Ocular Therapeutix (OCUL) Q1 2026 earnings summary

Executive summary

• AXPAXLI demonstrated statistical superiority and unmatched durability over aflibercept in Phase 3 SOL-1 for wet AMD, maintaining vision in two-thirds of patients for a year with a single injection.

• Enrollment began for the SOL-X long-term extension trial, while SOL-R completed randomization ahead of schedule and will provide topline data in Q1 2027.

• HELIOS-3 Phase 3 trial in diabetic retinopathy is ongoing, aiming for a broad label across diabetic retinal disease.

• NDA submission for AXPAXLI in wet AMD is planned based on SOL-1 Week 52 data, leveraging the 505(b)(2) pathway for a potentially shortened review and accelerated commercial readiness.

• Investor Day scheduled for June 17, 2026, will provide regulatory, clinical, and commercialization updates.

Financial highlights

• Ended Q1 2026 with $666.7 million in cash and cash equivalents, expected to provide runway into 2028, supporting NDA submission, ongoing trials, and commercial preparations.

• Net product revenue for Q1 2026 was $10.8 million, up slightly year-over-year, driven by DEXTENZA sales.

• Net loss for Q1 2026 was $(88.6) million, reflecting increased R&D and SG&A expenses.

• Research and development expenses rose to $66.2 million from $42.9 million year-over-year, mainly due to clinical trial progression.

• Weighted average shares outstanding increased to 224.1 million from 169.4 million year-over-year.

Outlook and guidance

• Sufficient cash to fund operations into 2028, including planned NDA submission for AXPAXLI.

• Expect continued increases in R&D, SG&A, and pre-commercialization expenses for AXPAXLI and ongoing trials.

• SOL-R topline data expected in Q1 2027; HELIOS-3 update planned for June 2026 Investor Day.