Vanda Pharmaceuticals (VNDA) investor relations material

Company overview and product portfolio

• Five approved products in the U.S., including Fanapt, Hetlioz, Ponvory, Nereus, and BYSANTI, with two new approvals in the last three months.

• Strong, debt-free balance sheet with over $260 million in cash at year-end.

• Late-stage pipeline includes multiple Phase III programs and imminent regulatory catalysts.

• Strategic focus on revenue growth, diversification, and advancing the pipeline.

• Emphasis on increasing patient access and affordability.

Psychiatry portfolio and BYSANTI launch

• Fanapt generated $117 million in 2025, projected to reach $150–$170 million in 2026, with LOE at end of 2027.

• BYSANTI, newly approved for bipolar disorder and schizophrenia, benefits from favorable Medicaid pricing and patent protection into the mid-2040s.

• BYSANTI launch planned for Q3, leveraging existing 300-person psychiatry sales force.

• BYSANTI expected to surpass Fanapt in demand, especially with potential MDD label expansion.

• Psychiatry portfolio targets $750 million revenue by 2030, contingent on BYSANTI and Fanapt LAI approvals and MDD expansion.

Pipeline and R&D milestones

• BYSANTI Phase III study in major depressive disorder (MDD) with results expected by end of 2026.

• Fanapt LAI in Phase III for schizophrenia; BYSANTI LAI also under consideration for longer dosing intervals.

• Hetlioz at regulatory stage for insomnia and jet lag disorder; Ponvory in Phase III for ulcerative colitis and psoriasis.

• Imsidolimab BLA accepted with PDUFA date of December 12, 2026, targeting generalized pustular psoriasis.