* Novo chairman says U.S. approval of Tresiba a top priority
* Says stock split not currently on the agenda
* Says company exploring an increase in dividend
By Shida Chayesteh
COPENHAGEN, March 8 Denmark's Novo Nordisk
, the world's biggest insulin producer, is confident
U.S. authorities will approve its new long-acting product
Tresiba, its incoming chairman said on Friday.
U.S. regulators last month unexpectedly refused to approve
Tresiba until the group conducts extra tests for potential heart
risks, dealing a blow to one of its key products as well as to
its share price.
The drugmaker shed about $14 billion in market value on Feb.
11 after the decision by the U.S. Food and Drug Administration
(FDA) was published, although the shares have since recovered
much of the fall.
Goran Ando, who will take over as chairman of the board at
Novo Nordisk after the annual general meeting on March 20, told
Reuters that getting Tresiba approved by the FDA is one the most
important short term goals for the group.
"I have all the confidence in the world that we will do
that," Ando said in an interview, without going into further
"It will take more time than we thought but we will get
there," he told Reuters, adding the board was surprised by the
FDA's decision last month.
Most investors had expected a green light from the U.S.
watchdog, following a positive recommendation from an advisory
panel to the FDA last November, despite earlier signals that
there might be heart issues with the medicine.
There has been speculation about a potential stock split as
Novo's share price has exceeded 1,000 Danish crowns and the
outgoing chairman said in January that approval of Tresiba in
the Unites States was a condition for a decision to proceed.
Asked about prospects for a stock split, Ando said: "It is
nothing that is currently on the agenda."
He added the board would look into increasing dividends.
"I don't think you will see very dramatic changes. But we
will look at this," Ando said.
In January, Novo had raised its sales and profit forecasts
for 2013 on hopes that Tresiba, also known as degludec, would
soon win approval in the United States and add momentum to
But following the FDA decision the drugmaker, which is
banking on Tresiba to keep it in the lead in diabetes care, has
said the earliest it could provide the data requested by the
U.S. authorities is in 2015.
As the world suffers from an epidemic of type 2 diabetes
tied to over-eating and lack of exercise, demand for treatments
has snowballed. Novo has benefited more than any other company
because it is so focused on diabetes, lifting its shares to a
lofty premium over other European drugmakers.
COMFORTABLE WITH DIABETES FOCUS
That strategy was not set for any major change under the
"Is there a reason to change the fundamental things, I don't
think so," Ando said.
"I am very comfortable with our focus on diabetes," he said.
The global diabetes market should grow 10 percent annually
through 2020, Citigroup estimates, as Western lifestyles are
adopted in emerging markets and obesity affects U.S. citizens at
Ando said rising competition would present challenges.
"It is a challenge to continue to grow as fast as we have
done," he said.
"In the overall diabetes arena, I think it is fair to say
that competition is increasing."
Novo Nordisk has overtaken Norway's Statoil as the
Nordic region's biggest company by market capitalisation,
dominating its home stock market which last month changed the
benchmark, from next week, to a new index that caps Novo's
weighting at 20 percent.
Shares in Novo Nordisk traded flat at 1,003.00 crowns per
share at 1345 GMT, against a 0.5 percent rise in the Copenhagen
stock exchange's benchmark index.