Contact Information
`
`AstraZeneca Annual Report
`and Form 20-F Information 2009
`
`Health in the real world
`
`AstraZeneca Annual Report and Form 20-F Information 2009
`
`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
`
`Our website
`This Annual Report is also available
`on our website, astrazeneca.com/
`annualreport2009
`
`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 Södertälje
`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
`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
`
`Page 1 of 212
`
`AstraZeneca Exhibit 2103
`Mylan v. AstraZeneca
`IPR2015-01340
`
`

`
`Important information for readers
`of this Annual Report and Form
`20-F Information
`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. The Company and its Directors,
`employees, agents and advisors do not accept or
`assume responsibility to any other person to whom this
`Annual Report and Form 20-F Information is shown or
`into whose hands it may come and any such
`responsibility or liability is expressly disclaimed. 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. Forward-looking statements are statements
`relating to the future which are based on information
`available at the time such statements are made,
`including information relating to risks and uncertainties.
`Although we believe that the forward-looking
`statements in this Annual Report and Form 20-F
`Information are based on reasonable assumptions, the
`matters discussed in the forward-looking statements
`may be influenced by factors that could cause actual
`outcomes and results to be materially different from
`those expressed or implied by these statements. 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 from page 80 of this document. Nothing in this
`Annual Report and Form 20-F Information should be
`construed as a profit forecast.
`
`Inclusion of reported performance, core financial
`measures and constant exchange rate growth rates
`In Our year in brief section on page 2 and throughout the
`Directors’ Report 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 IFRS as adopted by the EU and
`as issued by the IASB.
`
` Core financial measures. These are non-GAAP >
`measures because unlike Reported performance they
`cannot be derived directly from the information in the
`Group’s Financial Statements. These measures are
`adjusted to exclude certain significant items, such as
`charges and provisions related to our global
`restructuring and synergy programmes, amortisation
`and impairment of the significant intangibles relating
`to the acquisition of MedImmune in 2007, the
`amortisation and impairment of the significant
`intangibles relating to our current and future exit
`arrangements with Merck in the US, and other
`specified items. See the Reconciliation of Reported
`results to Core results table on page 40 for a
`reconciliation of Reported to Core performance.
`
` Constant exchange rate (CER) growth rates. These >
`are also non-GAAP measures. These measures
`remove the effects of currency movements (by
`retranslating the current year’s performance at the
`
`previous year’s exchange rates and adjusting for other
`exchange effects, including hedging). A reconciliation of
`Reported results adjusted for the impact of currency
`movements is provided in the Operating profit (2009
`and 2008) table on page 39.
`
`Throughout this Annual Report and Form 20-F
`Information, growth rates are expressed at CER unless
`otherwise stated.
`
`AstraZeneca’s determination of non-GAAP measures
`together with our presentation of them within our
`financial information may differ from similarly titled
`non-GAAP measures of other companies.
`
`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 2009 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 2009; such data is not adjusted for
`Medicaid and similar state rebates. 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 CER. 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
`the 49 countries contained in the IMS Health MIDAS
`Quantum database, which amounted to approximately
`95% (in value) of the countries audited by IMS Health.
`
`AstraZeneca websites
`Information on or accessible through our websites,
`including astrazeneca.com, astrazenecaclinicaltrials.com
`and medimmune.com, does not form part of and is not
`incorporated into this document.
`
`External/third party websites
`Information on or accessible through any third party
`or external website does not form part of and is not
`incorporated into this document.
`
`Definitions
`The glossary and the market definitions table from page
`206 are intended to provide a useful guide to terms and
`AstraZeneca’s definition of markets, as well as to
`acronyms and abbreviations, used in this Annual Report
`and Form 20-F Information. They are, however,
`provided solely for the convenience of the reader and
`should therefore not be relied upon as providing a
`definitive view of the subject matter to which they relate.
`
`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 and any reference to
`‘this Annual Report’ is a reference to this Annual Report
`and Form 20-F Information.
`
`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 2009.
`
`Figures
`Figures in parentheses in tables and in the Financial
`Statements are used to represent negative numbers.
`
`AstraZeneca Annual Report and Form 20-F Information 2009
`
`Trade marks
`Trade marks of the AstraZeneca group of
`companies appear throughout this Annual Report 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 ™
`sign and include: Abraxane™, a trade mark of Abraxis
`BioScience, LLC.; Advair Diskus™, a trade mark of the
`GlaxoSmithKline group of companies; Cimzia™, a trade
`mark of UCB Pharma, S.A.; Cubicin™, a trade mark of
`Cubist Pharmaceuticals, Inc.; CytoFab™, a trade mark of
`Protherics, Inc.; Ethyol™, a trade mark of Scherico Ltd in
`certain countries and AstraZeneca in others; Iscover™,
`a trade mark of Sanofi-Aventis SA; Lipitor™, a trade mark
`of Pfizer Ireland Pharmaceuticals; Onglyza™, a trade
`mark of Bristol-Myers Squibb Company; Plavix™, a trade
`mark of Sanofi-Aventis SA; Prinivil™, a trade mark of
`Merck; Spiriva™, a trade mark of Boehringer Ingelheim
`Pharma GmbH & Co. KG; Trilipix™, a trade mark of
`Fournier Industrie et Santé; and Vioxx™, a trade mark
`of Merck.
`
`Designed and produced by Addison, www.addison.co.uk
`
`Page 2 of 212
`
`

`
`Key financial highlights
`
`Sales up 7% to $32,804 million
`($31,601 million in 2008)
`
`32.8bn
`23%
`7.7bn
`
`Core operating profit up 23% to
`$13,621 million ($10,958 million in 2008)
`
`Strong cash flows reduced net debt
`by $7,709 million resulting in net
`funds of $535 million
`
`Introduction
`
`01
`
`Welcome to our
`Annual Report 2009
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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`
`
` Contents
`
`02
`
`Introduction
`
`02 Our year in brief
`04 Chairman’s Statement
`05 CEO’s Review
`06 AstraZeneca at a glance
`08 Path to a new medicine
`
`10 Directors’ Report
`
` Performance
`12 Business Environment
`14 Strategy and Performance
`18 Resources, Skills and Capabilities
`
` Reviews
`36 Financial Review
`50 Geographical Review
`55 Therapy Area Review
`75 Other Businesses
`76 Environmental Sustainability
`77
`In the Global Community
`
` Corporate Governance
`79 Risk
`87 Business Organisation and Corporate Governance
`101 Directors’ Remuneration Report
`
`120 Financial Statements
`
`194 Additional Information
`
`196 Development Pipeline
`199 Shareholder Information
`204 Corporate Information
`205 Cross-reference to Form 20-F
`206 Glossary
`208
`Index
`
`AstraZeneca Annual Report and Form 20-F Information 2009
`
`Page 3 of 212
`
`

`
`02
`
`Introduction | Our year in brief
`
`Our year in brief
`Summary financial
`and operational
`information for 2009
`
`Financial highlights
`
`Sales $m (+7%)
`
`Net cash flow from operating activities $m
`
`2009
`2008
`2007
`
`32,804
`31,601
`29,559
`
`2009
`2008
`2007
`
`11,739
`8,742
`7,510
`
`Core operating profit $m (+23%)
`
`Reported operating profit $m (+24%)
`
`2009
`2008
`
`13,621
`10,958
`
`2009
`2008
`2007
`
`11,543
`9,144
`8,094
`
`Core gross margin $m (+10%)
`
`Reported gross margin $m (+11%)
`
`2009
`2008
`
`27,217
`25,408
`
`2009
`2008
`2007
`
`Core earnings per
`Ordinary Share $ (+23%)
`
`Reported basic earnings
`per Ordinary Share $ (+22%)
`
`7%
`2007
`
`2009
`2008
`2007
`
`6.32
`5.10
`4.38
`
`2009
`2008
`2007
`
`27,029
`25,003
`23,140
`
`5.19
`4.20
`3.74
`
`Sales growth
`
`7% 3%
`
`2009
`
`2008
`
`AstraZeneca Annual Report and Form 20-F Information 2009
`
`Page 4 of 212
`
`

`
`Introduction | Our year in brief
`
`03
`
`Dividend for 2009
`
`First interim dividend
`
`Second interim dividend
`
`Total
`
`$
`
`0.59
`
`1.71
`
`2.30
`
`Pence
`
` 36.0
`
`105.4
`
`141.4
`
`SEK
`
`4.41
`
`12.43
`
`16.84
`
`Payment date
`
` 14 September 2009
`
`15 March 2010
`
`$2.30
`
`Dividend per Ordinary Share 2009
`
`Sales
`Crestor sales were up 29% to
`
` >
`$4,502 million; Symbicort up 23% to
`$2,294 million; Seroquel up 12% to
`$4,866 million; and Arimidex up 7% to
`$1,921 million. Nexium sales fell by 1%
`to $4,959 million and Synagis sales fell
`by 12% to $1,082 million
`
`Sales of Toprol-XL and H1N1 influenza
`(swine flu) vaccine in the US accounted
`for 3 percentage points of the global
`revenue growth
`Emerging Markets growth was 12%,
`accounting for 13% of total revenue
`
` >
`
` >
`
` >
`
`Pipeline developments include
`Four major regulatory submissions made
` >
`Complete Response Letter submitted
` >
`for fifth regulatory submission
`In-licensing/acquisition of four
`late-stage projects
`89 projects in clinical development
`
`
`
`> R
`
`estructuring programme delivered
`annualised savings of $1.6 billion in 2009
`and expanded to deliver further savings
`
`Positioned in the top 6% in the sector
`in the Dow Jones World and STOXX
`(European) Indexes
`
`Up to $1 billion in Ordinary Shares will be
`re-purchased by the Company during 2010
`
`Note: All growth rates are at CER.
`
`2009
`2,977
`–
`
`2008
`2,739
`610
`
`2007
`2,641
`4,170
`
`23%
`
`Symbicort up 23% to $2,294 million
`
`4I
`
`n-licensing/acquisition of four
`late-stage projects
`
`Operational overview
`
`Distributions to shareholders $m
`
`Dividends
`Share re-purchases
`
`29%
`
`Crestor up 29% to $4,502 million
`
`4F
`
`our major regulatory submissions
`
`$1.6bn
`
`Annualised savings of $1.6 billion
`from restructuring
`
`6%
`
`Top 6% in the sector in the
`Dow Jones Indexes
`
`AstraZeneca Annual Report and Form 20-F Information 2009
`
`Page 5 of 212
`
`

`
`04
`
`Introduction | Chairman’s Statement
`
`We confirmed our commitment to being
`an integrated, global and innovation-driven
`prescription-based biopharmaceutical
`business. While there has already been much
`change in the business, the review also
`highlighted the need to redouble our efforts
`if we are to stay at the forefront of the sector.
`Our plans for the business are outlined in more
`detail in David’s Review and the Strategy
`and Performance section.
`
`In recognition of the Group’s strong balance
`sheet, sustainable significant cash flow
`and the Board’s confidence in the strategic
`direction and long-term prospects for the
`business, we have adopted a progressive
`dividend policy, intending to maintain or
`grow the dividend each year. In order
`to ensure that long-term management
`incentives and shareholder interests remain
`aligned, we are tabling proposals for a new
`share-based long-term incentive plan for
`shareholder approval. This has been
`developed as part of an overall review of
`executive remuneration. Further information
`about this plan and the review can be found
`in the Directors’ Remuneration Report from
`page 101 and in the Notice of AGM.
`
`During 2009, Håkan Mogren retired from
`the Board, having been a Director of the
`Company since its formation in 1999.
`Before then, he had served as Chief
`Executive Officer and a Director of Astra AB
`for more than 10 years. He brought a wealth
`of experience and sound judgement to the
`work of the Board which we valued highly.
`As announced last year, John Patterson
`also retired in 2009. On behalf of their
`fellow Directors, I would like to reiterate
`my thanks to both of them for their service
`to the Company.
`
`Once again, the Board would like to place
`on record its appreciation of the leadership
`shown by David Brennan and his team.
`On behalf of the Board I would also like to
`thank AstraZeneca employees around the
`world for their contribution to what has been
`a very successful year. Their contribution,
`which has been the foundation of our past
`success, is also needed more than ever as
`we address the challenges to come. I am
`confident that AstraZeneca has the skills
`and capabilities to continue that success
`by harnessing both its own efforts and the
`efforts of those with whom we work.
`
`Louis Schweitzer
`Chairman
`
`Chairman’s Statement
`
`Despite the difficult world economic
`conditions, 2009 was a successful
`year for AstraZeneca. Our strong
`performance and considerable
`achievement in making a real
`difference to patient health around
`the world meant that our shareholders
`were also able to benefit.
`
`Group sales increased by 7% in 2009 to a
`total of $32,804 million. Reported operating
`profit was $11,543 million, up 24%. Reported
`earnings per share for the full year were
`$5.19 (2008: $4.20). The Board has
`recommended a second interim dividend
`of $1.71, a 14% increase over the second
`interim dividend awarded in 2008. This
`brings the dividend for the full year to
`$2.30 (141.4 pence, SEK 16.84), an
`increase of 12% from 2008. In 2009,
`cash distributions to shareholders
`through dividends totalled $2,977 million.
`
`Meeting patient need lies at the heart of
`what we do. In 2009, immediate need was
`met when our people and technology
`enabled us to develop and be the first to
`market an H1N1 influenza (swine flu) vaccine
`in the US. Equally, when generic producers
`proved unable to supply the market for
`Toprol-XL, we successfully rebuilt our supply
`chain to fill the void.
`
`2009 was also a year in which AstraZeneca
`science was at the forefront of the industry,
`ensuring that we are able to meet patient
`need in the longer term. Two of the biggest
`landmark clinical trials to report in recent
`years, the Crestor JUPITER and the Brilinta
`PLATO trials, engaged academic and clinical
`communities across the globe. We have
`
`made regulatory submissions based on the
`results of these trials.
`
`Our strategic focus is on innovation-driven
`medicines that are valued by patients and
`payers alike. We continue to invest in new
`medicines and we work to protect our
`investments by rigorously defending our
`patent rights and thereby optimising our
`intellectual property. To this end, AstraZeneca
`will vigorously defend the challenge to the
`Crestor US substance patent brought by a
`number of generic drug manufacturers when
`the case goes to trial in February 2010.
`
`Worldwide, pharmaceutical industry revenue
`growth, while positive, is slowing. This is due
`to pressure on healthcare costs, exacerbated
`by the current economic downturn, as well
`as increased competition from generic
`medicines. We believe pressures on costs
`are likely to continue, especially in the US.
`
`Nevertheless, the demand for healthcare
`that will drive the industry’s future growth
`remains strong, especially from economic
`and demographic growth in Emerging
`Markets and the growing number of
`patients there who can afford our
`medicines. In response to these
`developments we have continued to drive
`change in the business. We are reshaping
`our presence in Established Markets to
`ensure we remain competitive and investing
`in Emerging Markets around the world so
`that we can benefit from their growth.
`
`We used our assessment of the future
`for the pharmaceutical sector as the basis
`for the annual strategy review with
`David Brennan and his executive team.
`
`AstraZeneca Annual Report and Form 20-F Information 2009
`
`Page 6 of 212
`
`

`
`Introduction | CEO’s Review
`
`05
`
`business processes and support services,
`such as HR. To meet evolving customer needs
`we are adapting our methods of sales and
`marketing and altering our supply chains.
`
`Our drive to improve efficiency and
`effectiveness across AstraZeneca has resulted
`in further reductions in our workforce. The
`executive team and I remain committed to
`ensuring that we manage these changes in
`the right way. This means that, in meeting the
`needs of the business, we deal responsibly
`and sympathetically with affected individuals
`and the communities in which they live.
`
`We continue to integrate responsible business
`considerations into everyday decision-making
`across all our activities, reinforcing personal
`accountability for compliance with our Code
`of Conduct through training and monitoring
`of business practices. We were pleased to
`have our efforts recognised externally with
`improved scores in the 2009 Dow Jones
`Index. Looking ahead, we have identified
`areas for improvement and will take action
`to strengthen further our governance and
`management processes, building on our
`progress to date and driving continuous
`improvement throughout the business.
`
`2009 also saw some changes to the
`executive team. Jan Lundberg, Executive
`Vice-President, Discovery Research left
`AstraZeneca in November. We thank him for
`his significant contribution to the business.
`Christer Köhler has taken over the role on
`an interim basis. Bruno Angelici, Executive
`Vice-President, International Sales and
`Marketing Organisation, will be leaving
`AstraZeneca later in 2010. He has made an
`enormous contribution and we thank him for
`his sound judgement and strong leadership.
`
`Finally, the achievements of the year
`would not have been possible without the
`dedication and hard work of all our employees,
`to whom I offer my thanks. For many of our
`employees 2009 was a year of change. The
`pace of change is not going to let up in 2010.
`Indeed, it is going to accelerate. I am
`confident that our staff will respond with the
`commitment they have shown in the past.
`
`we made during the year to withdraw the
`regulatory submissions we had made for
`our anti-cancer medicine, Zactima, came as
`a disappointment.
`
`As projects leave the development pipeline,
`we replenish it with new projects that will
`yield regulatory submissions in future years.
`We now have 11 projects in Phase III
`development. Twenty-nine projects entered
`the pipeline during the year and 53 projects
`were progressed to their next phase of
`development. We seek to provide each
`of these projects with a business case
`underpinned by a clear scientific rationale
`and sound financial case.
`
`In strengthening our pipeline we look beyond
`our own laboratories to access the best
`science and external sources of innovation.
`As a result, a significant number of our projects
`come from our programme of collaboration.
`These include two of our regulatory filings:
`Certriad was submitted with Abbott and
`Vimovo was submitted by our partner Pozen
`Inc. In addition, Onglyza™ was the first product
`of our diabetes collaboration with BMS.
`
`CEO’s Review
`
`2009 was a year of considerable
`achievement in which I believe we
`laid firm foundations for the future
`success of the business. Underpinning
`all this is excellent execution of our
`plans, improved organisational
`flexibility and a committed workforce.
`
`Operational highlights of the year include four
`significant regulatory filings for new medicines
`and two product launches. We agreed four
`late-stage project collaborations and have
`89 projects in clinical development. In addition,
`sales of Toprol-XL and H1N1 influenza
`(swine flu) vaccine in the US accounted for
`three percentage points of the global revenue
`growth at CER, while growth in Emerging
`Markets was up 12%, accounting for 13% of
`total revenue. 2009 was also the year in which
`we reached an agreement in principle with the
`US Attorney’s Office to settle claims relating
`to Seroquel sales and marketing practices
`and to make a payment of $524 million
`(including interest).
`
`If we are to bring benefits to patients and
`create value for shareholders, we need
`a constant flow of new and innovative
`medicines. Of the four regulatory filings
`made in 2009, Brilinta is a treatment for
`acute coronary syndromes, Certriad is for the
`treatment of lipid abnormalities and Vimovo
`is for arthritic pain. The fourth submission
`was for a fixed-dose combination of Onglyza™
`and metformin for treating diabetes. 2009
`saw Onglyza™ launched in the US and in
`the EU for the treatment of Type 2 diabetes.
`Iressa, our anti-cancer medicine, was
`launched in the EU. Of course, in the process
`of developing new medicines, we experience
`setbacks as well as successes. The decision
`
`Other collaborations agreed in 2009 included
`the in-licence from Forest of ceftaroline, a ‘next
`generation’ anti-infective. We enhanced the
`value of this programme in December with
`an agreement to acquire Novexel, a private
`infection research company. We also agreed
`in-licensing deals with Nektar and Targacept.
`
`The Strategy and Performance section
`from page 14 outlines our plans and priorities
`for 2010 and beyond, which we need to
`implement to ensure we prosper in the years
`ahead. In doing so, we will improve the health
`of patients around the world and thereby
`create value for our shareholders.
`
`A further focus in 2009 was the continued
`reshaping of the business to give us the
`organisational flexibility we need to take
`advantage of opportunities. Initiatives include
`outsourcing some of our R&D activities, other
`
`David R Brennan
`Chief Executive Officer
`
`AstraZeneca Annual Report and Form 20-F Information 2009
`
`Page 7 of 212
`
`

`
`06
`
`Introduction | AstraZeneca at a glance
`
`AstraZeneca
`at a glance
`
`Who we are
`
`What we do
`
`AstraZeneca is a global, innovation-driven
`biopharmaceutical business
`
`Our mission is to make the most meaningful difference
`to the health of patients through great medicines
`
`We do this with a range of medicines designed to
`improve patients’ health and quality of life around
`the world
`
`We are focused on the discovery, development and
`commercialisation of prescription medicines for six
`important areas of healthcare
`
`We have a broad product range that includes many leaders
`in the treatment of the world’s most serious illnesses
`
`We have 10 medicines with sales of more than $1 billion
`each in 2009
`
`We are committed to developing each activity within
`our business in a responsible way
`
`We use our scientific and commercial skills to develop a
`pipeline of innovative new products to meet medical need
`
`Key product
`Crestor (for managing cholesterol levels)
`Nexium (for acid reflux)
`Synagis (for RSV, a form of respiratory infection
`in infants)
`Seroquel (for schizophrenia, bipolar disorder
`and major depressive disorder)
`Arimidex (for breast cancer)
`Symbicort (for asthma and chronic obstructive
`pulmonary disease)
`
`
`
`Healthcare area
`Cardiovascular
`Gastrointestinal
`Infection
`
`Neuroscience
`
`Our work is supported by our values and the conduct
`of employees in working with each other and
`our stakeholders
`
`We believe that our approach delivers lasting value
`for patients, society and our shareholders
`
`Oncology
`Respiratory & Inflammation
`
` 62,700
`
`62,700 employees worldwide
`
` $1bn
`
`10 medicines with sales of over $1 billion each in 2009
`
`AstraZeneca Annual Report and Form 20-F Information 2009
`
`Page 8 of 212
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`

`
`Introduction | AstraZeneca at a glance
`
`07
`
`How we work
`
`Where we work
`
`We are committed to working in a spirit of collaboration
`to achieve our goal of better health for patients
`
`We recognise the value of collaborative work, and so
`continually seek to develop new ways of working with
`others who complement our existing skills, enhance our
`internal innovation or bring extra value to what we do
`
`We have a global reach but local knowledge, being
`active in over 100 countries, with a growing presence in
`emerging markets such as China, Brazil, India and Russia
`
`In 2009 we had sales of $15,981 million in North America,
`$12,471 million in Other Established Markets and
`$4,352 million in Emerging Markets
`
`Our products rely not only on teamwork within
`AstraZeneca but on working with doctors, patients
`and other stakeholders to understand what they need
`and want
`
`We also work with governments and those who pay
`for healthcare to ensure our products represent value
`for money
`
`We work with NGOs and others to improve local
`healthcare in vulnerable communities around the world
`
`
`
`Combining our disease area expertise with country-
`specific knowledge helps us to market and sell
`medicines that best meet local needs
`
`Of our 62,700 employees worldwide, 47% are in
`Europe, 31% in the Americas and 22% in Asia, Africa
`and Australasia
`
`Around 11,600 people work in our R&D organisation
`and we have 17 principal R&D centres in eight countries,
`including Sweden, the US and the UK
`
`We have 9,500 employees at 20 manufacturing sites
`in 16 countries
`
` 60
`
`60 major R&D collaborations in the last three years
`
`
`
` 100+
`
`Active in over 100 countries
`
`AstraZeneca Annual Report and Form 20-F Information 2009
`
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`
`08
`
`Introduction | Path to a new medicine
`
`Path to a new medicine
`
`The discovery, development and commercialisation of a medicine is a complex
`process. This is a high level overview of the process for a new small molecule
`medicine. It is illustrative only. It is not intended to (and nor does it) represent
`the life-cycle of any particular medicine or of every medicine discovered and/
`or developed by AstraZeneca.
`
` AstraZeneca people
` AstraZeneca stakeholders and other third parties
`
`External clinicians
`and organisations may be
`involved in the design and
`running of these studies.
`These third parties are
`typically involved at
`each study phase
`
`Begin the process
`of seeking patent
`protection for the
`potential medicine
`
`Collaborations with
`academia and external
`clinicians to access the
`best external science and
`medical opinion. These
`third parties may be
`involved throughout the
`medicine’s life-cycle
`
`1
`Find potential medicine
`Having identified the unmet
`medical need and the market
`opportunity, find a potential
`medicine, through laboratory
`research, that is potent,
`selective and absorbed into
`and safe in the body
`
`Begin to develop
`manufacturing route
`to ensure the
`manufacturing process
`is robust and costs
`are minimised
`
`3
`Phase I studies
`Studies typically in small
`groups of healthy human
`volunteers (may include
`patients in later part of Phase I)
`to understand how the potential
`medicine is absorbed in the
`body, distributed around it and
`excreted. Also to determine
`a safe dosage and identify
`side effects
`
`Create appropriate
`branding for the new
`medicine in
`preparation for
`its launch
`
`5
`Phase III studies
`Studies in a larger group
`of patients to gather
`information about
`effectiveness and safety
`of the medicine and
`evaluate the overall
`benefit/risk profile
`
`Years
`1
`0
`During the discovery phase
`
`2
`
`3
`
`4
`6
`5
`During the development phase
`
`7
`
`8
`
`9
`
`2
`Safety and initial
`efficacy studies
`Studies in the lab and
`in animals to determine
`if the potential medicine
`is safe to introduce
`into humans and in
`what quantities
`
`Understand likely
`efficacy, side
`effect profile and
`maximum dose
`estimate in
`humans
`
`To ensure
`patient safety,
`regulatory authorities
`approve the testing
`of the medicine
`in humans
`
`AstraZeneca Annual Report and Form 20-F Information 2009
`
`4
`Phase II studies
`Studies in small groups
`of patients to evaluate
`effectiveness of
`the medicine
`
`During Phase II studies,
`design a Phase III programme
`to deliver data required for
`regulatory approval and
`pricing and/or reimbursement
`throughout the world
`
`External advisory panels
`help define the attributes
`to test in studies to
`demonstrate whether the
`potential new medicine can
`be differentiated from the
`existing standard
`treatment of care
`
`Regulatory authorities
`ensure the safety and
`efficacy of the medicine
`and grant approval for its
`marketing. Large numbers
`of national, regional and
`local payers grant
`approval for the pricing
`and/or reimbursement
`of the medicine
`
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`

`
`At any stage of the
`development process
`the medicine may have
`been acquired from a
`collaborating company.
`The collaborator may
`remain involved in the
`future development and
`commercialisation
`of the medicine
`
`Create appropriate
`branding for the new
`medicine in
`preparation for
`its launch
`
`Studies in a larger group
`
`effectiveness and safety
`
`Introduction | Path to a new medicine
`
`09
`
`Clinicians begin
`to prescribe medicine
`and patients begin
`to benefit
`
`Regulatory authorities
`approve any
`extensions to the
`patient populations to
`whom the medicine
`may be prescribed
`
`Market and sell
`medicine. Continuously
`monitor, record and
`analyse reported side
`effects. Review need to
`update the side effect
`warnings to ensure that
`patients’ safety
`is maintained
`
`Work with external
`advisory groups
`and regulatory authorities to
`consider potential additional
`diseases which might be
`treated by the medicine or
`better ways
`of administering
`the medicine
`
`7
`Launch new
` medicine
`Raise awareness of
`patient benefit and
`appropriate use
`
`9
`Life-cycle
`management
`Broaden understanding
`of the full potential
`of the medicine
`
`9
`
`10
`
`13
`12
`11
`Post launch: delivering to patients
`
`14
`
`15
`
`16
`
`17
`
`18
`
`20+
`
`6
`Regulatory submission
`Seek approval from
`regulatory authorities
`to market and sell
`the medicine
`
`Submit package of
`clinical data which
`demonstrates the
`safety and efficacy
`of the medicine to
`the regulatory
`authorities
`
`8
`Post-laun