Full Press Release Details
Reports Fourth Quarter and Full Year 2016 Financial Results
Orthobiologics Revenue Increases 13% Year-over-Year for Fourth Quarter
Revenue Grows 17% for Full Year of 2016
BEDFORD, Mass.--(BUSINESS WIRE)--February 15, 2017--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, 2016, along with business
progress in the periods.
"Anika delivered another year of very strong growth, with 17% product
revenue growth for the full year of 2016," said Charles H. Sherwood,
Ph.D., President and Chief Executive Officer. "We also submitted an IND
application to the FDA to initiate an additional Phase III clinical
trial of CINGAL, and we received CE Mark approval for ORTHOVISC-T in the
fourth quarter, paving the way for our next generation of growth
drivers. We expect to commence the CINGAL Phase III trial and launch
ORTHOVISC-T in Europe in the first half of 2017. Our strategic
objectives in 2017 are focused on global commercial expansion, pipeline
advancement, infrastructure enhancements and strategic M&A to drive
sustained growth and create value for patients and shareholders."
Fourth Quarter and Full Year Financial Results
Product revenue increased 11% for the fourth quarter of 2016, and 17%
for the full year of 2016, as compared to the same periods in 2015.
Total revenue for the fourth quarter of 2016 was $28.7 million,
compared to $30.9 million for the fourth quarter of 2015. The decline
was due to the achievement of $5 million of contractual milestone
revenue in the fourth quarter of 2015 for reaching a targeted MONOVISC
U.S. end user sales threshold. Total revenue for the full year of 2016
grew 11% to $103.4 million, compared to $93.0 million for the full
Worldwide Orthobiologics revenue increased 13% year-over-year in the
fourth quarter of 2016. For the full year of 2016, worldwide
Orthobiologics revenue increased 22% and MONOVISC revenue grew 54%,
which was the main overall revenue growth driver.
International Orthobiologics revenue increased 24% for the full year
of 2016, due primarily to the global expansion of MONOVISC.
Domestically, ORTHOVISC and MONOVISC continue to maintain a market
Total operating expenses for the fourth quarter of 2016 were $16.0
million, compared to $13.8 million for the fourth quarter of 2015,
commensurate with the growth in product revenue, expanded commercial
efforts and active pipeline development. Total operating expenses for
the full year of 2016 were $52.8 million, compared to $44.9 million
for the full year of 2015.
Net income for the fourth quarter of 2016 was $8.1 million, or $0.54
per diluted share, compared to $11.0 million, or $0.72 per diluted
share, for the fourth quarter of 2015. Fourth quarter 2015 results
reflected the favorable impact of the $5 million of licensing,
milestone and contract revenue previously discussed. Net income for
the full year of 2016 increased $1.8 million to $32.5 million, or
$2.15 per diluted share, compared to $30.8 million, or $2.01 per
diluted share, for the full year of 2015.
Recent Business Highlights
The Company made key commercial,
operational, pipeline, and financial advancements, including:
Submitting an Investigational New Drug (IND) application to the U.S.
Food and Drug Administration (FDA) to initiate an additional Phase III
clinical trial of CINGAL.
Receiving CE Mark approval for a treatment, which will be marketed
internationally as ORTHOVISC-T, indicated to relieve pain and restore
function in tendons affected by chronic lateral epicondylosis.
Advancing its product pipeline with continued progress on enrolling
patients in the FastTRACK Phase III HYALOFAST Study for cartilage
repair, as well as the Phase III MONOVISC study for the treatment of
osteoarthritis pain in the hip.
Progressing with the consolidation of the Company's global
manufacturing operations at Anika's Bedford, Massachusetts corporate
Full Year 2017 Corporate Outlook
Looking forward to 2017, the
Company expects total revenue growth to be in the mid-teen percentage
range for the full year of 2017. Licensing, milestone and contract
revenue is expected to be $5 million for the year. The Company also
anticipates continued headway on several key initiatives including:
Commencement of the Phase III clinical trial of CINGAL, to supplement
the strong stable of existing pivotal data.
Launch of ORTHOVISC-T in Europe, and the initiation of a Phase III
clinical trial for U.S. approval of the treatment.
International expansion of MONOVISC and CINGAL.
Continued progress toward full patient enrollment in the FastTRACK
Phase III HYALOFAST study, with over 50% of the total patient
population enrolled by the end of 2017.
Completion of the consolidation of the Company's global manufacturing
operations at Anika's Bedford, Massachusetts corporate headquarters.
Continued progress toward the development of a direct
commercialization capability in the U.S.
Conference Call Information
Anika's management will hold a
conference call and webcast to discuss its financial results and
business highlights tomorrow, Thursday, February 16th 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 website. A replay of the
webcast will be available on Anika's website approximately two hours
after the completion of the event.
About Anika Therapeutics, Inc.
Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company
based in Bedford, Massachusetts. Anika is committed to improving the
lives of patients with degenerative orthopedic diseases and traumatic
conditions with clinically meaningful therapies along the continuum of
care, from palliative pain management to regenerative cartilage repair.