2015 Annual Report
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
Our purpose is to pioneer life-transforming treatments.
All patients around the world will have unrestricted access to high-quality treatment services for the chronic, relapsing condition and co-morbidities of addiction.
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
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
We made significant strategic progress, and our belief in the growing medium-term opportunity for Indivior continues to be strong.
US: Competition is intensifying, but Suboxone Film remains resilient
Europe: Clear market leadership, but pressure from austerity measures
Global view of addiction*
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
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.
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.
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 focus is patients’ unmet needs, including relapse, diversion and abuse. We aim to develop products that patients and physicians prefer.
Suboxone® theraples: Global progress
An innovative pipeline designed to improve patient outcomes
Products in pipeline: Opioid, Alcohol, Schizophrenia
Opioid use disorder (OUD)
Buprenorphine Monthly Depot
- 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
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)
- 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
- 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
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.
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.
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.
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.