BioMarin Pharmaceutical Inc.

Welcome to BioMarin's third quarter 2021 financial results conference call. Hosting the conference call today from BioMarin is Tracy Mockerty, Vice President of Investor Relations. Please go ahead, Tracy.

Thank you, Grace. 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. Research 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 filings with the Securities and Exchange Commission, such as 10Q, 10K, and 8K reports. On the call today from Biomarin Management are JJ Bremen, 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. We hope to keep this call to an hour, so respectfully request that you limit yourself to one question during the Q&A portion of the call. Thank you so much. I will now turn the call over to Biomarines Chairman and CEO, JJ Bien-Aimé.

Thank you, Tracy, and good afternoon, everyone. Thank you all for joining us today. Biomarines Commercial Organization is excited to be launching our seventh commercial product following the August approval in Europe of Vox Ergo for the treatment of achondroplasia for children ages two years and up. I would say that the level of initial prescription demand for patients seeking VoxOgo treatment in Europe has exceeded our expectations. VoxOgo revenues this year will come from France and Germany, where there are a number of children already on therapy, as well as a number of select early access countries in Europe, Middle East, and Africa, and actually also Latin America. As the first and only approved medicine that targets the underlying cause of achondroplasia and improves bone growth in children, we are very pleased with early indicators of product demand. In the U.S., we are in late-stage labeling and post-marketing requirements discussions with the FDA, so we remain encouraged about the potential positive FDA PDUFA action outcome in less than a month now. Adding the U.S. approval would pave the way for our largest global product launch to date, and set the stage for significant revenue growth starting in 2022. Turning to 2021 financials, it is important to understand the dynamics of our global business to appreciate the underlying strength. Despite the impact from anticipated uneven ordering in the first half of the year as compared to what is expected in the second half of the year, we are pleased to be improving full-year top and bottom line guidance. And this despite Kuvan having faced generic competition since the fourth quarter of last year. We actually, despite this, we anticipate generating full year 21 revenues, mostly in line with our 2020 revenues, which illustrates the strength of our base business. This is a result of underlying growth in net product revenues from products marketed by Balmorin, excluding Kuvan, and also continued expense management. The number of patients treated with Balmorin therapies as it has increased this quarter for all our products, other than the Kuvan, of course, and has reached record levels. We expect revenues to rebound in the fourth quarter as compared to the third quarter, so as to end up with a strong finish in 2021. With the addition of Voxhug in Europe and the anticipated U.S. approval, we expect a significant step up in revenues beginning next year in 2022. leading to anticipate the sustainable positive gap income for full year starting next year. We will provide full year 2022 guidance as usual during our fourth quarter quarterly calls on next February. Suffice it to say that our strategy to layer on Voxogo and potentially Octavia into our strong base business, leveraging our global infrastructure and manufacturing capabilities to drive meaningful profitability is rolling out as planned. In support of that plan, cash flows from operating activities increased to nearly $300 million year-to-date and are driving the expansion of Balmain's early-stage pipeline. With six early-stage products on the agenda for our upcoming R&D day, we expect to initiate clinical trials for multiple new products over the coming years. Harnessing genetic technologies to speed our discovery capabilities has resulted in an exponential growth in our critical assets, and we are very excited to share our progress with you on November 30th. So the past 18 months have been challenging for many reasons, the global pandemic, regulatory setbacks, et cetera. But we have remained focused on our mission and goals. Biomarine has never been better positioned to achieve the next level of growth, and we plan to capitalize on the many opportunities that are before us. I want to thank our Biomarine colleagues and associates for their continued commitment to developing the essential medicines that help so many. So thank you all for your continued support. I will now turn the call over to Jeff to discuss the commercial business update. Jeff?