Vanda Pharmaceuticals Inc.

Hello and thank you for standing by. My name is Mark and I will be your conference operator today. At this time, I would like to welcome everyone to the Q3 2025 Vanta Pharmaceuticals 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. And to withdraw your question, press star one again. Now I would like to turn the call over to Kevin Moran. Vandas Chief Financial Officer, please go ahead.

Thank you, Mark. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceutical's third quarter 2025 performance. Our third quarter 2025 results were released this afternoon and are available on the SEC's editor 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 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 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. Mahalis Pai-Moravlis.

Mahalis Pai- Thank you very much, Kevin, and good afternoon, everyone. Thank you for joining us to discuss Vanda's third quarter 2025 results. This quarter reflects strong commercial execution with total net product sales reaching 56.3 million, up 18% year-over-year, led by a 31% increase in FNAP sales and 35% growth in prescriptions. Headless continues to deliver stable performance with $18 million in Q3 sales. We're particularly encouraged by our advanced pipeline with multiple near-term regulatory milestones. The Tredipitant NDA for motion sickness under FDA review with a PDUFA target action date of December 30, 2025. The Bisanti NDA for bipolar I disorder and schizophrenia also under FDA review with a PDUFA target action date of February 21, 2026. and the anticipated Q4 submission of the IMSI-Dolimab BLA for generalized postular psoriasis. We're also investing strategically in our commercial infrastructure, including increased brand visibility through targeted sponsorships with the goal of supporting long-term market leadership and future commercial launches. We believe that these milestones, combined with our collaborative framework with the FDA, will position Vanda for sustained growth and expanded therapeutic impact in 2026 and beyond. On commercial updates, during the third quarter, our FNAP sales force further expanded their efforts, and we continued our broad awareness campaigns. FNAP revenue increased by 31% compared to the same period in the prior year, driven by the launch of the Bipolar I indication. FNAP is now promoted in the U.S. across all 50 states, with a dedicated sales force of approximately 300 representatives. With the expansion of the sales force that was largely completed during the second quarter, we observed a significant increase in activity with a total number of calls growing by more than 20% as compared to the second quarter of 2025 and growing by over 100% compared to Q3 of 2024. Since the bipolar loans, demand is measured by total prescriptions, TRX, new prescriptions, NRX, and new-to-brand prescriptions and BRX reached new highs in the third quarter. The commercialization of FNAPT is also supported by a broad speakers program operating across the country that educates prescribers on the profile of FNAPT and how to use it. We're excited by the progress our commercial organization has made as we continue to support the commercialization of FNAPT, aiming for further growth in the coming periods. Total revenue from our three commercial branded products, FNAP, Hetlios, and Ponvori, reached $158.9 million in the first nine months of 2025. Hetlios continues to be the market share leader, despite the availability of three generic products, a testament to the brand loyalty of our patient customers over the last 11 years. We'll continue to build out in training of our dedicated Ponvori Salesforce team addressing prescribers for multiple sclerosis. In the last two quarters, we saw an increase in underlying base and demand as we intensified our consumer and prescriber awareness programs. During the first nine months of 2025, our direct-to-consumer campaign, launched in the first quarter, continued to drive meaningful gains in brand awareness for the company and our products, Phenapt and Ponvori. We maintained strategic investments in our commercial infrastructure, including increased brand visibility through target sponsorships with a goal of supporting long-term market leadership and future commercial launches. Key regulatory clinical updates. Collaborative framework for resolution of disputes with the FDA. On October 1, 2025, we announced a collaborative framework with the U.S. Food and Drug Administration for the resolution of certain disputes regarding Hetliers and tradipidant. Pursuant to the agreement, the FDA will conduct an expedited re-review of the partial clinical hold preventing long-term clinical studies of tradipidant for the treatment of motion sickness by November 26, 2025. The FDA will continue its review of ANDA's new drug application for this indication with the existing prescription drug user FIAC target action date of December 30, 2025. The FDA will conduct an expedited re-review of ANDA's supplemental new drug application, SNDA, for hetlios for the treatment of jet lag disorder by January 7, 2026, including consideration of alternative or narrowed indications focusing on the sleep-related aspects of jet lag disorder. BISANTE. The NDA for BISANTE for the acute treatment of bipolar I disorder and the treatment of schizophrenia is under review by the FDA with a PDUFA target action date of February 21, 2026. If approved, exclusivity for BISANTE, including pending patent applications, could extend in the 2040s. Bisanti is a new chemical entity which was initially identified as an active metabolite of alloperidone. Vander discovered that milsaperidone, when administered orally, quickly interconverts to alloperidone. In clinical studies, milsaperidone and alloperidone have been shown to be bioequivalent at both low and high doses administered both in single and multiple dose studies. The results of these clinical studies were presented in late May at the 2025 American Society of Clinical Psychopharmacology Annual Meeting in Scottsdale, Arizona. The Bisanti Phase III clinical study for use as once daily adjunctive treatment for major depressive disorder is ongoing and enrolling patients. Results are expected in 2026. we plan to randomize approximately 500 patients who do a clinical study across approximately 50 sites. And as the number of patients randomized increases, we'll be in a better place to estimate the time to completion. The NDA for tradipitin for motion sickness is under review by the FDA with a PDUFA target action date of December 30, 2025. In the fourth quarter of 2024, Then they initiate a clinical trial to study Tredipitin in the prevention of vomiting induced by GLP-1 analog, Wegovi, semaglutide. The trial is now complete and results are expected in the fourth quarter of 2025. Iloperidone long-acting injectable. The phase three study of the long-acting injectable formulation of Iloperidone in the treatment of schizophrenia and relapse prevention is ongoing and enrolling patients. We plan to randomize approximately 400 patients into the clinical study across approximately 60 sites. In general, we have seen similar clinical studies run by other organizations, and they take around two years to complete. As the number of patients randomized increases, we'll be in a better place to estimate completion of that study. A clinical study of the long-acting injectable formulation of allopuridone in people with treatment-resistant hypertension is now ongoing and Vanda plans to begin enrolling patients soon. Imcidolimab. A BLA for Imcidolimab in the treatment of the rare orphan disorder generalized postular psoriasis is expected to be submitted to the FDA in the fourth quarter of 2025. Punvori. Investigational new drug applications for Punvori in the treatments of psoriasis and ulcerative colitis were accepted by the FDA in the fourth quarter of 2024. Vanda has initiated the psoriasis study and plans to initiate the study in ulcerative colitis in early 2026. Early stage program highlights. VKW-765 and Alpha-7 Nicotinic Acetylcholine Receptor Parcel Agonist, is currently in clinical development for the treatment of acute performance anxiety in social situations. Vanda has initiated a phase three program and is enrolling patients. We plan to randomize approximately 500 patients into the clinical study across approximately 30 sites, and as the number of patients of randomization increases, again, we'll be able to estimate time to completion. The IND for VCA894A in the treatment of sarcoma retooth disease, axonal type 2S, or CMT2S, an inherited peripheral neuropathy for which there is no available treatment, was accepted by the FDA in 2024. Previously, in 2023, VCA894A was granted orphan drug designation for the same indication. The Phase I clinical study for VCA894A enrolled the patient who has already received several doses of VCA894A. With that, I'll turn now to Kevin to discuss our financial results. Kevin?