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:
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Hyalofast Clinical Trial Update
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:
- Decline in Microfracture Usage: Microfracture, initially considered the standard of care, has seen a significant decline in broad use by surgeons during the 10-year trial enrollment period. It is no longer widely regarded as the standard of care for cartilage lesions in many countries, including the U.S.
- Subject Dropout and Missed Visits: The study was likely affected by a higher subject dropout rate in the microfracture arm and missed visits during the COVID-19 pandemic, resulting in missing data and a reduced evaluable sample size.
- Statistical Imputation: The company statistically imputed missing data according to FDA guidelines, which did not treat withdrawals from the microfracture arm as treatment failures.
Despite missing the co-primary endpoints, the company emphasized the positive aspects of the study:
- Statistical Significance on Secondary Endpoints: The study achieved statistical significance on several key secondary endpoints and other measures, including KOOS Sports and Recreation Function, KOOS Quality of Life, and Total KOOS. These measures have served as the basis for FDA approval of other cartilage repair products in the U.S.
- Extensive International Data: Hyalofast has been successfully used to treat over 35,000 patients in more than 35 countries since its launch outside the U.S. in 2009. A substantial amount of clinical data from independent international studies supports its efficacy, including a paper published last year with positive 15-year outcomes.
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.
Cingal Program Update
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.
Integrity Implant System Performance
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.
Second Quarter 2025 Financial Results
- Total Revenue: \$28.2 million, an 8% decrease compared to the same period in 2024.
- Commercial Channel Revenue: Flat year-over-year at \$11.9 million, with Regenerative Solutions growing 41%.
- OEM Channel Revenue: \$16.3 million, a 13% decrease, in line with expectations.
- Gross Margin: 51%, down from the previous year, primarily due to a one-time \$3 million charge related to lower production yields.
- Operating Expenses: \$18.5 million, a 17% decrease.
- Adjusted EBITDA: Negative \$200,000.
- Cash and Liquidity: \$53 million in cash and no debt.
Production challenges experienced earlier in the quarter have been resolved, and output has been restored to historic levels.
Full Year 2025 Financial Outlook (Maintained)
- Commercial Channel Revenue: \$47 million to \$49.5 million (12% to 18% growth).
- OEM Channel Revenue: \$62 million to \$65 million (16% to 20% decline).
- Adjusted EBITDA: Negative 3% to positive 3%.
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.
Key Takeaways
- The Hyalofast clinical trial results were mixed, with the study missing its co-primary endpoints but achieving statistical significance on several secondary endpoints. The company believes the totality of the data supports a viable path to FDA approval.
- The Integrity Implant System continues to perform exceptionally well, driving growth in the Regenerative Solutions segment.
- The company is making progress on the Cingal NDA submission.
- Financial results were in line with expectations, despite some challenges with manufacturing yields.
- The company is maintaining its full-year 2025 financial guidance.
The company remains confident in its key value drivers and its ability to deliver innovative solutions to improve patient outcomes.
