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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 MARCH 31, 2004

 

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  ¨

 

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Securities Exchange Act of 1934).    Yes  ¨    No  x

 

As of May 7, 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 nine months ended March 31, 2004 and 2003

   3
     2 )  

Consolidated condensed balance sheets as of March 31, 2004 (unaudited) and June 30, 2003

   4
     3 )  

Consolidated condensed statements of cash flows (unaudited) for the nine months ended March 31, 2004 and 2003

   5
     4 )  

Notes to consolidated condensed financial statements (unaudited)

   6

Item 2.

   Management’s Discussion and Analysis of Financial Condition and Results of Operations    13

Item 3.

   Quantitative and Qualitative Disclosures About Market Risk    21

Item 4.

   Controls and Procedures    22

PART II - OTHER INFORMATION

   24

Item 6.

   Exhibits and Reports on Form 8-K    24

SIGNATURES

   25

 

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VIRAGEN INTERNATIONAL, INC. AND SUBSIDIARIES

CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS

(Unaudited)

 

    

Three Months Ended

March 31,


   

Nine Months Ended

March 31,


 
     2004

    2003

    2004

    2003

 

Product sales

   $ 76,678     $ 48,140     $ 188,325     $ 519,617  

Costs and expenses

                                

Cost of sales

     619,847       325,207       1,520,877       747,164  

Research and development

     363,019       274,128       1,016,315       741,178  

Selling, general and administrative

     1,109,303       881,826       2,895,475       2,599,951  

Amortization of intangible assets

     42,274       33,703       118,501       148,828  

Other expense (income), net

     14,919       (118,584 )     (241,047 )     (207,891 )

Interest expense

     42,080       45,871       126,355       144,409  
    


 


 


 


Loss before income taxes

     (2,114,764 )     (1,394,011 )     (5,248,151 )     (3,654,022 )

Income tax benefit

     10,957       10,957       32,871       49,729  
    


 


 


 


Net loss

   $ (2,103,807 )   $ (1,383,054 )   $ (5,215,280 )   $ (3,604,293 )
    


 


 


 


Loss per common share - basic and diluted

   $ (0.03 )   $ (0.03 )   $ (0.08 )   $ (0.08 )
    


 


 


 


Weighted average common shares - basic and diluted

     68,113,764       50,970,907       68,113,764       47,979,347  
    


 


 


 


 

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

 

    

March 31,

2004


   

June 30,

2003


 
     (Unaudited)        
ASSETS  

Current assets

                

Cash and cash equivalents

   $ 372,787     $ 264,224  

Accounts receivable

     42,934       105,334  

Inventories

     3,409,618       3,311,583  

Prepaid expenses

     265,673       173,254  

Other current assets

     287,630       61,184  
    


 


Total current assets

     4,378,642       3,915,579  

Property, plant and equipment

                

Land, building and improvements

     3,445,099       3,143,965  

Equipment and furniture

     4,675,306       4,625,543  

Construction in progress

     1,408,630       551,493  
    


 


       9,529,035       8,321,001  

Less accumulated depreciation

     (3,249,963 )     (2,708,844 )
    


 


       6,279,072       5,612,157  

Goodwill

     10,213,568       9,678,302  

Developed technology, net

     1,853,351       1,869,122  
    


 


     $ 22,724,633     $ 21,075,160  
    


 


LIABILITIES AND STOCKHOLDERS’ EQUITY  

Current liabilities

                

Accounts payable

   $ 755,740     $ 1,300,919  

Accrued expenses and other liabilities

     676,444       598,157  

Line of credit

     875,484       999,192  

Current portion of long-term debt

     122,924       60,421  
    


 


Total current liabilities

     2,430,592       2,958,689  

Long-term debt, less current portion

     1,101,719       1,124,335  

Advances from parent

     10,041,773       3,680,530  

Deferred income tax liability

     511,325       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 March 31, 2004 and June 30, 2003

     681,138       681,138  

Additional paid-in capital

     45,537,903       45,537,903  

Accumulated deficit

     (41,166,531 )     (35,951,251 )

Accumulated other comprehensive income

     3,586,714       2,499,620  
    


 


Total stockholders’ equity

     8,639,224       12,767,410  
    


 


     $ 22,724,633     $ 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)

 

    

Nine Months Ended

March 31,


 
     2004

    2003

 

OPERATING ACTIVITIES

                

Net loss

   $ (5,215,280 )   $ (3,604,293 )

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

                

Depreciation

     560,921       529,158  

Amortization of intangible assets

     118,501       148,828  

Loss on disposition of property, plant, and equipment

     117,179       8,578  

Deferred income tax benefit

     (32,871 )     (49,729 )

Increase (decrease) relating to operating activities from:

                

Accounts receivable

     62,400       312,909  

Inventories

     (98,035 )     (1,293,550 )

Prepaid expenses and other current assets

     (198,121 )     650,000  

Accounts payable and accrued expenses

     (566,656 )     1,129,522  
    


 


Net cash used in operating activities

     (5,251,962 )     (2,168,577 )

INVESTING ACTIVITIES

                

Additions to property, plant and equipment

     (948,059 )     (335,191 )

Proceeds from sale of property, plant and equipment

     35,783       —    
    


 


Net cash used in investing activities

     (912,276 )     (335,191 )

FINANCING ACTIVITIES

                

Advances from parent

     6,361,243       2,334,664  

Net (payment) borrowing on line of credit

     (178,003 )     101,725  

Net payment on long-term debt

     (26,475 )     (52,494 )
    


 


Net cash provided by financing activities

     6,156,765       2,383,895  

Effect of exchange rate fluctuations on cash

     116,036       83,022  
    


 


Increase (decrease) in cash and cash equivalents

     108,563       (36,851 )

Cash and cash equivalents at beginning of period

     264,224       77,405  
    


 


Cash and cash equivalents at end of period

   $ 372,787     $ 40,554  
    


 


 

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 March 31, 2004, 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, located in Umeå, Sweden and Viragen (Scotland) Limited, 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 nine month periods ended March 31, 2004 are not necessarily indicative of the results that may be expected for the fiscal year ending June 30, 2004.

 

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Table of Contents

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

 

During the three and nine months ended March 31, 2004 we incurred losses of approximately $2,104,000 and $5,215,000, 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 $41,167,000 as of March 31, 2004. 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 $373,000 and working capital of approximately $1,948,000 at March 31, 2004. 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 at least March 31, 2005. Viragen will be required to raise additional funds to support our operations. 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

March 31,


   

Nine Months Ended

March 31,


 
     2004

    2003

    2004

    2003

 

Net loss as reported

   $ (2,103,807 )   $ (1,383,054 )   $ (5,215,280 )   $ (3,604,293 )

Stock based compensation determined under the fair value method

     (1,578 )     (6,806 )     (9,941 )     (29,025 )
    


 


 


 


Pro forma net loss

   $ (2,105,385 )   $ (1,389,860 )   $ (5,225,221 )   $ (3,633,318 )
    


 


 


 


Loss per common share:

                                

Basic and diluted – as reported

   $ (0.03 )   $ (0.03 )   $ (0.08 )   $ (0.08 )

Basic and diluted – pro forma

   $ (0.03 )   $ (0.03 )   $ (0.08 )   $ (0.08 )

 

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Table of Contents

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 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.

 

NOTE D – GOODWILL AND OTHER INTANGIBLE ASSETS

 

The goodwill reported in our balance sheets as of March 31, 2004 and June 30, 2003 arose from our 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 $2,626,000 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 nine months ended March 31, 2004:

 

Balance as of June 30, 2003

   $ 9,678,302

Foreign exchange adjustment

     535,266
    

Balance as of March 31, 2004

   $ 10,213,568
    

 

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 March 31, 2004, 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 the shares of our 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.

 

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Table of Contents

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

 

The developed technology intangible asset reported in our balance sheets as of March 31, 2004 and June 30, 2003 arose from our acquisition of ViraNative on September 28, 2001. A detail of our developed technology intangible asset as of March 31, 2004 and June 30, 2003 is as follows:

 

     March 31,
2004


    June 30,
2003


 

Developed technology, gross

   $ 2,250,498     $ 2,132,555  

Accumulated amortization

     (397,147 )     (263,433 )
    


 


Developed technology, net

   $ 1,853,351     $ 1,869,122  
    


 


 

Our 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 $600,000 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.

 

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

 

2004

   $ 159,000

2005

     163,000

2006

     163,000

2007

     163,000

2008

     163,000

 

Our intangible assets were pledged as collateral in connection with a series of convertible debentures issued by Viragen. These debentures were issued from January 2003 through June 2003 totaling approximately $11.8 million. As of December 31, 2003, there was no principal balance outstanding on these convertible debentures. Viragen satisfied the obligation either by payment of the outstanding debentures or through the issuance of shares of Viragen common stock upon conversion of the debentures.

 

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Table of Contents

NOTE E – INVENTORIES

 

Inventories consist of raw materials and supplies, work in process, and finished product. Finished product consists of purified natural human alpha interferon. Finished product and work in process costs consisting of materials, labor and overhead are recorded at a standard cost (which approximates actual cost). Raw materials and supplies cost is determined on a first-in, first-out basis. Our inventories are stated at the lower of cost or market (estimated net realizable value). 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.

 

Inventories consisted of the following at March 31, 2004 and June 30, 2003:

 

     March 31,
2004


   June 30,
2003


Finished product

   $ 1,048,723    $ 845,836

Work in process

     2,158,873      2,307,499

Raw materials and supplies

     202,022      158,248
    

  

Total inventories

   $ 3,409,618    $ 3,311,583
    

  

 

Certain raw materials used in the manufacture of our natural human alpha interferon product are available from a limited number of suppliers. We are dependent on our suppliers to allocate a sufficient portion of their capacity to meet our needs.

 

NOTE F – DEBT

 

Line of Credit

 

Through our Swedish subsidiary, ViraNative, we may borrow up to approximately $1,104,000 under an overdraft facility with a bank in Sweden. Borrowings outstanding under this facility are at a floating rate of interest, which was approximately 7.4% at March 31, 2004. The facility renews annually and was renewed in December 2003. Outstanding borrowings under this agreement totaled approximately $875,000 and $999,000 as of March 31, 2004 and June 30, 2003, respectively. The overdraft facility is secured by certain assets of ViraNative including inventories and accounts receivable.

 

Long-Term Debt

 

Long-term debt includes a 25-year mortgage with a Swedish bank obtained to purchase one of our facilities in Sweden. The outstanding principal balance on this loan was approximately $692,000 and $680,000 at March 31, 2004 and June 30, 2003, respectively. This loan carries a floating rate of interest which was approximately 5.25% at March 31, 2004. We are required to make quarterly payments of principal and interest of approximately $9,000 under this agreement. This loan matures in September 2024 and is secured by the related land and building with a carrying value of approximately $880,000 as of March 31, 2004.

 

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Table of Contents

NOTE F – DEBT – (Continued)

 

Under the terms of a loan with a Swedish governmental agency that was obtained for the purposes of conducting clinical trials, we are required to make quarterly payments of principal and interest of approximately $30,000. The loan carries a floating rate of interest at the Stockholm Interbank Offered Rate (STIBOR) 90 plus 7%, which was approximately 9.90% as of March 31, 2004. This loan had an outstanding balance of approximately $532,000 and $505,000 at March 31, 2004 and June 30, 2003, respectively.

 

NOTE G – ROYALTY AGREEMENT

 

Viragen, Inc., our parent company, and Medicore, Inc. entered into a royalty agreement with respect to interferon, transfer factor and products using interferon and transfer factor in November 1986. The agreement was subsequently amended in November 1989 and May 1993. The amended agreement provides for a maximum cap on royalties to be paid to Medicore of $2,400,000. It includes a schedule of royalty payments of:

 

  5% of the first $7,000,000 of sales,

 

  4% of the next $10,000,000, and

 

  3% of the next $55,000,000

 

These royalties are to be paid until the total of $2,400,000 is achieved. The amended agreement also states that royalties of approximately $108,000 previously accrued by Viragen, Inc. prior to May 1993 under the agreement are payable to Medicore as the final payment. From May 1993 through September 2001, Viragen, Inc. paid royalties under the amended agreement totaling approximately $70,000.

 

Royalties owed to Medicore based on our natural human alpha interferon sales from October 1, 2001 through June 30, 2003 are payable as follows: $30,000 by August 1, 2003; $30,000 by August 1, 2004; $30,000 by August 1, 2005. The payment of $30,000 due August 1, 2003 has been made. We will pay royalties to Medicore based on the sale of our natural human alpha interferon subsequent to June 30, 2003 on a quarterly basis in accordance with the terms of the amended agreement. For the three and nine months ended March 31, 2004, royalties due under the agreement totaled approximately $3,700 and $9,400, respectively.

 

NOTE H – COMPREHENSIVE LOSS

 

Comprehensive loss is comprised of our net loss and other comprehensive (loss) income. Other comprehensive (loss) income refers to revenue, expenses, gains and losses that under accounting principles generally accepted in the United States are included in comprehensive loss but are excluded from net loss as these amounts are recorded directly as an adjustment to stockholders’ equity. Our other comprehensive (loss) income is composed of foreign currency translation adjustments. The following table sets forth the computation of comprehensive loss for the periods indicated:

 

    

Three Months Ended

March 31,


   

Nine Months Ended

March 31,


 
     2004

    2003

    2004

    2003

 

Net loss

   $ (2,103,807 )   $ (1,383,054 )   $ (5,215,280 )   $ (3,604,293 )

Other comprehensive (loss) income:

                                

Currency translation adjustment

     (632,517 )     243,170       1,087,094       964,762  
    


 


 


 


Comprehensive loss

   $ (2,736,324 )   $ (1,139,884 )   $ (4,128,186 )   $ (2,639,531 )
    


 


 


 


 

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Table of Contents

NOTE I – TRANSACTIONS WITH PARENT

 

Viragen provides certain administrative services to us including management and general corporate assistance. Viragen also incurs certain costs attributable to us including insurance and rent. These expenses are charged on the basis of direct usage, when identifiable, or on the basis of time spent. Management believes that the expenses allocated to Viragen International are representative of the operating expenses incurred by Viragen on our behalf. However, the financial information included herein may not reflect the consolidated financial statements of Viragen International had we operated as a separate stand-alone entity during the periods presented. For the three and nine months ended March 31, 2004, expenses allocated by Viragen totaled approximately $234,000 and $681,000, respectively, compared to approximately $216,000 and $688,000 for the three and nine months ended March 31, 2003, respectively.

 

In January, February, April, May, and June 2003, Viragen International, its subsidiaries and all wholly-owned subsidiaries of Viragen executed guarantee and security agreements collateralizing a series of convertible debentures issued by Viragen totaling approximately $11.8 million. The guarantee and security agreements covered all assets, including tangible and intangible assets not otherwise pledged, of Viragen and its subsidiaries, including Viragen International. As of December 31, 2003, there was no principal balance outstanding on these convertible debentures. Viragen satisfied the obligation either by payment of the outstanding debentures or through the issuance of shares of Viragen common stock upon conversion of the debentures.

 

NOTE J – RECENT ACCOUNTING PRONOUNCEMENTS

 

In January 2003, FASB issued Interpretation Number 46, Consolidation of Variable Interest Entities (FIN No. 46). This interpretation of Accounting Research Bulletin No. 51, Consolidated Financial Statements, provides guidance for identifying a controlling interest in a variable interest entity established by means other than voting interests. FIN No. 46 also requires consolidation of a variable interest entity by an enterprise that holds such a controlling interest. In December 2003, the FASB completed its deliberations regarding the proposed modification to FIN No. 46 and issued Interpretation Number 46R, Consolidation of Variable Interest Entities – an Interpretation of ARB No. 51 (FIN No. 46R). The decisions reached included a deferral of the effective date and provisions for additional scope exceptions for certain types of variable interests. Application of FIN No. 46R is required in financial statements of public entities that have interests in variable interest entities or potential variable interest entities commonly referred to as special-purpose entities for periods ending after December 15, 2003. Application by public entities (other than small business issuers) for all other types of entities is required in financial statements for periods ending after March 15, 2004. Adoption of FIN No. 46R 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.

 

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

Introduction

 

Cautionary Factors That May Affect Future Results

 

This document and other documents we may file with the Securities and Exchange Commission contain forward-looking statements. Also our company management may make forward-looking statements orally to investors, analysts, the media and others.

 

Forward-looking statements express our expectations or predictions of future events or results. They are not guarantees and are subject to many risks and uncertainties. There are a number of factors—many beyond our control—that could cause actual events or results to be significantly different from those described in the forward-looking statement. Any or all of our forward-looking statements in this report or in any other public statements we make may turn out to be wrong.

 

Forward-looking statements might include one or more of the following:

 

  anticipated debt or equity fundings;

 

  projections of future revenue;

 

  anticipated clinical trial commencement dates, completion timelines or results;

 

  anticipated receipt of regulatory approvals;

 

  descriptions of plans or objectives of management for future operations, products or services;

 

  forecasts of future economic performance; and

 

  descriptions or assumptions underlying or relating to any of the above items.

 

Forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts. They use words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or words of similar meaning. They may also use words such as “will,” “would,” “should,” “could” or “may.”

 

Factors that may cause actual results to differ materially include the risks and uncertainties discussed below, as well as in the “Risk Factors” section included in our Prospectus (File No. 333-75998) filed on November 22, 2002 with the Securities and Exchange Commission pursuant to Rule 424 (b) (3) of the Securities Act of 1933. You should read them. You should also read the risk factors listed from time to time in our reports on Forms 10-Q or 10-K and registration statements and amendments, if any. We will provide you with a copy of any or all of these documents at no charge.

 

Our business, results of operations and financial condition could be adversely affected by a number of risks and uncertainties, including the following:

 

  whether we are able to secure sufficient funding to maintain our operations, complete clinical trials, and successfully market our product;

 

  whether the efficacy, production, price and timing of our natural human alpha interferon will enable us to compete with other well established, highly capitalized, biopharmaceutical companies;

 

  whether our patent applications result in the issuance of patents, or whether patents and other intellectual property rights provide adequate protections in the event of misappropriation or infringement by third parties;

 

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  whether clinical testing confirms the efficacy of our product, and results in the receipt of regulatory approvals. We have not sought the approval of our natural human alpha interferon product from the U.S. Food and Drug Administration or its European Union counterparts, except Sweden;

 

  whether, despite achievement of regulatory approvals, our products are accepted as a treatment superior to that of our competitors; and

 

  whether we can generate revenue sufficient to offset our historical losses and achieve profitability.

 

Our natural human alpha interferon product was developed and is manufactured overseas in our Swedish facility. Our dependence on foreign manufacturing and expected international sales exposes us to a number of risks, including:

 

  unexpected changes in regulatory requirements;

 

  tariffs and other trade barriers, including import and export restrictions;

 

  political or economic instability;

 

  compliance with foreign laws;

 

  transportation delays and interruptions;

 

  difficulties in protecting intellectual property rights in foreign countries; and

 

  currency exchange risks.

 

Recent Developments

 

In March 2004, we filed a patent application in the United States covering the use of our natural human alpha interferon for the treatment and prevention of severe acute respiratory syndrome (SARS). This represents our third patent application related to the SARS indication.

 

In February 2004, Viragen filed a patent application with the British Patent Office covering the use of natural, multi-subtype alpha interferon for human treatment and prevention of avian influenza virus, commonly known as avian flu. Avian influenza is an infectious viral disease of birds caused by type A influenza strain. The type A influenza group of viruses has certain characteristics that make them of particular concern to the human population. They have a tendency to undergo mutation, resulting in new variants for which no vaccine is available. In addition, such viruses have the potential to combine with viruses from other species, leading to pandemics due to the resulting difficulties in developing effective treatments or preventative measures. While no studies are currently planned or ongoing, we believe that Multiferon is a prime candidate for evaluation in avian influenza studies. We are contacting those international research organizations which are conducting studies in this area and offering samples of our product for in vitro and human evaluations.

 

Critical Accounting Policies

 

Our discussion and analysis of our financial condition and results of operations is based upon our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses. On an on-going basis, we evaluate our estimates, including those related to inventories, depreciation, amortization, asset valuation allowances, contingencies and litigation. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We believe that the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our financial statements.

 

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  Inventories. Inventories consist of raw materials and supplies, work in process and finished product. Finished product consists of purified natural human alpha interferon. Our 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 product costs consisting of raw materials, labor and overhead are recorded at a standard cost (which approximates actual cost). Excess/idle capacity costs are expensed in the period in which they are incurred. 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. The valuation of inventories also requires us to estimate excess inventories and inventories that are not saleable. The determination of excess or non-saleable inventories requires us to estimate the future demand for our product and consider the shelf life of the inventory. If actual demand is less than our estimated demand, we could be required to record inventory reserves, which would have an adverse impact on our results of operations.

 

  Long-lived assets. In accordance with SFAS No. 144, Accounting for the Impairment or Disposal of Long-Lived Assets, we review our long-lived assets, including intangible assets, for impairment whenever events or changes in circumstances indicate that the carrying amount of these assets may not be fully recoverable. The assessment of possible impairment is based on our ability to recover the carrying value of our asset based on our estimate of its undiscounted future cash flows. If these estimated future cash flows are less than the carrying value of the asset, an impairment charge is recognized for the difference between the asset’s estimated fair value and its carrying value. 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 long-lived assets, including intangible assets, for impairment.

 

  Goodwill. In accordance with SFAS No. 142, Goodwill and Other Intangible Assets, goodwill is not amortized. Goodwill is reviewed for impairment on an annual basis or sooner if indicators of impairment arise. All of our goodwill arose from the acquisition of ViraNative in September 2001 and the subsequent achievement of certain milestones defined in the acquisition agreement. We periodically evaluate that acquired business for potential impairment indicators. Our judgments regarding the existence of impairment indicators are based on legal factors, market conditions, and the operational performance of the acquired business. During the fourth quarter of fiscal 2003, we completed our annual impairment review of our goodwill with the assistance of an independent valuation firm. The impairment review indicated that our goodwill was not impaired. Future changes in the estimates used to conduct the impairment review, including revenue projections or the fair market value of the shares of our 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. Our next annual impairment review will occur during the fourth quarter of fiscal 2004.

 

  Revenue recognition. We recognize revenue from sales of our natural human alpha interferon product when title and risk of loss has been transferred, which is generally upon shipment. Moreover, recognition requires persuasive evidence that an arrangement exists, the price is fixed and determinable, and collectibility is reasonably assured.

 

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Liquidity and Capital Resources

 

We are currently dependent upon revenue generated from the sale of our natural human alpha interferon product and advances by Viragen, Inc., our parent company, to fund our operations. Our operating losses and working capital requirements continue to adversely affect cash flow. Historically, Viragen 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 at least March 31, 2005. Viragen will be required to raise additional funds to support our operations. No assurance can be given that additional capital will be available when required or upon terms acceptable to Viragen.

 

For the nine months ended March 31, 2004, our funding consisted of revenue generated from the sale of our natural human alpha interferon product totaling approximately $188,000 and advances from our parent company totaling approximately $6,361,000. At March 31, 2004, cash on hand totaled approximately $373,000 and working capital totaled approximately $1,948,000, an increase of approximately $991,000 when compared to working capital of approximately $957,000 as of June 30, 2003. Cash used to fund operations during the nine months ended March 31, 2004 totaled approximately $5,252,000, which included the reduction in our accounts payable and other accrued expenses balance of approximately $567,000 since June 30, 2003. During the nine months ended March 31, 2004, we also had capital expenditures totaling approximately $948,000, primarily for the build-out of our production facility in Sweden.

 

Our future capital requirements are dependent upon many factors, including: revenue generated from the sale of our natural human alpha interferon product; progress with future and ongoing clinical trials; the costs associated with obtaining regulatory approvals; the costs involved in patent applications; competing technologies and market developments; and our ability to establish collaborative arrangements and effective commercialization activities. For fiscal 2004, we anticipate the need of approximately $7.0 million for operating activities, $1.5 million for investing activities and $0.2 million to service our financing obligations.

 

Manufacturing of our natural human alpha interferon at our leased facility in Umea, Sweden, has been suspended since March 31, 2003. This planned break in routine manufacturing was necessary to allow for certain steps of the production process to be segregated and transferred to our owned facility which is also located in Umea, Sweden, which is in the process of being renovated. Renovation of this facility commenced in 2003 and is in line with our plan to expand our productive capacity of our natural human alpha interferon. The estimated total cost of this initial phase is $1.5 million and it is scheduled to be completed during 2004. As of March 31, 2004, we have invested approximately $832,000 on the renovation of this facility and the project is proceeding according to plan. We believe that our current inventory levels are sufficient to meet our current sales forecasts during the period in which routine production is planned to be suspended. We plan to expand the use of our owned facility in phases based on product demand and available financing. Maximum expansion, if warranted, could cost up to an additional $10 million.

 

We believe that our natural human alpha interferon product can be manufactured in sufficient quantity and be priced at a level to offer patients an attractive alternative treatment to the synthetic interferons currently being marketed. However, we can not assure you of the success of our commercialization efforts and other projects. Required regulatory approvals are subject to the successful completion of lengthy and costly clinical trials. The successful commercialization of Multiferon and the completion of required clinical trials and facility expansions depend on our ability to raise significant additional funding.

 

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Off Balance Sheet Arrangements

 

As of the date of this quarterly report, we do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors. The term “off-balance sheet arrangement” generally means any transaction, agreement or other contractual arrangement involving an unconsolidated entity, under which we have (i) any obligation arising under a guarantee contract, derivative instrument or variable interest; or (ii) a retained or contingent interest in assets transferred to an unconsolidated entity or similar arrangement that serves as credit, liquidity or market risk support for such assets.

 

Results of Operations

 

Product sales

 

For the three months ended March 31, 2004, product sales totaled approximately $77,000 compared to product sales of approximately $48,000 for the three months ended March 31, 2003. This increase in product sales of approximately $29,000 for the three months ended March 31, 2004 is primarily attributed to sales of our natural human alpha interferon product in Indonesia totaling approximately $31,000 with no corresponding sales during the quarter ended March 31, 2003.

 

For the nine months ended March 31, 2004, product sales totaled approximately $188,000 compared to approximately $520,000 for the nine months ended March 31, 2003. The decrease in product sales of approximately $332,000 for the nine months ended March 31, 2004 is primarily attributed to the absence of sales of bulk interferon product to Alfa Wasserman under a contractual arrangement which expired in December 2002. For the nine months ended March 31, 2003, sales to Alfa Wasserman totaled approximately $378,000.

 

During 2002 and 2003, we entered into several agreements for the distribution of our natural human alpha interferon, Multiferon, in various countries. To date, we have not recognized revenue from many of these agreements. The majority of these agreements require that the distributor obtain the necessary regulatory approvals, which are yet to be obtained. Regulatory approval is a mandatory step in the marketing of a drug, but it is by no means the final challenge in marketing a biopharmaceutical product. Multiferon is a critical care product that is typically administered in a hospital setting. Therefore, in certain instances, it must be part of a hospital’s approved formulary to enable physicians to be able to prescribe the product. This may include becoming approved within a nationalized network of hospitals. Also, the physicians must be educated as to the potential merits and advantages of the product.

 

There are other challenges associated with international marketing activities including: language and cultural barriers, poorly organized regulatory infrastructure and/or compliance, performance of assigned distributors, government’s willingness to promote cheaper generic products and the general population’s inability to afford private care drug products. It may take significant time to overcome these challenges with no assurance that a particular market will ever be effectively penetrated.

 

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Cost of Sales

 

Cost of sales and excess/idle production costs totaled approximately $620,000 and $1,521,000 for the three and nine months ended March 31, 2004, respectively. The increases in cost of sales of approximately $295,000 and $774,000 for the three and nine months ended March 31, 2004, respectively, and the resulting negative margins are attributed to excess/idle capacity costs. Excess/idle capacity costs represent fixed production costs incurred at our Swedish manufacturing facility, which were not absorbed as a result of the suspension of routine manufacturing as of March 31, 2003. This planned break in routine manufacturing was necessary to allow for certain steps of our production process to be segregated and transferred to our owned facility also located in Umea, Sweden, which is currently being renovated. We will continue to incur excess/idle production costs until we resume production at normal operating levels that absorb our fixed production costs.

 

Research and Development Costs

 

Research and development costs include scientific salaries and support fees, laboratory supplies, consulting fees, equipment rentals, repairs and maintenance, utilities and research related travel. Research and development costs for the three months ended March 31, 2004 totaled approximately $363,000, an increase of approximately $89,000 when compared to the three months ended March 31, 2003. For the nine months ended March 31, 2004, research and development costs totaled approximately $1,016,000, an increase of approximately $275,000 when compared to the nine months ended March 31, 2003. These increases in research and development costs were primarily attributed to costs incurred in the development of potential commercial applications of our natural human alpha interferon product at our Scottish facility totaling approximately $96,000 and $199,000 for the three and nine months ended March 31, 2004, respectively. These costs were mainly related to laboratory supplies, personnel related expenses and repairs and maintenance.

 

We will continue incurring research and development costs for additional clinical trial projects associated with Multiferon as well as other projects to more fully develop potential commercial applications of our natural human alpha interferon product and related technologies. Our ability to successfully conclude additional clinical trials, a prerequisite for expanded commercialization of any product, is dependent upon Viragen’s continued funding of our operations, our ability to independently raise significant additional funding, or our ability to generate sufficient cash flow from operations.

 

Selling, General and Administrative Expenses

 

Selling, general and administrative expenses include administrative personnel salaries and related expenses, office and equipment leases, utilities, insurance, legal, accounting, consulting, depreciation and amortization. Selling, general and administrative expenses totaled approximately $1,109,000 for the three months ended March 31, 2004 compared to approximately $882,000 for the three months ended March 31, 2003, representing an increase of approximately $227,000. This increase is attributed primarily to personnel-related termination costs at our Swedish subsidiary totaling approximately $238,000. For the three months ended March 31, 2004, selling, general and administrative expenses allocated by Viragen, our parent company, totaled approximately $234,000 compared to approximately $216,000 for the three months ended March 31, 2003.

 

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For the nine months ended March 31, 2004, selling, general and administrative expenses totaled approximately $2,895,000, an increase of approximately $296,000 when compared to the nine months ended March 31, 2003. This increase is attributed mainly to personnel-related termination costs at our Swedish subsidiary totaling approximately $238,000. For the nine months ended March 31, 2004, selling, general and administrative expenses allocated by Viragen, our parent company, totaled approximately $681,000 compared to approximately $688,000 for the nine months ended March 31, 2003.

 

Our successful commercialization of Multiferon will require additional marketing and promotional activities which is dependent upon Viragen’s continued funding of our operations, our ability to independently raise significant additional funding, or our ability to generate sufficient cash flow from operations.

 

Amortization of Intangible Assets

 

Amortization of intangible assets includes the amortization of the purchase price allocated to separately identified intangible assets obtained in the acquisition of ViraNative in September 2001. The separately identified intangible assets consist of developed technology and a customer contract. The developed technology is being amortized over its estimated useful life of approximately 14 years. The customer contract was amortized over the term of the contract, which expired in December 2002. For the three and nine months ended March 31, 2004, amortization of intangible assets totaled approximately $42,000 and $119,000, respectively, compared to approximately $34,000 and $149,000 during the three and nine months ended March 31, 2004. The decrease of approximately $30,000 for the nine months ended March 31, 2004 is primarily the result of the acquired customer contract being fully amortized as of December 2002.

 

Other Expense (Income), Net

 

The primary components of other expense (income) are interest earned on cash and cash equivalents, sublease income on certain office space in our facility in Scotland, transaction gains or losses on foreign exchange, gains or losses on the disposal of property and equipment, and income generated from research and development support services provided by our Swedish subsidiary. For the three months ended March 31, 2004, other expense totaled approximately $15,000 compared to other income of approximately $119,000 for the three months ended March 31, 2003. The decrease in other income for the three months ended March 31, 2004 totaling approximately $134,000 is mainly attributed to losses on the disposition of property, plant and equipment at our Scottish subsidiary totaling approximately $100,000.

 

For the nine months ended March 31, 2004, other income totaled approximately $241,000 or an increase of approximately $33,000 when compared to the nine months ended March 31, 2003. This increase in other income is mainly attributed to an increase in income generated from research and development support services provided by our Swedish subsidiary totaling approximately $117,000 and an increase in sublease income at our Scottish facility totaling approximately $42,000. These increases in other income were offset in part by losses on the disposition of property, plant and equipment at our Scottish subsidiary totaling approximately $117,000.

 

Interest Expense

 

Interest expense for the three and nine months ended March 31, 2004 totaled approximately $42,000 and $126,000, respectively, compared to interest expense totaling approximately $46,000 and $144,000 for three and nine months ended March 31, 2003, respectively. This interest expense primarily represents interest incurred on the debt facilities maintained by our Swedish subsidiary. These credit facilities have interest rates ranging from 5.25% to 9.90%.

 

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Income Tax Benefit

 

We are subject to tax in the United States, Sweden, and the United Kingdom. These jurisdictions have different marginal tax rates. For the nine months ended March 31, 2004 and March 31, 2003, income tax benefit totaled approximately $33,000 and $50,000, respectively. Income tax benefit for these periods is primarily related to the amortization expense on certain intangible assets. Due to the treatment of the identifiable intangible assets under Statement of Financial Accounting Standards (SFAS) No. 109, Accounting for Income Taxes, our balance sheet reflects a deferred tax liability of approximately $511,000 as of March 31, 2004, all of which is related to our developed technology intangible asset acquired on September 28, 2001.

 

Based on our accumulated losses, a full valuation allowance is provided to reduce deferred tax assets to the amount that will more likely than not be realized.

 

Recent Accounting Pronouncements

 

In January 2003, FASB issued Interpretation Number 46, Consolidation of Variable Interest Entities (FIN No. 46). This interpretation of Accounting Research Bulletin No. 51, Consolidated Financial Statements, provides guidance for identifying a controlling interest in a variable interest entity established by means other than voting interests. FIN No. 46 also requires consolidation of a variable interest entity by an enterprise that holds such a controlling interest. In December 2003, the FASB completed its deliberations regarding the proposed modification to FIN No. 46 and issued Interpretation Number 46R, Consolidation of Variable Interest Entities – an Interpretation of ARB No. 51 (FIN No. 46R). The decisions reached included a deferral of the effective date and provisions for additional scope exceptions for certain types of variable interests. Application of FIN No. 46R is required in financial statements of public entities that have interests in variable interest entities or potential variable interest entities commonly referred to as special-purpose entities for periods ending after December 15, 2003. Application by public entities (other than small business issuers) for all other types of entities is required in financial statements for periods ending after March 15, 2004. Adoption of FIN No. 46R 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.

 

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Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

Market risk generally represents the risk of loss that may result from the potential change in value of a financial instrument as a result of fluctuations in interest rates and market prices. We have not traded or otherwise transacted in derivatives nor do we expect to do so in the future. We have established policies and internal processes related to the management of market risks which we use in the normal course of our business operations.

 

Interest Rate Risk

 

The fair value of long-term debt is subject to interest rate risk. While changes in market interest rates may affect the fair value of our fixed-rate long-term debt, we believe a change in interest rates would not have a material impact on our financial condition, future results of operations or cash flows.

 

Foreign Currency Exchange Risk

 

We conduct operations in several different countries. The balance sheet accounts of our operations in Scotland and Sweden are translated to U.S. dollars for financial reporting purposes and resulting adjustments are made to stockholders’ equity. The value of the respective local currency may strengthen or weaken against the U.S. dollar, which would impact the value of stockholders’ investment in our common stock. Fluctuations in the value of the British Pound and Swedish Krona against the U.S. dollar have occurred during our history, which have resulted in unrealized foreign currency translation gains and losses, which are included in accumulated other comprehensive income and shown in the equity section of our balance sheet.

 

While most of the transactions of our U.S. and foreign operations are denominated in the respective local currency, some transactions are denominated in other currencies. Since the accounting records of our foreign operations are kept in the respective local currency, any transactions denominated in other currencies are accounted for in the respective local currency at the time of the transaction. Upon settlement of this type of transaction, any foreign currency gain or loss results in an adjustment to income.

 

Our results of operations may be impacted by the fluctuating exchange rates of foreign currencies, especially the British Pound and Swedish Krona, in relation to the U.S. dollar. Most of the revenue and expense items of our foreign subsidiaries are denominated in the respective local currency. An unfavorable change in the exchange rate of the foreign currency against the U.S. dollar will result in lower revenue when translated into U.S. dollars. Operating expenses would also be lower in these circumstances.

 

During the nine months ended March 31, 2004, the U.S. dollar has experienced adverse fluctuations against the British Pound and the Swedish Krona. Based on the foreign currency exchange rates as of March 31, 2004, the U.S. dollar has lost approximately 10.66% and 5.53% of its value against the British Pound and Swedish Krona, respectively, since June 30, 2003. The weakening of the U.S. dollar has resulted in greater revenues, operating expenses, assets and liabilities of our foreign subsidiaries when translated to U.S. dollars.

 

We do not currently engage in hedging activities with respect to our foreign currency exposure. However, we continually monitor our exposure to currency fluctuations. We have not incurred significant realized losses on exchange transactions. If realized losses on foreign transactions were to become significant, we would evaluate appropriate strategies, including the possible use of foreign exchange contracts, to reduce such losses.

 

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We were not adversely impacted by the European Union’s adoption of the “Euro” currency. Our foreign operations to date have been located in Scotland and Sweden which have not participated in the adoption of the Euro as of March 31, 2004.

 

Item 4. Controls and Procedures

 

Quarterly Controls Evaluation and Related CEO and CFO Certifications

 

We conducted an evaluation of the effectiveness of the design and operation of our “disclosure controls and procedures” (Disclosure Controls) as of the end of the period covered by this Quarterly Report. The controls evaluation was done under the supervision and with the participation of management, including our Chief Executive Officer (CEO) and Chief Financial Officer (CFO).

 

Attached as exhibits to this Quarterly Report are certifications of the CEO and the CFO, which are required in accord with Rule 13a-14 of the Exchange Act. This Controls and Procedures section includes the information concerning the controls evaluation referred to in the certifications and it should be read in conjunction with the certifications for a more complete understanding of the topics presented.

 

Definition of Disclosure Controls

 

Disclosure Controls are controls and procedures designed to reasonably assure that information required to be disclosed in our reports filed under the Exchange Act, such as this Quarterly Report, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure Controls are also designed to reasonably assure that such information is accumulated and communicated to our management, including the CEO and CFO, as appropriate to allow timely decisions regarding required disclosure. Our Disclosure Controls include components of our internal control over financial reporting, which consists of control processes designed to provide reasonable assurance regarding the reliability of our financial reporting and the preparation of financial statements in accordance with accounting principles generally accepted in the United States.

 

Limitations on the Effectiveness of Controls

 

Our management, including the CEO and CFO, does not expect that our Disclosure Controls or our internal control over financial reporting will prevent all error and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. The design of any system of controls is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

 

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Conclusions

 

Based upon the controls evaluation, our CEO and CFO have concluded that, subject to the limitations noted above, as of the end of the period covered by this Quarterly Report, our Disclosure Controls were effective to provide reasonable assurance that material information relating to Viragen International and its consolidated subsidiaries is made known to management, including the CEO and CFO, as appropriate to allow timely decisions regarding required disclosure.

 

Changes in Internal Control over Financial Reporting

 

There has been no change in our internal control over financial reporting (as defined in Rules 13a-15(f) of the Exchange Act) that occurred during the quarter ended March 31, 2004 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II. OTHER INFORMATION

 

Item 6. Exhibits and Reports on Form 8-K

 

(a) Exhibits:

 

31.1       Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2       Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1       Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2       Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

(b) Reports on Form 8-K:

 

None

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

   

Viragen International, Inc.

By:

 

/s/ Dennis W. Healey


   

Dennis W. Healey

   

Executive Vice President and

Principal Financial Officer

By:

 

/s/ Nicholas M. Burke


   

Nicholas M. Burke

   

Vice President, Controller and

Principal Accounting Officer

 

Date: May 7, 2004

 

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INDEX OF EXHIBITS

 

Exhibit No.

  

Description


31.1   

Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

31.2   

Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

32.1   

Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

32.2   

Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002