euro adhoc: Bayer Schering Pharma AG / Interim Announcement
Geschrieben am 28-04-2008 |
-------------------------------------------------------------------------------- Intermediate report of the management transmitted by euro adhoc. The issuer is responsible for the content of this announcement. --------------------------------------------------------------------------------
28.04.2008
Interim Announcement by Bayer Schering Pharma AG April 28, 2008
Bayer Schering Pharma AG maintains its growth course
On account of the integration of Bayer Schering Pharma AG into the Bayer Group and the associated changes in legal-entity structure, the absolute values for the Bayer Schering Pharma AG Group companies and their segments are no longer comparable with the corresponding prior-year periods. This data therefore will not be provided. Net sales of key Bayer Schering Pharma products - including business now treated as that of other Bayer Group companies - are given in the Bayer Group Financial Report as of March 31, 2008.
Bayer Schering Pharma posts gratifying operating performance
The principle growth driver in our Women's Healthcare business unit was the Yasmin®/YAZ®/Yasminelle® family of oral contraceptive products.
In the Diagnostic Imaging business unit, sales of Ultravist® grew, although prior-year sales were depressed by temporary interruption of the distribution of the Ultravist® 370 mgl/ml formulation.
In the Specialized Therapeutics business unit, sales of Betaferon®/Betaseron® for the treatment of multiple sclerosis (MS) increased yet again.
Integration of the Bayer Schering Pharma AG Group into the Bayer Group
With the registration of the domination and profit-and-loss transfer agreement at the end of October 2006, work started on integrating the Bayer Schering Pharma AG Group companies into the Bayer Group and merging the pharmaceuticals business of Bayer Schering Pharma AG and its subsidiaries with that of the Bayer Group. Both of these businesses are to be managed uniformly in the interest of the Bayer Group and its subgroup Bayer HealthCare. All key functional areas, especially research and development, procurement, production, sales, marketing and administration, have now been amalgamated.
In the course of integrating the Bayer Schering Pharma AG Group companies into the Bayer Group, one company was deconsolidated in the first quarter of 2008 following amalgamation with a Bayer Group company. In this context, a total of 89 companies were deconsolidated in 2006 and 2007 following their sale or an exchange of shares.
To facilitate implementation of the necessary restructuring measures, Bayer Schering GmbH - as the majority stockholder of Bayer Schering Pharma AG - is seeking the transfer of all shares in Bayer Schering Pharma AG. Under a resolution adopted by the Extraordinary Stockholders' Meeting of Bayer Schering Pharma AG on January 17, 2007, Bayer Schering GmbH, a wholly owned subsidiary of Bayer AG and majority stockholder of Bayer Schering Pharma AG, is to acquire the shares held by the minority stockholders in return for compensation in cash of EUR 98.98 per share. Dissenting stockholders are seeking to have the stockholder resolution set aside or to have it declared null and void.
Legal risks
To find out more about Bayer Schering Pharma AG's overall risk situation, please refer to pages 48-55 of the Bayer Schering Pharma AG Annual Report 2007, which can be downloaded free of charge at www.schering.de. Since the Bayer Schering Pharma AG Annual Report 2007 was published, the following significant changes have occurred in respect of the legal risks:
Yasmin®: On page 50 of the Bayer Schering Pharma AG Annual Report 2007, we reported that Bayer Schering Pharma filed a suit against Barr Pharmaceuticals Inc. and Barr Laboratories Inc. in U.S. federal court, alleging patent infringement by Barr for the intended generic version of Bayer Schering Pharma's Yasmin® oral contraceptive product in the United States. In June 2005, Barr filed its counterclaim seeking to invalidate Bayer Schering Pharma's patent. In early March 2008, the U.S. federal court invalidated Bayer Schering Pharma AG's ´531 patent for Yasmin®. Bayer Schering Pharma has appealed this ruling.
In March 2008, Bayer HealthCare Pharmaceuticals Inc. and Bayer Schering Pharma AG received two notices of an Abbreviated New Drug Application (ANDA) pursuant to which Watson Laboratories Inc. and Sandoz Inc. are each seeking approval to market a generic version of Bayer Schering Pharma's oral contraceptive Yasmin® in the United States. Bayer Schering Pharma has filed a suit against Watson and Sandoz in U.S. federal court alleging patent infringement.
YAZ®: On page 50 of the Bayer Schering Pharma AG Annual Report 2007, we reported that, in January 2007, Barr Laboratories Inc. filed an ANDA application with the U.S. FDA seeking approval of a generic version of Bayer Schering Pharma's YAZ® oral contraceptive in the United States. In October 2007, Bayer Schering Pharma was notified that Watson Laboratories Inc. had also filed an ANDA application for a generic version of YAZ® in the United States. Both applications claim that the Bayer Schering Pharma patents are invalid and/or that the respective generic product does not infringe them. Bayer Schering Pharma has filed a patent infringement suit against Watson claiming, inter alia, that Bayer Schering Pharma's ´531 patent has been infringed. Bayer Schering Pharma's ´531 patent is also at issue in the patent infringement suit against Barr, mentioned previously, involving the oral contraceptive Yasmin®. Bayer Schering Pharma is currently evaluating the impact of the court's decision regarding Yasmin® on YAZ®. However, regardless of the outcome of the court's decision invalidating the company's ´531 patent with regard to Yasmin®, Bayer Schering Pharma retains marketing exclusivity for YAZ® as an oral contraceptive in the United States until March 16, 2009. No generic manufacturer can lawfully market a generic version of YAZ® for an oral contraceptive indication until after March 16, 2009.
Since mid-March 2007, the shares of Bayer Schering Pharma AG have not been admitted to the Prime Standard Segment of the Frankfurt Stock Exchange where there are additional reporting obligations. Since then, Bayer Schering Pharma AG has not been subject to these additional reporting obligations, but only to the general reporting requirements of the German Stock Exchange Admission Regulations and the provisions of the German Securities Trading Act (WpHG). Effective since 2007, the WpHG obligates listed companies to publish interim announcements by the Board of Management twice a year. The American Depositary Receipts (ADRs) of Bayer Schering Pharma AG have not been traded on the New York Stock Exchange since November 2006. In addition, the registration of Bayer Schering Pharma AG shares with the U.S. Securities and Exchange Commission ended as of September 2, 2007. Bayer Schering Pharma AG is therefore no longer subject to the obligations in connection with the registration as demanded by U.S. stock corporation laws including the Sarbanes-Oxley Act of 2002. In particular, Bayer Schering Pharma AG will no longer publish Annual Reports on Form 20-F. The secondary listing of Bayer Schering Pharma AG on the SWX Swiss Exchange was revoked as of December 28, 2007. The bearer shares of Bayer Schering Pharma AG will continue to be listed on the Frankfurt Stock Exchange.
Berlin, April 28, 2008
Bayer Schering Pharma Aktiengesellschaft The Board of Management
Forward-Looking Statements This Interim Announcement contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management and Bayer Schering Pharma AG management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
end of announcement euro adhoc --------------------------------------------------------------------------------
ots Originaltext: Bayer Schering Pharma AG Im Internet recherchierbar: http://www.presseportal.de
Further inquiry note:
Branche: Pharmaceuticals ISIN: DE0007172009 WKN: 717200 Börsen: Börse Berlin / regulated dealing Börse Stuttgart / regulated dealing Börse Düsseldorf / regulated dealing Börse Hannover / regulated dealing Börse München / regulated dealing Börse Frankfurt / regulated dealing/general standard
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