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Biotech / Medical : SCIO Scios Inc. -- Ignore unavailable to you. Want to Upgrade?

To: Ian@SI who wrote (1392)	7/26/2001 3:40:37 PM
From: Linda Pearson	Read Replies (1) \| Respond to of 1477

<<Scios Inc. Reports 2001 Second Quarter Financial Results Natrecor FDA Pre-approval Inspection Completed Sales Force Ready to Launch SUNNYVALE, Calif., July 26 /PRNewswire/ -- Scios, Inc. (Nasdaq: SCIO) today announced financial results for the second quarter and six-month period ended June 30, 2001. Scios also updated investors on the progress made with the Company's lead product, Natrecor(R) (nesiritide). As previously announced, Scios has received an approvable letter from the U.S. Food and Drug Administration (FDA) for Natrecor, and Scios has been notified that the Natrecor New Drug Application has been recommended for approval by the San Francisco District Office of the FDA following their pre-approval inspection. "Our progress this quarter was among the most important in the company's history," said Richard B. Brewer, Scios' president and chief executive officer. "The FDA's Cardiovascular and Renal Drugs Advisory Committee unanimously recommended approval of Natrecor; the FDA issued an approvable letter for the drug; and the agency completed its pre-approval inspection. In addition, we raised more than $100 million, significantly strengthening our financial position and giving us the financial flexibility to launch and market Natrecor while developing our promising pipeline, most importantly our p38 kinase inhibitor for rheumatoid arthritis." The company announced that it is nearing completion of recruitment of a 170-person sales force to launch Natrecor in the third quarter of this year. To date, 153 Cardiovascular Specialists have been hired. Second Quarter and First Six-Month Financial Results. Net revenues for the second quarter were $5.2 million compared to $3.1 million in the same period last year. This increase was largely due to $2.1 million from the Company's sale of bulk Fibroblast Growth Factor ("FGF") to Kaken following the approval of Kaken's Fiblast(R) Spray in Japan. Total costs and expenses were $23.4 million in the second quarter compared to $13.1 million for the year ago period. The increase in costs and expenses for the quarter is primarily attributable to the costs associated with building a marketing and sales infrastructure for Natrecor commercialization. The company reported a net loss of $18.3 million, or $0.46 per diluted share, compared to a $10.3 million net loss, or $0.27 per diluted share, in last year's second quarter. Per share amounts were based on 40.1 million weighted average diluted shares in the 2001 second quarter compared to 37.8 million weighted average diluted shares in last year's second quarter. Cash, cash equivalents and marketable securities (both current and non-current) balances at June 30, 2001 increased to $164.2 million, an increase from the first quarter of $102.1 million as a result of the successful secondary offering. Net revenues for the first six months of 2001 were $17.2 million compared to $6.3 million in the same period last year. The increase was primarily due to the sale of bulk FGF to Kaken of $2.1 million, and a one-time gain from the sale of marketing rights to GlaxoSmithKline in the amount of $9.4 million related to the psychiatric sales and marketing division. Total costs and expenses in the six-month period were $39.3 million, compared to $25.8 million for the year ago period. The company reported a net loss of $22.5 million in the first six months of 2001, or $0.57 per diluted share, compared to a $19.8 million net loss, or $0.52 per diluted share in last year's first six months. Pipeline Update Scios also announced that the first patient was enrolled in Scios' recently announced collaborative clinical trial with Medtronic, Inc. (NYSE: MDT). The pilot clinical trial is designed to study the effects of Natrecor in combination with Medtronic's Chronicle(R) Implantable Hemodynamic Monitor (IHM). This first pilot clinical study is taking place at the Karolinska Institute in Stockholm, Sweden. Scios plans to begin a Phase II clinical trial for SCIO-469 in patients with Rheumatoid Arthritis (RA) in the fourth quarter of this year. The Phase II study will be a multi-center clinical study conducted in the United States following the submission of an Investigational New Drug ("IND") application to the U.S. Food and Drug Administration in the fourth quarter of this year. Today's Conference Call Details As previously announced, Scios will host its customary quarterly conference call today at 7:00 a.m. PT / 10:00 a.m. ET to discuss the results of the second quarter of 2001 and the company's outlook. The dial-in number is 800-474-8920. The call will also be broadcast live and archived on Scios' web site at sciosinc.com until August 3, 2001.>>