About Anika Therapeutics

Anika Therapeutics, Inc. operates as a global joint preservation company that creates and delivers meaningful advancements in early intervention orthopedic care. Based on the company’s collaborations with clinicians to understand what they need most to treat their patients, 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, or OA pain management, regenerative solutions, sports medicine and Arthrosurface joint solutions. The company has global expertise developing, manufacturing and commercializing products based on the company’s hyaluronic acid, or HA, technology platform. 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 HA called Hyaff, which is the platform for some of the company’s 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 the company’s strategic acquisitions of Parcus Medical, LLC, or Parcus Medical, a sports medicine and instrumentation solutions provider, and Arthrosurface, Inc., or Arthrosurface, a company specializing in bone preserving partial and total joint replacement solutions. These acquisitions have ignited the transformation of the company by augmenting its 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. Strategy Beginning in 2020, the company launched its transformational strategy to diversify its revenue in the global joint preservation markets, expanding the company’s addressable global market from the over $1 billion global OA pain management market to the over $8 billion global joint preservation market (which includes faster growing regenerative medicine, sports medicine and extremities segments). Products OA Pain Management The company’s OA Pain Management product family consists of: Monovisc and Orthovisc, the company’s single- and multi-injection, HA-based viscosupplement product offerings indicated to provide pain relief from OA conditions solely for use in the knee. 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 DePuy Synthes Mitek Sports Medicine, part of the Johnson & Johnson Medical Companies, or Mitek. In December 2011, the company entered into a fifteen-year licensing agreement with Mitek 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. Mitek extended this agreement for additional five-year terms in 2007, 2012, 2017 and most recently in August 2022. The current agreement expires in December 2028 unless extended at the option of Mitek. The Monovisc and Orthovisc products have been the market leaders, based on combined overall revenue in the viscosupplement market, since 2018. Internationally, the company markets its OA Pain Management products directly through a worldwide network of commercial distributors. Cingal, the company’s novel, next-generation, single-injection OA Pain Management product consisting of the company’s proprietary cross-linked HA material combined with a fast-acting steroid, designed to provide both short- and long-term pain relief. Cingal is CE marked and for several years has been sold outside the United States directly in over 35 countries through the company’s network of distributors. In the United States, Cingal is a pipeline product not yet approved for commercial sale. Hyvisc, the company’s high molecular weight injectable HA veterinary product for the treatment of joint dysfunction in horses due to non-infectious synovitis associated with equine OA. Joint Preservation and Restoration The company’s Joint Preservation and Restoration product family, consists of: Regenerative Solutions: The company’s portfolio of orthopedic regenerative solutions leveraging its proprietary technologies based on HA and Hyaff, which is a solid form of HA. These products include Tactoset Injectable Bone Substitute, an HA-enhanced injectable bone repair therapy designed to treat insufficiency fractures and for augmenting hardware fixation, such as suture anchors, and Hyalofast, a biodegradable support for human bone marrow mesenchymal stem cells used for cartilage regeneration and as an adjunct for microfracture surgery. Tactoset is commercialized principally in the United States, whereas 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, or IDE, clinical trial and is not available for commercial sale. Sports Medicine: The company’s line of soft tissue repair solutions is used by surgeons to repair and reconstruct damaged ligaments and tendons resulting from sports injuries, trauma and disease. These more traditional sports medicine solutions include screws, sutures, suture anchors, grafts and other surgical systems that facilitate surgical procedures on the shoulder, knee, hip, upper and lower extremities, and other soft tissues. The company’s X-Twist Fixation System, launched in September of 2022 for limited use and fully launched in early 2023 for broad market use in the United States and certain international markets, is a platform of knotless and knotted suture anchors designed for soft tissue repairs in the shoulder and other extremities. Arthrosurface Joint Solutions: The company’s portfolio of more than 150 bone preserving joint solutions, including partial joint replacement, joint resurfacing, and minimally invasive and bone sparing implants, is designed to treat upper and lower extremity orthopedic conditions, as well as knee and hip conditions caused by arthritic disease, trauma and injury. These products span multiple joints, including OVOMotion with Inlay Glenoid for the shoulder, WristMotion wrist arthroplasty system, as well as foot and ankle, and knee products generally intended to restore a patient’s natural anatomy and movement. The company’s recently launched RevoMotion Reverse Shoulder Arthroplasty System (limited launch beginning early 2023) is a differentiated reverse shoulder implant system addressing the largest portion of the shoulder replacement market. These products often are used to treat patients with OA progression beyond where the company’s OA Pain Management products can allow the patients to retain an active lifestyle when early surgical intervention becomes preferable. The company commercializes its Joint Preservation and Restoration products principally by selling to hospitals and ASCs, through an independent network of sales representatives and distributors. Non-Orthopedic The company’s Non-Orthopedic product family consists of legacy HA-based products that are marketed principally for non-orthopedic applications. These products include Hyalobarrier, an anti-adhesion barrier indicated for use after abdominal-pelvic surgeries, Hyalomatrix, used for the treatment of complex wounds, such as burns and ulcers, as well as products used in connection with the treatment of ears, nose and throat disorders, 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 usually focused on injections, hospital operating rooms and ASCs, which are clinics outside of a normal hospital setting that are often at least partially physician-owned. These medical care delivery environments typically require different commercial approaches and have distinct call points, which requires diversity in the company’s sales approach. For instance, the company’s OA Pain Management product family and certain products in the company’s Non-Orthopedic category are almost entirely utilized in an office-based setting while the company’s Joint Preservation and Restoration and certain of the company’s Non-Orthopedic products are almost exclusively consumed in hospital operating rooms or ASCs. As a result of these distinctions, the company employs multiple sales models in the United States to ensure that the company is meeting the needs of the company’s customers and other healthcare system stakeholders. The company has maintained a mutually beneficial commercial partnership with Mitek, which sells Monovisc and Orthovisc in the United States. For this arrangement with Mitek, the company sells the Monovisc and Orthovisc products that the company manufactures to Mitek, and the company also receives from Mitek a royalty on their end user sales of these products in the United States. The company has the U.S. commercial partnerships for other products in the company’s OA Pain Management and Non-Orthopedic product families. Under these commercial partnerships, the company sells its products directly to its partners, who perform downstream sales and marketing activities to customers and end-users. In addition to a transfer price, the company may structure its arrangements to receive a royalty on end user sales. With the company’s expanded commercial infrastructure as a result of the Parcus Medical and Arthrosurface acquisitions, the company sells its Joint Preservation and Restoration family directly to clinicians, including hospitals and ASCs, through the company’s Anika sales team and large network of independent third-party distributors. Since the acquisitions, the company integrated its U.S. commercial organization, including cross training its sales team to sell the consolidated Joint Preservation and Restoration product portfolio. Within this framework, the company employs selling models that seek to maximize the benefit for the company’s company and customers, including in certain instances, contracts with group purchasing organizations and certain fixed-price delivery models. Outside of the United States, the company principally markets and sells its products using a worldwide network of commercial partners, along with a small number of direct sales representatives, to provide a solid foundation for future revenue growth and territorial expansion. The company’s relationships with these partners are generally structured such that the company sells its products to these partners directly while they, with global support from the company’s team, perform the in-country sales and marketing activities to drive growth and adoption of the company’s products locally. The company expects to generally maintain this model for the foreseeable future, while also selectively evaluating other options and being opportunistic about adopting other sales models, including direct sales, in certain jurisdictions. Research and Development For 2022, the company’s research and development expenses were $28.2 million. Intellectual Property ANIKA, ANIKA THERAPEUTICS, ANIKAVISC, ARTHROSURFACE, CINGAL, HYAFF, HYVISC, MONOVISC, ORTHOVISC, OVOMOTION, PARCUS MEDICAL, REVOMOTION, TACTOSET, WRISTMOTION, and X-TWIST are trademarks or registered trademarks of the company or its subsidiaries. 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 pursuant to the Federal Food, Drug, and Cosmetic Act, or FDCA, in the United States. Some of the company’s products are subject to premarket notification and clearance under section 510(k) of the FDCA. Some of the company’s devices are Class III devices that require PMA approval before they can be marketed. The delivery of the company’s products is subject to regulation by the U.S. Department of Health and Human services and other state and non-U.S. government agencies responsible for reimbursement and regulation of health care items and services. The company is subject to various U.S. federal and state laws pertaining to health care fraud and abuse, including anti-kickback, false claims, self-referrals, and other health care fraud. In addition, the company is subject to the U.S. federal and state transparency laws, such as the U.S. Physician Payments Sunshine Act, which require the company to annually disclose certain payments and other transfers of value the company makes to the U.S.-licensed health care practitioners (like physicians, nurse practitioners, advanced practice registered nurses, and others) and others. 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, or GDPR, in the European Union and the United Kingdom. Seasonality The company’s OA Pain Management and Non-Orthopedic product families are generally less seasonal in nature due to the nature of the company’s product mix and sales channels and strategies. In Joint Preservation and Restoration, procedure volumes are normally higher in the fourth quarter (year ended December 2022) due to several factors, including the satisfaction by patients of insurance deductible limits and the time of year patients prefer to have elective procedures. The ongoing effects of the COVID-19 pandemic have also somewhat changed the historic seasonality of the company’s Joint Preservation and Restoration business. These effects have included periodic restrictions on the performance of elective surgical procedures throughout the U.S. and global markets, the unavailability of physicians and/or changes to their treatment prioritizations, reductions in the levels of healthcare facility staffing and, in certain instances, the willingness or ability of patients to seek treatment. Competition For the company’s OA Pain Management products, the company’s principal competitors include Sanofi Genzyme, Zimmer Biomet, Inc., Bioventus Inc., Avanos Medical, Inc., and Ferring Pharmaceuticals. The company’s key competitors for its Joint Preservation and Restoration products include Arthrex, Inc., the DePuy Synthes Companies of Johnson & Johnson, Smith & Nephew PLC., Stryker Corporation, and Zimmer Biomet, Inc., as well as certain smaller organizations that focus on subsets of the larger industry, such as Catalyst OrthoScience, Enovis Corporation and Shoulder Innovations. History Anika Therapeutics, Inc. was founded in 1983. The company was incorporated in 1992.