UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
| x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE QUARTER ENDED DECEMBER 31, 2003
OR
| ¨ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission File Number 0-17827
VIRAGEN INTERNATIONAL, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 11-2788282 | |
| (State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
865 SW 78th Avenue, Suite 100, Plantation, Florida 33324
(Address of principal executive offices)
(954) 233-8377
(Registrants telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes x No ¨
As of February 9, 2004, there were 68,113,764 shares of the registrants common stock outstanding, par value $0.01.
VIRAGEN INTERNATIONAL, INC. AND SUBSIDIARIES
| PART I - FINANCIAL INFORMATION |
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| Item 1. |
Financial Statements | |||
| 2) Consolidated condensed balance sheets as of December 31, 2003 (unaudited) and June 30, 2003 |
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| 4) Notes to consolidated condensed financial statements (unaudited) |
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| Item 2. |
Managements 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 |
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| Item 5. |
Other Information | |||
| Item 6. |
Exhibits and Reports on Form 8-K | |||
2
VIRAGEN INTERNATIONAL, INC. AND SUBSIDIARIES
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
| Three Months Ended December 31, |
Six Months Ended December 31, |
|||||||||||||||
| 2003 |
2002 |
2003 |
2002 |
|||||||||||||
| Product sales |
$ | 60,041 | $ | 126,592 | $ | 111,647 | $ | 471,477 | ||||||||
| Costs and expenses |
||||||||||||||||
| Cost of sales |
532,023 | 103,784 | 901,030 | 421,957 | ||||||||||||
| Research and development |
341,027 | 235,450 | 653,296 | 467,050 | ||||||||||||
| Selling, general and administrative |
939,388 | 890,359 | 1,786,172 | 1,718,125 | ||||||||||||
| Amortization of intangible assets |
38,814 | 58,108 | 76,227 | 115,125 | ||||||||||||
| Interest and other income |
(138,341 | ) | (75,205 | ) | (255,966 | ) | (89,307 | ) | ||||||||
| Interest expense |
44,945 | 48,819 | 84,275 | 98,538 | ||||||||||||
| Loss before income taxes |
(1,697,815 | ) | (1,134,723 | ) | (3,133,387 | ) | (2,260,011 | ) | ||||||||
| Income tax benefit |
10,957 | 19,386 | 21,914 | 38,772 | ||||||||||||
| Net loss |
$ | (1,686,858 | ) | $ | (1,115,337 | ) | $ | (3,111,473 | ) | $ | (2,221,239 | ) | ||||
| Loss per common share basic and diluted |
$ | (0.02 | ) | $ | (0.02 | ) | $ | (0.05 | ) | $ | (0.05 | ) | ||||
| Weighted average common shares basic and diluted |
68,113,764 | 46,540,427 | 68,113,764 | 46,516,083 | ||||||||||||
See notes to consolidated condensed financial statements which are an integral part of these statements.
3
VIRAGEN INTERNATIONAL, INC. AND SUBSIDIARIES
CONSOLIDATED CONDENSED BALANCE SHEETS
| December 31, 2003 |
June 30, 2003 |
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| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets |
||||||||
| Cash and cash equivalents |
$ | 319,964 | $ | 264,224 | ||||
| Accounts receivable |
74,867 | 105,334 | ||||||
| Inventories |
3,665,239 | 3,311,583 | ||||||
| Prepaid expenses |
126,211 | 173,254 | ||||||
| Other current assets |
197,907 | 61,184 | ||||||
| Total current assets |
4,384,188 | 3,915,579 | ||||||
| Property, plant and equipment |
||||||||
| Land, building and improvements |
3,263,769 | 3,143,965 | ||||||
| Equipment and furniture |
4,736,750 | 4,625,543 | ||||||
| Construction in progress |
1,383,830 | 551,493 | ||||||
| 9,384,349 | 8,321,001 | |||||||
| Less accumulated depreciation |
(3,122,476 | ) | (2,708,844 | ) | ||||
| 6,261,873 | 5,612,157 | |||||||
| Goodwill |
10,731,744 | 9,678,302 | ||||||
| Developed technology, net |
1,989,109 | 1,869,122 | ||||||
| $ | 23,366,914 | $ | 21,075,160 | |||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities |
||||||||
| Accounts payable |
$ | 870,058 | $ | 1,300,919 | ||||
| Accrued expenses and other liabilities |
398,727 | 598,157 | ||||||
| Line of credit |
842,391 | 999,192 | ||||||
| Current portion of long-term debt |
129,161 | 60,421 | ||||||
| Total current liabilities |
2,240,337 | 2,958,689 | ||||||
| Long-term debt, less current portion |
1,228,755 | 1,124,335 | ||||||
| Advances from parent |
7,999,992 | 3,680,530 | ||||||
| Deferred income tax liability |
522,282 | 544,196 | ||||||
| Commitments and contingencies |
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| Stockholders equity |
||||||||
| Common stock, $.01 par value; 90,000,000 shares authorized; 68,113,764 shares issued and outstanding at December 31, 2003 and June 30, 2003 |
681,138 | 681,138 | ||||||
| Additional paid-in capital |
45,537,903 | 45,537,903 | ||||||
| Accumulated deficit |
(39,062,724 | ) | (35,951,251 | ) | ||||
| Accumulated other comprehensive income |
4,219,231 | 2,499,620 | ||||||
| Total stockholders equity |
11,375,548 | 12,767,410 | ||||||
| $ | 23,366,914 | $ | 21,075,160 | |||||
See notes to consolidated condensed financial statements which are an integral part of these statements.
4
VIRAGEN INTERNATIONAL, INC. AND SUBSIDIARIES
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
| Six Months Ended December 31, |
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| 2003 |
2002 |
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| OPERATING ACTIVITIES |
||||||||
| Net loss |
$ | (3,111,473 | ) | $ | (2,221,239 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
| Depreciation |
374,103 | 354,055 | ||||||
| Amortization of intangible assets |
76,227 | 115,125 | ||||||
| Loss on sale of property, plant, and equipment |
19,794 | 8,578 | ||||||
| Deferred income tax benefit |
(21,914 | ) | (38,772 | ) | ||||
| Increase (decrease) relating to operating activities from: |
||||||||
| Accounts receivable |
30,467 | 286,882 | ||||||
| Inventories |
(353,656 | ) | (972,491 | ) | ||||
| Prepaid expenses and other current assets |
(89,680 | ) | 748,914 | |||||
| Accounts payable and accrued expenses |
(630,291 | ) | 603,441 | |||||
| Net cash used in operating activities |
(3,706,423 | ) | (1,115,507 | ) | ||||
| INVESTING ACTIVITIES |
||||||||
| Additions to property, plant and equipment, net |
(754,295 | ) | (314,437 | ) | ||||
| Net cash used in investing activities |
(754,295 | ) | (314,437 | ) | ||||
| FINANCING ACTIVITIES |
||||||||
| Advances from parent |
4,319,462 | 1,275,652 | ||||||
| Net (payment) borrowing on line of credit |
(247,008 | ) | 87,664 | |||||
| Net borrowing (payment) on long-term debt |
43,205 | (27,391 | ) | |||||
| Net cash provided by financing activities |
4,115,659 | 1,335,925 | ||||||
| Effect of exchange rate fluctuations on cash |
400,799 | 40,167 | ||||||
| Increase (decrease) in cash and cash equivalents |
55,740 | (53,852 | ) | |||||
| Cash and cash equivalents at beginning of period |
264,224 | 77,405 | ||||||
| Cash and cash equivalents at end of period |
$ | 319,964 | $ | 23,553 | ||||
See notes to consolidated condensed financial statements which are an integral part of these statements.
5
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 bodys most important natural defense mechanisms to foreign substances like viruses, and it also stimulates and modulates the human immune system. In addition, interferon inhibits the growth of various viruses including those associated with diseases like hepatitis, some types of cancer, multiple sclerosis, and severe acute respiratory syndrome (SARS).
We are a majority owned subsidiary of Viragen, Inc. (Viragen). As of December 31, 2003, Viragen owned 54,262,745 shares of our common stock representing approximately 79.7% of our 68,113,764 outstanding shares. We operate through our foreign wholly owned subsidiaries, ViraNative AB, a company located in Umeå, Sweden and Viragen (Scotland) Limited, a company located near Edinburgh, Scotland. ViraNative and Viragen (Scotland) house our manufacturing and laboratory facilities.
The accompanying interim consolidated condensed financial statements include Viragen International, Inc. and all of its subsidiaries, including those operating outside the United States of America. All significant transactions among our businesses have been eliminated. These statements have been prepared in conformity with accounting principles generally accepted in the United States, consistent in all material respects with those applied in our Annual Report on Form 10-K for the fiscal year ended June 30, 2003, filed with the Securities and Exchange Commission.
The accompanying interim consolidated condensed financial statements for Viragen International have been prepared in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, certain information and footnote disclosures normally included in financial statements included in our Annual Report on Form 10-K have been condensed or omitted. Certain amounts in prior periods consolidated condensed financial statements have been reclassified to conform to the current periods presentation. The reclassifications had no effect on previously reported results of operations. The accompanying interim consolidated condensed financial statements should be read in conjunction with Managements 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 managements most difficult and subjective judgments include: the assessment of recoverability of goodwill and long-lived assets; and the valuation of inventories. Actual results could differ materially from those estimates.
The interim financial information is unaudited, but, in the opinion of management, reflects all adjustments, including normal recurring adjustments, considered necessary for a fair presentation of results of the interim periods presented. Operating results for the three and six month periods ended December 31, 2003 are not necessarily indicative of the results that may be expected for the fiscal year ending June 30, 2004.
6
VIRAGEN INTERNATIONAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
(Unaudited)
NOTE A OVERVIEW AND BASIS OF PRESENTATION (Continued)
During the three and six months ended December 31, 2003 we incurred losses of approximately $1,687,000 and $3,111,000, respectively. During the years ended June 30, 2003, 2002 and 2001, we incurred losses of approximately $5,165,000, $5,591,000, and $7,915,000, respectively. We have an accumulated deficit of approximately $39,063,000 as of December 31, 2003. Management anticipates additional future losses as it commercializes its natural human alpha interferon product and conducts additional research activities and clinical trials to obtain additional regulatory approvals. We had cash and cash equivalents of approximately $320,000 and working capital of approximately $2,144,000 at December 31, 2003. We will require substantial additional funding to support our operations. Historically, Viragen, our parent company, has provided us with the working capital necessary to fund operations. Viragen has agreed to provide us with the working capital necessary to fund our operations through December 31, 2004. Viragen will be required to raise additional funds to support our operations subsequent to December 31, 2004. No assurance can be given that additional capital will be available when required or upon terms acceptable to Viragen.
NOTE B STOCK BASED COMPENSATION
As permitted under Statement of Financial Accounting Standards (SFAS) No. 148, Accounting for Stock-Based CompensationTransition and Disclosure, which amended SFAS No. 123, Accounting for Stock-Based Compensation, our employee stock option plan is accounted for under Accounting Principles Board Opinion No. 25 (APB 25), Accounting for Stock Issued to Employees, and related interpretations. Compensation expense for a stock option grant is recognized if the exercise price is less than the fair value of our common stock on the grant date.
The following table illustrates the effect on net loss and loss per common share if we had applied the fair value method to measure stock based compensation as required under the disclosure provisions of SFAS No. 123, Accounting for Stock Based Compensation.
| Three Months Ended December 31, |
Six Months Ended December 31, |
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| 2003 |
2002 |
2003 |
2002 |
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| Net loss as reported |
$ | (1,686,858 | ) | $ | (1,115,337 | ) | $ | (3,111,473 | ) | $ | (2,221,239 | ) | ||||
| Stock based compensation determined under the fair value method |
(1,740 | ) | (7,901 | ) | (8,363 | ) | (22,219 | ) | ||||||||
| Pro forma net loss |
$ | (1,688,598 | ) | $ | (1,123,238 | ) | $ | (3,119,836 | ) | $ | (2,243,458 | ) | ||||
| Loss per common share: |
||||||||||||||||
| Basic and diluted as reported |
$ | (0.02 | ) | $ | (0.02 | ) | $ | (0.05 | ) | $ | (0.05 | ) | ||||
| Basic and diluted pro forma |
$ | (0.02 | ) | $ | (0.02 | ) | $ | (0.05 | ) | $ | (0.05 | ) | ||||
7
VIRAGEN INTERNATIONAL, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
(Unaudited)
NOTE C ACQUISITION
On September 28, 2001, we acquired all of the outstanding shares of BioNative AB (BioNative), a privately held biotechnology company located in Umeå, Sweden. BioNative manufactured a natural human alpha interferon product called Interferon Alfanative®. Subsequent to the acquisition, BioNative was renamed ViraNative and Interferon Alfanative was further developed, and is now marketed as Multiferon.
The initial purchase consideration consisted of 2,933,190 shares of Viragen International common stock. In January 2002, ViraNative achieved two milestones as defined in the acquisition agreement. As a result, the former shareholders of ViraNative were issued an additional 8,799,570 shares of Viragen International common stock. In connection with the acquisition, the former shareholders of ViraNative are entitled to additional shares of Viragen International common stock contingent upon the attainment of certain milestones related to regulatory approvals:
| | 8,799,570 additional shares when and if the Mutual Recognition Procedures a |