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 31,2023TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934F

2、or the transition period from toCommission file number 1-3619PFIZER 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(Ad

3、dress 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,$0.05 par valuePFENew York Stock Exchange1

4、.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 r

5、eports 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 12months(or for such shorter period that the registrant was req

6、uired 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 ofthis chapter)dur

7、ing 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.See t

8、he 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,indi

9、cate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financialaccounting standards provided pursuant to Section 13(a)of the Exchange Act.Indicate by check mark whether the registrant has filed a report on and attestation to

10、its managements assessment of the effectiveness of its internal control over financial reportingunder 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)of the

11、 Act,indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction ofan error to previously issued financial statements.Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incent

12、ive-based compensation received by any of the registrantsexecutive 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 voting stoc

13、k held by non-affiliates of the registrant,computed by reference to the closing price as of the last business day of the registrants mostrecently completed second fiscal quarter was approximately$207 billion.This excludes shares of common stock held by directors and executive officers.Exclusion of s

14、hares held byany 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 theregistrant,or that such person is controlled by or under common control with the registrant.The registrant has

15、no non-voting common stock.The number of shares outstanding of the registrants common stock as of February 15,2024 was 5,646,778,425 shares of common stock,all of one class.DOCUMENTS INCORPORATED BY REFERENCEPortions of the Proxy Statement for the 2024 Annual Meeting of ShareholdersPart IIITABLE OF

16、CONTENTS PageDefined TermsiAvailable InformationiiiForward-Looking Information and Factors that May Affect Future Results1PART I3ITEM 1.BUSINESS3About Pfizer3Commercial Operations4Research and Development4Collaboration and Co-Promotion Agreements5International Operations6Sales and Marketing6Patents

17、and Other Intellectual Property Rights7Competition10Pricing Pressures and Managed Care Organizations10Raw Materials11Government Regulation and Price Constraints11Environmental Matters14Our People15ITEM 1A.RISK FACTORS16ITEM 1B.UNRESOLVED STAFF COMMENTSN/AITEM 1C.CYBERSECURITY26ITEM 2.PROPERTIES27ITE

18、M 3.LEGAL PROCEEDINGS27ITEM 4.MINE SAFETY DISCLOSURESN/AINFORMATION ABOUT OUR EXECUTIVE OFFICERS28PART II29ITEM 5.MARKET FOR THE COMPANYS COMMON EQUITY,RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES29ITEM 6.RESERVED29ITEM 7.MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL COND

19、ITION AND RESULTS OF OPERATIONS30ITEM 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK49ITEM 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA50ITEM 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE107ITEM 9A.CONTROLS AND PROCEDURES107ITEM 9B.OTHER INFOR

20、MATION110ITEM 9C.DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONSN/APART III110ITEM 10.DIRECTORS,EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE110ITEM 11.EXECUTIVE COMPENSATION110ITEM 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS110

21、ITEM 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS,AND DIRECTOR INDEPENDENCE110ITEM 14.PRINCIPAL ACCOUNTING FEES AND SERVICES110PART IV110ITEM 15.EXHIBITS,FINANCIAL STATEMENT SCHEDULES11015(a)(1)Financial Statements11015(a)(2)Financial Statement Schedules11015(a)(3)Exhibits111ITEM 16.FORM 10-K S

22、UMMARY114SIGNATURES115N/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.For eachyear presented,Pfizers fiscal year-end for subsidiaries operating outside th

23、e U.S.is as of and for the year ended November 30 and for U.S.subsidiaries is as of and for the yearended December 31.References to“Notes”in this Form 10-K are to the Notes to the consolidated financial statements in Item 8.Financial Statements and Supplementary Data inthis Form 10-K.We also have us

24、ed 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 31,20232022 Form 10-KOur Annual Report on Form 10-K for the fiscal year ended December 31,2022Proxy StatementProxy Statement for the 2024

25、Annual Meeting of Shareholders,which will be filed no later than 120 days after December 31,2023ABOAccumulated benefit obligation;represents the present value of the benefit obligation earned through the end of the year but does not factor infuture compensation increasesACIPAdvisory Committee on Imm

26、unization PracticesADCAntibody-Drug ConjugateAlexionAlexion Pharma International Operations Limited,a subsidiary of AstraZeneca PLCALKanaplastic lymphoma kinaseAlliance revenuesRevenues from alliance agreements under which we co-promote products discovered or developed by other companies or usArenaA

27、rena Pharmaceuticals,Inc.ArrayArray 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 LimitedBioNTechBioNTech SEBiopharmaGlobal

28、Biopharmaceuticals BusinessBlackstoneBlackstone Life SciencesBLABiologics License ApplicationBMSBristol-Myers Squibb CompanyBODBoard of DirectorsCDCU.S.Centers for Disease Control and PreventioncGMPcurrent Good Manufacturing PracticesCGRPcalcitonin gene-related peptideCMSCenters for Medicare&Medicai

29、d ServicesComirnaty*Unless otherwise noted,refers to,as applicable,and as authorized or approved,the Pfizer-BioNTech COVID-19 Vaccine,the Pfizer-BioNTechCOVID-19 Vaccine,Bivalent(Original and Omicron BA.4/BA.5),Comirnaty(COVID-19 Vaccine,mRNA,2023-2024 Formula),the Pfizer-BioNTechCOVID-19 Vaccine(20

30、23-2024 Formula),Comirnaty Original/Omicron BA.1,Comirnaty Original/Omicron BA.4/BA.5 and Comirnaty XBB.1.5.Consumer Healthcare JVGSK Consumer Healthcare JVCOVID-19novel coronavirus disease of 2019DEAU.S.Drug Enforcement AgencyDeveloped EuropeIncludes the following markets:Western Europe,Scandinavia

31、n countries and FinlandDeveloped MarketsIncludes the following markets:U.S.,Developed Europe and Developed Rest of WorldDeveloped Rest of WorldIncludes the following markets:Japan,Canada,South Korea,Australia and New ZealandECEuropean CommissionEMAEuropean Medicines AgencyEmerging MarketsIncludes,bu

32、t is not limited to,the following markets:Asia(excluding Japan and South Korea),Latin America,Eastern Europe,Central Europe,theMiddle East,Africa and TurkeyEPSearnings per shareESGEnvironmental,Social and GovernanceESOPemployee stock ownership planEUEuropean UnionEUAemergency use authorizationExchan

33、ge ActSecurities Exchange Act of 1934,as amendedFASBFinancial Accounting Standards BoardFCPAU.S.Foreign Corrupt Practices ActFDAU.S.Food and Drug AdministrationFFDCAU.S.Federal Food,Drug and Cosmetic ActGAAPGenerally Accepted Accounting PrinciplesPfizer Inc.2023 Form 10-KiGBTGlobal Blood Therapeutic

34、s,Inc.GDFVgrant-date fair valueGenmabGenmab A/SGPDGlobal Product Development organizationGSKGSK plcHaleonHaleon plcHHSU.S.Department of Health and Human ServicesHIPAAHealth Insurance Portability and Accountability Act of 1996HospiraHospira,Inc.IPR&Din-process research and developmentIRAInflation Red

35、uction Act of 2022IRCInternal Revenue CodeIRSU.S.Internal Revenue ServiceITinformation technologyJVjoint ventureKingKing Pharmaceuticals LLC(formerly King Pharmaceuticals,Inc.)LIBORLondon Interbank Offered RateLOEloss of exclusivityMCOmanaged care organizationmCRCmetastatic colorectal cancermCRPCmet

36、astatic 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 Technologies,

37、Inc.MoodysMoodys Investors ServicemRNAmessenger ribonucleic acidMSAManufacturing Supply AgreementMylanMylan N.V.Mylan-Japan collaborationa pre-existing strategic collaboration between Pfizer and Mylan for generic drugs in Japan that terminated on December 21,2020NAVnet asset valueNDAnew drug applica

38、tionNimbusNimbusTherapeutics,LLCnmCRPCnon-metastatic castration-resistant prostate cancernmCSPCnon-metastatic castration-sensitive prostate cancerNSCLCnon-small cell lung cancerNYSENew York Stock ExchangeODToral disintegrating tabletOnoOno Pharmaceutical Co.,Ltd.OPKOOPKO Health,Inc.ORDOncology Resea

39、rch and DevelopmentOTCover-the-counterPaxlovid*an oral COVID-19 treatment(nirmatrelvir tablets and ritonavir tablets)PBMpharmacy benefit managerPBOProjected benefit obligation;represents the present value of the benefit obligation earned through the end of the year and factors in futurecompensation

40、increasesPC1Pfizer CentreOnePGSPfizer Global SupplyPharmaciaPharmacia LLC(formerly Pharmacia Corporation)PIEPfizer Investment Enterprises Pte.Ltd.(a wholly-owned finance subsidiary of Pfizer)PP&EProperty,plant and equipmentPRACPharmacovigilance Risk Assessment CommitteePRDPfizer Research and Develop

41、mentPrevnar familyIncludes Prevnar 20/Apexxnar(pediatric and adult)and Prevnar 13/Prevenar 13(pediatric and adult)PsApsoriatic arthritisQCEquality consistency evaluationRArheumatoid arthritisPfizer Inc.2023 Form 10-KiiRCCrenal cell carcinomaR&Dresearch and developmentReViralReViral Ltd.ROUright of u

42、seRSVrespiratory syncytial virusS&PStandard&PoorsSeagenSeagen Inc.and its subsidiariesSECU.S.Securities and Exchange CommissionSI&Aselling,informational and administrativeSMPASumitomo Pharma America,Inc.TakedaTakeda Pharmaceutical Company LimitedTax Cuts and Jobs Act or TCJALegislation commonly refe

43、rred to as the U.S.Tax Cuts and Jobs Act of 2017TrilliumTrillium Therapeutics ULC(formerly Trillium Therapeutics Inc.)TSAstransition service arrangementsUCulcerative colitisU.K.United KingdomUpjohn BusinessPfizers former global,primarily off-patent branded and generics business,which included a port

44、folio of 20 globally recognized solid oral dosebrands,including Lipitor,Lyrica,Norvasc,Celebrex and Viagra,as well as a U.S.-based generics platform,Greenstone,that was spun-off onNovember 16,2020 and combined with Mylan to create ViatrisU.S.United StatesValnevaValneva SEVBPvolume-based procurementV

45、iatrisViatris Inc.ViiVViiV Healthcare LimitedVyndaqel familyIncludes Vyndaqel,Vyndamax and VynmacWRDMWorldwide Research,Development and MedicalWTOWorld Trade OrganizationWyethWyeth LLC(formerly Wyeth)*The Pfizer-BioNTech COVID-19 Vaccine(2023-2024 Formula)and certain uses of Paxlovid have not been a

46、pproved or licensed by the FDA.The Pfizer-BioNTech COVID-19 Vaccine(2023-2024 Formula)has been authorized for emergency use by the FDA under an EUA to prevent COVID-19 in individuals aged 6 months through 11 years of age.Paxlovid has been authorized for emergency use by the FDAunder an EUA for the t

47、reatment of mild-to-moderate COVID-19 in pediatric patients(12 years of age and older weighing at least 40 kg)who are at high risk for progression to severe COVID-19,includinghospitalization or death.The emergency uses are only authorized for the duration of the declaration that circumstances exist

48、justifying the authorization of emergency use of the medical product during theCOVID-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 andwww.cvdvaccine-.This Form 10-K includes discussion of certain

49、 clinical studies relating to various in-line products and/or product candidates.These studies typically are part of a larger body of clinicaldata 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,clin

50、ical trial data aresubject to differing interpretations,and,even when we view data as sufficient to support the safety and/or efficacy 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

51、 altogether.Some amounts in this Form 10-K may not add due to rounding.All percentages have been calculated using unrounded amounts.All trademarks mentioned are the property of theirowners.AVAILABLE INFORMATIONOur website is .This Form 10-K,our Quarterly Reports on Form 10-Q,our Current Reports on F

52、orm 8-K and our proxy statements,and amendments to those reportsfiled 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 interactivedata file format,as soon as reasonably practicable after we

53、 electronically file this material 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 tothis information.This Form 10-K will be available on our webs

54、ite on or about February 22,2024.Our Proxy Statement will be available on our website on or about March 14,2024.Our 2023 Impact Report,which provides enhanced ESG disclosures,will be available on our website on or about March 14,2024.We also have a Pfizer Investor Insights website,which includes art

55、icles on the company,its products and its pipeline,located at .Information in our 2023 Impact Report and on the Pfizer Investor Insights websiteare 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 disclo

56、sure obligations under Regulation Fair Disclosure 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 tofollowing our press releases,SEC filings,public conferenc

57、e calls and webcasts,as well as our social media channels(our Facebook page,Instagram account(Pfizerinc),YouTubepage,LinkedIn page,and X(formerly known as Twitter)accounts(Pfizer and Pfizer_News).The information contained on our website,our Facebook,Instagram,YouTube andLinkedIn pages or our X accou

58、nts,or any third-party website,is not incorporated by reference 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 allof our employees,including our Chief Ex

59、ecutive Officer,Chief Financial Officer and Principal Accounting Officer);Code of Business Conduct and Ethics for Members of the Board ofDirectors;information concerning our Directors;ways toPfizer Inc.2023 Form 10-Kiiicommunicate by e-mail with our Directors;information concerning our Board Committ

60、ees;Committee Charters;Charter of the Lead Independent Director;and transactions in Pfizersecurities 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

61、East,New York,NY 10001-2192.We will disclose any future amendments to,or waivers from,provisions of the Pfizer Policies on BusinessConduct affecting our Chief Executive Officer,Chief Financial Officer,Principal Accounting Officer and executive officers on our website as promptly as practicable,as ma

62、y berequired under applicable SEC and NYSE rules.Information relating to shareholder services,including the Computershare Investment Program,book-entry share ownership anddirect deposit of dividends,is also available on our website.Pfizer Inc.2023 Form 10-KivFORWARD-LOOKING INFORMATION AND FACTORS T

63、HAT MAY AFFECT FUTURE RESULTSThis Form 10-K contains forward-looking statements.We also provide forward-looking statements in other materials we release to the public,as well as public oral statements.Giventheir forward-looking nature,these statements involve substantial risks,uncertainties and pote

64、ntially inaccurate assumptions.We have tried,wherever possible,to identify such statements 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,”“poten

65、tial,”“hope”and other words and terms of similar meaning or by using future dates.We include forward-looking information in our discussion of the following,among other topics:our anticipated operating and financial performance,including financial guidance and projections;reorganizations,business pla

66、ns,strategy,goals and prospects;expectations for our product pipeline,in-line products and product candidates,including anticipated regulatory submissions,data read-outs,study starts,approvals,launches,clinical trial results and other developing data;revenue contribution and projections;potential pr

67、icing and reimbursement;potential market dynamics,including patient demand,market size and utilization rates;and growth,performance,timing of exclusivity and potential benefits;strategic reviews,capital allocation objectives,dividends and share repurchases;plans for and prospects of our acquisitions

68、,dispositions and other business development activities,and our ability to successfully capitalize on growth opportunities and prospects;sales,expenses,interest rates,foreign exchange rates and the outcome of contingencies,such as legal proceedings;expectations regarding the impact of or changes to

69、existing or new government regulations or laws;our ability to anticipate and respond to and our expectations regarding the impact of macroeconomic,geopolitical,health and industry trends,pandemics,acts of war and otherlarge-scale crises;and manufacturing and product supply.In particular,forward-look

70、ing information in this Form 10-K includes statements relating to specific future actions,performance and effects,including,among others,the expectedbenefits of the organizational changes to our operations;our anticipated operating and financial performance;our ongoing efforts to respond to COVID-19

71、,including our plans andexpectations regarding Comirnaty and Paxlovid,and any potential future vaccines or treatments,including anticipated revenue and expectations for the commercial market forComirnaty and Paxlovid;our expectations regarding the impact of COVID-19 on our business;expected patent t

72、erms;the expected impact of patent expiries and generic andbiosimilar competition;the expected pricing pressures on our products and the anticipated impact to our business;the benefits expected from our business developmenttransactions,including our December 2023 acquisition of Seagen;our anticipate

73、d liquidity position;the anticipated costs,savings and potential benefits from certain of our initiatives,including our enterprise-wide Realigning our Cost Base program,which we launched in October 2023,and our Transforming to a More Focused Company program;our expectationsregarding the impact from

74、the 2023 tornado on our manufacturing facility in Rocky Mount,NC;our greenhouse gas emission reduction goals;our planned capital spending;and ourcapital allocation framework.Given their nature,we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole o

75、r in part.Actual outcomes may vary materially frompast results and those anticipated,estimated,implied or projected.These forward-looking statements may be affected by underlying assumptions that may prove inaccurate orincomplete,or by known or unknown risks and uncertainties,including those describ

76、ed in this section,in the Item 1A.Risk Factors section or in MD&A.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,futu

77、re events or otherwise,except as required by applicable securities law.You are advised,however,to consult anyfurther 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 secti

78、on and within MD&A.We note thesefactors 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,orwithin MD&A,or other risks currently unknown,could have a material adverse effect on ou

79、r business,financial condition or results of operations,or we may be required to increaseour 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 potentialrisks or uncertainties:Ris

80、ks 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 orclinical trials,regulatory submission dates,and/or regula

81、tory approval and/or launch dates;the possibility of unfavorable pre-clinical and clinical trial results,includingthe 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 orinterim da

82、ta;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 programs will

83、 be published in scientificjournal 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 fromregulators on a timely b

84、asis 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;uncertainties regarding the abil

85、ity to obtain,and the scope of,recommendations by technical or advisory committees,and the timing of,and ability to obtain,pricing approvals and product launches,all of which could impact theavailability or commercial potential of our products and product candidates;claims and concerns that may aris

86、e regarding the safety or efficacy of in-line products and product candidates,including claims and concerns that may arise from theoutcome of post-approval clinical trials,which could impact marketing approval,product labeling,and/or availability or commercial potential;Pfizer Inc.2023 Form 10-K1 th

87、e success and impact of external business development activities,such as the recent acquisition of Seagen,including the ability to identify and execute on potentialbusiness development opportunities;the ability to satisfy the conditions to closing of announced transactions in the anticipated time fr

88、ame or at all;the ability to realizethe anticipated benefits of any such transactions in the anticipated time frame or at all;the potential need for and impact of additional equity or debt financing to pursuethese opportunities,which has in the past and could in the future result in increased levera

89、ge and/or a downgrade of our credit ratings and could limit our ability to obtainfuture financing;challenges integrating the businesses and operations;disruption to business and operations relationships;risks related to growing revenues for certainacquired or partnered products;significant transacti

90、on 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 orprevent diseases and conditions similar to those treated or intended to be prevented by our in-line produc

91、ts 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 legal orregulatory a

92、ctions;the impact of public health outbreaks,epidemics or pandemics(such as COVID-19)on our business,operations and financial condition and results,including impactson our employees,manufacturing,supply chain,sales and marketing,R&D and clinical trials;risks and uncertainties related to our efforts

93、to continue to develop and commercialize Comirnaty and Paxlovid or any potential future COVID-19 vaccines,treatments orcombinations,as well as challenges related to their manufacturing,supply and distribution,including,among others,the risk that as the market for COVID-19 productscontinues to become

94、 more endemic and seasonal,demand for our COVID-19 products has and may continue to be reduced or not meet expectations,or may no longerexist,which has and may continue to lead to reduced revenues,excess inventory on-hand and/or in the channel which,for Paxlovid and Comirnaty,resulted insignificant

95、inventory write-offs in 2023 and could continue to result in inventory write-offs,or other unanticipated charges;challenges related to the transition to thecommercial market for our COVID-19 products;uncertainties related to the publics adherence to vaccines,boosters,treatments or combinations;and r

96、isks related toour ability to accurately predict or achieve our revenue forecasts for Comirnaty and Paxlovid or any potential future COVID-19 vaccines or treatments;trends toward managed care and healthcare cost containment,and our ability to obtain or maintain timely or adequate pricing or favorabl

97、e formulary placement for ourproducts;interest rate and foreign currency exchange rate fluctuations,including the impact of currency devaluations and monetary policy actions in countries experiencing highinflation or deflation rates;any significant issues involving our largest wholesale distributors

98、 or government customers,which account for a substantial portion of our revenues;the impact of the increased presence of counterfeit medicines,vaccines or other products in the pharmaceutical supply chain;any significant issues related to the outsourcing of certain operational and staff functions to

99、 third parties;any significant issues related to our JVs and other third-party business arrangements,including modifications related to supply agreements or other contracts withcustomers including governments or other payors;uncertainties related to general economic,political,business,industry,regul

100、atory and market conditions including,without limitation,uncertainties related to the impacton us,our customers,suppliers and lenders and counterparties to our foreign-exchange and interest-rate agreements of challenging global economic conditions,suchas inflation or interest rate fluctuations,and r

101、ecent and possible future changes in global financial markets;the exposure of our operations globally to possible capital and exchange controls,economic conditions,expropriation,sanctions and/or other restrictive governmentactions,changes in intellectual property legal protections and remedies,unsta

102、ble governments and legal systems and inter-governmental disputes;the impact of disruptions related to climate change and natural disasters,including uncertainties related to the impact of the tornado at our manufacturing facility inRocky Mount,NC in 2023;any changes in business,political and econom

103、ic conditions due to actual or threatened terrorist activity,geopolitical instability,political or civil unrest or military action,including the ongoing conflicts between Russia and Ukraine and in the Middle East and the resulting economic or other consequences;the impact of product recalls,withdraw

104、als and other unusual items,including uncertainties related to regulator-directed risk evaluations and assessments,including ourongoing 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 in

105、tangible 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 upf

106、ront costs but may fail to yield anticipated benefits and may result in unexpected costs,organizational disruption,adverse effects on employee morale,retention issues or other unintended consequences;the ability to successfully achieve our climate goals and progress our environmental sustainability

107、and other ESG priorities;Risks Related to Government Regulation and Legal Proceedings:the impact of any U.S.healthcare reform or legislation or any significant spending reduction or cost control efforts affecting Medicare,Medicaid or other publicly fundedor subsidized health programs,including the I

108、RA,or changes in the tax treatment of employer-sponsored health insurance that may be implemented;U.S.federal 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

109、.S.direct-to-consumer advertising;limitations onPfizer Inc.2023 Form 10-K2interactions with healthcare professionals and other industry stakeholders;as well as pricing pressures for our products as a result of highly competitivebiopharmaceutical markets;legislation or regulatory action in markets ou

110、tside of the U.S.,such as China or Europe,including,without limitation,laws related to pharmaceutical product pricing,intellectual property,medical regulation,environmental protections,reimbursement or access,including,in particular,continued government-mandated reductions inprices and access restri

111、ctions for certain biopharmaceutical products to control costs in those markets;legal defense costs,insurance expenses,settlement costs and contingencies,including without limitation,those related to actual or alleged environmentalcontamination;the risk and impact of an adverse decision or settlemen

112、t and risk related to the adequacy of reserves 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 IRA,changes in laws and regulations or their interpretation,includi

113、ng,among others,changes in tax laws and regulations internationally and in the U.S.,the adoption of global minimum taxation requirements outside the U.S.generallyeffective in most jurisdictions since January 1,2024 and potential changes to existing tax law by the current U.S.Presidential administrat

114、ion and Congress,including theproposed“Tax Relief for American Families and Workers Act of 2024”;Risks Related to Intellectual Property,Technology and Security:any significant breakdown or interruption of our IT systems and infrastructure(including cloud services);any business disruption,theft of co

115、nfidential or proprietary information,security threats on facilities or infrastructure,extortion or integrity compromise resulting from acyber-attack or other malfeasance by,but not limited to,nation states,employees,business partners or others;risks and challenges related to the use of artificial i

116、ntelligence-based software;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 begranted on a timely basis,if at all;and risks to our products,patents and other intellectual property,such

117、as:(i)claims of invalidity that could result in LOE;(ii)claims of patent infringement,including asserted and/orunasserted intellectual property claims;(iii)claims we may assert against intellectual property rights held by third parties;(iv)challenges faced by our collaboration or licensingpartners t

118、o the validity of their patent rights;or(v)any pressure,or legal or regulatory action by,various stakeholders or governments that could potentially result in us not seekingintellectual property protection or agreeing not to enforce or being restricted from enforcing intellectual property rights rela

119、ted 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 improvetheir lives through the discovery,developm

120、ent,manufacture,marketing,sale and distribution of biopharmaceutical products worldwide.We work across developed and emergingmarkets to advance wellness,prevention,treatments and cures that challenge the most feared diseases of our time.We collaborate with healthcare providers,governments andlocal c

121、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 onJune 2,1942.Most of our revenues come from the manufacture and sale of biopharmaceutical products.We also sell products for the detection

122、of certain illnesses and provide end-to-end R&Dservices to select innovative biotech companies.We believe that our medicines and vaccines provide significant value for healthcare providers and patients through improvedtreatment of diseases and improvements in health,wellness and productivity as well

123、 as by reducing other healthcare costs,such as emergency room visits or hospitalizations.Weseek to enhance the value of our medicines and vaccines and actively engage in dialogues about how we can best work with patients,physicians and payors to prevent and treatdisease and improve outcomes.We seek

124、to maximize patient access and evaluate our pricing arrangements and contracting methods with payors to minimize adverse impact onour revenues within the current legal and pricing structures.We are committed to fulfilling our purpose:Breakthroughs that change patients lives.Our purpose fuels everyth

125、ing we do and reflects both our passion for science and ourcommitment to patients.Our core business principles are:1.Trust is Everything2.Science Will Win3.Disruption Calls for Innovation4.Time is Life5.Execution Makes the Difference.In addition,Pfizers ESG strategy,which is integrated into our corp

126、orate strategy,focuses 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 opportuni

127、ties,primarily by advancing our own product pipeline and maximizing the value of our existing products,but alsothrough various business development activities.We view our business development activity as an enabler of our strategies and seek to generate growth by pursuing opportunitiesand transactio

128、ns that have the potential to strengthen our business and ourPfizer Inc.2023 Form 10-K3capabilities.We assess our business,assets and scientific capabilities/portfolio as part of our regular,ongoing portfolio review process and also continue to consider businessdevelopment activities that will help

129、advance our business strategy.On December 14,2023,we completed our acquisition of Seagen,a global biotechnology company that discovers,develops and commercializes transformative cancer medicines.With the addition of Seagens pipeline and its four in-line medicines(Padcev,Adcetris,Tukysa and Tivdak),P

130、fizers oncology portfolio spans multiple modalities,including ADCs,small molecules,bispecifics and other immunotherapies.In addition to the acquisition of Seagen,our significant recent business development activities in 2023 include,amongothers,the September 2023 divestiture of our early-stage rare

131、disease gene therapy portfolio to Alexion.For a further discussion of our strategy and our business developmentinitiatives,see the Overview of Our Performance,Operating Environment,Strategy and Outlook section within MD&A and Note 2.COMMERCIAL OPERATIONSIn 2023,we managed our commercial operations t

132、hrough a global structure consisting of two operating segments,each led by a single manager:Biopharma,our innovative science-based biopharmaceutical business,and Business Innovation,an operating segment established in the first quarter of 2023 that includes PC1,our contract development andmanufactur

133、ing organization and a leading supplier of specialty active pharmaceutical ingredients,and Pfizer Ignite,an offering that provides strategic guidance and end-to-end R&Dservices to select innovative biotech companies that align with our R&D focus areas.In 2023,Biopharma was the only reportable segmen

134、t.The commercial structure withinBiopharma included three broad customer groups in 2023:Primary Care,Specialty Care and Oncology.At the beginning of 2024,we made changes in our commercial organization to incorporate Seagen and improve focus,speed and execution.Specifically,within our Biopharmareport

135、able segment we created the Pfizer Oncology Division,the Pfizer U.S.Commercial Division,and the Pfizer International Commercial Division:DivisionDescriptionPfizer Oncology DivisionCombines the U.S.Oncology commercial organizations,global Oncology marketing organizations and global and U.S.Oncology m

136、edical affairs from bothPfizer and Seagen.Includes innovative oncology product portfolio of ADCs,small molecules,bispecifics and other immunotherapies that treat a widerange of cancers including certain types of breast cancer,genitourinary cancer and hematologic malignancies,as well as certain types

137、 of melanoma,gastrointestinal,gynecological and thoracic cancers,which includes lung cancer.Pfizer U.S.CommercialDivisionIncludes the U.S.Primary Care and U.S.Specialty Care customer groups,the Chief Marketing Office,the Global Chief Medical Affairs Office andGlobal Access&Value.U.S.Primary Care inc

138、ludes:Internal medicine product portfolio of brands in cardiovascular metabolic,bone graft for spinal fusion and womens health,as well as post-LOEbrands.Migraine product portfolio.Vaccines product portfolio across all ages with a pipeline focus on infectious diseases with significant unmet medical n

139、eed,including COVID-19.Treatment for COVID-19.Products for detection of COVID-19 and influenza.U.S.Specialty Care includes:Inflammation&immunology product portfolio of brands and biosimilars for chronic immune and inflammatory diseases.Rare disease product portfolio of brands for a number of therape

140、utic areas with rare diseases,including amyloidosis,hemophilia,endocrine diseasesand sickle cell disease.Hospital product portfolio of sterile injectable and immunoglobulin medicines.Pfizer International CommercialDivisionIncludes the ex-U.S.commercial and medical affairs organizations covering Pfiz

141、ers entire product portfolio in all international markets.Select products within Oncology,Primary Care and Specialty Care include:Oncology:Ibrance,Xtandi,Inlyta,Bosulif,Lorbrena,Braftovi,Mektovi,Padcev,Adcetris,Talzenna,Tukysa,Elrexfio and Tivdak Primary Care:Internal medicine:Eliquis,the Premarin f

142、amily and BMP2 Migraine:Nurtec ODT/Vydura and Zavzpret Vaccines:Comirnaty,the Prevnar family,Abrysvo,FSME/IMMUN-TicoVac,Nimenrix and Trumenba Treatment for COVID-19:Paxlovid Detection of COVID-19 and influenza:Lucira by Pfizer Specialty Care:Inflammation&immunology:Xeljanz,Enbrel(outside the U.S.and

143、 Canada),Inflectra,Cibinqo,Litfulo and Velsipity Rare disease:the Vyndaqel family,Genotropin,BeneFIX,Oxbryta,Somavert and Ngenla Hospital:Sulperazon,Zavicefta,Zithromax,Medrol and PanzygaFor additional information on our operating segments and products,including product revenues,see Note 17,and for

144、additional information on the key operational revenue drivers ofour business,see the Analysis of the Consolidated Statements of Income section within MD&A.For a discussion of the risks associated with our dependence on certain of our majorproducts,see the Item 1A.Risk FactorsConcentration section.RE

145、SEARCH AND DEVELOPMENTR&D is at the heart of fulfilling our purpose to deliver breakthroughs that change patients lives as we work to translate advanced science and technologies into the medicines andvaccines that may be the most impactful for patients.In addition to discovering and developing new p

146、roducts,our R&D efforts seek to add value to our existing products byimproving their safety,efficacy and ease of dosing and by discovering potential new indications.Pfizer Inc.2023 Form 10-K4Our R&D Priorities and Strategy.Our R&D priorities include:delivering a pipeline of highly differentiated med

147、icines and vaccines where we have a unique opportunity to bring the most important new therapies to patients in need;advancing our capabilities that can position us for long-term R&D leadership;and advancing new models for partnerships with creativity,flexibility and urgency to deliver innovation to

148、 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,oncology,rare diseases,vaccines,and anti-infectives.While a significant portion of our R&D is internal,we also seek promising chemical and biol

149、ogical lead molecules and innovative technologies developed by others to incorporate intoour discovery and development processes or projects,as well as our portfolio.We do so by entering into collaboration,alliance and license agreements with universities,biotechnology companies and other firms as w

150、ell as through acquisitions and investments.These collaboration,alliance and license agreements and investments allow us to shareknowledge,risk and cost.They also enable us to access external scientific and technological expertise,as well as provide us the opportunity to advance our own products and

151、 in-licensed or acquired products.For information on certain of these collaborations,alliances and license arrangements and investments,see Note 2.Our R&D Operations.In 2023,we continued to strengthen our global R&D operations and pursue strategies to improve R&D productivity to achieve a sustainabl

152、e pipeline that ispositioned to deliver value in the near term and over time.Our R&D activity is conducted through various platform functions that support our global operations.Beginning in July2023,in consideration of planned future investments in oncology,including the December 2023 acquisition of

153、 Seagen,we reorganized our R&D platform operations.Discovery tolate-phase clinical development for oncology is performed by a new end-to-end Oncology Research and Development(ORD)organization and discovery to late-phase clinicaldevelopment for all remaining therapeutic areas is consolidated into the

154、 end-to-end Pfizer Research and Development(PRD)organization.ORD and PRD replace our formerWRDM and GPD organizations,where,prior to July 2023,research units within WRDM were generally responsible for research and early-stage development assets and,prior toJuly 2023,GPD was generally responsible for

155、 the clinical development strategy and operational execution of clinical trials for both early-and late-stage clinical assets in Pfizerspipeline.In 2023,Biopharma received R&D services from ORD,PRD and the predecessor WRDM and GPD organizations.These services included IPR&D projects for newinvestiga

156、tional products and additional indications for in-line products.We manage R&D operations on a total-company basis through our PRD and ORD organizations described above.Specifically,the Portfolio Management Team,currently led by ourChairman and Chief Executive Officer and composed of other senior exe

157、cutives,is accountable for aligning resources across PRD and ORD,and for helping to ensure optimalcapital allocation across the innovative R&D portfolio.We believe that this approach also serves to maximize accountability and flexibility.We do not disaggregate total R&D expense by development phase

158、or by therapeutic area since,as described above,we do not manage all of our R&D operations by developmentphase or by therapeutic area.Further,as we are able to adjust a significant portion of our spending quickly,we believe that any prior-period information about R&D expense bydevelopment phase or b

159、y therapeutic area would not necessarily be representative of future spending.For additional information on our R&D operations,including R&D related costs and expenses,see the Costs and ExpensesResearch and Development Expenses section withinMD&A and Note 17.Our R&D Pipeline.The process of drug and

160、biological product discovery from initiation through development and to potential regulatory approval is lengthy and can take more thanten years.As of January 30,2024,we had the following number of projects in various stages of R&D:Development of a single compound is often pursued as part of multipl

161、e programs.While our product candidates may or may not receive regulatory approval,new candidatesentering clinical development phases are the foundation for future products.Information concerning several of our drug and vaccine candidates in development,as well assupplemental filings for existing pr

162、oducts,is set forth in the Product Developments section within MD&A.The discovery and development of drugs,vaccines and biological productsare time consuming,costly and unpredictable.For information on the risks associated with R&D,see the Item 1A.Risk FactorsResearch and Development section.COLLABO

163、RATION AND CO-PROMOTION AGREEMENTSWe use collaboration and/or co-promotion arrangements to enhance our development,R&D,sales and distribution of certain biopharmaceutical products,which include,amongothers,the following:Comirnaty is an mRNA-based coronavirus vaccine to help prevent COVID-19,which is

164、 being jointly developed and commercialized with BioNTech.Pfizer and BioNTech equallyshare the costs of development for the Comirnaty program.Comirnaty has been granted an approval or an authorization in many countries around the world in populations varyingby country.We also share gross profits equ

165、ally from commercialization of Comirnaty and are working jointly with BioNTech in our respective territories to commercialize thevaccine worldwide(excluding China,Hong Kong,Macau and Taiwan),subject to regulatory authorizations or approvals market by market.For discussion on Comirnaty,see theOvervie

166、w 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 alternative treatment option to warfarin inappropriate patients.We fund between 50%a

167、nd 60%of all development costs depending on the study,and profits and losses are shared equally except in certain countrieswhere we commercialize Eliquis and pay a percentage of net sales to BMS.InPfizer Inc.2023 Form 10-K5certain smaller markets we have full commercialization rights and BMS supplie

168、s 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 andcommercialized in collaboration with Astellas.We s

169、hare equally in the gross profits and losses related to U.S.net sales and also share equally all Xtandi commercialization costsattributable to the U.S.market,subject to certain exceptions.In addition,we share certain development and other collaboration expenses.For international net sales we receive

170、royalties based on a tiered percentage.Orgovyx(relugolix)is an oral gonadotropin-releasing hormone(GnRH)receptor antagonist for the treatment of adult patients with advanced prostate cancer that is beingdeveloped and commercialized with SMPA.The companies are also collaborating on Myfembree(relugoli

171、x 40 mg,estradiol 1.0 mg,and norethindrone acetate 0.5 mg)for heavymenstrual bleeding associated with uterine fibroids in premenopausal women and the management of moderate to severe pain associated with endometriosis in premenopausalwomen.The companies equally share profits and allowable expenses i

172、n the U.S.for Orgovyx,and in the U.S.and Canada for Myfembree.Pfizer does not have rights outside ofthese markets.SMPA remains responsible for regulatory interactions and drug supply and continues to lead clinical development for the relugolix combination tablet.Padcev(enfortumab vedotin-ejfv)is a f

173、irst-in-class ADC that is directed to Nectin-4,a protein located on the surface of cells and highly expressed in bladder cancer,that is beingco-developed and jointly commercialized with Astellas.In the U.S.,Padcev has been approved for use with Keytruda(pembrolizumab)for adult patients with locally

174、advanced ormetastatic urothelial cancer.Other approvals and indications for Padcev vary by market.In the U.S.,the companies jointly promote,and we record net sales and are responsiblefor all U.S.distribution activities for Padcev.The companies each bear the costs of their own sales organizations in

175、the U.S.,and equally share certain other costs associated withcommercializing and any profits realized in the U.S.for Padcev.Outside the U.S.,we have commercialization rights in all countries in North and South America,and Astellas hascommercialization rights in the rest of the world.The agreement b

176、etween us and Astellas provides that the companies will effectively equally share in profits realized in marketsoutside of the U.S.through:(i)a costs-incurred and profit-sharing mechanism based on product sales and costs of commercialization in certain markets and(ii)a royalty-paymentmechanism inten

177、ded to approximate an equal profit share for both parties in the remaining markets.In addition,we have collaboration and/or co-promotion arrangements with respect to certain other biopharmaceutical products,including Adcetris and Tivdak as a result of ouracquisition of Seagen.Revenues associated wit

178、h these arrangements are included in Alliance revenues(except in certain markets where we have direct sales and except for the majority of revenues forComirnaty and Padcev,which are included in Product revenues).In addition,we have collaboration arrangements for the development and commercialization

179、 of certain pipelineproducts that are in development stage,including,among others certain of those described in the Product Developments section within MD&A.For further discussion of collaborationand co-promotion agreements,see the Item 1.BusinessPatents and Other Intellectual Property Rights sectio

180、n,the Item 1A.Risk FactorsCollaborations and Other Relationshipswith Third Parties section and Notes 2 and 17.INTERNATIONAL OPERATIONSOur operations are conducted globally,and we supply our medicines and vaccines to approximately 200 countries and territories.Emerging markets are an important compon

181、ent ofour strategy for global leadership,and our commercial structure recognizes that the demographics and rising economic power of the fastest-growing emerging markets are becomingmore closely aligned with the profile found within developed markets.Urbanization and the rise of the middle class in e

182、merging markets provide potential growth opportunities for ourproducts.Revenues from operations outside the U.S.of$31.4 billion accounted for 54%of Total revenues in 2023.Revenues exceeded$500 million in each of 14,24 and 21 countriesoutside the U.S.in 2023,2022 and 2021,respectively.The decrease in

183、 the number of countries exceeding$500 million in revenues from 2022 to 2023 was primarily driven bydecreases in revenues related to Comirnaty and Paxlovid.As a percentage of Total revenues,our largest country outside the U.S.was Japan in 2023.For a geographic breakdownof Total revenues,see the Tota

184、l Revenues by Geography section within MD&A and Note 17B.Our international operations are subject to risks inherent in carrying on business in other countries.See the Item 1A.Risk FactorsGlobal Operations and Item 1.BusinessGovernment Regulation and Price Constraints sections.SALES AND MARKETINGOur

185、prescription biopharmaceutical products,with the exception of Paxlovid in 2022 and 2023,are sold principally to wholesalers,but we also sell directly to retailers,hospitals,clinics,government agencies and pharmacies.In 2022 and 2023,we principally sold Paxlovid globally to government agencies.Our va

186、ccines in the U.S.are primarily sold directly tothe federal government(including the CDC),wholesalers,individual provider offices,retail pharmacies and integrated delivery systems.Our vaccines outside the U.S.are primarilysold to government and non-government institutions.Certain of these government

187、 contracts may be renegotiated or terminated at the discretion of a government entity.OurPfizer Inc.2023 Form 10-K6contracts with government and supranational organizations for the sales of Comirnaty and Paxlovid,which are binding contracts,represented a significant amount of revenues in2022 and 202

188、3.Sales of Comirnaty and Paxlovid in the U.S.transitioned to commercial channels in the second half of 2023.For information on our October 2023 amendedagreement with the U.S.government regarding Paxlovid,see Note 17C.We also seek to gain access for our products on formularies,which are lists of appr

189、oved medicines available to members of healthcare programs or PBMs.PBMs use variousbenefit designs,such as tiered co-pays for formulary products,to drive utilization of products in preferred formulary positions.We may also work with payors on diseasemanagement programs that help to develop tools and

190、 materials to educate patients and physicians on key disease areas.For information on our significant customers,see Note17C.We promote our products to healthcare providers and patients consistent with applicable laws.Through our marketing organizations,we explain the approved uses,benefits andrisks

191、of our products to healthcare providers and patients;MCOs that provide insurance coverage,such as hospitals,integrated delivery systems,PBMs and health plans;andemployers and government agencies who hire MCOs to provide health benefits to their employees.In the U.S.,we market directly to consumers t

192、hrough direct-to-consumeradvertising 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 wellnes

193、s,important public health issues and our patient assistance programs.As part of our commitment to engaging our customers in a manner they prefer,we take an omnichannel approach,including both virtual and in person interactions,and seegenerally positive customer response to both approaches.PATENTS AN

194、D OTHER INTELLECTUAL PROPERTY RIGHTSPatents.We own or have co-promotion and/or license rights related to a number of patents covering pharmaceutical and other products,their uses,formulations,and productmanufacturing processes.Patents for individual products extend for varying periods according to t

195、he date of patent filing or grant and the legal term of patents in the various countries where patent protectionis obtained.The scope 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 legalremedie

196、s.Patent term extensions(PTE)may be available in some countries to compensate for a loss of patent term due to delay in a products approval due to the regulatoryrequirements,while patent term adjustment may be available in some countries to compensate for administrative delays during prosecution of

197、patents.One of the primaryconsiderations 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 protection of intellectual property rights.S

198、ee the Item 1.BusinessGovernment Regulation and Price Constraints section.In various markets,a period of regulatory exclusivity may be provided for drugs or vaccines upon approval.The scope and term of such exclusivity will vary but,in general,theperiod will run concurrently with the term of any exi

199、sting patent rights associated with the drug at the time of approval.Based on current sales and other factors,and considering the competition with products sold by our competitors,the patent rights we consider most significant in relation to ourbusiness as a whole,together with the year in which the

200、 basic product patent expires,are as follows:Pfizer Inc.2023 Form 10-K7ProductU.S.Basic Product Patent ExpirationYearMajor Europe Basic Product PatentExpiration YearJapan Basic Product Patent ExpirationYearInlyta202520252025Xeljanz202520282025Prevnar 13/Prevenar 1320262029Eliquis202620262026Ibrance2

201、02720282028Xtandi2027Vyndaqel/Vyndamax/Vynmac2024 (2028 pending PTE)20262026/2029Adcetris2024Nurtec ODT/Vydura2030(2034 pending PTE)20352030Braftovi2030(2031 pending PTE)Mektovi2031Talzenna2029(2032 pending PTE)20342029Oxbryta203320372032Lorbrena203320342036Padcev2033Tukysa2031(2034 pending PTE)2031

202、2026Zavzpret2031(2034 pending PTE)20312031Velsipity2029(2034 pending PTE)20292029Prevnar 20/Apexxnar2033(2035 pending PTE)2033(2037 pending SPC)2033Ngenla203520322030Cibinqo2034(2036 pending PTE)20362038Tivdak20332031Litfulo2034(2037 pending PTE)2034(2038 pending SPC)2034(2039 pending PTE)Abrysvo203

203、6(2037 pending PTE)2036Elrexfio2036(2037 pending PTE)20362036Penbraya203820382038COVID-19 ProductsPfizer-BioNTech COVID-19 Vaccine2041Paxlovid204120412041Pfizer-BioNTech COVID-19 Vaccine,Bivalent(Original and Omicron BA.4/BA.5)/Comirnaty Original/Omicron BA.1VaccineXBB.1.5-Adapted Monovalent COVID-1

204、9vaccineUnless otherwise indicated,the years pertain to the basic product patent expiration,including granted PTEs,supplementary protection certificates(SPC)or pediatric exclusivity periods.SPCs areincluded when granted in three out of five major European markets(France,Germany,Italy,Spain and the U

205、.K.).Noted in parentheses is the projected year of expiry of the earliest pending patent termextension in the U.S.or Japan and/or SPC 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 pate

206、nts relating to our products which may or may not protect our product from generic or biosimilar competition after the expiration of the basic patent.Expiry is provided by regulatory exclusivity in this market.The Europe patent that covers the combination of the 13 serotype conjugates of Prevenar 13

207、 was revoked following an opposition and has now been withdrawn.There are other Europe patents andpending applications covering the formulation,various aspects of the manufacturing process,and the combination of serotype conjugates of Prevenar 13 that remain in force.Eliquis was developed and is bei

208、ng commercialized in collaboration with BMS.In the U.S.,we and BMS previously settled certain patent litigations with a number of generic companies permitting theirlaunch of a generic version of Eliquis on April 1,2028(the settled generic companies).We continued to litigate against three(1)(1)(1)(2)

209、(3)(4)(5)(6)(6)(6)(7)(8)(9)(10)(9)(9)(11)(12)(12)(12)(12)(13)(12)(12)(11)(14)(15)(14)(14)(16)(11)(11)(11)(11)(11)(17)(2)(2)(2)(18)(19)(11)(18)(22)(11)(11)(11)(20)(21)(23)(22)(20)(22)(22)(23)(22)(20)(22)(22)(23)(22)(1)(2)(3)(4)Pfizer Inc.2023 Form 10-K8remaining generic companies and following the re

210、solution of the litigation in our favor,the three generic companies are not permitted to launch their products until the 2031 expiration date of theformulation patent.Both the composition of matter patent expiring in November 2026 and the formulation patent expiring in 2031 may be subject to future

211、challenges.While we cannot predict the outcomeof any potential future litigation,there are certain potential alternatives that might occur which could potentially permit generic launch prior to April 1,2028:(i)if the formulation patent is held invalid or notinfringed in future litigation,through app

212、eal,the settled generic companies and any successful future litigant would be permitted to launch on November 21,2026;or(ii)if both patents are held invalid ornot infringed in future litigation,through appeal,the settled generic companies and any successful future litigant could launch products imme

213、diately upon such an adverse decision.Refer to Note 16A1 formore information.On October 31,2023,the U.K.Supreme Court refused BMSs permission to appeal in relation to the judgment having found the apixaban basic product patent and associated SPC invalid.Additionalchallenges are pending in other juri

214、sdictions.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 ofinternational Xtandi net sales.Interim patent term extension requests have been granted ext

215、ending the expiry from December 2023 to December 2024 and Pfizer has filed applications for patent term extension to 2028.Vyndaqel(tafamidis meglumine)basic patent expiry in Japan is August 2026 for treatment of polyneuropathy.Vynmac(tafamidis)was approved in Japan for treatment of cardiomyopathy wi

216、th regulatoryexclusivity expiring in March 2029.Adcetris is being developed and commercialized in collaboration with Takeda.Pfizer has commercialization rights for Adcetris in the U.S.and its territories and in Canada.Takeda has commercializationrights in the rest of the world and pays Pfizer a roya

217、lty based on a percentage of Takedas net sales of Adcetris in its licensed territories,based on annual net sales tiers.There are other U.S.patents covering related ADC uses,technology and manufacturing that remain in force beyond composition of matter expiry.Product not yet approved or authorized in

218、 this market.We have exclusive rights to Braftovi and Mektovi in the U.S.,Canada and certain emerging markets.The Pierre Fabre Group has exclusive rights to commercialize both products in Europe and Ono hasexclusive rights to commercialize both products in Japan.We receive royalties from The Pierre

219、Fabre Group and Ono on sales of Braftovi and Mektovi in a majority of markets outside the U.S.Mektovi U.S.expiry is provided by a method of use patent.Padcev is being commercialized in collaboration with Astellas.Pfizer has co-promotion rights in the U.S.Outside the U.S.,Pfizer has commercialization

220、 rights in all countries in North and South America,and Astellas has commercialization rights in the rest of the world,including Europe,Asia,Australia and Africa.There is a U.S.patent covering related ADC manufacturing that will remain in force beyond the composition of matter expiry.In September 20

221、20,Seagen and Merck began a collaboration to commercialize Tukysa.As of December 31,2023,this collaboration ended and all commercialization rights were returned to Seagen(Pfizer).Ngenla is being developed in collaboration with OPKO.Tivdak is developed and commercialized in collaboration with Genmab.

222、Pfizer and Genmab have co-promotion rights in the U.S.Outside the U.S.,Pfizer has commercialization rights in the rest of theworld except for Japan,where Genmab has commercialization rights,and certain territories where Zai Lab Limited(Zai Lab)has commercialization rights(mainland China,Hong Kong,Ma

223、cau,andTaiwan).Pfizer and Genmab equally share all costs and profits for Tivdak in the U.S.,Europe,China(including the payments from Zai Lab described below)and Japan.In markets outside the U.S.otherthan Europe,China,and Japan,Pfizer will pay Genmab a royalty based on a percentage of aggregate net s

224、ales.Further,pursuant to the agreement with Zai Lab,Pfizer is entitled to receive potentialdevelopment,regulatory and commercial milestone payments,and tiered royalties on net sales of Tivdak in the Zai Lab territories,which will be shared equally with Genmab.Expiry is provided by regulatory exclusi

225、vity in this market.In addition to regulatory exclusivity,there are U.S.patents covering related ADC manufacturing and technology that remain in force beyond theregulatory exclusivity expiry.Product is being commercialized in collaboration with BioNTech.The basic product patent has been granted in t

226、he U.K.and expires in 2041.In the other major markets,a patent application has been filed.If granted,a full term is expected.The basic product patent application has been filed in this market.If granted,a full term is expected in this market.Pfizer does not have co-promotion rights for this product

227、in Germany.For information regarding profit sharing and royalty arrangements for certain of these products,see Item 1.BusinessCollaboration and Co-Promotion Agreements.Loss of Intellectual Property Rights.The loss,expiration or invalidation of intellectual property rights,patent litigation settlemen

228、ts and judgments and the expiration of co-promotionand 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 legalchallenge,we typically lose exclusivity on these products,and generic and

229、biosimilar pharmaceutical manufacturers generally produce identical or highly similar products and sellthem for a lower price.The date at which generic or biosimilar competition commences may be different from the date that the patent or regulatory exclusivity expires.However,when generic or biosimi

230、lar competition does commence,the resulting price competition can substantially decrease our revenues for the impacted products,often in a very shortperiod of time.Also,if one of our product-related patents is found to be invalid by judicial,court or regulatory or administrative proceedings,generic

231、or biosimilar products could beintroduced,resulting in the erosion of sales of our existing products.Additionally,we could be subject to claims that our intellectual property rights infringe third party patents.Certain of our products have experienced patent-based expirations or loss of regulatory e

232、xclusivity in certain markets in the last few years,and we expect certain products to faceincreased generic competition over the next few years.While additional patent expiries will continue,we expect a moderate impact of reduced revenues due to patent expiries from2024 through 2025.We anticipate a

233、more significant impact of reduced revenues from patent expiries in 2026 through 2030 as several of our in-line products experience patent-based expirations.There is no assurance that a particular product will maintain market exclusivity for the full time period that appears in the estimates include

234、d in this Form 10-K orthat we assume when we provide our financial guidance.For additional information on the impact of LOEs on our revenues,see the Overview of Our Performance,OperatingEnvironment,Strategy and OutlookOur 2023 Performance section within MD&A.We continue to vigorously defend our pate

235、nt rights against infringement,and we will continue to support efforts that strengthen worldwide recognition of patent rights while takingnecessary steps to help ensure appropriate patient access.See the Item 1A.Risk FactorsCompetitive Products,Intellectual Property Protection and Third-Party Intell

236、ectualProperty Claims sections and Note 16A1.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 insome countries for as long as the mark is used while in others,for as long as it i

237、s registered.Protecting our trademarks is of material importance to us.(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)Pfizer Inc.2023 Form 10-K9COMPETITIONOur business is conducted in intensely competitive and highly regulated markets.Many of our products face competition in

238、the form of branded or generic drugs or biosimilars thattreat 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 succe

239、ss.We compete with other companies that manufacture and sell products that treat or prevent diseases or indications similar to those treated or prevented by our major products.Thesecompetitors include other worldwide research-based biopharmaceutical companies,smaller research companies with more lim

240、ited therapeutic focus and generic drug and biosimilarmanufacturers.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 andpotential sales of our products in development,as well as product obsol

241、escence.In addition,several of our competitors operate without large R&D expenses and make a regularpractice of challenging our product patents before their expiration.To help address competitive trends we continually emphasize innovation,which is underscored by our multi-billion-dollar investment i

242、n R&D,as well as our business developmenttransactions,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 furtherdemonstrate the value of our products for the conditions they treat or prevent,a

243、s well as investigating potential new applications.We educate patients,physicians,payors and globalhealth authorities on the benefits and risks of our medicines and vaccines,and seek to continually enhance the organizational effectiveness of our biopharmaceutical functions,including our efforts to e

244、ffectively launch and market our products to our 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 improveour organization and business practices in an effort to better mee

245、t customer and public needs.We believe that we have taken an industry-leading role in evolving our ethicalapproaches to U.S.direct-to-consumer advertising,interactions with,and payments to,healthcare professionals and medical education grants.We also continue to supportprograms to address patient af

246、fordability and access barriers,as we strive to advance fundamental health system change through our support for better healthcare solutions.Forexample,in May 2022,we launched An Accord for a Healthier World,which aims to provide our full portfolio of patented and off-patent medicines and vaccines f

247、or which Pfizer holdsglobal rights on a not-for-profit basis to 1.2 billion people living in 45 lower-income countries around the world.Our vaccines have and may continue to face competition,including from the introduction of alternative vaccines or“next-generation”vaccines prior to or after the exp

248、iration of theirpatents,which may adversely affect our future results.Our biosimilars,which include biosimilars of certain inflammation&immunology and oncology biologic medicines,compete with branded products from competitors,as well as othergenerics and biosimilars manufacturers.We seek to maximize

249、 the opportunity to establish a“first-to-market”or early market position 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 Prod

250、ucts.Generic pharmaceutical manufacturers pose one of the biggest competitive challenges to our branded small molecule products because they can market acompeting version of our product after the expiration or loss of our patent protection and often charge much less.Several competitors regularly cha

251、llenge our product patents beforetheir expiration.Generic competitors often operate without large R&D expenses,as well as without costs of conveying medical information about products to the medical community.In addition,the approval process in the U.S.and in the EU exempts generics from costly and

252、time-consuming clinical trials to demonstrate their safety and efficacy,allowing genericmanufacturers to rely on the safety and efficacy data of the innovator product.In China,for example,given the expansion of the QCE process and continuation of the VBP program,we expect to continue to face intensi

253、fied competition by certain generic manufacturers in 2024 and beyond,which has and may continue to result in price cuts and volume loss ofsome of our products.In addition,generic versions of competitors branded products have and may continue to compete with our products.Commercial and government pay

254、ors typically encourage the use of generics as alternatives to brand-name drugs in their healthcare programs,including Medicaid in the U.S.,andU.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 physi

255、cians are able toexpressly prevent such substitution.Similar rules also apply in several EU member states,where national authorities typically encourage and incentivize the use of generic products.Biosimilars.Certain of our biologic products,including Enbrel(we market Enbrel outside the U.S.and Cana

256、da),already face,or may face in thefuture,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 similarto the original biologic in terms of safety and efficacy and that have no clinically

257、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 by the FDA under the U.S.Public HealthService Act,whereas in

258、the EU the EMA is responsible for evaluating the majority of applications for biosimilars through the centralized procedure.PRICING PRESSURES AND MANAGED CARE ORGANIZATIONSCommercial Pricing Pressures.Pricing and access pressures in the commercial sector continue to be significant.Overall,there is i

259、ncreasing pressure on U.S.providers to deliverhealthcare at a lower cost and to ensure that those expenditures deliver demonstrated value in terms of health outcomes.Many employers have adopted or make available highdeductible health plans,which can increase out-of-pocket costs for medicines.This tr

260、end is likely to continue.Private third-party payors,such as health plans,increasingly challengepharmaceutical 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 ofour products,if lower cost

261、alternatives are available.Payors often require significant discounts,or rebates,from our prices in exchange for more favorable formulary placement.Pricing pressures also may occur as a result of highly competitive biopharmaceutical markets and increasing concentration of insurers and PBMs.Healthcar

262、e 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 in focus among payors and their PBMs away from fee-for-service reimbursement towards outcomes-ba

263、sed payments and risk-sharing arrangementsthat reward providers and pharmaceutical manufacturers for cost reductions and improved patient outcomes.These new payment models can,at times,lead to lower prices for,andrestricted access to,new medicines.At the same time,these models can also promote utili

264、zation of drugs by encouraging physicians to screen and diagnose and consider drugs asa means of forestalling more costly medical interventions.Further,these models may also encourage payors and their PBMs to cover higher cost drugs where coverage is tied topatient outcomes and other quality incenti

265、ves.Pfizer Inc.2023 Form 10-K10The impact of large-scale healthcare disruptions,like the COVID-19 pandemic,on the pace of adoption of value-based payment models remains unclear.Both payors and providersmay resist adopting such models or choose to adopt such models at a slower pace if the incentives

266、available do not outweigh the financial risk involved.Adoption of such models,inparticular models that involve downside risk,may depend on revenue predictability for hospitals and other institutional providers,many of which are still struggling to recoverfinancially following the COVID-19 pandemic.P

267、roviders in more advanced value-based payment models,such as full capitation,a fixed amount paid in advance per-patient per-unitof time-period,generally found their revenues remained steady during the COVID-19 pandemic,which may ultimately encourage the growth of such models.Going forward,weexpect c

268、ontinued focus on value-based payment models that support financial resiliency and advance healthcare equity by incorporating features intended to reduce disparities inhealthcare quality and access experienced by underrepresented and underserved populations.We believe medicines and vaccines are the

269、most efficient and effective use of healthcare dollars based on the value they deliver to the overall healthcare system.We work with lawmakers and advocate for solutions that effectively improve patient health outcomes,lower costs to the healthcare system,and help ensure access to medicines and vacc

270、ines withinan efficient and affordable healthcare system.This includes assessing our go-to market model to help address patient affordability challenges.We have engaged with major payorsand the U.S.government to explore opportunities to improve access and reimbursement in an effort to drive pro-pati

271、ent policies.In addition,in response to the evolving U.S.andglobal healthcare spending landscape,we work with health authorities,health technology assessment and quality measurement bodies and major U.S.payors throughout theproduct-development process to better understand how these entities value ou

272、r compounds and products.Further,we are developing stronger support designed to demonstrate thenet value of the medicines and vaccines that we discover or develop,register and manufacture.For information on government pricing pressures,see the Item 1.BusinessGovernment Regulation and Price Constrain

273、ts and Item 1A.Risk FactorsPricing and Reimbursementsections.Managed Care Organizations.The evolution of managed care in the U.S.has been a major factor in the competitiveness of the healthcare marketplace.Approximately 318 millionpeople in the U.S.now have some form of health insurance coverage,and

274、 the marketing of prescription drugs and vaccines to both consumers and the entities that managecoverage in the U.S.continues to grow in importance.In particular,the influence of MCOs has increased in recent years due to the growing number of patients receiving coveragethrough MCOs.At the same time,

275、consolidation in the MCO industry has resulted in fewer,even larger MCOs,which enhances those MCOs ability to negotiate lower pricing andfurther increases their importance to our business.Since MCOs seek to contain and reduce healthcare expenditures,their growing influence has increased downward pre

276、ssure ondrug prices,as well as negatively impacted revenues.MCOs and their PBMs typically negotiate prices with pharmaceutical providers by using formularies(which are lists of approved medicines available to MCO members),clinicalprotocols(which require prior authorization for a branded product if a

277、 generic product is available or require the patient to first fail on one or more generic products before permittingaccess to a branded medicine),long-term contracts and their ability to influence volume and market share of prescription drugs.In addition,by placing branded medicines on higher-tier o

278、r non-preferred status in their formularies,MCOs transfer to the patient higher patient out-of-pocket expenses.This financial disincentive is a tool for MCOs to manage drugcosts and channel patients to medicines preferred by the MCOs.We expect payment reforms for MCOs will continue to evolve with in

279、creased emphasis on expanded participationand on removing barriers to equitable healthcare.The breadth of the products covered by formularies can vary considerably from one MCO to another,and many formularies include alternative and competitive products fortreatment of particular medical problems.MC

280、Os emphasize primary and preventive care,out-patient treatment and procedures performed at doctors offices and clinics as ways tomanage costs.Hospitalization and surgery,typically the most expensive forms of treatment,are carefully managed,and drugs that can help in chronic care management and reduc

281、ethe need for hospitalization,professional therapy or surgery may become favored first-line treatments for certain diseases.At the same time,MCOs may seek to exclude high-costdrugs from formularies in their efforts to manage and lower their costs.Exclusion of a product from a formulary or other MCO-

282、implemented restrictions can significantly impact drug usage in the MCO patient population and beyond.Consequently,pharmaceutical 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 ofuse,or

283、 fewer side effects,as well as the overall cost of the therapy.We continue to seek to ensure that our major products are included on MCO formularies.However,our brandedproducts are increasingly being placed on the higher tiers or in a non-preferred status.Continuing efforts by managed care entities

284、to contain or reduce costs of healthcare and/orimpose price controls may adversely affect demand for our products and our financial performance.See the Item 1A.Risk FactorsManaged Care Trends section.RAW MATERIALSWe procure raw materials essential to our business from numerous suppliers worldwide.In

285、 general,these materials have been available in sufficient quantities to support ourdemand 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 2024.However,we continue to see heightened d

286、emand in the industry for certain components and raw materials,which could potentially result in constraining available supply leading to apossible future impact on our business.We are continuing to monitor and implement mitigation strategies to reduce any potential risk or impact including active s

287、uppliermanagement,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 countries in which we do business.This includes laws and regulations governing the

288、 operations ofbiopharmaceutical companies,such as the approval,manufacturing and marketing of products,pricing(including discounts and rebates)and price reporting,interactions withhealthcare professionals,institutions,and referral sources,reporting of remuneration provided to healthcare providers an

289、d academic medical centers,financial assistance providedto patients,clinical research,data privacy and information security,among others.These laws and regulations may require administrative guidance for implementation,and a failureto comply could subject us to legal and/or administrative actions.En

290、forcement measures may include substantial fines and/or penalties,orders to stop non-compliant activities,criminal charges,warning letters,product recalls or seizures,delays in product approvals,exclusion from participation in government programs or contracts as well as limitations onconducting busi

291、ness in applicable jurisdictions,and could result in harm to our reputation and business.See Note 16A.Compliance with these laws and regulations may be costly,and may require significant technical expertise and capital investment to ensure compliance.While capital expenditures or operating costs for

292、 compliance with governmentregulationsPfizer Inc.2023 Form 10-K11cannot be predicted with certainty,we do not currently anticipate they will have a material effect on our capital expenditures or competitive position.In the U.S.Drug and Biologic Regulation.The FDA,pursuant to the FFDCA,the Public Hea

293、lth Service Act and other federal statutes and regulations,extensively regulates pre-and post-marketing activities related to our biopharmaceutical products and devices.The regulations govern areas such as safety and efficacy,clinical trials,advertising and promotion,qualitycontrol,manufacturing,lab

294、eling,distribution,post-marketing safety surveillance and reporting,and record keeping.Other U.S.federal agencies,including the DEA,also regulatecertain of our products and activities.For a biopharmaceutical company to market a drug or a biologic product,including vaccines,the FDA must evaluate whet

295、her the product is safe and effective for its intended use.Ifthe FDA determines that the drug or biologic is safe and effective,the FDA will 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 ar

296、e studies or clinical trials that the product sponsor agrees to conduct,or postmarketing requirements,which are studies or clinical trials that are required as a condition of approval.In addition,we are also required to report adverse events and comply with cGMPs(the FDAregulations that govern all a

297、spects of manufacturing quality for pharmaceuticals)and the Drug Supply Chain Security Act(the law that,among other things,sets forth requirementsrelated to product tracing,product identifiers and verification for manufacturers,wholesale distributors,re-packagers and dispensers to facilitate the tra

298、cing of product through thepharmaceutical distribution supply chain),as well as advertising and promotion regulations.See the Item 1A.Risk FactorsDevelopment,Regulatory Approval and Marketing ofProducts and Post-Authorization/Approval Data sections.In the context of public health emergencies,like th

299、e COVID-19 pandemic,we may apply to the FDA for an EUA which,if granted,allows for the distribution and use of our productsduring 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 fromt

300、he criteria for approval of an NDA or BLA,EUAs nevertheless require the development and submission of data to satisfy the relevant FDA standards,and a number of ongoingobligations.The FDA generally expects EUA holders to work toward submission of full applications,such as a BLA or an NDA,as soon as

301、possible.Biosimilar Regulation.The FDA is responsible for approval of biosimilars.Innovator biologics,or reference products,are entitled to 12 years exclusivity.Applications for biosimilarsmay not be submitted until four years after the date on which the reference product was first licensed and may

302、not be approved until 12 years after the reference product was firstlicensed.Sales and Marketing Regulations.Our marketing practices are subject to federal and state laws,such as the Anti-Kickback Statute(AKS),Civil Monetary Penalties Law and FalseClaims Act,intended to prevent fraud and abuse in th

303、e healthcare industry.The AKS prohibits soliciting,offering,receiving,or paying anything of value to generate business that maybe paid for,in whole or in part,by a federal healthcare program.The Civil Monetary Penalties Law covers a variety of conduct,often violations under other laws,and includespe

304、nalties for AKS violations as well as causing the submission of false claims.The False Claims Act generally prohibits anyone from knowingly and willingly presenting,or causing tobe presented,any claims for payment for goods or services,including to government payors,such as Medicare and Medicaid,tha

305、t are false or fraudulent including false certificationsof compliance with applicable law.The federal government and states also regulate sales and marketing activities and financial interactions between manufacturers and healthcareproviders,requiring disclosure to government authorities and the pub

306、lic of such interactions,and the adoption of compliance standards or programs.State attorneys general havealso taken action to regulate the marketing of prescription drugs under state consumer protection and false advertising laws.Pricing,Reimbursement and Access Regulations.Pricing and reimbursemen

307、t for our products depend in part on government regulation.Any significant efforts at the federal or statelevels to reform the healthcare system by changing the way healthcare is provided or funded or to expand controls on drug pricing,government reimbursement,and access tomedicines and vaccines on

308、public and private insurance plans could have a material impact on us.We must offer discounts or rebates on purchases of pharmaceutical products under various government programs including Medicare,Medicaid,the Veterans Administration and the340B Drug Pricing Program(340B Program).We also must repor

309、t specific prices to government agencies.The calculations necessary to determine the prices reported are complexand the failure to do so accurately may expose us to enforcement measures.See the discussion regarding rebates in the Product Revenue Deductions section within MD&A andNote 1G.The drug pri

310、cing provisions of the IRA,which was signed into law in August 2022,began to be implemented in 2022 and implementation will continue over the next several years.The IRA includes several provisions to lower prescription drug costs for Medicare patients and to reduce drug spending by the federal gover

311、nment.Among other things,the IRAenhances the Medicare Part D benefit by eliminating the coverage gap(“donut hole”)beginning in 2025,adds a maximum out-of-pocket cap for Medicare beneficiaries(set at$2,000for 2025),and creates a new program that allows patients to pay their cost-sharing over time.The

312、 law also requires manufacturers to provide a 10%discount on brandedprescriptions in the initial coverage phase and a 20%discount in the catastrophic phase,imposes rebates under Medicare Part B and Medicare Part D on drug price increases thatoutpace inflation,and directs HHS to set the prices of cer

313、tain high-expenditure,single-source drugs and biologics covered under Medicare(known as the“Medicare Drug PriceNegotiation Program”).In August 2023,the Biden Administration published the first ten medicines subject to the Medicare Drug Price Negotiation Program,which included Eliquis.As a selected d

314、rug,CMS will establish a“maximum fair price”for Eliquis and that price will be published by September 1,2024.The price will be in effect in 2026.The maximum fairprice established by CMS is required to be offered to all Medicare beneficiaries and to covered entities participating in the 340B Program

315、if that maximum fair price is lower than thediscounted price such entities are offered under the 340B Program ceiling price calculation.In addition,there will be a new Medicare manufacturer discount program agreementexpected to be signed in March 2024 that will change our discounting obligations for

316、 all medicines in Medicare,with few exceptions,beginning in 2025.The Medicare Drug PriceNegotiation Program is currently subject to legal challenges and therefore,the outcome of the Program remains uncertain.We continue to evaluate the impact of the IRA on ourbusiness,operations and financial condit

317、ion and results as the full effect of the IRA on our business and the pharmaceutical industry remains uncertain.Changes to the Medicaid Drug Rebate Program or the 340B Program could have a material impact on our business.For example,certain changes finalized by CMS in a December2020 final rule,inclu

318、ding which products qualify as so-called“line extension”drugs subject to increased rebate liability,may have a material impact on our business.Additionally,inMay 2023,CMS proposed new rules that could,if finalized,have a material impact on our business.Those proposals include,for example,new rules r

319、egarding how manufacturerswould be required to aggregate discounts for purposes of determining their Medicaid Best Price.Additionally,various potential changes to the 340B Program are undergoingPfizer Inc.2023 Form 10-K12review or are the subject of current regulatory activity and/or litigation,and

320、their status is unclear.In 2022,we implemented a policy that will help improve contract pharmacy integrity.The HHS Health Resources and Services Administration(HRSA),which administers the 340B Program,has sent letters to numerous manufacturers that have also implementedcontract pharmacy policies and

321、 integrity initiatives;the letters express HRSAs view that those manufacturers policies are in violation of the 340B statute.HRSA also has referredsome of those other manufacturers to the HHS Office of Inspector General(OIG)for potential enforcement action.Pfizer has not received an enforcement lett

322、er from HRSA to daterelating to our 340B Program integrity initiative.Several manufacturers have challenged HRSAs enforcement letters in federal court and litigation is ongoing in those cases.Webelieve that our policy is consistent with the statute.In addition,some states have enacted laws seeking t

323、o restrict manufacturer policies related to contract pharmacy transactions intheir states.At least one state has begun to pursue enforcement proceedings under its law.Several stakeholders have challenged such laws in certain states.Other states haveconsidered and could enact similar laws going forwa

324、rd,although any such laws also may be subject to legal challenges.Additional legal or legislative developments at the federal orstate 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 suchdevel

325、opments.The 340B Program continues to be a subject of regulatory activity,congressional scrutiny and inquiries,litigation,and other developments,any or all of which couldaffect the scope of the program and Pfizers obligation to offer discounts to 340B Program covered entities under the program.See t

326、he Item 1A.Risk FactorsPricing andReimbursement section.States seek to control healthcare costs related to Medicaid and other state regulated healthcare programs.A majority of states use preferred drug lists to manage access topharmaceutical products under Medicaid,including some of our products.Sta

327、tes may seek to negotiate supplemental rebate agreements that are larger than the minimum federalrequirement for preferred formulary access.Preferred access to our products under the Medicaid managed care programs are often determined by the managed care health planscontracted by the state to admini

328、ster benefits,which may also require supplemental rebates for preferred formulary access.We expect states will continue to seek cost cutting,whichmay focus on managed care capitation payments,supplemental rebates,and/or formulary management.We expect to see continued focus by Congress and the Biden

329、Administration on regulating pricing and access to medicine,in addition to actions already taken,which could result inlegislative and regulatory changes.Government and private payors routinely seek to manage utilization and control the costs of our products.There is considerable public andgovernment

330、 scrutiny of pharmaceutical pricing and actions being taken at the state and federal level.Further efforts by states and the federal government to regulate prices orpayment for pharmaceutical products,including proposed actions to facilitate drug importation,such as Floridas drug importation program

331、 which was recently authorized by theFDA,limit reimbursement to lower reference prices,require deep discounts,impose financial penalties related to pricing practices,and require manufacturers to report and makepublic price increases and sometimes a written justification for the increase,could advers

332、ely affect our business if implemented.Further,commercial payors often follow Medicarecoverage and reimbursement policies when setting their own payment rates.Any reduction in cost or other containment measures may similarly be adopted by commercial plans.Payors may continue to promote generic drugs

333、 and biosimilars more aggressively to generate savings and attempt to stimulate additional price competition.In addition,we expectthat consolidation and integration among pharmacy chains,wholesalers and PBMs will increase pricing pressures in the industry.See the Item 1A.Risk FactorsManaged CareTrends section.Anti-Corruption.The FCPA prohibits U.S.corporations and their representatives from offeri