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Vanda Pharmaceuticals (VNDA) investor relations material
Vanda Pharmaceuticals Stifel 2025 Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Company overview and product portfolio
Operates as a global biopharmaceutical innovator with three commercialized products: Fanapt, Hetlioz, and Ponvory.
Fanapt is approved in the U.S. for bipolar disorder and schizophrenia; Hetlioz is approved for non-24-hour sleep-wake disorder and Smith-Magenis Syndrome; Ponvory is approved for multiple sclerosis.
Acquired Ponvory from Johnson & Johnson at the end of 2023.
Maintains a robust pipeline with several regulatory submissions and strong financials, holding $294 million in cash and no debt as of Q3 2025.
Pipeline and regulatory milestones
Basanti (active metabolite of Fanapt) NDA accepted by FDA, with a PDUFA action date in February 2026.
Phase 3 programs underway for Fanapt LAI (long-acting injectable) and Basanti in major depressive disorder, with results expected in 2026.
Hetlioz SNDA for jet lag under FDA re-review, with a decision expected by January 7, 2026.
Ponvory being developed for additional indications: psoriasis and ulcerative colitis.
Tradipitant NDA for motion sickness under review, with a PDUFA date of December 30, and phase 2 results for GLP-1-induced nausea expected in Q4 2025.
Imsidolumab BLA for generalized pustular psoriasis expected to be submitted by year-end, with potential priority review.
Commercial strategy and market dynamics
Focused on organic revenue growth and synergistic business development opportunities.
Expanded Fanapt sales force from 50 to 300 reps in 2024 to support the bipolar I disorder launch.
Retaining Hetlioz market share despite generic competition by focusing on indications not covered by generics.
Ponvory launch in multiple sclerosis showing increased patient demand through 2025.
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