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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 September 27, 2003

OR

     
[   ]   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   (I.R.S. Employer Identification No.)
incorporation or organization)    

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 [   ] No

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

The number of shares outstanding of the registrant’s common stock, par value $0.10 per share, at October 22, 2003 was 46,659,503 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
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 Reports on Form 8-K
SIGNATURES
EX-10.1 Letter Agreement with David J. Gury
EX-31.1 CEO Cert. Rule 13a-14(a)/15d-14a
EX-31.2 CFO Cert. Rule 13a-14(a)/15d-14a
EX-32.1 Section 1350 Certification of CEO & CFO


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Nabi Biopharmaceuticals

INDEX

             
        Page No.
PART I. FINANCIAL INFORMATION
       
 
Item 1.
Financial Statements
    3  
   
- Consolidated Balance Sheets, as of September 27, 2003 (unaudited) and December 28, 2002
    3  
   
- Consolidated Statements of Operations for the Three Months and Nine Months Ended September 27, 2003 and September 28, 2002 (unaudited)
    4  
   
- Consolidated Statements of Cash Flows for the Nine Months Ended September 27, 2003 and September 28, 2002 (unaudited)
    5  
   
- Notes to Consolidated Financial Statements (unaudited)
    6  
 
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
    15  
 
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
    26  
 
Item 4.
Controls and Procedures
    26  
PART II. OTHER INFORMATION
       
 
Item 1.
Legal Proceedings
    27  
 
Item 2.
Changes in Securities and Use of Proceeds
    27  
 
Item 3.
Defaults Upon Senior Securities
    28  
 
Item 4.
Submission of Matters to a Vote of Security Holders
    28  
 
Item 5.
Other Information
    28  
 
Item 6.
Exhibits and Reports on Form 8-K
    28  
   
Signatures
    29  
   
Certifications
    30  

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PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

Nabi Biopharmaceuticals

CONSOLIDATED BALANCE SHEETS

                       
          (UNAUDITED)        
          September 27,   December 28,
(Amounts in Thousands)   2003   2002

 
 
Assets
               
Current assets:
               
 
Cash and cash equivalents
  $ 26,248     $ 51,737  
 
Trade accounts receivable, net
    35,954       36,326  
 
Inventories, net
    25,819       19,388  
 
Prepaid expenses and other current assets
    5,224       5,595  
 
   
     
 
     
Total current assets
    93,245       113,046  
Property, plant and equipment, net
    100,444       104,066  
Other assets:
               
 
Intangible assets, net
    109,390       12,690  
 
Other, net
    3,948       3,014  
 
   
     
 
Total assets
  $ 307,027     $ 232,816  
 
   
     
 
Liabilities and stockholders’ equity
               
Current liabilities:
               
 
Trade accounts payable
  $ 7,826     $ 21,654  
 
Accrued expenses
    23,944       16,897  
 
Notes payable, PhosLo acquisition
    4,014        
 
Notes payable
    2,000        
 
   
     
 
     
Total current liabilities
    37,784       38,551  
Notes payable, PhosLo acquisition
    23,047        
Notes payable
    8,000        
Other liabilities
    7,129       5,236  
 
 
   
     
 
     
Total liabilities
    75,960       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; 47,239 and 38,947 shares outstanding, respectively
    4,724       3,895  
 
Capital in excess of par value
    204,134       159,568  
 
Treasury stock, 800 and 386 shares at cost
    (5,240 )     (2,140 )
 
Retained earnings
    27,449       27,706  
 
   
     
 
   
Total stockholders’ equity
    231,067       189,029  
 
   
     
 
Total liabilities and stockholders’ equity
  $ 307,027     $ 232,816  
 
   
     
 

See accompanying notes to consolidated financial statements

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Nabi Biopharmaceuticals

CONSOLIDATED STATEMENTS OF OPERATIONS

                                     
                (UNAUDITED)        
        For the Three Months   For the Nine Months
        Ended   Ended
       
 
        September   September   September   September
(Amounts in Thousands, Except Per Share Data)   27, 2003   28, 2002   27, 2003   28, 2002

 
 
 
 
Sales
  $ 42,435     $ 46,100     $ 128,595     $ 137,871  
Costs and expenses:
                               
   
Costs of products sold
    16,101       26,352       62,781       81,649  
   
Royalty expense
    5,423       4,249       13,722       10,105  
 
   
     
     
     
 
 
Gross margin
    20,911       15,499       52,092       46,117  
   
Selling, general and administrative expense
    9,351       8,732       32,189       28,155  
   
Research and development expense
    6,454       5,597       18,183       14,939  
   
Other operating expense, principally amortization and freight
    1,588       153       1,953       551  
 
   
     
     
     
 
Operating income (loss)
    3,518       1,017       (233 )     2,472  
Interest income
    131       192       502       1,085  
Interest expense
    (506 )     (95 )     (570 )     (2,039 )
Other income (expense), net
    12       13       30       (169 )
 
   
     
     
     
 
Income (loss) before (provision) benefit for income taxes
    3,155       1,127       (271 )     1,349  
(Provision) benefit for income taxes
    (962 )     (302 )     14       (364 )
 
   
     
     
     
 
Net income (loss)
  $ 2,193     $ 825     $ (257 )   $ 985  
 
   
     
     
     
 
Basic earnings (loss) per share
  $ 0.05     $ 0.02     $ (0.01 )   $ 0.03  
 
   
     
     
     
 
Diluted earnings (loss) per share
  $ 0.05     $ 0.02     $ (0.01 )   $ 0.02  
 
   
     
     
     
 
Basic weighted average shares outstanding
    45,355       38,704       41,152       38,625  
 
   
     
     
     
 
Diluted weighted average shares outstanding
    46,285       39,299       41,152       39,611  
 
   
     
     
     
 

See accompanying notes to consolidated financial statements

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Nabi Biopharmaceuticals

CONSOLIDATED STATEMENTS OF CASH FLOWS

                     
        (UNAUDITED)
        For the Nine Months Ended
       
        September 27,   September 28,
(Dollars in Thousands)   2003   2002

 
 
Cash flow from operating activities:
               
 
Net income
  $ (257 )   $ 985  
 
Adjustments to reconcile net income to net cash used in operating activities:
               
   
Depreciation and amortization
    9,422       7,465  
   
(Recovery) provision for doubtful accounts
    (3 )     391  
   
Provision for slow moving or obsolete inventory
    1,641       23  
   
Write-off of loan origination fees
          400  
   
Non-cash compensation
    689       334  
   
Imputed interest on notes payable
    201        
   
Write-off obsolete fixed assets
    23       269  
 
Changes in assets and liabilities:
               
   
Decrease in trade accounts receivable
    375       706  
   
Increase in inventories
    (7,918 )     (3,564 )
   
Decrease in prepaid expenses and other assets
    372       2,382  
   
Increase in other assets
    (1,027 )     (20 )
   
Decrease in accounts payable and accrued liabilities
    (5,314 )     (10,704 )
 
   
     
 
   
Total adjustments
    (1,539 )     (2,318 )
 
   
     
 
Net cash used in operating activities
    (1,796 )     (1,333 )
 
   
     
 
Cash flow from investing activities:
               
   
Capital expenditures
    (4,082 )     (4,841 )
   
Expenditures for other assets
    (2,019 )     (2,760 )
   
Acquisition of PhosLo
    (61,255 )      
 
   
     
 
Net cash used in investing activities
    (67,356 )     (7,601 )
 
   
     
 
Cash flow from financing activities:
               
   
Borrowings under debt agreement
    10,000        
   
Proceeds from the issuance of common stock
    31,270          
   
Retirement of convertible subordinated notes
          (78,500 )
   
Purchase of treasury stock
          (917 )
   
Proceeds from exercise of employee stock options
    2,393       699  
 
   
     
 
Net cash provided by (used in) financing activities
    43,663       (78,718 )
 
   
     
 
Net decrease in cash and cash equivalents
    (25,489 )     (87,652 )
Cash and cash equivalents at beginning of period
    51,737       131,192  
 
   
     
 
Cash and cash equivalents at end of period
  $ 26,248     $ 43,540  
 
   
     
 

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 therapies that prevent and treat infectious, autoimmune and addictive diseases, such as Staphylococcus aureus and hepatitis infections, immune thrombocytopenia purpura (“ITP”) and nicotine addiction. We have five 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, PhosLo® (calcium acetate) for the control of elevated phosphate levels (hyperphosphatemia) in patients with end-stage kidney (renal) failure, 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 September 27, 2003 and September 28, 2002, the consolidated results of our operations for the three months and nine months ended September 27, 2003 and September 28, 2002 and our cash flows for the nine 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.

New accounting pronouncements: In January 2003, the Financial Accounting Standards Board issued Interpretation No. 46, “Consolidation of Variable Interest Entities, an interpretation of ARB No. 51” (“FIN 46”). FIN 46 addresses the consolidation of entities whose equity holders have either (a) not provided sufficient equity at risk to allow the entity to finance its own activities or (b) do not possess certain characteristics of a controlling financial interest. FIN 46 requires the consolidation of these entities, known as variable interest entities (“VIE’s”), by the primary beneficiary of the entity. The primary beneficiary is the entity, if any, that is subject to a majority of the risk of loss from the VIE’s activities, entitled to receive a majority of the VIE’s residual returns, or both. FIN 46 applies immediately to variable interests in VIEs created or obtained after January 31, 2003. As amended by FASB Staff Position (“FSP”) No. FIN 46-6, FIN 46 is effective for variable interests in a VIE created before February 1, 2003 at the end of the first interim or annual period ending after December 15, 2003 (the end of fiscal 2003, December 27, 2003, for the Company). We are currently reviewing the potential impact of FIN 46 on our financial statements.

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Basis of presentation: Certain items in the 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 Accounting Principles Board (“APB”) Opinion No. 28, Interim Financial Reporting, to require disclosure about those effects in interim financial information. We continue to account for stock-based compensation based on the provisions of APB Opinion No. 25, Accounting for Stock Issued to Employees.

The following table summarizes our results as if we had recorded stock-based compensation expense for the three months ended September 27, 2003 and September 28, 2002 and for the nine months then ended, based on the provisions of SFAS 123, as amended by SFAS 148:

                   
      For the Three Months Ended
     
(Dollars in Thousands, except per share amounts)   September 27, 2003   September 28, 2002

 
 
Net income (loss):
               
 
As reported
  $ 2,193     $ 825  
 
Compensation expense, net of tax
    (1,982 )     (1,586 )
 
 
   
     
 
 
Pro forma
  $ 211     $ (761 )
 
 
   
     
 
Basic earnings (loss) per share:
               
 
As reported
  $ 0.05     $ 0.02  
 
Compensation expense, net of tax
    (0.04 )     (0.04 )
 
 
   
     
 
 
Pro forma
  $ 0.01     $ (0.02 )
 
 
   
     
 
Diluted earnings (loss) per share:
               
 
As reported
  $ 0.05     $ 0.02  
 
Compensation expense, net of tax
    (0.04 )     (0.04 )
 
 
   
     
 
 
Pro forma
  $ 0.01     $ (0.02 )
 
 
   
     
 
                   

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      For the Nine Months Ended
     
(Dollars in Thousands, except per share amounts)   September 27, 2003   September 28, 2002

 
 
Net (loss) income:
               
 
As reported
  $ (257 )   $ 985  
 
Compensation expense, net of tax
    (6,222 )     (3,114 )
 
 
   
     
 
 
Pro forma
  $ (6,480 )   $ (2,129 )
 
 
   
     
 
Basic (loss) earnings per share:
               
 
As reported
  $ (0.01 )   $ 0.03  
 
Compensation expense, net of tax
    (0.15 )     (0.09 )
 
 
   
     
 
 
Pro forma
  $ (0.16 )   $ (0.06 )
 
 
   
     
 
Diluted (loss) earnings per share:
               
 
As reported
  $ (0.01 )   $ 0.02  
 
Compensation expense, net of tax
    (0.15 )     (0.08 )
 
 
   
     
 
 
Pro forma
  $ (0.16