AstraZeneca Annual Report and Form 20-F Information 2011

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GlossaryThe following abbreviations and expressions have the following meanings when used in this Annual Report:Abbott – Abbott Pharmaceuticals PR Ltd. with respect to Certriadand Abbott Laboratories, Inc. with respect to Crestor.Accord – Accord Healthcare, Inc.Affordable Care Act – the Patient Protection and Affordable CareAct which was signed into law on 23 March 2010 as amended by theHealth Care and Education Reconciliation Act which was signed intolaw on 30 March 2010.ADR – an American Depositary Receipt evidencing title to an ADS.ADS – an American Depositary Share representing one underlyingOrdinary Share.AGM – an Annual General Meeting of the Company.ANDA – an abbreviated new drug application, which is a marketingapproval application for a generic drug submitted to the FDA.Annual Report – this Annual Report and Form 20-F Information 2011.API – active pharmaceutical ingredient.Articles – the Articles of Association of the Company.ASA – acetylsalicylic acid.Astellas – Astellas Pharma, Inc.Astra – Astra AB, being the company with whom the Companymerged in 1999.Astra Tech – Astra Tech AB.AstraZeneca – the Company and its subsidiaries.AZIP – AstraZeneca Investment Plan.BMS – Bristol-Myers Squibb Company.Board – the Board of Directors of the Company.Bureau Veritas – Bureau Veritas UK Limited.CEO – the Chief Executive Officer of the Company.CER – constant exchange rates.CFO – the Chief Financial Officer of the Company.CHMP – the Committee for Medicinal Products for Human Use,being a committee of the EMA.CIS – Commonwealth of Independent States.Code of Conduct – the Group’s Code of Conduct.Company or Parent Company – AstraZeneca PLC (formerly ZenecaGroup PLC (Zeneca)).Complete Response Letter (CRL) – a letter issued by the FDAcommunicating its decision to a drug company that its NDA orbiological licensing application is not approvable as submitted. Thesubmitting drug company is required to respond to the CompleteResponse Letter if it wishes to pursue an approval for its submission.Corporate Integrity Agreement – the agreement described in theUS Corporate Integrity Agreement reporting section on page 51.Daiichi Sankyo – Daiichi Sankyo Company, Limited.Dainippon Sumitomo – Dainippon Sumitomo Pharmaceuticals Co.,Limited.Director – a director of the Company.earnings per share (EPS) – profit for the year after tax and minorityinterests, divided by the weighted average number of Ordinary Sharesin issue during the year.ECG – electrocardiagram.EMA – the European Medicines Agency.EMEA – Europe, Middle East and Africa.EU – the European Union.FDA – the US Food and Drug Administration, which is part of the USDepartment of Health and Human Services Agency, which is theregulatory authority for all pharmaceuticals (including biologics andvaccines) and medical devices in the US.Forest – Forest Laboratories Holdings Limited.EFPIA – European Federation of Pharmaceutical Industries andAssociations.GAAP – Generally Accepted Accounting Principles.GDP – gross domestic product.GERD – gastro-oesophageal reflux disease.GIA – AstraZeneca’s group internal audit function.gross margin – the margin, as a percentage, by which sales exceedthe cost of sales, calculated by dividing the difference between thetwo by the sales figure.Group – AstraZeneca PLC and its subsidiaries.GSK – GlaxoSmithKline plc.Handa – Handa Pharmaceuticals, LLC.HealthCore – HealthCore Inc.IAS – the International Accounting Standards.IASB – the International Accounting Standards Board.IFRS – the International Financial Reporting Standards or anInternational Financial Reporting Standard, as the context requires.IP – intellectual property.IT – information technology.IS – information services.KPI – key performance indicator.krona or SEK – references to the currency of Sweden.Lean – means enhancing value for customers with fewer resources.MAA – a marketing authorisation application, which is an applicationfor authorisation to place medical products on the market. This is aspecific term used in the EU and European Economic Area markets.MAb – monoclonal antibody, a biologic that is specific, that is, it bindsto and attacks one particular antigen.MedImmune – MedImmune, LLC (formerly MedImmune, Inc.).Merck – Merck Sharp & Dohme Corp. (formerly Merck & Co., Inc.).moving annual total (MAT) – a figure that represents the financialvalue of a variable for 12 months.NDA – a new drug application to the FDA for approval to market anew medicine in the US.NCE – new chemical entity.NERD – non-erosive reflux disease.NGO – non-governmental organisation.n/m – not meaningful.Novartis – Novartis Pharma A.G.Novexel – Novexel S.A.210 GlossaryAstraZeneca Annual Report and Form 20-F Information 2011
NSAID – a non-steroidal anti-inflammatory drug.NYSE – the New York Stock Exchange.operating profit – sales, less cost of sales, less operating costs, plusoperating income.Ordinary Share – an ordinary share of $0.25 each in the sharecapital of the Company.Orphan Drug – a drug which has been approved for use in arelatively low-incidence indication (an orphan indication) and has beenrewarded with a period of market exclusivity; the period of exclusivityand the available orphan indications vary between markets.OTC – over-the-counter.Paediatric Exclusivity – in the US, a six-month period of exclusivityto market a drug which is awarded by the FDA in return for certainpaediatric clinical studies using that drug. This six-month period runsfrom the date of relevant patent expiry. Analogous provisions areavailable in certain other territories (eg European SPC paediatricextensions).Patent Term Extension (PTE) – an extension of up to five yearsin the term of a US patent relating to a drug which compensates fordelays in marketing resulting from the need to obtain FDA approval.The analogous right in the EU is a supplementary protectioncertificate (SPC).PDUFA – Prescription Drug User Fee Act.Pfizer – Pfizer, Inc.Phase I – the phase of clinical research where a new drug ortreatment is tested in small groups of people (20 to 80) to checkthat the drug can achieve appropriate concentrations in the body,determine a safe dosage range and identify side effects. This phaseincludes healthy volunteer studies.Phase II – the phase of clinical research which includes the controlledclinical activities conducted to evaluate the effectiveness of the drug inpatients with the disease under study and to determine the commonshort-term side effects and risks associated with the drug. Phase IIstudies are typically conducted in a relatively small number of patients(usually no more than several hundred).Phase III – the phase of clinical research which is performed togather additional information about effectiveness and safety of thedrug, often in a comparative setting, to evaluate the overall benefit/riskprofile of the drug. Phase III studies usually include between severalhundred and several thousand patients.PhRMA – Pharmaceutical Research and Manufacturers of America.pounds sterling, £, GBP, pence or p – references to the currency ofthe UK.Pozen – Pozen Inc.Proof of Concept – data demonstrating that a candidate drug resultsin a clinical change on an acceptable endpoint or surrogate in patientswith the disease.PSP – AstraZeneca Performance Share Plan.PUD – peptic ulcer disease.QT prolongation – a biomarker of ventricular tachyarrhythmiasmeasured by ECG.R&D – research and development.Redeemable Preference Share – a redeemable preference shareof £1 each in the share capital of the Company.Regulatory Data Protection – see the Intellectual Property sectionfrom page 34.Regulatory Exclusivity – any of the IP rights arising from generationof clinical data and includes Regulatory Data Protection (as explainedin the Intellectual Property section from page 34), Paediatric Exclusivityand Orphan Drug status.Responsible Business Plan – the plan described in theResponsible Business section from page 47, further details of whichcan be found at our website, astrazeneca.com/responsible/management-and-measurement/responsible-business-plan.Rigel – Rigel Pharmaceuticals, Inc.RSV – respiratory syncytial virus.Sarbanes-Oxley Act – the US Sarbanes-Oxley Act of 2002.SEC – the US Securities and Exchange Commission, thegovernmental agency that regulates the US securities industry/stockmarket.Seroquel – Seroquel IR and Seroquel XR unless otherwise stated.SET – the Senior Executive Team.SHE – Safety, Health and Environment.SFDA – State Food and Drug Administration of China.SG&A costs – selling, general and administrative costs.Six Sigma – a rigorous and disciplined methodology that uses dataand statistical analysis to measure and improve a company’soperational performance by identifying and eliminating defects.sNDA – a supplemental new drug application, which is an applicationmade to the FDA to seek approval to market an additional indicationfor a drug already on the market.SOP – AstraZeneca Share Option Plan.Targacept – Targacept, Inc.Teva – Teva Pharmaceuticals USA, Inc.TKI – Tyrosine Kinase Inhibitors.TSR – total shareholder return, being the total return on a share over aperiod of time, including dividends reinvested.UK – the United Kingdom of Great Britain and Northern Ireland.UK Bribery Act – means the UK Bribery Act 2010.UK Corporate Governance Code – the UK Corporate GovernanceCode published by the Financial Reporting Council in May 2010that sets out standards of good practice in corporate governancefor the UK.US – the United States of America.US dollar, US$, USD or $ – references to the currency of the US.WHO – the World Health Organization, the United Nations’ specialisedagency for health.Additional InformationAstraZeneca Annual Report and Form 20-F Information 2011Glossary 211
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healthAstraZeneca Annual Reportand
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Financial summary$33.6bnSales down
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China: We announcedour decision to
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OverviewOperational overview7979 pr
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Chairman’s StatementI would like
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Chief Executive Officer’s ReviewA
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The process of getting a drug to ma
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OverviewnovationInnovation drives p
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Our Strategy and PerformanceMore pe
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Using the full range of innovative
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Our strategyMissionto make the most
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Our strategic priorities to 2014Our
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Our performance in 2011Our performa
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Business shapePeopleResponsible bus
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Strategy and PerformanceaborationIm
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Delivering our strategyOur strategy
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Development projects20112010 129342
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Investing in capabilitiesA core com
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Patent expiries for our key markete
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our Established Markets footprint i
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Product qualityWe are committed to
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We have a global approach, supporte
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ComplianceWe ensure a culture of et
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tegrityBusiness ReviewWe are dedica
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Delivering our strategyResponsible
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India has the fastest growing numbe
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ProtestsAstraZeneca acknowledges th
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Also in 2011, the DIHR in collabora
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healthcollaborationRaising breast c
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Pipeline by Therapy Area at 31 Dece
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Therapy Area ReviewIn September, we
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Therapy Area ReviewGastrointestinal
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Therapy Area ReviewInfectionTherapy
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Therapy Area ReviewIn the pipelineI
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Therapy Area ReviewOur financial pe
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Therapy Area ReviewOncologyTherapy
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Therapy Area Reviewendpoints of pro
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Therapy Area ReviewOur financial pe
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healthinnovationReducing the number
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Geographical ReviewUSAstraZeneca is
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Geographical ReviewEmerging Markets
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Disciplined execution of our strate
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Financial ReviewMeasuring performan
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Financial ReviewResults of operatio
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Financial ReviewFinancial position
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Financial ReviewCapitalisation and
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Financial ReviewResults of operatio
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Financial ReviewSensitivity analysi
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Financial Reviewover the performanc
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healthcollaborationFighting the ris
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Board of Directors and Senior Execu
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Board of Directors and Senior Execu
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Corporate Governance ReportOperatio
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Corporate Governance ReportThe Boar
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Corporate Governance ReportDuring 2
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Corporate Governance ReportBusiness
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Corporate Governance ReportPolitica
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Directors’ Remuneration ReportDav
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Directors’ Remuneration ReportVar
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Directors’ Remuneration ReportAdd
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Directors’ Remuneration ReportSum
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Directors’ Remuneration ReportSum
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Directors’ Remuneration ReportIn
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Directors’ Remuneration ReportPer
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Directors’ Remuneration ReportGai
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RiskManagement reporting and assura
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RiskCommercialisation and business
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RiskCommercialisation and business
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RiskSupply chain and delivery risks
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RiskEconomic and financial risks co
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Financial StatementsPreparation of
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Financial StatementsConsolidated St
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Financial StatementsConsolidated St
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Financial StatementsGroup Accountin
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Financial StatementsProperty, plant
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Financial StatementsNotes to the Gr
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Financial Statements3 Finance incom
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Financial Statements4 Taxation cont
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Financial Statements6 Segment infor
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Financial Statements9 Intangible as
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Page 164 and 165: Financial Statements15 Financial in
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Page 168 and 169: Financial Statements18 Post-retirem
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Page 172 and 173: Financial Statements20 Share capita
Page 174 and 175: Financial Statements23 Financial ri
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Page 178 and 179: Financial Statements24 Employee cos
Page 184 and 185: Financial Statements25 Commitments
Page 192 and 193: Financial Statements26 LeasesTotal
Page 194 and 195: Financial StatementsIndependent Aud
Page 196 and 197: Financial StatementsCompany Account
Page 198 and 199: Financial Statements4 ReservesShare
Page 200 and 201: Financial StatementsGroup Financial
Page 202 and 203: Development PipelineNCEsPhase III/R
Page 204 and 205: Development PipelineNCEsPhases I an
Page 206 and 207: Shareholder Information> For shares
Page 208 and 209: Shareholder InformationDocuments on
Page 210 and 211: Corporate InformationHistory and de
Page 214 and 215: Index2011 performance summary 23Acc
Page 216: Contact informationRegistered offic
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AstraZeneca Annual Report and Form 20-F Information 2011

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