OCULAR THERAPEUTIX, INC Q4 FY2024 earnings call

• 2024 was a transformational year for Ocular Therapeutix, focusing on redefining the retina experience with AXPAXLI as the top priority for wet AMD. • Received FDA approval for an amendment to the special protocol agreement for SOL-1 to incorporate redosing at weeks 52 and 76, potentially unlocking a six to 12-month dosing label. • SOL-1 completed randomization in December 2024 with 344 subjects, retention is exceptional, and rescue treatments are in line with protocol. • SOL-R is streamlined from 825 to 555 subjects due to SOL-1 redosing amendment, accelerating timeline and maintaining statistical power. • AXPAXLI shows potential in non-proliferative diabetic retinopathy and diabetic macular edema, with proof-of-concept HELIOS trial results. • Strong financial position with $392M cash as of December 31, 2024, no immediate plan to raise capital.

No detailed financial performance by product segment with revenue contribution % provided in the transcript.

• Expect SOL-1 topline data in Q1 2026. • SOL-R timeline accelerated with reduced sample size. • Plan to submit NDA after SOL-R 56-week primary endpoint. • No immediate plan to raise additional capital this year.

No specific risks discussed in detail during the call; risks are as identified in the company's annual report on Form 10-K and other SEC filings.

Q: Given the stats on SOL-1 patient retention and redosing rates, why make changes now?

A: SOL-1 and SOL-R are complementary trials. FDA approved redosing amendment for SOL-1, and strong retention allows efficiency gains, potentially getting AXPAXLI to patients faster with better label.

Q: Rationale for dosing at week 76 in SOL-1?

A: To maximize drug exposure to patients and satisfy FDA safety requirements. All patients in SOL-1 receive redosing at weeks 52 and 76 with original randomized drug.

Q: Why reduce SOL-R size?

A: Due to SOL-1 redosing amendment satisfying safety requirements, allowing reduction from 825 to 555 subjects while maintaining statistical significance.

Q: Do changes to SOL-1 and SOL-R increase confidence in performance targets?

A: Confidence is higher than ever, with company aligned to ensure success of both trials.

Q: FDA expectations for SOL-R rescues?

A: Rescue criteria in line with traditional guidelines, and rescues will be evaluated in context of positive SOL-1 study.

Q: Timeline for NPDR and DME clinical trials?

A: Expect FDA feedback in first half of 2025, with trial design dependent on feedback, and no immediate plan for additional funding.

Q: Expectations for patients showing durability to 52 weeks in SOL-1?

A: Confident in a significant percentage of patients showing durability to 52 weeks, based on US study data where 60% of non-enriched patients went that long.