10-K: Bristol-Myers Squibb Reports Mixed 2024 Results Amid Strategic Acquisitions and Evolving Market Dynamics

• Bristol-Myers Squibb (BMS) reported a 7% increase in total revenues, reaching $48.3 billion in 2024, compared to $45.0 billion in 2023.
• The revenue growth was primarily fueled by the Growth Portfolio and Eliquis, but partially offset by generic erosion in the Legacy Portfolio.
• GAAP diluted loss per share was $(4.41), a decrease of $8.27, while non-GAAP EPS was $1.15, a decrease of $6.36.
• The GAAP EPS decrease was largely due to a one-time, non-deductible Acquired IPRD charge from the Karuna acquisition and SystImmune collaboration, impacting EPS by approximately $6.28.
• BMS completed acquisitions of Karuna, RayzeBio, and Mirati in 2024, expanding its presence in neuroscience and oncology.
• R&D expenses increased to $11.2 billion, while Acquired IPRD expenses surged to $13.4 billion, including $12.1 billion related to the Karuna acquisition.
• The company anticipates continued generic erosion within its Legacy Portfolio in 2025, mainly due to Revlimid, Sprycel, and Pomalyst outside the U.S.
• BMS expects to realize approximately $2.0 billion in additional annual cost savings by the end of 2027 through a strategic productivity initiative.

Score: 5

Explanation: The document presents a mixed sentiment. While there's revenue growth and strategic acquisitions, the significant IPRD expenses and GAAP loss per share temper the overall outlook. The company faces challenges related to pricing pressures and generic competition.

• Revenue growth of 7% driven by the Growth Portfolio and Eliquis.
• Strategic acquisitions of Karuna, RayzeBio, and Mirati expand therapeutic focus.
• Approvals for Breyanzi in the U.S. and Japan for adults with relapsed or refractory FL and in the U.S. for adults with relapsed or refractory CLL/SLL and MCL.
• Reblozyl's expanded approval to include the first-line treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk MDS in the EU and Japan.
• FDA approval of Opdivo Qvantig injection for subcutaneous use in most previously approved adult solid tumor Opdivo indications.
• FDA approval of Opdivo for the treatment of adult patients with resectable NSCLC, in combination with platinum-doublet chemotherapy, followed by single-agent Opdivo as adjuvant treatment after surgery.
• FDA approval and subsequent launch of Cobenfy for the treatment of schizophrenia in adults.

• GAAP diluted loss per share of $(4.41).
• Non-GAAP EPS decreased by $6.36.
• Significant Acquired IPRD expenses impacted profitability.
• Anticipated continued generic erosion within the Legacy Portfolio in 2025.
• Intangible asset impairment charges of $2.9 billion.

• Increased pricing pressure and restrictions in the U.S. and abroad could negatively affect revenues and profit margins.
• Difficulties or delays in the development and commercialization of new products could impact revenue.
• Loss of market exclusivity of a product earlier than expected could lead to rapid revenue declines.
• Intense competition from other biopharmaceutical companies and manufacturers could erode market share.
• Difficulties, delays, and disruptions in the supply chain and manufacturing could impact product availability.
• Litigation claiming infringement of intellectual property may adversely affect future revenues and operating earnings.
• Cybersecurity incidents could disrupt business and result in theft of proprietary information.
• Failure to attract and retain a highly qualified workforce could affect the ability to develop and commercialize products.
• Adverse changes in U.S. and global economic and political conditions could adversely affect operations and profitability.

BMS expects continued generic erosion within its Legacy Portfolio in 2025 and anticipates a number of registrational data readouts with the potential to deliver 10 or more new medicines and multiple additional indications over the next five years.

• Management continues to emphasize leadership, innovation, productivity and quality as strategies for success in our R&D activities.

The pharmaceutical industry is facing increasing pricing pressures and regulatory scrutiny, particularly in the U.S. and Europe. The IRA is expected to have a significant impact on drug pricing and reimbursement, potentially reducing revenues for pharmaceutical companies. Competition from generic and biosimilar manufacturers is also intensifying, leading to revenue erosion for branded products.

• The R&D failure rates cited from the KMR Group (93% for small molecules in Phase I, 81% in Phase II, 33% in Phase III; 89% for biologics in Phase I, 72% in Phase II, 23% in Phase III) provide a benchmark for assessing BMS's R&D efficiency.
• Comparable companies such as AbbVie, Amgen, Johnson & Johnson, and Merck are also facing similar challenges related to pricing pressures, patent expirations, and competition from generics and biosimilars.
• The growth and consolidation of MCOs and PBMs in the U.S., such as Optum (UHC), CVS Health (CVS) and Express Scripts (ESI), has also been a major factor in the healthcare marketplace.
• The company's success in having its major products included on MCO and PBM formularies is an important factor in its competitive position.

• Shareholders: Impacted by financial performance, strategic decisions, and dividend payouts.
• Employees: Affected by restructuring initiatives, compensation, and benefits.
• Patients: Benefit from the discovery, development, and delivery of innovative medicines.
• Customers: Impacted by pricing, market access, and product availability.
• Suppliers: Subject to supply chain management and contractual obligations.
• Creditors: Impacted by the company's debt levels and credit ratings.

• Continue to evaluate the impact of the IRA on results of operations.
• Advance late-stage pipeline programs.
• Execute launches of newly approved products.
• Manage change from operating model evolution.
• Manage costs effectively.

• BMS is involved in patent litigation throughout Europe against companies seeking to launch generic apixaban products prior to the expiration of the composition-of-matter patent for Eliquis and its associated SPCs.
• BMS and certain Sanofi entities are defendants in a consumer protection action brought by the attorney general of Hawaii relating to the labeling, sales and/or promotion of Plavix *.
• In December 2024, Celgene received a Notice Letter from Cipla USA, Inc. (Cipla) notifying Celgene that Cipla had filed an ANDA containing paragraph IV certifications seeking approval to market generic pomalidomide products in the U.S.
• In October 2021, Actelion Pharmaceuticals LTD and Actelion Pharmaceuticals US, INC (Actelion) filed a complaint for patent infringement in the United States District Court for the District of New Jersey against BMS and Celgene for alleged infringement of U.S. Patent No. 10,251,867 (the 867 Patent).
• In May and June 2024, BMS received Notice Letters from Synthon BV (Synthon) and Apotex Inc. (Apotex), respectively, each notifying BMS that it has filed an ANDA containing a paragraph IV certification seeking approval of a generic version of Zeposia in the U.S. and challenging a polymorph patent listed in the Orange Book for Zeposia but not the composition of matter patent.
• In June 2021, an action was filed against BMS in the U.S. District Court for the Southern District of New York asserting claims of alleged breaches of a Contingent Value Rights Agreement (CVR Agreement) entered into in connection with the closing of BMSs acquisition of Celgene in November 2019.
• Former Celgene stockholders have filed complaints in the U.S. District Court for the Southern District of New York asserting claims on behalf of a putative class of Celgene stockholders who received CVRs in the BMS merger with Celgene for violations of the securities laws relating to the joint proxy statement.
• In November 2021, an alleged Celgene stockholder filed a complaint in the Superior Court of New Jersey, Union County, asserting claims on behalf of two separate putative classes, one of acquirers of CVRs and one of acquirers of BMS common stock, for violations of securities laws.
• On June 16, 2023, BMS filed a lawsuit against the U.S. Department of Health & Human Services and the Centers for Medicare & Medicaid Services, et al., challenging the constitutionality of the drug-pricing program in the IRA.
• On November 26, 2024, BMS filed a lawsuit against Carole Johnson, Administrator of Health Resources & Services Administration (HRSA) and Xavier Becerra, U.S. Secretary of Health & Human Services, challenging HRSAs determination that BMS could not implement a cash rebate model for the 340B drug pricing program.
• Beginning in November 2014, putative class action lawsuits were filed against Celgene in the U.S. District Court for the District of New Jersey alleging that Celgene violated various antitrust, consumer protection, and unfair competition laws in connection with, among other things, activities related to obtaining and litigating certain Revlimid patents.
• Beginning in September 2023, certain entities filed putative class actions against Celgene, BMS, and certain individuals in the U.S. District Court for the Southern District of New York asserting claims under various antitrust, consumer protection, and unjust enrichment laws in connection with activities related to obtaining and litigating certain Pomalyst patents.

• August 1933: Bristol-Myers Squibb Company was incorporated in Delaware.
• 1989: Bristol-Myers Company changed its name to Bristol-Myers Squibb Company as a result of a merger.
• August 16, 2022: President Biden signed the Inflation Reduction Act (IRA) into law.
• January 18, 2022: Generic entry for Revlimid in the UK began.
• February 18, 2022: Generic entry for Revlimid in various other European countries began.
• March 4, 2022: FDA approved Opdivo given with three cycles of platinum-doublet chemotherapy for the first-line treatment of adult patients with resectable NSCLC in the neoadjuvant setting.
• January 1, 2024: Royalties related to Keytruda decreased from 6.5% to 2.5%.
• January 1, 2024: The American Rescue Plan Act of 2021 eliminated the Medicaid Prescription Drug Rebate cap.
• January 23, 2024: BMS acquired Mirati Therapeutics.
• February 26, 2024: BMS acquired RayzeBio.
• March 18, 2024: BMS acquired Karuna Therapeutics.
• August 2024: HHS announced the 'maximum fair price' for Eliquis under the IRA.
• September 26, 2024: FDA approved Cobenfy for the treatment of schizophrenia in adults.
• January 2025: HHS selected Pomalyst as a medicine subject to 'negotiation' for government-set prices beginning in 2027.
• January 31, 2026: Volume limits on generic lenalidomide licenses in the U.S. will be removed.
• January 1, 2026: The 'maximum fair price' for Eliquis applies to the U.S. Medicare channel.
• December 31, 2026: Royalties related to Keytruda and Tecentriq are expected to terminate.
• December 31, 2025: Royalties from divested diabetes business terminate.
• January 2027: HHS selected Pomalyst as a medicine subject to 'negotiation' for government-set prices beginning.