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February 18, 2021

FY 2020 Financial Results Announced. FY 2021 Guidance Introduced.

^*Adjusted (Adj.) basis excludes the impact of exceptional items as referenced in Notes 3 and 4. NM: Not Meaningful.

FY 2020 Highlights

·    Net revenue (NR) of $647m (-18% vs. FY 2019) mainly reflected SUBOXONE® (buprenorphine and naloxone) Film share loss, partly offset by higher NR from SUBLOCADE® (buprenorphine extended-release) injection.

·    Reported operating loss of $156m. Exceptional costs of $244m primarily relate to litigation settlements - see Notes 3 and 4. Adj. operating profit of $88m (-56% vs. adj. FY 2019) mainly due to lower NR and higher SG&A expense from growth investments in SUBLOCADE and legal defense costs primarily due to resolving the Department of Justice (DOJ) matter.

·    Reported net loss of $148m. Adj. net income of $59m (-66% vs. adj. FY 2019), reflecting lower operating profit and net finance expense (versus net finance income in FY 2019).

·    Cash of $858m (-$202m vs. FY 2019), following $103m payment, including interest, related to DOJ resolution. Net cash of $623m

(-$198m vs. FY 2019).

Operating Highlights

·    FY 2020 SUBLOCADE NR of $130m (+81% vs. FY 2019) and Q4 2020 NR of $39m (+18% vs. Q3 2020); strong growth from the Organized Health Systems (OHS) channel, despite COVID-19 impact on new patient enrolments. FY 2020 units dispensed were approx. 127,000* (+115% vs. FY 2019); Q4 2020 units dispensed were approx. 40,100* (+14% vs. Q3 2020).

·    PERSERIS® (risperidone) extended-release injection NR of $14m (+133% vs. FY 2019).

·    SUBOXONE® Film share averaged 21% in FY 2020 (FY 2019: 32%) and exited FY 2020 at 21% (FY 2019 exit share: 24%).

·    Completed strategic alignment which is expected to reduce the Group's underlying operating expense base (SG&A + R&D) by $60m to $70m (before reinvestment), while accelerating its growth strategy for SUBLOCADE with increased investment behind further penetrating Organized Health Systems (OHS) and supporting its strong commitment to integrity and compliance.

FY 2021 Guidance Highlights

Base case NR guidance assumes the operating backdrop will improve in H2 2021, as COVID-19 pandemic restrictions impacting in-person healthcare practitioner access subside and healthcare systems approach normality. Detailed guidance, including potential risks are provided on Page 2.

·    Total base case FY 2021 NR up to $625m; SUBLOCADE NR of $185m to $210m; PERSERIS NR of $17m to $20m.

‒     Downside case if COVID-19 pandemic restrictions persist in H2 2021: Total NR of $565m; SUBLOCADE NR of $170m; PERSERIS NR of $15m.

·    Mid- to high-single digit percentage point decline in FY 2021 adj. gross margin; recovery to mid-80's rate in 2022.

·    Adj. OPEX (SG&A+R&D) of $420m to $440m, mainly reflecting incremental investment in US long-acting injectables.

·    Positive adj. pre-tax income.

Comment by Mark Crossley, CEO of Indivior PLC

"Given the challenges of the COVID-19 pandemic, I am delighted both with the solid results that Indivior delivered in FY 2020 and with the dedication to patients displayed by each and every one of our employees. Critically, we materially de-risked the business with resolution of the DOJ and RB matters and we took decisive strategic alignment actions which place Indivior on a clear path towards realizing the transformational potential of SUBLOCADE. We are convinced this important new treatment paradigm represents a significant untapped asset to help patients and society address the desperate condition and widespread epidemic of OUD. Accelerating the growth of SUBLOCADE remains the biggest potential driver of value creation. We are committed to delivering clear, measurable progress in FY 2021 against our SUBLOCADE peak annual net revenue goal of $1 billion+ and organic revenue diversification strategies."

*Includes shipments in ROW geographies

Detailed FY 2021 Guidance

Guidance assumes the operating backdrop, chiefly the ability to accelerate in-person promotion and seek in-patient care, will improve in H2 2021 as COVID-19 pandemic restrictions subside and healthcare systems approach normality.

·    Total base case FY 2021 NR up to $625m; SUBLOCADE NR of $185m to $210m; PERSERIS NR of $17m to $20m

·    In a downside scenario in which the operating backdrop continues to be adversely impacted by pandemic restrictions through H2 2021, Indivior believes total net revenue for FY 2021 could be adversely impacted by up to $60m. On this basis, total net revenue could be approximately $565m with SUBLOCADE and PERSERIS net revenue of approximately $170m and $15m, respectively.

·    Mid- to high-single digit decline in FY 2021 adj. gross margin primarily due to current product and regional mix; adj. GM expected to return to mid-80's in 2022 as more profitable SUBLOCADE is expected to grow as a proportion of total NR.

·    Adj. OPEX (SG&A+R&D) of $420m to $440m reflecting benefits from completed strategic alignment, partially offset by:

‒     incremental investments for US long-acting injectables (LAIs), fueled by the relative strength in US SUBOXONE Film (the Group may make further LAI growth investments based on continued relative US Film strength); and,

‒     COVID-delayed supply-related projects.

·    Positive adj. pre-tax income.

Operating Review

U.S. Opioid Use Disorder (OUD) Market Update

In FY 2020, growth of the U.S. buprenorphine medication-assisted treatment (BMAT) market was sustained at a low teens percentage rate, underpinned by continued growth in the number of patients receiving treatment and by increased access to treatment. The increased market growth followed implementation of new federal and state government actions in light of the COVID-19 pandemic to facilitate access to medication-assisted treatment (MAT), including counselling, for patients suffering from OUD. For example, the Drug Enforcement Administration (DEA), jointly with the Substance Abuse and Mental Health Services Administration (SAMHSA), is continuing to allow healthcare providers to initiate and continue buprenorphine treatment by telemedicine.

Underlying market growth has also benefited from increased overall public awareness of the opioid epidemic and approved treatments, as well as from regulatory and legislative changes introduced prior to the COVID-19 pandemic that have expanded OUD treatment funding and treatment capacity. States increasingly acknowledge that providing treatment brings substantial value to both patients and society and that BMAT is under-utilized.⁽¹⁾

In response, the number of physicians, nurse practitioners and physician assistants who have received a waiver to administer MAT and those able to treat up to the permitted level of 275 patients continued to grow in FY 2020. As a result, there is increasing patient access to treatment. Indivior supports efforts to encourage more eligible HCPs to provide treatment, and the Group continues to resource its compliance capabilities for the growing number of BMAT prescribers and patients.

The Group is uncertain how long the elevated underlying BMAT growth rate will continue, but longer term it believes the growth rate will revert to the previously observed high single-digit to low double-digit percentage growth rate. The Group's focus is to continue to expand access of SUBLOCADE amongst core healthcare practitioners (HCPs) and Organized Health Systems (OHS), in order to ensure availability of this potentially important new treatment option to the estimated 1 million+ patients per month who are prescribed BMAT by HCPs.

(1) JAMA Network Open. 2019;2(6):e196373. Doi:10.1001/jamanetworkopen.2019.6373

Financial Performance: FY 2020 & Q4 2020

Total net revenue in FY 2020 decreased 18% to $647m (FY 2019: $785m). In Q4 2020, total net revenue increased 39% to $185m (Q4 2019: $133m).

FY 2020 U.S. net revenue decreased 23% to $456m (FY 2019: $589m). Growth in the overall U.S. BMAT market was sustained at a low teens percentage rate as discussed above ("U.S. Opioid Use Disorder (OUD) Market Update"), primarily due to strength in government channels. Underlying market strength and SUBLOCADE net revenue growth of 75% to $126m (FY 2019: $72m) were more than offset by SUBOXONE Film share loss and the absence of net revenue contribution from the AGx film program, which was terminated at the end of FY 2019.

In Q4 2020, U.S. net revenue increased 68% to $134m (Q4 2019: $80m). While Q4 2020 net revenue dynamics were substantially the same as those for FY 2020, the comparable year-ago quarter had one-time items that impacted net revenue, chiefly the negative effect of the federal law change enacted October 2019 (HR 4378), which modified the impact of authorized generics (AGx) in determining the mandated rebate amount in government channels for branded SUBOXONE Film. This negatively impacted Q4 2019 net revenue by approximately $47m and the Group subsequently terminated its AGx buprenorphine/naloxone sublingual film program at the end of 2019.

FY 2020 Rest of World (ROW) net revenue decreased 3% to $191m (FY 2019: $196m). In Q4 2020, ROW net revenue decreased 4% to $51m (Q4 2019: $53m). Contribution from SUBLOCADE to ROW net revenue of $4m and $2m are included in the FY 2020 and Q4 2020 periods, respectively. These benefits were more than offset primarily by continued austerity measures in Western European markets.

FY 2020 and Q4 2020 gross margin as reported was 85% and 88%, respectively (FY 2019: 82%; Q4 2019: 68%). Excluding $5m of net exceptional costs of sales related to inventory provisions due to the adverse impact of COVID-19, FY 2020 adjusted gross margin was 86%. The FY 2020 gross margin improvement was primarily due to improved revenue mix from the absence of net revenue from the AGx buprenorphine/naloxone sublingual film program in 2020. The Q4 2020 gross margin increase reflects the impact of federal legislation (HR 4378) discussed above that adversely impacted Q4 2019 gross margin.

FY 2020 SG&A expense as reported were $666m (FY 2019: $414m). FY 2020 SG&A expenses included exceptional costs of $239m, primarily related to resolution of litigation matters. Q4 2020 SG&A expenses as reported were $158m (Q4 2019: $115m). The exceptional costs recorded in Q4 2020 totalled $47m (Q4 2019: exceptional benefit $4m). See Notes 3 and 4 for details on exceptional costs.

On an adjusted basis, FY 2020 SG&A expenses increased 10% to $427m (Adj. FY 2019: $390m). The increase reflects stepped up SUBLOCADE marketing expenses, principally the direct-to-consumer (DTC) campaign, higher legal expenses related to DOJ resolution, partially offset by reduced travel and entertainment due to COVID-19 restrictions. On an adjusted basis, Q4 2020 SG&A expenses declined 7% to $111m (Q4 2019: $119m). The decline in the quarter largely reflects lower marketing expenses, reduced travel and entertainment and impact from completed strategic alignment actions.

FY 2020 and Q4 2020 R&D expenses were $40m and $13m, respectively (FY 2019: $53m; Q4 2019: $17m). The decreases in both periods primarily reflect lower clinical activity and the reprioritization of R&D activities as part of the completed strategic alignment to principally support SUBLOCADE Health Economics and Outcomes Research (HEOR) and post-marketing study commitments for SUBLOCADE and PERSERIS, as well as lower than expected investments for supply-related projects.

FY 2020 operating loss as reported was $156m (FY 2019 op. profit: $178m). Exceptional costs of $244m and $24m are included in the FY 2020 and FY 2019 reported results, respectively. On an adjusted basis, FY 2020 operating profit was $88m (FY 2019 adj. op. profit: $202m). The decline on an adjusted basis primarily reflects lower net revenue and increases in marketing and legal defense costs as detailed above. These items were partially offset by lower R&D and general and administrative expenses.

Q4 2020 operating loss as reported was $9m (Q4 2019 op. loss: $42m). Exceptional costs of $41m and a $4m benefit are included in the Q4 2020 and Q4 2019 reported results, respectively. On an adjusted basis, Q4 2020 operating profit was $32m (Q4 2019: adj. op. loss: $46m). The increase on an unadjusted and adjusted basis primarily reflects the gross profit impact in the year-ago quarter related to legislation that modified the calculation for determining the rebate amount in government channels for SUBOXONE Film.

FY 2020 net finance expense was $17m (FY 2019 income: $2m). The net expense primarily reflects lower interest income on the Group's cash balance due to lower interest rates versus the year-ago period and increased finance expense incurred related to the DOJ liability.

FY 2020 reported total tax benefit was $25m, an effective tax rate of 14% (FY 2019 tax charge: $46m, 26% rate). Excluding the $37m tax benefit on exceptional items in FY 2020, total tax expense was $12m, an effective tax rate of 17% (FY 2019: $28m, 14% rate). Q4 2020 reported total tax benefit was $1m, representing an effective tax rate of 7% (Q4 2019 tax charge: $13m, 31% rate). Excluding the $2m tax benefit on exceptional items in Q4 2020, the effective tax rate was 4% (Q4 2019 tax benefit $9m, 20%).

FY 2020 reported net loss was $148m (FY 2019 net income: $134m). Excluding the $207m after-tax impact from exceptional items, FY 2020 adjusted net income was $59m (Adj. FY 2019: $176m). The decline in net income on an adjusted basis primarily reflects lower net revenue, increased operating expenses (primarily marketing and legal defense costs) and net finance expense (versus FY 2019 net finance income).

Reported Q4 2020 net loss on a reported basis was $13m. (Q4 2019 reported net loss: $55m). Excluding the $39m after-tax benefit from exceptional items, Q4 2020 adjusted net income was $26m. Q4 2019 net loss was $55m and adjusted net loss was $37m, reflecting the increased gross profit versus the year-ago quarter related to legislation that modified the calculation for determining the rebate amount in government channels for SUBOXONE Film.

Loss per share on a diluted basis was 20 cents in FY 2020 and earnings per share of 8 cents on an adjusted diluted basis (FY 2019: earnings per share of 18 cents on a diluted and 23 cents on adjusted diluted basis). In Q4 2020, loss per share on a diluted basis was 2 cent and earnings per share of 3 cents on an adjusted diluted basis (Q4 2019: loss per share of 8 cents on a diluted and 5 cents on an adjusted diluted basis).

Balance Sheet & Cash Flow

FY 2020 December 31, 2020 cash and cash equivalents were $858m, a decrease of $202m versus the $1,060m at year-end 2019. Borrowings, including issuance costs, were $235m at December 31, 2020 (FY 2019: $239m). As a result, net cash was $623m at the end of Q4 2020 (FY 2019: $821m), a $198m decrease over the twelve-month period. The change was primarily driven by a payment to the DOJ for $103m (including interest) and the change in net working capital.

Net working capital (inventory, trade receivables and other current assets, less trade and other payables) was negative $202m at the end of 2020 versus negative $323m at the end of 2019. The $121m change over the period was primarily driven by a decrease in sales returns and rebates in the U.S. within payables and a reduction in accrual levels.

Cash used by operating activities in FY 2020 was $148m (FY 2019 cash generated: $128m), representing an increased use of cash of $276m primarily due to lower revenues, timing of payments of sales rebates/other payables and payment to the DOJ for $103m (including interest). Net cash outflow from operating activities was $193m in FY 2020 (FY 2019 net cash inflow: $151m) reflecting the lower cash from operating activities and cash tax payments in FY 2020 versus cash tax received in FY 2019.

FY 2020 cash outflow from investing activities was $4m (FY 2019: $2m). The current year outflows related to the purchase of property, plant and equipment and the prior year outflows relate to the purchase of property, plant and equipment offset by proceeds from the disposal of intangible assets.

FY 2020 cash outflow from financing activities was $10m (FY 2019: $13m), reflecting the principal portion of lease payments and the quarterly repayment on the term loan facility partially offset by proceeds from issuance of shares to satisfy the vesting of options under an employee stock purchase plan.

R&D / Pipeline Update

Indivior's quarterly R&D and pipeline update may be found at: http://www.indivior.com/research-and-development/.

Risk Factors Update

The Board of Directors oversees the approach to risk management and ensures that the principal risks, including those that would threaten the Group's business model, future performance or viability, are effectively managed and/or mitigated. While the Group aims to identify and manage such risks, no risk management strategy can provide absolute assurance against loss.

Set out below are what the Group considers to be the principal risks that could cause the Group's business model, future performance, and solvency or liquidity to differ materially from expected and historical results. Additional risks, not listed here, that the Group cannot presently predict or does not believe to be equally significant, may also materially and adversely affect the Group's business, results of operations and financial position. The principal risks and uncertainties are not listed in order of significance.

Business Operations

The Group's operations rely on complex processes and systems, strategic partnerships, as well as specially qualified and high performing personnel to develop, manufacture and sell our products. Failure to continuously maintain operational and compliance processes and systems as well as to retain and/or recruit qualified personnel could adversely impact products availability and patient health, and ultimately the Group's performance and financials. Additionally, an ever evolving regulatory, political, and technological landscape requires that we have the right priorities, capabilities, and structures in place to successfully execute on our business strategy and adapt to this changing environment.

COVID-19 Pandemic - The persistence of the COVID-19 pandemic and the ongoing government measures to address the global pandemic continue to create a very challenging business environment for companies across industries worldwide and therefore related risks to the Group's business and operations. In response to COVID-19, the Group has established an agile cross-functional response structure; and implemented a number of mitigation and contingency actions to help maintain the functioning of operations across the organization, supply of all products to our patients, and the welfare of our employees. The Group continuously monitors the potential impact on the health and well-being of our employees as well as the workforce of our key third parties, which ultimately may impact our operations. Furthermore, given the remote working environment, the Group continues to closely monitor cybersecurity threats and the overall operating effectiveness of the monitoring and control activities. Given the evolving and dynamic nature of the COVID-19 pandemic, and uncertainty surrounding the duration of measures designed to mitigate its spread, including the vaccination of the population or attainment of herd immunity, the impact on the Group's operations and financial position is highly uncertain and cannot be predicted with confidence. COVID-19 related developments are under constant review to ensure our mitigation and contingency actions are appropriate, proportionate, and as effective as possible. However, despite the measures the Group has taken, if the pandemic adversely affects Indivior's operations and/or performance, it will have a heightened effect on many of the risks impacting the Group, including its business operations.

The manufacturing of our SUBOXONE and SUBUTEX tablets for all of our European markets is performed by a third-party contract manufacturer located in the UK. The Group has been proactive in taking appropriate actions since the Brexit referendum, including changes to logistics, shipping, and quality testing and release processes, as well as transfer of regulatory licenses and additional inventory builds. Uncertainties due to the operational impact of the recently signed Trade and Cooperation Agreement between the UK and the European Union (EU) remain a risk closely monitored as it impacts various areas of the Group, including Operations, Regulatory, Supply Chain, and Quality.

Product Pipeline, Regulatory and Safety

The development and approval of the Group's products is an inherently risky and lengthy process requiring significant financial, research and development resources, and strategic partnerships. Complex regulations with strict and high safety standards govern the development, manufacturing, and distribution of our products. In addition, strong competition exists for strategic collaboration, licensing arrangements, and acquisition targets. Patient safety depends on our ability to perform robust safety assessment and interpretation to ensure that appropriate decisions are made regarding the benefit/risk profiles of our products. Deviations from these quality and safety practices could impact patient safety and market access, which can have a material effect on the Group's performance and prospects.

COVID-19 Pandemic - The COVID-19 pandemic has negatively impacted our R&D operations, specifically trial patient enrolments and limited chemistry, manufacturing & controls (CMC) operations, and therefore caused certain delays in conducting clinical and/or CMC studies internally and/or at our third-party partners.

Commercialization

Successful commercialization of our products is a critical factor for the Group's sustained growth and robust financial position. Launch of a new product involves substantial investment in marketing, market access and sales activities, product stocks, and other investments. Certain factors, if different than anticipated, can significantly impact the Group's performance and position. These factors include: HCP/Patient adoption and adherence; generic and brand competition; pricing pressures; private and government reimbursement schemes and systems; negotiations with payors; erosion and/or infringement of intellectual property (IP) rights; and political and socioeconomic factors.

COVID-19 Pandemic - The pandemic has resulted in overall fewer patient visits to healthcare provider offices for non-COVID-19 reasons or essential treatments, as patients become unable or unwilling to make visits due to overburdened healthcare systems or elect to have remote consultations (telehealth) with their providers. As a result, in Q2 2020, the Group observed a rapid decline in new US patient enrolments followed by a modest improvement in Q3 compared to Q2, and continued growth in Q4 compared to Q3. The pandemic has also resulted in safety concerns, quarantines, or other travel restrictions for patients. Furthermore, even though the Group has developed remote (digital) meeting capability with healthcare providers, the Group's commercial organization is still only able to engage in-person with a limited number of healthcare professionals (HCPs) and Organized Health Systems (OHS). Although COVID-19 has not significantly impacted the Group's overall operating results and financial position to date, a potential enduring and/or significant decline in patient enrolments and on the patient journey, and the inability to effectively engage with HCPs and OHS would have a negative impact on the Group's financial results in future periods.

Governments across the world are considering and taking actions to lower drug prices. In the US, there is bi-partisan support for drug pricing reforms at both federal and state levels, which include potential legislative and regulatory actions to encourage the import of drugs, to price drugs according to a defined international pricing reference, to encourage more competition, and to undertake other initiatives. These, together with federal and state government fiscal constraints resulting from the COVID-19 pandemic which constrain public benefit health programs, pose direct and indirect downward pressure risk on drug prices. The Group continues to monitor potential legislative and regulatory changes and their impacts, advocating for the Group's products based on scientific studies and patient-centered outcomes. However, certain potential legislative and regulatory drug pricing changes could have an adverse impact on the Group's financial performance and results in the future.

Economic and Financial

The pharmaceutical business includes inherent risks and uncertainties, requiring the Group to make significant financial investments to develop and support the success of our product portfolio. Generating cash flow from our approved products, together with external financing, sustains our financial position, allows development of new products, and funds business growth. Realizing value on those investments is dependent upon regulatory approvals, market acceptance (including pricing reimbursement levels), strategic partnerships, competition, and legal developments. Unfavorable outcome from resolutions of legal proceedings, impacts from the COVID-19 pandemic, and/or changes in government pricing regulations could negatively impact our operating results and financial position. Together with potential pressure on our level of net working capital, our ability to comply with our debt covenants could be negatively impacted. As a global business, we are also subject to political, economic, and capital markets changes.

Supply

The manufacturing and supply of our products are highly complex and rely on a combination of internal manufacturing capabilities and third parties for the timely supply of our finished drug and combination drug products. The Group uses third parties, including contract manufacturing organizations (CMOs), to manufacture, package and distribute our products. The manufacturing of oral solid dose, film products and aseptically filled injectables is subject to stringent global regulatory, quality and safety standards, including Good Manufacturing Practice (GMP). Delays or interruptions in our supply chain and/or product quality failures could significantly disrupt patient access, adversely impact the Group's financial performance and lead to product recalls and/or potential regulatory actions against the Group along with potential reputational damages.

COVID-19 Pandemic - The pandemic could adversely impact our broad supply chain (i.e., "supply to patient delivery" process) if we experience a significant absence of our employees and/or employees at our CMOs and vendors due to infection and/or government containment measures. Through on-going management and risk mitigation, internally and with CMOs, the Group has not experienced any significant COVID-19 related disruptions to its supply to patient delivery process through this date.

Legal and Intellectual Property

Our pharmaceutical operations, which include controlled substances, are subject to a wide range of laws and regulations. Perceived or actual noncompliance with these applicable laws and regulations by a pharmaceutical company can result in investigations or proceedings leading to civil or criminal sanctions, fines and/or damages, as well as reputational damages.

Intellectual Property (IP) rights protecting our products may be challenged by external parties, including generic manufacturers. Although we have developed robust patent protection for our products, we are exposed to the risk that courts may decide that our IP rights are invalid and/or that third parties do not infringe our asserted IP rights.

In connection with the agreements to resolve criminal charges and civil complaints related to SUBOXONE Film (see Note 11, Legal Proceedings, to the condensed consolidated financial statements), the Group has specific requirements that are in addition to the Group's pre-existing obligations to comply with applicable laws and regulations associated with its US pharmaceutical operations. The Group is subject to penalties if it fails to fulfill the requirements within the agreements.

The Group is also a party to several civil lawsuits, including ongoing litigation in the Federal FCA Qui Tam suits, and civil antitrust and state claims filed by various plaintiffs. Many of the civil claims concern the same conduct at issue in the Superseding Indictment filed by the DOJ.

The Group is also a defendant in fewer than 400 civil lawsuits brought by various plaintiffs as part of the opioid class action litigation. These cases are at an early stage and are currently stayed.

Unfavorable outcomes from resolutions of these legal proceedings could have a material adverse impact on the Group's business, financial condition and/or operating results.

See Note 11, Legal Proceedings, to the condensed consolidated financial statements for additional information.

Compliance

Our Group operates on a global basis and the pharmaceutical industry is both highly competitive and regulated. Complying with all applicable laws and regulations, including engaging in activities that are consistent with legal and industry standards, and our Group's Code of Conduct are core to the Group's mission, culture, and practices. Failure to comply with applicable laws and regulations may subject the Group to civil, criminal and administrative liability, including the imposition of substantial monetary penalties, fines, damages and restructuring the Group's operations through the imposition of compliance or integrity obligations and have a potential adverse impact on the Group's prospects, reputation, results of operations and financial condition.

As part of the Group's resolution of federal criminal and civil charges related to its legacy products (see Note 11, Legal Proceedings, to the condensed consolidated financial statements for additional information.), the Group has also entered into a Corporate Integrity Agreement (CIA) with HHS-OIG. The five-year CIA requires, among other things, that the Group implement measures designed to ensure compliance with the statutes, regulations, and written directives of U.S. Medicare, U.S. Medicaid, and all other U.S. Federal health care programs, as well as with the statutes, regulations, and written directives of the U.S. Food and Drug Administration. Furthermore, the Group is subject to additional periodic reporting and monitoring requirements related to the Agreements. In addition, the CIA requires reviews by an independent review organization, compliance-related certifications from the Group's executives and certain Board members, and the implementation of a risk assessment and mitigation process. The CIA sets forth specified monetary penalties that may be imposed on a per day basis for failure to comply with the obligations specified in the CIA. The CIA also includes specific procedures under which the Group must notify HHS-OIG if it fails to meet the requirements under the CIA. In the event that HHS-OIG determines the Group to be in material breach of certain requirements of the CIA (including, repeated violations or any flagrant obligations under the CIA, a failure by the Group to report a reportable event and/or take corrective action, a failure to engage and use an independent review organization, a failure to respond to certain requests from HHS-OIG),the Group may be subject to exclusion from participation in the U.S. Federal health care programs, which would have a severe impact on the Group's ability to comply with the financial covenants in the Group's debt facility, maintain sufficient liquidity to fund its operations, pay off its debt in 2022, generate future revenue and ultimately impact the Group's viability.

The Resolution Agreement with the United States Attorney's Office for the Western District of Virginia and Consumer Protection Branch contains certain requirements, such as reporting obligations and that the Group's CEO (a) certify on an annual basis that, to the best of the CEO's knowledge, after a reasonable inquiry, the Group was in compliance with the Federal Food, Drug and Cosmetic Act and has not committed health care fraud, or (b) provide a list of all non-compliant activities and steps taken to remedy the activity. The FTC Stipulated Order contains specific notice and reporting requirements over a ten-year period related to certain activities (e.g., product switching conduct, filing of a Citizen Petition). The Group is subject to contempt prosecution if it fails to comply with any terms of the Resolution Agreement.

The Group's Annual Report for the 2020 financial year will contain additional details on these principal business risks. 

Exchange Rates

The average and period end exchange rates used for the translation of currencies into U.S. dollars that have most significant impact on the Group's results were:

 Webcast Details

There will be a live webcast presentation at 12:00 GMT (7:00 am EST) hosted by Mark Crossley, CEO. The details are below. All materials will be available on the Group's website prior to the event at www.indivior.com.

Webcast link:                       https://edge.media-server.com/mmc/p/23dggtiy

For Further Information

Corporate Website            www.indivior.com

This announcement does not constitute an offer to sell, or the solicitation of an offer to subscribe for or otherwise acquire or dispose of shares in the Group to any person in any jurisdiction to whom it is unlawful to make such offer or solicitation.

Forward-Looking Statements

This announcement contains certain statements that are forward-looking. By their nature, forward-looking statements involve risks and uncertainties 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 2020, if any, and its medium- and long-term growth outlook, its operational goals, its product development pipeline and statements regarding ongoing litigation and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions.

Various factors may cause differences between Indivior's expectations and actual results, including, among others (including those described in the risk factors described in the most recent Indivior PLC Annual Report and in subsequent releases): factors affecting sales of Indivior Group's products and financial position; the outcome of research and development activities; decisions by regulatory authorities regarding the Indivior Group's drug applications or authorizations; the speed with which regulatory authorizations, pricing approvals and product launches may be achieved, if at all; the outcome of post-approval clinical trials; competitive developments; difficulties or delays in manufacturing and in the supply chain; disruptions in or failure of information technology systems; 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; challenges in the commercial execution; 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 compliance with the Indivior Group's agreements with the U.S. Department of Justice and with the Office of Inspector General of the Department of Health and Human Services, noncompliance with which could result in potential exclusion from U.S. Federal health care programs; the ongoing investigative and antitrust litigation matters; the opioid national multi-district litigation and securities class action litigation; 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; risks related to the evolving COVID-19 pandemic and the potential impact of COVID-19 on the Indivior Group's operations and financial condition, which cannot be predicted with confidence; 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.

Consequently, forward-looking statements speak only as of the date that they are made and should be regarded solely as our current plans, estimates and beliefs. You should not place undue reliance on forward-looking statements. We cannot guarantee future results, events, levels of activity, performance, or achievements. Except as required by law, we do not undertake and specifically decline any obligation to update, republish or revise forward-looking statements to reflect future events or circumstances or to reflect the occurrences of unanticipated events.

SUBOXONE® (BUPRENORPHINE AND NALOXONE) SUBLINGUAL FILM (CIII)

Indication

SUBOXONE^® (buprenorphine and naloxone) Sublingual Film (CIII) is a prescription medicine indicated for treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.

Treatment should be initiated under the direction of healthcare providers qualified under the Drug Addiction Treatment Act.

Important Safety Information

Do not take SUBOXONE Film if you are allergic to buprenorphine or naloxone as serious negative effects, including anaphylactic shock, have been reported.

SUBOXONE Film can be abused in a manner similar to other opioids, legal or illicit.

SUBOXONE Film contains buprenorphine, an opioid that can cause physical dependence with chronic use. Physical dependence is not the same as addiction. Your healthcare provider can tell you more about the difference between physical dependence and drug addiction. Do not stop taking SUBOXONE Film suddenly without talking to your healthcare provider. You could become sick with uncomfortable withdrawal symptoms because your body has become used to this medicine.

SUBOXONE Film can cause serious life-threatening breathing problems, overdose, and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other medications that act on the nervous system (i.e., sedatives, tranquilizers, or alcohol). It is extremely dangerous to take nonprescribed benzodiazepines or other medications that act on the nervous system while taking SUBOXONE® Film.

You should not drink alcohol while taking SUBOXONE Film, as this can lead to loss of consciousness or even death.

Death has been reported in those who are not opioid dependent.

Your healthcare provider may monitor liver function before and during treatment.

SUBOXONE Film is not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment. However, SUBOXONE® Film may be used with caution for maintenance treatment in patients with moderate hepatic impairment who have initiated treatment on a buprenorphine product without naloxone.

Keep SUBOXONE Film out of the sight and reach of children. Accidental or deliberate ingestion of SUBOXONE® Film by a child can cause severe breathing problems and death.

Do not take SUBOXONE Film before the effects of other opioids (e.g., heroin, hydrocodone, methadone, morphine, oxycodone) have subsided as you may experience withdrawal symptoms.

Injecting the SUBOXONE Film product may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.

Before taking SUBOXONE Film, tell your healthcare provider if you are pregnant or plan to become pregnant. If you are pregnant, tell your healthcare provider as withdrawal signs and symptoms should be monitored closely and the dose adjusted as necessary. If you are pregnant or become pregnant while taking SUBOXONE Film, alert your healthcare provider immediately and you should report it using the contact information provided below.

Opioid‐dependent women on buprenorphine maintenance therapy may require additional analgesia during labour.

Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy, whether that use is medically authorized or illicit. Unlike opioid withdrawal syndrome in adults, NOWS may be life-threatening if not recognized and treated in the neonate. Healthcare professionals should observe newborns for signs of NOWS and manage accordingly.

Before taking SUBOXONE Film, talk to your healthcare provider if you are breastfeeding or plan to breastfeed your baby. The active ingredients of SUBOXONE Film can pass into your breast milk. You and your healthcare provider should consider the development and health benefits of breastfeeding along with your clinical need for SUBOXONE Film and should also consider any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how SUBOXONE Film affects you. Buprenorphine in SUBOXONE® Film can cause drowsiness and slow reaction times during dose-adjustment periods.

Common side effects of SUBOXONE Film include nausea, vomiting, drug withdrawal syndrome, headache, sweating, numb mouth, constipation, painful tongue, redness of the mouth, intoxication (feeling lightheaded or drunk), disturbance in attention, irregular heartbeat, decrease in sleep, blurred vision, back pain, fainting, dizziness, and sleepiness.

This is not a complete list of potential adverse events associated with SUBOXONE Film. Please see full Prescribing Information www.suboxoneREMS.com.

for a complete list.

To report pregnancy or side effects associated with taking SUBOXONE Film, please call 1-877-782-6966. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information about SUBOXONE Film, SUBOXONE (buprenorphine and naloxone) Sublingual Tablets (CIII), or SUBUTEX^® (buprenorphine) Sublingual Tablets (CIII), please see the respective full Prescribing Information and Medication Guide at www.suboxoneREMS.com.

SUBLOCADE® (BUPRENORPHINE EXTENDED-RELEASE) INJECTION FOR SUBCUTANEOUS USE (CIII)

INDICATION AND HIGHLIGHTED SAFETY INFORMATION

INDICATION

SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days.

SUBLOCADE should be used as part of a complete treatment plan that includes counselling and psychosocial support.

HIGHLIGHTED SAFETY INFORMATION

Prescription use of this product is limited under the Drug Addiction Treatment Act.

CONTRAINDICATIONS

SUBLOCADE should not be administered to patients who have been shown to be hypersensitive to buprenorphine or any component of the ATRIGEL® delivery system.

WARNINGS AND PRECAUTIONS

Addiction, Abuse, and Misuse: SUBLOCADE contains buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviours.

Respiratory Depression: Life threatening respiratory depression and death have occurred in association with buprenorphine. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with SUBLOCADE.

Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome is an expected and treatable outcome of prolonged use of opioids during pregnancy.

Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.

Risk of Opioid Withdrawal with Abrupt Discontinuation: If treatment with SUBLOCADE is discontinued, monitor patients for several months for withdrawal and treat appropriately.

Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to and during treatment.

Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patient is clinically stable on transmucosal buprenorphine before injecting SUBLOCADE.

Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect.

ADVERSE REACTIONS

Adverse reactions commonly associated with SUBLOCADE (in ≥5% of subjects) were constipation, headache, nausea, injection site pruritus, vomiting, increased hepatic enzymes, fatigue, and injection site pain.

For more information about SUBLOCADE, the full Prescribing Information including BOXED WARNING, and Medication Guide visit www.sublocade.com.

PERSERIS® (risperidone) for extended-release injectable suspension

INDICATION AND HIGHLIGHTED SAFETY INFORMATION

PERSERIS (risperidone) is indicated for the treatment of schizophrenia in adults.

CONTRAINDICATIONS

PERSERIS should not be administered to patients with known hypersensitivity to risperidone, paliperidone, or other components of PERSERIS.

WARNINGS AND PRECAUTIONS

Cerebrovascular Adverse Reactions, Including Stroke in Elderly Patients with Dementia-Related Psychosis: Increased risk of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack), including fatalities. PERSERIS is not approved for use in patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS): Manage with immediate discontinuation and close monitoring.

Tardive Dyskinesia: Discontinue treatment if clinically appropriate.

Metabolic Changes: Monitor for hyperglycemia, dyslipidemia and weight gain.

Hyperprolactinemia: Prolactin elevations occur and persist during chronic administration. Long-standing hyperprolactinemia, when associated with hypogonadism, may lead to decreased bone density in females and males.

Orthostatic Hypotension: Monitor heart rate and blood pressure and warn patients with known cardiovascular disease or cerebrovascular disease, and risk of dehydration or syncope.

Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood counts (CBC) in patients with a history of a clinically significant low white blood cell count (WBC) or history of leukopenia or neutropenia. Consider discontinuing PERSERIS if a clinically significant decline in WBC occurs in absence of other causative factors.

Potential for Cognitive and Motor Impairment: Use caution when operating machinery.

Seizures: Use caution in patients with a history of seizures or with conditions that lower the seizure threshold.

ADVERSE REACTIONS

The most common adverse reactions in clinical trials (≥ 5% and greater than twice placebo) were increased weight, sedation/somnolence and musculoskeletal pain. The most common injection site reactions (≥ 5%) were injection site pain and erythema (reddening of the skin).

For more information about PERSERIS, the full Prescribing Information including BOXED WARNING, and Medication Guide visit www.perseris.com.

Condensed consolidated income statement

Condensed consolidated statement of comprehensive income/(loss)

The notes are an integral part of these condensed consolidated financial statements.

Condensed consolidated balance sheet

The notes are an integral part of these condensed consolidated financial statements.

Condensed consolidated statement of changes in equity

The notes are an integral part of these condensed consolidated financial statements.

Condensed consolidated cash flow statement

¹Changes in provisions and other liabilities line include $228m of exceptional charges relating to litigation matters offset by the $100m initial payment under the DOJ resolution in 2020. $3m of interest on the DOJ resolution has been recorded in the interest paid line item.

The notes are an integral part of these condensed consolidated financial statements.