
Anika Therapeutics, Inc. recently held an earnings call to discuss their second quarter 2025 financial results and provide updates on key programs. Here’s a breakdown of the information shared during the call:
A significant portion of the discussion focused on the Phase III clinical trial for Hyalofast, a treatment for articular cartilage defects. This randomized controlled trial compared Hyalofast in combination with autologous bone marrow aspirate concentrate (BMAC) to microfracture, a surgical technique, as the control arm.
While Hyalofast demonstrated consistent improvements in treated patients across various pain and function measures compared to microfracture, the study did not achieve statistical significance on its pre-specified co-primary endpoints under the original statistical framework. These co-primary endpoints were the percent change from baseline to two years in KOOS Pain and IKDC Function.
Several factors may have contributed to this outcome:
Despite missing the co-primary endpoints, the company emphasized the positive aspects of the study:
The company plans to submit the third and final PMA module in the second half of the year, including post-hoc analyses and additional endpoints that achieved statistical significance. The commercial timeline has been extended to 2027 to allow for a thorough FDA review.
Progress is being made on Cingal, with the company advancing the final steps toward NDA filing. They remain on track to initiate the bioequivalence study by year-end, which, along with toxicity studies, addresses the final requirements before submission. An update on the Cingal program timing will be provided after the bioequivalence study begins.
The Integrity Implant System is performing exceptionally well, already exceeding its full-year 2024 performance and on track to more than double in 2025. This growth is attributed to positive early clinical data, strong market momentum, and increasing adoption by surgeons. Surgeons are not only using Integrity more frequently but also expanding its application to a wider range of tendon repair procedures, including those in the hip, knee, and ankle.
Two new Integrity shapes and sizes received 510(k) clearance during the quarter and are planned for a limited release by year-end. These new SKUs are designed to support repairs in various tendons, further strengthening the company’s ability to penetrate the market.
Production challenges experienced earlier in the quarter have been resolved, and output has been restored to historic levels.
Long-term revenue guidance for the commercial channel has been revised to reflect a potential extension of the FDA review process for Hyalofast. Commercial channel growth is now projected at 10% to 20% in both 2026 and 2027.
The company remains confident in its key value drivers and its ability to deliver innovative solutions to improve patient outcomes.