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8-K - ANIKA THERAPEUTICS, INC. 8-K - Anika Therapeutics, Inc. | a6130392.htm |
EX-2.1 - EXHIBIT 2.1 - Anika Therapeutics, Inc. | a6130392ex2-1.htm |
EX-10.1 - EXHIBIT 10.1 - Anika Therapeutics, Inc. | a6130392ex10-1.htm |
EX-10.2 - EXHIBIT 10.2 - Anika Therapeutics, Inc. | a6130392ex10-2.htm |
EX-10.3 - EXHIBIT 10.3 - Anika Therapeutics, Inc. | a6130392ex10-3.htm |
EX-10.4 - EXHIBIT 10.4 - Anika Therapeutics, Inc. | a6130392ex10-4.htm |
Exhibit
99.1
Contact:
Anika
Therapeutics, Inc.
Charles H.
Sherwood, Ph.D., CEO
Kevin W.
Quinlan, CFO
Tel: 781-457-9000
Anika
Therapeutics Acquires Fidia Advanced Biopolymers: A Leading Innovator in
Hyaluronic Acid Based Tissue Engineered Products
Acquisition
Provides Novel Technology Platform for Growth & Broadens
Anika’s
Product
Portfolio and Development Pipeline
Company
to Develop Direct Sales Capability for MONOVISC™ and FAB Products
BEDFORD,
Mass, – December 31, 2009 – Anika Therapeutics, Inc. (Nasdaq: ANIK) today
announced that it has acquired Fidia Advanced Biopolymers, s.r.l.
(“FAB”), a wholly-owned subsidiary of privately held Italian pharmaceutical
company, Fidia Farmaceutici S.p.A. FAB provides hyaluronic acid-based
(“HA”) products in several therapeutic areas including for the regeneration of
connective and structural tissues damaged by injuries, aging or degenerative
diseases. The Company also announced that it will develop its own
direct U.S. sales capability to capture significantly higher margins from the
domestic sales of MONOVISC™, its single-injection osteoarthritis
treatment. Direct commercialization activities will also include the
portfolio of FAB orthopedic products once approvals are achieved in the United
States.
Under the
terms of the sale and purchase agreement, Anika purchased FAB in exchange for
USD $17.1 million in cash and 1,981,192 shares of its common
stock. FAB recorded product revenue of approximately USD $11.1
million in the 12 months ended September 30, 2009. Anika anticipates
that the acquisition will be accretive to earnings in the second year of
combined operations.
FAB has
approximately 50 employees at its headquarters in Abano Terme, Italy,
which includes R&D and cell culture laboratories, as well as commercial and
manufacturing operations. FAB’s unique, patented technology for
modifying HA to produce fibers, films and textile biomaterials is used in a wide
variety of medical device applications. FAB also pioneered in
Europe the development of tissue engineered products for cartilage regeneration
and treatment of burns and diabetic ulcers. FAB’s modified HA
technology is also commercialized in a range of orthopedic, otolaryngology, and
urogynecology products.
“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,” said Charles H. Sherwood, Ph.D., Anika’s President and Chief
Executive Officer. “FAB’s complementary regenerative technology
allows us to expand Anika’s commercial product portfolio and development
pipeline with innovative joint health and other therapeutic
products. FAB also has a strong research ability that complements
Anika’s excellent development and manufacturing resources.”
“FAB’s
innovative orthopedic product portfolio will provide us with a critical mass of
products to sell into the U.S. market along with MONOVISC upon its approval,”
said Sherwood. “We filed the final module of our MONOVISC PMA
containing the clinical data on December 24th, and
we expect to receive U.S. FDA approval in the second half of
2010. Internationally, we are planning to leverage FAB’s strong
distributor partners in Europe and Asia to enhance sales of MONOVISC and Anika’s
other products in new and existing international markets.”
“The
acquisition of FAB and the decision to build a direct Anika sales capability are
two important, mutually reinforcing milestones that we expect to propel Anika to
a new stage of growth. We are confident that our integrated team will
realize significant upside potential from the combined company, and we look
forward to welcoming FAB’s talented employees to Anika,” concluded
Sherwood.
Conference
Call
Anika will
conduct a special conference call on Monday, January 4, 2010 at 10 a.m. (Eastern
time) to provide an overview of the transaction and other business and
financial matters affecting the Company, some of which may contain information
that has not been previously disclosed. To listen to the conference
call, dial 800-299-7089 (International callers dial 617-801-9714) and use the
passcode 31471402. Please call approximately 10 minutes before the starting time
and reference Anika Therapeutics. In addition, the conference call will be
available to interested parties through a live audio webcast in the "Investor
Relations" section of Anika’s website, www.anikatherapeutics.com. The
call will be archived and accessible on the same website shortly after the
conclusion of the call.
The
webcast also is being distributed through the Thomson StreetEvents Network.
Individual investors can listen to the call at www.earnings.com, Thomson's
individual investor portal, powered by StreetEvents. Institutional
investors can access the call via Thomson StreetEvents (www.streetevents.com), a
password-protected event management site.
About
Anika Therapeutics, Inc.
Headquartered
in Bedford, Mass., Anika Therapeutics,
Inc. 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. Anika’s products include ORTHOVISC®, a
treatment for osteoarthritis of the knee available internationally and marketed
in the U.S. by DePuy Mitek; HYVISC®,
a treatment for equine osteoarthritis marketed in the U.S. by Boehringer
Ingelheim Vetmedica, Inc.; the ELEVESS, ELEVESS Light, and HYDRELLE family of
aesthetic dermatology products for facial wrinkles, scar remediation and lip
augmentation; AMVISC®, AMVISC® Plus, STAARVISC™-II and
Shellgel™ injectable viscoelastic HA products for ophthalmic surgery;
INCERT®,
an HA-based anti-adhesive for surgical applications; ORTHOVISC® mini
a treatment for osteoarthritis targeting small joints and available in Europe;
MONOVISC™ a
single-injection osteoarthritis product based on Anika’s proprietary
cross-linking technology and available in Europe, Turkey and Canada; and next
generation products for joint health and aesthetic dermatology based on the
Company’s proprietary, chemically modified HA.
This
press release contains, and the Company’s conference call may contain,
forward-looking statements within the meaning of the federal securities
laws. The statements made in this press release and those that may be
made during the Company’s conference call 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 “expectations,” “remains,” “focus,” “expected,” “prospective,” “expanding,”
“building,” “continue,” “progress,” “plan,” “efforts,” “hope,” “believe,”
“objectives,” “opportunities,” “will,” “seek,” “expect” and other expressions
which are predictions of or indicate future events and trends and which do not
constitute historical matters identify forward-looking
statements. These statements also include: (i) expectations about the
Company’s development of its own direct U.S. sales capability to capture
significantly higher margins from the domestic sales of MONOVISC and FAB
products; (ii) expectations that the acquisition of FAB will be accretive to the
Company’s earnings, realize significant upside potential, and propel the Company
to a new stage of growth; (iii) expectations that the FAB acquisition will
provide the Company with new growth platforms and advances, including expanding
the Company’s commercial product portfolio and development pipeline and
providing a critical mass of products to sell into the U.S. market as well as
leveraging FAB’s distributor partners in Europe and Asia to enhance sales of
MONOVISC and other products in new and existing international markets; (iv) the
Company’s expectations concerning its MONOVISC product, including the U.S.
clinical trials and receiving Food and Drug Administration (“FDA”) approval of
the MONOVISC PMA filing in 2010;and (v) the Company’s ability to capitalize on
exciting growth opportunities and fulfill its joint health vision to alleviate
pain, repair and restore damaged tissue. These statements are based
upon the current beliefs and expectations of the Company’s 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: (i) the Company’s future sales and
product revenues, including geographic expansions, possible retroactive price
adjustments, and expectations of unit volumes or other offsets to price
reductions; (ii) the Company’s manufacturing capacity and efficiency gains and
work-in-process manufacturing operations; (iii) the timing, scope and rate of
patient enrollment for clinical trials; (iv) the development of possible new
products; (v) the Company’s ability to achieve or maintain compliance with laws
and regulations; (vi) the timing of and/or receipt of the FDA, foreign or other
regulatory approvals and/or reimbursement approvals of current, new or potential
products, and any limitations on such approvals; (vii) negotiations with
potential and existing partners, including the Company’s performance under any
of the Company’s existing and future distribution or supply
agreements or the Company’s expectations with respect to sales and sales
threshold milestones pursuant to such agreements; (viii) the level of the
Company’s revenue or sales in particular geographic areas and/or for particular
products, and the market share for any of the Company’s products; (ix) the
Company’s current strategy, including the Company’s corporate objectives and
research and development and collaboration opportunities; (x) the Company’s and
Bausch & Lomb’s performance under the existing supply agreement for certain
of the ophthalmic viscoelastic products, the Company’s ability to remain the
exclusive global supplier for AMVISC and AMVISC Plus to Bausch & Lomb, and
the Company’s expectations regarding revenue from ophthalmic products; (xi) the
Company’s ability, and its distribution partner’s ability, to market its
aesthetic dermatology product; (xii) the Company’s intention to increase market
share for joint health products in international and domestic markets or
otherwise penetrate growing markets for osteoarthritis of the knee and other
joints; (xiv) the Company’s ability to license its aesthetics product to new
distribution partners outside of the United States; (xiii) the rate at which the
Company uses cash, the amounts used and generated by operations, and
expectations regarding the adequacy of such cash; (xv) possible negotiations or
re-negotiations with existing or new distribution or collaboration partners;
(xvi) expectations regarding the Company’s existing manufacturing facility and
the Bedford, MA facility, the Company’s expectations related to costs, including
financing costs, to build-out and occupy the new facility, and the Company’s
ability to obtain FDA licensure for the facility; (xvii) the Company’s ability
to comply with debt covenants and obtain additional funds through equity or debt
financings, strategic alliances with corporate partners and other sources, to
the extent the Company’s current sources of funds are insufficient; (xviii) the
Company’s plans to address the FDA’s Warning Letter and Form 483 Notice of
Observations and the impact any associated regulatory action would have on its
business and operations; and (xix) the Company’s expectations regarding its
joint health products, including expectations regarding new products, expanded
uses of existing products, new distribution and revenue growth, next generation
osteoarthritis/joint health product developments, clinical trials, regulatory
approvals, and commercial launches, HYVISC sales, the development and
commercialization of INCERT, and the market potential for INCERT, HYDRELLE
product sales in the U.S., product gross margin, next generation
osteoarthritis/joint health product developments, clinical trials, regulatory
approvals, and commercial launches, commencement of clinical trial for CINGAL
and ability to obtain regulatory approvals for CINGAL, existing aesthetics
product’s line extensions, increases in operating expenses, including research
and development and selling, general and administrative expenses, capital
expenditures spending and decline in interest income, 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 the Company’s Annual Report on
Form 10-K for the year ended December 31, 2008 and on Form 10-Q for the period
ended September 30, 2009, as well as those described in the Company’s other
press releases and SEC filings. The Company’s results may also be
affected by factors of which the Company is not currently aware. The Company may
not update these forward-looking statements, even though its situation may
change in the future, unless it has obligations under the federal securities
laws to update and disclose material developments related to previously
disclosed information.