Bristol-Myers Squibb Company (BMY) Q3 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call summary shows strong financial performance, increased revenue guidance, strategic partnerships, and promising product developments. The Q&A section supports this with positive updates on Cobenfy's commercial progress and strategic partnerships. Although management avoided some questions, the overall sentiment remains positive due to strong growth outlook and strategic initiatives.
Key Financial Performance
Total company sales Approximately $12.2 billion, reflecting strong demand across the business. Global sales of the growth portfolio increased 17% year-over-year, driven primarily by demand across multiple brands, notably the IO portfolio, Reblozyl, Camzyos, and Breyanzi.
Opdivo global sales Approximately $2.5 billion, up 6% year-over-year. Growth driven by continued demand, strong launch in MSI-high colorectal cancer, and share growth in first-line non-small cell lung cancer.
Reblozyl global sales $615 million, reflecting continued strength across MDS-associated anemia indications. U.S. revenue growth up 38%, driven by demand in first-line RS-positive and RS-negative settings and improved therapy duration. Outside the U.S., sales grew 31%, driven by demand in newly launched markets.
Breyanzi global sales $359 million, annualizing over $1 billion. Global sales grew 58%, reflecting strong demand across all indications. U.S. sales were $251 million, growing 45%, driven by growth in large B-cell lymphoma and new indications. Outside the U.S., sales were $109 million, more than doubling due to demand in existing and newly launched markets.
Camzyos global sales $296 million, up 88% year-over-year, reflecting robust demand. U.S. sales were $238 million, up 76%, driven by increasing new patient starts. Outside the U.S., sales growth more than doubled due to launch momentum in multiple markets.
Eliquis global sales $3.7 billion, growing 23% year-over-year, driven by strong demand and favorable impact of Medicare Part D redesign. U.S. sales grew 29%, and ex-U.S. sales grew 11%.
Sotyktu global sales Grew 20% globally. U.S. sales remained consistent with prior year due to demand being offset by higher rebates associated with increased commercial access.
Cobenfy sales $43 million in the quarter and $105 million year-to-date. Sales and weekly total prescriptions continue to grow steadily.
Gross margin Approximately 73%, primarily due to product mix.
Operating expenses Decreased by approximately $100 million to roughly $4.2 billion compared to the same period last year, primarily reflecting savings from ongoing strategic productivity initiatives.
Cash flow from operations About $6.3 billion in the third quarter, with nearly $17 billion in cash, cash equivalents, and marketable securities as of September 30.
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Operating Highlights
Cobenfy: Steady growth with positive feedback from physicians, indicating a meaningful first indication.
Qvantig: Launch is tracking well.
Iberdomide: Phase III EXCALIBER study showed significant improvement in MRD negativity rates for relapsed/refractory multiple myeloma.
Pumitamig: Phase II data presented; pivotal studies initiated for triple-negative breast cancer, colorectal cancer, and gastric cancer.
CD19 NEX-T: Encouraging data in autoimmune diseases like lupus and scleroderma.
Sotyktu: Long-term extension data validates potential in lupus.
Iza-bren: Received breakthrough therapy designation for advanced EGFR-mutated non-small cell lung cancer.
Anti-tau antibody: Granted Fast Track designation for Alzheimer's disease treatment.
Orbital Therapeutics acquisition: Strengthens cell therapy franchise with potential off-the-shelf CAR-T asset OTX-201 and RNA technology platform.
PhiloChem licensing agreement: Exclusive worldwide rights to Onco-ACP3, a potential breakthrough treatment for prostate cancer.
SystImmune partnership: First patient treated in global Phase II/III trial of iza-bren for triple-negative breast cancer.
Cost structure alignment: Ongoing strategic productivity initiatives saved $1 billion in 2025.
Digital technology and AI integration: Efforts to enhance operational efficiency and agility.
Data-rich period: Anticipating data readouts for 7 new molecular entities and 7 life cycle management opportunities in the next 12-24 months.
Long-term growth strategy: Plan to introduce 10 new medicines and 30 life cycle management opportunities by the end of the decade.
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Risk or Challenges
Regulatory and Clinical Risks: The company faces potential challenges in obtaining regulatory approvals for its pipeline drugs, as evidenced by the need for positive outcomes in at least two out of three studies for Cobenfy to support regulatory approval. Additionally, the reliance on pivotal readouts and clinical trial results, such as the Phase III EXCALIBER study and others, introduces uncertainty.
Pipeline and R&D Challenges: The company is heavily reliant on its pipeline for future growth, with plans to introduce 10 new medicines and 30 life cycle management opportunities by the end of the decade. Any delays or failures in clinical trials or regulatory processes could significantly impact its growth trajectory.
Market and Competitive Pressures: The company is working to disrupt entrenched prescribing behaviors, such as with Cobenfy, which may face resistance from physicians accustomed to existing treatments. Additionally, competitive pressures in oncology and other therapeutic areas could impact market share and revenue growth.
Supply Chain and Manufacturing Risks: The company’s reliance on a U.S. manufacturing hub for radiopharmaceutical therapies, which have a short shelf life, introduces logistical and operational risks. Any disruptions in this supply chain could impact the timely delivery of treatments.
Financial Risks: The company is managing a significant debt load, with $6.7 billion of a $10 billion debt paydown commitment still outstanding. Additionally, the financial impact of acquired in-process R&D charges and licensing income could affect profitability.
Economic and Operational Risks: The company is undergoing cost restructuring and integrating digital technology and AI to enhance efficiency. However, these initiatives carry execution risks and may not deliver the anticipated efficiencies or agility.
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Guidance & Outlook
Revenue Guidance: The company has increased its full-year revenue guidance by $750 million at the midpoint to a range of $47.5 billion to $48 billion, reflecting strong performance of the growth portfolio.
Legacy Portfolio Decline: The legacy portfolio is expected to decline approximately 15% to 17% for the year, with Revlimid sales expected to remain at approximately $3 billion.
Gross Margin: Gross margin guidance for the year remains unchanged at approximately 72%.
Operating Expenses: Operating expense guidance remains unchanged at approximately $16.5 billion, reflecting over $1 billion in net savings versus 2024.
OI&E (Other Income and Expense): Annual income is now expected to be approximately $500 million due to higher-than-anticipated royalties, licensing income, and favorable interest income.
Tax Guidance: Full-year tax guidance remains at approximately 18%.
EPS Guidance: The expected EPS range for 2025 has been narrowed to $6.40 to $6.60, with the midpoint unchanged.
Growth Portfolio Performance: The growth portfolio is expected to continue driving strong demand, with products like Opdivo, Reblozyl, Camzyos, and Breyanzi showing robust growth.
Future Data Readouts: The company anticipates data readouts for ADEPT-2 by the end of the year and two additional Cobenfy studies in Alzheimer's disease psychosis next year. Over the next 12 to 24 months, data for 7 new molecular entities and 7 life cycle management opportunities are expected.
Long-Term Growth Potential: By the end of the decade, the company aims to introduce 10 new medicines to the market and at least 30 significant life cycle management opportunities.
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Shareholder Return Plan
Dividend Commitment: We remain committed to returning capital to our shareholders through the dividend.
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Key Q&A
Q:Can you provide updates on ADEPT-2 and the broader ADEPT program, including ADEPT-1 and ADEPT-4?
A:ADEPT-2 is an ongoing study with results expected by the end of the year. The company remains confident in the Cobenfy development program, supported by external data, real-world experiences, and internal data from ADEPT-1 and ADEPT-3. ADEPT-4 is similar to ADEPT-2, targeting the same patient population and primary endpoint, with results expected next year. ADEPT-1 differs as it is a relapse prevention design.
Q:How is the commercial progress of Cobenfy in the U.S., and what are the priorities for its development?
A:Cobenfy has surpassed 2,400 TRxs weekly, with positive physician feedback and nearly 100% access across Medicare and Medicaid. The company aims to increase prescribing breadth and depth, supported by an expanded field force and upcoming indications. Cristian Massacesi emphasized prioritizing science, execution, and value in development, integrating new tools like AI, and building strong teams.
Q:What is the competitive landscape for the PD-L1/VEGF bispecific and its implications for the BioNTech partnership?
A:The partnership with BioNTech is strong, and the company believes pumitamig has the potential to become a new standard of care. Multiple trials are ongoing across solid tumor indications, with a focus on speed to market and combining pumitamig with novel treatments. The company is confident in its ability to compete effectively.
Q:What are the barriers to adoption for Cobenfy, and how is the company addressing them?
A:Barriers include prescriber inertia and questions about switching from D2 blockers to Cobenfy. The company is addressing these through peer-to-peer activities, real-world data, and a Phase IV switch study. Feedback from physicians and patients has been positive, and the company is tracking ahead of recently launched analogs in schizophrenia.
Q:What are the cost management strategies and margin trajectory for the company, considering R&D expenses and productivity initiatives?
A:The company is balancing investments in growth areas with disciplined cost management. It is on track to achieve $1 billion in savings this year and $2 billion by 2027. Numerous Phase III programs are completing, and the company has reduced its cost base from $17.8 billion in 2024 to $16.5 billion in 2025. Financial discipline is enabling flexibility for business development and growth.
Q:What are the company's views on the competitive data for VEGF-PD-1 and its development strategy?
A:The company is encouraged by the PFS data and believes it will translate into a survival benefit. The strategy includes becoming the new standard of care in indications like non-small cell lung cancer and expanding into areas where PD-1/PD-L1s have not shown activity, such as MSS CRC. The company is also exploring novel combinations with pumitamig.
Q:What is the company's perspective on trough earnings and the timing of reaching them?
A:The company has not provided specific guidance on trough earnings but aims to make the trough as shallow and short as possible. It anticipates exiting the decade with growth, supported by strong commercial performance, a robust late-stage pipeline, and financial flexibility for business development.
Q:What are the company's thoughts on the IRA negotiations and their impact on Pomalyst?
A:The IRA negotiations for Pomalyst are concluding, with the price to be made public by November 30. The company does not expect the negotiations to impact its outlook, as Pomalyst will have lost exclusivity in the U.S. by the time the MSP is effectuated in January 2027.
Q:What are the company's plans for milvexian and its competitive positioning?
A:Milvexian is being developed as a next-generation Factor XIa anticoagulant, with potential applications in atrial fibrillation, ACS, and SSP. The company is confident in its dosing strategy and believes it can provide a superior profile in SSP. All three Phase III studies are expected to read out in 2026.
Q:What are the company's views on iberdomide and its potential for regulatory approval?
A:Iberdomide has shown positive outcomes in MRD negativity rate, and the company is discussing the data with regulatory agencies to determine if it can grant accelerated or conditional approval. The company is confident in the data and will provide updates on the next steps.
Q:Review of Unclear Management Responses
A:Management avoided directly addressing questions about why ADEPT-2 data has not been locked yet and whether additional patients were added to sites. They also did not provide specific details on the IRA negotiations for Pomalyst or the potential impact of CMMI pilots for Medicare.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
AFib
CD NEX
Chief
III trial
Officer
Opdivo sale
Orbital
Phase II
Phase III
PhiloChem asset
RD
RNA
RYZ
Slide sale
Sotyktu
SystImmune milestone
Therapeutics
agreement PhiloChem
asset license
breakthrough
cycle opportunity
degradation platform
demand sale
designation
discipline
income PhiloChem
indication sale
license SystImmune
licensing agreement
licensing income
life cycle
line cancer
lupus
midpoint
protein degradation
pumitamig
shelf
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