Anika Therapeutics, Inc. (ANIK) Q3 2025 Earnings Summary

Executive Summary

• Q3 2025 revenue was $27.8M, down 6% YoY, with Commercial Channel up 22% offsetting OEM’s 20% decline; gross margin improved sequentially to 56% but fell 10 pts YoY on lower J&J OA pricing .
• Adjusted diluted EPS was $0.04 vs Wall Street consensus of $0.02 (beat); revenue was essentially in line at $27.8M vs $27.8M consensus; management reaffirmed FY25 channel revenue and adjusted EBITDA % guidance . Estimates values retrieved from S&P Global.*
• Integrity’s momentum continued (sixth consecutive quarter of growth) with roughly 500 procedures and nearly 300 surgeon users; J&J MedTech extended Monovisc license and supply agreement through December 2031, supporting OEM visibility .
• Regulatory catalysts advanced: final Hyalofast PMA module filed with statistically significant secondary endpoints; Cingal U.S. NDA path progressed (toxicity study completed, bioequivalence study screening underway) .

What Went Well and What Went Wrong

What Went Well

• Commercial Channel strength: +22% YoY, driven by Integrity (+25% Regenerative Solutions) and double-digit international OA Pain growth; “Integrity…keeps us on track to more than double procedures and revenue in 2025 compared to 2024” — Cheryl Blanchard .
• Operating discipline: SG&A -12% YoY; total OpEx -3%; adjusted EBITDA positive at $0.9M; operating cash flow $6.9M .
• Strategic/regulatory progress: Hyalofast PMA final module filed; FastTRACK data showed statistically significant improvements in KOOS Sports, QoL and Total KOOS; Cingal surpassed 1M injections OUS since 2016 and progressed toward NDA .

What Went Wrong

• OEM Channel headwinds: revenue -20% YoY; pricing pressure in U.S. OA (Monovisc price -17% YTD despite unit +11%); Orthovisc also pressured; gross margin -10 pts YoY largely from lower J&J pricing .
• Production yield issues’ “hangover”: sequential margin recovery, but lingering backlog for some OUS distributors; normalization expected by year-end .
• Hyalofast primary endpoints: FastTRACK did not meet pre-specified co-primary endpoints under original framework, necessitating post-hoc analyses (observed data, responder analysis) to demonstrate significance in KOOS Pain and support PMA .

Financial Results

Headline Metrics (continuing operations)

Segment Revenue

Q3 2025 vs Estimates

Values retrieved from S&P Global.*

KPIs and Operating Drivers

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “Commercial Channel revenue increased 22%…Regenerative Solutions revenue increasing 25%…J&J MedTech has exercised its option to continue our license and supply agreement for Monovisc for another 5-year term through December 2031.” — Cheryl Blanchard .
• “Integrity procedures…outpace the U.S. soft tissue augmentation market…on pace to more than double procedures and revenue in 2025.” — Press release .
• “Third quarter gross margin was 56%…year-over-year decline primarily driven by a $3.2M reduction in Monovisc and Orthovisc sales to J&J, largely due to lower pricing.” — Steve Griffin .
• “We submitted the third and final module of our PMA to the FDA…statistically significant improvements in KOOS sports, QoL, and Total KOOS…observed data analysis achieved significance for KOOS pain.” — Cheryl Blanchard .
• “We are commencing a second $15 million share repurchase…expected to complete by June of 2026.” — Steve Griffin .

Q&A Highlights

• Integrity growth strategy: Balanced focus on expanding surgeon base and deepening utilization with training/education; larger SKUs to drive tendon applications (hip/knee/foot/ankle) .
• Cingal timeline: BE study to start by year-end; toxicity study in Q1; fuller timeline next call; all on track .
• Capital allocation: Priority order — internal investment (Integrity/Hyalofast), capacity CapEx in Bedford, then repurchases; M&A not near-term .
• Production issues: Residual “hangover” from yield disruptions, capacity catch-up underway; minimal U.S. impact; healthy by year-end .
• Gross margin outlook: Normalized 55–60% depending on J&J pricing volatility; Q4 expected modestly higher than Q3 .

Estimates Context

• Q3 results vs consensus: Revenue $27.8M* actual $27.817M (in line); EPS $0.02* vs adjusted diluted $0.04 (beat). Values retrieved from S&P Global.*
• Forward quarter (Q4 2025) consensus: Revenue $28.875M*; EPS $0.02*. Values retrieved from S&P Global.*
• Note: Consensus “EBITDA” reflects SPGI standard definition (Q3 estimate ~$0.685M* vs actual -$1.83M*), while company reports Adjusted EBITDA of $0.865M; differences are due to non-GAAP adjustments (stock-based comp, non-recurring fees) and SPGI standardization . Values retrieved from S&P Global.*

Key Takeaways for Investors

• Commercial Channel momentum (Integrity, Hyalofast OUS, Int’l OA Pain) is offsetting OEM pricing pressure; mix shift and cost discipline are stabilizing profitability and cash flow .
• Q3 printed an EPS beat vs consensus and sequential margin recovery; near-term stock reaction likely hinges on OEM pricing stabilization signals and execution on Integrity SKUs .
• OEM visibility improved with J&J’s Monovisc extension through 2031; unit growth +11% YTD suggests price pressure may be partly offset by volume into 2026 .
• Hyalofast PMA filing and meaningful secondary endpoints create a regulatory catalyst; FDA’s view of post-hoc analyses and responder results will be critical to U.S. approval odds .
• Cingal NDA path advancing (toxicity done, BE screening started); timeline update next quarter is a key watch item; OUS traction (>1M injections) underscores product value .
• Operational normalization and capacity expansions aim to support demand and margin; CFO frames normalized GM at 55–60% subject to J&J pricing dynamics .
• Capital returns continue with new $15M 10b5-1 through June 2026, supported by $58M cash and no debt; preserves flexibility for pipeline and capacity investments .