FDA delay of Impax's Rytary should have little impact on outlook, says Needham After the FDA extended the PDUFA for Impax's Rytary by three months but didn't request any new clinical trials, Needham expects the move to little impact on the outlook of investors, who had expected the drug to be approved with little difficulty. The firm expects the drug to be approved but believes that peak sales will be below the company's guidance. Needham maintains a Hold rating on the shares.
Impax reports Q4 adjusted EPS 16c, consensus 12c Reports Q4 revenue $131.2M, consensus $125.47M. Reports Q4 Global Pharmaceuticals revenue $117.9M. The increase is due to higher sales of several key generic products as well as the impact of customer credits that were recorded in the prior year period of $19.2 million as a result of customer credits relating to certain pricing activities.