REGERERON PHARMACEUTICALS, INC.
Table of Contents

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549


FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

     
Date of Report (Date of earliest event reported)   February 24, 2004 (February 23, 2004)
   
     
REGENERON PHARMACEUTICALS, INC

(Exact name of registrant as specified in its charter)
         
NEW YORK   0-19034   No. 13-3444607

(State or other jurisdiction
of incorporation)
  (Commission
File Number)
  (IRS Employer
Identification No.)
     
777 OLD SAW MILL RIVER ROAD, TARRYTOWN, NY    10591-6707

(Address of principal executive offices)   (Zip Code)
         
    Registrant’s telephone number, including area code   (914) 347-7000
       

NOT APPLICABLE
(Former name or former address, if changed since last report)

Page 1 of 8

 


TABLE OF CONTENTS

Item 7. Financial Statements and Exhibits.
Item 9, Regulation FD Disclosure and Item 12, Disclosure of Operations and Financial Condition.
SIGNATURE
PRESS RELEASE


Table of Contents

INFORMATION TO BE INCLUDED IN REPORT

Item 7. Financial Statements and Exhibits.

  (c)   Exhibits

    99(a) Press Release dated February 23, 2004.

Item 9, Regulation FD Disclosure and Item 12, Disclosure of Operations and Financial Condition.

          The following information is furnished pursuant to “Item 9. Regulation FD Disclosure” and “Item 12. Disclosure of Results of Operations and Financial Condition.” On Monday, February 23, 2004, Regeneron Pharmaceuticals, Inc. issued a press release to report the company’s financial results for the fiscal quarter and year ended December 31, 2003. A copy of the press release is attached hereto as Exhibit 99(a).

          The information included in this Current Report on Form 8-K shall not be deemed “filed” for purposes of, nor shall it be deemed incorporated by reference in, any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934, except as expressly set forth by specific reference in such a filing.

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Table of Contents

SIGNATURE

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 thereunto duly authorized.

     
    Regeneron Pharmaceuticals, Inc.
     
    By: /s/ Stuart Kolinski
     
    Stuart Kolinski
Vice President & General Counsel
Date: February 24, 2004    

-3-

PRESS RELEASE
 

Exhibit 99(a)

FOR IMMEDIATE RELEASE

REGENERON REPORTS FOURTH QUARTER AND FULL YEAR 2003 FINANCIAL AND OPERATING
RESULTS

Tarrytown, New York (February 23, 2004) — Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced financial and operating results for the fourth quarter and year ended December 31, 2003.

Regeneron reported a net loss of $19.4 million, or $0.35 per share, for the fourth quarter of 2003 compared with a net loss of $35.7 million, or $0.81 per share, for the fourth quarter of 2002. The Company reported a net loss of $107.5 million, or $2.13 per share, for the full year 2003 compared with a net loss of $124.4 million, or $2.83 per share, in 2002.

At December 31, 2003, cash, marketable securities, and restricted marketable securities totaled $366.6 million compared with $295.2 million at December 31, 2002.

Regeneron’s total revenue increased to $21.3 million in the fourth quarter of 2003 from $4.9 million in the same period of 2002. The Company’s total revenue for the full year 2003 increased to $57.5 million from $22.0 million in 2002. The increase in revenue is attributable to higher contract research and development revenue resulting from the recognition of $16.0 million of revenue for the fourth quarter of 2003 and $35.7 million for the full year 2003 related to both our collaboration with Aventis Pharmaceuticals Inc. on the VEGF Trap, which began in the third quarter of 2003, and our collaboration with Novartis Pharma AG on the IL-1 Trap, which began in the first quarter of 2003. The Company recognizes revenue in connection with these collaborations in accordance with Staff Accounting Bulletin No. 101, Revenue Recognition in Financial Statements. As a result, $98.5 million of non-refundable payments received as of December 31, 2003 in connection with the Aventis and Novartis collaborations has been deferred and will be recognized as revenue in future periods.

Contract manufacturing revenue relates to Regeneron’s long-term manufacturing agreement with Merck & Co., Inc. The Company recognizes revenue and the related manufacturing expense as product is shipped to Merck. Contract manufacturing revenue was $2.2 million in both the fourth quarter of 2003 and 2002. Contract manufacturing

 


 

revenue decreased to $10.1 million for the full year 2003 from $11.1 million in 2002, due primarily to receipt of a non-recurring $1.0 million payment from Merck in the third quarter of 2002.

Total operating expenses for the fourth quarter of 2003 were $38.4 million, 3 percent lower than the same period in 2002. For the full year 2003, total operating expenses rose 9 percent from the prior year to $157.5 million. Research and development (R&D) expenses decreased to $33.3 million in the fourth quarter of 2003 from $34.5 million in the comparable quarter of 2002, primarily due to a decline in development expenses for the Company’s AXOKINE® program, partially offset by increased development expenses for the VEGF Trap. For the full year 2003, R&D expenses increased 9 percent to $136.0 million compared with 2002, primarily due to higher expenses for the VEGF Trap and IL-1 Trap development programs.

Contract manufacturing expense, which relates to the Merck agreement, decreased to $0.9 million in the fourth quarter of 2003 from $1.7 million in the comparable quarter of 2002, primarily because of reduced product inventory reserves. Contract manufacturing expense for the full year 2003 increased slightly to $6.7 million from $6.5 million in 2002. General and administrative expenses increased to $4.2 million in the fourth quarter of 2003 from $3.4 million in the comparable quarter of 2002, and $14.8 million for the full year 2003 from $12.5 million in 2002, primarily due to increased administrative costs required to support the Company’s expanding development pipeline, higher insurance costs, and expenses for external service providers.

Investment income declined in the fourth quarter and for the full year 2003 compared with prior year periods due to lower effective interest rates on investment securities and lower levels of interest-bearing investments in the first three quarters of 2003. Interest expense increased slightly in the fourth quarter and full year 2003 compared with the same periods in 2002. Interest expense is attributable primarily to $200.0 million of convertible notes issued in October 2001, which mature in 2008 and bear interest at 5.5% per annum.

Per share amounts are based on the weighted average number of shares of the Company’s Common Stock and Class A Stock outstanding. For the year ended December 31, 2003, the weighted average number of shares outstanding increased to 50.5 million shares compared with 43.9 million shares in the same period last year, due primarily to the sale of 7.5 million and 2.8 million shares of the Company’s common stock to Novartis and Aventis, respectively, in 2003.

About Regeneron

Regeneron is a biopharmaceutical company that discovers, develops, and intends to commercialize therapeutic medicines for the treatment of serious medical conditions. Regeneron has therapeutic

 


 

candidates in clinical trials for the potential treatment of cancer, rheumatoid arthritis, obesity, and asthma and has preclinical programs in other diseases and disorders.

This news release discusses historical information and includes forward-looking statements about Regeneron and its products, programs, finances, and business, all of which involve a number of risks and uncertainties, such as risks associated with preclinical and clinical development of drugs and biologics, determinations by regulatory and administrative governmental authorities, competitive factors, technological developments, the availability and cost of capital, the costs of developing, producing, and selling products, the potential for any collaboration agreement to be canceled or to terminate without any product success, and other material risks. A more complete description of these risks can be found in Regeneron’s filings with the United States Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2002 and the Form 10-Q for the quarter ended September 30, 2003. Regeneron does not undertake any obligation to update publicly any forward-looking statement, whether as a result of new information, future events, or otherwise unless required by law.

###

     
Contacts:    
Charles Poole   Lauren Tortorete
Vice President, Investor Relations   Biosector2
charles.poole@regeneron.com   ltortorete@biosector2.com
(914) 345-7640   (212) 845-5609

Additional information about Regeneron and recent news releases are available on Regeneron’s Worldwide Web Home Page at www.regeneron.com

 


 

REGENERON PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS (Unaudited)

(In thousands)

                   
      December 31,
     
      2003   2002
     
 
ASSETS
               
Cash, marketable securities and restricted marketable securities
  $ 366,566     $ 295,246  
Receivables
    15,529       4,017  
Inventory
    9,006       6,831  
Property, plant and equipment, net
    80,723       76,825  
Other assets
    7,731       8,655  
 
   
     
 
 
Total assets
  $ 479,555     $ 391,574  
 
   
     
 
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
Accounts payable and accrued expenses
  $ 18,933     $ 30,309  
Deferred revenue
    109,003       15,134  
Notes payable
    200,000       200,000  
Other liabilities
    13,976       150  
Stockholders’ equity
    137,643       145,981  
 
   
     
 
 
Total liabilities and stockholders’ equity
  $ 479,555     $ 391,574  
 
   
     
 

 


 

REGENERON PHARMACEUTICALS, INC.

CONDENSED STATEMENTS OF OPERATIONS (Unaudited)
(In thousands, except per share data)

                                   
      For the three months   For the year
      ended December 31,   ended December 31,
     
 
      2003   2002   2003   2002
     
 
 
 
Revenues
                               
 
Contract research and development
  $ 19,121     $ 2,709     $ 47,366     $ 10,924  
 
Contract manufacturing
    2,151       2,203       10,131       11,064  
 
   
     
     
     
 
 
    21,272       4,912       57,497       21,988  
 
   
     
     
     
 
Expenses
                               
 
Research and development
    33,267       34,480       136,024       124,953  
 
Contract manufacturing
    907       1,726       6,676       6,483  
 
General and administrative
    4,237       3,365       14,785       12,532  
 
   
     
     
     
 
 
    38,411       39,571       157,485       143,968  
 
   
     
     
     
 
Loss from operations
    (17,139 )     (34,659 )     (99,988 )     (121,980 )
 
   
     
     
     
 
Other income (expense)
                               
 
Investment income
    868       1,759       4,462       9,462  
 
Interest expense
    (3,106 )     (2,793 )     (11,932 )     (11,859 )
 
   
     
     
     
 
 
    (2,238 )     (1,034 )     (7,470 )     (2,397 )
 
   
     
     
     
 
Net loss
    ($19,377 )     ($35,693 )     ($107,458 )     ($124,377 )
 
   
     
     
     
 
Net loss per share amounts, basic and diluted
    ($0.35 )     ($0.81 )     ($2.13 )     ($2.83 )
 
   
     
     
     
 
Weighted average number of Common and Class A shares outstanding: basic and diluted
    55,183       43,984       50,490       43,918