Vanda Pharmaceuticals (VNDA) 2024 Wells Fargo Healthcare Conference summary

Commercial portfolio and product updates

• Three commercialized products: Fanapt (schizophrenia, bipolar I), Hetlios (non-24, SMS), and Ponvory (multiple sclerosis).

• Fanapt approved for bipolar I in April 2024; commercial launch activities underway.

• Hetlios faces generic competition; focus on patient loyalty and new indications like insomnia and jet lag disorder.

• Ponvory acquired in late 2023; commercial launch in MS market started Q3 2024.

• Tradipitant NDA for gastroparesis accepted; PDUFA date September 18, 2024.

Pipeline and regulatory milestones

• NDA for milsoperidone (Fanapt metabolite) in bipolar I and schizophrenia planned for early 2025.

• Major depressive disorder program for Fanapt to begin by end of 2024.

• Long-acting injectable Fanapt phase 3 in schizophrenia to start by end of 2024; potential market entry after 2026.

• Hetlios pediatric insomnia program to initiate by year-end; delayed sleep phase disorder in phase 3.

• Ponvory IND filings for psoriasis and ulcerative colitis expected by end of 2024.

Clinical data highlights

• Tradipitant pooled phase 2/3 data show efficacy in gastroparesis; significant commercial opportunity with 6 million US patients.

• Motion sickness program: two positive phase 3 studies; NDA filing expected by year-end.

• CFTR activator VSJ110 in phase 2 for dry eye; VPO227 granted orphan drug status for cholera.

• VTR297 in phase 2 for hematologic malignancies; phase 1 for onychomycosis started.

• ASO platform advancing with orphan drug designation for VCA894A in CMT2S.