Full Press Release Details
Therapeutics Announces Date of Fourth-Quarter and Year-End 2010
Financial Results Conference Call and Provides Regulatory Timing Update
Anticipated Timeline for Pending U.S. Product Approvals and Clearances
and Final FDA Approval of Bedford Manufacturing Facility
BEDFORD, Mass.--(BUSINESS WIRE)--February 14, 2011--Anika Therapeutics,
Inc. (Nasdaq: ANIK) today announced that it plans to issue its
fourth-quarter and year-end 2010 financial results after the close of
the market on Wednesday, March 9, 2011. The Company plans to hold a
conference call the next day, Thursday, March 10, at 9:00 a.m. ET to
discuss its financial results, business highlights and outlook. The
Company will also answer questions concerning business and financial
developments and trends, and other business and financial matters
affecting the Company, some of the responses to which may contain
information that has not been previously disclosed.
In addition, the Company announced a Regulatory timing update.
MONOVISC : After extended dialogue with the FDA, and
disappointment in the speed of the FDA's process, the Company recently
requested review of MONOVISC through the Orthopedic Advisory Panel. The
Company has not yet received a date for an Advisory Panel meeting, but
continues to believe that MONOVISC should receive FDA approval.
Bedford Facility Manufacturing Approval: As previously disclosed, the
Company is in the process of moving the manufacturing of its products
from its Woburn, Massachusetts, facility to its Bedford, Massachusetts,
facility. The Company received FDA approval to manufacture its
terminally sterilized product, ELEVESS , in its Bedford facility in
November 2010. The Company has certain critical equipment used to
manufacture its ophthalmic and orthopedic products which cannot be
duplicated due to timing and expense factors. The Company believed that
it had an agreement with the FDA to move that equipment, validate its
use in Bedford and then briefly return it to service in Woburn, and have
the validation data and reports reviewed as part of a final inspection
of the Bedford facility, scheduled in December 2010. That final
inspection did not occur and will not occur now until the equipment is
permanently installed in Bedford. In order to fill product orders and
build sufficient safety stock to accommodate any further approval
delays, manufacturing of the ophthalmic and orthopedic products will
continue in Woburn into June 2011. During this period, expenses will be
managed in Bedford to minimize the impact of operating duplicate
510(k) Submissions: As previously disclosed, the Company filed three
510(k) premarket notifications for Anika Therapeutics S.r.l. products in
October 2010, originally anticipating clearance by the end of 2010 for
one of the products and clearance for the other two products in the
first quarter of 2011. Although there has been delay in the FDA's review
process, the Company still believes that all of the products should
receive clearance as submitted. Given the delay, however, the Company is
unable to predict the timing of receipt of these clearances.
To listen to the financial results conference call, dial 866-202-4367
(international callers dial 617-213-8845) and use the passcode 69151063.
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 the Company's website, www.anikatherapeutics.com.
An accompanying slideshow presentation also can be accessed via the
Company's website. 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, repair and regeneration. These products are based
on hyaluronic acid (HA), a naturally occurring, biocompatible polymer
found throughout the body. Anika's products range from orthopedic/joint
health solutions led by ORTHOVISC , a treatment for osteoarthritis of
the knee; to surgical aids in the ophthalmic and anti-adhesion fields.
The Company also offers aesthetic dermal fillers for the correction of
facial wrinkles. Anika's Italian subsidiary, Anika Therapeutics S.r.l.,
provides complementary HA products in orthopedic/joint health and
anti-adhesion, as well as therapeutics in new areas such as advanced
wound treatment and ear, nose and throat care. FAB's regenerative tissue
technology advances Anika's vision to offer therapeutic products that go
beyond pain relief to protect and restore damaged tissue.
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, as amended, and Section 21E
of the Securities Exchange Act of 1934, as amended, including, without
limitation, statements that may be identified by words such as "expect,"
"remains," "focus," "prospective," "expanding," "building," "continue,"
"progress," "plan," "efforts," "hope," "believe," "objectives,"
"opportunities," "will," "seek," "anticipate" and other expressions
which are predictions of or indicate future events and trends do not
constitute historical matters and identify forward-looking statements.
These statements also include those relating to: (i) the potential
success of the Orthopedic Advisory Panel regulatory pathway we are
taking for MONOVISC and the likelihood, timing and impact of, and
requirements and reasons for, FDA approval of this product, if at all;
(ii) the timing of the reinstallation of certain critical equipment in
our Bedford, Massachusetts manufacturing facility and our expectations
regarding the amount and impact of the increased expenses associated
with operating duplicate facilities in both Woburn, Massachusetts and
Bedford, Massachusetts; (iii) the consolidation of Anika's manufacturing
operations in Bedford, Massachusetts, and our expectations regarding the
likelihood, timing and impact of, and requirements for, the FDA's
inspection and subsequent approval of this facility, if at all; (iv) the
likelihood, amount and impact of, or reasons for, any increased expenses
associated with delays in receipt of FDA approval of MONOVISC or our
Bedford, Massachusetts manufacturing facility; and (v) the likelihood,