Full Press Release Details
Therapeutics Reports 18% Revenue Growth in Fourth-Quarter 2009
Unit Sales of ORTHOVISC
to Record Quarterly Level
Health Revenue Increases 17% in Fourth Quarter
BEDFORD, Mass.--(BUSINESS WIRE)--March 16, 2010--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 quarter and year ended December 31,
Obtained robust growth platform with acquisition of Fidia Advanced
Increased total revenue and product revenue by 18% and 20% in fourth
quarter, respectively
Joint health revenue grew by 17% in fourth quarter and 22% for the
full year, driven by strong domestic sales of ORTHOVISC
Submitted final module for MONOVISC PMA filing with FDA
Anika's product revenue increased by 20% to $9,944,000 for the fourth
quarter of 2009, compared with $8,285,000 in the same period last year.
Product revenue for the full year of 2009 grew 13% to $37,321,000 from
$33,055,000 in 2008. The increase in product revenue for the quarter and
year-end periods was attributable to strong sales of the Company's
ORTHOVISC product line, as well as increased
aesthetic dermatology product sales.
Total revenue for the fourth quarter of 2009 increased 18% to
$10,619,000 from $8,966,000 in the fourth quarter of 2008. Total revenue
for the full year of 2009 increased 12% to $40,136,000 compared with
$35,780,000 in 2008.
Product Gross Margin
Product gross margin for the fourth quarter of 2009 was 64% compared
with 66% in last year's fourth quarter. For full year 2009, product
gross margin was 63% compared with 60% in 2008. The full year 2009
increase in product gross margin was due to favorable product mix as
well as increased manufacturing activity in preparation for moving
operations to the Bedford facility.
Research and development expenses decreased to $1,319,000 in the fourth
quarter compared with $2,445,000 in the same period last year, and
increased to $8,182,000 for full year 2009 from $7,399,000 for 2008. The
year-over-year decrease in the fourth quarter was due to the completion
of the U.S. MONOVISC clinical trial in the third quarter. The full-year
2009 increase was due to higher regulatory and clinical development
expenses as a result of the MONOVISC clinical trial, the post-marketing
aesthetics dermatology study in people of color, as well as other
continuing new product development projects.
Selling, general and administrative expenses for the fourth quarter of
2009 increased to $2,843,000 from $2,450,000 for the same period last
year, and decreased to $10,545,000 for the full year 2009 from
$10,965,000 in 2008. The increase for the fourth quarter was due to
higher personnel, legal and new facility costs, while the decrease for
the full year 2009 was due to lower marketing costs as the Company had
incurred significant costs in 2008 related to the European launch of
MONOVISC and ORTHOVISC mini.
In the fourth quarter of 2009, Anika recorded $1,241,000 in expenses
related to its recent acquisition of Fidia Advanced Biopolymers, s.r.l.
("FAB"), formerly a wholly-owned subsidiary of privately held Italian
pharmaceutical company, Fidia Farmaceutici S.p.A. For full year 2009,
Anika recorded $2,152,000 in acquisition-related expenses.
Net income for the fourth quarter of 2009 was $697,000, or $0.06 per
diluted share. Net income for full year 2009 was $3,688,000, or $0.32
Excluding acquisition-related expenses, non-GAAP net income for the
fourth quarter of 2009 would have been $2,026,000, or $0.17 per diluted
share. This is an 85% increase from $1,095,000, or $0.10 per diluted
share, for the fourth quarter of 2008. Non-GAAP net income for full year
2009 would have been or $5,527,000, or $0.48 per share. This represents
a 52% increase from $3,629,000, or $0.32 per diluted share, for full
Anika's cash and cash equivalents at December 31, 2009 were $24,427,000
compared with $43,194,000 at December 31, 2008. The decrease in cash was
due primarily to the acquisition of FAB as well as capital expenditures
at Anika's Bedford facility, principal and interest payments on the
Company's debt, increase in accounts receivable, and inventory build
needed in preparation for relocating the existing manufacturing
equipment to the Bedford facility.
Management Commentary
"In a year that culminated with the transformative acquisition of Fidia
Advanced Biopolymers (FAB), Anika performed well financially and
achieved many important strategic milestones," said Charles Sherwood,
Ph.D., Anika's president and chief executive officer. "In 2009, we grew
overall revenue 12% to $40.1 million. We also completed our
seventh-consecutive profitable year, while making significant
investments in infrastructure and product development."
"Anika concluded this year of achievement with another quarter of
year-over-year top-line growth," Sherwood said. "Our joint health
franchise continued to perform in-line with our high expectations with
excellent domestic sales of ORTHOVISC. During the quarter, we completed
our PMA filing for MONOVISC, our single-injection joint health product,
with the FDA. We continue to be enthusiastic about the prospects for
this innovative product."
"Clearly, the landmark event of the quarter was our acquisition of FAB,"
Sherwood continued. "FAB provides Anika with an exciting new growth
platform and advances our vision to offer therapeutic products that go
beyond pain relief to protect and restore damaged tissue. Once approved,
we expect that FAB's joint health product portfolio along with MONOVISC
will provide our direct commercialization team with a critical mass of
products to sell into the U.S. market."
"As we look to 2010 and beyond, we are well positioned to benefit from
the significant investments we have made in our future and the
milestones we achieved during the past year," said Sherwood. "We have
six key goals for 2010: develop our direct sales model and launch
MONOVISC domestically upon its approval by the FDA; obtain approval and
launch key FAB orthopedic products in the United States; complete the
total transfer of our manufacturing operations to Bedford; expand FAB's
innovative tissue technology product beyond Italy into other areas of
Europe; continue to grow sales of ORTHOVISC and MONOVISC worldwide; and