UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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 QUARTERLY PERIOD ENDED MARCH 31, 2003 |
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)
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
The number of shares of the registrants common stock, $.001 par value, outstanding as of April 24, 2003 was 26,813,004.
INDEX
PAGE NO. | ||||||
PART I. |
FINANCIAL INFORMATION |
|||||
Item 1. |
Financial Statements |
|||||
a) Condensed Balance Sheets as of March 31, 2003 (unaudited) and December 31, 2002 |
2 | |||||
b) Condensed Statements of Operations for the Three Months Ended March 31, 2003 and 2002 (unaudited) |
3 | |||||
c) Condensed Statements of Cash Flows for the Three Months Ended March 31, 2003 and 2002 (unaudited) |
4 | |||||
5 | ||||||
Item 2. |
Managements Discussion and Analysis of Financial Condition and Results of Operations |
7 | ||||
Item 3. |
19 | |||||
Item 4. |
19 | |||||
PART II. |
OTHER INFORMATION |
|||||
Item 6. |
19 | |||||
21 | ||||||
22 | ||||||
25 |
PART 1FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
CONDENSED BALANCE SHEETS
(in thousands, except share and per share amounts)
March 31, 2003 |
December 31, 2002 |
|||||||
(unaudited) |
||||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ |
13,321 |
|
$ |
11,263 |
| ||
Short-term investments |
|
34,133 |
|
|
35,614 |
| ||
Restricted cash |
|
|
|
|
308 |
| ||
Accounts receivable |
|
623 |
|
|
1,760 |
| ||
Other current assets |
|
1,692 |
|
|
2,309 |
| ||
Total current assets |
|
49,769 |
|
|
51,254 |
| ||
Property and equipment, net |
|
3,428 |
|
|
3,578 |
| ||
Long-term investments |
|
|
|
|
8,102 |
| ||
Deposits and other assets |
|
788 |
|
|
790 |
| ||
Total assets |
$ |
53,985 |
|
$ |
63,724 |
| ||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ |
402 |
|
$ |
1,041 |
| ||
Accrued liabilities |
|
5,199 |
|
|
4,923 |
| ||
Accrued compensation |
|
998 |
|
|
1,892 |
| ||
Deferred revenue |
|
4,700 |
|
|
5,096 |
| ||
Current portion of capital lease obligations |
|
1,172 |
|
|
1,198 |
| ||
Total current liabilities |
|
12,471 |
|
|
14,150 |
| ||
Deferred revenue, less current portion |
|
2,987 |
|
|
3,750 |
| ||
Capital lease obligations, less current portion |
|
1,093 |
|
|
1,081 |
| ||
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, 26,813,004 and 26,558,506 shares issued and outstanding at March 31, 2003 and December 31, 2002, respectively |
|
27 |
|
|
27 |
| ||
Additional paid-in capital |
|
160,684 |
|
|
160,314 |
| ||
Deferred stock-based compensation |
|
(178 |
) |
|
(253 |
) | ||
Accumulated other comprehensive income |
|
71 |
|
|
118 |
| ||
Accumulated deficit |
|
(123,170 |
) |
|
(115,463 |
) | ||
Total stockholders equity |
|
37,434 |
|
|
44,743 |
| ||
Total liabilities and stockholders equity |
$ |
53,985 |
|
$ |
63,724 |
| ||
See accompanying notes
2
CONDENSED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
Three Months Ended March 31, |
||||||||
2003 |
2002 |
|||||||
Revenue |
$ |
1,776 |
|
$ |
3,028 |
| ||
Operating expenses: |
||||||||
Research and development |
|
6,940 |
|
|
8,376 |
| ||
General and administrative |
|
2,571 |
|
|
2,317 |
| ||
Marketing |
|
86 |
|
|
261 |
| ||
Total operating expenses |
|
9,597 |
|
|
10,954 |
| ||
Loss from operations |
|
(7,821 |
) |
|
(7,926 |
) | ||
Interest income, net: |
||||||||
Interest income |
|
215 |
|
|
632 |
| ||
Interest expense |
|
(101 |
) |
|
(89 |
) | ||
Interest income, net |
|
114 |
|
|
543 |
| ||
Net loss |
$ |
(7,707 |
) |
$ |
(7,383 |
) | ||
Basic and diluted net loss per share |
$ |
(0.29 |
) |
$ |
(0.30 |
) | ||
Shares used in computation of basic and diluted net loss per share |
|
26,729 |
|
|
24,983 |
| ||
See accompanying notes
3
CONDENSED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
Three Months Ended March 31, |
||||||||
2003 |
2002 |
|||||||
OPERATING ACTIVITIES: |
||||||||
Net loss |
$ |
(7,707 |
) |
$ |
(7,383 |
) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Depreciation expense |
|
480 |
|
|
423 |
| ||
Non-cash stock-based compensation expense |
|
75 |
|
|
200 |
| ||
Non-cash consulting expense |
|
39 |
|
|
|
| ||
Non-cash interest expense |
|
3 |
|
|
3 |
| ||
Changes in current assets and liabilities |
||||||||
Accounts receivable |
|
1,137 |
|
|
149 |
| ||
Other current assets |
|
689 |
|
|
582 |
| ||
Deposits and other assets |
|
2 |
|
|
|
| ||
Deferred revenue |
|
(1,159 |
) |
|
(1,403 |
) | ||
Accounts payable |
|
(639 |
) |
|
29 |
| ||
Accrued liabilities and compensation |
|
(618 |
) |
|
(1,602 |
) | ||
Net cash used in operating activities |
|
(7,698 |
) |
|
(9,002 |
) | ||
INVESTING ACTIVITIES: |
||||||||
Purchases of investments |
|
(6,606 |
) |
|
(31,054 |
) | ||
Maturities of investments |
|
16,142 |
|
|
51,754 |
| ||
Proceeds from asset disposals |
|
500 |
|
|
|
| ||
Purchases of property and equipment |
|
(330 |
) |
|
(555 |
) | ||
Deferred acquisition costs |
|
(306 |
) |
|
|
| ||
Net cash provided by investing activities |
|
9,400 |
|
|
20,145 |
| ||
FINANCING ACTIVITIES: |
||||||||
Payments on long-term debt |
|
|
|
|
(281 |
) | ||
Payments on capital lease obligations |
|
(266 |
) |
|
(278 |
) | ||
Proceeds from equipment financing arrangement |
|
252 |
|
|
|
| ||
Proceeds from employee stock purchase plan |
|
285 |
|
|
324 |
| ||
Proceeds from exercise of stock options |
|
85 |
|
|
32 |
| ||
Net cash provided by (used in) financing activities |
|
356 |
|
|
(203 |
) | ||
Net increase in cash and cash equivalents |
|
2,058 |
|
|
10,940 |
| ||
Cash and cash equivalents at beginning of year |
|
11,263 |
|
|
13,912 |
| ||
Cash and cash equivalents at period end |
$ |
13,321 |
|
$ |
24,852 |
| ||
See accompanying notes
4
NOTES TO CONDENSED FINANCIAL STATEMENTS (Unaudited)
NOTE 1BUSINESS AND BASIS OF PRESENTATION
Dendreon Corporation, (the Company or Dendreon), founded in 1992, is a Delaware corporation headquartered in Seattle, Washington dedicated to the discovery and development of novel products for the treatment of diseases through innovative manipulation of the immune system. Dendreons product pipeline is focused on cancer, and includes therapeutic vaccines, monoclonal antibodies and small molecule product candidates. The product candidates most advanced in development are therapeutic vaccines that are designed to stimulate a patients immunity for the treatment of cancer.
The accompanying unaudited financial statements reflect, in the opinion of management, all adjustments (consisting only of normal recurring adjustments) necessary for a fair presentation of the Companys 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 the Companys Annual Report on Form 10-K/A for the year ended December 31, 2002. Operating results for the three-month periods ended March 31, 2003 and 2002 are not necessarily indicative of future results that may be expected for the year ending December 31, 2003. Certain reclassifications have been made for consistent presentation.
NOTE 2RECENT ACCOUNTING PRONOUNCEMENTS
In June 2002, the Financial Accounting Standards Board (FASB) issued Statement No. 146, Accounting for Costs Associated with Exit or Disposal Activities. The standard addresses financial accounting and reporting for costs associated with exit or disposal activities and nullifies Emerging Issues Task Force (EITF) Issue No. 94-3, Liability Recognition for Certain Employee Termination Benefits and Other Costs to Exit an Activity (including Certain Costs Incurred in a Restructuring). Statement No. 146 states that a liability for a cost associated with an exit or disposal activity shall be recognized and measured initially at its fair value in the period in which the liability is incurred, except for a liability for one-time termination benefits that are incurred over a period of time. The standard applies to the Company effective for exit and disposal activities initiated after December 31, 2002. The adoption of the standard did not cause a material effect on the Companys operating results or financial conditions.
In November 2002, the FASB issued FASB Interpretation No. 45 (FIN 45), Guarantors Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others, an interpretation of FASB Statements No. 5, 57 and 107 and Rescission of FASB Interpretation No. 34. FIN 45 clarifies the requirements of SFAS No. 5, Accounting for Contingencies, relating to the guarantors accounting for, and disclosure of, the issuance of certain types of guarantees. The disclosure provisions of FIN 45 are effective for financial statements of periods that end after December 15, 2002. However, the provisions for initial recognition and measurement are effective on a prospective basis for guarantees that are issued or modified after December 31, 2002. The adoption of the standard did not cause a material effect on the Companys operating results or financial conditions.
NOTE 3SIGNIFICANT EVENTS
On February 24, 2003, the Company, Seahawk Acquisition, Inc., a wholly-owned subsidiary formed by the Company, Charger Project LLC, also a wholly-owned subsidiary formed by the Company, and Corvas International, Inc., or Corvas, entered into an agreement by which the Company agreed to acquire Corvas. Pursuant to the agreement, Seahawk Acquisition will merge into Corvas, with Corvas surviving as a wholly-owned subsidiary of the Company. Immediately thereafter, Corvas will merge into Charger Project, with Charger Project surviving as a wholly-owned subsidiary of the Company. The completion of the acquisition is subject to several conditions, including the approval of the acquisition by a majority of the outstanding common stock of Corvas and the approval of the issuance of the Companys common stock in the acquisition by a majority of its common stock present or represented at a meeting of the Companys stockholders to approve such issuance.
In connection with the acquisition, each outstanding share of Corvas common stock will be converted into the right to receive 0.45 of a share of the Companys common stock. The Company will assume all options outstanding under Corvas existing stock option plans, and Corvas stock options will be exercisable for the Companys common stock (subject to certain adjustments to the exercise price and number of shares issuable upon exercise of those options). On March 31, 2003, Dendreon and Corvas filed with the Securities and Exchange Commission a Registration Statement on Form S-4 that contains a preliminary joint proxy statement/prospectus with respect to the acquisition and other relevant materials. The transaction is expected to close
5
late in the second quarter of 2003. Unless otherwise indicated, the discussion in this document relates to Dendreon as a stand-alone entity and does not reflect the impact of the proposed acquisition of Corvas.
NOTE 4ACCOUNTING FOR STOCK BASED COMPENSATION
The Company has elected to follow Accounting Principles Board (APB) Opinion No. 25, Accounting for Stock Issued to Employees, and related interpretations, in accounting for employee stock options rather than the alternative fair value accounting allowed by Statement of Financial Accounting Standards (SFAS) No. 123 Accounting for Stock-Based Compensation. Under APB No. 25, compensation expense related to the Companys employee stock options is measured based on the intrinsic value of the stock option. SFAS No. 123, amended by SFAS No. 148 Accounting for Stock-Based Compensation Transition and Disclosure, requires companies that continue to follow APB No. 25 to provide pro forma disclosure of the impact of applying the fair value method of SFAS No. 123. The Company recognizes compensation expense for options granted to non-employees in accordance with the provisions of SFAS No. 123 and the Emerging Issues Task Force consensus Issue 96-18, Accounting for Equity Instruments that are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services, which require using a Black-Scholes option pricing model and re-measuring such stock options to the current fair market value as the underlying option vests.
Deferred stock-based compensation consists of amounts recorded when the exercise price of an option is lower than the subsequently determined fair value of the underlying common stock on the date of grant. Deferred stock-based compensation is amortized over the vesting period of the underlying option using the graded vesting method.
Pro forma information regarding net loss is required by SFAS No. 123 and SFAS No. 148 as if the Company had accounted for its employee stock options under the fair value method. The fair value of the Companys options was estimated at the date of grant using the minimum value method for periods prior to the Companys initial public offering and the Black-Scholes method for subsequent periods, with the following assumptions for the three months ended March 31, 2003 and 2002: no dividend yields; expected lives of the options of four years; risk-free interest rates of 2.4% and 3.0%, respectively; and volatility of 1.27% and 1.28%, respectively. Because the determination of the fair value of the Companys options is based on assumptions described above, and because additional option grants are expected to be made in future periods, this pro forma information is not likely to be representative of the pro forma effects on reported net income or loss for future periods.
For purposes of pro forma disclosures, the estimated fair value of the options is amortized to expense over the options vesting period. The following table illustrates what net loss would have been had the Company accounted for its stock options under the provisions of FAS 123.
Three months ended |
||||||||
2003 |
2002 |
|||||||
(in thousands, except per share data) |
||||||||
Net loss, as reported |
$ |
(7,707 |
) |
$ |
(7,383 |
) | ||
Add: stock based employee compensation expense included in reported net loss |
|
75 |
|
|
200 |
| ||
Deduct: pro forma compensation expense determined |
|
(1,191 |
) |
|
(1,117 |
) | ||
Pro forma net loss |
$ |
(8,823 |
) |
$ |
(8,300 |
) | ||
Basic and diluted net loss per share as reported |
$ |
(0.29 |
) |
$ |
(0.30 |
) | ||
Pro forma and basic and diluted net loss per share |
$ |
(0.33 |
) |
$ |
(0.33 |
) |
6
ITEM 2. | MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
This report contains forward-looking statements that involve risks and uncertainties. The statements contained in this report that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These forward-looking statements concern matters that involve risks and uncertainties that could cause actual results to differ materially from those projected in the forward-looking statements. Words such as believe, expects, likely, may and plans are intended to identify forward-looking statements, although not all forward-looking statements contain these words.
Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. We are under no duty to update any of the forward-looking statements after the date hereof to conform such statements to actual results or to changes in our expectations.
The following discussion should be read in conjunction with the condensed financial statements and the notes thereto included in Item 1 of this Quarterly Report on Form 10-Q. In addition, readers are urged to carefully review and consider the various disclosures made by us which attempt to advise interested parties of the factors which affect our business, including without limitation, Factors That May Affect Our Results of Operations and Financial Condition set forth in this Form 10-Q, and the audited financial statements and the notes thereto and disclosures made under the captions, Managements Discussion and Analysis of Financial Condition and Results of Operations, included in our Annual Report on Form 10-K/A for the year ended December 31, 2002, filed with the Securities and Exchange Commission.
OVERVIEW
Dendreon is dedicated to the discovery and development of novel products for the treatment of diseases through our innovative manipulation of the immune system. Our product pipeline is focused on cancer, and includes therapeutic vaccines, monoclonal antibodies, and small molecule product candidates.
The product candidates most advanced in development are therapeutic vaccines designed to stimulate a patients immune system for the treatment of cancer. Provenge, our therapeutic vaccine for the treatment of prostate cancer, has advanced to Phase 3 clinical trials, the final stage of product development.
We initiated two double-blind, placebo-controlled Phase 3 clinical trials, D9901 and D9902, designed to demonstrate that Provenge is safe and effective for treating androgen independent prostate cancer, or AIPC. Androgen independent means that tumor growth is no longer regulated by androgens, or male hormones, and that the disease has progressed to an advanced stage. Men with prostate cancer that is hormone resistant are considered androgen independent.
The results from our first Phase 3 trial of Provenge, D9901, were announced in August 2002. The results did not meet the primary endpoint of the study, a pre-specified delay in the time to objective disease progression versus placebo in the overall study population. However, the results demonstrated significant benefit from Provenge treatment for men with a Gleason score of 7 or less. For these patients, the probability of remaining progression-free while on the study was over two times higher than for patients treated with placebo. In addition, the patients receiving Provenge whose disease had not progressed six months after randomization had a greater than eight-fold advantage in progression-free survival compared to patients who received placebo. No apparent benefit was observed among patients with Gleason scores of 8 or higher. A Gleason score is the most commonly used prostate cancer scoring system and is considered one of the most important prognostic indicators for prostate cancer. High Gleason scores (8 or above) are indicative of aggressive cancers. In the androgen independent population, approximately 75% of the patients have a Gleason score of 7 or less.
In December 2002, we announced additional results from D9901 indicating that, in addition to delaying the time to progression of disease, Provenge treatment delayed the onset of disease-related pain in patients with a Gleason score of 7 or less. Delay in the onset of disease-related pain was the secondary endpoint of D9901, which enrolled only patients who did not have cancer-related pain at the time of entry into the study. For patients with a Gleason score of 7 or less treated with Provenge, the probability of remaining free of cancer-related pain while on the study was over two-and-one-half times higher than for patients treated with placebo. No apparent benefit in the pain endpoint was observed among patients with Gleason scores of 8 or higher.
7
In light of the results from D9901, we met with the U.S. Food and Drug Administration, or FDA, to discuss our second Phase 3 clinical trial for Provenge, D9902. Based upon those discussions, the protocol for D9902 has been revised and our plan is that the revised D9902 will serve as the pivotal trial for seeking marketing approval for Provenge. The target population for D9902 will be androgen independent prostate cancer patients with a Gleason score of 7 or less whose cancer has spread, but who otherwise are without symptoms.
We are also currently conducting a Phase 3 clinical trial (P-11) of Provenge to evaluate its safety and potential effectiveness in treating men with early stage, androgen dependent prostate cancer. Men with prostate cancer that is hormone sensitive are considered androgen dependent.
In January 2003, we announced that we had developed a novel assay that enables the use of animal models to characterize Provenge, as well as our other cancer immunotherapies. This assay provides a technically easy cell culture system for the analysis of the activity of Provenge. In February 2003, we announced long-term follow-up data from a patient treated with Provenge who had a complete response and experienced a durable remission. This patient, who had advanced, progressive, prostate cancer with PSA levels rising above 200ng/ml while on traditional hormonal treatment, enrolled in one of the Phase 2 trials in our Provenge program and, following treatment, has been disease free for 3.5 years.
We are conducting Phase 2 clinical trials for Mylovenge, our therapeutic vaccine for the treatment of multiple myeloma, and Phase 1 clinical trials for APC8024, our therapeutic vaccine for the treatment of breast, ovarian and colon cancers. We have additional therapeutic vaccines, monoclonal antibodies and small molecule product candidates in preclinical development.
We have incurred significant losses since our inception. As of March 31, 2003, our accumulated deficit was $123.2 million. We have incurred net losses as a result of research and development expenses, general and administrative expenses in support of our operations, clinical trial expenses and marketing expenses. We anticipate incurring net losses over at least the next several years as we continue our clinical trials, apply for regulatory approvals, develop our technology, expand our operations and develop systems that support commercialization.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
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 us to make estimates and judgments in certain circumstances that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent liabilities. In preparing these financial statements, management has made its best estimates and judgments of certain amounts included in the financial statements, giving due consideration to materiality. On an on-going basis, we evaluate our estimates, including those related to revenue recognition, investments, income taxes, financing operations, long-term service contracts, and other contingencies. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances.
Revenue Recognition
Revenue has been derived from our collaborative research and development agreements and from grant awards.
Non-refundable, up-front payments received in connection with collaborative research and development agreements are deferred and recognized on a straight-line basis over the relevant periods specified in the agreement, generally the research term. When the research term is not specified in the agreement and instead the agreement specifies the completion or attainment of a particular development goal, we estimate and recognize the non-refundable upfront payment over the time period required to achieve that goal considering experience with similar projects, level of effort and stage of development. We revise our estimates as additional information becomes available.
Revenue related to research with our corporate collaborators is recognized when research services are performed over the related funding periods for each agreement. Under these agreements, we are required to perform research and development activities as agreed or specified in each agreement. The payments received under research collaboration agreements are not refundable if the research effort is not successful. Payments received in advance of the services provided are deferred and recognized as revenue over the future performance periods.
Milestone payments are recognized based upon the achievement of the specified milestone and as defined in the agreements. Revenue from product supply agreements is recorded when the product is shipped and all obligations under the agreements are met.
As of March 31, 2003 we had deferred revenues of approximately $7.7 million.
8
THREE MONTHS ENDED MARCH 31, 2003 AND 2002
Revenue. Revenue was $1.8 million and $3.0 million for the three months ended March 31, 2003 and 2002, respectively, consisting of collaborative and license revenue. The period over period decrease was primarily due to the expiration of our collaboration agreement with Johnson & Johnson Pharmaceutical Research and Development, LLC on December 31, 2002. Of the $1.8 million, $1.1 million represents deferred revenue from licensing and upfront fees paid by Kirin prior to 2003. Of the remaining balance, $623,000 represents reimbursement from Kirin pursuant to our agreement with Kirin for research and development related to Kirins SART-3 product candidate. Our research and development agreement with Kirin, under which the SART-3 research was conducted, will conclude in October 2003.
Research and Development Expenses. Research and development expenses decreased to $6.9 million for the three months ended March 31, 2003, from $8.4 million for the three months ended March 31, 2002. The period over period decrease of $1.5 million was due to reduced clinical manufacturing and clinical trial costs.
Our research and development-related activities can be divided into two areas:
1) research and pre-clinical programs, and
2) clinical programs.
The costs of the two areas are as follows (in thousands):
Three Months | ||||||
2003 |
2002 | |||||
Research and pre-clinical programs |
$ |
1,554 |
$ |
1,518 | ||
Clinical programs |
|
5,386 |
|
6,858 | ||
Total research and development |
$ |
6,940 |
$ |
8,376 | ||
Research and development costs by project are not tracked on an actual cost basis, but rather are derived by the allocation of third-party costs, personnel-related costs and other overheads to a project based on human resource time incurred in each project. Research and pre-clinical projects primarily represent the costs associated with our product pipeline generating activities, including discovery research projects focused on vaccine, monoclonal antibody and small molecule technologies. The cost of clinical trial programs represents the advancement of the pipeline into product candidates. It is not possible to estimate the time to completion of the clinical trials and their associated total costs as this is dependent on the outcome of each trial event.
General and Administrative Expenses. General and administrative expenses increased to $2.6 million for the three months ended March 31, 2003, from $2.3 million for the three months ended March 31, 2002. The period over period increase in general and administrative expenses was primarily due to increased insurance, accounting and sales tax expenses. Our general and administrative expenses consist primarily of personnel costs for finance, human resources, business development, legal, facilities, information technologies and general management, as well as facility costs and third-party professional fees, such as legal and accounting.
Marketing. Marketing expenses decreased to $86,000 for the three months ended March 31, 2003, from $261,000 for the three months ended March 31, 2002. Our marketing expenses consist primarily of salaries and other personnel-related costs and consulting expenses. The decrease in marketing expense was primarily due to lower spending on medical education and market research.
Interest Income. Interest income decreased to $215,000 for the three months ended March 31, 2003, from $632,000 for the three months ended March 31, 2002. The decrease in 2003 was attributable to lower average balances of cash, cash equivalents, and short- and long-term investments, and a lower average interest rate yield on our investment portfolio.
Interest Expense. Interest expense increased to $101,000 for the three months ended March 31, 2003, from $89,000 for the three months ended March 31, 2002. The increase in 2003 was attributable to a one-time administration fee of $25,000 related to the GE Life Sciences and Technology Financings, a division of General Electric, capital lease line.
LIQUIDITY AND CAPITAL RESOURCES
Cash, cash equivalents and short-term investments were $47.5 million at March 31, 2003. We have financed our operations since inception through our initial and follow-on public offerings, the private placement of equity securities, revenue from collaboration arrangements, grant revenue, interest income earned, equipment lease line financings and loan facilities. We have received net proceeds of $11.1 million from private financing activities since January 1, 2000, and $84.0 million from our initial and follow-on public offerings. To date, inflation has not had a material effect on our business.
9
Since our inception, investing activities, other than purchases and maturities of investments, have consisted primarily of purchases of property and equipment. At March 31, 2003, our investment in equipment and leasehold improvements was $8.7 million. We have an agreement with a financing company under which we have financed purchases of $4.0 million of leasehold improvements, laboratory, computer and office equipment. The lease terms are from 36 to 48 months and bear interest at rates ranging from 8.73% to 14.3% per year. In January 2003, we entered into a $4.0 million lease line with GE Life Sciences and Technology Financings, a division of General Electric. As of March 31, 2003, we had financed $252,000 of leasehold improvements, laboratory, computer and office equipment. The lease terms are 36 months and bear interest at 6.2% per year. The agreement expires on June 30, 2003. We had a tenant improvement allowance of $3.5 million from the lessor of our Seattle, Washington facility. As of March 31, 2003, we had used all of the tenant improvement allowance. The improvement allowance bears interest at the rate of 12.5% per year and is repaid monthly over the length of the original lease.
Net cash used in operating activities for the three months ended March 31, 2003 was $8.0 million. During the three months ended March 31, 2002, we used $9.0 million of net cash in our operating activities. Expenditures in both periods were a result of research and development expenses, general and administrative expenses in support of our operations, and marketing expenses.
The Companys agreement with Shoreline Pacific, LLC, for future financial advisory and consulting services expired in February, 2003. Under the agreement, the Company agreed to pay Shoreline Pacific a fee of a total of 60,000 warrants. Thirty thousand warrants have an exercise price of $2.50 per share, representing the average closing price of the Companys common stock for the four trading days ended on August 12, 2002. The remaining 30,000 warrants will be issued at an exercise price equal to the average per share closing price of the Companys common stock for the fifteen trading days immediately preceding and the fifteen days succeeding and including June 1, 2003. The warrants have been valued using the Black-Scholes valuation method. The resulting fair value of $157,000 was amortized over the six month term of the agreement.
In June 2002, we entered into an equity line financing agreement, or equity line facility, with BNY Capital Markets, Inc., or CMI, a registered broker dealer. As of March 31, 2003, we had issued a total of 206,097 shares at an average price of $4.98 under the equity line facility for gross proceeds of $1,027,000, less issuance costs of $255,000.
On March 31, 2003, Dendreon and Corvas filed with the Securities and Exchange Commission a Registration Statement on Form S-4 that contains a preliminary joint proxy statement/prospectus with respect to the acquisition and other relevant materials. The transaction is expected to close late in the second quarter of 2003. We anticipate at the time of closing that the consolidated companies will have cash, cash equivalents, short and long term investments in excess of $100 million. This estimate is preliminary and may change substantially prior to the completion of the merger.
On January 6, 2003, we filed a shelf registration statement with the SEC to sell up to $75 million of our common stock from time to time. The SEC declared this registration statement effective on January 22, 2003. Under this registration statement, we may sell our common stock:
| directly to purchasers; |
| to or through underwriters or dealers; |
| through agents; or |
| through a combination of such methods. |
In the event that we offer our stock directly to purchasers or to purchasers through agents, the shares may be sold at a single closing and a single price, or at multiple closings and at multiple prices. We expect that the price or prices for any such shares sold in such circumstances will reflect our negotiations with prospective investors, the market price of our common stock, recent trends in the market price of our common stock, other factors considered material by the prospective investors and, if applicable, consultation with any agent involved with the sale or sales. As of March 31, 2003, we have paid to JP Morgan, as private placement agent for us under a proposed private equity offering in the fall of 2002 and the shelf registration statement, the sum of $61,000. We have also paid legal and other accounting fees in the amount of $107,000. To date we have not sold any of our common stock under this shelf registration statement.
Under the terms of our agreement with Corvas, we have agreed to limit drawdowns under our equity line facility with CMI and sales of our common stock under the shelf registration statement to a maximum of $10 million and to effect such drawdowns or sales of stock only at prices at or above the closing price for our common stock on the Nasdaq National Market on February 24, 2003 or $5.79 per share. Unless Corvas agrees otherwise, these limitations will remain in effect until the closing of our acquisition of Corvas or the earlier expiration or termination of the agreement.
We anticipate that our cash on hand and cash generated from our collaboration arrangements will be sufficient to enable us to meet our anticipated expenditures for at least the next 18 months, including, among other things:
| supporting our pivotal Phase 3 trial of Provenge; |
| continuing internal research and development; |
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| manufacturing scale-up and other activities related to the commercialization of Provenge; and |
| preparation of an FDA application for approval of Provenge. |
However, we may need additional financing prior to that time. Additional financing may not be available on favorable terms, or at all. If we are unable to raise additional funds through sales of our common stock under the shelf registration statement, should we need them, or are unable to draw down on our equity line facility when we need to do so because we cannot meet the required conditions or because we are otherwise restricted by the terms of our agreement with CMI from drawing down (for example, each draw down is subject to a minimum closing price per share of $3.00), we may be required to delay, reduce or eliminate some of our development programs and some of our clinical trials.
FACTORS THAT MAY AFFECT OUR RESULTS OF OPERATIONS AND FINANCIAL CONDITION
We have a history of operating losses; we expect to continue to incur losses and we may never be profitable.
As of March 31, 2003, we had an accumulated deficit of $123.2 million. Operating losses have resulted principally from costs incurred in our research and development programs and from our general and administrative expenses in support of our operations, clinical trial expenses, and marketing expenses. We have earned no significant revenues from product sales or royalties. We do not expect to achieve significant product sales or royalty revenue for several years, and we may never do so. We expect to incur additional operating losses in the future and these losses may increase significantly as we continue clinical trials, apply for regulatory approvals, develop our product candidates, expand our operations and develop systems that support commercialization of our potential products.
Our ability to achieve long-term profitability is dependent upon obtaining regulatory approvals for our products and successfully commercializing our products alone or with third parties. We may not be successful in obtaining regulatory approval and commercializing our products, and our operations may not be profitable even if any of our products under development are commercialized.
We may take longer to complete our clinical trials than we project, or we may not be able to complete them at all.
Although for planning purposes we project the commencement, continuation and completion of our clinical trials, a number of factors, including regulatory requirements, scheduling conflicts with participating clinicians and clinical institutions, limits on manufacturing capacity and difficulties in identifying and enrolling patients who meet trial eligibility criteria, may cause significant delays. We may not commence or complete clinical trials involving any of our products as projected or may not conduct them successfully.
We rely on academic institutions, physician practices, and clinical research organizations to conduct, supervise or monitor some or all aspects of clinical trials involving our products. We have less control over the timing and other aspects of these clinical trials than if we conducted the monitoring and supervision entirely on our own. Third-parties may not perform their responsibilities for our clinical trials on our anticipated schedule or consistent with a clinical trial protocol, and may not perform data collection in a timely manner. We rely on clinical research organizations to perform much of our data management and analysis. They may not provide these services as or when required.
If our pivotal trial of Provenge does not proceed as planned or if we fail to complete that clinical trial for any reason, or we otherwise fail to commence or complete, or experience delays in, any of our other present or planned clinical trials, our ability to conduct our business as currently planned could be materially affected. Our development costs will increase if we experience any future delays in our clinical trials for Provenge or in clinical trials for our other potential products or if we need to perform more or larger clinical trials than planned. If the delays or costs are significant, our financial results and our ability to commercialize our product candidates will be adversely affected.
If testing of a particular product candidate does not yield successful results, then we will be unable to commercialize that product.
We must demonstrate the safety and efficacy of our potential products in humans through extensive preclinical and clinical testing. We may experience numerous unforeseen events during, or as a result of, the testing process that could delay or prevent commercialization of our potential products, including the following:
| safety and efficacy results obtained in human clinical trials, as in our Provenge trials, may not be replicated in later clinical trials; |
| the results of preclinical studies may be inconclusive, or they may not be indicative of results that will be obtained in human clinical trials; |
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| after reviewing preclinical testing or human clinical trial results, we or our collaborators may abandon or substantially restructure projects that we might previously have believed to be promising, including Provenge, Mylovenge, APC 8024 and trp-p8; |
| we, our collaborators or regulators may suspend or terminate clinical trials if the participating subjects or patients are being exposed to unacceptable health risks or for other reasons; and |
| the effects of our potential products may not be the desired effects or may include undesirable side effects or other characteristics that preclude regulatory approval or limit their commercial use if approved. |
Clinical testing is very expensive, takes many years, and the outcome is uncertain. D9901, our first Phase III clinical trial for Provenge, did not meet its primary endpoint. Although the analysis identified a group of patients who were benefited by treatment with Provenge, we may not obtain favorable results from the clinical study of more patients in this group in our amended Phase III trial, D9902(B), or those results may cause the FDA to require additional studies. Data from our clinical trials may not be sufficient to support approval by the FDA of our potential products. The clinical trials of Provenge or our other product candidates may not be completed as planned and the FDA may not ultimately approve any of our product candidates for commercial sale. If we fail to adequately demonstrate the safety or efficacy of a product candidate under development, this will delay or prevent regulatory approval of the vaccine, which could prevent us from achieving profitability.
If our products are not accepted by the market, we will not generate significant revenues or become profitable.
The success of any product we may develop will depend upon the medical community, patients and third-party payors accepting our products as medically useful, cost-effective, and safe. We cannot guarantee that any of our products in development, if approved for commercialization, will be used by doctors to treat patients. The degree of market acceptance for our products depends upon a number of factors, including:
| the receipt and scope of regulatory approvals; |
| demonstration of the efficacy and safety of our products to the medical and patient community; |
| the convenience and accessibility of our products for patients; |
| the cost and advantages of our products compared to other available therapies; and |
| reimbursement policies of government and third-party payors. |
We may require additional funding, and our future access to capital is uncertain.
It is expensive to develop cancer vaccines, monoclonal antibodies, small molecules and other products, and to conduct clinical trials for and commercialize them. We plan to continue to simultaneously conduct clinical trials and preclinical research for a number of products, which is costly. Our existing capital and future revenues may not be sufficient to support the expenses of our operations, the development of commercial infrastructure and the conduct of our clinical trials and preclinical research. We may need to raise additional capital to:
| fund operations; |
| continue the research and development of our products; |
| conduct clinical trials; and |
| commercialize our products. |
We believe that our cash on hand and cash generated from our collaborative arrangements will be sufficient to meet our projected operating and capital requirements for at least the next 18 months. However, we may need additional financing within this time frame depending on a number of factors, including the following:
| the rate of progress and cost of our research and development and clinical trial activities; |
| the amount and timing of milestone payments we receive from our collaborators; |
| the costs of developing the processes and systems to support FDA approval of Provenge; |
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| our timetable for and costs of manufacturing scale-up, the development of marketing operations, and other activities related to the commercialization of Provenge; |
| our degree of success in developing Provenge and our other products; |
| the costs of preparing an application for FDA approval of Provenge, if we seek such approval; |
| the emergence of competing technologies and other adverse market developments; and |
| changes in or terminations of our existing collaboration and licensing arrangements. |
We may not be able to obtain additional financing on favorable terms or at all. If we are unable to raise additional funds, we may be required to delay, reduce or eliminate some of our clinical trials and some of our development programs. If we raise additional funds by issuing equity securities, including under our equity line facility or by selling common stock pursuant to our shelf registration statement, further dilution to our existing stockholders may result.
We are subject to extensive regulation, which is costly, time consuming and may subject us to unanticipated delays. Even if we obtain regulatory approval for the commercial sale of any of our products, those products may still face regulatory difficulties.
Our activities, including preclinical studies, clinical trials, cell processing and manufacturing are subject to extensive regulation by the FDA and comparable authorities outside the United States.
Preclinical studies involve laboratory evaluation of product characteristics and animal studies to assess the efficacy and safety of a potential product. The FDA regulates pre-clinical studies under a series of regulations called the current Good Laboratory Practices. If we violate these regulations, the FDA, in some cases, may invalidate the studies and require that we replicate those studies.
An investigational new drug application, or IND, must become effective before human clinical trials may commence. The investigational new drug application is automatically effective 30 days after receipt by the FDA unless, before that time, the FDA requests an extension to review the application, or raises concerns or questions about the design of the trials as described in the application. In the latter case, we must resolve any outstanding concerns with the FDA before clinical trials can proceed. Thus, the submission of an investigational new drug application may not result in the FDA authorizing us to commence clinical trials in any given case. After such authorization is received, the FDA retains authority to place the IND, and clinical trials under that IND, on clinical hold.
We and third parties on whom we rely to assist us with clinical trials, are subject to extensive regulation by the FDA in the design and conduct of those trials. Also, investigational products in clinical trials must be manufactured in accordance with a series of complex regulations called current Good Manufacturing Practice, or cGMP. Other products used in connection with our clinical trials must be manufactured in accordance with regulations called the Quality Systems Regulations, or QSR. These regulations govern manufacturing processes and procedures and the implementation and operation of quality systems to control and assure the quality of our investigational products. We and third parties with whom we contract for manufacturing and cell processing must comply with cGMP or QSR, as applicable. Our facilities and quality systems and the facilities and quality systems of our third party collaborators must pass a pre-approval inspection for compliance with the applicable regulations as a condition of FDA approval of Provenge or any of our other potential products. In addition, the FDA may, at any time, audit one of our clinical trials or audit or inspect a manufacturing or cell processing facility involved with the production of Provenge or one of our other potential products or the associated quality systems for compliance with the regulations applicable to the activities being conducted. If any such inspection or audit identifies noncompliance with applicable regulations, the FDA may require remedial measures that are costly and/or time consuming for us or a third-party to implement and that may include the temporary or permanent suspension of a clinical trial or temporary or permanent closure of a facility. The FDA may also disqualify a clinical trial in whole or in part from consideration in support of approval of a potential product for commercial sale or otherwise deny approval of that product. Any such remedial measures imposed upon us or third parties with whom we contract could harm our business.
The process of obtaining required FDA and other regulatory approvals, including foreign approvals, is expensive, often takes many years, and can vary substantially based upon the type, complexity and novelty of the products involved. Provenge and our other vaccine products are novel; therefore, regulatory agencies lack experience with them, which may lengthen the regulatory review process, increase our development costs and delay or prevent commercialization of Provenge and our other products under development.
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To date, no cancer vaccine using antigen-presenting cell technologies has been approved for commercial sale in the United States. Consequently, there is no precedent for the successful commercialization of products based on our technologies. In addition, we have had only limited experience in filing and pursuing the applications necessary to gain regulatory approvals for commercial sale, which may impede our ability to obtain FDA approvals. We have not yet sought FDA approval for any vaccine product. We will not be able to commercialize any of our potential products until we obtain FDA approval. Therefore, any delay in obtaining, or inability to obtain, FDA approval could harm our business.
If we are not in compliance with regulatory requirements at any stage, including post-marketing approval, we may be fined, forced to remove a product from the market and experience other adverse consequences, including delay, which could materially harm our financial results. Additionally, we may not be able to obtain the labeling claims necessary or desirable for the promotion of our products. We may also be required to undertake post-marketing clinical trials. If the results of such post-marketing studies are not satisfactory, marketing authorization can be withdrawn or continued marketing conditioned on commitments from us that may be expensive and/or time consuming to fulfill. In addition, if we or others identify side effects after any of our products are on the market, or if manufacturing problems occur, regulatory approval may be withdrawn and reformulation of our products, additional clinical trials, changes in labeling of our products, and additional marketing applications may be required.
The availability and amount of reimbursement for our potential products and the manner in which government and private payors may reimburse for our potential products is uncertain; we may face challenges from government and private payors that adversely affect reimbursement for our potential products.
We expect that many of the patients who seek treatment with our products, if they are approved for marketing, will be eligible for Medicare benefits. Other patients may be covered by private health plans or uninsured. The application of existing Medicare regulations and interpretive rulings to newly-approved products, especially novel products such as ours, is not certain and those regulations and interpretive rulings are subject to change. If we are unable to obtain or retain adequate levels of reimbursement from Medicare or from private health plans, our ability to sell our potential products will be adversely affected. Medicare regulations and interpretive rulings also may determine who may be reimbursed for certain services. This may adversely affect our ability to market or sell our potential products, if approved.
Federal and state governments, and foreign governments as well, continue to propose legislation designed to contain or reduce health care costs. Legislation and regulations affecting the pricing of products like our potential products may change or be adopted before any of our potential products are approved for marketing. Cost control initiatives could decrease the price that we receive for any one or all of our potential products or increase patient coinsurance to a level that makes our products under development unaffordable. In addition, government and private health plans persistently challenge the price and cost-effectiveness of therapeutic products. Therefore, any one or all of our products under development may ultimately not be considered cost-effective by these third-party payors and thus may not be covered under their health plans or covered only at a lower price. Any of these initiatives or developments could prevent us from successfully marketing and selling any of our potential products.
We rely on third parties to perform a variety of functions and have limited manufacturing and cell processing capabilities, which could limit our ability to commercialize our products.
We rely in part on collaborators and other third parties to perform for us or assist us with a variety of important functions, including research and development, cell processing, manufacturing and clinical trials management. We also license technology from others to enhance or supplement our technologies. We have never manufactured our cancer vaccines and other potential products on a commercial scale. It may be difficult or impossible to economically manufacture our products on a commercial scale. We have contracted with Diosynth RTP, Inc. to assist us in the scale-up to commercial level production of the antigen used in the preparation of Provenge. We cannot be certain that the contemplated scale-up will be successful or that it will proceed on the planned timetable. An inability to scale-up the production of the antigen used in Provenge or delay in achieving such scale-up will adversely affect our business.
We intend to rely on third party contract manufacturers to produce large quantities of materials needed for clinical trials and product commercialization. Third party manufacturers may not be able to meet our needs with respect to timing, quantity or quality. If we are unable to contract for a sufficient supply of needed materials on acceptable terms, or if we should encounter delays or difficulties in our relationships with manufacturers, our submission of products for regulatory approval or the market introduction and subsequent sales of our products may be delayed. Any delay may lower our revenues and potential profitability and adversely affect our stock price.
We operate a facility for cell processing and the manufacture of antigens for our clinical trials. We also contract with third parties to provide these services. These facilities may not be sufficient to meet our needs for our Provenge and other clinical
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trials. Additionally, if we decide to manufacture any of our potential products in commercial quantities ourselves, we will require substantial additional funds and will be required to hire and train a significant number of employees, construct additional facilities and comply with applicable regulations for these facilities, which are extensive. We may not be able to develop production facilities that both meet regulatory requirements and are sufficient for our clinical trials or for commercial use.
If we lose or are unable to secure collaborators, or if our collaborators, including Kirin and Genentech, do not apply adequate resources to their collaborations with us, our product development and potential for profitability may suffer.
We intend to continue to enter into collaborations for one or more of the research, development, manufacturing, marketing and other commercialization activities relating to some of our products under development. We have entered into a collaboration with Kirin relating to the development and commercialization in Asia of our products based on our antigen-presenting cell technologies. As our collaborator, Kirin funds testing, makes regulatory filings and may manufacture and market our licensed products in Asia. We have also entered into a collaboration with Genentech for preclinical research, clinical development, and commercialization of monoclonal antibodies and potentially other products derived from our trp-p8 gene platform. The amount and timing of resources applied by Kirin or Genentech or other potential collaborators to our joint efforts are not within our control.
If any collaborator breaches or terminates its agreement with us, or fails to conduct its collaborative activities in a timely manner, the commercialization of our products under development could be slowed down or blocked completely. It is possible that Kirin, Genentech or other potential collaborators will change their strategic focus, pursue alternative technologies or develop alternative products, either on their own or in collaboration with others, to treat the diseases targeted by our collaborative programs. It is also possible that a collaborator may conduct a clinical trial or other activities with respect to one or more of our potential products which has results or consequences that reflect adversely upon that product and harm our ability to develop that product or obtain FDA approval for its commercial sale. The effectiveness of our collaborators in marketing our products will also affect our revenues and earnings.
Our collaborations with Kirin and Genentech may not continue or be successful and we may not receive any further research funding, milestone or royalty payments. We recognized approximately 58% and 36% of our revenue in 2002 and 2001, respectively, from our collaboration with Kirin. We intend to continue to enter into new collaborative agreements in the future. However, we may not be able to successfully negotiate any additional collaborative arrangements. If established, these relationships may not be scientifically or commercially successful. Any additional collaborations would likely subject us to some or all of the risks described above with respect to our collaborations with Kirin and Genentech. Disputes may arise between us and our existing or potential future collaborators as to a variety of matters, including financial or other obligations under our agreements. These disputes may be both expensive and time-consuming and may result in delays in the development and commercialization of products.
We are dependent on single source vendors for some of our components.
We currently depend on single-source vendors for some of the components necessary for our vaccine candidates, such as cell culture media. There are, in general, relatively few alternative sources of supply for these products. While these vendors have produced our products with acceptable quality, quantity and cost in the past, they may be unable or unwilling to meet our future demands. Establishing additional or replacement suppliers for these products could take a substantial amount of time. If we have to switch to a replacement vendor, the manufacture and delivery of our vaccines could be interrupted for an extended period.
If we are unable to protect our proprietary rights, we may not be able to compete effectively or operate profitably.
Our success is dependent in part on obtaining, maintaining and enforcing our patents and other proprietary rights and our ability to avoid infringing the proprietary rights of others. Patent law relating to the scope of claims in the biotechnology field in which we operate is still evolving and, consequently, patent positions in our industry may not be as strong as in other more well-established fields. Accordingly, the United States Patent and Trademark Office may not issue patents from the patent applications owned by or licensed to us. If issued, the patents may not give us an advantage over competitors with similar technology. It is also possible that third parties may successfully avoid our patents through design innovation.
The issuance of a patent is not conclusive as to its validity or enforceability and it is uncertain how much protection, if any, will be given to our patents if we attempt to enforce them and their validity is challenged in court or in other proceedings, such as oppositions, which may be brought in domestic or foreign jurisdictions. A third party may challenge the validity or enforceability of a patent after its issuance by the United States Patent and Trademark Office. It is possible that a third party may successfully challenge our patents or patents licensed by us from others, or that a challenge will result in limiting the coverage of our patents. The cost of litigation to uphold the validity of patents and to prevent infringement can be substantial and, if the outcome of
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litigation is adverse to us, third parties may be able to use our patented invention without payment to us. Moreover, it is possible that third parties may infringe our patents. To stop these activities we may need to file a lawsuit. Even if we were successful in stopping the violation of our patent rights, these lawsuits are very expensive and consume time and other resources. In addition, there is a risk that a court would decide that our patents are not valid and that we do not have the right to stop the other party from using the invention. There is also the risk that, even if the validity of our patents is upheld, a court will refuse to stop the other party on the grounds that its activities are not covered by, that is, do not infringe, our patents.
In addition to the intellectual property rights described above, we also rely on unpatented technology, trade secrets and confidential information. Therefore, others may independently develop substantially equivalent information and techniques or otherwise gain access to or disclose our technology. We may not be able to effectively protect our rights in unpatented technology, trade secrets and confidential information. We require each of our officers, employees, consultants and advisors, and our manufacturers and vendors, as appropriate, to execute a confidentiality agreement at the commencement of an employment or consulting relationship with us. However, these agreements may not provide effective protection of our information or, in the event of unauthorized use or disclosure, they may not provide adequate remedies.
The use of our technologies could potentially conflict with the rights of others.
Our competitors or others may have or acquire patent rights that they could enforce against us. If they do so, then we may be required to alter our products, pay licensing fees or cease activities. If our products conflict with patent rights of others, third-parties could bring legal actions against us claiming damages and seeking to enjoin manufacturing and marketing of the affected products. If these legal actions are successful, in addition to any potential liability for damages, we could be required to obtain a license in order to continue to manufacture or market the affected products. We may not prevail in any legal action and a required license under the patent may not be available on acceptable terms or at all.
We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights.
The cost to us of any litigation or other proceeding relating to intellectual property rights, even if resolved in our favor, could be substantial. Some of our competitors may be better able to sustain the costs of complex patent litigation because they have substantially greater resources. If there is litigation against us, we may not be able to continue our operations.
Should third parties file patent applications, or be issued patents claiming technology also claimed by us in pending applications, we may be required to participate in interference proceedings in the United States Patent and Trademark Office to determine priority of invention. We may be required to participate in interference proceedings involving our issued patents and pending applications. We may be required to cease using the technology or to license rights from prevailing third parties as a result of an unfavorable outcome in an interference proceeding. A prevailing party in that case may not offer us a license on commercially acceptable terms, or at all.
We are exposed to potential product liability claims, and insurance against these claims may not be available to us at a reasonable rate in the future.
Our business exposes us to potential product liability risks which are inherent in the testing, manufacturing, marketing and sale of pharmaceutical products. We have clinical trial insurance coverage and we intend to obtain product liability insurance coverage in the future. However, this insurance coverage may not be available to us at an acceptable cost, if at all. We may not be able to obtain future insurance coverage that will be adequate to satisfy any liability that may arise. Regardless of their merit or eventual outcome, product liability claims may result in decreased demand for a product, injury to our reputation, withdrawal of clinical trial volunteers and loss of revenues. Thus, whether or not we are insured, a product liability claim or product recall may result in losses that could be material.
Competition in our industry is intense, and many of our competitors have substantially greater resources than we do.
Competition in the cancer and autoimmune disease fields is intense and is accentuated by the rapid pace of technological development. Research and discoveries by others may result in breakthroughs which may render our products obsolete even before they generate any revenue. There are products currently under development by others that could compete with the products that we are developing. Many of our competitors have substantially greater research and development capabilities and manufacturing, marketing, financial and managerial resources than we do. Our competitors may:
| develop safer or more effective therapeutics vaccines and other therapeutic products; |
| reach the market more rapidly, reducing the potential sales of our products; or |
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| establish superior proprietary positions. |
We understand that companies, including AVI BioPharma, Inc., Cell Genesys, Inc., and Therion Biologics Corporation, may be developing prostate cancer vaccines that could potentially compete with Provenge, if Provenge is successfully developed. Other products such as chemotherapeutics, antisense compounds, angiogenesis inhibitors, and gene therapies are also under development and could potentially compete with Provenge.
We anticipate that we will face increased competition in the future as new companies enter our markets and as scientific developments surrounding therapeutic vaccines and other cancer therapies accelerate. If our products receive marketing approval but cannot compete effectively in the marketplace, our profitability and financial position would suffer.
We must expand our operations to commercialize our products, which we may not be able to do.
We will need to expand and effectively manage our operations and facilities to successfully pursue and complete future research, development and commercialization efforts. To grow, we will need to add personnel and expand our capabilities, which may strain our existing managerial, operational, financial and other resources. To compete effectively and manage our growth, we must:
| train, manage and motivate our employees; |
| accurately forecast demand for our products; |
| expand existing operational, financial and management information systems; and |
| hire sufficient sales force to generate revenue. |
If we fail to manage our growth effectively, our product development and commercialization efforts could be curtailed or delayed.
If we lose key management and scientific personnel or cannot recruit qualified employees, our product development programs and our research and development efforts will be harmed.
Our success depends, to a significant extent, upon the efforts and abilities of our key employees. The loss of the services of one or more of our key employees may delay our product development programs and our research and development efforts. We do not maintain key person life insurance on any of our officers, employees or consultants.
Competition for qualified employees among companies in the biotechnology and biopharmaceutical industry is intense. Our future success depends upon our ability to attract, retain and motivate highly skilled employees. In order to commercialize our products successfully, we may be required to expand our workforce substantially, particularly in the areas of manufacturing, clinical trials management, quality, regulatory affairs, business development and sales and marketing. These activities will require the addition of new personnel, including management, and the development of additional expertise by existing management personnel.
Market volatility may affect our stock price and the value of an investment in our common stock may be subject to sudden decreases.
The trading price for our common stock has been, and we expect it to continue to be, volatile. The price at which our common stock trades depends upon a number of factors, including our historical and anticipated operating results, preclinical and clinical trial results, market perception of the prospects for biotechnology companies as an industry sector and general market and economic conditions, some of which are beyond our control. Factors such as fluctuations in our financial and operating results, changes in government regulations affecting product approvals, reimbursement or other aspects of our or our competitors businesses, FDA review of our product development activities, the results of preclinical studies and clinical trials, announcements of technological innovations or new commercial products by us or our competitors, developments concerning key personnel and our intellectual property rights, significant collaborations or strategic alliances and publicity regarding actual or potential performance of products under development by us or our competitors could also cause the market price of our common stock to fluctuate substantially. In addition, the stock market has from time to time experienced extreme price and volume fluctuations. These broad market fluctuations may lower the market price of our common stock. Moreover, during periods of stock market price volatility, share prices of many biotechnology companies have often fluctuated in a manner not necessarily related to their
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individual operating performance. Accordingly, our common stock may be subject to greater price volatility than the stock market as a whole.
Anti-takeover provisions in our charter documents and under Delaware law and our stockholders rights plan could make an acquisition of us, which may be beneficial to our stockholders, more difficult.
Provisions of our certificate of incorporation and bylaws will make it more difficult for a third-party to acquire us on terms not approved by our board of directors and may have the effect of deterring hostile takeover attempts. For example, our certificate of incorporation currently authorizes our board of directors to issue up to 10,000,000 shares of preferred stock, of which 1,000,000 shares have been designated as Series A Junior Participating Preferred Stock, and to fix the price, rights, preferences, privileges and restrictions, including voting rights, of those shares without any further vote or action by the stockholders. The rights of the holders of our common stock will be subject to, and may be harmed by, the rights of the holders of any preferred stock that may be issued in the future. The issuance of preferred stock could reduce the voting power of the holders of our common stock and the likelihood that common stockholders will receive payments upon liquidation. In addition, our certificate of incorporation divides our board of directors into three classes having staggered terms. We are also subject to provisions of Delaware law that could have the effect of delaying, deferring or preventing a change in control of our company. One of these provisions prevents us from engaging in a business combination with any interested stockholder for a period of three years from the date the person becomes an interested stockholder, unless specified conditions are satisfied. We have also implemented a stockholders rights plan, also called a poison pill, that would substantially reduce or eliminate the expected economic benefit to an acquirer from acquiring us in a manner or on terms not approved by our board of directors. These and other impediments to a third-party acquisition or change of control could limit the price investors are willing to pay in the future for shares of our common stock.
Our executive officers, directors and principal stockholders have substantial control over us, which could delay or prevent a change in our corporate control favored by our other stockholders.
As of April 24, 2003, our executive officers, directors and principal stockholders beneficially owned approximately 36.7% of our outstanding common stock. These stockholders will likely continue to exercise substantial influence over us for the foreseeable future, even if we should issue common stock pursuant to our shelf registration statement or under our equity line facility. Accordingly, these stockholders, individually and as a group, may be able to control us and direct our officers and business, including any determination with respect to a change in control, future issuances of our common stock or other securities, declarations of dividends on our common stock and the election of our board of directors.
If registration rights that we have previously granted are exercised, then our stock price may be negatively affected.
We have granted registration rights in connection with the issuance of our securities to a number of our principal stockholders and warrant holders. In the aggregate, as of December 31, 2002, these registration rights covered approximately 8,822,725 shares of our common stock which were then outstanding and an additional 423,189 shares of our common stock which may become outstanding upon the exercise of warrants that were then outstanding. If these registration rights, or similar registration rights that may apply to securities we may issue in the future, are exercised by the holders, it could result in additional sales of our common stock in the market, which may have an adverse effect on our stock price.
Our issuance of shares under our equity line facility and in connection with our proposed acquisition of Corvas will dilute the equity ownership of our existing stockholders.
Under our equity line financing agreement with BNY Capital Markets, Inc., or CMI, we may, at our option and subject to the satisfaction of specified conditions, issue to CMI an aggregate of up to 4,593,903 shares of our common stock from time to time through June 11, 2004. The precise number of shares of our common stock that we will issue to CMI over the remaining term of the equity line financing agreement will depend primarily on the number of drawdowns we choose to undertake, the amounts of those drawdowns and the closing market price of our common stock during the drawdown periods. In addition, we estimate that we will issue approximately 12.4 million shares of common stock in connection with our proposed acquisition of Corvas, and that immediately thereafter former Corvas stockholders will hold approximately 31.7% of the then-outstanding shares of our common stock, based on the number of shares of Dendreon and Corvas common stock outstanding as of March 25, 2003. Each of our issuances of common stock to CMI under the equity line facility and to Corvas shareholders upon completion of the proposed acquisition will proportionately decrease our existing stockholders percentage ownership of our total outstanding equity interests.
If we fail to complete our acquisition of Corvas International, then we will have incurred significant expenses without realizing the expected benefits.
We cannot be certain that we will complete our acquisition of Corvas. The closing of the acquisition is subjection to a number of conditions, some of which are outside our control, including the approval of the transaction by the shareholders of both Dendreon and Corvas and the non-occurrence of any event or condition that would have a material adverse effect on either Corvas or us. Failure to complete the acquisition could have a material adverse impact on our results of operations and financial condition because we would have incurred significant transaction-related expenses without realizing the expected benefits of the transaction, including the acquisition of Corvas cash, cash equivalents and investments.
Transactions by CMI may adversely affect the price of our common stock.
From time to time during drawdown periods, within limitations specified in our equity line facility with CMI and subject to applicable laws, CMI may engage in hedging and other transactions in our common stock, and may sell and deliver shares of our common stock issued under the equity line facility in connection with these transactions. If CMI engages in such transactions, the price of our common stock may be adversely affected.
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The actual or anticipated sale by us of common stock under our shelf registration statement or resale by CMI of shares of our common stock that it purchases from us under the equity line facility or otherwise owns or acquires may have an adverse impact on the market price of our common stock.
The sale by us of common stock under our shelf registration statement or resale by CMI of the common stock that it purchases from us under the equity line facility or that it otherwise owns or acquires may, depending upon the timing of the resales, depress the market price of our common stock. Moreover, as all the shares we sell under our shelf registration statement or to CMI will be available for immediate resale, the mere prospect of such sales could depress the market price of our common stock. In addition, actual or anticipated downward pressure on the market price of our common stock due to actual or anticipated sales under the shelf registration statement or resales of our common stock by CMI could cause some institutions or individuals to engage in short sales of our common stock, which may itself cause the market price of our common stock to decline.
ITEM 3. QUALITATIVE AND QUANTITATIVE DISCLOSURES ABOUT MARKET RISK
As of March 31, 2003, we had short-term investments of $34.1 million. Our short-term investments will decline by an immaterial amount if market interest rates increase, and therefore, our exposure to interest rate changes has been immaterial. Declines of interest rates over time will, however, reduce our interest income from our short-term investments. Our outstanding capital lease obligations are all at fixed interest rates and therefore have minimal exposure to changes in interest rates.
ITEM 4. CONTROLS AND PROCEDURES
(a) | Within the 90-day period prior to the filing date of this report, the Company carried out an evaluation, under the supervision and with the participation of the Companys management, including the Companys Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of the Companys disclosure controls and procedures pursuant to Rule 13a-14 of the Securities Exchange Act of 1934 (the Exchange Act). Based upon the evaluation, the Chief Executive Officer and Chief Financial Officer concluded that the Companys disclosure controls and procedures are effective in timely alerting them to material information relating to the Company required to be included in the Companys Exchange Act filings. |
(b) | There have been no significant changes in the Companys internal controls or in other factors which could significantly affect internal controls subsequent to the date the Company carried out its evaluation. |
PART IIOTHER INFORMATION
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) | Exhibits |
Exhibit Number |
Description | |
2.1 |
Agreement and Plan of Merger, dated as of February 24, 2003, by and among the Company, Seahawk Acquisition, Inc., Charger Project LLC, and Corvas International, Inc. (1) | |
3.1 |
Amended and Restated Certificate of Incorporation (2) | |
3.2 |
Amended and Restated Bylaws (3) | |
3.3 |
Certificate of Designation of Series A Junior Participating Preferred Stock (4) | |
4.1 |
Specimen Common Stock certificate (5) | |
4.2 |
Registration Rights Agreement dated as of June 11, 2002, between the Company and BNY Capital Markets, Inc. (6) | |
4.3 |
Rights Agreement between Dendreon Corporation and Mellon Investor Services, as Rights Agent, dated as of September 18, 2002 (4) | |
10.1 |
Form of Lockup and Voting Agreement dated as of February 24, 2003 between Corvas International, Inc. and certain officers, directors and stockholders of the Company (1) | |
10.2 |
Form of Lockup and Voting Agreement dated as of February 24, 2003 between the Company and certain officers, directors and stockholders of Corvas International, Inc. (1) |
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(1) | Filed as an exhibit to the Companys Current Report on Form 8-K, filed with the Securities and Exchange Commission on February 25, 2002, File No. 000-30681. |
(2) | Filed as an exhibit to the Companys Quarterly Report on Form 10-Q for the quarter ended March 31, 2002, File No. 000-30681. |
(3) | Filed as an exhibit to the Companys Registration Statement on Form S-1, File No. 333-31920, as filed on March 8, 2000. |
(4) | Filed as an exhibit to the Companys Current Report on Form 8-K, filed with the Securities and Exchange Commission on September 25, 2002, File No. 000-30681. |
(5) | Filed as an exhibit to the Companys Registration Statement on Form S-1/A, File No. 333-31920, as filed on May 22, 2000. |
(6) | Filed as an exhibit to the Companys current Report on Form 8-K filed with the Securities and Exchange Commission on June 13, 2002, File No. 000-30681. |
(b) | Reports on Form 8-K. |
The Company filed a Current Report on Form 8-K on February 25, 2003 (File No. 000-30681) announcing that it had entered into an Agreement and Plan of Merger on February 24, 2003 with Corvas International, Inc.
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Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Dated this 1st day of May, 2003
DENDREON CORPORATION
| ||
By: |
/s/ MARTIN A. SIMONETTI | |
Martin A. Simonetti Senior Vice President, Finance Chief Financial Officer and Treasurer (Principal Financial and Accounting Officer and Duly Authorized Officer) |
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I, Mitchell H. Gold, M.D., certify that:
1. I have reviewed this quarterly report on Form 10-Q of Dendreon Corporation;
2. Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;
3. Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;
4. The registrants other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have:
a) designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;
b) evaluated the effectiveness of the registrants disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the Evaluation Date); and
c) presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date;
5. The registrants other certifying officers and I have disclosed, based on our most recent evaluation, to the registrants auditors and the audit committee of registrants board of directors (or persons performing the equivalent function):
a) all significant deficiencies in the design or operation of internal controls which could adversely affect the registrants ability to record, process, summarize and report financial data and have identified for the registrants auditors any material weaknesses in internal controls; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal controls; and
6. The registrants other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.
Date: May 1, 2003
/s/ MITCHELL H. GOLD, M.D. |
Mitchell H. Gold, M.D. Chief Executive Officer |
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Certification
I, Martin A. Simonetti, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Dendreon Corporation;
2. Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;
3. Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;
4. The registrants other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have:
a) designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;
b) evaluated the effectiveness of the registrants disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the Evaluation Date); and
c) presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date;
5. The registrants other certifying officers and I have disclosed, based on our most recent evaluation, to the registrants auditors and the audit committee of registrants board of directors (or persons performing the equivalent function):
a) all significant deficiencies in the design or operation of internal controls which could adversely affect the registrants ability to record, process, summarize and report financial data and have identified for the registrants auditors any material weaknesses in internal controls; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal controls; and
6. The registrants other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.
Date: May 1, 2003
/s/ MARTIN A. SIMONETTI |
Martin A. Simonetti Senior Vice President, Finance Chief Financial Officer and Treasurer |
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CERTIFICATION
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, Mitchell H. Gold, M.D., the Chief Executive Officer of Dendreon Corporation (the Company), and Martin A. Simonetti, the Chief Financial Officer of the Company, each hereby certifies that, to the best of his knowledge:
1. The Companys Quarterly Report on Form 10-Q for the period ended March 31, 2003, to which this Certification is attached as Exhibit 99.1 (the Periodic Report), fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934, as amended; and
2. The information contained in the Periodic Report fairly presents, in all material respects, the financial condition of the Company at the end of the period covered by the Periodic Report and results of operations of the Company for the period covered by the Periodic Report.
Dated: May 1, 2003
/s/ MITCHELL H. GOLD, M.D. |
/s/ MARTIN A. SIMONETTI | |||
Mitchell H. Gold, M.D. Chief Executive Officer |
Martin A. Simonetti Chief Financial Officer |
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Exhibit Number |
Description | |
2.1 |
Agreement and Plan of Merger dated as of February 24, 2003 between the Company and Corvas International, Inc. (1) | |
3.1 |
Amended and Restated Certificate of Incorporation (2) | |
3.2 |
Bylaws (3) | |
3.3 |
Certificate of Designation of Series A Junior Participating Preferred Stock (4) | |
4.1 |
Specimen Common Stock certificate (3) | |
4.2 |
Registration Rights Agreement dated as of June 11, 2002, between the Company and BNY Capital Markets, Inc. (3), (5) | |
4.4 |
Rights Agreement between Dendreon Corporation and Mellon Investor Services, as Rights Agent, dated as of September 18, 2002 (4) | |
10.1 |
Form of Lockup and Voting Agreement dated as of February 24, 2003 between Corvas International, Inc. and certain officers, directors and stockholders of the Company (1) | |
10.2 |
Form of Lockup and Voting Agreement dated as of February 24, 2003 between the Company and certain officers, directors and stockholders of Corvas International, Inc. (1) |
(1) | Filed as an exhibit to the Companys Current Report on Form 8-K, filed with the Securities and Exchange Commission on February 25, 2002, File No. 000-30681. |
(2) | Filed as an exhibit to the Companys Quarterly Report on Form 10-Q for the quarter ended March 31, 2002, File No. 000-30681. |
(3) | Filed as an exhibit to Registration Statement on Form S-1, File No. 333-31920. |
(4) | Filed as an exhibit to the Companys Current Report on Form 8-K, filed with the Securities and Exchange Commission on September 25, 2002, File No. 000-30681. |
(5) | Filed as an exhibit to the Companys current Report on Form 8-K filed with the Securities and Exchange Commission on June 13, 2002, File No. 000-30681. |
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