Full Press Release Details
Therapeutics Delivers Solid Second Quarter 2015 Financial Results and
Continued Pipeline Progress
in Quarter Driven by Continued Adoption of Orthobiologics Products;
ORTHOVISC and MONOVISC U.S. Market Share Surpasses 25%
BEDFORD, Mass.--(BUSINESS WIRE)--July 29, 2015--Anika Therapeutics, Inc.
(NASDAQ: ANIK), a leader in products for tissue protection, healing, and
repair based on hyaluronic acid (HA) technology, today reported
financial results for the second quarter ended June 30, 2015, along with
business progress in the period.
"The solid results we delivered in the second quarter demonstrate
accelerating demand, which combined with our tangible pipeline progress,
positions Anika to deliver robust growth for many years," stated Charles
H. Sherwood, Ph.D., President and Chief Executive Officer. "As in recent
quarters, physician and patient demand for our homegrown orthobiologics
products continued to gain traction, and was the highlight of our
commercial results. We expect that trend to continue with the launch of
two important orthopedic products in the coming years, which will
provide an important catalyst for additional value creation."
Second Quarter Financial Results
Product revenue was up 8 percent in 2015.
At the end of the quarter, ORTHOVISC and MONOVISC achieved a combined
26 percent share of the U.S. viscosupplementation market. ORTHOVISC
continues to grow and is maintaining its market-leading position in
the multi-injection segment. MONOVISC experienced accelerated growth,
and now holds the number two position in the single-injection segment.
Total revenue for the second quarter of 2015 was $22.9 million. In
last year's second quarter, the Company reported $5 million in
milestone revenue from the first commercial sale of MONOVISC in the
U.S., resulting in total revenue of $26.3 million.
Total operating expenses for the second quarter of 2015 were $10.5
million compared with $11.1 million in the second quarter of 2014. The
decrease was primarily driven by lower SG&A expenses as a result of
the full amortization of certain intangible assets at the end of 2014.
Net income for the second quarter was $7.8 million, or $0.51 per
diluted share, compared with $9.3 million, or $0.60 per diluted share,
for the second quarter of 2014. Last year's results included $5
million in milestone revenue as a result of the first commercial sale
of MONOVISC in the U.S. Excluding the impact of this milestone
revenue, net income and diluted EPS increased $1.6 million, and $0.11,
Recent Business Highlights
The Company continues to make solid headway in expanding the commercial
reach of existing products and advancing the progress of products in its
development pipeline. Recent highlights of the business include:
Agreements with new partners in India and Australia for the
commercialization of MONOVISC.
Submission and approval of an investigational device exemption (IDE)
to evaluate the utility of MONOVISC, the Company's single-injection
product, in treating hip pain associated with osteoarthritis. The
study is sponsored by Anika's exclusive U.S. commercial partner for
MONOVISC, and is expected to commence patient enrollment in the U.S.
before the end of this year.
Positive results from a 242-patient study evaluating the safety of a
repeat injection of CINGAL, the first viscosupplement to combine the
HA formulation found in MONOVISC with a steroid into a single
injection to treat pain and reduce inflammation caused by
osteoarthritis. The results of this follow-up study combined with the
initial Phase 3 data suggest that CINGAL retains an excellent safety
profile as an initial injection as well as a repeat injection. CINGAL
is currently progressing through the regulatory process in the U.S.,
Approval of a HYALOFAST IDE by the U.S. FDA. HYALOFAST, a
biodegradable 3D scaffold that enables cartilage regeneration, has
been used in more than 6,000 patients outside of the U.S. via a
non-invasive, single-step arthroscopic procedure. HYALOFAST is
commercially available in 18 countries. With approval of this IDE, the
Company is on track to commence patient enrollment at sites in the
United States and Europe beginning in the fourth quarter of 2015.
During the quarter, Anika further established its commitment to
developing the next generation of orthopedic medicine, announcing a
multiyear research collaboration with the University of Massachusetts
(UMass) Amherst to develop a novel treatment for rheumatoid arthritis
(RA). This partnership combines Anika's proprietary HA technology with
UMass Amherst's preclinical research and scientific expertise with the
goal to develop the first localized therapy for RA that is
cost-effective and can have a systemic impact on a large patient
population with currently limited treatment options.
Conference Call Information
Anika management will hold a conference call and webcast to discuss its
financial results, business highlights and financial outlook tomorrow,
Thursday, July 30th 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.
Headquartered in Bedford, Mass., Anika Therapeutics, Inc. develops,
manufactures, and commercializes therapeutic products for tissue
protection, healing, and repair. These products are based on hyaluronic
acid (HA), a naturally occurring, biocompatible polymer found throughout
the body. Anika's products range from orthopedic/joint health solutions
led by ORTHOVISC and MONOVISC, treatments for osteoarthritis, to
surgical aids in the anti-adhesion and ophthalmic fields. The Company
also offers aesthetic dermal fillers for the correction of facial
wrinkles. Anika's Italian subsidiary, Anika Therapeutics S.r.l.,
provides complementary HA products in orthopedic/joint health and
anti-adhesion, as well as therapeutics in areas such as advanced wound
treatment and ear, nose and throat care. Its regenerative technology
advances Anika's vision to offer therapeutic products and medical
solutions that go beyond pain relief to protect and restore damaged