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Even promising results from preclinical and early clinical studies do not always accurately predict results in later, large-scale trials. To demonstrate the safety and effectiveness of a product. Preclinical and clinical studies may fail Before obtaining regulatoryĪpprovals for the sale of any of our products, other than generic products, we must demonstrate through preclinical studies and clinical trials that the product is safe and effective for each intended use. Timing and results of clinical trials to demonstrate the safety and efficacy of products as well as the FDA’s approval of products are uncertain. If we do not do so successfully, our growth and development will be impaired.

Our growth and development will depend on our ability to successfully develop, commercialize and market new products, including both our own products and those developed with ourĬollaboration partners. Results to differ materially from the expectations reflected in the forward-looking statements in this Report include, among others: Important factors that could cause our actual Investors should note that many factors, as more fully described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” andĮlsewhere 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. These forward-looking statements involve risks and uncertainties. Because these statements reflect our current views concerning future events, We have based theseįorward-looking statements on our current expectations and projections about the growth of our business, our financial performance and the development of our industry. Also, statements including words such as “believes,” “expects,” “anticipates,” “intends,” “estimates,” or similar expressions are forward-looking statements. Forward-looking statements include the information concerning our possible or assumed results of “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” are subject to risks and uncertainties. These statements, including estimates of future net sales, future net income and future earnings per share, contained in the section titled Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. We have made “forward-looking statements” in this document within the meaning of Section 27A of the Submission of Matters to a Vote of Security Holders Unregistered Sales of Equity Securities and Use of Proceeds Quantitative and Qualitative Disclosures About Market Risk Nine Months Ended SeptemCompared to the Nine Months Ended September 30, 2004 Three Months Ended SeptemCompared to the Three Months Ended September 30, 2004 Management’s Discussion and Analysis of Financial Condition and Results of OperationsĬritical Accounting Policies and Estimates

Notes to Condensed Consolidated Financial Statements (Unaudited) Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date:Ĭommon Stock, $.01 par value: 132,716,065 shares as of November 3, 2005.Ĭondensed Consolidated Balance Sheets (Unaudited) Septemand December 31, 2004Ĭondensed Consolidated Statements of Operations (Unaudited) Three and Nine Months Ended Septemand 2004Ĭondensed Consolidated Statements of Cash Flows (Unaudited) Nine Months Ended Septemand 2004 Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the 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. Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Sections 13 or 15(d) of the Securities Exchange Act (Former name, former address and former fiscal year, if changed since last report) (Registrant’s Telephone Number, Including Area Code) (Exact Name of Registrant as Specified in Its Charter) TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934įOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2005. Endo Pharmaceuticals Holdings Inc-Form 10-Q