EyePoint Pharmaceuticals, Inc. Q2 FY2025 earnings call

• Pivoted to clinical stage biopharmaceutical, focusing on DURAVYU for wet-AMD and DME.
• Completed 4 clinical trials for DURAVYU, treating over 190 patients, with robust safety profile and Phase II efficacy data showing non-inferior visual acuity vs aflibercept with >80% reduction in treatment burden.
• Enrolled over 800 patients in Phase III LUGANO and LUCIA trials for wet-AMD, expecting top line LUGANO data mid-2026 and LUCIA shortly after.
• Positive Phase II VERONA trial results in DME, supporting pivotal program.
• Built state-of-the-art cGMP manufacturing facility in Massachusetts.
• Transformed balance sheet, eliminating debt and extending cash runway to 2027.

For the quarter ended June 30, 2025, total net revenue was $5.3 million compared to $9.5 million in Q2 2024. Net revenue from license and royalties in Q2 2025 was $5.3 million vs $8.4 million in Q2 2024, driven by lower deferred revenue from exiting Specialty Pharma. Operating expenses in Q2 2025 were $67.6 million vs $44 million in Q2 2024, primarily due to increased clinical trial costs for DURAVYU Phase III trials. Cash and investments ended Q2 2025 at $256 million.

• Affirmed cash runway guidance, expecting cash to support operations into 2027 beyond key data readouts in 2026.
• Anticipate top line LUGANO data mid-2026 and LUCIA shortly after.
• Plan to file NDA and aim for launch in 2027 if trials are successful.

• Forward-looking statements may not materialize due to factors in the Risk Factors section of the 10-K.
• Risks associated with trial conduct, including potential protocol deviations and safety monitoring challenges.
• Uncertainty around rescue criteria interpretation and its impact on trial results.

Q: Speak to overall trial conduct of pivotal studies in wet-AMD and mitigating risks A: Ramiro Ribeiro discussed focus on study conduct, close collaboration with sites/investigators, tracking safety, and strong execution with low dropout rate Q: Concerns about introducing bias in masked data and safety updates A: Jay Duker and Ramiro Ribeiro addressed that masked demographics are fine, but avoiding bias; periodic safety updates planned Q: Elaborate on rescue criteria in trials and alignment with real world A: Jay Duker explained strict rescue criteria based on data, avoiding physician discretion, and focus on true site-threatening hemorrhages Q: Baseline of naive vs exposed patients and rescue rates A: Jay Duker noted assumption naive patients may have lower rescue rates than previously treated 'frequent flyers' in Phase II Q: Blended endpoint in trials and filing pathway A: Jay Duker explained blended endpoint was agency-suggested, derisking, and discussed potential filing advantages including short savings with drug-device combo Q: Regulatory plans and safety package for NDA A: Ramiro Ribeiro and Jay Duker discussed data soundness, NDA preparation, safety database meeting FDA requirements with over 400 patients across trials Q: Advantage of traditional filing vs 505(b)(2) pathway A: Jay Duker mentioned potential 2-month savings with 505(b)(2) but emphasized confidence in first-to-file Q: Open-label extension study and pivotal trial progress updates A: Jay Duker confirmed plan for open-label extension, with periodic updates on pivotal trial progress Q: LUCIA trial patient distribution and ex-U.S. interest A: Jay Duker stated ~80% U.S. and ~20% ex-U.S. patients, with strong interest in ex-U.S. for sustained release option Q: DSMB meetings and future revenue A: Ramiro Ribeiro said DSMB meets every 6 months, and future revenue expected to be de minimis as transitioned to clinical stage