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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 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 ACT OF 1934

 

Commission File No. 0-18728

 


 

INDEVUS PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 


 

Delaware   04-3047911

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification Number)

One Ledgemont Center

99 Hayden Avenue

Lexington, Massachusetts

  02421-7966
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (781) 861-8444

 


 

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 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 12(b)-2 of the Exchange Act.)    Yes  x    No  ¨

 

Indicate the number of shares outstanding of each of the issuer’s class of common stock, as of the latest practicable date.

 

Class:


  

Outstanding at May 7, 2004


Common Stock $.001 par value    47,707,496 shares

 



Table of Contents

INDEVUS PHARMACEUTICALS, INC.

INDEX TO FORM 10-Q

 

          PAGE

PART I. FINANCIAL INFORMATION

    

Item 1.

   Financial Statements     
    

Consolidated Balance Sheets as of March 31, 2004 and September 30, 2003

   3
    

Consolidated Statements of Operations for the Three and Six Months ended March 31, 2004 and 2003

   4
    

Consolidated Statements of Cash Flows for the Three and Six Months ended March 31, 2004 and 2003

   5
     Notes to Unaudited Consolidated Financial Statements    6

Item 2.

   Management’s Discussion and Analysis of Financial Condition and Results of Operations    9

Item 3.

   Quantitative and Qualitative Disclosures about Market Risk    14

Item 4.

   Controls and Procedures    15

PART II. OTHER INFORMATION

    

Item 1.

   Legal Proceedings    15

Item 4.

   Submission of Matters to a Vote of Security Holders    16

Item 6.

   Exhibits and Reports on Form 8-K    17

SIGNATURES

   18

 

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Item 1. Financial Statements

 

INDEVUS PHARMACEUTICALS, INC.

CONSOLIDATED BALANCE SHEETS

(Unaudited)

(Amounts in thousands except share data)

 

    

March 31,

2004


   

September 30,

2003


 
ASSETS  

Current assets:

                

Cash and cash equivalents

   $ 47,363     $ 57,717  

Marketable securities

     10,273       26,370  

Accounts receivable

     85       155  

Prepaids and other current assets

     4,419       1,241  
    


 


Total current assets

     62,140       85,483  

Investment in equity securities

     179       134  

Property and equipment, net

     26       33  

Insurance claim receivable

     1,258       1,258  

Prepaid debt issuance costs

     2,833       3,163  
    


 


Total assets

   $ 66,436     $ 90,071  
    


 


LIABILITIES  

Current liabilities:

                

Accounts payable

   $ 965     $ 1,958  

Accrued expenses

     7,901       8,721  

Accrued interest

     950       938  
    


 


Total current liabilities

     9,816       11,617  

Convertible Notes

     72,000       72,000  

License fees payable

     150       200  

Minority interest

     9       13  
STOCKHOLDERS’ DEFICIT  

Preferred stock, $.001 par value, 5,000,000 shares authorized;

                

Series B, 239,425 shares issued and outstanding (liquidation preference at March 31, 2004 $3,034);

     3,000       3,000  

Series C, 5,000 shares issued and outstanding (liquidation preference at March 31, 2004 $503)

     500       500  

Common stock, $.001 par value, 80,000,000 shares authorized; 47,673,114 and 47,175,661 shares issued and outstanding at March 31, 2004 and September 30, 2003, respectively

     48       47  

Additional paid-in capital

     305,025       303,452  

Accumulated deficit

     (324,085 )     (300,691 )

Accumulated other comprehensive loss

     (27 )     (67 )
    


 


Total stockholders’ equity (deficit)

     (15,539 )     6,241  
    


 


Total liabilities and stockholders’ equity (deficit)

   $ 66,436     $ 90,071  
    


 


 

The accompanying notes are an integral part of these unaudited consolidated financial statements.

 

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INDEVUS PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

For the three and six months ended March 31, 2004 and 2003

(Unaudited)

(Amounts in thousands except per share data)

 

    

Three months ended

March 31,


   

Six months ended

March 31,


 
     2004

    2003

    2004

    2003

 

Revenues:

                                

Royalty revenue

   $ 854     $ 2,857     $ 1,639     $ 2,857  

Contract and license fees

     22       14       164       836  
    


 


 


 


Total revenues

     876       2,871       1,803       3,693  

Costs and expenses:

                                

Cost of revenues

     209       596       524       806  

Research and development

     5,142       3,240       12,696       7,017  

Marketing, general and administrative

     5,782       2,160       9,798       4,617  
    


 


 


 


Total costs and expenses

     11,133       5,996       23,018       12,440  
    


 


 


 


Loss from operations

     (10,257 )     (3,125 )     (21,215 )     (8,747 )

Investment income

     180       159       402       350  

Interest expense

     (1,293 )     —         (2,585 )     —    

Minority interest

     —         —         4       —    
    


 


 


 


Net loss

   $ (11,370 )   $ (2,966 )   $ (23,394 )   $ (8,397 )
    


 


 


 


Net loss per common share:

                                

Basic and diluted

   $ (0.24 )   $ (0.06 )   $ (0.49 )   $ (0.18 )
    


 


 


 


Weighted average common shares outstanding:

                                

Basic and diluted

     47,397       46,886       47,304       46,881  
    


 


 


 


 

The accompanying notes are an integral part of these unaudited consolidated financial statements.

 

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INDEVUS PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

For the six months ended March 31, 2004 and 2003

(Unaudited)

(Amounts in thousands)

 

    

Six months ended

March 31,


 
     2004

    2003

 

Cash flows from operating activities:

                

Net loss

   $ (23,394 )   $ (8,397 )

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

                

Depreciation and amortization

     12       8  

Amortization of debt issuance costs

     330       —    

Minority interest in net income of consolidated subsidiary

     (4 )     —    

Change in assets and liabilities:

                

Accounts receivable

     70       481  

Prepaid and other assets

     (3,178 )     (1,527 )

Accounts payable

     (993 )     1,529  

Accrued expenses and other liabilities

     (875 )     229  
    


 


Net cash used in operating activities

     (28,032 )     (7,677 )
    


 


Cash flows from investing activities:

                

Purchases of marketable securities

     (3,210 )     (3,877 )

Proceeds from maturities and sales of marketable securities

     19,302       14,732  

Capital expenditures

     (5 )     (10 )
    


 


Net cash provided by investing activities

     16,087       10,845  
    


 


Cash flows from financing activities:

                

Net proceeds from issuance of common stock

     1,591       66  
    


 


Net cash provided by financing activities

     1,591       66  
    


 


Net change in cash and cash equivalents

     (10,354 )     3,234  

Cash and cash equivalents at beginning of period

     57,717       19,977  
    


 


Cash and cash equivalents at end of period

   $ 47,363     $ 23,211  
    


 


Supplemental information:

                

Interest paid

   $ 2,238     $ —    
    


 


 

The accompanying notes are an integral part of these unaudited consolidated financial statements.

 

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INDEVUS PHARMACEUTICALS, INC.

 

NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

 

A. Basis of Presentation

 

The consolidated interim financial statements included herein have been prepared by Indevus Pharmaceuticals, Inc. (“Indevus” or the “Company”) without audit, pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles in the United States of America have been condensed or omitted pursuant to such rules and regulations. In the opinion of management, the accompanying unaudited consolidated financial statements include all adjustments (consisting only of normal recurring adjustments) necessary to present fairly the consolidated financial position, results of operations and cash flows of the Company. The unaudited consolidated financial statements included herein should be read in conjunction with the audited consolidated financial statements and the notes thereto included in the Company’s Form 10-K for the fiscal year ended September 30, 2003.

 

Indevus is a biopharmaceutical company engaged in the development and commercialization of a diversified portfolio of product candidates, including multiple compounds in late-stage clinical development.

 

B. Basic and Diluted Loss per Common Share

 

During the three month period ended March 31, 2004, securities not included in the computation of diluted earnings per share, because their exercise price exceeded the average market price during the period were as follows: (i) the notes convertible into 10,817,000 shares of Common Stock at a conversion price of $6.656 per share and which are convertible through July 15, 2008 and (ii) options to purchase 524,000 shares of Common Stock at prices ranging from $6.50 to $20.13 with expiration dates ranging up to May 13, 2012. Additionally, during the three month period ended March 31, 2004, potentially dilutive securities not included in the computation of diluted earnings per share, because they would have an antidilutive effect due to the net loss for the period, were as follows: (i) options to purchase 9,468,000 shares of Common Stock at prices ranging from $1.22 to $6.25 with expiration dates ranging up to March 10, 2014; (ii) Series B and C preferred stock convertible into 622,222 shares of Common Stock and (iii) warrants to purchase 55,000 shares of Common Stock with exercise prices ranging from $5.00 to $6.19 and with expiration dates ranging up to July 17, 2006.

 

During the three month period ended March 31, 2003, securities not included in the computation of diluted earnings per share, because their exercise price exceeded the average market price during the period were as follows: (i) options to purchase 9,292,596 shares of Common Stock at prices ranging from $2.15 to $20.13 with expiration dates ranging up to March 12, 2013 and (ii) warrants to purchase 105,000 shares of Common Stock with exercise prices ranging from $5.00 to $7.13 and with expiration dates ranging up to July 17, 2006. Additionally, during the three month period ended March 31, 2003, securities not included in the computation of diluted earnings per share, because they would have an antidilutive effect due to the net loss for the period, were as follows: (i) options to purchase 857,639 shares of Common Stock at prices ranging from $1.22 to $2.06 with expiration dates ranging up to October 8, 2012 and (ii) Series B and C preferred stock convertible into 622,222 shares of Common Stock.

 

During the six month period ended March 31, 2004, securities not included in the computation of diluted earnings per share, because their exercise price exceeded the average market price during the period were as follows: (i) the notes convertible into 10,817,000 shares of Common Stock at a conversion price of $6.656 per share and which are convertible through July 15, 2008; (ii) options to purchase 3,150,000 shares of Common Stock at prices ranging from $6.00 to $20.13 with expiration dates ranging up to May 13, 2012 and (iii) warrants to purchase 10,000 shares of Common Stock with exercise price of $6.19 and with an expiration date of July 17, 2006. Additionally, during the six month period ended March 31,2004, potentially dilutive securities not included in the computation of diluted earnings per share, because they would have an antidilutive effect due to the net loss for the period, were as follows: (i) options to purchase 6,949,000 shares of Common Stock at prices ranging from $1.22 to $5.93 with expiration dates ranging up to March 10, 2014; (ii) Series B and C preferred stock convertible into 622,222 shares of Common Stock and (iii) warrants to purchase 45,000 shares of Common Stock with exercise prices ranging from $5.00 to $5.13 and with expiration dates ranging up to February 3, 2005.

 

During the six month period ended March 31, 2003, securities not included in the computation of diluted earnings per share, because their exercise price exceeded the average market price during the period were as follows: (i) options to purchase 9,557,383 shares of Common Stock at prices ranging from $2.15 to $20.13 with expiration dates ranging up to March 12, 2013 and (ii) warrants to purchase 105,000 shares of Common Stock with exercise prices ranging from $5.00 to $7.13 and with expiration dates ranging up to July 17, 2006. Additionally, during the six month period ended March 31, 2003, securities not included in the computation of diluted earnings per share, because they would have an antidilutive effect due to the net loss for

 

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the period, were as follows: (i) options to purchase 596,537 shares of Common Stock at prices ranging from $1.22 to $2.03 with expiration dates ranging up to October 8, 2012 and (ii) Series B and C preferred stock convertible into 622,222 shares of Common Stock.

 

Certain of the above securities contain anti-dilution provisions which may result in a change in the exercise price or number of shares issuable upon exercise or conversion of such securities.

 

C. Pro Forma Net Loss Information:

 

The Company applies Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees, and related interpretations, in accounting for its employee stock-based compensation plans. The Company has adopted the disclosure-only provisions of Statement of Financial Accounting Standards No. 148, Accounting for Stock-Based Compensation-Transition and Disclosure, an amendment of FASB Statement No. 123 (“SFAS No. 148”). Had compensation expense for the Company’s employee stock option plans been determined based on the fair value at the grant date for awards under these plans using a Black-Scholes option pricing model consistent with the methodology prescribed under SFAS No. 148, the Company’s net loss and net loss per share would have approximated the pro forma amounts indicated below:

 

    

Three months ended

March 31,


   

Six months ended

March 31,


 
     2004

    2003

    2004

    2003

 

As reported net loss

   $ (11,370,000 )   $ (2,966,000 )   $ (23,394,000 )   $ (8,397,000 )

Adjustment to compensation expense for stock-based awards

   $ (306,000 )   $ (248,000 )   $ (608,000 )   $ (518,000 )

Pro forma net loss

   $ (11,676,000 )   $ (3,214,000 )   $ (24,002,000 )   $ (8,915,000 )

As reported net loss per common share, basic and diluted