Amicus Therapeutics, Inc.

Good morning, ladies and gentlemen, and welcome to the Amicus Therapeutics First Quarter 2022 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. An instruction will follow at that time. If anyone should require assistance during the conference, please press star and then zero on your touchtone telephone. As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Mr. Andrew Fonin, Executive Director of Investor Relations. You may begin.

Thank you, Charlotte. Good morning, everyone. Thank you for joining our conference call today to discuss Amicus Therapeutics' first quarter 2022 financial results and corporate highlights. Speaking on today's call, we have John Crowley, Chairman and Chief Executive Officer, Bradley Campbell, President and Chief Operating Officer, Daphne Queamy, Chief Financial Officer, and Dr. Jeff Costelli, Chief Development Officer. Joining for Q&A will have Dr. Mitchell Coleman, Chief Medical Officer, and Sebastian Martel, Chief Business 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 plans will be achieved. Any or all of 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 our Form 10-K for the year-ended 2021 and for the quarter-ended March 31, 2022, to be filed later today with the Securities and Exchange Commission. At this time, it is my pleasure to turn the call over to John Crowley, Chairman and Chief Executive Officer. John?

Great. Thank you, Andrew, and welcome, everyone, to our first quarter 2022 results conference call. I'm pleased to highlight the successful start to the year across our business and reiterate the amicus team's focus on our business priorities, despite, as we all know, this tumultuous stock market environment across the biotech sector. Let me begin by emphasizing that we are sharply focused on three primary objectives. One, continue to advance Gallifold to as many patients in as many geographies as possible. Two, secure approvals for and launch ATGAA and Pompe disease globally. Three, ensure the financial strength of amicus, including the path to profitability without the need for any further equity-based financing. As we did in this morning's press release, let me elaborate on several key accomplishments. First, Gellifold continues its strong performance and remains the cornerstone of our success. With $78.7 million in first quarter revenue, a nearly 19% increase from a year ago, we continue to be very pleased with the uptake of Gallifold globally. Its growth thus far this year is meeting or exceeding our objectives in all key geographies. We are excited to announce also that the intellectual property portfolio estate for Gallifold has been strengthened by the issuance of eight new patents this year. Together, there are now 35 Orange Book listed issued patents related to Gallifold in the United States, which provide protection through 2038, including the very important and recently issued composition of matter patent. This portfolio will provide broad and long-term intellectual property rights well into the late 2030s for this novel precision medicine. We expect significant growth for Gallifold in 2022, And with this strengthened IP protection, believe that it has a long runway into the next decade and beyond, and that Gallipold continues to have the potential to achieve $1 billion in peak revenue. Second, we continue to make great progress on our global regulatory filings for ATGAA, our novel next-generation therapy for Pompe disease. The U.S. and EU regulatory reviews are progressing very well, and we are extremely pleased with the level of engagement from the regulatory agencies. We now have recently completed the late cycle review with the U.S. FDA and are now in labeling discussions with the agency. We remain confident in ATGAA's approvability and its potential to become the next standard of care in Pompe disease. We continue to expect a manufacturing inspection at the WUSHI facility for the biologic ATB200 again, the biologic component of ATGAA, and that this will be needed for FDA approval. We are carefully watching the COVID-19 situation in China and recognize that it could impact the potential timing of an inspection. We are in communication with the agency regarding the best way to support an inspection. Amicus also continues to evaluate all options with respect to the inspection requirement. We and our partners at WUSHI have completed all preparatory work, including internal mock inspections, and are fully prepared. Today, we continue to expect the agency to approve the applications together by the July 29 action date. In the EU, we are actively engaged with the EMA on the Marketing Authorization Applications, or MAA, for ATGAA. We continue to expect a positive CHMP opinion later this year and commercial launch in 2023. Of note, importantly, the EMA has indicated that it will not require a new inspection of the WUSHI manufacturing site. Our global launch plans continue to accelerate, including pre-launch activities, targeted investments in additional personnel to support the launch, and significant investments in launch inventory preparations. We are now closer to having another potential treatment option for people living with Pompe disease, both in the United States and in Europe, with further regulatory applications planned in the months ahead. Of note also, both the EMA and the US FDA have approved the trade names for this novel new treatment paradigm for people living with Pompe. So we expect one global brand name, which of course we will not disclose until approval. And third, and importantly, Amicus has maintained a strong financial position and remains committed to achieving profitability in 2023 as we continue to execute on the global expansion of Gallifold and prepare for the global launch of ATGAA. We have no need for any equity or equity-linked financings to achieve profitability. In order to accomplish this, we will concentrate the vast majority of our efforts and investments in our priority growth franchises Infebre disease, and Pompe disease. And we'll do this through the continued global growth and commercialization of GalaFold, through advancing the activities to secure global regulatory approvals and commercial launch for ATGAA, and by making judicious strategic investments in next-generation therapies Infebre and Pompe and in core science and platform technologies in the field of genetic medicine. We are rapidly approaching two pivotal inflection points for amicus. First, the global launch of a second rare disease medicine with ATGAA. And secondly, profitability. These are feats that we believe will enable amicus to truly enter the upper echelon of biotechnology companies. Ahead on slide six, and as we laid out last month, we are focused on achieving our key strategic priorities for the year. These include One, we will continue to drive Gallifold to more people living with Febre disease with a minimal variance in existing and new markets. We look to achieve double-digit global product revenue growth of 15 to 20 percent with revenue of $350 million to $365 million at constant exchange rates. This reflects the strong momentum and demand behind this precision medicine globally. Second, we remain steadfast in our commitment to advancing ATGAA regulatory filings and initiating the anticipated launch of ATGAA in the United States. Leveraging our seasoned global commercial team and experience across all areas for an effective drug launch, we are fully prepared and anticipate a successful launch of ATGAA. Third, we are strategically advancing our best-in-class next-generation genetic medicines and capabilities. And finally, again, we continue to maintain a strong financial position, as we carefully manage our expenses and investments, and we remain fully funded through all major milestones. With that introduction, let me go ahead now and turn the call over to Bradley Campbell, our President and Chief Operating Officer, to further highlight the Gallifold performance. Bradley.