CAMBRIDGE, Mass., Aug. 21 /PRNewswire-FirstCall/ -- Biopure Corporation
(Nasdaq: BPUR) today announced its financial results for the third fiscal
quarter ended July 31, 2008. For the quarter, the company reported a net
loss of $4.6 million, or $0.13 per common share, compared with a net loss
of $6.4 million, or $0.41 per common share, for the corresponding period in
2007. Class A common shares outstanding on July 31, 2008 and 2007 were
37,340,051 and 15,592,025, respectively.
Revenues
Total revenues for the third fiscal quarter of 2008 were $708,000, or
29% higher than revenues of $550,000 for the same period in fiscal 2007.
The increase is attributable to sales and royalties on sales of the
company's veterinary product Oxyglobin totaling $643,000 in revenue versus
$470,000 in Oxyglobin revenues in the third quarter of 2007. The increase
in Oxyglobin revenues results from higher unit sales. As previously
announced, in the third fiscal quarter of 2008 the Company appointed an
exclusive distributor for Oxyglobin in the U.S. This distributor buys
product for its inventory upon shipment by the Company and pays royalties
in negotiated amounts. Previously the Company sold directly to
veterinarians.
Hemopure sales decreased to $46,000 during the third fiscal quarter of
2008 from $58,000 in the third quarter of 2007 and $89,000 in the second
quarter of 2008. The clinical use of the product in South Africa has been
without serious adverse effects caused by Hemopure. However, sales have
declined because of a meta-analysis published in the April 2008 Journal of
the American Medical Association, which reached negative conclusions about
hemoglobin-based oxygen carriers (HBOCs) as a class of products. Some of
the article's authors also corresponded with regulatory authorities
disparaging Hemopure. Notwithstanding the absence in clinical use of the
adverse effects for HBOCs noted by the authors, citing the article, one
South African state recommended against using Hemopure and an insurer
suspended coverage of the product. The Company is in discussions with
health agencies in South Africa and other countries to respond to their
concerns.
Cost of revenues was $2.4 million for the third fiscal quarter of 2008,
compared to $3.1 million for the same period in 2007. 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 $1.6 million for the third fiscal quarter of 2008 compared to
$2.5 million for the same period in 2007. During the third fiscal quarter
of 2008 the Company took measures to reduce its cash burn, including a 58 %
workforce reduction, cutting facilities maintenance costs and curtailment
of manufacturing. Oxyglobin cost of revenues was $747,000 for the third
fiscal quarter of 2008 compared to $636,000 for the same period in 2007 due
mostly to the increase in unit sales mentioned above, partially offset by
the cost reductions.
Expenses
Research and development expenses were $914,000 for the third fiscal
quarter of 2008 compared to $1.6 million for the same period in 2007.
During the third fiscal quarter of 2008 spending on clinical and
preclinical trials decreased by $313,000, consulting and outside services
decreased by $178,000 and salaries decreased by $111,000 compared to the
same period in 2007.
Sales and marketing expenses decreased to $232,000 for the third
quarter of fiscal 2008, from $341,000 for the same period in 2007. During
fiscal 2007 the Company spent $84,000 in market research for the U.K.
General and administrative expenses were $1.8 million for the third
fiscal quarter of 2008 compared to $2.1 million for the same period in
2007. Insurance premiums, travel expenses and audit fees decreased during
the third fiscal quarter of 2008 compared to the same period in 2007.
Compensation expense, including salaries and equity compensation, decreased
during the third fiscal quarter of 2008 compared to the same period in 2007
but were offset by a one-time severance charge of $249,000 related to the
reduction in force.
Financial Condition
At July 31, 2008, Biopure had $1.7 million in cash on hand. During the
third fiscal quarter the Company signed an agreement with purchasers for a
private placement of its common stock and warrants. Under this agreement,
the Company had raised $800,000 as of July 31, 2008, raised $400,000 in
August and expects to raise an additional $1.1 million over the next three
months, subject to certain conditions, including a requirement that the
Company raise additional funds before September 30, 2008.
Recent Developments
Clinical
Both Biopure and the Naval Medical Research Center (NMRC) continue to
be in discussions with the Food and Drug Administration (FDA) for proposed
clinical trials. The trial in discussion between Biopure and the FDA is a
small trial for patients with acute myelogenous leukemia (AML) who refuse
transfusion with blood components and therefore cannot currently undergo
induction chemotherapy, which depletes oxygen-carrying capacity. FDA, as
previously reported, has indicated that this could be a pivotal trial,
which means that Hemopure might seek a registration for this narrow, yet
significant, indication before other applications. The protocol is being
drafted by Biopure scientists and by outside experts in this field.
NMRC continues to be in discussion with the FDA regarding two trials
under consideration, both of which would be for pre-hospital resuscitation
of patients with severe traumatic hemorrhagic shock. Originally, NMRC
sought approval for a study entitled "Restore Effective SUrvival in Shock"
(RESUS) to be conducted in the U.S. with community notification and the
right to opt out rather than individual patient consent. The NMRC has
proposed subsequently a similar protocol for military casualties in the
field called Op RESUS with subjects who would sign an informed consent
prospectively.
The Company postponed the meeting we had planned to request for July
2008 with the Medicines and Healthcare products Regulatory Agency (MHRA) of
the United Kingdom on the Company's pending application for marketing
authorization for Hemopure. The Company decided to apply its limited
resources to the submission of the AML protocol and working with the FDA.
As previously noted, FDA and the MHRA have communicated about Hemopure.
BPAC Meeting
On September 11, 2008, Biopure is scheduled to deliver a brief
presentation on Hemopure and its safety and efficacy at the Blood Products
Advisory Committee meeting at the FDA. The meeting agenda includes a review
of the workshop on hemoglobin based oxygen carriers held at the National
Institutes of Health in Bethesda, Maryland on April 29 and 30, 2008.
Publications
The journal Expert Opinion Biological Therapeutics has published a Drug
Evaluation focused on HBOC-201, authored by Jonathan S. Jahr, M.D., et al,
of the David Geffen School of Medicine at UCLA, Department of Anesthesia.
The article, appearing in the September 2008 issue of the journal, is
entitled, "HBOC-201, hemoglobin glutamer-250 (bovine), Hemopure (Biopure
Corporation)." Dr. Jahr was a principal investigator in Biopure's pivotal
trial in orthopedic surgery patients and co-author of a June 2008 Journal
of Trauma article that presented the data from that trial. The Expert
Opinion article concludes that; "While HBOC-201 may not replace allogenic
blood transfusions, it may serve to allow critically ill patients to be
resuscitated in the field or hospital setting until either regeneration of
red cell occurs or a transfusion is available." Additionally, the article
states that other indications for HBOC-201 might be explored. The method
used by the authors is a literature review using PubMed listed publications
and official product websites.
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. The Company is
developing Hemopure for other indications and is 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 for
marketing by both the U.S. Food and Drug Administration and the European
Commission, is indicated for the treatment of anemia in dogs. Biopure has
sold approximately 200,000 units of Oxyglobin since its launch.
Statements in this release that are not strictly historical are
forward-looking statements, including any statements implying that any
clinical trial will be initiated and/or carried out to completion or that
study results will be as desired, and any statements that might imply that
Hemopure may receive marketing approval in any jurisdictions other than
South Africa or for a trauma indication anywhere. 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,
including its limited cash resources and need to raise additional capital
to pursue its business, the company's ability to satisfactorily address the
issues raised in the MHRA correspondence or additional issues raised at a
later date, 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, delays in clinical
trials, and the other factors identified under the heading "Risk Factors"
in the Company's quarterly report on Form 10-Q filed on June 16, 2008, as
amended on June 18, 2008, 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.
Contact:
Tiana Gorham
Biopure Corporation
(617) 234-6826
IR@biopure.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
2008 2007 2008 2007
Total revenues $708 $550 $2,183 $1,763
Cost of revenues 2,362 3,089 6,963 9,026
Gross loss (1,654) (2,539) (4,780) (7,263)
Operating expenses:
Research and development 914 1,618 4,157 5,397
Sales and marketing 232 341 960 1,099
General and
administrative 1,849 2,107 5,795 6,356
Total operating expenses 2,995 4,066 10,912 12,861
Loss from operations (4,649) (6,605) (15,692) (20,124)
Other income, net 53 157 438 528
Net loss $(4,596) $(6,448) $(15,254) $(19,596)
Basic and diluted net
loss per common share $(0.13) $(0.41) $(0.44) $(1.33)
Weighted-average common
shares outstanding 35,602 15,591 34,829 14,693
The net loss per common share for the three and nine month periods
ended July 31, 2007 has been adjusted to reflect the one-for-five reverse
split that took effect on October 2, 2007.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)
July 31, 2008 October 31, 2007
Assets
Total current assets $5,918 $5,253
Net property and equipment 7,199 8,398
Other assets 610 599
Total assets $13,727 $14,250
Liabilities and stockholders' equity
Total current liabilities $2,176 $3,368
Deferred revenue, net of current portion 1,177 1,177
Other long term liabilities - 41
Total liabilities 3,353 4,586
Total stockholders' equity 10,374 9,664
Total liabilities and stockholders' equity $13,727 $14,250
SOURCE Biopure Corporation
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Related links:
http://www.biopure.com/
http://www.prnewswire.com/comp/131224.html/
CONTACT:
Tiana Gorham of Biopure Corporation,
+1-617-234-6826, IR@biopure.com
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