Full Press Release Details
Reports Second Quarter 2018 Financial Results
Top and Bottom Line Performance with 8% Product Revenue Growth and $0.68
Leadership Added to Optimize Commercial Reach and Operating Efficiency
Initiatives Ongoing to Gain U.S. Regulatory Approval of CINGAL
BEDFORD, Mass.--(BUSINESS WIRE)--July 25, 2018--Anika Therapeutics, Inc.
(NASDAQ: ANIK), a global, integrated orthopedic and regenerative
medicines company specializing in therapeutics based on its proprietary
hyaluronic acid ("HA") technology, today reported financial results for
the second quarter ended June 30, 2018, along with business progress in
"Anika's strategic initiatives in the second quarter were focused on
opportunities to accelerate revenue growth in 2019 and beyond," said
Joseph Darling, President and Chief Executive Officer of Anika
Therapeutics. "We strengthened our senior leadership team, increased our
focus on strategic M&A, and began executing on multiple strategies to
gain U.S. regulatory approval of CINGAL. Bringing CINGAL to U.S.
patients and physicians remains one of Anika's top strategic priorities.
We are committed to both maximizing our current business opportunities
and pursuing new growth initiatives to create near- and long-term value
Second Quarter Financial Results
Product revenue increased 8% year-over-year in the second quarter of
2018, due primarily to higher MONOVISC revenue in the U.S. Global
MONOVISC revenue increased 26% year-over-year in the second quarter of
U.S. Viscosupplementation revenue increased $2.3 million
year-over-year for the second quarter of 2018. International
Viscosupplementation revenue decreased $0.7 million year-over-year for
the second quarter of 2018, due primarily to the timing of orders.
Domestically, ORTHOVISC and MONOVISC maintained the number one
position in the combined multi- and single-injection segments in the
second quarter of 2018.
Total revenue for the second quarter of 2018 was $30.5 million,
compared to $33.5 million for the second quarter of 2017. The
year-over-year decline was due to the achievement of $5.0 million of
milestone revenue in the second quarter of 2017, as a result of
MONOVISC reaching $100 million in U.S. end-user sales within a
consecutive 12-month period.
Total operating expenses for the second quarter of 2018 were $19.3
million, compared to $15.7 million for the second quarter of 2017. The
increase in total operating expenses was due primarily to product
revenue growth, increased personnel costs, and expanded worldwide
commercial initiatives.
Net income for the second quarter of 2018 was $10.1 million, or $0.68
per diluted share, compared to $11.4 million, or $0.76 per diluted
share, for the second quarter of 2017. The decline in net income was
due primarily to the increase in operating expenses previously
Recent Business Highlights
Announced that initial top-line results for the CINGAL 16-02 clinical
trial, an active-comparator Phase III study conducted to support U.S.
approval, did not reach statistical significance, although it did
maintain the durability of strong pain relief throughout the 26 weeks,
consistently demonstrating the long-term benefits of CINGAL. The
magnitude of pain reduction demonstrated incremental improvement
compared to the previous CINGAL Phase III study, and the duration of
patient improvement after CINGAL injection was maintained near peak
levels throughout the 26-week study. Anika has engaged external
regulatory and legal experts to assist in the strategic approach for
seeking CINGAL approval in the U.S. market. Anika remains fully
committed to working closely with regulators to gain U.S. approval of
Strengthened the senior leadership management team with the newly
created position of Vice President of International Sales based in
Europe to maximize sales impact and optimize the Company's commercial
reach in our foreign markets.
Added a new Vice President of Operations to senior leadership team to
focus on operation efficiency and margin improvements.
Redirected internal efforts of Chief Technology and Strategy Officer
with spear-heading the assessment of strategic M&A opportunities.
Completed the Company's $30 million accelerated share repurchase
program in July, under which Anika repurchased approximately 800,000
shares of its outstanding common stock.
Full Year 2018 Revised Corporate Outlook
available information, the Company revised its guidance for the full
year of 2018. Anika currently does not expect licensing, milestone and
contract revenue of $5.0 million in 2018. The Company continues to
anticipate product revenue to be flat for the full year of 2018. The
Company continues to expect that it will resume the shipment of products
that were the subject of the previously-disclosed voluntary recall by
the end of this year. Total operating expenses are now expected to be in
the low $90 million range for the full year of 2018, adjusted for the
reduction of CINGAL pre-launch marketing expenses.
Conference Call Information
Anika's management will hold a
conference call and webcast to discuss its financial results and
business highlights tomorrow, Thursday, July 26 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 and regenerative
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
tissue 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