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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, 2003

     
o   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 o

The number of shares outstanding of each of the issuer’s classes of common stock as of September 12, 2003 was:

         
Class A Common Stock, $.01 par value
    44,378,466  
Class B Common Stock, $1.00 par value
    117.7  



 


TABLE OF CONTENTS

Condensed Consolidated Balance Sheets
Condensed Consolidated Statements of Operations
Condensed Consolidated Statements of Cash Flows
Notes to Condensed Consolidated Financial Statements
Management’s Discussion and Analysis of
Financial Condition and Results of Operations
July 31, 2003
Quantitative and Qualitative Disclosure About Market Risk
Controls and Procedures
Part II — Other Information
Item 1. Legal Proceedings
Item 5. Other Information
Item 6. Exhibits and Reports on Form 8-K
SIGNATURES
EX-10.1 AGREEMENT CONCERNING SALE CARL W RAUSCH
EX-10.2 LOCK-UP AGREEMENT THOMAS A MOORE
EX-10.2 LOCK AGREEMENT DAVID N JUDESON
EX-10.4 LOCK-UP AGREEMENT CHARLES A SANDERS MD
EX-10.5 LOCK-UP AGREEMENT C EVERETT KOOP MD
EX-31.1 CERTIFICATION OF THOMAS A. MOORE
EX-31.2 CERTIFICATION OF RONALD F. RICHARDS
EX-32.1 SECT. 906 CERTIFICATION (MOORE)
EX-32.2 SECT. 906 CERTIFICATION (RICHARDS)


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, 2003 and October 31, 2002
    3  
   
Condensed Consolidated Statements of Operations for the three and nine months ended July 31, 2003 and July 31, 2002
    4  
   
Condensed Consolidated Statements of Cash Flows for the nine months ended July 31, 2003 and July 31, 2002
    5  
   
Notes to Condensed Consolidated Financial Statements
    6  
 
Item 2 - Management’s Discussion and Analysis of Financial Condition and Results of Operations
    11  
 
Item 3 - Quantitative and Qualitative Disclosure of Market Risk
    18  
 
Item 4 - Controls and Procedures
    19  
Part II — Other Information:
       
 
Item 1 - Legal Proceedings
    20  
 
Item 2 - Changes in Securities and Use of Proceeds
    20  
 
Item 3 - Defaults Upon Senior Securities
    20  
 
Item 4 - Submission of Matters to a Vote of Security Holders
    20  
 
Item 5 - Other Information
    21  
 
Item 6 - - Exhibits and Reports on Form 8-K
  28  
Signatures
    29  

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

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BIOPURE CORPORATION

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

                         
            July 31, 2003   October 31, 2002
           
 
Assets:
               
Current assets:
               
 
Cash and cash equivalents
  $ 29,841     $ 19,710  
 
Accounts receivable, net
    549       89  
 
Inventories, net
    9,173       8,028  
 
Other current assets
    658       709  
 
   
     
 
   
Total current assets
    40,221       28,536  
Property, plant and equipment, net
    36,911       38,769  
Other assets
    10,955       10,972  
 
   
     
 
   
Total assets
  $ 88,087     $ 78,277  
 
   
     
 
Liabilities and stockholders’ equity:
               
Current liabilities:
               
 
Accounts payable
  $ 954     $ 2,163  
 
Accrued expenses
    4,576       4,026  
 
   
     
 
   
Total current liabilities
    5,530       6,189  
Long-term debt
    9,847       9,847  
Deferred compensation
    142       184  
 
   
     
 
   
Total long-term liabilities
    9,989       10,031  
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, 43,053,710 shares outstanding at July 31, 2003 and 30,353,370 at October 31, 2002
    431       304  
     
Class B, $1.00 par value, 179 shares authorized, 117.7 shares outstanding
           
 
Capital in excess of par value
    463,490       419,065  
 
Contributed capital
    24,574       24,574  
 
Notes receivable
    (256 )     (255 )
 
Accumulated deficit
    (415,671 )     (381,631 )
 
   
     
 
Total stockholders’ equity
    72,568       62,057  
 
   
     
 
       
Total liabilities and stockholders’ equity
  $ 88,087     $ 78,277  
 
   
     
 

Note: The balance sheet at October 31, 2002 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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BIOPURE CORPORATION

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

                                     
        Three Months Ended   Nine Months Ended
       
 
        July 31, 2003   July 31, 2002   July 31, 2003   July 31, 2002
       
 
 
 
Revenues:
                               
 
Oxyglobin
  $ 885     $ 260     $ 2,867     $ 1,916  
 
   
     
     
     
 
   
Total revenues
    885       260       2,867       1,916  
Cost of revenues
    4,608       2,570       15,429       4,390  
 
   
     
     
     
 
Gross loss
    (3,723 )     (2,310 )     (12,562 )     (2,474 )
Operating expenses:
                               
 
Research and development
    2,380       7,063       7,462       22,188  
 
Sales and marketing
    1,969       864       4,591       3,938  
 
General and administrative
    3,342       2,569       9,595       7,233  
 
   
     
     
     
 
   
Total operating expenses
    7,691       10,496       21,648       33,359  
 
   
     
     
     
 
Loss from operations
    (11,414 )     (12,806 )     (34,210 )     (35,833 )
Other income, net
    108       210       170       821  
 
   
     
     
     
 
Net loss
  $ (11,306 )   $ (12,596 )   $ (34,040 )   $ (35,012 )
 
   
     
     
     
 
Per share data:
                               
 
Basic and diluted net loss per common share
  $ (0.28 )   $ (0.43 )   $ (0.98 )   $ (1.30 )
 
   
     
     
     
 
 
Weighted-average shares used in computing basic and diluted net loss per common share
    39,887       29,141       34,605       26,854  
 
   
     
     
     
 

See accompanying notes.

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BIOPURE CORPORATION

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

                       
          Nine Months Ended
         
          July 31, 2003   July 31, 2002
         
 
Operating activities:
               
 
Net loss
  $ (34,040 )   $ (35,012 )
 
Adjustments to reconcile net loss to net cash used in operating activities:
               
   
Depreciation and amortization
    3,992       3,231  
   
Equity compensation
    244       (76 )
   
Deferred compensation
    (42 )     (54 )
   
Accrued interest on stockholders’ notes receivable
    (1 )     (1 )
   
Changes in assets and liabilities:
               
     
Accounts receivable
    (460 )     585  
     
Inventories
    (1,145 )     (254 )
     
Other current assets
    51       (937 )
     
Accounts payable
    (1,209 )     (457 )
     
Accrued expenses
    550       1,779  
 
   
     
 
     
Net cash used in operating activities
    (32,060 )     (31,196 )
Investing activities:
               
 
Purchase of property, plant and equipment
    (2,092 )     (6,340 )
 
Long term debt
          (85 )
 
Other assets
    (25 )     60  
 
   
     
 
     
Net cash used in investing activities
    (2,117 )     (6,365 )
Financing activities:
               
 
Net proceeds from sales of common stock
    43,858       31,766  
 
Payment of notes receivable from stockholders
          80  
 
Amendment of note receivable from stockholder
          (233 )
 
Proceeds from exercise of options and warrants
    450       41  
 
   
     
 
     
Net cash provided by financing activities
    44,308       31,654  
Net increase (decrease) in cash and cash equivalents
    10,131       (5,907 )
Cash and cash equivalents at beginning of period
    19,710       36,089  
 
   
     
 
Cash and cash equivalents at end of period
  $ 29,841     $ 30,182  
 
   
     
 
Non-cash transactions:
               
 
New facility construction financed through capital lease (classified as long-term debt)
  $     $ 4,642  
 
   
     
 
 
Land and license rights acquired upon conversion of stock option
  $     $ 139  
 
   
     
 
 
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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BIOPURE CORPORATION

Notes to Condensed Consolidated Financial Statements
July 31, 2003
(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, 2003 are not necessarily indicative of the results that may be expected for the year ending October 31, 2003; however the Company expects to incur a substantial loss for the year ended October 31, 2003.
 
    Reclassifications have been made to the prior period financial statements presented to conform to the current periods’ presentations.
 
    These financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the fiscal year ended October 31, 2002 filed with the SEC on January 29, 2003.
 
    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 $415,671,000 as of July 31, 2003. For us to remain a going concern we will require significant funding. Management expects that the Company will continue to generate losses from operations for the next several years. The Company is exploring opportunities to raise capital through sales of securities and joint venture, leasing or licensing arrangements, but the Company cannot assure that sufficient funds will be available to it on terms that the Company deems acceptable, if they are available at all. At July 31, 2003, the Company had $29,841,000 in cash and cash equivalents. Since July 31, 2003, the Company has raised approximately $6,003,000 in additional funding and received $2,527,000 from the exercise of certain warrants to purchase its Class A Common Stock (See Note 8 Subsequent Events). The Company expects this funding, in addition to the cash and cash equivalents at July 31, 2003, will be sufficient to fund operations until approximately May 2004 under the Company’s current operating plan.
 
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 period, adjusted for the dilutive effect of the Company’s common stock equivalents, including the shares issuable upon the conversion of Class B Common Stock outstanding and the exercise of common stock options and warrants determined based upon the average market price of common stock for the period. Basic and diluted net loss per common share is computed the same for all periods presented as the Company had losses for all periods presented and, consequently, the effect of Class B Common Stock, options and warrants is anti-dilutive. Dilutive weighted average shares outstanding do not include 9,489,138 common-equivalent shares for the three and nine months ended July 31, 2003 and 5,639,901 common-equivalent shares for the three and nine months ended July 31, 2002 as their effect would have been anti-dilutive.
 
3.   Stock Based Compensation
 
    The Company applies Accounting Principles Board Opinion No. 25, “Accounting for Stock Issued to Employees,” and related interpretations, in accounting for its stock-based compensation plans. Accordingly, no compensation expense has been recognized for stock-based compensation plans. The Company has adopted the disclosure-only provisions of Statement of Financial Accounting Standards No. 148, “Accounting for Stock-Based Compensation-Transition and Disclosure, an amendment of FASB Statement No. 123” (SFAS No. 148). Had compensation expense for the Company’s stock option plans been determined based on the fair value at the grant date for awards under these plans, consistent with the methodology prescribed under SFAS No. 148, the Company’s net loss and net loss per share would have approximated the pro forma amounts indicated below:

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BIOPURE CORPORATION

Notes to Condensed Consolidated Financial Statements
July 31, 2003
(Unaudited)
(Continued)

                                 
    Three Months Ended   Nine Months Ended
   
 
    July 31,   July 31,   July 31,   July 31,
In thousands (except per share data)   2003   2002   2003   2002

 
 
 
 
Net loss, as reported
  $ (11,306 )   $ (12,596 )   $ (34,040 )   $ (35,012 )
Deduct: Total stock-based employee compensation expense determined under fair value based method for all awards
    (1,121 )     (2,245 )     (3,296 )     (3,945 )
 
   
     
     
     
 
Pro forma net loss
  $ (12,427 )   $ (14,841 )   $ (37,336 )   $ (38,957 )
 
   
     
     
     
 
Net loss per share:
                               
Basic and diluted — as reported
  $ (0.28 )   $ (0.43 )   $ (0.98 )   $ (1.30 )
 
   
     
     
     
 
Basic and diluted — pro forma
  $ (0.31 )   $ (0.51 )   $ (1.08 )   $ (1.45 )
 
   
     
     
     
 

    The weighted average fair value of each stock option included in the preceding pro forma amounts was estimated using the Black-Scholes option-pricing model and is amortized over the vesting period of the underlying options. The assumptions used to calculate the SFAS No. 148 pro forma disclosure and the weighted average information are as follows:

                                 
    Three Months Ended   Nine Months Ended
   
 
    July 31, 2003   July 31, 2002   July 31, 2003   July 31, 2002
   
 
 
 
Risk-free interest rate     4.70 %     5.07 %     4.68 %     5.19 %
Expected dividend yield                        
Expected lives     7 years       7 years       7 years       7 years  
Expected volatility     80 %     80 %     80 %     68 %

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

                 
In thousands   July 31, 2003   October 31, 2002

 
 
Raw materials
  $ 1,384     $ 2,122  
Work-in-process
    1,322       676  
Finished goods-Oxyglobin
    2,199       1,992  
Finished goods-Hemopure
    4,268       3,238  
 
   
     
 
 
  $ 9,173     $ 8,028  
 
   
     
 

5.   Accrued Expenses
 
    Accrued expenses consisted of the following:

                 
In thousands   July 31, 2003   October 31, 2002

 
 
Accrued payroll and related employee expenses
  $ 759     $ 562  
Accrued vacation
    758       651  
Accrued legal and audit fees
    303       301  
Accrued health and dental premiums
    601       190  
Financing fees
    537        
South Carolina Project
          551  
Other
    1,618       1,771  
 
   
     
 
 
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