Cabozantinib (s)-Malate

PRINCETON, N.J.--( BUSINESS WIRE )-- Bristol Myers Squibb (NYSE: BMY) today reports results for the fourth quarter and full year of 2024. “ We made good progress in 2024, which was capped by a fourth quarter of strong topline growth driven by key products and important pipeline advancements. We also achieved the landmark U.S. approval of Cobenfy last year for the treatment of schizophrenia in adults, and we expect this medicine to have a meaningful impact on patients and the company as a new growth driver,” said Christopher Boerner, Ph.D. , board chair and chief executive officer, Bristol Myers Squibb. “ Our collective focus on execution has established a solid foundation to navigate the multi-year journey toward achieving top-tier sustainable growth and long-term shareholder returns.” Fourth Quarter $ in millions, except per share amounts 2024 2023 Change Change Excl. F/X** Total Revenues $12,342 $11,477 8% 9% Earnings Per Share - GAAP* 0.04 0.87 (95)% N/A Earnings Per Share - Non-GAAP* 1.67 1.70 (2)% N/A Acquired IPRD Charge and Licensing Income Net Impact on Earnings Per Share 0.01 (0.20 ) N/A N/A *GAAP and Non-GAAP earnings per share include the net impact of Acquired IPRD charges and licensing income. **See "Use of Non-GAAP Financial Information". Full Year $ in millions, except per share amounts 2024 2023 Change Change Excl. F/X** Total Revenues $48,300 $45,006 7% 9% (Loss)/Earnings Per Share - GAAP* (4.41 ) 3.86 N/A N/A Earnings Per Share - Non-GAAP* 1.15 7.51 (85)% N/A Acquired IPRD Charge and Licensing Income Net Impact on Earnings Per Share (6.39 ) (0.28 ) N/A N/A *GAAP and Non-GAAP earnings per share include the net impact of Acquired IPRD charges and licensing income. **See "Use of Non-GAAP Financial Information". FOURTH QUARTER RESULTS All comparisons are made versus the same period in 2023 unless otherwise stated. Bristol Myers Squibb posted fourth quarter revenues of $12.3 billion, an increase of 8%, or 9% when adjusted for foreign exchange impacts, primarily driven by the Growth Portfolio and higher demand for Eliquis , partially offset by the impact of generics on Sprycel, Revlimid, Abraxane and Pomalyst . U.S. revenues increased 9% to $8.6 billion, primarily driven by higher demand for the Growth Portfolio and Eliquis , partially offset by the impact of generics within the Legacy Portfolio. International revenues increased 5% to $3.7 billion, or 9% when adjusted for foreign exchange impacts, primarily driven by higher demand for the Growth Portfolio, partially offset by the impact of generics within the Legacy Portfolio. On a GAAP basis, gross margin decreased from 76.1% to 61.0%, primarily driven by intangible asset impairment charges and product mix. On a non-GAAP basis, gross margin decreased from 76.4% to 74.0%, primarily due to product mix. On a GAAP and non-GAAP basis, marketing, selling and administrative expenses remained relatively flat at $2.1 billion. On a GAAP basis, research and development expenses increased 29% to $3.2 billion, primarily due to the impact of recent acquisitions and IPRD impairment charges. On a non-GAAP basis, research and development expenses increased 13% to $2.8 billion, primarily due to the impact of recent acquisitions. On a GAAP and non-GAAP basis, Acquired IPRD decreased to $30 million from $600 million. On a GAAP and non-GAAP basis, licensing income was $48 million compared to $67 million. On a GAAP basis, amortization of acquired intangible assets decreased 26% to $1.7 billion, primarily due to lower amortization expense related to Revlimid , partially offset by the RayzeBio acquisition in 2024. On a GAAP basis, the effective tax rate was 56.6%, primarily due to the impact of intangible asset impairments and amortization of acquired intangible assets. In 2023, the income tax benefit was $88 million despite pre-tax earnings of $1.7 billion, primarily due to a valuation allowance reversal and foreign currency. On a non-GAAP basis, the effective tax rate changed from 14.9% to 19.9%, primarily due to jurisdictional earnings mix. On a GAAP basis, the company reported net income attributable to Bristol Myers Squibb of $72 million, or $0.04 per share, during the fourth quarter of 2024 compared to net earnings of $1.8 billion, or $0.87 per share, for the same period a year ago. The company reported non-GAAP net earnings attributable to Bristol Myers Squibb of $3.4 billion, or $1.67 per share, during the fourth quarter of 2024 compared to $3.5 billion, or $1.70 per share, for the same period a year ago. FOURTH QUARTER PRODUCT REVENUE HIGHLIGHTS ($ amounts in millions) Quarter Ended December 31, 2024 % Change from Quarter Ended December 31, 2023 % Change from Quarter Ended December 31, 2023 Ex-F/X** U.S. Int'l (c) WW (d) U.S. Int'l (c) WW (d) Int'l (c) WW (d) Growth Portfolio Opdivo $ 1,423 $ 1,056 $ 2,479 2% 7% 4% 15% 7% Orencia 750 250 1,000 (1)% 9% 2% 15% 3% Yervoy 428 247 675 26% 9% 19% 15% 22% Reblozyl 445 102 547 65% 104% 71% 110% 72% Opdualag 233 21 254 25% >200% 34% >200% 34% Breyanzi 209 54 263 146% >200% 160% >200% 162% Camzyos 201 22 223 142% >200% 153% >200% 153% Zeposia 115 43 158 15% 30% 19% 33% 20% Abecma 59 46 105 5% 5% 5% 5% 5% Sotyktu 64 19 83 14% 171% 32% 171% 32% Krazati 36 3 39 N/A N/A N/A N/A N/A Augtyro 13 2 15 >200% N/A >200% N/A >200% Cobenfy 10 — 10 N/A N/A N/A N/A N/A Other Growth Products (a) 186 326 512 13% 104% 58% 106% 59% Total Growth Portfolio 4,172 2,191 6,363 19% 24% 21% 31% 23% Legacy Portfolio Eliquis 2,221 974 3,195 19% (3)% 11% (2)% 11% Revlimid 1,169 170 1,339 (6)% (17)% (8)% (15)% (7)% Pomalyst/Imnovid 685 138 823 9% (48)% (8)% (47)% (7)% Sprycel 135 63 198 (67)% (45)% (62)% (41)% (61)% Abraxane 91 83 174 (48)% 17% (30)% 28% (26)% Other Legacy Products (b) 123 127 250 46% (14)% 8% (15)% 7% Total Legacy Portfolio 4,424 1,555 5,979 —% (14)% (4)% (12)% (3)% Total Revenues $ 8,596 $ 3,746 $ 12,342 9% 5% 8% 9% 9% ** See "Use of Non-GAAP Financial Information". (a) Includes Nulojix, Onureg, Inrebic, Empliciti and royalty revenue. (b) Includes other mature brands. (c) Beginning in 2024, Puerto Rico revenues are included in International revenues. Prior period amounts have been reclassified to conform to the current presentation. (d) Worldwide (WW) includes U.S. and International (Int'l). FOURTH QUARTER PRODUCT REVENUE HIGHLIGHTS Growth Portfolio Growth Portfolio worldwide revenues increased to $6.4 billion compared to $5.3 billion in the prior year period, representing growth of 21% on a reported basis, or 23% when adjusted for foreign exchange impacts. Growth Portfolio revenues were primarily due to higher demand for Reblozyl, Breyanzi , Camzyos , Yervoy and Opdualag. Legacy Portfolio Revenues for the Legacy Portfolio in the fourth quarter were $6.0 billion compared to $6.2 billion in the prior year period, representing a decline of 4% on a reported basis and 3% when adjusted for foreign exchange impacts. Legacy Portfolio revenues were lower primarily due to the impact of generics on Sprycel, Revlimid, Abraxane and Pomalyst , partially offset by higher demand for Eliquis . PRODUCT AND PIPELINE UPDATE Neuroscience Category Asset Milestone Clinical & Research Cobenfy TM (xanomeline and trospium chloride) Long-term data from the Phase 3 EMERGENT-4 and EMERGENT-5 trials evaluating Cobenfy in adults with schizophrenia showed that Cobenfy was generally well tolerated over 52 weeks, with continued improvements in symptoms and a side effect profile consistent with prior trials of the treatment in this indication. Oncology Category Asset Milestone Regulatory Opdivo ® (nivolumab) + Yervoy ® (ipilimumab) The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of Opdivo + Yervoy for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma. The recommendation is based on results of the Phase 3 CheckMate -9DW trial. The CHMP opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union. Augtyro TM (repotrectinib)* The EC approved Augtyro , a next-generation tyrosine kinase inhibitor (TKI), as a treatment for adult patients with ROS1-positive advanced non-small cell lung cancer and for the treatment of adult and pediatric patients 12 years of age and older with advanced solid tumors expressing a NTRK gene fusion, and who have received a prior NTRK inhibitor, or have not received a prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit, or have been exhausted. The approval is based on results from the TRIDENT-1 and CARE trials. *Approval received on January 13, 2025, and announced today by the company. Opdivo Qvantig TM (nivolumab and hydaluronidase-nyhy) The U.S. Food and Drug Administration (FDA) approved Opdivo Qvantig injection for subcutaneous use in most previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance after completion of Opdivo plus Yervoy combination therapy, or in combination with chemotherapy or cabozantinib. The approval is based on results from the Phase 3 randomized, open-label CheckMate -67T trial. Opdivo + Yervoy The EC approved Opdivo plus Yervoy for the first-line treatment of adult patients with microsatellite instability-high or mismatch repair deficient unresectable or metastatic colorectal cancer (mCRC). The approval is based on results from the CheckMate -8HW trial. Clinical & Research Opdivo + Yervoy Results from an analysis of the Phase 3 CheckMate -8HW trial evaluating Opdivo plus Yervoy versus Opdivo monotherapy across all lines of therapy for microsatellite instability-high/mismatch repair-deficient mCRC demonstrated a statistically significant and clinically meaningful improvement at a median follow up of 47 months in the dual primary endpoint of progression-free survival as assessed by Blinded Independent Central Review. Hematology Category Asset Milestone Clinical & Research Breyanzi ® (lisocabtagene maraleucel) Five-year overall survival data from the Phase 1 TRANSCEND NHL 001 study supported deep and durable responses of Breyanzi in patients with relapsed or refractory large B-cell lymphoma (LBCL) with median overall survival (OS) of 27.5 months and an estimated OS rate at five years of 38 percent. Breyanzi continued to demonstrate an established safety profile with no new safety signals. In addition, new circulating tumor DNA (ctDNA) from the Phase 3 TRANSFORM study supported the superiority of Breyanzi to achieve deeper responses over the former standard of care in second-line LBCL. Regulatory Breyanzi The CHMP of the EMA recommended approval of Breyanzi for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. The recommendation is based on data from the Phase 2 TRANSCEND FL study. The CHMP opinion will now be reviewed by the EC. Cardiovascular Category Asset Milestone Clinical & Research Camzyos ® (mavacamten) In Europe, following an opinion from the CHMP of the EMA, Camzyos received a label update to reduce the frequency of required echocardiography monitoring once a patient treated for obstructive hypertrophic cardiomyopathy is on a stable dose. In addition, the company is today announcing the receipt of an April Prescription Drug User Fee Act (PDUFA) goal date from the FDA in the same setting. Immunology Category Asset Milestone Clinical & Research Sotyktu ® (deucravacitinib) Results from the Phase 3 POETYK PsA-1 and POETYK PsA-2 trials evaluating the efficacy and safety of Sotyktu in adults with active psoriatic arthritis (PsA) met their primary endpoint, with a significantly greater proportion of Sotyktu -treated patients achieving at least a 20 percent improvement in signs and symptoms of disease after 16 weeks of treatment compared with placebo. In addition, both trials met secondary endpoints across PsA disease activity at Week 16. In both studies, Sotyktu was well-tolerated and demonstrated safety consistent with the established safety profile of Sotyktu observed in a Phase 2 PsA clinical trial and Phase 3 moderate-to-severe plaque psoriasis clinical trials. FULL-YEAR FINANCIAL RESULTS All comparisons are made versus the same period in 2023 unless otherwise stated. Bristol Myers Squibb posted revenues of $48.3 billion, an increase of 7%, or 9% when adjusted for foreign exchange impacts, primarily driven by the Growth Portfolio and higher demand for Eliquis , partially offset by the impact of generics on Sprycel, Revlimid and Abraxane . U.S. revenues increased 9% to $34.1 billion, primarily due to higher demand for the Growth Portfolio and Eliquis , partially offset by the impact of generics on Sprycel, Revlimid and Abraxane . International revenues increased 3% to $14.2 billion, or 8.0% when adjusted for foreign exchange impacts, primarily due to demand for Growth Portfolio products, partially offset by the impact of generics within the Legacy Portfolio. On a GAAP basis, gross margin decreased from 76.2% to 71.1%, primarily driven by intangible asset impairment charges and product mix. On a non-GAAP basis, gross margin decreased from 76.6% to 75.3%, primarily due to product mix. On a GAAP and non-GAAP basis, marketing, selling and administrative expenses increased 8% to $8.4 billion and 4% to $8.0 billion, respectively. The increase is primarily due to the timing of spend and the impact of recent acquisitions. On a GAAP basis, research and development expenses increased 20% to $11.2 billion, primarily due to the impact of recent acquisitions and IPRD impairment charges. On a non-GAAP basis, research and development expenses increased 7% to $9.8 billion, primarily due to the impact of recent acquisitions. On a GAAP and non-GAAP basis, Acquired IPRD increased from $913 million to $13.4 billion driven by a one-time Acquired IPRD charge from the Karuna asset acquisition and SystImmune collaboration. On a GAAP and non-GAAP basis, licensing income was $122 million during the year compared to $142 million in 2023. On a GAAP basis, amortization of acquired intangible assets decreased 2% to $8.9 billion, primarily due to lower amortization expense related to Revlimid , partially offset by the RayzeBio acquisition in 2024. On a GAAP basis, income tax expense was $554 million despite a pre-tax loss of $8.4 billion, primarily due to a $12.1 billion non-tax deductible charge for the Karuna acquisition. The 2023 GAAP effective tax rate was impacted by a non-U.S. tax ruling on statutory impairment deductibility, changes in tax reserves, valuation allowances, and IRS guidance on non-U.S. R&D expense deductibility. On a non-GAAP basis, the effective tax rate increased from 14.7% to 56.8%, primarily due to the non-tax deductible charge. The company reported on a GAAP basis net loss attributable to Bristol Myers Squibb of $8.9 billion, or $(4.41) per share, compared to earnings attributable to Bristol Myers Squibb of $8.0 billion, or $3.86 per share for the same period a year ago. On a non-GAAP basis the company reported net earnings attributable to Bristol Myers Squibb of $2.3 billion, or $1.15 per share, compared to earnings attributable to Bristol Myers Squibb of $15.6 billion, or $7.51 per share for the same period a year ago. In addition to the non-GAAP drivers noted above, non-GAAP EPS was impacted by higher interest expense. FULL-YEAR PRODUCT REVENUE HIGHLIGHTS ($ amounts in millions) Year Ended December 31, 2024 % Change from Year Ended December 31, 2023 % Change from Year Ended December 31, 2023 Ex-F/X** U.S. Int'l (c) WW (d) U.S. Int'l (c) WW (d) Int'l (c) WW (d) Growth Portfolio Opdivo $ 5,350 $ 3,954 $ 9,304 2% 5% 3% 14% 7% Orencia 2,770 912 3,682 2% 2% 2% 10% 4% Yervoy 1,599 931 2,530 16% 8% 13% 15% 16% Reblozyl 1,444 329 1,773 80% 61% 76% 65% 77% Opdualag 870 58 928 41% >200% 48% >200% 48% Breyanzi 591 156 747 95% 156% 105% 162% 106% Camzyos 543 59 602 141% >200% 161% >200% 161% Zeposia 403 163 566 26% 42% 30% 42% 30% Abecma 242 164 406 (32)% 44% (14)% 47% (13)% Sotyktu 190 56 246 21% >200% 45% >200% 46% Krazati 118 8 126 N/A N/A N/A N/A N/A Augtyro 36 2 38 >200% N/A >200% N/A >200% Cobenfy 10 — 10 N/A N/A N/A N/A N/A Other Growth Products (a) 674 931 1,605 9% 58% 33% 61% 34% Total Growth Portfolio 14,840 7,723 22,563 17% 16% 17% 24% 19% Legacy Portfolio Eliquis 9,631 3,702 13,333 14% (1)% 9% —% 9% Revlimid 4,999 774 5,773 (4)% (14)% (5)% (11)% (5)% Pomalyst/Imnovid 2,695 850 3,545 15% (23)% 3% (22)% 3% Sprycel 983 303 1,286 (31)% (40)% (33)% (36)% (32)% Abraxane 541 334 875 (23)% 11% (13)% 25% (8)% Other Legacy Products (b) 416 509 925 25% (19)% (4)% (18)% (3)% Total Legacy Portfolio 19,265 6,472 25,737 4% (10)% —% (8)% 1% Total Revenues $ 34,105 $ 14,195 $ 48,300 9% 3% 7% 8% 9% ** See "Use of Non-GAAP Financial Information". (a) Includes Nulojix, Onureg, Inrebic, Empliciti and royalty revenue. (b) Includes other mature brands. (c) Beginning in 2024, Puerto Rico revenues are included in International revenues. Prior period amounts have been reclassified to conform to the current presentation. (d) Worldwide (WW) includes U.S. and International (Int'l). FULL-YEAR PRODUCT REVENUE HIGHLIGHTS Growth Portfolio Growth Portfolio worldwide revenues increased to $22.6 billion compared to $19.4 billion in the prior year period, representing growth of 17% on a reported basis, or 19% when adjusted for foreign exchange impacts. Growth Portfolio revenues were primarily driven by higher demand for Reblozyl, Breyanzi , Camzyos and Opdualag. Legacy Portfolio Revenues for the Legacy Portfolio remained relatively flat at $25.7 billion compared to $25.6 billion in the prior year period, and increased 1% when adjusted for foreign exchange impacts. Legacy Portfolio revenues were primarily driven by higher demand for Eliquis , offset by the impact of generics on Sprycel, Revlimid, Abraxane and Pomalyst . Update on Strategic Productivity Initiative Bristol Myers Squibb is expanding its existing strategic productivity initiative to include approximately $2 billion in additional annualized cost savings by the end of 2027. Under this expanded initiative, savings will be driven by changes in organizational design and efforts to enhance operational efficiency. These savings will be removed from our cost structure to contribute to a leaner, more efficient company while investing behind growth brands and promising areas of science. Financial Guidance Bristol Myers Squibb is providing key 2025 non-GAAP line-item guidance assumptions as outlined below. We estimate total revenues to be approximately $45.5 billion, reflecting, as previously expected, the near-term impact of generics across Revlimid , Pomalyst , Sprycel and Abraxane , which we expect to result in a revenue decline of approximately 18-20% of the Legacy Portfolio. This is expected to be partially offset by the continued strength of our Growth Portfolio. This guidance also reflects an approximate $500 million expected negative impact to revenue due to foreign exchange. 2025 Non-GAAP 1 Line-Item Guidance Total Revenues (Reported & Ex-F/X) ~$45.5 billion Gross Margin % ~72% Operating Expenses 2 ~$16 billion Other Income/(Expense) ~$30 million Tax Rate ~18% Diluted EPS $6.55-$6.85 1 See "Use of Non-GAAP Financial Information." 2 Operating Expenses = MS&A and R&D, excluding Acquired IPRD and Amortization of acquired intangible assets. The 2025 financial guidance excludes the impact of any potential future strategic acquisitions, divestitures, specified items that have not yet been identified and quantified, and the impact of future Acquired IPRD charges. To the extent we have quantified the impact of significant R&D charges or other income resulting from upfront or contingent milestone payments in connection with asset acquisitions or licensing of third-party intellectual property rights, we may update this information from time to time on our website www.bms.com , in the "Investors" section. Non-GAAP guidance assumes current exchange rates. The financial guidance is subject to risks and uncertainties applicable to all forward-looking statements as described elsewhere in this press release. A reconciliation of forward-looking non-GAAP measures, including non-GAAP 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. See "Cautionary Statement Regarding Forward-Looking Statements" and "Use of Non-GAAP Financial Information." Conference Call Information Bristol Myers Squibb will host a conference call today, Thursday, February 6, 2025, at 8:00 a.m. ET, during which company executives will review quarterly and annual financial results and address inquiries from investors and analysts. Investors and the general public are invited to listen to a live webcast of the call at http://investor.bms.com . Investors and the public can register for the live conference call here . Those unable to register can access the live conference call by dialing in the U.S. toll-free 1-833-816-1116 or international +1 412-317-0705. Materials related to the call will be available at http://investor.bms.com prior to the start of the conference call. A replay of the webcast will be available at http://investor.bms.com approximately three hours after the conference call concludes. A replay of the conference call will be available beginning at 11:30 a.m. ET on February 6, 2025, through 11:30 a.m. ET on February 20, 2025, by dialing in the U.S. toll free 1-877-344-7529 or international +1 412-317-0088, confirmation code: 5943651. About Bristol Myers Squibb Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn , X , YouTube , Facebook , and Instagram . corporatefinancial-news Use of Non-GAAP Financial Information In discussing financial results and guidance, the company refers to financial measures that are not in accordance with U.S. Generally Accepted Accounting Principles (GAAP). The non-GAAP financial measures are provided as supplemental information to the financial measures presented in this press release that are calculated and presented in accordance with GAAP 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. In addition, non-GAAP gross margin, which is gross profit excluding certain specified items, as a percentage of revenues, non-GAAP operating margin, which is gross profit less marketing, selling and administrative expenses and research and development expenses excluding certain specified items as a percentage of revenues, non-GAAP operating expenses, which is marketing, selling and administrative and research and development expenses excluding certain specified items, non-GAAP marketing, selling and administrative expenses, which is marketing, selling and administrative expenses excluding certain specified items, and non-GAAP research and development expenses, which is research and development expenses excluding certain specified items, are relevant and useful for investors because they allow investors to view performance in a manner similar to the method used by our management and make it easier for investors, analysts and peers to compare our operating performance to other companies in our industry and to compare our year-over-year results. This earnings release and the accompanying tables also provide certain revenues and expenses, as well as non-GAAP measures, excluding the impact of foreign exchange ("Ex-Fx"). We calculate foreign exchange impacts by converting our current-period local currency financial results using the prior period average currency rates and comparing these adjusted amounts to our current-period results. Ex-Fx financial measures are not accounted for according to GAAP because they remove the effects of currency movements from GAAP results. Non-GAAP financial measures such as non-GAAP earnings and related EPS information are adjusted to exclude certain costs, expenses, gains and losses and other specified items that are evaluated on an individual basis after considering their quantitative and qualitative aspects and typically have one or more of the following characteristics, such as being highly variable, difficult to project, unusual in nature, significant to the results of a particular period or not indicative of past or future operating results. These items are excluded from non-GAAP earnings and related EPS information because the company believes they neither relate to the ordinary course of the company’s business nor reflect the company’s underlying business performance. Similar charges or gains were recognized in prior periods and will likely reoccur in future periods, including amortization of acquired intangible assets, including product rights that generate a significant portion of our ongoing revenue and will recur until the intangible assets are fully amortized, unwinding of inventory purchase price adjustments, acquisition and integration expenses, restructuring costs, accelerated depreciation and impairment of property, plant and equipment and intangible assets, costs of acquiring a priority review voucher, divestiture gains or losses, stock compensation resulting from acquisition-related equity awards, pension, legal and other contractual settlement charges, equity investment and contingent value rights fair value adjustments (including fair value adjustments attributed to limited partnership equity method investments), income resulting from the change in control of the Nimbus Therapeutics TYK2 Program and amortization of fair value adjustments of debt acquired from Celgene in our 2019 exchange offer, among other items. Deferred and current income taxes attributed to these items are also adjusted for considering their individual impact to the overall tax expense, deductibility and jurisdictional tax rates. Certain other significant tax items are also excluded such as the impact resulting from a non-U.S. tax ruling regarding the deductibility of a statutory impairment of subsidiary investments and release of income tax reserves relating to the Celgene acquisition. Because the non-GAAP financial measures are not calculated in accordance with GAAP, they should not be considered superior to and are not intended to be considered in isolation or as a substitute for the related financial measures presented in the press release that are prepared in accordance with GAAP and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted. We encourage investors to review our financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure. Reconciliations of the non-GAAP financial measures to the most comparable GAAP measures are provided in the accompanying financial tables and will also be available on the company’s website at www.bms.com . Within the accompanying financial tables presented, certain columns and rows may not add due to the use of rounded numbers. Percentages and EPS amounts presented are calculated from the underlying amounts. A reconciliation of forward-looking non-GAAP measures, including non-GAAP 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. Website Information We routinely post important information for investors on our website, BMS.com, in the “Investors” section. We may use this website as a means of disclosing material, non-public information and for complying with our disclosure obligations under Regulation FD. Accordingly, investors should monitor the Investors section of our website, in addition to following our press releases, Securities and Exchange Commission (SEC) filings, public conference calls, presentations and webcasts. We may also use social media channels to communicate with our investors and the public about our company, our products and other matters, and those communications could be deemed to be material information. The information contained on, or that may be accessed through, our website or social media channels are not incorporated by reference into, and are not a part of, this document. Cautionary Statement Regarding Forward-Looking Statements This earnings release and the related attachments (as well as the oral statements made with respect to information contained in this release and the attachments) contain certain “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, regarding, among other things, the company’s 2025 financial guidance, its Strategic Productivity Initiative, its business development and capital allocation strategy, anticipated developments in the company’s pipeline, expectations with respect to the company’s future market position and the projected benefits of the company’s alliances and other business development activities. These statements may be identified by the fact that they use words such as “should,” “could,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe,” “will” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance, although not all forward-looking statements contain such terms. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. No forward-looking statement can be guaranteed, and there is no assurance that the company will achieve its financial guidance and long-term targets, that the company’s future clinical studies will support the data described in this release, that the company’s product candidates will receive necessary clinical and manufacturing regulatory approvals, that the company’s pipeline products will prove to be commercially successful, that clinical and manufacturing regulatory approvals will be sought or obtained within currently expected timeframes, or that contractual milestones will be achieved. Forward-looking statements are based on current expectations and projections about the company’s future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond the company’s control and could cause the company’s future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. Such risks, uncertainties and other matters include, but are not limited to: increasing pricing pressures from market access, pharmaceutical pricing controls and discounting; market actions taken by private and government payers to manage drug utilization and contain costs; the company’s ability to retain patent and market exclusivity for certain products; regulatory changes that result in lower prices, lower reimbursement rates and smaller populations for whom payers will reimburse; changes under the 340B Drug Pricing Program; the company’s ability to obtain and maintain regulatory approval for its product candidates; the possibility of difficulties and delays in product introduction and commercialization; increasing industry competition; potential difficulties, delays and disruptions in manufacturing, distribution or sale of products; the company’s ability to identify potential strategic acquisitions, licensing opportunities or other beneficial transactions; failure to complete, or delays in completing, collaborations, acquisitions, divestitures, alliances and other portfolio actions and the failure to achieve anticipated benefits from such transactions and actions; exposure to litigation and/or regulatory actions or investigations; the impact of any healthcare reform and legislation or regulatory action in the United States and international markets; increasing market penetration of lower-priced generic products; the failure of the company’s suppliers, vendors, outsourcing partners, alliance partners and other third parties to meet their contractual, regulatory and other obligations; the impact of counterfeit or unregistered versions of the company’s products and from stolen products; product label changes or other measures that could result in declining sales; safety or efficacy concerns regarding the company’s products or any product in the same class as the company’s products; the risk of cyber-attacks and unauthorized disclosure of trade secrets or other confidential data; the company’s ability to execute its financial, strategic and operational plans; the company’s ability to attract and retain key personnel; the impact of the company’s significant indebtedness; political and financial instability of international economies and sovereign risk; interest rate and currency exchange rate fluctuations, credit and foreign exchange risk management; risks relating to the use of social media platforms; issuance of new or revised accounting standards; and risks relating to public health outbreaks, epidemics and pandemics. Forward-looking statements in this earnings release should be evaluated together with the many risks and uncertainties that affect the company’s business and market, particularly those identified in the cautionary statement and risk factors discussion in the company’s Annual Report on Form 10-K for the year ended December 31, 2023, as updated by the company’s subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, the company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise. BRISTOL-MYERS SQUIBB COMPANY CONSOLIDATED STATEMENTS OF EARNINGS (Unaudited, dollars and shares in millions except per share data) Three Months Ended December 31, Twelve Months Ended December 31, 2024 2023 2024 2023 Net product sales $ 11,811 $ 11,168 $ 46,778 $ 43,778 Alliance and other revenues 531 309 1,522 1,228 Total Revenues 12,342 11,477 48,300 45,006 Cost of products sold (a) 4,812 2,745 13,968 10,693 Marketing, selling and administrative 2,136 2,073 8,414 7,772 Research and development 3,191 2,478 11,159 9,299 Acquired IPRD 30 600 13,373 913 Amortization of acquired intangible assets 1,693 2,278 8,872 9,047 Other (income)/expense, net 305 (371 ) 893 (1,158 ) Total Expenses 12,167 9,803 56,679 36,566 (Loss)/Earnings Before Income Taxes 175 1,674 (8,379 ) 8,440 Provision for Income Taxes 99 (88 ) 554 400 Net (Loss)/Earnings 76 1,762 (8,933 ) 8,040 Noncontrolling Interest 4 — 15 15 Net (Loss)/Earnings Attributable to BMS $ 72 $ 1,762 $ (8,948 ) $ 8,025 Weighted-Average Common Shares Outstanding: Basic 2,029 2,027 2,027 2,069 Diluted 2,037 2,033 2,027 2,078 (Loss)/Earnings per Common Share: Basic $ 0.04 $ 0.87 $ (4.41 ) $ 3.88 Diluted 0.04 0.87 (4.41 ) 3.86 Other (income)/expense, net Interest expense (b) $ 496 $ 316 $ 1,947 $ 1,166 Royalty income - divestitures (284 ) (239 ) (1,104 ) (862 ) Royalty and licensing income (204 ) (420 ) (736 ) (1,488 ) Provision for restructuring 77 44 635 365 Investment income (114 ) (145 ) (478 ) (449 ) Integration expenses 70 62 284 242 Litigation and other settlements 13 3 84 (390 ) Acquisition expense — 32 50 32 Intangible asset impairments — — 47 29 Equity investment (gains)/losses 205 (53 ) (16 ) 160 Divestiture losses 10 — 15 — Other 36 29 165 37 Other (income)/expense, net $ 305 $ (371 ) $ 893 $ (1,158 ) (a) Excludes amortization of acquired intangible assets. (b) Includes amortization of purchase price adjustments to Celgene debt. BRISTOL-MYERS SQUIBB COMPANY PRODUCT REVENUES FOR THE THREE MONTHS ENDED DECEMBER 31, 2024 AND 2023 (Unaudited, dollars in millions) Change vs. 2023 2024 2023 GAAP Excl. F/X** U.S. Int'l (c) WW (d) U.S. Int'l (c) WW (d) U.S. Int'l (c) WW (d) U.S. Int'l (c) WW (d) Growth Portfolio Opdivo $ 1,423 $ 1,056 $ 2,479 $ 1,401 $ 986 $ 2,387 2% 7% 4% 2% 15% 7% Orencia 750 250 1,000 755 230 985 (1)% 9% 2% (1)% 15% 3% Yervoy 428 247 675 340 226 566 26% 9% 19% 26% 15% 22% Reblozyl 445 102 547 270 50 320 65% 104% 71% 65% 110% 72% Opdualag 233 21 254 186 4 190 25% >200% 34% 25% >200% 34% Breyanzi 209 54 263 85 16 101 146% >200% 160% 146% >200% 162% Camzyos 201 22 223 83 5 88 142% >200% 153% 142% >200% 153% Zeposia 115 43 158 100 33 133 15% 30% 19% 15% 33% 20% Abecma 59 46 105 56 44 100 5% 5% 5% 5% 5% 5% Sotyktu 64 19 83 56 7 63 14% 171% 32% 14% 171% 32% Krazati 36 3 39 — — — N/A N/A N/A N/A N/A N/A Augtyro 13 2 15 1 — 1 >200% N/A >200% >200% N/A >200% Cobenfy 10 — 10 — — — N/A N/A N/A N/A N/A N/A Other Growth Products (a) 186 326 512 165 160 325 13% 104% 58% 13% 106% 59% Total Growth Portfolio 4,172 2,191 6,363 3,498 1,761 5,259 19% 24% 21% 19% 31% 23% Legacy Portfolio Eliquis 2,221 974 3,195 1,872 1,002 2,874 19% (3)% 11% 19% (2)% 11% Revlimid 1,169 170 1,339 1,244 206 1,450 (6)% (17)% (8)% (6)% (15)% (7)% Pomalyst/Imnovid 685 138 823 627 263 890 9% (48)% (8)% 9% (47)% (7)% Sprycel 135 63 198 411 115 526 (67)% (45)% (62)% (67)% (41)% (61)% Abraxane 91 83 174 176 71 247 (48)% 17% (30)% (48)% 28% (26)% Other Legacy Products (b) 123 127 250 84 147 231 46% (14)% 8% 46% (15)% 7% Total Legacy Portfolio 4,424 1,555 5,979 4,414 1,804 6,218 —% (14)% (4)% —% (12)% (3)% Total Revenues $ 8,596 $ 3,746 $ 12,342 $ 7,912 $ 3,565 $ 11,477 9% 5% 8% 9% 9% 9% ** See "Use of Non-GAAP Financial Information". (a) Includes Onureg , Inrebic, Nulojix , Empliciti and royalty revenues. (b) Includes other mature brands. (c) Beginning in 2024, Puerto Rico revenues are included in International revenues. Prior period amounts have been reclassified to conform to the current presentation. (d) Worldwide (WW) includes U.S. and International (Int'l). BRISTOL-MYERS SQUIBB COMPANY PRODUCT REVENUES FOR THE TWELVE MONTHS ENDED DECEMBER 31, 2024 AND 2023 (Unaudited, dollars in millions) Change vs. 2023 2024 2023 GAAP Excl. F/X** U.S. Int'l (c) WW (d) U.S. Int'l (c) WW (d) U.S. Int'l (c) WW (d) U.S. Int'l (c) WW (d) Growth Portfolio Opdivo $ 5,350 $ 3,954 $ 9,304 $ 5,246 $ 3,763 $ 9,009 2% 5% 3% 2% 14% 7% Orencia 2,770 912 3,682 2,709 892 3,601 2% 2% 2% 2% 10% 4% Yervoy 1,599 931 2,530 1,379 859 2,238 16% 8% 13% 16% 15% 16% Reblozyl 1,444 329 1,773 804 204 1,008 80% 61% 76% 80% 65% 77% Opdualag 870 58 928 615 12 627 41% >200% 48% 41% >200% 48% Breyanzi 591 156 747 303 61 364 95% 156% 105% 95% 162% 106% Camzyos 543 59 602 225 6 231 141% >200% 161% 141% >200% 161% Zeposia 403 163 566 319 115 434 26% 42% 30% 26% 42% 30% Abecma 242 164 406 358 114 472 (32)% 44% (14)% (32)% 47% (13)% Sotyktu 190 56 246 157 13 170 21% >200% 45% 21% >200% 46% Krazati 118 8 126 — — — N/A N/A N/A N/A N/A N/A Augtyro 36 2 38 1 — 1 >200% N/A >200% >200% N/A >200% Cobenfy 10 — 10 — — — N/A N/A N/A N/A N/A N/A Other Growth Products (a) 674 931 1,605 620 591 1,211 9% 58% 33% 9% 61% 34% Total Growth Portfolio 14,840 7,723 22,563 12,736 6,630 19,366 17% 16% 17% 17% 24% 19% Legacy Portfolio Eliquis 9,631 3,702 13,333 8,482 3,724 12,206 14% (1)% 9% 14% —% 9% Revlimid 4,999 774 5,773 5,195 902 6,097 (4)% (14)% (5)% (4)% (11)% (5)% Pomalyst/Imnovid 2,695 850 3,545 2,339 1,102 3,441 15% (23)% 3% 15% (22)% 3% Sprycel 983 303 1,286 1,422 508 1,930 (31)% (40)% (33)% (31)% (36)% (32)% Abraxane 541 334 875 702 302 1,004 (23)% 11% (13)% (23)% 25% (8)% Other Legacy Products (b) 416 509 925 334 628 962 25% (19)% (4)% 25% (18)% (3)% Total Legacy Portfolio 19,265 6,472 25,737 18,474 7,166 25,640 4% (10)% —% 4% (8)% 1% Total Revenues $ 34,105 $ 14,195 $ 48,300 $ 31,210 $ 13,796 $ 45,006 9% 3% 7% 9% 8% 9% ** See "Use of Non-GAAP Financial Information". (a) Includes Onureg , Inrebic, Nulojix , Empliciti and royalty revenues. (b) Includes other mature brands. (c) Beginning in 2024, Puerto Rico revenues are included in International revenues. Prior period amounts have been reclassified to conform to the current presentation. (d) Worldwide (WW) includes U.S. and International (Int'l). BRISTOL-MYERS SQUIBB COMPANY INTERNATIONAL REVENUES (a) FOREIGN EXCHANGE IMPACT (%) (Unaudited) Three Months Ended December 31, 2024 Twelve Months Ended December 31, 2024 Revenue Change % F/X % Favorable/ (Unfavorable) ** Revenue Change % Ex- F/X ** Revenue Change % F/X % Favorable/ (Unfavorable) ** Revenue Change % Ex- F/X ** Growth Portfolio Opdivo 7% (8)% 15% 5% (9)% 14% Orencia 9% (6)% 15% 2% (8)% 10% Yervoy 9% (6)% 15% 8% (7)% 15% Reblozyl 104% (6)% 110% 61% (4)% 65% Opdualag >200% NM >200% >200% NM >200% Breyanzi >200% NM >200% 156% (6)% 162% Camzyos >200% NM >200% >200% NM >200% Zeposia 30% (3)% 33% 42% —% 42% Abecma 5% —% 5% 44% (3)% 47% Sotyktu 171% —% 171% >200% NM >200% Krazati N/A N/A N/A N/A N/A N/A Augtyro N/A N/A N/A N/A N/A N/A Cobenfy N/A N/A N/A N/A N/A N/A Other Growth Products (b) 104% (2)% 106% 58% (3)% 61% Total Growth Portfolio 24% (7)% 31% 16% (8)% 24% Legacy Portfolio Eliquis (3)% (1)% (2)% (1)% (1)% —% Revlimid (17)% (2)% (15)% (14)% (3)% (11)% Pomalyst/Imnovid (48)% (1)% (47)% (23)% (1)% (22)% Sprycel (45)% (4)% (41)% (40)% (4)% (36)% Abraxane 17% (11)% 28% 11% (14)% 25% Other Legacy Products (c) (14)% 1% (15)% (19)% (1)% (18)% Total Legacy Portfolio (14)% (2)% (12)% (10)% (2)% (8)% Total Revenues 5% (4)% 9% 3% (5)% 8% NM Not meaningful ** See "Use of Non-GAAP Financial Information". (a) Beginning in 2024, Puerto Rico revenues are included in International revenues. Prior period amounts have been reclassified to conform to the current presentation. (b) Includes Onureg , Nulojix , Empliciti and royalty revenues. (c) Includes other mature brands. BRISTOL-MYERS SQUIBB COMPANY WORLDWIDE REVENUES (a) FOREIGN EXCHANGE IMPACT (%) (Unaudited) Three Months Ended December 31, 2024 Twelve Months Ended December 31, 2024 Revenue Change % F/X % Favorable/ (Unfavorable) ** Revenue Change % Ex- F/X ** Revenue Change % F/X % Favorable/ (Unfavorable) ** Revenue Change % Ex- F/X ** Growth Portfolio Opdivo 4% (3)% 7% 3% (4)% 7% Orencia 2% (1)% 3% 2% (2)% 4% Yervoy 19% (3)% 22% 13% (3)% 16% Reblozyl 71% (1)% 72% 76% (1)% 77% Opdualag 34% —% 34% 48% —% 48% Breyanzi 160% (2)% 162% 105% (1)% 106% Camzyos 153% —% 153% 161% —% 161% Zeposia 19% (1)% 20% 30% —% 30% Abecma 5% —% 5% (14)% (1)% (13)% Sotyktu 32% —% 32% 45% (1)% 46% Krazati N/A N/A N/A N/A N/A N/A Augtyro >200% NM >200% >200% NM >200% Cobenfy N/A N/A N/A N/A N/A N/A Other Growth Products (b) 58% (1)% 59% 33% (1)% 34% Total Growth Portfolio 21% (2)% 23% 17% (2)% 19% Legacy Portfolio Eliquis 11% —% 11% 9% —% 9% Revlimid (8)% (1)% (7)% (5)% —% (5)% Pomalyst/Imnovid (8)% (1)% (7)% 3% —% 3% Sprycel (62)% (1)% (61)% (33)% (1)% (32)% Abraxane (30)% (4)% (26)% (13)% (5)% (8)% Other Legacy Products (c) 8% 1% 7% (4)% (1)% (3)% Total Legacy Portfolio (4)% (1)% (3)% —% (1)% 1% Total Revenues 8% (1)% 9% 7% (2)% 9% NM Not meaningful ** See "Use of Non-GAAP Financial Information". (a) Worldwide (WW) includes U.S. and International (Int'l). (b) Includes Onureg , Nulojix , Empliciti and royalty revenues. (c) Includes other mature brands. BRISTOL-MYERS SQUIBB COMPANY RECONCILIATION OF GAAP AND NON-GAAP GROWTH DOLLARS AND PERCENTAGES EXCLUDING FOREIGN EXCHANGE IMPACT * (Unaudited, dollars in millions) THREE MONTHS 2024 2023 Change $ Change % Favorable / (Unfavorable) F/X $ ** 2024 Excl. F/X ** Favorable / (Unfavorable) F/X % ** % Change Excl. F/X ** Revenues $ 12,342 $ 11,477 $ 865 8 % $ (142) $ 12,484 (1)% 9% Gross profit 7,530 8,732 (1,202 ) (14 )% N/A N/A N/A N/A Gross profit excluding specified items (a) 9,130 8,770 360 4 % N/A N/A N/A N/A Gross margin (b) 61.0 % 76.1 % Gross margin excluding specified items 74.0 % 76.4 % Marketing, selling and administrative 2,136 2,073 63 3 % 21 2,157 1% 4% Marketing, selling and administrative excluding specified items (a) 2,105 2,064 41 2 % 21 2,126 1% 3% Research and development 3,191 2,478 713 29 % 8 3,199 —% 29% Research and development excluding specified items (a) 2,788 2,476 312 13 % 8 2,796 —% 13% Operating margin (c) 17.8 % 36.4 % Operating margin excluding specified items 34.3 % 36.9 % TWELVE MONTHS 2024 2023 Change $ Change % Favorable / (Unfavorable) F/X $ ** 2024 Excl. F/X ** Favorable / (Unfavorable) F/X % ** % Change Excl. F/X ** Revenues $ 48,300 $ 45,006 $ 3,294 7 % $ (654) $ 48,954 (2)% 9% Gross profit 34,332 34,313 19 — % N/A N/A N/A N/A Gross profit excluding specified items (a) 36,351 34,488 1,863 5 % N/A N/A N/A N/A Gross margin (b) 71.1 % 76.2 % Gross margin excluding specified items 75.3 % 76.6 % Marketing, selling and administrative 8,414 7,772 642 8 % 89 8,503 1% 9% Marketing, selling and administrative excluding specified items (a) 7,992 7,678 314 4 % 89 8,081 1% 5% Research and development 11,159 9,299 1,860 20 % 40 11,199 —% 20% Research and development excluding specified items (a) 9,782 9,112 670 7 % 40 9,822 1% 8% Operating margin (c) 30.6 % 38.3 % Operating margin excluding specified items 38.5 % 39.3 % * Foreign exchange impacts were derived 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. ** See "Use of Non-GAAP Financial Information". (a) Refer to the Specified Items schedule below for further details. (b) Represents gross profit as a percentage of Revenues. (c) Operating margin represents gross profit less marketing, selling and administrative expenses and research and development expenses, as a percentage of Revenues. BRISTOL-MYERS SQUIBB COMPANY SPECIFIED ITEMS (Unaudited, dollars in millions) Three Months Ended December 31, Twelve Months Ended December 31, 2024 2023 2024 2023 Inventory purchase price accounting adjustments $ 13 $ — $ 47 $ 84 Intangible asset impairment 1,559 27 1,839 27 Site exit and other costs 28 11 133 64 Cost of products sold 1,600 38 2,019 175 Acquisition related charges (a) — — 372 — Site exit and other costs 31 9 50 94 Marketing, selling and administrative 31 9 422 94 IPRD impairments 390 — 980 80 Priority review voucher — — — 95 Acquisition related charges (a) — — 348 — Site exit and other costs 13 2 49 12 Research and development 403 2 1,377 187 Amortization of acquired intangible assets 1,693 2,278 8,872 9,047 Interest expense (b) (12 ) (13 ) (49 ) (52 ) Equity investment (gain)/losses 204 (54 ) (18 ) 152 Acquisition expenses — 32 50 32 Integration expenses 70 62 284 242 Divestiture losses 10 — 15 — Litigation and other settlements — — 61 (397 ) Provision for restructuring 77 44 635 365 Intangible asset impairment — — 47 29 Other 9 — 120 (6 ) Other (income)/expense, net 358 71 1,145 365 Increase to Earnings before income taxes 4,085 2,398 13,835 9,868 Income taxes on items above (749 ) (695 ) (2,045 ) (1,639 ) Income tax reserve releases — — (502 ) — Income taxes attributed to a non-U.S. tax ruling — — — (656 ) Income taxes (749 ) (695 ) (2,547 ) (2,295 ) Increase to net earnings $ 3,336 $ 1,703 $ 11,288 $ 7,573 (a) Includes cash settlement of unvested stock awards, and other related costs incurred in connection with the recent acquisitions of Karuna, RayzeBio and Mirati. (b) Includes amortization of purchase price adjustments to Celgene debt. BRISTOL-MYERS SQUIBB COMPANY RECONCILIATION OF CERTAIN GAAP LINE ITEMS TO CERTAIN NON-GAAP LINE ITEMS (Unaudited, dollars and shares in millions except per share data) Three Months Ended December 31, 2024 Twelve Months Ended December 31, 2024 GAAP Specified Items (a) Non-GAAP GAAP Specified Items (a) Non-GAAP Gross profit $ 7,530 $ 1,600 $ 9,130 $ 34,332 $ 2,019 $ 36,351 Marketing, selling and administrative 2,136 (31 ) 2,105 8,414 (422 ) 7,992 Research and development 3,191 (403 ) 2,788 11,159 (1,377 ) 9,782 Amortization of acquired intangible assets 1,693 (1,693 ) — 8,872 (8,872 ) — Other (income)/expense, net 305 (358 ) (53 ) 893 (1,145 ) (252 ) Earnings/(Loss) before income taxes 175 4,085 4,260 (8,379 ) 13,835 5,456 Provision for income taxes 99 749 848 554 2,547 3,101 Net earnings/(loss) attributable to BMS used for diluted EPS calculation $ 72 $ 3,336 $ 3,408 $ (8,948 ) $ 11,288 $ 2,340 Weighted-average common shares outstanding—diluted 2,037 2,037 2,037 2,027 2,032 2,032 Diluted earnings/(loss) per share $ 0.04 $ 1.63 $ 1.67 $ (4.41 ) $ 5.56 $ 1.15 Effective tax rate 56.6 % (36.7 )% 19.9 % (6.6 )% 63.4 % 56.8 % Three Months Ended December 31, 2023 Twelve Months Ended December 31, 2023 GAAP Specified Items (a) Non-GAAP GAAP Specified Items (a) Non-GAAP Gross profit $ 8,732 $ 38 $ 8,770 $ 34,313 $ 175 $ 34,488 Marketing, selling and administrative 2,073 (9 ) 2,064 7,772 (94 ) 7,678 Research and development 2,478 (2 ) 2,476 9,299 (187 ) 9,112 Amortization of acquired intangible assets 2,278 (2,278 ) — 9,047 (9,047 ) — Other (income)/expense, net (371 ) (71 ) (442 ) (1,158 ) (365 ) (1,523 ) Earnings before income taxes 1,674 2,398 4,072 8,440 9,868 18,308 Provision for income taxes (88 ) 695 607 400 2,295 2,695 Net earnings attributable to BMS used for diluted EPS calculation $ 1,762 $ 1,703 $ 3,465 $ 8,025 $ 7,573 $ 15,598 Weighted-average common shares outstanding—diluted 2,033 2,033 2,033 2,078 2,078 2,078 Diluted earnings per share $ 0.87 $ 0.83 $ 1.70 $ 3.86 $ 3.65 $ 7.51 Effective tax rate (5.3 )% 20.2 % 14.9 % 4.7 % 10.0 % 14.7 % (a) Refer to the Specified Items schedule above for further details. Effective tax rate on the Specified Items represents the difference between the GAAP and Non-GAAP effective tax rate. BRISTOL-MYERS SQUIBB COMPANY NET DEBT CALCULATION AS OF DECEMBER 31, 2024 AND DECEMBER 31, 2023 (Unaudited, dollars in millions) December 31, 2024 December 31, 2023 Cash and cash equivalents $ 10,346 $ 11,464 Marketable debt securities - current 513 816 Marketable debt securities - non-current 320 364 Cash, cash equivalents and marketable debt securities $ 11,179 $ 12,644 Short-term debt obligations (2,046 ) (3,119 ) Long-term debt (47,603 ) (36,653 ) Net debt position $ (38,470 ) $ (27,128 )

– KOMET-001 registrational trial in R/R NPM1-m AML achieved primary CR/CRh endpoint; topline data submitted for presentation at an upcoming medical meeting – – NDA submission for ziftomenib on track for 2Q 2025 – – Registrational KOMET-017-IC trial of intensive chemotherapy combination will assess MRD negative CR and EFS as dual-primary endpoints to support potential U.S. accelerated approval and full approval – – Registrational KOMET-017-NIC trial of venetoclax / azacitidine combination will assess CR and OS as dual-primary endpoints to support potential U.S. accelerated approval and full approval – – KOMET-017-IC and NIC Phase 3 trials expected to initiate in 2H 2025 – – Multiple clinical data presentations for ziftomenib and pipeline programs anticipated throughout 2025 – – Kura management to host virtual investor event today at 4:30 p.m. ET – SAN DIEGO , Feb. 05, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA, “Kura”) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced positive topline results from KOMET-001, the Phase 2 registration-directed trial of ziftomenib, a highly selective, once-daily, oral investigational menin inhibitor, in patients with relapsed/refractory (R/R) NPM1-mutant (NPM1-m) acute myeloid leukemia (AML). Topline data for KOMET-001 has been submitted for presentation at an upcoming medical conference in the second quarter of 2025, and Kura is on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ziftomenib in the second quarter of 2025. The companies, which announced their joint collaboration to commercialize ziftomenib in 2024, also announced they plan to initiate a single protocol containing two independently powered, randomized, double-blind, placebo-controlled, registrational Phase 3 trials to evaluate ziftomenib in combination with both intensive and non-intensive combination regimens in patients with newly diagnosed NPM1-m and KMT2A-rearranged (KMT2A-r) AML, following successful interactions with the FDA. Each frontline trial design includes dual-primary endpoints to support potential U.S. accelerated approval and full approval. The companies plan to initiate the two frontline Phase 3 trials in the second half of 2025 and anticipate multiple clinical data presentations for the ziftomenib AML program as well as Kura’s pipeline programs in 2025. “We are excited to report positive topline results in R/R NPM1-m AML patients, underscoring the strong foundation for our ziftomenib program to potentially transform the treatment landscape for these patients. We appreciate the commitment and dedication from our team as well as our partners at Kyowa Kirin,” said Troy Wilson , Ph.D., J.D., President and Chief Executive Officer of Kura Oncology . “We believe this achievement for our KOMET-001 trial positions Kura and Kyowa Kirin to deliver on its path to commercialization of ziftomenib, beginning with our potential first NDA submission in R/R NPM1-m AML next quarter. Furthermore, we believe the positive FDA interactions for the KOMET-017 protocol, including the opportunity for accelerated approval in both trials, pave the way for us to position ziftomenib as a potential frontline therapy to address up to 50% of patients with AML.” Positive KOMET-001 Ziftomenib Monotherapy Trial in R/R NPM1-m AML Kura and Kyowa Kirin today announced positive topline results from KOMET-001, a Phase 2 registration-directed trial of ziftomenib, in patients with R/R NPM1-m AML. The KOMET-001 trial achieved its primary endpoint of CR plus CR with partial hematological recovery (CRh) and the primary endpoint was statistically significant. The benefit-risk profile for ziftomenib is highly encouraging, and safety and tolerability were consistent with previous reports. The KOMET-001 registration-directed trial is designed to assess evidence of clinical activity, safety and tolerability of ziftomenib, the only investigational therapy to receive Breakthrough Therapy Designation (BTD) from the FDA for treatment of R/R NPM1-mutant AML. Full results from the KOMET-001 trial will be presented at a future medical meeting in the second quarter of 2025. After successful FDA interactions in part facilitated by BTD, Kura announced that it is on track to submit an NDA to the FDA for ziftomenib for the treatment of patients with R/R NPM1-mutant AML in the second quarter of 2025. Positive FDA Feedback for Upcoming Frontline Combination Trial Designs Kura and Kyowa Kirin recently announced plans for KOMET-017, a global protocol evaluating ziftomenib in combination with standards of care for adults with newly diagnosed NPM1-m or KMT2A-r AML. Following successful End-of-Phase 1 meetings with the FDA, the companies announced they will proceed with plans to initiate the KOMET-017 trial, comprising of two independent, global, randomized, double-blind, placebo-controlled Phase 3 trials to evaluate ziftomenib in combination with both intensive and non-intensive combination regimens in patients with newly diagnosed NPM1-m and/or KMT2A-r AML. The positive feedback from the FDA, along with data from the KOMET-007 trial presented at the 2024 American Society of Hematology Annual Meeting, reinforces Kura’s and Kyowa Kirin’s commitment to evaluating ziftomenib in patients across the continuum of frontline treatment options. The registrational KOMET-017-IC (Intensive Combination) trial will evaluate the combination of ziftomenib with induction chemotherapy (7+3) in newly diagnosed NPM1-m and KMT2A-r AML patients. Patients will be randomized to receive ziftomenib or placebo, in combination with standard induction, consolidation chemotherapy and post consolidation maintenance. The KOMET-017-IC trial will assess minimum residual disease (MRD) negative complete response (CR) and event-free survival (EFS) as dual-primary endpoints to support potential U.S. accelerated approval and full approval, respectively and is anticipated to be initiated in the second half of 2025. The registrational KOMET-017-NIC (Non-Intensive Combination) trial will evaluate the combination of ziftomenib with venetoclax plus azacitidine in newly diagnosed NPM1-m patients unfit to receive intensive chemotherapy. The KOMET-017-NIC trial will assess CR and overall survival (OS) as dual-primary endpoints to support potential U.S. accelerated approval and full approval, respectively. Patients will be randomized to receive ziftomenib or placebo, in combination with venetoclax and azacitidine. The KOMET-017-NIC trial is anticipated to be initiated in the second half of 2025. “Even with approved therapies, up to 70% of patients who achieve a first CR will see their AML return within 3 years. The 5-year survival rate for AML is 31.9% and as low as 11.2% for patients aged older than 65 years,” said Mollie Leoni , M.D., Chief Medical Officer of Kura Oncology . “Given this urgent need, we are pleased with the outcome of these FDA interactions and look forward to initiating our Phase 3 trials to establish the benefit-risk profile of ziftomenib in both the intensive and non-intensive chemotherapy settings. We were particularly pleased by the FDA’s willingness to allow the trials to use MRD negative CR and CR as primary endpoints for accelerated approval in the two populations. In so doing, the KOMET-017 protocol is breaking new ground, which may help deliver ziftomenib more quickly to patients living with this devastating disease.” “Starting patients on combination therapy early is essential to improving outcomes in AML,” said Takeyoshi Yamashita , Ph.D., Senior Managing Executive Officer and Chief Medical Officer of Kyowa Kirin . “The data from the completed KOMET-001 trial and FDA feedback on the planned KOMET-017 protocol strengthens our confidence these trials may offer valuable treatment options for patients throughout the continuum of treatment. We remain committed to working with our colleagues at Kura to bring ziftomenib as rapidly as possible to AML patients worldwide.” MRD is a term describing small numbers of leukemic cells, which are still detectable during or after treatment, even when a patient has achieved CR by standard criteria. Remaining leukemia cells in the body can become active and start to multiply, resulting in a relapse of the disease, which may be fatal for patients. Achieving MRD negativity, which may be associated with longer remissions and improved survival, means that a treatment has reduced the number of leukemic cells to below the limit of detection by the most sensitive analytical methods. “We carefully designed KOMET-017 to allow patients to go on the same protocol but on one of the two sub-studies based on whether they are fit or unfit for intensive chemotherapy, and this approach is intended to be very patient centric, facilitate rapid enrollment and offer operational advantages to the study sites,” said Amer Zeidan , MBBS, MHS, chief of the Division of Hematologic Malignancies , director of Hematology Early Therapeutics Research at Yale Cancer Center , and the lead investigator of the KOMET-017 trial. “Further, we designed KOMET-017 to allow for a potential accelerated approval based on endpoints that have been widely accepted as surrogates for meaningful clinical benefit in these patient populations,” Dr Zeidan added. “The association between MRD negativity and improved survival in patients with NPM1-mutated AML is well established in the literature. AML experts around the world recommend monitoring MRD in patients to guide treatment decisions. The best opportunity to achieve long-lasting remission and extend survival is to achieve MRD negativity with the first attempt at treatment. Therefore, using MRD negative CR as an approvable endpoint in AML is very innovative and could allow faster availability of therapies to our patients,” Dr Zeidan concluded. 2025 Anticipated Clinical Data Highlights Kura and Kyowa Kirin expect to present multiple clinical data updates from their ziftomenib AML program, and Kura expects to present updates from its KO-2806 and tipifarnib programs, in 2025 as follows: Topline data from the KOMET-001 trial of ziftomenib monotherapy in R/R NPM1-m AML (2Q 2025) KOMET-007 Phase 1b data of ziftomenib in combination with 7+3 in newly diagnosed NPM1-m AML and KMT2A-r AML (2Q 2025) FIT-001 Phase 1 data of KO-2806 monotherapy in HRAS-mutant and KRAS-mutated solid tumors (2H 2025) FIT-001 Phase 1 data of KO-2806 in combination with cabozantinib in renal cell carcinoma (RCC) (2H 2025) KURRENT-HN Phase 1 data of tipifarnib in combination with alpelisib in PIK3CA-dependent head and neck squamous cell carcinoma (HNSCC) (2H 2025) KOMET-007 Phase 1b data of ziftomenib in combination with venetoclax / azacitidine in NPM1-m AML (2H 2025) Virtual Investor Event Kura will host a webcast and conference call featuring company management today at 4:30 p.m. ET . Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors section of Kura’s website, with an archived replay available shortly after the event. About AML AML primarily affects adults and is one of the most difficult-to-treat blood cancers. AML starts in the bone marrow and can quickly move to the blood and other parts of the body including the lymph nodes, spleen and central nervous system. Approximately 20,000 Americans are diagnosed with AML each year, with an NPM1 genetic mutation or KMT2A rearrangement found in approximately 35% of cases. Relapse in AML is common, and despite available treatments, nearly 11,000 Americans will die from the disease each year. About Ziftomenib Ziftomenib is a selective and oral menin inhibitor currently in development for the treatment of genetically defined AML patients with high unmet need. In April 2024, ziftomenib received BTD by the FDA for the treatment of R/R NPM1-mutant AML based on data from Kura’s KOMET-001 clinical trial. Additional information about clinical trials for ziftomenib can be found at kuraoncology.com/clinical-trials/#ziftomenib. About Kura Oncology Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline consists of small molecule drug candidates that target cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive BTD from the FDA for the treatment of relapsed/refractory (R/R) NPM1-m AML. In November 2024 , Kura entered a global strategic collaboration agreement with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML has been completed, and the companies anticipate submission of a New Drug Application in the second quarter of 2025. Kura and Kyowa Kirin are also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-mutant and KMT2A-rearranged AML. KO-2806, a next-generation farnesyl transferase inhibitor, is being evaluated in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies. Tipifarnib, a potent and selective FTI, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma. For additional information, please visit Kura’s website at https://kuraoncology.com/ and follow us on X and LinkedIn. About Kyowa Kirin Kyowa Kirin aims to discover and deliver novel medicines and treatments with life-changing value. As a Japan -based Global Specialty Pharmaceutical Company , Kyowa Kirin has invested in drug discovery and biotechnology innovation for more than 70 years and is currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients with high unmet medical needs, such as bone & mineral, intractable hematological diseases/hemato-oncology and rare diseases. A shared commitment to Kyowa Kirin’s values, to sustainable growth, and to making people smile unites Kyowa Kirin across the globe. You can learn more about the business of Kyowa Kirin at www.kyowakirin.com. Forward-Looking Statements This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the therapeutic potential and potential success of ziftomenib, KO-2806 and tipifarnib; plans, trial designs and expected timing of clinical trials; the expected timing and presentation of data from clinical trials; the anticipated timing of submission of a New Drug Application for ziftomenib; the potential for U.S. accelerated approval and full approval of product candidates; and the success and impact of interactions with the FDA. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings, applications and other interactions with regulatory bodies, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties that Kura faces, please refer to Kura’s periodic and other filings with the Securities and Exchange Commission , which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Amer Zeidan has consulted for and received honoraria from Kura. Opinions expressed are his own and do not necessarily represent those of his employer. Kura Contacts Investors: Patti Bank Managing Director(415) 513-1284patti.bank@icrhealthcare.com Media: Alexandra Weingarten Associate Director, Corporate Communications & Investor Relations(858) 500-8822alexandra@kuraoncology.com Kyowa Kirin Contacts Wataru Suzuki Corporate Communications Department – Globalmedia@kyowakirin.com Lisa Popyk Senior Director, Corporate Communications – Kyowa Kirin North America lisa.popyk.3z@kyowakirin.com Source: Kura Oncology, Inc.