Vanda Pharmaceuticals Inc. Q3 FY2025 earnings call

Management Statement and Operational Highlights

• Commercial Execution: Total net product sales in Q3 2025 reached $56.3 million, up 18% year-over-year, led by a 31% increase in Fanapt sales and 35% growth in prescriptions. HETLIOZ had $18 million in Q3 sales. The first 9 months of 2025 saw total revenue from Fanapt, HETLIOZ, and PONVORY at $158.9 million.
• Pipeline Updates: Tradipitant NDA for motion sickness is under FDA review with a PDUFA target of December 30, 2025; Bysanti NDA for bipolar I disorder and schizophrenia has a PDUFA target of February 21, 2026; imsidolimab BLA for generalized pustular psoriasis expected in Q4 2025. Phase III studies ongoing for various indications.
• Infrastructure Investments: Expanded sales force for Fanapt (now ~300 representatives), direct-to-consumer campaigns driving brand awareness, and strategic investments in commercial infrastructure via targeted sponsorships.

Segment Performance

• Fanapt: Q3 2025 net product sales were $31.2 million, a 31% increase compared to Q3 2024. For the first 9 months of 2025, Fanapt net product sales were $84.1 million, a 24% increase compared to the same period in 2024.
• HETLIOZ: Q3 2025 net product sales were $18 million, a 1% increase compared to Q3 2024. For the first 9 months of 2025, HETLIOZ net product sales were $55 million, a 3% decrease compared to the same period in 2024.
• PONVORY: Q3 2025 net product sales were $7 million, a 20% increase compared to Q3 2024 but a 1% decrease compared to Q2 2025. For the first 9 months of 2025, PONVORY net product sales were $19.8 million, a 7% decrease compared to the same period in 2024.

Guidance

• Revised 2025 total revenues from Fanapt, HETLIOZ, and PONVORY to between $210 million and $230 million (down from prior range of $210 million to $250 million).
• Year-end 2025 cash guidance revised to between $260 million and $290 million (down from prior range of $280 million to $320 million), reflecting investments in R&D and commercial infrastructure.

Risks

• Uncertainties in HETLIOZ sales due to continued generic competition in the U.S., with potential significant declines in future periods.
• Variability in HETLIOZ net product sales related to inventory stocking by specialty pharmacy customers.
• Timing uncertainties in clinical trial completions, such as the Phase III study of iloperidone long-acting injectable.

Q: Could you comment on hypothetical scenarios with respect to interactions with the FDA, particularly regarding tradipitant approval?

A: We have a collaborative framework with the FDA. Tradipitant review is ongoing with a PDUFA target of December 30, 2025. The FDA is reconsidering a partial clinical hold, and if cleared, we're optimistic for approval by year-end.

Q: Talk about PONVORY performance and future growth expectations?

A: PONVORY had underlying patient demand increases in the last 2 quarters. We've invested in the sales force, and underlying demand is encouraging, with hope for continued growth as investments take hold.

Q: Discuss guidance change and Bysanti engagement with the FDA?

A: Revenue guidance revised due to strong Fanapt growth but variable HETLIOZ sales. For Bysanti, interactions with the FDA have been positive, and label discussions typically precede the PDUFA date. Commercial strategy for Bysanti leverages the promotionally sensitive and high-switch nature of the atypical antipsychotic class.

Q: Marketing strategy for tradipitant and HETLIOZ approvals?

A: Consumer-centric strategies with concierge service, leveraging direct-to-consumer campaigns and brand awareness for launches in 2026.