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MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
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Management's discussion and analysis of financial condition and results of operations is provided as a supplement to and should be read in conjunction with the consolidated financial statements and related notes included elsewhere in this 2025 Form 10-K to enhance the understanding of our results of operations, financial condition and cash flows. Certain amounts in this 2025 Form 10-K may not sum due to rounding. Percentages have been calculated using unrounded amounts.
The comparison of 2024 to 2023 results has been omitted from this Form 10-K and is incorporated by reference from our Form 10-K for the year ended December 31, 2024 "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations" filed on February 12, 2025.
EXECUTIVE SUMMARY
Bristol-Myers Squibb Company is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Refer to the Summary of Abbreviated Terms at the end of this 2025 Form 10-K for definitions of capitalized terms used throughout the document.
In 2025, we have achieved multiple regulatory approvals across our portfolio, including the: (i) approval of Breyanzifor adults with relapsed or refractory FL and MCL in the EU, (ii) approval of Camzyosfor the treatment of symptomatic obstructive HCM in Japan, (iii) approval of Opdivo+ Yervoyas a first-line treatment of adult patients with unresectable or advanced HCC in both the U.S. and the EU, (iv) approval of Opdivo+ Yervoyfor first-line treatment of adults and pediatric patients 12 years and older with unresectable or metastatic MSI-High or dMMR colorectal cancer in the U.S. and Japan, (v) approval of Opdivoas a perioperative regimen for resectable high risk NSCLC in the EU, (vi) approval of Opdivo Qvantigfor use across multiple adult solid tumors in the EU, and (vii) approval of Breyanzi for the treatment of adults with relapsed or refractory MZL in the U.S. Additionally, we received label updates from the FDA that have reduced or removed certain patient monitoring requirements associated with the use of Camzyos, Breyanziand Abecma.
We continue to pursue activities to advance and expand our pipeline through our internal research and development efforts as well as through business development activities. In 2025, the Company (i) acquired Orbital Therapeutics, which provided the Company with full rights to OTX-201, a preclinical in vivoCAR T-cell therapy currently in IND-enabling studies for autoimmune disease, (ii) entered into a strategic collaboration with BioNTech to co-develop and co-commercialize BioNTech's investigational bispecific antibody pumitamig (BNT327/BMS986545) across multiple solid tumor types, (iii) acquired a global exclusive license from Philochem for OncoACP3, a radiopharmaceutical therapeutic and diagnostic agent targeting prostate cancer, and (iv) expanded our development and manufacturing capabilities by opening a new radiopharmaceutical facility in Indianapolis, Indiana, which will support RPTs acquired in connection with the RayzeBio acquisition. For additional information relating to our acquisitions, divestitures, licensing and other arrangements refer to "Item 8. Financial Statements and Supplementary Data - Note 3. Alliances" and "Item 8. Financial Statements and Supplementary Data- Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements".
We remain committed to the strategic allocation of resources and investing in areas that maximize value and drive sustainable growth. As previously announced, our ongoing strategic productivity initiative includes acceleration of the delivery of medicines to patients by evolving and streamlining our enterprise operating model in key areas such as R&D, manufacturing, commercial and other functions. We continue to expect to realize approximately $2.0 billion in cost savings by the end of 2027 in connection with the 2025 expansion of our ongoing strategic productivity initiative. The exit costs resulting from these actions are included in our updated 2023 Restructuring Plan.
Financial Highlights
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|
|
|
|
|
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|
|
|
|
|
|
|
Year Ended December 31,
|
|
Dollars in millions, except per share data
|
2025
|
|
2024
|
|
Total Revenues
|
$
|
48,194
|
|
|
$
|
48,300
|
|
|
|
|
|
|
|
Diluted Earnings/(Loss) Per Share
|
|
|
|
|
GAAP
|
$
|
3.46
|
|
|
$
|
(4.41)
|
|
|
Non-GAAP
|
6.15
|
|
|
1.15
|
|
Revenues were relatively flat in 2025. Demand increased across the Growth Portfolio and for Eliquis, which was offset by the impact of generics across the remainder of the Legacy Portfolio. Additionally, revenues were impacted by higher U.S. government channel rebates in 2025. We expect continued generic erosion within our Legacy Portfolio in 2026 primarily due to Revlimid and Pomalystin the U.S.
The $7.87 change in GAAP EPS in 2025 was primarily due to lower Acquired IPRD charges, the impact of certain specified items, including lower amortization of acquired intangible assets and lower intangible asset impairment charges, and cost savings from our ongoing strategic productivity initiative in 2025. After adjusting for specified items, the $5.00 increase in non-GAAP EPS was primarily due to the aforementioned lower Acquired IPRD charges and cost savings from our ongoing strategic productivity initiative.
Our non-GAAP financial measures, including non-GAAP earnings and related EPS information, are adjusted to exclude specified items that represent certain costs, expenses, gains and losses and other items impacting the comparability of financial results. For a detailed listing of all specified items and further information, reconciliations and changes to our non-GAAP financial measures refer to "-Non-GAAP Financial Measures."
Economic and Market Factors
Governmental Actions
As regulators continue to focus on prescription drugs, our products are facing increased pressures across the portfolio. These pressures stem from legislative and policy changes, including price controls, pharmaceutical market access, discounting, changes to tax and importation laws and other restrictions in the U.S., EU and other regions around the world. These pressures have resulted in lower prices, lower reimbursement rates and smaller populations for whom payers will reimburse, which have negatively impacted, and may continue to negatively impact our results of operations (including intangible asset impairment charges), operating cash flow, liquidity and financial flexibility. In August 2024, as part of the first round of government price setting pursuant to the IRA, the HHS announced the "maximum fair price" for a 30-day equivalent supply of Eliquis, which applies to the U.S. Medicare channel effective January 1, 2026. In November 2025, the HHS announced the "maximum fair price" for a 30-day supply of Pomalyst, which applies to the U.S. Medicare channel effective January 1, 2027. In January 2026, the HHS selected Orenciaas a medicine subject to "negotiation" for government-set prices beginning in 2028. It is possible that more of our products could be selected in future years based upon the selection criteria currently utilized by the HHS or potentially expanded future criteria, or that the "maximum fair price" for our previously selected products could be renegotiated, each of which could, among other things, accelerate revenue erosion prior to expiry of intellectual property protections. We continue to evaluate the impact of the IRA on our results of operations, and it is possible that these changes may result in a material impact on our business and results of operations.
In December 2025, we announced the U.S. Government Agreement pursuant to which we agreed to, among other things: (i) provide Eliquis for free to the Medicaid program effective January 1, 2026; (ii) donate more than seven tons of Eliquis API to fill the U.S. Strategic Active Ingredient Reserve; (iii) enable direct-to-patient access to Sotyktu, Zeposia, Reyataz, Baracludeand Orenciafor cash-paying patients at discounts approximately 80% off current list prices; (iv) adopt a more balanced pricing approach for new launches across developed nations; and (v) continue to expand domestic production. This agreement, and any potential future agreements with government entities, by us or our competitors, could result in reduced prices and reimbursement for certain of our or competing products and may impact our cash flows and results of operations.
Further, the U.S. and other countries have recently imposed, and may continue to impose, new tariffs. While pharmaceuticals are largely exempt from the tariffs imposed in 2025, such exemptions may be terminated or may not apply to any future tariffs. In accordance with the U.S. Government Agreement, BMS will receive certain U.S. tariff relief until January 2029 and will not be subject to future pricing mandates in the U.S., however, such exemptions may be terminated or may not be extended. In addition, we remain subject to any current or future pricing mandates implemented outside of the U.S. It is possible that such regulations may result in a material impact on our business and results of operations.
At the state level, multiple states have passed, are pursuing or are considering government action via legislation or regulations to change drug pricing and reimbursement (e.g., establishing prescription drug affordability boards, implementing manufacturer mandates tied to the Federal Public Health Service Act drug pricing program, etc.). Some of these state-level actions may also influence federal and other state policies and legislation. Given the current uncertainty surrounding the adoption, timing and implementation of many of these measures, as well as pending litigation challenging such laws, we are unable to predict their full impact on our business. However, such measures could modify or decrease access, coverage, or reimbursement of our products, or result in significant changes to our sales or pricing practices, which could have a material impact on our revenues and results of operations. With respect to the Federal Public Health Service Act drug pricing program, certain states have enacted laws regulating manufacturer pricing obligations under the program to date. Several additional states are considering similar potential legislation or other government actions, and we expect other states may do the same in the future.
See risk factors on these items included under "Part I-Item 1A. Risk Factors-Product, Industry and Operational Risks-Increased pricing pressure and other restrictions in the U.S. and abroad continue to negatively affect our revenues and profit margins", "-We could lose market exclusivity of a product earlier than expected", "-We could experience difficulties, delays and disruptions in our supply chain as well as in the manufacturing, distribution and sale of our products" and "-Changes to tax regulations could negatively impact our earnings".
Significant Product and Pipeline Approvals
The following is a summary of the significant approvals received:
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|
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|
|
Breyanzi
|
December 2025
|
FDA approval of Breyanzifor the treatment of adult patients with relapsed or refractory MZL who have received at least two prior lines of systemic therapy.
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|
|
|
|
|
|
|
|
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Breyanzi
|
November 2025
|
EC approval of Breyanzifor the treatment of adult patients with relapsed or refractory MCL after at least two lines of systemic therapy including a Bruton's tyrosine kinase inhibitor.
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|
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|
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|
|
|
|
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Augtyro
|
November 2025
|
Japan's Ministry of Health Labour and Welfare approval of Augtyrofor the treatment of NTRK fusion-positive, advanced or recurrent solid tumors.
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|
|
|
|
|
|
|
|
|
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Opdivo + Yervoy
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August 2025
|
Japan's Ministry of Health Labour and Welfare approval of Opdivo+ Yervoyfor the treatment of unresectable advanced or recurrent microsatellite instability-high colorectal cancer.
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|
|
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|
|
|
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Opdivo + Yervoy
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June 2025
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Japan's Ministry of Health Labour and Welfare approval of Opdivo+ Yervoyfor the treatment of unresectable HCC.
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|
|
|
|
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|
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|
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Inrebic
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June 2025
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Japan's Ministry of Health Labour and Welfare approval of Inrebicfor the treatment of myelofibrosis.
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|
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|
|
|
|
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Opdivo Qvantig
|
May 2025
|
EC approval of Opdivo Qvantigfor use across multiple adult solid tumors as monotherapy, monotherapy maintenance following completion of intravenous Opdivoplus Yervoycombination therapy, or in combination with chemotherapy or cabozantinib.
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|
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Opdivo
|
May 2025
|
EC approval for perioperative regimen of neoadjuvant Opdivoand chemotherapy followed by surgery and adjuvant Opdivofor the treatment of resectable NSCLC at high-risk of recurrence in adult patients whose tumors have PD-L1 expression ≥1%.
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|
|
|
|
|
|
|
|
|
|
Opdivo + Yervoy
|
April 2025
|
FDA approval of Opdivo+ Yervoyas a first-line treatment of adult patients with unresectable or metastatic HCC.
|
|
|
|
|
|
|
|
|
|
|
|
Opdivo + Yervoy
|
April 2025
|
FDA approval of Opdivo + Yervoyas a first-line treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient CRC.
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|
|
|
|
|
|
|
|
|
|
|
Camzyos
|
March 2025
|
Japan's Ministry of Health Labour and Welfare approval of Camzyosfor the treatment of oHCM.
|
|
|
|
|
|
|
|
|
|
|
|
Breyanzi
|
March 2025
|
EC approval of Breyanzifor the treatment of adult patients with relapsed or refractory FL after two or more lines of systemic therapy.
|
|
|
|
|
|
|
|
|
|
|
|
Opdivo + Yervoy
|
March 2025
|
EC approval of Opdivo+ Yervoyfor the first-line treatment of adult patients with unresectable or advanced HCC.
|
|
|
|
|
|
|
|
|
|
|
|
Augtyro
|
February 2025
|
EC approval for Augtyroas a treatment for adult patients with ROS1-positive NSCLC and for adult and pediatric patients 12 years of age and older with NTRK-positive solid tumors.
|
Refer to "-Product and Pipeline Developments" for all of the developments in our marketed products and late-stage pipeline in 2025 and in early 2026.
Strategy
Our principal strategy is to combine the resources, scale and capability of a large pharmaceutical company with the speed, agility and focus on innovation typically found in the biotech industry. Our focus as a biopharmaceutical company is on discovering, developing and delivering transformational medicines for patients facing serious diseases in areas where we believe that we have an opportunity to make a meaningful difference: oncology, hematology, immunology, cardiovascular, neuroscience and other areas where we can also create long-term value. Our priorities are to focus on transformational medicines where we have a competitive advantage, drive operational excellence throughout the organization and strategically allocate capital for long-term growth and shareholder returns.
Our R&D strategy is designed to invest in the most promising science and to consistently execute in a way that translates that science into new medicines with the highest probability of success. To execute this strategy, we focus on three key priorities: science, execution, and value. We have a disease-focused strategy that incorporates lead and supporting assets and pursues high-impact medicines to advance standards of care across our core therapeutic areas. To accelerate progress, we have taken steps to increase the probability of success in our clinical trials and are infusing artificial intelligence throughout our R&D process. Together, these efforts enable us to prioritize programs more deliberately and effectively, delivering novel therapies for patients and driving long-term growth.
In oncology, we are focused on extending and strengthening our leadership in IO, as well as diversifying beyond IO. During 2025, we entered into a global strategic collaboration with BioNTech for the co-development and co-commercialization of pumitamig (BNT327/BMS986545), a potentially transformative PD-L1/VEGF-A bispecific that could set a new standard of care across multiple tumor types. Additionally, we believe we have significant opportunity in radiopharmaceuticals as a new oncology modality with opportunities to advance RYZ101, RYZ401 and RYZ801. In hematology, we see significant potential with our targeted protein degradation platform, which includes potentially first-in-class CELMoDs currently under investigation for multiple myeloma with iberdomide and mezigdomide and lymphoma with golcadomide as well as a potentially first-in-class BCL6 LDD with BMS-986458. In cell therapy, we are building on our expertise and leadership, developing next generation CAR-T treatments with first-in-class potential, includingin vivoCAR-T cell therapies. We are investigating arlo-cel in pivotal studies targeting multiple myeloma and advancing development for zola-cel (CD19-targeted NEX-T), an asset aimed at resetting the immune system, in autoimmune diseases. We are exploring zola-cel's potential in multiple disease areas, including SLE, SSc and other indications. Additionally, in immunology, we are developing admilparant, our LPA1 antagonist targeting pulmonary fibrosis with ongoing registrational clinical trials for IPF and PPF. In cardiovascular diseases, the LIBREXIA clinical program, in partnership with Johnson & Johnson, includes registrational trials in atrial fibrillation and secondary stroke prevention for milvexian. Lastly, we have a growing, diverse neuroscience pipeline that includes several ongoing Phase III studies as well as several investigational programs aimed at advancing novel therapeutic approaches across neurological diseases.
We are driving commercial execution in our key first-in-class and/or best-in-class marketed products, where we continue to expand and see potential for further expansion into the future. We have established a strong foundation in IO with Opdivo, Yervoyand Opdualag,and have expanded our leadership in the area with the addition of Opdivo Qvantig. In hematology, Reblozyl, continues to drive market share in the first line RS-positive and RS-negative settings in the U.S., and in cardiovascular diseases, Camzyoscontinues to provide benefits to patients with oHCM. Additionally, in cell therapy, we continue to expand the range of B-cell malignancies treated by Breyanzi. Finally, in immunology and neuroscience, respectively, registrational studies are ongoing for Sotyktuin systemic lupus erythematosus and Sjögren's disease and are ongoing or planned for Cobenfyin Alzheimer's Disease Psychosis, Alzheimer's Disease Agitation, Alzheimer's Disease Cognition, Bipolar I Disorder and Autism spectrum disorder irritability. Together with our digital capabilities, including the deployment of artificial intelligence, we are enhancing commercial productivity through more effective clinician engagement and targeted patient outreach.
We remain committed to the strategic allocation of resources and investing in areas that maximize value and drive sustainable growth. We previously announced a strategic productivity initiative to accelerate the delivery of medicines to patients by evolving and streamlining our enterprise operating model in key areas such as R&D, manufacturing, commercial and other functions. We continue to expect to realize approximately $2.0 billion in cost savings by the end of 2027 in connection with the 2025 expansion of our ongoing strategic productivity initiative. The exit costs resulting from these actions are included in our updated 2023 Restructuring Plan.
Our strategy extends well beyond the discovery, development and delivery of transformative medicines that help patients prevail over serious diseases. We understand the future of our employees, our communities, our planet, and our business are inextricably linked. Accordingly, we seek to mobilize our capabilities and resources to positively impact the communities where we live, work, and serve around the world. As we work to transform patients' lives through science, we operate with effective governance, uncompromising quality and compliance, and the highest ethical standards to deliver our mission. These values have been central to who we are, what we do, and how we do it since our company was founded in 1887. We believe that driving long-term business value is at the heart of living our purpose, enabling us to be leaders and difference-makers for generations to come.
Acquisitions, Divestitures, Licensing and Other Arrangements
For detailed information on significant acquisitions, divestitures, collaborations, licensing and other arrangements during 2025 refer to "Item 8. Financial Statements and Supplementary Data -Note 3. Alliances" and "-Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements."
RESULTS OF OPERATIONS
Regional Revenues
The composition of the changes in revenues was as follows:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
Dollars in millions
|
2025
|
|
2024
|
|
% Change
|
|
Foreign Exchange(b)
|
|
United States
|
$
|
33,279
|
|
|
$
|
34,105
|
|
|
(2)
|
%
|
|
-
|
|
|
International
|
13,828
|
|
|
13,199
|
|
|
5
|
%
|
|
2
|
%
|
|
Other revenues(a)
|
1,087
|
|
|
996
|
|
|
9
|
%
|
|
-
|
|
|
Total Revenues
|
$
|
48,194
|
|
|
$
|
48,300
|
|
|
-
|
%
|
|
1
|
%
|
(a) Other revenues include royalties and alliance-related revenues for products not sold by our regional commercial organizations, including royalties received from Merck on Winrevair*.
(b) Foreign exchange impacts were derived by applying the prior period average currency rates to the current period revenues.
United States
•U.S. revenues decreased 2% in 2025 reflecting higher demand across the Growth Portfolio and for Eliquis, partially offset by the impact of generics on Revlimid, Sprycel and Abraxane.Additionally, U.S. revenues were impacted by higher government channel rebates in 2025. Average net selling prices decreased by 4% in 2025 compared to 2024.
International
•International revenues increased 5% in 2025 primarily due to higher demand across the Growth Portfolio and for Eliquis, partially offset by generic erosion within the remainder of the Legacy Portfolio. Excluding the impacts of foreign exchange, international revenues increased 3%.
No single country outside the U.S. contributed more than 10% of total revenues in 2025 and 2024. Our business is typically not seasonal; however, in the first quarter we typically see an unwinding of sales channel inventory build-up from the fourth quarter of the prior year.
GTN Adjustments
We recognize revenue net of GTN adjustments that are further described in "-Critical Accounting Policies."
The activities and ending reserve balances for each significant category of GTN adjustments were as follows:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dollars in millions
|
Charge-Backs and Cash Discounts
|
|
Medicaid and Medicare Rebates
|
|
Other Rebates, Returns, Discounts and Adjustments
|
|
Total
|
|
Balance at January 1, 2025
|
$
|
900
|
|
|
$
|
5,385
|
|
|
$
|
3,636
|
|
|
$
|
9,921
|
|
|
Provision related to sales made in:
|
|
|
|
|
|
|
|
|
Current period
|
14,069
|
|
|
18,351
|
|
|
9,394
|
|
|
41,814
|
|
|
Prior period
|
(2)
|
|
|
(342)
|
|
|
(141)
|
|
|
(485)
|
|
|
Payments and returns
|
(13,251)
|
|
|
(18,752)
|
|
|
(8,951)
|
|
|
(40,954)
|
|
|
Foreign currency translation and other
|
4
|
|
|
-
|
|
|
264
|
|
|
268
|
|
|
Balance at December 31, 2025
|
$
|
1,720
|
|
|
$
|
4,643
|
|
|
$
|
4,202
|
|
|
$
|
10,565
|
|
The reconciliation of gross product sales to net product sales by each significant category of GTN adjustments was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
Dollars in millions
|
2025
|
|
2024
|
|
% Change
|
|
Gross product sales
|
$
|
88,085
|
|
|
$
|
83,671
|
|
|
5
|
%
|
|
GTN Adjustments
|
|
|
|
|
|
|
Charge-backs and cash discounts
|
(14,067)
|
|
|
(11,510)
|
|
|
22
|
%
|
|
Medicaid and Medicare rebates
|
(18,010)
|
|
|
(16,551)
|
|
|
9
|
%
|
|
Other rebates, returns, discounts and adjustments
|
(9,253)
|
|
|
(8,832)
|
|
|
5
|
%
|
|
Total GTN Adjustments
|
(41,329)
|
|
|
(36,893)
|
|
|
12
|
%
|
|
Net product sales
|
$
|
46,756
|
|
|
$
|
46,778
|
|
|
-
|
%
|
|
|
|
|
|
|
|
|
GTN adjustments percentage
|
47
|
%
|
|
44
|
%
|
|
3
|
%
|
|
U.S.
|
53
|
%
|
|
49
|
%
|
|
4
|
%
|
|
Non-U.S.
|
19
|
%
|
|
20
|
%
|
|
(1)
|
%
|
Reductions/(increases) to provisions for product sales made in prior periods resulting from changes in estimates were $485 million for 2025 and $159 million for 2024. The reductions to provisions in 2025 primarily related to lower than expected Medicaid utilization, and the reductions to provisions in 2024 primarily related to the non-U.S. revisions in clawback amounts driven by VAT recoverable estimates. GTN adjustments are primarily a function of product sales volume, regional and payer channel mix, contractual or legislative discounts and rebates. U.S. GTN adjustments percentage increased primarily due to the redesign of the U.S. Medicare Part D program and higher government channel mix, which has higher GTN adjustment percentages.
Total Revenues by Product:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
Dollars in millions
|
2025
|
|
2024
|
|
% Change
|
|
Growth Portfolio
|
|
|
|
|
|
|
Opdivo
|
$
|
10,049
|
|
|
$
|
9,304
|
|
|
8
|
%
|
|
U.S.
|
5,904
|
|
|
5,350
|
|
|
10
|
%
|
|
Non-U.S.
|
4,145
|
|
|
3,954
|
|
|
5
|
%
|
|
|
|
|
|
|
|
|
Opdivo Qvantig
|
238
|
|
|
-
|
|
|
N/A
|
|
U.S.
|
205
|
|
|
-
|
|
|
N/A
|
|
Non-U.S.
|
33
|
|
|
-
|
|
|
N/A
|
|
|
|
|
|
|
|
|
Orencia
|
3,705
|
|
|
3,682
|
|
|
1
|
%
|
|
U.S.
|
2,736
|
|
|
2,770
|
|
|
(1)
|
%
|
|
Non-U.S.
|
969
|
|
|
912
|
|
|
6
|
%
|
|
|
|
|
|
|
|
|
Yervoy
|
2,900
|
|
|
2,530
|
|
|
15
|
%
|
|
U.S.
|
1,825
|
|
|
1,599
|
|
|
14
|
%
|
|
Non-U.S.
|
1,075
|
|
|
931
|
|
|
15
|
%
|
|
|
|
|
|
|
|
|
Reblozyl
|
2,327
|
|
|
1,773
|
|
|
31
|
%
|
|
U.S.
|
1,888
|
|
|
1,444
|
|
|
31
|
%
|
|
Non-U.S.
|
438
|
|
|
329
|
|
|
33
|
%
|
|
|
|
|
|
|
|
|
Breyanzi
|
1,358
|
|
|
747
|
|
|
82
|
%
|
|
U.S.
|
994
|
|
|
591
|
|
|
68
|
%
|
|
Non-U.S.
|
364
|
|
|
156
|
|
|
132
|
%
|
|
|
|
|
|
|
|
|
Opdualag
|
1,185
|
|
|
928
|
|
|
28
|
%
|
|
U.S.
|
1,045
|
|
|
870
|
|
|
20
|
%
|
|
Non-U.S.
|
140
|
|
|
58
|
|
|
139
|
%
|
|
|
|
|
|
|
|
|
Camzyos
|
1,068
|
|
|
602
|
|
|
77
|
%
|
|
U.S.
|
863
|
|
|
543
|
|
|
59
|
%
|
|
Non-U.S.
|
204
|
|
|
59
|
|
|
>200%
|
|
|
|
|
|
|
|
|
Zeposia
|
577
|
|
|
566
|
|
|
2
|
%
|
|
U.S.
|
392
|
|
|
403
|
|
|
(3)
|
%
|
|
Non-U.S.
|
186
|
|
|
163
|
|
|
14
|
%
|
|
|
|
|
|
|
|
|
Abecma
|
427
|
|
|
406
|
|
|
5
|
%
|
|
U.S.
|
208
|
|
|
242
|
|
|
(14)
|
%
|
|
Non-U.S.
|
219
|
|
|
164
|
|
|
34
|
%
|
|
|
|
|
|
|
|
|
Sotyktu
|
291
|
|
246
|
|
|
19
|
%
|
|
U.S.
|
182
|
|
190
|
|
|
(5)
|
%
|
|
Non-U.S.
|
110
|
|
56
|
|
|
99
|
%
|
|
|
|
|
|
|
|
|
Krazati
|
205
|
|
|
126
|
|
|
62
|
%
|
|
U.S.
|
192
|
|
|
118
|
|
|
63
|
%
|
|
Non-U.S.
|
13
|
|
|
8
|
|
|
60
|
%
|
|
|
|
|
|
|
|
|
Cobenfy
|
155
|
|
|
10
|
|
|
>200%
|
|
U.S.
|
155
|
|
|
10
|
|
|
>200%
|
|
Non-U.S.
|
-
|
|
|
-
|
|
|
N/A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
Dollars in millions
|
2025
|
|
2024
|
|
% Change
|
|
Growth Portfolio (cont.)
|
|
|
|
|
|
|
Other Growth Products(a)
|
1,924
|
|
|
1,643
|
|
|
17
|
%
|
|
U.S.
|
782
|
|
|
710
|
|
|
10
|
%
|
|
Non-U.S.
|
1,142
|
|
|
933
|
|
|
22
|
%
|
|
|
|
|
|
|
|
|
Total Growth Portfolio
|
$
|
26,409
|
|
|
$
|
22,563
|
|
|
17
|
%
|
|
U.S.
|
17,371
|
|
|
14,840
|
|
|
17
|
%
|
|
Non-U.S.
|
9,038
|
|
|
7,723
|
|
|
17
|
%
|
|
|
|
|
|
|
|
|
Legacy Portfolio
|
|
|
|
|
|
|
Eliquis
|
$
|
14,443
|
|
|
$
|
13,333
|
|
|
8
|
%
|
|
U.S.
|
10,239
|
|
|
9,631
|
|
|
6
|
%
|
|
Non-U.S.
|
4,205
|
|
|
3,702
|
|
|
14
|
%
|
|
|
|
|
|
|
|
|
Revlimid
|
2,951
|
|
|
5,773
|
|
|
(49)
|
%
|
|
U.S.
|
2,535
|
|
|
4,999
|
|
|
(49)
|
%
|
|
Non-U.S.
|
416
|
|
|
774
|
|
|
(46)
|
%
|
|
|
|
|
|
|
|
|
Pomalyst/Imnovid
|
2,733
|
|
|
3,545
|
|
|
(23)
|
%
|
|
U.S.
|
2,341
|
|
|
2,695
|
|
|
(13)
|
%
|
|
Non-U.S.
|
391
|
|
|
850
|
|
|
(54)
|
%
|
|
|
|
|
|
|
|
|
Sprycel
|
493
|
|
|
1,286
|
|
|
(62)
|
%
|
|
U.S.
|
299
|
|
|
983
|
|
|
(70)
|
%
|
|
Non-U.S.
|
194
|
|
|
303
|
|
|
(36)
|
%
|
|
|
|
|
|
|
|
|
Abraxane
|
368
|
|
|
875
|
|
|
(58)
|
%
|
|
U.S.
|
116
|
|
|
541
|
|
|
(78)
|
%
|
|
Non-U.S.
|
251
|
|
|
334
|
|
|
(25)
|
%
|
|
|
|
|
|
|
|
|
Other Legacy Products(b)
|
798
|
|
|
925
|
|
|
(14)
|
%
|
|
U.S.
|
378
|
|
|
416
|
|
|
(9)
|
%
|
|
Non-U.S.
|
420
|
|
|
509
|
|
|
(17)
|
%
|
|
|
|
|
|
|
|
|
Total Legacy Portfolio
|
$
|
21,785
|
|
|
$
|
25,737
|
|
|
(15)
|
%
|
|
U.S.
|
15,908
|
|
|
19,265
|
|
|
(17)
|
%
|
|
Non-U.S.
|
5,877
|
|
|
6,472
|
|
|
(9)
|
%
|
|
|
|
|
|
|
|
|
Total Revenues
|
$
|
48,194
|
|
|
$
|
48,300
|
|
|
-
|
%
|
|
U.S.
|
33,279
|
|
|
34,105
|
|
|
(2)
|
%
|
|
Non-U.S.(c)
|
14,915
|
|
|
14,195
|
|
|
5
|
%
|
(a) Includes Augtyro, Onureg, Inrebic, Nulojix, Emplicitiand royalty revenues, including royalties received from Merck on Winrevair*.
(b) Includes other mature brands.
(c) Includes international and other.
Growth Portfolio
Opdivo (nivolumab) - a fully human monoclonal antibody that binds to the PD-1 on T and NKT cells. It has been approved for several anti-cancer indications including bladder, blood, CRC, head and neck, RCC, HCC, lung, melanoma, MPM, stomach and esophageal cancer. The Opdivo+Yervoyregimen also is approved in multiple markets for the treatment of NSCLC, melanoma, MPM, RCC, CRC, HCC and various gastric and esophageal cancers.
•U.S. revenues increased 10% in 2025, primarily due to higher demand and higher average net selling prices.
•International revenues increased 5% in 2025, primarily due to higher demand for additional indication launches and foreign exchange impacts of 1%. Excluding foreign exchange impacts, revenues increased 4%.
Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) - a subcutaneously administered PD-1 inhibitor indicated for most previously approved adult, solid tumor Opdivoindications as monotherapy, monotherapy maintenance following completion of Opdivoplus Yervoycombination therapy, or in combination with chemotherapy or cabozantinib. Opdivo Qvantig was launched in the U.S. and Puerto Rico in January 2025. Additionally, in May 2025, the product was approved by the EC.
Orencia (abatacept) - a fusion protein indicated for (i) the treatment of adult patients with moderately to severely active RA, (ii) the treatment of patients 2 years of age and older with moderately to severely active polyarticular JIA, (iii) the treatment of patients 2 years of age and older with active PsA and (iv) the prophylaxis of aGVHD, in combination with a calcineurin inhibitor and methotrexate in certain adult and pediatric patients.
•U.S. revenues decreased 1% in 2025, primarily due to lower average net selling prices, partially offset by higher demand.
•International revenues increased 6% in 2025, primarily due to higher demand and foreign exchange impacts of 1%. Excluding foreign exchange impacts, revenues increased 5%.
•BMS is not aware of any Orenciabiosimilars on the market in the U.S., EU or Japan. Formulation and additional patents expire in 2026 and beyond.
Yervoy (ipilimumab) - a CTLA4 immune checkpoint inhibitor. Yervoyis a monoclonal antibody for the treatment of patients with unresectable or metastatic melanoma. The Opdivo+Yervoyregimen is approved in multiple markets for the treatment of NSCLC, melanoma, MPM, RCC, CRC, HCC and esophageal cancer.
•U.S. revenues increased 14% in 2025, primarily due to higher demand and higher average net selling prices.
•International revenues increased 15% in 2025, primarily due to higher demand and foreign exchange impacts of 2%. Excluding foreign exchange impacts, revenues increased 14%.
•BMS is not aware of a Yervoybiosimilar on the market in the U.S., EU, or Japan.
Reblozyl (luspatercept-aamt) - an erythroid maturation agent indicated for the treatment of anemia in (i) adult patients with transfusion dependent and non-transfusion dependent beta thalassemia who require regular red blood cell transfusions, (ii) adult patients with very low- to intermediate-risk MDS who have ring sideroblasts and require red blood cell transfusions, as well as (iii) adult patients without previous erythropoiesis stimulating agent use (ESA-naïve) with very low- to intermediate-risk MDS who may require regular red blood cell transfusions, regardless of RS status. Reblozylis the subject of a global licensing agreement pursuant to which we pay tiered royalties to Merck ranging from 20% to 24% of net sales, which are included in Cost of products sold. Refer to "Item 8. Financial Statements and Supplementary Data-Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements" for more information.
•U.S. revenues increased 31% in 2025, primarily due to higher demand.
•International revenues increased 33% in 2025, primarily due to higher demand and foreign exchange impacts of 3%. Excluding foreign exchange impacts, revenues increased 30%.
Breyanzi(lisocabtagene maraleucel) - a CD19-directed genetically modified autologous CAR-T cell therapy indicated for the treatment of adult patients with relapsed or refractory LBCL after one or more lines of systemic therapy, including DLBCL not otherwise specified, high-grade B-cell lymphoma, primary mediastinal LBCL, grade 3B FL and relapsed or refractory FL after at least two prior lines of systemic therapy, relapsed or refractory CLL or SLL; relapsed or refractory MCL in patients who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor; and relapsed or refractory MZL after at least two prior lines of systemic therapy.
•U.S. revenues increased 68% in 2025, primarily due to higher demand for core indications and additional indication launches.
•International revenues increased 132% in 2025, primarily due to higher demand driven by new indication launches and launches in new markets as well as foreign exchange impacts of 8%. Excluding foreign exchange impacts, revenues increased 124%.
Opdualag (nivolumab and relatlimab-rmbw) - a combination of nivolumab, a PD-1 blocking antibody, and relatlimab, a LAG-3 blocking antibody, indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.
•U.S. revenues increased 20% in 2025, primarily due to higher demand.
Camzyos (mavacamten) - an oral cardiac myosin inhibitor indicated for the treatment of adults with symptomatic oHCM to improve functional capacity and symptoms.
•U.S. revenues increased 59% in 2025, primarily due to higher demand.
•International revenues increased more than 200% in 2025, primarily due to higher demand driven by launches in new markets.
Zeposia(ozanimod) - an oral immunomodulatory drug used to treat relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults and to treat moderately to severely active UC in adults.
•U.S. revenues decreased 3% in 2025, primarily due to lower demand.
•International revenues increased 14% in 2025, primarily due to higher demand and foreign exchange impacts of 4%. Excluding foreign exchange impacts, revenues increased 10%.
Abecma(idecabtagene vicleucel) - is a BCMA genetically modified autologous CAR-T cell therapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-cyclic ADP ribose hydrolase monoclonal antibody.
•U.S. revenues decreased 14% in 2025, primarily due to lower demand from increased competition in BCMA targeted therapies.
•International revenues increased 34% in 2025, primarily due to a one-time favorable GTN adjustment in 2025 and foreign exchange impacts of 4%. Excluding foreign exchange impacts, revenues increased 29%.
Sotyktu(deucravacitinib) - an oral, selective, allosteric tyrosine kinase 2 inhibitor indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
•U.S. revenues decreased 5% in 2025, primarily due to lower average net selling prices, partially offset by higher demand.
•International revenues increased 99% in 2025, primarily due to higher demand and foreign exchange impacts of 3%. Excluding foreign exchange impacts, revenues increased 95%.
Krazati(adagrasib) - a highly selective and potent oral small-molecule inhibitor of the KRASG12C mutation, indicated for the treatment of adult patients with KRASG12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy and, in combination with cetuximab, for the treatment of adult patients with KRASG12C-mutated locally advanced or metastatic CRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. Krazatiwas brought into the BMS portfolio as part of the Mirati acquisition completed in 2024.
•U.S. revenues increased 63% in 2025, primarily due to higher demand.
Cobenfy (xanomeline and trospium chloride) - an oral combination of xanomeline, a M1/M4 muscarinic agonist, and trospium chloride, a peripheral muscarinic antagonist, indicated for the treatment of schizophrenia in adults. Cobenfy was approved by the FDA in September 2024 and launched in the U.S. in October 2024 and Puerto Rico in January 2025.
Other growth products - includes Augtyro, Onureg, Inrebic, Nulojix, Empliciti and royalty revenues.
Legacy Portfolio
Eliquis(apixaban) - an oral Factor Xa inhibitor indicated for the reduction in risk of stroke/systemic embolism in NVAF and for the treatment of DVT/PE and reduction in risk of recurrence following initial therapy.
•U.S. revenues increased 6% in 2025, primarily due to higher demand.
•International revenues increased 14% in 2025, primarily due to higher demand and foreign exchange impacts of 4%. Excluding foreign exchange impacts, revenues increased 9%.
•Following the May 2021 expiration of regulatory exclusivity for Eliquisin Europe, generic manufacturers have sought to challenge our Eliquispatents and related SPCs and have begun marketing generic versions of Eliquisin certain countries prior to the expiry of our patents and related SPCs, which has led to the filing of infringement and invalidity actions involving our Eliquispatents and related SPCs being filed in various countries in Europe. We believe in the innovative science behind Eliquisand the strength of our intellectual property, which we will defend against infringement. Refer to "Item 1. Financial Statements-Note 20. Legal Proceedings and Contingencies-Intellectual Property" for further information.
Revlimid (lenalidomide) - an oral immunomodulatory drug that in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma. Revlimidas a single agent is also indicated as a maintenance therapy in patients with multiple myeloma following autologous hematopoietic stem cell transplant. Revlimidhas received approvals for several indications in the hematological malignancies including lymphoma and MDS.
•U.S. revenues decreased 49% in 2025, primarily due to lower demand driven by generic erosion and lower average net selling prices. Lower average net selling prices were impacted by the redesign of the Medicare Part D program and government channel mix during 2025.
•International revenues decreased 46% in 2025, primarily due to lower demand driven by generic erosion.
•In the U.S., certain third parties have been granted volume-limited licenses to sell generic lenalidomide. Pursuant to these licenses, several generics have entered or are expected to enter the U.S. market with volume-limited quantities of generic lenalidomide. As of January 31, 2026, these licenses are no longer volume-limited. In the EU and Japan, generic lenalidomide products have entered the market.
Pomalyst/Imnovid (pomalidomide) - a proprietary, distinct, small molecule that is administered orally and modulates the immune system and other biologically important targets. Pomalyst/Imnovidis indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
•U.S. revenues decreased 13% in 2025, primarily due to lower average net selling prices, mainly driven by the redesign of the Medicare Part D program.
•International revenues decreased 54% in 2025, primarily due to lower demand driven by generic erosion.
•Generic pomalidomide products entered the EU market in August 2024 and are expected to enter the U.S. market in March 2026.
Sprycel (dasatinib) - an oral inhibitor of multiple tyrosine kinase indicated for the first-line treatment of patients with Philadelphia chromosome-positive CML in chronic phase and the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase CML with resistance or intolerance to prior therapy, including Gleevec* (imatinib mesylate) and the treatment of children and adolescents aged 1 year to 18 years with chronic phase Philadelphia chromosome-positive CML.
•U.S. revenues decreased 70% in 2025, primarily due to lower demand driven by generic erosion.
•International revenues decreased 36% in 2025, primarily due to lower demand driven by generic erosion and foreign exchange impacts of (1)%. Excluding foreign exchange impact, revenues decreased 35%.
•In the U.S. (September 2024), EU and Japan, generic dasatinib products have entered the market.
Abraxane (paclitaxel albumin-bound particles for injectable suspension) - a solvent-free protein-bound chemotherapy product that combines paclitaxel with albumin using our proprietary Nab®technology platform, and is used to treat breast cancer, NSCLC and pancreatic cancer, among others.
•U.S. revenues decreased 78% in 2025, primarily due to lower demand driven by generic erosion.
Other legacy products - includes other mature brands.
Estimated End-User Demand
Pursuant to the SEC Consent Order described under "-SEC Consent Order", we monitor inventory levels on hand in the U.S. wholesaler distribution channel and outside of the U.S. in the direct customer distribution channel. We disclose products with levels of inventory in excess of one month on hand or expected demand, subject to certain limited exceptions. There were none as of December 31, 2025, for our U.S. distribution channels, and September 30, 2025, for our non-U.S. distribution channels.
In the U.S., we generally determine our months on hand estimates using inventory levels of product on hand and the amount of out-movement provided by our three largest wholesalers, which account for approximately 87% of total gross sales of U.S. products for the year ended December 31, 2025. Factors that may influence our estimates include generic erosion, seasonality of products, wholesaler purchases in light of increases in wholesaler list prices, new product launches, new warehouse openings by wholesalers and new customer stockings by wholesalers. In addition, these estimates are calculated using third-party data, which may be impacted by their recordkeeping processes.
Camzyosis only available through a restricted program called the CamzyosREMS Program. Product distribution is limited to REMS certified pharmacies, and enrolled pharmacies must only dispense to patients who are authorized to receive Camzyos. Revlimid and Pomalystare distributed in the U.S. primarily through contracted pharmacies under the Lenalidomide REMS and PomalystREMS programs, respectively. These are proprietary risk-management distribution programs tailored specifically to provide for the safe and appropriate distribution and use of Revlimid and Pomalyst. Internationally, Revlimid and Imnovidare distributed under mandatory risk-management distribution programs tailored to meet local authorities' specifications to provide for the products' safe and appropriate distribution and use. These programs may vary by country and, depending upon the country and the design of the risk-management program, the product may be sold through hospitals or retail pharmacies.
Our non-U.S. businesses have significantly more direct customers. Information on available direct customer product level inventory and corresponding out-movement information and the reliability of third-party demand information varies widely. We limit our direct customer sales channel inventory reporting to where we can influence demand. When this information does not exist or is otherwise not available, we have developed a variety of methodologies to estimate such data, including using historical sales made to direct customers and third-party market research data related to prescription trends and end-user demand. Given the difficulties inherent in estimating third-party demand information, we evaluate our methodologies to estimate direct customer product level inventory and to calculate months on hand on an ongoing basis and make changes as necessary. Factors that may affect our estimates include generic competition, seasonality of products, price increases, new product launches, new warehouse openings by direct customers, new customer stockings by direct customers and expected direct customer purchases for governmental bidding situations. As such, all of the information required to estimate months on hand in the direct customer distribution channel for non-U.S. business for the year ended December 31, 2025 is not available prior to the filing of this 2025 Form 10-K. We will disclose any product with levels of inventory in excess of one month on hand or expected demand for the current quarter, subject to certain limited exceptions, in our next quarterly report on Form 10-Q.
Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
Dollar in Millions
|
2025
|
|
2024
|
|
% Change
|
|
Cost of products sold (a)
|
$
|
13,936
|
|
|
$
|
13,968
|
|
|
-
|
%
|
|
Selling, general and administrative
|
7,267
|
|
|
8,414
|
|
|
(14)
|
%
|
|
Research and development
|
9,951
|
|
|
11,159
|
|
|
(11)
|
%
|
|
Acquired IPRD
|
3,721
|
|
|
13,373
|
|
|
(72)
|
%
|
|
Amortization of acquired intangible assets
|
3,317
|
|
|
8,872
|
|
|
(63)
|
%
|
|
Other (income)/expense, net
|
674
|
|
|
893
|
|
|
(24)
|
%
|
|
Total Expenses
|
$
|
38,866
|
|
|
$
|
56,679
|
|
|
(31)
|
%
|
(a) Excludes amortization of acquired intangible assets.
Cost of products sold
Cost of products sold include material, internal labor and overhead costs from our owned manufacturing sites, third-party product supply costs and other supply chain costs managed by our global manufacturing and supply organization. Cost of products sold also includes royalties and profit sharing, foreign currency hedge settlement gains and losses and impairment charges, as well as proportionate allocations of enterprise-wide costs. The allocations include facilities, information technology and other appropriate costs. Cost of products sold excludes amortization from acquired intangible assets.
Cost of products sold was relatively flat, reflecting lower intangible asset impairment charges ($1.3 billion), offset by higher alliance profit sharing and product mix.
Selling, general and administrative
Selling, general and administrative expenses primarily include salary and benefit costs, third-party professional and marketing fees, outsourcing fees, shipping and handling costs, advertising and product promotion costs, as well as proportionate allocations of enterprise-wide costs. The allocations include facilities, information technology, and other appropriate costs. Expenses are managed through regional commercialization organizations or global enabling functions such as finance, legal, information technology and human resources. Certain expenses are shared with alliance partners based upon contractual agreements.
Selling, general and administrative expenses decreased by $1.1 billion or 14%, primarily due to cost savings from the Company's ongoing strategic productivity initiative and lower acquisition-related cash settlements of unvested stock awards, partially offset by higher investments in new product launches.
Research and development
Research and development activities include (i) research, which includes discovery and development of new molecular entities through pre-clinical studies, (ii) drug development, which includes clinical development of potential new products, including expansion of indications for existing products through Phase I, Phase II and Phase III clinical studies and (iii) other related charges including support of manufacturing development of pre-approved products, medical support for marketed products, IPRD impairment charges, acquisition related charges and proportionate allocations of enterprise-wide costs. The allocations include facilities, information technology, and other appropriate costs. Certain expenses are shared with alliance partners based upon contractual agreements.
Research and development expense decreased by $1.2 billion or 11%, primarily due to lower IPRD impairment charges, cost savings from the Company's ongoing strategic productivity initiative and lower acquisition-related cash settlements of unvested stock awards.
Acquired IPRD
Acquired IPRD expenses are comprised of upfront payments, contingent milestone payments in connection with asset acquisitions or in-license arrangements of third-party intellectual property rights, as well as any upfront and contingent milestones payable by BMS to alliance partners prior to regulatory approval. Acquired IPRD charges are detailed in the table below.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
Dollars in millions
|
2025
|
|
2024
|
|
Karuna asset acquisition (Note 4)
|
$
|
-
|
|
|
$
|
12,122
|
|
|
BioNTech upfront fee (Note 3)
|
1,500
|
|
|
-
|
|
|
Orbital asset acquisition (Note 4)
|
1,379
|
|
|
-
|
|
|
Philochem upfront fee (Note 4)
|
350
|
|
|
-
|
|
|
SystImmune upfront fee and milestone (Note 3)
|
250
|
|
|
800
|
|
|
BioArctic upfront fee (Note 4)
|
100
|
|
|
-
|
|
|
Evotec designation and opt-in license fees
|
113
|
|
|
170
|
|
|
RayzeBio rights buy-out
|
-
|
|
|
92
|
|
|
Prothena opt-in license fee
|
-
|
|
|
80
|
|
|
Other
|
29
|
|
|
109
|
|
|
Acquired IPRD
|
$
|
3,721
|
|
|
$
|
13,373
|
|
Refer to "Item 8. Financial Statements and Supplementary Data-Note 3. Alliances" and "-Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements" for additional information.
Amortization of Acquired Intangible Assets
Amortization of acquired intangible assets decreased by $5.6 billion or 63% primarily due to the lower amortization expense related to Revlimid. The Revlimidacquired marketed product right was fully amortized in the fourth quarter of 2024. Additionally, the Pomalystacquired marketed product right was fully amortized in the fourth quarter of 2025.
Other (income)/expense, net
Other (income)/expense, net changed by $219 million as discussed below.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
Dollars in millions
|
2025
|
|
2024
|
|
Interest expense
|
$
|
1,891
|
|
|
$
|
1,947
|
|
|
Royalty income - divestitures
|
(1,129)
|
|
|
(1,104)
|
|
|
Royalty and licensing income
|
(1,093)
|
|
|
(736)
|
|
|
Investment income
|
(586)
|
|
|
(478)
|
|
|
Provision for restructuring
|
563
|
|
|
635
|
|
|
Litigation and other settlements
|
434
|
|
|
84
|
|
|
Loss on debt redemption
|
356
|
|
|
-
|
|
|
Contingent consideration
|
351
|
|
|
-
|
|
|
Equity investment (gains)/losses, net
|
(280)
|
|
|
(16)
|
|
|
Integration expenses
|
147
|
|
|
284
|
|
|
Acquisition expense
|
9
|
|
|
50
|
|
|
Other
|
11
|
|
|
227
|
|
|
Other (income)/expense, net
|
$
|
674
|
|
|
$
|
893
|
|
•As part of its diabetes termination agreement with AstraZeneca, BMS received royalty payments based on net sales, which terminated as of December 31, 2025.
•Royalties and licensing income in 2025 includes (i) $85 million of income recognized in connection with the out-license of five early-stage immunology assets to a company that was newly-formed with Bain Capital Life Sciences and (ii) $170 million of income related to the amendment of a pre-existing out-licensing arrangement, which effectively terminates future royalties BMS
would have been entitled to earn on international sales. Refer to "Item 8. Financial Statements and Supplementary Data-Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements" for more information.
•Investment income increased in 2025 due to higher cash balances.
•Provision for restructuring includes exit and other costs primarily related to certain restructuring activities including plans discussed further in "Item 8. Financial Statements and Supplementary Data-Note 6. Restructuring."
•Litigation and other settlements includes amounts related to a pricing, sales and promotional practices dispute and a securities litigation matter in 2025. Refer to "Item 8. Financial Statements and Supplementary Data-Note 20. Legal Proceedings and Contingencies" for more information.
•Loss on debt redemption resulted from the early redemption of $8.7 billion long-term debt obligations in 2025. Refer to "Item 8. Financial Statements and Supplementary Data-Note 10. Financing Arrangements" for more information.
•Contingent consideration in 2025 reflects the change in fair value of the contingent value rights associated with the Mirati acquisition. Refer to "Item 8. Financial Statements and Supplementary Data-Note 9. Financial Instruments and Fair Value Measurements" for more information.
•Equity investments generated higher gains in 2025, primarily driven by fair value adjustments for investments that have readily determinable fair value. Refer to "Item 8. Financial Statements and Supplementary Data-Note 9. Financial Instruments and Fair Value Measurements" for more information.
•Integration expenses include initiatives to realize expected cost synergies from acquisitions. Refer to "Item 8. Financial Statements and Supplementary Data-Note 6. Restructuring" for more information.
•Other in 2024 includes pension settlement charges of $119 million, related to the termination of the Bristol-Myers Squibb Puerto Rico, Inc. Retirement Income pension plan.
Income Taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
Dollars in millions
|
2025
|
|
2024
|
|
Earnings/(Loss) before income taxes
|
$
|
9,328
|
|
|
$
|
(8,379)
|
|
|
Income tax provision
|
2,272
|
|
|
554
|
|
|
Effective tax rate
|
24.4
|
%
|
|
(6.6)
|
%
|
|
|
|
|
|
|
Impact of specified items
|
(5.6)
|
%
|
|
63.4
|
%
|
|
Effective tax rate excluding specified items
|
18.8
|
%
|
|
56.8
|
%
|
In July 2025, the U.S. enacted into law new tax legislation, the OBBBA, which among other measures, makes permanent many provisions of the TCJA and modifies certain rules, including within the international tax framework. The OBBBA permits businesses to immediately deduct up to 100% of their qualifying domestic R&D expenses in the year they are incurred for tax years beginning after December 31, 2024, and allows businesses to accelerate deductions (over a one- or two-year period) of domestic R&D expenses that were deferred from 2022 to 2024. The tax impacts from the OBBBA are reflected in the Company's income tax provision for 2025 and in the tax asset and liability balances recorded as of December 31, 2025.
The effective tax rate for 2025 was primarily impacted by a $1.4 billion one-time, non-tax deductible charge for the acquisition of Orbital Therapeutics and jurisdictional earnings mix. Additionally, the effective tax rate includes the impacts of (i) the release of approximately $300 million of income tax reserves related to the lapse of statute for the U.S. federal years 2019-2020, offset by (ii) the addition of income tax reserves for certain transfer pricing ($160 million) and other matters. Excluding the impact of specified items, the effective tax rate was impacted by the aforementioned Orbital Therapeutics acquisition, jurisdictional earnings mix and reserve release for the U.S. federal years 2019-2020.
The effective tax rate for 2024 was primarily impacted by (i) a $12.1 billion one-time, non-tax deductible charge for the acquisition of Karuna, (ii) jurisdictional earnings mix, including amortization of acquired intangible assets, (iii) impacts of impairments of intangible assets, and (iv) a release of income tax reserves of $644 million related to the resolution of Celgene's 2017-2019 IRS audit. Excluding the impact of specified items, the effective tax rate was impacted by the aforementioned Karuna non-tax deductible charge and jurisdictional earnings mix.
Refer to "Item 8. Financial Statements and Supplementary Data-Note 7. Income Taxes" for additional information.
Non-GAAP Financial Measures
Our 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. These items are adjusted 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 (i) 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, (ii) unwinding of inventory purchase price adjustments, (iii) acquisition and integration expenses, (iv) restructuring costs, (v) accelerated depreciation and impairment of property, plant and equipment and intangible assets, (vi) divestiture gains or losses, (vii) stock compensation resulting from acquisition-related equity awards, (viii) pension, legal and other contractual settlement charges, (ix) equity investment and contingent value rights fair value adjustments (including fair value adjustments attributed to limited partnerships and other investments), (x) loss on debt redemptions, and (xi) 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, as well as certain other significant tax items are also excluded such as the release of income tax reserves relating to the Celgene acquisition. We also provide international revenues for our priority products excluding the impact of foreign exchange. 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. Reconciliations of these non-GAAP financial measures to the most comparable GAAP measures are included in Exhibit 99.1 to our Form 8-K filed on February 5, 2026 and are incorporated herein by reference.
Non-GAAP information is intended to portray the results of our baseline performance, supplement or enhance management's, analysts' and investors' overall understanding of our underlying financial performance and facilitate comparisons among current, past and future periods. This information is not intended to be considered in isolation or as a substitute for the related financial measures 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.
Specified items were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
Dollars in millions
|
2025
|
|
2024
|
|
|
|
|
|
|
Inventory purchase price accounting adjustments
|
$
|
51
|
|
|
$
|
47
|
|
|
Intangible asset impairment
|
564
|
|
|
1,839
|
|
|
Site exit and other costs
|
127
|
|
|
133
|
|
|
Cost of products sold
|
742
|
|
|
2,019
|
|
|
|
|
|
|
|
Acquisition related charges(a)
|
75
|
|
|
372
|
|
|
Site exit and other costs
|
43
|
|
|
50
|
|
|
Selling, general and administrative
|
118
|
|
|
422
|
|
|
|
|
|
|
|
IPRD impairments
|
385
|
|
|
980
|
|
|
Acquisition related charges(a)
|
18
|
|
|
348
|
|
|
Site exit and other costs
|
56
|
|
|
49
|
|
|
Research and development
|
459
|
|
|
1,377
|
|
|
|
|
|
|
|
Amortization of acquired intangible assets
|
3,317
|
|
|
8,872
|
|
|
|
|
|
|
|
Interest expense
|
(68)
|
|
|
(49)
|
|
|
Provision for restructuring
|
563
|
|
|
635
|
|
|
Litigation and other settlements
|
432
|
|
|
61
|
|
|
Loss on debt redemption
|
356
|
|
|
-
|
|
|
Contingent consideration
|
351
|
|
|
-
|
|
|
Equity investment (gains)/losses
|
(283)
|
|
|
(18)
|
|
|
Integration expenses
|
147
|
|
|
284
|
|
|
Acquisition expenses
|
9
|
|
|
50
|
|
|
Other
|
(18)
|
|
|
182
|
|
Other (income)/expense, net
|
1,488
|
|
|
1,145
|
|
|
|
|
|
|
|
Increase to earnings/(loss) before income taxes
|
6,124
|
|
|
13,835
|
|
|
|
|
|
|
|
Income taxes on items above
|
(732)
|
|
|
(2,045)
|
|
|
Specified tax charge/(benefit)(b)
|
99
|
|
|
(502)
|
|
|
Income taxes
|
(633)
|
|
|
(2,547)
|
|
|
|
|
|
|
|
Increase to net earnings/(loss) attributable to BMS
|
$
|
5,491
|
|
|
$
|
11,288
|
|
(a) Includes cash settlement of unvested stock awards, and other related costs incurred in connection with the recent acquisitions.
(b) Includes changes to tax reserves during 2025 related to certain matters under IRS audit and the release of tax reserves related to the resolution of the Celgene 2017-2019 IRS audit in 2024.
The reconciliations from GAAP to Non-GAAP were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
Dollars in millions, except per share data
|
2025
|
|
2024
|
|
Net earnings/(loss) attributable to BMS
|
|
|
|
|
GAAP
|
$
|
7,054
|
|
|
$
|
(8,948)
|
|
|
Specified Items
|
5,491
|
|
|
11,288
|
|
|
Non-GAAP
|
$
|
12,545
|
|
|
$
|
2,340
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding - diluted - GAAP
|
2,039
|
|
|
2,027
|
|
|
Incremental shares attributable to share-based compensation plans
|
-
|
|
|
5
|
|
|
Weighted-average common shares outstanding - diluted - Non-GAAP
|
2,039
|
|
|
2,032
|
|
|
|
|
|
|
|
Diluted earnings/(loss) per share attributable to BMS
|
|
|
|
|
GAAP
|
$
|
3.46
|
|
|
$
|
(4.41)
|
|
|
Specified items
|
2.69
|
|
|
5.56
|
|
|
Non-GAAP
|
$
|
6.15
|
|
|
$
|
1.15
|
|
Financial Position, Liquidity and Capital Resources
Our net debt position was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
Dollars in millions
|
2025
|
|
2024
|
|
Cash and cash equivalents
|
$
|
10,209
|
|
|
$
|
10,346
|
|
|
Marketable debt securities - current
|
464
|
|
|
513
|
|
|
Marketable debt securities - non-current
|
396
|
|
|
320
|
|
|
Total cash, cash equivalents and marketable debt securities
|
11,069
|
|
|
11,179
|
|
|
Short-term debt obligations
|
(2,261)
|
|
|
(2,046)
|
|
|
Long-term debt
|
(42,850)
|
|
|
(47,603)
|
|
|
Net debt position
|
$
|
(34,043)
|
|
|
$
|
(38,470)
|
|
Liquidity and Capital Resources
We regularly assess our anticipated working capital needs, debt and leverage ratio levels, debt maturities, capital expenditure requirements, dividend payouts, potential share repurchases and future investments or acquisitions in order to maximize shareholder return, efficiently finance our ongoing operations and maintain flexibility for future strategic transactions. We also regularly evaluate our capital structure to ensure financial risks, adequate liquidity access and lower cost of capital are efficiently managed, which may lead to the issuance of additional debt securities, the repurchase of debt securities prior to maturity or the issuance or repurchase of common stock.
We believe that our existing cash, cash equivalents and marketable debt securities together with our ability to generate cash from operations and our access to short-term and long-term borrowings are sufficient to satisfy our existing and anticipated cash needs for at least the next few years, including dividends, capital expenditures, milestone payments, working capital, income taxes, restructuring initiatives, business development, business combinations, asset acquisitions, repurchase of common stock, and debt maturities of approximately $8.9 billion through 2030, as well as any debt repurchases through redemptions or tender offers. During 2025, our net debt position decreased by $4.4 billion, primarily driven by cash provided by operations of $14.2 billion, partially offset by dividend payments of $5.0 billion and payments for recent acquisitions, collaborations and milestones of $3.9 billion.
In November 2025, BMS Ireland Capital Funding Designated Activity Company, a wholly-owned subsidiary of Bristol-Myers Squibb, completed a registered public offering of €5.0 billion in aggregate principal amount of euro-denominated senior unsecured notes ("2025 Senior Unsecured Notes"), with proceeds, net of loan issuance costs, of $5.7 billion. The notes are fully and unconditionally guaranteed on a senior unsecured basis by Bristol-Myers Squibb. Refer to "Item 8. Financial Statements and Supplementary Data-Note 10. Financing Arrangements" for additional information.
In November and December 2025, we repurchased certain debt obligations of $8.7 billion in aggregate principal amount for $9.1 billion of cash in a series of tender offers and "make whole" redemptions. In connection with these transactions, a $356 million loss on debt redemption was recognized based on the carrying value of the debt, which was included in Other (income)/expense, net.
In 2024, we issued the 2024 Senior Unsecured Notes in an aggregate principal amount of $13.0 billion with proceeds, net of discount and loan issuance costs, of $12.9 billion. The proceeds from the 2024 Senior Unsecured Notes were used to partially fund the acquisitions of RayzeBio and Karuna, and the remaining net proceeds were used for general corporate purposes. In connection with the issuance of the 2024 Senior Unsecured Notes, we terminated the $10.0 billion 364-day senior unsecured delayed draw term loan facility entered in February 2024 to provide bridge financing for the RayzeBio and Karuna acquisitions.
Repayment of notes at maturity aggregated approximately $1.9 billion in 2025 and $2.9 billion in 2024.
We have a share repurchase program, authorized by our Board of Directors, allowing for repurchases of BMS common stock shares, effected in the open market or through privately negotiated transactions in compliance with Rule 10b-18 under the Exchange Act, including through Rule 10b5-1 trading plans. The share repurchase program does not obligate us to repurchase any specific number of shares nor does it have a specific expiration date and may be suspended or discontinued at any time. The remaining share repurchase capacity under the BMS share repurchase program was $5.0 billion as of December 31, 2025. There were no share repurchases in 2025. Refer to "Item 8. Financial Statements and Supplementary Data-Note 17. Equity" for additional information.
Dividend payments were $5.0 billion in 2025 and $4.9 billion in 2024. Dividend paid per common share was $0.62 during each quarter of 2025. Dividends are authorized on a quarterly basis by our Board of Directors.
As of December 31, 2025, we had a five-year $5.0 billion revolving credit facility expiring in January 2030, extendable annually by one year with the consent of the lenders. In January 2026, we extended the credit facility to January 2031. In February 2024, BMS entered into a $2.0 billion 364-day revolving credit facility, which expired in January 2025. The facilities provide for customary terms and conditions with no financial covenants and are used to provide backup liquidity for our commercial paper borrowings. No borrowings were outstanding under the revolving credit facilities as of December 31, 2025 or 2024.
Under our commercial paper program, we may issue a maximum of $5.0 billion of unsecured notes with maturities of not more than 365 days from the date of issuance. The maximum issuance amount was reduced from $7.0 billion as of December 31, 2024 to $5.0 billion in January 2025. During 2024, we issued and repaid $3.0 billion of commercial paper under the program.
Our investment portfolio includes marketable debt securities, which are subject to changes in fair value as a result of interest rate fluctuations and other market factors. Our investment policy establishes limits on the amount and time to maturity of investments with any institution. The policy also requires that investments are only entered into with corporate and financial institutions that meet high credit quality standards. Refer to "Item 8. Financial Statements and Supplementary Data-Note 9. Financial Instruments and Fair Value Measurements" for further information.
Capital Expenditures
Annual capital expenditures were approximately $1.3 billion in 2025, $1.2 billion in 2024 and $1.1 billion in 2023 and are expected to be approximately $1.3 billion in 2026. We continue to make capital expenditures in connection with the expansion of our cell therapy and other manufacturing capabilities, research and development and other facility-related activities. Over the next three years we plan to make certain investments to improve and enable additional U.S. domestic manufacturing capabilities, a portion of which will include capital expenditures.
Contractual Obligations and Off-Balance Sheet Arrangements
In the normal course of business, we enter into contracts and commitments that obligate us to make payments in the future. Information regarding our obligations relating to debt, income taxes and lease arrangements are provided in "Item 8. Financial Statements and Supplementary Data-Note 1. Accounting Policies and Recently Issued Accounting Standards", "-Note 10. Financing Arrangements", "-Note 7. Income Taxes" and "-Note 14. Leases", respectively.
We are committed to an aggregate $18.3 billion of potential contingent future research and development milestone payments to third parties for in-licensing, asset acquisitions and development programs including early-stage milestones of $9.6 billion (milestones achieved through Phase III clinical studies) and late-stage milestones of $8.7 billion (milestones achieved post Phase III clinical studies). Payments generally are due and payable only upon achievement of certain developmental and regulatory milestones for which the specific timing cannot be predicted. Certain agreements also provide for sales-based milestones aggregating to $21.5 billion that we would be obligated to pay upon achievement of certain sales levels in addition to royalties. We also have certain manufacturing, development and commercialization obligations in connection with alliance arrangements. It is not practicable to estimate the amount of these obligations. Refer to "Item 8. Financial Statements and Supplementary Data-Note 3. Alliances" and "-Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements" for further information.
We do not have any off-balance sheet arrangements that are material or reasonably likely to become material to our financial condition or results of operations.
Credit Ratings
Our current long-term and short-term credit ratings assigned by Moody's Investors Service are A2 and Prime-1, respectively, with a stable long-term credit outlook. Our current long-term and short-term credit ratings assigned by Standard & Poor's are A and A-1, respectively, with a stable long-term credit outlook. The long-term ratings reflect the agencies' opinion that we have a low default risk but are somewhat susceptible to adverse effects of changes in circumstances and economic conditions. The short-term ratings reflect the agencies' opinion that we have good to extremely strong capacity for timely repayment. Any credit rating downgrade may affect the interest rate of any debt we may incur, the fair market value of existing debt and our ability to access the capital markets generally.
Cash Flows
The following is a discussion of cash flow activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
Dollars in millions
|
2025
|
|
2024
|
|
Cash flow provided by/(used in):
|
|
|
|
|
Operating activities
|
$
|
14,156
|
|
|
$
|
15,190
|
|
|
Investing activities
|
(4,132)
|
|
|
(21,352)
|
|
|
Financing activities
|
(10,348)
|
|
|
5,127
|
|
Operating Activities
Cash flow from operating activities represents the cash receipts and disbursements from all of our activities other than investing and financing activities. Operating cash flow is derived by adjusting net earnings for noncontrolling interest, non-cash operating items, gains and losses attributed to investing and financing activities and changes in operating assets and liabilities resulting from timing differences between the receipts and payments of cash and when the transactions are recognized in our results of operations. As a result, changes in cash from operating activities reflect the timing of cash collections from customers and alliance partners; payments to suppliers, alliance partners and employees; customer discounts and rebates; and tax payments in the ordinary course of business.
The $1.0 billion decrease in cash flow provided by operating activities compared to 2024 was primarily driven by higher GTN payments, partially offset by lower expenses due to the ongoing strategic productivity initiative and lower acquisition-related expenses, including the cash settlement of unvested stock awards.
Investing Activities
Cash requirements from investing activities include cash used for acquisitions, manufacturing and facility-related capital expenditures and purchases of marketable securities with original maturities greater than 90 days at the time of purchase, proceeds from business divestitures (including royalties), the sale and maturity of marketable securities, sale of equity investments, as well as upfront and contingent milestones payments from licensing arrangements.
The $17.2 billion change in cash flow used in investing activities compared to 2024 was due to higher acquisition-related payments of $17.9 billion in 2024, partially offset by lower net proceeds from marketable debt securities and equity investments of $566 million in 2025.
Financing Activities
Cash requirements from financing activities include cash used to pay dividends, repurchase common stock and repay long-term debt and other borrowings, as well as proceeds from the exercise of stock options and issuance of long-term debt and other borrowings.
The $15.5 billion change in cash provided by/(used in) financing activities compared to 2024 was primarily due to the issuance of long-term debt in 2024 to partially fund the acquisitions of RayzeBio and Karuna and the repurchases of debt in 2025, partially offset by new debt issuances in 2025. Refer to "Item 8. Financial Statements and Supplementary Data -Note 10. Financing Arrangements" for more information.
Recently Issued Accounting Standards
For recently issued accounting standards, refer to "Item 8. Financial Statements and Supplementary Data-Note 1. Accounting Policies and Recently Issued Accounting Standards."
SEC Consent Order
As previously disclosed, on August 4, 2004, we entered into a final settlement with the SEC, concluding an investigation concerning certain wholesaler inventory and accounting matters. The settlement was reached through a Consent, a copy of which was attached as Exhibit 10 to our quarterly report on Form 10-Q for the period ended September 30, 2004.
Under the terms of the Consent, we agreed, subject to certain defined exceptions, to limit sales of all products sold to our direct customers (including wholesalers, distributors, hospitals, retail outlets, pharmacies and government purchasers) based on expected demand or on amounts that do not exceed approximately one month of inventory on hand, without making a timely public disclosure of any change in practice. We also agreed in the Consent to certain measures that we have implemented including: (a) establishing a formal review and certification process of our annual and quarterly reports filed with the SEC; (b) establishing a business risk and disclosure group; (c) retaining an outside consultant to comprehensively study and help re-engineer our accounting and financial reporting processes; (d) publicly disclosing any sales incentives offered to direct customers for the purpose of inducing them to purchase products in excess of expected demand; and (e) ensuring that our budget process gives appropriate weight to inputs that come from the bottom to the top, and not just from the top to the bottom, and adequately documenting that process.
We have established a company-wide policy concerning our sales to direct customers for the purpose of complying with the Consent, which includes the adoption of various procedures to monitor and limit sales to direct customers in accordance with the terms of the Consent. These procedures include a governance process to escalate to appropriate management levels potential questions or concerns regarding compliance with the policy and timely resolution of such questions or concerns. In addition, compliance with the policy is monitored on a regular basis.
We maintain DSAs with our U.S. pharmaceutical wholesalers and specialty distributors, which account for approximately 97% of our gross U.S. revenues. Under the current terms of the DSAs, our wholesaler customers provide us with weekly information with respect to months on hand product-level inventories and the amount of out-movement of products. The three largest wholesalers currently account for approximately 87% of our gross U.S. revenues. The inventory information received from our wholesalers, together with our internal information, is used to estimate months on hand product level inventories at these wholesalers. We estimate months on hand product inventory levels for our U.S. business's wholesaler customers other than the three largest wholesalers by extrapolating from the months on hand calculated for the three largest wholesalers. In contrast, our non-U.S. business has significantly more direct customers, limited information on direct customer product level inventory and corresponding out-movement information and the reliability of third-party demand information, where available, varies widely. Accordingly, we rely on a variety of methods to estimate months on hand product level inventories for these business units.
We believe the above-described procedures provide a reasonable basis to ensure compliance with the Consent.
Critical Accounting Policies
The preparation of financial statements requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenue and expenses. Our critical accounting policies are those that significantly affect our financial condition and results of operations and require the most difficult, subjective or complex judgments, often because of the need to make estimates about the effect of matters that are inherently uncertain. Because of this uncertainty, actual results may vary from these estimates.
Revenue Recognition
Our accounting policy for revenue recognition has a substantial impact on reported results and relies on certain estimates. Revenue is recognized following a five-step model: (i) identify the customer contract; (ii) identify the contract's performance obligation; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation; and (v) recognize revenue when or as a performance obligation is satisfied. Revenue is also reduced for GTN sales adjustments discussed below, all of which involve significant estimates and judgment after considering legal interpretations of applicable laws and regulations, historical experience, payer channel mix (e.g. Medicare or Medicaid), current contract prices under applicable programs, unbilled claims and processing time lags and inventory levels in the distribution channel. Estimates are assessed each period and adjusted as required to revise information or actual experience.
The following categories of GTN adjustments involve significant estimates, judgments and information obtained from external sources. Refer to "Item 8. Financial Statements and Supplementary Data-Note 2. Revenue" for further discussion and analysis of each significant category of GTN sales adjustments.
Charge-backs and cash discounts
Our U.S. business participates in programs with government entities, the most significant of which are the U.S. Department of Defense and the U.S. Department of Veterans Affairs, and other parties, including covered entities under the 340B program, whereby pricing on products is extended below wholesaler list price to participating entities. These entities purchase products through wholesalers at the lower program price and the wholesalers then charge us the difference between their acquisition cost and the lower program price. Accounts receivable is reduced for the estimated amount of unprocessed charge-back claims attributable to a sale (typically within a two to four week time lag).
In the U.S. and some other countries, customers are offered cash discounts as an incentive for prompt payment on certain products, approximating 2% of the invoiced sales price. Accounts receivable is reduced for the estimated amount of cash discount at the time of sale and the discount is typically taken by the customer within one month.
Medicaid and Medicare rebates
Our U.S. business participates in state government Medicaid programs and other qualifying Federal and state government programs requiring discounts and rebates to participating state and local government entities. All discounts and rebates provided through these programs are included in our Medicaid rebate accrual. Medicaid rebates have also been extended to drugs used in managed Medicaid plans. The estimated amount of unpaid or unbilled rebates is presented as a liability.
Rebates and discounts are offered to managed healthcare organizations in the U.S. managing prescription drug programs and Medicare Advantage prescription drug plans covering the Medicare Part D drug benefit. As a result of the redesign of the U.S. Medicare Part D program, beginning in 2025, we paid 10% of costs up to a $2,000 cap for out-of-pocket costs for Medicare beneficiaries and 20% of costs after that cap was reached. The estimated amount of unpaid or unbilled rebates and discounts is presented as a liability.
Other rebates, returns, discounts and adjustments
Other GTN sales adjustments include sales returns and all other programs based on applicable laws and regulations for individual non-U.S. countries as well as rebates offered to managed healthcare organizations in the U.S. to a lesser extent. The non-U.S. programs include several different pricing schemes such as cost caps, volume discounts, outcome-based pricing schemes and pricing claw-backs that are based on sales of individual companies or an aggregation of all companies participating in a specific market. The estimated amount of unpaid or unbilled rebates and discounts is presented as a liability.
Estimated returns for established products are determined after considering historical experience and other factors including levels of inventory in the distribution channel, estimated shelf life, product recalls, product discontinuances, price changes of competitive products, introductions of generic products, introductions of competitive new products and lower demand following the loss of market exclusivity. Estimated returns for new products are determined after considering historical sales return experience of similar products, such as those within the same product line, similar therapeutic area and/or similar distribution model and estimated levels of inventory in the distribution channel and projected demand. The estimated amount for product returns is presented as a liability.
Use of information from external sources
Information from external sources is used to estimate GTN adjustments. Our estimate of inventory at the wholesalers is based on the projected prescription demand-based sales for our products and historical inventory experience, as well as our analysis of third-party information, including written and oral information obtained from certain wholesalers with respect to their inventory levels and sell-through to customers and third-party market research data, and our internal information. The inventory information received from wholesalers is a product of their recordkeeping process and excludes inventory held by intermediaries to whom they sell, such as retailers and hospitals.
We have also continued the practice of combining retail and mail prescription volume on a retail-equivalent basis. We use this methodology for internal demand forecasts. We also use information from external sources to identify prescription trends, patient demand and average selling prices. Our estimates are subject to inherent limitations of estimates that rely on third-party information, as certain third-party information was itself in the form of estimates, and reflect other limitations including lags between the date as of which third-party information is generated and the date on which we receive third-party information.
Acquisition and Intangible Assets Valuations
We make certain judgments to determine whether transactions should be accounted for as acquisitions of assets or as business combinations. If it is determined that substantially all of the fair value of gross assets acquired in a transaction is concentrated in a single asset (or a group of similar assets), the transaction is treated as an acquisition of assets. We evaluate the inputs, processes, and outputs associated with the acquired set of activities and assets. If the assets in a transaction include an input and a substantive process that together significantly contribute to the ability to create outputs, the transaction is treated as an acquisition of a business.
We account for business combinations using the acquisition method of accounting, which requires that assets acquired and liabilities assumed generally be recorded at their fair values as of the acquisition date. Excess of consideration over the fair value of net assets acquired is recorded as goodwill. Estimating fair value requires us to make significant judgments and assumptions.
In transactions accounted for as acquisitions of assets, no goodwill is recorded and contingent consideration, such as payments upon achievement of various developmental, regulatory and commercial milestones, generally is not recognized at the acquisition date. In an asset acquisition, upfront payments allocated to IPRD projects at the acquisition date are expensed unless there is an alternative future use. In addition, product development milestones are expensed upon achievement.
We have identifiable intangible assets that are measured at their respective fair values as of the acquisition date. Generally, we engage an independent third-party valuation firm to assist in determining the fair values of these assets as of the acquisition date. The fair value of these assets is estimated using discounted cash flow models. These models required the use of the following significant estimates and assumptions among others:
•Identification of product candidates with sufficient substance requiring separate recognition;
•Estimates of revenues and operating profits related to commercial products or product candidates;
•Eligible patients, pricing and market share used in estimating future revenues;
•Probability of success for unapproved product candidates and additional indications for commercial products;
•Resources required to complete the development and approval of product candidates;
•Timing of regulatory approvals and exclusivity;
•Appropriate discount rate by products;
•Market participant income tax rates; and
•Allocation of expected synergies to products.
We believe the fair value used to record intangible assets acquired are based upon reasonable estimates and assumptions considering the facts and circumstances as of the acquisition date.
Impairment and Amortization of Long-lived Assets, including Goodwill and Other Intangible Assets
Long-lived assets include intangible assets and property, plant and equipment and are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable or at least annually for Goodwill and IPRD. Intangible assets are highly vulnerable to impairment charges, particularly newly acquired assets for recently launched products or IPRD. These assets are initially measured at fair value and therefore any reduction in expectations used in the valuations could potentially lead to impairment. Some of the more common potential risks leading to impairment include changes in competitive landscape, earlier than expected loss of market exclusivity, pricing reductions, adverse regulatory changes or clinical study results, delay or failure to obtain regulatory approval for initial or follow on indications and unanticipated development costs, inability to achieve expected synergies resulting from cost savings and avoidance, higher operating costs, changes in tax laws and other macro-economic changes. The complexity in estimating the fair value of intangible assets in connection with an impairment test is similar to the initial valuation. If the carrying value of long-lived assets exceeds its fair value, then the asset is written-down to its fair value. Expectations of future cash flows are subject to change based upon the near and long-term production volumes and margins generated by the asset as well as any potential alternative future use. The estimated useful lives of long-lived assets are subjective and require significant judgment regarding patent lives, future plans and external market factors. Long-lived assets are also periodically reviewed for changes in facts or circumstances resulting in a reduction to the estimated useful life of the asset, requiring the acceleration of depreciation or amortization. Intangible asset impairment charges included in Cost of products sold, Research and development, and Other (income)/expense, net were $949 million in 2025, $2.9 billion in 2024 and $136 million in 2023. Refer to "Item 8. Financial Statements and Supplementary Data-Note 15. Goodwill and Other Intangible Assets" for further discussion and analysis of these impairment charges.
Income Taxes
Valuation allowances are recognized to reduce deferred tax assets when it is more likely than not that a tax benefit will not be realized. The assessment of whether or not a valuation allowance is required often requires significant judgment including long-range forecasts of future taxable income and evaluation of tax planning initiatives. Adjustments to the deferred tax valuation allowances are made to earnings in the period when such assessments are made. Our deferred tax assets were $8.9 billion at December 31, 2025 (net of valuation allowance of $960 million) and $8.4 billion at December 31, 2024 (net of valuation allowance of $929 million).
The U.S. federal net operating loss carryforwards were $1.3 billion at December 31, 2025. These carryforwards were acquired as a result of certain acquisitions and while they generally have unlimited lives, they are subject to limitations under Section 382 of the Internal Revenue Code. Foreign and state net operating loss carryforwards begin expiring in varying years starting in 2026 (certain amounts have unlimited lives).
Liabilities are established for possible assessments by tax authorities resulting from known tax exposures including, but not limited to, transfer pricing matters, tax credits and deductibility of certain expenses. Such liabilities represent a reasonable provision for taxes ultimately expected to be paid and may need to be adjusted over time as more information becomes known.
For discussions on income taxes, refer to "Item 8. Financial Statements and Supplementary Data-Note 1. Accounting Policies and Recently Issued Accounting Standards-Income Taxes" and "-Note 7. Income Taxes."
Contingencies
In the normal course of business, we are subject to contingencies, such as legal proceedings and claims arising out of our business, that cover a wide range of matters, including, among others, government investigations, shareholder lawsuits, product and environmental liability, contractual claims and tax matters. We recognize accruals for such contingencies when it is probable that a liability will be incurred and the amount of the loss can be reasonably estimated. These estimates are subject to uncertainties that are difficult to predict and, as such, actual results could vary from these estimates.
For discussions on contingencies, refer to "Item 8. Financial Statements and Supplementary Data-Note 1. Accounting Policies and Recently Issued Accounting Standards-Contingencies," "-Note 7. Income Taxes" and "-Note 20. Legal Proceedings and Contingencies."
Product and Pipeline Developments
Our R&D programs are managed on a portfolio basis from early discovery through late-stage development and include a balance of early-stage and late-stage programs to support future growth. Our late-stage development programs could potentially have an impact on our revenue and earnings within the next few years if regulatory approvals are obtained and products are successfully commercialized. The following are the late-stage new indication developments in our marketed products, as well as developments in our late-stage pipeline:
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Abecma & Breyanzi
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Multiple Indications
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June 2025
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Announced FDA approval of label updates to reduce certain patient monitoring requirements and remove the REMS programs that had been in place since each product was initially approved.
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Augtyro
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NSCLC and Solid Tumor
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February 2025
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Announced EC approval of Augtyroas a treatment for ROS1 TKI-naïve and -pre-treated adult patients with ROS1-positive advanced NSCLC 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 provided limited clinical benefit, or have been exhausted. The approval is based on results from the TRIDENT-1 and CARE trials.
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NTRK Solid Tumors
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November 2025
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Announced that Japan's Ministry of Health, Labour and Welfare approved the supplemental Japanese New Drug Application for Augtyrofor the treatment of NTRK fusion-positive, advanced or recurrent solid tumors. This approval is based on the results from the global Phase I/II TRIDENT-1 study and Japan Phase I/II CARE pediatric study.
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Breyanzi
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FL
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March 2025
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Announced EC approval of Breyanzifor the treatment of adult patients with relapsed or refractory FL after two or more lines of systemic therapy. This approval is based on results from the global, Phase II TRANSCEND FL study, the largest clinical trial to date to evaluate a CAR-T cell therapy in patients with relapsed or refractory indolent NHL, including FL.
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MCL
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November 2025
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Announced EC approval for Breyanzifor the treatment of adult patients with relapsed or refractory MCL after at least two lines of systemic therapy including a Bruton's tyrosine kinase (BTK) inhibitor. This approval is based on results from the MCL cohort of TRANSCEND NHL 001, in which Breyanzidemonstrated a high overall response rate of 82.7% and complete response rate of 71.6%, the study's primary and key secondary endpoints, respectively.
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MZL
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December 2025
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Announced FDA approval of Breyanzifor the treatment of adult patients with relapsed or refractory MZL who have received at least two prior lines of systemic therapy. This approval of Breyanziis based on results from the MZL cohort in the Phase II TRANSCEND FL study.
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MCL & MZL
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July 2025
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The supplemental Japanese New Drug Application for Breyanziwas submitted to Japan's Pharmaceuticals and Medical Devices Agency for the treatment of both relapsed or refractory MCL and relapsed or refractory MZL. This submission is based on Cohort 4 of the Phase II TRANSCEND FL study and the MCL cohort of the Phase I TRANSCEND NHL study.
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Indication
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Camzyos
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nHCM
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April 2025
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Announced that the Phase III ODYSSEY-HCM trial evaluating Camzyosfor the treatment of adult patients with symptomatic New York Heart Association class II-III nHCM did not meet its dual primary endpoints.
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oHCM
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January 2026
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Announced positive topline results from SCOUT-HCM, a Phase III trial evaluating Camzyosin the first study of a cardiac myosin inhibitor (CMI) in adolescents (ages 12 years to <18 years) with symptomatic oHCM. The trial met its primary endpoint, demonstrating a statistically significant reduction from baseline in Valsalva left ventricular outflow tract (LVOT) gradient at Week 28 versus placebo, indicating Camzyoswas effective in improving LVOT obstruction. Statistical significance was also met for multiple secondary endpoints, including those for clinically meaningful aspects of the disease. Safety results in the trial were consistent with the established safety profile of Camzyosin adults, and no new safety signals were reported in this new, younger population. The study continues with active treatment and long-term extension periods.
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August 2025
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Presented results from COLLIGO-HCM, a global retrospective real-world data study, at the European Society of Cardiology Congress 2025. The analysis showed that Camzyoswas associated with reductions in left ventricular outflow tract (LVOT) obstruction and improvements in symptom burden in a racially diverse population of patients with symptomatic oHCM treated in an international, real-world setting. The effectiveness and safety demonstrated in COLLIGO-HCM are consistent with results from randomized, controlled clinical trials and further support the growing body of evidence for Camzyos, the first and only approved cardiac myosin inhibitor, as a standard of care for New York Heart Association (NYHA) class II-III symptomatic oHCM.
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April 2025
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Announced that the FDA updated the U.S. Prescribing Information for Camzyos, simplifying treatment for patients and physicians by reducing the required echo monitoring for eligible patients in the maintenance phase and expanding patient eligibility by reducing contraindications.
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March 2025
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Announced that Japan's Ministry of Health, Labour and Welfare granted manufacturing and marketing approval for Camzyosfor the treatment of adults with oHCM. This approval is based on results from the global Phase III EXPLORER-HCM study and the Japan Phase III HORIZON-HCM study.
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February 2025
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In EU, following an opinion from the CHMP of the EMA, Camzyosreceived a label update to reduce the frequency of required echocardiography monitoring once a patient treated for oHCM is on a stable dose.
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Cobenfy
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AD Psychosis
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December 2025
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Announced that additional patients will be enrolled in the Phase III ADEPT-2 study evaluating Cobenfyin psychosis associated with Alzheimer's Disease. As part of our commitment to upholding the highest standards in clinical research and following a thorough blinded review of the ADEPT-2 study data, we identified irregularities due to clinical trial execution at a small number of study sites. With these findings, prior to database lock, BMS made the decision to exclude patient data from those sites from the primary analysis. Following consultation and agreement with the FDA, an interim data analysis for efficacy and safety was conducted by an independent party and reviewed by the Data Monitoring Committee. Following this analysis, the DMC recommended the study continue by enrolling additional patients to the original target study population. Based on this recommendation, BMS will continue patient enrollment and advance the program as advised by the DMC. BMS remains blinded to study data.
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Schizophrenia
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April 2025
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Announced that the Phase III ARISE trial evaluating Cobenfyas an adjunctive treatment to atypical antipsychotics in adults with schizophrenia did not meet the threshold for statistical significance for the primary endpoint.
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iberdomide
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RRMM
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September 2025
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Announced that the Phase III EXCALIBER-RRMM study evaluating iberdomide combined with standard therapies in patients with RRMM demonstrated a statistically significant improvement in minimal residual disease (MRD) negativity rates, compared with the control arm, in a planned interim analysis of the MRD endpoint. The safety profile of iberdomide in combination with daratumumab and dexamethasone in this study is generally consistent with previous studies.
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Inrebic
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Myelofibrosis
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June 2025
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Announced that Japan's Ministry of Health Labour and Welfare granted approval of Inrebicfor the treatment of myelofibrosis. This approval is based on results from the global Phase III Jakarta study, the global Phase III Jakarta-2 trial, and the Japan local Phase I/II trial (FEDR-MF-003).
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izalontamab brengitecan
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NSCLC
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August 2025
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Announced, with SystImmune, that the FDA granted Breakthrough Therapy Designation to izalontamab brengitecan (iza-bren) for the treatment of patients with locally advanced or metastatic NSCLC with mutated epidermal growth factor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy. The FDA's decision was based on the efficacy and safety data from three ongoing clinical trials: BL-B01D1-101, BL-B01D1-203 and BL-B01D1-LUNG-101.
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milvexian
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ACS
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November 2025
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Announced, in collaboration with Johnson & Johnson, the decision to stop the Phase III Librexia ACS trial evaluating the efficacy and safety of milvexian when added to the standard of care (conventional antiplatelet therapy) for patients after a recent ACS event. The decision to discontinue the trial follows a preplanned interim analysis by the Independent Data Monitoring Committee, which determined the trial is unlikely to meet the primary efficacy endpoint. No new safety concerns related to the investigational therapy were identified. The safety profile was consistent with previously reported studies of milvexian. The IDMC recommended that the other two Phase III trials, Librexia AF for patients with atrial fibrillation AF and Librexia STROKE for secondary stroke prevention, continue as planned, with topline data expected in 2026.
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obexelimab
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IgG4-RD
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January 2026
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Our partner, Zenas BioPharma, Inc., announced positive results from the Phase III INDIGO trial of obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD). Obexelimab met the primary endpoint, demonstrating a highly statistically significant and clinically meaningful 56% reduction in the risk of IgG4-RD flare compared to placebo during the 52-week randomized placebo-controlled period. Obexelimab also met and demonstrated highly statistically significant activity compared to placebo on all four key secondary endpoints, which were reduction in investigator assessed IgG4-RD flare, the number of flares requiring rescue therapy, the proportion of patients achieving complete remission and the cumulative use of IgG4-RD rescue therapy. Rates of infections, including Grade 3, were lower in the obexelimab arm compared to placebo, and the incidence of injection site reactions was similar across both study arms.
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Onureg
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AML
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November 2025
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The Japanese New Drug Application was submitted to Japan's Pharmaceuticals and Medical Devices Agency for Onuregfor maintenance therapy of AML after remission induction therapy. This filing was based on results from the global Phase III QUAZAR (CC-486-AML-001) study and the Japan Phase II CA055005 study.
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Opdivo
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cHL
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December 2025
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Announced that the FDA accepted and granted priority review to the sBLA for Opdivoin combination with doxorubicin, vinblastine and dacarbazine (AVD) for adult and pediatric (12 years and older) patients with previously untreated Stage III or IV classical Hodgkin Lymphoma. The FDA filing acceptance is based on the Phase III CA2098UT study. The FDA assigned a PDUFA goal date of April 8, 2026.
In addition, the EMA validated the Type II variation application for Opdivo plus doxorubicin, vinblastine and dacarbazine for adults and adolescents (12 years of age and older) with previously untreated Stage III or IV cHL. Validation confirms the submission is complete and begins the EMA's centralized review procedure.
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NSCLC
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May 2025
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Announced EC approval of Opdivo,in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Opdivo as monotherapy as adjuvant treatment after surgical resection for the treatment of resectable NSCLC at high risk of recurrence in adult patients whose tumors have PD-L1 expression ≥1%. This approval is based on the results from the CheckMate -77T study, in which the trial met its primary endpoint of event-free survival and showed clinically meaningful improvements in the secondary efficacy endpoints of pathologic complete response and major pathologic response.
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February 2025
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Announced that the final analysis of overall survival from the Phase III CheckMate -816 study evaluating Opdivoin combination with platinum-doublet chemotherapy as a neoadjuvant treatment for adult patients with resectable NSCLC. The results showed a statistically significant and clinically meaningful improvement in the key secondary endpoint of overall survival compared to neoadjuvant chemotherapy alone.
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Opdivo Qvantig
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Multiple Indications
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May 2025
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Announced EC approval of Opdivo Qvantiginjection for subcutaneous use, in most previously approved adult, solid tumor Opdivoindications as monotherapy, monotherapy maintenance following completion of Opdivo + Yervoycombination therapy, or in combination with chemotherapy or cabozantinib. This approval is based primarily on results from the Phase III CheckMate -67T trial which demonstrated noninferiority in the co-primary endpoints of Cavgd28 (time-averaged Opdivoserum concentration over 28 days) and Cminss (trough serum concentration at steady state) and consistent efficacy in the secondary endpoint of ORR for the subcutaneous formulation ofOpdivovs. its intravenous formulation.
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Opdivo + Yervoy
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CRC
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August 2025
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Announced that Japan's Ministry of Health Labour and Welfare approved Opdivo+ Yervoyfor the treatment of unresectable advanced or recurrent microsatellite instability-high colorectal cancer. This approval is based on the results from the Phase III CheckMate-8HW study.
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April 2025
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Announced FDA approval of Opdivo + Yervoyas a first-line treatment of adult and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high or mismatch repair deficient CRC. This approval is based on the Phase III CheckMate -8HW trial. This approval, granted more than two months ahead of the June 23, 2025 PDUFA goal date, follows the FDA's prior decision to grant the application Breakthrough Therapy Designation and Priority Review status.
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HCC
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June 2025
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Announced that Japan's Ministry of Health Labour and Welfare granted approval of Opdivo+ Yervoyfor the treatment of unresectable HCC. This approval is based on the results from the global Phase III CheckMate -9DW trial.
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April 2025
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Announced FDA approval of Opdivo+ Yervoyas a first-line treatment for adult patients with unresectable or metastatic HCC. This approval is based on the results from the global Phase III CheckMate -9DW trial.
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March 2025
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Announced EC approval of Opdivo+ Yervoyfor the first-line treatment of adult patients with unresectable or advanced HCC. The approval is based on results from the CheckMate -9DW study, in which the dual immunotherapy treatment led to a statistically significant and clinically meaningful improvement in overall survival, the clinical trial's primary endpoint.
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Opdualag
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Melanoma
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February 2025
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Announced that the Phase III RELATIVITY-098 trial evaluating Opdualagfor the adjuvant treatment of patients with completely resected stage III-IV melanoma did not meet its primary endpoint of recurrence-free survival. The safety profile of Opdualagobserved in this analysis was consistent with the known profiles of nivolumab and relatlimab.
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Reblozyl
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MF-Associated Anemia
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July 2025
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Announced that the Phase III INDEPENDENCE trial evaluating Reblozylwith concomitant janus kinase inhibitor therapy in adult patients with myelofibrosis-associated anemia receiving red blood cell (RBC) transfusion did not meet its primary endpoint of RBC transfusion independence.
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Product
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Indication
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Date
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Developments
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Sotyktu
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Plaque Psoriasis
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February 2025
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Announced new five-year results from the POETYK PSO long-term extension trial of Sotyktutreatment in adult patients with moderate-to-severe plaque psoriasis, in which the safety profile of Sotykturemained consistent through five years with more than 5,000 patient-years of exposure in the trial, with no new safety signals identified. In patients who were treated continuously with Sotyktu, clinical response rates were maintained from Year 1 to Year 5, including Psoriasis Area and Severity Index (PASI) 75, PASI 90 and static Physician's Global Assessment (sPGA) 0/1 (clear/almost clear).
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PsA
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October 2025
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Announced that the Phase III POETYK PsA-1 trial further confirmed the efficacy and safety of Sotyktuin adults with active PsA who were not previously treated with a biologic disease-modifying antirheumatic drug. The trial demonstrated that Sotyktuimproved and maintained meaningful clinical responses, inhibition of radiographic progression and patient-reported outcomes through Week 52 in adults with active PsA.
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July 2025
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The FDA accepted for review the supplemental New Drug Application (sNDA) for Sotyktufor the treatment of adults with active psoriatic arthritis. The FDA assigned PDUFA goal date of March 6, 2026.
In addition, China's Center for Drug Evaluation of National Medical Products Administration and Japan's Ministry of Health, Labour and Welfare accepted sNDAs for Sotyktuin the same indication. The EMA has also validated the Type II variation application to expand the indication for Sotyktuto include this disease. The regulatory applications are based on the pivotal POETYK PsA-1 and POETYK PsA-2 trials.
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June 2025
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Announced positive data from the pivotal Phase III POETYK PsA-1 trial evaluating the efficacy and safety of Sotyktuin adults with active PsA. The trial met its primary endpoint, with a significantly greater proportion of Sotyktu-treated patients achieving ACR20 response (at least a 20 percent improvement in signs and symptoms of disease) after 16 weeks of treatment compared with placebo (54.2% versus 34.1%, respectively). Additionally, treatment with Sotyktumet important secondary endpoints across PsA disease activity at Week 16, demonstrating improvement across clinical measures, extra-articular manifestations and patient-reported outcomes. The overall safety profile of Sotyktuthrough 16 weeks of treatment was consistent with what has been reported throughout the clinical trial programs for Sotyktu, including the Phase III POETYK PsA-2 and the Phase III moderate-to-severe plaque psoriasis clinical trials.
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June 2025
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The supplemental Japanese New Drug Application for Sotyktuwas submitted to Japan's Pharmaceuticals and Medical Devices Agency for the treatment of adults with active PsA. This filing includes 16-week efficacy/safety data from the Phase III PsA-1 trial and 52-week efficacy/safety data from the Phase III PsA-2 trial.
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March 2025
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Announced positive data from the pivotal Phase III POETYK PsA-2 trial evaluating the efficacy and safety of Sotyktuin adults with active PsA. The trial met its primary endpoint, with a significantly greater proportion of Sotyktu-treated patients achieving ACR20 response (at least a 20 percent improvement in signs and symptoms of disease) after 16 weeks of treatment compared with placebo (54.2% versus 39.4%, respectively). Additionally, treatment with Sotyktumet important secondary endpoints across PsA disease activity at Week 16, demonstrating improvement across clinical signs and symptoms, extra-articular manifestations and patient-reported outcomes. The overall safety profile of Sotyktuthrough 16 weeks of treatment was consistent with that established in a Phase II PsA clinical trial and Phase III moderate-to-severe plaque psoriasis clinical trials.
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Special Note Regarding Forward-Looking Statements
This 2025 Form 10-K (including documents incorporated by reference) and other written and oral statements we make from time to time contain certain "forward-looking" statements within the meaning of Section 27A of the Securities Act, and Section 21E of the Exchange Act. You can identify these forward-looking statements by the fact 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. One can also identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements are based on our current expectations and projections about our 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, and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These statements are likely to relate to, among other things, our goals, plans and objectives regarding our financial position, results of operations, cash flows, market position, product development, product approvals, sales efforts, expenses, performance or results of current and anticipated products, our business development strategy and in relation to our ability to realize the projected benefits of our acquisitions, alliances and other business development activities, the impact of any pandemic or epidemic on our operations and the development and commercialization of our products, laws, agreements and regulations to lower drug prices, government actions relating to the imposition of new tariffs, market actions taken by private and government payers to manage drug utilization and contain costs, the expiration of patents or data protection on certain products, including assumptions about our ability to retain marketing exclusivity of certain products, and the outcome of contingencies such as legal proceedings and financial results. No forward-looking statement can be guaranteed. We have included important factors in the cautionary statements included in this 2025 Form 10-K, particularly under "Item 1A. Risk Factors," that we believe could cause actual results to differ materially from any forward-looking statement.
Although we believe that we have been prudent in our plans and assumptions, no assurance can be given that any goal or plan set forth in forward-looking statements can be achieved and readers are cautioned not to place undue reliance on such statements, which speak only as of the date made. Additional risks that we may currently deem immaterial or that are not presently known to us could also cause the forward-looking events discussed in this 2025 Form 10-K not to occur. Except as otherwise required by applicable law, we undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise after the date of this 2025 Form 10-K.