BioMarin Pharmaceutical Inc.

Welcome to the Biomarine second 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, Rob. Thank you, everyone, 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 Biomarine'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 from Biomarin'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 and Chief Financial Officer. I will now turn the call over to Biomart's Chairman and CEO, JJ Bien-Aimé.

Thank you, Tracy, and good afternoon, everyone. Thank you for joining us today on the call. So the first half of 22 is our strongest six-month results to date with over a billion dollars in combined total revenues from our record-breaking first and second quarters. Vox Togo revenues of $54 million in the first half of the year contributed to these results, and they were driven by continued rapid expansion of global commercial access for children with incontrovertible Box logo growth led to today's increase in top and bottom line guidance for the full year, despite ongoing economic challenges, including considerable foreign currency exchange, rate fluctuations, and the strength of the dollar. Turning now to some of the key highlights in the second quarter, all of which were first in our industry. In late June, we were thrilled to have received a positive CHMP opinion for Europe for Roktavian. We continue to expect European Commission approval in the third quarter, which will be opening access to thousands of people with severe hemophilia who are interested in a one-time infusion of Roktavian gene therapy. This will be the first gene therapy to treat any hemophilia recommended for approval in Europe. Jeff and his team are ready to launch Roktavian Potential EC approval later this quarter. And in the U.S., we remain on track to resubmit the BLA by the end of September, the end of next month. Another first was the approval of Arsogo in Japan for children of all ages with achondroplasia and no age restriction. This approval represents our largest commercial opportunity to date in Japan, and we look forward to working closely with the achondroplasia community there. We also received approval in Australia for children ages two years and older. These important additions to the global access footprint are expected to be meaningful contributors with revenues from Japan beginning later this year. With Biomarines financial outlook and robust global launch of Oxogo tracking the plan and obtaining approval on the rise in Europe, 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 opportunity today with Voxogo and then progressing Roktavion to approval in Europe and pursuing approval in the US and also advancing the broadest early stage pipeline in our history. I would add that as compared to where we were a year ago, we have made major progress to substantially reduce regulatory risk for biomarines with the global approval of Voxogo and upcoming approval of Roktavion in Europe. And with our successful launch of Oxogo, the commercial risk is also significantly reduced. We will continue to build on this financial, commercial, and regulatory momentum in the second half of 2022 and beyond as we make the transition to an earnings cold start. Thank you for your continued support, and I will now turn the call over to Jeff to discuss the commercial business updates. Jeff?