Regeneron Pharmaceuticals, Inc.

Welcome to the Regeneron Pharmaceuticals first quarter 2026 earnings conference call. My name is Kevin and I'll be your operator for today's call. At this time, all participants are on a listen-only mode. Later, we will conduct a question and answer session. Please note this conference is being recorded. I will now turn the call over to Ryan Crow, Senior Vice President, Investor Relations. You may begin.

Thank you, Kevin. Good morning, good afternoon, and good evening to everyone listening around the world. Thank you for your interest in Regeneron and welcome to our first quarter 2026 earnings conference call. An archive and transcript of this call will be available on the Regeneron Investor Relations website shortly after our call concludes. Joining me on today's call are Dr. Leonard Schleifer, Board Co-Chair, Co-Founder, President, and Chief Executive Officer, Dr. George Yancopoulos, Board Co-Chair, Co-Founder, President, and Chief Scientific Officer, Marion McCourt, Executive Vice President of Commercial, and Chris Fenimore, Executive Vice President and Chief Financial Officer. After our prepared remarks, the remaining time will be available for Q&A. I would like to remind you that remarks made on today's call may include forward-looking statements about Regeneron. Such statements may include but are not limited to those related to Regeneron and its products and business, financial forecasting guidance, development programs and related anticipated milestones, collaborations, finances, regulatory matters, payer coverage and reimbursement, changes to drug pricing regulations and requirements, and our drug pricing strategy. intellectual property, pending litigation, and other proceedings, and competition. Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement. A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-Q for the quarter ended March 31, 2026, which was filed with the SEC this morning. Regeneron does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise. In addition, please note that GAAP and non-GAAP financial measures will be discussed on today's call. Information regarding our use of non-GAAP financial measures and a reconciliation of those measures to GAAP is available on our quarterly results press release and corporate presentation, both of which can be found on the Regeneron Investor Relations website. Once our call concludes, the IR team will be available to answer any further questions. With that, let me turn the call over to our President and Chief Executive Officer, Dr. Leonard Schleifer. Len.

Thanks, Ryan. Thanks to everyone for joining today's call. We were pleased with Regeneron's performance to start 2026, highlighted by strong commercial execution across our key growth products. continued pipeline progress, a disciplined approach to capital allocation, and our agreement with the U.S. government to lower drug prices for American patients while preserving innovation. Starting with the financials, we delivered double-digit growth across both revenues and earnings. Total revenues increased 19% compared to the first quarter of 2025, and non-GAAP earnings per share increased 15%. demonstrating our ability to deliver strong operating performance while continuing to invest in our science and long-term growth opportunities. Global Dupixent net sales increased 31% on a constant currency basis to $4.9 billion in the quarter. Growth was broad-based and driven by continued strong demand across multiple approved indications and geographies, reinforcing Dupixent's position as the foundation of our immunology franchise. We also continue to advance our efforts with next generation therapeutic approaches to strengthen our leadership position in inflammation and immunology. ILEA-HD US net product sales increased 52% year over year to 468 million. We continue to see encouraging physician adoption of ILEA-HD, reflecting confidence in its clinical profile and dosing flexibility. We resubmitted an application seeking FDA approval for filling of the ILEA-HD pre-filled syringe at Catalin, Indiana, where the FDA has recently conducted a site reinspection. In addition, the FDA did not act by the April 2026 PDUFA date for the company's regulatory application for a second contract manufacturer for the PFS. Therefore, this application remains pending. Regeneron and both third-party filling manufacturers are working closely with the FDA to resolve all outstanding issues, and we anticipate a regulatory decision on one or both applications during this quarter. In oncology, global entire net product sales grew 54% to $438 million, driven by continued uptake in advanced cutaneous squamous cell carcinoma and advanced non-small cell lung cancer, as well as early contributions from the adjuvant CSCC indication, which received FDA approval in the fourth quarter of 2025. Turning briefly to our pipeline before George provides more details in his remarks, we've continued to make meaningful progress across multiple therapeutic areas, so far in 2026. Last week, we received FDA approval of Otarmine for genetic hearing loss, marking an important milestone for patients with this ultra-rare condition, and we have committed to offering this product for free. While this may seem like an unconventional decision, we believe it's the right one for Regeneron, and it reflects the ethos that we live by, pushing the boundaries of science to benefit humanity. Moving to other advances in our pipeline, we presented positive Phase III data for semdisoran, our investigational siRNA that targets C5 in generalized myasthenia gravis, which demonstrated a differentiated efficacy, safety, and convenience profile relative to approved myasthenia gravis therapies. We submitted a new application utilizing a priority review voucher and anticipate an FDA decision in the fourth quarter. In metabolic disease, we and HANSO announced positive phase three data in China for olotorapatide, our in-licensed GLP-GIP receptor agonist, with full data expected to be presented by HANSO later this year. To PICSIN, achieve multiple regulatory milestones, expanding the eligible patient population to younger age groups and to new diseases. In addition, the FDA accepted our biologics license application for Garitosumab and granted priority review with a decision in August, representing another important step forward for our rare disease portfolio. Briefly, on capital allocation. We continue to take an approach that balances internal investment, which we believe offers the greatest long-term return for shareholders, with direct return of capital through share repurchases and dividends, as well as business development. In support of that approach, Our board authorized a new $3 billion share repurchase program, reflecting confidence in our business and financial position. We also recently entered into strategic collaborations with Thelix and Trinetics. Finally, last week, we entered into a most favorite nation pricing agreement with the United States government, achieving our shared goals of ensuring timely and affordable access to groundbreaking medical advancements for medical patients, maintaining the United States leadership in biotechnology, innovation, and manufacturing, and addressing the imbalance in the distribution of costs for medical innovation, which we have long argued has placed a disproportionate burden on American patients. In closing, the progress we've made so far in 2026 reflects the strength of our science and execution and sets a solid foundation for an exciting remainder of the year. With that, I'll turn the call over to George to discuss our R&D progress in more detail.