AMAG Pharmaceuticals Inc. (AMAG) reported a fourth-quarter fiscal 2009 net loss of $18.4 million, or $1.07 per share, which was lower than the year-ago loss of $21.8 million, or $1.28. The Zacks Consensus Estimate for the reported quarter was a loss of $1.08.
The lower loss in the quarter was attributable to higher revenues following the approval and subsequent launch of the Feraheme injection. The higher revenue in the quarter more than offset the higher operating costs and expenses in the quarter attributable to increased selling, general and administrative expenses incurred for the commercialization of Feraheme.
Revenue for the reported quarter came in at $13.1 million as opposed to $0.6 million in the year-ago period. Net product revenues of Feraheme stood at $12.8 million in the reported quarter, including $1.3 million of $11.5 million in previously deferred product revenues. Total operating costs and expenses for the fourth quarter of 2009 were $33.3 million as against $23.8 million in the year-ago quarter.
The company further stated that Feraheme has been purchased by more than 1,300 customers to date with more than 60% of them buying the drug on a repeat basis. Management believes that more than 50% of the demand for Feraheme in 2009 came from patients not undergoing dialysis.
As a reminder, the US Food and Drug Administration (FDA) had granted marketing approval to Feraheme injection on June 30, 2009. AMAG officially launched Feraheme in the U.S. on July 13, 2009. It is an intravenous iron replacement therapy to fight anemia in patients with chronic kidney disease (CKD). The drug can be used by patients even if they are undergoing dialysis. In Dec 2009, the company applied for an approval of the product in Canada for treating iron deficiency anemia in CKD patients.
The company intends to apply for European approval of the drug for the same indication by mid-2010. AMAG is currently consulting with commercial partners in the European Union. Recently, 3SBio Inc. (SSRX), AMAG’s partner in China, submitted an application for a registrational trial to the Chinese State Food and Drug Administration for Feraheme injection for intravenous use.
For 2009, AMAG Pharmaceuticals reported a net loss of $93.4 million, or $5.46 per share, as opposed to a loss of $71.6 million, or $4.22 in 2008. Revenue in 2009 was $17.2 million as opposed to $1.9 million in 2008. Total operating costs and expenses for 2009 stood at $115.1 million compared to $81.5 million in 2008. The Zacks Consensus Estimate for 2009 was a loss of $5.48 per share.
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