Outlook Therapeutics (NasdaqCM:OTLK) FY Conference Transcript

Summary of Outlook Therapeutics FY Conference Call Company Overview - Company: Outlook Therapeutics (NasdaqCM:OTLK) - Product: Ophthalmic form of bevacizumab for the treatment of wet age-related macular degeneration (AMD) Key Points Regulatory Updates - Received a Complete Response Letter (CRL) from the FDA in late August 2025 due to the NORSE 1 trial missing its primary endpoint [2] - The NORSE 1 trial's eight-week endpoint was agreed upon under a Special Protocol Assessment (SPA) but was deemed not clinically relevant compared to the 12-week endpoint [3][5] - The NORSE 2 trial demonstrated non-inferiority and superiority against ranibizumab, providing confirmatory evidence for approval [7] - The FDA did not raise any manufacturing or chemistry, manufacturing, and controls (CMC) issues in the CRL [2][15] - A Type A meeting with the FDA was held to discuss the CRL, leading to a rapid resubmission and a Class 1 review with a PDUFA date before the end of the year [12][14] Clinical Trial Insights - NORSE 1 trial missed the eight-week endpoint but provided supportive data from the 12-week and retinal thickness measurements [4][10] - Visual acuity scores and retinal thickness changes were similar between the ophthalmic bevacizumab and ranibizumab arms, indicating a class effect [9][10] - Safety and tolerability across the NORSE program were reported as very good and consistent, addressing concerns with compounded bevacizumab [11] Market Landscape - Approximately 3 million injections of compounded anti-VEGF treatments are administered annually, with nearly 50% of patients receiving compounded bevacizumab as a first-line option [18] - Bevacizumab accounts for around 44% of all anti-VEGF injection claims, while ranibizumab has historically held a lower market share [23] - The company aims to position its FDA-approved product as the first and only approved bevacizumab for wet AMD, differentiating from compounded versions [19] Competitive Dynamics - New entrants like Eylea HD and Vabysmo are expected to increase competition, but compounded bevacizumab is likely to remain a frontline option due to affordability and access considerations [25] - Pricing strategy will be informed by experiences in Germany and the U.K., with expectations to align with biosimilar pricing [29][31] Commercial Strategy - The company plans to build a commercial infrastructure with a team of 30 to 50 personnel, focusing on market access and reimbursement management [34] - The transition from compounded forms to the approved product will depend on establishing confidence in coding, billing, and reimbursement processes [36] European Market Progress - The product was approved in the U.K. and Germany, with 77% market access achieved in Germany [39] - The company is activating hospitals and negotiating pricing, with a slower rollout in Germany due to inherent market challenges [40][42] - Future launches are planned for Austria, the Netherlands, and Scotland [44] Additional Insights - The company emphasizes the importance of a high-quality product that meets FDA standards, differentiating it from compounded alternatives [22] - The historical reliance on compounded bevacizumab raises questions about the transition to an FDA-approved product, with potential institutional risks influencing physician choices [37]