Vanda Pharmaceuticals (VNDA) Jefferies 2024 Global Healthcare Conference summary

Corporate overview and product portfolio

• Three commercialized products: Fanapt (bipolar disorder, schizophrenia), HETLIOZ (Non-24-Hour Sleep-Wake Disorder, SMS), and PONVORY (multiple sclerosis).

• HETLIOZ LQ approved for pediatric SMS in the U.S.; HETLIOZ approved in Europe for Non-24-Hour Sleep-Wake Disorder.

• PONVORY acquisition completed in December 2023; full U.S. commercialization rights transferred in May.

• Robust pipeline with multiple regulatory submissions and products in various development stages.

• Strong financial position with nearly $400 million in cash and no debt as of Q1 2024.

Commercial and pipeline strategy

• Fanapt recently approved for bipolar I disorder; NDA for milsaperidone planned for early 2025.

• Phase III program for long-acting injectable Fanapt to begin by end of 2024.

• HETLIOZ programs for insomnia and jet lag disorder completed; pursuing further FDA approvals.

• PONVORY phase III studies in psoriasis and ulcerative colitis to start by year-end.

• Tradipitant NDA for gastroparesis accepted; PDUFA date in September 2024; motion sickness NDA expected by year-end.

Market opportunities and product differentiation

• Bipolar market offers 2x–4x revenue potential over schizophrenia; Fanapt expected to benefit from class dynamics and promotional sensitivity.

• Milsaperidone may offer less frequent dosing as a long-acting injectable, differentiating it from Fanapt.

• PONVORY expected to grow with active promotion and targeted sales force, aiming to match or exceed peer performance.

• Tradipitant addresses significant unmet need in gastroparesis; large market potential with 6 million U.S. patients.

• Motion sickness market is substantial, with 2–3 million doses of dramamine sold monthly; tradipitant offers improved safety profile.