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]

2026 CORPORATE PRESENTATION January 2026 PHARMACEUTICALS INC. Various statements in this presentation, including, but not limited to, the guidance provided under "2025 Financial Guidance" and statements regarding Vanda's commercial products, plans, priorities and opportunities, as well as statements about Vanda's strategic focus and its products in development and the related clinical development and regulatory timelines and commercial and therapeutic potential for such products, are "forward-looking statem ...

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]