10.04.2007 12:00:00
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Mylan Increases Fiscal 2007 Adjusted Diluted EPS Guidance to $1.60 - $1.63 Excluding Any Contribution from the Recent Launch of Amlodipine Besylate
PITTSBURGH, April 10 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. today increased its fiscal 2007 adjusted diluted earnings per share guidance to a range of $1.60 to $1.63 from $1.50 to $1.55. This revised guidance range excludes any contribution from the March 23, 2007, launch of amlodipine besylate as well as other items identified below. While the full financial results for fiscal 2007, which ended on March 31, 2007, have not yet been finalized, the Company is increasing its existing fiscal 2007 guidance for the third time based on the continued strong performance of its base generic business as well as certain new products. At this time, the Company is not including any contribution from amlodipine besylate in the increased guidance range based on pending regulatory decisions from the U.S. Food and Drug Administration (FDA) related to the Company's 180 day exclusivity for this product. However, regardless of the regulatory decisions concerning exclusivity the Company expects that there will be additional upside to the revised guidance as a result of the amlodipine launch.
Robert J. Coury, Mylan's Vice Chairman and Chief Executive Officer, commented, "We are pleased to once again be increasing our guidance for fiscal 2007. We continue to experience very strong results from multiple products in our base portfolio and consistent with our expectations announced earlier in the fiscal year, no additional fentanyl transdermal products were launched, which resulted in additional upside to our forecast. The recent exclusive launch of amlodipine will further add to the already record results and gives us significant positive momentum entering the new fiscal year."
Consistent with how the Company has reported guidance in the past, Mylan's revised range of guidance also continues to exclude the impact of 1) the Matrix transaction that closed in January 2007, 2) the Company's recently completed public offerings of common stock and senior convertible notes, 3) expense related to stock-based compensation under Statement of Financial Accounting Standards No. 123R, which was adopted by the Company on April 1, 2006, 4) a net gain related to a foreign currency contract with respect to the Matrix transaction and 5) the net favorable settlement of certain litigation.
Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc., and a controlling interest in Matrix Laboratories Limited, India. Mylan develops, licenses, manufactures, markets and distributes an extensive line of generic and proprietary products.
This press release includes statements that constitute "forward-looking statements", including with regard to the Company's earnings expectations and anticipated impact of the amlodipine launch. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: any information, events or circumstances that may arise during the course of the finalization of the Company's financial results or the audit of its financial statements; the effect of any changes in customer and supplier relationships and customer purchasing patterns; the Company's ability to successfully develop, license or otherwise acquire and introduce new products on a timely basis in relation to competing product introductions; the Company's ability, or a partner's ability, to obtain required FDA approvals for new products on a timely basis; uncertainties regarding continued market acceptance of and demand for the Company's products; the results or effects of FDA or other regulatory investigations, including the Company's ability to continue to market and sell its products; the Company's periodic dependence on a relatively small group of products as a significant source of its net revenues or net income; unexpected delays in the Company's ability to submit applications to the FDA; risks inherent in legal proceedings; the effects of vigorous competition on commercial acceptance of the Company's products and their pricing, including, without limitation, the impact of the entry of generic competition for fentanyl; the Company's exposure to risks inherent in acquisitions or joint ventures; the high cost and uncertainty associated with compliance with extensive regulation of the pharmaceutical industry; the possibility that the calculation and reporting of amounts owed in respect of Medicaid and other governmental programs could be challenged, and that sanctions or penalties could be assessed; the significant research and development expenditures the Company makes to develop products, the commercial success of which is uncertain; risks inherent in global expansion, including operational, integration, compliance and regional economic risks; the possible loss of business from the Company's concentrated customer base; the risk that operating or financial restrictions imposed by the Company's credit facility or indenture for its senior notes may prevent the Company from taking certain actions, including capitalizing on significant business opportunities; the potential costs and product introduction delays that may result from use of legal, regulatory and legislative strategies by the Company's competitors and other third parties, including the practice of "authorized generics" and the use of citizen's petitions to delay or prevent product introductions; the Company's dependence on third party suppliers and distributors for raw materials; the possible negative effects of any interruption of manufacturing of products at the Company's principal facilities; the effects of consolidation of the Company's customer base; uncertainties regarding patent, intellectual and other proprietary property protections; the expending of substantial resources associated with litigation involving patent or other intellectual property protection of products; possible reductions in reimbursement rates for pharmaceutical products; possible negative effects on product pricing of current or future legislative or regulatory programs, including state Medicaid programs; uncertainties regarding the Company's performance under indemnification clauses in certain material agreements; inherent uncertainties involved in the estimates and judgments used in the preparation of financial statements, and the providing of estimates of financial measures, in accordance with GAAP and related standards; prevailing market conditions; changes in economic and financial conditions of the Company's business; and uncertainties and matters beyond the control of management, which could affect the Company's earnings guidance, as well as the subjectivity inherent in any probability weighted analysis underlying the Company's assumptions and estimates with respect to the future. These cautionary statements should be considered in connection with any subsequent written or oral forward-looking statements that may be made by the Company or by persons acting on its behalf and in conjunction with its periodic SEC filings. In addition, please refer to the cautionary statements and risk factors in the Company's Form 10-Q for the quarter ended December 31, 2006, and in its other filings with the SEC. The Company undertakes no obligation to update statements herein for revisions or changes after the date of this release.
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