Full Press Release Details
Therapeutics Delivers Strong Performance with Record Product Revenue for
the Fourth Quarter and Full Year 2015
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, clinical, 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
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
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
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
hyaline-like cartilage. We believe HYALOFAST is poised to take a
market leadership position.
The decision to pursue CINGAL approval in the U.S. through the New
Drug Application pathway, and the approval of CINGAL by Health Canada
for the treatment of pain associated with osteoarthritis of the knee.
An agreement with a new commercial partner in China for the
commercialization of both MONOVISC and CINGAL.
Ongoing progress with full integration of the Company's global
manufacturing operations under one roof in Anika's Bedford, Mass.
global headquarters. This integration is intended to accelerate
product development and to enable full control of the Company's supply
Full Year 2016 Corporate Outlook
Looking forward to 2016, the Company expects total revenue growth to be
in the mid-teen percentage range. The Company also anticipates continued
headway on several key initiatives including:
Resolution of open items for the submission of CINGAL New Drug
Approval of CINGAL in the E.U. and launch of CINGAL in Canada and
Advancement toward full patient enrollment in the Company's HYALOFAST
Integration of global manufacturing operations in Anika's Bedford,
Mass. global headquarters.
Initial occupation of the Company's new Padua, Italy office, which
will serve as its new European hub.
Progress in the development of a direct commercialization capability
Conference Call Information
Anika management will hold a conference call and webcast to discuss its
financial results, business highlights and financial outlook tomorrow,
Thursday, February 25th at 9:00 am ET. The conference call
can be accessed by dialing 1-855-468-0611 (toll-free domestic) or
1-484-756-4332 (international). A live audio webcast will be available
in the "Investor Relations" section of Anika's website, www.anikatherapeutics.com.
An accompanying slide presentation may also be accessed via the Anika