Transforming Lives

Annual Report and Accounts 2023

Annual Report and Accounts 2023

Introduction

Strategic Report

Strategic Report

1 Financial Highlights

  1. Introduction
  2. A Global Crisis
  1. Social Stigma
  1. Addressing the Challenge
  1. Our Leading Pipeline
  1. Our Culture
  1. Chair's Statement
  1. Patient Story
  1. Community Advocate Story
  1. Chief Executive Officer's Review
  1. Chief Scientific Officer's Review
  1. Our Business Model
  1. Stakeholder Engagement
  1. 2020 Resolution Agreement Update and Legacy Legal Matters
  2. Our Sustainability Framework
  3. Managing Indivior's Business Responsibly
  1. Non-Financialand Sustainability Information Statement
  1. Financial Review
  1. Legal Proceedings
  1. Risk Management
  1. Viability Statement

Important Cautionary Note Regarding

Forward-Looking Statements

This Annual Report and Accounts contains certain statements that are forward-looking.Forward-looking statements include, among other things, statements regarding the Group's financial guidance including operating and profit margins for 2024 and its medium- and long-term growth outlook; assumptions regarding expected changes in market share and expectations regarding the extent and impact of competition; assumptions regarding future exchange rates; strategic priorities, strategies for value creation, and operational goals; expected future growth and expectations for sales levels for particular products; expected market growth rates, growing normalization of medically assisted treatment for opioid use disorder, and expanded access to treatment; our product development pipeline and potential future products, expectations regarding regulatory approval of such product candidates, the timing of such approvals, and the timing

of commercial launch of such products or product candidates,

and eventual annual revenues of such future products; expectations regarding future production and costs at the Group's Raleigh, North Carolina manufacturing facility; and other statements containing the words "believe," "anticipate," "plan," "expect," "intend," "estimate,"

"forecast," "strategy," "target," "guidance," "outlook," "potential," "project," "priority," "may," "will," "should," "would," "could," "can," "outlook," "guidance," the negatives thereof, and variations thereon and similar expressions.

By their nature, such 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 these forward-looking statements. In particular, our actual results, performance or achievements

or industry results could be affected by, among other things:

the substantial litigation to which we are or may become a party; our reliance on third parties to manufacture commercial supplies of most of our products, conduct our clinical trials and at times to collaborate

Governance

  1. Chair's Governance Statement
  1. Board of Directors
  1. Executive Committee
  1. Corporate Governance
  1. Remuneration At a Glance
  1. Directors' Remuneration Report
  1. Directors' Report
  1. Statement of Directors' Responsibilities

Financial Statements

  1. Independent Auditors' Report
  1. Financial Statements

Additional Information

215 Information for Shareholders

217 Publications and Conference Abstracts

on products in our pipeline; our ability to comply with legal and regulatory settlements, healthcare laws and regulations, requirements imposed by regulatory agencies and payment and reporting obligations under government pricing programs; risks related to the manufacture and distribution of our products, most of which contain controlled substances; market acceptance of our products as well

as our ability to commercialize our products and compete with other market participants; the fact that a substantial portion of our revenue derives from a small number of key proprietary products; competition; the uncertainties related to the development of new products, including through acquisitions, and the related regulatory approval process; our dependence on third-party payors for the reimbursement of our products and the increasing focus on pricing and competition in our industry; unintended side effects caused by the clinical study or commercial use of our products; our use of hazardous materials in our manufacturing facilities; our ability to successfully execute acquisitions, partnerships, joint ventures, dispositions or other strategic acquisitions; our ability to protect our intellectual property rights and the substantial cost of litigation or other proceedings related to intellectual property rights; the risks related to product liability claims or product recalls; the significant number of laws and regulations that we are subject to, including due to the international nature of our business; macroeconomic trends and other global developments such as the COVID-19 pandemic; the terms of our debt instruments, changes in our credit ratings and our ability to service our indebtedness and other obligations as they come due; changes in applicable tax rate or tax rules, regulations or interpretations

and our ability to realize our deferred tax assets; volatility in our share price due to factors unrelated to our operating performance; and such other factors as set out in this Annual Report and Accounts.

Forward-looking statements contained in this Annual Report and Accounts apply only at the date of this Annual Report and Accounts. We undertake no obligation publicly to update or revise any forward- looking statement, whether as a result of new information, future developments or otherwise.

Millions of people around the world are addicted

to opioids - and it's tearing their lives apart. Many turn their backs on those suffering.

Indivior is not a typical pharmaceutical company. Our purpose is to help

change patients' lives by pioneering life-transforming treatment for substance use disorders, serious mental illnesses and overdose.

We are helping break the cycle of addiction with evidence-based

medical treatments.

These treatments can help people turn their lives around

and get on the path to long-term recovery.

Our purpose is underpinned by high standards of governance and

compliance. Our commitment to acting responsibly to ultimately create

value for all stakeholders is at the center of our decision-making.

Transforming

Lives

14

Read more about

our patient story

2023 Financial

Net revenue:

Net income:

Operating loss:

Results

$1,093m

$2m

($4m)

(2022: $901m)

(2022: ($53))

(2022: ($85m))

Net revenue

Adjusted

Adjusted

Year-end cash

from SUBLOCADE:

net income:

operating profit:

and investments:

$630m

$223m1

$269m1

$451m2

(2022: $408m)

(2022: $169m)

(2022: $212m)

(2022: $991m)

  1. Alternative financial measure. Please refer to the information on p. 56-59 following the caption "Alternative performance measures (adjusted results)" for a reconciliation to the corresponding IFRS measure.
  2. Includes $27m restricted for self-insurance.

1

IndiviorAnnual Report and Accounts 2023

A Global Crisis

Addiction is a Global

Human Crisis

Millions of people around the world are addicted

to opioids - and it's tearing their lives apart.

According to the United Nations, in 2021, approximately 60 million people used opioids for non-medical purposes1,

100 million people suffered from alcohol use disorder2, and 219 million people used cannabis1. In addition to an increase in people suffering from opioid use disorder (OUD), opioid overdose deaths are also on the rise due to the increased prevalence of fentanyl and other high potency synthetic opioids.

12 Month-ending Predicted Provisional Number of Drug Overdose Deaths by Drug or Drug Class in the U.S.3

48,126

29,689

5,862

2015

2016

2017

2018

2019

January

January

January

January

January

12-Month Ending Period

2

Alcohol

Opioids

Cannabis

Amphetamines

100m

60m

219m

& Cocaine

58m

people with

people used

users

users

alcohol use

opioids for non-

disorder

medical purposes

overdose

110,795

drug

Total

overdose

84,110

76,451

Opioid

overdose

opioid

Synthetic

of Deaths

1.

UNODC, World Drug Report 2023 (United Nations publication, 2023).

Number

2.

The Lancet Psychiatry, The global burden of disease attributable to alcohol and drug use in 195 countries

and territories, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016

(https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(18)30337-7/fulltext#%20).

3.

CDC National Center for Health Statistics (https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm).

2020

2021

2022

2023

January

January

January

January

Note: Predicted provisional counts represent estimates of the number of deaths adjusted for incomplete reporting.

3

Strategic Report

IndiviorAnnual Report and Accounts 2023

Social Stigma

Social Stigma Still Exists

Many people turn their backs on those suffering.

People suffering from addiction and serious mental illnesses are frequently subjected to stigma, and many remain under-diagnosed,under-treated and under-supported.

8.9 m

Misuse opioids in U.S.

(Total addressable market)

Strategic Report

IndiviorAnnual Report and Accounts 2023

296 million

Significant treatment gap exists in the U.S. today

6.1 m

OUD

diagnosed in

U.S.

people worldwide misused drugs, that's nearly

1 in every 17 people.

UNODC, World Drug Report 2023 (United Nations publication, 2023).

1.1 m

Patients treated with Medication-Assisted Treatment (MAT) in last 12 months

No one is immune from addiction. It can affect men and women of all ages, races, ethnic groups and educational levels. It can happen to anyone - a friend, a neighbor, a coworker, a spouse, a brother, a sister or parent.

No one sets out to become addicted.

Breaking the cycle of addiction with evidence-based medical treatments

Medication to treat opioid use disorder (MOUD) is a critical part of the solution to the global crisis.

OUD is a treatable chronic brain disease. While therapy and rehab are powerful tools in opioid use disorder and substance use disorder recovery, science shows that patients who use medication in addition to treatment experience a higher rate of recovery.

Raising awareness to overcome barriers

At Indivior, we not only work to expand evidence-based treatment options for people suffering from substance use disorder (SUD), serious mental illness and overdose but we also raise awareness among opinion leaders, policymakers, patient advocacy groups and the public about addiction as a chronic, relapsing disease that can be treated with medication.

Unfortunately, most people who could benefit from medication do not receive it. Overcoming the major barriers to access is critical to addressing the opioid crisis.

We intend to transform addiction from a global human crisis to a recognized and treated disease worldwide. The numbers are staggering. The need is clear. That is why we place the patient at the center of our decisions.

SAMHSA, Key Substance Use and Mental Health Indicators in the United States: Results from the 2022 National Survey on Drug Use and Health (https://www.samhsa.gov/data/sites/default/files/reports/rpt42731/2022-nsduh-nnr.pdf).

4

5

Addressing the Challenge

Indivior is Addressing the Challenge

Our company was founded to help combat the opioid crisis, one of the most urgent public health emergencies of our time.

Indivior is a global leader in addiction treatment and science

Net revenue by geography

U.S.

Net revenue by product

SUBLOCADE (SL)®

$1,093m

Rest of world

Rest of world

Sublingual film (U.S.)

PERSERIS®

16%

4%

13%

58%

25%

84%

As the pioneer in developing MOUD, Indivior has worked for

Today, we continue to pioneer innovative, life-transforming

over 25 years to reduce barriers to access, while advocating

treatments for people with substance use disorder

that OUD should be treated like other chronic diseases.

and serious mental illness. Our vision is that the millions

of people across the globe suffering from these diseases

have access to evidence-based treatment to change lives.

6

Our global presence

Canada

U.K.

EU & Middle East

36

165

82

people

people

people

USA

849

people

Employees

Australia

32

Canada

36

Finland

2

France

20

Germany

22

Ireland

6

Israel

5

Italy

18

Sweden

9

United Kingdom

165

United States

849

Total

1164

7

Australia

32

people

Strategic Report

IndiviorAnnual Report and Accounts 2023

Our Leading Pipeline

We are Creating a Pipeline to Treat Patients

At the heart of research and development (R&D) is an unwavering

commitment to support the patient journey to treatment and recovery.

Creating a pipeline for tomorrow

The development of drug addiction occurs in a chronological sequence spanning the acute reinforcing effects of the drug, the transition from drug use to abuse, and the end-stage of addiction that is characterized by loss of control over drug-seeking and drug-taking. The temporally sequenced stages of addiction are associated with adaptive changes in both functional and structural plasticity of brain synapses. Indivior's core guiding principle

  • focus on patient needs to drive decisions - incentivizes R&D to fully understand the neurobiological underpinnings of withdrawal symptoms, drug intake, craving, relapse and co-morbid psychiatric associations, and to advance treatment innovation by focusing on the importance of continuity of care and monitoring patient progress in the short, medium and long term.

Strategic Report

IndiviorAnnual Report and Accounts

Preclinical

Phase 1

Phase 2

Treatment of Opioid Use Disorder

Buprenorphine SL tablets

Treatment of Opioid Use Disorder

Buprenorphine and naloxone SL tablets

Treatment of Opioid Use Disorder

Buprenorphine and naloxone SL film

Treatment of Opioid Use Disorder

RBP-6000 buprenorphine extended-release injection for subcutaneous use

Treatment of Schizophrenia

RBP-7000 Risperidone XR injection for subcutaneous use

Treatment for Opioid Overdose Rescue

OPNT-003 opioid receptor antagonist nalmefene nasal spray

Treatment of Cannabis Use Disorder

AEF0117* cannabinoid-1 receptor synthetic signaling specific inhibitor

Treatment of Opioid Use Disorder

INDV-6001** is a sustained-release

LAI prodrug of buprenorphine

Treatment for Opioid Use Disorder

INDV-2000 selective orexin-1 receptor antagonist

Treatment for Alcohol Use Disorder

INDV-1000***gamma-aminobutyric acid subtype B (GABAB) positive allosteric modulator (PAM)

Treatment for Acute Cannabinoid Overdose

INDV-5004@ cannabinoid-1 receptor antagonist

Treatment for Alcohol Use Disorder

Discontinued

INDV-4002** opioid receptor antagonist

naltrexone nasal spray

  • Previously OPNT-004 (Drinabant).
  • Option to license agreement with Aelis Farma (Indivior has an exclusive option to license this technology).
  • Indivior has an exclusive global license agreement (except in China, Hong Kong, Taiwan and Macau) with Alar Pharmaceuticals, Inc. for this technology.

8

Phase 3

Regulatory

Commercial

Phase 4

Approval

Launch

  • Indivior has an exclusive license agreement with Alar Pharmaceuticals, Inc. for this technology.
  • Indivior has an exclusive license agreement with Addex Pharma S.A. for this technology.

The arrow placement in the column is not a direct reflection of its progress within the phase.

9

2023

Our Culture

We Act With a Culture

of Integrity

Our Global Integrity & Compliance Program

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Strategic Report

IndiviorAnnual Report and

We take building our culture of compliance seriously.

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Accounts 2023

Guiding Principles

We have a special responsibility to the patients we serve to conduct ourselves at a high level of integrity. As a business operating in a highly regulated environment, compliance and conducting our business with integrity are critical to our long-term success. Our commitment to strong governance is embedded within a culture focused on patient needs, patient safety and product quality.

Our people and culture - read more on page 24

Focus on patient needs to drive decisions

Seek the wisdom of the team

Believe that people's actions are well intended

Care enough to coach

See it, own it, make it happen

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Demonstrate honesty and integrity at all times

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"Our employees' dedication to our patients and Guiding Principles continue to inspire me. By living out our Guiding Principles in our day-to-day activities, we foster a culture that drives sustainable growth to create social value in the communities we serve."

Mark Crossley

Chief Executive Officer

10

Supported by our Guiding Principles, the Indivior Global

by the Integrity & Compliance (I&C) team who

Integrity & Compliance Program (IGICP) is based on U.S.,

support business and function owners through

global regulatory and industry code standards. IGICP

daily application and compliant execution.

is designed to guide our daily activities and behaviors

with systems, tools and ongoing learning through a cycle

of "Learn, Adjust, Prevent." The program is administered

Compliance and how we manage our business responsibly - read more on pages 40 to 42.

11

Chair's Statement

Focused on Long-termValue Creation

"As we enter our tenth year as a standalone company, we do so with good confidence, momentum and an unwavering focus on patients."

Graham Hetherington

Chair

On behalf of the Board I would like to thank Dan, Lorna and Tom for their dedication and service to the Group's stakeholders and for their commitment to ensuring a smooth transition in their important roles.

As we enter our tenth year as a standalone company, we do so with good confidence, momentum

Strategic Report

IndiviorAnnual

Graham Hetherington

Chair

My Board colleagues and I believe that 2023 was a year of significant accomplishments toward building a durable enterprise to create sustainable value for all Indivior stakeholders.

In short, we believe we substantially increased the Group's potential for strong earnings and cash flow generation, while simultaneously de-risking the enterprise. As we look forward, in partnership with the management team, our focus will be on delivering on the medium-term profitable growth profile we outlined at our December 2022 capital markets day event. Our focus will be to generate margin expansion and stronger operating cash flow through a combination of continued strong top-line growth and a leverageable cost base.

In November 2023, we added a new Non-Executive Director with the appointment of Dr. Keith Humphreys, a leader in the field of clinical psychology and substance use disorders. Also, as previously announced, having served nine years, Daniel J. Phelan, Senior Independent Director and Chair of the Remuneration Committee, and Lorna Parker, Non-Executive Director, retired from the Board. Dr. A. Thomas McLellan, who also had served for nine years, agreed to remain on the Board until his successor had been appointed and a period of transition had been completed. Following

and an unwavering focus on patients.

I look forward to reporting on our 2024 accomplishments.

Graham Hetherington

Chair

Report and Accounts 2023

We are, however, highly aware that 2023 presented challenges. Near-term concerns about ongoing litigation and payments related to the settlement of the antitrust multi-district litigation weighed heavily on the Group's share price. While these events were complex and challenging, resolution of these legacy issues reduced the Group's legal and financial exposure, allowing for removal of the material uncertainty about the Group's ability to continue to adopt the going concern basis of accounting.

We believe that proactively settling this legacy legal matter along with the strategic accomplishments we achieved during the year will

be recognized and rewarded over time. We were very pleased to see the partial recovery in the Indivior share price with the release on February 22, 2024, of our strong underlying full-year 2023 results and positive full-year 2024 guidance based on the expected continued strong progression of SUBLOCADE net revenue and the expected resultant margin expansion. Our confidence in the long-term value creation potential of the Group is evidenced in the third $100 million share repurchase program we initiated in November 2023.

Further notable 2023 milestones that will contribute to Indivior's future value include:

  • The successful consummation and integration of the Opiant Pharmaceuticals, Inc., business and subsequent approval and launch of Opiant's lead asset, OPVEE.
  • The addition of promising assets to the Group's addiction-focused pipeline. These included securing global rights to Alar Pharmaceuticals' portfolio of long-acting injectable formulations, principally ALA-1000, potentially the first three-monthlong-acting buprenorphine injectable for OUD, and taking full ownership of INDV-2000, potentially a non-opioid treatment for OUD based on selective orexin-1 science.
    Both ALA-1000 and INDV-2000 have the potential to be innovative new treatments for OUD that deliver on unmet patient needs.
  • The transformation of our supply chain with the acquisition of an aseptic manufacturing plant. The addition of this U.S.-based asset should ultimately help secure the long-term supply needs
    of SUBLOCADE and PERSERIS, as we continue to grow them toward their expected NR goals of >$1.5 billion and $200
    to $300 million, respectively.
  • Continued strong levels of investment behind the Group's commercialized products, including expanding SUBLOCADE's U.S. commercial reach and building an entirely new commercial team for OPVEE.
  • The successful listing of Indivior's shares on the Nasdaq Global Select Market and recent initiation of the process to potentially make the Nasdaq listing in the U.S. the Group's primary listing, if supported by shareholders.
  • Publication of the Group's second annual Sustainability Report covering 2022.

With our third $100m share repurchase program continuing (which commenced in November 2023), our near-term capital allocation priorities will be to maintain financial flexibility and prove the value of the capital deployment decisions referenced above. We do not expect material business development in 2024.

On October 1, 2023, we effected the Board's succession plans and also made changes to the structure and composition of the Board's committees. These changes reflect our active evaluation and optimization of Board expertise to support Indivior's strategy. They also reflect our continued focus on developing innovative treatments that meet patient needs, conducting our business with the highest integrity and meeting our commitment

to sustainability.

Dr. Humphreys' appointment in November 2023, Dr. McLellan retired as a Non-Executive Director at the end of February 2024.

Further, as part of our announced plans, Juliet Thompson took on the role of Senior Independent Director and Jo Le Couilliard assumed the Chair of the Remuneration Committee. Finally, as part of the amended relationship agreement with Scopia Capital Management, Jerome Lande's Board tenure was extended until December 31, 2024. Scopia remains one of Indivior's largest and longest-tenured shareholders.

As a result of these changes, the Board has successfully transitioned from 12 to 10 members as of March 1, 2024. More information on our Board members and the composition of the Board's Committees can be found on pages 78 to 79 of this report.

12

13

Patient Story

Rich's Story

Transforming the lives of others

Strategic Report

IndiviorAnnual Report

Like his father and grandfather, Rich was a firefighter who always answered the call for help. During 32 years as a firefighter and paramedic, including 12 years as a fire chief, he saved the lives of 15 people, rescued many more from fires, and delivered five babies into the world. Today, Rich is still helping people, but in a very different way. His personal journey through addiction and recovery inspires him to help transform the lives of others suffering from opioid use disorder.

Rich's journey began when he was prescribed opioid painkillers after knee replacement surgery. For months after being discharged from the hospital, he continued taking the painkillers. For a while, he was able to get them easily with phone calls. Eventually, however, Rich found

himself in a predicament: he was addicted to the painkillers but lacked any legal means of obtaining them. He resorted to theft and spent time in jail for stealing money to sustain his drug habit.

After being released, Rich began a treatment regimen, but often relapsed. He looks back at that period and realizes he was experiencing depression, which got worse

the harder he tried to fix things. Eventually, he was prescribed

a medication-assisted treatment that helped transform his life.

Just as he worked hard to be a fire chief, Rich is now working hard at an in-patient treatment center, where he helps others in their journey through opioid use disorder.

"My father and grandfather ingrained in me the importance of helping people," says Rich. "Many of our center's clients are in a similar situation as I was. I'm excited

to share my story with them.

I hope it will help make a difference in their own recovery."

"It allowed me to stay sober long enough to work on my mental and physical issues without getting sidetracked. Now, I only think about my future. Recovery is no longer a negative thing in my mind."

Rich

and Accounts 2023

14

15

Community Advocate Story

Steve's Story

Transforming lives by breaking down barriers between patients and law enforcement

Strategic Report

IndiviorAnnual Report

Steve understands the role of law enforcement officers is to serve and protect. He also believes these officers can play a critical role in helping people who have suffered an opioid overdose.

As the recovery support director with the Alliance of Coalitions for Healthy Communities (the Alliance) and a member of Oakland County, Michigan's, crisis response unit, Steve partners with law enforcement, mental health and addiction professionals and patient advocates to help people suffering from substance use disorders access treatment.

Steve is pioneering a transformative approach. Recognizing law enforcement's core mandate

of service and protection,

Steve advocates for their pivotal role in aiding those experiencing opioid overdose.

Steve has been with law enforcement officials when they've utilized rescue medications to reverse an overdose.

He has also followed up with patients to help them access the continued treatment they need.

"We all have a role and a place," Steve says about the insights he provides about SUD while training officers to respond to overdoses. "As someone who suffered from opioid use disorder, alcohol use disorder and stimulant use disorder, I can apply my first-hand experience to help reduce stigma around these often co-occurring mental illnesses as well as help confront common stigmas against law enforcement."

Steve delivers invaluable insights during officer training sessions, fostering understanding and empathy while combating prevailing stigmas associated with both SUD and law enforcement.

Using his extensive engagement with the recovery community, the Alliance and law enforcement agencies, Steve is instrumental in reducing barriers that hinder understanding and trust between individuals confronting SUD and co-occurring mental illnesses and the officers positioned to guide them toward recovery. By facilitating empathetic dialogues, this collaborative effort has proven effective in dispelling stigmas, ultimately leading to profound transformations in the lives of those impacted and their communities.

"Through in-depth conversations

filled with compassion, humanization and understanding, this partnership has been shattering stigma in both directions. Our mission is not solely about saving lives but also creating a catalyst for profound personal transformations that ripple through communities, touching the lives of loved ones, neighbors and employers alike."

Steve

and Accounts 2023

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Indivior plc published this content on 13 March 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 March 2024 14:37:19 UTC.