Vanda Pharmaceuticals (VNDA) H.C. Wainwright 28th Annual Global Investment Conference summary

Portfolio overview and recent approvals

• Five approved products in the U.S. market, with a sixth (imsidolimab for GPP) potentially approved by year-end.

• Recent launches include NEREUS for motion sickness and BYSANTI, an atypical antipsychotic for bipolar and schizophrenia.

• Multiple phase III clinical readouts expected by end of 2026 for HETLIOZ, VQW-765, and NEREUS in new indications.

• BYSANTI launch planned by year-end, with label expansion for MDD targeted for 2028 pending positive data.

• Diversified commercial portfolio with ongoing expansion and clinical milestones.

Financial outlook and investment trajectory

• Started the year with $260 million in cash, ending Q2 with $170 million due to high operating expenses from multiple launches and trials.

• Expenses expected to moderate starting Q4 2026 as major investments conclude.

• 2027 vision includes a growing psychiatry portfolio, BYSANTI launch, and a switch strategy as Fanapt loses exclusivity.

• Future investments and catalysts will depend on upcoming clinical readouts.

Psychiatry franchise strategy

• Fanapt has over 15 years on the market, with recent bipolar indication driving 30% revenue and script growth year-over-year.

• Fanapt expected to lose exclusivity at end of 2027; BYSANTI, a bioequivalent, will be positioned for patient switching and new patient growth.

• Medicaid price reset with BYSANTI expected to improve gross-to-net from 50% (Fanapt) to mid-30s, boosting revenue.

• Phase III MDD data for BYSANTI expected in early 2027, with potential label expansion in 2028.

• MDD market seen as highly attractive due to large, accessible patient population and significant unmet need.