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7/31/2025
Good morning, ladies and gentlemen, and welcome to the Amicus Therapeutics Second Quarter 2025 Financial Results Conference Call and Webcast. At this time, all participants are in a listen-only mode. Later, we will conduct a -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 Fonan, Vice President of Investor Relations. You may begin.
Good morning. Thank you for joining our conference call to discuss Amicus Therapeutics Second 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 is 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 of the call's original date, and we undertake no obligation to update or revise any of the statements. Additionally, you are cautioned not to place undue reliance on any forward-looking statements. At this time, it is my pleasure to turn the call over to Bradley Campbell, President and Chief Executive Officer. Bradley?
Great. Thank you, Andrew, and welcome everyone to our second quarter conference call. I'm very pleased today to highlight our strong quarter and positive outlook for Amicus for the remainder of the year. First, we've delivered yet another quarter of strong double-digit revenue growth on our business in Pompeii and Fabri disease. This is our 17th consecutive quarter with double-digit sales growth at CER, and we see that trend continuing for years to come. Second, we remain highly confident in our growth trajectory that you'll see throughout the remainder of the year. Gallifold delivered 13% -over-year patient growth this quarter and is on track to achieve the highest number of global patient starts this year. For Pombiliti and Opfolda, Q2 marked the strongest quarter for commercial demand since our long launch, with significant momentum both in the United States and the five new launch countries in Europe, as well as the existing launch countries there as well. Third, we're steadily building the body of evidence, highlighting the differentiation of Pombiliti and Opfolda and Pompeii disease, including a recent publication in Muscle and Nerve, which demonstrates the benefits for switching ERT-experienced patients to Pombiliti and Opfolda. Fourth, we are reiterating our confidence that these two products will reach a combined sales of $1 billion by the end of 2028. We continue to believe that Gallifold is uniquely positioned to further its reach as diagnostic rates and patient access continues to improve, offering a substantial runway for sustainable growth, and Pombiliti and Opfolda is becoming an increasingly meaningful contributor to our long-term performance. As a reminder, each of these products have a $1 billion plus in peak sales potential. Fifth, we continue to advance our strategic partnership with Dimerix and DMX200, a -in-class compound in late-stage Phase III development for a rare and life-threatening kidney disease. The Action 3 pivotal study remains on track for full enrollment by the end of the year, marking a key milestone in this important program. DMX200 and our opportunity to meet the significant unmet needs that exist for people living with FSGS is an important new part of the Amicus story, and we look forward to telling you more over the course of the year. And finally, as we continue to maintain our financial discipline, we reiterate that we are on track to achieve gap profitability in the second half of this year. Altogether, we're pleased with our accomplishments this quarter and believe Amicus is in a very strong position to generate meaningful value for our shareholders and deliver on our mission for patients in 2025 and in the years ahead. With that, let me now hand the call over to Sebastien to go through some more detail. Sebastien?
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