-----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, JGRPchefy8+5lwwiTZsoZR1dg8odnIyh/UfN6NUpoubpNJpBvhY12hTYTnjTJNlm UfkAerxQUaQ32d2Q6+5BGw== 0001104659-03-016151.txt : 20030730 0001104659-03-016151.hdr.sgml : 20030730 20030730162647 ACCESSION NUMBER: 0001104659-03-016151 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20030730 ITEM INFORMATION: Financial statements and exhibits ITEM INFORMATION: Regulation FD Disclosure FILED AS OF DATE: 20030730 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: 03811779 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 a03-1603_18k.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):  July 30, 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 July 30, 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 July 30, 2003, Anika Therapeutics, Inc. issued a press release (“Press Release”) announcing its financial results for the second 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 July 30, 2003.

 

 

ANIKA THERAPEUTICS, INC.

 

 

July 30, 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 July 30, 2003

 

4


EX-99.1 3 a03-1603_1ex991.htm EX-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) 866-600

(781) 932-6616

 

 

 

ANIKA THERAPEUTICS ANNOUNCES FINANCIAL RESULTS FOR
2003 SECOND QUARTER

 

WOBURN, Mass. — July 30, 2003 — Anika Therapeutics, Inc. (NASDAQ:ANIK) today announced financial results for the second quarter and six-month period ended June 30, 2003.

 

For the second quarter, Anika posted revenues of $3,318,000, compared with $3,421,000 for the same period last year.  Net loss for the quarter was reduced to $81,000, or $.01 per share, compared with a net loss of $1,157,000, or $.12 per share, for the second quarter of 2002.

 

Revenue for the six-month period ended June 30, 2003, increased 15% to $6,702,000 versus $5,811,000 in the comparable period last year.  The net loss was $394,000, or $.04 per share, for the first six months of 2003, compared with $2,961,000, or $.30 per share, in the first six months of 2002.

 

“Revenue was impacted during the most recent quarter due to a drop in sales of HYVISC®, our treatment for equine osteoarthritis.  Sales of this product to our distributors were up in the first quarter of 2003 and on a year-to-date basis over the same periods of 2002, reflecting an inventory replenishment for certain units shipped without required regulatory approval in the latter part of 2002, as we previously reported,” said Charles H. Sherwood, Ph.D., president and chief executive officer.  “Sales of our human osteoarthritis product, ORTHOVISC®, grew 13% in overseas markets and ophthalmic sales to our distributors held steady at levels yielding 4% growth.  These results, combined with our ongoing program to improve our manufacturing operations and reduce cost of sales, and lower research and development and other corporate expenses, translated to a significantly narrowed net loss for the second quarter as compared to the second quarter of 2002.

 

“We also achieved a significant milestone this quarter with the submission of the pre-market approval application to the U.S. Food and Drug Administration for ORTHOVISC for the treatment of osteoarthritis of the knee,” Sherwood said.  “With that review under way, management is now focused on evaluating potential distribution partners for the commercialization of ORTHOVISC in the U.S. assuming FDA marketing clearance.”

 

 



 

 

Gross margins for the second quarter ended June 30, 2003 rose to 44.4% from 35.7% in the same period last year, primarily underscoring the benefit of manufacturing efficiencies the company implemented last year.  Similarly, gross margins for the six-month period increased to 43.1% from 26.2% as reported in the same period last year.

 

Research and development expenses declined 38% to $648,000 versus $1,050,000 for the second quarter of 2002.  For the six-month period, research and development expenses decreased 32% to $1,457,000 compared with $2,140,000 in the comparable period last year.  The decrease in these costs in the three and six-month periods was due primarily to the completion of the Phase III pivotal clinical study of ORTHOVISC in late 2002.

 

Selling, general and administrative expenses for the quarter ended June 30, 2003 declined 32% to approximately $945,000 versus $1,388,000 in the comparable period last year.  For the six-months ended June 30, 2003, selling, general and administrative expenses amounted to $2,060,000, as compared with $2,468,000 for the first six months of 2002.

 

Cash and short-term investments at June 30, 2003 totaled $11.5 million compared with $13.0 million at March 31, 2003.

 

Conference Call Information

 

The company will hold a conference call to review its financial results Thursday, July 31, 2003 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.  In addition, the conference call will be available to interested parties through a live audio Internet broadcast at htth://www.anikatherapeutics.com/newset.htm.  The call will be archived and accessible on the same Web site for one year beginning at 2:00 p.m. EDT Thursday, July 31, 2003.

 

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.  In addition to ORTHOVISC®, a treatment for osteoarthritis of the knee (not approved for sale in the U.S.), Anika markets HYVISC® in the U.S. for the treatment of equine osteoarthritis through Boehringer Ingelheim Vetmedica, Inc. and manufactures AMVISC® and AMVISC® Plus, HA viscoelastic products for ophthalmic surgery, for Bausch & Lomb.  It also produces STAARVISCTM-II for distribution by STAAR Surgical Company and ShellgelTM for Cytosol Ophthalmics, 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 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,” “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, including the Company’s expectations regarding cash utilization, (v) the Company’s intention to strengthen, expand and grow its ophthalmic franchise and the growth of the Company's ophthalmic business, (vi) the Company’s goal of obtaining FDA approval for ORTHOVISCÒ, (vii) the Company’s expectations of the size of the United States market for osteoarthritis of the knee, (viii) the Company’s intention to increase market share for ORTHOVISCÒ in international (and, eventually, domestic) markets or otherwise penetrate growing markets for osteoarthritis of the knee, (ix) the Company's expectations for inventory returns, and (x) the Company’s corporate objectives and research and development and collaboration opportunities, including, without limitation, intended commencement of INCERTÒ clinical trials .  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 commence and/or complete clinical trials of its products 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 its products, including ORTHOVISCÒ,  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 core 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 cost effectiveness and efficiency of our manufacturing operations and production planning; (v) 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 (vi) 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 domestic distribution partner for ORTHOVISCÒ, (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 HYVISCÒ or its ophthalmic products will not continue or sales will decrease or not reach historical sales levels, 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, its Quarterly Report on Form 10-Q for the quarter ended March 31, 2003 and Current Reports on Form 8-K, as well as those described in the Company’s other press releases and SEC filings.

 

#  #

 

 



 

 

Anika Therapeutics, Inc. and Subsidiaries
Consolidated Statements of Operations
(Unaudited)

 

 

 

Three Months Ended
June 30,

 

Six Months Ended
June 30,

 

 

 

2003

 

2002

 

2003

 

2002

 

Product revenue

 

$

3,303,000

 

$

3,416,000

 

$

6,673,000

 

$

5,801,000

 

License revenue

 

15,000

 

5,000

 

29,000

 

10,000

 

Total revenue

 

3,318,000

 

3,421,000

 

6,702,000

 

5,811,000

 

Cost of product revenue

 

1,846,000

 

2,202,000

 

3,815,000

 

4,289,000

 

Gross profit

 

1,472,000

 

1,219,000

 

2,887,000

 

1,522,000

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

648,000

 

1,050,000

 

1,457,000

 

2,140,000

 

Selling, general and administrative

 

945,000

 

1,388,000

 

2,060,000

 

2,468,000

 

Total operating expenses

 

1,593,000

 

2,438,000

 

3,517,000

 

4,608,000

 

Loss from operations

 

(121,000

)

(1,219,000

)

(630,000

)

(3,086,000

)

Interest income, net

 

40,000

 

62,000

 

82,000

 

125,000

 

Loss before income tax benefit

 

(81,000

)

(1,157,000

)

(548,000

)

(2,961,000

)

Income tax benefit

 

 

 

154,000

 

 

Net loss

 

$

(81,000

)

$

(1,157,000

)

$

(394,000

)

$

(2,961,000

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per common share

 

$

(0.01

)

$

(0.12

)

$

(0.04

)

$

(0.30

)

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

 

9,941,121

 

9,934,280

 

9,937,719

 

9,934,280

 

 

 



 

 

Anika Therapeutics, Inc. and Subsidiaries
Consolidated Balance Sheets

 

 

 

June 30, 2003

 

December 31, 2002

 

ASSETS

 

(Unaudited)

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

11,453,000

 

$

11,002,000

 

Marketable securities

 

 

2,500,000

 

Accounts receivable, net

 

2,105,000

 

1,198,000

 

Inventories

 

3,228,000

 

2,924,000

 

Prepaid expenses and other current assets

 

249,000

 

320,000

 

Total current assets

 

17,035,000

 

17,944,000

 

Property and equipment, at cost

 

9,752,000

 

9,619,000

 

Less:  accumulated depreciation

 

(8,175,000

)

(7,679,000

)

 

 

1,577,000

 

1,940,000

 

Long-term deposits

 

143,000

 

143,000

 

Notes receivable from officers

 

59,000

 

59,000

 

Total assets

 

$

18,814,000

 

$

20,086,000

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

406,000

 

$

845,000

 

Accrued expenses and other current liabilities

 

1,003,000

 

1,703,000

 

Customer deposit

 

 

327,000

 

Deferred revenue

 

726,000

 

147,000

 

Total current liabilities

 

2,135,000

 

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

 

31,649,000

 

31,640,000

 

Treasury stock (at cost, 57,663 shares)

 

(280,000

)

(280,000

)

Accumulated deficit

 

(14,790,000

)

(14,396,000

)

Total stockholders’ equity

 

16,679,000

 

17,064,000

 

Total liabilities and stockholders’ equity

 

$

18,814,000

 

$

20,086,000

 

 

 


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