Regeneron Pharmaceuticals, Inc.

Welcome to the Regeneron Pharmaceuticals First Quarter 2025 Earnings Conference Call. My name is Josh, and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Please note that this conference call is being recorded. I will now turn the call over to Ryan Crow, Senior Vice President, Investor Relations. You may begin.

Thank you, Josh. 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 2025 earnings conference call. An archive and transcript of this call will be available on Regeneron's investor relations website shortly after the call ends. 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, 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, where the quarter ended March 31, 2025, 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 the reconciliation of those measures to GAAP is available in our quarterly results press release and our 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 joining today's call. For my remarks, I will review some of our key performance drivers, then briefly discuss some pipeline advances we've made this year. I will then hand the call over to George, who will provide additional insights on our pipelines. From there, Marion will review our first quarter 2025 commercial performance. And finally, Chris will detail our financial results and provide an update on our 2025 financial outlook. Let's get to it. Regeneron's performance in the first quarter was mixed with some difficult news related to our retinal franchise, offset by encouraging news relating to the rest of our commercial portfolio, as well as advances in our robust pipeline of differentiated clinical candidates, beginning with ILEA and ILEA-HD. On a macro basis, in the first quarter of 2025, the overall size of the branded anti-VEGF category contracted due to an increase in the usage of low-cost, off-label, repackaged Avastin, likely driven by patient affordability issues because of a funding gap at copay assistance foundations. With respect to ILEA, first quarter 2025 U.S. net sales were 736 million, down 39 percent compared to the first quarter of last year, and down 38 percent compared to the fourth quarter of 2024. However, physician unit demand decreased by 14 percent sequentially, with the balance of the decline primarily attributable to lower wholesale inventory levels which ended the quarter in the normal range. With respect to ILEA HD in the United States, first quarter 2025 sales were $307 million, up 54% compared to the first quarter of last year, and were essentially flat on a sequential basis. Compared to the fourth quarter of 2024, ILEA HD physician unit demand grew by 5%, which was offset primarily by a modest wholesaler inventory drawdown. On the regulatory front, last Wednesday, we were disappointed with the FDA's decision to issue a complete response letter for our submission seeking approval for the ILEA HD pre-filled syringe. Since receiving the CRL, we have held several teleconferences with the FDA to better understand the contents of the CRL, and believe the key outstanding issue relates to a question posed by the FDA to a third-party component supplier. This component supplier has expeditiously responded to FDA requests for information. The CRL did not identify any issues with respect to the safety or efficacy of ILEA-HD, the usability of the device, proposed labeling, or pre-approval inspection findings. We also recently announced that the FDA had accepted for priority review an SBLA for ILEA-HD to treat macular edema following retinal vein occlusion, or RVO, and for monthly dosing in approved indications following the use of a priority review voucher. We believe these product enhancements will strengthen ILEA-HD's position in the competitive anti-VEGF category if approved. Moving to Depixent. First quarter 2025 net product sales grew 20 percent globally on a constant currency basis versus the first quarter of 2024, reflecting strong growth across all approved indications in all groups, in all age groups, I should say, and in all geographic regions. In the U.S., where net product sales grew 19 percent, Depixent now leads in both new-to-brand prescription share and total prescription share across all of its approved indications, with the only exception being chronic spontaneous urticaria, or CSU, which was approved by the FDA only 11 days ago. The COPD launch in the U.S. continues to gain momentum, with prescribers increasingly appreciating the role of type 2 inflammation in certain patients with COPD, coupled with greater urgency to identify and treat eligible patients. Payers are increasingly recognizing the value that Dupixent offers and have implemented broad and favorable coverage decisions for commercial and Medicare patients. With those pieces in place, we now look to drive patient awareness of Dupixent as a new treatment option for COPD through a recently launched direct-to-consumer campaign. Libtio in the U.S. grew 21% compared to the first quarter of last year and has established itself as a cornerstone therapy for advanced non-melanoma skin cancer while its share of the lung cancer market continues to increase. In the highly competitive first-line advanced non-small cell lung cancer market, Libtio is now second in new-to-brand prescription share despite launching years after other competing therapies. reflecting its differentiated clinical profile and our commercial strategy. We expect Dupixent, ILEA-HD, and Libtyo to continue delivering significant growth for the foreseeable future through additional penetration in approved indications, potential future indications, potential combinations with other pipeline candidates, as well as other potential product enhancements. Now briefly moving to our pipeline, which now includes approximately 45 product candidates in clinical development. We continue to make significant investments in R&D, which have yielded notable progress across several key programs so far this year, including four regulatory approvals and nine regulatory submissions. For the remainder of 2025, we anticipate U.S. regulatory approvals flimboseltamab in relapsed refractory multiple myeloma, odrinexamab in late-line follicular lymphoma, limptio in adjuvant CSCC, dupixin in bullous pemphigoid, as well as differentiated enhancements to the ILEA HD-US label. We also now expect to read out pivotal or proof-of-concept data across programs in immunology, oncology, hematology, internal medicine, and rare diseases, programs that George will discuss in a minute. In closing, Regeneron remains in a very strong position scientifically, commercially, and financially, enabling us to invest heavily in R&D and deliver scientific breakthroughs, maximize growth opportunities from our inline brands, successfully launch new products and indications, and return capital directly to shareholders through dividends and share repurchases. We look forward to providing updates on these efforts as we move through the remainder of 2025. With that, I'll turn the call over to George.