2016 Annual Report

Addressing patient needs - together

As the world leader in opioid
addiction treatment, our vision is for
all patients around the world to have
access to quality treatment for the
chronic relapsing condition and
co‑morbidities of addiction.

We focus on you.

Overview

Key performance highlights

Key pipeline highlights

Our strategic priorities

Building the resilience of our franchise

Progress in 2016

  • Maintained market leadership in the US with Suboxone® Film, which increased its average market share slightly to 61% (2015: 60%)
  • Maintained market leadership of the buprenorphine medication assisted treatment (BMAT) market in Europe, despite the availability of buprenorphine generic tablets
  • Started to build out our Medical Affairs team to engage with and educate key stakeholders

Focus going forward

  • Continue to develop opportunities arising from legislative and regulatory change, such as the Comprehensive Addiction and Recovery Act legislation and HHS final rule in the US
  • Increase US investment to help expand patient access to treatment
  • Expand capacity in Medical Affairs to enhance disease state education and scientific exchange related to the need for diagnosis and treatment of opioid use disorder
  • Continue to defend our intellectual property (IP) in relation to Suboxone® Film which is subject to challenge from multiple generic manufacturers

Developing our innovative pipeline

Progress in 2016

  • Reported top-line results of Phase 3 efficacy and safety trial showing RBP-6000 achieved both primary and secondary endpoints
  • Increased investment preparing for the launch of RBP-6000 on its approval
  • Progressed RBP-7000 through Phase 3 efficacy, safety and extension trials, and gained agreement on NDA submission strategy with the FDA
  • Completed a Phase 2a study for arbaclofen placarbil in the US, leading to reformulation
  • Filed for market authorization in France for Nalscue®, which was granted ATU (pre-licensed access) status and made available

Focus going forward

  • Prepare to launch RBP-6000 on its approval, by focusing on enhancing scientific exchange and education, addressing new mechanisms of reimbursement, and establishing new specialty pharmaceutical distribution architecture
  • Prepare to launch RBP-7000 on its approval, by investing in planning activities, while remaining open on how best to monetize the asset
  • Conduct additional clinical studies and advance new formulation development for arbaclofen placarbil

Expanding global pipeline

Progress in 2016

  • Completed clinical trials in China for our Suboxone® Tablet RB-CN-10-0013 and submitted an NDA to the Chinese FDA
  • Submitted sNDS to Health Canada for additional Suboxone® Tablet dosage strengths 12 mg/3 mg and 16 mg/4 mg
  • Consulted with agencies in Europe, Canada and Australia regarding RBP-6000 and developed plans for filing in these regions

Focus going forward

  • Continue to work with regulatory agencies globally to expand our RBP-6000 development program
  • Continue engagement with key European stakeholders to develop awareness of under-recognized populations dependent on prescription opioid painkillers who may need treatment

Developing the business

Progress in 2016

  • Continued to assess options for targeted M&A and product acquisitions
  • Reviewed all external assets in addiction, concluding that most compete with products we already have

Focus going forward

  • Continue to invest in organic growth
  • M&A on hold until resolution of investigative and antitrust matters and ANDA uncertainties
  • Maintain strong financial discipline, and only ever make external investments if they bring value to shareholders and leverage our core competencies
Download our strategy

The global epidemic

Our people, culture, expertise and insight, coupled with our innovative technology and stakeholder relationships, mean we are well placed to address patients’ needs around the world.

Europe and Middle East

1.3m High-risk opioid users (Europe only)
14.2m Alcohol dependant

United States

2.4m Opioid dependent
12.4m Alcohol dependent

Canada

0.2m Opioid dependent
(opioid painkillers only)
1.2m Alcohol dependent

South Africa

0.1m Opioid dependent
0.9m Alcohol dependent

China

7.3m Opioid dependent
27.0m Alcohol dependent

Australia

0.2m Opioid dependent
0.3m Alcohol dependent
“The good news is
that addiction
can be managed
successfully.” - Tom McLellan, Ph.D.
& Non-Executive Director at Indivior
View case study

Patient journey

Patients are individuals, and different patients may have different needs. Understanding these needs is critical to supporting patients along their journey to recovery. In fact, our Company name, Indivior, is iconic of the individual patient’s journey to reclaim life from the disease of addiction, and our endeavor to address patients’ unmet needs.

Cravings, stigma and instability can impact a patient’s chances of recovery, which is why we provide educational resources and continue to advance treatment innovations to support patients’ needs.

Stages of change

Pre-contemplation

Not currently considering change.
Not seeking behavior change or treatment for addiction.
May believe that they have their problem under control.

Contemplation

Assessing how they think and feel about themselves in the context of their addiction.

Preparation

Nearly ready to act, and are frequently making changes that will lead to concrete actions.

Action

Adhering to treatment and learning new behaviors; rewarding oneself or being rewarded for making positive changes.

Maintenance

Adjusting to change and practicing new skills and behaviors to help sustain this change over time.

* Adapted from Prochaska, et al. (1992)

What is addiction?

Addiction is a chronic, relapsing disease characterized by: the compulsion to seek and take a particular drug; the loss of control in limiting intake of the drug; a negative emotional state, such as anxiety or irritability, when access to the drug is withdrawn.

What makes it a disease?

Addiction is not a moral failure: it changes the brain. The disorder is believed to trigger progressive changes to molecular and cellular mechanisms in specific neural networks, causing structural and functional changes that can be seen on MRI scans.

How is addiction treated?

By aiming to reduce drug use by decreasing cravings and addressing any withdrawal symptoms and co-occurring disorders through pharmacological and behavioral therapy, as well as psychosocial support to eventually end drug-taking behavior.

What are treatment options for addiction?

Medication-assisted treatment – the use of medications in combination with counseling and behavioral therapies – is one approach to the treatment of substance disorders. There are two main types of medication-assisted treatment for opioid dependence: methadone and buprenorphine.

“Now that I am in recovery, I feel hopeful for the future.” - Matt, Patient
View case study

Our business model

We are a global specialty pharmaceutical company and the world leader in opioid addiction treatment. Every decision we make is informed by our Guiding Principles, and everything we do is intended for the benefit of patients.

Our Guiding Principles

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

Demonstrate honesty and integrity at all times

What makes us different

We rely on the following competencies to achieve our vision that all patients around the world will have access to quality treatment:

Patient focus

Our patient insights enable deeper understanding of the needs of patients and their journey to recovery.

Culture

Our strong culture is a differentiator and our Guiding Principles influence our decision-making along with how we conduct ourselves.

Proven management experience

Our ability to leverage proven strategic and executional skills in a highly complex and regulated market.

Intellectual property

Our intellectual property on R&D technology and processes delivers significant value.

Policy development

Our ability to develop and execute a coordinated strategy of stakeholder engagement to transform attitudes and treatment models for marginalized diseases.

What we do

We work in partnership with other addiction thought-leaders and stakeholders to:

  • Broaden awareness that addiction is a complex, chronic, relapsing disease, and patients deserve to be treated, not stigmatized or punished.
  • Expand access to quality care by educating healthcare providers, payors, governments, policy makers, stakeholders and patients about the disease and clinically-proven treatment methods.
  • Enhance scientific understanding of the disease and patients’ unmet needs to stimulate innovation and drive better patient outcomes.
  • Demonstrate the positive impacts of a changed addiction treatment paradigm, from improved quality of life for individuals and families to the positive social and economic impacts to society.

Our treatment and pipeline focus is:

  • Opioid use disorder
  • Alcohol use disorder
  • Overdose rescue
  • Central Nervous System (CNS) disorders/schizophrenia

The value we create

Through focusing on patients’ unmet needs Indivior delivers value to a broad range of stakeholders.

Patients

  • Expanding access to treatments
  • Improving patient outcomes

Investors

  • Delivering financial returns and investing for future long-term growth and growing the value of investment over time

People

  • Providing a rewarding place to work for motivated employees

Society

  • Shifting attitudes towards addiction
  • Reducing healthcare costs
“Because of the
support from my
doctor and psychiatrist,
I am able to function
again.” - Michelle, Patient
View case study

Research and Development

Our mission in R&D is to discover and develop innovative medications that help transform patients’ lives through world-class science and a culture of collaboration.

Our global pipeline

Research & Development of Pipeline of Products

Phase 1
Phase 2
Phase 3
Regulatory Filings
Expanding the range of treatment options for opioid use disorder RBP-6000:
buprenorphine monthly depot
Addressing unmet needs in the treatment of alcohol use disorder arbaclofen placarbil
Opening access to rescue medications RBP-8000:
cocaine esterase
Addressing unmet needs in central nervous system (CNS) disorders RBP-7000:
risperidone monthly depot
“...we're always looking to
innovate treatment options
to address patients' unmet
needs.” - Sue Learned, Senior Vice President
View case study