Regeneron Pharmaceuticals, Inc.

Welcome to the Regeneron Pharmaceuticals First Quarter 2021 Earnings Conference Call. My name is Mary, and I will be your operator for today's call. At this time, all participants are in the listen-only mode. Later, we will conduct a question-and-answer session. Please note that this conference is being recorded. I will now turn the call over to Justin Holcomb, Vice President, Investor Relations. You may begin.

Thank you, Mary. Good morning, good afternoon, and good evening to everyone listening around the globe. Thank you for your interest in Regeneron Pharmaceuticals, and welcome to the first quarter 2021 conference call. An archive of this webcast will be available on our website. Joining me on the call today are Dr. Leonard Schleifer, founder, president, and chief executive officer, Dr. George Yancopoulos, co-founder, president, and chief scientific officer, Marion McCord, executive vice president and head of commercial, and Bob Landry, Executive Vice President and Chief Financial Officer. After our prepared remarks, we will open the call for Q&A. I would also like to remind you that remarks made on today's call 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 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 period ended March 31, 2021 – which we filed with the SEC earlier today. 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 the GAAP and non-GAAP measures will be discussed in today's call. Information regarding our use of non-GAAP financial measures and a reconciliation of those measures to GAAP is available in our financial results press release, which can be accessed on our website. Once our call concludes, Bob Landry and the IR team will be available to answer further questions. With that, let me turn the call over to our President and Chief Executive Officer, Dr. Lenschleifer.

Thank you, Justin, and thank you to everyone joining today's call. We're off to a strong start in 2021, again delivering double-digit growth on the top and bottom lines. I'm immensely proud of all that Regeneron continues to accomplish in in the fight against COVID, and for patients suffering from a variety of diseases. Our performance highlights the continued evolution, diversification, and durability of our business as we enter a new phase of growth and new product launches. Strong performance begins with differentiated products that deliver real value for patients. Starting with ILEA, global net sales were nearly $2.2 billion, growing 17% compared to the prior year. In the U.S., sales grew 15%, reflecting continued positive momentum and execution on our strategy. We are confident in the ILEA business and expect it will remain a key growth driver for Regeneron for years to come. We are also very pleased with the performance of Dupixent in the quarter, where global sales approached $1.3 billion in and grew 48%. The brand is now annualizing sales in excess of $5 billion, yet we believe there remains considerable room for further market growth and penetration in atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis. With several additional potential indications in Phase III trials, such as eosinophilic esophagitis, and COPD, we are still in the early days of realizing the full potential of this unique pipeline in a product. In oncology, we are making steady progress with Libtyo as global net sales reached 101 million and grew 35% from the prior year. Importantly, in February, we secured two new FDA approvals for Libtyo in basal cell carcinoma, and in non-small cell lung cancer, which we anticipate will help fuel a new period of growth for this product that is a foundation to our oncology strategy. While still in very early days with these new launches, we are seeing encouraging signals on a variety of leading indicators from thought leaders, prescribers, payers, and patients. And last but not least, we were able to deliver significant phase three outcome data for our RegenCOVE program aimed at treating and preventing COVID-19 infections. As George will outline momentarily, we have now shown that our antibody cocktail dramatically reduces hospitalizations or death in non-hospitalized COVID-infected patients and reduces symptomatic infections when given as a preventative measure. We are seeking to update our emergency use authorization to reflect these new data and uses, as well as the lower 1.2 gram dose. Thinking longer term for RegenCov, we see an ongoing global need for treatment and chronic prevention of COVID disease. Despite high rates of vaccination, it's estimated that tens of millions will remain unvaccinated in the U.S. alone, And of those who are vaccinated, significant numbers will not mount a protective response, such as those who are immunocompromised or immunosuppressed. It is important to recognize Regeneron's and the biopharmaceutical industry at large response and ongoing actions in combating COVID-19. Breakthrough vaccines and treatments are having a profound impact on the health and well-being of people in the United States and around the globe. In addition, safe and effective vaccines and treatments are enabling economic recovery. All of these critical benefits come as a result of the investments that have been made in technologies over decades by both the public and private sectors. These profound effects highlight the importance of a healthy biopharmaceutical industry that fully incentivizes innovation, so that new solutions to emerging disease can rapidly be invented and deployed. We've also learned that these extraordinary approaches to preventing and treating COVID-19 can work only if people actually receive the vaccines or drugs. For example, an internal health economic analysis projected that tens of thousands of lives in the United States could be saved over the next several months if Regencov were fully deployed and given to all appropriate patients who are diagnosed with COVID-19 and at high risk for hospitalization or death. And this is a case where cost to patients is not an issue, as the government is providing the drug free of charge. Clearly, we have to better understand why a drug that has demonstrated overwhelming evidence for its ability to reduce hospitalizations or death by 70%, is an ample supply, has been endorsed by the NIH, has been authorized under an EUA by the FDA, and is free of charge to patients, is not being taken full advantage of. Regeneron is committed to collaborating with our healthcare partners to take optimal advantage of the Regencov cocktail potential health benefits. Overall, we are pleased in all that Regeneron has accomplished in the first three months of the year and look forward to continued momentum and progress across our diverse pipeline in the months to come. Now I will turn the call over to George.