Axsome Therapeutics, Inc.

Hello, and welcome to the Axiom Therapeutics fourth quarter and full year 2023 conference call and webcast. If anyone should require operator assistance, please press star zero on your telephone keypad. A question and answer session will follow the formal presentation. You may be placed into question queue at any time by pressing star one on your telephone keypad. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Chief Operating Officer Mark Jacobson. Please go ahead, sir.

Good morning, and thank you all for joining us on today's conference call. This morning, we issued our earnings press release, providing a corporate update and details of the company's financial results for the fourth quarter and full year of 2023. The release crossed the wire a short time ago and is available on our website at axon.com. During today's call, we will be making certain forward-looking statements. These statements may include 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, our commercial plans regarding synoviality and our pipeline products, revenue projections and possible intended use of cash and investments. These forward-looking statements are based on current information, assumptions and expectations 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. You are cautioned not to place undue reliance on these forward-looking statements, which are only made as of today's date, and the company disclaims any obligation to update such statements. Joining me on the call today are Dr. Ariel Tabuto, Chief Executive Officer, Nick Pizzi, Chief Financial Officer, and Ari Maizel, Executive Vice President and Head of Commercial. Ariel will provide an overview of the company and progress made in the fourth quarter of 2023, as well as key upcoming milestones. Following Aereo, Nick will review our financial results, then Ari will provide a commercial update. We will then open the line for questions, and questions will be taken in the order they are received. And with that, I will turn the call over to Aereo.

Thank you, Mark. Good morning, everyone, and thank you for joining Axon Therapeutics' fourth quarter and year-end 2023 financial results and business update conference call. 2023 was another strong year for Axone, built on focused commercial execution for our first-in-class marketing products and continued advancement and expansion of our industry-leading neuroscience pipeline. During our first full year as a commercial company, Obelody, our first-in-class oral NMDA receptor antagonist and signal-1 receptor agonist for depression, and Synose, our DNRI and colon agonist for excessive daytime sleepiness, generated combined net product revenue of approximately $205 million. We expect continued revenue growth in 2024, aided by our completed Salesforce expansion, or Velody, and increasing awareness of our differentiated products. Later in the call, Nick will provide details on our quarterly financials, and Ari will provide additional information on our commercial performance. During 2023, our innovative development pipeline also progressed and expanded. We made solid progress in the preparation of our NDAs for AXS07 in migraine and AXS14 in fibromyalgia. We advanced our Phase III trials of AXS12 in narcolepsy and AXS05 in Alzheimer's disease agitation. We initiated a Phase III trial program for sorianfetol in ADHD and announced three additional new indications for sorianfetol. This progress positions us to deliver on multiple potentially value-driving milestones throughout 2024. I will provide a brief update on our industry-leading neuroscience pipeline and expected milestones. Starting with our two NDA stage products, AXS07 for the acute treatment of migraine is on track for an NDA resubmission in the first half of 2024. The NDE submission for AXS14 for the management of fibromyalgia is also tracking for submission in the second quarter of 2024. Now moving on to our late-stage clinical programs. We have completed enrollment in the Phase III symphony trial of AXS12 for the treatment of narcolepsy, and we are on track to report top-line results for symphony during the first quarter. For AXS05, The Phase III Advanced II Trial in the Treatment of Alzheimer's Disease Agitation is tracking for completion in the second half of 2024 based on anticipated enrollment trends and recent treatment market dynamics. Referring to solvory amphetol, the active molecule in Synose. In December, we held an Investor Day event where physician experts provided the scientific and clinical rationale underlying the exploration of solar amphetol in new target indications, including major depressive disorder, binge eating disorder, and shift work disorder. We expect to initiate phase three trials in each of these indications in the first quarter. These new trials complement the ongoing phase three focused trial of solar amphetol in adults with ADHD. FOCUS is tracking for top line results in the second half of 2024. Overall, our development portfolio encompasses five innovative, late-stage, patent-protected product candidates for 10 serious psychiatric and neurologic conditions. If successfully developed, these investigational medicines have the potential to transform the treatment landscape for serious and difficult-to-treat CNS disorders which affect more than 150 million people in the U.S. alone. I will now turn the call to Nick, who will provide details of our financial performance.