Momenta receives approval for 40mg generic Copaxone


IBI Investment: The new competition will cost Teva $0.15 per share in profit in 2018.

Momenta Pharmaceuticals today announced that it had obtained approval to market a generic version of 40-milligram Copaxone, Teva Pharmaceutical Industries Ltd.'s (NYSE: TEVA; TASE: TEVA) flagship drug, in the US. While this approval was expected, Teva's guidance for 2018, which was in any case lower than the analysts' forecasts, said that it believed that Momenta would not launch its generic product before April.

Teva's guidance for 2018 assumes that sales of Copaxone will total $1.8 billion. The downside is probably already taken into account in company's guidance. Teva predicted that its revenue would total $18.3-18.8 billion, with a non-GAAP net profit of $2.25-2.50 per share.

Momenta, which is already marketing a generic version of 20-milligram Copaxone, will become Teva's second competitor in the generics market after Mylan N.V. (Nasdaq: MYL), which began marketing its generic version of the drug last October. Most patients taking Copaxone use the 40-milligram version. Teva's revenue from Copaxone sales in the US were down 20% to $622 million in the fourth quarter as a result of competition from Mylan, which introduced price competition.

Momenta's FDA authorization was delayed by an FDA warning about a Pfizer plant that is part of Momenta's generic production chain. Momenta recently announced that the FDA had completed its examination, and predicted that it would soon be granted authorization, which has now happened.

Teva yesterday published its expanded report for 2017 showing that CEO Kare Schultz received $17 million in remuneration, mostly in the form of shares. Troubles previously reported by the company included its relatively low guidance, an enormous write-down of goodwill in 2017 for the company's generics business in the US, and a possible delay in the launching its original drug for treatment of migraine headaches, the company's purported growth engine in the coming years.

Poalim IBI Underwriting and Investments Ltd. (TASE:PIU) pharma and medical analyst Steven Tepper believes that the immediate launch of Momenta's generic drug will reduce Teva's 2018 profit by $0.15 per share, which is within the company's guidance of $2.25-2.50 per share. "Schultz has already substantially lowered expectations for 2018, mostly as a result of the ongoing price erosion in the US generics market and the expectation of more competition for Copaxone. We believe that there is a good chance that under its new CEO, Teva will achieve the upper part of the conservative guidance it provided," he wrote.

Published by Globes [online], Israel Business News - - on February 13, 2018

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