OCULAR THERAPEUTIX, INC Q2 FY2023 earnings call

• DEXTENZA achieved $15 million in net product revenue in Q2 2023, with 24% year-over-year growth and 14% sequential growth.
• The company plans to initiate the first pivotal trial for OTX-TKI before the end of Q3 2023 using a superiority design.
• OTX-TKI's Phase 1 HELIOS trial for non-proliferative diabetic retinopathy completed enrollment, with interim data expected in Q1 2024.
• OTX-TIC's Phase 2 program for glaucoma completed enrollment, with top-line data anticipated in Q1 2024.
• For dry eye programs, a small study was initiated in Q2 to evaluate OTX-DED versus placebo inserts to inform future clinical trials.
• Commercially, DEXTENZA's in-market unit volume grew, and efforts are underway to secure facility payment for CPT 68841.

In the second quarter of 2023, DEXTENZA contributed significantly to the company's revenue. DEXTENZA net product revenue was $15 million for Q2 2023, which is a 24% increase compared to the same quarter in 2022 and a 14% sequential growth from Q1 2023. This $15 million represents a substantial portion of the total net revenue of $15.2 million for the quarter.

• DEXTENZA net product revenue guidance for 2023 has been revised to the upper end of the $55 million to $60 million range.
• Plan to initiate the first pivotal trial for OTX-TKI in wet AMD before the end of Q3 2023.
• Interim data from the OTX-TKI HELIOS trial is expected in Q1 2024, and top-line data from the OTX-TIC Phase 2 trial is anticipated in Q1 2024.

• Uncertainty in clinical trial outcomes for OTX-TKI and other pipeline programs.
• Regulatory challenges in obtaining approvals for new products.
• Dependence on successful commercialization of DEXTENZA and other pipeline products.
• Risks related to financing and potential dilution.

Q: Dane Leone asked about the Phase 3 trial protocol for OTX-TKI in wet AMD and avoiding conflict with Eylea's label.

A: Antony Mattessich referred Rabia Ozden to discuss the change in FDA guidance and plans for a superiority design instead of non-inferiority with sham injections.

Q: Jon Wolleben inquired about the formulation and feasibility of the diabetic retinopathy trial.

A: Antony Mattessich and Rabia Ozden mentioned focusing on wet AMD as the primary priority and pending further financing for diabetic retinopathy.

Q: Joe Catanzaro asked about trial design and loading doses.

A: Rabia Ozden and Antony Mattessich discussed the careful design considering patient safety and physician acceptability.

Q: Colleen Kusy asked about trial design discussions with FDA and enrollment timelines.

A: Rabia Ozden and Antony Mattessich stated extensive FDA discussions and expectations of relatively quick enrollment.

Q: Kelly Shi asked about the second wet AMD trial design and FDA discussions.

A: Rabia Ozden confirmed the second trial would have the same design and ongoing FDA communications.

Q: Tara Bancroft asked about primary endpoint time and patient enrollment.

A: Rabia Ozden discussed the durability design and patient enrollment considerations.

Q: Chaitanya G asked about the second pivotal trial timeline and dry eye program.

A: Rabia Ozden mentioned ongoing work on dry eye placebo and plans to start the second pivotal trial based on first trial outcomes.

Q: Caroline Palomeque asked about the cost of pivotal trials.

A: Antony Mattessich stated approximately $50 million per pivotal trial for OTX-TKI