Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

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Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

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 footnotes included elsewhere in this Quarterly Report on Form 10-Q to enhance the understanding of our results of operations, financial condition and cash flows.

EXECUTIVE SUMMARY

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.

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 KRASG12C-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.

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".

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.

Financial Highlights

Three Months Ended September 30,Nine Months Ended September 30,
Dollars in millions, except per share data2024202320242023
Total Revenues$11,892$10,966$35,958$33,529
Diluted earnings/(loss) per share
GAAP$0.60$0.93$(4.45)$2.99
Non-GAAP1.802.00(0.53)5.80

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 Sprycel due to generic erosion*.* Year-to-date was also partially offset by Revlimid.

The $0.33 decrease in GAAP EPS and the $0.20 decrease in non-GAAP EPS for the third quarter of 2024 were primarily driven by higher interest expense and a lower effective income tax rate in 2023, partially offset by higher revenues.

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.

Our non-GAAP financial measures, including non-GAAP earnings and related EPS information, are adjusted to exclude specified items that represent certain costs, expenses, gains and losses and other items impacting the comparability of financial results. For further information and reconciliations relating to our non-GAAP financial measures refer to "—Non-GAAP Financial Measures."

Economic and Market Factors

Governmental Actions

As regulators continue to focus on prescription drugs, our products are facing increased pressures across the portfolio. These pressures stem from legislative and policy changes, including price controls, pharmaceutical market access, discounting, changes to tax and importation laws and other restrictions in the U.S., EU and other regions around the world. These pressures have resulted in lower prices, lower reimbursement rates and smaller populations for whom payers will reimburse, which 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.

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.

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.

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.

Significant Product and Pipeline Approvals

The following is a summary of the significant approvals received in 2024 as of October 31, 2024:

ProductDateApproval
OpdivoOctober 2024FDA 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 (KarXT; xanomeline and trospium chloride)September 2024FDA approval of Cobenfy for the treatment of schizophrenia in adults.
AugtyroSeptember 2024Japan's Ministry of Health, Labour and Welfare approval of Augtyro for the treatment of patients with ROS1 fusion-positive, unresectable advanced or recurrent NSCLC.
BreyanziAugust 2024Japan'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.
KrazatiJune 2024FDA accelerated approval for Krazati in combination with cetuximab as a targeted treatment option for adult patients with KRASG12C-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.
AugtyroJune 2024FDA 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.
OpdivoMay 2024EC approval of Opdivo in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
BreyanziMay 2024FDA 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.
BreyanziMay 2024FDA 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.
AbecmaApril 2024FDA 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.
ReblozylApril 2024EC 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.
AbecmaMarch 2024EC 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.
BreyanziMarch 2024FDA 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.
OpdivoMarch 2024FDA approval of Opdivo, in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
ReblozylJanuary 2024Japan'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 a listing of other developments in our marketed products and late-stage pipeline since the start of the third quarter of 2024.

Acquisitions, Divestitures, Licensing and Other Arrangements

Refer to "Item 1. Financial Statements—Note 3. Alliances" and "—Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements" for information on significant acquisitions, divestitures, licensing and other arrangements.

RESULTS OF OPERATIONS

Regional Revenues

The composition of the changes in revenues was as follows:

Three Months Ended September 30,Nine Months Ended September 30,
Dollars in millions20242023% ChangeForeign Exchange**(b)**20242023% ChangeForeign Exchange**(b)**
United States$8,232$7,5429%—%$25,509$23,2989%—%
International3,3893,2395%(4)%9,8039,7161%(5)%
Other(a)27118546%N/A64651525%N/A
Total$11,892$10,9668%(2)%$35,958$33,5297%(2)%

(a) Other revenues include royalties and alliance-related revenues for products not sold by our regional commercial organizations.

(b) Foreign exchange impacts were derived by applying the prior period average currency rates to the current period sales.

United States

  • 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 Sprycel due to generic erosion. Average U.S. net selling prices decreased 1% year-to-date compared to the same period a year ago.

International

  • 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.

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.

GTN Adjustments

The reconciliation of gross product sales to net product sales by each significant category of GTN adjustments was as follows:

Three Months Ended September 30,Nine Months Ended September 30,
Dollars in millions20242023% Change20242023% Change
Gross product sales$21,223$18,64814%$61,298$54,04713%
GTN adjustments
Charge-backs and cash discounts(2,967)(2,373)25%(8,366)(6,743)24%
Medicaid and Medicare rebates(4,577)(3,730)23%(11,525)(9,355)23%
Other rebates, returns, discounts and adjustments(2,196)(1,900)16%(6,440)(5,339)21%
Total GTN adjustments(9,740)(8,003)22%(26,331)(21,437)23%
Net product sales$11,483$10,6458%$34,967$32,6107%
GTN adjustments percentage46%43%3%43%40%3%
U.S.52%49%3%48%45%3%
Non-U.S.20%20%—%20%20%—%

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.

Product Revenues

Three Months Ended September 30,Nine Months Ended September 30,
Dollars in millions20242023% Change20242023% Change
Growth Portfolio
Opdivo$2,360$2,2754%$6,825$6,6223%
U.S.1,3661,3432%3,9273,8452%
Non-U.S.9949327%2,8982,7774%
Orencia9369251%2,6822,6163%
U.S.706708—%2,0201,9543%
Non-U.S.2302176%662662—%
Yervoy64257911%1,8551,67211%
U.S.39935911%1,1711,03913%
Non-U.S.24322010%6846338%
Reblozyl44724880%1,22668878%
U.S.35820079%99953487%
Non-U.S.894885%22715447%
Opdualag23316640%67443754%
U.S.21616233%63742948%
Non-U.S.174>200%378>200%
Abecma1249333%301372(19)%
U.S.776912%183302(39)%
Non-U.S.472496%1187069%
Zeposia14712320%40830136%
U.S.1059511%28821932%
Non-U.S.422850%1208246%
Breyanzi22492143%48426384%
U.S.17377125%38221875%
Non-U.S.5115>200%10245127%
Camzyos15668129%379143165%
U.S.13567101%342142141%
Non-U.S.211>200%371>200%
Sotyktu6666—%16310752%
U.S.5162(18)%12610125%
Non-U.S.154>200%376>200%
Augtyro10—N/A23—N/A
U.S.10—N/A23—N/A
Non-U.S.——N/A——N/A
Krazati34—N/A87—N/A
U.S.32—N/A82—N/A
Non-U.S.2—N/A5—N/A
Other Growth Products(a)43331139%1,09388623%
U.S.17214915%4884557%
Non-U.S.26116261%60543140%
Total Growth Portfolio$5,812$4,94618%$16,200$14,10715%
U.S.3,8003,29115%10,6689,23815%
Non-U.S.2,0121,65522%5,5324,86914%
Three Months Ended September 30,Nine Months Ended September 30,
Dollars in millions20242023% Change20242023% Change
Legacy Portfolio
Eliquis$3,002$2,70511%$10,138$9,3329%
U.S.2,0451,77215%7,4106,61012%
Non-U.S.9579333%2,7282,722—%
Revlimid1,4121,429(1)%4,4344,647(5)%
U.S.1,2121,209—%3,8303,951(3)%
Non-U.S.200220(9)%604696(13)%
Pomalyst/Imnovid8988723%2,7222,5517%
U.S.69760615%2,0101,71217%
Non-U.S.201266(24)%712839(15)%
Sprycel290517(44)%1,0881,404(23)%
U.S.225399(44)%8481,011(16)%
Non-U.S.65118(45)%240393(39)%
Abraxane253260(3)%701757(7)%
U.S.151178(15)%450526(14)%
Non-U.S.1028224%2512319%
Other Legacy Products(b)225237(5)%675731(8)%
U.S.1028717%29325017%
Non-U.S.123150(18)%382481(21)%
Total Legacy Portfolio$6,080$6,0201%$19,758$19,4222%
U.S.4,4324,2514%14,84114,0606%
Non-U.S.1,6481,769(7)%4,9175,362(8)%
Total Revenues$11,892$10,9668%$35,958$33,5297%
U.S.8,2327,5429%25,50923,2989%
Non-U.S.(c)3,6603,4247%10,44910,2312%

(a) Includes Onureg, Inrebic, Nulojix, Empliciti and royalty revenues.

(b) Includes other mature brands.

(c) Includes International and Other.

Growth Portfolio

Opdivo (nivolumab) — a fully human monoclonal antibody that binds to the PD-1 on T and NKT cells. It has been approved for several anti-cancer indications including bladder, blood, CRC, head and neck, RCC, HCC, lung, melanoma, MPM, stomach and esophageal cancer. The Opdivo+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.

  • U.S. revenues increased 2% during the third quarter of 2024 and year-to-date primarily due to higher average net selling prices, partially offset by lower demand.

  • 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.

Orencia (abatacept) — a fusion protein indicated for adult patients with moderate to severe active RA and PsA and is also indicated for reducing signs and symptoms in certain pediatric patients with moderately to severely active polyarticular JIA and for the treatment of aGVHD, in combination with a calcineurin inhibitor and methotrexate.

  • U.S. revenues were relatively flat during the third quarter of 2024 due to higher demand offset by lower average net selling prices.

  • U.S. revenues increased 3% year-to-date primarily due to higher demand, partially offset by lower average net selling prices.

  • International revenues increased 6% during the third quarter of 2024 due to higher demand and average net selling price, partially offset by foreign exchange impacts of 7%. Excluding foreign exchange impacts, revenues increased by 13%.

  • International revenues were flat year-to-date due to higher demand offset by foreign exchange impacts of 8%. Excluding foreign exchange impacts, revenues increased 8%.

  • BMS is not aware of any Orencia biosimilars on the market in the U.S., EU and Japan. Formulation and additional patents expire in 2026 and beyond.

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, CRC and esophageal cancer.

  • U.S. revenues increased 11% during the third quarter of 2024 and 13% year-to-date due to higher demand and higher average net selling prices.

  • 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.

Reblozyl (luspatercept-aamt) — an erythroid maturation agent indicated for the treatment of anemia in adult patients with lower risk myelodysplastic syndrome and beta thalassemia.

*•*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.

  • International revenues increased 85% during the third quarter of 2024 and 47% year-to-date due to higher demand, partially offset by foreign exchange impacts of 5% and 3%, respectively. Excluding foreign exchange impacts, revenues increased by 90% and 50%, respectively.

Opdualag (nivolumab and relatlimab-rmbw) — a combination of nivolumab, a PD-1 blocking antibody, and relatlimab, a LAG-3 blocking antibody, indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.

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

Abecma (idecabtagene vicleucel) — a BCMA genetically modified autologous CAR–T cell therapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-cyclic ADP ribose hydrolase monoclonal antibody.

*•*U.S. revenues 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.

Zeposia (ozanimod) — an oral immunomodulatory drug used to treat relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults and to treat moderately to severely active UC in adults.

*•*U.S. revenues increased 11% during the third quarter of 2024 and 32% year-to-date primarily due to higher demand.

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 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.

Camzyos (mavacamten) — a cardiac myosin inhibitor indicated for the treatment of adults with symptomatic obstructive HCM to improve functional capacity and symptoms. Camzyos was launched in April 2022.

*•*U.S. revenues increased 101% during the third quarter of 2024 and 141% year-to-date, primarily due to higher demand.

Sotyktu (deucravacitinib) — an oral, selective, allosteric tyrosine kinase 2 inhibitor indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Sotyktu was launched in September 2022.

*•*U.S. revenues decreased 18% during the third quarter of 2024 primarily due to comparator sales for use in clinical trials during the third quarter of 2023 and lower average net selling prices, partially offset by higher demand.

  • U.S. revenues increased 25% year-to-date, primarily due to higher demand, partially offset by comparator sales for use in clinical trials during the third quarter of 2023 and lower average net selling prices.

Augtyro (repotrectinib) — a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC and for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have NTRK 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. Augtyro was launched in November 2023.

Krazati (adagrasib) — a highly selective and potent oral small-molecule inhibitor of the KRASG12C mutation, indicated for the treatment of adult patients with KRASG12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy and, in combination with cetuximab, for the treatment of adult patients with KRASG12C-mutated locally advanced or metastatic CRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. Krazati was brought into the BMS portfolio as part of the Mirati acquisition completed in 2024.

Cobenfy (xanomeline and trospium chloride) – a combination M1 / M4 muscarinic receptor agonist and muscarinic antagonist indicated for the treatment of schizophrenia in adults. Cobenfy was approved by the FDA in September 2024.

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

Legacy Portfolio

Eliquis (apixaban) — an oral Factor Xa inhibitor indicated for the reduction in risk of stroke/systemic embolism in NVAF and for the treatment of DVT/PE and reduction in risk of recurrence following initial therapy.

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

*•*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.

  • 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. 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 (lenalidomide) — an oral immunomodulatory drug that in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma. Revlimid as a single agent is also indicated as a maintenance therapy in patients with multiple myeloma following autologous hematopoietic stem cell transplant. Revlimid has received approvals for several indications in the hematological malignancies including lymphoma and MDS.

*•*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.

*•*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.

  • In the U.S., certain third parties were granted volume-limited licenses to sell generic lenalidomide beginning in March 2022 or thereafter. Pursuant to these licenses, several generics have entered or are expected to enter the U.S. market with volume-limited quantities of generic lenalidomide. In the EU and Japan, generic lenalidomide products have entered the market.

Pomalyst/Imnovid (pomalidomide) — a proprietary, distinct, small molecule that is administered orally and modulates the immune system and other biologically important targets. Pomalyst/Imnovid is indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.

*•*U.S. revenues 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.

*•*International revenues decreased 24% during the third quarter of 2024 and 15% year-to-date primarily due to generic erosion and year-to-date foreign exchange impact of 1%. Excluding foreign exchange impacts, revenues decreased by 24% and 14%, respectively.

  • In the EU, generic pomalidomide products entered the market in August 2024.

Sprycel (dasatinib) — an oral inhibitor of multiple tyrosine kinase indicated for the first-line treatment of patients with Philadelphia chromosome-positive CML in chronic phase and the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase CML with resistance or intolerance to prior therapy, including Gleevec* (imatinib mesylate) and the treatment of children and adolescents aged 1 year to 18 years with chronic phase Philadelphia chromosome-positive CML.

*•*U.S. revenues decreased 44% during the third quarter of 2024 primarily due to lower average net selling price and generic erosion.

*•*U.S. revenues decreased 16% year-to-date primarily due to lower average net selling price and generic erosion, partially offset by higher demand during the first half of the year.

*•*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.

  • 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.

Abraxane (paclitaxel albumin-bound particles for injectable suspension) — a solvent-free protein-bound chemotherapy product that combines paclitaxel with albumin using our proprietary Nab® technology platform, and is used to treat breast cancer, NSCLC and pancreatic cancer, among others.

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

Other Legacy Portfolio Products — includes other mature brands.

Estimated End-User Demand

Pursuant to the SEC Consent Order described under "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operation— SEC Consent Order" in our 2023 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 September 30, 2024, for our U.S. distribution channels, and as of June 30, 2024, 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 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.

Camzyos is only available through a restricted program called the Camzyos REMS Program. Product distribution is limited to REMS certified pharmacies, and enrolled pharmacies must only dispense to patients who are authorized to receive Camzyos. Revlimid and Pomalyst are distributed in the U.S. primarily through contracted pharmacies under the Lenalidomide REMS (Revlimid) and Pomalyst REMS programs, respectively. These are proprietary risk-management distribution programs tailored specifically to provide for the safe and appropriate distribution and use of Revlimid and Pomalyst. Internationally, Revlimid and Imnovid are distributed under mandatory risk-management distribution programs tailored to meet local authorities' specifications to provide for the products' safe and appropriate distribution and use. These programs may vary by country and, depending upon the country and the design of the risk-management program, the product may be sold through hospitals or retail pharmacies.

Our non-U.S. businesses have significantly more direct customers. Information on available direct customer product level inventory and corresponding out-movement information and the reliability of third-party demand information varies widely. We limit our direct customer sales channel inventory reporting to where we can influence demand. When this information does not exist or is otherwise not available, we have developed a variety of methodologies to estimate such data, including using historical sales made to direct customers and third-party market research data related to prescription trends and end-user demand. Given the difficulties inherent in estimating third-party demand information, we evaluate our methodologies to estimate direct customer product level inventory and to calculate months on hand on an ongoing basis and make changes as necessary. Factors that may affect our estimates include generic competition, seasonality of products, price increases, new product launches, new warehouse openings by direct customers, new customer stockings by direct customers and expected direct customer purchases for governmental bidding situations. As such, all of the information required to estimate months on hand in the direct customer distribution channel for non-U.S. business 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.

Expenses

Three Months Ended September 30,Nine Months Ended September 30,
Dollars in millions20242023% Change20242023% Change
Cost of products sold(a)$2,957$2,50618%$9,156$7,94815%
Marketing, selling and administrative1,9832,003(1)%6,2785,69910%
Research and development2,3742,2426%7,9686,82117%
Acquired IPRD26280*13,343313*
Amortization of acquired intangible assets2,4062,2567%7,1796,7696%
Other (income)/expense, net234(258)*588(787)*
Total Expenses$10,216$8,82916%$44,512$26,76366%
  • In excess of +/- 100%.

(a) Excludes amortization of acquired intangible assets.

Cost of Products Sold

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.

Marketing, Selling and Administrative

Marketing, selling and administrative expense decreased by $20 million in the third quarter of 2024.

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.

Research and Development

Research and development expense increased by $132 million in the third quarter of 2024 primarily due to the impact of recent acquisitions.

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.

Acquired IPRD

Acquired IPRD charges resulting from upfront or contingent milestone payments in connection with asset acquisitions or licensing of third-party intellectual property rights were as follows:

Three Months Ended September 30,Nine Months Ended September 30,
Dollars in millions2024202320242023
Karuna asset acquisition (Note 4)$—$—$12,122$—
RayzeBio rights buy-out92—92—
SystImmune upfront fee (Note 3)——800—
Evotec designation and opt-in license fees125—17090
Prothena opt-in license fee——8055
Other458079168
Acquired IPRD$262$80$13,343$313

Amortization of Acquired Intangible Assets

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.

Other (Income)/Expense, Net

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

Three Months Ended September 30,Nine Months Ended September 30,
Dollars in millions2024202320242023
Interest expense$505$280$1,451$850
Royalty and licensing income(180)(365)(532)(1,068)
Royalty income - divestitures(284)(217)(820)(623)
Investment income(94)(107)(364)(304)
Litigation and other settlements—(61)71(393)
Provision for restructuring78141558321
Integration expenses6954214180
Equity investment (gain)/losses(12)—(221)213
Acquisition expenses——50—
Intangible asset impairments47294729
Other105(12)1348
Other (income)/expense, net$234$(258)$588$(787)
  • 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.

  • Royalty income decreased in the third quarter of 2024 and year-to-date primarily due to lower royalty rates for Keytruda* starting in 2024, partially offset by higher royalties from diabetes business divestitures in 2024. Refer to "Item 1. Financial Statements—Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements" for further information.

  • Investment income is primarily driven by changes in average cash and marketable debt securities balances.

*•*Litigation and other settlements includes amounts related to pricing, sales and promotional practices disputes and securities litigation matters, partially offset by income from the Eisai collaboration termination in 2024. Refer to "Item 1. Financial Statements—Note 3. Alliances" and "Item 1. Financial Statements —Note 18. Legal Proceedings and Contingencies" for further information. Third quarter of 2023 includes income related to the AstraZeneca settlement, partially offset by expense recorded in connection with the BeiGene settlement. Year-to-date 2023 includes income related to the Nimbus' TYK2 program change of control provision and additional settlement costs related to commercial disputes regarding intellectual property matters. Refer to "Item 1. Financial Statements—Note 5. Other (Income)/Expense, Net" for further information.

  • Provision for restructuring includes exit and other costs primarily related to certain restructuring activities including the plans discussed further in "Item 1. Financial Statements—Note 6. Restructuring".

  • Integration expenses increased in the third quarter of 2024 and year-to-date primarily due to Celgene and other acquisitions.

  • Equity investments generated gains year-to-date in 2024 compared to losses in 2023 primarily driven by fair value adjustments for investments that have readily determinable fair value. Refer to "Item 1. Financial Statements—Note 9. Financial Instruments and Fair Value Measurements" for more information.

  • Acquisition expenses primarily includes investment banking and professional advisory fees.

  • Other includes pension settlement charges of $100 million and $119 million for the third quarter of 2024 and year-to-date, respectively, related to the termination of the Bristol-Myers Squibb Puerto Rico, Inc. Retirement Income pension plan.

Income Taxes

Three Months Ended September 30,Nine Months Ended September 30,
Dollars in millions2024202320242023
Earnings/(Loss) before income taxes$1,676$2,137$(8,554)$6,766
Income tax provision461203455488
Effective tax rate27.5%9.5%(5.3)%7.2%
Impact of specified items9.0%(2.1)%(193.7)%(7.5)%
Effective tax rate excluding specified items18.5%11.6%188.4%14.7%

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 effective tax rate for the third quarter of 2024 was primarily impacted by changes in previously estimated annual effective tax rates resulting from jurisdictional earnings mix. The effective tax rate for the third quarter of 2023 was primarily impacted by revised guidance regarding deductibility of certain research and development expenses which reduced income taxes by approximately $160 million and was the primary reason for a $240 million reduction to previously estimated income taxes for 2022 upon finalization of the U.S. federal income tax return.

Excluding the impact of specified items, the effective tax rate increased from 11.6% to 18.5% in the third quarter of 2024, primarily due to the aforementioned jurisdictional earnings mix and revised guidance regarding deductibility of certain research and development expenses.

The year-to-date 2024 effective tax rate was primarily impacted by a $12.1 billion one-time, non-tax deductible charge for the acquisition of Karuna and releases of income tax reserves of $644 million related to the resolution of Celgene's 2017-2019 IRS audit. The Karuna non-tax deductible charge affected the effective tax rate as well as the effective tax rate excluding specified items. In addition, the effective tax rate was impacted by jurisdictional earnings mix resulting from amortization of acquired intangible assets, foreign currency changes on certain net operating loss and other carryforwards in 2024, and other specified items.

The year-to-date 2023 effective tax rate was primarily impacted by 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, jurisdictional earnings mix resulting from amortization of acquired intangible assets, equity investment losses, litigation and other settlements, as well as releases of income tax reserves of $89 million related to the resolution of Celgene's 2009-2011 IRS audit.

Non-GAAP Financial Measures

Our non-GAAP financial measures, such as non-GAAP earnings and related EPS information, are adjusted to exclude certain costs, expenses, gains and losses and other specified items that are evaluated on an individual basis. These items are adjusted after considering their quantitative and qualitative aspects and typically have one or more of the following characteristics, such as being highly variable, difficult to project, unusual in nature, significant to the results of a particular period or not indicative of past or future operating results. These items are excluded from non-GAAP earnings and related EPS information because the Company believes they neither relate to the ordinary course of the Company's business nor reflect the Company's underlying business performance. Similar charges or gains were recognized in prior periods and will likely reoccur in future periods, including (i) amortization of acquired intangible assets, including product rights that generate a significant portion of our ongoing revenue and will recur until the intangible assets are fully amortized, (ii) unwinding of inventory purchase price adjustments, (iii) acquisition and integration expenses, (iv) restructuring costs, (v) accelerated depreciation and impairment of property, plant and equipment and intangible assets, (vi) costs of acquiring a priority review voucher, (vii) divestiture gains or losses, (viii) stock compensation resulting from acquisition-related equity awards, (ix) pension, legal and other contractual settlement charges, (x) equity investment and contingent value rights fair value adjustments (including fair value adjustments attributed to limited partnership equity method investments), (xi) income resulting from the change in control of the Nimbus TYK2 Program and (xii) 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. Certain other significant tax items are also excluded such as the impact resulting from a non-U.S. tax ruling regarding the deductibility of a statutory impairment of subsidiary investments and release of income tax reserves relating to the Celgene acquisition. We also provide international revenues for our priority products excluding the impact of foreign exchange. We calculate foreign exchange impacts by converting our current-period local currency financial results using the prior period average currency rates and comparing these adjusted amounts to our current-period results. Reconciliations of these non-GAAP measures to the most comparable GAAP measures are included in Exhibit 99.1 to our Form 8-K filed on October 31, 2024 and are incorporated herein by reference.

Non-GAAP information is intended to portray the results of our baseline performance, supplement or enhance management's, analysts' and investors’ overall understanding of our underlying financial performance and facilitate comparisons among current, past and future periods. This information is not intended to be considered in isolation or as a substitute for the related financial measures prepared in accordance with GAAP and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted. We encourage investors to review our financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure.

Specified items were as follows:

Three Months Ended September 30,Nine Months Ended September 30,
Dollars in millions2024202320242023
Inventory purchase price accounting adjustments$13$—$34$84
Intangible asset impairment——280—
Site exit and other costs881610553
Cost of products sold10116419137
Acquisition related charges(a)——372—
Site exit and other costs7651985
Marketing, selling and administrative76539185
IPRD impairments—6059080
Priority review voucher———95
Acquisition related charges(a)——348—
Site exit and other costs2143610
Research and development2164974185
Amortization of acquired intangible assets2,4062,2567,1796,769
Interest expense(b)(12)(12)(37)(39)
Litigation and other settlements—(62)61(397)
Provision for restructuring78141558321
Integration expenses6954214180
Equity investment (gain)/losses(13)(2)(222)206
Acquisition expenses——50—
Intangible asset impairment47294729
Other106(1)116(6)
Other (income)/expense, net275147787294
Increase to pretax income2,8102,5489,7507,470
Income taxes on items above(371)(340)(1,296)(944)
Income tax reserve releases——(502)—
Income taxes attributed to non-U.S. tax ruling———(656)
Income taxes(371)(340)(1,798)(1,600)
Increase to net earnings$2,439$2,208$7,952$5,870

(a) Includes cash settlement of unvested stock awards, and other related costs incurred in connection with the recent acquisitions.

(b) Includes amortization of purchase price adjustments to Celgene debt.

The reconciliations from GAAP to Non-GAAP were as follows:

Three Months Ended September 30,Nine Months Ended September 30,
Dollars in millions, except per share data2024202320242023
Net earnings/(loss) attributable to BMS
GAAP$1,211$1,928$(9,020)$6,263
Specified items2,4392,2087,9525,870
Non-GAAP$3,650$4,136$(1,068)$12,133
Weighted-average common shares outstanding – diluted2,0312,0642,0262,093
Diluted earnings/(loss) per share attributable to BMS
GAAP$0.60$0.93$(4.45)$2.99
Specified items1.201.073.922.81
Non-GAAP$1.80$2.00$(0.53)$5.80

FINANCIAL POSITION, LIQUIDITY AND CAPITAL RESOURCES

Our net debt position was as follows:

Dollars in MillionsSeptember 30, 2024December 31, 2023
Cash and cash equivalents$7,890$11,464
Marketable debt securities – current204816
Marketable debt securities – non-current324364
Total cash, cash equivalents and marketable debt securities8,41812,644
Short-term debt obligations(1,078)(3,119)
Long-term debt(48,674)(36,653)
Net debt position$(41,334)$(27,128)

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, 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 nine months ended September 30, 2024, our net debt position increased by $14.2 billion primarily driven by payments for acquisitions, collaborations and milestones of $21.8 billion and $3.6 billion of dividend payments, partially offset by cash provided by operations of $10.8 billion.

During the nine months ended September 30, 2024, we issued the 2024 Senior Unsecured Notes in an aggregate principal amount of $13.0 billion with proceeds, net of discount and loan issuance costs, of $12.9 billion. The proceeds from the 2024 Senior Unsecured Notes were used to partially fund the acquisitions of RayzeBio and Karuna, and the remaining net proceeds were used for general corporate purposes. In connection with the issuance of the 2024 Senior Unsecured Notes, we terminated the $10.0 billion 364-day senior unsecured delayed draw term loan facility entered in February 2024 to provide bridge financing for the RayzeBio and Karuna acquisitions.

During the nine months ended September 30, 2024, $2.5 billion 2.900% Notes and $395 million 3.625% Notes matured and were repaid.

Under our commercial paper program, we may issue a maximum of $7.0 billion of unsecured notes that have maturities of not more than 365 days from the date of issuance. During the first quarter of 2024, we issued $3.0 billion of commercial paper and such amount was fully repaid by the end of the third quarter of 2024.

There were no borrowings outstanding under our $5.0 billion revolving credit facility as of September 30, 2024 and December 31, 2023. This credit facility expires in January 2029 and is extendable annually by one year with the consent of the lenders. Additionally, in February 2024, we entered into a $2.0 billion 364-day revolving credit facility, under which no borrowings were outstanding as of September 30, 2024. The facilities provide for customary terms and conditions with no financial covenants and may be used to provide backup liquidity for our commercial paper borrowings.

Dividend payments were $3.6 billion during the nine months ended September 30, 2024. The decision to authorize dividends is made on a quarterly basis by our Board of Directors.

Annual capital expenditures are expected to be approximately $1.3 billion for the full year 2024. We continue to make capital expenditures in connection with the expansion of our manufacturing capabilities, research and development and other facility-related activities.

During the nine months ended September 30, 2024 and 2023, income tax payments were $3.1 billion and $4.1 billion, including $799 million and $567 million, respectively, for the transition tax following the TCJA enactment.

Cash Flows

The following is a discussion of cash flow activities:

Nine Months Ended September 30,
Dollars in millions20242023
Cash flow provided by/(used in):
Operating activities$10,751$9,608
Investing activities(21,156)(949)
Financing activities$6,769$(10,383)

Operating Activities

The $1.1 billion increase in cash provided by operating activities compared to 2023, was primarily due to higher customer collections, net of rebates and discounts and alliance payments ($2.6 billion) and lower income tax payments ($1.0 billion), partially offset by acquisition-related expenses, including cash settlement of unvested stock awards ($1.0 billion), and higher interest payments on debt ($500 million), as well as timing of payments in the ordinary course of business.

Investing Activities

The $20.2 billion increase in cash used in investing activities compared to 2023 was due to higher acquisition-related expenses of $21.2 billion, as well as collaboration and milestone payments, partially offset by changes in the amount of marketable debt securities held of $1.0 billion.

Financing Activities

The $17.2 billion change in cash provided by financing activities compared to 2023 was primarily due to net debt borrowings of $10.5 billion in 2024 primarily to fund our acquisitions compared to $5.2 billion repurchases of common stock and net debt repayments of $1.6 billion in 2023.

Product and Pipeline Developments

Our R&D programs are managed on a portfolio basis from early discovery through late-stage development and include a balance of early-stage and late-stage programs to support future growth. Our late-stage 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 third quarter of 2024 as of October 31, 2024:

ProductIndicationDateDevelopments
AbecmaMultiple MyelomaSeptember 2024Announced the discontinuation of enrollment in the Phase 3 KarMMa-9 study investigating Abecma with lenalidomide maintenance versus lenalidomide maintenance alone in patients with newly diagnosed multiple myeloma who have suboptimal response after autologous stem cell transplant.
AugtyroNSCLCSeptember 2024Announced that Japan’s Ministry of Health, Labour and Welfare granted manufacturing and marketing approval for Augtyro for the treatment of patients with ROS1 fusion-positive, unresectable advanced or recurrent NSCLC. This approval is based on results from the Phase 1/2 TRIDENT-1 trial.
BreyanziFollicular Lymphoma (FL)August 2024Announced that Japan's Ministry of Health, Labour and Welfare approved the supplemental NDA for 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 based on results of the TRANSCEND FL study.
August 2024Announced EMA validation of the Type II variation application to expand the indication for Breyanzi to include the treatment of adult patients with relapsed or refractory FL who have received two or more prior lines of systemic therapy. The application is based on results of the Phase II TRANSCEND FL study. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.
CamzyosoHCMSeptember 2024Announced new long-term follow-up results from the EXPLORER-LTE cohort of the MAVA-Long-Term Extension study evaluating Camzyos in adult patients with New York Heart Association (NYHA) class II-III symptomatic obstructive hypertrophic cardiomyopathy demonstrating that patients experienced consistent and sustained improvements in echocardiographic measures and biomarkers after up to 3.5 years of continuous treatment. Patients experienced an improvement in symptoms and functional capacity as measured by NYHA class and patient-reported outcomes. The safety profile of Camzyos for up to 3.5 years remained consistent with the established safety profile and no new safety signals were identified.
July 2024Announced that the Japanese New Drug Application for Camzyos was accepted by the Pharmaceuticals and Medical Devices Agency for the treatment of obstructive hypertrophic cardiomyopathy. This filing is based on results from the global Phase 3 EXPLORER-HCM and Phase 3 VALOR-HCM trials, as well as the Japan Phase 3 HORIZON-HCM study.
cendakimabEosinophilic EsophagitisJuly 2024Announced that the results from the Phase 3 trial evaluating the efficacy and safety of cendakimab in patients with eosinophilic esophagitis met both co-primary endpoints, demonstrating statistically significant reductions versus placebo in symptoms (dysphagia days) and esophageal eosinophil counts after 24 weeks of treatment. The overall safety profile of cendakimab through 48 weeks of treatment in the Phase 3 trial was consistent with previously reported eosinophilic esophagitis Phase 2 trial results, and no new safety signals were identified.
Cobenfy (KarXT; xanomeline and trospium chloride)SchizophreniaSeptember 2024Announced FDA approval of Cobenfy for the treatment of schizophrenia in adults. The approval is based on data from the EMERGENT clinical program, which includes three placebo-controlled efficacy and safety trials and two open-label trials evaluating the long-term safety and tolerability of Cobenfy for up to one year.
InrebicMyelofibrosisAugust 2024Announced that the Japanese New Drug Application for Inrebic has been submitted to the Pharmaceuticals and Medical Devices Agency for the treatment of myelofibrosis (MF). This filing is based on results from the global Phase 3 EFC12153 (Jakarta) study for 1L MF, the global Phase 2 ARD12181 (Jakarta-2) study for 2L MF, and the Japan Phase 1/2 FEDR-MF-003 study.
ProductIndicationDateDevelopments
OpdivoNSCLCOctober 2024Announced FDA approval of Opdivo for the treatment of adult patients with resectable (tumors ≥ 4cm or nod 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. The approval is based on results from the Phase 3CheckMate -77T trial.
Opdivo + YervoyMelanomaSeptember 2024Announced 10-year follow-up data from the Phase 3 CheckMate -067 trial that showed continued durable improvement in survival with first-line Opdivo plus Yervoy therapy and Opdivo monotherapy, versus Yervoy alone, in patients with previously untreated advanced or metastatic melanoma. With a minimum follow up of 10 years, median overall survival was 71.9 months with Opdivo plus Yervoy, the longest reported median overall survival in a Phase 3 advanced melanoma trial.
HCCAugust 2024Announced FDA acceptance of the supplemental BLA for Opdivo plus Yervoy as a potential first-line treatment for adult patients with unresectable hepatocellular carcinoma. The acceptance is based on results from the Phase 3 CheckMate -9DW trial. The FDA assigned a PDUFA goal date of April 21, 2025.
August 2024Announced that the supplemental Japanese New Drug Application for Opdivo plus Yervoy was accepted by the Pharmaceuticals and Medical Devices Agency for the treatment of unresectable first line hepatocellular carcinoma. This filing is based on results from the Phase 3 CheckMate -9DW study.
July 2024Announced EMA validation of the Type II variation application for Opdivo plus Yervoy as a potential first-line treatment option for adult patients with unresectable or advanced HCC who have not received prior systemic therapy. The application is based on results from the Phase 3 CheckMate -9DW trial.
Colorectal CancerOctober 2024Announced that the Phase 3 CheckMate -8HW trial evaluating Opdivo plus Yervoy compared to Opdivo monotherapy across all lines of therapy as a treatment for patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer met the dual primary endpoint of progression-free survival as assessed by Blinded Independent Central Review at a pre-specified interim analysis. Previously, Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in PFS compared to chemotherapy. Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in PFS compared to Opdivo monotherapy across all lines of therapy. The study is ongoing to assess various secondary endpoints, including overall survival. The safety profile for the combination of Opdivo plus Yervoy remained consistent with previously reported data, with no new safety signals identified.
September 2024Announced that the supplemental Japanese New Drug Application for Opdivo plus Yervoy was accepted by the Pharmaceuticals and Medical Devices Agency for the treatment of unresectable advanced or recurrent colorectal cancer with frequent microsatellite instability. This filing is based on results from the Phase 3 CheckMate -8HW study.
Urothelial CarcinomaOctober 2024Announced that the Phase 3 CheckMate -901 trial evaluating Opdivo plus Yervoy versus standard-of-care non-cisplatin-based chemotherapy in patients with unresectable or metastatic urothelial carcinoma who are ineligible for cisplatin-based chemotherapy, did not meet its primary endpoint of overall survival. The safety profile for Opdivo and Yervoy was consistent with previously reported data, with no new safety signals identified. Opdivo has previously shown clinical benefit across various stages of urothelial carcinoma. These results do not impact those data or approved indications.
ZeposiaMultiple SclerosisSeptember 2024Announced data from the Phase 3 DAYBREAK trial which demonstrated that decreased rates of brain volume loss were sustained in the open-label extension for patients treated with Zeposia for relapsing forms of multiple sclerosis. A separate DAYBREAK OLE safety analysis demonstrated declining or stable incidence rates of treatment-emergent adverse events, with relatively low rates of infections, serious infections and opportunistic infections over more than eight years of treatment with Zeposia.

Critical Accounting Policies

The preparation of financial statements requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenue and expenses. Our critical accounting policies are those that significantly impact our financial condition and results of operations and require the most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. Because of this uncertainty, actual results may vary from these estimates. For a discussion of our critical accounting policies, refer to "Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations" in our 2023 Form 10-K. There have been no material changes to our critical accounting policies during the nine months ended September 30, 2024. For information regarding the impact of recently adopted accounting standards, refer to "Item 1. Financial Statements—Note 1. Basis of Presentation and Recently Issued Accounting Standards."

Special Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q (including documents incorporated by reference) and other written and oral statements we make from time to time contain certain "forward-looking" statements within the meaning of Section 27A of the Securities Act, and Section 21E of the Exchange Act. You can identify these forward-looking statements by the fact they use words such as "should," "could," "expect," "anticipate," "estimate," "target," "may," "project," "guidance," "intend," "plan," "believe," "will" and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. One can also identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements are based on our current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These statements are likely to relate to, among other things, our goals, plans and objectives regarding our financial position, results of operations, cash flows, market position, product development, product approvals, sales efforts, expenses, performance or results of current and anticipated products, our business development strategy and in relation to our ability to realize the projected benefits of our acquisitions, alliances and other business development activities, the impact of any pandemic or epidemic on our operations and the development and commercialization of our products, potential laws and regulations to lower drug prices, market actions taken by private and government payers to manage drug utilization and contain costs, the expiration of patents or data protection on certain products, including assumptions about our ability to retain marketing exclusivity of certain products and the outcome of contingencies such as legal proceedings and financial results. No forward-looking statement can be guaranteed. This Quarterly Report on Form 10-Q, our 2023 Form 10-K, particularly under the section "Item 1A. Risk Factors," and our other filings with the SEC, include additional information on the factors that we believe could cause actual results to differ materially from any forward-looking statement.

Although we believe that we have been prudent in our plans and assumptions, no assurance can be given that any goal or plan set forth in forward-looking statements can be achieved and readers are cautioned not to place undue reliance on such statements, which speak only as of the date made. Additional risks that we may currently deem immaterial or that are not presently known to us could also cause the forward-looking events discussed in this Quarterly Report on Form 10-Q not to occur. Except as otherwise required by applicable law, we undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise after the date of this Quarterly Report on Form 10-Q.

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