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

Management’s discussion and analysis of results of operations and financial condition 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 continue to renew and diversify our portfolio through launching new medicines, advancing our early, mid and late-stage pipeline, and executing disciplined business development. Our focus is on discovering, developing and delivering transformational medicines for patients facing serious diseases in the following core therapeutic areas: (i) oncology with a priority in certain tumor types; (ii) hematology with opportunities to broaden our franchise and sustain a leadership position in multiple myeloma; (iii) immunology with priorities in psoriasis, lupus, RA, inflammatory bowel diseases and fibrotic lung diseases; (iv) cardiovascular disease; and (v) neuroscience with a focus on neurodegenerative disease. 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 are committed to the strategic allocation of resources and investing in areas that maximize value and drive sustainable growth. We remain committed to maintaining a strong investment grade credit rating and returning capital to shareholders. 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 2022 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 2023, we received approvals for initial and additional indications for the following marketed products in major markets (the U.S., EU and Japan), which further expanded our geographical reach in immunology, hematology and oncology including: (i) U.S. and EC approval of Opdivo expanding upon the existing adjuvant treatment for melanoma patients; (ii) FDA approval of Reblozyl in the first-line setting for the treatment of anemia in MDS and EC approval for an additional indication for anemia associated with non-transfusion-dependent beta thalassemia; (iii) approvals in Japan and by the EC of Opdivo in combination with chemotherapy for the neoadjuvant treatment of patients with resectable NSCLC; (iv) approval of Camzyos for the treatment of symptomatic obstructive HCM by the EC; (v) approval of Breyanzi for the second-line treatment of diffuse large B-cell lymphoma by the EC; and (vi) approval for Sotyktu for moderate-to-severe plaque psoriasis by the EC. We continue expanding our commercial CAR-T manufacturing network through the FDA approval of our Devens, MA facility in June 2023. In October 2023, we entered into a definitive merger agreement to acquire Mirati, a commercial stage targeted oncology company with a pipeline of commercial, clinical and pre-clinical stage oncology medicines and assets, including Krazati,* a best-in-class inhibitor of KRASG12C mutation, which was approved by the FDA as a second-line treatment for patients with NSCLC, and MRTX1719, a potential first-in-class MTA-cooperative PRMT5 inhibitor in Phase 1 development, among others*.*

Revenues decreased by 4% for the nine months ended September 30, 2023 primarily due to lower Revlimid sales driven by the previously disclosed generic erosion and increase in patients receiving free drug product for Revlimid, and to a lesser extent, Pomalyst, from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which BMS donates product, and foreign exchange impacts of 1% partially offset by higher sales in our New Product Portfolio and In-Line Products (primarily Opdivo). The $0.99 increase in GAAP EPS was primarily driven by the impact of certain specified items, including lower losses on equity investments and amortization of intangible assets, litigation and other settlement income and a deferred income tax benefit related to a non-U.S. tax ruling. After adjusting for specified items, non-GAAP EPS decreased $0.08 primarily as a result of lower revenues, partially offset by lower Acquired IPRD charges, net interest expense, effective income tax rate and weighted average shares outstanding.

			Three Months Ended September 30,												Nine Months Ended September 30,
Dollars in millions, except per share data			2023						2022						2023						2022
Total Revenues			$	10,966					$	11,218					$	33,529					$	34,753
Diluted earnings per share
GAAP			$	0.93					$	0.75					$	2.99					$	2.00
Non-GAAP			2.00						1.99						5.80						5.88

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. For example, some of the provisions of the IRA signed into law in August 2022, were as follows: (i) the government requires pharmaceutical manufacturers like BMS, under the threat of significant penalties, to sell certain innovative Medicare Part D and Part B medicines at government-set discounted prices, (ii) manufacturers are to pay an inflation-based rebate for Medicare Part B and Part D medicines, and (iii) Medicare Part D redesign. In addition, there were changes made to U.S. tax laws, including (i) a 15% minimum tax that generally applies to U.S. corporations, and a (ii) a non-deductible 1% excise tax provision on net stock repurchases, to be applied to repurchases beginning in 2023. Implementation of this legislation is expected to be carried out through upcoming actions by regulatory authorities, the outcome of which is uncertain. 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. See "Item 1. Financial Statements—Note 18. Legal Proceedings and Contingencies—Other Litigation" for further information. Furthermore, countries are expected to make changes to their tax laws and updates to international tax treaties to implement the agreement by the Organization for Economic Co-operation and Development 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 2022 Form 10-K.

Significant Product and Pipeline Approvals

The following is a summary of the significant approvals received in 2023 as of October 26, 2023:

Product			Date			Approval

Opdivo			October 2023			FDA approval of Opdivo for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stages IIB and IIC melanoma.

Reblozyl			August 2023			FDA approval of Reblozyl as first-line treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low- to intermediate-risk MDS who may also require red blood cell transfusions.

Opdivo			August 2023			EC approval of Opdivo for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stages IIB and IIC melanoma.

Opdivo			June 2023			EC approval of Opdivo in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable NSCLC at a high risk of recurrence in adult patients with tumor cell PD-L1 expression > 1%.

Camzyos			June 2023			EC approval of Camzyos for the treatment of symptomatic (New York Heart Association, class II-III) obstructive HCM in adult patients.

Breyanzi			May 2023			EC approval of Breyanzi for the treatment of adult patients with diffuse large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B, who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.

Opdivo			March 2023			Japan's Ministry of Health, Labour and Welfare approval of Opdivo plus chemotherapy for the neoadjuvant treatment of patients with resectable NSCLC.

Sotyktu			March 2023			EC approval of Sotyktu for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.

Reblozyl			March 2023			EC approval of Reblozyl for the treatment in adult patients of anemia associated with non-transfusion-dependent beta thalassemia.

Refer to "—Product and Pipeline Developments" for the developments in our marketed products and late-stage pipeline since the start of the third quarter of 2023.

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 millions			2023						2022						% Change						Foreign Exchange**(b)**						2023						2022						% Change						Foreign Exchange**(b)**
United States			$	7,628					$	7,941					(4)		%				—		%				$	23,552					$	23,903					(1)		%				—		%
International			3,153						3,062						3		%				1		%				9,462						10,216						(7)		%				(2)		%
Other(a)			185						215						(14)		%				N/A						515						634						(19)		%				N/A
Total			$	10,966					$	11,218					(2)		%				1		%				$	33,529					$	34,753					(4)		%				(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 decreased 4% during the third quarter of 2023 and 1% year-to-date, primarily due to lower Revlimid sales driven by the previously disclosed generic erosion and increase in patients receiving free drug product for Revlimid, and to a lesser extent, Pomalyst, from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which BMS donates product*,* partially offset by an increase in demand for our In-Line Products and New Product Portfolio*.* Average U.S. net selling prices decreased 1% year-to-date compared to the same period a year ago.

International

• International revenues increased 3% during the third quarter of 2023 primarily due to Opdivo and New Product Portfolio and foreign exchange, partially offset by lower average net selling prices.

• International revenues decreased 7% year-to-date primarily due to Revlimid and Eliquis generic erosion, lower average net selling prices and foreign exchange, partially offset by Opdivo and New Product Portfolio.

No single country outside the U.S. contributed more than 10% of total revenues during the nine months ended September 30, 2023 and 2022. 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 millions			2023						2022						% Change						2023						2022						% Change
Gross product sales			$	18,648					$	17,606					6		%				$	54,047					$	51,555					5		%
GTN adjustments
Charge-backs and cash discounts			(2,373)						(1,907)						24		%				(6,743)						(5,420)						24		%
Medicaid and Medicare rebates			(3,730)						(3,295)						13		%				(9,355)						(8,003)						17		%
Other rebates, returns, discounts and adjustments			(1,900)						(1,591)						19		%				(5,339)						(4,526)						18		%
Total GTN adjustments			(8,003)						(6,793)						18		%				(21,437)						(17,949)						19		%
Net product sales			$	10,645					$	10,813					(2)		%				$	32,610					$	33,606					(3)		%
GTN adjustments percentage			43		%				38		%				5		%				40		%				35		%				5		%
U.S.			49		%				43		%				6		%				45		%				40		%				5		%
Non-U.S.			20		%				18		%				2		%				20		%				17		%				3		%

Reductions to provisions for product sales made in prior periods resulting from changes in estimates were $18 million and $116 million for the three and nine months ended September 30, 2023 and $10 million and $207 million for the three and nine months ended September 30, 2022, 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 millions			2023						2022						% Change						2023						2022						% Change
In-Line Products
Eliquis			$	2,705					$	2,655					2		%				$	9,332					$	9,101					3		%
U.S.			1,799						1,729						4		%				6,693						6,068						10		%
Non-U.S.			906						926						(2)		%				2,639						3,033						(13)		%
Opdivo			2,275						2,047						11		%				6,622						6,033						10		%
U.S.			1,352						1,243						9		%				3,872						3,547						9		%
Non-U.S.			923						804						15		%				2,750						2,486						11		%
Pomalyst/Imnovid			872						886						(2)		%				2,551						2,620						(3)		%
U.S.			610						640						(5)		%				1,725						1,813						(5)		%
Non-U.S.			262						246						7		%				826						807						2		%
Orencia			925						883						5		%				2,616						2,551						3		%
U.S.			719						682						5		%				1,988						1,928						3		%
Non-U.S.			206						201						2		%				628						623						1		%
Sprycel			517						560						(8)		%				1,404						1,587						(12)		%
U.S.			406						402						1		%				1,029						1,079						(5)		%
Non-U.S.			111						158						(30)		%				375						508						(26)		%
Yervoy			579						523						11		%				1,672						1,563						7		%
U.S.			362						322						12		%				1,045						959						9		%
Non-U.S.			217						201						8		%				627						604						4		%
Mature and other products			476						514						(7)		%				1,415						1,563						(9)		%
U.S.			191						191						—		%				570						565						1		%
Non-U.S.			285						323						(12)		%				845						998						(15)		%
Total In-Line Products			8,349						8,068						3		%				25,612						25,018						2		%
U.S.			5,439						5,209						4		%				16,922						15,959						6		%
Non-U.S.			2,910						2,859						2		%				8,690						9,059						(4)		%

			Three Months Ended September 30,																		Nine Months Ended September 30,
Dollars in millions			2023						2022						% Change						2023						2022						% Change
New Product Portfolio
Reblozyl			248						190						31		%				688						518						33		%
U.S.			200						156						28		%				537						434						24		%
Non-U.S.			48						34						41		%				151						84						80		%
Abecma			93						107						(13)		%				372						263						41		%
U.S.			69						75						(8)		%				302						203						49		%
Non-U.S.			24						32						(25)		%				70						60						17		%
Opdualag			166						84						98		%				437						148						*
U.S.			162						84						93		%				430						148						*
Non-U.S.			4						—						N/A						7						—						N/A
Zeposia			123						69						78		%				301						171						76		%
U.S.			96						50						92		%				223						119						87		%
Non-U.S.			27						19						42		%				78						52						50		%
Breyanzi			92						44						*						263						127						*
U.S.			77						35						*						218						109						100		%
Non-U.S.			15						9						67		%				45						18						*
Onureg			43						32						34		%				121						87						39		%
U.S.			30						24						25		%				86						68						26		%
Non-U.S.			13						8						63		%				35						19						84		%
Inrebic			29						21						38		%				81						62						31		%
U.S.			19						17						12		%				55						52						6		%
Non-U.S.			10						4						*						26						10						*
Camzyos			68						5						*						143						8						*
U.S.			67						5						*						142						8						*
Non-U.S.			1						—						N/A						1						—						N/A
Sotyktu			66						1						*						107						1						*
U.S.			62						1						*						101						1						*
Non-U.S.			4						—						N/A						6						—						N/A
Total New Product Portfolio			928						553						68		%				2,513						1,385						81		%
U.S.			782						447						75		%				2,094						1,142						83		%
Non-U.S.			146						106						38		%				419						243						72		%
Total In-Line Products and New Product Portfolio			9,277						8,621						8		%				28,125						26,403						7		%
U.S.			6,221						5,656						10		%				19,016						17,101						11		%
Non-U.S.			3,056						2,965						3		%				9,109						9,302						(2)		%

			Three Months Ended September 30,																		Nine Months Ended September 30,
Dollars in millions			2023						2022						% Change						2023						2022						% Change
Recent LOE Products(a)
Revlimid			1,429						2,420						(41)		%				4,647						7,718						(40)		%
U.S.			1,226						2,170						(44)		%				4,004						6,338						(37)		%
Non-U.S.			203						250						(19)		%				643						1,380						(53)		%
Abraxane			260						177						47		%				757						632						20		%
U.S.			181						115						57		%				532						464						15		%
Non-U.S.			79						62						27		%				225						168						34		%
Total Recent LOE Products			1,689						2,597						(35)		%				5,404						8,350						(35)		%
U.S.			1,407						2,285						(38)		%				4,536						6,802						(33)		%
Non-U.S.			282						312						(10)		%				868						1,548						(44)		%
Total Revenues			$	10,966					$	11,218					(2)		%				$	33,529					$	34,753					(4)		%
U.S.			$	7,628					$	7,941					(4)		%				$	23,552					$	23,903					(1)		%
Non-U.S.			$	3,338					$	3,277					2		%				$	9,977					$	10,850					(8)		%

• Change in excess of 100%.

(a) Recent LOE Products includes products with significant decline in revenue from a prior reporting period as a result of a loss of exclusivity.

In-Line Products

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

• U.S. revenues increased 4% during the third quarter of 2023 and 10% year-to-date primarily due to higher demand, partially offset by lower average net selling prices, including higher GTN adjustments due to product mix in 2023. A majority of Eliquis patients enter the coverage gap during the third and fourth quarters, which is expected to result in lower revenues during the second half of the year.

• International revenues decreased 2% during the third quarter of 2023 and 13% year-to-date primarily due to lower average net selling price, generic erosion in the UK and Canada partially offset by foreign exchange impact of 4% in the third quarter. Generic erosion had a more significant impact in the first half of 2023. The decrease in international revenues year-to-date included foreign exchange impacts of 1%. Excluding foreign exchange impacts, revenues decreased by 6% and 12%, respectively.

• Following the May 2021 expiration of regulatory exclusivity for Eliquis in Europe and the court decision in the United Kingdom 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 and Sweden, 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.

Opdivo (nivolumab) — a fully human monoclonal antibody that binds to the PD-1 on T and natural killer T cells that has been approved for several anti-cancer indications including bladder, blood, CRC, head and neck, RCC, hepatocellular carcinoma, 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 increased 9% during both the third quarter of 2023 and year-to-date primarily due to higher demand across multiple indications and to a lesser extent higher average net selling prices. The higher demand was related to the following indications: the Opdivo+Yervoy combinations for NSCLC, various gastric, esophageal and bladder cancers.

• International revenues increased 15% during the third quarter of 2023 and 11% year-to-date due to higher demand as a result of additional indication launches and core indications and to a lesser extent lower average net selling prices. The year-to-date revenue increase was partially offset by foreign exchange impact of 3%. Excluding foreign exchange impacts, revenues increased 15% and 14%, respectively.

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 decreased 5% during both the third quarter of 2023 and year-to-date due to an increase in the number 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, partially offset by higher average net selling prices.

• International revenues increased 7% during the third quarter of 2023 and 2% year-to-date primarily due to higher demand and foreign exchange impacts of 3% partially offset by lower average net selling prices in the third quarter. The year-to-date revenues increase was partially offset by lower average net selling prices and foreign exchange impacts of 2%. Excluding foreign exchange impacts, revenues increased by 4% in both periods.

Orencia (abatacept) — a fusion protein indicated for adult patients with moderate to severe active RA and psoriatic arthritis and is also indicated for reducing signs and symptoms in certain pediatric patients with moderately to severely active polyarticular juvenile idiopathic arthritis.

• U.S. revenues increased 5% during the third quarter of 2023 and 3% year-to-date primarily due to higher demand. Year-to-date was also impacted by lower average net selling prices.

• International revenues increased 2% during the third quarter of 2023 and 1% year-to-date due to higher demand and in the third quarter, foreign exchange impacts of 1%. The year-to-date revenue increase was also partially offset by foreign exchange impacts of 3%. Excluding foreign exchange impacts, revenues increased by 1% and 4%, respectively.

• 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.

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 increased 1% during the third quarter of 2023 due to increased demand partially offset by lower average net selling prices.

• U.S. revenues decreased 5% year-to-date due to lower average selling price driven by unfavorable prior period GTN adjustments.

• International revenues decreased 30% during the third quarter of 2023 and 26% year-to-date primarily due to lower demand as a result of generic erosion, lower average net selling price and foreign exchange impacts of 1% and 3%, respectively. Excluding foreign exchange impacts, revenues decreased by 29% and 23%, respectively.

• 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.

Yervoy (ipilimumab) — a monoclonal antibody for the treatment of patients with unresectable or metastatic melanoma. The Opdivo+Yervoy regimen also is approved in multiple markets for the treatment of NSCLC, melanoma, MPM, RCC, CRC and esophageal cancer.

• U.S. revenues increased 12% during the third quarter of 2023 and 9% year-to-date primarily due to higher demand and average net selling prices.

• International revenues increased 8% during the third quarter of 2023 and 4% year-to-date primarily due to higher demand as a result of additional indication launches and core indications and foreign exchange impacts of 2% during the third quarter of 2023. The year-to-date increase was partially offset by lower average net selling price and foreign exchange impacts of 3%. Excluding foreign exchange impacts, revenues increased by 6% and 7%, respectively.

Mature and other products — includes all other products, including those which have lost exclusivity in major markets, OTC products, royalty revenue and mature products.

• International revenues decreased 12% during the third quarter of 2023 and 15% year-to-date primarily due to continued generic erosion, lower average net selling prices and foreign exchange impacts of 1% and 2%, respectively. Excluding foreign exchange impacts, revenues decreased by 11% and 13%, respectively.

New Product Portfolio

Reblozyl (luspatercept-aamt) — an erythroid maturation agent indicated for the treatment of anemia in i) adult patients with transfusion dependent and non-transfusion dependent beta thalassemia who require regular red blood cell transfusions, ii) adult patients with very low- to intermediate-risk MDS who have ring sideroblasts and require red blood cell transfusions, as well as iii) adult patients without previous erythropoiesis stimulating agent use (ESA-naïve) with very low- to intermediate-risk MDS who may require regular red blood cell transfusions, regardless of ring sideroblast status. Reblozyl was launched in November 2019.

• U.S. revenues increased 28% during the third quarter of 2023 and 24% year-to-date primarily due to higher demand.

Abecma (idecabtagene vicleucel) — is a B-cell maturation antigen-directed ("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. Abecma was launched in May 2021.

• U.S. revenues decreased 8% during the third quarter of 2023 resulting from a planned facility maintenance and lower demand due to increased competition in BCMA targeted therapies, partially offset by higher average net selling prices.

• U.S. revenues increased 49% year-to-date primarily due to higher demand enabled by additional manufacturing capacity.

Opdualag (nivolumab and relatlimab-rmbw) — a combination of nivolumab, a PD-1 blocking antibody, and relatlimab, a lymphocyte activation gene-3 blocking antibody, indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. Opdualag was launched in March 2022.

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. Zeposia was launched in June 2020.

Breyanzi (lisocabtagene maraleucel) — is a CD19-directed genetically modified autologous CAR-T cell therapy indicated for the treatment of adult patients with certain types of relapsed or refractory large B-cell lymphoma after one or more lines of systemic therapy. Breyanzi was launched in April 2021.

Onureg (azacitidine) — an oral hypomethylating agent that incorporates into DNA and RNA, indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy. Onureg was launched in September 2020.

Inrebic (fedratinib) — an oral kinase inhibitor indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis. Inrebic was launched in August 2019.

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.

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.

Recent LOE Products

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.

• U.S. revenues decreased 44% during the third quarter of 2023 and 37% year-to-date primarily due to generic erosion and an increase in the number 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, and to a lesser extent lower average net selling prices.

• International revenues decreased 19% during the third quarter of 2023 and 53% year-to-date primarily due to generic erosion across several European countries and foreign exchange impacts of 1%. The year-to-date decrease was also impacted by lower average net selling prices. Excluding foreign exchange impacts, revenues decreased by 18% and 52%, respectively.

• In the U.S., certain third parties have been 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, generic lenalidomide products have entered the market. Global revenues for Revlimid are expected to decline to approximately $6.0 billion in 2023.

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 increased 57% during the third quarter of 2023 and 15% year-to-date primarily due to higher branded sales resulting from lower authorized generic sales.

Estimated End-User Demand

Pursuant to the SEC Consent Order described under "— SEC Consent Order" in our 2022 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, 2023, for our U.S. distribution channels, and June 30, 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 86% of total gross sales of U.S. products during the nine months ended September 30, 2023. Factors that may influence our estimates include generic competition, 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.

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.

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.

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, 2023 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 September 30,																		Nine Months Ended September 30,
Dollars in millions			2023						2022						% Change						2023						2022						% Change
Cost of products sold(a)			$	2,506					$	2,353					7		%				$	7,948					$	7,544					5		%
Marketing, selling and administrative			2,003						1,930						4		%				5,699						5,548						3		%
Research and development			2,242						2,418						(7)		%				6,821						6,999						(3)		%
Acquired IPRD			80						30						*						313						763						(59)		%
Amortization of acquired intangible assets			2,256						2,418						(7)		%				6,769						7,252						(7)		%
Other (income)/expense, net			(258)						(140)						84		%				(787)						793						*
Total Expenses			$	8,829					$	9,009					(2)		%				$	26,763					$	28,899					(7)		%

• In excess of +/- 100%.

(a) Excludes amortization of acquired intangible assets.

Cost of Products Sold

Cost of products sold increased by $153 million in the third quarter of 2023 and $404 million year-to-date primarily due to lower hedging settlement gains ($143 million in the quarter and $147 million year-to-date) and higher royalty and profit sharing ($28 million in the quarter and $270 million year-to-date). Year-to-date also included the offsetting impacts of higher CAR-T cell therapy inventory charges and the elimination of the Puerto Rico excise tax ($164 million).

Marketing, Selling and Administrative

Marketing, selling and administrative expense increased by $73 million in the third quarter of 2023 primarily driven by higher advertising and promotion costs to support new product launches, a lease impairment in 2023 ($65 million) and timing of charitable giving ($90 million), partially offset by the cash settlement of Turning Point unvested stock awards ($73 million) in 2022.

Marketing, selling and administrative expense increased by $151 million year-to-date primarily due to higher advertising and promotion costs to support new product launches, and consulting costs supporting corporate initiatives, a lease impairment in 2023 ($65 million), partially offset by timing of charitable giving ($60 million) and cash settlement of Turning Point unvested stock awards ($73 million).

Research and Development

Research and development expense decreased by $176 million in the third quarter of 2023 and $178 million year-to-date, primarily due to lower clinical grants and supplies in 2023 and the cash settlement of Turning Point unvested stock awards ($80 million) in 2022. Year-to-date also included the impacts of the unwinding of inventory purchase price adjustments for clinical use ($130 million) in 2022, 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 September 30,												Nine Months Ended September 30,
Dollars in millions			2023						2022						2023						2022
Mavacamten royalty extinguishment			$	—					$	—					$	—					$	295
Dragonfly milestone			—						—						—						175
Prothena opt-in license fee			—						—						55						—
Immatics upfront license fee			—						—						15						150
Evotec designation and opt-in license fees			—						—						90						—
BridgeBio upfront license fee			—						—						—						90
Zenas upfront license fee			50						—						50						—
Other			30						30						103						53
Acquired IPRD charges			$	80					$	30					$	313					$	763

Amortization of Acquired Intangible Assets

Amortization of acquired intangible assets decreased by $162 million in the third quarter of 2023 and $483 million year-to-date primarily due to Abraxane marketed product right being fully amortized in the fourth quarter of 2022.

Other (Income)/Expense, Net

Other (income)/expense, net changed by $118 million in the third quarter of 2023 and $1.6 billion year-to-date primarily litigation and other settlements, equity investments and other items discussed below.

			Three Months Ended September 30,												Nine Months Ended September 30,
Dollars in millions			2023						2022						2023						2022
Interest expense			$	280					$	299					$	850					$	938
Royalty and licensing income			(365)						(374)						(1,068)						(967)
Royalty income - divestitures			(217)						(205)						(623)						(597)
Equity investment losses			—						14						213						966
Integration expenses			54						114						180						343
Loss on debt redemption			—						—						—						266
Divestiture gains			—						—						—						(211)
Litigation and other settlements			(61)						44						(393)						32
Investment income			(107)						(52)						(304)						(89)
Provision for restructuring			141						17						321						60
Other			17						3						37						52
Other (income)/expense, net			$	(258)					$	(140)					$	(787)					$	793

• Interest expense decreased in the third quarter of 2023 and year-to-date compared to 2022 due to additional debt maturities. Refer to "Item 1. Financial Statements and Supplementary Data—Note 10. Financing Arrangements" for further information.

• Royalties increased in the third quarter of 2023 and year-to-date primarily due to higher Keytruda* and diabetes business divestiture royalties. Refer to "Item 1. Financial Statements and Supplementary Data—Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements" for further information.

• Equity investments generated lower losses in the third quarter of 2023 and year-to-date compared to 2022 primarily driven by fair value adjustments for investments that have readily determinable fair value. Refer to "Item 1. Financial Statements and Supplementary Data—Note 9. Financial Instruments and Fair Value Measurements" for more information.

• Integration expenses decreased in the third quarter of 2023 and year-to-date primarily due to lower consulting fees to implement Celgene integration initiatives related to processes and systems.

• Loss on debt redemption resulted from the early redemption of long-term debt during the nine months ended September 30, 2022, as further discussed in "Item 1. Financial Statements and Supplementary Data—Note 10. Financing Arrangements".

• Divestiture gains resulted from the divestiture of certain mature product rights during the first quarter of 2022.

• Litigation and other settlements include $384 million of income related to the AZ settlement, partially offset by $322 million expense recorded in connection with the BeiGene settlement in 2023. In addition, year-to-date 2023 included $400 million of income related to the Nimbus' TYK2 program change of control provision incurred during the second quarter. Refer to "Item 1. Financial Statements and Supplementary Data—Note 5. Other (Income)/Expense, Net" for further information.

• Investment income increased during the third quarter of 2023 and year-to-date primarily due to higher interest rates.

• Provision for restructuring includes exit and other costs primarily related to certain restructuring activities including a new plan in 2023 discussed further in "Item 1. Financial Statements and Supplementary Data—Note 6. Restructuring".

Income Taxes

			Three Months Ended September 30,															Nine Months Ended September 30,
Dollars in millions			2023						2022									2023						2022
Earnings before income taxes			$	2,137					$	2,209								$	6,766					$	5,854
Income tax provision			203						601									488						1,534
Effective tax rate			9.5		%				27.2		%							7.2		%				26.2		%
Impact of specified items			(2.1)		%				10.3		%							(7.5)		%				9.6		%
Effective tax rate excluding specified items			11.6		%				16.9		%							14.7		%				16.6		%

Provision for income taxes in interim periods are determined based on the estimated annual effective tax rates and the tax impact of discrete items that are reflected immediately. The reduction in the effective tax rate during the third quarter of 2023 was primarily due to recently issued Section 174 guidance regarding deductibility of certain non-U.S. research and development expenses. The revised guidance resulted in a reduction of previously estimated income taxes attributed to 2022, which was reflected in the current quarter as well as a reduction in the estimated annual effective rates for 2023. Previously estimated income taxes for 2022 were reduced by approximately $240 million upon finalization of the U.S. Federal tax return primarily due to the aforementioned revised Section 174 guidance that was issued in the third quarter of 2023.

In addition, the effective tax rate during the first nine months of 2023 was 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 audits, partially offset by the impact of changes in the Puerto Rico tax decree that eliminated a previously creditable excise tax. Additional changes to the effective tax rate may occur in future periods due to various reasons, including changes to the estimated pretax earnings mix and tax reserves and revised interpretations or changes to the relevant tax code.

The changes in the non-GAAP effective tax rate were due to the changes in the aforementioned changes to Section 174 guidance, Puerto Rico tax decree, jurisdictional earnings mix and the tax reserve releases in the first quarter of 2023.

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 Therapeutics 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. 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 26, 2023 and are incorporated herein by reference.

Non-GAAP information is intended to portray the results of our baseline performance, supplement or enhance management, 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 consolidated 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 millions			2023						2022						2023						2022
Inventory purchase price accounting adjustments			$	—					$	86					$	84					$	240
Site exit and other costs			16						—						53						43
Cost of products sold			16						86						137						283
Employee compensation charges			—						73						—						73
Site exit and other costs			65						—						85						6
Marketing, selling and administrative			65						73						85						79
IPRD impairments			60						58						80						98
Priority review voucher			—						—						95						—
Inventory purchase price accounting adjustments			—						22						—						130
Employee compensation charges			—						80						—						80
Site exit and other costs			4						—						10						—
Research and development			64						160						185						308
Amortization of acquired intangible assets			2,256						2,418						6,769						7,252
Interest expense(a)			(12)						(18)						(39)						(66)
Equity investment (income)/losses			(2)						12						206						962
Integration expenses			54						114						180						343
Loss on debt redemption			—						—						—						266
Divestiture gains			—						—						—						(211)
Litigation and other settlements			(62)						36						(397)						(4)
Provision for restructuring			141						17						321						60
Other			28						28						23						70
Other (income)/expense, net			147						189						294						1,420
Increase to pretax income			2,548						2,926						7,470						9,342
Income taxes on items above			(340)						(268)						(944)						(987)
Income taxes attributed to non-U.S. tax ruling			—						—						(656)						—
Income taxes			(340)						(268)						(1,600)						(987)
Increase to net earnings			$	2,208					$	2,658					$	5,870					$	8,355

(a) 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 data			2023						2022						2023						2022
Net earnings attributable to BMS
GAAP			$	1,928					$	1,606					$	6,263					$	4,305
Specified items			2,208						2,658						5,870						8,355
Non-GAAP			$	4,136					$	4,264					$	12,133					$	12,660
Weighted-average common shares outstanding – diluted			2,064						2,148						2,093						2,154
Diluted earnings per share attributable to BMS
GAAP			$	0.93					$	0.75					$	2.99					$	2.00
Specified items			1.07						1.24						2.81						3.88
Non-GAAP			$	2.00					$	1.99					$	5.80					$	5.88

FINANCIAL POSITION, LIQUIDITY AND CAPITAL RESOURCES

Our net debt position was as follows:

Dollars in Millions			September 30, 2023						December 31, 2022
Cash and cash equivalents			$	7,514					$	9,123
Marketable debt securities – current			171						130
Marketable debt securities – non-current			325						—
Total cash, cash equivalents and marketable debt securities			8,010						9,253
Short-term debt obligations			(5,467)						(4,264)
Long-term debt			(32,137)						(35,056)
Net debt position			$	(29,594)					$	(30,067)

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 nine months ended September 30, 2023, our net debt position decreased by $473 million primarily driven by $9.6 billion of cash provided by operations partially offset by $8.7 billion of dividend payments and common stock repurchases.

During the first nine months ended September 30, 2023, $1.9 billion of debt matured and was repaid including $750 million 2.750% Notes, $890 million 3.250% Notes and $239 million 7.150% Notes.

During the nine months ended September 30, 2023 we repurchased an aggregate $5.2 billion of common stock. Refer to "Item 1. Financial Statements and Supplementary Data—Note 16. Equity" for further information.

Dividend payments were $3.6 billion during the nine months ended September 30, 2023. Dividend paid per common share was $0.57 during each of the first, second and third quarters of 2023. The decision to authorize dividends is made on a quarterly basis by our Board of Directors.

Annual capital expenditures are expected to be approximately $1.1 billion and $1.4 billion in 2023 and 2024, respectively. 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 September 30, 2023 and December 31, 2022.

Under our commercial paper program, we may issue a maximum of $5.0 billion unsecured notes that have maturities of not more than 366 days from the date of issuance. There were no commercial paper borrowings outstanding as of September 30, 2023.

Cash Flows

The following is a discussion of cash flow activities:

			Nine Months Ended September 30,
Dollars in millions			2023						2022
Cash flow provided by/(used in):
Operating activities			$	9,608					$	9,760
Investing activities			(949)						(2,275)
Financing activities			(10,383)						(13,716)

Operating Activities

The $152 million decrease in cash provided by operating activities compared to 2022 was primarily due to lower collections of $700 million (net of rebates and discounts) partially offset by lower non-refundable advance payments for research and development services ($500 million).

Investing Activities

The $1.3 billion decrease in cash used in investing activities compared to 2022 was primarily due to the acquisition of Turning Point ($3.2 billion net of cash acquired) in 2022 partially offset by changes in the amount of marketable debt securities held ($2.0 billion).

Financing Activities

The $3.3 billion decrease in cash used in financing activities compared to 2022 was primarily due to lower net debt borrowings ($3.8 billion), lower share repurchases ($430 million) partially offset by lower proceeds from stock option exercises ($803 million).

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 2023:

Product			Indication			Date			Developments

Opdivo			Bladder			October 2023			Announced results from the Phase III CheckMate -901 trial in which Opdivo in combination with cisplatin-based chemotherapy followed by Opdivo monotherapy demonstrated statistically significant and clinically meaningful improvements in the primary efficacy endpoints of overall survival and progression-free survival as assessed by Blinded Independent Central Review compared to standard-of-care cisplatin-based chemotherapy as a first-line treatment for patients with unresectable or metastatic urothelial carcinoma who are cisplatin-eligible. With a median follow up of 33 months, treatment with Opdivo in combination with cisplatin-based chemotherapy reduced risk of death by 22%; no new safety signals were identified.
Melanoma			October 2023			Announced FDA approval of Opdivo for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stages IIB and IIC melanoma. The approval is based on the Phase III CheckMate -76K trial.
August 2023			Announced EC approval of Opdivo for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stages IIB and IIC melanoma. The approval is based on results from the Phase III CheckMate -76K trial.
NSCLC			October 2023			Announced follow-up results from the Phase III CheckMate -816 trial, demonstrating sustained event-free survival and promising overall survival trends with three cycles of Opdivo in combination with platinum-based chemotherapy for the neoadjuvant treatment of patients with resectable NSCLC, regardless of PD-L1 expression levels. Neoadjuvant Opdivo with chemotherapy also showed improvements in pathologic complete response and major pathologic response over chemotherapy alone in PD-L1>1% and <1% patient populations. The safety profile of the *Opdivo-*based regimen was consistent across all PD-L1 subgroups.
October 2023			Announced that the first disclosure of data from the Phase III CheckMate -77T trial evaluating perioperative regimen of neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo in patients with resectable stage IIA to IIIB NSCLC showed statistically significant and clinically meaning improvement in the primary efficacy endpoint of event-free survival as assessed by Blinded Independent Central Review compared to neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo. Neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo reduced the risk of disease recurrence, progression or death by 42% in patients with resectable non-small cell lung cancer.

Product			Indication			Date			Developments

Opdivo			Prostate Cancer			July 2023			Announced that results from the Phase III CheckMate -7DX trial evaluating Opdivo in combination with docetaxel in patients with advanced or metastatic castration-resistant prostate cancer did not meet the primary endpoints of radiographic progressive free survival at final analysis, nor overall survival at an interim analysis. No safety concerns were reported. Based on the recommendation from the data monitoring committee, the Company has decided to discontinue the study.
RCC			October 2023			Announced that the Phase III CheckMate -67T noninferiority trial evaluating the subcutaneous formulation of Opdivo co-formulated with Halozyme Therapeutics’ proprietary recombinant human hyaluronidase (rHPuH20) ("subcutaneous nivolumab") compared to intravenous (IV) Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy met its co-primary pharmacokinetics endpoints and key secondary endpoint. Subcutaneous nivolumab demonstrated noninferiority of Cavgd28 (time-averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state) compared to IV Opdivo, the study’s co-primary endpoints. Additionally, subcutaneous nivolumab showed a noninferior objective response rate as assessed by Blinded Independent Central Review vs. IV Opdivo, a key secondary endpoint. The safety profile of subcutaneous nivolumab was consistent with the IV formulation.

Opdivo+Yervoy			NSCLC			September 2023			Announced six-year results from Part 1 of the Phase III CheckMate -227 trial demonstrating long-term, durable survival benefits of Opdivo plus Yervoy compared to chemotherapy in the first-line treatment of patients with metastatic NSCLC, regardless of PD-L1 expression levels.

Reblozyl			MDS			August 2023			Announced FDA approval of Reblozyl as first-line treatment of anemia in adults with lower-risk Myelodysplastic Syndromes (MDS) who may require transfusions. This expanded indication to the first-line setting is based on interim results from the Phase III COMMANDS trial, expanding approved population to ESA-naïve patients, regardless of ring sideroblast status.

Zeposia			Multiple Sclerosis			October 2023			Announced data from the Phase III DAYBREAK and RADIANCE trials showing that after eight years of follow-up, 76% of patients treated with Zeposia for relapsing multiple sclerosis were free of six-month confirmed disability progression. Findings also demonstrated treatment with Zeposia resulted in low rates of progression independent relapse activity and relapse-associated worsening, key drivers of disease progression and permanent disability in multiple sclerosis. Also announced that first interim readout from the Phase IIIb ENLIGHTEN trial showing clinically meaningful improvement in cognitive functioning compared to baseline after one year of Zeposia treatment in almost half of patients with early relapsing multiple sclerosis.

Camzyos			Obstructive HCM			August 2023			Announced long-term follow-up results from the Phase III VALOR-HCM LTE trial demonstrating consistent impact of oral treatment for severely symptomatic obstructive HCM patients by showing that nearly 9 out of 10 patients treated with Camzyos have continued in the trial without septal reduction therapy at either 40 or 56 weeks of treatment. Also announced long-term follow-up results from the Phase III EXPLORER-LTE trial showing sustained improvements in left ventricular outflow tract obstruction, symptoms and NT-proBNP levels in patients with symptomatic obstructive HCM. No new safety signals were observed.

Sotyktu			Plaque Psoriasis			October 2023			Announced results from the POETYK PSO LTE trial of Sotyktu treatment in adult patients with moderate-to-severe plaque psoriasis. Clinical response rates were maintained with continuous treatment with modified nonresponder imputation responses of 73.2% for Psoriasis Area and Severity Index (PASI) 75 with 3 years of continuous Sotyktu treatment. Sotyktu had a consistent safety profile with no increases in adverse events or serious adverse events and no new safety signals.

repotrectinib			NSCLC			October 2023			Announced the submission of the Japan NDA to the Pharmaceuticals and Medical Devices Agency for repotrectinib, a next-generation ROS1/TRK tyrosine kinase inhibitor, for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. The application is based on data from the registrational Phase I/II TRIDENT-1 trial.
August 2023			Announced updated results from the registrational Phase I/II TRIDENT-1 trial demonstrating that repotrectinib, a next-generation ROS1/TRK tyrosine kinase inhibitor, continued to show high response rates and durable responses, including robust intracranial responses, in patients with ROS1-positive locally advanced or metastatic NSCLC. Based on prior results from the TRIDENT-1 trial, the FDA accepted the NDA for repotrectinib granting Priority Review and assigned a PDUFA goal date of November 27, 2023.

Product			Indication			Date			Developments

LPA1			Progressive Pulmonary Fibrosis			October 2023			Announced that the FDA has granted Breakthrough Therapy Designation for BMS-986278, a potential first-in-class, oral, lysophosphatidic acid receptor 1 (LPA1) antagonist, for the treatment of progressive pulmonary fibrosis (PPF). The Breakthrough Therapy Designation is based on results from the global, randomized Phase II study that assessed the safety and efficacy of BMS-986278 treatment versus placebo in people living with idiopathic pulmonary fibrosis (IPF) and PPF. Stable background use of antifibrotics in the IPF cohort and/or select immunosuppressives in the PPF cohort were allowed.

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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 2022 Form 10-K. There have been no material changes to our critical accounting policies during the nine months ended September 30, 2023. 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, our ability to complete the acquisition of Mirati, and in relation to our ability to realize the projected benefits of our acquisitions of Celgene, MyoKardia, Turning Point and Mirati, the impact of the COVID-19 pandemic 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 2022 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.