Oxygen Biotherapeutics Reports First Quarter FY2013 Financial Results
Conference Call and Webcast for Shareholders set for September 21^st
MORRISVILLE, N.C. -- September 19, 2012
Oxygen Biotherapeutics, Inc. (NASDAQ: OXBT), a development stage biomedical
company focused on developing intravenous and topical oxygen-carrier products,
today announced results for the fiscal year (FY) 2013 first quarter ended July
31, 2012. The company also announced that management will host a conference
call regarding these results on Friday, September 21, 2012 at 11:00 AM EDT.
(see conference call access details below)
Company Highlights for the First Quarter
*Completed GLP-validated bioanalytical method for detection of FtBu in
*Completed studies to determine the pharmacokinetics of FtBu following
intravenous delivery of Oxycyte in models.
*Secured long-term clinical supply of GMP-grade Oxycyte^® to be used in
ongoing clinical trials.
*Raised $2.5 million in second installment of Registered Direct Series A
Convertible Preferred Stock financing.
*Signed a research agreement with the U.S. Navy to study using Oxycyte to
treat hemorrhagic shock.
“Due to our commitment to focus on our core programs, over the last five
quarters we steadily moved closer to reaching our most important objectives.
We have advanced the important and required preclinical trial work that will
address the FDA’s concerns about Oxycyte’s safety with the goal of having our
NDA hold lifted. Important methods for the required pharmacokinetics analysis
were completed, and now the PK analysis is underway. Early in the quarter, we
secured our GMP-grade supply of Oxycyte and initiated the steps necessary to
hire a new contract research organization to resume our Phase IIb trials by
the end of this year. As importantly, we lowered our monthly burn rate 38
percent by eliminating non-essential expenses and curtailing spending on
non-core programs,” said President and Chief Financial Officer Michael Jebsen.
“We believe the above mentioned accomplishments are vitally important to the
long-term success of this company. In an effort to build value, our strategy
for fiscal 2013 is to efficiently conduct our trials, advance the
perfluorocarbon therapeutic modality, expand our intellectual property
portfolio, and seek development partners or licensing agreements in our
non-core areas. We plan to continue to identify and eliminate spending on
non-core programs to ensure all of our resources are focused on executing this
strategy and achieving our objectives.”
Oxygen Biotherapeutics reported a net loss of approximately $3.6 million, or
$0.12 per share, for the three months ended July 31, 2012, compared to a net
loss of approximately $2.9 million, or $0.12 per share for the same period in
the prior fiscal year.
Product revenue for the quarter ended July 31, 2012 decreased to $11,458
compared to $59,477 in the same quarter in 2011 primarily due to the reduction
in our internal sales force and termination of existing distribution
agreements in the prior year. During the three months ended July 31, 2011, we
recorded $26,000 in revenue from sales to our distributor that did not recur
in the current period.
Gross profit as a percent of revenue was 48% and 42% for the three months
ended July 31, 2012 and 2011, respectively. The increase for the first quarter
of fiscal year 2013 primarily was due to a greater proportion of total sales
through retail regional sales versus wholesale and distributor channels as
compared to the same period in the prior year.
Government and grant revenue for the three months ended July 31, 2012 was
$266,549 compared to zero for the same period in the prior year. We earn
revenues for the direct costs of labor, travel and supplies as well as pass
through costs of subcontracts with third-party contract research organizations
for preclinical studies through a cost-reimbursement grant sponsored by the
Marketing and sales expenses decreased to approximately $38,605 for the
quarter ended July 31, 2012 compared to $229,333 for the same period in 2011.
This 83% decrease was driven primarily by fewer costs incurred for
compensation and direct advertising. Other savings during this quarter were
due to decreases in travel and marketing sample expenses as a result of our
regional market focus and a reduction in overall headcount compared to the
same quarter in the previous year.
General and Administrative (G&A) expenses decreased by $347,471 for the period
ended July 31, 2012 compared to the comparable period in 2011. For the period
ended July 31, 2012, legal and professional fees decreased by $140,386;
personnel costs decreased by $95,102; others costs such as travel, supplies
and insurance decreased by $23,539; and facilities and depreciation and
amortization costs decreased by $88,444; compared to the same period in the
prior year. These decreases were offset by an increase in legal fees
associated with the Tenor matter and fees associated with the second closing
of the Series A Preferred Stock financial transaction. The decrease in
consulting fees was primarily related to Board of Director recruiting fees in
the prior period, and the decrease in investor relations costs was the result
of terminating existing agreements with Swiss-based public relations firms and
the decision to withdraw our listing from the SIX Swiss Exchange.
Research and development expenses were $637,272 during the period ended July
31, 2012 compared to $651,961 during the same period in 2011. The overall
decrease was due primarily to a reduction in personnel costs, consulting fees,
and facilities costs. However, clinical and preclinical development costs for
the three months ended July 31, 2012 increased $130,000 compared to the same
period in the prior year primarily due to increases of $218,000 and $50,000 in
costs associated with the preclinical studies designed to respond to the
existing clinical hold, and costs associated with our Phase IIb STOP TBI
trials, respectively. These development costs were offset by decreases of
$123,000 and $15,000 in development costs incurred for our products,
Dermacyte^® and Oxycyte^®, respectively. Personnel and consulting fees were
down $71,000 and $79,000 respectively for the three months ended July 31, 2012
compared to same quarter in the prior year.
For the quarter ended July 31, 2012 we recorded restructuring expenses of
$47,476 as a result of our decision to close the Costa Mesa, CA facility. We
expect to record an additional $175,000 in restructuring costs in the second
quarter for the fair-value of severance and benefits related charges,
relocation costs, and remaining lease liabilities.
As of July 31, 2012, the company had cash and cash equivalents totaling
approximately $2.7 million.
Conference Call Dial-In, Webcast Information
Management will host a conference call on Friday, September 21 at 11:00 AM
EDT. To access the live teleconference, dial (866)761-0748 (U.S. and Canada),
or (617) 614-2706 (international), and enter the passcode 89695133. It will
also be available via live webcast in the Investor section on our website
www.oxybiomed.com. A replay of the webcast will be available on the Oxygen
Biotherapeutics website or by phone for a limited time. To access the replay
by phone, call (888) 286-8010 (U.S. and Canada) or (617) 801-6888
(international) for a limited time. The passcode for the replay is 73191252.
OXYGEN BIOTHERAPEUTICS, INC.
(a development stage enterprise)
July 31, 2012 April 30, 2012
Cash and cash equivalents $ 2,691,130 $ 1,879,872
Accounts receivable 23,632 13,385
Government grant receivable 208,873 35,650
Inventory 114,137 83,370
Prepaid expenses 399,374 455,946
Other current assets 217,088 162,809
Total current assets 3,654,234 2,631,032
Property and equipment, net 282,297 293,606
Debt issuance costs, net 246,505 278,659
Intangible assets, net 881,317 872,971
Other assets 65,666 65,666
Total assets $ 5,130,019 $ 4,141,934
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Accounts payable $ 835,100 $ 542,809
Accrued liabilities 1,105,885 1,273,837
Convertible preferred stock 2,036,667 1,247,266
Current portion of notes payable, 21,223 62,958
Total current liabilities 3,998,875 3,126,870
Long-term portion of notes 1,769,443 1,361,110
Total liabilities 5,768,318 4,487,980
Commitments and contingencies; see
Preferred stock, undesignated,
authorized 9,992,500 shares; see - -
Common stock, par value $.0001 per
share; authorized 400,000,000
shares; issued and 3,107 2,942
outstanding 31,066,462 and
Additional paid-in capital 110,573,420 107,279,296
Deficit accumulated during the (111,214,826 ) (107,628,284 )
Total stockholders’ deficit (638,299 ) (346,046 )
Total liabilities and $ 5,130,019 $ 4,141,934
OXYGEN BIOTHERAPEUTICS, INC.
(a development stage enterprise)
STATEMENTS OF OPERATIONS
Period from May
26, Three months ended July 31,
July 31, 2012
(Unaudited) (Unaudited) (Unaudited)
Product revenue $ 481,712 $ 11,458 $ 59,477
Cost of sales 315,379 5,911 34,604
Net product 166,333 5,547 24,873
Government 581,064 266,549 -
Total net 747,397 272,096 24,873
general, and 48,171,857 1,262,790 1,800,989
Research and 22,712,584 637,272 651,961
Restructuring 47,476 47,476 -
impairment of 363,691 - -
Total operating 71,295,608 1,947,538 2,452,950
Net operating 70,548,211 1,675,442 2,428,077
Interest 41,649,466 1,925,903 435,798
extinguishment 250,097 - -
Other expense (1,232,948 ) (14,803 ) 5,433
Net loss $ 111,214,826 $ 3,586,542 $ 2,869,308
Net loss per $ (0.12 ) $ (0.12 )
Weighted average number of common 30,187,202 23,395,565
shares outstanding, basic
Net loss per $ (0.22 ) $ (0.33 )
Weighted average number of common 32,362,093 24,143,997
shares outstanding, diluted
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 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 skin care
cosmetics for the anti-aging market.
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. 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 our filings with the Securities and Exchange Commission,
including in the current Form 10-Q filed on September 19, 2012, and our annual
report on Form 10-K filed on July 24, 2012, as well as other filings with the
SEC. The company disclaims any intent or obligation to update these
forward-looking statements beyond the date of this release. This caution is
made under the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995.
Oxygen Biotherapeutics, Inc.
Ellen Corliss, 919-855-2112
SVP, Investor Relations &
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