Nivolumab/Relatlimab

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 )

点击上方蓝字 关注我们 编者按 乳腺癌已成为女性最常见的恶性肿瘤之一，其中三阴性乳腺癌（TNBC）被称为“最毒”的乳腺癌亚型，因其长期以来治疗预后较差。回首刚刚落下帷幕的2024年，乳腺癌早期和晚期治疗领域涌现了许多令人印象深刻的研究成果，涵盖了化疗、靶向治疗、免疫治疗、抗体偶联药物（ADC）等，其中不乏中国学者领导的原创研究。在本篇乳腺癌年度盘点中，中山大学孙逸仙纪念医院刘强教授将与我们分享2024年TNBC系统治疗的研究进展，共同见证精准治疗时代下，TNBC患者正逐渐走出治疗阴霾，迎接光明未来。 TNBC早期治疗 免疫治疗正走向“C位” TNBC早期治疗领域，最大的亮点是免疫治疗涌现了更多的循证医学证据，逐渐走向了治疗“舞台的中央”，尤其是KEYNOTE-522研究报道了明确的生存获益。 化疗 紫衫联合蒽环仍是TNBC新辅助治疗的标准化疗，在此基础上加入铂类可进一步提高pCR率[1]，但能否转化为EFS获益尚不确定。2024年ASCO报道的BR 15-1 PEARLY研究[2]，旨在评估卡铂＋蒽环类＋环磷酰胺序贯紫杉类方案（卡铂组）对比蒽环类+环磷酰胺序贯紫杉类方案（标准治疗组）新辅助治疗的差异。研究结果显示卡铂组的EFS事件风险显著降低32%（HR 0.68，95%CI：0.50～0.93，P=0.017），5年EFS提高7.5%（74.4% vs 81.9%）。该研究为TNBC新辅助治疗铂类的加入进一步提供了EFS获益的证据。 靶向治疗 GeparOLA、OlympiA研究已经证实PARP抑制剂（PARPi）在gBRCA突变型HER2阴性早期乳腺癌中的治疗获益[3-4]。2024年4月，《自然》（Nature）发表的II/III期PARTNER研究[5]，则是针对gBRCA野生型的TNBC患者，给予卡铂＋紫杉醇±奥拉帕利新辅助治疗，序贯3个周期的蒽环类药物化疗。结果显示联合奥拉帕利组与单纯化疗组的pCR率（51.1% vs 52.4%，P=0.753）、3年EFS（80.2% vs 79.1%，P＞0.9）和OS（90% vs 87.2%，P=0.7）均无显著差异。这些结果表明，在PARPi的早期治疗应用中仍需考虑gBRCA等生物标志物状态。 免疫治疗 与之前单纯化疗时代相比，免疫检查点抑制剂（ICIs）已经改变了TNBC早期治疗的临床实践。其中，III期KEYNOTE-522研究入组患者是未接受过治疗的II期或III期TNBC，术前接受4个周期的帕博利珠单抗联合化疗（卡铂+紫衫序贯AC或EC），术后继续帕博利珠单抗辅助治疗，而对照组仅接受术前化疗。2022年发表于NEJM的结果已经证实，帕博利珠单抗组的pCR率（64.8% vs 51.2%，P<0.001）和3年EFS（84.5% vs 76.8%，HR 0.63，95%CI：0.48～0.82；P<0.001）均显著高于对照组[6-7]。2024年ESMO大会进一步报道了OS结果，帕博利珠单抗组的5年OS提高近5%（86.6% vs 81.7%），死亡风险相对降低34%（HR 0.66，95%CI：0.50～0.87，P=0.002）[8]。这些研究结果表明，KEYNOTE-522的新辅助和辅助免疫联合化疗方案能够为II/III期TNBC患者带来明确的生存获益。但是2024年底SABCS大会公布的NSABP B-59/GBG-96-GeparDouze研究结果显示PD-L1抗体的加入不能改善TNBC的生存，提示免疫治疗的不同药物选择会影响疗效。 △KEYNOTE-522研究OS K-M曲线 2024年SABCS大会报道、JAMA同步发表的CamRelief研究[9]，则是由复旦大学附属肿瘤医院邵志敏教授领导的全国多中心、III期临床试验，针对入组的复发高危早期和局晚期TNBC患者，术前给予卡瑞利珠单抗联合化疗（紫衫+卡铂序贯EC）或化疗新辅助治疗，术后则给予卡瑞利珠单抗或标准治疗。结果显示卡瑞利珠单抗组的pCR率相较于化疗组显著提高（56.8% vs 44.7%；P=0.004），而且pCR率不受PD-L1表达、淋巴结状态或基线疾病分期的影响。该研究为TNBC新辅助免疫治疗提供了中国原研方案的循证医学证据。 目前，对于TNBC早期免疫治疗的获益，此前来自辅助治疗阶段的免疫强化研究基本上是失败的。针对辅助免疫治疗的强化，2024年ASCO大会报道的A-BRAVE研究[10]，入组了新辅助化疗后残留病灶或初始手术和辅助化疗后有高复发风险的早期TNBC患者，给予阿维鲁单抗辅助治疗或观察。结果显示总体人群（68.3% vs 63.2%，HR 0.81，95%CI：0.61～1.09，P=0.172）和non-pCR亚组（66.9% vs 60.7%，HR 0.80，95%CI：0.58～1.10，P=0.170）的3年DFS率均无统计学差别。然而，阿维鲁单抗组的3年OS率相较于对照组提高了8.5%（84.8% vs 76.3%，HR 0.66；95%CI：0.45～0.97，P=0.035），尤其在PD-L1小于或等于21%、TILs的比例小于10%或残留肿瘤负荷较高的患者获益更明显。 乳腺癌新辅助免疫治疗仍有许多需要厘清的问题。2024年CSCO BC发布的《乳腺癌免疫治疗临床应用专家共识》[11]，对早期免疫治疗的人群选择、疗程、化疗“搭档”、预测性生物标志物等问题均有所讨论。随着循证医学证据的丰富，未来将会有更加清晰的答案。 降级治疗 2024年4月和6月在JAMA和JAMA Oncology杂志上分别发表了两篇早期TNBC免除化疗的文章，显示对于部分I-II期的早期乳腺癌，没有接受任何化疗，5年的无复发生存也达到了70-80%，尤其是那些肿瘤浸润淋巴细胞（TILs）比较高的患者，提示部分早期TNBC患者应用手术+放疗进行治疗就足够了，但如何识别出这部分患者，也是我们面临的临床问题。我们近期一篇即将发表ctDNA在早期TNBC的研究文章，其中21.7%的早期TNBC（包括部分IIIc期患者）的ctDNA在整个治疗过程中全阴性，这些患者随访过程中没有一例出现复发转移，说明ctDNA的价值独立于且优于传统的TNM分期，可准确反映患者的系统肿瘤负荷（systemic tumor burden）和全身转移风险，我们也正在据此设计根据ctDNA免除或降级化疗的临床研究，希望能够减少不必要的全身治疗。 2024年三阴性乳腺癌系统治疗进展 TNBC晚期治疗 创新方案更加“多元化” 免疫联合化疗已经成为国内外晚期PD-L1阳性TNBC的一线治疗标准。2024年的研究进展主要体现在更多的免疫治疗药物，以及更多的化疗模式探索。此外，当前备受关注的ADC也为晚期TNBC提供了更多的后线治疗选择。 免疫和化疗 KEYNOTE-355研究奠定了晚期TNBC免疫联合化疗的一线治疗地位。解放军总医院肿瘤医学部江泽飞教授领导的TORCHLIGHT研究则为中国晚期TNBC患者提供了新的一线治疗方案。该研究显示，在白蛋白紫杉醇基础上联合特瑞普利单抗可显著延长PD-L1阳性患者的PFS（8.4 vs 5.6个月，HR 0.65，95%CI：0.470～0.906，P=0.0102），且死亡风险也减低38%（32.8 vs 19.5个月，HR 0.62，95%CI：0.414～0.914，P=0.0148）[12]，意向性治疗（ITT）人群也有相似获益。TORCHLIGHT研究成果的论文于2024年1月发表于Nature Medcine。 2024年Nature Medcine的发表了另一项中国学者的TNBC免疫治疗研究，即中国医学科学院肿瘤医院徐兵河院士/马飞教授团队开展的首个探索节拍化疗联合免疫治疗的贝叶斯适应性随机II期试验结果[13]。该研究的随机分组包括：长春瑞滨节拍化疗（NVB组）、长春瑞滨节拍化疗联合PD-1抑制剂（anti-PD1+NVB组）、长春瑞滨节拍化疗联合顺铂常规化疗和PD-1抑制剂（DDP组）、长春瑞滨节拍化疗联合贝伐珠单抗和PD-1抑制剂（BEV组），或长春瑞滨+卡培他滨+环磷酰胺三药节拍化疗联合PD-1抑制剂（VEX组）。研究结果显示，VEX组（69.7%）和DDP组（73.7%）患者的DCR最高。VEX组患者中位PFS最长，为6.6个月。亚组分析显示，在TNBC患者中，VEX组的中位PFS可长达9.8个月。对外周血免疫细胞亚群的探索性分析表明，系统免疫状态可能是影响节拍化疗联合免疫治疗疗效的重要因素。该研究的临床和转化数据证实了节拍性VEX化疗联合PD-1抑制剂可作为晚期乳腺癌患者的一种治疗选择。 2024年ESMO大会报道的TRIPLE-B研究[14]，是一项2×2析因设计的IIb期试验。该研究则根据同源重组修复缺陷（HRD）选择铂类和紫衫化疗，在此基础上联合阿替利珠单抗。研究结果显示，HRD状态并不能预测化疗（相互作用P=0.1553）；紫衫＋阿替利珠单抗组、卡铂-环磷酰胺＋阿替利珠单抗组、卡铂-环磷酰胺、紫衫组的中位PFS分别为6.5、5.4、5.3、4.4个月。 ADC和靶向治疗 中国原创ADC和靶向治疗药物在TNBC领域大放异彩。2024年ASCO大会上，徐兵河院士报告了III期OptiTROP-Breast01研究[15]，Trop2 ADC芦康沙妥珠单抗（SKB264）用于经治局部复发性或转移性TNBC，可相较于化疗显著延长PFS（6.7 vs 2.5个月，HR 0.32，95%CI：0.22～0.44，P＜0.00001），OS尚未成熟，但已表现出芦康沙妥珠单抗的获益趋势（HR 0.53；95%CI 0.36～0.78；P=0.0005）。 2024年ESMO大会上，报道了中山大学附属孙逸仙纪念医院宋尔卫院士和北京大学肿瘤医院乳腺肿瘤科李惠平教授等领导的一项III期研究[16]，对gBRCA突变的HER2-晚期乳腺癌患者使用我国原研的PARPi氟唑帕利±阿帕替尼，或医生选择的化疗。结果显示与化疗相比，氟唑帕利联合治疗组（11.0 vs 3.0个月，HR 0.27，95%CI：0.17～0.43，P＜0.0001）和氟唑帕利单药组（6.7 vs 3.0个月，HR 0.49，95%CI：0.32～0.75，P=0.0004）均有显著的PFS获益；OS也有获益趋势（HR分别为0.58和0.61）。期待这些新型靶向和ADC治疗方案能够进一步改变临床实践，为晚期TNBC患者提供更多治疗选择。 2024年三阴性乳腺癌系统治疗进展 突破传统分子亚型 探索个体化的精准治疗策略 传统的乳腺癌分子亚型就包括HR+、HER2+和TNBC，其中TNBC又被称为“垃圾桶”，因其肿瘤异质性非常复杂，是一大类没有可操作分子靶点的乳腺癌集合。随着精准分型的探索深入，有望在TNBC中筛选出更加个体化的精准治疗策略。 早期治疗 邵志敏教授团队发表于BMJ上的前瞻性III期BCTOP-T-A01研究[17]，使用其自主研发的自主研发的“多基因模型”将早期TNBC患者分为高危、低危组，其中高危组患者接受4个周期的多西他赛+表阿霉素+环磷酰胺序贯4个周期“吉西他滨+顺铂（TEC*4-GP*4）的强化辅助治疗；标准治疗组为4个周期的表阿霉素+环磷酰胺序贯4个周期的多西他赛（EC*4-T*4）。低危组患者同样接受标准方案化疗（EC*4-T*4）。结果显示，强化治疗方案显著提高了高危患者的3年DFS（90.9% vs 80.6%；HR 0.51；95%CI：0.28～0.95，P=0.03）和3年RFS（92.6% vs 83.2%；HR 0.50；95%CI：0.25～0.98，P=0.04）。 在免疫治疗方面，2024年ASCO大会报道的ISPY2.2研究，根据乳腺癌患者的生物标志物，形成了6种疗效预测亚型（Response-Predictive Subtype，RPS）：S1（HR+/HER2-/Immune-/DRD-）、S2（HR-/HER2-/Immune-/DRD-）、S3（HER2-/Immune+）、S4（HER2-/Immune-/DRD+）、S5（HER2+/基底样）、S6（HER2+/管腔样）。在Dato-DXd（Trop2 ADC）联合度伐利尤单抗的队列中，免疫标志物阳性（Immune+）患者的pCR率达到了43%（20/40），模型pCR率达65%[18]。这种多基因分类方法有望促进早期TNBC患者的个体化辅助治疗策略。2024年ESMO大会报道的BELLINI研究队列C和D入组了TILs水平高（≥50%）的早期TNBC患者，使用纳武利尤单抗联合伊匹木单抗（PD-1＋CTLA-4）双免新辅助治疗的pCR率和MPR率分别为33%何53%；使用纳武利尤单抗联合Relatlimab（PD-1＋LAG3单抗）双免新辅助治疗的pCR率分别为47%和73%[19]。该研究表明TILs可作为筛选双免新辅助治疗的标志物，而且TILs水平高的患者接受无化疗的双免新辅助治疗有较好的疗效反应。 △I-SPY 2.2研究的RPS分型与传统乳腺癌分子亚型的分布 晚期治疗 邵志敏教授团队于2019年提出了TNBC的复旦分型（FUSCC）：腔面雄激素受体型（LAR）、免疫调节型（IM）、基底样免疫抑制型（BLIS）和间质型（MES）。随后逐步开展临床研究验证，既往报道的FUTURE、FUTURE-C-Plus研究为伞型单臂研究，而2024年发表于Lancet Oncology的FUTURE-SUPER研究则是一项伞型随机对照试验。该研究针对晚期TNBC不同FUSCC亚型患者使用不同的精准治疗方案（见下图），结果显示与当前标准化疗（白蛋白结合型紫杉醇）相比，FUSCC精准治疗策略能够显著延长PFS（11.3 vs 5.8个月，HR 0.44，95%CI：0.30～0.65，P＜0.0001）。这些临床研究有望推动复旦分型进一步走进临床实践。 △FUTURE-SUPER研究设计和PFS 2024年HR+/HER2-乳腺癌系统治疗进展 YBCC工作回顾 构建中国年轻乳腺癌诊疗体系 我国乳腺癌中位发病年龄相较于欧美国家更靠前，年轻乳腺癌患者有着独特的医疗和社会心理需求，需要临床医生给予更加个体化的诊疗决策，年轻乳腺癌中三阴乳腺癌占比也比较高。2022年首届中国年轻乳腺癌诊疗共识大会举行，YBCC专家组发布了首版《中国年轻乳腺癌诊疗专家共识》，2023年2月发表在中华医学杂志上，至今阅读已超过两万次，下载三千五百多次，反映了医学界和大众对于年轻乳腺癌的高度关注。此后，中山大学孙逸仙纪念医院在全国率先开设了年轻乳腺癌专家门诊，并在全国各地推广和设立了多个年轻乳腺癌专家门诊，有力推动了年轻乳腺癌的规范化诊疗水平提升。 2024年12月27—28日，2024逸仙乳腺大会暨第二届中国年轻乳腺癌诊疗共识大会在广州举行，这次大会再次引起了国内外专家的极大关注，并推出了中国年轻乳腺癌患者生活质量量表、乳腺癌/卵巢癌遗传基因突变致病力风险评估系统、YBCC诊疗共识（大众科普版）。这些行业标准的发布，将在多学科专家的协作下，为年轻乳腺癌患者带来更加全面的诊疗支持系统，为患者赢得“不仅活下去，更要活得好”的健康人生。 2024年三阴性乳腺癌系统治疗进展 参考文献 上下滑动查看更多内容 [1]von Minckwitz G, Schneeweiss A, Loibl S, et al. Neoadjuvant carboplatin in patients with triple-negative and HER2-positive early breast cancer (GeparSixto; GBG 66): a randomised phase 2 trial. Lancet Oncol. 2014;15(7):747-756. doi:10.1016/S1470-2045(14)70160-3 [2]Sohn J, et al. A randomized, multicenter, open-label, phase III trial comparing anthracyclines followed by taxane versus anthracyclines followed by taxane plus carboplatin as (neo) adjuvant therapy in patients with early triple-negative breast cancer: Korean Cancer Study Group BR 15-1 PEARLY trial[J]. J Clin Oncol, 2024, 42(Suppl 17):LBA502. [3]Fasching PA, Link T, Hauke J, et al. Neoadjuvant paclitaxel/olaparib in comparison to paclitaxel/carboplatinum in patients with HER2-negative breast cancer and homologous recombination deficiency (GeparOLA study). Ann Oncol. 2021;32(1):49-57. doi:10.1016/j.annonc.2020.10.471 [4]Tutt ANJ, Garber JE, Kaufman B, et al. Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer. 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Lancet Oncol. 2024;25(2):184-197. doi:10.1016/S1470-2045(23)00579-X [21]中国临床肿瘤学会乳腺癌专家委员会,中国抗癌协会乳腺癌专业委员会,中华医学会外科学分会乳腺外科学组.中国年轻乳腺癌诊疗专家共识（2022）[J].中华医学杂志,2023,103(6):387-403.DOI:10.3760/cma.j.cn112137-20220907-01895. （来源：《肿瘤瞭望》编辑部） 声 明 凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。