Amicus Therapeutics, Inc.

Good morning, ladies and gentlemen, and welcome to the Amicus Therapeutics Second Quarter 2024 Financial Results Conference Call and Webcast. At this time, all participants are in a listen-only mode. Later, we'll 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.

Thank you. Good morning, and thank you for joining our conference call to discuss Amicus Therapeutics second 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 Costelli, Chief Development Officer, and Simon Harford, Chief Financial Officer. Joining for Q&A is Dr. Mitchell Goleman, Chief Medical Officer, and Ellen Rosenberg, Chief Legal Officer. As referenced on slide two, we may make forward-looking statements within this meeting of the Private Security Litigation Reform Act of 1995 relating to our business as well as our plans and prospects. Our forward-looking statements should not be regarded as 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 dates hereof. 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 dates hereof. For a full discussion of such forward-looking statements and the risks and uncertainties that may impact them, we refer you to the forward-looking statements and risk factor sections of 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 June 30th, 2024, to be filed with the Securities and Exchange Commission today. At this time, it's 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 2024 conference call. I'm pleased to highlight what has been a very successful first half of the year across our global business and particularly an incredible quarter. In this time, we have continued to build on our top line revenue growth momentum to put 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 highlight several key points. First, we continued our excellent commercial execution and delivered total revenue of 127 million in the quarter, representing 34% 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 26 to 31% from 25 to 30% previously. At the product level, Gallifold continues its strong performance with $111 million in global revenue in the quarter, which represents 19% growth from last year on a constant currency basis. In the first half of the year, operational growth was 17% year-over-year at constant exchange rates, coming in at the high end of our guidance for the year. We continued to observe strong trends across our key performance indicators and all key geographies in the second quarter, including continued demand through new patient starts, both from switch and naive populations in all of our leading markets, and sustained patient compliance and adherence rates of over 90%. All of this is against the backdrop of significant growth in diagnosed and treated patients that we've highlighted previously. Eight years now after our first commercial launch, it's remarkable to see what an impact this medicine is having on people living with Fabry disease around the world. And we continue to see Gallifold serving as the foundation of our business for the next decade and beyond. Based on the sustained performance, we are increasing our full-year 2024 revenue growth guidance range for the second time. We started the year with a growth range of 11% to 16%. In May, we raised it to 13% to 17%, and now we're projecting 14% to 18%. Second, let me highlight the continued strong global commercial launch of Pompility and Outfolda, our novel therapy for late-onset Pompe disease. Pompility and Upholda has been and will continue to be a huge growth driver for us this year. We've already made great progress against our key performance indicators, which continue to demonstrate the strength of this launch. First and foremost, our number one focus for the year is to maximize the number of patients on therapy by year end. It's great to report that the rate of new commercial patients coming on Pompility and Upholda in 2024 continues to progress exceptionally well. In the second quarter, we saw the largest number of new commercial patients meaning patients who were not in our clinical studies. And as of the end of July, we had 186 patients who had been treated or scheduled for treatment. We are incredibly pleased with the demand globally from patients and physicians of this new therapy and consistently hear inspiring anecdotes from healthcare professionals around the world on how their patients are responding to Pondability and Upholda, which will continue to fuel the momentum throughout the year and beyond. Sebastian will provide more details in a moment, but the switch dynamics in the U.S., Europe, and the U.K. continue to look strong, and we're seeing great uptake in naive patients and markets outside the U.S. as well. We're also making significant progress on reimbursement front globally, and this includes moving patients more quickly through the insurance process in the U.S. as we've anticipated. Throughout the remainder of the year, we'll focus on increasing patient access as we gain reimbursement and launch in additional countries throughout Europe. On the regulatory front, we're pleased to announce that in July, the Swiss Medic approved Pompility and Upholda for adults living with late-onset Pompe disease in Switzerland. For the full year 2024, we're well on track to deliver our guidance of $62 to $57 million in global Pompility and Upholda sales, which will be a significant contributor to our growth and set us on a great course to achieve our ambition for POMOP to become the new standard of care treatment in this devastating disease. We're incredibly pleased to be providing a real choice for patients and challenging therapeutic expectations for both physicians and people living with Pompe disease. And finally, as we continue our excellent commercial execution across both therapies and prudently manage our resources, we are excited to share that Amicus was profitable on a non-GAAP basis in the second quarter, as well as the first half of the year. We are confident we'll see this number increase as we look to achieve our full year non-GAAP profitability in 2024. Ahead on slide four, as we laid out at the beginning of the year, we're focused on achieving our four key strategic priorities for 2024, including first, sustaining double-digit Gallifold revenue growth. And again, on the back of strong sales growth so far, we've raised the expected annual growth rate of Gallifold to 14% to 18%. Successfully executing on multiple commercial launches of Pompility and Opfolda, advancing our ongoing studies to support our medical and scientific leadership in Fabry and Pompe disease, and maintaining a strong financial position as we carefully manage our expenses and investments to achieve non-GAAP profitability for the full year. With that highlight, let me now hand the call over to Sebastian, who'll go through our commercial performance in more detail. Sebastian?