BioMarin Pharmaceutical Inc.

Welcome to the Biomarin Fourth Quarter 2021 Financial Results Conference Call. Hosting the conference call today from Biomarin is Tracy McCarthy, Vice President of Investor Relations. Please go ahead, Tracy.

Thank you, Operator. 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., including expectations 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 Securities and Exchange Commission, such as 10Q, 10K, and 8K reports. On the call today from Biomarin's management team are JJ Vianame, Chairman and Chief Executive Officer, Thank you, President Worldwide Research and Development, Greg Geyer, Executive Vice President, Chief Technical Officer, and Brian Mueller, Executive Vice President and Chief Financial Officer. I will now turn the call over to our Chairman and CEO, JJ Bien-Aimé.

Thank you, Tracy, and good afternoon, everyone. Thank you for joining us on today's call. I think I'm very pleased with our performance and progress in 2021. and also pleased to share our outlook for the year ahead for 2022. So last year, we laid the foundation for our transition to sustainable gas profitability beginning in 2022. The addition of our seventh commercial product, Voxogo, is expected to drive a meaningful step up in revenues beginning this year, as indicated in the increase in full-year 2022 Voxogo revenue guidance announced today. $2.1 billion, or 14% growth year-over-year, represents the midpoint of our 2022 full-year guidance and demonstrates, in terms of revenues, and demonstrates the return to significant double-digit sales growth for BioMoren. It is important to note that our anticipated top-line growth in 2022 is expected, despite the reduction in proven contributions since the loss of exclusivity in the United States in late 2020. This further underscores the strength of our base business and the opportunity that Leisa had with Voxogo, especially considering how early we are in the global launch. Jeff will provide, you know, more details on the launch in a moment, but also I guess you noticed in our release that we generated $5.8 million in Q4 for Voxogo. That was the first quarter that the product was on the market mainly in Europe. And the vast majority of the sales were in Europe, and that does show that once you have the right products, European launches can go up, take off pretty fast. So beyond the strength of our financial outlook and the reverse launch of Voxogo, the recent two-year update from our pivotal study with Roktavion provided further evidence of the transformational nature of GSIP treatment for people with severe The results from our 134-subject people study that we shared in January demonstrated durable, consistent bleeding control with annualized bleeding rates reduced by 85 percent and with 95 percent of participants remaining off-factor-rate prophylaxis therapy through two years. To those people with severe hemophilia seeking bleeding control that is superior to standard We believe roctavian represents a very attractive treatment option, and based on the results observed in our Phase II and Phase III studies, we believe that this data will provide supportive evidence of efficacy as part of the review currently underway in Europe, as well as the VLA we intend to resubmit in the U.S. in June. To summarize, we have set the stage for transformational growth for the company and the people we seek to treat. In 2022, we expect to turn the corner to sustainable gap profitability, wrap up our largest pediatric opportunity to date with Voxogo, advance our applications to Europe and the United States with Rokitian, and see the progress of the broadest early-stage pipeline in the history of Biomarin. The financial, commercial, and regulatory momentum at Biomarin I've never been stronger and we want to thank you for your continued support throughout our foundation building journey. I especially want to thank our Biome Wing colleagues for their continued commitment to developing the essential medicines that help so many. So we'll now turn the call over to Jeff to discuss the commercial business update. Jeff?