BMS-JPM-2025-presentation.pdf

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1、43rd Annual J.P.Morgan Healthcare ConferenceJanuary 13th,2025Christopher Boerner,Ph.D.,Board Chair and Chief Executive OfficerForward Looking Statements and Non-GAAP Financial Information2This presentation(as well as the oral statements made with respect to the information contained in this presenta

2、tion)contains statements about Bristol-Myers Squibb Companys(the“Company”)future financial results,plans,business development strategy,anticipated clinical trials,results and regulatory approvals that constitute forward-looking statements for purposes of the safe harbor provisions under the Private

3、Securities Litigation Reform Act of 1995.All statements that are not statements of historical facts are,or may be deemed to be,forward-looking statements.Actual results may differ materially from those expressed in,or implied by,these statements as a result of various factors,including,but not limit

4、ed to:(i)New laws and regulations,(ii)Our ability to obtain,protect and maintain market exclusivity rights and enforce patents and other intellectual property rights,(iii)Our ability to achieve expected clinical,regulatory and contractual milestones on expected timelines or at all,(iv)Difficulties o

5、r delays in the development and commercialization of new products,(v)Difficulties or delays in our clinical trials and the manufacturing,distribution and sale of our products,(vi)Adverse outcomes in legal or regulatory proceedings,(vii)Risks relating to acquisitions,divestitures,alliances,joint vent

6、ures and other portfolio actions and(viii)Political and financial instability,including changes in general economic conditions.These and other important factors are discussed in the Companys most recent annual report on Form 10-K and reports on Forms 10-Q and 8-K.These documents are available on the

7、 U.S.Securities and Exchange Commissions website,on the Companys website or from Bristol-Myers Squibb Investor Relations.No forward-looking statements can be guaranteed.In addition,any forward-looking statements and clinical data included herein are presented only as of the date hereof.Except as oth

8、erwise required by applicable law,the Company undertakes no obligation to publicly update any of the provided information,whether as a result of new information,future events,changed circumstances or otherwise.This presentation includes certain non-Generally Accepted Accounting Principles(“GAAP”)fin

9、ancial measures that we use to describe the Companys performance.The non-GAAP financial measures are provided as supplemental information and are presented because management has evaluated the Companys financial results both including and excluding the adjusted items or the effects of foreign curren

10、cy translation,as applicable,and believes that the non-GAAP financial measures presented portray the results of the Companys baseline performance,supplement or enhance managements,analysts and investors overall understanding of the Companys underlying financial performance and trends and facilitate

11、comparisons among current,past and future periods.This presentation also provides certain revenues and expenses or other financial measures excluding the impact of foreign exchange(“Ex-FX”).We calculate foreign exchange impacts by converting our current-period local currency financial results using

12、the prior period average currency rates and comparing these adjusted amounts to our current-period results.Ex-FX financial measures are not accounted for according to GAAP because they remove the effects of currency movements from GAAP results.The non-GAAP information presented herein provides inves

13、tors with additional useful information but should not be considered in isolation or as a substitute for the related GAAP measures.Moreover,other companies may define non-GAAP measures differently,which limits the usefulness of these measures for comparisons with such other companies.We encourage in

14、vestors to review our financial statements and publicly filed reports in their entirety and not to rely on any single financial measure.An explanation of these non-GAAP financial measures and a reconciliation to the most directly comparable financial measure are available on our website at note that

15、 a reconciliation of forward-looking non-GAAP measures,including non-GAAP Earnings per share(EPS),to the most directly comparable GAAP measures is not provided because comparable GAAP measures for such measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting a

16、nd quantifying measures that would be necessary for such reconciliation.Namely,we are not,without unreasonable effort,able to reliably predict the impact of accelerated depreciation and impairment charges,legal and other settlements,gains and losses from equity investments and other adjustments.In a

17、ddition,the Company believes such a reconciliation would imply a degree of precision and certainty that could be confusing to investors.These items are uncertain,depend on various factors and may have a material impact on our future GAAP results.The next chapter for BMS comes into focus3January 2024

18、 Outlined journey to deliver sustained top-tier growth by end of the decade Highlighted enablers:Performance of key growth brands Delivery of mid-late-stage pipeline assets Focused on importance of executionToday Key first and/or best in class medicines driving Growth Portfolio*Entering data-rich pe

19、riod,with multiple registrational readouts to define pipeline potential Focusing on disciplined execution*See Appendix Slide for composition of Growth Portfolio Advanced growth portfolio with double-digit sales growthExpanded presence in key TAs Re-established presence in neuroscience with Cobenfy E

20、xtended immuno-oncology portfolio durability with Opdivo Qvantig Advanced late-stage assets with significant potentialBolstered financial position Successful integration of strategic acquisitions Achieved majority of$1.5 billion productivity program and reinvested savings into high-ROI opportunities

21、 Progress towards$10 billion debt pay down commitment12024 execution has strengthened our foundation4Stronger portfolio,pipeline&financial flexibility entering 20251.Relative to the total debt level as of March 31,2024Delivering breakthrough medicines to even more patients even faster and compelling

22、 returns to our shareholdersOverarching strategic focus:Achieve sustained top-tier growth by end of the decade5Focusing on transformational medicines in areas where we have a competitive advantageDriving operational excellence throughout the organizationStrategically allocating capital for long-term

23、 growth and returnsFocusing on transformational medicines where we have competitive advantages6Key marketed productsKey Ph 2/3 programsInvestment prioritiesOncology/HematologyProtein degradationCell therapyComplex biologicsRadiopharmaceuticalsCardiovascularThrombosisCardiomyopathiesHeart failureNeur

24、oscience NeuropsychiatryNeurodegeneration ImmunologyControlling inflammationResetting immune memoryPromoting homeostasis 2156840 TotalFive products key to Growth Portfolio performance7Growth Portfolio expected to exceed 50%of revenues in 2025*See“Forward-Looking Statements and Non-GAAP Financial Inf

25、ormation.”;MDS:myelodysplastic syndrome;MF:myelofibrosis;oHCM:obstructive hypertrophic cardiomyopathy;nHCM:non-obstructive hypertrophic cardiomyopathy;SoC:standard of care;NSCLC:non-small cell lung cancerFirstin-class treatment in 1L MDS anemia with broad labelPotential MF anemia expansion with Phas

26、e 3 data expected in 2025*First-in-class treatment in oHCMnHCM expansion opportunity with Phase 3 data expected in 2025*Best-in-class CD19 CAR-T across the broadest array of B-cell malignancies Expanded manufacturing capabilities to unlock full potential Novel first-in-class schizophrenia treatment

27、with multiple high potential expansion opportunitiesLaunched late October 2024Firstin-class treatment,now a SoC in 1L melanomaExploring indication expansions(e.g.,1L NSCLC)Cobenfy launch off to a strong start with the first indication for schizophrenia8IQVIA Weekly NPA(Rapid)&APLD;Cobenfys TRx is ov

28、erall indications without normalization;TRx are projected at national level Cobenfy TRx“I had lots of hope for this medication,but no expectations.But now,I cant wait to try it on more patients.These results are phenomenal.This medicine makes you a hero and doctors want to be heroes”Dr.Parks in Cary

29、,IL0100200300400500600700800TRxThanksgivingChristmas&New Years01Consistent customer feedback highlights benefits of unique MoA across the three domains of schizophrenia02Cobenfy TRx performance is aligned to our expectations and ahead of branded schizophrenia launch benchmarks03Medicare&Medicaid cov

30、erage currently tracking ahead of expectations04Broader Commercial coverage expected in 2H25with several potential indications with multi-billion-dollar peak sales over the decade9Expected clinical data readout every year through the end of the decadeOngoing registrational study readoutPlanned regis

31、trational study readoutAlzheimers Disease Cognition6M1 people living with AD in U.S.202520262027202820292030+Alzheimers Disease Agitation 6M1 people living with AD in U.S.Bipolar I Disorder Impacts 1.4M3 patients in U.S.Alzheimers Disease Psychosis(ADEPT-1&4)6M1,2 people living with AD in U.S.Adjunc

32、tive Schizophrenia(ARISE)Expansion within schizophreniaAlzheimers Disease Psychosis(ADEPT-2)6M1,2 people living with AD in U.S.Autism Spectrum Disorder(Irritability)1.6M3 patients in U.S.Long-Acting Injectable*See“Forward-Looking Statements and Non-GAAP Financial Information.”1.“Alzheimers Disease A

33、ssociation Facts and Figures,”2023.2.Represents 40%of Alzheimers disease 3.DRG Clarivate,as of July 202320252025Entering data rich period with multiple catalysts1020252027 key milestones*Reblozyl TD MF Associated Anemia(INDEPENDENCE)Opdualag Adjuvant Melanoma(RELATIVITY-098)CAMZYOS nHCM(ODYSSEY)Cobe

34、nfy Adjunctive Schizophrenia(ARISE)Cobenfy Alzheimers Disease Psychosis(ADEPT-2)CD19 NEX-T Autoimmune Diseases(Breakfree-1&2)Krazati 1L NSCLC(TPS 30K transplant eligible NDMM patients in U.S./EU1Phase 3 data expected:202970K RRMM patients in U.S./EU1Phase 3 data expected:2026*LymphomaGolcadomide Eva

35、luating novel golcadomide combination regimens across aggressive&indolent lymphomas Ongoing pivotal trial evaluating golcadomide+R-CHOP in 1L high-risk LBCL60K 1L LBCL patients in U.S./EU1Phase 3 data expected:2028*See“Forward-Looking Statements and Non-GAAP Financial Information”1.Decision Resource

36、 Group,BMS Internal Analysis Treated Population;2.Please refer to ct.gov details:NCT04975997;NCT05827016;NCT05519085;NCT05552976;NCT06356129 Milvexian:Potential to redefine anticoagulant therapy for thrombotic diseases12*See“Forward-Looking Statements and Non-GAAP Financial Information”1.Developed i

37、n partnership with Johnson&Johnson 2.Please refer to ct.gov details:NCT05702034;NCT05754957;NCT05757869 3.Decision Resource Group,BMS Internal Analysis;EU represents EU5 Incidence 4.Decision Resource Group,BMS Internal Analysis Diagnosed PrevalenceFocused on addressing unmet medical need across thre

38、e large indications1,2LIBREXIA-STROKESecondary Stroke Prevention(25mg BID)Combining with dual antiplatelet therapy FXas not used due to excess bleeding risk Potential for improved efficacy(e.g.,stroke)without increasing bleeding risk1.3 million patients in U.S./EU3Phase 3 data expected:2026*LIBREXIA

39、-ACSAcute Coronary Syndrome(25mg BID)Similar underlying pathophysiology and treatment as stroke FXas not used due to excess bleeding risk Potential for improved efficacy(e.g.,CV death,MI)without increasing bleeding risk2 million patients in U.S./EU3Phase 3 data expected:2026*LIBREXIA-AFAtrial Fibril

40、lation(100mg BID)Monotherapy agent vs.apixaban;only oral FXIa potential in AF Potential for comparable efficacy with lower bleeding risk 40%of patients untreated or undertreated due to bleeding risk14 million patients in U.S./EU4Phase 3 data expected:2027*FXla inhibition offers promising next-genera

41、tion anticoagulant paradigm to improve patient careAdmilparant(LPA1 antagonist):Potential to transform the treatment of pulmonary fibrosis13ALOFT-IPF&ALOFTPPF2:Phase 3 registrational studies following a robust Phase 2 programSignificant unmet need IPF&PPF are fatal lung diseases with 35 years median

42、 survival1 Patients continue to experience progressive decline in lung function on approved therapies with limited treatment adherence due to tolerabilityU.S./EU prevalence3:IPF:233K,PPF:485KPulmonary Fibrosis market:$4 billion in sales in 20234Clinical rationale Deliver a new product with potential

43、ly improved efficacy and tolerability profile over current treatment options 60%improvement in lung-function decline vs.placebo with 60 mg dose in phase 2 in IPF;70%improvement in PPF5,6Phase 3 ALOFT-IPF&ALOFT-PPF ongoingPhase 3 data expected:2026*/2028*See“Forward-Looking Statements and Non-GAAP Fi

44、nancial Information”1.Raghu.Am J Respir Crit Care Med.2011 Mar 15;183(6):788-824;2.Please refer to ct.gov details:NCT06003426;NCT06025578;3.Decision Resource Group;4.Evaluate Pharma(Respiratory Disorders,Pulmonary Fibrosis);5.Corte TJ,et al.Am J Respir Crit Care Med.2023;207:A2785;6.Corte TJ,et al.E

45、RS 2023 Presentation#RCT800;IPF=Idiopathic pulmonary fibrosis;PPF=Progressive Pulmonary FibrosisPotential to be first and best-in-class,redefining the standard of care in pulmonary fibrosisUpcoming launch catalysts build upon existing portfolio andwill further strengthen our growth profile1420282030

46、2026Breyanzi MZL 3L+CamzyosnHCMCobenfy Adjunctive Schizophrenia OpdivoHCC AdjuvantOpdivo+chemo Peri-adjuvant MIUCReblozylMF anemia 1L+SotyktuPsA2027Cobenfy Alzheimers Disease PsychosisKrazati CRC 2LOpdualag Adjuvant Stage 34 MelanomaReblozyl Alpha Thalassemia2iberdomide RRMMmezigdomide RRMMobexelima

47、b IgG4-Related Diseases2RYZ101 GEP-NETs(SSTR+)Cobenfy Alzheimers Disease AgitationCobenfy Alzheimers Disease CognitionCobenfy Autism IrritabilityCobenfyBipolar I Disorderadmilparant PPFarlo-celMM 2L+CD19 NEX-T Auto-Immune Indicationsadmilparant IPFanti-CCR8Solid TumorsAR LDDProstate Cancerarlo-cel M

48、M 4L+Sotyktu SLEReblozyl MDS 1L NTD anemiaSotyktu Sjogrens Syndromemilvexian Atrial Fibrillationmilvexian SSPRYZ101 Breast Cancer 3L+E+H2-SSTR+RYZ101 SCLC 1L ES(SSTR+)golcadomide LBCL(high-risk)1LHELIOS CELMoDSolid Tumorsmilvexian ACSMYK-224 HFpEFKrazati NSCLC 1L KRAS(TPS 50%)Nivo+Rela HD+Chemo NSCL

49、C 1LKrazatiNSCLC 1L KRAS(TPS 50%)EGFR x HER3 ADC Additional Solid Tumorsgolcadomide FL 3L+iberdomide NDMM post-HSCT maintenanceatigotatug SCLC 1L ESBCMA x GPRC5D dual CAR-T RRMMCD19 NEX-T SLE Severe RefractoryEGFR x HER3 ADC Solid TumorsPRMT5iSolid Tumors2025Opdivo+YervoyCRC 1L+MSI HighOpdivo+Yervoy

50、HCC 1L*See“Forward-Looking Statements and Non-GAAP Financial Information”;Not an exhaustive list of assets,programs,or indications;subject to positive registrational trials and regulatory approval;planned launches as of December 31st,2024;1.Opdivo Qvantig January 2025 SC formulation launch,extending

51、 immuno-oncology franchise into early 2030s;2.Ex-US studyCurrently marketed Growth PortfolioGrowth Portfolio LCMNMENME LCM1Continuing to drive operational excellence15Note:See“Forward-Looking Statements and Non-GAAP Financial Information”Leveraging technology and AI across the organization to accele

52、rate pace of innovation,drive operational excellence and reduce cost baseAnnualized$1.5B in cost savings to be realized by the end of 2025Reinvesting savings in high return growth initiativesContinuing to review cost structure Evolving our organizationPrioritizing the highest value programsRaising t

53、he probability of success from first-in-human to approvalReducing cycle times to bring medicines to patients fasterImproving R&D productivityIncreasing efficiencyMaintaining a highly patient-centric approachGreater focus on accountability and acting with sense of urgencyStreamlining the organization

54、 and simplifying ways of workingInvestments in innovation Investing in our Growth Portfolio and R&D Pursuing business development and partnerships R&D investment of$28B over the past 3 years1,2,3 Business development investment of$27B over the past 3 years1,4Balance sheet strength Maintaining a stro

55、ng balance sheet that provides strategic flexibility Planned debt repayment of$10B by 1H265 Strong long-term investment grade credit ratingsReturning capital to shareholders Solid track record of returning capital to shareholders through$14B in dividends and$16B in share repurchases over the past 3

56、years1 93 consecutive years of dividend payments6Strategically allocating capital for long-term growth161.For the three years ended 9/30/2024 2.See“Forward-Looking Statements and Non-GAAP Financial Information”3.Refer to GAAP to Non-GAAP Reconciliation in Appendix 4.Represents Acquisition and other

57、payments,net of cash acquired 5.Relative to the total debt level as of March 31,2024 6.Latest dividend increase declared 12/11/2024 and payable 2/3/2025 on common stock of the companyReshaping BMS to deliver sustained top-tier growth&long term shareholder returns 17 Focusing on transformational medi

58、cines where we have an advantage Driving operational effectiveness throughout the organization Strategically allocating capital Significantly younger,more diversified and de-risked portfolio which is more balanced across leading TAsPotential 10+NMEs&30+major LCM indications in 20252030*Increased str

59、ategic flexibility resulting from financial disciplineIncreasing conviction in ability to deliver top-tier growth*See“Forward-Looking Statements and Non-GAAP Financial Information”(Unaudited,dollars in millions)Three Months EndedDecember 31,2021Year Ended December 31,2022Year EndedDecember 31,2023Ni

60、ne Months EndedSeptember 30,2024Three Years EndedSeptember 30,2024Research and development$2,518$9,509$9,299$7,968$29,294Specified items(a)-3081879741,469Research and Development excluding specified items$2,518$9,201$9,112$6,994$27,825Bristol Myers Squibb Company Reconciliation of Certain GAAP Line

61、Items to Certain Non-GAAP Line Items For the Three Year Period Ended September 30,2024(a)An explanation of these non-GAAP financial measures are available on our website at PortfolioLegacy Portfolio1.Other Growth Brands:Onureg,Inrebic,Nulojix,Empliciti,&Royalty revenuesOther Growth Brands1Other Matu

62、re Brands2024 environmental,social,and governance progress 21Named to the 2023 Dow Jones Sustainability World Indices1ASPIRE 10-year strategy announced,expanding access to patients in LMICs 6 consecutive years of beingawarded a top score on Disability Equality IndexSBTi validation of our near-term a

63、nd long-term net-zero targetsATOM coalition collaboration announced to provide access to our immuno-oncology therapies like OPDIVO in select LMICsESG strategyAdvancing patienthealth around the worldFostering a high-performing&inclusive global workforceReducing our environment impact One of Americas

64、100 Most JUST Companies,jumping from 349th position to 100th2024 Climate Change Report PublishedAccess to Medicine Index(ATMI)BMS climbed two spots to 13th out of 20 since 202210 consecutive years of being included in the FTSE4Good Index Series1.Index recognizes progress increasing workforce represe

65、ntation,reducing environmental impact,enhancing data privacy and cyber security programs,establishing principles for responsible artificial intelligenceClinical Development Portfolio Phase I and II 22Krazati1L Non-Small Cell Lung Cancer PD-L150%BreyanziRR Marginal Zone LymphomaGolcadomideRR Follicul

66、ar LymphomaArlocabtagene autoleucel(GPRC5D CAR T)RR Multiple MyelomaReblozylA-ThalassemiaMYK-224 Heart Failure with preserved Ejection FractionObstructive Hypertrophic Cardiomyopathyafimetoran Systemic Lupus ErythematosusBMS-986322(TYK2 Inhibitor)Moderate-to-Severe PsoriasisSotyktuDiscoid Lupus Eryt

67、hematosusAnti-MTBR Tau Alzheimers DiseaseAnti-CCR8 Solid TumorsBMS-986460 Prostate CancerBMS-986463 Solid TumorsBMS-986484 Solid TumorsBMS-986490 Solid TumorsFAK CELMoD Solid TumorsIKZF-PD CELMoD Solid Tumorsizalontamab brengitecan(EGFRxHER3 ADC)1L Non-Small Cell Lung Cancer*Solid Tumors*Metastatic

68、Non-Small Cell Lung CancerHelios CELMoD Solid TumorsJNK Inhibitor Solid TumorsKRASG12D Inhibitor Solid TumorsPRMT5 Inhibitor Solid TumorsRYZ101Extensive Stage Small Cell Lung CancerHR+/HER2-Unresectable Metastatic Breast CancerRYZ801 Hepatocellular CarcinomaSOS1 Inhibitor Solid TumorsBCL6 LDD Lympho

69、maCD33-GSPT1 ADC Acute Myeloid LeukemiaCD33 NKE Acute Myeloid LeukemiaCK1 Degrader Hematologic MalignanciesDual Targeting BCMAxGPRC5D CAR T RR Multiple MyelomaHbF Activating CELMoD Sickle Cell DiseaseBMS-986454 Autoimmune DiseaseCD19 NEX-TAutoimmune Diseases Severe Refractory Systemic Lupus Erythema

70、tosusIL2-CD25 Autoimmune DiseasePKC Inhibitor Autoimmune DiseaseBMS-986495 Neurodegenerative DiseasesCD19 NEX-TMultiple SclerosiseIF2B Activator Alzheimers DiseaseFAAH/MGLL Dual Inhibitor Neurodegenerative DiseasesTRPC4/5 Inhibitor Mood and Anxiety DisordersBMS-986465(TYK2 Inhibitor)Neuroinflammatio

71、n DisordersData as of Jan 13th,2025Phase IPhase IIHematologyNeuroscienceOncologyImmunologyCV*Partner-run study NME leading indicationClinical Development Portfolio Phase III 23AR LDD Metastatic Castration-Resistant Prostate Cancer Atigotatug(Anti-Fucosyl GM1)+nivolumab 1L Extensive Stage Small Cell

72、Lung CancerKrazati1L Non-Small Cell Lung Cancer PD-L150%2L Colorectal CancerNivolumab+Relatlimab HD 1L Non-Small Cell Lung CancerOPDIVOAdjuvant Hepatocellular CarcinomaPeri-adjuvant Muscle-Invasive Urothelial CarcinomaStage IB-IIIA Adjuvant Non-Small Cell Lung Cancer*OPDUALAGAdjuvant MelanomaRYZ101

73、2L+SSTR2+Gastroenteropancreatic Neuroendocrine TumorsSC nivolumab+relatlimab+rHuPH20 1L MelanomaGolcadomide High Risk 1L Large B-cell Lymphoma(Arlocabtagene autoleucel)(GPRC5D CAR T)24L Multiple MyelomaIberdomide 2L+Multiple MyelomaPost-ASCT Maintenance Newly Diagnosed Multiple MyelomaMezigdomide2L+

74、Multiple Myeloma Kd 2L+Multiple Myeloma VdReblozyl1L TD Myelofibrosis Associated Anemia1L NTD Myelodysplastic Syndrome Associated AnemiaCAMZYOSNon-Obstructive Hypertrophic CardiomyopathyMilvexianAcute Coronary Syndrome*Atrial Fibrillation*Secondary Stroke Prevention*Cendakimab Eosinophilic Esophagit

75、isEosinophilic Gastroenteritis#Admilparant Idiopathic Pulmonary FibrosisProgressive Pulmonary FibrosisObexelimab IgG4-Related DiseaseSotyktuPsoriatic ArthritisSjgrens SyndromeSystemic Lupus ErythematosusCobenfyAdjunctive SchizophreniaPsychosis in Alzheimers DiseaseAUGTYROROS1 NSCLC(EU)NTRK Pan-Tumor

76、(EU,JP)OPDIVOPeri-adjuvant Non-Small Cell Lung Cancer(EU)OPDIVO+YERVOY1L Hepatocellular Carcinoma(US,EU,JP)1L+Microsatellite Instability High Colorectal Cancer(JP)OPDIVO QVANTIG 2L Renal Cell Carcinoma(EU)BreyanziRR Follicular Lymphoma(EU)Development Partnerships:AUGTYRO:Zai Lab;izalontamab brengite

77、can(EGFRxHER3 ADC):SystImmune;Cobenfy:Zai Lab;Krazati:Zai Lab;milvexian:Johnson&Johnson;obexelimab:Zenas BioPharma;OPDIVO,YERVOY,OPDUALAG:Ono;PKC Inhibitor:Exscientia;Reblozyl:Merck;rHuPH20:HalozymeData as of Jan 13th,2025Phase IIIRegistration US,EU,JPHematologyNeuroscienceOncologyImmunologyCV*Partner-run study NME leading indication#Japan only