Axsome Therapeutics, Inc.

Hello, and welcome to the Axiom Therapeutics first quarter 2023 financial results 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 ask a question at any time by typing it into the ask a question feature on your screen. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Mark Jacobson. Please go ahead, Mark.

Thank you, operator. 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 first quarter 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 uncertainty that may cause actual results that 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. We 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 Peavy, Chief Financial Officer, and Lori Engelbert, Executive Vice President of Commercial and Business Development. Ariel will provide an overview of the company and progress made in the first quarter of 2023, as well as upcoming milestones. Following Ariel, Nick will review our financial results And then Lori will provide a commercial update. We will then open the line for questions. Questions will be taken in the order they are received. And with that, I will turn the call over to Ariel.

Thank you, Mark. Good morning, everyone. And thank you for joining Axone Therapeutics first quarter, 2023 financial results and business update conference call. We saw strong performance in all areas of our business in the first quarter, which included Advancing the commercialization of Ovelity and Synozy. Progressing our late stage product pipeline. Out-licensing XUS rights for Synozy. And strengthening our financial position. Total net product sales in the quarter were 28.8 million, driven by strong performance for Ovelity and solid performance for Synozy. Based on the current prescription trends, We are pleased that our two marketed products are now helping a growing number of patients living with depression and with excessive daytime sleeviness. Later on the call, we will provide further details on our commercial performance for Ovelity and Synosi. The first quarter was an important milestone for Axon as it was the first full quarter of sales for Ovelity. We have also had control of the US rights to Synozy for about one year. Earlier in the quarter, we announced the out-licensing of our ex-US marketing rights for Synozy in Europe, the Middle East, and North Africa to PharmaNovia. PharmaNovia shares our excitement and commitment to maximize the potential of Synozy for patients worldwide. We continue to see significant potential for Synozy both in the current indications as well as in potential new indications. With regards to new indications, we remain on track to initiate a phase three trial of sol-reamphytol, the active molecule in Synose in ADHD in adults in the second quarter. In addition to sol-reamphytol for ADHD, the rest of our leading CNS pipeline includes AXS07 for migraine, AXS12 for narcolepsy, AXS14 for fibromyalgia, and AXS05 for Alzheimer's disease agitation and for smoking cessation. For AXS07, our developmental candidate for the acute treatment of migraine, manufacturing activities are moving forward to enable the resubmission of this NDA, which is slated for the second half of this year. With AXS12, our product candidate for the treatment of narcolepsy, We continue to expect top line results from the pivotal phase three symphony trial in the first half of this year. With AXS14, our product candidate for the treatment of fibromyalgia, manufacturing, and other activities related to preparation for the planned submission of an NDA are continuing. And we expect to be in a position to submit the NDA for this product candidate in the second half of this year. With regards to XSO5 for the treatment of Alzheimer's disease agitation, enrollment in the phase three advanced two trial is progressing, and we anticipate completing this trial in the first half of 2024. In addition, we plan to initiate a phase two three trial of XSO5 in smoking cessation in the fourth quarter of 2023. In sum, we expect the next 12 to 18 months to be eventful, as we drive the commercialization of Avelity and Synosi, and as we advance our research and development pipeline. I will now turn the call over to Nick, who will provide details of our financial performance.