Re-filing Of Afrezza By MannKind Gives Little Insight Into The Drug’s Approvability

Analyst Jon LeCroy of Hapoalim Securities maintains his "sell" rating on MannKind Corp

, while revising his estimates for the company. The target price for MNKD is set to $1. According to Hapoalim Securities, “While MannKind has re-filed Afrezza and received a December PDUFA date, we note that the risks to the program have not changed and are largely out of the Company’s control. The re-filing, a new PDUFA date and the re-initiation of partnership talks were all expected events that give little insight into the approvability and the potential partnership value of Afrezza.” “MannKind is again in partnership discussions with both regional and global players. While less attractive, a regional (potentially Japanese) company would be the most likely partner, in our view. While we don’t expect a partnership until after full approval, a near-term partnership announcement is obviously a possibility. Aside from a partnership, we think, the next potential catalyst is the announcement of an expert FDA panel. We do not think Afrezza will be approved without first facing an expert panel,” the analyst says. Hapoalim Securities has lowered its EPS estimate for 2010 from -$1.44 to -$1.47. Hapoalim Securities has raised its EPS estimates for 2011 and 2012 from -$1.33 to -$1.32 and from -$1.25 to -$1.22, respectively.