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Anika Therapeutics Delivers Strong Performance With Record Product Revenue For The Fourth Quarter And Full Year 2015

The following excerpt is from the company's SEC filing.

Product Revenue Increased 43% Year-over-Year for Fourth Quarter of 2015

BEDFORD, Mass.--(BUSINESS WIRE)--February 24, 2016--Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today reported financial results for the fourth quarter and full year ended December 31, 2015, along with business progress in the periods.

“We ended 2015 and entered 2016 with strong momentum in all aspects of our business -- commercial, clin ical, operational, and financial,” said Charles H. Sherwood, Ph.D., President and Chief Executive Officer. “First, product revenue increased 43% year-over-year for the fourth quarter, and our viscosupplementation franchise delivered robust performance and remained on track for market leadership in 2017. Second, we continued to advance our late-stage HA-based pipeline candidates, CINGAL and HYALOFAST, through the clinical development and regulatory channels. Third, as part of our strategic shift towards direct commercialization, we are consolidating our global manufacturing operations at our U.S. headquarters. Finally, we renewed our interest in strategic M&A opportunities that could augment our thriving organic business, and create value for shareholders over the short and long terms.”

Fourth Quarter and Full Year Financial Results

Product revenue grew 43% year-over-year for the fourth quarter of 2015, and 16% for the full year of 2015. The Company saw normal inventory purchase growth patterns resume in the fourth quarter after the conclusion of an inventory rebalancing by its U.S. commercial partner.

Total revenue for the fourth quarter of 2015 increased 33% to $30.9 million, compared to $23.3 million for the fourth quarter of 2014. The increase was primarily driven by the continued growth in Anika’s viscosupplementation franchise worldwide. Total revenue for the full year of 2015 was $93.0 million, compared to $105.6 million for the full year of 2014. The decline was due to the receipt of $30 million of licensing, milestone and contract revenue related to MONOVISC product approval, launch, and achievement of a unique CMS reimbursement code in 2014, which was partially offset by $5 million of milestone revenue received in 2015 for the achievement of a target MONOVISC U.S. end user sales threshold.

ORTHOVISC maintained its position as the leading multiple-injection product. MONOVISC continued to hold the number two position in the single-injection segment. Overall, there was a 24% increase in the combined U.S. viscosupplementation end-user revenue in 2015, with MONOVISC end-user sales more than tripling year-over-year domestically.

The Company received a $5.0 million milestone payment in the fourth quarter of 2015 from its U.S. commercial partner as a result of MONOVISC achieving $50 million in end-user revenue in 2015.

Net income for the fourth quarter of 2015 increased 41% to $11.0 million, or $0.72 per diluted share, compared to $7.8 million, or $0.51 per diluted share, for the fourth quarter of 2014. Net income for the full year of 2015 was $30.8 million, or $2.01 per diluted share, compared to $38.3 million, or $2.51 per diluted share. Full-year 2014 results reflected the favorable impact of the $30 million of licensing, milestone and contract revenue previously discussed.

Recent Business Highlights

The Company made key pipeline, commercial, operational, and financial advancements, including:

The commencement of patient enrollment in the Company’s HYALOFAST FastTRACK study. HYALOFAST, a biodegradable scaffold, is used to enable cartilage regeneration in patients suffering from cartilage defects. The FastTRACK study is a prospective, randomized, active treatment-controlled, multicenter study to establish the superiority of a hyaluronan-based scaffold (HYALOFAST) with autologous bone marrow aspirate concentrate (BMAC) in the treatment of articular knee cartilage defect lesions. It will enroll approximately 200 patients at up to 30 sites in the U.S. and Europe. HYALOFAST is CE Marked in Europe and is available commercially in 18 countries with more than 6,000 uses to date. European clinical data demonstrates that patients treated with HYALOFAST plus autologous BMAC in a one-step, minimally invasive arthroscopic procedure were able to successfully regenerate...