are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, the FDA's ability to complete its review of, and reach a decision with respect to, the imsidolimab BLA by December 12, 2026; Vanda's assumptions regarding how imsidolimab achieves its therapeutic effect; Vanda's ability to obtain FDA approval ...

Core Insights - Vanda Pharmaceuticals reported a strong financial performance for the full year 2025, with total revenues increasing by 9% to $216.1 million compared to 2024, driven primarily by a 24% increase in net product sales of Fanapt® [1][2] - The company is awaiting FDA approval for Bysanti™ (milsaperidone) for bipolar I disorder and schizophrenia, with a target action date of February 21, 2026, which could expand its psychiatry franchise [1][2] - The FDA approved NEREUS™ (tradipitant) for the prevention of motion-induced vomiting, marking a significant milestone as the first new oral therapy for this condition in over 40 years [1][2] Financial Highlights - For Q4 2025, Vanda reported a net loss of $141.2 million, compared to a net loss of $4.9 million in Q4 2024, with a diluted net loss per share of $2.39 [2][4] - The provision for income taxes in Q4 2025 was $103.2 million, influenced by a non-cash charge of $113.7 million against deferred tax assets [1][2] - Full year 2025 net loss was $220.5 million, compared to $18.9 million in 2024, with a diluted net loss per share of $3.74 [2][4] Operational Highlights - Fanapt® saw a 24% increase in net product sales for the full year 2025, totaling $117.3 million, supported by a 28% rise in total prescriptions [1][2] - The company launched a direct-to-consumer campaign in 2025, enhancing brand awareness for Fanapt® and PONVORY® [1][2] - Vanda is preparing for the commercial launch of NEREUS™ and plans to initiate a Phase III program for its use in preventing vomiting from GLP-1 analogs in the first half of 2026 [1][2] Regulatory & Clinical Development - Vanda received a decision letter from the FDA regarding the sNDA for HETLIOZ® for jet lag disorder, indicating it cannot be approved in its current form [2] - Ongoing clinical studies include a Phase III study of the long-acting injectable formulation of iloperidone for schizophrenia and a Phase III study of VQW-765 for social anxiety disorder [2] - The company submitted a BLA for imsidolimab for generalized pustular psoriasis in Q4 2025 [2] 2026 Financial Guidance - Vanda expects total revenues for 2026 to be between $230 million and $260 million, with Fanapt® net product sales projected to be between $150 million and $170 million [2]

Core Viewpoint - Vanda Pharmaceuticals has received FDA approval for NEREUS™ (tradipitant), marking the first new pharmacologic treatment for motion sickness in over 40 years, which is a significant advancement in managing this condition that affects a large portion of the population [1][2] Company Overview - Vanda Pharmaceuticals is a global biopharmaceutical company focused on developing innovative therapies to address unmet medical needs and improve patient lives [9] - The company is advancing tradipitant for additional indications, including gastroparesis and nausea/vomiting induced by GLP-1 receptor agonists [6][10] Product Details - NEREUS™ is an oral neurokinin-1 (NK-1) receptor antagonist approved for the prevention of vomiting induced by motion in adults [11] - The drug's mechanism of action involves potent and selective antagonism of NK-1 receptors, addressing the sensory conflict that triggers nausea and vomiting [5] Clinical Evidence - The efficacy of NEREUS™ is supported by data from three pivotal clinical trials, showing significant reductions in vomiting incidence: - In Motion Syros (n=365), vomiting incidence was 18.3–19.5% with NEREUS™ compared to 44.3% with placebo (p<0.0001) - In Motion Serifos (n=316), vomiting rates were 10.4–18.3% with NEREUS™ versus 37.7% with placebo (p=0.0014), indicating risk reductions of over 50–70% [3] Market Context - Motion sickness affects approximately 25–30% of adults in the U.S., equating to roughly 65–78 million people, with up to one-third of individuals globally being highly susceptible [5] - A significant segment of the population experiences severe symptoms that can greatly impact quality of life, with tens of millions seeking pharmacologic treatment annually [5] Future Prospects - Vanda anticipates launching NEREUS™ in the coming months and is committed to expanding its therapeutic potential across indications driven by substance P-mediated pathways [7]