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Table of Contents

 

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 10-Q

 

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended July 4, 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 0-21794

 

GTC BIOTHERAPEUTICS, INC.

(Exact Name of Registrant as Specified in Its Charter)

 

Massachusetts   04-3186494

(State or Other Jurisdiction of

Incorporation or Organization)

 

(I.R.S. Employer

Identification No.)

 

175 Crossing Boulevard, Framingham, Massachusetts   01702
(Address of Principal Executive Offices)   (Zip Code)

 

Registrant’s Telephone Number, Including Area Code (508) 620-9700

 

 


Former Name, Former Address and Former Fiscal Year if Changed Since Last Report

 

Indicate by check 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 whether registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).

 

Yes  x    No  ¨

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

 

Class


 

Outstanding at August 3, 2004


Common Stock, $0.01 par value

  38,740,165

 


 


Table of Contents

GTC BIOTHERAPEUTICS, INC.

TABLE OF CONTENTS

 

     PAGE #

PART I. FINANCIAL INFORMATION

    

ITEM 1 - Unaudited Consolidated Financial Statements

    

Consolidated Balance Sheets as of July 4, 2004 and December 28, 2003

   2

Consolidated Statements of Operations and Comprehensive Loss for the Three Months and Six Months Ended July 4, 2004 and June 29, 2003

   3

Consolidated Statements of Cash Flows for the Six Months Ended July 4, 2004 and June 29, 2003

   4

Notes to Unaudited Consolidated Financial Statements

   5

ITEM 2 - Management’s Discussion and Analysis of Financial Condition and Results of Operations

   10

ITEM 3 - Quantitative and Qualitative Disclosures About Market Risk

   17

ITEM 4 - Controls and Procedures

   17

PART II. OTHER INFORMATION

    

ITEM 4 – Submission of Matters to a Vote of Security Holders

   18

ITEM 6 - Exhibits and Reports on Form 8-K

   18

SIGNATURES

   20

 


Table of Contents

PART I - FINANCIAL INFORMATION

 

ITEM 1 – UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

 

GTC BIOTHERAPEUTICS, INC.

CONSOLIDATED BALANCE SHEETS

(Unaudited, dollars in thousands except share amounts)

 

    

July 4,

2004


    December 28,
2003


 
ASSETS                 

Current assets:

                

Cash and cash equivalents

   $ 13,701     $ 6,733  

Marketable securities

     20,656       24,358  

Accounts receivable and unbilled contract revenue

     1,033       1,613  

Deferred contract costs

     533       —    

Other current assets

     1,621       1,777  
    


 


Total current assets

     37,544       34,481  

Net property, plant and equipment

     21,903       22,600  

Net intangible assets

     10,576       11,094  

Inventory

     1,566       1,574  

Other assets

     1,316       1,323  

Restricted cash

     450       —    
    


 


Total assets

   $ 73,355     $ 71,072  
    


 


LIABILITIES AND SHAREHOLDERS’ EQUITY                 

Current liabilities:

                

Accounts payable

   $ 2,264     $ 2,340  

Accrued liabilities

     3,409       3,524  

Accrued liabilities - Genzyme

     3,302       1,924  

Deferred contract revenue

     1,059       323  

Current portion of long-term debt and capital leases

     2,221       2,218  

Note payable - Genzyme

     2,386       —    
    


 


Total current liabilities

     14,641       10,329  

Long-term debt and capital leases, net of current portion

     8,170       7,769  

Note payable – Genzyme

     2,387       4,773  

Deferred lease obligation

     31       40  
    


 


Total liabilities

     25,229       22,911  

Shareholders’ equity:

                

Preferred stock, $.01 par value; 5,000,000 shares authorized; no shares were issued and outstanding

     —         —    

Common stock, $.01 par value; 100,000,000 shares authorized; 41,520,253 and 34,749,473 shares issued and 38,700,253 and 31,929,473 shares outstanding at July 4, 2004 and December 28, 2003, respectively

     415       347  

Capital in excess of par value – common stock

     222,440       207,535  

Treasury stock, at cost, 2,820,000 shares

     (9,545 )     (9,545 )

Accumulated deficit

     (165,014 )     (150,179 )

Accumulated other comprehensive income

     (170 )     3  
    


 


Total shareholders’ equity

     48,126       48,161  
    


 


     $ 73,355     $ 71,072  
    


 


 

The accompanying notes are an integral part of these financial statements.

 

2


Table of Contents

GTC BIOTHERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited, dollars in thousands except per share amounts)

 

     Three months ended

    Six months ended

 
     July 4,
2004


    June 29,
2003


    July 4,
2004


    June 29,
2003


 

Revenues

                                

Revenue

   $ 1,416     $ 4,111     $ 2,463     $ 5,855  

Revenue from related party (Genzyme)

     23       —         42       —    
    


 


 


 


       1,439       4,111       2,505       5,855  

Costs of revenue and operating expenses:

                                

Cost of revenue

     1,491       3,293       2,563       6,869  

Research and development

     3,625       4,261       9,065       7,285  

Selling, general and administrative

     2,421       2,647       5,618       5,340  
    


 


 


 


       7,537       10,201       17,246       19,494  
    


 


 


 


Operating loss

     (6,098 )     (6,090 )     (14,741 )     (13,639 )

Other income (expense):

                                

Interest income

     125       215       108       507  

Interest expense

     (332 )     (133 )     (474 )     (269 )

Other income

     46       —         272       —    
    


 


 


 


Net loss

   $ (6,259 )   $ (6,008 )   $ (14,835 )   $ (13,401 )
    


 


 


 


Net loss per common share (basic and diluted)

   $ (0.16 )   $ (0.21 )   $ (0.41 )   $ (0.48 )
    


 


 


 


Weighted average number of common shares outstanding (basic and diluted)

     38,692       28,058       35,998       27,920  
    


 


 


 


Comprehensive loss:

                                

Net loss

   $ (6,259 )   $ (6,008 )   $ (14,835 )   $ (13,401 )

Other comprehensive income:

                                

Unrealized change in holding loss on securities available for sale

     (157 )     (58 )     (173 )     (93 )
    


 


 


 


Total other comprehensive loss

     (157 )     (58 )     (173 )     (93 )
    


 


 


 


Comprehensive loss

   $ (6,416 )   $ (6,066 )   $ (15,008 )   $ (13,494 )
    


 


 


 


 

The accompanying notes are an integral part of these financial statements.

 

3


Table of Contents

GTC BIOTHERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited, dollars in thousands)

 

     Six months ended

 
    

July 4,

2004


    June 29,
2003


 

Cash flows from operating activities:

                

Net loss

   $ (14,835 )   $ (13,401 )

Adjustments to reconcile net loss from continuing operations to net cash used in operating activities:

                

Depreciation and amortization

     1,977       1,516  

Stock based compensation

     475       —    

Amortization of premium (discount) on marketable securities

     1,098       (320 )

Non-cash common stock issuance to GTC savings and retirement plan

     309       172  

Inventory write-off

     8       —    

Changes in assets and liabilities:

                

Accounts receivable and unbilled contract revenue

     580       (1,665 )

Inventory

     —         (1,625 )

Deferred contract costs

     (533 )     —    

Other assets and liabilities

     154       718  

Accounts payable

     (76 )     (877 )

Accrued liabilities

     (115 )     (1,080 )

Accrued liabilities – Genzyme

     1,378       (973 )

Deferred contract revenue

     736       (1 )
    


 


Net cash used in operating activities

     (8,844 )     (17,536 )

Cash flows from investing activities:

                

Purchase of property, plant and equipment

     (762 )     (3,094 )

Purchase of marketable securities

     (14,804 )     (15,118 )

Redemption of marketable securities

     17,235       25,030  

Restricted cash

     (450 )     —    
    


 


Net cash provided by investing activities

     1,219       6,818  

Cash flows from financing activities:

                

Net proceeds from the issuance of common stock, net of offering costs

     13,868       —    

Net proceeds from long-term debt

     10,386       1,624  

Repayment of long-term debt

     (9,868 )     (760 )

Repayment of principal on capital leases

     (114 )     (169 )

Net proceeds from employee stock purchase plan

     210       363  

Net proceeds from the exercise of stock options

     111       —    
    


 


Net cash provided by financing activities

     14,593       1,058  
    


 


Net increase (decrease) in cash and cash equivalents

     6,968       (9,660 )

Cash and cash equivalents at beginning of period

     6,733       26,911  
    


 


Cash and cash equivalents at end of period

   $ 13,701