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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 27, 2004

 

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

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    ¨  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 April 21, 2004 was 57,561,012 shares.

 



Table of Contents

Nabi Biopharmaceuticals

 

INDEX

 

          Page No.

PART I.

   FINANCIAL INFORMATION     

        Item 1.

   Financial Statements    3
    

-         Condensed Consolidated Balance Sheets, as of March 27, 2004 (unaudited) and December 27, 2003

   3
    

-         Condensed Consolidated Statements of Operations (unaudited) for the Three Months Ended March 27, 2004 and March 29, 2003

   4
    

-         Condensed Consolidated Statements of Cash Flows (unaudited) for the Three Months Ended March 27, 2004 and March 29, 2003

   5
    

-         Notes to Condensed Consolidated Financial Statements (unaudited)

   6

        Item 2.

   Management’s Discussion and Analysis of Financial Condition and Results of Operations    14

        Item 3.

   Quantitative and Qualitative Disclosures About Market Risk    22

        Item 4.

   Controls and Procedures    23

PART II.

   OTHER INFORMATION     

        Item 1.

   Legal Proceedings    24

        Item 2.

   Changes in Securities and Use of Proceeds and Issuer Purchases of Equity Securities    24

        Item 3.

   Defaults Upon Senior Securities    24

        Item 4.

   Submission of Matters to a Vote of Security Holders    24

        Item 5.

   Other Information    24

        Item 6.

   Exhibits and Reports on Form 8-K    24
     Signatures    25
     Certifications     

 

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PART I. FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

Nabi Biopharmaceuticals

 

CONDENSED CONSOLIDATED BALANCE SHEETS

 

(In thousands, except for share and per share amounts)


  

(UNAUDITED)
March 27,

2004


    December 27,
2003


 

Assets

                

Current assets:

                

Cash and cash equivalents

   $ 116,779     $ 115,756  

Trade accounts receivable, net

     36,904       37,062  

Inventories, net

     21,162       23,483  

Prepaid expenses and other current assets

     8,854       10,284  
    


 


Total current assets

     183,699       186,585  

Property, plant and equipment, net

     100,874       101,831  

Other assets:

                

Intangible assets, net

     94,292       94,991  

Other, net

     3,740       3,894  
    


 


Total assets

   $ 382,605     $ 387,301  
    


 


Liabilities and stockholders’ equity

                

Current liabilities:

                

Trade accounts payable

   $ 14,298     $ 10,874  

Accrued expenses

     21,803       23,956  

Current portion of notes payable, PhosLo acquisition, net

     8,233       4,226  
    


 


Total current liabilities

     44,334       39,056  

Notes payable, PhosLo acquisition, less current portion, net

     15,372       23,167  

Other liabilities

     5,536       5,762  
    


 


Total liabilities

     65,242       67,985  

Stockholders’ equity:

                

Convertible preferred stock, par value $.10 per share: 5,000,000 authorized; no shares outstanding

     —         —    

Common stock, par value $.10 per share: 75,000,000 authorized; 58,169,911 and 57,772,302 shares outstanding, respectively

     5,817       5,773  

Capital in excess of par value

     300,743       297,909  

Treasury stock, 800,315 shares at cost

     (5,240 )     (5,240 )

Retained earnings

     16,035       20,874  

Other accumulated comprehensive income

     8       —    
    


 


Total stockholders’ equity

     317,363       319,316  
    


 


Total liabilities and stockholders’ equity

   $ 382,605     $ 387,301  
    


 


 

See accompanying notes to consolidated financial statements.

 

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Nabi Biopharmaceuticals

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

     (UNAUDITED)

 
     For the Three Months Ended

 

(In thousands, except per share amounts)


   March 27, 2004

    March 29, 2003

 

Sales

   $ 46,349     $ 51,511  

Costs and expenses:

                

Costs of products sold

     20,200       30,954  

Royalty expense

     3,575       3,915  
    


 


Gross margin

     22,574       16,642  

Selling, general and administrative expense

     12,356       10,139  

Research and development expense

     11,429       5,794  

Amortization of intangible assets

     2,153       88  

Other operating expense, principally freight

     63       102  
    


 


Operating (loss) income

     (3,427 )     519  

Interest income

     336       206  

Interest expense

     (1,490 )     (1 )

Other (expense) income, net

     (1 )     9  
    


 


(Loss) income before provision for income taxes

     (4,582 )     733  

Provision for income taxes

     (257 )     (184 )
    


 


Net (loss) income

   $ (4,839 )   $ 549  
    


 


Basic (loss) earnings per share

   $ (0.08 )   $ 0.01  
    


 


Diluted (loss) earnings per share

   $ (0.08 )   $ 0.01  
    


 


Basic weighted average shares outstanding

     57,960       38,962  
    


 


Diluted weighted average shares outstanding

     57,960       39,719  
    


 


 

See accompanying notes to consolidated financial statements.

 

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Nabi Biopharmaceuticals

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

 

     (UNAUDITED)

 
     For the Three Months Ended

 

(In thousands)


   March 27, 2004

    March 29, 2003

 

Cash flow from operating activities:

                

Net (loss) income

   $ (4,839 )   $ 549  

Adjustments to reconcile net (loss) income to net cash provided by (used in) operating activities:

                

Depreciation and amortization

     4,739       2,626  

Provision for doubtful accounts

     144       11  

Provision for slow moving or obsolete inventory

     310       51  

Write-off of loan origination fees

     539       —    

Gain on sale of assets

     (119 )     —    

Write-off of obsolete fixed assets

     145       —    

Changes in assets and liabilities:

                

Decrease in trade accounts receivable

     15       6,875  

Decrease (increase) in inventories

     1,966       (3,789 )

Decrease (increase) in prepaid expenses and other current assets

     1,042       (964 )

Increase in other assets

     (38 )     —    

Increase (decrease) in accounts payable and accrued liabilities

     1,022       (7,644 )
    


 


Total adjustments

     9,765       (2,834 )
    


 


Net cash provided by (used in) operating activities

     4,926       (2,285 )
    


 


Cash flow from investing activities:

                

Proceeds from sales of assets

     179       —    

Capital expenditures

     (1,424 )     (562 )

Expenditures for Manufacturing Rights

     (1,453 )     (2,217 )
    


 


Net cash used in investing activities

     (2,698 )     (2,779 )
    


 


Cash flow from financing activities:

                

Payment of notes payable, PhosLo acquisition

     (4,083 )     —    

Proceeds from exercise of employee stock options

     2,878       266  
    


 


Net cash (used in) provided by financing activities

     (1,205 )     266  
    


 


Net increase (decrease) in cash and cash equivalents

     1,023       (4,798 )

Cash and cash equivalents at beginning of period

     115,756       51,737  
    


 


Cash and cash equivalents at end of period

   $ 116,779     $ 46,939  
    


 


 

See accompanying notes to consolidated financial statements.

 

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Nabi Biopharmaceuticals

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

NOTE 1 OVERVIEW

 

We apply our knowledge of the human immune system to develop and commercialize products that address serious, unmet medical needs. Our focus is in the areas of infectious, autoimmune and addictive diseases. In addition to five marketed products (PhosLo®, Nabi-HB®, WinRho SDF®, Aloprim and Autoplex® T), we have four products in clinical trials. We expect to file a Marketing Authorization Approval, or MAA, for StaphVAX® in the European Union, or EU, in 2004 based on existing clinical data. For U.S. licensure, we have advanced StaphVAX to confirmatory Phase III clinical trial development and anticipate completing enrollment in this trial in the third quarter of 2004. We anticipate filing a Biologics License Application, or BLA, for StaphVAX by the end of 2005. StaphVAX is designed to prevent the most dangerous and prevalent strains of Staph aureus bacterial infections, which are a major cause of hospital and community-acquired infections, and Staph aureus bacteria are becoming increasingly resistant to antibiotics. Our other products in development are Altastaph, an antibody based product for prevention of Staph aureus infections, Civacir, an antibody based product for preventing hepatitis C re-infection in liver transplant patients and NicVAX, a nicotine vaccine. Altastaph and NicVAX are currently in Phase II clinical trials. Civacir has completed a Phase I/II clinical trial. We have a state-of-the-art fractionation facility for the manufacture of Nabi-HB and our investigational antibody products, Altastaph and Civacir, and for contract manufacturing. We also collect specialty and non-specific antibodies for use in our products and supply pharmaceutical and diagnostic customers our excess production for the subsequent manufacture of their products.

 

We are headquartered in Boca Raton, Florida and maintain research and development facilities in Rockville, Maryland and have wholly owned foreign subsidiaries located in Ireland for the purpose of facilitating the regulatory approval, sales and marketing of our products in Europe.

 

The condensed 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 27, 2003.

 

In the opinion of management, the unaudited condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments, which are necessary to present fairly our consolidated financial position as of March 27, 2004 and December 27, 2003, the consolidated results of our operations for the three months ended March 27, 2004 and March 29, 2003 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 full fiscal year.

 

NOTE 2 ACCOUNTING POLICIES

 

Accounting estimates: The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. 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 2003 consolidated financial statements have been reclassified to conform to the current year’s presentation.

 

New accounting pronouncements: In January 2003, the Financial Accounting Standards Board, or FASB, issued Interpretation No. 46, Consolidation of Variable Interest Entities, an interpretation of ARB No. 51, or 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, or VIE’s, by the primary beneficiary entity. The primary beneficiary is the entity,

 

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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, or 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 us). We have no interests in VIEs and accordingly, the adoption of FIN 46 had no impact on our financial statements.

 

In May 2003, the FASB issued SFAS No. 150, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity. SFAS No. 150 establishes standards for how companies classify and measure certain financial instruments with characteristics of both liabilities and equity. It requires companies to classify a financial instrument that is within its scope as a liability, or an asset, in some circumstances. SFAS No. 150 is effective beginning with the second quarter of fiscal 2004. We do not currently have financial instruments with characteristics of both liabilities and equity, and therefore, the adoption of SFAS No. 150 is not expected to have an impact on our financial condition, results of operations or cash flows.

 

Comprehensive Income (Loss): The Company follows SFAS No. 130, Reporting Comprehensive Income, which computes comprehensive income as the total of net income and all other changes in shareholders’ equity. For the quarter ended March 27, 2004, comprehensive loss included net loss and the effect of foreign currency translation adjustments. For the quarter ended March 29, 2003, there were no comprehensive income items other than net income.

 

Stock-Based Compensation: On December 31, 2002, the FASB issued Statement of Financial Accounting Standards, or 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, or 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 March 27, 2004 and March 29, 2003, based on the provisions of SFAS No. 123, as amended by SFAS No. 148:

 

     For the Three Months Ended

 

(In thousands, except per share amounts)


   March 27, 2004

    March 29, 2003

 

Net (loss) income:

                

As reported

   $ (4,839 )   $ 549  

Add: Stock-based employee compensation expense included in reported net (loss) income, net of tax

     97       —    

Deduct: Total stock-based employee compensation expense determined under fair value based method, net of tax

     (1,808 )     (823 )
    


 


Pro forma

   $ (6,550 )   $ (274 )
    


 


Basic (loss) earnings per share:

                

As reported

   $ (0.08 )   $ 0.01  

Add: Stock-based employee compensation expense included in reported net (loss) income, net of tax

     —         —    

Deduct: Total stock-based employee compensation expense determined under fair value based method, net of tax

     (0.03 )     (0.02 )