Ocular Therapeutix(OCUL) - 2025 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company ended Q3 2025 with approximately $345 million in cash, not including about $445 million in net proceeds from an October equity financing [26] - The company has an expected cash runway into 2028, providing financial flexibility for ongoing clinical programs and potential commercialization [27] Business Line Data and Key Metrics Changes - The registrational programs for XPAXLY in Wet AMD and diabetic retinopathy are progressing well, with SOL1 on track for top-line data in Q1 2026 and SOLar reaching its target randomization of 555 subjects [28][29] - The SOL1 trial has over 95% patient retention, indicating strong engagement and compliance [15] Market Data and Key Metrics Changes - The global annual anti-VEGF market is estimated at approximately $15 billion, with significant opportunities for expansion due to high treatment discontinuation rates in Wet AMD and low treatment rates in diabetic retinopathy [9][10] - The company aims to capture a larger addressable market by reducing treatment burden and improving adherence, potentially reaching millions of untreated patients [11][28] Company Strategy and Development Direction - The company is focused on achieving a superiority label for XPAXLY, which could differentiate it from existing anti-VEGF therapies and insulate it from pricing pressures [7][8] - The strategy includes a triad approach: potential superiority, market expansion, and immediate adoptability, aiming to redefine the retina treatment landscape [27][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical strategy and market potential for XPAXLY, reinforced by positive feedback from payers and investors [26][27] - The company is committed to delivering long-lasting, clinically impactful therapies for retinal diseases, with a focus on early treatment to improve long-term outcomes [5][19] Other Important Information - The Helios program for diabetic retinopathy aims to pursue a broad label that encompasses both NPDR and DME, addressing a significant unmet need in the market [20][25] - The company has engaged with payers representing a large portion of U.S. commercial lives, receiving positive feedback on the potential of XPAXLY [14] Q&A Session Summary Question: What will the initial label for Wet AMD look like? - Management expects a superiority label based on SOL1, with flexibility for dosing intervals and repeat dosing [33][34] Question: What percentage of enrolled patients in Helios trials will have non-center-involved DME? - Management indicated confidence in achieving a broad label that includes all diabetic eye diseases based on previous study data [36][39] Question: What is the progress of NPDR studies? - Management confirmed that the process for NPDR studies began immediately after the recent financing, leveraging existing site relationships for efficient enrollment [56][59] Question: Are there risks associated with the ordinal two-step DRSS endpoint? - Management expressed great confidence in the ordinal endpoint, citing strong data from previous studies to support its validity [61][63] Question: How long will it take to complete enrollment for Helios 2? - Management believes there will be no issues in completing the trials efficiently due to high demand and enthusiasm from both patients and investigators [66]