Full Press Release Details
A.P. Pharma Announces Third Quarter 2011 Financial Results and Recent Corporate Progress
CITY, Calif. November 7, 2011 A.P. Pharma, Inc. (OTCQB: APPA.PK), a specialty pharmaceutical company, today reported financial results for its third quarter ended September 30, 2011 and highlighted its recent corporate
Operational Highlights
Steady progress is being made toward our goal of resubmitting the New Drug Application for APF530 in the first half of 2012, said John Whelan, A.P. Pharma s president and chief executive
officer. We continue to believe that APF530 could improve the lives of many cancer patients suffering from one of the major side effects associated with their treatment, namely chemotherapy-induced nausea and vomiting. APF530 has the potential
to be the first product to address both acute- and delayed-onset nausea and vomiting with a single, subcutaneous injection at the time of chemotherapy administration, providing an important treatment option for patients and physicians.
Results of Operations
Pharma s net loss for the third quarter of 2011 was $4.2 million, or $0.02 per share, compared to a net loss of $1.7 million, or $0.04 per share, for the third quarter of 2010. The net loss was higher in the current fiscal quarter primarily due
to increased spending related to the planned NDA resubmission and higher stock compensation expense. In addition, the prior-year quarter included contract revenue 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 September 30, 2011 were $21.0 million, compared to $2.1
million at December 31, 2010. Net cash used in operating activities was $5.2 million for the nine months ended September 30, 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. All proceeds were received in the second quarter except for $3.7 million, which was received in July 2011. The Company continues to believe that its current cash
resources are sufficient to fund its operations into 2013.
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| a nd Recent Corporate Progress |
A.P. Pharma s lead 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 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.
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 the first half of 2012. The Company has additional clinical and preclinical stage programs in the area of pain management, all of which utilize its
bioerodible, injectable and implantable delivery systems. For further information, please visit the Company s web site at www.appharma.com.
(financial tables follow)
| A.P. Pharma Announces Third Quarter 20 11 Financial Results | Page 3 | |
| a nd Recent Corporate Progress |
Condensed Statements of Operations
(in thousands, except per share
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2011 | 2010 | 2011 | 2010 | |||||||||||||
| Contract revenue | $ | $ | 351 | $ | 646 | $ | 1,122 | |||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 2,929 | 1,541 | 5,352 | 5,762 | ||||||||||||
| General and administrative | 1,160 | 445 | 2,238 | 3,561 | ||||||||||||
| Total operating expenses | 4,089 | 1,986 | 7,590 | 9,323 | ||||||||||||
| Operating loss | (4,089 | ) | (1,635 | ) | (6,944 | ) | (8,201 | ) | ||||||||
| Other income (expenses): | ||||||||||||||||
| Interest expense, net | (62 | ) | (1 | ) | (326 | ) | (2 | ) | ||||||||
| Gain on sale of royalty interest | 2,500 | |||||||||||||||
| Loss from continuing operations | (4,151 | ) | (1,636 | ) | (7,270 | ) | (5,703 | ) | ||||||||
| Loss from discontinued operations | (51 | ) | (36 | ) | (283 | ) | (47 | ) | ||||||||
| Net loss | $ | (4,202 | ) | $ | (1,672 | ) | $ | (7,553 | ) | $ | (5,750 | ) | ||||
| Basic and diluted net loss per share: | ||||||||||||||||
| Loss from continuing operations | $ | (0.02 | ) | $ | (0.04 | ) | $ | (0.08 | ) | $ | (0.14 | ) | ||||
| Net loss | $ | (0.02 | ) | $ | (0.04 | ) | $ | (0.08 | ) | $ | (0.15 | ) | ||||
| Shares used to compute basic and diluted net loss per share | 198,279 | 39,507 | 93,381 | 39,481 |
| A.P. Pharma Announces Third Quarter 20 11 Financial Results | Page 4 | |
| a nd Recent Corporate Progress |
Condensed Balance Sheets
| September 30, 2011 | December 31, 2010 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 21,019 | $ | 2,109 | ||||
| Accounts receivable | 110 | |||||||
| Prepaid expenses and other current assets | 301 | 282 | ||||||
| Total current assets | 21,320 | 2,501 | ||||||
| Property and equipment, net | 346 | 357 | ||||||
| Other long-term assets | 130 | 53 | ||||||
| Total assets | $ | 21,796 | $ | 2,911 | ||||
| Liabilities and Stockholders Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 433 | $ | 159 | ||||
| Accrued expenses | 1,121 | 461 | ||||||
| Accrued disposition costs | 986 | 703 | ||||||
| Deferred revenue | 237 | |||||||
| Total current liabilities | 2,540 | 1,560 | ||||||
| Convertible notes payable, net of discount | 64 | |||||||
| Deferred revenue | 35 | |||||||
| Total liabilities | 2,604 | 1,595 | ||||||
| Stockholders equity: | ||||||||
| Common stock | 2,002 | 401 | ||||||
| Additional paid-in capital | 173,168 | 149,340 | ||||||
| Accumulated deficit | (155,978 | ) | (148,425 | ) | ||||
| Total stockholders equity | 19,192 | 1,316 | ||||||
| Total liabilities and stockholders equity | $ | 21,796 | $ | 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 Third Quarter 20 11 Financial Results | Page 5 | |
| a nd Recent Corporate Progress |
John B. Whelan, President, Chief Executive Officer and Chief Financial Officer
Corporate Communications Alliance, LLC