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]