Biopure Announces 2007 Third Quarter Financial Results

Aug 23, 2007, 01:00 ET from Biopure Corporation

    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.
     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.
     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
     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
     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, 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
                              BIOPURE CORPORATION
     (In thousands, except per share data)
                               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)
      common shares
      outstanding            77,956       41,616       73,466       36,695
     (In thousands)
                                              July 31, 2007   October 31, 2006
      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