Vanda Pharmaceuticals (VNDA) Corporate presentation summary

Strategy and portfolio

• Strategy centers on growing revenue across existing products, diversifying toward six approved products by end-2026, advancing pipeline programs and improving patient access and affordability.

• Portfolio includes FDA-approved Fanapt, BYSANTI, HETLIOZ, PONVORY and NEREUS across psychiatry, sleep disorders, multiple sclerosis and motion sickness.

• The presentation highlights a debt-free balance sheet, a late-stage pipeline and potential commercial expansion in 2026 and 2027.

Commercial portfolio and demand

• BYSANTI was FDA-approved on Feb. 20, 2026, for bipolar I disorder and schizophrenia; its once-daily adjunctive MDD Phase III study is enrolling, with results expected in 1H 2027.

• Fanapt prescriptions grew YoY from Q2 2025 to Q2 2026: TRx +31%, NRx +42% and new-to-brand prescriptions +32%.

• HETLIOZ retains leading market share despite generic competition, with continued U.S. SMS growth priorities; PONVORY is promoted in all 50 states, with underlying patient demand increasing.

• NEREUS was approved for prevention of motion-induced vomiting and became available through a direct-to-consumer platform on May 1, 2026.

Pipeline and catalysts

• NEREUS Phase III study for GLP-1-induced nausea and vomiting is enrolling, with results expected in 2026; a Phase II study reported 50% relative symptom reduction at therapeutic doses and met primary and secondary endpoints.

• In the Phase II study, vomiting occurred in 29.3% with tradipitant vs. 58.6% with placebo (p=0.0016); vomiting with moderate-or-worse nausea occurred in 22.4% vs. 48.3% (p=0.0039).

• Imsidolimab’s GPP BLA was accepted with a Dec. 12, 2026 PDUFA target; Phase III studies reported rapid improvement after single IV doses and maintained clearance with every-four-week dosing.

• Fanapt LAI schizophrenia program is in Phase III; studies are underway for uncontrolled hypertension, while HETLIOZ programs include Phase III development in delayed sleep phase disorder and pediatric insomnia.

• FDA granted a formal evidentiary public hearing on March 3, 2026, to review the proposed refusal of HETLIOZ for jet lag disorder; the agency had concluded on Jan. 7 that the application could not be approved in its current form.