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1、UNITED STATES SECURITIES AND EXCHANGE COMMISSIONWashington,D.C.20549FORM 10-K(Mark One)ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934For the fiscal year ended December 31,2022 TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934
2、For the transition period from to Commission file number 1-3619 PFIZER INC.(Exact name of registrant as specified in its charter)Delaware13-5315170(State or other jurisdiction of incorporation or organization)(I.R.S.Employer Identification Number)66 Hudson Boulevard East,New York,New York 10001-2192
3、(Address of principal executive offices)(zip code)(212)733-2323(Registrants telephone number,including area code)Securities registered pursuant to Section 12(b)of the Act:Title of each classTrading Symbol(s)Name of each exchange on which registeredCommon Stock,$.05 par valuePFENew York Stock Exchang
4、e1.000%Notes due 2027PFE27New York Stock ExchangeSecurities registered pursuant to Section 12(g)of the Act:NoneIndicate by check mark if the registrant is a well-known seasoned issuer,as defined in Rule 405 of the Securities Act.Yes No Indicate by check mark if the registrant is not required to file
5、 reports pursuant to Section 13 or Section 15(d)of the Act.Yes No Indicate by check mark whether the registrant(1)has filed all reports required to be filed by Section 13 or 15(d)of the Securities Exchange Act of 1934 during the preceding 12 months(or for such shorter period that the registrant was
6、required to file such reports),and(2)has been subject to such filing requirements for the past 90 days.Yes No Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T(232.405 of this chapter
7、)during the preceding 12 months(or for such shorter period that the registrant was required to submit such files.)Yes No Indicate by check mark whether the registrant is a large accelerated filer,an accelerated filer,a non-accelerated filer,a smaller reporting company or an emerging growth company.S
8、ee the definitions of“large accelerated filer,”“accelerated filer”,“smaller reporting company”and“emerging growth company”in Rule 12b-2 of the Exchange Act.Large Accelerated filer Accelerated filer Non-accelerated filer Smaller reporting company Emerging growth company If an emerging growth company,
9、indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a)of the Exchange Act.Indicate by check mark whether the registrant has filed a report on and attestatio
10、n to its managements assessment of the effectiveness of its internal control over financial reporting under Section 404(b)of the Sarbanes-Oxley Act(15 U.S.C.7262(b)by the registered public accounting firm that prepared or issued its audit report.If securities are registered pursuant to Section 12(b)
11、of the Act,indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of
12、 incentive-based compensation received by any of the registrants executive officers during the relevant recovery period pursuant to 240.10D-1(b).Indicate by check mark whether the registrant is a shell company(as defined in Rule 12b-2 of the Exchange Act).Yes No The aggregate market value of the vot
13、ing stock held by non-affiliates of the registrant,computed by reference to the closing price as of the last business day of the registrants most recently completed second fiscal quarter,July 3,2022,was approximately$294 billion.This excludes shares of common stock held by directors and executive of
14、ficers at July 3,2022.Exclusion of shares held by any person should not be construed to indicate that such person possesses the power,directly or indirectly,to direct or cause the direction of the management or policies of the registrant,or that such person is controlled by or under common control w
15、ith the registrant.The registrant has no non-voting common stock.The number of shares outstanding of the registrants common stock as of February 21,2023 was 5,619,074,621 shares of common stock,all of one class.DOCUMENTS INCORPORATED BY REFERENCEPortions of the Proxy Statement for the 2023 Annual Me
16、eting of ShareholdersPart IIITABLE OF CONTENTS PageDefined TermsiAvailable InformationiiiForward-Looking Information and Factors that May Affect Future Results1PART I3ITEM 1.BUSINESS3About Pfizer3Commercial Operations3Research and Development4Collaboration and Co-Promotion Agreements5International O
17、perations5Sales and Marketing6Patents and Other Intellectual Property Rights6Competition8Pricing Pressures and Managed Care Organizations9Raw Materials9Government Regulation and Price Constraints10Environmental Matters12Human Capital12ITEM 1A.RISK FACTORS14ITEM 1B.UNRESOLVED STAFF COMMENTSN/AITEM 2.
18、PROPERTIES23ITEM 3.LEGAL PROCEEDINGS23ITEM 4.MINE SAFETY DISCLOSURESN/AINFORMATION ABOUT OUR EXECUTIVE OFFICERS23PART II24ITEM 5.MARKET FOR THE COMPANYS COMMON EQUITY,RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES24ITEM 6.RESERVED25ITEM 7.MANAGEMENTS DISCUSSION AND ANALYSIS OF
19、 FINANCIAL CONDITION AND RESULTS OF OPERATIONS25ITEM 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK44ITEM 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA45ITEM 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE101ITEM 9A.CONTROLS AND PROCEDURES101ITEM
20、 9B.OTHER INFORMATIONN/AITEM 9C.DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONSN/APART III104ITEM 10.DIRECTORS,EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE104ITEM 11.EXECUTIVE COMPENSATION104ITEM 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHO
21、LDER MATTERS104ITEM 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS,AND DIRECTOR INDEPENDENCE104ITEM 14.PRINCIPAL ACCOUNTING FEES AND SERVICES104PART IV104ITEM 15.EXHIBITS,FINANCIAL STATEMENT SCHEDULES10415(a)(1)Financial Statements10415(a)(2)Financial Statement Schedules10415(a)(3)Exhibits104ITEM
22、 16.FORM 10-K SUMMARY108SIGNATURES109N/A=Not ApplicableDEFINED TERMSUnless the context requires otherwise,references to“Pfizer,”“the Company,”“we,”“us”or“our”in this Form 10-K(defined below)refer to Pfizer Inc.and its subsidiaries.Pfizers fiscal year-end for subsidiaries operating outside the U.S.is
23、 as of and for the year ended November 30 for each year presented.Pfizers fiscal year-end for U.S.subsidiaries is as of and for the year ended December 31 for each year presented.References to“Notes”in this Form 10-K are to the Notes to the consolidated financial statements in Item 8.Financial State
24、ments and Supplementary Data in this Form 10-K.We also have used several other terms in this Form 10-K,most of which are explained or defined below:Form 10-KThis Annual Report on Form 10-K for the fiscal year ended December 31,20222021 Form 10-KOur Annual Report on Form 10-K for the fiscal year ende
25、d December 31,2021Proxy StatementProxy Statement for the 2023 Annual Meeting of Shareholders,which will be filed no later than 120 days after December 31,2022AbbVieAbbVie Inc.ABOAccumulated benefit obligation;represents the present value of the benefit obligation earned through the end of the year b
26、ut does not factor in future compensation increasesACIPAdvisory Committee on Immunization PracticesALKanaplastic lymphoma kinaseAlliance revenuesRevenues from alliance agreements under which we co-promote products discovered or developed by other companies or usArenaArena Pharmaceuticals,Inc.ArrayAr
27、ray BioPharma Inc.ArvinasArvinas,Inc.AstellasAstellas Pharma Inc.,Astellas US LLC and Astellas Pharma US,Inc.ATTR-CMtransthyretin amyloid cardiomyopathyBeamBeam Therapeutics Inc.BiohavenBiohaven Pharmaceutical Holding Company Ltd.BioNTechBioNTech SEBiopharmaGlobal Biopharmaceuticals BusinessBLABiolo
28、gics License ApplicationBMSBristol-Myers Squibb CompanyBODBoard of DirectorsCDCU.S.Centers for Disease Control and PreventioncGMPcurrent Good Manufacturing PracticesCGRPcalcitonin gene-related peptideCMAconditional marketing authorisationCMSCenters for Medicare&Medicaid ServicesComirnaty*Unless othe
29、rwise noted,refers to,as applicable,and as authorized or approved,the Pfizer-BioNTech COVID-19 Vaccine,the Pfizer-BioNTech COVID-19 Vaccine,Bivalent(Original and Omicron BA.4/BA.5),the Comirnaty Original/Omicron BA.1 Vaccine,and Comirnaty Original/Omicron BA.4/BA.5 VaccineCond.J-NDAConditional Japan
30、 New Drug ApplicationConsumer Healthcare JVGSK Consumer Healthcare JVCOVID-19novel coronavirus disease of 2019CStoneCStone PharmaceuticalsDEAU.S.Drug Enforcement AgencyDeveloped EuropeIncludes the following markets:Western Europe,Scandinavian countries and FinlandDeveloped MarketsIncludes the follow
31、ing markets:U.S.,Developed Europe,Japan,Canada,South Korea,Australia and New ZealandDeveloped Rest of WorldIncludes the following markets:Japan,Canada,South Korea,Australia and New ZealandECEuropean CommissionEMAEuropean Medicines AgencyEmerging MarketsIncludes,but is not limited to,the following ma
32、rkets:Asia(excluding Japan and South Korea),Latin America,Central Europe,Eastern Europe,the Middle East,Africa and TurkeyEPSearnings per shareESGEnvironmental,Social and GovernanceESOPemployee stock ownership planEUEuropean UnionEUAemergency use authorizationExchange ActSecurities Exchange Act of 19
33、34,as amendedFASBFinancial Accounting Standards BoardFCPAU.S.Foreign Corrupt Practices ActFDAU.S.Food and Drug AdministrationFFDCAU.S.Federal Food,Drug and Cosmetic ActGAAPGenerally Accepted Accounting PrinciplesGBTGlobal Blood Therapeutics,Inc.GDFVgrant-date fair valuePfizer Inc.2022 Form 10-KiGPDG
34、lobal Product Development organizationGSKGlaxoSmithKline plcHaleonHaleon plcHHSU.S.Department of Health and Human ServicesHIPAAHealth Insurance Portability and Accountability Act of 1996HospiraHospira,Inc.IPR&Din-process research and developmentIRAInflation Reduction Act of 2022IRCInternal Revenue C
35、odeIRSU.S.Internal Revenue ServiceITinformation technologyJAKJanus kinaseJVjoint ventureKingKing Pharmaceuticals LLC(formerly King Pharmaceuticals,Inc.)LIBORLondon Interbank Offered RateLillyEli Lilly and CompanyLOEloss of exclusivityMCOmanaged care organizationmCRCmetastatic colorectal cancermCRPCm
36、etastatic castration-resistant prostate cancermCSPCmetastatic castration-sensitive prostate cancerMD&AManagements Discussion and Analysis of Financial Condition and Results of OperationsMDLMulti-District LitigationMedivationMedivation LLC(formerly Medivation,Inc.)MeridianMeridian Medical Technologie
37、s,Inc.MoodysMoodys Investors ServicemRNAmessenger ribonucleic acidMSAManufacturing Supply AgreementMTMmark-to-marketMTM change in accounting principleIn the first quarter of 2021,we adopted a change in accounting principle to a more preferable policy under U.S.GAAP to immediately recognize actuarial
38、 gains and losses arising from the remeasurement of our pension and postretirement plans(MTM Accounting).MylanMylan N.V.Mylan-Japan collaborationa pre-existing strategic collaboration between Pfizer and Mylan for generic drugs in Japan that terminated on December 21,2020MyovantMyovant Sciences Ltd.N
39、AVnet asset valueNDAnew drug applicationnmCRPCnon-metastatic castration-resistant prostate cancerNSCLCnon-small cell lung cancerNYSENew York Stock ExchangeOnoOno Pharmaceutical Co.,Ltd.OPKOOPKO Health,Inc.OTCover-the-counterPaxlovid*an oral COVID-19 treatment(nirmatrelvir PF-07321332 tablets and rit
40、onavir tablets)PBMpharmacy benefit managerPBOProjected benefit obligation;represents the present value of the benefit obligation earned through the end of the year and factors in future compensation increasesPC1Pfizer CentreOnePGSPfizer Global SupplyPharmaciaPharmacia CorporationPRACPharmacovigilanc
41、e Risk Assessment CommitteePrevnar familyIncludes Prevnar 13/Prevenar 13(pediatric and adult)and Prevnar 20(adult)PsApsoriatic arthritisQCEquality consistency evaluationRArheumatoid arthritisRCCrenal cell carcinomaR&Dresearch and developmentReViralReViral Ltd.ROUright of useS&PStandard&PoorsSECU.S.S
42、ecurities and Exchange CommissionSI&Aselling,informational and administrativePfizer Inc.2022 Form 10-KiisNDAsupplemental new drug applicationTax Cuts and Jobs Act or TCJALegislation commonly referred to as the U.S.Tax Cuts and Jobs Act of 2017TrilliumTrillium Therapeutics Inc.TSAstransition service
43、arrangementsUCulcerative colitisU.K.United KingdomUpjohn BusinessPfizers former global,primarily off-patent branded and generics business,which included a portfolio of 20 globally recognized solid oral dose brands,including Lipitor,Lyrica,Norvasc,Celebrex and Viagra,as well as a U.S.-based generics
44、platform,Greenstone,that was spun-off on November 16,2020 and combined with Mylan to create ViatrisU.S.United StatesValnevaValneva SEVBPvolume-based procurementViatrisViatris Inc.ViiVViiV Healthcare LimitedVyndaqel familyIncludes Vyndaqel,Vyndamax and VynmacWRDMWorldwide Research,Development and Med
45、icalWTOWorld Trade Organization*Paxlovid and emergency uses of the Pfizer-BioNTech COVID-19 Vaccine or the Pfizer-BioNTech COVID-19 Vaccine,Bivalent(Original and Omicron BA.4/BA.5),have not been approved or licensed by the FDA.Paxlovid has been authorized for emergency use by the FDA under an EUA,fo
46、r the treatment of adults and pediatric patients(12 years of age and older weighing at least 40 kg)with a current diagnosis of mild-to-moderate COVID-19 and who are at high risk for progression to severe COVID-19,including hospitalization or death.Emergency uses of the Pfizer-BioNTech COVID-19 Vacci
47、ne and the Pfizer-BioNTech COVID-19 Vaccine,Bivalent have been authorized by the FDA under an EUA to prevent COVID-19 in individuals aged 6 months and older.The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency u
48、se of the medical product during the COVID-19 pandemic under Section 564(b)(1)of the FFDCA,unless the declaration is terminated or authorization revoked sooner.Please see the EUA Fact Sheets at and www.cvdvaccine-.This Form 10-K includes discussion of certain clinical studies relating to various in-
49、line products and/or product candidates.These studies typically are part of a larger body of clinical data relating to such products or product candidates,and the discussion herein should be considered in the context of the larger body of data.In addition,clinical trial data are subject to differing
50、 interpretations,and,even when we view data as sufficient to support the safety and/or effectiveness of a product candidate or a new indication for an in-line product,regulatory authorities may not share our views and may require additional data or may deny approval altogether.Some amounts in this F
51、orm 10-K may not add due to rounding.All percentages have been calculated using unrounded amounts.All trademarks mentioned are the property of their owners.AVAILABLE INFORMATIONOur website is .This Form 10-K,our Quarterly Reports on Form 10-Q,our Current Reports on Form 8-K and our proxy statements,
52、and amendments to those reports filed or furnished pursuant to Section 13(a)or 15(d)of the Exchange Act,are,or will be,available(free of charge)on our website,in text format and,where applicable,in interactive data file format,as soon as reasonably practicable after we electronically file this mater
53、ial with,or furnish it to,the SEC.Throughout this Form 10-K,we“incorporate by reference”certain information from other documents filed or to be filed with the SEC,including our Proxy Statement.Please refer to this information.This Form 10-K will be available on our website on or about February 23,20
54、23.Our Proxy Statement will be available on our website on or about March 16,2023.Our 2022 ESG Report,which provides enhanced ESG disclosures,will be available on our website on or about March 16,2023.We also have a Pfizer Investor Insights website,which includes articles on the company,its products
55、 and its pipeline,located at .Information in our ESG Report and on the Pfizer Investor Insights website are not incorporated by reference into this Form 10-K.We may use our website as a means of disclosing material information and for complying with our disclosure obligations under Regulation Fair D
56、isclosure promulgated by the SEC.These disclosures are included on our website in the“AboutInvestors”or“Newsroom”sections.Accordingly,investors should monitor these portions of our website,in addition to following our press releases,SEC filings,public conference calls and webcasts,as well as our soc
57、ial media channels(our Facebook,Instagram(Pfizerinc),YouTube and LinkedIn pages and Twitter accounts(Pfizer and Pfizer_News).The information contained on our website,our Facebook,Instagram,YouTube and LinkedIn pages or our Twitter accounts,or any third-party website,is not incorporated by reference
58、into this Form 10-K.Information relating to corporate governance at Pfizer,including our Corporate Governance Principles;Director Qualification Standards;Pfizer Policies on Business Conduct(for all of our employees,including our Chief Executive Officer,Chief Financial Officer and Principal Accountin
59、g Officer);Code of Business Conduct and Ethics for Members of the Board of Directors;information concerning our Directors;ways to communicate by e-mail with our Directors;information concerning our Board Committees;Committee Charters;Charter of the Lead Independent Director;and transactions in Pfize
60、r securities by Directors and Officers are available on our website.We will provide any of the foregoing information without charge upon written request to our Corporate Secretary,Pfizer Inc.,66 Hudson Boulevard East,New York,NY 10001-2192.We will disclose any future amendments to,or waivers from,pr
61、ovisions of the Pfizer Policies on Business Conduct affecting our Chief Executive Officer,Chief Financial Officer,Principal Accounting Officer and executive officers on our website as promptly as practicable,as may be required under applicable SEC and NYSE rules.Information relating to shareholder s
62、ervices,including the Computershare Investment Program,book-entry share ownership and direct deposit of dividends,is also available on our website.Pfizer Inc.2022 Form 10-KiiiFORWARD-LOOKING INFORMATION AND FACTORS THAT MAY AFFECT FUTURE RESULTSThis Form 10-K contains forward-looking statements.We a
63、lso provide forward-looking statements in other materials we release to the public,as well as public oral statements.Given their forward-looking nature,these statements involve substantial risks,uncertainties and potentially inaccurate assumptions.We have tried,wherever possible,to identify such sta
64、tements by using words such as“will,”“may,”“could,”“likely,”“ongoing,”“anticipate,”“estimate,”“expect,”“project,”“intend,”“plan,”“believe,”“assume,”“target,”“forecast,”“guidance,”“goal,”“objective,”“aim,”“seek,”“potential,”“hope”and other words and terms of similar meaning or by using future dates.W
65、e include forward-looking information in our discussion of the following,among other topics:our anticipated operating and financial performance,reorganizations,business plans,strategy and prospects;expectations for our product pipeline,in-line products and product candidates,including anticipated re
66、gulatory submissions,data read-outs,study starts,approvals,launches,clinical trial results and other developing data;revenue contribution and projections;potential pricing and reimbursement;potential market dynamics and size;growth,performance,timing of exclusivity and potential benefits;strategic r
67、eviews,capital allocation objectives,dividends and share repurchases;plans for and prospects of our acquisitions,dispositions and other business development activities,and our ability to successfully capitalize on growth opportunities and prospects;sales,expenses,interest rates,foreign exchange rate
68、s and the outcome of contingencies,such as legal proceedings;expectations for impact of or changes to existing or new government regulations or laws;our ability to anticipate and respond to macroeconomic,geopolitical,health and industry trends,pandemics,acts of war and other large-scale crises;and m
69、anufacturing and product supply.In particular,forward-looking information in this Form 10-K includes statements relating to specific future actions,performance and effects,including,among others,the expected benefits of the organizational changes to our operations;our 2023 revenue expectations;our o
70、ngoing efforts to respond to COVID-19,including our plans and expectations regarding Comirnaty and Paxlovid,and any potential future vaccines or treatments;the forecasted revenue,demand,manufacturing and supply of Comirnaty and Paxlovid,including expectations for the commercial market for Comirnaty
71、and Paxlovid;our expectations regarding the impact of COVID-19 on our business;the expected patent term for Comirnaty;the expectations for ongoing revenue streams from Comirnaty and Paxlovid;the expected impact of patent expiries and generic competition;the expected pricing pressures on our products
72、 and the anticipated impact to our business;the availability of raw materials for 2023;the benefits expected from our business development transactions;our anticipated liquidity position;the anticipated costs and savings from certain of our initiatives,including our Transforming to a More Focused Co
73、mpany program;our planned capital spending;and the expected benefit payments from and employer contributions to our benefit plans.Given their nature,we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part.Actual outcomes may vary materiall
74、y from past results and those anticipated,estimated,implied or projected.These forward-looking statements may be affected by underlying assumptions that may prove inaccurate or incomplete,or by known or unknown risks and uncertainties,including those described in this section and in the Item 1A.Risk
75、 Factors section in this Form 10-K.Therefore,you are cautioned not to unduly rely on forward-looking statements,which speak only as of the date of this Form 10-K.We undertake no obligation to update forward-looking statements,whether as a result of new information,future events or otherwise,except a
76、s required by applicable securities law.You are advised,however,to consult any further disclosures we make on related subjects.Some of the factors that could cause actual results to differ are identified below,as well as those discussed in the Item 1A.Risk Factors section in this Form 10-K and withi
77、n MD&A.We note these factors for investors as permitted by the Private Securities Litigation Reform Act of 1995.The occurrence of any of the risks identified below,in the Item 1A.Risk Factors section in this Form 10-K,or within MD&A,or other risks currently unknown,could have a material adverse effe
78、ct on our business,financial condition or results of operations,or we may be required to increase our accruals for contingencies.It is not possible to predict or identify all such factors.Consequently,you should not consider the following to be a complete discussion of all potential risks or uncerta
79、inties:Risks Related to Our Business,Industry and Operations,and Business Development:the outcome of R&D activities,including,the ability to meet anticipated pre-clinical or clinical endpoints,commencement and/or completion dates for our pre-clinical or clinical trials,regulatory submission dates,an
80、d/or regulatory approval and/or launch dates;the possibility of unfavorable pre-clinical and clinical trial results,including the possibility of unfavorable new pre-clinical or clinical data and further analyses of existing pre-clinical or clinical data;risks associated with preliminary,early stage
81、or interim data;the risk that pre-clinical and clinical trial data are subject to differing interpretations and assessments,including during the peer review/publication process,in the scientific community generally,and by regulatory authorities;and whether and when additional data from our pipeline
82、programs will be published in scientific journal publications,and if so,when and with what modifications and interpretations;our ability to successfully address comments received from regulatory authorities such as the FDA or the EMA,or obtain approval for new products and indications from regulator
83、s on a timely basis or at all;regulatory decisions impacting labeling,including the scope of indicated patient populations,product dosage,manufacturing processes,safety and/or other matters,including decisions relating to emerging developments regarding potential product impurities;the impact of,or
84、uncertainties regarding the ability to obtain,recommendations by technical or advisory committees;and the timing of pricing approvals and product launches;claims and concerns that may arise regarding the safety or efficacy of in-line products and product candidates,including claims and concerns that
85、 may arise from the outcome of post-approval clinical trials,which could impact marketing approval,product labeling,and/or availability or commercial potential,including uncertainties regarding the commercial or other impact of the results of the Xeljanz ORAL Surveillance(A3921133)study or actions b
86、y regulatory authorities based on analysis of ORAL Surveillance or other data,including on other JAK inhibitors in our portfolio;the success and impact of external business development activities,including the ability to identify and execute on potential business development opportunities;the abilit
87、y to satisfy the conditions to closing of announced transactions in the anticipated time frame or at all;the ability to realize the anticipated benefits of any such transactions in the anticipated time frame or at all;the Pfizer Inc.2022 Form 10-K1potential need for and impact of additional equity o
88、r debt financing to pursue these opportunities,which could result in increased leverage and/or a downgrade of our credit ratings;challenges integrating the businesses and operations;disruption to business and operations relationships;risks related to growing revenues for certain acquired products;si
89、gnificant transaction costs;and unknown liabilities;competition,including from new product entrants,in-line branded products,generic products,private label products,biosimilars and product candidates that treat or prevent diseases and conditions similar to those treated or intended to be prevented b
90、y our in-line products and product candidates;the ability to successfully market both new and existing products,including biosimilars;difficulties or delays in manufacturing,sales or marketing;supply disruptions,shortages or stock-outs at our facilities or third-party facilities that we rely on;and
91、legal or regulatory actions;the impact of public health outbreaks,epidemics or pandemics(such as the COVID-19 pandemic)on our business,operations and financial condition and results,including impacts on our employees,manufacturing,supply chain,sales and marketing,R&D and clinical trials;risks and un
92、certainties related to our efforts to continue to develop and commercialize Comirnaty and Paxlovid or any potential future COVID-19 vaccines or treatments,as well as challenges related to their manufacturing,supply and distribution;risks related to our ability to achieve our revenue forecasts for Co
93、mirnaty and Paxlovid or any potential future COVID-19 vaccines or treatments,including,among other things,whether and when additional supply or purchase agreements will be reached and the risk that demand for any products may be reduced,no longer exist or not meet expectations,which may lead to exce
94、ss inventory on-hand and/or in the channel or reduced revenues;trends toward managed care and healthcare cost containment,and our ability to obtain or maintain timely or adequate pricing or favorable formulary placement for our products;interest rate and foreign currency exchange rate fluctuations,i
95、ncluding the impact of possible currency devaluations and monetary policy actions in countries experiencing high inflation rates;any significant issues involving our largest wholesale distributors or government customers,which account for a substantial portion of our revenues;the impact of the incre
96、ased presence of counterfeit medicines or vaccines in the pharmaceutical supply chain;any significant issues related to the outsourcing of certain operational and staff functions to third parties;and any significant issues related to our JVs and other third-party business arrangements;uncertainties
97、related to general economic,political,business,industry,regulatory and market conditions including,without limitation,uncertainties related to the impact on us,our customers,suppliers and lenders and counterparties to our foreign-exchange and interest-rate agreements of challenging global economic c
98、onditions,such as inflation,and recent and possible future changes in global financial markets;any changes in business,political and economic conditions due to actual or threatened terrorist activity,geopolitical instability,civil unrest or military action;the impact of product recalls,withdrawals a
99、nd other unusual items,including uncertainties related to regulator-directed risk evaluations and assessments,including our ongoing evaluation of our product portfolio for the potential presence or formation of nitrosamines;trade buying patterns;the risk of an impairment charge related to our intang
100、ible assets,goodwill or equity-method investments;the impact of,and risks and uncertainties related to,restructurings and internal reorganizations,as well as any other corporate strategic initiatives and growth strategies,and cost-reduction and productivity initiatives,each of which requires upfront
101、 costs but may fail to yield anticipated benefits and may result in unexpected costs or organizational disruption;the ability to successfully achieve our climate goals and progress our environmental sustainability priorities;Risks Related to Government Regulation and Legal Proceedings:the impact of
102、any U.S.healthcare reform or legislation or any significant spending reductions or cost controls affecting Medicare,Medicaid or other publicly funded or subsidized health programs,including the IRA,or changes in the tax treatment of employer-sponsored health insurance that may be implemented;U.S.fed
103、eral or state legislation or regulatory action and/or policy efforts affecting,among other things,pharmaceutical product pricing,intellectual property,reimbursement or access or restrictions on U.S.direct-to-consumer advertising;limitations on interactions with healthcare professionals and other ind
104、ustry stakeholders;as well as pricing pressures for our products as a result of highly competitive insurance markets;legislation or regulatory action in markets outside of the U.S.,including China,affecting pharmaceutical product pricing,intellectual property,reimbursement or access,including,in par
105、ticular,continued government-mandated reductions in prices and access restrictions for certain biopharmaceutical products to control costs in those markets;the exposure of our operations globally to possible capital and exchange controls,economic conditions,expropriation and other restrictive govern
106、ment actions,changes in intellectual property legal protections and remedies,the impact of political or civil unrest or military action,including the ongoing conflict between Russia and Ukraine and its economic consequences,unstable governments and legal systems,inter-governmental disputes and natur
107、al disasters or disruptions related to climate change;legal defense costs,insurance expenses,settlement costs and contingencies,including those related to actual or alleged environmental contamination;the risk and impact of an adverse decision or settlement and the risk related to adequacy of reserv
108、es related to legal proceedings;the risk and impact of tax related litigation and investigations;governmental laws and regulations affecting our operations,including,without limitation,the recently enacted IRA,changes in laws and regulations or their interpretation,including,among others,changes in
109、tax laws and regulations internationally and in the U.S.,Pfizer Inc.2022 Form 10-K2the adoption of global minimum taxation requirements outside the U.S.and potential changes to existing tax law by the current U.S.Presidential administration and Congress.Risks Related to Intellectual Property,Technol
110、ogy and Security:any significant breakdown or interruption of our IT systems and infrastructure(including cloud services);any business disruption,theft of confidential or proprietary information,security threats on facilities or infrastructure,extortion or integrity compromise resulting from a cyber
111、-attack or other malfeasance by,but not limited to,nation states,employees,business partners or others;the risk that our currently pending or future patent applications may not be granted on a timely basis or at all,or any patent-term extensions that we seek may not be granted on a timely basis,if a
112、t all;and risks to our products,patents and other intellectual property,such as:(i)claims of invalidity that could result in LOE;(ii)claims of patent infringement,including asserted and/or unasserted intellectual property claims;(iii)challenges faced by our collaboration or licensing partners to the
113、 validity of their patent rights;or(iv)any pressure,or legal or regulatory action by,various stakeholders or governments that could potentially result in us not seeking intellectual property protection or agreeing not to enforce or being restricted from enforcing intellectual property rights related
114、 to our products,including Comirnaty and Paxlovid.PART IITEM 1.BUSINESSABOUT PFIZERPfizer Inc.is a research-based,global biopharmaceutical company.We apply science and our global resources to bring therapies to people that extend and significantly improve their lives through the discovery,developmen
115、t,manufacture,marketing,sale and distribution of biopharmaceutical products worldwide.We work across developed and emerging markets to advance wellness,prevention,treatments and cures that challenge the most feared diseases of our time.We collaborate with healthcare providers,governments and local c
116、ommunities to support and expand access to reliable,affordable healthcare around the world.The Company was incorporated under the laws of the State of Delaware on June 2,1942.Most of our revenues come from the manufacture and sale of biopharmaceutical products.We believe that our medicines and vacci
117、nes provide significant value for healthcare providers and patients,through improved treatment of diseases,improvements in health,wellness and productivity as well as by reducing other healthcare costs,such as emergency room or hospitalization.We seek to enhance the value of our medicines and vaccin
118、es and actively engage in dialogues about how we can best work with patients,physicians and payers to prevent and treat disease and improve outcomes.We seek to maximize patient access and evaluate our pricing arrangements and contracting methods with payers to minimize adverse impact on our revenues
119、 within the current legal and pricing structures.We are committed to fulfilling our purpose:Breakthroughs that change patients lives.Our purpose fuels everything we do and reflects both our passion for science and our commitment to patients.In addition,Pfizer continues to enhance its ESG strategy,wh
120、ich is focused on six areas where we see opportunities to create a meaningful impact:product innovation;equitable access and pricing;product quality and safety;diversity,equity and inclusion;climate change;and business ethics.We are committed to strategically capitalizing on growth opportunities,pri
121、marily by advancing our own product pipeline and maximizing the value of our existing products,but also through various business development activities.We view our business development activity as an enabler of our strategies and seek to generate growth by pursuing opportunities and transactions tha
122、t have the potential to strengthen our business and our capabilities.We assess our business,assets and scientific capabilities/portfolio as part of our regular,ongoing portfolio review process and also continue to consider business development activities that will help advance our business strategy.
123、Our significant recent business development activities in 2022 include,among others:(i)the March 2022 acquisition of Arena,a clinical stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases;(ii)the October 2022 acquisition of GBT,a biopharmac
124、eutical company dedicated to the discovery,development and delivery of life-changing treatments that provide hope to underserved patient communities,starting with sickle cell disease;and(iii)the October 2022 acquisition of Biohaven,the maker of Nurtec ODT/Vydura(rimegepant),an innovative therapy for
125、 both acute treatment of migraine and prevention of episodic migraine in adults.For a further discussion of our strategy and our business development initiatives,see the Overview of Our Performance,Operating Environment,Strategy and Outlook section within MD&A and Note 2.COMMERCIAL OPERATIONSIn the
126、fourth quarter of 2021,we began managing our commercial operations through a global structure consisting of two operating segments,each led by a single manager:Biopharma,our innovative science-based biopharmaceutical business,and PC1,our global contract development and manufacturing organization and
127、 a leading supplier of specialty active pharmaceutical ingredients.Beginning in the third quarter of 2022,we made several organizational changes to further transform our operations to better leverage our expertise in certain areas and in anticipation of potential future new product or indication lau
128、nches.Pfizer Inc.2022 Form 10-K3The changes include establishing a new commercial structure within Biopharma,optimizing our end-to-end R&D operations and further prioritizing our internal R&D portfolio,as well as realigning certain enabling and platform functions across the organization to ensure al
129、ignment with this new operating structure,which is designed to better support and optimize performance across three broad customer groups as follows:Customer GroupsDescriptionKey ProductsPrimary CareIncludes:Former Internal Medicine product portfolio(innovative brands in cardiovascular metabolic,mig
130、raine and womens health,as well as regional brands)Former Vaccines product portfolio(innovative vaccines across all ages with a pipeline focus on infectious diseases with significant unmet medical need)Products for COVID-19 prevention and treatment,and potential future mRNA and antiviral products El
131、iquis,Nurtec ODT/Vydura and the Premarin family The Prevnar family,Nimenrix,FSME/IMMUN-TicoVac and Trumenba Comirnaty PaxlovidSpecialty CareIncludes:Former Inflammation&Immunology product portfolio(innovative brands and biosimilars for chronic immune and inflammatory diseases)Former Rare Disease pro
132、duct portfolio(innovative brands for a number of therapeutic areas with rare diseases,including amyloidosis,hemophilia,endocrine diseases and sickle cell disease)Former Hospital portfolio(global portfolio of sterile injectable and anti-infective medicines,excluding Paxlovid)Xeljanz,Enbrel(outside th
133、e U.S.and Canada),Inflectra,Eucrisa/Staquis and Cibinqo The Vyndaqel family,Oxbryta,BeneFIX and Genotropin Sulperazon,Medrol,Zavicefta,Zithromax,Vfend and PanzygaOncologyIncludes innovative oncology brands of biologics,small molecules,immunotherapies and biosimilars across a wide range of cancers.Ib
134、rance,Xtandi,Inlyta,Retacrit,Lorbrena and BraftoviFor additional information on our operating segments and products,including product revenues,see Note 17,and for additional information on the key operational revenue drivers of our business,see the Analysis of the Consolidated Statements of Income s
135、ection within MD&A.For a discussion of the risks associated with our dependence on certain of our major products,see the Item 1A.Risk FactorsConcentration section in this Form 10-K.RESEARCH AND DEVELOPMENTR&D is at the heart of fulfilling our purpose to deliver breakthroughs that change patients liv
136、es as we work to translate advanced science and technologies into the therapies that may be the most impactful for patients.In addition to discovering and developing new products,our R&D efforts seek to add value to our existing products by improving their effectiveness and ease of dosing and by dis
137、covering potential new indications.Our R&D Priorities and Strategy.Our R&D priorities include:delivering a pipeline of highly differentiated medicines and vaccines where we have a unique opportunity to bring the most important new therapies to patients in need;advancing our capabilities that can pos
138、ition us for long-term R&D leadership;and advancing new models for partnerships with creativity,flexibility and urgency to deliver innovation to patients as quickly as possible.To that end,our R&D primarily focuses on our main therapeutic areas,which are inflammation and immunology,internal medicine
139、,oncology,rare diseases,vaccines,and anti-infectives.While a significant portion of our R&D is internal,we also seek promising chemical and biological lead molecules and innovative technologies developed by others to incorporate into our discovery and development processes or projects,as well as our
140、 portfolio.We do so by entering into collaboration,alliance and license agreements with universities,biotechnology companies and other firms as well as through acquisitions and investments.These collaboration,alliance and license agreements and investments allow us to share knowledge,risk and cost.T
141、hey also enable us to access external scientific and technological expertise,as well as provide us the opportunity to advance our own products and in-licensed or acquired products.For information on certain of these collaborations,alliances and license arrangements and investments,see Note 2.Our R&D
142、 Operations.In 2022,we continued to strengthen our global R&D operations and pursue strategies to improve R&D productivity to achieve a sustainable pipeline that is positioned to deliver value in the near term and over time.Our R&D activity is conducted through various platform functions that operat
143、e in parallel within our global operations,including the following:WRDM.Research units within WRDM are generally responsible for research and early-stage development assets for our business(assets that have not yet achieved proof-of-concept)and are organized by therapeutic area to enhance flexibilit
144、y,cohesiveness and focus.We can rapidly redeploy resources within a research unit and between various projects to leverage,as necessary,common skills,expertise or focus.Science-based platform-services organizations within WRDM provide technical expertise and other services to various R&D projects an
145、d are organized into science-based functions.These organizations allow us to react more quickly and effectively to evolving needs by sharing resources among projects,candidates and targets across therapeutic areas and phases of development.GPD.Our GPD organization is a unified center for clinical de
146、velopment and regulatory activities that is generally responsible for the clinical development strategy and operational execution of clinical trials for both early-and late-stage clinical assets in Pfizers pipeline.We manage R&D operations on a total-company basis through our platform functions desc
147、ribed above.Specifically,the Portfolio Management Team(PMT),composed of senior executives,is accountable for aligning resources among all of our WRDM,GPD and R&D projects and for seeking to ensure optimal capital allocation across the innovative R&D portfolio.We believe that this approach also serve
148、s to maximize accountability and flexibility.Pfizer Inc.2022 Form 10-K4We do not disaggregate total R&D expense by development phase or by therapeutic area since,as described above,we do not manage all of our R&D operations by development phase or by therapeutic area.Further,as we are able to adjust
149、 a significant portion of our spending quickly,we believe that any prior-period information about R&D expense by development phase or by therapeutic area would not necessarily be representative of future spending.For additional information,see the Costs and ExpensesResearch and Development Expenses
150、section within MD&A and Note 17.Our R&D Pipeline.The process of drug and biological product discovery from initiation through development and to potential regulatory approval is lengthy and can take more than ten years.As of January 31,2023,we had the following number of projects in various stages o
151、f R&D:Development of a single compound is often pursued as part of multiple programs.While our drug candidates may or may not receive regulatory approval,new candidates entering clinical development phases are the foundation for future products.Information concerning several of our drug candidates i
152、n development,as well as supplemental filings for existing products,is set forth in the Product Developments section within MD&A.The discovery and development of drugs,vaccines and biological products are time consuming,costly and unpredictable.For information on the risks associated with R&D,see th
153、e Item 1A.Risk FactorsResearch and Development section in this Form 10-K.COLLABORATION AND CO-PROMOTION We use collaboration and/or co-promotion arrangements to enhance our development,R&D,sales and distribution of certain biopharmaceutical products,which include,among others,the following:Comirnaty
154、 is an mRNA-based coronavirus vaccine to help prevent COVID-19,which is being jointly developed and commercialized with BioNTech.Pfizer and BioNTech equally share the costs of development for the Comirnaty program.Comirnaty has been granted an approval or an authorization in many countries around th
155、e world in populations varying by country.We also share gross profits equally from commercialization of Comirnaty and are working jointly with BioNTech in our respective territories to commercialize the vaccine worldwide(excluding China,Hong Kong,Macau and Taiwan),subject to regulatory authorization
156、s or approvals market by market.For discussion on Comirnaty,see the Overview of Our Performance,Operating Environment,Strategy and OutlookCOVID-19 section within MD&A.Eliquis(apixaban)is part of the Novel Oral Anticoagulant market and was jointly developed and commercialized with BMS as an alternati
157、ve treatment option to warfarin in appropriate patients.We fund between 50%and 60%of all development costs depending on the study,and profits and losses are shared equally except in certain countries where we commercialize Eliquis and pay a percentage of net sales to BMS.In certain smaller markets w
158、e have full commercialization rights and BMS supplies the product to us at cost plus a percentage of the net sales to end-customers.Xtandi(enzalutamide)is an androgen receptor inhibitor that blocks multiple steps in the androgen receptor signaling pathway within tumor cells that is being developed a
159、nd commercialized in collaboration with Astellas.We share equally in the gross profits and losses related to U.S.net sales and also share equally all Xtandi commercialization costs attributable to the U.S.market,subject to certain exceptions.In addition,we share certain development and other collabo
160、ration expenses.For international net sales we receive royalties based on a tiered percentage.Bavencio(avelumab)is a human anti-programmed death ligand-1(PD-L1)antibody that is being developed and commercialized in collaboration with Merck KGaA.We jointly fund the majority of development and commerc
161、ialization costs and split profits equally related to net sales generated from any products containing avelumab.Orgovyx(relugolix)is an oral gonadotropin-releasing hormone(GnRH)receptor antagonist for the treatment of adult patients with advanced prostate cancer that is being developed and commercia
162、lized with Myovant.The companies are also collaborating on Myfembree(relugolix 40 mg,estradiol 1.0 mg,and norethindrone acetate 0.5 mg)for heavy menstrual bleeding associated with uterine fibroids in premenopausal women and the management of moderate to severe pain associated with endometriosis in p
163、remenopausal women.The companies equally share profits and allowable expenses in the U.S.for Orgovyx,and in the U.S.and Canada for Myfembree,with Myovant bearing our share of allowable expenses up to a maximum of$50 million in 2022.Pfizer does not have rights outside of these markets.Myovant remains
164、 responsible for regulatory interactions and drug supply and continues to lead clinical development for the relugolix combination tablet.Revenues associated with these arrangements are included in Alliance revenues(except in certain markets where we have direct sales and except for the majority of r
165、evenues for Comirnaty,which are included as direct product revenues).In addition,we have collaboration arrangements for the development and commercialization of certain pipeline products that are in development stage,including,among others,(i)with BioNTech to develop a modified mRNA-based vaccine fo
166、r the prevention of varicella zoster(Shingles),and(ii)with Valneva to co-develop and commercialize Valnevas Lyme disease vaccine candidate,VLA15.For further discussion of collaboration and co-promotion agreements,see the Item 1A.Risk FactorsCollaborations and Other Relationships with Third Parties s
167、ection in this Form 10-K and Notes 2 and 17.INTERNATIONAL OPERATIONSOur operations are conducted globally,and we supply our medicines and vaccines to over 185 countries and territories.Emerging markets are an important component of our strategy for global leadership,and our commercial structure reco
168、gnizes that the demographics and rising economic power of the fastest-growing emerging markets are becoming more closely aligned with the profile found within developed markets.Urbanization and the rise of the middle class in emerging markets provide potential growth opportunities for our products.P
169、fizer Inc.2022 Form 10-K5Revenues from operations outside the U.S.of$57.9 billion accounted for 58%of our total revenues in 2022.Revenues exceeded$500 million in each of 24,21 and 8 countries outside the U.S.in 2022,2021 and 2020,respectively.The increase in the number of countries exceeding$500 mil
170、lion in revenues in 2022 and 2021 was primarily driven by Comirnaty as well as,in 2022,Paxlovid.As a percentage of revenues,our largest country outside the U.S.was Japan in 2022.For a geographic breakdown of revenues,see the Revenues by Geography section within MD&A and Note 17B.Revenues by Country
171、as%of Total Revenues42%37%52%8%9%6%50%54%42%U.S.JapanOther202220212020Our international operations are subject to risks inherent in carrying on business in other countries.For additional information,see the Item 1A.Risk FactorsGlobal Operations and Item 1.BusinessGovernment Regulation and Price Cons
172、traints sections in this Form 10-K.SALES AND MARKETINGOur prescription biopharmaceutical products,with the exception of Paxlovid,are sold principally to wholesalers,but we also sell directly to retailers,hospitals,clinics,government agencies and pharmacies.In 2022,we principally sold Paxlovid to gov
173、ernment agencies.In the U.S.,we primarily sell our vaccines directly to the federal government,CDC,wholesalers,individual provider offices,retail pharmacies and integrated delivery systems.Outside the U.S.,we primarily sell our vaccines to government and non-government institutions.Certain of these
174、government contracts may be renegotiated or terminated at the discretion of a government entity.In addition,our contracts with government and supranational organizations for the sales of Comirnaty and Paxlovid,which are binding contracts,represented a significant amount of revenues in 2022.To date,w
175、e primarily sold Comirnaty and Paxlovid globally under government contracts.We expect sales of Comirnaty and Paxlovid in the U.S.will transition to commercial channels in the second half of 2023.We also seek to gain access for our products on formularies,which are lists of approved medicines availab
176、le to members of healthcare programs or PBMs.PBMs use various benefit designs,such as tiered co-pays for formulary products,to drive utilization of products in preferred formulary positions.We may also work with payers on disease management programs that help to develop tools and materials to educat
177、e patients and physicians on key disease areas.For information on our significant customers,see Note 17C.We promote our products to healthcare providers and patients consistent with applicable laws.Through our marketing organizations,we explain the approved uses,benefits and risks of our products to
178、 healthcare providers and patients;MCOs that provide insurance coverage,such as hospitals,integrated delivery systems,PBMs and health plans;and employers and government agencies who hire MCOs to provide health benefits to their employees.In the U.S.,we market directly to consumers through direct-to-
179、consumer advertising that seeks to communicate the approved uses,benefits and risks of our products while motivating people to have meaningful conversations with their doctors.In addition,we sponsor general advertising to educate the public on disease awareness,prevention and wellness,important publ
180、ic health issues and our patient assistance programs.As part of our commitment to engaging our customers in the manner they prefer,we took a hybrid approach of virtual and in person engagements and see positive customer response to both approaches.During the COVID-19 pandemic,we adapted our promotio
181、nal platform by amplifying our digital capabilities to reach healthcare professionals and customers to provide critical education and information,including increasing the scale of our remote engagement.PATENTS AND OTHER INTELLECTUAL PROPERTY RIGHTSPatents.We own or license a number of patents coveri
182、ng pharmaceutical and other products,their uses,formulations,and product manufacturing processes.Patents for individual products extend for varying periods according to the date of patent filing or grant and the legal term of patents in the various countries where patent protection is obtained.The s
183、cope of protection afforded by a patent can vary from country to country and depends on the patent type,the scope of its patent claims and the availability of legal remedies.Patent term extensions(PTE)may be available in some countries to compensate for a loss of patent term due to delay in a produc
184、ts approval due to the regulatory requirements.One of the primary considerations in limiting our operations in some countries outside the U.S.is the lack of effective intellectual property protection for our products,although international and U.S.free trade agreements have included some global prot
185、ection of intellectual property rights.For additional information,see the Item 1.BusinessGovernment Regulation and Price Constraints section in this Form 10-K.In various markets,a period of regulatory exclusivity may be provided for drugs or vaccines upon approval.The scope and term of such exclusiv
186、ity will vary but,in general,the period will run concurrently with the term of any existing patent rights associated with the drug at the time of approval.Pfizer Inc.2022 Form 10-K6Based on current sales,and considering the competition with products sold by our competitors,the patent rights we consi
187、der most significant in relation to our business as a whole,together with the year in which the basic product patent expires,are as follows:ProductU.S.Basic Product Patent Expiration Year(1)Major Europe Basic Product Patent Expiration Year(1)Japan Basic Product Patent Expiration Year(1)Inlyta2025202
188、52025Xeljanz20252028(2)2025Prevnar 13/Prevenar 132026(3)2029Eliquis(4)202620262026Ibrance202720282028Xtandi(5)2027(5)(5)Vyndaqel/Vyndamax/Vynmac2024 (2028 pending PTE)20262026/2029(6)Xalkori202920272028Nurtec ODT/Vydura2030 (2034 pending PTE)2030 (2035 pending SPC)2030(7)Braftovi(8)2030 (2031 pendin
189、g PTE)(8)(8)Mektovi(8)2031(9)(8)(8)Ngenla(10)(7)(11)2032(2)2030(2)Oxbryta20332032 (2037 pending SPC)2032(7)Lorbrena203320342036Prevnar 20/Apexxnar2033 (2035 pending PTE)2033 (2037 pending SPC)2033(7)Cibinqo2034 (2036 pending PTE)2034 (2036 pending SPC)2034 (2038 pending PTE)Pfizer-BioNTech COVID-19
190、Vaccine(12)(12)(13)(12)Paxlovid204120412041Pfizer-BioNTech COVID-19 Vaccine,Bivalent(Original and Omicron BA.4/BA.5)/Comirnaty Original/Omicron BA.1 Vaccine(12)(12)(13)(12)(1)Unless otherwise indicated,the years pertain to the basic product patent expiration,including granted PTEs,supplementary prot
191、ection certificates(SPC)or pediatric exclusivity periods.SPCs are included when granted in three out of five major European markets(France,Germany,Italy,Spain and the U.K.).Noted in parentheses is the projected year of expiry of the earliest pending patent term extension in the U.S.or Japan and/or S
192、PC application in Europe,the term of which,if granted,may be shorter than originally requested due to a number of factors.In some instances,there are later-expiring patents relating to our products which may or may not protect our product from generic or biosimilar competition after the expiration o
193、f the basic patent.(2)Expiry is provided by regulatory exclusivity in this market.(3)The Europe patent that covers the combination of the 13 serotype conjugates of Prevenar 13 was revoked following an opposition and has now been withdrawn.There are other Europe patents and pending applications cover
194、ing the formulation,various aspects of the manufacturing process,and the combination of serotype conjugates of Prevenar 13 that remain in force.(4)Eliquis was developed and is being commercialized in collaboration with BMS.In the U.S.,we and BMS previously settled certain patent litigations with a n
195、umber of generic companies permitting their launch of a generic version of Eliquis on April 1,2028(the settled generic companies).We continued to litigate against three remaining generic companies and following the resolution of the litigation in our favor,the three generic companies are not permitt
196、ed to launch their products until the 2031 expiration date of the formulation patent.Both the composition of matter patent expiring in November 2026 and the formulation patent expiring in 2031 may be subject to future challenges.While we cannot predict the outcome of any potential future litigation,
197、there are certain potential alternatives that might occur which could potentially permit generic launch prior to April 1,2028:(a)if the formulation patent is held invalid or not infringed in future litigation,through appeal,the settled generic companies and any successful future litigant would be pe
198、rmitted to launch on November 21,2026;or(b)if both patents are held invalid or not infringed in future litigation,through appeal,the settled generic companies and any successful future litigant could launch products immediately upon such an adverse decision.Refer to Note 16A1 for more information.(5
199、)Xtandi is being developed and commercialized in collaboration with Astellas,which has exclusive commercialization rights for Xtandi outside the U.S.Pfizer receives tiered royalties as a percentage of international Xtandi net sales.(6)Vyndaqel(tafamidis meglumine)basic patent expiry in Japan is Augu
200、st 2026 for treatment of polyneuropathy.Vynmac(tafamidis)was approved in Japan for treatment of cardiomyopathy with regulatory exclusivity expiring in March 2029.(7)Product not yet approved or authorized in this market.(8)We have exclusive rights to Braftovi and Mektovi in the U.S.,Canada and certai
201、n emerging markets.The Pierre Fabre Group has exclusive rights to commercialize both products in Europe and Ono has exclusive rights to commercialize both products in Japan.We receive royalties from The Pierre Fabre Group and Ono on sales of Braftovi and Mektovi in majority of markets outside the U.
202、S.(9)Mektovi U.S.expiry is provided by a method of use patent.(10)Ngenla is being developed in collaboration with OPKO.(11)Expiry expected to be provided by regulatory exclusivity in this market.(12)The basic product patent application has been filed in these markets.If granted,a full term is expect
203、ed in these markets.Product is being developed and commercialized in collaboration with BioNTech.(13)Pfizer does not have co-promotion rights for this product in Germany.Loss of Intellectual Property Rights.The loss,expiration or invalidation of intellectual property rights,patent litigation settlem
204、ents and the expiration of co-promotion and licensing rights can have a material adverse effect on our revenues.Once patent protection has expired or has been lost prior to the expiration date as a result of a legal challenge,we typically lose exclusivity on these products,and generic and biosimilar
205、 pharmaceutical manufacturers generally produce identical or highly similar products and sell them for a lower price.The date at which generic or Pfizer Inc.2022 Form 10-K7biosimilar competition commences may be different from the date that the patent or regulatory exclusivity expires.However,when g
206、eneric or biosimilar competition does commence,the resulting price competition can substantially decrease our revenues for the impacted products,often in a very short period of time.Also,if one of our product-related patents is found to be invalid by judicial,court or regulatory or administrative pr
207、oceedings,generic or biosimilar products could be introduced,resulting in the erosion of sales of our existing products.We continue to vigorously defend our patent rights against infringement,and we will continue to support efforts that strengthen worldwide recognition of patent rights while taking
208、necessary steps to help ensure appropriate patient access.For additional information,see the Item 1A.Risk FactorsCompetitive Products,Intellectual Property Protection and Third-Party Intellectual Property Claims sections in this Form 10-K and Note 16A1.Certain of our products have experienced patent
209、-based expirations or loss of regulatory exclusivity in certain markets in the last few years,and we expect certain products to face increased generic competition over the next few years.For example,the basic product patent for Sutent expired in the U.S.in 2021 and in Europe in 2022.There is no assu
210、rance that a particular product will enjoy market exclusivity for the full time period that appears in the estimates included in this Form 10-K or that we assume when we provide our financial guidance.For additional information on the impact of LOEs on our revenues,see the Overview of Our Performanc
211、e,Operating Environment,Strategy and OutlookOur 2022 Performance section within MD&A.Trademarks.Our products are sold under brand-name and logo trademarks and trade dress.Registrations generally are for fixed,but renewable,terms and protection is provided in some countries for as long as the mark is
212、 used while in others,for as long as it is registered.Protecting our trademarks is of material importance to Pfizer.COMPETITIONOur business is conducted in intensely competitive and often highly regulated markets.Many of our products face competition in the form of branded or generic drugs or biosim
213、ilars that treat similar diseases or indications.The principal forms of competition include efficacy,safety,ease of use and cost.Though the means of competition vary among our products,demonstrating the value of our products is a critical factor for success.We compete with other companies that manuf
214、acture and sell products that treat or prevent diseases or indications similar to those treated or prevented by our major products.These competitors include other worldwide research-based biopharmaceutical companies,smaller research companies with more limited therapeutic focus and generic drug and
215、biosimilar manufacturers.Our competitors also may devote substantial funds and resources to R&D and their successful R&D could result in erosion of the sales of our existing products and potential sales of products in development,as well as unanticipated product obsolescence.In addition,several of o
216、ur competitors operate without large R&D expenses and make a regular practice of challenging our product patents before their expiration.To address competitive trends we continually emphasize innovation,which is underscored by our multi-billion-dollar investment in R&D,as well as our business develo
217、pment transactions,both designed to result in a strong and differentiated product pipeline.Our investment in research continues even after drug or vaccine approval as we seek to further demonstrate the value of our products for the conditions they treat or prevent,as well as potential new applicatio
218、ns.We educate patients,physicians,payers and global health authorities on the benefits and risks of our medicines and vaccines,and seek to continually enhance the organizational effectiveness of our biopharmaceutical functions,including to accurately and ethically launch and market our products to o
219、ur customers.Operating conditions have also shifted as a result of increased global competitive pressures,industry regulation and cost containment.We continue to evaluate,adapt and improve our organization and business practices in an effort to better meet customer and public needs.We believe that w
220、e have taken an industry-leading role in evolving our approaches to U.S.direct-to-consumer advertising,interactions with,and payments to,healthcare professionals and medical education grants.We also continue to sponsor programs to address patient affordability and access barriers,as we strive to adv
221、ance fundamental health system change through our support for better healthcare solutions.Our vaccines may face competition,including from the introduction of alternative vaccines or“next-generation”vaccines prior to or after the expiration of their patents,which may adversely affect our future resu
222、lts.Our biosimilars,which include biosimilars of certain inflammation&immunology and oncology biologic medicines,compete with branded products from competitors,as well as other generics and biosimilars manufacturers.We seek to maximize the opportunity to establish a“first-to-market”or early market p
223、osition for our biosimilars to provide customers a lower-cost alternative immediately when available and also to potentially provide us with higher levels of sales and profitability until other competitors enter the market.Generic Products.Generic pharmaceutical manufacturers pose one of the biggest
224、 competitive challenges to our branded small molecule products because they can market a competing version of our product after the expiration or loss of our patent and often charge much less.Several competitors regularly challenge our product patents before their expiration.Generic competitors ofte
225、n operate without large R&D expenses,as well as without costs of conveying medical information about products to the medical community.In addition,the FDA approval process exempts generics from costly and time-consuming clinical trials to demonstrate their safety and efficacy,allowing generic manufa
226、cturers to rely on the safety and efficacy data of the innovator product.In China,for example,we expect to continue to face intensified competition by certain generic manufacturers in 2023 and beyond,which may result in price cuts and volume loss of some of our products.In addition,generic versions
227、of competitors branded products may also compete with our products.MCOs that focus primarily on the immediate cost of drugs often favor generics over brand-name drugs.Many governments also encourage the use of generics as alternatives to brand-name drugs in their healthcare programs,including Medica
228、id in the U.S.,and U.S.laws generally allow,and in some cases require,pharmacists to substitute generic drugs for brand-name drugs.In a small subset of states,prescribing physicians are able to expressly prevent such substitution.Biosimilars.Certain of our biologic products,including Enbrel(we marke
229、t Enbrel outside the U.S.and Canada),already face,or may face in the future,competition from biosimilars(also referred to as follow-on biologics).Biosimilars are versions of biologic medicines that have been developed and proven to be highly similar to the original biologic in terms of safety and ef
230、ficacy and that have no clinically meaningful differences in safety,purity or potency.Biosimilars have the potential to offer high-quality,lower-cost alternatives to innovative biologic medicines.In the U.S.,biosimilars referencing innovative biologic products are approved under the U.S.Public Healt
231、h Service Act.Pfizer Inc.2022 Form 10-K8PRICING PRESSURES AND MANAGED CARE ORGANIZATIONSCommercial Pricing Pressures.Pricing and access pressures in the commercial sector continue to be significant.Overall,there is increasing pressure on U.S.providers to deliver healthcare at a lower cost and to ens
232、ure that those expenditures deliver demonstrated value in terms of health outcomes.Many employers have adopted or make available high deductible health plans,which can increase out-of-pocket costs for medicines.This trend is likely to continue.Private third-party payers,such as health plans,increasi
233、ngly challenge pharmaceutical product pricing,which could result in lower prices,lower reimbursement rates for payors and a reduction in demand for our products,including denial of coverage of our products,if lower cost alternatives are available.Pricing pressures also may occur as a result of highl
234、y competitive insurance markets.Healthcare provider purchasers,directly or through group purchasing organizations,are seeking enhanced discounts or implementing more rigorous bidding or purchasing review processes.Longer term,we foresee a shift among payors and their pharmacy benefits managers in fo
235、cus away from fee-for-service reimbursement towards outcomes-based payments and risk-sharing arrangements that reward providers and pharmaceutical manufacturers for cost reductions and improved patient outcomes.These new payment models can,at times,lead to lower prices for,and restricted access to,n
236、ew medicines.At the same time,these models can also promote utilization of drugs by encouraging physicians to screen and diagnose and consider drugs as a means of forestalling more costly medical interventions.Further,these models may also encourage payors and their pharmacy benefits managers to cov
237、er higher cost drugs where coverage is tied to patient outcomes and other quality incentives.The impact of COVID-19 and related large-scale healthcare disruptions on the pace of adoption of value-based payment models remains unclear.Both payors and providers may resist adopting such models or choose
238、 to adopt such models at a slower pace if the incentives available do not outweigh the financial risk involved.Unprecedented pressures on critical care and the reductions in elective surgeries during the COVID-19 pandemic undermined revenue predictability for hospitals and other institutional provid
239、ers.As a result,providers may weigh their ability to take on the financial risk of downside value-based payment models.In contrast,providers in more advanced value-based payment models,such as full capitation,a fixed amount paid in advance per patient per unit of time-period,generally found their re
240、venues remained steady during the pandemic,which may ultimately encourage the growth of such models.Going forward,we expect continued focus on value-based payment models that support financial resiliency and advance health care equity by incorporating features intended to reduce disparities in healt
241、h care quality and access experienced by underrepresented and underserved populations.We believe medicines and vaccines are the most efficient and effective use of healthcare dollars based on the value they deliver to the overall healthcare system.We work with law makers and advocate for solutions t
242、hat effectively improve patient health outcomes,lower costs to the healthcare system,and help ensure access to medicines and vaccines within an efficient and affordable healthcare system.This includes assessing our go-to market model to address patient affordability challenges.We have engaged with m
243、ajor payors and the U.S.government to explore opportunities to improve access and reimbursement in an effort to drive pro-patient policies.In addition,in response to the evolving U.S.and global healthcare spending landscape,we work with health authorities,health technology assessment and quality mea
244、surement bodies and major U.S.payers throughout the product-development process to better understand how these entities value our compounds and products.Further,we are developing stronger support to demonstrate the net value of the medicines and vaccines that we discover or develop,register and manu
245、facture.For information on government pricing pressures,see the Item 1.BusinessGovernment Regulation and Price Constraints and Item 1A.Risk FactorsPricing and Reimbursement sections in this Form 10-K.Managed Care Organizations.The evolution of managed care in the U.S.has been a major factor in the c
246、ompetitiveness of the healthcare marketplace.Approximately 307 million people in the U.S.now have some form of health insurance coverage,and the marketing of prescription drugs and vaccines to both consumers and the entities that manage coverage in the U.S.continues to grow in importance.In particul
247、ar,the influence of MCOs has increased in recent years due to the growing number of patients receiving coverage through MCOs.At the same time,consolidation in the MCO industry has resulted in fewer,even larger MCOs,which enhances those MCOs ability to negotiate lower pricing and further increases th
248、eir importance to our business.Since MCOs seek to contain and reduce healthcare expenditures,their growing influence has increased downward pressure on drug prices,as well as negatively impacted revenues.MCOs and their PBMs typically negotiate prices with pharmaceutical providers by using formularie
249、s(which are lists of approved medicines available to MCO members),clinical protocols(which require prior authorization for a branded product if a generic product is available or require the patient to first fail on one or more generic products before permitting access to a branded medicine),volume p
250、urchasing,long-term contracts and their ability to influence volume and market share of prescription drugs.In addition,by placing branded medicines on higher-tier or non-preferred status in their formularies,MCOs transfer to the patient higher patient out-of-pocket expenses.This financial disincenti
251、ve is a tool for MCOs to manage drug costs and channel patients to medicines preferred by the MCOs.We expect payment reforms for MCOs will continue to evolve with increased emphasis on expanded participation and on removing barriers to equitable health care.The breadth of the products covered by for
252、mularies can vary considerably from one MCO to another,and many formularies include alternative and competitive products for treatment of particular medical problems.MCOs emphasize primary and preventive care,out-patient treatment and procedures performed at doctors offices and clinics as ways to ma
253、nage costs.Hospitalization and surgery,typically the most expensive forms of treatment,are carefully managed,and drugs that can help in chronic care management and reduce the need for hospitalization,professional therapy or surgery may become favored first-line treatments for certain diseases.At the
254、 same time,MCOs may seek to exclude high-cost drugs from formularies in their efforts to manage and lower their costs.Exclusion of a product from a formulary or other MCO-implemented restrictions can significantly impact drug usage in the MCO patient population and beyond.Consequently,pharmaceutical
255、 companies compete to gain access to formularies for their products,typically on the basis of unique product features,such as greater efficacy,better patient ease of use,or fewer side effects,as well as the overall cost of the therapy.We continue to seek to ensure that our major products are include
256、d on MCO formularies.However,increasingly our branded products are being placed on the higher tiers or in a non-preferred status.For additional information,see the Item 1A.Risk FactorsManaged Care Trends section in this Form 10-K.RAW MATERIALSWe procure raw materials essential to our business from n
257、umerous suppliers worldwide.In general,these materials have been available in sufficient quantities to support our demand and in many cases are available from multiple suppliers.No significant impact to our operations due to the availability of raw materials is currently anticipated in 2023.However,
258、we are seeing an increase in overall demand in the industry for certain components and raw materials,which could potentially result in constraining available supply leading to a possible future impact on our Pfizer Inc.2022 Form 10-K9business.We are continuing to monitor and implement mitigation str
259、ategies in an effort to reduce any potential risk or impact,including active supplier management,qualification of additional suppliers and advanced purchasing to the extent possible.GOVERNMENT REGULATION AND PRICE CONSTRAINTSWe are subject to extensive regulation by government authorities in the cou
260、ntries in which we do business.This includes laws and regulations governing the operations of biopharmaceutical companies,such as the approval,manufacturing and marketing of products,pricing(including discounts and rebates)and data privacy,among others.These laws and regulations may require administ
261、rative guidance for implementation,and a failure to comply could subject us to legal and/or administrative actions.Enforcement measures may include substantial fines and/or penalties,orders to stop non-compliant activities,criminal charges,warning letters,product recalls or seizures,delays in produc
262、t approvals,exclusion from participation in government programs or contracts as well as limitations on conducting business in applicable jurisdictions,and could result in harm to our reputation and business.For additional information,see Note 16A.Compliance with these laws and regulations may be cos
263、tly,and may require significant technical expertise and capital investment to ensure compliance.While capital expenditures or operating costs for compliance with government regulations cannot be predicted with certainty,we do not currently anticipate they will have a material effect on our capital e
264、xpenditures or competitive position.In the United StatesDrug and Biologic Regulation.The FDA,pursuant to the FFDCA,the Public Health Service Act and other federal statutes and regulations,extensively regulates pre-and post-marketing activities related to our biopharmaceutical products.The regulation
265、s govern areas such as the safety and efficacy of medicines and vaccines,clinical trials,advertising and promotion,quality control,manufacturing,labeling,distribution,post-marketing safety surveillance and reporting,and record keeping.Other U.S.federal agencies,including the DEA,also regulate certai
266、n of our products and activities.For a biopharmaceutical company to market a drug or a biologic product,including vaccines,in the U.S.,the FDA must evaluate whether the product is safe and effective for its intended use.If the FDA determines that the drug or biologic is safe and effective,the FDA wi
267、ll approve the products NDA or BLA(or supplemental NDA or supplemental BLA),as appropriate.A drug or biologic may be subject to postmarketing commitments,which are studies or clinical trials that the product sponsor agrees to conduct,or postmarketing requirements,which are studies or clinical trials
268、 that are required as a condition of approval.In addition,we are also required to report adverse events and comply with cGMP(the FDA regulations that govern all aspects of manufacturing quality for pharmaceuticals)and the Drug Supply Chain Security Act(the law that,among other things,sets forth requ
269、irements related to product tracing,product identifiers and verification for manufacturers,wholesale distributors,repackagers and dispensers to facilitate the tracing of product through the pharmaceutical distribution supply chain),as well as advertising and promotion regulations.For additional info
270、rmation,see the Item 1A.Risk FactorsDevelopment,Regulatory Approval and Marketing of Products and Post-Authorization/Approval Data sections in this Form 10-K.In the context of public health emergencies,like the COVID-19 pandemic,we may apply to the FDA for an EUA,which,if granted,allows for the dist
271、ribution and use of our products during the declared emergency,in accordance with the conditions set forth in the EUA,unless the EUA is terminated by the government.Although the criteria for an EUA differ from the criteria for approval of an NDA or BLA,EUAs nevertheless require the development and s
272、ubmission of data to satisfy the relevant FDA standards,and a number of ongoing obligations.The FDA generally expects EUA holders to work toward submission of full applications,such as a BLA or an NDA,as soon as possible.Biosimilar Regulation.The FDA is responsible for approval of biosimilars.Innova
273、tor biologics,or reference products,are entitled to 12 years exclusivity.Applications for biosimilars may not be submitted until four years after the date on which the reference product was first licensed and may not be approved until 12 years after the reference product was first licensed.Sales and
274、 Marketing Regulations.Our marketing practices are subject to state laws,as well as federal laws,such as the Anti-Kickback Statute and False Claims Act,intended to prevent fraud and abuse in the healthcare industry.The Anti-Kickback Statute prohibits corruptly soliciting,offering,receiving,or paying
275、 anything of value to generate business.The False Claims Act generally prohibits anyone from knowingly and willingly presenting,or causing to be presented,any claims for payment for goods or services,including to government payers,such as Medicare and Medicaid,that are false or fraudulent and genera
276、lly treat claims generated through kickbacks as false or fraudulent.The federal government and states also regulate sales and marketing activities and financial interactions between manufacturers and healthcare providers,requiring disclosure to government authorities and the public of such interacti
277、ons,and the adoption of compliance standards or programs.State attorneys general have also taken action to regulate the marketing of prescription drugs under state consumer protection and false advertising laws.Pricing,Reimbursement and Access Regulations.Pricing and reimbursement for our products d
278、epend in part on government regulation.Any significant efforts at the federal or state levels to reform the healthcare system by changing the way healthcare is provided or funded or more directly impose controls on drug pricing,government reimbursement,and access to medicines and vaccines on public
279、and private insurance plans could have a material impact on us.In addition,in order to have our products covered by Medicaid,we must offer discounts or rebates on purchases of pharmaceutical products under various federal and state programs.We also must report specific prices to government agencies.
280、The calculations necessary to determine the prices reported are complex and the failure to do so accurately may expose us to enforcement measures.See the discussion regarding rebates in the Revenue Deductions section within MD&A and Note 1G.Government and private payers routinely seek to manage util
281、ization and control the costs of our products,and there is considerable public and government scrutiny of pharmaceutical pricing.Efforts by states and the federal government to regulate prices or payment for pharmaceutical products,including proposed actions to facilitate drug importation,limit reim
282、bursement to lower international reference prices,require deep discounts,and require manufacturers to report and make public price increases and sometimes a written justification for the increase,could adversely affect our business if implemented.We expect to see continued focus by Congress and the
283、Biden Administration on regulating pricing,which could result in legislative and regulatory changes designed to control costs.For example,in August 2022,the IRA was signed into law,which,among other things,requires manufacturers of certain drugs to engage in price negotiations with Medicare(beginnin
284、g in 2026),imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation(first due in 2023),and replaces the Part D coverage gap discount program with a new discounting program(beginning in 2025).We continue to evaluate the impact of the IRA on our busi
285、ness,operations and financial condition and results as the full effect of the IRA on our business and the pharmaceutical industry remains uncertain.In addition,changes to the Medicaid program or the federal 340B drug pricing program,which imposes ceilings on prices that drug manufacturers can charge
286、 for medications sold to certain health care facilities,could have a material impact on our business.For example,Pfizer Inc.2022 Form 10-K10certain changes finalized by the CMS in December 2020 for the Medicaid Drug Rebate Program may increase our Medicaid liability,including for drugs that are cons
287、idered to be“new formulations”of existing drugs.Additional changes to the 340B program are undergoing review and their status is unclear.In 2022,we implemented a policy that will help improve contract pharmacy integrity.The HHS has sent letters to numerous manufacturers that have also implemented co
288、ntract pharmacy integrity initiatives expressing the view that their programs are in violation of the 340B statute,and referring those programs for potential enforcement action.Several manufacturers have challenged HHSs enforcement letters in federal court and litigation is ongoing in those cases.We
289、 believe that our program is consistent with the statute.Additional legal or legislative developments at the federal or state level with respect to the 340B program may have an adverse impact on our integrity initiative,and we may face enforcement action or penalties,depending upon such developments
290、.For additional information,see the Item 1A.Risk FactorsPricing and Reimbursement section in this Form 10-K.A majority of states use preferred drug lists to manage access to pharmaceutical products under Medicaid,including some of our products.For example,access to our products under the Medicaid ma
291、naged care programs typically is determined by the health plans with which state Medicaid agencies contract to provide services to beneficiaries.States seek to control healthcare costs related to Medicaid and other state healthcare programs,including the implementation of supplemental rebate agreeme
292、nts under the Medicaid drug rebate program tied to patient outcomes.States budgets were impacted less by the COVID-19 pandemic than expected and are generally growing.However,we expect states will continue to seek cost cutting within Medicaid,which may focus on managed care capitation payments and/o
293、r formulary management.States may also advance drug-pricing initiatives with a focus on affordability review boards,financial penalties related to pricing practices,manufacturer pricing and reporting requirements,as well as regulation of prescription drug assistance,copay accumulator,or copay maximi
294、zer programs in the commercial market.Payers may promote generic drugs and biosimilars more aggressively to generate savings and attempt to stimulate additional price competition.In addition,we expect that consolidation and integration among pharmacy chains,wholesalers and PBMs will increase pricing
295、 pressures in the industry.For additional information,see the Item 1A.Risk FactorsManaged Care Trends section in this Form 10-K.Anti-Corruption.The FCPA prohibits U.S.corporations and their representatives from offering,promising,authorizing or making payments to any foreign government official,gove
296、rnment staff member,political party or political candidate to obtain or retain business abroad.The scope of the FCPA includes interactions with certain healthcare professionals in many countries.Other countries have enacted similar anti-corruption laws and/or regulations.Data Privacy.The collection
297、and use of personal data by us is increasingly important to our business and is subject to various federal and state privacy and data security laws and regulations,including oversight by various regulatory and other governmental bodies.Such laws and regulations continue to evolve and are increasingl
298、y being enforced vigorously.Outside the United StatesNew Drug Approvals.In the EU,the EMA conducts the scientific evaluation,supervision and safety monitoring of our innovative medicinal products,and employs a centralized procedure for approval for the EU and the European Economic Area(EEA)countries
299、.In the U.K.,the Medicines and Healthcare Products Regulatory Agency is the sole regulatory authority.In Japan,the Pharmaceuticals and Medical Device Agency is involved in a wide range of regulatory activities,including clinical studies,approvals,post-marketing reviews and pharmaceutical safety.In C
300、hina,the National Medical Product Administration is the primary regulatory authority for approving and supervising medicines.Health authorities in many middle-and lower-income countries require marketing approval by a recognized regulatory authority(e.g.,the FDA or EMA)before they begin to conduct t
301、heir application review process and/or issue their final approval.Pharmacovigilance.In the EU,the EMAs PRAC is responsible for reviewing and making recommendations on product safety issues.Outside developed markets,pharmacovigilance requirements vary and are generally not as extensive,but there is a
302、 trend toward increasing regulation.Pricing and Reimbursement.Certain governments,including in the different EU member states,the U.K.,Japan,China,Canada and South Korea,provide healthcare at low-to-zero direct cost to consumers at the point of care and have significant power to regulate pharmaceuti
303、cal prices or patient reimbursement levels to control costs for the government-sponsored healthcare system,particularly under recent global financing pressures.Governments globally may use a variety of measures to control costs,including,among others,proposing price reform or legislation,cross count
304、ry collaboration and procurement,price cuts,mandatory rebates,health technology assessments,forced localization as a condition of market access,“international reference pricing”(i.e.,the practice of a country linking its regulated medicine prices to those of other countries),QCE processes and VBP.In
305、 addition,the international patchwork of price regulation,differing economic conditions and incomplete value assessments across countries has led to varying access to quality medicines in many markets and some third-party trade in our products between countries.Several important multilateral organiz
306、ations such as the World Health Organization are increasing scrutiny of international pharmaceutical pricing through policy recommendations and sponsorship of programs,such as“The Oslo Medicines Initiative”which aims to ensure“affordability for high-priced medicines”.In November 2020,the EC publishe
307、d its Pharmaceutical Strategy for Europe which envisions a broad range of new initiatives and legislation including a significant focus on tackling the persisting inequalities on access,affordability and availability of medicines across the EU.In China,pricing pressures have increased in recent year
308、s because of an overall focus on healthcare cost containment with the central government emphasizing improved health outcomes and decreased drug prices as key indicators of progress towards its healthcare reform.For patented products,drug prices have decreased dramatically as a result of adding inno
309、vative drugs(including oncology medicines and orphan drugs)to the National Reimbursement Drug List(NRDL)via access-price negotiation.In the off-patent space,numerous local generics have been officially deemed bioequivalent under a QCE process that required generic drugs to pass a test to assess thei
310、r bioequivalence to a qualified reference drug(typically the originator drug).A centralized VBP programa tendering process where a certain portion of included molecule volumes are guaranteed to tender winnersaims to contain healthcare costs by driving utilization of generics that have passed QCE.Thi
311、s has resulted in further lowering the price of medicines,especially off-patent medicines;this trend is expected to continue.Furthermore,the Chinese government has promulgated price bidding rules in June 2022 for enlisting off-patent products(excluding VBP products and certain products directly pric
312、ed by government)onto the NRDL with the goal of unifying the reimbursement price between QCE-approved generic medicines and the applicable original medicines.Pfizer,along with most off-patent originators,have mostly not been successful in the VBP bidding process.The government has indicated that add
313、itional post-LOE drugs(including biological products)could be subjected to VBP qualification in future rounds.Certain of our products,such as Sulperazon and Vfend injectables,are likely to be included in future rounds.While certain details of future QCE expansion have been made available,we are unab
314、le to determine the impact on our business and financial condition until the initiation of these future rounds.Pfizer Inc.2022 Form 10-K11Healthcare Provider Transparency and Disclosures.Several countries have implemented laws requiring(or industry trade associations have recommended)disclosure of t
315、ransfers of value made by pharmaceutical companies to healthcare providers and/or healthcare organizations,such as academic teaching hospitals.Intellectual Property.Reliable patent protection and enforcement around the world are among the key factors we consider for continued business and R&D invest
316、ment.The WTO Agreement on Trade Related Aspects of Intellectual Property Rights(WTO-TRIPS)requires participant countries to provide patent and other intellectual property-related protection for pharmaceutical products by law,with a time-limited exemption provided for least-developed countries.While
317、some countries have made improvements,we still face patent grant,enforcement and other intellectual property challenges in many countries.While the global intellectual property policy environment has generally improved following implementation of WTO-TRIPS and bilateral/multilateral trade agreements
318、,our growth and ability to bring new product innovation to patients depends on further progress in intellectual property protection.In certain developed international markets,governments maintain relatively effective intellectual property policies.However,in the EU,pursuant to the ongoing review of
319、pharmaceutical intellectual property and regulatory incentives,legislative proposals expected to be introduced in 2023 may result in the reduction of certain protections.In several emerging market countries,governments have used intellectual property policies as a tool to force innovators to accept
320、less than fair value for medicines,as well as to advance industrial policy and localization goals.The WTO continues to address the role of intellectual property in the context of the COVID-19 pandemic response.This includes the June 2022 Ministerial Decision on the Agreement on Trade-Related Aspects
321、 of Intellectual Property Rights,which seeks to make it easier for certain WTO members to issue a compulsory license on COVID-19 vaccines,and discussions continue on whether to expand that decision to COVID-19 therapeutics and diagnostics.Considerable political and economic pressure has weakened cur
322、rent intellectual property protection in some countries and has led to policies such as more restrictive standards for obtaining patents and more difficult procedures for patenting biopharmaceutical inventions,restrictions on patenting certain types of inventions,revocation of patents,laws or regula
323、tions that promote or provide broad discretion to issue a compulsory license,weak intellectual property enforcement and failure to implement effective regulatory data protection.Our industry advocacy efforts focus on seeking a fair and transparent business environment for foreign manufacturers,under
324、scoring the importance of strong intellectual property systems for local innovative industries and helping improve patients access to innovative medicines and vaccines.Data Privacy.Outside of the U.S.,many countries have privacy and data security laws and regulations concerning the collection and us
325、e of personal data,including but not limited to,the EUs General Data Protection Regulations and Chinas Personal Information Protection Law.The legislative and regulatory framework for privacy and data protection issues worldwide is also rapidly evolving as countries continue to adopt new and updated
326、 privacy and data security laws.The interpretation and application of such laws and regulations remain uncertain and continues to evolve.In addition,enforcement of such laws and regulations is increasing.ENVIRONMENTAL MATTERSOur operations are affected by national,state and/or local environmental la
327、ws.We have made,and intend to continue to make,the expenditures necessary for compliance with applicable laws.We also are cleaning up environmental contamination from past industrial activity at certain sites.We incurred capital and operational expenditures in 2022 for environmental compliance purpo
328、ses and for the clean-up of certain past industrial activity as follows:$88 million in environment-related capital expenditures and$148 million in other environment-related expenses.While capital expenditures or operating costs for environmental compliance cannot be predicted with certainty,we do no
329、t currently anticipate they will have a material effect on our capital expenditures or financial position.See also Note 16A3.As a science guided organization,we take a proactive approach to our environmental sustainability initiatives.In 2022,we announced a new goal to further reduce GHG emissions a
330、nd achieve the Science Based Target Initiatives voluntary Net-Zero Standard by 2040.As part of this goal,Pfizer aims to decrease its GHG emissions by 95%and its value chain emissions by 90%from 2019 levels by 2040.To support our goal,we are developing our emission reduction plan,which will include s
331、trategies to achieve reductions throughout our value chain including investing in new technologies and innovative climate solutions,and urging all of our suppliers to unite with us in making a commitment to action and integrating ambitious climate impact reduction targets into their management proce
332、sses.Related expenses and capital spending incurred for 2022 were not material to our consolidated financial statements.While capital and operational expenditures will be incurred to meet our goal,we do not currently anticipate they will have a material effect on our financial position in the near t
333、erm.Longer term uncertainties regarding availability of commercially available technologies among others make it difficult to predict the financial impact of meeting the goal and we will continue to assess and monitor the financial impact of the emission reduction plan.For a discussion of the risks associated with climate change and our environmental initiatives,see the Item 1A.Risk FactorsClimate