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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 June 30, 2003

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: 001-15989

ENDO PHARMACEUTICALS HOLDINGS INC.

(Exact Name of Registrant as Specified in Its Charter)
     
Delaware
(State or other jurisdiction of
incorporation or organization)
  13-4022871
(I.R.S. Employer
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 August 14, 2003 was 131,760,476.

 


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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
Three Months Ended June 30, 2003 Compared to the Three Months Ended June 30, 2002
Six Months Ended June 30, 2003 Compared to the Six Months Ended June 30, 2002
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
Exhibit Index
AMENDED AND RESTATED EXECUTIVE STOCKHOLDERS AGRMNT
STATEMENT RE COMPUTATION OF PER SHARE EARNINGS
302 CERTIFICATION: CEO
302 CERTIFICATION: CFO
906 CERTIFICATION: CEO
906 CERTIFICATION: CFO


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ENDO PHARMACEUTICALS HOLDINGS INC.

REPORT ON FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2003

TABLE OF CONTENTS

                   
              Page
             
         
PART I. FINANCIAL INFORMATION
       
Item 1.  
Financial Statements
       
       
Consolidated Balance Sheets (Unaudited) June 30, 2003 and December 31, 2002
    4  
       
Consolidated Statements of Operations (Unaudited) Three Months and Six Months Ended June 30, 2003 and 2002
    5  
       
Consolidated Statements of Cash Flows (Unaudited) Six Months Ended June 30, 2003 and 2002
    6  
       
Notes to Consolidated Financial Statements (Unaudited)
    7  
Item 2.  
Management’s Discussion and Analysis of Financial Condition and Results of Operations
    15  
       
Overview
    15  
       
Critical Accounting Policies
    15  
       
Results of Operations
    19  
       
Three Months Ended June 30, 2003 Compared to the Three Months Ended June 30, 2002
    20  
       
Six Months Ended June 30, 2003 Compared to the Six Months Ended June 30, 2002
    21  
       
Liquidity and Capital Resources
    22  
Item 3.  
Quantitative and Qualitative Disclosures About Market Risk
    23  
Item 4.  
Controls and Procedures
     

 


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              Page
             
         
PART II. OTHER INFORMATION
       
Item 1.  
Legal Proceedings
    25  
Item 2.  
Changes in Securities and Use of Proceeds
    26  
Item 3.  
Defaults Upon Senior Securities
    26  
Item 4.  
Submission of Matters to a Vote of Security Holders
    27  
Item 5.  
Other Information
    27  
Item 6.  
Exhibits and Reports on Form 8-K
    28  

 


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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)

                         
            June 30,   December 31,
            2003   2002
           
 
ASSETS                
CURRENT ASSETS:
               
 
Cash and cash equivalents
  $ 168,474     $ 56,902  
 
Accounts receivable, net
    119,417       119,496  
 
Inventories
    39,696       35,516  
 
Prepaid expenses
    4,839       4,354  
 
Deferred income taxes
    59,802       41,219  
 
   
     
 
   
Total current assets
    392,228       257,487  
 
   
     
 
PROPERTY AND EQUIPMENT, Net
    12,707       11,810  
GOODWILL
    181,079       181,079  
OTHER INTANGIBLES, Net
    35,649       36,755  
DEFERRED INCOME TAXES
    21,585       21,184  
OTHER ASSETS
    5,041       4,657  
 
   
     
 
TOTAL ASSETS
  $ 648,289     $ 512,972  
 
   
     
 
LIABILITIES AND STOCKHOLDERS’ EQUITY                
CURRENT LIABILITIES:
               
 
Accounts payable
  $ 57,447     $ 75,443  
 
Accrued expenses
    94,455       68,627  
 
Income taxes payable
    25,524       8,359  
 
   
     
 
   
Total current liabilities
    177,426       152,429  
 
   
     
 
OTHER LIABILITIES
    7,734       7,851  
 
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; 131,758,861 and 102,064,450 issued and outstanding at June 30, 2003 and December 31, 2002, respectively
    1,318       1,021  
 
Additional paid-in capital
    595,500       547,249  
 
Accumulated deficit
    (132,875 )     (194,402 )
 
Accumulated other comprehensive loss
    (814 )     (1,176 )
 
   
     
 
   
Total Stockholders’ Equity
    463,129       352,692  
 
   
     
 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
  $ 648,289     $ 512,972  
 
   
     
 

See Notes to Consolidated Financial Statements

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

                                     
        Three Months Ended   Six Months Ended
        June 30,   June 30,
       
 
        2003   2002   2003   2002
       
 
 
 
NET SALES
  $ 152,027     $ 107,902     $ 304,301     $ 174,928  
COST OF SALES
    26,258       27,805       53,835       46,696  
 
   
     
     
     
 
GROSS PROFIT
    125,769       80,097       250,466       128,232  
 
   
     
     
     
 
COSTS AND EXPENSES:
                               
 
Selling, general and administrative
    41,801       27,562       77,917       51,145  
 
Research and development
    9,438       15,142       21,502       28,538  
 
Depreciation and amortization
    1,365       691       2,717       1,476  
Compensation related to stock options – Primarily selling, general and administrative
                    48,514          
 
   
     
     
     
 
OPERATING INCOME
    73,165       36,702       99,816       47,073  
 
   
     
     
     
 
INTEREST EXPENSE, Net of interest income of $196, $341, $287 and $648, respectively
    22       1,649       153       3,271  
 
   
     
     
     
 
INCOME BEFORE INCOME TAX
    73,143       35,053       99,663       43,802  
INCOME TAX
    27,975       13,052       38,136       16,425  
 
   
     
     
     
 
NET INCOME
  $ 45,168     $ 22,001     $ 61,527     $ 27,377  
 
   
     
     
     
 
NET INCOME PER SHARE:
                               
   
Basic
  $ .34     $ .22     $ .49     $ .27  
   
Diluted
  $ .34     $ .22     $ .46     $ .27  
WEIGHTED AVERAGE SHARES:
                               
   
Basic
    131,734       102,064       125,014       102,064  
   
Diluted
    132,667       102,271       132,419       102,276  

See Notes to Consolidated Financial Statements.

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

                       
          Six Months Ended
          June 30,
         
          2003   2002
         
 
OPERATING ACTIVITIES:
               
 
Net Income
  $ 61,527     $ 27,377  
 
Adjustments to reconcile net income to net cash provided by operating activities:
               
   
Depreciation and amortization
    2,717       1,476  
   
Amortization of deferred financing costs
    199       191  
   
Accretion of promissory notes
            3,448  
   
Deferred income taxes
    (19,207 )     (1,847 )
   
Compensation related to stock options
    48,514          
 
Changes in assets and liabilities which provided (used) cash:
               
   
Accounts receivable
    79       (28,533 )
   
Inventories
    (4,180 )     (1,295 )
   
Other assets
    (476 )     2,190  
   
Accounts payable
    7,004       5,150  
   
Accrued expenses
    25,780       41,770  
   
Income taxes payable
    17,165       14,094  
   
Other liabilities
            10  
 
   
     
 
     
Net cash provided by operating activities
    139,122       64,031  
INVESTING ACTIVITIES:
               
 
Purchase of property and equipment
    (2,309 )     (827 )
 
License fees
    (25,000 )        
 
   
     
 
     
Net cash used in investing activities
    (27,309 )     (827 )
 
   
     
 
FINANCING ACTIVITIES:
               
 
Capital lease obligations repayments
    (277 )        
 
Exercise of pre-merger Endo warrants
    2          
 
Exercise of Endo Pharmaceuticals Holdings Inc. stock options
    34       4  
 
Repurchase of Class A Transferable and Class B Non-Transferable Warrants
            (6,730 )
 
   
     
 
     
Net cash used in financing activities
    (241 )     (6,726 )
 
   
     
 
NET INCREASE IN CASH AND CASH EQUIVALENTS
    111,572       56,478  
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD
    56,902       95,357  
 
   
     
 
CASH AND CASH EQUIVALENTS, END OF PERIOD
  $ 168,474     $ 151,835  
 
   
     
 
SUPPLEMENTAL INFORMATION:
               
 
Interest Paid
  $ 191     $ 134  
 
Income Taxes Paid
  $ 39,884     $ 4,180  

See Notes to Consolidated Financial Statements.

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ENDO PHARMACEUTICALS HOLDINGS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
FOR THE SIX MONTHS ENDED JUNE 30, 2003

1.   CONSOLIDATED FINANCIAL STATEMENTS

     In the opinion of management, the accompanying condensed consolidated financial statements of Endo Pharmaceuticals Holdings Inc. (the “Company” or “we”) and its subsidiaries, which are unaudited, include all normal and recurring adjustments necessary to present fairly the Company’s financial position as of June 30, 2003 and the results of operations and cash flows for the periods presented. The accompanying consolidated balance sheet as of December 31, 2002 is derived from the Company’s audited financial statements. Certain information and footnote disclosure normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted as promulgated by Accounting Principles Board Opinion No. 28 and Rule 10.01 of Regulation S-X under the Securities Act of 1933. These condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto as of and for the year ended December 31, 2002 contained in the Company’s Annual Report on Form 10-K. Certain reclassifications have been made to the prior period’s financial statements to conform with the classifications used in 2003.

2.   RECENT ACCOUNTING PRONOUNCEMENTS

     In January 2001, the Financial Accounting Standards Board (FASB) issued Statement of Financial Accounting Standards (SFAS) No. 144, Accounting for the Impairment or Disposal of Long-Lived Assets. We adopted the provisions of SFAS No. 144 on January 1, 2002, which had no material impact on our results of operations or financial position.

     In June 2001, the FASB, issued SFAS No. 141, Business Combinations, and SFAS No. 142, Goodwill and Other Intangible Assets. SFAS No. 141 was effective for all business combinations completed after June 30, 2001. SFAS No. 142 is effective for fiscal years beginning after December 15, 2001. SFAS No. 141 requires that all business combinations be accounted for under the purchase method only and that certain acquired intangible assets in a business combination be recognized as assets apart from goodwill. SFAS No. 142 establishes revised reporting requirements for goodwill and other intangible assets. See Note 3 to the Consolidated Financial Statements.

     In April 2002, the FASB issued SFAS No. 145, Rescission of FASB Statements No. 4, 44 and 64, Amendment of FASB Statement No. 13, and Technical Corrections. SFAS No. 145 (1) rescinds SFAS No. 4 and SFAS No. 64, which relate to the extinguishment of debt, (2) rescinds No. 44 relating to the accounting for intangible assets of motor carriers, and (3) amends SFAS No. 13 relating to the accounting for leases. SFAS No. 145 also amends certain other existing authoritative pronouncements to make various technical corrections, clarify meanings, or describe their applicability under changed conditions. Certain amounts were reclassified in accordance with SFAS No. 145 in the accompanying financial statements. We believe that the adoption of SFAS No. 145 will not have material impact on our results of operations or financial position.

     In July 2002, the FASB issued SFAS No. 146, Accounting for Costs Associated with Exit or Disposal Activities. SFAS No. 146 requires recognition of a liability for a cost associated with an exit or disposal activity when the liability is incurred, as opposed to when the entity commits to an exit plan under previous guidance. This statement is effective for exit or disposal activities initiated after December 31, 2002. We believe that the adoption of SFAS No. 146 will not have a material impact on our results of operations or financial position.

     In November 2002, the FASB issued FASB Interpretation No. 45, Guarantor’s Accounting and Disclosure Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of Others (FIN 45). FIN 45 requires that upon issuance of certain guarantees, a guarantor must recognize a liability for the fair value of an obligation assumed under the guarantee. FIN 45 also requires significant new disclosures, in both interim and annual financial statements, by a guarantor, about obligations associated with guarantees issued. FIN 45 disclosure requirements were effective for our fiscal year ended December 31, 2002 and the initial recognition and measurement provisions are

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applicable on a prospective basis to guarantees issued or modified after December 31, 2002. At June 30, 2003, we had no guarantees outstanding.

     In December 2002, the FASB issued SFAS No. 148, Accounting for Stock-Based Compensation — Transition and Disclosure. SFAS No. 148 amends SFAS No. 123, Accounting for Stock-Based Compensation, to provide alternative methods of transition for a voluntary change to the fair value based method of accounting for stock-based employee compensation. In addition, SFAS No. 148 amends the disclosure requirements of SFAS No. 123 to require prominent disclosures in both annual and interim financial statements about the method of accounting for stock-based employee compensation and the effect of the method used on reported results. We have not adopted the fair value based method of accounting for employee stock-based compensation.

3.   GOODWILL AND OTHER INTANGIBLES

     Effective January 1, 2002, we adopted the provisions of SFAS No. 142, Goodwill and Other Intangible Assets, and will no longer amortize goodwill and workforce in place.

     Our goodwill and other intangible assets consist of the following (in thousands):

                     
        June 30,   December 31,
        2003   2002
       
 
Goodwill
  $ 181,079     $ 181,079  
 
   
     
 
Amortizable Intangibles:
               
 
Licenses
  $ 36,000     $ 36,000  
 
Patents
    3,200       3,200  
 
   
     
 
 
    39,200       39,200  
Less accumulated amortization
    (3,551 )     (2,445 )
 
   
     
 
   
Other Intangibles, net
  $ 35,649     $ 36,755  
 
   
     
 

     Goodwill and other intangibles represents a significant portion of our assets and stockholders’ equity. As of June 30, 2003, goodwill and other intangibles comprised approximately 33% of our total assets and 47% of our stockholders’ equity. We assess the potential impairment of goodwill by comparing the fair value of goodwill to its carrying value for our one reporting unit. An impairment loss would be recognized when the estimated fair value is less than its carrying amount. As a result of the significance of goodwill, our results of operations and financial position in a future period could be negatively impacted should an impairment of goodwill occur.

     We have one reportable segment, pharmaceutical products. Goodwill arose as a result of the August 26, 1997 acquisition of certain branded and generic pharmaceutical products, related rights and certain assets of the then DuPont Merck Pharmaceutical Company (n/k/a Bristol-Myers Squibb Pharma Company) and the July 17, 2000 acquisition of Algos Pharmaceutical Corporation. Although goodwill arose in two separate transactions, the components of our operating segment have been integrated and are managed as one reporting unit. Our components extensively share assets and other resources with the other components of our business and have similar economic characteristics. In addition, our components do not maintain discrete financial information. Accordingly, the components of our business have been aggregated into one reporting unit and are evaluated as such for goodwill impairment. Goodwill is evaluated for impairment on an annual basis on January 1st of each year unless events or circumstances indicate that an impairment may have occurred between annual dates. Goodwill has been evaluated for impairment upon the adoption of SFAS No. 142 on January 1, 2002 and, based on the fair value of our reporting unit at such time, no impairment has been identified. On January 1, 2003, our goodwill was evaluated for impairment and, based on the fair value of our reporting unit at such time, no impairment was identified.

     Effective January 1, 2002, we reclassified the carrying amount of workforce-in-place as goodwill. The cost of license fees is capitalized and is being amortized using the straight-line method over the licenses’ estimated useful lives of seventeen to twenty years. The cost of acquired patents is capitalized and is being amortized using the straight-line method over their estimated useful lives of seventeen years.

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     Estimated amortization of intangibles for the five fiscal years subsequent to December 31, 2002 is as follows (in thousands):

       
2003
  $ 2,212
2004
    2,212
2005
    2,212
2006
    2,212
2007
    2,212

4.   COMPENSATION RELATED TO STOCK OPTIONS

Endo Pharma LLC 1997 Executive and Employee Stock Option Plans

     On November 25, 1997, the Company established the 1997 Employee Stock Option Plan and the 1997 Executive Stock Option Plan (c