Indivior : Q3 / YTD 2017 Financial Results...

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Solid YTD 2017 Financial Results and FY 2017 Guidance Reconfirmed

• YTD 2017 net revenue of $828m (YTD 2016: $799m) increased 4% on a reported basis (4% at constant exchange) primarily due to continued strong market growth in the US that was partially offset by generic competition in the most price sensitive US payors (Managed Medicaid) and lower wholesaler stocking activity.
• YTD 2017 operating profit was $308m (YTD 2016: $78m) reflecting higher net revenues and lower R&D and legal expenses. On an adjusted basis, excluding $25m of exceptional items YTD and $237m in the year-ago period, YTD 2017 adjusted operating profit increased 6% to $333m (YTD 2016 adj: $315m).
• YTD 2017 net income was $203m (YTD 2016 net loss: $43m). On an adjusted basis, YTD 2017 net income increased 5% to $216m (YTD 2016 adj: $205m).
• Cash balance at the end of Q3 2017 was $806m (FY 2016: $692m); net cash was $322m (FY 2016: $131m).
• FY 2017 guidance reconfirmed. Net revenue expected to be in a range of $1,090m to $1,120m and adjusted net income of $265m to $285m assuming no material changes to current market conditions, excluding exceptional items and at constant FX. Guidance includes $40m to $60m of pre-launch investments for late stage pipeline assets.

YTD 2017 Operating Highlights

• US market growth in 2017 continues at low double-digit percentage levels.
• Suboxone® Film market share averaged 58% in YTD 2017 (YTD 2016: 61%), exiting Q3 2017 at 56% primarily due to ongoing generic competition in the most price sensitive US payors (Managed Medicaid).
• RBP-6000 buprenorphine monthly depot for the treatment of opioid use disorder (OUD) recommended for approval at joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on October 31st; November 30th PDUFA (Prescription Drug User Fee Act) date.
• New drug application (NDA) submitted September 28th for RBP-7000 risperidone monthly depot for the treatment of schizophrenia.
• Indivior initiated the appeals process against Dr Reddy's after the US District Court for the District of Delaware found the asserted claims of Patent Nos. '150, '514 and '497 valid but not infringed by Dr. Reddy's proposed generic buprenorphine/naloxone film. As of November 2nd, 2017, FDA has not announced that it has granted tentative or final marketing authorization to any generic buprenorphine/naloxone film, except for Actavis's proposed generic version of buprenorphine/naloxone film granted tentative approval on October 24th, 2017, which was enjoined from launch until April 2024 by the Delaware court ruling of 2016.
• Indivior took additional actions to secure its intellectual property position by reaching a settlement with Mylan and asserting its new Orange Book-listed patent covering Suboxone® Film, US Patent No. 9,687,454 (the ''454 patent').
• The Group continues in discussions with the Department of Justice about a possible resolution to its investigation. Please see pages five to eight for a comprehensive Litigation Update.

Shaun Thaxter, CEO of Indiviorcommented:

'Continued solid execution in the quarter against a strong US market backdrop leaves us on track to meet our FY 2017 guidance, which we increased significantly with our H1 2017 results. We have also taken important steps to protect our intellectual property rights by initiating our appeal in the Dr Reddy's ANDA litigation, settling with Mylan, including termination of their IPR, and asserting our recently-granted '454 patent. Most importantly, we have continued to progress our pipeline with the successful NDA submission of RBP-7000 in schizophrenia and, in recent days, by the endorsement of the FDA's Psychopharmacologic Drugs Advisory and Drug Safety and Risk Management Advisory Committees for RBP-6000, our potentially transformational product for the treatment of opioid use disorder. We are finalizing our launch plans and are working closely with our third-party manufacturing partners to ensure appropriate delivery of product to enable our target launch in Q1 2018. We are looking forward to the PDUFA date of November 30th.'

To view the full Press Release - Indivior Q3 Financial Results