Full Press Release Details
Reports Second Quarter 2016 Financial Results
Revenue Increases 16% Year-over-Year
BEDFORD, Mass.--(BUSINESS WIRE)--July 27, 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 second
quarter ended June 30, 2016, along with business progress in the period.
"We continued our strong momentum in the second quarter, with total
revenue growth of 16% year- over-year for the quarter," said Charles H.
Sherwood, Ph.D., President and Chief Executive Officer. "MONOVISC end
user demand remained strong, we achieved important milestones in our
global expansion with the launch of CINGAL in Canada and Europe, and we
continued to advance our deep and differentiated pipeline. We are
well-positioned to drive future growth and create significant near- and
long-term value for patients and shareholders."
Second Quarter Financial Results
Total revenue for the second quarter of 2016 increased 16% to $26.6
million, compared to $22.9 million for the second quarter of 2015.
Worldwide Orthobiologics revenue grew 21% year-over-year in the second
quarter of 2016. ORTHOVISC and MONOVISC, our lead viscosupplementation
products in the Orthobiologics franchise, continued to be the main
International Orthobiologics revenue grew 36% year-over-year in the
second quarter of 2016 as a result of our global commercial expansion
efforts. Domestically, ORTHOVISC maintained its position as the
leading multiple-injection product. MONOVISC continued to hold the
number two position in the single-injection segment.
Total operating expenses for the second quarter of 2016 were $13.1
million, compared to $10.5 million for the second quarter of 2015.
Net income for the second quarter of 2016 increased $0.8 million to
$8.6 million, or $0.57 per diluted share, compared to $7.8 million, or
$0.51 per diluted share, for the second quarter of 2015.
Recent Business Highlights
The Company made key commercial, operational, pipeline, and financial
advancements, including:
Commercially launching CINGAL, the Company's third generation
viscosupplement, in Europe and Canada to treat pain associated with
Advancing its product pipeline with continued progress on the
FastTRACK Phase III HYALOFAST Study, as well as the Phase III MONOVISC
study for the treatment of osteoarthritis pain in the hip.
Submitting and obtaining approval of an investigational device
exemption to conduct a Phase III clinical trial for the treatment of
pain associated with lateral epicondylosis, or tennis elbow. The study
plans to enroll 185 patients across approximately 20 investigational
sites in the U.S. and Europe beginning in the fourth quarter of 2016.
Continuing to execute the Company's $25 million accelerated share
repurchase program, with completion expected in August 2016.
Progressing with the full integration of the Company's global
manufacturing operations under one roof in 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, July 28th
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 www.anikatherapeutics.com.
Forward-Looking Statements
The statements made in the third and fourth bullet points 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 advancement of its pipeline, the
Company's enrollment plans for its lateral epicondylosis clinical trial,
and the expected timeline for completion of the Company's accelerated
share repurchase program. 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 obtain pre-clinical or clinical data to support
domestic and international pre-market approval applications, 510(k)
applications, or new drug applications, or to timely file and receive
FDA or other regulatory approvals or clearances of its products; (iii)
that such approvals will not be obtained in a timely manner or without
the need for additional clinical trials, other testing or regulatory
submissions, as applicable; (iv) the Company's research and product
development efforts and their relative success, including whether we