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 around $445 million in net proceeds from an October equity financing [25] - The financial strength provides the company with a cash runway into 2028, allowing for flexibility in pursuing clinical programs and preparing for commercialization [26] 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 [27][28] - The Helios program for diabetic retinopathy is designed to capture a broad label, addressing both NPDR and DME, with a focus on early treatment to prevent disease progression [19][24] Market Data and Key Metrics Changes - The global annual anti-VEGF market is estimated at approximately $15 billion, with significant opportunities for expansion as many patients remain untreated [8] - In Wet AMD, up to 40% of patients discontinue therapy within the first year, highlighting a substantial market opportunity for XPAXLY to improve adherence and reduce treatment burden [9] Company Strategy and Development Direction - The company aims to redefine the retina experience through a strategic triad: potential superiority label, market expansion, and immediate adoptability of XPAXLY [5][27] - The focus is on achieving a superiority label that distinguishes XPAXLY from existing anti-VEGF therapies, potentially insulating it from pricing pressures and enhancing market dynamics [6][7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical strategy and market potential of XPAXLY, reinforced by positive feedback from payers and investors [25][26] - The company is committed to delivering long-lasting, clinically impactful therapies for retinal diseases, with a focus on reducing treatment burden and improving patient outcomes [4][12] Other Important Information - The company has engaged with payers representing over 75% of U.S. commercial lives, receiving positive feedback on the potential of XPAXLY to deliver meaningful clinical differentiation [13] - The SOL1 trial has achieved over 95% patient retention, indicating strong engagement and compliance within the study [14] Q&A Session Summary Question: How is the initial label for Wet AMD expected to look? - Management anticipates a superiority label based on SOL1, with flexibility for dosing intervals and repeat dosing [32][33] Question: What percentage of enrolled patients in Helios trials will have non-center-involved DME? - Management indicated that they do not have specific percentages yet but expressed confidence in obtaining a broad label that includes all diabetic eye disease [35][38] Question: What is the progress of the SOLar study? - Management reported that SOLar has reached its target randomization of 555 patients, with a focus on thoughtful patient selection to ensure stability [40][43] Question: What details will be shared in the SOL1 top line? - Management stated that the primary goal of SOL1 is to achieve a superiority label, and they will provide data that supports confidence in the success of SOLar [47][49] Question: How will the NPDR studies be accelerated? - Management noted that they are leveraging existing site relationships and expertise to ensure efficient enrollment and execution of the NPDR studies [51][52] 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 [57][59]