Teva Provides Updated Outlook on 4th Quarter 2002 Earnings in Light of Amox/Clav ANDA Approval
2002-10-30 · Teva Branded Pharmaceutical Products R&D, Inc. · original tevapharm.com ↗
Jerusalem, Israel, October 30, 2002 - Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) provided new financial guidance in light of its receipt of U.S. Food and Drug Administration approval of its ANDA for Amoxicillin and Clavulanate Potassium Tablets, the generic version of GlaxoSmithKline's Augmentin® 875mg/125mg, and its anticipation of an imminent approval of the 500mg/125mg strength. While it is always difficult to predict pricing levels, as well as the timing of additional market entrants into this product, Teva is currently comfortable with projections of earnings per fully diluted share of $0.88 to $0.93 for the fourth quarter of 2002. Today's approval follows an earlier ruling by a federal judge, which invalidated seven GlaxoSmithKline patents related to this product. GlaxoSmithKline has appealed the decision. Mr. Israel Makov, President and CEO of Teva Pharmaceutical Industries, said: "We are currently in our launch preparations and expect to begin shipping the product shortly. This is a period of high seasonal demand for this important antibiotic, which has resulted in generic market shortages. Therefore, we look forward to the opportunity to make our generic version of Augmentin® available to the U. S. market." No guidance was given for fiscal 2003. Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 35 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. Over 80% of Teva's sales are in North America and Europe. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause Teva's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include Teva's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competitive generic products, the impact of competition from brand-name companies that sell their own generic products or successfully extend the exclusivity period of their branded products, Teva's ability to rapidly integrate the operations of acquired businesses, the availability of product liability coverage in the current insurance market, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration ("FDA") and other regulatory authority approvals, the regulatory environment and changes in the health policies and structure of various countries, acceptance and demand for new pharmaceutical products and new therapies, uncertainties regarding market acceptance of innovative products newly launched, currently being sold or in development, the impact of restructuring of clients, reliance on strategic alliances, exposure to product liability claims, dependence on patent and other protections for innovative products, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Teva's Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission ("SEC"). 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