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辉瑞(PFIZER)2022年财报(英文版)(41页).pdf

1、Breakthroughs that change patients lives January 31,2023Fourth Quarter 2022 Earnings TeleconferenceIntroductionChristopher StevoSenior Vice President,Chief Investor Relations Officer3Fourth Quarter 2022 EarningsForward-Looking Statements and Non-GAAP Financial InformationOur discussions during this

2、conference call 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 include forward-looking statements about,among other topics,our anticipated opera

3、ting and financial performance;reorganizations;business plans,strategy and prospects;our Environmental,Social and Governance(ESG)priorities,strategy and goals;expectations for our product pipeline,in-line products and product candidates,including anticipated regulatory submissions,data read-outs,stu

4、dy starts,approvals,launches,clinical trial results and other developing data,revenue contribution and projections,pricing and reimbursement,potential market dynamics and size,growth,performance,timing of exclusivity and potential benefits;strategic reviews,capital allocation objectives,dividends an

5、d share repurchases;plans for and prospects of our acquisitions,dispositions and other business development activities;and our ability to successfully capitalize on these opportunities;manufacturing and product supply;our efforts to respond to COVID-19,including the Pfizer-BioNTech COVID-19 Vaccine(

6、Comirnaty),the Pfizer-BioNTech COVID-19 Omicron BA.4/BA.5-adapted bivalent Vaccine(the Pfizer-BioNTech COVID-19 bivalent vaccine),other vaccines that may result from the BNT162 program,and our oral COVID-19 treatment(Paxlovid);and our expectations regarding the impact of COVID-19 on our business,ope

7、rations 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 indications or combinations,i

8、ncluding expected clinical trial protocols,the timing of the initiation and progress of clinical trials and data read-outs from trials;the timing for the submission of applications for and receipt of regulatory approvals;the timing of product launches;expected profile and labeling;potential revenue;

9、and expected breakthrough,best or first-in-class or blockbuster status or expected market entry of our medicines or vaccines;the regulatory landscape;and the competitive landscape are forward-looking and are estimates that are subject to change and subject to,among other risks,assumptions and uncert

10、ainties,clinical trial,regulatory and commercial success,availability of supply and competitive and market dynamics.These statements are subject to risks,uncertainties and other factors that may cause actual results to differ materially from past results,future plans and projected future results.Add

11、itional information regarding these and other factors can be found in Pfizers Annual Report on Form 10-K for the fiscal year ended December 31,2021 and its subsequent reports on Form 10-Q,including in the sections thereof captioned“Risk Factors”and“Forward-Looking Information and Factors That May Af

12、fect Future Results”,as well as in our 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 rate fluctuat

13、ions and inflationary pressures and the impact of COVID-19 on our sales and operations,including impacts on employees,manufacturing,supply chain,marketing,research and development and clinical trials.The forward-looking statements in this presentation speak only as of the original date of this prese

14、ntation and we undertake no obligation to update or revise any of these statements.Also,the discussions during this conference call will include certain financial measures that were not prepared in accordance with U.S.generally accepted accounting principles(GAAP).Additional information regarding no

15、n-U.S.GAAP financial measures can be found on slides 29-32 and in our earnings release furnished with Pfizers Current Report on Form 8-K dated January 31,2023.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,hav

16、e no standardized meaning prescribed by U.S.GAAP and may not be comparable to the calculation of similar measures of other companies.Todays discussions and presentation are intended for the investor community only;they are not intended to promote the products referenced herein or otherwise influence

17、 healthcare 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.Opening Remark

18、sAlbert BourlaChairman and Chief Executive Officer5Fourth Quarter 2022 Earnings2022 Was an Outstanding Year for PfizerHistoric RevenuesAcceleratingR&D$100B+First time in our 174-year history1.3BPatients treated globally with our medicines and vaccines1Patients TreatedMaintained industry-leading clin

19、ical success rates and further improved cycle times1The Patients Treated metric is calculated from Pfizer and third-party datasets.Figures may be limited given the coverage provided by external sources(e.g.calendar duration,geographic&product coverage).Numbers are estimates and assume US-like produc

20、t usage and in some cases use global volume,daily dosage and#of treatment days to facilitate calculations and to extend applicability for the Rest of World.Methodologies to calculate estimates may vary by product type given the nature of the product and available data.Patients taking multiple Pfizer

21、 products may be counted as multiple patients towards total.Numbers include Access&Affordability patient estimates.Historical estimates may periodically be subject to revision due to restatements in the underlyingdata source.Ten Best Employer Lists6Fourth Quarter 2022 EarningsFY 2022 Revenues:Key Gr

22、owth Drivers$1.7B *opU.S.$1.7B,*Intl$38M,*op$6.5B +14%opU.S.$3.8B,+21%Intl$2.7B,+5%op$2.4B +29%opU.S.$1.2B,+37%Intl$1.2B,+22%opAdult*Indicates year-over-year growth calculation not meaningful.1See Slides 29-32 for definitions.2Eliquis Alliance revenues&direct sales.3Vyndaqel family includes global r

23、evenues from Vyndaqel,as well as revenues for Vyndamax in the U.S.and Vynmac in Japan.4 Reflects revenues since October 2022,when we acquired these products.3$18.9B *opU.S.$10.5B,*Intl$8.4B,*op$37.8B +10%opU.S.$8.8B,+12%Intl$29.0B,+9%op$213M *opU.S.$211M,*Intl$2M,*op$73M *opU.S.$72M,*Intl ,12family4

24、447Fourth Quarter 2022 EarningsAnticipated Near-Term Growth Excluding COVID-19 Products(2023 Guidance)7-9%*Excluding COVID-19 products and FX impactComprised of:Potential new launches Newly acquired products In-line productsExpect Strong RevenueOp Growth ex-COVID*Key Recent andPotential LaunchesIncr

25、eased SI&AInvestments.to support up to 19 recent and potential launches through H1 20241Products from recent BD activity:etrasimod Nurtec ODT/Vydura zavegepant OxbrytaPotential launches:RSV for older adults elranatamab ritlecitinib Prevnar 20 pediatricNote:Preliminary,subject to change,and subject t

26、o,among other risks,assumptions and uncertainties,clinical trial,regulatory and commercial success andavailability of supply.1 Through H1 2024,we expect to have up to 19 new products or indications in the market including the five for which we have already begun co-promotion orcommercialization in 2

27、022.See slide 37 in Appendix.2Anticipate expansion of indication to adolescents(12-18 year olds)in U.S.in 2023,if approved.$1.3BRecent launches:Cibinqo adult28Fourth Quarter 2022 EarningsAnticipated Long-Term Growth Excluding COVID-19 Products*For illustrative purposes only and not intended to be at

28、 scale.All values at constant exchange rates.1Assumes actual 2022 non-COVID revenues($43.6B)and 2022-2025 CAGR of 6%.Excludes 2022-2025 BD.2 Internal expected negative LOE impact from products with a 2021 total revenue base of$18B as shown on slide 36 in Appendix.3 Internal 2030 risk-adjusted revenu

29、e expectations for NME and new indications launches,excluding COVID-19 vaccine BA.4/BA.5 variant,as shown on first twosections of slide 37 in Appendix.4Risk-adjusted 2030 revenue goal from BD deals.5Potential 2030 risk-adjusted revenues for new product launches as shown on slide 38 in Appendix.Note:

30、Preliminary,subject to change,and subject to,among other risks,assumptions and uncertainties,clinical trial,regulatory and commercial success andavailability of supply.LOE=Loss of Exclusivity;NME=New Molecular Entity;BD=Business DevelopmentIllustrative*$25B4$20B3$17B2$52B122-25 CAGR 6%with new launc

31、hesNew launches$XB5$84B25-30 CAGR 10%$70B25-30 CAGR 6%Current products9Fourth Quarter 2022 EarningsAnticipated Long-Term COVID-19 U.S.VaccinationsCOVID Vx OnlyImpact of COVID/Flu ComboU.S.Population=331M12022Actual22023Expected2024Expected2025 Expected3,42026 Expected3,4Est.%Population Vaccinated fo

32、r COVID-1931%24%25%30%40%Est.#People Vaccinated for COVID-19(M)2Est.Average Doses/Vaccinated Patient1.41.31.31.21.2Total Market Doses Administered(M)1153Est.Pfizer Market Share(%)64%64%64%64%64%Total Pfizer Doses Administered(M)9265677798Note:Expected timing;all dates are preli

33、minary,subject to change,and subject to,among other risks,assumptions and uncertainties,clinical trial and regulatory success and availability of supply.1 World Population Prospects-Population Division-United Nations,data accessed April 2022.2Centers for Disease Control and Prevention-COVID Data Tra

34、cker and Pfizer internal analysis.3Assumes successful development,approval and launch of COVID/Influenza mRNA combination vaccine.4 Includes COVID/Influenza mRNA combination vaccine10Fourth Quarter 2022 EarningsCustomer inventorybuildDosesSold12Anticipated Long-Term Comirnaty U.S.Doses SoldCustomeri

35、nventoryabsorptionIllustrative and Not to ScaleNote:Expected timing;all dates are preliminary,subject to change,and subject to,among other risks,assumptions and uncertainties,clinical trial and regulatory success and availability of supply.1Pandemic Price2 In 2023,we expect the majority of sales in

36、the U.S.to be at commercial price,except for relatively minor deliveries under the last U.S.Government contract.3Commercial PriceDosesUsedDosesSold2DosesUsedDosesSold3DosesUsedDosesSold3DosesUsedDosesSold3DosesUsed11Fourth Quarter 2022 EarningsAnticipated Long-Term Global COVID-19 Oral Therapies Uti

37、lization(Excluding China)2022 Benchmark2023 Expected2024 Expected2025 Expected2026 ExpectedEst.#of Total Reported Symptomatic Infections(M)17119Est.%of Symptomatic Patients Treated with Oral Therapy12%217%19%21%22%Est.#of Symptomatic Patients Treated with Oral Therapy(M)Est.Pax

38、lovid Share of Oral Antiviral Market86%2(approaching 91%at year end)*90%90%85%80%Est.Total Demand for Paxlovid(treatment courses in M)122,317192121Note:Expected timing;all dates are preliminary,subject to change,and subject to,among other risks,assumptions and uncertainties,clinical trial and regula

39、tory success and availability of supply.1Varied in 2022 depending on how markets changed their approach to reporting infections,where PAXLOVID is available.Only includes individuals age 12+/18+where authorized/approved in accordance with local labeling2Derived from IQVIA and internal market research

40、.3Based on supply constraints in Q1 2022,resulting in 9 months of Paxlovid utilization during the year.*In major markets12Fourth Quarter 2022 EarningsCustomer inventorybuildTherapiesSold1TherapiesUsed2Anticipated Long-Term Global Paxlovid Treatment Courses Sold(Excluding China)Customer inventoryabso

41、rptionIllustrative and Not to ScaleTherapiesSold2TherapiesUsedTherapiesSold3TherapiesUsedTherapiesSold3TherapiesUsedTherapiesSold3TherapiesUsedNote:Expected timing;all dates are preliminary,subject to change,and subject to,among other risks,assumptions and uncertainties,clinical trial and regulatory

42、 success and availability of supply.1Pandemic Price2 2023 will be a blend of pandemic price and commercial price.3Commercial Price13Fourth Quarter 2022 EarningsIncreased Demand for Paxlovid in China Since Fiscal 2022Fiscal 20221Dec 2022-Mar 2023From April 2023New but uncertain market opportunity,shi

43、pped only tens of thousands of coursesGovernment-Reimbursement Pre-NRDL2;since December*we shipped millions of courses,expect this to continue through March*first month of non-U.S.fiscal yearPotential for Private Market Self-Pay Sales via non-government hospitals and channels1See Slides 29-32 for de

44、finitions.2National Reimbursement Drug List.14Fourth Quarter 2022 EarningsFurther Strengthening our ROI for R&DDelivering PotentiallyHigher R&DROIs vs.PastReaching Potentially Larger Opportunities on AverageGoal to further improvecycle times AcceleratingEnd-to-EndCycle TimesSustaining Industry-Leadi

45、ngEnd-to-EndSuccess Rates1Reducing Development Cost per Molecule2%21%201020215%12%PfizerIndustryKey Drivers GLP-1 elranatamab mRNA&respiratory Vx IFN-1FIH to Approval success rates and median phase cycle times are based on 3-year rolling cohort for Phase 1 and 5-year rolling cohort for Phase 2 to Re

46、gistration.The analysis is at the new molecular entity(NME)level.The“industry”in this analysis was based on the Pharmaceutical Benchmarking Forums companies-Current participants:AbbVie,Inc.;Astellas Pharma,Inc.;Bayer AG;Bristol-Myers Squibb Company;Eli Lilly and Company;Gilead Sciences,Inc.;Johnson&

47、Johnson Corporation;Merck&Co,Inc.;Novartis AG;Pfizer;Roche,Inc.and Sanofi S.A.Industry-leading is defined as Top Quartile amongst CMR Benchmark.FIH=First in Human;NME=New Molecular Entity;AI=Artificial Intelligence;ML=Machine Learning Accelerating recruitment Innovating trial design Leveraging AI/ML

48、,Digital Optimizing regulatory engagementFinancial ReviewDavid DentonChief Financial Officer,Executive Vice President16Fourth Quarter 2022 EarningsQuarterly Income Statement HighlightsRevenuesAdjusted1R&D ExpensesAdjusted1Cost of SalesDiluted EPSAdjusted1SI&A ExpensesFX Impacts$24.3B +13%opPrimarily

49、 driven by Comirnaty1in dev markets,Paxlovid ex-U.S.,Prevnar family in U.S.,Nurtec ODT/Vydura and Oxbryta,Vyndaqel family,Eliquis in U.S.,and Prevenar 13 in EM;ex-Comirnaty and Paxlovid,revenues grew 5%op$9.5B +9%op39%2-1.7 pptsDecrease in COS%primarily due to favorable changes in sales mix,includin

50、g increased sales of Paxlovid and higher alliance revenues,as well as favorable FX impactsRep.1$0.87+48%Adj.1$1.14+69%opIncrease in Adjusted Diluted EPS1was primarily driven by strong sales growth and lower acquired in-process R&D expenses$3.6B +7%opPrimarily driven by increased costs to support var

51、ious vaccine and oncology programs and recently acquired assets$4.4B +17%opPrimarily driven by increased investments to support Paxlovid,Comirnaty1and recently acquired and launched productsRevenue$2.5B -11%Adj.Dil.EPS1$0.19 -24%Primarily driven by USD strengthening against Euro,Japanese Yen,and U.K

52、.Pound1 See Slides 29-32 for definitions.2 Adjusted1cost of sales as a percentage of revenues(COS%).EM=Emerging Markets17Fourth Quarter 2022 Earnings2023 Financial Guidance1:Revenues and Adjusted1Diluted EPSMidpoint of Revenue Range Reflects 31%Op Decline Compared to 2022 Revenues;Midpoint of Adjust

53、ed Diluted EPS1Range Reflects 49%Op DeclineCompared to 20221 See Slides 29-32 for definitions and for additional information regarding Pfizers 2023 financial guidance.2022 Actual Results2023 Financial GuidanceRevenues$100.3 billion$67.0 to$71.0 billionOperational1Growth/(Decline)vs.Prior Year30%(33%

54、)to(29%)Growth/(Decline)vs.Prior Year23%(33%)to(29%)Adjusted1Diluted EPS$6.58$3.25 to$3.45Operational1Growth/(Decline)vs.Prior Year71%(50%)to(47%)Growth/(Decline)vs.Prior Year62%(51%)to(48%)18Fourth Quarter 2022 Earnings2023 Financial Guidance1:Other ComponentsAdjusted1Cost of Sales as a Percentage

55、of Revenues28.0%to 30.0%Adjusted1SI&A Expenses$13.8 to$14.8 BillionAdjusted1R&D Expenses$12.4 to$13.4 BillionAcquired IPR&D Expenses1,2Approximately$0.1 billionAdjusted1Other(Income)/DeductionsApproximately$1.5 billion of incomeEffective Tax Rate on Adjusted1IncomeApproximately 15.0%1 See Slides 29-

56、32 for definitions and for additional information regarding Pfizers 2023 financial guidance.2We do not budget acquired IPR&D for unsigned deals.19Fourth Quarter 2022 Earnings2023 Financial Guidance:Key Assumptions(1 of 2)Key Assumptions for 2023 GuidanceCommentaryOperational revenue growth compared

57、to 2022 excluding COVID-19 products7%to 9%Growth expected to be split among each of three categories:launch,acquired and in-line productsIncremental SI&A spend to support anticipated new launches,acquired assets and commercial launch of COVID-19 products$1.3 billionInvestments to support short-and l

58、ong-term growth aspirationsIncremental R&D spend to support high-value pipeline programs and acquired assets$1.5 billionIncludes,among others:GLP-1,elranatamab,respiratory combination vaccines20Fourth Quarter 2022 EarningsComirnaty-2023 Guidance AssumptionsCommentaryEstimated proportion of U.S.popul

59、ation that receives a vaccine24%Compared to 31%in 2022;Decrease due to fewer primary vaccinations and lower complianceEstimated number of doses per vaccinated person per year,on average1.3 dosesCompared to 1.4 dosesin 2022;Decrease due to fewer primary vaccinationsEstimated Comirnaty market share-U.

60、S.64%Consistent with share achieved with most recent bivalent booster in 2022Estimated total demand for Comirnaty doses-U.S.(includes use of existing government supply)65 million dosesCompared to 92 million dosesin 2022Assumed timing for delivery of the contracted doses of Comirnaty to the European

61、CommissionRe-phased over multiple years (not all in 2023)Negotiations on re-phasing of delivery timelines are ongoingPaxlovid-2023 Guidance AssumptionsCommentaryEstimated number of total reported symptomatic infections-global*,excluding China112 millionCompared to 110 millionin 2022;Increase due to

62、expected waning of population immune protection due to reduced vaccination ratesEstimated proportion of symptomatic COVID-19 patients treated with an oral antiviral treatment-global*,excluding China17%Compared to 12%in 2022(partial year only);Increase due to greater awareness/education and full-year

63、 implementationEstimated Paxlovid share of oral antiviral market-global*,excluding China90%Consistent with share achieved in 2022Estimated total demand for Paxlovid-global*,excluding China(includes use of existing government supply)17 million coursesCompared to 12 million coursesin 2022(partial year

64、 only);Increase due to broad product availability,greater awareness/education and full-year implementationPaxlovid sales to ChinaAssumes no sales after April 1,2023Temporary National Reimbursement Drug List currently set to end on April 1,2023General-2023 Guidance AssumptionCommentaryEstimated timin

65、g for transitioning Comirnaty and Paxlovid to commercial market in the U.S.Second half of 2023Assumes prior absorption of existing government supply2023 Financial Guidance:Key Assumptions(2 of 2)*Only includes markets where Paxlovid is available,and only includes individuals age 12+/18+where authori

66、zed/approved in accordance with local labeling.Actual 2022 market data is derived from a combination of public data sources and internal market research.Scientific UpdatesMikael DolstenChief Scientific Officer and President,Worldwide Research,Development and Medical22Fourth Quarter 2022 EarningsDriv

67、ing Change From A Position of StrengthDelivering potential breakthroughs on a new scalePursuing External InnovationFocus where our scientific and business capabilities are uniqueInnovate in medicine design and lightspeed development to further improve industry leading success rates and cycle timesRe

68、think our approach to Rare Disease Honing Internal FocusLeverage the best external and internal science to reach the most patients,as quickly as possibleActively pursue external biotech innovation and emerging platforms Aggressively access external differentiated medicines and vaccines23Fourth Quart

69、er 2022 EarningsTransformative Potential in Inflammation&ImmunologyNear-term potential blockbusters and early-stage multispecific monoclonal antibody platform innovationPotential Blockbuster Launches and Pivotal StartsEtrasimod Ritlecitinib Anti-IFN-Phase 1 IV PK Profiles:Encouraging profile at init

70、ial dose levelsPotential for improved efficacy in Atopic Dermatitis via more potent IL-4/-13 neutralization plus:Expanded breadth of efficacy by blocking TSLPORRapid,enhanced itch reduction by blocking IL-33Next-Wave Pipeline InnovationAtopic Dermatitis Tri-specific mAbsSingle drug targets 3 cytokin

71、es Potential for improved efficacy for clinically validated targetsPhase 1 Tri-specific mAb Candidates:Anti-IL-4/-13/TSLP and Anti-IL-4/-13/-33 3mg IV IL4/13/33 3mg IV IL4/13/TSLP mAb:monoclonal antibody;IL:Interleukin;TSLP:Thymic stromal lymphopoietin;IV:IntravenousPreliminary,subject to change,and

72、 subject to,among other risks,assumptions and uncertainties,clinical trial,regulatory and commercial success and availability of supply24Fourth Quarter 2022 EarningsPreclinicalPhase 1Phase 2RegistrationalOncologyMultiple Myeloma ElranatamabLymphomas,MM TTI-622Sickle CellSickle Cell Disease VOC Incla

73、cumabSickle Cell Disease GBT-601Sickle Cell Disease VOC Anti-E-SelectinHemophiliaHemophilia B FidaVec GTxHemophiliaA GiroctoVec GTxHemophilia A/B MarstacimabStrengthening Leadership in HematologyIn-line portfolio and pipeline with blockbuster potentialSelect examplesGTx:Gene Therapy;MM:Multiple myel

74、oma;VOC:Vaso-occlusive crisis;Preliminary,subject to change,and subject to,among other risks,assumptions and uncertainties,clinical trial,regulatory and commercial success and availability of supply Study Phase:25Fourth Quarter 2022 EarningsElranatamab:Potential BCMA Leadership in Multiple Myeloma T

75、ransformative potential based on Phase 2 MagnetisMM-3 data at ASH 20221Achieved in Heavily Pre-treated MM Patient Population,Representing Highest Unmet NeedPotential Differentiation in Bi-specific mAb Class in Efficacy&Safety2Objective Response RateEarly and Deep Responses61%ORR1.Abstract 159 ASH 20

76、22;BCMA:B Cell Maturation Antigen;MM:Multiple Myeloma;ASH:American Society of Hematology;CR:Complete Response;ORR:Objective Response Rate;PR:Partial Response;sCR:stringent Complete Response;VGPR:Very Good Partial Response;CRS:Cytokine Release Syndrome;BsAb:Bispecific antibody;Expected timing:all dat

77、es are preliminary,subject to change,and subject to,among other risks,assumptions and uncertainties,clinical trial,regulatory and commercial success and availability of supply84%Probability of Maintaining Response at 9 monthsManageable Safety Profile56%CRS(all Gr1/2)0%Gr3 CRSPR(5.7)VGPR(27.6)CR(14.6

78、)sCR(13.0)020406080Cohort A(n=123)Patients,%CR:27.6%VGPR:55.3%Potential Approval in 2023 for triple-class exposed patients Estimated potential peak revenue over$4B across multiple treatment lines with studies ongoing2Cannot draw definitive conclusions without head-to-head data26Fourth Quarter 2022 E

79、arningsGBT-601:Transformative Potential in Sickle Cell DiseasePhase 1 data support potentially best-in-class profile of once-daily,oral,next-generation candidateASH 2022 Oral Presentation 10;ASH:American Society of Hematology;Hb:Hemoglobin;HbS:sickle hemoglobin;MAD:Multiple Ascending Dose;RBC:Red Bl

80、ood Cell;qd:once daily;Cmax:maximum concentration;Expected timing:all dates are preliminary,subject to change,and subject to,among other risks,assumptions and uncertainties,clinical trial,regulatory and commercial success and availability of supply%Hb Occupancy After Multiple Doses of GBT-601 in Pha

81、se 1 MAD StudyPhase 1 Study:Multiple ascending doses to reach a 30%Hb occupancy with maintenance doses of 50mg,100mg and 150mgNext-Generation HbS Polymerization Inhibitor Phase 1 MAD Data Presented at ASH 2022 Demonstrate:Improvements in hematocrit and Hb levels over timeDose-responsive increases in

82、 Hb occupancyMean Hb occupancy greater than 30%at 100mg and 150mg maintenance dosesImprovements in RBC health at 100mg and 150mgWell-tolerated daily maintenance dosesPhase 2/3 Study Ongoing with Potential NDA Approval in 2027a.Hb occupancy is calculated from the start of week 5,week 4,and week 6 of

83、daily dosing for the 50,100,and 150 mg dose levels,respectively.Preliminary analysis based on apparent Cmax.b.Hb occupancy data from patient 0003 at 150 mg were excluded due to lack of adherence.c.Two patients did not move forward with the MAD-3 portion of the study because they initiated disease-mo

84、difying therapy before the start of MAD-3.27Fourth Quarter 2022 EarningsExpanding Leadership in Breast CancerNext-generation oral CDK4i:Potential to address unmet needs in hormonally driven cancersEarly efficacy and durability data in combination with ETConfirmed ORR nearly 30%CBR approximately 50%M

85、edian PFS:24.7 weeksInvestigator-assessedWell tolerated with reduced hematologic AEs based on early data Gr 3 neutropenia=15%Potential to Improve Upon Current Standard of Care by Maximizing CDK4 Target Coverage12Additional data from complementary portfolio of next-wave breast cancer candidates antic

86、ipated H1 2023 CDK4i randomized study initiation anticipated before year-end 2023CDK4i:cyclin dependent kinase 4 inhibitor;CDK4:cyclin dependent kinase 4;ET:endocrine therapy;HR+:hormone receptor positive;HER2:human epidermal growth factor receptor 2;MBC:metastatic breast cancer;LET:letrozole;PR:par

87、tial response;ORR:overall response rate;CBR:clinical benefit rate;PFS:progression free survival;AEs:adverse events;Expected timing:all dates are preliminary,subject to change,and subject to,among other risks,assumptions and uncertainties,clinical trial,regulatory and commercial success and availabil

88、ity of supplyBaselineCDK4i+LET Week 24*Patient:ER+/HER2-metastatic breast cancerPrior therapies:ET+CDK4/6 inhibitor,fulvestrant,chemotherapy Confirmed PR,on treatment for 47 weeksCDK4i PF-07220060 Phase 1 Dose Escalation28Fourth Quarter 2022 EarningsPAXLOVID NDA Approval2ndGen COVID-19 Antiviral Ph

89、2 Study StartSisunatovir RSV Antiviral Ph 3 Study StartIBRANCE PATINA HER2+Ph 3 DataARV-471 Ph 3 Study StartCDK4i Ph 2 DataKAT6i Ph 2 DataZavegepant Acute Migraine LaunchDanuglipron(GLP-1)Ph 2b Data Lotiglipron(PF1532)(GLP-1)Ph 2b DataEtrasimod UC LaunchRitlecitinib AA LaunchCIBINQO Adolescent AD La

90、unchAnti-IFN Ph 3 StartMenABCWY LaunchPREVNAR 20 Peds LaunchOlder Adult and Maternal RSV LaunchesGroup B Strep Ph 3 StartmodFlu mRNA Ph 3 DataZoster mRNA Ph 1/2 Study StartRespiratory Combo Study StartInflammation&ImmunologyStrong Execution and Next Wave CandidatesAnticipating a milestone rich 18 mo

91、nths across potential launches and key pipeline catalystsOncology:Breast CancerAnti-InfectivesVaccinesInternal MedicineExpected timing:all anticipated milestones are preliminary,subject to change,and subject to,among other risks,assumptions and uncertainties,clinical trial,regulatory and commercial

92、success,ACIP,MMWR publication,and availability of supply;Ph:Phase;GTx:Gene Therapy;RSV:Respiratory syncytial virus;UC:Ulcerative colitis;AA:Alopecia areata;AD:Atopic dermatitis;NDA:US FDA New Drug Application29Fourth Quarter 2022 EarningsFootnotes(Page 1 of 4)(1)As used in this document,“Comirnaty”r

93、efers to,as applicable,and as authorized or approved,the Pfizer-BioNTech COVID-19 Vaccine,the Pfizer-BioNTech COVID-19 Vaccine,Bivalent(Original and Omicron BA.4/BA.5),the Comirnaty Original/Omicron BA.1 Vaccine,and Comirnaty Original/Omicron BA.4/BA.5 Vaccine.“Comirnaty”includes direct sales and al

94、liance revenues related to sales of the above-mentioned vaccines,which are recorded within Pfizers Primary Care customer group.It does not include revenues for certain Comirnaty-related manufacturing activities performed on behalf of BioNTech,which are included in the Pfizer CentreOne contract devel

95、opment and manufacturing organization.Revenues related to these manufacturing activities totaled$80 million and$188 million for the fourth-quarter and full-year 2022,respectively,and$46 million and$320 million for the fourth-quarter and full-year 2021,respectively.(2)Revenues is defined as revenues

96、in accordance with U.S.generally accepted accounting principles(GAAP).Reported net income and its components are defined as net income attributable to Pfizer Inc.and its components in accordance with U.S.GAAP.Reported diluted earnings per share(EPS)is defined as diluted EPS attributable to Pfizer Im

97、on shareholders in accordance with U.S.GAAP.(3)Adjusted income and Adjusted diluted EPS are defined as U.S.GAAP net income attributable to Pfizer Imon shareholders and Reported diluted EPS attributable to Pfizer Imon shareholders before the impact of amortization of intangible assets,certain acquisi

98、tion-related items,discontinued operations and certain significant items.See the reconciliations of certain GAAP Reported to Non-GAAP Adjusted information for fourth quarter and the full-year 2022 and 2021 in Pfizers earnings release furnished with Pfizers Current Report on Form 8-K dated January 31

99、,2023.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(2).See the Non-GAAP Financial Measure:Adjusted Income sections of Managements Discussion and Analysis of Financial Con

100、dition and Results of Operations in Pfizers 2021 Annual Report on Form 10-K and Quarterly Report on Form 10-Q for the quarterly period ended October 2,2022 and the Non-GAAP Financial Measure:Adjusted Income section of Pfizers earnings release furnished with Pfizers Current Report on Form 8-K dated J

101、anuary 31,2023 for a definition of each component of Adjusted income as well as other relevant information.(4)Pfizer does not provide guidance for GAAP Reported financial measures(other than revenues and acquired IPR&D expenses)or a reconciliation of forward-looking non-GAAP financial measures to th

102、e 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 unusual gains and losses,certain acquisition-related expenses,gains and losses from equity securities,actuarial gains and losses fr

103、om pension and postretirement plan remeasurements,potential future asset impairments and pending litigation without unreasonable effort.These items are uncertain,depend on various factors,and could have a material impact on GAAP Reported results for the guidance period.Financial guidance for full-ye

104、ar 2023 reflects the following:Does not assume the completion of any business development transactions not completed as of December 31,2022,except for signed transactions,if any,through mid-January 2023,which are expected to give rise to acquired in-process R&D(IPR&D)expenses during fiscal 2023.Refl

105、ects an anticipated negative revenue impact of$0.3 billion due to recent and expected generic and biosimilar competition for certain products that have recently lost patent protection or that are anticipated to lose patent protection during fiscal-year 2023.30Fourth Quarter 2022 EarningsFootnotes(Pa

106、ge 2 of 4)Exchange rates assumed are as of mid-January 2023.Financial guidance reflects the anticipated unfavorable impact of approximately$0.2 billion on revenues and approximately$0.02 on Adjusted diluted EPS(3)as a result of changes in foreign exchange rates relative to the U.S.dollar compared to

107、 foreign exchange rates from 2022.Guidance for Adjusted diluted EPS(3)assumes diluted weighted-average shares outstanding of approximately 5.75 billion shares,and assumes no share repurchases in 2023.(5)Pfizers fiscal year-end for international subsidiaries is November 30 while Pfizers fiscal year-e

108、nd for U.S.subsidiaries is December 31.Therefore,Pfizers fourth quarter and full year for U.S.subsidiaries reflects the three and twelve months ended on December 31,2022 and December 31,2021 while Pfizers fourth quarter and full year for subsidiaries operating outside the U.S.reflects the three and

109、twelve months ended on November 30,2022 and November 30,2021.(6)Beginning in the third quarter of 2022,Pfizer made several organizational changes to further transform its operations to better leverage its expertise in certain areas and in anticipation of potential future new product or indication la

110、unches.Biopharma,Pfizers innovative science-based biopharmaceutical business,is operating under a new commercial structure which is designed to better support and optimize performance across three broad customer groups:Primary Care,consisting of the former Internal Medicine and Vaccines product port

111、folios,products for COVID-19 prevention and treatment,and potential future mRNA and antiviral products.Specialty Care,consisting of the former Inflammation&Immunology,Rare Disease and Hospital(excluding Paxlovid)product portfolios.Oncology,consisting of the former Oncology product portfolio.(7)The f

112、ollowing business development activity,among others,impacted financial results for the current or prior fiscal year:On October 5,2022,Pfizer announced the completion of its acquisition of Global Blood Therapeutics,Inc.(GBT)for$68.50 per share in cash,for payments of approximately$5.3 billion,net of

113、cash acquired,plus repayment of third-party debt of$331 million for a total net cash deployment of approximately$5.6 billion.On October 3,2022,Pfizer announced the completion of its acquisition of all the outstanding shares of Biohaven Pharmaceutical Holding Company Ltd.(Biohaven)not already owned b

114、y Pfizer for$148.50 per share in cash,for payments of approximately$11.4 billion,net of cash acquired,plus repayment of third-party debt of$863 million and redemption of Biohavens redeemable preferred stock for$495 million,for a total net cash deployment of approximately$12.7 billion.Effective immed

115、iately prior to the closing of the acquisition,Biohaven completed the spin-off of Biohaven Ltd.(NYSE:BHVN),a new company that retained Biohavens non-calcitonin gene-related peptide(CGRP)development stage pipeline compounds.Shares of Biohaven Ltd.were distributed to Biohavens shareholders.Pfizer,a Bi

116、ohaven shareholder,received a pro rata portion of the companys shares in the distribution and currently owns approximately 1.5%of Biohaven Ltd.On July 18,2022,GlaxoSmithKline plc.(GSK)completed its demerger of the Consumer Healthcare joint venture which became Haleon,an independent,publicly traded c

117、ompany listed on the London Stock Exchange that holds the joint Consumer Healthcare business of GSK and Pfizer following the demerger.For additional information,see Note 2C to the condensed consolidated financial statements in Pfizers Quarterly Report on Form 10-Q for the quarterly period ended Octo

118、ber 2,2022.31Fourth Quarter 2022 EarningsFootnotes(Page 3 of 4)On June 9,2022,Pfizer announced the completion of its acquisition of ReViral Ltd.,a privately held,clinical-stage biopharmaceutical company focused on discovering,developing and commercializing novel antiviral therapeutics that target re

119、spiratory syncytial virus,for a total consideration of up to$536 million,including upfront and development milestones.In connection with the closing of the transaction,Pfizer recorded$426 million of acquired IPR&D expenses in its international third-quarter 2022.On March 11,2022,Pfizer announced the

120、 completion of its acquisition of Arena Pharmaceuticals,Inc.,a clinical-stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases,for$100 per share,in cash.The total fair value of the consideration transferred was$6.6 billion($6.2 billion,net o

121、f cash acquired),plus$138 million in payments to Arena employees for previously unvested equity compensation awards recognized as an expense,for a total net cash deployment of$6.4 billion.On December 31,2021,Pfizer completed the sale of its Meridian subsidiary,the manufacturer of EpiPen and other au

122、to-injector products,which generated approximately$300 million in annual revenues and which previously had been managed within the former Hospital therapeutic area.Beginning in the fourth quarter of 2021,the financial results of Meridian are reflected as discontinued operations for all periods prese

123、nted.On December 24,2021,Pfizer entered into a multi-year research collaboration with Beam Therapeutics Inc.(Beam)to utilize Beams in vivo base editing programs,which use mRNA and lipid nanoparticles,for three targets for rare genetic diseases of the liver,muscle and central nervous system.Under the

124、 terms of the agreement,Pfizer paid Beam a$300 million upfront payment.If Pfizer elects to opt in to licenses for all three targets,Beam would be eligible for up to an additional$1.05 billion in development,regulatory and commercial milestone payments for a potential total deal consideration of up t

125、o$1.35 billion.Beam is also eligible to receive royalties on global net sales for each licensed program.On November 17,2021,Pfizer acquired all outstanding shares,warrants,options and deferred shares not already owned by Pfizer of Trillium Therapeutics Inc.,a clinical-stage immuno-oncology company d

126、eveloping therapies targeting cancer immune evasion pathways and specific cell targeting approaches,for a price of$18.50 per share in cash,for total consideration of$2.0 billion,net of cash acquired.Pfizer accounted for the transaction as an asset acquisition since the lead asset,TTI-622,represented

127、 substantially all of the fair value of the gross assets acquired.As a result,Pfizer recorded a$2.1 billion charge in fourth-quarter 2021,representing the acquired in-process R&D asset.On November 9,2021,Pfizer and Biohaven announced a strategic collaboration and license agreement for Pfizer to comm

128、ercialize rimegepant and zavegepant for the treatment and prevention of migraines outside of the U.S.,subject to regulatory approval.Upon the closing of the transaction on January 4,2022,Pfizer paid Biohaven$500 million,including an upfront payment of$150 million and an equity investment of$350 mill

129、ion.Pfizer recognized$263 million for the upfront payment and premium paid on its equity investment in acquired IPR&Dexpenses.On July 22,2021,Arvinas Inc.(Arvinas)and Pfizer announced a global collaboration to develop and commercialize ARV-471,an investigational oral PROTAC(PROteolysis TArgeting Chi

130、mera)estrogen receptor protein degrader.The estrogen receptor is a well-known disease driver in most breast cancers.Under the terms of the agreement,Pfizer paid Arvinas$650 million upfront and made a$350 million equity investment in Arvinas.Arvinas is also eligible to receive up to$400 million in ap

131、proval milestones and up to$1 billion in commercial milestones.The companies will equally share worldwide development costs,commercialization expenses and profits.(8)References to operational variances in this presentation pertain to period-over-period changes that exclude the impact of foreign exch

132、ange rates.Although exchange rate changes are part of Pfizers business,they are not within Pfizers control and since they can mask positive or negative trends in the business,Pfizer believes presenting operational variances excluding these foreign exchange changes provides useful information to eval

133、uate Pfizers results.32Fourth Quarter 2022 EarningsFootnotes(Page 4 of 4)(9)Paxlovid and emergency uses of the Pfizer-BioNTech COVID-19 Vaccine or the Pfizer-BioNTech COVID-19 Vaccine,Bivalent(Original and Omicron BA.4/BA.5),have not been approved or licensed by the FDA.Paxlovid has not been approve

134、d,but has been authorized for emergency use by the FDA under an EUA,for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients(12 years of age and older weighing at least 40 kg 88 lbs)with positive results of direct SARS-CoV-2 viral testing,and who are at high-risk for progressi

135、on to severe COVID-19,including hospitalization or death.Emergency uses of the Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine,Bivalent have been authorized by the FDA under an EUA to prevent COVID-19 in individuals aged 6 months and older.The emergency uses are only author

136、ized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product during the COVID-19 pandemic under Section 564(b)(1)of the FFDCA unless the declaration is terminated or authorization revoked sooner.Please see the EUA Fact Sheets

137、at and www.cvdvaccine-.The information contained on our website or any third-party website is not incorporated by reference into this presentation.Appendix34Fourth Quarter 2022 EarningsQ4 2022 Summary Figures(1 of 2)Revenue by Therapeutic Area($M)Total$24,290Top 7 Products by Revenue1($M)Primary Car

138、eSpecialty CareOncologyPC1Total20%-3%-3%1%13%Operational GrowthTotal$24,290Comirnaty2PaxlovidPrevnar family3Eliquis4IbranceVyndaqel family5Xeljanz3%*40%5%-4%31%-28%Operational Growth*Indicates calculation not meaningful.1 Product percentages are calculated using total company revenue as denominator.

139、2 See Slides 29-32 for definitions.3Prevnar family include revenues from Prevnar 13/Prevenar 13(pediatric and adult)and Prevnar 20/Apexxnar(adult).4 Eliquis alliance revenues&direct sales.5Vyndaqel family includes global revenues from Vyndaqel,as well as revenues for Vyndamax in the U.S.and Vynmac i

140、n Japan.PC1=Pfizer CentreOne243535Fourth Quarter 2022 EarningsQ4 2022 Summary Figures(2 of 2)Revenue by Therapeutic Area,Ex-COVID1($M)Total$11,12746%of Total RevenueRevenue by Geography($M)Primary CareSpecialty CareOncologyPC1Total22%-3%-3%1%5%Operational Growth Ex-COVID1Total$24,290US2Dev EUDev ROW

141、EMTotal10%86%59%-51%13%Operational Growth1 Excludes revenues from Comirnaty direct sales and alliance revenues and Paxlovid.Product percentages are calculated using$11,127Mas denominator,as opposed to total company revenue.2U.S.%presented here is%Reported Growth.PC1=Pfizer CentreOne;US=United States

142、;EU=European Union;ROW=Rest of the World;EM=Emerging Markets36Fourth Quarter 2022 EarningsKey Products Included in the Expected$17 Billion in LOE Revenue Declines from 2025-2030Product2021 WW Revenues($millions)2021 U.S.Revenues($millions)2021 Dev.EU Revenues($millions)Year of Expected U.S.LOEYear o

143、f Expected EU LOEEliquis1$5,970$3,160$1,5202026*2026Inlyta$1,002$599$Ibrance$5,437$3,418$1,04420272028Xeljanz$2,455$1,647$30820252028Xtandi2$1,185$1,185N/A2027N/AVyndaqel family3$2,015$909$5722024(2028 pending PTE)2026*Date is based on the composition of matter patent.See Pfizers 2021 Ann

144、ual Report on Form 10-K filed with the U.S.Securities and Exchange Commission for more information about potential scenarios that could affect the timing of generic entry in the U.S.1Eliquis alliance revenues&direct sales.2Xtandi alliance revenues.3Vyndaqel family includes global revenues from Vynda

145、qel,as well as revenues for Vyndamax in the U.S.and Vynmac in Japan.PTE=Patent Term Extension LOE=Loss of Exclusivity37Fourth Quarter 2022 EarningsNew Launches/Co-promotions and Potential Product Launches1Note:All dates are preliminary,subject to change,and subject to,among other risks,assumptions a

146、nd uncertainties,clinical trial,regulatory and commercial success and availability of supply.1.Through H1 2024,we expect to have up to 19 new products or indications in the market including the five for which we have already begun co-promotion orcommercialization in 2022.2.Internal 2030 risk-adjuste

147、d revenue expectations for NME and new indications launches,excluding COVID-19 vaccine BA.4/BA.5variant.3.Risk-adjusted 2030 revenue goal from BD deals.4.Expected to contribute toward risk-adjusted 2030 revenue goal of$25B from BD deals.5.Through a standalone detailing arrangement.Vaccines Inflammat

148、ion/Immunology OncologyRare DiseaseInternal Medicine$20BPotential Revenueexpected for NME andnew indications by 20302$25BPotential Revenueexpected from newBD deals by 203032022Ngenla(Ex-US)Growth Hormone Deficiency2023RitlecitinibAlopeciaAreata2023ElranatamabTriple Class Relapsed or Refractory Multi

149、ple Myeloma1H 2023*RSV Adults(60+)VaccinePrevention of RSV-associated LRTI in adults 60 yrs2H 2023*RSV Maternal VaccinePrevention of RSV-associated LRTI in infantsvia maternal immunization2H 2023*Pentavalent Meningococcal VaccinePrevention of meningococcal infection by serogroups ABCWY2023AbriladaAd

150、alimumab Biosimilar2024*mRNA Flu VaccineInfluenzaNew Molecular Entity(NME)LaunchesAug 2022Pfizer co-promoteMyfembree EndometriosisSep 2022COVID-19 vaccine BA.4/BA.5 variantCOVID-192023CibinqoModerate to severe Atopic DermatitisAdolescent2023Braktovi/MektoviNon-Small Cell Lung Cancer(PHAROS)2023Talze

151、nna+Xtandi(Talazoparib+Enzalutamide)Metastatic castration resistant prostate cancer(TALAPRO2)2023XtandiNon-Metastatic Castration Sensitive Prostate Cancer(EMBARK)1H 2023*Prevnar 20 PedsPrevention of invasive pneumococcal disease,otitis media-PediatricNew IndicationsAug 2022 Pfizer promotion5Nurtec O

152、DT/VyduraAcute treatment of Migraine and preventive treatment of episodic Migraine2023Zavegepant(intranasal)Acute treatment of MigraineOct 2022 with merger closeOxbrytaSickle cell disease2H 2023EtrasimodModerate to severe Ulcerative ColitisRecently Announced Business Development(BD)Deals4*Estimated

153、FDA decision;subject to regulatory approval,ACIP and MMWR to follow.38Fourth Quarter 2022 EarningsIntroductionProduct CandidateAnticipated Indication(s)Expected Potential LaunchNew Molecular Entity(NME)LaunchesDanuglipron or PF1532(oral GLP1s)Type 2 Diabetes,Obesity2024Anti-IFN-Antibody(PF3859)Derma

154、tomyositis,Polymyositis2024COVID/Influenza mRNA Combination Vaccine1COVID-19&Influenza prevention2024Lyme Disease Vaccine(PF405)Lyme disease prevention2024mRNA Shingles Vaccine1Shingles(VZV)prevention2024HemA GTxHemophilia A gene therapy2024HemB GTxHemophilia B gene therapy2024DMD GTxDuchenne Muscul

155、ar Dystrophy gene therapy2024sasanlimabNon-muscle invasive bladder Cancer2024marstacimabTreatment of Hem A/Hem B 2024ARV-471ER+/HER2-BC2024TTI-622(PF801)Hematological malignancies2024Note:Expected timing;all dates are preliminary,subject to change,and subject to,among other risks,assumptions and unc

156、ertainties,clinical trial and regulatory success and availability of supply.1 In collaboration with BioNTech;and for COVID influenza combination,pending agreement between the partners.Additional Pipeline Potential Launches Through 2030 Selected Examples39Fourth Quarter 2022 Earnings2022 Financial Gu

157、idance vs.ResultsGuidanceResultsRevenues$99.5 to$102.0 billion$100.3 billionAdjusted1Cost of Sales as a Percentage of Revenues33.0%to 34.0%34.0%Adjusted1SI&A Expenses$12.8 to$13.3 billion$13.0 billionAdjusted1R&D Expenses$11.5 to$12.0 billion$11.4 billionAcquired IPR&D Expenses1Approximately$1.4 bil

158、lion$1.0 billionAdjusted1Other(Income)/DeductionsApproximately$1.8 billion of income$2.0 billion of incomeEffective Tax Rate on Adjusted1IncomeApproximately 12.5%11.7%Adjusted1Diluted EPS$6.40 to$6.50$6.58Met or Exceeded All Components of 2022 Total Company Financial Guidance1 See Slides 29-32for de

159、finitions and for additional information regarding Pfizers 2023 financial guidance.40Fourth Quarter 2022 EarningsBolstering the Pipeline with Recent Business Development OpportunitiesYearTherapeutic AreaOrganizationAsset/IndicationStatus Since Close2019BRAFTOVI&MEKTOVI Cancer;LMNA CardiomyopathyAppr

160、ovals:1;Pivotal Starts:2;FIH:31Cardiomyopathy discontinuedGTx Wilson DiseaseFast Track Designation(FDA);FIH:Dec 2022recifercept AchondroplasiaFailed Ph 2 interim analysis,discontinuedVupanorsen CV risk&severe hypertriglyceridemia2Discontinued and development rights returned to Ionis2020Vaccine Lyme

161、DiseasePh 2 readouts:6,Ph 3 starts:2,Fast Track designationVaccine modRNA Flu3Ph 3 Start:1Vaccine COVID-19Approvals:24;EUAs:15;Ph 3 readouts:14AV-006(ARX-1796)Drug-resistant Gram-negative infectionsPh 1Relugolix Prostate Cancer&Womens HealthApprovals:3;Submissions:2;Ph 3 Readouts:252021Fosmanogepix

162、Invasive fungal infectionsPh 2SPR206 Gram(-)infectionPh 1ER PROTAC Breast CancerPh 2(w.Ibrance);Ph 2(monotherapy dose expansion)TTI-622/621 OncologyPh 1b/2 new combination cohorts initiatedNurtec ODT/Vydura Migraine(outside the U.S.)6Approvals:5Myeloid DR-02 Platform Solid tumorsPre-clinicalEtrasimo

163、d GI(UC,Crohns focus)&Other Autoimmune DisordersPh 3 readouts:2;Submissions:3mRNA/Gene EditingPre-clinicalmRNA Program ShinglesPre-clinicalSelect Examples1.Approvals,pivotal starts and FIH apply to multiple assets acquired in Array agreement.2.Ionis fully acquired Akcea in August 2020.3.Transaction

164、executed in 2018.4.2 U.S.approvals for COVID-19 vaccine for 16+and 12-15 yrs.5.Approvals,submissions and Phase 3 readouts apply to Relugolix-Myfembree in Endometriosis.6.Pfizer completed acquisition of Biohaven Pharmaceuticals in October 2022.FIH=First in Human;GTx=Gene Therapy;CV=Cardiovascular;GI=

165、Gastrointestinal;UC=Ulcerative Colitis;modRNA=nucleoside-modified messenger RNA;EUA=Emergency Use AuthorizationOncology Internal MedicineHospitalRare Disease Vaccines Infla/ImmunWe also completed 4 transactions in China in 2020-21 with CStone(equity,development of future assets to be defined,co-prom

166、otion for NSCLC),LianBio(equity,future assets to be defined),CanSino(meningococcal vaccine),and Ferring(prostate cancer).41Fourth Quarter 2022 EarningsBolstering the Pipeline with Recent Business Development OpportunitiesYearTherapeutic AreaOrganizationAsset/IndicationStatus Since Close2022RSV antiv

167、iral therapeuticsSisunatovir(Ph2);RV299(N-protein inhibitor)(Ph 1)Nurtec ODT,zavegepant,5 pre-clinical CGRP assets Migraine(U.S.and global)Nurtec ODT(on market);zavegepant(PDUFA Q123)&addl Ph2 ongoingSickle Cell DiseaseOxbryta(on market,launched new 300 mg tablets for pediatrics);inclacumab Ph 3;GBT601 Ph 2(Dosing)Vaccine COVID-19/Influenza combinationPhase 1Select ExamplesOncology Internal MedicineHospitalRare Disease Vaccines Infla/ImmunCGRP=Calcitonin Gene-Related Peptide

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