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5/1/2025
Good day, everyone, and welcome to the Biomarin Pharmaceutical first quarter 2025 conference call. Just a reminder that this conference is being recorded. I would now like to hand things over to Ms. Tracy McCarty. Please go ahead, ma'am.
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 10Q, 10K, and 8K 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 press release and earnings presentation, both of which are available in the investor relations section of our website. Please note that our commentary on today's call will focus on non-GAAP financial measures, unless otherwise indicated. 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, Chief R&D Officer. 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 first quarter 2025 results update. We are pleased to have delivered strong financial performance and revenue growth of 15% in the quarter. On the bottom line, non-GAAP earnings per share of $1.13 represented a 59% year-over-year increase reflecting significant profitability expansion, nearly four times the rate of top line growth. This performance highlights the fundamental value of our transformative medicines and the strength of our business, both of which are key attributes that distinguish Biomarin. These results pave the way for record full year performance in 2025 and boost cash generation for reinvestment in innovation and expansion. Last September, we announced changes to Biomarin's strategy and operating model. Since that time, we have been focused on implementing these changes while at the same time delivering strong growth and profitability. Looking ahead, we expect to see the continued implementation and benefits of this transformation deliver even stronger results and innovation in the coming quarters and beyond. Turning briefly to external dynamics impacting the sector, we believe Biomarin is well positioned to manage through uncertainty across a number of areas. As the preeminent innovator of medicines that treat rare conditions, Biomarin is less exposed to macroeconomic conditions impacting other sectors. Because so many of our medicines are treatments for children, we have limited exposure to policies impacting Medicare. which covers roughly only 2% of our U.S. patient population. In addition, BioMarin's core fundamentals also provide a level of insulation from external unknowns. Increasing cash generation, our extensive global revenue base, with approximately two-thirds of our total revenues originating from outside the United States, along with our established global commercial, regulatory, and manufacturing capabilities position us well in an evolving and dynamic market environment. Moving to the specific uncertainties around potential pharmaceutical tariffs, we are analyzing potential exposure and mitigation tactics under multiple scenarios. As BioMarin's medicines address relatively small patient populations around the world, we manufacture products that address these rare indications in single locations, either in the U.S. or Europe. Based on our current understanding, we believe that the global scope of our business model with approximately two-thirds of total revenues generated from outside of the United States and a significant level of U.S.-based manufacturing will provide some protection from potential tariff impacts should innovative medicines for rare conditions be targeted. Important to note, Biomarin has immaterial exposure to U.S. tariffs for China, Mexico, and Canada. across its global supply chain operations and product sales. Turning now to potential new products and expansions, we're making good progress on our innovation strategy. I am pleased to share that we recently completed enrollment in our pivotal phase three study with VoxOgo in children with hypochondriplasia, paving the way for a potential launch in 2027. With Palantzeek, based on the positive pivotal data We announced in April we are on track to submit applications in the second half of this year in the United States and Europe for the treatment of adolescents. In addition, we expect to share early clinical results later this year from both BMN351 for Duchenne muscular dystrophy and BMN333, a long-acting CNP. Two candidates. that may provide highly differentiated treatment options for the conditions they target. Finally, we expect to fortify our internal innovation with business development, as we feel that Biomarin's established global capabilities, coupled with the external environment, create opportunities that will support our growth agenda. In summary, we believe we are well positioned to manage through ongoing market uncertainty based on the global demand for our innovative medicines. Through Biomarin's strategic transformation implemented over the last year, we have set ourselves up to deliver significant value creation for all our stakeholders in 2025 and beyond. Thank you for your attention. I will now turn the call over to Brian to provide our financial highlights for the quarter.
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