Indivior Full Year 2015 Financial Results Ahead of Plan. Guidance for 2016 Confirmed.

Full Year Financial Highlights

• Net revenue at $1,014m (2014: $1,115m) declined 9% versus prior year with strong market growth offset by lower average market share and higher rebates, in connection with formulary access in the US, versus prior year and exchange. Net revenue at constant FX declined by 6%.
• Operating profit of $346m (2014: $562m), reflected lower net revenues, and expected higher operating costs as a standalone PLC, including $31m exceptional costs, $15m arising from the establishment of Indivior PLC plus $16m relating to Nasal Naloxone following its non-approval in November and a decision to discontinue further development of the existing formulation.
• Net income was $228m (2014: $403m) after net financing costs of $61m (2014: $1m) and tax rate of 20% (2014: 28%) including $4m exceptional credit.
• Cash balance at period end of $467m after the buy back of $75m of debt in December. Net debt of $174m (vs. FY 2014: $428m).

Full Year Operating Highlights

• US market growth in FY 2015 continued to be in low double digits. Suboxone® Film average market share was 59% (2014: 62%), ahead of the 2014 exit share but below 2014 on average.
• New product pipeline progress. Ongoing Phase 3 trials of Buprenorphine Monthly Depot and Risperidone Monthly Depot on track; Arbaclofen Placarbil for treatment of alcohol use disorders first patient in Phase 2A trial in September 2015; oral swallowable capsule of Buprenorphine Hemiadipate for opioid dependence treatment, last subject out of Phase 1 trial in December 2015.
• ANDA Litigation. Trial in the lawsuits against Actavis and Par completed in December with ruling expected early in Q2.  There are now six ANDA filers seeking FDA approval to market generic Suboxone® Film in the US.

Dividend

• The Board announces a second interim dividend of 9.5 cents a share completing its prospectus indication at the time of the demerger. Following its review of future dividend policy, Indivior PLC does not propose to pay further dividends in the foreseeable future.

Guidance

• Full year 2016 guidance issued in December is confirmed: net revenue of $945m-$975m and net income in a range of $155m-$180m excluding exceptionals and at constant exchange rates assuming; no material change to current market conditions in the US; no disruption to US generic pricing; no generic film entry; and limited impact of branded competition. The guidance also reflects a strategic decision to reinvest up to at least an additional $35m in R&D and pre-commercialisation activity for launch of Buprenorphine Monthly Depot for opioid dependence.

Comment by Shaun Thaxter, CEO of Indivior PLC

“Indivior PLC had an encouraging first year as a public company.“ commented Shaun Thaxter, CEO of Indivior PLC. “We significantly outperformed our financial plan for the year while delivering on the commitments we made at the time of the demerger and successfully managing separation from Reckitt Benckiser Group plc (‘RB‘).  This over-delivery allowed us both to reward shareholders with higher than expected profits and dividend, while using a proportion of the over-delivery to reinvest in the long-term organic growth drivers of our business.   We made significant strategic progress against our objectives for the year. The treatment market in the US grew by double digits, with many new doctors certified, and more patients in treatment.  Suboxone® Film share of 59% in the US demonstrated the resilience of our core business in the face a highly competitive market featuring multiple generic and branded competitors.   Our pipeline of potential treatments for addiction made progress.  The potentially transformational Monthly Depot of Buprenorphine continues its phase 3 trials, our Monthly Risperidone Depot completed its phase III efficacy trial and is continuing its long-term safety extension study as planned, while we commenced trials for our oral swallowable capsule of Buprenorphine Hemiadipate for opioid dependence treatment, and for Arbaclofen Placarbil for treatment of alcohol use disorder.“

“Our belief in the growing medium-term opportunity for Indivior PLC continues to be strong.  Clearly, in the short-term, resolving the multiple ANDA challenges to our core business is our critical focus.  We continue to believe in the strength of our intellectual property portfolio, but we recognise that early certainty will benefit shareholders and the Company.“

“Indivior PLC is otherwise well positioned for 2016.  Our priorities for the year are to continue to help expand access to treatment for the chronic relapsing disease of addiction in the US and globally – the focus at government level on addressing opioid misuse in the US suggests that access to treatment will continue to grow; to build on the resilience of our existing franchise with Suboxone® Film in the US; to continue relentless progress in developing our pipeline of potentially transformational treatments for addiction; to seek appropriate diversification of the business into strategically interesting new sources of revenue and cashflow; and to strengthen the Company’s financial position.  In 2016 we are consciously stepping up investment in R&D and pre-commercialisation projects, and particularly in pre-launch marketing and market preparation for the launch of our Monthly Depot of Buprenorphine.   Our financial guidance for 2016 is based on what we believe to be the likeliest market outcome, and would mean another satisfactory year, delivering profit and cash while taking us another year nearer to the launch of the next generation products from our pipeline.“