Anika Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue for the third quarter was $30.6 million, a 10% increase year over year from $27.8 million.
• Commercial Channel revenue reached $14.0 million, up 17% year over year.
• OEM Channel revenue reached $16.6 million, up 5% year over year.
• Gross margin improved to 62% in the third quarter, compared to 56% in the prior-year period.
• Operating expenses were $19.5 million, up 4% year over year.
• GAAP loss from continuing operations was $0.3 million ($0.02 per diluted share), compared to a loss of $3.2 million ($0.22 per diluted share) in the prior year.
• Adjusted net income from continuing operations was $3.9 million ($0.29 per diluted share), compared to $0.7 million ($0.04 per diluted share) in the prior year.
• Adjusted EBITDA was $5.1 million, compared to $0.9 million in the prior year.
• Cash and cash equivalents stood at $45.0 million as of September 30, 2026.
• For the nine months ended September 30, 2026, total revenue was $92.8 million, up 13% year over year.

Guidance and Future Outlook:

• Raised the lower end of full-year 2026 total company revenue guidance to 6% to 10% (previously 5% to 10%).
• Raised full-year 2026 adjusted EBITDA margin guidance to 15% to 17% (previously 13% to 17%).
• Updated 2026 Commercial Channel revenue growth guidance to 9% to 13% (previously 12% to 18%) to reflect a slower elective surgery market.
• Updated 2026 OEM Channel revenue growth guidance to 5% to 9% (previously 0% to 5%).
• Reaffirmed full-year 2027 total company revenue growth guidance of flat to 5%.
• Reaffirmed 2027 Commercial Channel revenue growth guidance of 5% to 15%.
• Reaffirmed 2027 OEM Channel revenue growth guidance of flat to modestly lower.

Business Segments and Product Lines:

• Integrity revenue grew more than 30% year over year in the third quarter and 37% year to date, contributing $7.5 million in revenue over the trailing 12 months.
• International viscosupplement revenue increased 19% year over year in the third quarter.
• Total Regenerative Solutions revenue increased 12% year over year.
• Hyvisc growth contributed to OEM Channel performance.
• Reintroduced Hyalomatrix, a Hyaff wound product, in the U.S. through a new OEM distributor with first commercial units shipped in the third quarter.
• Launched second-generation Integrity instrumentation in September.
• Expanded use of Integrity into foot & ankle and knee applications following the introduction of larger implant sizes in late 2025 and early 2026.

Market and Competitive Landscape:

• Commercial Channel growth was supported by international viscosupplement growth and Integrity adoption.
• OEM Channel growth was supported by Hyvisc growth and J&J DePuy Synthes sales.
• The company noted more market-wide seasonality than usual in the summer months affecting the elective surgery market.

Risks and Challenges:

• The U.S. FDA notified Anika that its Hyalofast pre-market approval (PMA) application is not approvable, primarily based on clinical data included in the submission.
• The company is assessing available regulatory pathways and next steps for Hyalofast, including discussions with the FDA regarding additional evidence required.
• The Cingal new drug application (NDA) is expected to be submitted before year-end 2027 following the completion of the bioequivalence study enrollment in September.
• Demand has exceeded forecasts, requiring increased production and safety stock building.

Management Commentary and Tone:

• CEO Steve Griffin stated the company executed against three priorities: accelerating revenue growth, strengthening operational execution, and advancing the pipeline.
• Management expressed confidence in the full-year 2026 outlook and 2027 revenue expectations based on progress made.
• The company highlighted double-digit year-to-date revenue growth across both channels.
• Management noted that gross margin improvements were driven by manufacturing productivity, partially offset by product mix from the reintroduction of Hyalomatrix.

Other Key Points:

• Secured a new 10-year partnership with Boehringer Ingelheim for the distribution of Hyvisc with enhanced economics, including higher transfer pricing, royalties, and contractual purchases.
• The Hyvisc partnership agreement includes $8 million in expected payments: a $4 million upfront payment in Q1 2027 and $4 million tied to commercial volumes.
• Manufacturing capacity was increased to support future growth, with unit volumes on the cross-link line now more than 50% above 2022 levels.
• FDA approval was received for new aseptic manufacturing processes and validation of a second cross-link filler.
• The company repurchased $9.5 million of common stock during the nine months ended September 30, 2026.
• Stock-based compensation expense was $12.7 million for the nine months ended September 30, 2026, compared to $7.6 million in the prior year period.