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SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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 September 30, 2002

OR

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

  For the transition period from ____________ to __________.

Commission file number: 39040

ENDO PHARMACEUTICALS HOLDINGS INC.

(Exact Name of Registrant as Specified in Its Charter)

Delaware   13-4022871
(State or other jurisdiction of   (I.R.S. Employer
incorporation or organization)   Identification Number)

100 Painters Drive
Chadds Ford, Pennsylvania 19317
(Address of Principal Executive Offices)

(610) 558-9800
(Registrant’s Telephone Number, Including Area Code)

        Indicate by check ü whether the registrant: (1) has filed all reports required to be filed by Sections 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

        The aggregate number of shares of the Registrant’s common stock outstanding as of November 14, 2002 was 102,064,450.


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PART I FINANCIAL INFORMATION
Item 1. Financial Statements
CONSOLIDATED BALANCE SHEETS (UNAUDITED)
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Overview
Critical Accounting Policies
Results of Operations
Goodwill and Other Intangibles
Compensation Related to Stock Options
Other Events
Net Sales
Three Months Ended September 30, 2002 Compared to the Three Months Ended September 30, 2001
Nine Months Ended September 30, 2002 Compared to the Nine Months Ended September 30, 2001
Liquidity and Capital Resources
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Item 4. Controls and Procedures
PART II OTHER INFORMATION
Item 1. Legal Proceedings
Item 2. Changes in Securities and Use of Proceeds
Item 3. Defaults Upon Senior Securities
Item 4. Submission of Matters to a Vote of Security Holders
Item 5. Other Information
Item 6. Exhibits and Reports on Form 8-K
SIGNATURES
CERTIFICATIONS
EXHIBIT INDEX
EXHIBIT 11 STATEMENT REGARDING EARNINGS
EXHIBIT 99.1 CERTIFICATION OF CEO
EXHIBIT 99.2 CERTIFICATION OF CFO


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ENDO PHARMACEUTICALS HOLDINGS INC.

REPORT ON FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2002

TABLE OF CONTENTS

        Page
         
 
PART I.   FINANCIAL INFORMATION
     
Item 1.
Financial Statements      
 
Consolidated Balance Sheets (Unaudited)
     
     
September 30, 2002 and December 31, 2001
  1  
 
Consolidated Statements of Operations (Unaudited)
     
     
Three Months and Nine Months Ended September 30, 2002 and 2001
  2  
 
Consolidated Statements of Cash Flows (Unaudited)
     
     
Nine Months Ended September 30, 2002 and 2001
  3  
 
Notes to Consolidated Financial Statements (Unaudited)
  4  
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations   12  
 
Overview
  12  
 
Critical Accounting Policies
  12  
 
Results of Operations
  13  
     
Goodwill and Other Intangibles
  13  
     
Compensation Related to Stock Options
  14  
     
Other Events
  15  
     
Net Sales
  16  
     
Three Months Ended September 30, 2002 Compared to the Three Months Ended September 30, 2001
  17  
     
Nine Months Ended September 30, 2002 Compared to the Nine Months Ended September 30, 2001
  18  
     
Liquidity and Capital Resources
  20  
Item 3.
Quantitative and Qualitative Disclosures About Market Risk   21  
Item 4.
Controls and Procedures   21  


Table of Contents

PART II.   OTHER INFORMATION
     
Item 1.
Legal Proceedings   22    
Item 2.
Changes in Securities and Use of Proceeds   23    
Item 3.
Defaults Upon Senior Securities   23    
Item 4.
Submission of Matters to a Vote of Security Holders   23    
Item 5.
Other Information   23    
Item 6.
Exhibits and Reports on Form 8-K   24    
 
Signatures   25    
 
Certifications   26    


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Forward Looking Statements

        We have made “forward-looking statements” in this document within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. These statements, including estimates of future net sales and consolidated EBITDA contained in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” are subject to risks and uncertainties. Forward-looking statements include the information concerning our possible or assumed results of operations. Also, statements including words such as “believes,” “expects,” “anticipates,” “intends,” “estimates,” or similar expressions are forward-looking statements. We have based these forward-looking statements on our current expectations and projections about the growth of our business, our financial performance and the development of our industry. Because these statements reflect our current views concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors, as more fully described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Business” and elsewhere in this Report could affect our future financial results and could cause our actual results to differ materially from those expressed in forward-looking statements contained in this Report. Important factors that could cause our actual results to differ materially from the expectations reflected in the forward-looking statements in this Report include, among others:

•   our ability to successfully develop, commercialize and market new products;

•   results of clinical trials on new products;

•   competition for the business of our branded and generic products, and in connection with our acquisition of rights to intellectual property assets;

•   market acceptance of our future products;

•   government regulation of the pharmaceutical industry;

•   our dependence on a small number of products;

•   our dependence on outside manufacturers for the manufacture of our products;

•   our dependence on third parties to supply raw materials and to provide services for the core aspects of our business;

•   new regulatory action or lawsuits relating to the use of narcotics in most of our core products;

•   our exposure to product liability claims and product recalls and the possibility that we may not be able to adequately insure ourselves;

•   our ability to protect our proprietary technology;

•   our ability to successfully implement our acquisition strategy;

•   the availability of controlled substances that constitute the active ingredients of some of our products and products in development;

•   the availability of third-party reimbursement for our products; and

•   our dependence on sales to a limited number of large pharmacy chains and wholesale drug distributors for a large portion of our total net sales.

We do not undertake any obligation to update our forward-looking statements after the date of this Report for any reason, even if new information becomes available or other events occur in the future.

 


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PART I

FINANCIAL INFORMATION

Item 1.  Financial Statements

ENDO PHARMACEUTICALS HOLDINGS INC.
CONSOLIDATED BALANCE SHEETS (UNAUDITED)
(In thousands, except share data)

    September 30,   December 31,
    2002   2001
   
 
ASSETS                
CURRENT ASSETS:
               
Cash and cash equivalents
  $  36,545     $ 95,357  
Accounts receivable, net
    111,203       85,329  
Inventories
    33,259       27,766  
Prepaid expenses
    4,615       5,527  
Deferred income taxes
    42,574       26,946  
 
   
     
 
Total current assets
    228,196       240,925  
 
   
     
 
PROPERTY AND EQUIPMENT, Net
    10,477       9,883  
GOODWILL
    181,079       182,318  
OTHER INTANGIBLES, Net
    11,940       12,495  
DEFERRED INCOME TAXES
    24,678       23,420  
RESTRICTED CASH
            150  
OTHER ASSETS
    1,665       1,804  
 
   
     
 
TOTAL ASSETS
  $ 458,035     $ 470,995  
 
   
     
 
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
 
               
CURRENT LIABILITIES:
               
Accounts payable
  $ 46,977     $ 30,705  
Accrued expenses
    70,276       50,176  
Income taxes payable
    2,681       3,526  
Current portion of long-term debt
            91,259  
 
   
     
 
Total current liabilities
    119,934       175,666  
 
   
     
 
OTHER LIABILITIES
    231       207  
COMMITMENTS AND CONTINGENCIES
               
STOCKHOLDERS’ EQUITY
               
Preferred Stock, $.01 par value; 40,000,000 shares authorized; none issued Common Stock, $.01 par value; 175,000,000 shares authorized; 102,064,450 and 102,063,950 issued and outstanding at September 30, 2002 and December 31, 2001, respectively
    1,021       1,021  
 
               
Additional paid-in capital
    552,995       519,316  
Accumulated deficit
    (216,146 )     (225,215 )
 
   
     
 
Total Stockholders’ Equity
    337,870       295,122  
 
   
     
 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
  $ 458,035     $ 470,995  
 
   
     
 

See Notes to Consolidated Financial Statements

1


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ENDO PHARMACEUTICALS HOLDINGS INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(In thousands, except share data)

    Three Months Ended
September 30,
  Nine Months Ended
September 30,
   
 
    2002   2001   2002   2001
   
 
 
 
NET SALES
  $ 110,554     $ 66,268       285,482     $ 173,507  
COST OF SALES
    24,392       20,622       71,088       54,303  
 
   
     
     
     
 
GROSS PROFIT
    86,162       45,646       214,394       119,204  
 
   
     
     
     
 
COSTS AND EXPENSES:
                               
Selling, general and administrative
    28,753       19,588       79,898       54,931  
Research and development
    15,352       7,886       43,890       25,396  
Depreciation and amortization
    692       12,394       2,168       37,170  
Compensation related to stock options - primarily selling, general and administrative
    40,406       37,253       40,406       37,253  
Purchased in-process research and development
    13,334               13,334          
Manufacturing transfer fee
    9,000               9,000          
 
   
     
     
     
 
OPERATING (LOSS) INCOME
    (21,375 )     (31,475 )     25,698       (35,546 )
 
   
     
     
     
 
INTEREST EXPENSE, Net of interest income of $376, $607, $1,024 and $2,423 respectively
    1,031       2,686       4,302       9,129  
 
   
     
     
     
 
 
                               
(LOSS) INCOME BEFORE INCOME TAX (BENEFIT)
    (22,406 )     (34,161 )     21,396       (44,675 )
 
   
     
     
     
 
 
                               
INCOME TAX (BENEFIT)
    (4,098 )     (1,168 )     12,327       (175 )
 
   
     
     
     
 
 
                               
NET (LOSS) INCOME
  $ (18,308 )   $ (32,993 )   $ 9,069     $ (44,500 )
 
   
     
     
     
 
NET (LOSS) INCOME PER SHARE:
                               
 
                               
Basic
  $ (.18 )   $  (.37 )   $  .09     $  (.50 )
Diluted
  $ (.18 )   $  (.37 )   $  .09     $  (.50 )
 
                               
NET (LOSS) INCOME PRO FORMA TO EXCLUDE AMORTIZATION OF GOODWILL AND WORKFORCE-IN-PLACE:
  $ (18,308 )   $ (13,868 )   $ 9,069     $ (5,886 )
 
   
     
     
     
 
NET (LOSS) INCOME PER SHARE PRO FORMA TO EXCLUDE AMORTIZATION OF GOODWILL AND WORKFORCE-IN-PLACE:
                               
Basic
  $ (.18 )   $ (.16 )   $  .09     $  (.07 )
Diluted
  $ (.18 )   $ (.16 )   $  .09     $  (.07 )
WEIGHTED AVERAGE SHARES:
                               
Basic
    102,064       89,139       102,064       89,139  
Diluted
    102,064       89,139       102,245       89,139  

See Notes to Consolidated Financial Statements

2


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ENDO PHARMACEUTICALS HOLDINGS INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
(In thousands)

  Nine Months Ended
  September 30,
 
  2002   2001
 
 
OPERATING ACTIVITIES:
             
Net Income (Loss)
$ 9,069     $ (44,500 )
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
             
Depreciation and amortization
  2,168       37,170  
Purchased in-process research and development
  13,334          
Amortization of deferred financing costs
  290       1,165  
Accretion of promissory notes
  4,627       3,771  
Deferred income taxes
  (14,304 )     (1,100 )
Compensation related to stock options
  40,406       37,253  
Changes in assets and liabilities which provided (used) cash:
             
Accounts receivable
  (25,874 )     (1,107 )
Inventories
  (5,493 )