Regeneron Pharmaceuticals, Inc.

Welcome to the Regeneron Pharmaceuticals' fourth quarter 2020 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 Justin Holko, Vice President, Investor Relations. You may begin.

Thank you, Michelle. Good morning, good afternoon, and good evening to everyone listening to the call today. Thank you for your interest in Regeneron Pharmaceuticals, and welcome to the fourth quarter 2020 conference call. An archive of this webcast will be available on our website. Joining me today on the call are Dr. Leonard Schleifer, founder, president, and chief executive officer, Dr. George Yancopoulos, co-founder, president, and chief scientific officer, Marion McCourt, executive vice president and head of commercial, Bob Landry, executive vice president and chief financial officer. After our prepared remarks, we will open the call for Q&A. I would 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, 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 year ended December 31, 2020, which we are planning to file with the SEC on Monday. 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 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 financial results press release, which can be accessed on our website. Once our call concludes, Bob Landry and the investor relations 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.

Thank you, Justin, and thanks to everyone joining on today's call. 2020 was a devastating year for so many individuals and their families who succumbed to COVID-19. At Regeneron, we have done all we can to be part of the solution, and we'll spend quite a bit of time today trying to inform you of our efforts. On a more general note for the company, despite operating in unprecedented circumstances of a global pandemic, Regeneron delivered strong commercial and financial results while advancing our innovative R&D pipeline and joining the fight against COVID-19. Despite COVID-19, we never lost sight of our focus on the patients who count on us for our innovative medicines and novel medical breakthroughs. For the full year 2020, we grew the top line by 30% and the bottom line by 28%, with an increasingly diversified set of revenue and earning streams. In fact, more than 80% of our top line growth came from products and revenues other than ILEA. ILEA global net sales were nearly $8 billion and grew 5% compared to the prior year. In the US, sales were close to $5 billion and grew 7% versus the prior year, rebounding strongly from April lows due to COVID-19 and outperforming the broader anti-VEGF category. ILEA's efficacy, safety, and convenience creates a high bar for current and potential future entries leaving us confident in its durability for years to come. Next, our growth was also fueled by Dupixent, which sold more than $4 billion globally and grew 75% compared to the prior year. In the U.S. alone, more than a million prescriptions for Dupixent were written. Only 6% of eligible U.S. patients have been treated with Dupixent to date. leaving much more room to grow. With regulatory approvals in atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis, and a late-stage development program across eight additional disease types, Tupixin has the potential to transform the treatment of type 2 inflammatory diseases. In oncology, we are pleased that Libtire remains the number one treatment in cutaneous squamous cell carcinoma, In 2020, global net sales were approximately $348 million, representing growth of 80% on further market penetration in the US and from launches around the world. Beyond Liptio, we are emerging as a leader in the development of novel bispecific and other antibody treatments. We now have 12 oncology antibodies in clinical development. Our ability to create a variety of rational combinations using our Velocisuite antibody technologies, positions us well to unlock the next wave of innovation in immuno-oncology. Regeneron also made strides against the infectious diseases in 2020 with the FDA approval of Inmazeb, a monoclonal antibody cocktail, and the first-ever treatment for Ebola virus infection. But nowhere has the power of R&D teams and technologies been more evident than in the discovery and development of our novel antibody cocktail against COVID-19, known as Regencov. In just 10 months, we went from program inception to clinically demonstrating profound antiviral activity, as well as reduction of medical visits, to receiving an emergency use authorization for Regencov in the United States. Most recently, we showed promising data that suggests Regencov reduces transmission of the virus, and prevents infections in patients at high risk of contracting the virus. Importantly, we announced a new supply agreement with the United States government for an additional 1.25 million treatment doses for up to $2.6 billion. Finally, we secured a strategic partnership with Roche to manufacture and commercialize RegenCove globally. These achievements would not have been possible without decades of investment in our innovative antibody-related technologies and our scientific talent, who are a continual source of pride. Regeneron also completed shareholder-friendly actions in 2020, including restructuring our parliament agreement with Sanofi and achieving profitability for the brand in the United States. We also executed the largest ever United States healthcare equity offering with Sanofi's stake in our company. We leveraged our strong balance sheet and historically low interest rates to repurchase $5 billion of those shares, immediately reducing uncertainty and creating significant accretion for our shareholders. We're entering 2021 with strong momentum across our entire business. We expect a number of exciting catalysts this year, including a series of important launches for Libtyo in lung cancer and basal cell cancers to pick some data readouts and launches and milestones for other products that will further enhance our diversity of sales and earnings and position us for sustained financial growth. We are encouraged by the progress we are making against COVID-19 and expect several near-term data readouts for our antibody cocktail that George will outline momentarily. Importantly, our pipeline continues to grow and advance across a wide variety of diseases. Our core business momentum, new launches, and R&D advances positions Regeneron to deliver significant and sustained growth for years to come. Now I will turn the podium over to George.