euro adhoc: Interim Announcement
Geschrieben am 07-11-2007 |
-------------------------------------------------------------------------------- Intermediate report of the management transmitted by euro adhoc. The issuer is responsible for the content of this announcement. --------------------------------------------------------------------------------
07.11.2007
Interim Announcement by Bayer Schering Pharma AG November 7, 2007
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 companies and their segments from fiscal 2007 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 September 30, 2007.
Operating business of Bayer Schering Pharma posts gratifying growth
In our Women's Healthcare business unit, the main growth drivers were the oral contraceptives of the Yasmin®/YAZ®/Yasminelle® product group, sales of which increased significantly. In July 2007, YAZ® received the first European approval in the Netherlands. It includes both, the contraception indication and the treatment of moderately severe acne in women.
In the Diagnostic Imaging business unit, sales of Ultravist® 370 mgI/ml recovered - particularly in Europe - after resuming marketing of the product.
In the Specialized Therapeutics business unit, sales of Betaferon®/Betaseron® to treat multiple sclerosis (MS) continued to rise.
The successful performance of our main sales drivers had a positive impact on the earnings of the Bayer Schering Pharma AG Group.
Integration of 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 last year, work started on integrating the Bayer Schering Pharma AG 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 since been amalgamated.
In the context of the integration of the Bayer Schering Pharma AG companies into the Bayer Group, a total of 37 companies were deconsolidated in the first three quarters of 2007 following their sale or an exchange of shares. 52 subsidiaries were sold to Bayer AG or its subsidiaries in the previous year.
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.
Bayer Schering Pharma acquires biologics manufacturing facility in the United States
In September 2007, Bayer Schering Pharma acquired a biologics manufacturing facility in Emeryville, California, from Novartis. Bayer will continue the production of Betaseron® at the Emeryville site, gaining full control of the entire manufacturing and process technology used in the production of Betaseron® and retaining the Emeryville work force. The amount paid for the transfer of the facility - including the Biologics License Application, which permits the manufacturing of biotechnological products - along with supplies and certain buildings, was U.S. $183 million (approx. EUR 137 million).
Bayer Schering Pharma will continue to pay Novartis royalties based on net sales of Betaseron® until October 2008. After this date, no more royalties will be due to Novartis on sales of Betaseron®.
Bayer Schering Pharma will assist Novartis with the application for marketing authorization for its own interferon beta-1b product in a 250 mcg dosage. Once regulatory approval has been granted, Bayer Schering Pharma will manufacture this product for Novartis from 2009 forward and receive in return a double- digit percentage royalty from Novartis.
BEYOND study: Results do not support regulatory filing for Betaferon® 500 mcg
In a large randomized trial (BEYOND: Betaferon® Efficacy Yielding Outcomes of a New Dose), the efficacy, tolerability and safety of a 500 mcg dose of Betaferon®/Betaseron® (interferon beta-1b) were investigated against the standard 250 mcg Betaferon®/Betaseron® dose and Copaxone® (glatiramer acetate) for the treatment of patients with relapsing-remitting multiple sclerosis. The recently published study results confirm that Betaferon®/Betaseron® 250 mcg represents the optimum dose and that it is highly effective and very well tolerated. They do not show a statistically significant superiority of Betaferon®/Betaseron® 500 mcg compared to Betaferon®/Betaseron® 250 mcg and Copaxone®. The company will therefore not apply for regulatory filing of a 500 mcg Betaferon® dose. This did not affect the balance sheets of Bayer Schering Pharma AG Group. For information on the financial impact on the Bayer Group, please refer to the Financial Report of Bayer AG as of September 30, 2007.
Legal Proceedings against Watson Laboratories initiated
In October 2007, Bayer Schering Pharma received notice that Watson Laboratories Inc. has filed an ANDA IV application with the U.S. FDA seeking approval of a generic version of Bayer Schering Pharma's YAZ® oral contraceptive product. The application claims that Bayer Schering Pharma's patent is invalid and/or that the respective generic product does not infringe it. Bayer Schering Pharma has filed a patent infringement suit against Watson claiming, inter alia, that the '531 patent has been infringed. Bayer Schering Pharma has market exclusivity rights for its YAZ® oral contraceptive product until March 2009.
Since mid-March 2007, the shares of Bayer Schering Pharma AG are no longer 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 the beginning of 2007, this Act obligates listed companies to publish interim announcements by the Board of Management twice a year. Since November 2006, the American Depositary Receipts (ADRs) of Bayer Schering Pharma AG are no longer traded on the New York Stock Exchange. 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 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. As far as obligations arise indirectly through the affiliation of Bayer Schering Pharma AG to the Bayer Group and the registration of Bayer AG with the SEC, Bayer Schering Pharma AG will continue to comply with these obligations. The Board of Management of Bayer Schering Pharma AG has resolved to have the secondary listing of Bayer Schering Pharma AG on the SWX Swiss Exchange (SWX) revoked due to low trading volumes. The delisting application has been granted by the SWX Swiss Exchange. Delisting will take place as of December 28, 2007. The last trading day in the primary segment of the SWX Swiss Exchange will be December 27, 2007. The bearer shares of Bayer Schering Pharma AG will remain listed on the Frankfurt Stock Exchange.
Berlin, November 7, 2007
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. 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 07.11.2007 09:17:11 --------------------------------------------------------------------------------
ots Originaltext: Bayer Schering Pharma AG Im Internet recherchierbar: http://www.presseportal.de
Further inquiry note:
Branche: Pharmaceuticals ISIN: DE0007172009 WKN: 717200 Börsen: Börse Stuttgart / regulated dealing Börse Hannover / regulated dealing Börse Frankfurt / official dealing/general standard Börse Berlin / official dealing Börse Hamburg / official dealing Börse Düsseldorf / official dealing Börse München / official dealing
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