Vanda Pharmaceuticals Inc.

Ladies and gentlemen, welcome to the Q3 2026 Vanda Pharmaceuticals Inc. earnings call. All lines have been placed on mute to prevent any background noise. And after the speaker's remarks, we will conduct a question and answer session. If you'd like to ask a question at that time, please press star then the number one on your telephone keypad to raise your hand and enter the queue. If you'd like to withdraw your question at any time, please press star 1 again. I'll now turn the call over to Vanda Chief Financial Officer, Kevin Moran.

Thanks, Colby. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceuticals' third quarter 2026 performance. Our third quarter 2026 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 Daniel McGuire, our General Counsel. Following my introductory remarks, Mihael will update you on our ongoing activities. I will then comment on our financial results before we open 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 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. Mihael Polymeropoulos.

Thank you, Kevin. Good afternoon, everyone. Thank you for joining us today for Vanda Pharmaceuticals' third quarter 2026 earnings conference call. We're pleased with the strong revenue growth in the third quarter, increasing 24% year over year, driven by continued FNAP momentum and the early contribution from our newest commercial launch, while operating expenses decreased 18% compared to the second quarter as key phase three and launch preparation activities conclude. Looking ahead with the commercial launch of Bisanti expected in fourth quarter, the Quimilsa BLA under FTA review with a December PDUFA date and positive phase three results Supporting Potential Expenses for Nereus in GLP-1 Induced Vomiting and Hetlius in Delayed Sleep-Wake Phase Disorder were focused on further moderating costs and driving revenue growth from our current portfolio and planned launches to support sustainable long-term value. Some of our financial highlights on operating expenses. During 2025 and 2026, We have advanced multiple Phase III programs, continued our commercial activities for Phenapt, Hetrius, and Pulvori, and prepared for the commercial launches including manufacturing, commercial supplies of Nereus, Bisanti, and Quimilza. These activities resulted in significantly increased operating expenses in 2025 and 2026. As certain of these activities began concluding in the third quarter of 2026, operating expenses have decreased, and we expect operating expenses to decrease further in future quarters as the remainder of these activities conclude. Some key commercial highlights. TNAPT saw continued strong momentum in Q3 2026 with total prescriptions, TRX, up 25%, and new-to-brand prescriptions, NBRX, up 18% versus Q3 2025. Since commercial expansion following the approval of bipolar disorder, FNAPT has seen significant growth with TRX up 72% and NBRX up 306% versus the second quarter of 2024. Bisanti received FDA approval for the treatment of bipolar 1 disorder and schizophrenia in the first quarter of this year, 2026, and is expected to launch in the fourth quarter of 2026. Bisanti is protected by data exclusivity through February 20, 2031, and multiple patents, the latest of which expires on May 31, 2044. NIRIS was launched commercially in the US in the second quarter of 2026, with a direct-to-consumer offering via the web portal Nereus.us. Salesforce promotion began in the third quarter of 2026. During the third quarter of 2026, the Nereus launch showed strong growth in both total prescriptions and unique prescribers as compared to the second quarter of 2026. Key regulatory and clinical developments. Recent and upcoming milestones. In October 2026, we announced positive results from the Phase III clinical study VPVLY 686-3601 of Nereus for the prevention of vomiting associated with GLP-1 receptor agonist therapy. We intend to discuss the results with the FDA and plan to submit a supplemental new drug application, SNDA, seeking approval of Nereus for the prevention of vomiting associated with GLP-1 receptor agonist therapy. In September of 2026, we announced positive top-line results from the pivotal Phase III study of hetlios in adults with delayed sleep-wake phase disorder. We intend to discuss this data with the FDA and to submit a supplemental NDA seeking approval of hetlios for DSW-PD. If approved, hetlios would be the first FDA-approved medicine indicated for this condition. The Biologics License Application, VLA, for Quimilza in Generalized Post-Sorority Psoriasis, or GPP, is under review by the FDA with a Prescription Drug User Fee Act, PDUFA, target, action date of December 12, 2026. The results of the pivotal clinical study were published in the April 28, 2026 issue of the New England Journal of Medicine Evidence. The Phase III study of DSANTE as a once-daily adjunctive treatment for major depressive disorder, MDD, is ongoing, with results expected in the first half of 2027. The study is enrolling patients in 54 sites in the U.S. and Europe and has enrolled 55% of the 500-patient enrollment target. The primary endpoint of the study is the change from baseline to week 6 of the Montgomery-Asperg Depression Rating Scale, MADRAS, comparing milsaperidone and placebo. Secondary endpoints include clinical global impression severity, CGIS, and clinical global impression change, CGIC. Finally, on ongoing regulatory proceedings, we continue to progress the FDA formal hearing for the treatment of jet lag disorder. The proceeding, a rare administrative hearing process granted after the circuit set aside the FDA's prior refusal to approve the application, is advancing according to schedule and is expected to culminate in a five-day hearing before the administrative law judge from December 14, 2026 to December 18, 2026. We continue to pursue our legal challenge to the FDA's final order refusing to hold a hearing or to approve our SNDA for head loss in the treatment of insomnia. Following oral argument before the U.S. Court of Appeals for the DC Circuit in September 2026, the matter is awaiting decision. We continue to pursue our challenge to the FDA's final order refusing to hold a hearing or to approve the company's NDA for Nereus in gastroparesis. Briefing is currently underway before the district circuit and is due to be completed in mid-November. With that, I'll turn now to Kevin to discuss our financial results. Kevin.