Vanda Pharmaceuticals Inc.

Good afternoon. My name is Emma, and I will be your conference operator today. At this time, I would like to welcome everyone to the Vanda Pharmaceuticals third quarter 2022 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 withdraw your question, again, press the star one. Thank you. I would now like to hand the call over to Kevin Moran, Vanda's Chief Financial Officer. Kevin, you may begin your conference.

Thank you, Emma. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceuticals' third quarter 2022 performance. Our third quarter 2022 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. Additionally, we have Tim Williams, our general counsel, and Gunther Biersnix, our senior vice president of business development and R&D committee member. 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 discussion and analysis of financial condition and results of operations sections of our annual report on Form 10-K, for the fiscal year ended December 31st, 2021, as updated by our subsequent quarterly reports on Form 10Q, 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. Mahalis Polymeropoulos.

Thank you, Kevin, and good afternoon, everyone. Thank you for joining us to discuss Vanda's third quarter 2022 results. Over the last quarter, Vanda continued to focus on enhancing performance of its current commercial products, advancing clinical programs, and leveraging innovation to position the company for long-term growth. I will discuss some highlights of our clinical and regulatory efforts, and Kevin will discuss our commercial progress. First on FNAPT, our clinical program pipeline is advancing with the recent completion of enrollment in the FNAPT Bipolar Mania Clinical Study. for which we expect results by the end of this quarter. Additionally, we have completed enrollment in our VQW-765 study in performance anxiety, for which also we expect results by end of this quarter. On tradipotent, preparation of the new drug application in gastroparesis is ongoing, with FDA submission expected in the first half of 2023. The submission will include results from two adequate and well-controlled studies in patients with idiopathic and diabetic gastroparesis, which provides substantial evidence of effectiveness in the indication. If approved, tradiptin would be the first treatment in more than 40 years approved by the FDA for people with gastroparesis. Additionally, a 400-patient open-label study of tradiptin in patients with gastroparesis is ongoing, which will provide further information on the safety and efficacy of tradipitin in gastroparesis. We recently presented results of the pooled analysis from studies VLY686-3301 and VLY686-2301, which included a total of 342 patients, 175 on tradipitin, 167 on placebo, which showed significant improvements in the clinical endpoints of change of nausea, percent nausea-free days, and the gastroparesis core symptom improvement scale, GCSI, at week four of treatment. In the subpopulation, which excludes non-protocol-compliant patients, as determined by PK analysis, a total number of 283 patients, Highly significant effects were seen in each of these parameters. Improvements were also seen across the other core symptoms of gastroparesis as well. This work was recently presented at the American College of Gastroenterology Conference and received the Presidential Poster Award. Tradipitence efficacy is also appreciated by patients who are participating in an expanded access program some already for over a year. Tridipitin in motion sickness. On tridipitin, we're also progressing with the clinical program in motion sickness with a pivotal study currently ongoing and expected to be completed in the first half of 2023. HETLIOS. Enrollment is ongoing in the clinical development programs of HETLIOS for the treatment of delayed sleep phase disorder, and for sleep disturbances in autism spectrum disorder. Additionally, we're preparing for the submission of a supplemental NDA for hetlias in the treatment of insomnia. The submission will include results of three adequate and well-controlled studies, one four-week study in people with primary insomnia, and two trans-insomnia studies. induced by phase advance of the sleep-wake cycle. These studies show that hetlius is effective in improving sleep onset difficulty in people with primary insomnia, with effect observed as early as the first night of treatment. This supplemental NDA of hetlius for insomnia is planned to be submitted to the FDA this quarter. VPO227 and cholera. We recently announced that the FDA has granted orphan drug designation for VPO227 for the treatment of cholera. Cholera remains a major public health challenge and recognized and met medical need despite decades-long public health efforts, and we're excited about the potential of VPO227 to treat patients that suffer from cholera. We expect to submit an investigational new drug application to the FDA for VPR227 in 2023. Finally, we recently announced a research and development agreement with OLIPAS of Korea to jointly develop a set of anti-sensory oligonucleotides, or ASOs, based on OLIPAS's proprietary modified peptide nucleic acids. This evolving discovery and development platform is intended to support VANDER's development of anti-essence oligonucleotide-based precision medicine therapeutics. Tim Williams, our general counsel, will now discuss highlights of our legal regulatory activities. Tim?