U.S. Food and Drug Administration Approves Sotyktu , Oral Treatment for Adults with Moderate-to-Severe Plaque Psoriasis

Bristol Myers Squibb's Sotyktu , a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, is the only approved TYK2 inhibitor worldwide and the first innovation in oral treatment for moderate-to-severe plaque psoriasis in nearly 10 years

Pivotal Phase 3 POETYK PSO clinical trials demonstrated superior efficacy of once-daily Sotyktu over placebo and twice-daily Otezla ^® (apremilast) in improving skin clearance

Sotyktu has a well-demonstrated safety and tolerability profile based on the POETYK PSO clinical trials

Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Sotyktu ™ (deucravacitinib), a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. ^1,2 Sotyktu is not recommended for use in combination with other potent immunosuppressants.

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Product image. (Photo: Bristol Myers Squibb)

The approval is based on results from the pivotal Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials, which demonstrated superior efficacy of once-daily Sotyktu compared to placebo and twice-daily Otezla ^® (apremilast) in 1,684 patients aged 18 years and older with moderate-to-severe plaque psoriasis. ¹ The superior efficacy of Sotyktu compared to placebo and Otezla was demonstrated at both 16 and 24 weeks, and responses with Sotyktu persisted through 52 weeks. See below for more information.

" Sotyktu has the potential to become the new standard of care oral treatment for people with moderate-to-severe plaque psoriasis, given its profile in helping patients achieve clearer skin as demonstrated in the POETYK PSO clinical program," said April Armstrong, MD, MPH, clinical investigator in the POETYK PSO-1 trial and Associate Dean and Professor of Dermatology at the University of Southern California. "People living with moderate-to-severe plaque psoriasis face significant burdens, and Sotyktu is a welcome first-line systemic treatment option."

Psoriasis is a widely prevalent, chronic, systemic immune-mediated disease that affects approximately 7.5 million people in the U.S. ³ Up to 90 percent of patients with psoriasis have plaque psoriasis, which is characterized by distinct, round or oval plaques typically covered by silvery white scales. Nearly one-quarter of people with psoriasis, or around two million in the U.S., have cases that are considered moderate-to-severe. ³

"The approval of Sotyktu represents an exciting day for patients suffering from moderate-to-severe plaque psoriasis who are not satisfied with topical and conventional treatments. This is another extraordinary achievement for Bristol Myers Squibb, as we bring forward a new mechanism of action, the first oral treatment approved in nearly 10 years, and the first orally dosed once-daily treatment for moderate-to-severe plaque psoriasis," said Samit Hirawat, MD, Chief Medical Officer, Bristol Myers Squibb. "We believe Sotyktu is a breakthrough in the treatment of patients with this condition, and we're excited about its potential in other immune-mediated diseases."

In the POETYK PSO trials, at Week 16, the most common adverse reactions (≥1 percent and higher than placebo) in patients on Sotyktu were upper respiratory infections (19.2 percent), blood creatine phosphokinase increase (2.7 percent), herpes simplex (2.0 percent), mouth ulcers (1.9 percent), folliculitis (1.7 percent) and acne (1.4 percent). ¹ In addition, 2.4 percent of patients on Sotyktu , 3.8 percent of patients on placebo, and 5.2 percent of patients on Otezla experienced adverse reactions leading to discontinuation. ^1,4

"Despite the availability of therapies, many people living with plaque psoriasis in the United States are untreated or undertreated, ^5,6 " said Leah M. Howard, JD, President and CEO of the National Psoriasis Foundation. "The FDA approval of a new oral treatment is exciting news for the psoriasis community. We welcome this new treatment option."

Bristol Myers Squibb thanks the patients and investigators involved in the POETYK PSO clinical trial program. Sotyktu is expected to be available to patients in the U.S. in September 2022.

About POETYK PSO-1 and POETYK PSO-2

The pivotal Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials evaluated the safety and efficacy of Sotyktu (6 mg once daily) compared to placebo and Otezla ^® (apremilast) (30 mg twice daily) in patients with moderate-to-severe plaque psoriasis. Both were multi-national, multi-center, randomized, double-blind, placebo- and active comparator-controlled 52-week Phase 3 studies. POETYK PSO-2 included a randomized withdrawal and retreatment period after Week 24. In total, 664 patients were enrolled in POETYK PSO-1 and 1,020 patients were enrolled in POETYK PSO-2. All participants had moderate-to-severe plaque psoriasis and were candidates for phototherapy or systemic therapy. Patients had a body surface area involvement of ≥10 percent, a Psoriasis Area and Severity Index (PASI) score ≥12, and a static Physician's Global Assessment (sPGA) ≥3 (moderate or severe).

The co-primary endpoints of both POETYK PSO-1 and POETYK PSO-2 were the percentage of patients who achieved Psoriasis Area and Severity Index 75 and the percentage of patients who achieved static Physician's Global Assessment score of 0 or 1 at Week 16 versus placebo. Key secondary endpoints included the percentage of patients who achieved PASI 75, PASI 90 and sPGA 0/1 compared to Otezla at Week 16 and Week 24.

POETYK PSO-1 (n=664) Results at Week 16 and Week 24
Endpoint*	Time	Sotyktu 6 mg (n=330)	Placebo (n=166)	P-value vs. placebo	Otezla 30 mg (n=168)	P-value vs. Otezla
PASI 75* ^a	Week 16	58%*	13%*	P	35%	P
PASI 75* ^a	Week 24	69%	-	-	38%	P
PASI 90 ^b	Week 16	36%	4%	P	20%	P=0.0002
PASI 90 ^b	Week 24	42%	-	-	22%	P
sPGA 0/1* ^c	Week 16	54%*	7%*	P	32%	P
sPGA 0/1* ^c	Week 24	59%	-	-	31%	P
POETYK PSO-2 (n=1,020) Results at Week 16 and Week 24
Endpoint	Time	Sotyktu 6 mg (n=511)	Placebo (n=255)	P-value vs. placebo	Otezla 30 mg (n=254)	P-value vs. Otezla
PASI 75* ^a	Week 16*	53%*	9%*	P	40%	P=0.0004
PASI 75* ^a	Week 24	58%	-	-	38%	P
PASI 90 ^b	Week 16	27%	3%	P	18%	P=0.0046
PASI 90 ^b	Week 24	32%	-	-	20%	P=0.0002
sPGA 0/1* ^c	Week 16*	50%*	9%*	P	34%	P
sPGA 0/1* ^c	Week 24	49%	-	-	30%	P

*Co-primary endpoints for POETYK PSO-1 and POETYK PSO-2 were PASI 75 and sPGA 0/1 for Sotyktu vs. placebo at Week 16.
a. PASI 75 is defined as at least a 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) scores.
b. PASI 90 is defined as at least a 90% improvement from baseline in Psoriasis Area and Severity Index (PASI) scores.
c. sPGA 0/1 is defined as a static Physician's Global Assessment (sPGA) score of clear or almost clear.

Responses persisted through Week 52, as 82 percent (187/228) of patients who achieved PASI 75 with Sotyktu at Week 24 maintained their response at Week 52 in POETYK PSO-1. In POETYK PSO-2, 80 percent (119/148) of patients who continued on Sotyktu maintained PASI 75 response compared to 31 percent (47/150) of patients who were withdrawn from Sotyktu .

Through Week 16, infections occurred in 29 percent of patients treated with Sotyktu compared to 22 percent of those treated with placebo. The majority of infections were non-serious and mild to moderate in severity and did not lead to discontinuation of Sotyktu . Serious infections were reported in five patients receiving Sotyktu and two patients treated with placebo. Through Week 52, the most common serious infections reported were pneumonia and COVID-19. Malignancies (excluding non-melanoma skin cancer) were reported in three patients treated with Sotyktu .

About Psoriasis

Psoriasis is a widely prevalent, chronic, systemic immune-mediated disease that substantially impairs patients' physical health, quality of life and work productivity. ⁷ Psoriasis is a serious global problem, with at least 100 million people worldwide impacted by some form of the disease, ⁸ including approximately 7.5 million people in the U.S. ³ Nearly one-quarter of people with psoriasis have cases that are considered moderate-to-severe. ³ Up to 90 percent of patients with psoriasis have psoriasis vulgaris, or plaque psoriasis, ⁶ which is characterized by distinct round or oval plaques typically covered by silvery-white scales.

About Sotyktu ^TM

Sotyktu™ (deucravacitinib) is a selective, allosteric inhibitor of tyrosine kinase 2 (TYK2). TYK2 is a member of the Janus kinase (JAK) family. Sotyktu binds to the regulatory domain of TYK2, stabilizing an inhibitory interaction between the regulatory and the catalytic domains of the enzyme. This results in allosteric inhibition of receptor-mediated activation of TYK2 and its downstream activation of Signal Transducers and Activators of Transcription (STATs) as shown in cell-based assays. Janus kinases function as pairs of homo- or heterodimers in the JAK-STAT pathways. TYK2 pairs with JAK1 to mediate multiple cytokine pathways and also pairs with JAK2 to transmit signals as shown in cell-based assays. The precise mechanism linking inhibition of TYK2 enzyme to therapeutic effectiveness in the treatment of adults with moderate-to-severe plaque psoriasis is not currently known.

Sotyktu is under regulatory review by the European Medical Association and other health authorities around the world for the treatment of moderate-to-severe plaque psoriasis and by Japan's Ministry of Health, Labour and Welfare for the treatment of adults with moderate-to-severe plaque psoriasis, pustular psoriasis and erythrodermic psoriasis.

INDICATION

SOTYKTU™ (deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Limitations of Use:

SOTYKTU is not recommended for use in combination with other potent immunosuppressants.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

SOTYKTU is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in SOTYKTU.

WARNINGS AND PRECAUTIONS

Hypersensitivity: Hypersensitivity reactions such as angioedema have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue SOTYKTU.

Infections: SOTYKTU may increase the risk of infections. Serious infections have been reported in patients with psoriasis who received SOTYKTU. The most common serious infections reported with SOTYKTU included pneumonia and COVID-19. Avoid use of SOTYKTU in patients with an active or serious infection. Consider the risks and benefits of treatment prior to initiating SOTYKTU in patients:

with chronic or recurrent infection
who have been exposed to tuberculosis
with a history of a serious or an opportunistic infection
with underlying conditions that may predispose them to infection.

Closely monitor patients for the development of signs and symptoms of infection during and after treatment. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing, have appropriate antimicrobial therapy initiated and be closely monitored. Interrupt SOTYKTU if a patient develops a serious infection. Do not resume SOTYKTU until the infection resolves or is adequately treated.

Viral Reactivation

Herpes virus reactivation (e.g., herpes zoster, herpes simplex) was reported in clinical trials with SOTYKTU. Through Week 16, herpes simplex infections were reported in 17 patients (6.8 per 100 patient-years) treated with SOTYKTU, and 1 patient (0.8 per 100 patient-years) treated with placebo. Multidermatomal herpes zoster was reported in an immunocompetent patient. During PSO-1, PSO-2, and the open-label extension trial, the majority of patients who reported events of herpes zoster while receiving SOTYKTU were under 50 years of age. The impact of SOTYKTU on chronic viral hepatitis reactivation is unknown. Consider viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting and during therapy with SOTYKTU. If signs of reactivation occur, consult a hepatitis specialist. SOTYKTU is not recommended for use in patients with active hepatitis B or hepatitis C.

Tuberculosis (TB): In clinical trials, of 4 patients with latent TB who were treated with SOTYKTU and received appropriate TB prophylaxis, no patients developed active TB (during the mean follow-up of 34 weeks). One patient, who did not have latent TB, developed active TB after receiving 54 weeks of SOTYKTU. Evaluate patients for latent and active TB infection prior to initiating treatment with SOTYKTU. Do not administer SOTYKTU to patients with active TB. Initiate treatment of latent TB prior to administering SOTYKTU. Consider anti-TB therapy prior to initiation of SOTYKTU in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during treatment.

Malignancy including Lymphomas: Malignancies, including lymphomas, were observed in clinical trials with SOTYKTU. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with SOTYKTU, particularly in patients with a known malignancy (other than a successfully treated non-melanoma skin cancer) and patients who develop a malignancy when on treatment with SOTYKTU.

Rhabdomyolysis and Elevated CPK: Treatment with SOTYKTU was associated with an increased incidence of asymptomatic creatine phosphokinase (CPK) elevation and rhabdomyolysis compared to placebo.

Discontinue SOTYKTU if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Instruct patients to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.

Laboratory Abnormalities: Treatment with SOTYKTU was associated with increases in triglyceride levels. Periodically evaluate serum triglycerides according to clinical guidelines during treatment. SOTYKTU treatment was associated with an increase in the incidence of liver enzyme elevation compared to placebo. Evaluate liver enzymes at baseline and thereafter in patients with known or suspected liver disease according to routine management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt SOTYKTU until a diagnosis of liver injury is excluded.

Immunizations: Prior to initiating therapy with SOTYKTU, consider completion of all age-appropriate immunizations according to current immunization guidelines including prophylactic herpes zoster vaccination. Avoid use of live vaccines in patients treated with SOTYKTU. The response to live or non-live vaccines has not been evaluated.

Potential Risks Related to JAK Inhibition: It is not known whether tyrosine kinase 2 (TYK2) inhibition may be associated with the observed or potential adverse reactions of Janus Kinase (JAK) inhibition. In a large, randomized, postmarketing safety trial of a JAK inhibitor in rheumatoid arthritis (RA), patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. SOTYKTU is not approved for use in RA.

ADVERSE REACTIONS

Most common adverse reactions (≥1% of patients on SOTYKTU and more frequently than with placebo) include upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis and acne.

SPECIFIC POPULATIONS

Pregnancy: Available data from case reports on SOTYKTU use during pregnancy are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Report pregnancies to the Bristol-Myers Squibb Company's Adverse Event reporting line at 1-800-721-5072.

Lactation: There are no data on the presence of SOTYKTU in human milk, the effects on the breastfed infant, or the effects on milk production. SOTYKTU is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for SOTYKTU and any potential adverse effects on the breastfed infant from SOTYKTU or from the underlying maternal condition.

Hepatic Impairment: SOTYKTU is not recommended for use in patients with severe hepatic impairment.

SOTYKTU is available in 6 mg tablets.

Please see U.S. Full Prescribing Information , including Medication Guide , for SOTYKTU.

About Bristol Myers Squibb's Patient Access Support

Bristol Myers Squibb remains committed to providing assistance so that patients who need our medicines can access them and expedite time to therapy.

Bristol Myers Squibb offers various programs and resources to support access to therapies, including SOTYKTU, through our SOTYKTU 360 SUPPORT program. For additional information, call SOTYKTU 360 SUPPORT at 1-888-SOTYKTU (1-888-768-9588) 8 a.m. to 11 p.m. ET, Monday through Friday.

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 .

Otezla ^® (apremilast) is a registered trademark of Amgen Inc.

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, whether SOTYKTU™(deucravacitinib) will be commercially successful, any marketing approvals, if granted, may have significant limitations on their use, and that continued approval of SOTYKTU™ (deucravacitinib) may be contingent upon verification and description of clinical benefit in confirmatory trials. 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.

References

¹ SOTYKTU Prescribing Information. SOTYKTU U.S. Product Information. September 2022. Princeton, N.J.: Bristol-Myers Squibb Company.
² Chimalakonda A, Burke J, Cheng L, et al. Selectivity profile of the tyrosine kinase 2 inhibitor deucravacitinib compared with janus kinase 1/2/3 inhibitors. Dermatol Ther (Heidelb) 2021;11(5):1763–1776. doi: 10.1007/s13555-021-00596-8.
³ Armstrong AW, Mehta MD, Schupp CW, et al. Psoriasis prevalence in adults in the United States. JAMA Dermatol. Published online June 30, 2021. doi:10.1001/jamadermatol.2021.2007.
⁴ Armstrong A, Gooderham M, Warren RB, et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial, Journal of the American Academy of Dermatology (2022), doi: https://doi.org/10.1016/j.jaad.2022.07.002 .
⁵ Lebwohl M, Langley RG, Paul C, et al. Evolution of patient perceptions of psoriatic disease: results from the Understanding Psoriatic Disease Leveraging Insights for Treatment (UPLIFT) survey. Dermatol Ther (Heidelb). 2022;12(1):61-78. Doi: 10.1007/s13555-021-00635-4.
⁶ Menter A, Gottlieb A, Feldman SR, Van Voorhees AS et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol . 2008 May;58(5):826-50.
⁷ Armstrong AW, Schupp C, Wu J, Bebo B. Quality of life and work productivity impairment among psoriasis patients: findings from the National Psoriasis Foundation survey data 2003–2011. PloS One. 2012;7(12):e52935.
8 World Health Organization. Global report on psoriasis. 2016. Accessed May 12, 2022. https://apps.who.int/iris/bitstream/handle/10665/204417/9789241565189_eng.pdf.psoriasis?sequence=1

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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.

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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.

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.

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