Amicus Therapeutics, Inc.

Good morning, ladies and gentlemen, and welcome to the Amicus Therapeutics third quarter 2024 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 now begin.

Good morning. Thank you for joining our conference call to discuss Amicus Therapeutics third quarter 2024 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 Ghiselli, Chief Development Officer, and Simon Hartberg, Chief Financial Officer. Joining for Q&A is Ellen Rosenberg, Chief Legal Officer. As referenced on slide two, we might make forward-looking statements within the meaning of the private securities litigation reform of 1995 relating to our business as well as our plans and prospects. Our forward-looking statements should not be regarded as a representation by us that any of our plans will be achieved. Any or all the forward-looking statements made on this call may turn out to be wrong and can be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. You are cautioned not to place undue reliance on any forward-looking statements which speak only to the date you're of. All forward-looking statements are qualified in their entirety by this cautionary statement and we undertake no obligation to revise or update this presentation and conference call to reflect events or circumstances after the date hereof. For a full discussion of such forward-looking statements and the risks and uncertainties that might impact them, we refer you to the forward-looking statements and risk factors section on our annual report on Form 10-K for the year ended December 31st, 2023 and the quarterly report on Form 10-Q for the quarter ended September 30th, 2024 to be filed with the Securities and Exchange Commission today. 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, everybody, to our third quarter 2024 conference call. I'm pleased today to highlight what has been a very successful nine months of the year across our global business, and in particular, another very strong quarter in Q3. In this time, we've continued to build on our top-line revenue growth momentum, putting us well on our way to our first full year of non-GAAP profitability, while also advancing our mission of bringing hope to individuals and families affected by rare diseases. As we did in this morning's press release, let me just highlight several key points here. First, we continued our excellent commercial execution and delivered total revenue of $142 million, in the quarter, representing 37% growth year-over-year or 36% on a constant currency basis. This strong performance has led us to increase our total revenue guidance for the full year to 30% to 32% from 26% to 31% previously. At the product level, Gallifold continues its outstanding performance with $120 million in global revenue in the quarter, which represents 19% growth from last year on a constant currency basis. On a year-to-date basis, Gallifold revenue growth was 18% year-over-year at constant exchange rates, coming in at the high end of our guidance for this year. We continue to observe strong trends across our key performance indicators for Gallifold and all key geographies in the quarter, including continued demand through new patient starts from both switch and naive populations in all of our leading markets, and sustained compliance and adherence rates of over 90%. All of this, of course, is against the backdrop of significant growth in people diagnosed with and treated for febrile disease. We are extremely pleased by the significant difference this medicine continues to make for people living with febrile disease with amenable variants in countries around the world, and we see it serving as the foundation of our business for the next decade and beyond. Based on Galfold's sustained performance, we're also increasing our full-year 2024 revenue growth guidance range for a third time this year, We started the year with a growth range of 11% to 16%, and now we're projecting Gallifold growth of 16% to 18%. An important update we announced during the quarter as well was the license agreement with Teva, one of the lead parties in our ongoing IT litigation. This agreement allows Teva to market a generic version of Gallifold in the United States beginning on January 30, 2037. This settlement reinforces our high confidence in the strength of our case against the remaining litigants as well as the overall strength, breadth, and depth of our IP estate. And this is a huge milestone for amicus. It represents a major step forward in ensuring amicus can continue to support the Fabry community with Gallifold for many years to come. Second, let me highlight the continued strong global commercial launch of Pompility Not Folda, our novel therapy for late onset Pompe disease. Pompility Not Folda, of course, has continued to be a huge driver of growth for us this year. And as we've mentioned, our number one focus continues to be maximizing the number of patients on therapy by year end. Therefore, it's great to report that the rate of new commercial patients coming on to Pompility on Folda in 2024 continues to progress exceptionally well. As of the end of October, there were 203 people living with late-onset Pompe disease treated or scheduled for treatment. And we continue to see the breadth and depth of prescribers increasing across our markets. We're very pleased with the demand globally for this new therapy. and consistently hear inspiring anecdotes from healthcare professionals around the world on how their patients are responding to pombility on Folda, which will help keep fueling the launch throughout the remainder of this year and beyond. We're continuing to build momentum in our launch countries with strong switch dynamics in the U.S., Europe, and the U.K., as well as seeing great uptake in the naive patients in the market outside the United States, And we're also making significant progress on the reimbursement front globally. This includes moving patients more quickly through the insurance process in the United States, as we've anticipated. And for the remainder of the year and into 2025, we will focus on increasing patient access as we gain reimbursement and launch in additional countries throughout Europe. On the regulatory front, we're continuing to make great progress on expanding commercial access to Pompili Now Folda through our multiple regulatory submissions as well. Given the strong global launch for the full year 2024, we are now raising our full year global sales guidance to $69 to $71 million in Pompility and Upsolda, which will be a significant contributor to our growth. This sets us on a great course to achieve our ambition for POMOP to become the new standard of care for this devastating disease. We're incredibly pleased to be providing a real choice for people living with Pompe disease and challenging therapeutic expectations for both physicians and their patients. Finally, as we continue our excellent commercial execution across both therapies, we're pleased to share that we are reducing our non-GAAP operating expenses guidance as we continue to judicially manage our expenses. Throughout the first nine months of the year, we've exceeded our financial expectations, which as I mentioned in this morning's press release, has resulted in achieving our goal of full-year non-GAAP profitability as we close the third quarter. And finally, let me touch on slide four, our key strategic priorities for the year. Again, sustaining double-digit Gallifold revenue growth. And as I mentioned, we've raised the expected annual growth rate of Gallifold to 16% to 18%. Continuing to successfully execute multiple commercial launches of Pompidou and Alphoda. And again, we've raised our guidance there as well. Advancing ongoing studies to support medical and scientific leadership in Fabry disease and Pompe disease. And finally, maintaining a strong financial position as we carefully manage our expenses and investments to achieve non-GAAP profitability for the full year. With that, let me now hand the call over to Sebastian, who can further highlight our commercial performance. Sebastian.