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Anika Therapeutics (ANIK) investor relations material
Anika Therapeutics Q2 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Executive summary
Regenerative Solutions revenue grew 41% year-over-year, led by Integrity Implant System, which exceeded 2024 performance and is on pace to more than double in 2025.
Q2 2025 revenue was $28.2M, down 8% year-over-year, mainly due to OEM channel declines and manufacturing issues.
Hyalofast Phase III trial missed co-primary endpoints but achieved significance on key secondary endpoints; FDA submission remains on track, with commercial launch now expected in 2027.
Strategic focus shifted to OA Pain Management and Regenerative Solutions, with divestitures of Arthrosurface and Parcus Medical completed.
Production yield issues resolved by June, with full production resumed and no impact on patient supply.
Financial highlights
Gross margin for Q2 2025 was 51%, down from 67% year-over-year, impacted by a $3M one-time charge for lower yields.
Adjusted EBITDA was negative $0.2M, a significant decline year-over-year, mainly due to one-time scrap costs and lower high-margin revenue.
Operating expenses declined 17% year-over-year, with SG&A down 22% and R&D down 6%.
Cash and cash equivalents at June 30, 2025, totaled $53.2M, with no outstanding debt.
Adjusted diluted loss per share for Q2 2025 was ($0.13); loss from continuing operations was ($4.6M).
Outlook and guidance
2025 commercial channel revenue expected at $47M–$49.5M (12%–18% growth); OEM channel at $62M–$65M (16%–20% decline).
Adjusted EBITDA guidance for 2025 remains at -3% to +3%.
Commercial channel growth outlook revised to 10%–20% for 2026 and 2027 due to Hyalofast launch delay; $3M Hyalofast revenue expected in 2027.
Focus remains on expanding OA Pain Management and Regenerative Solutions portfolios, including U.S. launches pending regulatory approval.
Cingal program advanced toward NDA filing, with bioequivalence study initiation expected by year-end.
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