Vanda Pharmaceuticals Inc.

ladies and gentlemen thank you for standing by and welcome to the q4 2022 vanda pharmaceuticals inc earnings conference call i would now like to turn the call over to kevin moran vanda's chief financial officer please go ahead thank you mandi good afternoon and thank you for joining us to discuss vanda pharmaceuticals fourth quarter and full year 2022 performance our fourth quarter and full year 2022 results

were released this afternoon and are available on the SEC's EDGAR system and on our website, www.VanaPharma.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 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 Paliamaropoulos.

Mahalas Paliamaropoulos Thank you very much, Kevin, and good afternoon, everyone. Thank you for joining us to discuss VANDIS fourth quarter and full year 2022 results. I will first discuss key highlights from our clinical programs, 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 to discuss our commercial progress and financial results. I will begin with our announcement of positive results in the phase three clinical study of FNAPT in the treatment of bipolar I disorder in adult patients. This was a large placebo-controlled study conducted in the U.S. and Europe that enrolled approximately 400 patients with acute episodes of bipolar 1 disorder. The primary endpoint of that study was measured in week four of treatment, and it was assessed by the Young Mania Rating Scale, YMRS, a rating scale of clinical severity in the core symptoms of mania. At the end of the study, week four, FNAP-treated patients showed a larger improvement than placebo-treated patients, and this difference was highly statistically significant. YMRS was assessed at the end of weeks one, two, three, and four. Statistically significant benefit in the FNAP group over placebo was observed as early as week two of treatment. Consistent with the total YMRS score, The individual YMRS subscale items also showed improvement in the FNAPT group versus the placebo group over the course of the four-week study. Other outcomes, such as clinical global impression of severity and clinical global impression of change, also achieved high statistical significance. We plan to submit a supplemental new drug application, SNDA, for FNAPT for the treatment of acute manic and mixed episodes associated with bipolar 1 disorder in adults in the first half of this year, 2023. As a reminder, bipolar disorder is estimated to affect 2.8% of the U.S. adult population, a number approximately up to 10 times higher than the estimated prevalence of schizophrenia. Therefore, an indication of bipolar disorder presents a substantial opportunity to expand the FNAP franchise above and beyond the already approved indication of schizophrenia in adults. We also reported results for DQW765, a novel alpha-7 nicotinic acetylcholine receptor parcel agonist from clinical study 2201 in the treatment of acute performance anxiety in social situations. In study 2201, participants who received VIC-W765 showed numerically lower stress levels compared to those who received placebo. The stress level was assessed by the Subjective Units of Distress Scale, SUDS, a self-rating scale of level of nervousness or distress ranging from 0 to 100, at multiple time points during the duration of the TSST test. In particular, in female participants, approximately 70 percent of the total participants, a larger magnitude of effect was observed, which was also statistically significant. This is the first time that an alpha-7-eucotinic acetylcholine receptor parcel agonist has shown efficacy in a clinical study of performance anxiety, and we look forward to confirming the efficacy in future studies. On tradipitin, preparation of the new drug application NDA in gastroparesis is ongoing, with an expected FDA submission in the first half of 2023. Additionally, an open-label study of tradipitin in patients with gastroparesis is ongoing, with the first 400 patients having already completed this 12-week study. Patients continue to seek access to the expanded access program, with a number of patients having been treated with tradipitant for over a year. On tradipitant for the treatment of motion sickness, enrollment in the clinical program is over 75 percent complete, and we expect results by mid-2023. We've experienced great success in recruitment as a result of target advertising, some of which you may have seen during Sunday football and other sporting events. On hetlios, we continue to pursue regulatory approvals for hetlios in the indications of insomnia and jet lag disorder, supported by robust clinical program results that we have previously reported. We look forward to bringing our clinical programs to successful completion in pursuit of regulatory filings and approvals. As we reported today, 2022 was another successful year commercializing heterozygous for non-24 and SMS and FNAF for schizophrenia. The adverse decision in December by the district court on the heterozygous under litigation poses a significant challenge, but we remain focused and determined in asserting our patents. I will now turn the call to Tim Williams, our general counsel, to discuss this and other legal matters. Tim?