Anika Therapeutics develops, manufactures and
commercializes therapeutic products for tissue
protection, healing and repair. These products are
based on hyaluronic acid (HA), a naturally occurring,
biocompatible polymer found throughout the body.
HA enhances joint function and coats, protects,
cushions and lubricates soft tissues. HA is also present
in the skin, supporting skin structure and elasticity.
Anika’s commercial product franchises address the
joint health, aesthetic dermatology, ophthalmic,
veterinary and anti-adhesion markets.
ƒ Market trends driving growth potential
ƒ Strong international and domestic demand for ORTHOVISC®
ƒ Technological leadership and robust product pipeline for
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joint health markets worldwide
Launched MONOVISC®, a single-injection osteoarthritis
product, in Europe; also completed enrollment for a U.S.
clinical study
Launched ORTHOVISC® mini in Europe for the treatment of
smaller joints
ELEVESS™ aesthetic dermatology product provides new
growth opportunities
Investments in new facility and new product development
are expected to accelerate future growth
®
ORTHOVISC is an FDA-approved
non-drug therapy that provides
lubrication for the knee and helps
cushion the knee joint.
®
ORTHOVISC relieves knee pain
for up to six months without
drugs or surgery in patients who
do not get relief from simple pain
relievers and physical
®
therapy/exercise. MONOVISC , a
single-injection extension
product, was launched in Europe
in 2008.
ELEVESS™ is Anika’s first crosslinked
HA-based injectable dermal filler.
The formulation of the product
alleviates injection pain with the
addition of the anesthetic
lidocaine. ELEVESS is approved by
the FDA for use in correcting
nasolabial folds (smile lines). Anika
plans to broaden its portfolio of HA
fillers for other indications, such as
fine lines, deep folds and lips.
Price:
52-Week High:
52-Week Low:
Shares Outstanding:
Market Cap:
Trailing P/E:
Fiscal Year End:
$5.65
$10.65
$2.96
11.4 million
$63.8 million
17.66
Dec. 31
In order to build on Anika’s momentum, the Company’s
strategy for 2009 includes plans to:
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Significantly grow U.S. and international ORTHOVISC
sales
Grow sales of MONOVISC and ORTHOVISC mini
Complete MONOVISC pivotal clinical trial in the
United States and file for marketing approval
Continue to broaden its worldwide joint health
franchise with new and differentiated products
Expand distribution for aesthetics franchise
Begin manufacturing at new state-of-the-art Bedford
facility
Submit CE Mark application for Cingal, Anika’s new
single injection joint health product with an active
therapeutic molecule for pain relief
Amvisc™, Amvisc™ Plus and
STAARVISC™, Anika’s viscoelastic
solutions are used in most
ophthalmic intraocular surgeries
including cataract extraction, IOL
insertion and removal, corneal
surgery, glaucoma surgery, trauma
surgery, posterior segment surgery,
ocular plastic surgery and muscle
surgery.
®
HYVISC is a highly viscous,
extremely pure injectable
formulation of sodium
hyaluronate for the treatment
of joint dysfunction in horses
associated with equine
osteoarthritis. Equine
practitioners select HYVISC
because of its ease of use,
efficacy, purity and economy.
($ in thousands)
Product Lines
$3 3 ,0 55
$3 5,0 0 0
Research
Clinical Development Regulatory
Preclinical
Approval
Development
Pilot
Pivotal
Joint Health
Market
Received Unique Reimbursement
Code & New International Agreements
ORTHOVISC
MONOVISC
$2 6 , 9 0 5
$3 0 ,0 0 0
$2 2 ,2 8 6
$2 5,0 0 0
$2 0 ,0 0 0
CE Mark
CINGAL
$2 3 ,9 53
Received U.S., Canadian
and European Approval
Aesthetics
$2 0 ,53 4
ELEVESS
$15,3 3 0
Next Generation
$15,0 0 0
Veterinary
HYVISC
$10 ,0 0 0
$5,0 0 0
Anti-Adhesion
INCERT
$0
2003
2004
2005
2006
2007
CE Mark
2008
Drug Delivery
(in millions except for EPS and Gross Margin)
2005
2006
2007
2008
Product Revenue
$20.5
$24.0
$26.9
Total Revenue
$29.8
$26.8
$30.8
Product Gross Margin
46%
54%
Net Income
$5.9
Diluted EPS
$0.52
Q1’08
Q1’09
$33.1
$7.9
$8.5
$35.8
$8.5
$9.2
56%
60%
59%
62%
$4.6
$6.0
$3.6
$0.6
$0.5
$0.41
$0.53
$0.32
$0.05
$0.05
Corporate Headquarters
Anika Therapeutics, Inc.
32 Wiggins Avenue • Bedford, MA 01730
Tel: (781) 457-9000
Email: [email protected]
Corporate Officers
Charles H. Sherwood, Ph.D.
President and Chief Executive Officer
Kevin W. Quinlan
Chief Financial Officer
Andrew J. Carter, Ph. D.
Chief Technology Officer
Irina B. Kulinets
Vice President, Regulatory and Clinical Affairs
Safe Harbor Statement
This fact sheet contains "forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. Such forward-looking statements include
without limitation, statements that may be identified by words such as "expectations,"
"remains," "focus," "expected," "prospective," "expanding," "building," "continue,"
"progress," "efforts," "hope," "believe," "objectives," "opportunities," "will," "seek," and
other expressions which are predictions of or indicate future events and trends and which
do not constitute historical matters identify forward-looking statements. The statements
are based upon the current beliefs and expectations of management and are subject to
significant risks, uncertainties and other factors. 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 Company's ability to successfully commence and/or complete clinical trials of its
products on a timely basis or at all, obtain clinical data to support a pre-market approval
application and/or FDA approval, and/or receive FDA or other regulatory approvals of its
products, or that such approvals will not be obtained in a timely manner or without the
need for additional clinical trials; and the results of its research and product
development efforts and their relative success and timing of regulatory approvals; and
commercialization of the Company's products. 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
"Management's Discussion and Analysis of Financial Condition and Results of Operations"
in each of the Company's Annual Report on Form 10-K for the year ended December 31,
2008.
William J. Mrachek
Vice President, Human Resources
Randall W. Wilhoite
Vice President, Operations
Investor Contact
Kevin Quinlan
Chief Financial Officer
Anika Therapeutics
Tel: (781) 457-9000
Email: [email protected]
Website: www.anikatherapeutics.com