Full Press Release Details
Reports Third Quarter 2016 Financial Results
Orthobiologics Revenue Increases 10% Year-over-Year
Earnings Per Share Increases to $0.59
BEDFORD, Mass.--(BUSINESS WIRE)--October 26, 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 third
quarter ended September 30, 2016, along with business progress in the
"We continued to deliver solid financial results in the third quarter,
while expanding globally and advancing our deep and differentiated
pipeline to drive sustained growth," said Charles H. Sherwood, Ph.D.,
President and Chief Executive Officer. "Last quarter, we had a
productive meeting with the FDA regarding the CINGAL regulatory
submission and continue to gain alignment on additional clinical and
non-clinical work required to bring this important treatment to the U.S.
Our confidence in the future success of CINGAL in the U.S. has been
reaffirmed by how well CINGAL has been received by physicians in Canada
and Europe, where we recently launched. We are well-positioned to
achieve our operational and financial objectives for 2016 and to create
significant near- and long-term value for patients and shareholders."
Third Quarter Financial Results
Total revenue for the third quarter of 2016 increased 9% to $25.8
million, compared to $23.7 million for the third quarter of 2015.
Worldwide Orthobiologics revenue grew 10% year-over-year in the third
quarter of 2016. MONOVISC revenue increased 33% year-over-year in the
third quarter of 2016, and it was the Company's main revenue growth
driver during the period.
International Orthobiologics revenue grew 27% year-over-year in the
first nine months of 2016 as a result of the Company's global
commercial expansion efforts. Domestically, we believe ORTHOVISC
maintained its position as the leading multiple-injection product
while MONOVISC continued to hold the number two position in the
single-injection segment.
Total operating expenses for the third quarter of 2016 were $12.1
million, compared to $10.5 million for the third quarter of 2015,
commensurate with the Company's growth in revenue, increased
commercial efforts, and active pipeline.
Net income for the third quarter of 2016 increased $0.6 million to
$9.0 million, or $0.59 per diluted share, compared to $8.4 million, or
$0.55 per diluted share, for the third quarter of 2015.
Recent Business Highlights
The Company made key commercial,
operational, pipeline, and financial advancements, including:
Meeting with the U.S. Food and Drug Administration (FDA) in late
September about the New Drug Application (NDA) for CINGAL, during
which the Company and FDA aligned on one additional Phase III clinical
trial to supplement the strong stable of existing pivotal data.
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.
Showcasing data from four recent studies evaluating the clinical
utility of our HA-based bioscaffold, HYALOFAST, at the 13th
World Congress of the International Cartilage Repair Society (ICRS).
Completing the Company's $25 million accelerated share repurchase
program, with a total of 531,067 shares repurchased by Anika.
Progressing with the consolidation of the Company's global
manufacturing operations at Anika's Bedford, Mass. global headquarters.
Conference Call Information
Anika's management will hold a
conference call and webcast to discuss its financial results and
business highlights tomorrow, Thursday, October 27th 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.
The Company has over two decades of global expertise developing,
manufacturing, and commercializing more than 20 products based on its
proprietary hyaluronic acid (HA) technology. Anika's orthopedic medicine
portfolio includes ORTHOVISC , MONOVISC ,
and CINGAL , which alleviate pain and restore joint
function by replenishing depleted HA, and HYALOFAST , a
solid HA-based scaffold to aid cartilage repair and regeneration. For
more information about Anika, please visit www.anikatherapeutics.com.
Forward-Looking Statements
The statements made in the last
sentence of the second paragraph of this press release, which are not
statements of historical fact, are forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended. These
statements include, but are not limited to, those relating to the
Company's future growth and creation of value, and the Company's ability
and positioning to meet its 2016 financial and operational goals. These
statements are based upon the current beliefs and expectations of the
Company's management and are subject to significant risks,
uncertainties, and other factors. The Company's actual results could
differ materially from any anticipated future results, performance, or
achievements described in the forward-looking statements as a result of
a number of factors including, but not limited to, (i) the Company's
ability to successfully commence and/or complete clinical trials of its
products on a timely basis or at all; (ii) the Company's ability to