News: Alexion Pharmaceuticals, Inc. has revised its 2011 revenue and non-GAAP earnings per share (EPS) guidance. Alexion has revised its 2011 revenue guidance from the previous range of $745 to $755 million, to the higher range of $760 to $768 million, and has revised its 2011 non-GAAP EPS guidance from the previous range of $1.10-$1.15, to the higher range of $1.15- $1.20. Alexion’s revised 2011 guidance is based on continued strength in the global rollout of Soliris ® (eculizumab) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), which includes sales growth in Alexion’s core territories of the U.S., Western Europe and Japan. Alexion is not revising any other items of 2011 financial guidance.
Alexion announced today that the US Food and Drug Administration has approved Soliris for the treatment of patients with atypical hemolytic uremic syndrome (aHUS). 2011 Revenue and EPS guidance provided prior to today’s revision anticipated this approval, and today’s guidance revision is not based on additional forecasted aHUS sales in 2011. Given the lower prevalence of aHUS than PNH, utilization of Soliris for aHUS is expected to increase more slowly than for PNH in all countries. Further, the large majority of patients in the aHUS registration trials live outside of the United States.
In addition, Alexion announced today that the European Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending that the therapeutic indication for Soliris be extended to include the treatment of patients with aHUS. A decision on final approval for marketing in Europe is now expected in approximately two months and then, if positive, country-by-country reimbursement processes will begin.
