BIIB finally admits its Tysabri guidance has been unrealistic. (Most analysts and investors already knew this, of course: #msg-31249570.) 4Q08 Tysabri sales of $218M were down 8% from 3Q08, which is not exactly the trajectory one expects from a purported growth driver.
Friday February 6, 2009, 10:02 am EST By Toni Clarke
BOSTON (Reuters) - Biogen Idec Inc (NasdaqGS: BIIB ) scaled back growth projections for its multiple sclerosis drug Tysabri on Friday and said another patient has developed the potentially deadly brain infection known as PML.
Biogen reported higher fourth-quarter earnings but sales of Tysabri fell short of expectations and the company's shares fell more than 3.5 percent in early trading.
Jim Mullen, Biogen's chief executive officer, told analysts on the company's fourth-quarter earnings call that it will be "difficult" to achieve the company's previous forecast that 100,000 patients will be taking Tysabri by the end of 2010.
In addition, the company reported a new case of progressive multifocal leukoecephalopathy, or PML, a potentially deadly brain infection that has curbed the drug's sales.
Tysabri, which the company markets with Elan Corp Plc (NYSE: ELN), was temporarily withdrawn from the market in 2005 after it was linked with PML but reintroduced in July 2006 with stricter safety warnings. The newest case is the fifth since it was reintroduced and was contracted by a patient in Europe.
Cambridge, Massachusetts-based Biogen said its fourth-quarter net earnings rose 3 percent to $207 million, or 70 cents a share, from $201.2 million, or 67 cents a share, a year earlier.
Earnings excluding one-time items were 93 cents a share. Analysts had expected 92 cents, according to Reuters Estimates. Revenue rose to $1.07 billion from $893.3 million. Analysts were expecting revenue of $1.09 billion.
Total sales of Tysabri, which Biogen sells with Elan Corp Plc of Ireland, were $218 million, of which $115 million was in the United States and $103 million in the rest of the world. That fell short of the consensus estimate of total worldwide sales of Tysabri of $250 million.
"Tysabri sales numbers are going from bad to worse," said Corey Davis, an analyst at Natixis Bleichroeder in a research note. "We anticipate that the sales forecasts will now have to dip below $1 billion for 2009.
Biogen said it expected 2009 earnings excluding one-time items to be above $4 a share. Analysts had forecast $3.63 a share.
The company said it expected revenue growth at a high single-digit percentage rate for the year.‹
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”