CAMBRIDGE, Mass., Feb. 21 /PRNewswire-FirstCall/ -- Biopure Corporation
(Nasdaq: BPUR) today announced its financial results for the first fiscal
quarter ended January 31, 2008. For the quarter, the company reported a net
loss of $5.8 million, or $0.17 per common share, compared with a net loss
of $6.9 million, or $0.53 per common share, for the corresponding period in
2007. Class A common shares outstanding on January 31, 2008 and 2007 were
34,971,087 and 15,543,025, respectively.
Revenues
Total revenues for the first fiscal quarter of 2008 were $573,000,
including $419,000 from sales of the Company's veterinary product
Oxyglobin(R), $58,000 from sales of Hemopure(R) in South Africa and $96,000
in research and development expense reimbursements from the U.S.
government. Total revenues for the same period in fiscal 2007 were
$594,000, including $444,000 from Oxyglobin sales, $16,000 from sales of
Hemopure and $134,000 from government reimbursement. Payments from the
government reimburse Biopure for trauma development expenses for Hemopure
and vary with the amount of reimbursable activity for the government.
Oxyglobin revenues decreased during the first fiscal quarter of 2008
compared to 2007 because of a change in the arrangement between the Company
and its European distributor. During the first quarter of fiscal 2007, the
Company accounted for European sales on a consignment basis. Now the
distributor buys product for its inventory upon shipment by the Company.
The distributor did not purchase any inventory during the first fiscal
quarter of 2008. This decrease was nearly offset by higher U.S. sales of
Oxyglobin due to higher average selling prices. Hemopure sales increased
during the first fiscal quarter of 2008 due to the increasing use of the
product in South Africa.
Cost of revenues was $2.8 million for the first fiscal quarter of 2008,
compared to $3.2 million for the same period in 2007. Cost of revenues
includes costs of both Oxyglobin and Hemopure. Hemopure cost of revenues,
consisting primarily of the allocation of unabsorbed fixed manufacturing
costs, was $2.2 million for the first fiscal quarter of 2008, compared to
$2.3 million for the same period in 2007. Oxyglobin cost of revenues was
$569,000 for the first fiscal quarter of 2008, compared to $819,000 for the
same period in 2007. This decrease is largely due to the absence of
inventory purchases by our distributor in Europe and lower unit sales in
the U.S.
Expenses
Research and development expenses were $1.5 million for the first
fiscal quarter of 2008, compared to $1.9 million for the same period in
2007. The decrease was primarily due to a $469,000 reduction in spending on
preclinical trials.
General and administrative expenses decreased to $2.0 million for the
first fiscal quarter of 2008, from $2.2 million for the same period in
2007. This decrease is primarily due to lower consulting and compensation
expenses and lower insurance premiums.
Financial Condition
At January 31, 2008, Biopure had $11.2 million in cash on hand. During
the quarter, Biopure raised approximately $14.9 million in net proceeds
through sales of its common stock and warrants.
Recent Developments
Scientific Publication and Presentation
A manuscript entitled, Hemodynamic Effects, Safety, and Tolerability of
Hemoglobin-Based Oxygen Carrier-201 in Patients Undergoing PCI for CAD, has
been accepted for publication in the first quarterly issue, dated March 20,
2008, of EuroIntervention Journal (EIJ), the official journal of the
European Association of Interventional Cardiology. EIJ is a peer-reviewed
journal of interventional cardiovascular medicine and is the official
publication of EuroPCR and the European Association of Percutaneous
Cardiovascular Interventions (EAPCI).
The accepted manuscript reports on the Company's first pilot ischemia
clinical trial in patients with coronary artery disease undergoing
angioplasty and stenting procedures, or percutaneous coronary intervention
(PCI). This trial was carried out at five hospitals in Germany, Belgium and
The Netherlands.
Dr. Patrick W. Serruys, Professor of Interventional Cardiology at
Erasmus University in Rotterdam, The Netherlands, will present this study
at the Plenary Session of the Europe PCR meeting being held May 13-16, 2008
in Barcelona, Spain.
Clinical Program Update
The Company's second trial in patients undergoing PCI ended in late
2007. A key objective of this study was to observe whether intracoronary
delivery of Hemopure lessens ischemia as measured by standard tests.
Enrollment was stopped after five patients even though the protocol had
allowed for an enrollment of up to ten, because the investigator concluded
that the results from five patients were sufficient to show a trend toward
proving the principle being tested. A second safety trial, in patients
undergoing limb amputation was also ended in late 2007, primarily because
of slow enrollment caused by a protocol design that did not take into
account different clinical practices across institutions and countries.
The Company's ongoing clinical trial in patients undergoing
cardiopulmonary bypass surgery is nearing completion. Fifty-four of an
anticipated 60 patients have been enrolled.
Biopure is continuing to work toward a clinical trial in terminally ill
patients to examine Hemopure's potential, owing to its oxygen-carrying
capacity, to increase perfusion and improve the quality of life in those
patients. A consultant for this proposed palliative care trial has been
retained by Biopure. Margaret Laccetti, PhD, RN, AOCN, Assistant Professor
of Adult Health at Boston College and an oncology clinical nurse
specialist, is working with the Company and outside advisors to design the
protocol. Dr. Laccetti earned her PhD in nursing, focusing on quality of
life in cancer patients. The Company expects this trial to be conducted in
Europe.
Investor Relations Firm Appointed
Biopure has appointed Sharon Merrill Associates, Inc. as its strategic
communications firm to support its investor relations and corporate
communications efforts. Sharon Merrill Associates is based in Boston.
Accounting Firm
Ernst & Young LLP has advised Biopure that they are not standing for
reappointment for the fiscal year 2008 audit.
FDA Workshop
The U.S. FDA has announced a public workshop entitled: Hemoglobin Based
Oxygen Carriers: Current Status and Future Directions, on April 29 and 30,
2008. Biopure has been asked to present at the workshop.
South Africa
Usage of Hemopure in South Africa is continuing to increase.
Biopure Corporation
Biopure Corporation develops, manufactures and markets pharmaceuticals,
called oxygen therapeutics, that are intravenously administered to deliver
oxygen to the body's tissues. Hemopure(R) [hemoglobin glutamer - 250
(bovine)], or HBOC-201, is approved for sale in South Africa for the
treatment of surgical patients who are acutely anemic. Biopure has applied
in the United Kingdom for regulatory approval of a proposed orthopedic
surgical anemia indication. The company is developing Hemopure for other
indications and is supporting the U.S. Navy's government-funded efforts to
develop a potential out-of-hospital trauma indication. Biopure's veterinary
product Oxyglobin(R) [hemoglobin glutamer - 200 bovine)], or HBOC-301, the
only oxygen therapeutic approved for marketing by both the U.S. Food and
Drug Administration and the European Commission, is indicated for the
treatment of anemia in dogs. Biopure has sold approximately 197,000 units
of Oxyglobin since it first began to market the product.
Statements in this release that are not strictly historical are
forward- looking statements, including those statements implying that any
clinical trial will be initiated and/or carried out to completion or that
study results will be as desired, statements regarding future scientific
publications and presentations on behalf of the Company and any statements
that might imply that Hemopure may receive marketing approval in the United
Kingdom or any other jurisdictions or for additional indications. Actual
results and their timing may differ materially from those projected in
these forward- looking statements due to risks and uncertainties. These
risks include, without limitation, uncertainties regarding the Company's
financial position, including its limited cash resources and need to raise
additional capital to pursue its business, unexpected costs and expenses,
delays and adverse determinations by regulatory authorities, unanticipated
problems with the product's commercial use, whether or not product related,
and with product distributors, sales agents or other third parties, delays
in clinical trials, and the other factors identified under the heading
"Risk Factors" in the Company's annual report on Form 10-K filed on January
29, 2008, which can be accessed in the EDGAR database at the U.S.
Securities and Exchange Commission's (SEC) website, http://www.sec.gov. The
company undertakes no obligation to release publicly the results of any
revisions to these forward- looking statements to reflect events or
circumstances arising after the date hereof. A full discussion of the
Company's operations and financial condition can be found in the company's
filings with the SEC.
The content of this press release does not necessarily reflect the
position or the policy of the U.S. Government or the Department of Defense,
and no official endorsement should be inferred.
BIOPURE CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
(Unaudited)
Three Months Ended
January 31
2008 2007
Total revenues $573 $594
Cost of revenues 2,788 3,162
Gross loss (2,215) (2,568)
Operating expenses:
Research and development 1,487 1,915
Sales and marketing 280 392
General and administrative 1,996 2,231
Total operating expenses 3,763 4,538
Loss from operations (5,978) (7,106)
Other income, net 176 178
Net loss $(5,802) $(6,928)
Basic and diluted net loss per
common share $(0.17) $(0.53)
Weighted-average common shares
outstanding 33,918 12,955
The net loss per common share for the three month period ended January 31,
2007 has been adjusted to reflect the one-for-five reverse split that took
effect on October 2, 2007.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)
January 31, 2008 October 31, 2007
Assets
Total current assets $14,443 $5,253
Net property and equipment 8,007 8,398
Other assets 585 599
Total assets $23,035 $14,250
Liabilities and stockholders' equity
Total current liabilities $2,890 $3,368
Deferred revenue, net of current
portion 1,177 1,177
Other long term liabilities 41 41
Total liabilities 4,108 4,586
Total stockholders' equity 18,927 9,664
Total liabilities and stockholders'
equity $23,035 $14,250
Contact:
Tiana Gorham
Biopure Corporation
(617) 234-6826
IR@biopure.com
SOURCE Biopure Corporation
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http://www.biopure.com/
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CONTACT:
Tiana Gorham of Biopure Corporation,
+1-617-234-6826, IR@biopure.com
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