Amylyx Pharmaceuticals, Inc.

Good afternoon. My name is Chuck, and I will be your conference operator for today. At this time, I would like to welcome everyone to the Amilex Pharmaceuticals Third Quarter 2022 Earnings Conference Call. All participants will be in a listen-only mode. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then 1 on your telephone keypad. And to withdraw your question, please press star then 2. Please be advised that this call is being recorded at the company's request I would now like to turn the conference over to Ms. Lindsay Allen, Head of Investor Relations and Communications. Please go ahead, ma'am.

Good afternoon, and thank you for joining us today to discuss our third quarter 2022 earnings. With me on the call are Josh Cohen and Justin Klee, our co-CEOs, Margaret Olinger, our Chief Commercial Officer, and Jim Friedes, our Chief Financial Officer. Before we begin, I would like to remind everyone that any statements we make or information presented on this call that are not historical facts are forward-looking statements that are based on our current beliefs, plans, and expectations and are made pertinent to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements made during this call include our expectations for the commercialization of and the timing of receipt of revenue from Relivrio and Albreoza, statements regarding regulatory developments, the anticipated timing of coverage and policy decisions by insurance plans related to Relivrio and whether those decisions will be favorable, expectations regarding access to and coverage, our expectations with respect to recruitment and completion of our ongoing Phoenix trial, and the anticipated ramp in our SG&A expenses. Actual events and results could differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties, and other factors, including those set forth in our most recent filings with the SEC and any other future filings that we may make with the SEC. You are cautioned not to place any undue reliance on these forward-looking statements. And Amilex disclaims any obligation to update such statements. Now, I will turn the call over to Justin.

Thank you, Lindsay. And thank you, everyone, for joining the call. Our mission is to end the suffering caused by neurodegenerative diseases. And while much work remains, the past few months have marked incredible progress. including the FDA approval and commercial launch of Relivrio for adults living with ALS in the United States. This marks our second commercial launch following the approval of Albreoza with conditions in Canada. We know the ALS community is counting on us, and we are working every day to help ensure that every eligible person who can benefit from Relivrio and Albreoza can gain access as quickly and efficiently as possible. Given we are only a few weeks into the launch in the U.S., it is too early to discuss specific expectations, but we are encouraged by the initial engagement with both physicians and with people living with ALS. Margaret will share some further insights shortly. Aside of North America, we are actively pursuing regulatory approval of AMX 35 for the treatment of ALS in the European Union. Our marketing authorization application remains under review by the Committee for Medicinal Products for Human Use, or CHMP, of the EMA. We are now in possession of the Rapporteur's Day 150 Joint Assessment Report, which is provided to applicants as a reference as the CHMP collects comments to responses made to the Day 120 list of questions. While we have resolved several major objections from the Day 120 list of questions, some still remain. and we will work to continue to try to address them as part of the MAA review process. The next step in the process is the day 180 list of outstanding issues, which we will respond to accordingly. The CHMP also intends to hold a scientific advisory group meeting as part of the regulatory review process. The EMA process is still on track, and we expect a decision in the first half of next year. With that, I'll turn the call over to Margaret to share some insights into the early days of our launch in the United States and to provide an update on our Canadian launch.