Anika Therapeutics Reports 3Q16 Orthobiologic Revenue
Anika Therapeutics posted 3Q16 orthobiologic revenue of US $22.4MM, +9.6% vs. 3Q15, as-reported.
- MONOVISC revenue +33% vs. 3Q15, attributed to volume and market share increase; was main growth driver in 3Q16
- Future MONOVISC growth will be supported by geographic expansion ex-U.S.; recently partnered with DePuy Mitek for distribution in Brazil (on both MONOVISC and ORTHOVISC); working through regulatory process with partners in China
- ORTHOVISC maintained its position as #1 multiple-injection viscosupplement, while MONOVISC maintained #2 in single-injection products
- U.S. end-user revenue pressured by strategic pricing initiatives by Mitek, intended to secure new/larger accounts to grow market share
- Enrollment continues in FastTRACK Phase III HYALOFAST study for cartilage repair and Phase III MONOVISC hip OA study
CINGAL New Drug Application update:
- Product contributed ~$0.5MM-$1MM to quarterly revenue
- September 2016 meeting with FDA resulted in alignment on additional Phase III clinical trial to supplement existing pivotal data; expecting CINGAL Investigational New Drug application by early 2017, with approval in late 2018/early 2019
- CINGAL is available in ~10 countries, with Canada and Germany launches noted as most successful to date
- Will submit CINGAL regulatory packages in India and Australia by year-end
Sources: Anika Therapeutics, Inc.; ORTHOWORLD Inc.