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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, 2005

 

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   91-1463450
(State or other jurisdiction of
incorporation or organization)
  (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, 2005


Common Stock, $0.01 par value   63,846,090

 



Table of Contents

ICOS CORPORATION

FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2005

 

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, 2005
and 2004

   1
    

Condensed Consolidated Balance Sheets as of March 31, 2005 and December 31, 2004

   2
    

Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2005
and 2004

   3
    

Notes to Condensed Consolidated Financial Statements

   4

ITEM 2.

  

Management’s Discussion and Analysis of Results of Operations and Financial Condition

   10

ITEM 3.

  

Quantitative and Qualitative Disclosures about Market Risk

   32

ITEM 4.

  

Controls and Procedures

   32

PART II. Other Information

    

ITEM 1.

  

Legal Proceedings

   33

ITEM 6.

  

Exhibits

   33

SIGNATURE

   34

 


Table of Contents

PART 1. Financial Information

 

ITEM 1. Financial Statements

 

ICOS CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share data)

(unaudited)

 

     Three Months Ended
March 31,


 
     2005

    2004

 

Revenue:

                

Lilly ICOS collaboration

   $ 10,360     $ 14,067  

Contract manufacturing

     2,474       2,456  

Co-promotion services

     950       —    
    


 


Total revenue

     13,784       16,523  
    


 


Operating expenses:

                

Research and development

     22,213       17,254  

Marketing and selling

     10,434       9,797  

Cost of contract manufacturing

     1,851       2,513  

General and administrative

     5,005       4,153  
    


 


Total operating expenses

     39,503       33,717  
    


 


Operating loss

     (25,719 )     (17,194 )

Other income (expense):

                

Equity in losses of Lilly ICOS

     (20,679 )     (69,237 )

Interest expense

     (1,704 )     (1,711 )

Interest and other income

     1,718       1,839  
    


 


Net loss

   $ (46,384 )   $ (86,303 )
    


 


Net loss per common share – basic and diluted

   $ (0.73 )   $ (1.36 )
    


 


Weighted-average common shares outstanding – basic and diluted

     63,799       63,237  
    


 


 

See accompanying notes to condensed consolidated financial statements.

 

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ICOS CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

(unaudited)

 

        March 31,   
2005


    December 31,
2004


 
ASSETS                 

Current assets:

                

Cash and cash equivalents

   $ 17,083     $ 12,778  

Investment securities, at market value

     177,884       209,332  

Interest receivable

     1,445       1,607  

Receivable from Lilly ICOS

     11,540       15,053  

Other

     6,815       7,334  
    


 


Total current assets

     214,767       246,104  

Investment securities, at market value

     43,772       52,052  

Property and equipment, net

     19,168       19,206  

Deferred financing costs and other

     7,312       7,619  
    


 


     $ 285,019     $ 324,981  
    


 


LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)                 

Current liabilities:

                

Payables and accruals

   $ 21,017     $ 21,374  

Accrued interest

     1,393       2,787  

Due to Lilly ICOS

     20,748       14,147  

Deferred revenue

     1,391       1,495  
    


 


Total current liabilities

     44,549       39,803  
    


 


Convertible subordinated debt

     278,650       278,650  
    


 


Stockholders’ equity (deficit):

                

Common stock

     638       636  

Additional paid-in capital

     796,557       794,311  

Accumulated other comprehensive income

     (1,270 )     (698 )

Accumulated deficit

     (834,105 )     (787,721 )
    


 


Total stockholders’ equity (deficit)

     (38,180 )     6,528  
    


 


     $ 285,019     $ 324,981  
    


 


 

See accompanying notes to condensed consolidated financial statements.

 

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ICOS CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(unaudited)

 

     Three Months Ended
March 31,


 
     2005

    2004

 

Cash flows from operating activities:

                

Net loss

   $   (46,384 )   $ (86,303 )

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

                

Depreciation and amortization

     2,420       2,887  

Equity in losses of Lilly ICOS

     20,679       69,237  

Changes in operating assets and liabilities:

                

Receivables and other assets

     4,163       (395 )

Payables and accruals

     (1,855 )     (1,562 )
    


 


Net cash used in operating activities

     (20,977 )     (16,136 )
    


 


Cash flows from investing activities:

                

Purchases of investment securities

     (65,835 )     (169,834 )

Maturities of investment securities

     33,036       26,460  

Sales of investment securities

     71,517       152,568  

Acquisitions of property and equipment

     (1,410 )     (1,212 )

Collection of note receivable arising from sale of partnership interests

     —         6,000  

Investments in Lilly ICOS

     (14,255 )     (24,858 )
    


 


Net cash provided by (used in) investing activities

     23,053       (10,876 )
    


 


Cash flows from financing activities:

                

Proceeds from stock options

     2,229       3,671  
    


 


Net cash provided by financing activities

     2,229       3,671  
    


 


Net increase (decrease) in cash and cash equivalents

     4,305       (23,341 )

Cash and cash equivalents, beginning of period

     12,778       32,729  
    


 


Cash and cash equivalents, end of period

   $ 17,083     $ 9,388  
    


 


Supplemental disclosure of cash flow information:

                

Interest payments on convertible subordinated debt

   $ 2,787     $ 2,957  
    


 


 

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, 2004.

 

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, 2005 and December 31, 2004, and our results of operations and cash flows for the three months ended March 31, 2005 and 2004. Interim results are not necessarily indicative of results for a full year.

 

Revenue Recognition

 

We recognize revenue from our contracts for research, development, marketing and sales services, including those under collaborative agreements, as the related costs are incurred. We refer to this revenue as “collaboration revenue.” Payments received, related to future performance, are deferred and recognized as revenue when the future performance occurs.

 

Nonrefundable upfront technology license fees, for product candidates where we are providing continuing services related to product development, are deferred, and recognized as revenue as we provide the services required under the agreement. We recognize nonrefundable upfront technology fees as revenue based on the ratio of current development costs to total estimated current and future development costs through the date we expect to file a New Drug Application (NDA), or an equivalent, with the U.S. Food and Drug Administration (FDA). We believe this method appropriately matches revenue with the estimated costs of

 

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the development effort. We also believe that development costs are the best available surrogate for benefits obtained as data is collected and other research and development activities progress in the collaboration.

 

We estimate the total projected development costs based on the specific terms of each agreement, our judgment and experience and, when appropriate, the expertise of our collaboration partners. The ability to estimate total development effort and costs can vary significantly for each product candidate due to the inherent complexities and uncertainties of drug development. In the past, we have been able to estimate total expected development costs, for certain product candidates, because they were in later stages of clinical development at the time such estimates were prepared or our partner had substantial previous experience in the relevant field of study. However, we may not be able to reasonably estimate total expected development costs for product candidates in the future, particularly if such product candidates are in earlier stages of clinical development. To the extent we cannot estimate the costs to complete development, but can estimate an expected NDA filing date, we will recognize license fee revenue ratably through the NDA filing date. If we are unable to reasonably estimate either total costs to complete development or an expected NDA filing date (performance period), we will defer revenue recognition until one of those estimates can be made or the project is discontinued.

 

Milestones, in the form of additional license fees, typically represent nonrefundable payments to be received in conjunction with the achievement of a specific event identified in the contract, such as initiation or completion of specified clinical development activities. We believe that a milestone represents the culmination of a distinct earnings process when it is not associated with ongoing research, development or other performance on our part. We recognize such milestones as revenue when they become due and collectibility is reasonably assured. When a milestone does not represent the culmination of a distinct earnings process, we recognize revenue at the time such payments are due, provided collectibility is reasonably assured, based on the ratio of effort to date (in terms of costs or time, as discussed above) to total estimated development effort. Any remaining balance is deferred and recognized as revenue over the estimated remaining product development period, in the same manner as our upfront technology license fees.

 

The timing and amount of revenue that we recognize from licenses of technology, either from upfront fees or milestones where we are providing continuing services related to product development, is dependent upon our estimates of total product development effort as well as the timing of such effort over the estimated development period. As product candidates move through the development process, it is necessary to revise these estimates to consider changes to the product development cycle, such as changes in the clinical development plan, regulatory requirements, or various other factors, many of which may be outside of our control. The impact on revenue of changes in our estimates and the timing thereof, is recognized prospectively, over the remaining estimated product development period.

 

Contract manufacturing revenue, including fees earned for process development and manufacturing services performed for third parties, is recognized when the manufacturing obligation is fulfilled or manufacturing services are performed, as appropriate, based on the terms of the agreement, and collectibility is reasonably assured. Payments received in excess of amounts earned are recorded as deferred revenue.

 

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Co-promotion services revenue represents fees earned for physician details (sales calls) and other activities related to our promotion of others’ products. We recognize co-promotion service revenue, per-detail, at contractual rates, based on the number of qualifying sales calls performed during the period. Contingent fee revenue, based on achievement of certain sales objectives would be recognized, per-detail, once the objectives are achieved or exceeded.

 

Stock Based Compensation

 

We apply the provisions of Accounting Principles Board (APB) 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 applicable 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 following pro forma amounts:

 

     Three Months Ended
March 31,


 
     2005

    2004

 

Net loss:

                

As reported

   $ (46,384 )   $ (86,303 )

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

     (7,690 )     (9,041 )
    


 


Pro forma

   $ (54,074 )   $ (95,275 )
    


 


Net loss per share—basic and diluted:

                

As reported

   $ (0.73 )   $ (1.36 )
    


 


Pro forma

   $ (0.85 )   $ (1.51 )
    


 


 

The estimated per share weighted-average grant date fair value of stock options awarded during the three months ended March 31, 2005 and 2004, was $12.16 and $27.67, respectively. Amounts were determined using the Black-Scholes option pricing model based on the following assumptions:

 

     Three Months Ended
March 31,


 
     2005

    2004

 

Expected dividend yield

   0.0 %   0.0 %

Risk-free interest rate

   4.0 %   3.4 %

Expected volatility

   43.0 %   68.1 %

Expected life in years

   6.3     6.6  

 

In the first quarter of 2005, we updated the volatility assumption used to estimate the fair value of our employee stock options. The expected volatility used in 2005 was determined considering historical volatility of our common stock over the preceding two years, implied volatility of near-the-money traded stock options with

 

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remaining contractual maturities of approximately two years and significant changes in our business that we believe have resulted in lower historical and implied volatility.

 

Reclassifications

 

Certain amounts reported in prior years have been reclassified to conform to the 2005 presentation.

 

2. Recent Accounting Pronouncement

 

In December 2004, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards No. 123 (revised 2004), (SFAS 123R), “Share-Based Payment.” On April 14, 2005, the U.S. Securities and Exchange Commission adopted a rule amending the timing of our required implementation of SFAS 123R, from the beginning of the third quarter of 2005, to the beginning of the 2006 first quarter. SFAS 123R requires ICOS to measure the cost of employee services received in exchange for an award of an equity instrument, such as stock options, based on the grant-date fair-value of the award. The associated cost must be recognized over the period during which an employee is required to provide service in exchange for the award (usually the vesting period). SFAS 123R provides for a variety of implementation alternatives, including accounting for the change prospectively or restating previously reported amounts to reflect the compensation expense that would have been recorded had SFAS 123R been applied in those prior periods. We are in the process of determining the impact of SFAS 123R on our financial statements, including which implementation alternative we will select.

 

3. Lilly ICOS Operating Results

 

Lilly ICOS LLC (Lilly ICOS), our 50/50 owned joint venture with Eli Lilly and Company (Lilly), is marketing Cialis® (tadalafil), for the treatment of erectile dysfunction, in North America and Europe. Cialis is also available outside of North America and Europe, where Lilly has exclusive marketing 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, 2005 and 2004.

 

     Three Months Ended
March 31,


 
     2005

    2004

 

Revenue:

                

Product sales, net

   $ 111,194     $ 75,017  

Royalties

     7,790       6,652  
    
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