Oct 28, 2026 earnings call — Q3 2026 revenue, launches, and expense moderation
Q3 revenue rose to $69.8 million, driven by Fanapt growth and early NEREUS sales.
Revenue $0.1B (est $0.1B) · EPS $-0.37 (est $-0.68)
Key quotes
"Fanapt net product sales were $38.8 million for the third quarter of 2026, a 24% increase compared to $31.2 million in the third quarter of 2025, and an 8% increase compared to $36 million in the second quarter of 2026."
"We intend to discuss the results with the FDA and plan to submit a supplemental new drug application, sNDA, seeking approval of NEREUS for the prevention of vomiting associated with GLP-1 receptor agonist therapy."
"As certain of these activities began concluding in the third quarter of 2026, operating expenses have decreased, and we expect operating expenses to decrease further in future quarters as the remainder of these activities conclude."
Analyst Q&A 5
Quimilza launch timing and other programs
Q (Ram Selvaraju · H.C. Wainwright): He asked how quickly Quimilza could launch if approved on December 12, the status of the BYSANTI MDD pivotal program, and for updates on the iloperidone long-acting injectable program. He also asked what might affect priority review for the tradipitant sNDA for GLP-1 nausea and vomiting.
A: Management said they are manufacturing commercial Quimilza supplies now and could have product ready a few months after December, with a goal to be on the market in the first half of 2027. The BYSANTI MDD study has been enrolling for about 18 months at over 50 sites, with more than 50% enrolled toward a 500-patient target and completion planned in the first half of 2027. For iloperidone LAI they said recruitment was slow and relapse rates were very small, and they are considering a pharmacokinetic bridging proposal to the FDA; on priority review for tradipitant they said it is hard to gauge but noted the large unmet need and strong effect sizes and that they will prepare the sNDA and meet with the FDA.
"That means that we could be ready with commercial product a few months after December." — Mihael Polymeropoulos (CEO·CHAIR)
Fanapt, BYSANTI timing, NEREUS refill data
Q (Les Sulewski · Oppenheimer): He asked about Fanapt new-to-brand prescription trends, what delayed BYSANTI commercial supply and whether product is in channel, refill rates and pills-per-fill for NEREUS, and why the GLP-1 phase III vomiting reduction was smaller than phase II and which data will support the sNDA filing.
A: Management said the lower NBRx growth in Q3 versus Q2 is expected as growth slows off a larger base, but year-over-year NBRx growth remains strong and market receptivity is high. They said BYSANTI timing depends on completion of commercial manufacturing supplies, with about 10 strengths almost ready and hope to launch in Q4. On NEREUS they said early launch fills show variability in pill counts and small but encouraging refill activity; regarding the GLP-1 studies they said the 27% versus 50% difference likely reflects variability and regression to the mean, placebo rates were similar at 58%, extreme vomiters showed similar large effects, and the sNDA will rest on the declared primary endpoint supported by phase II, pooled analysis, and a key secondary.
"The timing depends actually on completion of our commercial manufacturing supplies." — Mihael Polymeropoulos (CEO·CHAIR)
NEREUS use, label and revenue split
Q (Madison El-Saadi · B. Riley): She asked whether a GLP-1 label would limit NEREUS to the titration phase or allow chronic use, and whether the sNDA could support starting at the target GLP-1 dose. She also asked about the user profile of patients currently using NEREUS and whether the company will break out BYSANTI and Fanapt revenue and the expected Fanapt→BYSANTI transition by mid-2027.
A: Management said the studied regimen was short-term: dosing a few days before a semaglutide injection and seven days after, and they believe these data support prevention of GLP-1-induced vomiting rather than chronic use. They explained most vomiting happens on days one and two and beyond day three episodes are minimal, and their PK/PD analysis suggests the drug should work at lower GLP-1 doses as well. On users they expect targets to be patients starting, restarting, or titrating GLP-1s; Kevin said the company expects to break out BYSANTI and Fanapt revenue in disclosures and noted BYSANTI has more favorable gross-to-net economics than Fanapt; Mihael added the switch may be gradual and take three to four months to show measurable change after launch.
"This data, we believe supports the prevention of vomiting induced by GLP-1, period." — Mihael Polymeropoulos (CEO·CHAIR)
BYSANTI conversion pace and NEREUS pricing
Q (Olivia Saunders · Cantor Fitzgerald): She asked how quickly patients will convert from Fanapt to BYSANTI in 2027 and whether there are ways to accelerate the transition. She also asked about expected pricing and reimbursement approach for NEREUS if labeled for GLP-1 patients.
A: Management said the transition is a shift in company emphasis and will target both new patient starts and patients switching from other antipsychotics; many prescriptions are 90-day scripts so the switch will be gradual and may take three to four months to become measurable. Kevin noted there is a runway before Fanapt LOE late in 2027 to emphasize both products. On NEREUS pricing they said it is early, they currently price the motion sickness indication at a WAC of $255 with a 67% discount for cash paying customers under certain restrictions on nereus.us, and their pricing philosophy is to maximize access so people who need the drug can obtain it.
"We develop drugs so people who need them can have them." — Mihael Polymeropoulos (CEO·CHAIR)
BYSANTI MDD filing and Quimilza market
Q (Andrew Tsai · Jefferies): He asked if a successful MDD study in the first half of 2027 would be sufficient for filing or if another phase III would be run. He also asked about the patient population size and pricing power for Quimilza in generalized pustular psoriasis (GPP) and whether final labeling talks have started.
A: Management said they hope the MDD study will be positive and, based on the history with Fanapt and BYSANTI bioequivalence and about 18 years of evidence, they expect to file with one MDD study. On Quimilza and GPP they said it is an emerging market with increasing awareness, epidemiological surveys suggest there are several thousand patients in the U.S. with very few treated today, and they believe Quimilza offers a good solution to reduce acute flares and prevent subsequent flares; they also noted the IgG4 backbone predicts fewer anti-drug antibodies and they are formulating a launch plan and engaging key opinion leaders. Management did not state that final labeling discussions have been completed.
"On the MDD, we certainly hope that the study will be positive with a good and persuasive magnitude of response." — Mihael Polymeropoulos (CEO·CHAIR)