H1 2016 Indivior Financial Results

This announcement contains inside information.

Half Year Financial Highlights

• H1 net revenue at $531m (H1 2015: $517m) increased 3% versus prior year with strong market growth and increased market share offset by higher rebates, in connection with formulary access in the US, versus prior year. Net revenue at constant FX grew by 3%.
• H1 operating profit of $198m (H1 2015: $230m), reflected higher net revenues, and the expected higher operating costs and $14m exceptional costs for strategic initiatives in preparation for the possibility of a negative ANDA trial outcome.
• H1 net income was $107m (H1 2015: $144m) after net financing costs of $26m (H1 2015: $31m) and tax rate of 38% (H1 2015: 28%) including exceptional tax items of $14m related to unresolved tax matters.
• Cash balance at half year of $577m. Net debt at half year $5m (vs. Year End 2015: $174m).

Half Year Operating Highlights

• US market growth in H1 2016 continued to be mid to high single digit percentage. Indivior welcomes recent legislation to widen access to medication assisted treatment in the USA.
• Suboxone® Film market share was 61% (compared to 60% in H1 2015).
• Positive ruling in the ANDA litigation against Actavis & Par confirms Company’s ongoing confidence in its intellectual property protection for Suboxone® Film.
• New product pipeline continuing to progress. Readouts on major clinical trials are due in the next few months; Buprenorphine Monthly Depot (RBP‐6000) Phase III efficacy study top‐line in Q3; Risperidone Monthly Depot (RBP‐7000) Phase III Safety Extension in Q4; Arbaclofen Placarbil for treatment of alcohol use discorder, Phase IIA Dosing Study found it to be safe and well tolerated up to cap target dose but with high inter‐individual PK variability observed.
• Cost reduction and benchmarking project initiated to optimize new organisation and structure.
• Indivior PLC has announced intention to list its ADRs in the US, and filed its form 20‐F with SEC.

Outlook

• Full year guidance today raised to net revenue in a range of $1,000m to $1,030m (previously $945m ‐ $975m) and adjusted net income (excluding exceptionals) of $180m to $200m (previously $155m‐$180m) at constant exchange rates (versus 2015). The guidance recognises current market conditions in the US are continuing into H2, but assumes no deterioration in generic tablet pricing, limited impact of branded competition, and investment of $35m above original assumptions in driving innovations. The Company will update further at Q3 results on November 2nd, 2016.

Comment by Shaun Thaxter, CEO of Indivior PLC

“Our performance this year to date is ahead of our plan.“ commented Shaun Thaxter, CEO of Indivior PLC. “US market growth has continued in mid‐to‐high single digits, while Suboxone® Film share has been strong, driven by a couple of formulary gains and the resilience of its franchise with patients and physicians. This resilience was underlined by the outcome of the first ANDA trial which confirmed the strength of our intellectual property protection for Suboxone® Film. Accordingly we are today raising our full‐year guidance for net revenue to a range of $1,000m to $1,030m and adjusted net income (excluding exceptionals) of $180m to $200m, both at constant exchange. We will update further at Q3 results on November 2nd.“

“At the beginning of the year, I set out our priorities for 2016,“ Shaun Thaxter continued. “I am delighted with the strong progress we have made. Now that we have built a structure and capability that is fit for purpose as a standalone PLC, we are initiating a project in the second half of the year to optimize our organisation, benchmarking costs against appropriate comparators, and looking to optimize our structure.“

“Our pipeline of new, potentially transformative treatments for addiction and co‐morbidities, is on the verge of reporting important trial results which should allow us to file two critical NDAs in the next 12‐18 months; one for our critical Buprenorphine Monthly Depot for opioid dependence, and one for our Risperidone Monthly Depot for treatment of schizophrenia. We continue to look for business development and acquisition opportunities to expand our pipeline and to start diversifying our revenue sources within addiction and closely related areas. We have completed clinical trials for Suboxone® Tablet in China, and plan to file an NDA there which represents a step forward in geographical expansion for our business.“

“Indivior has a unique business model 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, “Indivior therefore warmly welcomes the intensified focus by Government and regulators, through the CARA legislation and HHS final rule, on increasing access to medication assisted treatment for addiction. Statistics suggest that only a fraction of the 2.5 million Americans who suffer from opioid dependence are receiving treatment today. The changes, to allow nurse practitioners and physician assistants to prescribe and to raise the patient cap from 100 to 275 patients for certain qualified physicians, together with the grants provided by CARA, should help accelerate the process of getting more people into treatment, and towards a better quality of life, and can only be good for public health and the economy. We look forward to uniting with stakeholders and healthcare professionals across communities to help implement the comprehensive approach outlined by CARA.“