Annual Report 2018 Annual Report
Patient needs inspire us…
Annual Report 2018 …and our vision that all patients around the world have access to evidence-based treatment for the chronic conditions and co-occurring disorders of addiction.
Patient needs inspire us…
Our people, culture, expertise and insight, coupled with our innovative technology and stakeholder relationships, uniquely position us to help address patients’ unmet needs around the world.
2018 Highlights $1,005m $292m $275m Net revenue Operating profit Net income (-8% vs. 2017: $1,093m) (+51% vs. 2017: $193m) (2017: $58m) 53% $332m $272m US average market share Adjusted Operating Profit* Adjusted Net Income* (vs. 2017: 57%) (-18% vs. 2017: $403m) (+1% vs. 2017: $270m) 894,256 38c 37c US unique patients Earnings per share Adjusted earnings per share* received SUBOXONE® Film (2017: 8c) (nil vs. 2017: 37c) (vs. 2017: 874,481) * excluding exceptional items (further details on page 25)
Key pipeline highlights Contents
Strategic report Governance $91m* 4 Chair’s statement 36 Chair’s governance statement R&D investment 6 Patient journeys 38 Board of Directors (+2% vs. 2017: $89m) * includes exceptional costs of $24m 10 Business Model 40 Executive Committee 12 Chief Executive Officer’s 42 Corporate Governance Report statement 62 Directors’ Remuneration Report One 16 Research and Development 78 Directors’ Report US FDA approval 18 Managing our business responsibly Financial statements 21 Non-financial information 83 Statement of Directors’ Six statement Responsibilities Peer-reviewed publications 22 Financial review 85 Independent Auditor’s Report 26 Legal proceedings 95 Financial Statements 29 Risk management 131 Information for shareholders 28 35 Viability statement Peer-reviewed conference abstracts
2 www.indivior.com We have always understood that access to medication-assisted treatment and counseling is critical to ensure that patients struggling with substance use disorder get the medical care they deserve and need, just like the care provided to patients with other chronic diseases.
With this understanding, we further expand upon our Vision, Mission and Purpose by distilling some of the insights gained from our longstanding journey supporting patients along their path to recovery.
Patients are individuals, and different patients may have different needs. Understanding these needs is critical to supporting patients along their journey to recovery. Stigma, cravings and instability can impact a patient’s chances of recovery. Ultimately, Indivior believes that patients want, need, and deserve reprieve from the cycle of addiction, including: ‹‹ caring and trusted relationships ‹‹ reprieve from constant preoccupation of illicit drug use ‹‹ a means to recover meaning and purpose to life
Indivior works together with addiction thought leaders and stakeholders to expand access to evidence-based treatments, enhance scientific understanding of the disease, and pioneer innovation to drive better patient outcomes.
“Substance use disorder (SUD) is a brain disorder, a chronic disease, which hijacks the brain and can leave patients trapped and suffering. Evidence-based treatment and counseling can help patients find a path to regaining a purposeful and meaningful life.”
Dr. Walter Ling Dr. Ling is a highly recognized thought leader in the treatment of opioid addiction. Professor and Founding Director He has been a continuous grantee researcher of the National Institute on Drug Abuse Integrated Substance Abuse Programs (NIDA) in the US since its inception, and he conducted many of the early, landmark clinical University of California, trials of buprenorphine that provided data for its approval by the U.S. Food and Drug Los Angeles (UCLA) Administration (FDA). Dr. Ling consults with Indivior worldwide. Chair’s statement
“We are committed to helping patients by pioneering innovative and accessible treatments for addiction and its co-occurring disorders.”
At Indivior, we have been on a impacted. As a result, the Group’s net longstanding journey devoted to revenue declined over the prior year transforming addiction from a global and our share price also reflected this human crisis to a recognized and performance. treated chronic disease. The Board, Executive Committee and every The Executive Committee, supported employee are dedicated to realizing by the Board, moved swiftly to our Vision and making it a reality. implement its enterprise contingency We believe that all patients around planning with the goal of ensuring the the world should have access to business remains viable and able to evidence-based treatment for the deliver for patients, and that we can chronic conditions and co-occurring continue to drive value growth. Howard Pien disorders of addiction. Chair While we experienced setbacks, As the global addiction crisis we also made progress toward our continues to grow, we are inspired Vision. In addition to launching by the needs of patients, even amid SUBLOCADE in the US market, the turbulent times for the Group. In Group received its first international 2018, while we made some advances, approval for SUBLOCADE from Health we also experienced several Canada. We remain confident that difficulties including setbacks to the SUBLOCADE will help address Group’s intellectual property related treatment gaps for OUD and we to SUBOXONE® (buprenorphine continue to target $1 billion-plus and naloxone) Sublingual Film of peak annual net revenue from (CIII), which created additional SUBLOCADE. material uncertainty in an already competitive environment. The The Group also received a U.S. February 2018 launch of SUBLOCADE™ Food and Drug Administration (FDA) (buprenorphine extended-release) injection for subcutaneous use (CIII) was impacted, in part, by “As the global reimbursement complexity within the US payor system as the first long- addiction crisis acting injectable (LAI) treatment for opioid use disorder (OUD). Additional continues to grow, barriers to launch acceleration also included the length of the we are inspired prescription journey (time to treat) and, given the entirely new treatment by the needs of paradigm, slower than anticipated Health Care Provider (HCP) trial and patients, even treatment adoption. These barriers are being steadily identified and amid turbulent addressed, however, SUBLOCADE net revenue development was negatively times.”
4 www.indivior.com Strategic report approval for PERSERIS™ (risperidone) With the need to conserve cash in for Extended-Release Injectable “At Indivior, we the face of generic buprenorphine/ Suspension for the treatment of naloxone film entry into the US schizophrenia in adults. PERSERIS have been on market, and the need to fuel our marks an important milestone in future growth drivers (SUBLOCADE the diversification and expansion a longstanding and PERSERIS), we did not make any of our business and commitment direct returns to shareholders. While to patients. Serving patients with journey devoted we continually evaluate Indivior’s schizophrenia is well-aligned with capital allocation priorities, given our Vision; a recent systematic to transforming anticipated ongoing pressure to review and meta-analysis revealed the business, it is unlikely that that the prevalence of any addiction any cash will be directly returned substance use disorder in to shareholders in the near- or treatment-seeking patients from a global medium- term. diagnosed with schizophrenia or first-episode psychosis was 42%.1 human crisis to Changes to the Board a recognized and Yvonne Greenstreet, Non-Executive Despite the challenges faced by Director and Chair of the Science & the business, the Group made the treated chronic Policy Committee, has advised that strategic decision to prudently invest she will step down from the Board in the US market launch of PERSERIS. disease.” and will not seek re-election at the We maintain a peak annual net Annual General Meeting to be held revenue goal for PERSERIS of $200 the profitable long-term growth in May 2019. There are no current to $300 million. we anticipate from SUBLOCADE plans to recruit a successor to and PERSERIS. Dr. Greenstreet and the Nomination You may read more about & Governance Committee will keep SUBLOCADE and PERSERIS in our In relation to the various litigation the composition of the Board and Chief Executive Officer’s statement and investigational matters, the its Committees under close review. on page 12. Group carries a provision for On behalf of the Board, I would like investigative and antitrust litigation to thank Yvonne for her significant Risks, challenges and matters of $438m. Substantially contribution to Indivior. uncertainties all of the provision relates to the As we look ahead, the financial U.S. Department of Justice (DOJ) Outlook impact of generic buprenorphine/ investigation. The Group is in We have aligned the Group to naloxone film entry into the US advanced discussions with the DOJ manage the business challenges market in early 2019 will place the about a possible resolution to its ahead, building in part upon actions Group under further substantial investigations, although it cannot initiated in 2018 and early 2019. top- and bottom-line financial predict with any certainty whether, Looking ahead, we will continue pressure until more progress is when, or at what cost it will reach to develop our business to create achieved with SUBLOCADE and an ultimate resolution. The Board is sustainable long-term value for PERSERIS. highly engaged in these discussions shareholders and wider stakeholders. and has been throughout the process. Addiction remains one of the greatest The Group was prepared for this We continue to cooperate fully with public health crises of our time through contingency planning and the various parties and are hopeful and we are committed to helping actions initiated in 2018 and early for resolution in a timely manner. patients by pioneering innovative and 2019 to streamline the organization accessible treatments for addiction and further reduce costs. These Share price performance and its co-occurring disorders. contingency actions also included and dividend the February 2019 launch by Indivior Finally, I would like to thank all Indivior shares ended the year down of an authorized generic version of my colleagues at Indivior for their 72%, compared with a 15% decline SUBOXONE® (buprenorphine and significant contribution during a for the FTSE 250 Index of which the naloxone) Sublingual Film (CIII) difficult year, and their steadfast Company is a member; this reflects in the US. These preparations will commitment to our shared culture the significant business challenges assist us in remaining compliant and Vision. the Group has faced throughout 2018. with our borrowing covenants and position the Group to leverage Howard Pien Chair
1. Sansone, Randy, Substance Use Disorders and Borderline Personality – Common Bedfellows, 2011 (v1.0) – Page 1, Abstract, Paragraph 1 (p.1) Santucci K, Psychiatric Disease and Drug Abuse, COP 2012 (v1.0) – Page 2, Background, Paragraph 2 (p.2) Santucci K, Psychiatric Disease and Drug Abuse, COP 2012 (v1.0) – Page 2, Background, Paragraph 1 (p.2).
Indivior Annual Report 2018 5 A patient’s journey Ashlynn, US
At Indivior, we believe patient voices are vital in helping to shed light on the opioid epidemic and destigmatize the disease of addiction and other mental health disorders. They also highlight the importance of a full treatment program and provide hope to others. Every patient journey is different, and Ashlynn’s story is uniquely her own.
Ashlynn began treatment for anxiety treatment regimens. She struggled “I hope people will and depression at age 12, although but stuck with it. Each day sober was learn that we are she recalls these feelings at an even a small victory. Working with her younger age without knowing what counselor, she learned about another not just a number. they were. Throughout middle and buprenorphine medication option. At high school, she was treated for these first, she found the treatment painful We can be working mental health disorders, but nothing but since then she has worked with next to you. We seemed to help. Struggling with her healthcare provider to minimize depression as a college freshman, the discomfort and is now in her can be anyone in Ashlynn left university and was ninth month of treatment. She also admitted into a psychiatric ward. attends Narcotics Anonymous and your life.” Leaving treatment, vulnerable and other counseling programs to help still struggling, she snorted her first maintain her treatment protocol Ashlynn prescription opioid analgesic. This and deal with her past. Patient, US led to heroin and a seven-year spiral into opioid addiction, rehabilitation, Now 24, Ashlynn says she is able outpatient and inpatient programs, to focus on other aspects of her and abusive relationships. life, like her family and her full-time job. She is also currently enrolled Ashlynn found herself living in an in a community college working abandoned building, which she toward a certification in addiction pinpoints as the worst experience counseling. Ashlynn hopes to pursue of her addiction. She recalls, ‘I was so a master’s degree and become a scared that I would die, and nobody licensed Professional Counselor would know that I did not want this so that she can help others. life. I knew I needed to change.’ In September 2018, Ashlynn * Ashlynn received compensation from Indivior Ashlynn’s journey to recovery began celebrated being sober for one year. for sharing her story with small steps through various
6 www.indivior.com A patient’s journey Nathalie, US Strategic report Addiction not only impacts patients’ lives, but can also devastate families and relationships, and deprive people of the everyday activities so easily taken for granted. Nathalie’s patient journey to recovery is the story of reuniting with her three children after many years apart, rebuilding her relationships with loved ones and working to create a new life that brings her meaning and joy.
Through all of this, Nathalie’s relationship with her partner of more than eleven years was a constant in her life. He stood by her side, supporting her, forgiving her and trying to help her regain her life and overcome her addiction. She describes ‘putting him through hell’ and it was only when he ended up in hospital for health reasons, and Nathalie was facing the prospect of jail time and being away from him, that she ‘hit rock- bottom.’ Nathalie had tried various medication-assisted treatment options in the past, but she had At 40 years old, Nathalie struggled not changed her ‘people, places “I am embracing with her addiction for over 20 and things.’ She realized that in having my children years before beginning her journey order to truly embrace her recovery to recovery. journey, she would need to make back. They are drastic changes. Already enrolled Nathalie describes growing up in an in a study for a new medication- proud of me, they area where ‘drugs were everywhere.’ assisted treatment option, she was accept me, they She started experimenting with able to join the Drug Court program alcohol and marijuana at age 14 which provided the structure trust me, and we and rapidly progressed to heroin, and psychosocial supports she eventually dropping out of school needed to be successful in the are a family again.” and leaving home. Homeless, she treatment program. describes living between ‘drug Nathalie houses’ and in cars, spending time in Now, after more than 15 years, Patient, US jail and making several unsuccessful Nathalie has all three of her children attempts at treatment. Although she back in her life. She is in school remained sober during each of her to earn her High School diploma, pregnancies, Nathalie lost custody has her driver’s license back and is of her three children when they were driving for the first time since she was very young. a teenager. She is proud of her ‘first real job’ working as a peer counselor She recalls, “I damaged everything at a local community center helping I touched back then. I struggled and patients with Hepatitis C who are fought with my addiction from Day undergoing treatment. She is also One. I used drugs as a way to cope looking forward to getting married to with my life; I used drugs as a way to her long- time partner. numb my feelings. It caused me to do * Nathalie received compensation from Indivior things that I am not proud of. I felt Nathalie has been sober since for sharing her story so alone.” December 2016.
Indivior Annual Report 2018 7 A patient’s journey Miss T, US
Schizophrenia is a chronic and complex medical condition that can affect how a person thinks, feels and behaves. Symptoms include delusions, hallucinations, confused thoughts and speech and difficulty concentrating and remembering things. More than half of all people with schizophrenia have anosognosia or a lack of insight – this symptom makes them unaware they have the illness and complicates treatment. Schizophrenia is typically diagnosed during late adolescence or early adulthood. Miss T was diagnosed in her late teens and we share her story to help raise awareness and understanding of the life-changing and profound personal and family impact of this disease.
By her account, Miss T had a bright She wasn’t convinced doctors had of the group home family. Miss T childhood. Educated at good schools, accurately identified her problems. describes the home and its staff, she was an accomplished ballet As prescribed by her healthcare whose goal is to enable each resident student and a competitive diver. She provider, she would maintain her to have the best quality of life, as graduated with high honors and was treatment regimen. However, as soon “excellent.” She is grateful they are accepted to a prestigious university as she started feeling better, she able to help her navigate life’s daily where she hoped to study law. “I did stopped her medication and would challenges including helping her very, very well until I got my illness,” then find herself back in hospital. remember to take her medicine. she says. The stigma attached to her illness It was through the home that Miss T Just a few months into her first made things even worse. She recalls met a psychiatrist and was enrolled semester at university, she began many people looking down at her, not in a study for a monthly treatment for feeling as though something was taking her seriously, and misjudging schizophrenia. She said the monthly ‘wrong’ with her. She was hearing her. The illness and stigma took away regimen was helpful for her as she voices and seeing things that were all her confidence. sometimes has trouble remembering not there. She withdrew from to take, or if she has taken, her university, and helped by her family, “If you’re high functioning, it’s hard daily medication. pursued treatment which resulted to accept there’s anything wrong in admission to a hospital. with you,” Miss T says. It was only Mostly, Miss T feels people suffering after staying on treatment that she from mental illness need care and “It was like the world was began to understand “there is really understanding from others. She crashing around me all the time,” something wrong with me.” said she is fortunate to have a Miss T recalls. “I wasn’t really nephew who visits her and helps her focusing. People would talk to She was last hospitalized in 2012, feel better about her illness. “His you and it would go in one ear after the stress of losing her parents way of treating me is that ‘you’re and out the other. I couldn’t coupled with a terrible storm that special’,” she explained. “’So, you’re function correctly.” shut off the heat in her apartment paranoid schizophrenic. Everybody’s triggered a nervous breakdown. got something’.” Her diagnosis of paranoid After leaving hospital, she moved schizophrenia in her late teens to a state-licensed personal care forever changed her life. Like many home. She is described by the patients with schizophrenia, Miss T home administrator as “very high * Miss T received compensation from Indivior for had difficulty accepting her illness. functioning” and a loved member sharing her story.
8 www.indivior.com Strategic report
“You should never let your illness take over what you want to do because you could be the person that makes a difference in someone’s life.”
Miss T Patient, US
Indivior Annual Report 2018 9 Business model
Patient needs inspire us
Our people, culture, expertise and insight, coupled with our innovative technology and stakeholder relationships, uniquely position us to help address patients’ unmet needs around the world.
Indivior Our assets
Our Purpose Highly skilled and knowledgeable people is to pioneer Indivior has an able workforce and management team with a life- transforming treatment. deep understanding of patient needs and a strong commitment to improving patient lives. Our Vision that all patients around the world Culture have access to evidence-based Based on a clearly-defined set of Guiding Principles, Indivior’s treatment for the chronic conditions culture is a key competitive advantage enabling Indivior to drive and co-occurring disorders strategic business growth and create social value. of addiction. Product portfolio Our Mission Indivior’s product portfolio is focused on helping meet patient is to be the global leader who is a needs in addiction and schizophrenia. pioneer in developing innovative prescription treatments for Intellectual property addicted patients. Indivior has a unique portfolio of licenses and patents which provide a platform for the creation of long-term value.
Financial capital Indivior employs disciplined asset allocation with a focus on retaining a robust capital base to ensure flexibility in addressing legal matters, agility in managing unknown market impacts, and the ability to pursue growth opportunities.
$91m* Invested in R&D * includes exceptional costs of $24m 44 28 See page 13 for our Countries where we have Peer-reviewed Guiding Principles a global presence conference abstracts
10 www.indivior.com Strategic report
How we generate value Indivior advocates to increase global understanding and awareness, destigmatize the disease and expand The global addiction crisis has treatment access. provided an opportunity for the Group to significantly expand the market for buprenorphine medication-assisted treatments, which is increasingly recognized Advocacy as an effective and evidence-based treatment for OUD. By leveraging our capabilities, we are also now serving patients with schizophrenia Stakeholder which is a well-aligned adjacency for engagement our business. Strong and enduring relationships with key Stakeholder engagement stakeholders For more than 20 years, Indivior has worked together with policymakers, medical societies, patient advocacy Sales and Research and groups, healthcare providers, marketing Patient development payers and other stakeholders. Carefully managed World-class treatment These relationships provide Indivior compliance and adherence needs to good practice innovation with critical insights to develop and enhance its patient-focused business approach.
Research and development Manufacturing Our aim is to advance treatment Producer of high quality innovation by developing new medicines patient-focused treatments, including enabling the Group to expand the scope of treatment it provides to help Gu s idi lue address the co-occurring disorders ng P e va rincipl nd cor of addiction. es a
Manufacturing Our aim is to improve the lives of patients through an uninterrupted Meeting patient needs supply of high-quality products. Leveraging its deep understanding of patient needs, Indivior is committed Sales and marketing to addressing the global addiction crisis by expanding the availability of its patient-focused treatments, including treatment access, while also leveraging Our aim is to deliver high-quality its scientific expertise to develop novel treatment. products and accurate information, and maintain strong and credible relationships with customers and key stakeholders.
Indivior Annual Report 2018 11 Chief Executive Officer’s statement
“Moving forward, our primary focus is to achieve commercial success in the US growth market and leverage our established leadership position. We believe Indivior is appropriately positioned to make progress toward meeting patient needs in addiction and its co-occurring disorders.”
In the face of these immediate ‹‹ Developing and fortifying the challenges, however, we made business: While broader mergers progress against the strategic and acquisition activity, other priorities set for the Group by than early stage asset licensing, the Board and the Executive is currently on hold, Indivior used Committee, with the understanding a portion of its cash balance to that building upon them positions voluntarily prepay $235 million of Indivior to generate long-term outstanding term loan principal to shareholder value: significantly improve the overall financial flexibility and the ‹‹ Building the resilience of our resilience of the Group. franchise: Positioned the business Emerging from a turbulent 2018, we Shaun Thaxter to deliver new net revenue from believe Indivior is positioned for Chief Executive Officer SUBLOCADE and PERSERIS™ in continued progress toward meeting the US while seeking to maintain patient needs in addiction and 2018 marks one of the most cash flow from SUBOXONE® Film’s challenging periods for our business schizophrenia. Neither our Vision nor share of the US buprenorphine our strategy for realizing our Vision at Indivior. The well-understood risk medication-assisted treatment of generic buprenorphine/naloxone has changed. With this in mind, let us market; with generic manufacturer consider progress made against these sublingual film competition in our film entry in the US, in February largest market created additional strategic priorities and the intended 2019, launched an authorized path forward: material uncertainty in an already generic version of SUBOXONE® competitive environment. This Film in the US. development, and the slower than Our innovative growth products expected launch trajectory of ‹‹ Developing our innovative pipeline: SUBLOCADE™ (moderate-to- SUBLOCADE™, is reflected in our Launched SUBLOCADE in the US severe opioid use disorder) lower net revenue (-8%) and adjusted and established a new specialty Our long-term growth and net income, which was essentially infrastructure; achieved marketing profitability will largely be driven unchanged compared with 2017. approval of PERSERIS for the by SUBLOCADE. With this pioneering treatment of schizophrenia by US technology, our goal is to produce 2018 net revenue by geography FDA and made it available in 2018; better patient outcomes and help identified and licensed early stage drive a paradigm shift in the large pre-clinical pipeline assets that and growing market for the treatment have the potential to address the of OUD in the US. SUBLOCADE unmet needs of patients across delivers consistent buprenorphine substance use disorders (SUD). plasma levels over the treatment ‹‹ Expanding global treatment: period resulting in an occupancy of $1,005m Achieved marketing approval of greater than 70% of the mu opioid SUBLOCADE by Health Canada and receptors. SUBLOCADE may also successfully submitted regulatory be a useful alternative for patients filings for SUBLOCADE in Australia, that have difficulty adhering to a New Zealand, and Europe; achieved daily medication treatment. The United States marketing approval for SUBOXONE® U.S. FDA and others have indicated est of orld Sublingual Tablets in China. that sustained-release injectable depots of buprenorphine can provide
12 www.indivior.com Strategic report effective treatment of OUD that may SUBLOCADE, to grow. Our confidence market. As such, our immediate goal be less subject to misuse, abuse is supported by the positive is to educate HCPs, patients and or accidental exposure compared anecdotal feedback we continue to caregivers on the characteristics of with self-administered formulations receive from patients and HCPs. PERSERIS and ensure there are no such as transmucosal tablets significant barriers to access. and films.1, 2 PERSERIS™ (schizophrenia) Following the July 2018 marketing SUBOXONE® Film Early in the SUBLOCADE launch, approval by the US FDA, PERSERIS has Despite continued competition from we recognized that we had launched in the US for the treatment manufacturers of generic SUBOXONE® underestimated the level of of schizophrenia in adults. PERSERIS Tablets and the market impact of reimbursement complexity for this leverages our proprietary ATRIGEL® Dr. Reddy’s Laboratories Ltd.’s (DRL) new treatment option in the addiction delivery system to provide sustained initial generic buprenorphine/ disease space. This complexity, plasma levels of risperidone – still naloxone sublingual film launch, coupled with the length of the the most prescribed anti-psychotic we maintained cash flow from prescription journey (time to treat) medicine in the US – over the SUBOXONE® Film’s share of the and slower than anticipated HCP trial monthly dosing interval after US buprenorphine medication- and treatment adoption, resulted in subcutaneous administration. Clinical assisted treatment market (BMAT) net revenues coming in below our trials of PERSERIS were designed for and a leading position in the US with expectations for 2018. We worked the product to be initiated with no an average market share of 53% tirelessly throughout the year to loading doses with the potential for (2017: 57%). identify and break down obstacles improved compliance inherent in for SUBLOCADE patients and HCPs LAI technologies. In February 2019, upon confirmation and saw steady improvement in of the launch of generic payer approval rates and treatment With PERSERIS, we offer a long-acting buprenorphine/naloxone dispense rates. Although initially treatment for schizophrenia which we sublingual film products, Indivior frustrating, the new specialty believe also creates an opportunity launched an authorized generic infrastructure we have established to serve patients in a well-aligned of SUBOXONE® Film. for SUBLOCADE is a competitive adjacency that provides Indivior advantage that we anticipate realizing diversification in its portfolio. Maintaining our disciplined in the coming years as familiarity of capital allocation the expected benefits of this new The US demand for LAIs is projected In 2018, we continued to maintain treatment paradigm grows among to continue at strong double-digit a sufficient level of cash to fortify patients and HCPs alike. rates and this remains an Indivior against additional generic underpenetrated segment in manufacturer competition and legal Our primary focus moving forward the fast-growing market for proceedings and ended the year is to leverage our established anti-psychotics. While we are a with cash of $924 million. We also leadership position in OUD treatment new market entrant to this disease voluntarily prepaid $235 million of to help drive commercial success space/category, in contrast with our outstanding loan principal during in the US growth market. Over the initial experience with SUBLOCADE, the year to bring our outstanding medium to long-term, we expect where we had to establish much of debt level below $250 million. recognition of the potential benefits the specialty infrastructure, LAIs are offered by LAI technologies, such as frequently used in the anti-psychotic
Our Guiding Principles “While it is easy to live our Guiding Principles Focus on patient needs Seek the wisdom during the good times, to drive decisions of the team it is a true test to Believe that people’s remain committed Care enough actions are well to coach to these principles when intended times are difficult. I am Demonstrate See it, own it, particularly proud of honesty and integrity make it happen at all times our patient-focused culture which continues 1. Nikolaj Kunøe, Joshua D Lee, Opioid addiction: long-acting formulations for a long-term disorder – www.thelancet.com Published Online February 18, 2019 http://dx.doi.org/10.1016/S0140-6736(18)32428-0. to inspire all that we do.” 2. Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment Guidance for Industry prepared by the Division of Anesthesia, Analgesia, and Addiction Products in the Center for Drug Evaluation and Research at the Food and Drug Administration Published February 2019 https://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Indivior Annual Report 2018 13 Chief Executive Officer’s statement continued
2018 Year at-a-glance
Strategic Progress priorities in 2018
Building the ‹‹ Launched SUBLOCADE™ in Q1 and contributed net revenue of $12 million in resilience of FY 2018 ‹‹ Established new specialty infrastructure for SUBLOCADE; achieved 83% payer our franchise coverage; key performance indicators (KPIs) showed steady improvement through FY 2018 ‹‹ Positioned the business to deliver new net revenue from SUBLOCADE and PERSERIS™ while maintaining leading BMAT share and cash flow from SUBOXONE® Film, despite continued competition from manufacturers of generic SUBOXONE® Tablets average market share was 53% (2017: 57%) ‹‹ Expanded treatment capacity to a record number of physicians and other qualified treatment providers in the US, ending the year at approximately 61,500 HCPs – a 27% increase
Developing ‹‹ Continued progress on Health Economics and Outcomes Research (HEOR) and Lifecycle Evidence Generation & Optimization (LEGO) studies supporting our innovative SUBLOCADE; findings expected to be shared in key publications and conferences pipeline throughout FY 2019 ‹‹ Received approval of PERSERIS from the US FDA for treatment of adults with schizophrenia in the US; treatment made available late November 2018 ‹‹ Realized a $37 million gain in FY 2018 from the exclusive out-licensing of patents related to nasal naloxone ‹‹ Identified and licensed early stage pre-clinical pipeline assets that have the potential to address the unmet needs of patients across SUD
Expanding ‹‹ Achieved SUBLOCADE market approval in Canada global ‹‹ Successful SUBLOCADE filings in Australia, Israel, New Zealand, and Europe treatment ‹‹ Received approval for SUBOXONE® Sublingual tablets by the Chinese National Medical Products Administration (NMPA) for the treatment of OUD and announced an agreement to divest the rights to SUBOXONE® Tablets in China ‹‹ Maintained SUBOXONE® Tablet’s leading share of BMAT market in Europe, Indivior’s largest market outside the US
Developing ‹‹ Broader mergers and acquisition activity, other than early stage licensing, and fortifying is currently on hold the business ‹‹ Voluntarily prepaid $235 million bringing the term loan principal to $243 million ‹‹ Exited 2018 with a cash balance of $924 million; in order to maintain a strong cash balance to fund the commercial success of SUBLOCADE and PERSERIS while remaining within our debt covenants ‹‹ Undertook initiatives to reduce operating expenses, including headcount reductions, research and development (R&D) reprioritization and other committed savings ‹‹ Prepared to launch an authorized generic version of SUBOXONE® Film in the US as part of contingency planning
14 www.indivior.com Strategic report These preparations will assist Asserting Indivior’s Conclusion Indivior, even with market entry of intellectual property One of the great characteristics of generic film products, to fund the Indivior continues to assert its Indivior is that we always make the best commercial success of SUBLOCADE intellectual property rights protecting of circumstances, however challenging, and PERSERIS and remain within our SUBOXONE® Film. We continue to including those precipitated by events debt covenants. await the outcome of the appeal of beyond our control. Our commitment the non-infringement judgments to making progress toward our Vision, Streamlining the organization related to US Patent Nos. 8,603,514 together with the decisive actions we We have streamlined Indivior’s and 8,017,150, which will be heard in have taken, will help ensure we remain organization in response to H1 2019, as well as ongoing litigation a strong and durable company. anticipated near-term revenue against DRL, Alvogen, and Teva in the pressures that are expected to District of New Jersey, and against ‹‹ We have put in place the arise with the launch of generic Actavis in the District of Delaware, foundational elements for alternatives to SUBOXONE® Film asserting the more recent Orange profitable growth. The most in the US. We were very thoughtful Book-listed patents, including US important driver is SUBLOCADE, in the choices we made to ensure Patent No. 9,931,305. Please refer to but with the launch of PERSERIS that we maintained the capabilities page 26 for further information on for the treatment of schizophrenia necessary to support the commercial legal proceedings. we are gaining diversification success of SUBLOCADE and PERSERIS. and additional potential Partially with savings achieved from Given our year-end cash position of revenue growth. a substantially reduced cost base, we $924 million and the savings achieved ‹‹ We have streamlined the were able to make PERSERIS available as a result of our organizational organization to respond to in the US and begin to advance realignment, Indivior is positioned pressures we face with generic toward our goal of diversifying to withstand the material and rapid film competition in the US market. Indivior’s revenue base. market share loss that our SUBOXONE® The result is a significantly reduced Film is likely to experience now that cost base that we can leverage The streamlining actions we generic film manufacturers have as expected net revenue growth undertook impacted Indivior’s global entered the market. We will also seek from SUBLOCADE and PERSERIS workforce. While there is no good way redress and damages from any “at- materializes. In February 2019, we to implement changes such as these, risk” launch, following success in any launched an authorized generic we were able to move through the outstanding cases. version of SUBOXONE® Film in process as sensitively and efficiently the US to capture share of the as could be expected. I am extremely Our patient-focused culture generic segment. proud of the professionalism Delivering on patient needs and dignity demonstrated by our continues to inspire us at Indivior. ‹‹ Our US market remains strong, colleagues who were impacted by We are encouraged that around with good growth expected, and these actions and departed from the world OUD is being increasingly we are maintaining our strong the business. While it is easy to live recognized as a treatable medical patient advocacy to expand OUD our Guiding Principles during the disease, and not a moral failing. Our treatment access globally. good times, it is a true test to remain collective passion to help patients ‹‹ Patient needs continue to inspire committed to these principles when suffering from stigmatized and us at Indivior. This remains the times are difficult. socially marginalized diseases will core of everything we do, along be a key strength as we work to bring with ensuring we drive Indivior’s Strengthening our PERSERIS to adult patients. long-term success ethically commitment to compliance and responsibly. In 2018, we sustained our long-term In 2018, we were able to support a commitment to compliance. We series of regulatory and legislative Of course, none of our progress or the were pleased to welcome Cindy developments in the US intended treatment we offer patients would be Cetani to the newly created Executive to improve treatment access for possible without the hard work of our Committee leadership position patients and allow HCPs to care for employees. The passion and dedication of Chief Integrity and Compliance more patients when they decide to they demonstrate each day is truly Officer. Cindy brings more than 30 seek help. We expect to see ongoing inspirational. I would like to take this years of experience in driving a expansion in the OUD treatment opportunity to thank all my colleagues culture of learning and integrity, and market as awareness, attention, and for their unwavering commitment to compliance program vision. Cindy addiction disease normalization our Vision and to our patients. joins us from Novartis, where she grows, and more patients are able to held roles of increasing responsibility access treatment. Yours sincerely, over the past 15 years and was most recently Head of Compliance Shaun Thaxter Operations, Group Integrity Chief Executive Officer and Compliance. Indivior Annual Report 2018 15 Research and development
“We believe that integrated clinical development programs actively engage patients and their communities, and will progressively break down barriers and misconceptions about substance use disorders and their treatment.”
One of our core guiding principles, The FDA approval of SUBLOCADE™ in focus on patient needs to drive November 2017 and the approval of decisions, incentivizes our Research SUBLOCADE in Canada in November and Development (R&D). Our aim is to 2018 were the most recent steps advance treatment innovation in the in a long commitment to better face of the growing global addiction understand how to address the needs crisis. We do this by focusing on of patients suffering from OUD. Our continuity of care, monitoring patient pivotal Phase 3 data demonstrating progress in the short-, medium- and the clinical efficacy, safety and long-term, and understanding better tolerability of SUBLOCADE were the underlying causes of relapse. recently published in The Lancet.5 In 2018 Indivior also initiated Christian Heidbreder Despite availability of medications the planning and execution of Chief Scientific Officer to treat OUD, data derived from the post-marketing and lifecycle 2012-2013 National Epidemiologic management strategies along Survey on Alcohol and Related five main pillars: Conditions – III (NESARC-III) showed only 30% of those with lifetime 1. Post-marketing requirement non-medical prescription OUD have (PMR) studies: These studies aim ever received treatment.1 For those to understand better the patient receiving treatment, comorbidities populations that may benefit (e.g. alcohol use disorder, non-opioid from a higher maintenance dosing drug use disorder, schizophrenia, regimen of SUBLOCADE and to and/or bipolar disorder and explore how SUBLOCADE can be chronic pain) and high rates of safely initiated without a period of non-adherence have been associated sublingual buprenorphine titration. with increased odds of relapse and higher total healthcare costs.2, 3, 4 2. Post-marketing commitment (PMC) studies: These analyses compare the safety and efficacy of SUBLOCADE given monthly vs. SUBLOCADE given at a longer inter-dose interval. They also aim to evaluate the transition of patients with long-term stability on a transmucosal buprenorphine dose to a monthly dose of SUBLOCADE.
1. Saha TD et al. Nonmedical Prescription Opioid Use and DSM-5 Nonmedical Prescription Opioid Use Disorder in the United States. J Clin Psychiatry 2016; 77:772-80. 28.92 (2.07). 2. Tkacz J et al. Compliance with buprenorphine medication-assisted treatment and relapse to opioid use. Am J Addict 2012; 21:55-62. 3. Ronquest NA et al. Relationship between buprenorphine adherence and relapse, health care utilization and costs in privately and publicly insured patients with opioid use disorder. Subst. Abuse Rehabil. 2018; 9:1-20. 4. Compliance with Buprenorphine Medicated-Assisted Treatment and Relapse to Opioid Use (v1.0) – Anchor 1 (p.6). 5. Haight BR, Learned SM, Laffont CM, Fudala PJ, Zhao Y, Garofalo AS, Greenwald MK, Nadipelli VR, Ling W, Heidbreder C (2019) Efficacy and safety of a monthly buprenorphine depot injection for opioid use disorder: a multicentre, randomised, double-blind, placebo-controlled trial. The Lancet, 393(10173):778-790. https://doi.org/10.1016/S0140-6736(18)32259-1. 16 www.indivior.com Strategic report 3. Lifecycle evidence generation Addressing co-occurring and optimization (LEGO) studies: disorders of addiction “Focusing on These studies aim to: Epidemiological and clinical studies the importance ‹‹ demonstrate that craving have shown that substance use can potentially be used as disorders are highly comorbid of continuity of an endpoint to predict illicit with psychiatric disorders. care, monitoring opioid use; These disorders include anxiety, depression, bipolar disorder, patient progress ‹‹ study the effects of initiating attention-deficit hyperactivity SUBLOCADE treatment in disorder, borderline personality in the short-, emergency rooms to prevent disorder, antisocial personality medium- and repeated opioid overdoses and disorder, and schizophrenia.7 A recent potentially change standards of systematic review and meta-analysis long-term, providing care; and revealed that the prevalence of any ‹‹ investigate if high plasma substance use disorder in treatment- evidence-based concentrations of buprenorphine seeking patients diagnosed with training to similar to those delivered by schizophrenia or first-episode SUBLOCADE may reduce the psychosis was 42%.8 health-care effects of respiratory depression produced by fentanyl, which has In July 2018, Indivior received providers, and been increasingly and directly FDA approval for PERSERIS™, the understanding related to drug overdose deaths first once-monthly subcutaneous in the US. risperidone-containing long-acting better the injectable for the treatment of 4. Patient-reported outcomes schizophrenia in adults in the US. underlying causes research and health economics: Following FDA approval, we initiated of relapse are Indivior has invested a substantial the planning and execution of post- amount of time and effort into the marketing and lifecycle management the hallmarks of integration of patient-reported strategies in support of PERSERIS. outcome measures as part of our mission and its clinical development plans. A holistic approach to vision in addiction For example, we have launched addiction medicine Remission from Chronic Opioid Beyond the development medicine.” Use: Studying Environmental and of treatments for OUD and Socioeconomic Factors on Recovery schizophrenia, Indivior is (also known as the RECOVER Study), pioneering therapies to address which is collecting up to 24-month the unmet needs of patients longitudinal data encompassing struggling with SUD. To that end, demographics, drug use, drug we are investigating innovative treatment, family relationships, approaches that selectively target quality of life, mental and physical the γ-aminobutyric acid type B 9 health, healthcare utilization, crime, (GABAB) receptor , the orexin-1 housing, employment, and urine receptor10, and the dopamine D3 drug screening.6 receptor11 in partnership with Arbor Pharmaceuticals, Addex Therapeutics 5. Regulatory filings outside the US: (Addex), C4X Discovery, and Aptuit. Filings were made in Australia Plans are being implemented to (May 2018), Israel (July 2018), New accelerate our backup program (new Zealand (September 2018), and lead identification and optimization) Europe (November 2018). in partnership with Addex.
6. Ling W et al. Remission from Chronic Opioid Use – Studying Environmental and Socio-economic Factors on Recovery (RECOVER): study design and participant characteristics. Contemporary Clinical Trials, 2019; 76:93-103. Remission from Chronic Opioid Use: Studying Environmental and Socioeconomic Factors on Recovery (v1.0) – Table 3: Schedule of Assessments (p.23). 7. Sansone, Randy, Substance Use Disorders and Borderline Personality – Common Bedfellows, 2011 (v1.0) – Page 1, Abstract, Paragraph 1 (p.1) Santucci K, Psychiatric Disease and Drug Abuse, COP 2012 (v1.0) – Page 2, Background, Paragraph 2 (p.2) Santucci K, Psychiatric Disease and Drug Abuse, COP 2012 (v1.0) – Page 2, Background, Paragraph 1 (p.2). 8. Hunt GE et al. Prevalence of comorbid substance use in schizophrenia spectrum disorders in community and clinical settings, 1990-2017: Systematic review and meta-analysis. Drug Alcohol Depend. 2018; 191:234-258. 9. Padgett CL et al. Methamphetamine-evoked depression of GABA(B) receptor signaling in GABA neurons of the VTA. Neuron 2012; 73:978–989. 10. Perrey DA & Zhang Y. Therapeutics development for addiction: Orexin-1 receptor antagonists. Brain Res. Epub Aug 24, 2018. 11. Heidbreder C. Rationale in support of the use of selective dopamine D₃ receptor antagonists for the pharmacotherapeutic management of substance use disorders. Naunyn Schmiedebergs Arch Pharmacol. 2013; 386(2):167-176. Indivior Annual Report 2018 17 Managing our business responsibly
The Group’s approach to managing the business responsibly drives the delivery of its mission, vision, strategy, risk management, governance, management systems and performance monitoring.
We seek to continuously improve 1. Environment, climate change by the substance use disorder of our standard operating procedures, and health and safety family members, with the aim of management systems and The Group’s main impacts are linked breaking the intergenerational cycle performance indicators. to our fine chemical plant in Hull. of addiction. Our facilities have an excellent track This section provides an overview of record and recorded no material Our grant supports the strengthening, Indivior’s framework which addresses environmental (e.g. spills, emissions growth, and expansion of addiction six key areas of its business: to air) or health and safety incidents prevention resources, sites during 2018. and services. 1. Environment, climate change and health and safety Emissions Indivior also supports Camp Mariposa 2. Communities through its employee volunteering Type Tonnes of CO2e programs including collecting and 3. Patient safety and product quality Scope 1 473 donating hygiene supplies and duffle 4. Business conduct Scope 2 location-based 2301 bags, contributing direct volunteer 5. People Scope 2 market-based 2599 hours, and collecting funds for 6. Advocacy and stakeholder Scope 3 157 camp supplies for Camp Mariposa’s engagement 12 locations. Total emissions Reporting, investor dialogue location-based 2932 3. Patient safety and and ratings Total emissions product quality market-based 3230 The Group is in regular dialogue Patient safety and product quality are with its investors about its approach Per tonne of production embedded in the Group’s culture and to responsible business. We also location-based 583 patient-focused business model, and participate in several related Per tonne of production are fundamental to the integrity of research exercises conducted by market-based 642 our global brands and businesses. organizations such as CDP, FTSE Per full time employee 1 Through a robust pharmacovigilance Russell, VigeoEIRIS and MSCI. location-based 3.2 process, we monitor the safety of the The Group has been a member of Per full time employee Group’s marketed and investigational the FTSE4Good index series since it market-based 3.5 products in a comprehensive and became independent and recently thorough manner. This includes a Risk received a comparably high ESG 2. Communities Evaluation and Mitigation Strategies rating in comparison to several of its Camp Mariposa (REMS) program to mitigate the risks 2 of accidental overdose, misuse and significantly larger peers from MSCI. In September 2016, Indivior entered abuse for SUBOXONE® Film and to into an agreement with the Eluna mitigate the risk of serious harm Network (formerly the Moyer or death that could result from Foundation) to provide a three-year intravenous self-administration for grant to support Camp Mariposa, SUBLOCADE™ in the US. Globally, Risk Eluna’s addiction prevention Management Plans (RMPs) are being and mentoring program. Camp put in place to minimize risks outside Mariposa serves youth impacted the US.
1. Information about FTSE4Good membership verified by email from FTSE Russell on July 6, 2018. 2. Information about MSCI ratings verified in ESG ratings report received from MSCI dated September 24, 2018. 18 www.indivior.com Strategic report The Group is committed to a Health and Human Services, and 5. People culture of innovation and quality the appropriate industry codes of The Group has a variety of defined as maintaining patient ethics, including those published employment policies that create trust, empowering our workforce by the Pharmaceutical Research a framework to ensure that it is and partnering with regulators to and Manufacturers of America an employer of choice and that drive excellence. (PhRMA); Association of the British it provides a fair, equitable and Pharmaceutical Industry; and by conducive working environment Patient Help Foundation Medicines Australia. free from discrimination and In 2018, the Indivior Patient Help harassment. The Group views its Foundation provided SUBOXONE® In 2018, the Group continued to employees as fundamental to its Film product valued at $16.7m enhance its Integrity and Compliance long-term success and strives to through its patient assistance program through the implementation provide a working environment in program in the US. Since 2010, the of the following (among other key line with this ambition. It conducts a Foundation has provided medication deliverables): variety of communications, training access to an average of 5,000 and development programs to qualified patients per year. ‹‹ undertaking a comprehensive achieve this aim and to ensure that review of key internal processes, employees conduct their activities 4. Business conduct including implementation of in line with the Group’s Guiding appropriate enhancements; The Group requires compliance Principles. These include: with laws, regulations, and industry ‹‹ conducting ‘distributor country’ codes of conduct at all times via compliance training and supported ‹‹ culture champions program; established policies and procedures. multiple distributor audits; ‹‹ regular performance reviews; and Its comprehensive compliance ‹‹ developing and disseminating an ‹‹ local town hall program includes a focused Integrity enterprise-wide quarterly Integrity communications events. and Compliance department, with and Compliance newsletter to our Chief Integrity and Compliance drive awareness and best practice As of December 31, 2018, Indivior Officer as a member of the Executive throughout the organization; employed 915 people worldwide Committee. The Integrity and (2017: 1,023). The distribution of Compliance department helps ‹‹ adopting gamification as an these people by function and assure that the Group’s operations approach to reinforce the field- location is shown on page 20. are conducted in line with all legal based sales team’s knowledge of and regulatory requirements, and compliance with policies; and guidance from the Office of Inspector ‹‹ appointing the Executive General for the U.S. Department of Committee to serve as the Indivior Compliance Committee.
Compliance leadership As Chief Integrity and Compliance Joining Indivior in October 2018, Cindy Officer, Cindy Cetani will continue more than 30 years of experience in to leverage the Group’s strong driving a culture of learning, integrity commitment to compliance and and compliance program vision. its culture of integrity. Reporting Cindy joined Indivior from Novartis, to the Chief Executive Officer, where she held roles of increasing Cindy will focus on compliance responsibility over the past 15 program strategy, governance and years and was most recently Head sustainability, related strategic of Compliance Operations, Group and integrated communications, Integrity & Compliance. workforce continuing education and development, and ongoing risk awareness and management to help assure compliance with relevant laws, regulations and industry codes of conduct.
Indivior Annual Report 2018 19 Managing our business responsibly continued
Territories Our gender diversity figures for the purposes of s414C(8)(c) of the Companies Number Act 2006 are as follows:
United States of America 573 At December 31, 2018 Total Women Men Australasia 27 Directors of Indivior PLC 11 4 36% 7 64% China 6 Senior managers* 59 18 30% 41 70% Europe, Middle East, Africa All employees 915 497 54% 418 46% and Canada 309 * Includes members of the Executive Committee who are not Directors of Indivior PLC and all subsidiary company directors Employment function Number understanding of the Group’s of the Group before the US House activities, strategy, products and of Representatives Energy and Commercial 429 plans and to further develop the Commerce Subcommittee on Health Compliance 9 relationship between the Group’s hearing on ‘Combating the Opioid Corporate affairs and senior management team and Crisis: Helping Communities Balance communications 7 its employees. Enforcement and Patient Safety’. Finance 76 This hearing helped establish the All the events were attended and policies ultimately included in H.R.6. Human Resources 23 led by members of the Group’s ‘‘New innovations are expanding Information Technology 41 Executive Committee, including the medication-assisted treatment Legal and governance 14 Chief Executive Officer, and were options,” the Chief Medical Officer video conferenced to enable the stated during her testimony. Medical 86 participation of staff located at “Government policies impacting Research and development 133 different sites. these treatments must adapt to Supply 97 ensure patients have access to all International Women evidence-based treatment options.”1 Culture champions in Leadership Enacted on October 24, 2018, this The Group’s culture champions are The Group’s international women in leadership program is called IWiL law includes multiple, comprehensive a network of nearly 50 employees initiatives to improve access to from around the world who act as and its mission is to help support diversity in leadership. The program treatment for patients suffering ambassadors and create opportunities from substance use disorders.2 for greater engagement and sharing is conducted within each territory of best practices. Champions are and consists of a variety of events, activities and communications The Chief Medical Officer also tasked with proposing ideas and participated in the US State implementing activities to drive a initiatives. During 2018, these activities included: Government Affairs Council Leaders positive culture, in collaboration Policy Conference on Innovations with Human Resources, managers ‹‹ networking events at Group sites; in Healthcare panel entitled and leaders. ‘Revolutionary Treatments for ‹‹ access to training videos and Society’ in 2018. At the conference, To reinforce its culture and Guiding a business skills library; she underscored the importance Principles, in 2018 the Group ‹‹ mentoring activities; and of understanding the patient implemented an on-line training journey and giving patients and ‹‹ development of volunteering program to supplement the live their healthcare providers access opportunities. classroom training. Employees are to the full range of evidence- now expected to complete both based therapies. modules to understand and quickly 6. Advocacy and stakeholder engagement begin exemplifying our values and In 2018, Indivior also supported a Guiding Principles. In 2018, Indivior continued range of non-governmental agencies engaging with stakeholders and and campaigns around the world Town hall events advocating for patients to help to help destigmatize and raise During the year, the Group held stimulate and accelerate changes awareness of the disease of addiction several town hall events across to public policy. In the US, Indivior and other mental health disorders. our global regions and functions, supported the passage of H.R.6, Indivior also supported efforts to including several global Skype the SUPPORT for Patients and develop resources for patients, broadcast meetings. These Communities Act. Indivior’s Chief families and communities. events serve as two-way dialogue Medical Officer testified on behalf opportunities to improve employee
1. https://docs.house.gov/meetings/IF/IF14/20180228/106915/HHRG-115-IF14-Wstate-SubbiahP-20180228.pdf. 2. https://www.congress.gov/bill/115th-congress/house-bill/6/all-info?r=l. 20 www.indivior.com Non-financial information statement Strategic report The Group is committed to where further relevant information, Business model transparency concerning its other than that disclosed within An explanation of the Group’s corporate responsibility impacts and this report can be accessed. In business model can be found on opportunities, the disclosure of other particular, the Group provides the pages 10 and 11 of this annual report. non-financial information where it is responsibility section of its website relevant to shareholders and other (www.indivior.com) for this purpose, Description of principal risks, key stakeholders, and to complying participates in the annual disclosure and impact of business activity with the reporting requirements of environmental and climate change contained in sections 414CA and information to CDP (www.cdp.net), A description of the principal risks 414CB of the Companies Act 2006. and regularly enters into dialogue and potential adverse impacts with investors and investor research relating to this aspect of the business The table and other information organizations (including MSCI and can be found on pages 29 to 34 of this below are provided to assist readers FTSE Russell) about this aspect of annual report. We have included a of this report to understand the its activities. table below which cross-references Group’s approach, policies, and this information in detail. performance. It also aims to highlight
Other reporting Policies and statements of approach, Risks, risk management and Non-financial performance requirements due diligence and outcomes additional information information Environment ‹‹ Environmental policy Environmental impacts p18 Greenhouse gas and climate emission information p18 change Social ‹‹ Health and safety policy Reporting and investor dialogue p18 Investor ESG ratings information p18 matters ‹‹ Flexible working policy Health and safety impacts p18 Health and safety data p18 ‹‹ Data protection policy Integration of advocacy, patient needs and stakeholder engagement Indivior Patient Health ‹‹ Healthcare professionals into the business model p11 Foundation p19 interaction policy Patient focused culture p15 Employee data p19-20 ‹‹ Healthcare business ethics policy Community investment in Camp Mariposa (Eluna Network) p18 ‹‹ Share dealing policy and code Patient safety and product quality p18 ‹‹ Field medical personnel policy Human Resources p19-20 ‹‹ Records and information Business operations risk management policy information p31 ‹‹ Advocacy and public policy People information p80 Human ‹‹ Diversity and inclusion policy International Women in Leadership Employee gender program p20 diversity figures p20 rights ‹‹ Modern Slavery Statement Advocacy activities p20 Business ‹‹ Anti-bribery policy Business conduct Political donations p81 and compliance p19 conduct ‹‹ Whistleblowing policy Legal proceedings p26-28 Regulatory and safety risk information p31 Supply chain risk information p33 Legal and intellectual property risk information p33 Compliance risk information p34 Whistleblowing system p55
A summary of the Group’s policies in these areas are The Group also has a Code of Conduct which addresses available within the responsibility sections of the Group’s many of the stated policy areas and is available for website (www.indivior.com). There is also a link to the download from the corporate governance section of the Group’s UK Modern Slavery Act 2015 statement at the foot Group’s website. of the home page. Indivior Annual Report 2018 21 Financial review
% ∆ % ∆ ‹‹ The Group continued in advanced Period to December 31st FY 2018 FY 2017 Actual Constant (as reported) $m $m FX FX discussions with the DOJ about a possible resolution to its Net revenue 1,005 1,093 -8 -9 investigations. See Note 20 and Operating profit 292 193 +51 +48 Note 22 for further details on Net income 275 58 * * provisions and legal proceedings. EPS (cents per share) 38 8 * * * Not meaningful Operating highlights ‹‹ Net revenue of $1,005m, a decrease of 8% versus prior year (-9% at et evenue 1 Ad usted et ncome constant exchange). US market , growth was more than offset by US SUBOXONE® Film share loss, , targeted rebating and mix impact from growth in government channels (Medicaid). , ‹‹ Operating profit was $292m (2017: US ollars m US ollars m $193m). On an adjusted basis, 1. excluding exceptional items operating profit was $332m, a (further details on page 25) decrease of 18% (Adj. 2017: $403m). Lower net revenue and higher as alance et as SUBLOCADE and PERSERIS launch investments were partially offset by impacts from operating expense reductions. ‹‹ Net income was $275m (2017: $58m). On an adjusted basis, 2018 net income was $272m +1% (Adj. 2017: US ollars m US ollars m $270m). Lower adjusted operating profit was more than offset by Key operating developments ‹‹ Indivior has been preparing for this lower net financing costs and ‹‹ US SUBOXONE® Film market share eventuality and has implemented effective tax rate. averaged and exited 2018 at 53% certain key elements of its ‹‹ Cash balance at year-end of (2017 avg: 57%; 2017 exit: 56%). contingency plan in light of these $924m (+$61m). Net cash of $681m expected generic launches. ‹‹ Following February 19, 2019 orders (+$305m). Voluntary prepayments from the U.S. District Court for the ‹‹ SUBLOCADE™ net revenues were of $235m on the term loan were District of New Jersey, Dr. Reddy’s $12m. made in the period; $243m remains outstanding. Laboratories (DRL) and Alvogen ‹‹ PERSERIS™ was made available in Pine Brook, Inc. (Alvogen) are no the US in late November 2018. It ‹‹ Indivior implemented key elements longer prevented from selling, launched commercially during the of its contingency plan to help offering to sell, or importing week of February 25, 2019, with a offset the substantial and material their generic buprenorphine/ field force of 50 representatives. near-term impact to net revenue naloxone sublingual film products. that is expected to result from ‹‹ Termination of Arbaclofen Placarbil On February 20, 2019, Indivior the “at-risk” launch of generic and ADDEX lead compound due announced that it had launched versions of SUBOXONE® Film. to challenges in their Phase 1 and an authorized generic version The overriding objectives of the pre-clinical studies, respectively, of SUBOXONE® (buprenorphine contingency plan are to provide reducing their probability of and naloxone) Sublingual Film for the commercial success of success below hurdle rates for (CIII) in the US. It is possible that SUBLOCADE and PERSERIS, while further investment. This decision other generic manufacturers ensuring a minimum cash balance does not change our reason to may also launch generic of $250m to remain in compliance believe in the molecular target versions of SUBOXONE® Film with the Group’s debt covenants. (GABA receptor) and plans are following Indivior’s launch of this B being put in place to accelerate authorized generic. our new lead identification and optimization in partnership with ADDEX.
22 www.indivior.com Strategic report Key actions included: initiatives are supporting greater ROW net revenue decreased 1% ‹‹ reducing outstanding principal on treatment capacity for those in at actual exchange rates (3% at the Term Loan by an additional most need and are likely to be constant exchange rates) to $215m $235m in the year to $243m; manifested in continued growth (2017: $216m). Continued growth in in lower-priced government Australasia and Canada were more ‹‹ cash conservation measures channels, such as Medicaid. than offset by impacts in certain resulting in 2018 ending cash European markets from ongoing balance of $924m; As the leader and innovator in the austerity measures. ‹‹ initiatives to reduce structural OUD category, Indivior has launched operating expenses, including its new monthly buprenorphine Gross margin was 87% (2017: 90%). headcount reductions, R&D depot SUBLOCADE. The decrease versus the prior year reprioritization and other primarily reflects lower net revenue committed savings; and Financial performance driven by higher rebate rates and unfavorable mix and the impact of ‹‹ preparing the launch of Total group net revenue in 2018 contingency planning for the “at-risk” an authorized generic of decreased 8% to $1,005m (2017: launch of a generic buprenorphine/ SUBOXONE® Film upon $1,093m) at actual exchange naloxone sublingual film product. confirmation of the launch of rates (-9% at constant exchange generic buprenorphine/naloxone rates). Volume improvement from Selling, general and administrative sublingual film products. The underlying market expansion in the expenses (SG&A) expenses as launch is expected to capture US and net revenue contribution from reported were $494m (2017: $707m). share of the generic segment SUBLOCADE (2018: $12m) were more These included net exceptional and generate an amount of net than offset by the combined impacts costs of $16m. The exceptional revenue in the range of tens of unfavorable mix from the increase costs comprised $13m related to of US$ millions. in government channels (Medicaid) in the US, targeted rebating to maintain restructuring and $40m related primarily to potential redress for Operating review formulary access and a decline in SUBOXONE® Film market share. ongoing intellectual property related US marketing update litigation, partially offset by a $37m In 2018, market volume for US net revenue decreased 10% to gain from the out-licensing of the buprenorphine products continued $790m (2017: $877m), volume benefits intranasal naloxone opioid overdose to grow at low-teen percentage rates, from underlying market growth were patents. The prior year included in line with Indivior’s expectations. more than offset by the combined exceptional items of $210m for an This volume growth was driven impacts of unfavorable mix from the increased legal provision related to by benefits from legislation and continued disproportionate growth the DOJ investigative and antitrust regulatory changes that have in government channels (Medicaid), litigation matters and the legal increased federal and state funding targeted rebating to maintain settlement of the Amneal antitrust to expand OUD treatment, as well as formulary access and the decline in matter, partially offset by the release from broader general awareness of SUBOXONE® Film market share as a of a legacy litigation reserve. the opioid epidemic. result of competitive pricing pressure from generic buprenorphine/ On an adjusted basis, SG&A expenses Indivior supports the swift actions the naloxone tablet providers. decreased 4% to $478m (Adj. 2017: US government has taken to combat Improved SUBOXONE® Film pricing $497m). The decrease in the year the opioid epidemic, including the was more than offset by tactical largely reflects benefits from cost recent enactment of the SUPPORT rebating activity in connection with savings actions partially offset by the for Patients and Communities Act of formulary access. planned investments for launching 2018, which expands access to BMAT. SUBLOCADE and PERSERIS. These regulatory and legislative
Indivior Annual Report 2018 23 Financial review continued
Reported 2018 R&D expenses were Tax expense was $3m, or a rate Balance Sheet & Cash flow $91m (2017: $89m). The increase was of 1% (2017 tax charge: $79m; 58% Cash and cash equivalents at the end primarily driven by the impairment rate). Tax expenses in the year of the year were $924m, an increase of the Arbaclofen Placarbil and ADDEX included one-time items related to of $61m versus 2017 of $863m. lead compounds in development, development credits for SUBLOCADE Borrowings, net of issuance costs, which have been classified as of $34m, including $1m interest. were $241m at the end of the year exceptional items. Excluding 2017 tax expenses assumed non- (2017: $482m), primarily reflecting the exceptionals, R&D expenses deductibility for tax purposes of impact of the voluntary prepayments decreased by 25% to $67m (Adj. the exceptional legal provisions of $235m of outstanding term loan 2017: $89m). The decrease primarily and included $9m related to the principal in the year. As a result, net reflects lower clinical activity and release of provisions for unresolved cash stood at $681m at year end the reprioritization of R&D activities tax matters, partially offset by the (2017: $376), a $305m improvement primarily to support SUBLOCADE impact of the re-measurement of in the year. Health Economics and Outcomes certain deferred tax assets. Excluding Research (HEOR) and post-marketing exceptional items in 2018 pre-tax Net working capital (inventory study commitments. income and taxation of $46m (2017: plus trade and other receivables, $91m), the adjusted rate was 15% less trade and other payables) Operating profit was $292m (2017: (Adj. 2017: 25%). The decrease in the was negative $356m at year end, $193m). Exceptional costs of $40m adjusted rate was due to changes an increase of $21m from negative and $210m were included in the 2018 in the geographic mix of earnings, $335m since the end of 2017, primarily and 2017 results, respectively. with increased earnings in the UK driven by an increase in sales under the reduced rate for Patent returns and rebates in the US within On an adjusted basis, operating profit Box, along with a reduction in the payables, partially offset by increased was $332m (33% margin), an 18% US corporate income tax rate from inventories due in part to the launch decrease versus $403m (37% margin) 35% to 21%. of SUBLOCADE. in 2017. The decrease reflects lower net revenue, launch investments for Net income was $275m (2017: Cash generated from operations SUBLOCADE and PERSERIS, partly $58m) as reported. Excluding in 2018 was $327m (2017: $369m), a offset by a reduction in operating exceptional costs, 2018 net income decrease of $42m. The reduction in expenses (SG&A and R&D) from was broadly unchanged at $272m cash generated versus the prior year cost savings initiatives. (Adj. 2017: $270m). The current and was primarily due to higher operating prior year included a net amount profit more than offset by a lower EBITDA (operating profit plus of $3m and $212m of exceptional increase in legal provisions versus depreciation and amortization) was items, respectively. the prior year, net of other working $308m (2017: $206m). Excluding $40m capital changes. and $210m of exceptional items in Basic EPS was 38 cents (2017: 8 cents) the current and prior year results, and 37 cents on a diluted basis Net cash inflow from operating respectively, 2018 adjusted EBITDA (2017: 8 cents). On an adjusted basis, activities was $303m (2017: $295m), was $348m (Adj. 2017: $416m). excluding the effect of exceptional an increase of $8m reflecting lower items, 2018 basic EPS was 37 cents cash from operations more than Net finance expense was $14m (2017: 37 cents) and diluted EPS was offset by lower net interest payments (2017: $56m). The reduction in each 36 cents (2017: 36 cents). of $8m vs. $36m in the prior year period reflects lower interest and and reduced tax payments of $16m amortization of financing costs vs. $33m in 2017. associated with the replacement of the Group’s term loan borrowing facility in December 2017 and the voluntary repayments of $235m of the principal balance in the year, and higher interest income.
24 www.indivior.com Strategic report Cash outflow from investing activities Adjusted Results was $4m (2017: $43m), reflecting The Board of Directors, and Executive upfront payments for licensing Committee use adjusted results and arrangements with ADDEX and C4X, measures to give greater insight to capitalized development costs, and the financial results of the Group and ongoing investments in facilities, the way it is managed. They believe mostly offset by proceeds received the use of the adjusted measures from the disposal of the nasal such as adjusted operating profit, naloxone intangible asset. adjusted net income and adjusted earnings per share provide additional Cash outflow from financing activities useful information on underlying increased to $237m vs. $84m in 2017, trends to shareholders. The tables primarily reflecting the impact of the below show the list of adjustments voluntary prepayments of $235m of between the reported and adjusted the outstanding Term Loan balance in operating profit, net income, and the year. earnings per share for both 2018 and 2017. Further details of each adjustment is available in Note 5 of the notes to the Group’s financial statements on page 105.
Reconciliation of operating profit to adjusted operating profit
2018 2017 $m $m Operating profit 292 193 Exceptional selling, general and administrative expenses 16 210 Exceptional research and development expenses 24 – Adjusted operating profit 332 403
Reconciliation of net income to adjusted net income
2018 2017 $m $m Net Income 275 58 Exceptional selling, general and administrative expenses 16 210 Exceptional research and development expenses 24 – Exceptional financing costs – 14 Exceptional tax items (43) (12) Adjusted net income 272 270
Reconciliation of earnings per share to adjusted earnings per share
2018 2017 cents cents Earnings per share 38 8 Exceptional selling, general and administrative expenses 2 29 Exceptional research and development expenses 3 – Exceptional financing costs – 2 Exceptional tax items (6) (2) Adjusted earnings per share 37 37 Weighted average number of shares (thousands) 727,148 721,126
Indivior Annual Report 2018 25 Legal proceedings
Litigation/Investigative matters interactions with a non-profit third- and Amneal has dismissed its claims The Group carries a provision for party organization. On November against the Group with prejudice. The investigative and antitrust litigation 16, 2016, Indivior was served with a other antitrust cases are pending in matters of $438m. Substantially subpoena for records from the State federal court in the Eastern District of all of the provision relates to the of California Department of Insurance Pennsylvania. Pre-trial proceedings U.S. Department of Justice (DOJ) under its civil California insurance were coordinated. The fact discovery investigation. The Group is in code authority. The subpoena period has closed; expert discovery advanced discussions with the DOJ requests documents related to and briefing on class certification about a possible resolution to its SUBOXONE® Film, SUBOXONE® issues is ongoing. investigations, although it cannot Tablet, and SUBUTEX Tablet. predict with any certainty whether, The State has served additional Estate of John Bradley Allen when, or at what cost it will reach an deposition subpoenas on Indivior in On December 27, 2016, the Estate ultimate resolution. 2017 and served a subpoena in 2018 of John Bradley Allen filed a civil requesting documents relating to complaint against Indivior, among U.S. Department of the bioavailability/bioequivalency other parties, in the Northern District Justice Investigation of SUBOXONE® Film, manufacturing of New York seeking relief under records for the product and its A US federal criminal grand jury Connecticut’s products liability components, and the potential to investigation of Indivior initiated in and unfair trade practices statutes develop dependency on SUBOXONE® December 2013 is continuing, and for damages allegedly caused Film. The Group is fully cooperating includes marketing and promotion by SUBOXONE®. This lawsuit was in these civil investigations. practices, pediatric safety claims, and dismissed without prejudice on over prescribing of medication by August 9, 2018. FTC investigation and certain physicians. The US Attorney’s Office for the Western District of Antitrust Litigation Opioid Class Action Litigation Virginia has served a number of The US Federal Trade Commission’s In February 2019, Indivior PLC, subpoenas relating to SUBOXONE® investigation remains pending. along with other manufacturers of Film, SUBOXONE® Tablet, SUBUTEX® Litigation regarding privilege claims opioid products, was named in the Tablet, buprenorphine and our has now been resolved. Indivior has national civil opioid class action competitors, among other issues. produced certain documents that it litigation brought by state and local The Group has responded to the had previously withheld as privileged; governments, alleging misleading subpoenas and has otherwise other such documents have not marketing messages. This complaint cooperated fully with the Department been produced. was filed by several Kentucky public and prosecutors and will continue health agencies in the class action to do so. The Group is in advanced Civil antitrust claims have been consolidated in the federal district discussions with the Department of filed by (a) a putative class of court for the Northern District of Ohio Justice about a possible resolution direct purchasers, (b) a putative on February 6, 2019. On February to its investigation. However, it is class of end payor purchasers, 21, 2019, Indivior was voluntarily not possible to predict with any (c) Amneal Pharmaceuticals LLC dismissed with prejudice from certainty the potential impact of (Amneal), a manufacturer of generic the lawsuit. this investigation on the Group or buprenorphine/naloxone tablets, and to quantify the ultimate cost of (d) a group of states, now numbering a resolution. 41, and the District of Columbia. Each set of plaintiffs filed generally State Subpoenas similar claims alleging, among other things, that Indivior violated On October 12, 2016, Indivior was US federal and/or state antitrust served with a subpoena for records and consumer protection laws in from the State of Connecticut attempting to delay generic entry of Office of the Attorney General alternatives to SUBOXONE® tablets. under its Connecticut civil false Plaintiffs further allege that Indivior claims act authority. The subpoena unlawfully acted to lower the market requests documents related to the share of these products. The Group Group’s marketing and promotion has settled the dispute with Amneal, of SUBOXONE® products and its
26 www.indivior.com Strategic report Intellectual property TRO, preventing DRL from continuing its forthcoming petition for certiorari related matters to sell or offer to sell its generic seeking to overturn the CAFC’s PI ANDA Litigation product. Indivior was required to vacatur. On February 19, 2019, the post an $18 million surety bond to Supreme Court of the United States Actavis is currently enjoined from cover DRL’s damages in the event denied Indivior’s motion to stay launching a generic buprenorphine/ of an Indivior loss of its patent case issuance of the CAFC’s mandate naloxone film product until April against DRL. On June 28, 2018, the vacating the PI granted against DRL. 2024 based on a June 3, 2016 ruling court heard oral argument in support The CAFC subsequently issued the by the United States District Court of Indivior’s motion for a PI against mandate vacating the PI granted for the District of Delaware finding DRL and, at the conclusion of this against DRL. The U.S. District Court the asserted claims of the ’514 hearing, extended the TRO for an for the District of New Jersey then Patent valid and infringed. Actavis additional 14 days in order to rule on confirmed the PI against DRL had has appealed this ruling. On October the PI motion and required Indivior to been vacated. 24, 2017, Actavis received tentative post another $18 million surety bond. approval from FDA for at least its On July 13, 2018, the District Court DRL is therefore are no longer 8mg/2mg generic product under its issued its ruling granting Indivior a prevented from selling, offering Abbreviated New Drug Application PI against DRL. On July 18, 2018, the to sell, or importing their generic (ANDA) No. 204383 and on November District Court ordered Indivior to buprenorphine/naloxone sublingual 15, 2017, it received tentative approval post a surety bond for $72 million film products. DRL has re-launched for its 12mg/3mg generic product (that total figure being inclusive of its generic product, and any sales under ANDA No. 207087. Litigation the $36 million surety bond already in the U.S. are on an “at-risk” basis, against Actavis is also pending in posted) in connection with the PI. subject to the outcome of the CAFC the District of Delaware on Indivior’s DRL appealed to the United States appeal of the judgments related to more recently listed Orange Book Court of Appeals for the Federal U.S. Patent No. 8,603,514, (and U.S. Patents: US Patent Nos. 9,687,454 Circuit (CAFC) on the same day. On 8,017,150 in the case of DRL), as well (the ‘454 Patent), and 9,931,305 November 20, 2018, the CAFC issued as ongoing litigation in the District of (the ‘305 Patent). a decision vacating the PI against New Jersey asserting Orange Book- DRL. Indivior filed a timely petition listed U.S. Patent Nos. 9,931,305 and On August 31, 2017, the United for rehearing and rehearing en banc 9,687,454. States District Court for the District on December 20, 2018. The CAFC of Delaware found that asserted denied the petition on February 4, On February 12, 2019, the CAFC claims of US Patent No. 8,017,150 2019. On February 5, 2019, Indivior granted Indivior’s request to (the ’150 Patent), US Patent No. filed an emergency motion to stay expedite the appeal of the non- 8,900,497 (the ’497 Patent), and the the issuance of mandate pending infringement judgment in the ‘514 ’514 Patent are valid but not infringed the resolution of the appeal of the patent case to the extent it will be by DRL. Indivior has appealed this District of Delaware decision with placed on the next available oral ruling. Litigation against DRL is respect to the ‘514 patent, and argument calendar. currently pending in the District pending Indivior’s forthcoming of New Jersey on the ‘454 and ‘305 petition for a writ of certiorari to the On November 13, 2018, DRL filed patents. DRL received final FDA Supreme Court of the United States two separate petitions for inter approval for all four strengths in the PI matter. The CAFC denied partes review of the ‘454 Patent with of its generic buprenorphine/ that motion on February 11, 2019, and the USPTO. Indivior’s preliminary naloxone film product on June 14, Indivior filed a second emergency responses are due March 6, 2019 and 2018, and immediately launched its motion to stay the mandate pending March 7, 2019. generic buprenorphine/naloxone resolution of its forthcoming film product “at-risk.” On June 15, application for an administrative stay Teva filed a 505(b)(2) New Drug 2018, Indivior filed a motion with to the Supreme Court of the United Application (NDA) for a 16mg/4mg the United States District Court for States. The CAFC denied that motion strength of buprenorphine/naloxone the District of New Jersey seeking a and ordered issuance of the mandate film (CASSIPA™). Indivior, Aquestive Temporary Restraining Order (TRO) on February 19, 2019. Indivior filed an Pharmaceuticals (formerly known as and Preliminary Injunction (PI) application to the Supreme Court of MonoSol Rx) and Teva agreed that pending the outcome of a trial on the United States requesting a stay infringement by Teva’s 16mg/4mg the merits of the ’305 Patent. The of the mandate pending resolution of dosage strength would be governed court granted Indivior a two-week by the infringement ruling as to
Indivior Annual Report 2018 27 Legal proceedings continued
Dr. Reddy’s 8mg/2mg dosage strength Alvogen is enjoined from the use, Rhodes Pharmaceuticals that was the subject of the trial in offer to sell, or sale within the United November 2016. Accordingly, the non- Sates, or importation into the United On December 23, 2016, Rhodes infringement ruling in the Dr. Reddy’s States, of its generic buprenorphine Pharmaceuticals filed a complaint case means that the Teva 16mg/4mg and naloxone sublingual film product against Indivior in the United States dosage strength has been found not unless and until the CAFC issues a District Court for the District of to infringe. Indivior has appealed this mandate vacating the PI against DRL. Delaware, alleging that Indivior’s November 2016 ruling. Litigation is Alvogen has launched its generic sale of SUBOXONE® Film in the US ongoing against Teva in the District product, and any sales in the US are infringes one or more claims of US of New Jersey on the ‘454 patent on an “at-risk” basis, subject to the Patent No. 9,370,512 (the ‘512 Patent). and ‘305 patent. Teva received final outcome of the appeal of the non- The asserted patent, which was approval from the FDA for CASSIPA on infringement judgment related the issued in June 2016, claims priority to September 7, 2018, and has agreed ‘514 patent, as well as the ongoing an application filed in August 2007. to be bound by the decision in the litigation against Alvogen in the DRL PI case. Now that the mandate District of New Jersey. On February On March 16, 2018, Indivior filed a has issued in the DRL PI case, Teva is 12, 2019, the CAFC granted Indivior’s petition for inter partes review (IPR) no longer prevented from launching request to expedite the appeal of the with the United States Patent and CASSIPA. Any sales of CASSIPA in the non-infringement judgment in the Trademark Office (USPTO) asserting US would be on an “at-risk” basis, ‘514 patent case to the extent it will that all claims of the ‘512 Patent subject to the outcome of the appeal be placed on the next available oral are invalid. of the non-infringement judgment argument calendar. related to the ‘514 patent, as well as On October 4, 2018, the USPTO the ongoing litigation against Teva By a Court order dated August 22, declined to institute an IPR on the and DRL in the District of New Jersey. 2016, Indivior’s SUBOXONE® Film challenged claims of the ’512 patent. patent litigation against Sandoz Trial against Alvogen in the lawsuit was dismissed without prejudice involving the ’514 and ’497 Patents because Sandoz is no longer pursuing for SUBOXONE® Film took place Paragraph IV certifications for its in September 2017. The trial was proposed generic formulations of limited to the issue of infringement SUBOXONE® Film. because Alvogen did not challenge the validity of either patent. On March On September 25, 2017, Indivior 22, 2018, the United States District settled its SUBOXONE® Film patent Court for the District of Delaware litigation against Mylan, the terms issued its ruling finding both patents of which are confidential. Mylan not infringed by Alvogen. Indivior received final FDA approval for has appealed this ruling. Litigation its generic version of the 8mg against Alvogen is also pending in buprenorphine/naloxone film the United States District Court for product on June 14, 2018. the District of New Jersey on the ‘454 Patent and the ‘305 Patent. On May 11, 2018, Indivior settled its On January 22, 2019, Indivior filed a SUBOXONE® Film patent litigation motion for a temporary restraining against Par. Under the terms of the order (“TRO”) and preliminary settlement agreement, Par can launch injunction in the District of New its generic buprenorphine/naloxone Jersey, requesting that the Court film product on January 1, 2023, or restrain the launch of Alvogen’s earlier under certain circumstances. generic buprenorphine/naloxone Other terms of the settlement film product until a trial on the merits agreement are confidential. So far as of the ‘305 patent. Alvogen received Indivior is aware, FDA to date has not approval for its generic product granted tentative or final approval on January 24, 2019. The same day, for Par’s generic buprenorphine/ the District of New Jersey granted a naloxone film product. TRO until February 7, 2019, with a PI hearing scheduled for that day. On January 31, 2019, Indivior and Alvogen entered into an agreement whereby
28 www.indivior.com Risk management Strategic report How Indivior reviews and manages its risk
Board of Executive Directors Committee
Business Unit and Internal Corporate Functional Audit Leadership Team
Risk Mitigation
Information Integrity and Technology (IT) Compliance Department Department
Risk Business Continuity Management Committee Team
Our Board of Directors Our Integrity and Our Information determines the Group’s risk appetite, Compliance Department Technology (IT) Department carries out a robust assessment develops and implements develops and maintains processes of the Group’s emerging risks and an effective compliance and controls to protect Indivior’s provides governance of Indivior’s management program electronic data and assets principal risks Our Risk Management Team Our Business Unit and Our Executive Committee coordinates the risk Corporate Functional leadership monitors and reviews the management program executes day-to-day risk principal risks. Oversees the management activities and manages risk management program Our Business risk mitigation actions within their Continuity Committee respective functions or areas Our Internal Audit Team reviews and monitors business provides independent assurance continuity activities of the effectiveness of governance, risks and controls
Indivior Annual Report 2018 29 Risk management continued
Principal risks and risk management
The Board of Directors has carried out Risk management The Executive Committee establishes a robust assessment to ensure that To maintain our position as the the risk agenda for the reporting the principal risks, including those leading pharmaceutical company and ongoing management of risks that would threaten the Group’s focused primarily on the treatment and for the stewardship of the business model, future performance, of addiction, we recognize that we risk management approach. The solvency or liquidity, are effectively must understand the risks we face; Executive Committee assesses, on a managed and/or mitigated to help those inherent in our strategy and quarterly basis, changes to the key ensure the Group remains viable. operations, and those presented risks impacting the Group, including While the Group aims to identify by external conditions. We take a new and emerging risks and impacts and manage such risks, no risk systematic and robust approach to Indivior’s principal risks. management strategy can provide to identify and monitor those absolute assurance against loss. risks and continuously adjust our Risk control assurance processes, controls and monitoring The Directors have overall The table overleaf provides insight activities accordingly. responsibility for the Group’s into the principal risks, outlining why risk management framework. effective management of these risks Our approach The Directors review the Group’s is important, how we manage them, Our systematic risk management principal risks and emerging risks how the risks relate to the Group’s approach is designed to identify with a focus on key risk areas. The strategic priorities, and which risks risks that would threaten the Group’s Board’s Committees regularly review are rising, falling or have remained business model, future performance, risks relevant to their area of focus; static during the past 12 months. solvency or liquidity. Effective risk this includes, but is not limited to, Additional risks, not listed here, that management is fundamental to risks relating to legal, financial and the Group cannot presently predict our ability to meet our operational compliance matters. Assurance on or does not believe to be equally and strategic objectives. The governance, risks and controls is significant, may also materially competitive market in which we provided by internal management and adversely affect the Group’s operate has industry-specific risks, information, internal audits, external revenues, financial condition and particularly those relating to new audits and Board oversight. There is results of operations. The principal product development, intellectual also an externally supported web- risks and uncertainties are not listed property enforcement and legal based and confidential employee in order of significance. proceedings, and compliance with reporting system in place (EthicsLine). laws and regulations. This requires that business risks are effectively In addition to the principal risks assessed, appropriately measured discussed below, the Group is and addressed through mitigation facing heightened viability risks plans. Our overall risk management that could have an impact on the approach is to foster and embed Group’s ability to achieve its near- a culture of risk management that term financial forecasts (refer to is responsive, forward-looking, our viability statement on page 35). consistent and accountable. Those risks are being closely and actively monitored by the Board and management.
30 www.indivior.com Strategic report Business operations The Group’s operations rely on complex processes and systems, strategic partnerships, as well as specially-qualified and high-performing personnel to develop, manufacture and sell our products. Failure to continuously maintain operational processes and systems as well as to recruit and/or retain qualified personnel could adversely impact products’ availability and patient health, and ultimately the Group’s operational financial performance. Additionally, an ever-evolving regulatory, political and technological landscape requires that we have the right priorities, capabilities and structures in place to execute successfully on our business strategy and adapt to this changing environment. An example of this evolving landscape is Brexit (decision for the UK to leave the EU), which creates uncertainties and impacts various areas of the Group, including Operations, Regulatory, Supply Chain, and Quality.
Change from 2017 Increased operational challenges due to Brexit disruptions and staff reductions linked to the optimization of the base business Link to strategic priorities Building the resilience of our franchise and expanding global treatment
Examples of risks: Management actions ‹‹ Failure to retain and recruit qualified ‹‹ Talent management programs are in place, including talent review and workforce and key talent retention programs, with focus on identifying key roles and successors ‹‹ Process disruptions due to staff ‹‹ Programs to reinforce the culture, centered around passion and reductions commitment to support the patient journey, are in place ‹‹ Failure of information technology ‹‹ Knowledge transfer and transition plans are being developed (IT) systems, including from cyber ‹‹ IT policies, processes, systems and disaster recovery plans supporting security incidents (e.g. Malware overall business continuity are in place and Ransomware), and data ‹‹ Strategy and processes to secure systems and protect data are in place privacy breach ‹‹ Business standards, product quality, patient safety related policies and ‹‹ Disruptions in our operations due training are in place to Brexit ‹‹ A Brexit steering committee monitors the evolving impact of Brexit and facilitates appropriate business planning
Product pipeline, regulatory and safety The development and approval of the Group’s products is an inherently risky and lengthy process requiring significant financial, research and development resources, and strategic partnerships. Complex regulations with strict and high safety standards govern the development, manufacturing and distribution of our products. In addition, strong competition exists for strategic collaboration, licensing arrangements and acquisition targets. Patient safety depends on our ability to perform robust safety assessment and interpretation to ensure that appropriate decisions are made regarding the benefit/risk profiles of our products. Deviations from these quality and safety practices can impact patient safety and market access, which can have a material effect on the Group’s performance and prospects.
Change from 2017 No change Link to strategic priorities Developing our innovative pipeline, building the resilience of our franchise and expanding global treatment
Examples of risks: Management actions ‹‹ Failure to advance the development, ‹‹ Product development, business development and international growth and/or obtain regulatory approval, strategies are in place of pipeline products ‹‹ Due diligence, market valuation, and economic and financial modeling ‹‹ Failure to achieve expected market are in place acceptance ‹‹ Ongoing monitoring of CROs’ performance and clinical practices is ‹‹ Performance failure of our Clinical in place Research Organization (CRO) ‹‹ Ongoing Quality and Safety monitoring and auditing programs are in place partners ‹‹ Strategies to defend against and pursue appropriate resolution of ‹‹ Potential liability and/or additional product liability claims are in place expenses associated with ongoing ‹‹ Rigorous pharmacovigilance processes for ongoing evaluation of data regulatory obligations and oversight collected from multiple sources related to patient safety are in place, ‹‹ Unexpected changes to the benefit/ including Risk Evaluation and Mitigation Strategy (REMS) programs in risk profiles of our products the US and Risk Management Plans (RMP) outside the US.
Indivior Annual Report 2018 31 Risk management continued
Commercialization Successful commercialization of our products is a critical factor for the Group’s sustained growth and robust financial position. Launch of new product involves substantial investment in marketing, market access and sales activities, product stocks, and other investments. Generic and brand competition, pricing pressures, private and government reimbursement schemes and systems, negotiations with payors, erosion and/or infringement of intellectual property (IP) rights, political and socioeconomic factors and HCP/patient adoption and adherence, if different than anticipated, can significantly impact the Group’s performance and position.
Change from 2017 Increased generic competition/threats and performance of SUBLOCADE™ in 2018 (Refer to the Chief Executive Officer’s statement on pages 12 to 15 or the Finance Review section on pages 22 to 25) Link to strategic priorities Building the resilience of our franchise, expanding global treatment, and developing and fortifying the business
Examples of risks: Management actions ‹‹ Unexpected changes to government ‹‹ Including health economic factors in the development of new products and/or commercial reimbursement ‹‹ Managing prices within acceptable ranges levels and pricing pressures ‹‹ Enhanced investments to educate and facilitate patients’ access and ‹‹ Slower than expected ramp up and reimbursement working with key stakeholders adoption of the new SUBLOCADE™ ‹‹ Emphasizing value of products and health economics tailored to distribution platform and payor commercial and government payors through market access activities approval process impacting HCP and patient adoption ‹‹ Patient platforms supporting provider location, reimbursement support, and co-pay assistance for non-government patients are in place ‹‹ Launch or marketing of competing branded and generic products ‹‹ Ongoing training and development for field-based employees are in place ‹‹ HCP and patient adoption of the new treatment paradigm for ‹‹ Active monitoring of “at risk” generic launches and activation of related SUBLOCADE™ and PERSERIS™ contingency plans ‹‹ International growth, pipeline development, and business development strategies are in place
Economic and financial The nature of the pharmaceutical business is inherently risky and uncertain, and requires that we make significant financial investments to develop and support the success of our product portfolio. External financing is a key factor in sustaining our financial position and expanding our business growth. Our ability to realize value on those investments is often dependent on regulatory approvals, market acceptance, strategic partnerships, competition and legal developments. As a global business, we are also subject to political, economic and capital markets changes. External financing is a key factor in sustaining our financial position and expanding our business growth.
Change from 2017 Financial pressure due to increased generic competition and performance of SUBLOCADE™ (Refer to the Finance Review section on pages 22 to 25) Link to strategic priorities Developing our innovative pipeline, building the resilience of our franchise, expanding global treatment, and developing and fortifying the business
Examples of risks: Management actions ‹‹ Concentration of revenues ‹‹ Strategies supporting expansion opportunities and diversification geographically and/or by product are in place ‹‹ Inability to raise capital or execute ‹‹ Regular appraisals of debt and capital market conditions with advisors product and business developments and counterparties are in place and alliance opportunities ‹‹ Realignment of cost and finance structures, and active expense ‹‹ Failure to meet financial obligations management are in place and performance ‹‹ Ongoing monitoring of financial performance and compliance with ‹‹ Inability to identify and realize financial covenants potential business development ‹‹ Internal and external resources in place to identify potential targets opportunities and ensure rigorous due diligence of acquisitions and/or new product initiatives
32 www.indivior.com Strategic report Supply chain The manufacturing and supply of our products are highly complex and rely on a combination of internal manufacturing capabilities and third parties for the timely supply of our finished drug and combination drug products. The Group has a single source of supply for buprenorphine, an active product ingredient (API) in the Group’s products, and uses contract manufacturing organizations (CMOs) to manufacture, package and distribute our products. The manufacturing of non-sterile pharmaceutical and sterile filled pharma/combination drug products is subject to stringent global regulatory quality and safety standards, including Good Manufacturing Practice (GMP). Delays or interruptions our supply chain, and/or product quality failures could significantly disrupt patient access, adversely impact the Group’s financial performance; lead to product recalls, and/or potential regulatory actions against the Group, along with reputational damage.
Change from 2017 No change Link to strategic priorities Building the resilience of our franchise, and expanding global treatment
Examples of risks: Management actions ‹‹ Inability to supply compliant ‹‹ Business continuity, disaster recovery, and emergency response plans finished products in a continuous across the supply chain network are in place and timely manner ‹‹ Contingency plans and management of safety stocks are in place ‹‹ Single source of API and reliance on ‹‹ Comprehensive product quality and control processes and manufacturing critical CMOs performance monitoring across the supply chain network are in place ‹‹ Ongoing monitoring of stock levels and implementation of insurance coverage
Legal and intellectual property Our pharmaceutical operations, which include controlled substances, are subject to a wide range of laws and regulations from various governmental and non-governmental bodies. Perceived noncompliance with these applicable laws and regulations may result in investigations or proceedings leading the Group to become subject to civil or criminal sanctions and/or pay fines and/or damages, as well as reputational damage.
Intellectual Property (IP) rights protecting our products may be challenged by external parties, including generic manufacturers. Although we have developed robust patent protection for our products, we are exposed to the risk that courts may decide that our IP rights are invalid and/or that third parties do not infringe our asserted IP rights.
Unfavorable outcome from government investigations and/or resolutions from legal proceedings, expiry and/or loss of IP rights could have a material adverse impact on the Group’s prospects, results of operations and financial condition.
As previously disclosed in the Prospectus dated November 17, 2014, Indivior has indemnification obligations in favor of Reckitt Benckiser (RB) (page 43). Some of these indemnities are unlimited in terms of amount and duration and amounts potentially payable by the Indivior Group pursuant to such indemnity obligations could be significant and could have a material adverse effect on the Indivior Group’s business, financial condition and/or operating results. Requests for indemnification may be subject to legal challenge.
Indivior Annual Report 2018 33 Risk management continued
Change from 2017 Material business impact of “at-risk” generic launches (Refer to the Legal proceedings section on pages 26 to 28 and Chair and Chief Executive Officer statements on pages 4 to 5 and 12 to 15 respectively) Link to strategic priorities Building the resilience of our franchise
Examples of risks: Management actions ‹‹ Legal proceedings related to ‹‹ Quality, patient safety, monitoring and compliance are embedded in product liability claims, antitrust, the Group’s processes and culture government enforcement and/or ‹‹ Cooperation with government authorities in connection with ongoing private litigation associated with investigations, utilizing internal and external counsel the manufacturing, marketing and ‹‹ Insurance coverage and monitoring of legal proceedings are in place distribution of our products ‹‹ Ongoing active review, management and enforcement of our product ‹‹ Government investigations of the patents, marketing exclusivity and other IP rights are in place Group’s business activities ‹‹ Strategies to defend against infringement claims and pursue ‹‹ Infringement of IP rights of enforcement of product patents and other IP rights are in place third-parties ‹‹ Geographic expansion and product diversification strategies are ‹‹ Inability to obtain, maintain in place and protect patents and other proprietary rights
Compliance Our Group operates on a global basis and the pharmaceutical industry is both highly competitive and regulated. Complying with all applicable laws and regulations, including engaging in commercial activities that are consistent with legal and industry standards, and our Group’s Code of Conduct are core to the Group’s mission, culture and practices. Failure to comply with applicable laws and regulations may subject the Group to civil, criminal and administrative liability, including the imposition of substantial monetary penalties, fines, damages and restructuring the Group’s operations through the imposition of compliance or integrity obligations, and have a potential adverse impact on the Group’s prospects, reputation, results of operations and financial condition.
Change from 2017 No change Link to strategic priorities Building the resilience of our franchise, and expanding global treatment
Examples of risks: Management actions ‹‹ Failure to act in an ethical manner ‹‹ Ongoing evolution of our compliance program and compliance aligned with our Code of Conduct capabilities in place ‹‹ Non-compliance with ‹‹ All employees are required to perform annual training and certify anti-corruption, healthcare, data compliance with our Code of Conduct privacy, or local laws and regulations ‹‹ Compliance policies and processes, and related mandatory employee ‹‹ Failure to comply with payment and training programs are in place reporting obligations under the US ‹‹ Confidential independent reporting process for employees to report and foreign government programs concerns is in place ‹‹ Inability to respond adequately to ‹‹ Increased oversight and monitoring of controls and procedures in changes in laws and regulations emerging markets are in place ‹‹ Government investigations of the ‹‹ Ongoing monitoring of controls over government pricing and reporting Group’s business activities in place ‹‹ Compliance risk assessment and monitoring of key risks are in place ‹‹ Continuous review and assessment of developments in the law, applicable industry standards, and business practices ‹‹ Cooperating with the authorities on ongoing investigations, using external counsel
34 www.indivior.com Viability statement Strategic report The Group’s viability is dependent and approves the budget for the and address the reasonably possible upon execution of our business upcoming year as well as the long- financial implications of legal strategy, with a focus on: term strategic plan, which includes proceeding risks. challenging key assumptions and risk ‹‹ expansion of HCP and patient mitigation plans included therein. Other risks identified in the adoption of SUBLOCADE™; principal risks table on pages 31 to ‹‹ the US launch of PERSERIS™; In accordance with the UK Corporate 34 were also considered, but the Governance Code, the Directors above financial risks and operating ‹‹ optimization of the base business; have assessed the viability of the considerations were considered and Group. In determining a time period the most immediate and significant ‹‹ management of our risk related to to assess the viability of the Group, that could prevent the Group from legal proceedings and response the Directors considered the Group’s delivering on its strategy. A number strategy. strategic plan, business cycle, of other aspects of the principal risks potential impacts of new product – because of their nature or potential The Board has evaluated the Group’s launches, generic challenges, ongoing impact – could also threaten the risk profile through the lens of the legal proceedings, cost reduction Group’s viability in its current form, if challenges faced in 2018, including actions and liquidity. Considering the they were to occur. the material uncertainty that may newly launched portfolio products cast significant doubt on the Group’s and the term loan expiration date, The results of this stress testing ability to continue as a going the Directors believe a period to showed the Group would be able concern, as discussed in Note 2 to 2022 factors in the risks in these to withstand the impact of these the Financial Statements. Further, the activities. This assessment period scenarios occurring over the period elevated risk resulting from slower provides a reasonable basis for the of the viability assessment. The than expected SUBLOCADE adoption financial impact of these significant Group will be required to use its in addition to the loss of SUBOXONE® developments to be fully considered. cash reserves and may need to Film exclusivity in the US have Accordingly, a four-year period of make further cuts to its operating exposed the Group to heightened assessment is deemed appropriate. costs and planned strategic viability risks. Considering these risks, investments. Depending upon the structural changes have been made, Although the strategic plan reflects ultimate realization under the including significant early retirement the Directors’ best estimate of the different scenarios, the actions that of debt and cost reduction actions, future prospects of the business, management would need to take as the Group streamlines its focus on they have also “stress tested” the will vary to ensure ongoing viability the two newly-approved products. plan under various scenarios. The of the Group. Once these are established, Indivior scenarios, which encompass a wide will once again seek to expand with spectrum of potential outcomes, Possible scenarios may occur where new treatments in the addiction and reflect the impact from the loss of the uptake of both SUBLOCADE and behavioral health disease spaces. exclusivity for SUBOXONE® in the US, PERSERIS falls significantly below and contemplate limited uptake of expectations and the outcome of legal The prospects of the Group are PERSERIS in the US, are designed to proceedings or timing of payments for evaluated throughout the year explore the resilience of the Group legal proceedings is materially worse as part of the strategic planning to the potential impact of significant than planned, in which circumstances process. This process is led by the risks set out on pages 30 to 34. These the Group’s viability may be impacted Chief Executive Officer through the scenarios represent ‘severe but during the assessment period. In the Executive Committee and involves plausible’ circumstances the Group early portion of the viability period, all relevant functions such as could experience. The scenarios the Directors’ control over certain R&D, supply, commercial, medical, tested included: matters, such as legal proceeding legal, compliance and finance. response strategy, helps to mitigate Development of the strategic ‹‹ underperformance in the expected risk to the Group’s viability. However, plan includes a deep dive into the market acceptance of SUBLOCADE over the full viability period, the principal risks and contemplated over the viability period, and Directors’ ability to influence the actions to manage and mitigate ‹‹ unfavorable outcome of legal outcome of such matters may be those risks. proceedings. more limited.
The output of the strategic plan is a Having considered these risk factors Based on their assessment of set of objectives, an analysis of key along with other principal risks set prospects and viability above, the risks that could prevent the plan out on pages 30 to 34, the Directors Directors confirm their reasonable being delivered, and a financial have assessed the Group’s ability to expectation that the Group will forecast covering the following comply with the financial covenant continue in operation and meet its year. Within the Group’s extended in the Group’s debt facility, maintain liabilities as they fall due over the four- strategic horizon, financial forecasts sufficient liquidity to fund its year period ending December 31, 2022. are also prepared. The Board reviews operations, pay off the debt in 2022, Indivior Annual Report 2018 35 Chair’s governance statement
Strong and robust corporate governance delivering accountability
“Good governance is an essential part of our ethos underpinning the delivery of our vision for the benefit of colleagues, shareholders and stakeholders.”
Howard Pien Chair of the Board
Dear Shareholder, Culture and governance On behalf of the Board, I am The Indivior Guiding Principles pleased to present the Corporate (the values we respect) and our Governance Report for the year Code of Conduct (the behaviors we ended December 31, 2018. As Chair of expect) underpin everything that we the Board, my role is to manage the do and the type of organization we Board and to ensure that it operates want to be. Everyone who works for effectively. This year has seen and with us is required to comply continued focus on the Group’s with these. The Board, Executive corporate governance arrangements, Committee and our management ensuring that we have strong and understand that how we work is as robust corporate governance at the important as what we achieve. Our heart of everything we do. culture and values are not only The Board continues to adhere to championed by the Board and the the principles of integrity, respect, Executive Committee but permeate transparency and openness. Board throughout our organization. members are expected to lead by Activities during the year example and exemplify the highest During 2018, the Board formally met standards of propriety, diligence on five occasions and held a further and accountability. 17 ad hoc meetings, which were primarily held by conference telephone. The ad hoc meetings dealt with matters covering the ongoing DOJ investigation, antitrust litigation matters, litigation regarding Orange Book-listed patents and the possibility of a
36 www.indivior.com Governance 37 37 37 Indivior Annual Report 2018 Looking ahead standards the highest Maintaining integral is governance corporate of to the delivery of our vision. Your remainsBoard focused ensuring on stakeholders and shareholders our will benefitfrom the strong which is present ethos governance throughout the Group. Pien Howard ofChairBoardthe March 1, 2019 by the Financial Reporting Council (the ‘Code’), sets sets ‘Code’), (the Council Reporting Financial the by ally in the EMEA EMEA the in ally 2018 and will apply for the financial year ending year for the financial ending 2018 and will apply anges to prepare for compliance with the new Code. Code. new the with compliance for prepare to anges As the UK Government continues continues Government UK the As uncertainty negotiations, Brexit its remainsas to the extent towhich the affectedin be businesswill our longerterm. To prepare for all eventualities, we formed a Brexit met which Committee Steering regularly throughout the year and has led the Group in preparing to satisfy the new regulatory especi environment, region, and to mitigate any risk. set is Brexit to reference Further onout page 31. Board effectiveness of cycle annual of its As part the undertook Board business, an evaluation to consider the performanceof the Board, each Directors,the of andBoard’s the The committees. principal report was prepared by Lintstock and detailed several areas for consideration, as outlined on page 48. The Board will and committees areas on these attention focus duringthe coming year. The overall performanceBoardthe andof its rated, positively was committees especially given the challenges facingthe business. December 31, 2019. The Board has undertaken an assessment of its readiness to comply with and report against against report and with comply to readiness its of assessment an undertaken has Board The 2019. 31, December ch certain adopt to begun we have and Code, 2018 the out standards of good practice in relation to Board leadership and effectiveness, remuneration, accountability accountability remuneration, and effectiveness, leadership Board to relation in good practice of standards out shareholders. with relations and Throughout the Code. of Principles Main the applied has Board the how describes to 82 42 on pages report The Code. the of provisions the with complied has Company the report, this of date the to and year financial the ofcopy CodeA the isavailable website from FRC the www.frc.org.uk. in waspublished Code Governance UK new Corporate A UK Code Corporate Governance 2016 April in The published Code, UK Corporate Governance
launch of a generic buprenorphine/ launch generic a buprenorphine/ of product. film naloxone governance strengthen further To business, the within oversight and we made two strategic appointments during the year. The Internal Audit andRisk Management functions Vice a and new combined were Audit Internal of Head President, and Risk Management was the created also We appointed. newroleChiefof Integrity and is an which Officer, Compliance role. Committee Executive subsidiary our of strengthening The of area another was governance focusduring year.Ledthe the by Company Secretary, further process including enhancements and monitoring initiatives were also We Group-wide. introduced provider, service a new appointed Eversheds Sutherland (International) ongoing the with assist to LLP, requirements for administrative manyof the Group’s overseas subsidiary companies, and training a bespoke developed programfor subsidiary directors, whichincluded a focus subsidiaryon duties. directors’ and governance be to continue will Thisprogram enhanced during 2019.
Board of Directors
Howard Pien Shaun Thaxter Mark Crossley Chair Chief Executive Officer Chief Financial Officer Appointed to the Board Appointed to the Board Appointed to the Board November 4, 2014 November 4, 2014 February 21, 2017 Skills and experience Skills and experience Skills and experience ‹ Howard has more than 30 years of pharmaceutical and ‹ Shaun has more than 25 years of pharmaceutical and ‹ Mark has a wealth of financial and pharmaceutical biotechnology industry experience and brings strong prescription products industry experience. He is industry experience and knowledge and decisive leadership to the Board responsible for executing Indivior’s strategy and leading ‹ Indivior Chief Strategy Officer ‹ Vanda Pharmaceuticals, Inc.: Non-Executive Chairman the management team ‹ Reckitt Benckiser Pharmaceuticals Inc.: (2010-2016) ‹ Appointed CEO of Indivior at time of Reckitt Benckiser Global Finance Director ‹ GlaxoSmithKline: various executive positions Pharmaceuticals demerger ‹ Procter and Gamble: Associate Director Corporate (1991-2003) ‹ Institute of Directors (IoD): Chartered Director Portfolio Finance ‹ Chiron, Corp: President and CEO (2003-2006) and later and Fellow ‹ Procter and Gamble: Associate Director Female Beauty Chairman of the Board (2004-2006) ‹ National Association of Corporate Directors (NACD): Strategy and Business Planning ‹ Medarex Inc.: CEO and President (2007-2009) Board Leadership Fellow ‹ National Association of Corporate Directors (NACD): ‹ Abbott Laboratories and Merck & Co.: Product Manager, ‹ Reckitt Benckiser Pharmaceuticals, Inc.: President Board Leadership Fellow Business Unit Director, cardiovasculars, anti-infectives ‹ Reckitt Benckiser: Global Category Manager (1986-1991) Other appointments Other appointments None ‹ Juno Therapeutics: Non-executive Chairman (2014-2018) None Other appointments ‹ Idera Pharmaceuticals, Inc.: Director ‹ Sapience Therapeutics: Chairman
Daniel Tassé Yvonne Greenstreet MBChB A. Thomas McLellan PhD Senior Independent Director Non-Executive Director Non-Executive Director Appointed to the Board Appointed to the Board Appointed to the Board November 4, 2014 November 4, 2014 November 4, 2014 Skills and experience Skills and experience Skills and experience ‹ Daniel has a strong track record of leading global ‹ More than 20 years of pharmaceutical ‹ Tom’s extensive experience in the field of addictions organizations with more than 35 years of industry experience spans more than 35 years as a career researcher in the pharmaceutical and financial industry experience. ‹ Experienced in medicines development, medical affairs treatment and policy-making around substance use and He is an effective Senior Independent Director and business development abuse. This enables him to contribute valuable insight with a balanced understanding of the concerns ‹ Pfizer Inc.: SVP Medicines Development (2010-2013) and perspective to his work on Indivior’s Science & of major shareholders Policy Committee ‹ GlaxoSmithKline: various executive positions ‹ ‹ Ikaria Holdings, Inc.: CEO and President (2008-2015), (1992-2010) Published more than 450 articles and chapters on Chairman (2009-2015) addiction research ‹ Moelis & Company: Independent Director (2014-2018) ‹ Baxter International: General Manager of ‹ Treatment Research Institute (TRI): Co-founder, CEO Pharmaceuticals and Technologies Business Unit Other appointments and Chairman until September 1, 2016 ‹ GlaxoSmithKline: various senior management positions ‹ Alnylam: Chief Operating Officer ‹ White House Office of National Drug Control Policy including President and Regional Director for ‹ Pacira Pharmaceuticals, Inc.: Director (2009-2011): Deputy Director Australasia (2001-2004) Other appointments Other appointments ‹ Recover Together, Inc.: Director ‹ DBV Technologies SA.: CEO ‹ Serves on several editorial boards of scientific journals ‹ Bellerophon Therapeutics: Director ‹ HLS Therapeutics Inc.: Director ‹ REGENXBIO Inc.: Director
3838 www.indivior.com Governance 39 39
Chartered Secretaries and Indivior Annual Report 2018
TE Connectivity Ltd: Board Board Director Connectivity Ltd: TE More than 15 years of experience as a Chartered Secretary Dan possesses more than 30 years of pharmaceutical of 30 years than possesses more Dan and executive management including experience, dealing experience extensive executive with and an is He matters. active remuneration knowledgeable Chair of the Remuneration Committee and provides valuable perspective to the work of the Nomination & Governance Committee Disclosure Committee Committee Disclosure Committee Compliance Fellow of theFellow Institute of of CharteredAdministrators, Governance Professional GlaxoSmithKline: advisor to three CEOs and various executive positions (1981-2012) Kingfisher plc: Company Secretary (2012-2015) (2012-2015) Company plc: Secretary Kingfisher Computer Sciences Corporation: Advisory Board (2013-2015)Member Senior Company Secretarial positions at Burberry Group plc and ICAP plc RiseSmart: Advisory Board Member Board Advisory (2012-2016) RiseSmart: Rutgers MemberRutgers Trustees: of University Board (2013-2017) ppointed Company Secretary ppointed to the Board
Other appointments None Other appointments ‹ Kathryn Hudson Company Secretary A June 15, 2015 Skills and experience ‹ Daniel J. Phelan Non-Executive Director A 2014 November 4, Skills and experience ‹ ‹ ‹ ‹ ‹ ‹ ‹ ‹
r company experience,company Lorna s Directo Limited: g ital Holdin p Science & Policy Committee Committee & Policy Science Nomination Committee Committee Nomination Liz is a financial and risk expert with significant audit experience UK gained both US in risk and listed and organizations. Her financial skills and knowledge are valuable to the work of the Audit Committee in particular (1996-2011) positions executive senior various The Hartford: Boston Private Financial Holdings: Non-Executive Director With more than 25 years of executive 25 years of search, than more With consulting board assessment and management experience, and UK listed CapitalCVC Partners: Senior Advisor provides strong leadershipprovides on governance matters succession planning including Audit, Risk Compensation and Nomination Committee experience member Board SE2: Manchester Square Partners: Senior Advisor Advisor Senior Partners: Square Manchester Conducts board effectiveness reviews for FTSE for effectiveness reviews 100 Conducts board companies Legal & General: Non-Executive Director (2013-2016) Trustees, of Board Science Center: Connecticut Vice Chair Royal Horticultural Society: Trustee Spencer Stuart: Partner (1989-2008); led the private equity practice across Europe and the legal search practice globally Computer Sciences Corporation (2016-2017) Axis Ca National OperaStudio: Trustee BC Partners: Senior Advisor (2008-2016) (2008-2016) Advisor Senior Partners: BC Future Academies: Director (2014-2017) Future
ppointed to the Board ppointed to the Board
A September 1, 2016 Skills and experience ‹ Other appointments ‹ Lizabeth Zlatkus Non-Executive Director Lorna Parker Non-Executive Director A 2014 November 4, Skills and experience ‹ Other appointments ‹ ‹ ‹ ‹ ‹ ‹ ‹ ‹ ‹ ‹ ‹ ‹ ‹ ‹ ‹
ident and Chief Executive Audit Committee Committee Remuneration Chair
Aprea Therapeutics AB: Pres Officer Chris’s significant pharmaceutical and financial pharmaceutical financial significant and Chris’s experience gainedindustry more than over 20 years Chair strong companies of in US him a listed make the Audit Committee, able to challenge incisively to approach and performance financial the Group’s management risk EIP Inc; Non-ExecutiveEIP Inc; Director Tatjana combines substantial knowledge and and knowledge combines substantial Tatjana sector with more the pharmaceutical of understanding experience both UK brings legal and of 20 years than company US and listed expertise to Board discussions Integra LifeSciences Holdings Corporation: Director Corporation: Holdings LifeSciences Integra Novira Therapeutics, Inc.: CEO (2014-2015) Inc.: Therapeutics, Novira The National Youth Orchestra of Great Britain: Trustee Shire plc:Shire General Counsel Company and Secretary, Executive Committee Member (2001-2015) Sapience Therapeutics:Sapience Director Omthera Pharmaceuticals, Inc.: CFO, EVP Inc.: Pharmaceuticals, (2011-2013) Omthera AstraZeneca plc: various positions including Assistant General Counsel (1995-2001) NRG Energy, Inc.: CFO, EVP (2010-2011)CFO, Inc.: Energy, NRG Slaughter and May: Lawyer (1988-1994) Medarex Inc.: CFO, SVP (2000-2009) (2000-2009) SVP CFO, Inc.: Medarex Merrill Lynch & Co.: MD, Debt Capital Markets (1992-2000) Capital (1992-2000) Debt Markets & Co.: MD, Merrill Lynch ppointed to the Board ppointed to the Board
Other appointments ‹ Skills and experience ‹ Chris Schade Non-Executive Director A 2014 November 4, Other appointments ‹ A 2017 1, February Skills and experience ‹ Tatjana May Non-Executive Director
Committee Membership Key Membership Committee ‹ ‹ ‹ ‹ ‹ ‹ ‹ ‹ ‹ ‹ ‹ Our Board of Directors continued
Executive Committee
Shaun Thaxter Mark Crossley Debby Betz Chief Executive Officer Chief Financial Officer Chief Corporate Affairs and Professional experience and qualifications Professional experience and qualifications Communications Officer See biography on page 38 See biography on page 38 Professional experience and qualifications Key previous roles Key previous roles ‹ 25+ years See biography on page 38 See biography on page 38 Key previous roles ‹ Reckitt Benckiser Pharmaceuticals Inc.: Director of Marketing (North America) and Director of Commercial Development and Strategic Planning (North America) ‹ Purdue Pharma and Stuart Pharmaceuticals: Various sales and marketing leadership roles including District Sales Manager
Cindy Cetani Jon Fogle Christian Heidbreder Chief Integrity and Chief Human Resources Officer Chief Scientific Officer Compliance Officer Professional experience and qualifications Professional experience and qualifications Professional experience and qualifications ‹ 20+ years ‹ 25+ years’ leadership in neurosciences ‹ 30+ years ‹ Senior certified professional in human resources ‹ 350+ publications Key previous roles ‹ Affiliate Professor, Dept. Pharmacology and Toxicology, Key previous roles Virginia Commonwealth University School of Medicine ‹ Novartis Pharmaceuticals Corp: Chief Compliance ‹ Reckitt Benckiser Pharmaceuticals Inc.: Global Human Officer and Head of Compliance Operations, Group Resources Director Key previous roles Integrity & Compliance ‹ Reckitt Benckiser Pharmaceuticals Inc.: Human ‹ Reckitt Benckiser Pharmaceuticals Inc.: Global R&D ‹ Pharmacia: Director of Operations, Managed Markets Resources Director for the US Director ‹ Capmark Finance (formerly GMAC Commercial ‹ Altria: Client Services’ Health Sciences Mortgage): Senior Vice President of Human Resources, ‹ GlaxoSmithKline: Center of Excellence for Drug North America Discovery in Psychiatry ‹ SmithKline Beecham: Neuroscience Department
40 www.indivior.com Governance 41 41
als Inc.: Global Supply Indivior Annual Report 2018
25+ years PharmaceuticReckitt Benckiser Director (heading customer logistics, service, demand manufacturing) and planning Reckitt Benckiser Pharmaceuticals Inc.: Inc.: Pharmaceuticals Supply Services Reckitt Benckiser Director then Global Supply Services Director Reckitt Benckiser: SupplyReckitt Benckiser: Services Director, Central Europe Reckitt Benckiser: Industrial Customer Service Manager Industrial Reckitt Benckiser: Colgate-Palmolive GbmH: various roles
Ponni Subbiah was a member of the Executive Executive the of member a was Ponni Subbiah down from the and stood 2018 throughout Committee February 2019 in Committee Supply Officer Officer Supply Frank Stier and Manufacturing Chief Professional experience and qualifications ‹ Key previous roles ‹ ‹ ‹ ‹ ‹
20+ years20+ Pharmaceuticals Inc.: Reckitt Benckiser President, North America Reckitt Benckiser: General Manager Portugal General Manager Reckitt Benckiser: Reckitt Benckiser: Marketing Director Reckitt Benckiser: UK Healthcare Reckitt Benckiser: Two Global Category roles and a and a Two roles Category Global Reckitt Benckiser: positions Management General of number
Richard Simkin Chief Commercial and Officer Strategy Professional experience and qualifications ‹ Key previous roles ‹ ‹ ‹ ‹
Disclosure Committee Committee Disclosure Committee Compliance
15+ years Inc.: Pharmaceuticals VP General Reckitt Benckiser Counsel Admitted to practice Admitted to practice in New law New JerseyYork, and Virginia (Corporate Counsel) Counsel (Healthcare), Senior LLC: Benckiser Reckitt rights marketing to (ex-US) global the acquire helping to buprenorphine National Association of Corporate Directors Directors Corporate Association of National Governance Fellow Bayer AG and Berlex Laboratories, Inc.: Corporate Counsel avier Rodriguez Rodriguez avier
Key previous roles ‹ Professional experience and qualifications ‹ J
Committee Membership Key Membership Committee Chief Legal Officer ‹ ‹ ‹ ‹ Corporate Governance Report
Corporate governance
The Board is responsible for ensuring there is a robust and transparent governance framework in place.
We have a clear division of responsibilities between the Board and our various Committees; each role is clearly defined and is distinct from one another.
Indivior Board
Audit Committee Nomination & Remuneration Science & Policy Oversight of financial Governance Committee Committee reporting, audit and risk Committee Oversight of the link of Oversight of pipeline Oversight of Board reward to strategy research and composition, succession development and public planning, governance and policy strategy corporate compliance Principal Board Committees
Executive Committee Disclosure Committee Compliance Committee Oversight of the implementation of Oversight of disclosure and (new structure established in January 2019) the Group’s strategic plan reporting requirements and the Oversight of the Group’s compliance identification of inside information program
Executive Executive Committees
Board committees The Board has four principal committees, to which it has delegated certain responsibilities. These are the: Audit, Nomination & Governance, Remuneration and Science & Policy committees. Each committee operates under its own clearly defined Terms of Reference, available at www.indivior.com. More information about the roles, composition and work of the principal committees can be found in the Introduction to Board Committees on pages 50 to 77. The Chair of each principal committee reports on the activities of the committee at the following Board meeting. Copies of all papers and the minutes of meetings of the principal committees are available to all Directors. Executive committees In addition to the principal committees, the Group has three executive committees: Executive Committee The Executive Committee is chaired by the Chief Executive Officer. The Committee comprises key functional leaders from the business and its purpose is to assist the Chief Executive Officer in discharging his duties. The Executive Committee meets monthly. Biographical details of the members of the Executive Committee are on pages 40 to 41. Disclosure Committee The Disclosure Committee is chaired by the Chief Financial Officer. It comprises the Chief Financial Officer, the Chief Commercial and Strategy Officer, the Chief Legal Officer, the Chief Scientific Officer and the Company Secretary. The Committee meets as necessary and oversees the disclosure of information in accordance with the EU Market Abuse Regulation and the FCA’s Disclosure Guidance and Transparency Rules. The Disclosure Committee receives input and advice from relevant individuals and advisors as required. These include the Group’s brokers and external legal counsel. Compliance Committee An Executive Compliance Committee was established in January 2019, replacing the existing management compliance committee (which has been reorganized as the Compliance Administration Council, which now reports to the Compliance Committee). The Compliance Committee comprises all members of the Executive Committee and is chaired by the Chief Integrity and Compliance Officer. The Compliance Committee meets monthly and is responsible for overseeing compliance with applicable laws, rules and regulations related to Indivior’s business operations excluding compliance with securities regulations and financial reporting requirements.
42 www.indivior.com Governance 43 43 Indivior Annual Report 2018 Chair and Chief Executive and Chair Officer Executive Chief of division a is formal There Chair, the between responsibilities Howard Pien, and Chief Executive Officer, Shaun Thaxter, which is set Chief and Chair The writing. in out to together work Officer Executive set the Board’s agenda. The leads Board and Chair the is overall its ensuring for responsible high promotes He effectiveness. standards of governance corporate constructive fosters and probity and the Executive between relations Directors,and Non-Executive and the tone setting for is responsible andculture in the boardroom. Throughoutyear,the Chair the with worked closely the Senior the and Director Independent Non-Executive Directors. A part of for reserved is meeting Board each the and of the Chair a meeting Non-Executive Directors, without present. management executive is Officer Executive Chief The day-to-day the for responsible business, ofthe leadership including leading and monitoring theperformance ofsenior management.He isresponsible of performance the for Board the to the business against agreed strategy this in supported He is plans. and Committee. Executive the by role Senior Independent Director is Tassé Daniel the Senior a as He acts Director. Independent and Chair the for board sounding between can act as an intermediary Chair the and Directors other the the leads also required.He when other Non-Executive Directors in the annualperformance evaluation of Chair. the the Group’s annual budget and and budget annual Group’s the plans; corporate theGroup’s annual, half-yearly quarterlyand reports;financial the Annual Report and Accounts and the reports included therein; thedividend policy; all Board appointments or removals, remuneration termination and arrangements payments; of chairship and membership and Board and committees the senior for planning succession management; majorcapital projects, or divestments; acquisitions or significant in, increase any of the terms the in, variation borrowingfacilities of the Company; projects expenditure capital approved of scope the the outside annualandplans;budgets treasury and risk management policies; and and removalappointment of the Company Secretary.
‹ ‹ ‹ ‹ ‹ ‹ ‹ ‹ ‹ ‹ ‹ delegated Board The has day-to-day the for responsibility the to business the of management Executive Officer. Chief Boardcomposition composition Board’s the of Details areset out on pages 38 to39 which of details biographical contain Directors The Directors. the of each have a valuable combination of scientific, business, and skills pharmaceutical and disease be to continue which experience Group.the to relevant the Group’s strategic aims and and aims strategic Group’s the material including objectives, litigation strategy, and review of performanceagainst those aims objectives;and
The Board Board The responsible is collectively long- the for shareholders the to It Company. the of success term and leadership strategic provides of Group’s the oversight effective operations,either directly or principal its of work the through ultimate has Board The committees. good ensuring for responsibility governance throughout Indivior. matters of a schedule has Board The that are reserved to it for approval. in updated last was schedule The 2017,November and is available to website on view Group’s the www.indivior.com. of responsibilities and Roles Board the Board The responsible is collectively forthe long-term success of the value delivering for and Company to shareholders. The Board’s primary further and support to is focus theGroup’s purpose of pioneering for treatments life-transforming patients suffering from addiction co-occurrences. its and throughout regularly met Board The it Chair, the by Led year. the reviews the strategy, approves financial and operational performance,risk management and capital Group’s the appetite, by proposed plans and structure managementto implementagreed The that Board ensures strategy. to available are resources sufficient set. the objectives meet for responsible is Board The approval of: ‹
Corporate Governance Report continued
He provides an alternative point of Information and support any significant contract with the contact for shareholders on matters All Directors have direct access to Company or any of its subsidiaries that would not be appropriate for the advice and services of the during the year. them to discuss or resolve via the Company Secretary. Directors may External directorships Chair, Chief Executive Officer or Chief also obtain independent The Nomination & Governance Financial Officer. professional advice as required at Committee has approved a formal Non-Executive Directors the Company’s expense. policy in respect of external The Non-Executive Directors bring Non-Executive Director appointments for Executive an independent perspective to Independence Directors and members of the Board discussion. The Company has The Board monitors the Executive Committee. Executive benefited from the broad range of independence of the Non-Executive Directors may hold one non- skills and experience which the Non- Directors for the purposes of executive appointment, subject to Executive Directors provide from the Code. the approval of the Nomination & different businesses and fields, Governance Committee. Members of At its meeting in February 2019, the including finance, academic, the Executive Committee may hold Board considered the independence scientific, private equity and one non-executive appointment of each of the Non-Executive pharmaceutical sectors. subject to the approval of the Directors (other than the Chair, Executive Committee. Throughout the year they have who was deemed independent constructively challenged and by the Board at the date of his The Nomination & Governance developed the Group’s strategy, appointment) against the criteria Committee considers the other scrutinized the performance of specified in the Code, and commitments of the Chair of the management, agreed goals and determined that all remain Board and Non-Executive Directors. objectives, and monitored the independent of management and The Committee considers if any Group’s risk profile and reporting free from any relationship that potential conflict of interest is of performance. could interfere with their judgment. likely to arise as a result of the appointment. The Committee Company Secretary Conflicts of interest also considers the likely time The Company Secretary, Kathryn Processes exist for actual or commitment required from the Hudson, acts as Secretary to the potential conflicts of interest to be Directors’ other commitments and Board and the Remuneration and reviewed and disclosed and to make if this is likely to interfere with their Nomination & Governance sure Directors do not participate in ability to discharge their duties Committees. any decisions where they may have effectively (and having regard to a conflict or potential conflict. She supports the Chair and the ‘overboarding’ guidelines). The The Nomination & Governance Board in the execution of their Committee reports to the Board on Committee considers the other duties. She advises the Chair, its review and recommends if any significant commitments or external Chief Executive Officer and senior action is necessary. management on regulatory and interests of potential appointees governance matters. The Deputy as part of the selection process and During the year, the Committee Company Secretary (a suitably discloses them to the Board when reviewed the other commitments qualified member of the Company recommending an appointment. of the Chair and Non-Executive Directors. In particular, the Secretarial team) acts as Secretary Non-Executive Directors are Committee considered Daniel to the Audit and Science & required to inform the Board of any Tassé’s appointment as Chief Policy Committees. subsequent changes to such Executive Officer of DBV Technologies commitments, which must be pre- Biographical details of the Company SA in November 2018, and noted that cleared with the Chair if material. Secretary are on page 39. he has a transition plan to reduce The Company’s procedures for his other commitments during dealing with Directors’ conflicts the course of 2019. Following the of interest continued to operate Committee’s review, the Board effectively during the year. No has reviewed Mr Tassé’s other Director had a material interest or commitments and is satisfied that
44 www.indivior.com Governance 45 45 Indivior Annual Report 2018 Group and at senior leadership leadership and at senior Group in levels the organization (Executive Committeeand direct reports), where there is 36% representation. female Board, its Committees and our our and Committees its Board, workforce, reflects our beliefs and values. Supporting and our of diversity the promoting priority important an is people have we and Group the for an on developing focused values all that culture inclusive of their regardless employees age, disability, gender, race, sexualorientation or other We characteristics. protected targeted through this achieve offrom sourcing people diverse backgrounds and culturesand on creating focus ongoing an allows our that an environment talented people to prosper. Our Board and Executive are up of made Committee individuals from a broad, diverse strong includes this background; 36% comprising diversity gender women on 22%the Board and on the Executive Committee. This is consistent across the Diversity and Inclusion Diversity At Indivior, wevalue our believe and culture distinctive sustainable of source a is key it We advantage. competitive and diversity inclusion believe enables sense in its broadest continuous innovation, and quality, of improvement and efficiency speed increased of needs various the meeting in our patients, customersand stakeholders. Our Diversity and Inclusion to which the Policy, applies