BioMarin Pharmaceutical Inc.

Welcome to the Biomarine Third Quarter 2022 Financial Results Conference Call. Hosting the conference call today from Biomarine is Tracy McCarty, Group Vice President of Investor Relations. Please go ahead, Tracy.

Thank you, Ross, and thank you all for joining us today. To remind you, this non-confidential presentation contains forward-looking statements about the business prospects of Biomarine 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 authorities, 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 from Biomarine's management team today are JJ Bien-Aimé, Chairman and Chief Executive Officer, Jeff Ager, Executive Vice President, Chief Commercial Officer, Hank Fuchs, President Worldwide Research and Development, Greg Geyer, Executive Vice President, Chief Technical Officer, and Brian Mueller, Executive Vice President, 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 today. Primary results in the first nine months of 2022 represent a record year-to-date total revenues of more than $1.56 billion. In the third quarter, total revenues grew 24% year-over-year and increased 31%, excluding Kuvan. VoxLogo revenues of $48 million in the third quarter and $102 million year-to-date led to today's increase in full-year 2022 VoxLogo guidance. Driving this impressive result is continued strong demand from across Europe and the United States for Voxogo, a significant increase in overall patients treated, and notable uptake in Japan since launching there in August. With no lower age restriction on Voxogo treatment in Japan, we are thrilled to share that one of the first patients treated in the third quarter was a three-week-old baby. Turning on to our second and most recently approved large product opportunity, Roctavian, gene therapy for the treatment of hemophilia A. Since receiving European approval in the third quarter, we are now in the final stages of negotiating outcome-based agreements, or OBAs, with the key payers in Germany, and with Roctavian pricing in Germany, listed and labeled commercial products in our warehouse and ready to ship, we expect to treat the first patients there in the fourth quarter. And in additional, EU countries beginning in the first quarter of next year. Jeff will provide an update on the European launch in a moment. Briefly on Rockhaven in the United States, the BLA is under review. We were very pleased to have received acceptance of the BLA from the FDA two weeks ago and with a PDUFA date of March 31st, 2023. The FDA also recently informed us that they plan to hold an advisory committee meeting. As we have said before, we have been preparing for a potential outcome for some time. We believe it is a good opportunity to discuss the demonstrated clinical benefits and established safety profile of Octavian from the largest gene therapy clinical program ever conducted. As we near the end of 2022, I am awestruck by what has been accomplished in the last 12 months At the top of the list is our transition to profitability and the approval of our two largest product opportunities. Voxelgo approvals last year enabled the most successful portal launch in the history of the company and underscored our capabilities across research, development, regulatory, commercial, and manufacturing. Navigating the same capabilities, we intend to extract maximum value from Roktavion beginning with our European launch this quarter. I want to thank my colleagues for their contributions to achieving those significant milestones, which have solidified our foundation for growth. We will build on this momentum for the remainder of 2022 and beyond as we complete our transition to an earnings growth story. A unique accomplishment in our industry. For sure. Thank you for your continued support. And I will now turn the call over to Jeff to discuss the commercial business updates. Jeff.