CAMBRIDGE, Mass., Dec. 14 /PRNewswire-FirstCall/ -- Biopure Corporation
(Nasdaq: BPUR) announced today its financial results for the fourth fiscal
quarter and the fiscal year ended October 31, 2006. For the quarter, the
company reported a net loss of $6.3 million, or $0.13 per common share,
compared with a net loss of $8.2 million, or $0.34 per common share, for
the corresponding period in 2005. For the fiscal year, the company reported
a net loss of $26.5 million, or $0.67 per common share, compared with a net
loss of $28.7 million, or $1.28 per common share, for fiscal 2005. Class A
common shares outstanding on October 31, 2006 and 2005 were 49,365,124 and
24,359,170, respectively.
Biopure also announced today the closing of an underwritten public
offering of stock and warrants that raised net proceeds to Biopure of
approximately $16.6 million assuming no exercise of the warrants. Biopure
sold 28,350,000 new shares of its common stock and warrants to acquire an
additional 28,350,000 new shares, including 3,350,000 shares and 3,350,000
warrants granted to the underwriters to cover over-allotments. The price
for one share and one warrant was $0.64, and the exercise price of each
warrant is $0.80. The warrants have a five-year term and are callable by
Biopure after six months provided that the weighted average price of
Biopure's common stock for ten consecutive days is over $1.20. Dawson James
Securities, Inc. acted as the managing underwriter for the public offering.
Biopure intends to use the proceeds from this offering for general
corporate and working capital purposes.
Revenues
Total revenues for the fourth quarter of 2006 were $431,000, including
$288,000 from sales of Biopure's veterinary product Oxyglobin(R), $114,000
from past congressional appropriations administered by the U.S. Army* and
$29,000 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 $328,000, including $205,000 from Oxyglobin sales and $123,000
from Army payments. The payments from the Army vary relative to the amount
of reimbursable activity of the company.
For the fiscal year, total revenues were $1.7 million in 2006,
including $1.3 million from sales of Oxyglobin, $410,000 from the Army and
$37,000 from sales of Hemopure, compared to $2.1 million in 2005, including
$1.2 million from Oxyglobin sales and $947,000 from the Army. The company
began selling Hemopure in South Africa in early fiscal 2006.
Cost of revenues was $2.6 million for the fourth quarter of fiscal
2006, compared to $4.2 million for the same period in 2005. For the fiscal
year, total cost of revenues was $12.0 million in 2006 compared to $13.3
million 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 $2.1 million for the fourth
quarter of fiscal 2006 compared to $3.3 million for the same period in
2005. For the fiscal year, Hemopure cost of revenues decreased $1.2 million
compared to fiscal 2005. The decrease for the fourth fiscal quarter and
fiscal year was largely due to a one-time, non-cash impairment charge of
$1.4 million, in the fourth quarter of fiscal 2005, related to
manufacturing equipment.
Oxyglobin cost of revenues was $534,000 for the fourth quarter of
fiscal 2006 compared to $836,000 for the same period in 2005. The decrease
was due to the equipment write-down mentioned above. Oxyglobin cost of
revenues was $2.7 million in fiscal 2006 compared to $2.8 million in fiscal
2005.
Expenses
Research and development expenses were $1.6 million for the fourth
quarter of fiscal 2006, compared to $1.1 million for the same period in
2005. For the fiscal year, research and development expenses were $6.7
million in 2006 compared to $5.3 million in 2005. The increase for the
fourth quarter was primarily due to added employees and increased
preclinical study expenses. The increase for the fiscal year was due to
higher salary expense as a result of additional employees, expenses related
to the filing of a marketing authorization application in the United
Kingdom in July 2006, and stock-based compensation expense recorded under
Financial Accounting Standards Board Statement No. 123(R), which the
company adopted in fiscal 2006. These increases were partially offset by
lower spending on preclinical studies.
Sales and marketing expenses decreased to $147,000 for the fourth
quarter of fiscal 2006, from $157,000 for the same period in 2005. For the
fiscal year, sales and marketing expenses increased to $671,000 in 2006,
from $530,000 in 2005. This increase was largely due to expenses for a
Hemopure sales agent in South Africa, partially offset by lower salaries
expense. The company did not have a sales agent in South Africa during
2005.
General and administrative expenses were $2.5 million for the fourth
quarter of fiscal 2006, compared to $3.2 million for the same period in
2005. The decrease was primarily due to lower severance expenses, insurance
premiums, outside services and audit and tax-related expenses, partially
offset by increased legal expenses compared to 2005. For the fiscal year,
general and administrative expenses were $9.3 million in 2006 compared to
$12.1 million in 2005. The decrease was due to lower severance expenses,
outside services, insurance premiums and audit and tax-related expenses in
fiscal 2006. In addition, in fiscal 2005 Biopure expensed $824,000,
relating to the settlement agreement with the former registration holder
and distributor for Hemopure in South Africa, and $724,000 for
restructuring costs associated with vacated office space.
Financial Condition
Biopure had $6.6 million in cash on hand at October 31, 2006, including
approximately $4.9 million in net proceeds raised during the quarter
through the private placement of its common stock and warrants. As
described above, on December 13, 2006, the company completed a public
offering of common stock and warrants that raised net proceeds to Biopure
of approximately $16.6 million. The company expects this cash and cash on
hand at October 31, 2006 to fund its operations through August 2007.
Given the need for additional financing during fiscal 2007, Biopure's
management expects that the company's independent registered public
accounting firm, Ernst & Young LLP, will include a going concern
modification in its audit opinion on Biopure's consolidated financial
statements for the fiscal year ended October 31, 2006.
Other Developments
Later today, December 14, 2006, the Food and Drug Administration's
(FDA) Blood Products Advisory Committee (BPAC) will meet in open session to
discuss the Navy's proposed RESUS clinical trial of Hemopure for
out-of-hospital treatment of hemorrhagic shock resulting from traumatic
injury. The Naval Medical Research Center (NMRC) and Biopure are scheduled
to present, and the meeting is scheduled to last until 6:00 p.m. The
meeting notice and background information are available via the FDA
Advisory Committees dockets website at
http://www.fda.gov/ohrms/dockets/ac/acmenu.htm. The company is hopeful that
the BPAC recommendations to FDA will help clarify the critical path for
removing FDA's clinical hold on the proposed RESUS trial.
FY2007 First Quarter Financial Results
Biopure expects to issue a press release announcing its financial
results for the first fiscal quarter ending January 31, 2007, on Thursday,
February 15, 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. 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.
Biopure has sold approximately 180,000 units of Oxyglobin, which have been
used to treat an estimated 98,000 animals.
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.
Statements in this press release that are not strictly historical are
forward-looking statements, including any that might imply that the Navy's
proposed RESUS clinical trial will be allowed to proceed. 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 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
September 11, 2006, which can be accessed in the EDGAR database at the SEC
Web site, http://www.sec.gov.
* 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.
BIOPURE CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
(Unaudited)
Three Months Ended Twelve Months Ended
October 31 October 31
2006 2005 2006 2005
Total revenues $431 $328 $1,715 $2,110
Cost of revenues 2,643 4,168 11,994 13,307
Gross loss (2,212) (3,840) (10,279) (11,197)
Operating expenses:
Research and development 1,550 1,1445 6,662 5,322
Sales and marketing 147 157 671 530
General and
administrative 2,489 3,201 9,315 12,094
Total operating expenses 4,186 4,503 16,648 17,946
Loss from operations (6,398) (8,343) (26,927) (29,143)
Other income, net 117 160 473 472
Net loss $(6,281) $(8,183) $(26,454) $(28,671)
Basic and diluted
net loss per
common share $(0.13) $(0.34) $(0.67) $(1.28)
Weighted-average
common shares
outstanding 47,554 24,359 39,432 22,382
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)
October 31, 2006 October 31, 2005
Assets
Total current assets $10,621 $15,575
Net property and equipment 22,406 26,000
Other assets 805 860
Total assets $33,832 $42,435
Liabilities and stockholders' equity
Total current liabilities $4,216 $4,052
Deferred revenue, net of current portion 987 987
Restructuring costs, net of current portion 46 221
Other long term liabilities 41 41
Total liabilities 5,290 5,301
Total stockholders' equity 28,542 37,134
Total liabilities and stockholders' equity $33,832 $42,435
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 (Investors) Herb Lanzet of
H.L. Lanzet Inc., +1-212-888-4570, lanzet@aol.com
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