Ocular Therapeutix (OCUL) Q3 2026 earnings summary

Executive summary

• AXPAXLI met SOL-1’s Week 36 superiority primary endpoint and Week 52 key secondary endpoint; wet AMD NDA submission remains planned for Q4 2026 under the FDA-aligned 505(b)(2) pathway.

• Q3 revenue was $12.9M and net loss was $94.8M; cash and cash equivalents totaled $530.6M at September 30, 2026.

• Current resources are expected to fund planned operations into 2028, excluding full anticipated manufacturing and commercial scale-up costs.

Financial highlights

• Q3 2026 revenue was $12.9M versus $14.5M YoY; operating loss was $97.9M versus $68.7M, and net loss was $94.8M versus $69.4M.

• 9M 2026 revenue was $37.1M versus $38.7M; operating loss was $273.3M versus $200.3M, and net loss was $262.2M versus $201.3M.

• Q3 / 9M operating expenses were $110.7M / $310.4M, including R&D of $74.8M / $195.1M; Q3 selling and marketing was $15.7M and G&A was $18.8M.

• Q3 / 9M loss per share was $0.42 / $1.17, versus $0.38 / $1.15 in 2025.

Outlook and guidance

• Planned Q4 2026 NDA package includes SOL-1 Week 52 efficacy, SOL-1 and interim SOL-R Week 52 safety, and confirmatory evidence; repeat-dosing data are intended to support the label if approved.

• The planned NDA safety database will include more than 300 patients with at least one year of follow-up; interim SOL-R safety analysis is expected in Q4 2026.

• SOL-R remains masked through Week 96, with topline results expected in Q1 2028; efficacy data are not required for the planned U.S. NDA.

• DEXTENZA unit sales are expected to grow incrementally through the rest of 2026 and beyond, with gross-to-net provisions expected to stabilize.

• R&D, selling and marketing, and G&A expenses are expected to increase with trials, NDA preparation, manufacturing scale-up, and launch planning; additional funding may be needed for AXPAXLI scale-up if approved.