3rd May 2016 13:03
LONDON (Alliance News) - Shares in Indivior PLC were lingering at the bottom of the FTSE 250 Tuesday despite the company reiterating its guidance for the full year, as it reported a fall in pretax profit for the first quarter of 2016.
The FTSE 250-listed company, which focuses on its suboxone film medication for opioid dependence, said its pretax profit for the quarter to the end of March was USD86.0 million, down from USD102.0 million a year earlier. This was predominantly as a result of higher selling distribution and administrative expenses, as well as a step up in research and development costs.
Net income for the quarter was USD50.0 million, down from USD77.0 million, in part due to an exceptional tax payment made in the quarter.
Indivior, spun out from blue-chip consumer health and hygiene products giant Reckitt Benckiser Group PLC in late 2014, said net revenue grew 3.0% year-on-year in the quarter to USD258.0 million from USD251.0 million, helped by an increase in the price of suboxone film.
This was the first increase since 2012 but was offset by tactical rebates in connection to formulary access, the company said, and by annualisation of prior year rebates.
Whilst revenue grew in the US, it fell 8% in the Rest of the World, hit by the strong US dollar, as well as continuing price constraints from government austerity measures and a forced switch to generic alternatives in Europe.
The company's suboxone film market share in the US was 60%, slightly better than the 59% market share it held for 2016, with the total volume sold in the US ahead of the previous year.
Indivior's suboxone film has been facing generic competition in the US, and Indivior said there had been some "additional discounting" from branded competitors in the quarter, however, this has had very limited impact, though Indivior continued to offer some tactical rebates in connection to the product.
Indivior said its new product pipeline has continued to progress, with phase three trials of its Buprenorphine Monthly Depot treatment on track and the results of an efficacy trial due in the third quarter of this year.
The group confirmed its guidance for 2016 of net revenue to be USD945.0 million to USD975.0 million, with net income to be between USD155.0 million and USD180.0 million, excluding exceptional items and at constant exchange rates.
However, the company also reiterated a cautious tone, saying the guidance assumes no "material change" to current market conditions in the US, no disruption to US generic pricing, no generic film entry and a limited hit from branded competition.
It also includes Indivior's "strategic decision" to reinvest at least an additional USD35 million in research and development and activity ahead of the expected launch of its buprenorphine monthly depot for the treatment opioid use disorder. This treatment is on track with phase III trials due to read out late in the third quarter.
Last Thursday the company said that a phase I study of its treatment for opioid dependence RBP-6300 did not achieve the anticipated pharmacokinetic profile in humans to justify proceeding further with it, and the approval of schizophrenia treatment RBP-7000 is likely to be delayed.
There was a manufacturing issued identified with one out of the six stability batches of RBP-7000 that are required for a new drug application submission. Indivior believes this issue is now rectified, and it will manufacture additional batches to provide the required data.
Whilst the delay is "not a fundamental problem", Chief Executive Shaun Thaxter said in a statement Tuesday, it will result in a change in the company's original development timeline. It now expects approval for this product to be delayed until mid-2018.
"We had a good start to the year with first quarter numbers exceeding our plan which anticipated no material deterioration in the trading environment," said Thaxter in a statement.
Indivior shares were down 12% to 141.00 pence on Tuesday, the worst performer in the FTSE 250.
By Sam Unsted; [email protected]; @SamUAtAlliance and Hana Stewart-Smith; [email protected]; @HanaSSAllNews
Copyright 2016 Alliance News Limited. All Rights Reserved.
Related Shares:
Indivior