EyePoint Pharmaceuticals, Inc. Q1 FY2025 earnings call

• DURAVYU is advancing through late-stage clinical development with strong enrollment in global Phase 3 trials LUGANO and LUCIA for wet AMD, with over 90% randomized in LUGANO and over 50% in LUCIA.
• DURAVYU is a differentiated sustained release TKI with broader VEGF inhibition and potential to reduce fibrosis, supported by robust Phase I and II data sets.
• Manufacturing facility in Northbridge, Massachusetts is operational and can produce over 1 million DURAVYU treatments annually.
• DURAVYU met primary and secondary endpoints in Phase 2 VERONA trial for DME, showing compelling efficacy and durability, with DME being a $3 billion market opportunity by 2030.

For the quarter ended March 31, 2025, total net revenue was $24.5 million compared to $11.7 million in the corresponding period of 2024. Net product revenue for Q1 2025 was $0.7 million, consistent with Q1 2024. Net revenue from royalties and collaborations for Q1 2025 was $23.7 million, up from $11 million in Q1 2024, primarily due to recognition of remaining deferred revenue from the out-license of YUTIQ US rights in 2023. Operating expenses for Q1 2025 were $73.3 million, up from $45 million in Q1 2024, driven by ongoing Phase 3 trials for DURAVYU. Cash, cash equivalents, and investments in marketable securities on March 31, 2025, totaled $318.2 million, down from $371 million on December 31, 2024.

• Guiding to full enrollment in Phase 3 LUGANO and LUCIA trials in the second half of 2025.
• Anticipating top-line data for Phase 3 trials in the second half of 2026.
• Planning end-of-Phase 2 meeting with FDA for DME program in summer.

• Factors that could materially affect forward-looking statements, including regulatory matters, clinical trial outcomes, and supply chain issues.
• Uncertainties in clinical development and regulatory approvals for DURAVYU.

Q: Yi Chen asked about baseline patient characteristics in Phase 3 trials.

A: Amir Panush explained baseline patient characteristics are based on FDA requirements for active wet AMD patients with specific vision and OCT criteria.

Q: Yigal Nochomovitz asked about NDA filing timing and supply chain.

A: Ramiro Ribeiro stated confidence in being first to file due to enrollment rates and trial design, and Jay Duker mentioned API and inserts manufactured in US with state-of-the-art facility in Northbridge for commercial supply.