BMY

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How BMY rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025

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Risk Factors—Product, Industry and Operational Risks—Increased pricing pressure and other restrictions in the U.S. and abroad continue to negatively affect our revenues and profit margins”, “—We could lose market exclusivity of a product earlier than expected”, “—We could experience difficulties, delays and disruptions in our supply chain as well as in the manufacturing, distribution and sale of our products” and “—Changes to tax regulations could negatively impact our earnings”.
Significant Product and Pipeline Approvals The following is a summary of the significant approvals received: Product Date Approval Breyanzi December 2025 FDA approval of Breyanzi for the treatment of adult patients with relapsed or refractory MZL who have received at least two prior lines of systemic therapy.
Breyanzi November 2025 EC approval of Breyanzi for the treatment of adult patients with relapsed or refractory MCL after at least two lines of systemic therapy including a Bruton's tyrosine kinase inhibitor.
Augtyro November 2025 Japan’s Ministry of Health Labour and Welfare approval of Augtyro for the treatment of NTRK fusion-positive, advanced or recurrent solid tumors.
Opdivo + Yervoy August 2025 Japan’s Ministry of Health Labour and Welfare approval of Opdivo + Yervoy for the treatment of unresectable advanced or recurrent microsatellite instability-high colorectal cancer.
Opdivo + Yervoy June 2025 Japan’s Ministry of Health Labour and Welfare approval of Opdivo + Yervoy for the treatment of unresectable HCC.
Inrebic June 2025 Japan’s Ministry of Health Labour and Welfare approval of Inrebic for the treatment of myelofibrosis.
Opdivo Qvantig May 2025 EC approval of Opdivo Qvantig for use across multiple adult solid tumors as monotherapy, monotherapy maintenance following completion of intravenous Opdivo plus Yervoy combination therapy, or in combination with chemotherapy or cabozantinib.
Opdivo May 2025 EC approval for perioperative regimen of neoadjuvant Opdivo and chemotherapy followed by surgery and adjuvant Opdivo for the treatment of resectable NSCLC at high-risk of recurrence in adult patients whose tumors have PD-L1 expression ≥1%.
Opdivo + Yervoy April 2025 FDA approval of Opdivo + Yervoy as a first-line treatment of adult patients with unresectable or metastatic HCC.
Opdivo + Yervoy April 2025 FDA approval of Opdivo + Yervoy as a first-line treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient CRC.
Camzyos March 2025 Japan’s Ministry of Health Labour and Welfare approval of Camzyos for the treatment of oHCM.
Breyanzi March 2025 EC approval of Breyanzi for the treatment of adult patients with relapsed or refractory FL after two or more lines of systemic therapy.
Opdivo + Yervoy March 2025 EC approval of Opdivo + Yervoy for the first-line treatment of adult patients with unresectable or advanced HCC.
Augtyro February 2025 EC approval for Augtyro as a treatment for adult patients with ROS1-positive NSCLC and for adult and pediatric patients 12 years of age and older with NTRK-positive solid tumors.
Refer to “—Product and Pipeline Developments” for all of the developments in our marketed products and late-stage pipeline in 2025 and in early 2026.
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.
During 2025, we entered into a global strategic collaboration with BioNTech for the co-development and co-commercialization of pumitamig (BNT327/BMS986545), a potentially transformative PD-L1/VEGF-A bispecific that could set a new standard of care across multiple tumor types.
Additionally, we believe we have significant opportunity in radiopharmaceuticals as a new oncology modality with opportunities to advance RYZ101, RYZ401 and RYZ801.
In hematology, we see significant potential with our targeted protein degradation platform, which includes potentially first-in-class CELMoDs currently under investigation for multiple myeloma with iberdomide and mezigdomide and lymphoma with golcadomide as well as a potentially first-in-class BCL6 LDD with BMS-986458.
In cell therapy, we are building on our expertise and leadership, developing next generation CAR-T treatments with first-in-class potential, 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), an asset aimed at resetting the immune system, in autoimmune diseases.
We are exploring zola-cel's potential in multiple disease areas, including SLE, SSc and other indications.
In cardiovascular diseases, the LIBREXIA clinical program, in partnership with Johnson & Johnson, includes registrational trials in atrial fibrillation and secondary stroke prevention for milvexian.
Lastly, we have a growing, diverse neuroscience pipeline that includes several ongoing Phase III studies as well as several investigational programs aimed at advancing novel therapeutic approaches across neurological diseases.
We have established a strong foundation in IO with Opdivo , Yervoy and Opdualag, and have expanded our leadership in the area with the addition of Opdivo Qvantig .
In hematology, Reblozyl, continues to drive market share in the first line RS-positive and RS-negative settings in the U.S., and in cardiovascular diseases, Camzyos continues to provide benefits to patients with oHCM.
Additionally, in cell therapy, we continue to expand the range of B-cell malignancies treated by Breyanzi .
Finally, in immunology and neuroscience, respectively, registrational studies are ongoing for Sotyktu in systemic lupus erythematosus and Sjögren's disease and are ongoing or planned for Cobenfy in 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 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.
Accordingly, we seek to mobilize our capabilities and resources to positively impact the communities where we live, work, and serve around the world.
Acquisitions, Divestitures, Licensing and Other Arrangements For detailed information on significant acquisitions, divestitures, collaborations, licensing and other arrangements during 2025 refer to “Item 8.
Acquisitions, Divestitures, Licensing and Other Arrangements.” RESULTS OF OPERATIONS Regional Revenues The composition of the changes in revenues was as follows: Year Ended December 31, Dollars in millions 2025 2024 % Change Foreign Exchange (b) United States $ 33,279 $ 34,105 (2) % — International 13,828 13,199 5 % 2 % Other revenues (a) 1,087 996 9 % — Total Revenues $ 48,194 $ 48,300 — % 1 % (a) Other revenues include royalties and alliance-related revenues for products not sold by our regional commercial organizations, including royalties received from Merck on Winrevair *.
(b) Foreign exchange impacts were derived by applying the prior period average currency rates to the current period revenues.

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Gone since FY2024

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” and “—Changes to tax regulations could negatively impact our earnings.” Significant Product Approvals The following is a summary of the significant approvals received: Product Date Approval Augtyro January 2025 EC approval for Augtyro as a treatment for adult patients with ROS1-positive NSCL and for adult and pediatric patients 12 years of age and older with NTRK-positive solid tumors.
Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) December 2024 FDA approval for Opdivo Qvantig injection for subcutaneous use, a combination product of nivolumab co-formulated with recombinant human hyaluronidase, in 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 December 2024 Japan’s Ministry of Health, Labour and Welfare approval of Opdivo for the treatment of radically unresectable urothelial carcinoma.
Zeposia December 2024 Japan’s Ministry of Health, Labour and Welfare approval of Zeposia for the treatment of moderate to severe UC in patients who have had an inadequate response to conventional therapies.
Opdivo+Yervoy December 2024 EC approval of Opdivo plus Yervoy for the first-line treatment of adult patients with microsatellite instability-high or mismatch repair deficient unresectable or metastatic colorectal cancer.
Opdivo October 2024 FDA approval of Opdivo for the treatment of adult patients with resectable (tumors ≥ 4 cm or node positive) NSCLC and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent Opdivo as adjuvant treatment after surgery.
Cobenfy September 2024 FDA approval of Cobenfy for the treatment of schizophrenia in adults.
Augtyro September 2024 Japan's Ministry of Health, Labour and Welfare approval of Augtyro for the treatment of patients with ROS1 fusion-positive, unresectable advanced or recurrent NSCLC.
Breyanzi August 2024 Japan's Ministry of Health, Labour and Welfare approval of Breyanzi for the treatment of relapsed or refractory FL after one prior line of systemic therapy in patients with high-risk FL and after two or more lines of systemic therapy.
Krazati June 2024 FDA accelerated approval for Krazati in combination with cetuximab as a targeted treatment option for adult patients with KRAS G12C -mutated locally advanced or metastatic colorectal cancer, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
Augtyro June 2024 FDA accelerated approval of Augtyro for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.
Opdivo May 2024 EC approval of Opdivo in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
Breyanzi May 2024 FDA approval of Breyanzi for the treatment of adult patients with relapsed or refractory MCL who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor.
Product Date Approval Breyanzi May 2024 FDA accelerated approval of Breyanzi for the treatment of adult patients with relapsed or refractory FL who have received at least two prior lines of systemic therapy.
Abecma April 2024 FDA approval of Abecma for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
Reblozyl April 2024 EC expanded approval of Reblozyl to include the first-line treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk MDS.
Abecma March 2024 EC approval of Abecma for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
Breyanzi March 2024 FDA accelerated approval of Breyanzi for the treatment of adult patients with relapsed or refractory CLL or SLL who have received at least two prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor.
Opdivo March 2024 FDA approval of Opdivo , in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
Reblozyl January 2024 Japan's Ministry of Health, Labour and Welfare approval of Reblozyl for the treatment of anemia associated with myelodysplastic syndrome.
Refer to “—Product and Pipeline Developments” for all of the developments in our marketed products and late-stage pipeline in 2024 and in early 2025.
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 returns.
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.
The acquisition of RayzeBio, a leader in the field of radiopharmaceuticals for solid tumor oncology, provided us with RYZ101, a late-stage asset, an investigational new drug engine and in-house manufacturing capabilities.
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.
In cell therapy, we are building on our expertise and leadership, developing next generation CAR-T treatments with first-in-class potential.
We are investigating arlo-cel in pivotal studies targeting multiple myeloma and advancing development for CD19-targeted NEX-T, an optimized asset aimed at resetting the immune system, in autoimmune diseases.
We are exploring CD19-targeted NEX-T's potential in multiple disease areas, including systemic lupus erythematosus, MS, and other indications.
In cardiovascular diseases, the LIBREXIA clinical program, in partnership with Johnson & Johnson, includes three Phase III registrational trials for milvexian in atrial fibrillation, secondary stroke prevention and acute coronary syndrome.
Lastly in neuroscience, with the addition of Cobenfy , we have a growing, diverse neuroscience pipeline that includes a range of investigational therapies that are being studied for their disease-modifying potential as well as critical symptomatic relief.
Together with our proven track record, rapidly advancing pipeline and increasing use of 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.
We have established a foundation in IO with Opdivo , Yervoy and Opdualag and received FDA approval for Opdivo Qvantig in December 2024 for multiple indications at launch.
Reblozyl, in first-line MDS-associated anemia, continues to drive market share within the larger first-line 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, FL and MCL, making Breyanzi the CAR-T cell therapy available to treat the broadest array of B-cell malignancies.
In cardiovascular diseases, Camzyos continues to provide benefits to patients with oHCM, with the potential expansion opportunity into nHCM.
Finally, in neuroscience, we launched Cobenfy for the treatment of schizophrenia in adults.
Registrational studies 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.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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