Indivior PLC’s (LON:INDV) profits have fallen by a quarter so far this year after the launch of a generic competitor cut the market share of its blockbuster opioid addiction treatment.
For the nine months ended September 30, Indivior’s net revenue fell 8% to US$768mln (Sep 17: US$828mln), while adjusted operating profit dived 25% to US$254mln (Sep 17: US$333mln).
READ: Indivior warns of further impact from Suboxone copycat
Indian drugs giant Dr Reddy’s briefly launched its copycat version of Suboxone ‘at risk’ – meaning it did so while litigation was still ongoing.
Indivior insists that Dr Reddy’s drug breaches one of its patents, but a US patent court found against it last summer, a ruling which it has subsequently challenged.
Encouraged by the verdict, Dr Reddy’s sought FDA approval for its cut-price version which it was granted earlier this year.
The drug went on sale but only for a matter of hours back in June before Indivior’s lawyers won a court order blocking it from making any further sales while it disputed the court’s earlier finding.
Fina hearing possibly later this year
That injunction is still in place pending a final hearing, which is due to take place towards the end of this year or early 2019.
Despite only having a small window in which it could sell its treatment, Dr Reddy’s, being a generic drugmaker, is well-versed in getting its products to market extremely quickly.
Indivior still isn’t entirely sure how much its competitor managed to ship, but it was enough for Suboxone’s market share to rapidly fall below 50%, although it since settled just above that.
Making things worse is that Suboxone’s successor, a once-monthly injection called Sublocade, hasn’t exactly hit the ground running.
Doctors have been reluctant to prescribe it due to what Indivior has called “friction in the new distribution and reimbursement model”, although it is still confident the treatment will be a future blockbuster once the early issues are ironed out.
Guidance reinstated
With all of this going on, Indivior withdrew its guidance earlier on in the year, saying that there was too much uncertainty for it to give forecasts with any degree of confidence.
But it reinstated them today and now expects net revenue of between US$0.99-1.02bn and net income in the range of US$230-255mln.
In its first-quarter update, Indivior was forecasting net revenue in the range of US$1.13-1.17bn and net income of between US$290-320mln.
Part of that is to do with the poor performance of Sublocade, which the firm had initially thought would generate sales of up to US$100mln but now reckons will only contribute US$10mln at best.
Indivior shares were down 4.4% to 181p in late-afternoon trading on Thursday.