Regeneron Pharmaceuticals, Inc.

Good morning, and welcome to the Regeneron Pharmaceuticals' third quarter 2024 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 call is being recorded. I will now turn the call over to Ryan Crowe, 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 third quarter 2024 earnings conference call. An archive and transcript of this call will be available on the Regeneron 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, Senior Vice President and Chief Financial Officer. After our prepared remarks, the remaining time will be available for your questions. 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 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 September 30, 2024, 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 accessed on the Regeneron Investor Relations website. Once our call concludes, Chris and the IR team will be available to answer any further questions you may have. With that, let me turn the call over to our President and Chief Executive Officer, Dr. Leonard Schleifer. Len.

Thank you, Ryan, and thanks to everyone for joining today's call. Regeneron had a strong quarter, highlighted by 11 percent revenue growth and 8 percent non-GAAP earnings growth, along with continued investments and advances across our broad pipeline. For my remarks today, I'd like to review some of our key performance drivers and then briefly discuss near-term pipeline opportunities. After my remarks, George will provide further updates on our pipeline. Marion will then review our commercial performance. And finally, Chris will detail our quarterly financial results. Third quarter 2024 total revenues grew 11 percent to $3.72 billion, primarily driven by higher Sanofi collaboration revenues, reflecting the continued strong performance of Dubixent continued growth for Libtyo, and growth for combined ILEA-HD and ILEA in the United States. Dupixent had another strong quarter with global revenues up 24% on a constant currency basis to $3.8 billion. With this latest quarterly result, global Dupixent revenues are annualizing at over $15 billion, with over 1 million patients currently on treatment around the world, of course, seven approved indications in patients as young as six months. In September, the FDA and Chinese regulators both approved Dupixent for patients with uncontrolled COPD and an eosinophilic phenotype. These approvals, along with the approval in Europe in June, enabled Dupixent to address several hundred thousand patients that are currently uncontrolled on maximal inhaled triple therapy. As Marion will discuss, early launch indicators have been positive, with strong physician interest and initial favorable U.S. payer coverage decisions. As the only approved biologic for COPD, we anticipate these ongoing launches will represent a meaningful driver for Depixen's continued growth in 2025 and beyond. Net product sales for ILEA HD and ILEA combined were $1.54 billion, up 3% compared to the prior year. ILEA HD generated $392 million in its fourth full quarter on the U.S. market. ILEA HD and ILEA maintained anti-VEGF category leadership with combined share of approximately 44% compared to 45% in the second quarter of 2024. As Marion will discuss, we have focused on increasing ILEA-HD share while preserving share for ILEA in an increasingly competitive category, including a near-term biosimilar flibrocept 2 milligram launch and the recent launch of a branded pre-filled syringe. The ILEA-HD clinical profile continues to look differentiated relative to ILEA and other anti-VEG products. As George will soon detail, results from the recently reported photon extension study in DME further underscore ILEA-HD's unprecedented durability while achieving vision gains and a safety profile typically seen with ILEA. Moving to our pipeline, we're excited about several upcoming readouts later this year and in 2025 to further inform programs that could support significant long-term growth opportunities. By year end, we expect to share interim phase two lung cancer data for the combination of Fianlumab, our LAG3 antibody, plus Libtyo, as well as proof of concept data for our factor 11 antibodies in thrombosis, both of which will inform our phase three plans. Looking ahead to 2025, we expect to read out the results of our pivotal Aerofy studies for idopecumab, our IL-33 antibody, in former smokers with COPD. We will also learn more about potential opportunity to improve the quality of weight loss in obese patients on semiglutide by blocking myostatin and or activin A. Pivotal data for the pheanilumab-liptio combination in first-line metastatic melanoma are also anticipated which could support regulatory filings in this setting. In addition, we expect to provide periodic updates on our novel treatment approach for reversing severe food allergies involving limboxeltamab, our BCMA-by-CG3 bispecific, and Dupixit. In closing, our pipeline continues to generate innovative and differentiated opportunities and now has approximately 40 programs in clinical development spanning many distinct therapeutic areas. We view our pipeline as the key to driving near, medium, and long-term shareholder value, and our antibody platform technologies and the general and genetic-centered database of over 2.5 million sequenced exomes linked to the de-identified health records is expected to provide an enduring competitive advantage that we will continue to invest in. With that, I'll now turn the call over to George.