Ocular Therapeutix: Q3 Earnings Snapshot
Thursday, Nov 14, 2024 7:44 am ET
4min read Ocular Therapeutix, Inc. (NASDAQ: OCUL), a biopharmaceutical company focused on improving vision through innovative therapies, recently reported its third-quarter 2024 earnings. The company's financial results and recent business highlights provide valuable insights into its progress and potential for investors.
Ocular Therapeutix's Q3 2024 earnings report highlighted several key achievements and upcoming milestones. The company's exceptional pace of recruitment in the SOL-1 superiority trial for AXPAXLI™ (axitinib intravitreal implant) in wet age-related macular degeneration (wet AMD) is expected to result in full randomization by the end of 2024. Topline data from the SOL-1 trial are now anticipated during the fourth quarter of 2025. The study is being conducted under a Special Protocol Agreement (SPA) with the U.S. Food and Drug Administration (FDA).
Direct enrollment is now open for the SOL-R AXPAXLI repeat dosing registrational trial (Phase 3, wet AMD). This change allows physicians to enroll eligible subjects directly into SOL-R as SOL-1 nears the completion of randomization. The SOL-R trial was designed to complement SOL-1 with repeat and flexible dosing while providing commercially meaningful data. In a written Type C response, the FDA confirmed in August 2024 that the SOL-R trial should be appropriate for use as Ocular's second adequate and well-controlled study to support a potential New Drug Application (NDA) and product label for wet AMD.
Ocular Therapeutix's financial results for the third quarter ended September 30, 2024, showed a total cash and cash equivalents balance of $427.2 million. Based on current plans and related estimates of anticipated cash inflows from DEXTENZA®, the company believes that its current cash balance is sufficient to support its planned expenses, obligations, and capital expenditure requirements into 2028. Total net revenue for the quarter was $15.4 million, a 2.3% increase over total net revenue of $15.1 million in the comparable period in 2023. This increase was driven by increased gross revenues from DEXTENZA sales, offset by higher gross-to-net provisions in the 2024 period compared to the prior comparable period. The Company expects full-year 2024 total net revenues for DEXTENZA to be between $62.0 million and $67.0 million, compared to $57.9 million reported for 2023.
Ocular Therapeutix's Q3 2024 earnings report demonstrates the company's strong financial position and progress in its AXPAXLI clinical trials. The accelerated timelines for the SOL-1 and SOL-R trials, along with the FDA's confirmation of the SOL-R trial's adequacy and well-controlled status, bode well for the company's regulatory timeline for AXPAXLI in wet AMD. As Ocular Therapeutix continues to execute its strategic plans, investors should monitor the company's progress and consider the potential milestones ahead in 2025.
Ocular Therapeutix's Q3 2024 earnings report highlighted several key achievements and upcoming milestones. The company's exceptional pace of recruitment in the SOL-1 superiority trial for AXPAXLI™ (axitinib intravitreal implant) in wet age-related macular degeneration (wet AMD) is expected to result in full randomization by the end of 2024. Topline data from the SOL-1 trial are now anticipated during the fourth quarter of 2025. The study is being conducted under a Special Protocol Agreement (SPA) with the U.S. Food and Drug Administration (FDA).
Direct enrollment is now open for the SOL-R AXPAXLI repeat dosing registrational trial (Phase 3, wet AMD). This change allows physicians to enroll eligible subjects directly into SOL-R as SOL-1 nears the completion of randomization. The SOL-R trial was designed to complement SOL-1 with repeat and flexible dosing while providing commercially meaningful data. In a written Type C response, the FDA confirmed in August 2024 that the SOL-R trial should be appropriate for use as Ocular's second adequate and well-controlled study to support a potential New Drug Application (NDA) and product label for wet AMD.
Ocular Therapeutix's financial results for the third quarter ended September 30, 2024, showed a total cash and cash equivalents balance of $427.2 million. Based on current plans and related estimates of anticipated cash inflows from DEXTENZA®, the company believes that its current cash balance is sufficient to support its planned expenses, obligations, and capital expenditure requirements into 2028. Total net revenue for the quarter was $15.4 million, a 2.3% increase over total net revenue of $15.1 million in the comparable period in 2023. This increase was driven by increased gross revenues from DEXTENZA sales, offset by higher gross-to-net provisions in the 2024 period compared to the prior comparable period. The Company expects full-year 2024 total net revenues for DEXTENZA to be between $62.0 million and $67.0 million, compared to $57.9 million reported for 2023.
Ocular Therapeutix's Q3 2024 earnings report demonstrates the company's strong financial position and progress in its AXPAXLI clinical trials. The accelerated timelines for the SOL-1 and SOL-R trials, along with the FDA's confirmation of the SOL-R trial's adequacy and well-controlled status, bode well for the company's regulatory timeline for AXPAXLI in wet AMD. As Ocular Therapeutix continues to execute its strategic plans, investors should monitor the company's progress and consider the potential milestones ahead in 2025.
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