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8/5/2026
Good afternoon and welcome to the second quarter 2026 Vanda Pharmaceuticals Inc. earnings conference call. I am Franz and I'll be the operator assisting you today. 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 1 on your telephone keypad. If you would like to withdraw your question, please press star 1 again. Thank you. I would now like to turn the call over to Vandes Chief Financial Officer, Kevin Moran. Please go ahead.
Thank you, France. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceuticals' second quarter 2026 performance. Our second 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 and many more. 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.
Good afternoon, everyone. Thank you for joining us today for Vanda Pharmaceuticals' second quarter 2026 earnings conference call. We're pleased with the continuous strong growth of Phenapt and the enthusiastic response to Inirius as it becomes available to patients. With Bisanti approved and on track for launch in the second half of 2026, a December 2026 PDUFA date for Quimilza or MC-Dolima, and multiple late-stage clinical trial results expected before year-end, We believe Vanda is well positioned for meaningful commercial expansion and pipeline value creation. As our Phase 3 programs launch preparations and commercial supply manufacturing near completion, we expect operating expenses to begin moderating later this year and more significantly in 2027. We believe that our current resources, together with anticipated product revenues, provide a solid foundation to advance our objectives through at least the end of 2027. During 2025 and 2026, we have advanced multiple Phase III programs and continued execution on the commercialization of Fanaft and Punbori and prepared for the commercial launches, including manufacturing, commercial supplies of Nereus, Bisanti, and Quimilza. As these activities conclude, we expect operating expense to begin decreasing by end of 2026 and more substantially through 2027. Based on our current cash position and anticipated revenues, we expect to have sufficient resources to fund operations through at least the end of 2027. FNAF show continued strong momentum in the second quarter of 2026, with total prescriptions, TRX, up 31%, and new-to-brand prescriptions, NBRX, up 32% versus the second quarter of 2025. Since commercial expansion following the approval of bipolar 1 disorder, Phenaptia has seen significant growth with TRX up 62%, NBRX up 300% versus the second quarter of 2024. Bisanti received U.S. Food and Drug Administration approval for the treatment of bipolar 1 disorder and schizophrenia in the first quarter of 2026 and is expected to launch in the second half of 2026. Bisanti is protected by data exclusivity through February 20, 2031 and multiple patents, the latest of which expires on May 31, 2044. In May 2026, the early commercial launch of Nereus was initiated with a direct-to-consumer offering via the web portal Nereus.us. Personal promotion is expected to commence later in 2026. Vandes' ongoing late-stage clinical studies are progressing rapidly and are expected to generate top-line results in 2026 or early 2027, including the phase three study of Nereus for the prevention of vomiting in patients receiving GLP-1 receptor agonist therapies with results expected in 2026. The phase three study of VQW-765 in the treatment of adults with social anxiety disorder with results expected in 2026. The phase three study of Hetlios in the treatment of delayed sleep phase disorder, DSPD, with results expected in 2026. Finally, the Phase III study of Bisanti as a once daily adjunctive treatment for major depressive disorder with results expected in the first half of 2027. The Biologic License Application, BLA, for Quimilza in generalized postular psoriasis is under review by the FDA with the Prescription Drug User Fee Act, target action date of December 12, 2026. The results of the pivotal clinical study were published earlier in April 28, 2026 in the New England Journal of Medicine Evidence. In May 2026, we announced that Japan's Ministry of Health, Labor, and Welfare granted orphan drug designation to Quimilza for the treatment of GPP. In July 2026, we announced that the Committee for Orphan Medicinal Products at the European Medicines Agency had adopted a positive opinion recommending orphan drug designation for Quimilza for the treatment of GPP. In July 2026, we announced that the FDA had granted Rare Pediatric Disease Designation for VCA894A, our Investigational Antisense Oligonucleotide Therapy for the Treatment of Charcot-Marie-Tooth Disease, Axonal Type 2S, or CMT2S, a Rare, Serious, and Progressive Inherited Neurological Disorder. We continue to progress the FDA formal hearing regarding Hetlios for the treatment of jet lag disorder. The proceeding, a rare administrative hearing process, granted after the district 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 in December of 2026. With that, I'll turn now to Kevin to discuss our financial results. Kevin.
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