Bristol-myers Squibb Company · NYSE:BMY
Bristol-myers Squibb — Q3 2024 Earnings Presentation
56 slides from Bristol-myers Squibb's earnings presentation, Oct 31, 2024
Slide 1: Q3 2024 Results
Q3 2024 Results October 31, 2024 Not for Product Promotional Use
Slide 2: Forward Looking Statements and Non-GAAP Financial Information
Forward Looking Statements and Non-GAAP Financial Information This presentation contains statements about Bristol-Myers Squibb Company’s (the believes that the non-GAAP financial measures presented portray the results of the “Company”) future financial results, plans, business development strategy,
Slide 3: Chris Boerner, PhD
Q3 2024 Results Chris Boerner, PhD Board Chair and Chief Executive Officer 3
Slide 4: Q3 2024 performance
Q3 2024 performance Commercial Research & Development Growth portfolio revenues: +18% or +20% Ex-FX* YoY Achieved multiple clinical & regulatory milestones1 $ in billions Re-established presence in Neuroscience $11.9 $11.0 $6.1 $6.0 Legacy Growth $4.9 $5.8 Q3 2023 Q3 2024 +40% +80% nivolumab + relat
Slide 5: Launch now underway
Launch now underway Anticipate majority of access by 2H 2025* First new mechanism in decades • ~1.6M patients treated in the U.S.1 • ~70% of patients not well managed with current treatments Novel first-in-class Compelling efficacy with proven safety & tolerability profile schizophrenia • Depth & br
Slide 6: Reshaping the company for long-term sustainable growth
Reshaping the company for long-term sustainable growth Focusing on transformational medicines Driving operational excellence Strategically allocating capital where we have a competitive advantage throughout the organization for long-term growth & returns • Growth portfolio led by Reblozyl, • Focusin
Slide 7: Near-term milestones build pipeline
CAR T in CD19 NEX-T Immunology Phase 1 data at ACR: November 2024 Near-term milestones Extending in build pipeline Subcutaneous nivolumab Immuno- momentum *1 Oncology U.S. FDA PDUFA date: December 29th Expanding in Immunology Phase 3 PsA POETYK-PsA-I & II: data by YE Pipeline enters catalyst-rich pe
Slide 8: Raising our 2024 revenue and EPS outlook
Raising our 2024 revenue and EPS outlook 2024 Guidance Highlights* Total Revenues Expected to increase ~5% Reported Rates Total Revenues Expected to increase ~6% Ex-FX Increasing range to Non-GAAP EPS1 $0.75 - $0.95 *The Company does not reconcile forward-looking non-GAAP measures. See “Forward-Look
Slide 9: Executing on critical business priorities to build a solid foundation
Focusing on commercial execution • Growth Portfolio continues to expand Executing on Re-established presence in Neuroscience critical business • Cobenfy U.S. approval: Multi-billion-dollar potential including LCM priorities to build opportunities a solid foundation Advancing our pipeline for sustain
Slide 10: David Elkins
Q3 2024 Results David Elkins Executive Vice President and Chief Financial Officer 10
Slide 11: Composition of revenue continues to transition to the Growth Portfolio
Composition of revenue continues to transition to the Growth Portfolio Growth Portfolio Legacy Portfolio $ in billions +8% YoY, +10% Ex-FX* $6.1 $6.0 $5.8 $4.9 Other Growth Brands1 Other Mature Brands Q3 2023 Q3 2024 +18% +20% +1% +1% Legacy Growth YoY Ex-FX* YoY Ex-FX* *See “Forward-Looking Stateme
Slide 12: Q3 2024 Oncology product summary
Q3 2024 Oncology product summary Global Net Sales $M YoY % Ex-FX* % Opdivo2: $2,360 +4% +7% • Global sales growth reflects increased volume • Subcutaneous nivolumab: U.S. FDA PDUFA date $642 +11% +13% December 29, 2024 1 $253 (3%) +1% Opdualag3: • U.S. growth driven by strong demand; achieved $233 +
Slide 13: Q3 2024 Cardiovascular product summary
Q3 2024 Cardiovascular product summary Eliquis: Best-in-class & leading OAC within category Global Net Sales • U.S. growth driven by strong underlying demand & increasing market share % $M YoY % Ex-FX* % • #1 OAC in key Ex-U.S. markets1 Camzyos: First-in-class myosin inhibitor $3,002 +11% +11% • Str
Slide 14: Q3 2024 Hematology product summary
Q3 2024 Hematology product summary Global Net Sales 1 $M YoY % Ex-FX* % Reblozyl: $1,412 (1%) (1%) • Strong demand in 1L MDS-associated anemia • Focus on increasing market share in 1L RS negative 1 $898 +3% +3% population • Ex-U.S. growth driven by both European markets3 & $447 +80% +81% recent Japa
Slide 15: Q3 2024 Immunology product summary
Q3 2024 Immunology product summary Global Net Sales Sotyktu: First-in-class TYK2 inhibitor • ~15% sequential growth in commercially paid scripts % $M YoY % Ex-FX % * in the U.S. $936 +1% +3% • Launched in major ex-U.S. markets • Continued focus on demand growth & access $147 +20% +19% improvements S
Slide 16: Q3 2024 Financial Performance
Q3 2024 Financial Performance US US GAAP GAAP Non-GAAP Non-GAAP * $ in billions, except EPS Q3 2024 Q3 2023 Q3 2024 Q3 2023 Total Revenues, net 11.9 11.0 11.9 11.0 Gross Margin % 75.1% 77.1% 76.0% 77.3% Operating Expenses1 4.4 4.2 4.3 4.1 Acquired IPR&D 0.3 0.1 0.3 0.1 Amortization of Acquired Intan
Slide 17: Strategic approach to Capital Allocation
Strategic approach to Capital Allocation Cash flow from Operations $B Business • Pursue opportunities and partnerships to diversify Development portfolio & strengthen long-term outlook $5.6 $4.8 $4.3 • Maintain strong investment-grade credit rating $2.8 $2.3 Balance Sheet • Planned debt pay down of
Slide 18: Revised 2024 Guidance
Revised 2024 Guidance Non-GAAP* Key Highlights July (Prior) October (Updated) Total Revenues Upper end of • Raising FY Revenue & EPS guidance due ~5% increase to strength of results YTD Reported Rates low single-digit range Total Revenues Upper end of • Gross Margin range narrowed due to ~6% increas
Slide 19: Delivered Solid Performance in Q3
Delivered Solid Performance in Q3 • Topline growth: +8% or +10% Ex-FX* Q3 Performance • Growth portfolio: +18% or +20% Ex-FX* • Cobenfy: First-in-class medicine with multi-billion-dollar Re-established Presence in potential including LCM opportunities Neuroscience • Launch in schizophrenia now under
Slide 20: Q3 2024 Results Q&A
Q3 2024 Results Q&A Chris Boerner, PhD David Elkins Samit Hirawat, MD Adam Lenkowsky Board Chair, Executive VP, Executive VP, Executive VP, Chief Executive Officer Chief Financial Officer Chief Medical Officer, Chief Commercialization Officer Global Drug Development 20
Slide 21: Q3 2024 Opdivo Sales Mix
Q3 2024 Opdivo Sales Mix U.S. Sales Mix Ex-U.S. Sales Mix 27% 2% 26% 23% 22% 26% 8% 18% 23% 25% Note: percentages are approximate Q3 2024 Results Not for Product Promotional Use 21
Slide 22: Q3 2024 Eliquis NBRx/TRx Share
Q3 2024 Eliquis NBRx/TRx Share NBRx Share – US TRx Share – US 22% 20% 24% 22% 8% 7% 12% 11% 70% 73% 67% 64% Q3 2023 Q3 2024 Q3 2023 Q3 2024 Eliquis Warfarin Other NOACs Rx Source: IQVIA Q3 2024 Results Not for Product Promotional Use 22
Slide 23: Pipeline enters catalyst-rich period starting next year
Pipeline enters catalyst-rich period starting next year 2025–2026 key milestones* Growth Products indication expansion1 NME registrational data1 Key early-stage data • Reblozyl 1L TD MF associated anemia • Milvexian LIBREXIA program • EGFR x HER3 ADC (INDEPENDENCE) Advanced solid tumors • LPA1 IPF (
Slide 24: 8 new registrational trials added in oncology since last year
8 new registrational trials added in oncology since last year Registrational programs Studies underway Newly planned Anti-Fucosyl EGFR x HER3 RYZ101 Nivo + Rela HD Nivo + Rela HD AR LDD GM11 ADC 2L CRC 2L+ GEP-NETs 1L NSCLC 1L NSCLC 1L NSCLC Solid Tumors 1L ES-SCLC mCRPC PD-L1≥50% PD-L1 1–49% & NSQ
Slide 25: Composition of Other Growth & Other Legacy Products
Composition of Other Growth & Other Legacy Products Other Growth Products1 Other Legacy Products • Onureg • Idhifa • Inrebic • Istodax • Empliciti • Thalomid • Nulojix • Glucophage • 3rd Party Royalty Revenue • Kenalog • Vidaza • Baraclude • Reyataz • Other Mature Brands 1. Any brands not listed in
Slide 26: Clinical Development Portfolio — Phase I and II
Clinical Development Portfolio — Phase I and II Data as of Oct 31st, 2024 Phase I Phase II Anti-CCR8 Solid Tumors KRAZATI 1L Non-Small Cell Lung Cancer PD-L1<50% AR LDD Metastatic Castration-Resistant Prostate Cancer BREYANZI RR Marginal Zone Lymphoma BMS-986460 Prostate Cancer golcadomide RR
Slide 27: Clinical Development Portfolio — Phase III
Clinical Development Portfolio — Phase III Data as of Oct 31st, 2024 Phase III Registration US, EU, JP Anti-Fucosyl GM1 + nivolumab 1L Extensive Stage Small Cell Lung Cancer ROS1 NSCLC (EU) 1L Non-Small Cell Lung Cancer PD-L1≥50% AUGTYRO KRAZATI NTRK Pan-Tumor (EU) 2L Colorectal Cancer OPDIVO Peri
Slide 28: Environmental, Social, & Governance
Environmental, Social, & Governance As a leading biopharma company, we understand our responsibility extends well beyond discovery, development and delivery of innovative medicines. Our evolving ESG strategy builds on a legacy of sustainability efforts. Importantly, we are aligning our commercial st
Slide 29: Q3 2024 key clinical trials update
Q3 2024 key clinical trials update Oncology Hematology Immunology Cardiovascular Neuroscience • Opdivo • Reblozyl • Sotyktu • Camzyos • Cobenfy • Opdualag • BMS-986393 • cendakimab • milvexian • Anti-MTBR-Tau • Nivo+Rela HD • iberdomide • admilparant • MYK-224 • Krazati • mezigdomide • obexelimab •
Slide 30: Opdivo (anti-PD1)
Oncology Hematology Immunology Cardiovascular Neuroscience Opdivo (anti-PD1) Indication Periadjuvant NSCLC Stage IB-IIIA Adjuvant NSCLC Adjuvant HCC Peri-Adjuvant MIUC Phase III – ANVIL Phase/Study Phase III – CheckMate -77T Phase III – CheckMate -9DX Phase III – CA017-078 Non-BMS Sponsored* # of Pa
Slide 31: Opdivo (anti-PD1)
Oncology Hematology Immunology Cardiovascular Neuroscience Opdivo (anti-PD1) Indication 1L HCC 1L+ MSI High CRC 2L RCC SC Phase/Study Phase III – CheckMate -9DW Phase III – CheckMate -8HW Phase III – CheckMate -67T # of Patients N = 732 N = 831 N = 454 • Opdivo 1 mg/kg + Yervoy 3 mg/kg Q3W • Opdivo
Slide 32: Opdualag (anti-PD1 + anti-LAG3 FDC)
Oncology Hematology Immunology Cardiovascular Neuroscience Opdualag (anti-PD1 + anti-LAG3 FDC) Indication Adjuvant Stage III/IV Melanoma 1L Melanoma SC Phase/Study Phase III – RELATIVITY-098 Phase III – RELATIVITY-127 # of Patients N = 1050 N = 814 • Relatlimab + nivolumab FDC IV 160 mg/480 mg Q4W •
Slide 33: Nivolumab + Relatlimab HD (anti-PD1 + anti-LAG3 FDC)
Oncology Hematology Immunology Cardiovascular Neuroscience Nivolumab + Relatlimab HD (anti-PD1 + anti-LAG3 FDC) Indication 1L NSCLC Phase/Study Phase III # of Patients N = 800 • Nivolumab + Relatlimab FDC IV 360 mg/360 mg + chemotherapy Q3W • Pembrolizumab 200 mg + chemotherapy IV Q3W Design • Prima
Slide 34: Krazati (KRAS G12C inhibitor)
Oncology Hematology Immunology Cardiovascular Neuroscience Krazati (KRASG12C inhibitor) Indication 1L NSCLC PD-L1≥50% 1L NSCLC PD-L1<50% Phase/Study Phase II/III – KRYSTAL-7 Phase II – KRYSTAL-17 # of Patients N = 806 N = 90 Phase II: • Cohort A: Adagrasib 400 mg BID for 2 cycles followed by adagras
Slide 35: Krazati (KRAS G12C inhibitor)
Oncology Hematology Immunology Cardiovascular Neuroscience Krazati (KRASG12C inhibitor) Indication 2L CRC 3L+ CRC, 2-3L Pancreatic, Advanced Solid Tumors Phase/Study Phase III – KRYSTAL-10 Phase I/II – KRYSTAL-1 # of Patients N = 461 N = 822 • Adagrasib + cetuximab Phase I: • Chemotherapy • Dose exp
Slide 36: BMS-986489 (anti-Fucosyl-GM1 + nivolumab)
Oncology Hematology Immunology Cardiovascular Neuroscience BMS-986489 (anti-Fucosyl-GM1 + nivolumab) Indication 1L ES-SCLC Phase/Study Phase III - TIGOS # of Patients N = 530 • BMS-986489 (anti-fucosyl-GM1 + nivolumab FDC) combined with carboplatin + etoposide IV Q3W followed by BMS-986489 maintenan
Slide 37: BMS-986507 (EGFR x HER3 ADC)
Oncology Hematology Immunology Cardiovascular Neuroscience BMS-986507 (EGFR x HER3 ADC) Indication 1L NSCLC & Advanced Solid Tumors Advanced Solid Tumors Phase I – LUNG-101 CA244-0001 Phase/Study Non-BMS Sponsored* Phase I/IIa # of Patients N = 260 N = 218 • Cohort A: BMS-986507 D1/D8 Q3W schedule •
Slide 38: RYZ101 225Ac-DOTATATE (SSTR2 binder)
Oncology Hematology Immunology Cardiovascular Neuroscience RYZ101 225Ac-DOTATATE (SSTR2 binder) Indication 2L+ SSTR2+ GEP-NETs* HR+/HER2- Unresectable Metastatic Breast Cancer Phase/Study Phase Ib/III – ACTION-1 Phase Ib/II – TRACY-1 # of Patients Phase Ib N = 17; Phase III N = 288 N = 172 Phase Ib:
Slide 39: Reblozyl (Erythroid Maturation Agent)
Oncology Hematology Immunology Cardiovascular Neuroscience Reblozyl (Erythroid Maturation Agent) 1L TD Myelofibrosis (MF) 1L NTD Low-or Intermediate Risk Indication Associated Anemia Myelodysplastic Syndrome (MDS) Associated Anemia Phase/Study Phase III – INDEPENDENCE Phase III – ELEMENT-MDS # of Pa
Slide 40: Reblozyl (Erythroid Maturation Agent)
Oncology Hematology Immunology Cardiovascular Neuroscience Reblozyl (Erythroid Maturation Agent) Indication TD & NTD Alpha-Thalassemia (Ex-US study) Phase/Study Phase II # of Patients N = 177 • Reblozyl 1.0 mg/kg SC Q3W • Placebo SC Q3W + Best Supportive Care Design Primary: • TD: ≥50% reduction in
Slide 41: BMS-986393 (GPRC5D CAR T)
Oncology Hematology Immunology Cardiovascular Neuroscience BMS-986393 (GPRC5D CAR T) Indication 4L+ MM1 2-4L MM2 Phase/Study Phase II – QUINTESSENTIAL Phase III – QUINTESSENTIAL-2 # of Patients N = 150 N = 440 • BMS-986393 • BMS-986393 • Standard regimens (DPd or Kd) as per Investigator’s Design dis
Slide 42: iberdomide (CELMoD)
Oncology Hematology Immunology Cardiovascular Neuroscience iberdomide (CELMoD) Indication 2L+ MM Post-Transplant Maintenance NDMM Phase/Study Phase III – EXCALIBER Phase III – EXCALIBER-Maintenance # of Patients N = 864 N = 1216 • Iberdomide 1.0, 1.3, 1.6 mg + daratumumab 1800 mg + dex • Iberdomide
Slide 43: mezigdomide (CELMoD)
Oncology Hematology Immunology Cardiovascular Neuroscience mezigdomide (CELMoD) Indication 2L+ MM 2L+ MM Phase/Study Phase III – SUCCESSOR-1 Phase III – SUCCESSOR-2 # of Patients N = 810 N = 575 • Mezigdomide 0.3, 0.6, 1.0 mg + bortezomib 1.3 mg/m2a + dex • Mezigdomide 0.3, 0.6, 1.0 mg + carfilzomib
Slide 44: golcadomide (CELMoD)
Oncology Hematology Immunology Cardiovascular Neuroscience golcadomide (CELMoD) Indication High-Risk 1L LBCL Newly Diagnosed Advanced Stage 1L FL Phase/Study Phase III – GOLSEEK-1 Phase II – GOLSEEK-2 # of Patients N = 850 N = 90 • Golcadomide 0.4 mg + R-CHOP • Golcadomide Dose 1 + Rituximab • Place
Slide 45: Sotyktu (TYK2 inhibitor)
Oncology Hematology Immunology Cardiovascular Neuroscience Sotyktu (TYK2 inhibitor) Indication Psoriatic Arthritis (PsA) Phase/Study Phase III – POETYK-PsA-1 Phase III – POETYK-PsA-2 # of Patients N = 670 N = 700 52-week study of patients with active PsA in TNF-naïve patients 52-week study of patien
Slide 46: Sotyktu (TYK2 inhibitor)
Oncology Hematology Immunology Cardiovascular Neuroscience Sotyktu (TYK2 inhibitor) Indication Discoid Lupus Erythematosus (DLE) Systemic Lupus Erythematosus (SLE) Sjogren’s (SjS) Phase/Study Phase II - IM011-132 Phase III – POETYK SLE-1 Phase III – POETYK SLE-2 Phase III – POETYK SjS-1 # of Patient
Slide 47: cendakimab (anti-IL-13)
Oncology Hematology Immunology Cardiovascular Neuroscience cendakimab (anti-IL-13) Eosinophilic Gastroenteritis (EGE) Indication Eosinophilic Esophagitis (EoE) (Japan study) Phase/Study Phase III – CC-93538-EE-001 Phase III – CC-93538-EG-001 # of Patients N = 430 N = 48 • Cendakimab 360 mg SC QW for
Slide 48: admilparant (LPA1 antagonist)
Oncology Hematology Immunology Cardiovascular Neuroscience admilparant (LPA1 antagonist) Indication Idiopathic Pulmonary Fibrosis Progressive Pulmonary Fibrosis Phase/Study Phase III – ALOFT-IPF Phase III – ALOFT-PPF # of Patients N = 1185 N = 1092 • LPA1 Dose 60 mg BID • LPA1 Dose 60 mg BID • LPA1
Slide 49: obexelimab (CD19 x FcγRIIB bifunctional mAb)
Oncology Hematology Immunology Cardiovascular Neuroscience obexelimab (CD19 x FcγRIIB bifunctional mAb) Indication IgG4-Related Disease Phase/Study Phase III – INDIGO # of Patients N = 200 • Obexelimab SC • Placebo SC Design • Primary: Time to first IgG4-RD flare that requires initiation of rescue t
Slide 50: Camzyos (myosin inhibitor)
Oncology Hematology Immunology Cardiovascular Neuroscience Camzyos (myosin inhibitor) Indication Non-Obstructive Hypertrophic Cardiomyopathy (nHCM) Phase/Study Phase III – ODYSSEY-HCM # of Patients N = 580 • Camzyos • Placebo Design Primary: • Change from baseline in Clinical Summary Score (KCCQ-23
Slide 51: milvexian (FXIa inhibitor)
Oncology Hematology Immunology Cardiovascular Neuroscience milvexian (FXIa inhibitor) Indication Secondary Stroke Prevention Acute Coronary Syndrome Non-Valvular Atrial Fibrillation Phase III – LIBREXIA-STROKE Phase III – LIBREXIA-ACS Phase III – LIBREXIA-AF Phase/Study Non-BMS Sponsored* Non-BMS Sp
Slide 52: MYK-224 (myosin inhibitor)
Oncology Hematology Immunology Cardiovascular Neuroscience MYK-224 (myosin inhibitor) Indication Heart Failure with Preserved Ejection Fraction (HFpEF) Phase/Study Phase IIa – AURORA-HFpEF # of Patients N = 48 • MYK-224 • Placebo Design Primary: • TEAEs and SAEs • AEs leading to treatment discontinu
Slide 53: Cobenfy (M1/M4 muscarinic agonist & M1 antagonist)
Oncology Hematology Immunology Cardiovascular Neuroscience Cobenfy M1/M4 muscarinic agonist & M1 antagonist) Indication Adjunctive Schizophrenia Phase/Study Phase III – ARISE # of Patients N = 360 • Cobenfy 50 mg/20 mg BID, 75mg/20 mg BID, 100mg/20 mg BID, 125mg/30 mg BID* • Placebo Design • Primary
Slide 54: Cobenfy (M1/M4 muscarinic agonist & M1 antagonist)
Oncology Hematology Immunology Cardiovascular Neuroscience Cobenfy (M1/M4 muscarinic agonist & M1 antagonist) Indication Psychosis in Alzheimer’s Disease Phase/Study Phase III – ADEPT-1 Phase III – ADEPT-2 Phase III – ADEPT-4 # of Patients N = 380 N = 400 N = 406 • Cobenfy 20 mg/2 mg TID, 30 mg/3 mg
Slide 55: BMS-986446 (anti-MTBR-tau)
Oncology Hematology Immunology Cardiovascular Neuroscience BMS-986446 (anti-MTBR-tau) Indication Alzheimer's Disease Phase/Study Phase II – TargetTau-1 # of Patients N = 475 • BMS-986446 Dose A • BMS-986446 Dose B • Placebo Design Primary: • Mean change from baseline in CDR-SB score Endpoints Second
Slide 56: Abbreviations
Oncology Hematology Immunology Cardiovascular Neuroscience Abbreviations Ac Actinium Dd Daratumumab–Durvalumab HR+ Hormone Receptor Positive ND Newly Diagnosed QW Once Weekly ACG American College of Gastroenterology DFS Disease-free survival IgG4-RD Immunoglobulin G4-Related Disease NEJM New England
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