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1、Merck Q4 2022 EarningsFebruary 2,2023Agenda2Strategy and Business UpdateRob DavisChairman and Chief Executive OfficerQuestion&Answer SessionBusiness/Financial Results and OutlookCaroline LitchfieldChief Financial OfficerResearch UpdateDr.Dean LiPresident,Merck Research LaboratoriesForward-looking st

2、atement of Merck&Co.,Inc.,Rahway,N.J.,USA3This presentation of Merck&Co.,Inc.,Rahway,N.J.,USA(the“company”)includes“forward-looking statements”within the meaning of the safe harbor provisions of the U.S.Private Securities Litigation Reform Act of 1995.These statements are based upon the current beli

3、efs and expectations of the companys management and are subject to significant risks and uncertainties.There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful.If underlyin

4、g assumptions prove inaccurate or risks or uncertainties materialize,actual results may differ materially from those set forth in the forward-looking statements.Risks and uncertainties include but are not limited to,general industry conditions and competition;general economic factors,including inter

5、est rate and currency exchange rate fluctuations;the impact of the global outbreak of novel coronavirus disease(COVID-19);the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally;global trends toward health care cost containment;technologi

6、cal advances,new products and patents attained by competitors;challenges inherent in new product development,including obtaining regulatory approval;the companys ability to accurately predict future market conditions;manufacturing difficulties or delays;financial instability of international economi

7、es and sovereign risk;dependence on the effectiveness of the companys patents and other protections for innovative products;and the exposure to litigation,including patent litigation,and/or regulatory actions.The company undertakes no obligation to publicly update any forward-looking statement,wheth

8、er as a result of new information,future events or otherwise.Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the companys Annual Report on Form 10-K for the year ended December 31,2021 and the companys other fili

9、ngs with the Securities and Exchange Commission(SEC)available at the SECs Internet site(www.sec.gov).Strategy&Business UpdateRob DavisChairman and Chief Executive OfficerDelivered on our key strategic priorities in 20225Achieved strong commercial and financial performanceAdvanced the pipeline to mee

10、t patient unmet needExecuted on strategic business development to enhance pipelineCreated long-term value for patients and shareholdersExceptional 2022 sales and underlying earnings growth161.Results from continuing operations attributable to Merck&Co.,Inc.2.Beginning in 2022,Merck no longer exclude

11、s expenses for upfront and milestone payments related to collaborations andlicensing agreements,or charges related to pre-approval assets obtained in transactions accounted for as asset acquisitions from its non-GAAP results.For 2020,non-GAAP results have been recast to include$4.2 billion of increm

12、ental R&D expenses,which reduced EPS by$1.56.For 2021,non-GAAP results have been recast to include$1.7 billion of incremental R&D expense,which reduced EPS by$0.65.For 2022,non-GAAP results include$690 million of R&D expense,or an estimated$0.22 of negative impact to EPS related to an asset acquisit

13、ion,and collaboration and licensing agreements.3.GAAP EPS of$1.18.$41.5B+6%$48.7B+17%GUIDANCE RANGE$57.5B-$58.5B$13.8B+2%4Q Worldwide Sales$1.62-10%4Q Non-GAAP EPS2,3202020212022$41.5B+6%$48.7B+17%202020212022$2.97$5.37Full Year RevenueFull Year Non-GAAP EPS2$59.3B+22%$7.48Advancing and augmenting p

14、ipeline across multiple therapeutic areas in Q47OncologyCardiovascularMerck to present data for sotatercept and MK-0616,oral macrocyclic peptide PCSK9 inhibitor,at ACC.23/WCCMerck to host investor event on March 6thto discuss these resultsAnnounced positive top line results for the Phase 2 trial eva

15、luating KEYTRUDA in combination with mRNA-4157/V940,an investigational personalized mRNA therapeutic cancer vaccine in adjuvant treatment of patients with stage III/IV melanoma following complete resectionReceived FDA approval for KEYTRUDA for the adjuvant treatment of adult patients with stage IB(T

16、2a=4 cm),II or IIIA non-small cell lung cancer following resection and platinum-based chemotherapy based on KN-091VaccinesMerck collaborator Instituto Butantan(IB)announced positive topline results from IBs Phase 3 dengue vaccine candidate.Results to inform next steps for V181 program1Business Devel

17、opmentAugmented pipeline with new candidates from recent business development transactions,including:oCollaborations with Moderna and Kelun-BiotechoAcquisition of ImagoIn 2023,expect four Phase 3 trial starts from programs added in 2022 through business development1.Both Merck and IBs investigationa

18、l vaccines are derived from materials licensed from the U.S.National Institutes of Health and both institutions are evaluating formulations analogous to the NIH TV003 formulation.Enhance durable growth driversDeploy cash flow to value-enhancing BDLeverage leadership in oncologyAdvance pipeline acros

19、s key therapeutic areasBuilding a sustainable engine to drive success into the next decade8New combinations and coformulationsNew delivery mechanismsNew mechanisms of action outside of immuno-oncologyCardiometabolicVaccinesNeuroscienceInfectious Disease/ImmunologyAdditional immuno-oncology approache

20、sAmple balance sheet capacityDisciplined approachPursuing the best external scienceVaccinesAnimal HealthBusiness/Financial Results and OutlookCaroline LitchfieldChief Financial OfficerMerck achieved exceptional 2022 financial performance110WORLDWIDE SALES2$59.3B+22%growth+26%ex-exchange+15%ex-exchan

21、ge,LAGEVRIO4NON-GAAP EPS33,5$7.48+39%growth+43%ex-exchangeMerck1.Results from continuing operations attributable to Merck&Co.,Inc.2.Worldwide Sales includes Other Revenue;3.Merck is providing certain 2022 and 2021 non-GAAP information that excludes certain items because of the nature of these items

22、and the impact they have on the analysis of underlying business performance and trends.Management believes that providing this information enhances investors understanding of the companys results because management uses non-GAAP results to assess performance.Management uses non-GAAP measures interna

23、lly for planning and forecasting purposes and to measure the performance of the company along with other metrics.In addition,senior managements annual compensation is derived in part using a non-GAAP pre-tax income metric.This information should be considered in addition to,but not as a substitute f

24、or or superior to,information prepared in accordance with GAAP.For a description of the non-GAAP adjustments,see Table 2a attached to the press release.Non-GAAP results for 2021 have been recast to conform to presentation changes implemented in 2022.4.Excludes impact of foreign exchange and LAGEVRIO

25、 sales of$5.7B.4.GAAP EPS of$5.71.Strong Q4 performance across Human Health and Animal Health11MerckWORLDWIDE SALES1,2$13.8B+2%growth+8%ex-exchange$12.2B+1%growth+9%ex-exchangeHuman Health$1.2B-2%growth+6%ex-exchangeAnimal Health1.Results from continuing operations attributable to Merck&Co.,Inc.2.Wo

26、rldwide Sales includes Other RevenueOncology:KEYTRUDA drives continued growth12Growth rates exclude the impact of foreign exchange.KEYTRUDA sales of$5.5B increased 26%year-over-year,driven by strong global demand and expansion into new indications In the U.S.,growth of 27%reflects strong growth acro

27、ss all key tumor types,especially in earlier-stage cancers such as high-risk,early-stage TNBC Expect to launch earlier stage NSCLC indication based on recent FDA approval of KEYNOTE-091 study Ex-U.S.,24%increase driven by continued global uptake in metastatic indications,such as NSCLC,H&N and RCC St

28、rong uptake from recent launches in high-risk,early-stage TNBC and RCC$4.2B+20%$3.4B+31%$5.3B+30%4Q204Q214Q22$4.6B+16%$4.0B+27%$5.5B+26%Oncology:Robust performance across broad portfolio Lynparza1sales increased 14%,with growth driven by continued demand in adjuvant treatment of certain patients wit

29、h gBRCAm,HER2-negative high-risk early-stage breast cancer Lenvima2sales grew 9%driven by increased uptake in advanced RCC and advanced endometrial cancer in the U.S.WELIREG continues to perform in line with expectations providing a treatment option for patients with certain VHL-associated tumors$24

30、8M+34%$178M+62%$275M+17%$181M+15%$151M+57%$231M+33%13Growth rates exclude the impact of foreign exchange.1 In collaboration with AstraZeneca;2 In collaboration with Eisai4Q204Q214Q224Q204Q214Q22$268M+33%$206M+53%$292M+14%$206M+31%$158M+26%$216M+9%Vaccines:Gardasil growth driven by strong global dema

31、nd 14 GARDASIL sales of$1.5B increased 6%year-over-yearprimarily driven by strong underlying demand outside the U.S.Ex-U.S.,reflects demand driven growth,particularly in China U.S.sales declined primarily due to CDC purchasing patterns Pediatric launch of VAXNEUVANCE off to an encouraging start;sale

32、s benefitted from inventory stocking$1.2B+78%$656M-24%$1.7B+40%4Q204Q214Q22$1.5B+50%$998M+41%$1.5B+6%Growth rates exclude the impact of foreign exchange.Hospital:Strong global demand across key products15 BRIDION sales of$441M increased 7%primarily due to greater share among neuromuscular blockade r

33、eversal agents and increase in surgical procedures PREVYMIS sales grew 28%,driven by continued strong global demand ZERBAXA benefited from completion of global resupply which started in Q4 2021$387M+67%$224M-18%$426M+15%4Q204Q214Q22$436M+24%$355M+13%$441M+7%$93M+41%$63M+67%$103M+18%4Q204Q214Q22$100M

34、+27%$80M+57%$118M+28%Growth rates exclude the impact of foreign exchange.Animal Health:Solid growth driven by livestock16 Animal Health sales increased 6%to$1.2B,reflecting strategic price actions and volume growth Livestock sales grew 12%due to increased demand in ruminants and poultry products Com

35、panion Animal sales decreased 5%due to supply challenges for certain vaccines and a reduction in vet visits in October,which improved during the quarter$1.5B+27%$1.1B+3%$1.5B+5%4Q204Q214Q22$1.3B+8%$1.2B+6%$1.2B+6%Growth rates exclude the impact of foreign exchange.Q4 2022 continuing operations non-G

36、AAP financial results summary1Q4 2022Q4 2021ChangeChange Ex-FXSales$13.8$13.5+2%+8%Non-GAAP Gross Margin75.7%74.8%+0.9pts+0.3ptsNon-GAAP Operating Expenses2$5.7$5.3+8%+12%Non-GAAP Tax Rate15.6%4.3%+11.3ptsN/ANon-GAAP EPS3$1.62$1.81-10%-7%$in billions,except EPS amounts171.Merck is providing certain

37、2022 and 2021 non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends.Management believes that providing this information enhances investors understanding of the companys results beca

38、use management uses non-GAAP results to assess performance.Management uses non-GAAP measures internally for planning and forecasting purposes and to measure the performance of the company along with other metrics.In addition,senior managements annual compensation is derived in part using a non-GAAP

39、pre-tax income metric.This information should be considered in addition to,but not as a substitute for or superior to,information prepared in accordance with GAAP.For a description of the non-GAAP adjustments,see Table 2a attached to the press release.Non-GAAP results for 2021 have been recast to co

40、nform to presentation changes implemented in 2022.2.Non-GAAP results include$690 million of R&D expense,or an estimated$0.22 of negative impact to EPS,related to an asset acquisition,and collaboration and licensing agreements 3.Q4 2022 GAAP EPS of$1.18.Merck provides full-year 2023 guidance1.GAAP Gr

41、oss Margin Rate:73%.2.GAAP Operating Expenses:$23.3 to$24.3 billion.3.GAAP Tax Rate:17-18%4.The GAAP to non-GAAP reconciliation is available in Mercks Q4 2022 earnings release 5.Merck does not exclude expenses for upfront and milestone payments related to collaborations and licensing agreements,as w

42、ell as charges related to pre-approval assets obtained in transactions accounted for as asset acquisitions from its non-GAAP results.GuidanceKey AssumptionsRevenue$57.2B to$58.7B-4%to-1%(-2%to+1%ex-FX)Includes approximately$1B of LAGEVRIO revenueEx-LAGEVRIO,growth of 5%to 8%(7 to 10%ex-FX)Assumes 2%

43、FX headwindNon-GAAP Gross Margin Rate177.0%Non-GAAP Operating Expenses2$23.1B to$24.1BIncludes$1.4B of upfront R&D expense related to acquisition of Imago Biosciences and expansion of collaboration with Kelun BiotechOther(Income)/Expense$250M of incomeAssumes no pension settlement cost as well as an

44、 expectation of higher interest income and higher joint venture equity incomeTax Rate317.0%-18.0%Assumes unfavorable impact due to the R&D capitalization provision,as well as 1%unfavorable impact related to ImagoShares Outstanding2.55BGAAP EPS$5.86 to$6.01Non-GAAP EPS4,5$6.80 to$6.95Reflects upfront

45、 R&D expense$0.53 for Imago Biosciences and KelunBiotechAssumes 4%FX headwind 18Key modeling considerations for 202319Other Revenue Expect strong growth driven by robust global demand,particularly in ex-U.S.markets Increased ability to supply positions us well to support significant demand now and i

46、n the future Expect significant decline,resulting from smaller planned benefit from revenue hedges following U.S.dollar strength in 2022 o Resulted in an$800M benefit in 2022 Reflects discontinuation of third-party manufacturing sales to Johnson and JohnsonGARDASILOther(Income)/Expense and Tax Rate

47、Other Income assumes no pension settlement cost;expect higher interest income and joint venture equity income Tax Rate assumes unfavorable impact of R&D capitalization provision and approximate 1 ppt unfavorable impact related to the Imago transaction20Continue to prioritize investments in ourpipeli

48、ne and businessto realize value of near-and long-term opportunities$2.6$1.1$1.7$0.3$0.0 After-Tax R&DCapExDividendsPaidBusiness Development(ex-divestitures)Share Repurchase$Billions11.Reflects Q4 spend Remain committed to balanced capital allocation strategyCapital allocation order of priorityResear

49、ch UpdateDr.Dean LiPresident,Merck Research Laboratories22Working to help transform the landscape of cancer treatment by focusing on earlier stages of diseaseAdvancing our collaboration with Moderna to leverage mRNA technology with KEYTRUDA to target the unique mutational signature of each patients

50、tumor in melanoma and other tumor typesKEYTRUDAImmunotherapy that increases the ability of the bodys immune system to help detect and fight tumor cellsmRNA-4157/V940 Designed to stimulate an immune response by generating specific T cell responses based on the unique mutational signature of a patient

51、s tumorMaking progress in the treatment of earlier stage non-small cell lung cancer through various clinical trials APPROVEDPHASE III KEYNOTE-091:Received FDA approval for KEYTRUDA for adjuvant treatment of adult patients with stage IB(T2a=4 cm),II or IIIA NSCLC following resection and platinum-base

52、d chemotherapy KEYNOTE-671:Evaluating KEYTRUDA with platinum doublet chemotherapy as neoadjuvant followed by adjuvant therapy for patients with resectable stage II,IIIA and IIIB NSCLC KEYNOTE-867:Evaluating KEYTRUDA in patients undergoing stereotactic body radiotherapy with unresected stage I or II

53、NSCLC KEYLYNK-012:Evaluating KEYTRUDA in combination with Lynparza1in stage III disease1 In collaboration with AstraZeneca23Advancing our broader oncology portfolioHematologyTissue Targeting TherapiesEx-U.S.ApprovalsPositive Data Readouts In Europe:Received approval for Lynparza1in combination with

54、abiraterone and prednisone or prednisolone for the treatment of certain patients with mCRPC based on PROpel In China:Received approval for KEYTRUDA in neoadjuvant/adjuvant high-risk,early-stage TNBC based on KN-522 Received approval for KEYTRUDA in hepatocellular carcinoma based on KN-394 Announced

55、acquisition of Imago Biosciences:Lead candidate bomedemstat a potentially first-in-class orally available lysine-specific demethylase 1 inhibitor(LSD-1)Presented data at American Society of Hematology Meeting for:favezelimab(anti-LAG3)zilovertamab vedotin(ROR-1)nemtabrutinib(BTKi)KEYTRUDA Padcev2:FD

56、A accepted sBLAfor Keytruda to be used in combination with Padcev,an ADC targeting Nectin-4,for 1L treatment of certain patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy Kelun-Biotech:Expanded collaboration with up to 7 additional

57、 preclinical antibody drug conjugate candidates PeptiDream:Expanded ongoing collaboration for the discovery and development of peptide drug conjugates KEYNOTE-966:Announced positive Phase III results evaluating KEYTRUDA in combination with chemotherapy in 1L treatment of advanced or unresectable bil

58、iary tract cancer KEYNOTE-859:Announced positive Phase III results evaluating KEYTRUDA in combination with chemotherapy in HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma1.In collaboration with Astra Zeneca 2.In collaboration with Astella

59、s and Seagen.Padcev is a registered trademark of Seagen and Agensys.24Focusing on important unmet medical needs through vaccine development programs Receiving positive feedback from physicians followinglaunch of VAXNEUVANCE in the pediatric setting VAXNEUVANCE offers strong immunogenicity,including

60、in the first year of life where incidence of IPD is greatest within the healthy pediatric populationPneumococcal Disease ChartCenters for Disease Control and Prevention,IPD serotype data 2019,as compiled from data provided through Active Bacterial Core surveillance(ABCs).Active Bacterial Core Survei

61、llance(ABCs)report emerging infections program network streptococcus pneumoniae,2019.Available:SPN Surveillance Report 2019.pdf(cdc.gov).Source:Epidemiology of pneumococcal disease and pneumococcal vaccine coverage in US children,Ryan Gierke,MPH.Advisory Committee on Immunization Practices,February

62、24th,2022.Collaborating with Instituto Butantan(IB)to conduct a detailed analysis of IBs positive Phase 3 data in order to determine further clinical development of Mercks vaccine candidate,V181V181 is being investigated to help provide,in a single dose,protection against all four dengue serotypes r

63、egardless of prior exposure to dengueDengueInvasive Pneumococcal Disease25Recent data published on cancer incidenceAmong women ages 20 to 24,cervical cancer incidence rates declined by a total of 65%from 2012 through 2019.1 We,along with others in the industry,are making a real impact in our goal to

64、 help reduce cancer incidence American Cancer Society published its annual report on cancer facts and trends Reinforces our commitment to bringing forward treatment and prevention options to help patients-American Cancer SocietyCervical Cancer1.Cancer statistics,2023,Rebecca L.Siegel,CA Cancer J Cli

65、n.2023;73:174826Significant advancements across our broader pipeline and portfolioGranted conditional marketing authorization for LAGEVRIO by Chinas National Medical Products AdministrationUnder Emergency Use Authorization,LAGEVRIO remains an important treatment option as the COVID-19 pandemic conti

66、nues to evolveCOVID-19Cardiovascular At ACC.23/WCC on March 6th,Merck to:Present results from Phase 3 STELLAR study evaluating sotatercept for treatment of pulmonary arterial hypertension Present data from Phase 2 study evaluating MK-0616,oral macrocyclic peptide PCSK9 inhibitor,for treatment of hyp

67、ercholesterolemiaHost live investor eventStrong progress across our pipeline throughout 2022271.Both Merck and IBs investigational vaccines are derived from materials licensed from the U.S.National Institutes of Health and both institutions are evaluating formulations analogous to the NIH TV003 form

68、ulation.2.nucleoside reverse transcriptase translocation inhibitor VAXNEUVANCE:Received approval in the pediatric setting V116:Received Breakthrough Therapy Designation and advanced into Phase 3 trials for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults V181:Merc

69、k collaborator Instituto Butantan(IB)announced positive topline results from IBs Phase 3 dengue vaccine candidate.Results to inform next steps for V181 program1CardiometabolicInfectious DiseaseVaccines Sotatercept:Announced positive topline results for Phase 3 STELLAR trial in PAH MK-0616:Completed

70、Phase 2 trial in patients with hypercholesterolemia MK-2060:Received Fast Track designation for the reduction in risk of major thrombotic cardiovascular events in patients with ESRD MK-5475:Initiated Phase 2 study in patients with PH-COPD Islatravir:Reinitiated development program in the HIV treatme

71、nt setting MK-8527:Initiated Phase 1b study of internal novel NRTTI2for HIV PrEP LAGEVRIO:Initiated Phase 2 trial for the treatment of RSVOncology KEYTRUDA:Received approval for advanced endometrial cancer that is MSI-H or dMMR(KN-158)Received approval for KN-091 for adjuvant treatment of adult pati

72、ents with stage IB(T2a=4cm),II or IIIA NSCLC following resection and platinum-based chemotherapy Announced positive topline results for HER2-locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma(KN-859)Lynparza:Received approval for adjuvant treatment of adults with gBRCAm,HER2-h

73、igh-risk early breast cancer(OlympiA)MRNA-4157/V940:Announced positive topline results for Phase 2b trial in adjuvant treatment in patients with stage III/IV melanoma following complete resectionQ&ARob DavisChairman&Chief Executive OfficerCaroline LitchfieldChief Financial OfficerDr.Dean LiPresident

74、,Merck Research LaboratoriesPeter DannenbaumVice President,Investor RelationsAppendix29$404$580$704$8762019202020212022$444$725$989$1,1162019202020212022$11,084$14,380$17,186$20,9372019202020212022Sustained strong full-year performance across key growth pillarsAll growth rates exclude the impact of

75、foreign exchange.$In millions.Lynparza in collaboration with AstraZeneca.Lenvima in collaboration with Eisai.$1,131$1,198$1,532$1,6852019202020212022$3,737$3,938$5,673$6,8972019202020212022$4,393$4,703$5,568$5,5502019202020212022+6%YOY+27%YOY+16%YOY+28%YOY+18%YOY+27%YOY30Q4 2022 continuing operation

76、s GAAP financial results summary31Q4 2022Q4 2021ChangeChange Ex-FXSales$13.8$13.5+2%+8%Operating Expenses$6.5$5.9+10%+13%Tax Rate14.1%2.2%+11.9ptsN/AGAAP EPS$1.18$1.51-22%-17%$in billions,except EPS amounts2022 continuing operations GAAP financial results summary:3220222021ChangeChange Ex-FXSales$59

77、.3$48.7+22%+26%Operating Expenses$23.6$21.9+8%+11%Tax Rate11.7%11.0%+0.7ptsN/AGAAP EPS$5.71$4.86+17%+21%$in billions,except EPS amounts2022 continuing operations non-GAAP financial results summary:Delivered strong revenue and EPS growth20222021ChangeChange Ex-FXSales$59.3$48.7+22%+26%Non-GAAP Gross

78、Margin174.4%76.1%-1.7pts-2.1ptsOperating Expenses$21.6$21.0+3%+6%Tax Rate14.2%12.4%+1.8ptsN/ANon-GAAP EPS that excludes certain items1$7.48$5.37+39%+43%$in billions,except EPS amounts331.Merck is providing certain 2022 and 2021 non-GAAP information that excludes certain items because of the nature o

79、f these items and the impact they have on the analysis of underlying business performance and trends.Management believes that providing this information enhances investors understanding of the companys results and permits investors to understand how management assesses performance.Management uses th

80、ese measures internally for planning and forecasting purposes and to measure the performance of the company along with other metrics.In addition,senior managements annual compensation is derived in part using non-GAAP pretax income.This information should be considered in addition to,but not as a su

81、bstitute for or superior to,information prepared in accordance with GAAP.$10.2$4.4$7.0$2.4$0.0$0$3$6$9$12$15After-Tax R&DCapExDividends PaidBusiness Development(ex-divestitures)Share RepurchaseCapital allocation:Trailing twelve months$18B Over 5 years,including expanding manufacturing capacity for O

82、ncology,Vaccines,and Animal Health.Includes$10B in the U.S.Billions$1.76$1.80$1.84$1.88$1.92$2.20$2.44$2.60$2.76$2.92$1.40$1.70$2.00$2.30$2.60$2.90$3.202014201520162017201820192020202120222023Dollars per share+2%+2%+2%+2%+2%+11%+15%+7%Over the past 12 monthsCapital investments2022 to 2026Commitment

83、to the dividend34Well positioned balance sheet with capacity to fund additional value-enhancing business developmentopportunities+6%Order of priority+6%E1.Includes payments reflected in operating cash flow1Driving value for patients and shareholders by progressing our pipeline35Key regulatory milest

84、ones since the last earnings call:Key data&clinical advancementssince the last earnings call:In the U.S.:o The FDA granted approval of KEYTRUDA following surgical resection and platinum-based chemotherapy in patients with stage IB,II or IIIA non-small cell lung cancer based on KN-091,as well as acce

85、pted submission of Supplemental Biologics License Applications for PADCEV1+KEYTRUDA to be used in combination as 1L treatment of certain patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy based on KN-869In Europe:o Received approva

86、l for Lynparza2in combination with abiraterone and prednisone or prednisolone in certain patients with metastatic castration-resistant prostate cancer based on PROpelIn China:o Received approval for KEYTRUDA in patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant

87、treatment based on KN-522,as well as conditional marketing authorization for LAGEVRIO in adult patients with mild to medium COVID-19 infection and a high risk of progressing to severe casesIn Japan:o Completed submission of KN-170/KN-A33 in patients with relapsed or refractory primary mediastinal la

88、rge B-cell lymphoma1.In collaboration with Astellas and Seagen.Padcevis a registered trademark of Seagenand Agensys.2.In collaboration with AstraZeneca.Announced with partner Moderna,positive topline results from Phase 2b KN-942 trial evaluating mRNA-4157/V940,an investigational personalized mRNA ca

89、ncer vaccine in combination With KEYTRUDAAnnounced positive topline results from Phase 3 KN-859 trial evaluating KEYTRUDA in combination with chemotherapy for 1L treatmentin patients with HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction(GEJ)adenocarcinom

90、aPresented data across broad hematology pipeline and portfolio at ASH,including for favezelimab(MK-4280),zilovertamabvedotin(MK-2140),nemtabrutinib(MK-1026)and KEYTRUDA Announced publication of updated systematic literature review examining the global impact and effectiveness of GARDASIL across 138

91、studies Initiated Phase 3 studies for MK-1026 in hematologic malignanciesPhase 2Phase 3Under regulatory reviewOncologyV181Dengue Fever VirusVaccinesInfectious diseasesMK-81894SchizophreniaNeuroscienceGefapixant(MK-7264)Cough(US,EU)General medicineGeneral medicineAs of February 1,2023V114Pneumococcal

92、 Vaccine,pediatric(JPN)VaccinesInfectious diseasesOncologyOncologyMK-1942Treatment Resistant DepressionMK-3655NASHMK-6024(efinopegdutide)NASHMK-7075(miransertib)Overgrowth SyndromeMK-8591B(islatravir+MK-8507)1HIV-1 InfectionMK-8591D(islatravir+lenacapavir)2HIV-1 InfectionKEYTRUDA(MK-3475)Biliary Tra

93、ctCSCC(EU)Gastric(EU)Hepatocellular(EU)MesotheliomaOvarianProstateSCLCMK-1308A(quavonlimab+pembrolizumab)RCCMK-7684A(vibostolimab+pembrolizumab)MelanomaNSCLCSCLCMK-4280A(favezelimab+pembrolizumab)CRCHematological MalignanciesLENVIMA(MK-7902)CRCEsophagealGastricHNSCCMelanomaNSCLCLYNPARZA(MK-7339)NSCL

94、CSCLCWELIREG(MK-6482)RCCTUKYSA(MK-7119)BreastCRCMK-3475(pembrolizumab subcutaneous)NSCLCMK-8591A(doravirine+islatravir)2HIV-1 InfectionLAGEVRIO(MK-4482)3COVID-19 antiviralKEYTRUDA(MK-3475)1L Urothelial(US)2L HCC(US)LA Merkel Cell(US)Adjuvant NSCLC(EU)B-Cell Lymphoma(JPN)LYNPARZA(MK-7339)Metastatic 1

95、L Prostate(US,JPN)MK-0616HypercholesterolemiaMK-2060ThrombosisMK-5475Pulmonary Arterial HypertensionMK-7962(sotatercept)Pulmonary Hypertension due to Left Heart DiseaseCardiovascularMK-4830CRC EsophagealMelanomaNSCLCOvarianRCCSCLCMK-5684ProstateMK-5890(boserolimab)NSCLCSCLCMK-6440(ladiratuzumabvedot

96、in)BreastEsophagealGastricHNSCCMelanomaNSCLCProstateSCLCMK-2870Neoplasm MalignantKEYTRUDA(MK-3475)Advanced Solid TumorsMK-3543(bomedemstat)Myeloproliferative DisordersMK-4280(favezelimab)NSCLCMK-4280A(favezelimab+pembrolizumab)Esophageal MelanomaRCCSCLCWELIREG(MK-6482)BiliaryCertain VHL tumors(EU)CR

97、CEndometrialEsophagealHCCPancreaticRare CancersLYNPARZA(MK-7339)Advanced Solid TumorsLENVIMA(MK-7902)BiliaryPancreasProstateSCLCmRNA-4157/V940Melanoma MK-7684A(vibostolimab+pembrolizumab)BiliaryBladderBreastCervicalCRCEndometrialEsophagealGastricHCCHNSCCHematological MalignanciesOvarianProstateTUKYS

98、A(MK-7119)Advanced Solid TumorsBladderBiliaryCervicalEndometrialGastricNSCLCMK-0482NSCLCMK-1026(nemtabrutinib)Hematological MalignanciesMK-1308(quavonlimab)NSCLCMK-1308A(quavonlimab+pembrolizumab)CRCHCCMelanomaSCLCMK-2140(zilovertamabvedotin)BladderBreastGastricHematological MalignanciesNSCLCOvarian

99、PancreasBroad and innovative pipeline to solve significant unmet medical needs36VaccinesMK-1654(clesrovimab)Respiratory Syncytial Virus(RSV)1On FDA clinical hold 2On FDA partial clinical hold for higher doses than those used in current clinical trials3Available in the US under EUA 4Development is co-funded by Royalty PharmaMK-7962(sotatercept)Pulmonary Arterial HypertensionCardiovascularInfectious diseasesLAGEVRIO(MK-4482)COVID-19 antiviral(EU)V116Pneumococcal vaccine,adult