Mylan piles generic Copaxone pain on Teva as partner Synthon nabs EU green light

Bernstein's Ronny Gal predicted this week that U.S. Copaxone generics could spur a 29-cent EPS decline.

Just two days after Teva learned Mylan had won an FDA approval for its long-acting Copaxone generic, Mylan’s European partner announced it’d be giving Teva trouble across the pond, too.

Thursday, Synthon said it had netted regulatory clearance for the version it shares with Alvogen of the 40 mg multiple sclerosis blockbuster. The pair already market a copy of Teva’s 20 mg original formulation, but the longer-acting drug makes up more than 75% of European prescriptions, Reuters notes.

RELATED: Mylan surprises analysts, Teva with long-delayed Copaxone approvals

The European competition piles on more pain in what’s already been a tough stretch for Teva. The company started the year by walking back its 2017 sales predictions by more than $1 billion—an exercise it would repeat just seven months later. Exits for its CEO and CFO followed the first forecast edit, and in August, it announced it would lay off 7,000 workers and slash its dividend by 75%.

That’s not to say there haven’t been some recent bright spots. Last month, the generics giant named Novo Nordisk vet Kåre Schultz to its CEO post, a move that cheered investors. And later that day, the debt-laden company made good on some asset-sale promises, unloading its Paragard intrauterine copper contraceptive for $1.1 billion in cash.

Mylan’s U.S. Copaxone 40 mg approval, though, crushed momentum; many analysts had written off a green light for the candidate until next year after Mylan in June said it had received an “information request” from regulators.

“Big win for them,” Evercore ISI analyst Umer Raffat wrote of Mylan, with Bernstein’s Ronny Gal predicting a 29-cent earnings per share decline for Teva.