Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) Q1 2023 Earnings Conference Call May 11, 2023 6:00 PM ET

Company Participants

Lindsey Allen - Head of Investor Relations and Communications

Justin Klee - Co-Chief Executive Officer and Co-Founder

Margaret Olinger - Global Head of Commercial and CCO

James Frates - Chief Financial Officer

Josh Cohen - Co-Chief Executive Officer and Co-Founder

Conference Call Participants

Corinne Jenkins - Goldman Sachs

Marc Goodman - SVB Securities

Ananda Ghosh - H.C. Wainwright

Neena Bitritto-Garg - Citi

Lindsey Allen

Good afternoon and thank you for joining today to discuss our First Quarter 2023 Earnings. With me on the call are Josh Cohen and Justin Klee, our Co-CEOs; Margaret Olinger, our Chief Commercial Officer; and Jim Frates, 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. These statements include, but are not limited to our expectations with respect to RELYVRIO and ALBRIOZA, statements regarding regulatory developments and the expected timing thereof, our business strategy and outlook and our expected financial performance.

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 Amylyx disclaims any obligation to update such statements unless required by law.

Now, I will turn the call over to Justin.

Justin Klee

Thank you, Lindsey, and good afternoon. As everyone on this call knows, there's an enormous unmet need in ALS and other relentlessly progressive and fatal neurodegenerative diseases. It is our mission at Amylyx to one day and the suffering caused by these diseases. Our treatment delivery enabled us to make meaningful advances toward and continued investment in our mission. During the first quarter, we generated 71.4 million in net product revenues. Reflecting the significant progress we continue to make toward our goal of ensuring every eligible person living with ALS has access to RELYVRIO. RELYVRIO is the first and only approved treatment for ALS set in a randomized placebo controlled trial. Both met its pre-specified primary outcome demonstrating a statistically significant benefit and function and showed a benefit on survival and a longer term post hoc analysis. These data suggests that ALS can in fact be treated.