The paragraph is an introduction to the Bristol-Myers Squibb Company's First Quarter 2025 Earnings Conference Call. It states that the call will initially be in a listen-only mode, followed by a Q&A session, and is being recorded. Chuck Triano, the Senior Vice President and Head of Investor Relations, introduces himself and other key executives, including Christopher Boerner, David Elkins, Adam Lenkowsky, and Samit Hirawat, who will present prepared remarks. A slide presentation has been posted on the company's website to accompany the remarks. The call will include forward-looking statements, with a disclaimer that actual results may vary due to various factors. Non-GAAP financial measures will be used, with reconciliations available on the website.

The paragraph highlights the company's strong first-quarter performance, driven by effective execution, strategic priorities, and a focus on long-term growth. Key areas of focus include maximizing the growth portfolio, accelerating the R&D pipeline, and optimizing operations. The company's growth portfolio experienced double-digit sales growth, led by key products such as Breyanzi, Reblozyl, and Camzyos. The legacy portfolio was affected by generic competition. Recent product launches include Cobenefit, a new treatment for schizophrenia with positive feedback on its tolerability and efficacy, and OpdivoCuvanti, a subcutaneous formulation of nivolumab, also receiving positive early feedback.

In the third paragraph, the company reports an increase in its financial guidance due to strong first-quarter performance and ongoing advancements in its product pipeline. Notably, Opdivo plus Yervoy has gained approvals for liver and colorectal cancer treatments, Breyanzi for follicular lymphoma in the EU, and Camzyos in Japan with an updated US label. Milvexian's trial enrollment for atrial fibrillation is complete, with results expected by 2027. The company also addresses the Camzyos and Cobenfi studies, which did not meet primary endpoints but do not significantly alter their strategic direction or growth. Despite disappointing results in specific studies, confidence remains in existing market opportunities and the potential for Camzyos in treating obstructive HCM and Cobenfi in adjunctive schizophrenia, highlighting encouraging improvements and a safe profile.

The paragraph outlines the company's plans and ongoing initiatives across multiple therapeutic areas. They are evaluating phase three trial data for Cobenfi, aiming to establish it as a primary treatment for schizophrenia, given the lack of approved adjunctive therapies. Cobenfi is also in trials for Alzheimer's disease psychosis, with further phase three studies planned for Alzheimer's agitation, cognition impairment, and bipolar one. In oncology, they are advancing studies for Isobren in triple-negative breast cancer and an androgen receptor degrader in prostate cancer. Additionally, they're expanding trials for glaukatomide in lymphoma, focusing on chemo-free regimens. These efforts target significant unmet medical needs, expected to offer substantial opportunities later in the decade.

The paragraph discusses the company's focus on enhancing its growth portfolio through pivotal data outcomes and innovation in medicine, emphasizing internal discovery and strategic business development. It highlights the company's strong financial position and organizational agility, enabling decisive action on growth opportunities. The company is actively working to optimize cost structures for efficiency while advancing its pipeline and delivering strong execution for top-tier growth by the decade's end. Despite global uncertainties like tariffs and potential economic downturns, the company remains dedicated to building resilience and delivering results for patients, employees, and shareholders. Their strategy is clear, with an emphasis on execution and seizing opportunities.

David Elkins, in an update on the company's performance in the first quarter of 2025, highlighted a strong start driven by their growth strategy focused on revenue generation and cost management. Total revenues reached approximately $11.2 billion, driven by strong demand in the growth portfolio, including the launch of Cobenfi, despite challenges from generics and Medicare Part D changes in their legacy portfolio. The growth portfolio saw an 18% increase in global sales, with key brands like their IO portfolio, Breyanzi, Reblozyl, and Camzyos leading the way. Opdivo's global revenue increased by 12%, aided by volume growth, and the U.S. launch of Opdivo plus Kuventig showed promising initial sales. Reblozyl continued to perform well, particularly in the U.S. and newly launched markets in Europe and Japan. Breyanzi contributed significantly to growth, with U.S. sales more than doubling and international sales tripling.

In the first quarter, the company saw significant growth in sales, with Camzyos experiencing strong demand due to its efficacy and safety profile, although Eliquis sales declined by 3% due to Medicare Part D redesign. The immunology portfolio also saw demand growth despite higher commercial rebates. Cobenfi had a strong market entry, recording $27 million in sales. The company reported a gross margin of 73%, reduced operating expenses by over $500 million, and an effective tax rate of 15.1%, resulting in diluted earnings per share of $1.80. They maintain a robust financial position with $12.1 billion in cash and marketable securities.

In the first quarter, the company generated $2 billion in cash flow from operations and continues to focus on strategic capital allocation. They aim to pay down $10 billion of debt by March 2024 while maintaining dividend payments for the 93rd consecutive year in 2025. The company is also implementing a strategic productivity initiative to achieve $2 billion in annual cost savings by 2027, with $1 billion expected by the end of the current year. Their revenue guidance has increased to $45.8 billion to $46.8 billion for the full year, driven by strong growth portfolio performance, better-than-expected legacy sales, and favorable foreign exchange impacts. The legacy portfolio is projected to decline 16% to 18%, mainly due to Revlimid's strong Q1 performance, with projected sales at the top of the $2 billion to $2.5 billion range. Gross margin guidance remains at 72%, and operating expenses are expected to be around $16 billion, with an additional $200 million impact from foreign exchange rates.

The company anticipates higher expenses in the second half of the year due to investment timing but maintains its operating margin target of approximately 37% for the year. Annual income expectations for OI and E are set at around $100 million, thanks to higher royalties and favorable interest income. Although the first-quarter tax rate was slightly lower, the full-year guidance remains at 18%. The 2025 non-GAAP EPS guidance midpoint is raised by 15¢ per share, ranging from $6.70 to $7, considering current tariffs on US products to China but excluding potential pharmaceutical sector tariffs. The strong first-quarter performance highlights disciplined execution, positioning the company well to handle macro-environment uncertainties and advance its growth strategy. The paragraph ends with an introduction to a Q&A session with Chuck Triano and Christopher Schott from JPMorgan.

The paragraph features a discussion led by Christopher Boerner about the impact of tariffs and trade policies on the pharmaceutical sector, particularly focusing on US-based companies like Bristol-Myers Squibb. Boerner expresses appreciation for the efforts to enhance US manufacturing but emphasizes the need for thoughtful implementation to boost competitiveness. He notes that the impact of tariffs, especially those involving China, has been incorporated into the company's guidance, with further specifics awaited. Adam Lenkowsky then addresses the sales impact of Cobenfi, indicating that current data is not expected to significantly influence sales as most patients are treated with monotherapy. The company is focused on positioning Cobenfi as an earlier treatment option in the market.

The paragraph discusses the current market performance and strategic plans for Cobenfi, a medication for schizophrenia. Despite not achieving a particular study endpoint, Cobenfi's safety and efficacy have led to strong uptake as both a second-line and third-line therapy. Positive feedback from physicians and patients supports its market success. The company plans to continue promoting Cobenfi as a foundational monotherapy treatment to drive growth. In the subsequent exchange, Mohit Bansal from Wells Fargo asks about the company's research and development strategy in light of recent cost rationalization and setbacks. Christopher Boerner responds, highlighting the focus on strong execution across the enterprise, with Samit expected to provide further insights on R&D efforts.

The paragraph discusses the organization's efforts to enhance efficiency and agility, such as cost optimization and a $2 billion initiative. Despite recent studies not meeting expectations, there's confidence in the company's growth prospects fueled by its R&D pipeline. The focus remains on delivering new opportunities, investing in promising science, and leveraging a strong financial position for strategic innovation. Samit Hirawat adds that over the past five years, the company has achieved 43 major approvals, highlighting its high productivity.

The paragraph discusses the research and development plans of a company, focusing on their goal to introduce over 10 new molecular entities and more than 30 new indications by the end of the decade. A specific opportunity in myelofibrosis is expected to have results later this year, alongside eagerly anticipated developments like ADAPT. A significant number of readouts for new molecules are scheduled for 2026 as the company seeks to expand its portfolio. In a Q&A section, Luisa Hector asks about Cobenfi and its relation to Alzheimer's psychosis trials. Samit Hirawat responds that the ARISE data does not affect their confidence in these trials due to differences in disease and existing supportive data on zenomeline.

The paragraph discusses several topics related to the pharmaceutical industry. It mentions that a longer treatment duration in Alzheimer's disease psychosis studies is beneficial for observing primary and secondary endpoints. The speaker feels confident in the conduct of their studies and anticipates starting several Phase III trials. Christopher Boerner addresses a question from Geoffrey Meacham about tariffs, highlighting the complexity and global nature of pharmaceutical supply chains, and the uncertainties regarding the impact of potential industry tariffs. He emphasizes the consideration the administration is giving to study the matter and comments on the complexity of manufacturing processes. The paragraph also briefly touches on business development strategies, including recent deals involving Chinese assets and the valuation of US SMID biotech companies.

The paragraph discusses Bristol-Myers Squibb Company's strategy to mitigate potential tariff impacts on its critical medicines, highlighting their global and flexible manufacturing network that reduces reliance on any single country. They emphasize their ongoing efforts in onshoring and risk reduction to prevent disruptions and shortages. The company is actively engaging with the administration to influence tariff-related decisions and underscores business development as a top priority, focusing on partnerships and acquisitions.

The paragraph features a discussion during an earnings call or a similar corporate event. It starts with a speaker, possibly a corporate executive, addressing the company's strategy to source innovation globally, with a significant focus on refining their position in key therapeutic areas. They emphasize selecting science assets that enhance growth and are financially viable, ultimately benefiting the company and its shareholders. After this, Evan Seigerman from BMO Capital poses questions related to potential policy changes concerning drug pricing negotiations under the Inflation Reduction Act (IRA), particularly regarding the "most favored nation's" pricing. Christopher Boerner responds by acknowledging the focus on international pricing differences and suggests there is consideration of both US and international pricing in their strategy, indicating some alignment with the administration's perspective.

The paragraph discusses Bristol-Myers Squibb Company's efforts to encourage countries outside the US to increase healthcare spending on innovative medicines. It highlights the complexity of the US healthcare system, where a significant portion of pharmaceutical spending goes to middlemen who impact patient costs. The company focuses on addressing healthcare system issues, such as the IRA's pill penalty and the 340B program abuses. Additionally, Bristol-Myers Squibb reports strong growth in sales of Camzyos, with a significant increase from the previous year and a label change reflecting FDA confidence in the medication's safety and efficacy, with over 15,000 US prescriptions.

The label for Camzyos has been updated to allow echo monitoring for patients to occur once every six months instead of every twelve weeks during the maintenance phase. This change simplifies processes for both patients and physicians, opens up capacity at Centers of Excellence (COEs), and allows physicians to treat more patients. Early feedback on the label change is positive, contributing to the strong growth momentum for Camzyos. In the subsequent Q&A, Terence Flynn from Morgan Stanley asked about the Cobenfi launch. Adam Lenkowsky reported a strong start with over 1,600 total prescriptions per week, surpassing benchmarks for branded schizophrenia treatments, and achieving good Medicaid and Medicare access.

The paragraph discusses the progress and strategy for the drug Cobenfi, which now has nearly 100% access across channels and is making headway with commercial payers. This access allows the drug to be used earlier in treatment, which is crucial. Feedback from patients and physicians is positive, highlighting improvements in various symptoms and cognition. The company is seeing consistent growth in new trials since the launch and plans to target 30,000 psychiatrists to boost uptake, particularly in the latter half of 2025. Financially, they reported $27 million in net sales for the quarter, with a $9 million gross-to-net benefit, indicating strong demand. They anticipate increased gross-to-net for the full year but won't provide guidance for 2026.

The paragraph discusses the financial strategy and priorities of a company, emphasizing financial discipline through strategic productivity initiatives that aim to save $1 billion this year and $2 billion by 2027. The company is leveraging AI and automation for efficiency and continually assesses its portfolio for prioritization. Despite focusing on managing the business, the company also plans to invest in long-term growth by strengthening its portfolio and acquiring new assets. The speaker reassures that the company's cash position is robust and business development remains a priority. Following this, there is a shift to a Q&A session where Trung Huynh from UBS asks about expectations for an Alzheimer's psychosis trial related to Camzyos and seeks clarification regarding the gross-to-net percentages and potential rebate strategies.

In the article paragraph, Christopher Boerner introduces the response to a question about Cobenfi to Samit Hirawat, who explains that the trials are compared to placebo and aim to show statistical significance in improving NCI hallucinations and delusions. He highlights that improvements are considered positive since no drugs are currently approved for this condition, pointing to prior studies of zenomeline showing improvements in symptoms and cognition. Results from the first trial are expected later in the year. Adam Lenkowsky discusses growth, stating they don't share specific discounting rates but mention disciplined spending, which positively impacted projections. He notes an expected increase in gross-to-nets due to expanded access in Medicaid and Medicare. Chuck Triano then moves to the next question from Courtney Breen, who inquires about companies' capital investments in US manufacturing and R&D in response to tariffs.

The paragraph discusses Bristol's strategic focus on capital expenditure and business development. Bristol has been investing in core infrastructure in the U.S., including R&D, technology, and capital expenditures, and plans to continue this investment. They hope that trade policies will enhance the sector and support the competitiveness of U.S. companies. Business development is a capital priority, with a focus on sourcing new science and innovation, rather than being directly tied to the success rates of their internal projects like Milvexian and Cobenfi trials.

In the discussion, Chris reflects on their strategic focus over the past eighteen months, emphasizing successful deal integration and the strong launch of Cobenfi. Looking forward, the company sees no internal constraints on executing business development, intending to focus on promising science and areas that can enhance future growth, with the financial capacity to act swiftly. Timothy Anderson from Bank of America asks about long-term guidance that was previously withdrawn and seeks assurance that shares won't fall below $6, touching on transfer pricing arrangements Bristol might have in Europe. Christopher Boerner acknowledges these questions.

The paragraph primarily addresses the company's approach to providing guidance and its strategy for sustained growth. It begins by stating that long-term guidance will not be given as standard, focusing instead on annual guidance with updates as necessary. The company aims to sustain top-tier growth through measures such as accelerating internal clinical programs and business development, with a goal to mitigate any downturns and return to growth by the decade's end. In a shift to transfer pricing, David Elkins explains that it is governed by tax laws in the US and other jurisdictions, dismissing concerns about tariffs.

The paragraph features a conversation during a conference call, where David Risinger from Leerink Partners asks two questions. The first question concerns how Bristol's leadership is engaging with Washington amid perceived threats to the biopharma industry, such as government actions harming innovation, tariff threats, and attempts to lower drug prices. The second question addresses the disappointing results of the Cobenfi adjunctive trial, particularly in the risperidone subgroup, and whether drug-drug interactions (DDIs) might have affected efficacy. Christopher Boerner and Samit Hirawat respond, with Samit indicating they are evaluating the data concerning risperidone and its interaction pathways.

The paragraph discusses the ongoing efforts in a clinical trial, emphasizing the need to explore additional endpoints and collaborate with regulators and physicians. Christopher Boerner stresses the significance of the robust biopharmaceutical ecosystem in the United States, which fosters innovation and ensures rapid access to new medicines. He highlights the importance of government support, clear regulatory frameworks, and a strong intellectual property system in maintaining this environment. Despite changes in Washington, their business remains unaffected, and they plan to keep investing in promising scientific areas and engaging with the government on issues related to pricing and payment for innovation.

The paragraph discusses Bristol-Myers Squibb's focus areas, mentioning the need to address issues related to the Inflation Reduction Act (IRA), such as the pill penalty and spillover risks, and simplifying the U.S. ecosystem by addressing the role of middlemen. The company also aims to encourage more healthcare funding for innovative medicines globally. Additionally, Carter Gould from Cantor asks about the impact of external factors like tariffs and FDA regulations on drug pricing and business development. Christopher Boerner responds, explaining their strategy of maintaining a strong financial position by improving efficiency and agility, which enhances their business development capabilities.

The paragraph features a conversation involving Chris, Chuck Triano, and questions from Steve Scala directed at Samit Hirawat regarding business development and regulatory paths for Bristol's projects. Chris emphasizes the importance of business development and maintaining a disciplined focus on opportunities that align with the company's growth. Steve Scala asks Samit if there is a regulatory path based on ARISE data and about the impact of a competitor's trial stoppage on their Milvexian Phase III trial. Samit responds that they cannot speculate on ARISE's regulatory path as further data analysis is needed, and updates are not provided for Milvexian as the atrial fibrillation trial's event rate remains low, so the timelines haven't been adjusted.

The paragraph outlines ongoing collaborations and updates regarding clinical trials and product growth. It confirms that J&J, along with another party, is set to continue their partnership, with significant trial readouts expected in 2026 and 2027, and enrollment for another trial already completed. The company is seeing strong growth with its product Camzyos, boasting high persistency and an expanding prescriber and patient base. Efforts are focused on increasing prescriptions at Centers of Excellence and expanding into the wider cardiology community, with positive growth trends noted. There are also questions about the defensibility of Camzyos’s market position and its implications for related drug development efforts.

The paragraph discusses competition in the medical field, specifically related to new drugs and treatments. The speaker, Samit Hirawat, addresses the results of the NHCM study and its implications for HFpEF (Heart Failure with preserved Ejection Fraction) in relation to MYK-224. Despite initial hopes, changes in biomarkers did not translate into clinical benefits in the NHCM study. However, these biomarkers have historically tracked well in other HFpEF trials, suggesting potential future benefits. The speaker states it's too early to draw conclusions about the HFpEF program, as further Phase 2a and 2b studies are underway. They also mention the need to prepare for the introduction of the drug aducanthix to the market, maintaining confidence in their leadership position despite competition.

In response to a question from Hassan Hayder about the company's renewed focus on business development (BD) amid industry challenges, Christopher Boerner emphasizes that their capital allocation priorities remain unchanged, with business development being a top priority. The company focuses on strengthening key areas, improving growth profiles, and evaluates opportunities based on certain criteria rather than size. These criteria include strengthening existing therapeutic areas, financial viability, their ability to add scientific value, and improving the company's growth prospects toward the end of the decade and into the 2030s.

In the paragraph, company representatives discuss the progress and adoption of their drugs, particularly Keviantic, in the market. They note that the majority of its use has been in community settings, constituting about 80%, and are working to expand its prescription in both community and academic settings. The adoption of Opdivo plus Yervantes across multiple tumor types is on track with expectations, although reimbursement timing is currently affected due to a temporary J code. A permanent J code is expected by July 1, which should improve the situation in the latter half of the year. They also briefly touch on the market opportunity for MF and express satisfaction with the drug's early performance following its launch.

The paragraph discusses the commercial opportunities and strategies for Reblozyl in treating myelofibrosis and associated anemia. The primary focus is on penetrating the first-line RF negative patient market, particularly in the United States and beyond through international reimbursement efforts. Future growth is anticipated with potential market expansion from forthcoming non-transfusion dependent data. The conversation then shifts to the EXALIBER study, addressing questions about the potential for obtaining approval based on MRD (Minimal Residual Disease) negativity as an intermediate endpoint, and the implications of CAR T cell therapy moving into second-line treatment for iveratomide's usage in combination therapies. Key endpoints of the study include MRD, progression-free survival (PFS), and overall survival, emphasizing the need to view these in conjunction with each other.

The paragraph discusses the regulatory considerations and potential positioning of ibrutinib and other treatments like iverdamide and mezictimide in the context of multiple myeloma treatment. It highlights that while CAR cell therapies are mainly limited to academic centers, there is a significant unmet medical need for small molecules and combination therapies in community settings where most patients are treated. The market for multiple myeloma treatments is competitive and fragmented, with cell therapies primarily used in specialized centers. The discussion emphasizes the promise of novel cell mod agents in providing effective, manageable, and convenient treatment options, with ongoing pivotal trials exploring different combinations and settings.

The paragraph discusses the ACCALIBER study for MEVI, highlighting excitement around the potency of sacitamab, which is anticipated to have results by early 2026. It mentions the potential launches of these assets. Then transitions to a Q&A session where Kripa Devarakonda from Truist Securities asks about RACE101 expected outcomes in first-line small cell lung cancer and recent FDA changes. Christopher Boerner defers the question to Samit Hirawat who emphasizes anticipation of the Phase one study results for small cell lung cancer treatments, focusing on safety and efficacy compared to historical controls, with expectations for data by the end of the year.

The paragraph discusses the collaboration between a pharmaceutical company and the FDA to ensure timely approval of new therapies, highlighting recent approvals that were on time or even completed ahead of schedule. It emphasizes ongoing constructive work with regulators to ensure that transformative therapies reach patients without delays. James Shin of Deutsche Bank asks about factors influencing future policy steps, such as visibility on US corporate tax reform or pharma tariff rates, and how they might affect budgeting. Chris Boerner and Samit address the question, noting the fluid policy environment and the need to monitor various aspects. Additionally, Shin asks for Samit's views on recent PD-one VEGF datasets, inquiring whether they are consistent and competitive with existing PD-one data.

The paragraph discusses the importance of tax policy, particularly the US corporate tax rate, in encouraging investment in research and development within the United States. It credits the reduction of the corporate tax rate to 21% in 2017 with positively impacting US investment in R&D. Additionally, Samit Hirawat talks about promising developments in cancer research, specifically regarding PD-one VEGF treatments and a new phase three study in China. The focus is on progression-free survival benefits, overall survival data, and safety between treatment arms. Hirawat also highlights ongoing work in non-small cell lung cancer research, including precision-driven approaches and immunotherapy combinations.

In the closing remarks of the call, Christopher Boerner emphasizes that Bristol-Myers Squibb is focused on consistent and clear priorities. The company is showing growth and making progress by better aligning its cost structure with its revenue base. They are anticipating several key pipeline readouts and have multiple upcoming catalysts. Their strong financial position allows flexibility in capital allocation and business development. Boerner acknowledges the hard work of colleagues and reaffirms the company's commitment to achieving significant growth and attractive shareholder returns by the end of the decade. The conversation ends with an invitation for follow-ups and well wishes for the week.

This summary was generated with AI and may contain some inaccuracies.