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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 


 

FORM 10-Q

 

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2004

 

or

 

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

FOR THE TRANSITION PERIOD FROM                  TO                 

 


 

Commission File Number: 000-30681

 

DENDREON CORPORATION

(Exact name of registrant as specified in its charter)

 

DELAWARE   22-3203193
(State or other jurisdiction of incorporation or organization)   (IRS Employer Identification No.)

 

3005 FIRST AVENUE, SEATTLE, WASHINGTON 98121

(Address of principal executive offices, including zip code)

 

(206) 256-4545

(Registrant’s telephone number, including area code)

 

www.dendreon.com

 


 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. x Yes ¨ No

 

Indicate by check mark whether the registrant (1) is an accelerated filer (as defined in Rule 12b-2 of the Act). x Yes ¨ No

 

The number of shares of the registrant’s common stock, $.001 par value, outstanding as of May 7, 2004 was 57,761,979.

 



DENDREON CORPORATION

 

INDEX

 

               PAGE NO.

PART I.

   FINANCIAL INFORMATION     
     Item 1.    Financial Statements    2
         

a) Consolidated Balance Sheets as of March 31, 2004 (unaudited) and December 31, 2003

   2
         

b) Consolidated Statements of Operations for the Three Months Ended March 31, 2004 and 2003 (unaudited)

   3
         

c) Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2004 and 2003 (unaudited)

   4
         

d) Notes to Consolidated Financial Statements (unaudited)

   5
     Item 2.    Management’s Discussion and Analysis of Financial Condition and Results of Operations    9
     Item 3.    Qualitative and Quantitative Disclosures About Market Risk    26
     Item 4.    Controls and Procedures    26

PART II.

   OTHER INFORMATION     
     Item 1.    Legal Proceedings    27
     Item 6.    Exhibits and Reports on Form 8-K    27

SIGNATURES

   28

EXHIBIT INDEX

    

 


PART I—FINANCIAL INFORMATION

 

ITEM 1. FINANCIAL STATEMENTS

 

DENDREON CORPORATION

 

CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share amounts)

 

     March 31,
2004


    December 31,
2003


 
     (Unaudited)        
ASSETS                 

Current assets:

                

Cash and cash equivalents

   $ 85,118     $ 44,349  

Short-term investments

     116,104       55,692  

Accounts receivable

     5,692       5,689  

Other current assets

     3,867       2,974  
    


 


Total current assets

     210,781       108,704  

Property and equipment, net

     3,879       5,011  

Long-term investments

     42,255       13,150  

Restricted cash

     303       303  

Receivable, net of current portion

     10,259       9,943  

Deposits and other assets

     728       734  
    


 


Total assets

   $ 268,205     $ 137,845  
    


 


LIABILITIES AND STOCKHOLDERS’ EQUITY                 

Current liabilities:

                

Accounts payable

   $ 352     $ 1,221  

Accrued liabilities

     10,428       8,473  

Accrued compensation

     1,539       4,976  

Deferred revenue

     103       107  

Current portion of capital lease obligations

     1,424       1,463  
    


 


Total current liabilities

     13,846       16,240  

Deferred revenue, less current portion

     703       725  

Capital lease obligations, less current portion

     1,344       899  

Deferred foreign tax

     1,041       994  

Stockholders’ equity:

                

Preferred stock, $0.001 par value; 10,000,000 shares authorized, no shares issued or outstanding

     —         —    

Common stock, $0.001 par value; 80,000,000 shares authorized, 57,737,455 and 44,926,284 shares issued and outstanding at March 31, 2004 and December 31, 2003, respectively

     58       45  

Additional paid-in capital

     408,439       263,610  

Deferred stock-based compensation

     (285 )     (651 )

Accumulated other comprehensive loss

     (20 )     (61 )

Accumulated deficit

     (156,921 )     (143,956 )
    


 


Total stockholders’ equity

     251,271       118,987  
    


 


Total liabilities and stockholders’ equity

   $ 268,205     $ 137,845  
    


 


 

See accompanying notes

 

Page 2


DENDREON CORPORATION

 

CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)

(Unaudited)

 

    

Three Months Ended

March 31,


 
     2004

    2003

 

Revenue

   $ 4,679     $ 1,776  

Operating expenses:

                

Research and development

     12,545       7,762  

General and administrative

     5,297       1,718  

Marketing

     248       117  
    


 


Total operating expenses

     18,090       9,597  
    


 


Loss from operations

     (13,411 )     (7,821 )

Interest income

     851       215  

Interest expense

     (84 )     (101 )

Other expense

     (290 )     —    
    


 


Loss before income taxes

     (12,934 )     (7,707 )

Foreign income tax expense

     31       —    
    


 


Net loss

   $ (12,965 )   $ (7,707 )
    


 


Basic and diluted net loss per share

   $ (0.24 )   $ (0.29 )
    


 


Shares used in computation of basic and diluted net loss per share

     53,541       26,729  
    


 


 

See accompanying notes

 

Page 3


DENDREON CORPORATION

 

CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

 

     Three Months Ended
March 31,


 
     2004

    2003

 

OPERATING ACTIVITIES

                

Net loss

   $ (12,965 )   $ (7,707 )

Adjustments to reconcile net loss to net cash used in operating activities:

                

Depreciation expense

     663       480  

Non-cash stock-based compensation expense

     78       75  

Non-cash stock-based consulting expense

     —         39  

Non-cash interest expense

     4       3  

Impairment of fixed assets

     744       —    

Changes in current assets and liabilities:

                

Accounts receivable

     (319 )     1,137  

Other current assets

     (772 )     689  

Deposits and other assets

     6       2  

Deferred revenue

     (26 )     (1,159 )

Accounts payable

     (869 )     (639 )

Accrued liabilities and compensation

     (1,435 )     (618 )
    


 


Net cash used in operating activities

     (14,891 )     (7,698 )
    


 


INVESTING ACTIVITIES

                

Purchases of investments

     (126,249 )     (6,606 )

Maturities of investments

     36,773       16,142  

Proceeds from asset disposals

     —         500  

Purchases of property and equipment

     (400 )     (330 )

Deferred acquisition costs

     —         (306 )
    


 


Net cash (used in) provided by investing activities

     (89,876 )     9,400  
    


 


FINANCING ACTIVITIES

                

Proceeds from capital lease financing agreement

     748       252  

Payments on capital lease obligations

     (342 )     (266 )

Proceeds from sale of equity securities

     140,488       —    

Proceeds from exercise of stock options

     4,017       85  

Issuance of common stock under the Employee Stock Purchase Plan

     625       285  
    


 


Net cash provided by financing activities

     145,536       356  
    


 


NET INCREASE IN CASH AND CASH EQUIVALENTS

     40,769       2,058  

CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR

     44,349       11,263  
    


 


CASH AND CASH EQUIVALENTS AT END OF PERIOD

   $ 85,118     $ 13,321  
    


 


 

See accompanying notes

 

Page 4


DENDREON CORPORATION

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

 

1. BUSINESS, PRINCIPLES OF CONSOLIDATION AND BASIS OF PRESENTATION

 

Description of Business

 

We were founded in 1992 as a Delaware corporation and we are headquartered in Seattle, Washington. We are a biotechnology company focused on the discovery, development and commercialization of targeted therapies for cancer. Our portfolio includes product candidates to treat a wide range of cancers using therapeutic vaccines, monoclonal antibodies, and small molecules. Our most advanced product candidate is Provenge, a therapeutic vaccine for the treatment of prostate cancer.

 

Principles of Consolidation

 

The consolidated financial statements include the accounts of Dendreon and its wholly owned subsidiary. All material inter-company transactions and balances have been eliminated in consolidation. On July 30, 2003, we completed the acquisition of Corvas International, Inc., “Corvas” (See Note 3 – Significant Events). In accordance with Statement of Financial Accounting Standards (“SFAS”), No. 141, “Business Combinations,” we have included the results of operations of Corvas in our consolidated results since the acquisition on July 30, 2003.

 

Basis of Presentation

 

The accompanying unaudited financial statements reflect, in the opinion of management, all adjustments (consisting of normal recurring adjustments) necessary for a fair presentation of our financial position, results of operations and cash flows for each period presented in accordance with accounting principles generally accepted in the United States for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States have been condensed or omitted from the accompanying statements. These interim financial statements should be read in conjunction with the audited financial statements and related notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2003. The accompanying financial information as of December 31, 2003 has been derived from audited financial statements. Operating results for the three-month period ended March 31, 2004 is not necessarily indicative of future results that may be expected for the year ending December 31, 2004. Certain prior year items have been reclassified to conform to the current year presentation, including certain operating expenses aggregating approximately $853,000 previously reported as general and administrative expenses that have been reclassified to research and development and marketing expenses for the three months ended March 31, 2003. Items reclassified include certain costs related to human resources, facilities, information technology, and finance and accounting.

 

2. RECENT ACCOUNTING PRONOUNCEMENTS

 

In January 2003, the FASB issued FIN No. 46,” Consolidation of Variable Interest Entities.” This interpretation of Accounting Research Bulleting No. 51, “Consolidated Financial Statements” addresses consolidation of business enterprises of variable interest entities in which: (1) the equity investment at risk is not sufficient to permit the entity to finance its activities without additional subordinated financial support from other parties, which is provided through other interest that will absorb some or all of the expected losses of the entity and (2) the equity investors lack one or more of certain essential characteristics of a controlling interest. FIN No. 46 became effective on January 1, 2004. Adoption of this standard had no material impact on the company’s financial position, results of operations or cash flows.

 

3. SIGNIFICANT EVENTS

 

Underwritten Public Offering

 

In January 2004, we sold 11.8 million shares of our common stock at a price of $12.75 per share in an underwritten public offering. We received gross proceeds of $150 million, or $140.5 million net of underwriting discounts, commissions and other offering costs.

 

Acquisition of Corvas International, Inc.

 

On February 24, 2003, we agreed to acquire Corvas pursuant to a merger agreement among Corvas, our wholly-owned subsidiaries, Seahawk Acquisition, Inc. and Dendreon San Diego LLC (formerly known as Charger Project LLC), and us. On July 30, 2003, in

 

Page 5


accordance with the terms of the merger agreement, we completed the acquisition of Corvas by merging Seahawk Acquisition, Inc. with and into Corvas, and then merging Corvas with and into Dendreon San Diego LLC. As a result of these transactions, Corvas became a wholly-owned subsidiary of Dendreon operating as a limited liability company.

 

On July 30, 2003, the effective date of the acquisition, each outstanding share of Corvas common stock was converted into the right to receive 0.45 of a share of our common stock, with cash to be paid in lieu of fractional shares. In connection with the acquisition, we issued a total of 12.4 million shares of our common stock to former Corvas stockholders. In addition, at the effective time of the acquisition, we assumed all stock options outstanding under Corvas’ existing stock option plans. These options, as adjusted to reflect the exchange ratio as provided in the merger agreement, were for approximately 1.5 million shares of our common stock subject to the original vesting terms. We recorded deferred stock-based compensation of $511,000 related to the intrinsic value of unvested stock options assumed in the merger.

 

In connection with the Corvas acquisition, we initiated an integration plan in August 2003 to consolidate and restructure certain functions of Corvas primarily consisting of the termination of certain Corvas personnel. These costs have been recognized as liabilities assumed in the purchase business combination in accordance with EITF Issue No. 95-3 “Recognition of Liabilities in Connection with Purchase Business Combinations”. The severance costs were approximately $2.2 million, of which $1.8 million has been paid through March 31, 2004 and $92,000 has been reversed as of March 31, 2004, resulting in a remaining accrual of approximately $250,000.

 

The total value of the acquisition is approximately $69.6 million, including shares issued valued at $62.9 million, the stock options assumed valued at $4.4 million, and transaction costs of $2.3 million. The value of our shares used in determining the purchase price was $5.06 per share, based on the average of closing prices of our common stock for a range of seven trading days, consisting of the day of the announcement of the merger, February 25, 2003, and the three days prior and three days subsequent to that announcement. The acquisition is being accounted for under the purchase method of accounting. The following table summarizes the allocation of the purchase price to the assets acquired, liabilities assumed and other charges at the date of acquisition.

 

(in thousands)


   July 30, 2003

Cash and cash equivalents

   $ 3,334

Short - and long-term investments

     76,283

Other current assets

     1,906

Property, plant and equipment

     2,143
    

Total assets acquired

     83,666
    

Current liabilities

     2,813

Accrued severance

     2,181

Long term debts

     12,352
    

Total liabilities

     17,346
    

Net assets acquired

     66,320

Deferred stock compensation

     511

In-process research and development

     2,762
    

Total purchase price

   $ 69,593
    

 

Acquired In-process Research and Development. Approximately $1.8 million of the purchase price was initially allocated to IPR&D related to the Corvas’ rNapc2 cardiovascular product candidate that, as of the acquisition date, had not reached technological feasibility and had no alternative future use. In the fourth quarter of 2003, we recorded additional IPR&D of $982,000 due to a change in the estimated fair value of certain acquired assets. Accordingly, $2.8 million was immediately expensed in the consolidated statement of operations for the twelve months ended December 31, 2003.

 

Any future adjustments to the fair values of the net assets and liabilities acquired will affect the allocation of the purchase price and may affect the IPR&D charge.

 

The estimated fair value of the rNAPC2 product candidate was determined based on the use of discounted cash flow analyses. Estimated after-tax cash flows were probability weighted to take into account the stage of completion and risks surrounding the successful development and commercialization of rNapc2. These cash flows were then discounted to present value using a discount rate of 20%.

 

Page 6


The following unaudited pro forma information for the three months ended March 31, 2003 combines operating results of the Company and Corvas as if they had been combined at the beginning of the period. Pro forma data is not necessarily indicative of future results.

 

    

Three months ended

March 31,


 

(in thousands, except per share amounts)


   2004

    2003

 
     (actual)     (pro forma)  

Revenues

   $ 4,679     $ 1,814  

Net loss

   $ (12,965 )   $ (12,418 )

Basic and diluted net loss per share

   $ (0.24 )   $ (0.32 )

Shares used in computation of basic and diluted net loss per share

     53,541       39,166  

 

The pro forma financial results also include pro forma adjustments for an increase in deferred stock-based compensation expense related to Corvas’ unvested stock options assumed by Dendreon as of July 30, 2003. The pro forma financial results do not include the pro forma effect of the IPR&D charge as this is a non-recurring charge resulting from the acquisition. The pro forma information is not necessarily indicative of results that would have occurred had the acquisition been in effect for the periods represented or indicative of results that may be achieved in the future.