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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.
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Stifel 2025 Healthcare Conference summary12 Nov, 2025

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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44th Annual J.P. Morgan Healthcare Conference15 Jan, 2026
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44th Annual J.P. Morgan Healthcare Conference15 Jan, 2026

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Frequently asked questions

Vanda Pharmaceuticals Inc, a biopharmaceutical company, focuses on the development and commercialization of therapies to address high unmet medical needs. The company's marketed products include HETLIOZ (tasimelteon) for the treatment of non-24-hour sleep-wake disorders; and Fanapt (iloperidone) for the treatment of bipolar disorder. Its products under development include HETLIOZ (tasimelteon) for the treatment of jet lag disorder and smith-magenis syndrome; Tradipitant (VLY-686), a small molecule neurokinin-1 receptor (NK-1R) antagonist, for the treatment of atopic dermatitis, gastroparesis, and motion sickness; Fanapt oral tablets for the treatment of schizophrenia; Novel fixed dose combination products: anoro progesterone vaginal system/norethindrone acetate tablets in women

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