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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 10-Q

 

(Mark One)

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

FOR THE QUARTER ENDED DECEMBER 31, 2003

 

OR

 

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

Commission File Number 0-17827

 


 

VIRAGEN INTERNATIONAL, INC.

(Exact name of registrant as specified in its charter)

 


 

Delaware   11-2788282

(State or other jurisdiction of

incorporation or organization)

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

 

865 SW 78th Avenue, Suite 100, Plantation, Florida 33324

(Address of principal executive offices)

 

(954) 233-8377

(Registrant’s telephone number, including area code)

 


 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes x No ¨

 

As of February 9, 2004, there were 68,113,764 shares of the registrant’s common stock outstanding, par value $0.01.

 



Table of Contents

VIRAGEN INTERNATIONAL, INC. AND SUBSIDIARIES

 

INDEX

 

PART I - FINANCIAL INFORMATION

   

Item 1.

  Financial Statements    
   

1)       Consolidated condensed statements of operations (unaudited) for the three and six months ended December 31, 2003 and 2002

   
   

2)       Consolidated condensed balance sheets as of December 31, 2003 (unaudited) and June 30, 2003

   
   

3)       Consolidated condensed statements of cash flows (unaudited) for the six months ended December 31, 2003 and 2002

   
   

4)       Notes to consolidated condensed financial statements (unaudited)

   

Item 2.

  Management’s Discussion and Analysis of Financial Condition and Results of Operations    

Item 3.

  Quantitative and Qualitative Disclosures About Market Risk    

Item 4.

  Controls and Procedures    

PART II - OTHER INFORMATION

   

Item 5.

  Other Information    

Item 6.

  Exhibits and Reports on Form 8-K    

SIGNATURES

   

 

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VIRAGEN INTERNATIONAL, INC. AND SUBSIDIARIES

CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS

(Unaudited)

 

    

Three Months Ended

December 31,


   

Six Months Ended

December 31,


 
     2003

    2002

    2003

    2002

 

Product sales

   $ 60,041     $ 126,592     $ 111,647     $ 471,477  

Costs and expenses

                                

Cost of sales

     532,023       103,784       901,030       421,957  

Research and development

     341,027       235,450       653,296       467,050  

Selling, general and administrative

     939,388       890,359       1,786,172       1,718,125  

Amortization of intangible assets

     38,814       58,108       76,227       115,125  

Interest and other income

     (138,341 )     (75,205 )     (255,966 )     (89,307 )

Interest expense

     44,945       48,819       84,275       98,538  
    


 


 


 


Loss before income taxes

     (1,697,815 )     (1,134,723 )     (3,133,387 )     (2,260,011 )

Income tax benefit

     10,957       19,386       21,914       38,772  
    


 


 


 


Net loss

   $ (1,686,858 )   $ (1,115,337 )   $ (3,111,473 )   $ (2,221,239 )
    


 


 


 


Loss per common share – basic and diluted

   $ (0.02 )   $ (0.02 )   $ (0.05 )   $ (0.05 )
    


 


 


 


Weighted average common shares – basic and diluted

     68,113,764       46,540,427       68,113,764       46,516,083  
    


 


 


 


 

See notes to consolidated condensed financial statements which are an integral part of these statements.

 

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VIRAGEN INTERNATIONAL, INC. AND SUBSIDIARIES

CONSOLIDATED CONDENSED BALANCE SHEETS

 

     December 31,
2003


    June 30,
2003


 
     (Unaudited)        
ASSETS                 

Current assets

                

Cash and cash equivalents

   $ 319,964     $ 264,224  

Accounts receivable

     74,867       105,334  

Inventories

     3,665,239       3,311,583  

Prepaid expenses

     126,211       173,254  

Other current assets

     197,907       61,184  
    


 


Total current assets

     4,384,188       3,915,579  

Property, plant and equipment

                

Land, building and improvements

     3,263,769       3,143,965  

Equipment and furniture

     4,736,750       4,625,543  

Construction in progress

     1,383,830       551,493  
    


 


       9,384,349       8,321,001  

Less accumulated depreciation

     (3,122,476 )     (2,708,844 )
    


 


       6,261,873       5,612,157  

Goodwill

     10,731,744       9,678,302  

Developed technology, net

     1,989,109       1,869,122  
    


 


     $ 23,366,914     $ 21,075,160  
    


 


LIABILITIES AND STOCKHOLDERS’ EQUITY                 

Current liabilities

                

Accounts payable

   $ 870,058     $ 1,300,919  

Accrued expenses and other liabilities

     398,727       598,157  

Line of credit

     842,391       999,192  

Current portion of long-term debt

     129,161       60,421  
    


 


Total current liabilities

     2,240,337       2,958,689  

Long-term debt, less current portion

     1,228,755       1,124,335  

Advances from parent

     7,999,992       3,680,530  

Deferred income tax liability

     522,282       544,196  

Commitments and contingencies

                

Stockholders’ equity

                

Common stock, $.01 par value; 90,000,000 shares authorized; 68,113,764 shares issued and outstanding at December 31, 2003 and June 30, 2003

     681,138       681,138  

Additional paid-in capital

     45,537,903       45,537,903  

Accumulated deficit

     (39,062,724 )     (35,951,251 )

Accumulated other comprehensive income

     4,219,231       2,499,620  
    


 


Total stockholders’ equity

     11,375,548       12,767,410  
    


 


     $ 23,366,914     $ 21,075,160  
    


 


 

See notes to consolidated condensed financial statements which are an integral part of these statements.

 

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VIRAGEN INTERNATIONAL, INC. AND SUBSIDIARIES

CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS

(Unaudited)

 

    

Six Months Ended

December 31,


 
     2003

    2002

 

OPERATING ACTIVITIES

                

Net loss

   $ (3,111,473 )   $ (2,221,239 )

Adjustments to reconcile net loss to net cash used in operating activities:

                

Depreciation

     374,103       354,055  

Amortization of intangible assets

     76,227       115,125  

Loss on sale of property, plant, and equipment

     19,794       8,578  

Deferred income tax benefit

     (21,914 )     (38,772 )

Increase (decrease) relating to operating activities from:

                

Accounts receivable

     30,467       286,882  

Inventories

     (353,656 )     (972,491 )

Prepaid expenses and other current assets

     (89,680 )     748,914  

Accounts payable and accrued expenses

     (630,291 )     603,441  
    


 


Net cash used in operating activities

     (3,706,423 )     (1,115,507 )

INVESTING ACTIVITIES

                

Additions to property, plant and equipment, net

     (754,295 )     (314,437 )
    


 


Net cash used in investing activities

     (754,295 )     (314,437 )

FINANCING ACTIVITIES

                

Advances from parent

     4,319,462       1,275,652  

Net (payment) borrowing on line of credit

     (247,008 )     87,664  

Net borrowing (payment) on long-term debt

     43,205       (27,391 )
    


 


Net cash provided by financing activities

     4,115,659       1,335,925  

Effect of exchange rate fluctuations on cash

     400,799       40,167  
    


 


Increase (decrease) in cash and cash equivalents

     55,740       (53,852 )

Cash and cash equivalents at beginning of period

     264,224       77,405  
    


 


Cash and cash equivalents at end of period

   $ 319,964     $ 23,553  
    


 


 

See notes to consolidated condensed financial statements which are an integral part of these statements.

 

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VIRAGEN INTERNATIONAL, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS – (Continued)

(Unaudited)

 

NOTE A – OVERVIEW AND BASIS OF PRESENTATION

 

We are engaged in the research, development, manufacture, and sale of a natural human alpha interferon product indicated for treatment of a broad range of viral and malignant diseases. We produce a natural human alpha interferon product under the tradename of Multiferon from human white blood cells, also known as leukocytes. Natural interferon-alpha is one of the body’s most important natural defense mechanisms to foreign substances like viruses, and it also stimulates and modulates the human immune system. In addition, interferon inhibits the growth of various viruses including those associated with diseases like hepatitis, some types of cancer, multiple sclerosis, and severe acute respiratory syndrome (SARS).

 

We are a majority owned subsidiary of Viragen, Inc. (Viragen). As of December 31, 2003, Viragen owned 54,262,745 shares of our common stock representing approximately 79.7% of our 68,113,764 outstanding shares. We operate through our foreign wholly owned subsidiaries, ViraNative AB, a company located in Umeå, Sweden and Viragen (Scotland) Limited, a company located near Edinburgh, Scotland. ViraNative and Viragen (Scotland) house our manufacturing and laboratory facilities.

 

The accompanying interim consolidated condensed financial statements include Viragen International, Inc. and all of its subsidiaries, including those operating outside the United States of America. All significant transactions among our businesses have been eliminated. These statements have been prepared in conformity with accounting principles generally accepted in the United States, consistent in all material respects with those applied in our Annual Report on Form 10-K for the fiscal year ended June 30, 2003, filed with the Securities and Exchange Commission.

 

The accompanying interim consolidated condensed financial statements for Viragen International have been prepared in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, certain information and footnote disclosures normally included in financial statements included in our Annual Report on Form 10-K have been condensed or omitted. Certain amounts in prior periods’ consolidated condensed financial statements have been reclassified to conform to the current periods’ presentation. The reclassifications had no effect on previously reported results of operations. The accompanying interim consolidated condensed financial statements should be read in conjunction with Management’s Discussion and Analysis of Financial Condition and Results of Operations contained in this report and the audited consolidated financial statements and accompanying notes included in our Annual Report on Form 10-K for the year ended June 30, 2003.

 

The preparation of financial statements in accordance with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of income and expenses during the reporting period. The accounting estimates that require management’s most difficult and subjective judgments include: the assessment of recoverability of goodwill and long-lived assets; and the valuation of inventories. Actual results could differ materially from those estimates.

 

The interim financial information is unaudited, but, in the opinion of management, reflects all adjustments, including normal recurring adjustments, considered necessary for a fair presentation of results of the interim periods presented. Operating results for the three and six month periods ended December 31, 2003 are not necessarily indicative of the results that may be expected for the fiscal year ending June 30, 2004.

 

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VIRAGEN INTERNATIONAL, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS – (Continued)

(Unaudited)

 

NOTE A – OVERVIEW AND BASIS OF PRESENTATION – (Continued)

 

During the three and six months ended December 31, 2003 we incurred losses of approximately $1,687,000 and $3,111,000, respectively. During the years ended June 30, 2003, 2002 and 2001, we incurred losses of approximately $5,165,000, $5,591,000, and $7,915,000, respectively. We have an accumulated deficit of approximately $39,063,000 as of December 31, 2003. Management anticipates additional future losses as it commercializes its natural human alpha interferon product and conducts additional research activities and clinical trials to obtain additional regulatory approvals. We had cash and cash equivalents of approximately $320,000 and working capital of approximately $2,144,000 at December 31, 2003. We will require substantial additional funding to support our operations. Historically, Viragen, our parent company, has provided us with the working capital necessary to fund operations. Viragen has agreed to provide us with the working capital necessary to fund our operations through December 31, 2004. Viragen will be required to raise additional funds to support our operations subsequent to December 31, 2004. No assurance can be given that additional capital will be available when required or upon terms acceptable to Viragen.

 

NOTE B – STOCK BASED COMPENSATION

 

As permitted under Statement of Financial Accounting Standards (SFAS) No. 148, Accounting for Stock-Based Compensation—Transition and Disclosure, which amended SFAS No. 123, Accounting for Stock-Based Compensation, our employee stock option plan is accounted for under Accounting Principles Board Opinion No. 25 (APB 25), Accounting for Stock Issued to Employees, and related interpretations. Compensation expense for a stock option grant is recognized if the exercise price is less than the fair value of our common stock on the grant date.

 

The following table illustrates the effect on net loss and loss per common share if we had applied the fair value method to measure stock based compensation as required under the disclosure provisions of SFAS No. 123, Accounting for Stock Based Compensation.

 

    

Three Months Ended

December 31,


   

Six Months Ended

December 31,


 
     2003

    2002

    2003

    2002

 

Net loss as reported

   $ (1,686,858 )   $ (1,115,337 )   $ (3,111,473 )   $ (2,221,239 )

Stock based compensation determined under the fair value method

     (1,740 )     (7,901 )     (8,363 )     (22,219 )
    


 


 


 


Pro forma net loss

   $ (1,688,598 )   $ (1,123,238 )   $ (3,119,836 )   $ (2,243,458 )
    


 


 


 


Loss per common share:

                                

Basic and diluted – as reported

   $ (0.02 )   $ (0.02 )   $ (0.05 )   $ (0.05 )

Basic and diluted – pro forma

   $ (0.02 )   $ (0.02 )   $ (0.05 )   $ (0.05 )

 

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VIRAGEN INTERNATIONAL, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS – (Continued)

(Unaudited)

 

NOTE C – ACQUISITION

 

On September 28, 2001, we acquired all of the outstanding shares of BioNative AB (“BioNative”), a privately held biotechnology company located in Umeå, Sweden. BioNative manufactured a natural human alpha interferon product called Interferon Alfanative®. Subsequent to the acquisition, BioNative was renamed ViraNative and Interferon Alfanative was further developed, and is now marketed as Multiferon.

 

The initial purchase consideration consisted of 2,933,190 shares of Viragen International common stock. In January 2002, ViraNative achieved two milestones as defined in the acquisition agreement. As a result, the former shareholders of ViraNative were issued an additional 8,799,570 shares of Viragen International common stock. In connection with the acquisition, the former shareholders of ViraNative are entitled to additional shares of Viragen International common stock contingent upon the attainment of certain milestones related to regulatory approvals:

 

  8,799,570 additional shares when and if the Mutual Recognition Procedures a