Luspatercept-AAMT

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 )

RAHWAY, N.J.--( BUSINESS WIRE )--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the fourth quarter of 2024. “ We delivered strong growth in 2024, reflecting demand for our innovative portfolio, including for KEYTRUDA, which continues to benefit more patients with cancer globally, the successful launch of WINREVAIR and strong performance of our Animal Health business,” said Robert M. Davis, chairman and chief executive officer, Merck. " We’re continuing to progress our pipeline, advance key clinical programs and augment our pipeline through promising business development. Our business remains well positioned thanks to the dedication of our talented global team, and I am more confident than ever in our long-term growth potential.” Financial Summary $ in millions, except EPS amounts Fourth Quarter Year Ended 2024 2023 Change Change Ex-Exchange Dec. 31, 2024 Dec. 31, 2023 Change Change Ex-Exchange Sales $15,624 $14,630 7% 9% $64,168 $60,115 7% 10% GAAP net income (loss) 1 3,743 (1,226) N/M N/M 17,117 365 N/M N/M Non-GAAP net income that excludes certain items 1,2* 4,372 66 N/M N/M 19,444 3,837 N/M N/M GAAP EPS 1.48 (0.48) N/M N/M 6.74 0.14 N/M N/M Non-GAAP EPS that excludes certain items 2* 1.72 0.03 N/M N/M 7.65 1.51 N/M N/M *Refer to table on page 9. N/M - not meaningful Generally Accepted Accounting Principles (GAAP) earnings per share (EPS) assuming dilution was $1.48 for the fourth quarter and $6.74 for the full year of 2024. Non-GAAP EPS was $1.72 for the fourth quarter and $7.65 for the full year of 2024. GAAP and non-GAAP EPS in the fourth quarter of 2024 include a charge of $0.23 per share related to the execution of licensing agreements with LaNova Medicines Ltd. (LaNova) and Hansoh Pharma (Hansoh). GAAP loss per share and non-GAAP EPS in the fourth quarter of 2023 include a charge of $1.69 per share related to a collaboration with Daiichi Sankyo. GAAP and non-GAAP EPS for the full years of 2024 and 2023 include charges of $1.28 and $6.21 per share, respectively, related to certain collaborations, licensing agreements and asset acquisitions. Non-GAAP EPS excludes acquisition- and divestiture-related costs, costs related to restructuring programs, and income and losses from investments in equity securities. Non-GAAP EPS in the fourth quarter and full year of 2024 also exclude a benefit due to a reduction in reserves for unrecognized income tax benefits resulting from the expiration of the statute of limitations for assessments related to certain federal tax return years. Non-GAAP EPS for the full year of 2023 also excludes a charge related to settlements with certain plaintiffs in the Zetia antitrust litigation. Fourth-Quarter Sales Performance The following table reflects sales of the company’s top products and significant performance drivers. Fourth Quarter $ in millions 2024 2023 Change Change Ex-Exchange Commentary Total Sales $15,624 $14,630 7% 9% The negative impact of foreign exchange was primarily due to devaluation of Argentine peso, which was largely offset by inflation-related price increases, consistent with practice in that market. Pharmaceutical 14,042 13,141 7% 8% Increase driven by growth in oncology and cardiovascular, partially offset by declines in diabetes, vaccines, immunology and virology. KEYTRUDA 7,836 6,608 19% 21% Growth driven by continued strong global demand from metastatic indications, including increased uptake in bladder and endometrial cancers, as well as increased global uptake in earlier-stage indications, including triple-negative breast cancer and non-small cell lung cancer (NSCLC). The negative impact of foreign exchange was primarily due to devaluation of Argentine peso, which was largely offset by inflation-related price increases. GARDASIL/GARDASIL 9 1,550 1,871 -17% -18% Decline primarily due to lower demand in China, partially offset by higher demand in most international regions, particularly in Japan. PROQUAD, M-M-R II and VARIVAX 594 545 9% 9% Growth primarily due to higher pricing in the U.S. and higher tenders in certain international markets, partially offset by lower demand in the U.S. JANUVIA/JANUMET 487 787 -38% -36% Decline primarily due to lower pricing in the U.S., as well as ongoing generic competition in many international markets and supply constraints in China. BRIDION 449 429 5% 5% Growth primarily due to higher demand in the U.S., partially offset by generic competition in certain international markets, particularly in Japan and Europe. Lynparza* 365 315 16% 18% Growth primarily due to higher global demand. Lenvima* 255 226 13% 14% Growth primarily due to timing of shipments in certain international markets. PREVYMIS 215 175 23% 23% Growth primarily due to higher demand in most markets, particularly in the U.S. WINREVAIR 200 - - - Represents continued uptake since second-quarter launch in the U.S. VAXNEUVANCE 161 176 -9% -9% Decline primarily driven by lower demand in the U.S. due to competition, partially offset by continued uptake from launches in Europe and the Asia Pacific region. WELIREG 160 72 122% 123% Growth primarily driven by higher demand in the U.S., largely attributable to ongoing uptake of a new indication. SIMPONI - 171 N/M N/M Marketing rights in former Merck territories reverted to Johnson & Johnson on Oct. 1, 2024. Animal Health 1,397 1,278 9% 13% Growth primarily driven by higher pricing for both Livestock and Companion Animal product portfolios, as well as sales related to July 2024 acquisition of Elanco aqua business and higher demand for Livestock products. Approximately 3 percentage points of the negative impact of foreign exchange were due to devaluation of Argentine peso, which were largely offset by inflation-related price increases. Livestock 889 808 10% 14% Growth primarily driven by higher demand for poultry products, sales related to acquisition of Elanco aqua business, as well as higher pricing across the portfolio. Companion Animal 508 470 8% 10% Growth primarily driven by higher pricing across the product portfolio. Sales of BRAVECTO were $209 million and $197 million in current and prior year quarters, respectively, which represented growth of 6%, or 10% excluding impact of foreign exchange. Other Revenues** 185 211 -13% 3% Decline primarily due to impact of revenue-hedging activities and lower revenues from third-party manufacturing arrangements, partially offset by payments received for out-licensing arrangements and higher royalty income. *Alliance revenue for this product represents Merck’s share of profits, which are product sales net of cost of sales and commercialization costs. **Other revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities. N/M – not meaningful Full-Year Sales Performance The following table reflects sales of the company’s top products and significant performance drivers. Year Ended $ in millions Dec. 31, 2024 Dec. 31, 2023 Change Change Ex- Exchange Total Sales $64,168 $60,115 7% 10% Pharmaceutical 57,400 53,583 7% 10% KEYTRUDA 29,482 25,011 18% 22% GARDASIL/GARDASIL 9 8,583 8,886 -3% -2% PROQUAD, M-M-R II and VARIVAX 2,485 2,368 5% 5% JANUVIA/JANUMET 2,268 3,366 -33% -29% BRIDION 1,764 1,842 -4% -3% Lynparza* 1,311 1,199 9% 11% Lenvima* 1,010 960 5% 6% LAGEVRIO 964 1,428 -33% -28% VAXNEUVANCE 808 665 22% 23% PREVYMIS 785 605 30% 33% ROTATEQ 711 769 -8% -7% SIMPONI** 543 710 -24% -23% WELIREG 509 218 133% 133% WINREVAIR 419 - - - Animal Health 5,877 5,625 4% 8% Livestock 3,462 3,337 4% 9% Companion Animal 2,415 2,288 6% 7% Other Revenues*** 891 907 -2% 4% *Alliance revenue for this product represents Merck’s share of profits, which are product sales net of cost of sales and commercialization costs. **Marketing rights in former Merck territories reverted to Johnson & Johnson on Oct. 1, 2024. ***Other revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities. Full-year 2024 pharmaceutical sales grew 7% to $57.4 billion. Excluding the unfavorable impact of foreign exchange, pharmaceutical sales grew 10%. Approximately 2 percentage points of the negative impact of foreign exchange were due to devaluation of the Argentine peso, which were largely offset by inflation-related price increases, consistent with practice in that market. Pharmaceutical sales growth was primarily driven by higher sales in oncology, particularly KEYTRUDA and WELIREG, as well as increased alliance revenue from Reblozyl and Lynparza. Higher sales in the cardiovascular franchise, reflecting the successful launch of WINREVAIR, as well as higher sales of certain hospital acute care products, particularly PREVYMIS, also drove revenue growth in 2024. Pharmaceutical sales growth in 2024 was partially offset by lower sales of JANUVIA and JANUMET, primarily reflecting lower pricing in the U.S. and generic competition in many international markets, lower sales of the COVID-19 medication LAGEVRIO, lower sales of GARDASIL/GARDASIL 9 and lower sales of SIMPONI and REMICADE, reflecting the transfer of marketing rights in former Merck territories back to Johnson & Johnson. Full-year 2024 Animal Health sales grew 4% to $5.9 billion. Excluding the unfavorable impact of foreign exchange, Animal Health sales grew 8%. Approximately 2 percentage points of the negative impact of foreign exchange were due to devaluation of the Argentine peso, which were largely offset by inflation-related price increases, consistent with practice in that market. Full-year sales growth was primarily driven by higher pricing across both the Companion Animal and Livestock product portfolios, and higher demand for poultry and swine products, as well as sales related to the acquisition of the Elanco aqua business. Sales of BRAVECTO were $1.1 billion in 2024, which represented growth of 6%, or 8% excluding the impact of foreign exchange. Fourth-Quarter and Full-Year Expense, EPS and Related Information The table below presents selected expense information. $ in millions GAAP Acquisition- and Divestiture- Related Costs 3 Restructuring Costs (Income) Loss From Investments in Equity Securities Non- GAAP 2 Fourth Quarter 2024 Cost of sales $3,828 $701 $121 $- $3,006 Selling, general and administrative 2,864 29 16 - 2,819 Research and development 4,585 12 (1) - 4,574 Restructuring costs 51 - 51 - - Other (income) expense, net 126 (31) - 152 5 Fourth Quarter 2023 Cost of sales $3,911 $454 $117 $- $3,340 Selling, general and administrative 2,804 24 29 - 2,751 Research and development 9,628 790 - - 8,838 Restructuring costs 255 - 255 - - Other (income) expense, net 78 (35) - (61) 174 $ in millions GAAP Acquisition- and Divestiture- Related Costs 3 Restructuring Costs (Income) Loss From Investments in Equity Securities Certain Other Items Non- GAAP 2 Year Ended December 31, 2024 Cost of sales $15,193 $2,409 $495 $- $ - $12,289 Selling, general and administrative 10,816 117 83 - - 10,616 Research and development 17,938 72 1 - - 17,865 Restructuring costs 309 - 309 - - - Other (income) expense, net (24) (79) - 45 - 10 Year Ended December 31, 2023 Cost of sales $16,126 $2,018 $211 $- $- $13,897 Selling, general and administrative 10,504 86 122 - - 10,296 Research and development 30,531 819 1 - - 29,711 Restructuring costs 599 - 599 - - - Other (income) expense, net 466 (47) - (279) 573 219 GAAP Expense, EPS and Related Information Gross margin was 75.5% for the fourth quarter of 2024 compared with 73.3% for the fourth quarter of 2023. The increase was primarily due to the favorable effects of product mix (including lower royalty rates related to KEYTRUDA and GARDASIL/GARDASIL 9) and foreign exchange, partially offset by higher manufacturing-related costs (including inventory write-offs) and higher amortization of intangible assets. Gross margin was 76.3% for the full year of 2024 compared with 73.2% for the full year of 2023. The increase was primarily due to the favorable effects of product mix (including lower royalty rates related to KEYTRUDA and GARDASIL/GARDASIL 9) and foreign exchange, partially offset by higher amortization of intangible assets, as well as higher restructuring costs (primarily reflecting asset impairment charges) and higher manufacturing-related costs (including inventory write-offs). Selling, general and administrative (SG&A) expenses were $2.9 billion in the fourth quarter of 2024, an increase of 2% compared with the fourth quarter of 2023. The increase was primarily due to higher promotional and selling costs, partially offset by the favorable impact of foreign exchange and lower restructuring costs. Full-year 2024 SG&A expenses were $10.8 billion, an increase of 3% compared with full-year 2023. The increase was primarily due to higher administrative, promotional, selling and acquisition-related costs, partially offset by the favorable impact of foreign exchange and lower restructuring costs. Research and development (R&D) expenses were $4.6 billion in the fourth quarter of 2024, a decrease of 52% compared with the fourth quarter of 2023. R&D expenses were $17.9 billion for the full year of 2024, a decrease of 41% compared with the full year of 2023. The declines in both the fourth quarter and full year of 2024 were primarily due to lower charges for business development activity, lower intangible asset impairment charges, and the favorable impact of foreign exchange, partially offset by increased compensation and benefit costs and higher clinical development spending. Other (income) expense, net, was $126 million of expense in the fourth quarter of 2024 compared with $78 million of expense in the fourth quarter of 2023. The unfavorability was primarily due to net losses from investments in equity securities compared with net income from investments in equity securities in the prior year quarter, partially offset by lower foreign exchange losses and lower net interest expense. Other (income) expense, net, was $24 million of income in the full year of 2024 compared with $466 million of expense in the full year of 2023, primarily due to a $572.5 million charge in 2023 related to settlements with certain plaintiffs in the Zetia antitrust litigation. The favorability was also due to $170 million of income related to the expansion of an existing development and commercialization agreement with Daiichi Sankyo, as well as lower foreign exchange losses in 2024. Other (income) expense, net, in the full year of 2024 was unfavorably affected by lower net income from investments in equity securities and higher net interest expense compared with 2023. The effective tax rates of 10.2% and 14.1% for the fourth quarter and full year of 2024, respectively, include a 6.2 percentage point favorable impact and a 2.6 percentage point favorable impact, respectively, due to a reduction in reserves for unrecognized income tax benefits, resulting from the expiration of the statute of limitations for assessments related to certain federal tax return years. GAAP EPS was $1.48 for the fourth quarter of 2024 compared with a loss per share of $0.48 for the fourth quarter of 2023, primarily driven by lower charges for business development transactions, operational strength in the business, lower intangible asset impairment charges, and a benefit from the expiration of the statute of limitations for assessments related to the 2020 federal tax return year. GAAP EPS was $6.74 for the full year of 2024 compared with EPS of $0.14 for the full year of 2023. The increase was primarily driven by lower charges for business development transactions, operational strength in the business, lower intangible asset impairment charges, a benefit from the expiration of the statute of limitations for the 2020 and 2019 federal tax return years, and a charge in the prior year for settlements with certain plaintiffs in the Zetia antitrust litigation, partially offset by the unfavorable effect of foreign exchange. Non-GAAP Expense, EPS and Related Information Non-GAAP gross margin was 80.8% for the fourth quarter of 2024 compared with 77.2% for the fourth quarter of 2023. Non-GAAP gross margin was 80.8% for the full year of 2024 compared with 76.9% for the full year of 2023. The non-GAAP gross margin improvements in both the fourth quarter and full year of 2024 were primarily due to the favorable effects of product mix (including lower royalty rates related to KEYTRUDA and GARDASIL/GARDASIL 9) and foreign exchange, partially offset by higher manufacturing-related costs (including inventory write-offs). Non-GAAP SG&A expenses were $2.8 billion in the fourth quarter of 2024, an increase of 2% compared with the fourth quarter of 2023. Non-GAAP SG&A expenses were $10.6 billion for the full year of 2024, an increase of 3% compared with the full year of 2023. The increases were primarily due to higher promotional and selling costs and, for the full year, higher administrative costs, partially offset by the favorable impact of foreign exchange. Non-GAAP R&D expenses were $4.6 billion in the fourth quarter of 2024, a decrease of 48% compared with the fourth quarter of 2023. Non-GAAP R&D expenses were $17.9 billion for the full year of 2024, a decrease of 40% compared with the full year of 2023. The declines in both the fourth quarter and full year of 2024 were primarily due to lower charges for business development activity and the favorable impact of foreign exchange, partially offset by increased compensation and benefit costs and higher clinical development spending. Non-GAAP other (income) expense, net, was $5 million of expense in the fourth quarter of 2024 compared with $174 million of expense in the fourth quarter of 2023. The favorability was primarily due to lower foreign exchange losses and lower net interest expense. Non-GAAP other (income) expense, net, was $10 million of expense in the full year of 2024 compared with $219 million of expense in the full year of 2023. The favorability was primarily due to $170 million of income related to the expansion of an existing development and commercialization agreement with Daiichi Sankyo, as well as lower foreign exchange losses in 2024, partially offset by higher net interest expense. The non-GAAP effective tax rate was 16.2% for the fourth quarter and 16.8% for the full year of 2024. Non-GAAP EPS was $1.72 for the fourth quarter of 2024 compared with $0.03 for the fourth quarter of 2023. Non-GAAP EPS was $7.65 for the full year of 2024 compared with EPS of $1.51 for the full year of 2023. The increase in both periods was primarily driven by lower charges for business development transactions and operational strength in the business. The unfavorable effect of foreign exchange partially offset the increase in the full year. A reconciliation of GAAP to non-GAAP net income (loss) and earnings (loss) per share is provided in the table that follows. Fourth Quarter Year Ended $ in millions, except EPS amounts 2024 2023 Dec. 31, 2024 Dec. 31, 2023 EPS GAAP EPS $1.48 $(0.48) $6.74 $0.14 Difference 0.24 0.51 0.91 1.37 Non-GAAP EPS that excludes items listed below 2 $1.72 $0.03 $7.65 $1.51 Net Income (Loss) GAAP net income (loss) 1 $3,743 $(1,226) $17,117 $365 Difference 629 1,292 2,327 3,472 Non-GAAP net income that excludes items listed below 1,2 $4,372 $66 $19,444 $3,837 Excluded Items: Acquisition- and divestiture-related costs 3 $711 $1,233 $2,519 $2,876 Restructuring costs 187 401 888 933 Loss (income) from investments in equity securities 152 (61) 45 (279) Charge for Zetia antitrust litigation settlements - - - 573 Decrease to net income/increase to net loss before taxes 1,050 1,573 3,452 4,103 Estimated income tax (benefit) expense 4 (421) (281) (1,125) (631) Decrease to net income/increase to net loss $629 $1,292 $2,327 $3,472 Pipeline and Portfolio Highlights Merck made important advancements in its broad, diverse pipeline, meeting significant regulatory and clinical milestones throughout the fourth quarter. In oncology, Merck announced positive topline results from the pivotal Phase 3 MK-3475A-D77 trial evaluating the noninferiority of subcutaneous pembrolizumab and berahyaluronidase alfa, in combination with chemotherapy, versus intravenous (IV) KEYTRUDA administered with chemotherapy, for the first-line treatment of adult patients with metastatic NSCLC. Subcutaneous pembrolizumab and berahyaluronidase alfa has the potential to improve the patient experience and increase access for patients and health care providers compared to IV administration. Merck presented new data across multiple hematologic malignancies at the American Society of Hematology Annual Meeting and Exposition in December 2024, including promising Phase 2 data for its investigational antibody-drug conjugate zilovertamab vedotin for the treatment of patients with previously untreated diffuse large B-cell lymphoma. With more than 20 abstracts presented, the data showcased Merck’s continued progress in advancing clinical research for its expanding and diverse hematology pipeline. Merck also achieved several key regulatory milestones in the U.S., Europe, Japan and China. Highlights include the U.S. Food and Drug Administration (FDA) granting Breakthrough Therapy designation to sacituzumab tirumotecan (sac-TMT) for the treatment of certain patients with previously treated advanced or metastatic nonsquamous NSCLC with epidermal growth factor receptor (EGFR) mutations. Additionally, Merck received new approvals for KEYTRUDA-based regimens in Japan and China, as well as for WELIREG and Lynparza in China. In vaccines and infectious diseases, the FDA accepted the Biologics License Application (BLA) for clesrovimab, an investigational prophylactic long-acting monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season and set a Prescription Drug User Fee Act (PDUFA) date of June 10, 2025. This regulatory milestone marks important progress toward having clesrovimab available in time for the 2025-26 RSV season. The filing was based on results from the pivotal Phase 2b/3 study of clesrovimab in infants for the prevention of RSV that was presented at ID Week 2024. In addition, Merck announced topline results from two pivotal Phase 3 trials of the investigational, once-daily, oral, two-drug, single-tablet regimen of doravirine/islatravir (DOR/ISL) in adults with virologically suppressed HIV-1 infection, in line with Merck’s commitment to help address the needs of people living with HIV. In January 2025, Merck also received expanded approval in China for GARDASIL. It is now the first HPV vaccine approved in China for the prevention of certain HPV-related cancers and diseases in males 9-26 years of age. In addition, the European Union’s (EU) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of CAPVAXIVE for pneumococcal vaccination in adults, with a final decision for EU approval expected in the second quarter of 2025. In cardiovascular disease, Merck announced positive topline results from the Phase 3 ZENITH study, evaluating WINREVAIR in adults with pulmonary arterial hypertension (PAH) with World Health Organization (WHO) Group 1 functional class (FC) III or IV at high risk of mortality. Based on the positive results of an interim analysis, an independent data monitoring committee recommended that the study be stopped early due to overwhelming efficacy. In addition, in January 2025, Merck announced the Phase 3 HYPERION study evaluating WINREVAIR in newly diagnosed adults with PAH with FC II or III at intermediate or high risk of disease progression was also stopped early based on the positive results from the interim analysis of the ZENITH trial and a review of the totality of data from the WINREVAIR clinical program to date. All participants in both the ZENITH and HYPERION studies will be offered the opportunity to receive WINREVAIR as part of the open-label, long-term extension study, SOTERIA. Merck continued to execute on its business development strategy. The company announced the closing of an exclusive global license for MK-2010, a novel investigational PD-1/VEGF bispecific antibody from LaNova. Merck also entered into an exclusive global license agreement with Hansoh to evaluate MK-4082, an investigational preclinical oral small molecule glucagon-like peptide (GLP-1) receptor agonist. Notable recent news releases on Merck’s pipeline and portfolio are provided in the table that follows. Oncology FDA Granted Breakthrough Therapy Designation to sac-TMT for the Treatment of Certain Patients With Previously Treated Advanced or Metastatic Nonsquamous NSCLC With EGFR Mutations (Read Announcement) FDA Granted Priority Review to Merck’s Application for WELIREG for the Treatment of Patients With Advanced Pheochromocytoma and Paraganglioma (Read Announcement) Merck Received Positive EU CHMP Opinion for WELIREG as Treatment for Adult Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors and for Certain Previously Treated Adult Patients With Advanced RCC, Based on Results From Phase 2 LITESPARK-004 and Phase 3 LITESPARK-005 Trials (Read Announcement) Merck Received Positive EU CHMP Opinion for KEYTRUDA Plus Chemotherapy as First-Line Treatment for Adult Patients With Unresectable Non-Epithelioid Malignant Pleural Mesothelioma, Based on Results From Phase 2/3 IND.227/KEYNOTE-483 Trial (Read Announcement) KEYTRUDA Approved in China in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as Monotherapy After Surgery as Adjuvant Treatment for Patients With Resectable Stage II, IIIA or IIIB NSCLC, Based on Results From Phase 3 KEYNOTE-671 Trial (Read Announcement) WELIREG Approved in China for Treatment of Adult Patients With Certain Types of VHL Disease-Associated Tumors, Based on Results From Phase 2 LITESPARK-004 Trial (Read Announcement) Merck Announced Phase 3 MK-3475A-D77 Trial of Subcutaneous Pembrolizumab With Berahyaluronidase Alfa Met Primary Endpoints (Read Announcement) Merck Announced Phase 3 KEYLYNK-001 Trial Met Primary Endpoint of Progression-Free Survival in Patients With Advanced Epithelial Ovarian Cancer (Read Announcement) Lynparza Demonstrated Clinically Meaningful Prolonged Survival Benefit in Early Breast Cancer, Based on Results From Phase 3 OlympiA Trial (Read Announcement) Investigational Zilovertamab Vedotin in Combination With R-CHP Demonstrated Complete Response Rate of 100% at 1.75 MG/KG Dose in Previously Untreated Patients With Diffuse Large B-Cell Lymphoma, Based on Results From Phase 2 WaveLINE-007 Trial (Read Announcement) Vaccines Merck Announced FDA Acceptance of BLA for Clesrovimab (MK-1654), an Investigational Long-Acting Monoclonal Antibody Designed to Protect Infants From RSV Disease During Their First RSV Season; FDA Set PDUFA Date of June 10, 2025 (Read Announcement) Merck Received Expanded Approval of GARDASIL for Males in China (Read Announcement) Merck Received Positive EU CHMP Opinion for CAPVAXIVE for Pneumococcal Vaccination in Adults (Read Announcement) Merck Presented New Data From GARDASIL 9 Studies Reinforcing Importance of Gender-Neutral HPV Vaccination in Adults Up to Age 45 at International Papillomavirus Conference 2024 (Read Announcement) Cardiovascular Merck Announced Pivotal Phase 3 ZENITH Trial Evaluating WINREVAIR Met Primary Endpoint at Interim Analysis (Read Announcement) Merck Announced Decision to Stop Phase 3 HYPERION Trial Evaluating WINREVAIR Early and Move to Final Analysis (Read Announcement) Infectious Diseases Merck Announced Topline Results From Pivotal Phase 3 Trials Evaluating Investigational, Once-Daily, Oral, Two-Drug, Single-Tablet Regimen of Doravirine/Islatravir (DOR/ISL) for the Treatment of Adults With Virologically Suppressed HIV-1 Infection (Read Announcement) Full-Year 2025 Financial Outlook The following table summarizes the company’s full-year financial outlook. Full Year 2025 Sales * $64.1 billion to $65.6 billion Non-GAAP Gross margin 2 Approximately 82.5% Non-GAAP Operating expenses 2** $25.4 billion to $26.4 billion Non-GAAP Other (income) expense, net 2 $300 million to $400 million expense Non-GAAP Effective tax rate 2 16.0% to 17.0% Non-GAAP EPS 2*** $8.88 to $9.03 Share count (assuming dilution) Approximately 2.53 billion *The company does not have any non-GAAP adjustments to sales. **Includes $300 million for an anticipated milestone payment to LaNova associated with the technology transfer for MK-2010 expected to be completed in 2025. Outlook does not assume any additional significant potential business development transactions. ***Includes expected one-time charge of approximately $0.09 per share related to the $300 million milestone payment to LaNova upon completion of the technology transfer for MK-2010. Merck has not provided a reconciliation of forward-looking non-GAAP gross margin, non-GAAP operating expenses, non-GAAP other (income) expense, net, non-GAAP effective tax rate and non-GAAP EPS to the most directly comparable GAAP measures, given it cannot predict with reasonable certainty the amounts necessary for such a reconciliation, including intangible asset impairment charges, legal settlements, and income and losses from investments in equity securities either owned directly or through ownership interests in investment funds, without unreasonable effort. These items are inherently difficult to forecast and could have a significant impact on the company’s future GAAP results. Merck anticipates full-year 2025 sales to be between $64.1 billion and $65.6 billion, including a negative impact of foreign exchange of approximately 2% at mid-January 2025 exchange rates. This sales range reflects a decision to temporarily pause shipments of GARDASIL/GARDASIL 9 into China beginning February 2025 through at least mid-year. Merck’s full-year non-GAAP effective income tax rate is expected to be between 16.0% and 17.0%. Merck expects full-year 2025 non-GAAP EPS to be between $8.88 and $9.03, including a negative impact of foreign exchange of approximately $0.35 per share. This range includes an expected one-time charge of $300 million, or approximately $0.09 per share, related to a milestone payment to LaNova, which will be recognized upon completion of the technology transfer for MK-2010. In 2024, non-GAAP EPS of $7.65 was negatively impacted by a net charge of $1.28 per share related to certain asset acquisitions, licensing agreements and collaborations. Consistent with past practice, the financial outlook does not assume additional significant potential business development transactions. Earnings Conference Call Investors, journalists and the general public may access a live audio webcast of the earnings conference call on Tuesday, Feb. 4, at 9 a.m. ET via this weblink . A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures, and slides highlighting the results, will be available at www.merck.com . All participants may join the call by dialing (800) 369-3351 (U.S. and Canada Toll-Free) or (517) 308-9448 and using the access code 9818590. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( www.sec.gov ). Appendix Generic product names are provided below. Pharmaceutical BRIDION (sugammadex) CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) GARDASIL ( Human Papillomavirus Quadrivalent [Types 6, 11, 16 and 18] Vaccine, Recombinant ) GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) JANUMET (sitagliptin and metformin HCl) JANUVIA (sitagliptin) KEYTRUDA (pembrolizumab) LAGEVRIO (molnupiravir) Lenvima (lenvatinib) Lynparza (olaparib) M-M-R II (Measles, Mumps and Rubella Virus Vaccine Live) PREVYMIS ( letermovir ) PROQUAD (Measles, Mumps, Rubella and Varicella Virus Vaccine Live) Reblozyl (luspatercept) REMICADE (infliximab) ROTATEQ (Rotavirus Vaccine, Live, Oral, Pentavalent) SIMPONI (golimumab) VARIVAX (Varicella Virus Vaccine Live) VAXNEUVANCE ( Pneumococcal 15-valent Conjugate Vaccine ) WELIREG ( belzutifan ) WINREVAIR (sotatercept-csrk) Animal Health BRAVECTO (fluralaner) 1 Net income (loss) attributable to Merck & Co., Inc. 2 Merck is providing certain 2024 and 2023 non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors’ understanding of the company’s results because management uses non-GAAP results to assess performance. Management uses non-GAAP measures internally for planning and forecasting purposes and to measure the performance of the company along with other metrics. In addition, annual employee compensation, including senior management’s compensation, is derived in part using a non-GAAP pretax income metric. This information should be considered in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP. For a description of the non-GAAP adjustments, see Table 2a attached to this release. 3 Reflects expenses related to business combinations, including the amortization of intangible assets, intangible asset impairment charges, and expense or income related to changes in the estimated fair value measurement of liabilities for contingent consideration. Also includes integration, transaction and certain other costs associated with acquisitions and divestitures, as well as amortization of intangible assets related to collaborations and licensing arrangements. 4 Includes the estimated tax impacts on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments, as well as a $260 million benefit and a $519 million benefit in the fourth quarter and full year of 2024, respectively, due to reductions in reserves for unrecognized income tax benefits resulting from the expiration of the statute of limitations for assessments related to certain federal tax return years. The benefit recognized in the fourth quarter of 2024 relates to the 2020 federal tax return year and the benefit for the full year of 2024 relates to both the 2020 and 2019 federal tax return years. MERCK & CO., INC. CONSOLIDATED STATEMENT OF OPERATIONS - GAAP (AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES) (UNAUDITED) Table 1 GAAP % Change GAAP % Change 4Q24 4Q23 Full Year 2024 Full Year 2023 Sales $ 15,624 $ 14,630 7% $ 64,168 $ 60,115 7% Costs, Expenses and Other Cost of sales 3,828 3,911 -2% 15,193 16,126 -6% Selling, general and administrative 2,864 2,804 2% 10,816 10,504 3% Research and development 4,585 9,628 -52% 17,938 30,531 -41% Restructuring costs 51 255 -80% 309 599 -48% Other (income) expense, net 126 78 62% (24 ) 466 * Income (Loss) Before Taxes 4,170 (2,046 ) * 19,936 1,889 * Income Tax Provision (Benefit) 425 (821 ) 2,803 1,512 Net Income (Loss) 3,745 (1,225 ) * 17,133 377 * Less: Net Income Attributable to Noncontrolling Interests 2 1 16 12 Net Income (Loss) Attributable to Merck & Co., Inc. $ 3,743 $ (1,226 ) * $ 17,117 $ 365 * Earnings (Loss) per Common Share Assuming Dilution (1) $ 1.48 $ (0.48 ) * $ 6.74 $ 0.14 * Average Shares Outstanding Assuming Dilution (1) 2,537 2,533 2,541 2,547 Tax Rate 10.2 % 40.1 % 14.1 % 80.0 % * 100% or greater (1) Because the company recorded a net loss in the fourth quarter of 2023, no potential dilutive common shares were used in the computation of loss per common share assuming dilution as the effect would have been anti-dilutive. MERCK & CO., INC. FOURTH QUARTER AND FULL YEAR 2024 GAAP TO NON-GAAP RECONCILIATION (AMOUNTS IN MILLIONS, EXCEPT PER SHARE FIGURES) (UNAUDITED) Table 2a GAAP Acquisition and Divestiture Related Costs (1) Restructuring Costs (2) (Income) Loss from Investments in Equity Securities Certain Other Items Adjustment Subtotal Non-GAAP Fourth Quarter Cost of sales $ 3,828 701 121 822 $ 3,006 Selling, general and administrative 2,864 29 16 45 2,819 Research and development 4,585 12 (1) 11 4,574 Restructuring costs 51 51 51 – Other (income) expense, net 126 (31) 152 121 5 Income Before Taxes 4,170 (711) (187) (152) (1,050) 5,220 Income Tax Provision (Benefit) 425 (111) (3) (17) (3) (33) (3) (260) (4) (421) 846 Net Income 3,745 (600) (170) (119) 260 (629) 4,374 Net Income Attributable to Merck & Co., Inc. 3,743 (600) (170) (119) 260 (629) 4,372 Earnings per Common Share Assuming Dilution $ 1.48 (0.23) (0.07) (0.04) 0.10 (0.24) $ 1.72 Tax Rate 10.2% 16.2% Full Year Cost of sales $ 15,193 2,409 495 2,904 $ 12,289 Selling, general and administrative 10,816 117 83 200 10,616 Research and development 17,938 72 1 73 17,865 Restructuring costs 309 309 309 – Other (income) expense, net (24) (79) 45 (34) 10 Income Before Taxes 19,936 (2,519) (888) (45) (3,452) 23,388 Income Tax Provision (Benefit) 2,803 (461) (3) (135) (3) (10) (3) (519) (4) (1,125) 3,928 Net Income 17,133 (2,058) (753) (35) 519 (2,327) 19,460 Net Income Attributable to Merck & Co., Inc. 17,117 (2,058) (753) (35) 519 (2,327) 19,444 Earnings per Common Share Assuming Dilution $ 6.74 (0.81) (0.30) (0.01) 0.21 (0.91) $ 7.65 Tax Rate 14.1% 16.8% Only the line items that are affected by non-GAAP adjustments are shown. Merck is providing certain non-GAAP information that excludes certain items because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing non-GAAP information enhances investors’ understanding of the company’s results because management uses non-GAAP measures to assess performance. Management uses non-GAAP measures internally for planning and forecasting purposes and to measure the performance of the company along with other metrics. In addition, annual employee compensation, including senior management’s compensation, is derived in part using a non-GAAP pretax income metric. The non-GAAP information presented should be considered in addition to, but not as a substitute for or superior to, information prepared in accordance with GAAP. (1) Amounts included in cost of sales primarily reflect expenses for the amortization of intangible assets. Amounts included in selling, general and administrative expenses reflect integration, transaction and certain other costs related to acquisitions and divestitures. Amounts included in research and development expenses primarily reflect the amortization of intangible assets. Additionally, research and development expenses for the full year includes Animal Health intangible asset impairment charges. Amounts included in other (income) expense, net, primarily reflect royalty income and a decrease in the estimated fair value measurement of liabilities for contingent consideration related to the prior termination of the Sanofi-Pasteur MSD joint venture. (2) Amounts primarily include employee separation costs, accelerated depreciation and asset impairments associated with facilities to be closed or divested related to activities under the company's formal restructuring programs. (3) Represents the estimated tax impacts on the reconciling items based on applying the statutory rate of the originating territory of the non-GAAP adjustments. (4) Represents benefits recorded in the fourth quarter and full year due to reductions in reserves for unrecognized income tax benefits resulting from the expiration of the statute of limitations for assessments related to federal income tax return years. The benefit recognized in the fourth quarter relates to the 2020 federal tax return year and the benefit recognized for the full year relates to both the 2020 and 2019 federal tax return years. MERCK & CO., INC. FRANCHISE / KEY PRODUCT SALES (AMOUNTS IN MILLIONS) (UNAUDITED) Table 3 2024 2023 4Q Full Year 1Q 2Q 3Q 4Q Full Year 1Q 2Q 3Q 4Q Full Year Nom % Ex-Exch % Nom % Ex-Exch % TOTAL SALES (1) $15,775 $16,112 $16,657 $15,624 $64,168 $14,487 $15,035 $15,962 $14,630 $60,115 7 9 7 10 PHARMACEUTICAL 14,006 14,408 14,943 14,042 57,400 12,721 13,457 14,263 13,141 53,583 7 8 7 10 Oncology Keytruda 6,947 7,270 7,429 7,836 29,482 5,795 6,271 6,338 6,608 25,011 19 21 18 22 Alliance Revenue – Lynparza (2) 292 317 337 365 1,311 275 310 299 315 1,199 16 18 9 11 Alliance Revenue – Lenvima (2) 255 249 251 255 1,010 232 242 260 226 960 13 14 5 6 Welireg 85 126 139 160 509 42 50 54 72 218 122 123 133 133 Alliance Revenue – Reblozyl (3) 71 90 100 110 371 43 47 52 70 212 58 58 75 75 Vaccines (4) Gardasil/Gardasil 9 2,249 2,478 2,306 1,550 8,583 1,972 2,458 2,585 1,871 8,886 -17 -18 -3 -2 ProQuad/M-M-R II/Varivax 570 617 703 594 2,485 528 582 713 545 2,368 9 9 5 5 Vaxneuvance 219 189 239 161 808 106 168 214 176 665 -9 -9 22 23 RotaTeq 216 163 193 139 711 297 131 156 185 769 -25 -25 -8 -7 Pneumovax 23 61 59 68 74 263 96 92 140 85 412 -12 -12 -36 -34 Hospital Acute Care Bridion 440 455 420 449 1,764 487 502 424 429 1,842 5 5 -4 -3 Prevymis 174 188 208 215 785 129 143 157 175 605 23 23 30 33 Dificid 73 92 96 79 340 65 76 74 87 302 -9 -9 13 13 Zerbaxa 56 62 64 70 252 50 54 53 61 218 14 16 16 18 Noxafil 56 45 41 36 177 60 55 51 46 213 -23 -17 -17 -8 Cardiovascular Winrevair 70 149 200 419 - - - - Alliance Revenue - Adempas/Verquvo (5) 98 106 102 109 415 99 68 92 108 367 1 1 13 13 Adempas (6) 70 72 72 73 287 59 65 65 66 255 11 9 12 14 Virology Lagevrio 350 110 383 121 964 392 203 640 193 1,428 -37 -37 -33 -28 Isentress/Isentress HD 111 89 102 92 394 123 136 119 105 483 -13 -7 -18 -14 Delstrigo 56 60 65 69 249 44 50 54 54 201 28 29 24 26 Pifeltro 42 39 42 40 163 34 38 37 33 142 20 20 15 15 Neuroscience Belsomra 46 53 78 45 222 56 63 58 54 231 -17 -17 -4 1 Immunology Simponi 184 172 189 543 180 180 179 171 710 N/M N/M -24 -23 Remicade 39 35 41 114 51 48 45 43 187 N/M N/M -39 -36 Diabetes (7) Januvia 419 405 278 232 1,334 551 511 581 547 2,189 -58 -56 -39 -36 Janumet 251 224 204 255 935 329 354 255 240 1,177 7 11 -21 -16 Other Pharmaceutical (8) 576 573 644 713 2,510 626 560 568 576 2,333 25 25 8 10 ANIMAL HEALTH 1,511 1,482 1,487 1,397 5,877 1,491 1,456 1,400 1,278 5,625 9 13 4 8 Livestock 850 837 886 889 3,462 849 807 874 808 3,337 10 14 4 9 Companion Animal 661 645 601 508 2,415 642 649 526 470 2,288 8 10 6 7 Other Revenues (9) 258 222 227 185 891 275 122 299 211 907 -13 3 -2 4 N/M - Not Meaningful Sum of quarterly amounts may not equal year-to-date amounts due to rounding. (1) Only select products are shown. (2) Alliance Revenue represents Merck’s share of profits, which are product sales net of cost of sales and commercialization costs. (3) Alliance Revenue represents royalties. (4) Total Vaccines sales were $3,424 million, $3,656 million, $3,675 million and $2,693 million in the first, second, third and fourth quarter of 2024, respectively, and $3,133 million, $3,557 million, $4,002 million and $2,962 million in the first, second, third and fourth quarter of 2023, respectively. (5) Alliance Revenue represents Merck's share of profits from sales in Bayer's marketing territories, which are product sales net of cost of sales and commercialization costs. (6) Net product sales in Merck's marketing territories. (7) Total Diabetes sales were $745 million, $715 million, $592 million and $546 million in the first, second, third and fourth quarter of 2024, respectively, and $950 million, $951 million, $924 million and $876 million in the first, second, third and fourth quarter of 2023, respectively. (8) Includes Pharmaceutical products not individually shown above. (9) Other Revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities. Other Revenues related to the receipt of upfront and milestone payments for out-licensed products were $61 million, $15 million, $15 million and $15 million in the first, second, third and fourth quarter of 2024, respectively, and $51 million, $3 million and $65 million in the first, second and third quarter of 2023, respectively.