Mantle cell lymphoma refractory

SHANGHAI, Aug. 27, 2024 /PRNewswire/ -- JW Therapeutics (HKEx: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, announced that the National Medical Products Administration (NMPA) of China has approved the supplemental Biological License Application (sBLA) for its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva® (relmacabtagene autoleucel injection) for the treatment of adult patients with relapsed or refractory Mantle Cell Lymphoma (r/r MCL). This is the third marketing approval on Carteyva® submitted by JW Therapeutics, and is the first cell therapy product approved in China for the treatment of patients with r/r MCL. Carteyva® was granted, by NMPA, Breakthrough Therapy Designation in Mar 2022, as well as Priority Review in Dec 2023. MCL is a heterogeneous B cell non-Hodgkin lymphoma which is currently incurable with existing therapies[1]. MCL, associated with a poor prognosis, mainly occurs in elderly men who were not diagnosed until advanced stage[2]. Significant progress has been made in the last decade as the treatment paradigm has shifted from traditional chemoimmunotherapy toward targeted therapies such as bruton tyrosine kinase inhibitors (BTKi). Despite the use of BTKi in r/r MCL has improved their survival outcomes, many patients will ultimately relapse with shortened remission durations (6~10 months) [3]. Notwithstanding the above, there are still unmet medical needs for a safe, effective novel approach to overcome the limitations of current treatments of r/r MCL. The sBLA was supported by the clinical results from a single-arm, multi-center, pivotal study on Carteyva® in adult patients with r/r MCL in China. In the study, patients with r/r MCL who had been treated with a CD20-targeting antibody, anthracycline or bendamustine, or BTKis were included. After being treated with lymphodepleting chemotherapy, patients received Carteyva® (100×106 CAR+ T cells). As of August 7th, 2023, a total of 59 patients received Carteyva® infusion. Of 59 efficacy evaluable patients, Carteyva® demonstrated remarkable clinical responses achieving high rates of objective response rate (ORR) and complete response rate (CRR) (best ORR 81.36%, best CRR 67.80%) and the incidence of severe (grade ≥ 3) cytokine release syndrome (CRS) was 6.8%, the incidence of severe (grade ≥ 3) neurotoxicity (NT) was 6.8%. Sophia Yang, Senior Vice President and Head of Regulatory, Research & Development of JW Therapeutics, noted: "We are delighted to have a product that can deliver meaningful efficacy in this disease, nearly 70% of patients with r/r MCL have achieved complete remission after treatment with Carteyva®, and the overall safety data demonstrated that the treatment was generally well-tolerated. Carteyva® becomes the first commercial CAR-T cell product for the treatment of r/r MCL in China." References The consensus of the diagnosis and treatment of mantle cell lymphoma in China (2016 version). Chin J Hematol.2016, 37(9):735-741. Herrmann A, Hoster E, Zwingers T, et al. Improvement of Overall Survival in Advanced Stage Mantle Cell Lymphoma[J]. Journal of Clinical Oncology, 2009, 27(4):511-518. Burkart M, Karmali R. Relapsed/Refractory Mantle Cell Lymphoma: Beyond BTK Inhibitors. J Pers Med. 2022 Mar 1;12(3):376. About Relmacabtagene Autoleucel Injection Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name for oncology indications: Carteyva®) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, Carteyva® has been approved by the China National Medical Products Administration (NMPA) for three indications, including the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBLC) after two or more lines of systemic therapy, the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL), and the treatment of adult patients with relapsed or refractory mantle cell lymphoma ("r/r MCL") after two or more lines of systemic therapy including bruton tyrosine kinase inhibitors ("BTKi"), making it the first CAR-T product approved as a Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, priority review and breakthrough therapy designations. About JW Therapeutics JW Therapeutics (HKEx:2126) is an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products. Since its founding in 2016, JW Therapeutics has built an integrated platform for product development in cell immunotherapy, as well as a product pipeline covering hematologic malignancies, solid tumors and autoimmune diseases. JW Therapeutics is committed to bringing breakthrough and quality cell immunotherapy products and the hope of a cure to patients in China and beyond, and to leading the healthy and standardized development of China's cell immunotherapy industry. For more information, please visit . Forward-Looking Statements The forward-looking statements are based on the management's expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described. Significant risks and uncertainties, include those discussed below and more fully described in Hong Kong Exchanges and Clearing Limited (HKEx) reports filed by the Company. Unless otherwise noted, the Company is providing this information as of the date it publicized, and expressly disclaims any duty to update information contained in the issues and relevant information, or provide any explanation. For detailed information, please visit the company website: . SOURCE JW Therapeutics

Application based on the TRANSCEND FL trial in which Breyanzi showed deep and durable responses and a consistent and well-established safety profile Breyanzi also received approval in Japan for the treatment of relapsed or refractory follicular lymphoma (FL) after one prior line of systemic therapy in patients with high-risk FL and after two or more lines of systemic therapy, making it the first and only CAR T treatment approved for this high-risk population with unmet need PRINCETON, NJ, USA I August 19, 2024 I Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency (EMA) has validated its Type II variation application to expand the indication for Breyanzi ® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. Validation of the application confirms the submission is complete and allows the scientific review to begin under the EMA’s centralized review procedure. “Follicular lymphoma impacts a significant number of people, and those with relapsed or refractory disease tend to experience shorter responses with each new line of therapy,” said Anne Kerber, senior vice president, head of Late Clinical Development, Hematology, Oncology and Cell Therapy (HOCT), Bristol Myers Squibb. “ Breyanzi represents a differentiated CAR T cell therapy, and we look forward to working with the European Medicines Agency to bring this important treatment option to patients with relapsed or refractory follicular lymphoma with the goal of improving outcomes and providing lasting remission.” The application is supported by data from the Phase 2 TRANSCEND FL study, the largest clinical trial to date to evaluate a CAR T cell therapy in patients with relapsed or refractory indolent non-Hodgkin lymphoma (NHL), including FL. The study enrolled adults with relapsed or refractory FL treated with Breyanzi in the high-risk second-line and third-line plus setting. In the study, Breyanzi demonstrated a high overall response rate, the study’s primary endpoint, with responses being deep and durable. The safety of Breyanzi in FL is consistent with the well-established and manageable safety profile of Breyanzi observed across clinical trials. Follicular lymphoma is the second most common form of NHL, accounting for 20 to 30 percent of all NHL cases. FL has historically been considered an incurable disease with patients frequently relapsing following front-line therapy and prognosis worsening after each subsequent relapse. Despite advances in treatment, there remains an unmet need for additional options that offer treatment-free intervals with durable, complete responses. Breyanzi is currently approved in the European Union for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and FL grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy, and for the treatment of adult patients with relapsed or refractory DLBCL, PMBCL, and FL3B after two or more lines of systemic therapy. A supplemental New Drug Application for Breyanzi for the treatment of relapsed or refractory follicular lymphoma after one prior line of systemic therapy in patients with high-risk FL and after two or more lines of systemic therapy has also been approved by Japan’s Ministry of Health, Labour and Welfare based on results of the TRANSCEND FL study, making it the first CAR T approved in the second-line setting anywhere and the third approval for Breyanzi in Japan. About TRANSCEND FL TRANSCEND FL (NCT04245839) is an open-label, global, multicenter, Phase 2, single-arm study to determine the efficacy and safety of Breyanzi in adult patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma, including follicular lymphoma. The primary outcome measure is overall response rate, including best overall response of complete response or partial response as determined by an Independent Review Committee. Secondary outcome measures include complete response rate, duration of response, progression-free survival, and safety. About Breyanzi Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells. Breyanzi is made from a patient’s own T cells, which are collected and genetically reengineered to become CAR T cells that are then delivered via infusion as a one-time treatment. Breyanzi is approved in the U.S. for the treatment of relapsed or refractory large B-cell lymphoma (LBCL) after at least one prior line of therapy, has received accelerated approval for the treatment of relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior lines of therapy and relapsed or refractory follicular lymphoma in the third-line plus setting, and is approved for the treatment of relapsed or refractory mantle cell lymphoma (MCL) in the third-line plus setting. Breyanzi is also approved in Japan, the European Union (EU), and Switzerland for the second-line treatment of relapsed or refractory LBCL; in Japan, the EU, Switzerland, the UK and Canada for relapsed and refractory LBCL after two or more lines of systemic therapy; and in Japan for the treatment of relapsed or refractory patients with high-risk follicular lymphoma after one prior line of systemic therapy and in patients after two or more lines of systemic therapy. Bristol Myers Squibb’s clinical development program for Breyanzi includes clinical studies in other types of lymphoma. For more information, visit clinicaltrials.gov . Full European Summary of Product Characteristics for Breyanzi is available from the EMA website at www.ema.europa.eu . U.S. FDA-Approved Indications BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma. Please see full Prescribing Information , including Boxed WARNINGS and Medication Guide . 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 understanding of causal human biology, cutting-edge capabilities and differentiated research platforms uniquely position the company to approach 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. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future. Learn more about the science behind cell therapy and ongoing research at Bristol Myers Squibb here . 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 . SOURCE: Bristol Myers Squibb

PRINCETON, N.J.--( BUSINESS WIRE )-- Bristol Myers Squibb (NYSE: BMY) today reports results for the second quarter of 2024. “ Our second quarter results reflect progress against our strategy to position BMS for long-term, sustainable growth,” said Christopher Boerner, Ph.D. , board chair and chief executive officer, Bristol Myers Squibb. “ As we move into the second half of the year, we remain focused on prioritizing opportunities with the greatest growth potential and impact for patients, including the anticipated U.S. launch of KarXT. We're also driving operational excellence throughout the company, becoming more agile and strengthening execution." Second Quarter $ in millions, except per share amounts 2024 2023 Change Change Excl. F/X** Total Revenues $12,201 $11,226 9% 11% Earnings Per Share — GAAP* 0.83 0.99 (16)% N/A Earnings Per Share — Non-GAAP* ** 2.07 1.75 18% N/A Acquired IPRD charge and Licensing Income Net Impact on Earnings Per Share (0.04 ) (0.05 ) N/A N/A * GAAP and Non-GAAP earnings per share include the net impact of Acquired IPRD charges and licensing income. ** See "Use of Non-GAAP Financial Information". SECOND QUARTER RESULTS All comparisons are made versus the same period in 2023 unless otherwise stated. Bristol Myers Squibb posted second quarter revenues of $12.2 billion, an increase of 9%, or 11% when adjusted for foreign exchange impacts, primarily driven by the Growth Portfolio and Eliquis . U.S. revenues increased 13% to $8.8 billion, primarily due to the Growth and Legacy Portfolios . International revenues decreased 1% to $3.4 billion, primarily due to the negative impact from foreign exchange of 7% and Revlimid , partially offset by Opdivo . On a GAAP basis, gross margin decreased from 74.4% to 73.2%, primarily due to a one-time impairment charge related to marketed product rights. On a non-GAAP basis, gross margin increased from 75.0% to 75.6% due to product mix. On a GAAP and non-GAAP basis, marketing, selling and administrative expenses remained relatively flat at $1.9 billion. On a GAAP basis, research and development expenses increased 28% to $2.9 billion, primarily due to an IPRD impairment charge resulting from the decision to discontinue further development of alnuctamab. On a non-GAAP basis, research and development expenses remained relatively flat at $2.3 billion. On a GAAP and non-GAAP basis, Acquired IPRD decreased to $132 million from $158 million. On a GAAP and non-GAAP basis, licensing income was $37 million compared to $20 million. On a GAAP basis, amortization of acquired intangible assets increased 7% to $2.4 billion, primarily due to the RayzeBio acquisition in 2024 and approval of Augtyro in the fourth quarter of 2023. On a GAAP basis, income tax benefit was $398 million despite pre-tax earnings of $1.3 billion, primarily due to the release of income tax reserves. On a non-GAAP basis, effective tax rate changed from 16.9% to 14.1%, primarily due to the release of income tax reserves. On a GAAP basis, the company reported net income attributable to Bristol Myers Squibb of $1.7 billion, or $0.83 per share, during the second quarter of 2024 compared to $2.1 billion, or $0.99 per share, for the same period a year ago. In addition to the items above, the decrease was also due to higher interest expense resulting from new debt issuance to fund recent acquisitions. The company reported non-GAAP net earnings attributable to Bristol Myers Squibb of $4.2 billion, or $2.07 per share, during the second quarter of 2024 compared to $3.7 billion, or $1.75 per share, for the same period a year ago. SECOND QUARTER PRODUCT REVENUE HIGHLIGHTS ($ amounts in millions) Quarter Ended June 30, 2024 % Change from Quarter Ended June 30, 2023 % Change from Quarter Ended June 30, 2023 Ex-F/X** U.S. Int'l (c) WW (d) U.S. Int'l (c) WW (d) Int'l (c) WW (d) Growth Portfolio Opdivo $ 1,406 $ 981 $ 2,387 15% 6% 11% 18% 16% Orencia 742 206 948 7% (11)% 2% (2)% 5% Yervoy 404 226 630 10% 4% 8% 11% 10% Reblozyl 348 77 425 96% 38% 82% 41% 82% Opdualag 223 12 235 48% * 53% * 53% Abecma 54 41 95 (53)% * (28)% * (27)% Zeposia 111 40 151 52% 48% 51% 48% 51% Breyanzi 122 31 153 47% 82% 53% 94% 55% Camzyos 130 9 139 * N/A * N/A * Sotyktu 41 12 53 71% * * * * Augtyro 7 — 7 N/A N/A N/A N/A N/A Krazati 29 3 32 N/A N/A N/A N/A N/A Other Growth Products (a) 168 173 341 4% 30% 16% 35% 18% Total Growth Portfolio 3,785 1,811 5,596 21% 11% 18% 21 % 21% Legacy Portfolio Eliquis 2,544 872 3,416 10% (2)% 7% —% 7% Revlimid 1,165 188 1,353 (4)% (24)% (8)% (20)% (7)% Pomalyst/Imnovid 716 243 959 27% (14)% 13% (11)% 14% Sprycel 341 83 424 6% (39)% (7)% (34)% (6)% Abraxane 154 77 231 (18)% 8% (10)% 25% (6)% Other Legacy Products (b) 96 126 222 16% (24)% (10)% (19)% (8)% Total Legacy Portfolio 5,016 1,589 6,605 7% (11)% 2% (8)% 3% Total Revenues $ 8,801 $ 3,400 $ 12,201 13% (1)% 9% 6% 11% * In excess of +100%. ** See "Use of Non-GAAP Financial Information". (a) Includes Nulojix, Onureg, Inrebic, Empliciti and royalty revenue. (b) Includes other mature brands. (c) Beginning in 2024, Puerto Rico revenues are included in International revenues. Prior period amounts have been reclassified to conform to the current presentation. (d) Worldwide (WW) includes U.S. and International (Int'l). SECOND QUARTER PRODUCT REVENUE HIGHLIGHTS Growth Portfolio Growth Portfolio worldwide revenues increased to $5.6 billion compared to $4.7 billion in the prior year period, representing growth of 18% on a reported basis, or 21% when adjusted for foreign exchange impacts. Growth Portfolio revenues were primarily driven by higher demand for Opdivo , Reblozyl, Camzyos and Opdualag, partially offset by Abecma . Legacy Portfolio Revenues for the Legacy Portfolio in the second quarter were $6.6 billion compared to $6.5 billion in the prior year period, representing growth of 2% on a reported basis, or 3% when adjusted for foreign exchange impacts. Legacy Portfolio revenues were driven by higher demand for Eliquis and Pomalyst , partially offset by a decline in Revlimid due to generic erosion. PRODUCT AND PIPELINE UPDATE Bristol Myers Squibb recently achieved several important clinical and regulatory milestones. Today, the company is announcing that the Phase 3 trial evaluating the efficacy and safety of cendakimab in patients with eosinophilic esophagitis (EoE) met both co-primary endpoints. The company will work with key investigators to present detailed results at an upcoming medical conference. Multiple regulatory approvals were received during the second quarter, including U.S. Food and Drug Administration (FDA) approval for Breyanzi to expand into follicular lymphoma and mantle cell lymphoma. In addition, the FDA and the European Medicines Agency (EMA) are each currently evaluating an application from the company for the approval of subcutaneous nivolumab. Oncology Category Asset Milestone Regulatory Opdivo ® (nivolumab) + Yervoy ® (ipilimumab) The EMA validated the Type II variation application for Opdivo plus Yervoy as a potential first-line treatment option for adult patients with unresectable or advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy. The application was based on results from the Phase 3 CheckMate -9DW trial. Validation confirms the submission is complete and begins the EMA's centralized review procedure. Krazati ® (adagrasib) The FDA granted accelerated approval for Krazati in combination with cetuximab as a targeted treatment option for adult patients with KRAS G12C -mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. The approval is based on results from the Phase 1/2 KRYSTAL-1 study. Subcutaneous nivolumab The EMA validated the extension application to introduce a new route of administration (subcutaneous use) for nivolumab that includes a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial) across multiple previously approved adult solid tumor indications as monotherapy, monotherapy maintenance following completion of nivolumab plus ipilimumab combination therapy, or in combination with chemotherapy or cabozantinib. The validation, based on results from the Phase 3 CheckMate -67T trial, confirms the submission is complete and begins the EMA’s centralized review procedure. Augtyro™ (repotrectinib) The FDA granted accelerated approval of Augtyro for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. The approval is based on results from the Phase 1/2 TRIDENT-1 trial. Opdivo The European Commission (EC) approved Opdivo in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC). The approval makes Opdivo in combination with cisplatin and gemcitabine the first concurrent immunotherapy-chemotherapy approved for the treatment of adult patients with unresectable or metastatic UC in the first-line setting in the European Union. The approval is based on the results from the CheckMate -901 trial. Opdivo + Yervoy The EMA validated the Type II variation application for Opdivo plus Yervoy for the first-line treatment of adult patients with microsatellite instability–high or mismatch repair deficient metastatic CRC. The application is based on results from the Phase 3 CheckMate -8HW trial. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process. Subcutaneous nivolumab The FDA accepted the Biologics License Application (BLA) for the subcutaneous formulation of nivolumab co-formulated with Halozyme’s proprietary recombinant human hyaluronidase across all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy combination therapy, or in combination with chemotherapy or cabozantinib. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 29, 2024. Clinical & Research Opdivo + Yervoy Results from the Phase 3 CheckMate -9DW trial showed the dual immunotherapy combination of Opdivo plus Yervoy meaningfully improved overall survival, the trial’s primary endpoint, compared to investigator’s choice of lenvatinib or sorafenib as a first-line treatment for patients with unresectable HCC. The results also demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of objective response rate. Krazati Results from the Phase 3 KRYSTAL-12 study evaluating Krazati compared to standard of care chemotherapy in patients with locally advanced or metastatic KRAS G12C -mutated NSCLC who had previously received platinum-based chemotherapy, concurrently or sequentially with anti-PD-(L)1 therapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), the study’s primary endpoint. The KRYSTAL-12 study remains ongoing to assess the additional key secondary endpoint of overall survival. Opdivo + Yervoy The Phase 3 CheckMate -73L trial did not meet its primary endpoint of PFS in unresectable, locally advanced stage III NSCLC. CheckMate -73L evaluated Opdivo with concurrent chemoradiotherapy (CCRT) followed by Opdivo plus Yervoy versus CCRT followed by durvalumab in patients with unresectable stage III NSCLC. Hematology Category Asset Milestone Regulatory Breyanzi ® (lisocabtagene maraleucel) The FDA approved Breyanzi for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor. This FDA approval is based on results from the MCL cohort of the Phase 1 TRANSCEND NHL 001 trial. Breyanzi The FDA granted accelerated approval for Breyanzi for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. The approval is based on results from the Phase 2 TRANSCEND FL trial. Immunology Category Asset Milestone Clinical & Research cendakimab The pivotal Phase 3 trial evaluating the efficacy and safety of cendakimab in patients with EoE met both co-primary endpoints, demonstrating statistically significant reductions versus placebo in symptoms (dysphagia days) and esophageal eosinophil counts after 24 weeks of treatment. The overall safety profile of cendakimab through 48 weeks of treatment in the Phase 3 trial was consistent with previously reported EoE Phase 2 trial results, and no new safety signals were identified. Sotyktu ® (deucravacitinib) Four-year results from the POETYK PSO long-term extension trial of Sotyktu treatment in adult patients with moderate-to-severe plaque psoriasis showed that, after four years of continuous Sotyktu treatment, clinical response was maintained in more than seven out of 10 patients for Psoriasis Area and Severity Index 75. In addition, the safety profile of Sotyktu at Year 4 remained consistent with the established safety profile, with no new safety signals identified. Financial Guidance Bristol Myers Squibb is raising portions of its 2024 line-item guidance as noted below. 2024 Line-Item Guidance Non-GAAP 2 April (Prior) July (Updated) Total Revenues Low single-digit increase Upper end of low single- digit range Total Revenues (excl. F/X) Low single-digit increase Upper end of low single- digit range Gross Margin % ~74% Between ~74% and ~75% Operating Expenses 1 Low single-digit increase No Change Other income/(expense) ~($250M) ~($50M) Effective tax rate ~69% ~66% Diluted EPS $0.40 - $0.70 $0.60 - $0.90 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." The 2024 financial guidance excludes the impact of any potential future strategic acquisitions, divestitures, specified items that have not yet been identified and quantified, and the impact of future Acquired IPRD charges. To the extent we have quantified the impact of significant R&D charges or other income resulting from upfront or contingent milestone payments in connection with asset acquisitions or licensing of third-party intellectual property rights, we may update this information from time to time on our website www.bms.com , in the "Investors" section. Non-GAAP guidance assumes current exchange rates. The financial guidance is subject to risks and uncertainties applicable to all forward-looking statements as described elsewhere in this press release. A reconciliation of forward-looking non-GAAP measures, including non-GAAP EPS, to the most directly comparable GAAP measures is not provided because comparable GAAP measures for such measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and quantifying measures that would be necessary for such reconciliation. Namely, we are not, without unreasonable effort, able to reliably predict the impact of accelerated depreciation and impairment charges, legal and other settlements, gains and losses from equity investments and other adjustments. In addition, the company believes such a reconciliation would imply a degree of precision and certainty that could be confusing to investors. These items are uncertain, depend on various factors and may have a material impact on our future GAAP results. See "Cautionary Statement Regarding Forward-Looking Statements" and "Use of Non-GAAP Financial Information." Environmental, Social & Governance (ESG) As a leading biopharmaceutical company, Bristol Myers Squibb's passion for making an impact extends beyond the discovery, development and delivery of innovative medicines that help patients prevail over serious diseases. To learn more about our priorities and goals, please visit our latest ESG report . In June 2024, Bristol Myers Squibb was added to the 2023 Dow Jones Sustainability Index North America. This reflects the company's evolved strategy and meaningful progress on its ESG efforts. On May 22, 2024, the company announced ASPIRE (Accessibility, Sustainability, Patient-centric, Impact, Responsibility and Equity), a 10-year strategy to advance access to the company's innovative treatments and help patients in low- and middle-income countries (LMICs) gain access to potentially life-saving medicines. This strategy supports the company's commitment to reach more than 200,000 patients in LMICs by 2033 with its innovative treatments. Conference Call Information Bristol Myers Squibb will host a conference call today, Friday, July 26, 2024, at 8:00 a.m. ET, during which company executives will review quarterly financial results and address inquiries from investors and analysts. Investors and the general public are invited to listen to a live webcast of the call at http://investor.bms.com . Investors and the public can register for the live conference call here . Those unable to register can access the live conference call by dialing in the U.S. toll-free 1-833-816-1116 or international +1 412-317-0705. Materials related to the call will be available at http://investor.bms.com prior to the start of the conference call. A replay of the webcast will be available at http://investor.bms.com approximately three hours after the conference call concludes. A replay of the conference call will be available beginning at 11:30 a.m. ET on July 26, 2024, through 11:30 a.m. ET on August 9, 2024, by dialing in the U.S. toll free 1-877-344-7529 or international +1 412-317-0088, confirmation code: 2169814. 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 , X (formerly Twitter), YouTube , Facebook , and Instagram . corporatefinancial-news Use of Non-GAAP Financial Information In discussing financial results and guidance, the company refers to financial measures that are not in accordance with U.S. Generally Accepted Accounting Principles (GAAP). The non-GAAP financial measures are provided as supplemental information to the financial measures presented in this press release that are calculated and presented in accordance with GAAP and are presented because management has evaluated the company’s financial results both including and excluding the adjusted items or the effects of foreign currency translation, as applicable, and believes that the non-GAAP financial measures presented portray the results of the company's baseline performance, supplement or enhance management's, analysts' and investors' overall understanding of the company’s underlying financial performance and trends and facilitate comparisons among current, past and future periods. In addition, non-GAAP gross margin, which is gross profit excluding certain specified items, as a percentage of revenues, non-GAAP operating margin, which is gross profit less marketing, selling and administrative expenses and research and development expenses excluding certain specified items as a percentage of revenues, non-GAAP operating expenses, which is marketing, selling and administrative and research and development expenses excluding certain specified items, non-GAAP marketing, selling and administrative expenses, which is marketing, selling and administrative expenses excluding certain specified items, and non-GAAP research and development expenses, which is research and development expenses excluding certain specified items, are relevant and useful for investors because they allow investors to view performance in a manner similar to the method used by our management and make it easier for investors, analysts and peers to compare our operating performance to other companies in our industry and to compare our year-over-year results. This earnings release and the accompanying tables also provide certain revenues and expenses as well as non-GAAP measures excluding the impact of foreign exchange ("Ex-Fx"). We calculate foreign exchange impacts by converting our current-period local currency financial results using the prior period average currency rates and comparing these adjusted amounts to our current-period results. Ex-Fx financial measures are not accounted for according to GAAP because they remove the effects of currency movements from GAAP results. Non-GAAP financial measures such as non-GAAP earnings and related EPS information are adjusted to exclude certain costs, expenses, gains and losses and other specified items that are evaluated on an individual basis after considering their quantitative and qualitative aspects and typically have one or more of the following characteristics, such as being highly variable, difficult to project, unusual in nature, significant to the results of a particular period or not indicative of past or future operating results. These items are excluded from non-GAAP earnings and related EPS information because the company believes they neither relate to the ordinary course of the company’s business nor reflect the company’s underlying business performance. Similar charges or gains were recognized in prior periods and will likely reoccur in future periods, including amortization of acquired intangible assets, including product rights that generate a significant portion of our ongoing revenue and will recur until the intangible assets are fully amortized, unwind of inventory purchase price adjustments, acquisition and integration expenses, restructuring costs, accelerated depreciation and impairment of property, plant and equipment and intangible assets, costs of acquiring a priority review voucher, divestiture gains or losses, stock compensation resulting from acquisition-related equity awards, pension, legal and other contractual settlement charges, equity investment and contingent value rights fair value adjustments (including fair value adjustments attributed to limited partnership equity method investments), income resulting from the change in control of the Nimbus Therapeutics TYK2 Program and amortization of fair value adjustments of debt acquired from Celgene in our 2019 exchange offer, among other items. Deferred and current income taxes attributed to these items are also adjusted for considering their individual impact to the overall tax expense, deductibility and jurisdictional tax rates. Certain other significant tax items are also excluded such as the impact resulting from a non-U.S. tax ruling regarding the deductibility of a statutory impairment of subsidiary investments and release of income tax reserves relating to the Celgene acquisition. Because the non-GAAP financial measures are not calculated in accordance with GAAP, they should not be considered superior to and are not intended to be considered in isolation or as a substitute for the related financial measures presented in the press release that are prepared in accordance with GAAP and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted. We encourage investors to review our financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure. Reconciliations of the non-GAAP financial measures to the most comparable GAAP measures are provided in the accompanying financial tables and will also be available on the company’s website at www.bms.com . Within the accompanying financial tables presented, certain columns and rows may not add due to the use of rounded numbers. Percentages and earnings per share amounts presented are calculated from the underlying amounts. A reconciliation of forward-looking non-GAAP measures, including non-GAAP EPS, to the most directly comparable GAAP measures is not provided because comparable GAAP measures for such measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and quantifying measures that would be necessary for such reconciliation. Namely, we are not, without unreasonable effort, able to reliably predict the impact of accelerated depreciation and impairment charges, legal and other settlements, gains and losses from equity investments and other adjustments. In addition, the company believes such a reconciliation would imply a degree of precision and certainty that could be confusing to investors. These items are uncertain, depend on various factors and may have a material impact on our future GAAP results. Website Information We routinely post important information for investors on our website, BMS.com, in the “Investors” section. We may use this website as a means of disclosing material, non-public information and for complying with our disclosure obligations under Regulation FD. Accordingly, investors should monitor the Investors section of our website, in addition to following our press releases, Securities and Exchange Commission ("SEC") filings, public conference calls, presentations and webcasts. We may also use social media channels to communicate with our investors and the public about our company, our products and other matters, and those communications could be deemed to be material information. The information contained on, or that may be accessed through, our website or social media channels are not incorporated by reference into, and are not a part of, this document. Cautionary Statement Regarding Forward-Looking Statements This earnings release and the related attachments (as well as the oral statements made with respect to information contained in this release and the attachments) contain certain “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, regarding, among other things, the company’s 2024 financial guidance, plans and strategy, including its business development and capital allocation strategy, ESG priorities and goals, anticipated developments in the company’s pipeline, expectations with respect to the company’s future market position and the projected benefits of the company’s alliances and other business development activities. These statements may be identified by the fact that they use words such as “should,” “could,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe,” “will” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance, although not all forward-looking statements contain such terms. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. No forward-looking statement can be guaranteed and there is no assurance that the company will achieve its financial guidance and long-term targets, that the company’s future clinical studies will support the data described in this release, that the company’s product candidates will receive necessary clinical and manufacturing regulatory approvals, that the company’s pipeline products will prove to be commercially successful, that clinical and manufacturing regulatory approvals will be sought or obtained within currently expected timeframes, or that contractual milestones will be achieved. Forward-looking statements are based on current expectations and projections about the company’s 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 the company’s control and could cause the company’s future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. Such risks, uncertainties and other matters include, but are not limited to: increasing pricing pressures from market access, pharmaceutical pricing controls and discounting; market actions taken by private and government payers to manage drug utilization and contain costs; the company’s ability to retain patent exclusivity of certain products; regulatory changes that result in lower prices, lower reimbursement rates and smaller populations for whom payers will reimburse; changes under the 340B Drug Pricing Program; the company’s ability to obtain and maintain regulatory approval for its product candidates; the company’s ability to obtain and protect market exclusivity rights and enforce patents and other intellectual property rights; the possibility of difficulties and delays in product introduction and commercialization; increasing industry competition; potential difficulties, delays and disruptions in manufacturing, distribution or sale of products; the company’s ability to identify potential strategic acquisitions, licensing opportunities or other beneficial transactions; failure to complete, or delays in completing, collaborations, acquisitions, divestitures, alliances and other portfolio actions and the failure to achieve anticipated benefits from such transactions and actions; the risk of an adverse patent litigation decision or settlement and exposure to other litigation and/or regulatory actions or investigations; the impact of any healthcare reform and legislation or regulatory action in the United States and international markets; increasing market penetration of lower-priced generic products; the failure of the company’s suppliers, vendors, outsourcing partners, alliance partners and other third parties to meet their contractual, regulatory and other obligations; the impact of counterfeit or unregistered versions of the company’s products and from stolen products; product label changes or other measures that could reduce the product's market acceptance for the company's products and result in declining sales; safety or efficacy concerns regarding the company’s products or any product in the same class as the company’s products; the risk of cyber-attacks on the company’s information systems or products and unauthorized disclosure of trade secrets or other confidential data; the company’s ability to execute its financial, strategic and operational plans; the company’s dependency on several key products; any decline in the company’s future royalty streams; the company’s ability to attract and retain key personnel; the impact of the company’s significant indebtedness; political and financial instability of international economies and sovereign risk; interest rate and currency exchange rate fluctuations, credit and foreign exchange risk management; risks relating to the use of social media platforms; the impact of our exclusive forum provision in our by-laws for certain lawsuits on our stockholders’ ability to obtain a judicial forum that they find favorable for such lawsuits; issuance of new or revised accounting standards; and risks relating to public health outbreaks, epidemics and pandemics. Forward-looking statements in this earnings release should be evaluated together with the many risks and uncertainties that affect the company’s business and market, particularly those identified in the cautionary statement and risk factors discussion in the company’s Annual Report on Form 10-K for the year ended December 31, 2023, as updated by the company’s subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC. 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, the company 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. BRISTOL-MYERS SQUIBB COMPANY CONSOLIDATED STATEMENTS OF EARNINGS (Unaudited, dollars and shares in millions except per share data) Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Net product sales $ 11,925 $ 10,917 $ 23,484 $ 21,965 Alliance and other revenues 276 309 582 598 Total Revenues 12,201 11,226 24,066 22,563 Cost of products sold (a) 3,267 2,876 6,199 5,442 Marketing, selling and administrative 1,928 1,934 4,295 3,696 Research and development 2,899 2,258 5,594 4,579 Acquired IPRD 132 158 13,081 233 Amortization of acquired intangible assets 2,416 2,257 4,773 4,513 Other (income)/expense, net 273 (116 ) 354 (529 ) Total Expenses 10,915 9,367 34,296 17,934 (Loss)/Earnings Before Income Taxes 1,286 1,859 (10,230 ) 4,629 Provision for Income Taxes (398 ) (218 ) (6 ) 285 Net (Loss)/Earnings 1,684 2,077 (10,224 ) 4,344 Noncontrolling Interest 4 4 7 9 Net (Loss)/Earnings Attributable to BMS $ 1,680 $ 2,073 $ (10,231 ) $ 4,335 Weighted-Average Common Shares Outstanding: Basic 2,027 2,093 2,025 2,096 Diluted 2,029 2,102 2,025 2,107 (Loss)/Earnings per Common Share: Basic $ 0.83 $ 0.99 $ (5.05 ) $ 2.07 Diluted 0.83 0.99 (5.05 ) 2.06 Other (income)/expense, net Interest expense (b) $ 521 $ 282 $ 946 $ 570 Royalty and licensing income (191 ) (340 ) (352 ) (703 ) Royalty income - divestitures (265 ) (218 ) (536 ) (406 ) Equity investment (gains)/losses (107 ) 58 (209 ) 213 Integration expenses 74 59 145 126 Litigation and other settlements 69 (7 ) 71 (332 ) Investment income (87 ) (95 ) (270 ) (197 ) Provision for restructuring 260 113 480 180 Acquisition expense 1 — 50 — Other (2 ) 32 29 20 Other (income)/expense, net $ 273 $ (116 ) $ 354 $ (529 ) (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 JUNE 30, 2024 AND 2023 (Unaudited, dollars in millions) Change vs. 2023 2024 2023 GAAP Excl. F/X** U.S. Int'l (c) WW (d) U.S. Int'l (c) WW (d) U.S. Int'l (c) WW (d) U.S. Int'l (c) WW (d) Growth Portfolio Opdivo $ 1,406 $ 981 $ 2,387 $ 1,221 $ 924 $ 2,145 15% 6% 11% 15% 18% 16% Orencia 742 206 948 695 232 927 7% (11)% 2% 7% (2)% 5% Yervoy 404 226 630 368 217 585 10% 4% 8% 10% 11% 10% Reblozyl 348 77 425 178 56 234 96% 38% 82% 96% 41% 82% Opdualag 223 12 235 151 3 154 48% * 53% 48% * 53% Abecma 54 41 95 115 17 132 (53)% * (28)% (53)% * (27)% Zeposia 111 40 151 73 27 100 52% 48% 51% 52% 48% 51% Breyanzi 122 31 153 83 17 100 47% 82% 53% 47% 94% 55% Camzyos 130 9 139 46 — 46 * N/A * * N/A * Sotyktu 41 12 53 24 1 25 71% * * 71% * * Augtyro 7 — 7 — — — N/A N/A N/A N/A N/A N/A Krazati 29 3 32 — — — N/A N/A N/A N/A N/A N/A Other Growth Products (a) 168 173 341 162 133 295 4% 30% 16% 4% 35% 18% Total Growth Portfolio 3,785 1,811 5,596 3,116 1,627 4,743 21% 11 % 18% 21 % 21% 21% Legacy Portfolio Eliquis 2,544 872 3,416 2,311 893 3,204 10% (2)% 7% 10% —% 7% Revlimid 1,165 188 1,353 1,219 249 1,468 (4)% (24)% (8)% (4)% (20)% (7)% Pomalyst/Imnovid 716 243 959 565 282 847 27% (14)% 13% 27% (11)% 14% Sprycel 341 83 424 323 135 458 6% (39)% (7)% 6% (34)% (6)% Abraxane 154 77 231 187 71 258 (18)% 8% (10)% (18)% 25% (6)% Other Legacy Products (b) 96 126 222 83 165 248 16% (24)% (10)% 16% (19)% (8)% Total Legacy Portfolio 5,016 1,589 6,605 4,688 1,795 6,483 7% (11)% 2% 7% (8)% 3% Total Revenues $ 8,801 $ 3,400 $ 12,201 $ 7,804 $ 3,422 $ 11,226 13% (1)% 9% 13% 6% 11% * In excess of +100%. ** See "Use of Non-GAAP Financial Information". (a) Includes Onureg , Inrebic, Nulojix , Empliciti and royalty revenues. (b) Includes other mature brands. (c) Beginning in 2024, Puerto Rico revenues are included in International revenues. Prior period amounts have been reclassified to conform to the current presentation. (d) Worldwide (WW) includes U.S. and International (Int'l). BRISTOL-MYERS SQUIBB COMPANY PRODUCT REVENUES FOR THE SIX MONTHS ENDED JUNE 30, 2024 AND 2023 (Unaudited, dollars in millions) Change vs. 2023 2024 2023 GAAP Excl. F/X** U.S. Int'l (c) WW (d) U.S. Int'l (c) WW (d) U.S. Int'l (c) WW (d) U.S. Int'l (c) WW (d) Growth Portfolio Opdivo $ 2,561 $ 1,904 $ 4,465 $ 2,502 $ 1,845 $ 4,347 2% 3% 3% 2% 13% 7% Orencia 1,314 432 1,746 1,246 445 1,691 5% (3)% 3% 5% 5% 5% Yervoy 772 441 1,213 680 413 1,093 14% 7% 11% 14% 14% 14% Reblozyl 641 138 779 334 106 440 92% 30% 77% 92% 32% 78% Opdualag 421 20 441 267 4 271 58% * 63% 58% * 63% Abecma 106 71 177 233 46 279 (55)% 54% (37)% (55)% 61% (35)% Zeposia 183 78 261 124 54 178 48% 44% 47% 48% 44% 47% Breyanzi 209 51 260 141 30 171 48% 70% 52% 48% 77% 53% Camzyos 207 16 223 75 — 75 * N/A * * N/A * Sotyktu 75 22 97 39 2 41 92% * * 92% * * Augtyro 13 — 13 — — — N/A N/A N/A N/A N/A N/A Krazati 50 3 53 — — — N/A N/A N/A N/A N/A N/A Other Growth Products (a) 316 344 660 306 269 575 3% 28% 15% 3% 33% 17% Total Growth Portfolio 6,868 3,520 10,388 5,947 3,214 9,161 15% 10% 13% 15 % 18% 16% Legacy Portfolio Eliquis 5,365 1,771 7,136 4,838 1,789 6,627 11% (1)% 8% 11% —% 8% Revlimid 2,618 404 3,022 2,742 476 3,218 (5)% (15)% (6)% (5)% (11)% (5)% Pomalyst/Imnovid 1,313 511 1,824 1,106 573 1,679 19% (11)% 9% 19% (9)% 9% Sprycel 623 175 798 612 275 887 2% (36)% (10)% 2% (32)% (9)% Abraxane 299 149 448 348 149 497 (14)% —% (10)% (14)% 17% (5)% Other Legacy Products (b) 191 259 450 163 331 494 17% (22)% (9)% 17% (19)% (7)% Total Legacy Portfolio 10,409 3,269 13,678 9,809 3,593 13,402 6% (9)% 2% 6% (6)% 3% Total Revenues $ 17,277 $ 6,789 $ 24,066 $ 15,756 $ 6,807 $ 22,563 10% —% 7% 10% 5% 8% * In excess of +100%. ** See "Use of Non-GAAP Financial Information". (a) Includes Onureg , Inrebic, Nulojix , Empliciti and royalty revenues. (b) Includes other mature brands. (c) Beginning in 2024, Puerto Rico revenues are included in International revenues. Prior period amounts have been reclassified to conform to the current presentation. (d) Worldwide (WW) includes U.S. and International (Int'l). BRISTOL-MYERS SQUIBB COMPANY INTERNATIONAL REVENUES (a) FOREIGN EXCHANGE IMPACT (%) (Unaudited) Three Months Ended June 30, 2024 Six Months Ended June 30, 2024 Revenue Change % F/X % Favorable/ (Unfavorable) ** Revenue Change % Ex- F/X ** Revenue Change % F/X % Favorable/ (Unfavorable) ** Revenue Change % Ex- F/X ** Growth Portfolio Opdivo 6% (12)% 18% 3% (10)% 13% Orencia (11)% (9)% (2)% (3)% (8)% 5% Yervoy 4% (7)% 11% 7% (7)% 14% Reblozyl 38% (3)% 41% 30% (2)% 32% Opdualag * * * * * * Abecma * * * 54% (7)% 61% Zeposia 48% —% 48% 44% —% 44% Breyanzi 82% (12)% 94% 70% (7)% 77% Camzyos N/A N/A N/A N/A N/A N/A Sotyktu * * * * * * Augtyro N/A N/A N/A N/A N/A N/A Krazati N/A N/A N/A N/A N/A N/A Other Growth Products (b) 30% (5)% 35% 28% (5)% 33% Total Growth Portfolio 11% (10)% 21% 10% (8)% 18% Legacy Portfolio Eliquis (2)% (2)% —% (1)% (1)% —% Revlimid (24)% (4)% (20)% (15)% (4)% (11)% Pomalyst/Imnovid (14)% (3)% (11)% (11)% (2)% (9)% Sprycel (39)% (5)% (34)% (36)% (4)% (32)% Abraxane 8% (17)% 25% —% (17)% 17% Other Legacy Products (c) (24)% (5)% (19)% (22)% (3)% (19)% Total Legacy Portfolio (11)% (3)% (8)% (9)% (3)% (6)% Total Revenues (1)% (7)% 6% —% (5)% 5% * In excess of +100%. ** See "Use of Non-GAAP Financial Information". (a) Beginning in 2024, Puerto Rico revenues are included in International revenues. Prior period amounts have been reclassified to conform to the current presentation. (b) Includes Onureg , Nulojix , Empliciti and royalty revenues. (c) Includes other mature brands. BRISTOL-MYERS SQUIBB COMPANY WORLDWIDE REVENUES (a) FOREIGN EXCHANGE IMPACT (%) (Unaudited) Three Months Ended June 30, 2024 Six Months Ended June 30, 2024 Revenue Change % F/X % Favorable/ (Unfavorable) ** Revenue Change % Ex- F/X ** Revenue Change % F/X % Favorable/ (Unfavorable) ** Revenue Change % Ex- F/X ** Growth Portfolio Opdivo 11% (5)% 16% 3% (4)% 7% Orencia 2% (3)% 5% 3% (2)% 5% Yervoy 8% (2)% 10% 11% (3)% 14% Reblozyl 82% —% 82% 77% (1)% 78% Opdualag 53% —% 53% 63% —% 63% Abecma (28)% (1)% (27)% (37)% (2)% (35)% Zeposia 51% —% 51% 47% —% 47% Breyanzi 53% (2)% 55% 52% (1)% 53% Camzyos * * * * * * Sotyktu * * * * * * Augtyro N/A N/A N/A N/A N/A N/A Krazati N/A N/A N/A N/A N/A N/A Other Growth Products (b) 16% (2)% 18% 15% (2)% 17% Total Growth Portfolio 18% (3)% 21% 13% (3)% 16% Legacy Portfolio Eliquis 7% —% 7% 8% —% 8% Revlimid (8)% (1)% (7)% (6)% (1)% (5)% Pomalyst/Imnovid 13% (1)% 14% 9% —% 9% Sprycel (7)% (1)% (6)% (10)% (1)% (9)% Abraxane (10)% (4)% (6)% (10)% (5)% (5)% Other Legacy Products (c) (10)% (2)% (8)% (9)% (2)% (7)% Total Legacy Portfolio 2% (1)% 3% 2% (1)% 3% Total Revenues 9% (2)% 11% 7% (1)% 8% * In excess of +100%. ** See "Use of Non-GAAP Financial Information". (a) Worldwide (WW) includes U.S. and International (Int'l). (b) Includes Onureg , Nulojix , Empliciti and royalty revenues. (c) Includes other mature brands. BRISTOL-MYERS SQUIBB COMPANY RECONCILIATION OF GAAP AND NON-GAAP GROWTH DOLLARS AND PERCENTAGES EXCLUDING FOREIGN EXCHANGE IMPACT * (Unaudited, dollars in millions) THREE MONTHS 2024 2023 Change $ Change % Favorable / (Unfavorable) F/X $ ** 2024 Excl. F/X ** Favorable / (Unfavorable) F/X % ** % Change Excl. F/X ** Revenues $ 12,201 $ 11,226 $ 975 9% $ (224) $ 12,425 (2)% 11% Gross profit 8,934 8,350 584 7% N/A N/A N/A N/A Gross profit excluding specified items (a) 9,230 8,417 813 10% N/A N/A N/A N/A Gross margin (b) 73.2 % 74.4 % Gross margin excluding specified items 75.6 % 75.0 % Marketing, selling and administrative 1,928 1,934 (6 ) —% 31 1,959 1% 1% Marketing, selling and administrative excluding specified items (a) 1,922 1,914 8 —% 31 1,953 2% 2% Research and development 2,899 2,258 641 28% 15 2,914 1% 29% Research and development excluding specified items (a) 2,295 2,252 43 2% 15 2,310 1% 3% Operating margin (c) 33.7 % 37.0 % Operating margin excluding specified items 41.1 % 37.9 % SIX MONTHS 2024 2023 Change $ Change % Favorable / (Unfavorable) F/X $ ** 2024 Excl. F/X ** Favorable / (Unfavorable) F/X % ** % Change Excl. F/X ** Revenues $ 24,066 $ 22,563 $ 1,503 7% $ (377) $ 24,443 (1)% 8% Gross profit 17,867 17,121 746 4% N/A N/A N/A N/A Gross profit excluding specified items (a) 18,185 17,242 943 5% N/A N/A N/A N/A Gross margin (b) 74.2 % 75.9 % Gross margin excluding specified items 75.6 % 76.4 % Marketing, selling and administrative 4,295 3,696 599 16% 52 4,347 2% 18% Marketing, selling and administrative excluding specified items (a) 3,911 3,676 235 6% 52 3,963 2% 8% Research and development 5,594 4,579 1,015 22% 24 5,618 1% 23% Research and development excluding specified items (a) 4,641 4,458 183 4% 24 4,665 1% 5% Operating margin (c) 33.2 % 39.2 % Operating margin excluding specified items 40.0 % 40.4 % * 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 below for further details. (b) Represents gross profit as a percentage of Revenues. (c) Operating margin represents gross profit less marketing, selling and administrative expenses and research and development expenses, as a percentage of Revenues. BRISTOL-MYERS SQUIBB COMPANY SPECIFIED ITEMS (Unaudited, dollars in millions) Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Inventory purchase price accounting adjustments $ 13 $ 31 $ 21 $ 84 Intangible asset impairment 280 — 280 — Site exit and other costs 3 36 17 37 Cost of products sold 296 67 318 121 Acquisition related charges (a) — — 372 — Site exit and other costs 6 20 12 20 Marketing, selling and administrative 6 20 384 20 IPRD impairments 590 — 590 20 Priority review voucher — — — 95 Acquisition related charges (a) — — 348 — Site exit and other costs 14 6 15 6 Research and development 604 6 953 121 Amortization of acquired intangible assets 2,416 2,257 4,773 4,513 Interest expense (b) (12 ) (13 ) (25 ) (27 ) Equity investment (gain)/losses (107 ) 58 (209 ) 208 Acquisition expenses 1 — 50 — Integration expenses 74 59 145 126 Litigation and other settlements 61 — 61 (335 ) Provision for restructuring 260 113 480 180 Other — — 10 (5 ) Other (income)/expense, net 277 217 512 147 Increase to Earnings before income taxes 3,599 2,567 6,940 4,922 Income taxes on items above (585 ) (311 ) (925 ) (604 ) Income tax reserve releases (502 ) — (502 ) — Income taxes attributed to a non-U.S. tax ruling — (656 ) — (656 ) Income taxes (1,087 ) (967 ) (1,427 ) (1,260 ) Increase to net earnings $ 2,512 $ 1,600 $ 5,513 $ 3,662 (a) Includes cash settlement of unvested stock awards, and other related costs incurred in connection with the recent acquisitions of Karuna, RayzeBio and Mirati. (b) Includes amortization of purchase price adjustments to Celgene debt. BRISTOL-MYERS SQUIBB COMPANY RECONCILIATION OF CERTAIN GAAP LINE ITEMS TO CERTAIN NON-GAAP LINE ITEMS (Unaudited, dollars and shares in millions except per share data) Three Months Ended June 30, 2024 Six Months Ended June 30, 2024 GAAP Specified Items (a) Non-GAAP GAAP Specified Items (a) Non-GAAP Gross profit $ 8,934 $ 296 $ 9,230 $ 17,867 $ 318 $ 18,185 Marketing, selling and administrative 1,928 (6 ) 1,922 4,295 (384 ) 3,911 Research and development 2,899 (604 ) 2,295 5,594 (953 ) 4,641 Amortization of acquired intangible assets 2,416 (2,416 ) — 4,773 (4,773 ) — Other (income)/expense, net 273 (277 ) (4 ) 354 (512 ) (158 ) Earnings/(Loss) before income taxes 1,286 3,599 4,885 (10,230 ) 6,940 (3,290 ) Provision for income taxes (398 ) 1,087 689 (6 ) 1,427 1,421 Net earnings/(loss) attributable to BMS used for diluted EPS calculation $ 1,680 $ 2,512 $ 4,192 $ (10,231 ) $ 5,513 $ (4,718 ) Weighted-average common shares outstanding—diluted 2,029 2,029 2,029 2,025 2,025 2,025 Diluted earnings/(loss) per share $ 0.83 $ 1.24 $ 2.07 $ (5.05 ) $ 2.72 $ (2.33 ) Effective tax rate (30.9 )% 45.0 % 14.1 % 0.1 % (43.3 )% (43.2 )% Three Months Ended June 30, 2023 Six Months Ended June 30, 2023 GAAP Specified Items (a) Non-GAAP GAAP Specified Items (a) Non-GAAP Gross profit $ 8,350 $ 67 $ 8,417 $ 17,121 $ 121 $ 17,242 Marketing, selling and administrative 1,934 (20 ) 1,914 3,696 (20 ) 3,676 Research and development 2,258 (6 ) 2,252 4,579 (121 ) 4,458 Amortization of acquired intangible assets 2,257 (2,257 ) — 4,513 (4,513 ) — Other (income)/expense, net (116 ) (217 ) (333 ) (529 ) (147 ) (676 ) Earnings before income taxes 1,859 2,567 4,426 4,629 4,922 9,551 Provision for income taxes (218 ) 967 749 285 1,260 1,545 Net earnings attributable to BMS used for diluted EPS calculation $ 2,073 $ 1,600 $ 3,673 $ 4,335 $ 3,662 $ 7,997 Weighted-average common shares outstanding—diluted 2,102 2,102 2,102 2,107 2,107 2,107 Diluted earnings per share $ 0.99 $ 0.76 $ 1.75 $ 2.06 $ 1.74 $ 3.80 Effective tax rate (11.7 )% 28.6 % 16.9 % 6.2 % 10.0 % 16.2 % (a) Refer to the Specified Items schedule above for further details. Effective tax rate on the Specified Items represents the difference between the GAAP and Non-GAAP effective tax rate. BRISTOL-MYERS SQUIBB COMPANY NET DEBT CALCULATION AS OF JUNE 30, 2024 AND DECEMBER 31, 2023 (Unaudited, dollars in millions) June 30, 2024 December 31, 2023 Cash and cash equivalents $ 6,293 $ 11,464 Marketable debt securities - current 360 816 Marketable debt securities - non-current 357 364 Cash, cash equivalents and marketable debt securities $ 7,010 $ 12,644 Short-term debt obligations (3,531 ) (3,119 ) Long-term debt (48,858 ) (36,653 ) Net debt position $ (45,379 ) $ (27,128 )