Axsome Therapeutics, Inc.

Good morning and welcome to the Axiom Therapeutics fourth quarter and full year 2024 conference call. Currently, all participants are in listening mode. Later, there will be a question and answer session and instructions will be given at that time. As a reminder, today's conference call is being recorded. I'll now turn the call over to Darren Upland, Director of Corporate Communications at Axiom Therapeutics. Please go ahead.

Thank you. Good morning and thank you all for joining us on today's conference call. This morning we issued our earnings press release, providing a business update and details of the company's financial results for the fourth quarter and full year of 2024. The release crossed the wire a short time ago and is available on the investor section of our website, along with the earnings presentation accompanying today's call. Those joining by a webcast may advance through the slides at any time during the discussion. During today's call, we will be making certain forward-looking statements regarding, among other things, the efficacy, safety, and intended utilization of our investigational agents, our clinical and non-clinical plans, our plans to present or report additional data, the anticipated conduct and the source of future clinical trials, regulatory plans, future research and development plans, commercial plans, and possible intended use of cash and investments. These forward-looking statements are based on current information, assumptions, and expectations of future events that are subject to change and involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports. Your caution not to rely on these forward-looking statements which are made only as of today's date, and the company disclaims any obligations to update such statements. Joining me on the call today are Dr. Ariel Tabito, Chief Executive Officer, Nick Pizzi, Chief Financial Officer, Ari Mazel, Chief Commercial Officer, Hunter Murdoch, General Counsel, and Mark Jacobson, Chief Operating Officer. Ariel will begin with opening remarks, including an overview of the important progress we've made in 2024 and to look ahead into the rest of 2025. Following Ariel, Nick will review our financial results, and then Ari will provide a commercial update. We will then open the line for questions, which will be taken in the order they are received. And with that, I'll turn the call over to Ariel.

Thank you, Darren. And good morning, everyone. In the last two and a half years as a fully integrated R&D and commercial organization, Axome has both expanded and deepened its leadership within CNS. Our portfolio today comprises three differentiated in-market products, three innovative product candidates in regulatory submission stage, and numerous ongoing phase three trials. This broad portfolio positions us to potentially commercialize seven products or indications through 2027, allowing us to deliver significant innovation to patients and value to shareholders. 2024 was another year of strong execution for Axome. For the year, we delivered total net product revenue of $386 million, reflecting high double-digit year-over-year growth for Velody and Sunozzi. We expect continued growth in 2025, supported by our second completed Salesforce expansion for Ovelity, further improvements in market access dynamics, and increasing awareness of our differentiated products. Based on the recent performance, Ovelity is on track to reach blockbuster potential. Most recently, we received US approval of Simbravo on January 30th, representing a novel oral acute treatment for migraine. Based on its clinical profile, Sembravo represents an important development for patients living with migraine. With Sembravo, we now have three commercial stage products and are actively preparing for its commercial launch. Before turning the call over to Nick and Ari, who will expand on the strong financial and commercial performance in the year, I'd like to provide an update on our rapidly advancing late stage pipeline and speak about key priorities for 2025. 2024 was highly productive from a clinical development perspective as we read out five pivotal trials and initiated three phase three trials across our portfolio. Our R&D execution in 2024 positions us to potentially deliver several important milestones in 2025. Starting with AXS05, for the treatment of Alzheimer's disease agitation. Last year, we completed the phase three clinical program in this indication, which consisted of four controlled phase three efficacy trials and a long-term safety trial. With the positive results from this comprehensive program in hand, we plan to submit an NDA for AXS05 for the treatment of Alzheimer's disease agitation to the FDA in the second half of 2025. Moving on to AXS-12 for the treatment of narcolepsy with cataplexy. Last year, we also completed the clinical program for this product candidate, which included three controlled efficacy trials and a long-term safety trial. Based on the positive results from these studies, we plan to submit an NDA for AXS-12 for the treatment of cataplexy in patients with narcolepsy to the FDA in the second half of 2025. As it relates to our NDA4AXS14 in fibromyalgia, we are in the publication stage of the submission and expect to submit the NDA to the FDA this quarter. Apart from the activity related to these NDA submissions, we anticipate top line readouts from several phase three trials in the near term. These include the eMERGE phase three trial evaluating Sembravo, In patients with prior inadequate response to oral CGRP inhibitors, the FOCUS phase III trial of solar amphetol in ADHD, and the PARADYME phase III trial of solar amphetol in major depressive disorder. Top line results for all three of these studies are on track for the first quarter of 2025. Enrollment for the ENGAGE study of solar amphetol in binge eating disorder And the sustained study of Solver-Anvital and SHIFT work disorder continue to progress with top line results for both studies anticipated in 2026. All in all, across our development portfolio, we expect NDE submissions for three product candidates and top line readouts from three phase three trials in the coming months. I am proud of the excellent progress we've made as an organization and look forward to another transformative year as we build upon our commercial success and advance our CNS pipeline. With that, I'll hand the call over to Nick.