Core Insights - Vanda Pharmaceuticals reported a significant increase in Fanapt revenue, driven by expanded sales efforts and a direct-to-consumer brand awareness campaign, with expectations for continued growth in upcoming quarters [2][6] - The company anticipates important regulatory and clinical milestones that could enhance its commercial portfolio and advance its clinical pipeline [2] Financial Highlights - In Q2 2025, net product sales from Fanapt® reached $29.3 million, a 27% increase from $23.2 million in Q2 2024 [6][7] - Total net product sales from Fanapt®, HETLIOZ®, and PONVORY® were $52.6 million in Q2 2025, a 4% increase compared to $50.5 million in Q2 2024 [7] - The net loss for Q2 2025 was $27.2 million, compared to a net loss of $4.5 million in Q2 2024 [9] - Cash and cash equivalents stood at $325.6 million as of June 30, 2025, reflecting a decrease of $15.4 million from March 31, 2025 [7] Operational Highlights - Bysanti™ NDA for bipolar I disorder and schizophrenia is under FDA review with a PDUFA target action date of February 21, 2026 [6][8] - Tradipitant NDA for motion sickness is also under review, with a PDUFA target action date of December 30, 2025 [6][14] - Fanapt® experienced a 24% increase in total prescriptions (TRx) in Q2 2025 compared to Q2 2024 [7] Financial Guidance - Vanda expects total revenues for the full year 2025 to be between $210 million and $250 million, with year-end cash projected to be between $280 million and $320 million [11]

Group 1 - Vanda Pharmaceuticals Inc. will participate in the ASCP Annual Meeting from May 27 to May 30, 2025, presenting pharmacokinetic results of Milsaperidone and Iloperidone [1] - The presentation will include a poster titled "Pharmacokinetic Results of Single-Dose and Multiple-Dose Bioequivalence Studies of Milsaperidone and Iloperidone Immediate-Release Oral Tablets" [1] Group 2 - Bysanti™ is a new atypical antipsychotic drug that, if approved, could be available for sale in the US in 2026 [2] - Bysanti™ is expected to interact with various neurotransmitter receptors, including alpha-adrenergic, serotonin, and dopamine receptors [2] - Patent exclusivity for Bysanti™ could extend into the 2040s [2] Group 3 - Vanda Pharmaceuticals Inc. is focused on developing and commercializing innovative therapies to meet high unmet medical needs [3]

Core Viewpoint - Vanda Pharmaceuticals Inc. has filed a New Drug Application (NDA) for Bysanti™ (milsaperidone) with the FDA, which has set a target decision date of February 21, 2026, with no review issues identified at this time [1] Group 1: Product Development - Bysanti™ is a new chemical entity identified as an active metabolite of iloperidone, showing bioequivalence to iloperidone in clinical studies at both low and high doses [2] - The efficacy and safety of Bysanti™ for bipolar I manic and mixed episodes and schizophrenia are supported by clinical studies related to iloperidone, including two studies in acute schizophrenia episodes and one in bipolar I disorder [4] - Bysanti™ is currently being studied as a once-a-day adjunctive treatment for major depressive disorder (MDD) in patients with inadequate response to current treatments, with results expected in 2026 [5] Group 2: Market Potential and Exclusivity - If approved, Bysanti™ could be available for sale in the U.S. in 2026 and is eligible for 5 years of regulatory data exclusivity [5] - Current patent applications related to Bysanti™ could extend exclusivity into the 2040s [5][8] Group 3: Mechanism of Action - Bysanti™ belongs to the class of atypical antipsychotics, interacting with various neurotransmitter receptors, including alpha-adrenergic, serotonin, and dopamine receptors, which are believed to explain its therapeutic effects [6][8] - The discovery of bioequivalence to iloperidone allows for efficient development and exploration of additional therapeutic applications for Bysanti™ [7]