Bristol-Myers warns on 2002
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December 13, 2001: 5:36 p.m. ET
BMY sees $1.7 billion decline in annual sales of diabetes drug Glucophage.
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NEW YORK (CNN/Money) - Drugmaker Bristol-Myers Squibb Co. warned that earnings for 2002 will be well below current Wall Street expectations as it faces patent expiration for its diabetes drug, Glucophage.
Bristol-Myers (BMY]: Research, Estimates) said it now expects to earn between $2.25 and $2.35 per share for 2002. Analysts surveyed by First Call expected the company to earn $2.57, up about 7 percent from 2001.
Bristol-Myers Chairman and CEO Peter R. Dolan said in a statement the company is assuming a $1.7 billion decline in sales of Glucophage when the company loses exclusivity. The company said in conference call it projecting sales $2 billion in sales of Glucophage for 2001.
The U.S. House of Representatives is expected to vote next week on a bill regarding incentives for pediatric research which, if passed, would stop three years of additional patent protection for Glucophage.
The Senate on Wednesday voted to renew a law that provides a six-month marketing exclusivity period to drugmakers that commit to test their drugs for children.
But the bill contained language that would allow the U.S. Food and Drug Administration to approve copycat versions of drugs after that six-month period even when generic drugmakers do not have data relating to pediatric tests in their labels.
Dolan said in the conference call while he considers it "an unconstitutional violation of our Glucophage rights," he expects it to pass the House and be signed into law by U.S. President George W. Bush.
BMY affirms 01 and looks to 03
Bristol-Myers affirmed 2001 earnings expectations of $2.41 per share.
"We see 2002 as an important bridge year to improved performance in 2003 and beyond," Dolan saidt. "We are optimistic about the five new medicines that we are filing for regulatory approval in a 12-month period. The success of these filings and launches should make 2003 a strong growth year."
The message echoes Merck & Co. Inc.'s (MRK: down $0.58 to $57.94, Research, Estimates) announcement on Tuesday, when it reduced earnings guidance and called 2002 a "transition year."
Bristol-Myers declined to provide specific guidance for 2003 but said it was confident the year would mark another period of consistent growth.
The company said on Dec. 14 it intends to refile an application for approval of hypertension treatment Vanlev. The company pulled its first application for Vanlev in April amid safety concerns.
Among other products with blockbuster potential, Bristol-Myers noted schizophrenia treatment Aripiprazole, colon cancer treatment Erbitux, HIV/AIDS drug Atazanavir and antibiotic Desquinolone.
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