Investor Presentaiton

Made public by

sourced by PitchSend

21 of 60

Creator

PitchSend logo
PitchSend

Category

Pending

Published

Unknown

Slides

Transcriptions

#1Q3 2023 Results October 26, 2023 Illi Bristol Myers Squibb™#2Forward Looking Statements and Non-GAAP Financial Information 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, including our ability to complete the acquisition of Mirati Therapeutics, Inc. 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 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 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. ll Bristol Myers Squibb™ | Q3 2023 Results Not for Product Promotional Use 2#3Bristol Myers Squibb Q3 2023 Results Giovanni Caforio, MD Board Chair and Chief Executive Officer#4Bristol Myers Squibb Q3 2023 Results Chris Boerner, PhD Chief Operating Officer Chief Executive Officer, effective November 1, 2023#5Q3 2023 Performance Commercial & Financial Execution Business Development Q3 Global Net Sales • 11.0B; (2%) YoY; (3%) Ex-FX* In-Line Brands & New Product Portfolio • ~$9.3B; +8% YoY; +7% Ex-FX* Earnings per Share (EPS) • GAAP $0.93, +24% YoY Non-GAAP* $2.00, +1% YoY MIRATI THERAPEUTICS Entered into acquisition agreement with planned close by 1H 2024 Strengthens & diversifies Oncology portfolio Financial Outlook Pipeline Execution • Medium-Term Financial Targets* Reaffirms 1: Low-to-mid single digit revenue CAGR² Low double-digit revenue CAGR² ex-Rev/Pom $8-10B revenue growth from in-line brands³ Adjusts: >$10B growth from new product portfolio in 2026 Operating margin to >37%4 Reblozyl: U.S. approval in 1L MDS associated anemia (COMMANDS) Opdivo: U.S. & EU approval in Stage II adj. melanoma (CM-67K); positive Ph3 in SC nivolumab (CM-67T) & peri-adj. lung (CM-77T) LPA, antagonist: Established PoC in PPF ll Bristol Myers Squibb Q3 2023 Results *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. 2020-2025 Financial Targets 2. At constant exchange rates on a risk-adjusted basis 3. Primarily 1-0 & Eliquis 4. Target through 2025 Not for Product Promotional Use LO 5#6Our Goal is to Deliver Sustainable Growth Four Key Enablers Evolve R&D for scientific leadership Strong commercial execution to realize value of our marketed portfolio Execute strategic capital allocation to further strengthen our growth profile Foster a high- performance culture and attract & retain industry-leading talent We are driven by our mission: Transforming patients' lives through science ll Bristol Myers Squibb Q3 2023 Results Not for Product Promotional Use 6#7Solid Momentum in Q3 & Accelerating Future Growth New Product Portfolio Outlook* Key In-Line Products $ in millions Eliquis. apixaban +67% ex-FX* $928 • $29 $43 $66 • Strong U.S. demand $68 • growth growth offset by gross- to-net adjustments OPDIVO (nivolumab) INJECTION FOR INTRAVENOUS USE 10 mg/mL Continued demand $92 . $553" $93 $21 $32 $1 -$5 $44 $123 $107 $69 $84 $248 $190 $166 Expect >$10B revenue from new product portfolio in 2026 Focused on product acceleration to enable future growth Planned expansion of new product portfolio with repotrectinib¹ & Krazati² Delivered key clinical milestones to enable future growth Bristol Myers Squibb™ Q3 2023 Results Q3 2022 Q3 2023 Reblozyl ■Camzyos ■Opdualag ■Sotyktu Zeposia ■Onureg Abecma ■Inrebic ■Breyanzi 1. *See "Forward-Looking Statements and Non-GAAP Financial Information" **Q3 2022 sales: Camzyos - $5M & Sotyktu - $1M U.S. PDUFA: November 27, 2023 2. Subject to satisfaction of customary closing conditions; anticipated closing by 1H 2024 Not for Product Promotional Use 7#8Strong Delivery from our R&D Engine Since R&D Day Opdivo Oncology - U.S. approval in Stage II adj. melanoma - Peri-adj. lung & 1L MIUC presented at ESMO - Met co-primary endpoints for SC nivolumab¹ Krazati² - 1L lung TPS ≥ 50% encouraging Ph2 data at ESMO Immunology LPA₁ antagonist - Breakthrough Therapy Designation granted in PPF CD19 NEXT Cell Therapy - Enrolling patients in Ph1 severe, refractory SLE trial - Achieved FDA clearance to initiate MS trial Hematology Reblozyl - U.S. approval in 1L MDS associated anemia with a broad label Other assets - Data to be presented on key assets at ASH 2023 ll Bristol Myers Squibb Q3 2023 Results 1. Subcutaneous nivolumab could provide U.S. approval in indications representing 65-75% of Opdivo business & benefit patients into the early 2030s 2. Subject to satisfaction of customary closing conditions; anticipated closing by 1H 2024 Not for Product Promotional Use 80#9Mirati Therapeutics: Strong Strategic Fit Extending in 10 OPDIVO (nivolumab) Opdualag Best-in-class KRASG12C inhibitor approved in 2L+ mutated NSCLC; confirmatory Ph3 results expected 1H 2024 • Potential KRASG12C mutated tumor opportunities: 1L NSCLC; 2L & 3L+ CRC Development Status Ph3 initiation by YE 2023 Indication TPS ≥50%: Krazati + pembrolizumab 1L NSCLC YERVOY TPS <50%: Krazati + pembrolizumab + chemo Ph2 data expected in 1H 2024 (ipilimumab) Injection for intravenous use | 480 mg/160 mg 2L CRC Krazati + cetuximab 3L+ CRC Ph3 data expected in 2024 Ph2 submission expected by YE 2023 (nivolumab and relatlimab-rmbw) Diversifying beyond 10 repotrectinib¹ (U.S. PDUFA: 11/27/23) KRAZATI® (adagrasib) 200 mg TABLETS 2 Selective PRMT5/MTA inhibitor (MRTX1719): Potential first-in-class asset Ph2 expected to initiate 1H 2024; Fast Track Designation granted Early Clinical Programs: Additional opportunities from KRAS inhibitors & enabling programs (e.g., SOS1 inhibitor) Planned close by 1H 20242 ll Bristol Myers Squibb Q3 2023 Results 1. Acquired from Turning Point Therapeutics Not for Product Promotional Use 9 2. Subject to satisfaction of customary closing conditions; anticipated closing by 1H 2024#10Continued Strong Pipeline Execution 2023 Key Milestones Early Stage: Opdivo Neo-adjuvant NSCLC Ph3 (CM-816) approval in EU iberdomide (+/- Yervoy) Initiation of pivotal post-transplant maintenance H2H vs Revlimid 2024/2025 Key Milestones Metastatic: 1L HCC Ph3 (CM-9DW) Reblozyl 1L+ MSI High CRC Ph3 (CM-8HW) 1L MF Ph3 (INDEPENDENCE) EoE Ph3 cendakimab Metastatic: Early Stage: Sotyktu PSA Ph3 X 1L mCRPC Ph3 (CM-7DX) Reblozyl 1L MDS (COMMANDS) U.S. filing Opdualag 1L NSCLC Ph21 Opdivo (+/- Yervoy) Peri-adj NSCLC Ph3 (CM-77T) Zeposia ☐ Peri-adj MIBC Ph3 CD maintenance Ph3 (YELLOWSTONE) ROS1+ NSCLC (TRIDENT-1) Mod-to-severe PsO (CM-078) repotrectinib U.S. filing EU approval Sotyktu X CD Ph2 (IM011-023) 3-5L MM Ph3 (KarMMa-3) × UC Ph2 (IM011-127) filing Abecma Initiation NDMM Ph3 LPA₁ (KarMMa-9) Antagonist Initiation IPF Ph3 PPF Ph2 (IM027-040) 2L TE LBCL EU approval 3L+ CLL Ph1/2 Opdualag Camzyos OHCM EU approval Breyanzi (TRANSCEND-CLL) 3L+FL Ph2 (TRANSCEND- FL) LIBREXIA (milvexian) Initiation Ph3 program² alnuctamab BCMA TCE Adj HCC Ph3 (CM-9DX) Stage III Unresectable NSCLC Ph3 (CM-73L) ☐ Adj NSCLC Ph3 (ANVIL, co-op group) 1L HCC Ph2 X 2L+ HCC Ph2 2L/3L+ MSS mCRC Ph3 Initiation MM Ph3 ll Bristol Myers Squibb Q3 2023 Results 1. Data readout anticipated early 2024 2. ACS, SSP, AF trials conducted by Janssen Milestones represent data readouts unless otherwise specified; subject to positive registrational trials and health authority approval Not for Product Promotional Use 10#11Numerous Levers to Drive Long-Term Growth $г Extended durability of our 10 business with subcutaneous nivolumab and Opdualag Increasingly de-risked the New Product Portfolio Number of registrational assets increasing from 6 to 12 over the next 18 months Developing medicines in rapidly growing markets with significant commercial opportunities Leading positions with differentiated platforms in Cell Therapy and Targeted Protein Degradation 洞 Strategic optionality from Business Development ll Bristol Myers Squibb Q3 2023 Results Not for Product Promotional Use 11#12Bristol Myers Squibb Q3 2023 Results David Elkins Executive Vice President and Chief Financial Officer#13Total Company Performance Driven by In-Line & New Product Portfolios Total Company Sales -$11B (2%) YoY, (3%) Ex-FX* $B Q3 Net Sales¹ YoY % Ex-FX* % $1.7 Total Company $11.0 (2%) (3%) $2.6 In-Line Products $8.3 +3% +3% New Product $0.9 +68% +67% Portfolio $9.3 $8.6 In-Line Products & $9.3 +8% +7% New Product Portfolio Recent LOES² $1.7 (35%) (35%) Q3 2022 Q3 2023 Recent LOES In-Line & New Products ll Bristol Myers Squibb™ | Q3 2023 Results 1. Amounts may not add due to rounding *See "Forward-Looking Statements and Non-GAAP Financial Information" Not for Product Promotional Use 13 2. Recent LOE Brands = Revlimid & Abraxane#14New Product Portfolio Performance Building strong momentum for future growth $ in millions $730 $1,385 $2,513 YTD 2021 YTD 2022 YTD 2023 ll Bristol Myers Squibb Q3 2023 Results $ in millions *See "Forward-Looking Statements and Non-GAAP Financial Information" **Q3 2022 sales: Camzyos - $5M & Sotyktu - $1M +67% growth vs PY EX-FX* $928 -$29 $43 $66 $68 $92 ** $553** $93 $21 $32 $1 $5 $44 $123 $107 $166 $69 $84 $248 $190 Q3 2022 Reblozyl ■Camzyos ■Opdualag ■Sotyktu ■Onureg Zeposia Abecma ■Inrebic Q3 2023 ■Breyanzi Not for Product Promotional Use 14#15Q3 2023 Oncology Product Summary Q3 Global Net Sales $M YoY % Ex-FX* % OPDIVO (nivolumab) $2,275 +11% +11% INJECTION FOR INTRAVENOUS USE 10 mg/ml YERVOY. (ipilimumab) ERVOY Injection for intravenous infusion $579 +11% +10% Opdualag. $166 +98% +98% (nivolumab and relatlimab-rmbw) Injection for intravenous use | 480 mg/160 mg Abraxane $260 +47% +51% ll Bristol Myers Squibb Q3 2023 Results 1. Source: BMS Internal Analysis Opdivo: U.S. YoY volume growth in 1L lung, upper Gl & adj. bladder cancer • Ex-U.S. YoY growth of +15% ex-FX* primarily from demand in 1L lung & upper GI & expanded access Opdualag: U.S. growth driven by strong demand; -25% market share1 in 1L melanoma • A new SOC in 1L melanoma *See "Forward-Looking Statements and Non-GAAP Financial Information" Not for Product Promotional Use 15#16Q3 2023 Cardiovascular Product Summary Q3 Global Net Sales SM YoY % Ex-FX*% Eliquis. $2,705 +2% apixaban $M YoY % Ex-FX* % CAMZYOS™ (mavacamten) capsules $68 ** ** Best-in-class & leading OAC within category Eliquis: . . U.S. growth driven by strong underlying demand offset by gross-to-net adjustments Ex-U.S. impacted by generic entry in UK & Canada, and pricing measures First-in-class myosin inhibitor U.S. increase in total treated & commercial dispensed patients Expansion in international markets based on reimbursement timing Patients in hub Patients on commercial drug As of June 30, 20231 -3800 -2500 As of Sept 30, 20231 -4900 -3500 ll Bristol Myers Squibb Q3 2023 Results 1. Source: BMS Internal Analysis *See "Forward-Looking Statements and Non-GAAP Financial Information" **In excess of +100% Not for Product Promotional Use 16#17Q3 2023 Hematology Product Summary Q3 Global Net Sales1 $M YoY % Ex-FX* % Revlimid $1,429 (41%) (41%) (lenalidomide) capsules Pomalyst $872 (pomalidomide) caus (2%) (2%) SPRYCEL $517 (8%) (8%) dasatinib Reblozyl (luspatercept-aamt) for injection 25mg .75mg $248 +31% +29% Abecma [idecabtagene vicleucel) Breyanzi (lisocabtagene maraluce... $93 (13%) (14%) FOR INFUSION $92 ** ** SUSPENSION ONUREG $43 +34% +31% (azacitidine) tablets INREBIC $29 +38% +33% (fedratinib) capsules 100mg Revlimid: FY 2023 revenue projection -$6.0B Reblozyl: • U.S. FDA approval in August 2023 in 1L MDS-associated anemia with a broad label (COMMANDS) U.S. strong YoY growth of +28% driven by demand from increased 1L use & 2L switches from ESAs as well as DoT Abecma: • Q3 impacted by manufacturing maintenance in June & increased availability of additional BCMA targeting agents Breyanzi: • Continued strong demand in 2L/3L+ LBCL Q3 impacted by timing of infusions ll Bristol Myers Squibb Q3 2023 Results 1. Empliciti grouped in Mature & Other Brands *See "Forward-Looking Statements and Non-GAAP Financial Information" **In excess of +100% Not for Product Promotional Use 17#18Q3 2023 Immunology Product Summary Q3 Global Net Sales $M YoY % Ex-FX*% ORENCIA $925 +5% +5% (abatacept) ZEPOSIA (ozanimod) capsulos $123 +78% +75% Zeposia: • . . SOTYKTU.O (deucravacitinib) 6 mg tablets $M YoY % Ex-FX*% $66 ** ** First-in-class selective allosteric TYK2 inhibitor U.S. continued volume growth; ~$30M clinical purchase in quarter Progress converting patients on CVS indication-based plans Driving demand to enable broader access in 2024 & 2025 As of June 30, 2023¹ >23K TRX Equivalent 35-40% As of Sept 30, 20231 >38K TRX Equivalent Growth from demand in MS & expanding contribution from UC • Continued focus on improving formulary access Expansion in international markets based on reimbursement timing ll Bristol Myers Squibb Q3 2023 Results 1. Source: BMS Internal Analysis; 2. Cumulative TRX equivalent since launch; 3. Market share of written oral prescriptions in NBRx sourced from BrandImpact Cumulative Volume² Market Share³ Source of Business4 . • • Systemic-naïve Biologic-experienced Otezla-experienced >40% >30% >25% 4. Q3 Source of Business proportionally distributes 15% unknown/unidentified *See "Forward-Looking Statements and Non-GAAP Financial Information"; **In excess of +100% -40% >40% >30% >25% Not for Product Promotional Use 18#19Q3 2023 Financial Performance US GAAP Non-GAAP* $ in billions, except EPS Total Revenues, net Gross Margin % Q3 2023 Q3 2022 Q3 2023 Q3 2022 11.0 11.2 11.0 11.2 77.1% 79.0% 77.3% 79.8% Operating Expenses¹ 4.2 4.3 4.1 4.1 Acquired IPR&D 0.1 0.1 Amortization of Acquired Intangibles 2.3 2.4 Effective Tax Rate 9.5% 27.2% 11.6% 16.9% Diluted EPS 0.93 0.75 2.00 1.99 Diluted Shares Outstanding (# in millions) 2,064 2,148 2,064 2,148 Diluted EPS Impact from Acquired IPR&D² ll Bristol Myers Squibb Q3 2023 Results (0.03) 0.02 (0.03) 1. Operating Expenses = MS&A and R&D 2. Comprises the net impact from Acquired IPRD & Licensing income *See "Forward-Looking Statements and Non-GAAP Financial Information" 0.02 Not for Product Promotional Use 19#20Balanced Approach to Capital Allocation Cash flow from Operations $B $3.7 $3.3 $3.0 $1.9 $4.8 Business Development Q3 2022 Q4 Q1 Q2 Q3 2022 2023 2023 2023 $B Q3 2023 Total Cash* -$8.0B ~$37.6B • Prioritize opportunities to further diversify portfolio & strengthen long-term outlook - Entered into agreement to acquire Mirati Therapeutics; planned close by 1H 2024 Balance Sheet Strength Maintain strong investment-grade credit rating Returning Cash to Shareholders Total Debt Strong operating cash flow generation ll Bristol Myers Squibb Q3 2023 Results *Cash includes cash, cash equivalents and marketable debt securities **Subject to Board approval Note: YTD operating cash may not add due to rounding • Continued annual dividend growth** Opportunistic share repurchase - Executed $4B ASR Agreements in Q3'23 - Approx. $2B remaining share authorization Not for Product Promotional Use 20#21Revised 2023 Guidance US GAAP* Total Revenues Reported Rates Total Revenues Ex-FX Revlimid Gross Margin % Non-GAAP* October (Revised) July (Prior) October (Revised) July (Prior) Low-single digit decline No Change Low-single digit decline No Change Low-single digit decline No Change Low-single digit decline No Change -$5.5 billion -$6.0 billion -$5.5 billion -$6.0 billion ~76% No Change -76% No Change Operating Expenses1 Low-single digit decline No Change Low-single digit decline No Change Tax Rate Diluted EPS ll Bristol Myers Squibb Q3 2023 Results -16% $3.72 - $4.02 ~11% $3.68 $3.83 ~17.5% $7.35 - $7.65 1. Operating Expenses = MS&A and R&D, excluding Acquired IPR&D and Amortization of acquired intangibles *See "Forward-Looking Statements and Non-GAAP Financial Information" ~15.5% $7.50 - $7.65 Not for Product Promotional Use 21#22Medium-Term Guidance* July 2023 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-$13B from New Product Portfolio in 2025 • • • October 2023 Reaffirms low-to-mid single-digit revenue CAGR¹ from 2020-2025 Reaffirms low double-digit revenue CAGR¹ ex- Rev/Pom from 2020-2025 Reaffirms $8B-$10B growth from in-line brands² from 2020-2025 Adjusts to >$10B revenue from new product portfolio in 2026 . 40%+ operating margin through 2025 • Adjusts operating margin target to >37% through 2025 ll Bristol Myers Squibb Q3 2023 Results *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" Not for Product Promotional Use 22 1. At constant exchange rates on a risk-adjusted basis 2. Primarily I-O & Eliquis#23Illi Bristol Myers Squibb™ Q3 2023 Results Q&A Giovanni Caforio, MD Board Chair, Chief Executive Officer Chris Boerner, PhD Executive VP, Chief Operating Officer, CEO effective November 1, 2023 David Elkins Executive VP, Chief Financial Officer Samit Hirawat, MD Executive VP, Chief Medical Officer, Global Drug Development Adam Lenkowsky Executive VP, Chief Commercialization Officer#24Bristol Myers Squibb Company Reconciliation of Certain GAAP Line Items to Certain Non-GAAP Line Items (Unaudited, dollars in millions) Year-Ended December 31 2020 2021 2022 Total Revenues Gross Profit Specified items (a) $42,518 $46,385 $46,159 $30,745 $36,445 $36,022 $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 $7,382 $7,687 $7,735 specified items Research and Development $10,048 $10,195 $9,509 Specified items (a) ($903) ($843) ($308) Research and Development excluding specified $9,145 $9,352 $9,201 items Operating margin 31% 40% Specified items (a) 10% 3% Operating margin excluding specified items (b) 41% 43% 41% 1% 42% ll Bristol Myers Squibb Q3 2023 Results (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. Not for Product Promotional Use 24 (b): Operating margin on Specified Items represents the difference between the GAAP and Non-GAAP operating margin#252023 Key News Flow Asset Timing Opdivo EU approval in Neo-Adj. Lung EFS EU Approval June 2023 (CM-816) Opdivo Study Discontinued¹ 1L mCRPC Ph3 (CM -7DX) Opdualag Stage IV 1L NSCLC Ph2 (CA227-104) repotrectinib ROS1+ NSCLC (TRIDENT-1) filing | Abecma 3-5L MM (KarMMa-3) filing Breyanzi EU approval in 2L LBCL (Transplant Eligible) Breyanzi 3L+ CLL Ph1/2 (TRANSCEND-CLL) Breyanzi 2L & 3L+FL Ph2 (TRANSCEND-FL) ll Bristol Myers Squibb Q3 2023 Results 1H 2024 Priority Review: U.S. PDUFA November 27, 2023 U.S. PDUFA December 16, 2023; filed in EU & Japan EU approval May 2023 Met primary endpoint in January 2023 Presented at ASCO 2023 Positive topline results in April 2023 Presented at ICML 2023 ¹Did not meet primary endpoints of rPFS at FA nor OS at IA Reblozyl Asset EU approval in NTD Beta-Thalassemia Associated Anemia Reblozyl 1L TD MDS Associated Anemia (COMMANDS) filing Sotyktu EU approval in mod-to-severe PsO POETYK PSO-1 & PSO-2 Sotyktu Crohn's Disease Ph2 (LATTICE-CD) Sotyktu Ulcerative Colitis (higher dose) Ph2 (IMO11-127) LPA₁ Antagonist Progressive Pulmonary Fibrosis (PPF) Ph2 (IM027-040) Camzyos EU approval in symptomatic obstructive HCM (EXPLORER-HCM) Camzyos U.S. & EU approval in obstructive HCM SRT eligible (VALOR) Milestones represent data readouts or approvals unless otherwise specified; subject to positive registrational trials and health authority approval Timing EU Approval March 2023 Presented at ASCO & EHA 2023 U.S. approval August 2023 & filed in EU & Japan EU Approval March 2023 PoC not achieved PoC not achieved Achieved PoC EU Approval June 2023 U.S. & EU approval June 2023 Not for Product Promotional Use 25#26Q3 2023 Opdivo Sales Mix 24% U.S. Sales Mix 11% 20% ll Bristol Myers Squibb Q3 2023 Results Ex-U.S. Sales Mix 24% 21% 29% 7% 21% 25% ■ NSCLC ■ RCC ■ Melanoma ■ Upper GI/Bladder ■ All others Note: percentages are approximate 18% OPDIVO™ (nivolumab) INJECTION FOR INTRAVENOUS USE 10 mg/mL Not for Product Promotional Use 26#27Q3 2023 Eliquis NBRX/TRx Share 24% 10% NBRx Share - US 21% 25% 9% 15% TRX Share - US Eliquis. apixaban 23% 13% 67% 70% 60% 64% Q3 2022 Q3 2023 ll Bristol Myers Squibb Q3 2023 Results Q3 2022 Q3 2023 Eliquis Warfarin Other NOACs Rx Source: IQVIA Not for Product Promotional Use 27#28Our ESG updates and looking ahead ESG Materiality Assessment Results Completed a global, double ESG materiality assessment¹ and identified the 8 ESG factors that were rated as most "material" by stakeholders ✓ Results showed strong alignment of internal and external stakeholders' priorities TOP 8 Material ESG Factors 1. Pricing & Patient Access 2. Product Innovation 3. Patient Safety and Product Quality 4. Ethics & Conduct 5. Long-Term Value Creation 6. Culture and Inclusion & Diversity 7. Climate Change & Emissions 8. Public Health & Public Policy Breakdown: Top ESG Issues by Theme Business Model & Innovation, 26% 2022 ESG Report ✓ On August 23, 2023, published BMS' 2022 ESG Report, 2 providing increased transparency and disclosures 2022 Environmental, Social and Governance Report Social Capital, 36% Bristol Myers Squibb Leadership & Governance, 16% Human Capital, 11% Environment, 11% A Table of Contents 3 & Accesso Health Equity Innovation Healthcare 27 Our People 35 Ethics, Integrity, Inclusion & Diversity 46 Looking Ahead 84 Environmental Responsibilty 56 Appendix 86 Quality & Governance 70 Evolved ESG Strategy based on double materiality assessment will be shared in 2024 Looking Ahead Task Force on Climate-Related Financial Disclosures (TCFD) report will be published later this year 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 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 ll, Bristol Myers Squibb™ | Q3 2023 Results 1 BMS ESG Materiality Assessment 2 BMS 2022 ESG Report Not for Product Promotional Use 28#29Clinical Development Portfolio - Phase I and II ✦ AHR Antagonist*^ + Anti-CCR8^ + Anti-ILT4^ + AR LDD + DGK Inhibitor ✦ Helios CELMOD ✦ JNK Inhibitor ✦ MAGE A4/8 TCER* + NME 1 ◆ SHP2 Inhibitor^ Phase I Solid Tumors Solid Tumors Solid Tumors 1L, 2L Metastatic Castration-Resistant Prostate Cancer Solid Tumors Solid Tumors Solid Tumors Prostate Cancer Solid Tumors Solid Tumors Solid Tumors Lung Cancer + TGFB Inhibitor^ Solid Tumors ◆ TIGIT Bispecific ✦ alnuctamab + Anti-SIRPa + BCL6 LDD + BCMA NKE ◆ BET Inhibitor (BMS-986378)^ + CD33 NKE ✦CK1a Degrader golcadomide^ + GPRC5D CAR T ✦ FXla Inhibitor + Anti-CD40 + CD19 NEX T + IL2-CD25 + NME 2 ✦ PKCO Inhibitor ✦ Anti-MTBR-Tau + BTK Inhibitor ✦ elF2b Activator ✦ FAAH/MGLL Dual Inhibitor Gastric Cancer RR Multiple Myeloma Hematologic Malignancies Lymphoma RR Multiple Myeloma RR Non-Hodgkin's Lymphoma Acute Myeloid Leukemia Hematologic Malignancies 1L Diffuse Large B-cell Lymphoma RR Multiple Myeloma Thrombotic Disorders Autoimmune Disease Severe Refractory Systemic Lupus Erythematosus Autoimmune Disease Autoimmune Disease Autoimmune Disease Alzheimer's Disease Neuroscience Neuroscience Neuroscience ✦ Anti-CTLA-4 NF Probody® Therapeutic ✦ Anti-Fucosyl GM1^ ✦ Anti-IL-8^ ✦ Anti-NKG2A^ BET Inhibitor (BMS-986378)^ ✦ farletuzumab ecteribulin nivolumab+relatlimab ✦ repotrectinib ✦ BET Inhibitor (BMS-986158) BREYANZI golcadomide ONUREG REBLOZYL CAMZYOS + danicamtiv + MYK-224 ✦ afimetoran SOTYKTU + TYK2 Inhibitor (BMS-986322) Phase II Solid Tumors Lung Cancer Data as of October 26th, 2023 Colorectal Cancer RR Small Cell Lung Cancer Solid Tumors Non-Small Cell Lung Cancer Solid Tumors Ovarian Cancer Non-Small Cell Lung Cancer Stage IV 1L Non-Small Cell Lung Cancer 1L Hepatocellular Carcinoma NTRK Pan-Tumor 1L Myelofibrosis 3L+ Chronic Lymphocytic Leukemia (CLL) RR Follicular Lymphoma (FL) RR Marginal Zone Lymphoma (MZL) RR Mantle Cell Lymphoma (MCL) RR Non-Hodgkin's Lymphoma Myelodysplastic Syndrome A-Thalassemia Heart Failure with preserved Ejection Fraction (HFPEF) Dilated Cardiomyopathy Obstructive Hypertrophic Cardiomyopathy Systemic Lupus Erythematosus Alopecia Areata Discoid Lupus Erythematosus Moderate-to-Severe Psoriasis Ill Bristol Myers Squibb Q3 Oncology * Partner-run study Hematology CV Neuroscience Immunology + NME leading indication ^ Trials exploring various combinations Not for Product Promotional Use 29#30Clinical Development Portfolio - Phase III OPDIVO OPDIVO+YERVOY OPDUALAG ✦ SC nivolumab + relatlimab + rHuPH20 ✦ SC nivolumab + rHuPH20 (multi-indications) + ABECMA iberdomide mezigdomide REBLOZYL CAMZYOS + milvexian ✦ cendakimab LPA1 Antagonist ✦ obexelimab * # SOTYKTU ZEPOSIA ll, Bristol Myers Squibb Q3 2023 Results Phase III Adjuvant Hepatocellular Carcinoma Peri-adjuvant Muscle-Invasive Urothelial Carcinoma Peri-adjuvant Non-Small Cell Lung Cancer Stage IB-IIIA Adjuvant NSCLC* 1L Hepatocellular Carcinoma 1L Muscle Invasive Urothelial Carcinoma 1L+ Microsatellite Instability High Colorectal Cancer Stage 3 Unresectable Non-Small Cell Lung Cancer Adjuvant Melanoma 2L/3L+ Metastatic Colorectal Cancer 1L Melanoma 2L Renal Cell Carcinoma Newly Diagnosed Multiple Myeloma with Suboptimal Response post-ASCT +2L+ Multiple Myeloma Post-Autologous Stem Cell Therapy Maintenance Newly Diagnosed Multiple Myeloma +2L+ Multiple Myeloma Vd 2L+ Multiple Myeloma Kd 1L TD Myelofibrosis Associated Anemia 1L NTD Myelodysplastic Syndrome Associated Anemia Non-Obstructive Hypertrophic Cardiomyopathy Secondary Stroke Prevention* Acute Coronary Syndrome* Atrial Fibrillation* Eosinophilic Esophagitis Eosinophilic Gastroenteritis # Idiopathic Pulmonary Fibrosis (IPF) Progressive Pulmonary Fibrosis (PPF) IgG4-Related Disease Psoriatic Arthritis Systemic Lupus Erythematosus Sjögren's Syndrome Crohn's Disease repotrectinib ABECMA REBLOZYL * Oncology Data as of October 26th, 2023 Registration US, EU, JP ROS1 NSCLC (US, JP) 3-5L Multiple Myeloma (US, EU, JP) 1L TD Myelodysplastic Syndrome Associated Anemia (EU, JP) Hematology CV Neuroscience Immunology Partner-run study ✦ NME leading indication # Certain Asian territories Development Partnerships: ABECMA: 2seventy bio; AHR: Ikena Oncology; Anti-MTBR-Tau: Prothena; CAMZYOS in China, Singapore, Thailand, Macau, HK, Taiwan: LianBio; farletuzumab ecteribulin: Eisai; rHuPH20: Halozyme; MAGEA4/8 TCER: Immatics; milvexian: Janssen Pharmaceuticals, Inc.; OPDIVO, YERVOY, OPDUALAG in Japan: Ono; PKCO Inhibitor: Exscientia; REBLOZYL: Merck; SHP2 Inhibitor: BridgeBio Pharma; TIGIT Bispecific: Agenus; obexelimab: Zenas BioPharma in Japan, South Korea, Taiwan, HK, Singapore, and Australia Not for Product Promotional Use 30#31Q3 2023 Late-Stage Drug Development Clinical Trials Update Oncology Opdivo Hematology iberdomide Cell Therapy Immunology Cardiovascular Breyanzi cendakimab milvexian Opdualag mezigdomide Abecma LPA1 antagonist Camzyos repotrectinib Reblozyl ll Bristol Myers Squibb Q3 2023 Results Onureg alnuctamab Sotyktu Zeposia obexelimab Not for Product Promotional Use 31#32Opdivo (anti-PD1) Lung Cancer Trials Indication Phase/Study # of Patients Design Endpoints Status CT Identifier Oncology Hematology Cell Therapy Immunology Cardiovascular Peri-Adjuvant NSCLC Stage IB-IIIA Adjuvant NSCLC Stage III Unresectable NSCLC Phase III CheckMate -77T N = 452 Neoadjuvant Opdivo 360mg + PDCT Q3W for 4 cycles followed by adjuvant Opdivo 480mg Q4W for 1 year Neoadjuvant placebo + PDCT followed by placebo Primary: EFS • Key secondary: OS Positive topline results in September 2023 Data presented at ESMO 2023 as a Late Breaker in the Presidential Symposium NCT04025879 • Phase III ANVIL Non-BMS Sponsored* Opdivo Q4W N = 903 Observation (patients followed serially with imaging for 1 year) • Primary: DFS, OS Phase III CheckMate -73L N = 888 Opdivo + CCRT followed by Opdivo + Yervoy Opdivo + CCRT followed by Opdivo CCRT followed by durvalumab • Primary: PFS • Key secondary: OS • Projected data readout 2025 • Projected data readout 2024 NCT02595944 NCT04026412 ll Bristol Myers Squibb Q3 2023 Results *Trial conducted by NCI/ECOG Not for Product Promotional Use 32#33Opdivo (anti-PD1) Early-Stage Trials Indication Peri-Adjuvant MIUC - Phase III CA 017-078 Phase/Study # of Patients N = 861 • Opdivo 360 mg Q3W for four cycles + chemotherapy Design Chemotherapy Primary: PCR, EFS Oncology Hematology Cell Therapy Immunology Cardiovascular Adjuvant HCC Phase III - CheckMate -9DX N = 545 Opdivo 480 mg Q4W Placebo • Primary: RFS Endpoints . Key secondary: OS Key secondary: OS Projected data readout 2025 • Projected data readout 2025 Status CT Identifier ll Bristol Myers Squibb Q3 2023 Results NCT03661320 NCT03383458 Not for Product Promotional Use 33#34Opdivo (anti-PD1) Metastatic Trials Indication 1L HCC Phase III CheckMate -9DW - N = 732 Phase/Study # of Patients Opdivo + Yervoy Design sorafenib/lenvatinib Endpoints • Primary: OS Key secondary: ORR Status CT Identifier Projected data readout 2025 ll Bristol Myers Squibb Q3 2023 Results NCT04039607 Oncology Hematology Cell Therapy Immunology Cardiovascular • Opdivo (Arm A) 1L+ MSI High CRC Phase III CheckMate -8HW Opdivo + Yervoy (Arm B) Chemotherapy (Arm C) Primary: • PFS Arm B vs. A, all lines • PFS Arm B vs. C, first line Key secondary: ORR, OS N = 831 • Projected data readout 2025 NCT04008030 Not for Product Promotional Use 34#35Oncology Hematology Cell Therapy Immunology Cardiovascular Opdivo (anti-PD1) Metastatic Trials Indication Phase/Study # of Patients Design • 1L MIUC Phase III CheckMate -901 - N = 1,290 PD-L1+ & cis-ineligible: Opdivo 1 mg/kg + Yervoy 3 mg/kg Q3W up to 4 cycles followed by Opdivo 480 mg Q4W vs SOC chemotherapy Cis-eligible: Opdivo 360 mg in combination with chemotherapy Q3W vs SOC chemotherapy Primary: PFS, OS in cis-eligible patients Endpoints OS in PD-L1+ (>=1%) & cis-ineligible 2L RCC SC Phase III CheckMate -67T - • Opdivo +rHuPH20 SC Opdivo IV N = 454 Primary: Cavgd28 (Opdivo serum concentration) ⚫ Cminss Status CT Identifier Positive topline results in cis-eligible in July 2023 Data presented at ESMO 2023 as a Late Breaker in the Presidential Symposium • Cis-eligible data published in NEJM October 2023 • Projected data readout 2024 in cis-ineligible Did not meet primary OS endpoint in PD-L1+ NCT03036098 ll Bristol Myers Squibb™ | Q3 2023 Results • Key secondary: ORR • Positive topline results in October 2023 NCT04810078 Not for Product Promotional Use 35#36Hematology Cell Therapy Immunology Cardiovascular Oncology Opdualag (anti-LAG3 + anti-PD1 FDC) Indication Phase/Study # of Patients Adjuvant Melanoma Phase III - RELATIVITY-098 N = 1050 Relatlimab + nivolumab FDC 160 Design mg/480 mg Q4W Nivolumab 480mg Q4W Primary: RFS Key secondary: OS Endpoints Status CT Identifier 1L Melanoma SC Phase III - RELATIVITY-127 N = 814 Relatlimab + nivolumab + rHuPH20 FDC SC • Relatlimab + nivolumab FDC IV Primary: • Cavgd28 of nivolumab; Cminss of nivolumab Cavgd28 of relatlimab; Cminss of relatlimab Key secondary: ORR 2L/3L+ MSS MCRC Phase III RELATIVITY-123 N = 700 Relatlimab nivolumab FDC Investigator's Choice: regorafenib or TAS-102 (trifluridine/tipiracil) Primary: • OS in PD-L1 CPS≥1 • OS in all-comers Key secondary: ORR Projected data readout 2025 Projected data readout 2026 • Recruiting • Projected data readout 2025 NCT05002569 ll Bristol Myers Squibb Q3 2023 Results NCT05625399 NCT05328908 Not for Product Promotional Use 36#37Hematology Cell Therapy Immunology Cardiovascular Oncology Opdualag (anti-LAG3 + anti-PD1 FDC) Indication Phase/Study # of Patients 1L HCC Phase I/II RELATIVITY-106 N = 162 1L Stage IV NSCLC Phase II-CA224-104 N = 420 Design Nivolumab + relatlimab + bevacizumab • Nivolumab + placebo + bevacizumab Endpoints Primary: DLTS, ORR Part I: Nivolumab + relatlimab Dose 1+ PDCT • Nivolumab + relatlimab Dose 2 + PDCT Part II: Nivolumab + relatlimab Dose 2 + PDCT • Nivolumab + PDCT Primary: • Part I: TRAEs leading to discontinuation within 12 weeks after first dose Part II: ORR Projected data readout 2024 • Recruiting Status • Projected data readout 2024 CT Identifier NCT05337137 ll Bristol Myers Squibb™ | Q3 2023 Results NCT04623775 Not for Product Promotional Use 37#38Oncology Hematology Cell Therapy Immunology Cardiovascular repotrectinib (ROS1/NTRK) Indication ROS1 NSCLC & NTRK+ Solid Tumors Phase/Study Phase I/II - TRIDENT-1 N = 500 # of Patients Design Phase I: Dose escalation; food-effect, dose escalation with food; & Midazolam DDI Phase II: Expansion cohorts • ROS1 TKI-naïve ROS1+ NSCLC 160 mg QD for the first 14 days, then 160 mg BIDa • 1 Prior ROS1 TKI and 1 Platinum based chemo ROS1+ NSCLC Endpoints Status CT Identifier • 2 Prior ROS1 TKIS ROS1+ NSCLC (No Chemo or I-O) • 1 Prior ROS1 TKI ROS1+ NSCLC (No Chemo or I-O) ⚫ TRK TKI-naïve NTRK+ solid tumors TRK TKI-pretreated NTRK+ solid tumors Primary: ⚫ Phase I: DLTS, RP2D Phase II: ORR Key Secondary ⚫ Phase II: DOR, IC-ORR Recruiting U.S. FDA Priority Review in ROS1+ NSCLC: PDUFA November 27, 2023 ROS1 data presented at IASLC WCLC 2023 NCT03093116 ll Bristol Myers Squibb Q3 2023 Results aBased on tolerability Not for Product Promotional Use 38#39mezigdomide (CELMOD) Indication Phase/Study # of Patients 2L+ MM Phase III SUCCESSOR-1 1 N = 810 Oncology Hematology Cell Therapy Immunology Cardiovascular - Mezigdomide 0.3, 0.6, 1.0 mg + bortezomib 1.3 mg/m2ª + dex 20 mg (MeziVd) • Pomalyst 4 mg + bortezomib 1.3 mg/m2a + dex 20 mg - (PVD) • Design Endpoints Status CT Identifier Primary: PFS Key secondary: OS • Recruiting Projected data readout 2026 NCT05519085 ll Bristol Myers Squibb Q3 2023 Results a BIW dosing; b QW dosing 2L+ MM Phase III - SUCCESSOR-2 N = 575 Mezigdomide 0.3, 0.6, 1.0 mg + carfilzomib 56 mg/m2b + dex 40 mg b - (Mezikd) Carfilzomib 56 mg/m2a + dex 20 mga - (Kd) Primary: PFS Key secondary: OS Recruiting Projected data readout 2026 NCT05552976 Not for Product Promotional Use 39#40iberdomide (CELMOD) Indication Phase/Study # of Patients 2L+ MM Phase III EXCALIBER - Oncology Hematology Cell Therapy Immunology Cardiovascular Post-Transplant Maintenance NDMM Phase III EXCALIBER-Maintenance Design Endpoints Status CT Identifier • N = 864 Iberdomide 1.0, 1.3,1.6 mg + daratumumab 1800 mg + dex 40 mg (iberDd) Daratumumab 1800 mg + bortezomib 1.3 mg/m2a + dex 20 mga - (DVD) Primary: PFS Key secondary: OS Recruiting Projected data readout 2026 NCT04975997 N = 1,216 Iberdomide Dose 0.75, 1.0, 1.3 mg Lenalidomide 10 mg Primary: PFS Key Secondary: MRD, OS Recruiting Projected data readout 2029 NCT05827016 ll Bristol Myers Squibb Q3 2023 Results aBIW dosing Not for Product Promotional Use 40#41Oncology Hematology Cell Therapy Immunology Cardiovascular Reblozyl (Erythroid Maturation Agent) Indication Phase/Study # of Patients 1L Myelodysplastic Syndrome (MDS) Associated Anemia Phase III COMMANDS N = 362 Reblozyl 1.0 mg/kg SC Q3W . Design Epoetin Alfa 450 IU/kg SC QW Primary: RBC-TI for 12 weeks with a mean hemoglobin increase > 1.5 g/dL through week 24 • Endpoints U.S. FDA approval August 2023 • Status Application under review in EU & Japan Data presented at ASCO & EHA 2023 • CT Identifier ll Bristol Myers Squibb™ | Q3 2023 Results NCT03682536 1L TD Myelofibrosis (MF) Associated Anemia Phase III INDEPENDENCE N = 309 Reblozyl 1.33 mg/kg SC Q3W + JAK2i Placebo SC Q3W + JAK2i Primary: RBC-TI during any consecutive 12-week period starting within the first 24 weeks Key secondary: RBC-TI ≥ 16 weeks (RBC-TI 16) Recruiting Expected data readout 2025 NCT04717414 Not for Product Promotional Use 41#42Oncology Hematology Cell Therapy Immunology Cardiovascular Reblozyl (Erythroid Maturation Agent) Indication Phase/Study # of Patients Design Endpoints Status CT Identifier TD & NTD Alpha-Thalassemia (Ex-US study) Phase II CA056-015 N = 177 Reblozyl 1.0 mg/kg SC Q3W • Placebo SC Q3W + Best Supportive Care Primary: ⚫ TD: ≥50% reduction in TF burden over any rolling 12 weeks between W13-W48 NTD: ≥1 g/dL Hb mean increase from baseline in W13- W24 Key secondary: • TD: No. of participants with ≥ 33% reduction from baseline in RBC transfusion burden • NTD: Change from baseline to W24 in hemoglobin in the absence of transfusion Recruiting Expected data readout 2025 NCT05664737 1L NTD Low-or Intermediate Risk Myelodysplastic Syndrome (MDS) Associated Anemia Phase III - ELEMENT-MDS N = 360 • Reblozyl 1.0 mg/kg SC Q3W Epoetin Alfa 450 IU/kg SC QW Primary: Proportion of participants during Wk 1-96 who convert to TD (≥ 3 units/16 weeks per IWG 2018) Key secondary: Mean hemoglobin increase ≥ 1.5 g/dL + TI for at least 16 wks during Wk 1-48 Recruiting Expected data readout 2027 NCT05949684 ll Bristol Myers Squibb Q3 2023 Results Not for Product Promotional Use 42#43Oncology Hematology Cell Therapy Immunology Cardiovascular Onureg (Hypomethylating Agent) Indication Phase/Study (IPSS-R) Low-or Intermediate Risk MDS Phase II/III - METEOROID N = 230 # of Patients Design Endpoints Part I: • Onureg 200 mg, 300 mg in Phase II + Best Supportive Care Part II: • Onureg RP3D in Phase III + Best Supportive Care ⚫ Placebo Primary: Safety & Tolerability & RP3D (Phase II) Achieved Complete Remission per IWG 2006 within 6 cycles (Phase II & III) Key Secondary: 84-day pRBC TI (Phase II & III) • Recruiting Status Projected data readout 2026 CT Identifier lli Bristol Myers Squibb | Q3 2023 Results NCT05469737 Not for Product Promotional Use 43#44Oncology Hematology Cell Therapy Immunology Cardiovascular alnuctamab (BCMA x CD3 T-Cell Engager) Indication Phase/Study # of Patients Design Endpoints Status • alnuctamab 10, 30, 60 mg SC Primary: RP2D Safety and tolerability Data presented at ASH 2022 Projected data readout 2027 CT Identifier ll Bristol Myers Squibb Q3 2023 Results 4L+ MM Phase CC-93269-MM-001 N = 220 NCT03486067 Not for Product Promotional Use 44#45Breyanzi (anti-CD 19 CART) Indication Phase/Study # of Patients R/R NHL Phase I/II - TRANSCEND N = 385 • Breyanzi Design Study included R/R DLBCL, MCL, FL 3B, & PMBCL Primary: ORR Endpoints Positive topline results in R/R MCL in April 2023 Status . Data presented as Late Breaker at ICML 2023 in R/R MCL • CT Identifier NCT02631044 ll Bristol Myers Squibb Q3 2023 Results Oncology Hematology Cell Therapy Immunology Cardiovascular R/R iNHL Phase II TRANSCEND FL N = 213 3L+ CLL Phase II - TRANSCEND CLL N = 209 Breyanzi iNHL includes 3L+ FL, 2L FL (high risk), 3L+ MZL • . Primary: ORR Positive topline results in R/R FL in April 2023 Data presented as Late Breaker at ICML 2023 in R/R FL Projected data readout 2025 in 3L+ MZL NCT04245839 Breyanzi Breyanzi + ibrutinib Breyanzi + venetoclax • Primary: CRR • Met primary endpoint in monotherapy arm in January 2023 Data presented at ASCO 2023 NCT03331198 Not for Product Promotional Use 45#46Oncology Hematology Cell Therapy Immunology Cardiovascular Abecma (anti-BCMA CAR T) Indication Phase/Study # of Patients ⚫ Abecma 3L-5L MM Phase III - KarMMa-3 N = 381 Standard regimens as per Investigator's discretion - DPd, DVD, IRd, Kd, EPd NDMM with Suboptimal Response post-ASCT Phase III - KarMMa-9 N = 618 Abecma followed by lenalidomide maintenance Lenalidomide maintenance therapy alone Design Endpoints Primary: PFS • Key secondary: OS • U.S. PDUFA December 16, 2023 • Status . Application under review in EU & Japan Data presented at EHA EBMT 2023 Published in NEJM February 2023 CT Identifier ll Bristol Myers Squibb Q3 2023 Results NCT03651128 • Primary: PFS • ⚫ Key secondary: OS ⚫ Recruiting • Projected data readout 2027 NCT06045806 Not for Product Promotional Use 46#47cendakimab (anti-IL-13) Indication Phase/Study Eosinophilic Esophagitis (EOE) Phase III CC-93538-EE-001 Oncology Hematology Cell Therapy Immunology Cardiovascular Eosinophilic Gastroenteritis (EGE) (Japan study) Phase III CC-93538-EG-001 - # of Patients Design Endpoints Status CT Identifier N = 399 Cendakimab 360 mg SC QW for 24 weeks, followed by 360 mg SC QW for 24 weeks Cendakimab 360 mg SC QW for 24 weeks, followed by 360 mg SC Q2W for 24 weeks Placebo for 48 weeks Primary: Change in Dysphagia Days (clinical response) at week 24 Eosinophil histologic response (≤ 6/hpf) at week 24 Expected data readout 2024 NCT04753697 • Cendakimab for 48 weeks • Placebo for 48 weeks N = 45 Primary: Eosinophil histologic response (change from baseline) at week 16 Key secondary: clinical response up to week 48 Expected data readout 2024 NCT05214768 ll Bristol Myers Squibb Q3 2023 Results Not for Product Promotional Use 47#48LPA₁ antagonist Indication Phase/Study # of Patients Idiopathic Pulmonary Fibrosis Phase III IM027-068 - N = 1,185 LPA₁ Dose 60 mg BID LPA₁ Dose 120 mg BID Design Placebo Endpoints Status CT Identifier Oncology Hematology Cell Therapy Immunology Cardiovascular Progressive Pulmonary Fibrosis Phase III IM027-1015 N = 1,092 LPA₁ Dose 60 mg BID • LPA₁ Dose 120 mg BID Primary: Absolute change from baseline in forced vital capacity (FVC) measured in ML • Key secondary: Disease progression Recruiting Expected data readout 2026 • Placebo Primary: Absolute change from baseline in forced vital capacity (FVC) measured in ML Key secondary: Disease progression Recruiting Expected data readout 2028 ll Bristol Myers Squibb Q3 2023 Results NCT06003426 NCT06025578 Not for Product Promotional Use 48#49Sotyktu (TYK-2 inhibitor) Indication Phase/Study # of Patients Phase III - POETYK-PSA-1 N = 650 Oncology Hematology Cell Therapy Immunology Cardiovascular Psoriatic Arthritis (PSA) - Phase III POETYK-PSA-2 N = 700 52-week study of patients with active PSA in TNF-naïve patients • Sotyktu 6 mg QD • Placebo Design Primary: % pts achieving ACR20 response at Week 16 52-week study of patients with active PSA in TNF-naïve and TNF-IR patients • Sotyktu 6 mg QD Placebo ⚫ Apremilast Primary: % pts achieving ACR20 response at Week 16 Endpoints • Recruiting Status • Expected data readout 2025 (52 wks) CT Identifier ll Bristol Myers Squibb Q3 2023 Results NCT04908202 Expected data readout 2024 (52 wks) NCT04908189 Not for Product Promotional Use 49#50Sotyktu (TYK-2 inhibitor) Indication Oncology Hematology Cell Therapy Immunology Cardiovascular Systemic Lupus Erythematosus (SLE) Discoid Lupus Erythematosus (DLE) Sjogren's (SjS) Phase/Study Phase III POETYK SLE-1 Phase III - POETYK SLE-2 Phase II IM011-132 Phase III - POETYK SjS-1 # of Patients N = 490 N = 490 Sotyktu 3 mg BID Placebo • Sotyktu 3 mg BID • Placebo N = 75 N = 756 52-week study: Sotyktu Dose 1 ⚫ Sotyktu 3 mg BID Sotyktu 6 mg BID Design • Sotyktu Dose 2 • Placebo • Placebo Endpoints Primary: Proportion of participants who meet response criteria SRI-4 at week 52 Recruiting Primary: Proportion of participants who meet response criteria SRI-4 at week 52 Recruiting • Primary: Change from baseline in CLASI-A activity score at week 16 • Primary: Change from baseline in ESSDAI at week 52 Recruiting ⚫ Recruiting Status Expected data readout 2026 • Expected data readout 2026 • Expected data readout 2025 CT Identifier NCT05617677 NCT05620407 NCT04857034 Expected data readout 2027 NCT05946941 ll Bristol Myers Squibb Q3 2023 Results Not for Product Promotional Use 50#51Sotyktu (TYK-2 inhibitor) Oncology Hematology Cell Therapy Immunology Cardiovascular Alopecia Areata (AA) Phase II IM011-134 - N = 90 Indication Phase/Study # of Patients Design • • Sotyktu Dose 1 Sotyktu Dose 2 Placebo, followed by Sotyktu Dose 1 or Dose 2 Primary: Change from baseline in SALT score at Week 24 Endpoints • Expected data readout 2024 Status CT Identifier ll Bristol Myers Squibb Q3 2023 Results NCT05556265 Not for Product Promotional Use 51#52Zeposia (S1P agonist) Oncology Hematology Cell Therapy Immunology Cardiovascular Indication Phase/Study # of Patients YELLOWSTONE Program: Crohn's Disease (CD) - Moderate to Severe Phase III RPC01-3201 (Induction 1) N = 600 Zeposia 0.92 mg QD • Design • Placebo • Primary: Proportion of pts in clinical Phase III RPC01-3202 - (Induction 2) N = 606 Zeposia 0.92 mg QD • Placebo • - Phase III RPC01-3203 (Maintenance) N = 485 • Zeposia 0.92 mg QD • Placebo Endpoints Status CT Identifier remission (CDAI* score < 150) at week 12 . Expected data readout 2025 NCT03440372 Ill Bristol Myers Squibb Q3 2023 Results Primary: Proportion of pts in clinical remission (CDAI* score < 150) at week 12 Expected data readout 2024 • Primary: Proportion of pts in clinical remission (CDAI score of < 150) at week 52 Proportion of pts with a Simple Endoscopic Score for Crohn's Disease (SES-CD) decrease of ≥ 50% at week 52 Expected data readout 2026 (52 wks post induction & basis for filing) NCT03440385 NCT03464097 Not for Product Promotional Use 52#53Oncology Hematology Cell Therapy Immunology Cardiovascular obexelimab (CD19 x FcyRIIB bifunctional mAb) Indication Phase/Study # of Patients Obexelimab SC Placebo SC Design IgG4-Related Disease (ex-US study) Phase III INDIGO Non-BMS Sponsored* N = 200 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 • Recruiting Status Expected data readout 2025 CT Identifier NCT05662241 ll Bristol Myers Squibb Q3 2023 Results *Trial conducted by Zenas BioPharma Not for Product Promotional Use 53#54Oncology Hematology Cell Therapy Immunology Cardiovascular milvexian (FXla inhibitor) Indication Phase/Study # of Patients Design Endpoints Status CT Identifier Secondary Stroke Prevention Phase III - LIBREXIA-STROKE Non-BMS Sponsored* N = 15,000 • Milvexian 25 mg BID + background antiplatelet therapy • Placebo + background antiplatelet therapy • 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 Recruiting • Projected data readout 2026 (event driven) NCT05702034 ll Bristol Myers Squibb Q3 2023 Results Acute Coronary Syndrome Phase III LIBREXIA-ACS - Non-BMS Sponsored* N = 16,000 • Milvexian 25 mg BID + background antiplatelet therapy • Placebo + background antiplatelet therapy Note: participants enrolled within 7 days of ACS +/- catheterization Primary: Time to first occurrence of MACE Key secondary: Non-Valvular Atrial Fibrillation 1 Phase III LIBREXIA-AF Non-BMS Sponsored* N = 15,500 • Milvexian 100 mg BID Eliquis • Primary: Time to first occurrence of composite endpoint of stroke & non-CNS system embolism Time to first occurrence of any component Key secondary: of the composite of MAVE • ⚫ Recruiting Projected data readout 2026 (event driven) *Trials conducted by Janssen NCT05754957 Time to first occurrence of ISTH major bleeding Time to first occurrence of the composite of ISTH major & CRNM bleeding ⚫ Recruiting Projected data readout 2027 (event driven) NCT05757869 Not for Product Promotional Use 54#55Oncology Hematology Cell Therapy Immunology Cardiovascular Camzyos (myosin inhibitor) Indication Phase/Study # of Patients Heart Failure with Preserved Ejection Fraction (HFPEF) Phase II EMBARK - N = 35 Non-Obstructive Hypertrophic Cardiomyopathy (nHCM) Phase III ODYSSEY-HCM - N = 420 Camzyos Design Primary: TEAES and SAES Effect on NT-proBNP levels Endpoints Effect on cTnT levels (at rest) • Camzyos • Placebo Primary: • Change from baseline in Clinical Summary Score (KCCQ-23 CSS) at Week 48 • Change from baseline in peak oxygen consumption (PVO2) at Week 48 Secondary: Change from baseline in VE/VCO2 slope to Week 48 Status Projected data readout 2024 CT Identifier ll Bristol Myers Squibb Q3 2023 Results NCT04766892 • Recruiting . Projected data readout 2025 NCT05582395 Not for Product Promotional Use 55#56Abbreviations AA Alopecia Areata EoE Eosinophilic Esophagitis MTD Maximum Tolerated Dose RP3D Recommended Phase 3 Dose American Association for Cancer AACR ESA Erythropoietin Stimulating Agents MZL Marginal Zone Lymphoma ROS C-ROS Oncogene Research Adj Adjuvant ESCC Esophageal Squamous Cell Carcinoma nHCM Non-Obstructive Hypertrophic Cardiomyopathy RR Relapsed Refractory AE Adverse Event FDC Fixed Dose Combination ND Newly Diagnosed SAE Serious Adverse Event AHA American Heart Association FDA Food & Drug Administration NSCLC Non-Small Cell Lung Cancer SC Subcutaneous AML Acute Myeloid Leukemia FL Follicular Lymphoma NTD Non-Transfusion Dependent SCT Stem Cell Transplant ASH American Society of Hematology Hb Hemoglobin NTRK Neurotrophic Tyrosine Receptor Kinase SLE Systemic Lupus Erythematosus BCMA B-Cell Maturation Antigen HCC Hepatocellular Carcinoma NYHA New York Health Association SoC Standard of Care BID Twice a Day HFPEF Heart Failure w/ Preserved Ejection Fraction OHCM Obstructive Hypertrophic Cardiomyopathy SPGA Static Physicians Global Assessment BIW Twice a week iNHL Indolent Non-Hodgkin's Lymphoma ORR Overall Response Rate SRI Systemic Lupus Responder Index CAR T Chimeric Antigen Receptor Therapy 1-0 Immuno-Oncology OS Overall Survival SRT Septal Reduction Therapy CCRT CD Concurrent Chemoradiation Therapy Crohn's Disease IPSS-R IV International Prognostic Scoring System Intravenous PASI Psoriasis Area and Severity Index SSP Secondary Stroke Prevention PCR Pathological Complete Response SubQ/SC Subcutaneous CDAI Crohn's Disease Activity Index LBCL Large B-Cell Lymphoma PDCT Platinum-Based Chemotherapy TD Transfusion Dependent CLL CM Chronic Lymphocytic Leukemia Checkmate LVOT Left Ventricular Outflow Tract PDL Programmed Death Ligand TE Transplant Eligible mCRPC Metastatic Castration-Resistant Prostate Cancer PDUFA Prescription Drug User Fee Act TEAE Treatment Emergent Adverse Events CR Complete Response MDS Myelodysplastic Syndrome PF Pulmonary Fibrosis TKI Tyrone Kinase Inhibitor CRR Complete Remission Rate CRC Colorectal Cancer Mel mDSD modified Daily Symptom Diary Melanoma PFS Progression Free Survival TRAE POC Proof of Concept TE Treatment Related Adverse Events Transplant Eligible DFS Disease-free survival MF Myelofibrosis PsA Psoriatic Arthritis TNF Tumor Necrosis Factor DLBCL Diffuse Large B-Cell Lymphoma MIUC Muscle Invasive Urothelial Cancer PsO Psoriasis UC Ulcerative Colitis DLE Discoid Lupus Erythematosus MM Multiple Myeloma QD Once Daily VO2 Volume of Oxygen DLT Dose Limiting Toxicity MR EADV European Academy of Dermatology and Venereology MS Minimal Response Multiple Sclerosis QW Once Weekly RBC-TI Red Blood Cell Transfusion Independence EASI Eczema Area & Severity Index MSI-H High Microsatellite Instability RCC Renal Cell Carcinoma EFS Event Free Survival MSS Microsatellite Stable RFS Recurrence-free survival ll Bristol Myers Squibb™ | Q3 2023 Results RP2D Recommended Phase 2 Dose Not for Product Promotional Use 56

Download to PowerPoint

Download presentation as an editable powerpoint.

Related

Q4 & FY22 - Investor Presentation image

Q4 & FY22 - Investor Presentation

Financial Services

FY23 Results - Investor Presentation image

FY23 Results - Investor Presentation

Financial Services

Ferocious - Plant Growth Optimizer image

Ferocious - Plant Growth Optimizer

Agriculture

Market Outlook and Operational Insights image

Market Outlook and Operational Insights

Metals and Mining

2023 Investor Presentation image

2023 Investor Presentation

Financial

Leveraging EdTech Across 3 Verticals image

Leveraging EdTech Across 3 Verticals

Technology

Axis 2.0 Digital Banking image

Axis 2.0 Digital Banking

Sustainability & Digital Solutions

Capital One’s acquisition of Discover image

Capital One’s acquisition of Discover

Mergers and Acquisitions