礼来公司 (LLY.US) 2025年第三季度业绩电话会
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会议摘要
Eli Lilly & Co. reported a 54% revenue growth in Q3 2025, driven by strong performance in immunology, oncology, neuroscience, and cardiometabolic health products, particularly Monjaro. The company secured FDA approvals for new drugs, advanced phase 3 trials for obesity, diabetes, and Alzheimer's treatments, and expanded manufacturing with new facilities. Financially, it raised guidance, with non-GAAP margins expected at 45%-46% of revenue, and distributed $1.3 billion in dividends, executing $700 million in share repurchases. Lilly's strategy focuses on innovation, market expansion, and global product launches to enhance patient outcomes.
会议速览
A conference call discusses Lily's Q3 2025 earnings, focusing on non-GAAP financial measures, forward-looking statements, and product pipeline, with executives from various departments participating.
Q3 marked significant progress for Lilly, with a 54% revenue increase, market share growth in insulin analogs, and Manjaro's global uptake acceleration. The company also advanced its pipeline and expanded manufacturing, leading to raised revenue and earnings per share guidance.
Announcement of FDA and EU approvals for various drugs, positive phase 3 trial results, and plans for new US manufacturing facilities. Distribution of $1.3 billion in dividends and $700 million in share repurchases. Progress in manufacturing expansion with new facilities in Virginia, Texas, and Puerto Rico. Updates on remaining new US manufacturing facilities to be announced soon.
Q3 revenue surged 54% year-over-year, with gross margin increasing to 83.6% due to a favorable product mix. Strategic investments in R&D and marketing fueled expense growth, yet the non-GAAP performance margin rose to 48.3%, driven by robust revenue expansion. Earnings per share reached $7.02, bolstered by operational gains and a one-time milestone payment, despite a price decline.
ATS in immunology shows robust growth in atopic dermatitis prescriptions, while cper in oncology gains momentum with new phase 3 trial data. Vasenin maintains leadership in high-risk early breast cancer market, reflecting standard of care status.
Prescription volumes grew in the US and internationally, with neuroscience and metabolic health products showing significant market share gains. The company received European marketing authorization and anticipates launches in 2026. Strong global performance in Manjaro and robust uptake in obesity markets, despite limited reimbursement, highlight high clinical need. Financial expectations are updated with a revenue increase forecasted for 2025, driven by underlying performance and favorable foreign exchange rates.
Lucas Lily RG reports significant advancements in obesity and type 2 diabetes treatments, including successful trials for attain 2 and orpo glycta, with global regulatory submissions anticipated and a launch in the US for obesity treatment next year. Positive phase 3 diabetes trial results support orpo glycta's potential as a foundational therapy, with submission expected in H1 2026. Ongoing trials explore additional applications, including osteoarthritis pain and stress-related conditions.
The dialogue discusses a groundbreaking phase 3 study on maintaining weight loss after switching from injectable semaglutide to oral medications, aiming to measure efficacy in patients previously treated for 72 weeks. It also highlights the upcoming phase 3 studies for a novel GLP-1 glucagon triple agonist, Reditu Ti, expected to deliver deeper and faster weight loss than existing medicines, particularly for patients with high BMI or obesity-related complications, with results anticipated by 2026.
The Triumph program is set to deliver top line results from its first phase 3 trial comparing re-directed to placebo in obesity and knee osteoarthritis pain, with more trials planned for 2026 and 2027. Additionally, a phase 3 study for Move Alain, a small molecule inhibitor of lipoprotein A, has been initiated for patients with elevated LPA levels and atherosclerotic cardiovascular disease. Updates also include the submission of once weekly insulin for type 2 diabetes and plans for phase 3 trials with bacini B in type 1 diabetes. Phase 2 data from a selective amylin agonist will be presented at Obesity Week in November.
Received FDA approval for Inland Erant under brand name Inl'Ore, targeting advanced breast cancer. Ongoing Phase 3 Ember 4 trial with 8,000 patients evaluates Inland Erant in high-risk early breast cancer, expected full enrollment by early 2026. Positive Phase 3 results from Bruin CLL 313 trial showed significant improvement in progression-free survival with proto-brutinel compared to chemoimmunotherapy in treatment-naive CLL patients. Presented updates at ESMO on early-stage oncology portfolio, including mutant-selective PI3Kα inhibitor, fully receptor α antibody drug conjugate, and FGFR3 selective inhibitor, planning Phase 3 trials for these medicines by 2026.
The EU, US, and Japan have approved Cassano with modified trittau dosing, reducing Aria risks. Phase 3 trials for tna-tulf in Alzheimer's and bnat type in alcohol use disorder are advancing, alongside exploring opioid use disorder. Immunology sees lebrikizumab's dosing flexibility for atopic dermatitis, with FDA submission pending. Combination therapies for inflammatory diseases are in early stages, with data expected soon.
The dialogue highlights the company's progress in 2025, with a focus on the clinical portfolio updates, upcoming milestones, and strong execution in driving business results. It also outlines the Q&A session format for the call.
The dialogue discusses Orphalan Lipro's market entry strategies, including potential FDA approval and the National Priority Review Voucher program, aiming for a swift global launch, with a focus on US patients.
A detailed discussion on the impressive sales growth of Manjaro International over the past two quarters, including insights into new country launches, their performance relative to expectations, and strategies for sustained growth from a new higher base, along with considerations regarding potential stockpiling effects.
The dialogue highlights Lu International's growth outside the U.S., emphasizing strong performances in countries like China, Brazil, Mexico, and India. It discusses opportunities in type 2 diabetes and obesity markets, the importance of patient activation, and the challenges of reimbursement and market dynamics across 55 countries.
Discussion on M&A behaviors, market segmentation, and competitive strategies in healthcare. Insights on how different companies are targeting specific patient populations and market segments, and the implications for market leadership.
A speaker discusses the company's robust obesity treatment portfolio, highlighting its strong R&D engine and leading molecules. Despite competition, the company remains confident in its position, backed by ongoing investments in R&D and clinical trials, aiming to maintain its lead in the obesity treatment space.
Discusses the importance of balancing innovation with execution in a large-scale pharmaceutical business, emphasizing the need to maintain leadership through strategic focus on both innovation and operational excellence, while anticipating competitive dynamics in the industry.
Discussion on how replacing drug rebates with GTO fees may lead to greater discounts, more employer op ins, and potential GTN pressure, impacting clinical profiles and access to medications.
Speakers commend Signa's initiative to shift healthcare towards a transparent, value-based model, benefiting innovators, patients, and payers. They highlight the move's potential to reduce out-of-pocket costs, recognize the value of medicines, and encourage competition based on clinical differentiation. The speakers express hope for broader industry adoption, emphasizing the importance of recognizing valuable medicines and discouraging less valuable ones through fair pricing mechanisms.
Discussed the dual approach to commercial strategy, emphasizing broad patient access and consumer-centric platforms alongside traditional payer negotiations, aiming to reduce healthcare system barriers.
A discussion highlighted the completion of enrollment in an Alzheimer's clinical trial, emphasizing the importance of early treatment and the need for a simple blood test for diagnosis. The conversation also touched on readiness for trial results and ongoing innovation in Alzheimer's research, including new dosing formulations and accessible diagnostic methods.
The dialogue discusses the evolving landscape of Alzheimer's disease treatment, highlighting the potential benefits of GLP-1 receptor agonists with neural properties. It emphasizes the company's leadership in incretin therapy and appetite regulation, expressing anticipation for forthcoming data that could inform future strategies in CNS indications, including Alzheimer's, with plans to detail next steps.
A discussion on preparing for a large-scale patient support program with a capacity for 5 million patients, focusing on market expansion potential and concerns regarding initial launch dynamics.
Discussion highlights Orcofi Pro's potential in obesity and diabetes, emphasizing its efficacy, safety, and ease of use. Plans include global market expansion, exploring new indications, and maintaining patient success post-treatment.
Discusses the impact of pricing on volume dynamics in the obesity market, highlighting rapid growth in cash pay channels and lessons learned from price elasticity in the UK, aiming to inform future market entry strategies.
The dialogue highlights the strategic importance of enhancing patient access to medicines like Zebon and Orphaglip through various channels, including retail outlets. It also discusses the implications of price adjustments in the UK market, revealing consumer pricing elasticity and the potential for scaling obesity treatments with specific patient needs in mind. The focus remains on improving health outcomes by leveraging multiple medicines and platforms.
Discussion revolves around the potential impact of a negotiated price for a drug, affecting Medicare Part D, on the pricing and market positioning of pharmaceutical products. Emphasis is placed on the superior efficacy of newer drugs, which could influence payer discussions and market preferences, suggesting a strategic advantage despite potential pricing changes.
The Attain Maintain trial, a first-of-its-kind study, aims to demonstrate Orford Libros' efficacy in weight maintenance, potentially expanding its market by providing a simple, once-daily oral option. The outcome could significantly influence the speed and scale of the drug's commercial launch, emphasizing its role in helping patients transition from other weight management drugs.
A discussion on GT pricing and market competition reveals stable pricing performance post-CVS move, with no significant erosion. The analysis highlights maintained pricing strategies and market penetration efforts, suggesting no material change in competitive dynamics.
Discusses the dual objective of maintaining innovation incentives while ensuring global accessibility of obesity treatments through strategic pricing and indication expansion, highlighting the unique role of consumer self-pay in the GLP-1 category.
A scientist expresses continued enthusiasm for a presymptomatic Alzheimer's treatment program, citing significant treatment effects in early-stage patients from previous trials. Anticipates similar success in upcoming trials, Trailblazer 3 and Trail Runner 3, maintaining high expectations for the program's potential.
A conference ends with thanks to participants, emphasizing the importance of their engagement and providing access to the replay for future reference.
要点回答
Q:What were the financial results for Eli Lilly's Q3 2025?
A:Eli Lilly's Q3 2025 revenue grew 54% compared to the same period last year, driven by key products. The non GAAP performance margin was 48.3%, with earnings per share at $7.20, inclusive of certain charges.
Q:What are the recent milestones achieved by Eli Lilly?
A:Recent milestones include FDA approval for Lumi stent under the Bram name in lurio for HR positive, her2 negative ESR1 mutated, advanced or metastatic breast cancer; EU approval for Cassandra for early symptomatic Alzheimer's disease; positive phase 3 trial results of jpca in naive Cllr positive overall survival data for rosanio in high risk early breast cancer; and the start of global submissions for GoPro in obesity.
Q:How did the revenue growth compare across different regions for Eli Lilly?
A:Revenue growth in the US was driven by volume increases of zban and monjaro, despite a 15% price decline. Europe's revenue increased by over 100% in constant currency, while revenue grew by 24% in Japan, 22% in China, and 51% in the rest of the world, all driven by monjaro volume growth.
Q:What updates were provided on key products for Eli Lilly?
A:Key products performed as follows: Immunology showed strong performance with a 41% increase in atopic dermatitis prescriptions, with the first line setting accounting for over 50% of new patients. In oncology, cper gained market share with new data from phase 3 trials. In neuroscience, kisona prescriptions grew 50% and continue to increase market share. In cardio-metabolic health, both 7 and monjaro achieved global strong performance, with Manjaro showing robust performance in 55 countries and significant share gains in most major markets.
Q:What is the impact of recent regulatory changes on Eli Lilly's performance?
A:The impact of the CVS formulary change was modest, with share of total US prescriptions in the brandy and the obesity market declining by approximately 2 percentage points. However, performance returned to Q2 levels and the brand exceeded Q3 with 71% share of new prescriptions. The uptake of 7 in BIOS was significant, comprising 30% of total UCB1 prescriptions and over 45% of new prescriptions in Q3.
Q:What guidance was provided for Eli Lilly's 2025 financial results?
A:Eli Lilly increased the midpoint of their revenue range by over $2 billion, anticipating full year revenue between $63 and $63.5 billion. The non GAAP performance margin is expected to be between 45 and 46% of revenue, and the company has increased their outlook for non-GAAP earnings per share to be between $23.60 and $23.70.
Q:What was the progress in Eli Lilly's research and development?
A:Eli Lilly's research and development progress includes three trials for obesity and type 2 diabetes, with one trial completed and the clinical package required to initiate global regulatory submissions for the treatment of obesity. The submissions are expected to begin imminently, with plans to launch or for glib in the US for treatment of obesity next year.
Q:What is the potential role of or four glyph on in the treatment of type 2 diabetes?
A:The potential role of or four glyph on in the treatment of type 2 diabetes includes it being a foundational treatment, with successful completion of phase 3 trials and an anticipated submission for treatment of type 2 diabetes in the first half of 2026.
Q:What are the outcomes of the Q 5 study regarding or four glyph on?
A:The Q 5 study outcomes indicate that or four glyph Ro may provide benefit as an add-on therapy to titrated insulin glarg. This is supported by consistent safety and tolerability overall observed in or for glip trials.
Q:What is the purpose of the phase 3 study 'attain, maintain'?
A:The purpose of the phase 3 study 'attain, maintain' is to measure the impact of switching from injectable semaglutide or injectable to zepatier to oral or for glyph rock and to measure the level of weight loss patients can maintain after the switch.
Q:What are the expectations for the red, a true guide program by the end of 2026?
A:The expectations for the red, a true guide program by the end of 2026 are that it will provide results from up to six phase 3 studies to support the obesity and related complications program called Triumph and the Type 2 diabetes program called Transcend.
Q:What is the focus of the global development program for re-directed?
A:The focus of the global development program for re-directed is on patients with a high degree of obesity or obesity-related complications, where the clinical needs are the highest, despite a broad range of Bmis.
Q:What are the details of the first trial to read out, Tri 4?
A:The details of the first trial to read out, Tri 4, are that it compares re-directed to placebo in patients with obesity and knee osteoarthritis pain. It is a 68-week study designed primarily as a pain relief study to support an indication for treatment of knee osteoarthritis pain.
Q:What has been initiated based on phase 2 data with LPA?
A:Based on phase 2 data with LPA, a phase 3 study has been initiated called Move LPA trial, which is focused on people with elevated LPA levels and atherosclerotic cardiovascular disease.
Q:What was the outcome of the positive phase 3 trial in the BTK inhibitor program?
A:The outcome of the positive phase 3 trial in the BTK inhibitor program was a highly statistically significant and clinically meaningful improvement in progression-free survival for the patients.
Q:What is the next study to read out in neuroscience, and what is the potential of the new compound bnat type?
A:The next study to read out in neuroscience will be the phase 3 program in alcohol use disorder with bnat type. The potential of the new compound bnat type is that it could have the optimal properties for neuroscience indications and is showing emerging clinical profiles in studies.
Q:What is the current status of lebrikizumab in clinical trials for atopic dermatitis?
A:Lebrikizumab has been presented with new data showing durable disease control in people with moderate to severe atopic dermatitis. These data have been submitted to the FDA for a potential label update and there are plans to explore even less frequent dosing.
Q:What are the company's expectations for the launch timeline and the potential impact on 2026 consensus expectations?
A:The company is ready to launch the product in the quarter and hopes for approval soon after. They intend to pursue an all-encompassing strategy to get the medicine to market quickly. As a result, investors can expect the company to submit the package for review in the quarter, with hopes of approval shortly thereafter, which could impact consensus expectations for 2026.
Q:What is the current trend of Manjaro International sales and how are new country launches performing?
A:Manjaro International has experienced significant growth in sales over the past two years, with notable steps up in the latest quarters. The company is encouraged by uptake in business outside of the U.S., with 75% out of pocket and 25% type 2 diabetes. Initial stocking occurred in major markets like China, Brazil, Mexico, and India in Q2, with strong performance in Q3 globally. Future growth opportunities include reimbursement in additional markets and patient activation, although the journey will take some time.
Q:How does the company view the competitive dynamics in the market, particularly with regards to M&A activities?
A:The company views the M&A behaviors in the market and the resulting dynamics as normal and expected. They are focused on their own business, innovation, and segmenting the market, while also working to maintain a strong leadership position. They see opportunities to improve their position and have not seen anything that changes their view on the competitiveness or their lead in the space.
Q:What is the company's position on the recent changes in drug rebate structures, such as the replacement of rebates with GTO fees?
A:The company welcomes the shift from drug rebates to GTO fees and other transparent pricing models. They believe this change will lead to greater discounts and employer cost-insurance, while also improving transparency and reducing out-of-pocket costs for patients. The company supports a basis of competition based on clinical differentiation, and this move away from hidden rebate systems is in line with their interests. They hope other payers follow this lead, and that it will lead to more value being recognized in pricing for innovative medicines.
Q:What is the commercial strategy for Orford lipro and how does it balance consumer-centric and traditional pharma approaches?
A:The company's commercial strategy for Orford lipro is multifaceted, combining consumer-centric approaches with traditional pharma methods. They plan to leverage both broad coverage and direct-to-consumer platforms to ensure access for all patients. They also intend to engage in negotiations with PBMs and payers to drive great commercial and access for patients. The goal is to satisfy both segments – consumers looking for solutions outside healthcare system friction and traditional pharma stakeholders.
Q:What are the updates on the Trailblazer L3 interim and its relevance to Alzheimer's prevention?
A:The Trailblazer L3 interim has been discussed by Lily in detail and the company has completed enrollment in this trial. The trial is event-based and its continuation depends on reaching a sufficient number of events. The company is looking forward to the results and is actively working on innovation in Alzheimer's space, including a sub two dosing formulation and a monthly S in with fixed duration dosing. There is a need for awareness, education, and a simple blood test for diagnosis in the preclinical space.
Q:What is the company's strategy for ensuring readiness for the readout in the clinical trials?
A:The company is focusing on several readiness actions to ensure it is prepared for the readout, which includes preclinical studies. They are emphasizing the importance of treating the disease in its early stage, being proactive in screening health, and the availability of a simple and accessible blood test for diagnosis. The company is making fundamental shifts in these areas to prepare for the trial readout.
Q:How does the company view the potential evolution of the GLP-1 field in Alzheimer's disease and the benefits of the new GLP-1RA drug?
A:The company views GLP-1 as having attributes that could be beneficial for Alzheimer's disease due to its potential for use in CNS indications. Although no specific plans have been laid out for this indication, the company anticipates that upcoming data will be very informative. Regardless of the outcome of the upcoming data, there are opportunities to build and create something more meaningful for patients.
Q:What are the potential market expansion opportunities for orlistat?
A:The potential for market expansion for orlistat is substantial. With six phase 3 studies completed, the company understands orlistat's profile as an emergent medicine that recapitulates the efficacy and safety of injectable GLP-1RAs. It can be taken as a simple once-daily pill without restrictions on food or water, which could potentially reach millions of people in the United States and hundreds of millions globally. The company aims to make it accessible to a larger group of people for the simplicity of its profile and ease of manufacture and distribution.
Q:What are the learnings from the UK regarding volume changes in response to price increases and how will it affect orlistat's launch strategy in the US?
A:The company learned from the UK that there is consumer pricing elasticity, with a shift in volumes when prices increase. This has implications for the orlistat launch strategy in the US, as it indicates the importance of considering the impact of prices on demand. The company also learned that for people with a DMI below 32.5, there is an opportunity to reach the orlistat market without the need for weight loss. This suggests a potential segment of the market that could be targeted with the new offering.
Q:How is the direct to consumer platform contributing to growth in the zeban market?
A:The direct to consumer platform has contributed to significant growth in the zeban market, with a sequential growth of 15% and an increase in volume through this channel. The platform addresses patient and provider perceptions of value and accessibility to medicine. Other factors include the ability to pick up Zetland VI at a local Walmart and plans to add another treatment like orlistat to expand patient access to treatments.
Q:What is the impact of the UK's price increase on orlistat's market dynamics?
A:The UK's price increase for orlistat has not negatively impacted the market, as expected. There was a stop in exports from the UK to other markets due to intervention, indicating that the company was able to manage any potential market disruptions effectively. The company is also gaining insights into consumer pricing elasticity, which is important for understanding the impact of price changes on demand for orlistat.
Q:What are the characteristics of the upcoming Attain maintained trial and its significance to Oram biosense's commercial opportunity?
A:The Attain maintained trial is described as a first-of-kin study that the company is looking forward to, with results expected later in the year. This study will involve patients who were maximally tolerated on either semaglutide 5 or triple therapy and will randomize them to either Oram biosense's orlistat or placebo, measuring the percentage of weight lost over 72 weeks. The significance to Oram biosense's commercial opportunity is that it provides an opportunity to expand the market for the company's GLP-1 drugs, with very bullish expectations for it as a first line starter medication, and to continue to grow the market beyond what is considered cannibalization, but rather viewed as an opportunity to attract more patients.
Q:What are the pricing dynamics of the GLP-1 category and how has the competition impacted or influenced pricing strategies?
A:The pricing dynamics of the GLP-1 category have been discussed in the context of performance and expectations. The performance continues to meet the expectations set by the company. In the context of competition, the company notes that it pays close attention to competitors but differentiates itself commercially and product-wise. The company has maintained a strong pricing strategy over the past 26 months, and despite a large number of doses produced for orlistat, there is no apparent impact on pricing. The differentiation and the consumer self-pay channel have been mentioned as factors influencing pricing strategies. The company's strategy is to offer compelling prices for consumers while also building out indications for chronic diseases. The unique dynamics of the GLP-1 category, where there is a high probability of consistent benefits and very few non-responders, have contributed to a situation where the company can both offer strong consumer pricing and compete for healthcare dollars from governments or private payers. The company is committed to achieving both objectives and is excited about the potential to reach tens or even hundreds of millions of people with GLP-1 treatments in the coming years.
Q:What are the expectations and potential impact of the pricing model between the US and the rest of the world on orlistat and the obesity treatment market?
A:The expectations regarding the pricing model between the US and the rest of the world on orlistat and the obesity treatment market hinge on the strategy of flatter pricing. This strategy is believed to be important for continuous innovation and for making orlistat accessible to hundreds of millions of patients. The potential impact of this pricing model is to foster global health benefits and to allow the company to compete for healthcare dollars from governments and private payers. The company's strategy is to have a strong consumer offering and to prove the health benefits of the medicine, which should not compete for consumer dollars but for healthcare dollars. The company's goal is to bridge the gap between the US and other developed countries, as well as to continue offering compelling prices for consumers while exploring new classes of treatments.
Q:How does the consumer self-pay channel differ in the GLP-1 category and what are the implications for pricing and access to the medicine?
A:The consumer self-pay channel in the GLP-1 category is unique as it has not scaled in other categories due to the consistent benefits seen with these medicines, resulting in very few non-responders. This short-term effect, coupled with long-term health benefits, makes the situation desirable. The implication for pricing and access is that the company has experienced price elasticity and is in a position to offer consumers an affordable price for self-pay while also focusing on building out indications for chronic diseases. The company aims to compete with other classes of medicines and chronic diseases or even create new classes while continuing to see consumer self-paying demand for prevention and other needs.
Q:What drives the company's excitement about its presymptomatic Alzheimer's program and how has the view on this program changed since its initiation?
A:The company's excitement about its presymptomatic Alzheimer's program stems from data observed in previous trials where the largest treatment effect was seen in patients with the earliest disease course. This effect was also observed in prevention of progression as an outcome. The program's potential to treat in the preclinical space has remained consistent, with the same level of enthusiasm since the program's initiation. The company expects to see profound results in the ongoing trials and is extremely excited about the potential of the program.

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