Anika Therapeutics Announces Date of Fourth-Quarter and Year-End 2010 Financial Results Conference Call and Provides Regulatory Timing Update
Revises Anticipated Timeline for Pending U.S. Product Approvals and Clearances and Final FDA Approval of Bedford Manufacturing Facility
BEDFORD, Mass.--(BUSINESS WIRE)-- 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, ELEVESSTM, 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 facilities.
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.