Regeneron Pharmaceuticals, Inc.

Welcome to the Regeneron Pharmaceuticals First Quarter 2020 Earnings Conference Call. My name is Crystal, 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 is being recorded. I would now like to turn the conference over to Justin Holcomb, Vice President of Investor Relations. You may begin.

Thank you, Crystal. Good morning, good afternoon, and good evening to everyone listening around the world. Thank you for your interest in Regeneron Pharmaceuticals and welcome to the first quarter 2020 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 McCourt, Senior 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 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 and including its Form 10-Q for the quarterly period ended March 31, 2020, which has been filed with the SEC today. Regeneron does not undertake any obligation to update publicly 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 a reconciliation of those measures to GAAP is available in our financial results press release, which can be accessed on our website. Additional information about those measures is also available on the investor and media section of 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. Len Schleifer. Len? Len?

Thank you, Justin. And thank you to everyone for joining the call. I hope all of you are staying safe and well during this difficult time. We're living in a new reality, the reality of COVID-19. I am incredibly proud of the leadership role Regeneron is taking in the fight against COVID-19. Clearly, this pandemic is unprecedented in our lifetime for our company, our country, and the world and the world economies. Regeneron has spent decades and billions of dollars developing proprietary technologies that have created medical breakthroughs such as Dupixent and our novel antibody cocktail for Ebola, which is now under FDA review. These same technologies are now well-purposed for finding a treatment against the SARS-CoV-2 virus. We are making rapid progress in scaling up supply of our novel antibody cocktail which we expect to be in clinical trials this June. We are optimistic about this approach, which George will describe in greater detail. Also, we are working swiftly with our collaborator, Sanofi, to find a definitive answer on whether there is a role for Kevzara in helping to alleviate the devastating inflammation that affects patients who are critically afflicted with this virus. We are grateful for the tremendous partnership across industries, governments, and agencies such as the FDA and BARDA as we unite in the common cause to eradicate this disease. Beyond our therapeutic efforts, we continue to respond to other urgent COVID-related needs. We recently produced and donated viral transport media to New York State for use in 500,000 test kits and have provided financial support to nonprofits at the heart of the pandemic response in New York and beyond. Furthermore, we are sensitive to the rapidly evolving marketplace and working with customers to ensure that patients are able to receive the treatments they need to preserve vision as well as to treat inflammatory conditions, cancer, and other ailments that persist despite the realities of social distancing. Turning to some brief commentary on the first quarter, where we delivered another strong performance. In the quarter, negative impacts from COVID-19 were minimal. Our core brands, ILEA, Dupixent, and Libtyo, drove significant top and bottom line growth based on demand while we invested in and advanced our innovative pipeline. In this quarter, ILEA global net product sales grew 6% to $1.85 billion, including US ILEA net sales growth of 9% to $1.17 billion. In the last two weeks of March and early April, overall demand and new patient starts were softer due to COVID-19. However, we are encouraged by the rebound in demand in the most recent weeks. Marion will give you more color on this. First quarter Dupixent sales more than doubled compared to last year, and are now annualizing at more than $3.4 billion on continued market penetration and new launches in multiple disease settings. While there are early signs of impacts on new patient starts, we expect continued resilience for Dupixent during this COVID-19 period, given the profound efficacy and safety profile. With an anticipated regulatory action in pediatric atopic dermatitis later this month, and other data readouts in 2020, and initiation of new Phase III trials assessing Dupixent and several other type II inflammatory diseases, this exceptional medicine continues to be positioned for long-term growth. Importantly, Dupixent is driving continued diversification of our earnings base and enhancing our strong current and long-term financial positions. We also announced recently that we have completed the restructuring of our agreement with Sanofi on , which will lead to immediate accretion and further strengthen our overall portfolio. 2020 has brought urgent new priorities. Even though we are experiencing impacts to trial enrollment and new study starts, we remain on track for several significant clinical milestones, particularly in oncology. Recently, we announced that our first-line clinical trial in lung cancer assessing libtio was stopped early on an interim analysis due to superior overall survival versus chemotherapy. We will look to submit these data to regulators as soon as possible. We also intend to submit data for libtio and basal cell carcinoma and expect new data from our biospecifics program later this year. Additionally, the long-awaited Phase III readout from Facinumab, our anti-nerve growth factor program for osteoarthritis pain, will occur in the coming months. Before handing the call over to George, I want to share the immense pride and gratitude we have for our people working hard at Regeneron during this time. Even in the current environment, our entire business is operating as our people drive important work forward that is essential to our mission, to patients, and to near and long-term value creation for shareholders. Our ability to do this rests on the talent and strength of our workforce, which in spite of COVID-related disruption, maintains incredible commitment, focus, and effort to advance the breadth of Regeneron's work. They are the foundations for moving forward our mission in normal times, and especially now. We are optimistic that Regeneron and our society will prevail through these unprecedented times, and we will work tirelessly to that end. Now, I'll turn the call over to George.