Core Points - Vanda Pharmaceuticals Inc. achieved a significant legal victory against the FDA regarding the approval of HETLIOZ® (tasimelteon) for treating jet lag disorder [1][4] - The U.S. Court of Appeals for the D.C. Circuit ruled that the FDA must engage meaningfully with the evidence presented by drug innovators like Vanda [4][6] - The court's decision mandates that the FDA either approve the supplemental New Drug Application (sNDA) or conduct a hearing on the matter [4][6] Company Summary - Vanda submitted its sNDA in October 2018, but the FDA delayed the resolution, leading to a federal court ruling that the FDA violated the Food, Drug, and Cosmetic Act [2][3] - The court found that Vanda provided substantial evidence of tasimelteon's efficacy in improving sleep disturbances, with trials showing statistically significant improvements [4][5] - Vanda has invested over a decade in clinical studies to develop HETLIOZ®, which has the potential to significantly benefit individuals suffering from jet lag [5][6] Industry Impact - The court's ruling alters the relationship between the FDA and pharmaceutical companies, emphasizing the need for the FDA to fairly evaluate scientific evidence [6][7] - This decision may encourage other drug manufacturers to challenge FDA decisions that they believe are unjust, potentially leading to more innovative therapeutics reaching the market [7]

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]

Vanda, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $52.59 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 4.38%. This compares to year-ago revenues of $50.47 million. The company has topped consensus revenue estimates three times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commenta ...

Financial Data and Key Metrics Changes - Total revenues for Q2 2025 were $102.6 million, a 5% increase compared to $97.9 million for the same period in 2024, primarily driven by growth in Fanapt revenue due to the bipolar commercial launch [15][16] - Net loss for the first six months of 2025 was $56.7 million, compared to a net loss of $8.7 million for the same period in 2024, with operating expenses increasing to $182.2 million from $117.3 million [20][27] - Cash and cash equivalents as of June 30, 2025, were $325.6 million, a decrease of $49.1 million compared to December 31, 2024 [21] Business Line Data and Key Metrics Changes - Fanapt net product sales for the first six months of 2025 were $52.8 million, a 21% increase compared to $43.7 million in the same period in 2024, attributed to increased volume [16][22] - HETLIOZ net product sales were $37.1 million for the first six months of 2025, a 4% decrease compared to $38.8 million in the same period in 2024, due to a decrease in volume [16][19] - POMVORY net product sales were $12.7 million for the first six months of 2025, an 18% decrease compared to $15.4 million in the same period in 2024, attributed to a decrease in volume and price [19] Market Data and Key Metrics Changes - Fanapt revenue increased by 27% compared to the same period in the prior year, driven by the launch of the bipolar I indication, with total prescriptions increasing by approximately 24% compared to 2024 [7][22] - HETLIOZ continues to retain the majority of market share despite generic competition for over two and a half years [17] - POMVORY new patient prescriptions grew to a record high since the initiation of Vanda's commercial launch [30] Company Strategy and Development Direction - The company is focused on expanding its sales force and increasing prescriber awareness for Fanapt and POMVORY, with plans to grow the sales force to approximately 50 representatives for POMVORY [29][30] - Vanda is preparing for the potential launch of Bisanti, with commercial product preparedness expected by the end of Q2 2026 [38] - The company aims to achieve total revenue from Fanapt, HETLIOZ, and POMVORY of between $210 million and $250 million by year-end 2025, indicating significant growth potential [33] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing commercial efforts for Fanapt and POMVORY, noting significant growth indicators and a strong market response [28][29] - The company anticipates variability in HETLIOZ revenue due to continued generic competition and inventory stocking changes at specialty pharmacy customers [18][19] - Management highlighted the importance of ongoing investments in R&D and commercial strategies to facilitate future revenue growth [34] Other Important Information - The NDA for Bisanti for the acute treatment of bipolar I disorder was accepted for filing by the FDA, with a PDUFA target action date of February 21, 2026 [9][10] - The company is also pursuing regulatory updates for Tradipitant, with a target filing date for motion sickness set for December 30, 2025 [11][52] Q&A Session Summary Question: Outlook for Bisanti commercialization - Management expects to be ready for launch by the end of Q2 2026 if approved, with minimal additional commercial operation spend needed [38] Question: Nature of dispute related to POMVORY - The dispute relates to a gross to net item, with approximately $3 million recognized for the three months ended December 31, 2024, under dispute [42] Question: Progress on Tradipitant - Tradipitant for motion sickness is under review, with potential market entry as early as January 1, 2026, if approved [52] Question: Interactions with the FDA regarding Bisanti - Regulatory review is ongoing with no major issues reported, and the company is encouraged by the progress [58] Question: Margins and Medicaid impact for Bisanti - Medicaid typically accounts for 30% to 40% of unit volume, with significant rebates impacting net revenue calculations [60][62]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 (Exact name of registrant as specified in its charter) Delaware 03-0491827 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 2200 Pennsylvania Avenue NW, Suite 300E Washington, DC 20037 (202) 734-3400 (Registrant's t ...

Exhibit 99.1 Vanda Pharmaceuticals Reports Second Quarter 2025 Financial Results WASHINGTON – July 31, 2025 – Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the second quarter ended June 30, 2025. "We have witnessed accelerated growth of Fanapt revenue coinciding with the expansion of our sales efforts alongside a broad direct to consumer brand awareness campaign and we expect this trend to continue in the coming quarters," said Mihael H. Polymeropoul ...

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]

Company Announcement - Vanda Pharmaceuticals Inc. will release its second quarter 2025 results on July 31, 2025, before the market opens [1] - A conference call will be held at 8:00 AM ET on the same day to discuss the financial results and corporate activities [2] - The conference call will be available for live broadcast and archived on Vanda's website [3] Replay Information - A replay of the conference call will be accessible starting at 11:00 AM ET on July 31, 2025, until August 7, 2025, at 11:59 PM ET [4] - Specific call-in numbers for domestic and international callers are provided for the replay [4] Company Overview - Vanda Pharmaceuticals is a global biopharmaceutical company focused on developing innovative therapies to meet high unmet medical needs [5]

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]

Company Overview - Vanda Pharmaceuticals Inc. is a leading global biopharmaceutical company focused on developing and commercializing innovative therapies to address high unmet medical needs and improve patient lives [2]. Upcoming Events - The company will participate in investor meetings at the Mizuho Neuro & Ophthalmology Summit 2025 in New York City on May 21, 2025 [1].