CAMBRIDGE, Mass., May 18 /PRNewswire-FirstCall/ -- Biopure Corporation
(Nasdaq: BPUR) today announced its financial results for the second fiscal
quarter ended April 30, 2006. For the quarter, the company reported a net
loss of $7.1 million, or $0.18 per common share, compared with a net loss
of $6.6 million, or $0.27 per common share, for the corresponding period in
2005. Class A common shares outstanding on April 30, 2006 and 2005 were
41,048,770 and 24,359,558, respectively.
Biopure had $11.4 million in cash on hand at April 30, 2006, including
approximately $2.1 million in net proceeds raised during the quarter
through the exercise of warrants. The company received an additional
$349,000 from warrant exercises after the close of the quarter. Biopure
believes this cash position will fund operations until mid-October 2006
under the current operating plan. The company intends to seek additional
capital through public or private sales of equity securities and, if
appropriate, consider corporate collaborations for sharing development and
commercialization costs.
Revenues
Total revenues for the second quarter of 2006 were $411,000, including
$327,000 from sales of Biopure's veterinary product Oxyglobin(R), $81,000
from past congressional appropriations administered by the U.S. Army* and
$3,000 from sales of Hemopure(R), the company's product for human use, in
South Africa. The Army payments reimburse Biopure for certain trauma
development expenses for Hemopure. Total revenues for the same period in
2005 were $620,000, including $315,000 from Army payments and $305,000 from
Oxyglobin sales. The payments from the Army vary relative to the amount of
reimbursable activity the company incurs.
Biopure recorded its first sale of Hemopure, the first-ever commercial
sale of a hemoglobin-based oxygen therapeutic for human use, in the first
fiscal quarter of 2006. Sales revenues for Hemopure in fiscal 2006 totaled
$7,000 at the end of the second fiscal quarter. As previously disclosed,
the company does not expect significant sales in South Africa due to the
limited size of the market and the lower cost of allogenic red blood cells,
when available, for the treatment of surgical anemia. Therefore, the
company's sales activities are currently focused on increasing usage of
Hemopure when red blood cells are not readily available.
Cost of revenues was $3.3 million for the second quarter of fiscal
2006, compared to $2.9 million for the same period in 2005. 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 $2.6 million for the second quarter of fiscal 2006
compared to $2.2 million for the same period in 2005. The increase in
Hemopure cost of revenues was largely due to a write-down of inventory
based on a delay in the projected start date of the U.S. Navy's proposed
RESUS clinical trial and a reduction in the sales forecast in South Africa.
Compensation expense, including stock-based compensation recorded under
Financial Accounting Standards Board Statement No. 123(R) and other
incentive compensation, also contributed to the increase compared to last
year. Oxyglobin cost of revenues was $717,000 for the second quarter of
fiscal 2006 compared to $698,000 for the same period in 2005.
Expenses
Research and development expenses were $1.9 million for the second
quarter of fiscal 2006, compared to $1.4 million for the corresponding
period in 2005. The increase was primarily due to higher expenses for
salaries, outside regulatory services, the incentive compensation described
above and clinical trials. These increases were partially offset by lower
spending on preclinical animal studies.
Sales and marketing expenses increased to $155,000 for the second
quarter of fiscal 2006, from $114,000 for the same period in 2005. Of the
$41,000 increase, Hemopure-related sales and marketing expenses accounted
for $22,000 and Oxyglobin-related sales and marketing expenses accounted
for $19,000. Hemopure expenses primarily consist of activities in South
Africa. The company expects this expense to continue to increase in 2006 as
sales and marketing activities increase.
General and administrative expenses were $2.3 million for the second
quarter of fiscal 2006, compared to $2.9 million for the corresponding
period in 2005. Of the decrease, $697,000 was due to a one-time, non-cash
expense in 2005 related to restructuring costs associated with vacated
office space, which has been sublet. In addition, expenses for outside
services and for salaries decreased during the second fiscal quarter of
2006.
Other Developments
Biopure is conducting pilot clinical trials of Hemopure in Europe and
South Africa to assess the potential of several ischemia indications:
* In the 60-patient Phase 2 clinical trial of Hemopure in patients
undergoing multi-vessel coronary artery bypass graft (CABG) surgery,
eight patients have been enrolled in Greece to date, the first patient
was enrolled this week in the United Kingdom, and the company intends to
add a trial site in South Africa.
* In the 100-patient Phase 2 trial of Hemopure in patients with peripheral
vascular disease who are undergoing limb amputation below or through
the knee, the first patient was enrolled this week in South Africa and
patient recruitment is expected to begin shortly in the U.K.
* Enrollment in a planned Phase 2 trial in patients with multi-vessel
coronary artery disease who are undergoing percutaneous coronary
intervention (PCI) is pending hospital authorization at the lead trial
site in the Netherlands. The company also intends to conduct this PCI
trial in Belgium.
Further information about Biopure's current clinical trials is
available at http://www.clinicaltrials.gov.
The company is also supporting the Navy's government-funded development
of Hemopure for a potential out-of-hospital trauma indication. In March
2006, the Food and Drug Administration (FDA) notified the Naval Medical
Research Center (NMRC) of its intention to consult an FDA Advisory
Committee to discuss NMRC's proposed "RESUS" clinical trial of Hemopure for
out-of-hospital treatment of hemorrhagic shock resulting from traumatic
injury, which is currently on clinical hold at FDA.
Biopure is not currently pursuing a surgical anemia indication for
Hemopure in the United States. However, the company has conducted
considerable work to address FDA questions arising from the company's prior
biologics license application. This work was performed in support of the
Navy's proposed RESUS trauma trial, the company's planned mid-2006
marketing application in Europe for a proposed surgical anemia indication,
and its planned communications with FDA regarding a potential ischemia
clinical trial in the U.S.
In other developments, A. Gerson Greenburg, M.D., Ph.D., joined Biopure
in May 2006 as vice president of Medical Affairs. Dr. Greenburg is a
board-certified general surgeon and an expert in oxygen therapeutics. He is
a professor emeritus of surgery at Brown University in Providence, R.I.,
and was formerly chief of quality systems and surgeon-in-chief at Miriam
Hospital in Providence.
Also in May, Biopure was issued two new U.S. patents, both titled
"Preserving a Hemoglobin Blood Substitute with a Transparent Overwrap".
In March 2006, Biopure received notification from The Nasdaq Stock
Market that the company had regained compliance with the $1.00 minimum bid
price requirement for continued listing on the Nasdaq National Market,
pursuant to Marketplace Rule 4450(a)(5).
Upcoming Investor Meeting
Biopure will be giving an investor presentation at The Wall Street
Analyst Forum in New York City on Wednesday, June 14, 2006, at 10:30 a.m.
(ET), which will be accessible online via a webcast link on Biopure's
website at http://www.biopure.com.
FY2006 Third Quarter Financial Results
Biopure expects to issue a press release announcing its financial
results for the third fiscal quarter ending July 31, 2006, on Thursday,
August 17, 2006, before the market opens.
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. This product has not
been approved for sale in other countries. Biopure plans to apply in
Europe, in mid 2006, for approval of an acute anemia indication in
orthopedic surgery patients. The company is developing Hemopure for a
potential indication in cardiovascular ischemia, in addition to supporting
the U.S. Naval Medical Research Center's government-funded efforts to
develop a potential out-of-hospital trauma indication. The company's
veterinary product Oxyglobin(R) [hemoglobin glutamer -- 200 (bovine)], or
HBOC-301, the only oxygen therapeutic approved by the U.S. Food and Drug
Administration and the European Commission, is indicated for the treatment
of anemia in dogs. To date, Biopure has sold approximately 173,000 units of
Oxyglobin, which have been used to treat an estimated 90,000 animals.
Statements in this press release that are not strictly historical are
forward-looking statements, including any that might imply that Biopure
will realize significant sales revenues, that the Navy's proposed RESUS
clinical trial will receive authorization to proceed or that Hemopure will
receive marketing approval in Europe or the U.S. 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,
unexpected costs and expenses, delays and 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, and delays in or unpredictable outcomes of clinical
trials. 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 U.S. Securities and Exchange Commission,
including under the heading "Risk Factors" in the Form 10-Q filed on March
13, 2006, which can be accessed in the EDGAR database at the SEC Web site,
http://www.sec.gov.
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 Six Months Ended
April 30 April 30
2006 2005 2006 2005
Total revenues $411 $620 $888 $1,299
Cost of revenues 3,338 2,891 6,412 5,973
Gross loss (2,927) (2,271) (5,524) (4,674)
Operating expenses:
Research and development 1,866 1,391 3,340 2,910
Sales and marketing 155 114 327 230
General and
administrative 2,287 2,867 4,587 6,481
Total operating expenses 4,308 4,372 8,254 9,621
Loss from operations (7,235) (6,643) (13,778) (14,295)
Other income, net 126 79 229 184
Net loss $(7,109) $(6,564) $(13,549) $(14,111)
Basic and diluted net
loss per common share $(0.18) $(0.27) $(0.40) $(0.69)
Weighted-average common
shares outstanding 39,574 24,293 34,194 20,372
Actual common shares outstanding at April 30, 2006 were 41,048,770.
The net loss per common share for the three month and six month periods
ended April 30, 2005, have been adjusted to reflect the one-for-six reverse
split that took effect on May 27, 2005.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)
April 30, 2006 October 31, 2005
Assets
Total current assets $15,626 $15,575
Net property and equipment 24,189 26,000
Other assets 833 860
Total assets $40,648 $42,435
Liabilities and stockholders' equity
Total current liabilities $4,060 $4,052
Deferred revenue, net of current portion 1,079 987
Restructuring costs, net of current portion 133 221
Other long term liabilities 41 41
Total liabilities 5,313 5,301
Total stockholders' equity 35,335 37,134
Total liabilities and stockholders' equity $40,648 $42,435
* From Grant DAMD17-02-1-0697. The U.S. Army Medical Research
Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014, is
the awarding and administering acquisition office.
Contact: Douglas Sayles Herb Lanzet (Investors)
Biopure Corporation H.L. Lanzet Inc.
(617) 234-6826 (212) 888-4570
IR@biopure.com lanzet@aol.com
SOURCE Biopure Corporation
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Related links:
http://www.biopure.com
http://www.prnewswire.com/comp/131224.html /
CONTACT:
Douglas Sayles of Biopure Corporation,
+1-617-234-6826, IR@biopure.com; or Herb Lanzet (Investors) of
H.L. Lanzet Inc. for Biopure Corporation, +1-212-888-4570,
lanzet@aol.com
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