Fanapt revenue growth of 24% was primarily driven by a 149% surge in new-to-brand prescriptions following the bipolar disorder commercial launch. Management attributes accelerating Fanapt momentum to targeted commercial investments, including direct-to-consumer campaigns and a sales force expansion to approximately 300 representatives. HETLIOZ revenue declined 7% due to generic competition, though the product has retained the majority of market share after three years of generic entry. The approval ...

Financial Data and Key Metrics Changes - Total revenues for the full year 2025 were $216.1 million, a 9% increase compared to $198.8 million for 2024 [18] - Net product sales for Fanapt were $117.3 million, a 24% increase from $94.3 million in 2024 [18] - The company recorded a net loss of $220.5 million for 2025, compared to a net loss of $18.9 million in 2024 [21] - Operating expenses for 2025 were $367.3 million, up from $239.4 million in 2024 [24] Business Line Data and Key Metrics Changes - Fanapt's total prescriptions increased by 28% in 2025 compared to 2024 [19] - HETLIOZ net product sales were $71.4 million for 2025, a 7% decrease from $76.7 million in 2024 due to generic competition [20] - Ponvory net product sales were $27.4 million for 2025, a 2% decrease from $27.8 million in 2024 [21] Market Data and Key Metrics Changes - The total addressable market for the antipsychotic category is estimated at approximately $20 billion in 2025 [7] - The long-acting injectable antipsychotic market is projected to be in the $6 billion-$7 billion range for 2025 [12] Company Strategy and Development Direction - The company plans to initiate a dedicated phase III program for Nereus in the first half of 2026, targeting the GLP-1 agonist market [7] - Vanda aims to strengthen its psychiatric franchise with the anticipated approval of Bysanti for bipolar I disorder and schizophrenia [17] - The company is focused on expanding its commercial infrastructure and brand visibility through targeted sponsorships and marketing programs [26][36] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the commercial launch of Nereus and the potential for significant market opportunities in motion sickness [6] - The company expects total revenues of $230 million-$260 million from current marketed products in 2026, indicating continued growth [40] - Management highlighted the importance of addressing unmet medical needs in major depressive disorder and social anxiety disorder through innovative therapies [10][12] Other Important Information - The company recorded a one-time, non-cash income tax charge of $113.7 million for the valuation allowance against deferred tax assets [22] - Cash, cash equivalents, and marketable securities as of December 31, 2025, were $263.8 million, a decrease of $110.8 million compared to the previous year [26] Q&A Session Summary Question: Can you provide updates on Bysanti's FDA review and commercial strategy? - Management indicated optimism for an on-time approval and mentioned that commercialization would begin in Q3 2026 if approved [48] Question: What is the expected commercial infrastructure for Imsidolimab? - A small specialty sales force will be dedicated to marketing Imsidolimab, focusing on dermatologists and advocacy organizations [50] Question: Can you elaborate on promotional activities for Fanapt and Bysanti? - Current direct-to-consumer campaigns focus on Fanapt and Ponvory, with plans for a dedicated campaign for Bysanti upon its launch [52] Question: When will Nereus be commercially available? - Nereus is expected to be commercially available by late Q2 or early Q3 2026 [54] Question: What is the pricing strategy for Nereus? - While a specific price has not been communicated, it is expected to be at a premium compared to existing treatments for motion sickness [71]

Financial Data and Key Metrics Changes - Total revenues for the full year 2025 were $216.1 million, a 9% increase compared to $198.8 million for 2024 [16] - Net loss for the full year 2025 was $220.5 million, compared to a net loss of $18.9 million for 2024, primarily due to a one-time, non-cash income tax charge [18][19] - Operating expenses for the full year 2025 were $367.3 million, an increase from $239.4 million in 2024 [21] Business Line Data and Key Metrics Changes - Fanapt net product sales increased by 24% to $117.3 million in 2025, driven by a 28% rise in total prescriptions and a 149% surge in new-to-brand prescriptions [5][17] - HETLIOZ net product sales decreased by 7% to $71.4 million in 2025 due to generic competition [17] - Ponvory net product sales were $27.4 million, a slight decrease of 2% compared to 2024 [18] Market Data and Key Metrics Changes - Fanapt was one of the fastest-growing atypical antipsychotics in the market throughout 2025, with total prescriptions increasing by 36% in Q4 2025 compared to Q4 2024 [31] - The global long-acting injectable antipsychotic market is projected to be valued between $6 billion and $7 billion in 2025, with strong growth expected [11] Company Strategy and Development Direction - The company plans to launch Nereus for motion sickness, which was approved in late 2025, targeting a substantial market opportunity [6] - Vanda is preparing for the commercial launch of Bysanti, with a focus on transitioning patients from Fanapt [41] - The company aims to strengthen its psychiatric franchise with ongoing clinical development programs and potential new product approvals [15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the commercial potential of Nereus and the upcoming launch of Bysanti, anticipating continued revenue growth from existing products [15][34] - The company expects total revenues from marketed products in 2026 to be between $230 million and $260 million, indicating a growth of approximately 13% compared to 2025 [34] Other Important Information - Cash, cash equivalents, and marketable securities as of December 31, 2025, were $263.8 million, a decrease of $110.8 million compared to the previous year [23] - The company recorded a valuation allowance against all net deferred tax assets, resulting in a non-cash income tax expense of $113.7 million for 2025 [21] Q&A Session Summary Question: Can you characterize any FDA communication on Bysanti? - Management remains optimistic for an on-time approval and will provide more details on the launch strategy if approved [41][42] Question: What is the expected commercial infrastructure for Imsidolimab? - A small specialty sales force will be key for addressing the rare dermatological condition [44] Question: What promotional activities are planned for Fanapt and Bysanti? - A direct-to-consumer campaign for Fanapt and Ponvory is expected to continue, with a dedicated campaign for Bysanti planned if approved [45] Question: When will Nereus be commercially available? - Commercial materials are expected to be ready by late Q2 or early Q3 2026 [46] Question: What is the pricing strategy for Nereus? - Pricing is expected to be premium compared to existing treatments for motion sickness [65] Question: Will the phase 3 trial for tradipitant follow the same design as phase 2? - Yes, the design will be similar, using a high upfront dose of Wegovy [68]

Company Overview - Vanda Pharmaceuticals is a leading global biopharmaceutical company focused on innovating to enhance people's happiness [2] - The company employs an innovation-led strategy with a successful track record in developing and commercializing therapies over decades [2] Product Portfolio - Vanda has a robust commercial portfolio anchored by four FDA-approved brands: Fanapt (atypical antipsychotic), HETLIOZ (for two orphan sleep disorders), PONVORY (for multiple sclerosis), and the recently approved NEREUS (for motion-induced vomiting) [3] - The company maintains a strong debt-free balance sheet, providing substantial capital for R&D and commercial activities [3] Pipeline and Growth Potential - Vanda has a late-stage growth pipeline with numerous high-potential programs targeting significant unmet needs in billion-dollar markets [4] - The company is positioned for imminent regulatory catalysts, including the recently approved NEREUS [4]

Core Insights - Vanda Pharmaceuticals reported strong commercial execution in Q3 2025, with total net product sales reaching $56.3 million, an 18% increase year-over-year, driven by a 31% increase in Fanapt sales and a 35% growth in prescriptions [2][7] - The company is advancing its pipeline with multiple near-term regulatory milestones, including the NDA for tradipitant and Bysanti, both under FDA review, and the anticipated submission of the imsidolimab BLA [2][6] Financial Highlights - In Q3 2025, Vanda reported a net loss of $22.6 million, compared to a net loss of $5.3 million in Q3 2024, with diluted net loss per share at $0.38 [4][7] - For the first nine months of 2025, the net loss was $79.3 million, compared to $14.0 million in the same period of 2024, with diluted net loss per share at $1.35 [5][7] Operational Highlights – Commercial - Fanapt net product sales increased by 31% to $31.2 million in Q3 2025 compared to Q3 2024, while HETLIOZ sales were stable at $18.0 million, a 1% increase [7][6] - The direct-to-consumer campaign launched in Q1 2025 has significantly improved brand awareness for Fanapt and PONVORY [7] Operational Highlights – Regulatory & Clinical Development - The NDA for tradipitant for motion sickness is under FDA review with a PDUFA target action date of December 30, 2025, and the Bysanti NDA for bipolar I disorder and schizophrenia has a PDUFA target action date of February 21, 2026 [6][7] - A clinical study of tradipitant in preventing vomiting induced by Wegovy is complete, with results expected in Q4 2025 [7]

Core Insights - Vanda Pharmaceuticals announced the publication of a study demonstrating that HETLIOZ (tasimelteon) significantly improves sleep in patients with primary insomnia, meeting its primary endpoint with a mean improvement in latency to persistent sleep of 44.9 minutes (20mg) and 46.3 minutes (50mg) compared to 28.2 minutes for placebo [2][4]. Group 1: Study Findings - The study published in PLOS One showed that HETLIOZ met its primary endpoint with significant improvements in latency to persistent sleep (LPS) [2]. - Improvements in LPS were sustained through follow-up time points, indicating the potential long-term efficacy of HETLIOZ [2]. - No cognitive or mood changes were associated with HETLIOZ use, and no rebound or withdrawal effects were observed after discontinuation [2]. Group 2: Market Context - Insomnia affects over 10% of the American population, highlighting a significant health issue that Vanda Pharmaceuticals aims to address with HETLIOZ [3]. - HETLIOZ is already approved for Non-24-Hour Sleep-Wake Disorder and nighttime sleep disturbances in specific populations, with ongoing efforts for FDA approval for insomnia and Jet Lag Disorder [4]. Group 3: Company Overview - Vanda Pharmaceuticals is focused on developing innovative therapies to meet high unmet medical needs, particularly in the field of sleep disorders [5]. - The company is also pursuing the development of HETLIOZ for other sleep disorders, including Delayed Sleep Phase Disorder and pediatric insomnia [4].

Company Overview - Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) has several pipeline products approved for specific disorders, including Fanapt, HETLIOZ, and PONVORY [2] Investment Analysis - The Biotech Analysis Central service offers a comprehensive analysis of various pharmaceutical companies, including a library of over 600 biotech investing articles and a model portfolio of more than 10 small and mid-cap stocks [2]

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]

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]