BioMarin Pharmaceutical Inc.

Thank you for joining BioMarine's second quarterly results conference call. Hosting today's call from BioMarine is Tracey McCarthy, Head of Investor Relations at BioMarine. Please go ahead, Tracey.

Thank you, JP, and 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 programs, actions of regulatory authorities, availability of capital, future actions in the pharmaceutical market, and developments by competitors. And those factors detail in Biomarin's filings with 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, Commercial Chief Technical Officer, Brian Mueller, Executive Vice President, and Chief Financial Officer. I will now turn the call over to Biomarin's Chairman and CEO, JJ Bien-Aimé.

Thank you, Tracy, and good afternoon, everyone. Thank you for joining us today on this call. We were very pleased with our progress in the second quarter as more families around the world gained access to VoxOgo and the highly anticipated FE approval of Roktavion was received. The achievement of these two milestones are key components of our growth plans, including continued VoxOgo expansion and Roktavion launch execution. Record revenues of approximately $1.2 billion in the first half of the year represented 13% year-over-year growth and 16% growth excluding CUBA. Our commitment to profitability was demonstrated again this quarter, and we were pleased to deliver $56 million in gap net income as a result of strong product demand. With Q2 total revenues coming in at $595 million, including $113 million in Vox Ergo revenues, we are on a path to achieving our 2023 objectives of double-digit revenue growth and significant operating leverage. This is expected to drive more than 30% growth in bottom-line profitability in 2023, as communicated earlier this year. We were very pleased to have received FDA's approval of Roktavion in April, as we believe the demonstrated clinical benefits of this one-time gene therapy has transformative potential for those living with severe hemophilia and eligible for treatment. With combined U.S. and European addressable patient population of nearly 6,000 patients, we are optimistic that Roktavion will become the treatment of choice for those seeking an alternative to chronic therapy. The commercial team moved quickly to activate the first phase of launch following FDA's approval, and we have been encouraged by the early signals of interest in Roktavion in the United States. We have also made good progress in Germany and other European countries during the quarter, and Jeff will provide more launch details in a moment. Turning to Voxogo, we continue to be impressed by the cadence of uptake worldwide. As a result of continued strong demand, we are raising full-year Varg Sogo guidance for the second time this year to between $400 and $440 million, representing a significant increase from our initial guidance in February of between $330 million and $380 million. Jeff will provide additional detail on our Varg Sogo guidance in a moment. Building on the significant demand for Varg Sogo for the treatment of achondroplasia, we are pleased to offer Announce today plans to begin our pivotal program with VoxSorgo for the treatment of hypochondrioplasia. With over seven years of efficacy and safety data from our clinical program and nearly two years of commercial experience in hypochondrioplasia, we view VoxSorgo as highly de-risked and now on the fast track in its potential second new underserved patient population. Hank will provide more details in a moment, but suffice it to say we are rapidly executing on our expansion plans with VoxOvo. In summary, we are very pleased with Biomin's performance in the second quarter and year today. The global demand for VoxOvo continues to drive record revenue and market expansion, supporting our confidence that it will be our first blockbuster product. With Rokavian, we're excited about the opportunity ahead and remain focused on launch execution, both in the United States and Europe. Our ability to raise awareness among patients and physicians in the U.S. through direct outreach to the HEMO-CIA community will result in meaningful demand over the coming course. Thank you for your continued support, and I now will turn the call over to Jeff to discuss the commercial business updates.