Shares of biotechnology company Anika Therapeutics Inc. (ANIK) have gained more than 40 percent in the last one year and trade around $9. The company is involved in developing therapeutic products for tissue protection, healing and repair, based on hyaluronic acid, or HA, a naturally occurring, biocompatible polymer in the body.
The company's first osteoarthritis product based on its proprietary cross-linked hyaluronic acid-technology is Monovisc, a single injection viscosupplement approved for the treatment of symptoms of osteoarthritis and for the relief of joint pain in all synovial joints. The product was commercially launched in Europe in 2008 and is distributed in 18 countries including, Canada and Middle Eastern nations.
In the U.S., Monovisc is still under FDA review. Anika submitted its premarket approval filing for Monovisc in December 2009 but was issued a deficiency/non-approvable letter. Despite submission of additional data and analyses in 2010, the company was informed by the FDA that deficiencies remain. During the first quarter of 2011, Anika requested a review by the Advisory Panel to assist in the resolution of any remaining issues and is in ongoing dialogue with the U.S. regulatory agency.
According to Anika, Monovisc product revenue has significantly increased over the years in Europe, thanks to increasing market awareness and expansion of the company's EU distribution channel.
The company is also developing another single-injection osteoarthritis product named Cingal , which is based on the same technology platform as that of Monovisc, with an added active therapeutic molecule to provide broad pain relief for an extended period of time.
Some of the other marketed orthobiologic products of Anika include, Orthovisc, approved for use in the knee in the United States, and for use in all synovial joints in the European Economic Area; Orthovisc mini, approved for use in small joints such as the thumb, big toe and ankle only in the European Economic Area; Hyalograft C Autograft for cartilage regeneration; Hyalofast, a biodegradable support for human bone marrow mesenchymal stem cells; Hyalonect, a woven gauze used as a graft wrap; Hyaloglide, an auto cross-linked Hyaluronic Acid gel used in tenolysis treatment ( a surgical release of a tendon from adhesions, typically in the hand or wrist), all of which are available in Europe.
It is not only orthobiologics that Anika has forayed into. The company has a diverse product portfolio covering a broad range of therapeutic applications namely, dermal, ophthalmic, veterinary and surgical. The Elevess family of cosmetic dermatology products for facial wrinkles, scar remediation and lip augmentation; Amvisc, Amvisc Plus, Staarvisc II, Optivisc injectable viscoelastic HA products for ophthalmic surgery; Incert, an HA-based anti-adhesive for surgical applications and Hyvisc for the treatment of joint dysfunction in horses associated with equine osteoarthritis are part of the company's armamentarium.
The company's products are commercialized directly and through a network of distributors. Anika's list of distributors both in the United States and around the world reads like a who's-who of business , including Bausch & Lomb Surgical Inc., Medtronic, Boehringer Ingelheim Vetmedica, Inc., DePuy Mitek, Inc., division of Johnson & Johnson, Staar Surgical Co., and Hoya Surgical Optics.
Helped by a strong demand for its products and expanding international distribution network , Anika's product revenue has increased over the years. The product revenue, which was $33.1 million in 2008, rose to $37.3 million in 2009 and $52.7 million in 2010. In the nine months ended September 30, 2011, the product revenue was $44.2 million.
The company earned $3.6 million or $0.32 per share in 2008, $3.7 million or $0.32 per share in 2009 and $4.3 million or $0.32 per share in 2010. In the nine months ended September 30, 2011, the company's net income was $5.58 million or $0.41 per share. Anika has been consistently profitable since 2003.
At September 30, 2011, Anika had $29.0 million in cash, up from $28.2 million at December 31, 2010, mainly as a result of increased profits.
Founded in in 1993 as a public company, Anika Therapeutics is a spin off of the hyaluronic acid business of MedChem Products Inc.
In the last 1 year, ANIK has thus far hit a low of $5.24 and a high of $11.67. The stock closed Wednesday's trading at $9.56, up 2.69%.
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