2nd May 2019 13:07
LONDON (Alliance News) - Embattled drug maker Indivior PLC on Thursday said underlying market growth and strong initial sales of its own generic meant revenue actually rose in the US despite a significant loss of market share for Suboxone Film.
Shares in Indivior were up 8.6% at 41.98 pence on Thursday afternoon.
In the US, net revenue was up 1.5% to USD200 million for the three months to March 31 versus USD197 million the year before after Indivior launched a generic version of its own Suboxone Film opioid replacement drug.
This was despite a significant loss of market share for Suboxone Film itself, which exited the quarter with a 40% market share and a 48% average for the period. In the same quarter of 2018, Suboxone Film's average and exit market share was 53%.
Indivior has been battling to prevent the launch of a generic US competitor to Suboxone Film but lost its fight in February when the US Supreme Court denied an injunction. Since then, the sale of generic versions of Suboxone Film has been legal.
Group revenue fell 6.7% to USD238 million from USD255 million, however, brought down by a one-time net revenue gain in Canada in the same quarter last year which did not repeat.
Profit shrank in the first quarter of 2019 after the company incurred high exceptional costs, having posted a one-time revenue gain in 2018.
The drug maker posted a USD77 million pretax profit for the three months to march 31, down 31% from USD111 million the year before as the company incurred USD27 million of exceptional costs, reversing its USD17 million exceptional gain for the same quarter of 2018.
Indivior also elaborated on its recent indictment on 28 counts by a US grand jury, which charged the company with false claims made about the safety of Suboxone Film and the misuse of a telephone programme connecting addicted patients to doctors.
The US Department of Justice "is seeking the forfeiture of all assets derived from the commission of the alleged offences, including but not limited to USD3 billion", Indivior said.
"The group's external counsel has advised it has strong defences to the government's charges with which the group will vigorously defend itself. However, an adverse outcome at trial could also result in the group's exclusion from participating in US federal health care programs," Indivior added.
Indivior maintains a USD438 million provision relating to the Department of Justice action, which its advisors have said will be "materially in excess " of the fines, forfeiture, and restitution that could be incurred if Indivior loses its case.
Indivior issued guidance for 2019, which focuses on its re-release injectable opioid replacement, Sublocade, which recorded revenue of USD11 million in the quarter. This is on track for Sublocade guidance of net revenue between USD50 million and USD70 million.
"We continue to believe Sublocade to be a transformational treatment for opioid dependence and we will not be distracted in our efforts to bring this important new option to patients in the US,2 said Indivior.
Indivior has been encouraged by early market reception to its schizophrenia drug, Perseris, which was launched at the end of the first quarter of 2019. The drug is not yet expected to contribute to annual guidance.
Indivior Chief Executive Shaun Thaxter said: "Our first-quarter performance only strengthens our confidence that we are putting the building blocks in place for a return to sustained growth, led by Sublocade and Perseris, and I look forward to reporting our progress throughout the year."
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