Teva details expected sales, profit hit from US generic Copaxone launch in 2014

Teva said Tuesday that it expects overall sales in 2014 to be between $19.3 billion and $20.3 billion if generic versions of Copaxone (glatiramer acetate) reach the market in the US on June 1 next year. The company added that if the FDA approves generic versions of the multiple sclerosis drug from companies including Novartis' Sandoz unit, Momenta Pharmaceuticals, Mylan and Natco Pharma, earnings will be in the range of $4.20 per share to $4.50 per share.

Acting CEO Eyal Desheh remarked "2014 will be a pivotal year for Teva and a year of major transitions across the company." Last month, a US Supreme Court justice declined a request from the company for a stay of an appeals court ruling made earlier this year that shortened patent protection on Copaxone from September 2015 to May 2014. The drugmaker indicated Tuesday that its forecast, which compares to analyst expectations of sales at around $19.9 billion and earnings of $4.92 per share, assumes the launch of "at least two AP-rated generic competitors to Copaxone."

Teva said that each month of a delay in the launch of generic versions of Copaxone in the US will contribute approximately $78 million to net revenues and $0.08 to earnings per share. The company indicated that if no generic versions reach the market next year, overall sales will be between $19.8 billion and $20.8 billion, with earnings of $4.80 per share to $5.10 per share. According to the drugmaker, under the two scenarios, annual sales of Copaxone will be in the ranges of $3.1 billion to $3.2 billion and $3.6 billion to $3.7 billion, respectively.

The company added that both forecasts assume the launch of a three-times-a-week version of Copaxone early next year and exclusive sales for a generic version of AstraZeneca's Pulmicort (budesonide) in the US throughout 2014.

Commenting on the forecasts, Excellence Nessuah Investment House analyst Gilad Alper said "we have to sit and wait and see if we have generic Copaxone and how many companies launch. It makes a big difference if there’s one or two or three." Alper added that the company is "making a lot of very optimistic assumptions regarding the non-Copaxone business." Teva recently said that it expects to generate sales of $3 billion by 2020 from its new therapeutic entities programme, which was started last year.

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