Anika ups guidance despite HYALOFAST setback and U.S. OA pricing pressure

Anika raises 2026 revenue and EBITDA margin guidance after strong Q3 despite HYALOFAST setback and U.S. OA pricing pressure

• Q3 revenue rose 10% to $30.6M, driven by 17% commercial and 5% OEM growth.
• Q3 non-GAAP EPS was $0.29, up 625% year over year but missing analyst estimates, while revenue beat expectations.
• Gross margin improved to 62% from 56% YoY, though down from 65% in Q2 on mix.
• Adjusted EBITDA jumped to $5.1M from $0.9M, with adjusted EPS at $0.29 per share.
• Management raised 2026 revenue growth guidance to 6–10% and EBITDA margin to 15–17%.
• Commercial guidance cut to 9–13% growth on elective surgery softness; OEM raised to 5–9%.
• FDA deemed HYALOFAST PMA not approvable, delaying any U.S. revenue and adding regulatory uncertainty.
• CINGAL NDA now targeted before year-end 2027, with bioequivalence report expected in Q1 2027.
• New 10-year Boehringer Ingelheim agreement improves economics and secures $8M in upfront and milestones.
• Main concern: U.S. HYALOFAST non-approvable decision and ongoing U.S. OA pricing pressure into 2027.
• Strong quarter, driven by commercial growth, OEM outperformance and significant gross margin expansion.

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