Anika Therapeutics Announces First Annual Profit - and FDA approval for OrthoVisc®
BY ROBIN R. YOUNG CFA, MARCH 1, 2004
The Acid Test for early stage Medical Device companies is profitability, before obtaining FDA approval for the core product. It's an almost impossible feat, yet a couple companies have accomplished this over the years; Vascular Solutions almost seven years ago.; St. Jude Medical over twenty years ago; and Anika Therapeutics last week.
Headquartered in Woburn, MA, Anika Therapeutics, Inc. develops, manufactures and commercializes therapeutic products based on hyaluronic acid (HA), a naturally occurring, biocompatible polymer found throughout the body. Revenues for 2003 were $15.4 million, up 17% from the prior year's levels. Anika's revenues come from a selling various forms of its HA for ophthalmic use in the U.S., equine osteoarthritis everywhere and OrthoVisc®, for human osteoarthritis of the knee outside the U.S.
Anika's home run product is expected to be OrthoVisc®, which would compete directly with Genzyme's Synvisc, a $100 million+ revenue product distributed by Wyeth Ayers.
Last month (February) the FDA granted Anika final marketing approval for OrthoVisc®. JNJ's Ortho Biotech signed on to market it.
For its final year before FDA approval of OrthoVisc®, Anika was able to post earnings of $800,000.
With approval and a distribution agreement in place, 2004 will be a break-out year.
