2015 Annual Report

Shaun Thaxter

Our vision at Indivior is that all patients around the world will have unrestricted access to high-quality treatment services for the chronic, relapsing condition and co-morbidites of addiction.

Shaun Thaxter, Chief Executive Officer

Who we are

Indivior is a global specialty pharmaceutical company and the world leader in addiction treatment.

Our purpose

Our purpose is to pioneer life-transforming treatments.

Our vision

All patients around the world will have unrestricted access to high-quality treatment services for the chronic, relapsing condition and co-morbidities of addiction.

Our mission

Be the global leader who is a pioneer in developing innovative prescription treatments for addicted patients.

Our growth strategy is to:

  • Build the resilience of our franchise by continuing to expand patient access to treatment and maintain a leadership position.
  • Develop our innovative pipeline to help improve patient outcomes.
  • Expand global treatment by capitalizing on international growth opportunities.
  • Develop the business by creating growth through targeted and disciplined business development and acquisitions.

Our treatment and pipeline focus is:

  • Opioid use disorder
  • Alcohol use disorder
  • Overdose rescue
  • Co-morbidities of addiction / schizophrenia

Our Guiding Principles are:

  • Focus on patient needs to drive decisions
  • Care enough to coach
  • Believe that people's actions are well intended
  • See it, own it, make it happen
  • Seek the wisdom of the team
  • Demonstrate honesty and integrity at all times

Our products

Indivior-04-Product-family

Indivior’s core products, which are currently available in over 40 countries, are Suboxone® Film (buprenorphine and naloxone), Suboxone® Tablet (buprenorphine and naloxone), and Subutex® Tablet (buprenorphine), all of which are approved to treat opioid dependence.

Indivior’s main geographic market (based on the country where the sale originates) is the US, which accounted for 80% of net revenues in 2015 (2014: 77%) and where Suboxone® Film is the buprenorphine market leader. Rest of world, Suboxone® therapies and Subutex® Tablet are market leaders.

Our global presence

Performance summary

Indivior had a very encouraging first year as a public company. Suboxone® Film demonstrated the resilience of our core business in the US, and our pipeline of potentially transformational treatments for addiction made progress. Above all, we helped more patients transform their lives from addiction.

We made significant strategic progress, and our belief in the growing medium-term opportunity for Indivior continues to be strong.

Financial

Market share

Pipeline

US: Competition is intensifying, but Suboxone Film remains resilient

Europe: Clear market leadership, but pressure from austerity measures

Global view of addiction*

The costs to society of addiction are frightening, not just in terms of consequences to health, but in crime, social dislocation, unemployment and, unfortunately, death. The global disease burden due to drug use is estimated at 3.6 million years of life lost due to premature death in 2010. Worldwide, 3.3 million deaths are attributed to alcohol.

Too many lives are lost, unnecessarily – more can be done.

We are relentless in our pursuit to expand access to high-quality treatment services for addiction for patients

Transforming Addiction

At Indivior, we have always understood that success in treating addiction requires more than just the right products. Our fundamental task is shifting attitudes around addiction and expanding unrestricted access to high-quality treatment services. We have built a sustainable growth business in addiction by placing patients firmly at the heart of our business, at the center of our decision-making, and always at the front of our minds.

We intend to transform addiction from a global human crisis to a recognized and highly treated disease.

Cheryl
Shaun Thaxter
Duncan
Tim Baxter
Dr. Mark Menestrina
Jolene Head
Dr. Ken Lee Canada
Michelle
Dr. Med. Patric Bialas Germany
Dr. Christian Heidbreder
Dr. Walter Ling US
Richard Simkin

Cheryl Patient,
US

I do whatever I can to raise awareness of addiction. I want people who find themselves bound in the vicious cycle of opioid addiction to realize that life is waiting for them, and with the right treatment, the journey back isn’t as far away as one may think.

Read more about Cheryl’s journey and transformation on page 1

Shaun Thaxter

Shaun is the Chief Executive Officer at Indivior.

Our vision at Indivior is that all patients around the world will have unrestricted access to high-quality treatment services for the chronic, relapsing condition and co-morbidities of addiction.

Read more about the CEO’s vision for Indivior on page 6

Duncan Patient,
UK

You don’t wake up one day and say, “I’m going to be a heroin addict”. I went into drugs quite slowly and gradually, and I came out of drug addiction quite slowly and gradually.

Read more about Duncan’s journey and crusade on page 26

Tim Baxter

Tim is the Chief Medical Officer at Indivior.

Read more about the disease of addiction on page 12

Dr. Mark Menestrina

Mark is a Medical Science Treatment Advisor at Indivior, US.

I’m a trained Family Practitioner. My advantage having treated addiction patients, and having been a patient myself, is that I relate to the doctors when I interact with them on this complicated disease.

Read more about Mark’s role and experience with addiction on page 23

Jolene Head

Jolene is a Clinical Liaison at Indivior, Canada.

I spend the majority of my time working to expand the network of physicians treating addiction and connecting the treatment community to help make the system better for patients.

Read more about Jolene’s role and efforts to expand access to treatment on page 24

Dr. Ken Lee

Indivior has helped me expand the reach of addiction services here in London, and I think across Canada too. It’s a good thing Indivior is doing, helping doctors connect, because it’s helping more patients.

Read more about Dr. Lee’s experience treating patients on page 24

Michelle Patient,
Canada

There is absolutely no certain ‘face of addiction’. To me, being addicted meant you were on the street buying drugs on the corner. Never did I think that you could become addicted taking a drug prescribed by a doctor.

Read more about Michelle’s journey and victory on page 24

Dr. Med. Patric Bialas

All pain doctors have a patient we know is addicted to opioids. Now, we are starting to get some tools from Indivior to help focus on these patients.

Read more about Dr. Bialas’ views on treating opioid addiction on page 27

Dr. Christian Heidbreder

Christian is the Chief Scientific Officer at Indivior.

Read more about Indivior’s R&D focus and pipeline of potentially transformational treatments on page 28

Dr. Walter Ling

The challenge for patients around the world is that even when addiction is recognized as a disease, they are often still treated like sinners. This is a huge barrier, and Indivior is trying to take it down.

Read more about Dr. Ling’s pioneering work with buprenorphine on page 22

Richard Simkin

Richard is the Chief Commercial Officer at Indivior.

Read more about Indivior’s 2015 performance on page 34

Advocating, engaging and connecting for patients

Opioid painkiller addiction is a growing concern in Europe and Australia where heroin had previously been the primary focus. Indivior is helping to educate the public about opioid painkiller addiction.

International Overdose Awareness Day

In Australia, Indivior actively partnered with Scriptwise, a non-profit organization that aims to raise awareness on prescription medication misuse and overdose, to support International Overdose Awareness Day.

Opioid Painkiller Addiction Awareness Day (OPAAD)

On September 22, 2015, OPAAD was established by Indivior as the first annual public health education day on opioid dependence in the UK. OPAAD generated news stories, social media, and a national radio conversation, reaching 46.8 million listeners.

In the US, nearly 6 million unique visitors accessed our online opioid dependence websites:

Turn-to-Help.com educates on the disease of opioid addiction and how treatment can help, as well as provides a search tool for patients to locate a waivered physician in their area.

Suboxone.com is aimed at supporting patients at each stage of their journey, including tools to find a trained and waivered physician and savings cards for medication.

Innovations for patients and physicians

We continue to innovate ways to help enhance the patient treatment experience and outcomes, including tools for patients and physicians. In 2015, we piloted a Suboxone® Film app on the Mobile Health Library platform with features to assist patients with their treatment plan and to aid patient-physician communications.

  • In pilot, the Suboxone® Film app generated an unprecedented patient and physician response rate in three months that has taken similar apps in other disease conditions 10-14 months to achieve.
  • In 2016, the Suboxone® Film app will be expanded with additional enhancements.

Access to medicine

In 2015, Indivior provided Suboxone® Film product valued at $16m through its Patient Assistance Program in the US. Since 2010, the program has provided access to medicine for more than 30,000 financially needy patients, an average of 5,000 per year.

Reclaiming lives

We intend to transform addiction and that means also breaking the cycle of addiction that impacts families and communities. This year, Indivior became a corporate sponsor of Camp Mariposa, a program of the Moyer Foundation.

Pioneering products & pipeline

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. In 2015, we increased our investment in R&D by 29% to $148m (vs. 2014: $115m), and we achieved multiple milestones to support our current commercial buprenorphine products and across our addiction treatment pipeline.

Our focus is patients’ unmet needs, including relapse, diversion and abuse. We aim to develop products that patients and physicians prefer.

Suboxone® theraples: Global progress

United States

With FDA approval of buccal administration in September 2015, patients in the US now have an option to place their daily dose of Suboxone® Film against the cheek, or under the tongue.

Europe

The EU approved Suboxone® Tablet 16mg/4mg strength tablets in November 2015, providing patients and physicians with expanded dosing options. However, our application for Suboxone® Film formulation has been delayed, as the prototype formulation for EU has not met its specified bio-equivalency to EU Suboxone® Tablet formulation.

China

Suboxone® Tablet clinical trials are progressing very well. In December 2015, a pivotal Phase 3 efficacy trial and Multiple Dose study were completed, paving the way for preparation of an NDA to be submitted to China FDA in 2016. In addition, the Clinical Trial Application (CTA) to initiate clinical efficacy and safety trials for Suboxone® Film was approved by the Chinese Center for Drug Evaluation.

An innovative pipeline designed to improve patient outcomes

Products in pipeline: Opioid, Alcohol, Schizophrenia

Opioid use disorder (OUD)

Buprenorphine Monthly Depot
With Buprenorphine Monthly Depot, patients do not need to make a daily decision to take their medication. This has the potential to cut ‘decision days’ to just 12 a year.
  • Treatment need: Reduce risk of relapse, misuse and diversion
  • For patients: Monthly depot can reduce decision days from 365 a year to 12
  • For physicians: Aims to improve compliance and reduce potential for diversion
  • For payors: Potential decrease in overall healthcare costs
  • Technology: Uses existing Atrigel platform
  • Stage: Phase 2 data published. Phase 3 efficacy trial – all patients enrolled;  in progress
  • Estimated approval: 2017

Atrigel®

is an FDA-approved drug delivery platform used for the treatment of prostate cancer, under the brand name ELIGARD®.

Using Atrigel, the medication is injected as a liquid, subcutaneously in the abdomen, where it solidifies, releasing the drug slowly (typically over a month) before biodegrading.

ELIGARD is a trademark of the TOLMAR group

Alcohol use disorder (AUD)

Arbaclofen Placarbil
With Arbaclofen Placarbil, patients do not have to abstain from drinking or detoxify first. This could transform the treatment of alcohol use disorders – just as buprenorphine has done with opioid dependency.
  • Treatment need: Reduced harmful drinking days
  • Significant undertreated population: 124.2m worldwide
  • No mainstream treatment currently available
  • Transforms treatment: Does not require detoxification before treatment
  • Leverages ‘the known’: Existing compound completed Phase 3 safety trials for different therapeutic indication
  • Stage: Initiated Phase 2 trial
  • Estimated approval: 2020

Alcohol use disorder

Recently, the US FDA released draft industry guidance to assist in the clinical development of AUD medications, reinforcing growing interest in reducing harmful drinking among a much larger population, who are drinking more than is good for their health, but who would not necessarily be classified as alcoholics.

Co-morbidities of addiction

Risperidone Monthly Depot in Atrigel
Research tells us physicians and psychiatrists prefer a monthly treatment for schizophrenia. This will be the only monthly depot of risperidone, the most widely prescribed compound for the treatment of schizophrenia.
  • Treatment need: Improved adherence
  • Existing risperidone is only a two-week depot
  • Leverages ‘the known’: Existing compound that uses Atrigel platform, already on market (prostate cancer)
  • Stage: Phase 3 long-term safety study ongoing and on track. Compelling preliminary data for Phase 3 efficacy trial published May 2015
  • Estimated approval: 2017

Risperidone

is an efficacious and trusted molecule with 20+ years of data and physician experience supporting its efficacy. It is the most commonly used antipsychotic to treat schizophrenia. The monthly depot is targeted to be the first risperidone product to enable once-a-month dosing, not requiring on-top dosing with oral tablets to supplement efficiency.

Operational Highlights

Our first year as an independent public company has been a rewarding experience. We have delivered strongly on our key objectives, and we have also made strategic operational progress in 2015.

The resilience of Indivior is ultimately down to the quality, passion and commitment of our people.

Increased employees, staffing corporate operations needed as a stand-alone company and bolstering R&D and commercial capabilities.

(885 employees vs 2014: 728)

The implementation of our annual global employee survey to assess our culture and identify opportunities for improvement.

Our assumption of operating responsibility for the Fine Chemical Plant (FCP) in Hull, UK, where all our buprenorphine is made, following the demerger.

The implementation of our Enterprise Resource Planning (ERP) project with the introduction of SAP – the first countries are now live and running smoothly.

The implementation of our name change to Indivior across virtually all our operating companies.

2016 Priorities

We have welcomed many new Shareholders to the Company in 2015, and we are committed to ensuring your trust is well placed in us. There is still much work to do, and we are inspired by the progress being made around the world by so many who are deeply invested in changing the treatment paradigm for patients.

Indivior-15-2016-priorities

In 2016, Indivior’s priorities are to:

  • Continue to expand access to treatment for the chronic, relapsing disease of addiction in the US and globally;
  • Build on the resilience of our existing franchise with Suboxone® Film in the US;
  • Continue relentless progress in developing our pipeline of potentially transformational treatments for addiction;
  • Seek appropriate diversification of the business into strategically interesting new sources of revenue and cash flow; and
  • Strengthen the Company’s financial position.