Vanda Pharmaceuticals Inc.

Thank you for standing by. My name is Meg and I will be your conference operator today. At this time, I would like to welcome everyone to the Q2 2024 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 this time, simply press star followed by the number one on your telephone keypad. If you would like to redraw your question, press star one again. Thank you. I would now like to turn the conference over to Mr. Kevin Moran, Vanda's Chief Financial Officer. You may begin.

Thank you, Meg. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceuticals' second quarter 2024 performance. Our second quarter 2024 results were released this afternoon and are available on the SEC's EDGAR system and on our website. www.bandaffarma.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 we open 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 8K, and other filings with the SEC, which are available on the SEC's EDGAR 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. Mahalas Polymeropoulos.

Thank you very much, Kevin, and good afternoon, everyone. Thank you for joining us to discuss VANDAS second quarter 2024 results. The beginning of the quarter was marked with a significant milestone of the FDA approval of FNAP for the treatment of bipolar I disorder. This approval expands the commercial potential of FNAP, and lays down the foundation for our psychiatry portfolio. As a result of this development, we focused our operational efforts in expanding and strengthening our commercial organization to better position us to maximize the commercial value of the asset. In a short period of time, we have increased by three times the size of our sales force significantly expanded our FNAP speakers program and began engaging with prescribers. In addition, we're building our marketing campaign, and we expect to reach full operational capacity in the fourth quarter of this year. In addition to these commercial efforts, the clinical development of the psychiatry portfolio is advancing, with a new drug application filing expected in early 2025 for milsaperidone, an active metabolite of FNAPT for the treatment of bipolar disorder and schizophrenia. We're also preparing to initiate the clinical program in major depression with milsaperidone in the fourth quarter of this year. The long-acting injectable program of alloperidone is continuing with the expected initiation of the Phase III study for the maintenance of treatment in schizophrenia later this year. We're excited with the prospects of our psychiatry franchise that we expect to provide significant value to patients and provide Vanda with significant revenue growth well into the future. With the acquisition of Punvori from Janssen and the full transfer of ownership to Vanda, we have also focused in building a commercial organization to promote Punvori in the treatment of multiple sclerosis. We're now close to completing the hiring of a new specialty sales force and initiating patient support and marketing activities in the near future. We believe that Punvori provides a useful and competitive option among the disease-modifying treatment modalities for patients with multiple sclerosis. We're confident that increasing awareness among prescribers and patients will be able to further drive utilization and allow for a return to revenue growth in the near future. We're also working towards initiating clinical programs in psoriasis, and ulcerative colitis, where Ponvori can become a significant treatment option as a once-a-day oral medication with quick onset of action as well as quick reversibility of its immune regulatory effect. Our third commercial product, Hetlio's oral capsules for non-24-hour sleep-wake disorder, continues to face revenue erosion due to the introduction of generic products. Nonetheless, patient loyalty to our quality product has allowed us to maintain a significant market share in this patient population. Hetlios LQ approved for children with Smith-Mageni syndrome is not affected by generics competition and continues to serve the Smith-Mageni syndrome community. We have recently applied for marketing authorization in the EMA for both Hetlios and Hetlios LQ for Smith-Magenius syndrome. Hetlios is currently approved for non-24 in the European Union and is actively commercialized in Germany. Hetlios is not facing generic competition in the EU at this time. In addition to our commercial efforts, Hetlios is under development for delayed sleep-wake phase disorder, and Hetlios LQ is under development for the treatment of pediatric insomnia. Both disorders have currently no FDA-approved treatments and represent a significant unmet medical need. I will turn to our portfolio of assets under development and offer some highlights. The new drug application for Tredipitant for the treatment of symptoms of gastroparesis remains under review by the FDA with a PDUFA target action date of September 18, 2024. We continue to believe that the evidence provided in the NDA, including from qualified experts, constitutes both substantial evidence of efficacy and sufficient safety information to support the approval of tradipitin to treat the symptoms of gastroparesis. We believe that the agency should convene an advisory committee to assist in reviewing this application with experts in the field given the novelty of the mechanism of action pursued for this indication and the lack of approval of any drug in this indication in over 40 years. Despite our repeated requests for an advisory committee meeting to consider the NDA, the FDA has yet to grant one. In the late cycle meeting held in June, the FDA stated that it would take into consideration our request for an advisory committee meeting. We have followed up on this request several times, but have yet to receive a response. On May 31st, we received a discipline review letter in which, among other comments, The FDA provided a preliminary notice that they had identified deficiencies that preclude discussion of labeling and post-marketing requirements and commitments, but that their comments do not reflect a final decision on the information reviewed and should not be construed to do so. We requested clarification from the FDA as to whether we should expect labeling communication prior to the PDUFA date, but the FDA has yet to respond. Nonetheless, we remain confident in the body of evidence we have presented, and we await clarity on next steps by the FDA. On tradipitin again, in the second quarter, we reported on positive results for our second Phase III study in motion sickness. Completing, therefore, our clinical efficacy packets with two positive Phase III studies and a supporting positive Phase II study. The studies were conducted under real-world conditions in the coastal water of the United States. We plan to seek FDA approval for tradipitant in the prevention of vomiting in motion sickness later this year. With that, I'll turn now the call back to Kevin Moran to discuss our financial results. Kevin.