Piper Jaffray Comments On Affymax 4Q Earnings

In a report published by Piper Jaffray, Affymax's (NASDAQ: AFFY) NDA is expected in 2Q11.

Piper Jaffray said that Affymax reported 4Q10 EPS of ($0.46), which was a $0.25 greater loss than its estimate of ($0.21). “The loss was primarily driven by lower than projected revenue. We continue to expect a 2Q11 NDA filing for hematide in the dialysis setting, potentially allowing for 1Q12 approval. The company expects to present detailed P3 results at the NKF meeting (April 26-30), which could provide additional support for approval. As a reminder, although Hematide met its P3 primary and safety endpoints of non-inferiority and showed that the frequency of CSE events was balanced between Hematide and Epogen in dialysis, pre-dialysis patients showed a significant increase in CV events in the Hematide arm, which continues to weigh on shares. Our rating is based on conversations with KOLS and the FDA's historical separation of the pre-dialysis and the dialysis indications; we continue to believe that data supports approval in dialysis.”

Affymax closed yesterday at $6.61.