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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 December 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 February 8, 2005


Common Stock $.001 par value   46,969,811 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 December 31, 2004 and September 30, 2004

   3
   

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

   4
   

     Consolidated Statements of Cash Flows for the Three Months ended December 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

   8

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 5.

 

Other Information

   16

Item 6.

 

Exhibits

   16

SIGNATURES

   17

 

2


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PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

INDEVUS PHARMACEUTICALS, INC.

CONSOLIDATED BALANCE SHEETS

(Unaudited)

(Amounts in thousands except share data)

     December 31,
2004


    September 30,
2004


 
ASSETS                 

Current assets:

                

Cash and cash equivalents

   $ 106,553     $ 127,099  

Marketable securities

     24,498       26,423  

Accounts receivable

     2,638       7,042  

Inventories

     2,883       1,160  

Prepaids and other current assets

     3,928       3,082  
    


 


Total current assets

     140,500       164,806  

Marketable securities

     3,041       3,486  

Property and equipment, net

     698       546  

Insurance claim receivable

     1,258       1,258  

Prepaid debt issuance costs

     2,338       2,503  

Other assets

     1,205       1,239  
    


 


Total assets

   $ 149,040     $ 173,838  
    


 


LIABILITIES                 

Current liabilities:

                

Accounts payable

   $ 4,572     $ 6,361  

Accrued expenses

     13,447       13,707  

Accrued interest

     2,075       950  

Deferred revenue

     12,500       12,500  
    


 


Total current liabilities

     32,594       33,518  

Convertible Notes

     72,000       72,000  

License fees payable

     100       100  

Deferred revenue

     128,125       131,250  

Minority interest

     8       8  
STOCKHOLDERS’ DEFICIT                 

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

                

Series B, 239,425 shares issued and outstanding (liquidation preference at December 31, 2004 $3,026)

     3,000       3,000  

Series C, 5,000 shares issued and outstanding (liquidation preference at December 31, 2004 $502)

     500       500  

Common stock, $.001 par value, 80,000,000 shares authorized; 47,825,896 shares issued at December 31 and September 30, 2004

     48       48  

Additional paid-in capital

     308,293       309,050  

Accumulated deficit

     (390,052 )     (368,903 )

Accumulated other comprehensive loss

     (200 )     (131 )

Treasury stock, at cost, 870,335 and 1,057,125 shares at December 31 and September 30, 2004, respectively

     (5,376 )     (6,602 )
    


 


Total stockholders’ deficit

     (83,787 )     (63,038 )
    


 


Total liabilities and stockholders’ deficit

   $ 149,040     $ 173,838  
    


 


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

 

3


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INDEVUS PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

For the three months ended December 31, 2004 and 2003

(Unaudited)

(Amounts in thousands except per share data)

 

     Three months ended
December 31,


 
     2004

    2003

 

Revenues:

                

Product revenue

   $ 3,467     $ 785  

Contract and license fees

     2,296       142  
    


 


Total revenues

     5,763       927  

Costs and expenses:

                

Cost of product revenue

     2,480       315  

Research and development

     5,878       7,554  

Marketing, general and administrative

     17,481       4,016  
    


 


Total costs and expenses

     25,839       11,885  

Loss from operations

     (20,076 )     (10,958 )

Investment income

     674       222  

Interest expense

     (1,292 )     (1,292 )

Minority interest

     —         4  
    


 


Loss before income taxes

     (20,694 )     (12,024 )

Provision for income taxes

     (455 )     —    
    


 


Net loss

   $ (21,149 )   $ (12,024 )
    


 


Net loss per common share, basic and diluted

   $ (0.44 )   $ (0.25 )
    


 


Weighted average common shares outstanding, basic and diluted

     47,826       47,211  

 

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

 

4


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INDEVUS PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

For the three months ended December 31, 2004 and 2003

(Unaudited)

(Amounts in thousands)

 

     For the three months ended
December 31,


 
     2004

    2003

 

Cash flows from operating activities:

                

Net loss

   $ (21,149 )   $ (12,024 )

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

                

Depreciation and amortization

     80       6  

Amortization of convertible note issuance costs

     165       165  

Changes in assets and liabilities:

                

Accounts receivable

     4,404       (53 )

Inventories

     (1,723 )     —    

Prepaid and other assets

     (824 )     (614 )

Accounts payable

     (1,789 )     (667 )

Deferred revenue

     (3,125 )     —    

Accrued expenses and other liabilities

     855       2,320  
    


 


Net cash used in operating activities

     (23,106 )     (10,867 )
    


 


Cash flows from investing activities:

                

Capital expenditures

     (232 )     (5 )

Purchase of marketable securities

     —         (3,210 )

Proceeds from maturities and sales of marketable securities

     2,314       2,692  
    


 


Net cash provided by (used in) investing activities

     2,082       (523 )
    


 


Cash flows from financing activities:

                

Net proceeds from issuance of common and treasury stock

     478       371  
    


 


Net cash provided by financing activities

     478       371  
    


 


Net change in cash and cash equivalents

     (20,546 )     (11,019 )

Cash and cash equivalents at beginning of period

     127,099       57,717  
    


 


Cash and cash equivalents at end of period

   $ 106,553     $ 46,698  
    


 


 

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

 

5


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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, 2004.

 

Certain prior year amounts have been reclassified to conform to fiscal 2005 classifications.

 

Indevus is a biopharmaceutical company engaged in the development and commercialization of a diversified portfolio of product candidates, including SANCTURA (trospium chloride), approved by the U.S. Food and Drug Administration for the treatment of overactive bladder (“OAB”), and multiple compounds in clinical development.

 

B. Inventories

 

Inventories are stated at the lower of cost or market with cost determined under the first-in, first-out (“FIFO”) method.

 

The components of inventory are as follows:

 

     December 31,
2004


   September 30,
2004


Raw materials

   $ 2,148,000    $ 488,000

Finished goods

     735,000      672,000
    

  

     $ 2,883,000    $ 1,160,000
    

  

 

Inventories consist solely of SANCTURA. Raw materials consist of tablets of SANCTURA in bulk form purchased from the Company’s supplier, Madaus A.G. Finished goods consist of SANCTURA tablets packaged in bottles for resale and blister packages for distribution as samples.

 

C. Basic and Diluted Loss per Common Share

 

During the three month period ended December 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 1,306,000 shares of Common Stock at prices ranging from $6.68 to $20.13 with expiration dates ranging up to September 28, 2014. Additionally, during the three month period ended December 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 $6.61 with expiration dates ranging up to August 17, 2014; (ii) Series B and C preferred stock convertible into 622,222 shares of Common Stock and (iii) warrants to purchase 10,000 shares of Common Stock with an exercise price of $6.19 and an expiration date of July 17, 2006.

 

During the three month period ended December 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) 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 3,206,000 shares of Common Stock at prices ranging from $5.72 to $20.13 with expiration dates ranging up to May 13, 2012 and (iii) warrants to purchase 55,000 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 December 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 6,985,000 shares of Common Stock at prices ranging from $1.22 to $5.32 with expiration dates ranging up to June 3, 2013; 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.

 

6


Table of Contents

INDEVUS PHARMACEUTICALS, INC.

NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

 

D. 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

December 31,


 
     2004

    2003

 

As reported net loss

   $ (21,149,000 )   $ (12,024,000 )

Noncash compensation expense included in reported net income, net of tax

   $ —       $ —    

Compensation expense determined under the fair-value method for all awards, net of tax

   $ (665,000 )   $ (302,000 )

Pro forma net loss

   $ (21,814,000 )   $ (12,326,000 )

As reported net loss per common share:

                

Basic

   $ (0.44 )   $ (0.25 )

Diluted

   $ (0.44 )   $ (0.25 )

Pro forma net loss per common share:

                

Basic

   $ (0.46 )   $ (0.26 )

Diluted

   $ (0.46 )   $ (0.26 )

 

E. Comprehensive Loss

 

Comprehensive loss for the three month periods ended December 31, 2004 and 2003, respectively, is as follows:

 

    

Three Months Ended

December 31,


 
     2004

    2003

 

Net loss

   $ (21,149,000 )   $ (12,024,000 )

Change in unrealized net gain or (loss) on investments

     (69,000 )     (30,000 )
    


 


Comprehensive loss

   $ (21,218,000 )   $ (12,054,000 )
    


 


 

F. Facilities Lease

 

In December 2004, the Company entered into a lease agreement for new corporate headquarters in Lexington, MA. This lease for approximately 45,000 square feet provides for an initial term of 66 months, commencing upon occupancy. The aggregate minimum rental commitment is approximately $5,400,000. The Company expects to occupy its new facilities in June 2005, prior to the April 2007 expiration of the lease period of its current facilities. The Company expects to record a charge related to the future nonutilization of its current facilities in the period when the Company ceases to use such facilities.

 

G. SANCTURA

 

In April 2004, we entered into a co-promotion and licensing agreement with Odyssey Pharmaceuticals, Inc., a specialty branded subsidiary of PLIVA d.d. (“PLIVA”) (the “PLIVA Agreement”) for the U.S. commercialization of SANCTURA (trospium chloride) launched in August 2004. Pursuant to the PLIVA Agreement, on September 27, 2004, the Company made formal notification to PLIVA with respect to the termination of the co-promotion period of the Agreement, thereby converting the Agreement into a royalty-bearing structure (the “Conversion”). The Conversion became effective on November 29, 2004 as of which date approximately 200 of the Company’s primary care sales representatives became PLIVA employees. Under this royalty-bearing structure, the Company receives royalties from PLIVA based on net sales of SANCTURA, and PLIVA is responsible for promotional and advertising costs. Additionally, for the three years commencing November 29, 2004, PLIVA commenced