VNDA - NASDAQ

Good afternoon. My name is Abba 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. [Operator Instructions] After the speakers remarks, there will be a question-and-answer session. [Operator Instructions] 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 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. Additionally, we have Tim Williams, our General Counsel and Gunther Birznieks, our Senior Vice President of Business Development and R&D Committee Member. Following my introductory remarks, Mihael will update you on our ongoing activities. I will then comment on our financial results before opening 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 annual report on Form 10-K for the fiscal year ended December 31, 2021, 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 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 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, Kevin. And good afternoon, everyone. Thank you for joining us to discuss Vanda’s third quarter 2022 results. Over the last quarter, Vanda continue to focus on enhancing performance of its current commercial products, advancing clinical programs in 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. Patient Fanapt; our clinical program pipelines advancing with the recent completion of an enrollment in the Fanapt, 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 the end of this quarter. On to dividend preparation of the new drug application gastroparesis is ongoing, with FDA submission expected in the first half of 2023. The submission will include the results from to adequate and well controlled studies in patients with idiopathic and diabetic gastroparesis, which provides substantial evidence of effectiveness in the indication. If approved, through the Fanapt will 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 tradipitant in patients with gastroparesis is ongoing, which will provide further information on the safety and efficacy of tradipitant in gastroparesis. We recently presented the results of the pooled analysis from studies VLY-686-3301 and VLY-686-2301 which included a total of 342 patients, 175 on yield dividend, 1067 on placebo, which showed significant improvements in the clinical endpoints or change of nausea. Percent nausea free days and the gastroparesis core symptom improve in scale GC SI at week for treatment. In the sub-population, 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. Through dividends efficacy is also appreciated by patients who are participating in an expanded access program some already for over the years. Through dividends in motion sickness. On to dividend, we're also progressing with a clinical program in motion sickness, with a pivotal study currently ongoing and expected to be completed in the first half of 2023. HETLIO

Thank you, Mihael. I'd like to touch briefly on some key litigation activities. First, in intellectual property, that you probably know we had a trial last March in Delaware Federal Court, asserting a family of HETLIO

Thank you very much, Tim. I'll turn now to Kevin to discuss our commercial progress and financial results.

Thank you, Mihael. I’ll begin by summarizing our financial results for the first nine months of 2022, before turning to discuss the third quarter of 2022. Total revenues for the first nine months of 2022 were $189.9 million, a 5% decrease compared to $200.7 million for the same period in 2021. HETLIO

Thank you very much, Kevin, and Tim. At this point, we'll be happy to answer any questions we have.

[Operator Instructions] Your first question today comes from the line of Chris Howerton with Jefferies. Your line is now open.

Hi, this is Atrigger [ph] for Chris, can you go over what led to your decision to file on sNDA for HETLIO

First of all, just to clarify, we have not filed yet the sNDA. We plan to file this quarter. And yes, the chronic insomnia four-week study is the 2008 study. And the two additional studies in that will support this application are changing insomnia studies are phase advance that we have reported in the past.

Got it. Thank you.

There are no further questions at this time, I would now like to turn the call back over to Vanda management for closing remarks.