Shire's Search for Tranquility

Shire executives said the recent FDA advisory panel simply reviewed old data, even though some news organizations gave the impression that new research had been presented.

Emmens said he believed the FDA was holding advisory panel meetings because Canada had temporarily suspended sales of Adderall XR 12 months ago after reviewing reports of 20 sudden deaths worldwide. At the time, the FDA said it was familiar with the reports and saw no need to take any action. Canada reinstated the drug last August.

Financial Results

Assumptions about the ADHD drugs and the launching of new drugs prompted Shire to warn that selling, general and administrative costs will jump to a range of $770 million to $800 million this year from $631 million last year. The extra spending will be worth it, Emmens said, because Shire has "a full pipeline that will last us into the next decade."

Shire's ADHD story occupied much of the company's presentation of its fourth-quarter and 2005 financial results, which exceeded analysts' expectations. Excluding one-time items, fourth-quarter earnings per share of 57 cents on revenue of $465 million beat the Wall Street consensus of 54 cents and $429.3 million, according to Thomson First Call.

For the year, Shire's profit of $2.01 and revenue of $1.6 billion beat the average EPS estimate of $1.95 and sales target of $1.58 billion.

On a GAAP basis for the fourth quarter, Shire earned $76.7 million, or 45 cents a share. For the same period in 2004, the company earned $83.4 million, or 50 cents a share, on revenue of $373.7 million.

Shire's stock was up $1.63, or 3.5%, to $47.89 in afternoon trading.