Ocular Therapeutix(OCUL) - 2025 Q3 - Quarterly Results

Financial Performance - Total net revenue for Q3 2025 was $14.5 million, a 5.8% decrease from $15.4 million in Q3 2024[6] - The net loss for Q3 2025 was $(69.4) million, or $(0.38) per share, compared to a net loss of $(36.5) million, or $(0.22) per share, in Q3 2024[11] - Total revenue for the three months ended September 30, 2025, was $14,544 million, a decrease of 5.2% compared to $15,425 million for the same period in 2024[42] - Product revenue, net for the nine months ended September 30, 2025, was $38,573 million, down 16.9% from $46,441 million in 2024[42] - The net loss for the three months ended September 30, 2025, was $69,418 million, compared to a net loss of $36,493 million for the same period in 2024[42] - Net loss per share, basic, for the three months ended September 30, 2025, was $0.38, compared to $0.22 for the same period in 2024[42] - Total costs and operating expenses for the three months ended September 30, 2025, were $83,242 million, an increase of 35.5% from $61,423 million in 2024[42] - Collaboration revenue for the three months ended September 30, 2025, was negligible at $0 million, down from $78 million in 2024[42] - Interest income for the three months ended September 30, 2025, was $3,729 million, a decrease of 34.0% from $5,653 million in 2024[42] - Total other income (expense), net, for the three months ended September 30, 2025, was $(720) million, a significant decrease from $9,505 million in 2024[42] Expenses - Research and development expenses for Q3 2025 were $52.4 million, up from $37.1 million in Q3 2024, reflecting increased clinical trial costs[8] - Selling and marketing expenses rose to $13.1 million in Q3 2025, compared to $10.6 million in Q3 2024, due to expanded marketing efforts for AXPAXLI[9] - General and administrative expenses increased to $16.0 million in Q3 2025 from $12.2 million in Q3 2024, primarily due to higher personnel-related costs[10] - Research and development expenses increased significantly to $52,358 million for the three months ended September 30, 2025, compared to $37,054 million in 2024, reflecting a 41.2% increase[42] Cash and Assets - Cash balance as of September 30, 2025, was $344.8 million, with an additional $445 million in net proceeds from an equity offering completed on October 1, 2025, providing a runway into 2028[3][5] - The company reported total current assets of $386,980,000 as of September 30, 2025, a decrease of 12.2% from $440,987,000 on December 31, 2024[40] - The company has a cash balance of $344,772,000 as of September 30, 2025, down from $392,102,000 on December 31, 2024, representing a decrease of 12.1%[40] Liabilities and Deficit - Total liabilities increased to $152,653,000 as of September 30, 2025, compared to $142,591,000 on December 31, 2024, reflecting a rise of 7.5%[40] - The accumulated deficit grew to $(1,092,369,000) as of September 30, 2025, up from $(891,084,000) on December 31, 2024, indicating a significant increase in losses[40] Clinical Trials and Product Development - The SOL-1 Phase 3 trial for AXPAXLI is on track to report topline data in Q1 2026, with over 95% retention of randomized subjects[4] - The SOL-R Phase 3 trial achieved its target randomization of 555 subjects and is expected to report topline data in 1H 2027[1][4] - The HELIOS registrational program for AXPAXLI in diabetic retinopathy is set to begin imminently, utilizing a novel primary endpoint agreed upon with the FDA[7] - AXPAXLI is currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD) and plans to initiate a Phase 3 clinical program for non-proliferative diabetic retinopathy (NPDR) imminently[34] - The primary endpoint of the HELIOS-2 trial is the ordinal DRSS 2-step change status at Week 52 from baseline, with approximately 432 subjects participating[26][25] - The HELIOS-3 trial will involve approximately 930 subjects and is designed as a three-arm study to evaluate the safety and efficacy of AXPAXLI[27] - The SOL-X trial aims to evaluate long-term safety and efficacy of AXPAXLI in wet AMD over a 36-month period[21] Product Sales - DEXTENZA end-user unit sales grew by 9.7% in Q3 2025, with net product revenue increasing by 8.5% compared to the previous quarter[6] - The company’s product DEXTENZA is FDA-approved for treating ocular inflammation and pain, contributing to its revenue stream[35] - The company anticipates potential regulatory submissions and approvals for its product candidates, including AXPAXLI, OTX-TIC, and others[37]