Many journeys,
one destination.

2017 Annual Report

Our Vision is that all patients
around the world have access to evidence-based treatment for the chronic conditions and co-occurring disorders of addiction.

We focus on you.

Overview

Performance highlights

Pipeline highlights

“I firmly believe we are the company – working in partnership with other experts – best positioned to tackle the growing global addiction crisis. Our vision, patient focus, guiding principles, and pursuit of innovation will continue to drive Indivior’s success in delivering value for shareholders and meeting the unmet needs of patients.” - Shaun Thaxter, CEO, Indivior

Our strategic priorities

Building the resilience of our franchise

Progress in 2017

  • Maintained SUBOXONE Film’s leading share position at an average of 57% (2016: 61%) in our  largest market, the US, despite competition from lower priced generic options
  • SUBOXONE Film’s resilience demonstrates the strength of Indivior’s brand and our  focus on patient needs
  • Treatment capacity expanded to a record number of physicians and other qualified treatment  providers in the US, ending the year at about 48,480 providers, a 25% increase over 2016

Developing our innovative pipeline

Progress in 2017

  • SUBLOCADE – FDA approved on November 30th the first and only once-monthly treatment for moderate to severe OUD; SUBLOCADE now available to patients nationwide in the US
  • RBP-7000 (monthly risperidone injection) – FDA accepted submission of the NDA and established a PDUFA date of July 28, 2018; Q4 2018 launch expected, if approved
  • Arbaclofen Placarbil – Phase 1 Bioavailability Clinical Study Protocol (INDV-AP-102) completed; planning to meet with FDA to share our plans and agree on next development stages
  • Addex Therapeutics Strategic Collabora

At a glance - the global burden of disease

Our patient-focused platform – people, culture, collaboration and evidence-based innovation – uniquely position us to help address patients’ unmet needs for the chronic conditions and co-occurring disorders of addiction.

United States

2.1m Opioid use disorder
15.1m Alcohol use disorder

Europe and Middle East

1.3m High risk Opioid users (Europe only)
14.2m Alcohol dependent

Canada

0.2m Opioid dependent (opioid painkillers only)
1.4m Alcohol dependent

South Africa

0.1m Opioid dependent
1.2m Alcohol dependent

China

7.3m Opioid dependent
27m Alcohol dependent

Australia

0.2m Opioid dependent
0.3m Alcohol dependent
“I had reached rock bottom, but through determination and humility I worked my way back up. Gradually,
with the help of the treatment program, I got
my life back on track.” - Nathan, Patient

Stakeholder engagement

In 2017, Indivior’s advocacy efforts focused on shaping an external environment to help meet the unmet needs of patients and to destigmatize the disease of addiction.

Our focus

In supporting leading global advocacy organizations, Indivior focused on:

  • Expanding access to evidence based treatment and information.
  • Promoting education, advocacy and engagement.
  • Advocating for access to substance use and mental health benefits for US patients.
  • Breaking the intergenerational cycles of addiction.
  • Accelerating innovation through science, education and leadership conversations.
  • Awareness-building initiatives to help drive solutions. We are pleased to highlight the work of several of the organizations working tirelessly to advance change for patients and families suffering from addiction.

We are proud to support their efforts. Read their stories below.

Addiction Policy Forum, US

In the US, Indivior supports the Addiction Policy Forum (APF), a national organization working to elevate awareness around addiction and improve national policy through prevention, treatment, recovery and criminal justice reform.

During 2017, Indivior provided financial support for APF’s Emergency Medicine Initiative, an area of strategic focus for the organization. Through this initiative, APF is developing open-source materials to educate emergency responders to help ensure that non-fatal overdoses do not become fatal through reoccurrence, and to develop treatment protocols to help meet that goal.

“These post-overdose protocols are so important,” says Jessica Hulsey Nickel, founder and President & CEO, APF. “That’s where this support is so valuable – it helps to generate resources that simply didn’t exist before; resources designed to identify and help the most at risk families and individuals.” Jessica, whose parents died as a result of long-term opioid use disorder, has been advocating for a better response to addiction since she was 15 years old.

Indivior also provides financial support for APF’s CARA Family Day, named after the landmark Comprehensive Addiction and Recovery Act (CARA). Passed in the US in 2016, this legislation has advanced evidence-based prevention, treatment and recovery services for substance use disorders. APF’s annual event brings together families directly affected by addiction from all over the US to advocate on behalf of addiction resources and to raise awareness to help end the stigma surrounding this disease.

Parity at 10 Compliance Campaign, US

Indivior supports the Parity at 10 Compliance Campaign, a new partnership of leading national organizations working for effective enforcement of the Parity Act in ten US states over the next three years. One of the major recommendations outlined in the final report of the US President’s Commission on Combating Drug Addiction and the Opioid Crisis is the need for greater enforcement of the Federal Parity Act. Next year will mark the 10th anniversary of the landmark legislation, which mandates that health insurance plans’ standards for substance use and mental health benefits be comparable to, and be no more restrictive than, the standards for other medical/surgical benefits. Parity at 10 has launched in five states – Illinois, Maryland, New Jersey, New York and Ohio. The campaign’s work in each state includes researching the current treatment and policy landscape, conducting extensive public and provider education about the Parity Act, and, in partnership with local stakeholders and advocates, working with legislators and regulatory bodies to develop more effective compliance and enforcement frameworks.

Scriptwise, Australia

ScriptWise is a national non-profit organization, based in Australia, dedicated to reducing prescription medication misuse and overdose fatalities. In 2017, Indivior provided financial support for a range of activities including:

  • ScriptWise’s efforts to raise awareness of the importance of a Real Time Prescription Monitoring system for Australian States and Territories, and to provide information about over-the-counter codeine rescheduling in Australia.
  • A stakeholder treatment advocacy and awareness initiative which involved facilitating the start of Working Groups in Victoria and WA.
  • International Overdose Awareness Day activities.

Shatterproof, US

In support of Shatterproof, a nonprofit organization with a mission to end the devastation that addiction causes families, Indivior sponsored 5k walk/run events in Washington, D.C., Boston and Atlanta. The Shatterproof ‘Rise Up Against Addiction’ 5k walk/ run events brought together people affected by addiction and united in their passion to end the stigma of addiction by honoring loved ones lost to the disease and celebrating the hope of recovery. At the Washington, D.C. event, Indivior employees, family members and friends were among 800 people who participated to raise more than $300,000 to help communities advocate for evidence-based solutions and policy change. Dr. Ponni Subbiah, Chief Medical Officer, Indivior, highlighted Indivior’s commitment to patients in remarks at the opening program in Washington, D.C.

Harm Reduction Australia, New South Wales

In 2017, Indivior provided support to Harm Reduction Australia, a national organization for individuals committed to reducing the health, social and economic harms potentially associated with drug use. To encourage a thorough rethink of existing policies and support the much-needed reform of the Opioid Treatment Program (OTP) system, Indivior provided funds to Harm Reduction Australia to deliver a series of information and discussion forums with OTP stakeholders throughout late 2017.

The Hill, Washington D.C.

To help accelerate innovative solutions to the opioid crisis, in 2017 Indivior sponsored a leadership conversation in Washington, D.C. with The Hill newspaper. ‘America’s Opioid Epidemic, the Search for Solutions’ featured US federal and state government policy-makers, patient advocates, medical societies and healthcare advocates in thoughtful discussion about solutions to combat the opioid crisis. Closing the event, Indivior CEO Shaun Thaxter said: “We are facing a tremendous crisis of people suffering from chronic addiction and we must continue to increase access to care, invest in psychosocial support infrastructure and offer evidencebased treatment choices.”

DrugFAM, UK

DrugFAM is a UK-based global organization dedicated to providing safe, caring and professional support to families, friends and partners who are struggling to cope with a loved one’s addiction.

Indivior has supported DrugFAM for several years in its efforts to give families the strength to break free from the cycle of addiction and rebuild their lives. In the words of DrugFAM founder Elizabeth Burton- Phillips, the two organizations “are united about the need to destigmatize addiction and support those whose lives have been derailed by drug or alcohol misuse.”

Indivior’s support will help with the development of workshop materials to accompany a DrugFAM play adapted from Elizabeth Burton- Phillips’s book, Mum Can You Lend Me Twenty Quid? To date, the play, which depicts the effects of addiction on family life, has been performed 125 times in schools and communities, and the new workshop materials will provide additional tools and potential for education and engagement.

USA Today National Opioid Addiction Awareness

Recognizing that one of the greatest barriers to the patient journey to treatment and recovery is the stigma, prejudice and misconceptions around addiction and treatment, Indivior was a sponsor of the national Opioid Addiction Awareness Campaign feature in USA Today, in 6 major cities across the United States. By helping provide a platform for voices of the Addiction Policy Forum, Shatterproof and Faces and Voices of Recovery (FAVOR), Indivior helped give voice to how imperative ‘breaking down the barriers of stigma’ is to empowering treatment access for patients and removing the barriers of guilt and shame.

The Moyer Foundation, US

Founded in 2000 by American baseball player Jamie Moyer and child advocate Karen Phelps Moyer, The Moyer Foundation supports thousands of children and families each year with free-of-charge programs and services.

Indivior provides ongoing financial support to Camp Mariposa, The Moyer Foundation’s addiction prevention and mentoring program. Camp Mariposa serves youth impacted by the substance use disorder of family members, with the aim of breaking the intergenerational cycle of addiction.

Indivior’s three-year grant (beginning September 2016) supports the strengthening, growth and expansion of the Foundation’s prevention resources, sites and services. The newest Camp Mariposa location, serving Princeton, West Virginia, US, was launched in June 2017, with two additional locations opening in 2018. Indivior’s support also enabled infrastructure improvements for mentoring and addiction prevention, and partnership forming to help tackle stigma.

Community Anti-Drug Coalitions of America (CADCA)

For over five years, Indivior has provided educational grant support to the Community Anti-Drug Coalitions of America (CADCA) whose mission is to strengthen the capacity of communities to create and maintain safe, healthy and drug-free communities globally.

In 2017, CADCA implemented programs in those communities in greatest need of access to evidence-based care for opioid use disorder to help reduce the stigma associated with the disease of addiction, educate communities on medication-assisted treatment options and increase the number of health-care providers waivered to treat opioid use disorder.

Helping to reduce OUD mortality in France

In France, Indivior supported a partnership across several clinical and medico-social associations in support of the early access program for NALSCUE nasal spray for the emergency treatment of characterized or suspected opioid overdose.

During 2017, over 400 centers (addiction centers, hospitals, prisons and harm reduction centers), and 800 doctors, 200 pharmacists and hundreds of nurses, social workers and educators received training on overdose symptoms, risks, mortality and the use and benefits of NALSCUE.

Indivior also supported the patient advocacy group ASUD (Auto- Support des Usagers de Drogues) development of public information materials on harm reduction and treatment approaches.

“For more than 20 years Indivior has worked together with policymakers, medical societies, patient advocacy groups, healthcare providers, payers and other stakeholders to educate on the disease of addiction and advocate for patient access to evidence-based treatment.” - Shaun Thaxter, CEO, Indivior

Our Business model

Our Purpose

is to pioneer life-transforming treatment.

Our Vision

is that all patients around the world have access to evidence-based treatment for the chronic conditions and co-occurring disorders of addiction.

Our Mission

is to be the global leader who is a pioneer is developing innovative prescription treatments for addicted patients.

Indivior’s assets

Highly skilled and knowledgeable people

Indivior possesses an exceptionally able and experienced workforce that is committed to the improvement of patient lives and achieving long-term success.

Culture

Based on a clearly-defined set of principles and behaviors, Indivior’s culture is a key competitive advantage enabling Indivior to create not only a business that will prosper and grow, but an organization that will create lasting social value.

Stakeholder relationships

Indivior has strong and enduring relationships with its key stakeholders, including policy-makers, regulatory agencies, healthcare professionals, patient advocacy organizations and the investment community. These relationships provide Indivior with critical insights to develop and improve upon its patient-focused business approach.

Intellectual property

Indivior has a unique portfolio of licenses and patents which enable it to manufacture and market its treatments.

Capital base

Indivior’s cash generative business activities, combined with the Group’s access to the international capital markets, provide a stable base of liquidity that supports the Group’s principle day-to-day activities while providing it further resources for reinvestment in potential new treatments targeting addiction and its co-occurring disorders and for extending its overall competitive position.

What Indivior does

Manufacturing

Indivior discovered buprenorphine in Hull, UK, and developed it as a treatment for opioid dependence. Indivior continues to manufacture this key active ingredient for its opioid addiction treatments at its Fine Chemical Plant in Hull, UK. Indivior has continuously manufactured buprenorphine at this facility for over 50 years and believes it produces the highest quality buprenorphine in the world.

Responsible sales and marketing

Indivior is committed to conducting all of its sales and marketing activities responsibly and in compliance with the relevant regulations and guidelines. Although the Group’s corporate compliance department partners with the business to oversee certain activities and provide guidance, there is a clear understanding among the sales and marketing teams that they each share responsibility for compliance.

Conducting advocacy and raising awareness of the opioid addiction crisis

A key aspect of Indivior’s activities is raising awareness of the opioid addiction crisis in all the markets it serves through regular stakeholder dialogue and patient advocacy activities. These activities have contributed to expanded treatment access in the Group’s largest market, the US, over the last five years to record levels today.

Research and development

Indivior conducts world leading and innovative research and clinical development activities for the treatment of addiction and other co-occurring disorders. These efforts are led by staff in Fort Collins (Colorado, US), Richmond (Virginia, US), and Hull and Slough (UK).

Indivior’s investment case

Growing global marketplace for the Group’s existing product portfolio

The global addiction crisis has provided an opportunity for the Group to significantly expand the market for buprenorphine medication-assisted treatments, acknowledged as an evidence-based treatment for opioid use disorder, to help patients in their treatment journey.

Unique focus on and understanding of patient needs

Indivior is committed to addressing the global addiction crisis by expanding the availability of its patient-focused treatments, including increasing treatment access, while also leveraging its unrivaled knowledge in addiction science to develop novel treatments.

Innovative R&D pipeline

Indivior has consistently built on its leadership position in the treatment of opioid use disorder globally to develop new patient-focused treatments that in turn have enabled the Group to invest in its R&D pipeline. This skill set also has enabled the Group to consider expanding the scope of the treatments it provides to help address co-occurring disorders of addiction.

Strong profitability and cash flow

Indivior is highly profitable and cash generative, providing the resources required to fund day-to-day operations and reinvest in future growth opportunities, including new geographies and developing new treatment options for addiction and its co-occurrences.

Talented and experienced management team

Indivior possesses a talented, committed and experienced management team widely recognized by the industry as leading in the development of patient-focused treatments for addiction.

“I’m able to
use my experience
to help others. ” - Miguel, Patient

Research and Development

The science behind SUBLOCADE™

SUBLOCADE™ (buprenorphine extended-release) is the first and only therapy that, at steady state, delivers buprenorphine at a sustained rate of at least 2 ng/mL over a one-month period.

A unique delivery system

SUBLOCADE™ (buprenorphine extended-release) uses the ATRIGEL® delivery system, which consists of a polymeric solution of a biodegradable poly-(DL-lactide-co-glycolide) co-polymer dissolved in N-methyl pyrrolidone (NMP), a water-miscible biocompatible solvent. After subcutaneous injection, NMP interacts with body fluids that replace the NMP as it diffuses out of the polymer matrix, triggering polymerization. This traps the buprenorphine inside and forms a solid deposit in place. The depot releases buprenorphine over a one-month period by diffusion as the polymer biodegrades.

SUBLOCADE™ Lifecycle Evidence Generation & Optimization (LEGO)

During 2017, various studies were planned and designed and we will continue to generate and optimize evidence to support SUBLOCADE’s efficacy and strengthen Indivior’s leadership in the treatment of OUD. These included:

  • Emergency Room Study – to assess the efficacy and safety of initiating SUBLOCADE in ER settings to potentially prevent repeat overdose events in OUD patients.
  • VAS Craving Project – to explore how craving could be used as potential clinical endpoint in clinical trials in OUD patients.
  • Buprenorphine Abuse, Misuse, Diversion (AMD) Epidemiology – to investigate the root causes of  abuse and misuse in diverted buprenorphine.
ATRIGEL Delivery System

SUBLOCADE™ sustained-release formulation of buprenorphine. SUBLOCADE™ uses the ATRIGEL delivery system, a solution consisting of a biodegradable poly-(DL-lactide-co-glycolide) co-polymer dissolved in N-methyl pyrrolidone (NMP), a water-miscible biocompatible solvent. After subcutaneous injection, NMP interacts with body fluids that replace the NMP in the matrix, triggering polymerization. Buprenorphine trapped inside the polymer formed in situ is gradually released over a one-month period as the polymer biodegrades

How SUBLOCADE™ works

SUBLOCADE™ (300mg) administration leads to buprenorphine plasma concentrations of 2-3 ng/mL, mu-opioid brain receptor occupancy of ≥70% producing significant reductions in drug-liking. This graph is for illustrative purposes only.

The outcome: Abstinence rate

The primary efficacy endpoint (% abstinence from Week 5 through Week 24) was statistically significantly superior (P<0.0001) for both the 300 mg/100 mg and 300 mg/300 mg groups compared with the placebo group, with mean percentages as shown in the figure above.

Innovation through the decades

Innovation through the decades: Indivior’s R&D timeline

Indivior has a long history of supporting the addiction treatment community. It has been involved in manufacturing and supplying buprenorphine for OUD patients for decades.

Developing innovative treatments for OUD for decades

Strategic driver: Infrastructure

State of the art research and development centers

During the year, we completed our new R&D Center of Excellence in Hull (UK) (54,000 sq ft) and the extension of our R&D facilities in Fort Collins (CO, USA) (18,500 sq ft).

The new Hull facility is a $30 million R&D center dedicated to pioneering novel treatments for patients struggling with SUDs. The new center, which will house over 50 employees, is equipped with cutting-edge technologies, including a 400MHz Nuclear Magnetic Resonance spectrometer, and is constructed to environmental and energy-saving standards, including the installation of a 25kW solar panel farm to increase use of renewable energy.

As Indivior’s largest capital investment in R&D, it is hoped the new center will enable us to leverage science and research to help understand the neurobiological underpinnings of SUDs and advance the SUD treatment paradigm.

In the US, our $11 million investment in Fort Collins has increased the site’s footprint from 23,000 sq ft to 42,000 sq ft. It establishes Fort Collins as a leader in parenteral product development from a chemistry, manufacturing and controls (CMC) perspective.

Altogether, the new UK and US facilities will allow us to significantly expand our capabilities through pilot plant storage, formulation
laboratories, analytical laboratories, chemistry laboratories, stability chambers, office spaces, and support spaces. Not only will these facilities help us remain at the cutting edge of innovation and discovery, they will help keep our employees safe, and support our independence as an organization.

Pipeline milestones

Significant pipeline milestones for the year include:

 

“Indivior’s R&D program is dedicated to the development of innovative therapeutics that move the international community one step closer to new treatment options that help patients with substance use disorders (SUDs) worldwide improve their quality of life and well-being” - Christian Heidbreder, Chief Scientific Officer