Axsome Therapeutics, Inc.

Good morning and welcome to the Axiom Therapeutics third quarter 2025 earnings conference call. My name is Daryl and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, there will be a question and answer session and instructions will be given at that time. Please note that this call is being recorded. I would now like to hand the call over to Darren Oplin, Senior Director of Corporate Communications. Please go ahead.

Thank you, Daryl. Good morning, everyone. Thank you for joining us for ACTSOM's Third Quarter 2025 Earnings Conference Call. With us today are Dr. Ariel Tabito, our Chief Executive Officer, Nick Pizzi, our Chief Financial Officer, and Ari Maisel, our Chief Commercial Officer, who will begin our call with prepared remarks. Marcus Jacobson, our Chief Operating Officer, and Hunter Murdoch, our General Counsel, will also be available for Q&A. This morning, to 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 a description of these and other risks. You 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 now, I'll turn the call over to Ariel.

Thank you, Darren, and good morning, everyone. Axiom continues to lead in CNS innovation, driven by disciplined execution and a clear focus on sustained growth and value creation. In the third quarter, we delivered strong revenue growth with total revenue of $171 million across our three marketed products, representing a 63% increase year over year. Ovality continues to gain traction as a differentiated treatment for major depressive disorder, driven by strong underlying demand. We're pleased with the pace of Ovality's performance, which is tracking well against our long-term expectations and underscores the significant opportunity for continued growth ahead. The NOSI remains on a steady trajectory, with year-to-date sequential growth nearly double that of the same period last year, a testament to the product's durable performance and expanding adoption. And Bravo completed its first full quarter of commercial launch in Q3. Our focus now is to continue strengthening the foundation for long-term success by broadening patient access and driving awareness with clinicians. Nick and Ari will speak in more detail about our financial and commercial performance and the strategic execution driving momentum across Axiom's portfolio. Beyond our continued commercial growth, Axiom's R&D engine is advancing a robust pipeline of late-stage programs with the potential to deliver transformative therapies for patients and significant value to our shareholders. Over the coming months, we expect meaningful activity across our late stage programs, including two NDA stage programs and multiple registrational trials underway or initiating. I'd like to start with our top priority areas in psychiatry and neurology, Alzheimer's disease agitation, narcolepsy, and ADHD. These are areas where we see substantial opportunity to transform patient outcomes leverage our commercial infrastructure, and unlock significant value. First, we are pleased to share that we have submitted our supplemental NDA for AXS05 and Alzheimer's disease agitation, and we look forward to announcing the FDA's decision on acceptance of the filing. This submission is an important milestone for AXS05 and for the millions of patients and caregivers affected by this serious and underserved condition. The addressable market for Alzheimer's disease agitation is substantial, and the unmet need is high with currently only one product approved. AXS05 represents a first-in-class mechanism of action that has the potential to set a new standard in the treatment of AD agitation. Work is already underway to efficiently scale our commercial platform to deliver an impactful launch if approved. As a reminder, We are also developing AXS05 in smoking cessation, and we are on track to initiate a Phase 2-3 trial in the syndication this quarter. Our next pipeline priority area is narcolepsy. We continue to target the submission of our NDA for AXS12 for the treatment of cataplexy in narcolepsy in the fourth quarter of this year. AXS12 represents a highly differentiated opportunity to address critical gaps in current treatment. Up to 70% of patients suffer from cataphylaxis, and many continue to experience inadequate relief or poor tolerability to existing treatment options. We are excited about AXS-12's potential to make a meaningful difference for patients living with narcolepsy. We also like its strategic fit with our existing sleep franchise, which we anticipate will enable highly efficient and synergistic launch if approved. For ADHD, Sol-Re-Infratol has demonstrated positive results in adults in the FOCUS Phase III trial completed earlier this year. The next step is the Phase III trial in children and adolescents, which we plan to initiate in the fourth quarter of this year. If successful, this indication could substantially expand the opportunity for Sol-Re-Infratol beyond its currently approved indications. As a reminder, we are also developing Sol-Re-Infratol in three additional indications. MDD with excessive daytime sleepiness, binge eating disorder, and shift work disorder. For MDD, we anticipate the initiation of a phase three trial in adults with MDD with excessive daytime sleepiness this quarter. Next year, we expect top line results from the ongoing ENGAGE phase three trial in binge eating disorder and the SUSTAIN phase three trial in shift work disorder and we look forward to providing progress updates in the near future. Turning to AXS-14, we are finalizing preparations for our planned phase three trial in fibromyalgia, which we expect to launch before year end. These milestones highlight the continued expansion of Axone's leading neuroscience pipeline, spanning multiple psychiatry and neurology indications with significant unmet medical needs and substantial long-term growth potential. All in all, our portfolio of novel medicines is robust and diverse, and our late-stage pipeline is deep and rapidly advancing, uniquely positioning Axon to deliver substantial near and long-term value through multiple highly differentiated paths. With just three years as a fully integrated R&D and commercial organization, Axiom is shaping the frontier of differentiated innovation in brain health. The fundamentals of our business have never been stronger, and we are excited to continue building on this foundation to drive further growth. With that, I'll hand the call over to Nick to review our financial results for the quarter.