Ocular Therapeutix (OCUL) investor relations material

Executive summary

• Positive topline results from the Phase 3 SOL-1 trial for AXPAXLI in wet AMD, meeting primary and key secondary endpoints with statistical significance at Week 52 compared to aflibercept 2 mg; post-hoc analysis showed up to 72% reduction in treatment burden over 60 weeks.

• NDA submission for AXPAXLI in wet AMD planned for Q4 2026, following positive FDA Type C meeting confirming SOL-1 trial data as sufficient for submission; pre-NDA meeting scheduled for Q3 2026, with submission to follow 505(b)(2) pathway, potentially accelerating review by up to 60 days.

• Commercial readiness activities are accelerating ahead of a potential 2027 launch, with strong physician and payer interest based on SOL-1 data.

• Ongoing SOL-R and SOL-X trials for wet AMD and HELIOS-3 trial for diabetic retinopathy progressing, with topline SOL-R data expected Q1 2028; HELIOS-3 design streamlined to prioritize once-yearly dosing.

• DEXTENZA continues to generate modest revenue growth, with increased sales efforts targeting hospital outpatient departments.

Financial highlights

• Net product revenue was $13.5M for Q2 2026, up 0.7% year-over-year; $24.3M for the first half of 2026, up 1.3% year-over-year; DEXTENZA product revenue increased 0.6% over Q2 2025.

• Net loss for Q2 2026 was $78.8M, or $(0.35) per share, compared to $67.8M, or $(0.39) per share, in Q2 2025; net loss for the first half of 2026 was $167.4M.

• Research and development expenses increased to $54.1M in Q2 2026 (up $3.0M YoY), driven by clinical trial activity and manufacturing scale-up.

• Selling and marketing expenses rose to $17.3M in Q2 2026 (up $3.5M YoY), reflecting pre-commercial investments for AXPAXLI.

• Cash and cash equivalents totaled $598.6M as of June 30, 2026, with expected runway into 2028.

Outlook and guidance

• Existing cash is expected to fund planned operations, debt service, and capital expenditures into 2028, supporting ongoing trials and pre-commercial activities.

• Additional funding likely required for near-term commercialization of AXPAXLI if approved.

• Topline results from the SOL-R trial expected in Q1 2028, with amended endpoints to maximize label potential.

• Anticipated increases in operating expenses as clinical programs advance and commercialization efforts expand.