Vanda Pharmaceuticals (NASDAQ:VNDA) highlighted strong growth for its lead product Fanapt and detailed several late-stage regulatory and clinical milestones during its fourth-quarter and full-year 2025 earnings call, while also reporting a sharply wider net loss driven largely by a one-time, non-cash tax charge.
Fanapt growth offset by Hetlioz pressure from generics
Chief Executive Officer Dr. Mihael Polymeropoulos said 2025 featured “strong commercial execution,” led by Fanapt. For the full year, Fanapt net product sales increased 24% to $117.3 million, supported by a 28% increase in total prescriptions and a 149% jump in new-to-brand prescriptions. Management attributed the performance to accelerating prescriber adoption and targeted commercial investments, including a direct-to-consumer campaign aimed at boosting brand awareness.
For Hetlioz, full-year net product sales fell 7% to $71.4 million. Moran said the decline reflected lower volume and price net of deductions amid continued U.S. generic competition, while noting the brand “continued to retain the majority of market share despite generic competition now for over three years.” Ponvory net product sales were $27.4 million, down 2% versus 2024, with the company also noting that certain variable consideration tied to Ponvory sales remains subject to dispute.
Quarterly results: higher revenue, but larger loss tied to tax valuation allowance
Fourth-quarter 2025 total revenues were $57.2 million, up 8% year-over-year and up 2% sequentially, primarily due to Fanapt growth. Fanapt fourth-quarter net product sales rose 25% to $33.2 million, with prescriptions up 36% year-over-year and new-to-brand prescriptions up 108%.
Hetlioz fourth-quarter net product sales declined 18% to $16.4 million, and Moran said results continue to be affected by pricing dynamics and inventory changes at specialty pharmacy customers. Ponvory fourth-quarter net product sales increased 17% to $7.6 million, driven by higher price net of deductions, partially offset by volume, while underlying patient demand increased modestly for the third consecutive quarter, according to management.
Vanda reported a net loss of $220.5 million for full-year 2025, compared with a net loss of $18.9 million in 2024. Moran said the 2025 results included $81.8 million of income tax expense, driven primarily by a one-time, non-cash income tax charge related to recording a valuation allowance of $113.7 million against deferred tax assets. The company also reported a fourth-quarter net loss of $141.2 million, including income tax expense of $103.2 million, again primarily tied to the valuation allowance.
Operating expenses increased to $367.3 million for 2025 from $239.4 million in 2024. Moran attributed the increase primarily to higher SG&A tied to commercial launches (Fanapt for bipolar I disorder and Ponvory for multiple sclerosis), preparation for future launches, and higher R&D expenses, including those related to the imsidolimab licensing deal with AnaptysBio and clinical development for Fanapt long-acting injectable and Bysanti in major depressive disorder.
Cash, cash equivalents, and marketable securities were $263.8 million as of Dec. 31, 2025, down $110.8 million from the prior year end. Moran said cash changes were driven by operating results (excluding the non-cash tax charge) and timing of working-capital items such as rebates and payments to vendors.
Pipeline and regulatory updates: Nereus approval, Bysanti and imsidolimab filings
Management emphasized a “major regulatory win” with the FDA’s late-2025 approval of Nereus (tradipitant) for the prevention of vomiting induced by motion. Polymeropoulos described it as the first new oral pharmacologic option in that space in more than 40 years, and said the company is preparing for launch. In the Q&A, executives said they expect commercial materials to be available “either by late Q2 or beginning of Q3.” The company has not disclosed pricing, though Moran cited market reference points, noting other NK-1 class products can range from $200 to $600 per dose and that Vanda expects a premium to products commonly used for motion sickness, such as Dramamine or scopolamine patches.
Vanda also discussed a potential label-expansion opportunity for tradipitant in vomiting associated with GLP-1 agonists. Polymeropoulos said the company plans to initiate a dedicated phase III program in the first half of 2026, while adding in Q&A that the study is being initiated and could produce results by late Q3 or Q4. He said the trial design will be similar to the prior study and will again use a 1 mg Wegovy challenge in Wegovy-naïve patients.
On Bysanti-iloperidone, the company said the NDA for bipolar I disorder and schizophrenia is under FDA review with a PDUFA target action date of Feb. 21, 2026. In response to an analyst question, management said it remains “optimistic for an on-time approval,” but added that commercialization—if approved—would likely wait until Q3 when commercial supplies are ready. Moran also said Vanda’s 2026 guidance does not include any revenue contribution from Bysanti, given the uncertain timing and launch considerations.
Vanda said it submitted the imsidolimab BLA in the fourth quarter of 2025 for generalized pustular psoriasis. In Q&A, management described GPP as a rare dermatological condition likely addressed with a small specialty sales force, noting increased awareness since the 2021 approval of spesolimab.
Commercial investments and guidance focused on currently marketed products
Management highlighted expanded commercial infrastructure, including growth in the Fanapt sales force from about 160 representatives at the end of 2024 to about 300 at the end of 2025, and the buildout of a roughly 50-representative specialty sales force for Ponvory. Moran said face-to-face calls in the fourth quarter of 2025 were more than double the level in the year-ago period.
For 2026, Vanda provided revenue guidance limited to currently commercialized products (Fanapt, Hetlioz, and Ponvory). The company expects total revenues from these products of $230 million to $260 million, including Fanapt net product sales of $150 million to $170 million and other net product sales of $80 million to $90 million. Moran said the guidance assumes continued decline in Hetlioz due to generic competition and modest growth for Ponvory, where the company is seeking improved market access.
Moran also said Vanda is not providing 2026 cash guidance, but expects 2026 cash burn to be greater than 2025. He noted a $10 million milestone payment to Eli Lilly expected in the first quarter of 2026 related to U.S. approval of Nereus, and said a potential $5 million milestone payment to AnaptysBio could be triggered if the imsidolimab BLA is approved.
Other clinical programs: LAI iloperidone and VQW-765
Vanda said a phase III study of Bysanti as a once-daily adjunct treatment for major depression is ongoing, with results expected by the end of the year. The company also said its long-acting injectable formulation of iloperidone continues enrolling patients in a phase III schizophrenia relapse-prevention study. In Q&A, management said enrollment progress has been slower than desired due in part to delays starting the study in Europe, and it did not provide clear visibility on whether enrollment goals will be reached by year-end.
In addition, Vanda said it initiated a phase III study of VQW-765 for social anxiety disorder, with results expected by the end of 2026, and noted ongoing clinical development programs for Ponvory in psoriasis and ulcerative colitis.
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.
