Amicus Therapeutics, Inc.

Good morning, ladies and gentlemen, and welcome to the Amicus Therapeutics second 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, and instructions will follow at that time. Should anyone require assistance during the conference, please press star then zero on your touchtone telephone. As a reminder, this call is being recorded. I would now like to turn the conference over to your host, Mr. Andrew Fonning. Executive Director of Investor Relations. Please go ahead.

Thank you, Cole. Good morning. Thank you for joining our conference call to discuss Amicus Therapeutics' second quarter 2022 financial results and corporate highlights. Leading today's call, we have Bradley Campbell, President and Chief Executive Officer, Daphne Queamy, Chief Financial Officer, Sebastian Martel, Chief Business Officer, and Dr. Jeff Costelli, Chief Development Officer. Joining for Q&A is Dr. Mitchell Goldman. 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 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 and on our quarterly report Form 10-Q for the quarter-ended June 30, 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 Bradley Campbell, President and Chief Executive Officer.

Brad? Great. Thank you, Andrew, and welcome, everyone, to our second quarter 2022 results conference call. Before we dive into the results of the quarter, I'd just like to start with a deep thank you to John Crowley. As planned after 17 great years leading Amicus as our founding CEO, John has officially assumed the role of executive chairman of Amicus for a two-year term, after which he is expected to continue as the non-executive chairman of the board. It has been an honor working alongside him for 16 of those years, and it's been through his leadership and unwavering commitment to all of those living with rare diseases that Amicus is in such a great position today. I'm honored now to assume the role of president and CEO and very excited about the opportunities that lie ahead. Amicus has strong business fundamentals and a positive momentum to build on. We are poised now for the next chapter of our growth as we seek to get our second medicine approved and launched around the world. I firmly believe that we have the right people and the right assets to deliver on our mission to continue to bring great medicines to people living with rare diseases and create great value for our shareholders. Building on our commitment to patients, leadership of rare diseases, and global operating platform, I am confident that we can achieve those two objectives. With that, let me get started on today's update. I'm pleased to highlight the successful first half of the year across our business. And as we did in this morning's press release, let me highlight several key accomplishments. First, Gallifold continues its strong performance and remains the cornerstone of our success. We continue to be very pleased with the uptake of Gallifold globally, despite the significant foreign currency headwinds that spaced our industry this year. The first half of the year represented 11% reported revenue growth or 18% in an operational revenue growth basis. In the second quarter, operationally, our growth and key performance indicators are meeting or exceeding our objectives in all key geographies, and we are reiterating our guidance at constant exchange rates. Sebastian Martel, our Chief Business Officer, will provide further detail later in the call. We are also excited to announce that the Gallifold Intellectual Property Estate continues to grow this quarter. This year alone, we have strengthened our IP estate through the issuance of 17 new patents. There are now 44 Orange Book-listed issued patents related to Gallifold in the United States, 28 of which provide protection to 2038 and beyond, and importantly include three newly issued composition of matter patents, bringing the total now to four. We see this patent portfolio, along with our orphan drug exclusivities, providing broad and long-term intellectual property rights well into the late 2030s for this novel precision medicine. And importantly, we believe we are well positioned to address any potential generic challenges to our patents. Looking ahead, we expect continued growth for Gallifold this year, and with this strengthened IT protection, continue to believe it has a long runway well into the next decade. Second, we continue to make progress on our global regulatory filings for APGAA, our novel next-generation therapy for Pompe disease. The US and EU regulatory reviews are progressing very well, and we're very pleased with the level of engagement from both regulatory agencies. Clearly, all eyes are on the FDA inspection at the Wuxi Biologics Facility for APB200, the biologic component of APGAA. We remain in active dialogue with the agency on how best to support an inspection, and we, along with our colleagues at Wuxi, are fully ready to welcome FDA inspectors to the Wuxi facility in China. However, as of today, they have not yet conducted their inspection, If the FDA inspection does not take place in the appropriate time, it goes without saying that it could impact the timing of approval. That being said, the good news is we are in late-stage label discussions and are highly confident in ATGA's potential approval in the United States. And at this time, we continue to expect that the two components of ATGA will be approved together by the October 29th action date. Importantly, in Europe, we're now actively engaged with the EMA on the marketing authorization applications for ATGA We continue to expect a positive CHMP opinion later this year and commercial launch at early 2023. And as a reminder, the EMA has indicated it does not require an inspection of the WUSHI manufacturing site as a condition of their approval. I'm also extremely pleased today with the level of interest we are seeing in our expanded access programs globally. Today, we announced the first reimbursed access to ATGA has been granted in France under their Compassionate Access Program, which was formerly known as the Nonative ATU Program. Additional access programs are in place in the United States, United Kingdom, Germany, and Japan, with a growing number of patients participating in each. Across all of our ongoing clinical studies and access programs, there are now more than 175 patients on ATGA today, which we believe represents 5% or more of the total treated Pompe patients around the world. Our global launch plans continue to move ahead, including pre-launch activities, targeted investments, and additional personnel to support the launch significant investments in the launch and inventory preparations. We are now closer to having another potential treatment option for patients living with Pompe disease, both in the United States and Europe, with further regulatory applications planned in the months ahead. And third, importantly, Anikis has maintained a strong financial position and remains committed to achieving profitability in 2023, as we continue to execute on the global expansion of Galfold and prepare for the global launch of ATGA. we are rapidly approaching two pivotal inflection points for amicus. First, the global launch of a second rare disease medicine with ATGAA, and second, achieving profitability. These are rare feats that we believe will enable amicus to truly enter the upper echelon of rare disease-focused biotechnology companies. I'll emphasize that we are sharply focused on three key objectives, continuing to advance GalaFold to as many patients in as many geographies as possible, securing approvals for and launching APGA globally, and ensuring the financial strength of Amicus. On slide five, we see we're well on our way now towards achieving our key strategic priorities for this year, including continuing to drive Gallifold to more people living with Fabray with amenable variants in existing and in new markets. We look to achieve double-digit global product revenue growth at 15 to 20% with revenue of $350 million to $365 million in constant exchange rates. This reflects the strong momentum and demand behind this precision medicine globally. We remain steadfast in our commitment to advancing APGA regulatory filings and initiating the anticipated launch of APGA in the United States. Leveraging our seasoned global commercial team and experience across all areas needed for an effective drug launch, we are fully prepared and anticipate a very successful launch for APGA. We are strategically advancing our best in class next generation genetic medicines and capabilities. And again, we will continue to maintain a strong financial position as we carefully manage our expenses and investments going forward. With that overview, let me now hand the call over to Sebastian Martel, our Chief Business Officer, who can further highlight the Gallifold performance. Sebastian?