Full Press Release Details
Reports Third Quarter 2017 Financial Results
Enrollment in CINGAL Phase III Clinical Trial;
of Regenerative Medicine Pipeline;
Revenue Increased 50% Year-over-Year
BEDFORD, Mass.--(BUSINESS WIRE)--October 25, 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 third
quarter ended September 30, 2017, along with business progress in the
"Anika made significant progress on multiple fronts executing its
long-term growth strategy, highlighted by the early completion of
enrollment in the CINGAL Phase III trial, regulatory clearances for the
expansion of MONOVISC into India, Australia, and Taiwan, pipeline
advancements and the bolstering of our executive and commercial
leadership team," said Charles H. Sherwood, Ph.D., Chief Executive
Officer. "MONOVISC continued to gain worldwide market share in the third
quarter as physicians continue to migrate towards single-injection
solutions, resulting in MONOVISC revenue growth of 50% year-over-year
for the quarter. Additionally, we advanced our regenerative medicine
pipeline with the submission of a 510(k) application to the U.S. Food
and Drug Administration for our injectable HA-based bone repair
treatment, a promising new opportunity gaining attention in the
Third Quarter Financial Results
Total revenue for the third quarter of 2017 increased 5%
year-over-year to $27.2 million, compared to $25.8 million for the
third quarter of 2016.
Worldwide Orthobiologics revenue grew 7% year-over-year in the third
quarter of 2017. The main driver of this product revenue growth was an
increase in global MONOVISC revenue of 50% year-over-year in the third
quarter of 2017, which was partially offset by the continued decline
in ORTHOVISC revenue in the same period, mirroring the industry shift
from multiple- to single-injection therapies.
International Orthobiologics revenue increased 10% year-over-year for
the third quarter of 2017, due primarily to the global expansion of
MONOVISC, as well as the growth of CINGAL. Domestically, ORTHOVISC and
MONOVISC continue to maintain a combined market-leading position.
Total operating expenses for the third quarter of 2017 were $16.9
million, compared to $12.1 million for the third quarter of 2016. The
increase in total operating expenses was due primarily to higher
research and development investments required to advance the Company's
growing pipeline towards regulatory approvals, and the expansion of
the commercial team in anticipation of those product launches.
Net income for the third quarter of 2017 was $6.9 million, or $0.46
per diluted share, compared to $9.0 million, or $0.59 per diluted
share, for the third quarter of 2016. The decline in net income was
due primarily to the planned increase in operating expenses previously
Recent Business Highlights
The Company made key commercial,
operational, pipeline, and financial advancements, including:
Completing enrollment well ahead of schedule in the second pivotal
Phase III trial evaluating CINGAL, the Company's novel
HA-corticosteroid combination viscosupplement for the treatment of
symptoms associated with osteoarthritis (OA) of the knee. The Phase
III trial, which will evaluate 576 patients with mild to moderate knee
osteoarthritis, is designed to evaluate the safety of CINGAL as well
as its effectiveness in improving pain, function, and quality of life
measures over a 26-week period, in comparison to MONOVISC and
triamcinolone hexacetonide. Enrollment was completed well ahead of
internal estimates largely due to physician and patient interest, and
enthusiasm surrounding the immediate and durable joint relief possible
Receiving regulatory approval for MONOVISC in India, Australia and
Taiwan for the treatment of pain associated with osteoarthritis of all
synovial joints. Sales in those countries are expected to begin in the
fourth quarter of 2017.
Advancing Anika's regenerative medicine pipeline with the submission
of a 510(k) application to the U.S. Food and Drug Administration for
its injectable HA-based bone repair treatment. This treatment provides
an injectable, self-setting, osteoconductive bone graft substitute
that resorbs and is replaced by the growth of new bone during the
Publishing data demonstrating the efficacy and safety of HYALOFAST in
combination with autologous adult mesenchymal stem cells for the
treatment of cartilage lesions on the knee in the peer-reviewed
journal Knee Surgery Sports Traumatology Arthroscopy.
Strengthening the Company's executive leadership team with the
appointments of Joseph Darling as President, Steven Chartier as Vice
President of Regulatory and Clinical Affairs, and the anticipated
appointment of Thomas Finnerty as Chief Human Resources Officer on
Continued progress towards full consolidation of the Company's global
manufacturing operations at Anika's Bedford, Massachusetts corporate
Conference Call Information
Anika's management will hold a
conference call and webcast to discuss its financial results and
business highlights tomorrow, Thursday, October 26th 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