Core Insights - Vanda Pharmaceuticals reported a GAAP net loss of $27.2 million for Q2 2025, attributed to increased operating costs despite a 4.0% rise in GAAP revenue to $52.6 million, which fell short of analyst expectations [1][2] Financial Performance - GAAP revenue for Q2 2025 was $52.6 million, a 4.2% increase from $50.5 million in Q2 2024, but below the estimate of $54.8 million [2] - EPS (GAAP) was ($0.46), a significant decline of 475% from ($0.08) in Q2 2024 [2] - Fanapt® net product sales increased by 26.3% to $29.3 million, while HETLIOZ® and PONVORY® saw declines of 13.4% and 17.4%, respectively [2][5][6] Product Overview - Vanda Pharmaceuticals focuses on therapies for neurological and rare disorders, with key products including Fanapt®, HETLIOZ®, and PONVORY® [3] - The company is investing in direct-to-consumer marketing for Fanapt® and exploring new indications to enhance its market position [4] Cost Structure - Selling, general, and administrative costs (SG&A) reached $64.6 million, a 63.5% increase from Q2 2024, driven by larger sales teams and marketing expenditures [7] - Research and development costs rose by 32% to $21.99 million, reflecting investments in pipeline projects [7] Cash Position - Vanda ended Q2 2025 with $325.6 million in cash and equivalents, a decrease of $15.4 million from the previous quarter [8] - The company anticipates finishing fiscal 2025 with cash between $280 million and $320 million [8] Pipeline Developments - Bysanti™ has a PDUFA target action date of February 21, 2026, and is currently undergoing a pivotal Phase III trial for major depressive disorder [9][10] - Regulatory submissions for Imsidolimab and ongoing expansions for Fanapt® are planned for 2025 [11][12] Future Outlook - Vanda expects total revenues for fiscal 2025 to be between $210 million and $250 million, with continued growth anticipated for Fanapt® [14] - The company has flagged potential revenue declines for HETLIOZ® and uncertainties for other products due to market competition [14]

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]