Mylan Defers Product Launches -- Update

By Imani Moise 

Mylan NV said it wouldn't launch any major new drugs in the U.S. market this year, deferring the introduction of two highly anticipated generic drugs amid regulatory uncertainty.

The delay cut the drug maker's earnings outlook for this year. Its shares were down 4.5% at $30.36 in early trading.

Mylan now expects revenue this year to come in between $11.5 billion and $12.5 billion, compared with prior guidance of $12.25 billion to $13.75 billion. The company also cut its forecast for adjusted earnings per share to a range of $4.30 to $4.70, from $5.15 to $5.55 previously.

The company has been developing generic versions of Teva Pharmaceutical Industries Ltd.'s Copaxone and GlaxoSmithKline PLC's Advair, but has raised concerns over its ability to quickly win regulatory approval after executives said earlier this year that the Federal Drug Administration had asked for more information.

"While we may experience delays, mostly in the U.S., in realizing some of these opportunities, our confidence in our ability to bring these important products to market and maximize their potential has not changed," said President Rajiv Malik.

Mylan, like many drug companies, has been coping with increased competition from cheaper, generic versions of its signature drugs as patents expire. Its sales in the U.S. slid 9% during the quarter as generic versions of Mylan's EpiPen Auto-Injector launched. Excluding the dip in EpiPen sales, the segment saw a 4% increase in sales.

Mylan said it expects generic price erosion to continue this year, at a rate in the mid-single digits globally and high-single digits in North America.

In all for the second quarter, Mylan missed views, reporting earnings of $297 million, or 55 cents per share, up from $168.4 million or 33 cents per share a year earlier. On an adjusted basis, earnings fell to $1.10 per share from $1.16 per share. Revenue jumped 16% to $2.96 billion.

Analysts polled by Thomson Reuters had forecast earnings of $1.16 per share on $3.04 billion in sales.

Before premarket trading, the stock had fallen 17% so far this year.

Write to Imani Moise at [e-mail]

(END) Dow Jones Newswires

August 09, 2017 09:57 ET (13:57 GMT)

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