-----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, J6YVZf/LnLb1o1y1CDgYNF2vqSspfG/6Kyn4M5DBE+J0bvOCcv1VE7DJDk/gcjKC dWFpAlmLGrrhBkamU9FVTw== 0001104659-03-008191.txt : 20030506 0001104659-03-008191.hdr.sgml : 20030506 20030506095959 ACCESSION NUMBER: 0001104659-03-008191 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20030506 ITEM INFORMATION: Financial statements and exhibits ITEM INFORMATION: Regulation FD Disclosure FILED AS OF DATE: 20030506 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: 03683282 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 j0340_8k.htm 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):  May 6, 2003

 

 

Anika Therapeutics, Inc.

(Exact Name of Registrant as Specified in Its Charter)

 

 

Massachusetts

 

000-21326

 

04-3145961

(State or Other Jurisdiction of
Incorporation or Organization)

 

(Commission file Number)

 

(I.R.S. Employer Identification No.)

 

 

 

 

 

160 New Boston Street, Woburn, Massachusetts

 

01801

(Address of Principal Executive Offices)

 

(Zip Code)

 


 

Registrant’s Telephone Number, Including Area Code: (781) 932-6616

 

 



 

ITEM 7:                            FINANCIAL STATEMTENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS.

 

(c)          Exhibits

 

Exhibit 99.1 — Press Release of Anika Therapeutics, Inc. dated May 6, 2003.

 

ITEM 9:                            REGULATION FD DISCLOSURE.

 

This Form 8-K is being furnished to report information pursuant to Item 12 - Results of Operations and Financial Conditions in accordance with the interim guidance provided by the SEC pursuant to SEC Release No. 33-8216 and 34-47583.  On May 6, 2003, Anika Therapeutics, Inc. issued a press release (“Press Release”) announcing its financial results for the first quarter of 2003.  A copy of the Press Release is attached as Exhibit 99.1 to this Current Report and is incorporated herein by reference.

 

 

2



 

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, thereunto duly authorized in Woburn, Massachusetts on May 6, 2003.

 

 

Anika Therapeutics, Inc.

 

 

 

May 6, 2003

By:

/s/  Charles H. Sherwood

 

 

Charles H. Sherwood, Ph.D.
Chief Executive Officer and President

 

 

3



 

Exhibit Index

 

Exhibit No.

 

Description

99.1

 

Press Release of Anika Therapeutics, Inc. dated May 6, 2003

 

 

4


EX-99.1 3 j0340_ex99d1.htm EX-99.1

Exhibit 99.1

 

FOR IMMEDIATE RELEASE

 

Contact:

Anika Therapeutics, Inc.
Charles Sherwood, Ph.D., CEO
William Knight, CFO
(781) 932-6616

 

Pondel/Wilkinson Klein
Susan Klein (508) 358-4315
Rob Whetstone (323) 866-6060

 

 

ANIKA THERAPEUTICS ANNOUNCES FIRST QUARTER FINANCIAL RESULTS

 

 

WOBURN, Mass. — May 6, 2003 — Anika Therapeutics, Inc. (NASDAQ:ANIK) today announced that revenue for the first quarter ending March 31, 2003 rose 42% to $3,384,000 from $2,390,000 for the same period last year.  The company reported a net loss for the quarter of $313,000, or $.03 per share, compared with a loss of $1,804,000, or $.18 per share, for the first quarter of 2002.

 

Charles H. Sherwood, Ph.D., president and chief executive officer, said higher ophthalmic product sales with the addition of a new customer in May 2002 contributed to revenue growth for the quarter.    Sales of HYVISC®, a treatment for equine osteoarthritis, were also up on a quarter-over-quarter basis, due in part to distributor inventory replenishment for certain units shipped without required regulatory approval in the latter part of 2002, as Anika previously reported.

 

Anika’s gross profit for the quarter was 42% of sales versus 13% for the first quarter of 2002, mostly reflecting increased unit volumes combined with manufacturing efficiency gains achieved during 2002.  Research and development expenses totaled approximately $809,000 versus $1,090,000 for the comparable 2002 quarter, a period of high patient accrual for Anika’s ORTHOVISC clinical trial.  Selling, general and administrative expenses were $1,115,000 compared with $1,080,000 for the same period last year. Results for the first quarter also included a non-recurring tax refund of $154,000.  Anika’s cash and short-term investments at March 31, 2003 totaled $13.0 million compared with $13.5 million at December 31, 2002 and $12.4 million at March 31, 2002.

 

“Right now we are very focused on conducting the final analyses of our ORTHOVISC Phase III human clinical trial data in preparation for filing a submission with the Food & Drug Administration for U.S. market approval,” Sherwood said.  “We also are hard at work toward adding international marketing and distribution partners for ORTHOVISC and narrowing in on a potential U.S. marketing partner.”  Sherwood noted that Anika plans to increase expenditures in 2003 on marketing its current products and on potential clinical trials for therapies in its product pipeline.

 

 



 

Conference Call Information

The company will hold a conference call to review its financial results today at 11:00 a.m. EDT.  To listen to the conference call, dial (706) 634-1550 approximately 10 minutes before the starting time and reference Anika Therapeutics.  The call can also be accessed through a live Internet broadcast at Anika’s Web site, http://www.anikatherapeutics.com/newset.htm.  The call will be archived at the same Web site beginning at 2 p.m. today for one year through May 6, 2004.

 

About Anika Therapeutics, Inc.

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 acid (HA), a naturally occurring, biocompatible polymer found throughout the body.

 

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 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,” “intend,” “our goal,” “our strategy,” “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.  These statements also include statements regarding: (i) the Company’s efforts and expectations in entering into long-term arrangements to market and distribute ophthalmic and osteoarthritis products, (ii) the level of the Company’s revenue or sales in particular geographic areas and/or for particular products, (iii) the market share of any of the Company’s products, (iv) expectations regarding future results of operations, (v) the Company’s intention to strengthen, expand and grow its ophthalmic franchise, (vi) the Company’s goal of obtaining FDA approval for ORTHOVISC®, (vii) the Company’s intention to increase market share for Orthovisc in international markets or otherwise penetrate growing markets for osteoarthritis of the knee, (viii) the Company’s intentions on continuing research and development expenditures, (ix) the Company’s ability to develop new products, including therapies in the existing product pipeline or develop any such products with meaningful sales, and (x) the Company’s corporate objectives and research and development and collaboration opportunities.  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 ability to successfully complete clinical trials of ORTHOVISC® 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 ORTHOVISC® or that such approvals will not be obtained in a timely manner or without the need for additional clinical trials; (ii) the success of the Company’s efforts to improve the financial performance of its business; (iii) the Company’s research and product development efforts and their relative success, including whether the Company has any meaningful sales of any new products resulting from such efforts;(iv) the strength of the Turkish economy in general and other economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas or (v) future determinations by the Company to allocate resources to products and in directions not presently contemplated.  Any delay in receiving any regulatory approvals may adversely affect the Company’s competitive position.  Even if regulatory approvals are obtained, there is a risk that meaningful sales of the products may not be achieved.    There is also a risk that (i) the Company’s existing distributors or customers will not continue to place orders at historical levels or that any of them will seek to modify or terminate existing arrangements, (ii) the Company’s efforts to enter into long-term marketing and distribution arrangements will not be successful, including enlisting a distribution partner for ORTHOVISC®, (iii) new distribution arrangements will not result in meaningful sales of the Company’s products, or (iv) increased sales of the Company’s products, including HYVISC®, ORTHOVISC® or its ophthalmic products will not continue or sales will decrease, any of which may have a material adverse effect on the Company’s business and operations.  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 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, 2002, and Current Reports on Form 8-K, as well as those described in the Company’s other press releases and SEC filings.

 

 

2



 

Anika Therapeutics, Inc. and Subsidiaries

Consolidated Statements of Operations

 

 

 

 

Quarter Ended
March 31,

 

 

 

2003

 

2002

 

Product revenue

 

$

3,370,000

 

$

2,385,000

 

License revenue

 

14,000

 

5,000

 

Total revenue

 

3,384,000

 

2,390,000

 

Cost of product revenue

 

1,969,000

 

2,087,000

 

Gross profit

 

1,415,000

 

303,000

 

Operating expenses:

 

 

 

 

 

Research and development

 

809,000

 

1,090,000

 

Selling, general and administrative

 

1,115,000

 

1,080,000

 

Total operating expenses

 

1,924,000

 

2,170,000

 

Loss from operations

 

(509,000

)

(1,867,000

)

Interest income, net

 

42,000

 

63,000

 

Loss before income tax benefit

 

(467,000

)

(1,804,000

)

Income tax benefit

 

154,000

 

 

Net loss

 

$

(313,000

)

$

(1,804,000

)

 

 

 

 

 

 

Basic and diluted net loss per common share

 

$

(0.03

)

$

(0.18

)

Shares used to calculate basic and diluted net loss per common share

 

9,934,280

 

9,934,280

 

 

 

3



 

Anika Therapeutics, Inc. and Subsidiaries

Consolidated Balance Sheets

 

 

 

 

March 31,
2003

 

December 31,
2002

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

10,490,000

 

$

11,002,000

 

Marketable securities

 

2,500,000

 

2,500,000

 

Accounts receivable, net

 

948,000

 

1,198,000

 

Inventories

 

3,174,000

 

2,924,000

 

Prepaid expenses and other current assets

 

245,000

 

320,000

 

Total current assets

 

17,357,000

 

17,944,000

 

Property and equipment, at cost

 

9,715,000

 

9,619,000

 

Less:  accumulated depreciation

 

(7,927,000

)

(7,679,000

)

 

 

1,788,000

 

1,940,000

 

Long-term deposits

 

143,000

 

143,000

 

Notes receivable from officers

 

59,000

 

59,000

 

Total assets

 

$

19,347,000

 

$

20,086,000

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

719,000

 

$

845,000

 

Accrued expenses and other current liabilities

 

1,548,000

 

1,703,000

 

Customer deposit

 

 

327,000

 

Deferred revenue

 

329,000

 

147,000

 

Total current liabilities

 

2,596,000

 

3,022,000

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Preferred stock, $.01 par value; 1,250,000 shares authorized, no shares issued and outstanding

 

 

 

Common stock, $.01 par value; 30,000,000 shares authorized, 9,991,943 shares issued

 

100,000

 

100,000

 

Additional paid-in capital

 

31,640,000

 

31,640,000

 

Treasury stock (at cost, 57,663 shares)

 

(280,000

)

(280,000

)

Accumulated deficit

 

(14,709,000

)

(14,396,000

)

Total stockholders’ equity

 

16,751,000

 

17,064,000

 

Total liabilities and stockholders’ equity

 

$

19,347,000

 

$

20,086,000

 

 

 

4


-----END PRIVACY-ENHANCED MESSAGE-----