-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, FQacESslDxu3et0/KD8z/wxnBrOCytVHYQyEpnTJtTZuvQrcKhQl8ftZIeGvD3La UpBy5h0epbuY5UvFZzhWAQ== 0001047469-03-003260.txt : 20030130 0001047469-03-003260.hdr.sgml : 20030130 20030130124005 ACCESSION NUMBER: 0001047469-03-003260 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20030128 ITEM INFORMATION: Financial statements and exhibits ITEM INFORMATION: FILED AS OF DATE: 20030130 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ANIKA THERAPEUTICS INC CENTRAL INDEX KEY: 0000898437 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 043145961 STATE OF INCORPORATION: MA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-14027 FILM NUMBER: 03531430 BUSINESS ADDRESS: STREET 1: 236 WEST CUMMINGS PARK CITY: WOBURN STATE: MA ZIP: 01801 BUSINESS PHONE: 6179326616 MAIL ADDRESS: STREET 1: 236 WEST CUMMINGS PARK CITY: WOBURN STATE: MA ZIP: 01801 FORMER COMPANY: FORMER CONFORMED NAME: ANIKA RESEARCH INC DATE OF NAME CHANGE: 19930309 8-K 1 a2102031z8-k.txt FORM 8-K SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ------------------------------- FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 ---------------------------------- Date of Report (DATE OF EARLIEST EVENT REPORTED): JANUARY 28, 2003 ANIKA THERAPEUTICS, INC. - -------------------------------------------------------------------------------- (EXACT NAME OF REGISTRANT AS SPECIFIED IN CHARTER) MASSACHUSETTS 000-21326 04-3145961 - ------------------------------- ----------------------- ---------------------- (STATE OR OTHER JURISDICTION (COMMISSION FILE (IRS EMPLOYER OF INCORPORATION) NUMBER) IDENTIFICATION NO.) 160 NEW BOSTON STREET, WOBURN, MASSACHUSETTS 01801 - -------------------------------------------------------------------------------- (ADDRESS OF PRINCIPAL EXECUTIVE OFFICES) (ZIP CODE) (781) 932-6616 - -------------------------------------------------------------------------------- (REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE) ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS. (c) EXHIBITS Exhibit 99.1--Press Release of Anika Therapeutics, Inc. dated January 28, 2003 ITEM 9. REGULATION FD DISCLOSURE. On January 28, 2003 Anika Therapeutics, Inc. issued the press release attached hereto as Exhibit 99.1 and incorporated herein in its entirety. SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. ANIKA THERAPEUTICS, INC. Date: January 30, 2003 /s/ CHARLES H. SHERWOOD -------------------------------------- Charles H. Sherwood Chief Executive Officer and President EXHIBIT INDEX EXHIBIT NO. DESCRIPTION - ----------- ----------- 99.1 Press Release of Anika Therapeutics, Inc. dated January 28, 2003 EX-99.1 3 a2102031zex-99_1.txt EXHIBIT 99.1 Exhibit 99.1 FOR IMMEDIATE RELEASE Contact: ANIKA THERAPEUTICS, INC. PONDEL/WILKINSON KLEIN Charles Sherwood, Ph.D., CEO Susan Klein (508) 358-4315 William Knight, CFO Rob Whetstone (323) 866-6060 (781) 932-6616 ANIKA THERAPEUTICS ANNOUNCES RESTATEMENT OF FINANCIAL RESULTS FOR THREE- AND NINE-MONTH PERIODS ENDED SEPT. 30, 2002 WOBURN, Mass.--January 28, 2003. Anika Therapeutics, Inc. (NASDAQ: ANIK) today announced a restatement of previously-reported results for the three- and nine-month periods ended September 30, 2002. This restatement involves revenue recognized for the sale in the third quarter of 2002 of certain units of Anika's product used in the treatment of equine osteoarthritis, HYVISC(R). A new "clean room" at Anika's facility that does not have a required regulatory approval for the manufacture of HYVISC(R) from the Food and Drug Administration ("FDA") was used in the production of these units. Because the product was shipped in the absence of this regulatory approval, Anika has determined and its independent public accountants have concurred that revenue from that sale should not have been recognized. The Company has obtained all required regulatory approvals for the use of the new clean room in the manufacture of the Company's products designed for human use: ORTHOVISC(R) (not approved for sale in the U.S.), AMVISC(R), AMVISC(R) Plus, STAARVISC(TM)-II, Shellgel(TM), and CoEase(TM). Until the required regulatory approval of the new clean room is received from the FDA, Anika is using the clean room previously used in the production of HYVISC(R), which has the required regulatory approval. As a result of the restatement, the revenue for the three months ended September 30, 2002 is reduced by $326,000 to $2,906,000. The net loss for that period increased by $170,000, or $0.02 per -more- Anika Therapeutics, Inc. 2-2-2 share, to a net loss of $907,000 or $.09 per share. The revenue for the nine months ended September 30, 2002 is reduced by $326,000 to $8,716,000. The net loss increased for that period by $170,000, or $0.02 per share, to a net loss of $3,869,000 or $.39 per share. The Company's inventory at September 30, 2002 has been increased by the cost of the affected units. A summary of restated consolidated results is included with this press release. The Company has initiated discussions with the Food and Drug Administration ("FDA") regarding the shipment of HYVISC(R) described above. There can be no assurance that the FDA will respond to the Company's efforts cooperatively or will not bring regulatory or other actions or proceedings against the Company. Additionally, in the past, some companies (including Anika) that have restated their financial information have been subject to inquiry or investigation by the Securities and Exchange Commission (SEC), and to private securities litigation. Any inquiry, investigation, action or proceeding by a governmental agency or any private securities litigation could have a material adverse effect on the Company's business, financial conditions or results of operations. There is a risk that any such inquiry, investigation, action, proceeding or litigation could result in substantial costs and divert management attention and resources from the Company's business. The Company cautions that as a result of the restatement of the HYVISC(R)sale described above, the financial statements and related financial disclosures set forth in its Form 10-Q for the quarter ended September 30, 2002, filed with the United States Securities and Exchange Commission, should not be relied upon. 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 Anika Therapeutics, Inc. 3-3-3 acid (HA), a naturally occurring, biocompatible polymer found throughout the body. In addition to HYVISC(R), Anika markets and manufactures ORTHOVISC(R), a treatment for osteoarthritis of the knee (not approved for sale in the U.S.), and AMVISC(R) and AMVISC(R) Plus, which are HA viscoelastic products for ophthalmic surgery, for Bausch & Lomb. It also produces STAARVISC(TM)-II for distribution by STAAR Surgical Company, Shellgel(TM) for Cytosol Ophthalmics, Inc., and CoEase(TM) for Advanced Medical Optics, Inc. 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 EXCHANGE ACT OF 1933 AND SECTION 21E OF THE SECURITIES EXCHANGE ACT OF 1934. FORWARD-LOOKING STATEMENTS INVOLVE KNOWN AND UNKNOWN RISKS, UNCERTAINTIES AND OTHER FACTORS. THE WORDS "HOPE," "BELIEVE" 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 COMPANY'S ACTUAL RESULTS COULD DIFFER MATERIALLY FROM ANY ANTICIPATED FUTURE RESULTS, PERFORMANCE OR ACHIEVEMENTS DESCRIBED IN ANY FORWARD-LOOKING STATEMENTS AS A RESULT OF A NUMBER OF FACTORS, INCLUDING THE FOLLOWING, AMONG OTHERS. IN PARTICULAR, THERE CAN BE NO ASSURANCE THAT THE COMPANY WILL OBTAIN REGULATORY APPROVAL TO USE ITS NEW CLEAN ROOM FOR THE PRODUCTION OF HYVISC(R); THAT THE FDA, THE SEC OR OTHER GOVERNMENTAL AGENCIES WILL NOT BRING AN INQUIRY, INVESTIGATION OR REGULATORY OR OTHER ACTION OR PROCEEDING AGAINST THE COMPANY; OR THAT THE COMPANY WILL NOT BE NAMED IN A PRIVATE SECURITIES LAWSUIT. ADDITIONAL 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 EACH OF THE COMPANY'S ANNUAL REPORT ON FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 2001, ITS QUARTERLY REPORT ON FORM 10-Q FOR THE QUARTER ENDED SEPTEMBER 30, 2002 AND CURRENT REPORTS ON FORM 8-K, AS Anika Therapeutics, Inc. 4-4-4 WELL AS THOSE DESCRIBED IN THE COMPANY'S OTHER PRESS RELEASES AND FILINGS WITH THE SECURITIES AND EXCHANGE COMMISSION. # # # Anika Therapeutics, Inc. 5-5-5 ANIKA THERAPEUTICS, INC. AND SUBSIDIARIES SUMMARY OF RESTATED CONSOLIDATED RESULTS (UNAUDITED)
CONSOLIDATED STATEMENT OF OPERATIONS DATA: AS REPORTED RESTATED CHANGE -------------- -------------- -------------- QUARTER ENDED SEPTEMBER 30, 2002 Revenue $ 3,232,108 $ 2,905,628 $ (326,480) Cost of product revenue 2,131,517 1,974,807 (156,710) -------------- -------------- -------------- Gross profit 1,100,591 930,821 (169,770) -------------- -------------- -------------- Net loss $ (737,643) $ (907,413) $ (169,770) ============== ============== ============== Basic and diluted net loss per common share $ (0.07) $ (0.09) $ (0.02) ============== ============== ============== Shares used to calculate basic and diluted net loss per common share 9,934,280 9,934,280 -- ============== ============== ============== NINE MONTHS ENDED SEPTEMBER 30, 2002 Revenue $ 9,042,702 $ 8,716,222 $ (326,480) Cost of product revenue 6,420,249 6,263,539 (156,710) -------------- -------------- -------------- Gross profit 2,622,453 2,452,683 (169,770) -------------- -------------- -------------- Net loss $ (3,699,046) $ (3,868,816) $ (169,770) ============== ============== ============== Basic and diluted net loss per common share $ (0.37) $ (0.39) $ (0.02) ============== ============== ============== Shares used to calculate basic and diluted net loss per common share 9,934,280 9,934,280 -- ============== ============== ==============
CONSOLIDATED BALANCE SHEET DATA: AS REPORTED RESTATED CHANGE -------------- -------------- -------------- SEPTEMBER 30, 2002 Accounts receivable, net $ 2,303,018 $ 1,976,538 $ (326,480) Inventories 2,776,264 2,932,974 156,710 Total assets 19,927,638 19,757,868 (169,770) Total stockholders' equity 16,404,766 16,234,996 (169,770)
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