SECURITIES AND EXCHANGE COMMISSION
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) |
Registrants telephone number, including area code | (914) 347-7000 | |||
NOT APPLICABLE
(Former name or former address, if changed since last report)
Page 1 of 8
Item 7. Financial Statements and Exhibits. | ||||||||
Item 9, Regulation FD Disclosure and Item 12, Disclosure of Operations and Financial Condition. | ||||||||
SIGNATURE | ||||||||
PRESS RELEASE |
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 companys 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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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 |
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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.
Regenerons total revenue increased to $21.3 million in the fourth quarter of 2003 from $4.9 million in the same period of 2002. The Companys 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 Regenerons 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 Companys 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 Companys 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 Companys 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 Companys 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 Regenerons 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.
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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 Regenerons 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 | |||||||||||||