Regeneron Pharmaceuticals, Inc.

Good morning, and welcome to the Regeneron Pharmaceuticals first quarter 2019 earnings conference call. My name is Brandon, and I'll be your operator for today. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, during which you can dial star 1 if you have a question. Please note this conference is being recorded, and I will now turn it over to Mark Hudson. You may begin, sir.

Thank you, Brandon. Good morning, and welcome to Regeneron Pharmaceuticals' first quarter 2019 conference call. An archive of this webcast will be available on our website for 30 days under events. Joining me on the call today are Dr. Leonard Schleifer, Founder, President, and Chief Executive Officer, Dr. George Encopolis, Founding Scientist, 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'll open up the call for Q&A. I'd also like to remind you that remarks today made on This call today includes 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, intellectual property, pending litigation, and competition. Each forward-looking statement is subject to risks and uncertainties that can cause actual results and events to differ materially from those projected in that statement. More complete description of these and other material risks can be found in Regeneron's filing with the United States Securities and Exchange Commission, or SEC, including its Form 10-Q for the quarter period ended March 31, 2019, which has been filed with the SEC today. Regeneron does not undertake any obligation to update publicly 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 the 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, Jay Markowitz, 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. Lynch-Leifer.

Thanks, Mark. Good morning to everyone. I lay into PICS and kicked off a successful start to 2019. For the first quarter, total aggregate sales of all Regeneron-evented products were $2.27 billion, a 23% year-over-year increase. We are pleased with the early launch of Liptio, our foundation in immuno-oncology, and we made significant progress across our deep and diverse pipeline. ILEA, which was approved in the U.S. late in 2011, continues to deliver in its eighth year in the market, with U.S. sales of $1.07 billion, a 9% year-over-year increase. I'm proud to say that ILEA's growth has come without price increases. ILEA has an established efficacy and safety profile, with over 25 million injections sold worldwide. In addition to a demographic tailwind in approved indications, we view our pending new approval in diabetic retinopathy as a new opportunity to potentially drive growth. While the potential to prevent patients with diabetic retinopathy from suffering blinding complications is very exciting, we recognize that it will require market development because it involves treating patients that are currently asymptomatic. To test the hypothesis that higher doses may improve upon ILEA's already market-leading profile, later this year we plan to advance into clinical development a high-dose formulation of Aflib Recept, and we continue to make progress on new molecular entities that have the potential to be even better. Let me turn now to Dupixent, the product with the potential to change the course of allergic type 2 diseases. First quarter net sales globally were 374 million, and patient feedback testified to Dupixent's value proposition. We are seeing growth in both atopic dermatitis and asthma, and we expect further growth to be amplified by expanded age groups, new geographies, and additional indications. Moving now to libtio. In its first two quarters on the market, libtio has established a foothold in advanced cutaneous squamous cell carcinoma, or CSCC. We intend to build on that dramatic oncology foundation and expand into other indications. In addition to testing libtio in cancers, in which PD-1 blockade is known to be effective, we consider it an important component of potential future combinations that have the potential to broaden activity and deepen responses. Last month, we announced a collaboration with Alnylam that combines each company's unique assets and abilities and enables us to pursue intracellular targets in the eye and central nervous system, as well as a select number of targets in the liver. This deal exemplifies our business development strategy, and we continue to explore many new and exciting opportunities. Advancing our internal pipeline remains a key priority. Leveraging our scientific capabilities and our world-class genetic efforts and partnering with other scientific-driven companies is yet another way we plan to capitalize on our own research, productivity, and innovation. In summary, our core franchises of ILEA and Dupixent are growing. LibTIO is establishing itself as the foundation of our diversified and comprehensive immuno-oncology platform and has had early commercial success in its first indication. We are advancing a broad and deep pipeline, rich in opportunity for sustainable long-term growth. For more on that, I will now turn the call over to George.