BioMarin Pharmaceutical Inc.

Good day and thank you for standing by. Welcome to the Biomarin First Quarter 2022 Financial Assault Conference Call. Hosting the conference call today from Biomarin is Tracy McCarty, Group Vice President of Investor Relations. Please go ahead, Tracy.

Thank you, Ashley. Thank you, everyone, 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 programs, actions of regulatory authorities, availability of capital, future actions in the pharmaceutical market, and developments by competitors. And those factors detailed in Biomarin's filing with the Securities and Exchange Commission, such as 10Q, 10K, and 8K reports. On the call today from Biomart Management 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 and Chief Financial Officer. I will now turn the call over to our Chairman and CEO, JJ Bien-Aimé.

Thank you, Tracy. Good afternoon, everyone. Thank you for joining us today. So we begin 2022, of course, for significant growth and the transition to sustainable gap profitability. Interest in Voxogo from families seeking a treatment option that addresses the underlying cause of echocardiopatia has been very positive, as underscored by today's increase in 40-year 2022 Voxogo guidance to between $100 million and $125 million. We also will affirm previously released financial guidance for all other metrics included in our full year 2022 guidance. So we generated 519 million record revenues in the first quarter, representing 11% growth year over year, excluding CUBAN. This marks the start of Biomarine's return to significant double-digit growth. Actually, the revenues for products marketed by Biomarine were up 15% including Kuvax. So really after a strong start to double-digit revenue growth, hopefully over the next few years. So these results highlight the strength of our base business and the significant opportunity that lies ahead with Voxergo. It is important to note that $13 million of the $20 million total for the first quarter for Voxergo sales We are from outside the United States, emphasizing the breadth of our global footprint and commercial capabilities and the importance of the ex-U.S. markets. This will be advantageous as we prepare for the potential European launch of our Procter & Gamble in the second half of this year, ahead of a potential U.S. approval. With the financial outlook and robust global launch of VoxOvo tracking to plan, We look forward to the next important regulatory steps with roctilia and gene therapy over the coming months. For people with severe hemophilia, seeking hemophilia A, seeking B control, that is superior to test therapy or prophylaxis, we think roctilia presents an excellent treatment option based on the results that we observe in our phase 2 and phase 3 studies. We believe this data provides supportive evidence of efficacy as part of the marketing authorization application currently under review in Europe and planned for inclusion in our PLA plan for resubmission in late June. We were also pleased to share the news today that we have completed the genomic analysis of the salivary gland mass from the participants in our Phase II rock david study, which was treated over five years ago. The findings from the completed analysis did not identify evidence that vector integration contributed to the salivary gland mass. This is great news for patients and the safety profile of Octavians and actually for the entire AVG and therapy field. And we'll say a few more words on this in a moment. As we look forward to the remainder of 2022, we are on our way to achieving the goals set forth at the start of the year. turning the corner to sustainable gap profitability, ramping up our largest pediatric opportunity to date with VoxOvo, and progressing routinely in applications with health authorities in Europe and the United States, and also advancing the broadest earnings change pathway in our history. We will continue to build on this financial, commercial, and regulatory momentum in 2022 and beyond as we make the transition to an earnings growth story. So thank you for your continued support, and I will now turn the call over to Jeff to discuss the commercial business update. Jeff.