Olivia Breyer's questions to Vanda Pharmaceuticals Inc (VNDA) leadership • Q2 2025
Question
Olivia Breyer of Cantor Fitzgerald asked about the progress of Vanda's interactions with the FDA on the Bisanti review, the expected margins and Medicaid impact for Bisanti post-launch, and the agency's stance on requiring one versus two Phase 3 studies for the Major Depressive Disorder (MDD) indication.
Answer
President, CEO & Chairman Mihael Polymeropoulos stated that the Bisanti review is proceeding with ordinary questions and no major issues raised by the FDA. He noted that for the MDD indication, a single large, successful study could be adequate for approval, citing the Fanapt bipolar I approval as a precedent. CFO Kevin Moran detailed the significant potential for gross-to-net improvement with Bisanti, explaining that its Medicaid rebate would reset to the statutory minimum of 23.1%, compared to Fanapt's current effective 100% rebate, potentially cutting the overall gross-to-net from ~50% to the 25-30% range.