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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 SEPTEMBER 30, 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 November 7, 2003, there were 323,824,431 shares of the registrant’s common stock outstanding, par value $0.01.



 


TABLE OF CONTENTS

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
(a) Exhibits:
SIGNATURES
CEO CERTIFICATION PURSUANT SECTION 302
CFO CERTIFICATION PURSUANT SECTION 302
CEO CERTIFICATION PURSUANT SECTION 906
CFO CERTIFICATION PURSUANT SECTION 906


Table of Contents

VIRAGEN, INC. AND SUBSIDIARIES

INDEX

         
        Page
       
PART I   FINANCIAL INFORMATION    
         
Item 1.   Financial Statements    
             
    1.)   Consolidated condensed statements of operations (unaudited) for the three months ended September 30, 2003 and 2002   3
             
    2.)   Consolidated condensed balance sheets as of September 30, 2003 (unaudited) and June 30, 2003   4
             
    3.)   Consolidated condensed statements of cash flows (unaudited) for the three months ended September 30, 2003 and 2002   5
             
    4.)   Notes to consolidated condensed financial statements (unaudited)   6
         
Item 2.   Management’s Discussion and Analysis of Financial Condition and Results of Operations       23
         
Item 3.   Quantitative and Qualitative Disclosures About Market Risk       34
         
Item 4.   Controls and Procedures       35
         
PART II   OTHER INFORMATION    
         
Item 2.   Changes in Securities and Use of Proceeds       36
         
Item 5.   Other Information       36
         
Item 6.   Exhibits and Reports on Form 8-K       37
             
SIGNATURES       38

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VIRAGEN, INC. AND SUBSIDIARIES

CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
                   
      Three Months Ended
      September 30,
     
      2003   2002
     
 
Product sales
  $ 51,606     $ 344,885  
 
Costs and expenses
               
 
Cost of sales
    369,007       318,173  
 
Research and development
    814,422       832,328  
 
Selling, general and administrative
    1,466,263       1,731,248  
 
Amortization of intangible assets
    37,413       57,017  
 
Interest and other income
    (223,224 )     (41,604 )
 
Interest expense
    1,791,632       811,268  
 
   
     
 
 
Loss before income taxes and minority interest
    (4,203,907 )     (3,363,545 )
 
Income tax benefit
    10,957       19,386  
Minority interest in net loss of subsidiary
    289,697       329,475  
 
   
     
 
Net loss
    (3,903,253 )     (3,014,684 )
Deduct required dividends on convertible preferred stock
    662       662  
 
   
     
 
Net loss attributable to common stock
  $ (3,903,915 )   $ (3,015,346 )
 
   
     
 
Basic and diluted net loss per share of common stock, after deduction for required dividends on convertible preferred stock
  $ (0.01 )   $ (0.03 )
 
   
     
 
 
Weighted average common shares – basic and diluted
    273,360,798       106,868,182  
 
   
     
 

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

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VIRAGEN, INC. AND SUBSIDIARIES

CONSOLIDATED CONDENSED BALANCE SHEETS
                     
        September 30,   June 30,
        2003   2003
       
 
        (Unaudited)        
ASSETS
               
 
               
Current assets
               
 
Cash and cash equivalents
  $ 8,381,744     $ 5,942,501  
 
Accounts receivable
    153,668       105,334  
 
Inventories
    3,462,653       3,311,583  
 
Prepaid expenses
    493,377       256,778  
 
Other current assets
    398,305       633,637  
 
   
     
 
   
Total current assets
    12,889,747       10,249,833  
 
               
Property, plant and equipment
               
 
Land, building and improvements
    3,592,647       3,524,076  
 
Equipment and furniture
    5,561,477       5,461,096  
 
Construction in progress
    598,581       551,493  
 
   
     
 
 
    9,752,705       9,536,665  
 
Less accumulated depreciation
    (3,814,206 )     (3,552,117 )
 
   
     
 
 
    5,938,499       5,984,548  
Goodwill
    10,107,914       9,678,302  
Developed technology, net
    1,912,787       1,869,122  
Deposits and other assets
    85,612       85,612  
 
   
     
 
 
  $ 30,934,559     $ 27,867,417  
 
   
     
 
 
               
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
 
               
Current liabilities
               
 
Accounts payable
  $ 711,476     $ 1,666,769  
 
Accrued expenses and other liabilities
    707,108       996,399  
 
Convertible debentures
    864,737       4,051,762  
 
Lines of credit and short term borrowings
    1,130,011       999,192  
 
Current portion of long-term debt
    92,378       60,421  
 
   
     
 
   
Total current liabilities
    3,505,710       7,774,543  
Royalties payable
    107,866       107,866  
Long-term debt, less current portion
    1,136,511       1,124,335  
Minority interest in subsidiary
    2,446,056       2,596,269  
Deferred income tax liability
    533,239       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; 309,054,200 issued and outstanding at September 30, 2003; 258,586,656 issued and outstanding at June 30, 2003
    3,090,542       2,585,866  
 
Additional paid-in capital
    123,120,902       112,922,621  
 
Accumulated deficit
    (106,194,464 )     (102,290,549 )
 
Accumulated other comprehensive income
    3,185,547       2,499,620  
 
   
     
 
   
Total stockholders’ equity
    23,205,177       15,720,208  
 
   
     
 
 
  $ 30,934,559     $ 27,867,417  
 
   
     
 

See notes to consolidated condensed 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)
                         
            Three Months Ended
            September 30,
           
            2003   2002
           
 
OPERATING ACTIVITIES
               
 
Net loss
  $ (3,903,253 )   $ (3,014,684 )
 
Adjustments to reconcile net loss to net cash used in operating activities:
               
   
Depreciation and amortization
    215,709       211,448  
   
Amortization of intangible assets
    37,413       57,017  
   
Compensation expense (reversal) on stock options and warrants
    21,415       (64,751 )
   
Minority interest in net loss of subsidiary
    (289,697 )     (329,475 )
   
Amortization of discount on convertible debentures and promissory notes
    1,524,628       643,734  
   
Amortization of deferred financing costs
    223,083       53,778  
   
Deferred income tax benefit
    (10,957 )     (19,386 )
   
Increase (decrease) relating to operating activities from:
               
     
Accounts receivable
    (48,334 )     55,014  
     
Inventories
    (151,070 )     (241,755 )
     
Prepaid expenses
    68,755       53,627  
     
Other current assets
    12,249       364,816  
     
Accounts payable
    (959,363 )     485,724  
     
Accrued expenses and other liabilities
    (237,898 )     (368,853 )
     
Notes due from directors
          2,594  
 
   
     
 
       
Net cash used in operating activities
    (3,497,320 )     (2,111,152 )
 
               
INVESTING ACTIVITIES
               
 
Additions to property, plant and equipment
    (44,038 )     (256,073 )
 
   
     
 
       
Net cash used in investing activities
    (44,038 )     (256,073 )
 
               
FINANCING ACTIVITIES
               
 
Net proceeds from private placements
    4,764,940       2,498,310  
 
Net (payments) borrowings on lines of credit and short term promissory notes
    (205,792 )     478,923  
 
Payments on long-term debt
    (8,050 )     (15,972 )
 
Payments on convertible debentures
    (23,649 )     (833,334 )
 
Proceeds from exercise of debt and equity offering warrants
    1,312,241        
 
   
     
 
       
Net cash provided by financing activities
    5,839,690       2,127,927  
Effect of exchange rate fluctuations on cash and cash equivalents
    140,911       (32,699 )
 
   
     
 
Increase (decrease) in cash and cash equivalents
    2,439,243       (271,997 )
Cash and cash equivalents at beginning of period
    5,942,501       765,861  
 
   
     
 
Cash and cash equivalents at end of period
  $ 8,381,744     $ 493,864  
 
   
     
 

     During the three months ended September 30, 2003 and September 30, 2002, we had the following non-cash financing activities:

                 
    Three Months Ended
    September 30,
   
    2003   2002
   
 
Purchase of insurance with notes payable
  $ 301,570     $ 30,886  
Conversion of convertible debentures and accrued interest into common stock
    3,341,602        

See notes to consolidated condensed 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

     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 unauditd 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 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 month period ended September 30, 2003 are not necessarily indicative of the results that may be expected for the fiscal year ending June 30, 2004.

     During the quarter ended September 30, 2003 we incurred a loss of approximately $3,903,000. 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 $106,194,000 as of September 30, 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 $8,382,000 and working capital of approximately $9,384,000 at September 30, 2003. We will require substantial additional funding to support our operations subsequent to June 30, 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.

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

(Unaudited)

NOTE B – ACCOUNTING POLICIES

Accounting Estimates: 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.

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
      September 30,
     
      2003   2002
     
 
Net loss as reported
  $ (3,903,253 )   $ (3,014,684 )
Stock based compensation determined under the fair value method
    (13,160 )     (149,171 )
 
   
     
 
 
Pro forma net loss
    (3,916,413 )     (3,163,855 )
Preferred dividends
    (662 )     (662 )
 
   
     
 
 
Pro forma net loss attributable to common stock
  $ (3,917,075 )   $ (3,164,517 )
 
   
     
 
Pro forma loss per common share after deduction of required dividends on convertible preferred stock:
               
Basic and diluted – as reported
  $ (0.01 )   $ (0.03 )
Basic and diluted – pro forma
  $ (0.01 )   $ (0.03 )

Recent Accounting Pronouncements: In January 2003, FASB issued Interpretation No. 46, Consolidation of Variable Interest Entities (FIN No. 46). FIN No. 46 is an interpretation of Accounting Research Bulletin No. 51, Consolidated Financial Statements, and addresses consolidation by business enterprises of variable interest entities. FIN No. 46 applies immediately to variable interest entities created or obtained after January 31, 2003 and it applies in the first fiscal year or interim period ending after December 15, 2003, to variable interest entities in which an enterprise holds a variable interest that it acquired before February 1, 2003. This pronouncement is not expected to have a material impact on our consolidated financial position, results of operations or cash flows.

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

(Unaudited)

NOTE B – ACCOUNTING POLICIES – (Continued)

     In April 2003, the FASB issued SFAS No. 149, Amendment of Statement 133 on Derivative Instruments and Hedging Activities. SFAS 149 improves financial reporting by requiring that contracts with comparable characteristics be accounted for similarly. SFAS 149 clarifies 1) the circumstances in which a contract with an initial net investment meets the characteristics of a derivative, 2) when a derivative contains a financing component and amends certain other existing pronouncements. This Statement is effective for contracts entered into or modified after June 30, 2003. Adoption of this standard did not have a material impact on our consolidated financial position, results of operations or cash flows.

     In May 2003, the FASB issued SFAS No. 150, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity. SFAS No. 150 requires that certain financial instruments, which under previous guidance were accounted for as equity, be accounted for as liabilities. The financial instruments affected include mandatorily redeemable stock, certain financial instruments that require or may require the issuer to buy back some of its shares in exchange for cash or other assets and certain obligations that can be settled with shares of stock. SFAS No. 150 is effective for all financial instruments entered into or modified after May 31, 2003 and must be applied to existing financial instruments effective after the beginning of the first fiscal period after June 15, 2003. Adoption of this standard did not have a material impact on our consolidated financial position, results of operations or cash flows.

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 into 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 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 September 30, 2003 and June 30, 2003 arose from Viragen International’s acquisition of ViraNative on September 28, 2001 and the subsequent achievement of certain milestones by ViraNative in January 2002 as discussed in Note C. The following table reflects the changes in the carrying amount of goodwill for the three months ended September 30, 2003:

         
Balance as of June 30, 2003
  $ 9,678,302  
Foreign exchange adjustment
    429,612  
 
   
 
Balance as of September 30, 2003
  $ 10,107,914  
 
   
 

     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, the Company determined that no impairment of this asset existed as of April 1, 2003. As of September 30, 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 market values 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 other intangible assets reported in our balance sheets as of September 30, 2003 and June 30, 2003 arose from Viragen International’s acquisition of ViraNative on September 28, 2001.

     As of September 30, 2003 and June 30, 2003, other intangible assets consisted of the following:

                   
      September 30,   June 30,
      2003   2003
     
 
Developed technology, gross
  $ 2,227,218     $ 2,132,555  
Accumulated amortization
    (314,431 )     (263,433 )
 
   
     
 
 
Developed technology, net
  $ 1,912,787     $ 1,869,122  
 
   
     
 

     Developed technology 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 $577,000 as a result of foreign currency fluctuations between the U.S. dollar and the Swedish Krona.

     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.

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

(Unaudited)

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

     The estimated aggregate amortization expense for the fiscal year ending June 30, 2004 and the four succeeding fiscal years is as follows: