CAMBRIDGE, Mass., Aug. 23 /PRNewswire-FirstCall/ -- Biopure Corporation
(Nasdaq: BPUR) today announced its financial results for the third fiscal
quarter ended July 31, 2007. For the quarter, the company reported a net
loss of $6.4 million, or $0.08 per common share, compared with a net loss
of $6.6 million, or $0.16 per common share, for the corresponding period in
2006. Class A common shares outstanding on July 31, 2007 and 2006 were
77,960,126 and 41,789,370, respectively.
Revenues
Total revenues for the third quarter of 2007 were $550,000, including
$470,000 from sales of the company's veterinary product Oxyglobin(R) and
$58,000 from sales of Hemopure(R) in South Africa. Total revenues for the
same period in 2006 were $396,000, including $312,000 from Oxyglobin sales
and $1,000 from sales of Hemopure(R). The increase in Hemopure sales
reflects the company's marketing efforts and increasing use of the product.
Oxyglobin revenues increased during the third fiscal quarter of 2007
compared to 2006 due to a higher average selling price for product sold in
the U.S.
Cost of revenues was $3.1 million for the third quarter of fiscal 2007,
compared to $2.9 million for the same period in 2006. Cost of revenues
includes costs of both Oxyglobin and Hemopure. The increase is mainly due
to higher salaries expense and plant costs.
Expenses
Research and development expenses were $1.6 million for the third
quarter of fiscal 2007 compared to $1.8 million during the same period in
2006. Expenses during the third fiscal quarter of 2006 include costs
related to the marketing authorization application the company submitted to
the United Kingdom regulatory authority in 2006, for which there are no
comparable expenses in 2007. Partially offsetting the decline in these
costs was higher salaries expense due to increased headcount.
Sales and marketing expenses increased to $341,000 for the third
quarter of fiscal 2007, from $197,000 for the same period in 2006, due to
strategic planning activities for Hemopure in the U.K. and to increased
personnel in South Africa.
General and administrative expenses were $2.1 million for the third
quarter of fiscal 2007 compared to $2.2 million for the corresponding
period in 2006 due to lower insurance premiums.
Financial Condition
At July 31, 2007, Biopure had $6.3 million in cash on hand.
Recent Developments
Marketing
The increase in Hemopure sales in South Africa, while not financially
significant, reflects company-led marketing and gradually increasing use of
the product. Hemopure has been ordered by members of every private hospital
group in South Africa at a price based on current exchange rates of
approximately $830 per unit. Twenty-two public hospitals stock donated
product, and the South African army is a customer. Most of the sales are to
private hospitals; sales to the government are at a lower price than sales
to private hospitals. Selling activities continue to promote use in surgery
when suitable blood is not readily available, medically is not an option or
is unacceptable and blood avoidance is requested. The South Africa
marketing experience continues to give the company important commercial,
clinical and marketing experience.
Compassionate Use
The company recently submitted a draft clinical study protocol to the
FDA for compassionate use of Hemopure in the United States for the
treatment of life-threatening or potentially life threatening anemia where
red blood cell transfusion is not an option. As mentioned previously in a
letter to shareholders, this is a first step in attempting to formalize the
compassionate use of Hemopure without requiring the filing of an IND for
each new case. To date, the FDA has approved all requests for compassionate
use and granted 20 single-patient INDs to Biopure for the treatment of
individual patients with life-threatening anemia when red blood cell
transfusion was not an option. Thirteen patients have been treated for
acute anemia resulting from blood loss or chemotherapy treatment.
U.S. Navy Program.
Following recommendations by the FDA Blood Products Advisory Committee
(BPAC) meeting held in December 2006, the Navy Medical Research Center
(NMRC) with support from Biopure submitted last month a new RESUS (Restore
Effective Survival in Shock) study protocol for a Phase 2 out-of-hospital
trauma study of Biopure's oxygen therapeutic Hemopure. In a recent letter
to the NMRC, the FDA has kept the revised study protocol for RESUS on
clinical hold. Biopure is still evaluating the letter and anticipates
having further discussions with the NMRC and the FDA in the near future on
this subject.
Ongoing Trials
Based on pre-clinical studies, the company believes that Hemopure can
help improve tissue oxygenation, organ function and/or wound healing by
transporting oxygen through constricted or partially blocked arteries and
improving collateral circulation to oxygen-deprived tissues. A 60-patient
clinical trial in patients undergoing multi-vessel coronary artery bypass
graft (CABG) surgery continues to enroll patients in South Africa, Greece
and the U.K. and has enrolled 33 patients. The objective of this trial is
to assess the safety and feasibility of Hemopure in reducing heart damage,
as measured by cardiac enzyme elevation, and enhancing tissue preservation
during CABG surgery. In the Netherlands an 8 patient phase 2 safety and
feasibility study in patients with multi-vessel coronary artery disease who
are undergoing percutaneous coronary intervention (PCI), also continues to
enroll patients. This trial is testing the hypothesis that Hemopure may
improve oxygenation and heart function during times of coronary artery
blockage.
A revised protocol for the company's HEM-0125 50-patient Phase 2 trauma
trial in South Africa has been approved by the University of the
Witwatersrand Human Research Ethics Committee. The company made the
revisions in an attempt to make enrollment simpler. The revised protocol
may be implemented following receipt of regulatory approval from the South
Africa Medicines Control Council. This study is designed to assess the
safety and tolerability of Hemopure, compared to standard therapy, for the
emergency treatment of unstable trauma patients in hospital. The company
hopes to see acceleration in the rate of patient enrollment with the
revised protocol.
Possible Transaction
As an update to the CEO July 2007 letter to stockholders, the company
recently announced certain terms that have been discussed with Malaysian
governmental entities and individuals on a nonbinding basis for a possible
license joint venture arrangement in Malaysia. Such a transaction might
occur if and after the company receives market authorization for Hemopure
in the U.K. Matters discussed were possible (a) investment in Biopure
common stock, but not more than 20%, and (b) financing for a large-scale
manufacturing facility. Many terms were not addressed and would have to be
considered if a transaction were to occur.
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 186,000 units of Oxyglobin, which have been
used to treat an estimated 100,000 animals.
Statements in this release that are not strictly historical are
forward- looking statements, including those statements regarding the
proposed transaction with the Malaysian Ministry of Science and Technology
and Innovation and the use of proceeds from such transaction, the
submission of a draft study protocol submitted to the FDA for the use of
Hemopure in the U.S. in certain life-threatening situations and the
likelihood of FDA approval of the protocol, the possibility that the Navy's
proposed RESUS clinical trial will be allowed to proceed, our plans to
address the FDA's letter to the NMRC and future discussions with the NMRC,
continued enrollment of our clinical trials, the timing and likelihood of
protocol approval by the South Africa Medicines Control Council or any
statements that might imply that Hemopure may receive marketing approval in
additional 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, 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, 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 June 14, 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 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.
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 Nine Months Ended
July 31 July 31
2007 2006 2007 2006
Total revenues $550 $396 $1,763 $1,284
Cost of revenues 3,089 2,939 9,026 9,351
Gross loss (2,539) (2,543) (7,263) (8,067)
Operating expenses:
Research and
development 1,618 1,772 5,397 5,112
Sales and marketing 341 197 1,099 524
General and
administrative 2,107 2,239 6,365 6,826
Total operating
expenses 4,066 4,208 12,861 12,462
Loss from operations (6,605) (6,751) (20,124) (20,529)
Other income, net 157 127 528 356
Net loss $(6,448) $(6,624) $(19,596) $(20,173)
Basic and diluted net
loss per common
share $(0.08) $(0.16) $(0.27) $(0.55)
Weighted-average
common shares
outstanding 77,956 41,616 73,466 36,695
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)
July 31, 2007 October 31, 2006
Assets
Total current assets $10,377 $10,852
Net property and equipment 19,924 22,175
Other assets 763 805
Total assets $31,064 $33,832
Liabilities and stockholders' equity
Total current liabilities $3,602 $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 4,758 5,290
Total stockholders' equity 26,306 28,542
Total liabilities and stockholders'
equity $31,064 $33,832
SOURCE Biopure Corporation
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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 Herb Lanzet, Investors, of
H.L. Lanzet Inc., +1-212-888-4570, lanzet@aol.com
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