Amicus Therapeutics, Inc.

Good morning, ladies and gentlemen, and welcome to the Amicus Therapeutics first quarter 2023 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.

Good morning. Thank you, Gigi. Thank you for joining our conference call to discuss Amicus Therapeutics' first quarter 2023 financial results and corporate highlights. Leading today's call, we have Bradley Campbell, President and Chief Executive Officer, Daphne Queeney, Chief Financial Officer, Sebastian Martel, Chief Business Officer, and Dr. Jeff Castelli, Chief Development Officer. Joining for Q&A is Dr. Mitchell Volman, Chief Medical Officer, and Alan Rosenberg, Chief Legal Officer. As referenced on slide two, we might make forward-looking statements within the meaning of the Private Securities 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 date hereof. All forward-looking statements are qualified in their entirety by this questionnaire 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, for the year ended December 31st, 2022, and the quarterly report on Form 10-Q for the quarter ended March 31st, 2023, to be filed later today with the Securities and Exchange Commission. 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 2023 conference call. I'm pleased to report a successful start to the year across our global business, As we did in this morning's press release, let me highlight several key points before I turn it over to the team to provide more detail. First, Gallifold continues its strong performance and remains the cornerstone of our success. We continue to be very pleased with the commercial uptake of Gallifold globally, with $86 million in first quarter revenue representing 14% growth from the first quarter last year on a constant currency basis. Strong trends continue across a number of our key performance indicators, including increasing demand through new patient starts for both switch and naive populations, steady growth of in-person visits between our field team and Fabry treaters, and sustained patient compliance and adherence rates of over 90%. We expect to see continued double-digit growth in 2023, fueled by significant demand for patients and physicians. And in fact, as Sebastian will highlight in a moment, This was the best first quarter performance for net new patient starts in the past four years. Second, we continue to make great progress on our global regulatory filings and commercial planning for ACGA, our novel two-component therapy for Pompe disease. Importantly, I'm very happy to report that the US FDA has recently completed the required pre-approval inspection of the Wuxi Biologics manufacturing site in China. We're very pleased with the outcome of the inspection and believe the comments and observations received by Wuxi at the close of the inspection are all addressable. We therefore continue to expect regulatory approval of ACGA in the United States in the third quarter of 2023. I'd also like to give a word of thanks to the FDA inspectors, the Wuxi team, and the Amicus team the collaborative and professional conduct leading up to and during the course of the inspection. The regulatory reviews in Europe and the UK also remain on track. In March, the European Commission granted approval of Opfolda for the use in combination with Opfolda for adults with late onset Pompe disease. And as we just announced, the CHMP also adopted a positive opinion recommending marketing authorization of Opfolda So we continue to anticipate the full approval of Pombility plus Afolda to occur in the third quarter this year. And upon approval, this will be the first two-component therapy available in the European Union for the treatment of adults living with late-onset Pompe disease. And finally, the UK regulatory process for APGA was initiated December of last year and is following a similar timeline as the US and Europe, with expected approval in the third quarter this year as well. As we've observed throughout 2022, we remain extremely pleased with the level of interest and participation we're seeing in our expanded access mechanisms for APGA globally. As we get through the first part of 2023 across all of our ongoing clinical studies and expanded access programs, there are now approximately 200 patients on APGA, which we believe represents more than 5% of the total treated Pompe patients around the world. And we have more patients in the queue, so we expect this number to continue to trickle upward as we approach launch. In anticipation of the regulatory approvals, our global launch planning progress continues as we eagerly anticipate the final approvals of ATGA. We very much look forward to providing a real choice in this therapeutic area, both in the United States and in Europe, with regulatory applications in additional countries planned in the months ahead. And third, Amicus has maintained a strong financial position as we continue to execute on the global expansion of Gallifold and prepare for the global launch of ATGA. Importantly, Based on the latest assumptions on approvals and launch of APGA, our current operating plan, and continued careful management of expenses, we remain on track to achieve non-GAAP profitability, which we expect in the second half this year. And on slide four, as we laid out at the beginning of the year, we are laser-focused on achieving our key strategic priorities for 2023, including, number one, sustaining that double-digit growth revenue of 12% to 17% for Gallifold at constant exchange rates, delivering this important medicine to more people living with Fabry disease with amenable variants and existing in new markets. Second, securing regulatory approvals of ATGA by the FDA, EMA, and NHRA this year, as well as continuing to advance preparations for the anticipated launches. Number three, continue to judiciously invest in the advancement of our best-in-class next-generation Fabry and Pompe genetic medicines and capabilities, as well as our next-generation chaperone for Fabry disease Number four, as always, maintaining a strong financial position as we carefully manage our expenses and investments on our path to non-GAAP profitability. With that overview, let me now turn the call over to Sebastian Martel, our Chief Business Officer, to further highlight the Gallifold performance. Sebastian?