SOURCE: Endo Pharmaceuticals

January 07, 2008 16:00 ET

Endo Pharmaceuticals Provides Financial Guidance for 2008

CHADDS FORD, PA--(Marketwire - January 7, 2008) - Endo Pharmaceuticals Holdings Inc. (NASDAQ: ENDP), a market leader in pain management, today provided financial guidance for the fiscal year ending December 31, 2008, as follows:

--  Driven primarily by the ongoing success of its lead product,
    LIDODERM®, and the continuing growth of OPANA® ER, OPANA® and
    FROVA®, Endo expects its 2008 net sales to be between $1.215 billion and
    $1.240 billion. The mid-point of the 2008 net sales guidance represents an
    approximately 16% increase from the mid-point of the company's 2007
    guidance of $1.0625 billion. Consistent with industry practice, Endo will
    no longer provide guidance on individual product sales.
--  Excluding milestone payments to partners and the expensing of stock-
    based compensation charges, adjusted diluted earnings per share are
    expected to be between $2.10 and $2.15 in 2008. The mid-point of this
    guidance represents an approximately 17% increase from the mid-point of the
    company's adjusted diluted earnings per share guidance for 2007 of $1.815.

"Our focus in 2008 will be on two key value drivers for our business," said President and Chief Executive Officer Peter A. Lankau. "First is operational excellence in the accomplishment of our key objectives across every facet of our business, from driving the continuing growth of our on-market products to further advancing the development of our pipeline. Second is ongoing execution of our strategic plan, which will add core capabilities in sourcing new assets, developing those assets from earlier stages through to market and commercialization as well as enhancing our enabling capabilities in people, systems and business tools." Lankau further noted, "Our priority for 2008 is to enhance our overall portfolio, including expanding our pipeline by making significant investments in new product opportunities as outlined in our strategic plan. Additionally, we look forward to benefiting from the infrastructure enhancements we made in 2007 to help promote strong top- and bottom-line growth, not only this year but over the long term."

The company expects its gross profit margin percentage for 2008 to include the impact of the expected initiation of royalty payments to Penwest Pharmaceuticals Inc. on net sales of OPANA ER. The company anticipates that selling, general and administrative expenses will remain relatively constant with 2007 levels. Investments in research & development, however, are expected to increase significantly in 2008 as Endo advances its pipeline by conducting clinical trial programs for its priority development products EN3269 -- the topical ketoprofen patch, EN3285 -- NAC oral rinse, EN3270 -- the transdermal sufentanil patch, and the recently acquired AZ-003 inhaled fentanyl (also known as EN3294), as well as the completion of safety studies for EN3267 -- RAPINYL™.

Endo's 2008 adjusted diluted earnings guidance excludes non-recurring items and the potential impact of possible future company or product acquisitions or licensing agreements. "We expect to continue to be active on the business development front in 2008, while management and our Board of Directors continue to monitor the company's cash position and strong balance sheet," Lankau said.

"On the business development front, we are targeting products that are clinically innovative and differentiated, including earlier-stage opportunities such as our recent license of AZ-003 (Staccato® fentanyl) from Alexza Pharmaceuticals, which we announced on December 27, 2007," said Lankau. "Consistent with our goal of becoming THE leading pain company, we are evaluating and pursuing business development opportunities to further our expertise in pain management and other select specialty-focused therapeutic areas that have the potential to provide growth and diversification of our revenue stream, resulting in enhanced shareholder value."

About Endo

Endo Pharmaceuticals Holdings Inc. is a fully integrated specialty pharmaceutical company with market leadership in pain management products. Through its wholly owned subsidiary, Endo Pharmaceuticals Inc., the company researches, develops, produces and markets a broad product offering of both branded and generic pharmaceuticals, meeting the needs of healthcare professionals and consumers alike. More information, including this and past press releases of Endo Pharmaceuticals Holdings Inc., is available at

Forward-Looking Statements

This press release contains forward-looking statements, within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended, that are based on management's beliefs and assumptions, current expectations, estimates and projections. Statements that are not historical facts, including statements which are preceded by, followed by, or that include, the words "believes," "anticipates," "plans," "expects" or similar expressions and statements are forward-looking statements. Endo's estimated or anticipated future results, product performance or other non-historical facts are forward-looking and reflect Endo's current perspective on existing trends and information. Many of the factors that will determine the Company's future results are beyond the ability of the Company to control or predict. These statements are subject to risks and uncertainties and, therefore, actual results may differ materially from those expressed or implied by these forward-looking statements. The reader should not rely on any forward-looking statement. The Company undertakes no obligation to update any forward-looking statements whether as a result of new information, future events or otherwise. Several important factors, in addition to the specific factors discussed in connection with these forward-looking statements individually, could affect the future results of Endo and could cause those results to differ materially from those expressed in the forward-looking statements contained in this press release. Important factors that may affect future results include, but are not limited to: market acceptance of the Company's products and the impact of competitive products and pricing; dependence on sole source suppliers; the success of the Company's product development activities and the timeliness with which regulatory authorizations and product launches may be achieved; successful compliance with extensive, costly, complex and evolving governmental regulations and restrictions; the availability on commercially reasonable terms of raw materials and other third party manufactured products; exposure to product liability and other lawsuits and contingencies; dependence on third party suppliers, distributors and collaboration partners; the ability to timely and cost effectively integrate acquisitions; uncertainty associated with pre-clinical studies and clinical trials and regulatory approval; uncertainty of market acceptance of new products; the difficulty of predicting FDA approvals; risks with respect to technology and product development; the effect of competing products and prices; uncertainties regarding intellectual property protection; uncertainties as to the outcome of litigation; a determination by a regulatory agency that we are engaging in inappropriate sales or marketing activities, including promoting the "off-label" use of our products; changes in operating results; impact of competitive products and pricing; product development; changes in laws and regulations; customer demand; possible future litigation; availability of future financing and reimbursement policies of government and private health insurers and others; and other risks and uncertainties detailed in Endo's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K filed with the SEC on March 1, 2007. Readers should evaluate any statement in light of these important factors.