Oxygen Biotherapeutics, Inc. (NASDAQ: OXBT), a development stage biomedical company focused on developing oxygen-carrying intravenous and topical products, today announced financial results for the three and nine month periods ending January 31, 2013.
Third Quarter 2013 Financial Snapshot
- Cash and cash equivalents were $0.8 million at January 31, 2013.
- Net product sales from Dermacyte® were $2,900 for the third quarter of 2013 compared to $4,700 for the three months ended January 31, 2012.
- Revenue earned under our U.S. Army research grant increased to $221,051 for the third quarter of 2013 compared to $146,101 for the three months ended January 31, 2012.
- Net loss from operations decreased 16% for the third quarter of 2013 to $1.6 million compared to $1.9 million for the three months ended January 31, 2012.
- Net cash used for operating activities decreased to $700,000 for the third quarter of 2013 compared to $2.3 million for the three months ended January 31, 2012.
“Activities during our most recent quarter related to three primary and time consuming achievements needed to resume our Phase IIb traumatic brain injury studies abroad, to further our preclinical studies designed to elaborate the safety profile of Oxycyte, our leading drug candidate, and capital raising activities that resulted in securing enough cash to finance activities to help us achieve the next major milestones necessary to drive our company forward, ” said Michael Jebsen, Interim Chief Executive Officer, Chief Financial Officer and President.
Oxygen Biotherapeutics reported net revenue of $222,388 and $1,009,356 for the three and nine months ended January 31, 2012, respectively compared to $148,262 and $268,294 for the same periods in the comparable periods in fiscal 2012. This increase is primarily due to government grant revenue earned under the U.S. Army-funded grant awarded to the company in June 2011 to conduct preclinical studies for Oxycyte® perfluorocarbon (PFC) emulsion.
These preclinical studies are designed to address safety concerns expressed by the U.S. Food and Drug Administration (FDA)and to develop a more robust and comprehensive safety profile for Oxycyte. The results will be used to respond to questions posed by the FDA which led to Oxycyte being placed on clinical hold in the United States in 2008. The Company expects to complete this two-year preclinical program in July with results being publicly reported soon thereafter.
Dermacyte cosmetic sales revenue declined as the company moved resources out of this non-core business. The decrease was primarily due to the elimination of our internal sales force and the suspension of our direct marketing and advertising programs. In addition, during the fourth quarter, the Company licensed Dermacyte products to Valor Cosmetics of Lausanne, Switzerland. Valor has exclusive worldwide rights to distribute, market and sell Dermacyte either under the Dermacyte brand or its own brand name and packaging.
Selling, general and administrative expenses were $1,441,500 for the quarter ended January 31, 2013 compared to $1,422,103 for the same period in the prior year. The slight increase for the period was due primarily to the accrual for litigation settlement costs offset by decreases in costs incurred for legal and professional fees, facilities, and other general and administrative expenses.
Research and Development expenses were $369,447 for the quarter ended January 31, 2013 compared to $599,935 for the same period in the prior year. The decrease for the period was due primarily to reductions in costs incurred for personnel, consultants, facilities and other general expenses.
Selling, general and administrative expenses were $3,127,133 for the nine months ended January 31, 2013, compared to $4,883,903 for the same period in the prior year. The decrease for the period was due primarily to the reversal of accrued 409A costs and reductions in the costs incurred for personnel, legal and professional fees, facilities, and other general and administrative expenses; partially offset by the accrual for litigation settlement costs.
Research and Development expenses were $1,611,293 for the nine months ended January 31, 2013, compared to $4,883,903 for the same period in the prior year. The decrease for the period was due primarily to reductions in costs incurred for personnel, consultants, facilities and other general expenses; partially offset by an increase in costs associated with clinical and preclinical development of Oxycyte.
As of January 31, 2013, the Company had cash and cash equivalents totaling $828,811 compared to $1,879,872 at April 30, 2012.
Conference Call
Management will host a conference call and webcast regarding the third quarter financial results for the three and nine months ending January 31, 2013, on Tuesday, March 19, 2013, at 11 a.m. ET. To access the live teleconference dial (866) 277-1184 (U.S. and Canada), or (617) 597-5360 (international.) The participant pass code is 10084976. Also, a live webcast will be available on our web site http://www.oxybiomed.com/investors.htm . A replay of the webcast will be available by phone or on the Oxygen website for a limited time. To access the replay by phone, call (888) 286-8010 (U.S. and Canada) or (617) 801-6888 (international). The pass code for the replay is 10065352.
About Oxygen Biotherapeutics, Inc.
Oxygen Biotherapeutics, Inc. is developing medical and cosmetic products that efficiently deliver oxygen to tissues in the body. The company has developed a proprietary perfluorocarbon (PFC) therapeutic oxygen carrier called Oxycyte® that is currently in clinical and preclinical studies for intravenous delivery for indications such as traumatic brain injury, decompression sickness and stroke. The company is also developing PFC-based oxygen-carrying creams and gels for topical delivery to the skin for dermatologic conditions and potentially wound care. In addition, the company has commercialized its Dermacyte® line of oxygen-rich skin care products for the anti-aging market.
Financial Tables Follow
The accompanying notes found in the company’s Form 10-Q filed with the
SEC
on March 18, 2013 are an integral part of these Financial
Statements.
OXYGEN BIOTHERAPEUTICS, INC. | |||||||||||
(a development stage enterprise) | |||||||||||
BALANCE SHEETS | |||||||||||
(unaudited) | |||||||||||
| January 31, 2013 | April 30, 2012 | ||||||||||
| (Unaudited) | |||||||||||
| ASSETS | |||||||||||
| Current assets | |||||||||||
| Cash and cash equivalents | $ | 828,811 | $ | 1,879,872 | |||||||
| Accounts receivable | 13,642 | 13,385 | |||||||||
| Government grant receivable | 87,185 | 35,650 | |||||||||
| Inventory | 107,938 | 83,370 | |||||||||
| Prepaid expenses | 341,884 | 455,946 | |||||||||
| Other current assets | 272,713 | 162,809 | |||||||||
| Total current assets | 1,652,173 | 2,631,032 | |||||||||
| Property and equipment, net | 226,808 | 293,606 | |||||||||
| Debt issuance costs, net | 182,197 | 278,659 | |||||||||
| Intangible assets, net | 923,397 | 872,971 | |||||||||
| Other assets | 58,262 | 65,666 | |||||||||
| Total assets | $ | 3,042,837 | $ | 4,141,934 | |||||||
| LIABILITIES AND STOCKHOLDERS’ DEFICIT | |||||||||||
| Current liabilities | |||||||||||
| Accounts payable | $ | 807,679 | $ | 542,809 | |||||||
| Accrued liabilities | 1,085,373 | 1,273,837 | |||||||||
| Convertible preferred stock | - | 1,247,266 | |||||||||
| Current portion of notes payable, net | 98,657 | 62,958 | |||||||||
| Total current liabilities | 1,991,709 | 3,126,870 | |||||||||
| Other liabilities | 65,592 | - | |||||||||
| Long-term portion of notes payable, net | 2,586,109 | 1,361,110 | |||||||||
| Total liabilities | 4,643,410 | 4,487,980 | |||||||||
| Commitments and contingencies; see Note 7. | |||||||||||
| Stockholders' deficit | |||||||||||
| Preferred stock, undesignated, authorized 9,992,500 shares; see Note 5. | - | - | |||||||||
Common stock, par value $.0001 per share; authorized 400,000,000 shares; issued and outstanding 33,650,499 and 29,417,718, respectively | 3,365 | 2,942 | |||||||||
| Additional paid-in capital | 113,581,120 | 107,279,296 | |||||||||
| Deficit accumulated during the development stage | (115,185,058 | ) | (107,628,284 | ) | |||||||
| Total stockholders’ deficit | (1,600,573 | ) | (346,046 | ) | |||||||
| Total liabilities and stockholders' deficit | $ | 3,042,837 | $ | 4,141,934 | |||||||
OXYGEN BIOTHERAPEUTICS, INC. | ||||||||||||||||||||||||||
(a development stage enterprise) | ||||||||||||||||||||||||||
STATEMENTS OF OPERATIONS | ||||||||||||||||||||||||||
(unaudited) | ||||||||||||||||||||||||||
Period from May 26, 1967 (Inception) to | Three months ended January 31, | Nine months ended January 31, | ||||||||||||||||||||||||
January 31, 2013 | 2013 | 2012 | 2013 | 2012 | ||||||||||||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | ||||||||||||||||||||||
| Product revenue | $ | 499,153 | $ | 2,871 | $ | 4,673 | $ | 28,899 | $ | 91,565 | ||||||||||||||||
| Cost of sales | 326,046 | 1,534 | 2,512 | 16,578 | 47,616 | |||||||||||||||||||||
| Net product revenue | 173,107 | 1,337 | 2,161 | 12,321 | 43,949 | |||||||||||||||||||||
| Government grant revenue | 1,311,550 | 221,051 | 146,101 | 997,035 | 224,345 | |||||||||||||||||||||
| Total net revenue | 1,484,657 | 222,388 | 148,262 | 1,009,356 | 268,294 | |||||||||||||||||||||
| Operating expenses | ||||||||||||||||||||||||||
| Selling, general, and administrative | 50,036,200 | 1,441,500 | 1,422,103 | 3,127,133 | 4,883,903 | |||||||||||||||||||||
| Research and development | 23,686,605 | 369,447 | 599,935 | 1,611,293 | 1,740,473 | |||||||||||||||||||||
| Restructuring expense | 220,715 | 2,941 | - | 220,715 | - | |||||||||||||||||||||
| Loss on impairment of long-lived assets | 363,691 | - | - | - | - | |||||||||||||||||||||
| Total operating expenses | 74,307,211 | 1,813,888 | 2,022,038 | 4,959,141 | 6,624,376 | |||||||||||||||||||||
| Net operating loss | 72,822,554 | 1,591,500 | 1,873,776 | 3,949,785 | 6,356,082 | |||||||||||||||||||||
| Interest expense | 43,338,767 | 821,777 | 5,341,988 | 3,615,204 | 6,649,554 | |||||||||||||||||||||
| Loss on extinguishment of debt | 250,097 | - | - | - | - | |||||||||||||||||||||
| Other (income) expense | (1,226,360 | ) | (323 | ) | 82,850 | (8,215 | ) | 91,970 | ||||||||||||||||||
| Net loss | $ | 115,185,058 | $ | 2,412,954 | $ | 7,298,614 | $ | 7,556,774 | $ | 13,097,606 | ||||||||||||||||
| Net loss per share, basic | $ | (0.07 | ) | $ | (0.26 | ) | $ | (0.24 | ) | $ | (0.53 | ) | ||||||||||||||
| Weighted average number of common shares outstanding, basic | 33,177,893 | 27,558,532 | 31,828,750 | 24,922,512 | ||||||||||||||||||||||
| Net loss per share, diluted | $ | (0.14 | ) | $ | (0.39 | ) | $ | (0.30 | ) | $ | (0.65 | ) | ||||||||||||||
| Weighted average number of common shares outstanding, diluted | 35,352,784 | 29,731,481 | 34,003,641 | 26,630,311 | ||||||||||||||||||||||
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by the company that involve risks and uncertainties and reflect the company's judgment as of the date of this release. These statements include the expansion of development of the Oxycyte and Dermacyte product lines and the timing of the introduction of those new products. The forward-looking statements are subject to a number of risks and uncertainties including matters beyond the company's control that could lead to delays in new product introductions and customer acceptance of these new products, and other risks and uncertainties as described in Item 1A (Risk Factors) of our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on July 15, 2011 and in our subsequent filings with the SEC. The company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contacts:
Ellen Corliss, 919-855-2112
Senior
Vice President
Corporate Communications
& Investor Relations
