Vanda Pharmaceuticals (VNDA) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Commercial product updates

• Three commercial products: Fanapt (schizophrenia, bipolar I), Hetlioz (non-24-hour sleep-wake disorder, Smith-Magenis syndrome), and Ponvory (multiple sclerosis), with recent acquisition of Ponvory for $100 million in December 2023.

• Fanapt approved for bipolar I disorder in April 2024; commercial launch for acute bipolar I disorder began in Q3 2024.

• Hetlioz faces generic competition but focuses on patient loyalty and market share retention; pursuing new indications including insomnia and jet lag disorder.

• Ponvory commercial launch in multiple sclerosis began in Q3 2024; IND filings for psoriasis and ulcerative colitis planned by year-end.

• Tradipitant targets gastroparesis (PDUFA date September 18, 2024) and motion sickness (NDA filing by year-end).

Pipeline and regulatory milestones

• NDA for milsaperidone (active metabolite of Fanapt) for bipolar I and schizophrenia planned for early 2025; phase III for major depressive disorder to start by end of 2024.

• Fanapt long-acting injectable phase III to begin by end of 2024; potential U.S. market entry after 2026, with patent exclusivity possibly into the 2040s.

• Hetlioz pediatric insomnia phase III and Non-24 pediatric program to initiate by end of 2024.

• Tradipitant NDA for gastroparesis accepted; phase III and pooled analyses show efficacy in symptom relief.

• Motion sickness program completed two positive phase III trials; NDA submission expected by year-end.

Research and early-stage development

• Early-stage assets include CFTR activator (VSJ-110, phase II for dry eye), CFTR inhibitor (VPO-227, orphan drug for cholera), HDAC inhibitor (VTR-297, phase II for hematologic malignancies), and phase I for onychomycosis.

• VQW-765 completed phase II for social performance anxiety in December 2022.

• ASO platform in partnership with OliPass for novel peptide nucleic acids, with ongoing discovery and development.