A.P. Pharma Announces Fourth Quarter and Full Year 2012 Financial Results and Highlights Recent Corporate Progress
03/01/2013
|
“We achieved several critical objectives in 2012, highlighted by the
resubmission of our New Drug Application for APF530 to
Recent Accomplishments
-
On
September 28, 2012 , the Company announced that it had resubmitted its New Drug Application (NDA) to theU.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 theFDA , with a Prescription Drug User Fee Act (PDUFA) action date ofMarch 27, 2013 . -
On
October 18, 2012 , the Company announced the appointment ofRobert 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 Operations
A.P. Pharma’s net loss for the fourth quarter of 2012 was
Cash and cash equivalents as of
About APF530
About
(financial tables follow)
A.P. Pharma, Inc. | |||||||||||||||||||
Condensed Statements of Operations | |||||||||||||||||||
(in thousands, except per share amounts) | |||||||||||||||||||
(Unaudited) | |||||||||||||||||||
Three Months Ended | Twelve Months Ended | ||||||||||||||||||
December 31, | December 31, | ||||||||||||||||||
2012 | 2011 | 2012 | 2011 | ||||||||||||||||
Contract revenue | $ | - | $ | - | $ | - | $ | 646 | |||||||||||
Operating expenses: | |||||||||||||||||||
Research and development | 5,023 | 2,855 | 15,045 | 8,207 | |||||||||||||||
General and administrative | 3,605 | 1,263 | 8,786 | 3,501 | |||||||||||||||
Total operating expenses | 8,628 | 4,118 | 23,831 | 11,708 | |||||||||||||||
Operating loss | (8,628 | ) | (4,118 | ) | (23,831 | ) | (11,062 | ) | |||||||||||
Interest expense, net | (197 | ) | (47 | ) | (599 | ) | (373 | ) | |||||||||||
Loss from continuing operations | (8,825 | ) | (4,165 | ) | (24,430 | ) | (11,435 | ) | |||||||||||
Income (loss) from discontinued operations | 1,088 | (96 | ) | 1,082 | (379 | ) | |||||||||||||
Net loss | $ | (7,737 | ) | $ | (4,261 | ) | $ | (23,348 | ) | $ | (11,814 | ) | |||||||
Basic and diluted net loss per share: | |||||||||||||||||||
Loss from continuing operations | $ | (0.03 | ) | $ | (0.02 | ) | $ | (0.10 | ) | $ | (0.10 | ) | |||||||
Net loss | $ | (0.03 | ) | $ | (0.02 | ) | $ | (0.10 | ) | $ | (0.10 | ) | |||||||
Shares used to compute basic and diluted net loss per share |
302,221 | 200,035 | 244,458 | 120,263 | |||||||||||||||
A.P. Pharma, Inc. | |||||||||||
Condensed Balance Sheets | |||||||||||
(in thousands) | |||||||||||
(Unaudited) | |||||||||||
December 31, 2012 | December 31, 2011 | ||||||||||
Assets | |||||||||||
Current assets: | |||||||||||
Cash and cash equivalents | $ | 53,506 | $ | 17,974 | |||||||
Prepaid expenses and other current assets | 584 | 266 | |||||||||
Total current assets | 54,090 | 18,240 | |||||||||
Property and equipment, net | 1,752 | 1,075 | |||||||||
Other long-term assets | 130 | 130 | |||||||||
Total assets | $ | 55,972 | $ | 19,445 | |||||||
Liabilities and Stockholders' Equity | |||||||||||
Current liabilities: | |||||||||||
Accounts payable | $ | 1,912 | $ | 1,010 | |||||||
Accrued expenses | 1,750 | 1,498 | |||||||||
Accrued disposition costs | - | 1,082 | |||||||||
Convertible notes payable to related parties, net of discount | 492 | 103 | |||||||||
Total current liabilities |
4,154 | 3,693 | |||||||||
Stockholders' equity: | |||||||||||
Common stock | 3,024 | 2,002 | |||||||||
Additional paid-in capital | 232,381 | 173,989 | |||||||||
Accumulated deficit | (183,587 | ) | (160,239 | ) | |||||||
Total stockholders' equity | 51,818 | 15,752 | |||||||||
Total liabilities and stockholders' equity | $ | 55,972 | $ | 19,445 | |||||||
Forward-looking Statements
This news release contains "forward-looking statements" as defined by
the Private Securities Litigation Reform Act of 1995. These
forward-looking statements involve risks and uncertainties, including
uncertainties associated with the potential approval of APF530 and the
potential timing for such approval, if approved at all, as well as risks
relating to capital resources and liquidity, satisfactory completion of
clinical studies, progress in research and development programs, launch
and acceptance of new products and other risks and uncertainties
identified in the Company's filings with the
Source:
Investor Relations Contact:
Michael Rice
Office Phone:
646-597-6979
Email: mrice@lifesciadvisors.com
and
Corporate
Contact:
A.P. Pharma, Inc.
John B. Whelan, President and
Chief Executive Officer
Office Phone: 650-366-2626