BMY 10-K & 10-Q changes, risk factors and insider trading
Bristol Myers Squibb Co. (also CELG-RI) · NYSE · Pharmaceutical Preparations · CIK 14272 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “unforeseen disruptions. Manufacturers that fail to comply with the IRA may be subject to various penalties, including civil monetary penalties, which could be significant. The IRA has and will continue to meaningfully impact our business strategies and those of others in the pharmaceutical industry. 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.”
New heading “In July 2025, the OBBBA was enacted which, among other things, aims to achieve efficiencies in U.S. federal government healthcare spending over the next decade, primarily within Medicaid. We are continuing to assess the full scope of this legislation and its potential commercial implications, and it is possible that these changes may impact our cash flows and results of operations.”
New heading “introduction of competitive products that treat diseases and conditions like those treated by our products and product candidates. Business combinations among our competitors and major third-party payers may also increase competition for our products. If we are unable to compete successfully against our competitors’ products in the marketplace, this could have a material negative impact on our revenues and earnings.”
New heading “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. We continue to evaluate the impacts of tariffs on our business and results of operations, and it is possible that such tariffs, or future tariffs, may result in a material impact on our business and results of operations.”
New heading “brand and reputation, reduced demand for our products, inability to attract and retain employee talent or other negative impacts on our business and operations.”
New heading “imposed on us that could have a material adverse effect on our competitive position, cash flows, results of operations, financial condition or reputation.”
New heading “competitive products enter the market or clinical trial results for our competitors’ products affect the value proposition for our product. Any such delays or difficulties in clinical development could also potentially lead to a material impairment of our intangible assets, including the $19.1 billion of other intangible assets as of December 31, 2025.”
New heading “face additional litigation costs in pursuing any such claim, particularly if they do not reside in or near Delaware. While we believe the risk of a court declining to enforce the forum selection provision contained in our amended bylaws is low, if a court were to find the provision inapplicable to, or unenforceable in respect of, one or more of the specified types of actions or proceedings, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business, operating results and financial condition.”
Removed heading “Commercialization launch delays are especially common when a product is expected to have a REMS program, as required by the FDA to address significant risk/benefit issues. Certain of our future key products may be required to be distributed in the U.S. through”
Removed heading “In addition, in December 2023, the Biden administration released a proposed framework that for the first time proposed that a drug’s price can be a factor in determining that the drug is not accessible to the public and, therefore, that the government could exercise “march-in rights” and license it to a third party to manufacture. We cannot predict whether the Trump administration will finalize the draft framework or if the government will propose other drug pricing policy changes. If pursued and finalized, these policies could reduce prices and reimbursement for certain of our products and could significantly impact our business and consolidated results of operations.”
Removed heading “interact with these entities. We cannot predict how other future federal or state legislative or administrative changes relating to healthcare reform will affect our business. For additional information, refer to “Item 1. Business—Government Regulation,” “Item 1. Business—Pricing, Price Constraints and Market Access” and “—Legal matters could negatively affect our business.” Similarly, the legislative and regulatory environment regarding cybersecurity, data protection, storage and privacy is continuously evolving and the subject of significant attention by regulators and private parties globally. Regulators are imposing new cybersecurity and data”
Removed heading “protection, storage and privacy requirements, including new and greater monetary fines or penalties for privacy violations, and jurisdictions where we operate have passed, or continue to propose, data privacy legislation and or regulations. Failure to comply with these laws could result in significant penalties, including potential exclusion from federal healthcare programs, and reputational harm and could have a material adverse effect on our business and results of operations.”
Removed heading “Pharmaceutical products receive regulatory approval based on data obtained in controlled clinical trials of limited duration. Additional clinical trials, head-to-head studies, real-world data analyses, adverse events reports following the use of our products”
Removed heading “stage pipeline, manage change from our operating model evolution or manage our costs effectively, our operating results and financial condition could be negatively impacted.”
Removed heading “Global economic and political risks pose significant challenges to a company’s growth and profitability and are difficult to mitigate. We generated approximately 29% of our revenues outside of the U.S. in 2024. As such, a global economic downturn could create or amplify a variety of risks to our business and could negatively affect our growth. In addition, uncertainty in the credit and capital”
Removed heading “Our amended bylaws provide that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware will be, to the fullest extent permitted by law, the sole and exclusive forum for any (i) derivative action or proceeding brought on our behalf, (ii) action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers or other employees to us or our stockholders, creditors or other constituents, (iii) action asserting a claim arising pursuant to any”
Largest changes
“protection, storage and privacy requirements, including new and greater monetary fines or penalties for privacy violations, and jurisdictions where we operate have passed, or continue to propose, data privacy legislation and or regulations. Failure to comply with these laws could result in significant penalties, including potential exclusion from federal healthcare programs, and reputational harm and could have a material adverse effect on our business and results of operations.”see in full comparison
Our product supply and related patient access has been, and could in the future be, negatively impacted by difficulties, delays and disruptions in the manufacturing, distribution and sale of our products. Some of the difficulties, delays and disruptions include: (i) product seizures or recalls or forced closings of manufacturing plants; (ii) our failure, or the failure of any of our vendors or suppliers, to comply with cGMP and other applicable regulations or quality assurance guidelines that could lead to manufacturing shutdowns, product shortages or delays in product manufacturing; (iii) manufacturing, quality assurance/quality control, supply problems or governmental approval delays; (iv)see in full comparisonthe failure of a supplier, including sole source or single source suppliers, to provide us with the necessary raw materials, supplies or finished goods within a reasonable timeframe and with required quality; (v) the failure of a third-party manufacturer to supply us with bulk active or finished product on time; (vi) construction or regulatory approval delays for new facilities or the expansion of existing facilities, including those intended to support future demand for our biologics products; (vii) the failure to meet new and emerging regulations requiring products to be tracked throughout the distribution channels using unique identifiers to verify their authenticity in the supply chain; (viii) other manufacturing or distribution issues, including limits to manufacturing capacity and changes in the types of products produced, such as biologics, physical limitations, labor disputes or shortages, or other business interruptions; (ix)geopolitical factors in a specific country or region, including any new, or changes in or interpretations of existing, trade regulations, including for example, any new tariffs imposed in the jurisdictions in which we operate, or compliance requirements of other legislation; (v) the failure of a supplier, including sole source or single source suppliers, to provide us with the necessary raw materials, supplies or finished goods within a reasonable timeframe and with required quality; (vi) the failure of a third-party manufacturer to supply us with bulk active or finished product on time; (vii) construction or regulatory approval delays for new facilities or the expansion of existing facilities, including those intended to support future demand for our biologics products; (viii) the failure to meet new and emerging regulations requiring products to be tracked throughout the distribution channels using unique identifiers to verify their authenticity in the supply chain; (ix) other manufacturing or distribution issues, including limits to manufacturing capacity and changes in the types of products produced, such as biologics, physical limitations, labor disputes or shortages, or other business interruptions; and (x) disruptions in supply chain continuity, including from market forces, natural disasters, global disease outbreaks orpandemics (including COVID-19),pandemics, acts of war or terrorism or other unforeseeable or unavoidable events that materially impact one or more of our facilities or a critical supplier.
“We participate in the 340B program, under which we must offer covered outpatient drugs to statutorily defined covered entities at no more than the 340B program “ceiling price”. The expanded utilization of the 340B program in recent years has negatively affected our revenues and profit margins. Additionally, manufacturers who are found to have knowingly and intentionally overcharged 340B program covered entities could be subject to significant monetary penalties. …”see in full comparison
“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. We continue to evaluate the impacts of tariffs on our business and results of operations, and it is possible that such tariffs, or future tariffs, may result in a material impact on our business and results of operations.”see in full comparison
“face additional litigation costs in pursuing any such claim, particularly if they do not reside in or near Delaware. While we believe the risk of a court declining to enforce the forum selection provision contained in our amended bylaws is low, if a court were to find the provision inapplicable to, or unenforceable in respect of, one or more of the specified types of actions or proceedings, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business, operating results and financial condition.”see in full comparison
“Our amended bylaws provide that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware will be, to the fullest extent permitted by law, the sole and exclusive forum for any (i) derivative action or proceeding brought on our behalf, (ii) action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers or other employees to us or our stockholders, creditors or other constituents, (iii) action asserting a claim arising pursuant to any”see in full comparison
Full comparison: every changed paragraph (57)
Our products continue to be subject to increasing pressures across the portfolio from pharmaceutical market access and pricing controls, required rebates and other discounts, in the U.S., the EU and other regions around the world that result in lower prices, lower reimbursement rates and smaller populations for whom payers will reimburse. We expect that these market access constraints, pricing controls and discounting and other restrictions will become more acute as public and private payers continue to take aggressive steps to control their expenditures. Our future revenues and profit margins could be negatively affected, including as a result of (i) changes in lawslaws, agreements and regulations relating to the pricing and reimbursement of pharmaceutical products (including potential penalties for increasing prices over the rate of inflation and government negotiations/price controls that may change the determination of the "best price" and establish a maximum allowed price/reimbursement rate), as well as other changes relating to federal healthcare programs, such as modifying the federal Anti-Kickback statute discount safe harborharbor, OBBBA and the IRA, which includes a number of provisions intended to lower the costs of some drugs covered under Medicare Part D and Medicare Part B and to limit Medicare beneficiaries’ out-of-pocket spending under the Medicare Part D benefit, (ii) expanded utilization and pharmaceutical company restrictions under the 340B Drug Pricing Program ("340B program"), (iii) cost-cutting measures by federal healthcare programs, such as Medicare and Medicaid, MCOs and other institutional and governmental purchasers, (iiiiv) the grant of additional authority to governmental agencies to manage drug utilization and negotiate drug prices (including the implementation of the 2020 regulation issued by the U.S. federal government authorizing states and private parties to develop and implement programs to import certain prescription drugs from Canada and sell them in the U.S., and the American Rescue Plan Act of 2021, which eliminated the Medicaid Prescription Drug Rebate cap as of January 1, 2024), (iv) expanded utilization and pharmaceutical company restrictions under the 340B Drug Pricing Program ("340B program"), (v) competition related to placements on applicable commercial and Medicare Part D formularies; (vi) changes to U.S. federal pharmaceutical coverage and reimbursement policies and practices, (vii) the increased purchasing power of entities that negotiate on behalf of Medicare, Medicaid and private sector beneficiaries, (viii) the increased scrutiny of drug manufacturers (including any additional review of BMSthe or CelgeneCompany by the HouseUnited OversightStates and Reform CommitteeCongress), (ix) reimbursement delays, (x) government price erosion mechanisms across Europe, Japan and in other countries resulting in deflation for pharmaceutical product pricing, (xi) collection delays or failures to pay in government-funded public hospitals outside the U.S., (xii) developments in technology and/or industry practices that could impact the reimbursement policies and practices of third-party payers, and (xiii) inhibited market access due to real or perceived differences in value propositions for our products compared to competing products.
In particular, the IRA has and will continue to have the effect of reducing prices and reimbursements for certain of our products, which could significantly impact our business. Under the IRA, the HHS can effectively set prices for units of certain single-source drugs and biologics reimbursed under Medicare Part B, Medicare Advantage and Part D. Generally, these government prices apply nine years (for small molecule drugs) or 13 years (for biological productsbiologics) following FDA approval and will be capped at a statutory ceiling price that is likely to represent a significant discount from average prices to wholesalers and direct purchasers. 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 JanuaryNovember 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 PomalystOrencia as a medicine subject to "negotiation" for government-set prices beginning in 2027.2028. It is possible that more of our products could be selected in future years,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. Failure to comply with requirements under the price setting process is subject to an excise tax and/or a civil monetary penalty. The IRA also generally requires drug manufacturers to provide rebates for Medicare Part B and Part D medicines if the price of a Part B or Part D drug increases faster than the rate of inflation. As of January 2025, under the IRA, the Part D benefit redesign replaced the 70 percent CGDP discount with a 10 percent manufacturer discount for all Medicare Part D beneficiaries that have met their deductible and incurred out of pocket drug costs below a $2,000 threshold and a 20 percent discount for beneficiaries that have incurred out of pocket drug costs above the $2,000 threshold under the new Part D benefit redesign. ManufacturersThe thateffectuation failof a "maximum fair price" pursuant to comply with the IRA mayis bea subjecttechnically tocomplex variousprocess penalties,that including civil monetary penalties, which could be significant. The IRA has and will continue to meaningfully impact our business strategies and those of others in the pharmaceutical industry. The full impact of the IRArelies on ournewly businessdeveloped andsystems thethat pharmaceuticalmay industry, including the implications to us of our or a competitor's product being selected for price setting, remains uncertain.experience
unforeseen disruptions. Manufacturers that fail to comply with the IRA may be subject to various penalties, including civil monetary penalties, which could be significant. The IRA has and will continue to meaningfully impact our business strategies and those of others in the pharmaceutical industry. 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, Baraclude and Orencia for 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. 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 United States, however, such exemptions may be terminated or may not be extended. We remain subject to any current or future pricing mandates implemented outside of the United States, and it is possible that current or future pricing regulations may result in a material impact on our business and results of operations. 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.
In July 2025, the OBBBA was enacted which, among other things, aims to achieve efficiencies in U.S. federal government healthcare spending over the next decade, primarily within Medicaid. We are continuing to assess the full scope of this legislation and its potential commercial implications, and it is possible that these changes may impact our cash flows and results of operations.
We participate in the 340B program, under which we must offer covered outpatient drugs to statutorily defined covered entities at no more than the 340B program “ceiling price”. The expanded utilization of the 340B program in recent years has negatively affected our revenues and profit margins. Additionally, manufacturers who are found to have knowingly and intentionally overcharged 340B program covered entities could be subject to significant monetary penalties. In the past, Celgene had received inquiries from the Health Resources and Services Administration regarding the limited distribution networks for Revlimid, Pomalyst, and Thalomid and compliance with the 340B program. As part of our broader integration strategy and alignment of our distribution model (post our acquisition of Celgene) we had announced that beginning March 1, 2022, we would generally recognize up to two designated 340B program contract pharmacy locations per 340B program hospital that lacks an entity-owned pharmacy. We then updated this policy effective July 1, 2024, to generally recognize up to four contract pharmacy locations per 340B program hospital that lacks an entity-owned pharmacy. Multiple states have enacted laws generally prohibiting manufacturer policies restricting recognition of contract pharmacy arrangements and provide for certain penalties for violations. Such laws have been subject to legal challenges. Whether or how such laws may impact our business remains uncertain. Although we believe that we have complied with, and continue to comply with, all applicable legal requirements, additional legal or legislative changes with respect to the 340B program may cause us to update our approach. Significant changes to our sales or pricing practices with regard to the distribution of drugs under the 340B program, an inability to procure data sufficient to identify duplicate claims associated with the increasing volume of 340B program utilization or any material changes in our U.S. payer channel mix, including the commercialization of future products that may be highly utilized within the 340B program, could have additional adverse effects on our revenues and profitability. In addition, if we are required to pay penalties under the applicable regulations, there would be an adverse effect on our revenues and profitability. For additional information on pricing pressures and other constraints, refer to “Item 1. Business—Pricing, Price Constraints and Market Access.”
Additionally, manufacturers who are found to have knowingly and intentionally overcharged 340B program covered entities could be subject to significant monetary penalties. Over the course of the past few years, Celgene had received inquiries from the Health Resources and Services Administration regarding the limited distribution networks for Revlimid, Pomalyst, and Thalomid and compliance with the 340B program. As part of our broader integration strategy and alignment of our distribution model (post our acquisition of Celgene) we had announced that beginning March 1, 2022, we would generally recognize up to two designated 340B program contract pharmacy locations per 340B program hospital that lacks an entity-owned pharmacy. We then updated this policy effective July 1, 2024, to generally recognize up to four contract pharmacy locations per 340B program hospital that lacks an entity-owned pharmacy. Multiple states have enacted laws generally prohibiting manufacturer policies restricting recognition of contract pharmacy arrangements and provide for certain penalties for violations. Such laws have been subject to legal challenges. Whether or how such laws may impact our business remains uncertain. Although we believe that we have complied with, and continue to comply with, all applicable legal requirements, additional legal or legislative changes with respect to the 340B program may cause us to update our approach. Significant changes to our sales or pricing practices with regard to the distribution of drugs under the 340B program, or any material changes in our U.S. payer channel mix, could have an adverse effect on our revenues and profitability. In addition, if we are required to pay penalties under the applicable regulations, there would be an adverse effect on our revenues and profitability. For additional information on pricing pressures and other constraints, refer to “Item 1. Business—Pricing, Price Constraints and Market Access.”
As is common in the pharmaceutical industry, BMS expects that sales of its branded products like Orencia, Eliquis and Opdivo will decline after the loss of market exclusivity for such products. Consequently, our future success is highly dependent on our pipeline of new products. There is a high rate of failure inherent in the research and development process for new drugs. As a result, there is a high risk that our investments in research programs will not generate financial returns. Compounds or products may appear promising in development but fail to reach market within the expected or optimal timeframe, or at all. We have experienced setbacks and may continue to do so.
In addition, product extensions or additional indications may not be approved. Furthermore, products or indications approved under the U.S. FDA’s Accelerated Approval Program may be contingent upon verification and description of clinical benefit in confirmatory studies and such studies may not be successful. For additional information, refer to "Item 1. Business—Products, Intellectual Property and Product Exclusivity".
Commercialization launch delays are especially common when a product is expected to have a REMS program, as required by the FDA to address significant risk/benefit issues. Certain of our future key products may be required to be distributed in the U.S. through
Commercialization launch delays are especially common when a product is expected to have a REMS program.program, as required by the FDA to address significant risk/benefit issues. Certain of our future key products may be required to be distributed in the U.S. through a REMS program, as described in "Item 1. Business—Marketing, Distribution and Customers". The inability to bring a product to market or a significant delay in the expected regulatory approval and related launch date of a new product could negatively impact our revenues and earnings. In addition, if certain acquired pipeline programs are canceled or we believe their commercial prospects have been reduced, we may recognize material non-cash impairment charges for those programs.programs as we have done in the past. Finally, losing key molecules and intermediaries or our compound library through a natural or man-made disaster or act of sabotage could negatively impact the product development cycle.
We can provide no assurance when or whether any of our products under development will be approved or launched or whether any products, once launched, will be commercially successful. The public announcement of data from our clinical studies, or those of our competitors, or news of any developments related to our, or our competitors’, products or late-stage compounds may cause significant volatility in our stock price and depending on the data, may result in an adverse impact on our business, financial condition or results of operations. If the development of any of our key late-stage product candidates is delayed or discontinued or a clinical study does not meet one or more of its primary endpoints, our stock price could decline significantly and there may be an adverse impact on our business, financial condition or results of operations. As a result, we may experience difficulties in forecasting our future performance and effectively communicating our strategy to investors.
Market exclusivity for our products is based upon patent rights and certain regulatory forms of exclusivity. The scope of our patent rights, if any, varies from country to country and may also be dependent on the availability of meaningful legal remedies in a country. The failure to obtain or maintain patent and other intellectual property rights, or limitations on the use or loss of such rights, could result in a rapid loss of sales for any affected products which could be material to us. In some countries, including certain EU member states, basic patent protections for our products may not exist because certain countries did not historically offer the right to obtain specific types of patents, and/or we (or our licensors) did not file in those countries. In addition, the patent environment can be unpredictable, and the validity and enforceability of patents cannot be predicted with certainty. For example, for Eliquis, 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 and may seek to market generic versions of Eliquis in other EU countries prior to the expiration date of applicable patents and related SPCs. Furthermore, manufacturers of innovative drugs as well as generic drug manufacturers may be able to design their products around our owned or licensed patents and compete with us using the resulting alternative technology. Absent relevant patent protection for a product, once the dataregulatory exclusivity period expires, generic or alternative versions can be approved and marketed.
Generic and biosimilar product manufacturers as well as other groups seeking financial gain are also increasingly seeking to challenge patents before they expire, and we have faced and may continue to face earlier-than-expected competition for any products at any time. Patents covering our key products have been, and are likely to continue to be, subject to validity, enforceability and infringement challenges in patent litigations and post-grant review patent office proceedings. Although we are confident in the strength of our intellectual property rights, it may be possible for generic drug companies to successfully challenge our rights and launch their generic versions of our drugs "at risk" prior to the expiration of our intellectual property rights. For example, following certain adverse judicial decisions in the UK, FinlandUK and Slovakia,Finland, generic manufacturers have begun marketing generic versions of Eliquis in these countries, and may seek to market generic versions of Eliquis in additional countries in Europe, prior to the expiration of our patents, which may lead to additional infringement and invalidity patent actions involving Eliquis patents being filed in various countries in Europe. In addition, in order to avoid the uncertainty and expense of litigation, among other reasons, we may decide to enter into settlements with generic manufacturers that permit generic market entry prior to the expiration of our intellectual property rights. For example, as a result of patent settlements, generic entry for Revlimid in the UK began on January 18, 2022, and in various other European countries on February 18, 2022. Similarly, in the U.S., following patent settlements, certain companies have begun marketing generic lenalidomide pursuant to volume-limitedlicenses, licenses.which Theas licensesof willJanuary 31, 2026, are no longer be volume-limited beginning on January 31, 2026.volume-limited.
In some cases, manufacturers may seek regulatory approval by submitting their own clinical study data to obtain marketing approval or choose to launch a generic product “at risk” before the expiration of the applicable patent(s) and/or before the final resolution of related patent litigation. In addition, some countries are allowing manufacturers to manufacture and sell generic products, which negatively impacts the protections afforded the Company. Lower-priced generics or biosimilars for BMS biologic productsbiologics or competing biologics could negatively impact our volumes and prices.
In addition, both the U.S. Congress and the FDA have taken steps to promote the development and approval of generic drugs and biosimilar biologics, including by providing generic and biosimilar developers a private right of action to obtain sufficient quantities of drug samples from the reference product’s manufacturer in order to conduct testing necessary to obtain approval for generic or biosimilar products. Additionally, in October 2025, the FDA issued new draft guidance to streamline the process of, and accelerate the timeline for, biosimilar development, including by minimizing the requirement for comparative clinical efficacy studies.
In addition, in December 2023, the Biden administration released a proposed framework that for the first time proposed that a drug’s price can be a factor in determining that the drug is not accessible to the public and, therefore, that the government could exercise “march-in rights” and license it to a third party to manufacture. We cannot predict whether the Trump administration will finalize the draft framework or if the government will propose other drug pricing policy changes. If pursued and finalized, these policies could reduce prices and reimbursement for certain of our products and could significantly impact our business and consolidated results of operations.
The future growth of BMS is dependent on the market access, uptake and expansion for marketed brands, new product introductions, new indications, productnew extensionsformulations and co-promotional activities with alliance partners. Competition is keen, and as we lose exclusivity for some of our marketed brands, lower-priced generic products will increasingly penetrate our markets. Generic or biosimilar challenges to our products can also arise at any time, and our patents may not prevent the emergence of generic or biosimilar competition for our products. In some countries, patent protection is significantly weaker than in the U.S. or in the EU; political and social pressure has also pushed legislation and other measures that promote the use of generic and biosimilar products. For additional information, see “—We could lose market exclusivity of a product earlier than expected.”
In addition, we face competition from new products entering the market. New products may have (i) lower prices, (ii) superior efficacy (benefit) or safety (risk) profiles (whether actual or perceived), (iii) technological advantages that may make such products more convenient to use, (iv) better insurance coverage or reimbursement levels, (v) more effective marketing programs and/or other differentiating factors that make it harder for our products to compete. We cannot predict with accuracy the timing or impact of the introduction of competitive products that treat diseases and conditions like those treated by our products and product candidates. Business combinations among our competitors and major third-party payers may also increase competition for our products. If we are unable to compete successfully against our competitors’ products in the marketplace, this could have a material negative impact on our revenues and earnings.
introduction of competitive products that treat diseases and conditions like those treated by our products and product candidates. Business combinations among our competitors and major third-party payers may also increase competition for our products. If we are unable to compete successfully against our competitors’ products in the marketplace, this could have a material negative impact on our revenues and earnings.
Our product supply and related patient access has been, and could in the future be, negatively impacted by difficulties, delays and disruptions in the manufacturing, distribution and sale of our products. Some of the difficulties, delays and disruptions include: (i) product seizures or recalls or forced closings of manufacturing plants; (ii) our failure, or the failure of any of our vendors or suppliers, to comply with cGMP and other applicable regulations or quality assurance guidelines that could lead to manufacturing shutdowns, product shortages or delays in product manufacturing; (iii) manufacturing, quality assurance/quality control, supply problems or governmental approval delays; (iv) the failure of a supplier, including sole source or single source suppliers, to provide us with the necessary raw materials, supplies or finished goods within a reasonable timeframe and with required quality; (v) the failure of a third-party manufacturer to supply us with bulk active or finished product on time; (vi) construction or regulatory approval delays for new facilities or the expansion of existing facilities, including those intended to support future demand for our biologics products; (vii) the failure to meet new and emerging regulations requiring products to be tracked throughout the distribution channels using unique identifiers to verify their authenticity in the supply chain; (viii) other manufacturing or distribution issues, including limits to manufacturing capacity and changes in the types of products produced, such as biologics, physical limitations, labor disputes or shortages, or other business interruptions; (ix) geopolitical factors in a specific country or region, including any new, or changes in or interpretations of existing, trade regulations, including for example, any new tariffs imposed in the jurisdictions in which we operate, or compliance requirements of other legislation; (v) the failure of a supplier, including sole source or single source suppliers, to provide us with the necessary raw materials, supplies or finished goods within a reasonable timeframe and with required quality; (vi) the failure of a third-party manufacturer to supply us with bulk active or finished product on time; (vii) construction or regulatory approval delays for new facilities or the expansion of existing facilities, including those intended to support future demand for our biologics products; (viii) the failure to meet new and emerging regulations requiring products to be tracked throughout the distribution channels using unique identifiers to verify their authenticity in the supply chain; (ix) other manufacturing or distribution issues, including limits to manufacturing capacity and changes in the types of products produced, such as biologics, physical limitations, labor disputes or shortages, or other business interruptions; and (x) disruptions in supply chain continuity, including from market forces, natural disasters, global disease outbreaks or pandemics (including COVID-19),pandemics, acts of war or terrorism or other unforeseeable or unavoidable events that materially impact one or more of our facilities or a critical supplier.
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. We continue to evaluate the impacts of tariffs on our business and results of operations, and it is possible that such tariffs, or future tariffs, may result in a material impact on our business and results of operations.
In addition, manufacturing processes for novel cell-based therapies, such as CAR-T cell therapies, and radiopharmaceutical therapeutics in development are still evolving, and our processes may be more complicated or more expensive than the approaches taken by our current and future competitors. Our ability to source raw materials and supplies used to manufacture our CAR-T cell therapies and to develop consistent and reliable manufacturing processes and distribution networks with an attractive cost of goods could impact future anticipated revenue and gross profit for our CAR-T cell therapies. For our radiopharmaceutical therapeutics, we utilize third-party suppliers that may still be developing appropriate processes, controls, technologies and facilities, particularly for large-scale production. Furthermore, we may face challenges with sourcing raw materials and supplies for clinical and, if approved, commercial manufacturing. Logistical and shipment delays and other factors not in our control could prevent or delay the delivery of our product candidates and marketed products to patients.patients, including for our radiopharmaceutical therapeutics, which have time-limited stability once manufactured. Additionally, we are required to maintain a complex chain of identity and custody with respect to patient material as such material enters into and moves through the manufacturing process. As a result, even slight deviations at any point in the production process for our CAR-T cell therapies or in material used in our CAR-T cell therapies could result in loss of product or regulatory remedial action, which could adversely affect our future anticipated revenues and/or profitability related to our CAR-T cell therapies.
We are currently subject to a number of government laws and regulations and, in the future, could become subject to new government laws and regulations. The costs of compliance with such laws and regulations, or the negative results of non-compliance, could adversely affect our business, our operating results and our financial condition. These laws and regulations control and regulate key aspects of our business, including, but not limited to: (i) market access, pricing controls and discounting; (ii) tax liabilities, returns and payments; (iii) imports and other trade restrictions; (iv) intellectual property protection and enforcement; (v) good practice guidelines and regulations; (vi) accounting standards; (vii) cybersecurity and data protection, storage and privacy, particularly in the EU and the U.S.; (viii) artificial intelligence, machine learning, automated decision-making, data governance, and related technologies; (ix) requirements for reporting payments and other value transfers to healthcare professionals (such as those provided under the Federal Anti-Kickback Statute); and (ixx) compliance with anti-bribery and anti-corruption practices of the U.S. and other countries.
In addition, the U.S. healthcare industry is highly regulated and subject to frequent and substantial changes, including as a result of new judicial or governmental decisions. For example, Congress passed the Food and Drug Omnibus Reform Act in December 2022, which gave the FDA additional authority to require confirmatory trials to be underway at the time of approval and offered an additional enforcement mechanism if sponsors do not complete such studies with due diligence. Additionally, pharmacy benefit manager practices have come under increased scrutiny from U.S. policymakers at the federal and state level, who have proposed legislation intended to address concerns regarding the impact that these intermediaries have on drug pricing and patients’ out of pocket costs. If promulgated, such legislation could have resultant implications, costs or consequences for our business and how we interact with these entities. We cannot predict how other future federal or state legislative or administrative changes relating to healthcare reform will affect our business. For additional information, refer to “Item 1. Business—Government Regulation,” “Item 1. Business—Pricing, Price Constraints and Market Access” and “—Legal matters could negatively affect our business.” Similarly, the legislative and regulatory environment regarding cybersecurity, data protection, storage and privacy is continuously evolving and the subject of significant attention by regulators and private parties globally. Regulators are imposing new cybersecurity and data protection, storage and privacy requirements, including new and greater monetary fines or penalties for privacy violations, and jurisdictions where we operate have passed, or continue to propose, data privacy legislation and or regulations. Failure to comply with these laws could result in significant penalties, including potential exclusion from federal healthcare programs, and reputational harm and could have a material adverse effect on our business and results of operations.
interact with these entities. We cannot predict how other future federal or state legislative or administrative changes relating to healthcare reform will affect our business. For additional information, refer to “Item 1. Business—Government Regulation,” “Item 1. Business—Pricing, Price Constraints and Market Access” and “—Legal matters could negatively affect our business.” Similarly, the legislative and regulatory environment regarding cybersecurity, data protection, storage and privacy is continuously evolving and the subject of significant attention by regulators and private parties globally. Regulators are imposing new cybersecurity and data
protection, storage and privacy requirements, including new and greater monetary fines or penalties for privacy violations, and jurisdictions where we operate have passed, or continue to propose, data privacy legislation and or regulations. Failure to comply with these laws could result in significant penalties, including potential exclusion from federal healthcare programs, and reputational harm and could have a material adverse effect on our business and results of operations.
There is an increased focus by foreign, federal, state, and local regulatory and legislative bodiesbodies, investors and other stakeholders regarding environmental sustainability and social impact policies relating to climate change, regulating greenhouse gas emissions, carbon taxes, emissions trading schemes, sustainability, human rights, inclusion and diversityother policy matters, and disclosure regarding the foregoing, many of which may be ambiguous, inconsistent, dynamic or conflicting. We expect to experience or be subject to increased restrictions, compliance and assurance costs, recurring investments in data gathering and reporting systems, and legal expenses related to such new or changing legal or regulatory requirements, which could increase our operating costs. In addition, we may still be subject to penalties or potential litigation if such laws and regulations are interpreted or applied in a manner inconsistent with our practices.
Moreover, from time to time we establish and publicly announce environmental, social and governance aspirational goals and commitments. Implementation of our environmental, social and governance aspirational goals and initiatives involves risks and uncertainties, requires investments, and depends in part on third-party performance or data that is outside of our control. In addition, some stakeholders may disagree with the Company’s environmental, social and governance aspirational goals, targets or objectives. If we do not meet, are perceived not to meet, or if stakeholders disagree with, our environmental, social and governance aspirational goals, targets or objectives, we risk negative stakeholder reaction, including from proxy advisory services, as well as damage to our brand and reputation, reduced demand for our products, inability to attract and retain employee talent or other negative impacts on our business and operations.
brand and reputation, reduced demand for our products, inability to attract and retain employee talent or other negative impacts on our business and operations.
Pharmaceutical products receive regulatory approval based on data obtained in controlled clinical trials of limited duration. Additional clinical trials, head-to-head studies, real-world data analyses, adverse events reports following the use of our products
overPharmaceutical longerproducts periodsreceive regulatory approval based on data obtained in controlled clinical trials of timelimited duration. Data generated after initial approval and regulatory changes to standards regarding safety, efficacy or labeling may result in product label changes or other measures that could reduce the product’s market acceptance and result in declining revenues. These include additional clinical trials, such as head-to-head studies against alternative or emerging standard of care, studies that generate data in specific populations or identify biomarkers (objective characteristics that can indicate a particular response to a product or therapy) thatas arewell conductedas afterreal-world obtainingdata marketinganalyses approvaland forpost-approval safety surveillance following the use of our products,products andover regulatorylonger changesperiods toof standards regarding safety, efficacy or labeling, may result in product label changes or other measures that could reduce the product's market acceptance and result in declining revenues.time. Sometimes additional information from new studies identifies a portion of the patient population that may be non-responsive to a medicine or would be at higher risk of adverse reactions and labeling changes based on such studies may limit the patient population. The studies providing such additional information may be sponsored by us, but they could also be sponsored by competitors, insurance companies, government institutions, MCOs, scientists, investigators or other interested parties. While additional safety and efficacy information from such studies assist us and healthcare providers in identifying the best patient population for each product, it can also negatively impact our operating results. New information added to a product’s label can affect its risk-benefit profile, leading to potential voluntary or mandatory recalls, withdrawals or declining revenue, as well as legal claims, including product liability, consumer fraud or other claims. For example, in November 2023, the FDA announced that it was investigating the risk of T-cell malignancies in patients who received treatment with CAR-T cell therapy, noting that the overall benefits of CAR-T cell therapy products continue to outweigh their potential risks for their approved uses. In January 2024, the FDA determined that safety labeling changes were needed for approved CAR-T cell therapies, including a “boxed warning” about the possible risk of T-cell malignancies in patients treated with CAR-T cell therapy. Additionally, certain study results, especially from head-to-head studies, could affect a product’s formulary listing, which could also adversely affect revenues.
Third parties may illegally distribute and sell counterfeit versions of our products, which do not meet our rigorous manufacturing and testing standards.standards and often do not contain the correct ingredients. A patient who receives a counterfeit drug or a product diverted from its authorized market may be at risk for a number of dangerous health consequences. Our reputation and business could suffer harm as a result of counterfeit drugs sold under our brand name or diverted products. The prevalence of counterfeit medicines is an industry-wide issue due to a variety of factors, including the adoption of e-commerce, greatly enhancing consumers’ ability to obtain prescriptions and other medical treatments via the internet in lieu of traditional brick and mortar pharmacies. The internet exposes patients to greater risk as it is a preferred vehicle for dangerous counterfeit offers and scams because of the anonymity it affords counterfeiters.illegal traders and counterfeiters, and its use can result in the circumvention of controls designed to protect patients.
Thefts of inventory at warehouses, plants or while in-transit, which are then not properly stored and are later sold through unauthorized channels,channels that do not adhere to customary supply chain standards, could adversely impact patient safety, our reputation and our business. In addition, diversion of products from their authorized market into other channels may result in reduced revenues and negatively affect our profitability.
We use social media to communicate Company news and events. The inappropriate and/or unauthorized use of social media could cause brand damage or information leakage and may give rise to liability, including from the improper promotion of a product or the improper collection and/or dissemination of personally identifiable information from employees, patients, healthcare professionals or other stakeholders. In addition, negative or inaccurate posts or comments about us on any social networking website could damage our reputation, brand image and goodwill and may cause significant volatility in our stock price. Further, the disclosure of non-public Company-sensitive information by our workforce or others, whether intentional or unintentional, through social media and other messaging channels could lead to loss of trade secrets or other intellectual property, as well as the Company’s commercially sensitive information.
We rely extensively on information technology systems, networks and services, including internet sites, data hosting and processing facilities and tools, physical security systems and other hardware, software and technical applications and platforms, some of which are managed, hosted, provided by and/or used for third parties or their vendors, to assist in conducting our business. We have faced, and will continue to face, risks of incidents, whether through cyber attacks or cyber intrusions through the Cloud, the Internet, phishing attempts, ransomware and other forms of malware, computer viruses, email attachments, extortion, exfiltration and other scams. Although we make efforts to maintain the security and integrity of our information technology systems and data, these systems and the proprietary, confidential and personal information that resides on or is transmitted through them, are subject to the risk of a cybersecurity incident or disruption, and there can be no assurance that our security efforts and measures, and those of our third-party vendors, will prevent breakdowns or incidents to our or our third-party vendors’ systems, which could adversely affect our business strategy, results of operations, or financial condition. Cybersecurity risks continue to develop, including as a result of threat actors increasingly targeting employees and supply chains and geopolitical tensions leading to an increase in sabotage, espionage and cyber attacks. As the cyber-threat landscape evolves, these attacks are growing in frequency, sophistication and intensity, and due to the nature of some of these attacks, there is also a risk that they may remain undetected for a period of time. A significant breakdown, invasion, corruption, destruction or interruption of critical information technology systems, including artificial intelligence programs that we utilize, or leak, theft or misuse of proprietary, confidential or personal information could negatively impact operations. There can be no assurance that our continuing efforts will prevent breakdowns or incidents to our or our third-party providers’ systems or databases that could adversely affect our business. Under certain circumstances, such incidents when detected could require disclosure to government authorities and/or regulators and could require notification to impacted individuals, and any such incident could result in material financial, legal, business and reputational harm to us. Further, although we maintain insurance coverage designed to transfer certain cybersecurity incident costs, there is a risk this insurance would be insufficient to cover the costs of the incident, including due to coverage limits or insurance exclusions.
to the nature of some of these attacks, there is also a risk that they may remain undetected for a period of time. A significant breakdown, invasion, corruption, destruction or interruption of critical information technology systems or leak or theft of proprietary, confidential or personal information could negatively impact operations. There can be no assurance that our continuing efforts will prevent breakdowns or incidents to our or our third-party providers’ systems or databases that could adversely affect our business. Under certain circumstances, such incidents when detected could require disclosure to government authorities and/or regulators and could require notification to impacted individuals, and any such incident could result in material financial, legal, business and reputational harm to us. Further, although we maintain insurance coverage designed to transfer certain cybersecurity incident costs, there is a risk this insurance would be insufficient to cover the costs of the incident, including due to coverage limits or insurance exclusions.
In addition, we face certain risks as we seek to leverage artificial intelligence programs and machine learning (“AI”) to optimize productivity and efficiency in various aspects of the organization. For example, flawed algorithms and/or biased, incomplete or inaccurate data used in AI programs may result in deficient AI-generated content. Additionally malfunctions or outages of these systems, certain of which are managed, hosted or provided by third parties, may result in operational disruptions, data loss, or inaccurate content. The regulatory landscape related to AI remains uncertain, and we may be required to devote significant resources to comply with developing laws and address ethical concerns. Our competitors may also develop or adopt more effective AI technologies, resulting in more efficient operations and putting us at a competitive disadvantage. These risks may result in an adverse impact on our business, financial condition or results of operations.
We derive a majority of our revenue and earnings from several key products. We expect that Eliquis, Opdivo, OrenciaOpdivo Qvantig, Orencia, Reblozyl and Yervoy will represent a significant percentage of our 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 our earnings and cash flows. For additional information, see “—We could lose market exclusivity of a product earlier than expected.”
We have entered into several arrangements which entitle us to potential royalties from third parties for out-licensed intellectual property, commercialization rights and sales-based contingent proceeds related to the divestiture of businesses. In many of these arrangements we have minimal, if any, continuing involvement that contributes to the financial success of those activities. Royalties have continued to represent a significant percentage of our pretax income, including royalties related to the divestiture of our diabetes business (including the transfer of certain future royalty rights pertaining to Amylin, Onglyza* and Farxiga* product sales), out-licensed intellectual property and the Merck patent infringement settlement. Pretax income generated from royalties was approximately $2.4$2.7 billion in 2024.2025. Our pretax income could be adversely affected as the royalty streams decline in future periods. For example, (i) royalties related to Keytruda* decreased from 6.5% to 2.5% on January 1, 2024 and are expected to terminate on December 31, 2026, and(ii) royalties related to Tecentriq* are expected to terminate on December 31, 2026.2026, Inand addition,(iii) royalties related to the divestiture of our royalties from our divested diabetes business,business specifically Amylin, Farxiga and Onglyza, terminateterminated on December 31, 2025.
Our strategy is focused on delivering innovative, transformational medicines to patients in a focused set of disease areas. To support future revenue growth and maintain an adequate pipeline, we have acquired, or in-licensed, a number of assets, and we expect to continue to support our pipeline with compounds or products obtained through licensing and acquisitions. Competition among pharmaceutical companies for acquisition and product licensing opportunities is intense, and we may not be able to locate suitable acquisition targets or licensing partners at reasonable prices, or successfully execute such transactions. If we are unable to consistently maintain an adequate pipeline, whether through internal R&D programs or transactions with third parties or if we are unable to support and grow our marketed products, successfully execute the launches of newly approved products, advance our late-late-stage pipeline, manage change from our operating model evolution or manage our costs effectively, our operating results and financial condition could be negatively impacted.
stage pipeline, manage change from our operating model evolution or manage our costs effectively, our operating results and financial condition could be negatively impacted.
We may not be successful in separating underperforming or non-strategic assets, and gains or losses on the divestiture of, or lost operating income from, such assets may affect our earnings. Our divestitures also may result in continued financial exposure to the divested businesses, such as through guarantees or other financial arrangements, continued supply and services arrangements, or potential litigation, following the transaction. Under these arrangements, nonperformance by us could result in obligations being imposed on us that could have a material adverse effect on our competitive position, cash flows, results of operations, financial condition or reputation.
imposed on us that could have a material adverse effect on our competitive position, cash flows, results of operations, financial condition or reputation.
If the execution or implementation of acquisitions, divestitures, alliances, joint ventures and other portfolio actions is not successful, it could adversely impact our financial condition, cash flows and results of operations. Moreover, due to the substantial amount of debt that we incurred to finance the cash portion of certain of our acquisitions, including most recently the Celgene, MyoKardia, Mirati, Karuna and RayzeBio acquisitions, there can be no assurance of when we will be able to expand our business development capacity. Although we arehave committedrecently taken measures to reducingreduce our debt, pursuing strategic transaction opportunities in the future may require us to obtain additional equity or debt financing, and could result in increased leverage and/or a downgrade of our credit ratings.
Failure to attract and retain a highly qualified workforce or to maintain our workplace culture could affect our ability to successfully develop and commercialize products.
Our success and execution of our strategy is largely dependent on our continued ability to (i) attract and retain highly qualified scientific, technical and management workforce, including people with expertise in clinical R&D, governmental regulation and commercialization, and (ii) in connection withmaintain our acquisitions,workplace integrate corporate culturesculture and maintain employee morale. We are facing increasingface competition for a limited pool of qualified individuals from numerous pharmaceutical and biotechnology companies, universities, government entities, research institutions, companies seeking to enter the healthcare space, and companies in other industries. Additionally, we periodically adjust our personnel needs in response to changing macroeconomic conditions, market opportunities, management changes, acquisitions, cost levels and other internal and external considerations, which may adversely impact our workplace culture and ability to retain and incentivize employees. We cannot be sure that we will be able to attract and retain quality talent or that the costs of doing so will not materially increase.
Our acquisitionsCertain of Celgene,our MyoKardia,acquisitions, including most recently the Mirati, Karuna and RayzeBio acquisitions, increased the amount of our debt resulting in additional interest expense, and we may incur more debt to finance future acquisitions. ThisAlthough we have recently taken measures to reduce our debt, this could reduce our financial flexibility to continue capital investments, develop new products and declare future dividends. For example, following the December 2023 announcements of previous acquisitions, Standard & Poor’s downgraded BMS’s long term-credit rating from A+ to A (with a stable long-term credit outlook).
Global economic and political risks pose significant challenges to a company’s growth and profitability and are difficult to mitigate. We generated approximately 29% of our revenues outside of the U.S. in 2024. As such, a global economic downturn could create or amplify a variety of risks to our business and could negatively affect our growth. In addition, uncertainty in the credit and capital
Global economic and political risks pose significant challenges to a company’s growth and profitability and are difficult to mitigate. We generated approximately 31% of our revenues outside of the U.S. in 2025. As such, a global economic downturn could create or amplify a variety of risks to our business and could negatively affect our growth. In addition, uncertainty in the credit and capital markets could impact our growth strategy. Our revenues, earnings and cash flow are also exposed to risk from a strengthening U.S. dollar and global inflation, including in the U.S. If our operating costs were to significantly increase, whether as a result of rising inflation rates, wage increases or other factors, it could adversely affect our revenues and profitability. We also have exposure to customer credit risks in Europe, South America and other markets including from government-guaranteed hospital receivables in markets where payments are not received on time. We have significant operations in Europe, including for manufacturing and distribution. The results of our operations could be negatively impacted by any member country exiting the eurozone monetary union or EU.
Additionally, our business and operations may be adversely affected by political volatility, conflicts or crises in individual countries or regions, including terrorist activities or war and pandemics or epidemics. The COVID-19 pandemic affected demand for some of our products driven by lower patient starts and visits, and we would expect any future pandemics to have a similar effect. In addition, while we did not experience any significant manufacturing or supply issues due to COVID-19, it is possible that we could experience these issues in response to future pandemics. For instance, we may experience scarcity of certain raw materials and components as a result of the influx of pandemic related vaccine orders receiving priority treatment from vendors. Furthermore, a future epidemic or pandemic could create material staffing shortages at our manufacturing sites which could disrupt the supply of our products. It is also possible that we may experience supply chain interruptions as a result of quarantines, shelter-in-place and other governmental orders and policies, travel restrictions, airline and cargo capacity and route reductions. We may also experience delays in the initiation and enrollment of patients in our clinical trials as a consequence of any future pandemic. We may not be able to fully mitigate these delays, which could negatively impact the timing of our pipeline development programs and expected future revenues and/or cash flows. A prolonged clinical trial delay could potentially have a significant negative effect on our business, particularly if new competitive products enter the market or clinical trial results for our competitors’ products affect the value proposition for our product. Any such delays or difficulties in clinical development could also potentially lead to a material impairment of our intangible assets, including the $23.3 billion of other intangible assets as of December 31, 2024.
competitive products enter the market or clinical trial results for our competitors’ products affect the value proposition for our product. Any such delays or difficulties in clinical development could also potentially lead to a material impairment of our intangible assets, including the $19.1 billion of other intangible assets as of December 31, 2025.
The declaration, amount and timing of any dividends fall within the discretion of our Board. The Board’s decision will depend on many factors, including our financial condition, earnings, capital requirements, debt service obligations, industry practice, legal requirements, regulatory constraints and other factors that our Board may deem relevant. A reduction or elimination of our dividend payments or dividend program could adversely affect our stock price. In addition, we could, at any time, decide not to buy back any more shares in the market, or reduce the number of shares repurchased under our share repurchase program, which could also adversely affect our stock price. The IRA imposes a non-deductible 1% excise tax on our net repurchases of shares after December 31, 2022. The imposition of the excise tax on repurchases of our shares may increase the cost to us of making repurchases and may cause our Board to reduce the number of shares repurchased pursuant to our share repurchase program.
Our amended bylaws provide that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware will be, to the fullest extent permitted by law, the sole and exclusive forum for any (i) derivative action or proceeding brought on our behalf, (ii) action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers or other employees to us or our stockholders, creditors or other constituents, (iii) action asserting a claim arising pursuant to any
Our amended bylaws provide that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware will be, to the fullest extent permitted by law, the sole and exclusive forum for any (i) derivative action or proceeding brought on our behalf, (ii) action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers or other employees to us or our stockholders, creditors or other constituents, (iii) action asserting a claim arising pursuant to any provision of the General Corporation Law of the State of Delaware, our amended and restated certificate of incorporation or our amended bylaws or (iv) action asserting a claim against us or any of our directors, officers or other employees governed by the internal affairs doctrine; provided, however, that, in the event that the Court of Chancery of the State of Delaware lacks jurisdiction over any such action or proceeding, the sole and exclusive forum for such action or proceeding will be another state or federal court of the State of Delaware. Our bylaws also provide that any person or entity purchasing or otherwise acquiring or holding any interest in shares of our capital stock will be deemed to have notice of and consented to this forum selection provision.
Nevertheless, this forum selection provision in our bylaws may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or any of our directors, officers and other employees, which may discourage lawsuits with respect to such claims, although our stockholders will not be deemed to have waived our compliance with federal securities laws and the rules and regulations thereunder. In addition, stockholders who do bring a claim in the Court of Chancery in the State of Delaware could face additional litigation costs in pursuing any such claim, particularly if they do not reside in or near Delaware. While we believe the risk of a court declining to enforce the forum selection provision contained in our amended bylaws is low, if a court were to find the provision inapplicable to, or unenforceable in respect of, one or more of the specified types of actions or proceedings, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business, operating results and financial condition.
face additional litigation costs in pursuing any such claim, particularly if they do not reside in or near Delaware. While we believe the risk of a court declining to enforce the forum selection provision contained in our amended bylaws is low, if a court were to find the provision inapplicable to, or unenforceable in respect of, one or more of the specified types of actions or proceedings, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business, operating results and financial condition.
Management's Discussion & Analysis (MD&A)
Largest changes
In oncology, we are focused on extending and strengthening our leadership in IO, as well as diversifying beyond IO.see in full comparisonTheDuringacquisition2025, we entered into a global strategic collaboration with BioNTech for the co-development and co-commercialization ofRayzeBio,pumitamig (BNT327/BMS986545), aleaderpotentially 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 inthe field ofradiopharmaceuticalsforassolidatumornewoncology,oncologyprovided usmodality with opportunities to advance RYZ101,a late-stage asset, an investigational new drug engineRYZ401 andin-house manufacturing capabilities.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 withgolcadomide.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-classpotential.potential, including in vivo CAR-T cell therapies. We are investigating arlo-cel in pivotal studies targeting multiple myeloma and advancing development for zola-cel (CD19-targetedNEX-T,NEX-T), anoptimizedasset aimed at resetting the immune system, in autoimmune diseases. We are exploringCD19-targeted NEX-T'szola-cel's potential in multiple disease areas, includingsystemicSLE,lupus erythematosus, MS,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, includesthree Phase IIIregistrational trialsfor milvexianin atrialfibrillation,fibrillation and secondary stroke preventionandforacutemilvexian.coronary syndrome. Lastly in neuroscience, with the addition of Cobenfy,Lastly, we have a growing, diverse neuroscience pipeline that includesaseveralrangeongoingofPhaseinvestigationalIIItherapies that are being studied for their disease-modifying potentialstudies as well ascriticalseveralsymptomaticinvestigationalrelief.programsTogetheraimedwith our proven track record, rapidlyat advancingpipelinenovelandtherapeuticincreasingapproachesuseacrossofneurologicalartificial intelligence, we are increasing our R&D productivity, enabling us to identify more high-quality candidates and increase their probability of reaching patients in need.diseases.
“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 vivo CAR 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) acqui …”see in full comparison
“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. …”see in full comparison
Thesee in full comparison$8.27$7.87decreasechange in GAAP EPS in20242025 was primarilydrivenduebytoa one-time, non-deductiblelower Acquired IPRDcharge resulting from the Karuna asset acquisition and SystImmune collaboration, which impacted full-year GAAP EPS by approximately $6.28 andcharges, the impact of certain specified items,primarilyincluding lower amortization of acquired intangible assets and lower intangible assetimpairments.impairment charges, and cost savings from our ongoing strategic productivity initiative in 2025. After adjusting for specified items, the$6.36$5.00decreaseincrease in non-GAAP EPS was primarily due to the aforementioned lower Acquired IPRD charges andhighercostinterestsavingsexpensefrompartiallyouroffsetongoingbystrategichigherproductivityrevenues.initiative.
•Litigation and other settlements includes amounts related to a pricing, sales and promotional practicessee in full comparisondisputesdispute and a securities litigationmatters, partially offset by income from the Eisai collaboration terminationmatter in2024.2025. Refer to "Item 8. Financial Statements and Supplementary Data—Note5.20.OtherLegal(Income)/Expense, Net." LitigationProceedings andotherContingencies"settlementsforinmore2023 include $384 million of income related to the AZ settlement and $400 million of income related to the Nimbus' TYK2 program change of control provision, partially offset by $322 million expense recorded in connection with the BeiGene settlement.information.
“The effective tax rate for 2023 was primarily impacted by (i) a $656 million deferred income tax benefit following the receipt of a non-U.S. tax ruling regarding the deductibility of a statutory impairment of subsidiary investments, (ii) higher tax benefits attributed to foreign currency on net operating loss and other carryforwards, and (iii) a $193 million valuation allowance reversal related to unrealized equity investment losses. …”see in full comparison
Full comparison: every changed paragraph (128)
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 20242025 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.
In 2025, we have achieved multiple regulatory approvals across our portfolio, including the: (i) approval of Breyanzi for adults with relapsed or refractory FL and MCL in the EU, (ii) approval of Camzyos for the treatment of symptomatic obstructive HCM in Japan, (iii) approval of Opdivo + Yervoy as a first-line treatment of adult patients with unresectable or advanced HCC in both the U.S. and the EU, (iv) approval of Opdivo + Yervoy for 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 Opdivo as a perioperative regimen for resectable high risk NSCLC in the EU, (vi) approval of Opdivo Qvantig for 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, Breyanzi and 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 vivo CAR 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.
In 2024, we achieved multiple clinical and regulatory milestones across our portfolio including (i) approvals for Breyanzi in the U.S. and Japan for adults with relapsed or refractory FL and in the U.S. for adults with relapsed or refractory CLL/SLL and MCL; (ii) Reblozyl's expanded approval to include the first-line treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk MDS in the EU and Japan; (iii) FDA approval of Opdivo Qvantig injection for subcutaneous use in most previously approved adult solid tumor Opdivo indications; (iv) FDA approval of Opdivo for the treatment of adult patients with resectable NSCLC, in combination with platinum-doublet chemotherapy, followed by single-agent Opdivo as adjuvant treatment after surgery; and (v) FDA approval and subsequent launch of Cobenfy for the treatment of schizophrenia in adults.
In 2024, we completed the following acquisitions: (i) Karuna, a biopharmaceutical company in the area of developing and delivering medicines, including Cobenfy, for psychiatric and neurological conditions; (ii) RayzeBio, a clinical-stage radiopharmaceutical therapeutics company with a pipeline of potentially first-in-class and/or best-in-class drug development programs; and (iii) Mirati, a commercial stage targeted oncology company, with a commercialized medicine, Krazati, and clinical programs in development. We also entered into a strategic collaboration with SystImmune, to co-develop and co-commercialize izalontamab brengitecan (iza-bren or BL-B01D1), a bispecific topoisomerase inhibitor-based anti-body drug conjugate. Refer to “Item 8. Financial Statements and Supplementary Data—Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements” for additional information.
Revenues were relatively flat in 2025. Demand increased by 7%, primarily driven byacross the Growth Portfolio and for Eliquis, partiallywhich was offset by genericthe erosionimpact inof 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 20252026 primarily due to Revlimid, SprycelRevlimid and for Pomalyst outsidein the U.S.
The $8.27$7.87 decreasechange in GAAP EPS in 20242025 was primarily drivendue byto a one-time, non-deductiblelower Acquired IPRD charge resulting from the Karuna asset acquisition and SystImmune collaboration, which impacted full-year GAAP EPS by approximately $6.28 andcharges, the impact of certain specified items, primarilyincluding lower amortization of acquired intangible assets and lower intangible asset impairments.impairment charges, and cost savings from our ongoing strategic productivity initiative in 2025. After adjusting for specified items, the $6.36$5.00 decreaseincrease in non-GAAP EPS was primarily due to the aforementioned lower Acquired IPRD charges and highercost interestsavings expensefrom partiallyour offsetongoing bystrategic higherproductivity revenues.initiative.
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 canhave negatively impacted, and may continue to negatively impact our results of operations (including intangible asset impairment charges), operating cash flow, liquidity and financial flexibility. The IRA directs (i) the federal government to “negotiate” prices for select high-cost Medicare Part D (beginning in 2026) and Part B (beginning in 2028) drugs that are more than nine years (for small-molecule drugs) or 13 years (for biological products) from their initial FDA approval, (ii) manufacturers to pay a rebate for Medicare Part B and Part D drugs when prices increase faster than inflation and (iii) the formation of the Part D Manufacturer Program which replaced the Part D CGDP and established a $2,000 cap for out-of-pocket costs for Medicare beneficiaries as of January 2025, with manufacturers being responsible for 10% of costs up to the $2,000 cap and 20% after that cap is reached. 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 JanuaryNovember 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 PomalystOrencia as a medicine subject to "negotiation" for government-set prices beginning in 2027.2028. It is possible that more of our products could be selected in future years,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, Baraclude and Orencia for 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.
In addition, in December 2023, the Biden administration released a proposed framework that for the first time proposed that a drug’s price can be a factor in determining that the drug is not accessible to the public and, therefore, that the government could exercise “march-in rights” and license it to a third party to manufacture. We cannot predict whether the Trump administration will finalize the draft framework or if the government will propose other drug pricing policy changes. If pursued and finalized, these policies could reduce prices and reimbursement for certain of our products and could significantly impact our business and consolidated results of operations.
Additionally, in connection with the IRA, the following changes have been made to U.S. tax laws, including (i) a 15% minimum tax that generally applies to U.S. corporations on adjusted financial statement income beginning in 2023 and (ii) a non-deductible 1% excise tax provision on net stock repurchases after December 31, 2022. Furthermore, countries are in the process of enacting changes to their tax laws to implement the agreement by the OECD to establish a global minimum tax. 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.earnings”.
Significant Product and Pipeline Approvals
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.
Our R&D strategy is intended to ensure that we support scientific innovation, bringing first-in class and/or best-in-class medicines to patients at an accelerated speed in our core therapeutic areas, as we leverage our differentiated research platforms, including radiopharmaceutical therapy, targeted protein degradation and cell therapy. We have a broad mid- to late-stage pipeline of ongoing Phase II and Phase III programs across our core therapeutic areas. Over the next 24 months, we expect a number of registrational data readouts with the potential to deliver 10 or more new medicines and multiple additional indications over the next five years.
In oncology, we are focused on extending and strengthening our leadership in IO, as well as diversifying beyond IO. TheDuring acquisition2025, we entered into a global strategic collaboration with BioNTech for the co-development and co-commercialization of RayzeBio,pumitamig (BNT327/BMS986545), a leaderpotentially 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 the field of radiopharmaceuticals foras solida tumornew oncology,oncology provided usmodality with opportunities to advance RYZ101, a late-stage asset, an investigational new drug engineRYZ401 and in-house manufacturing capabilities.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.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.potential, including in vivo CAR-T cell therapies. We are investigating arlo-cel in pivotal studies targeting multiple myeloma and advancing development for zola-cel (CD19-targeted NEX-T,NEX-T), an optimized asset aimed at resetting the immune system, in autoimmune diseases. We are exploring CD19-targeted NEX-T'szola-cel's potential in multiple disease areas, including systemicSLE, lupus erythematosus, MS,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 three Phase III registrational trials for milvexian in atrial fibrillation,fibrillation and secondary stroke prevention andfor acutemilvexian. coronary syndrome. Lastly in neuroscience, with the addition of Cobenfy,Lastly, we have a growing, diverse neuroscience pipeline that includes aseveral rangeongoing ofPhase investigationalIII therapies that are being studied for their disease-modifying potentialstudies as well as criticalseveral symptomaticinvestigational relief.programs Togetheraimed with our proven track record, rapidlyat advancing pipelinenovel andtherapeutic increasingapproaches useacross ofneurological artificial intelligence, we are increasing our R&D productivity, enabling us to identify more high-quality candidates and increase their probability of reaching patients in need.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, Yervoy and OpdualagOpdualag, and receivedhave FDAexpanded approvalour forleadership in the area with the addition of Opdivo QvantigQvantig. inIn December 2024 for multiple indications at launch.hematology, Reblozyl, in first-line MDS-associated anemia, continues to drive market share withinin the largerfirst first-lineline RS negative population. We have an ongoing registrational trial to potentially expand into chronic anemia associated with myelofibrosis. In cell therapy, we achieved important approvals for Breyanzi for patients with relapsed or refractory CLL/SLL, FLRS-positive and MCL,RS-negative makingsettings Breyanziin the CAR-TU.S., celland therapy available to treat the broadest array of B-cell malignancies. Inin cardiovascular diseases, Camzyos continues to provide benefits to patients with oHCM,oHCM. withAdditionally, in cell therapy, we continue to expand the potentialrange expansionof opportunityB-cell intomalignancies nHCM.treated by Breyanzi. Finally, in immunology and neuroscience, werespectively, launchedregistrational Cobenfystudies are ongoing for the treatment of schizophreniaSotyktu in adults.systemic Registrationallupus studieserythematosus and Sjögren's disease and are ongoing or planned for Cobenfy in Adjunctive Schizophrenia, 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 expectedcontinue to realize cost savings of approximately $1.5 billion by the end of 2025, which is primarily being reinvested to fund innovation and drive growth. We have expanded our strategic productivity initiative and we now expect to deliverrealize approximately $2.0 billion in additional annual cost savings by the end of 2027.2027 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. Through our Environmental, Social and Governance (ESG) strategy,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.
(a) Beginning in 2024, Puerto Rico revenues are presented as part of International revenues to align with management's review of the Company's financial results. Prior period amounts have been recast to conform to the current presentation.
(ba) Other revenues include royalties and alliance-related revenues for products not sold by our regional commercial organizations.organizations, including royalties received from Merck on Winrevair*.
(cb) Foreign exchange impacts were derived by applying the prior period average currency rates to the current period revenues.
•U.S. revenues increaseddecreased 9%2% in 20242025 primarily due toreflecting higher demand withinacross the Growth Portfolio, Eliquis,Portfolio and Pomalystfor Eliquis, partially offset by genericthe erosionimpact of generics on Revlimid, Sprycel and Abraxane. Additionally, U.S. revenues were impacted by higher government channel rebates in the Legacy Portfolio.2025. Average net selling prices decreased by 1%4% in 20242025 compared to 2023.2024.
International
•International revenues increased 5% in 2024 increased 1%2025 primarily due to higher demand withinacross the Growth Portfolio,Portfolio and for Eliquis, partially offset by generic erosion within the remainder of the Legacy PortfolioPortfolio. andExcluding foreign exchange impacts. The negative foreign exchangethe impacts of 5%foreign wasexchange, primarilyinternational attributedrevenues toincreased devaluation of the Argentine peso, which was partially offset by inflation-related local currency price increases.3%.
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 and $134 million for 2023.2024. The reductions to provisions in both2025 yearsprimarily wererelated drivento bylower 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. Non-U.S. GTN adjustments percentage increased primarily due to continued pricing pressures. We expect to experience additional GTN pressures during the first quarter of 2025 as a result of Medicare Part D redesign, particularly for Eliquis and certain other products.
(a) Includes Augtyro, Onureg, Inrebic, Nulojix, Empliciti and royalty revenues.revenues, including royalties received from Merck on Winrevair*.
(c) Includes international and other.
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+Yervoy regimen also is approved in multiple markets for the treatment of NSCLC, melanoma, MPM, RCC, CRCCRC, HCC and various gastric and esophageal cancers.
•U.S. revenues increased 2% in 2024 primarily due to higher average net selling prices, partially offset by lower demand.
•International revenues increased 5% in 2024 primarily due to higher demand for core indications and additional indication launches and higher average net selling prices, partially offset by foreign exchange impact of 9%. Excluding foreign exchange impacts, revenues increased 14%.
Orencia (abatacept) — a fusion protein indicated for adult patients with moderate to severe active RA and PsA. It has indications for (i) reducing signs and symptoms in certain pediatric patients with moderately to severely active polyarticular JIA and (ii) for the treatment of aGVHD, in combination with a calcineurin inhibitor and methotrexate.
•U.S. revenues increased 2%10% in 20242025, primarily due to higher demand,demand partiallyand offset by lowerhigher average net selling prices.
•International revenues increased 2%5% in 20242025, primarily due to higher demand,demand partiallyfor offsetadditional byindication launches and foreign exchange impactimpacts of 8%.1%. Excluding foreign exchange impacts, revenues increased 10%.4%.
Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) — a subcutaneously administered PD-1 inhibitor indicated for most previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy combination 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%.
Yervoy (ipilimumab) — a CTLA4 immune checkpoint inhibitor. Yervoy is a monoclonal antibody for the treatment of patients with unresectable or metastatic melanoma. The Opdivo+Yervoy regimen is approved in multiple markets for the treatment of NSCLC, melanoma, MPM, RCC, CRCCRC, HCC and esophageal cancer.
•International revenues increased 8% in 2024 primarily due to higher demand as a result of additional indication launches and core indications, partially offset by foreign exchange impacts of 7%. Excluding foreign exchange impacts, revenues increased 15%.
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.
•U.S. revenues increased 80% in 2024 primarily due to higher demand.
•International revenues increased 61%15% in 20242025, primarily due to higher demand,demand partially offset byand foreign exchange impacts of 4%.2%. Excluding foreign exchange impacts, revenues increased 65%.14%.
•BMS is not aware of a Yervoy biosimilar 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. Reblozyl is 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%.
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, and 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.
•U.S. revenues increased 95% in 2024 primarily due to higher demand enabled by expanded manufacturing capacity, new indication launches and higher average net selling prices.
•International revenues increased 156% in 2024 primarily due to higher demand, partially offset by foreign exchange of 6%. Excluding foreign exchange impacts, revenues increased 162%.
Camzyos (mavacamten) — aan oral cardiac myosin inhibitor indicated for the treatment of adults with symptomatic oHCM to improve functional capacity and symptoms.
•International revenues increased more than 200% in 2025, primarily due to higher demand driven by launches in new markets.
•U.S. revenues increased 26% in 2024 primarily due to higher demand, partially offset by lower average net selling prices.
•InternationalU.S. revenues increaseddecreased 42%3% in 20242025, primarily due to higherlower demand.
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 four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-cyclic ADP ribose hydrolase monoclonal antibody.
What changed in the latest 10-Q
Risk Factors
There have been no material changes from the risk factors disclosed in the Company's 2025 Form 10-K.
No wording changes found in this section.
Full comparison: every changed paragraph (0)
Management's Discussion & Analysis (MD&A)
Largest changes
As ofsee in full comparisonMarchJune31,30, 2026 and December 31, 2025, we had a five-year $5.0 billion revolving credit facility, which is extendable annually by one year with the consent of the lenders. In January 2026, we extended the termination date of the credit facility from January 2030 to January 2031. The facility provides for customary terms and conditions with no financial covenants and is used to provide backup liquidity for the Company's commercial paper borrowings. No borrowings were outstanding under the revolving credit facility as ofMarchJune31,30, 2026 and December 31, 2025.
Thesee in full comparison$0.11increase in GAAP EPS of $0.98 and $1.08 for thefirstsecond quarter of 2026 and year-to-date, respectively, was primarily due to a one-time Acquired IPRD charge in 2025 and the impact of certain specified items, including lower amortization of acquired intangible assets, and higher revenues in 2026, partially offset byhigher IPRD impairment charges in 2026 andthe expiry of royalty income on diabetes products at the end of 2025. After adjusting for specified items, the$0.22 decreaseincrease in non-GAAP EPS of $0.58 and $0.36 for the second quarter of 2026 and year-to-date, respectively, was primarily due to the aforementioned Acquired IPRD charge and higher revenues, partially offset by the expiry of royalty income on diabetesproducts at the end of 2025.products.
see in full comparisonDuring the first quarter ofIn 2026, we made meaningful progress advancing our pipeline, highlighted by: (i)positive interim Phase III results from the SUCCESSOR‑2 study of oral mezigdomide in RRMM, (ii) positive Phase III results from the SCOUT-HCM trial of Camzyos in adolescents with symptomatic oHCM, (iii) positive top‑line results from a Phase II trial for Reblozyl in adults with Alpha (α)-Thalassemia, (iv) positive interim top‑line results from a Phase III trial conducted in China for iza-bren in previously treated unresectable locally advanced or metastatic TNBC, and (v)FDA acceptance of our NDA for iberdomide incombinationRRMM withstandardatherapyPDUFA date of August 17, 2026; (ii) FDA acceptance of our NDA for mezigdomide in RRMM with a PDUFA date of May 13, 2027; (iii) positive interim Phase II results from the ROSETTA Lung-02 study of pumitamig in patients withRRMM.previously untreated advanced NSCLC; (iv) positive interim results from two Phase III studies conducted in China for iza-bren in heavily pretreated, unresectable locally advanced or metastatic TNBC and recurrent or metastatic ESCC; and (v) FDA acceptance of our sNDA for Camzyos in adolescents with symptomatic oHCM with a PDUFA date of September 30, 2026. Additionally, Sotyktu was approved in the U.S. and EU for the treatment of adults with active PsA and Opdivo was approved in the U.S. and EU for cHL.
“We continue to view business development as an important component of our strategy, focusing on opportunities where we can add strategic value and deliver returns. In May 2026, we entered into global strategic collaboration and license agreements with Hengrui to develop and commercialize 13 early stage assets in oncology, hematology and immunology. For additional information relating to this arrangement, refer to "Item 1. Financial Statements — Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements".”see in full comparison
Provision for income taxes in interim periods is determined based on the estimated annual effective tax rates and the tax impact of discrete items that are reflected immediately. Thesee in full comparisonincreasedecreases in the effective taxraterateswasfor the second quarter of 2026 and year-to-date were primarily driven by jurisdictional earnings mix, including the impact of amortization of acquired intangible assets, partially offset by the income tax impact ofcertainthediscreteBioNTechadjustments.collaboration in 2025. Excluding the impact of specified items, theincreaseincreases in the effective taxraterateswasfor the second quarter of 2026 and year-to-date were primarily driven by jurisdictional earningsmix.mix, including the income tax impact of the BioNTech collaboration in 2025.
“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, Baraclude and Orencia for 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. …”see in full comparison
Full comparison: every changed paragraph (61)
During the first quarter ofIn 2026, we made meaningful progress advancing our pipeline, highlighted by: (i) positive interim Phase III results from the SUCCESSOR‑2 study of oral mezigdomide in RRMM, (ii) positive Phase III results from the SCOUT-HCM trial of Camzyos in adolescents with symptomatic oHCM, (iii) positive top‑line results from a Phase II trial for Reblozyl in adults with Alpha (α)-Thalassemia, (iv) positive interim top‑line results from a Phase III trial conducted in China for iza-bren in previously treated unresectable locally advanced or metastatic TNBC, and (v) FDA acceptance of our NDA for iberdomide in combinationRRMM with standarda therapyPDUFA date of August 17, 2026; (ii) FDA acceptance of our NDA for mezigdomide in RRMM with a PDUFA date of May 13, 2027; (iii) positive interim Phase II results from the ROSETTA Lung-02 study of pumitamig in patients with RRMM.previously untreated advanced NSCLC; (iv) positive interim results from two Phase III studies conducted in China for iza-bren in heavily pretreated, unresectable locally advanced or metastatic TNBC and recurrent or metastatic ESCC; and (v) FDA acceptance of our sNDA for Camzyos in adolescents with symptomatic oHCM with a PDUFA date of September 30, 2026. Additionally, Sotyktu was approved in the U.S. and EU for the treatment of adults with active PsA and Opdivo was approved in the U.S. and EU for cHL.
We continue to view business development as an important component of our strategy, focusing on opportunities where we can add strategic value and deliver returns. In May 2026, we entered into global strategic collaboration and license agreements with Hengrui to develop and commercialize 13 early stage assets in oncology, hematology and immunology. For additional information relating to this arrangement, refer to "Item 1. Financial Statements — Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements".
Revenues increased 3%6% during the firstsecond quarter of 2026.2026 Demandand increased4% year-to-date, primarily reflecting higher demand and higher average net selling prices across the Growth Portfolio and for Eliquis, which was partially offset by the impact of generics across the remainder of the Legacy Portfolio. Additionally, revenues were impacted by lower average net selling prices for the Legacy Portfolio and foreign exchange impacts of 2%. Excluding foreign exchange impacts, revenues increased 1%.
The $0.11 increase in GAAP EPS of $0.98 and $1.08 for the firstsecond quarter of 2026 and year-to-date, respectively, was primarily due to a one-time Acquired IPRD charge in 2025 and the impact of certain specified items, including lower amortization of acquired intangible assets, and higher revenues in 2026, partially offset by higher IPRD impairment charges in 2026 and the expiry of royalty income on diabetes products at the end of 2025. After adjusting for specified items, the $0.22 decreaseincrease in non-GAAP EPS of $0.58 and $0.36 for the second quarter of 2026 and year-to-date, respectively, was primarily due to the aforementioned Acquired IPRD charge and higher revenues, partially offset by the expiry of royalty income on diabetes products at the end of 2025.products.
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, Baraclude and Orencia for 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.
In accordanceDecember with2025, we announced the U.S. Government Agreement,Agreement pursuant to which BMS will receive certain U.S. tariff relief until January 2029, including for recently imposed tariffs relating to patented pharmaceuticals and associated pharmaceutical ingredients pursuant to the Presidential Proclamation dated April 2, 2026, and will not be subject to future pricing mandates in the U.S. while the agreement remains in effect. 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.
The following is a summary of the significant approvals received in 2026 as of AprilJuly 30, 2026:
Refer to "—Product and Pipeline Developments" for a listing of other developments in our marketed products and late-stage pipeline since the start of the firstsecond quarter of 2026.
•U.S. revenues decreasedincreased 1%6% during the firstsecond quarter of 2026,2026 and 2% year-to-date, reflecting higher demand and higher average net selling prices across the Growth Portfolio and for Eliquis, partially offset by the impact of generic erosion within the remainder of the Legacy Portfolio. Additionally, revenues were impacted by lower average net selling prices for the Legacy Portfolio. Average U.S. net selling prices decreasedincreased 1%4% year-to-date compared to the corresponding period a year ago.
•International revenues increased 11%5% during the firstsecond quarter of 2026,2026 and 8% year-to-date, 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%4% during the firstsecond quarter of 2026.2026 and 3% year-to-date.
No single country outside the U.S. contributed more than 10% of total revenues during the threesix months ended MarchJune 31,30, 2026 and 2025. 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.
Reductions/(increases) to provisions for product sales made in prior periods resulting from changes in estimates were $(21)$88 million and $289$67 million for the three and six months ended MarchJune 31,30, 2026 and $42 million and $331 million for the three and six months ended June 30, 2025, respectively. The reduction to provision recognized for the threesix months ended MarchJune 31,30, 2025 primarily related to lower than expected Medicaid utilization. The changes in gross product sales and GTN adjustments were primarily due to a list price reduction for Eliquis in the U.S. in 2026.
•Opdivo revenues decreased 5%3% during the firstsecond quarter of 2026,2026 and 4% year-to-date, primarily due to lower demand in the U.S., reflecting greater utilization of Opdivo Qvantig, partially offset by foreign exchange impacts of 1% and 2%, respectively. Additionally, year-to-date reflects changes in sales channel inventory and timing of customer orders in the U.S., partially offset by foreign exchange impacts of 3%.U.S. Excluding foreign exchange impacts, revenues decreased 8%.4% and 6%, respectively.
•Opdivo Qvantig revenues increased more than 200% during the firstsecond quarter of 2026,2026 and year-to-date, primarily due to higher demand as a result of the product's launch in 2025.
•Orencia revenues increased 6%7% during the firstsecond quarter of 2026,2026 and year-to-date, primarily due to higher demand in the U.S. and higher average net selling prices. The year-to-date increase also reflects foreign exchange impacts of 2%.1%. Excluding foreign exchange impacts, revenues increased 5%.7% and 6%, respectively. Formulation and additional patents expire in 2026 and beyond. In April 2026, BMS entered into agreements with Dr. Reddy's Laboratories that allow for (i) an Orencia biosimilar for intravenous administration to be marketed in the U.S. upon approval and (ii) an Orencia biosimilar for subcutaneous administration to be marketed in the U.S. as early as February 2028. BMS is not aware of an Orencia biosimilar currently on the market in the U.S., EU or Japan.
•Yervoy revenues increased 4%6% during the firstsecond quarter of 2026,2026 and 5% year-to-date, primarily due to higher demand across international markets and foreign exchange impacts of 3%.1% and 2%, respectively. Excluding foreign exchange impacts, revenues increased 2%.5% and 3%, respectively. BMS is not aware of a Yervoy biosimilar on the market in the U.S., EU or Japan.
•Reblozyl revenues increased 16%29% during the firstsecond quarter of 2026,2026 and 23% year-to-date, primarily due to higher demanddemand. andThe year-to-date increase also reflects foreign exchange impacts of 1%. Excluding foreign exchange impacts, revenues increased 15%.29% and 23%, respectively.
•Breyanzi revenues increased 56% during the first quarter of 2026, primarily due to higher demand and foreign exchange impacts of 3%. Excluding foreign exchange impacts, revenues increased 53%.
•Opdualag revenues increased 17% during the first quarter of 2026, primarily due to higher demand and foreign exchange impacts of 2%. Excluding foreign exchange impacts, revenues increased 15%.
•Camzyos revenues increased 97% during the first quarter of 2026, primarily due to higher demand and foreign exchange impacts of 4%. Excluding foreign exchange impacts, revenues increased 94%.
•Zeposia revenues increased 11% during the first quarter of 2026, primarily due to higher demand in the U.S. and foreign exchange impacts of 4%. Excluding foreign exchange impacts, revenues increased 7%.
•Sotyktu revenues increased 24% during the first quarter of 2026, primarily due to higher demand across international markets and foreign exchange impacts of 4%. Excluding foreign exchange impacts, revenues increased 20%.
•KrazatiBreyanzi revenues increased 4%41% during the firstsecond quarter of 2026,2026 and 48% year-to-date, primarily due to higher demanddemand. inThe theyear-to-date U.S.increase andalso reflects foreign exchange impacts of 1%. Excluding foreign exchange impacts, revenues increased 3%.41% and 46%, respectively.
•CobenfyOpdualag revenues increased 107%23% during the firstsecond quarter of 2026,2026 and 20% year-to-date, primarily due to higher demand and foreign exchange impacts of 1% in theboth U.S.periods. Excluding foreign exchange impacts, revenues increased 22% and 19%, respectively.
•Camzyos revenues increased 60% during the second quarter of 2026 and 74% year-to-date, primarily due to higher demand and foreign exchange impacts of 1% and 2%, respectively. Excluding foreign exchange impacts, revenues increased 59% and 72%, respectively.
•Zeposia revenues increased 12% during the second quarter of 2026 and year-to-date, primarily due to higher average net selling prices, higher demand, and foreign exchange impacts of 1% and 2%, respectively. Excluding foreign exchange impacts, revenues increased 12% and 10%, respectively.
•Sotyktu revenues increased 23% during the second quarter of 2026 and 24% year-to-date, primarily due to higher average net selling prices, higher demand, and foreign exchange impacts of 1% and 2%, respectively. Excluding foreign exchange impacts, revenues increased 23% and 21%, respectively.
•Krazati revenues increased 14% during the second quarter of 2026 and 9% year-to-date, primarily due to higher demand and higher average net selling prices. The year-to-date increase also reflects foreign exchange impacts of 1%. Excluding foreign exchange impacts, revenues increased 14% and 8%, respectively.
•Cobenfy revenues increased 81% during the second quarter of 2026 and 92% year-to-date, primarily due to higher demand in the U.S.
•Eliquis revenues increased 16%22% during the firstsecond quarter of 2026,2026 and 19% year-to-date, primarily due to higher demand in the U.S. anddemand, foreign exchange impacts of 3%.1% and 2%, respectively, and higher average net selling prices in the U.S. In 2026, the Company reduced the list price for Eliquis in the U.S., which resulted in higher realized average net selling prices due to lower rebates. Excluding foreign exchange impacts, revenues increased 13%.21% and 17%, respectively. Following the May 2021 expiration of regulatory exclusivity for Eliquis in Europe, generic manufacturers have sought to challenge our Eliquis patents and related SPCs and have begun marketing generic versions of Eliquis in 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 Eliquis patents and related SPCs being filed in various countries in Europe. In the EU, the apixaban composition of matter patents and related SPCs expire in November 2026. Additionally, in November 2025, BMS and Pfizer initiated a patent infringement action against an applicant seeking approval to market apixaban products in the U.S. We believe in the innovative science behind Eliquis and the strength of our intellectual property, which we will defend against infringement. Refer to "Item 1. Financial Statements—Note 18. Legal Proceedings and Contingencies—Intellectual Property" for further information.
•Revlimid revenues decreased 63%49% during the firstsecond quarter of 2026,2026 and 56% year-to-date, primarily due to lower demand in the U.S. as a result of generic erosion.erosion, partially offset by higher average net selling prices. 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 revenues decreased 22% during the first quarter of 2026, primarily due to lower demand as a result of generic erosion. In the U.S. (March 2026) and EU, generics have entered the market.
•SprycelPomalyst/Imnovid revenues decreased 58%71% during the firstsecond quarter of 2026,2026 and 48% year-to-date, primarily due to lower demand in the U.S. as a result of generic erosion. The second quarter decrease also reflects foreign exchange impacts of (1)%. Excluding foreign exchange impacts, revenues decreased 59%.71% and 47%, respectively. In the U.S.,U.S. EU(March 2026) and Japan,EU, generics have entered the market.
•AbraxaneSprycel revenues decreased 53%27% during the firstsecond quarter of 2026,2026 and 46% year-to-date, primarily due to lower demand as a result of generic erosion,erosion. partiallyThe offsetsecond byquarter decrease also reflects foreign exchange impacts of 1%.(1)%. Excluding foreign exchange impacts, revenues decreased 54%.26% and 45%, respectively. In the U.S., EU and Japan, generics have entered the market.
•Abraxane revenues decreased 47% during the second quarter of 2026 and 50% year-to-date, primarily due to lower demand as a result of generic erosion.
Pursuant to the SEC Consent Order described under "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations— SEC Consent Order" in our 2025 Form 10-K, 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 MarchJune 31,30, 2026, for our U.S. distribution channels, and as of DecemberMarch 31, 2025,2026, 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 accounted for approximately 90% of total gross sales of U.S. products during the threesix months ended MarchJune 31,30, 2026. 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.
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 during the threesix months ended MarchJune 31,30, 2026 is not available prior to the filing of this Quarterly Report on Form 10-Q. 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.
NM Calculation is not meaningful.
Cost of products sold increased by $388$354 million in the firstsecond quarter of 2026,2026 and $742 million year-to-date, primarily due to higher alliance profit sharing and product mix.sharing.
Selling, general and administrative expense increased by $32$113 million in the firstsecond quarter of 2026,2026 and $145 million year-to-date, primarily due to higher investments in new product launches, partially offset by cost savings from the Company's ongoing strategic productivity initiative.initiative in 2026.
Research and development expense increased by $393$379 million in the firstsecond quarter of 2026,2026 and $771 million year-to-date, primarily due to higher IPRD impairment charges and the purchase of $410a million,priority review voucher, partially offset by cost savings from the Company's ongoing strategic productivity initiative.initiative in 2026.
Amortization of acquired intangible assets decreased by $393 million in the firstsecond quarter of 2026,2026 and $786 million year-to-date, primarily due to the lower amortization expense related to Pomalyst. The Pomalyst acquired marketed product right was fully amortized in the fourth quarter of 2025.
Other (income)/expense, net changed by $306$555 million in the firstsecond quarter of 2026 and $861 million year-to-date as discussed below.
•Litigation and other settlements includes amounts related to pricing, sales and promotional practices disputes in the first quarter of 2025.
•Contingent consideration reflects the change in fair value of the contingent value rights associated with the Mirati acquisition during 2025. Refer to "Item 1. Financial Statements—Note 5. Other (Income)/Expense, Net" for more information.
•Gains on equity investments duringin the firstsecond quarter of 2026 areand year-to-date were primarily driven by equity in net income of affiliates and upward adjustments in equity investments without RDFV.RDFV, respectively. Refer to “Item 1. Financial Statements—Note 9. Financial Instruments and Fair Value Measurements” for more information.
•Divestiture (gains)/losses in 2026 include a $109 million gain related to the sale of BMS's 60% ownership stake in Sino-American Shanghai Squibb Pharmaceuticals. Refer to “Item 1. Financial Statements—Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements” for more information.
Provision for income taxes in interim periods is determined based on the estimated annual effective tax rates and the tax impact of discrete items that are reflected immediately. The increasedecreases in the effective tax raterates wasfor the second quarter of 2026 and year-to-date were primarily driven by jurisdictional earnings mix, including the impact of amortization of acquired intangible assets, partially offset by the income tax impact of certainthe discreteBioNTech adjustments.collaboration in 2025. Excluding the impact of specified items, the increaseincreases in the effective tax raterates wasfor the second quarter of 2026 and year-to-date were primarily driven by jurisdictional earnings mix.mix, including the income tax impact of the BioNTech collaboration in 2025.
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) integration expenses, (iv) restructuring costs, (v) accelerated depreciation and impairment of property, plant and equipment and intangible assets, (vi) costs of acquiring a priority review voucher, (vii) divestiture gains or losses, (viiviii) stock compensation resulting from acquisition-related equity awards, (ix) pension, legal and other contractual settlement charges, (viiix) equity investment and contingent value rights fair value adjustments (including fair value adjustments attributed to limited partnerships and other investments), and (ixxi) 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. We also provide worldwide and 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 AprilJuly 30, 2026 and are incorporated herein by reference.
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, debt maturities, as well as any debt repurchases through redemptions or tender offers. During the threesix months ended MarchJune 31,30, 2026, our net debt position decreased by $436$2.4 millionbillion primarily driven by cash provided by operations of $1.1$4.5 billion and proceeds from the sale of equity investment securities,billion, partially offset by dividend payments of $1.3$2.6 billion.
During the threesix months ended MarchJune 31,30, 2026, $1.7 billion of debt matured and was repaid, including the $1.2 billion 3.20% Notes and $500 million of floating rate notes matured and were repaid.notes.
During the six months ended June 30, 2025, the €575 million 1.000% Euro Notes matured and were repaid.
As of MarchJune 31,30, 2026 and December 31, 2025, we had a five-year $5.0 billion revolving credit facility, which is extendable annually by one year with the consent of the lenders. In January 2026, we extended the termination date of the credit facility from January 2030 to January 2031. The facility provides for customary terms and conditions with no financial covenants and is used to provide backup liquidity for the Company's commercial paper borrowings. No borrowings were outstanding under the revolving credit facility as of MarchJune 31,30, 2026 and December 31, 2025.
Dividend payments were $1.3$2.6 billion during the threesix months ended MarchJune 31,30, 2026. The decision to authorize dividends is made on a quarterly basis by our Board of Directors.
During the three months ended March 31, 2026 and 2025, income tax payments were $239 million and $235 million.
The $850$1.4 millionbillion decrease in cash provided by operating activities compared to 2025 was driven by lower net customer receipts, primarily due to a list price reduction for Eliquis, and higher litigation-related disbursements, partially offset by lower expenses due to the ongoing strategic productivity initiative.
Cash used in investing activities during 2026 was primarily driven by net purchases of marketable debt securities of $422$1.9 million, partially offset by proceeds from the sale of equity investment securities of $391 million.billion.
Cash used in financing activities during 2026 was primarily driven by dividend payments of $1.3$2.6 billion and the repayment of $500$1.7 millionbillion of floatinglong-term rate notes.debt.
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 R&D programs in Phase III development include both investigational compounds for initial indications and additional indications or formulations for marketed products. The following are the developments in our marketed products and our late-stage pipeline since the start of the firstsecond quarter of 2026 as of AprilJuly 30, 2026:
BMY insider buying and selling (Form 4)
Form 4 filings since 2026-04-11: 0 open-market purchases and 2 open-market sales (about $437.2K), across 9 filings with stock transactions. Awards, option exercises, tax withholding and gifts are listed but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-10-02 | Gallman Cari |
Option exercise | 4,559 | — | — |
| 2026-10-02 | Gallman Cari |
Shares withheld for tax | 2,332 | $61.15 | $142.6K |
| 2026-09-09 | Massacesi Cristian |
Open-market sale | 6,249 | $64.57 | $403.5K |
| 2026-09-01 | Short Bartie Wendy |
Option exercise | 1,236 | $66.92 | $82.7K |
| 2026-09-01 | Short Bartie Wendy |
Shares withheld for tax | 633 | $66.92 | $42.4K |
| 2026-08-25 | Holzer Phil M |
Open-market sale | 500 | $67.50 | $33.8K |
| 2026-08-01 | Massacesi Cristian |
Option exercise | 51,172 | — | — |
| 2026-08-01 | Massacesi Cristian |
Shares withheld for tax | 26,175 | $65.31 | $1.7M |
| 2026-08-01 | Gallman Cari |
Option exercise | 1,061 | — | — |
| 2026-08-01 | Gallman Cari |
Shares withheld for tax | 543 | $65.31 | $35.5K |
| 2026-06-15 | Haller Julia A |
Option exercise | 20,460 | $53.76 | $1.1M |
| 2026-06-03 | Short Bartie Wendy |
Shares withheld for tax | 3,876 | $54.72 | $212.1K |
| 2026-06-03 | Short Bartie Wendy |
Option exercise | 8,040 | — | — |
| 2026-05-01 | Lenkowsky Adam |
Other | 203 | — | — |
| 2026-05-01 | Lenkowsky Adam |
Option exercise | 1,373 | — | — |
| 2026-05-01 | Lenkowsky Adam |
Shares withheld for tax | 599 | $58.22 | $34.9K |
Well-known investors holding BMY (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| AQR Capital Management (Cliff Asness) | 2026-06-30 | 27,357,486 | $1.6B | 0.55% | Reduced 8% |
| PRIMECAP Management | 2026-06-30 | 24,923,900 | $1.4B | 0.85% | No change |
| Two Sigma Investments | 2026-06-30 | 10,085,383 | $581.1M | 0.44% | Reduced 13% |
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 1,572,329 | $90.6M | 0.05% | Added 5% |
| Renaissance Technologies | 2026-06-30 | 977,051 | $59.3M | — | Sold out |
| Gotham Asset Management (Joel Greenblatt) | 2026-06-30 | 892,969 | $51.5M | 0.12% | Added 4% |
| Millennium Management (Israel Englander) | 2026-06-30 | 752,576 | $43.4M | 0.03% | Reduced 89% |
| D. E. Shaw & Co. | 2026-06-30 | 559,407 | $32.2M | 0.02% | Added 81% |
| Point72 Asset Management (Steve Cohen) | 2026-06-30 | 531,198 | $32.2M | — | Sold out |
| Bridgewater Associates | 2026-06-30 | 241,689 | $14.7M | — | Sold out |
| Dodge & Cox | 2026-06-30 | 42,361 | $2.4M | 0.0% | Reduced 99% |
| Tweedy, Browne | 2026-06-30 | 37,570 | $2.2M | 0.16% | Added 44% |