Vanda Pharmaceuticals (VNDA) investor relations material

Portfolio and pipeline

• Five marketed products: Fanapt and Bysanti for schizophrenia and bipolar disorder; HETLIOZ for two U.S. sleep indications; PONVORY for MS; and Nereus for motion sickness.

• Imsidolimab, in-licensed from Anaptys, was under FDA review for generalized pustular psoriasis; its PDUFA date was in December, with approval possible that month.

• Four Phase III readouts had occurred; recent results included positive Nereus motion-sickness and GLP-1-related vomiting studies.

Cash and spending

• Cash was ~$140 million at Q3-end, versus ~$260 million at the prior year-end; spending reflected late-stage trials, launch inventory and commercial infrastructure investments.

• Q3 operating expenses fell to $93 million from $114 million in Q2; further moderation was expected, with cash projected to last through at least 2027.

• Maintaining the psychiatry franchise beyond Fanapt’s expected late-2027 loss of exclusivity was described as critical to runway and funding activity.

Fanapt and Bysanti

• Following the 2024 bipolar approval, Fanapt prescription volume grew over 30% last year and was tracking similarly this year; roughly 10,000 patients were on therapy monthly.

• Fanapt represented ~2% of the branded atypical antipsychotic market; its sales force had expanded from ~50 to ~300 representatives.

• Bysanti launch was planned by year-end, with roughly a year of overlap before Fanapt’s expected late-2027 loss of exclusivity; Bysanti gross-to-net was expected in the mid-30s versus ~50% for Fanapt.

• Bysanti access was expected to be similar to Fanapt’s; government coverage for Fanapt was 80%-90%, while commercial coverage was below 50%.

• Bysanti uptake could build over its first year, with a slower first month or two and fuller launch impact from months three to four onward; inventory across multiple strengths and configurations was the main launch gating factor.