Ocular Therapeutix(OCUL)2025-05-05 11:47Clinical Trials and Regulatory Outlook - AXPAXLI is currently in two Phase 3 clinical trials for wet AMD, with the SOL-1 trial having randomized 344 subjects as of December 2024[101][102]. - The SOL-1 trial aims to assess the safety and efficacy of AXPAXLI compared to aflibercept, with a primary endpoint of maintaining visual acuity at Week 36[101][106]. - The SOL-R trial, initiated in June 2024, plans to enroll approximately 555 subjects and has a primary endpoint of non-inferiority in mean change in BCVA at Week 56[107][109]. - The FDA agreed that the SOL-R trial should support a potential NDA for AXPAXLI, indicating a favorable regulatory outlook[108]. - The company plans to submit an NDA for AXPAXLI for wet AMD if favorable results are obtained from the SOL-1 and SOL-R trials[109]. - The company is actively planning next steps for AXPAXLI in treating NPDR and DME following positive FDA feedback on trial design[110]. Financial Performance - DEXTENZA's net product revenue for Q1 2025 was $10.6 million, a decrease of $4.1 million or 27.7% compared to Q1 2024, attributed to pricing strategy impacts[113]. - Product revenue decreased to $10.6 million for the three months ended March 31, 2025, down from $14.7 million in the same period of 2024, reflecting a decline of $4.1 million year-over-year[135]. - The company reported a net loss of $64.1 million for the three months ended March 31, 2025, compared to a net loss of $64.8 million in the same period of 2024, an improvement of $0.8 million[134]. - The company incurred net losses of $64.1 million for the three months ended March 31, 2025, and accumulated a deficit of $955.1 million as of the same date[158][159]. - Cash used in operating activities was $44.7 million for the three months ended March 31, 2025, primarily due to operating expenses of $74.6 million[168]. Expenses and Cost Management - Research and development expenses increased significantly to $42.9 million for the three months ended March 31, 2025, compared to $20.7 million in 2024, marking an increase of $22.1 million[139]. - Selling and marketing expenses rose to $14.1 million for the three months ended March 31, 2025, up from $10.2 million in 2024, an increase of $3.9 million[144]. - General and administrative expenses increased to $16.3 million for the three months ended March 31, 2025, compared to $14.1 million in 2024, reflecting a rise of $2.2 million[146]. - The company anticipates that research and development expenses will continue to increase significantly for the remainder of 2025 and beyond as it progresses with ongoing clinical trials[142]. Cash and Financing - As of March 31, 2025, the company had cash and cash equivalents of $349.7 million and outstanding notes payable of $82.5 million under the Barings Credit Facility[154]. - The company plans to fund future capital requirements through equity offerings, debt financings, and collaborations, with no committed external sources of funds currently available[165]. - The company reported a net cash increase of $287.1 million for the three months ended March 31, 2024, primarily from financing activities[171]. - The company has total contractual obligations of $91.0 million, including $82.5 million under the Barings Credit Agreement[173]. - The company has a secured term loan facility with a principal amount of $82.5 million under a credit and security agreement with Barings Finance LLC as of March 31, 2025[187]. Market and Sales Performance - In-Market Sales of DEXTENZA were approximately 40,000 units in Q1 2025, a slight decrease of about 1,000 units from Q1 2024[114]. - The total gross-to-net provisions for DEXTENZA product sales were 49.4% for the three months ended March 31, 2025, compared to 36.1% in 2024[136]. - The company aims to commercialize DEXTENZA in the United States while expanding its operational and management systems[163]. Other Financial Considerations - Interest income was $3.8 million for the three months ended March 31, 2025, down from $3.9 million in 2024, a decrease of $0.1 million[149]. - Interest expense decreased to $3.0 million for the three months ended March 31, 2025, from $4.1 million in 2024, a reduction of $1.1 million[150]. - The Royalty Fee Derivative Liability was valued at $13.9 million as of March 31, 2025[188]. - The company is obligated to pay Incept a royalty equal to a low-single-digit percentage of net sales for Licensed Products in the Ophthalmic Field of Use[178]. - The company is also obligated to pay a mid-single-digit percentage royalty for Licensed Products in the Additional Field of Use[178]. - The company has no off-balance sheet arrangements as defined by the SEC regulations[179]. - An immediate 100 basis point change in interest rates would not have a material effect on the fair market value of the company's investment portfolio[185]. - The company evaluates its estimates and judgments related to revenue recognition and accrued research and development expenses on an ongoing basis[183]. - The company does not enter into financial instruments for trading or speculative purposes[186]. - Changes in the fair value of the Royalty Fee Derivative Liability have no impact on anticipated cash outflows related to this liability[188].