UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
FORM 10-Q
(Mark One)
| (X) | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
| FOR THE QUARTER ENDED DECEMBER 31, 2002 | ||
| OR | ||
| ( ) | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission File Number 001-15823
VIRAGEN, INC.
| Delaware | 59-2101668 | |
| (State or other jurisdiction of | (I.R.S. Employer Identification No.) | |
| incorporation or organization) |
865 SW 78th Avenue, Suite 100, Plantation, Florida 33324
(Address of principal executive offices)
(954) 233-8746
(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 13, 2003 there were 147,695,712 shares of the issuers common stock outstanding, par value $0.01.
VIRAGEN, INC. AND SUBSIDIARIES
INDEX
PART I. FINANCIAL INFORMATION |
3 | ||
Item 1. Financial Statements |
3 | ||
1.) Consolidated condensed statements of operations for the three
and six months ended December 31, 2002 and 2001 |
3 | ||
2.) Consolidated condensed balance sheets as of December 31, 2002 and June 30, 2002 |
4 | ||
3.) Consolidated condensed statements of cash flows for the six months ended
December 31, 2002 and 2001 |
5 | ||
4.) Notes to consolidated condensed financial statements |
6 | ||
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations |
18 | ||
Item 3. Quantitative and Qualitative Disclosures About Market Risk |
31 | ||
Item 4. Controls and Procedures |
32 | ||
PART II. OTHER INFORMATION |
33 | ||
Item 1. Legal Proceedings |
33 | ||
Item 4. Submission of Matters to a Vote of Security Holders |
35 | ||
Item 6. Exhibits and Reports on Form 8-K |
36 | ||
SIGNATURES |
37 | ||
CERTIFICATION
OF CEO |
38 | ||
CERTIFICATION
OF CFO |
39 | ||
2
PART I FINANCIAL INFORMATION
Item 1. Financial Statements
VIRAGEN, INC. AND SUBSIDIARIES
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
| Three Months Ended | Six Months Ended | ||||||||||||||||
| December 31, | December 31, | ||||||||||||||||
| 2002 | 2001 | 2002 | 2001 | ||||||||||||||
Product sales |
$ | 126,592 | $ | 461,892 | $ | 471,477 | $ | 461,892 | |||||||||
Costs and expenses |
|||||||||||||||||
Cost of sales |
100,866 | 443,530 | 419,039 | 443,530 | |||||||||||||
Research and development |
855,049 | 1,347,439 | 1,687,377 | 2,839,761 | |||||||||||||
Selling, general and administrative |
1,715,876 | 1,972,130 | 3,447,124 | 3,253,748 | |||||||||||||
Amortization of intangible assets |
58,108 | 51,518 | 115,125 | 51,518 | |||||||||||||
Interest and other income |
(61,196 | ) | (52,926 | ) | (102,800 | ) | (138,312 | ) | |||||||||
Interest expense |
1,942,195 | 46,928 | 2,753,463 | 48,756 | |||||||||||||
Loss before income taxes and
minority interest |
(4,484,306 | ) | (3,346,727 | ) | (7,847,851 | ) | (6,037,109 | ) | |||||||||
Income tax benefit |
19,386 | 112 | 38,772 | 73,426 | |||||||||||||
Minority interest in loss of
subsidiaries |
332,286 | 264,013 | 661,761 | 362,281 | |||||||||||||
Net loss |
(4,132,634 | ) | (3,082,602 | ) | (7,147,318 | ) | (5,601,402 | ) | |||||||||
Deduct required dividends on convertible
preferred stock, Series A |
663 | 662 | 1,325 | 1,325 | |||||||||||||
Loss attributable to common stock |
$ | (4,133,297 | ) | $ | (3,083,264 | ) | $ | (7,148,643 | ) | $ | (5,602,727 | ) | |||||
Loss per common share, after deduction
of required dividends on convertible
preferred stock basic and diluted |
$ | (0.04 | ) | $ | (0.03 | ) | $ | (0.06 | ) | $ | (0.06 | ) | |||||
Weighted average common shares basic
and diluted |
117,196,983 | 99,907,811 | 112,032,583 | 99,756,747 | |||||||||||||
See notes to consolidated condensed financial statements which are an integral part of these statements.
3
VIRAGEN, INC. AND SUBSIDIARIES
CONSOLIDATED CONDENSED BALANCE SHEETS
| December 31, | June 30, | |||||||||||
| 2002 | 2002 | |||||||||||
| (Unaudited) | ||||||||||||
ASSETS |
||||||||||||
Current assets |
||||||||||||
Cash and cash equivalents |
$ | 31,953 | $ | 765,861 | ||||||||
Accounts receivable |
63,083 | 349,965 | ||||||||||
Inventories |
2,839,059 | 1,866,568 | ||||||||||
Prepaid expenses |
381,572 | 399,626 | ||||||||||
Other current assets |
328,372 | 1,033,287 | ||||||||||
Total current assets |
3,644,039 | 4,415,307 | ||||||||||
Property, plant and equipment |
||||||||||||
Land,
building and improvements |
3,391,675 | 3,254,701 | ||||||||||
Equipment and furniture |
5,289,766 | 5,022,695 | ||||||||||
Construction in progress |
502,050 | 375,373 | ||||||||||
| 9,183,491 | 8,652,769 | |||||||||||
Less accumulated depreciation |
(3,061,248 | ) | (2,678,299 | ) | ||||||||
| 6,122,243 | 5,974,470 | |||||||||||
Goodwill |
8,887,444 | 8,460,940 | ||||||||||
Developed technology, net |
1,785,503 | 1,765,618 | ||||||||||
Other intangible assets, net |
| 50,619 | ||||||||||
Deposits and other assets |
129,650 | 129,650 | ||||||||||
| $ | 20,568,879 | $ | 20,796,604 | |||||||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||||||
Current liabilities |
||||||||||||
Accounts payable |
$ | 2,334,998 | $ | 1,583,333 | ||||||||
Accrued expenses and other liabilities |
849,098 | 1,081,079 | ||||||||||
Convertible debentures |
1,528,636 | 711,982 | ||||||||||
Lines of credit and short term promissory notes |
1,023,095 | 1,294,904 | ||||||||||
Current portion of long-term debt |
122,408 | 72,374 | ||||||||||
Deferred tax liability, current |
43,828 | 60,686 | ||||||||||
Total current liabilities |
5,902,063 | 4,804,358 | ||||||||||
Royalties payable |
107,866 | 107,866 | ||||||||||
Long-term debt, less current portion |
980,408 | 1,023,948 | ||||||||||
Minority interest in subsidiaries |
2,334,094 | 2,845,616 | ||||||||||
Deferred tax liability |
522,282 | 544,196 | ||||||||||
Commitments and Contingencies |
||||||||||||
Stockholders equity |
||||||||||||
Convertible 10% Series A cumulative preferred
stock, $1.00 par value. Authorized 375,000
shares; issued and outstanding 2,650 shares.
Liquidation preference value: $10 per share,
aggregating $26,500 |
2,650 | 2,650 | ||||||||||
Common stock, $.01 par value. Authorized
150,000,000 shares at December 31, 2002 and June
30, 2002; 127,241,940 issued and 126,396,663
outstanding at December 31, 2002; 104,831,855
issued and 103,986,578 outstanding at June 30, 2002 |
1,272,418 | 1,048,317 | ||||||||||
Capital in excess of par value |
101,485,650 | 96,197,939 | ||||||||||
Treasury stock, 845,277 shares at December 31,
2002 and June 30, 2002, at cost |
(1,277,613 | ) | (1,277,613 | ) | ||||||||
Accumulated deficit |
(92,087,856 | ) | (84,939,213 | ) | ||||||||
Accumulated other comprehensive income |
1,377,829 | 656,237 | ||||||||||
Notes due from directors |
(50,912 | ) | (217,697 | ) | ||||||||
Total stockholders equity |
10,722,166 | 11,470,620 | ||||||||||
| $ | 20,568,879 | $ | 20,796,604 | |||||||||
See notes to consolidated condensed financial statements which are an integral part of these statements.
4
VIRAGEN, INC. AND SUBSIDIARIES
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
| Six Months Ended | |||||||||||
| December 31, | |||||||||||
| 2002 | 2001 | ||||||||||
OPERATING ACTIVITIES |
|||||||||||
Net loss |
$ | (7,147,318 | ) | $ | (5,601,402 | ) | |||||
Adjustments to reconcile net loss to net cash used in operating activities: |
|||||||||||
Depreciation and amortization |
423,931 | 336,298 | |||||||||
Amortization of intangible assets |
115,125 | 51,518 | |||||||||
Loss on sale of property, plant and equipment |
8,578 | | |||||||||
Compensation expense on stock options and warrants |
(61,493 | ) | 131,801 | ||||||||
Minority interest in loss of subsidiaries |
(661,761 | ) | (362,281 | ) | |||||||
Amortization of discount on convertible debentures and promissory
notes |
2,422,951 | | |||||||||
Amortization of deferred financing costs |
144,037 | | |||||||||
Income tax benefit |
(38,772 | ) | | ||||||||
Increase (decrease) relating to operating activities from: |
|||||||||||
Accounts receivable |
286,882 | 60,726 | |||||||||
Inventories |
(972,491 | ) | 204,749 | ||||||||
Prepaid expenses |
66,424 | 166,787 | |||||||||
Other current assets |
826,978 | 179,556 | |||||||||
Deposit and other assets |
| 21,404 | |||||||||
Accounts payable |
726,597 | (544,115 | ) | ||||||||
Accrued expenses and other liabilities |
(233,306 | ) | 61,989 | ||||||||
Notes due from directors |
4,836 | (3,549 | ) | ||||||||
Net cash used in operating activities |
(4,088,802 | ) | (5,296,519 | ) | |||||||
INVESTING ACTIVITIES |
|||||||||||
Additions to property, plant and equipment |
(329,349 | ) | (219,556 | ) | |||||||
Acquisition of ViraNative, net of cash acquired |
| (165,627 | ) | ||||||||
Net cash used in investing activities |
(329,349 | ) | (385,183 | ) | |||||||
FINANCING ACTIVITIES |
|||||||||||
Net proceeds from private placements |
2,735,523 | 332,199 | |||||||||
Net borrowings on lines of credit and short term promissory notes |
(325,626 | ) | 46,171 | ||||||||
Payments on long-term debt |
(27,391 | ) | (34,138 | ) | |||||||
Net proceeds from issuance of convertible debentures |
2,308,250 | | |||||||||
Payments on convertible debentures |
(1,111,113 | ) | | ||||||||
Collections on notes due from directors |
50,000 | 50,000 | |||||||||
Proceeds from exercise of options and warrants |
14,433 | 238,238 | |||||||||
Net cash provided by financing activities |
3,644,076 | 632,470 | |||||||||
Effect of exchange rate fluctuations on cash |
40,167 | (85,684 | ) | ||||||||
Decrease in cash and cash equivalents |
(733,908 | ) | (5,134,916 | ) | |||||||
Cash and cash equivalents at beginning of period |
765,861 | 7,659,153 | |||||||||
Cash and cash equivalents at end of period |
$ | 31,953 | $ | 2,524,237 | |||||||
See notes to consolidated condensed financial statements which are an integral part of these statements.
5
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
NOTE A CONSOLIDATION AND BASIS OF PRESENTATION
Viragen, Inc. and its subsidiaries are engaged in the research, development, manufacture and sale of certain immunological products for the treatment of life-threatening illnesses. We are also in the business of developing innovative technologies aimed at improving the manufacturing processes used to produce certain medical therapies.
The accompanying unaudited consolidated condensed financial statements include Viragen, Inc., Viragen International, Inc. and all subsidiaries, including those operating outside the United States of America. All significant transactions among our businesses have been eliminated. The consolidated condensed financial statements have been prepared in conformity with accounting principles generally accepted in the United States, which contemplate continuation of the Company as a going concern.
As of December 31, 2002 and June 30, 2002 our ownership interest in Viragen International was approximately 72.8% and 70.2%, respectively. If ViraNative, a wholly-owned subsidiary of Viragen International acquired in September 2001, meets all of the milestones under the acquisition agreement, our ownership interest in Viragen International would be reduced to approximately 59.2% assuming additional Viragen International shares are not issued for any other purposes.
The accompanying unaudited interim consolidated condensed financial statements for Viragen have been prepared in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States have been condensed or omitted. The balance sheet at June 30, 2002 has been derived from the audited financial statements at that date. Certain amounts in prior years consolidated condensed financial statements have been reclassified to conform to the current years presentation. The reclassifications had no effect on previously reported results of operations.
For the fiscal year ended June 30, 2002, the report of our independent auditors contains an explanatory paragraph indicating substantial doubt as to our ability to continue as a going concern, due to our financial condition. Our financial condition has not improved subsequent to our fiscal year end. If we are unable to raise additional debt or equity funding it will be necessary for us to significantly curtail or suspend a portion or all of our operations. No assurance can be given that additional funding will be available or if available, under what terms.
During fiscal 2002, 2001 and 2000, we incurred significant losses of approximately $11,089,000, $11,008,000 and $12,311,000, respectively, and has an accumulated deficit of approximately $92,088,000 as of December 31, 2002. Additionally, we had a cash balance of approximately $32,000 and a working capital deficit of approximately $2,258,000 at December 31, 2002. Management anticipates additional future losses as it commercializes its natural human interferon product and conducts additional research activities and clinical trials to obtain additional regulatory approvals. Accordingly, we will require substantial additional funding. These factors, among others, raise substantial doubt about our ability to continue as a going concern. The accompanying consolidated condensed financial statements do not include any adjustments relating to the recoverability and classification of asset carrying amounts or the amount and classification of liabilities that might result from the outcome of these uncertainties.
6
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS(CONTINUED)
NOTE B INTERIM ADJUSTMENTS AND USE OF ESTIMATES
The preparation of financial statements in accordance with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of income and expenses during the reporting period. Actual results could differ from those estimates. In the opinion of management, all adjustments, including normal recurring accruals, considered necessary for a fair presentation have been included.
Operating results for the three and six months periods ended December 31, 2002 are not necessarily indicative of the results that may be expected for the fiscal year ended June 30, 2003.
The unaudited interim consolidated condensed financial statements should be read in conjunction with 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 the Companys Annual Report on Form 10-K for the year ended June 30, 2002, filed with the Securities and Exchange Commission.
NOTE C ACQUISITION
On September 28, 2001, Viragen International, Inc., our majority owned subsidiary, acquired all of the outstanding shares of BioNative AB (BioNative), a privately held biotechnology company located in Umeå, Sweden. BioNative manufactured a human leukocyte interferon (alpha) product called Interferon Alfanative®. Subsequent to the acquisition, BioNative was renamed ViraNative and Interferon Alfanative was further developed into our new product, Multiferon®.
The initial purchase consideration consisted of 2,933,190 shares of Viragen International common stock, which was valued at approximately $2.2 million based on the market price of Viragen International common stock at the date of the acquisition. In addition, Viragen International incurred approximately $204,000 in acquisition related costs. In January 2002, ViraNative received notification from the Medical Products Agency in Sweden that ViraNatives Re-registration certificate was approved and as a second line treatment for any indication where patients did not respond to recombinant interferon. At that time, the former shareholders of ViraNative were issued an additional 8,799,570 shares of Viragen International common stock, which represented achievement of the first two milestones as defined in the acquisition agreement. The additional shares of Viragen International common stock were valued at approximately $6.6 million, based on the market price of Viragen International common stock at the time the milestones were achieved, all of which was allocated to goodwill.
7
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS(CONTINUED)
NOTE C ACQUISITION (Continued)
In connection with the acquisition, the former shareholders of ViraNative are entitled to additional shares of Viragen International common stock contingent upon the attainment of certain milestones related to regulatory approvals:
| | 8,799,570 additional shares when and if the Mutual Recognition Procedures application has received the approval of the requisite national and EU regulatory authorities for the use, sale and marketing of Multiferon in certain countries which must include Germany; and | ||
| | 2,933,190 additional shares when and if Multiferon has been approved by the requisite regulatory bodies in the EU for the treatment of Melanoma or when Multiferon has been approved by the requisite regulatory bodies for sale in the USA. |
As each of these milestones is met, the additional shares of Viragen International will be issued, which will result in the recognition of additional intangible assets.
The acquisition, completed on September 28, 2001, was accounted for as a purchase under Statement of Financial Accounting Standards No. 141 and, accordingly, the results of ViraNatives operations are included in the Companys consolidated results from the date of the acquisition.
NOTE D GOODWILL AND OTHER INTANGIBLE ASSETS
The goodwill reported in our balance sheets as of December 31, 2002 and June 30, 2002 arose from our acquisition of ViraNative in September 2001 and the subsequent achievement of certain milestones by ViraNative in January 2002 as discussed in Note C. In accordance with the provisions of SFAS No. 142, goodwill will not be amortized but will be reviewed for impairment on an annual basis or sooner if indicators of impairment arise. As of the date of these financial statements, we are not aware of any items or events that would cause us to adjust the recorded value of our goodwill for impairment. The following table reflects the changes in the carrying amount of goodwill for the six months ended December 31, 2002.
Balance as of June 30, 2002 |
$ | 8,460,940 | ||
Goodwill acquired during the year |
| |||
Foreign exchange adjustment |
426,504 | |||
Balance as of December 31, 2002 |
$ | 8,887,444 | ||
The intangible assets reported in our balance sheets as of December 31, 2002 and June 30, 2002 arose from our acquisition of ViraNative in September 2001. As of December 31, 2002, intangible assets consist of the following:
| Gross Carrying | Accumulated | |||||||
| Amount | Amortization | |||||||
Developed technology |
$ | 1,958,294 | $ | (172,791 | ) | |||
Customer contract |
132,927 | (132,927 | ) | |||||
Total intangible assets |
$ | 2,091,221 | $ | (305,718 | ) | |||
8
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS(CONTINUED)
NOTE D GOODWILL AND OTHER INTANGIBLE ASSETS (Continued)
The developed technology consists of the production and purification methods developed by ViraNative. The developed technology is being amortized over its estimated useful life of approximately 14 years. The 14-year life assigned to this asset was determined using a weighted average of the remaining lives of the patents on the various components of the production and purification processes. The customer contract represented a purchase agreement with a customer that expired in December 2002 and accordingly this intangible asset was fully amortized at December 31, 2002. The estimated aggregate amortization expense for the fiscal year ended June 30, 2003 and the four succeeding fiscal years is as follows:
2003 |
$ | 182,000 | ||
2004 |
133,000 | |||
2005 |
133,000 | |||
2006 |
133,000 | |||
2007 |
133,000 |
NOTE E INVENTORIES
Inventories are stated at the lower of cost or market (estimated net realizable value). Raw materials and supplies cost is determined on a first-in, first-out basis. Work in process and finished products costs consisting of materials, labor and overhead are recorded at a standard cost (which approximates actual cost). If the cost of the inventories exceeds their expected market value, provisions are recorded currently for the difference between the cost and the market value. These provisions are determined based on estimates. Finished products consist of purified human leukocyte interferon.
Inventories consisted of the following at December 31, 2002 and June 30, 2002:
| December 31, | June 30, | |||||||
| 2002 | 2002 | |||||||
Finished products |
$ | 677,934 | $ | 410,343 | ||||
Work in process |
2,025,320 | 1,293,851 | ||||||
Raw materials and supplies |
135,805 | 162,374 | ||||||
Total inventories |
$ | 2,839,059 | $ | 1,866,568 | ||||
9
VIRAGEN, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS(CONTINUED)
NOTE F DEBT
Lines of Credit and Short Term Borrowings
On May 15, 2000, Viragen was approved for a $500,000 unsecured line of credit with a bank located in Florida. Interest is payable at the greater of 7.25% or the Prime Rate, as quoted by The Wall Street Journal and is adjustable daily. This unsecured line of credit was renewed on May 15, 2001, under the same terms, and remained unused until May 2002. The facility was renewed on May 15, 2002 and subsequently through January 15, 2003. There were no outstanding borrowings under this credit facility as of December 31, 2002 compared to $300,000 outstanding at June 30, 2002.
Through Viragen Internationals Swedish subsidiary, ViraNative, we may borrow up to approximately $960,000 under an overdraft facility with a bank in Sweden. Borrowings outstanding under this facility are at a floating rate of interest which was approximately 7.5% at December 31, 2002. The facility renews annually and was renewed in December 2002. Outstanding borrowings under this agreement totaled approximately $960,000 as of December 31, 2002. The overdraft facility is secured by certain assets of ViraNative including inventories and accounts receivable.
During August 2002, Viragen obtained short term financing of approximately $31,000 for the purchase of certain corporate insurance policies. Outstanding borrowings under this arrangement bear interest at an effective rate of approximately 6.45%. Principal and interest payments of approximately $3,200 are payable monthly. The outstanding balance on this short term borrowing was approximately $19,000 as of December 31, 2002. The final payment on this short term borrowing will be in June 2003.
During June 2002, Viragen obtained short term financing of approximately $183,000 for the purchase of certain corporate insurance policies. Outstanding borrowings under this arrangement bear interest at an effective rate of approximately 5.53%. Principal and interest payments of approximately $21,000 are payable monthly. The outstanding balance on this short term borrowing was approximately $62,000 as of December 31, 2002. The final payment on this short term borrowing will be in March 2003.
Long-Term Debt
As of December 31, 2002, our long-term debt totaling approximately $1,103,000 consisted of a mortgage loan agreement with a Swedish bank and two other loan agreements with Swedish governmental agencies. Outstanding borrowings under these agreements bear interest at rates ranging from 5.35% to 11.4%.
Long-term debt includes a 25-year mortgage obtained to purchase one of our facilities in Sweden. The outstanding principal balance on this loan was approximately $639,000 at December 31, 2002. This loan carries a floating rate of interest which was approximately 5.35% at December 31, 2002. We are required to make quarterly payments of principal and interest of approximately $7,000 under this agreement. This loan matures in September 2024 and is secured by the related land and building with a carrying value of approximately $766