has adjusted downward its fourth-quarter and full-year 2004 financial results following its decision to remove the multiple sclerosis drug Tysabri from the market.
Although the drug was pulled Feb. 28 and the fourth quarter closed Dec. 31, the company's adjustment involved inventory accounting that affected 2004's results.
Last week, the company
withdrew its 2005 financial guidance.
Biogen Idec and its partner,
, pulled the drug after receiving one confirmed death and one suspected case of patients, in clinical trials, contracting a rare central nervous system disorder after they had taken Tysabri and another MS drug, Avonex, made by Biogen Idec, for more than 24 months. The second case was later confirmed.
And last week,
a third case of the rare disease, known as PML, was identified in a patient who took Tysabri in a clinical trial for Crohn's disease, a chronic digestive disorder. The patient, who originally had been diagnosed as having brain cancer, died in December 2003.
The financial adjustments, which are enclosed in a 10-K report filed with the
Securities and Exchange Commission
late Thursday, aren't a formal restatement. They represent the difference between Biogen Idec's Feb. 7 press release about fourth-quarter and full-year results and the revised data in the 10-K statement. The revision isn't a surprise; the company told the SEC on March 17 it would delay filing its 10-K due to the withdrawal of Tysabri.
The revised fourth-quarter profit was $28.7 million, or 8 cents a share, on revenue of $587.8 million. Initially, the company said fourth-quarter profit was $48.4 million, or 14 cents a share, on revenue of $586 million.
The revised full-year results show a profit of $25.1 million, or 7 cents a share, on revenue of $2.212 billion. The initial figures included a profit of $44.8 million, or 13 cents a share, on revenue of $2.210 billion. All of the above results are reported on a GAAP basis.
Approved by the Food and Drug Administration in November, Tysabri provided only $3.1 million in sales for Biogen Idec by the end of 2004. Biogen Idec wrote down $19.1 million of Tysabri inventory that was on the company balance sheet as of Dec. 31, the 10-K statement says.
Biogen Idec and Elan continue to review all clinical trials in which patients used the drug to treat MS, Crohn's disease and rheumatoid arthritis. They say they will discuss with the FDA the test results and the prospects for returning Tysabri to the market.
Because Biogen Idec doesn't know when -- or how -- health regulators will act, it continues to make Tysabri. During the first quarter of 2005, Biogen Idec expects to expense "between $22 million to $25 million" of Tysabri being made during this quarter, the 10-K report says. "In subsequent periods, we will continue to assess Tysabri to determine if it needs to be expensed in light of existing information related to the potential future commercial availability of Tysabri and applicable accounting standards."