BRISTOL MYERS SQUIBB CO

Bristol-Myers Squibb Company operates in a single segment engaged in the discovery, development, licensing, manufacturing, marketing, distribution and sale of innovative medicines that help patients prevail over serious diseases. The company's focus as a biopharmaceutical company is on discovering, developing and delivering transformational medicines for patients facing serious diseases in areas where it believes it has an opportunity to make a meaningful difference: oncology, hematology, immunology, cardiovascular, neuroscience and other areas where it can also create long-term value. The company competes with other global research-based drug companies, many smaller research companies with more limited therapeutic focus and generic drug manufacturers. Its products are sold worldwide, principally to wholesalers, distributors, specialty pharmacies, and to a lesser extent, retailers, hospitals, clinics, government agencies and directly to patients.

The company competes with other global research-based drug companies, many smaller research companies with more limited therapeutic focus and generic drug manufacturers. Important competitive factors include product efficacy, safety and ease of use, price and demonstrated cost-effectiveness, marketing effectiveness, product labeling, customer service and R&D of new products and processes. The company's immuno-oncology products, particularly Opdivo, operate in a highly competitive marketplace. The company believes its long-term competitive position depends upon its success in discovering and developing innovative, cost-effective products that serve unmet medical needs, along with its ability to manufacture products efficiently and to market them effectively in a highly competitive environment.

The company generates revenue primarily through net product sales, which represented more than 95% of total revenues for all periods presented. Products are sold principally to wholesalers, distributors, specialty pharmacies, and to a lesser extent, directly to retailers, hospitals, clinics, government agencies and patients. Revenue is recognized following a five-step model and is reduced for gross-to-net sales adjustments involving significant estimates and judgment. The company also earns alliance and other revenues from collaborations and out-licensing arrangements.

The Growth Portfolio includes Opdivo, which generated $10.049 billion ¹ in 2025, Opdivo Qvantig at $238 million ², Orencia at $3.705 billion ³, Yervoy at $2.900 billion ⁴, Reblozyl at $2.327 billion ⁵, Breyanzi at $1.358 billion ⁶, Opdualag at $1.185 billion ⁷, Camzyos at $1.068 billion ⁸, Zeposia at $577 million ⁹, Abecma at $427 million ¹⁰, Sotyktu at $291 million ¹¹, Krazati at $205 million ¹², Cobenfy at $155 million ¹³, and Other Growth Products at $1.924 billion ¹⁴. Total Growth Portfolio revenues were $26.409 billion ¹⁵ in 2025. The Legacy Portfolio includes Eliquis at $14.443 billion ¹⁶, Revlimid at $2.951 billion ¹⁷, Pomalyst/Imnovid at $2.733 billion ¹⁸, Sprycel at $493 million ¹⁹, Abraxane at $368 million ²⁰, and Other Legacy Products at $798 million ²¹. Total Legacy Portfolio revenues were $21.785 billion ²² in 2025.

In 2025, the company acquired Orbital Therapeutics, which provided full rights to OTX-201, a preclinical in vivo CAR T-cell therapy currently in IND-enabling studies for autoimmune disease. The company 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. The company acquired a global exclusive license from Philochem for OncoACP3, a radiopharmaceutical therapeutic and diagnostic agent targeting prostate cancer. The company expanded its development and manufacturing capabilities by opening a new radiopharmaceutical facility in Indianapolis, Indiana. In November 2025, BMS Ireland Capital Funding Designated Activity Company completed a registered public offering of €5.0 billion ²³ in aggregate principal amount of euro-denominated senior unsecured notes, with proceeds, net of loan issuance costs, of $5.7 billion ²⁴. In November and December 2025, the company repurchased certain debt obligations of $8.7 billion ²⁵ in aggregate principal amount for $9.1 billion ²⁶ of cash in a series of tender offers and "make whole" redemptions, recognizing a $356 million ²⁷ loss on debt redemption. The company also announced the U.S. Government Agreement in December 2025, agreeing to provide Eliquis for free to the Medicaid program effective January 1, 2026, donate more than seven tons of Eliquis API to fill the U.S. Strategic Active Ingredient Reserve, enable direct-to-patient access to Sotyktu, Zeposia, Reyataz, Baraclude and Orencia for cash-paying patients at discounts approximately 80% off current list prices, adopt a more balanced pricing approach for new launches across developed nations, and continue to expand domestic production.

Total revenues were $48.194 billion ²⁸ in 2025, compared to $48.300 billion ²⁹ in 2024. Net earnings attributable to BMS were $7.054 billion ³⁰ in 2025, compared to a net loss of $8.948 billion ³¹ in 2024. Diluted earnings per share attributable to BMS on a GAAP basis were $3.46 ³² in 2025, compared to a loss of $4.41 ³³ in 2024. Non-GAAP diluted earnings per share were $6.15 ³⁴ in 2025, compared to $1.15 ³⁵ in 2024. The $7.87 change in GAAP EPS 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 the ongoing strategic productivity initiative.

The company did not issue specific formal revenue, margin, or EPS guidance for the upcoming period in the 10-K filing. However, management stated that it continues to expect to realize approximately $2.0 billion ³⁶ in cost savings by the end of 2027 in connection with the 2025 expansion of its ongoing strategic productivity initiative.

In oncology, the company is focused on extending and strengthening its leadership in immuno-oncology, as well as diversifying beyond immuno-oncology. During 2025, the company 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. The company also believes it has significant opportunity in radiopharmaceuticals as a new oncology modality with opportunities to advance RYZ101, RYZ401 and RYZ801. In hematology, the company sees significant potential with its 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, the company is building on its expertise and leadership, developing next generation CAR-T treatments with first-in-class potential, including in vivo CAR-T cell therapies. The company is 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. The company is exploring zola-cel's potential in multiple disease areas, including SLE, SSc and other indications. In immunology, the company is developing admilparant, its 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. The company has 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.

The company continues to expect to realize approximately $2.0 billion ³⁷ in cost savings by the end of 2027 in connection with the 2025 expansion of its ongoing strategic productivity initiative. The exit costs resulting from these actions are included in the updated 2023 Restructuring Plan. Selling, general and administrative expenses decreased by $1.1 billion or 14% in 2025, 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 expense decreased by $1.2 billion or 11% in 2025, 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.

The company has significant manufacturing operations in the U.S., Puerto Rico, the Netherlands, Ireland and Switzerland. The company continues to make capital investments in its Devens, Massachusetts and other global manufacturing facilities. During 2025, the company completed the construction of a new state-of-the-art cell therapy manufacturing facility in Leiden, Netherlands. The company also opened a new radiopharmaceutical facility in Indianapolis, Indiana during 2025. The company expects to continue modification of its existing manufacturing network to meet complex processing standards required for its growing portfolio, particularly biologics and cell therapy. The company continues to partner with third party manufacturers to expand supply of vector and is investing in new facilities for drug product manufacturing. Longer-term, the company is accelerating its plans to transition to new vector technologies with a dual sourcing strategy.

Research and development expenses were $10.0 billion ³⁸ in 2025, $11.2 billion ³⁹ in 2024 and $9.3 billion ⁴⁰ in 2023. Acquired IPRD expenses were $3.7 billion ⁴¹ in 2025, $13.4 billion ⁴² in 2024 and $913 million ⁴³ in 2023. Annual capital expenditures were approximately $1.3 billion ⁴⁴ in 2025, $1.2 billion ⁴⁵ in 2024 and $1.1 billion ⁴⁶ in 2023 and are expected to be approximately $1.3 billion ⁴⁷ in 2026. The remaining share repurchase capacity under the BMS share repurchase program was $5.0 billion ⁴⁸ as of December 31, 2025. There were no share repurchases in 2025. Dividend payments were $5.0 billion ⁴⁹ in 2025 and $4.9 billion ⁵⁰ in 2024. Dividend paid per common share was $0.62 ⁵¹ during each quarter of 2025.

The company faces increased pricing pressure and other restrictions in the U.S. and abroad that continue to negatively affect its revenues and profit margins. 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. The Inflation Reduction Act has and will continue to have the effect of reducing prices and reimbursements for certain of the company's products. In August 2024, 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 Orencia as a medicine subject to "negotiation" for government-set prices beginning in 2028. The company also faces the risk of losing market exclusivity of a product earlier than expected, as generic and biosimilar product manufacturers increasingly seek to challenge patents before they expire.

The company expects continued generic erosion within its Legacy Portfolio in 2026 primarily due to Revlimid and Pomalyst in the U.S. For Eliquis, in the U.S., multiple generic companies challenged patents listed in the FDA Orange Book. Under the terms of previously executed settlement agreements, the generic companies with whom BMS settled are permitted to launch in 2028, subject to additional challenges. In the EU, the apixaban composition of matter patents and related SPCs expire in November 2026. Generics have challenged the composition of matter patents and related SPCs in various jurisdictions and trials have taken place, or are scheduled to take place, in certain European countries. While these legal proceedings are pending, generic manufacturers have begun marketing generic versions of Eliquis in certain EU countries. For Revlimid, in the U.S., certain generic companies have begun marketing generic lenalidomide products pursuant to volume-limited licenses granted as part of litigation settlements. As of January 31, 2026, the licenses are no longer volume-limited. For Pomalyst, generic entry is expected in the first quarter of 2026 in the U.S.

The company faces intense competition from generic pharmaceutical manufacturers, and when a branded product loses its market exclusivity, it normally faces intense price competition from generic forms of the product, leading to a rapid loss of revenue. For Revlimid, as of January 31, 2026, the volume-limited licenses for generic lenalidomide are no longer volume-limited, and for Pomalyst, generic entry is expected in the first quarter of 2026 in the U.S. The company is also subject to increased pricing pressure from government actions, including the Inflation Reduction Act, which has resulted in the HHS announcing a "maximum fair price" for Eliquis effective January 1, 2026, and for Pomalyst effective January 1, 2027, and selecting Orencia for negotiation beginning in 2028. The company's future success is highly dependent on its pipeline of new products, and there is a high rate of failure inherent in the research and development process for new drugs, with approximately 93% of small molecules that enter Phase I development failing to achieve regulatory approval according to the KMR Group. The company also depends on several key products for most of its revenues, cash flows and earnings, and expects that Eliquis, Opdivo, Opdivo Qvantig, Orencia, Reblozyl and Yervoy will represent a significant percentage of its revenue, earnings and cash flows during the next few years. A reduction in revenue from any of these products due to loss of market exclusivity or other factors could adversely impact earnings and cash flows.

Management's message emphasizes the company's principal strategy 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. The key strategic priorities are to focus on transformational medicines where the company has a competitive advantage, drive operational excellence throughout the organization and strategically allocate capital for long-term growth and shareholder returns. Management stated that the company continues to expect to realize approximately $2.0 billion ⁵² in cost savings by the end of 2027 in connection with the 2025 expansion of its ongoing strategic productivity initiative. The tone is forward-looking, highlighting multiple regulatory approvals achieved in 2025, the advancement of the pipeline through internal research and development and business development activities, and a commitment to strategic allocation of resources and investing in areas that maximize value and drive sustainable growth.