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 other regenerative products are part of a growing U.S. portfolio, with additional pipeline products in development.

Strategic focus and capital allocation

• Refocus strategy centers on proprietary hyaluronic acid technology for OA pain and regenerative markets.

• Divestiture of non-core assets, including Parcus Medical and Arthrosurface, to streamline operations.

• Renewed capital allocation prioritizes high-growth, differentiated HA products.

• Share repurchase program underway, with $5.3M repurchased out of a $40M authorization.

• OEM channel remains highly profitable, while commercial channel drives growth.

Regulatory and market expansion updates

• Cingal faces FDA regulatory hurdles, including new requirements for drug-device classification and bioequivalence studies.

• Type C meeting with FDA will clarify the final regulatory path and timeline for Cingal's U.S. entry.

• Hyalofast has Breakthrough Device Designation, with PMA submission completion expected in 2025 and U.S. launch by 2026.

• Integrity and future products are expanding into broader tendon repair markets.

• OA pain and regenerative portfolios are expected to drive significant U.S. and global growth.