Joshua Schimmer

Joshua Schimmer inquired about the adoption trends of LIVMARLI's solid tablet formulation, specifically its percentage of total sales compared to the liquid, and sought insights into appropriate pricing analogs for Volixibat, considering recent increases in rare orphan disease prices for less prevalent conditions than PBC.

Answer

President and COO Peter Radovich reported encouraging uptake of the solid tablet since its mid-June U.S. launch, with a substantial proportion of eligible patients (over 25 kilos) switching from the liquid formulation. Regarding Volixibat pricing, he stated that while no final decision has been made, initial base case thinking considers other PPARs and approved PBC products in the $130-$150 range, with ongoing analysis.

Joshua Schimmer of Cantor Fitzgerald asked for guidance on the long-term cost of goods sold (COGS) for neffy and clarification on whether the 57% of commercial lives with access require prior authorization.

Answer

President and CEO Richard Lowenthal clarified that the 57% commercial coverage is without prior authorization, noting that coverage with prior authorization is near 90%. CFO Kathleen Scott added that COGS will increase slightly over the next 18 months as the zero-cost inventory expensed pre-approval is utilized.

Joshua Schimmer of Evercore ISI asked about ARS Pharmaceuticals' expectations for neffy's gross-to-net adjustments, guidance for Q4 launch performance, the impact of inventory stocking, and the timeline for data from the chronic spontaneous urticaria (CSU) trial.

Answer

Executive Richard Lowenthal stated that gross-to-net expectations remain around 50%. While declining to provide specific Q4 guidance, he expressed strong optimism about early sales trends, noting that initial distributor inventory stocking was modest but is now accelerating. For the CSU trial, he anticipates patient dosing to begin in early 2025, with data expected by early 2026.

Joshua Schimmer questioned whether INGREZZA's current contracting strategy anticipates the future impact of competitor AUSTEDO's IRA price negotiation and if the expanded sales force's contribution materialized earlier than expected.

Answer

CEO Kyle Gano stated that while the primary goal of contracting is patient access, the IRA is a growing variable that the company is monitoring, particularly with an eye on competitors' situations in 2027. Chief Commercial Officer Eric Benevich clarified that the sales force's positive impact was in line with expectations, as it took a few quarters for the new team to become fully productive.

Joshua Schimmer requested quantification of the annual VYJUVEK price cap's impact in 2024 and 2025, and asked about new language in the 10-K regarding manufacturing process changes for the drug.

Answer

Christine Wilson, SVP and Head of U.S. Sales and Marketing, stated that approximately 8% of commercial patients have consistently been subject to the cap. Suma Krishnan, President of R&D, explained the manufacturing change was a successful and FDA-approved scale-up to a larger bioreactor, a process which de-risks CMC for the entire pipeline.