UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
| x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2004
or
| ¨ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE TRANSITION PERIOD FROM TO
Commission File Number: 000-30681
DENDREON CORPORATION
(Exact name of registrant as specified in its charter)
| DELAWARE | 22-3203193 | |
| (State or other jurisdiction of incorporation or organization) |
(IRS Employer Identification No.) |
3005 FIRST AVENUE, SEATTLE, WASHINGTON 98121
(Address of principal executive offices, including zip code)
(206) 256-4545
(Registrants telephone number, including area code)
www.dendreon.com
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. x Yes ¨ No
Indicate by check mark whether the registrant (1) is an accelerated filer (as defined in Rule 12b-2 of the Act). x Yes ¨ No
The number of shares of the registrants common stock, $.001 par value, outstanding as of October 31, 2004 was 58,994,134.
DENDREON CORPORATION
| PAGE NO. | ||||||
| PART I. |
FINANCIAL INFORMATION | |||||
| Item 1. | Financial Statements | |||||
| a) Consolidated Balance Sheets as of September 30, 2004 (unaudited) and December 31, 2003 | 2 | |||||
| 3 | ||||||
| 4 | ||||||
| 5 | ||||||
| Item 2. | Managements Discussion and Analysis of Financial Condition and Results of Operations | 9 | ||||
| Item 3. | Qualitative and Quantitative Disclosures About Market Risk | 28 | ||||
| Item 4. | Controls and Procedures | 28 | ||||
| PART II. |
OTHER INFORMATION | |||||
| Item 6. | Exhibits | 29 | ||||
| 30 | ||||||
| 31 | ||||||
PART IFINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
| September 30, 2004 |
December 31, 2003 |
|||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: |
||||||||
| Cash and cash equivalents |
$ | 35,104 | $ | 44,349 | ||||
| Short-term investments |
154,431 | 55,692 | ||||||
| Accounts receivable |
5,972 | 5,689 | ||||||
| Other current assets |
3,389 | 2,974 | ||||||
| Total current assets |
198,896 | 108,704 | ||||||
| Property and equipment, net |
3,792 | 5,011 | ||||||
| Long-term investments |
22,228 | 13,150 | ||||||
| Restricted cash |
304 | 303 | ||||||
| Receivable, net of current portion |
10,601 | 9,943 | ||||||
| Deposits and other assets |
798 | 734 | ||||||
| Total assets |
$ | 236,619 | $ | 137,845 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: |
||||||||
| Accounts payable |
$ | 3,590 | $ | 1,221 | ||||
| Accrued liabilities |
9,568 | 8,473 | ||||||
| Accrued acquisition-related restructuring liabilities |
1,746 | 924 | ||||||
| Accrued compensation |
2,569 | 4,052 | ||||||
| Deferred revenue |
97 | 107 | ||||||
| Current portion of capital lease obligations |
1,194 | 1,463 | ||||||
| Total current liabilities |
18,764 | 16,240 | ||||||
| Deferred revenue, less current portion |
659 | 725 | ||||||
| Capital lease obligations, less current portion |
1,758 | 899 | ||||||
| Deferred foreign tax |
| 994 | ||||||
| Stockholders equity: |
||||||||
| Preferred stock, $0.001 par value; 10,000,000 shares authorized, no shares issued or outstanding |
| | ||||||
| Common stock, $0.001 par value; 80,000,000 shares authorized, 58,439,366 and 44,926,284 shares issued and outstanding at September 30, 2004 and December 31, 2003, respectively |
58 | 45 | ||||||
| Additional paid-in capital |
411,175 | 263,610 | ||||||
| Deferred stock-based compensation |
(686 | ) | (651 | ) | ||||
| Accumulated other comprehensive loss |
(456 | ) | (61 | ) | ||||
| Accumulated deficit |
(194,653 | ) | (143,956 | ) | ||||
| Total stockholders equity |
215,438 | 118,987 | ||||||
| Total liabilities and stockholders equity |
$ | 236,619 | $ | 137,845 | ||||
See accompanying notes
Page 2
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
| Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
| 2004 |
2003 |
2004 |
2003 |
|||||||||||||
| Revenue |
$ | 69 | $ | 1,777 | $ | 4,960 | $ | 5,376 | ||||||||
| Operating expenses: |
||||||||||||||||
| Research and development |
20,240 | 10,351 | 46,345 | 26,505 | ||||||||||||
| Acquired in-process research and development |
| 1,780 | | 1,780 | ||||||||||||
| General and administrative |
2,410 | 3,481 | 12,012 | 6,786 | ||||||||||||
| Marketing |
527 | 125 | 1,335 | 426 | ||||||||||||
| Total operating expenses |
23,177 | 15,737 | 59,692 | 35,497 | ||||||||||||
| Loss from operations |
(23,108 | ) | (13,960 | ) | (54,732 | ) | (30,121 | ) | ||||||||
| Interest income |
1,108 | 400 | 2,983 | 779 | ||||||||||||
| Interest expense |
(50 | ) | (168 | ) | (220 | ) | (353 | ) | ||||||||
| Other expense |
| | (290 | ) | | |||||||||||
| Loss before income taxes |
(22,050 | ) | (13,728 | ) | (52,259 | ) | (29,695 | ) | ||||||||
| Foreign tax benefit |
| | 1,562 | | ||||||||||||
| Net loss |
$ | (22,050 | ) | $ | (13,728 | ) | $ | (50,697 | ) | $ | (29,695 | ) | ||||
| Basic and diluted net loss per share |
$ | (0.38 | ) | $ | (0.35 | ) | $ | (0.90 | ) | $ | (0.95 | ) | ||||
| Shares used in computation of basic and diluted net loss per share |
58,245 | 39,764 | 56,513 | 31,420 | ||||||||||||
See accompanying notes
Page 3
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
| Nine Months Ended September 30, |
||||||||
| 2004 |
2003 |
|||||||
| OPERATING ACTIVITIES |
||||||||
| Net loss |
$ | (50,697 | ) | $ | (29,695 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
| Acquired in-process research and development |
| 1,780 | ||||||
| Depreciation expense |
1,852 | 1,583 | ||||||
| Non-cash stock-based compensation expense |
773 | 378 | ||||||
| Non-cash stock-based consulting expense |
| 447 | ||||||
| Non-cash interest expense |
11 | 12 | ||||||
| Impairment of fixed assets |
689 | | ||||||
| Changes in current assets and liabilities: |
||||||||
| Accounts receivable |
(941 | ) | 1,760 | |||||
| Other current assets |
(427 | ) | (219 | ) | ||||
| Deposits and other assets |
(64 | ) | 12 | |||||
| Deferred revenue |
(76 | ) | (4,072 | ) | ||||
| Accounts payable |
2,369 | (495 | ) | |||||
| Accrued liabilities and compensation |
(560 | ) | (908 | ) | ||||
| Net cash used in operating activities |
(47,071 | ) | (29,417 | ) | ||||
| INVESTING ACTIVITIES |
||||||||
| Purchases of investments |
(237,989 | ) | (44,474 | ) | ||||
| Maturities of investments |
129,777 | 57,005 | ||||||
| Proceeds from asset disposals |
174 | 500 | ||||||
| Purchases of property and equipment |
(1,496 | ) | (1,505 | ) | ||||
| Net cash acquired from Corvas International, Inc. |
| 1,052 | ||||||
| Net cash provided by (used in) investing activities |
(109,534 | ) | 12,578 | |||||
| FINANCING ACTIVITIES |
||||||||
| Payments on long-term debt |
| (10,000 | ) | |||||
| Proceeds from sale-leaseback financing arrangements |
1,705 | 856 | ||||||
| Payments on capital lease obligations |
(1,114 | ) | (902 | ) | ||||
| Proceeds from sale of equity securities |
140,461 | 30,709 | ||||||
| Proceeds from exercise of stock options |
5,163 | 491 | ||||||
| Issuance of common stock under the Employee Stock Purchase Plan |
1,145 | 552 | ||||||
| Net cash provided by financing activities |
147,360 | 21,706 | ||||||
| NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS |
(9,245 | ) | 4,867 | |||||
| CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR |
44,349 | 11,263 | ||||||
| CASH AND CASH EQUIVALENTS AT END OF PERIOD |
$ | 35,104 | $ | 16,130 | ||||
| Supplemental Schedule of Noncash Investing and Financing Activities: |
||||||||
| Equity instruments issued for acquisition |
$ | | $ | 62,930 | ||||
| Stock options assumed in acquisition |
$ | | $ | 4,381 | ||||
See accompanying notes
Page 4
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)
1. BUSINESS, PRINCIPLES OF CONSOLIDATION AND BASIS OF PRESENTATION
Description of Business
We were founded in 1992 as a Delaware corporation and we are headquartered in Seattle, Washington. We are a biotechnology company focused on the discovery, development and commercialization of targeted therapies for cancer. Our portfolio includes product candidates to treat a wide range of cancers using therapeutic vaccines, monoclonal antibodies, and small molecules. Our most advanced product candidate is Provenge®, a therapeutic vaccine for the treatment of prostate cancer.
Principles of Consolidation
The consolidated financial statements include our accounts and the accounts of our wholly owned subsidiary. All material inter-company transactions and balances have been eliminated in consolidation. On July 30, 2003, we completed the acquisition of Corvas International, Inc., or Corvas (See Note 3 Significant Events). In accordance with Statement of Financial Accounting Standards (SFAS), No. 141, Business Combinations, we have included the results of operations of Corvas in our consolidated results since the acquisition on July 30, 2003.
Basis of Presentation
The accompanying unaudited financial statements reflect, in the opinion of management, all adjustments (consisting of normal recurring adjustments) necessary for a fair presentation of our financial position, results of operations and cash flows for each period presented in accordance with accounting principles generally accepted in the United States for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, 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 from the accompanying statements. These interim financial statements should be read in conjunction with the audited financial statements and related notes thereto, which are included in our Annual Report on Form 10-K for the year ended December 31, 2003. The accompanying financial information as of December 31, 2003 has been derived from audited financial statements. Operating results for the three-month and nine-month periods ended September 30, 2004 are not necessarily indicative of future results that may be expected for the year ending December 31, 2004. Certain prior year items have been reclassified to conform to the current year presentation, including certain operating expenses aggregating approximately $1.2 million and $2.8 million previously reported as general and administrative expenses that have been reclassified to research and development and marketing expenses for the three and nine months ended September 30, 2003, respectively. Items reclassified include certain costs related to human resources, facilities, information technology, finance and accounting.
2. RECENT ACCOUNTING PRONOUNCEMENTS
In January 2003, the FASB issued FIN No. 46, Consolidation of Variable Interest Entities. This interpretation of Accounting Research Bulletin No. 51, Consolidated Financial Statements, addresses consolidation of business enterprises of variable interest entities in which: (1) the equity investment at risk is not sufficient to permit the entity to finance its activities without additional subordinated financial support from other parties, which is provided through other interest that will absorb some or all of the expected losses of the entity and (2) the equity investors lack one or more of certain essential characteristics of a controlling interest. FIN No. 46 became effective on January 1, 2004. Adoption of this standard had no material impact on our financial position, results of operations or cash flows.
3. SIGNIFICANT EVENTS
Page 5