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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 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 March 29, 2003
     
    OR
     
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: 000-04829

Nabi Biopharmaceuticals

(Exact name of registrant as specified in its charter)

     
Delaware   59-1212264
(State or other jurisdiction of
incorporation or organization)
  (I.R.S. Employer Identification No.)

5800 Park of Commerce Boulevard N.W., Boca Raton, FL 33487
(Address of principal executive offices, including zip code)

(561) 989-5800
(Registrant’s telephone number, including area code)

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 twelve 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. x Yes o No

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act). x Yes o No

The number of shares outstanding of registrant’s common stock, par value $0.10 per share, at April 24, 2003 was 39,101,017 shares.

 


TABLE OF CONTENTS

PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED STATEMENTS OF OPERATIONS
CONSOLIDATED STATEMENTS OF CASH FLOWS
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Item 4. Controls and Procedures
PART II                      OTHER INFORMATION
Item 1. Legal Proceedings
Item 2. Changes in Securities and Use of Proceeds
Item 3. Defaults Upon Senior Securities
Item 4. Submission of Matters to a Vote of Security Holders
Item 5. Other Information
Item 6. Exhibits and Report on Form 8-K
SIGNATURES
CERTIFICATIONS
EX-99.1 CEO & CFO CERTIFICATIONS


Table of Contents

Nabi Biopharmaceuticals

INDEX

                           
                      Page No.
                     
PART I
      FINANCIAL INFORMATION        
 
Item 1
      Financial Statements     3  
 
        Consolidated Balance Sheets, as of March 29, 2003 (unaudited) and        
 
          December 28, 2002     3  
 
        Consolidated Statements of Operations for the Three Months Ended        
 
          March 29, 2003 and March 30, 2002 (unaudited)     4  
 
        Consolidated Statements of Cash Flows for the Three Months Ended        
 
          March 29, 2003 and March 30, 2002 (unaudited)     5  
 
        Notes to Consolidated Financial Statements (unaudited)     6  
 
Item 2
      Management's Discussion and Analysis of Financial Condition        
 
      and Results of Operations     11  
 
Item 3
      Quantitative and Qualitative Disclosures About Market Risk     15  
 
Item 4
      Controls and Procedures     16  
PART II
      OTHER INFORMATION        
 
Item 1
      Legal Proceedings     17  
 
Item 2
      Changes in Securities and Use of Proceeds     17  
 
Item 3
      Defaults Upon Senior Securities     17  
 
Item 4
      Submission of Matters to a Vote of Security Holders     17  
 
Item 5
      Other Information     17  
 
Item 6
      Exhibits and Reports on Form 8-K     17  
 
      Signatures     18  
 
      Certifications     19  

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PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

Nabi Biopharmaceuticals

CONSOLIDATED BALANCE SHEETS                                  

                     
        (UNAUDITED)        
(Amounts in Thousands, Except Per Share Data)   March 29, 2003   December 28, 2002

 
 
Assets
               
Current assets:
               
 
Cash and cash equivalents
  $ 46,939     $ 51,737  
 
Trade accounts receivable, net
    29,440       36,326  
 
Inventories, net
    23,126       19,388  
 
Prepaid expenses and other current assets
    6,560       5,595  
 
   
     
 
   
Total current assets
    106,065       113,046  
Property, plant and equipment, net
    101,730       103,706  
Other assets:
               
 
Intangible assets, net
    15,178       13,050  
 
Other, net
    3,014       3,014  
 
   
     
 
Total assets
  $ 225,987     $ 232,816  
 
   
     
 
Liabilities and stockholders’ equity
               
Current liabilities:
               
 
Trade accounts payable
  $ 15,022     $ 21,654  
 
Accrued expenses
    15,909       16,897  
 
   
     
 
   
Total current liabilities
    30,931       38,551  
Other liabilities
    5,212       5,236  
 
   
     
 
   
Total liabilities
    36,143       43,787  
 
   
     
 
Stockholders’ equity:
               
 
Convertible preferred stock, par value $.10 per share:
           
 
   5,000 shares authorized; no shares outstanding
               
 
Common stock, par value $.10 per share: 75,000 shares authorized; 39,095 and 38,947 shares issued and outstanding, respectively
    3,910       3,895  
 
Capital in excess of par value
    160,017       159,568  
 
Treasury stock, 424 and 386 shares at cost
    (2,338 )     (2,140 )
 
Retained earnings
    28,255       27,706  
 
   
     
 
   
Total stockholders’ equity
    189,844       189,029  
 
   
     
 
Total liabilities and stockholders’ equity
  $ 225,987     $ 232,816  
 
   
     
 

See accompanying notes to consolidated financial statements

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Nabi Biopharmaceuticals

CONSOLIDATED STATEMENTS OF OPERATIONS

                   
      (UNAUDITED)
    For the Three Months Ended
(Amounts in Thousands, Except Per Share Data)   March 29, 2003   March 30, 2002

 
 
Sales
  $ 51,511     $ 40,969  
Costs and expenses:
               
 
Costs of products sold
    30,954       25,288  
 
Royalty expense
    3,915       1,559  
 
   
     
 
Gross margin
    16,642       14,122  
 
   
     
 
 
Selling, general and administrative expense
    10,139       9,183  
 
Research and development expense
    5,794       4,412  
 
Other operating expenses, principally amortization and freight
    190       198  
 
   
     
 
Operating income
    519       329  
Interest income
    206       647  
Interest expense
    (1 )     (1,867 )
Other income, net
    9       10  
 
   
     
 
Income (loss) before (provision) benefit for income taxes
    733       (881 )
(Provision) benefit for income taxes
    (184 )     220  
 
   
     
 
Net income (loss)
  $ 549     $ (661 )
 
   
     
 
Basic earnings (loss) per share:
  $ 0.01     $ (0.02 )
 
   
     
 
Diluted earnings (loss) per share:
  $ 0.01     $ (0.02 )
 
   
     
 
Basic weighted average shares outstanding
    38,962       38,523  
 
   
     
 
Diluted weighted average shares outstanding
    39,719       38,523  
 
   
     
 

See accompanying notes to consolidated financial statements

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Nabi Biopharmaceuticals

CONSOLIDATED STATEMENTS OF CASH FLOWS

                     
        (UNAUDITED)
        For the Three Months Ended
       
(Dollars in Thousands)   March 29, 2003   March 30, 2002

 
 
Cash flow from operating activities:
               
 
Net income (loss)
  $ 549     $ (661 )
 
Adjustments to reconcile net income (loss) to net cash used by operating activities:
               
   
Depreciation and amortization
    2,626       2,577  
   
Provision for doubtful accounts
    11       4  
   
Provision for slow moving or obsolete inventory
    51       (135 )
   
Write-off of loan origination fees
          400  
   
Other
          13  
 
Changes in assets and liabilities:
               
   
Decrease in trade accounts receivable
    6,875       9,165  
   
Increase in inventories
    (3,789 )     (2,268 )
   
(Increase) decrease in prepaid expenses and other assets
    (964 )     1,920  
   
Increase in other assets
          (20 )
   
Decrease in accounts payable and accrued liabilities
    (7,644 )     (14,125 )
 
   
     
 
   
Total adjustments
    (2,834 )     (2,469 )
 
   
     
 
Net cash used by operating activities
    (2,285 )     (3,130 )
 
   
     
 
Cash flow from investing activities:
               
   
Capital expenditures
    (562 )     (1,206 )
   
Expenditures for intangible asset
    (2,217 )     (326 )
 
   
     
 
Net cash used by investing activities
    (2,779 )     (1,532 )
 
   
     
 
Cash flow from financing activities:
               
   
Purchase of treasury stock
          (917 )
   
Proceeds from exercise of employee stock options
    266       504  
 
   
     
 
Net cash provided (used) by financing activities
    266       (413 )
 
   
     
 
Net decrease in cash and cash equivalents
    (4,798 )     (5,075 )
Cash and cash equivalents at beginning of period
    51,737       131,192  
 
   
     
 
Cash and cash equivalents at end of period
  $ 46,939     $ 126,117  
 
   
     
 

See accompanying notes to consolidated financial statements

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Nabi Biopharmaceuticals

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)

NOTE 1 OVERVIEW

Nabi Biopharmaceuticals discovers, develops, manufactures and markets products that power the immune system to help people with serious, unmet medical needs. We have a broad product portfolio and significant research capabilities focused on developing and commercializing novel vaccines and antibody-based biopharmaceutical products that prevent and treat infectious, autoimmune and addictive diseases, such as hepatitis B, hepatitis C and Staphylococcus aureus infections, immune thrombocytopenia purpura (“ITP”) and nicotine addiction. We have four marketed products, Nabi-HB® [Hepatitis B Immune Globulin (Human)] for the prevention of hepatitis B infections, WinRho SDF® [Rho (D) Immune Globulin Intravenous (Human)] for the treatment of acute, chronic and HIV-related ITP, Autoplex® T [Anti-Inhibitor Coagulant Complex, Heat Treated] and Aloprim™ [(Allopurinol sodium) for injection]. We have a significant clinical trials program including clinical trials of our lead investigational products, StaphVAX® (Staphylococcus aureus Polysaccharide Conjugate Vaccine), Altastaph™ [Staphylococcus aureus Immune Globulin (Human)], Civacir™ [Hepatitis C Immune Globulin (Human)], and NicVAX™ (Nicotine Conjugate Vaccine). We have a state-of-the-art fractionation facility for the manufacture of Nabi-HB and our investigational antibody products and for contract manufacturing. We also collect specialty and non-specific antibodies for use in our products as well as to supply pharmaceutical and diagnostic customers for the subsequent manufacture of their products.

The consolidated financial statements include the accounts of Nabi Biopharmaceuticals and its subsidiaries. All significant intercompany accounts and transactions were eliminated during consolidation. These statements should be read in conjunction with the Consolidated Financial Statements and Notes included in our Annual Report on Form 10-K for the year ended December 28, 2002.

In the opinion of management, the unaudited consolidated financial statements include all adjustments, consisting of normal recurring adjustments, which, in the opinion of management, are necessary to present fairly our consolidated financial position as of March 29, 2003, the consolidated results of our operations for the three months ended March 29, 2003 and March 30, 2002 and our cash flows for the three months then ended. The interim results of operations are not necessarily indicative of the results that may occur for the fiscal year.

NOTE 2 ACCOUNTING POLICIES

Accounting estimates: The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of sales and expenses during the reporting period. Actual results could differ from those estimates.

Basis of presentation: Certain items in the March 30, 2002 consolidated financial statements have been reclassified to conform to the current year’s presentation.

Stock-Based Compensation: On December 31, 2002, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards (“SFAS”) No. 148, Accounting for Stock-Based Compensation — Transition and Disclosure. This Statement amends SFAS No. 123, Accounting for Stock-Based Compensation, to provide alternative methods of transition for an entity that voluntarily changes to the fair value based method of accounting for stock-based employee compensation. It also amends the disclosure provisions of that Statement to require prominent disclosure about the effects on reported net income of an entity’s accounting policy decisions with respect to stock-based employee compensation. Finally, this Statement amends APB Opinion No. 28, Interim Financial Reporting, to require disclosure about those effects in interim financial information. We intend to continue to account for stock-based

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compensation based on the provisions of APB Opinion No. 25.

The following table summarizes our results as if we had recorded stock-based compensation expense for the three months ended March 29, 2003 and March 30, 2002, based on the provisions of SFAS 123, as amended by SFAS 148:

                   
      For the Three Months Ended
     
(Dollars in Thousands, except per share amounts)   March 29, 2003   March 30, 2002

 
 
Net income (loss):
               
 
As reported
  $ 549     $ (661 )
 
Compensation expense, net of tax
    (823 )     (807 )
 
 
   
     
 
 
Pro forma
  $ (274 )   $ (1,468 )
 
 
   
     
 
Basic earnings (loss) per share:
               
 
As reported
  $ 0.01     $ (0.02 )
 
Compensation expense, net of tax
    (0.02 )     (0.02 )
 
 
   
     
 
 
Pro forma
  $ (0.01 )   $ (0.04 )
 
 
   
     
 
Diluted earnings (loss) per share:
               
 
As reported
  $ 0.01     $ (0.02 )
 
Compensation expense, net of tax
    (0.02 )     (0.02 )
 
 
   
     
 
 
Pro forma
  $ (0.01 )   $ (0.04 )
 
 
   
     
 

NOTE 3 INVENTORIES

The components of inventories, stated at the lower of cost or market with cost determined on the first-in first-out (FIFO) method, are as follows:

                   
(Dollars in Thousands)   March 29, 2003   December 28, 2002

 
 
Finished goods
  $ 13,920     $ 12,142  
Work in process
    8,289       6,235  
Raw materials
    917       1,011  
 
   
     
 
 
Total
  $ 23,126     $ 19,388  
 
   
     
 

NOTE 4 EARNINGS PER SHARE

Basic earnings per share is computed by dividing our net income by the weighted average number of shares outstanding during the period.

When the effects are not anti-dilutive, diluted earnings per share is computed by dividing our net income by the weighted average number of shares outstanding and the impact of all dilutive potential common shares, primarily stock options. The dilutive impact of stock options is determined by applying the “treasury stock” method.

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     The following table reconciles net income (loss) and shares for the basic and diluted earnings (loss) per share computations:

                                                   
      For the Three Months Ended
     
(Amounts in Thousands, Except Per Share Amounts)   March 29, 2003   March 30, 2002

 
 
      Net           Per Share   Net           Per Share
      Income   Shares   Amount   Loss   Shares   Amount
     
 
 
 
 
 
Basic earnings (loss) per share
  $ 549       38,962     $ 0.01     $ (661 )     38,523     $ (0.02 )
Effect of dilutive securities:
                                               
 
Stock options and other dilutive securities
          757                          
 
 
   
     
     
     
     
     
 
Diluted earnings (loss) per share
  $ 549       39,719     $ 0.01     $ (661 )     38,523     $ (0.02 )
 
   
     
     
     
     
     
 

NOTE 5 OPERATING SEGMENT INFORMATION

     The following table presents information related to our two operating business segments:

                     
        For the Three Months Ended
       
(Dollars in Thousands)   March 29, 2003   March 30, 2002

 
 
Sales:
               
 
Biopharmaceutical products
  $ 22,660     $ 15,309  
 
Antibody products
    28,851       25,660  
 
 
   
     
 
   
Total
  $ 51,511     $ 40,969  
 
   
     
 
Gross Margin:
               
 
Biopharmaceutical products
  $ 15,467     $ 11,062  
 
Antibody products
    1,175       3,060  
 
 
   
     
 
   
Total
  $ 16,642     $ 14,122  
 
   
     
 
Operating income (loss):
               
 
Biopharmaceutical products
 </