Full Press Release Details
Heron Therapeutics Announces Fourth Quarter and Full Year 2013 Financial Results and Highlights Recent Corporate Progress
REDWOOD CITY, Calif. March 5, 2014 Heron Therapeutics, Inc. (NASDAQ: HRTX), a specialty pharmaceutical company, today reported fourth
quarter and full year 2013 financial results and highlighted recent corporate progress.
In the last 12 months, we transformed ourselves into Heron
Therapeutics and made important advancements to position Heron for success in 2014, said Barry D. Quart, PharmD, Chief Executive Officer of Heron Therapeutics. In 2013, we brought in a fresh and highly seasoned management team that is
focused on three key initiatives for 2014. Most importantly, we re concentrating on the resubmission of our New Drug Application for our lead product candidate, Sustol , for the treatment of chemotherapy induced nausea and vomiting (CINV).
Second, we initiated a Phase 3 program which, if successful, would allow us to demonstrate the benefit of Sustol in the treatment of delayed onset CINV in patients receiving highly emetogenic chemotherapy agents. This would represent a new medical
and market opportunity, as no 5-HT3 antagonist is currently approved for this indication. And third, we plan to initiate clinical studies later this year for a new investigational product
targeting the relief of post-surgical pain using our proprietary Biochronomer drug delivery technology.
We believe that Heron
Therapeutics is in a strong position coming into 2014 and look forward to providing updates on our continued progress throughout the year, Dr. Quart continued.
Heron Recent Highlights
Results of Operations
Therapeutics net loss for the fourth quarter of 2013 was $14.0 million, or $0.75 per share, compared to a net loss of $7.7 million, or $0.51 per share, for the fourth quarter of 2012. Net loss was higher in the 2013 quarter primarily due to
increased spending related to manufacturing development expenses and higher personnel costs, including stock compensation expense. Net loss for the fiscal year 2013 was $55.3 million, or $3.42 per share, compared with a net loss of $23.3 million, or
$1.91 per share, for 2012.
Cash and cash equivalents as of December 31, 2013 were $72.3 million, compared to $53.5 million at December 31,
2012. As noted above, Heron closed an underwritten public offering of 7.5 million shares of common stock at an offering price of $8.00 per share and received net proceeds of $57.8 million from the offering. Net cash used in operating activities
was $40.8 million for the year ended December 31, 2013.
Heron s lead product candidate, Sustol (formerly known as APF530), is being developed for the prevention of both acute- and delayed-onset
chemotherapy-induced nausea and vomiting (CINV). One of the most debilitating side effects of cancer chemotherapy, CINV is a leading cause of premature discontinuation of treatment. There is only one injectable 5-HT3 antagonist approved for the prevention of delayed-onset CINV in patients receiving moderately emetogenic chemotherapy (MEC); none are approved for delayed-onset CINV in patients receiving highly
emetogenic chemotherapy (HEC). Sustol 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. Currently available intravenous and oral formulations of granisetron are approved only for the prevention of acute-onset CINV. Granisetron was selected for Sustol
because it is widely prescribed by physicians based on a well-established record of safety and efficacy.
About Heron Therapeutics, Inc.
Heron Therapeutics, Inc. (formerly A.P. Pharma, Inc.) is a specialty pharmaceutical company developing products using its proprietary Biochronomer
polymer-based drug delivery platform. This drug delivery platform is designed to improve the therapeutic profile of injectable pharmaceuticals by converting them from products that must be injected once or twice per day to products that need to be
injected only once every one or two weeks. The Company s lead product, Sustol (formerly known as APF530), is being developed for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting.
In addition to Sustol, Heron is also utilizing its proprietary, sustained-release Biochronomer technology to develop other drugs designed to extend the
duration of action of known active ingredients to address important unmet medical needs. In November 2013, the Company announced movement into full development of the first of these new drug programs the Biochronomer extended release of an
established local anesthetic for the treatment of post-surgical pain. In recently completed, post-surgical animal models of pain, the Company s drug candidates demonstrated statistically significant pain relief for five days, representing the
potential to significantly reduce the need for opiates post-surgery and the length of post-surgical hospital stays. Heron expects to move its pain program into human clinical studies in mid-2014.
(financial tables follow)
Heron Therapeutics, Inc.
Condensed Statements of Operations
(in thousands, except per share amounts)
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2013 | 2012 | 2013 | 2012 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 8,620 | $ | 5,152 | $ | 32,780 | $ | 15,174 | ||||||||
| General and administrative | 5,212 | 3,476 | 21,677 | 8,657 | ||||||||||||
| Total operating expenses | 13,832 | 8,628 | 54,457 | 23,831 | ||||||||||||
| Operating loss | (13,832 | ) | (8,628 | ) | (54,457 | ) | (23,831 | ) | ||||||||
| Interest expense, net | (212 | ) | (197 | ) | (826 | ) | (599 | ) | ||||||||
| Loss from continuing operations | (14,044 | ) | (8,825 | ) | (55,283 | ) | (24,430 | ) | ||||||||
| Income from discontinued operations | 1,088 | 1,082 | ||||||||||||||
| Net loss | $ | (14,044 | ) | $ | (7,737 | ) | $ | (55,283 | ) | $ | (23,348 | ) | ||||
| Basic and diluted net loss per share: | ||||||||||||||||
| Loss from continuing operations | $ | (0.75 | ) | $ | (0.58 | ) | $ | (3.42 | ) | $ | (2.00 | ) | ||||
| Net loss | $ | (0.75 | ) | $ | (0.51 | ) | $ | (3.42 | ) | $ | (1.91 | ) | ||||
| Shares used to compute basic and diluted net loss per share | 18,708 | 15,111 | 16,163 | 12,223 |
Heron Therapeutics, Inc.
Condensed Balance Sheets
| December 31, | ||||||||
| 2013 | 2012 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 72,287 | $ | 53,506 | ||||
| Prepaid expenses and other current assets | 638 | 584 | ||||||
| Total current assets | 72,925 | 54,090 | ||||||
| Property and equipment, net | 2,882 | 1,752 | ||||||
| Other long-term assets | 130 | 130 | ||||||
| Total assets | $ | 75,937 | $ | 55,972 | ||||
| Liabilities and Stockholders Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,264 | $ | 1,912 | ||||
| Accrued expenses | 4,703 | 1,750 | ||||||
| Convertible notes payable to related parties, net of discount | 1,025 | 492 | ||||||
| Total current liabilities | 6,992 | 4,154 | ||||||
| Stockholders equity: | ||||||||
| Common stock | 237 | 152 | ||||||
| Additional paid-in capital | 307,578 | 235,253 | ||||||
| Accumulated deficit | (238,870 | ) | (183,587 | ) | ||||
| Total stockholders equity | 68,945 | 51,818 | ||||||
| Total liabilities and stockholders equity | $ | 75,937 | $ | 55,972 |
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 Sustol (formerly APF530) and the potential timing for such approval, if approved at all, as well as risks and benefits relating to listing
on the NASDAQ Capital Market, 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.
Investor Relations Contacts:
Michael Rice, 646-597-6979
Heron Therapeutics, Inc.
Stephen R. Davis, 650-366-2626
Executive Vice President and
Chief Operating Officer