* Q2 net profit up 4 percent at 7 billion DKK
* Q2 operating profit up 2 pct at 8.7 bln DKK
* Shares up 1.5 pct
(Adds comments from CEO, analysts, share price)
By Stine Jacobsen and Ole Mikkelsen
COPENHAGEN, Aug 7 Novo Nordisk <NOVOb.CO said on
Thursday it could launch its new long-acting insulin Tresiba, a
crucial future growth driver for the Danish company, at the
start of 2016 in the United States.
The world's top insulin maker is battling to maintain strong
profit growth after the U.S. Food and Drug Administration
refused to approve Tresiba due to heart-risk concerns and the
company lost contracts to supply a U.S. pharmacy chain.
Investors were likely to welcome the more detailed timetable
for Tresiba in the United States. Novo Nordisk had previously
said it would have additional data ready by mid-2015, without
outlining further steps.
"They have moved the (Tresiba) data six months forward,
which is certainly not unimportant for Novo. It looks like there
are no problems with the study, so it is a very positive
signal," said analyst Michael Friis Jorgensen of Alm Brand,
which has a "buy" rating on Novo Nordisk shares.
The FDA told Novo Nordisk to conduct extra tests and the
company now says the data should be complete by the end of the
year or the start of 2015, allowing it to submit an analysis in
the first half of 2015.
"If we calculate the best possible scenario then we could
see an approval by the end of the year, meaning a launch into
the beginning of 2016," Novo Nordisk Chief Executive Lars Rebien
Sorensen told journalists on a call.
He was speaking after the company reported second-quarter
results that were more or less in line with analyst expectations
and maintained a 2014 forecast for a 7-10 percent rise in sales
and around 10 percent growth in operating profit.
It said operating profit reached 8.73 billion Danish
crowns($1.57 billion) in the second quarter compared to
expectations of 8.56 billion crowns, on revenues of 21.63
billion crowns against a consensus forecast of 21.7 billion
Shares in Novo Nordisk rose as much as 1.5 percent before
retreating to stand 0.75 percent higher at 254.70 crowns each.
The main Copenhagen stock exchange index was down a touch
U.S. PRICING PRESSURE
Novo Nordisk has been under pressure in the United States,
its largest market, due to competition from generic drugs and
broader pricing pressure. Last year it lost two contracts to
supply Express Scripts Holding Co. representing some
40-45 million U.S. customers.
Sales of Victoza, used for patients with type 2 diabetes who
can still generate some insulin themselves, rose 15 percent in
North America and Novo increased its market share in the GLP-1
sector to 69 percent from 65 percent.
But Victoza was one of the products hurt by the loss of
Express Script contracts and its sales growth did not satisfy
all analysts, including those from Nordea and Berenberg.
"Victoza sales ... were 3 percent below consensus and the
GLP-1 market growth rate continues to struggle. The category is
now seeing tougher competition from oral drugs such as the
DPP-IVs and SGLT-2 inhibitors," Berenberg analyst Alistair
Campbell said in a note.
Sorensen conceded that the U.S. market was a challenge for
Novo Nordisk after rivals Sanofi and Eli Lilly
both reported growth in their diabetes segments.
"It is clear that the situation which occurred towards the
end of 2013 is persisting into 2014, with increasing pricing
pressure in almost all segments," Sorensen said.
In the year to date, Novo Nordisk shares are up over 28
percent, outperforming Sanofi's 3 percent and Eli Lilly's 20
(1 US dollar = 5.5691 Danish crowns)
(Additional reporting by Teis Jensen; writing by Sabina
Zawadzki; editing by Tom Pfeiffer)