Regeneron Pharmaceuticals, Inc.

Welcome to the Regeneron Pharmaceuticals Third Quarter 2025 Earnings Conference Call. My name is Shannon, 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 is being recorded. I will now turn the call over to Ryan Crowe, Senior Vice President of Best Relations. You may begin.

Thank you, Shannon. Good morning, good afternoon, and good evening to everyone listening around the world. Thank you for your interest in Regeneron, and welcome to our third quarter 2025 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 McCord, 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 forecast and 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 of different material 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 September 30, 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 a 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 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. For my remarks today, I will summarize our third quarter top line performance, provide an update on ILEA HD regulatory matters, briefly discuss our recent pipeline progress, and close with some comments regarding our discussions with the United States government to lower drug costs for American patients while preserving innovation. I'll then hand the call over to George, who will provide more details on our pipeline progress. From there, Marion will review our commercial performance, and finally, Chris will detail our financial results and guidance. Regeneron delivered a solid third quarter, driven by double-digit net sales growth for three of our leading products. Compared to the third quarter of last year, worldwide net product sales for Dupixent increased by 26% and Libtayo by 24% at constant exchange rates, while ILEA-HD in the United States grew by 10%. Regeneron had Dupixent global net sales for the third quarter were $4.9 billion, as recorded by Sanofi, with strong growth continuing across approved indications in geographic regions. In the United States, Dupixen net product sales grew 28% compared to the third quarter of last year, while maintaining its leadership position in both new-to-brand prescription share and total prescription share across all indications approved prior to this year. Dupixen has now approved the United States to treat eight distinct diseases driven by underlying type 2 inflammation, including diseases of the skin, gut, and respiratory system, spanning age groups from infants to the elderly, and with more than 1.3 million patients globally being actively treated. Dupixent is one of the most widely used biologic medicines. Dupixent's approved indications could potentially address more than 4 million patients in the United States alone, positioning it to remain a strong growth driver over the near, medium, and long term. Global Libtyo net product sales were $365 million, up 24% on a constant currency basis compared to the third quarter of last year. In the U.S., net product sales grew 12%, where Libtyo continues to be the market-leading immunotherapy for advanced non-melanoma skin cancers while building share in lung cancer. Earlier this month, the FDA approved Libtyo in high-risk adjuvant cutaneous squamous cell carcinoma making Liptile the first and only PD-1 antibody indicated for this setting. While it only has been a few weeks since approval, a launch is already off to a great start, and we look forward to treating the up to 10,000 addressable patients in the United States who could benefit from this medicine. Moving to ILEA and ILEA-HD. Affordability issues continue to dampen branded anti-VEGF category growth. As announced in June, we initiated a matching program for up to $200 million in contributions to the Good Days Retinal Vascular and Neovascular Disease Fund. But I am disappointed to report that the match in the third quarter was under $1 million due to lack of donations from other potential contributors. We remain committed to matching future donations to this fund through the end of the year. Despite affordability headwinds, ILEA-HD had a strong performance in the third quarter, with U.S. net product sales reaching $431 million, an all-time high, driven by robust physician unit demand growth, partially offset by a lower net price. We continue to believe that future product enhancements, such as a four-week dosing interval, the inclusion of macular edema-filing retinal vein occlusion, or RVO, and a pre-filled syringe administration are needed to fully unlock ILEA's HD commercial potential. Earlier this month, we were notified by Catalan Indiana LLC, an affiliate of Novo Nordisk, that the FDA classified their facility as official action indicated, or OAI. And to date, the issues identified during the July 2025 inspection have not been completely resolved. On that basis, the FDA issued a complete response letter yesterday for the pre-filled syringe supplemental BLA with the sole approvability issue relating to unresolved inspection findings at Catalan. We continue to execute on our previously announced plan to submit an application to add an alternate pre-filled syringe filler by January 2026, which would trigger a four-month FDA review. We have also been diligently working with an alternate vial filler and have already submitted an application to include them in the ILEA HD BLA with a PDUFA date in late December. This would provide an additional opportunity for the FDA to approve the SBLA for every four-week dosing and RVO, given we believe there are no other outstanding review issues for this application. Moving briefly to our pipeline, which George will soon discuss in more detail, we continue to make significant investments in R&D that have yielded notable progress across several key programs. In just the past three months, we have announced positive phase three or registration enabling data for six distinct programs spanning immunology, neurology, allergy, and rare diseases. Over the next several months, we look forward to rapidly expanding pivotal programs in hematology, oncology, thrombosis, obesity, and other metabolic diseases, as well as allergies, all of which we believe represent an impressive next wave of innovative medicines discovered or developed by Regeneron. Finally, I'd like to take a moment to address our ongoing progress toward reaching an agreement with the US government to help lower the cost of medicines for American patients. We are having constructive discussions with the administration And I'm pleased to share that our priorities are closely aligned. Both Regeneron and the administration are deeply committed to ensuring that American patients have timely and affordable access to groundbreaking medical breakthroughs. We likewise share the goal of preserving the United States position as a global leader in biotech innovation and manufacturing. For more than a decade, George and I have argued that foreign governments have benefited from American innovation without sharing the burden of its cost. We are hopeful the efforts of this administration can level the playing field and convince high GDP nations to contribute their fair share rather than relying on the United States to shoulder the vast majority of this responsibility. By addressing this imbalance, we can ensure a more equitable global system that supports continued advancement in medicine while improving affordability for U.S. patients. Furthermore, we agree that investing in U.S. manufacturing is not only vital for creating jobs and strengthening our economy, but for safeguarding national security. In fact, in testimony before Congress in 2014, Regeneron highlighted the importance of prioritizing biotech manufacturing and innovation in the United States. Regeneron has already made significant commitments in this area including our plans to invest over $7 billion in infrastructure and manufacturing facilities in New York and North Carolina over the coming years. We remain optimistic about finding common ground with the administration that strikes the right balance between achieving our shared priorities while advancing Regeneron's mission of harnessing the power of science to deliver life-changing medicine to patients. In closing, Regeneron's business continues to perform well with impressive commercial execution driving strong financial results in the third quarter. Our pipeline is poised to deliver scientific breakthroughs that can potentially help treat millions of patients and translate into meaningful commercial opportunities. The commercial team remains focused on maximizing growth drivers from our inline brands while successfully launching new products and indications. Finally, we continue to prudently deploy capital with the goal of delivering long-term value to shareholders. With that, I'll now turn the call over to George.