Anika Therapeutics (ANIK) Sidoti Micro-Cap Virtual Conference summary

Business overview and strategic focus

• Focused on early intervention orthopedics, joint preservation, regenerative therapy, and OA pain management, targeting large addressable markets with significant unmet needs.

• OA pain management is the largest business segment, with Monovisc and Orthovisc holding the number one US market position through a partnership with Johnson & Johnson.

• Strong international growth in OA pain products, with 17% growth in H1 and 19% in Q2, driven by Monovisc, Orthovisc, and Cingal.

• Proprietary hyaluronic acid (HA) technology underpins both pain management and regenerative product lines.

• Cost reductions and capital allocation strategies are enhancing shareholder value, with visible impact on financials.

Product innovation and pipeline

• Integrity Implant System fully launched in July 2024 after a successful limited market release, showing strong market pull and 40% procedural growth from Q1 to Q2.

• Cingal, a next-generation OA pain product, is sold in over 40 countries and progressing toward FDA approval for US launch.

• Hyalofast, a single-stage cartilage repair product, is sold in 35+ countries and expected to launch in the US by 2026, targeting a billion-dollar market.

• New product development pipeline leverages the Integrity and Hyalofast platforms, with plans for expanded indications and geographies.

• Manufacturing capacity is sufficient to support anticipated growth, with ongoing investments in the Bedford facility.

Market dynamics and growth outlook

• US OA pain market expected to see low single-digit growth, while international OA pain business is growing at double digits.

• Regenerative business, led by Integrity and soon Hyalofast, is the primary growth engine, with 40% sequential growth in procedures and significant market expansion opportunities.

• Integrity is being adopted across multiple orthopedic disciplines, expanding beyond the initial rotator cuff indication.

• Cingal’s US launch is expected to be partnered, leveraging prior successful commercialization models.

• Hyalofast’s US launch is on track, with regulatory milestones set for 2024 and 2025, and strong clinical data supporting market entry.