors’
Remuneration Report to be audited.
opINIoN
In our opinion:
The Company Financial Statements give >
a true and fair view, in accordance with
UK Generally Accepted Accounting
Practice, of the state of the Company’s
affairs as at 31 December 2008.
The Company Financial Statements and >
the part of the Directors’ Remuneration
Report to be audited have been properly
prepared in accordance with the
Companies Act 1985.
The information given in the Directors’ >
Report is consistent with the Company
Financial Statements.
kpmg AudIT plC
Chartered Accountants
Registered Auditor
8 Salisbury Square
London EC4Y 8BB
29 January 2009
166
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
ASTRAZENECA PLC
bAlANCE ShEET
2007
2008 (restated)
At 31 December Notes $m $m
Fixed assets
Fixed asset investments 1 26,727 31,079
Current assets
Debtors – other 1 1
Debtors – amounts owed by group undertakings 8,217 6,984
8,218 6,985
Total assets 34,945 38,064
Creditors: Amounts falling due within one year
Non-trade creditors 2 (414) (4,353)
Interest bearing loans and borrowings 3 (650)
(1,064) (4,353)
Net current assets 7,154 2,632
Total assets less current liabilities 33,881 3 3,711
Creditors: Amounts falling due after more than one year
Amounts owed to group undertakings 3 (283) (283)
Interest bearing loans and borrowings 3 (10,255) (10,482)
(10,538) (10,765)
Net assets 23,343 22,946
Capital and reserves
Called-up share capital 6 362 364
Share premium account 4 2,046 1,888
Capital redemption reserve 4 94 91
Other reserves 4 2,743 2,565
Profit and loss account 4 18,098 18,038
Shareholders’ funds 5 23,343 22,946
$m means millions of US dollars.
The Financial Statements on pages 166 to 171 were approved by the Board of Directors on 29 January 2009 and were signed on its behalf by:
dAvId R bRENNAN SImoN lowTh
Director Director
167
FINANCIAL STATEMENTS
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
ACCOUNTING POLICIES
bASIS oF ACCouNTINg
The Company Financial Statements are prepared under the historical cost convention, modified to include revaluation to fair value of certainnancial
instruments as described below, in accordance with the Companies Act 1985 and UK Generally Accepted Accounting Principles (UK GAAP).
The Group Financial Statements have been prepared in accordance with International Financial Reporting Standards as adopted by the European
Union and are presented on pages 103 to 107.
The following paragraphs describe the main accounting policies under UK GAAP, which have been applied consistently.
NEw ACCouNTINg STANdARdS
The Company has adopted UITF Abstract 44 (IFRIC 11): ‘FRS 20 (IFRS 2) Group and Treasury Share Transactions’, which requires a parent
company to recognise a capital contribution in respect of share option awards granted to employees of its subsidiaries for services provided
to the subsidiary. The effect of adoption on the Company is to increase investments in subsidiaries for the aggregate amount of all such
contributions and to increase other reserves. Comparative information has been restated to reflect this.
The Company has also adopted Amendments to FRS 17 ‘Retirement Benefits’ and the Amendment to FRS 26 and FRS 29 ‘Reclassification
of Financial Assets’. The adoption of these amendments had no impact on the net results or net assets of the Company.
The Amendment to FRS 20 ‘Share-based Payment’, UITF Abstract 46 ‘Hedges of a Net Investment in a Foreign Operation’, Amendment to
FRS 26 ‘Financial Instruments: Recognition and Measurement – Eligible Hedged Items’ and Amendment to FRS 8 ‘Related Party Disclosures’
have been issued but not yet adopted by the Company.
FoREIgN CuRRENCIES
Profit and loss account items in foreign currencies are translated into US dollars at average rates for the relevant accounting periods. Assets
and liabilities are translated at exchange rates prevailing at the date of the Company balance sheet. Exchange gains and losses on loans and
on short term foreign currency borrowings and deposits are included within net interest payable. Exchange differences on all other transactions,
except relevant foreign currency loans, are taken to operating profit.
TAxATIoN
The charge for taxation is based on the result for the year and takes into account taxation deferred because of timing differences between the
treatment of certain items for taxation and for accounting purposes. Full provision is made for the effects of these differences. Deferred tax
assets are recognised where it is more likely than not that the amount will be realised in the future. These estimates require judgements to be
made including the forecast of future taxable income. Deferred tax balances are not discounted.
Accruals for tax contingencies require management to make judgements and estimates in relation to tax audit issues. Tax benefits are not recognised
unless the tax positions will probably be sustained. Once considered to be probable, management reviews each material tax benefit to assess
whether a provision should be taken against full recognition of that benefit on the basis of potential settlement through negotiation and/or litigation.
Any recorded exposure to interest on tax liabilities is provided for in the tax charge. All provisions are included in creditors due within one year.
INvESTmENTS
Fixed asset investments, including investments in subsidiaries, are stated at cost and reviewed for impairment if there are indications that the
carrying value may not be recoverable.
FINANCIAl INSTRumENTS
Loans and other receivables are held at amortised cost. Long-term loans payable are held at amortised cost.
lITIgATIoN
Through the normal course of business, AstraZeneca is involved in legal disputes, the settlement of which may involve cost to the Company.
Provision is made where an adverse outcome is probable and associated costs can be estimated reliably. In other cases, appropriate descriptions
are included.
168
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
NOTES TO THE COMPANY FINANCIAL STATEMENTS
1 FIxEd ASSET INvESTmENTS
Investments in subsidiaries
Shares Total
(restated) Loans (restated)
$m $m $m
Cost and net book value at 1 January 2008, as previously reported 15,286 15,069 30,355
Prior year adjustment – UITF 44 724 724
Restated at beginning of year 16,010 15,069 31,079
Additions 14,700 787 15,487
Disposals (14,700) (14,700)
Transfer to current assets (2,045) (2,045)
Capital contribution – UITF 44 178 178
Exchange (372) (372)
Amortisation 8 8
Repayment of loan (2,908) (2,908)
Cost and net book value at 31 December 2008 16,188 10,539 26,727
During 2007, the Company formed a new subsidiary, AstraZeneca Intermediate Holdings Limited. On 11 March 2008, the Company sold its
wholly owned subsidiary, AstraZeneca UK Limited, to AstraZeneca Intermediate Holdings Limited, in consideration for the issue of further shares in
AstraZeneca Intermediate Holdings Limited.
During the year, the Company has adopted the requirements of UITF Abstract 44 ‘Group and Treasury Share Transactions’ and restated prior
year comparatives.
2 NoN-TRAdE CREdIToRS
2008 2007
$m $m
Amounts due within one year
Short-term borrowings (unsecured) 173 4,123
Other creditors 228 206
Amounts owed to group undertakings 13 24
414 4,353
3 loANS
Repayment 2008 2007
dates $m $m
Amounts due within one year
Interest bearing loans and borrowings (unsecured)
US dollars
Floating Rate Note 2009 650
Amounts due after more than one year
Amounts owed to subsidiaries (unsecured)
US dollars
7.2% Loan 2023 283 283
Interest bearing loans and borrowings (unsecured)
US dollars
Floating Rate Note 2009 649
5.4% Callable bond 2012 1,742 1,741
5.4% Callable bond 2014 748 747
5.9% Callable bond 2017 1,742 1,741
6.45% Callable bond 2037 2,716 2,715
Euros
4.625% Non-callable bond 2010 1,053 1,099
5.625% Non-callable bond 2010 702
5.125% Non-callable bond 2015 1,051 1,099
Pounds sterling
5.75% Non-callable bond 2031 501 691
10,255 10,482
169
FINANCIAL STATEMENTS
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
3 loANS CoNTINuEd
2008 2007
$m $m
Loans or instalments thereof are repayable:
After five years from balance sheet date 7,041 7, 276
From two to five years 1,742 2,840
From one to two years 1,755 649
Within one year 650
Total unsecured 11,188 10,765
With the exception of the floating rate note, all loans are at fixed interest rates. Accordingly the fair values of the loans will change as market
rates change. However, since the loans are held at amortised cost, changes in interest rates and the credit rating of the Company do not have
any effect on the Company’s net assets.
4 RESERvES
Share Capital Other Profit 2007
premium redemption reserves and loss 2008 Total
account reserve (restated) account Total (restated)
$m $m $m $m $m $m
At beginning of year, as previously reported 1,888 91 1,841 18,038 21,858 19,063
Prior year adjustment – UITF 44 724 724 569
Restated at beginning of year 1,888 91 2,565 18,038 22,582 19,632
Profit for the year 3,436 3,436 9,407
Dividends (2,767) (2,767) (2,658)
Gain/(loss) on cash flow hedge in anticipation of debt issue 1 1 (21)
Share-based payment 178 178 155
Share re-purchases 3 (610) (607) (4,150)
Share premiums 158 158 217
At end of year 2,046 94 2,743 18,098 22,981 22,582
Distributable reserves at end of year 1,841 16,946 18,787 15,819
As permitted by section 230 (4) of the Companies Act 1985, the Company has not presented its own profit and loss account.
At 31 December 2008, $1,152m (31 December 2007: $4,060m) of the profit and loss account reserve was not available for distribution.
The majority of this non-distributable amount relates to profit arising on the sale of Astra AB to a subsidiary in 1999, which becomes
distributable as the underlying receivable is settled. During 2008, $2,908m (2007: $7,069m) of the profit was realised by repayment.
Subsequent to the year end, a further $371m was repaid on 20 January 2009, resulting in additional distributable reserves not included
in the figures above. Included in other reserves is a special reserve of $157m, arising on the redenomination of share capital in 1999.
During the year, the Company has adopted the requirements of UITF Abstract 44 ‘Group and Treasury Share Transactions’ and restated
prior year comparatives. The effect of adoption is to increase other reserves by $902m at 31 December 2008 (31 December 2007: $724m).
These amounts are not available for distribution.
5 RECoNCIlIATIoN oF movEmENT IN ShAREholdERS’ FuNdS
2007
2008 (restated)
$m $m
At beginning of year, as previously reported 22,222 19,446
Prior year adjustment – UITF 44 724 569
Restated at beginning of year 22,946 20,015
Net profit for the financial year 3,436 9,407
Dividends (2,767) (2,658)
Gain/(loss) on cash flow hedge in anticipation of debt issue 1 (21)
Share-based payment 178 155
Issue of AstraZeneca PLC Ordinary Shares 159 218
Re-purchase of AstraZeneca PLC Ordinary Shares (610) (4,170)
Net increase in shareholders’ funds 397 2,931
Shareholders’ funds at end of year 23,343 22,946
Details of dividends paid and payable to shareholders are given in Note 21 to the Consolidated Financial Statements on page 129.
170
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
6 ShARE CApITAl
Authorised Allotted, called-up and fully paid
2008 2008 2007
$m $m $m
Issued Ordinary Shares ($0.25 each) 362 362 364
Unissued Ordinary Shares ($0.25 each) 238
Redeemable Preference Shares (£1 each – £50,000)
600 362 364
The total authorised number of Ordinary Shares at 31 December 2008 was 2,400,000,000, of which 1,447,481,548 Ordinary Shares were
in issue.
The Redeemable Preference Shares carry limited class voting rights and no dividend rights. This class of shares is capable of redemption at par
at the option of the Company on the giving of seven days’ written notice to the registered holder of the shares.
The movements in share capital during the year can be summarised as follows:
No. of shares
(million) $m
At 1 January 2008 1,457 364
Issues of shares 4 1
Re-purchase of shares (14) (3)
At 31 December 2008 1,447 362
ShARE RE-puRChASES
During the year the Company re-purchased, and subsequently cancelled, 13,597,940 Ordinary Shares at an average price of 2397 pence per
share. The total consideration, including expenses, was $610m. The consideration has been charged against the profit and loss account reserve.
ShARE SChEmES
A total of 4,078,635 Ordinary Shares were issued during the year in respect of share schemes. Details of movements in the number of Ordinary
Shares under option are shown in Note 24 to the Group Financial Statements; details of options granted to Directors are shown in the Directors’
Remuneration Report.
ShARES hEld by SubSIdIARIES
No shares in the Company are held by subsidiaries.
7 lITIgATIoN ANd ENvIRoNmENTAl lIAbIlITIES
exAntA (xImElAgATRAN)
As previously disclosed, four putative and essentially similar securities class actions were filed in the US against AstraZeneca PLC, Håkan Mogren
(who currently serves as a Director of AstraZeneca PLC), Sir Tom McKillop, Jonathan Symonds and Percy Barnevik (who are former Directors
of AstraZeneca PLC) between January and March 2005. These actions were subsequently consolidated into a single action in the US District
Court for the Southern District of New York. The Consolidated Amended Complaint alleged that the defendants made materially false and
misleading statements regarding Exanta clinical trials and the status of the Exanta new drug application in the US. The plaintiffs purport to
assert claims on behalf of purchasers of AstraZeneca publicly traded securities during the period April 2003 to September 2004 under sections
10(b) and 20(a) of the Securities Exchange Act of 1934 and SEC Rule 10b-5.
In an opinion dated 3 June 2008, the US District Court for the Southern District of New York dismissed the case in its entirety by granting the
motions to dismiss of AstraZeneca PLC and the individual defendants. Plaintiffs are currently appealing this decision to the US Court of Appeals
for the Second Circuit, except for the ruling regarding two of the four individual defendants. AstraZeneca filed its brief in response to Plaintiff’s
appeal on 14 October 2008.
AstraZeneca PLC will continue to vigorously defend itself in this matter.
171
FINANCIAL STATEMENTS
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
INFoRmAl uS SECuRITIES ANd ExChANgE CommISSIoN (SEC) INquIRy
In October 2006, AstraZeneca received from the SEC a letter requesting documents related to its business activities in Italy, Croatia, Russia and
Slovakia for the period 1 October 2003 to the present. The SEC’s request generally seeks documents concerning any payments to doctors or
government officials and related internal accounting controls. The request also seeks policies, correspondence, audits and other documents
concerning compliance with the Foreign Corrupt Practices Act, as well as any allegations or communications with prosecutors’ offices relating
to corruption or bribery of doctors or government officials. AstraZeneca has produced documents in response to this request. It is not currently
possible to predict the outcome of this inquiry.
ANTI-TRuST
In January 2008 AstraZeneca, together with several other companies, was the subject of an unannounced inspection simultaneous with the
launch by the EU Commission (Commission) of a Sectoral Inquiry (Inquiry) into the pharmaceutical industry. The Inquiry relates to the introduction
of innovative and generic medicines and covers commercial and other practices, including the use of patents. On 28 November 2008 the
Commission published its preliminary report. The report does not identify wrongdoing by any individual companies but is stated to provide a
factual basis for further consideration. The Commission has stated that it will commence individual investigations where there are indications
that competition rules have been breached. The preliminary report focuses on a number of issues relating to competition in the EU, referring to
strategies which the Commission believes pharmaceutical companies use to block or delay generic entry. Such strategies include: patent filings
and enforcement; patent settlement agreements and other agreements; interventions before national regulatory authorities; and life-cycle
management strategies.
A final report is expected in Spring 2009. AstraZeneca has been co-operating fully with the Commission and participating in European
Federation for Pharmaceutical Industries and Associations activities.
oThER
The Company has guaranteed the external borrowing of a subsidiary, in the amount of $288m.
8 STATuToRy ANd oThER INFoRmATIoN
There are no employees of the Company (2007: nil). The Directors of the Company were paid by another Group company in 2008 and 2007.
172
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
GROUP FINANCIAL RECORD
2004 2005 2006 2007 2008
For the year ended 31 December $m $m $m $m $m
Revenue and profits
Revenue 21,426 23,950 26,475 29,559 31,601
Cost of sales (5,193) (5,356) (5,559) (6,419) (6,598)
Distribution costs (177) (211) (226) (248) (291)
Research and development (3,467) (3,379) (3,902) (5,162) (5,179)
Selling, general and administrative costs (8,268) (8,695) (9,096) (10,364) (10,913)
Other operating income and expense 226 193 524 728 524
Operating profit 4,547 6,502 8,216 8,094 9,144
Profit on sale of interest in joint venture 219
Finance income 532 665 888 959 854
Finance expense (454) (500) (561) (1,070) (1,317)
Profit before tax 4,844 6,667 8,543 7,983 8,681
Taxation (1,161) (1,943) (2,480) (2,356) (2,551)
Profit for the period 3,683 4,724 6,063 5,627 6,130
Attributable to:
Equity holders of the Company 3,664 4,706 6,043 5,595 6,101
Minority interests 19 18 20 32 29
Earnings per share
Earnings per $0.25 Ordinary Share (basic) $2.18 $2.91 $3.86 $3.74 $4.20
Earnings per $0.25 Ordinary Share (diluted) $2.18 $2.91 $3.85 $3.73 $4.20
Dividends $0.835 $1.025 $1.410 $1.750 $1.900
Return on revenues
Operating profit as a percentage of revenues 21.2% 27.2% 31.0% 27.4% 28.9%
Ratio of earnings to fixed charges 93.6 85.6 92.7 15.6 13.5
2004 2005 2006 2007 2008
At 31 December $m $m $m $m $m
Balance sheet
Property, plant and equipment, goodwill and intangible assets 11,147 9,697 11,657 29,649 29,240
Other investments 262 256 119 182 156
Deferred tax assets 1,218 1,117 1,220 1,044 1,236
Current assets 13,025 13,770 16,936 17,082 16,152
Total assets 25,652 24,840 29,932 47,957 46,784
Current liabilities (6,587) (6,839) (9,447) (15,187) (13,320)
Non-current liabilities (4,568) (4,310) (5,069) (17,855) (17,404)
Net assets 14,497 13,691 15,416 14,915 16,060
Share capital 411 395 383 364 362
Reserves attributable to equity holders 13,993 13,202 14,921 14,414 15,550
Minority equity interests 93 94 112 137 148
Total equity and reserves 14,497 13,691 15,416 14,915 16,060
2004 2005 2006 2007 2008
For the year ended 31 December $m $m $m $m $m
Cash flows
Net cash inflow/(outflow) from:
Operating activities 4,817 6,743 7,693 7,510 8,742
Investing activities 970 (1,182) (272) (14,887) (3,896)
Financing activities (2,761) (4,572) (5,366) 6,051 (6,362)
3,026 989 2,055 (1,326) (1,516)
RATIo oF EARNINgS To FIxEd ChARgES
For the purpose of computing these ratios, earnings consist of the income from continuing ordinary activities before taxation of Group companies
and income received from companies owned 50% or less, plus fixed charges. Fixed charges consist of interest on all indebtedness,
amortisation of debt discount and expense and that portion of rental expense representative of the interest factor.
remuneration report
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REmuNERATIoN CommITTEE
mEmBERSHIp ANd mEETINGS
The members of the Remuneration Committee
are John Varley (Chairman of the Committee),
John Buchanan, Louis Schweitzer and
Nancy Rothwell. They are all Non-Executive
Directors. The Board considers them all to be
independent (Louis Schweitzer was considered
independent upon his appointment as
Chairman of the Board; in accordance
with the UK Combined Code on Corporate
Governance, the test of independence is not
appropriate in relation to the Chairman after
his appointment). The independence of the
Non-Executive Directors is discussed in more
detail in the Directors’ Report on page 92.
The Company Secretary acts as the
secretary to the Remuneration Committee.
The Remuneration Committee met seven
times in 2008. Each meeting was attended
by all of its members, except that other
commitments prevented John Buchanan from
attending the meetings on 30 January 2008,
18 March 2008 and 10 December 2008.
Nancy Rothwell was also unable to attend
the meeting on 18 March 2008. Other
commitments prevented Louis Schweitzer from
attending the meeting on 10 December 2008.
At the request of the Remuneration
Committee, the Chief Executive Officer and
certain senior managers were invited to attend
meetings of the Remuneration Committee
throughout the year. Accordingly, the following
attended meetings of the Remuneration
Committee in 2008, except where their
own remuneration was being discussed:
David Brennan (Chief Executive Officer);
Lynn Tetrault (Executive Vice-President,
Human Resources and Corporate Affairs);
and Simon Appleby (Vice-President,
Performance and Reward). These individuals
provided advice and services that materially
assisted the Remuneration Committee during
the year. In so doing, they drew on various
sources of data concerning directors’ and
executives’ salaries, bonus levels and other
incentives including general pharmaceutical
industry reports and surveys, as well as surveys
specifically carried out for the Company, such
as those prepared by Towers Perrin.
During 2008, Carol Arrowsmith of Deloitte LLP
(Deloitte) was retained by the Remuneration
Committee to provide it with independent
advice on all matters being considered by it.
Deloitte also provided taxation advice and
other non-audit services to the Company.
REmuNERATIoN CommITTEE REmIT ANd
KEY ACTIVITIES duRING THE YEAR
A copy of the Remuneration Committee’s
remit is available on the Company’s website,
astrazeneca.com, or by request from the
Company Secretary.
KEY ACTIVITIES duRING THE YEAR
The Remuneration Committee considered
the following matters, amongst other things,
during 2008:
The terms of senior executives packages on >
appointment, promotion and termination.
As part of a benchmarking of the >
Committee’s activities and policies,
a review of the Company’s compliance
with institutional investor guidelines.
A review of guiding principles that inform >
the Company’s approach to total reward
arrangements to ensure that the
remuneration strategy supports the
business strategy.
Assessment of financial performance >
against earnings per share (EPS) targets
to determine the level of payment of
bonuses for 2007 and set EPS targets
for 2008.
Prepared, reviewed and approved the >
Directors’ Remuneration Report.
Approved the awards made under the >
Group’s main incentive plans (Performance
Share Plan and Share Option Plan) to
Senior Executive Team (SET) members
and other selected participants.
Developed long-term incentive (LTI) >
arrangements for a number of
subsidiary businesses which contribute
towards specific Group strategic and
commercial objectives.
Reviewed LTI arrangements in the >
light of age discrimination legislation.
Proposed remuneration and >
incentive arrangements to support
senior level recruitment.
DireCtorS’ remuneration report
“We have included in our work during
2008 an extensive benchmarking of the
activities and policies of the Remuneration
Committee to assess how these conform
with the continuous advance in best
practice in these areas. Our objective
in this work, as in all our work, is to
ensure that AstraZeneca’s remuneration
strategy supports its business strategy,
and thereby serves shareholders.”
JoHN VARlEY
Chairman of the Remuneration Committee
This Directors’ Remuneration Report has been
prepared in accordance with the Directors’
Remuneration Report Regulations 2002
(the Regulations) and meets the relevant
requirements of the Financial Services
Authority’s (FSA) Listing Rules. As required
by the Regulations, a resolution to approve
the report will be proposed at the Annual
General Meeting (AGM) on 30 April 2009.
The following sections of the Directors’
Remuneration Report up to and including
the section titled ‘Non-Executive Directors’
on page 181 were not subject to audit by
KPMG Audit Plc.
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ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
ASTRAZENECA’S oVERAll REmuNERATIoN
polICY ANd puRpoSE
The role of the Remuneration Committee 1.
is to help the organisation to create value
for shareholders over time through the
development and deployment of
remuneration policies and practices
that support the implementation of the
business strategy.
The Board is committed to maintaining 2.
a dynamic performance culture, in which
the Group can compete strongly by
employing and developing the best talent,
and where every employee is clear about
the Group’s objectives, how their work
will impact on those objectives and how
they will benefit from achieving high levels
of performance.
To underpin these objectives, in addition to 3.
fixed remuneration which comprises basic
pay, pension, and certain other benefits and
which is benchmarked against appropriate
external comparators, the majority of
employees are eligible to receive an annual
cash incentive. This incentive is determined
by reference to corporate, team and
individual performance. The component
based on corporate financial performance
is in the form of EPS. Whilst details of bonus
plans differ from country to country, the
EPS component ensures that all eligible
employees receive an element of reward
based on the Company’s overall financial
performance. In addition, LTI awards are
provided to selected senior employees in
order to align their interests closely with
those of the Company’s shareholders.
Pay for performance principles apply 4.
throughout the Group and provide
a consistent framework within which
executive remuneration decisions are made.
The Remuneration Committee has 5.
responsibility for determining the
individual compensation paid to the Chief
Executive Officer and members of the
SET; and for the approval of any single
payment or award over $1,000,000.
The Remuneration Committee seeks 6.
to ensure that the overall proportion of
variable pay (bonuses and share-based
awards) to which Directors and members
of the SET may become entitled form a
significant part of their overall remuneration
opportunity. The Remuneration Committee’s
objective is to ensure that such variable
pay is linked to a range of measures
designed to promote both individual and
team behaviour and performance in a way
that supports the success of AstraZeneca
and creates value for shareholders. Such
measures are designed to be stretching
and challenging to the relevant individuals.
The Group’s overall remuneration policy 7.
and purpose is to:
Attract and retain people of the quality >
necessary to sustain AstraZeneca
as one of the best pharmaceutical
companies in the world.
Enable AstraZeneca to employ the >
best people and to develop the best
talent by recognising and rewarding
superior performance.
Motivate these people in order to >
achieve the level of performance
necessary to create sustained growth
in shareholder value through time.
Align the interests of employees with >
those of shareholders.
Align individual and team reward with >
business performance at each level.
Encourage employees to perform to >
their fullest capacity.
Create pay structures that are fair, >
equitable and internally consistent.
Ensure that pay structures are both >
competitive and cost effective in each
of the relevant employment markets.
Ensure proper balance of fixed and >
variable performance-related pay.
CompoNENTS oF REmuNERATIoN
During 2008, the components of employee
remuneration (including that of the Executive
Directors and SET members) comprised fixed
and variable (ie performance-related) elements,
as set out below.
Annual salary – based on conditions in the >
relevant geographic market and the value
of an individual’s sustained personal
performance to the business, resulting
from their ability and experience.
Pension arrangements – appropriate to >
the relevant national market.
Benefits (such as healthcare) – >
cost-effective and compatible with
relevant welfare arrangements.
Short-term bonus – a lump sum payment >
related to the targeted achievement of
corporate, functional and individual goals,
measured over a year and contained within
a specific plan. The corporate goals are
derived from the annual financial targets
set by the Board and take into account
external expectations of performance.
The functional goals are agreed by the
Remuneration Committee at the start of
the year. These functional goals are derived
from the Business Scorecard, the key
elements of which are set out in the strategy,
goals and performance measurement
table on page 12, and are monitored
thereafter as part of a Quarterly Business
Review. Individual goals are based on
annual objectives, which are linked to
functional goals.
LTI arrangements – for selected groups, >
targeted at the achievement of strategic
objectives closely aligned with the interests
of shareholders, namely the AstraZeneca
Performance Share Plan (PSP) described
on page 179, and the AstraZeneca Share
Option Plan described on page 180, and in
line with market practice. Some individuals
(primarily those based in the US, but
excluding Executive Directors) participate
in the Restricted Stock Unit Award Plan
described on page 180.
Share participation – various plans >
provide the opportunity for employees
to take a personal stake in the Companys
wealth creation as shareholders. These
plans are described in Note 24 to the
Financial Statements.
Base
salary
Benefits
(such as
healthcare)
Pension
FIXED ELEMENTS
Fixed
elements
Linked to
short-term
performance
Bonus Deferred
Bonus Plan
(share based)
Linked to
long-term
performance
Share
Option
Plan
Performance
Share
Plan
VARIABLE ELEMENTS
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ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
For 2009, the Executive Directors’ annual
salaries are on page 177.
Pension arrangements
The table on page 183 gives details of the
changes in the value of the Executive
Directors’ accrued pensions during 2008.
US Executive Directors’
pension arrangements
David Brennan is a member of the AstraZeneca
US Defined Benefit Pension Plan, by virtue of
his membership of pension plans applicable
to legacy Astra Merck employees. Benefits
for members of this plan are delivered on a
tax-qualified basis, with accrued benefits that
exceed specific limits under the plan’s formula
and the US Tax Code being delivered through
a supplementary, non-qualified plan. The
normal pension age under both plans is 65.
As previously disclosed, in September 2008,
David Brennan satisfied a condition in the
pension plan relating to combined age
and service exceeding 85 years, which is
a condition that applies to all members within
the pension plan. On leaving or retiring from
employment, he is eligible to take a pension
or lump sum equivalent based on accrued
service and final pensionable pay (ie without
actuarial reduction). This change in status
under the pension plan triggered an increase
in transfer value during 2008.
David Brennan’s participation in the pension
plan is subject to a service cap at 35 years
service, which will be attained in January
2011, after which no further service accrual
can be earned.
Members and, in the event of death,
surviving spouses/dependants can elect to
take pensions in lump sum form based on
actuarial valuation.
EXECuTIVE dIRECToRS’ ANd SENIoR
EXECuTIVE TEAm’S REmuNERATIoN
ANd TERmS oF EmploYmENT
IlluSTRATIoN oF FIXEd ANd VARIABlE REmuNERATIoN
Based on AstraZeneca’s remuneration policy,
the charts on page 177 illustrate the potential
weighting given to fixed and variable elements
of the remuneration package at Executive
Director level. Performance-related elements
of the package are shown on an ‘Expected
Value’ basis, and in the event that performance
conditions are not met, such elements would
not deliver any value. The ‘Expected Value’
approach considers the range of possible
outcomes and the probability attached to each,
in order to provide a value that represents
the average that would be delivered if the
arrangements were operated over many years.
The ‘Expected Value’ for bonus payment is
taken to be the target payout level.
FIXEd REmuNERATIoN
All Executive Directors’ terms and conditions
are UK-based, apart from David Brennan’s
pension and health insurance arrangements,
which are described below.
Basic salary
The basic salary for each Executive Director
and SET member is determined by the
Remuneration Committee. Recognising
the external economic environment, the
Remuneration Committee did not increase
the salaries of Executive Directors or other
members of the SET for 2009, other than
in respect of situations where additional
responsibilities had been taken on. Salary
decisions reflect the experience and
sustained performance of the individuals to
whom they apply, taking account of market
competitiveness and the level of increases
applicable to employees in the wider Group.
For the Executive Directors and other
members of the SET, the policy has been
to position salaries at or slightly above the
median of the relevant market.
The way in which these elements of
remuneration were combined and applied
varied according to a range of factors including
specific business needs and practices in
different geographic markets, although, in
general, the more senior the role within the
business, the greater the proportion of total
remuneration was made up from variable pay.
Components of remuneration are taken into
account both separately and in their totality
in judging the value of a package. For 2009,
the Company will continue to benchmark
against appropriate comparator companies
and will assess whether or not and to what
extent the overall opportunities for remuneration
offered by the current structure of remuneration
remain appropriate in the context of changes
within the business and the external
environment in which it operates.
Recognising that shareholder approval to
operate the AstraZeneca Share Option Plan
will expire at the end of its 10-year life during
2010, and that it will be necessary to seek
further shareholder approval in order to
continue operating the plan beyond this date,
the Remuneration Committee intends to
consider whether or not the Company’s
established remuneration policy and the
operation of the existing incentive plans
continue to meet the needs of the business
in securing key senior executive talent to
grow shareholder value. This will build on a
review of remuneration policy started during
2008. To the extent that any material changes
are to be proposed as a consequence of this
review, the Remuneration Committee will
consult with shareholders in advance of next
year’s AGM.
CompoNENTS oF REmuNERATIoN – FIXEd ANd VARIABlE
CHIEF EXECUTIVE OFFICER EXECUTIVE DIRECTOR
FIXED
22% BASE SALARY
VARIABLE
35% PSP
22% BONUS
21% OPTIONS
FIXED
28% BASE SALARY
VARIABLE
29% PSP
26% BONUS
17% OPTIONS
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ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
Benefits
In conjunction with the majority of employers,
certain benefits are made available to the
Executive Directors and members of the SET
via local benefits programmes offered by
AstraZeneca. Benets under these programmes
typically include health care, insurances and
facilitated car purchase arrangements.
VARIABlE REmuNERATIoN
Executive Directors and members of the
SET are eligible to participate in a number
of different elements of variable pay, which
are described below. The decision as to
whether or not in any given year the Executive
Directors and members of the SET receive
any or all of their elements of variable pay is
determined by the Remuneration Committee,
which will typically have regard to the
performance of the individual and will consider
the elements of variable pay applicable
to senior employees in other comparable
organisations in making such a determination.
Short-term bonus
Performance criteria
All Executive Directors and members of
the SET are eligible for a short-term bonus.
The basis for the payment of any short-term
bonus is determined by reference to a range
of factors linked to the underlying performance
of AstraZeneca’s business, the performance
of the functional area for which the individual
is responsible and the performance of the
individual in his or her role.
Structure and assessment of performance
The annual bonus for Executive Directors and
members of the SET is based on performance
criteria linked to the following targets:
50% by reference to EPS targets set at >
the start of the financial year;
25% by reference to measures and >
initiatives as set out in, or derived from,
the strategy, goals and performance
measurement table on page 12 relevant to
the individual’s functional accountability (or,
in the case of the Chief Executive Officer, the
average of these individual outcomes); and
25% by a balance of qualitative and >
quantitative objectives that address overall
business performance, the key elements
of which are set out in the strategy, goals
and performance measurement table on
page 12.
to HM Revenue & Customs limits, in return
for an adjustment to their own pension of
equivalent actuarial value. Pensions are also
payable to dependent children.
Pensions in payment are increased annually
in line with inflation, as measured by the UK
Retail Prices Index, up to a maximum of 5%.
Simon Lowth (Chief Financial Officer) is
eligible to join AstraZeneca’s main UK defined
contribution pension plan at a Company
contribution rate of 24% of annual basic
salary, or alternatively, to take the Company
contribution as a cash allowance. For the
option year 2008/2009, he has elected to
take the cash allowance (as detailed in the
pensions section on page 183).
In the event of a senior employee in the main
UK defined benefit pension plan becoming
incapacitated, then a pension is payable
immediately as if such person had reached
normal retirement age (subject to a maximum
of 10 years’ additional service), based on
current pensionable salary. In the event of
a member’s death prior to retirement,
dependants are entitled to a pension of
two-thirds of the pension that would have
been earned had the deceased remained in
service to age 62, plus a capital sum of four
times pensionable pay.
In the event of a senior employee in the
main UK defined contribution pension plan
(or where an alternative cash allowance has
been taken) becoming incapacitated, then
permanent health insurance cover provides
continuation of a proportion of salary subject to
the satisfaction of certain medical criteria. In the
event of death prior to retirement, dependants
are entitled to a pension and/or lump sum
secured from a multiple of ten times salary.
In addition, David Brennan is a contributing
member of the US 401(k) savings plan
2
, as
applies to all US employees.
In the event of a US participant becoming
incapacitated then permanent health
insurance cover will provide continuation
of a proportion of salary, subject to the
satisfaction of certain medical criteria.
UK Executive Directors’
pension arrangements
UK Executive Directors have the option to
participate in the UK Pension Fund according
to their eligibility, or to take a cash allowance
in lieu of pension. The cash allowance is
consistent with the appropriate value of the
alternative gross pension benefit.
John Patterson (Executive Director,
Development) elected to take the cash
allowance in lieu of pension for the option
year 2008/2009 (as detailed in the pensions
table on page 183).
In respect of pension accrued up to that point
he remains a member of the AstraZeneca
main UK defined benefit pension plan.
The normal pension age under this plan is
62. However, a member’s accrued pension
is available from age 60 without any actuarial
reduction. John Patterson, having reached age
60 in January 2008, on retiring on 31 March
2009, will be eligible to take a pension based
on accrued service and final pensionable pay.
On death in retirement, the accrued pension
is guaranteed payable for the first five years
of retirement and then reduces to two-thirds
of this amount should there be a surviving
spouse or other dependant. Any member
may choose higher or lower levels of
survivor’s pensions at retirement, subject
EXECuTIVE dIRECToRS’ SAlARIES 2009
Annual salary Annual salary
in 2008 in 2009
Executive Director £ £ % Increase
David Brennan 972,900 972,900 0
John Patterson
1
540,000 540,000 0
Simon Lowth 550,000 550,000 0
1
John Patterson will retire from the Board on 31 March 2009.
CompoNENTS oF REmuNERATIoN – EXpECTEd VAluE BASIS
2
The 401(k) savings plan is a qualified plan to which
eligible employees may make salary-deferral
contributions on a post-tax and/or pre-tax basis.
Employers may also make matching or non-elective
contributions to the plan. There is a supplementary
non-qualified plan in place for all eligible employees
whose earnings exceed specific limits.
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ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
These achievements were underpinned by
a continuing emphasis on cost discipline,
improved productivity and performance
management. Having assessed the
Company’s performance as set out above,
the Remuneration Committee is satisfied
that the bonus payments that have been
earned against stretching performance
targets that were set at the start of the year
are fully justified.
Bonus share deferral requirements
Consistent with best practice, the
Remuneration Committee has put in place
a requirement that a certain proportion of any
short-term bonus payment be deferred and
invested into Ordinary Shares or American
Depositary Shares (ADSs) in the Company
acquired on the open market at the prevailing
market price and held on behalf of individual
Executive Directors and SET members by the
Company for a period of three years from the
date of acquisition. This arrangement is one
of the ways in which, over time, Executive
Directors and members of the SET will be
able to build up a significant shareholding in
the Company. Although the delivery of these
shares to the individual after three years is not
contingent on the continued performance of
the Company, the Remuneration Committee
has reserved the right to retrospectively alter
bonus outcomes in circumstances where it
does not consider that the delivery of shares
is warranted by the underlying performance
of the business. The proportion currently
deferred into shares is one third of the pre-tax
bonus for Executive Directors and one sixth
for all other SET members. On leaving,
participants would normally have to wait for
the shares to be released at the end of the
three-year period.
Long-term incentive plans
Executive Directors and members of the SET
may also be granted share options under the
AstraZeneca Share Option Plan and awards
under the AstraZeneca Performance Share
Plan. The grant of such options and award
of such shares are determined by the
Remuneration Committee, as are the
performance targets that apply to their
vesting and/or exercise. Both of these
schemes are intended to align the interests
of Executive Directors and members of the
SET with those of shareholders. Following
the exercise of an option under the
AstraZeneca Share Option Plan it is the
expectation of the Remuneration Committee
that Executive Directors and members of the
Bonus outcomes for 2008
Bonus outcomes for 2008 reflected
performance in respect of EPS, together
with overall business and financial outcomes
and relevant functional performance against
clear measures and initiatives in support of the
strategic priorities and business objectives,
the key elements of which are set out in the
strategy, goals and performance measurement
table on page 12, in relation to the following
categories which are consistent with delivering
shareholder value:
Strengthen the pipeline. >
Grow the business. >
Reshape the business. >
Promote a culture of responsibility >
and accountability.
The bonus outcomes for the Executive
Directors for 2008 are shown in the table below.
In respect of the assessment of bonuses
for 2008, EPS (excluding restructuring and
synergy costs), global sales and operating
profit (excluding restructuring and synergy
costs) were taken into account in particular
by the Remuneration Committee, which also
noted growth in the share price and relative
total shareholder return (TSR) performance.
The Remuneration Committee also noted
that the development pipeline now comprises
98 clinical projects. The Phase III portfolio
remained constant with 10 projects. We
delivered 32 FGLPs and delivered 17 first time
in man. Good progress was made in product
development life-cycle management with eight
significant submissions across a number of
jurisdictions, and two product submissions.
Following a review by the Remuneration
Committee, it has been agreed that the
performance criteria for the determination
of annual bonus for Executive Directors and
members of the SET for bonus year 2009
will be adjusted to align with the current
objectives and measures that are used by
the business as follows:
60% by reference to a group of Corporate >
objectives comprising: EPS and cashow
targets, together with objectives in each
of the strategic priority areas identified
by the Board for the business, the key
elements of which are set out in the
strategy, goals and performance
measurement table on page 12; and
40% by reference to individual measures >
and initiatives which link to the business
objectives relevant to the individual’s
functional accountability (or, in the case
of the Chief Executive Officer, the average
of these individual outcomes).
These changes will further enhance
AstraZeneca’s emphasis on individual and
business accountability. The key measures
referred to above are clearly set out in the
strategy, goals and performance measurement
table described on page 12, whereby Group
and Functional objectives and measures are
managed in a robust and consistent way and
assessed by the SET as part of a Quarterly
Business Review. The outcome of this process
is rigorously scrutinised by the Board.
Bonus ranges for 2009
For 2009, the bonus ranges for each Executive
Director are shown below and are the same
as for 2008.
BoNuS RANGES FoR 2009
Bonus range for 2009
Executive Director %
David Brennan 0 – 180
John Patterson
1
0 – 150
Simon Lowth 0 – 150
1
John Patterson’s bonus for 2009 will be considered by the Remuneration Committee in January 2010,
when performance outcomes are known and, to the extent that any bonus is payable, will be based on his
eligible earnings for the period in 2009 prior to retirement.
BoNuS ouTComES FoR 2008
Short-term bonus Percentage
(delivered as a combination of cash and shares, as shown in the table of emoluments)
1
of salary
Executive Director £000 %
David Brennan 1,295 133
John Patterson 522 97
Simon Lowth 704 128
1
Bonuses for Executive Directors are not pensionable.
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remuneration report
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
allow Awards to vest or to only allow them
to partially vest where this appears to the
Remuneration Committee to be warranted.
The Remuneration Committee has the
discretion to award Shares up to a further 25%
over and above the Shares subject to the
Award, if the Company’s TSR performance
is substantially better than that of the upper
quartile of the comparator group.
Individual limit
In respect of any financial year, the maximum
market value of Shares that may be put under
Award in respect of an employee is 500%
of that employee’s basic salary. This limit
excludes the above 25% maximum additional
Shares that may vest, at the sole discretion of
the Remuneration Committee, if the Companys
TSR performance is substantially above
that of the upper quartile of the comparator
group. For Awards to vest at this level, the
Company would need to have sustained
a level of performance well in excess of
upper quartile over a period of years and
the Remuneration Committee would need
to be satisfied that this was warranted.
The actual individual limits that apply under the
PSP, subject to this maximum, are set by the
Remuneration Committee from time to time.
Performance under the AstraZeneca
Performance Share Plan in 2008
The peer group graphs on page 184 show,
for each Award, how the Company’s TSR
performance has compared with the TSR for
the companies in the comparator group from
the first day of the relevant performance
period to 31 December 2008 and how the
Company ranks against those other peer
companies on this basis. We will continue
to report on the performance of each Award
against the relevant performance target
during the relevant vesting period.
Change in control provisions
On a change in control of the Company as a
result of a general offer to acquire the whole
of the issued ordinary share capital of the
Company, Awards will vest pro-rata to the
time elapsed between the date of grant of the
Award and the date of the change in control
to the extent that the relevant performance
targets have been met up to the date of the
change in control (or the most practicable
earlier date). The Remuneration Committee
will, however, have discretion to take into
account any other factors it believes to be
relevant in determining the extent to which
Awards will vest in these circumstances.
in relevant employment under certain
circumstances during the vesting period
to the extent that the performance targets
have been met.
Performance period and vesting dates
In the case of all Awards granted so far, the
performance target relates to the three-year
period commencing on 1 January of the year
of grant. Thus, for the Awards made in 2008,
the performance period runs from 1 January
2008 to 31 December 2010. The vesting date
is the third anniversary of the date of grant.
Performance targets
For all Awards so far to Executive Directors
and SET members, the performance target
is the Company’s TSR over the relevant
three-year period compared with the TSR
of a selected peer group of pharmaceutical
companies for the same period. These
companies are currently a total of 12: Abbott
Laboratories, Bristol-Myers Squibb, Eli Lilly,
GlaxoSmithKline, Johnson & Johnson, Merck,
Novartis, Pfizer, Roche, Sanofi-Aventis,
Schering-Plough and Wyeth.
TSR evaluates share price growth and
dividends re-invested in respect of a notional
number of shares, from the beginning of the
relevant performance period to the end of
it, and ranks the companies in the selected
comparator group by reference to their TSR
achieved over that period. The rank which
the Company’s TSR achieves over the
performance period will determine how
many Shares will vest under the relevant
Award, as per the vesting schedule shown
in the table below:
TSR ranking Vesting percentage of
of the Company Shares under Award %
Below median 0
Median 30
Upper quartile 100
Between median and upper quartile Pro rata
Significantly above upper quartile up to 125
To alleviate any short-term volatility, the return
index is averaged in the TSR calculations
for each company over the three months
prior to the start and end of the relevant
performance period.
In addition to the TSR performance target
being met for each Award as set out above,
the Remuneration Committee also has to
satisfy itself that achievement of the TSR
performance target is a genuine reflection
of the Company’s underlying financial
performance and has the discretion to not
SET will retain the net number of shares from
the exercise for a period of not less than six
months from the date of exercise.
Shareholding guidelines
For Executive Directors and members of
the SET, the Remuneration Committee has
established target shareholding guidelines,
under which it is expected that they build up
their own holding of shares in the Company,
equivalent to their basic salary. It is expected
that these shareholding targets will be
reached in part through shares delivered
from the various LTI arrangements as well
as the deferred part of the short-term bonus
(described above).
AstraZeneca Performance Share Plan
The AstraZeneca PSP was approved by
shareholders at the AGM in 2005 and provides
for the grant of performance share awards
(Awards) over Ordinary Shares or ADSs in
AstraZeneca PLC (together, the Shares).
Basis of participation
The Remuneration Committee is responsible
for setting the policy for the way in which the
PSP should be operated, including agreeing
performance targets, identifying which
employees should be invited to participate in
the PSP and the level of Awards. Participation
is highly selective and tends only to include
senior employees on the basis of their
performance. Awards are not pensionable and
may not generally be assigned or transferred.
Generally, Awards can be granted at any
time (although in practice they are awarded
annually), but not during a close period of the
Company. In 2008, the main grant of Awards
was made on 28 March, with other awards
approved by the Remuneration Committee
in relation to, for example, new appointments
or promotions granted on 22 August. The
value of the shares subject to the Award
is determined by reference to the market
price of Shares over the three-day period
immediately preceding the date of grant.
Details of Awards to Executive Directors are
shown in the table on page 186.
Performance conditions
Save in exceptional circumstances, which
are prescribed in the PSP rules, the vesting
of Awards is contingent on the satisfaction of
specified performance targets and continued
employment with the Group. In addition to
the satisfaction of these performance targets,
Awards will generally not vest until the third
anniversary of the date of grant although
Awards may vest in part on a time pro-rated
basis where a participant ceases to be
180
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
Dilution
The dilutive effect of the grants of Awards on
the Company’s issued share capital was also
considered by the Remuneration Committee,
in accordance with its commitment, reflecting
the guidance of the Association of British
Insurers, that the percentage of the issued
share capital that could be allocated under
all of the Companys employee share plans
over a period of 10 years should be under
10%. This commitment is applied by the
Remuneration Committee in practice as
a limit, on average, of under 1% per annum.
The Remuneration Committee concluded that
a grant of Awards to those plan participants
and individual Executive Directors proposed
for a grant was appropriate given the level
of performance achieved. None of the other
LTI arrangements currently operated by the
Company have a dilutive effect because they
do not involve the issue and allotment of new
Shares or ADSs in the Company but rather
rely on the market purchase of Shares or
ADSs that have already been issued.
Zeneca 1994 Executive
Share Option Scheme
This plan was replaced by the AstraZeneca
SOP. The last grant of options under this
plan was in March 2000. Certain Executive
Directors and members of the SET have
options outstanding under this plan, all of
which are exercisable, the performance
conditions having been satisfied. A description
of this plan can be found on page 142.
Other plans
In addition to the plans described above,
the Company operates a Share Incentive
Plan and a Savings-Related Share Option
Plan, both of which are UK HM Revenue &
Customs approved plans. Certain Executive
Directors and members of the SET are
eligible to participate in these plans, more
detailed descriptions of which can be found
on pages 139 and 142.
Restricted Stock Unit Plans
The AstraZeneca Pharmaceuticals LP
Restricted Stock Unit Award Plan (RSU Plan)
was introduced in 2007 and provides for the
grant of restricted stock unit awards (Awards)
to selected employees (predominantly in the
US). The MedImmune, Inc. 2008 Restricted
Stock Unit Award Plan (MedImmune RSU
Plan) was introduced in 2008 to make awards
to employees of MedImmune. The RSU Plan
and MedImmune RSU Plan are used in
conjunction with the AstraZeneca SOP to
As well as taking into account these
performance considerations at the point of
granting Awards, the Remuneration Committee
imposed performance conditions in respect
of the exercise of such Awards in respect
of members of the SET (including the
Executive Directors) which, in the view of the
Remuneration Committee were considered
appropriately stretching. In order for Awards
to vest, the EPS of the Group must increase
at least in line with the UK Retail Price Index
plus 5% per annum on average, over a three
year period, the base figure being the EPS
for the financial year preceding the date of
grant, with no re-testing. In addition, since
the review of executive remuneration in 2004,
the Remuneration Committee has included
a condition that, if an event occurs which
causes material reputational damage to the
Company, such that it is not appropriate for
the Awards to vest and become exercisable,
the Remuneration Committee can make a
determination to reflect this.
The Remuneration Committee also sought
and received assurances that each individual
proposed for the grant of an Award has been
performing in a manner that justified a grant to
them. There was some variation in the level of
grants being proposed between individuals,
to reflect differing levels of performance and
their seniority within the business.
Change in control provisions
On a change in control of the Company
as a result of a general offer to acquire the
whole of the issued ordinary share capital
of the Company, any unvested Awards vest
immediately following the change in control.
All outstanding vested Awards can be
exercised during the period of six months
from the date of the change in control.
The Company will use its best endeavours
to ensure that any shares acquired from an
exercise following a change in control are
subject to the same terms as shares of the
same class were acquired under the general
offer. Unexercised Awards will lapse at the
end of the six-month period following a change
in control or, if the Award is exchanged for an
option relating to shares in a different company,
the date of exchange, whichever is earlier.
AstraZeneca Share Option Plan
The AstraZeneca Share Option Plan (SOP)
was approved by shareholders at the AGM
in 2000 and provides for the grant of share
option awards (Awards) over Ordinary
Shares or ADSs in AstraZeneca PLC
(together, the Shares).
This plan was approved for a period of
10 years. Recognising this, the Company
intends to begin the process of consulting
with key institutional shareholders during
2009 in relation to any proposal to adopt
a new plan for 2010.
Basis of participation
The Remuneration Committee is responsible
for setting the policy for the way in which the
SOP should be operated, including agreeing
performance targets and identifying which
employees should be invited to participate
and the level of Awards. Participation is highly
selective and tends only to include senior
employees on the basis of their performance
(except in the US where for cultural reasons,
participation in the SOP is more widespread).
Awards are not pensionable and may not
generally be assigned or transferred.
Generally, Awards can be granted at any time,
but not during a close period of the Company.
In 2008, grants of Awards were made on
28 March and 22 August. The exercise price
is fixed by reference to the market price of
Shares over the three-day period immediately
preceding the date of grant.
Details of Awards to Executive Directors are
shown in the table on page 187.
Performance conditions
The AstraZeneca SOP, in particular, requires
the Remuneration Committee, before agreeing
to grant an Award to Executive Directors
and others, to consider whether or not the
underlying performance of the Company
justifies a grant. In addition, it must also be
satisfied that each individual nominated is
performing to the necessary standard.
In agreeing grants of Awards in 2008, the
Remuneration Committee took into account
strong underlying financial performance and
progress towards achieving longer-term goals.
181
remuneration report
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
Policy on external appointments
and retention of fees
Subject to the specific approval of the
Board in each case, Executive Directors and
members of the SET may accept external
appointments as non-executive directors of
other companies and retain any related fees
paid to them provided always that such
external appointments are not considered by
the Board to prevent or reduce the ability of
the Executive to perform his or her role to the
required standard. Such appointments are
seen as a way in which Executives can gain
a broader business experience and, in turn,
benefit the Company.
John Patterson is a non-executive director of
Cobham plc. In respect of such position, he
retained the fees paid to him for his services
which, in 2008, totalled £51,500.
Non-Executive Directors
None of the Non-Executive Directors has
a service contract. They are not eligible for
performance-related bonuses or the grant
of share options. No pension contributions
are made on their behalf. None of the
Non-Executive Directors has participated
or will participate in any decision made by
the Board in relation to the determination of
their own fees. In addition to the mandatory
shareholding requirement imposed on all
Directors under the Company’s Articles
of Association described on page 197,
in December 2008 the Board agreed that
each Non-Executive Director should also
be encouraged to build up, over time,
a shareholding in the Company with a value
approximately equivalent to the basic annual
fee for a Non-Executive Director (£60,000) or,
in the case of the Chairman, approximately
equivalent to his annual fee (£325,000).
provide a mix of restricted stock units and
share options. Awards typically vest on the
third anniversary of the date of grant and are
contingent on continued employment with
AstraZeneca. In 2008, Awards were made
under these plans on 28 March and 22 August.
Neither of these plans is used to make Awards
to Executive Directors or SET members.
Restricted Share Plan
The AstraZeneca Restricted Share Plan was
introduced in 2008 and provides for the grant
of restricted share awards to key employees,
excluding serving Executive Directors.
Awards are made on an ad hoc basis with
variable vesting dates. The plan has been
used twice in 2008 to make awards to four
employees. The Remuneration Committee
has responsibility for agreeing any awards
under the plan and for setting the policy for the
way in which the plan should be operated.
Service contracts
Details of the service contracts for each of
the Executive Directors, including their notice
periods, are set out below. The notice
periods in the Executive Directors’ service
contracts are 12 months. It is the Board’s
intention that, in the event of early termination
of an Executive Director’s employment, any
compensation payable under the service
contract should not exceed the salary and
benefits that would have been received had
the contractual notice period been worked
and this may be further reduced in line with
the Executive Director’s duty to mitigate losses.
Compensation for any bonus entitlement will
be assessed initially as ‘on target’ but subject
to adjustment by the Remuneration Committee
to take account of the particular circumstances
of the termination.
dETAIlS oF EXECuTIVE dIRECToRS’ SERVICE CoNTRACTS AT 31 dECEmBER 2008
Date of Unexpired term at Notice
Executive Director
1
service contract 31 December 2008 period
David Brennan 1 January 2006 12 months 12 months
John Patterson 1 January 2005 12 months 12 months
Simon Lowth 5 November 2007 12 months 12 months
1
None of the Executive Directors has any provision in their service contracts giving them a right to liquidated
damages or an automatic entitlement to bonus for the duration of their notice period.
The Chairman’s and the Deputy Chairman’s
annual fees are £325,000 and £100,000
respectively, and the annual fees applicable
to other Non-Executive Directors are set
out below.
The remainder of this Report was subject to
audit by KPMG Audit Plc.
AudIT
The Directors’ emoluments in 2008 and
the details of the Directors’ interests in the
Company’s Ordinary Shares disclosed in the
Directors’ Emoluments section on pages 182
to 188 have been audited by the Companys
external auditor.
NoN-EXECuTIVE dIRECToRS’ FEES
£
Basic Fee 60,000
Senior Non-Executive Director (an additional) 25,000
Membership of the Audit Committee or the Remuneration Committee 15,000
Chairman of the Audit Committee or the Remuneration Committee (an additional) 20,000
Membership of the Science Committee 10,000
Chairman of the Science Committee (an additional) 7,000
182
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
dIRECToRS’ EmolumENTS IN 2008
The aggregate remuneration, excluding pension contributions and the value of shares under option and shares subject to performance share
plan awards, paid to or accrued for all Directors of the Company for services in all capacities during the year ended 31 December 2008 was
£5.9m ($11.1m). The remuneration of individual Directors is set out below in sterling and US dollars. All salaries, fees, bonuses and other
benefits for Directors are established in sterling.
dIRECToRSREmuNERATIoN STERlING
Salary
Bonuses
Taxable Other payments Total Total Total
and fees Cash Shares
1
benefits and allowances 2008 2007 2006
£000 £000 £000 £000 £000 £000 £000 £000
Louis Schweitzer
2
303 303 260 260
David Brennan 973 863 432 21 217
3
2,506 2,150 2,663
John Patterson 540 348 174 14 5
4,5
1,081 982 1,007
Simon Lowth 550 469 235 7 43
4
1,304 172
Bo Angelin
2
63 63 21
John Buchanan
2
96 96 69 69
Jean-Philippe Courtois
2,6
58 58
Jane Henney
2
76 76 57 57
Michele Hooper
2
90 90 64 49
Rudy Markham
7
23 23
Håkan Mogren
2
100 100 100 100
Nancy Rothwell
2
80 80 54 30
John Varley
2
83 83 56 21
Marcus Wallenberg
2
53 53 40 40
Former Directors 463 1,382
Total 3,088 1,680 841 42 265 5,916 4,488 5,678
1
These figures represent that portion of the 2008 bonuses required to be deferred into shares to be held for a three-year period, as explained on page 178.
2
Fees applicable to all Non-Executive Directors increased during the year, effective from the AGM on 24 April 2008. The revised fees are set out on page 181 of this Report.
3
Relates to relocation allowances, a car allowance and cash payments in respect of dividends accrued on vesting of a 2005 US performance share plan award.
4
Relates to remaining cash following selection of benefits within AstraZeneca’s UK flexible benefits programme.
5
Includes a deduction of £11,000 ($21,000) in respect of member contributions to the AstraZeneca Defined Benefit Programme paid through salary sacrifice (see page 183).
6
Part year only as appointed Director on 18 February 2008.
7
Part year only as appointed Director on 12 September 2008.
dIRECToRS’ REmuNERATIoN – uS dollARS
Salary
Bonuses
Taxable Other payments Total Total Total
and fees Cash Shares
1
benefits and allowances 2008 2007 2006
$000 $000 $000 $000 $000 $000 $000 $000
Louis Schweitzer
2
567 567 520 475
David Brennan 1,822 1,616 809 39 406
3
4,692 4,300 4,865
John Patterson 1,011 652 326 26 9
4,5
2,024 1,965 1,839
Simon Lowth 1,030 878 440 13 81
4
2,442 345
Bo Angelin
2
118 118 42
John Buchanan
2
180 180 138 126
Jean-Philippe Courtois
2,6
109 109
Jane Henney
2
142 142 114 104
Michele Hooper
2
169 169 128 89
Rudy Markham
7
43 43
Håkan Mogren
2
187 187 200 183
Nancy Rothwell
2
150 150 108 56
John Varley
2
155 155 113 39
Marcus Wallenberg
2
99 99 80 73
Former Directors 929 2,526
Total 5,782 3,146 1,575 78 496 11,077 8,982 10,375
1
These figures represent that portion of the 2008 bonuses required to be deferred into shares to be held for a three-year period, as explained on page 178.
2
Fees applicable to all Non-Executive Directors increased during the year, effective from the AGM on 24 April 2008. The revised fees are set out on page 181 of this Report.
3
Relates to relocation allowances, a car allowance and cash payments in respect of dividends accrued on vesting of a 2005 US performance share plan award.
4
Relates to remaining cash following selection of benefits within AstraZeneca’s UK flexible benefits programme.
5
Includes a deduction of $21,000 (£11,000) in respect of member contributions to the AstraZeneca Defined Benefit Programme paid through salary sacrifice (see page 183).
6
Part year only as appointed Director on 18 February 2008.
7
Part year only as appointed Director on 12 September 2008.
183
remuneration report
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
In the tables on this page and on the previous page, salaries have been converted between sterling and US dollars at the average exchange
rate for the year in question. These rates were:
GBP/USD
2006 0.547
2007 0.500
2008 0.534
The Executive Directors were also granted options to subscribe for Ordinary Shares and awards of Ordinary Shares under the Company’s
long-term incentive arrangements (the AstraZeneca Share Option Plan and the AstraZeneca Performance Share Plan). Details of share options
granted to, and exercised by, Directors and the aggregate of gains realised on the exercise of options, and of awards under the long-term
incentive plans, in the year are given on pages 185 to 188.
No Director has a family relationship with any other Director.
pENSIoNS
dEFINEd BENEFIT ARRANGEmENTS
Pensions are payable to Directors in sterling, with the exception of David Brennan’s, whose pension is payable in US dollars. For ease
of understanding, the table below has been presented in both sterling and US dollars using the exchange rates for 2008 set out on the
previous page.
David John David John
Brennan Patterson Brennan Patterson
£000 £000 $000 $000
Defined Benefit Arrangements
1. Accrued pension at 1 January 2008 611 335 1,145 627
2. Increase in accrued pension during year as a result of inflation 17 32
3. Adjustment to accrued pension as a result of salary increase relative to inflation 57 7 107 13
4. Increase in accrued pension as a result of additional service 12 6 23 11
5. Accrued pension at 31 December 2008 680 365 1,275 683
6. Employee contributions during 2008
7. Transfer value of accrued pension at 31 December 2007 5,325 6,833 9,973 12,797
8. Transfer value of accrued pension at 31 December 2008 9,313 8,288 17,441 15,521
9. Change in transfer value during the period less employee contributions 3,988 1,455 7,468 2,724
10. Age at 31 December 2008 55
3
12 60
11
12 55
3
12 60
11
12
11. Pensionable service (years) as at 31 December 2008 33 33
7
12 33 33
7
12
Notes
> For John Patterson, transfer values are calculated on the market related basis used by the AstraZeneca UK Pension Plan, in line with the GN11 guidance note published
by the Board for Actuarial Standards in the UK. The basis was reviewed during 2008 and this resulted in an increase in his transfer value of £993,000 ($1,860,000).
> For David Brennan, transfer values are calculated to be consistent with the value of the lump sum distribution equivalent to his deferred accrued pension annuity.
The minimum permissible value of such a lump sum distribution was modified in 2008.
> As described on page 176, David Brennan reached age 55 during 2008 at which point he became entitled to receive his benefits immediately on retirement without
reduction for payment before normal pension age. This results in a recalculation of his transfer value, which is reflected in this table for 2008. The figures shown above
reflect David Brennan’s participation in the AstraZeneca US Defined Benefit Pension Plan (qualified and non-qualified pension plans).
> For John Patterson, member contributions of £11,000 ($21,000), being 4% of pensionable salary for the first half of 2008 before he opted for cash in lieu, are paid
through salary sacrifice, and as such no employee contributions are shown above or included within emoluments.
dEFINEd CoNTRIBuTIoN ARRANGEmENTS
In addition to the defined benefit arrangements above for David Brennan, an employer matching contribution of £49,000 ($91,000) was made
to his 401(k) plan and associated non-qualified plan during 2008.
In addition to the defined benefit arrangements described above for John Patterson, as described on page 177, he has chosen to receive a
cash allowance in lieu of pension, which during the second half of 2008 amounted to £84,000 ($157,000).
Simon Lowth joined the Board on 5 November 2007. As described on page 177, he has chosen to receive a cash allowance in lieu of pension,
which during 2008 amounted to £132,000 ($247,000).
TRANSACTIoNS WITH dIRECToRS
There were no material recorded transactions between the Company and the Directors during 2008 or 2007.
75
100
125
150
175
JAN 04 JAN 05 JAN 06 JAN 08JAN 07 JAN 09
ASTRAZENECA
PHARMA PEERS AVERAGE FTSE 100
-30
-20
-10
0
10
20
30
40
50
ABT MRK BMS AZ
4th
J&J GSK RCH NOV PFI WYE SP LLY SA
-40
-30
-20
-10
0
10
20
ABT J&J GSK BMS AZ
5th
NOV RCH WYE SA SP PFI MRK LLY
-50
-40
-30
-20
-10
0
10
20
AZ
1st
ABT GSK J&J NOV RCH SA PFI BMS WYE LLY SP MRK
184
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
ToTAl SHAREHoldER RETuRN GRApHS
The UK Directors’ Remuneration Report
Regulations 2002 require the inclusion in the
Directors’ Remuneration Report of a graph
showing total shareholder return (TSR) over
a five year period in respect of a holding of
the Company’s shares, plotted against TSR
in respect of a hypothetical holding of shares
of a similar kind and number by reference
to which a broad equity market index is
calculated. The Company is a member of
the FTSE 100 Index and consequently, for
the purposes of this graph, which is set out
opposite, we have selected the FTSE 100
Index as the appropriate index. This graph
is re-based to 100 at the start of the rolling
five-year period. We have also included a
‘Pharma Peers Average’, which reflects the
TSR of the same comparator group used for
the Performance Share Plan graphs opposite.
The AstraZeneca Performance Share Plan
(PSP) referred to on page 179 requires that the
TSR in respect of a holding of the Company’s
shares over the relevant performance period
be compared with the TSR of a peer group
of 12 other pharmaceutical companies. The
graphs opposite show how the Company’s
TSR performance has compared with the
TSR for the companies in the comparator
group from the first day in the relevant
three-year performance period in respect of
each Award to 31 December 2008 and how
the Company ranks against those other
companies on this basis.
To alleviate any short-term volatility, the return
index is averaged in the TSR calculations for
each company over the three months prior to
the start of the relevant performance period
(as stipulated in the PSP) and, for the
purposes of the graphs opposite, over the
last three months of 2008.
TSR oVER A FIVE YEAR pERIod
TSR – ASTRAZENECA CompAREd WITH pEER GRoup 1 JAN 2006 To 31 dEC 2008
(FoR THE 2006 AWARd)
TSR – ASTRAZENECA CompAREd WITH pEER GRoup 1 JAN 2007 To 31 dEC 2008
(FoR THE 2007 AWARd)
TSR – ASTRAZENECA CompAREd WITH pEER GRoup 1 JAN 2008 To 31 dEC 2008
(FoR THE 2008 AWARd)
185
remuneration report
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
dIRECToRS’ INTERESTS IN SHARES
BENEFICIAl INTERESTS
The table below shows the interests at 31 December 2008 or on the date of resignation (if earlier) of the persons who on that date were
Directors (including the interests of their Connected Persons, as such term is defined in the Companies Act 2006) in shares and debentures
of AstraZeneca PLC. All such interests were beneficial except as otherwise stated. However, interests in Ordinary Shares or ADSs that are the
subject of awards under the AstraZeneca PSP, the AstraZeneca Deferred Bonus Plan or the AstraZeneca US Executive Performance Share
Plan discussed elsewhere, are not included in the table below but are shown on page 186 to page 187. None of the Directors has a beneficial
interest in the shares of any of the Company’s subsidiaries. Between 31 December 2008 and 29 January 2009 there was no change in the
interests in shares and debentures shown in the table below.
Beneficial Interest in Ordinary Shares Beneficial Interest in Ordinary Shares
Director at 1 January 2008 or (if later) appointment date Change to beneficial interest at 31 December 2008 or (if earlier) resignation date
Louis Schweitzer 4,000 4,000
Håkan Mogren 62,164 62,164
David Brennan 115,644 (2,796)
1
112, 84 8
2
Simon Lowth 850 850
John Patterson 8,015 625 8,640
Bo Angelin 500 500
John Buchanan 2,500 2,500
Jean-Philippe Courtois
3
500 500
Jane Henney 500 500
Michele Hooper 500 500
Rudy Markham
4
1,137 1,137
Nancy Rothwell 500 500
John Varley 500 500
Marcus Wallenberg 67,264 67,264
1
This figure represents the difference between the net number of ADSs acquired by David Brennan from the vesting of his 2005 award under the US Executive
Performance Share Plan and the net reduction in his notional beneficial interest in ADSs held within the unitised stock plans (see separate tables and footnotes below).
2
The total number of Ordinary Shares and ADSs in which David Brennan has an interest (including potential interests in unreleased shares held in Company plans
as detailed in the tables below) has increased in 2008 by 147,683 to 508,822 as at 31 December 2008.
3
Part year only as appointed Director on 18 February 2008.
4
Part year only as appointed Director on 12 September 2008.
uNITISEd SToCK plANS
David Brennan, in common with other participating executives in the US, has interests awarded to him prior to him becoming Chief Executive
Officer in the following: the AstraZeneca Executive Deferral Plan, the AstraZeneca Executive Deferred Compensation Plan and the AstraZeneca
Savings and Security Plan. These are unitised stock plans into which the value of certain previous share incentive awards has been deferred (and
are not incentive awards in their own right). Participants hold units in each plan, which represents a long-term equity interest in the Company.
A unit comprises part cash and part ADSs. The overall unit value can be determined daily by taking the market value of the underlying ADSs
and adding the cash position. The ADSs held within these units carry both voting and dividend rights. David Brennan is deemed to have a
notional beneficial interest in these ADSs, calculated by reference to the fund value and the closing price of ADSs. Therefore, the number of
ADSs in which a notional beneficial interest arises can vary daily as a consequence of stock price movements.
ADSs held at Net ADSs ADSs held at
Unitised stock plan 1 Jan 2008 acquired/(disposed) during 2008 31 Dec 2008
AstraZeneca Executive Deferral Plan 63,789 (22,849)
1
40,940
AstraZeneca Executive Deferred Compensation Plan 30,382 1,621 32,003
AstraZeneca Savings and Security Plan 6,983 717 7,700
1
This figure relates to a scheduled distribution in February 2008.
No Director or senior executive beneficially owns, or has options over, 1% or more of the outstanding shares of the Company, nor do they have
different voting rights to other shareholders.
186
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
ASTRAZENECA pERFoRmANCE SHARE plAN
The interests of Directors at 31 December 2008 in shares that are the subject of Awards under the AstraZeneca Performance Share Plan are
not included in the table on the previous page but are shown below:
Award Numbers of shares Award price Grant date
1
Vesting date
1
Performance period
1
David Brennan
2006 Award 73,109 2975p 24.03.06 24.03.09 01.01.06 – 31.12.08
2006 Award 19,092 2848p 19.05.06 19.05.09 01.01.06 – 31.12.08
2007 Award 107,051 2744p 30.03.07 30.03.10 01.01.07 – 31.12.09
Total at 1 Jan 2008 199,252
2008 Award 161,546 1882p 28.03.08 28.03.11 01.01.08 – 31.12.10
Total at 31 Dec 2008 360,798
John Patterson
2005 Award 41,945 2241p 29.06.05 29.06.08 01.01.05 – 31.12.07
2006 Award 32,319 2975p 24.03.06 24.03.09 01.01.06 – 31.12.08
2007 Award 36,785 2744p 30.03.07 30.03.10 01.01.07 – 31.12.09
Total at 1 Jan 2008 111,049
Lapse of 2005 Award (41,945)
2008 Award 57,385 1882p 28.03.08 28.03.11 01.01.08 – 31.12.10
Total at 31 Dec 2008 126,489
Simon Lowth
2007 Award 15,554 2210p 16.11.07 16.11.10 01.01.07 – 31.12.09
Total at 1 Jan 2008 15,554
2008 Award 58,448 1882p 28.03.08 28.03.11 01.01.08 – 31.12.10
Total at 31 Dec 2008 74,002
1
UK date convention applies.
uS EXECuTIVE pERFoRmANCE SHARE plAN
The interests of David Brennan at 31 December 2008 in ADSs of AstraZeneca PLC that are the subject of awards under the AstraZeneca
US Executive Performance Share Plan (established in 2000) are not included in the above tables but are shown below. One ADS equals one
Ordinary Share. The number of ADSs to which David Brennan may become unconditionally entitled on the vesting date will be determined
by reference to AstraZeneca’s total shareholder return compared with that of other companies in the US Pharmaceutical Human Resources
Association over the three year performance period from the date of first award.
Award Number of ADSs Award price Grant date
1
Vesting date
1
Performance period
1
David Brennan
2005 Award 27,877 $40.35 24.03.05 24.03.08 01.01.05 – 31.12.07
Total at 1 Jan 2008 27,877
Partial vesting of 2005 Award
2
(26,762)
3
Partial lapse of 2005 Award (1,115)
Total at 31 Dec 2008
1
UK date convention applies.
2
Vesting of 2005 Award was paid out in the form of ADSs. The ADS price on the vesting date was $37.63.
3
Following certain mandatory tax deductions, David Brennan became beneficially interested in a net number of 17,715 ADSs.
dEFERREd BoNuS plAN
There is a requirement for SET members, including the Executive Directors, to defer a proportion of their bonus and to use it to acquire Ordinary
Shares in the Company purchased on the market at the prevailing market price for a period of three years from the date on which the shares
were first acquired. The proportion currently deferred into Ordinary Shares is one third of the pre-tax bonus for Executive Directors and one sixth
for all other SET members. The interests of Directors and former Directors at 31 December 2008, or on the date of resignation (if earlier), in
Ordinary Shares that are the subject of awards under these arrangements are not included in the table on the previous page but are shown opposite:
8831_AZ_AR08_p173-188_v03_13_02_JF.indd 186 26/2/09 15:22:22
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remuneration report
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
Award Number of shares Award price Grant date
1
Vesting date
1
David Brennan
2006 Award 6,352 2639p 24.02.06 24.02.09
2007 Award 12,014 2911p 23.02.07 23.02.10
Total at 1 Jan 2008 18,366
2008 Award 16,810 1999p 25.02.08 25.02.11
Total at 31 Dec 2008 35,176
John Patterson
2006 Award 6,623 2639p 24.02.06 24.02.09
2007 Award 5,600 2911p 23.02.07 23.02.10
Total at 1 Jan 2008 12,223
2008 Award 7,810 1999p 25.02.08 25.02.11
Total at 31 Dec 2008 20,033
Simon Lowth
Total at 1 Jan 2008
2008 Award 1,340 1999p 25.02.08 25.02.11
Total at 31 Dec 2008 1,340
1
UK date convention applies.
SHARE opTIoNS
The interests of Directors, and of former Directors who served during 2008, in options to subscribe for Ordinary Shares in the Company, which
include options granted under the AstraZeneca Share Option Plan, the AstraZeneca Savings-Related Share Option Plan and the 1994 Executive
Share Option Scheme, together with options granted and exercised during 2008, are included in the following table. All grants in 2008 were made
under the AstraZeneca Share Option Plan, unless otherwise indicated.
Number of Ordinary Exercise price per Market price at First day Last day
Shares under option Ordinary Share
1
date of exercise exercisable
2, 3
exercisable
2,3
Håkan Mogren At 1 Jan 2008 244,896 2848p 13.12.02 24.03.13
– market price above option price N/A N/A N/A
– market price at or below option price 244,896 2848p 13.12.02 24.03.13
At 31 Dec 2008 244,896 2848p 13.12.02 24.03.13
– market price above option price 139,530 2499p 13.12.02 24.03.13
– market price at or below option price 105,366 3309p 23.08.03 27.03.12
David Brennan At 1 Jan 2008 – options over ADSs 355,246 $45.22 16.03.03 23.03.15
At 1 Jan 2008 – options over Ordinary Shares 239,103 2839p 24.03.09 29.03.17
– market price above option price (ADSs) 110,987 $40.35 24.03.08 23.03.15
– market price above option price (Ordinary Shares) N/A N/A N/A
– market price at or below option price (ADSs) 244,259 $47.44 16.03.03 25.03.14
– market price at or below option price (Ordinary Shares) 239,103 2839p 24.03.09 29.03.17
Granted 193,856 1882p 28.03.11 27.03.18
At 31 Dec 2008 – options over ADSs 355,246 $45.22 16.03.03 23.03.15
At 31 Dec 2008 – options over Ordinary Shares 432,959 2410p 24.03.09 27.03.18
– market price above option price (ADSs) 110,987 $40.35 24.03.08 23.03.15
– market price above option price (Ordinary Shares) 322,318 2226p 30.03.10 27.03.18
– market price at or below option price (ADSs) 244,259 $47.44 16.03.03 25.03.14
– market price at or below option price (Ordinary Shares) 110,641 2949p 24.03.09 18.05.16
Simon Lowth At 1 Jan 2008 18,665 2210p 16.11.10 15.11.17
– market price above option price N/A N/A N/A
– market price at or below option price 18,665 2210p 16.11.10 15.11.17
Gr an ted 70,13 8 18 82p 28.03.11 27.03.18
At 31 Dec 2008 88,803 1951p 16.11.10 27.03.18
– market price above option price 88,803 1951p 16.11.10 27.03.18
– market price at or below option price N/A N/A N/A
John Patterson At 1 Jan 2008 237,159 2735p 25.03.02 29.03.17
– market price above option price 53,282 2129p 01.12.07 23.03.15
– market price at or below option price 183,877 2911p 25.03.02 29.03.17
Granted 68,862 1882p 28.03.11 27.03.18
Exercised 374 1756p 2110p 01.12.07 31.05.08
Exercised 251 2262p 2110p 01.12.07 31.05.08
At 31 Dec 2008 305,396 2544p 25.03.02 27.03.18
– market price above option price 213,606 2279p 25.03.02 27.03.18
– market price at or below option price 91,790 3163p 23.08.03 23.03.16
1
Exercise prices at 1 January and 31 December are weighted averages.
2
First and last exercise dates of groups of options, within which period there are shorter exercise periods.
3
UK date convention applies.
188
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
GAINS BY dIRECToRS oN EXERCISE oF SHARE opTIoNS
The aggregate amount of gains made by Directors on the exercise of share options during the year and the two previous years is set out below.
Gains made by Directors on Gains made by
the exercise of share options the highest paid Director
Year $ $
2008 1,764.96
2007 783,858.08
2006 2,962,173.19 2,212,636.27
During 2008, the market price of shares in the Company was as follows:
Share market price as Range of the share
Stock Exchange at 31 December 2008 market price during 2008
London 2807p 1748p to 2888p
Stockholm 307.00 SEK 211.50 SEK to 340.50 SEK
New York $41.03 $34.10 to $49.85
The Register of Directors’ Interests (which is open to inspection) contains full details of Directors’ shareholdings and options to subscribe for
Ordinary Shares.
On behalf of the Board
A C N KEmp
Company Secretary
29 January 2009
ADDITIONAL INfOrmATION
190
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
SHArEHOLDEr INfOrmATION
AstraZeneca 2004 2005 2006 2007 2008
Ordinary Shares in issue – millions
At year end 1,645 1,581 1,532 1,457 1,447
Weighted average for year 1,673 1,617 1,564 1,495 1,453
Stock market price – per $0.25 Ordinary Share
Highest (pence) 2749 2837 3529 2984 2888
Lowest (pence) 1863 1861 2574 2093 1748
At year end (pence) 1889 2829 2744 2164 2807
pERCENTAgE ANAlySIS AT 31 dECEmbER 2008 oF ISSuEd ShARE CApITAl
By size of account 2008
No. of shares
%
1 – 250 0.5
251 – 500 0.7
501 – 1,000 0.9
1,001 – 5,000 1.2
5,001 – 10,000 0.2
10,001 – 50,000 1.0
50,001 – 1,000,000 13.6
Over 1,000,000
1
81.9
Issued share capital 100.0
1
Includes VPC and ADR holdings.
At 31 December 2008, AstraZeneca PLC had 135,790 registered holders of 1,447,481,548 Ordinary Shares of $0.25 each. At 31 December
2008, there were approximately 52,000 holders of American Depositary Receipts (ADRs) representing 7.36% of the issued share capital and
146,000 holders of shares held under the VPC Services Agreement representing 17.83% of the issued share capital. The ADRs, each of which
is equivalent to one Ordinary Share, are issued by JPMorgan Chase Bank.
ASTRAZENECA plC
Since April 1999, following the AstraZeneca merger, the principal markets for trading in the shares of AstraZeneca PLC are the London,
Stockholm and New York Stock Exchanges. The table below sets out, for the four quarters of 2007 and for the first two quarters and last
six months of 2008 the reported high and low share prices of AstraZeneca PLC, on the following bases:
For shares listed on the London Stock Exchange (LSE) the reported high and low middle market closing quotations are derived from >
The Daily Official List.
For shares listed on the Stockholm Stock Exchange (SSE) the high and low closing sales prices are as stated in the Official List. >
For American Depositary Shares (ADS) listed on the New York Stock Exchange the reported high and low sales prices are as reported by Dow >
Jones (ADR quotations).
Ordinary LSE ADS Ordinary SSE
1
High Low High Low High Low
(pence) (pence) (US$) (US$) (SEK) (SEK)
2007 – Quarter 1 2984 2734 58.78 53.53 414.0 367.5
– Quarter 2 2953 2567 59.04 51.00 401.0 354.5
– Quarter 3 2770 2278 56.16 45.56 374.5 315.0
– Quarter 4 2589 2093 52.47 42.82 343.5 272.0
2008 – Quarter 1 2345 1748 45.70 35.50 296.5 211.5
– Quarter 2 2289 1981 44.57 39.36 268.0 235.5
– July 2468 2130 48.55 43.42 292.0 255.5
– August 2693 2437 49.85 47.55 314.0 292.0
– September 2766 2415 48.95 43.53 321.5 292.5
– October 2630 2075 44.76 36.50 320.0 253.5
– November 2888 2245 44.38 34.10 340.5 280.5
– December 2807 2420 41.12 35.24 326.0 300.0
1
Principally held in bearer form.
ADDITIONAL INfOrmATION
191
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
During 2008, AstraZeneca’s share re-purchase programme, which was introduced in 1999, continued with the re-purchase and subsequent
cancellation of 13.6 million shares at a total cost of $610m, representing 0.9% of the total issued share capital of the Company. The average
price paid per share in 2008 was 2397 pence. This brings the total number of shares repurchased to date since the beginning of the re-purchase
programme in 1999, to 376.3 million Ordinary Shares (at an average price of 2661 pence per share) for a consideration, including expenses,
of $18,099m. The excess of the consideration over the nominal value was charged against the profit and loss account reserve. Shares issued
in respect of share schemes totalled 4.1 million.
In 1999, in connection with the merger, AstraZeneca’s share capital was redenominated in US dollars. On 6 April 1999, Zeneca shares were
cancelled and US dollar shares issued, credited as fully paid on the basis of one dollar share for each Zeneca share then held. This was achieved
by a reduction of capital under section 135 of the Companies Act 1985. Upon the reduction of capital becoming effective, all issued and
unissued Zeneca shares were cancelled and the sum arising as a result thereof credited to a special reserve, which was converted into US dollars
at the rate of exchange prevailing on the record date. This US dollar reserve was then applied in paying up, at par, newly created US dollar shares.
At the same time as the US dollar shares were issued, the Company issued 50,000 Redeemable Preference Shares with a nominal value of
£1.00 each for cash at par. The Redeemable Preference Shares carry limited class voting rights and no dividend rights. This class of shares is
also capable of redemption at par at the option of the Company on the giving of seven days’ written notice to the registered holder of the shares.
A total of 826 million AstraZeneca shares were issued to Astra shareholders who accepted the merger offer before the final closing date,
21 May 1999. AstraZeneca received acceptances from Astra shareholders representing 99.6% of Astra’s shares and the remaining 0.4%
was acquired in 2000 for cash.
mAjoR ShAREholdINgS
At 29 January 2009, the following had disclosed an interest in the issued Ordinary Share capital of the Company in accordance with the
requirements of section 5.1.2 of the UK Listing Authority’s Disclosure and Transparency Rules:
Date of Percentage
disclosure of issued
Shareholder Number of shares to Company
1
share capital
Capital Research and Management Company 71,261,060 25 Jun 2007 4.92%
Axa SA 70,934,559 20 Dec 2007 4.90%
Investor AB 63,465,810 11 Feb 2004 4.38%
Barclays PLC 61,721,820 18 Dec 2006 4.26%
Wellington Management Co., LLP 60,565,299 30 Oct 2006 4.18%
Legal & General Investment Management Limited 59,198,535 12 Sept 2007 4.09%
1
Since the date of disclosure to the Company, the interest of any person listed above in the Ordinary Shares of the Company may have increased or decreased.
No requirement to notify the Company of any increase or decrease would have arisen unless the holding moved up or down through a whole number percentage
level. The percentage level may increase (on the cancellation of shares following a re-purchase of shares under the Company’s share re-purchase programme)
or decrease (on the issue of new shares under any of the Company’s share plans).
No other person held a notifiable interest in shares, comprising 3% or more of the issued Ordinary Share capital of the Company.
Changes in the percentage ownership held by major shareholders during the past three years are set out below. Major shareholders do not
have different voting rights.
Percentage of issued share capital
Shareholder 29 Jan 2009 31 Jan 2008 31 Jan 2007 31 Jan 2006
Capital Research and Management Company 4.92% 4.89% 11.70% 12.57%
Axa SA 4.90% 4.87%
Investor AB 4.38% 4.36% 4.14% 4.01%
Barclays PLC 4.26% 4.24% 4.03% 3.20%
Wellington Management Co., LLP 4.18% 4.16% 3.95% 4.97%
Legal & General Investment Management Limited 4.09% 4.06% 3.43% 3.32%
AstraZeneca PLC American Depositary Shares (each representing one Ordinary Share) evidenced by American Depositary Receipts issued
by JPMorgan Chase Bank, as depositary, are listed on the New York Stock Exchange. At 29 January 2009, the proportion of Ordinary Shares
represented by American Depositary Shares was 7.20% of the Ordinary Shares outstanding.
192
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
mAjoR ShAREholdINgS CoNTINuEd
Number of registered holders of Ordinary Shares at 29 January 2009:
> In the US 794
> Total 128,748
Number of record holders of American Depositary Receipts at 29 January 2009:
> In the US 2,296
> Total 2,330
So far as the Company is aware, it is neither directly nor indirectly owned nor controlled by one or more corporations or by any government.
At 29 January 2009, the total amount of the Company’s voting securities owned by Directors and Officers of the Company was:
Percentage
Title of class Amount owned of class
Ordinary Shares 294,034 0.02%
The Company does not know of any arrangements, the operation of which might result in a change in the control of the Company.
RElATEd pARTy TRANSACTIoNS
During the period 1 January 2009 to 29 January 2009, there were no transactions, loans, or proposed transactions between the Company and
any related parties which were material to either the Company or the related party, or which were unusual in their nature or conditions (see also
Note 27 to the Financial Statements).
opTIoNS To puRChASE SECuRITIES FRom REgISTRANT oR SubSIdIARIES
(a) At 29 January 2009, options outstanding to subscribe for Ordinary Shares of $0.25 of the Company were:
Number of shares Subscription price Normal expiry date
55,640,140 1882p – 3487p 2009 – 2018
The weighted average subscription price of options outstanding at 29 January 2009 was 2519p. All options were granted under Company
employee share schemes.
(b) Included in paragraph (a) are options granted to Directors and Officers of AstraZeneca as follows:
Number of shares Subscription price Normal expiry date
2,428,727 1882p – 3487p 2009 – 2018
(c) Included in paragraph (b) are options granted to individually named Directors. Details of these option holdings at 31 December 2008 are
shown in the Directors’ Remuneration Report.
During the period 1 January 2009 to 29 January 2009, no Director exercised any options.
dIvIdENd pAymENTS
For Ordinary Shares listed on the London and Stockholm Stock Exchanges and ADRs listed on the New York Stock Exchange, the record date
for the second interim dividend for 2008, payable on 16 March 2009, is 6 February 2009 and the ex-dividend date is 4 February 2009.
The record date for the first interim dividend for 2009, payable on 14 September 2009, is 7 August 2009.
Future dividends will normally be paid as follows:
First interim: Announced in July and paid in September.
Second interim: Announced in January and paid in March.
ADDITIONAL INfOrmATION
193
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
ShAREvIEw
AstraZeneca’s shareholders with internet
access may visit shareview.co.uk and register
their details to create a portfolio. Shareview
is a free and secure on-line service from the
Company’s registrars, Equiniti Limited, which
gives access to shareholdings including
balance movements, indicative share prices
and information about recent dividends.
ShAREgIFT
AstraZeneca welcomes and values all of its
shareholders, no matter how many or how
few shares they own. However, shareholders
who have only a small number of shares whose
value makes it uneconomic to sell them,
either now or at some stage in the future, may
wish to consider donating them to charity
through ShareGift, an independent charity
share donation scheme. One feature of the
scheme is that there is no gain or loss for UK
capital gains tax purposes on gifts of shares
through ShareGift, and it may now also be
possible to obtain UK income tax relief on the
donation. Further information about ShareGift
can be found on its website, sharegift.org, or
by contacting ShareGift on 020 7930 3737
or at 17 Carlton House Terrace, London
SW1Y 5AH. More information about the UK
tax position on gifts of shares to ShareGift can
be obtained from HM Revenue & Customs,
whose website address is hmrc.gov.uk.
The share transfer form needed to make
a donation may be obtained from the
Company’s registrars, Equiniti Limited, whose
address can be found on the back cover of
this document. ShareGift is administered by
The Orr Mackintosh Foundation, registered
charity number 1052686.
ThE uNClAImEd ASSETS REgISTER
AstraZeneca supplies unclaimed dividend
data to the Unclaimed Assets Register (UAR),
which provides investors who have lost track
of shareholdings with an opportunity to search
the UARs database of unclaimed financial
assets on payment of a small, fixed fee. The
UAR donates part of the search fee to charity.
The UAR can be contacted on 0870 241 1713
or at PO Box 9501, Nottingham NG80 1WD.
RESulTS
Unaudited trading results of AstraZeneca in
respect of the first three months of 2009 will
be published on 30 April 2009 and results in
respect of the first six months of 2009 will be
published on 30 July 2009.
doCumENTS oN dISplAy
The Memorandum and Articles of Association
of the Company and other documents
concerning the Company which are referred
to in this document may be inspected at the
Company’s registered office at 15 Stanhope
Gate, London W1K 1LN.
TAxATIoN FoR uS RESIdENTS
The following summary of the material UK
and US federal income tax consequences of
ownership of Ordinary Shares or ADRs held
as capital assets by US resident shareholders
is based on current UK and US federal income
tax law, including the US/UK double taxation
convention relating to income and capital gains,
which entered into force on 31 March 2003
(the Convention). This discussion is also based
in part on representations of JPMorgan Chase
Bank as depositary for ADRs and assumes
that each obligation in the deposit agreement
among the Company, the depositary and
the holders from time to time of ADRs and
any related agreements will be performed in
accordance with its terms. The US Treasury
has expressed concerns that parties to whom
ADRs are pre-released may be taking actions
that are inconsistent with the claiming, by US
holders of ADRs, of foreign tax credits for US
federal income tax purposes. Such actions
would also be inconsistent with the claiming
of the reduced tax rate, described below,
applicable to dividends received by certain
non-corporate US resident shareholders.
Accordingly, the availability of the reduced tax
rate for dividends received by certain
non-corporate US resident shareholders could
be affected by actions that may be taken by
parties to whom ADRs are pre-released.
This discussion assumes that we are not, and
will not become, a passive foreign investment
company (PFIC), as discussed below.
uK ANd uS INComE TAxATIoN oF dIvIdENdS
The UK does not currently impose a
withholding tax on dividends paid by
a UK company, such as the Company.
For US federal income tax purposes,
distributions paid by the Company to a US
resident shareholder are included in gross
income as foreign source ordinary dividend
income to the extent of the Company’s
current or accumulated earnings and profits,
calculated in accordance with US federal
income tax principles. The amount of the
dividend will be the US dollar amount
received by the depositary for US resident
holders of ADRs (or in the case of Ordinary
Shares, the US dollar value of the pounds
sterling on the date the dividend is received
by the US resident shareholders, regardless
of whether the dividend is converted into
US dollars), and it will not be eligible for
the dividends received deduction generally
available to US corporations. If the dividend
is converted into US dollars on the date
of receipt, US resident holders of Ordinary
Shares generally should not be required to
recognise foreign currency gain or loss in
respect of the dividend income. They may
have foreign currency gain or loss if the
amount of such dividend is not converted
into US dollars on the date of its receipt.
Subject to applicable limitations and the
discussion above regarding concerns
expressed by the US Treasury, dividends
received by certain non-corporate US
resident holders of Ordinary Shares or ADRs
in taxable years beginning before 1 January
2011 may be subject to US federal income
tax at a maximum rate of 15%. US resident
shareholders should consult their own tax
advisers to determine whether they are
subject to any special rules which may limit
their ability to be taxed at this favourable rate.
TAxATIoN oN CApITAl gAINS
Under the Convention, each contracting state
may in general tax capital gains in accordance
with the provisions of its domestic law. Under
present UK law, individuals who are neither
resident nor ordinarily resident in the UK, and
companies which are not resident in the UK,
will not be liable to UK tax on capital gains
made on the disposal of their Ordinary Shares
or ADRs, unless such Ordinary Shares or
ADRs are held in connection with a trade,
profession or vocation carried on in the UK
through a branch or agency.
194
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
TAxATIoN oN CApITAl gAINS CoNTINuEd
A US resident shareholder will generally
recognise US source capital gain or loss for
US federal income tax purposes on the sale
or exchange of Ordinary Shares or ADRs in
an amount equal to the difference between
the US dollar amount realised and such
holder’s US dollar adjusted tax basis in
the Ordinary Shares or ADRs. US resident
shareholders should consult their own tax
advisers about the treatment of capital gains,
which may be taxed at lower rates than
ordinary income for non-corporate US
resident shareholders and capital losses,
the deductibility of which may be limited.
pASSIvE FoREIgN INvESTmENT
CompANy RulES
We believe that we were not a passive
foreign investment company (PFIC) for US
federal income tax purposes for the year
ended 31 December 2008, and do not
expect to be a PFIC in the foreseeable future.
However, since PFIC status depends on the
composition of our income and assets and
the market value of our assets (including,
among others, less than 25%-owned equity
investments) from time to time, there can be
no assurance that we will not be considered
a PFIC for any taxable year. If we were treated
as a PFIC for any taxable year during which
Ordinary Shares or ADRs were held, certain
adverse tax consequences could apply to US
resident shareholders.
uK INhERITANCE TAx
Under the current Double Taxation (Estates)
Convention (the Estate Tax Convention)
between the US and the UK, Ordinary Shares
or ADRs held by an individual shareholder who
is domiciled for the purposes of the Estate
Tax Convention in the US, and is not for the
purposes of the Estate Tax Convention a
national of the UK, will generally not be subject
to UK inheritance tax on the individual’s death
or on a chargeable gift of the Ordinary Shares
or ADRs during the individual’s lifetime,
provided that any applicable US federal gift or
estate tax liability is paid, unless the Ordinary
Shares or ADRs are part of the business
property of a permanent establishment of the
individual in the UK or, in the case of
a shareholder who performs independent
personal services, pertain to a fixed base
situated in the UK. Where the Ordinary Shares
or ADRs have been placed in trust by a settlor
who, at the time of settlement, was a US
resident shareholder, the Ordinary Shares
or ADRs will generally not be subject to UK
inheritance tax unless the settlor, at the time of
settlement, was not domiciled in the US and
was a UK national. In the exceptional case
where the Ordinary Shares or ADRs are subject
to both UK inheritance tax and US federal gift
or estate tax, the Estate Tax Convention
generally provides for double taxation to be
relieved by means of credit relief.
uK STAmp duTy RESERvE TAx
ANd STAmp duTy
A 1.5% stamp duty reserve tax is payable upon
the deposit of Ordinary Shares in connection
with the creation of, but not subsequent
dealing in, ADRs. A 0.5% stamp duty is
payable on all purchases of Ordinary Shares.
ExChANgE CoNTRolS ANd oThER
lImITATIoNS AFFECTINg SECuRITy holdERS
There are no governmental laws, decrees
or regulations in the UK restricting the import
or export of capital or affecting the remittance
of dividends, interest or other payments to
non-resident holders of Ordinary Shares
or ADRs.
There are no limitations under English law
or the Company’s Memorandum and Articles
of Association on the right of non-resident or
foreign owners to be the registered holders of
and to vote Ordinary Shares or ADRs or to be
registered holders of notes or debentures of
Zeneca Wilmington Inc. or AstraZeneca PLC.
ADDITIONAL INfOrmATION
195
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
ExChANgE RATES
For the periods up to April 1999, Astra accounted for and reported its results in Swedish kronor, whereas Zeneca accounted for and reported
its results in sterling. Consistent with AstraZeneca’s decision to publish its Financial Statements in US dollars, the financial information in this
document has been translated from kronor and sterling into US dollars at the following applicable exchange rates:
SEK/USD USD/GBP
Average rates (profit and loss account, cash flow)
1995 7.1100 1.5796
1996 6.7000 1.5525
1997 7.6225 1.6386
1998 7.9384 1.6603
1999 8.2189 1.6247
End of year spot rates (balance sheet)
1995 6.6500 1.5500
1996 6.8400 1.6900
1997 7.8500 1.6600
1998 8.0400 1.6600
1999 8.5130 1.6185
The following information relating to average and spot exchange rates used by AstraZeneca is provided for convenience:
SEK/USD USD/GBP
Average rates (income statement, cash flow)
2006 7.4472 1.8265
2007 6.7692 2.0003
2008 6.5130 1.8728
End of year spot rates (balance sheet)
2006 6.8824 1.9626
2007 6.4051 1.9932
2008 7.7740 1.4437
196
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
dEFINITIoNS ANd INTERpRETATIoN
Figures in parentheses in tables and in the Financial Statements are used to represent negative numbers.
Except where otherwise indicated, figures included in this Report relating to pharmaceutical product market sizes and market shares are obtained
from syndicated industry sources, primarily IMS Health (IMS), a market research firm internationally recognised by the pharmaceutical industry.
The 2008 market share figures included in this report are based primarily on data obtained from an online IMS database.
IMS data may differ from that compiled by the Group with respect to its own products. Of particular significance in this regard are the following:
(1) AstraZeneca publishes its financial results on a financial year and quarterly interim basis, whereas IMS issues its data on a monthly and
quarterly basis; (2) the online IMS database is updated quarterly and uses the average exchange rates for the relevant quarter; (3) IMS data from
the US is not adjusted for Medicaid and similar state rebates; and (4) IMS sales data are compiled using actual wholesaler data and data from
statistically representative panels of retail and hospital pharmacies, which data are then projected by IMS to give figures for national markets.
References to prevalence of disease have been derived from a variety of sources and are not intended to be indicative of the current market
or any potential market for AstraZeneca’s pharmaceutical products since, among other things, there may be no correlation between the
prevalence of a disease and the number of individuals who are treated for such a disease.
Terms used in the Annual Report
and Form 20-F Information US equivalent or brief description
Accruals Accrued expenses
Allotted Issued
Bank borrowings Payable to banks
Called-up share capital Issued share capital
Creditors Liabilities/payables
Current instalments of loans Long term debt due within one year
Debtors Receivables and prepaid expenses
Earnings Net income
Finance lease Capital lease
Fixed asset investments Non-current investments
Freehold Ownership with absolute rights in perpetuity
Interest receivable Interest income
Interest payable Interest expense
Loans Long term debt
Prepayments Prepaid expenses
Profit Income
Profit and loss account Income statement/consolidated statement of income
Reserves Retained earnings
Short term investments Redeemable securities and short term deposits
Share premium account Premiums paid in excess of par value of Ordinary Shares
Statement of recognised income and expense Statement of comprehensive income
ADDITIONAL INfOrmATION
197
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
COrPOrATE INfOrmATION
hISToRy ANd dEvElopmENT
oF ThE CompANy
AstraZeneca PLC was incorporated in England
and Wales on 17 June 1992 under the
Companies Act 1985. It is a public limited
company domiciled in the UK. The Company’s
registered number is 2723534 and its
registered office is at 15 Stanhope Gate,
London W1K 1LN (telephone + 44 (0)20
7304 5000). From February 1993 until April
1999, the Company was called Zeneca
Group PLC. On 6 April 1999, the Company
changed its name to AstraZeneca PLC.
The Company was formed when the
pharmaceutical, agrochemical and specialty
chemical businesses of Imperial Chemical
Industries PLC were demerged in 1993.
In 1999, the Company sold the specialty
chemical business. Also in 1999, the Company
merged with Astra AB of Sweden. In 2000,
it demerged the agrochemical business and
merged it with the similar agribusiness of
Novartis AG to form a new company called
Syngenta AG.
The Company owns and operates numerous
R&D, production and marketing facilities
worldwide. Its corporate headquarters are
at 15 Stanhope Gate, London W1K 1LN.
mEmoRANdum ANd ARTIClES
oF ASSoCIATIoN
objECTS
As is typical of companies registered in
England and Wales, the Company’s objects,
which are detailed in the Memorandum of
Association, are broad and wide-ranging
and include manufacturing, distributing and
trading pharmaceutical products.
Any amendment to the Company’s Articles
of Association requires the approval of
shareholders at a general meeting of
the Company.
dIRECToRS
The Board has the authority to manage the
business of the Company, through powers
such as authorising the Company to allot and
re-purchase its shares. However, subject to
certain exceptions, Directors do not have
power to vote at Board meetings on matters
in which they have a material interest.
The quorum for meetings of the Board of
Directors is a majority of the full Board, of
whom at least four must be Non-Executive
Directors. In the absence of a quorum, the
Directors do not have power to determine
compensation arrangements for themselves
or any member of the Board.
The Board of Directors may exercise all the
powers of the Company to borrow money.
Variation of these borrowing powers would
require the passing of a special resolution
of the Company’s shareholders.
All Directors must retire from office at the
Companys AGM each year and may present
themselves for re-election. Directors are
not prohibited, upon reaching a particular
age, from submitting themselves for election
or re-election.
Within two months of the date of appointment,
Directors are required to beneficially own
Ordinary Shares in the Company of an
aggregate nominal amount of $125, which
currently represents at least 500 shares.
RIghTS, pREFERENCES ANd RESTRICTIoNS
ATTAChINg To ShARES
The share capital of the Company is divided
into 2,400,000,000 Ordinary Shares with
a nominal value of $0.25 each and 50,000
Redeemable Preference Shares with a nominal
value of £1.00 each. The rights and restrictions
attaching to the Redeemable Preference
Shares differ from those attaching to Ordinary
Shares as follows:
The Redeemable Preference Shares carry >
no rights to receive dividends.
The holders of Redeemable Preference >
Shares have no rights to receive notices
of, attend or vote at general meetings
except in certain limited circumstances.
They have one vote for every 50,000
Redeemable Preference Shares held.
On a distribution of assets of the Company, >
on a winding-up or other return of capital
(subject to certain exceptions), the holders
of Redeemable Preference Shares have
priority over the holders of Ordinary
Shares to receive the capital paid up on
those shares.
Subject to the provisions of the Companies >
Act 1985, the Company has the right
to redeem the Redeemable Preference
Shares at any time on giving not less
than seven days’ written notice.
ACTIoN NECESSARy To ChANgE ThE RIghTS
oF ShAREholdERS
In order to vary the rights attached to any
class of shares, the consent in writing of the
holders of three quarters in nominal value of
the issued shares of that class or the sanction
of an extraordinary resolution passed at a
general meeting of such holders is required.
gENERAl mEETINgS
Annual general meetings and other general
meetings, as from time to time may be
required, where a special resolution is to
be passed or a Director is to be appointed
require 21 clear days’ notice to shareholders.
All other general meetings require 14 clear
days’ notice.
For all general meetings, a quorum of two
shareholders present in person or by proxy,
and entitled to vote on the business
transacted, is required.
Shareholders and their duly appointed
proxies and corporate representatives are
entitled to be admitted to general meetings.
lImITATIoNS oN ThE RIghTS To owN ShARES
There are no limitations on the rights to
own shares.
198
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
CrOSS-rEfErENCE TO fOrm 20-f
ITEm pAgE
3 KEy INFoRmATIoN
A. Selected financial data
Financial Highlights 2
Directors’ Report –
Reporting Our Performance – Financial 15
Group Financial Record 172
Additional Information
Shareholder Information 190
D. Risk Factors
Risk – Principal Risks and Uncertainties 76
4 INFoRmATIoN oN ThE CompANy
A. History and development of the Company
Additional Information History and
development of the Company 197
Financial Review – Investments,
divestments and capital expenditure 41
Directors’ Report –
Supply and Manufacturing 27
Note 7 – Property, plant and equipment 114
Note 22 Acquisitions of business
operations 130
B. Business overview
Directors’ Report 7
C. Organisational structure
Directors’ Report Other Company
Disclosures and Information 94
Principal Subsidiaries 164
D. Property, plants and equipment
Directors’ Report – Our Resources 17
5 opERATINg ANd FINANCIAl REvIEw
ANd pRoSpECTS
A-F. Directors’ Report 7
Financial Review 31
Note 16 – Financial instruments 122
6 dIRECToRS, SENIoR mANAgEmENT
ANd EmployEES
A. Directors and senior management
Directors’ Report Board of Directors
at 31 December 2008 84
B. Compensation
Remuneration Report –
Directors’ Remuneration Report 174
Note 23 – Post-retirement benefits 133
Note 27 – Statutory and other information 163
The information in this document that is referenced on this page is included in AstraZeneca’s Form 20-F for 2008 (2008 Form 20-F) and is filed
with the Securities and Exchange Commission (SEC). The 2008 Form 20-F is the only document intended to be incorporated by reference into
any filings by AstraZeneca under the Securities Act of 1933, as amended. References to major headings include all information under such
major headings, including subheadings. References to subheadings include only the information contained under such subheadings. Graphs
are not included unless specifically identified. The 2008 Form 20-F has not been approved or disapproved by the SEC, nor has the SEC
passed comment upon the accuracy or adequacy of the 2008 Form 20-F. The 2008 Form 20-F filed with the SEC may contain modified
information and may be updated from time to time.
ITEm pAgE
6 dIRECToRS, SENIoR mANAgEmENT
ANd EmployEES CoNTINuEd
C. Board practices
Directors’ Report Board of Directors
at 31 December 2008 84
Remuneration Report –
Directors’ Remuneration Report 174
Directors’ Report –
Operation of the Board of Directors 87
Directors’ Report –
Operation of Board Committees 88
D. Employees
Note 24 – Employee costs and share option
plans for employees 138
Directors’ Report – People 28
E. Share ownership
Remuneration Report –
Directors’ Interests in Shares 185
Note 24 Employee costs and share
option plans for employees 138
7 mAjoR ShAREholdERS ANd RElATEd
pARTy TRANSACTIoNS
A. Major shareholders
Additional Information
Major Shareholdings 191
B. Related party transactions
Additional Information
Related Party Transactions 192
Note 27 – Statutory and other information 163
8 FINANCIAl INFoRmATIoN
A. Consolidated statements and
other financial information
Financial Statements (excluding
Directors’ responsibilities on page 98
and Auditor’s opinion on page 99) 97
B. Significant changes
Note 27 – Statutory and other information 163
9 ThE oFFER ANd lISTINg
A4. Price history of listed stock
Additional Information
Shareholder Information 190
C. Markets
Additional Information
Shareholder Information 190
ITEm pAgE
10 AddITIoNAl INFoRmATIoN
B. Memorandum and Articles of Association
Additional Information Memorandum
and Articles of Association 197
C. Material contracts n/a
D. Exchange controls
Additional Information Exchange Controls
and other Limitations affecting
Security Holders 194
E. Taxation
Financial Review – Taxation 46
H. Documents on display
Additional Information
Documents on Display 193
I. Subsidiary information
Principal Subsidiaries 164
11 QuANTITATIvE ANd QuAlITATIvE
dISCloSuRES AbouT mARKET RISK
Financial Review – Financial Risk
Management Policies 41
15 CoNTRolS ANd pRoCEduRES
Directors’ Report UK Corporate
Governance Requirements 91
16 [RESERvEd]
A. Audit Committee financial expert
Directors’ Report – Audit Committee 89
B. Code of ethics
Directors’ Report – Code of Conduct 93
C. Principal accountant fees and services
Note 27 – Statutory and other information 163
D. Exemptions from the listing standards for
audit committees n/a
E. Purchases of equity securities by the issuer
and affiliated purchasers
Note 20 – Share capital of parent company 129
G. Corporate Governance
Directors’ Report Principal UK and US
Governance Requirements 91
18 FINANCIAl STATEmENTS
Financial Statements (excluding Directors’
responsibilities on page 98 and Auditor’s
opinion on page 99) 97
ADDITIONAL INFORMATION
199
Emerging Markets means Emerging Rest of World.
Established Markets means North America and Established Rest of World.
IMS Data is not included for those countries listed in the lower table.
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
GLOSSARY
The following abbreviations and expressions have
the following meanings when used in this report:
abbreviated new drug application (ANDA)
A marketing approval application for a generic drug
submitted to the US Food and Drug Administration.
abbreviated new drug submission (ANDS)
A marketing approval application for a generic drug
submitted in Canada.
adjuvant An agent that modifies the effect of other
agents (for example drugs and vaccines) while having
few if any direct effects when given by itself; it
operates like a catalyst in chemical reactions.
ADR American Depositary Receipt evidencing title
to an ADS.
ADS American Depositary Share representing one
underlying Ordinary Share.
agonist A substance capable of binding to a
molecular target to trigger a response.
angiotensin II A hormone that causes blood vessels
to narrow and thereby raises blood pressure.
antagonist A substance capable of binding to a
molecular target to neutralise or counteract a reaction.
anti-cytokine monoclonal antibodies (MAbs)
A group of large molecule compounds which can
block interactions between cytokines and their
receptors. Cytokines are a class of signalling
molecule, used in cellular communication, similar
to hormones and neurotransmitters preventing
them from functioning
AstraZeneca AstraZeneca PLC and its subsidiaries.
biomarker A characteristic that can be measured
objectively and evaluated as an indicator of normal
biological, or pathogenic processes, or pharmacological
responses to a therapeutic intervention.
biopharmaceuticals/biologics A class of
medicines derived from proteins usually produced
naturally by living organisms in response to disease,
for example antibodies.
bipolar disorder Any of several mood disorders,
usually characterised by alternating episodes of
depression and mania or by episodes of depression
alternating with mild non-psychotic excitement.
bipolar I disorder A sub-set of bipolar patients who
have experienced one or more manic or mixed episodes.
biosimilars Follow-on biopharmaceuticals that are
biologically similar to an existing medicine.
BLA (Biological Licence Application) Granting
of the licence certifies that biological product is
safe, pure and potent; and the facility in which it
is manufactured meets standards designed to
ensure that it continues to be safe, pure and potent.
Board The Board of Directors of AstraZeneca PLC.
CAT Cambridge Antibody Technology Group plc.
CER Constant exchange rates.
Company AstraZeneca PLC.
Complete Response Letter A complete response
is now issued by the FDA when it has completed
its evaluation of a regulatory submission.
cost growth rates Percentage growth of a particular
cost category over the comparable cost category for
the previous year.
depositary JPMorgan Chase Bank, as depositary
under the deposit agreement pursuant to which the
ADRs are issued.
Director A director of the Company.
earnings per share (EPS) Profit for the year after
tax and minority interests, divided by the weighted
average number of Ordinary Shares in issue during
the year.
efficacy The beneficial effect of a drug refers to the
potential maximum therapeutic response that a drug
can produce.
EFPIA The European Federation of Pharmaceutical
Industries and Associations.
EMEA The European Medicines Agency.
Emerging Markets Emerging Rest of World, see
table above.
Established Markets North America and Established
Rest of World, see table above.
EU European Union.
finance income and expense This includes interest
earned and payable, and similar items.
first good laboratory practice (FGLP) The point
at which a compound undergoes the first pre-clinical
study that is required for regulatory approval;
this marks entry into the development pipeline.
first-line therapy Treatment given to a newly
diagnosed patient, who has therefore not yet been
treated; it is the initial treatment of a disease, sign
or symptom.
Food and Drug Administration (FDA) Part of the
US Department of Health and Human Services
Agency, which is the regulatory authority for all
pharmaceuticals (including biologics and vaccines)
and medical devices in the US.
generalised anxiety disorder (GAD) A neurotic
illness characterised by chronic and persistent
apprehension and tension.
gross margin The margin, as a percentage, by which
sales exceed the cost of sales, calculated by dividing
the difference between the two by the sales figure.
mARKET dEFINITIoNS TABlE
NoRTh AmERICA ESTABlIShEd REST oF WoRld EmERgINg REST oF WoRld
US Canada Western Europe
Japan Other Established
Emerging Europe China Emerging
Asia Pacific
Other Emerging
US Canada Austria
Belgium
Denmark
Finland
France
Germany
Greece
Holland
Italy
Norway
Portugal
Spain
Sweden
UK
Japan Australia
New Zealand
Czech Republic
Estonia
Latvia
Poland
Slovakia
Turkey
China
Hong Kong
India
Malaysia
Philippines
South Korea
Taiwan
Thailand
Algeria
Argentina
Brazil
Central America
Chile
Colombia
Egypt
Lebanon
Mexico
Morocco
Peru
Saudi Arabia
South Africa
UAE
Venezuela
Iceland
Luxembourg
Albania
Belarus
Bosnia-Herzegovina
Bulgaria
Croatia
Georgia
Hungary
Macedonia
Romania
Russia
Serbia/Montenegro
Afghanistan
Bangladesh
Brunei
Cambodia
Indonesia
Laos
Myanmar
Nepal
Papua New Guinea
Singapore
Sri Lanka
Vietnam
8831_AZ_AR08_p189-200_v03_13_02_JHC.indd 199 26/2/09 15:28:12
200
ASTRAZENECA ANNuAl REpoRT ANd FoRm 20-F INFoRmATIoN 2008
Group AstraZeneca PLC and its subsidiaries.
high-density lipoprotein cholesterol (HDL-C)
Cholesterol carried in the blood by HDL back to the
liver, sometimes referred to as ‘good’ cholesterol.
hsCRP A high-sensitivity C-Reactive Protein to
determine the potential risk for cardiovascular disease
(measures levels of C-Reactive Protein in the blood).
IAS International Accounting Standards.
IFRS International Financial Reporting Standards.
KPI Key performance indicator.
large molecule A general term used to describe
pharmaceutical R&D using biology and biological
methods and materials to discover and develop new
medicines. Biological molecules are large compared
with chemical molecules.
LIBID London Interbank Bid Rate.
low-density lipoprotein cholesterol (LDL-C)
Cholesterol that is carried in the blood by LDL,
sometimes referred to as ‘bad’ cholesterol.
LSE London Stock Exchange plc.
MAb (Monoclonal antibody) A large molecule that is
extremely specific; that is, it binds to and attacks one
particular antigen.
major depressive disorder (MDD) Depression where
five or more symptoms of depression are present for
at least two weeks.
marketing authorisation application (MAA)
An application for authorisation to place medical
products on the market. This is a specific term for
the EU and European Economic Area (EEA) markets.
Medicare A US health insurance programme for US
citizens aged 65 or older, US citizens under age 65
with certain disabilities and US citizens of all ages
with permanent kidney failure requiring dialysis or a
kidney transplant. Recently, Medicare began offering
prescription drug coverage under Part D of the
Medicare Prescription Drug Benefit Program.
moving annual total (MAT) A figure that represents
the financial value of a variable for 12 months.
new chemical entity (NCE)/new molecular entity
(NME) A new, pharmacologically-active substance.
The term is used to differentiate from line extensions
and existing drug products. NCE is a term referring
to chemical substances whereas NME covers
all modalities.
new drug application (NDA) An application to the
US Food and Drug Administration for approval to
market a new medicine in the US.
NYSE New York Stock Exchange.
operating costs Distribution costs, research
and development costs and selling, general and
administrative costs.
operating profit Sales, less cost of sales, less
operating costs, plus operating income.
Ordinary Shares Ordinary Shares of $0.25 each
in the capital of the Company.
outcomes study A clinical trial (usually large)
assessing the effect of a drug in preventing or
delaying a specific and important medical event
(for example the occurrence of a heart attack).
parenteral Administered by injection (for example
intravenous, sub-cutaneous and intramuscular).
Pharmaceutical Research and Manufacturers of
America (PhRMA) The principal US pharmaceutical
industry association.
pharmacovigilance The scientific collection and
evaluation of information from healthcare providers
and patients relating to the adverse effects
of medicines.
Phase I The phase of clinical research where a new
drug or treatment is tested in small groups of people
(20 to 80) to check that the drug can achieve
appropriate concentrations in the body, determine
a safe dosage range and identify side effects.
This phase includes healthy volunteer studies.
Phase II This phase of clinical research includes the
controlled clinical activities conducted to evaluate the
effectiveness of the drug in patients with the disease
under study and to determine the common
short-term side effects and risks associated with the
drug. Phase II studies are typically conducted in a
relatively small number of patients (usually no more
than several hundred).
Phase III This phase of clinical research is performed
to gather additional information about effectiveness
and safety of the drug, often in a comparative setting,
to evaluate the overall benefit/risk profile of the drug.
Phase III studies usually include between several
hundred and several thousand patients.
placebo In clinical trials, an inert substance identical
in appearance to the substance being tested, also
known as a sugar pill.
poly-ADP-ribose polymerase (PARP) An enzyme
critical to the repair of damaged cells and
maintenance of cellular energy.
pre-clinical studies Studies conducted before a drug
is tested in human subjects, and which support and
help establish boundaries for safe use of the drug in
subsequent Phase I studies.
pressurised metered dose inhaler (pMDI) An
aerosol inhaler/puffer device for delivering medicine
directly into the lungs.
primary care The medical care that a patient receives
upon first contact with the healthcare system, before
referral elsewhere within the system.
profit before tax Operating profit, plus finance
income, less finance expense.
ROW Rest of World.
second-line treatment Treatment administered after
the failure of, or in addition to, first-line therapy.
Securities and Exchange Commission (SEC) US
governmental agency that regulates the securities
industry/stock market.
Senior Executive Team (SET) Team of heads of the
various AstraZeneca functions.
SG&A costs Selling, general and administrative costs.
siRNA molecules Small or short or silencing interfering
RNA. A class of 20-25 nucleotide double stranded
RNA molecules that interfere with the expression of
a specific gene. In this specific case, siRNA is a type
of anti-viral agent.
small molecule A general term used to describe
pharmaceutical R&D using chemistry and chemical
methods and materials to discover and develop new
medicines. Chemical molecules are small compared
with biological molecules.
specialist care The medical care the patient receives
after being referred by the primary care provider.
sterling, £, GBP, pence or p References to the
currency of the UK.
supplemental new drug application (sNDA)
An application made to the US Food and Drug
Administration to seek approval to market an additional
indication for a drug already on the market.
TSR Total shareholder return.
UK The United Kingdom of Great Britain and
Northern Ireland.
UK Combined Code Guidance that sets out
standards of good practice in corporate governance
for the UK.
US The United States of America.
US dollar, US$, USD or $ References to the currency
of the US.
World Health Organization (WHO) The United
Nations’ specialised agency for health.
XR Extended release.
Cautionary statement regarding forward-looking
statements
The purpose of this Annual Report and Form 20-F
Information is to provide information to the members
of the Company. In order, among other things, to
utilise the ‘safe harbour’ provisions of the US Private
Securities Litigation Reform Act 1995 and the UK
Companies Act 2006, we are providing the following
cautionary statement: This Annual Report and Form
20-F Information contains certain forward-looking
statements with respect to the operations,
performance and financial condition of the Group.
Although we believe our expectations are based on
reasonable assumptions, any forward-looking
statements, by their nature, involve risks and
uncertainties and may be influenced by factors
that could cause actual outcomes and results to
IMPORTANT INFORMATION
FOR READERS OF THIS REPORT
be materially different from those predicted. The
forward-looking statements reflect knowledge and
information available at the date of the preparation
of this Annual Report and Form 20-F Information
and the Company undertakes no obligation to
update these forward-looking statements. We
identify the forward-looking statements by using the
words ‘anticipates’, ‘believes’, ‘expects’, ‘intends’
and similar expressions in such statements.
Important factors that could cause actual results to
differ materially from those contained in forward-
looking statements, certain of which are beyond our
control, include, among other things, those factors
identified in the Principal Risks and Uncertainties
section on pages 74 to 82 of this document.
Nothing in this Annual Report and Form 20-F
Information should be construed as a profit
forecast.
Inclusion of reported, constant exchange rate
and core financial measures
Throughout the Directors’ Report and in the Financial
Highlights section on page 2 and 3 the following
measures are referred to:
Reported performance. Reported performance >
takes into account all the factors (including those
which we cannot influence, principally currency
exchange rates) that have affected the results of our
business as reflected in our Group Financial
Statements prepared in accordance with
International Financial Reporting Standards as
adopted by the European Union and as issued by
the International Accounting Standards Board.
Core financial measures. This is a non-GAAP measure >
because unlike reported performance it cannot be
derived directly from the information in the Group’s
Financial Statements. This measure is adjusted to
exclude certain significant items, such as charges
INTRODUCTION 2
AstraZeneca and our year in brief 2
Financial highlights 2
Chairman’s statement 4
Chief Executive Officer’s review 5
DIRECTORS’ REPORT 8
Introduction 8
Business environment 9
Strategy, goals and
performance measurement 12
Measuring our performance 1 > 4
Reporting our performance >
Financial and Non-financial 15
Resources, skills and capabilities 16
Medicines 1 > 6
Research and development 1 > 7
Development pipeline >
at 29 January 2009 22
Sales and marketing 2 > 5
Intellectual property 2 > 6
Supply and manufacturing 2 > 7
People 2 > 8
Financial review 31
Measuring performance 3 > 1
Business background and >
major events affecting 2008 32
Results of operations >
summary analysis of year
to 31 December 2008 33
Financial position, including >
cash flow and liquidity – 2008 34
Restructuring and synergy costs > 36
Capitalisation and shareholder return > 37
Future prospects 3 > 7
Results of operations >
summary analysis of year to
31 December 2007 38
Financial position, including >
cash flow and liquidity – 2007 40
Financial risk management 4 > 1
Critical accounting policies >
and estimates 43
Other accounting information 4 > 7
DIRECTORS’ REPORT 8
FINANCIAL STATEMENTS 98
REMUNERATION REPORT 174
ADDITIONAL INFORMATION 190
TRADE MARkS
Trade marks of the AstraZeneca group of companies
appear throughout this document in italics. AstraZeneca,
the AstraZeneca logotype and the AstraZeneca
symbol are all trade marks of the AstraZeneca group
of companies. Trade marks of companies other than
AstraZeneca appear with a
®
or
sign and include:
Abraxane
®
, a registered trade mark of Abraxis
BioScience, LLC.; Advair Diskus
, a trade mark
of GlaxoSmithKline group of companies; Aspirin
,
a trade mark of Bayer AG; Avastin
, a trade mark of
Genentech, Inc.; BiTE
, a trade mark of Micromet AG;
Cubicin
, a trade mark of Cubist Pharmaceuticals, Inc.;
Captisol
, a trade mark of CyDex Pharmaceuticals Inc.;
CytoFab
, a trade mark of Protherics, Inc.; Enbrel
,
a trade mark of Amgen group of companies;
EvaluatePharma
®
, a trade mark of Evaluate PLC;
Herceptin
, a trade mark of Genentech, Inc.; Humira
,
a trade mark of Abbott Biotechnology Ltd; Lean Sigma
,
a trade mark of Smallpiece Enterprises Limited;
Lipitor
, a trade mark of Pfizer Ireland Pharmaceuticals;
Onglyza
, a trade mark of the Bristol-Myers Squibb
Company; Prinivil
, a trade mark of Merck & Co., Inc.;
Remicade
, a trade mark of Centocor, Inc.; Seretide
,
a trade mark of GlaxoSmithKline group of companies;
Taxotere
, a trade mark of Aventis Pharma SA; TriCor
,
a trade mark of Fournier Industrie et Santé; Trilipix
,
a trade mark of Abbott Laboratories; Zocor
, a trade
mark of Merck & Co., Inc.; and Zyprexa
, a trade mark
of Eli Lilly and Company.
USE OF TERMS
In this Annual Report and Form 20-F Information,
unless the context otherwise requires, ‘AstraZeneca’,
‘the Group’, ‘we’, ‘us’ and ‘our’ refer to AstraZeneca
PLC and its consolidated entities.
STATEMENTS OF DATES
Except as otherwise stated, references to days
and/or months in this Annual Report and Form 20-F
Information are references to days and/or months
in 2008.
Designed by Addison Corporate Marketing Limited.
REGISTERED OFFICE AND
CORPORATE HEADQUARTERS
AstraZeneca PLC
15 Stanhope Gate
London W1K 1LN
UK
Tel: +44 (0)20 7304 5000
Fax: +44 (0)20 7304 5151
INVESTOR RELATIONS
E-mail:
IR@astrazeneca.com
UK: as above
Sweden:
AstraZeneca AB
SE-151 85 Söderlje
Sweden
Tel: +46 (0)8 553 260 00
Fax: +46 (0)8 553 290 00
US:
Investor Relations
AstraZeneca Pharmaceuticals LP
1800 Concord Pike
PO Box 15437
Wilmington
DE 19850-5437
US
Tel: +1 (302) 886 3000
Fax: +1 (302) 886 2972
REGISTRAR AND TRANSFER OFFICE
Equiniti Limited
Aspect House
Spencer Road
Lancing
West Sussex
BN99 6DA
UK
Tel (freephone in the UK):
0800 389 1580
Tel (outside the UK):
+44 (0)121 415 7033
SWEDISH CENTRAL SECURITIES DEPOSITORY
Euroclear Sweden AB
PO Box 7822
SE-103 97 Stockholm
Sweden
Tel: +46 (0)8 402 9000
US DEPOSITARY
JPMorgan Chase & Co
PO Box 64504
St Paul
MN 55164-0504
US
Tel (toll free in the US):
800 990 1135
Tel (outside the US):
+1 (651) 453 2128
E-mail: jpmorgan.adr@wellsfargo.com
ASTRAZENECA.COM
This Annual Report and Form 20-F Information
is also available online at astrazeneca.com/
annualreport2008
CONTACT INFORMATION
ASTRAZENECA ANNUAL REPORT AND FORM 20-F INFORMATION 2008
ASTRAZENECA ANNUAL REPORT
AND FORM 20-F INFORMATION 2008