Regeneron Announces First Quarter 2001 Results.Business Editors TARRYTOWN, N.Y.--(BUSINESS WIRE)--May 1, 2001 Regeneron Pharmaceuticals, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : REGN) today announced its financial and operating results for the first quarter of 2001. Regeneron reported a net loss of $13.0 million, or $0.35 per share, for the first quarter of 2001, compared to a net loss of $8.8 million, or $0.28 per share, for the first quarter of 2000. Cash and marketable securities Marketable Securities Very liquid securities that can be converted into cash quickly at a reasonable price. Notes: Marketable securities are very liquid as they tend to have maturities less than one year, and the rate at which these securities can be bought or sold has at March 31, 2001 were $299.2 million, compared to $154.4 million at December 31, 2000. Regeneron's total revenue decreased to $6.3 million in the first quarter of 2001 from $10.6 million in the same period of 2000. The decrease was due to lower contract research and development revenue from The Procter & Gamble Company in connection with a long-term collaboration agreement and from Amgen-Regeneron Partners due to the cessation cessation Vox populi The stopping of a thing. See Smoking cessation. of clinical trial activity on brain-derived neurotrophic factor Brain-derived neurotrophic factor (BDNF) is a neurotrophic factor found in the brain and the periphery. It is a protein that acts on certain neurons of the central nervous system and the peripheral nervous system that helps to support the survival of existing neurons and encourage (BDNF BDNF Brain-Derived Neurotrophic Factor BDNF Beaverhead-Deerlodge National Forest (Montana) ) in January 2001. Contract manufacturing revenue related to a long-term manufacturing agreement with Merck & Co., Inc. increased in the first quarter of 2001 compared to the first quarter of 2000. Total operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. increased to $21.0 million in the first quarter of 2001 from $17.7 million in the same period of 2000. The increase was due primarily to higher research and development expense as a result of added staffing and increased activity in Regeneron's preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. and clinical research programs. Contract manufacturing expense decreased in the first quarter of 2001 relative to the same period last year, since the Company incurred higher costs in the first quarter of 2000 associated with initiating commercial production under its contract manufacturing agreements. The Company adopted Staff Accounting Bulletin 101, Revenue Recognition in Financial Statements, (SAB SAB Spontaneous abortion. See Abortion. 101) effective January 1, 2000. The cumulative effect of adopting SAB 101 was to increase the Company's net loss by $1.6 million, or $0.05 per share, for the first quarter of 2000. In March and April 2001, Regeneron sold 6.63 million shares of Common Stock in a public offering at a price of $25.00 per share for proceeds to the Company of $156.8 million, after commissions and estimated expenses. 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 o·bese adj. Extremely fat; very overweight. obese characterized by obesity. obese adjective Characterized by obesity, see there; excessively fat 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 not associated with any reported serious adverse events. In February 2001, Regeneron reported that preliminary analysis of interim data indicated that patients treated with AXOKINE maintained their average weight loss relative to patients who received placebo three months following their last treatment with AXOKINE. In April 2001, Regeneron began end-of-Phase II discussions with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. . Regeneron plans to initiate Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA testing of AXOKINE in mid-2001 in several thousand patients. In December 2000, Regeneron announced that it had initiated a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I to assess the safety and tolerability tol·er·a·ble adj. 1. Capable of being tolerated; endurable. 2. Fairly good; passable. See Synonyms at average. tol of the Company's interleukin-1 (IL-1) Cytokine Cytokine Any of a group of soluble proteins that are released by a cell to send messages which are delivered to the same cell (autocrine), an adjacent cell (paracrine), or a distant cell (endocrine). Trap in patients with rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. . The placebo-controlled, double-blind, dose-escalation study is being conducted at several center in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . Single dose and multiple dose phases are both currently underway, and results of the trial are expected in the second half of 2001. Later this year, Regeneron plans to initiate Phase I clinical trials of three product candidates: the VEGF VEGF vascular endothelial growth factor. Trap for harmful angiogenesis angiogenesis /an·gio·gen·e·sis/ (-jen´e-sis) vasculogenesis; development of blood vessels either in the embryo or in the form of neovascularization or revascularization. an·gi·o·gen·e·sis n. or vascular leak, the IL-4/13 Cytokine Trap for asthma, and pegylated AXOKINE for obesity. Regeneron is a biopharmaceutical company that discovers, develops, and intends to commercialize therapeutic drugs for the treatment of serious medical conditions See carpal tunnel syndrome, computer vision syndrome, dry eyes and deep vein thrombosis. . Regeneron's platform technologies include Targeted Genomics(TM), Functionomics(TM), and Designer Protein Therapeutics therapeutics Treatment and care to combat disease or alleviate pain or injury. Its tools include drugs, surgery, radiation therapy, mechanical devices, diet, and psychiatry. (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 Allergies Definition Allergies are abnormal reactions of the immune system that occur in response to otherwise harmless substances. Description Allergies are among the most common of medical disorders. , and other diseases and disorders. This news release discusses historical information and includes forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 2000. 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. Additional information about Regeneron and recent news releases are available on Regeneron's Worldwide Web Home Page at www.regeneron.com. Fax copies of news releases can be obtained from Regeneron's News-on-Demand Service by dialing (800) 311-0841.
REGENERON PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS (Unaudited)
(In thousands)
March 31, December 31,
2001 2000
--------- ------------
ASSETS
Cash and marketable securities $299,213 $154,370
Receivables 8,608 13,835
Property, plant and equipment, net 37,166 36,934
Other assets 4,198 3,135
-------- --------
Total assets $349,185 $208,274
======== ========
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable and accrued expenses $9,404 $9,446
Deferred revenue 12,395 13,723
Other liabilities 2,975 2,975
Stockholders' equity 324,411 182,130
-------- --------
Total liabilities and stockholders' equity $349,185 $208,274
======== ========
REGENERON PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS (Unaudited)
(In thousands, except per share data)
For the three months
ended March 31,
2001 2000
------ ------
Revenues
Contract research and development $3,414 $9,215
Contract manufacturing 2,899 1,376
------- -------
6,313 10,591
------- -------
Expenses
Research and development 16,805 12,876
Contract manufacturing 2,188 3,051
General and administrative 2,031 1,780
------- ------
21,024 17,707
------- ------
Loss from operations (14,711) (7,116)
------- ------
Other income (expense)
Investment income 2,772 1,226
Loss in Amgen-Regeneron Partners (1,051) (1,271)
Interest expense (47) (64)
------- ------
1,674 (109)
------- ------
Net loss before cumulative effect
of a change in accounting principle (13,037) (7,225)
Cumulative effect of adopting Staff
Accounting Bulletin 101 ("SAB 101") (1,563)
------- ------
Net loss ($13,037) ($8,788)
======= ======
Net loss per share amounts, basic and diluted:
Net loss before cumulative effect
of a change in accounting principle ($0.35) ($0.23)
Cumulative effect of adopting SAB 101 (0.05)
------- ------
Net loss ($0.35) ($0.28)
======= ======
Weighted average number of Common and Class
A shares outstanding: basic and diluted 37,472 31,927
======= ======
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