Axsome Therapeutics, Inc.

Good morning, and welcome to the Axiom Therapeutics fourth quarter and full year 2025 earnings conference call. My name is Kevin, and I'll be your operator for today's call. At this time, all participants are in listen-only mode. Later, there will be a question-and-answer session, and instructions will be given at that time. Please note, this call is being recorded. I would now like to hand the floor to Ashley Dong, Director of Investor Relations. Ashley, please go ahead.

Thank you. Good morning, and thank you all for joining Accent's fourth quarter and full year 2025 earnings conference call. With us today are Dr. Ariel Tabuto, our Chief Executive Officer, Nick Pizzi, our Chief Financial Officer, and Ari Maizel, our Chief Commercial Officer, who will begin our call with prepared remarks. Mark Jacobson, our Chief Operating Officer, and Hunter Murdoch, our General Counsel, will also be available for Q&A. Before we begin, I encourage everyone to visit the investor section of our website to find the press release and presentation for today's call. Please note that today's discussion includes forward-looking statements regarding our financial performance, commercial strategy, and operational plans, including research, development, and regulatory activities. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that may cause actual results to differ materially. Please refer to our SEC filings, including our quarterly and annual reports, for description of these and other risks. We are cautioned not to rely on these forward-looking statements, which are made only as of today, and the company disclaims any obligation to update such statements. And with that, I'll hand it over to Ariel.

Thank you, Ashley, and good morning, everyone. 2025 was a year of significant commercial research and development progress at Axon. Our commercial business is strong. with Avelity achieving sales of over half a billion dollars in its third full year of launch, Synosy growth accelerating, and Sembravo launching, adding a third pillar of growth. Total revenue for the fourth quarter increased 65% year over year to $196 million, and for the full year increased 66% to $639 million. Our innovative medicines continue to meaningfully improve patient outcomes. Just our current commercialized products have the potential to achieve multi-billion dollars in annual peak sales. To support the continued momentum of our current products and future launches, we have built a technologically enabled scalable commercial platform. Against this backdrop, we are advancing a broad and innovative CNS pipeline, which includes five novel product candidates across nine high impact indications. I will provide an update on our pipeline progress, starting with our SMDA for Ovelity and Alzheimer's disease agitation. We recently announced the acceptance of the SMDA filing and the receipt of priority review designation with a BDUFA action date of April 30th. If approved, Ovelity has the potential to address this prevalent and debilitating condition for which currently only one product is approved. As we approach the April 30th Purdue for date, launch readiness activities are underway, which Ari will discuss later in the call. We are encouraged by the level of interest within the treatment community and expect awareness to continue to build in the quarters ahead. Beyond the opportunity in Alzheimer's disease agitation, we are advancing our plan phase 2-3 trial of AXS05 in smoking cessation. with initiation anticipated in the second quarter. Moving to AXS-12 and narcolepsy. Following receipt of positive FDA pre-NDA meeting minutes, we've made significant progress with our NDA package, and we expect to submit that imminently. With solvary amphetol, we continue to advance this differentiated molecule across multiple new indications, including ADHD, binge eating disorder, MDD with symptoms of excessive daytime sleepiness, and shift work disorder. These new indications represent significant expansion of psoriasis potential to help patients and create value for stakeholders. For ADHD, we recently completed a type B meeting with the FDA, where we reached agreement on the planned phase three studies in pediatric patients. We plan to conduct two phase three trials in parallel, one in children and one in adolescents, and we are on track to initiate both in the first half of this year. For MDD, startup activities are underway for initiation this quarter of a phase three trial of solvianvital in MDD patients with symptoms of excessive daytime sleepiness. For binge eating disorder, our engaged phase three trial of solvianvital in the syndication is progressing, and we expect top line results in the second half of this year. Finally, For salvinanfetol and shift work disorder, we now anticipate top-line results in 2027 based on current enrollment trends. Turning to AXS14, we recently initiated the forward study of phase three, double-blind, placebo-controlled randomized withdrawal trial of AXS14 in patients with fibromyalgia. This new study will supplement the two completed positive phase two and phase three trials of AXS14 in the syndication. To complement our late stage pipeline, we recently acquired AZD7325, a novel oral GABA-A alpha-2,3 receptor positive allosteric modulator. We plan to evaluate AXS17, the new designation for this compound, for the treatment of epilepsy based on compelling data in preclinical seizure models. Further, AXS 17 has demonstrated a favorable safety profile in over 700 patients to date. Phase two trial enabling activities are underway, and we look forward to provide updates on this new development program in the coming months. Taken together, our growing commercial business, the potential label expansion for Velody, and the robust innovation across our pipeline uniquely position us to continue to deliver new treatment options for patients living with CNS disorders. With that, I'll hand the call over to Nick to review our financial results for the quarter.