Full Press Release Details
Therapeutics Reports Robust Financial Performance and Continued Progress
on Key Fronts in Third Quarter of 2015
Achieves 37.5% Year-over-Year Diluted EPS Growth in Quarter
BEDFORD, Mass.--(BUSINESS WIRE)--October 28, 2015--Anika Therapeutics,
Inc. (NASDAQ: ANIK), a global, integrated orthopedics medicines company
specializing in therapeutics based on its proprietary hyaluronic acid
("HA") technology, today reported financial results for the third
quarter ended September 30, 2015, along with business progress in the
"Our third quarter sales and profits were driven by strength in end-user
demand, which together with continuing pipeline progress, provides a
robust foundation for future growth," stated Charles H. Sherwood, Ph.D.,
President and Chief Executive Officer. "Our viscosupplementation
portfolio, anchored by ORTHOVISC and MONOVISC , continues to grow and
is poised to take and hold greater leadership in the market. We believe
this strong positioning, along with our steady pipeline progress during
the quarter, sets our company up to deliver financial results and
shareholder value for the long term."
Third Quarter Financial Results
Product revenue grew 8% in the third quarter of 2015.
ORTHOVISC and MONOVISC continued to command a strong position in the
market, with a combined share that grew modestly to 27% of the U.S.
viscosupplementation market at the end of the third quarter. ORTHOVISC
continues to maintain its market-leading position in the
multi-injection segment. MONOVISC holds the number two position in the
single-injection segment.
Total revenue for the third quarter of 2015 was $23.7 million,
compared with $22.1 million in the third quarter of 2014. The increase
was primarily driven by the continued growth in MONOVISC adoption in
Total operating expenses for the third quarter of 2015 were $10.5
million, compared with $11.8 million in the third quarter of 2014. The
decrease was primarily driven by lower cost of goods sold as a result
of favorable revenue mix, the full amortization of certain intangible
assets at the end of 2014, and certain employee termination-related
expenses in the third quarter of 2014.
Net income for the third quarter was $8.4 million, or $0.55 per
diluted share, compared with $6.2 million, or $0.40 per diluted share,
for the third quarter of 2014.
Recent Business Highlights
During the quarter, the Company continued making pipeline and
operational progress, including, as follows:
A formal meeting with the FDA's Office of Combination Products to
discuss a planned application to request a device designation for
CINGAL, followed by a formal written request for designation. A
decision from the FDA is expected by the end of the year.
The buildout of additional manufacturing space in, and the movement of
the Company's Italian manufacturing facilities to, Anika's Bedford,
Mass. global headquarters. This initiative is intended to consolidate
production for all the Company's products, and to accelerate product
The signing of a lease agreement by Anika's wholly-owned Italian
subsidiary, Anika Therapeutics S.r.l., to build office space in
Padova, Italy to serve as Anika's European headquarters. This site
will serve as Anika's European hub for sales, marketing, and
distribution and will also house administrative and product
development operations, and is intended to provide the Company with
infrastructure to support future growth.
Conference Call Information
Anika management will hold a conference call and webcast to discuss its
financial results, business highlights and financial outlook tomorrow,
Thursday, October 29th 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.
Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated
orthopedic medicines company based in Bedford, Mass. Anika is committed
to improving the lives of patients with degenerative orthopedic diseases
and traumatic conditions by providing clinically meaningful therapeutic
pain management solutions along the continuum of care, from palliative
care to regenerative medicine. The Company has over two decades of
expertise developing, manufacturing and commercializing more than 20
products, in markets across the globe, based on its proprietary
hyaluronic acid (HA) technology. Anika's orthopedic medicine portfolio
is comprised of marketed (ORTHOVISC and MONOVISC ) and pipeline
(CINGAL and HYALOFAST in the U.S.) products to alleviate pain and
restore joint function by replenishing depleted HA and aiding cartilage
repair and regeneration. For more information about Anika, please visit http://www.anikatherapeutics.com.
Forward-Looking Statements
The statements made in the second paragraph and the first bullet
point in the section captioned "Recent Business Highlights," 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 product pipeline and growth
opportunities and its leadership position in the viscosupplementation
market. 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 (i) the Company's ability
to successfully commence and/or complete clinical trials of its
products, including for HYALOFAST or for expanded indications of the
Company's MONOVISC product, on a timely basis or at all; (ii) the
Company's ability to obtain pre-clinical or clinical data to support
domestic and international pre-market approval applications or 510(k)
applications, or to timely file and receive FDA or other regulatory