A.P. Pharma, Inc. (OTCBB: APPA.OB), a specialty pharmaceutical company, today reported fourth quarter and full year 2012 financial results and highlighted recent corporate progress.
“We achieved several critical objectives in 2012, highlighted by the resubmission of our New Drug Application for APF530 to FDA in September. Additionally, we have made a number of key appointments to the management team as we prepare for commercialization of APF530,” said John B. Whelan, A.P. Pharma’s President and Chief Executive Officer.
- On September 28, 2012, the Company announced that it had resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for APF530, its lead product candidate for the prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting.
- On October 16, 2012, the Company announced that its NDA for APF530 was accepted for review by the FDA, with a Prescription Drug User Fee Act (PDUFA) action date of March 27, 2013.
- On October 18, 2012, the Company announced the appointment of Robert Rosen as Senior Vice President and Chief Commercial Officer.
- On December 13, 2012, the Company announced the appointment of Mark S. Gelder, M.D. as Senior Vice President and Chief Medical Officer.
Results of OperationsA.P. Pharma’s net loss for the fourth quarter of 2012 was $7.7 million, or $0.03 per share, compared to a net loss of $4.3 million, or $0.02 per share, for the fourth quarter of 2011. Loss from continuing operations was higher in the 2012 quarter primarily due to increased spending related to the NDA resubmission and higher personnel-related expenses, including stock compensation expense. Income from discontinued operations of $1.1 million was due to an accrual reversal as a result of an arbitrator ruling that no amounts were owed to Amcol for a gross profit guaranty. Net loss for the fiscal year 2012 was $23.3 million, or $0.10 per share, compared with a net loss of $11.8 million, or $0.10 per share, for 2011.