CORRECTING and REPLACING Regeneron Reports Second Quarter Financial and Operating Results.Business Editors/Health/Medical Writers CORRECTION...by Business Wire BIOWIRE2K TARRYTOWN, N.Y.--(BUSINESS WIRE)--Aug. 1, 2003 In BW5131 (NY-REGENERON) Regeneron Reports Second Quarter Financial and Operating Results, in the Condensed con·dense v. con·densed, con·dens·ing, con·dens·es v.tr. 1. To reduce the volume or compass of. 2. To make more concise; abridge or shorten. 3. Physics a. Statements of Operations (Unaudited), read the third and fourth columns xxx For the six months ended June 30, 2003 & 2002 (sted xxx For the three months ended). The corrected release reads: Regeneron Reports Second Quarter Financial and Operating Results Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced financial and operating results for the second quarter of 2003. Regeneron reported a net loss of $28.7 million, or $0.58 per share, for the second quarter of 2003 compared with a net loss of $30.4 million, or $0.69 per share, for the second quarter of 2002. The Company reported a net loss of $58.8 million, or $1.25 per share, for the six months ended June 30, 2003 compared with a net loss of $55.9 million, or $1.27 per share, for the same period in 2002. At June 30, 2003, cash, 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 , and restricted marketable securities totaled $283.4 million compared with $295.2 million at December 31, 2002. Regeneron's total revenue increased to $10.5 million in the second quarter of 2003 from $5.6 million in the same period of 2002. The Company's total revenue for the first six months of 2003 increased to $20.7 million from $10.5 million for the comparable period of 2002. The increase in contract research and development revenue resulted from the recognition of $7.0 million of revenue for the second quarter of 2003 and $13.7 million for the first six months of 2003 related to our IL-1 Trap collaboration with Novartis. The Company recognizes revenue in connection with the collaboration using the percentage of completion method in accordance with Staff Accounting Bulletin No. 101, Revenue Recognition in Financial Statements. Contract manufacturing revenue relates to Regeneron's long-term manufacturing agreement with Merck & Co., Inc. Contract manufacturing revenue decreased in both the second quarter and first half of 2003, compared with prior year periods, because product in inventory was not shipped to Merck during the first half of 2003. Shipments resumed in July 2003. The Company recognizes revenue and the related manufacturing expense as the product is shipped. 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. for the second quarter of 2003 were $37.5 million, 5 percent higher than the same period in 2002; and, for the first six months of 2003, they rose 16 percent from the prior year to $76.0 million. Research and development expenses increased 10 percent to $33.7 million for the second quarter of 2003 and 21 percent to $68.1 million for the first six months of 2003 compared with prior year periods. These increases were primarily due to expenses associated with the Company's development programs for the IL-1 Trap, which is in a Phase II trial for the treatment of 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. , AXOKINE(R), which is in Phase III clinical trials Noun 1. phase III clinical trial - 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 for the treatment of obesity, and VEGF VEGF vascular endothelial growth factor. Trap, which is in a Phase I trial for the treatment of cancer. General and administrative expenses increased in the current quarter and for the first six months of 2003 versus comparable periods in the prior year due primarily to increased administrative costs administrative costs, n.pl the overhead expenses incurred in the operation of a dental benefits program, excluding costs of dental services provided. required to support the Company's expanding development pipeline, higher insurance costs, and expenses for external service providers. Contract manufacturing expense decreased in both the second quarter and first half of 2003 compared with the same periods in 2002, because product in inventory was not shipped to Merck during the first half of 2003. Investment income declined in the current quarter and for the first six months of 2003 compared with prior year periods due to lower effective interest rates on investment securities and lower levels of interest-bearing investments. Interest expense, incurred primarily on $200.0 million of convertible notes issued in October 2001, declined slightly compared with last year's second quarter. The notes, which mature in 2008, bear interest at 5.5% per annum Per annum Yearly. . 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 quarter ended June 30, 2003, the weighted average number of shares outstanding increased to 49.6 million shares compared with 43.9 million shares in the same period last year, due primarily to the sale of 7.5 million shares of the Company's common stock to Novartis AG Novartis AG Swiss pharmaceutical company. It was formed through the 1996 merger of two Swiss firms: Ciba (see Ciba-Geigy) and Sandoz, a chemical company with interests in pharmaceuticals, nutrition, and agriculture. in 2003. Current Business Highlights Regeneron currently has four product candidates in clinical development. AXOKINE is in 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 trials for the treatment of obesity. The other three therapeutic candidates emerged from the Company's Trap program. These molecules have been designed to attach to (or "trap") specific cytokines Cytokines Chemicals made by the cells that act on other cells to stimulate or inhibit their function. Cytokines that stimulate growth are called "growth factors. and growth factors which, in excess, may cause destructive biological activity. The IL-1 Trap is in a Phase II trial for rheumatoid arthritis. The VEGF Trap is in a Phase I trial for cancer, and the IL-4/13 Trap is in a Phase I trial for asthma. Regeneron is currently completing a Phase II trial for the IL-1 Trap for the treatment of rheumatoid arthritis. The study involves approximately 200 subjects who have been randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. equally into placebo or one of 3 fixed-dose groups. Results from the 12 week efficacy phase of the trial are expected to be reported to be spoken of; to be mentioned, whether favorably or unfavorably. See also: Report in the second half of 2003. The Company has a Phase I trial underway with the VEGF Trap for cancer. A dose-escalation study, in which subjects receive a weekly, self-administered subcutaneous injection Noun 1. subcutaneous injection - an injection under the skin injection, shot - the act of putting a liquid into the body by means of a syringe; "the nurse gave him a flu shot" of the VEGF Trap, is currently in progress and an intravenous phase of this study is planned for later this year. This trial is designed 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 this therapeutic candidate in people with solid tumor tumor: see neoplasm. malignancies or with non-Hodgkin's lymphoma non-Hodg·kin's lymphoma n. Any of various malignant lymphomas characterized by the absence of Reed-Sternberg cells. Non-Hodgkin's lymphoma . A pre-clinical study published recently in The Proceedings of the National Academy of Sciences The Proceedings of the National Academy of Sciences of the United States of America, usually referred to as PNAS, is the official journal of the United States National Academy of Sciences. (PNAS PNAS Proceedings of the National Academy of Sciences PNAS Phosphate:Na + Symporter PNAS Pensacola Naval Air Station PNAS Philippine National Airsoft Society ) reported that Regeneron's VEGF Trap caused shrinkage of established, growing tumors and their metastases Metastasis (plural, metastases) A tumor growth or deposit that has spread via lymph or blood to an area of the body remote from the primary tumor. Mentioned in: Malignant Melanoma in a mouse model of anaplastic an·a·plas·tic adj. 1. Relating to the surgical restoration of a lost or absent part. 2. Of, relating to, or characterized by cells that have become less differentiated. anaplastic 1. Wilm's Tumor, a highly aggressive kidney tumor kidney tumor 1 Kidney cancer, see there 2 Wilms' tumor, see there . Regeneron is considering a number of strategies, including possible collaborative arrangements, to accelerate development of the VEGF Trap. Regeneron is also conducting a Phase I study of the IL-4/13 Trap in subjects with mild to moderate asthma. This trial is a placebo-controlled, double-blind, dose-escalation study to assess the safety and tolerability of the IL-4/13 Trap. About Regeneron Regeneron is a biopharmaceutical company that discovers, develops, and intends to commercialize therapeutic medicines for the treatment of serious medical conditions See carpal tunnel syndrome, computer vision syndrome, dry eyes and deep vein thrombosis. . Regeneron has therapeutic candidates in clinical trials for the potential treatment of obesity, rheumatoid arthritis, cancer, and asthma and has preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. programs in 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 pre-clinical and clinical development of therapeutic 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 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. 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, 2002 and the Form 10-Q Form 10-Q See 10-Q. for the quarter ended March 31, 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. Additional information about Regeneron and recent news releases are available on Regeneron's Worldwide Web Home Page at www.regn.com.
REGENERON PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS (Unaudited)
(In thousands, except per share data)
For the For the
three months six months
ended June 30, ended June 30,
2003 2002 2003 2002
--------- --------- --------- ---------
Revenues
Contract research and
development $9,774 $2,745 $19,198 $5,435
Contract manufacturing 758 2,824 1,470 5,075
--------- --------- --------- ---------
10,532 5,569 20,668 10,510
--------- --------- --------- ---------
Expenses
Research and development 33,717 30,701 68,107 56,178
Contract manufacturing 259 1,861 925 3,120
General and administrative 3,488 2,956 6,947 6,356
--------- --------- --------- ---------
37,464 35,518 75,979 65,654
--------- --------- --------- ---------
Loss from operations (26,932) (29,949) (55,311) (55,144)
--------- --------- --------- ---------
Other income (expense)
Investment income 1,101 2,553 2,309 5,325
Interest expense (2,905) (3,027) (5,844) (6,049)
--------- --------- --------- ---------
(1,804) (474) (3,535) (724)
--------- --------- --------- ---------
Net loss ($28,736) ($30,423) ($58,846) ($55,868)
========= ========= ========= =========
Net loss per share amounts,
basic and diluted ($0.58) ($0.69) ($1.25) ($1.27)
========= ========= ========= =========
Weighted average number of
Common and Class A shares
outstanding: basic and
diluted 49,566 43,914 46,937 43,868
========= ========= ========= =========
REGENERON PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS (Unaudited)
(In thousands)
June 30, December 31,
2003 2002
--------- ---------
ASSETS
Cash, marketable securities and restricted
marketable securities $283,378 $295,246
Receivables 7,871 4,017
Inventory 10,342 6,831
Property, plant and equipment, net 84,670 76,825
Other assets 9,286 8,655
--------- ---------
Total assets $395,547 $391,574
========= =========
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable and accrued expenses $14,043 $30,309
Deferred revenue 38,514 15,134
Notes payable 200,000 200,000
Other liabilities 5,147 150
Stockholders' equity 137,843 145,981
--------- ---------
Total liabilities and stockholders' equity $395,547 $391,574
========= =========
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