Vanda Pharmaceuticals Inc. Q4 FY2025 earnings call

• Lead product Fanapt drove strong growth: full year net product sales up 24% to $117.3M, with 28% rise in total prescriptions and 149% surge in new-to-brand prescriptions. - Achieved regulatory win with FDA approval of Nereus tradipitant for motion sickness prevention, a first in over 40 years, with potential in GLP-1 adjunct market. - [indiscernible] NDA for bipolar 1 disorder in schizophrenia under FDA review with PDUFA date Feb 21, 2026. - Clinical programs ongoing, including PONVORY in psoriasis and ulcerative colitis, and Phase III study of VQW765 in social anxiety disorder.

For the full year 2025, Vanda's product segments showed the following performance: Fanapt had net product sales of $117.3 million, a 24% increase from 2024, contributing significantly to revenue. HETLIOZ had net product sales of $71.4 million, a 7% decrease due to generic competition. PONVORY had product sales of $27.4 million, a 2% decrease. In the fourth quarter of 2025, Fanapt net product sales were $33.2 million, a 25% increase; HETLIOZ net product sales were $16.4 million, an 18% decrease; PONVORY net product sales were $7.6 million, a 17% increase.

• 2026 total revenues from current marketed products (Fanapt, HETLIOZ, HETLIO LQ, PONVORY) expected to be $230M-$260M. - Fanapt net product sales projected to be $150M-$170M. - Other net product sales expected to be $80M-$90M. - Quarterization of revenue in 2026 impacted by factors like insurance plan transitions and HETLIOZ inventory levels.

• Generic competition continuing to impact HETLIOZ sales. - Uncertainties in clinical trial timelines and regulatory approval processes for various programs. - Risks associated with the quarterization of cash balances and cash burn projections.

Q: Characterization of FDA communication on [indiscernible] NDA and commercial strategy A: The NDA is not a bioequivalent like a generic. We remain optimistic for on-time approval. Commercial launch would be in Q3 when commercial supplies are ready, with further color on launch strategy later.

Q: Expectations for commercial infrastructure size and scope for imsidolimab assuming timely approval A: A dedicated small specialty sales force visiting dermatologists and advocacy organizations will be key, given GPP is rare and awareness has increased since 2021 approval of specolimab Q: Details on Nereus commercial availability, regulatory outlook in gastroparesis, and Phase III trial for GLP-1 A: Expect commercial materials available by late Q2 or early Q3. Preparing for FDA hearing on gastroparesis. Initiating Phase III study in first half of 2026, results expected late 2026 Q3/Q4 Q: Completion of enrollment in iloperidone LAI Phase III program A: The program is enrolling, but recruitment speed is slowed by delays in launching the study in Europe, and no certainty on completing enrollment by end of year