CAMBRIDGE, Mass., Feb. 15 /PRNewswire-FirstCall/ -- Biopure Corporation
(Nasdaq: BPUR) today announced its financial results for the first fiscal
quarter ended January 31, 2007. For the quarter, the company reported a net
loss of $6.9 million, or $0.11 per common share, compared with a net loss
of $6.4 million, or $0.22 per common share, for the corresponding period in
2006. Class A common shares outstanding on January 31, 2007 and 2006 were
77,715,124 and 38,589,170, respectively.
Revenues
Total revenues for the first quarter of 2007 were $594,000, including
$444,000 from sales of the company's veterinary product Oxyglobin(R) and
$134,000 from past congressional appropriations administered by the U.S.
Army.* The Army payments reimburse Biopure for certain trauma development
expenses for Hemopure(R), the company's oxygen therapeutic for human use.
Total revenues for the same period in 2006 were $477,000, including
$341,000 from Oxyglobin sales and $129,000 from Army payments. Oxyglobin
revenues increased in 2007 compared to the first quarter of fiscal 2006 due
to higher unit sales and a higher average selling price.
Cost of revenues was $3.2 million for the first quarter of fiscal 2007,
compared to $3.1 million for the same period in 2006. 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 $2.3 million for the first quarter of fiscal 2007 compared to
$2.4 million for the same period in 2006. Oxyglobin cost of revenues was
$819,000 for the first quarter of fiscal 2007, compared to $698,000 for the
same period in 2006, due to higher unit sales.
Expenses
Research and development expenses were $1.9 million for the first
quarter of fiscal 2007, compared to $1.5 million for the same period in
2006. The increase was primarily due to higher employee-related expenses,
including new hires, and to higher spending on trauma and ischemia-related
preclinical studies, partially offset by lower outside services expenses.
Sales and marketing expenses increased to $392,000 for the first
quarter of fiscal 2007, from $172,000 for the same period in 2006. This
increase is due to a charge for Hemopure units to be donated to public
hospitals in South Africa to encourage product usage and generate treatment
data.
General and administrative expenses decreased to $2.2 million for the
first quarter of fiscal 2007, from $2.3 million for the same period in
2006. This decrease is primarily due to lower insurance premiums partially
offset by higher consulting expenses.
Financial Condition
At January 31, 2007, Biopure had $17.6 million in cash on hand,
including approximately $16.5 million in net proceeds raised during the
quarter through sales of its common stock and warrants.
Settlement of Litigation
On February 14, 2007, Biopure signed an agreement in principle to
settle the securities class action litigation pending in U.S. District
Court, Massachusetts. Under the settlement, all claims against Biopure and
the individual defendants would be dismissed with prejudice. The settlement
would have no financial effect on Biopure or any of the individual
defendants. The settlement is subject to agreeing upon a formal stipulation
of settlement and court approval.
U.S. Clinical Developments
In November 2006, Biopure met with the Food and Drug Administration
(FDA) to discuss the clinical issues and assessments necessary for an
investigational new drug application (IND) to conduct a clinical trial in
patients in cardiogenic shock. Biopure is preparing an IND for possible
submission to the FDA later this year.
In December 2006, the FDA Blood Products Advisory Committee (BPAC) met
to discuss the U.S. Navy's IND for its proposed 1,100-patient "RESUS" Phase
2b/3 clinical trial of Hemopure for out-of-hospital treatment of trauma
patients in hemorrhagic shock, which the FDA has placed on hold. The BPAC
voted 11 to 8 against proceeding with RESUS as proposed, and committee
members suggested modifications to the trial design. The Navy and FDA are
currently in discussions regarding protocol revisions that could allow
RESUS to proceed as a smaller Phase 2 trial, subject to FDA approval.
Since the BPAC meeting, FDA has approved several requests for
"compassionate use" of Hemopure by granting single-patient INDs for the
treatment of individual patients with life-threatening anemia when red
blood cell transfusion was not an option. Prior to these cases, there had
been no compassionate use of the product in the U.S. since 2000.
Foreign Clinical Developments
In January 2007, Biopure received a provisional opinion letter in
response to the company's marketing authorization application (MAA) for an
orthopedic surgical anemia indication for Hemopure in the U.K. Biopure has
reviewed the questions in the letter with its own U.K. medical advisory
board, believes they are addressable, and plans to meet with the regulatory
assessors who evaluated the application before it formally responds to the
letter in mid 2007. The time period for a final decision on the MAA is not
prescribed by law or regulation and can vary, but a time period of four to
six months is typical once an applicant responds to the questions in the
letter.
In ischemia-related applications, Biopure is sponsoring pilot clinical
trials of Hemopure in Europe and South Africa:
- A 60-patient Phase 2 trial in patients undergoing multi-vessel coronary
artery bypass graft (CABG) surgery has enrolled a total of 26 patients
to date in Greece and the U.K., and hospital approval has been granted
to conduct the trial at a site in South Africa.
- A 100-patient Phase 2 trial in patients with peripheral vascular disease
who are undergoing lower limb amputation has enrolled 11 patients to
date in South Africa.
- Initiation of a proposed Phase 2 trial in The Netherlands in patients
with multi-vessel coronary artery disease who are undergoing
percutaneous coronary intervention (PCI) is pending hospital approval of
an amendment to the previously approved protocol. The principal
investigator has advised the company that the results of this trial may
be apparent after fewer than 10 patients.
In South Africa, Biopure is sponsoring a 50-patient single-center Phase
2 safety and tolerability trial of Hemopure, in a hospital setting, for
emergency treatment of unstable trauma patients who have significant blood
loss and low blood pressure. Enrollment has been slow and intermittent,
with 26 patients enrolled to date. Biopure and the principal investigator
are in discussions regarding protocol modifications designed to accelerate
patient enrollment.
FY2007 Second Quarter Financial Results
Biopure expects to issue a press release announcing its financial
results for the second fiscal quarter ending April 30, 2007, on Thursday,
May 17, 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, that
clinical trials of Hemopure will complete enrollment or have expected
outcomes, that Hemopure will receive marketing approval in Europe or the
U.S. or that Biopure will realize significant sales revenues, and including
any statements regarding the expected size of the RESUS clinical trial or
future actions by the Navy, Biopure's ability to satisfactorily address
issues raised by regulatory authorities, the timing for preparing any such
response, the timing for any subsequent regulatory actions, and the
likelihood of receiving marketing authorization. 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 Annual Report on Form 10-K filed on January 29, 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:
Douglas Sayles Herb Lanzet (Investors)
Biopure Corporation H.L. Lanzet Inc.
(617) 234-6826 (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
January 31
2007 2006
Total revenues $594 $477
Cost of revenues 3,162 3,074
Gross loss (2,568) (2,597)
Operating expenses:
Research and development 1,915 1,474
Sales and marketing 392 172
General and administrative 2,231 2,300
Total operating expenses 4,538 3,946
Loss from operations (7,106) (6,543)
Other income, net 178 103
Net loss $(6,928) $(6,440)
Basic and diluted net loss
per common share $(0.11) $(0.22)
Weighted-average common
shares outstanding 64,773 28,989
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)
January 31, October 31,
2007 2006
Assets
Total current assets $20,878 $10,621
Net property and equipment 21,586 22,406
Other assets 791 805
Total assets $43,255 $33,832
Liabilities and stockholders' equity
Total current liabilities $3,800 $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 4,956 5,290
Total stockholders' equity 38,299 28,542
Total liabilities and stockholders' equity $43,255 $33,832
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, or IR@biopure.com, or Herb Lanzet of H.L. Lanzet
Inc., +1-212-888-4570, or lanzet@aol.com, for Biopure Corporation
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