Amicus Therapeutics, Inc.

Good morning, ladies and gentlemen, and welcome to the Amicus Therapeutics second quarter 2023 financial results conference call-in 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 Fonin, Vice President of Investor Relations. You may begin.

Thank you, Tana. Good morning. Good morning. Thank you for joining our conference call to discuss Amicus Therapeutics second quarter 2023 financial results and corporate highlights. Leading today's call, we have Bradley Campbell, President and Chief Executive Officer, Daphne Creamy, Chief Financial Officer, Sebastian Martel, Chief Business Officer, and Dr. Jeff Costelli, Chief Development Officer. Joining for Q&A is Dr. Mitchell Goldman, Chief Medical Officer, and Ellen Rosenberg, Chief Legal Officer. 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 would 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. We 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 for the year ended December 31st, 2022, and the quarterly report on Form 10-Q for the quarter ended June 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 everybody to our second quarter 2023 conference call. I'm very pleased to highlight what has been an incredibly successful first half of the year across our global business. As we did in this morning's press release, let me highlight several key points. First, Gallifold continues its strong performance and remains the cornerstone of our success. We remain very pleased with the commercial uptake of Gallifold globally, with $180 million in revenue for the first half of 2023. This represents 16% growth from last year on a constant currency basis, and the second quarter operational growth was 17% year over year at constant exchange rates. We continue to observe strong trends across our key performance indicators in all key geographies in the second quarter. This includes increasing demand through new patient starts from both the switch and naive populations, steady growth of in-person visits between our field team and Fabrate treaters around the world, and sustained patient compliance and adherence rates of over 90%. Growth in the second quarter was driven primarily by patient demand, and as Sebastian will highlight in a moment, we saw new patients starting on Gallifold globally throughout the second quarter at rates we haven't seen since the first few years of launch. Based on Gallifold's strong first half performance, We're pleased to be raising our full year 2023 revenue growth guidance range to 14 to 18% at constant change rates. Second, we continue to make great progress on our global regulatory filings and have now commenced the commercial launch for Pompbility and Opfolda, our novel two-component therapy for Pompe disease. Following the EC approval of Opfolda in June, the commercial launch is well underway in Germany. Our team is in the process of switching over individuals from clinical studies and expanded access programs to commercial supply. And we're pleased to share that the first patients have now been dosed with commercial products, with multiple additional patients having been scheduled to start their infusion in the coming days and weeks. Importantly, we're well on track to transition to 20 clinical trial and expanded access patients within our 90-day target. Outside of Germany, we're focused on broader patient access across Europe as we navigate the country-by-country pricing and reimbursing process. In the U.S., we've been pleased to see an increased level of engagement from the agency in recent weeks and are confident now we're on track for an FDA approval in Q3. And finally, the U.K. regulatory process for APGA was initiated in December of last year, and we have just received word this morning that the MHRA has approved Opfolda. As a reminder, MHRA previously approved Pombility and both have received orphan designation. We now expect the NICE final assessment document to come in the next few days, at which point it will take about 30 days for the NHS to provide funding to local centers to begin commercial infusions. With our international launch commenced and poised for regulatory approval in the US and additional key markets on the horizon, we look forward to providing a real choice and challenging therapeutic expectations for both physicians and the people living with Pompe disease around the world. Finally, Anikus has maintained a strong financial position as we continue to execute on the global expansion of Galfold and begin the global launch of Pompbility and Upholda. Importantly, based on the latest assumptions on approvals and launch of Pompbility and Upholda, combined with the strong growth we've seen in Galfold in the first half of the year, we are on track to achieve our target of non-GAAP profitability in the second half this year. Ahead on slide four, we're making great progress across our key strategic priorities for 2023, including sustaining double-digit Gallifold growth, now at an anticipated growth rate of 14% to 18% at constant exchange rates, securing regulatory approvals of ATGA by the FDA, EMA, and MHRA, and executing successful launches in those key markets. continuing to judiciously invest in the advancement of our best-in-class next-generation Fabre and Pompe genetic medicines and capabilities, as well as our next-generation chaperone for Fabre disease, and 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 hand the call over to Sebastian Martel, our Chief Business Officer, to further highlight our commercial performance.