Regeneron Pharmaceuticals, Inc.

Good morning, and welcome to the Regeneron Pharmaceuticals Third Quarter 2019 Earnings Conference Call. My name is Cheryl, 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. During the question-and-answer session, if you have a question, please press star, then 1 on your touch-tone phone. Please note that this conference call is being recorded. I will now turn the call over to Justin Holko, so you may begin.

Thank you, Cheryl. 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 third quarter 2019 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, founding scientist, 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 this call today 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 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 10Q, for the quarterly period ended September 30th, 2019, 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 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 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.

Thanks, Justin. Thanks to everyone who's joining the call today. We had another great quarter marked by continued execution to deliver double-digit top and bottom line growth. while making progress with our innovative R&D engine. ILEA global net sales grew 14% to $1.9 billion, including U.S. ILEA net sales growth of 16% to $1.2 billion. We continue to build on our leadership position in retinal diseases with market share gains across wet age-related macular degeneration and diabetic eye diseases. Dupixent continued to deliver strong growth while transforming the lives of thousands of patients around the world suffering from a number of type 2 inflammatory diseases. Global net sales of Dupixent are now annualizing at more than $2.5 billion. Launches in atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps are generating broad-based growth for this important brand. We're still in the early days of Dupixent, as approvals around the world continue, and our enthusiasm continues to increase. On the strength of the performance of Dupixent, we generated improved profitability for our antibody collaboration with Sanofi. We expect profits to continue to increase, further diversifying our earnings base, driven by growth in Dupixent, as well as effective cost management across the collaborations. Importantly, our efforts in oncology are bearing fruit in the form of global launches of libtio, our anti-PD-1 therapy in cutaneous squamous cell carcinoma, as well as new data from libtio in lung cancer and our portfolio of innovative biospecific antibodies, including our BCMA antibody in multiple myeloma. We aim to be a leader in immuno-oncology. by bringing important new treatments to patients with both blood and solid tumor cancers. Beyond oncology, we have novel programs that have generated significant late-stage results that we intend to file with regulators, such as evanacumab and homozygous familial hypercholesterolemia. Similarly, results from the PALM study in the Democratic Republic of Congo demonstrated that our antibody combination was superior to the standard of care in preventing death from Ebola in the recent outbreak. We expect further pipeline readouts by the end of the year, as George will speak to in a few moments. Taken together, we continue to demonstrate that Regeneron has the talent and track record to tackle some of the world's most scientifically challenging health issues while creating long-term value for shareholders. We continue to execute on our strategy and as a result, are in a strong financial position. We think carefully about our capital and how to deploy it strategically. As such, we will continue to invest in R&D, as we have shown that those investments have generated significant value for shareholders and for patients. Business development efforts will continue as we seek the best science and capabilities to pair with our own innovations. Beyond R&D, and based upon our confidence in the business to deliver value, both in the short and longer term, we are initiating a $1 billion stock buyback program. These are exciting times for Regeneron. We have strong momentum as we head into the end of the year and into 2020. Now I'll turn the call over to George. Thanks, Len.