Vanda Pharmaceuticals Inc.

Good afternoon. My name is David and I'll be your conference operator today. At this time, I'd like to welcome everyone to the Q1 2023 Vanda Pharmaceuticals Inc. Earnings Conference Call. Today's conference is being recorded. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there'll be a question and answer session. If you'd like to ask a question during this time, simply press the star key followed by the number one on your telephone keypad. If you'd like to withdraw your question, press star one once again. I'd now like to turn the call over to Vanda Pharmaceuticals Chief Financial Officer, Kevin Moran. You may begin your conference.

Thank you, David. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceuticals' first quarter 2023 performance. Our first quarter 2023 results were released this afternoon and are available on the SEC's EDGAR system and on our website, www.vandapharma.com. In addition, we are providing live and archived versions of this conference call on our website. Joining me on today's call is Dr. Mahalis Polymeropoulos, our President, Chief Executive Officer, and Chairman of the Board, and Tim Williams, our General Counsel. Following my introductory remarks, Mahalis will update you on our ongoing activities. I will then comment on our financial results before opening the lines for your questions. Before we proceed, I would like to remind everyone that various statements that we make on this call will be forward-looking statements within the meaning of federal securities laws. Our forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances, and uncertainties. These risks are described in the cautionary note regarding forward-looking statements, risk factors, and management's discussion and analysis of financial condition and results of operations, sections of our most recent annual report on Form 10-K, as updated by our subsequent quarterly reports on Form 10-Q, current reports on Form 8-K, and other filings with the SEC, which are available on the SEC's EGGR system and on our website. We encourage all investors to read these reports and our other filings. The information we provide on this call is provided only as of today, and we undertake no obligation to update or revise publicly any forward-looking statements we may make on this call on account of new information, future events, or otherwise, except as required by law. With that said, I would now like to turn the call over to our CEO, Dr. Mahalis Polymeropoulos.

Thank you very much, Kevin, and good afternoon, everyone. Thank you for joining us to discuss Vanda's first quarter 2023 results. I will first discuss key highlights from our clinical programs, and then I will ask our general counsel, Mr. Tim Williams, to provide a brief update on litigation matters before turning the call over to Kevin to discuss our commercial progress and financial results. The first quarter has been both busy and challenging. The at-risk launch of generic tazimelkin had a significant impact on the performance of hetlias and the services to our patients, as well as on our operations as a whole. We expect the challenges to continue, and we await the decision on our part in litigation from the Federal Circuit Court of Appeals. Nonetheless, we're committed to serving our patients and prescribers for both FDA-approved hetlias indications. This quarter has been exceptionally busy on the research and development front. Following the highly positive results for FNAP in bipolar I disorder, we're working on the submission of a supplemental NDA for the addition of the bipolar indication to the FNAP label. We believe that expansion of the FNAP label will potentially allow us access to a large commercial opportunity as the number of patients with bipolar disorder far exceed that for patients with schizophrenia. For HETLIOS, we expect to request a label expansion to include a treatment of patients with insomnia who experience difficulties falling asleep. In support of this application, we're including three studies, including a four-week study in patients with insomnia and two transient insomnia studies. We believe that hetlius has a potentially compelling profile for treating patients with this type of insomnia and could represent a significant clinical advance as well as a significant commercial opportunity. In addition to these two supplemental NDAs, we're preparing the submission of a new drug application for tradipitin in gastroparesis. In support of this application, will be submitting to the FDA results of three clinical studies that we believe demonstrate substantial evidence of efficacy of tradipton in this indication, as well as a safety database to support the tolerability of this drug. The expanded access program is ongoing, with multiple patients treated for at least six months and the longest-treated patient more than two years. we expect to complete our submission in the coming months. In addition to these three planned regulatory submissions, we're expecting the results of our pivotal motion sickness study with tradipidant by mid-2023. Besides these late state advances, we're also proceeding with early stage programs, including the study of social performance anxiety with VQW051. As we're focused in the short term on our three regulatory filings, we're also diligently pursuing a broader regulatory strategy aimed at increased transparency and accountability of our regulatory agency that is designed to facilitate and not impede innovation in the service of people's happiness. With that, I will turn over the call to our general counsel, Tim Williams. Tim?