Shire reports in-line 1Q12 results

Shire plc (LSE:SHP; NASDAQ:SHPGY) reported 1Q12 earnings on Thursday in line with the Street's estimates and said its ADHD drug Vyvanse lisdexamfetamine met the primary endpoint in a Phase II trial to treat binge eating disorder. However, the company also said FDA issued a complete response letter for an application seeking approval of its Lexington, Mass., manufacturing facility to produce Gaucher's disease therapy Vpriv velaglucerase alfa. According to Shire, the letter included questions related to specifications of the facility, in-process parameters and assays, which the company expects to resolve within six months. The company added that it will still be able to meet U.S. demand for Vpriv from new and existing patients through its approved Cambridge, Mass., facility. The glucocerebrosidase enzyme replacement therapy recorded $71.7 million in 1Q12 sales, up 22% in constant exchange rates from 1Q11.

Non-GAAP 1Q12 diluted earnings per ADS were $1.48, matching the Street's estimate and up 20% from $1.23 in 1Q11. First quarter revenues rose 21% to $1.2 billion. Sales of Vyvanse rose 29% to $260 million. In a Phase II trial to treat binge eating disorder, once-daily 50 and 70 mg oral Vyvanse each met the primary endpoint. Both doses of the prodrug of amphetamine significantly reduced the number of binge eating days per week from baseline to week 11 vs. placebo (p<0.01 and p<0.001, respectively). The 30 mg dose of Vyvanse missed the endpoint. ...