Indivior Sees FY 2018 Net Revenue and Adjusted Net Income Below Previous Expectations

Slough, UK, 11 July 2018 – Indivior PLC (LON: INDV) (“Indivior” or the “Company”) today announced that its previous FY 2018 financial guidance (net revenue: $1,130m - $1,170m; adjusted net income: $280m - $320m) is no longer valid based on recent US market developments for SUBOXONE® and early uptake levels of SUBLOCADE™.

US Market Developments:

• Generic Film Entry: Further to Dr. Reddy’s Laboratories’ (DRL) FDA approval and launch announcement on June 15th , Indivior is now seeing the market impact of DRL’s generic buprenorphine/naloxone sublingual film sold into the U.S. market prior to the granting of a temporary restraining order (TRO). Indivior does not know the exact quantity of product sold by DRL prior to the issuance of the TRO. However, the Company has observed recent accelerated market share loss for SUBOXONE® of two-and-half percentage points, to 52 percent, in the most recent weekly data(1) . While the eventual impact could be materially higher depending on DRL’s final stocking levels, Indivior currently anticipates the FY 2018 net revenue impact from this level of share loss to be $25m.
   
• SUBOXONE® Film Channel Mix: The level of discounting of generic tablets has now resulted in pricing of 75 to 80 percent below list price. This new level of discounting has further reduced the profitability of the most price sensitive channel (Managed Medicaid), which currently represents the majority of overall growth in the U.S. buprenorphine medication assisted treatment market (BMAT). As a result of the unfavourable mix impact, Indivior is experiencing lower than expected net revenue. The Company estimates a FY 2018 minimum net revenue impact of $50m from this market development.

SUBLOCADE™ launch:

• Indivior continues to be greatly encouraged by positive patient and physician feedback and earlier-than-expected market access, now standing at over 55 percent of covered US lives in this early stage of the launch. However, the Company is continuing to experience some friction in the new distribution and reimbursement model, which is having an impact on physician willingness to prescribe at higher levels. Indivior is working diligently to address the issues and has continued to invest in process improvements. While the progress from the Company’s actions is recognizable, improvement in patient throughput remains gradual. As a result, Indivior expects FY 2018 SUBLOCADE™ net revenue to be in the range of $25m to $50m, which is approximately $50m lower than its internal expectations. Indivior remains confident in achieving peak sales of at least $1 billion-plus in annual net revenue.

At this time, Indivior cannot reliably provide updated FY 2018 net revenue and adjusted net income guidance until the impact of DRL’s launch is better understood. The Company expects that this will be no later than its third quarter results announcement, currently scheduled for November 1st. Indivior also continues to await a ruling from the U.S. District Court for the District of New Jersey on Indivior’s motion for a preliminary injunction (PI) against DRL, which would prohibit DRL from selling or offering for sale its generic buprenorphine/naloxone sublingual film product pending the outcome of recently filed patent infringement litigation against DRL related to Indivior’s U.S. Patent No. 9,931,305 (the ‘305 patent).

Shaun Thaxter, CEO of Indivior commented:
“Given the swift and material change in US market dynamics as well as the early-stage reimbursement and distribution model challenges we are experiencing with SUBLOCADE™, we are removing our FY 2018 net revenue and net income guidance.

We are continuing to monitor US market developments to better gauge DRL’s launch impact. We know that they are skilled in rapid distribution in quantity and, as such, there is a range of uncertainty around the amount of product they were able to ship before the temporary restraining order (TRO) was granted by the court. We are making progress in overcoming SUBLOCADE’s early stage challenges and continue to expect to deliver peak net revenue of $1billion-plus.

We are looking at cost saving opportunities, initially targeting at least $25m in cost savings in 2018, to partially offset the financial impact of these developments. We will provide more details on the SUBLOCADE™ launch, cost saving initiatives and overall business performance with our 2018 half-year results presentation on July 25th .”

About Indivior

Indivior is a global specialty pharmaceutical company with a 20-year legacy of leadership in patient advocacy and health policy while providing education on evidence-based treatment models that have revolutionized modern addiction treatment. The name is the fusion of the words individual and endeavour, and the tagline “Focus on you” makes the Company’s commitment clear. Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of opioid dependence treatments, Indivior has a strong pipeline of product candidates designed to both expand on its heritage in this category and address other chronic conditions and co-occurring disorders of addiction, including alcohol use disorder and schizophrenia. Headquartered in the United States in Richmond, VA, Indivior employs more than 900 individuals globally and its portfolio of products is available in over 40 countries worldwide. Visit www.indivior.com to learn more.

Forward-Looking Statements

This announcement contains certain statements that are forward-looking and which should be considered, amongst other statutory provisions, in light of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. By their nature, forward-looking statements involve risk and uncertainty as they relate to events or circumstances that may or may not occur in the future. Actual results may differ materially from those expressed or implied in such statements because they relate to future events. Forward-looking statements include, among other things, statements regarding the Indivior Group’s financial guidance for 2018 and its medium- and long-term growth outlook, its operational goals, its product development pipeline and statements regarding ongoing litigation.

Various factors may cause differences between Indivior's expectations and actual results, including: factors affecting sales of Indivior Group’s products; the outcome of research and development activities; decisions by regulatory authorities regarding the Indivior Group’s drug applications; the speed with which regulatory authorizations, pricing approvals and product launches may be achieved; the outcome of post-approval clinical trials; competitive developments; difficulties or delays in manufacturing; the impact of existing and future legislation and regulatory provisions on product exclusivity; trends toward managed care and healthcare cost containment; legislation or regulatory action affecting pharmaceutical product pricing, reimbursement or access; claims and concerns that may arise regarding the safety or efficacy of the Indivior Group’s products and product candidates; risks related to legal proceedings, including the ongoing investigative and antitrust litigation matters; the Indivior Group’s ability to protect its patents and other intellectual property; the outcome of patent infringement litigation relating to Indivior Group’s products, including the ongoing ANDA lawsuits; changes in governmental laws and regulations; issues related to the outsourcing of certain operational and staff functions to third parties; uncertainties related to general economic, political, business, industry, regulatory and market conditions; and the impact of acquisitions, divestitures, restructurings, internal reorganizations, product recalls and withdrawals and other unusual items.

Media Contacts

US
IndiviorMediaContacts@indivior.com
+1 804-594-0836

UK
Tulchan Communications
+44 207-353-4200

Investor Contact
Jason Thompson
Indivior Vice President, Investor Relations
+1 804-402-7123
Jason.Thompson@indivior.com