Silke
16.02.2001, 08:56
Die schlechten Erwartungen auch im Pharmasektor häufen sich. Gestern erst Merck, was sich in dem Bullenmarkt nur sehr geringfügig ausgewirkt hatte. Dann nachbörsl. nochmals Schering mit einer Hammerwarnung. Mit ins Fahrwasser gezogen wurde Sepracor die eng mit Schering verbunden sind. Sepracor (SEPR) fiel daraufhin wie ein Stein um ca. 20%!
Heißer geht es kaum noch. Zuviele Firmen sind wiederum mit den Köpfen der Unternehmen verstrickt, die immer neuere Ertragswarnungen präsentieren!
cu
MM
UPDATE 3-Schering-Plough sees plant problems slicing earnings
THURSDAY, FEBRUARY 15, 2001 10:17:00 PM EST
(Adds details, executive and analyst comments in paragraphs 2-4,6-9,24 )
By Ransdell Pierson and Edward Tobin
NEW YORK, Feb 15 (Reuters) - Schering-Plough Corp. SGP said on Thursday it expects first-quarter earnings to drop as much as 15 percent from the 2000 quarter after U.S. regulators required the drug company to correct manufacturing problems, thus disrupting production.
Remedies mandated by the U.S. Food and Drug Administration (FDA) could delay the agency's approval of a new pill that Schering-Plough is counting on to preserve the company's $3 billion-a-year allergy medicine business.
Concerns about the lowered earnings forecast and a feared delay in launching the pill, Clarinex, helped spur a sell-off in company shares in after hours trade, analysts said.
Full-year 2001 sales and earnings will also be lower than expected as four of its largest plants in the United States and Puerto Rico undergo changes following inspections by the FDA, the company said.
The problems involve the failure to adhere to "Good Manufacturing Practices, primarily relating to production processes, controls and procedures," Schering-Plough said without disclosing which drugs may be affected.
Company spokesman Robert Consalvo told Reuters the plants are located in Union, N.J., Kenilworth, N.J., Manati, Puerto Rico, and Las Piedras, Puerto Rico.
"We have been undertaking improvement, enhancements and upgrades...which are causing temporary interruption of some production lines" at some facilities, Consalvo said, noting that none of the four plants had been closed.
But Banc of America Securities analyst Len Yaffe warned the drug maker may not shake off the regulatory headache until the second half of the year.
"This is a moderate to severe setback for Schering-Plough because it delays manufacturing of most of their products for the next several months. And it delays the approval for Clarinex," said Yaffe.
Schering-Plough said the deficiencies must be corrected before it can receive FDA approval for Clarinex (desloratadine) -- an allergy medicine that is the most important drug in the company's pipeline because it is meant to be the successor to its top-selling medicine Claritin, which brings in $3 billion a year worldwide.
The FDA has given a so-called "approvable letter" for Clarinex, indicating the drug has satisfied most of the requirements for final approval. But the drug has not yet received a final green light from the agency.
Kenilworth, N.J.-based Schering-Plough had hoped to ship Clarinex to pharmacies for the coming allergy season that begins next month, in order to begin switching over Claritin users to Clarinex well before the older allergy drug's patent expires in December 2002.
"This may affect their ability to switch patients from Claritin to Clarinex in an efficient manner," said Robert Hazlett, analyst at Robertson Stephens. "The more Schering can switch patients over in a timely manner, the better."
The uncertainly did not sit well with investors who ran for the hills in after hours trading, sending shares as low as $38.75 per share after closing Thursday at $48.32 on the New York Stock Exchange. Its 52-week trading range is $60 and $30.50.
Another stock that took a pounding in after hours activity was Marlborough, Mass.-based Sepracor Inc. SEPR, which licensed Schering-Plough the rights to the active ingredient of Clarinex in return for royalties on sales. It traded down at $55.50 from its close on the Nasdaq of $64.87.
Heißer geht es kaum noch. Zuviele Firmen sind wiederum mit den Köpfen der Unternehmen verstrickt, die immer neuere Ertragswarnungen präsentieren!
cu
MM
UPDATE 3-Schering-Plough sees plant problems slicing earnings
THURSDAY, FEBRUARY 15, 2001 10:17:00 PM EST
(Adds details, executive and analyst comments in paragraphs 2-4,6-9,24 )
By Ransdell Pierson and Edward Tobin
NEW YORK, Feb 15 (Reuters) - Schering-Plough Corp. SGP said on Thursday it expects first-quarter earnings to drop as much as 15 percent from the 2000 quarter after U.S. regulators required the drug company to correct manufacturing problems, thus disrupting production.
Remedies mandated by the U.S. Food and Drug Administration (FDA) could delay the agency's approval of a new pill that Schering-Plough is counting on to preserve the company's $3 billion-a-year allergy medicine business.
Concerns about the lowered earnings forecast and a feared delay in launching the pill, Clarinex, helped spur a sell-off in company shares in after hours trade, analysts said.
Full-year 2001 sales and earnings will also be lower than expected as four of its largest plants in the United States and Puerto Rico undergo changes following inspections by the FDA, the company said.
The problems involve the failure to adhere to "Good Manufacturing Practices, primarily relating to production processes, controls and procedures," Schering-Plough said without disclosing which drugs may be affected.
Company spokesman Robert Consalvo told Reuters the plants are located in Union, N.J., Kenilworth, N.J., Manati, Puerto Rico, and Las Piedras, Puerto Rico.
"We have been undertaking improvement, enhancements and upgrades...which are causing temporary interruption of some production lines" at some facilities, Consalvo said, noting that none of the four plants had been closed.
But Banc of America Securities analyst Len Yaffe warned the drug maker may not shake off the regulatory headache until the second half of the year.
"This is a moderate to severe setback for Schering-Plough because it delays manufacturing of most of their products for the next several months. And it delays the approval for Clarinex," said Yaffe.
Schering-Plough said the deficiencies must be corrected before it can receive FDA approval for Clarinex (desloratadine) -- an allergy medicine that is the most important drug in the company's pipeline because it is meant to be the successor to its top-selling medicine Claritin, which brings in $3 billion a year worldwide.
The FDA has given a so-called "approvable letter" for Clarinex, indicating the drug has satisfied most of the requirements for final approval. But the drug has not yet received a final green light from the agency.
Kenilworth, N.J.-based Schering-Plough had hoped to ship Clarinex to pharmacies for the coming allergy season that begins next month, in order to begin switching over Claritin users to Clarinex well before the older allergy drug's patent expires in December 2002.
"This may affect their ability to switch patients from Claritin to Clarinex in an efficient manner," said Robert Hazlett, analyst at Robertson Stephens. "The more Schering can switch patients over in a timely manner, the better."
The uncertainly did not sit well with investors who ran for the hills in after hours trading, sending shares as low as $38.75 per share after closing Thursday at $48.32 on the New York Stock Exchange. Its 52-week trading range is $60 and $30.50.
Another stock that took a pounding in after hours activity was Marlborough, Mass.-based Sepracor Inc. SEPR, which licensed Schering-Plough the rights to the active ingredient of Clarinex in return for royalties on sales. It traded down at $55.50 from its close on the Nasdaq of $64.87.