Amicus Therapeutics, Inc.

Good morning, ladies and gentlemen, and welcome to the Amicus Therapeutics First 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 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.

Thank you, Jill. Good morning. Thank you for joining our conference call to discuss Amicus Therapeutics' first 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 Goldman, Chief Medical Officer, and Ellen Rosenberg, Chief Legal Officer. As referenced on slide two, we might make forward-looking statements within the meaning of the Private Security Litigation Reform Act 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 date 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 date 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 factors section of our annual report on Form 10-K, The year ended December 31st, 2023, and the quarterly report on Form 10-Q for the quarter ended March 31st, 2024, to be filed to 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 first quarter 2024 conference call. I'm pleased to report a strong start to the year across our global business. We continue to build on the momentum of significant top line revenue growth on our way to our first full year of non-GAAP profitability, while advancing our mission of bringing hope to patients and families affected by rare diseases. As we did in this morning's press release, let me just highlight several key points before I turn it over to the team to go to more detail. First, we continued our excellent commercial execution and delivered strong total revenue of $110 million, representing 28% growth year over year. GalaFold continues its strong performance, and we remain very pleased with the continued commercial uptake globally. For the first quarter, GalaFold revenue was $99 million globally, representing 16% growth year over year on a constant currency basis, coming in at the high end of our initial guidance for the year. For GalaFold, we continue to observe strong trends across our key performance indicators and all key geographies in the first quarter. including continued demand through new patient starts from both the switch and naive populations in all of our leading markets, and sustained patient compliance and adherence rates of over 90%. All of this is across the backdrop of the significant growth in the diagnosed and treated patients that we've highlighted previously. We see Gallifold serving as the foundation of our business for the next decade and more. Based on Gallifold's strong performance in the first year, we are pleased to be raising our full year 2024 revenue growth guidance from 11% to 16% to now 13% to 17%. Second, let me highlight the strong global commercial launch of Pompility and Opfolda, our novel two-component therapy for late-onset Pompe disease, now launched in Germany, Austria, the UK, the US, and also now in Spain. POMOP, as we like to call it, is a huge driver of growth for us this year. And our progress against our key performance indicators that we've shared previously continues to demonstrate the strength of this launch. Our number one focus for this year is to maximize the number of patients on therapy by year end. And in light of that, it's great to report that the rate of new commercial patients coming on to PalmOp in 2024 is double that of last year. In fact, for the month of April, we saw the largest number of new commercial patients start on PalmBility and OpFolda since our launch. And as of the end of last month, we had 155 patients on treatment or scheduled for treatment. We're incredibly pleased with the patient and physician demand for this new therapy globally and continue to hear inspiring anecdotes from treaters around the world on how their patients are responding to Pombility and Epfolda, which will help continue to build 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 U.K. also continue to look strong, and we're seeing great progress on the reimbursement front globally, including moving patients more quickly through the insurance process in the U.S. as we anticipated we would. We've also just launched in Spain and are off to a great start there. And throughout the remainder of 2024, we'll focus on increasing patient access as we gain reimbursement and then launch in additional countries throughout Europe. Before I turn it over to the team, let me also comment on the new guidance we're providing. As we set upon approval and coming into this year, we needed about six to 12 months of trends before we had enough information to provide revenue guidance. Now with more than six months since launch in the three largest Pompei markets and the great trends we're seeing, we feel we now have enough information to accurately forecast our performance for the year. You'll see in the press release and in the slides For the first time, we've announced that we expect to deliver $62 to $67 million in global sales, which will again be a significant contributor to our growth and set us on a great course to achieve our ambition for Pompility and Upholda to become the new standard of care in treating this devastating disease. We are incredibly pleased to be providing a real choice for patients and physicians and challenging therapeutic expectations for people living with Pompe disease. Finally, as we continue our excellent commercial execution across both therapies and prudently manage our resources, we are confident we are well on track to achieve full-year non-GAAP profitability in 2024. Ahead on slide four, as we lay out the beginning of the year, we continue to focus on delivering against our three, excuse me, our four key strategic priorities, including sustaining double-digit Gallifold revenue growth, On the back of strong sales, again, we've raised that expected annual growth rate of Gallifold to 13% to 17% to account for the exchange rates, successfully executing on multiple commercial launches of Pompility and Upholda, advancing our ongoing studies to support our medical and scientific leadership in Fabra and Pompe disease, and maintaining our strong financial position as we carefully manage our expenses and investments to achieve non-gap profitability for the full year. With that overview, let me now hand the call over to Sebastian to further highlight our commercial performance. Sebastian?