The paragraph is an introduction to the Bristol-Myers Squibb Fourth Quarter 2024 Earnings Conference Call. Chuck Triano, Senior Vice President and Head of Investor Relations, welcomes attendees and outlines the structure of the call. Key participants include Chris Boerner, David Elkins, Adam Lenkowsky, and Summit Hirawat. The company's quarterly slide presentation is available online. Triano notes that the call will include forward-looking statements that may differ from actual results, and emphasizes the use of non-GAAP financial measures. Comparisons will be made to the same period in 2023, excluding foreign exchange impacts.

The paragraph discusses the company's achievements and future plans. It highlights that 2024 was a successful year, laying a strong foundation for sustainable growth. The company experienced double-digit growth in its portfolio, led by products like BREYANZI and Opdivo. They also made significant commercial and R&D progress, including reentering the neuroscience field with a new treatment for schizophrenia and launching a new formulation of Opdivo. The company focused on operational excellence and financial discipline, reallocating significant resources towards high-growth opportunities and nearly achieving $1.5 billion in savings. Their 2025 guidance is also mentioned, indicating a focus on continuing this momentum.

In 2024, the focus on improving R&D productivity has led to accelerated progress in several late-stage programs, including the early completion of enrollment for the CEMZIOS study in non-obstructive HCM and moving up the timeline for the ADEPT 2 study in Alzheimer's disease psychosis, following the acquisition of Karuna. The ibertamideexcaliber trial in multiple myeloma also finished enrollment ahead of schedule. The company is working on operational excellence by aiming to become leaner, identifying $2 billion in savings to be realized by 2027, and maintaining financial discipline while investing in growth areas. The U.S. approval of Cobintian for schizophrenia marks an important achievement in 2024 and the product launch has begun successfully.

The paragraph outlines the company's strategic focus on expanding its clinical development program beyond schizophrenia, with plans to initiate multiple Phase III studies in various indications including Alzheimer's disease, bipolar disorder, and autism spectrum disorder irritability. The company anticipates numerous data readouts and registrational catalysts over the next few years, highlighting key developments in 2025 and 2026 for potential first or best-in-class medicines. It emphasizes the commitment to investing in growth drivers while maintaining financial discipline, and projects 2025 revenue to be approximately $45.5 billion, acknowledging the impact of generics and the strength of its growth portfolio.

The paragraph discusses BMS's financial outlook and strategic direction. The company expects its 2025 non-GAAP earnings per share to range between $6.55 and $6.85, supported by an expanded savings program. BMS is undergoing a transformation with a younger, more diversified growth portfolio, including the promising drug Coben. Over the next 24 months, BMS plans to launch 10 or more new medicines and explore over 30 indication expansion opportunities. They remain focused on areas with a successful track record and aim for sustainable growth by the decade's end. David Elkins will review the 2024 financial results, noting strong fourth-quarter sales growth of 9%, reaching $12.3 billion, driven by portfolio volume growth and higher market inventory levels.

The company's growth portfolio saw a strong quarter with a 23% sales increase, led by brands like Reblozyl, KENZO, and Optolag. While legacy brands like Electus had higher sales, others like Revlimid faced generic competition. Overall, the company had a successful year, laying a foundation for sustainable growth. Opdivo showed solid growth in oncology due to higher volume, and education efforts for Opdivo Kuventeg are set for 2025 with expected low single-digit growth. Optolag saw double-digit growth in first-line melanoma care both in the U.S. and new international markets. In cardiovascular, Eliquis had over $3 billion in sales, with 19% U.S. growth, though Medicare Part D changes may slow Q1 growth. KEmZyOs sales more than doubled, driven by demand and inventory buildup.

The paragraph provides an update on the pharmaceutical company's performance across various therapeutic areas in the fourth quarter. KIMZYO gained approximately 1,300 new patients for obstructive HCM, and a label update in Europe has eased echo monitoring requirements, with a similar update expected in the U.S. Rebase showed over 70% growth, especially strong in new markets like Europe and Japan. In cell therapy, BrionZ's sales more than doubled due to high demand. In immunology, global sales of STC increased by over 30%, though higher rebates affected U.S. sales. Improved access expected in 2025 should boost demand despite increased rebates. For CERTIKTU, sales are expected to be initially tempered by rebates. Lastly, Covent achieved around $10 million in sales, representing two months and initial stocking.

The paragraph discusses the company's recent financial performance and strategic initiatives. It highlights strong prescription uptake for Cobenfi, noting positive feedback from patients and physicians. The company's gross margin declined slightly due to product mix changes, and operating expenses rose by 8% mainly because of R&D investments, though partially offset by cost-saving measures. Significant progress was made on a $1.5 billion productivity initiative, with $1.1 billion in savings achieved by the end of 2024 and the remainder expected in 2025. The effective tax rate for the quarter was 19.9%, and diluted earnings per share were $1.67 for the quarter and $1.15 for the full year. The balance sheet is strong with $11.2 billion in cash equivalents and marketable securities, and $4.4 billion in cash flow generated from operations in the fourth quarter. Capital allocation strategies include business development, debt reduction, and returning cash to shareholders via dividends, with $6 billion of $10 billion debt repaid by the end of 2024. The company has a 93-year history of paying dividends, continuing its commitment to shareholders.

The paragraph outlines an expanded strategic productivity initiative aimed at achieving $2 billion in incremental operating expense savings, with $1 billion expected by 2025 and the remainder by 2027. This will involve organizational redesign and operational efficiencies, each contributing to half of the savings. Unlike the previous $1.5 billion program, these savings will directly improve the bottom line. The goal is to make the company leaner and more efficient while investing in growth areas. Revenue for 2025 is projected at $45.5 billion, with a decline in the legacy portfolio due to generics and foreign exchange headwinds, partially offset by strong performance from growth brands.

The company expects a 2025 gross margin of about 72% due to product mix, and plans to reduce operating expenses to approximately $16 billion through cost-saving measures. Operating margin is projected at 37%, with $30 million in OI&E income and an 18% tax rate. Non-GAAP earnings per share are expected to be between $6.55 and $6.85. Quarterly revenue is expected to be impacted by Q1 inventory destocking and Medicare Part D pressures, particularly affecting Eliquis, but should improve in the second half of the year. The legacy portfolio is projected to decline 10-12% sequentially due to generic competition. Overall, revenues are expected to normalize in Q2, with a stronger second half. The company remains confident in delivering long-term value, supported by strong 2024 performance and a focused growth strategy.

The paragraph covers a Q&A session in which Chris Schott from JPMorgan asks two questions. The first question is about the drug Cobenfy, specifically its market ramp, given existing physician prescribing habits and the unmet need it aims to address. The second question concerns a cost program and whether completed cost reductions will place the company in a favorable position for future challenges, particularly referencing the 2028 loss of exclusivity for certain drugs. Christopher Boerner defers the first question to Adam Lenkowsky, who states that the Cobenfy launch is progressing well, with about 1,000 weekly prescriptions and successful access goals, particularly with Medicaid and Medicare. Christopher Boerner plans to address the second question himself.

The company has achieved significant access to Medicaid and Medicare, covering over 80% of lives in the category, and is making progress with commercial payers for Cobenpi, a new schizophrenia treatment with a differentiated profile. Despite facing challenges, they are seeing positive feedback and enthusiasm due to its efficacy and safety. With ongoing educational efforts aimed at changing prescribing habits, they anticipate strong uptake through 2025 and aim to make Cobenpi a major product. Additionally, they are committed to growth-focused investments, including initiating seven Phase III programs this year and making substantial commercial investments, contributing to progress with products like CEMZYOS, OPDIVO, and BRIAN.

The paragraph discusses a company's focus on growth, emphasizing that investing in growth is their top priority. They have identified opportunities to become more agile and efficient, which they plan to seize now. This decision aligns with their current cost-cutting programs, aiming to give them more financial and strategic flexibility while ensuring the organization is appropriately scaled to its business needs. In a Q&A session, Luisa Hector asks about assumptions for Part D redesign in 2025 and updates on cendakimab. Christopher Boerner delegates these questions to Adam Lenkowsky, who explains that Part D redesign will favor Eliquis due to the removal of the coverage gap and the changes should lead to more consistent sales throughout the year.

The paragraph discusses the sales expectations for various pharmaceutical products. Eliquis is expected to have its lowest sales quarter in Q1 but strong year-on-year growth. Other products like REVLIMID, POMALYST, ORENCIA, and CAMZYOS will offset Eliquis's performance due to increasing gross-to-net pressure as patients enter the catastrophic phase. The company anticipates a roughly net-neutral impact across its portfolio. The decision has been made not to commercialize cendakimab based on current data, prioritizing investments where the company has a competitive advantage. Similar decisions were made previously with Zeposia in UC after an unsuccessful trial in Crohn's disease. Additionally, Geoffrey Meacham from Citi inquires about expansion opportunities for CoVENFI and potential changes to investment plans following the emracladine failure, as well as the impact of RFKJ's upcoming nomination on potential IRA revisions.

The paragraph discusses discussions around future discounting and competitive dynamics related to the product Cobenfy. Christopher Boerner highlights their focus on long-term opportunities despite short-term challenges, emphasizing accelerated programs. Samit Hirawat talks about the potential of Cobenfy's unique dual muscular agonism mechanism in treating dementia-related disorders and the goal of expanding its applications. Adam Lenkowsky points out the advantage Cobenfy has over generic atypicals in terms of safety and efficacy, emphasizing its benefits in managing schizophrenia symptoms, including positive symptoms, negative symptoms, and cognition.

The paragraph discusses the company's strategic focus and policy priorities. It highlights their anticipation of competition in schizophrenia drugs by 2026-2027, following the failure of erracladine, and their optimism about Cobenfy's prospects. Christopher Boerner emphasizes the company's commitment to bipartisan collaboration, particularly with the new Congress and President Trump's administration, with an emphasis on fostering innovation and supporting the FDA's mission. He also addresses concerns with the IRA price setting process, seeking to make necessary adjustments and mitigate its adverse effects. Finally, an unknown analyst remarks on the company's ability to multitask while managing costs and integrating businesses.

The paragraph discusses the focus on operational excellence and R&D productivity to advance timelines and deliver value to the company and its shareholders. Christopher Boerner emphasizes the importance of staying focused on value-driving elements, which has accelerated numerous programs. Samit Hirawat adds that adhering to established principles, from drug discovery to proof of concept, and examining the late development process has identified areas to shorten timelines. This strategic focus has led to a wave of upcoming catalysts within the next 24 months.

The paragraph discusses a strategic approach taken by a company to prioritize its portfolio by stopping some trials and focusing on areas with strong scientific potential to achieve proof of concept and accelerate drug development. It highlights progress made in delivering data for psoriatic arthritis and KENZYOS, and mentions ongoing work on trials for multiple myeloma, LPA1, IPF, and SLE. Christopher Boerner emphasizes the importance of delivering 15 or more registrational trials by the end of next year, noting significant progress in 2024. The paragraph ends with anticipation of a question from Tim Anderson of Bank of America regarding revenue guidance differences and potential contributors, such as Codensa.

In the past, Chris suggested that trough earnings might occur in the late 2020s, possibly around 2028 or 2029. Christopher Boerner and David Elkins discussed the company's current outlook and guidance. They acknowledged the impact of loss of exclusivity (LOE) on products like Revlimid and POMALYST, particularly in Europe and the U.S., affecting short-term earnings. However, they emphasized their confidence in the long-term prospects due to the new product portfolio and upcoming asset developments expected to shape the company's future in the latter part of the decade. David Elkins highlighted the company's revenue guidance of approximately 45.5%, mentioning a currency headwind of around $500 million, and noted that the revenue outlook is generally in line with consensus.

The paragraph involves a discussion led by Christopher Boerner, addressing the company's approach to managing growth and potential downturns. Boerner emphasizes that the company is not providing long-term guidance to remain accountable for measurable outcomes, but is focused on achieving top-tier growth by the end of the decade. The strategy includes accelerating brand and pipeline growth, using capital efficiently, and speeding up product introduction, exemplified by the acquisition of Karuna to include Cobinfi in their offerings. The aim is to be nimble and transparent in performance. The paragraph ends with Chuck Triano inviting a question from Mohit Bansal of Wells Fargo regarding the medication Eliquis, specifically about its potential benefits due to changes in design and lack of a coverage gap ("donut hole").

The discussion in this paragraph revolves around the expected growth of the pharmaceutical brand Eliquis in the U.S. due to changes in Part D redesign, specifically the elimination of the coverage gap. This change is anticipated to result in a shift in sales patterns, with the lowest sales in Q1 and higher sales in the latter half of the year, leading to strong double-digit growth overall. The market share for Eliquis is growing, particularly with the absence of its competitor, Xarelto, enhancing its market position. Additionally, the conversation touches upon future considerations for gross margin dynamics related to REVLIMID step downs and explores early insights into the access and coverage of Opdivo Quantic for 2025.

The paragraph discusses the sales dynamics of Eliquis, noting that contrary to usual trends, sales will be higher in the second half of the year. Adam Lenkowsky comments on Opdivo Quvantic, highlighting the early stage of its rollout and the educational efforts with healthcare practitioners regarding subcutaneous (subcu) versus intravenous (IV) administration. Feedback has been positive, especially for adjuvant patients, due to a shorter infusion time. Some NCCN guidelines have been updated to include the new treatment, but reimbursement dynamics are in transition due to a temporary J code, with full conversion expected to accelerate after a permanent code is issued in July. The overall message is optimism about the product's impact and the longevity of the franchise.

Evan Seigerman asked about the decision-making process behind choosing Karuna for entering the schizophrenia treatment market, particularly in light of the muscarinic debate and developments with Coventry and peer acumen. Christopher Boerner explained that the senior leadership team took ownership of the Karuna acquisition decision, emphasizing the importance of capital allocation and business development. He highlighted their disciplined approach, which included a focus on Karuna’s compelling science, strengthening therapeutic areas, and ensuring financial viability to add value to the company and shareholders.

The paragraph discusses the company's efforts to integrate and develop an acquired asset, emphasizing the importance of learning lessons and quickly executing business development strategies. Adam Lenkowsky responds to a question about CMIOs, highlighting consistent growth from Kim Zios, with 12,000 patients in the hub and 9,500 on commercial drugs by the end of 2024. The company aims to increase prescribing depth in larger centers and expand into smaller institutions and community practices. They anticipate growth through easing echo requirements, allowing physicians to treat more patients, and expect a significant data readout in nonobstructive HCM. This could expand the eligible patient population by 30%, giving Kamo a first-mover advantage.

In this paragraph, Akash Tewari from Jefferies asks about the risks associated with the adjunct schizophrenia trial for KabEnfI, noting the general difficulty of such trials and questioning the likelihood of success. Samit Hirawat responds by highlighting the drug's development as a monotherapy and detailing the trial process, including washout periods and ongoing safety evaluations over a 52-week follow-up. Hirawat expresses confidence in the drug's safety profile and mentions that the trial results are expected soon, with additional ADAPT trials concluding later in the year. Hirawat also emphasizes the importance of reducing the burden on healthcare providers and patients regarding the Camis label update and echo monitoring requirements.

The paragraph discusses the safety profile and regulatory updates for Camzyos, a medication with dosages of 2.5 and 5 milligrams. The data from real-world use and clinical trials support its ongoing safety, which led to regulatory actions, such as in Europe where the monitoring frequency via echocardiograms during the maintenance phase was reduced from every 12 weeks to every 6 months. This change is anticipated to allow more patient treatments at specialized centers. In a subsequent part, Terence Flynn from Morgan Stanley asks about a productivity initiative and iberdomide's regulatory pathway related to a Minimal Residual Disease (MRD) endpoint. David Elkins confirms an incremental program to boost revenue by $2 billion and its impact on profit.

The paragraph discusses two main topics: financial projections and clinical trial developments. The company anticipates reducing operating expenses by $1 billion by 2027, aiming for $15 billion in operating expenses. Samit Hirawat emphasizes the importance of using Minimal Residual Disease (MRD) as a primary endpoint in clinical trials for multiple myeloma, highlighting the need for accelerated drug development due to the lack of a cure. Discussions with the FDA about incorporating MRD as an endpoint are ongoing, alongside traditional endpoints like progression-free survival (PFS) and overall survival. Christopher Boerner adds that cost savings will be balanced with investments in growth opportunities.

In the paragraph, Courtney Breen from Bernstein asks about the company's focus on business development and its alignment with therapeutic areas, particularly following recent acquisitions. Christopher Boerner responds by emphasizing that business development, including partnerships and acquisitions, is a priority. The company aims to strengthen its position in core therapeutic areas by integrating promising science and acquiring assets to enhance growth. Boerner also highlights that the assessment of potential opportunities involves considering the scientific appeal, financial viability, and the potential to provide value to the company and shareholders.

The paragraph discusses the strategic financial position of a company, emphasizing opportunities to strengthen their core therapeutic areas, especially through business development. It features comments from Adam Lenkowsky on the focus of certain medical treatments on public sectors like Medicare and Medicaid, particularly for indications related to schizophrenia, Alzheimer's, autism, and bipolar disorder. There's mention of a specific brand largely being in the public arena due to Medicaid best pricing. Additionally, Seamus Fernandez from Guggenheim Securities asks about the experience and tolerability of a treatment called Cobenfy, specifically addressing BID dosing and its impact on the GI profile. Fernandez also inquires about the market position of novel oral drugs for multiple myeloma compared to generic alternatives.

The paragraph discusses positive feedback from physicians and patients about a new treatment's efficacy and safety, especially its ability to improve symptoms with a low starting dose of 50 milligrams. Patients are reportedly experiencing improvements in both positive and negative symptoms, cognition, and quality of life, such as reengaging with family or returning to work. The treatment's side effects, like nausea and vomiting, are considered manageable, especially since physicians are starting patients on the lowest dose and gradually increasing it, unlike the quicker titration observed in clinical trials. There are no major concerns about the treatment being taken twice daily, and an ongoing study is examining the impact of taking the medication with food, which could further aid physicians in prescribing and increase patient convenience. Samit Hirawat is expected to add more information to this discussion.

The paragraph discusses advancements in schizophrenia treatment with the drug Cobenfy, highlighting its ability to address both positive and negative symptoms and impact cognition. It then shifts focus to multiple myeloma treatments, specifically mentioning challenges with accessing complex therapies in community settings. The development of small molecules like Iberdomide, which can be easily combined with standard treatments, is highlighted as a solution. Iberdomide and mesictamide are in trials being compared to other drugs. The latter part involves a conference call where David Risinger asks about the company’s growth trajectory, noting that poor performance of loss of exclusivity (LOE) products in 2025 could set up better growth for 2026, while better-than-expected performance might make future growth more challenging.

The paragraph discusses the strong performance and growth prospects of the company's products. RV has shown considerable growth, expected to grow roughly 20% in the fourth quarter and the full year 2024. Christopher Boerner, David Elkins, and Adam Lenkowsky provide insights into future growth, noting the anticipated impact of generic entries for REVLIMID and the focus on investing in growth areas. The growth portfolio is performing well, representing over 50% of business, with expectations for additional new molecular entities (NMEs) and contributions from products like Cobenfy. YERVOY is experiencing solid demand growth in several core indications, highlighting the company's strong growth trajectory heading into the latter part of the decade.

The paragraph discusses growth in both U.S. and international markets, particularly highlighting advancements in cancer treatments. The speaker notes significant milestones, including a 10-year data release in first-line melanoma and upcoming launches for first-line HCC and MSPCRC treatments, both in combination with Yervoy. They also mention pending approval for Opdivo Yervoy in China, anticipating continued growth for Yervoy by 2025. The discussion shifts to address Matthew Phipps' question about multiple myeloma trials, emphasizing the novelty of using MRD as a registration trial endpoint. The speaker explains the need for ongoing patient monitoring to assess MRD durability, response rates, and other critical metrics in the Iberdomide trial, highlighting this as a discussion point with the FDA.

The paragraph discusses the evaluation of using an earlier MRD endpoint readout to expedite the development of multiple myeloma assets, considering factors such as timing, population, and event accrual. Future studies may target more difficult-to-treat populations. Adam Lenkowsky highlights the competitive multiple myeloma treatment space, emphasizing the commitment to the drug Abema and the promising role of GPRC5D with better safety in treatments. Steve Scala from TD Cowen asks about Bristol's second-generation TYK2 agent in psoriasis and its plans, including IBD, as well as the timeline for Milvexian Phase III readouts in stroke and ACS expected in 2026. Samit Hirawat responds, noting ongoing plans for Sotika.

The paragraph discusses the focus on Sotto within the company's development pipeline and mentions that a particular ticket is not in development. It provides updates on the SSP and ACS projects, indicating positive tracking and enrollment, with expected readout at the end of 2026. Kripa Devarakonda from Truist Securities raises questions about the EU label update and future opportunities with CAMZyOS, including expectations for upcoming ODYSSEY data. Adam Lenkowsky responds, mentioning an anticipated PDUFA date in April and efforts to reduce the echo requirements for patients and physicians. He highlights ongoing steady growth for Caxias, emphasizing high patient retention and the expansion of prescribers, contributing to the drug's revenue growth as patients remain on the therapy due to its effectiveness.

The paragraph discusses the anticipated ODYSSEY study results, expected to be available in Q2, which will impact approximately one-third of patients with HCM and build upon current successes with a first-mover advantage. Samit Hirawat briefly addresses the Odyssey-related inquiries, noting that relevant methodology and patient data have been published in JACC Heart Failure, with primary endpoints like KCCQ and PVO2 clearly defined. Results are anticipated in the coming quarter for further sharing. Additionally, Adam Lenkowsky mentions that efforts are ongoing to ensure broad access to Covent across the U.S. Olivia Brayer from Cantor Fitzgerald inquires about data submitted to the FDA for less restrictive camsiosrans, questioning any additional submissions compared to previous ones and clarifying proposed updates regarding monitoring frequency and LVOT gradient. Adam also notes an update on the European label to reduce frequency.

In the paragraph, Samit Hirawat and Adam Lenkowsky address questions about regulatory updates and clinical trial data. Hirawat mentions ongoing discussions with the FDA and highlights the strong data package from both clinical trials and real-world evidence. Lenkowsky clarifies that in Europe, the frequency of echo monitoring for patients on Censis has been reduced post-week 12, from every 12 weeks to every six months. James Shin from Deutsche Bank asks about the expectations for the PANscore benefit and the disclosure of ADP 2 data. Hirawat explains that if the Adapt trial reads out, a press release will be issued without detailed data, which will be presented at a medical conference later. He also notes that the magnitude of difference between trial arms and baseline measures will be key endpoints for the RISE study.

The paragraph discusses a company's focus on its targeted radiotherapeutic portfolio and prioritization of investment in business development and internal development. Currently, they are conducting Phase III trials for a treatment in the GAP NET patient population, having already shown strong Phase I results. They are also studying the drug's effects on small cell lung cancer and have initiated a breast cancer program. Additionally, the company plans to start a Phase I program for a new target, GPC3, and has a research pipeline. They remain open to business development opportunities to enhance their platform, as long as these are financially and scientifically sound.

Christopher Boerner expresses confidence in the company's pipeline, highlighting several key assets expected to drive revenue in the coming years. He mentions exciting programs such as Cobin, CELMoDs, including Ibara and gocotomide, Melexionis, and future prospects like CD19, XT, ARLDD, and LPA1. The company is focused on strong commercial execution and leveraging upcoming pipeline catalysts while maintaining financial flexibility and enhancing value through business development. Boerner acknowledges the team's hard work and the progress made in 2024.

The paragraph outlines a company's commitment to adjusting its cost structure and investing in future growth as part of a multiyear strategy. The main goal is to transform the business to achieve top-tier growth and deliver attractive returns for shareholders by the decade's end. The paragraph concludes with an appreciation for the audience's participation and an invitation for follow-up contact, signaling the end of the conference call.

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