Full Press Release Details
A.P. Pharma Announces Fourth Quarter and Full Year 2011 Financial Results and Provides Update on APF530
REDWOOD CITY, Calif. March 26, 2012 A.P. Pharma, Inc. (OTCBB: APPA) today reported fourth quarter and full year 2011 financial results and provided an update on its lead product
candidate, APF530, being developed for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV).
In 2011 we made solid progress on the work necessary to respond to the APF530 Complete Response Letter and to prepare the resubmission of the New
Drug Application for APF530, said John B. Whelan, A.P. Pharma s president and chief executive officer. The $24 million in funds raised last year provided the resources for us to complete a thorough QT study and other work requested
by the FDA, We are targeting the resubmission of the APF530 New Drug Application for mid-2012 and anticipate our current funds will allow us to operate into 2013.
Results of Operations
A.P. Pharma s net loss for the fourth quarter of 2011 was $4.3
million, or $0.02 per share, compared to a net loss of $1.6 million, or $0.04 per share, for the fourth quarter of
| A.P. Pharma Announces Fourth Quarter and Full Year 2011 | ||
| Financial Results and Provides Up date on APF530 |
2010. The net loss was higher in the 2011 fiscal quarter primarily due to increased spending related to the planned NDA resubmission and higher personnel-related costs, including stock
compensation expense.
Net loss for the fiscal year 2011 was $11.8 million, or $0.10 per share, compared with a net loss of $7.3 million, or
$0.19 per share, for 2010. The higher net loss in 2011 was primarily due to a royalty milestone payment of $2.5 million received in 2010 and higher contract revenue in the prior year related to research and development work performed under an
agreement with Merial Limited, which was terminated in May 2011.
Cash and cash equivalents as of December 31, 2011 were $18.0 million,
compared to $2.1 million at December 31, 2010. Net cash used in operating activities was $7.7 million for the year ended December 31, 2011. As previously reported, the Company entered into two financing arrangements during the second
quarter of 2011, which provided total funding of approximately $24.1 million, net of expenses. The Company believes that its current cash resources are sufficient to fund its operations into 2013.
product, APF530, is in development for the prevention of both acute-onset and delayed-onset chemotherapy-induced nausea and vomiting (CINV). APF530 contains the 5-HT3 receptor antagonist, granisetron, formulated in the Company s proprietary
Biochronomer drug delivery system, which allows therapeutic drug levels to be maintained for five days with a single subcutaneous injection. Intravenous and oral formulations containing granisetron are approved for the prevention of
acute-onset CINV, but not delayed-onset CINV. Granisetron was selected because it is widely prescribed by physicians based on a well-established record of safety and efficacy.
A.P. Pharma is a specialty pharmaceutical company developing products
using its proprietary Biochronomer polymer-based drug delivery technology. The Company s primary focus is on its lead product, APF530, for the prevention of CINV. A.P. Pharma received a Complete Response Letter on the APF530 NDA and is
targeting the resubmission of the NDA for mid-2012. The Company has additional research and development programs that utilize its bioerodible, injectable and implantable drug delivery systems. For further information, please visit the Company s
web site at www.appharma.com.
(financial tables follow)
| A.P. Pharma Announces Fourth Quarter and Full Year 2011 | ||
| Financial Results and Provides Up date on APF530 |
Condensed Statements of Operations
(in thousands, except per share amounts)
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
| 2011 | 2010 | 2011 | 2010 | |||||||||||||
| Contract revenue | $ | $ | 179 | $ | 646 | $ | 1,301 | |||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 2,855 | 1,502 | 8,207 | 7,264 | ||||||||||||
| General and administrative | 1,263 | 410 | 3,501 | 3,971 | ||||||||||||
| Total operating expenses | 4,118 | 1,912 | 11,708 | 11,235 | ||||||||||||
| Operating loss | (4,118 | ) | (1,733 | ) | (11,062 | ) | (9,934 | ) | ||||||||
| Other income (expenses): | ||||||||||||||||
| Interest expense, net | (47 | ) | (1 | ) | (373 | ) | (2 | ) | ||||||||
| Other income | 240 | 240 | ||||||||||||||
| Gain on sale of royalty interest | 2,500 | |||||||||||||||
| Total other income (expense) | (47 | ) | 239 | (373 | ) | 2,738 | ||||||||||
| Net loss from continuing operations | (4,165 | ) | (1,494 | ) | (11,435 | ) | (7,196 | ) | ||||||||
| Loss from discontinued operations | (96 | ) | (102 | ) | (379 | ) | (150 | ) | ||||||||
| Net loss | $ | (4,261 | ) | $ | (1,596 | ) | $ | (11,814 | ) | $ | (7,346 | ) | ||||
| Basic and diluted net loss per share: | ||||||||||||||||
| Loss from continuing operations | $ | (0.02 | ) | $ | (0.04 | ) | $ | (0.10 | ) | $ | (0.18 | ) | ||||
| Net loss | $ | (0.02 | ) | $ | (0.04 | ) | $ | (0.10 | ) | $ | (0.19 | ) | ||||
| Shares used to compute basic and diluted net | ||||||||||||||||
| loss per share | 200,035 | 39,813 | 120,263 | 39,671 |
| A.P. Pharma Announces Fourth Quarter and Full Year 2011 | ||
| Financial Results and Provides Up date on APF530 |
Condensed Balance Sheets
| December 31, 2011 | December 31, 2010 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 17,974 | $ | 2,109 | ||||
| Accounts receivable | 110 | |||||||
| Prepaid expenses and other current assets | 266 | 282 | ||||||
| Total current assets | 18,240 | 2,501 | ||||||
| Property and equipment, net | 1,075 | 357 | ||||||
| Other long-term assets | 130 | 53 | ||||||
| Total assets | $ | 19,445 | $ | 2,911 | ||||
| Liabilities and Stockholders Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,010 | $ | 159 | ||||
| Accrued expenses | 1,498 | 461 | ||||||
| Accrued disposition costs | 1,082 | 703 | ||||||
| Convertible notes payable to related parties, net of discount | 103 | |||||||
| Deferred revenue | 237 | |||||||
| Total current liabilities | 3,693 | 1,560 | ||||||
| Deferred revenue | 35 | |||||||
| Total liabilities | 3,693 | 1,595 | ||||||
| Stockholders equity: | ||||||||
| Common stock | 2,002 | 401 | ||||||
| Additional paid-in capital | 173,989 | 149,340 | ||||||
| Accumulated deficit | (160,239 | ) | (148,425 | ) | ||||
| Total stockholders equity | 15,752 | 1,316 | ||||||
| Total liabilities and stockholders equity | $ | 19,445 | $ | 2,911 |
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 capital resources and liquidity, timely development and regulatory approval of product candidates, 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 Securities and Exchange Commission. We caution investors that forward-looking statements reflect our analysis only on their stated date.
We do not intend to update them except as required by law.
| A.P. Pharma Announces Fourth Quarter and Full Year 2011 | ||
| Financial Results and Provides Up date on APF530 |
A.P. Pharma today announced two additional press releases, which can be accessed on the Company s website at www.appharma.com. These releases
Mobile Phone: 917-282-3242
Email: mrice@lifesciadvisors.com
John B. Whelan, President, Chief Executive Officer and Chief Financial
Office Phone: 650-366-2626