Regeneron Pharmaceuticals, Inc.

Ladies and gentlemen, thank you for standing by, and welcome to the Regeneron Pharmaceutical Q2 2020 Earnings Conference Call. At this time, all participant lines are in a listen-only mode. After this week's presentation, there will be a question and answer session. To ask a question during this session, you'll need to press star 1 on your telephone. Please be advised, today's call is being recorded. If you require any further assistance, please press star 0. Thank you. Justin Hoko, I will now turn the call over to you.

Thank you, Stephanie. 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 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 Giancopoulos, co-founder, president, and chief scientific officer, Mary 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 businesses, 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 the 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 quarterly period ended June 30, 2020, which has been filed with the SEC today. Regeneron does not undertake any obligation to update any forward-looking statement, 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. 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 for joining the call. I hope all of you are staying safe and well. We very much appreciate your efforts to join, given the pandemic conditions and even, on top of that, in Northeast, some power disruption from the storm. But business continues. We had an eventful and productive second quarter in terms of financial results, business development, and corporate accomplishments. In the second quarter, our results demonstrated resilience and strength despite the impact of the ongoing COVID-19 pandemic. In addition to driving double-digit top and bottom line growth, we continue to deliver meaningful advances in our broad and innovative pipeline, as well as in our fight against COVID-19 with our novel antibody cocktail. Regeneron continues to execute well in this unprecedented time for our company, our nation, and the world. Starting with our products, ILEA global net product sales were $1.75 billion in the second quarter, a modest decline of 6% compared to the prior year. In the U.S., we generated sales of $1.11 billion with a pronounced and sustained rebound in demand in May and June following the decline in sales we experienced in early April. This rebound has continued into July, and demand is now approaching pre-COVID levels. The efficacy, safety, and convenience of ILEA have proven to be even more valuable in the world of COVID-19. As you will hear from Marion, ILEA outperformed the broader anti-VEGF class this quarter. Demand for Dupixin also proved to be robust in the second quarter, with global sales growth of 70% compared to last year. Sales were nearly $1 billion on continued market penetration in atopic dermatitis, asthma, and new launches. Adding to the Dupixin momentum, the FDA approved a new indication for atopic dermatitis in children aged 6 to 11. Furthermore, we demonstrated dramatic results in eosinophilic esophagitis, where patients reported a nearly 70% reduction in symptoms, further exemplifying the potential of dupixin to bend the arc of certain type 2 inflammatory diseases. We look forward to additional Dupixent milestones, including an upcoming Phase III readout in pediatric asthma and enrollment of a second Phase III study in chronic obstructive pulmonary disease. We and our patients and customers have a tremendous amount of enthusiasm for this product, and we are still in the early days of unlocking its full potential with our partner, Sanofi. In oncology, libtio is the leading systemic treatment for cutaneous squamous cell carcinoma. We are seeking approvals in basal cell carcinoma and non-small cell lung cancer with regulatory filings to be submitted imminently. With our chemotherapy combination study in non-small cell lung cancer nearing full enrollment, our excitement for libtio continues to grow. Beyond libtio, we are broadening and advancing our bispecifics portfolio, generating further momentum for our oncology strategy. Turning to our efforts to fight COVID-19, we are advancing the development of a novel antibody cocktail known as REGN-CoV-2. that may both treat and prevent infection from the SARS-CoV-2 virus. We are now in phase two and phase three trials and hope to generate initial data by the end of September, as George will discuss in further detail. We also signed two major agreements in recent weeks. We announced a $450 million agreement with BARDA and the U.S. Department of Defense to manufacture REGN-CoV-2. We also signed a six-year $345 million agreement with BARDA for our novel Ebola antibody cocktail, further demonstrating the potential of our end-to-end technologies to deliver shareholder value in addressing infectious disease threats. Finally, on the corporate front, we completed a large secondary offering of more than 13 million shares of our common stock held by Sanofi. Using our strong balance sheet, we also repurchased $5 billion, or 9.8 million shares from Sanofi, effectively eliminating their ownership position in our company and demonstrating our confidence in the trajectory of our business. For Regeneron shareholders, this transaction provided immediate accretion and removed a significant overhang related to the expiration of Sanofi's lockup period at the end of this year. Regeneron is a business that is indeed firing on all cylinders. We thank all of our colleagues across the company who have been working with resolve and resilience in these extraordinary times of the pandemic. Our strong business performance, cash flow, balance sheet, and advancement of the next generation of innovations for important medical needs has us positioned to weather COVID-19 and emerge from the pandemic to drive continued long-term growth. Now I'll turn the call over to George. Thank you, Lorne.