Anika Therapeutics, Inc.

Anika Therapeutics, Inc. is a global leader in the OA Pain Management and regenerative solutions space, focusing on early intervention orthopedics. The Company leverages proprietary hyaluronic acid (HA) technology to develop highly differentiated products. In October 2024, the Company announced a strategic shift to concentrate on its OA Pain Management and Regenerative Solutions portfolios, which involved the sale of Arthrosurface Incorporated on October 31, 2024 and the sale of Parcus Medical, LLC on March 7, 2025.

For OA Pain Management products, main competitors include Sanofi Genzyme, Zimmer Biomet, Inc., Bioventus Inc., Avanos Medical, Inc., Pacira BioSciences, Conmed Corporation, and Ferring Pharmaceuticals. For Regenerative Solutions products, key competitors are Arthrex, Inc, Smith & Nephew PLC, Stryker Corporation, and Zimmer Biomet, Inc., as well as smaller organizations like Atreon Orthopedics and Bone Support AB. Monovisc and Orthovisc have been market leaders, based on combined overall revenue in the viscosupplement market, since 2018.

The Company generates revenue through two channels: the OEM Channel, where it sells to partners like J&J MedTech who perform downstream sales and marketing, and the Commercial Channel, where it has full responsibility for sales, marketing, and pricing. Revenue is derived from product sales to commercial partnerships, hospitals and ambulatory surgery centers, and distributors. The Company's largest customer, J&J MedTech, accounted for 50% of total revenue for the year ended December 31, 2025.

The OA Pain Management product family consists of Orthovisc, Monovisc, and Cingal. Monovisc and Orthovisc are HA viscosupplement products for pain relief from OA conditions, with labeling in the United States limited to the knee exclusively. Cingal is a next-generation, non-opioid, single-injection OA Pain Management product combining cross-linked HA with a fast-acting steroid, designed to provide both short- and long-term pain relief; it is currently sold outside the United States in 53 countries and is not approved for commercial use in the United States. The Regenerative Solutions product family includes the Integrity Implant System, an HA-based scaffold for rotator cuff and other tendon repairs that received FDA clearance in August 2023; Hyalofast, a 100% HA resorbable scaffold for cartilage repair currently available outside the United States in over 30 countries; and Tactoset Injectable Bone Substitute, an HA-enhanced injectable bone repair therapy. Non-Orthopedic products include Hyvisc (veterinary), Hyalobarrier (anti-adhesion), and ophthalmic products Anikavisc and Nuvisc.

In October 2024, the Company completed the sale of Arthrosurface Incorporated to Phoenix Brio, Incorporated. As consideration, the Company received a ten-year non-interest bearing promissory note in the principal amount of $7.0 million ¹ and is eligible to receive Revenue Payments and a Buy-Out Payment of the greater of $14.0 million ² or ten times the Revenue Payments. On March 7, 2025, the Company completed the sale of Parcus Medical, LLC to Medacta Americas Manufacturing, Inc. for a cash payment of $4.5 million ³. In May 2024, the Company's Board of Directors approved a share repurchase program for an aggregate purchase price of $40.0 million ⁴. As of December 31, 2025, the Company had repurchased 1,308,545 ⁵ shares at an average cost of $15.63 ⁶ per share, representing 51% ⁷ of the then estimated total number of shares expected to be repurchased under the program. On October 16, 2025, J&J MedTech extended the agreement to exclusively market Monovisc in the United States through December 2031 ⁸.

For the year ended December 31, 2025, total revenue was $112,819 ⁹ thousand, a decrease of $7,088 ¹⁰ thousand, or 6% ¹¹, compared to $119,907 ¹² thousand in the prior year. Gross profit was $63,807 ¹³ thousand, or gross margin of 57% ¹⁴, compared to $75,998 ¹⁵ thousand, or gross margin of 63% ¹⁶, in 2024. Loss from continuing operations was $9,979 ¹⁷ thousand, compared to a loss of $8,828 ¹⁸ thousand in 2024. Net loss was $10,880 ¹⁹ thousand, compared to a net loss of $56,385 ²⁰ thousand in 2024. Cash and cash equivalents aggregated $57,481 ²¹ thousand at December 31, 2025.

The Company submitted its premarket approval (PMA) application with the FDA for Hyalofast on October 31, 2025. The Company received a letter from the FDA in January 2026 identifying a number of deficiencies, and the Company is preparing its response. The Company is targeting a U.S. launch for Hyalofast by 2027, pending approval from the FDA. The Company is also actively engaging with the FDA on next steps for regulatory approval of Cingal in the U.S., and has initiated preclinical and bioequivalence studies.

The Company will continue to invest in its Regenerative Solutions R&D pipeline as it prepares for the potential U.S. approval and launch of both Hyalofast and Cingal, each representing an incremental U.S. addressable market of at least $1 billion ²². The Integrity Implant System competes in a U.S. tendon augmentation market estimated to be more than $220 million ²³ annually. The Company will also build on the international commercial momentum of its entire OA Pain Management portfolio, led by Monovisc and Cingal.

For the year ended December 31, 2025, research and development expenses were $25,770 ²⁴ thousand, compared to $25,544 ²⁵ thousand in 2024. The increase in 2025 was primarily due to costs associated with increased spending on Cingal U.S. regulatory submission activities and the Integrity clinical study. The Company anticipates continuing to commit resources to research and development activities, primarily for new product development, regulatory compliance, scale-up manufacturing activities, and preclinical and clinical studies.

To support higher expected output of OA Pain Management and Regenerative Solutions products, the Company is investing in its Bedford manufacturing facility. The Company relies on a small number of suppliers for certain key raw materials and other components required for manufacturing and delivery of its products.

For 2025, 2024, and 2023, research and development expenses were $25.8 million ²⁶, $25.5 million ²⁷, and $21.8 million ²⁸, respectively. Cash used in investing activities was $0.4 million ²⁹, $8.3 million ³⁰, and $5.4 million ³¹ for 2025, 2024, and 2023, respectively. The Company had a share repurchase program for an aggregate purchase price of $40.0 million ³². As of December 31, 2025, the Company had repurchased 1,308,545 ³³ shares at a cost of $20.5 million ³⁴, representing 51% ³⁵ of the 2024 Share Repurchase Program. The Company has never declared or paid any cash dividends on its common stock.

The Company faces a longer than expected pathway to commercialization of its Cingal product in the United States. In July 2025, the Company announced topline results from its U.S. pivotal FastTRACK Phase III trial of Hyalofast, which failed to achieve the pre-specified co-primary endpoints for pain and function. The Company received a deficiency letter from the FDA in January 2026 regarding the Hyalofast PMA. The Company is also subject to risks from substantial competition, consolidation in the healthcare industry, and dependence on a small number of customers, with J&J MedTech accounting for 50% ³⁶ of revenue in 2025.

The Company's financial performance depends on sales growth and increasing demand for its product portfolios, and it may not be able to successfully manage the expansion of its operations. A significant portion of OA Pain Management revenues are derived from a small number of customers; in 2025, J&J MedTech accounted for 50% ³⁷ of revenue. The Company faces a longer than expected pathway to commercialization of Cingal in the United States and may face unforeseen difficulties in achieving regulatory approval for Cingal and Hyalofast. The Company's license agreements with J&J MedTech provide substantial control of Monovisc and Orthovisc in the United States to J&J MedTech, and J&J MedTech's actions could have a material impact on the business. The Company relies on a small number of suppliers for certain key raw materials, and disruption could materially adversely affect its business.

Management's message emphasizes a strategic shift to concentrate on OA Pain Management and Regenerative Solutions, driven by HA-based products. Key strategic priorities include commercial execution and adoption of the Integrity Implant System, continued investment in the Regenerative Solutions R&D pipeline for potential U.S. approval and launch of Hyalofast and Cingal, and building on international commercial momentum. The Company submitted its PMA for Hyalofast on October 31, 2025, and is targeting a U.S. launch by 2027, pending FDA approval. The Company is also actively engaging with the FDA on next steps for Cingal's U.S. regulatory approval.