Anika Therapeutics, Inc. (Anika)operates as a global joint preservation company that creates and delivers meaningful advancements in early intervention orthopedic care.
The company develops minimally invasive products that restore active living for people around the world. The company is committed to leading in high opportunity spaces within orthopedics, including osteoarthritis (OA) Pain Management and Regenerative Solutions. The company’s proprietary technologies for modifying the HA molecule...
Anika Therapeutics, Inc. (Anika)operates as a global joint preservation company that creates and delivers meaningful advancements in early intervention orthopedic care.
The company develops minimally invasive products that restore active living for people around the world. The company is committed to leading in high opportunity spaces within orthopedics, including osteoarthritis (OA) Pain Management and Regenerative Solutions. The company’s proprietary technologies for modifying the HA molecule allow product properties to be tailored specifically to multiple uses, including enabling longer residence time to support OA Pain Management and creating a solid form of hyaluronic (HA) called Hyaff, which is a platform utilized in its regenerative solutions portfolio.
In early 2020, the company expanded its overall technology platform, product portfolio, and significantly expanded the company’s commercial infrastructure, especially in the United States, through its strategic acquisitions of Parcus Medical, LLC, a sports medicine and instrumentation solutions provider, and Arthrosurface Incorporated, a company specializing in bone preserving partial and total joint replacement solutions. These acquisitions augmented the company’s HA-based OA Pain Management and regenerative products with a broad suite of products and capabilities focused on early intervention joint preservation primarily in upper and lower extremities, such as shoulder, foot/ankle, knee and hand/wrist.
Products and Services
Anika provides a broad array of products and services, including:
Osteoarthritis (OA) Pain Management: Orthovisc, Monovisc, and Cingal.
Monovisc and Orthovisc are the company’s single- and multi-injection, HA viscosupplement products indicated for pain relief from OA conditions. Labeling in the United States limits their use to the knee exclusively, while labeling outside the U.S. is broader, providing expanded therapeutic options beyond the knee to include anatomies, such as the shoulder, hip, and ankle. The company’s OA Pain Management products are generally administered to patients in an office setting. In the United States, Monovisc and Orthovisc are marketed exclusively by J&J MedTech.
In December 2011, the company entered into a fifteen-year licensing agreement with J&J MedTech to exclusively market Monovisc in the United States through December 2026. In December 2003, the company entered into a ten-year licensing agreement to exclusively market Orthovisc in the United States. J&J MedTech extended this agreement for additional five-year terms in 2007, 2012, 2017, and most recently in August 2022. The agreement expires in December 2028 unless extended at the option of J&J MedTech.
Internationally, the company markets its OA Pain Management products directly through a worldwide network of commercial distributors, and the company’s international sales team has successfully expanded into new countries, driving double-digit growth in recent years.
Cingal is the company’s novel, next-generation, non-opioid, single-injection OA Pain Management product, consisting of its proprietary cross-linked HA material combined with a fast-acting steroid, designed to provide both short- and long-term pain relief. The company has been actively engaging with the FDA on next steps for U.S. regulatory approval.
In April 2023, the company held a Type-C meeting with the FDA, which led to an advice letter received from the FDA in April 2024. Additionally, in September 2024, the company acquired the Aristospan NDA, which allowed it to address a recent FDA requirement and will enables the company to source the reference drug for a bioequivalence study.
Regenerative Solutions: Integrity, Hyalofast, and Tactoset.
Integrity is an HA-based scaffold with bone and tendon fixation components and arthroscopic delivery instruments. It is designed to protect injured tendons and promote healing in rotator cuff repair and other tendon procedures. Integrity received FDA clearance for commercial use in the United States in August 2023 and the company initiated a limited market release in November 2023. Since its launch, Integrity has shown strong performance, with over 40% sequential growth in surgeries and significant adoption by new customers.
Hyalofast is a 100% HA resorbable scaffold used for single stage cartilage regeneration. While Tactoset and Integrity are commercialized principally in the United States, Hyalofast is available outside the United States in over 30 countries within Europe, South America, Asia, and certain other international markets. In the United States, Hyalofast is a pipeline product under a pivotal Investigational Device Exemption (IDE) clinical trial and is not available for commercial sale. The company has filed the first and second modules of its PMA with the FDA, and the product is on track for a U.S. launch by 2026.
Tactoset Injectable Bone Substitute is an HA-enhanced injectable bone repair therapy designed to treat insufficiency fractures and augment hardware fixation, such as suture anchors.
Non-Orthopedic Products: Hyvisc, Hyalobarrier, Anikavisc, Nuvisc
The company’s Non-Orthopedic product family consists of legacy HA-based products that are marketed principally for non-orthopedic applications. These products include Hyvisc, its high molecular weight injectable HA veterinary product for the treatment of joint dysfunction in horses due to non-infectious synovitis associated with equine OA; Hyalobarrier, an anti-adhesion barrier indicated for use after abdominal-pelvic surgeries; and ophthalmic products, including injectable, high molecular weight HA products, such as Anikavisc and Nuvisc, used as viscoelastic agents in ophthalmic surgical procedures such as cataract extraction and intraocular lens implantation. These Non-Orthopedic products are sold through commercial sales and marketing partners around the world.
Sales Channels
A majority of the company’s products are used by clinicians and surgeons in one of three environments: office-based procedures, hospital operating rooms, and ambulatory surgery centers (ASCs). Office-based procedures usually focus on injections, while ASCs are clinics outside of a normal hospital setting, often at least partially physician-owned. These medical care delivery environments typically require different commercial approaches and have distinct call points, necessitating diversity in the company’s sales strategy. For instance, the company’s OA Pain Management product family and certain products in its Non-Orthopedic category are almost entirely utilized in an office-based setting, while the company’s Regenerative Solutions and certain other products in its Non-Orthopedic category are almost exclusively used in hospital operating rooms or ASCs.
The company has maintained a mutually beneficial commercial partnership with J&J MedTech, which sells Monovisc and Orthovisc in the United States. The company has the U.S. commercial partnerships for other products in its Non-Orthopedic product families. Under these partnerships, the company sells its products directly to the company’s partners, who perform downstream sales and marketing activities to customers and end-users.
In the U.S., the company sells its Regenerative Solutions portfolio directly to clinicians, including hospitals and ASCs, through a hybrid approach involving its Anika sales team and a large network of independent third-party distributors.
Outside of the United States, the company markets and sells its products using a worldwide network of commercial distributors, providing a solid foundation for future revenue growth and territorial expansion. The company’s relationships with these partners are generally structured such that it sells the company’s products to them directly, while they, with global support from its team, perform in-country sales and marketing activities to drive local growth and adoption of the company’s products.
The company’s overall sales approach provides its business with a strong base to drive revenue growth as the company continues to grow and scale its commercial infrastructure. The company will continue to focus on expanding its commercial capabilities, including market access, innovative sales and delivery models, and improved logistics management.
Competition
For the company’s OA Pain Management products, its main competitors include Sanofi Genzyme, Zimmer Biomet, Inc., Bioventus Inc., Avanos Medical, Inc., Pacira BioSciences, Conmed Corporation, and Ferring Pharmaceuticals, among others. With respect to the company’s Regenerative Solutions products, its 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.
Trademarks
ANIKA, ANIKA THERAPEUTICS, ANIKAVISC, CINGAL, HYAFF, HYALOFAST, HYVISC, INTEGRITY, MONOVISC, ORTHOVISC, and TACTOSET are the company’s trademarks.
Research and Development
For 2024, the company’s research and development expenses were $25.6 million.
Seasonality
The company’s OA Pain Management and Non-Orthopedic product families are generally less seasonal in nature due to the nature of its product mix and sales channels and order strategies of the company’s customers. With the company’s Regenerative Solutions product portfolio, procedure volumes are normally higher in the fourth quarter due to several factors including the satisfaction by patients of insurance deductible limits and the time of year patients prefer to have elective procedures (year ended December 2024).
Governmental Regulation
The clinical development, manufacturing, and marketing of the company’s products are subject to governmental regulation in the United States, the European Union, and other territories worldwide, including under the Federal Food, Drug, and Cosmetic Act (FDCA) in the United States.
Some of the company’s products require premarket notification and clearance under section 510(k) of the FDCA.
The delivery of the company’s products is regulated by the U.S. Department of Health and Human Services and other state and non-U.S. government agencies responsible for healthcare reimbursement and regulation.
The company is subject to various U.S. federal and state laws pertaining to healthcare fraud and abuse, including anti-kickback, false claims, self-referrals, and other healthcare fraud. Additionally, the company is subject to U.S. federal and state transparency laws, such as the U.S. Physician Payments Sunshine Act, which requires it to annually disclose certain payments and other transfers of value made to U.S.-licensed healthcare practitioners (e.g., physicians, nurse practitioners, advanced practice registered nurses) and teaching hospitals.
The company is also subject to various laws and regulations concerning data privacy in the United States, Europe, and elsewhere, including the General Data Protection Regulation (GDPR), in the European Union and the United Kingdom.
History
Anika Therapeutics, Inc. was founded in 1983. The company was incorporated in 1992.
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