• Total Net Revenue (Q4 2024): $11.6 million, compared to $14 million in Q4 2023.
• Net Product Revenue (Q4 2024): $0.8 million, compared to $0.7 million in Q4 2023.
• Net Revenue from Royalties and Collaborations (Q4 2024): $10.8 million, compared to $13.3 million in Q4 2023.
• Operating Expenses (Q4 2024): $56.8 million, compared to $30.4 million in Q4 2023.
• Net Loss (Q4 2024): $41.4 million or $0.64 per share, compared to $14.1 million or $0.33 per share in Q4 2023.
• Total Net Revenue (Full Year 2024): $43.3 million, compared to $46 million in 2023.
• Net Product Revenue (Full Year 2024): $3.2 million, compared to $14.2 million in 2023.
• Net Revenue from Royalties and Collaborations (Full Year 2024): $40.1 million, compared to $31.8 million in 2023.
• Operating Expenses (Full Year 2024): $189.1 million, compared to $121.1 million in 2023.
• Net Loss (Full Year 2024): $130.9 million or $2.32 per share, compared to $70.8 million or $1.82 per share in 2023.
• Cash and Investments (End of 2024): $371 million, compared to $331 million at the end of 2023.

• Warning! GuruFocus has detected 5 Warning Signs with EYPT.

Release Date: March 05, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• EyePoint Pharmaceuticals Inc (NASDAQ:EYPT) advanced its DURAVYU therapy into Phase 3 clinical trials for wet age-related macular degeneration (AMD) and reported positive Phase 2 results in diabetic macular edema (DME).
• The company has a strong safety profile for its Durasert technology, with over 190 patients treated with DURAVYU showing no serious adverse events.
• Enrollment in the Phase 3 wet AMD trials, LUGANO and LUCIA, is surpassing expectations, with LUGANO over 50% enrolled and LUCIA tracking ahead of schedule.
• EyePoint Pharmaceuticals Inc (NASDAQ:EYPT) ended 2024 with a robust balance sheet, holding $371 million in cash and investments, and no debt.
• The company's Northbridge manufacturing facility is operational, supporting DURAVYU registration batch manufacturing for an NDA filing.

Negative Points

• Total net revenue for the quarter ended December 31, 2024, decreased to $11.6 million from $14 million in the same period in 2023.
• Net product revenue is expected to remain immaterial as EyePoint Pharmaceuticals Inc (NASDAQ:EYPT) will no longer supply YUTIQ to ANI Pharmaceuticals after May 31, 2025.
• Operating expenses increased significantly to $56.8 million for the quarter ended December 31, 2024, primarily due to ongoing Phase 3 trials.
• The company reported a net loss of $41.4 million for the quarter, compared to a net loss of $14.1 million in the prior year period.
• EyePoint Pharmaceuticals Inc (NASDAQ:EYPT) does not plan to initiate a pivotal trial in DME until 2026, potentially delaying market entry for this indication.

Q & A Highlights

Q: For your wet AMD pivotal program, how many clinical sites have been activated across the trials of your overall target so far? A: We have most of the sites already activated in the US, especially the strong ones. In terms of ex-US, we are planning to have between 60 and 80 sites per study, which should be coming later this year. Currently, we have approximately 60 active sites per study. - Ramiro Ribeiro, Chief Medical Officer

Q: Can you comment on the analysis presented yesterday in the supplement, particularly the dose response between the 2.7 mg and 1.3 mg doses? A: The subgroup analysis of non-supplemented patients shows how powerful DURAVYU was in this DME population. We see evidence of dose response between the 2.7 mg and 1.3 mg doses. The 2.7 mg dose, which is used in pivotal trials, showed significant improvement. - Jay Duker, President, Chief Executive Officer

Q: Are you able to characterize the type of patients you are recruiting for the wet AMD trials? A: We have capped previously treated patients at approximately 25% in LUGANO, so the majority are treatment-naive. We don't expect to enroll more previously treated patients. - Jay Duker, President, Chief Executive Officer

Q: Have you considered any opportunities to conduct post-marketing studies for DURAVYU long term? A: Yes, we are considering post-approval studies, such as comparing DURAVYU against current industry leaders like high-dose Eylea or VABYSMO. We are also exploring additional benefits like prevention of atrophy in wet AMD patients. - Jay Duker, President, Chief Executive Officer and Ramiro Ribeiro, Chief Medical Officer

Q: Can you give more color on your plans to meet with US and ex-US agencies regarding the DME program? A: We plan to meet with both the FDA and EMA to gather regulatory feedback globally. The discussions will focus on the design of the study, aiming for an efficient approach. We expect to provide an update after receiving written minutes from these meetings. - Jay Duker, President, Chief Executive Officer and Ramiro Ribeiro, Chief Medical Officer

Q: Could you talk about the Northbridge manufacturing facility and any potential CMC issues? A: The Northbridge facility is a state-of-the-art 41,000 square foot site focused on clinical execution and commercial readiness. We have involved the FDA early in the design and execution, and we are prepared for registration batches and pre-approval inspections. - George Elston, Chief Financial Officer, Executive Vice President

Q: How would DURAVYU's potential every 6-month label compare to other potential treatments in the market? A: We believe an every 6-month label is preferred by physicians, offering flexibility to tailor treatment to maximize vision and minimize visits. DURAVYU is designed to deliver therapeutic levels consistently for 6 months. - Jay Duker, President, Chief Executive Officer

Q: What are the plans for initiating a Phase 3 trial in DME, and would you consider partnering for this indication? A: We currently have no plans to initiate a pivotal trial in DME in 2025, aiming for 2026. We would welcome a partner, but it would need to be part of a larger structured partnership. - Jay Duker, President, Chief Executive Officer

For the complete transcript of the earnings call, please refer to the full earnings call transcript.