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Product / Company Performance

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.

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