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 (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 a 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.

In 2024, we achieved significant advances in the CAR-T cell therapy arena with the approval of Abecma in the U.S. and EU for triple-class exposed relapsed and refractory multiple myeloma, and Breyanzi in the U.S. for adults with relapsed or refractory CLL or SLL. In addition, in oncology, Opdivo in combination with cisplatin and gemcitabine was approved in the U.S. for first-line treatment of adult patients with unresectable or metastatic muscle invasive urothelial carcinoma and 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. Refer to "—Product and Pipeline Developments" for additional updates on our pipeline.

Additionally, we completed the following acquisitions: (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 compound in a Phase I clinical trial, which is currently being evaluated for the treatment of metastatic or unresectable NSCLC. 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 are executing 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 March 31,
Dollars in millions, except per share data			2024						2023
Total Revenues			$	11,865					$	11,337
Diluted (loss)/earnings per share
GAAP			$	(5.89)					$	1.07
Non-GAAP			(4.40)						2.05

Revenues increased by 5% for the first quarter of 2024 due to the Growth Portfolio (primarily Reblozyl) and Eliquis, partially offset by Opdivo and Revlimid. The $6.96 decrease in GAAP EPS 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 the cash settlement of unvested stock awards and lower litigation and other settlement income ($0.51). After adjusting for specified items, the $6.45 decrease in non-GAAP EPS was primarily due to the aforementioned Acquired IPRD charges and higher operating and interest expense resulting from the recent acquisitions.

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

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.

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, such as those relating to calculating Medicaid Best Price, as well as 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.

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 potential legislative, policy, or administrative measures, we are unable to predict their full impact on our business. However, if implemented, these 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.

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 expected to make changes to their tax laws and updates to international tax treaties 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 April 25, 2024:

Product			Date			Approval

Abecma			April 2024			FDA approval of Abecma for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
Reblozyl			April 2024			EC expanded approval of Reblozyl to include the first-line treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk myelodysplastic syndromes.

Abecma			March 2024			EC approval of Abecma for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

Breyanzi			March 2024			FDA accelerated approval of Breyanzi for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor.

Opdivo			March 2024			FDA approval of Opdivo, in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic UC.
Reblozyl			January 2024			Japan's Ministry of Health, Labour and Welfare approval of Reblozyl for the treatment of anemia associated with myelodysplastic syndrome.

Refer to "—Product and Pipeline Developments" for a listing of other developments in our marketed products and late-stage pipeline since the start of the first 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 March 31,
Dollars in millions			2024						2023						% Change						Foreign Exchange**(b)**
United States			$	8,476					$	7,952					7		%				N/A
International			3,190						3,230						(1)		%				(4)		%
Other(a)			199						155						28		%				N/A
Total			$	11,865					$	11,337					5		%				(1)		%

(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 7% during the first quarter of 2024 primarily due to higher demand for Growth and Legacy Portfolio products, partially offset by lower average net selling prices for the Legacy Portfolio. Average U.S. net selling prices decreased 1% compared to the same period a year ago.

International

• International revenues decreased 1% during the first quarter of 2024 due to lower average net selling prices, partially offset by higher demand for the Growth Portfolio. The negative foreign exchange impact of 4% was primarily attributed to the 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 three months ended March 31, 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 March 31,
Dollars in millions			2024						2023						% Change
Gross product sales			$	19,295					$	17,288					12		%
GTN adjustments
Charge-backs and cash discounts			(2,556)						(2,091)						22		%
Medicaid and Medicare rebates			(3,084)						(2,482)						24		%
Other rebates, returns, discounts and adjustments			(2,096)						(1,667)						26		%
Total GTN adjustments			(7,736)						(6,240)						24		%
Net product sales			$	11,559					$	11,048					5		%
GTN adjustments percentage			40		%				36		%				4		%
U.S.			45		%				41		%				4		%
Non-U.S.			21		%				18		%				3		%

Reductions to provisions for product sales made in prior periods resulting from changes in estimates were $80 million and $87 million for the three months ended March 31, 2024 and for the three months ended March 31, 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 March 31,
Dollars in millions			2024						2023						% Change
Growth Portfolio
Opdivo			$	2,078					$	2,202					(6)		%
U.S.			1,155						1,281						(10)		%
Non-U.S.			923						921						—
Orencia			798						764						4		%
U.S.			572						551						4		%
Non-U.S.			226						213						6		%
Yervoy			583						508						15		%
U.S.			368						312						18		%
Non-U.S.			215						196						10		%
Reblozyl			354						206						72		%
U.S.			293						156						88		%
Non-U.S.			61						50						22		%
Opdualag			206						117						76		%
U.S.			198						116						71		%
Non-U.S.			8						1						*
Abecma			82						147						(44)		%
U.S.			52						118						(56)		%
Non-U.S.			30						29						3		%
Zeposia			110						78						41		%
U.S.			72						51						41		%
Non-U.S.			38						27						41		%
Breyanzi			107						71						51		%
U.S.			87						58						50		%
Non-U.S.			20						13						54		%
Camzyos			84						29						*
U.S.			77						29						*
Non-U.S.			7						—						N/A
Sotyktu			44						16						*
U.S.			34						15						*
Non-U.S.			10						1						*
Augtyro			6						—						N/A
U.S.			6						—						N/A
Non-U.S.			—						—						N/A
Krazati			21						—						N/A
U.S.			21						—						N/A
Non-U.S.			—						—						N/A
Other Growth Products(a)			319						280						14		%
U.S.			148						144						3		%
Non-U.S.			171						136						26		%
Total Growth Portfolio			$	4,792					$	4,418					8		%
U.S.			3,083						2,831						9		%
Non-U.S.			1,709						1,587						8		%

			Three Months Ended March 31,
Dollars in millions			2024						2023						% Change
Legacy Portfolio
Eliquis			$	3,720					$	3,423					9		%
U.S.			2,821						2,527						12		%
Non-U.S.			899						896						—
Revlimid			1,669						1,750						(5)		%
U.S.			1,453						1,523						(5)		%
Non-U.S.			216						227						(5)		%
Pomalyst/Imnovid			865						832						4		%
U.S.			597						541						10		%
Non-U.S.			268						291						(8)		%
Sprycel			374						429						(13)		%
U.S.			282						289						(2)		%
Non-U.S.			92						140						(34)		%
Abraxane			217						239						(9)		%
U.S.			145						161						(10)		%
Non-U.S.			72						78						(8)		%
Other Legacy Products (b)			228						246						(7)		%
U.S.			95						80						19		%
Non-U.S.			133						166						(20)		%
Total Legacy Portfolio			$	7,073					$	6,919					2		%
U.S.			5,393						5,121						5		%
Non-U.S.			1,680						1,798						(7)		%
Total Revenues			$	11,865					$	11,337					5		%
U.S.			8,476						7,952						7		%
Non-U.S.			3,389						3,385						—

• Change in excess of 100%.

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

(b) Includes other mature brands.

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 potentially registrational studies for Opdivo across other tumor types and disease areas, in monotherapy and in combination with Yervoy and various anti-cancer agents.

• U.S. revenues decreased 10% during the first quarter of 2024 primarily due to changes in sales channel inventory and timing of customer orders, partially offset by higher average net selling prices.

• International revenues were flat during the first quarter of 2024 and were driven by higher demand as a result of additional indication launches and core indications offset by foreign exchange impacts of 9%. Excluding foreign exchange impacts, revenues increased 9%.

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 increased 4% during the first quarter of 2024 primarily due to higher demand.

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

• 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 18% during the first quarter of 2024 due to higher demand and average net selling prices.

• International revenues increased 10% during the first quarter of 2024 due to higher demand, partially offset by foreign exchange impacts of 7% and lower average net selling prices. Excluding foreign exchange impacts, revenues increased by 17%.

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 88% during the first quarter of 2024 driven by higher demand due to a first line label extension in August 2023.

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 71% during the first quarter of 2024 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 four 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 decreased 56% during the first quarter of 2024 due to increased competition in BCMA targeted therapies.

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 41% during the first quarter of 2024 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 large B-cell lymphoma after one or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and FL grade 3B.

• U.S. revenues increased 50% during the first quarter of 2024 primarily due to higher demand.

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 more than doubled during the first quarter of 2024 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 more than doubled during the first quarter of 2024 primarily due to higher demand.

Augtyro (repotrectinib) — a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. Augtyro was launched in December 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. Krazati was launched in December 2022.

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 12% during the first quarter of 2024 primarily due to higher demand.

• International revenues were flat during the first quarter of 2024 due to higher demand offset by lower average net selling price and foreign exchange impact of 1%. Excluding foreign exchange impacts, revenues increased by 1%.

• Following the May 2021 expiration of regulatory exclusivity for Eliquis in Europe and the court decision in the UK finding the UK apixaban composition of matter patent and related SPC invalid, generic manufacturers have begun marketing generic versions of Eliquis in the UK and in Portugal, and may seek to market generic versions of Eliquis in additional countries in Europe, prior to the expiration of our patents, which has led to additional infringement and invalidity actions involving our Eliquis patents being filed in various countries in Europe. Most recently, in France, Norway, Sweden and Switzerland, courts held in BMS's favor, confirming the validity of the composition of matter patent and related SPCs in those countries. 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 decreased 5% during the first quarter of 2024 primarily due to lower average net selling prices.

• International revenues decreased 5% during the first quarter of 2024 primarily due to generic erosion across several European countries and foreign exchange impacts of 4%. Excluding foreign exchange impacts, revenues decreased by 1%.

• 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. Annual global revenues for Revlimid in 2024 are expected to be in the range of $4.5 billion to $5.0 billion.

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 10% during the first quarter of 2024 due to higher demand and average net selling prices.

• International revenues decreased 8% during the first quarter of 2024 primarily due to lower average net selling prices, lower demand and foreign exchange impacts of 1%. Excluding foreign exchange impacts, revenues decreased by 7%.

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 2% during the first quarter of 2024 due to lower average net selling prices.

• International revenues decreased 34% during the first quarter of 2024 primarily due to lower demand as a result of generic erosion, lower average net selling price and foreign exchange impacts of 4%. Excluding foreign exchange impacts, revenues decreased by 30%.

• 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 has been extended to 2024 for the treatment of non-imatinib-resistant CML, but generics have been approved for other indications.

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 10% during the first quarter of 2024 primarily due to lower average net selling prices, partially offset by higher demand.

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 March 31, 2024, for our U.S. distribution channels, and as of December 31, 2023, 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 84% of total gross sales of U.S. products during the three months ended March 31, 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 three months ended March 31, 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.

Expenses

			Three Months Ended March 31,
Dollars in millions			2024						2023						% Change
Cost of products sold(a)			$	2,932					$	2,566					14		%
Marketing, selling and administrative			2,367						1,762						34		%
Research and development			2,695						2,321						16		%
Acquired IPRD			12,949						75						*
Amortization of acquired intangible assets			2,357						2,256						4		%
Other (income)/expense, net			81						(413)						*
Total Expenses			$	23,381					$	8,567					*

• In excess of +/- 100%.

(a) Excludes amortization of acquired intangible assets.

Cost of Products Sold

Cost of products sold increased by $366 million in the first quarter of 2024 primarily due to higher product costs ($253 million) and higher profit sharing and royalty expense ($151 million) driven by product mix.

Marketing, Selling and Administrative

Marketing, selling and administrative expense increased by $605 million in the first quarter of 2024 primarily due to the impact of recent acquisitions ($426 million, including the cash settlement of unvested stock awards and other related expenses of $372 million) and timing of charitable giving ($160 million).

Research and Development

Research and development expense increased by $374 million in the first quarter of 2024 primarily due to the impact of recent acquisitions ($451 million, including the cash settlement of unvested stock awards and other related expenses of $348 million) and higher clinical grants and supplies ($91 million), partially offset by the purchase of a priority review voucher ($95 million) in 2023.

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 March 31,
Dollars in millions			2024						2023
Karuna asset acquisition (Note 4)			$	12,122					$	—
SystImmune upfront fee (Note 3)			800						—
Evotec designation and opt in license fee			25						50
Other			2						25
Acquired IPRD			$	12,949					$	75

Amortization of Acquired Intangible Assets

Amortization of acquired intangible assets increased by $101 million in the first quarter of 2024 primarily due to the intangible assets acquired through the Mirati and RayzeBio acquisitions and approval of Augtyro in the fourth quarter of 2023. The Revlimid acquired marketed product right will be fully amortized in the fourth quarter of 2024 resulting in an annual reduction of amortization expense of approximately $5.5 billion in 2025.

Other Expense/(Income), Net

Other (income)/expense, net changed by $494 million in the first quarter of 2024 primarily due to litigation and other settlements, equity investments, interest expense, and other items discussed below.

			Three Months Ended March 31,
Dollars in millions			2024						2023
Interest expense			$	425					$	288
Royalty and licensing income			(161)						(363)
Royalty income - divestitures			(271)						(188)
Investment income			(183)						(102)
Litigation and other settlements			2						(325)
Provision for restructuring			220						67
Integration expenses			71						67
Equity investment (gain)/losses			(102)						155
Acquisition expenses			49						—
Other			31						(12)
Other (income)/expense, net			$	81					$	(413)

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

• Royalty income decreased in the first quarter of 2024 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 increased during the first quarter of 2024 primarily due to higher average cash and marketable debt securities balances.

• Litigation and other settlements included $400 million of income related to the Nimbus' TYK2 program change of control provision and additional settlement costs related to commercial disputes regarding intellectual property matters in 2023. 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". The increase is primarily due to the recent acquisitions.

• Integration expenses increased in the first quarter of 2024 primarily due to the recent acquisitions.

• Equity investments generated gains in the first quarter of 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 in 2024 includes a $19 million settlement charge in connection with the termination of the Puerto Rico pension plan. The Company expects to record an additional settlement charge of approximately $100 million in the third quarter of 2024 when the plan is fully terminated.

Income Taxes

			Three Months Ended March 31,
Dollars in millions			2024						2023
Earnings before income taxes			$	(11,516)					$	2,770
Income tax provision			392						503
Effective tax rate			(3.4)		%				18.2		%
Impact of specified items			(5.6)		%				(2.7)		%
Effective tax rate excluding specified items			(9.0)		%				15.5		%

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 income tax provision of $392 million in the first quarter of 2024 on a pretax loss of $11.5 billion resulted in an effective tax rate of (3.4)% which included the impact of a $12.1 billion one-time, non-tax deductible charge for the acquisition of Karuna. This 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 the amortization of acquired intangible assets, foreign currency changes on certain net operating loss and other carryforwards in 2024, cash settlement of unvested stock awards and other specified items. The effective tax rate was also unfavorably impacted by changes in income tax reserves including an $89 million tax reserve release related to the resolution of Celgene’s 2009-2011 IRS audits in the first quarter of 2023, and to a lesser extent, the phased implementation of Pillar Two (global minimum tax) and lower excess tax benefits applicable to employee stock awards during the first quarter of 2024.

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) unwind 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 internal transfers of intangible and other assets to streamline our legal entity structure subsequent 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 April 25, 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 March 31,
Dollars in millions			2024						2023
Inventory purchase price accounting adjustments			$	8					$	53
Site exit and other costs			14						1
Cost of products sold			22						54
Acquisition related charges(a)			372						—
Site exit and other costs			6						—
Marketing, selling and administrative			378						—
IPRD impairments			—						20
Priority review voucher			—						95
Acquisition related charges(a)			348						—
Site exit and other costs			1						—
Research and development			349						115
Amortization of acquired intangible assets			2,357						2,256
Interest expense(b)			(13)						(14)
Litigation and other settlements			—						(335)
Provision for restructuring			220						67
Integration expenses			71						67
Equity investment (income)/losses			(102)						150
Acquisition expenses			49						—
Other			10						(5)
Other (income)/expense, net			235						(70)
Increase to pretax income			3,341						2,355
Income taxes on items above			(340)						(293)
Increase to net earnings			$	3,001					$	2,062

(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 March 31,
Dollars in millions, except per share data			2024						2023
Net (loss)/earnings attributable to BMS
GAAP			$	(11,911)					$	2,262
Specified items			3,001						2,062
Non-GAAP			$	(8,910)					$	4,324
Weighted-average common shares outstanding – diluted			2,023						2,113
Diluted (loss)/earnings per share attributable to BMS
GAAP			$	(5.89)					$	1.07
Specified items			1.49						0.98
Non-GAAP			$	(4.40)					$	2.05

FINANCIAL POSITION, LIQUIDITY AND CAPITAL RESOURCES

Our net debt position was as follows:

Dollars in Millions			March 31, 2024						December 31, 2023
Cash and cash equivalents			$	9,330					$	11,464
Marketable debt securities – current			340						816
Marketable debt securities – non-current			367						364
Total cash, cash equivalents and marketable debt securities			10,037						12,644
Short-term debt obligations			(6,190)						(3,119)
Long-term debt			(49,487)						(36,653)
Net debt position			$	(45,640)					$	(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 first quarter of 2024, our net debt position increased by $18.5 billion primarily driven by payments for recent acquisitions, collaborations and milestones of $20.1 billion and $1.2 billion of dividend payments, partially offset by cash provided by operations of $2.8 billion.

During the first quarter of 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.

Dividend payments were $1.2 billion during the three months ended March 31, 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 $1.4 billion in 2024 and 2025. We continue to make capital expenditures in connection with the expansion of our manufacturing capabilities, research and development and other facility-related activities.

There were no borrowings outstanding under our $5.0 billion revolving credit facility as of March 31, 2024 and December 31, 2023. In January 2024, we extended the credit facility to January 2029. Additionally, in February 2024, we entered into a $2.0 billion 364-day revolving credit facility. 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. No borrowings were outstanding under the $2.0 billion revolving credit facility as of March 31, 2024.

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. As of March 31, 2024, $3.0 billion was outstanding under the commercial paper program. In April 2024, $2.7 billion was repaid.

Cash Flows

The following is a discussion of cash flow activities:

			Three Months Ended March 31,
Dollars in millions			2024						2023
Cash flow provided by/(used in):
Operating activities			$	2,834					$	2,970
Investing activities			(19,618)						(210)
Financing activities			$	14,644					$	(3,050)

Operating Activities

The $136 million decrease in cash provided by operating activities compared to 2023 was primarily due to acquisition-related expenses, including cash settlement of unvested stock awards, of $600 million, partially offset by higher customer collections of $500 million (net of rebates and discounts).

Investing Activities

The $19.4 billion increase in cash used in investing activities compared to 2023 was due to $20.0 billion of higher acquisition, collaboration and milestone payments in 2024 partially offset by changes in the amount of marketable debt securities held of $616 million.

Financing Activities

The $17.7 billion increase in cash provided by financing activities compared to 2023 was primarily due to higher debt borrowings of $16.0 billion in 2024 to fund recent acquisitions compared to 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 first quarter of 2024 as of April 25, 2024:

Product			Indication			Date			Developments

Abecma			Multiple Myeloma			April 2024			Announced the FDA approval of Abecma for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. The approval is based on results from the Phase III KarMMa-3 trial. Abecma is being jointly developed and commercialized in the U.S. by Bristol Myers Squibb and 2seventy bio, Inc.
Multiple Myeloma			March 2024			Announced the EC approval of Abecma for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. The approval is based on results from the Phase III KarMMa-3 trial. Abecma is the first CAR-T cell immunotherapy approved in the EU for use in earlier lines of therapy for relapsed and refractory multiple myeloma.

Augtyro			Solid Tumor			February 2024			Announced FDA acceptance of the sNDA for Augtyro for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a NTRK gene fusion and are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity. The acceptance is based on results from the registrational Phase I/II TRIDENT-1 trial and the CARE study. The FDA granted the application priority review and assigned a PDUFA goal date of June 15, 2024.
NSCLC and Solid Tumor			January 2024			Announced EMA validation of the marketing authorization application for Augtyro as a treatment for ROS1 TKI-naïve and -pretreated adult patients with ROS1-positive locally advanced or metastatic NSCLC and TKI-naïve and -pretreated adult and pediatric patients 12 years and older with NTRK-positive locally advanced or metastatic solid tumors. The application was based on results from the registrational Phase I/II TRIDENT-1 trial and CARE study.

Product			Indication			Date			Developments

Breyanzi			Leukemia			March 2024			Announced accelerated FDA approval of Breyanzi for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor. The approval is based on the Phase I/II open-label, single-arm TRANSCEND CLL 004 trial.
Lymphoma			January 2024			Announced the FDA accepted sBLAs for Breyanzi to expand into new indications to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) and relapsed or refractory mantle cell lymphoma (MCL) after a Bruton tyrosine kinase inhibitor. The FDA granted both applications Priority Review and assigned a PDUFA goal date of May 23, 2024, for Breyanzi in relapsed or refractory FL and May 31, 2024, for Breyanzi in relapsed or refractory MCL. In addition, Japan's Ministry of Health, Labour and Welfare has also accepted the company's supplemental sNDA for Breyanzi for the treatment of relapsed or refractory FL. In relapsed or refractory FL, the applications for Breyanzi in the U.S. and Japan are based on results from the TRANSCEND FL study. In relapsed or refractory MCL, the application for Breyanzi in the U.S. is based on results from the MCL cohort of the TRANSCEND NHL 001 study.
KarXT			Schizophrenia			April 2024			Announced pooled interim long-term safety, tolerability, and metabolic outcomes data from the Phase III EMERGENT-4 and EMERGENT-5 trials evaluating the safety, tolerability and efficacy of KarXT in adults with schizophrenia. KarXT demonstrated a favorable weight and long-term metabolic profile where most patients experience stability or improvements on key metabolic parameters over 52 weeks of treatment. KarXT was generally well-tolerated with a side effect profile consistent with prior trials. In addition, announced interim long-term efficacy data from the Phase III EMERGENT-4 open-label extension trial demonstrated that KarXT was associated with significant improvement in symptoms of schizophrenia across all efficacy measures at 52 weeks.

Krazati			Colorectal Cancer			April 2024			Announced that data from the cohorts evaluating Krazati in combination with cetuximab of the Phase I/II KRYSTAL-1 study for the treatment of patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer demonstrated clinically meaningful activity. With a median follow up of 11.9 months in 94 patients, Krazati plus cetuximab demonstrated an objective response rate of 34%, median progression-free survival of 6.9 months, and median overall survival of 15.9 months in pre-treated patients.
NSCLC			March 2024			Announced that the results from the Phase III KRYSTAL-12 study evaluating Krazati as a monotherapy in patients with pretreated locally advanced or metastatic NSCLC harboring a KRASG12C mutation, met the primary endpoint of progression-free survival and the key secondary endpoint of overall response rate as assessed by Blinded Independent Central Review at final analysis for these endpoints. The study remains ongoing to assess the additional key secondary endpoint of overall survival.
Colorectal Cancer			February 2024			Announced the FDA acceptance of the sNDA for Krazati in combination with cetuximab for the treatment of patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer. The acceptance was based on the results of the Phase I/II KRYSTAL-1 trial. The FDA granted the application priority review and assigned a PDUFA goal date of June 21, 2024.

Product			Indication			Date			Developments

Opdivo			Urothelial Carcinoma			March 2024			Announced FDA approval of Opdivo, in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. The approval is based on results from the Phase III CheckMate -901 trial evaluating Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy, compared to cisplatin-gemcitabine alone, for patients with previously untreated unresectable or metastatic urothelial carcinoma.
NSCLC			February 2024			Announced FDA acceptance of the sBLA for neoadjuvant Opdivo for the perioperative treatment of resectable stage IIA to IIIB NSCLC. The FDA assigned a PDUFA goal date of October 8, 2024. In addition, the European Medicines Agency (EMA) validated the type II variation application for neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage IIA to IIIB NSCLC. Application validation confirms the submission is complete and begins the EMA’s centralized review procedure. The FDA’s sBLA acceptance and the EMA’s application validation are based on results from the Phase 3 CheckMate -77T trial.
Renal Cell Carcinoma			January 2024			Announced data from the Phase III CheckMate -67T trial, evaluating subcutaneous nivolumab co-formulated with Halozyme’s proprietary recombinant human hyaluronidase compared to intravenous Opdivo in patients with advanced or metastatic clear cell RCC who have received prior systemic therapy. Data demonstrated noninferiority for the co-primary endpoints of Cavgd28 (time-averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state) compared to intravenous Opdivo. In addition, subcutaneous nivolumab displayed non-inferior objective response rate as assessed by Blinded Independent Central Review versus intravenous Opdivo.
January 2024			Announced four-year follow-up results from the CheckMate -9ER trial evaluating Opdivo in combination with Cabometyx* (cabozantinib) vs. sunitinib in patients with previously untreated advanced or metastatic RCC continued to show superior progression-free survival and objective response rates in patients treated with Opdivo plus Cabometyx* over sunitinib, regardless of risk classification based on IMDC scores. Superior overall survival was also observed in patients treated with the combination.

Opdivo+Yervoy			Hepatocellular Carcinoma			March 2024			Announced that Phase III CheckMate -9DW trial evaluating Opdivo plus Yervoy as a first-line treatment for patients with advanced hepatocellular carcinoma who have not received a prior systemic therapy met its primary endpoint of improved overall survival compared to investigator’s choice of sorafenib or lenvatinib at a pre-specified interim analysis.
Colorectal Cancer			January 2024			Announced that the Phase III CheckMate -8HW trial evaluating Opdivo plus Yervoy compared to investigator’s choice of chemotherapy as a first-line treatment for patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer met the dual primary endpoint of progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) at a pre-specific interim analysis. The study is ongoing to assess the second dual primary endpoint of PFS per BICR in patients receiving Opdivo plus Yervoy compared to Opdivo alone across all lines of therapy, as well as secondary endpoints. In addition, data from the Phase III CheckMate -8HW trial showed that the combination of Opdivo plus Yervoy reduced the risk of disease progression or death by 79% versus chemotherapy as a first-line treatment for patients with microsatellite instability–high or mismatch repair deficient metastatic colorectal cancer (MSIH/dMMR mCRC) compared to chemotherapy.
Renal Cell Carcinoma			January 2024			Announced that eight-year data from the Phase III CheckMate -214 trial evaluating Opdivo plus Yervoy versus sunitinib continued to demonstrate long-term survival results, reducing the risk of death by 28% in patients with previously untreated advanced or metastatic RCC, regardless of IMDC risk group. Patients treated with Opdivo plus Yervoy maintained superior survival and more durable response benefits compared to those who received sunitinib in both patients with intermediate- and poor-risk prognostic factors and across all randomized patients.

Product			Indication			Date			Developments

Reblozyl			Myelodysplastic Syndromes			April 2024			Announced the EC expanded approval of Reblozyl to include the first-line treatment of transfusion-dependent anemia due to very low, low and intermediate-risk myelodysplastic syndromes. The approval covers all European Union member states and is based on the pivotal Phase III COMMANDS trial.
January 2024			Announced that Japan's Ministry of Health, Labour and Welfare granted manufacturing and marketing approval for Reblozyl for MDS-related anemia. The approval is based on the results of the global Phase III COMMANDS trial and the Phase III MEDALIST study, as well as a Japanese Phase II study (Study MDS-003) in red blood cell transfusion-independent low-risk MDS patients.

Zeposia			Multiple Sclerosis			March 2024			Announced that data from the Phase III DAYBREAK open-label extension trial demonstrated the long-term efficacy and safety profile of Zeposia in patients with relapsing forms of multiple sclerosis. In the DAYBREAK long-term extension study, treatment with Zeposia demonstrated a low annualized relapse rate of 0.098 and 67% of patients were relapse-free at six years. An analysis of DAYBREAK data showed nearly 97% of followed patients were relapse-free at 90 days post Zeposia discontinuation. Patients that did relapse showed no evidence of rebound effect.
Crohn's disease			March 2024			Following initial analysis of results from the first of two induction studies in the Phase III YELLOWSTONE trial evaluating Zeposia in adult patients with moderate-to-severe active Crohn’s disease, it was determined that the study did not meet its primary endpoint of clinical remission at Week 12. The safety profile of Zeposia in this study was consistent with that observed in previously reported trials.
Ulcerative Colitis			February 2024			Announced that Japan's Ministry of Health, Labour and Welfare has accepted the Japanese New Drug Application for Zeposia for the treatment of moderate-to-severe ulcerative colitis, based on results from the Japanese Phase II/III RPC01-3013 study.

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 three months ended March 31, 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.