默沙东集团 (MRK.US) 2025年第三季度业绩电话会
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会议摘要
Merck's third-quarter earnings highlight strong performance in oncology and animal health, with key advancements in pipeline products including subcutaneous administration of Keytruda, progress in ADCs, and cardiovascular treatments. The company anticipates growth through strategic acquisitions, focusing on oncology and immunology, while navigating market challenges with robust capital allocation and business development strategies.
会议速览
The company discusses its third quarter sales and earnings, emphasizing progress in science and patient care, ongoing investments in a robust pipeline, and upcoming phase 3 trial readouts across various therapeutic areas. Future growth is anticipated through new launches and strategic business development, with a strong commitment to disciplined science and value-driven strategies.
The company advanced its pipeline, completed a strategic acquisition, and discussed health care policy goals with the administration. It emphasized investments in U.S. manufacturing and R&D, aiming for long-term growth, innovation, and value creation for patients and shareholders.
Solid Q3 results highlighted by advancements in oncology, cardiovascular treatments, and immunology. Positive Phase II study results for a PCSK9 inhibitor in hyperlipidemia, FDA approval for subcutaneous premal luzinda, and expansion of immunology efforts including phase 2B trials. Strategic business development remains a priority with potential targets under assessment. Enhanced portfolio diversification and growth drivers through pipeline investments and new product launches.
The company delivered solid Q3 results with 4% revenue growth, excluding foreign exchange, led by oncology and animal health. Keytruda sales rose 8% to $8.1 billion, supported by increased use in earlier stage cancers and metastatic indications. New product launches and robust demand in various segments contributed to the growth, reinforcing the company's confidence in its science-led strategy for long-term value creation.
The company reports robust growth in animal health sales, driven by increased livestock demand, with a focus on strategic investments in R&D and pipeline expansion. Despite challenges in companion animal sales, earnings per share rose, and guidance for future revenue and operating expenses was provided, highlighting continued commitment to innovation and shareholder value.
Updates on FDA and European regulatory approvals for cancer treatments, vaccine advancements, and cardiovascular disease therapies. Notable clinical milestones include pembrolizumab subcutaneous administration, positive opinions for subcutaneous Keytruda, and approvals for pneumococcal and RSV vaccines. Cardiovascular highlights include a PCSK9 inhibitor meeting primary endpoints. Key upcoming events include PDUFA dates for oncology and HIV treatments, and data presentations from ongoing trials in various therapeutic areas.
Discussed ongoing business development efforts focusing on strategic therapeutic areas and a preference for pipeline asset acquisitions over large, synergy-driven deals. Emphasized urgency in assessing potential targets and maintaining a deal size range of $1 to $15 billion, with flexibility for larger opportunities driven by scientific value.
The dialogue discusses the potential expansion of an immunology drug's development pipeline, focusing on initial GI indications and considering further applications in rheumatoid arthritis, dermatology, and fibrosis-related conditions like Crohn's disease. The phase 2 studies in these areas are crucial for assessing the drug's broader therapeutic potential beyond inflammation control.
The dialogue centers around solid tumor treatment strategies, highlighting the effectiveness of Trop-2 ADCs, specifically Sac TMT, in showing a 6 to 12 month overall survival benefit. The discussion also explores the potential of combining PD-1 and VEGF inhibitors, emphasizing the unique differences among Trop-2 ADCs and the excitement for phase 3 trials, particularly in global and US patient populations.
The influenza vaccine launch in the U.S. has received positive feedback, with initial stocking orders exceeding $75 million. Despite a slight delay in approvals, the vaccine's benefits, including no weight-based dosing, are expected to drive significant uptake, especially as the RSV season approaches. Customer feedback is favorable, anticipating a strong impact in the upcoming season and beyond.
The discussion focuses on the significant contribution of early stage indications to sales growth, highlighting cervical, RCC, TNBC, and non-small cell lung cancer as key drivers. With over half of the growth attributed to these earlier stage settings, the company anticipates further expansion, including potential approvals in muscle invasive bladder cancer, and notes the importance of these segments for upcoming launches.
A question about industry framework for Mfn deals and Merck's progress in discussions with the administration leads to an affirmation of alignment with administration goals to lower patient costs and ensure fair contributions from foreign governments. Merck expresses optimism for a constructive resolution, emphasizing ongoing discussions without specific updates.
The dialogue highlights the significance of overall survival (OS) data in the advancement of a first-in-class treatment. The discussion emphasizes the excitement around potential top-line phase 3 results, particularly the efficacy of a new agent in combination with existing therapies, and its importance for patient outcomes and regulatory approval.
A question is posed regarding the factors influencing the top line for 2026, with a request for insights on revenue drivers without formal guidance, acknowledging prior comments on expenses.
Discusses expected top-line growth driven by new product launches, including oncology and animal health, alongside challenges from generic competition and price pressures in ex-US markets.
Clarifies the timeline for Cadence trial results, emphasizing the importance of these outcomes for determining the broader application of Wind River therapy beyond its initial patient group.
Discussion on Merck's expected revenue ratio between US and international markets in five years, influenced by product mix and pricing dynamics, with emphasis on US-based opportunities in the pipeline.
The discussion focuses on the challenges faced by Gardasil, a vaccination product, in the current year and speculates on its growth potential by 2026. It considers factors like changing attitudes towards vaccinations, updated guidelines, and the recovery from impacts in China and Japan, questioning whether consensus forecasts a strong rebound in the product's market performance.
The discussion focuses on Gardasil's impact in preventing HPV-related cancers, noting growth in younger and mid-adult vaccination segments outside the U.S., offset by a decline in adolescents due to reduced eligible populations. Challenges include the U.S. dosing schedule recommendation's potential impact on growth. Globally, public programs have matured, offering routine vaccination, while the private market, especially for mid-adults, presents growth opportunities. Efforts to activate broader age cohorts for private segment growth are ongoing, with expectations of modest near-term growth for Gardasil.
Expectations for Keytruda's subcutaneous conversion remain on track with 30-40% patient adoption expected over 12 months. Growth may slow initially due to temporary J codes. Keytruda's overall growth, including the new subcutaneous form, will be a key contributor, with separate sales reporting anticipated from 2026 onwards.
The dialogue discusses the significance of the phase 3 Brunello trial for Mk 3000, a novel candidate targeting the Wnt pathway, and its potential to revolutionize treatment in diabetic macular edema and neovascular age-related macular degeneration. The conversation highlights the drug's promise in addressing a large, underserved market, estimating a multi-billion dollar opportunity, and emphasizes the company's strategic investment in commercial infrastructure to capitalize on this breakthrough.
要点回答
Q:What are the key components of Merck's progress as discussed in the speech?
A:Merck's progress includes the use of their leading science to save and improve lives worldwide, delivering value to patients and customers through innovative medicines and vaccines, making important investments in their diverse pipeline with about 80 phase 3 trials, and having over $10 billion in revenue opportunities by the mid-2030s.
Q:What important pipeline advancements and strategic acquisitions has Merck mentioned?
A:Merck completed the strategic acquisition of a company with multi-billion-dollar commercial potential, which is a significant pipeline advancement. They have also announced investments in manufacturing in the US, including a groundbreaking event at their Virginia site and plans for investment of more than $70 billion to expand domestic manufacturing and R&D.
Q:What are the recent developments and progress in Merck's oncology and cardiovascular therapy areas?
A:In oncology, Keytruda sales increased 8%, driven by robust uptake in earlier stage cancers and combination therapies. In cardiovascular therapy, WRAAE sales grew strongly with over 24,000 total prescriptions dispensed in the quarter, supported by new patient starts and a good start in Japan.
Q:What is the impact of recent strategic business developments and global investments by Merck?
A:Strategic business developments and global investments by Merck are translating into positive clinical results and successful new product launches, which are improving the company's portfolio diversification and setting the stage for future growth.
Q:What are the key financial figures and market performance of Merck's products as reported in the speech?
A:Key financial figures include total company revenues of $17.3 billion and oncology sales of Keytruda increasing 8% to $8.1 billion. In vaccines, Gardasil sales decreased 25% to $1.7 billion, while in cardiovascular, WRAAE sales were $360 million. The animal health business saw a 7% sales increase.
Q:What was the impact of the acquisition of Verona Pharma and the restructured agreement for coseli Go on the company's full year revenue and other financial assumptions?
A:The acquisition of Verona Pharma and the restructured agreement for coseli Go influenced the company's financial guidance for the full year, with expected revenue between $55 billion and $65 billion, representing growth of 1 to 2%, excluding a negative impact from foreign exchange. The guidance also included an updated estimate of less than $100 million in costs related to the impact of tariffs, with operating expenses assumed between $25.9 and $26.4 billion and other expense between $400 and $500 million.
Q:What is the updated tax rate assumption for the full year, and how many shares are outstanding according to the company's guidance?
A:The company's guidance for the full year assumes a tax rate between 14 and 15%, with an assumed number of approximately 2.51 billion shares outstanding. This leads to an EPS guidance of between $8.93 and $8.98.
Q:How is the company's investment strategy for the upcoming year, particularly regarding R&D and S&A expenses?
A:The company intends to fully invest behind their opportunities, with an expectation for an acceleration in underlying operating expense growth driven by investment in Research and Development (R&D) and Sales and Marketing (S&A) to fuel their pipeline and new launches. They plan to invest more than half a billion dollars to maximize the potential of oveh, to continue bringing forward innovative medicines and vaccines, and to drive growth for the company.
Q:What were the key updates in oncology, vaccines and infectious disease, immunology, ophthalmology, and cardiovascular and pulmonary programs?
A:Key updates in oncology include FDA approval for cotrina Q Le injection for subcutaneous administration of pembrolizumab and a positive opinion from the European Medicinal Products Agency's Committee for Medicinal Products for Human Use on the same. The company has also made progress with its pipeline through various clinical trials and has received positive results for certain programs.
Q:What clinical trial results and future directions were highlighted in the company's updates?
A:The company highlighted completed enrollment in the phase 3 Atlas trial in ulcerative colitis and the phase 3 Aries trial in Crohn's disease, along with expansion of the development program for evaluating Tuli soapbar in dermatology and rheumatology indications. They also discussed a phase 2 study evaluating Mk 3000 in patients with neovascular macular degeneration and retinal vein occlusion, and plans to initiate late-stage trials in 2026. In the cardiovascular and pulmonary programs, they talked about the continued evidence for benefit of Wimber Vir in patients with pulmonary arterial hypertension and the closing of the Verona Pharma acquisition to advance the ongoing work in bronchiectasis and evaluate utility and additional indications.
Q:What were the results of the Coral Reef Lipid Study and when will the detailed results be presented?
A:The investigational oral PCSK1 inhibitor met all primary and key secondary endpoints in the Coral Reef Lipid Study, demonstrating a statistically significant and clinically meaningful reduction in LDL cholesterol for the treatment of adults with hypercholesterolemia. The detailed results of the study, as well as another study focused on familial heterozygous hypercholesterolemia, will be presented at the American Heart Association scientific sessions meeting in New Orleans in November.
Q:What progress is being made across the pipeline and what are the upcoming milestones?
A:The company continues to see strong momentum across the pipeline with phase I and II trials underway across multiple therapeutic areas. More than 15 phase III trials have been initiated this year, and an increasing number are expected in 2026. In the first half of 2026, there will be a regular cadence of milestones across therapeutic areas, including oncology. Specific upcoming milestones include the February 2026 PDUFA date for certain patients with platinum-resistant recurrent ovarian cancer based on Keynote B-96, the April 7, 2026, PDUFA date for earlier-stage NSCLC based on Keynote 905, the April 28, 2026, PDUFA date for the combination of Deray and Ela as an oral once-daily treatment regimen, and data from phase 3 trials and immunology phase I data for tulastar B from the Athena study and SSc-ILD in cardiopulmonary disorders.
Q:What are the updated views on potential transformative larger transactions in the industry?
A:The company's view has not changed; they do not consider a transformative acquisition or a synergy-driven deal necessary for their future. They have one of the most robust pipelines and see large synergy-driven deals as disruptive to their current activities. Their focus remains on bringing in pipeline assets rather than pursuing those types of deals.
Q:What are the development program focuses and potential indications for Tll-1 An in the immunology space?
A:The initial focus of the development program for Tll-1 An was in the gastrointestinal (GI) space, aiming to be the first-in-class 1A agent. However, the company has also expanded its focus to include indications suggested by recent phase 2B studies in rheumatoid arthritis and dermatology. While acknowledging that additional development opportunities in the INR space are still possible, the company is particularly interested in phase 2 studies for ulcerative colitis and Crohn's disease due to fibrosis, as well as phase 2 studies for SSc-ILD.
Q:What are the potential benefits of Trop-2ADC over PD-1 therapy, and how might this impact future phase 3 trials?
A:The potential benefits of Trop-2ADC over PD-1 therapy include a 6 to 12 month benefit on overall survival, as the data suggests. This signal has generated excitement, and the company is eager to see the progression of trials that will define the role of Trop-2ADC in relation to PD-1 therapy. They are also interested in how data evolves from outside studies and how it informs the design of future phase 3 combination trials with their lenvatinib asset.
Q:How is the market feedback for the launch of the flu vaccine in the United States, as well as the potential acceptance for the RSV season?
A:The company feels positive about the launch of influenza vaccine in the United States and the progression of the season. Although the full approvals were received a few weeks later than initially expected, which impacted the timing, there was an initial stocking of $75 to $79 million, including a seeding order from the GAVI Alliance and other wholesaler or distributor stocking. As the season progresses into the following year, the company continues to see opportunities for this vaccine, which has benefits such as no weight-based dosing and the ability to look at total contract vaccines. Customer feedback has been very good, and the company looks forward to an impact this season and even more next year.
Q:What is the proportion of sales from early-stage settings and which of the 10 approved therapies is driving revenue?
A:The text does not provide specific details on the proportion of sales from early-stage settings or which of the 10 approved therapies is driving revenue. An update on Katru and the revenue contribution from early-stage settings was requested but not provided in the given text.

Merck & Co., Inc.
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