Vanda Reiterates 2026 Revenue Guidance After Fanapt Sales
Second-quarter total net product sales were $50.5 million, excluding about $7.0 million of HETLIOZ orders to be booked in the third quarter.
Vanda Pharmaceuticals Inc. (VNDA) reiterated full-year 2026 total revenue guidance of $240 million to $290 million after Fanapt net product sales reached $36.0 million in the second quarter, a 23% increase from a year earlier.
The biopharmaceutical company said the range it had raised in the first quarter now folds BYSANTI into a $150 million to $170 million Fanapt and BYSANTI net product sales objective, with NEREUS at $10 million to $30 million and other net product sales at $80 million to $90 million.
Fanapt growth had been accelerating through the prior two quarters. Sales were $29.6 million in the first quarter, up 26% year over year, and $33.2 million in the fourth quarter of 2025, up 25%. Total prescriptions rose 31% and new-to-brand prescriptions rose 32% versus the year-ago second quarter, after total prescriptions rose 32% and new-to-brand prescriptions rose 76% in the first quarter.
Total net product sales were $50.5 million, a 4% decrease from $52.6 million a year earlier. That figure excludes about $7.0 million of HETLIOZ revenue for orders shipped June 29, 2026, that arrived July 1 and will be recognized in the third quarter.
HETLIOZ net product sales were $5.6 million, down 66% year over year, after $15.9 million in the first quarter, down 24%, and $16.4 million in the fourth quarter of 2025, down 18%. PONVORY net product sales were $7.9 million, up 12%. NEREUS net product sales were $1.0 million after a U.S. commercial launch in the quarter through the direct-to-consumer portal nereus.us; there were no NEREUS sales a year earlier. Personal promotion is expected to commence later in 2026.
Loss before income taxes was $62.4 million, compared with $34.9 million a year earlier. Net loss was $62.5 million, or $1.04 a share, versus a net loss of $27.2 million, or $0.46 a share. The company said the pre-tax loss reflected continued investment in new product launches and pipeline advancement. Research and development expense was $37.0 million and selling, general and administrative expense was $71.8 million.
Cash, cash equivalents and marketable securities totaled $170.0 million as of June 30, 2026, a $32.3 million decrease in the quarter from $202.3 million at March 31. Vanda said current resources, together with anticipated product revenues, are expected to fund operations through at least the end of 2027.
BYSANTI (milsaperidone) received FDA approval for bipolar I disorder and schizophrenia in the first quarter and is expected to launch in the second half of 2026. The company said operating expenses are expected to begin moderating later this year and more significantly in 2027 as Phase III programs, launch preparations and commercial supply manufacturing near completion.
The biologics license application for Quimilza (imsidolimab) in generalized pustular psoriasis is under FDA review with a PDUFA target action date of December 12, 2026. Results of three Phase III trials are expected by the end of 2026: NEREUS in vomiting in patients receiving GLP-1 therapies, VQW-765 in social anxiety disorder, and HETLIOZ in delayed sleep phase disorder. A Phase III study of BYSANTI as a once-daily adjunctive treatment for major depressive disorder is expected in the first half of 2027.
President, CEO and Chairman Mihael H. Polymeropoulos said the company is well positioned for commercial expansion and pipeline value creation with BYSANTI on track for a second-half launch, a December PDUFA date for Quimilza, and multiple late-stage results expected before year-end.