OCULAR THERAPEUTIX, INC Q3 FY2023 earnings call

AXPAXLI Program - Received special protocol assessment (SPA) from the FDA, on track to enroll first subject by end of 2023. The trial is a prospective multi-center randomized parallel group pivotal Phase 3 trial comparing AXPAXLI to aflibercept in wet AMD. ### DEXTENZA - Recorded net product revenue of $15 million in Q3 2023, 26% higher than Q3 2022. Market unit volume saw a 38% increase in units sold to ambulatory surgery centers and hospital outpatient departments. ### Other Pipeline Programs - OTX-TIC Phase 2 trial enrollment complete, with topline results expected in April 2024; sub-study on repeat dosing progressing. HELIOS trial for AXPAXLI in diabetic retinopathy completed enrollment, with interim nine-month data expected in Q2 2024. OTX-TED and OTX-CSI enrollment going well for dry eye programs.

In the third quarter of 2023, DEXTENZA contributed significantly with net product revenue of $15 million, which is a 26% increase compared to the same quarter in 2022. DEXTENZA's revenue contribution is a key part of the company's financials for the quarter.

DEXTENZA - Reaffirms full-year 2023 net product revenue guidance in the range of $55 million to $60 million, expecting to be at the upper end. ### Pipeline - Plans to present topline data from OTX-TIC Phase 2 in April 2024 and interim nine-month data from HELIOS trial in Q2 2024. ### Events - Hosting an R&D day in December to detail OTX-TIC pivotal program and pipeline.

Regulatory and Trial Risks - Uncertainties related to clinical trial outcomes, potential differences between trial results and real-world performance, and regulatory approval processes. ### Financial Risks - Variability in revenue from DEXTENZA and uncertainties in funding for pipeline programs, as outlined in Form 10-Q and 10-K filings.

Q: Without the CMS facility decision, what can accelerate DEXTENZA's growth in the surgical setting in 2024?

A: Steve Meyers mentioned they will revisit the CMS status indicator decision in 2025 and remain hopeful for change.

Q: What percentage of the wet AMD population fits AXPAXLI's enrollment criteria?

A: Rabia Ozden stated the population includes treatment-naive wet AMD subjects with good visual acuity who may not be eligible for other trials.

Q: How does the 450 microgram formulation of AXPAXLI compare to the phase one study?

A: Antony Mattessich explained it's a change in load from 600 micrograms to 450 micrograms, optimizing drug release to match bioresorption.

Q: What are expectations for subject drop-offs in the AXPAXLI trial?

A: Antony Mattessich mentioned the FDA clarified that patients with 15 letter loss or protocol violations will be reviewed in totality, and dropouts will be considered in intent-to-treat analysis.