Anika Therapeutics (ANIK) Piper Sandler 36th Annual Healthcare Conference summary

Business overview and product portfolio

• Holds leading U.S. market share in OA pain management with Orthovisc and Monovisc, generating strong cash flow.

• Cingal, a next-generation OA pain product, is sold internationally and is progressing toward U.S. launch.

• Integrity, a regenerative rotator cuff repair system, is experiencing 40% sequential growth and expanding into new applications.

• Hyalofast, a single-stage cartilage repair product, is set for U.S. launch by 2026, targeting a $1B+ market.

• Tactoset and additional regenerative products are part of a growing U.S. portfolio.

Strategic focus and capital allocation

• Recently adopted a refocus strategy, emphasizing highly differentiated hyaluronic acid (HA) products.

• Divesting non-core assets, including Parcus Medical and Arthrosurface, to concentrate on core HA business.

• Commercial channel is driving growth, while the OEM channel remains the main profitability driver.

• Ongoing share repurchase program, with $5.3M repurchased out of a $40M authorization.

• Renewed capital allocation aims to support new product launches and expand the regenerative platform.

Regulatory and clinical progress

• Cingal faces FDA regulatory hurdles due to reclassification as a drug-device combination, requiring new animal and bioequivalence studies.

• Type C meeting with FDA will clarify the final regulatory path and study requirements for Cingal.

• Hyalofast has Breakthrough Device Designation, with a definitive clinical trial readout expected mid-next year and PMA submission completion in 2025.

• Over 40 clinical publications and 15-year data support Hyalofast's efficacy and market potential.