Bristol Myers Squibb Announces New Prescription Drug User Fee Act Goal Date for Reblozyl® Supplemental Biologics License Application

Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has extended the review of the supplemental biologics license application (sBLA) for Reblozyl ^® (luspatercept-aamt) for the treatment of anemia in adults with non-transfusion-dependent (NTD) beta thalassemia to June 27, 2022. Reblozyl is being developed and commercialized through a global collaboration with Merck & Co., Inc., known as MSD outside the United States and Canada, following Merck's acquisition of Acceleron Pharma, Inc. in November 2021.

A written response to an information request was determined by the FDA to constitute a major amendment; therefore the Agency has extended the Prescription Drug User Fee Act (PDUFA) goal date by three months to provide time for a full review of the submission. The sBLA was based on safety and efficacy results from the pivotal Phase 2 BEYOND study evaluating Reblozyl plus best supportive care in adults with NTD beta thalassemia. There is an application (Type II variation) also under review by the European Medicines Agency.

Reblozyl , a first-in-class therapeutic option, is currently approved in the United States and European Union to address transfusion-dependent anemia-associated beta thalassemia and lower-risk myelodysplastic syndromes failing an erythropoietin-stimulating agent (ESA) and requiring red blood cell transfusions.

About Reblozyl ^®

Reblozyl, a first-in-class therapeutic option, promotes late-stage red blood cell maturation in animal models. ¹ Reblozyl is being developed and commercialized through a global collaboration with Merck following Merck's acquisition of Acceleron Pharma, Inc. in November 2021. Reblozyl is currently approved in the U.S. for the treatment of:

anemia in adult patients with beta thalassemia who require regular red blood cell transfusions, and
anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndrome with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).

Reblozyl is not indicated for use as a substitute for red blood cell transfusions in patients who require immediate correction of anemia.

Important Safety Information

WARNINGS AND PRECAUTIONS

Thrombosis/Thromboembolism

In adult patients with beta thalassemia, thromboembolic events (TEE) were reported in 8/223 (3.6%) REBLOZYL-treated patients. TEEs included deep vein thrombosis, pulmonary embolus, portal vein thrombosis, and ischemic stroke. Patients with known risk factors for thromboembolism (splenectomy or concomitant use of hormone replacement therapy) may be at further increased risk of thromboembolic conditions. Consider thromboprophylaxis in patients at increased risk of TEE. Monitor patients for signs and symptoms of thromboembolic events and institute treatment promptly.

Hypertension

Hypertension was reported in 10.7% (61/571) of REBLOZYL-treated patients. Across clinical studies, the incidence of Grade 3 to 4 hypertension ranged from 1.8% to 8.6%. In patients with beta thalassemia with normal baseline blood pressure, 13 (6.2%) patients developed systolic blood pressure (SBP) ≥130 mm Hg and 33 (16.6%) patients developed diastolic blood pressure (DBP) ≥80 mm Hg. In adult patients with MDS with normal baseline blood pressure, 26 (29.9%) patients developed SBP ≥130 mm Hg and 23 (16.4%) patients developed DBP ≥80 mm Hg. Monitor blood pressure prior to each administration. Manage new or exacerbations of preexisting hypertension using anti-hypertensive agents.

Embryo-Fetal Toxicity

REBLOZYL may cause fetal harm when administered to a pregnant woman. REBLOZYL caused increased post-implantation loss, decreased litter size, and an increased incidence of skeletal variations in pregnant rat and rabbit studies. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 3 months after the final dose.

ADVERSE REACTIONS

Beta Thalassemia

Serious adverse reactions occurred in 3.6% of patients on REBLOZYL. Serious adverse reactions occurring in 1% of patients included cerebrovascular accident and deep vein thrombosis. A fatal adverse reaction occurred in 1 patient treated with REBLOZYL who died due to an unconfirmed case of acute myeloid leukemia (AML).
Most common adverse reactions (at least 10% for REBLOZYL and 1% more than placebo) were headache (26% vs 24%), bone pain (20% vs 8%), arthralgia (19% vs 12%), fatigue (14% vs 13%), cough (14% vs 11%), abdominal pain (14% vs 12%), diarrhea (12% vs 10%) and dizziness (11% vs 5%).

Myelodysplastic Syndromes

Grade > 3 (≥2%) adverse reactions included fatigue, hypertension, syncope and musculoskeletal pain. A fatal adverse reaction occurred in 5 (2.1%) patients.
The most common (≥10%) adverse reactions included fatigue, musculoskeletal pain, dizziness, diarrhea, nausea, hypersensitivity reactions, hypertension, headache, upper respiratory tract infection, bronchitis, and urinary tract infection.

LACTATION

It is not known whether REBLOZYL is excreted into human milk or absorbed systemically after ingestion by a nursing infant. REBLOZYL was detected in milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because many drugs are excreted in human milk, and because of the unknown effects of REBLOZYL in infants, a decision should be made whether to discontinue nursing or to discontinue treatment. Because of the potential for serious adverse reactions in the breastfed child, breastfeeding is not recommended during treatment and for 3 months after the last dose .

Please see full Prescribing Information for REBLOZYL.

Bristol Myers Squibb: Creating a Better Future for People with Cancer

Bristol Myers Squibb is inspired by a single vision — transforming people's lives through science. The goal of the company's cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient's life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn , Twitter , YouTube , Facebook and Instagram .

Juno Therapeutics, Inc. is a wholly owned subsidiary of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

Bristol Myers Squibb's Cautionary Statement Regarding Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on 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, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, the possibility that Reblozyl (luspatercept-aamt) may not receive regulatory approval for the additional indication described in this release in the currently anticipated timeline or at all, that any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether such product candidate for such additional indication described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb's business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2021, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

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References:

Galanello R, Origa R. Beta thalassemia. Orphanet Journal of Rare Diseases. 2010;5(11). Available at: https://ojrd.biomedcentral.com/articles/10.1186/1750-1172-5-11 . Accessed March 2022.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220324006050/en/

BMS Contacts:

Media Inquiries:
media@bms.com

Investors:
investor.relations@bms.com

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Corporate Employers Accused of Increasing Risk Of Pension Shortfalls in Violation of Employee Retirement Income Security Act of 1974

Lawsuits have been filed alleging that a number of large corporate employers have offloaded billions of dollars in pension obligations to Athene Annuity and Life Company andor Athene Annuity & Life Assurance Company of New York, subsidiaries of Athene Holding Ltd. (collectively, "Athene") in violation of ERISA. In addition to AT&T Inc. (NYSE: T), Lockheed Martin Corporation (NYSE: LMT), and Alcoa Corporation (NYSE: AA), against which lawsuits have already been filed, according to SEC filings andor Athene's public statements, Bristol-Myers Squibb Company (NYSE: BMY), Armstrong World Industries, Inc. (NYSE: AWI), ATI, Inc. (NYSE: ATI), Weyerhaeuser Company (NYSE: WY), and General Electric (NYSE: GE) have offloaded pension obligations to Athene.

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Bristol Myers Squibb Announces Leadership Transition Plan

Giovanni Caforio, MD, Bristol Myers Squibb Chairman and CEO, to Retire as CEO, Effective November 1, 2023; Will Continue as Executive Chairman of the Board

Christopher Boerner, PhD, EVP, Chief Commercialization Officer, Appointed EVP, Chief Operating Officer, Effective Immediately; to Succeed Giovanni Caforio, MD, as CEO, Effective November 1, 2023

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Bristol Myers Squibb Strengthens Cell Therapy Capabilities by Adding New U.S. Manufacturing Facility for Viral Vector Production

Libertyville, Illinois facility bolsters long-term viral vector supply with multi-product, in-house viral vector production capabilities

Bristol Myers Squibb (NYSE: BMY) today announced expansion of its global cell therapy manufacturing network to enable in-house viral vector production through a U.S.-based manufacturing facility and its operations in Libertyville, Illinois, following the company's execution of an agreement with Novartis. The facility and its operations have capabilities to produce viral vector for both of Bristol Myers Squibb's CAR T cell therapies. This development advances the company's long-term ambitions in cell therapy.

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Divesture of Non-US Assets for ~US$9.5M (~A$13.7M) Allowing for Payoff of A$8.2M Debt Facility while Funding Expansion of US Business

Hydration solutions company The Hydration Pharmaceuticals Company Limited (ASX: HPC) (“Hydralyte North America” or “the Company”) is pleased to announce that it has entered into an Intellectual Property Sales Agreement (the ‘Agreement’) with Prestige Consumer Healthcare Inc. and associated subsidiaries (together, ‘Prestige’). Pursuant to the Agreement and associated arrangements, the Company will assign and transfer the exclusive right to sell Hydralyte products, and associated intellectual property rights, to Prestige in all relevant jurisdictions other than the United States of America.¹

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Cardiex Announces Publication of Breakthrough Study Validating Noninvasive Fingertip Photoplethysmography for Central Aortic Pressure Waveform Analysis

- Cardiex Limited (ASX: CDX), a global health technology company focused on cardiovascular diagnostics and arterial health solutions, today announced the publication of a peer-reviewed study validating its innovative method for measuring central aortic pressure—an important indicator of heart health—using a noninvasive fingertip sensor. The study, co-authored by Cardiex's team, was published in the respected journal Pulse.

The study, titled "Validation of Noninvasive Derivation of the Central Aortic Pressure Waveform from Fingertip Photoplethysmography Using a Novel Selective Transfer Function Method," demonstrates that Cardiex's technology can accurately capture key cardiovascular data from a simple fingertip sensor. The method leverages photoplethysmography (PPG)—an optical technique widely used in wearables such as fitness trackers and smartwatches—offering a powerful and accessible tool for advanced heart health monitoring.

Key findings include:

Strong correlation between fingertip sensor measurements and traditional methods, with heart health indicators showing excellent alignment.
The fingertip sensor offers a user-friendly, noninvasive way to measure central aortic pressure parameters without calibration, making heart health monitoring more accessible and comfortable.
Twenty clinically relevant parameters were captured from the converted PPG waveforms, including central systolic blood pressure, central diastolic blood pressure, central pulse pressure, central augmentation pressure, central augmentation index, subendocardial viability, and pulse pressure amplification, amongst others.

Relevance in the Wearable Health Market:

The use of PPG technology in this study is especially significant as the wearable market continues to expand, with consumers seeking more advanced health insights without the need for frequent calibration. Cardiex's innovation aligns with this trend offering consumers the ability to track clinical grade biomarkers in real-time. These biomarkers have applications in various healthcare fields, including cognitive, renal, maternal, metabolic health, and heart failure management. The technology's ease of use and capacity for continuous monitoring place Cardiex at the forefront of the growing wearable health sector, which increasingly prioritizes deeper and more accurate health data.

"This study is a significant validation of Cardiex's technology and its ability to deliver critical heart health insights in a simpler, more convenient way," said Craig Cooper , CEO of Cardiex. "Our PPG-based fingertip technology has the potential to transform heart health monitoring, offering a more accessible option for both patients and healthcare providers. This breakthrough also opens up exciting opportunities for integration into the wearable health tech market, where continuous and noninvasive monitoring is becoming the gold standard."

The study confirms that Cardiex's PPG-based solution can provide valuable cardiovascular data in a comfortable, portable format, paving the way for broader adoption in both medical and consumer-grade wearables.

The full study is now available online in the journal Pulse DOI: 10.1159/000540666.

View original content to download multimedia: https://www.prnewswire.com/news-releases/cardiex-announces-publication-of-breakthrough-study-validating-noninvasive-fingertip-photoplethysmography-ppg-for-central-aortic-pressure-waveform-analysis-302259185.html

SOURCE Cardiex Limited

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	First Quarter

$ amounts in millions, except per share amounts	2023		2022		Change		Change Excl. F/X**
Total Revenues	$	11,337	$	11,648	(3	)%	(1)%
Earnings per share - GAAP*		1.07		0.59	81	%	N/A
Earnings per share - Non-GAAP*		2.05		1.96	5	%	N/A

* GAAP and non-GAAP earnings per share include the net impact of Acquired IPRD charges and licensing income of ($0.01) in 2023 compared to ($0.10) per share in 2022. ** See "Use of Non-GAAP Financial Information".

($ amounts in millions)	Quarter Ended March 31, 2023			% Change from Quarter Ended March 31, 2022			% Change from Quarter Ended March 31, 2022 (Excl. F/X) **
	U.S. ^(c)	Int'l	WW(d)	U.S. ^(c)	Int'l	WW(d)	Int'l	WW(d)
In-Line Products
Eliquis	$2,554	$869	$3,423	19%	(18)%	7%	(13)%	8%
Opdivo	1,290	912	2,202	17%	11%	15%	18%	17%
Pomalyst/Imnovid	545	287	832	(2)%	7%	1%	12%	2%
Orencia	562	202	764	(5)%	1%	(4)%	10%	(1)%
Sprycel	295	134	429	(3)%	(25)%	(11)%	(19)%	(9)%
Yervoy	314	194	508	1%	(5)%	(1)%	3%	2%
Mature and other products ^(a)	182	285	467	1%	(20)%	(13)%	(16)%	(10)%
Total In-Line Products	5,742	2,883	8,625	11%	(7)%	4%	(1)%	6%
New Product Portfolio
Reblozyl	158	48	206	18%	*	32%	*	33%
Abecma	118	29	147	*	*	*	*	*
Opdualag	116	1	117	*	N/A	*	N/A	*
Zeposia	52	26	78	*	73%	*	80%	*
Breyanzi	58	13	71	41%	*	61%	*	66%
Onureg	25	9	34	32%	*	48%	*	52%
Inrebic	17	8	25	13%	*	39%	*	39%
Camzyos	29	—	29	N/A	N/A	N/A	N/A	N/A
Sotyktu	15	1	16	N/A	N/A	N/A	N/A	N/A
Total New Product Portfolio	588	135	723	*	*	*	*	*
Total In-Line and New Product
Portfolio	6,330	3,018	9,348	15%	(4)%	8%	2%	10%
Recent LOE Products ^(b)
Revlimid	1,541	209	1,750	(24)%	(72)%	(37)%	(71)%	(37)%
Abraxane	162	77	239	(6)%	88%	12%	*	14%
Total Recent LOE Products	1,703	286	1,989	(23)%	(64)%	(34)%	(62)%	(33)%

Total Revenues	$8,033	$3,304	$11,337	4%	(16)%	(3)%	(11)%	(1)%

*		In excess of +100%
**		See "Use of Non-GAAP Financial Information".
(a)		Includes over-the-counter (OTC) products, royalty revenue and mature products.
(b)		Recent LOE Products includes products with significant expected decline in revenue from a prior reporting period as a result of a loss of exclusivity.
(c)		Includes Puerto Rico.
(d)		Worldwide (WW) includes International (Int'l) and U.S.

Category	Asset	Milestone
Regulatory	Camzyos ^® (mavacamten)	The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Camzyos for the treatment of symptomatic New York Heart Association class II-III obstructive hypertrophic cardiomyopathy (HCM) in adult patients. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP opinion. The positive opinion is based upon efficacy and safety results from two Phase 3 trials, EXPLORER- HCM and VALOR-HCM.
Clinical & Research	milvexian	The company, in collaboration with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, launched the Phase 3 Librexia program studying milvexian, an investigational oral factor XIa inhibitor (antithrombotic).The Librexia program will provide important data across three indication-seeking studies: Librexia STROKE for antiplatelet therapy for stroke prevention in acute ischemic stroke or high-risk transient ischemic stroke, Librexia ACS in addition to antiplatelet therapy for event reduction in acute coronary syndromes and Librexia AF which compares milvexian to apixaban in the prevention of stroke in patients with atrial fibrillation.

Category	Asset	Milestone
Regulatory	Opdivo ^® (nivolumab)	The U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics License Application (sBLA) for Opdivo as a monotherapy in the adjuvant setting for the treatment of patients with completely resected stage IIB or IIC melanoma. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of October 13, 2023. In addition, the EMA validated the Type II Variation Marketing Authorization Application for Opdivo as a monotherapy in the adjuvant setting for the treatment of patients with completely resected stage IIB or IIC melanoma. The EMA's validation confirms the submission is complete and begins the start of the EMA's centralized review process. The submissions were based on results from the Phase 3 CheckMate-76K clinical trial.
Clinical & Research	Opdivo	Three-year follow-up results from Phase 3 CheckMate -816 trial demonstrated sustained clinical benefits with three cycles of Opdivo in combination with platinum-based chemotherapy for the neoadjuvant treatment of patients with resectable NSCLC. While overall survival (OS) remained immature at this analysis, there was a continued encouraging trend in OS favoring neoadjuvant Opdivo with chemotherapy over chemotherapy alone.
		Three-year follow-up results from Phase 3 CheckMate -274 trial demonstrated significant sustained clinical benefits with Opdivo for the adjuvant treatment of patients with surgically resected, high-risk muscle-invasive urothelial carcinoma.
		Three-year follow-up results from Phase 3 CheckMate -9ER trial demonstrated sustained survival and response rate benefits with the combination of Opdivo and Exelixis Inc.'s CABOMETYX (cabozantinib) versus sunitinib in the first-line treatment of advanced renal cell carcinoma.

	U.S. GAAP		Non-GAAP ²
	February (Prior)	April (Revised)	February (Prior)	April (Affirmed)
Total Revenues *(as reported)*	~2% increase	No change	~2% increase	No change
Total Revenues *(excl. F/X)*	~2% increase	No change	~2% increase	No change
*Revlimid*	~$6.5 billion	No change	~$6.5 billion	No change
Gross Margin %	~77%	No change	~77%	No change
Operating Expenses ¹	Mid single-digit decline	No change	Low single-digit decline	No change
Tax Rate	~22%	~21%	~17%	No change
Diluted EPS	$4.03-$4.33	$4.10-$4.40	$7.95-$8.25	No change
¹ Operating Expenses = MS&A and R&D, excluding Acquired IPRD and Amortization of acquired intangible assets. ² See "Use of Non-GAAP Financial Information."

Bristol-Myers Squibb COMPANY CONSOLIDATED STATEMENTS OF EARNINGS FOR THE THREE MONTHS ENDED MARCH 31, 2023 AND 2022 (Unaudited, dollars and shares in millions except per share data)

	March 31,
		2023			2022
Net product sales	$	11,048		$	11,308
Alliance and other revenues		289			340
Total Revenues		11,337			11,648
Cost of products sold ^(a)		2,566			2,471
Marketing, selling and administrative		1,762			1,831
Research and development		2,321			2,260
Acquired IPRD		75			333
Amortization of acquired intangible assets		2,256			2,417
Other (income)/expense, net		(413	)		649
Total Expenses		8,567			9,961
Earnings Before Income Taxes		2,770			1,687
Provision for Income Taxes		503			404
Net Earnings		2,267			1,283
Noncontrolling Interest		5			5
Net Earnings Attributable to BMS	$	2,262		$	1,278
Weighted-Average Common Shares Outstanding:
Basic		2,099			2,146
Diluted		2,113			2,164

Earnings per Common Share:
Basic	$	1.08		$	0.60
Diluted		1.07			0.59
Other (income)/expense, net
Interest expense ^(b)	$	288		$	326
Royalty and licensing income		(363	)		(306	)
Royalty income - divestitures		(188	)		(171	)
Equity investment losses		155			644
Integration expenses		67			105
Loss on debt redemption		—			275
Divestiture gains		—			(211	)
Litigation and other settlements		(325	)		(37	)
Investment income		(102	)		(10	)
Provision for restructuring		67			23
Other		(12	)		11
Other (income)/expense, net	$	(413	)	$	649

(a)		Excludes amortization of acquired intangible assets.
(b)		Includes amortization of purchase price adjustments to Celgene debt.

Bristol-Myers Squibb COMPANY PRODUCT REVENUES FOR THE THREE MONTHS ENDED MARCH 31, 2023 AND 2022 (Unaudited, dollars in millions)

													Change vs. 2022
	2023						2022						GAAP			Excl. F/X**
	U.S. ^(c)		Int'l		WW (d)		U.S. ^(c)		Int'l		WW (d)		U.S. ^(c)	Int'l	WW (d)	U.S. ^(c)	Int'l	WW (d)
In-Line Products
Eliquis	$	2,554	$	869	$	3,423	$	2,147	$	1,064	$	3,211	19%	(18)%	7%	19%	(13)%	8%
Opdivo		1,290		912		2,202		1,099		824		1,923	17%	11%	15%	17%	18%	17%
Pomalyst/Imnovid		545		287		832		557		269		826	(2)%	7%	1%	(2)%	12%	2%
Orencia		562		202		764		592		200		792	(5)%	1%	(4)%	(5)%	10%	(1)%
Sprycel		295		134		429		305		178		483	(3)%	(25)%	(11)%	(3)%	(19)%	(9)%
Yervoy		314		194		508		311		204		515	1%	(5)%	(1)%	1%	3%	2%
Mature and other
brands ^(a)		182		285		467		180		357		537	1%	(20)%	(13)%	1%	(16)%	(10)%
Total In-Line Products		5,742		2,883		8,625		5,191		3,096		8,287	11%	(7)%	4%	11%	(1)%	6%
New Product Portfolio
Reblozyl		158		48		206		134		22		156	18%	*	32%	18%	*	33%
Abecma		118		29		147		56		11		67	*	*	*	*	*	*
Opdualag		116		1		117		6		—		6	*	N/A	*	*	N/A	*
Zeposia		52		26		78		21		15		36	*	73%	*	*	80%	*
Breyanzi		58		13		71		41		3		44	41%	*	61%	41%	*	66%
Onureg		25		9		34		19		4		23	32%	*	48%	32%	*	52%
Inrebic		17		8		25		15		3		18	13%	*	39%	13%	*	39%
Camzyos		29		—		29		—		—		—	N/A	N/A	N/A	N/A	N/A	N/A
Sotyktu		15		1		16		—		—		—	N/A	N/A	N/A	N/A	N/A	N/A
Total New Product Portfolio		588		135		723		292		58		350	*	*	*	*	*	*
Total In-Line and New Product Portfolio		6,330		3,018		9,348		5,483		3,154		8,637	15%	(4)%	8%	15%	2%	10%
Recent LOE Products ^(b)
Revlimid		1,541		209		1,750		2,038		759		2,797	(24)%	(72)%	(37)%	(24)%	(71)%	(37)%
Abraxane		162		77		239		173		41		214	(6)%	88%	12%	(6)%	*	14%
Total Recent LOE Products		1,703		286		1,989		2,211		800		3,011	(23)%	(64)%	(34)%	(23)%	(62)%	(33)%

Total Revenues	$	8,033	$	3,304	$	11,337	$	7,694	$	3,954	$	11,648	4%	(16)%	(3)%	4%	(11)%	(1)%

Bristol-Myers Squibb COMPANY INTERNATIONAL AND WORLDWIDE REVENUES FOREIGN EXCHANGE IMPACT (%) FOR THE THREE MONTHS ENDED MARCH 31, 2023 (Unaudited)

	International			WW (c)
	Change %	Favorable/ (Unfavorable) F/X %	Change % Excl. F/X	Change %	Favorable/ (Unfavorable) F/X %	Change % Excl. F/X**
In-Line Products
Eliquis	(18)%	(5)%	(13)%	7%	(1)%	8%
Opdivo	11%	(7)%	18%	15%	(2)%	17%
Pomalyst/Imnovid	7%	(5)%	12%	1%	(1)%	2%
Orencia	1%	(9)%	10%	(4)%	(3)%	(1)%
Sprycel	(25)%	(6)%	(19)%	(11)%	(2)%	(9)%
Yervoy	(5)	(8)%	3%	(1)%	(3)%	2%
Mature and other products ^(a)	(20)%	(4)%	(16)%	(13)%	(3)%	(10)%
Total In-Line Products	(7)%	(6)%	(1)%	4%	(2)%	6%
New Product Portfolio
Reblozyl	*	*	*	32%	(1)%	33%
Abecma	*	*	*	*	*	*
Opdualag	N/A	N/A	N/A	*	*	*
Zeposia	73%	(7)%	80%	*	*	*
Breyanzi	*	*	*	61%	(5)%	66%
Onureg	*	*	*	48%	(4)%	52%
Inrebic	*	*	*	39%	—	39%
Camzyos	N/A	N/A	N/A	N/A	N/A	N/A
Sotyktu	N/A	N/A	N/A	N/A	N/A	N/A
Total New Product Portfolio	*	*	*	*	*	*
Total In-Line Products and New
Product Portfolio	(4)%	(6)%	2%	8%	(2)%	10%
Recent LOE Products ^(b)
Revlimid	(72)%	(1)%	(71)%	(37)%	—	(37)%
Abraxane	88%	(14)%	*	12%	(2)%	14%
Total Recent LOE Products	(64)%	(2)%	(62)%	(34)%	(1)%	(33)%
Total	(16)%	(5)%	(11)%	(3)%	(2)%	(1)%

*		In excess of +/- 100%.
**		See "Use of Non-GAAP Financial Information".
(a)		Includes over-the-counter (OTC) products, royalty revenue and other mature products.
(b)		Recent LOE products include products with significant expected decline in revenue from a prior reporting period as a result of a loss of exclusivity.
(c)		Worldwide (WW) includes International (Int'l) and U.S.

Bristol-Myers Squibb COMPANY SPECIFIED ITEMS FOR THE THREE MONTHS ENDED MARCH 31, 2023 AND 2022 (Unaudited, dollars in millions)

	March 31,
	2023				2022
Inventory purchase price accounting adjustments	$	53		$	52
Site exit and other costs		1			—
Cost of products sold		54			52
Site exit and other costs		—			2
Marketing, selling and administrative		—			2
IPRD impairments		20			40
Inventory purchase price accounting adjustments		—			87
Priority review voucher		95			—
Research and development		115			127
Amortization of acquired intangible assets		2,256			2,417
Interest expense ^(a)		(14	)		(27	)
Equity investment losses/(income)		150			643
Integration expenses		67			105
Loss on debt redemption		—			275
Divestiture losses/(gains)		—			(211	)
Litigation and other settlements		(335	)		(40	)
Provision for restructuring		67			23
Other		(5	)		—
Other (income)/expense, net		(70	)		768

Increase to pretax income		2,355			3,366
Income taxes on items above		(293	)		(398	)
Increase to net earnings	$	2,062		$	2,968

Bristol-Myers Squibb COMPANY RECONCILIATION OF CERTAIN GAAP LINE ITEMS TO CERTAIN NON-GAAP LINE ITEMS FOR THE THREE MONTHS ENDED MARCH 31, 2023 AND 2022 (Unaudited, dollars and shares in millions except per share data)

	Three Months Ended March 31, 2023
	GAAP			Specified Items ^(a)			Non-GAAP
Gross profit	$	8,771		$	54		$	8,825
Marketing, selling and administrative		1,762			—			1,762
Research and development		2,321			(115	)		2,206
Amortization of acquired intangible assets		2,256			(2,256	)		—
Other (income)/expense, net		(413	)		70			(343	)
Earnings before income taxes		2,770			2,355			5,125
Provision for income taxes		503			293			796
Net earnings attributable to BMS used for diluted EPS calculation	$	2,262		$	2,062		$	4,324
Weighted-average common shares outstanding - diluted		2,113			2,113			2,113
Diluted earnings per share	$	1.07		$	0.98		$	2.05
Effective tax rate		18.2	%		(2.7	)%		15.5	%

	Three Months Ended March 31, 2022
	GAAP			Specified Items ^(a)			Non-GAAP
Gross profit	$	9,177		$	52		$	9,229
Marketing, selling and administrative		1,831			(2	)		1,829
Research and development		2,260			(127	)		2,133
Amortization of acquired intangible assets		2,417			(2,417	)		—
Other (income)/expense, net		649			(768	)		(119	)
Earnings before income taxes		1,687			3,366			5,053
Provision for income taxes		404			398			802
Net earnings attributable to BMS used for diluted EPS calculation	$	1,278		$	2,968		$	4,246
Weighted-average common shares outstanding - diluted		2,164			2,164			2,164
Diluted earnings per share	$	0.59		$	1.37		$	1.96
Effective tax rate		23.9	%		(8.0	)%		15.9	%

*		Foreign exchange impacts were derived 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.
**		See "Use of Non-GAAP Financial Information".
(a)		Refer to the Specified Items schedule above for further details.
(b)		Represents gross profit as a percentage of Revenues.

Category	Asset	Milestone
Regulatory	Sotyktu ™ (deucrava- citinib)	The EC approved Sotyktu, a first-in-class, oral, selective tyrosine kinase 2 inhibitor, for the treatment of adults with moderate-to- severe plaque psoriasis who are candidates for systemic therapy, representing a new way of treating this chronic immune-mediated disease. The approval was based on results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials. Additional data from the POETYK PSO long-term extension trial (LTE) also supported approval.

Bristol-Myers Squibb COMPANY NET DEBT CALCULATION AS OF MARCH 31, 2023 AND DECEMBER 31, 2022 (Unaudited, dollars in millions)

	March 31, 2023			December 31, 2022
Cash and cash equivalents	$	8,995		$	9,123
Marketable debt securities - current		274			130
Cash, cash equivalents and marketable debt securities		9,269			9,253
Short-term debt obligations		(2,752	)		(4,264	)
Long-term debt		(35,078	)		(35,056	)
Net debt position	$	(28,561	)	$	(30,067	)

Bristol-Myers Squibb COMPANY 2023 FULL YEAR PROJECTED DILUTED EPS FROM OPERATIONS EXCLUDING PROJECTED SPECIFIED ITEMS

		Full Year 2023
		Pre-tax		Tax		After-tax
Projected Diluted Earnings Attributable to Shareholders per Common Share - GAAP ^(a)		$4.10 to $4.40
Projected Specified Items:
Purchase price accounting adjustments ^(a)		4.27		0.54		3.73
Acquisition, restructuring and integration expenses ^(b)		0.17		0.03		0.14
Equity investment losses		0.07		0.01		0.06
Priority review voucher		0.04		0.01		0.03
Intangible asset impairment		0.01		—		0.01
Litigation and other settlements		(0.16	)	(0.04	)	(0.12	)
Total		4.40		0.55		3.85
Projected Diluted Earnings Attributable to Shareholders per Common Share - Non- GAAP ^(a)	$7.95 to $8.25

(a)		Includes amortization of acquired intangible assets, unwind of inventory fair value adjustments and amortization of fair value adjustments of debt assumed from Celgene.
(b)		Includes acquisition, restructuring and integration expenses recognized in Other (income)/expense, net.

The following table summarizes the company's 2023 financial guidance:
Line item	GAAP	Non-GAAP
Total reported revenues	~ 2% increase	~ 2% increase
Total revenues Ex-Fx ^(c)	~ 2% increase	~ 2% increase
Revlimid	~$6.5 billion	~$6.5 billion
Gross margin %	~ 77%	~ 77%
Operating expenses ^(d)	Mid single-digit decline	Low single-digit decline
Effective tax rate	~ 21%	~ 17%

(c)		Ex-FX excludes the impact of foreign exchange calculated by converting our current-period local currency financial results using the prior period average currency rates and comparing these adjusted amounts to our prior-period results.
(d)		Operating expenses consist of Marketing, selling and administrative expenses and Research and development expenses, excluding Acquired IPRD expenses.

Bristol Myers Squibb Announces New Prescription Drug User Fee Act Goal Date for Reblozyl® Supplemental Biologics License Application

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