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

Commission File Number 001-15823


VIRAGEN, INC.

(Exact name of registrant as specified in its charter)


     
Delaware
(State or other jurisdiction of
incorporation or organization)
  59-2101668
(I.R.S. Employer Identification No.)

865 SW 78th Avenue, Suite 100, Plantation, Florida 33324
(Address of principal executive offices)

(954) 233-8746
(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 o

As of February 5, 2004, there were 365,919,879 shares of the registrant’s common stock outstanding, par value $0.01.



 


TABLE OF CONTENTS

PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
CONSOLIDATED CONDENSED BALANCE SHEETS
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
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 2. Changes in Securities and Use of Proceeds
Item 5. Other Information
Item 6. Exhibits and Reports on Form 8-K
SIGNATURES
Section 302 Certification - CEO
Section 302 Certification - CFO
Section 906 Certification - CEO
Section 906 Certification - CFO


Table of Contents

VIRAGEN, 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 2. Changes in Securities and Use of Proceeds

Item 5. Other Information

Item 6. Exhibits and Reports on Form 8-K

SIGNATURES

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VIRAGEN, INC. AND SUBSIDIARIES

CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
                                   
      Three Months Ended   Six Months Ended
      December 31,   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
    811,318       914,225       1,625,740       1,746,553  
 
Selling, general and administrative
    1,727,258       1,715,741       3,193,521       3,446,989  
 
Amortization of intangible assets
    38,814       58,108       76,227       115,125  
 
Interest and other income
    (252,992 )     (123,155 )     (476,216 )     (164,759 )
 
Interest expense
    4,895,398       1,942,195       6,687,030       2,753,463  
 
   
     
     
     
 
Loss before income taxes and minority interest
    (7,691,778 )     (4,484,306 )     (11,895,685 )     (7,847,851 )
 
Income tax benefit
    10,957       19,386       21,914       38,772  
 
Minority interest in loss of subsidiary
    343,025       332,286       632,722       661,761  
 
   
     
     
     
 
Net loss
    (7,337,796 )     (4,132,634 )     (11,241,049 )     (7,147,318 )
Deduct required dividends on convertible preferred stock, Series A
    663       663       1,325       1,325  
 
   
     
     
     
 
Net loss attributable to common stock
  $ (7,338,459 )   $ (4,133,297 )   $ (11,242,374 )   $ (7,148,643 )
 
   
     
     
     
 
Basic and diluted net loss per share of common stock, after deduction for required dividends on convertible preferred stock
  $ (0.02 )   $ (0.04 )   $ (0.04 )   $ (0.06 )
Weighted average common shares — basic and diluted
    325,314,218       117,196,983       299,337,508       112,032,583  

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

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VIRAGEN, INC. AND SUBSIDIARIES

CONSOLIDATED CONDENSED BALANCE SHEETS
                         
            December 31,   June 30,
            2003   2003
           
 
            (Unaudited)        
       
ASSETS
               
Current assets
               
   
Cash and cash equivalents
  $ 11,147,672     $ 5,942,501  
   
Accounts receivable
    74,867       105,334  
   
Inventories
    3,665,239       3,311,583  
   
Prepaid expenses
    375,176       256,778  
   
Other current assets
    256,197       633,637  
 
   
     
 
     
Total current assets
    15,519,151       10,249,833  
Property, plant and equipment
               
   
Land, building and improvements
    3,643,880       3,524,076  
   
Equipment and furniture
    5,604,409       5,461,096  
   
Construction in progress
    1,383,830       551,493  
 
   
     
 
 
    10,632,119       9,536,665  
   
Less accumulated depreciation
    (4,031,995 )     (3,552,117 )
 
   
     
 
 
    6,600,124       5,984,548  
Goodwill
    10,731,744       9,678,302  
Developed technology, net
    1,989,109       1,869,122  
Deposits and other assets
    85,612       85,612  
 
   
     
 
 
  $ 34,925,740     $ 27,867,417  
 
   
     
 
 
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
Current liabilities
               
   
Accounts payable
  $ 1,007,154     $ 1,666,769  
   
Accrued expenses and other liabilities
    728,849       996,399  
   
Convertible debentures
          4,051,762  
   
Lines of credit and short term borrowings
    926,105       999,192  
   
Current portion of long-term debt
    129,161       60,421  
 
   
     
 
     
Total current liabilities
    2,791,269       7,774,543  
Royalties payable
    107,866       107,866  
Long-term debt, less current portion
    1,228,755       1,124,335  
Minority interest in subsidiary
    2,313,232       2,596,269  
Deferred income tax liability
    522,282       544,196  
Commitments and contingencies
               
Stockholders’ equity
               
   
Convertible 10% Series A cumulative preferred stock, $1.00 par value. Authorized 375,000 shares; issued and outstanding 2,650 shares. Liquidation preference value: $10 per share, aggregating $26,500
    2,650       2,650  
   
Common stock, $.01 par value; 700,000,000 shares authorized; 358,566,420 issued and outstanding at December 31, 2003; 258,586,656 issued and outstanding at June 30, 2003
    3,585,665       2,585,866  
   
Additional paid-in capital
    134,545,699       112,922,621  
   
Accumulated deficit
    (113,532,923 )     (102,290,549 )
   
Accumulated other comprehensive income
    3,361,245       2,499,620  
 
   
     
 
     
Total stockholders’ equity
    27,962,336       15,720,208  
 
   
     
 
 
  $ 34,925,740     $ 27,867,417  
 
   
     
 

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

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VIRAGEN, INC. AND SUBSIDIARIES

CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
                       
          Six Months Ended
          December 31,
         
          2003   2002
         
 
OPERATING ACTIVITIES
               
 
Net loss
  $ (11,241,049 )   $ (7,147,318 )
 
Adjustments to reconcile net loss to net cash used in operating activities:
               
   
Depreciation and amortization
    440,348       423,931  
   
Amortization of intangible assets
    76,227       115,125  
   
Loss on sale of property, plant and equipment
    19,794       8,578  
   
Compensation expense (reversal) on stock options and warrants
    20,259       (61,493 )
   
Minority interest in loss of subsidiary
    (632,722 )     (661,761 )
   
Amortization of discount on convertible debentures and promissory notes
    6,141,296       2,422,951  
   
Amortization of deferred financing costs
    454,735       144,037  
   
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
    183,172       66,424  
   
Other current assets
    (77,295 )     826,978  
   
Accounts payable
    (663,864 )     726,597  
   
Accrued expenses and other liabilities
    (216,820 )     (233,306 )
   
Notes due from directors
          4,836  
 
   
     
 
     
Net cash used in operating activities
    (5,841,022 )     (4,088,802 )
INVESTING ACTIVITIES
               
 
Additions to property, plant and equipment, net
    (786,401 )     (329,349 )
 
   
     
 
     
Net cash used in investing activities
    (786,401 )     (329,349 )
FINANCING ACTIVITIES
               
 
Net proceeds from private equity placements
    9,007,733       2,735,523  
 
Net payments on lines of credit and short term promissory notes
    (460,613 )     (325,626 )
 
Net borrowings (payments) on long-term debt
    43,205       (27,391 )
 
Net proceeds from issuance of convertible debentures
          2,308,250  
 
Payments on convertible debentures
    (65,316 )     (1,111,113 )
 
Collections on notes due from directors
          50,000  
 
Proceeds from exercise of debt and equity offering warrants, net
    2,906,786       14,433  
 
   
     
 
     
Net cash provided by financing activities
    11,431,795       3,644,076  
Effect of exchange rate fluctuations on cash
    400,799       40,167  
 
   
     
 
Increase (decrease) in cash and cash equivalents
    5,205,171       (733,908 )
Cash and cash equivalents at beginning of period
    5,942,501       765,861  
 
   
     
 
Cash and cash equivalents at end of period
  $ 11,147,672     $ 31,953  
 
   
     
 

     During the six months ended December 31, 2003 and December 31, 2002, we had the following non-cash financing activities:

                 
    Six Months Ended
    December 31,
   
    2003   2002
   
 
Purchase of insurance with notes payable
  $ 301,570     $ 30,886  
Conversion of convertible debentures and accrued interest into common stock
    7,264,036       1,285,556  

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

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VIRAGEN, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
(Unaudited)

NOTE A – OVERVIEW AND BASIS OF PRESENTATION

     We are a biopharmaceutical company 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 are also developing innovative technologies aimed at improving the manufacturing processes used to manufacture certain medical therapies. Specifically, we are primarily focused on three fields of research and development:

    human leukocyte derived interferon – natural alpha interferon derived from human white blood cells for the treatment of a wide range of viral and malignant diseases.
 
    avian transgenics technologies designed to produce protein-based drugs inside the egg whites of transgenic developed chickens.
 
    oncological therapies – therapeutic proteins for the treatment of targeted cancers.

     We own approximately 79.7% of Viragen International, Inc. Viragen International operates primarily through its wholly owned subsidiaries, ViraNative AB, a company located in Umea, Sweden, and Viragen (Scotland) Limited, a company located near Edinburgh, Scotland. ViraNative and Viragen (Scotland) house our manufacturing and laboratory facilities.

     The accompanying unaudited interim consolidated condensed financial statements include Viragen, Inc., Viragen International, Inc. and all 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 unaudited interim consolidated condensed financial statements for Viragen, Inc. 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. The accompanying unaudited 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.

     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.

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VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS — (Continued)
(Unaudited)

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

     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. During the three months ended December 31, 2003, we recorded an adjustment of non-cash interest expense totaling approximately $1.4 million as a result of the revaluation of warrants issued in connection with the April and June 2003 convertible debentures. Please see Note F and Management’s Discussion and Analysis of Financial Condition and Results of Operations. 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.

     During the three and six months ended December 31, 2003 we incurred losses of approximately $7,338,000 and $11,241,000, respectively. During the years ended June 30, 2003, 2002 and 2001, we incurred significant losses of approximately $17,349,000, $11,089,000, and $11,008,000, respectively. We have an accumulated deficit of approximately $113,533,000 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 $11,148,000 and working capital of approximately $12,728,000 at December 31, 2003. We will require substantial additional funding to support our operations subsequent to December 31, 2004. Management’s plans include obtaining additional capital through equity and debt financings. No assurance can be given that additional capital will be available when required or upon terms acceptable to us.

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.

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VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS — (Continued)
(Unaudited)

NOTE B – STOCK BASED COMPENSATION – (Continued)

     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   Six Months Ended
    December 31,   December 31,
   
 
    2003   2002   2003   2002
   
 
 
 
Net loss as reported
  $ (7,337,796 )   $ (4,132,634 )   $ (11,241,049 )   $ (7,147,318 )
Stock based compensation determined under the fair value method
    (7,668 )     (132,320 )     (23,912 )     (282,491 )
 
   
     
     
     
 
Proforma net loss
    (7,345,464 )     (4,264,954 )     (11,264,961 )     (7,429,809 )
Preferred dividends, Series A
    (663 )     (663 )     (1,325 )     (1,325 )
 
   
     
     
     
 
Pro forma net loss attributable to common stock
  $ (7,346,127 )   $ (4,265,617 )   $ (11,266,286 )   $ (7,431,134 )
 
   
     
     
     
 
Proforma loss per common share after deduction of required dividends on convertible preferred stock:
                               
Basic and diluted – as reported
  $ (0.02 )   $ (0.04 )   $ (0.04 )   $ (0.06 )
Basic and diluted – pro forma
  $ (0.02 )   $ (0.04 )   $ (0.04 )   $ (0.07 )

NOTE C – ACQUISITION

     On September 28, 2001, Viragen International, Inc., our majority owned subsidiary, 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 application has received the approval of the requisite national and EU regulatory authorities for the use, sale and marketing of Multiferon in certain countries which must include Germany; and
 
    2,933,190 additional shares when and if Multiferon has been approved by the requisite regulatory bodies in the EU for the treatment of Melanoma or when Multiferon has been approved by the requisite regulatory bodies for sale in the USA.

If and as each of these milestones is met, the additional shares of Viragen International will be issued.

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VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS — (Continued)
(Unaudited)

NOTE D – GOODWILL AND OTHER INTANGIBLE ASSETS

     The goodwill reported in our balance sheets as of December 31, 2003 and June 30, 2003 arose from Viragen International’s acquisition of ViraNative on September 28, 2001 and the subsequent attainment of certain milestones by ViraNative in January 2002 as discussed in Note C. Subsequent to the initial recording of goodwill, the gross carrying amount has increased by approximately $3,144,000 as a result of foreign currency fluctuations between the U.S. dollar and the Swedish Krona. The following table reflects the changes in the carrying amount of goodwill for the six months ended December 31, 2003:

         
Balance as of June 30, 2003
  $ 9,678,302  
Foreign exchange adjustment
    1,053,442  
 
   
 
Balance as of December 31, 2003
  $ 10,731,744  
 
   
 

     In accordance with SFAS No. 142, Goodwill and Other Intangible Assets, this goodwill is not amortized but is reviewed for impairment on an annual basis or sooner if indicators of impairment arise. During the fourth quarter of our fiscal year ended June 30, 2003, we completed the annual impairment review of our goodwill with the assistance of an independent valuation firm. Based on the results of the review, we determined that no impairment of this asset existed as of April 1, 2003. As of December 31, 2003, we are not aware of any items or events that would cause us to adjust the recorded value of our goodwill for impairment. Future changes in the estimates used to conduct the impairment review, including revenue projections or the fair market value of Viragen International’s common stock, could cause our analysis to indicate that our goodwill is impaired in subsequent periods and result in a write-off of a portion or all of our goodwill.

     The developed technology intangible asset reported in our balance sheets as of December 31, 2003 and June 30, 2003 arose from Viragen International’s acquisition of ViraNative on September 28, 2001. A detail of our developed technology intangible asset as of December 31, 2003 and June 30, 2003 is as follows:

                   
      December 31,   June 30,
      2003   2003
     
 
Developed technology, gross
  $ 2,364,675     $ 2,132,555  
Accumulated amortization
    (375,566 )     (263,433 )
 
   
     
 
 
Developed technology, net
  $ 1,989,109     $ 1,869,122  
 
   
     
 

     Our developed technology asset consists of the production and purification methods developed by ViraNative prior to the acquisition by Viragen International. This technology was complete and ViraNative had been selling the resultant natural interferon product prior to the acquisition by Viragen International. Developed technology was recorded at its estimated fair value at the date of acquisition. Subsequent to the initial recording of this intangible asset, the gross carrying amount has increased by approximately $715,000 as a result of foreign currency fluctuations between the U.S. dollar and the Swedish Krona.

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VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS — (Continued)
(Unaudited)

NOTE D – GOODWILL AND OTHER INTANGIBLE ASSETS – (Continued)

     Developed technology is being amortized over its estimated useful life of approximately 14 years. The 14-year life assigned to this asset was determined using a weighted average of the remaining lives of the patents on the various components of the production and purification processes.

     The estimated aggregate amortization expense for the fiscal year ending J