-----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, G19Jg1FptBSW9/5ADuLBU5R0DkFH9ujKnPZKGvs/Q78Y91cqJYhjrYxTjg0EZK9A gsWhp7KMd1L2Kfj+vTp8Zw== 0001104659-04-005878.txt : 20040227 0001104659-04-005878.hdr.sgml : 20040227 20040227094243 ACCESSION NUMBER: 0001104659-04-005878 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20040227 ITEM INFORMATION: ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20040227 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: 04632722 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 a04-2916_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):   February 27, 2004

 

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 February 27, 2004.

 

ITEM 12:  RESULTS OF OPERATIONS AND FINANCIAL CONDITION.

 

On February 27, 2004, Anika Therapeutics, Inc. issued a press release (“Press Release”) announcing its financial results for the fourth 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.

 

Such information, including the exhibits attached hereto, shall not be deemed filed for any purpose, including for purposes of, Section 18 of the Securities and Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 of the Exchange Act, regardless of any general incorporation language in such filing.

 

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 February 27, 2004.

 

 

ANIKA THERAPEUTICS, INC.

 

 

 

 

February 27, 2004

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 February 27, 2004

 

4


EX-99.1 3 a04-2916_1ex99d1.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) 866-6060

(781) 932-6616

 

 

 

 

ANIKA THERAPEUTICS REPORTS 2003 FOURTH QUARTER AND
YEAR-END FINANCIAL RESULTS

 

WOBURN, Mass. – February 27, 2004 – Anika Therapeutics, Inc. (NASDAQ:ANIK) today announced financial results for the fourth quarter and year ended December 31, 2003.

 

Marking the company’s first full year of profitable operations since 1998, net income for the year ended December 31, 2003 was $827,000, or $0.08 per diluted share, compared with a net loss of $3,040,000, or $0.31 per diluted share, for 2002.  Revenues grew 17% to $15,404,000 from $13,187,000 last year.

 

For the 2003 fourth quarter, net income totaled $801,000, or $0.07 per fully diluted share, compared with net income of $829,000, or $0.08 per diluted share, in the fourth quarter of 2002.  Revenues for the quarter increased 12% to $5,014,000 from $4,471,000 for the same period last year.  Results for the latest quarter included recognition of $846,000 in revenue previously deferred for the first three quarters of 2003 in accordance with Anika’s revenue recognition policies compared with deferred revenue of $839,000 recognized in the 2002 fourth quarter.

 

“In the last several months we’ve achieved some highly significant milestones for the company,” said Charles H. Sherwood, Ph.D., president and chief executive officer.  “In December we signed a multi-year U.S. licensing and supply agreement with Johnson & Johnson’s Ortho Biotech Products, L.P. for OrthoVisc®, our treatment for osteoarthritis of the knee.  In February we received final marketing approval from the U.S. Food and Drug Administration (FDA) for OrthoVisc. With these achievements behind us, our initial focus for 2004 is on supporting Ortho Biotech’s U.S. launch for OrthoVisc and to move two potential therapies in our product pipeline—one for cosmetic tissue augmentation and another for preventing post-surgical adhesions—into human clinical trials,” he added.

 

(more)

 



 

Anika received an initial payment of $2 million from Ortho Biotech in the fourth quarter of 2003 and has also received a milestone payment of $20 million in the first quarter of 2004 as a result of the FDA approval.  Commencing in the first quarter of 2004 these cash payments are to be recognized as revenue ratably over the remaining initial ten-year term of the agreement.

 

Gross margins were 48% and 55% for the full year and fourth quarter of 2003, respectively.   This compares with 39% and 59% for the corresponding periods in 2002.  The full-year improvement stemmed from a combination of manufacturing efficiency gains and higher margin product mix, while fourth quarter of 2003 margins reflected lower production levels compared to the same quarter last year.

 

Research and development expenses decreased 17% for the fourth quarter and 34% for the full year of 2003.  The decrease was primarily due to lower costs associated with the clinical trial for OrthoVisc in 2003 compared to 2002.  Selling, general and administrative (SG&A) expenses for the fourth quarter increased 20% compared with the fourth quarter of 2002 mainly due to personnel related costs and outside and professional service fees.  SG&A expenses decreased 5% on a year-over-year basis, mainly due to lower overall outside and professional service fees.

 

Cash and restricted cash at December 31, 2003 totaled $15.4 million compared with cash and marketable securities of $13.5 million at December 31, 2002.

 

 

Conference Call Information

 

The company will hold a conference call to review its financial results on Friday, February 27, 2004 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 http://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 Friday, February 27.

 

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,

 

2



 

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.  Anika products include OrthoVisc®, a treatment for osteoarthritis of the knee available internationally and marketed in the U.S. by Ortho Biotech Products, L.P., and Hyvisc®, a treatment for equine osteoarthritis marketed in the U.S. by Boehringer Ingelheim Vetmedica, Inc.  Anika manufactures Amviscand Amvisc Plus, HA viscoelastic products for ophthalmic surgery, for Bausch & Lomb.  It also produces CoEase, which is marketed by Advanced Medical Optics, Inc., STAARVISC-II distributed by STAAR Surgical Company and Shellgel 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 expectations of the size of the United States and European markets, including Germany and France, for osteoarthritis of the knee, (vii) the Company’s intention to increase market share for ORTHOVISC® in international and domestic markets or otherwise penetrate growing markets for osteoarthritis of the knee,  (viii) the Company’s corporate objectives and research and development and collaboration opportunities, including, without limitation, intended preclinical development of potential cosmetic tissue augmentation products and commencement of INCERT® clinical trials and (ix) the timing and results of the U.S. launch for ORTHOVISC®.  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, 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, German, Canadian and French economies, 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, (iii) new distribution arrangements, including the agreement with Ortho Biotech Products, L.P. pertaining to ORTHOVISC®, will not result in meaningful sales of the Company’s products, (iv) the Company will be unable to achieve performance and sales threshold milestones in its distribution agreements, (v) competitive products will adversely impact the Company’s product sales, (vi) the estimated size(s) of the markets which the Company has targeted its products will fail to be achieved, or (vii) increased sales of the Company’s products, including HYVISC®, ORTHOVISC®, or its ophthalmic products, will not continue or sales will decrease or not reach historical sales levels, or even if such increases occur that such increases will improve gross margins, 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

 

3



 

 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 September 30, 2003 and Current Reports on Form 8-K, as well as those described in the Company’s other press releases and SEC filings.

 

#  #  #

 

4



 

Anika Therapeutics, Inc. and Subsidiaries
Consolidated Statements of Operations

 

 

 

Quarter Ended
December 31,

 

Year Ended
December 31,

 

 

 

2003

 

2002

 

2003

 

2002

 

 

 

 

 

 

 

 

 

 

 

Product revenue

 

$

4,992,000

 

$

4,439,000

 

$

15,330,000

 

$

13,129,000

 

License revenue

 

22,000

 

32,000

 

74,000

 

58,000

 

Total revenue

 

5,014,000

 

4,471,000

 

15,404,000

 

13,187,000

 

Cost of product revenue

 

2,260,000

 

1,845,000

 

8,005,000

 

8,109,000

 

Gross profit

 

2,754,000

 

2,626,000

 

7,399,000

 

5,078,000

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

656,000

 

789,000

 

2,595,000

 

3,928,000

 

Selling, general and administrative

 

1,264,000

 

1,057,000

 

4,209,000

 

4,425,000

 

Total operating expenses

 

1,920,000

 

1,846,000

 

6,804,000

 

8,353,000

 

Income (loss) from operations

 

834,000

 

780,000

 

595,000

 

(3,275,000

)

Interest (income) expense, net

 

(33,000

)

(54,000

)

(144,000

)

(240,000

)

Income (loss) before provision for income taxes

 

867,000

 

834,000

 

739,000

 

(3,035,000

)

Provision for income taxes

 

66,000

 

5,000

 

(88,000

)

5,000

 

Net income (loss)

 

$

801,000

 

$

829,000

 

$

827,000

 

$

(3,040,000

)

 

 

 

 

 

 

 

 

 

 

Basic net earnings (loss) per share

 

$

0.08

 

$

0.08

 

$

0.08

 

$

(0.31

)

Basic shares outstanding

 

9,979,068

 

9,934,280

 

9,953,733

 

9,934,280

 

 

 

 

 

 

 

 

 

 

 

Diluted net earnings (loss) per share

 

$

0.07

 

$

0.08

 

$

0.08

 

$

(0.31

)

Diluted shares outstanding

 

11,188,042

 

9,968,860

 

10,849,610

 

9,934,280

 

 

5



 

Anika Therapeutics, Inc. and Subsidiaries
Consolidated Balance Sheets

 

 

 

December 31,
2003

 

December 31,
2002

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

14,592,000

 

$

11,002,000

 

Restricted cash

 

818,000

 

 

Marketable securities

 

 

2,500,000

 

Accounts receivable, net

 

1,421,000

 

1,198,000

 

Inventories

 

3,627,000

 

2,924,000

 

Prepaid expenses and other current assets

 

81,000

 

320,000

 

Total current assets

 

20,539,000

 

17,944,000

 

Property and equipment

 

9,875,000

 

9,619,000

 

Less accumulated depreciation

 

(8,684,000

)

(7,679,000

)

Net property and equipment

 

1,191,000

 

1,940,000

 

Long-term deposits

 

143,000

 

143,000

 

Loan receivable officer

 

 

59,000

 

Total assets

 

$

21,873,000

 

$

20,086,000

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

349,000

 

$

845,000

 

Other accrued expenses

 

1,297,000

 

1,703,000

 

Customer deposit

 

 

326,000

 

Deferred revenue

 

378,000

 

148,000

 

Income taxes payable

 

65,000

 

 

Total current liabilities

 

2,089,000

 

3,022,000

 

 

 

 

 

 

 

Long Term Deferred Revenue

 

1,800,000

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Common stock

 

100,000

 

100,000

 

Additional paid-in capital

 

31,480,000

 

31,640,000

 

Treasury stock

 

(27,000

)

(280,000

)

Accumulated deficit

 

(13,569,000

)

(14,396,000

)

Total stockholders’ equity

 

17,984,000

 

17,064,000

 

Total liabilities and stockholders’ equity

 

$

21,873,000

 

$

20,086,000

 

 

6


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