Vanda Pharmaceuticals Inc.

Good afternoon. My name is Jeannie and I will be your conference operator today. At this time, I would like to welcome everyone to the Q4 2023 Vanda Pharmaceuticals, Inc. Earnings Conference Call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during that time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. Thank you. I would like now to turn the call over to Kevin Moran, Vanda's Chief Financial Officer. Mr. Moran, you may begin your conference.

Thank you, Jeanne. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceutical's fourth quarter and full year 2023 performance. Our fourth quarter and full year 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 editor 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 NANDA's fourth quarter and full year 2023 results. I will briefly discuss key updates, and then I will ask our general counsel, Tim Williams, to provide a brief update on litigation matters before turning the call over to Kevin Moran to discuss our financial results. We have significantly advanced our development pipeline, now with three PDUFA action dates in 2024, including our supplemental new drug application, or SNDA, for bipolar disorder in adults, with a PDUFA date in April of 2024, and our new drug application, or NDA, for gastroparesis, with a PDUFA date in September. On our supplemental NDA for head luce in the treatment of insomnia, as we previously communicated this week, our SNDA was accepted for filing and is under review by the FDA with a PDUFA target action date of March 4, 2024. Earlier this week, we announced that we had received a notification from the FDA stating that the FDA had identified deficiencies that preclude discussion of labeling and post-marketing requirements and commitments at this time. No deficiencies were disclosed by the FDA in the notification, and the FDA stated that the notification does not reflect a final decision on the information under review. However, frequently, such a communication from the FDA is followed by a complete response letter. Subsequent to that development on February 6, 2024, Vanda filed suit in the U.S. District Court for the District of Columbia challenging the FDA's conduct in reviewing the insomnia S&DA. Vanda is asking the DC District Court to compel the FDA to adhere to the legally mandated 180-day review period for S&DAs and to declare as unlawful and void the regulations the FDA relies upon to issue complete response letters. On FNAPT for bipolar I disorder, as previously discussed in December of 2022, we announced positive results in our Phase III clinical study of FNAPT in acute manic and mixed episodes with bipolar I disorder in adults. Our supplemental NDA for FNAPT in bipolar I disorder in adults has been accepted for filing by the FDA, and the target action date has been set as April 2nd, 2024. We believe that this potential label expansion represents a significant opportunity for the FNAF franchise, given the high prevalence of bipolar disorder in the United States. The estimated prevalence of bipolar disorder in the U.S. adult population is multiple times larger than the estimated prevalence of schizophrenia. Additionally, on tradipitant, for patients with gastroparesis, our new drug application has also been accepted for filing by the FDA, and the target action date has been set as September 18, 2024. The FDA package, supported by the results from clinical ethical studies 2301 and 3301, which we believe demonstrate substantial evidence of efficacy of tradipitin in this indication, as well as a safety database to support the tolerability of this drug. The expanded access program continues with multiple patients, have been treated for at least six months, and the longest-treated patient for more than three years. We're pleased with our revenue performance, despite the challenges of the at-risk launches of generic Catalios products. Over the course of this year, we have taken a number of actions intended to position the commercial business for continued success, both with respect to existing products and indications, as well as potential future products and indications. These include preparations for the potential near-term expansion of the FNAF franchise if we receive FDA approval for Bipolar I Disordered Adults. During the fourth quarter of 2023, we completed a transformative acquisition as we obtained the U.S. and Canadian rights to Ponvori, Ponestimod, from Actelium Pharmaceuticals Limited, a Johnson & Johnson company, for 100 million U.S. dollars. Ponvori is a once-a-day oral selected sphingosine 1-phosphate receptor 1 modulator approved by the FDA and Health Canada to treat adults with relapsing forms of multiple sclerosis. Additionally, Ponvori is a potential therapeutic candidate for the treatment of a diverse group of inflammatory and autoimmune disorders ranging from psoriasis to ulcerative colitis. Most recently, the US Patent and Trademark Office issued an Odds of Allowance for Punvori patent application 17962968, which when issued is anticipated to expire on October 10, 2042. On the clinical side, as previously reported, In May of last year, we announced positive results from the first Phase III study of tradipitin in the treatment of motion sickness. And subsequent to that, we initiated a second Phase III study, which is now already 50% enrolled. We plan to pursue FDA approval of tradipitin for motion sickness upon completion of the clinical development program. And outside of this update of the traductor motion sickness program, we continue to progress our robust clinical development pipeline, which includes multiple products across a wide range of therapeutic areas. With that, I will now ask Tim Williams, our general counsel, to provide a brief update on litigation matters. Tim.