SEC Filing | Regeneron Pharmaceuticals Inc.

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1 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): January 25, 2001 Regeneron Pharmaceuticals, Inc. - -------------------------------------------------------------------------------- (Exact name of registrant as specified in its charter) New York 333-31764 133444607 --------------- ------------ ------------------ (State or other (Commission (IRS Employer jurisdiction of File Number) Identification No.) incorporation) 777 Old Saw Mill River Rd, Tarrytown NY, 10591-6707 - -------------------------------------------------------------------------------- (Address of principal executive offices) (Zip Code) 9143477000 - -------------------------------------------------------------------------------- (Registrant's telephone number, including area code)

2 Regeneron Pharmaceuticals, Inc. Current Report on Form 8-K Items 1-4. Not applicable. Item 5. Other Events. On January 25, 2001, the Registrant issued a press release announcing its operating results for the fourth quarter and year ended December 31, 2000. The press release is attached hereto as Exhibit 99.1. Item 6. Not Applicable. Item 7. Financial Statements and Exhibits. The following exhibits are furnished in accordance with the provisions of Item 601 of Regulation S-K: Exhibit No. Description ----------- ----------- 99.1 Press Release, dated January 25, 2001 Item 8. Not Applicable

3 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's duly authorized signatory. Dated: January 25, 2001 REGENERON PHARMACEUTICALS, INC. By: /s/ Murray A. Goldberg ---------------------------- Name: Murray A. Goldberg Title: Vice President, Finance & Administration, Chief Financial Officer, Treasurer and Assistant Secretary 3

4 EXHIBIT INDEX Exhibit No. Description - ----------- ----------- 99.1 Press Release, dated January 25, 2001. 4

1 [REGENERON LOGO] FOR IMMEDIATE RELEASE REGENERON ANNOUNCES OPERATING RESULTS Tarrytown, New York, January 25, 2001 -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced its full year and fourth quarter financial and operating results for 2000. Regeneron reported a net loss of $23.2 million, or $0.66 per share, for the year ended December 31, 2000, compared to a net loss of $23.1 million, or $0.74 per share, in 1999. Cash and marketable securities at December 31, 2000 were $154.4 million, compared to $93.6 million at December 31, 1999. Regeneron's total revenue in 2000 increased to $67.8 million from $39.7 million in 1999. The increase was due primarily to higher contract research and development revenue, research progress payments received in 2000, and higher contract manufacturing revenue. Contract research and development revenue increased from The Procter & Gamble Company in connection with its long-term collaboration agreement with the Company and from Amgen-Regeneron Partners related to increased clinical trial activity. Research progress payments received in 2000 totaled $6.2 million, including two non-recurring payments totaling $3.5 million from Procter & Gamble related to its long-term collaboration agreement and a $3.0 million payment (less $0.3 million of Japanese withholding tax) from Sumitomo Pharmaceuticals Co., Ltd. related to a drug development agreement. Contract manufacturing revenue increased from Merck & Co., Inc. in connection with a long-term agreement and from Sumitomo Pharmaceuticals. The Company's full year operating expenses in 2000 increased to $89.4 million from $62.8 million in 1999 due primarily to higher research and development expense and contract manufacturing expense. The increase in research and development expense related to higher staffing and increased activity in the Company's preclinical and clinical research programs. Contract manufacturing expense was higher due to costs associated with commercial production for Merck and Sumitomo Pharmaceuticals.

2 For the fourth quarter of 2000, Regeneron reported a net loss of $8.5 million, or $0.23 per share, compared to a net loss of $1.4 million, or $0.04 per share, in the fourth quarter of 1999. Regeneron's total revenue in the fourth quarter of 2000 increased to $21.7 million from $13.1 million in the same period of 1999 due primarily to higher contract manufacturing revenue from Merck and Sumitomo Pharmaceuticals. Total operating expenses increased to $30.1 million in the fourth quarter of 2000 from $14.5 million in the same period of 1999, due primarily to higher research and development expense and contract manufacturing expense. The increase in research and development expense related to higher staffing and increased activity in Regeneron's preclinical and clinical research programs. Contract manufacturing expense was higher due to costs associated with commercial production for Merck and Sumitomo Pharmaceuticals. During the fourth quarter of 2000, the Company adopted Staff Accounting Bulletin 101, REVENUE RECOGNITION IN FINANCIAL STATEMENTS, (SAB 101) effective as of January 1, 2000. The cumulative effect of adopting SAB 101 was to increase the Company's net loss by $1.6 million, or $0.04 per share, for the full year 2000. Per share amounts are based on the weighted average number of shares of the Company's Common Stock and Class A Stock outstanding. CLINICAL DEVELOPMENT UPDATE In November 2000, Regeneron reported preliminary results of a Phase II dose-ranging trial to study the safety and efficacy of AXOKINE(R) in severely obese patients. Patients treated with AXOKINE showed medically meaningful and statistically significant weight loss compared to those receiving placebo and the drug was generally well tolerated and was not associated with any reported serious adverse events. Pending discussions with the FDA, we intend to initiate Phase III testing of AXOKINE in mid-2001. In December 2000, Regeneron announced that it had initiated a Phase I clinical trial to assess the safety and tolerability of the Company's interleukin-1 (IL-1) Cytokine Trap in patients with rheumatoid arthritis. The placebo-controlled, double-blind, dose-escalation study is being conducted at several centers in the United States and includes a single dose phase and a multiple dose phase. Regeneron plans to place three new product

3 candidates into clinical trials in 2001, including its VEGF Trap for cancer and related disorders, IL-4/13 Trap for asthma/allergy related conditions, and pegylated AXOKINE for obesity. On January 25, 2001, Amgen-Regeneron Partners discontinued all clinical development of BDNF for the potential treatment of amyotrophic lateral sclerosis (ALS) following notification that BDNF did not provide a therapeutic advantage to ALS patients in clinical trials. Regeneron is a biopharmaceutical company that discovers, develops, and intends to commercialize therapeutic drugs for the treatment of serious medical conditions. Regeneron's platform technologies include Targeted Genomics(TM), Functionomics(TM), and Designer Protein Therapeutics(TM). Regeneron has drugs in clinical trials for the potential treatment of obesity and rheumatoid arthritis, and has preclinical development programs in cancer, asthma, allergies, and other diseases and disorders. THIS NEWS RELEASE DISCUSSES HISTORICAL INFORMATION AND INCLUDES FORWARD-LOOKING STATEMENTS ABOUT REGENERON AND ABOUT 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 CURRENT FORM 10-Q AND ITS FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 1999. REGENERON DOES NOT UNDERTAKE ANY OBLIGATION TO UPDATE PUBLICLY ANY FORWARD-LOOKING STATEMENT, WHETHER AS A RESULT OF NEW INFORMATION, FUTURE EVENTS, OR OTHERWISE. ### Contact: Murray A. Goldberg, Senior Vice President Finance and Administration and CFO Regeneron Pharmaceuticals, Inc. (914) 345-7492

4 REGENERON PHARMACEUTICALS, INC. CONDENSED BALANCE SHEETS (UNAUDITED) (IN THOUSANDS) DECEMBER 31, DECEMBER 31, 2000 1999 ------------ ----------- ASSETS Cash and marketable securities $154,370 $93,599 Receivable due from The Procter & Gamble Company 6,907 Inventory 1,915 4,552 Property, plant and equipment, net 36,934 36,298 Other assets 8,148 2,550 -------- -------- Total assets $208,274 $136,999 ======== ======== LIABILITIES AND STOCKHOLDERS' EQUITY Accounts payable and accrued expenses $9,402 $6,551 Deferred revenue 13,723 15,816 Capital lease obligations 1,148 2,584 Other 1,827 2,516 liabilities Stockholders' equity 182,130 109,532 -------- -------- Total liabilities and stockholders' $208,230 $136,999 equity ======== ========

5 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, 2000 1999 2000 1999 ---------- --------- ---------- ---------- Revenues Contract research and development $9,156 $9,228 $36,478 $24,539 Research progress payments 6,200 Contract manufacturing 9,981 2,661 16,598 9,960 Investment income 2,513 1,193 8,480 5,207 -------- -------- -------- -------- 21,650 13,082 67,756 39,706 -------- -------- -------- -------- Expenses Research and development 15,786 9,977 56,256 44,940 Loss in Amgen-Regeneron Partners 1,125 1,650 4,575 4,159 General and administrative 3,106 1,664 8,309 6,355 Depreciation and amortization 1,296 974 4,421 3,426 Contract manufacturing 8,738 160 15,566 3,612 Interest 54 39 281 284 -------- -------- -------- -------- 30,105 14,464 89,408 62,776 -------- -------- -------- -------- Net loss before cumulative effect of a change in accounting principle (8,455) (1,382) (21,652) (23,070) Cumulative effect of adopting Staff Accounting Bulletin 101 ("SAB 101") (1,563) -------- -------- -------- -------- Net loss ($8,455) ($1,382) ($23,215) ($23,070) ======== ======== ======== ======== Net loss per share, basic and diluted: Net loss before cumulative effect of a change in accounting principle ($0.23) ($0.04) ($0.62) ($0.74) Cumulative effect of adopting SAB 101 (0.04) -------- -------- -------- -------- Net loss per share ($0.23) ($0.04) ($0.66) ($0.74) ======== ======== ======== ======== Weighted average number of Common and Class A shares outstanding, basic and diluted 36,767 31,341 34,950 31,308 ======== ======== ======== ========