U.S. Food and Drug Administration Approves Opdivo® with Chemotherapy as Neoadjuvant Treatment for Certain Adult Patients with Resectable Non-Small Cell Lung Cancer

Approval marks the first-and-only immunotherapy-based treatment for use before surgery for non-small cell lung cancer ¹

In the Phase 3 CheckMate -816 trial, Opdivo plus platinum-doublet chemotherapy significantly improved event-free survival and pathologic complete response compared to platinum-doublet chemotherapy alone ¹

Opdivo- based combinations now approved in both metastatic and earlier stages of non-small cell lung cancer

Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo ^® (nivolumab) 360 mg (injection for intravenous use) in combination with platinum-doublet chemotherapy every three weeks for three cycles for adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC) in the neoadjuvant setting. ¹ Opdivo plus chemotherapy is approved regardless of PD-L1 status. ¹ The approval is based on the CheckMate -816 trial, the first positive Phase 3 trial of an immunotherapy-based combination used before surgery for resectable NSCLC. The primary endpoints included event-free survival (EFS) and pathologic complete response (pCR), which were evaluated using independent blinded review, and an additional efficacy outcome measure was overall survival (OS). ¹ The study compared Opdivo plus platinum-doublet chemotherapy (n=179) to platinum-doublet chemotherapy alone (n=179). ¹

In the trial, when given before surgery, Opdivo plus chemotherapy showed a statistically significant improvement in EFS with a 37% reduction in the risk of progression, recurrence or death (Hazard Ratio [HR] 0.63; 95% Confidence Interval [CI]: 0.45 to 0.87; P =0.0052) compared to chemotherapy alone. ¹ Opdivo plus chemotherapy showed a median EFS of 31.6 months (95% CI: 30.2 to Not Reached [NR]) compared to 20.8 months for patients treated with chemotherapy alone (95% CI: 14.0 to 26.7). ¹ Additionally, 24% of patients treated with Opdivo plus chemotherapy achieved pCR (95% CI: 18.0 to 31.0), compared to 2.2% of patients treated with chemotherapy alone (95% CI: 0.6 to 5.6; estimated treatment difference 21.6; 95% CI: 15.1 to 28.2; P 1 A prespecified interim analysis for OS resulted in a HR of 0.57 (95% CI: 0.38 to 0.87), which did not cross the boundary for statistical significance. ¹

"Given the rates of disease recurrence in patients with resectable NSCLC, additional treatment options are needed that can be given before surgery to help improve the chance of successful surgical treatment and support the goal of reducing the risk of cancer returning," said Mark Awad, MD, PhD, CheckMate -816 study investigator and clinical director of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute. ^2,3 "The approval of nivolumab with platinum-doublet chemotherapy marks a turning point in how we treat resectable NSCLC and it enables us to use immunotherapy and chemotherapy as neoadjuvant treatment for patients before surgery. Today's announcement reinforces the need to increase the rates of NSCLC screening and early detection, and for patients to discuss treatment options with their providers." ¹

Opdivo is associated with the following Warnings & Precautions: severe and fatal immune-mediated adverse reactions including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, dermatologic adverse reactions, nephritis with renal dysfunction, other immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when Opdivo is added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials. ¹ Please see Important Safety Information below.

"At Bristol Myers Squibb, we are leading innovative science in the use of immunotherapy in earlier stages of cancer and are committed to bringing these options to patients," said Adam Lenkowsky, senior vice president and general manager, U.S. Cardiovascular, Immunology and Oncology at Bristol Myers Squibb. "Today's approval builds on that commitment and expands the role of Opdivo -based treatment in NSCLC, the most common form of lung cancer, so patients may benefit earlier in the course of their disease." ^1,4

This application was approved under the FDA's Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible. ⁵ The review was also conducted under the FDA's Project Orbis initiative, which enabled concurrent review by the health authorities in Australia, Canada and the United Kingdom, where the application remains under review. The EFS data from the Phase 3 CheckMate -816 trial will be presented at the American Association for Cancer Research Annual Meeting 2022 in April.

About CheckMate -816

CheckMate -816 is a randomized, open label trial evaluating Opdivo plus platinum-doublet chemotherapy compared to chemotherapy alone as neoadjuvant treatment in adult patients with resectable non-small cell lung cancer, regardless of PD-L1 expression. ¹ The trial included patients with histologically confirmed Stage IB (≥4 cm), II or IIIA NSCLC (per the 7th edition American Joint Committee on Cancer/Union for International Cancer Control [AJCC/UICC] staging criteria), ECOG performance status 0 or 1, and measurable disease (per RECIST version 1.1). ¹ Patients with unresectable or metastatic NSCLC, known EGFR mutations or ALK translocations, Grade 2 or greater peripheral neuropathy, active autoimmune disease, or medical conditions requiring systemic immunosuppression were excluded from the study. ¹ For the primary analysis, 358 patients were randomized to receive either Opdivo 360 mg plus histology-based platinum doublet chemotherapy on the same day every three weeks for up to three cycles, or platinum doublet chemotherapy every three weeks for up to three cycles, followed by surgery. ¹

The primary endpoints of the trial were EFS determined by Blinded Independent Central Review (BICR) and pCR determined by Blinded Independent Pathology Review (BIPR). ¹ EFS is defined as the length of time from randomization to any of the following events: any progression of disease precluding surgery, progression, or recurrence of disease after surgery, or death due to any cause. ¹ In addition, pCR was defined as 0% residual viable tumor cells in both primary tumor and sampled lymph nodes as assessed by BIPR. ¹ Additional efficacy outcome measures included OS. ¹

Select Safety Profile from CheckMate -816 Study

Adverse reactions leading to the discontinuation of Opdivo plus platinum-doublet chemotherapy occurred in 10% of patients and 30% had at least one treatment withheld for an adverse reaction. ¹ Serious adverse reactions occurred in 30% of patients receiving Opdivo plus platinum-doublet chemotherapy. ¹ Serious adverse reactions in >2% of patients included pneumonia and vomiting. ¹ No fatal adverse reactions occurred in patients who received Opdivo in combination with platinum-doublet chemotherapy. ¹ The most common (>20%) adverse reactions were nausea (38%), constipation (34%), fatigue (26%), decreased appetite (20%), and rash (20%). ¹

About Lung Cancer

Lung cancer is the leading cause of cancer deaths in the United States. ⁴ The two main types of lung cancer are non-small cell and small cell. ⁴ Non-small cell lung cancer is the most common type of lung cancer and accounts for up to 84% of diagnoses. ⁴ Surgery (resection) remains the standard of care for resectable NSCLC and while many patients with NSCLC are treated with surgery, between 30% to 55% of patients develop recurrence and die of their disease despite resection. ^2,3

INDICATIONS

OPDIVO ^® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).

OPDIVO ^® (nivolumab) is indicated for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

OPDIVO ^® (nivolumab), in combination with YERVOY ^® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

OPDIVO ^® (nivolumab), in combination with YERVOY ^® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

OPDIVO ^® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.

OPDIVO ^® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).

IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune-mediated adverse reactions.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.

Immune-Mediated Pneumonitis

OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune- mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (

Immune-Mediated Colitis

OPDIVO and YERVOY can cause immune-mediated colitis, which may be fatal. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%).

Immune-Mediated Hepatitis and Hepatotoxicity

OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3 (1.3%), and Grade 2 (0.4%).

Immune-Mediated Endocrinopathies

OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated.

In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994), including Grade 3 (0.4%) and Grade 2 (0.6%).

In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients, including Grade 3 (0.2%) and Grade 2 (0.3%).

In patients receiving OPDIVO monotherapy, thyroiditis occurred in 0.6% (12/1994) of patients, including Grade 2 (0.2%).

In patients receiving OPDIVO monotherapy, hyperthyroidism occurred in 2.7% (54/1994) of patients, including Grade 3 (

In patients receiving OPDIVO monotherapy, hypothyroidism occurred in 8% (163/1994) of patients, including Grade 3 (0.2%) and Grade 2 (4.8%).

In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients, including Grade 3 (0.4%) and Grade 2 (0.3%), and 2 cases of diabetic ketoacidosis.

Immune-Mediated Nephritis with Renal Dysfunction

OPDIVO and YERVOY can cause immune-mediated nephritis. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients, including Grade 4 (

Immune-Mediated Dermatologic Adverse Reactions

OPDIVO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) has occurred with PD-1/PD-L1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes.

YERVOY can cause immune-mediated rash or dermatitis, including bullous and exfoliative dermatitis, SJS, TEN, and DRESS. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non- bullous/exfoliative rashes.

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).

In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients, including Grade 3 (1.1%) and Grade 2 (2.2%).

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of

In addition to the immune-mediated adverse reactions listed above, across clinical trials of YERVOY monotherapy or in combination with OPDIVO, the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in

Some ocular IMAR cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada–like syndrome, which has been observed in patients receiving OPDIVO and YERVOY, as this may require treatment with systemic corticosteroids to reduce the risk of permanent vision loss.

Infusion-Related Reactions

OPDIVO and YERVOY can cause severe infusion-related reactions. Discontinue OPDIVO and YERVOY in patients with severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Interrupt or slow the rate of infusion in patients with mild (Grade 1) or moderate (Grade 2) infusion-related reactions. In patients receiving OPDIVO monotherapy as a 60-minute infusion, infusion-related reactions occurred in 6.4% (127/1994) of patients. In a separate trial in which patients received OPDIVO monotherapy as a 60-minute infusion or a 30- minute infusion, infusion-related reactions occurred in 2.2% (8/368) and 2.7% (10/369) of patients, respectively. Additionally, 0.5% (2/368) and 1.4% (5/369) of patients, respectively, experienced adverse reactions within 48 hours of infusion that led to dose delay, permanent discontinuation or withholding of OPDIVO.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with OPDIVO or YERVOY. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between OPDIVO or YERVOY and allogeneic HSCT.

Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with OPDIVO and YERVOY prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity

Based on its mechanism of action and findings from animal studies, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. The effects of YERVOY are likely to be greater during the second and third trimesters of pregnancy. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with OPDIVO and YERVOY and for at least 5 months after the last dose.

Increased Mortality in Patients with Multiple Myeloma when OPDIVO is Added to a Thalidomide Analogue and Dexamethasone

In randomized clinical trials in patients with multiple myeloma, the addition of OPDIVO to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.

Lactation

There are no data on the presence of OPDIVO or YERVOY in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 5 months after the last dose.

Serious Adverse Reactions

In Checkmate 238, serious adverse reactions occurred in 18% of patients receiving OPDIVO (n=452). Grade 3 or 4 adverse reactions occurred in 25% of OPDIVO-treated patients (n=452). The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of OPDIVO-treated patients were diarrhea and increased lipase and amylase. In Checkmate 816, serious adverse reactions occurred in 30% of patients (n=176) who were treated with OPDIVO in combination with platinum-doublet chemotherapy. Serious adverse reactions in >2% included pneumonia and vomiting. No fatal adverse reactions occurred in patients who received OPDIVO in combination with platinum-doublet chemotherapy. In Checkmate 227, serious adverse reactions occurred in 58% of patients (n=576). The most frequent (≥2%) serious adverse reactions were pneumonia, diarrhea/colitis, pneumonitis, hepatitis, pulmonary embolism, adrenal insufficiency, and hypophysitis. Fatal adverse reactions occurred in 1.7% of patients; these included events of pneumonitis (4 patients), myocarditis, acute kidney injury, shock, hyperglycemia, multi-system organ failure, and renal failure. In Checkmate 9LA, serious adverse reactions occurred in 57% of patients (n=358). The most frequent (>2%) serious adverse reactions were pneumonia, diarrhea, febrile neutropenia, anemia, acute kidney injury, musculoskeletal pain, dyspnea, pneumonitis, and respiratory failure. Fatal adverse reactions occurred in 7 (2%) patients, and included hepatic toxicity, acute renal failure, sepsis, pneumonitis, diarrhea with hypokalemia, and massive hemoptysis in the setting of thrombocytopenia. In Checkmate 274, serious adverse reactions occurred in 30% of patients receiving OPDIVO (n=351). The most frequent serious adverse reaction reported in ≥2% of patients receiving OPDIVO was urinary tract infection. Fatal adverse reactions occurred in 1% of patients; these included events of pneumonitis (0.6%). In Checkmate 577, serious adverse reactions occurred in 33% of patients receiving OPDIVO (n=532). A serious adverse reaction reported in ≥2% of patients who received OPDIVO was pneumonitis. A fatal reaction of myocardial infarction occurred in one patient who received OPDIVO.

Common Adverse Reactions

In Checkmate 238, the most common adverse reactions (≥20%) reported in OPDIVO-treated patients (n=452) vs ipilimumab-treated patients (n=453) were fatigue (57% vs 55%), diarrhea (37% vs 55%), rash (35% vs 47%), musculoskeletal pain (32% vs 27%), pruritus (28% vs 37%), headache (23% vs 31%), nausea (23% vs 28%), upper respiratory infection (22% vs 15%), and abdominal pain (21% vs 23%). The most common immune mediated adverse reactions were rash (16%), diarrhea/colitis (6%), and hepatitis (3%). In Checkmate 816, the most common (>20%) adverse reactions in the OPDIVO plus chemotherapy arm (n=176) were nausea (38%), constipation (34%), fatigue (26%), decreased appetite (20%), and rash (20%). In Checkmate 227, the most common (≥20%) adverse reactions were fatigue (44%), rash (34%), decreased appetite (31%), musculoskeletal pain (27%), diarrhea/colitis (26%), dyspnea (26%), cough (23%), hepatitis (21%), nausea (21%), and pruritus (21%). In Checkmate 9LA, the most common (>20%) adverse reactions were fatigue (49%), musculoskeletal pain (39%), nausea (32%), diarrhea (31%), rash (30%), decreased appetite (28%), constipation (21%), and pruritus (21%). In Checkmate 274, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=351) were rash (36%), fatigue (36%), diarrhea (30%), pruritus (30%), musculoskeletal pain (28%), and urinary tract infection (22%). In Checkmate 577, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=532) were fatigue (34%), diarrhea (29%), nausea (23%), rash (21%), musculoskeletal pain (21%), and cough (20%).

Please see US Full Prescribing Information for OPDIVO and YERVOY .

Clinical Trials and Patient Populations

Checkmate 238-adjuvant treatment of melanoma; Checkmate 816-neoadjuvant non-small cell lung cancer, in combination with platinum-doublet chemotherapy; Checkmate 227-previously untreated metastatic non-small cell lung cancer, in combination with YERVOY; Checkmate 9LA-previously untreated recurrent or metastatic non-small cell lung cancer in combination with YERVOY and 2 cycles of platinum-doublet chemotherapy by histology; Checkmate 274-adjuvant treatment of urothelial carcinoma; Checkmate 577-adjuvant treatment of esophageal or gastroesophageal junction cancer.

About the Bristol Myers Squibb and Ono Pharmaceutical Collaboration

In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol Myers Squibb further expanded the companies' strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.

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 . Celgene and Juno Therapeutics are wholly owned subsidiaries 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: Creating a Better Future for People with Cancer

Bristol Myers Squibb is inspired by a single vision — transforming patients' 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.

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 Opdivo in combination with Chemotherapy, for the additional indication described in this release will be commercially successful, that any marketing approvals, if granted, may have significant limitations on their use, and that continued approval of such combination treatment for such additional indication described in this release 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

Opdivo Prescribing Information. Opdivo U.S. Product Information. Last Updated: March 2022. Princeton, NJ: Bristol-Myers Squibb Company.
Uramoto H, Tanaka F. Recurrence after surgery in patients with NSCLC. Translational Lung Cancer Research . 2014;3(4).
Sekihara K, Hishida T, Yoshida J, et al. Long-term survival outcome after postoperative recurrence of non-small-cell lung cancer: who is "cured" from postoperative recurrence? European Journal of Cardio-Thoracic Surgery. 2017;52(3):522-528.
American Cancer Society. Key Statistics for Lung Cancer. https://www.cancer.org/cancer/lung-cancer/about/key-statistics.html . Accessed February 16, 2022.
U.S. Food and Drug Administration. Real-Time Oncology Review Pilot Program. https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review . Accessed February 16, 2022.

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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.

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.

U.S. Food and Drug Administration Approves Opdivo® with Chemotherapy as Neoadjuvant Treatment for Certain Adult Patients with Resectable Non-Small Cell Lung Cancer

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