Indivior unable to provide guidance amid Suboxone uncertainty

Indivior said it was unable to give investors an indication of revenue and profit for the current year due to uncertainty about how its star drug will affect by copycat versions.

After US courts earlier this week opened the door for rival drug manufacturers to sell their generic versions of the market leading Suboxone Film, management said they were unable to provide group-wide guidance at this time.

Launches by India's Dr Reddy's Laboratories and Alvogen Pine Brook are expected imminently, but "at risk" as Indivior's patent claims are still pending other court rulings. Indivior is also throwing its hat in the ring and is preparing the launch of its own generic of buprenorphine/naloxone sublingual film to participate in the generic market.

However, for Sublocade, a 'depot' injection of buprenorphine that provides a monthly treatment for opioid addiction, which was launched last year, the company guided to net revenue of $50-70m and said combined expenses on selling, general and administrative plus research and development were expected to be roughly $440-460m, excluding exceptional items.

Perseris, a new, long-acting injectable treatment for schizophrenia, was made available in the US in late November and will be commercially launched next week, with a field force of 50 salespeople.

Results for calendar 2018 had been largely flagged in December, with sales down 9% to $1.01bn aided by a $12m contribution from Sublocade.

Adjusted operating profits fell 19% to $332m but were slightly better than some analysts expected, while earnings per share remained flat at 37 cents after lower finance costs.

The year ended with a balance of $924m cash, with net cash up $305m to $681m. Repayments of $235m were made against a term loan, with $243m remains outstanding.

Indivior is holding onto cash and is carrying a $438m provision for investigative and antitrust litigation matters as it continues in "advanced discussions" with the US Department of Justice about a possible resolution to its investigations, although it is not possible to predict with any certainty the timing or cost of any resolution. There are also civil investigations from a number of states and a US Federal Trade Commission investigation is also pending.

Chief executive Shaun Thaxter said: "As we enter FY 2019, we assume we face the imminent 'at-risk' launch of generic rivals to Suboxone Film in the US. We have prudently prepared for this event, planning and taking the required actions to help ensure we can deliver on our strategic priorities despite the near-term top-line pressures that generic competition to Suboxone Film will bring."

Shares in the company rose 5% to 113.73p on Thursday morning, but are still down almost 80% from their all-time high above 500p last June.