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SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

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

For The Quarterly Period Ended March 31, 2003

OR

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

Commission File Number: 0-19171

ICOS CORPORATION


(Exact name of registrant as specified in its charter)
   
Delaware

(State or other jurisdiction of
incorporation or organization)
91-1463450

(I.R.S. Employer Identification No.)
   
22021 - 20th Avenue S.E., Bothell, WA 98021


(Address of principal executive offices) (Zip code)

(425) 485-1900


(Registrant’s telephone number, including area code)

Not Applicable


(Former name, former address and former fiscal year, if changed since last report)

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

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).
Yes [X]   No [   ]

Indicate the number of shares outstanding of each of the issuer’s classes of Common Stock, as of the latest practicable date.

         
Class   Outstanding at March 31, 2003

 
Common Stock, $0.01 par value
    62,278,333  


TABLE OF CONTENTS

PART 1. Financial Information
ITEM 1. Financial Statements
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
CONDENSED CONSOLIDATED BALANCE SHEETS
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
ITEM 2. Management’s Discussion and Analysis of Results of Operations and Financial Condition
ITEM 3. Quantitative and Qualitative Disclosure about Market Risk
ITEM 4. Controls and Procedures
PART II. Other Information
ITEM 6. Exhibits and Reports on Form 8-K
SIGNATURE
CERTIFICATIONS
EXHIBIT 99.1
EXHIBIT 99.2


Table of Contents

ICOS CORPORATION
FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2003

TABLE OF CONTENTS

             
        PAGE NO.
       
PART I. Financial Information
       
 
ITEM 1.   Financial Statements
       
   
Condensed Consolidated Statements of Operations for the three months ended March 31, 2003 and 2002
    1  
   
Condensed Consolidated Balance Sheets as of March 31, 2003 and December 31, 2002
    2  
   
Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2003 and 2002
    3  
   
Notes to Condensed Consolidated Financial Statements
    4  
 
ITEM 2.
       
   
Management’s Discussion and Analysis of Results of Operations and Financial Condition
    8  
 
ITEM 3.
       
   
Quantitative and Qualitative Disclosure about Market Risk
    15  
 
ITEM 4.
       
   
Controls and Procedures
    15  
PART II. Other Information
       
 
ITEM 6.
       
   
Exhibits and Reports on Form 8-K
    15  
SIGNATURE
    16  
CERTIFICATIONS
    17  

 


Table of Contents

PART 1. Financial Information

ITEM 1. Financial Statements

ICOS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)

                     
        (in thousands, except per share data)
       
        Three Months Ended March 31,
       
        2003   2002
       
 
Revenue:
               
 
Collaboration revenue from related parties
  $ 5,348     $ 19,356  
 
Licenses of technology
    633       1,380  
 
Contract manufacturing
    1,100       1,800  
 
 
   
     
 
   
Total revenue
    7,081       22,536  
 
 
   
     
 
Operating expenses:
               
 
Research and development
    27,288       35,398  
 
Marketing and selling
    921       3,158  
 
General and administrative
    2,141       1,809  
 
 
   
     
 
   
Total operating expenses
    30,350       40,365  
 
 
   
     
 
   
Operating loss
    (23,269 )     (17,829 )
Other income (expense):
               
 
Equity in losses of affiliates
    (21,547 )     (24,724 )
 
Interest and other income
    3,712       3,333  
 
 
   
     
 
Loss before income taxes
    (41,104 )     (39,220 )
 
Income tax recovery
    612        
 
 
   
     
 
Net loss
  $ (40,492 )   $ (39,220 )
 
 
   
     
 
Net loss per common share – basic and diluted
  $ (0.65 )   $ (0.65 )
 
 
   
     
 
Weighted-average common shares outstanding – basic and diluted
    62,174       60,017  
 
 
   
     
 

See accompanying notes to condensed consolidated financial statements.

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Table of Contents

ICOS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)

                       
          (in thousands)
         
          March 31,   December 31,
          2003   2002
         
 
ASSETS                
Current assets:
               
 
Cash and cash equivalents
  $ 92,967     $ 40,450  
 
Investment securities, at market value
    62,681       159,680  
 
Interest receivable
    3,520       5,099  
 
Receivables from affiliates
    7,400       7,959  
 
Other
    6,170       2,652  
 
 
   
     
 
   
Total current assets
    172,738       215,840  
Investment securities, at market value
    148,436       148,796  
Property and equipment, net
    19,455       20,209  
Other
    632       815  
 
 
   
     
 
 
  $ 341,261     $ 385,660  
 
 
   
     
 
LIABILITIES AND STOCKHOLDERS’ EQUITY                
Current liabilities:
               
 
Payables and accruals
  $ 19,828     $ 25,985  
 
Due to affiliates
    24,424       25,012  
 
Deferred revenue
    2,104       2,305  
 
 
   
     
 
   
Total current liabilities
    46,356       53,302  
 
 
   
     
 
Deferred revenue
    17,101       14,726  
 
 
   
     
 
Stockholders’ equity:
               
 
Common stock
    623       621  
 
Additional paid-in capital
    779,177       777,697  
 
Accumulated other comprehensive income
    2,462       3,280  
 
Accumulated deficit
    (504,458 )     (463,966 )
 
 
   
     
 
   
Total stockholders’ equity
    277,804       317,632  
 
 
   
     
 
 
  $ 341,261     $ 385,660  
 
 
   
     
 

See accompanying notes to condensed consolidated financial statements.

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Table of Contents

ICOS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)

                         
            (in thousands)
           
            Three Months Ended March 31,
           
            2003   2002
           
 
Cash flows from operating activities:
               
 
Net loss
  $ (40,492 )   $ (39,220 )
 
Adjustments to reconcile net loss to net cash used in operating activities:
               
     
Depreciation and amortization
    1,478       1,303  
     
Gain on sale of investment securities, net
    (1,290 )     (117 )
     
Amortization of investment premiums (discounts), net
    1,826       1,259  
     
Equity in losses of affiliates
    21,547       24,724  
     
Revenue from licenses of technology in excess of cash received
    (633 )     (1,380 )
     
Stock compensation expense
    199       105  
     
Change in operating assets and liabilities:
               
       
Receivables
    227       (9,558 )
       
Other assets
    (1,385 )     (882 )
       
Payables and accruals
    (5,419 )     436  
 
 
   
     
 
       
  Net cash used in operating activities
    (23,942 )     (23,330 )
 
 
   
     
 
Cash flows from investing activities:
               
 
Purchases of investment securities
    (19,167 )     (83,577 )
 
Maturities of investment securities
    26,365       43,695  
 
Sales of investment securities
    88,991       22,381  
 
Acquisitions of property and equipment
    (725 )     (1,906 )
 
Investments in affiliates
    (22,135 )     (15,642 )
 
 
   
     
 
       
  Net cash provided by (used in) investing activities
    73,329       (35,049 )
 
 
   
     
 
Cash flows from financing activities:
               
 
Proceeds from stock options and warrants
    1,061       4,517  
 
Borrowings under line of credit
    2,069       2,353  
 
 
   
     
 
       
  Net cash provided by financing activities
    3,130       6,870  
 
 
   
     
 
Net increase (decrease) in cash and cash equivalents
    52,517       (51,509 )
   
Cash and cash equivalents, beginning of period
    40,450       260,905  
 
 
   
     
 
Cash and cash equivalents, end of period
  $ 92,967     $ 209,396  
 
 
   
     
 
Supplemental disclosure of cash flow information:
               
   
Debt forgiveness upon achievement of clinical milestone
  $ 3,055     $ 674  
   
Income tax benefit receivable
  $ 612     $  

See accompanying notes to condensed consolidated financial statements.

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ICOS CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(in thousands unless otherwise noted)

(unaudited)

1.     Summary of Significant Accounting Policies

     The accompanying condensed consolidated financial statements present the results of operations, financial position and cash flows of ICOS Corporation and its wholly-owned subsidiaries, herein collectively referred to as “ICOS”. All material intercompany transactions and balances between entities consolidated in these financial statements have been eliminated.

     The accompanying condensed consolidated financial statements have not been audited. We have condensed or omitted certain information and footnote disclosures normally included in financial statements presented in accordance with accounting principles generally accepted in the United States. We believe the disclosures made are adequate to make the information presented not misleading. However, you should read these condensed consolidated financial statements in conjunction with the consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2002.

     The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities as of the date of the financial statements, and the reported amounts of revenue and expenses during the reporting period. Ultimate results could differ from those estimates.

     In our opinion, the accompanying condensed consolidated financial statements include all adjustments, consisting only of normal recurring items, necessary to present fairly our financial position as of March 31, 2003 and December 31, 2002, and our results of operations and cash flows for the three months ended March 31, 2003 and 2002. Interim results are not necessarily indicative of results for a full year.

     Stock Based Compensation

     We apply the provisions of Accounting Principles Board Opinion No. 25, “Accounting for Stock Issued to Employees,” and related interpretations in accounting for our employee stock option grants. Accordingly, we do not recognize compensation expense for options granted to employees with an exercise price equal to or in excess of the fair value of the underlying common shares at the date of grant. We recognize compensation expense for restricted stock grants over the vesting period.

     Had we determined compensation cost based on the fair value of our stock options on the grant date under Statement of Financial Accounting Standards No. 123, “Accounting for Stock Based Compensation,” our net loss and net loss per share would have been the pro forma amounts indicated as follows:

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      Three Months Ended
      March 31,
     
      2003   2002
     
 
Net loss:
               
 
As reported
  $ (40,492 )   $ (39,220 )
 
Add: Stock based employee compensation expense included in reported net loss
    69        
 
Deduct: Stock based employee compensation expense determined under fair value based method for all awards
    (11,564 )     (8,611 )
 
 
   
     
 
 
Pro forma
  $ (51,987 )   $ (47,831 )
 
 
   
     
 
Net loss per share—basic and diluted:
               
 
As reported
  $ (0.65 )   $ (0.65 )
 
 
   
     
 
 
Pro forma
  $ (0.84 )   $ (0.80 )
 
 
   
     
 

     The per share weighted-average grant date fair value of stock options awarded during the three months ended March 31, 2003 and 2002, was $13.79 and $31.60, respectively, using the Black-Scholes option pricing model with the following assumptions:

                 
    Three Months Ended
    March 31,
   
    2003   2002
   
 
Expected dividend yield
    0.0 %     0.0 %
Risk-free interest rate
    3.3 %     4.8 %
Expected volatility
    67.9 %     68.8 %
Expected life in years
    6.4       6.3  

2.     Revenue from Collaborations and Licenses of Technology, and Equity in Losses of Affiliates

     The following tables summarize our revenue from collaborations with related parties and licenses of technology, and equity in losses of affiliates for the three months ended March 31, 2003 and 2002.

                     
        Three Months Ended March 31,
       
        2003   2002
       
 
Collaboration revenue from related parties:
               
   
Lilly ICOS LLC (“Lilly ICOS”)
  $ 2,053     $ 1,361  
   
Suncos Corporation (“Suncos”)
    2,058       13,889  
   
ICOS-Texas Biotechnology L.P. (“ICOS-TBC”)
    1,237       4,106  
   
 
   
     
 
 
  $ 5,348     $ 19,356  
   
 
   
     
 
Licenses of technology:
               
   
Lilly ICOS
  $ 31     $ 623  
   
ICOS Clinical Partners, L.P.
          427  
   
Biogen, Inc. (“Biogen”)
    602       330  
   
 
   
     
 
 
  $ 633     $ 1,380  
   
 
   
     
 
Equity in losses of affiliates:
               
   
Lilly ICOS
  $ (21,547 )   $ (14,230 )
   
Suncos
          (7,984 )
   
ICOS-TBC
          (2,510 )
   
 
   
     
 
 
  $ (21,547 )   $ (24,724 )
   
 
   
     
 

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3.     Affiliate Operating Results

     Lilly ICOS

     Lilly ICOS, our 50/50 owned joint venture with Eli Lilly and Company (“Lilly), began selling its first commercial product, Cialis(tadalafil), for the treatment of erectile dysfunction, in the European Union in January 2003. Cialis is currently available, by prescription, in pharmacies across Europe. Cialis is also available outside of North America and the European Union, in which markets Lilly has exclusive rights and pays royalties to Lilly ICOS equal to 20% of net sales.

     The following table summarizes the operating results of Lilly ICOS for the three months ended March 31, 2003 and 2002.

                     
        Three Months Ended March 31,
       
        2003   2002
       
 
Revenue:
               
 
Product sales, net
  $ 16,615     $  
 
Royalties
    975        
 
 
   
     
 
   
Total revenue
    17,590        
 
 
   
     
 
Cost of sales
    1,604        
Research and development:
               
 
Lilly and other
    16,446       10,839  
 
ICOS
    1,773       1,184  
Selling, general and administrative:
               
 
Lilly and other
    40,582       16,222  
 
ICOS
    280       215  
 
 
   
     
 
   
Total expenses
    60,685       28,460  
 
 
   
     
 
Net loss
  $ (43,095 )   $ (28,460 )
 
 
   
     
 

     Suncos

     For the first quarter of 2002, Suncos incurred $16.0 million of operating losses related to the development of Pafase®. In December 2002, the Pafase development program was discontinued after an interim analysis did not demonstrate clinical benefit in a Phase 3 study for severe sepsis. Upon discontinuation of the Pafase program, Suncos accrued estimated close-out costs, primarily associated with the program’s clinical and manufacturing activities. In the first quarter of 2003, no adjustments to those estimated costs were necessary.

     ICOS-TBC

     For the first quarter of 2002, ICOS-TBC incurred $5.0 million of operating losses related to its endothelin receptor antagonist program. All research and development costs of ICOS-TBC were charged to expense as incurred. In January 2003, we announced that joint development of the endothelin receptor antagonist program, through ICOS-TBC, would not continue. Texas Biotechnology Corporation (“Texas Biotechnology”) agreed to be responsible for all costs and expenses of ICOS-TBC incurred subsequent to December 31, 2002. On April 22, 2003, ICOS entered into an agreement whereby Texas Biotechnology acquired all of our interests in ICOS-TBC for $10.0

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million, with $4.0 million paid on that date and the balance payable, with interest, in two installments over an 18-month period. The installment payments and interest are secured by an irrevocable standby letter of credit from a major U.S. bank. In the second quarter of 2003, our results of operations will include a gain of $10.0 million from this transaction.

4.     Income Tax Recovery

     In the first quarter of 2003, we recognized a federal alternative minimum income tax benefit of $0.6 million as a result of filing a refund claim for such taxes paid for the year ended December 31, 1998.

5.     Comprehensive Loss