Olivia Breyer

Olivia Breyer inquired about the commercial dynamics for Tyvaso, specifically share gains in PAH versus ILD, competitive impacts from Eutrepia, and sought clarification on the $4 billion revenue run rate by 2027.

Answer

Martine Rothblatt, Founder, Chairman, and CEO, confirmed the expectation of hitting $1 billion in quarterly revenue by 2027, driven by strong IPF results. Michael Benkowitz, President and COO, stated no material impact from Eutrepia, noting that competition often expands disease awareness. He highlighted Tyvaso DPI's strong positioning, continued growth in patient shipments, prescriber breadth and depth, and an upward trend in referrals and starts.

Olivia Breyer inquired about Tyvaso's commercial dynamics in recent months, competitive impacts from Eutrepia in PAH versus ILD, and sought clarification on the updated $4 billion revenue run rate guidance by 2027, including the expectation of hitting $1 billion quarterly.

Answer

Martine Rothblatt, Founder, Chairman, and CEO, confirmed the expectation of hitting $1 billion in quarterly revenue by 2027, driven by strong IPF results. Michael Benkowitz, President and COO, stated no material impact from Eutrepia's launch, noting that competition often expands the overall market. He reported strong patient shipments, growth in prescriber numbers, and an upward trend in referrals and starts, indicating a return to pre-Eutrepia launch levels. He expressed confidence in continued Tyvaso growth in both PAH and PH-ILD.

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.