Vanda Pharmaceuticals(VNDA) - 2025 Q4 - Annual Report

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]