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Executive Summary

Robins' pro-motility agent Reglan (metoclopramide) sales grew by approximately 50% for the second year in a row in 1984 to approach $60 mil., the company indicated in its recently released annual report for 1984. "Sales of Reglan, the leading product family among the company's ethicals, rose 49%" in 1984 on top of the drug's 53% sales increase in 1983 to approximately $40 mil., the annual report notes. With the passage of the patent/ANDA bill into law, and its patent protection expired, metoclopramide is now ANDA-able. As a result, Reglan will soon be vulnerable to generic competition. Robins continues to pursue expanded labeling for Reglan. Last fall, Robins received FDA approval for use in gastroesophageal reflux disease and for healing of esophageal ulcers. The company noted that "full scale marketing efforts emphasizing the new labeling were initiated in October." In addition, "a supplemental NDA was submitted to FDA to expand the use of Reglan injectable for post-operative prevention of nausea and vomiting," Robins reported. Another supplemental NDA has been submitted to the agency for the prevention of perioperative aspiration pneumonia, the company said. Although mired in the Dalkon Shield litigation, Robins continued to show good operating growth in 1984, with operating earnings up 21.2% to $128.1 mil. on a sales increase of 12.1% to $631.9 mil. However, a write off of $489.1 mil. during the fourth quarter to cover its Dalkon Shield reserve and a $60 mil. increase in litigation expenses and settlements to $78 mil. contributed to Robins $461.6 mil. loss in 1984. Overall, Robins' ethical pharmaceutical sales increased 6.3% to $361.9 mil. in 1984 and generated a 15.8% jump in operating earnings to $100.3 mil. With a 63% sales gain in 1984, Micro-K sales have increased "more than six-fold over the past two years," Robins said. Micro-K currently holds the number two market share position in the U.S. potassium chloride supplement solid dose market, the firm added. The performance of Robins' generic drug subsidiary Elkins-Sinn in 1984 was hampered by the discontinuation of a line of vaccines at the end of 1983, the annual report indicates. The annual report says only that Elkins-Sinn "made further progress in 1984," which included a 12% sales gain after adjustments for the discontinued biologicals business. A recent SRI report on the generic industry estimated Elkins-Sinn's 1984 sales to be in the $90 mil. range. Robins' 1983 annual report showed that its generic drug subsidiary's sales for that year approached $80 mil. "Especially noteworthy," Robins said, "was the strengthening of Elkins-Sinn's number two position in the U.S. heparin market." Robins also high-lighted the introduction last year of Elkins-Sinn's Duramorph -- a 24-hour preservative-free injectable formulation of morphine. In the OTC area, Robins reported that in 1984 Robitussin "advanced its leading share of the U.S. market in combined food and drug outlets to nearly 27.5%." However, while Robitussin Night Relief "showed good sales growth in 1984," Robins said that first full-year sales of its 12-hour controlled release cough suppressant, Extend 12 Liquid, were "dissappointing." The report adds: "Recognizing that consumers have yet to fully accept this product's unique delivery system, the consumer products div. is stepping up its Extend 12 promotional efforts and is expanding them to include health care professionals." Extend 12 is a sustained release dextromethorphan product licensed from Pennwalt that makes use of that firm's Pennkinetic technology. Robins Has Paid For Removal Of 4,437 Dalkon Shields And 777 Exams Through End Of March Combined ethical and OTC sales of Robins' cough/cold product line worldwide were generally flat in 1984, contributing approximately $140 mil. in sales based on a percentage share of overall corporate sales, the annual report shows. Robins' Chap Stick continued to hold its market leading position in 1984 with a U.S. market share "in excess of 56%," the annual report states. Robins added that Sunblock 15 had a "good" sales increase in 1984, while Lip Soother "fell short of expected sales during its first full year on the market." On the Dalkon Shield, Robins said it believes the $489.1 mil. reserve fund (after tax) "represents a reasonable estimate of minimum costs for compensatory damages and legal expenses arising from pending and future claims." The company added that the reserve "may not necessarily" equal the amount of Robins' final loss from the litigation. Robins said "it is not likely that the ultimate loss will be less than the amount reserved." Robins noted that its Dalkon Shield removal program, initiated last October, looks to be achieving its goal. "More than 18,250 inquiries have been received on our toll-free telephone lines and, as of March 29, 1985, the company has paid for 777 examinations and 4,437 removals," the company reported. "Interestingly, the number of removals seems to confirm our view that far fewer Dalkon Shields have remained in use than certain critics of the product have suggested," the annual report adds.

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