Ocular Therapeutix — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total net revenue was $12.9 million for the third quarter of 2026, a decrease from $14.5 million in the comparable quarter of 2025.
• Product revenue, net was $12.9 million for the third quarter of 2026, down from $14.5 million in the prior year period.
• Research and development expenses were $74.8 million for the third quarter of 2026, an increase from $52.4 million in the comparable quarter of 2025.
• Selling and marketing expenses were $15.7 million for the third quarter of 2026, up from $13.1 million in the comparable quarter of 2025.
• General and administrative expenses were $18.8 million for the third quarter of 2026, compared to $16.0 million in the comparable quarter of 2025.
• Net loss for the third quarter of 2026 was $94.8 million, or $0.42 per share (basic and diluted), compared to a net loss of $69.4 million, or $0.38 per share, in the comparable quarter of 2025.
• Cash and cash equivalents were $530.6 million as of September 30, 2026, down from $737.1 million as of December 31, 2025.
• Notes payable, net were $73.5 million as of September 30, 2026, compared to $71.3 million as of December 31, 2025.
• Deferred revenue remained constant at $14.0 million as of September 30, 2026, and December 31, 2025.
• Total stockholders' equity was $440.9 million as of September 30, 2026, compared to $654.3 million as of December 31, 2025.

Guidance and Future Outlook:

• The AXPAXLI New Drug Application (NDA) submission for wet AMD is on track for the fourth quarter of 2026.
• The NDA will be submitted under the 505(b)(2) regulatory pathway, which the company believes could shorten the FDA review timeline by up to 60 days compared to the traditional 505(b)(1) pathway.
• An interim Week 52 safety analysis for the SOL-R trial is expected to be conducted in the fourth quarter of 2026, with results included in the NDA submission.
• The SOL-R primary endpoint has been moved to Week 40, with topline results expected in the first quarter of 2028.
• The company expects its cash balance to support operating expenses, debt service, and capital expenditures into 2028.
• Commercial readiness activities are accelerating, including investments in commercial infrastructure, market access planning, and launch execution capabilities in anticipation of a potential U.S. launch.

Business Segments and Product Lines:

• AXPAXLI (OTX-TKI) is the primary investigational product candidate for wet AMD and diabetic retinal diseases, currently in Phase 3 trials.
• The SOL-1 Phase 3 trial for wet AMD demonstrated superiority to aflibercept (2 mg) at Week 52, with 65.9% of AXPAXLI-treated subjects maintaining vision compared to the aflibercept arm.
• The SOL-R Phase 3 trial for wet AMD has completed randomization of 640 subjects and utilizes a patient enrichment strategy to exclude subjects with early persistent fluid or fluid variability.
• Preliminary analysis of SOL-R screening indicates approximately 20% of otherwise eligible subjects were excluded due to early persistent retinal fluid or fluid variability.
• The SOL-X open-label extension trial continues enrollment with plans to implement a 48-week dosing interval based on durability data from SOL-1.
• The HELIOS-3 Phase 3 trial for non-proliferative diabetic retinopathy (NPDR) is progressing, with enrollment of approximately 620 patients evaluating AXPAXLI dosed every 12 months versus sham.
• DEXTENZA remains the company's commercial product, generating the majority of current revenue.
• OTX-TIC, an investigational travoprost intracameral hydrogel for glaucoma, has completed a Phase 2 trial, with next steps currently being evaluated.

Market and Competitive Landscape:

• AXPAXLI is positioned as the only intravitreal sustained-release maintenance agent with positive Phase 3 data in wet AMD.
• The company notes that frequent injections define the current wet AMD treatment experience, creating a market opportunity for AXPAXLI to reduce treatment burden.
• Recent clinical results from peers underscore the importance of molecular potency, sustained durability, and thoughtful clinical trial design.
• Market research indicates strong physician interest in AXPAXLI's profile based on SOL-1 data alone.

Risks and Challenges:

• The safety and efficacy profile of AXPAXLI has not been established by the FDA or any other regulatory authority.
• There is uncertainty regarding whether the FDA will accept the NDA based on a single pivotal clinical trial or agree to the 505(b)(2) pathway.
• Risks include potential disagreements with the FDA regarding trial design, statistical analysis plans, or the minimum clinical data required for safety.
• The company faces risks related to the timing and costs of commercialization, including manufacturing capacity scaling and commercial team expansion.
• Uncertainty exists regarding the potential impact of most-favored-nation and reference pricing regimes on commercial potential outside the United States.
• The company has existing indebtedness, and creditors may accelerate maturity upon certain events of default.

Management Commentary and Tone:

• Executive Chairman, President, and CEO Pravin U. Dugel, MD, described 2026 as a "transformational year" and expressed strong confidence in the likelihood of SOL-R's success.
• Dr. Dugel highlighted that approximately 70% of subjects quantitatively dry at Week 8 in SOL-1 remained dry through Week 36 following a single injection.
• Dr. Dugel noted that subjects with early persistent fluid in SOL-1 had worse visual outcomes and required supplemental injections 32 weeks earlier than those without such fluid.
• Chief Development Officer Peter K. Kaiser, MD, stated that confidence in the trial's success and AXPAXLI's potential to reduce treatment burden has never been greater.
• Management emphasized the strategic value of the 505(b)(2) pathway and the alignment with the FDA on the submission package.

Other Key Points:

• Ocular Therapeutix appointed Riad Sherif, MD, to its Board of Directors, effective immediately, bringing extensive global commercial experience from Alcon, Novartis, Sanofi, and Oculis.
• Dr. Sherif will overlap with current board member Seung Suh Hong, PhD, until the end of 2026, at which point Dr. Hong will step down.
• The company plans to submit data from subjects who received multiple AXPAXLI injections in both Phase 3 trials to support the inclusion of repeat dosing on the label, if approved.
• The aggregate safety dataset for the NDA will include more than 300 patients with at least one year of follow-up after AXPAXLI treatment.
• Outstanding shares as of November 6, 2026, were approximately 220.0 million.