Ocular Therapeutix(OCUL) - 2023 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company reported a net loss of $0.5 million for Q3 2023, a significant improvement compared to a net loss of $24.2 million in Q3 2022 [76] - Total net revenue for Q3 2023 was $15.1 million, representing a 26% increase from $12 million in Q3 2022 [85] - Research and development expenses increased to $15 million in Q3 2023 from $13.7 million in Q3 2022, driven by clinical trial costs and personnel-related expenses [75] Business Line Data and Key Metrics Changes - DEXTENZA net product revenue reached $15 million in Q3 2023, a 26% increase from $11.9 million in Q3 2022 [14][86] - Units sold for DEXTENZA increased by 38% year-over-year, totaling 36,902 units in Q3 2023 [45] - The company anticipates DEXTENZA's full-year net product revenue to be at the upper end of the $55 million to $60 million range [15][79] Market Data and Key Metrics Changes - The company noted a significant increase in customer order sizes, with 49% of DEXTENZA orders being for 30 or more units in Q3 2023, compared to 29% in Q3 2022 [46] - The FDA's new draft guidance is expected to impact the development of treatments in wet AMD, particularly for products like AXPAXLI that demonstrate extended durability [12][26] Company Strategy and Development Direction - The company is focused on the commercialization of AXPAXLI, an axitinib-containing implant for wet AMD, and has received FDA agreement on a special protocol assessment for its pivotal trial [9][10] - AXPAXLI is positioned to potentially change the standard of care in the wet AMD market, which is valued in the billions [11] - The company is also advancing its OTX-TIC program for glaucoma treatment, aiming to improve patient compliance and outcomes [38][40] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth trajectory of DEXTENZA, citing clinical efficacy and safety as key drivers [63] - The company remains confident in its long-term prospects despite CMS's decision not to change the status indicator for DEXTENZA's insertion procedure [72] - Management highlighted the importance of strong endorsements from the retina community for AXPAXLI's success [14] Other Important Information - The company had $110.6 million in cash and cash equivalents as of September 30, 2023, providing a runway into 2025 [77] - The company plans to share topline data from the HELIOS trial for AXPAXLI in Q2 2024 [37] Q&A Session Summary Question: What is the plan for enrolling patients with 20/20 vision? - Management confirmed that the plan remains to enroll patients who achieve 20/20 vision after induction with ILEA, and they believe there is a sizable population available for enrollment [49] Question: What data is needed to move forward with the Phase 3 trial for diabetic retinopathy? - Management expects to see a trend in improvement in the DRSS score to proceed with the Phase 3 trial [54] Question: How does the new formulation of AXPAXLI compare to the previous one? - The new formulation has a lower drug load of 450 micrograms but is designed to release the drug faster, matching the delivery seen in earlier trials [102] Question: What percentage of the wet AMD population fits the current enrollment criteria? - Management indicated that the current criteria are designed to capture a significant portion of the treatment-naive wet AMD population [117] Question: What are the expectations for the safety profile of the new formulation? - Management expressed confidence that the safety profile will remain consistent with previous formulations, as the delivery rates are within the safety window [135]