Alexion beats Street, starts asfotase alfa BLA

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) reported 1Q14 earnings on Thursday that beat the consensus EPS and revenue estimates and disclosed that it began submission to FDA of a rolling BLA for asfotase alfa ( ENB-0040) to treat hypophosphatasia (HPP). Asfotase alfa has breakthrough therapy designation from FDA for HPP, an inherited metabolic disease characterized by defective bone mineralization.

Net sales in the quarter were $566.6 million, up 67% from $338.9 million in 1Q13 and beating the Street's $560.2 million estimate. The company's sole product is Orphan drug Soliris eculizumab, which the company markets in almost 50 countries for atypical hemolytic uremic syndrome (aHUS) and paroxysmal nocturnal hemoglobinuria (PNH). Non-GAAP diluted EPS was $1.53, up from $0.65 the prior year and topping the Street's $1.26 estimate. ...