Vanda Pharmaceuticals Inc.

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 Pharmaceutical 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 withdraw your question, again, press the star 1. 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. 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 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 in 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 BANDIS 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 two supplemental NDAs for bipolar I disorder in adults and insomnia, with PDUFA dates in the first half of 2024. Additionally, we expect a 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 headless product. Over the course of this year, we have taken a number of actions to position the commercial business for continued success, both on existing products and indications, as well as potential future products and indications. This includes preparations for the potential near-term expansion of the FNAF franchise if we receive FDA approval for bipolar 1 disorder in adults. Finally, we look forward to increasing and diversifying our future revenue sources, both with these new products and new indications, on existing products and also potentially with external business development activities. With that, I will now ask Tim Williams, General Counsel, to provide a brief update on litigation matters. Tim.