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Table of Contents

 

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 31, 2005

 

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: 000-30231

 

TANOX, INC.

(Exact Name of Registrant as Specified in Its Charter)

 

Delaware   76-0196733
(State or Other Jurisdiction of
Incorporation or Organization)
  (IRS Employer
Identification No.)
10301 Stella Link
Houston, Texas
  77025
(Address of Principal Executive Offices)   (Zip Code)

 

(713) 578-4000

(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 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 ¨

 

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

 

Number of shares of common shares outstanding at May 3, 2005: 44,817,998.

 



Table of Contents

TANOX, INC.

FORM 10-Q FOR THE QUARTER ENDED MARCH 31, 2005

 

INDEX

 

     Page

Part I – Financial Information

    

Item 1 – Financial Statements

    

Condensed Consolidated Balance Sheets at March 31, 2005 and December 31, 2004

   1

Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) for the Three Months Ended March 31, 2005 and 2004

   2

Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2005 and 2004

   3

Notes to Condensed Consolidated Financial Statements

   4

Item 2 – Management’s Discussion and Analysis of Financial Condition and Results of Operations

   8

Item 3 – Quantitative and Qualitative Disclosures About Market Risk

   15

Item 4 – Controls and Procedures

   15

Part II – Other Information

    

Item 1 – Legal Proceedings

   16

Item 6 – Exhibits

   16

Signatures

   17

 

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Table of Contents

 

PART I

FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

TANOX, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(In Thousands, Except Shares and Per Share data)

 

     March 31,
2005


    December 31,
2004


 
     (Unaudited)        
ASSETS                 

CURRENT ASSETS:

                

Cash and cash equivalents

   $ 7,326     $ 5,284  

Restricted cash

     5,027       5,000  

Short-term investments

     136,661       152,960  

Interest receivable

     1,862       2,149  

Accounts receivable

     6,536       6,049  

Accounts receivable from related party

     47       44  

Prepaid expenses and other

     2,892       2,294  
    


 


Total current assets

     160,351       173,780  

LONG-TERM INVESTMENTS

     33,692       39,267  

PROPERTY PLANT & EQUIPMENT, NET

     29,694       25,506  

OTHER ASSETS

     2,016       —    
    


 


TOTAL ASSETS

   $ 225,753     $ 238,553  
    


 


LIABILITIES AND STOCKHOLDERS’ EQUITY                 

CURRENT LIABILITIES:

                

Accounts payable

   $ 4,337     $ 2,399  

Accrued liabilities

     3,790       6,092  

Accrued arbitration award

     1,263       864  
    


 


Total current liabilities

     9,390       9,355  
    


 


LONG –TERM LIABILITIES:

                

Note payable to bank

     5,000       5,000  
    


 


Total long-term liabilities

     5,000       5,000  
    


 


STOCKHOLDERS’ EQUITY:

                

Preferred stock, $.01 par value; 10,000,000 shares authorized; none outstanding

     —         —    

Common stock, $.01 par value; 120,000,000 shares authorized; 45,362,298 and 44,531,998 shares issued, and 44,807,598 and 43,977,298 shares outstanding in 2005 and 2004, respectively

     454       445  

Additional paid-in capital

     330,630       322,671  

Treasury stock, at cost; 554,700 shares in 2005 and 2004, respectively

     (6,261 )     (6,261 )

Accumulated other comprehensive income

     837       1,178  

Accumulated deficit

     (114,297 )     (93,835 )
    


 


Total stockholders’ equity

     211,363       224,198  
    


 


TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

   $ 225,753     $ 238,553  
    


 


 

See accompanying notes to condensed consolidated financial statements.

 

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TANOX, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE

INCOME (LOSS)

(Unaudited)

(In Thousands, Except Per Share data)

 

     Three Months Ended March 31,

 
     2005

    2004

 

REVENUES:

                

Royalties, net of arbitration award

   $ 5,875     $ 2,239  

Royalties from related party, net of arbitration award

     34       11  

Development agreements and licensing fees

     10       3,372  

Development agreements from related party

     9       3,372  
    


 


Total revenues

     5,928       8,994  
    


 


OPERATING EXPENSES:

                

Research and development

     11,740       5,528  

Acquired in-process research and development

     13,680       —    

General and administrative

     1,933       1,696  
    


 


Total operating expenses

     27,353       7,224  
    


 


INCOME (LOSS) FROM OPERATIONS

     (21,425 )     1,770  
    


 


OTHER INCOME (EXPENSES):

                

Interest income

     1,034       965  

Interest expense

     (45 )     (76 )

Other, net

     (26 )     (69 )
    


 


Total other income

     963       820  
    


 


NET INCOME (LOSS)

   $ (20,462 )   $ 2,590  
    


 


BASIC EARNINGS (LOSS) PER SHARE

   $ (0.46 )   $ 0.06  
    


 


DILUTED EARNINGS (LOSS) PER SHARE

   $ (0.46 )   $ 0.06  
    


 


SHARES USED IN COMPUTING EARNINGS (LOSS) PER SHARE:

                

Basic

     44,050       43,997  
    


 


Diluted

     44,050       44,487  
    


 


COMPREHENSIVE INCOME (LOSS):

                

Net income (loss)

   $ (20,462 )   $ 2,590  

Unrealized gain (loss) on available-for-sale investment

     (341 )     521  
    


 


TOTAL COMPREHENSIVE INCOME (LOSS)

   $ (20,803 )   $ 3,111  
    


 


 

See accompanying notes to condensed consolidated financial statements.

 

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TANOX, INC

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

(In Thousands)

 

     Three Months Ended March 31,

 
     2005

    2004

 

CASH FLOWS FROM OPERATING ACTIVITIES:

                

Net income (loss)

   $ (20,462 )   $ 2,590  

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

                

Depreciation and amortization

     947       543  

Acquired in-process research and development

     13,680       —    

Compensation expense related to stock options

     15       —    

Changes in operating assets and liabilities:

                

(Increase) decrease in receivables and other assets

     (2,817 )     170  

(Decrease) increase in current liabilities

     35       (9,916 )
    


 


Net cash used in operating activities

     (8,602 )     (6,613 )
    


 


CASH FLOWS FROM INVESTING ACTIVITIES:

                

Additions to property and equipment

     (5,135 )     (4,675 )

Cash paid for acquisition of in-process research and development

     (6,000 )     —    

Purchases of investments

     (47,792 )     (114,296 )

Maturities and sales of investments

     69,325       115,431  

Decrease (increase) in restricted cash

     (27 )     6,888  

Loss on disposal of PP&E

     —         27  
    


 


Net cash provided by investing activities

     10,371       3,375  
    


 


CASH FLOWS FROM FINANCING ACTIVITIES:

                

Proceeds from issuance of stock

     273       168  
    


 


Net cash provided by financing activities

     273       168  
    


 


INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

     2,042       (3,070 )

CASH AND CASH EQUIVALENTS:

                

Beginning of period

     5,284       21,450  
    


 


End of period

   $ 7,326     $ 18,380  
    


 


SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:

                

Capital contribution from forgiveness of note payable by a related party

     —         10,000  

Capital contribution from forgiveness of interest by a related party

     —         742  

Unrealized gain (loss) on available-for-sale security

     (341 )     521  

Common stock issued for acquisition of in-process research and development

     7,680       —    

 

See accompanying notes to condensed consolidated financial statements.

 

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TANOX, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2005

(UNAUDITED)

 

1. Basis of Consolidation

 

The accompanying unaudited condensed consolidated interim financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X and include the accounts of Tanox, Inc. and its wholly owned subsidiary (collectively the Company or Tanox). Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles in the United States for complete financial statements. In the opinion of management, all adjustments considered necessary for fair presentation have been included. All such adjustments are of a normal recurring nature. These condensed consolidated interim financial statements and notes thereto should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2004. Operating results for the three month period ended March 31, 2005 are not necessarily indicative of the operating results that may be expected for the year ending December 31, 2005.

 

2. Reclassification

 

As of March 31, 2004, Tanox reclassified auction rate securities of $52.8 million from cash and cash equivalents to short-term investments. The accompanying consolidated statement of cash flows for the three months ended March 31, 2004 has been adjusted to reflect these reclassifications.

 

3. Revenues

 

Development Agreements and Licensing Fees. Development agreement revenue includes reimbursement from Genentech, Inc. and Novartis Pharma A.G. of selected current quarter clinical trial costs incurred for TNX-901. Licensing fee revenue includes payments received in exchange for rights to license and sublicense Tanox’s technology or product rights. No licensing fee revenue has been recorded in 2005.

 

Royalties. Royalty revenue of $5.9 million and $2.3 million on the net sales of Xolair® (omalizumab), for the three-month periods ended March 31, 2005 and 2004, respectively, were calculated based on net sales reported to Tanox by Genentech and Novartis. Royalty revenue is net of amounts which are payable by Tanox to its former attorneys (see Note 9. Commitments and Contingencies).

 

In the United States, Tanox receives royalties on sales of Xolair and other collaboration products and will receive a share of Novartis’ profits on these sales. The Company also receives royalties on sales of Xolair and other collaboration products outside the U.S. Tanox shares equally with Novartis the net profits and net losses from sales of Xolair and other collaboration products in East Asia. Novartis profit sharing and rest-of-world royalty payments will be net of certain other credits, which, at March 31, 2005, approximated $2.0 million. In addition, as a result of an adverse arbitration award, 10% of all royalties received by Tanox on sales of Xolair and certain other anti-IgE products will be payable to its former attorneys, up to a maximum of $300 million. The Company expects that the net amount it will receive from Xolair sales, taking into account both the foregoing credit and the amount payable to its former attorneys, will be in the range of 8% to 12% of net sales depending on the sales level achieved and geographic distribution of the sales.

 

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4. Cash, Cash Equivalents, Short-term and Long-term Investments

 

Cash equivalents consist of highly-liquid investments with original maturities of three months or less. Management determines the appropriate classification of its cash equivalents, short-term investments and long-term investments at the time of purchase. Investments consist of investment grade corporate bonds, commercial paper, asset-backed securities, auction-rate securities and government agency securities with maturities of less than three years from the balance sheet date. Certain investments are classified as held-to-maturity and carried at amortized cost in the accompanying financial statements. The Company’s available-for-sale investments are stated at fair value based on the quoted market price of the investment. Unrealized gains and losses on available-for-sale investments are reported as other comprehensive income (loss), which is a separate component of stockholders’ equity. For the three months ended March 31, 2005, the fair value of Tanox’s available-for-sale investments decreased by $341,000 versus an increase in value of $521,000 for the three months ended March 31, 2004. The changes in fair value were recorded as an unrealized gain or loss and is included as a component of stockholders’ equity.

 

Tanox’s net carrying value of cash and cash equivalents (including restricted cash) at March 31, 2005 and December 31, 2004, was $12.4 million and $10.3 million, respectively.

 

Investments consist of the following (in thousands):

 

     March 31, 2005

   December 31, 2004

Held-to-maturity investments – short-term

   $ 114,033    $ 115,241

Available-for-sale investments

     22,628      37,719
    

  

Total short-term investments

     136,661      152,960

Held-to-maturity investments – long-term

     33,692      39,267
    

  

     $ 170,353    $ 192,227
    

  

 

The fair value of these investments at March 31, 2005 and December 31, 2004, was $169.4 million and $191.4 million, respectively.

 

5. Acquisitions

 

Manufacturing Assets and Long-term Lease

 

Pursuant to a Lease Assignment and Asset Purchase Agreement dated December 9, 2004, between Biogen IDEC, Inc. and Tanox, on January 10, 2005, Tanox acquired from Biogen IDEC certain manufacturing, process development and QC equipment, related documentation and furniture and fixtures housed in a 76,000 square foot leased facility located in San Diego, California. Tanox also agreed to assume the obligations of Biogen IDEC under the triple net lease for the facility, which extends until October 2011, with two five-year extension options. The lease payments for 2005 will be approximately $3.8 million and will increase annually over the term of the lease, including extension periods, at a rate of approximately 4%. As partial consideration for Tanox’s agreement to the extension of the lease term to September 30, 2011, and assuming Tanox is not then in default under the lease agreement, Biogen IDEC agreed to make two payments to Tanox, each in the amount of approximately $2.4 million, on September 30, 2007 and November 30, 2008. We expect the total future lease obligation of Tanox for this lease assignment through 2011, net of the Biogen IDEC payments, will be approximately $24.6 million. The Company paid Biogen IDEC approximately $5.6 million for the assets. The Company is in the process of finalizing the purchase price allocation of the acquired assets. Our preliminary allocation consists of approximately $4.1 million, classified as property, plant and equipment and the balance of $1.5 million, the cost of the documentation related to the purchased manufacturing equipment, classified as an other asset. The Company does not anticipate that the final purchase price allocation will have a material impact on operating results in future periods.

 

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Anti-Tissue Factor Program

 

On March 31, 2005, the Company acquired a tissue factor antagonist program for the potential treatment of inflammatory disease and cancer from Sunol Molecular Corp. In consideration for the tissue factor antagonist program, the Company issued an aggregate of 800,000 shares of its common stock and paid $6.0 million in cash to Sunol. Of the shares issued, 275,000 shares issued will be held in escrow for up to three years after closing to secure indemnification obligations under the Asset Purchase Agreement. As part of the program, the Company received all tissue factor antagonist assets of Sunol, including anti-tissue factor monoclonal antibodies and related technologies and intellectual property, as well as non-exclusive rights to certain technologies and related intellectual property for protein and antibody expression. Based upon the closing price of the Company’s common stock on March 31, 2005, the fair value of the acquired assets was $13.7 million, including the $6 million paid in cash. As of the acquisition date, the acquired program was still in early development stage, had not reached technological feasibility and had no alternative future use. Accordingly, the Company recorded $13.7 million as an acquired in-process research and development expense.

 

6. Line of Credit Note