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Download the Full Indivior Annual Report 2017 (Pdf 11.05 Annual Report 2017 Many journeys, one destination Annual Report 2017 Indivior is a global specialty pharmaceutical company and a world leader in addiction treatment Contents Strategic report 1 2017 Highlights 2 Chairman’s statement 4 At a glance – the global burden of disease 6 A patient’s journey: Nathan 10 Business model 12 Chief Executive Officer’s statement 18 A patient’s journey: Miguel 22 Stakeholder engagement 28 Research & development 34 Managing our business responsibly 42 Financial review 46 Litigation update 48 Risk management Nathan’s story page 6 57 Viability statement Governance 58 Chairman’s introduction to Corporate Governance 60 Our Board of Directors 62 Our Executive Committee 64 Corporate governance report 83 Directors’ remuneration report 107 Directors’ report 111 Statement of Directors’ Responsibilities Financial 113 Independent Auditor’s Report 121 Financial Statements 152 Information for shareholders Miguel’s story page 18 155 References and sources Our Purpose is to pioneer Our name is iconic life-transforming treatment. Our Vision is that all patients Our name is iconic of the individual around the world have access to evidence-based treatment for patient’s journey to reclaim life from the chronic conditions and the disease of addiction and our co-occurring disorders of addiction. endeavor to address patients’ Our Mission is to be the global unmet needs. leader who is a pioneer in developing innovative Our logo radiates our patient focused, prescription treatments for holistic approach to expanding access addicted patients. to evidence-based treatment for addiction worldwide. 2017 Highlights 2017 was a year of significant Strategic Report accomplishment for Indivior. By executing strongly across the business, we continued to build Governance our leadership position in treating addiction and its co-occurring disorders. Statements Financial $1,093m 57% 874,481 Net revenue US average market share US unique patients received (+3% vs 2016: $1,058m) (vs 2016: 61%) SUBOXONETM Film (vs. 2016: 842,176) $193m $58m 8c Operating profit Net income Earnings per share (+30% vs. 2016: $149m) (+66% vs. 2016: $35m) (+60% vs. 2016: 5c) $403m $270m 37c Adjusted operating profit* Adjusted net income* Adjusted earnings per share* (+4% vs 2016: $387m) (+6% vs 2016: $254m) (cents per share) (+6% vs 2016: 35c) *excluding exceptional items (further details on page 45.) Key pipeline highlights $89m One Six Twelve R&D investment US FDA Peer-reviewed Published (-25% vs. approval publications conference 2016: $119m) abstracts Indivior Annual Report 2017 1 Chairman’s statement Building the business and strengthening core assets to best serve the needs of patients “In 2017, the Board worked in close partnership with Indivior’s Executive Committee to ensure that the Group is best positioned to generate long- term value for all of its stakeholders. We did so by strengthening Indivior’s core assets – our people, culture, relationships, intellectual property and capital base – all the while making great strides toward our vision that all patients will have access to evidenced-based treatment for the chronic conditions and co-occurring disorders of addiction.” Howard Pien Chairman The Board’s mission is excellence 2017 was also a year in which we the Group continued to invest in in governance, while collaborating continued to enhance Indivior’s Compliance, as well as in improving with Indivior’s Executive Committee platform for growth. With the Board’s Indivior’s already-strong capabilities to build a lasting foundation support, the Executive Committee is across all corporate functional for growth. I am proud that our investing in launching SUBLOCADE areas, including R&D, Medical, collective efforts have resulted in with excellence and is creating a new Legal and Finance. a company that is well-positioned business unit to house and launch to produce future benefits for all RBP-7000 (monthly risperidone Management and the Board stakeholders, especially for patients long-acting injectable), if approved. To maintain the balance of skills, around the world. We are also working closely with knowledge and experience of our the Executive Committee to identify Board members, we appointed a new Key achievements in 2017 assets with the potential to broaden Executive Director, Mark Crossley, The Group (Indivior PLC and its the Group’s opportunity set within and a new Non-Executive Director, subsidiaries) has an exceptionally addiction and its co-occurring Tatjana May. Both Mark and Tatjana able and experienced Executive disorders. The work we did to bring a wealth of financial and legal Committee who, working side-by-side, establish a strategic collaboration experience to the Group, respectively. lead a group of employees that are with Addex Therapeutics is a good During the year, Cary Claiborne committed to the improvement example of this. Also, in concert stepped down from the Board, and of patient lives. Toward that end, with the Executive Committee, we we would like to thank him for his the year’s major milestone was are proactively identifying business valuable contributions. Those Board US Food and Drug Administration risks and implementing strategies members appointed on demerger (FDA) approval of SUBLOCADE™ to manage them. We are prudently from Reckitt Benckiser in 2014 were (buprenorphine extended-release) investing in the right areas – reappointed for a further three-year injection for subcutaneous use people, processes and technology term, thereby ensuring stability and (CIII), which is now available in the – to mitigate identified internal and continuity at the Board level. US. You can read more about this external risks to Indivior. significant treatment innovation It goes without saying that integrity in our Chief Executive Officer’s is at the core of all our activities. This statement on page 12. is an area, we, as a Board, together with the Executive Committee, take seriously and are committed to strengthening. As part of this effort, 2 www.indivior.com During the year, the Board also guarantee in terms of when these Outlook Strategic Report reviewed the composition of the matters may be settled and what the We look to the future with Board Committees. As a result, ultimate impact to Indivior will be. We confidence. In 2018, we will continue Lizabeth Zlatkus has joined the continue to cooperate fully with the to build on our strong foundation Science & Policy Committee and various parties and are hopeful for and develop our business with a Daniel Tassé has re-joined the resolution in a timely manner. focus on creating sustainable value Remuneration Committee. for our shareholders and wider Governance stakeholders. We will also seek to Risks, challenges and In 2017, we also commissioned an drive commercial success through Governance uncertainties external Board evaluation to assess pioneering new technologies to A significant risk presented in 2017 our corporate governance framework. meet unmet patient needs. Addiction was the potential negative financial We conducted a full review of our remains one of the largest public impact of the Court ruling in the Dr. remuneration policy and continued to health crises of our time and we Reddy’s patent infringement lawsuit. engage with and proactively keep our will continue to work tirelessly to Although the US District Court for the shareholders apprised of the strategy advance global treatment options District of Delaware ruled that our and execution of both our near and to help meet this challenge. patents were valid, it also ruled that long-term goals. Statements Financial I look forward to meeting many of Dr. Reddy’s did not infringe them. We you in the year ahead. are appealing this decision; however, Share price performance the Group is at risk of potential and dividend significant loss of market share for We outperformed the indices by Howard Pien SUBOXONE® (buprenorphine and which we measure ourselves. Our Chairman naloxone) Sublingual Film (CIII) in total shareholder return in 2017 was the US if Dr. Reddy’s (or another 37%. This compares to 18% for the generic manufacturer) receives FDA FTSE 250 Index of which Indivior is approval for their generic version of a member, representing almost 20 SUBOXONE Film, and decides to enter percentage points of outperformance. the market ‘at-risk.’ Given our ongoing investments in The Group has sought to address this pipeline and market development, and risk by obtaining intellectual property the need to preserve our capital in the protection for its products and by event of launch of a generic competitor developing robust contingency plans to SUBOXONE Film in the US in 2018, including focusing on a successful we made no dividend payments launch of SUBLOCADE™ in the US during 2017. This situation is unlikely and pipeline development. This to change in the year ahead. We do, enterprise-level approach, led by however, recognize the importance our strong Executive Committee, is of returning value directly to our intended to help counterbalance investors and will continue to any potential future uncertainty evaluate as this year progresses. or financial loss were we to fail to obtain, maintain and protect patents and other proprietary rights, including potential invalidity or non- infringement findings in the current US Federal Court or US Patent and Trademark Office proceedings. In relation to the various litigation and investigational matters, summarized on pages 46 to 47, the Board agreed with the Executive Committee that it was prudent to increase the provision related to these matters to $438 million to reflect collectively their current status. Since these matters are ongoing we cannot provide any Indivior Annual Report 2017 3 At a glance – the global burden of disease We are in a unique position to address this global epidemic Our patient-focused A human crisis ࢀ In the United States alone, opioid Addiction is a chronic condition use disorder is an epidemic and is platform – people, reaching epidemic proportions – accelerating. culture, collaboration and a global human crisis we are The US Centers for Disease Control and evidence-based committed to helping address.
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