Full Press Release Details
Therapeutics Reports Record Revenue for 2008
Revenue Grows 16% as Product Revenue Increases 23% for Full Year
Accomplishments Include New Product Launches, Pipeline Achievements and
Investments in New Manufacturing Facility to Accommodate Future Growth
BEDFORD, Mass.--(BUSINESS WIRE)--March 5, 2009--Anika Therapeutics, Inc.
(Nasdaq: ANIK), a leader in products for tissue protection, healing and
repair based on hyaluronic acid ("HA") technology, today reported record
revenue for the year ending December 31, 2008.
During the fourth quarter Anika continued to strengthen its global
position in joint health therapies with the domestic and international
expansion of its flagship joint health product, ORTHOVISC ,
and the completion of enrollment for its U.S. clinical study of MONOVISC ,
Anika's single-injection osteoarthritis product. The Company also
continued to invest in its future growth through its new manufacturing
facility and product development initiatives.
Anika reported product revenue of $8,285,000 for the fourth quarter of
2008 compared with $7,916,000 in the same period last year. For the year
ended December 31, 2008, product revenue increased to $33,055,000,
compared with $26,905,000 for full year 2007. The increase in product
revenue for the quarter and the year was primarily attributable to
strong sales of ORTHOVISC in the U.S. as well as sales of MONOVISC in
Total revenue for the fourth quarter of 2008 was $8,966,000, compared
with $9,627,000 in the fourth quarter of 2007. Revenue for the fourth
quarter of 2007 included $1.2 million in revenue related to the
Company's termination settlement with Galderma. For the year ended
December 31, 2008, total revenue was a record $35,780,000, compared with
$30,830,000 in 2007.
Product Gross Margin
Product gross margin for the fourth quarter of 2008 increased to 66%
from 59% in last year's fourth quarter. Product gross margin for the
year ended December 31, 2008 was 60% versus 56% for full year 2007. The
quarter and full year improvements in gross margins were due primarily
to unit growth and strong worldwide ORTHOVISC revenue, as well as the
impact of sales from new products.
Other Operating Expenses
Research and development expense for the fourth quarter of 2008
increased to $2,445,000 compared with $1,395,000 for the same period
last year. Research and development expense for the year ended December
31, 2008 increased to $7,399,000 compared with $4,365,000 for full year
2007. The quarter and full-year increases were primarily due to clinical
trials in the U.S. and Europe for MONOVISC, manufacturing scale-up
activities for ELEVESS and MONOVISC, and development activities in joint
Selling, general and administrative expense for the fourth quarter of
2008 decreased to $2,450,000 from $2,885,000 for the same period last
year, primarily due to unusually high legal, recruiting and consulting
expenses in the fourth quarter of 2007. Selling, general and
administrative expense for the year ended December 31, 2008 increased to
$10,965,000 from $7,997,000 for full year 2007. The increase was due to
the following three factors: 1) increased personnel costs and marketing
expenses in connection with the Company's joint health franchise; 2)
higher costs at Anika's Bedford facility due to a full year of occupancy
and lease payments in 2008 versus only a partial year of payments and
occupancy for 2007; and 3) higher year-over-year professional costs
related to strategic and other corporate projects.
Net income for the fourth quarter of 2008 was $1,095,000, or $0.10 per
diluted share, compared with $1,673,000, or $0.15 per diluted share, for
the same period last year. Net income for the year ended December 31,
2008 was $3,629,000, or $0.32 per diluted share, compared with
$6,035,000, or $0.53 per diluted share, in 2007. The decrease in net
income in both the fourth quarter and full year periods was due to
higher operating expenses, as well as lower interest income.
Anika's cash, cash equivalents and short-term investments at December
31, 2008 were $43,194,000 compared with $39,405,000 at December 31,
2007. The increase was a result of the final drawdown in the fourth
quarter of 2008 under the Company's line-of-credit, partly offset by
lower accounts payable.
Management Commentary
"Anika made excellent financial and operational progress in 2008," said
Charles H. Sherwood, Ph.D., Anika's president and chief executive
officer. "We completed our sixth-consecutive profitable year, grew
product revenue by 23 %, and delivered record ORTHOVISC product revenue.
During the year, we introduced two new products to the European market,
including MONOVISC, our single-injection osteoarthritis product, and
ORTHOVISC mini, our hyaluronic acid-based osteoarthritis
treatment specifically targeted to treat smaller joints. We also
completed enrollment of our U.S. pivotal clinical trial for MONOVISC and
received positive six-month data from our ongoing trial in Europe. One
of the key achievements of the year was the progress we made on our new
manufacturing facility, which will provide us with much-needed capacity
as we capitalize on expected demand for our new products."
"We concluded a successful 2008 with another quarter of strong operating
performance," said Sherwood. "We achieved record U.S. sales in the
fourth quarter for our ORTHOVISC product line and achieved our
highest-ever annual product gross margin at 60% for the year. We also
expanded the geographic reach of our joint-health franchise with
distributors in Europe, the Middle East and Southeast Asia."
"We are excited about our prospects in 2009 and beyond," said Sherwood.
"We are continuing to gain market share for our joint health products
and expect this trend to continue both domestically and abroad. In
addition to continuing to grow sales of ORTHOVISC, we also plan to
increase the market penetration of MONOVISC and ORTHOVISC mini in
Europe, and file for marketing approval for MONOVISC in the U.S. Another
pipeline milestone we expect to achieve this year is submitting a CE
Mark application for CINGAL , our new single injection joint health
product with an active therapeutic molecule for pain relief. We also are
optimistic about the long-term prospects for ELEVESS, our HA-based
soft-tissue filler for facial wrinkles and scar remediation, and plan to
expand distribution for this product over the balance of this year.
Finally, by the end of 2009 we expect to begin manufacturing at our new
state-of-the-art facility. We look forward to 2009 with confidence in