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Not for Product Promotional Use Q3 2026 Results October 29, 2026
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Not for Product Promotional Use Q3 2026 Results Forward Looking Statements and Non-GAAP Financial Information 2 This presentation (as well as the oral statements made with respect to information contained herein) contains statements about Bristol-Myers Squibb Company’s (the “Company”) future financial results, plans, business development strategy, development or expansion of manufacturing facilities, 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, government actions, agreements and regulations, including with respect to pricing controls and market access and the imposition of new tariffs, trade restrictions and export regulations, including the potential for international reference pricing and most-favored nation drug pricing for our products, (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, (viii) political and financial instability, including changes in general economic conditions, and (ix) risks related to the use of artificial intelligence or other emerging technologies in various facets of the company's operations, including partnerships related to the use of, or the sharing of such technologies with third parties, which may exacerbate competitive, regulatory, litigation, cybersecurity, and other risk. 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 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 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. Certain information presented in the accompanying presentation may not add due to the use of rounded numbers.
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3 Q3 2026 Results Chris Boerner, PhD Board Chair and Chief Executive Officer
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Not for Product Promotional Use Q3 2026 Results Q3 2026 Performance *See “Forward-Looking Statements and Non-GAAP Financial Information” 1. Not an exhaustive list of assets, programs, or indications $6.9 $7.7 Q3 2025 Q3 2026 $ in billions 4 Growth Portfolio Revenues Key Milestones1 +12%; +12% Ex-FX* Diverse portfolio of growth drivers Regulatory Approvals •Camzyos expanded to pediatric oHCM •Zenbexus in multiple myeloma CELMoDs Upcoming Newsflow •Zenbexus RRMM PFS Phase 3 data at ASH •Golcadomide 1L FL Phase 2 data at ASH •Mezigdomide PDUFA: May 13, 2027 Positive Pivotal Data Readouts Achieved •Zenbexus PFS in RRMM •Admilparant in IPF •RYZ101 in GEP-NETs •Arlo-cel in RRMM Expanding U.S. Manufacturing Footprint •Houston manufacturing campus •Indiana radiopharmaceutical manufacturing facility
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Q3 2026 Results Not for Product Promotional Use Significant data expected in 2026…and beyond* NME registrational data 2026 •Admilparant IPF (ALOFT-IPF) (Oct ’26) •Arlo-cel 4L+ MM (QUINTESSENTIAL) (Sept ’26) •Iberdomide RRMM PFS (EXCALIBER-RRMM) (Oct ’26) •Mezigdomide RRMM (SUCCESSOR-2) (Mar ’26) •Milvexian SSP (LIBREXIA-STROKE1) •RYZ101 2L+ GEP-NETs (ACTION-1) (Oct ’26) 2027 •Atigotatug + nivolumab 1L ES-SCLC (TIGOS) •Golcadomide High-Risk 1L LBCL (GOLSEEK-1) •Milvexian AF (LIBREXIA-AF1) 2028 •Iza-bren EGFRm NSCLC (IZABRIGHT-Lung01) •Pumitamig 1L ES-SCLC (ROSETTA-Lung-012) •Zola-cel SLE (Breakfree-SLE) LCM pivotal data 2026 •Sotyktu SLE (POETYK SLE-1 & 2) 2027 •Admilparant PPF (ALOFT-PPF) •Cobenfy AD Psychosis (ADEPT) •Cobenfy Bipolar-I (BALSAM-1 & 2) •Mezigdomide RRMM (SUCCESSOR-1) •Sotyktu Sjogren’s Disease (POETYK SjS-1) 2028 •Arlo-cel 2-4L MM (QUINTESSENTIAL-2) •Cobenfy AD Agitation (ADAGIO-2) •Cobenfy AD Cognition (MINDSET-1 & 2) •Cobenfy Adjunctive Bipolar-I (BALSAM-4) •Golcadomide 2L+ FL (GOLSEEK-4) •Krazati 1L NSCLC (KRYSTAL-4) •Krazati 1L NSCLC PD-L1 ≥50% (KRYSTAL-7) •Reblozyl 1L NTD MDS Associated Anemia (ELEMENT) Key next wave early-stage data 2026 •BCMAxGPRC5D dual-targeting CAR T RRMM •Golcadomide 1L FL (GOLSEEK-2) •Imzokitug (anti-CCR8) Solid Tumors •Delocamten (MYK-224) HFpEF (AURORA) •Navlimetostat (PRMT5 inhibitor) Solid Tumors •Pumitamig Solid Tumors2 •Zola-cel Autoimmune Diseases (Breakfree-1 & 2) 2027 •Moponetug (anti-MTBR-tau) Alzheimer’s Disease (TargetTau-1) •Irafamdastat (FAAH/MAGL) AD Agitation (BALANCE-AAD-1) •Irafamdastat (FAAH/MAGL) MS Spasticity (BALANCE-MSS-1) *See “Forward-Looking Statements and Non-GAAP Financial Information”, NME: New Molecular Entity, LCM: Life Cycle Management; 1. Trial conducted by Johnson & Johnson; 2. Trial conducted by BioNTech. Studies shown with dates in parenthesis have reported readouts 5
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Q3 2026 Results Not for Product Promotional Use Key Priorities Through Year-End and Beyond* Sustain Growth Portfolio momentum 8 medicines annualizing at >$1B, providing a broad base of growth drivers Solidifying the Growth Profile Filings, approvals and launches, as exemplified by Zenbexus, to bring new medicines to patients and solidify our growth profile Continue rewiring how we operate R&D rigor, driving productivity, and financial discipline enable us to invest in the Growth Portfolio, pursue BD, and return cash to shareholders 6 *See “Forward-Looking Statements and Non-GAAP Financial Information”
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7 Q3 2026 Results David Elkins Executive Vice President and Chief Financial Officer
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Q3 2026 Results Not for Product Promotional Use $ in billions Growth Portfolio continues to drive revenues Other Growth Brands1 Growth Portfolio Legacy Portfolio Other Mature Brands $6.9 $7.7 5.4 5.4 Q3 2025 Q3 2026 $12.2 $13.1 +12% YoY +12% Ex-FX* 8 *See “Forward-Looking Statements and Non-GAAP Financial Information”; 1. Other Growth Brands: Abecma, Augtyro, Empliciti, Inrebic, Nulojix, Onureg & Royalty Revenues, including royalties received from Merck on Winrevair
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Not for Product Promotional Use Q3 2026 Results Q3 2026 Oncology product summary *See “Forward-Looking Statements and Non-GAAP Financial Information”; 1. Abraxane: Q3 2026 WW Sales $65M - YoY% (13%), (12%) Ex-FX* Global Net Sales1 $M YoY % Ex-FX* % $2,374 (6%) (6%) $793 +7% +8% $367 +23% +23% $334 >200% >200% $58 +10% +10% Opdivo •Remains an important revenue contributor to the Growth Portfolio and continues to deliver value to patients 9 Qvantig •Continued global growth is driven by meaningful convenience to patients and healthcare systems Opdualag •Growth reflects strong demand and established position as a standard of care in 1L melanoma
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Not for Product Promotional Use Q3 2026 Results Global Net Sales1 $M YoY % Ex-FX* % $750 +22% +22% $526 +46% +48% $303 (47%) (47%) $130 (81%) (80%) Q3 2026 Hematology product summary *See “Forward-Looking Statements and Non-GAAP Financial Information”; 1. Abecma: Q3 2026 WW Sales $76M - YoY% (44%), (43%) Ex-FX*; Sprycel: Q3 2026 WW Sales $73M - YoY% (38%), (38%) Ex-FX*; 2. In the U.S., generic lenalidomide products are no longer volume-limited as of January 31, 2026; 3. In the U.S., generic pomalidomide entered in March of 2026 Reblozyl •Growth driven by continued global demand across MDS-associated anemia 10 3 2 Breyanzi •Continued strong demand as the leading CD19 directed CAR T across B-cell malignancies, focused on growing adoption in the community outpatient setting
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Not for Product Promotional Use Q3 2026 Results Q3 2026 Cardiovascular & Immunology product summary Global Net Sales (Cardiovascular) $M YoY % Ex-FX* % $4,690 +25% +26% $420 +42% +42% *See “Forward-Looking Statements and Non-GAAP Financial Information” Eliquis •Continued U.S. demand growth and market share gains Camzyos •Continued strong global demand and market penetration in oHCM •Strong launch momentum outside the U.S. 11 Global Net Sales (Immunology) $M YoY % Ex-FX* % $983 +2% +2% $100 +26% +25% Sotyktu •Continued engagement with the rheumatology community ahead of pivotal SLE and SjD readouts
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Not for Product Promotional Use Q3 2026 Results Q3 2026 Neuroscience product summary Global Net Sales $M YoY % Ex-FX* % $168 +5% +5% $57 +33% +33% Cobenfy •Potential new indications to drive next wave of growth •Improving patient experience through prescriber education emphasizing optimized dose utilization *See “Forward-Looking Statements and Non-GAAP Financial Information” 12
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Not for Product Promotional Use Q3 2026 Results US GAAP Non-GAAP $ in billions, except EPS Q3 2026 Q3 2025 Q3 2026 Q3 2025 Total Revenues, net 13.1 12.2 13.1 12.2 Gross Margin %1 68.3% 71.9% 68.4% 72.9% Operating Expenses2 4.1 4.3 4.1 4.2 Acquired IPR&D 1.6 0.6 1.6 0.6 Amortization of Acquired Intangibles 0.5 0.8 - - Effective Tax Rate 14.8% 29.5% 14.1% 22.3% Diluted EPS 1.05 1.08 1.35 1.63 Diluted Shares Outstanding (# in millions) 2,053 2,039 2,053 2,039 Q3 2026 Financial Performance GAAP Non-GAAP* Diluted EPS Impact from Acquired IPR&D3 (0.58) (0.20) (0.58) (0.20) *See “Forward-Looking Statements and Non-GAAP Financial Information”; 1. Gross Margin = Revenue less COGS as a percentage of Revenue; 2. Operating Expenses = SG&A and R&D; 3. Represents the net impact from Acquired IPRD & licensing income 13
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Not for Product Promotional Use Q3 2026 Results Strategic approach to Capital Allocation 1. Cash includes cash, cash equivalents and marketable debt securities; 2. Subject to Board approval Cash flow from Operations $B 14 $6.3 $2.0 $1.1 $3.4 $4.2 Q3 2025 Q4 2025 Q1 2026 Q2 2026 Q3 2026 $B Q3 2026 Total Cash1 ~$13.0 Total Debt ~$42.9 Business Development •Pursue opportunities and partnerships to diversify portfolio & strengthen long-term outlook Balance Sheet Strength •Strong balance sheet affords financial flexibility •Maintain strong investment-grade credit rating Returning Cash to Shareholders •Remain committed to our dividend2 •~$5B share repurchase authorization remaining as of September 30, 2026
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Not for Product Promotional Use Q3 2026 Results 2026 Guidance* 15 *The Company does not reconcile forward-looking non-GAAP measures. See “Forward-Looking Statements and Non-GAAP Financial Information”; 2026 Guidance excludes the impact of any potential strategic acquisitions, divestitures, specified items that have not yet been identified and quantified, and the impact of future Acquired IPRD charges and licensing income incurred after September 30, 2026; 1. Guidance provided in July was calculated based on mid-July foreign exchange rates; Guidance provided in October was calculated based on mid-October foreign exchange rates; 2. Operating Expenses = SG&A and R&D Non-GAAP1 July (Prior) October (Updated) Total FY Revenues (Reported & Ex-FX) ~$49.0 - $50.0B ~$49.75 - $50.25B Gross Margin % ~69-70% No change Operating Expenses2 ~$16.5B No change Other Income/ (Expense) ~($700M) ~($650M) Tax Rate ~18% No change Diluted EPS $6.75 - $7.00 $6.35 - $6.55 Acquired IPRD Charge & Licensing Income Included in Diluted EPS ($0.02) ($0.60) •FY revenue increase vs. prior guidance reflects year-to- date strength: •Continued Growth Portfolio strength •3% to 5% decline in Legacy Portfolio •20% to 25% growth in WW Eliquis revenue •Gross margin reflects impact of product mix •Operating expenses increase reflects growth-oriented initiatives •OI&E reflects favorable net interest •Updated diluted EPS guidance incorporates $0.58 impact from Acquired IPRD and Licensing Income in Q3 Diluted weighted-average shares outstanding of 2,051 million were used to calculate 2026 diluted EPS guidance Key Highlights
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Q3 2026 Results Not for Product Promotional Use Chris Boerner, PhD Board Chair, Chief Executive Officer David Elkins Executive VP , Chief Financial Officer Adam Lenkowsky Executive VP , Chief Commercialization Officer Cristian Massacesi, MD Executive VP , Chief Medical Officer, Global Drug Development Q3 2026 Results Q&A
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Q3 2026 Results Not for Product Promotional Use Clinical Development Portfolio — Phase I and II 17 BMS-986460^ Prostate Cancer BMS-986488+ Solid Tumors BMS-986500+ Solid Tumors BMS-986506+ Solid Tumors BMS-986517 Solid Tumors BMS-986523 Solid Tumors BMS-986525 R/R Small Cell Lung Cancer BMS-986548 Solid Tumors CD70 HD Allo CAR T Clear Cell Renal Cell Carcinoma IKZF Pan-Degrader+ Solid Tumors imzokitug Solid Tumors iza-bren Solid Tumors pumitamig 1L Hepatocellular Carcinoma 1L Renal Cell Carcinoma RYZ101 SSTR+ HR+/HER2- Unresectable Metastatic Breast Cancer RYZ401 SSTR+ Solid Tumors RYZ801 GPC3+ Hepatocellular Carcinoma WEE1 CELMoD Solid Tumors Data as of October 29, 2026 Phase I BCL6 LDD Lymphoma tunlu-cel (Dual Targeting BCMAxGPRC5D CAR T) R/R Multiple Myeloma mezigdomide + elranatamab R/R Multiple Myeloma BMS-986454 Rheumatoid Arthritis BMS-986485 Autoimmune Diseases CD19 HD Allo CAR T Autoimmune Diseases CD19 in-vivo CAR T Autoimmune Diseases CD19 TCE Autoimmune Diseases zola-cel Idiopathic Inflammatory Myopathies Rheumatoid Arthritis BMS-986521 Neuropsychiatric Disorders BMS-986533 Neurodegenerative Diseases KarXT Long-Acting Injectable Schizophrenia zola-cel Multiple Sclerosis Myasthenia Gravis Phase II Hematology ImmunologyOncology NeuroscienceCardiovascular imzokitug + pumitamig 1L Non-Small Cell Lung Cancer iza-bren 1L Triple-Negative Breast Cancer ‡ Post-IO Metastatic Urothelial Cancer ‡ navlimetostat 1L Non-Small Cell Lung Cancer ‡ 1L Pancreatic Ductal Adenocarcinoma ‡ 2L Non-Small Cell Lung Cancer Solid Tumors OPDIVO QVANTIG + YERVOY 1L Non-Small Cell Lung Cancer ‡ pumitamig 1L Gastric Cancer‡ 2L Non-Small Cell Lung Cancer* arlo-cel 4L+ Multiple Myeloma‡ golcadomide 1L Follicular Lymphoma HbF Activating CELMoD Sickle Cell Disease delocamten Heart Failure with Preserved Ejection Fraction zola-cel Autoimmune Cytopenia Systemic Lupus Erythematosus‡ evifacotrep Mood and Anxiety Disorders irafamdastat Alzheimer’s Disease Agitation Multiple Sclerosis Spasticity moponetug Alzheimer’s Disease * Partner-run study; NME leading indication; + CELMoD; ^ LDD; ‡Registrational
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Q3 2026 Results Not for Product Promotional Use Clinical Development Portfolio — Phase III Development Partnerships: COBENFY (KarXT): Zai Lab; imzokitug + nivolumab, nivolumab + relatlimab HD, OPDIVO QVANTIG, YERVOY: Ono; iza-bren: SystImmune; milvexian: Johnson & Johnson; obexelimab: Zenas BioPharma; pumitamig (BNT327/BMS-986545): BioNTech; REBLOZYL: Merck; BMS-986485: Hengrui Pharma 18 Data as of October 29, 2026 Phase III atigotatug + nivolumab 1L Extensive-Stage Small Cell Lung Cancer iza-bren 1L EGFR-mutated Non-Small Cell Lung Cancer EGFR-mutated Post-TKI Non-Small Cell Lung Cancer KRAZATI 1L Non-Small Cell Lung Cancer 1L Non-Small Cell Lung Cancer PD-L1≥50% nivolumab + relatlimab HD 1L Non-Small Cell Lung Cancer PD-L1≥1% pumitamig 1L Extensive-Stage Small Cell Lung Cancer* 1L Microsatellite Stable Colorectal Cancer 1L Non-Small Cell Lung Cancer* 1L Non-Small Cell Lung Cancer PD-L1≥50% 1L Triple-Negative Breast Cancer* Stage III Non-Small Cell Lung Cancer RYZ101 2L+ SSTR2+ Gastroenteropancreatic Neuroendocrine Tumors arlo-cel 2-4L Multiple Myeloma golcadomide 2L+ Follicular Lymphoma High Risk 1L Large B-cell Lymphoma ZENBEXUS (iberdomide) 2L+ Multiple Myeloma Post-ASCT Maintenance Newly Diagnosed Multiple Myeloma mezigdomide 2L+ Multiple Myeloma Vd REBLOZYL 1L NTD Myelodysplastic Syndrome-Associated Anemia milvexian Atrial Fibrillation* Secondary Stroke Prevention* admilparant Idiopathic Pulmonary Fibrosis Progressive Pulmonary Fibrosis SOTYKTU Sjögren’s Disease Systemic Lupus Erythematosus zola-cel Systemic Sclerosis COBENFY Adjunctive Bipolar-I Mania Alzheimer’s Disease Agitation Alzheimer’s Disease Cognition Alzheimer’s Disease Psychosis Bipolar-I Mania Pediatric Autism Irritability Registration US, EU, JP mezigdomide 2L+ Multiple Myeloma Kd (US, EU, JP) REBLOZYL 1L TD Myelofibrosis-Associated Anemia (US) obexelimab IgG4-Related Disease (JP) * Partner-run study; NME leading indication Hematology ImmunologyOncology NeuroscienceCardiovascular
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Q3 2026 Results Not for Product Promotional Use Q3 2026 Changes to the Development Pipeline 19 Phase I Phase II Phase III Registrational Submissions New or Phase Transition BMS-986548 in Solid Tumors CD70 HD Allo CAR T in ccRCC BMS-986485 in Autoimmune Diseases evifacotrep in Mood & Anxiety Disorders HbF Activating CELMoD in Sickle Cell Disease obexelimab in IgG4-RD (JP) Approvals Removed BMS-986495* CD33-GSPT1 DAC OPDIVO in Adjuvant HCC ZENBEXUS in 2L+ MM (US) Data as of October 29, 2026 Hematology ImmunologyOncology NeuroscienceCardiovascular * Partner-run study NME leading indication
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Q3 2026 Results Not for Product Promotional Use Q3 2026 Opdivo Sales Mix Note: percentages are approximate 20 28% 20% 20% 20% 13% U.S. Sales Mix 20% 20% 24% 7% 29% Ex-U.S. Sales Mix
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Q3 2026 Results Not for Product Promotional Use Other NOACsWarfarinEliquis 76.1% 77.9% 6.2% 5.1% 17.7% 17.0% Q3 2025 Q3 2026 NBRx Share – US 69.9% 71.8% 9.6% 8.8% 20.5% 19.5% Q3 2025 Q3 2026 TRx Share – US Data Source: IQVIA Xponent data via CSCAN; Q3'26 reflects Jul–Aug 2026 actuals; Sep’26 not yet reported Q3 2026 Eliquis NBRx/TRx Share 21
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Q3 2026 Results Not for Product Promotional Use Composition of Other Growth & Other Legacy Products Other Growth Products •Abecma •Augtyro •Empliciti •Inrebic •Nulojix •Onureg •Zenbexus •3rd Party Royalty Revenue1 Other Legacy Products •Idhifa •Istodax •Thalomid •Kenalog •Vidaza •Baraclude •Other Mature Brands 22 1. Includes royalties received from Merck on Winrevair
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Q3 2026 Results Not for Product Promotional Use 23 Q3 2026 key clinical trials update •Krazati •Opdivo •atigotatug •iza-bren •navlimetostat •nivo+rela HD •pumitamig •RYZ101 •Reblozyl •Zenbexus •arlo-cel •mezigdomide •golcadomide •Sotyktu •admilparant •obexelimab •zola-cel •delocamten •milvexian Oncology Hematology Immunology Cardiovascular Neuroscience •Cobenfy •irafamdastat •moponetug
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Q3 2026 Results Not for Product Promotional Use 24 Krazati (KRASG12C inhibitor) Indication 1L NSCLC PD-L1≥50% (with KRASG12C mutation) 1L NSCLC (with KRASG12C mutation) Phase/Study Phase II/III – KRYSTAL-7 Phase III – KRYSTAL-4 # of Patients N = 626 N = 630 Design •Adagrasib 400 mg BID + pembrolizumab 200 mg Q3W •Pembrolizumab 200 mg IV Q3W •Adagrasib 400 mg BID + pembrolizumab 200 mg Q3W + chemotherapy Q3W •Placebo BID + pembrolizumab 200 mg Q3W + chemotherapy Q3W Endpoints •Primary: OS, PFS •Primary: OS, PFS Status •Recruiting •Projected data readout 2028 •Recruiting •Projected data readout 2028 CT Identifier NCT04613596 NCT06875310
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Q3 2026 Results Not for Product Promotional Use 25 Opdivo (anti-PD1) Indication 1L NSCLC SC + IV Phase/Study Phase II – CheckMate -1533 # of Patients N = 76 Design •Opdivo Qvantig + Yervoy + chemotherapy Dose 1 •Opdivo Qvantig + Yervoy + chemotherapy Dose 2 Endpoints •Primary: Cmax, Tmax (nivolumab SC PK endpoints) Status •Projected data readout 2027 CT Identifier NCT06946797
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Q3 2026 Results Not for Product Promotional Use 26 atigotatug (anti-fucosyl-GM1) + nivolumab (anti-PD1) Indication 1L ES-SCLC Phase/Study Phase III - TIGOS # of Patients N = 530 Design •Atigotatug + nivolumab FDC combined with carboplatin + etoposide IV Q3W followed by atigotatug + nivolumab FDC maintenance •Atezolizumab combined with carboplatin + etoposide IV Q3W followed by atezolizumab maintenance Endpoints •Primary: OS •Key Secondary: Time to definitive deterioration (TTDD) Status •Recruiting •Projected data readout 2027 CT Identifier NCT06646276
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Q3 2026 Results Not for Product Promotional Use 27 iza-bren (izalontamab brengitecan, EGFR x HER3 ADC) Indication Advanced Solid Tumors Phase/Study Phase I/II - CA244-0001 # of Patients N = 416 Design •Group A: iza-bren D1/D8 Q3W schedule combination with osimertinib •Group B: iza-bren D1/D8 Q3W schedule combination with pembrolizumab •Group C: iza-bren combination with nivolumab •Group D & E: iza-bren combination with pumitamig (BNT327) Endpoints Primary: Safety & tolerability Key Secondary: PK, ORR, DOR Status •Recruiting •Projected data readout 2031 CT Identifier NCT06618287
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Q3 2026 Results Not for Product Promotional Use 28 iza-bren (izalontamab brengitecan, EGFR x HER3 ADC) Indication EGFR-mutated Post-TKI NSCLC 1L EGFR-mutated NSCLC Phase/Study Phase II/III – IZABRIGHT-Lung01 Phase III – IZABRIGHT-Lung02 # of Patients N = 500 N = 850 Design Phase II •Iza-bren Dose 1 D1/D8 Q3W •Iza-bren Dose 2 D1/D8 Q3W •Platinum-based chemotherapy + pemetrexed Phase III •Iza-bren at RP3D •Platinum-based chemotherapy + pemetrexed •Iza-bren + osimertinib •Osimertinib or osimertinib + platinum-based chemotherapy Endpoints Phase II Phase III Primary: PFS Primary: PFS Key Secondary: OS, ORR Key Secondary: OS, ORR Primary: PFS Key Secondary: OS Status •Recruiting •Projected data readout 2028 •Recruiting •Projected data readout 2031 CT Identifier NCT07100080 NCT07680790
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Q3 2026 Results Not for Product Promotional Use 29 iza-bren (izalontamab brengitecan, EGFR x HER3 ADC) Indication 1L TNBC Post-IO Metastatic Urothelial Cancer Phase/Study Phase II/III – IZABRIGHT-Breast01 Phase II/III – IZABRIGHT-Bladder01 # of Patients N = 600 N = 470 Design Phase II •Iza-bren Dose 1 D1/D8 Q3W •Iza-bren Dose 2 D1/D8 Q3W •Treatment of physician's choice Phase III •Iza-bren at RP3D •Treatment of physician's choice Participants ineligible for anti-PD(L1), CPS<10 Phase II •Iza-bren Dose 1 D1/D8 Q3W •Iza-bren Dose 2 D1/D8 Q3W •Cisplatin/carboplatin D1 Q3W + gemcitabine D1/D8 Q3W Phase III •Iza-bren at RP3D •Cisplatin/carboplatin D1 Q3W + gemcitabine D1/D8 Q3W Endpoints Phase II •Primary: PFS •Key Secondary: OS Phase III •Primary: PFS •Key Secondary: OS Phase II •Primary: RP3D •Key Secondary: PFS, OS, ORR Phase III •Primary: PFS, OS •Key Secondary: OR, DOR, TTR Status •Recruiting •Projected data readout 2027 (Phase 2) •Recruiting •Projected data readout 2029 CT Identifier NCT06926868 NCT07106762
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Q3 2026 Results Not for Product Promotional Use 30 navlimetostat (PRMT5 inhibitor) Indication 1L Metastatic NSCLC (with homozygous MTAP deletion) 1L Metastatic PDAC (with homozygous MTAP deletion) Phase/Study Phase II/III – MountainTAP-29 Phase II/III – MountainTAP-30 # of Patients N = 590 N = 470 Design Phase II •Navlimetostat Dose 1 + pembrolizumab + chemo •Navlimetostat Dose 2 + pembrolizumab + chemo •Placebo + pembrolizumab + chemotherapy Phase III •Navlimetostat + pembrolizumab + chemo •Placebo + pembrolizumab + chemotherapy Phase II •Navlimetostat Dose 1 + gemcitabine + nab-paclitaxel •Navlimetostat Dose 2 + gemcitabine + nab-paclitaxel •Placebo + gemcitabine + nab-paclitaxel Phase III •Navlimetostat + gemcitabine + nab-paclitaxel •Placebo + gemcitabine + nab-paclitaxel Endpoints Phase II •Primary: PFS •Key Secondary: ORR, DOR Phase III •Primary: PFS, OS •Key Secondary: ORR, DOR Phase II •Primary: PFS •Key Secondary: ORR, DOR Phase III •Primary: PFS, OS •Key Secondary: ORR, DOR Status •Recruiting •Projected data readout 2031 •Active, not recruiting •Projected data readout 2029 CT Identifier NCT07063745 NCT07076121
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Q3 2026 Results Not for Product Promotional Use 31 navlimetostat (PRMT5 inhibitor) Indication Advanced Solid Tumors (with homozygous MTAP deletion) Phase/Study Phase II – MountainTAP-5 # of Patients N = 260 Design Part I •Navlimetostat mono (Solid Tumors) Part II •Navlimetostat + pumitamig + chemotherapy (NSCLC) •Navlimetostat + daraxonrasib ± gemcitabine/nab-paclitaxel (PDAC) •Navlimetostat + temozolomide + radiotherapy (GBM) •Navlimetostat + Opdualag (Melanoma) Endpoints Part I •Primary: ORR •Key Secondary: DOR, TTR Part II •Primary: DLTs, AEs, SAEs •Key Secondary: ORR, DOR, TTR Status •Recruiting •Projected data readout 2032 CT Identifier NCT07492680
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Q3 2026 Results Not for Product Promotional Use 32 nivolumab + relatlimab HD (anti-PD1 + anti-LAG3 FDC) Indication 1L NSCLC PD-L1≥1% Phase/Study Phase III – RELATIVITY-1093 # of Patients N = 1,000 Design •Nivolumab + relatlimab FDC IV 360 mg/360 mg + chemotherapy Q3W •Pembrolizumab 200 mg + chemotherapy IV Q3W Endpoints •Primary: OS •Key Secondary: PFS, ORR Status •Recruiting •Projected data readout 2030 CT Identifier NCT06561386
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Q3 2026 Results Not for Product Promotional Use 33 pumitamig (BNT327, PD-L1 x VEGF-A) Indication 1L NSCLC 1L ES-SCLC Phase/Study Phase II/III – ROSETTA Lung-02* Phase III – ROSETTA Lung-01* # of Patients N = 1,260 N = 621 Design Non-Squamous Phase II •Pumitamig Dose 1 + carboplatin + pemetrexed •Pumitamig Dose 2 + carboplatin + pemetrexed Phase III •Pumitamig RP3D + carboplatin + pemetrexed •Pembrolizumab + carboplatin + pemetrexed Squamous Phase II •Pumitamig Dose 1 + carboplatin + paclitaxel •Pumitamig Dose 2 + carboplatin + paclitaxel Phase III •Pumitamig RP3D + carboplatin + paclitaxel •Pembrolizumab + carboplatin + paclitaxel •Atezolizumab + etoposide + carboplatin •Pumitamig + etoposide + carboplatin Endpoints Phase II: •Primary: Safety & tolerability •Key Secondary: ORR, DOR Phase III: •Primary: PFS •Key Secondary: OS, ORR, DOR •Primary: OS •Key Secondary: PFS, ORR Status •Recruiting •Projected data readout 2029 •Recruiting •Projected data readout 2028 CT Identifier NCT06712316 NCT06712355 *Trials conducted by BioNTech
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Q3 2026 Results Not for Product Promotional Use 34 pumitamig (BNT327, PD-L1 x VEGF-A) Indication Stage III NSCLC 1L NSCLC PD-L1≥50% Phase/Study Phase III – ROSETTA Lung-201 Phase III – ROSETTA Lung-202 # of Patients N = 850 N = 750 Design •Pumitamig •Durvalumab •Pumitamig •Pembrolizumab Endpoints •Primary: PFS •Key Secondary: OS, OR •Primary: PFS, OS •Key Secondary: OR Status •Recruiting •Projected data readout 2030 •Recruiting •Projected data readout 2031 CT Identifier NCT07361497 NCT07361510
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Q3 2026 Results Not for Product Promotional Use 35 pumitamig (BNT327, PD-L1 x VEGF-A) Indication 1L MSS CRC 1L Gastric Cancer 1L TNBC Phase/Study Phase II/III – ROSETTA CRC-203 Phase II/III – ROSETTA Gastric-204 Phase III – ROSETTA Breast-01* # of Patients N = 990 N = 690 N = 558 Design •Pumitamig + chemotherapy •Bevacizumab + chemotherapy •Pumitamig + chemotherapy •Nivolumab + chemotherapy •Pumitamig + treatment of physician’s choice (TPC) chemotherapy •Placebo + TPC chemotherapy Endpoints Phase II •Primary: OR •Key Secondary: PFS, DOR Phase III •Primary: PFS •Key Secondary: OS, OR, DOR Phase II •Primary: OR •Key Secondary: PFS, DOR Phase III •Primary: PFS, OS •Key Secondary: OR, DOR •Primary: PFS, OS •Key Secondary: ORR, DOR, DCR Status •Recruiting •Projected data readout 2030 •Recruiting •Projected data readout 2030 •Recruiting •Projected data readout 2029 CT Identifier NCT07221357 NCT07221149 NCT07173751 *Trial conducted by BioNTech
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Q3 2026 Results Not for Product Promotional Use 36 pumitamig (BNT327, PD-L1 x VEGF-A) Indication 1L HCC 1L RCC 2L NSCLC (post-chemoimmunotherapy) Phase/Study Phase I/II – ROSETTA HCC-206 Phase I/II – ROSETTA RCC-208 Phase II – ROSETTA Lung-107* # of Patients N = 198 N = 474 N = 60 Design •Pumitamig •Pumitamig + ipilimumab •Pumitamig •Pumitamig + ipilimumab •Pumitamig + cabozantinib •Pumitamig + casdatifan •Pumitamig + casdatifan + ipilimumab •Pumitamig + docetaxel Endpoints Phase I: •Primary: Safety & tolerability Phase II: •Primary: ORR •Key Secondary: AEs, SAEs, TRAEs Phase I: •Primary: Safety & tolerability Phase II: •Primary: ORR •Key Secondary: AEs, SAEs, TRAEs •Primary: Safety & tolerability, ORR •Key Secondary: PFS, DOR Status •Recruiting •Projected data readout 2029 •Recruiting •Projected data readout 2029 •Data presented at ESMO 2026 CT Identifier NCT07291076 NCT07293351 NCT06841055 *Trial conducted by BioNTech
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Q3 2026 Results Not for Product Promotional Use 37 RYZ101 225Ac-DOTATATE (SSTR2 binder) Indication 2L+ SSTR2+ GEP-NETs* SSTR+ HR+/HER2- Metastatic Breast Cancer Phase/Study Phase III – ACTION-1 Phase Ib/II – TRACY-1 # of Patients N = 288 N = 64 Design •RYZ101 10.2 MBq Q8W •SoC as per investigator’s discretion — everolimus 10 mg QD, sunitinib 37.5 mg QD, octreotide 60 mg Q4W, or lanreotide 120 mg Q2W Phase Ib dose escalation •RYZ101 Q6W x 6 infusions Phase II: •RYZ101 RP2D Endpoints Phase III: •Primary: PFS •Key Secondary: OS Phase Ib: •Primary: RP2D Phase II: •Primary: ORR Status •Topline readout October 2026 •Recruiting •Projected data readout 2028 CT Identifier NCT05477576 NCT06590857 *GEP-NETs expressing SSTR2 who are refractory to LU177 SA treatment
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Q3 2026 Results Not for Product Promotional Use 38 Reblozyl (erythroid maturation agent) Indication 1L+ TD MF Associated Anemia 1L NTD Low or Intermediate Risk MDS Associated Anemia Phase/Study Phase III – INDEPENDENCE Phase III – ELEMENT-MDS # of Patients N = 313 N = 402 Design •Reblozyl 1.33 mg/kg SC Q3W + JAK2i •Placebo SC Q3W + JAK2i •Reblozyl 1 mg/kg SC Q3W •Epoetin Alfa 450 IU/kg SC QW Endpoints Primary: •RBC-TI during any consecutive 12-week period starting within the first 24 weeks Key Secondary: •RBC-TI ≥ 16 weeks (RBC-TI 16) Primary: •Proportion of participants during Weeks 1-96 who convert to TD (≥ 3 units/16 weeks per IWG 2018) •Mean Hb increase ≥ 1.5 g/dL + TI for at least 16 weeks during Weeks 1-48 Status •U.S. FDA PDUFA March 11, 2027 •Data presented at EHA 2026 •Projected data readout 2028 CT Identifier NCT04717414 NCT05949684
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Q3 2026 Results Not for Product Promotional Use 39 Zenbexus (CELMoD) Indication 2L+ MM Post-Transplant Maintenance NDMM Phase/Study Phase III – EXCALIBER-RRMM Phase III – EXCALIBER-Maintenance # of Patients N = 939 N = 1,230 Design •Iberdomide 1.0, 1.3, 1.6 mg + daratumumab 1800 mg + dex 40 mg – (iberDd) •Daratumumab 1800 mg + bortezomib 1.3 mg/m2 a + dex 20 mga – (DVd) •Iberdomide 0.75, 1.0, 1.3 mg •Lenalidomide 10 mg Endpoints •Primary: MRD, PFS •Key Secondary: OS •Primary: PFS •Key Secondary: MRD, OS Status •U.S. FDA approval August 13, 2026 (MRD IA) •Topline readout (PFS IA) October 2026 •Projected data readout 2029 CT Identifier NCT04975997 NCT05827016 a BIW dosing
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Q3 2026 Results Not for Product Promotional Use 40 arlo-cel (arlocabtagene autoleucel, GPRC5D CAR T) Indication 4L+ MM1 2-4L MM2 Phase/Study Phase II – QUINTESSENTIAL Phase III – QUINTESSENTIAL-2 # of Patients N = 230 N = 440 Design •Arlo-cel •Arlo-cel •Standard regimens (DPd or Kd) as per investigator’s discretion Endpoints •Primary: ORR in prior 4L+ •Key Secondary: CRR in prior 4L+, ORR and CRR in all prior 3L+, BOR of PR •Primary: PFS, MRD-negative CR •Key Secondary: OS, ORR Status •Topline readout September 2026 •Recruiting •Projected data readout 2028 CT Identifier NCT06297226 NCT06615479 1. Quad Class Exposed - Received at least 4 classes of treatment including IMiD, PI, anti-CD38 mAb, BCMA and at least 3 prior LoT; 2. Exposed to lenalidomide
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Q3 2026 Results Not for Product Promotional Use 41 mezigdomide (CELMoD) Indication 2L+ MM 2L+ MM 2-4L MM Phase/Study Phase III – SUCCESSOR-1 Phase III – SUCCESSOR-2 Phase I/II – CA057-1040 # of Patients N = 810 N = 606 N = 62 Design •Mezigdomide 1.0 mg + bortezomib 1.3 mg/m2a + dex 20 mg – (MeziVd) •Pomalyst 4 mg + bortezomib 1.3 mg/m2a + dex 20 mg – (PVd) •Mezigdomide 1.0 mg + carfilzomib 56 mg/m2b + dex 40 mg b – (MeziKd) •Carfilzomib 56 mg/m2a + dex 20 mga or 70 mg/m2b + dex 40 mgb - (Kd) •Phase I (dose escalation) •Phase II (dose expansion) •Mezigdomide + elranatamab + dexamethasone Endpoints •Primary: PFS •Key Secondary: OS •Primary: PFS •Key Secondary: OS •Primary: Safety & tolerability, RP2D •Key Secondary: ORR, CRR Status •Recruiting •Projected data readout 2027 •U.S. FDA PDUFA May 13, 2027 •Recruiting •Projected data readout 2027 CT Identifier NCT05519085 NCT05552976 NCT06988488 a BIW dosing; b QW dosing
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Q3 2026 Results Not for Product Promotional Use 42 golcadomide (CELMoD) Indication High-Risk 1L LBCL 2L+ FL Newly Diagnosed Advanced Stage 1L FL Phase/Study Phase III – GOLSEEK-1 Phase III – GOLSEEK-4 Phase II – GOLSEEK-2 # of Patients N = 850 N = 400 N = 95 Design •Golcadomide 0.4 mg + R-CHOP •Placebo + R-CHOP •Golcadomide 0.4 mg + R •Investigator’s choice (R-lenalidomide or R-chemo) •Golcadomide 0.2 mg + R •Golcadomide 0.4 mg + R •R + chemotherapy (CHOP or bendamustine) Endpoints •Primary: PFS •Key Secondary: OS, PFS in non- HGBL, PFS in IPI 3-5, EFS, CMR, MRD •Primary: PFS •Key Secondary: ORR, OS •Primary: CMR (golcadomide + R arms only) Status •Projected data readout 2027 •Recruiting •Projected data readout 2028 •Projected data readout 2026 CT Identifier NCT06356129 NCT06911502 NCT06425302
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Q3 2026 Results Not for Product Promotional Use 43 Sotyktu (TYK-2 inhibitor) Indication Systemic Lupus Erythematosus (SLE) Sjogren’s Disease (SjD) Phase/Study Phase III – POETYK SLE-1 Phase III – POETYK SLE-2 Phase III – POETYK SjS-1 # of Patients N = 516 N = 513 N = 774 Design •Sotyktu 3 mg BID •Placebo •Sotyktu 3 mg BID •Placebo •Sotyktu 3 mg BID •Sotyktu 6 mg BID •Placebo Endpoints •Primary: Proportion of participants who meet response criteria SRI-4 at Week 52 •Primary: Proportion of participants who meet response criteria SRI-4 at Week 52 •Primary: Change from baseline in ESSDAI at Week 52 Status •Projected data readout 2026 •Projected data readout 2026 •Projected data readout 2027 CT Identifier NCT05617677 NCT05620407 NCT05946941
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Q3 2026 Results Not for Product Promotional Use 44 admilparant (LPA1 antagonist) Indication Idiopathic Pulmonary Fibrosis (IPF) Progressive Pulmonary Fibrosis (PPF) Phase/Study Phase III – ALOFT-IPF Phase III – ALOFT-PPF # of Patients N = 1,255 N = 1,057 Design •Admilparant 60 mg BID •Admilparant 120 mg BID •Placebo •Admilparant 60 mg BID •Admilparant 120 mg BID •Placebo Endpoints Cohort 1: •Primary: No. of participants that experience spontaneous syncopal events over first 4 weeks •Key Secondary: No. of participants who discontinued treatment due to any low BP-related Adverse Events Cohort 2: •Primary: Absolute change from baseline in forced vital capacity measured in mL •Key Secondary: Disease progression Cohort 1: •Primary: No. of participants that experience spontaneous syncopal events over first 4 weeks Cohort 2: •Primary: Absolute change from baseline in forced vital capacity measured in mL •Key Secondary: Disease progression Status •Topline readout October 2026 •Projected data readout 2027 CT Identifier NCT06003426 NCT06025578
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Q3 2026 Results Not for Product Promotional Use 45 obexelimab (CD19 x FcγRIIB bifunctional mAb) Indication IgG4-Related Disease Phase/Study Phase III – INDIGO # of Patients N = 194 Design •Obexelimab SC •Placebo SC Endpoints •Primary: Time to first IgG4-RD flare that requires initiation of rescue therapy in the opinion of the investigator and the Adjudication Committee (AC) from randomization to Week 52 Status •Topline readout January 2026 •Data presented at EULAR 2026 CT Identifier NCT05662241
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Q3 2026 Results Not for Product Promotional Use 46 zola-cel (CD19 NEX-T CAR T) Indication Active Systemic Lupus Erythematosus (SLE) including Lupus Nephritis (LN) Active Systemic Sclerosis (SSc) Phase/Study Phase II – Breakfree-SLE 1 Phase III – Breakfree-SSc # of Patients N = 89 N = 92 Design •Zola-cel 10M cell single infusion •Zola-cel 10M cell single infusion •SoC choice of rituximab, tocilizumab, or nintedanib Endpoints •Primary: Proportion of participants achieving drug-free Definition of Remission in SLE (DORIS) remission at Month 6 •Key Secondary: CRR, Participants with drug-free DORIS remission •Primary: Absolute change from baseline in FVC in mL at Month 12 •Key Secondary: Absolute change from baseline in mRSS at Month 12 Status •Active, not recruiting •Projected data readout 2028 •Active, not recruiting •Projected data readout 2029 CT Identifier NCT07015983 NCT07335562 1. Participants with inadequate response to glucocorticoids and at least 2 immunosuppressants
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Q3 2026 Results Not for Product Promotional Use 47 delocamten (MYK-224, myosin inhibitor) Indication Heart Failure with Preserved Ejection Fraction (HFpEF) Phase/Study Phase IIa – AURORA-HFpEF # of Patients N = 227 Design •MYK-224 •Placebo Endpoints Primary: •TEAEs and SAEs •AEs leading to treatment discontinuation Key Secondary: •Summary of plasma concentrations of MYK-224 Status •Projected data readout 2026 CT Identifier NCT06122779
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Q3 2026 Results Not for Product Promotional Use 48 milvexian (FXIa inhibitor) Indication Secondary Stroke Prevention Non-Valvular Atrial Fibrillation Phase/Study Phase III – LIBREXIA-STROKE Non-BMS Sponsored* Phase III – LIBREXIA-AF Non-BMS Sponsored* # of Patients N = 12,523 N = 20,284 Design •Milvexian 25 mg BID + background antiplatelet therapy •Placebo + background antiplatelet therapy •Milvexian 100 mg BID •Eliquis Endpoints Primary: •Time to first occurrence of ischemic stroke Key Secondary: •Time to first occurrence of any component of the composite of CVD, MI, or ischemic stroke •Time to first occurrence of ischemic stroke at 90 days Primary: •Time to first occurrence of composite endpoint of stroke & non-CNS systemic embolism Key Secondary: •Time to first occurrence of ISTH major bleeding •Time to first occurrence of the composite of ISTH major & CRNM bleeding •Time to the First Occurrence of Composite Endpoint of Stroke, Non- CNS Systemic Embolism and ISTH Major Bleeding Status •Projected data readout 2026 (event driven) •Projected data readout Q1 2027 (event driven) CT Identifier NCT05702034 NCT05757869 *Trials conducted by Johnson & Johnson
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Q3 2026 Results Not for Product Promotional Use 49 Cobenfy (M1/M4 muscarinic agonist) Indication Alzheimer’s Disease Psychosis (ADP) Phase/Study Phase III – ADEPT-1 Phase III – ADEPT-2 # of Patients N = 410 N = 500 Design •Cobenfy 20 mg/2 mg TID, 30 mg/3 mg TID, 40 mg/4 mg TID, 50 mg/5 mg TID, 66.7/6.67 mg TID* •Placebo •Cobenfy 20 mg/2 mg TID, 30 mg/3 mg TID, 40 mg/4 mg TID, 50 mg/5 mg TID, 66.7/6.67 mg TID* •Placebo Endpoints Primary: •Time from randomization to relapse during the 26-week double blind randomized withdrawal period Key Secondary: •Time from randomization to first occurrence of treatment discontinuation for any reason or relapse during the 26- week double-blind randomized withdrawal period •Change in NPI-C Core Caregiver Distress score from time of randomization to the end of the double-blind randomized withdrawal period or up to relapse, whichever occurs first Primary: •Change from baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score to end of Week 14 Key Secondary: •Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale up to Week 14 Status •Recruiting •Projected data readout 2027 •Recruiting •Projected data readout 2027 CT Identifier NCT05511363 NCT06126224 *Based on tolerability
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Q3 2026 Results Not for Product Promotional Use 50 Cobenfy (M1/M4 muscarinic agonist) Indication Alzheimer’s Disease Psychosis (ADP) Phase/Study Phase III – ADEPT-4 Phase III – ADEPT-5 # of Patients N = 406 N = 325 Design •Cobenfy 20 mg/2 mg TID, 30 mg/3 mg TID, 40 mg/4 mg TID, 50 mg/5 mg TID, 66.7/6.67 mg TID* •Placebo •Diagnosis confirmed by biomarker (blood, CSF or PET) •Cobenfy BID* for Randomized Treatment and OLE periods: 56/6mg, 112/12mg, 168/18mg, 224/24mg •Placebo •Diagnosis confirmed by biomarker (blood, CSF or PET) Endpoints •Primary: Change from baseline in Neuropsychiatric Inventory- Clinician: Hallucinations and Delusions (NPI-C: H+D) score up to Week 14 •Key Secondary: Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale up to Week 14 •Primary: Change From Baseline to end of Week 12 in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score •Key Secondary: Change From Baseline to end of Week 12 in Clinical Global Impressions-Severity (CGI-S) score Status •Recruiting •Projected data readout 2027 •Recruiting •Projected data readout 2028 CT Identifier NCT06585787 NCT06947941 * Based on tolerability
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Q3 2026 Results Not for Product Promotional Use 51 Cobenfy (M1/M4 muscarinic agonist) Indication Bipolar-I Mania Adjunctive Bipolar-I Mania Phase/Study Phase III – BALSAM-1 Phase III – BALSAM-2 Phase III - BALSAM-4 # of Patients N = 274 N = 274 N = 424 Design •KarXT BID* •Placebo •KarXT BID* •Placebo •KarXT BID* + Background Treatment (Li, VPA, or lamotrigine) •Placebo + Background Treatment (Li, VPA, or lamotrigine) Endpoints •Primary: Change from baseline in Young Mania Rating Scale (YMRS) at Week 3 •Key Secondary: Change from baseline in Clinical Global Impressions-Bipolar (CGI-BP) at Week 3 •Primary: Change from baseline in Young Mania Rating Scale (YMRS) at Week 3 •Key Secondary: Change from baseline in Clinical Global Impressions-Bipolar (CGI- BP) at Week 3 •Primary: Change from baseline in YMRS total score at Week 5 •Key Secondary: Change from baseline in Clinical Global Impression-Severity (CGI- S) score at Week 5 Status •Recruiting •Projected data readout 2027 •Recruiting •Projected data readout 2027 •Recruiting •Projected data readout 2028 CT Identifier NCT06951698 NCT06951711 NCT07140913 * Based on tolerability
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Q3 2026 Results Not for Product Promotional Use 52 Cobenfy (M1/M4 muscarinic agonist) Indication Alzheimer’s Disease Agitation (AAD) Phase/Study Phase III – ADAGIO-1 Phase III – ADAGIO-2 # of Patients N = 426 N = 426 Design •KarXT + KarX-EC •Placebo •KarXT + KarX-EC •Placebo Endpoints •Primary: Mean change from baseline on the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) at Week 14 •Key Secondary: Mean change from baseline on the Clinical Global Impressions-Severity (CGI-S) at Week 14 •Primary: Mean change from baseline on the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) at Week 14 •Key Secondary: Mean change from baseline on the Clinical Global Impressions-Severity (CGI-S) at Week 14 Status •Recruiting •Projected data readout 2029 •Recruiting •Projected data readout 2028 CT Identifier NCT07011732 NCT07011745
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Q3 2026 Results Not for Product Promotional Use 53 Cobenfy (M1/M4 muscarinic agonist) Indication Alzheimer’s Disease Cognition (ADC) Phase/Study Phase III – MINDSET 1 Phase III – MINDSET 2 # of Patients N = 586 N = 586 Design •KarXT + KarX-EC •Placebo •KarXT + KarX-EC •Placebo Endpoints Co-Primary: •Change from baseline in Alzheimer’s Disease Assessment Scale- Cognitive Subscale 11 (ADAS-Cog11) at Week 24 •Clinician’s Interview-Based Impression Plus Caregiver Input (CIBIC+) at Week 24 Key Secondary: •Change from baseline in Alzheimer’s Disease Cooperative Study- Activities of Daily Living scale (ADCS-ADL) at Week 24 Co-Primary: •Change from baseline in Alzheimer’s Disease Assessment Scale- Cognitive Subscale 11 (ADAS-Cog11) at Week 24 •Clinician’s Interview-Based Impression Plus Caregiver Input (CIBIC+) at Week 24 Key Secondary: •Change from baseline in Alzheimer’s Disease Cooperative Study-Activities of Daily Living scale (ADCS-ADL) at Week 24 Status •Recruiting •Projected data readout 2028 •Recruiting •Projected data readout 2028 CT Identifier NCT06976216 NCT06976203
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Q3 2026 Results Not for Product Promotional Use 54 Cobenfy (M1/M4 muscarinic agonist) Indication Pediatric Autism Irritability Phase/Study Phase III – CN012-0044 Phase III – CN012-0045 # of Patients N = 176 N = 176 Design •KarXT + KarX-EC •Placebo •KarXT + KarX-EC •Placebo Endpoints Primary: •Change From Baseline in the Aberrant Behavior Checklist Irritability (ABC-I) Score at Week 8 Key Secondary: •Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Week 8 Primary: •Change From Baseline in the Aberrant Behavior Checklist Irritability (ABC-I) Score at Week 8 Key Secondary: •Change From Baseline in the Clinical Global Impression- Severity (CGI-S) Score at Week 8 Status •Trial initiating •Projected data readout 2029 •Trial initiating •Projected data readout 2029 CT Identifier NCT07284745 NCT07285798
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Q3 2026 Results Not for Product Promotional Use 55 Indication Multiple Sclerosis Spasticity (MSS) Alzheimer’s Disease Agitation (AAD) Phase/Study Phase II – BALANCE-MSS-1 Phase II – BALANCE-AAD-1 # of Patients N = 200 N = 120 Design •Irafamdastat Dose 1 •Irafamdastat Dose 2 •Irafamdastat Dose 3 •Placebo •Irafamdastat Dose 1 •Irafamdastat Dose 2 •Placebo Endpoints Primary: •Change from Baseline in Numeric-transformed Modified Ashworth Scale-Most Affected Lower Limb (TNmAS-MALL) at Week 6 Key Secondary: •Change from baseline on the numeric rating scale spasticity (NRS-S) score at Week 6 •Change from baseline on the MS spasticity scale (MSSS-88) total scores at Week 6 Primary: •Change from Baseline in Cohen-Mansfield Agitation Inventory (CMAI) total score up to Week 8 Key Secondary: •Neuropsychiatric Inventory Nursing Home Version (NPI-NH) total score up to Week 8 •NPI-NH agitation/aggression domain score up to Week 8 •CMAI-IPA total score up to Week 8 •CMAI sub-scores changes in aggressive behaviors up to Week 8 Status •Recruiting •Projected data readout 2027 •Recruiting •Projected data readout 2027 CT Identifier NCT06782490 NCT06808984 irafamdastat (FAAH/MAGL inhibitor)
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Q3 2026 Results Not for Product Promotional Use 56 moponetug (anti-MTBR-tau) Indication Alzheimer’s Disease Phase/Study Phase II – TargetTau-1 # of Patients N = 310 Design •Moponetug Dose 1 •Moponetug Dose 2 •Placebo Endpoints Primary: •Mean change from baseline in brain tau deposition as measured by tau PET at Week 76 Key Secondary: •Mean change from baseline in Clinical Dementia Rating Scale–Sum of Boxes (CDR-SB) score at Week 76 •Change from baseline in integrated Alzheimer’s Disease Rating Scale (iADRS) score at Week 76 •Change from baseline in Alzheimer’s Disease Assessment Scale-Cognitive subscale (ADASCog14) score at Week 76 •Change from baseline in Mini Mental State Examination (MMSE) score at Week 76 Status •Projected data readout 2027 CT Identifier NCT06268886
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Q3 2026 Results Not for Product Promotional Use 57 Abbreviations AAD American Academy of Dermatologists Ac Actinium ACR20 American College of Rheumatology 20% Improvement Criteria ADC Antibody Drug Conjugate AE Adverse Event AF Atrial Fibrillation BID Twice a Day BIW Twice a Week BOR Best Overall Response BP Blood Pressure CAR T Chimeric Antigen Receptor T-cell therapy CD19 Cluster of Differentiation 19 CELMoD Cereblon E3 Ligase Modulatory Drug CHOP Cychophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone Cmax Maximum Concentration CMR Complete Molecular Response CNS Central Nervous System CPS Combined Positive Score CR Complete Response CRC Colorectal Cancer CRNM Clinically Relevant Non-Major CRPC Castration-Resistant Prostate Cancer CRR Complete Remission Rate CVD Cardiovascular Disease D1/D8 Day1/Day8 DCR Disease Control Rate Dd Daratumumab + Dexamethasone DOR Duration of Response DPd Daratumumab, Pomalidomide, and Dexamethasone DVd Daratumumab, Bortezomib, and Dexamethasone EFS Event Free Survival EGFR Epidermal Growth Factor Receptor EGFRmt Epidermal Growth Factor Receptor mutant EGFRwt Epidermal Growth Factor Receptor wildtype ES-SCLC Extensive-Stage Small Cell Lung Cancer ESSDAI EULAR Sjögren's Syndrome Disease Activity Index EULAR European Alliance of Associations for Rheumatology FDC Fixed Dose Combination FVC Forced Vital Capacity Hb Hemoglobin HCC Hepatocellular Carcinoma HD High Dose HER2 Human Epidermal Growth Factor Receptor 2 HER3 Human Epidermal Growth Factor Receptor 3 HGBL High-Grade B-Cell Lymphoma HR Hormone Receptor IgG4-RD Immunoglobulin G4-Related Disease IMiD Immunomodulatory Imide Drug IO Immuno-Oncology IR Inadequate Response ISTH International Society for Thrombosis and Haemostasis IU International Units IV Intravenous IWG International Working Group JAK2i Janus Kinase Inhibitor Kd Kyprolis (Carfilzomib) + dexamethasone LAG3 Lymphocyte Activation Gene 3 LBCL Large B-Cell Lymphoma LPA1 Lysophosphatidic Acid Receptor 1 LU177 SA Lutetium-177 Specific Activity mAb Monoclonal Antibody MBq Megabecquerel MDS Myelodysplastic Syndrome MF Myelofibrosis MI Myocardial Infarction MIUC Muscile Invasive Urothelial Carcinoma MM Multiple Myeloma MRD Minimal Residual Disease mRSS modified Rodnan Skin Score MTAP Methylthioadenosine Phosphorylase NDMM Newly Diagnosed Multiple Myeloma NSCLC Non-Small Cell Lung Cancer NTD Non-Transfusion Dependent ORR Overall Response Rate OR Objective Response OS Overall Survival pCR Pathological Complete Response PD1 Programmed Death-1 PDAC Pancreatic Ductal Adenocarcinoma PD-L1 Programmed Death-Ligand 1 PDUFA Prescription Drug User Fee Act PET Positron Emission Tomography PFS Progression Free Survival PK Pharmacokinetic PR Partial Response PsA Psoriatic Arthritis PVd Pomalidomide, Velcade, dexamethasone Q2W Every Two Weeks Q3W Every Three Weeks Q4W Every Four Weeks Q6W Every Six Weeks Q8W Every Eight Weeks QD Once Daily QW Once Weekly RBC Red Blood Cell R-CHOP Rituximab, Cyclophosphamide, Hydroxydaunorubicin, Oncovin, and Prednisone RFS Recurrence-free survival RP2D Recommended Phase 2 Dose RP3D Recommended Phase 3 Dose rPFS radiographic Progression-Free Survival RR Relapsed/Refractory SAE Serious Adverse Event SC Subcutaneous SoC Standard of Care SRI Systemic Lupus Responder Index SSTR2 Somatostatin Receptor 2 TD Transfusion Dependent TEAE Treatment Emergent Adverse Events TI Transfusion Independence TID Three times a day TKI Tyrosine-Kinase Inhibitor Tmax Time to Maximum Concentration TNBC Triple-Negative Breast Cancer TNF Tumor Necrosis Factor TTR Time to Response TYK-2 Tyrosine Kinase 2 Vd Velcade + Dexamethasone VEGF-A Vascular Endothelial Growth Factor A