UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
| (Mark One) | ||
| x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
| FOR THE QUARTER ENDED DECEMBER 31, 2003 | ||
| OR | ||
| o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission File Number 001-15823
VIRAGEN, INC.
| Delaware (State or other jurisdiction of incorporation or organization) |
59-2101668 (I.R.S. Employer Identification No.) |
865 SW 78th Avenue, Suite 100, Plantation, Florida 33324
(Address of principal executive offices)
(954) 233-8746
(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 o
As of February 5, 2004, there were 365,919,879 shares of the registrants common stock outstanding, par value $0.01.
VIRAGEN, INC. AND SUBSIDIARIES
INDEX
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
| 1) | Consolidated condensed statements of operations (unaudited) for the three and six months ended December 31, 2003 and 2002 | ||
| 2) | Consolidated condensed balance sheets as of December 31, 2003 (unaudited) and June 30, 2003 | ||
| 3) | Consolidated condensed statements of cash flows (unaudited) for the six months ended December 31, 2003 and 2002 | ||
| 4) | Notes to consolidated condensed financial statements (unaudited) |
Item 2. 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
Item 2. Changes in Securities and Use of Proceeds
Item 5. Other Information
Item 6. Exhibits and Reports on Form 8-K
SIGNATURES
2
VIRAGEN, INC. AND SUBSIDIARIES
| Three Months Ended | Six Months Ended | ||||||||||||||||
| December 31, | December 31, | ||||||||||||||||
| 2003 | 2002 | 2003 | 2002 | ||||||||||||||
Product sales |
$ | 60,041 | $ | 126,592 | $ | 111,647 | $ | 471,477 | |||||||||
Costs and expenses |
|||||||||||||||||
Cost of sales |
532,023 | 103,784 | 901,030 | 421,957 | |||||||||||||
Research and development |
811,318 | 914,225 | 1,625,740 | 1,746,553 | |||||||||||||
Selling, general and administrative |
1,727,258 | 1,715,741 | 3,193,521 | 3,446,989 | |||||||||||||
Amortization of intangible assets |
38,814 | 58,108 | 76,227 | 115,125 | |||||||||||||
Interest and other income |
(252,992 | ) | (123,155 | ) | (476,216 | ) | (164,759 | ) | |||||||||
Interest expense |
4,895,398 | 1,942,195 | 6,687,030 | 2,753,463 | |||||||||||||
Loss before income taxes and
minority interest |
(7,691,778 | ) | (4,484,306 | ) | (11,895,685 | ) | (7,847,851 | ) | |||||||||
Income tax benefit |
10,957 | 19,386 | 21,914 | 38,772 | |||||||||||||
Minority interest in loss of
subsidiary |
343,025 | 332,286 | 632,722 | 661,761 | |||||||||||||
Net loss |
(7,337,796 | ) | (4,132,634 | ) | (11,241,049 | ) | (7,147,318 | ) | |||||||||
Deduct required dividends on convertible
preferred stock, Series A |
663 | 663 | 1,325 | 1,325 | |||||||||||||
Net loss attributable to common stock |
$ | (7,338,459 | ) | $ | (4,133,297 | ) | $ | (11,242,374 | ) | $ | (7,148,643 | ) | |||||
Basic and diluted net loss per share of
common stock, after deduction for
required dividends on convertible
preferred stock |
$ | (0.02 | ) | $ | (0.04 | ) | $ | (0.04 | ) | $ | (0.06 | ) | |||||
Weighted average common shares basic
and diluted |
325,314,218 | 117,196,983 | 299,337,508 | 112,032,583 | |||||||||||||
See notes to consolidated financial statements which are an integral part of these statements.
3
VIRAGEN, INC. AND SUBSIDIARIES
| December 31, | June 30, | |||||||||||
| 2003 | 2003 | |||||||||||
| (Unaudited) | ||||||||||||
ASSETS |
||||||||||||
Current assets |
||||||||||||
Cash and cash equivalents |
$ | 11,147,672 | $ | 5,942,501 | ||||||||
Accounts receivable |
74,867 | 105,334 | ||||||||||
Inventories |
3,665,239 | 3,311,583 | ||||||||||
Prepaid expenses |
375,176 | 256,778 | ||||||||||
Other current assets |
256,197 | 633,637 | ||||||||||
Total current assets |
15,519,151 | 10,249,833 | ||||||||||
Property, plant and equipment |
||||||||||||
Land, building and improvements |
3,643,880 | 3,524,076 | ||||||||||
Equipment and furniture |
5,604,409 | 5,461,096 | ||||||||||
Construction in progress |
1,383,830 | 551,493 | ||||||||||
| 10,632,119 | 9,536,665 | |||||||||||
Less accumulated depreciation |
(4,031,995 | ) | (3,552,117 | ) | ||||||||
| 6,600,124 | 5,984,548 | |||||||||||
Goodwill |
10,731,744 | 9,678,302 | ||||||||||
Developed technology, net |
1,989,109 | 1,869,122 | ||||||||||
Deposits and other assets |
85,612 | 85,612 | ||||||||||
| $ | 34,925,740 | $ | 27,867,417 | |||||||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||||||
Current liabilities |
||||||||||||
Accounts payable |
$ | 1,007,154 | $ | 1,666,769 | ||||||||
Accrued expenses and other liabilities |
728,849 | 996,399 | ||||||||||
Convertible debentures |
| 4,051,762 | ||||||||||
Lines of credit and short term borrowings |
926,105 | 999,192 | ||||||||||
Current portion of long-term debt |
129,161 | 60,421 | ||||||||||
Total current liabilities |
2,791,269 | 7,774,543 | ||||||||||
Royalties payable |
107,866 | 107,866 | ||||||||||
Long-term debt, less current portion |
1,228,755 | 1,124,335 | ||||||||||
Minority interest in subsidiary |
2,313,232 | 2,596,269 | ||||||||||
Deferred income tax liability |
522,282 | 544,196 | ||||||||||
Commitments and contingencies |
||||||||||||
Stockholders equity |
||||||||||||
Convertible 10% Series A cumulative
preferred stock, $1.00 par value.
Authorized 375,000 shares; issued and
outstanding 2,650 shares. Liquidation
preference value: $10 per share,
aggregating $26,500 |
2,650 | 2,650 | ||||||||||
Common stock, $.01 par value;
700,000,000 shares authorized;
358,566,420 issued and outstanding at
December 31, 2003; 258,586,656 issued
and outstanding at June 30, 2003 |
3,585,665 | 2,585,866 | ||||||||||
Additional paid-in capital |
134,545,699 | 112,922,621 | ||||||||||
Accumulated deficit |
(113,532,923 | ) | (102,290,549 | ) | ||||||||
Accumulated other comprehensive income |
3,361,245 | 2,499,620 | ||||||||||
Total stockholders equity |
27,962,336 | 15,720,208 | ||||||||||
| $ | 34,925,740 | $ | 27,867,417 | |||||||||
See notes to consolidated financial statements which are an integral part of these statements.
4
VIRAGEN, INC. AND SUBSIDIARIES
| Six Months Ended | |||||||||||
| December 31, | |||||||||||
| 2003 | 2002 | ||||||||||
OPERATING ACTIVITIES |
|||||||||||
Net loss |
$ | (11,241,049 | ) | $ | (7,147,318 | ) | |||||
Adjustments to reconcile net loss to net cash used in operating activities: |
|||||||||||
Depreciation and amortization |
440,348 | 423,931 | |||||||||
Amortization of intangible assets |
76,227 | 115,125 | |||||||||
Loss on sale of property, plant and equipment |
19,794 | 8,578 | |||||||||
Compensation expense (reversal) on stock options and warrants |
20,259 | (61,493 | ) | ||||||||
Minority interest in loss of subsidiary |
(632,722 | ) | (661,761 | ) | |||||||
Amortization of discount on convertible debentures and promissory
notes |
6,141,296 | 2,422,951 | |||||||||
Amortization of deferred financing costs |
454,735 | 144,037 | |||||||||
Income tax benefit |
(21,914 | ) | (38,772 | ) | |||||||
Increase (decrease) relating to operating activities from: |
|||||||||||
Accounts receivable |
30,467 | 286,882 | |||||||||
Inventories |
(353,656 | ) | (972,491 | ) | |||||||
Prepaid expenses |
183,172 | 66,424 | |||||||||
Other current assets |
(77,295 | ) | 826,978 | ||||||||
Accounts payable |
(663,864 | ) | 726,597 | ||||||||
Accrued expenses and other liabilities |
(216,820 | ) | (233,306 | ) | |||||||
Notes due from directors |
| 4,836 | |||||||||
Net cash used in operating activities |
(5,841,022 | ) | (4,088,802 | ) | |||||||
INVESTING ACTIVITIES |
|||||||||||
Additions to property, plant and equipment, net |
(786,401 | ) | (329,349 | ) | |||||||
Net cash used in investing activities |
(786,401 | ) | (329,349 | ) | |||||||
FINANCING ACTIVITIES |
|||||||||||
Net proceeds from private equity placements |
9,007,733 | 2,735,523 | |||||||||
Net payments on lines of credit and short term promissory notes |
(460,613 | ) | (325,626 | ) | |||||||
Net borrowings (payments) on long-term debt |
43,205 | (27,391 | ) | ||||||||
Net proceeds from issuance of convertible debentures |
| 2,308,250 | |||||||||
Payments on convertible debentures |
(65,316 | ) | (1,111,113 | ) | |||||||
Collections on notes due from directors |
| 50,000 | |||||||||
Proceeds from exercise of debt and equity offering warrants, net |
2,906,786 | 14,433 | |||||||||
Net cash provided by financing activities |
11,431,795 | 3,644,076 | |||||||||
Effect of exchange rate fluctuations on cash |
400,799 | 40,167 | |||||||||
Increase (decrease) in cash and cash equivalents |
5,205,171 | (733,908 | ) | ||||||||
Cash and cash equivalents at beginning of period |
5,942,501 | 765,861 | |||||||||
Cash and cash equivalents at end of period |
$ | 11,147,672 | $ | 31,953 | |||||||
During the six months ended December 31, 2003 and December 31, 2002, we had the following non-cash financing activities:
| Six Months Ended | ||||||||
| December 31, | ||||||||
| 2003 | 2002 | |||||||
Purchase of insurance with notes payable |
$ | 301,570 | $ | 30,886 | ||||
Conversion of convertible debentures and accrued interest into common stock |
7,264,036 | 1,285,556 | ||||||
See notes to consolidated financial statements which are an integral part of these statements.
5
VIRAGEN, INC. AND SUBSIDIARIES
NOTE A OVERVIEW AND BASIS OF PRESENTATION
We are a biopharmaceutical company engaged in the research, development, manufacture and sale of a natural human alpha interferon product indicated for treatment of a broad range of viral and malignant diseases. We are also developing innovative technologies aimed at improving the manufacturing processes used to manufacture certain medical therapies. Specifically, we are primarily focused on three fields of research and development:
| | human leukocyte derived interferon natural alpha interferon derived from human white blood cells for the treatment of a wide range of viral and malignant diseases. | ||
| | avian transgenics technologies designed to produce protein-based drugs inside the egg whites of transgenic developed chickens. | ||
| | oncological therapies therapeutic proteins for the treatment of targeted cancers. |
We own approximately 79.7% of Viragen International, Inc. Viragen International operates primarily through its wholly owned subsidiaries, ViraNative AB, a company located in Umea, Sweden, and Viragen (Scotland) Limited, a company located near Edinburgh, Scotland. ViraNative and Viragen (Scotland) house our manufacturing and laboratory facilities.
The accompanying unaudited interim consolidated condensed financial statements include Viragen, Inc., Viragen International, Inc. and all subsidiaries, including those operating outside the United States of America. All significant transactions among our businesses have been eliminated. These statements have been prepared in conformity with accounting principles generally accepted in the United States, consistent in all material respects with those applied in our Annual Report on Form 10-K for the fiscal year ended June 30, 2003, filed with the Securities and Exchange Commission.
The accompanying unaudited interim consolidated condensed financial statements for Viragen, Inc. have been prepared in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, certain information and footnote disclosures normally included in financial statements included in our Annual Report on Form 10-K have been condensed or omitted. The accompanying unaudited interim consolidated condensed financial statements should be read in conjunction with 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.
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.
6
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
(Unaudited)
NOTE A OVERVIEW AND BASIS OF PRESENTATION (Continued)
The preparation of financial statements in accordance with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of income and expenses during the reporting period. The accounting estimates that require 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. During the three months ended December 31, 2003, we recorded an adjustment of non-cash interest expense totaling approximately $1.4 million as a result of the revaluation of warrants issued in connection with the April and June 2003 convertible debentures. Please see Note F and Managements Discussion and Analysis of Financial Condition and Results of Operations. Operating results for the three and six month periods ended December 31, 2003 are not necessarily indicative of the results that may be expected for the fiscal year ending June 30, 2004.
During the three and six months ended December 31, 2003 we incurred losses of approximately $7,338,000 and $11,241,000, respectively. During the years ended June 30, 2003, 2002 and 2001, we incurred significant losses of approximately $17,349,000, $11,089,000, and $11,008,000, respectively. We have an accumulated deficit of approximately $113,533,000 as of December 31, 2003. Management anticipates additional future losses as it commercializes its natural human alpha interferon product and conducts additional research activities and clinical trials to obtain additional regulatory approvals. We had cash and cash equivalents of approximately $11,148,000 and working capital of approximately $12,728,000 at December 31, 2003. We will require substantial additional funding to support our operations subsequent to December 31, 2004. Managements plans include obtaining additional capital through equity and debt financings. No assurance can be given that additional capital will be available when required or upon terms acceptable to us.
NOTE B STOCK BASED COMPENSATION
As permitted under Statement of Financial Accounting Standards (SFAS) No. 148, Accounting for Stock-Based 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.
7
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
(Unaudited)
NOTE B STOCK BASED COMPENSATION (Continued)
The following table illustrates the effect on net loss and loss per common share if we had applied the fair value method to measure stock based compensation as required under the disclosure provisions of SFAS No. 123, Accounting for Stock Based Compensation:
| Three Months Ended | Six Months Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2003 | 2002 | 2003 | 2002 | |||||||||||||
Net loss as reported |
$ | (7,337,796 | ) | $ | (4,132,634 | ) | $ | (11,241,049 | ) | $ | (7,147,318 | ) | ||||
Stock based compensation determined
under the fair value method |
(7,668 | ) | (132,320 | ) | (23,912 | ) | (282,491 | ) | ||||||||
Proforma net loss |
(7,345,464 | ) | (4,264,954 | ) | (11,264,961 | ) | (7,429,809 | ) | ||||||||
Preferred dividends, Series A |
(663 | ) | (663 | ) | (1,325 | ) | (1,325 | ) | ||||||||
Pro forma net loss attributable to
common stock |
$ | (7,346,127 | ) | $ | (4,265,617 | ) | $ | (11,266,286 | ) | $ | (7,431,134 | ) | ||||
Proforma loss per common share after
deduction of required dividends
on convertible preferred stock: |
||||||||||||||||
Basic and diluted as reported |
$ | (0.02 | ) | $ | (0.04 | ) | $ | (0.04 | ) | $ | (0.06 | ) | ||||
Basic and diluted pro forma |
$ | (0.02 | ) | $ | (0.04 | ) | $ | (0.04 | ) | $ | (0.07 | ) | ||||
NOTE C ACQUISITION
On September 28, 2001, Viragen International, Inc., our majority owned subsidiary, acquired all of the outstanding shares of BioNative AB (BioNative), a privately held biotechnology company located in Umeå, Sweden. BioNative manufactured a natural human alpha interferon product called Interferon Alfanative®. Subsequent to the acquisition, BioNative was renamed ViraNative and Interferon Alfanative was further developed, and is now marketed as Multiferon.
The initial purchase consideration consisted of 2,933,190 shares of Viragen International common stock. In January 2002, ViraNative achieved two milestones as defined in the acquisition agreement. As a result, the former shareholders of ViraNative were issued an additional 8,799,570 shares of Viragen International common stock. In connection with the acquisition, the former shareholders of ViraNative are entitled to additional shares of Viragen International common stock contingent upon the attainment of certain milestones related to regulatory approvals:
| | 8,799,570 additional shares when and if the Mutual Recognition Procedures application has received the approval of the requisite national and EU regulatory authorities for the use, sale and marketing of Multiferon in certain countries which must include Germany; and | ||
| | 2,933,190 additional shares when and if Multiferon has been approved by the requisite regulatory bodies in the EU for the treatment of Melanoma or when Multiferon has been approved by the requisite regulatory bodies for sale in the USA. |
If and as each of these milestones is met, the additional shares of Viragen International will be issued.
8
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
(Unaudited)
NOTE D GOODWILL AND OTHER INTANGIBLE ASSETS
The goodwill reported in our balance sheets as of December 31, 2003 and June 30, 2003 arose from Viragen Internationals acquisition of ViraNative on September 28, 2001 and the subsequent attainment of certain milestones by ViraNative in January 2002 as discussed in Note C. Subsequent to the initial recording of goodwill, the gross carrying amount has increased by approximately $3,144,000 as a result of foreign currency fluctuations between the U.S. dollar and the Swedish Krona. The following table reflects the changes in the carrying amount of goodwill for the six months ended December 31, 2003:
Balance as of June 30, 2003 |
$ | 9,678,302 | ||
Foreign exchange adjustment |
1,053,442 | |||
Balance as of December 31, 2003 |
$ | 10,731,744 | ||
In accordance with SFAS No. 142, Goodwill and Other Intangible Assets, this goodwill is not amortized but is reviewed for impairment on an annual basis or sooner if indicators of impairment arise. During the fourth quarter of our fiscal year ended June 30, 2003, we completed the annual impairment review of our goodwill with the assistance of an independent valuation firm. Based on the results of the review, we determined that no impairment of this asset existed as of April 1, 2003. As of December 31, 2003, we are not aware of any items or events that would cause us to adjust the recorded value of our goodwill for impairment. Future changes in the estimates used to conduct the impairment review, including revenue projections or the fair market value of Viragen Internationals common stock, could cause our analysis to indicate that our goodwill is impaired in subsequent periods and result in a write-off of a portion or all of our goodwill.
The developed technology intangible asset reported in our balance sheets as of December 31, 2003 and June 30, 2003 arose from Viragen Internationals acquisition of ViraNative on September 28, 2001. A detail of our developed technology intangible asset as of December 31, 2003 and June 30, 2003 is as follows:
| December 31, | June 30, | ||||||||
| 2003 | 2003 | ||||||||
Developed technology, gross |
$ | 2,364,675 | $ | 2,132,555 | |||||
Accumulated amortization |
(375,566 | ) | (263,433 | ) | |||||
Developed technology, net |
$ | 1,989,109 | $ | 1,869,122 | |||||
Our developed technology asset consists of the production and purification methods developed by ViraNative prior to the acquisition by Viragen International. This technology was complete and ViraNative had been selling the resultant natural interferon product prior to the acquisition by Viragen International. Developed technology was recorded at its estimated fair value at the date of acquisition. Subsequent to the initial recording of this intangible asset, the gross carrying amount has increased by approximately $715,000 as a result of foreign currency fluctuations between the U.S. dollar and the Swedish Krona.
9
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Continued)
(Unaudited)
NOTE D GOODWILL AND OTHER INTANGIBLE ASSETS (Continued)
Developed technology is being amortized over its estimated useful life of approximately 14 years. The 14-year life assigned to this asset was determined using a weighted average of the remaining lives of the patents on the various components of the production and purification processes.
The estimated aggregate amortization expense for the fiscal year ending J