Amylyx Pharmaceuticals, Inc.

Good morning. My name is Keith, and I will be your conference operator today. At this time, I would like to welcome everyone to the Amelix Pharmaceuticals Third Quarter 2023 Earnings Conference Call. All participants will be in 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. To withdraw your question, please press star, then 2. Please limit yourself to questions 1 and a follow-up. If you have additional questions, you may rejoin the queue. Please be advised this call is being recorded at the company's request. I would now like to turn the conference over to Lindsay Allen, Head of Investor Relations and Communications. Please proceed, ma'am.

Good morning, and thank you for joining us today to discuss our third 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 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 made based on our current beliefs, plans, and expectations and are made pursuant 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 Rolivio and Albreoza, statements regarding our current and planned clinical trials and regulatory developments and the expected timing thereof, our business and marketing strategy and outlook, and our expected financial performance. Actual events and results could differ materially from those expressed or implied by any forward-looking statements 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 AMAX disclaims any obligation to update such statements unless required by law. Now, I will turn the call over to Justin.

Thank you, Lindsay, and good morning. As we sit here three full quarters into our US launch in ALS, we are proud of what we have accomplished. We are also keenly focused on the work we still need to do to help transform and improve the way that ALS is treated. Our progress with Relivrio continues. As of September 30, 2023, there were roughly 3,900 people living with ALS taking Relivrio in the U.S. We generated $102.7 million in net product revenues in the third quarter. and $272.3 million in the first three full quarters of launch. We are incredibly pleased with how quickly Relivrio has been adopted at key ALS centers and with our engagement with clinicians. While we will continue our efforts to grow within these centers, we are now expanding our focus beyond those top centers based on our experience in the field and new research that points to the fact that roughly half of all people living with ALS receive care from clinicians that do not specialize in ALS and are likely unaware of the benefits of Relivrio. A key message that you will hear on our call today is that we are continuing to evolve our commercial focus as we look to transform the ALS market. We recognize that it may take time and additional data from Phoenix to reach the many clinicians who have yet to prescribe Relivrio as we work towards our goal that at least 10,000 people will be taking Relivrio at any given time. Margaret will provide additional details. As an organization, we're focused on both delivering on our commercial and R&D goals in the near term and investing for the long term with a pipeline focus on treating neurodegenerative diseases. Importantly, our PHOENIX study is progressing well, and we now expect to report top line data from the 664 participant study in the second quarter of 2024. We continue to be confident in the design and execution of the study. Josh will provide additional details on PhenX, review our pipeline, and share the key conclusions from data we presented at the Northeast ALS Consortium meeting last month. He will also review data from Centaur that was recently published in a prominent peer-reviewed medical journal that reaffirmed the confidence we have in the survival data for Relivio. As a reminder, The Centaur study was the basis for the full approval from the FDA that we received for Relivrio in late September 2022, and our approval with conditions in Canada. We also remain committed to bringing the benefits of Relivrio outside the US and Canada to the more than 200,000 people living with ALS worldwide. Assuming the data from Phoenix is supportive, we plan to seek approval in the European Union as quickly as possible. In addition, We continue to interact with key stakeholders around the world to explore opportunities for access like we did in Israel and France. And we are engaging with regulators in Japan. Relivrio gives us the opportunity to start to transform ALS from symptom management as standard of care to a disease with meaningful interventions. And our team is working hard to accelerate this shift because we know people living with ALS have no time to wait. While we are pleased with the progress we've made to date, there are still many more thousands of people to help and clear opportunities ahead of us for growth in the U.S. and Canada and throughout the world. I will now turn the call over to Margaret to share some additional detail on our commercial launches and plans in the U.S. and Canada.