Amylyx Pharmaceuticals, Inc.

Good morning. My name is Jenny, and I will be your conference operator today. At this time, I would like to welcome everyone to the Amelix Pharmaceuticals' fourth quarter and full year 2023 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, please press Store 1 on your telephone keypad. To withdraw your question, please press star two. Please limit your questions to one with one follow-up. If you have additional questions, you may rejoin the queue. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to Lindsay Allen, Head, Investor Relations and Communications. Please proceed.

Good morning, and thank you for joining us today to discuss our fourth quarter and full year 2023 earnings. With me on the call are Josh Cohen and Justin Klee, our co-CEOs, Jim Friedes, our Chief Financial Officer, and Dr. Camille Bedrosian, our Chief Medical 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 Segurities Litigation Reform Act of 1995. These statements include, but are not limited to, Our expectations with respect to Relivrio, also known as Albreoza or AMX0035. Statements regarding our current and planned clinical trials and regulatory developments and the expected timing thereof. Our business and marketing strategy and outlook. expectations regarding results of the Global Phase III Phoenix Trial of AMX0035 for the treatment of ALS and the impact of those results on the uptake of Relibrio or Albreoza, the potential to expand global approvals for AMX0035 and ALS and other neurodegenerative diseases, 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. Viewer caution not to place any undue reliance on these forward-looking statements. and AMLEX 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. 2023 was a transformational year for AMLEX. It was the first full year that our commercial product, Relivrio, also known as Albreoza in Canada, was available for people living with ALS. The first full year of launch generated $380.8 million in net product revenue. including $108.4 million in the fourth quarter. We also made great progress on our global expansion, built a pipeline of potential medicines for neurodegenerative disease, and transformed into a profitable company. We continue to have a steady number of new scripts being written in the quarter, and our discontinuation rates and net patients on Relivio remain stable from the third quarter. Prescribing remains concentrated, with roughly 80 prescribers, mostly of major ALS centers, still representing approximately half of all Relibrio prescriptions. We believe that we have significant room to grow with both the ALS specialists at these centers and the general neurologists. We are proud that one year into our launch, thousands of people with ALS in the U.S. and Canada are being treated with our therapy. We know there are tens of thousands more people to help, To reach them and achieve our goal of having at least 10,000 people on Relivrio in the U.S. at any point in time, we are focused on three key initiatives. First, expanding the use of Relivrio with physicians that specialize in ALS, who as a group care for about half of all people living with ALS. Second, increasing awareness of Relivrio among general neurologists and other physicians who care for the other half of all people living with ALS. educating on the importance of sustained treatment with Relivio, coupled with practical strategies to manage side effects. During Q4, we began rolling out these initiatives, and we expect the impact of these efforts will build throughout 2024. On that point, we recently onboarded Dan Monahan as the General Manager and Head of U.S. Commercial. Dan is an accomplished, innovative leader with more than 20 years of experience across marketing, sales, and market access, covering numerous disease states, including his most recent position as VP of CNS Marketing and Portfolio Strategy at Otica. We are excited to have Dan leading our U.S. commercial organization and believe his leadership, approach, and experience will help us with the goal of bringing the benefits of Librio to many more people. Of course, an important aspect of our launch will be our Phase 3 Phoenix data. We are targeting top line data from Phoenix during the second quarter of this year or before. We are thrilled to have Dr. Camille Bedrosian, our new chief medical officer, join us on the call today to discuss Phoenix in more detail. Camille brings nearly 30 years of leadership in developing successful medicines for people living with rare diseases and facilitating global access to them. Her experience will be invaluable as we advance our mission. In addition to our focus on our U.S. launch, we remain committed to bringing the benefits of Relivrio to more than 200,000 people living with ALS worldwide. While the vast majority of people taking Relivrio are in the U.S. and Canada, we have leveraged early access pathways in Europe and Israel in 2023, helping people gain access and generating revenue. We are making progress in Japan, and have met with the pharmaceuticals and medical devices agency to discuss a potential regulatory path forward. We also continue to engage with key stakeholders around the world to identify other potential opportunities for pathways to access. Our long-term goal is to transform ALS from a disease for which symptom management is the standard of care to a disease that is treatable. Relivrio is an important tool in that transformation as it is the first and only therapy in ALS that has been shown to slow disease progression and help maintain functional independence in the same clinical trial and extend overall survival in a longer-term post-op analysis. We have made significant progress in our first full year of launch. We look forward to continuing our work this year to reach the many more thousands of people living with the ALS in the U.S., Canada, and globally that can benefit from treatment. I will now turn the call over to Jim to discuss our financial results for the fourth quarter and full year of 2023.