Anika Therapeutics Posts 2Q16 Orthobiologic Revenue
Anika Therapeutics (ANIK) posted 2Q16 orthobiologic revenue of US $23.3MM, +20.9% vs. 2Q15, as-reported.
ORTHOVISC and MONOVISC viscosupplementation remained the principle growth drivers; the products maintained their U.S. segment positions: ORTHOVISC #1 in multiple-injections, MONOVISC #2 in single-injections. Leadership noted some price decline, though that was more than offset by increased unit sales.
Ex-U.S. growth of +36% was attributed to commercial expansion in Eastern EU, Middle East, Southeast Asia.
Within the quarter, ANIK launched CINGAL 3rd-gen viscosupplement in Canada (to be marketed by Pendopharm) and the EU, for the indication to treat OA pain. CINGAL contributed between $0.25MM and $0.5MM from initial orders.
Progress continued on the FastTRACK Phase III HYALOFAST study and the Phase III MONOVISC study for hip OA pain. (Note: FastTRACK does not indicate a fast-track designation from FDA)
ANIK obtained approval of Investigational Device Exemption for a Phase III clinical trial for tennis elbow pain: to enroll 185 patients at 20 U.S. and EU sites, starting 4Q16
Finally, leadership noted that Bioventus’ viscosupplementation product has not yielded competitive pressure for ANIK.
Sources: Anika Therapeutics, Inc.; ORTHOWORLD Inc.