Q1 2017 Indivior Financial Results

Q1 Financial Results in line with plan. Full Year Guidance Confirmed.

Q1 Financial Highlights

• Net revenue growth of 3% to $265m (Q1 2016: $258m) primarily reflects strong market growth in the US.
• Operating Profit of $128m (Q1 2016: $101m) primarily reflects lower litigation and R&D expenditures, which due to planned phasing of activity, are expected to increase over the remainder of 2017. In addition, planned incremental investments in 2017 of $40m to $60m related to key pipeline assets are expected to accelerate from Q2 onwards. Operating margin was 48% (Q1 2016: 39%).
• Net income of $80m (Q1 2016: $50m) after tax rate of 32% (Q1 2016: 36% plus exceptional tax of $5m). On an adjusted basis, net income increased 46% to $80m (Q1 2016: $55m adjusted).
• Cash balance at quarter end increased to $729m (Year End 2016: $692m). Net cash at quarter end was $182m (Year End 2016: $131m).

Q1 Operating Highlights

• US market growth of low double-digit percentage levels is in-line with expectations, and was modestly boosted by the impact of the regulatory change to allow qualified physicians to treat up to 275 patients from 100 patients.
• SUBOXONE® Film market share on average for the quarter was 60% (Q1 2016: 60%). Market share at the end of the quarter, however, was 59% primarily due to the loss of a Managed Medicaid account to generic competition. Total volume sold in the US was up despite significant destocking at wholesalers. SUBOXONE® Film list price increased modestly in January 2017, but was offset by tactical rebates as generic and branded discounting continues.
• The NDA for RBP-6000, the monthly depot of buprenorphine for the treatment of opioid use disorder, is on-track and expected to be filed in Q2 2017. The NDA for RBP-7000, the monthly depot of risperidone for the treatment of schizophrenia, is also on-track and expected to be filed in Q4 2017.
• Indivior continues to await the outcome of the trial against Dr. Reddy’s Laboratories (Dr. Reddy’s) on US Patent Nos. 8,017,150, 8,603,514, and 8,900,497; and against Actavis and Par on US Patent No. 8,900,497, which is expected sometime in Q2.
• The Group continues in discussions with the Department of Justice about a possible resolution to its investigation. The Group cannot predict with any certainty whether it will reach ultimate resolution with the Department of Justice or any or all of the other parties, or the ultimate cost of resolving all of the matters. Please see pages five to seven for a complete Litigation Update.

Guidance

• Full year preliminary guidance for 2017 is confirmed: net revenue of $1,050m-$1,080m and net income of $200m-$220m (excluding exceptional items and at constant exchange rates) and assuming no material change to current US market conditions for SUBOXONE® Film. The guidance also reflects planned incremental investments of $40m-$60m related to key pipeline assets that are expected to accelerate from Q2 onwards, as well as litigation and R&D expenditures that are expected to increase over the remainder of 2017.

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

“We are off to a good start to the year. Our Q1 results were in-line with our plan, which assumed no material deterioration in the market environment, and we made progress against key strategic priorities. In the US, SUBOXONE® Film share remains resilient at just under 60% despite ongoing intense competition, particularly in Managed Medicaid. This is a testament to our market leading presence combined with the growing awareness of opioid use disorder as a disease state that is increasingly being helped by legislation and funding at governmental levels. Meanwhile, we continue to turn our energy and resources to Indivior’s future – RBP-6000 (monthly depot of buprenorphine) and RBP-7000 (monthly depot of risperidone). We are on-track to file NDAs for both products with FDA this year and we will invest appropriately to help ensure their successful launch upon approval. Our finances continue to improve with net cash having increased to $182m at the end of Q1, and we are continuing to enhance our compliance capability to keep pace with the expected market growth. We are pleased today to confirm our financial guidance for the current year. Overall, we have made good progress in the quarter and remain focused on our commitment to empowering patients and striving to improve their quality of life by pioneering innovative, quality, accessible and cost effective treatments.”

To view the full Press Release: Q1 2017 Indivior Financial Results