輝瑞 Investor-Overview-at-2025-JPM-vFINAL.pdf

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1、1Pfizer Investor OverviewAt 2025 J.P.Morgan Healthcare ConferenceJanuary 20252These materials will include forward-looking statements that are subject to substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements.We inc

2、lude forward-looking statements about,among other topics,our anticipated operating and financial performance,including financial guidance and projections;changes to Pfizers commercial organization;reorganizations;business plans,strategy,goals and prospects;expectations for our product pipeline,in-li

3、ne 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 pricing and reimbursement,potential market dynamics,including demand,market s

4、ize and utilization rates and growth,performance,timing of exclusivity and potential benefits;strategic reviews;capital allocation objectives;an enterprise-wide cost realignment program(including anticipated costs,savings and potential benefits);a manufacturing optimization program to reduce our cos

5、t of goods sold(including anticipated costs,savings and potential benefits);dividends and share repurchases;plans for and prospects of our acquisitions,dispositions and other business development activities,including our December 2023 acquisition of Seagen,and our ability to successfully capitalize

6、on growth opportunities and prospects;manufacturing and product supply;our ongoing efforts to respond to COVID-19,including our plans and expectations regarding our COVID-19 products and our expectations regarding the impact of COVID-19 on our business,operations and financial results;and other stat

7、ements about our business,operations and financial results.Among other things,statements regarding revenue and earnings per share growth;anticipated operating and financial performance;the development or commercial potential of our product pipeline,in-line products,product candidates and additional

8、indications or combinations,including expected clinical trial protocols,the timing and potential for the initiation and progress of clinical trials and data read-outs from trials;the timing and potential for the submission of applications for and receipt of regulatory approvals;the timing and potent

9、ial for product launches and commercialization;expected profile and labeling;potential revenue;anticipated COVID-19 vaccination rates and Paxlovid treatment courses sold;expected breakthrough,best or first-in-class or blockbuster status or expected market entry of our medicines or vaccines;the regul

10、atory landscape;and the competitive landscape are forward-looking and are estimates that are subject to change and subject to,among other risks,assumptions and uncertainties,clinical trial,regulatory and commercial success,demand,availability of supply,excess inventory write-offs,product recalls,wit

11、hdrawals and competitive and market dynamics.These statements may be affected by underlying assumptions that may prove inaccurate or incomplete,and are subject to risks,uncertainties and other factors that may cause actual results to differ materially from past results,future plans and projected fut

12、ure results.Additional information regarding these and other factors can be found in Pfizers Annual Report on Form 10-K for the fiscal year ended December 31,2023 and its subsequent reports on Form 10-Q,including in the sections thereof captioned“Risk Factors”and“Forward-Looking Information and Fact

13、ors That May Affect Future Results”,as well as in subsequent reports on Form 8-K,all of which are filed with the U.S.Securities and Exchange Commission and available at www.sec.gov and .Potential risks and uncertainties also include global economic and/or geopolitical instability,foreign exchange ra

14、te fluctuations and inflationary pressures and the uncertainties regarding the impact of COVID-19.The forward-looking statements in this presentation speak only as of the original date of this presentation and we undertake no obligation to update or revise any of these statements.These materials wil

15、l include certain financial measures that were not prepared in accordance with U.S.generally accepted accounting principles(GAAP).Additional information regarding non-U.S.GAAP financial measures can be found on slide 11;in our press release dated December 17,2024;and the“Non-GAAP Financial Measure:A

16、djusted Income”section of Managements Discussion and Analysis of Financial Condition and Results of Operations in Pfizers 2023 Annual Report on Form 10-K.Any non-U.S.GAAP financial measures presented are not,and should not be viewed as,substitutes for financial measures required by U.S.GAAP,have no

17、standardized meaning prescribed by U.S.GAAP and may not be comparable to the calculation of similar measures of other companies.Todays discussions and these materials are intended for the investor community only;they are not intended to promote the products referenced herein or otherwise influence h

18、ealthcare prescribing decisions.Definitive conclusions cannot be drawn from cross-trial comparisons or anticipated data as they may be confounded by various factors and should be interpreted with caution.All trademarks in this presentation are the property of their respective owners.Certain of the p

19、roducts and product candidates discussed in these materials are being co-researched,co-developed and/or co-promoted in collaboration with other companies for which Pfizers rights vary by market or are the subject of agreements pursuant to which Pfizer has commercialization rights in certain markets.

20、Forward-Looking Statements and Non-GAAP Financial Information3 Improve R&D productivity with sharpened focus Expand margins and maximize operational efficiency Achieve commercial excellence in our key categories Optimize capital allocation2025Key Priorities:Enhancing Shareholder Value41.See slide 11

21、 for definitions,including with respect to non-GAAP financial measures,and additional information regarding Pfizers 2025 financial guidance as of December 17,2024.2025 Financial Guidance1Reported Revenues$61.0 to$64.0 BillionAdjusted1SI&A Expenses$13.3 to$14.3 BillionAdjusted1R&D Expenses$10.7 to$11

22、.7 BillionEffective Tax Rate on Adjusted1Income15.0%Adjusted1Diluted EPS$2.80 to$3.0052025 IRA Part D Redesign Items Impacting Our Business$2,000 annual out-of-pocket cap and new Prescription Payment Plan Sunsetting of the Coverage Gap Discount Program and addition of new manufacturer discounts in t

23、he initial and catastrophic coverage phasesTotal Expected Net Impact of IRA Part D RedesignInflation Reduction Act(IRA)Impact in 20251.Calculation performed on 2024 Revenue at the midpoint of our 2024 baseline Revenue guidance range,which excludes$1.2B in non-recurring 2024 Paxlovid revenues.These I

24、tems are Expected to Have a$1 Billion,or 1.6%1,Net Unfavorable YoY Impact on Topline Revenue 6COVID-19Comirnaty*:Materially stable vaccination rates and market share in U.S.and revenue phasing similar to 2024,primarily concentrated in the back-half of the year with the distribution between Q3 and Q4

25、 dependent on the timing of strain selection and approvals by regulatory agencies.Advance purchase agreements remain in place outside the U.S.Paxlovid:Utilization to follow infection rates and stable market share;revenues may fluctuate based on the timing,duration and severity of COVID cases.Certain

26、 Medicaid and Medicare patients to transition out of PAP in first quarter of 2025 with associated additional revenues recognized on a cash-basis.VaccinesAbrysvo*:International market expansion in both adult and maternal indications.Competition and a narrowing opportunity in the U.S.given current Adv

27、isory Committee on Immunization Practices(ACIP)recommendations.Prevnar*:Pediatric market(2/3 of overall PCV revenues)largely consistent with stable market share expected through end of the decade.Expected competition in PCV Adult(1/3 of overall PCV revenues);limited additional catch-up opportunity i

28、n the 65+population in the U.S.;partially offset by expanded opportunity in ages 50-64 in U.S.International market growth from continued PCV20 Adult and Pediatric indication roll-out.OncologySeagen impact:Overall growth rate mathematically dampened due to overlapping of Seagen acquisition.Padcev:ben

29、efit from continued uptake in 1L la/mUC.Lorbrena:expected to continue to benefit from share expansion into 1L treatment and long duration of therapyIbrance:competitive pressures across markets as well as generic entry in select markets.Elrexfio:U.S.-Continued growth due to anticipated increase in ov

30、erall share and new patient starts within the BCMA BsAb class;International-Continued growth driven by significant and rapid demand in Japan and other countries where Elrexfio was first-to-market or launched simultaneously with competition,as well over 20 additional anticipated approvals and/or comm

31、ercially-reimbursed launches.Specialty CareVyndaqel:Unfavorable impact of Inflation Reduction Act(IRA)Part D Redesign in 2025 and new competition in the U.S.International-continued expansion benefiting from increases in diagnosis and treatment rates.Primary CareEliquis:Continued growth through marke

32、t and share expansion.Nurtec:Continued benefit from commercial execution,Health Care Provider and patient engagement and education,and,to lesser extent,uptake in International markets.2025 Key Product Assumptions and Considerations*Assumption for entire vaccines portfolio is that there will be no ma

33、terial U.S.policy changes in 2025.BCMA=B-cell maturation antigen;BsAB=bispecific antibody;PAP=Patient Assistance Program;PCV=pneumococcal conjugate vaccine;1L=first line;la/mUC=locally advanced/metastatic urothelial cancer7*Study sponsored by Merck;potential based on interim analysis|*Emerging data

34、from ongoing studies will inform additional Phase 3 starts in 1L NSCLCNote:Some pivotal program starts may be subject to generation of positive data in earlier-stage studies and/or alignment with regulatory agenciesNote:Many Phase 3 studies are event-driven and readouts are therefore subject to chan

35、geCo-development partners:Adcetris(Takeda),Padcev(Merck and Astellas),vepdegestrant(Arvinas),Xtandi(Astellas)ADC=Antibody drug conjugate;BC=breast cancer;BRAFm=BRAF-mutant;C.difficile=Clostridioides difficile;CSPC=castration-sensitive prostate cancer;DCE=double-class exposed;ER+=estrogen-receptor po

36、sitive;HER2+=human epidermal growth factor receptor 2 positive;LBCL=Large B-cell lymphoma;mBC=metastatic breast cancer;mCRC=metastatic colorectal cancer;mCRPC=metastatic castration-resistant prostate cancer;mCSPC=metastatic castration-sensitive prostate cancer;mHNSCC=metastatic head and neck squamou

37、s cell carcinoma;MIBC=muscle-invasive bladder cancer;NMIBC=non-muscle invasive bladder cancer;NSCLC=non-small-cell lung cancer;PCV=pneumococcal conjugate vaccine;PD-1=programmed cell death protein-1;PD-L1=programmed death ligand-1;PD-L1-high=50%of tumor cells expressing PD-L1;RSV=respiratory syncyti

38、al virus;subq=subcutaneousAnticipated Regulatory DecisionsCompoundIndicationABRYSVO(EU)RSV Infection(18-59 Years)ADCETRISDLBCLBRAFTOVI1L BRAFm mCRC(PFS)TALZENNA+XTANDImCRPC all-comersAnticipated Phase 3 ReadoutsCompoundIndicationBRAFTOVI(BREAKWATER PFS)1L BRAFm mCRCELREXFIODCE Multiple MyelomaHYMPAV

39、ZIHemophilia A or B with InhibitorsInclacumabSickle Cell DiseasePADCEV*MIBCSasanlimab(subq PD-1)NMIBCTALZENNA+XTANDI1L CSPCTUKYSAHER2+BCVepdegestrant2L ER+mBCPotential Pivotal Program StartsCompoundIndication1H 2025Atirmociclib(CDK4i)1L mBCMevrometostat+XTANDI(MEVPRO-3)1L mCSPCSigvotatug vedotin(SV)

40、*1L PD-L1-High NSCLC2H 2025C.difficile Vaccine-Updated FormulationC.difficile InfectionDanuglipronChronic Weight ManagementKAT6i2L mBCNURTECMenstrual MigrainePCV 25-valentPneumococcal Infection(Adult)PDL1V ADC1L mHNSCC PDL1V ADC2L+NSCLCPonsegromabCancer CachexiaVepdegestrant+Atirmociclib1L mBCVepdeg

41、estrant+CDK4/6i2L+mBCSelect 2025 Pipeline Catalysts82025 plans include continued focus on commercial execution,R&D innovation and pipeline progression,and operating margin expansion to drive shareholder value through 2030 and beyond Confident we will deliver on 2025 financial guidance Intense pipeli

42、ne focus to deliver improved R&D productivity Modest margin improvement in 2025 Strong defense of core products,improvement of market share in key categories Maintain growing dividend,meet de-levering target of 3.25x by the end of 2025 and make targeted reinvestment in our businessKey Takeaways9Comp

43、ound NameMechanism of ActionTarget IndicationPhase of DevelopmentSubmission TypeADCETRIS(brentuximabvedotin)CD30-directed antibody-drug conjugateDiffuse Large B-Cell Lymphoma(DLBCL)(Biologic)RegistrationProduct EnhancementTALZENNA(talazoparib)PARP inhibitorCombo w/XTANDI(enzalutamide)for Metastatic

44、Castration Resistance Prostate Cancer(TALAPRO-2)Potential Label Expansion to All-ComersRegistrationProduct EnhancementABRYSVOProphylactic vaccine protein subunitRespiratory Syncytial Virus Infection(18-59 Years)RegistrationProduct EnhancementBRAFTOVI(encorafenib)+ERBITUX(cetuximab)+chemotherapyBRAF

45、kinase inhibitor1L BRAF-Mutant Metastatic Colorectal Cancer(BREAKWATER)RegistrationProduct EnhancementELREXFIO(elranatamab-bcmm)BCMA-CD3 bispecific antibodyMultiple Myeloma Double-Class Exposed(MM-5)(Biologic)Phase 3Product EnhancementHYMPAVZI(marstacimab-hncq)Anti-tissue factor pathway inhibitorHem

46、ophilia A or B with inhibitorsPhase 3Product EnhancementPADCEV(enfortumab vedotin)Nectin-4 directed antibody-drug conjugate Cisplatin-Ineligible/Decline Muscle-Invasive Bladder Cancer(EV-303)(Biologic)*Phase 3Product EnhancementPADCEV(enfortumab vedotin)Nectin-4 directed antibody-drug conjugate Cisp

47、latin-Eligible Muscle-Invasive Bladder Cancer(EV-304)(Biologic)*Phase 3Product Enhancementinclacumab(PF-07940370)Anti-P-selectinSickle Cell Disease(Biologic)(RPD,ORPHAN U.S.)Phase 3New Molecular Entitysasanlimab(PF-06801591)+Bacillus Calmette-Guerin(BCG)Anti-PD-1Non-Muscle-Invasive Bladder Cancer(CR

48、EST)(Biologic)Phase 3New Molecular Entitysigvotatug vedotin(PF-08046047)Integrin beta-6-directed antibody-drug conjugate2L+Metastatic Non-Small Cell Lung Cancer(mNSCLC)(Be6A LUNG-01)(Biologic)Phase 3New Molecular EntityTALZENNA(talazoparib)PARP inhibitorCombo w/XTANDI(enzalutamide)for DNA Damage Rep

49、air(DDR)-Deficient Metastatic Castration Sensitive Prostate Cancer(TALAPRO-3)Phase 3Product EnhancementTUKYSA(tucatinib)HER2 tyrosine kinase inhibitor1L HER2+Maintenance Metastatic Breast Cancer(HER2CLIMB-05)Phase 3Product Enhancementvepdegestrant(ARV-471)ER-targeting PROTACprotein degraderER+/HER2-

50、Metastatic Breast Cancer*(VERITAC 2)(FAST TRACK U.S.)Phase 3New Molecular EntityMevrometostat(PF-06821497)+XTANDI(enzalutamide)EZH2 inhibitor+androgen receptor inhibitorProstate CancerPhase 3New Molecular EntityGlossary:Select Pipeline Assets(1 of 2)Pfizer and Takeda have a collaboration agreement t

51、o co-develop ADCETRIS.Takeda has ex-US/Canada rights*Pfizer and Astellas have a collaboration agreement to co-develop PADCEV*Pfizer and Arvinas have a collaboration agreement to co-develop vepdegestrantRPD:Rare Pediatric Disease designation10Compound NameMechanism of ActionTarget IndicationPhase of

52、DevelopmentSubmission TypePF-07831694Prophylactic vaccine protein subunitClostridioides difficile(C.difficile)updated formulationPhase 2New Molecular EntityPF-07872412Prophylactic vaccine polysaccharide conjugatePneumococcal Infection(FAST TRACK U.S.)Phase 2New Molecular Entityponsegromab(PF-0694686

53、0)Growth Differentiation Factor 15(GDF15)monoclonal antibodyCachexia in Cancer(Biologic)Phase 2New Molecular Entityatirmociclib(PF-07220060)CDK4 inhibitor1L Metastatic Breast CancerPhase 1New Molecular Entitydanuglipron(PF-06882961)Glucagon-like peptide 1 receptor(GLP-1R)agonistChronic Weight Manage

54、mentPhase 1New Molecular EntityPF-07248144KAT6 epigenetic modifierBreast Cancer MetastaticPhase 1New Molecular EntityPF-08046054(PDL1V)PD-L1-directed antibody-drugconjugateAdvanced Solid Tumors(Biologic)Phase 1New Molecular Entityvepdegestrant(ARV-471)+atirmociclib(PF-07220060)ER-targeting PROTAC pr

55、otein degrader+CDK4 inhibitorER+/HER2-1L Metastatic Breast Cancer*Phase 1New Molecular EntityGlossary:Select Pipeline Assets(2 of 2)*Pfizer and Arvinas have a collaboration agreement to co-develop vepdegestrant.11Footnotes(1)Pfizer does not provide guidance for U.S.generally accepted accounting prin

56、ciples(GAAP)Reported financial measures(other than revenues)or a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP Reported financial measures on a forward-looking basis because it is unable to predict with reasonable certainty the ultimate outcome of

57、 unusual gains and losses,certain acquisition-related expenses,gains and losses from equity securities,actuarial gains and losses from pension and postretirement plan remeasurements,potential future asset impairments and pending litigation without unreasonable effort.These items are uncertain,depend

58、 on various factors,and could have a material impact on U.S.GAAP Reported results for the guidance period.Financial guidance for full-year 2025 reflects the following:Does not assume the completion of any business development transactions not completed as of December 16,2024.Reflects an anticipated

59、negative revenue impact of approximately$0.6 billion due to recent and expected generic and biosimilar competition for certain products that have recently lost patent or regulatory protection or that are anticipated to lose patent or regulatory protection.Exchange rates assumed are actual rates at m

60、id-November 2024.Guidance for Adjusted(2)diluted EPS assumes diluted weighted-average shares outstanding of approximately 5.74 billion shares,and assumes no share repurchases in 2025.Our reaffirmed financial guidance as of December 17,2024,for full-year 2024 reflects assumptions that are consistent

61、with those outlined in Note(1)within Pfizers Q3-24Earnings Release.(2)Adjusted income and Adjusted diluted earnings per share(EPS)are defined as U.S.GAAP net income attributable to Pfizer Imon shareholders and U.S.GAAP diluted EPS attributable to Pfizer Imon shareholders before the impact of amortiz

62、ation of intangible assets,certain acquisition-related items,discontinued operations,and certain significant items.Adjusted income and its components and Adjusted diluted EPS measures are not,and should not be viewed as,substitutes for U.S.GAAP net income and its components and diluted EPS(6),have n

63、o standardized meaning prescribed by U.S.GAAP and may not be comparable to the calculation of similar measures of other companies.See the Non-GAAP Financial Measure:Adjusted Income section of Managements Discussion and Analysis of Financial Condition and Results of Operations in Pfizers 2023 Annual

64、Report on Form 10-K for a definition of each component of Adjusted income as well as other relevant information.(3)References to operational variances in this presentation pertain to period-over-period changes that exclude the impact of foreign exchange rates.Although exchange rate changes are part

65、of Pfizers business,they are not within Pfizers control and because they can mask positive or negative trends in the business,Pfizer believes presenting operational variances excluding these foreign exchange changes provides useful information to evaluate Pfizers results.(4)Pfizer reaffirmed 2024 Gu

66、idance(last updated on October 29,2024)as of the publication of its December 17,2024 announcement.Within this presentation and other related materials,all references to Pfizers 2024 baseline guidance indicates our 2024 Guidance excluding 2024 non-recurring items.Our 2024 baseline Revenue guidance ra

67、nge excludes$1.2 billion in non-recurring 2024 Paxlovid revenues,and our baseline Adjusted(2)diluted EPS guidance range excludes an anticipated favorable impact in 2024 of approximately$0.30 from non-recurring items,as outlined on slide 8.(5)Revenues is defined as revenues in accordance with U.S.GAAP.Reported net income and its components are defined as net income attributable to Pfizer Imon shareholders and its components in accordance with U.S.GAAP.Reported diluted EPS is defined as diluted EPS attributable to Pfizer Imon shareholders in accordance with U.S.GAAP.