Nine Month Financial Results: Litigation Provision of $220m Booked: Guidance raised

Nine Month Financial Results: Litigation Provision of $220m booked : Guidance raised.

* adjusted basis, excluding impact of exceptional items of $237m in 9m and $223m in Q3.

This announcement contains inside information.

The Company has recorded a charge of $220m in the third quarter of 2016 for the investigative and antitrust litigation matters noted on pages 6-7.  Because these matters are in various stages, Indivior cannot predict with any certainty the ultimate resolution or cost of all of the matters.  The final amount might be materially different from this reserve.

Nine Months Financial Highlights

• Net revenue at $799m (2015: $766m) increased +4% versus prior year due to continuing market growth and slightly higher market share offset by higher rebates, in connection with formulary access in the US, versus prior year and exchange. Net revenue at constant FX increased by 5%.
• Operating profit of $78m (2015: $308m), reflected higher net revenues, offset by higher operating costs as a standalone public company and higher legal costs, and $237m (2015 $7m) of exceptional costs. On an adjusted basis, operating profit was $315m (2015: $315m).
• Net income was a loss of $43m (2015: $191m) after net financing costs of $39m (2015: $47m) and an unadjusted tax rate of 210% (2015: 27%). On an adjusted basis, net income was $205m (2015: $196m) with a tax rate of 26% (2015: 27%).
• Cash balance at period end of $586m. Net cash of $11m (vs. Year End 2015: net debt $174m).

Nine Months Operating Highlights

• US market growth in 2016 year to date continues to be in mid to high single digits with a slight increase in growth in recent months. SUBOXONE® Film market share was 60.5% (2015: 60%), slightly ahead of the end of 2015 share.
• New product pipeline progress. Positive top line results from the Phase III Efficacy study of RBP-6000 (Monthly Depot Buprenorphine) published August 17th, 2016 achieving both primary and secondary endpoints.  Phase III Safety extension study completed Q3 2016.
• The process leading to US listing is temporarily suspended pending clarification of the Company’s position in respect to outstanding litigation and investigations.
• The next round of ANDA trials is due to commence on November 7th with trial against Dr.Reddy, on the Orange Book listed patents and against Actavis, Par and Dr.Reddy on the process patent.

Outlook

• Full year guidance, reflecting faster market growth in the US, is today raised to net revenue in a range of $1,060-$1,075m (previously $1,000m-$1,030m) and adjusted net income in a range of $250m-$265m (previously $180m-$200m), at constant exchange and excluding all exceptional items. The guidance assumes current market conditions continue for the rest of the year and that the effect of accelerated shipments in Q3 in US and Europe do not repeat in Q4.

Comment by Shaun Thaxter, CEO of Indivior PLC

“Our performance this year to date continues to be strong“ commented Shaun Thaxter, CEO of Indivior PLC.  “This is the third consecutive quarter of net revenue growth, with our development reflecting the growth in the market.  Suboxone® Film share has been stable at over 60% this year.“

“As market growth has modestly improved, we are now able to raise our previous guidance for the full year.  This over-delivery against our plan allows us to use a proportion of the over-delivery to reinvest in the long-term organic growth drivers of our business, particularly in pre-launch education and market preparation for the launch of our Monthly Depot of Buprenorphine.  We look forward to giving more insight into these investments at our R&D Day for investors on December 9th.   At the same time, we are continuing with our project to optimize our new organisation and structure.“

“Indivior PLC is focused on empowering patients and striving to improve their quality of life by pioneering innovative, high-quality, accessible and cost effective treatments,“ Shaun Thaxter continued.  “I am pleased with our progress towards realizing our vision and achieving key strategic priorities for 2016.  We continue to demonstrate the resilience of Suboxone® Film in the market place.  Our pipeline is making excellent progress with both our depot products, the Monthly Depot of Buprenorphine which we believe can potentially transform the treatment of opioid use disorder, if approved, and the Monthly Risperidone Depot for treatment of schizophrenia, nearing completion of their clinical development phase and both should be filing NDAs next year.  The Board has recorded a $220m provision in connection with the ongoing litigation and investigation.“

To view the full Press Release:  Nine Month Financial Results: Litigation Provision of $220m Booked: Guidance raised.

There will be a conference call for analysts and investors at 1300hrs UK time (0900hrs Eastern) hosted by Shaun Thaxter, CEO, and Cary Claiborne, CFO.