The operator welcomes participants to the Regeneron Pharmaceuticals First Quarter 2024 Earnings Conference Call and introduces the speakers. The call will be recorded and an archive will be available on the company's website. The speakers include the CEO, CSO, EVP of Commercial, and CFO. The call may include forward-looking statements about the company's products, finances, development programs, collaborations, and other matters, which are subject to risks and uncertainties.

Regeneron's first quarter financial results were strong, with a 7% increase in revenues after excluding last year's COVID antibody revenues. This growth was driven by Sanofi collaboration revenues and Libtayo global net product sales, which grew by 14% and 45%, respectively. The company's President and CEO, Dr. Leonard Schleifer, discussed some of the key performance drivers and highlighted the potential of their differentiated development programs to drive long-term growth and value for shareholders. The pipeline update, commercial performance, and financial results were also discussed by other members of the company.

The paragraph discusses the financial success of Dupixent and EYLEA HD, two drugs developed by Regeneron and Sanofi. It also mentions the potential for Dupixent to be approved for the treatment of COPD with Type 2 inflammation, pending additional analyses requested by the FDA. The companies are confident in the potential of Dupixent to transform the treatment paradigm for COPD patients and are preparing for a launch if approved.

There is a high unmet need for COPD treatment with Type 2 inflammation, and the company is on track to report results and seek regulatory approvals for their IL-33 antibody, itepekimab. This antibody has the potential to address up to 1 million patients in G7 countries and China. The company also sees potential in combining their severe allergy drug, linvoseltamab, with Dupixent to address severe allergies and multiple myeloma. They believe linvoseltamab has the potential to be a best-in-class option due to its high response rates, shorter hospital stay, and less frequent dosing compared to other drugs in its class.

The company has over 35 programs in clinical development and is excited about the opportunities in their pipeline. They have a strong commercial team and are focused on driving shareholder returns. They are also working on a combination treatment for severe allergies using a bispecific antibody and Dupixent. They have started a proof of concept trial for this treatment and hope to see initial results later this year. They are also exploring combinations of Libtayo in oncology.

The early clinical results of the LAG-3 antibody, fianlimab, in combination with Libtayo have shown promising potential for best-in-class efficacy in first-line metastatic melanoma. The combination has demonstrated an objective response rate of approximately 60% and a safety profile similar to anti-PD-1 monotherapy. A Phase 2/3 study of the combination is enrolling faster than expected and will now be conducted solely as a Phase 3 study, with results expected in 2025. The company also received complete response letters from the FDA for their CD20xCD3 bispecific, odronextamab, but intends to address the issue and expects a decision from the EU in the second half of this year. The bispecific linvoseltamab continues to show potential as a best-in-class treatment for late-line myeloma.

At the AACR Medical Meeting, the company presented positive results from a study of 117 patients, with a 71% objective response rate and 46% achieving a complete response or better. They plan to present updated results at the upcoming EHA meeting. The company believes the confirmatory study will support approval, and they are also evaluating the use of their drug in earlier stages of myeloma and precursor conditions. The company's costimulatory bispecific antibodies are being tested in various studies, including in combination with other drugs. They plan to present updated results at ASCO, including promising activity in microsatellite stable colorectal cancer. The company has not observed severe adverse events with their treatment. They are also enrolling patients in various cancers for further testing. The company is also planning to initiate combination treatment with their PSMAxCD28 costim bispecific and their PSMAxCD3 bispecific, which may have better tolerability.

The company is evaluating several bispecific drugs for different types of cancer, including myeloma and lymphoma. They are also developing a first-in-class combination therapy for paroxysmal nocturnal hemoglobinuria and are planning to extend this approach to other diseases such as geographic atrophy and venous thromboembolism. They are also working on a first-in-class antibody for iron overload diseases and will present updated data at an upcoming conference. A Phase 2 study for this antibody will begin in the second half of the year.

The company is developing an approach to address potential negative consequences of GLP/GIP receptor agonists, which can cause weight loss and muscle loss in obese patients. Their antibodies targeting myostatin related pathways have shown promising results in obese non-human primates, with a study in healthy volunteers ongoing. They also have a genetic medicines effort that has shown positive results in treating genetic hearing loss.

The company has seen success in their gene therapy and CRISPR technology programs, with plans to potentially bring more therapies to the clinic in the future. They have also achieved clearance for their insertion program for Factor 9 and have begun enrolling patients. In addition, they have had success with their sRNA collaboration and are preparing for a potential pivotal study for ALS treatment. The company's commercial portfolio is performing well and they are preparing for potential launches. Their anti-VEGF franchise, specifically EYLEA HD, has seen significant growth in sales.

The article discusses the success of EYLEA HD in extending the time between treatments and its high satisfaction among retina specialists. The drug has secured 45% of the anti-VEGF category share and has seen an increase in both switched and treatment-naive patients. The permanent J-code has improved reimbursement and market access, leading to increased use among existing and new customers. However, the changing payer market and utilization management have affected all branded products. The company is also focused on educating patients about the benefits of EYLEA HD and has launched a direct-to-consumer TV campaign. This has led to an increase in patients asking about and being prescribed EYLEA HD.

The launch of EYLEA HD has exceeded expectations and is on track to become the standard of care for retinal disease. Dupixent has also seen strong growth in global net sales, with over 850,000 patients currently on therapy and three indications achieving blockbuster status. The drug is competitively differentiated and has potential for further expansion into other Type 2 diseases, including COPD. If approved, Dupixent will be the first biologic medicine for COPD and the first new treatment in over a decade for this disease.

The paragraph discusses the potential approval of Dupixent for COPD and its expected impact on the company's growth. It also mentions the potential launch of itepekimab for COPD and the continued success of Libtayo in skin and lung cancers. The company's commercial team is focused on expanding its portfolio and increasing market share. The financial results for the first quarter are also mentioned.

In the first quarter, the company's total revenues increased by 7%, driven by sales growth and margin expansion from Dupixent and strong global sales of Libtayo. Collaboration revenue also increased, with a 14% growth in Sanofi collaboration revenue and a 26% increase in collaboration profit. The company expects the Sanofi development balance to be fully reimbursed by the end of 2026, resulting in a significant increase in collaboration profits. Despite lower volumes, U.S. Praluent sales were affected by a gross to net adjustment, but the company expects them to be modestly higher in 2024. R&D expenses also increased, reflecting continued investment in the company's pipeline.

In the first quarter, Regeneron's SG&A grew by 13%, driven by investments in the launch of EYLEA HD and international expansion. Gross margin on net product sales was impacted by start-up costs for a manufacturing facility. COCM declined by 22% due to lower Dupixent drug substance manufacturing costs. Regeneron generated $1.4 billion in free cash flow and announced a new $3 billion share repurchase program. Minor changes were made to full year 2024 financial guidance, with R&D expenses now expected to be in the range of $4.4 billion to $4.6 billion. Overall, Regeneron is positioned to continue delivering strong results in 2024 and beyond.

The speaker, George Yancopoulos, is answering a question from Colin Bristow about the company's muscle-sparing obesity program. Yancopoulos explains that their program is different from competitors because they have identified the specific members of a large family of factors that are involved in muscle preservation and have created antibodies to target them. They are testing these antibodies individually and together to determine their effectiveness and safety. The company believes their approach will lead to better quality weight loss and a favorable safety profile.

The speaker discusses the differences between their program and others in terms of blocking various members involved in bodily functions. They believe that the first regulatory endpoint will be increased weight loss, but they also recognize the potential for better quality of weight loss and its impact on metabolic parameters and functional endpoints. The simplest path for regulation may be through weight loss.

The speaker discusses the Phase 2 study and the importance of demonstrating the quality of weight loss in terms of fat versus muscle. They believe that preserving muscle and increasing fat loss could have widespread benefits for patients. The next question is about the EYLEA franchise and the impact of private equity firms acquiring retina practices. The speaker also mentions a reduction in wholesaler inventory of $40 million in the quarter.

The company has experienced a sequential drawdown of EYLEA inventory, but there has been a modest increase in EYLEA HD inventory ahead of the permanent J-code on April 1. The company is aware of the market segmentation and targets their approach to the marketplace accordingly. The range of customers in the retina market has evolved over time, but the company's commercialization approach has been effective in addressing this evolution. In regards to the COPD program, the data broadly supports the entire BLA and the approval of the drug in eosinophilic COPD. The FDA is thorough in their evaluation of new biologics and may consider labeling differently if there is a subpopulation driving the data, but this has not occurred in this case.

The company plans to submit results ahead of schedule for their severe food allergy study, which has shown consistent and meaningful reduction in COPD exacerbations across all subgroups. They hope to see early clinical proof of concept in the initial patients, with a focus on reducing the allergy-causing immunoglobulin IgE. If results are as dramatic as seen in pre-clinical studies, they may also conduct food challenge tests.

In the paragraph, George Yancopoulos explains that the animal studies suggest that patients treated with Dupixent may need to stay on the medication for a substantial period of time in order to prevent the production of IgE and promote the production of IgG. However, the medication is relatively safe and may be beneficial for patients with other atopic diseases, so it may be necessary for some patients to stay on it for a longer period of time.

The speaker discusses the potential long-term benefits of a new treatment for patients with Type 2 excess inflammation, as they are typically considered atopic patients. They also mention their excitement about their LAG-3 program and the potential for it to be more active than other programs, especially in melanoma. They are eagerly awaiting follow-up data from other studies to see if their hopes are confirmed.

The speaker, William Pickering, asks a question about the dose and safety profile of the food allergy program being tested by the company. George Yancopoulos responds by stating that they will be using lower doses compared to their myeloma program, as non-malignant cells are more susceptible to the treatment. They also expect the program to be well tolerated and have a shorter treatment duration. Leonard Schleifer adds that they have had a high success rate and low side effects with the myeloma program.

The speaker discusses whether taking a holiday from treatment would require starting over with the elimination of IgE cells, and explains that this is unlikely due to the slow process of reaching high levels of IgE. They also mention that Grade 3 events, which are related to cytokine release syndrome, may be less likely in patients with lower cancer cell loads. The speaker then moves on to a question about bispecifics and autoimmune disorders, specifically mentioning the potential for T cell engages in lupus and other conditions. They ask if Regeneron is working on leveraging their expertise in bispecifics for this purpose.

The speaker is discussing the recent acquisition of 2seventy and the collaboration between the two companies in pursuing CAR-T programs for autoimmune diseases like lupus. They are planning to conduct side by side studies to compare CAR-T approaches to bispecifics, with the belief that bispecifics may be just as effective and safer for treating normal cells in autoimmune diseases. The company has also initiated studies on bispecifics for decreasing autoantibodies in other autoimmune diseases and is now exploring this further with their internal Regeneron Cell Medicines group, which includes the expertise and leadership of 2seventy.

During a conference call, a question was asked about the potential impact of Dupixent's launch in the COPD market. The operator introduced the question from Brian Abrahams of RBC Capital Markets and the question was directed to Marion McCourt. McCourt responded by saying that there is a lot of excitement among doctors for Dupixent in COPD, but since it is a new space for biologics, there may be a need for education. She also mentioned that the team is experienced in launching Dupixent and is working on applying best practices. McCourt believes that there is a great opportunity to help patients with eosinophilic COPD and they will be thoughtful in reaching physicians and aligning with reimbursement and affordability. The call moderator, Ryan Crowe, announced that there was time for two more questions. The next question came from Mohit Bansal of Wells Fargo and was about itepekimab.

The speaker discusses the potential for disease modification with AAV modeling and asks about markers to look for in the Phase 3 trial. George Yancopoulos responds that Dupixent may already be doing this in asthma and they will be looking at overall loss of lung function over time. The last question asks about the linvoseltamab launch and thoughts on moving into earlier lines in myeloma, which Marion responds to.

The speaker discusses the potential benefits of MRD negativity in treating myeloma and the company's plans to launch a new drug, linvoseltamab, for this purpose. The IR team at Regeneron is available to answer any remaining questions about the drug.

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