SECURITIES AND EXCHANGE COMMISSION
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.
| 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
(Registrants 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 Registrants common stock outstanding as of August 14, 2003 was 131,760,476.
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 |
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| 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. | Managements 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 |
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| 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 | |||||||
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 Managements 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 Managements 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.
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
4
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.
5
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.
6
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 Companys 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 Companys 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 Companys Annual Report on Form 10-K. Certain reclassifications have been made to the prior periods 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, Guarantors 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
7
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.
8
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