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- 15 Feb 24 Departure of Directors or Certain Officers
- 14 Feb 24 Bristol Myers Squibb Recommends Stockholders Reject “Mini-Tender” Offer by Tutanota LLC
- 2 Feb 24 Bristol Myers Squibb Reports Fourth Quarter and Full-Year Financial Results for 2023
- 8 Jan 24 Regulation FD Disclosure
- 22 Dec 23 Bristol Myers Squibb Strengthens Neuroscience Portfolio with Acquisition of Karuna Therapeutics
- 13 Nov 23 Other Events
- 31 Oct 23 Departure of Directors or Certain Officers
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Exhibit 99.1
January 8, 2024 J.P. Morgan Presentation
Forward looking statements and non-GAAP financial information 2 This presentation (as well as the oral statements made with respect to information contained in this presentation) contains statements about Bristol-Myers Squibb Company’s (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 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 limited 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 or 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 ventures 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 Company’s most recent annual report on Form 10-K and quarterly reports on Form 10-Q and current reports on Form 8-K. These documents are available on the U.S. Securities and Exchange Commission’s website, on the Company’s 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 otherwise 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 does not constitute a solicitation of a proxy, an offer to purchase or a solicitation of an offer to sell any securities. This presentation includes certain non-Generally Accepted Accounting Principles (“GAAP”) financial measures that we use to describe the Company’s performance. The non-GAAP financial measures are provided as supplemental information and are presented because management has evaluated the Company’s financial results both including and excluding the adjusted items or the effects of foreign currency translation, as applicable, and believes that the non-GAAP financial measures presented portray the results of the Company’s baseline performance, supplement or enhance management’s, analysts’ and investors’ overall understanding of the Company’s underlying financial performance and trends and facilitate 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 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 investors with additional useful information but should not be considered in isolation or as substitutes 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 investors 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 provided with this presentation and available on our website at www.bms.com/investors. Also note that a reconciliation of forward-looking non-GAAP gross margin, non-GAAP operating margin, non-GAAP operating expenses and non-GAAP tax rate is not provided because a comparable GAAP measure for such measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and quantifying measures that would be necessary for such reconciliation. Namely, we are not, without unreasonable effort, able to reliably predict the impact of the unwind of inventory purchase price adjustments, accelerated depreciation and impairment of property, plant and equipment and intangible assets, and stock compensation resulting from acquisition-related equity awards, or currency exchange rates. In addition, 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.
We are writing the next chapter in our history 3 Our overarching goal is to achieve sustainable, top-tier growth by the end of the decade BMS has entered another period of renewal in its long history of scientific achievements and delivering innovative medicines to patients We have a Growth Portfolio positioned to generate a more diverse company over the decade, with strong cash flow from legacy brands to invest We are focused on maximizing performance through 2025 and navigating our transition period in the middle of the decade
We will navigate a dynamic environment 4 4 Evolution of the global regulatory and access environment (e.g., IRA) Loss of exclusivity for multiple major products Increasingly intense competitive environment Industry Headwinds
Our overarching goal is to achieve sustainable, top-tier growth Transition period Maximize performance through 2025 Sustainable, top-tier growth from late 2020s 5 Revenue, illustrative
BMS enters this period with a number of key strengths 6 Robust & innovative pipeline Differentiated platforms with significant potential Financial strength & flexibility Growing position in large, attractive TAs Profitable business with meaningful cash generation Strong balance sheet with flexibility to invest Continued commitment to return cash to shareholders Center of the innovative cell therapy ecosystem Industry-leading capabilities in targeted protein degradation Differentiated actinium-based radiopharmaceutical platform1 Expanding registrational pipeline, growing from 6 to 12 assets Robust early-stage pipeline with 30+ assets and opportunity to deliver ~10 INDs per year Leadership positions in Oncology, Hematology & Cardiovascular Growing presence in Immunology & Neuroscience Recently launched assets with significant growth potential 1. Subject to satisfaction of customary closing conditions; anticipated closing of RayzeBio in 1H 2024
11 major brands across 4 TAs + 12 assets in/entering registrational stage + 30+ assets in early-stage clinical development + Assets from ongoing BD Legacy Portfolio Growth Portfolio We have a valuable Growth Portfolio 7 Generating strong cash flow and flexibility to invest in growth Including a more diversified and robust range of products ~$25B sales (2023) Cardiovascular Oncology Hematology Immunology 1 Legacy: Small Molecule Post-LoE products or products with ≤3 years to potential impact from major LoE or IRA; Growth: >3 years until major LoE event or potential IRA impact. “Major” brands include those with $1Bn+ risk-adjusted consensus annual sales; Only logos for major brands are shown 1. Subject to satisfaction of customary closing conditions; anticipated closing of Mirati by 1H 2024; 2. Partnered with 2SeventyBio 2 NOT FOR PRODUCT PROMOTIONAL USE
Focus on disciplined execution How we will deliver 8 Build on our leadership in Oncology, Hematology & Cardiovascular Continue to grow our presence in Immunology & Neuroscience Strategic capital allocation Maximize valuefrom our differentiated pipeline & platforms
Focus on disciplined execution How we will deliver 9 Build on our leadership in Oncology, Hematology & Cardiovascular Continue to grow our presence in Immunology & Neuroscience Strategic capital allocation Maximize valuefrom our differentiated pipeline & platforms
Oncology: Our strategy to build on our leadership 10 Not exhaustive of assets, programs, or indications 1. U.S. Regulatory path opens up indications with Q2W and Q4W; 2. Subject to satisfaction of customary closing conditions; anticipated closing of Mirati, SystImmune, and RayzeBio in 1H 2024 Extend durability in IO Expand into targeted therapies Deepen platform capabilities Cell Therapy ADC 2 2 Radiopharmaceutical therapy Targeted protein degradation 15+ additional oncology assets in Ph 1/2 2 subcutaneous nivolumab1 AR LDD Exploring in solid tumors NOT FOR PRODUCT PROMOTIONAL USE
Subcutaneous nivolumab & Opdualag: Extending durability of our IO business 11 Melanoma Lung GI/Other Other 2022 Melanoma Lung Renal GI/Other 2028 $8B Revenue, not to scale Potential to address 65-75% of Opdivo U.S. indications2 Opportunity to further extend with IO pipeline Renal subcutaneous nivolumab1 1. U.S. Regulatory path opens indications with Q2W and Q4W; 2. Assume extrapolation to non-Yervoy combinations and converting at least half of addressable population NOT FOR PRODUCT PROMOTIONAL USE
Hematology: Strengthening our position across a broad array of conditions 12 5+ additional hematology assets in Ph 1/2 Extend leadership in multiple myeloma Transform outcomes in leukemia / lymphoma Expand impact in non-malignant heme Expansion opportunities across 1L TD MF, 1L NTD MDS, and alpha-thalassemia2 Best-in-class CAR T approved with the broadest label in LBCL Not exhaustive of assets, programs, or indications; 1. Developed in partnership with 2SeventyBio; 2. Ex-US study Complex biologics Targeted protein degradation iberdomide mezigdomide alnuctamab Cell Therapy GPRC5D GPRC5D x BCMA golcadomide Targeted protein degradation ADC GSPT1 degrader NOT FOR PRODUCT PROMOTIONAL USE 1
Significant increase in manufacturing capacity planned this year Breyanzi: Best-in-class CAR T across the broadest array of B-cell malignancies 13 LBCL CLL / SLL FL / MCL Potential Patient Base Patient population size, not to scale Broadest label in 2L+ LBCL ~4x+ increase in median EFS First & only registrational data for CLL / SLL FDA Priority Review PDUFA: March 2024 Potential best-in-disease (R/R FL) 96% complete response Approved Registrational Phase I or II LBCL: Large B-Cell Lymphoma; CLL: Chronic Lymphocytic Leukemia, SLL: Small Lymphocytic Lymphoma; FL: Follicular Lymphoma, MCL: Mantle Cell Lymphoma; 1. Assumes regulatory approval for CLL/SLL, FL, & MCL >2x expansion1 No other CD19 CAR T approved NOT FOR PRODUCT PROMOTIONAL USE
Reblozyl: Significant growth opportunities in MDS-associated anemia and beyond Ongoing registrational studies 1L TD myelofibrosis(INDEPENDENCE) – 2025 1L NTD MDS (ELEMENT) – 2027 Exploratory / PoC studies Alpha-thalassemia2 – 2025 New standard of care in 1L MDS-associated anemia 1L approval increases market opportunity by ~4x Opportunity to further expand1 2023 U.S. patient estimates 2L+ RS+ MDS 1L MDS ~2K ~8K First and only therapy to demonstrate head-to-head superiority over epoetin alpha Approved in the U.S. with a broad label in lower-risk MDS-associated anemia Global filings underway 14 1. Years indicate expected data readouts; 2. Ex-US study NOT FOR PRODUCT PROMOTIONAL USE
Cardiovascular: Opportunity for sustained leadership with impact for millions of patients 15 Not exhaustive of assets, programs, or indications 1. Developed in partnership with J&J Innovative Medicines Growing opportunity in cardiomyopathies and heart failure Extending successful history in thrombosis MYK-224 milvexian1 Expansion opportunities in CV diseases with Avidity Biosciences collaboration NOT FOR PRODUCT PROMOTIONAL USE
Potential expansion in symptomatic nHCM (ODYSSEY-HCM): Phase 3 trial underway to expand the market; data expected in 2025 Camzyos: First and only myosin inhibitor approved in oHCM 16 Q1 Q2 Q3 Q4 Q5 Q6 Camzyos Entresto Strong launch momentum Significant untapped potential within oHCM Levers to deliver Time post-launch, quarters 1. Mizuho Research (Dec 2023) 2. Entresto & Camzyos are approved for two different types of cardiac patients 3. BMS Internal Analysis Maximize strong clinical profile Expand prescriber base and further penetrate NYHA Class II Improve patient awareness through DTC (including QoL impact) Increase diagnosis through AI Quarterly U.S. sales, $M1,2 ~75K Prevalent, diagnosed, symptomatic oHCM patients in the U.S. & similar prevalence in Top 5 EU3 NOT FOR PRODUCT PROMOTIONAL USE
Milvexian1,2: Opportunity to expand anticoagulation beyond FXa to benefit millions of patients 17 Anti-platelets4,5 SSP ACS Factor Xa AF4 milvexian ~7.5M patients3 in U.S. with thrombotic diseases need treatment Potential differentiated profile for SSP, ACS, AF Ph3 studies in Secondary Stroke Prevention (SSP), Acute Coronary Syndrome (ACS) & Atrial Fibrillation (AF) Confidence in AF Ph3 supported by: Ph2 study in TKR evaluating 16-fold dose range 100mg BID dose exhibiting comparable efficacy to historical FXa Differentiated dose response for bleeding Potential to be the only Oral FXIa in AF 1. U.S. FDA granted Fast Track Designation to all 3 indications 2. Developed in partnership with J&J Innovative Medicines 3. Decision Resource Group, BMS Internal Analysis 4. Current standard of care for indication(s) 5. FXa not used due to risk of bleeding NOT FOR PRODUCT PROMOTIONAL USE
Focus on disciplined execution How we will deliver 18 Build on our leadership in Oncology, Hematology & Cardiovascular Continue to grow our presence in Immunology & Neuroscience Strategic capital allocation Maximize valuefrom our differentiated pipeline & platforms
Establishing a growing presence in Immunology 19 Addressing diverse immunologic diseases with high unmet need impacting 8M+1 patients Maximize existing core indications Expand indication opportunities of leading marketed products Launch next wave of assets Moderate to Severe Plaque Psoriasis Ulcerative Colitis Rheumatoid Arthritis Crohn’s Disease Psoriatic Arthritis SLE Sjogren’s syndrome Alopecia Areata Not exhaustive of assets, programs, or indications 1. 2023 estimates from Decision Resource Group & BMS Internal Analysis across indications in the U.S. & EU5; SLE: Systemic Lupus Erythematosus cendakimab LPA1 antagonist CD19 NEX T Eosinophilic Esophagitis & Gastroenteritis Idiopathic & Progressive Pulmonary Fibrosis SLE Multiple Sclerosis Others NOT FOR PRODUCT PROMOTIONAL USE
CVS indication-based formulary with 0 step edits Second major PBM secured with one step edit: ESI, 30M lives Sotyktu is a key growth driver to establish leadership in Immunology 20 Expansion opportunities across autoimmune2 Executing launch in psoriasis and broadening access ~6 million adults in the U.S.1 Focus on growing volume & expanding access Psoriatic Arthritis: Shared pathogenesis with psoriasis – 2024/2025 SLE: Substantial need for effective oral options – 2026 Sjogren’s syndrome: Shared pathogenesis with SLE with significant unmet need – 2027 Alopecia Areata3: Significant unmet need in autoimmune hair loss with limited treatment options Ongoing phase III trials with broad applicability and data anticipated in 2024 – 2027 1. Decision Resources Group; BMS Internal Analysis; 2. Years indicate expected data readouts; 3. Phase 2 POC; SLE: Systemic Lupus Erythematosus NOT FOR PRODUCT PROMOTIONAL USE
Potentially differentiated profile Phase 3 registrational trials in IPF & PPF ongoing – data expected 2027/28 LPA1 antagonist has the potential to be the new standard of care in pulmonary fibrosis 21 Significant Unmet need Progressive Pulmonary Fibrosis (PPF) 140K U.S. prevalence1 290K U.S. prevalence1 Idiopathic Pulmonary Fibrosis(IPF) IPF is fatal lung disease with 3–5 year median survival2 Approved therapies have tolerability challenges and do not treat underlying fibrosis LPA1 antagonist – Disease modifying agent andbest-in-class potential >60% reduction in lung-function decline3,4 Differentiated tolerability profile 1. Decision Resource Group; 2. Raghu. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. 3. Corte TJ, et al. Am J Respir Crit Care Med. 2023;207:A2785. 4. Corte TJ, et al. ERS 2023 [Presentation #RCT800]. NOT FOR PRODUCT PROMOTIONAL USE
Potential for massive expansion of cell therapy addressable market Potential transformative efficacy and safety profile to reset immune system Initial in-house clinical data for lupus expected in 2024 | Expanding to myositis, MS, other diseases CD19 NEX T: Potential transformative cell therapy for patients with several severe immunologic diseases 22 Addressable population1 Growing evidence of CAR T-induced immune rest in severe autoimmune diseases, e.g., Durable remission in SLE CD19 NEX T: Best-in-class Breyanzi construct with improved manufacturing focused on scale and reliability Heme malignancy B cell-mediatedAutoimmune 5-10x SLE MS SSc Myositis Other indications 1. Decision Resources Group; SLE: Systemic Lupus Erythematosus, SSc: Systemic Sclerosis, IIM: Idiopathic Inflammatory Myopathies, MS: Multiple Sclerosis NOT FOR PRODUCT PROMOTIONAL USE
Re-establishing Neuroscience across a wide range of conditions with substantial unmet need 23 Substantial unmet need across millions of patients Neuroinflammation Neurodegeneration Neuropsychiatry Multiple Sclerosis Alzheimer’s Disease Parkinson’s Disease ALS eIF2b activator Schizophrenia Schizophrenia (adjunctive) Alzheimer’s disease psychosis Alzheimer’s disease agitation Bipolar I Mood & anxiety disorders Anti-MTBR-Tau FAAH MGLL Not exhaustive of assets, programs, or indications 1. Subject to satisfaction of customary closing conditions; anticipated closing for Karuna Therapeutics in 1H 2024 1 CD19 NEX T TYK2i-CNS KarXT NOT FOR PRODUCT PROMOTIONAL USE
Schizophrenia approval ~1.6M2 treated patients inthe U.S. KarXT1: Starting next year, opportunity for series of indications supporting continued growth 24 1. Subject to satisfaction of customary closing conditions; anticipated closing 1H 2024 1. Subject to satisfaction of customary closing conditions; anticipated closing 1H 2024 1. Subject to satisfaction of customary closing conditions; anticipated closing 1H 2024 1. Subject to satisfaction of customary closing conditions; anticipated closing 1H 2024. 2. DRG – Clarivate, as of July 2023; 3. “Alzheimer’s Disease Association Facts and Figures,” 2023 2024 2025 2026 – 2028 2029+ Adjunctive schizophreniaPhase 3 data Expansion within schizophrenia Pipeline and future indications Alzheimer’s Disease Agitation registrational data >6M3 people living with ADin U.S. Bipolar I Disorderregistrational data Impacts ~1.4M2 patients in U.S. Alzheimer’s disease psychosis registrational data >6M3 people living with ADin U.S. Long-acting injectable NOT FOR PRODUCT PROMOTIONAL USE
Focus on disciplined execution How we will deliver 25 Build on our leadership in Oncology, Hematology & Cardiovascular Continue to grow our presence in Immunology & Neuroscience Strategic capital allocation Maximize valuefrom our differentiated pipeline & platforms
2022 – 2023 2024 – 2025 2026 - 2027 2028 - 2030 Cendakimab Iberdomide LPA1 antagonist KarXT1 Mezigdomide CD19 NEX T Alnuctamab GPRC5D CAR T Milvexian BET inhibitor (986158) Golcadomide AR LDD RYZ1011 MYK-224 BL-B01D11 PRMT5/MTA Inhibitor1 Portfolio evolution: Potential to add 16+ NMEs over decade 26 Cardiovascular Oncology Hematology Immunology New pipeline additions since Jan 2023 NMEs by potential year of first approval Potential for additional 40+ LCM opportunities across these NMEs & approved products 1. Subject to satisfaction of customary closing conditions; anticipated closing of Mirati Therapeutics, Karuna Therapeutics, RayzeBio, & SystImmune in 1H 2024; 2. Approved in 2022 & expected addition to BMS portfolio in 2024Unmarketed products are subject to positive registrational trials and regulatory approval 1,2 Neuroscience recently approved NOT FOR PRODUCT PROMOTIONAL USE
Multiple key pipeline milestones expected in 2024 27 Milestones represent expected data read-outs unless otherwise specified | 1. Week 12 primary endpoint data anticipated 2024/2025 2. Subject to satisfaction of customary closing conditions; anticipated closing for Mirati Therapeutics, Karuna Therapeutics, RayzeBio & SystImmune in 1H 2024 ABECMA 3–5L RRMM (KarMMa-3) approval Cendakimab EoE Ph3 PRMT5/MTA Inhibitor2 MTAP-deleted cancers Ph1 AR LDD mCRPC Ph1 KarXT2 Schizophrenia approval RYZ1012 ES-SCLC Ph1 BL-B01D12 (EGFRxHER3 ADC) NSCLC Ph1 Krazati (KRASG12C Inhibitor)2 1L NSCLC TPS<50% Ph2 2L NSCLC confirmatory Ph3 SOTYKTU1 PsA-2 Ph3 at Wk52 PsA-1 Ph3 at Wk52 CD19 NEX T Severe refractory SLE dose escalation Ph1 OPDUALAG 1L HCC Ph2 1L NSCLC Ph2 ZEPOSIA1 CD Ph3 Induction 1 CD Ph3 Induction 2 NOT FOR PRODUCT PROMOTIONAL USE
Focus on disciplined execution How we will deliver 28 Build on our leadership in Oncology, Hematology & Cardiovascular Continue to grow our presence in Immunology & Neuroscience Strategic capital allocation Maximize valuefrom our differentiated pipeline & platforms
Strategic approach to capital allocation 29 Further diversify our portfolio Strengthen long-term growth profile Strong cash flow generation Balance sheet strength Continued commitment to dividend – 15 consecutive annual increases Industry-leading return of capital over last 3 years Business development Strong investment-grade rating Shareholder distributions
Enhance growth in back half of the decade Business development remains a priority to strengthen the growth profile of the company 30 Focused on licensing, partnerships & bolt-on acquisitions Build depth in existing Therapeutic Areas Maintain financial discipline Enhance presence in emerging Therapeutic Areas Focus on areas of significant unmet need where BMS can lead
We have already executed important deals to strengthen our growth profile 31 Focus on areas of significant unmet need where BMS can lead 1. Subject to satisfaction of customary closing conditions; anticipated closing for Mirati Therapeutics, Karuna Therapeutics, RayzeBio, & SystImmune in 1H 2024 Not exhaustive of assets, programs, or indications 1 1 1 1 Deals over the last six months
Focus on disciplined execution How we will deliver 32 Build on our leadership in Oncology, Hematology & Cardiovascular Continue to grow our presence in Immunology & Neuroscience Strategic capital allocation Maximize valuefrom our differentiated pipeline & platforms
Driving a strong sense of urgency and accountability We are focused on disciplined execution Commercial R&D Manufacturing Accelerate performance for key growth drivers Ensure right level of resourcing Drive top-tier productivity Discontinue lower value programs Accelerate high priority programs Significantly increase cell therapy capacity and improve reliability & cost Robust supply chain capabilities to ensure secure supply and risk mitigation including radiotherapies 33
Reaffirming all financial targets 34 Low-to-mid single-digit revenue CAGR1 from 2020-2025 Low double-digit revenue CAGR1 ex-Rev/Pom from 2020-2025 $8B-$10B growth from in-line brands2 from 2020-2025 >$10B revenue from new product portfolio in 2026 Operating margin target to >37% through 20253 $25B NRA for 9 New Product Portfolio in 2030 Primarily annual Total company revenue guidance Total company line-item guidance Key pipeline events and milestones *See “Forward-Looking Statements and Non-GAAP Financial Information” and “Bristol Myers Squibb Company Reconciliation of Certain GAAP Line Items to Certain Non-GAAP Line Items” 1. At constant exchange rates on a risk-adjusted basis 2. Primarily IO & Eliquis; NRA: Non-Risk Adjusted sales subject to positive registrational trials and health authority approval; Financial projections may contain non promoted sales, BMS promotes only according to label 3. Operating margin >37% through 2025 excludes potential future business development Key targets* Return to historical guidance practice
Executing on our plan to drive sustainable, top-tier long-term growth Revenue, illustrative Navigate transition period Maximize performance through 2025 35 Drive strong commercial execution Launch new medicines Integrate Mirati, Karuna, RayzeBio1 Ensure on-time delivery of late portfolio Deliver against R&D productivity P&L discipline Prosecute early to mid-pipeline Deliver potential from recently acquired assets Continue to enhance pipeline through disciplined BD 1. Subject to satisfaction of customary closing conditions; anticipated closing for Mirati Therapeutics, Karuna Therapeutics & RayzeBio in 1H 2024 Accelerate growth from late 2020s
Our ESG updates and looking ahead 37 ESG Materiality Assessment Results 2022 ESG Report Completed a global, double ESG materiality assessment1 and identified the8 ESG factors that were rated as most “material” by stakeholders Results showed strong alignment of internal and external stakeholders’ priorities On August 23, 2023, published BMS’ 2022 ESG Report,2 providing increased transparency and disclosures 2022 Highlights Include: 58% clinical trial sites in diverse metro areas $1B global spend on diverse-owned businesses 8.2% reduction in greenhouse gas emissions across Scopes 1, 2, & 3 compared to 2021 TOP 8 Material ESG Factors Pricing & Patient Access Product Innovation Patient Safety and Product Quality Ethics & Conduct Long-Term Value Creation Culture and Inclusion & Diversity Climate Change & Emissions Public Health & Public Policy Breakdown:Top ESG Issues by Theme Looking Ahead Evolved ESG Strategy based on double materiality assessment will be shared in 2024 Task Force on Climate-Related Financial Disclosures (TCFD) report published in December 2023 Science-based emissions reduction targets anticipated to be validated by the Science Based Targets Initiative (SBTi) by 2024 $150 million to address health disparities will be provided by end of 2025 1 BMS ESG Materiality Assessment 2 BMS 2022 ESG Report NOT FOR PRODUCT PROMOTIONAL USE
Year-Ended December 31 2020 2021 2021 2022 Total Revenues $42,518 $46,385 $46,159 Gross Profit $30,745 $36,445 $36,022 Specified items (a) $3,300 $603 $356 Gross Profit excluding specified items $34,045 $37,048 $36,378 Marketing, Selling and Administrative $7,661 $7,690 $7,814 Specified items (a) ($279) ($3) ($79) Marketing, Selling and Administrative excluding specified items $7,382 $7,687 $7,735 Research and Development $10,048 $10,195 $9,509 Specified items (a) ($903) ($843) ($308) Research and Development excluding specified items $9,145 $9,352 $9,201 Operating margin 31% 40% 41% Specified items (a) 10% 3% 1% Operating margin excluding specified items (b) 41% 43% 42% Bristol Myers Squibb Company Reconciliation of Certain GAAP Line Items to Certain Non-GAAP Line Items 38 (a): An explanation of these non-GAAP financial measures and a reconciliation to the most directly comparable GAAP financial measure are available on our website at bms.com/investors. (b): Operating margin on Specified Items represents the difference between the GAAP and Non-GAAP operating margin (Unaudited, dollars in millions)
Phase II Phase I Clinical Development Portfolio – Phase I and II 39 ª Anti-CTLA-4 NF Probody® Therapeutic Solid Tumors Lung Cancer Colorectal Cancer ª Anti-Fucosyl GM1^ RR Small Cell Lung Cancer ª Anti-IL-8^ Solid Tumors ª Anti-NKG2A^ Non-Small Cell Lung Cancer ª BET Inhibitor (BMS-986378)^ Solid Tumors ª farletuzumab ecteribulin Ovarian Cancer ª farletuzumab ecteribulin Non-Small Cell Lung Cancer nivolumab+relatlimab Stage IV 1L Non-Small Cell Lung Cancer 1L Hepatocellular Carcinoma AUGTYRO NTRK Pan-Tumor ª BET Inhibitor (BMS-986158) 1L Myelofibrosis BREYANZI RR Follicular Lymphoma (FL) RR Marginal Zone Lymphoma (MZL) RR Mantle Cell Lymphoma (MCL) ª golcadomide RR Non-Hodgkin’s Lymphoma ONUREG Myelodysplastic Syndrome REBLOZYL A-Thalassemia CAMZYOS Heart Failure with preserved Ejection Fraction (HFpEF) ª danicamtiv Dilated Cardiomyopathy ª MYK-224 Obstructive Hypertrophic Cardiomyopathy Heart Failure with preserved Ejection Fraction (HFpEF) ª afimetoran Systemic Lupus Erythematosus SOTYKTU Alopecia Areata Discoid Lupus Erythematosus ª TYK2 Inhibitor (BMS-986322) Moderate-to-Severe Psoriasis ª AHR Antagonist*^ Solid Tumors ª Anti-CCR8^ Solid Tumors ª Anti-ILT4^ Solid Tumors ª AR LDD 1L, 2L Metastatic Castration-Resistant Prostate Cancer ª DGK Inhibitor Solid Tumors ª Helios CELMoD Solid Tumors ª JNK Inhibitor Solid Tumors ª MAGE A4/8 TCER* Solid Tumors ª NME 1 Prostate Cancer ª SHP2 Inhibitor^ Solid Tumors ª TGFβ Inhibitor^ Solid Tumors ª TIGIT Bispecific Solid Tumors Lung Cancer Gastric Cancer ª alnuctamab RR Multiple Myeloma ª Anti-SIRPα Hematologic Malignancies ª BCL6 LDD Lymphoma ª BCMA NKE RR Multiple Myeloma ª BET Inhibitor (BMS-986378)^ RR Non-Hodgkin’s Lymphoma ª CD33-GSPT1 ADC Acute Myeloid Leukemia ª CD33 NKE Acute Myeloid Leukemia ª CK1α Degrader Hematologic Malignancies ª Dual Targeting BCMAxGPRC5D CAR T RR Multiple Myeloma golcadomide^ 1L Diffuse Large B-cell Lymphoma ª GPRC5D CAR T RR Multiple Myeloma ª FXIa Inhibitor Thrombotic Disorders ª Anti-CD40 Autoimmune Disease ª CD19 NEX T Severe Refractory Systemic Lupus Erythematosus ª IL2-CD25 Autoimmune Disease ª NME 2 Autoimmune Disease ª PKCθ Inhibitor Autoimmune Disease ª Anti-MTBR-Tau Alzheimer’s Disease ª eIF2b Activator Neuroscience ª FAAH/MGLL Dual Inhibitor Neuroscience ª TYK2 Inhibitor (BMS-986465) Neuroinflammation diseases Hematology Neuroscience Oncology Immunology CV * Partner-run study NME leading indication ^ Trials exploring various combinations Data as of December 31, 2023
Phase III Clinical Development Portfolio – Phase III Registration US, EU, JP OPDIVO Adjuvant Hepatocellular Carcinoma Peri-adjuvant Muscle-Invasive Urothelial Carcinoma Peri-adjuvant Non-Small Cell Lung Cancer Stage IB-IIIA Adjuvant NSCLC* OPDIVO + YERVOY 1L Hepatocellular Carcinoma 1L Muscle Invasive Urothelial Carcinoma 1L+ Microsatellite Instability High Colorectal Cancer Stage 3 Unresectable Non-Small Cell Lung Cancer OPDUALAG Adjuvant Melanoma ª SC nivolumab + relatlimab + rHuPH20 1L Melanoma ª SC nivolumab + rHuPH20 (multi-indications) 2L Renal Cell Carcinoma ª ABECMA Newly Diagnosed Multiple Myeloma with Suboptimal Response post-ASCT iberdomide ª2L+ Multiple Myeloma Post-Autologous Stem Cell Therapy Maintenance Newly Diagnosed Multiple Myeloma mezigdomide ª2L+ Multiple Myeloma Vd 2L+ Multiple Myeloma Kd REBLOZYL 1L TD Myelofibrosis Associated Anemia 1L NTD Myelodysplastic Syndrome Associated Anemia CAMZYOS Non-Obstructive Hypertrophic Cardiomyopathy milvexian Secondary Stroke Prevention* Acute Coronary Syndrome* ªAtrial Fibrillation* cendakimab ªEosinophilic Esophagitis Eosinophilic Gastroenteritis # LPA1 Antagonist ªIdiopathic Pulmonary Fibrosis (IPF) LPA1 Antagonist Progressive Pulmonary Fibrosis (PPF) ª obexelimab * IgG4-Related Disease SOTYKTU Psoriatic Arthritis Systemic Lupus Erythematosus Sjögren's Syndrome ZEPOSIA Crohn’s Disease AUGTYRO ROS1 NSCLC (EU, JP) NTRK Pan-Tumor (EU) OPDIVO + YERVOY 1L Muscle Invasive Urothelial Carcinoma (US, EU, JP) ABECMA 3-5L Multiple Myeloma (US, EU) BREYANZI 3L+ Chronic Lymphocytic Leukemia (US) RR Follicular Lymphoma (JP) REBLOZYL 1L TD Myelodysplastic Syndrome Associated Anemia (EU, JP) Development Partnerships: ABECMA: 2seventy bio; AHR: Ikena Oncology; farletuzumab ecteribulin: Eisai; rHuPH20: Halozyme; MAGEA4/8 TCER: Immatics; milvexian: J&J Innovative Medicine; OPDIVO, YERVOY, OPDUALAG in Japan: Ono; PKCθ Inhibitor: Exscientia; REBLOZYL: Merck; SHP2 Inhibitor: BridgeBio Pharma; TIGIT Bispecific: Agenus; obexelimab: Zenas BioPharma in Japan, South Korea, Taiwan, HK, Singapore, and Australia 40 Data as of December 31, 2023 Hematology Neuroscience Oncology Immunology CV * # Partner-run study NME leading indication Japan only