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The call conveyed a broadly positive commercial and pipeline momentum story: Fanapt demonstrated strong prescription growth and the company launched Nirius via a novel direct‑to‑consumer model while securing FDA approval for Dysanti and advancing imsidolimab toward potential year‑end regulatory action. Management raised 2026 revenue guidance and outlined multiple upcoming Phase 3 readouts that could be value drivers. Offsetting these positives are a materially larger Q1 net loss, increased operating expenses, a significant cash decline and ongoing Hetlioz erosion from generics, plus some development and recruitment risks for certain programs. Overall, commercial and regulatory catalysts appear to outweigh near‑term financial pressures.
Vanda raised full‑year 2026 total revenue guidance to $240–$290 million (vs. prior $230–$260M), explicitly including $10–$30 million from newly launched Nirius; the $265M midpoint implies roughly 23% revenue growth versus full‑year 2025. Fanapt guidance was reiterated at $150–$170 million (midpoint implies ~36% Fanapt growth vs. 2025), other net product sales were guided to $80–$90 million, and the company said these ranges assume consistent gross‑to‑net dynamics year‑over‑year. For Fanapt, the bottom end of the range assumes high single‑digit to low‑double‑digit sequential quarterly TRx growth for the remainder of 2026, while the top end assumes mid‑teens to high‑teens sequential TRx growth; Vanda did not provide 2026 cash guidance and cautioned 2026 cash burn will likely exceed 2025.
Q1 2026 total net product sales were $51.7M, up 3% year-over-year (Q1 2025: $50.0M). Vanda raised full-year 2026 revenue guidance to $240M–$290M (midpoint $265M), implying ~23% revenue growth vs full-year 2025.
Fanapt Q1 2026 net product sales were $29.6M, up 26% year-over-year (Q1 2025: $23.5M). Prescription metrics: TRx +32% YoY and NBRx +76% YoY. Weekly TRx reached an eleven‑year high of >2.6k for week ending 04/24/2026. Full-year Fanapt guidance $150M–$170M (midpoint implies ~36% growth vs 2025).
Nirius launched nationwide via a direct-to-consumer platform (nirius.us) with a cash-pay offering. Company introduced 2026 Nirius revenue guidance of $10M–$30M. WAC price set at $255 per capsule with cash-pay discounted to $85 (~65%+ discount). Described as first new prescription therapy for prevention of motion‑induced vomiting in adults in >40 years.
Dysanti (milsoperidone) received FDA approval for bipolar I disorder and schizophrenia; protected by data exclusivity through 02/20/2031 and patents through 05/31/2044. Company expects Dysanti commercial availability in back half of 2026.
FDA accepted the BLA for imsidolimab in generalized pustular psoriasis with a PDUFA target action date of 12/12/2026. Pivotal study results were published in NEJM Evidence (04/28/2026). Company is preparing commercial/regulatory activities in US, Europe, and Japan.
Several key Phase 3 timelines: Dysanti adjunctive MDD readout expected Q1 2027, a Phase 3 study of Nirius for GLP‑1 induced vomiting expected in 2026, and Phase 3 VQW‑765 (social anxiety) results expected by 2026 — signaling multiple upcoming value‑creating catalysts.
Fanapt sales force expanded from ~160 reps (end 2024) to ~300 reps (end 2025). Face‑to‑face calls in Q1 2026 were >80% higher vs Q1 2025, supporting continued prescription growth.
Thank you for standing by. My name is Jordan, and I will be your conference operator today. At this time, I would like to welcome everyone to the Q1 2026 Vanda Pharmaceuticals Inc. earnings conference call. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be a question-and-answer session. If you would like to ask a question during this time, please press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again.
Thank you. I would now like to turn the call over to Vanda Pharmaceuticals Inc.’s Chief Financial Officer, Kevin Moran. Please go ahead.
Thank you, Jordan. Good afternoon, and thank you for joining us to discuss Vanda Pharmaceuticals Inc.’s first quarter 2026 performance. Our Q1 2026 results were released this afternoon and are available on the SEC’s EDGAR system and on our website, vandapharma.com. In addition, we are providing live and archived versions of this conference call on our website. Joining me on today’s call is Mihael H. Polymeropoulos, our President, Chief Executive Officer, and Chairman of the Board. Following my introductory remarks, Mihael will update you on our ongoing activities. I will then comment on our financial results before we open the lines for your questions.
Before we proceed, I would like to remind everyone that various statements that we make on this call will be forward-looking statements within the meaning of federal securities laws. Our forward-looking statements are based upon current expectations and assumpt...