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5/6/2026
Thank you for standing by. My name is Jordan, and I'll be your conference operator today. At this time, I would like to welcome everyone to the Q1 2026 Vander 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'd like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you'd like to withdraw your question, press star one again. Thank you. I would now like to turn the call over to Vanda's Chief Financial Officer, Kevin Moran. Please go ahead.
Thank you, Jordan. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceuticals' first quarter 2026 performance. Our first quarter 2026 results were released this afternoon and are available on the SEC's EDGAR system and on our website, www.vandafarma.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. 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 Polymeropoulos.
Mahalis Polymeropoulos Thank you very much, Kevin. Good afternoon, everyone. Thank you for joining us today for Vanda Pharmaceuticals' first quarter 2026 earnings conference call. Vanda delivered strong commercial execution in the first quarter, highlighted by 26% year-over-year growth in FNAF sales, the groundbreaking U.S. launch of Nereus with its pioneering direct-to-consumer platform at nereus.us, and the FDA approval of Bisanti. We believe that these achievements, combined with meaningful pipeline progress and our RAISE 2026, revenue guidance positioned the company for continued growth and value creation. Financial highlights, the total net product sales reached 51.7 million in the first quarter of 2026, a 3% increase compared to 50 million in Q1 2025. FNAP net product sales were 29.6 million at 26% year-over-year. Full-year 2026 revenue guidance was raised to 240 to 290 million, including 10 to 30 million from newly launched Nereos. Key commercial highlights. FNAP saw continued strong momentum with total prescriptions, TRX, up 32%, and new-to-brand prescriptions, and BRX up 76% versus the first quarter of 2025. In April, 2026, weekly TRX for FNAPT reached an 11-year high of over 2,600 prescriptions for the week ending April 24, 2026. Nereus is now commercially available nationwide through nereus.us Vanda's innovative direct-to-consumer platform. This pioneering patient-centric model enables convenient ordering online with rapid direct delivery, eliminating traditional pharmacy barriers, and providing a seamless modern access experience. As the first new prescription therapy approved for the prevention of vomiting induced by motion in adults in more than 40 years, Nereus represents a breakthrough in both science and patient access. Some key regulatory and clinical development highlights. Bisanti received FDA approval for the treatment of bipolar I disorder and schizophrenia. Bisanti is protected by data exclusivity through February 20, 2031, and multiple patents, the latest of which expires on May 31, 2044. Vanda's ongoing late-stage clinical studies are progressing rapidly and are expected to generate top-line results in 2026 or early 2027, including the Phase III study of Bisanti as a once-daily adjunctive treatment for major depressive disorder, with results expected in Q1, 2027. The THETIS Phase III study of Nereus for the prevention of vomiting in patients receiving GLP-1 receptor agonist therapies with results expected in 2026. The Phase III study of VQW-765 in the treatment of adults with social anxiety disorder with results expected by the end of 2026. The FDA accepted the biologic license application for mcdolimab in generalized postural psoriasis with a prescription drug user PIAAC 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. 2026 is developing into a transformational year for Vanda with an extensive and diversified portfolio of commercialized products that include Fnapt, Hetlios, Hetlios LQ, Ponvori, Nereus, Bisanti, and potentially Imci Dolimab by year end. Our recent innovative launch of Nereus through the Nereus.us platform revolutionizes customer experience through a convenient ordering system at a significantly discounted cost-pay price. Finally, our late-stage pipeline with several late-stage Phase III studies are poised to further diversify our pipeline and strengthen Bandi's commercial presence for years to come. With that, I'll turn now to Kevin to discuss our financial results. Kevin.
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