BRISTOL MYERS SQUIBB CO

Previous wording

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 priorities are (i) to continue to renew and diversify our portfolio through launching new medicines, (ii) advancing our early, mid and late-stage pipeline, and (iii) executing disciplined business development. Our focus is on discovering, developing and delivering transformational medicines for patients facing serious diseases in the following five core therapeutic areas: (i) oncology with a priority in certain tumor types, including diversification beyond IO; (ii) hematology with opportunities to expand leadership position in multiple myeloma, as well as broaden our portfolio across leukemias, lymphomas and non-malignant hematologic diseases; (iii) immunology with a focus in dermatology, rheumatology and gastrointestinal disorders, establishing new standards of care in pulmonology and rapidly advancing cell therapy into immunology diseases; (iv) cardiovascular diseases with focus on cardiomyopathies, heart failures and thrombotic diseases; and (v) neuroscience with a focus on neuropsychiatry, neurodegenerative and neuroinflammation diseases. We are working on accelerating our drug development and delivery of our innovative medicines to patients, enhancing our commercial operating model, as well as enhancing flexibility and reliability of our manufacturing network. We remain committed to strategic business development and maintaining a strong investment grade credit rating, growing the dividend and reducing additional debt that was issued in support of recent transactions during the first quarter of 2024. For further information on our strategy, see "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations—Executive Summary—Strategy" in our 2023 Form 10-K. Refer to the Summary of Abbreviated Terms at the end of this Quarterly Report on Form 10-Q for terms used throughout the document.

Current wording

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 priorities are to (i) focus on transformational medicines where we have a competitive advantage (ii) drive operational excellence and (iii) strategically allocate capital for long-term growth and returns. Our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases in the following core therapeutic areas: oncology and hematology with novel modalities in cell therapies, protein degraders, ADCs and radiopharmaceuticals; immunology with a focus on establishing new standards of care in pulmonology, rapidly advancing cell therapy into immunology diseases and transformational programs to control inflammation, reset immune memory and promote homeostasis in dermatology, rheumatology and gastrointestinal disorders; cardiovascular diseases by leveraging deep expertise across thrombotic diseases, heart failures and cardiomyopathies; and neuroscience with a focus on developing new treatments in neuropsychiatry and neurodegeneration. We are working on accelerating our drug development and delivery of our innovative medicines to patients, enhancing our commercial operating model, as well as enhancing flexibility and reliability of our manufacturing network. We remain committed to strategic business development, maintaining a strong investment grade credit rating, the dividend and reducing debt. For further information on our strategy, see "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations—Executive Summary—Strategy" in our 2023 Form 10-K. Refer to the Summary of Abbreviated Terms at the end of this Quarterly Report on Form 10-Q for terms used throughout the document.

Previous wording

In 2024, we achieved significant advances in CAR-T cell therapy with the approval of Breyanzi in the U.S. for adults with relapsed or refractory CLL/SLL, follicular lymphoma and mantle cell lymphoma; and Abecma in the U.S. and EU for triple-class exposed relapsed and refractory multiple myeloma after two or more prior lines of therapy. In addition, Reblozyl received expanded approval to include the first-line treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk myelodysplastic syndromes in the EU and Japan. In oncology, we received (i) accelerated approval in the U.S. of Krazati in combination with cetuximab as a targeted treatment option for adult patients with KRAS G12C-mutated locally advanced or metastatic colorectal cancer; (ii) approval in the U.S. of Augtyro for the treatment of patients with NTRK-positive locally advanced or metastatic solid tumors; and (iii) both in the U.S. and EU, approval of Opdivo in combination with cisplatin and gemcitabine for first-line treatment of adult patients with unresectable or metastatic muscle invasive urothelial carcinoma. Refer to "—Product and Pipeline Developments" for additional updates on our pipeline.

Current wording

In September 2024, we received FDA approval for Cobenfy(xanomeline and trospium chloride), formerly known as KarXT, for the treatment of schizophrenia in adults, re-establishing our presence in neuroscience. Cobenfy represents the first new pharmacological approach to treat schizophrenia in decades, with a mechanism of action distinct from current therapies. Registrational studies are planned for Cobenfy in Adjunctive Schizophrenia, Alzheimer's Psychosis, Alzheimer's Agitation, Alzheimer's Cognition, Bipolar I Disorder and autism spectrum disorder irritability. In addition, year-to-date, we have achieved significant advances in CAR-T cell therapy with the approval of 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; and Abecma in the U.S. and EU for triple-class exposed relapsed and refractory multiple myeloma after two or more prior lines of therapy. Furthermore, Reblozyl received 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. In oncology, we continue making advancements with (i) 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; (ii) accelerated approval in the U.S. of Krazati in combination with cetuximab, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic colorectal cancer; (iii) approval in the U.S. of Augtyro for the treatment of patients with NTRK-positive locally advanced or metastatic solid tumors; (iv) approval in Japan of Augtyro for the treatment of patients with ROS1 fusion-positive, unresectable advanced or recurrent NSCLC; and (v) both in the U.S. and EU, approval of Opdivo in combination with cisplatin and gemcitabine for first-line treatment of adult patients with unresectable or metastatic muscle invasive urothelial carcinoma. Refer to "—Product and Pipeline Developments" for additional updates on our pipeline.

Previous wording

Additionally, we completed the following acquisitions in 2024: (i) Karuna, a biopharmaceutical company in the area of developing and delivering psychiatric and neurological conditions medicines; (ii) RayzeBio, a clinical-stage radiopharmaceutical therapeutics company with a pipeline of potentially first-in-class and best-in-class drug development programs, and (iii) Mirati, a commercial stage targeted oncology company, with a commercialized medicine, Krazati, in addition to a pipeline of clinical and pre-clinical stage oncology assets. BMS also entered into a strategic collaboration with SystImmune, to co-develop and co-commercialize BL-B01D1, a bispecific topoisomerase inhibitor-based anti-body drug conjugate, which is currently being evaluated in a Phase I clinical trial for metastatic or unresectable NSCLC and is also in development for breast cancer and other tumor types. We also entered into a worldwide capacity reservation and supply agreement with Cellares for the manufacturing of CAR-T cell therapies. This agreement is expected to enable us to expand our manufacturing capacity through a platform that is scalable and has the potential to improve turnaround time. For additional information relating to our acquisitions, divestitures, licensing and other arrangements refer to "Item 1. Financial Statements—Note 3. Alliances" and "Item 1. Financial Statements—Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements".

Current wording

Additionally, we completed the following acquisitions in 2024: (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 best-in-class drug development programs; and (iii) Mirati, a commercial stage targeted oncology company, with a commercialized medicine, Krazati, in addition to a pipeline of clinical and pre-clinical stage oncology assets. BMS also entered into a strategic collaboration with SystImmune, to co-develop and co-commercialize BL-B01D1, a bispecific topoisomerase inhibitor-based anti-body drug conjugate, which is currently being evaluated in a Phase I clinical trial for metastatic or unresectable NSCLC and is also in development for breast cancer and other tumor types. We also entered into a worldwide capacity reservation and supply agreement with Cellares for the manufacturing of CAR-T cell therapies. This agreement is expected to enable us to expand our manufacturing capacity through a platform that is scalable and has the potential to improve turnaround time. For additional information relating to our acquisitions, divestitures, licensing and other arrangements refer to "Item 1. Financial Statements—Note 3. Alliances" and "Item 1. Financial Statements—Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements".

Previous wording

We remain committed to the strategic allocation of resources and investing in areas that maximize value and drive sustainable growth. In the first half of 2024, we began to execute a strategic productivity initiative that will drive approximately $1.5 billion in annual cost savings by the end of 2025, the majority of which are expected to be reinvested to fund innovation and drive growth. As a result, we are focusing resources on R&D programs with the potential to deliver the greatest return on investment, prioritizing investments in key growth brands, and optimizing operations across the organization. The exit costs resulting from these actions are included in our updated 2023 Restructuring Plan.

Current wording

We remain committed to the strategic allocation of resources and investing in areas that maximize value and drive sustainable growth. We continue to execute a strategic productivity initiative that will drive approximately $1.5 billion in annual cost savings by the end of 2025, the majority of which are expected to be reinvested to fund innovation and drive growth. As a result, we are focusing resources on R&D programs with the potential to deliver the greatest return on investment, prioritizing investments in key growth brands, and optimizing operations across the organization. The exit costs resulting from these actions are included in our updated 2023 Restructuring Plan.

Previous wording

Revenues increased by 9% during the second quarter of 2024 and 7% year-to-date due to the Growth Portfolio and Eliquis, partially offset by Revlimid.

Current wording

Revenues increased by 8% during the third quarter of 2024 and 7% year-to-date due to the Growth Portfolio and Eliquis, partially offset by Spryceldue to generic erosion. Year-to-date was also partially offset by Revlimid.

Previous wording

The $7.11 decrease in GAAP EPS year-to-date was primarily driven by higher one-time Acquired IPRD charges primarily from the Karuna asset acquisition and SystImmune collaboration ($6.29) and the impact of certain specified items, including intangible asset impairments, as well as the cash settlement of unvested stock awards. After adjusting for specified items, the $6.13 decrease in non-GAAP EPS was primarily due to the above mentioned Acquired IPRD charges, higher interest expense resulting from the recent acquisitions and lower royalty income, partially offset by higher revenues.

Current wording

The $7.44 decrease in GAAP EPS year-to-date was primarily driven by higher one-time Acquired IPRD charges primarily from the Karuna asset acquisition and SystImmune collaboration ($6.28) and the impact of certain specified items, including intangible asset impairments, as well as the cash settlement of unvested stock awards, partially offset by higher revenues. After adjusting for specified items, the $6.33 decrease in non-GAAP EPS year-to-date was primarily due to the aforementioned Acquired IPRD charges, partially offset by higher revenues.

Previous wording

Our products continue to be subject to increasing pressures across the portfolio from pharmaceutical market access and pricing controls and discounting, changes to tax and importation laws and other restrictions 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, which can 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 FDA approval, (ii) manufacturers to pay a rebate for Medicare Part B and Part D drugs when prices increase faster than inflation and (iii) Medicare Part D redesign replacing the current Part D CGDP and establishes a $2,000 cap for out-of-pocket costs for Medicare beneficiaries beginning in 2025, with manufacturers being responsible for 10% of costs up to the $2,000 cap and 20% after that cap is reached. In August 2023, Eliquis was selected as one of the first 10 medicines subject to "negotiation" for government-set prices beginning in 2026, and it is possible that more of our products could be selected in future years, which could, among other things, accelerate revenue erosion prior to expiry of intellectual property protections.

Current wording

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 can 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 FDA approval, (ii) manufacturers to pay a rebate for Medicare Part B and Part D drugs when prices increase faster than inflation and (iii) Medicare Part D redesign replacing the current Part D CGDP and establishes a $2,000 cap for out-of-pocket costs for Medicare beneficiaries beginning in 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 U.S. Department of Health and Human Services 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. It is possible that more of our products could be selected in future years, 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.

Previous wording

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 a final rule will be adopted along the lines proposed and, if adopted, whether the government would seek to exercise march-in rights for any of our products. Other proposals and potential executive orders focused on drug pricing remain possible. The effect of reducing prices and reimbursement for certain of our products would significantly impact our business and consolidated results of operations.

Current wording

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 Biden Administration will finalize the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights 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.

Previous wording

At the state level, multiple states have passed, are pursuing or are considering government actions, legislation or proposals to change drug pricing and reimbursement (e.g., establishing prescription drug affordability boards, implementing manufacturer mandates tied to the Federal Public Health Service drug pricing program, etc.). Some of these state-level government actions, legislation and proposals may also influence federal and other state policies and legislation. Given the current uncertainty surrounding the adoption, timing and implementation of many of these measures, as well as pending litigation challenging such laws, we are unable to predict their full impact on our business. However, such measures could modify or decrease access, coverage, or reimbursement of our products, or result in significant changes to our sales or pricing practices, which could have a material impact on our revenues and results of operations. With respect to the Federal Public Health Service drug pricing program, eight states have enacted laws regulating manufacturer pricing obligations under the program. Several additional states are considering similar potential legislation or other government actions, and we expect other states may do the same in the future.

Current wording

At the state level, multiple states have passed, are pursuing or are considering government action via legislation or regulations to change drug pricing and reimbursement (e.g., establishing prescription drug affordability boards, implementing manufacturer mandates tied to the Federal Public Health Service Act drug pricing program, etc.). Some of these state-level actions may also influence federal and other state policies and legislation. Given the current uncertainty surrounding the adoption, timing and implementation of many of these measures, as well as pending litigation challenging such laws, we are unable to predict their full impact on our business. However, such measures could modify or decrease access, coverage, or reimbursement of our products, or result in significant changes to our sales or pricing practices, which could have a material impact on our revenues and results of operations. With respect to the Federal Public Health Service Act drug pricing program, eight states have enacted laws regulating manufacturer pricing obligations under the program to date. Several additional states are considering similar potential legislation or other government actions, and we expect other states may do the same in the future.

Previous wording

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, to be applied to repurchases beginning in 2023. 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. 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" and "—Changes to tax regulations could negatively impact our earnings" in our 2023 Form 10-K.

Current wording

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, to be applied to repurchases beginning in 2023. 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" and "—Changes to tax regulations could negatively impact our earnings" in our 2023 Form 10-K.

Previous wording

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 second quarter of 2024.

Current wording

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 third quarter of 2024.

Previous wording

•U.S. revenues increased 13% during the second quarter of 2024 and 10% year-to-date primarily due to higher demand for the Growth and Legacy Portfolios, partially offset by Abecma and Revlimid. Average U.S. net selling prices decreased 1% year-to-date compared to the same period a year ago.

Current wording

•U.S. revenues increased 9% during the third quarter of 2024 and year-to-date primarily due to higher demand for the Growth Portfolio and higher demand for Eliquis, partially offset by Spryceldue to generic erosion. Average U.S. net selling prices decreased 1% year-to-date compared to the same period a year ago.

Previous wording

•International revenues decreased 1% for both the second quarter of 2024 and year-to-date due to foreign exchange impacts and lower demand for the Legacy Portfolio, partially offset by higher demand for the Growth Portfolio. The negative foreign exchange impact of 7% during the second quarter and 5% year-to-date was primarily attributed to the devaluation of the Argentine peso, which was mostly offset by inflation-related local currency price increases.

Current wording

•International revenues increased 5% and 1% during the third quarter of 2024 and year-to-date, respectively, driven by higher demand for the Growth Portfolio, partially offset by lower demand for the Legacy Portfolio and foreign exchange impacts. The negative foreign exchange impacts of 4% and 5% during the third quarter and year-to-date, respectively, were primarily attributed to devaluation of the Argentine peso, which was mostly offset by inflation-related local currency price increases.

Previous wording

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. No single country outside the U.S. contributed more than 10% of total revenues during the six months ended June 30, 2024 and 2023. Our business is typically not seasonal.

Current wording

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. No single country outside the U.S. contributed more than 10% of total revenues during the nine months ended September 30, 2024 and 2023. Our business is typically not seasonal.

Previous wording

Reductions/(increases) to provisions for product sales made in prior periods resulting from changes in estimates were ($19 million) and $61 million for the three and six months ended June 30, 2024 and $11 million and $98 million for the three and six months ended June 30, 2023, respectively. 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 product mix and higher government channel rebates.

Current wording

Reductions to provisions for product sales made in prior periods resulting from changes in estimates were $42 million and $103 million for the three and nine months ended September 30, 2024 and $18 million and $116 million for the three and nine months ended September 30, 2023, respectively. 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 product mix and higher government channel rebates.

Previous wording

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, CRC and various gastric and esophageal cancers. There are several ongoing potentially registrational studies for Opdivo across other tumor types and disease areas, in monotherapy and in combination with Yervoy and various anti-cancer agents.

Current wording

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, CRC and various gastric and esophageal cancers. There are several ongoing registrational studies for Opdivo across other tumor types and disease areas.

Previous wording

•International revenues increased 6% during the second quarter of 2024 and 3% year-to-date primarily due to higher demand as a result of additional indication launches and core indications, partially offset by foreign exchange impacts of 12% and 10%, respectively. Excluding foreign exchange impacts, revenues increased 18% and 13%, respectively.

Current wording

•International revenues increased 7% during the third quarter of 2024 and 4% year-to-date primarily due to higher demand as a result of additional indication launches and core indications, partially offset by foreign exchange impacts of 9% and 10%, respectively. Excluding foreign exchange impacts, revenues increased 16% and 14%, respectively.

Previous wording

•International revenues increased 4% during the second quarter of 2024 and 7% year-to-date due to higher demand, partially offset by foreign exchange impacts of 7% in both periods. Excluding foreign exchange impacts, revenues increased by 11% and 14%, respectively.

Current wording

•International revenues increased 10% during the third quarter of 2024 and 8% year-to-date due to higher demand, partially offset by foreign exchange impacts of 7% in both periods. Excluding foreign exchange impacts, revenues increased by 17% and 15%, respectively.

Previous wording

•U.S. revenues increased 96% during the second quarter of 2024 and 92% year-to-date driven by higher demand due to a first line label extension in August 2023.

Current wording

•U.S. revenues increased 79% during the third quarter of 2024 and 87% year-to-date driven by higher demand due to a first line label extension in August 2023.

Previous wording

•U.S. revenues increased 52% during the second quarter of 2024 and 48% year-to-date primarily due to higher demand.

Current wording

•U.S. revenues increased 33% during third quarter of 2024 and 48% year-to-date primarily due to higher demand.

Previous wording

•U.S. revenues decreased 53% during the second quarter of 2024 and 55% year-to-date due to increased competition in BCMA targeted therapies.

Current wording

•U.S. revenues increased 12% during the third quarter of 2024 due to higher demand related to third line label extension in April 2024 and decreased 39% year-to-date due to increased competition in BCMA targeted therapies, partially offset by higher demand related to third line label extension.

Previous wording

•U.S. revenues increased 47% during the second quarter of 2024 and 48% year-to-date primarily due to higher demand enabled by expanded manufacturing capacity.

Current wording

•U.S. revenues increased 125% during the third quarter of 2024 and 75% year-to-date primarily due to higher demand enabled by expanded manufacturing capacity and new indication launches.

Previous wording

Krazati (adagrasib) — a highly selective and potent oral small-molecule inhibitor of the KRAS G12C mutation, indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy and for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic CRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. Krazati was brought into the BMS portfolio as part of the Mirati acquisition completed in 2024.

Current wording

Krazati (adagrasib) — a highly selective and potent oral small-molecule inhibitor of the KRAS G12C mutation, indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy and, in combination with cetuximab, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic CRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. Krazati was brought into the BMS portfolio as part of the Mirati acquisition completed in 2024.

Previous wording

Other Growth Brands — includes Onureg, Inrebic, Nulojix, Empliciti and royalty revenues.

Current wording

Other Growth Brands — includes Onureg, Inrebic, Nulojix, Emplicitiand royalty revenues.

Previous wording

•U.S. revenues increased 15% during the second quarter of 2024 primarily due to higher average net selling prices, higher demand and timing of sales channel inventory and customer orders.

Current wording

•U.S. revenues increased 15% during third quarter of 2024 and 12% year-to-date primarily due to higher demand and higher average net selling prices.

Previous wording

•International revenues decreased 2% during the second quarter of 2024 and 1% year-to-date primarily due to foreign exchange impacts of 2% and 1%, respectively. Excluding foreign exchange impacts, revenues were flat.

Current wording

•International revenues increased 3% during the third quarter of 2024 and were flat year-to-date primarily due to foreign exchange impacts of 1% and (1)%, respectively. Excluding foreign exchange impacts, revenues increased 2% and 1%, respectively.

Previous wording

•U.S. revenues decreased 4% during the second quarter of 2024 and 5% year-to-date primarily due to generic erosion and lower average net selling prices, partially offset by the impact of patients receiving free drug product from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which BMS donates products, in 2023.

Current wording

•U.S. revenues were flat during the third quarter of 2024 and decreased 3% year-to-date primarily due to generic erosion and lower average net selling prices, partially offset by the prior year impact of patients receiving free drug product from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which BMS donates products.

Previous wording

•International revenues decreased 24% during second quarter of 2024 and 15% year-to-date primarily due to generic erosion across several European countries and foreign exchange impacts of 4% in both periods. Excluding foreign exchange impacts, revenues decreased by 20% and 11%, respectively.

Current wording

•International revenues decreased 9% during third quarter of 2024 and 13% year-to-date primarily due to generic erosion across several European countries and foreign exchange impacts of 3% and 4%, respectively. Excluding foreign exchange impacts, revenues decreased by 6% and 9%, respectively.

Previous wording

•U.S. revenues increased 27% during the second quarter of 2024 and 19% year-to-date due to higher demand and the impact of patients receiving free drug product from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which BMS donates products, in 2023.

Current wording

•U.S. revenues increased 15% during the third quarter of 2024 and 17% year-to-date due to higher demand and the prior year impact of patients receiving free drug product from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which BMS donates products.

Previous wording

•International revenues decreased 39% during the second quarter of 2024 and 36% year-to-date primarily due to lower demand, lower average net selling prices and foreign exchange impacts of 5% and 4%, respectively. Excluding foreign exchange impacts, revenues decreased by 34% and 32%, respectively.

Current wording

•International revenues decreased 45% during the third quarter of 2024 and 39% year-to-date primarily due to generic erosion, lower average net selling prices and foreign exchange impacts of 3% and 4%, respectively. Excluding foreign exchange impacts, revenues decreased by 42% and 35%, respectively.

Previous wording

•In the U.S., BMS entered into settlement agreements with certain third parties to sell generic dasatinib products beginning in September 2024, or earlier in certain circumstances. In the EU, generic dasatinib products have entered the market. In Japan, the composition of matter patent for the treatment of non-imatinib-resistant CML has expired.

Current wording

•In the U.S. (September 2024) and EU, generic dasatinib products have entered the market. In Japan, the composition of matter patent for the treatment of non-imatinib-resistant CML has expired.

Previous wording

•U.S. revenues decreased 18% during the second quarter of 2024 and 14% year-to-date primarily due to lower demand.

Current wording

•U.S. revenues decreased 15% during the third quarter of 2024 and 14% year-to-date due to lower demand driven by generic erosion.

Previous wording

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 86% of total gross sales of U.S. products during the six months ended June 30, 2024. 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.

Current wording

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 85% of total gross sales of U.S. products during the nine months ended September 30, 2024. 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.

Previous wording

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 six months ended June 30, 2024 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.

Current wording

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 nine months ended September 30, 2024 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 Annual report on Form 10-K.

Previous wording

Cost of products sold increased by $391 million in the second quarter of 2024 and $757 million year-to-date primarily due to an impairment charge related to Inrebic ($280 million), higher profit sharing and royalty expense ($144 million and $295 million) and higher sales volume.

Current wording

Cost of products sold increased by $451 million in the third quarter of 2024 and $1.2 billion year-to-date primarily due to higher profit sharing and royalty expense ($246 million and $565 million) and higher sales volume. Year-to-date 2024 also includes a $280 million impairment charge related to Inrebic.

Previous wording

Marketing, selling and administrative expense increased by $599 million year-to-date primarily due to the impact of recent acquisitions ($507 million, including the cash settlement of unvested stock awards and other related expenses of $372 million) and timing of charitable giving ($150 million).

Current wording

Marketing, selling and administrative expense increased by $579 million year-to-date primarily due to the impact of recent acquisitions in 2024, including the cash settlement of unvested stock awards and other related expenses of $372 million.

Previous wording

Research and development expense increased by $641 million in the second quarter of 2024 and $1.0 billion year-to-date primarily due to an IPRD impairment charge relating to alnuctamab ($590 million) and the impact of recent acquisitions ($197 million in the second quarter and $648 million year-to-date). Year-to-date 2024 impact from acquisitions includes the cash settlement of unvested stock awards and other related expenses of $348 million.

Current wording

Research and development expense increased by $1.1 billion year-to-date primarily due to an IPRD impairment charge relating to alnuctamab ($590 million) and the impact of recent acquisitions, including cash settlement of unvested stock awards and other related expenses of $348 million.

Previous wording

Amortization of acquired intangible assets increased by $159 million in the second quarter of 2024 and $260 million year-to-date primarily due to the intangible assets acquired through the RayzeBio acquisition in the first quarter of 2024 and FDA approval of Augtyro in the fourth quarter of 2023.

Current wording

Amortization of acquired intangible assets increased by $150 million in the third quarter of 2024 and $410 million year-to-date primarily due to the intangible assets acquired through the RayzeBio acquisition in the first quarter of 2024 and FDA approval of Augtyro in the fourth quarter of 2023.

Previous wording

Other (income)/expense, net changed by $389 million in the second quarter of 2024 and $883 million year-to-date as discussed below.

Current wording

Other (income)/expense, net changed by $492 million in the third quarter of 2024 and $1.4 billion year-to-date as discussed below.

Previous wording

•Interest expense increased in the second quarter of 2024 and year-to-date compared to 2023 due to additional borrowings. Refer to "Item 1. Financial Statements—Note 10. Financing Arrangements" for further information.

Current wording

•Interest expense increased in the third quarter of 2024 and year-to-date due to additional borrowings. Refer to "Item 1. Financial Statements—Note 10. Financing Arrangements" for further information.