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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

         
  þ   QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
       
    FOR QUARTERLY PERIOD ENDED MARCH 31, 2005
 
       
      OR
 
       
  o   TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Commission File Number: 0-20117

ENCYSIVE PHARMACEUTICALS INC.


(Exact name of registrant as specified in its charter)
     
Delaware   13-3532643

(State or other jurisdiction of   (I.R.S. Employer Identification No.)
incorporation or organization)    
         
4848 Loop Central Drive, Suite 700, Houston, Texas
    77081  

(Address of principal executive office)
  (Zip code)

(713) 796-8822


(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 þ No o

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).

Yes þ No o

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

     
Class   Outstanding at April 25, 2005
Common stock, $0.005 par value
  58,081,067
 
 

 


ENCYSIVE PHARMACEUTICALS INC.

TABLE OF CONTENTS

                 
            PAGE NO.
Part I.   Financial Information        
 
               
  Item 1:   Financial Statements (Unaudited)        
 
               
    Consolidated Balance Sheets as of March 31, 2005 and December 31, 2004     1  
 
               
    Consolidated Statements of Operations and Comprehensive Loss for the three nine months ended March 31, 2005 and 2004     2  
 
               
    Consolidated Statements of Cash Flows for the three months ended March 31, 2005 and 2004     3  
 
               
    Notes to Consolidated Financial Statements     4  
 
               
  Item 2:   Management’s Discussion And Analysis Of Financial Condition And Results Of Operations     11  
 
               
  Item 3:   Quantitative And Qualitative Disclosures About Market Risk     21  
 
               
  Item 4:   Controls And Procedures     21  
 
               
Part II.   Other Information        
 
               
  Item 1:   Legal Proceedings     21  
 
               
  Item 2:   Unregistered Sales of Equity Securities and Use of Proceeds     21  
 
               
  Item 3:   Defaults Upon Senior Securities     21  
 
               
  Item 4:   Submission Of Matters To A Vote Of Security Holders     22  
 
               
  Item 5:   Other Information     22  
 
               
  Item 6:   Exhibits     22  
 
               
SIGNATURES         23  
 Certification of CEO Pursuant to Rule 13a-14(a)
 Certification of CFO Pursuant to Rule 13a-14(a)
 Certification of CEO Pursuant to Section 1350
 Certification of CFO Pursuant to Section 1350

 


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ENCYSIVE PHARMACEUTICALS INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS
($ in thousands, except per share data)
(Unaudited)
                 
    March 31,     December 31,  
    2005     2004  
ASSETS
               
 
               
Current assets:
               
Cash and cash equivalents
  $ 123,690     $ 46,130  
Short-term investments
    58,441       22,971  
Accounts receivable
    2,313       4,816  
Other current receivables
    163       348  
Prepaids
    1,926       849  
 
           
Total current assets
    186,533       75,114  
 
               
Equipment and leasehold improvements, net
    5,856       5,107  
Deferred debt origination costs, net of accumulated amortization of $37
    4,604        
Intangible and other assets, net of accumulated amortization of $500 and $474
    525       551  
 
           
Total assets
  $ 197,518     $ 80,772  
 
           
 
               
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
 
               
Current liabilities:
               
Accounts payable
  $ 3,167     $ 2,897  
Accrued expenses
    13,862       12,300  
Deferred revenue
    1,288       561  
 
           
Total current liabilities
    18,317       15,758  
 
               
Deferred revenue
    2,252       1,119  
Long-term debt
    131,658       1,730  
Minority interest in Revotar
    363       628  
 
               
Commitments and contingencies
               
 
               
Stockholders’ equity:
               
Preferred stock, par value $.005 per share. 5,000,000 shares authorized, none issued or outstanding
           
Common stock, par value $.005 per share. At March 31, 2005 75,000,000 shares authorized; 58,237,582 shares issued, 58,024,582 shares outstanding. At December 31, 2004, 75,000,000 shares authorized; 58,131,254 shares issued, 57,918,254 shares outstanding
    291       291  
Additional paid-in capital
    301,659       300,906  
Deferred compensation expense
    (81 )     (129 )
Treasury stock, 213,000 shares
    (1,602 )     (1,602 )
Accumulated other comprehensive income
    222       189  
Accumulated deficit
    (255,561 )     (238,118 )
 
           
Total stockholders’ equity
    44,928       61,537  
 
           
Total liabilities and stockholders’ equity
  $ 197,518     $ 80,772  
 
           

See accompanying notes to consolidated financial statements

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ENCYSIVE PHARMACEUTICALS INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
($ in thousands, except per share data)
(Unaudited)
                 
    Three Months Ended March 31,  
    2005     2004  
Revenues:
               
Research agreements
  $     $ 761  
Royalty income, net
    2,346       1,792  
License fees, milestones and grants
    194       282  
 
           
Total revenues
    2,540       2,835  
 
           
 
               
Expenses:
               
Research and development
    16,784       12,015  
General and administrative
    3,812       2,485  
 
           
Total expenses
    20,596       14,500  
 
           
 
               
Operating loss
    (18,056 )     (11,665 )
 
               
Investment income, net
    519       390  
Interest expense
    (171 )     (40 )
 
           
Loss before minority interest
    (17,708 )     (11,315 )
 
               
Minority interest in loss of Revotar
    265       194  
 
           
 
               
Net loss
    (17,443 )     (11,121 )
 
               
Other comprehensive income:
               
Unrealized gain on foreign currency translation
    33       79  
 
           
 
               
Comprehensive loss
  $ (17,410 )   $ (11,042 )
 
           
 
               
Net loss per common share-basic and diluted
  $ (0.30 )   $ (0.21 )
 
           
 
               
Weighted average common shares used to compute basic and diluted net loss per share
    57,655,886       52,178,130  
 
           

See accompanying notes to consolidated financial statements

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ENCYSIVE PHARMACEUTICALS INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

($ in thousands)

(Unaudited)
                 
    Three Months Ended March 31,  
    2005     2004  
Cash flows from operating activities:
               
Net loss
  $ (17,443 )   $ (11,121 )
Adjustments to reconcile net loss to net cash used in operating activities:
               
Depreciation and amortization
    327       243  
Minority interest in loss of Revotar
    (265 )     (194 )
Expenses paid with stock
    480       201  
Stock-based compensation expense
    61       67  
Loss on disposition of fixed assets
    7       3  
Amortization of debt issue costs
    37        
Amortization of discount/premium on investments
    (7 )      
Change in interest receivable included in short-term investments
    (14 )     119  
Change in operating assets and liabilities:
               
Accounts receivable
    2,503       (11 )
Prepaids
    (1,078 )     (761 )
Other current receivables
    179       498  
Accounts payable and accrued expenses
    1,861       1,147  
Deferred revenue
    1,860       (140 )
 
           
Net cash used in operating activities
    (11,492 )     (9,949 )
 
           
 
               
Cash flows from investing activities:
               
Purchases of equipment and leasehold improvements
    (1,100 )     (275 )
Purchases of investments
    (63,362 )     (13,000 )
Maturity of investments
    27,913       4,000  
 
           
Net cash used in investing activities
    (36,549 )     (9,275 )
 
           
 
               
Cash flows from financing activities:
               
Proceeds from sale of common stock and option and warrant exercises, net
    261       2,526  
Debt issue costs
    (4,641 )      
Borrowing (repayment) of long-term debt
    130,000       (6,000 )
 
           
Net cash provided by (used in) financing activities
    125,620       (3,474 )
 
               
Effect of exchange rate changes on cash
    (19 )     (23 )
 
           
Net (decrease) increase in cash and cash equivalents
    77,560       (22,721 )
 
               
Cash and cash equivalents at beginning of period
    46,130       65,302  
 
           
Cash and cash equivalents at end of period
  $ 123,690     $ 42,581  
 
           
 
               
Supplemental schedule of noncash financing activities:
               
Stock-based compensation expense
  $ 61     $ 67  
Issuance of Common Stock for expenses
    480       201  
Interest paid
    3       39  

See accompanying notes to consolidated financial statements

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ENCYSIVE PHARMACEUTICALS INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2005 (unaudited)

(1) Basis of Presentation

     The accompanying unaudited consolidated financial statements of Encysive Pharmaceuticals Inc., a Delaware corporation, and its subsidiaries (collectively referred to as the “Company” or “Encysive”) have been prepared in accordance with accounting principles generally accepted in the United States of America (“USA”) for interim financial information and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. They do not include all information and notes required by accounting principles generally accepted in the USA for complete financial statements. It is recommended that these interim condensed consolidated financial statements be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2004. Except as disclosed herein, there has been no material change in the information disclosed in the notes to the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2004. In the opinion of management, all adjustments (consisting only of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three-month period ended March 31, 2005, are not necessarily indicative of the results that may be expected for any other interim period or for the year ending December 31, 2005.

(2) Organization and Significant Accounting Policies

     (a) Organization

     Encysive is a biopharmaceutical company focused on the discovery, development and commercialization of novel synthetic small molecule compounds to address unmet medical needs. The Company’s research and development programs are predominantly focused on the treatment and prevention of interrelated diseases of the vascular endothelium and exploit its expertise in the area of the intravascular inflammatory process, referred to as the inflammatory cascade, and vascular diseases. Since its formation in 1989, the Company has been engaged principally in research and drug discovery programs and clinical development of certain drug compounds.

     The Company is presently working on a number of long-term development projects that involve experimental and unproven technology, which may require many years and substantial expenditures to complete, and which may or may not be successful. Sales of the Company’s first FDA-approved product, Argatroban, for which it receives royalty income, began during November 2000.

     (b) Basis of Consolidation

     The Company’s consolidated financial statements include the accounts of the Company, its wholly owned subsidiaries, ImmunoPharmaceutics, Inc. (“IPI”), a California corporation, Encysive, L.P. (“ELP”), a Delaware limited partnership, EP-ET, LLP, a Delaware limited partnership, Encysive (UK) Limited, a private company located in the United Kingdom (UK), and its majority controlled subsidiary, Revotar Biopharmaceuticals AG (“Revotar”), a German corporation. All material intercompany balances and transactions have been eliminated.

     (c) Stock-Based Compensation

     At March 31, 2005, the Company had five stock-based compensation plans for employees and non-employee directors. The Company accounts for those plans under the recognition and measurement principles of Accounting Principles Board Opinion No. 25, “Accounting for Stock Issued to Employees,” and related interpretations. The Company’s results of operations for the three-month periods ended March 31, 2005 and 2004, included stock-based compensation expense arising from the grant of shares of restricted common stock to employees and the recognition of deferred

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compensation expense arising from the grant of stock options in March 2003 to certain employees, which were subject to the approval of stockholders of an amendment to increase the authorized shares in the 1999 plan. No other stock-based employee compensation expense is reflected in net loss, however, as all options granted under those plans had an exercise price equal to the market price of the underlying Common Stock on the date of grant. The following table illustrates the effect on net loss and loss per share if the Company had applied the fair value recognition provisions of FASB Statement of Financial Accounting Standards No. 123, “Accounting for Stock-Based Compensation,” to stock-based employee compensation (dollars in thousands, except for per share data).

     In December 2004, the FASB issued Statement No. 123R, “Share-Based Payment” (“FAS 123R”), which requires the measurement of all employee share-based payments to employees, including grants of employee stock options, using a fair-value based method and the recording of such expense in our consolidated statements of operations and comprehensive loss. The implementation of accounting provisions of FAS 123R has been delayed and will now be effective for annual reporting periods beginning after June 15, 2005. The Company is required to adopt FAS 123R in the first quarter of 2006. The pro forma disclosures previously permitted under FAS 123 no longer will be an alternative to financial statement recognition. Although we have not yet determined whether the adoption of FAS 123R will result in amounts that are similar to the current pro forma disclosures under FAS 123, we are evaluating the requirements of FAS 123R and expect the adoption may have a significant adverse impact on our future consolidated statements of operations and comprehensive loss.

                 
    Three Months Ended  
    March 31,  
    2005     2004  
Net loss, as reported
  $ (17,443 )   $ (11,121 )
 
               
Add: Stock-based employee compensation expense included in reported net loss
    13       28  
 
               
Deduct: Total stock-based employee compensation expense determined under fair value method for all awards
    (1,018 )     (604 )
 
           
Pro forma net loss
  $ (18,448 )   $ (11,697 )
 
           
 
               
Loss per share:
               
As reported, basic and diluted
  $ (0.30 )   $ (0.21 )
Pro forma, basic and diluted
  $ (0.32 )   $ (0.22 )

     The per-share weighted average fair value of stock options granted during the three-month periods ended March 31, 2005 and 2004, was $6.62 and $5.99, respectively, on the grant date using the Black-Scholes option pricing model with the following assumptions:

                 
    Three Months Ended  
    March 31,  
    2005     2004  
Expected dividend yield
    0.0 %     0.0 %
Risk-free interest rate
    4.2 %     2.6 %
Expected volatility
    69.3 %     74.5 %
Expected life in years
    4.92       4.79  

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     (d) Debt Issue Costs

     The Company incurred costs, principally comprised of underwriting fees and various legal and professional fees, of approximately $4,641,000 related to the issue of its 2.50% Convertible Senior Notes due 2012 (the “Notes”) in March 2005. Recognition of the debt issue costs is deferred, and recognized from the issuance of the Notes through the maturity date of the Notes, March 15, 2012. Interest expense in the three-months ended March 31, 2005, includes approximately $37,000 in amortized debt issue costs. Remaining unamortized debt issue costs were approximately $4,604,000 at March 31, 2005. For additional information about the Notes, see Note 9.

(3) Capital Stock

     In March 2005, the Company issued the Notes in the principal amount of $130,000,000. As the Notes are convertible into the Company’s common stock, the Company has reserved 9,322,001 shares for issuance upon conversion, including 213,000 treasury shares. For additional information about the Notes, see Note 9. The Company has reserved Common Stock for issuance as of March 31, 2005, as follows:

         
Stock option plans
    7,444,750  
2.50% Convertible Senior Notes due 2012
    9,322,001  
 
     
Total shares reserved
    16,766,751  

     The Company has proposed to its stockholders for consideration at its 2005 annual meeting scheduled for May 11, 2005, that the number of authorized shares be increased from 75,000,000 to 150,000,000.

(4) Cash, Cash Equivalents, and Short-Term Investments

     Cash equivalents are considered to be those securities or instruments with original maturities, when purchased, of three months or less and are recorded at cost. Short-term investments consist of debt securities with remaining maturities of less than one year and original maturities greater than three months at the purchase date. The Company classifies all short-term investments as held-to-maturity. Held-to-maturity securities are those securities in which the Company has the ability and intent to hold the security until maturity. Short-term investments are stated at amortized cost plus accrued interest. Interest income is accrued as earned. The Company evaluates the carrying value of its securities by comparing the carrying values of the securities to their market values. In the event that the fair value of a security were to decline below its carrying cost, and in the opinion of management such decline was other than temporary, the Company would record a loss and reduce the carrying value of such security to its fair value. Composition of cash and investments was as follows (dollars in thousands):

                 
    March 31, 2005     December 31, 2004  
Cash and cash equivalents:
               
Demand and money market accounts
  $ 334     $ 881  
Corporate commercial paper
    123,356       45,249  
 
           
Total cash and cash equivalents
  $ 123,690     $ 46,130  
 
           

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Investments at March 31, 2005, and December 31, 2004, were as follows (dollars in thousands):

                                 
    As of March 31, 2005  
            Gross     Gross        
Short-term investments   Amortized     Unrealized     Unrealized     Estimated  
Held-to-maturity   Cost     Gains     Losses     Fair Value  
Corporate commercial paper and loan participations
  $ 56,425     $ 5     $ (29 )   $ 56,401  
 
                               
US Government agency securities
    2,016             (33 )     1,983  
 
                       
 
                               
Total short-term held-to-maturity investments
  $ 58,441     $ 5     $ (62 )   $ 58,384  
 
                       
                                 
    As of December 31, 2004  
            Gross     Gross        
Short-term investments   Amortized     Unrealized     Unrealized     Estimated  
Held-to-maturity   Cost     Gains     Losses     Fair Value  
U.S. Government agency securities
  $ 2,006     $     $ (21 )   $ 1,985  
 
                               
Corporate commercial paper
    19,964       14       (46 )     19,932  
 
                               
Corporate debt securities
    1,001             (1 )     1,000  
 
                       
 
                               
Total short-term held-to-maturity investments
  $ 22,971     $ 14     $ (68 )   $ 22,917  
 
                       

(5) Net Loss per Common Share

     Basic net loss per common share is calculated by dividing the net loss by the weighted average number of common and common equivalent shares outstanding during the period. For the three-month periods ended March 31, 2005 and 2004, the weighted average common shares used to compute basic and diluted net loss per common share totaled 57,655,886 and 52,178,130, respectively. Securities convertible into Common Stock comprised of stock options, warrants, shares of common stock reserved for issuance upon conversion of the Notes and unvested shares of restricted common stock totaling 15,033,552 and 5,423,117 shares at March 31, 2005 and 2004, respectively, were not used in the calculation of diluted net loss per common share because the effect would have been antidilutive.

(6) Income Taxes

     The Company did not incur tax expense (benefit) during the three-month periods ended March 31, 2005 and 2004, due to operating losses and the related increase in the valuation allowance.

(7) Entity-Wide Geographic Data

     The Company operates in a single business segment that includes research and development of pharmaceutical products. The following table summarizes the Company’s long-lived assets in different geographic locations (dollars in thousands):

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    March 31, 2005     December 31, 2004  
Long-lived assets:
               
United States
  $ 10,053     $ 4,591  
Germany
    932       1,067  
 
           
Total
  $ 10,985     $ 5,658  
 
           

     The following table summarizes the Company’s revenues in different geographic locations (dollars in thousands):

                 
    Three Months Ended  
    March 31, 2005     March 31, 2004  
Revenues:
               
United States
  $ 2,486     $ 2,693  
Germany
    54       142  
 
           
Total
  $ 2,540     $ 2,835  
 
           

     The Company’s revenues are primarily derived from several entities, each of whom represents a significant percentage of total revenues. The following table summarizes the Company’s sources of revenues from its principal customers (dollars in thousands):

                 
    Three Months Ended  
    March 31, 2005     March 31, 2004  
Customers:
               
GSK
  $ 2,346     $ 1,792  
Schering-Plough
    140       901  
Other
    54       142  
 
           
Total
  $ 2,540     $ 2,835  
 
           

(8) Foreign Subsidiary

     In April 2005, the stockholders of Revotar agreed to restructure Revotar’s capitalization (the “Restructuring”). Under the terms of the Restructuring, Revotar’s stockholders other than the Company have agreed to contribute additional funds to Revotar, and the Company’s ownership will be reduced to approximately 14% of the outstanding common stock of Revotar. Revotar’s other stockholders may also subsequently purchase the shares of Revotar common stock owned by the Company for nominal consideration. Upon the funding of Revotar by the other stockholders, the Company has agreed to license its worldwide rights to bimosiamose and certain follow-on compounds to Revotar for which it could receive substantial future royalty payments from Revotar in the event that these compounds are subsequently approved and commercialized, or licensed to a third party. Further, the Company has agreed to cancel its outstanding loan, and accrued interest thereon, of approximately $3.7 million. The transaction will become effective upon contribution of the additional capital by Revotar’s other stockholders. For additional discussion of Revotar’s indebtedness, see Note 9. Following the completion of the Restructuring, the Company’s consolidated financial statements will no longer include the results of Revotar. The Company’s management believes that the Restructuring will not have a material adverse effect on the Company’s results of operations or financial position.

     Encysive formed Revotar in 2000 to conduct research and development of novel small molecule compounds and to develop and commercialize selectin antagonists. The Company initially retained ownership of approximately 55% of the outstanding common stock of Revotar and has consolidated the financial results of Revotar into Encysive’s consolidated financial statements. Since the development and commercialization rights contributed by the Company to Revotar had no basis for financial reporting purposes, the Company assigned no value to its contribution of intellectual property rights. The Company’s equity in the originally contributed assets by the minority stockholders is included with the minority interest in Revotar on the consolidated balance sheets at March 31, 2005, and December 31, 2004.

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