MRK-JP-Morgan-Healthcare-Conference-Presentation-FINAL MSD.pdf

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1、JP Morgan Healthcare ConferenceJanuary 9,2023Strategy and Business UpdateRob DavisChairman and Chief Executive OfficerForward-looking statement 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

2、 the safe harbor provisions of the U.S.Private Securities Litigation Reform Act of 1995.These statements are based upon the current beliefs and expectations of the companys management and are subject to significant risks and uncertainties.There can be no guarantees with respect to pipeline candidate

3、s that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful.If underlying assumptions prove inaccurate or risks or uncertainties materialize,actual results may differ materially from those set forth in the forward-looking statements.Ris

4、ks and uncertainties include but are not limited to,general industry conditions and competition;general economic factors,including interest rate and currency exchange rate fluctuations;the impact of the global outbreak of novel coronavirus disease(COVID-19);the impact of pharmaceutical industry regu

5、lation and health care legislation in the United States and internationally;global trends toward health care cost containment;technological advances,new products and patents attained by competitors;challenges inherent in new product development,including obtaining regulatory approval;the companys ab

6、ility to accurately predict future market conditions;manufacturing difficulties or delays;financial instability of international economies and sovereign risk;dependence on the effectiveness of the companys patents and other protections for innovative products;and the exposure to litigation,including

7、 patent litigation,and/or regulatory actions.The company undertakes no obligation to publicly update any forward-looking statement,whether 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-lo

8、oking statements can be found in the companys Annual Report on Form 10-K for the year ended December 31,2021 and the companys other filings with the Securities and Exchange Commission(SEC)available at the SECs Internet site(www.sec.gov).Significant advancements across key strategic priorities4Advanc

9、ing The pipeline to meet patient unmet needsAchievingStrong commercial and financial performanceExecuting Strategic business development to enhance pipelineCreatingLong-term value for patients and shareholdersStrong commercial and operational execution driving revenue and EPS growth5Growth rates inc

10、lude the impact of foreign exchange.For 2020,non-GAAP results have been recast to include$4.2 billion of incremental R&D expenses,which reduced previously reported non-GAAP EPS by$1.56.For 2021,non-GAAP results have been recast to include$1.7 billion of incremental R&D expense,which reduced previous

11、ly reported non-GAAP EPS by$0.65.For 3Q 2022,Non-GAAP results include$690 million of R&D expense for collaborations and licensing agreements with Moderna,Orna and Orion,or an estimated$0.22 of negative impact to EPS.Excellent commercial execution across key growth pillars:Oncology Vaccines Hospital

12、Animal HealthStrong underlying growth excluding LAGEVRIORevenueNon-GAAP EPS20202021Full year3Q 2021 3Q 2022YTD$48.7B+17%$45.5B+29%$41.5B$35.2B20202021Full year3Q 2021 3Q 2022YTD$5.37+81%$5.86+65%$2.97$3.56+15%ex-LAGEVRIO$660$404$580$704201920202021YTD 3Q 2022$825$444$725$989201920202021YTD 3Q 2022$1

13、5,487$11,084$14,380$17,186201920202021YTD 3Q 2022Sustained strong performance across key growth pillarsAll growth rates exclude the impact of foreign exchange.All growth rates represent 3Q YTD growth.$In millions.Lynparza in collaboration with AstraZeneca.Lenvima in collaboration with Eisai.Full yea

14、rThrough 3Q$1,244$1,131$1,198$1,532201920202021YTD 3Q 2022$5,428$3,737$3,938$5,673201920202021YTD 3Q 2022$4,320$4,393$4,703$5,568201920202021YTD 3Q 2022+6%YOY+35%YOY+19%YOY+36%YOY+20%YOY+28%YOY6Enhance durable growth driversDeploy cash flow to value-enhancing BDLeverage leadership in oncologyAdvance

15、 pipeline across key therapeutic areasAdvancing key levers to drive success into the next decade7New combinations and coformulationsNew delivery mechanismsNew mechanisms of action outside of immuno-oncologyCardiometabolicVaccinesNeuroscienceInfectious Disease/ImmunologyAdditional immuno-oncology app

16、roachesAmple balance sheet capacityDisciplined approachPursuing the best external scienceVaccinesAnimal HealthDurable growth drivers provide a strong foundation8Vaccines GARDASIL sales expected to double off a 2021 base by 2030,driven by strong global demand and increased ability to supply Potential

17、 suite of population-specific pneumococcal conjugate vaccines addressing large and growing market Established presence in pediatric vaccines Promising pipeline in RSV and DengueAnimal Health Broad global portfolio to continue to deliver abovemarket growth Innovative pipeline across both Companion An

18、imaland Livestock Promising monitoring technology with potential to expand livestock offerings and advance pet healthGrowth rates excluding the impact of foreign exchange.Sustained results driven by robust underlying demand and strong commercial executionVaccinesAnimal Health3Q203Q213Q22Year to date

19、3Q203Q213Q22Year to date$7.4B+18%$6.1B-5%$8.7B+21%$4.3B+19%$4.3B+6%$3.5B+12%Prioritizing strategic business development to augment the pipeline9Results from continuing operations attributable to Merck&Co.,Inc2022+not actuals;2022 values reflect the midpoint of guidance.Beginning in 2022,Merck no lon

20、ger excludes expenses for upfront and milestone payments related to collaborations and licensing agreements,or charges related to pre-approval assets obtained in transactions accounted for as asset acquisitions from its non-GAAP resultsDelivering visible de-risked revenue growth and operating margin

21、s of 43%by 2025Revenue$in billionsNon-GAAPOperating marginDisciplined approachPursuing opportunities that will create sustainable valuefor shareholders Ample balance sheet capacityFinancial flexibility to evaluate the full breadth of the business development landscapeStrategic prioritySeeking the be

22、st external science to augment the pipeline,unbounded by therapeutic area$0$20$40$60$8020202021202220250%10%20%30%40%50%2020202120222025Enhanced pipeline with important business development in 202210Collaboration to develop circular RNA technology in multiple areas,including infectious diseases and

23、oncologyCollaboration on ODM-208(CYP11A1 inhibitor)complements strategy in prostate cancerCollaboration to evaluate mRNA-4157/V940(personalized cancer vaccine)in multiple tumor typesAnnounced acquisition expected to expand hematology presence with bomedemstat(LSD1 inhibitor)Advanced collaboration to

24、 develop SKB-264(TROP2 ADC)and 7 investigational preclinical ADCsAcquisition complements broad Animal Health portfolio with virtual fencing technology$36.5B on BD over the last 5 years1Collaboration for the discovery and development of novel peptide drug conjugates 1.Includes bolt-on acquisitions,st

25、rategic collaborations&licensing,and milestone paymentsResearch UpdateDr.Dean LiPresident,Merck Research LaboratoriesSignificant pipeline advancements across therapeutic areas in 202212 VAXNEUVANCE:Received approval in the pediatric setting V116:Received Breakthrough Therapy Designation and advanced

26、 into Phase 3 trials for the prevention of invasive pneumococcal disease in adults V181:Merck collaborator Instituto Butantan(IB)announced positive topline results from IBs Phase 3 dengue vaccine candidate.Results to inform next steps for V181 program1CardiometabolicInfectious DiseaseVaccines Sotate

27、rcept:Announced positive topline data for Phase 3 STELLAR trial in PAH MK-0616:Completed 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 stu

28、dy in patients with PH-COPD Islatravir:Reinitiated development program in the HIV treatment setting MK-8527:Initiated Phase 1b study of internal novel NRTTI for HIV PrEP LAGEVRIO:Initiated Phase 2 trial for the treatment of RSVOncology KEYTRUDA:Received approval for advanced endometrial cancer that

29、is MSI-H or dMMR(KN-158)FDA accepted for review KN-091 for the adjuvant treatment of patients with stage IB,II or IIIA NSCLC Announced positive topline results for HER2-gastric or GEJ adenocarcinoma(KN-859)Lynparza:Received approval for adjuvant treatment of adults with gBRCAm,HER2-high-risk early b

30、reast cancer(OlympiA)MRNA-4157/V940:Announced positive topline data for Phase 2b trial in adjuvant melanoma1.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 N

31、IH TV003 formulation.Leveraging leadership in oncology with robust portfolioand innovative pipeline13Further establish KEYTRUDA as a foundational anti-PD-1 cancer treatment in monotherapy and in combination regimensDiversify through collaborations with PARPi,VEGF TKI,HER2 TKI,LIV-1 ADC,TROP-2 ADC,CY

32、P11A1,personalized cancer vaccineDiversify through acquisitions of LSD1,BTK,HIF-2,ROR-1 ADC assetsExpand the IO-IO strategy through combinations with internal assetsExpand into cell-based therapies&T/NK cell engagersHIF-2Nemtabrutinib(MK-1026)rBTKiZilovertamab Vedotin(MK-2140)anti-ROR-1 ADCBomedemst

33、at1LSD1i1.Transaction expected to close in 1Q 2023anti-ILT-3(MK-0482)Vibostolimab/pembro(MK-7684A)anti-TIGITQuavonlimab/pembro(MK-1308A)anti-CTLA-4Favezelimab/pembro(MK-4280A)anti-LAG-3anti-ILT-4(MK-4830)LadiratuzumabVedotin(LV)MRNA-4157/V940SKB-264ODM-208Collaboration with Moderna to leverage exper

34、tise in mRNA and immuno-oncology to improve outcomes for patients with cancer14Combining mRNA-4157/V940 with KEYTRUDA may provide a synergistic effect and enhance T cell-mediated destruction of tumor cellsDevelopment strategy To discuss Phase 2b results with regulatory authorities and initiate a Pha

35、se 3 study in melanoma in 2023 Planning additional studies in other forms of cancerPositive Phase 2b results Phase 2 trial for the adjuvant treatment of patients with stage III/IV melanoma with high risk of recurrence following complete resection Demonstrated a statistically significant and clinical

36、ly meaningful improvement in RFS versus KEYTRUDA alone Combination reduced the risk of recurrence or death by 44%(HR=0.56 95%CI,0.31-1.08;one-sided p-value=0.0266)KEYTRUDAImmunotherapy that increases the ability of the bodys immune system to help detect and fight tumor cellsmRNA-4157/V940 Designed t

37、o stimulate an immune response by generating specific T cell responses based on the unique mutational signature of a patients tumorBroad pipeline advancing across key therapeutic areas15VaccinesPAHsotatercept(ligand trap,Phase 3)Chronic Heart Failure(without worsening event)Verquvo(sGC stimulator,Ph

38、ase 3)PAHMK-5475(Inhaled sGC stimulator,Phase 2/3)Lipid LoweringMK-0616(Oral PCSK9 inhibitor,Phase 2)ThrombosisMK-2060(Factor XI inhibitor,Phase 2)NASHMK-6024(GLP-1/glucagon receptor dual agonist,Phase 2)Infectious Disease/ImmunologySchizophreniaMK-8189(PDE10A,Phase 2)Treatment-Resistant DepressionM

39、K-1942(not yet disclosed,Phase 2)Alzheimers DiseaseMK-1942(not yet disclosed,Phase 2)MK-2214(Anti-Tau mAb,Phase 1)CardiometabolicNeuroscience1.Announced plans to initiate a new once daily oral Phase 3 clinical program in the treatment setting with a lower dose of islatravir in combination with dorav

40、irine.Pneumococcal Disease:AdultsV116(PCV,Phase 3)RSVClesrovimab(mAB,Phase 3)DengueV181(LATV,Phase 2)Pneumococcal Disease:PediatricsV117(PCV,Phase 1)HIV:TreatmentIslatravir1(NRTTI,Phase 3)RSVMolnupiravir(antiviral,Phase 2)HIV:PrEPMK-8527(NRTTI,Phase 1)ImmunologyMK-6194(IL-2 mutein,Phase 1b)Sotaterce

41、pt has the potential to transform the treatment of patients with PAH16PAH is a rare,rapidly progressive and fatal diseaseData presentation STELLAR data will be presented at ACC in March Merck to host investor meeting at ACC to discuss trial resultsPositive results for Phase 3 STELLAR trial Demonstra

42、ted a profound effect on improvement in six-minute walk distance from baseline at 24 weeks Met 8 of 9 secondary endpoints Targeting filing with regulatory authorities in 1Q 20231-yearmortality15.3%5-yearmortality43.0%Benza et al,Chest 2012;142(2):448-456Development strategy Phase 3 HYPERION,ZENITH a

43、nd SOTERIA trials in PAH are ongoingAdvancing population-specific approach to pneumococcal diseaseActive Bacterial Core Surveillance(ABCs)report emerging infections program network streptococcus pneumoniae,2019.Available:SPN Surveillance Report 2019.pdf(cdc.gov).Source:Epidemiology of pneumococcal d

44、isease and pneumococcal vaccine coverage in US children,Ryan Gierke,MPH.Advisory Committee on Immunization Practices,February 24th,2022.1.Centers for Disease Control and Prevention,IPD serotype data 2019,as compiled from data provided through Active Bacterial Core surveillance(ABCs).The serotypes th

45、at cause pediatric disease differ significantly from those that cause adult diseaseV117 Phase 1 investigational candidate specifically targeting serotypes associated with pediatric diseaseV116Phase 3 investigational candidate specifically targeting adult disease by covering serotypes that account fo

46、r 85%of all IPD in U.S.adults ages 651 as of 2019VAXNEUVANCEExpanding coverage while maintaining protection against historically invasive disease-causing serotypes in children,including during the first year of life,which represents nearly half of all IPD for children under 17 years old0510152025303

47、540100Enhance durable growth driversDeploy cash flow to value-enhancing BDLeverage leadership in oncologyAdvance pipeline across key therapeutic areasBuilding a sustainable engine to drive success into the next decade19Achieved meaningful progress across each lever in 2022Potential for$10B from new

48、mechanisms in oncologyapproaching the mid-2030sIncludes ADCs(e.g.TROP-2,ROR-1)and small molecules(e.g.inhibitors of CYP11A1,LSD-1,KRAS,BTK)Increased confidence in our sustainable engine to drive success into the next decadePotential for$10B from cardiovascular pipeline approaching the mid-2030sQ&ARo

49、b DavisChairman and Chief Executive OfficerDr.Dean LiPresident,Merck Research LaboratoriesAppendix21Full year continuing operationsGAAP to Non-GAAP financial results reconciliation22GAAPAcquisition and Divestiture-Related Costs(1)Restructuring Costs(2)(Income)Loss from Investments in Equity Securiti

50、esCertain Other Items(3)Non-GAAP2021Cost of sales$13,6261,607160221$11,638Selling,general and administrative9,634322199,293Research and development12,2454792811,738Restructuring costs661661-Earnings per Common Share Assuming Dilution from Continuing Operations$4.86(0.80)(0.30)0.580.01$5.37$in billio

51、ns,except EPS amounts2020Cost of sales$13,6183,355 175260$9,828 Selling,general and administrative8,955225478,683Research and development13,39712834513,257Restructuring costs575575-Earnings per Common Share Assuming Dilution from Continuing Operations$1.78(1.19)(0.31)0.40(0.09)$2.973Q YTD continuing

52、 operationsGAAP to Non-GAAP financial results reconciliation23GAAPAcquisition and Divestiture-Related Costs(1)Restructuring Costs(2)(Income)Loss from Investments in Equity SecuritiesCertain Other Items(3)Non-GAAPYTD2022Cost of sales$13,530 1,577167$11,786 Selling,general and administrative7,355 1377

53、47,144 Research and development9,773936308,807 Restructuring costs288288-Earnings per Common Share Assuming Dilution from Continuing Operations$4.53(0.76)(0.18)(0.39)$5.86$in billions,except EPS amountsYTD2021Cost of sales$9,752 1,188 113 225$8,226 Selling,general and administrative6,804 96 9 6,699

54、Research and development9,177 82 21 9,074 Restructuring costs487 487-Earnings per Common Share Assuming Dilution from Continuing Operations$3.36(0.46)(0.22)0.46 0.02$3.56 Full year and 3Q YTD Continuing operationsGAAP to Non-GAAP financial results reconciliation(contd)241.Amounts included in cost of

55、 sales primarily reflect expenses for the amortization of intangible assets.Amount in full year 2020 cost of sales also reflects a$1.6 billion intangible asset impairment charge related to ZERBAXA.Amounts included in selling,general and administrative expenses reflect integration,transaction and cer

56、tain other costs related to acquisitions and divestitures.Amounts included in research and development expenses primarily reflect the amortization of intangible assets,as well as$275 million and$887 million of intangible asset impairment charges related to the ArQule,Inc.acquisition in the full year

57、 2021 and the third quarter year-to-date 2022 period,respectively.2.Amounts primarily include employee separation costs and accelerated depreciation associated with facilities to be closed or divested related to activities under the Companys formal restructuring programs.3.Amounts in cost of sales and research and development expenses reflect charges for the discontinuation of COVID-19 development programs.EPS impacts in 2021 also reflect a net tax benefit of$207 million related to the settlement of certain federal income tax matters.