5th May 2015 11:51
LONDON (Alliance News) - Indivior PLC on Tuesday said its pretax profit in the first quarter fell on the back of weaker revenue and higher operating costs, but the company said its RBP-7000 product has met the primary and secondary endpoints in its phase 3 trial for the treatment of schizophrenia, which sent its shares pushing higher on Tuesday afternoon.
Shares in Indivior were up 5.4% to 214.10 pence early afternoon on Tuesday, the best performer in the FTSE 250.
The pharmaceutical company, which was spun-off by consumer goods group Reckitt Benckiser Group PLC in late 2014, said its pretax profit in the first quarter was USD102 million, compared to USD165 million a year earlier.
Net revenue for the company fell to USD251 million from USD281 million a year earlier, while selling, distribution and administrative expenses rose to USD92 million from USD77 million, and research and development spending rose to USD20 million from USD16 million.
The rise in operating costs was as a result of operating as a standalone company, as well as USD2 million in exceptional costs related to its de-merger from Reckitt Benckiser. Research and development costs were higher due to two phase III trials running during the quarter.
In the US revenue fell 9%, as market growth was offset by lower market share. US market growth in the first quarter was in the low double digits, the company said, boosted in part by the Affordable Care Act, commonly known as 'Obamacare'. Indivior's share of the Suboxone Film market was 59% in the quarter, down from 64% a year earlier, while volumes sold in the US rose year-on-year.
In the Rest of the World revenue fell 19%, hampered by the strength of the dollar and continuing price constraints from austerity measures and forced switching to generics in Europe, which offset growth in Australia.
The company's Suboxone Film heroin-replacement treatment has faced increasing generic competition, but Indivior noted that branded competitors have had a "limited impact" on the market so far.
Looking towards its second quarter, Indivior said the level of impact to date indicates that a steep decline in pricing guided by industry analogues has not yet occurred - but cautioned that estimating exact timing for this decline is difficult.
It still believes that these industry analogues on generic pricing will apply, but said the issue is when, and how severe. As a result, its guidance for the full year may be too cautious, and if the more positive market environment continues, there may be room to reassess its guidance at the time of its half year results, the company said. It expects to announce its interim results on July 29.
"We have enjoyed a good start to the year with first quarter numbers modestly exceeding our plan which anticipated no rapid deterioration in the quarter's trading environment," said Chief Executive Shaun Thaxter.
"In the US, generic tablet pricing has not yet disrupted our market share while branded competitors had very limited impact, although as in the second half of last year, we continued to offer tactical rebates in connection with formulary access for Suboxone Film," Thaxter added.
"In Europe, government austerity measures and price constraints have continued in line with expectation. This overall environment was in line with our plan for the first quarter; if it continues, we may have room to reassess our full-year guidance at the half year," he added.
In a separate statement, the company said the top-line results for its RBP-7000 drug for the treatment of schizophrenia were positive, with clinically significant reductions in the symptoms of acute schizophrenia seen over an eight-week treatment period.
Based on the success of the trial it expects to submit a new drug application to the US Food and Drug Administration for potential approval in 2017.
"With these positive phase 3 data in hand, we are moving forward expeditiously to complete the open-label long-term assessment of the safety and tolerability of RBP-7000," said Chief Scientific Officer Christian Heidbreder in a statement.
By Sam Unsted; [email protected]; @SamUAtAlliance. Additional reporting by Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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