Vanda (VNDA) Q2 FY26 earnings call: guidance and Q&A

With three months of Nereus launch experience, where are the biggest drop-offs in the patient funnel, and what metrics should investors watch to judge if 2026 sales will be at the low or high end of the $10M-$30M range?

Management stated it's very early in the launch phase. Personal promotion with the sales force will begin later in 2026. Key metrics for investors to watch include sales engagement, doctor receptivity, patient acquisition, refill rates, and pills-per-fill metrics, though current data is minimal.

“As far as metrics go for what folks should be looking for there, I think that as we continue to report going forward, the sales engagement and the visits that we see with doctors and the receptivity to the product in the market is going to be important to seeing what trends we see as far as revenue goes.”

asked by Raghuram Ram Silvaraj (H.G. Wainwright) · answered by Kevin Moran

Following the pre-hearing conference and evidentiary disclosure deadline, what became clear about the HETLIOs hearing, and which issue is most likely to drive the outcome (e.g., interpretation of sites, endpoint validity)?

Management clarified that the pre-hearing was a process call, not focused on facts. They declined to speculate on litigation outcomes or strategy but expressed confidence in presenting their case to the administrative law judge, hoping for a favorable recommendation in early 2027.

“Yes, that's right. And so obviously it's never a good idea to speculate about the outcome of litigation or litigation strategy. But, you know, we are confident in our ability to present our case to the administrative law judge, the process will continue throughout the year and we're hoping obviously for a favorable recommendation from the judge early in 2027.”

asked by Raghuram Ram Silvaraj (H.G. Wainwright) · answered by Unknown Speaker

When will Nereus personal promotion start, how many reps will be involved, and does this fit within the guided OpEx moderation? Is the OpEx moderation more R&D or SG&A driven, and what drove Q2 R&D expense?

Management stated Nereus personal promotion will use existing FENAPT (300 reps) and Pomvori (50 reps) sales forces, with the exact structure to be determined. OpEx moderation is primarily driven by the conclusion of Phase 3 programs and commercial production activities. Q2 R&D expense increase was due to ramping up VQW and Nereus programs, and expensing pre-commercial product inventory (like Imsidolimab) before approval.

“So as we, you know, have now are reaching the end of those activities with the readouts of the clinical trials, you know, kind of right in front of us and the launch materials, you know, either made or being made shortly, those will be driving the most, you know, significant reductions in operating expenses as we head towards the end of 2026 and into 2027.”

asked by Madison Wynne El-Saadi (B Riley securities) · answered by Kevin Moran

What gives Vanda confidence in the VQW765 Phase 3 study, given prior Phase 2 data, and why could efficacy look even better in Phase 3?

Management stated the Phase 3 study design is similar to the Phase 2 study, which showed a significant effect in reducing anxiety and a clear dose-response. The Phase 3 study is appropriately powered based on learnings from the Phase 2 study, with minimal design changes and no change in dose.

“The Phase III study that we're running now is similar in design with the Phase II study, with a similar setup and similar primary endpoint. And we have reported prior. results there with two observations. One, a significant effect in reducing anxiety measures in that setting, but also understanding of a dose-response curve.”

asked by Andrew Tsai (Jefferies) · answered by Unknown Speaker

Can Vanda discuss its filing strategy and timing for Nereus in GLP-1 induced vomiting, and has the FDA aligned on the Phase 3 trial design? What are the latest hopes relative to Phase 2 findings?

Management reiterated positive Phase 2 results where 60% of placebo patients vomited versus 30% on Nereus. They believe the current Phase 3, which aims to confirm prior findings, along with existing Nereus experience, will support a supplemental NDA (sNDA). They continue to communicate with the FDA on the statistical analysis plan for this study.

“We believe that this body of evidence, alongside with all the new use experiences for this approved product, would support the new use of the product. suffice for the filing of a supplemental NDA. We continue to communicate with the FDA on the statistical analysis plan on this study, and we will see how the results go, and we'll continue those conversations.”

asked by Andrew Tsai (Jefferies) · answered by Unknown Speaker