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Executive Summary

Syntex has entered into a supply agreement with Wyeth-Ayerst for use of its Tubex closed injection system to deliver Syntex' pre-filled injectable nonsteroidal anti-inflammatory drug Toradol (ketorolac), Syntex said in announcing of its first quarter results Nov. 25. Pending FDA approval, the new supply agreement should alleviate shortages of the drug, Syntex said. Sales in the U.S. "have been limited by a shortage of syringe-filling capacity over the past three quarters," Syntex noted. The company will continue to use Catrix syringes provided by Survival Technology, Inc. in addition to Tubex. Syntex noted that it is working on an oral form of Toradol. Despite the supply problems, sales of ketorolac increased 79% to $ 24 mil. for Syntex' fiscal 1992 first quarter (ended Oct. 31). A 13% increase in sales of Syntex' flagship NSAIDs Naprosyn (naproxen) and Anaprox (naproxen sodium) spurred a like increase of 13% in the company's total human pharmaceutical sales for the quarter. Naprosyn/Anaprox sales increased to $ 266 mil., and Syntex' total pharmaceutical business generated $ 437 mil. for the quarter. Syntex U.S. drug sales rose 19% to $ 318 mil. for the quarter. The Naprosyn franchise showed a 23% sales increase, to $ 208 mil. in the U.S. Results include $ 8.8 mil. in Medicaid rebates, Syntex noted. Non-U.S. sales of Naprosyn/Anaprox declined 11% to $ 58 mil., and total non-U.S. sales were unchanged at $ 119 mil. Syntex Chairman Paul Freiman blamed the non-U.S. sales decrease on "new competition in various markets, the negative impact of currency fluctuations and price decreases." During the quarter, Syntex entered into a consent decree on Oct. 10 mandating a series of corrective actions for Naprosyn promotions that made arthroprotective claims ("The Pink Sheet" Oct. 14, p. 6). Syntex' four newer products, Toradol, Cardene (nicardipine), Cytovene (ganciclovir) and Synarel (nafarelin acetate), contributed a combined $ 69 mil. for the quarter, a 30% increase over last year, Syntex said. Cardene sales increased 11% to $ 21 mil., while Synarel sales declined 26% to $ 7.2 mil. Cytovene sales increased 48% to $ 17.3 mil. in the quarter, but it is too early to tell what impact the approval of Astra's competing product Foscavir with its improved survival statistics will have on Cytovene revenues. On Oct. 21, the National Eye Institute announced that results of a trial comparing Cytovene and Foscavir (foscarnet) showed a survival improvement among Foscavir patients and suggested that foscarnet for AIDS patients may be the preferrable initial treatment ("The Pink Sheet" Oct. 28, T&G-8). However, the cost of Foscavir, estimated at $ 22,000 annually, is significantly higher than a year's therapy with Cytovene, and Cytovene was better for CMV patients with impaired renal function. Syntex has increased its marketing and research expenses, Freiman noted. "These expenditures include preparations for new product introductions and the development of new systems and processes to bring potential new products through our research and development pipeline more quickly. Such activities are key elements of our strategic plan to bring new products to the market in a timely way in light of the December 1993 expiration of the U.S. patent for Naprosyn." Syntex is gearing up to launch Ticlid (ticlopidine), approved Oct. 31 as a stroke prevention agent. "Initial shipments of Ticlid will occur in December," Freiman said. He noted that Syntex has 11 other NDAs pending. Selling, general and administrative expenses for the quarter increased 21% to $ 185 mil., Syntex said. The company has added 166 representatives to its U.S. sales force since the first quarter of FY. 1991. Research expenses for the quarter rose 19%, to $ 85.2 mil. The company said it expects to spend approximately $ 370 mil. on R&D in FY 1992, a 17% increase over the last 12-month period. The increased expenditures will create "a different pattern of quarter-to-quarter profitability than in the past few years," Freiman said. "We currently expect the second half of fiscal 1992 to be much stronger than the first half of the year." Syntex corporate sales increased 12% for the quarter, to $ 508 mil. Net income increased 6% to $ 132.3 mil. Freiman forecast double-digit earnings growth for the full year. Chart omitted.

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