CAMBRIDGE, Mass., May 21 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) today announced its financial results for the second fiscal quarter ended April 30, 2008. For the quarter, the company reported a net loss of $5.0 million, or $0.14 per common share, compared with a net loss of $6.2 million, or $0.40 per common share, for the corresponding period in 2007. Class A common shares outstanding on April 30, 2008 and 2007 were 34,971,087 and 15,591,025, respectively.
Total revenues for the second fiscal quarter of 2008 were $902,000, including $777,000 from sales of the company's veterinary product Oxyglobin(R), $89,000 from sales of Hemopure(R) in South Africa and $36,000 in research and development expense reimbursements from the U.S. government. Total revenues for the same period in fiscal 2007 were $619,000, including $500,000 from Oxyglobin sales, $6,000 from sales of Hemopure and $113,000 from government reimbursement. Payments from the government reimburse Biopure for trauma development expenses for Hemopure and vary with the amount of reimbursable activity for the government.
Hemopure sales increased during the second fiscal quarter of 2008 due to the increasing use of the product in South Africa. Oxyglobin revenues increased during the second fiscal quarter of 2008 compared to the same period in 2007 primarily due to higher unit sales to the company's European distributor. During the second fiscal quarter of 2007, the company accounted for European sales on a consignment basis. Now the European distributor buys product for its inventory upon shipment by the company. In the U.S., a higher average selling price of Oxyglobin during the second fiscal quarter of 2008 offset lower unit sales compared to the same period in fiscal 2007. The company believes the lower unit sales in the current period are a result of two price increases implemented during fiscal 2007 without concerted marketing. As previously announced, on May 13, 2008, Dechra Veterinary Products became the exclusive U.S. distributor for Oxyglobin.
Cost of revenues was $1.8 million for the second fiscal quarter of 2008, compared to $2.8 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 $1.2 million for the second fiscal quarter of 2008 compared to $2.1 million for the same period in 2007. Increased manufacturing during the second fiscal quarter of 2008 compared to the same period in 2007 resulted in lower unabsorbed manufacturing costs charged to cost of revenues. Oxyglobin cost of revenues was $645,000 for the second fiscal quarter of 2008 compared to $643,000 for the same period in 2007.
Research and development expenses were $1.8 million for the second fiscal quarter of 2008 compared to $1.9 million for the same period in 2007. For the fiscal 2008 second quarter a $328,000 reduction in spending on clinical and preclinical trials was partially offset by a $207,000 increase in spending on outside services.
General and administrative expenses were $2.0 million for the second fiscal quarters of 2008 and 2007. Insurance premiums and occupancy costs decreased during the second fiscal quarter of 2008 compared to the same period in 2007, and employee related costs and fees for consultants increased.
At April 30, 2008, Biopure had $5.7 million in cash on hand. In May 2008, the company implemented cost reductions, including a workforce reduction. These measures represent overall anticipated savings of approximately $1.2 million annually.
Scientific Presentation and Publications
NIH/FDA Workshop. The company's strategy to pursue indications for its product Hemopure, when blood is not an option, was reinforced by a National Institutes of Health/Food and Drug Administration (NIH/FDA) recent workshop. The workshop, entitled "The Safety of Hemoglobin-based Oxygen Carriers," took place on April 29 and 30, 2008 in Bethesda, Maryland. The company presentation included a platform for moving forward with Hemopure and is posted at http://www.biopure.com. The workshop transcript is expected to be available on the FDA website by late May 2008.
Symposium: University of Maryland. The University of Maryland hosted a symposium on April 28th on "Compassionate Use of Hemoglobin Based Oxygen Carriers (HBOCs) When Blood is Neither an Option Nor Available." Dr. Colin MacKenzie of the University of Maryland chaired the symposium prior to the NIH/FDA workshop. Clinicians discussed their experience with the clinical use of Hemopure in South Africa and in compassionate use patients, approved for treatment on a case by case basis by the FDA. The video of the symposium is available at the University of Maryland website at http://hfrp.umm.edu/cucases.
Two papers presenting data from Biopure trials were accepted for publication recently in peer-reviewed journals.
COR-0002. Preliminary findings from the company's Phase 2 coronary revascularization trial, COR-0002, were published in the EuroIntervention Journal's May 13, 2008 issue. The paper is entitled "Proof-of-concept trial to evaluate haemoglobin based oxygen therapeutics in elective percutaneous coronary revascularization. Rationale, protocol design, and haemodynamic results." The manuscript was authored by principal investigator Patrick W. Serruys, MD, PhD and colleagues of the Department of Interventional Cardiology, Erasmus Medical Centre, Rotterdam, The Netherlands. The paper concluded that this trial represents an important next step in the clinical development program for this product as a treatment for acute myocardial ischaemia. The accompanying technical report co-authored by Biopure Director of Cardiovascular Research, Gregory Dube, PhD., entitled "HBOC-201: The multi-purpose oxygen therapeutic." appeared in this issue also. The report provides an overview of the attributes of Hemopure and how it could be potentially useful in cardiac indications.
HEM-0115. A paper on the company's HEM-0115 trial, a phase 3 trial in patients undergoing orthopedic surgery, is to be published in the spring edition of the Journal of Trauma Injury, Infection and Critical Care. The paper, entitled, "HBOC-201 as an alternative to blood transfusion: efficacy and safety evaluation in a multicenter phase 3 trial in elective orthopedic surgery," was authored by the principal investigators, Drs. Jonathan Jahr and Colin MacKenzie, and others. HEM-0115 included nearly 700 patients. The trial was designed to reduce and/or eliminate perioperative transfusion in patients who were expected to require transfusion of at least two units of packed red blood cells as part of their procedure. Publication is currently scheduled for June 10, 2008.
Dechra Veterinary Products - Exclusive Distributor
Dechra Veterinary Products was appointed as exclusive distributor for Oxyglobin solution [hemoglobin glutamer-200 (bovine)] or HBOC-301, in the U.S. Oxyglobin is the only FDA-approved treatment for canine anemia, a potentially life-threatening condition. Under the terms of the agreement, Dechra will market Oxyglobin in 60 mL single dose and 125 mL single dose infusion bags. Biopure will continue to manufacture Oxyglobin. Dechra Veterinary Products is a division of Dechra Pharmaceuticals PLC, a London Stock Exchange listed company in international animal healthcare marketing.
Biopure expects to meet with the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) in May and in June 2008. The purpose of the meeting is to clarify the issues outlined in a letter Biopure received in April 2008 from the U.K.'s Commission on Human Medicines regarding the company's application for marketing authorization for Hemopure [hemoglobin glutamer-250 (bovine)], or HBOC-201.
Clinical Program Update
The company's ongoing clinical trial in patients undergoing cardiopulmonary bypass surgery is nearing completion with 56 of 60 patients enrolled.
The company continues to support the Naval Medical Research Center's
(NMRC) efforts toward lifting the clinical hold on the Navy's
investigational new drug application to conduct the pending, proposed
clinical trial in trauma patients entitled "Restore Effective Survival in
Shock (RESUS)." In addition to the $22.5M funding allocated by Congress for
the military to pursue research of HBOC-201 through the RESUS program, the
NMRC has received further funding of approximately $3.4 million for the
development of HBOC-201 for a project entitled: A Multifunctional Blood
Substitute for Field Resuscitation of Polytrauma Combat Casualties with
Brain Injury and Concomitant Hemorrhagic Shock. This project is part of the
Post Traumatic Stress Disorder/Traumatic Brain Injury Research Program of
the Office of the Congressionally Directed Medical Research Programs. The
Navy has chosen HBOC-201 as the platform to develop the first multifunction
blood substitute for trauma patients.
Usage of Hemopure in South Africa is continuing to increase.
Biopure Corporation develops, manufactures and markets pharmaceuticals, called oxygen therapeutics, that are intravenously administered to deliver oxygen to the body's tissues. Hemopure [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 [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 in 1998.
Statements in this press 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, that
preclinical study results will be as desired or that the FDA might lift the
clinical hold on the RESUS trial. Actual results 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,
possible delays related to clinical trials, determinations by the FDA, and
unpredictable outcomes of preclinical and 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 March 17, 2008, which can
be accessed in the EDGAR database at the SEC Web site, http://www.sec.gov.
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.
Contact: Tiana Gorham
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
Three Months Ended Six Months Ended
April 30 April 30
2008 2007 2008 2007
Total revenues $902 $619 $1,475 $1,213
Cost of revenues 1,813 2,775 4,601 5,937
Gross loss (911) (2,156) (3,126) (4,724)
Research and development 1,756 1,864 3,243 3,779
Sales and marketing 448 366 728 758
General and administrative 1,947 2,027 3,948 4,258
Total operating expenses 4,151 4,257 7,919 8,795
Loss from operations (5,062) (6,413) (11,045) (13,519)
Other income, net 201 193 377 371
Net loss $(4,861) $(6,220) $(10,668) $(13,148)
Basic and diluted net loss
per common share $(0.14) $(0.40) $(0.31) $(0.92)
shares outstanding 34,971 15,562 34,439 14,237
The net loss per common share for the three and six month periods ended
April 30, 2007 has been adjusted to reflect the one-for-five reverse split
that took effect on October 2, 2007.
CONDENSED CONSOLIDATED BALANCE SHEETS
April 30, 2008 October 31, 2007
Total current assets $10,126 $5,253
Net property and equipment 7,645 8,398
Other assets 552 599
Total assets $18,323 $14,250
Liabilities and stockholders' equity
Total current liabilities $2,943 $3,368
Deferred revenue, net of current portion 1,177 1,177
Other long term liabilities - 41
Total liabilities 4,120 4,586
Total stockholders' equity 14,203 9,664
Total liabilities and stockholders' equity $18,323 $14,250
|SOURCE Biopure Corporation|
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