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SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 10-Q

    |X| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
    For the quarterly period ended                      July 31, 2002
 
    |_| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
    For the transition period from                      to

Commission File Number    001-15167

 
BIOPURE CORPORATION

(Exact name of registrant as specified in its charter)
     
Delaware   04-2836871

 
(State of Incorporation)   (IRS Employer Identification Number)
     
11 Hurley Street, Cambridge, Massachusetts   02141

 
(Address of principal executive offices)   (Zip Code)
 
(617) 234-6500

(Registrant’s telephone number)


    Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes |X| No |_|
 
    The number of shares outstanding of each of the issuer’s classes of common stock as of August 31, 2002 was:
         
Class A Common Stock, $.01 par value
    29,205,269  
Class B Common Stock, $1.00 par value
    117.7  




TABLE OF CONTENTS

Part I— Financial Information:
Item 1 — Financial Statements (Unaudited)
Condensed Consolidated Balance Sheets
Condensed Consolidated Statements of Operations
Condensed Consolidated Statements of Cash Flows
Notes to Condensed Consolidated Financial Statements
Independent Accountants’ Review Report
Item 2 — Management’s Discussion and Analysis of Financial Condition and Results of Operations
Part II— Other Information
Item 1. Legal Proceedings .
Item 2. Changes in Securities and Use of Proceeds
Item 6. Exhibits and Reports on Form 8-K
SIGNATURES
EXHIBIT INDEX
Ex-10.1 Employment Agreement w/ T. Moore
Ex-10.2 Stock Option Agreement
Ex-10.3 Employment Agreement w/ C. Rausch
Ex-10.4 Promissory Note
Ex-10.5 Deferred Compensation Agreement
Ex-10.6 Agreement re: Loan
Ex-10.7 Letter Agreement w/ Paul Looney
Ex-15 Acknowledgement of Ernst & Young LLP
Ex-99.1 Risk Factors
Ex-99.2 Section 906 Certification - T. Moore
Ex-99.3 Section 906 Certification - F. Murphy


Table of Contents

BIOPURE CORPORATION

INDEX TO FORM 10-Q

             
        Page
       
Part I— Financial Information:
       
 
Item 1 - Financial Statements (Unaudited)
       
   
Condensed Consolidated Balance Sheets at July 31, 2002 and October 31, 2001
    3  
   
Condensed Consolidated Statements of Operations for the quarters ended July 31, 2002 and July 31, 2001 and for the nine months ended July 31, 2002 and July 31, 2001
    4  
   
Condensed Consolidated Statements of Cash Flows for the nine months ended July 31, 2002 and July 31, 2001
    5  
   
Notes to Condensed Consolidated Financial Statements
    6-8  
   
Independent Accountants’ Review Report
    9  
 
Item 2 - Management’s Discussion and Analysis of Financial Condition and Results of Operations
    10-15  
Part II— Other Information:
       
 
Item 1 - - Legal Proceedings
    16  
 
Item 2 - - Changes in Securities and Use of Proceeds
    16  
 
Item 6 - - Exhibits and Reports on Form 8-K
    16  
Signatures
    17  
Exhibit Index
    18  


    Biopure®, Hemopure® and Oxyglobin® are registered trademarks of Biopure Corporation.

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Table of Contents

FORM 10-Q
PART I
ITEM 1
PAGE 1

BIOPURE CORPORATION

Condensed Consolidated Balance Sheets
(In thousands, except share and per share data)
(Unaudited)

                         
            July 31,   October 31,
            2002   2001
           
 
Assets:
               
Current assets:
               
 
Cash and cash equivalents
  $ 30,182     $ 36,089  
 
Accounts receivable, net
    139       724  
 
Inventories, net
    4,919       4,665  
 
Other current assets
    1,708       771  
 
   
     
 
       
Total current assets
    36,948       42,249  
Property, plant and equipment, net
    38,089       30,162  
Other assets
    11,674       11,776  
 
   
     
 
       
Total assets
  $ 86,711     $ 84,187  
 
   
     
 
Liabilities and stockholders’ equity:
               
Current liabilities:
               
 
Accounts payable
  $ 891     $ 1,348  
 
Accrued expenses
    6,728       4,949  
 
   
     
 
       
Total current liabilities
    7,619       6,297  
Long-term debt
    9,762       5,205  
Deferred compensation
    184       1,792  
 
   
     
 
       
Total long-term liabilities
    9,946       6,997  
Stockholders’ equity:
               
   
Preferred stock, $0.01 par value, 30,000,000 shares authorized, no shares outstanding
           
 
Common stock:
               
     
Class A, $0.01 par value, 100,000,000 shares authorized, 29,205,269 shares outstanding at
               
       
July 31, 2002 and 25,225,083 at October 31, 2001
    292       252  
     
Class B, $1.00 par value, 179 shares authorized, 117.7 shares outstanding
           
 
Capital in excess of par value
    415,395       383,570  
 
Contributed capital
    24,574       24,574  
 
Notes receivable
    (255 )     (1,655 )
 
Accumulated deficit
    (370,860 )     (335,848 )
 
   
     
 
Total stockholders’ equity
    69,146       70,893  
 
   
     
 
       
Total liabilities and stockholders’ equity
  $ 86,711     $ 84,187  
 
   
     
 

     Note: The balance sheet at October 31, 2001 has been derived from the audited financial statements at that date, but does not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.

See accompanying notes.

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Table of Contents

FORM 10-Q
PART I
ITEM 1
PAGE 2

BIOPURE CORPORATION

Condensed Consolidated Statements of Operations
(In thousands, except share and per share data)
(Unaudited)

                                     
        Three Months Ended   Nine Months Ended
       
 
        July 31,   July 31,   July 31,   July 31,
        2002   2001   2002   2001
       
 
 
 
Revenues:
                               
 
Oxyglobin
  $ 259     $ 945     $ 1,915     $ 2,513  
 
Other
    1       1       1       6  
 
   
     
     
     
 
   
Total revenues
    260       946       1,916       2,519  
Cost of revenues
    2,559       903       4,305       2,587  
 
   
     
     
     
 
Gross profit (loss)
    (2,299 )     43       (2,389 )     (68 )
Operating expenses:
                               
 
Research and development
    7,063       10,297       22,188       27,486  
 
Sales and marketing
    875       784       1,953       2,070  
 
General and administrative
    2,569       1,538       9,303       13,364  
 
   
     
     
     
 
   
Total operating expenses
    10,507       12,619       33,444       42,920  
 
   
     
     
     
 
Loss from operations
    (12,806 )     (12,576 )     (35,833 )     (42,988 )
Other income, net
    210       654       821       2,960  
 
   
     
     
     
 
Net loss
  $ (12,596 )   $ (11,922 )   $ (35,012 )   $ (40,028 )
 
   
     
     
     
 
Per share data:
                               
 
Basic net loss per common share
  $ (0.43 )   $ (0.47 )   $ (1.30 )   $ (1.60 )
 
   
     
     
     
 
 
Weighted-average shares used in computing basic net loss per common share
    29,141       25,134       26,854       25,018  
 
   
     
     
     
 

See accompanying notes.

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Table of Contents

FORM 10-Q
PART I
ITEM 1
PAGE 3

BIOPURE CORPORATION

Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)

                         
            Nine Months Ended
           
            July 31,   July 31,
            2002   2001
           
 
Operating activities:
               
 
Net loss
  $ (35,012 )   $ (40,028 )
   
Adjustments to reconcile net loss to net cash used in operating activities:
               
     
Depreciation and amortization
    3,231       2,955  
     
Equity compensation
    (76 )     6,924  
     
Deferred compensation
    (54 )     (11 )
     
Accrued interest on stockholders’ notes receivable
    (1 )     (71 )
     
Acquired research and development information
          1,511  
     
Changes in assets and liabilities:
               
       
Accounts receivable
    585       (166 )
       
Inventories
    (254 )     (2,029 )
       
Other current assets
    (937 )     61  
       
Accounts payable
    (457 )     (197 )
       
Accrued expenses
    1,779       1,448  
 
   
     
 
       
Net cash used in operating activities
    (31,196 )     (29,603 )
Investing activities:
               
 
Purchases of property, plant and equipment
    (6,340 )     (2,254 )
 
Escrow for new facility
          (10,000 )
 
Long term debt
    (85 )      
 
Other assets
    60       (63 )
 
   
     
 
       
Net cash used in investing activities
    (6,365 )     (12,317 )
Financing activities:
               
 
Net proceeds from sale of common stock
    31,766       (648 )
 
Payment of notes receivable from stockholders
    80       451  
 
Amendment of note receivable from stockholder
    (233 )      
 
Proceeds from exercise of options and warrants
    41       1,689  
 
Proceeds from exercise of non lapse restricted stock
          132  
 
   
     
 
       
Net cash provided by financing activities
    31,654       1,624  
Net decrease in cash and cash equivalents
    (5,907 )     (40,296 )
Cash and cash equivalents at beginning of period
    36,089       88,828  
 
   
     
 
Cash and cash equivalents at end of period
  $ 30,182     $ 48,532  
 
   
     
 
Non-cash transactions:
               
   
Land and license rights acquired upon conversion of stock option
  $ 139     $ 1,005  
 
   
     
 
   
New facility construction financed through capital lease (classified as long-term debt)
  $ 4,642     $ 2,693  
 
   
     
 
   
Settlement of deferred compensation and accrued interest
  $ (1,601 )   $  
 
   
     
 
   
Settlement of note receivable and accrued interest
  $ 1,601     $  
 
   
     
 

See accompanying notes.

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Table of Contents

FORM 10-Q
PART I
ITEM 1
PAGE 4

BIOPURE CORPORATION

Notes to Condensed Consolidated Financial Statements
July 31, 2002

(Unaudited)

1.   Basis of Presentation
 
    The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information and pursuant to the rules and regulations of the Securities and Exchange Commission (SEC). Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.
 
    In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included. Operating results for the three and nine month periods ended July 31, 2002 are not necessarily indicative of the results that may be expected for the year ending October 31, 2002.
 
    The Company has financed operations from inception primarily through sales of equity securities, development and license agreement payments, interest income and debt. The Company has not been profitable since inception and had an accumulated deficit of $370,860,000 as of July 31, 2002. Management expects that the Company will continue to generate losses from operations for the next several years. The Company will explore opportunities to raise capital through sales of securities and potential joint venture or licensing agreements, or leasing arrangements.
 
    At July 31, 2002, the Company had $30,182,000 in cash and cash equivalents. Biopure raised $31,766,000 through the sales of equity in the first nine months of fiscal 2002. Based on the Company’s current operating plan, Biopure requires approximately $13,000,000 for the last three months of fiscal 2002 to support applications to the European regulatory authorities for marketing approval of Hemopure, the ramp up of production of Hemopure and Oxyglobin at the expanded Cambridge manufacturing facility, the additional spending for the South Carolina manufacturing facility discussed below, market development for Hemopure in South Africa and sales of Oxyglobin.
 
    The cash on hand on July 31, 2002 is expected to fund operations into the second quarter of fiscal 2003 or possibly into the third quarter, depending on the amount of Hemopure sales, if any, to South Africa.
 
    Our cash requirements and our forecast of the period of time through which our financial resources would be adequate to support our operations may vary significantly from current projections and actual results may vary.
 
    For further information, refer to the consolidated financial statements and footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended October 31, 2001.
 
2.   Net Loss per Share
 
    Basic net loss per common share is computed based on the weighted-average number of common shares outstanding during the period. Diluted net loss per common share is computed based upon the weighted-average number of common shares outstanding during the year, adjusted for the dilutive effect of shares issuable upon the conversion of convertible stock outstanding and the exercise of common stock options and warrants determined based upon the average market price of common stock for the period. Since the Company has a net loss for all periods presented, the effect of all potentially dilutive securities is antidilutive. Accordingly, basic and diluted net loss per share are the same.

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Table of Contents

FORM 10-Q
PART I
ITEM 1
PAGE 5

BIOPURE CORPORATION
Notes to Condensed Consolidated Financial Statements
July 31, 2002

(Unaudited)
(Continued)

3.   Inventories
 
    Inventories are valued at the lower of cost (determined using the first-in, first-out method) or market. Inventories were as follows:

                 
    July 31,   October 31,
    2002   2001
   
 
In thousands
               
Raw materials
  $ 2,114     $ 771  
Work-in-process
    781       243  
Finished goods-Oxyglobin
    913       1,886  
Finished goods-Hemopure
    1,111       1,765  
 
   
     
 
 
  $ 4,919     $ 4,665  
 
   
     
 

4.   Accrued Expenses
 
    Accrued expenses consisted of the following:

                 
    July 31,   October 31,
    2002   2001
   
 
In thousands
               
Clinical trials
  $ 426     $ 662  
Preparation of biologic license application
    1,089       306  
Capacity upgrade
    195       375  
Accrued payroll and related employee expenses
    1,130       1,365  
Accrued vacation
    562       398  
Accrued legal expenses
    435       257  
South Carolina facility engineering & design
    684        
Insurance premiums
    932        
Other
    1,275       1,586  
 
   
     
 
 
  $ 6,728     $ 4,949  
 
   
     
 

5.   Commitment
 
    In December 2001, Sumter Realty Group, LLC signed an amended letter of intent for the construction and financing of a new 500,000 unit Hemopure plant in South Carolina. The new plant is expected to cost approximately $120,000,000 and is expected to be financed through a capital lease. As such, the financial statements include property, plant and equipment and offsetting debt. As of July 31, 2002, $11,098,000 has been included in property, plant and equipment and $9,762,000 in long term debt reflecting expenditures made by Biopure for the engineering and design costs of the facility. Of the $11,098,000, $10,000,000

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