Indivior PLC (LON:INDV) has warned that the hit to full-year net revenues from the launch of a generic competitor to its blockbuster opioid addiction treatment could be “materially higher” than the US$25mln it had previously forecast.
Shares dived 21% to 262.9p in early deals on Wednesday, meaning they have now lost a third of their value since the beginning of June.
READ: Indivior wins preliminary injunction
The FTSE 250 drugmaker, which also reported a second straight drop in quarterly profit, is embroiled in a legal battle with Indian giant Dr Reddy’s, which recently launched a cut-price version of Suboxone – Indivior’s star asset which accounts for 80% of its annual sales.
Indivior is adamant that the generic infringes one of its patents and is in the process of going through the courts to get legal confirmation that Dr Reddy’s will have to wait until 2022 to bring its drug to market, which is when Suboxone’s patent expires.
Dr Reddy’s, unsurprisingly, believes its formulation, which has been approved by the US Food and Drug Administration, doesn’t break any laws.
Because of that, it went ahead and started to sell its copycat drug last month, although it was only able to do so for a matter of hours as Indivior’s lawyers won a court order blocking it from making further sales until an outcome in the patent case is reached.
That case could reach the courts as early as the end of this year should US judges decide to expedite the hearing. If the fast-track process isn’t granted, it could take more than a year for a decision to be made.
Guidance still withdrawn
Although Dr Reddy’s was only able to sell its version of Suboxone for a short amount of time, being a generic drugmaker it is well-versed in getting its products into the market quickly, and Indivior isn’t sure exactly how much it was able to ship out.
It had previously warned that net revenues would likely take a hit of at least US$25mln this year, but having seen its market share fall rapidly to below 50% (this time last year it was almost at 60%), Indivior said today that figure could be “materially higher”.
Until it becomes clear just how much of its drug Dr Reddy’s was able to sell, Indivior has withdrawn its full-year guidance, although it hopes to have a better idea by the start of November when it will post a third-quarter update.
Adjusted net income fell 21.3% to US$70mln in the three months ended June 30 from a year earlier, while revenue fell 6.9% to US$268mln in the quarter.
--Updates for quarterly results and share price--