BioMarin Pharmaceutical Inc.

Thank you for standing by. My name is Bailey and I will be your conference operator today. At this time, I would like to welcome everyone to the Biomark Pharmaceuticals third quarter 2024 conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, again, press star and 1. I would now like to turn the call over to Tracy McCarty, Group Vice President of Investor Relations. You may begin.

Thank you, Operator. 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 filings with the Securities and Exchange Commission such as 10-Q, 10-K, and 8-K reports. In addition, We will use non-GAAP financial measures as defined in Regulation G during the call today. These non-GAAP measures should not be considered in isolation from, as substitutes for, or superior to financial measures prepared in accordance with U.S. GAAP, and you can find the related reconciliations to U.S. GAAP in the earnings release and earnings presentation, both of which are available in the investor relations section of our website. On the call from Biomarin Management today are Alexander Hardy, President and Chief Executive Officer, Brian Mueller, Executive Vice President, Chief Financial Officer, Kristen Hubbard, Executive Vice President, Chief Commercial Officer, and Greg Freiberg, Executive Vice President, Worldwide R&D. I will now turn the call over to Biomarin's President and CEO, Alexander Hardy.

Thank you, Tracy, and good afternoon, everyone. Thank you for joining us today for our third quarter 2024 earnings call. The strategic and operational decisions we have made over the last nine months are driving strong performance, and I'm pleased to report another quarter of record financial results with revenues reaching $746 million, marking a robust 28% increase compared to the same period in 2023. As outlined at Invest Today, we're implementing our new corporate strategy focused on innovation, growth, and value commitment. During the quarter, we made significant progress on each of these pillars, resulting in strong performance. We are structuring the company around new business units in skeletal conditions, enzyme therapies, and roctavian to drive accountability, deliver stronger revenue growth, and improve efficiency. while reaching a growing number of patients around the world. We have set this company on the path to stronger performance, and these results are evidence of our progress. Today, I'm also delighted to welcome Greg Freiberg and James Sabre to Biomarin. With Greg and James in role and the addition of Kristen Hubbard earlier this year, we have incredible strength and depth in our leadership team. with the right combination of scientific and business acumen. I'm confident that with these leaders in place, we are positioned to deliver the new strategy and innovate across all aspects of our business. Greg and Kristen will provide their updates on the call in a moment. Moving to the results in the quarter, strong financial performance was driven by a 50% revenue growth in Voxogo for the treatment of achondroplasia. This growth was supported by a significant level of new patient starts driven by increased penetration in the U.S. and new geographies that leveraged our broad geographic footprint and capabilities. The growth is also being driven by our expanded indication into infants and the increasing evidence of VoxOgo's benefits to the health of patients beyond height. As our global launch of Vox Ergo for achondroplasia continues to gain momentum worldwide, we have confidence in our sustained leadership across our skeletal conditions franchise over the long term. Our proven capabilities of diagnosing, treating, facilitating market access, and building the achondroplasia therapeutic area provide Biomarin the unique ability to sustainably lead this global market. The five key reasons supporting our confidence in growing and maintaining the achondroplasia market are, first, a potential five-year commercial lead, including the largest database in achondroplasia of long-term durable efficacy and greater than 6,000 patient years of safety, and an emerging data set on benefits beyond height, including quality of life. Second, global approvals from infancy, and our plans to continue to deeply penetrate this market segment, along with complicated potential switch market dynamics. The U.S. and EU markets comprise approximately 32% of the global total addressable patient population, and therefore the majority, 68%, is more insulated from midterm competitive threats because of our global capabilities and market leadership. Third, our global commercial medical and market access capabilities, built over 20 years, as just described. Fourth, the prioritization and acceleration of BMN 333, our long-acting CNP that leverages the same CNP as Voxogo. And fifth, our plans to vigorously defend our intellectual property. In summary, We maintain our confidence in the long-term growth potential of our Skeletal Conditions franchise. Beyond Skeletal Conditions, our global enzyme therapies portfolio continued to perform well and grow in the third quarter, with 27% revenue growth in Q3 and 13% year-to-date growth. Q3 enzyme therapy revenue benefited from increased algerazine revenue as we delivered a substantial amount of product to Sanofi during the quarter. Excluding the algerazime revenue, the enzyme therapies still grew at close to 10% year-to-date. We're starting to deploy the new initiatives outlined at Investor Day, and these, together with a focus from the business unit structure, give us confidence that we can grow this portfolio even faster than historical rates. We're pleased today to raise four-year guidance at the midpoint for all items driven by our strong ongoing execution and focus on performance. Alongside record revenues, we have driven considerable profitability expansion with year-to-date non-gap EPS growing more than three times faster than revenue. As a result of our focused cost transformation program and leveraged revenue growth, we continue to drive substantial expansion of our operating margin. Our strong financial performance reinforces our confidence in reaching our midterm and long-term outlook, provided we invest today. Today, we are reaffirming our long-term guidance and outlook, which include achieving approximately $4 billion in total revenues by 2027, reaching 40% non-GAAP operating margin starting in 2026, and growing to the low mid 40% range over time. Generating more than 1.25 billion in operating cash flow per year, starting in 2027. Targeting a mid-teen compound annual growth rate for total revenues through 2034. Developing potential treatments for skeletal conditions that represent a greater than $5 billion revenue opportunity over time. And as a reminder, this $5 billion opportunity assumes only a very modest penetration into the skeletal conditions indications. In summary, our third quarter performance highlights the ongoing execution of our corporate strategy under Biomarin's new operational plan to achieve sustained and significant returns. These results should demonstrate our commitment to superior performance, resulting from our laser focus on making an impact on the life of each patient we serve. I would like to thank our employees around the world for all of the work they've done during the third quarter to contribute to this progress and to their commitment to continuing to evolve the way we work to support the new strategy. Thank you for your attention. I will now turn the call over to Brian to provide an overview of our financial highlights for the quarter.