| April
29, 2004
FOR IMMEDIATE RELEASE
Anika Therapeutics Posts Profitable
2004 First Quarter; Reports 81% Revenue
Increase to $6.1 Million
WOBURN, Mass.--(BUSINESS WIRE)--April
29, 2004--Anika Therapeutics, Inc.
(Nasdaq:ANIK) today reported net earnings
for the first quarter ended March
31, 2004 of $7.8 million, or $.69
per diluted share, compared with a
net loss of $313,000, or $.03 per
diluted share, for the first quarter
of 2003. Net earnings from operations
increased $1.7 million to $1.2 million,
or $.11 per diluted share, for the
first quarter compared to a net loss
from operations of $509,000, or $.05
per diluted share, for the first quarter
of 2003. Included in net earnings
for the first quarter 2004 is a one-time
tax benefit of $7.0 million, or $.62
per diluted share.
Total revenue for the first quarter
increased 81% to $6.1 million from
$3.4 million in the comparable period
last year. Product revenue of $5.6
million for the first quarter grew
65% compared to $3.4 million in the
same period last year. Product revenue
included sales of OrthoVisc(R) to
Ortho Biotech Products, L.P., the
company's new U.S. distributor, and
royalty payments tied to U.S. OrthoVisc
end-user sales. Licensing and milestone
revenue during the quarter included
$550,000 attributable to the amortization
of previously disclosed upfront and
milestone payments received in connection
with the licensing and supply agreement
with Ortho Biotech.
"OrthoVisc sales continued to
experience significant momentum in
international markets, with Turkey
and Canada showing the strongest growth
this quarter," said Charles H.
Sherwood, Ph.D., president and chief
executive officer. "In addition
to new sales to our distributor in
Greece, our launch in Germany, Europe's
largest market, is gaining momentum
and our distributor in that country
is doing a good job building market
share.
"In the U.S., we marked a major
milestone with the launch of OrthoVisc
by Johnson & Johnson's Ortho Biotech
unit at the annual meeting of the
American Academy of Orthopaedic Surgeons
held in early March. Their U.S. sales
force is energized and, while it clearly
is too early to assess the success
of the launch, we are extremely enthusiastic
about the reception the product has
received thus far and the marketing
efforts our new distribution partner
is putting behind the product,"
Sherwood said.
Sales of the company's ophthalmic
products, which constituted 43% of
product sales for the quarter, grew
approximately 20% compared to the
first quarter of 2003. Sales of Hyvisc(R),
the company's product for equine osteoarthritis,
were up 6% for the quarter and contributed
16% of product sales for the period.
Gross margin on product revenue for
the 2004 first quarter was 51% compared
with 42% for the same period last
year. The improvement in gross margin
reflects the revenue mix and manufacturing
efficiency gains achieved throughout
2003.
Total operating expenses for the
first quarter 2004 increased 15% from
the first quarter 2003, reflecting
slightly higher clinical development
costs and general and administrative
expenses. The company noted that research
and development costs for the current
year are expected to continue to exceed
those for corresponding periods in
2003 as the company adds additional
resources to its research and development
programs and advances several product
candidates through clinical studies.
"We have treated our first patient
in a pilot study to evaluate INCERT(R).
our product for preventing post-surgical
adhesions, and we are finalizing the
protocol and preparing to start a
pivotal study for our cosmetic tissue
augmentation (CTA) product candidate,"
said Sherwood. "The pilot study
for INCERT is being conducted at two
centers in the U.K. and will encompass
approximately 45 patients. For CTA,
we will conduct a pivotal study in
the U.S. and anticipate beginning
patient treatments during the second
quarter." Sherwood added that
the company is actively pursuing discussions
with potential partners for its CTA
program.
The company has determined that it
will likely utilize all of its net
operating loss and credit carry-forwards
as a result of the receipt of the
upfront and milestone payments from
Ortho Biotech. In addition, based
on management's current expectations
regarding future profitability, the
company has released the valuation
allowance previously established against
its deferred tax assets and recorded
a one-time benefit of $7.0 million.
The company also recorded a provision
for taxes of $504,000 related to its
first quarter income. The effective
tax rate for the current provision
for the quarter was approximately
40%; the company anticipates a similar
rate for the balance of the year.
Anika's cash and cash equivalents
at March 31, 2004, totaled $34.5 million,
reflecting the $20.0 million milestone
payment from Ortho Biotech tied to
U.S. Food and Drug Administration
marketing approval for OrthoVisc in
February 2004.
About Anika Therapeutics
Headquartered in Woburn, Mass., Anika Therapeutics,
Inc. (www.anikatherapeutics.com)
develops, manufactures and commercializes therapeutic
products and devices intended to promote the repair,
protection and healing of bone, cartilage and soft tissue.
These products are based on hyaluronic acid (HA), a
naturally occurring, biocompatible polymer found throughout
the body's joints. In addition to ORTHOVISC®, Anika
markets HYVISC® in the U.S. for the treatment of
equine osteoarthritis through Boehringer Ingelheim Vetmedica,
Inc. and manufactures AMVISC® and AMVISC® Plus,
HA viscoelastic products for ophthalmic surgery, for
Bausch & Lomb. It also produces STAARVISCTM-II for
distribution by STAAR Surgical Company and ShellgelTM
for Cytosol Ophthalmics, Inc.
Contact:
Anika Therapeutics, Inc.
(781) 932-6616
Pondel Parsons & Wilkinson
Susan Klein, (508) 358-4315
Robert Whetstone, (310) 207-9300
The statements made in this press
release which are not statements of historical fact
are forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934, including,
without limitation, statements that may be identified
by words such as "designed," "believe,"
"will," "expect," "look forward,"
"expand" and other expressions which are predictions
of or indicate future events and trends and which do
not constitute historical matters identify forward-looking
statements, including without limitation statements
regarding the Company's expectations and beliefs with
respect to growth in Canadian sales of ORTHOVISC or
the Canadian osteoarthritis market or Rivex's ability
to market and distribute ORTHOVISC. These statements
are based upon the current beliefs and expectations
of the Company's management and are subject to significant
risks and uncertainties. The Company's actual results
could differ materially from any anticipated future
results, performance or achievements described in the
forward-looking statements as a result of a number of
factors including the risk that (i) Rivex's aggressive
marketing efforts do not result in meaningful sales
in Canada, (ii) enactment of adverse government regulation,
(iii) competitive pressures among hyaluronic acid viscoelastic
products may increase significantly and have an effect
on pricing, or (iv) the strength of the Canadian economy.
Certain other factors that might cause the Company's
actual results to differ materially from those in the
forward-looking statements include those set forth under
the headings "Business," "Risk Factors
and Certain Factors Affecting Future Operating Results"
and "Management's Discussion and Analysis of Financial
Condition and Results of Operations" in the Company's
Annual Report on Form 10-K for the year ended December
31, 2001, as well as those described in the Company's
other press releases and SEC filings.
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