Regeneron Pharmaceuticals, Inc.

Welcome to the Regeneron Pharmaceuticals Second 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 listening 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, 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 second 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 of Dr. George Yancopoulos, Board Co-Chair, Co-Founder, President, and Chief Scientific Officer, Marian 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 10Q for the quarter ended June 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 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, please go ahead. Thanks, Ryan.

Thanks for you and everybody else who's joining today's call. For my remarks today, I will review some of our key performance drivers from the second quarter, then briefly discuss some pipeline advances we have made this year, and close with some comments on our capital allocation principles. I will then hand the call over to George, who will provide more details on our pipeline progress, while also highlighting some exciting emerging data from leading cohorts for our pivotal programs in myeloma and lymphoma. From there, Marion will review our commercial performance. And finally, Chris will detail our quarterly financial results and provide an update on our 2025 financial guidance. We turned on and delivered a strong second quarter, driven by durable growth drivers across our commercial portfolio. Worldwide net product sales for Dupixent increased by 21% and Liptio by 25% at constant exchange rates. while ILEA-HD in the U.S. grew by 29% compared to the second quarter of last year. With respect to ILEA, second quarter 2025 U.S. net product sales were 754 million, down 39% compared to the second quarter of last year. Sequentially, compared to the first quarter of 2025, physician unit demand declined by 10%, but net product sales were favorably impacted by prior period inventory dynamics. We expect ongoing switches to ILEA HD, competitive pressures, patient affordability issues, and pricing to continue to negatively impact ILEA US net product sales going forward. ILEA HD had a very encouraging performance in the second quarter with US net product sales reaching 393 million, an all-time high. driven by a notable step up in physician unit demand. Future product enhancements, including prefilled syringe administration and every four week dosing interval for approved indications and the addition of macular edema following retinal vein occlusion, or RVO, are expected to help further realize the ILEA-HD commercial opportunity. These ILEA-HD enhancements are now likely to be delayed from their August 2025 PDUFA dates as a result of observations from an FDA general site inspection at the filler for these regulatory applications, Catalan Indiana LLC, which was recently acquired by Novo Nordisk AS. Prior to its acquisition, this site was owned and operated by Catalan Inc., a leading contract manufacturer that in their fiscal year 2024 produced nearly $70 billion unit doses and did business with the vast majority of the top biopharmaceutical companies in the world. This inspection was completed in mid-July and was not specific to ILEA-HD. Novo has been in communication with the FDA and expects to file its comprehensive and robust response next week. Based on our review of the observation and Novo's proposed response, Along with the progress we have made with alternate third-party fillers, we anticipate an expeditious resolution of our filling issues for ILEA-HD. The DLA for ogenextamab, a bispecific antibody targeting CD20 and CD3 for relapsed refractory follicular lymphoma, was also impacted by the Catalan Indiana LLC site inspection and resulted in the FDA issuing a CRL earlier this week. Moving to Dupixent, second quarter 2025 global net product sales were $4.3 billion, up 21% on a constant currency basis versus the second quarter of 2024. Now annualizing at over $17 billion, Dupixent global growth continues across all approved indications in all approved age groups and across geographic regions. In the U.S., the PICS in net product sales grew 23% through the second quarter of last year and continues its leadership position in both new-to-brand prescription share and total prescription share across all indications approved prior to this year. Over the past 10 months, three new indications, chronic obstructive pulmonary disease, or COPD, chronic spontaneous urticaria, or CSU, and bullets pemphigoid, or BP, were approved by the FDA, enabling Dupixin to potentially treat more than 600,000 additional biologic-eligible patients. These approvals bring the total addressable population for Dupixin in the U.S. to over 4 million patients, of which only a small fraction are being actively treated. Positioning Dupixin to remain a strong growth driver over the near, medium, and long term. Global Liptio net product sales grew 25% on a constant currency basis compared to the second quarter of last year and are now annualizing at $1.5 billion. In the U.S., where net product sales grew 16%, Liptio continues to be the market-leading immunotherapy for advanced non-melanoma skin cancers while building share in the lung cancer market. We are looking forward to the FDA decision and potential launch later this year of Liptio in high-risk adjuvant cutaneous squamous cell carcinoma, where Liptio has the potential to become the standard of care. If approved, Liptio will be the first and only PD-1 antibody for this setting and would represent a significant advance for the up to 10,000 addressable patients in the US who could benefit from this treatment. Moving to our pipeline, which now includes approximately 45 product candidates in various stages of clinical development. We continue to make significant investments in R&D that have yielded notable progress across several key programs so far this year, which George will discuss in just a moment. Over the next six months, we anticipate phase three data for our C5 program in generalized myasthenia gravis, for Frianulamab, our LAG-3 antibody in combination with Liptio in advanced melanoma, for Garitosumab, our activin A antibody in fibrodysplasia ossificans progressiva, or FOP, and our programs for birch and cat allergies. We also expect to make a decision on next steps for idopecumab and COPD. Several differentiated early clinical and preclinical programs spanning hematology, genetic medicines, ophthalmology, oncology, and immunology represent an exciting next wave of innovations at Regeneron. Finally, I'd like to provide an update on how we think about allocating shareholder capital. At our core, we firmly believe that internal investment offers the greatest potential return for shareholders. Therefore, we plan to continue investing heavily in our internal R&D programs while also making significant capital investments in the United States to support anticipated future growth. We are investing over $7 billion in the U.S. over the coming years to expand our research and development capabilities and our manufacturing network, including a brand-new, state-of-the-art fill-finish manufacturing facility in Rensselaer, New York. We also believe that these critical investments should be complemented by direct returns of capital to shareholders through share repurchases and dividends, and we remain committed to funding both for the foreseeable future. Given the strength of our balance sheet, we also have the flexibility to engage in business development, and our focus remains on opportunities that can accelerate or strengthen our existing R&D capabilities. We have historically focused mainly on early stage assets and innovative platform technologies with significant synergies to our internal R&D efforts while also considering differentiated later stage opportunities in areas with high unmet medical need that complement our R&D focus. In closing, Regeneron's business remains sound with impressive commercial execution driving strong financial results in the second 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.