Regeneron Pharmaceuticals, Inc.

Welcome to the Regeneron Pharmaceuticals second quarter 2026 earnings conference call. My name is Michelle, and I'll 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 just turn the call over to Ryan Crowe, Senior Vice President, Investor Relations. You may begin.

Thank you, Michelle. 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 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, co-founder, board, co-chair, president, and chief executive officer, Dr. George Yancopoulos, co-founder, board, co-chair, president, and chief scientific officer, Marion McCourt, Executive Vice President Commercial, and Chris Fenimore, Executive Vice President Finance and Chief Financial Officer. For our call today, Len will briefly review key second quarter performance drivers, highlight important upcoming pipeline catalysts, and provide a few comments on capital allocation. George will then detail our recent pipeline progress, followed by Marion, who will review our commercial portfolio, and finally Chris will discuss our financial results and outlook. 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 forecasts and 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 who were 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 June 30, 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 Investors 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, and thanks to everyone for joining today's call. Before we begin, I would like to acknowledge with deep sadness the passing earlier this week of financial industry luminary and longtime Regeneron director, Arthur R. Ryan. Art served on our board for more than two decades and was a trusted advisor whose judgment, integrity, and business insight helped guide the company through many important milestones. Prior to joining Regeneron's board, he built a distinguished career in financial services, including serving as chairman and CEO of Prudential Financial, and previously as president and COO of Chase Manhattan Bank. In addition, Art left an enduring legacy of civic engagement and philanthropy throughout Newark and Essex County, New Jersey. On behalf of everyone at RegenerArt, I want to express our gratitude for Art's many contributions and years of service. We join his family and all who knew him in celebrating his life and legacy. We will miss his wisdom and unparalleled support of Regeneron's mission. Turning now to our business, Regeneron delivered another strong quarter with total revenues up 17% and non-gap earnings per share up 11% compared to the second quarter of 2025, making our second consecutive quarter of double-digit growth on both the top and bottom line. Tupixent, ILEA HD, and Leptile all set new all-time highs for quarterly net sales and are carrying strong momentum into the second half of the year. Tupixent global net product sales, as reported by Sanofi, were $6 billion, up 38% compared to the second quarter of last year on a constant currency basis. Demand trends across all approved indications remained robust, and accounted for the majority of the year-over-year growth. We in Sanofi continue to see a long runway for Dupixent growth, driven by further penetration of existing indications, expansion into additional age groups and international growth opportunities. Beyond Dupixent, we are rapidly advancing a broad portfolio of next generation programs that we believe can build on the foundation we've established with Dupixent. George will discuss some of our recent progress in this area, including encouraging early clinical data from a long-acting interleukin-13 antibody. Our collaboration with Sanofi spans nearly two decades and has been one of the most successful in the biopharmaceutical industry. Together, we have built a highly productive development and commercialization engine and the continued success of Dupixin in nine FDA-approved indications across specialties ranging from dermatology, pulmonology, gastroenterology, ENT, and allergy, highlights the value that this model can create. Given that success, I can report that we have had productive early discussions with Sanofi to identify potential opportunities for further collaboration, including for several of Regeneron's Depixent follow-on programs. Aaliyah HD in the U.S. continued to gain momentum, with net product sales in the second quarter of nearly 600 million, up 52% compared to the prior year. Importantly, this quarter marked the first time Aaliyah HD net sales exceeded Aaliyah, highlighting the continued strength of the conversion to a next-generation product. Physician unit demand for Aaliyah HD in the second quarter increased 24% sequentially, reflecting continued strong uptake following recent FDA label expansions and growing prescriber appreciation for ILEA-HD's differentiated profile and dosing flexibility. We continue to work towards obtaining approval for yet another product enhancement for ILEA-HD, the ILEA-HD pre-filled syringe. We expect launch of this enhancement to drive even further adoption of ILEA-HD and we are continuing to work closely with the FDA and multiple contract manufacturers with a goal of approval before the end of the year. All in all, ILEA-HD has performed extremely well and we look forward to continuing to grow this product. Liptire maintained its strong growth trajectory in the second quarter. Global net product sales reached nearly 500 million, up 29% compared to last year on a constant currency basis. was driven by continued strong adoption in its approved non-melanoma skin cancer indications and further penetration in non-small cell lung cancer, where Leptire now captures 20% of new-to-brand prescriptions in the U.S. Beyond its growing patient impact and commercial contribution, Leptire remains the strategic backbone of our ongoing efforts to expand and strengthen our oncology portfolio. Turning to the rest of the pipeline, I firmly believe that one of Regeneron's core strengths is that we do not rely on any single program or platform. Our pipeline is broad, diversified, and highly productive. And while not every program will succeed, we are confident that it will create many substantial value for patients and shareholders. With approximately 50 active clinical programs and many rapidly advancing preclinical candidates, we have one of the largest R&D portfolios in the entire industry. George will have more details on our pipeline progress in his remarks, but I want to highlight a few important programs where we expect near-term regulatory and clinical milestones. We anticipate multiple milestones for our C5-complement programs, including an FDA decision in November for our new drug application for simdisoran and siRNA that targets C5 in generalized myasthenia gravis, which we believe has the potential to offer a differentiated profile for patients living with this serious autoimmune disease. We also continue to make meaningful progress across several longer-term value drivers, including Factor XI for coagulation disorders, limbiceltumab for multiple myeloma and premalignant conditions, and our obesity portfolio, where we expect multiple Phase III study initiations later this year. Now to a few comments on capital allocation, where our framework remains consistent. First and foremost, we believe the highest return opportunities to continue from investing in our own science. At the same time, we remain active in evaluating external opportunities. We're casting a wide net across the universe of business development options with particular interest in areas where we can leverage, regenerate differentiated expertise in genetics, antibody engineering, clinical development, manufacturing, and product commercialization. While we remain disciplined on valuation and strategic fit, we believe our financial strength, scientific capabilities, operational infrastructure, and long-term perspective position us well to capitalize on compelling opportunities as they emerge. In closing, our ability to repeatedly discover, develop, and deliver important medicines has been a defining strength of Regeneron for decades. This court is performing. together with the important milestones ahead reinforces our confidence in the company's long-term outlook. We have a thriving commercial business, a deep and diverse pipeline, and a talented team committed to improving patients' lives through science. Together, these strengths position us well to continue delivering meaningful innovation for patients and sustainable value for our shareholders.