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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549


FORM 10-Q

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

For the quarterly period ended June 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 0-21794


GTC BIOTHERAPEUTICS, INC.
(Exact Name of Registrant as Specified in Its Charter)

Massachusetts
(State or Other Jurisdiction of
Incorporation or Organization)
  04-3186494
(I.R.S. Employer
Identification No.)

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

 

01702
(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 ý    No o

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

         Yes ý    No o

        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 July 30, 2003
Common Stock, $0.01 par value   28,247,887




GTC BIOTHERAPEUTICS, INC.
TABLE OF CONTENTS

 
  PAGE #
PART I. FINANCIAL INFORMATION    
 
ITEM 1—Financial Statements

 

 
 
Consolidated Balance Sheets as of June 29, 2003 and December 29, 2002

 

3
 
Consolidated Statements of Operations for the Three Months and Six Months Ended June 29, 2003 and June 30, 2002

 

4
 
Consolidated Statements of Cash Flows for the Six Months Ended June 29, 2003 and June 30, 2002

 

5
 
Notes to Unaudited Consolidated Financial Statements

 

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

 

14
 
ITEM 4—Controls and Procedures

 

14

PART II. OTHER INFORMATION

 

 
 
ITEM 4—Submission of Matters to Vote of Security Holders

 

15
 
ITEM 6—Exhibits and Reports on Form 8-K

 

16

SIGNATURES

 

17

2



PART I

ITEM 1—FINANCIAL STATEMENTS

GTC BIOTHERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(Unaudited, dollars in thousands except share amounts)

 
  June 29,
2003

  December 29,
2002

 
ASSETS              
Current assets:              
  Cash and cash equivalents   $ 17,251   $ 26,911  
  Marketable securities     20,753     30,438  
  Accounts receivable and unbilled contract revenue     3,844     2,179  
  Other current assets     1,159     1,932  
   
 
 
    Total current assets     43,007     61,460  
Net property, plant and equipment     23,667     21,701  
Net intangible assets     11,611     12,128  
Inventory     1,754      
Other assets     130     84  
   
 
 
    $ 80,169   $ 95,373  
   
 
 
LIABILITIES AND SHAREHOLDERS' EQUITY              
Current liabilities:              
  Accounts payable   $ 3,571   $ 4,448  
  Accounts payable—Genzyme Corporation     1,397     2,370  
  Accrued expenses     3,362     4,442  
  Deferred contract revenue     637     638  
  Current portion of long-term debt and capital leases     2,130     1,880  
   
 
 
    Total current liabilities     11,097     13,778  
Long-term debt and capital leases, net of current portion     13,231     12,786  
Deferred lease obligation     28     37  
   
 
 
    Total liabilities     24,356     26,601  

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; 31,067,887 and 30,579,064 shares issued and 28,247,887 and 27,759,064 shares outstanding at June 29, 2003 and December 29, 2002, respectively     311     306  
  Capital in excess of par value—common stock     198, 999     198,469  
  Treasury stock, at cost, 2,820,000 shares     (9,545 )   (9,545 )
  Accumulated deficit     (134,043 )   (120,642 )
  Accumulated other comprehensive income     91     184  
   
 
 
    Total shareholders' equity     55,813     68,772  
   
 
 
    $ 80,169   $ 95,373  
   
 
 

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

3


GTC BIOTHERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited, dollars in thousands except per share amounts)

 
  Three months ended
  Six months ended
 
 
  June 29,
2003

  June 30,
2002

  June 29,
2003

  June 30,
2002

 
Revenue   $ 4,111   $ 3,167   $ 5,855   $ 7,012  

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 
  Cost of revenue     3,293     3,924     6,869     8,230  
  Research and development     4,261     3,068     7,285     5,106  
  Selling, general and administrative     2,647     3,123     5,340     5,761  
   
 
 
 
 
      10,201     10,115     19,494     19,097  
   
 
 
 
 
Operating loss     (6,090 )   (6,948 )   (13,639 )   (12,085 )
Other income (expense):                          
  Interest income     215     559     507     1,179  
  Interest expense     (133 )   (104 )   (269 )   (153 )
   
 
 
 
 
Net loss   $ (6,008 ) $ (6,493 ) $ (13,401 ) $ (11,059 )
   
 
 
 
 
Net loss per common share (basic and diluted)   $ (0.21 ) $ (0.23 ) $ (0.48 ) $ (0.38 )
   
 
 
 
 
Weighted average number of common shares outstanding (basic and diluted)     28,058     27,916     27,920     29,072  
   
 
 
 
 
Comprehensive loss:                          
  Net loss   $ (6,008 ) $ (6,493 ) $ (13,401 ) $ (11,059 )
  Other comprehensive income:                          
    Unrealized change in holding gain (loss) on available for sale securities     (58 )   444     (93 )   (181 )
   
 
 
 
 
  Total other comprehensive income (loss)     (58 )   444     (93 )   (181 )
   
 
 
 
 
Comprehensive loss   $ (6,066 ) $ (6,049 ) $ (13,494 ) $ (11,240 )
   
 
 
 
 

The accompanying notes are an integral part of these financial statements

4


GTC BIOTHERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited, dollars in thousands)

 
  Six months ended
 
 
  June 29,
2003

  June 30,
2002

 
Cash flows from operating activities:              
  Net loss   $ (13,401 ) $ (11,059 )
  Adjustments to reconcile net loss from operations to net cash used in operating activities:              
    Depreciation and amortization     1,516     1,121  
    Amortization of premium/discount on marketable securities     (320 )   201  
    Non-cash common stock issuance to GTC savings and retirement plan     172     234  
    Provision for doubtful accounts         331  
    Loss on disposal of fixed assets         140  
  Changes in assets and liabilities:              
    Accounts receivable and unbilled contract revenue     (1,665 )   (1,531 )
    Inventory     (1,625 )    
    Other assets and liabilities     718     (1,580 )
    Accounts payable     (877 )   1,375  
    Accounts payable—Genzyme Corporation     (973 )   638  
    Accrued expenses     (1,080 )   (1,056 )
    Deferred contract revenue     (1 )   (1,493 )
   
 
 
    Net cash used in operating activities     (17,536 )   (12,679 )
Cash flows from investing activities:              
  Purchase of property, plant and equipment     (3,094 )   (2,658 )
  Purchase of marketable securities     (15,118 )   (34,609 )
  Redemption of marketable securities     25,030     47,297  
   
 
 
    Net cash provided by investing activities     6,818     10,030  
Cash flows from financing activities:              
  Proceeds from long-term debt     1,624     9,029  
  Repayment of long-term debt     (760 )   (6,065 )
  Repayment of principal on capital leases     (169 )   (89 )
  Acquisition of treasury stock from Genzyme Corporation         (4,773 )
  Net proceeds from employee stock purchase plan     363     293  
  Net proceeds from the exercise of stock options         3  
   
 
 
    Net cash provided by (used in) financing activities     1,058     (1,602 )
   
 
 
Net decrease in cash and cash equivalents     (9,660 )   (4,251 )
Cash and cash equivalents at beginning of period     26,911     26,850  
   
 
 
Cash and cash equivalents at end of period   $ 17,251   $ 22,599  
   
 
 

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

5



GTC BIOTHERAPEUTICS, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

1.
Basis of Presentation:
2.
Accounting Policies:

6


 
  Three Months Ended
  Six Months Ended
 
 
  June 29,
2003

  June 30,
2002

  June 29,
2003

  June 30,
2002

 
Net loss reported   $ (6,008 ) $ (6,493 ) $ (13,401 ) $ (11,059 )
Deduct: Total stock-based employee compensation expense determined under fair value based method for all awards, net of related tax effects     (605 )   (635 )   (1,378 )   (1,747 )
   
 
 
 
 
Pro Forma net loss   $ (6,613 ) $ (7,128 ) $ (14,779 ) $ (12,806 )
   
 
 
 
 
Earnings per share:                          
  Basic—as reported (basic and diluted)   $ (0.21 ) $ (0.23 ) $ (0.48 ) $ (0.38 )
  Basic—pro forma (basic and diluted)   $ (0.24 ) $ (0.26 ) $ (0.53 ) $ (0.44 )

7


3.
Intangible Assets:
 
  Amortization
Life

  June 29,
2003

  December 29,
2002

 
Asian marketing rights for SMIG   15 years   $ 11,210   $ 11,210  
Accumulated amortization—marketing rights         (2,117 )   (1,744 )
       
 
 
Net         9,093     9,466  
       
 
 
License agreement with ACT   10 years     1,862     1,862  
License agreement with Pharming   15 years     1,517     1,517  
Accumulated amortization—license agreements         (861 )   (717 )
       
 
 
Net         2,518     2,662  
       
 
 
Total intangible assets, net       $ 11,611   $ 12,128  
       
 
 
4.
New Accounting Pronouncements:

8


5.
Long-Term Debt:
6.
Taurus rhSA LLC:

9


7.
Malaria Vaccine Contract:
8.
Merrimack Pharmaceuticals, Inc. ("Merrimack"):
9.
Subsequent Event:

10



ITEM 2—MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS

RESULTS OF OPERATIONS

Three months ended June 29, 2003 and June 30, 2002

Total revenues for the three-month period ending June 29, 2003 were $4.1 million, compared with $3.2 million for the comparable period in 2002, an increase of $900,000 or 30%. The 2002 revenues included approximately $700,000 from Fresenius AG for the recombinant human serum albumin (rhSA) program. The rhSA program was structured into a joint venture in January 2003 which is consolidated for financial reporting purposes in the Company's financial statements. Excluding the 2002 revenues from the rhSA program, for comparison purposes, revenues were $2.5 million in the second quarter of 2002 compared to $4.1 million in the second quarter of 2003, an increase of $1.6 million, or 64%. The second quarter 2003 revenues are consistent with GTC's expectations for full year 2003 revenues of $15 million to $20 million because revenues are anticipated to increase in the second half of 2003 to the extent that GTC attracts partnering revenues in the rhATIII and rhSA programs and new external programs and obtains additional revenues from existing external programs, including the program with Merrimack Pharmaceuticals for clinical production of MM-093.

Operating expenses were $10.2 million in the current quarter, approximately flat with the $10.1 million recorded in the second quarter of 2002. GTC spent approximately $4.3 million on its internal research and development programs in the second quarter of 2003, an increase of approximately $1.2 million, or 39%, over the comparable 2002 quarter. The 2003 expenses include approximately $1.9 million to support the ongoing efficacy study for the rhATIII program and preparation for a filing for approval to market rhATIII in Europe to treat hereditary antithrombin deficiency (HD). Cost of revenue in the second quarter of 2003 was $3.3 million, compared with $3.9 million for the comparable period in 2002, a decrease of $600,000 or 16%. The decrease is due to the nature and timing of development activities on the Company's external programs.

Selling, general and administrative expenses (SG&A) decreased from $3.1 million in the second quarter of 2002 to $2.6 million in the corresponding quarter of 2003, a 15% decrease. The change in SG&A was the result of there being no increase in bad debt reserves in 2003, compared to a $331,000 increase in 2002, as well as a reduction of approximately $300,000 in legal expenses in 2003 compared to 2002, which were partially offset by increased expenses related to the acquisition of office and laboratory space of approximately $200,000 to consolidate several functions into a single location.

Interest income decreased to $215,000 in the second quarter of 2003, from $559,000 in the second quarter of 2002. The decrease was due to a lower cash balance and to the impact of lower interest rates in 2003.

Interest expense increased to $133,000 in the second quarter of 2003, from $104,000 in the second quarter of 2002 due to higher outstanding borrowings in 2003.

Six months ended June 29, 2003 and June 30, 2002

Total revenues for the six-month period ending June 29, 2003 were $5.9 million, compared with $7 million for the comparable period in 2002, a decrease of $1.2 million or 17%. The 2002 revenues included approximately $1.8 million from Fresenius AG for the rhSA program. The rhSA program was structured as a joint venture in January 2003. Excluding revenues from the rhSA program, for comparison purposes, revenues from the Company's external programs were $5.2 million in the first six months of 2002 compared with $5.9 million in the first six months of 2003, a 13% increase. The six-month 2003 revenues are consistent with GTC's expectations for full year 2003 revenues of $15 million to $20 million because revenues are anticipated to increase in the second half of 2003 to

11


the extent that GTC attracts partnering revenues in the rhATIII and rhSA programs and new external programs, and obtains additional revenues from existing external programs.

The cost of revenue and operating expenses were $19.5 million in the first six months of 2003, compared with $19.1 million for the comparable period in 2002, an increase of $400,000 or 2%. GTC spent approximately $7.3 million on internal research and development programs in the first six months of 2003, an increase of approximately $2.2 million over the first six months of 2002, or 43%. The 2003 expenses include approximately $3.2 million to support the ongoing efficacy study for the rhATIII program and preparation for a filing for approval to market rhATIII in Europe to treat HD. Cost of revenue for the first six months of 2003 was $6.9 million, compared with $8.2 million for the comparable period in 2002, a decrease of $1.4 million or 17%, which is in line with the decrease in revenues for the first six months of 2003.

SG&A decreased from $5.8 million in the first six months of 2002 to $5.3 million in the first six months of 2003, a 7% decrease. The change in SG&A was the result of there being no increase in bad debt reserves in 2003, compared to a $331,000 increase in 2002, as well as a reduction of approximately $400,000 in legal expenses in 2003 compared to 2002, which were partially offset by increased expenses related to the acquisition of office and laboratory space of approximately $200,000 to consolidate several functions into a single location.

Interest income decreased to $507,000 in the first six months of 2003, from $1.2 million in the first six months of 2002. The decrease was due to a lower cash balance and to the impact of lower interest rates in 2003.

Interest expense increased to $269,000 in the first six months of 2003, from $153,000 in the first six months of 2002 due to higher outstanding borrowings in 2003.

LIQUIDITY AND CAPITAL RESOURCES

GTC used approximately $19.3 million of cash in the first six months of 2003, bringing the balance of cash, cash equivalents and marketable securities to $38 million at June 29, 2003. This amount includes cash and cash equivalents of $17.3 million.

The principal sources of funds during the period included $1.6 million in proceeds from long-term debt, $9.9 million in net redemptions of marketable securities and $363,000 from the issuance of common stock under various employee stock plans. Uses of funds during the period included $17.5 million used in operations, of which $13.4 million was due to the Company's net loss, $1.6 million was for manufacturing of inventory for rhATIII, $1.7 million was due to an increase in accounts receivable and unbilled revenues, $3.1 million for capital equipment and further expansion of the transgenic production facility, of which $2.6 million was for manufacturing qualification runs for rhATIII and $929,000 for repayment of long-term debt and capital leases. The rhATIII production is a necessary part of the planned filing for approval in Europe.

GTC had working capital of $31.9 million at June 29, 2003 compared to $47.7 million at December 29, 2002.

On August 1, 2003, the Company issued and sold 3,626,465 shares of common stock at $2.55 per share in a private placement to institutional investors. The Company also issued warrants to the investors to purchase an aggregate of 906,613 shares of the Company's Common Stock at an exercise price of $3.30 per share. The Company paid SG Cowen a placement agent fee plus warrants to purchase 54,396 shares of the Company's Common Stock on the same terms as the placement warrants. Net proceeds to the Company, before other expenses, were approximately $8.6 million.

Management believes that existing cash resources plus proceeds from the August 1, 2003 private placement of common stock and warrants and partnering revenue opportunities will be sufficient to

12



fund operations into the second half of 2005. Revenue in 2003 is projected to be between $15 million and $20 million with a cash use of between $20 and $25 million exclusive of the August 2003 equity financing. The Company's forecasted revenue and cash use for 2003 is dependent upon attracting additional partnering revenues from existing and additional collaborations. Management projects that net operating cash use will decrease in the second half of 2003 based on anticipated partnering payments on the rhATIII and rhSA programs as well as payments for external programs, including the Merrimack program. Additionally, the Company incurred a significant portion of the costs on the Merrimack and ATIII development programs in the first half of 2003, including approximately $1.6 million for manufacturing inventory for rhATIII and $2.6 million for manufacturing qualification runs for rhATIII. Revenues from the Merrimack program as well as the collection of the Company's outstanding receivables for the Merrimack program are substantially dependent upon Merrimack completing further equity financing. Revenue recognized year-to-date under the Merrimack program during fiscal 2003 was approximately $2.8 million. Approximately $2.4 million was outstanding as a receivable/unbilled at June 29, 2003. The Company believes that collection of the outstanding receivable is reasonably assured; however, if Merrimack does not complete its financing, the Company may not be able to collect the full receivable balance. If the Company does not substantially achieve its revenue projections, the Company could be forced to delay, scale back or eliminate one or more of its research and development programs. In addition, from time to time, the Company may seek to raise additional funds from public or private sales of its securities, including equity securities. Should the Company need to raise additional financing in this manner, there can be no assurance that additional funding will be available on terms acceptable to the Company, if at all.

Management's current expectations regarding future revenues, development programs and the sufficiency of the Company's cash resources are forward-looking statements, and the Company's cash requirements may vary materially from such expectations. Such forward-looking statements are dependent on several factors, including the ability of the Company to enter into transgenic research and development collaborations in the future and the terms of such collaborations, the results of research and development and preclinical and clinical testing, competitive and technological advances and regulatory requirements.

CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT JUDGMENTS

In the Company's Form 10-K for the year ended December 29, 2002, the Company's most critical accounting policies and estimates upon which the Company's financial status depends were identified as those relating to revenue recognition, accrued liabilities, investments, intangible and long-lived assets and income taxes. The Company has reviewed the policies and determined that such policies remain the Company's most critical accounting policies for the quarter ended June 29, 2003. The Company did not make any changes to such policies during the quarter.

The Company established an inventory policy during 2003 under which the Company values inventories at cost or, if lower, fair value. The Company determines cost using the first-in, first-out method. The Company analyzes its inventory levels quarterly and will write down inventory that has become obsolete, inventory that has a cost basis in excess of its expected net realizable value and inventory in excess of expected requirements. Expired inventory will be disposed of and the related costs will be written off. If actual market conditions are less favorable than those projected by management, additional inventory write-downs may be required.

The Company capitalizes inventory produced for commercial sale, which may result in the capitalization of inventory that has not yet been approved for sale by regulatory authorities such as the FDA. If a product is not approved for sale, it would likely result in the write-off of the inventory and a charge to earnings. When and if capitalized inventory is used for research and development or clinical trials, it will be expensed accordingly at that time. At June 29, 2003, the Company's total inventories consisted of $1.8 million of finished goods inventory for products that have not yet been approved for sale.

13



COMMITMENTS AND CONTINGENCIES

In the Company's Form 10-K for the year ended December 29, 2002, the Company's commitments and contingencies were disclosed in the notes to the consolidated financial statements. The Company has reviewed the commitments and contingencies at June 29, 2003 and noted that there were no material changes or additions.

The Company is a party to license agreements for certain technologies. Certain of these agreements contain provisions for future royalties to be paid on commercial sales of products developed from the licensed technologies. Currently the amounts payable under these agreements and any resulting commitments on the Company's behalf are unknown and are not able to be estimated since the level of future sales, if any, is uncertain.


ITEM 3—QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

There have been no material changes in the Company's market risk since December 29, 2002. The Company's market risk disclosures are discussed in its Annual Report on Form 10-K under the heading Item 7A, Quantitative and Qualitative Disclosures About Market Risk.


ITEM 4—CONTROLS AND PROCEDURES

(a)
Evaluation of Disclosure Controls and Procedures

The Company's management, with the participation of its principal executive officer and principal financial officer, has evaluated the effectiveness of the design and operation of its disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities and Exchange Act of 1934, as amended, the "Exchange Act") as of the end of the period covered by this quarterly report. Based on this evaluation, the principal executive officer and principal financial officer concluded that the Company's disclosure controls and procedures are effective and designed to ensure that the information required to be disclosed in the reports filed or submitted by it under the Exchange Act is recorded, processed, summarized and reported within the requisite time periods.

(b)
Changes in Internal Control over Financial Reporting

There was no change in the Company's internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) identified in connection with the evaluation of the Company's internal control that occurred during its last fiscal quarter that has materially affected, or is reasonably likely to materially affect, its internal control over financial reporting.

14



PART II


ITEM 4—SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

        At the Annual Meeting of Stockholders held on May 21, 2003, the Company's stockholders voted as follows:

        To elect each of the following nominees to the Board of Directors for a three-year term.

Nominee

  Total Vote "FOR"
  Total Vote Withheld
Geoffrey F. Cox   24,259,662   156,950
Pamela W. McNamara   24,258,674   157,938
Marvin L. Miller   24,259,660   156,952

        To approve the Company's 2003 Employee Stock Purchase Plan

Total Vote "FOR"
  Total Vote "AGAINST"
  Total Vote "ABSTAIN"
23,972,176   376,946   67,490

15



ITEM 6—EXHIBITS AND REPORTS ON FORM 8-K


Exhibit
  Description

3.1.1   Restated Articles of Organization of the Company, filed with the Secretary of the Commonwealth of Massachusetts on December 27, 1993. Filed as Exhibit 3.1 to the Company's Annual Report on Form 10-K for the year ended December 31, 1993 (File No. 0-21794) and incorporated herein by reference.

3.1.2

 

Articles of Amendment to the Restated Articles of Organization filed with the Secretary of the Commonwealth of Massachusetts on October 3, 1994. Filed as Exhibit 3.1.2 to the Company's Annual Report on Form 10-K for the year ended December 28, 1997 (File No. 0-21794) and incorporated herein by reference.

3.1.3

 

Articles of Amendment to the Restated Articles of Organization filed with the Secretary of Commonwealth of Massachusetts on June 26, 1997. Filed as Exhibit 3 to the Company's Quarterly Report on Form 10-Q for the quarter ended June 29, 1997 (File No. 0-21794) and incorporated herein by reference.

3.1.4

 

Articles of Amendment to the Restated Articles of Organization of the Company filed with the Secretary of the Commonwealth of Massachusetts on June 1, 2000. Filed as Exhibit 4.1.5 to the Company's Registration Statement on Form S-8 filed with the Commission on June 2, 2000 (File No. 333-38490) and incorporated herein by reference.

3.1.5

 

Certificate of Vote of Directors Establishing a Series of a Class of Stock of GTC and designating the Series C Junior Participating Cumulative Preferred Stock. Filed as Exhibit 3.1 to the Company's Current Report on Form 8-K filed on June 1, 2001 (File No. 0-21794) and incorporated herein by reference.

3.1.6

 

Articles of Amendment to the Restated Articles of Organization of the Company filed with the Secretary of the Commonwealth of Massachusetts on May 31, 2002. Filed as Exhibit 3.1 to the Company's Current Report on Form 8-K filed on June 3, 2002 (File No. 0-21794) and incorporated herein by reference.

3.2

 

By-Laws of the Company, as amended. Filed as Exhibit 3.1 to the Company's Form 10-Q for the quarter ended July 4, 1999 (File No. 000-21794) and incorporated herein by reference.

10

 

Agreement Relating to the Production of Clarified Goat Milk Containing Recombinant Human Alpha Fetoprotein by and between the Company and Merrimack Pharmaceuticals, Inc., dated as of June 27, 2003. Filed herewith.*

31.1

 

Certification of Chief Executive Officer pursuant to Rule 13a-14(a). Filed herewith.

31.2

 

Certification of Chief Financial Officer pursuant to Rule 13a-14(a). Filed herewith.

32**

 

Certifications pursuant to 18 U.S.C. Section 1350. Filed herewith.



*

 

Certain confidential information contained in this document has been omitted and filed separately with the SEC pursuant to Rule 24b-2 promulgated under the Securities Exchange Act of 1934, as amended.

**

 

Indicates that the exhibit accompanies this report and is not filed as a part of it.

16



SIGNATURES

        Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: August 4, 2003   GTC BIOTHERAPEUTICS, INC.

 

 

By:

 

/s/
JOHN B. GREEN
John B. Green
Senior Vice President,
Chief Financial Officer and Treasurer
(Principal Financial and Accounting Officer)

17



EXHIBIT INDEX

Exhibit

  Description
10   Agreement Relating to the Production of Clarified Goat Milk Containing Recombinant Human Alpha Fetoprotein by and between the Company and Merrimack Pharmaceuticals, Inc., dated as of June 27, 2003. Filed herewith.*

31.1

 

Certification of Chief Executive Officer pursuant to Rule 13a-14(a). Filed herewith.

31.2

 

Certification of Chief Financial Officer pursuant to Rule 13a-14(a). Filed herewith.

32**

 

Certifications pursuant to 18 U.S.C. Section 1350.



*

 

Certain confidential information contained in this document has been omitted and filed separately with the SEC pursuant to Rule 24b-2 promulgated under the Securities Exchange Act of 1934, as amended.

**

 

Indicates that the exhibit accompanies this report and is not filed as a part of it.

        The following exhibits are incorporated herein by reference:

3.1.1   Restated Articles of Organization of the Company, filed with the Secretary of the Commonwealth of Massachusetts on December 27, 1993. Filed as Exhibit 3.1 to the Company's Annual Report on Form 10-K for the year ended December 31, 1993 (File No. 0-21794).

3.1.2

 

Articles of Amendment to the Restated Articles of Organization filed with the Secretary of the Commonwealth of Massachusetts on October 3, 1994. Filed as Exhibit 3.1.2 to Company's Annual Report on Form 10-K for the year ended December 28, 1997 (File No. 0-21794).

3.1.3

 

Articles of Amendment to the Restated Articles of Organization filed with the Secretary of Commonwealth of Massachusetts on June 26, 1997. Filed as Exhibit 3 to the Company's Quarterly Report on Form 10-Q for the quarter ended June 29, 1997 (File No. 0-21794).

3.1.4

 

Articles of Amendment to the Restated Articles of Organization of the Company filed with the Secretary of the Commonwealth of Massachusetts on June 1, 2000. Filed as Exhibit 4.1.5 to the Company's Registration Statement on Form S-8 filed with the Commission on June 2, 2000 (File No. 333-38490).

3.1.5

 

Certificate of Vote of Directors Establishing a Series of a Class of Stock of the Company and designating the Series C Junior Participating Cumulative Preferred Stock. Filed as Exhibit 3.1 to the Company's Current Report on Form 8-K filed on June 1, 2001 (File No. 0-21794).

3.1.6

 

Articles of Amendment to the Restated Articles of Organization of the Company filed with the Secretary of the Commonwealth of Massachusetts on May 31, 2002. Filed as Exhibit 3.1 to the Company's Current Report on Form 8-K filed on June 3, 2002 (File No. 0-21794).

3.2

 

By-Laws of the Company, as amended. Filed as Exhibit 3.1 to the Company's Form 10-Q for the quarter ended July 4, 1999 (File No. 000-21794) and incorporated herein by reference.



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GTC BIOTHERAPEUTICS, INC. TABLE OF CONTENTS
PART I
ITEM 1—FINANCIAL STATEMENTS
GTC BIOTHERAPEUTICS, INC. AND SUBSIDIARIES NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
ITEM 2—MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
PART II
SIGNATURES
EXHIBIT INDEX