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Biotech / Medical : Regeneron Pharmaceuticals -- Ignore unavailable to you. Want to Upgrade?

To: Miljenko Zuanic who wrote (740)	1/30/2003 9:38:49 PM
From: mopgcw	Read Replies (1) \| Respond to of 3557

Regeneron Reports Fourth Quarter and Full Year 2002 Financial and Operating Results 1/30/2003 Tarrytown, New York (January 30, 2003) -- Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced financial and operating results for the fourth quarter and year ended December 31, 2002. Regeneron reported a net loss of $35.7 million, or $0.81 per share, for the fourth quarter of 2002 compared with a net loss of $28.4 million, or $0.65 per share, for the fourth quarter of 2001. The Company reported a net loss of $124.4 million, or $2.83 per share, for the full year 2002 compared with a net loss of $76.2 million, or $1.81 per share, in 2001. Cash, marketable securities, and restricted marketable securities totaled $295.2 million at December 31, 2002 compared with $438.4 million at December 31, 2001. Total operating expenses for the fourth quarter of 2002 were $39.5 million, 16 percent higher than the same period in 2001. For the full year 2002, these expenses were $143.9 million, an increase of 34 percent over the full year 2001. Research and development expenses increased 14 percent to $34.5 million for the fourth quarter of 2002 and 36 percent to $124.9 million for the full year 2002, primarily due to the expansion of the Company’s clinical development programs. The Company also continued to expand its basic research programs. Contract manufacturing expense relates primarily to Regeneron’s long-term manufacturing agreement with Merck & Co., Inc. Contract manufacturing expense increased to $1.7 million in the fourth quarter of 2002 from $1.2 million in the comparable quarter of 2001, primarily because Regeneron shipped more product to Merck in the fourth quarter of 2002. For the full years 2002 and 2001, the Company shipped similar amounts of product to Merck. Regeneron recognizes contract manufacturing revenue and the related manufacturing expense as the product is shipped. General and administrative expenses increased to $3.4 million in the current quarter from $2.7 million in last year’s fourth quarter. For the full year 2002, these expenses were $12.5 million, compared with $9.6 million in 2001. General and administrative expenses rose primarily due to higher staffing to support the growth of the Company and higher fees paid to outside service providers, including higher patent prosecution and legal expenses related to the expansion of the Company’s intellectual property portfolio. Interest expense increased in the fourth quarter of 2002 and for the full year 2002 compared with the same periods in 2001 due to interest incurred on $200.0 million of convertible notes issued in October 2001. The notes, which mature in 2008, bear interest at 5.5% per annum. Investment income declined for the full year 2002 compared with 2001 due to lower effective interest rates on investment securities and lower levels of interest-bearing investments in the fourth quarter of 2002, as the Company funded its operations. Regeneron’s total revenue increased to $4.9 million for the fourth quarter of 2002 from $4.4 million for the same period of 2001 because of higher contract manufacturing revenue as the Company shipped more product to Merck during the fourth quarter of 2002. Regeneron’s total revenue was $22.0 million for both the full year 2002 and 2001. Contract research and development revenue decreased for the full year 2002 due to the substantial completion of studies conducted on behalf of Amgen-Regeneron Partners. Contract manufacturing revenue increased for the full year 2002 primarily due to the receipt of a non-recurring $1.0 million payment related to the Company’s long-term manufacturing agreement with Merck. Per share amounts are based on the weighted average number of shares of the Company's Common Stock and Class A Stock outstanding. Current Business Highlights Regeneron’s clinical development program includes four product candidates. AXOKINE® is in Phase III trials for the treatment of obesity. In July 2001, Regeneron initiated a pivotal trial for AXOKINE in approximately 2,000 subjects that is being conducted in 65 sites across the United States. The Company recently announced the conclusion of the twelve-month treatment period of the pivotal trial, during which subjects received daily subcutaneous self-injections of placebo or AXOKINE. The data from this phase of the trial currently is being collected, and results are expected to be available around the beginning of the second quarter of 2003. This placebo-controlled, double-blind treatment phase is being followed by a twelve-month open-label safety extension phase, in which all study subjects receive AXOKINE. An additional trial began in June 2002 that will assess the safety and efficacy of AXOKINE in overweight individuals with type 2 diabetes mellitus. Two other trials, designed to evaluate the safety of intermittent treatment with AXOKINE and study maintenance of weight loss following short-term treatment regimens, were fully enrolled in July 2002 and are in progress. Additional twelve-month Phase III studies are expected to begin later in 2003. Regeneron recently announced that the U.S. Food and Drug Administration (FDA) had granted fast track designation to a component of the development program of AXOKINE obesity. This designation covers long-term treatment of seriously obese people who are unresponsive to, intolerant of, or unsuitable candidates for certain FDA approved medicines for obesity. As part of its ongoing development of AXOKINE, Regeneron plans to study the use of AXOKINE in this patient population. Regeneron has three additional product candidates in clinical development. The IL-1 Trap is being evaluated in a Phase II trial for safety and efficacy in people with active rheumatoid arthritis. This trial is enrolling approximately 200 subjects, who are being treated for 12 weeks and who will be evaluated for an additional 10 weeks after treatment ends. The VEGF Trap is in a Phase I clinical trial designed to assess the safety and tolerability of the molecule in subjects with solid tumor malignancies or with non-Hodgkins lymphoma. In the fourth quarter of 2002, Regeneron initiated a Phase I trial for 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. In other developments, the Company reported that it had entered into an agreement with Serono S.A. to use its proprietary Velocigene‰ technology platform to provide Serono with knock-out and transgenic mammalian models of gene function. Under the terms of the agreement, Serono will pay Regeneron up to $3 million annually for up to five years for models that target genes specified by Serono.