8-K
BRISTOL MYERS SQUIBB CO (BMY)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 13, 2025
BRISTOL-MYERS SQUIBB COMPANY
(Exact name of registrant as specified in its charter)
| Delaware | 001-01136 | 22-0790350 |
|---|---|---|
| (State or other jurisdiction of incorporation or organization) | (Commission File Number) | (I.R.S Employer Identification No.) |
Route 206 & Province Line Road, Princeton, New Jersey 08543
(Address of principal executive offices) (Zip Code)
(Registrant’s telephone number, including area code): (609) 252-4621
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, $0.10 Par Value | BMY | New York Stock Exchange |
| 1.000% Notes due 2025 | BMY25 | New York Stock Exchange |
| 1.750% Notes due 2035 | BMY35 | New York Stock Exchange |
| Celgene Contingent Value Rights | CELG RT | New York Stock Exchange |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 7.01 | Regulation FD Disclosure. |
|---|
On January 13, 2025, Bristol-Myers Squibb Company (the “Company”) posted an investor presentation to its website at: www.bms.com/investors/events-and-presentations.html. A copy of the investor presentation is attached as Exhibit 99.1 to this Current Report on Form 8-K.
The information set forth in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise be subject to the liabilities thereof, nor shall it be incorporated by reference into any filing by the Company under the Exchange Act or under the Securities Act of 1933, as amended, whether made before or after the date hereof regardless of any general incorporation language in such filing. The furnishing of this information hereby shall not be deemed an admission as to the materiality of any such information.
| Item 9.01 | Financial Statements and Exhibits. |
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(d) Exhibits
The following exhibits are furnished as part of this Current Report on Form 8-K:
| Exhibit<br><br> <br>No. | Description |
|---|---|
| 99.1 | Investor presentation of Bristol-Myers Squibb Company dated January 13, 2025. |
| 104 | The cover page from this Current Report on Form 8-K formatted in Inline XBRL (included as Exhibit 101). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| BRISTOL-MYERS SQUIBB COMPANY | ||
|---|---|---|
| Dated: January 13, 2025 | By: | /s/ Amy Fallone |
| Name: | Amy Fallone | |
| Title: | Corporate Secretary |
Exhibit 99.1
43rd Annual J.P. Morgan Healthcare Conference January 13th, 2025 Christopher Boerner, Ph.D., Board Chair and Chief Executive Officer
Forward Looking Statements and Non-GAAP Financial Information 2 This presentation (as well as the oral statements made with respect to the 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 reports on Forms 10-Q and 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 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 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 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 available on our website at www.bms.com/investors. Also note that 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 and 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 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.
The next chapter for BMS comes into focus 3 January 2024 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 execution Today Key first and/or best in class medicines driving Growth Portfolio* Entering data-rich period, 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 growth Expanded presence in key TAs Re-established presence in neuroscience with Cobenfy Extended immuno-oncology portfolio durability with Opdivo Qvantig Advanced late-stage assets with significant potential Bolstered financial position Successful integration of strategic acquisitions Achieved majority of ~$1.5 billion productivity program and reinvested savings into high-ROI opportunities Progress towards $10 billion debt pay down commitment1 2024 execution has strengthened our foundation 4 → Stronger portfolio, pipeline & financial flexibility entering 2025 1. Relative to the total debt level as of March 31, 2024
Delivering breakthrough medicines to even more patients even faster and compelling returns to our shareholders Overarching strategic focus: Achieve sustained top-tier growth by end of the decade 5 Focusing on transformational medicines in areas where we have a competitive advantage Driving operational excellence throughout the organization Strategically allocating capital for long-term growth and returns →
Focusing on transformational medicines where we have competitive advantages 6 Key marketed products Key Ph 2/3 programs Investment priorities Oncology/Hematology Protein degradation Cell therapy Complex biologics Radiopharmaceuticals Cardiovascular Thrombosis Cardiomyopathies Heart failure Neuroscience Neuropsychiatry Neurodegeneration Immunology Controlling inflammation Resetting immune memory Promoting homeostasis 21 5 6 8 40 Total
Five products key to Growth Portfolio performance 7 Growth Portfolio expected to exceed 50% of revenues in 2025 *See “Forward-Looking Statements and Non-GAAP Financial Information.”; MDS: myelodysplastic syndrome; MF: myelofibrosis; oHCM: obstructive hypertrophic cardiomyopathy; nHCM: non-obstructive hypertrophic cardiomyopathy; SoC: standard of care; NSCLC: non-small cell lung cancer First–in-class treatment in 1L MDS anemia with broad label Potential MF anemia expansion with Phase 3 data expected in 2025* First-in-class treatment in oHCM nHCM 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 with multiple high potential expansion opportunities Launched late October 2024 First–in-class treatment, now a SoC in 1L melanoma Exploring indication expansions (e.g., 1L NSCLC)
Cobenfy launch off to a strong start with the first indication for schizophrenia… 8 IQVIA Weekly NPA (Rapid) & APLD; Cobenfy’s TRx is overall 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 can’t 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, IL Thanksgiving Christmas & New Years 01 Consistent customer feedback highlights benefits of unique MoA across the three domains of schizophrenia 02 Cobenfy TRx performance is aligned to our expectations and ahead of branded schizophrenia launch benchmarks 03 Medicare & Medicaid coverage currently tracking ahead of expectations 04 Broader Commercial coverage expected in 2H25
…with several potential indications with multi-billion-dollar peak sales over the decade 9 Expected clinical data readout every year through the end of the decade Ongoing registrational study readout Planned registrational study readout Alzheimer’s Disease Cognition >6M1 people living with AD in U.S. 2025 2026 2027 2028 2029 2030+ Alzheimer’s Disease Agitation >6M1 people living with AD in U.S. Bipolar I Disorder Impacts ~1.4M3 patients in U.S. Alzheimer’s Disease Psychosis(ADEPT-1 & 4) >6M1,2 people living with AD in U.S. Adjunctive Schizophrenia (ARISE) Expansion within schizophrenia Alzheimer’s 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. “Alzheimer’s Disease Association Facts and Figures,” 2023. 2. Represents 40% of Alzheimer’s disease 3. DRG – Clarivate, as of July 2023
2025 2025 Entering data rich period with multiple catalysts 10 2025–2027 key milestones* Reblozyl TD MF Associated Anemia (INDEPENDENCE) Opdualag Adjuvant Melanoma (RELATIVITY-098) CAMZYOS nHCM (ODYSSEY) Cobenfy Adjunctive Schizophrenia (ARISE) Cobenfy Alzheimer’s Disease Psychosis (ADEPT-2) CD19 NEX-T Autoimmune Diseases (Breakfree-1 & 2) Krazati 1L NSCLC (TPS <50%) (KRYSTAL-17) EGFR x HER3 ADC Advanced Solid Tumors1 RYZ101 1L ES-SCLC LCM pivotal data 2026 Milvexian ACS & SSP (LIBREXIA) Admilparant IPF (ALOFT-IPF) Iberdomide RRMM (EXCALIBER-RRMM) Mezigdomide RRMM (SUCCESSOR-1 & 2) Arlo-cel RRMM (QUINTESSENTIAL) RYZ101 2L+ GEP-NETs (ACTION-1) NME registrational data Key next wave early-stage data 2026 Sotyktu SLE (POETYK SLE-1 & 2) Cobenfy Alzheimer’s Disease Psychosis (ADEPT-4 & 1) 2026 Golcadomide 1L FL (GOLSEEK-2) MYK-224 HFpEF (AURORA) 2027 AR LDD mCRPC (rechARge) 2027 Anti-MTBR-tau Alzheimer’s Disease (TargetTau-1) 2027 Milvexian AF (LIBREXIA) REBLOZYL 1L NTD MDS Associated Anemia (ELEMENT) Sotyktu Sjogren’s Syndrome (POETYK SjS-1) *See “Forward-Looking Statements and Non-GAAP Financial Information” NME: New Molecular Entity, LCM: Life Cycle Management 1: Trial conducted by SystImmune
CELMoDs: Potential to raise efficacy bar with highly potent protein degraders across hematologic malignacies 11 Potential new oral options with compelling anti-tumor effects and immune stimulation CELMoDs offer a tailored approach of combinable regimens across patient segments2 Multiple Myeloma Iberdomide & Mezigdomide Potential new foundations in the multiple myeloma treatment landscape with four ongoing pivotal trials Iberdomide has the potential to be a new SoC in NDMM as post-transplant maintenance CELMoDs offer potential combinable novel regimens in RRMM including iberdomide with anti-CD38 antibodies & mezigdomide with proteosome inhibitors >30K transplant eligible NDMM patients in U.S./EU1 Phase 3 data expected: 2029 >70K RRMM patients in U.S./EU1 Phase 3 data expected: 2026* Lymphoma Golcadomide Evaluating novel golcadomide combination regimens across aggressive & indolent lymphomas Ongoing pivotal trial evaluating golcadomide + R-CHOP in 1L high-risk LBCL >60K 1L LBCL patients in U.S./EU1 Phase 3 data expected: 2028* *See “Forward-Looking Statements and Non-GAAP Financial Information” 1. Decision Resource 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 diseases 12 *See “Forward-Looking Statements and Non-GAAP Financial Information” 1. Developed in 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 Prevalence Focused on addressing unmet medical need across three large indications1,2 LIBREXIA-STROKE Secondary Stroke Prevention (25mg BID) Combining with dual antiplatelet therapy FXa’s not used due to excess bleeding risk Potential for improved efficacy (e.g., stroke) without increasing bleeding risk ~1.3 million patients in U.S./EU3 Phase 3 data expected: 2026* LIBREXIA-ACS Acute Coronary Syndrome (25mg BID) Similar underlying pathophysiology and treatment as stroke FXa’s not used due to excess bleeding risk Potential for improved efficacy (e.g., CV death, MI) without increasing bleeding risk ~2 million patients in U.S./EU3 Phase 3 data expected: 2026* LIBREXIA-AF Atrial Fibrillation (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 risk ~14 million patients in U.S./EU4 Phase 3 data expected: 2027* FXla inhibition offers promising next-generation anticoagulant paradigm to improve patient care → → →
Admilparant (LPA1 antagonist): Potential to transform the treatment of pulmonary fibrosis 13 ALOFT-IPF & ALOFT–PPF2: Phase 3 registrational studies following a robust Phase 2 program Significant unmet need IPF & PPF are fatal lung diseases with 3–5 years median survival1 Patients continue to experience progressive decline in lung function on approved therapies with limited treatment adherence due to tolerability U.S./EU prevalence3: IPF: 233K, PPF: 485K Pulmonary Fibrosis market: >$4 billion in sales in 20234 Clinical rationale Deliver a new product with potentially 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 PPF5,6 Phase 3 ALOFT-IPF & ALOFT-PPF ongoing Phase 3 data expected: 2026*/2028* *See “Forward-Looking Statements and Non-GAAP Financial 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. ERS 2023 [Presentation #RCT800]; IPF = Idiopathic pulmonary fibrosis; PPF = Progressive Pulmonary Fibrosis Potential to be first and best-in-class, redefining the standard of care in pulmonary fibrosis → →
Upcoming launch catalysts build upon existing portfolio andwill further strengthen our growth profile 14 2028–2030 2026 Breyanzi MZL 3L+ Camzyos nHCM Cobenfy Adjunctive Schizophrenia Opdivo HCC Adjuvant Opdivo+chemo Peri-adjuvant MIUC Reblozyl MF anemia 1L+ Sotyktu PsA 2027 Cobenfy Alzheimer’s Disease Psychosis Krazati CRC 2L Opdualag Adjuvant Stage 3–4 Melanoma Reblozyl Alpha Thalassemia2 iberdomide RRMM mezigdomide RRMM obexelimab IgG4-Related Diseases2 RYZ101 GEP-NETs (SSTR+) Cobenfy Alzheimer’s Disease Agitation Cobenfy Alzheimer’s Disease Cognition Cobenfy Autism Irritability Cobenfy Bipolar I Disorder admilparant PPF arlo-cel MM 2L+ CD19 NEX-T Auto-Immune Indications admilparant IPF anti-CCR8 Solid Tumors AR LDD Prostate Cancer arlo-cel MM 4L+ Sotyktu SLE Reblozyl MDS 1L NTD anemia Sotyktu Sjogren’s Syndrome milvexian Atrial Fibrillation milvexian SSP RYZ101 Breast Cancer 3L+ E+H2- SSTR+ RYZ101 SCLC 1L ES (SSTR+) golcadomide LBCL (high-risk) 1L HELIOS CELMoD Solid Tumors milvexian ACS MYK-224 HFpEF Krazati NSCLC 1L KRAS (TPS <50%) Nivo+Rela HD+Chemo NSCLC 1L Krazati NSCLC 1L KRAS (TPS ≥50%) EGFR x HER3 ADC Additional Solid Tumors golcadomide FL 3L+ iberdomide NDMM post-HSCT maintenance atigotatug SCLC 1L ES BCMA x GPRC5D dual CAR-T RRMM CD19 NEX-T SLE Severe Refractory EGFR x HER3 ADC Solid Tumors PRMT5i Solid Tumors 2025 Opdivo + Yervoy CRC 1L+ MSI High Opdivo + Yervoy 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 immuno-oncology franchise into early 2030s; 2. Ex-US study Currently marketed Growth Portfolio Growth Portfolio LCM NME NME LCM → 1
Continuing to drive operational excellence 15 Note: See “Forward-Looking Statements and Non-GAAP Financial Information” Leveraging technology and AI across the organization to accelerate pace of innovation, drive operational excellence and reduce cost base Annualized ~$1.5B in cost savings to be realized by the end of 2025 Reinvesting savings in high return growth initiatives Continuing to review cost structure Evolving our organization Prioritizing the highest value programs Raising the probability of success from first-in-human to approval Reducing cycle times to bring medicines to patients faster Improving R&D productivity Increasing efficiency Maintaining a highly patient-centric approach Greater focus on accountability and acting with sense of urgency Streamlining the organization and simplifying ways of working
Investments 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 years1,4 Balance sheet strength Maintaining a strong balance sheet that provides strategic flexibility Planned debt repayment of $10B by 1H’265 Strong long-term investment grade credit ratings Returning capital to shareholders Solid track record of returning capital to shareholders through ~$14B in dividends and ~$16B in share repurchases over the past 3 years1 93 consecutive years of dividend payments6 Strategically allocating capital for long-term growth 16 1. 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 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 company
Reshaping BMS to deliver sustained top-tier growth & long term shareholder returns 17 Focusing on transformational medicines 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 TAs Potential 10+ NMEs & 30+ major LCM indications in 2025–2030* Increased strategic flexibility resulting from financial discipline Increasing conviction in ability to deliver top-tier growth → *See “Forward-Looking Statements and Non-GAAP Financial Information”
(Unaudited, dollars in millions) Three Months Ended December 31, 2021 Year Ended December 31, 2022 Year Ended December 31, 2023 Nine Months Ended September 30, 2024 Three Years Ended September 30, 2024 Research and development $ 2,518 $9,509 $9,299 $7,968 $29,294 Specified items(a) - 308 187 974 1,469 Research and Development excluding specified items $2,518 $9,201 $9,112 $6,994 $27,825 Bristol Myers Squibb Company Reconciliation of Certain GAAP Line 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 bms.com/investors 19
10 Growth Portfolio Legacy Portfolio 1. Other Growth Brands: Onureg, Inrebic, Nulojix, Empliciti, & Royalty revenues Other Growth Brands1 Other Mature Brands
2024 environmental, social, and governance progress 21 Named to the 2023 Dow Jones Sustainability™ World Indices1 ASPIRE 10-year strategy announced, expanding access to patients in LMICs 6 consecutive years of beingawarded a top score on Disability Equality Index® SBTi validation of our near-term and long-term net-zero targets ATOM coalition collaboration announced to provide access to our immuno-oncology therapies like OPDIVO® in select LMICs ESG strategy Advancing patienthealth around the world Fostering a high-performing & inclusive global workforce Reducing our environment impact One of America’s 100 Most JUST Companies, jumping from 349th position to 100th 2024 Climate Change Report – Published Access to Medicine Index (ATMI) BMS climbed two spots to 13th out of 20 since 2022 10 consecutive years of being included in the FTSE4Good Index Series 1. Index recognizes progress increasing workforce representation, reducing environmental impact, enhancing data privacy and cyber security programs, establishing principles for responsible artificial intelligence
Clinical Development Portfolio — Phase I and II 22 Krazati 1L Non-Small Cell Lung Cancer PD-L1<50% Breyanzi RR Marginal Zone Lymphoma Golcadomide RR Follicular Lymphoma Arlocabtagene autoleucel (GPRC5D CAR T) ª RR Multiple Myeloma Reblozyl A-Thalassemia MYK-224 ª Heart Failure with preserved Ejection Fraction Obstructive Hypertrophic Cardiomyopathy afimetoran ª Systemic Lupus Erythematosus BMS-986322 (TYK2 Inhibitor) ª Moderate-to-Severe Psoriasis Sotyktu Discoid Lupus Erythematosus Anti-MTBR Tau ª Alzheimer’s Disease Anti-CCR8 ª Solid Tumors BMS-986460 ª Prostate Cancer BMS-986463 ª Solid Tumors BMS-986484 ª Solid Tumors BMS-986490 ª Solid Tumors FAK CELMoD ª Solid Tumors IKZF-PD CELMoD ª Solid Tumors izalontamab brengitecan (EGFRxHER3 ADC) ª 1L Non-Small Cell Lung Cancer* Solid Tumors* Metastatic Non-Small Cell Lung Cancer Helios CELMoD ª Solid Tumors JNK Inhibitor ª Solid Tumors KRASG12D Inhibitor ª Solid Tumors PRMT5 Inhibitor ª Solid Tumors RYZ101 Extensive Stage Small Cell Lung Cancer HR+/HER2- Unresectable Metastatic Breast Cancer RYZ801 ª Hepatocellular Carcinoma SOS1 Inhibitor ª Solid Tumors BCL6 LDD Lymphoma CD33-GSPT1 ADC ª Acute Myeloid Leukemia CD33 NKE ª Acute Myeloid Leukemia CK1α Degrader ª Hematologic Malignancies Dual Targeting BCMAxGPRC5D CAR T ª RR Multiple Myeloma HbF Activating CELMoD ª Sickle Cell Disease BMS-986454 ª Autoimmune Disease CD19 NEX-T Autoimmune Diseases ª Severe Refractory Systemic Lupus Erythematosus IL2-CD25 ª Autoimmune Disease PKCθ Inhibitor ª Autoimmune Disease BMS-986495 ª Neurodegenerative Diseases CD19 NEX-T Multiple Sclerosis eIF2B Activator ª Alzheimer’s Disease FAAH/MGLL Dual Inhibitor ª Neurodegenerative Diseases TRPC4/5 Inhibitor ª Mood and Anxiety Disorders BMS-986465 (TYK2 Inhibitor) ª Neuroinflammation Disorders Data as of Jan 13th, 2025 Phase I Phase II Hematology Neuroscience Oncology Immunology CV * Partner-run study NME leading indication
Clinical Development Portfolio — Phase III 23 AR LDD ª Metastatic Castration-Resistant Prostate Cancer Atigotatug (Anti-Fucosyl GM1) + nivolumab ª 1L Extensive Stage Small Cell Lung Cancer Krazati 1L Non-Small Cell Lung Cancer PD-L1≥50% 2L Colorectal Cancer Nivolumab + Relatlimab HD ª 1L Non-Small Cell Lung Cancer OPDIVO Adjuvant Hepatocellular Carcinoma Peri-adjuvant Muscle-Invasive Urothelial Carcinoma Stage IB-IIIA Adjuvant Non-Small Cell Lung Cancer* OPDUALAG Adjuvant Melanoma RYZ101 ª 2L+ SSTR2+ Gastroenteropancreatic Neuroendocrine Tumors SC nivolumab + relatlimab + rHuPH20 ª 1L Melanoma Golcadomide ª High Risk 1L Large B-cell Lymphoma (Arlocabtagene autoleucel) (GPRC5D CAR T) 2–4L Multiple Myeloma Iberdomide ª 2L+ Multiple Myeloma Post-ASCT Maintenance Newly Diagnosed Multiple Myeloma Mezigdomide 2L+ Multiple Myeloma Kd ª 2L+ Multiple Myeloma Vd Reblozyl 1L TD Myelofibrosis Associated Anemia 1L NTD Myelodysplastic Syndrome Associated Anemia CAMZYOS Non-Obstructive Hypertrophic Cardiomyopathy Milvexian Acute Coronary Syndrome* Atrial Fibrillation* Secondary Stroke Prevention* Cendakimab ª Eosinophilic Esophagitis Eosinophilic Gastroenteritis # Admilparant ª Idiopathic Pulmonary Fibrosis LPA1 Antagonist Progressive Pulmonary Fibrosis Obexelimab ª IgG4-Related Disease Sotyktu Psoriatic Arthritis Sjögren's Syndrome Systemic Lupus Erythematosus Cobenfy Adjunctive Schizophrenia Psychosis in Alzheimer’s Disease AUGTYRO ROS1 NSCLC (EU) NTRK Pan-Tumor (EU, JP) OPDIVO Peri-adjuvant Non-Small Cell Lung Cancer (EU) OPDIVO+YERVOY 1L Hepatocellular Carcinoma (US, EU, JP) 1L+ Microsatellite Instability High Colorectal Cancer (JP) OPDIVO QVANTIG ª 2L Renal Cell Carcinoma (EU) Breyanzi RR Follicular Lymphoma (EU) Development Partnerships: AUGTYRO: Zai Lab; izalontamab brengitecan (EGFRxHER3 ADC): SystImmune; Cobenfy: Zai Lab; Krazati: Zai Lab; milvexian: Johnson & Johnson; obexelimab: Zenas BioPharma; OPDIVO, YERVOY, OPDUALAG: Ono; PKCθ Inhibitor: Exscientia; Reblozyl: Merck; rHuPH20: Halozyme Data as of Jan 13th, 2025 Phase III Registration US, EU, JP Hematology Neuroscience Oncology Immunology CV * Partner-run study NME leading indication # Japan only