Vanda Pharmaceuticals NASDAQ: VNDA reported first-quarter 2026 revenue of $51.7 million, a 3% increase from $50.0 million in the prior-year period, as growth in Fanapt was partially offset by continued declines in HETLIOZ amid generic competition. Management also highlighted the U.S. commercial launch of NEREUS through a direct-to-consumer platform and the FDA approval of BYSANTI, alongside several late-stage pipeline milestones expected to read out over the next 12 to 18 months.
Commercial performance led by Fanapt growth
President, CEO, and Chairman Dr. Mihael Polymeropoulos said the quarter was marked by “strong commercial execution,” citing 26% year-over-year growth in Fanapt sales, the “groundbreaking U.S. launch of NEREUS,” and the FDA approval of BYSANTI (milsaperidone).
Chief Financial Officer Kevin Moran reported Fanapt net product sales of $29.6 million in Q1 2026, up 26% from $23.5 million in Q1 2025, but down 11% from $33.2 million in Q4 2025. Moran attributed the year-over-year increase primarily to higher volume, “partially offset by a decrease in price net of deductions.” The sequential decline versus Q4 was attributed to lower volume and lower price net of deductions, which he said reflected “insurance plan disruptions and deductible resets that are typical in the industry at the beginning of the year.”
Prescription metrics for Fanapt were also cited as key indicators of momentum:
- Q1 2026 total prescriptions (TRx) increased 32% year over year, according to IQVIA Exponent.
- New-to-brand prescriptions (NBRx) rose 76% year over year.
- Weekly TRx reached an 11-year high of more than 2,600 prescriptions for the week ending April 24, 2026, according to management.
On channel inventory, Moran said Fanapt inventory at wholesalers was “slightly above four weeks on hand” at quarter-end, generally consistent with Q4 2025 but slightly above historic levels. In response to an analyst question about potential destocking, Moran said he would not expect it if Fanapt continues to grow, noting that the weeks-on-hand calculation can lag when demand is increasing.
HETLIOZ pressured by generics; PONVORY mixed quarter
HETLIOZ net product sales were $15.9 million in Q1 2026, down 24% from $20.9 million in Q1 2025 and down 3% from $16.4 million in Q4 2025. Moran attributed the decline to reduced volume driven by “continued generic competition in the U.S.” He added that HETLIOZ sales can fluctuate due to inventory stocking patterns at specialty pharmacy customers and warned sales “may decline in future periods, potentially significantly,” as generic competition persists.
PONVORY net product sales were $6.2 million, up 10% from $5.6 million in Q1 2025 but down 18% from $7.6 million in Q4 2025. Moran said the year-over-year increase reflected higher volume and improved price net of deductions, while the sequential decline was primarily due to lower price net of deductions. He noted that underlying patient demand was “essentially flat” versus Q4 2025 despite typical early-year insurance disruptions.
NEREUS launch and pricing strategy
Management emphasized the nationwide availability of NEREUS via the company’s direct-to-consumer site, nereus.us. Polymeropoulos described the model as a “patient-centric” approach intended to “eliminate traditional pharmacy barriers” with online ordering and direct delivery. He said the company views motion sickness as “a prototypical consumer product,” offering the medication in increments of two capsules, which may align with travel needs.
Vanda raised full-year 2026 revenue guidance to include NEREUS for the first time, adding expected net product sales of $10 million to $30 million from the newly launched product. When asked about the breadth of that range, Polymeropoulos said it was “very early” and that the estimate was “more modeling” than experience-based. Moran similarly said the range is “not informed by actual data at this point,” but based on modeling and research; management expects to provide more context as the launch progresses.
On pricing, Moran said NK1 antagonists can range from “the $200 range up to about the $600 range” per dose, and that Vanda’s strategy is “in the middle on the lower end.” Polymeropoulos said the wholesale acquisition cost list price is $255 per capsule, while the cash-pay offering is “about a more than 65% discount,” which he quantified as $85 per capsule through the direct-to-consumer model. Management also indicated it plans to pursue broad access, including insurance coverage over time, while focusing initially on cash pay.
BYSANTI approval and launch timing; pipeline updates
Polymeropoulos said BYSANTI was approved by the FDA for the treatment of bipolar I disorder and schizophrenia, and that it is protected by data exclusivity through February 20, 2031, with patents “the latest of which expires on May 31st, 2044.” Moran said the company remains on track to have BYSANTI commercially available in the “back half of the year.” He added that demand for BYSANTI is expected to be “independent of Fanapt,” and that where BYSANTI replaces Fanapt use, the company expects “meaningful net price favorability,” implying a higher revenue contribution per unit.
In development, management pointed to several upcoming readouts and regulatory milestones:
- Thetis Phase III study of NEREUS (tradipitant) for prevention of vomiting in patients receiving GLP-1 receptor agonists, with results expected by the end of 2026. Polymeropoulos said the Phase III design is similar to a Phase II study that previously showed a “significant reduction in vomiting episodes,” but noted the short study will not directly answer adherence questions.
- Phase III study of VQW-765 in adults with social anxiety disorder, with results expected by the end of 2026.
- Phase III study of BYSANTI as a once-daily adjunctive treatment for major depressive disorder, with top-line results expected in Q1 2027. Polymeropoulos said the timing shifted from year-end 2026 due to updated recruitment projections and site additions, including in Europe.
- Imsidolimab BLA accepted by the FDA for generalized pustular psoriasis, with a PDUFA target action date of December 12, 2026. Polymeropoulos noted results from the pivotal study were published in the April 28, 2026 issue of New England Journal of Medicine Evidence.
Regarding imsidolimab commercialization, Polymeropoulos said Vanda does not expect to launch “right after the PDUFA date” due to the complexity of monoclonal antibody manufacturing and indicated the company hopes to launch “within the first half of 2027.” He also said the proposed indication supports both acute flare treatment and maintenance dosing in responders.
On a separate long-acting injectable iloperidone program in schizophrenia relapse prevention, Polymeropoulos said the study is recruiting slowly and that relapse rates on placebo appear to be declining across the field compared with prior years. He said Vanda plans to discuss the situation with the FDA and may modify the development plan.
Financial results, cash position, and updated 2026 guidance
Vanda posted a net loss of $48.6 million in Q1 2026, compared with a net loss of $29.5 million in Q1 2025. Operating expenses were $101.9 million, up from $91.1 million a year earlier. Moran attributed the increase primarily to higher SG&A spending tied to commercialization efforts for Fanapt and PONVORY, launch preparation for NEREUS and BYSANTI, and higher legal expenses, partially offset by lower R&D spending on imsidolimab.
Cash, cash equivalents, and marketable securities totaled $202.3 million as of March 31, 2026, down $61.5 million from December 31, 2025. Moran said the decline was driven by the quarterly net loss, a one-time $10 million milestone payment to Eli Lilly for NEREUS U.S. approval, seasonal compensation payments of about $7 million, and approximately $11 million of manufacturing payments. Excluding those items, he said the cash decline would have been “closer to $40 million.”
For 2026, the company raised total revenue guidance to $240 million to $290 million (from $230 million to $260 million previously), reflecting the potential contribution of NEREUS while maintaining prior ranges for Fanapt and other products. Specific guidance items included:
- Fanapt net product sales: $150 million to $170 million.
- Other net product sales (HETLIOZ and PONVORY): $80 million to $90 million, assuming further HETLIOZ decline and modest PONVORY growth.
- NEREUS net product sales: $10 million to $30 million.
Moran said the company is not providing 2026 cash guidance, but indicated it is “likely” cash burn will be higher than in 2025 due to ongoing investments.
About Vanda Pharmaceuticals NASDAQ: VNDA
Vanda Pharmaceuticals Inc is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for central nervous system (CNS) disorders and rare diseases. The company's research and development efforts center on sleep-wake regulation, mood disorders, and movement disorders. Vanda's mission is to address unmet medical needs by advancing novel molecules through clinical trials and regulatory review.
Vanda's flagship commercial product is Hetlioz (tasimelteon), a melatonin receptor agonist approved by the U.S.
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