BioMarin Pharmaceutical Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Biomarin Third Quarter 2020 Financial Results Conference Call. Hosting the conference call today is from Biomarin Tracy McCarthy, Vice President of Investor Relations. Please go ahead, ma'am.

Thank you, Joanna, and thank you all for joining us today. To remind you, this non-confidential presentation contains forward-looking statements about the business prospects of Biomarin Pharmaceutical Inc., regarding Biomarin's financial performance, commercial products, and potential future products in different areas of therapeutic research and development. Results may differ materially depending on the progress of Biomarin's product program, actions of regulatory authority, availability of capital, future actions in the pharmaceutical market, and developments by competitors. And those factors detailed in Biomarin's filings with the SEC, including 10Q, 10K, and 8K reports. On the call remotely, well, some are remote and some are sitting here together, are from Biomarin Management today, JJ Piename, Chairman and Chief Executive Officer, Jeff Ager, Executive Vice President, Chief Commercial Officer, Hank Fuchs, President, Worldwide Research and Development, Greg Guyer, Executive Vice President, Chief Technical Officer, and Brian Mueller, Executive Vice President, Chief Financial Officer. We hope to keep this call to one hour, so we respectfully request that you limit yourself to one question during the Q&A portion of the call. Thank you for your understanding. I will now turn the call over to Byron's Chairman and CEO, JJ Bien-Aimé.

Thank you, Tracy. Good afternoon, and thank you all for joining us on today's call. We hope you and your families have been well during these uncertain times. It is hard to believe that we are around the month nine of the global COVID-19 pandemic. So like many of you, we are ready for a reset and a fresh start in 2021, but our commitment to providing innovative treatments to people with serious conditions keeps us focused day to day. Indeed, BioLorin faced some challenges in the third quarter, and the results have been strengthened conviction in our mission and renewed motivation to achieve it. The most anticipated milestone of the year The advancement of Rotarian gene therapy for the treatment of severe hemophilia and Rosoritide for the treatment of achondroplasia each reached a key inflection point in their progression during the quarter. Rosoritide applications in the U.S. and Europe were accepted for review by health authorities and are in process for potential approval in 2021. With the CHMP opinion expected in the second half of next year, and the U.S. Bidoof Action Dates planned for August 20th of next year. The community of parents with children who have Echondroplasia and want a treatment option are that much closer to accessing the first potential pharmacological therapy tool for this condition. With six highly innovative products developed, approved and commercialized for a variety of rare conditions over the last two decades, This is familiar and gratifying territory for BioMarin. Turning to Roktavion, one of the most innovative products we have developed. We have transitioned to a more traditional regulatory timeline than originally anticipated for this one-time gene therapy infusion that helps control bleeding in people with severe hemophilia A. As is typical for BioMarin, we pursued an accelerated development strategy with Roktavion which resulted in the significant advancement of the field and greater awareness of gene therapy as an important new therapeutic platform for the treatment of hemophilia A. And while this platform has been at the research stage for decades, the speed with which Biomarin brought Roktavion forward for regulatory review was unprecedented even for us. Our belief in the therapeutic benefit of Roktavion for our patients has not wavered. The complete one-year phase three data from all 134 patients are paramount to determining next steps, and we look forward to sharing those top-line results with you in early 2021. Based on the vision control observed to date with Roktavion, we have confidence in the approval and patient interest in this product. In a moment, Hank will provide more details on our plans over the coming months. Briefly on third quarter financial results, I have been impressed with the commitment of our commercial and manufacturing organizations in the face of the seemingly never-ending impact of COVID-19. They have not missed a beat. Our ability to execute under the limitations imposed by the global pandemic remains a testament to the importance of our therapies. Also, our diversified product base and far-reaching commercial footprints. Jeff will provide details of the quarter and updates on 2020 guidance in a moment. We have met the adversity of 2020 with versatility and agility. In what has been the most unpredictable year we have experienced so far at Bahamrin, the resilience of our business and fortitude of our employees has consistently shown through. As a result, we remain well positioned for substantial growth as we focus on the execution of our Global Opportunities with Octavian and Rosoritide, as well as other key pipeline products. And we want to thank you for your continued support. Now, I would like to turn the call over to Jeff to discuss the commercial business update. Jeff?