Vanda Pharmaceuticals (VNDA) Cantor Global Healthcare Conference 2025 summary

Company overview and commercial portfolio

• Three commercial products: Fanapt (schizophrenia, bipolar), Hetlioz (non-24-hour sleep-wake disorder, Smith-Magenis syndrome), and Ponvory (multiple sclerosis).

• Hetlioz faces generic competition but maintains majority market share and is also marketed in Germany.

• Ponvory acquired from J&J in 2023, showing increased patient demand and plans for new indications.

Pipeline and regulatory milestones

• Three upcoming PDUFA dates: tradipitant (Dec 2025), milsaperidone (Feb 2026), imsidolimab (BLA submission expected late 2025, PDUFA in H2 2026).

• Milsaperidone phase III for major depressive disorder, results expected 2026, potential label expansion by 2027/2028.

• Fanapt long-acting injectable in phase III for schizophrenia, possible market entry after 2027.

Financial position and guidance

• Ended Q2 with $325M cash, no debt; year-end cash guidance $280–$320M.

• 2025 revenue guidance $210–$250M (midpoint $230M); Q2 revenue $53M, Fanapt revenue $29.3M.

• Cash burn projected at $75M for the year, including $15M payment for imsidolimab in-licensing.