Vanda Pharmaceuticals NASDAQ: VNDA reported second-quarter 2026 revenue of $50.5 million, down 4% from a year earlier, as growth in Fanapt and PONVORY was offset by lower HETLIOZ sales amid generic competition and shipment timing. The company reiterated its full-year revenue outlook and said it expects operating expenses to begin declining late this year, with more substantial reductions anticipated in 2027.
Chief Executive Officer Mihael Polymeropoulos said the company was encouraged by continued growth for Fanapt and the initial availability of NEREUS. He also pointed to the planned second-half launch of BYSANTI, an FDA decision expected in December for Quimilza, and several anticipated late-stage clinical readouts as drivers of potential commercial expansion.
Fanapt Growth Offsets HETLIOZ Pressure
Fanapt net product sales rose 23% year over year to $36 million in the second quarter and increased 22% sequentially from $29.6 million in the first quarter. The sales growth was primarily driven by volume, according to Chief Financial Officer Kevin Moran.
Total Fanapt prescriptions increased 31% from the second quarter of 2025 and 11% from the first quarter, while new-to-brand prescriptions rose 32% year over year and 10% sequentially. Moran said a weekly Fanapt prescription count exceeded 2,700 in May, representing an 11-year high.
The company said Fanapt’s commercial expansion following its bipolar I disorder approval has supported substantial prescription growth since the second quarter of 2024. Total prescriptions were up 62% over that period, while new-to-brand prescriptions increased 300%.
HETLIOZ net product sales, however, fell 66% year over year to $5.6 million in the quarter and declined 65% from the first quarter. Vanda attributed the decrease to lower volumes stemming from U.S. generic competition, as well as shipment timing and inventory destocking by specialty pharmacy customers.
The company said second-quarter HETLIOZ revenue did not include approximately $7 million from orders shipped June 29 that arrived July 1. That revenue is expected to be recognized in the third quarter. Despite generic competition, Moran said HETLIOZ remained the leading product by market share.
PONVORY net product sales increased 12% from a year earlier and 27% sequentially to $7.9 million. NEREUS, which became commercially available in the U.S. in May, generated $1 million in second-quarter net product sales.
NEREUS Launch and BYSANTI Preparation
Vanda initiated the NEREUS launch through a direct-to-consumer web portal, nereus.us, and plans to begin personal promotion later in 2026. The company said it will use some portion of its approximately 300-representative Fanapt and BYSANTI sales force and its roughly 50-person PONVORY sales force to support NEREUS promotion, though the final structure has not been determined.
Wholesalers initially stocked $15.2 million of NEREUS during the quarter. Vanda recognized $1 million in revenue and constrained $12.6 million because of uncertainty surrounding patient demand, potential product returns, and elevated wholesaler inventory levels.
In response to an analyst question, Moran said investors should monitor physician engagement, patient acquisition, refills and pills per fill as the company develops more launch data. He described NEREUS as still being in an early launch phase.
BYSANTI received FDA approval during the first quarter for bipolar I disorder and schizophrenia and is expected to launch during the second half of 2026. Polymeropoulos said the product has data exclusivity through Feb. 20, 2031, along with patents extending as late as May 2044.
Pipeline Readouts and Regulatory Milestones
Vanda expects multiple phase III results in 2026 or early 2027, including studies of NEREUS for prevention of vomiting in patients receiving GLP-1 receptor agonists, VQW-765 for social anxiety disorder, and HETLIOZ for delayed sleep phase disorder. A phase III study of BYSANTI as an adjunctive treatment for major depressive disorder is expected to report results in the first half of 2027.
Polymeropoulos said the ongoing NEREUS GLP-1 study is designed to confirm findings from a prior study. In that earlier trial, which administered Wegovy at a 1-milligram dose without titration, approximately 60% of placebo-treated participants vomited, compared with roughly 30% of those receiving NEREUS, he said. The company believes the evidence could support a supplemental new drug application, pending trial results and continued FDA discussions.
The FDA is reviewing the biologics license application for Quimilza, or imsidolimab, in generalized pustular psoriasis, with a target action date of Dec. 12, 2026. The company also said Japan granted orphan drug designation for Quimilza in May, while the European Medicines Agency’s orphan-drug committee issued a positive designation opinion in July.
Vanda expects an administrative hearing concerning HETLIOZ for jet lag disorder to take place over five days in December 2026. General Counsel Daniel McGuire said the company was confident in presenting its case but declined to speculate on the outcome, adding that Vanda hopes for a favorable recommendation from the administrative law judge in early 2027.
Loss Widens as Spending Rises
Vanda reported a second-quarter net loss of $62.5 million, compared with a loss of $27.2 million a year earlier. Operating expenses increased to $114.3 million from $91.1 million, driven by higher research and development spending on VQW-765 and NEREUS, as well as selling, general and administrative spending for Fanapt, PONVORY, the NEREUS launch and the upcoming BYSANTI launch.
For the first six months of 2026, revenue was essentially flat at $102.2 million, while the net loss widened to $111.1 million from $56.7 million in the prior-year period. Cash, cash equivalents and marketable securities totaled $170 million as of June 30, down $93.8 million from year-end 2025.
Management said the increased spending reflects late-stage trials, commercial-launch preparation and production of commercial supply. As those activities conclude, the company expects expenses to begin decreasing by the end of 2026 and to decline more substantially during 2027. Vanda said its current cash position and anticipated product revenue should fund operations through at least the end of 2027.
The company reiterated 2026 total revenue guidance of $240 million to $290 million, including projected Fanapt and BYSANTI sales of $150 million to $170 million and NEREUS sales of $10 million to $30 million. Vanda did not provide cash guidance but said 2026 cash burn is likely to exceed its 2025 level.
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.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to contact@marketbeat.com.
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