* Eyes early 2014 approval
* Q1 adjusted EPS $1.12 vs $1.10 forecast
* Q1 revenue $4.9 bln vs $4.85 bln forecast
* Reaffirms 2013 outlook for revenue, profit
By Tova Cohen
TEL AVIV, May 2 Teva Pharmaceutical Industries
is banking on approval in early 2014 for a new
thrice-weekly version of its multiple sclerosis treatment
Copaxone to bolster sales ahead of a likely onslaught from
copies of its best-selling drug.
Teva, itself the world's biggest maker of generic medicines,
posted lower first-quarter profit as revenue in the United
States was hurt by a drop in sales of a key branded product due
to generic competition.
The company is five months into a sweeping reorganisation it
promised would bring extra rewards for shareholders.
The Israeli company has grown rapidly in recent years
through a series of multibillion-dollar acquisitions but its
shares have badly underperformed its rivals in the past two
Among key challenges is the looming 2015 patent expiry of
Copaxone, the world's top treatment for multiple sclerosis which
accounts for about 20 percent of Teva's sales and 50 percent of
Chief Executive Jeremy Levin said Teva in late March filed
for U.S. Food and Drug Administration approval for its
three-times-a-week injectable dose of Copaxone, which currently
is administered daily.
"We anticipate FDA action in the first quarter next year,"
Levin told a conference call of analysts on Thursday.
Copaxone posted a 17 percent rise in global sales in the
first quarter to $1.1 billion. The drug faces competition from
oral treatments that are already available or expected to hit
the market in coming years.
"Global Copaxone sales were 10 percent above our estimate,
driven by higher-than expected U.S. sales," Morgan Stanley
analyst David Risinger said.
The upside on Copaxone helped partly offset
lower-than-expected global generic sales of $2.3 billion, he
U.S. generic sales fell 27 percent as a few products faced
increased competition. European generic sales rose 9 percent as
Teva increased its penetration in France and Italy.
Teva earned $1.12 per diluted share excluding one-time items
in the quarter, down from $1.47 a year earlier as revenue fell
to $4.9 billion from $5.1 billion. It was forecast to earn $1.10
a share excluding items on revenue of $4.85 billion, according
to Thomson Reuters I/B/E/S.
Teva's U.S. sales, which comprise 50 percent of group
totals, fell 11 percent in the first quarter to $2.4 billion as
sales of sleep disorder drug Provigil declined substantially due
to generic competition that began in the second quarter of 2012.
Teva plans to focus on new therapeutic entities (NTEs),
which could be new uses, formulations, delivery methods or
combinations of existing products. So far 13 have been approved
for development this year and Teva expects some of these to be
launched in the next few years.
Teva reaffirmed its full year 2013 outlook for revenue of
$19.5 billion to $20.5 billion and adjusted EPS of $4.85-$5.15.
Teva declared a quarterly dividend of 1.15 shekels (32
cents) a share, unchanged from the fourth quarter when it raised
its payout by 15 percent.