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]