INDIVIOR PLC Q1 Financial Results Ahead of Plan. Full Year Guidance Confirmed.

Q1 Financial Highlights

• Net revenue at $258m (Q1 2015: $251m) grew 3%. Constant FX net revenue grew by 4%.
• Operating Profit of $101m (Q1 2015: $115m). Operating Margin of 39%.
• Net income of $50m (Q1 2015: $77m) after tax rate of 36% and exceptional tax of $5m.
• Cash balance at quarter end of $543m. Net debt at quarter end $83m (Year End 2015: $174m).

Q1 Operating Highlights

• US market growth so far in 2016 has been in mid-single digits, compared to the equivalent period last year which was boosted by the impact of the Affordable Care Act.
• Suboxone® Film market share for the quarter was 60% (up from 59% in Q1 2015). Total volume sold in the USA was ahead of the same period last year. Suboxone® Film list price was increased modestly in January 2016, the first price increase since 2012 but this was offset by tactical rebates in connection with formulary access which continued, and by annualisation of prior year rebates, albeit at a lower rate of increase than in 2015.
• New product pipeline progress. Phase III trials of Buprenorphine Monthly Depot continue on track with results of efficacy trial due in Q3. As previously announced on April 28th, the development of the Risperidone Monthly Depot, currently concluding its Phase III safety trial, has been delayed by an external manufacturing issue, which will result in a delay in likely approval until mid-2018. The outcome of the Phase I trial on Buprenorphine Hemiadipate was also announced on April 28th, showing that the trial did not achieve the required PK profile in humans. The outcome of the Phase IIa trial on Arbaclofen Placarbil for treatment of Alcohol Use Disorder is due in Q3 2016.
• Indivior continues to await the outcome of the ANDA trial against Actavis and Par which is expected in Q2.

Guidance

• Full year Guidance for 2016 is again confirmed: net revenue of $945m – $975m and net income in a range of $155m-$180m, excluding exceptional items and at constant exchange rates. This guidance assumes; 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 the strategic decision to reinvest at least an additional $35m in R&D and pre-commercialisation activity for the expected launch of Buprenorphine Monthly Depot for the treatment of Opioid Use Disorder.

Commenting on the results, Shaun Thaxter, CEO of Indivior, said

“We had a good start to the year with Q1 numbers exceeding our plan which anticipated no material deterioration in the trading environment. In the US, generic tablet pricing began to experience some additional discounting but branded competitors had very limited impact although we continued to offer some tactical rebates in connection with formulary access for Suboxone® Film. In January, we took a modest price increase on Suboxone®, our first since 2012.

“Recent proposals from President Obama, HHS and Congress to expand access to medically assisted treatment for opioid dependency are very welcome. Raising the patient cap for appropriately qualified physicians and allowing appropriately qualified nurse practitioners to prescribe would help expand access to care for many untreated opioid dependent patients in the US. We continue to encourage appropriate proposals to be enacted swiftly.

“We made further progress against our key strategic priorities for 2016; our Suboxone® share of 60% in the US is marginally ahead of the exit share for 2015 and reinforces our confidence in the sustainability of Suboxone® Film; the treatment market has grown modestly in the US, but the increased legislative and Governmental attention on the problems of opioid dependency suggest that access to medically assisted treatment should accelerate again as new proposals take effect.

“Our pipeline continues to make progress. Our Buprenorphine Monthly Depot is on track in its Phase III trials with the efficacy trial due to read out in late Q3. This is by far our most important project and it is excellent news that it remains on track for potential approval before the end of 2017, assuming it receives priority review. The delay in the Risperidone Monthly Depot project, due to an external manufacturing issue, is not a fundamental problem, but it will result in a change to our original development timeline. RBP 6300, the oral swallowable capsule of Buprenorphine Hemiadipate, did not achieve the anticipated PK profile in its Phase I trial, demonstrating again the difficulty of developing a swallowable formula of Buprenorphine but we will now evaluate alternative options. In Q3, we will discover much more about the potential of Arbaclofen Placarbil for the treatment of Alcohol Use Disorder, when we get the read-out on the Phase IIa trial.

“We today confirm our financial guidance for the year. Indivior is in good shape for the next phase of its development“.

To view the full Press Release – INDIVIOR PLC Q1 Financial Results Ahead of Plan. Full Year Guidance Confirmed.