11/4/2025

speaker
Conference Operator
Operator

Good morning, ladies and gentlemen, and welcome to the Amicus Therapeutics Third Quarter 2025 Financial Results Conference Call and Webcast. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Mr. Andrew Fonin, Vice President of Investor Relations. You may begin.

speaker
Andrew Fonin
Vice President of Investor Relations

Good morning. Thank you for joining our conference call to discuss Amicus Therapeutics' third quarter 2025 financial results and corporate highlights. Leading today's call, we have Bradley Campbell, President and Chief Executive Officer, Sebastian Martel, Chief Business Officer, Dr. Jeff Costelli, Chief Development Officer, and Simon Harford, Chief Financial Officer. Joining for Q&A, we have Ellen Rosenberg, Chief Legal Officer. As referenced on slide two of the presentation, I would like to remind you that we will be making forward-looking statements on today's call. I encourage you to read the disclaimers in our slide presentation, the press release we issued this morning, and the disclosures in our SEC filings, which are all available on the IR portion of our corporate website. Forward-looking statements are subject to substantial risks and uncertainties, speak only as the call's original date, and we undertake no obligation to update or revise any of the statements. Additionally, your caution not to place undue reliance on any forward-looking statements. At this time, it's my pleasure to turn the call over to Bradley Campbell, President and Chief Executive Officer.

speaker
Bradley Campbell
President and Chief Executive Officer

Bradley? Great. Thank you, Andrew, and welcome, everyone, to our third quarter conference call. I'm very pleased to report another great quarter for Amicus, highlighted by strong revenue growth, gap profitability, and continued confidence in our positive outlook going forward. Let me go through a few highlights before I turn it over to to the team to go through in more detail. First, we delivered another quarter of double-digit revenue growth in our Fabry and Pompei core business, a trend we expect to sustain into the years ahead. Second, we remain firmly confident in our growth trajectory as we approach year end. Galfold delivered 13% year-over-year patient growth this quarter, driven by record demand and robust new patient starts. For Pombility and Opfolda, Q3 represented another strong quarter marked by significant momentum in both our established and newly launched markets, underpinned by growing commercial demand and increasing new patient starts. In fact, this was the strongest quarter ever for new commercial demand for both Gallifold and Pombility and Opfolda. Both products are on track to meet current consensus sales estimates for the full year. Third, we continue to emphasize the growing body of evidence and differentiation of POMBILITY and APFOLDA through scientific publications and Congress presentations. In fact, recently at ICIEM in September, we shared new four-year data from the PROPEL ongoing extension study demonstrating stability or improvement in key endpoints of muscle function and strength in ERT-experienced patients, which Jeff will review in more detail later on the call, along with some exciting new real-world evidence supporting POMBILITY and APFOLDA. Fourth, we reaffirm our confidence that our two commercial products, each with blockbuster potential, are on track to deliver combined sales of $1 billion in 2028. Gallifold's strong growth trajectory, supported by improving diagnostic rates and patient access, coupled with meaningful contribution we expect from Pompility and Upholda to our long-term performance, reinforces our confidence in this milestone. Fifth, Alongside our partners at Dimerix, we continue to advance the development of DMX-200, a first-in-class therapy in late-stage Phase III development for FSGS, a rare life-threatening kidney disease. The Action 3 Pivotal Study is over 90% enrolled and remains on track to complete enrollment by the end of the year. And our work with DMX-200 and the potential to address the considerable unmet need in FSGS represents an important and growing part of the amicus story. And finally, as we continue to maintain our financial discipline, we are pleased to deliver GAAP profitability at a growing cash position in the third quarter and remain very confident in achieving GAAP net income for the second half of the year. Altogether, we are proud of our achievements this quarter and believe Amicus is well-positioned to continue to create significant shareholder value while fulfilling our mission for patients in the years ahead. With that, let me now hand the call over to Sebastian to review the commercial business in more detail. Sebastian?

Disclaimer

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