Core Viewpoint - Vanda Pharmaceuticals Inc. (VNDA) shares surged over 40% in after-hours trading following FDA approval of BYSANTI, a new treatment for bipolar I disorder and schizophrenia in adults [1] Group 1: Product Approval and Market Impact - The FDA has approved BYSANTI as a first-line therapy for acute treatment of manic or mixed episodes associated with bipolar I disorder and for schizophrenia in adults [1] - BYSANTI is expected to be commercially available in the third quarter of this year [1] - Following the approval, VNDA shares closed at $5.76, down 5.57% during regular trading, but rose to $8.30 in after-hours trading [3] Group 2: Intellectual Property and Future Developments - BYSANTI will be protected by regulatory data exclusivity and U.S. patents, with the last patent expiring in 2044, which supports long-term innovation and patient benefits [2] - This approval marks the second new drug for Vanda in less than two months, following the approval of NEREUS for motion-induced vomiting in December 2025 [3] - A phase 3 trial for BYSANTI as a once-daily adjunctive treatment for major depressive disorder (MDD) is currently underway, with results expected this year [3] Group 3: Stock Performance - VNDA has traded between $3.81 and $9.60 over the past year [3]

US FDA approves Vanda's psychiatric drug | ReutersSkip to main content[Exclusive news, data and analytics for financial market professionalsLearn more aboutRefinitiv]Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly//File Photo [Purchase Licensing Rights, opens new tab]- Companies[Vanda Pharmaceuticals Inc]FollowFeb 20 (Reuters) - The U.S. Food and Drug Administration has approved Vanda Pharmaceutical's [(VNDA.O ...

Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at [www.sec.gov].All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is ...

Group 1 - Vanda Pharmaceuticals Inc. reported a disappointing 4Q25 with a GAAP EPS of -$2.39, missing consensus by approximately $1.07 [1] - The company's revenue for the quarter was $57.22 million, which fell short of expectations by about $2.05 million [1] Group 2 - The article emphasizes the importance of evaluating the science behind drug candidates, the competitive landscape, clinical trial design, and potential market opportunities in the biotech sector [1] - It highlights the need for careful scrutiny in biotech investments, where breakthrough science can lead to significant returns but also carries inherent risks [1]

Sales and Market Focus - Vanda Pharmaceuticals reported a focus on generating U.S. sales of Fanapt (iloperidone) for schizophrenia and bipolar I disorder treatment[11] - Vanda Pharmaceuticals Inc. is focused on generating U.S. sales of Fanapt (iloperidone) for schizophrenia and bipolar I disorder, with ongoing efforts to increase market awareness and acceptance[1] - Vanda is working to increase market awareness and acceptance of HETLIOZ for Non-24 and Smith-Magenis syndrome[11] - HETLIOZ (tasimelteon) sales are being impacted by existing and potential generic competition, with a focus on expanding its use for Non-24-Hour Sleep-Wake Disorder and Smith-Magenis syndrome[1] - Vanda is working to commercialize PONVORY (ponesimod) for relapsing forms of multiple sclerosis in the U.S.[11] - Vanda is working to commercialize PONVORY (ponesimod) for relapsing forms of multiple sclerosis and is pursuing FDA approval for additional indications[1] Regulatory Approvals - The company aims to obtain FDA approval for Bysanti (milsaperidone) for bipolar I disorder, schizophrenia, and major depressive disorder[11] - The company is seeking FDA approval for Bysanti (milsaperidone) for bipolar I disorder, schizophrenia, and major depressive disorder (MDD)[1] - Vanda is seeking FDA approval for NEREUS (tradipitant) for motion-induced vomiting and gastroparesis[11] - Regulatory approval for new product candidates, including NEREUS and imsidolimab, remains uncertain, impacting future growth prospects[1] Competition and Market Risks - HETLIOZ (tasimelteon) sales are expected to face challenges due to existing and potential generic competition[11] - The company faces risks related to pricing and reimbursement policies in the U.S., impacting product sales[17] - The company is subject to competition that may affect the commercial success of its products[17] - The company faces challenges with reimbursement and patient access for HETLIOZ, which may affect sales performance[1] - The company is dependent on the commercial success of its products, including Fanapt, HETLIOZ, PONVORY, and NEREUS, amid competitive pressures[1] Operational Risks - Vanda relies on third-party manufacturers for product supply, which poses risks to production capacity[17] - Vanda relies on third-party manufacturers for product supply, which poses risks to meeting demand and quality standards[1] - Global economic conditions and health crises may adversely impact Vanda's business operations[17] - The company is subject to various risks, including pricing and reimbursement policies, which could materially affect its financial condition and operations[1] Human Resources - Vanda's ability to attract and retain key personnel is critical for its research and development efforts[1]

Core Insights - Vanda Pharmaceuticals reported a quarterly loss of $0.46 per share, significantly better than the Zacks Consensus Estimate of a loss of $2.18, representing an earnings surprise of +78.85% [1] - The company posted revenues of $57.22 million for the quarter ended December 2025, missing the Zacks Consensus Estimate by 2.78%, but showing an increase from $53.19 million year-over-year [2] - Vanda shares have underperformed the market, losing about 15.9% since the beginning of the year compared to the S&P 500's gain of 1.4% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.24 on revenues of $64 million, and for the current fiscal year, it is -$1.47 on revenues of $275.85 million [7] - The estimate revisions trend for Vanda was favorable ahead of the earnings release, resulting in a Zacks Rank 2 (Buy) for the stock, indicating expected outperformance in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Vanda belongs, is currently in the top 35% of over 250 Zacks industries, suggesting a favorable outlook for stocks within this sector [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

For Hetlioz, full-year net product sales fell 7% to $71.4 million. Moran said the decline reflected lower volume and price net of deductions amid continued U.S. generic competition, while noting the brand “continued to retain the majority of market share despite generic competition now for over three years.” Ponvory net product sales were $27.4 million, down 2% versus 2024, with the company also noting that certain variable consideration tied to Ponvory sales remains subject to dispute.Total 2025 revenues a ...

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 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 [21][22] - Operating expenses for the full year 2025 were $367.3 million, an increase from $239.4 million in 2024 [24] Business Line Data and Key Metrics Changes - Fanapt net product sales were $117.3 million for 2025, a 24% increase from $94.3 million in 2024, driven by a 28% rise in total prescriptions and a 149% surge in new-to-brand prescriptions [5][19] - Hetlioz net product sales were $71.4 million for 2025, a 7% decrease from $76.7 million in 2024, impacted by 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 - 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 [37] - The total addressable market for the antipsychotic category was estimated at approximately $20 billion in 2025 [7] - The global long-acting injectable antipsychotic market is projected to be in the $6 billion-$7 billion range for 2025, with strong growth expected [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 psychiatry franchise with the anticipated approval of Bysanti for bipolar I disorder and schizophrenia, with a PDUFA target action date of February 21, 2026 [8][17] - The company is committed to delivering innovative therapies and long-term value for patients and shareholders [17] 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 [17][40] - Management highlighted the importance of strategic investments in commercial infrastructure to support long-term market leadership [26] Other Important Information - The company recorded a valuation allowance of $113.7 million against all deferred tax assets, which is a one-time, non-cash charge [22][24] - 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 characterize any FDA communication on outstanding issues related to Bysanti? - Management remains optimistic for an on-time approval and will provide more details on the launch strategy once commercial supplies are ready [48] Question: What is the expected commercial infrastructure for imsidolimab? - A small specialty sales force will be key for addressing the rare dermatological condition associated with imsidolimab [50] Question: Can you provide details 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? - Commercial materials are expected to be ready by late Q2 or early Q3 2026 [54] Question: What is the expected pricing for Nereus? - Pricing is not yet communicated, but 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 [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]