WASHINGTON, June 10, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the first dose in the first-in-human clinical trial to evaluate the safety and tolerability of VCA-894A, an antisense oligonucleotide (ASO) therapeutic, for a patient with a rare variant in the IGHMBP2 gene causing Charcot-Marie-Tooth disease Type 2S (CMT2S). VCA-894A is being developed for a patient who was first diagnosed at the age of 5 with a rare subtype of CMT disease known as CMT2S.1 CMT2S is a ...

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]

Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $50 million, a 5% increase from $47.5 million in Q1 2024, primarily due to growth in Fanapt revenue from the bipolar commercial launch [18][19] - Net loss for Q1 2025 was $29.5 million, compared to a net loss of $4.1 million in Q1 2024, reflecting increased expenses related to commercial activities and a $15 million payment for a licensing agreement [23][24] - Operating expenses in Q1 2025 were $91.1 million, up from $56.7 million in Q1 2024, driven by higher R&D and SG&A expenses [25] Business Line Data and Key Metrics Changes - Fanapt net product sales were $23.5 million in Q1 2025, a 14% increase from $20.6 million in Q1 2024, with total prescriptions increasing by approximately 14% [19][9] - HETLIOZ net product sales were $20.9 million in Q1 2025, a 4% increase from $20.1 million in Q1 2024, despite ongoing generic competition [20] - PONVORY net product sales were $5.6 million in Q1 2025, an 18% decrease from $6.8 million in Q1 2024, attributed to a decrease in volume [21] Market Data and Key Metrics Changes - Fanapt reached a milestone of 2,000 weekly prescriptions by the week of April 25, 2025, making it one of the fastest-growing atypical antipsychotics [9][26] - HETLIOZ continues to retain the largest market share despite generic competition for over two years [20] - The company expanded its psychiatry sales force to approximately 300 representatives, enhancing its market reach [27] Company Strategy and Development Direction - Vanda is in a new growth phase with multiple commercialized products and a robust pipeline, including recent NDA filings for Tradipitant and Vicente [7][8] - The company is focusing on expanding its commercial infrastructure and anticipates significant revenue growth from its product launches in 2025 and beyond [26][30] - Vanda expects to have six products commercially available by 2026, indicating a strong pipeline and market potential [29][30] Management's Comments on Operating Environment and Future Outlook - Management highlighted the strong market response to the commercial launch of Fanapt, with significant increases in new patient starts and total prescriptions [26][27] - The company anticipates variability in HETLIOZ revenue due to ongoing generic competition and inventory stocking changes [20][30] - Management reiterated its revenue guidance for 2025, expecting total revenues from key products to be between $210 million and $250 million, reflecting a growth of 626% compared to 2024 [30][31] Other Important Information - The company has initiated direct-to-consumer campaigns for both Fanapt and PONVORY, receiving positive feedback and increasing brand awareness [46] - Vanda is actively working through D120 questions from the EMA regarding its marketing applications for Fanapt and HETLIOZ [51] Q&A Session Summary Question: What kind of placebo adjusted change on MADRS or HAM D would be desired for a competitive profile for milseperidone? - Management indicated that they have not prespecified the margin, noting variability in major depression studies [35] Question: Can you provide details on the Phase III social anxiety study design? - Management stated that the study is set to begin in Q3 and referred to previously conducted studies for design details [36] Question: What is the latest strategy for tradipitant for gastroparesis? - Management explained the complexity of the FDA review process and that a new filing is not required at this time [39][41] Question: How long will the direct-to-consumer campaign run and how is its effectiveness measured? - Management confirmed the campaign's focus on bipolar disorder and PONVORY, noting positive feedback and increased awareness [45][46] Question: What is the market opportunity for Bisanti in major depressive disorder? - Management acknowledged that Bisanti would compete directly with CAPLYTA, emphasizing its once-daily dosing advantage [58] Question: When might the long-acting injectable formulations of Bisanti enter the clinic? - Management indicated that the long-acting injectable for Fanapt is initiating Phase III studies, while Bisanti is still in the formulation phase [61]

Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $50 million, a 5% increase from $47.5 million in Q1 2024, primarily due to growth in Fanapt revenue from the bipolar commercial launch [18][19] - Net loss for Q1 2025 was $29.5 million, compared to a net loss of $4.1 million in Q1 2024, reflecting increased expenses related to commercial activities and a $15 million payment for a global license agreement [24][25] - Operating expenses in Q1 2025 were $91.1 million, up from $56.7 million in Q1 2024, driven by higher R&D and SG&A expenses [25][26] Business Line Data and Key Metrics Changes - Fanapt net product sales were $23.5 million in Q1 2025, a 14% increase from $20.6 million in Q1 2024, with total prescriptions increasing by approximately 14% [20][21] - HETLIOZ net product sales were $20.9 million in Q1 2025, a 4% increase from $20.1 million in Q1 2024, despite ongoing generic competition [21][22] - PONVORY net product sales were $5.6 million in Q1 2025, an 18% decrease from $6.8 million in Q1 2024, attributed to a decrease in volume [22][23] Market Data and Key Metrics Changes - Fanapt reached a milestone of 2,000 weekly prescriptions in the week of April 25, 2025, making it one of the fastest-growing atypical antipsychotics [9][28] - HETLIOZ continues to retain the largest market share despite generic competition for over two years [9][21] - The company is expanding its psychiatry sales force to approximately 300 representatives to enhance market reach [8][29] Company Strategy and Development Direction - Vanda is entering a new growth phase with multiple commercialized products and a rich innovative pipeline, including recent new drug application filings for Tradipitant and Vicente [7][8] - The company is focusing on expanding its commercial infrastructure and increasing prescriber awareness for its products, particularly Fanapt and PONVORY [28][29] - Vanda expects to have six products commercially available by 2026, including Fanapt and PONVORY, which are in the early stages of commercial launch [31][32] Management's Comments on Operating Environment and Future Outlook - Management highlighted the strong market response to the commercial launch of Fanapt, with significant growth indicators such as new patient starts increasing nearly threefold [28][29] - The company anticipates revenue growth in 2025, with total revenues expected to range between $210 million and $250 million, reflecting a 626% increase compared to 2024 [32][34] - Management noted potential variability in HETLIOZ revenue due to ongoing generic competition and inventory stocking changes at specialty pharmacies [21][34] Other Important Information - The company has initiated a direct-to-consumer campaign targeting bipolar disorder and PONVORY, receiving positive feedback and increasing brand awareness [50][51] - Vanda is actively working through the D120 questions received from the EMA regarding its filings for Fanapt and HETLIOZ [56][57] Q&A Session Summary Question: What kind of placebo adjusted change on MADRS or HAM D would be desired for a competitive profile for milseperidone? - Management indicated that they have not prespecified the margin, acknowledging variability in major depression studies [38] Question: Can you provide details on the Phase III study for social anxiety? - Management stated the study is set to begin in Q3 and referred to previously conducted studies for design details [39][40] Question: What is the latest strategy for Tradipitant for gastroparesis? - Management explained the complexity of the FDA review process and that a new filing is not required at this time [41][43] Question: How long will the direct-to-consumer campaign run and how is ROI measured? - Management confirmed the campaign is ongoing and has received good feedback, validating the promotional sensitivity of the bipolar disorder market [50][51] Question: What is the market opportunity in Europe for antipsychotics? - Management acknowledged the tough pricing and reimbursement environment in Europe but noted a good appetite for long-acting injectables [56][57]

Financial Performance - Total net product sales from Fanapt, HETLIOZ, and PONVORY were $50.0 million in Q1 2025, a 5% increase compared to $47.5 million in Q1 2024[7]. - Fanapt net product sales were $23.5 million in Q1 2025, a 14% increase compared to $20.6 million in Q1 2024[7]. - Total revenues for the three months ended March 31, 2025, were $50,041,000, an increase of 5.3% compared to $47,462,000 for the same period in 2024[29]. - Net product sales for Fanapt reached $23,545,000, up from $20,579,000, representing an increase of 9.5% year-over-year[29]. - HETLIOZ net product sales increased to $20,872,000 from $20,053,000, reflecting a growth of 4.1%[29]. - PONVORY net product sales decreased to $5,624,000 from $6,830,000, a decline of 17.6%[29]. Expenses and Losses - Net loss was $29.5 million in Q1 2025, compared to a net loss of $4.1 million in Q1 2024, reflecting increased expenses related to a $15.0 million license agreement[7][20]. - Total operating expenses rose significantly to $91,069,000, compared to $56,697,000, marking an increase of 60.7%[29]. - The net loss for the quarter was $29,494,000, compared to a net loss of $4,146,000 in the prior year, indicating a substantial increase in losses[29]. - Net loss per share, basic and diluted, was $(0.50), compared to $(0.07) for the same period in 2024[29]. Cash and Assets - Cash, cash equivalents, and marketable securities were $340.9 million as of March 31, 2025, a decrease of $33.7 million compared to December 31, 2024[7]. - Cash and cash equivalents as of March 31, 2025, were $111,796,000, an increase from $102,316,000 at the end of 2024[31]. - Total assets decreased to $631,936,000 from $656,204,000, reflecting a decline of 3.7%[31]. - Stockholders' equity decreased to $511,417,000 from $538,546,000, a reduction of 5.0%[31]. Future Expectations - Vanda expects total revenues for 2025 to be between $210 million and $250 million[21]. - The company anticipates year-end 2025 cash to be between $280 million and $320 million[21]. Workforce - Vanda's workforce has surpassed 400 employees, marking a 22-year high[3]. Regulatory Updates - Tradipitant NDA for motion sickness has a PDUFA target action date of December 30, 2025[13]. - Bysanti NDA for bipolar I disorder and schizophrenia has a PDUFA target action date of February 21, 2026[6].

Group 1 - Vanda Pharmaceuticals Inc. will release its first quarter 2025 financial results on May 7, 2025, after market close [1] - A conference call will be held on the same day at 4:30 PM ET 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] Group 2 - A replay of the conference call will be accessible starting at 8:30 PM ET on May 7, 2025, until May 14, 2025 [4] - Vanda Pharmaceuticals is focused on developing innovative therapies to meet high unmet medical needs [5]

Core Viewpoint - Vanda Pharmaceuticals Inc. is facing delays from the FDA regarding the hearing on the approvability of tradipitant for gastroparesis, with the FDA attributing the delay to recent staff reductions, which Vanda disputes as a valid excuse [1][2][3]. Group 1: FDA Delays and Accountability - The FDA has indicated that a reduction in force on April 1 is partially responsible for delaying the recommendation on Vanda's hearing request by at least six months [2]. - Commissioner Dr. Martin Makary has stated that the cuts did not affect scientists or reviewers, raising questions about the validity of the FDA's claims regarding the delay [2][3]. - Vanda argues that the FDA has a history of denying hearing requests for new drug approvability over the past decade, suggesting systemic issues within the agency [3][4]. Group 2: Calls for Change - Vanda urges Commissioner Makary to intervene and restore legal adherence at the FDA, asserting that the culture of delay is not due to targeted reductions in force [5]. - The company emphasizes the need for "radical transparency and common sense" in the FDA's operations, as stated by both Commissioner Makary and Secretary Kennedy [5]. - Vanda's leadership calls for the FDA and DOJ to stop obstructing innovation and to focus on improving decision-making processes [6]. Group 3: Company Overview - Vanda Pharmaceuticals Inc. is a global biopharmaceutical company dedicated to developing innovative therapies to meet significant medical needs and enhance patient lives [7].