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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, 2002
     
    OR
     
(  )   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   59-2101668
(State or other jurisdiction of   (I.R.S. Employer Identification No.)
incorporation or organization)    

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 [  ]

As of February 13, 2003 there were 147,695,712 shares of the issuer’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 1. Legal Proceedings
Item 4. Submission of Matters to a Vote of Security Holders
Item 6. Exhibits and Reports on Form 8-K
SIGNATURES
CERTIFICATIONS


Table of Contents

VIRAGEN, INC. AND SUBSIDIARIES

INDEX

       
PART I. FINANCIAL INFORMATION
  3
Item 1. Financial Statements
  3
 
1.) Consolidated condensed statements of operations for the three and six months ended December 31, 2002 and 2001
  3
 
2.) Consolidated condensed balance sheets as of December 31, 2002 and June 30, 2002
  4
 
3.) Consolidated condensed statements of cash flows for the six months ended December 31, 2002 and 2001
  5
 
4.) Notes to consolidated condensed financial statements
  6
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
  18
Item 3. Quantitative and Qualitative Disclosures About Market Risk
  31
Item 4. Controls and Procedures
  32
PART II. OTHER INFORMATION
  33
Item 1. Legal Proceedings
  33
Item 4. Submission of Matters to a Vote of Security Holders
  35
Item 6. Exhibits and Reports on Form 8-K
  36
SIGNATURES
  37
CERTIFICATION OF CEO
  38
CERTIFICATION OF CFO
  39

2


Table of Contents

PART I — FINANCIAL INFORMATION

Item 1. Financial Statements

VIRAGEN, INC. AND SUBSIDIARIES
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)

                                   
      Three Months Ended   Six Months Ended
      December 31,   December 31,
     
 
      2002   2001   2002   2001
     
 
 
 
Product sales
  $ 126,592     $ 461,892     $ 471,477     $ 461,892  
Costs and expenses
                               
 
Cost of sales
    100,866       443,530       419,039       443,530  
 
Research and development
    855,049       1,347,439       1,687,377       2,839,761  
 
Selling, general and administrative
    1,715,876       1,972,130       3,447,124       3,253,748  
 
Amortization of intangible assets
    58,108       51,518       115,125       51,518  
 
Interest and other income
    (61,196 )     (52,926 )     (102,800 )     (138,312 )
 
Interest expense
    1,942,195       46,928       2,753,463       48,756  
 
   
     
     
     
 
Loss before income taxes and minority interest
    (4,484,306 )     (3,346,727 )     (7,847,851 )     (6,037,109 )
 
Income tax benefit
    19,386       112       38,772       73,426  
 
Minority interest in loss of subsidiaries
    332,286       264,013       661,761       362,281  
 
   
     
     
     
 
Net loss
    (4,132,634 )     (3,082,602 )     (7,147,318 )     (5,601,402 )
Deduct required dividends on convertible preferred stock, Series A
    663       662       1,325       1,325  
 
   
     
     
     
 
Loss attributable to common stock
  $ (4,133,297 )   $ (3,083,264 )   $ (7,148,643 )   $ (5,602,727 )
 
   
     
     
     
 
Loss per common share, after deduction of required dividends on convertible preferred stock — basic and diluted
  $ (0.04 )   $ (0.03 )   $ (0.06 )   $ (0.06 )
 
   
     
     
     
 
Weighted average common shares — basic and diluted
    117,196,983       99,907,811       112,032,583       99,756,747  
 
   
     
     
     
 

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

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Table of Contents

VIRAGEN, INC. AND SUBSIDIARIES
CONSOLIDATED CONDENSED BALANCE SHEETS

                         
            December 31,   June 30,
            2002   2002
           
 
            (Unaudited)        
       
ASSETS
               
Current assets
               
   
Cash and cash equivalents
  $ 31,953     $ 765,861  
   
Accounts receivable
    63,083       349,965  
   
Inventories
    2,839,059       1,866,568  
   
Prepaid expenses
    381,572       399,626  
   
Other current assets
    328,372       1,033,287  
 
   
     
 
       
Total current assets
    3,644,039       4,415,307  
Property, plant and equipment
               
   
Land, building and improvements
    3,391,675       3,254,701  
   
Equipment and furniture
    5,289,766       5,022,695  
   
Construction in progress
    502,050       375,373  
 
   
     
 
 
    9,183,491       8,652,769  
   
Less accumulated depreciation
    (3,061,248 )     (2,678,299 )
 
   
     
 
 
    6,122,243       5,974,470  
Goodwill
    8,887,444       8,460,940  
Developed technology, net
    1,785,503       1,765,618  
Other intangible assets, net
          50,619  
Deposits and other assets
    129,650       129,650  
 
   
     
 
 
  $ 20,568,879     $ 20,796,604  
 
   
     
 
     
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
Current liabilities
               
   
Accounts payable
  $ 2,334,998     $ 1,583,333  
   
Accrued expenses and other liabilities
    849,098       1,081,079  
   
Convertible debentures
    1,528,636       711,982  
   
Lines of credit and short term promissory notes
    1,023,095       1,294,904  
   
Current portion of long-term debt
    122,408       72,374  
   
Deferred tax liability, current
    43,828       60,686  
 
   
     
 
       
Total current liabilities
    5,902,063       4,804,358  
Royalties payable
    107,866       107,866  
Long-term debt, less current portion
    980,408       1,023,948  
Minority interest in subsidiaries
    2,334,094       2,845,616  
Deferred 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. Authorized 150,000,000 shares at December 31, 2002 and June 30, 2002; 127,241,940 issued and 126,396,663 outstanding at December 31, 2002; 104,831,855 issued and 103,986,578 outstanding at June 30, 2002
    1,272,418       1,048,317  
 
Capital in excess of par value
    101,485,650       96,197,939  
 
Treasury stock, 845,277 shares at December 31, 2002 and June 30, 2002, at cost
    (1,277,613 )     (1,277,613 )
 
Accumulated deficit
    (92,087,856 )     (84,939,213 )
 
Accumulated other comprehensive income
    1,377,829       656,237  
 
Notes due from directors
    (50,912 )     (217,697 )
 
   
     
 
       
Total stockholders’ equity
    10,722,166       11,470,620  
   
 
   
     
 
 
  $ 20,568,879     $ 20,796,604  
 
   
     
 

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

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Table of Contents

VIRAGEN, INC. AND SUBSIDIARIES
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)

                       
          Six Months Ended
          December 31,
         
          2002   2001
         
 
OPERATING ACTIVITIES
               
 
Net loss
  $ (7,147,318 )   $ (5,601,402 )
 
Adjustments to reconcile net loss to net cash used in operating activities:
               
   
Depreciation and amortization
    423,931       336,298  
   
Amortization of intangible assets
    115,125       51,518  
   
Loss on sale of property, plant and equipment
    8,578        
   
Compensation expense on stock options and warrants
    (61,493 )     131,801  
   
Minority interest in loss of subsidiaries
    (661,761 )     (362,281 )
   
Amortization of discount on convertible debentures and promissory notes
    2,422,951        
   
Amortization of deferred financing costs
    144,037        
   
Income tax benefit
    (38,772 )      
 
Increase (decrease) relating to operating activities from:
               
   
Accounts receivable
    286,882       60,726  
   
Inventories
    (972,491 )     204,749  
   
Prepaid expenses
    66,424       166,787  
   
Other current assets
    826,978       179,556  
   
Deposit and other assets
          21,404  
   
Accounts payable
    726,597       (544,115 )
   
Accrued expenses and other liabilities
    (233,306 )     61,989  
   
Notes due from directors
    4,836       (3,549 )
 
   
     
 
     
Net cash used in operating activities
    (4,088,802 )     (5,296,519 )
INVESTING ACTIVITIES
               
 
Additions to property, plant and equipment
    (329,349 )     (219,556 )
 
Acquisition of ViraNative, net of cash acquired
          (165,627 )
 
   
     
 
     
Net cash used in investing activities
    (329,349 )     (385,183 )
FINANCING ACTIVITIES
               
 
Net proceeds from private placements
    2,735,523       332,199  
 
Net borrowings on lines of credit and short term promissory notes
    (325,626 )     46,171  
 
Payments on long-term debt
    (27,391 )     (34,138 )
 
Net proceeds from issuance of convertible debentures
    2,308,250        
 
Payments on convertible debentures
    (1,111,113 )      
 
Collections on notes due from directors
    50,000       50,000  
 
Proceeds from exercise of options and warrants
    14,433       238,238  
 
   
     
 
     
Net cash provided by financing activities
    3,644,076       632,470  
Effect of exchange rate fluctuations on cash
    40,167       (85,684 )
 
   
     
 
Decrease in cash and cash equivalents
    (733,908 )     (5,134,916 )
Cash and cash equivalents at beginning of period
    765,861       7,659,153  
 
 
   
     
 
Cash and cash equivalents at end of period
  $ 31,953     $ 2,524,237  
 
   
     
 

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

NOTE A – CONSOLIDATION AND BASIS OF PRESENTATION

     Viragen, Inc. and its subsidiaries are engaged in the research, development, manufacture and sale of certain immunological products for the treatment of life-threatening illnesses. We are also in the business of developing innovative technologies aimed at improving the manufacturing processes used to produce certain medical therapies.

     The accompanying unaudited 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. The consolidated condensed financial statements have been prepared in conformity with accounting principles generally accepted in the United States, which contemplate continuation of the Company as a going concern.

     As of December 31, 2002 and June 30, 2002 our ownership interest in Viragen International was approximately 72.8% and 70.2%, respectively. If ViraNative, a wholly-owned subsidiary of Viragen International acquired in September 2001, meets all of the milestones under the acquisition agreement, our ownership interest in Viragen International would be reduced to approximately 59.2% assuming additional Viragen International shares are not issued for any other purposes.

     The accompanying unaudited interim consolidated condensed financial statements for Viragen 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 prepared in accordance with accounting principles generally accepted in the United States have been condensed or omitted. The balance sheet at June 30, 2002 has been derived from the audited financial statements at that date. Certain amounts in prior year’s consolidated condensed financial statements have been reclassified to conform to the current year’s presentation. The reclassifications had no effect on previously reported results of operations.

     For the fiscal year ended June 30, 2002, the report of our independent auditors contains an explanatory paragraph indicating substantial doubt as to our ability to continue as a going concern, due to our financial condition. Our financial condition has not improved subsequent to our fiscal year end. If we are unable to raise additional debt or equity funding it will be necessary for us to significantly curtail or suspend a portion or all of our operations. No assurance can be given that additional funding will be available or if available, under what terms.

     During fiscal 2002, 2001 and 2000, we incurred significant losses of approximately $11,089,000, $11,008,000 and $12,311,000, respectively, and has an accumulated deficit of approximately $92,088,000 as of December 31, 2002. Additionally, we had a cash balance of approximately $32,000 and a working capital deficit of approximately $2,258,000 at December 31, 2002. Management anticipates additional future losses as it commercializes its natural human interferon product and conducts additional research activities and clinical trials to obtain additional regulatory approvals. Accordingly, we will require substantial additional funding. These factors, among others, raise substantial doubt about our ability to continue as a going concern. The accompanying consolidated condensed financial statements do not include any adjustments relating to the recoverability and classification of asset carrying amounts or the amount and classification of liabilities that might result from the outcome of these uncertainties.

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

NOTE B – INTERIM ADJUSTMENTS AND USE OF 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. Actual results could differ from those estimates. In the opinion of management, all adjustments, including normal recurring accruals, considered necessary for a fair presentation have been included.

     Operating results for the three and six months periods ended December 31, 2002 are not necessarily indicative of the results that may be expected for the fiscal year ended June 30, 2003.

     The 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 the Company’s Annual Report on Form 10-K for the year ended June 30, 2002, filed with the Securities and Exchange Commission.

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 human leukocyte interferon (alpha) product called Interferon Alfanative®. Subsequent to the acquisition, BioNative was renamed ViraNative and Interferon Alfanative was further developed into our new product, Multiferon®.

     The initial purchase consideration consisted of 2,933,190 shares of Viragen International common stock, which was valued at approximately $2.2 million based on the market price of Viragen International common stock at the date of the acquisition. In addition, Viragen International incurred approximately $204,000 in acquisition related costs. In January 2002, ViraNative received notification from the Medical Products Agency in Sweden that ViraNative’s Re-registration certificate was approved and as a second line treatment for any indication where patients did not respond to recombinant interferon. At that time, the former shareholders of ViraNative were issued an additional 8,799,570 shares of Viragen International common stock, which represented achievement of the first two milestones as defined in the acquisition agreement. The additional shares of Viragen International common stock were valued at approximately $6.6 million, based on the market price of Viragen International common stock at the time the milestones were achieved, all of which was allocated to goodwill.

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

NOTE C – ACQUISITION – (Continued)

     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.

     As each of these milestones is met, the additional shares of Viragen International will be issued, which will result in the recognition of additional intangible assets.

     The acquisition, completed on September 28, 2001, was accounted for as a purchase under Statement of Financial Accounting Standards No. 141 and, accordingly, the results of ViraNative’s operations are included in the Company’s consolidated results from the date of the acquisition.

NOTE D – GOODWILL AND OTHER INTANGIBLE ASSETS

     The goodwill reported in our balance sheets as of December 31, 2002 and June 30, 2002 arose from our acquisition of ViraNative in September 2001 and the subsequent achievement of certain milestones by ViraNative in January 2002 as discussed in Note C. In accordance with the provisions of SFAS No. 142, goodwill will not be amortized but will be reviewed for impairment on an annual basis or sooner if indicators of impairment arise. As of the date of these financial statements, we are not aware of any items or events that would cause us to adjust the recorded value of our goodwill for impairment. The following table reflects the changes in the carrying amount of goodwill for the six months ended December 31, 2002.

         
Balance as of June 30, 2002
  $ 8,460,940  
Goodwill acquired during the year
     
Foreign exchange adjustment
    426,504  
 
   
 
Balance as of December 31, 2002
  $ 8,887,444  
 
   
 

     The intangible assets reported in our balance sheets as of December 31, 2002 and June 30, 2002 arose from our acquisition of ViraNative in September 2001. As of December 31, 2002, intangible assets consist of the following:

                 
    Gross Carrying   Accumulated
    Amount   Amortization
   
 
Developed technology
  $ 1,958,294     $ (172,791 )
Customer contract
    132,927       (132,927 )
 
   
     
 
Total intangible assets
  $ 2,091,221     $ (305,718 )
 
   
     
 

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

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

     The developed technology consists of the production and purification methods developed by ViraNative. The 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 customer contract represented a purchase agreement with a customer that expired in December 2002 and accordingly this intangible asset was fully amortized at December 31, 2002. The estimated aggregate amortization expense for the fiscal year ended June 30, 2003 and the four succeeding fiscal years is as follows:

         
2003
  $ 182,000  
2004
    133,000  
2005
    133,000  
2006
    133,000  
2007
    133,000  

NOTE E – INVENTORIES

     Inventories are stated at the lower of cost or market (estimated net realizable value). Raw materials and supplies cost is determined on a first-in, first-out basis. Work in process and finished products costs consisting of materials, labor and overhead are recorded at a standard cost (which approximates actual cost). If the cost of the inventories exceeds their expected market value, provisions are recorded currently for the difference between the cost and the market value. These provisions are determined based on estimates. Finished products consist of purified human leukocyte interferon.

     Inventories consisted of the following at December 31, 2002 and June 30, 2002:

                 
    December 31,   June 30,
    2002   2002
   
 
Finished products
  $ 677,934     $ 410,343  
Work in process
    2,025,320       1,293,851  
Raw materials and supplies
    135,805       162,374  
 
   
     
 
Total inventories
  $ 2,839,059     $ 1,866,568  
 
   
     
 

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

NOTE F – DEBT

Lines of Credit and Short Term Borrowings

     On May 15, 2000, Viragen was approved for a $500,000 unsecured line of credit with a bank located in Florida. Interest is payable at the greater of 7.25% or the Prime Rate, as quoted by The Wall Street Journal and is adjustable daily. This unsecured line of credit was renewed on May 15, 2001, under the same terms, and remained unused until May 2002. The facility was renewed on May 15, 2002 and subsequently through January 15, 2003. There were no outstanding borrowings under this credit facility as of December 31, 2002 compared to $300,000 outstanding at June 30, 2002.

     Through Viragen International’s Swedish subsidiary, ViraNative, we may borrow up to approximately $960,000 under an overdraft facility with a bank in Sweden. Borrowings outstanding under this facility are at a floating rate of interest which was approximately 7.5% at December 31, 2002. The facility renews annually and was renewed in December 2002. Outstanding borrowings under this agreement totaled approximately $960,000 as of December 31, 2002. The overdraft facility is secured by certain assets of ViraNative including inventories and accounts receivable.

     During August 2002, Viragen obtained short term financing of approximately $31,000 for the purchase of certain corporate insurance policies. Outstanding borrowings under this arrangement bear interest at an effective rate of approximately 6.45%. Principal and interest payments of approximately $3,200 are payable monthly. The outstanding balance on this short term borrowing was approximately $19,000 as of December 31, 2002. The final payment on this short term borrowing will be in June 2003.

     During June 2002, Viragen obtained short term financing of approximately $183,000 for the purchase of certain corporate insurance policies. Outstanding borrowings under this arrangement bear interest at an effective rate of approximately 5.53%. Principal and interest payments of approximately $21,000 are payable monthly. The outstanding balance on this short term borrowing was approximately $62,000 as of December 31, 2002. The final payment on this short term borrowing will be in March 2003.

Long-Term Debt

     As of December 31, 2002, our long-term debt totaling approximately $1,103,000 consisted of a mortgage loan agreement with a Swedish bank and two other loan agreements with Swedish governmental agencies. Outstanding borrowings under these agreements bear interest at rates ranging from 5.35% to 11.4%.

     Long-term debt includes a 25-year mortgage obtained to purchase one of our facilities in Sweden. The outstanding principal balance on this loan was approximately $639,000 at December 31, 2002. This loan carries a floating rate of interest which was approximately 5.35% at December 31, 2002. We are required to make quarterly payments of principal and interest of approximately $7,000 under this agreement. This loan matures in September 2024 and is secured by the related land and building with a carrying value of approximately $766