Regeneron Pharmaceuticals, Inc.

Welcome to the Regeneron Pharmaceutical Second Quarter 2021 Earnings Conference Call. My name is Tamiya, 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 will now turn the call over to Justin Houkou, Vice President, Investor Relations. You may begin.

Thank you, Tamia. 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 second quarter 2021 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, 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, as well as 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 June 30, 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 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 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.

Thank you, Justin, and thanks to everyone joining today's call. We had an outstanding performance across the enterprise in the second quarter. Not only did our base business perform exceptionally well with strong growth from ILEA, Pixin, and Liptayo, but we also delivered 1.25 million doses of Regencov to the United States government, fulfilling the entire supply contract with BARDA. We also continued to advance multiple programs across our innovative R&D pipeline with several important readouts. Starting with ILEA, global net sales were over 2.3 billion, growing 33% compared to the prior year, reflecting recovery from the COVID pandemic impact on the second quarter of 2020. In the U.S., sales grew 28%. ILEA continues to set a high bar in terms of efficacy, safety, and convenience. Dupixent also performed exceptionally well this quarter with global sales of $1.5 billion and growth of 59%. This quarter also marks the first time we in Santa Fe exceeded $1 billion in U.S. Dupixent quarterly net sales. There remains considerable room for further growth from our inline indications as well as from potential new opportunities. such as in chronic spontaneous urticaria, or CSU, where last week we announced positive Phase III study results. We have additional Phase III readouts in parigonodularis, eosinophilic esophagitis, and pediatric atopic dermatitis later this year, which could advance our conviction of Tupixin as a pipeline and a product to address numerous inflammatory diseases. In oncology, Liptio global net sales were 117 million and grew 46% with meaningful growth contributions from both inside and outside the United States. We also announced this morning that in a large phase three pivotal study in non-small cell lung cancer, Liptio combined with standard chemotherapy reduced the risk of death by nearly 30% compared to chemotherapy alone. We are eager to share these data with regulatory agencies, which, if approved, would dramatically increase the number of lung cancer-eligible patients who could be treated with Liptio. We also began to see meaningful results from our Regeneron genetics medicines pipeline. With our collaborators at Intelia, we showed the first-ever proof of concept in vivo gene gnome editing with NTLA-2001, and investigational CRISPR therapy for transthyretin amyloidosis or ATTR amyloidosis. This proof-of-concept study utilizing systemically administered CRISPR technology for genome modification suggests this approach could have broad applicability across a wide range of diseases. Beyond Intelia, our collaborations with Alnylam and Decibel are helping to form a whole new pipeline of next-generation therapies beyond our broad and diverse antibody pipeline. The second quarter represented another landmark in our efforts to combat COVID-19, which unfortunately, despite considerable rates of vaccination, continues to be a major global health concern, with rising cases and emerging variants. In addition to fulfilling our entire supply contract with the United States government, we were able to secure emergency use authorization updates for our lower 1.2 gram subcutaneous dose, as well as for post-exposure prophylaxis for certain appropriate patients who are at high risk for disease. Utilization is increasing rapidly at currently more than 50,000 doses ordered per week. We also announced that the UK recovery study showed a 20% reduction in risk of death in hospitalized patients who had not mounted their own immune response. With these results, together with supporting data from Regeneron's study in hospitalized patients that George will discuss momentarily, RegenCOVE has the potential, if so authorized, to be the first treatment for use in a wide spectrum of COVID-19 disease settings from prevention, through the hospitalized setting. In summary, our core business is strong and continues to diversify, and our innovative pipeline continues to advance, positioning Regeneron well for long-term growth. Now I will turn the call over to George.