Ocular Therapeutix(US:OCUL)2025-11-04 12:25Clinical Trials and Product Development - AXPAXLI is currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD) and plans to initiate a Phase 3 program for non-proliferative diabetic retinopathy (NPDR) imminently[113]. - The SOL-1 trial has randomized 344 subjects with a primary endpoint of maintaining visual acuity at Week 36, with over 95% retention rate among participants[120][121]. - The SOL-R trial has achieved its randomization target of 555 subjects, with topline data expected in the first half of 2027[127]. - The HELIOS-2 and HELIOS-3 trials for NPDR will evaluate AXPAXLI's efficacy using a novel ordinal primary endpoint, aiming for 6- and 12-month dosing intervals[135][136]. - AXPAXLI has the potential to be the first product for wet AMD with a superiority label compared to a single injection of anti-VEGF, with redosing potentially every 12 months[131]. - The SOL-1 trial is conducted under a special protocol assessment agreement with the FDA, with topline results expected in Q1 2026[121]. - The HELIOS-2 trial will include approximately 432 subjects, comparing AXPAXLI 450 μg to ranibizumab 0.3 mg, with a primary endpoint assessed at Week 52[138][140]. - The HELIOS-3 trial will involve approximately 930 subjects, comparing two dosing regimens of AXPAXLI to a sham comparator, with the same primary endpoint as HELIOS-2[141][143]. - The company plans to leverage the 505(b)(2) NDA review pathway for AXPAXLI, potentially shortening the review timeline by two months[131]. Financial Performance - The company reported net product revenue of $14.5 million for the three months ended September 30, 2025, a decrease of $0.8 million or 5.2% compared to $15.3 million for the same period in 2024[152]. - For the nine months ended September 30, 2025, net product revenue was $38.6 million, reflecting a decrease of $7.8 million or 16.8% from $46.4 million in the same period in 2024[152]. - The company reported a net loss of $201.3 million for the nine months ended September 30, 2025, compared to $193.5 million in 2024[218]. - The net loss for the three months ended September 30, 2025, was $69.4 million, compared to a net loss of $36.5 million for the same period in 2024, representing an increase of $32.9 million[174]. - The company anticipates continued increases in selling and marketing expenses as it supports the commercialization of DEXTENZA and prepares for the potential launch of AXPAXLI[204]. Research and Development Expenses - Research and development expenses increased by $15.3 million to $52.4 million for the three months ended September 30, 2025, compared to $37.1 million for the same period in 2024[174]. - Total research and development expenses for the nine months ended September 30, 2025, were $146.3 million, compared to $86.6 million in 2024, reflecting an increase of $59.7 million[196]. - Direct research and development expenses for products and candidates were $35.9 million for the three months ended September 30, 2025, compared to $18.2 million in 2024, an increase of $17.7 million[179]. - Direct research and development expenses for products and candidates were $96.2 million for the nine months ended September 30, 2025, compared to $42.0 million in 2024, an increase of $54.2 million[198]. - The company anticipates an increase in research and development expenses in the future as it supports the continued development of its product candidates[164]. Sales and Marketing - In-Market Sales for DEXTENZA were approximately 48,000 units in the three months ended September 30, 2025, an increase of approximately 6,000 units compared to the same period in 2024[154]. - Selling and marketing expenses rose to $13.1 million for the three months ended September 30, 2025, up from $10.6 million in 2024, reflecting a year-over-year increase of $2.5 million[181]. - Selling and marketing expenses increased to $41.0 million for the nine months ended September 30, 2025, up from $30.8 million in 2024, reflecting a year-over-year increase of $10.2 million[202]. Cash Flow and Liquidity - As of September 30, 2025, the company had cash and cash equivalents of $344.8 million and outstanding notes payable of $82.5 million under the Barings Credit Facility[214]. - The company raised approximately $445.4 million from the sale of 37,909,018 shares of common stock in October 2025[214]. - Cash provided by financing activities for the nine months ended September 30, 2025, was $112.3 million, a significant decrease from $327.6 million in the same period of 2024[234]. - The company has a total borrowing capacity of $82.5 million under the Barings Credit Facility, which has been fully drawn down[228]. - As of September 30, 2025, cash and cash equivalents totaled $344.8 million, indicating a strong liquidity position despite operational cash outflows[246]. Operating Expenses - Total costs and operating expenses for the three months ended September 30, 2025, were $83.2 million, an increase of $21.8 million from $61.4 million in the same period in 2024[174]. - The company expects to incur significant operating losses as it advances clinical trials for AXPAXLI, including the SOL-1 and SOL-R trials, and initiates new trials[219]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $150.6 million, compared to $95.2 million for the same period in 2024, reflecting an increase in operating expenses to $239.0 million[229][230]. - The net loss for the nine months ended September 30, 2025, was $201.3 million, attributed to increased operating expenses and partially offset by $38.7 million in net revenue[229]. - The company incurred non-cash adjustments of $40.8 million during the nine months ended September 30, 2025, primarily from stock-based compensation[229]. Interest and Other Financial Metrics - Interest income decreased to $3.7 million for the three months ended September 30, 2025, down from $5.7 million in 2024, a decrease of $2.0 million[187]. - Interest income decreased to $11.0 million for the nine months ended September 30, 2025, down from $15.6 million in 2024, a decline of $4.6 million year-over-year[208]. - Interest expense decreased to $9.0 million for the nine months ended September 30, 2025, compared to $10.5 million in 2024, reflecting a decrease of $1.5 million year-over-year[209]. - Total GTN Provisions for the three months ended September 30, 2025, were 52.5% of gross DEXTENZA product sales, up from 39.0% in the same period of 2024[176]. - GTN Provisions for the nine months ended September 30, 2025, were 51.4% of gross DEXTENZA product sales, up from 38.3% in 2024[192].