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 The company said it had increased provisions for investigative and
antitrust litigation matters by $185 million to $438 million,
sending the shares 9 percent lower by 1045 GMT.
The U.S. Department of Justice is probing Indivior's marketing
practices and the company also faces claims it tried to delay entry
of generic versions of some of its products.
Chief Executive Shaun Thaxter declined to say whether the increased
provision signaled any settlement was near. However, he said he was
"very, very confident" about the future.
Indivior believes its long-lasting Sublocade injection, which is
being launched in the United States in the week of Feb. 26, will
become a blockbuster medicine, despite the fact initial sales are
likely to be slow.
"The net revenue potential of this product is well above $1 billion
but we don't want people to be unrealistic about what we will
achieve in the first year," Thaxter said in an interview.
Sublocade represents a new approach to treating addiction. Instead
of going to the pharmacy to pick up tablets or Indivior's existing
under-the-tongue film, the new injections will be delivered direct
to doctors' offices for administration.
Thaxter said it would take time for the new distribution model to
bed down, adding: "We would expect to see some very noticeable sales
growth by the last quarter (of 2018)."
Overall, the company expects group sales of between $1.13 billion
and $1.17 billion in 2018, up from $1.09 billion last year, helped
also by the expected launch of a long-acting injection for
schizophrenia towards the end of the year.
ADDICTION EPIDEMIC
The rise of opioid addiction to epidemic proportions in the United
States has spurred demand for Indivior's products, and the market
for treatments to suppress cravings has grown by 10 percent annually
over the last five years.
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U.S. deaths from overdoses jumped 21 percent to 63,000 in 2016 and
the opioid crisis is now reducing overall life expectancy among
Americans, according to official figures.
Indivior, which was spun off from Reckitt Benckiser in 2014, has
been treating addiction for more than two decades, initially selling
tablets to help wean addicts off opioids including heroin and
prescription painkillers. Now its big seller is Suboxone Film, which
patients place under their tongue or inside their cheek once a day
to suppress cravings.
Sublocade, which could be launched in Canada, Australia and Europe
from late 2019, is the latest iteration and is designed to eliminate
any risk that treatment could be diverted and misused by putting the
product exclusively in the doctor's office.
Competition is growing but Indivior has had some lucky breaks
against rivals in recent months, with regulatory delays to both a
rival long-lasting injection from Camurus and a generic version of
its film from Dr. Reddy .
Ultimately, Indivior's opioid addiction business could be in
jeopardy if the epidemic of drug misuse is brought under control,
but Thaxter said his researchers were widening their focus to other
addictions, such as cocaine and alcohol.
"As we continue to expand the scope of our business beyond the
opioid crisis to other addictions, there will continue to be
sustainable business growth for shareholders as well," he said.
(Reporting by Ben Hirschler; Editing by David Holmes)
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