The paragraph introduces the Regeneron Pharmaceuticals Third Quarter 2024 Earnings Conference Call, with Shannon as the operator and Ryan Crowe from Investor Relations beginning the presentation. Key company figures, including Dr. Leonard Schleifer, Dr. George Yancopoulos, Marion McCourt, and Chris Fenimore, are present. The call will include prepared remarks followed by a Q&A session. Ryan Crowe notes that remarks may include forward-looking statements about the company and outlines the risks and uncertainties associated with such statements. An archive and transcript will be available on Regeneron's investor relations website after the call.

The paragraph provides an update on Regeneron's financial performance and future plans. It mentions that Regeneron has filed its Form 10-Q for the third quarter of 2024 with the SEC, and it highlights significant revenue growth of 11% to $3.72 billion and 8% growth in non-GAAP earnings. Key contributors to this growth include higher Sanofi collaboration revenues, strong performance of Dupixent, and growth in Libtayo and EYLEA products. The paragraph also outlines the agenda for the call, including presentations from Dr. Leonard Schleifer, George, Marion, and Chris, who will discuss pipeline updates, commercial performance, and financial results. Dupixent's global revenues grew by 24% on a constant currency basis to $3.8 billion.

The paragraph provides an update on the financial and market performance of Dupixent and EYLEA. Dupixent's global revenues are exceeding $15 billion annually, covering over 1 million patients across various indications, including recent FDA and Chinese approval for COPD treatment. The drug's ongoing launches are expected to drive growth beyond 2025. Meanwhile, EYLEA and EYLEA HD together reported $1.54 billion in sales, with EYLEA HD making notable gains in the US market. The paragraph highlights efforts to increase EYLEA HD's market share despite competition, emphasizing its distinct clinical profile. Additionally, upcoming pipeline developments are anticipated to offer future growth opportunities.

The paragraph outlines the company's expectations and upcoming milestones in their research and development pipeline. By the end of the year, interim Phase II data for a lung cancer treatment combining fianlimab and Libtayo, as well as proof-of-concept data for Factor XI antibodies in thrombosis, will be shared to guide Phase III plans. Looking ahead to 2025, results from the pivotal AERIFY studies for itepekimab in COPD for former smokers are anticipated, along with research on improving weight loss quality in obese patients on semaglutide through myostatin and Activin A blockade. Pivotal data for fianlimab-libtayo in metastatic melanoma may support regulatory filings. Updates on reversing severe food allergies using linvoseltamab and Dupixent are also expected. Overall, the pipeline consists of about 40 programs across diverse therapeutic areas, which are key to driving shareholder value. The company's antibody platform and genetic database offer a competitive edge. The section concludes with George Yancopoulos discussing EYLEA HD data in diabetic macular edema.

The paragraph discusses findings from an extension study on EYLEA HD, highlighting its ability to maintain vision gains and anatomical improvements over three years. Patients switched from standard EYLEA to EYLEA HD experienced slower retinal fluid re-accumulation and longer dosing intervals, with 83% extending to at least 12 weeks after one year on EYLEA HD. In the Photon trial, nearly half the participants were able to extend dosing intervals to at least 20 weeks after three years. EYLEA HD demonstrated a notably slower fluid re-accumulation compared to other anti-VEGF agents and maintained a safety profile consistent with earlier trials. These results suggest EYLEA HD has a best-in-class profile with longer dosing intervals and effective fluid management in its category.

The paragraph highlights recent achievements of Dupixent, including its approval as the first biologic treatment for COPD with an eosinophilic phenotype in the US, marking its sixth approved indication in the country. It discusses the upcoming pivotal results for Itepekimab, an interleukin-33 antibody that could treat COPD in former smokers if approved. Furthermore, the Phase III ADEPT trial for Dupixent in bullous pemphigoid showed significant success in disease remission, potentially supporting global regulatory approvals. Additionally, a second Phase III study confirmed Dupixent's efficacy in biologic-naive patients with chronic spontaneous urticaria.

The study on Dupixent showed it met its primary endpoint, with significant reductions in itch and urticaria scores and a higher complete response rate compared to placebo in treating chronic spontaneous urticaria (CSU). This data, along with previous studies on biologically naive patients, supports a supplementary BLA resubmission anticipating FDA approval for the first CSU-targeted therapy in a decade. On oncology, Libtayo demonstrated promising five-year overall survival results as a first-line treatment for advanced non-small cell lung cancer, nearly doubling median survival compared to chemotherapy. Additionally, updated data from a trial combining Libtayo with a LAG-3 antibody in advanced melanoma showed strong and deepening tumor responses.

The paragraph discusses a post-hoc pooled analysis of the fianlimab-libtayo combination therapy, which showed promising results in melanoma patients. The therapy achieved a 25% complete response rate, nearly double that of anti-PD-1 monotherapies, and resulted in a median progression-free survival (PFS) of 24 months—over five times greater than previous treatments. The combination therapy was particularly effective in patients who had previously undergone anti-PD-1 therapy in adjuvant or neoadjuvant settings. While showing a generally consistent safety profile with libtayo monotherapy, there was a noted increase in treatment-related adrenal insufficiency. Despite past disappointments with combining checkpoint inhibitors, these results suggest additive clinical benefits. An ongoing Phase III trial comparing this combination to pembrolizumab monotherapy is anticipated to provide pivotal data next year.

The paragraph discusses the exploration of a combination therapy in various cancers responsive to anti-PD-1 therapy, including lung cancer, with Phase II data expected by the end of the year. It highlights the European Commission's approval of Ordspono (odronextamab), a CD20xCD3 bispecific antibody for certain lymphomas, marking the first approval from their bispecific platform. They are working on confirmatory studies to support resubmission of their BLA for follicular lymphoma by the first half of 2025. The paragraph also mentions linvoseltamab, a BCMAxCD3 bispecific for multiple myeloma, which shows promising efficacy and safety data. The clinical development program aims to evaluate odronextamab and linvoseltamab as monotherapies and in limited combinations, contrasting with competitors who explore more combination therapies. Specific studies like the Phase III OLYMPIA 1 and Phase I/II LINKER MM4 are also mentioned.

The article discusses the progress of several medical studies and programs. It highlights ongoing Phase II studies of linvoseltamab monotherapy in conditions that could lead to myeloma, as well as advances in their non-oncology hematology pipeline. This includes a novel C5 program combining an antibody and siRNA targeting the same protein, with potential indications for Paroxysmal Nocturnal Hemoglobinuria and Myasthenia Gravis. Initial patient screening has begun for a Phase III program targeting geographic atrophy in dry age-related macular degeneration. The systemic approach aims to reduce risks associated with current treatments and offer treatment for bilateral disease. Additionally, they are on track to report results from studies on Factor XI antibodies for venous thromboembolism prevention after knee surgery, with potential advancement to Phase III trials.

The paragraph highlights Regeneron's successful third-quarter performance, emphasizing advancements in their product pipeline, particularly in areas like oncology and immunology. It notes a 3% year-over-year increase in combined US net sales of EYLEA HD and EYLEA, totaling $1.54 billion, despite fluctuations in wholesaler inventory levels. EYLEA HD, specifically, saw a 29% sequential growth, capturing 44% of the total anti-VEGF category due to its durability, efficacy, and safety. Recent data suggests EYLEA HD's strong clinical potential, positioning it as a leading option in the field.

The paragraph discusses the success and future plans for three pharmaceutical products: EYLEA HD, Libtayo, and Dupixent. EYLEA HD has achieved billion-dollar brand status and aims to strengthen its position with new product features and indications by 2025. Libtayo saw a 24% increase in global net sales, largely driven by growth in the US and aims to expand its market share, particularly in non-melanoma skin cancer and lung cancer. Dupixent continues its strong growth, with global net sales reaching $3.8 billion, marking a 24% increase year-over-year, and has surpassed 1 million patients across seven indications worldwide. The company looks forward to further growth in 2025 with new launches and regulatory updates.

The paragraph discusses the strong performance and expanding usage of Dupixent in the US market. Net sales increased by 19% year-over-year, with Dupixent being the leading biologic for new patients across its approved indications, including atopic dermatitis, asthma, and nasal polyps. The drug's mechanism targets IL-4 and IL-13 to address type 2 diseases, and demand remains high. New prescriptions for prurigo nodularis and eosinophilic esophagitis (EOE) have risen significantly. Recently, Dupixent's approval expanded to include patients as young as 12 with chronic rhinosinusitis with nasal polyps. Additionally, it's been approved for treating COPD in over 30 countries, with a potential benefit for over 300,000 US patients. Educational and access efforts are ongoing to support physician prescribing and patient engagement, particularly focusing on type 2 inflammation in COPD, with significant progress in securing Medicare reimbursement.

The paragraph discusses Regeneron's growth potential and financial performance. Dupixent is expected to drive significant growth, particularly with its anticipated launch for COPD in Japan, pediatric EoE in the EU, and chronic spontaneous urticaria in the US. The commercial team aims to expand access to Regeneron medicines globally. Financially, Regeneron saw strong performance in the third quarter, with an 11% increase in total revenues to $3.7 billion, largely due to higher Sanofi collaboration revenues and US growth for Libtayo and EYLEA. Third-quarter net income grew by 8% to $1.5 billion, with significant profits from their collaboration with Sanofi, particularly from Dupixent.

In the third quarter, Sanofi's development balance decreased by $200 million, reaching $1.8 billion, and Bayer's ex-US net sales for EYLEA increased by 9% to $932 million. Total collaboration revenue with Bayer was $391 million. Inmazeb sales amounted to $35 million, with expectations for 2024 to match 2023's $70 million. Other revenue was $114 million, projected to increase sequentially in the fourth quarter of 2024 but remain lower than 2023 overall. R&D expenses rose to $1.1 billion due to ongoing pipeline investments, while SG&A expenses grew by 15% to $613 million. Gross margins declined slightly to 89%. Regeneron generated $2.6 billion in free cash flow in the first nine months of 2024, ending the quarter with a net cash position of $15.6 billion and repurchased $1.6 billion of shares, with $738 million in the third quarter.

The paragraph discusses Regeneron's financial outlook and strategies. The company emphasizes share repurchases as an efficient use of capital, with $2.9 billion available for such actions as of the third quarter's end. Minor adjustments were made to the 2021 financial guidance based on year-to-date results, with detailed 2024 guidance provided in a recent press release. Regeneron reports strong financial performance for the third quarter, highlighting continued investments for long-term growth. During the Q&A session, a question is raised about the future of EYLEA, particularly in light of Amgen's biosimilar launch. Leonard Schleifer responds by underscoring EYLEA's strong track record, with over 100 million injections, emphasizing its proven performance and safety, which have fostered confidence among physicians and patients.

The paragraph discusses the performance and competitive landscape of EYLEA HD, highlighting its differentiation and the ongoing efforts to educate doctors about its benefits. Despite the presence of a biosimilar for EYLEA, the company is confident in competing effectively. Tyler Van Buren asks about the expected quarter-over-quarter growth for EYLEA HD despite negative impacts from wholesaler inventory and if there's any positive effect from the removal of a competing product. Marion McCourt responds that they observed growth and have strong confidence in EYLEA HD due to its product profile and clinical data. Additionally, she mentions a favorable impact of approximately $40 million from increased wholesaler inventory levels, though no specific fourth-quarter guidance is provided.

In the paragraph, Leonard Schleifer and Marion McCourt discuss EYLEA's market strategy and future plans. Schleifer expresses confidence in the performance of EYLEA HD, despite current lower inventory levels, and anticipates that the introduction of a prefilled syringe by mid-next year will boost growth. They emphasize ensuring the new product's safety to avoid issues like inflammation, which can lead to serious eye conditions. McCourt highlights that their team is aware of Pine's withdrawal of support for Avastin, and they are actively supporting retina offices as challenges arise, noting that some Avastin inventory remains in the market.

The paragraph discusses the anticipation of launching a prefilled syringe version of EYLEA HD by the middle of next year, with Bayer planning to introduce a similar device outside the United States. Although the product's development timeline has been pushed back due to additional requirements in the U.S., there is confidence in a differentiated market opportunity, as there is a preference for prefilled syringes among customers. The conversation involves Ryan Crowe, Leonard Schleifer, and comments from analysts Brian Abrahams and Carter Gould, who inquire about the potential use increase and development factors.

In the paragraph, Leonard Schleifer discusses Regeneron's approach to research and development (R&D) investments and capital allocation amidst potential market changes, such as Amgen's actions. He emphasizes that Regeneron's priority is to innovate and bring new products to market rather than focus on biosimilars. With over 40 products in clinical development, many in Phase III, Schleifer indicates that the company will invest based on the opportunities seen rather than external factors like biosimilar entry. Regeneron has a strong financial position and robust R&D capabilities, which supports continued investment in future product development. He expresses optimism about their future given their past successes but acknowledges that past performance does not guarantee future results.

In the paragraph, George Yancopoulos from a company discusses the excitement around their Factor XI program, which aims to innovate in the field of coagulation treatment. They are developing two different antibodies, the A2 domain antibody and the catalytic domain antibody, each with distinct approaches and expected outcomes. The A2 domain antibody is anticipated to have a milder safety profile with moderate effects on coagulation, while the catalytic domain antibody is expected to provide superior coagulation control but with a potentially higher safety risk. The company plans to assess both treatments in ongoing clinical trials to determine their effectiveness and safety, and will consider advancing them into a Phase III program based on these results. The goal is to identify different potential medical indications for each antibody.

The paragraph discusses a conversation about the effectiveness and competitive advantage of Regeneron's antibodies in treating coagulation issues compared to other Factor XI antibodies and small molecule competitors. Leonard Schleifer highlights the in-house pharmacodynamic data that suggests Regeneron's antibodies outperform others. The discussion transitions to Christopher Raymond's question concerning the supply and quality issues with compounded Avastin, with a KOL suggesting these issues may mark the beginning of the end for Avastin. Raymond then asks if this situation could lead to more opportunities for biosimilar options.

The paragraph discusses the impact of prior Avastin shortages on medical practices, leading to decreased confidence in its supply. Marion McCourt highlights the competitive nature of the anti-VEGF market and positions EYLEA HD and EYLEA as strong contenders. Salveen Richter from Goldman Sachs inquires about pricing pressures on EYLEA HD and their relation to biosimilars. McCourt responds by acknowledging that pricing pressures affect all products in the category but emphasizes that physicians' preference is driven by their experience, safety, efficacy, and the durability of products like EYLEA HD.

In the paragraph, the discussion centers on the performance and growth potential of EYLEA, particularly in the anti-VEGF category. The response highlights that EYLEA is experiencing pricing pressures, likely due to its long market presence, and emphasizes the differentiation and benefits of EYLEA HD, such as its clinical profile, durability, and supporting clinical data. Regarding uptake, they refrain from providing specific guidance but express optimism for future catalysts, including potential approval for RVO and the introduction of a prefilled syringe, which could accelerate EYLEA's adoption next year.

The paragraph involves a discussion about an ongoing Phase II obesity study focusing on the combination of trevogrumab and garetosmab. The trial's size was increased from 620 to over 1,000 participants, with three new investigational arms added. George Yancopoulos explains that the expansion was primarily to include additional dosing arms for exploring different doses of the potential muscle-enhancing treatments. This enlargement aims to gather broader information on the effects of these treatments on muscle preservation.

The paragraph discusses the challenges and considerations related to weight loss treatments, particularly those involving GLP-related agents like semaglutide. It highlights the concern about significant lean body and muscle loss, which can account for 30-40% of the weight loss and may become problematic as patients often stop and restart treatments, leading to cumulative muscle loss. George Yancopoulos emphasizes the importance of maintaining muscle mass to prevent this issue, noting that muscle is a key factor in energy expenditure and can increase metabolic rate when preserved. The regulatory environment for muscle-preserving or building treatments is also mentioned, with the FDA historically cautious in this area.

The paragraph discusses a weight loss approach that focuses on increasing calorie expenditure by building or preserving muscle, which helps improve body composition. The strategy aims to satisfy regulatory requirements primarily through demonstrating increased weight loss, while also potentially showcasing better body composition. It mentions ongoing discussions with regulatory agencies about using metabolic and functional endpoints, which might require more extensive studies. The ultimate goal is to maintain muscle while achieving significant weight loss. Additionally, it highlights the development of Unimolecular solutions designed to address these objectives within a single molecule.

The paragraph is a transcript from a conference call where David Risinger from Leerink Partners asks about Regeneron's efforts to develop a next-generation version of Dupixent, with a focus on less frequent administration. George Yancopoulos from Regeneron responds by stating that the company is continually working on both improving existing products, like those in the Dupixent class, and developing entirely new approaches. In the next part, William Pickering from Bernstein asks about the potential impact of biosimilar competition on EYLEA, comparing it to the erosion experienced by Lucentis. Marion McCourt from Regeneron remarks that it's too early to comment on that issue.

The paragraph discusses the confidence in the EYLEA product and mentions the introduction of EYLEA HD as an alternative for patients. Cory Kasimov from Evercore ISI asks about the company’s capital allocation priorities, specifically regarding share repurchasing and the potential for a dividend, given their significant cash reserves. Leonard Schleifer explains that while they have ongoing discussions on these topics, they have no new information to share publicly. He notes that considering a dividend might be more appropriate once their development balance to Sanofi is paid off by the end of 2026. Decisions around stock repurchasing are not disclosed until they occur.

The paragraph is a closing statement from a Regeneron conference call, thanking participants for their interest and apologizing to those who didn't get their questions answered. It mentions that the Investor Relations team is available for further inquiries and concludes with holiday wishes for Halloween and Diwali before the operator ends the call.

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