Regeneron Pharmaceuticals, Inc.

Welcome to the Regeneron Pharmaceuticals first quarter 2024 earnings conference call. My name is Josh 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 Crow, Senior Vice President, Investor Relations. You may begin.

Thanks, Josh. Good morning, good afternoon, and good evening to everyone listening around the world. Thank you for your interest in Regeneron and welcome to our first 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 for the quarter ended March 31, 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 the 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. With that, let me turn the call over to our President and Chief Executive Officer, Dr. Leonard Schleifer. Len?

Thanks, Ryan. Thanks to everyone joining today's call. We're generally off to a strong start in 2024, reflected in our solid first quarter financial results as well as the progress we have made across our pipeline in the first four months of the year. From my remarks today, I'd like to briefly review some of our key performance drivers and then discuss a few of our more differentiated development programs, which have the potential to drive sustainable long-term growth for the company and value for our shareholders. After my remarks, George will provide an update on our pipeline, Marion will then review our commercial performance, and Chris will discuss our financial results. First quarter, 2024 revenues grew 7% after excluding last year's revenue contribution from our COVID antibodies. Growth was primarily driven by Sanofi collaboration revenues and Liptio global net product sales, which grew by 14 percent and 45 percent, respectively. Two picks in global net product sales were 3.1 billion, up 24 percent, reflecting strong growth across all approved indications. ILEA-HD generated $200 million in its second full quarter on the U.S. market, outperforming recent launches in the anti-VEGF category. Now, with a permanent J-code in place, improving payer coverage, broad prescriber familiarity, and satisfaction with the ILEA-HD clinical profile, and direct-to-consumer TV promotion underway, we continue to position ILEA-HD as the new standard of care for retinal diseases. Shifting to chronic obstructive pulmonary disease, or COPD, where Regeneron and Sanofi have two differentiated opportunities to transform the treatment paradigm for patients living with this debilitating disease. As announced in February, our SBLA for Dupixent for the treatment of COPD with type 2 inflammation was accepted by the FDA for priority review with a June 27th PDUFA date. During its review of our submission, the FDA has requested additional efficacy analyses, including an information request received earlier this week regarding subpopulations from the Boreas and Notice Pivotal Studies. Our analyses across these requested patient subgroups indicate a consistent and clinically meaningful reduction in COPD exacerbations. While the FDA has requested these analyses be submitted by the end of May, we anticipate providing them substantially sooner. We and Sanofi are confident that these additional analyses strongly support the approval of dupixin and eosinophilic COPD. If the FDA determines that they need additional time to review these analyses, a decision on the SBLA could be delayed for up to three months. We and our partner, Sanofi, are preparing for a launch that many pulmonologists, respiratory key opinion leaders, and their patients are eagerly anticipating. If approved, dupixin would be the only biologic therapy for COPD and the first new treatment approach for this disease in more than a decade. There is a high unmet need in COPD with type 2 inflammation with approximately 300,000 eligible patients in the United States and another approximately 300,000 eligible patients in the EU and Japan where we are also seeking regulatory approvals. Turning to idopecumab, our IL-33 antibody, which is being evaluated in former smokers with COPD regardless of eosinophilic phenotype, we remain on track to report results and enable potential global regulatory filings in the second half of next year. Idapecimab can potentially address up to one million patients in the G7 countries, while China also represents a significant opportunity. We are very excited about potentially bringing these important new therapies to COPD patients while expanding our commercial respiratory franchise. In a moment, George will describe another key opportunity in our pipeline involving Dupixent in combination with our BCMA by CD3 bispecific antibody Limboceltamab, which we believe has the potential to address any severe allergy and allow the millions of severe allergy sufferers to stop living in fear of an accidental exposure. Moving from LinvoCeltumab in severe allergy to its differentiated opportunity in multiple myeloma, where it is currently under FDA and EMA review in the relapsed refractory setting. In our registration enabling data set, while cost trial comparisons, caveats apply, we believe LinvoCeltumab represents a best-in-class opportunity because it has the highest objective response rates and complete response rates at similar follow-up observed across the BMA bispecific class to date, requires the least number of days in the hospital compared to other drugs in the category, and is the only BCMA by CD3 agent currently under review or already approved by the FDA that evaluated every four-week dosing. If approved, We believe these are all important considerations for patients, caregivers, providers, and payers that could drive Linvoseltamib adoption. In closing, I'm excited and energized by the differentiated opportunities in our pipeline, which now has over 35 programs in clinical development spanning many distinct therapeutic areas. Our commercial team continues to execute well and is building momentum in competitive categories, and we continue to deploy capital with the goal of driving shareholder returns over time. With that, I'll turn the call over to George. Thanks, Len.