Regeneron Pharmaceuticals, Inc.

Welcome to the Regeneron Pharmaceuticals 4th Quarter 2018 Earnings Conference Call. My name is Paulette 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 touchtone phone. Please note that this conference is being recorded. I will now turn the call over to Mark Hudson, Senior Manager, Investor Relations. You may begin.

Thank you, Paulette. Good morning, and welcome to Regeneron Pharmaceuticals' fourth quarter 2018 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, chief executive officer, Dr. George Nkopoulos, 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 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, 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 material 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, or SEC, including its Form 10-K for the year ended December 31, 2018, which we are planning to file with the SEC tomorrow. 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 the 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 the call concludes, Bob Landry, Jay Markowitz, and the ARRA 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, Mark, and good morning to everyone who has joined us on today's call and webcast. 2018 marked Regeneron's 30th year anniversary, and it was a remarkable year for the company. We are pleased with our pipeline progress, our commercial execution, and our financial results. And we remain true to our founding mission of inventing important new medicines for patients in need. ILEA, the market-leading anti-VEGF therapy approved across a range of retinal disease, continues to grow. 2018 U.S. net product sales were $4.08 billion, an increase of 10% year-over-year, and 2018 global ilea product sales totaled $6.7 billion, an increase of 14% year-over-year. We continue to invest in retinal diseases and are pursuing new indications, new formulations, and new molecular entities. We have a PDUFA date in May for diabetic retinopathy without diabetic macular edema, or DME, and our submission was based upon our Phase III panorama trial in which we were able to reduce vision-threatening complications of diabetes. In 2018, we made progress fulfilling Dupixent's pipeline in a product promise by showing efficacy in additional diseases and patient populations. The clinical data continue to support our scientific hypothesis that dupixin targets the molecular drivers of allergic and atopic diseases. In its first approved indication, adult atopic dermatitis, dupixin is now annualizing above $1 billion in net product sales in the United States alone. George and Marion will provide more detail, but let me emphasize that we are still in the early stages of the dupixin opportunity with hopefully many more launches in new diseases, geographies, and age groups. Finally, despite the remarkable accomplishments in the nascent field of immuno-oncology, most cancer patients still don't benefit from this approach. We believe that the comprehensive and differentiated strategy that George outlined for you at the JPMorgan Conference is already beginning to deliver on its potential to bring the hope and promise of immuno-oncology to many more patients. In September 2018, Libtyo became the third FDA-approved PD-1 antibody and the first FDA-approved therapy for the treatment of advanced cutaneous squamous cell carcinoma. In December, at the 2018 American Society of Hematology Annual Meeting, or ASH, we presented new data for Regeneron 1979, our wholly-owned CD20 by CD3 bispecific, which we are advancing this year into potentially registrational studies. We simplified and amended our immuno-oncology discovery agreement with our collaborator, Sanofi. In the new agreement, we will continue to collaborate on Libtyo, as well as our MUC16 by CD3 and BCMA by CD3 bispecific antibody programs. For the rest of our immuno-oncology programs, including our co-stimulatory bispecifics, Regeneron retains exclusive rights. In summary, in 2018, we continued to build upon the foundation that we established over the last 30 years, which positions us for future continued success as an innovative biotechnology company. And as I said at J.P. Morgan, after 30 years, all of us at Regeneron feel that we are just getting started. With that, I will now turn the call over to George.