Amicus Therapeutics, Inc.

Good morning, ladies and gentlemen, and welcome to the Amicus Therapeutics Third 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 for joining our conference call to discuss Amicus Therapeutics' third quarter 2023 financial results and corporate highlights. Leading today's call, we have Bradley Campbell, President and Chief Executive Officer, Sebastian Martel, Chief Business Officer, Simon Harford, Chief Financial Officer, and Dr. Jeff Costelli, Chief Development Officer. Joining for Q&A is Dr. Mitchell Goleman, Chief Medical Officer, Ellen Rosenberg, Chief Legal Officer, and Mike Cavaney, President of U.S. Commercial Business and Head of Global Marketing, As referenced on slide two, we may 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 of our 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. We would caution 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 for the year ended December 31st, 2022, and the quarterly report on Form 10-Q for the quarter ended September 30th, 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 third quarter 2023 conference call. I'm very pleased to highlight the continued progress across our global business through what has been a tremendous third quarter for Amicus. As we did in this morning's press release, let me highlight several key points before I turn it over to the team to give more detail. First, Gallifold continues its strong performance and remains the cornerstone of our success. We are very pleased with the commercial uptake of Gallifold globally, which for the first time has achieved over $100 million in quarterly revenue. Gallifold's performance represents 19% growth from the third quarter last year on a constant currency basis, And on a year-to-date basis, Gallifold revenue growth was 17%, both at constant exchange rates as well as in reported numbers. We continue to observe strong trends across our key performance indicators in all key geographies in the third quarter. This includes continued demand through new patient starts from both the switch and naive populations in all of our leading markets, a steady growth of in-person visits between our field team and Fabry treaters over the same period last year, and sustained patient compliance and adherence rates of over 90%. Growth in the third quarter was driven primarily by patient demand from net new patient starts. Based on Gallifold's strong performance throughout the first nine months, we are increasing again our full year 2023 revenue growth guidance to 16% to 18% at constant exchange rates. Second, Pompility and Opfolda, our novel therapy for late-onset Pompe disease, is now approved and launched in the three largest Pompe markets. Following the recent US FDA approval of Pompility and Opfolda in September, the commercial launch is now well underway in Germany, the UK, and the US, which again are the three largest Pompe markets globally. As Sebastian will cover in more detail in a moment, our team is making tremendous progress in converting individuals from clinical studies and expanded access programs to commercial supply in our reimbursed geographies. We're also already seeing new commercial patients who are switching from both of the available ERTs, and additionally in Europe, patients naive to treatment coming on to commercial drug as well. We're pleased to share that as of early November, more than 60 patients are being treated with commercial product, and multiple additional patients have been scheduled to start their treatments. We're very pleased to see the early days of the launch track ahead of our expectations, And importantly, we're well on track towards our goal of transitioning all clinical trial patients to commercial supply in these three major markets by year end. Beyond that, we'll continue to focus on the broader patient access by expanding into the major European markets as we navigate the country-by-country reimbursement process and focus on additional regulatory submissions outside of Europe as well. By the end of this year, we will have submitted reimbursement dossiers in over a dozen countries With the global launch of Pompility and Upholda, we look forward to providing a real choice to challenging therapeutic expectations for both physicians and those living with Pompe disease. Finally, we've continued to maintain a strong financial position as we execute on the expansion of Gallifold and advance the global launch of Pompility and Upholda. With the launch now well underway, the recent refinancing of our debt under more favorable terms and continued strong growth from Gallifold, we are well on track to achieve non-GAAP profitability in the fourth quarter this year. Ahead on slide four, we're also making great progress towards achieving our key strategic priorities for 2023. First and foremost, continuing to sustain double-digit growth for Gallifold around the world. On the back of our strong performance year to date, we have now raised the expected annual growth rate of Gallifold to 16 to 18% at constant exchange rates, We've now secured regulatory approvals for Pompility.FoldUp by the FDA, EMA, and NHRA, and now are executing successful launches in those key markets. We've continued to judiciously invest in the advancement of our best-in-class next-generation Fabry and Ponte genetic medicines and capabilities, as well as our next-generation chaperone for Fabry disease. And as always, we are maintaining a strong financial position as we carefully manage our expenses. and investments and continue to grow the top line on our path to non-GAAP profitability. With that, let me now hand the call over to Sebastian Martel, our Chief Business Officer, to further highlight our commercial performance. Sebastian?