Regeneron Pharmaceuticals, Inc.

Welcome to the Regeneron Pharmaceuticals fourth quarter 2021 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 is being recorded. I will now turn the call over to Mark Hudson, Director of Investor Relations. You may begin.

Thank you, Michelle. Good morning, good afternoon, and good evening to everyone listening around the globe. Thank you for your interest in Regeneron, and welcome to the fourth quarter 2021 conference call. An archive of this webcast will be available on our website. Joining me on the call today are Dr. Lynn Schleifer, founder, president, and chief executive officer, Dr. George Encopolis, co-founder, president, and chief scientific officer, Mary McCourt, executive vice president and head of commercial, and Bob Landry, executive vice president and chief financial officer. After a prepared remarks, we'll open up the call for Q&A. I'd 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-K for the period ended December 31, 2021, which you are planning to file with the SEC early next week. 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 measures will be discussed in today's call. Information regarding our use of non-GAAP financial measures and 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 Lange 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. Langeleifer.

Thanks, Mark, and thanks to everyone joining today's call. The fourth quarter of 2021 capped off a terrific year for Regeneron. Our performance was driven by strong execution across the organization, despite the ongoing challenges posed by COVID-19. We're all proud of the incredible work and dedication of our employees who continuously deliver on our mission to bring important medicines and novel medical breakthroughs to patients in need. Throughout 2021, we delivered strong top and bottom line growth. Revenues, excluding our COVID antibody cocktail, grew 19%, a testament of our diversified and strengthening core business. Our innovative and world-class pipeline advanced across a wide variety of diseases. We also unveiled initial clinical data and pipeline advancements from our Regeneron genetics medicines portfolio. which has the potential to unlock significant long-term value. Additionally, we return substantial cash to shareholders in the form of share buybacks. In 2021, we spent approximately $1.7 billion repurchasing over 3 million shares. For ILEA, 2021 global sales grew 19% to $9.4 billion. Even after 10 years on the market, and millions of injections later. We continue to view ILEA as an enduring product with significant future opportunity despite new market entries. In the second half of the year, we look forward to the results from our Phase 3 Aflibriset 8-milligram high-dose program. If those data continue to support that Aflibriset 8 milligrams provides extended dosing durations, Without compromising on safety and efficacy, Aflibicet 8mg has the potential to complement and enhance our retinal franchise. With Depixent, we're delivering on a goal of transforming the treatment of type 2 inflammatory diseases. 2021 global sales of Depixent were $6.2 billion, representing 53% growth for the year. Looking ahead, Depixent's outlook is bright. There are significant opportunities to increase market penetration rates in approved indications. And we are in the midst of a wave of new data submissions and launches in potential new indications further fueling Dupixent's growth. In oncology, Liptio continues to thrive in the approved non-melanoma skin cancers. We look forward to potential Liptio plus chemotherapy opportunities approval later this year in the broader population of non-small cell lung cancer patients. Our oncology footprint continues to expand. We have advanced many candidates and combinations into the clinic with a range of antibodies, bispecifics, and co-stimulatory bispecifics across many cancer settings. This year, we look forward to sharing what we hope will be groundbreaking data and difficult-to-treat solid tumors such as prostate cancers and ovarian cancers, both of which are conditions with historically low response rates to immunotherapy. We also remain encouraged in the progress of our maturing CD3 bispecifics. We are confident in the overall safety and efficacy profile for a dronextamab, our CD20 by CD3 bispecific. We are forging ahead with REGN5458, our BCMA by CD3-bispecific, which we believe will play an active role in the treatment of multiple myeloma given its competitive profile. Last but not least, we are immensely proud of our rapid response efforts against COVID-19. In 2021, with Gencov, our antibody cocktail was administered to millions of people globally, making a major impact during the darkest days of the pandemic. Based on preclinical data, we recently announced that Regencov is highly unlikely to be active against the Omicron variant. Appropriately, the FDA amended the emergency use authorization for Regencov, limiting its use in the U.S. in light of the Omicron variant being dominant. Regeneron remains committed to helping fight the COVID-19 pandemic, we are progressing next-generation antibodies that are active against Omicron Delta and other variants of concern. We are scaling up manufacturing efforts and completing the necessary requirements to begin clinical trials for next-generation candidate in the coming months. Concurrently, we are working closely and collaboratively with the FDA and other global regulatory authorities to establish and define clinical pathways to bring additional safe and effective monoclonal antibody treatment options to patients as quickly as possible. As one of the leaders in the fight against COVID-19, our Velocisweep platform of technologies makes us uniquely positioned to promptly develop and deliver potentially life-saving medicines. As the COVID-19 story transforms, from pandemic to endemic, we believe there will remain a significant opportunity to use our next generation monoclonals as a prevention for those immunocompromised individuals who do not respond adequately to COVID-19 vaccines. In addition, monoclonal antibody therapy is likely to play an ongoing role in treatment for infected individuals. In conclusion, 2021 was another high-performance year for Regeneron, with strong commercial results from our in-line marketed products, 30-plus pipeline candidates progressing through clinical trials, our discovery efforts firing on all cylinders, a growing portfolio of highly productive external collaborations, and our strong financial position with over $12 billion in cash and marketable securities and Regeneron is extremely well positioned for the future. Now I will turn the call over to George.