The paragraph introduces the Regeneron Pharmaceuticals' First Quarter 2025 Earnings Conference Call, led by operator Josh. Ryan Crowe, Senior Vice President of Investor Relations, welcomes participants and introduces key executives: Dr. Leonard Schleifer, Dr. George Yancopoulos, Marion McCourt, and Chris Fenimore. The call includes prepared remarks and a Q&A session. Attendees are reminded that forward-looking statements about Regeneron's business and financials may be discussed, which are subject to risks and uncertainties. An archive and transcript will be available on the company's Investor Relations website.

The paragraph discusses Regeneron's recent activities and future focus. It mentions material risks detailed in Regeneron's latest SEC filings and highlights that the company will discuss GAAP and non-GAAP financial measures during their call, with related information available online. Dr. Leonard Schleifer, Regeneron's President and CEO, will review the company's key performance drivers and pipeline advances. Following him, George will provide additional pipeline insights, Marion will discuss their first-quarter 2025 commercial performance, and Chris will update on financial results and outlook. The paragraph ends with Schleifer noting the mixed performance in the first quarter, with challenges in their retinal franchise but positive developments in their other commercial areas and clinical pipeline, specifically mentioning EYLEA and EYLEA HD.

In the first quarter of 2025, the branded anti-VEGF category, including EYLEA, saw a decline in sales due to increased use of off-label repackaged Avastin driven by affordability issues. EYLEA's U.S. net sales decreased significantly, while EYLEA HD sales increased 54% year-over-year but remained flat sequentially. A complete response letter from the FDA delayed approval of EYLEA HD's pre-filled syringe, with the outstanding issue related to a third-party component supplier. Despite this, the FDA accepted an sBLA for EYLEA HD for priority review to treat macular edema following retinal vein occlusion and for monthly dosing in approved indications.

The paragraph discusses the growth and strategic positioning of several pharmaceutical products. EYLEA HD's market position in the anti-VEGF category could improve with anticipated product enhancements. Dupixent saw a 20% increase in global net product sales in Q1 2025 compared to Q1 2024, now leading in prescription shares in the U.S., except for chronic spontaneous urticaria. Its COPD launch is gaining traction, supported by payer coverage and a direct-to-consumer campaign. Libtayo's sales in the U.S. grew by 21%, solidifying its role in treating advanced non-melanoma skin cancer and increasing its share in the lung cancer market, despite being relatively new compared to competitors.

The paragraph discusses Regeneron's growth expectations for products like Dupixent, EYLEA HD, and Libtayo, driven by increased usage in current and potential new indications, combinations, and enhancements. It highlights the company's robust pipeline with 45 clinical candidates and significant R&D investments, evidenced by regulatory successes. Anticipated U.S. approvals for key treatments in 2025 include linvoseltamab, odronextamab, Libtayo, and Dupixent, along with updates to the EYLEA HD label. The focus is on pivotal data releases in various therapeutic areas. Regeneron is positioned strongly in science, commerce, and finance, prioritizing R&D investment, product launches, and shareholder returns. George Yancopoulos is set to detail further pipeline opportunities.

The paragraph discusses recent developments related to Dupixent and other treatments. Dupixent has been approved for chronic spontaneous urticaria, marking its seventh FDA approval for a Type 2 allergic disease, and is the first new treatment for CSU patients in over a decade. It's also under priority review for bullous pemphigoid and has been approved for COPD in Japan. The company anticipates pivotal data for itepekimab, an interleukin-33 antibody for COPD, by 2025, and has initiated trials for chronic rhinosinusitis with and without nasal polyps. In oncology, regulatory filings for Libtayo in adjuvant cutaneous squamous cell carcinoma (CSCC) have been submitted in the U.S. and EU. Libtayo has shown significant benefits, reducing disease recurrence or death risk by 68%, and these findings will be presented at the ASCO Annual Meeting.

The paragraph highlights ongoing developments in cancer treatments, focusing on Libtayo's combination with fianlimab in solid tumors, particularly melanoma and non-small cell lung cancer. It mentions promising early clinical data in melanoma and anticipates results from a Phase 3 trial later in the year. In lung cancer, Phase 2 studies continue due to limited follow-up data, with further analysis expected in 2026. No new safety issues were reported. The European Commission has conditionally approved Lynozyfic (linvoseltamab) for relapsed/refractory multiple myeloma, with a similar submission accepted by the FDA, bolstering confidence in Lynozyfic's potential as a leading BCMAxCD3 bispecific therapy.

The paragraph outlines the progress in Regeneron's clinical programs. The company is focusing on monotherapy and limited drug combinations, with significant advancements in its Phase 3 LINKER-MM3 study for relapsed/refractory multiple myeloma, which is now fully enrolled. Initial results from the Phase 1/2 LINKER-MM2 trial show promising responses with linvoseltamab combinations. For odronextamab, targeting relapsed/refractory follicular lymphoma, the FDA has accepted a BLA resubmission with a PDUFA date set. In hematology, Regeneron is advancing its Factor XI program, working on tailored anticoagulation strategies, and planning pivotal study enrollments. Additionally, the company leverages its expertise in muscle biology and genetics to enter the obesity market, focusing on agents that improve GLP-1 weight loss while preserving muscle mass.

The paragraph discusses Regeneron's ongoing research and clinical trials. It highlights the Phase 2 COURAGE study investigating the combination of trevogrumab, a GDF8 antibody, with semaglutide, both with and without garetosmab, to improve the quality of weight loss. Results for the 26-week primary endpoints are expected later this year. The paragraph also mentions an upcoming presentation at the American Diabetes Association meeting about a related semaglutide program. Additionally, Regeneron reports progress in its genetic medicines pipeline, notable for its novel C5 siRNA and antibody combination showing promising results in treating paroxysmal nocturnal hemoglobinuria and potential improvements for generalized myasthenia gravis. The company is optimistic about its unique mechanism offering more complete C5 inhibition and more convenient treatments. Regeneron is committed to scientific innovation with a strong pipeline and anticipates multiple significant data reports later this year.

Despite a challenging first quarter, the company remains optimistic about future opportunities with product enhancements and new launches. However, U.S. net sales for EYLEA and EYLEA HD dropped to $1.04 billion, a 30% sequential decline due to reduced wholesaler inventory levels and competitive pressures. Physician demand for both products fell by 11%, partially because of funding gaps in patient assistance programs. As a result, low-cost off-label repackaged Avastin gained market share. Nevertheless, EYLEA HD and EYLEA retained market leadership with a 41% share in the anti-VEGF category. EYLEA's U.S. net sales reached $736 million, impacted by similar challenges, but the company continues to promote EYLEA HD, which achieved $307 million in sales, growing 54% year-over-year.

In August, potential FDA approvals for EYLEA HD's treatment of retinal vein occlusion and its extended eight-week dosing schedule could make it the first in its category to offer such flexibility. Anticipated label enhancements and a prefilled syringe option are expected to boost EYLEA HD demand. Meanwhile, Dupixent showed strong performance in the first quarter with global net sales of $3.7 billion, a 20% annual increase, despite some pricing impacts in the U.S. Dupixent leads the market across its multiple approved indications due to its unique mechanism addressing underlying disease drivers. It captures the majority of new patients in atopic dermatitis, leads in asthma prescriptions, and is experiencing growth in COPD treatment, benefiting from pulmonologists' existing familiarity with the drug.

Dupixent has demonstrated significant success in treating various conditions by reducing exacerbations, improving lung function, and lowering the need for oxygen therapy. Its launch for COPD has been highly successful, second only to atopic dermatitis. Recently approved for chronic spontaneous urticaria (CSU), Dupixent is the first new targeted treatment in over a decade, offering a solution for over 300,000 U.S. patients inadequately managed by antihistamines. The company is also seeking approval for Dupixent in treating bullous pemphigoid, a challenging condition with current treatments having efficacy and safety issues, especially for older adults. Dupixent stands as a standard treatment for several Type 2 inflammatory conditions, with potential for further expansion. Additionally, Libtayo's global net sales for the first quarter increased by 8% year-over-year, reaching $285 million, with U.S. sales up by 21%, influenced by seasonal dynamics and shipment timing.

The paragraph discusses the increasing demand for treatments in the U.S. for non-melanoma skin cancer and lung cancer, as well as international growth in approved indications. The company anticipates potential FDA approval for Libtayo for high-risk cutaneous squamous cell carcinoma, which could benefit around 10,000 U.S. patients. They are also preparing to launch two new hematology products, linvoseltamab and odronextamab, which have shown strong clinical results. Financially, Regeneron reported first-quarter 2025 revenues of $3 billion, largely due to growth from Dupixent and EYLEA HD sales. Their collaboration revenue with Sanofi was $1.2 billion, with a significant portion from profit-sharing, and their partnership with Bayer involved EYLEA sales outside the U.S.

In the first quarter of 2025, Regeneron reported revenues of $858 million, a 5% increase from the previous year, and included $146 million from EYLEA 8 mg sales. Bayer collaboration revenue was $344 million. Operating expenses highlighted a $1.2 billion R&D expense due to investments in Regeneron's pipeline, while SG&A decreased by 8% to $537 million due to lower administrative expenses. The gross margin on net product sales was 85%, affected by higher inventory write-offs and a changing product mix. The effective tax rate increased due to reduced stock-based compensation benefits. Regeneron generated $816 million in free cash flow and held $17.6 billion in cash and securities, with $2.7 billion in debt. The company also announced a $3 billion investment with FUJIFILM Diosynth Biotechnologies to expand its U.S. manufacturing capacity, while monitoring potential sector-specific tariffs.

Regeneron is planning over $7 billion in U.S. investments, including expansions in New York facilities and an additional property acquisition, to boost R&D and manufacturing capabilities. In the first quarter, they returned capital to shareholders through $1.1 billion in share repurchases, with $3.9 billion still available, and initiated a quarterly dividend program with a $0.88 per share payout in June. Their 2025 gross margin guidance has been updated to 86-87% due to higher inventory write-offs. These financial strategies are aimed at maintaining strong R&D efforts and delivering shareholder value.

The paragraph involves a discussion between Leonard Schleifer and Tyler Van Buren regarding the Complete Response Letter (CRL) from the FDA concerning the pre-filled syringe for EYLEA HD. Tyler asks for clarification on the FDA's questions and the comparison to the previous quick resolution of the EYLEA HD CRL. Schleifer explains that the FDA reviews new device submissions by examining the components, which may involve third-party suppliers. The FDA communicates directly with these suppliers through a drug master file, and the company seeking approval is not involved in that communication process.

The paragraph discusses a situation where Regeneron is dealing with questions from the FDA related to a supplier's Drug Master Files (DMFs). These questions were only received around the time of a Complete Response Letter (CRL). A key issue involves one supplier, which has already provided the necessary data to the FDA. Regeneron cannot access this data due to regulations, but the supplier believes it satisfies the FDA's requirements. The FDA has committed to reviewing this data quickly but hasn't guaranteed approval. The timeline for resolution is uncertain, as similar situations have taken months, although no reinspection is anticipated. The aim is to transition to a more efficient administration method using pre-filled syringes for intravitreal injections.

The paragraph is part of a discussion between company representatives and a research analyst, Alexandria Hammond, about the company's pipeline for a Factor XI antibody. George Yancopoulos and Leonard Schleifer respond to a question about prioritizing indications and timing of launches. They explain that they are working on a mix of expected indications, which may take longer, and some undisclosed ones they hope to push through more quickly. The focus is on demonstrating the benefit of their antibodies in terms of anticoagulation and bleeding risk profiles compared to current options. However, specific indications and timelines have not been disclosed.

The paragraph discusses the challenges faced by patients, particularly those over 65 on Medicare, in affording copays for anticoagulation therapy and treatments like EYLEA. It explains that while under commercial insurance, younger patients can access copay assistance directly from sponsors like Regeneron. However, once on Medicare, patients usually face a 20% copay unless they have supplemental insurance. Many do not have supplemental insurance and thus struggle with the costs of treatments such as anti-VEGF injections. The conversation also touches on the anticipated reopening of a foundation to address these affordability issues and the potential impact of this on treatment volumes shifting from generic alternatives back to branded agents.

The government has allowed companies to support patients needing financial assistance for retinal disease through independent charitable foundations. These foundations help eligible patients on a first-come, first-served basis, without direct ties to specific drugs like Vabysmo, Pavblu, or EYLEA. Regeneron has been a major funder of these foundations, contributing over $400 million last year. As their resources have changed, they aim to continue helping patients by encouraging others to contribute as well. One idea is a matching program, where Regeneron would match donations from others to ensure drug copay support is available to those in need, regardless of the drug chosen.

The paragraph is an excerpt from a discussion involving questions about philanthropy and regulatory approval for a prefilled syringe. The speaker expresses hope that increased philanthropy will benefit patients and discusses the approval process of a prefilled syringe component. Terence Flynn from Morgan Stanley asks if the component in question is the same as the one already approved in Europe. Leonard Schleifer confirms that it is the same design and components used in Europe, where it has been safely used for months. Although they do not anticipate issues with approval, the FDA still has questions that need addressing, highlighting that European approval doesn't guarantee automatic approval in the U.S.

In the paragraph, Akash Tewari from Jefferies asks about the percentage of U.S. patients receiving funding from Good Days for EYLEA in 2024, and whether other companies like Roche would participate in a matching program. Leonard Schleifer from Regeneron responds that they cannot correlate their contributions with EYLEA usage due to regulations and emphasizes their intention to encourage a community of donors without targeting specific entities. The discussion then shifts to the next question from Carter Gould with Cantor, who asks about regulatory operations and the pre-filled syringe.

The paragraph discusses the challenges faced by Leonard Schleifer's company regarding their fourth Complete Response Letter (CRL) from the FDA and delays experienced over the past year. Schleifer takes personal responsibility for these issues, emphasizing that the regulatory and manufacturing teams have performed well. He attributes the CRLs primarily to increased FDA scrutiny on third-party contract manufacturers post-COVID. According to Schleifer, the FDA is attempting to improve standards in these suppliers, which has led to more regulatory interactions for their active company. He acknowledges the dissatisfaction with the situation and mentions that changes in regulatory requirements have contributed to some issues, such as not enrolling enough participants in trials.

The paragraph discusses a conference call where industry professionals address questions about FDA approval delays related to manufacturing issues and strategic decisions affecting drug development. Specifically, a question is posed about the therapeutic target IL-33 for the drug itepekimab following its Phase 2 COPD data. George Yancopoulos explains that insights into IL-33 stem from genetic analyses indicating that variations in the pathway can influence susceptibility to COPD. Patients genetically deficient in this pathway tend to be protected, while those with higher IL-33 activity are more prone to COPD and other diseases. The development strategy for itepekimab is informed by these genetic insights, with expansion guided by results showing benefit in former smokers.

The paragraph discusses a clinical trial and potential future directions for a medical treatment. George Yancopoulos expresses optimism about the ongoing Phase 3 studies, which have shown promising interim results. He also highlights strong genetics and Phase 2 data, and mentions upcoming studies in asthma and COPD. Ryan Crowe and William Pickering then inquire about the EYLEA HD monthly dosing submission. Leonard Schleifer confirms that the submission was accepted by the FDA, indicating no deficiencies, though he does not provide specific details on the enrollment percentage or alignment with the FDA. The conversation underscores confidence in the submission's sufficiency and ongoing review process.

In the paragraph, Evan Seigerman from BMO Capital Markets asks Leonard Schleifer about how he would redesign a system to provide patient assistance for Medicare without relying on charities and existing legislation. Schleifer suggests that the government could allow drug sponsors to provide direct copay assistance to patients, similar to what's done for commercial patients. He argues that this would ensure patients receive the best drugs prescribed by their doctors, rather than cheaper alternatives like Avastin, which is commonly given to poorer patients who can't afford copays. Schleifer believes direct copay assistance could improve patient access to necessary treatments.

The paragraph discusses a conference call where several topics are addressed. One speaker suggests a policy allowing direct copay assistance from sponsors to patients, which could benefit seniors by alleviating worries about treatment costs. Salveen Richter from Goldman Sachs asks about capital expenditure guidance, highlighting recent manufacturing developments and the economic environment. Chris Fenimore responds, noting a slight reduction in expenditure expectations due to timing but affirming commitment to capital plans. Lastly, David Risinger from Leerink Partners raises concerns about U.S. government actions perceived as harmful to biopharma innovation, including FDA disruption, undermining medical science and the NIH, tariff threats, and drug price reduction agendas from both the previous Trump administration and the current Biden administration.

Leonard Schleifer discusses the ongoing disruption in Washington and how it affects the biopharmaceutical industry. He highlights the importance of science in policymaking and offers assistance to leaders like RFK Jr. to ensure scientific principles guide decisions. Schleifer acknowledges room for improvement in the current system, citing issues encountered during COVID-19, but warns against abandoning scientific methodologies. He emphasizes the importance of retaining experienced individuals within the FDA and hopes the industry can influence policy positively during this transition period.

The paragraph discusses Regeneron's efforts to prioritize public health, featuring a statement by Ryan Crowe thanking participants for their interest in the company. He apologizes to those who didn't get to ask questions, assures that the Investor Relations team is available for further inquiries, and concludes the conference, after which the operator thanks participants and ends the call.

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