CAMBRIDGE, Mass., May 17 /PRNewswire-FirstCall/ -- Biopure Corporation
(Nasdaq: BPUR) today announced its financial results for the second fiscal
quarter ended April 30, 2007. For the quarter, the company reported a net
loss of $6.2 million, or $0.08 per common share, compared with a net loss
of $7.1 million, or $0.18 per common share, for the corresponding period in
2006. Class A common shares outstanding on April 30, 2007 and 2006 were
77,955,124 and 41,048,770, respectively.
Revenues
Total revenues for the second quarter of 2007 were $619,000, including
$500,000 from sales of the company's veterinary product Oxyglobin(R) and
$113,000 from past congressional appropriations administered by the U.S.
Army*. The Army payments reimburse Biopure for certain trauma development
expenses for Hemopure(R). Total revenues for the same period in 2006 were
$411,000, including $327,000 from Oxyglobin sales and $81,000 from Army
payments. Reimbursements from the Army vary with the amount of reimbursable
activity by the company. Oxyglobin revenues increased during the second
fiscal quarter of 2007 compared to 2006 due to higher unit sales and a
higher average selling price.
Cost of revenues was $2.8 million for the second quarter of fiscal
2007, compared to $3.3 million for the same period in 2006. Cost of
revenues includes costs of both Oxyglobin and Hemopure. During the second
fiscal quarter of 2006 the company recorded a $721,000 write-down of
inventory for which there is no comparable expense in 2007.
Expenses
Research and development expenses were $1.9 million for the second
quarters of fiscal 2007 and 2006. Salary expenses and spending on
preclinical studies increased during the second quarter of fiscal 2007
compared to the same period in 2006, offset by decreases in outside
services expenses.
Sales and marketing expenses increased to $366,000 for the second
quarter of fiscal 2007, from $155,000 for the same period in 2006. The
increase is due to expenses related to a U.K. medical advisory board
meeting for Hemopure.
General and administrative expenses were $2.0 million for the second
quarter of fiscal 2007 compared to $2.3 million for the corresponding
period in 2006, due mostly to lower insurance premiums and consulting
expenses.
Financial Condition
At April 30, 2007, Biopure had $11.5 million in cash on hand.
Clinical Developments
Hemopure-related clinical activities during the second fiscal quarter
included the following:
-- Initiated patient enrollment in a Phase 2 percutaneous coronary
intervention trial in The Netherlands.
-- Continued patient enrollment in the Phase 2 trauma trial in South
Africa, the Phase 2 limb ischemia/wound healing trial in South Africa
and the Phase 2 coronary artery bypass graft surgery (CABG) trial in
Greece and the U.K.; added a CABG trial site in South Africa, which
began screening patients.
-- Met with U.K. regulatory assessors to discuss the company's marketing
authorization application (MAA) for an orthopedic surgical anemia
indication for Hemopure in the U.K., including a modification of the
proposed indication for use when suitable blood is not available, and
continued preparing the next submission to the U.K. Commission on Human
Medicines' responding to the provisional opinion letter. The timing of
the next submission is uncertain but likely to be at the end of the
summer.
-- Worked with consultants and clinicians to develop clinical trial
protocols, including a "compassionate use" protocol for planned
submission to the U.S. Food and Drug Administration (FDA).
-- Participated in a meeting between the Naval Medical Research Center
(NMRC) and the FDA to discuss NMRC's preparation of a modified, Phase 2
RESUS trauma trial protocol and revised investigational new drug (IND)
application for planned submission to the FDA.
-- Ongoing collaboration with NMRC on the development of modified/new
product formulations for trauma, including a potential multi-functional
blood substitute.
FY2007 Third Quarter Financial Results
Biopure expects to issue a press release announcing its financial
results for the third fiscal quarter ending July 31, 2007, on Tuesday,
August 21, 2007.
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 a
potential indication in cardiovascular ischemia, in addition to 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 by the U.S. Food and Drug Administration and
the European Commission, is indicated for the treatment of anemia in dogs.
Biopure has sold approximately 182,000 units of Oxyglobin, which have been
used to treat an estimated 100,000 animals.
Statements in this press release that are not strictly historical are
forward-looking statements, including those that might imply that the
Navy's proposed RESUS clinical trial will be allowed to proceed or may
receive marketing approval in additional jurisdictions or for additional
indications, and those that might imply the timing of regulatory
submissions and regulatory actions. 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, and
the factors identified under the heading "Risk Factors" in the company's
quarterly report on Form 10-Q filed on March 19, 2007, 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.
* 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: Todd Wood Herb Lanzet (Investors)
Biopure Corporation H.L. Lanzet Inc.
(617) 234-6576 (212) 888-4570
IR@biopure.com lanzet@aol.com
BIOPURE CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
(Unaudited)
Three Months Ended Six Months Ended
April 30 April 30
2007 2006 2007 2006
Total revenues $619 $411 $1,213 $888
Cost of revenues 2,775 3,338 5,937 6,412
Gross loss (2,156) (2,927) (4,724) (5,524)
Operating expenses:
Research and development 1,864 1,866 3,779 3,340
Sales and marketing 366 155 758 327
General and administrative 2,027 2,287 4,258 4,587
Total operating expenses 4,257 4,308 8,795 8,254
Loss from operations (6,413) (7,235) (13,519) (13,778)
Other income, net 193 126 371 229
Net loss $(6,220) $(7,109) $(13,148) $(13,549)
Basic and diluted net loss per
common share $(0.08) $(0.18) $(0.18) $(0.40)
Weighted-average common shares
outstanding 77,810 39,574 71,183 34,194
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)
April 30, October 31,
2007 2006
Assets
Total current assets $15,496 $10,852
Net property and equipment 20,637 22,175
Other assets 777 805
Total assets $36,910 $33,832
Liabilities and stockholders' equity
Total current liabilities $3,189 $4,216
Deferred revenue, net of current portion 1,115 987
Restructuring costs, net of current portion - 46
Other long term liabilities 41 41
Total liabilities 4,345 5,290
Total stockholders' equity 32,565 28,542
Total liabilities and stockholders' equity $36,910 $33,832
SOURCE Biopure Corporation
 back to top
Related links:
http://www.biopure.com
http://www.prnewswire.com/comp/131224.html/
CONTACT:
Todd Wood of Biopure Corporation,
+1-617-234-6576, IR@biopure.com, or Investors, Herb Lanzet of
H.L. Lanzet Inc., +1-212-888-4570, lanzet@aol.com
|
