viewMylan Inc.

Mylan pushes back all 2017 US drugs launches to next year

The company lowered guidance as a result of the decision, which was made against a backdrop of an "uncertain US regulatory environment"

Drugs developer
"We have elected to defer all major US launches from our full year 2017 financial guidance to 2018"

Shares in UK-based drugs developer Mylan NV (NASDAQ:MYL) slid in early deals as it said it would defer this year’s major US launches until 2018.

The Hertfordshire-based company said the decision had been taken in view of the uncertain US regulatory environment.

The decision will affect the launch of generic versions of the Advair and Copaxone drugs.

As a result, the company said it now expected full-year revenues would fall somewhere in the range of US$11.5bn and US$12.5bn, while adjusted earnings per share (EPS) were seen clocking in at between US$4.30 and US$4.70.

Shares in Mylan were off 5% at US$30.18 in early deals, while Teva, which features multiple sclerosis drug Copaxone as a major part of its portfolio, edged up 0.5% in a falling market.

In the second quarter Mylan posted adjusted EPS of US$1.10, down 5% year-on-year, on revenues that were up 16% on a year earlier to US$2.96bn.

Revenues in North America fell 9%, but the fall was more than offset by a 59% increase in revenues in Europe to US$954.3mln and a 29% increase to US$692.6mln in the rest of the world.

“As we look to 2018, we are moving our target of $6.00 in adjusted EPS to at least $5.40. This new target represents 20% growth from 2017 based on the midpoint of our revised adjusted EPS guidance range. Looking ahead, we continue to have great confidence in our underlying business in every region and the opportunities we have for long-term growth," said Heather Bresch, the chief executive officer of Mylan.

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