VNDA - NASDAQ

Ladies and gentlemen, thank you for standing by. My name is Desiree, and I will be your conference operator today. At this time, I would like to welcome everyone to the Third Quarter 2023 Vanda Pharmaceuticals, Inc. Earnings Conference Call. [Operator Instructions] I would now like to turn the conference over to Kevin Moran, Vanda’s Chief Financial Officer. Please go ahead.

Thank you, Desiree. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceuticals’ third quarter 2023 performance. Our third 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. Mihael Polymeropoulos, our President, Chief Executive Officer and Chairman of the Board; and Tim Williams, our General Counsel. Following my introductory remarks, Mihael will update you on 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. Mihael Polymeropoulos.

Thank you very much, Kevin, and good afternoon, everyone. Thank you for joining us to discuss Vanda’s third quarter 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 I turn the call over to Kevin to discuss our overall progress and financial results. We have significantly advanced our development pipeline, now expecting FDA decisions on 2 supplemental NDAs for bipolar I disorder in adults and insomnia with PDUFA dates in the first half of 2024. Additionally, we expect the regulatory decision on our NDA for tradipitant in patients with gastroparesis by approximately mid-2024. We’re also pleased with our revenue performance despite the challenges of the at-risk launch of a generic HETLIO

Thank you, Mihaels. I’ll start with our HETLIO

Thank you, Tim. I’ll turn now to Kevin Moran to discuss our overall progress and financial results for this quarter. Kevin?

Thank you, Mihales. I’ll first discuss key regulatory and clinical updates before providing an update on our commercial progress and financial results. . Beginning with our upcoming regulatory milestones, we are now expecting FDA decisions on 2 supplemental new drug application filings in the first half of 2024. First, on Fanapt for bipolar I disorder. As previously discussed, in December of last year, we announced positive results in our Phase III clinical study of Fanapt in acute manic and mixed episodes with bipolar I disorder in adults. Our supplemental new drug application for Fanapt and bipolar I disorder in adults has now been accepted by the FDA, and the target action date has been set as April 2, 2024. We believe that this potential label expansion represents a significant opportunity for the Fanapt 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 approximately 3%, a number approximately up to 10x higher than the estimated prevalence of schizophrenia. On HETLIO

Thank you very much, Kevin. At this point, we will be happy to answer your questions.

Thank you all for joining us in this third quarter 2023 call, and we’ll see you in future periods. Thank you.