Catherine

Catherine, on behalf of Jon Wolleben, asked if BioCryst is observing any impact from recent new entrants, including oral acute therapies, on ORLADEYO. She specifically inquired about patient switching patterns to ORLADEYO or changes in reasons for switching, and any anticipated or current revenue impacts.

Answer

President and CEO Charlie Gayer stated that new prophy entrants have not impacted ORLADEYO, as they primarily compete with existing injectables. He noted no negative effect from oral acute therapies and suggested a potential long-term tailwind for ORLADEYO from patients seeking an all-oral combination for prophylaxis and breakthrough attacks.

Catherine asked if BioCryst is observing any impact on ORLADEYO from recent new entrants, including oral acute therapies. She inquired about patient switching patterns, any revenue impact, and future expectations regarding competitive dynamics.

Answer

President and CEO Charlie Gayer stated that BioCryst has not seen an impact on ORLADEYO from new prophy entrants, as injectables primarily compete with other injectables. He noted that oral acute therapies are not negatively affecting ORLADEYO and could potentially create a tailwind for an all-oral combination strategy in the future, though it's too early to confirm.

Catherine asked about potential risks associated with using the ordinal two-step DRSS endpoint for the DR program, particularly concerning a smaller patient population, higher placebo effect, or patient variability compared to traditional endpoints.

Answer

Pravin U. Dugel, Executive Chairman, President and CEO, expressed strong confidence in the ordinal endpoint, citing overwhelming success data from the Helios 1 study where a single XPAXLY injection showed improvement across all parameters for DR and DME patients. He highlighted that Helios 2 has an FDA-approved SPA validating the study design and endpoint, and both Helios 2 and 3 are superiority studies.

Catherine asked about the number of scripts and patients that contributed to the $1.4 million in revenue reported for July and inquired about the exact date ECTERLEET became commercially available in July following its approval.

Answer

Ben Palleiko, CEO, stated that ECTERLEET became available roughly 10 days after approval, with the first start forms received on the day of approval, predating actual shipments. Ryan Baker, Head of Investor Relations, clarified that revenue is recognized when the product is received by specialty pharmacies, in accordance with ASC 606, with a subsequent lag until it reaches patients.

Catherine asked about the number of scripts and patients that contributed to the reported $1.4 million in revenue for July, and when EKTERLY became commercially available following its approval.

Answer

Ben Palleiko, CEO, stated that EKTERLY became available approximately 10 days after approval, with patient start forms beginning on the day of approval. Brian Piekos, CFO, clarified that revenue is recognized when the product is received by specialty pharmacies, in accordance with ASC 606, with a subsequent lag until it reaches patients.