Mylan Defers Product Launches -- Update
August 09 2017 - 9:12AM
Dow Jones News
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 imani.moise@wsj.com
(END) Dow Jones Newswires
August 09, 2017 09:57 ET (13:57 GMT)
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