WASHINGTON, Aug. 21, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has asked Martin Makary, the Commissioner of the U.S. Food and Drug Administration (FDA) to review the decision made by Jacqueline Corrigan-Curay, the departing director of the FDA's Center for Drug Evaluation and Research (CDER), days before her retirement that upholds an Office of Generic Drugs decision to approve two generic versions of Hetlioz®.In 2023, Vanda filed citizen petitions challe ...

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].

Financial Performance - Total revenues for the three months ended March 31, 2025, were $50,041,000, an increase from $47,462,000 in the same period of 2024, representing a growth of 3.3%[15] - Net loss for the first quarter of 2025 was $29,494,000, compared to a net loss of $4,146,000 in the first quarter of 2024, indicating a significant increase in losses[15] - Comprehensive loss for the three months ended March 31, 2025, was $29,185,000, compared to a comprehensive loss of $4,499,000 in the same period of 2024[17] - For the three months ended March 31, 2025, Vanda Pharmaceuticals reported total net product sales of $50,041,000, an increase from $47,462,000 in the same period of 2024, representing a growth of 3.3%[32] - Total operating expenses for the same period were $91,069,000, a significant increase of 60.7% from $56,697,000 in the prior year[15] - The net loss for the three months ended March 31, 2025, was $29,494,000, compared to a net loss of $4,146,000 for the same period in 2024, indicating a substantial increase in losses[15] Expenses - Research and development expenses rose to $35,712,000 in Q1 2025, up from $21,154,000 in Q1 2024, reflecting a 68.7% increase[15] - Selling, general and administrative expenses increased to $50,084,000 in Q1 2025, compared to $30,085,000 in Q1 2024, marking a 66.6% rise[15] - Stock-based compensation expense for the three months ended March 31, 2025, totaled $2.97 million, down from $3.58 million in the same period in 2024, representing a decrease of 17.0%[67] Cash and Assets - Cash and cash equivalents as of March 31, 2025, were $111,796,000, up from $102,316,000 at the end of 2024, showing an increase of 9.5%[14] - Total assets decreased to $631,936,000 as of March 31, 2025, from $656,204,000 at the end of 2024, a decline of 3.7%[14] - Total cash provided by (used in) operating activities for the three months ended March 31, 2025, was $(33,147,000), compared to $7,569,000 in 2024, indicating a significant cash outflow[21] - The company’s total cash, cash equivalents, and restricted cash at the end of March 31, 2025, were $112,265,000, down from $125,627,000 at the end of March 31, 2024, a decrease of 10.7%[31] Product Sales - HETLIOZ net product sales for the three months ended March 31, 2025, were $20,872,000, slightly up from $20,053,000 in 2024, showing an increase of 4.1%[32] - Fanapt net product sales increased to $23,545,000 for the three months ended March 31, 2025, compared to $20,579,000 in 2024, marking a growth of 9.5%[32] - PONVORY net product sales decreased to $5,624,000 in the first quarter of 2025 from $6,830,000 in the same quarter of 2024, a decline of 17.6%[32] Legal Proceedings - The Company filed a lawsuit against the FDA in September 2023, challenging the approval of MSN's ANDA for its generic version of HETLIOZ capsules, claiming the approval data is faulty[78] - In December 2024, the Company filed a lawsuit against Teva and Apotex, asserting that their generic versions of HETLIOZ infringe U.S. Patent No. 11,918,556[79] - The Company has ongoing litigation regarding multiple patents related to HETLIOZ LQ, with a trial scheduled to begin on June 15, 2026[79] - The Company filed a lawsuit in May 2022 against the FDA for denying Fast Track designation for tradipitant, which was ruled against in August 2023[81] - The Company has a pending lawsuit against the FDA regarding its sNDA for HETLIOZ in the treatment of insomnia, with a hearing scheduled for May 2025[83] Shareholder Information - The weighted average shares outstanding for basic calculations increased to 58,527,775 in Q1 2025 from 57,760,940 in Q1 2024[15] - As of March 31, 2025, there are 7,846,424 shares subject to outstanding options and RSUs under the 2006 and 2016 Equity Incentive Plans[57] - The Company has $2.2 million of unrecognized compensation costs related to unvested service option awards expected to be recognized over a weighted average period of 0.8 years[60] Tax and Regulatory Matters - The company recorded an income tax benefit of $7.9 million for the three months ended March 31, 2025, compared to $0.5 million in 2024, indicating a significant increase in tax benefits[68] - The company maintained a valuation allowance against certain state net deferred tax assets, indicating ongoing assessments of deferred tax asset realizability[69] Market Strategy and Innovation - The Company has a diverse pipeline of products in development, including formulations for schizophrenia and various sleep disorders, indicating ongoing innovation and market expansion efforts[27] - The Company is actively pursuing market expansion and commercialization strategies for its products, including HETLIOZ and PONVORY, amidst competitive pressures[9] - The company is actively developing additional indications for its current products and has a pipeline of new drugs targeting various medical conditions[27]

Group 1 - Vanda Pharmaceuticals reported a quarterly loss of $0.50 per share, which was better than the Zacks Consensus Estimate of a loss of $0.55, and compared to a loss of $0.07 per share a year ago, indicating an earnings surprise of 9.09% [1] - The company posted revenues of $50.04 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 6.47%, and this represents an increase from year-ago revenues of $47.46 million [2] - Vanda has surpassed consensus EPS estimates three times over the last four quarters, indicating a positive trend in earnings performance [2] Group 2 - The stock has underperformed the market, losing about 8.8% since the beginning of the year, compared to the S&P 500's decline of 4.7% [3] - The current consensus EPS estimate for the coming quarter is -$0.18 on revenues of $55.25 million, and for the current fiscal year, it is -$1.12 on revenues of $225 million [7] - The Zacks Industry Rank for Medical - Biomedical and Genetics is currently in the top 35% of over 250 Zacks industries, suggesting a favorable industry outlook [8]