Regeneron Pharmaceuticals, Inc.

Welcome to the Regeneron Pharmaceuticals Second 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 second 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. We anticipate today's call will last approximately 60 minutes. 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 issues, 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 June 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 Investor Relations 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.

Glenn. Thanks, Ryan. Thanks to everyone joining today's call. Regeneron continued its track record of strong execution, highlighted by double-digit revenue and earnings growth in the second quarter, along with important advances across our broad pipeline. For my remarks today, I'd like to briefly review some of the key performance drivers for the quarter and then discuss near-term pipeline opportunities. After my remarks, George will provide further updates on our pipelines. Marion will then review our commercial performance, and finally, Chris will detail our quarterly financial results and discuss updates to our full-year guidance. Second quarter 2024 total revenues grew 12% to $3.55 billion, primarily driven by sales of ILEA HD in the United States, higher Sanofi collaboration revenues, reflecting the continued strong performance of Dupixent, as well as robust growth for Libtyo. ILEA HD generated $304 million in its third full quarter on the US market and continues to outperform recent launches in the anti-VEGF category. Net product sales for ILEA HD and ILEA combined were $1.53 billion, representing a 2.3% growth compared to the prior year. We are encouraged that despite increased competition in the anti-VEGF space, we have achieved a strong ILEA-HD launch trajectory while maintaining our category-leading combined ILEA-HD and ILEA market share of 45%. Our efforts to bring an ILEA-HD pre-filled syringe to the United States market remain a high priority, and we're tracking towards a potential pre-filled syringe launch by early 2025. In summary, we continue to position ILEA-HT as the new standard of care for retinal diseases based on its differentiated clinical profile coupled with strong familiarity and satisfaction among retinal specialists. Two picks in global revenues grew 29% on a constant currency basis to $3.56 billion, reflecting strong growth across all approved indications, age groups, and geographies. In June, the European Commission approved Dupixent for COPD in patients with raised blood eosinophils, marking the first global regulatory approval for Dupixent in COPD. This approval enables Dupixent to address the approximately 220,000 eosinophilic COPD patients in the EU that are currently uncontrolled on maximum inhaled triple therapy. The approval also represents the first biologic approved to treat this disease. We continue to work with the FDA regarding its ongoing review for this indication and expect their decision by the September 27th PDUFA date. We and our partner Sanofi are prepared for a U.S. launch that many pulmonologists, respiratory key opinion leaders, and their patients have been eagerly anticipating. There is a high unmet need in COPD with type 2 inflammation with approximately 300,000 eligible patients in the United States, and our potential launch represents a significant driver for Dupixent's continued growth. Leptio global net product sales were 297 million in the second quarter, an increase of 43% on a constant currency basis. Despite intense competition, Libtio has maintained its leadership position in non-melanoma skin cancers while making impressive inroads in non-small cell lung cancer. We are also pleased with the progress we have made in establishing an international commercial footprint to support Libtio and other future products following our purchase of full global rights to Libtio from Sanofi in mid-2022. Regarding limvaceltumab or BCMA by CD3 bispecific for relapsed refractory multiple myeloma, during its review of the limvaceltumab BLA, the FDA informed us that the third-party fill-finish manufacturer for limvaceltumab had unresolved findings from approval inspection for another company's product candidate. While we now believe these findings have been resolved, a re-inspection will be required, and therefore we anticipate any potential FDA approval for limvaceltumab is likely to be delayed beyond the August 22nd PDUPA date. The FDA has not informed us of any approvability issues for limvaceltumab related to safety, efficacy, or the status of our ongoing confirmatory trial. More broadly on our pipeline, we are excited about several upcoming readouts later this year or in 2025 to further inform programs that could support significant long-term growth opportunities, which George will discuss in a moment. In closing, our pipeline continues to generate innovative and differentiated opportunities and now has over 35 programs in clinical development spanning several distinct therapeutic areas. Our commercial team is executing well with our in-market products and is building momentum in competitive categories. Finally, We continue to prudently deploy capital with the goal of delivering long-term value to shareholders. With that, I'll turn the call over to George.