Catherine

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.