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Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
---|---|---|---|---|---|
Indivior Plc | LSE:INDV | London | Ordinary Share | GB00BN4HT335 | ORD USD0.50 |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-5.00 | -0.35% | 1,435.00 | 1,454.00 | 1,456.00 | 1,474.00 | 1,437.00 | 1,440.00 | 355,661 | 16:35:08 |
Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
---|---|---|---|---|---|
Pharmaceutical Preparations | 1.09B | 2M | 0.0148 | 982.43 | 1.97B |
TIDMINDV
RNS Number : 3055A
Indivior PLC
23 March 2017
Indivior PLC ('Indivior' or the 'Company')
Annual Report and Accounts for the year ended December 31, 2016 ('Annual Report & Accounts 2016') and Annual General Meeting 2017 ('AGM')
The Company has today posted or made available to shareholders the following documents:
-- Annual Report & Accounts 2016;
-- Notice of AGM; and
-- Form of Proxy for the AGM.
In accordance with LR 9.6.1, these documents have been submitted to the National Storage Mechanism and will shortly be available for inspection at www.morningstar.co.uk/uk/NSM.
The Annual Report & Accounts 2016 and Notice of AGM can also be viewed on the Company's website at www.indivior.com/investors/.
The AGM is scheduled to be held at 3.00pm on Wednesday, May 17, 2017 in the Wessex Ballroom, Renaissance London Heathrow, Bath Road, Hounslow, Middlesex, TW6 2AQ.
A condensed set of Indivior's financial statements and information on important events that have occurred during the financial year ended December 31, 2016 and their impact on the financial statements were included in Indivior's preliminary results announcement released on February 22, 2017. That information, together with the information set out in the Appendix below, which is extracted from the Annual Report & Accounts 2016, constitute the material required by Disclosure Guidance and Transparency Rule 6.3.5 which is required to be communicated to the media in full unedited text through a Regulatory Information Service. This announcement is not a substitute for reading the full Annual Report & Accounts 2016. Page numbers and cross references in the extracted information refer to page numbers and cross references in the Annual Report & Accounts 2016.
March 23, 2017
Investor Contact
Jason Thompson
Vice President, Investor Relations
Indivior
Tel: +1 (804) 423 8916
jason.thompson@indivior.com
Forward-Looking Statements
The Annual Report & Accounts 2016 contains certain statements that are forward--looking and which should be considered, amongst other statutory provisions, in light of the safe harbour provisions of the United States Private Securities Litigation Reform Act of 1995. By their nature, forward--looking statements involve risk and uncertainty as they relate to events or circumstances that will or may occur in the future. Actual results may differ materially from those expressed or implied in such statements because they relate to future events. Forward--looking statements include, among other things, statements regarding the Indivior Group's financial guidance for 2017 and its medium-- and long--term growth outlook, its operational goals, its product development pipeline and statements regarding ongoing litigation. Various factors may cause differences between Indivior's expectations and actual results, including: factors affecting sales of SUBOXONE(R) (buprenorphine and naloxone) Sublingual Tablets (CIII), SUBOXONE(R) (buprenorphine and naloxone) Sublingual Film (CIII), SUBUTEX(R) (buprenorphine) Sublingual Tablets (CIII) and any future products; the outcome of research and development activities; decisions by regulatory authorities regarding the Indivior Group's drug applications; the speed with which regulatory authorizations, pricing approvals and product launches may be achieved; the outcome of post--approval clinical trials; competitive developments; difficulties or delays in manufacturing; the impact of existing and future legislation and regulatory provisions on product exclusivity; trends toward managed care and healthcare cost containment; legislation or regulatory action affecting pharmaceutical product pricing, reimbursement or access; claims and concerns that may arise regarding the safety or efficacy of the Indivior Group's products and product candidates; risks related to legal proceedings; the Indivior Group's ability to protect its patents and other intellectual property; the outcome of the SUBOXONE Film patent litigation relating to the ongoing ANDA lawsuits; changes in governmental laws and regulations; issues related to the outsourcing of certain operational and staff functions to third parties; uncertainties related to general economic, political, 13 business, industry, regulatory and market conditions; and the impact of acquisitions, divestitures, restructurings, internal reorganizations, product recalls and withdrawals and other unusual items.
Any forward-looking statements that we make in the Annual Report & Accounts 2016 speak only as of the date of the Annual Report & Accounts 2016. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of the Annual Report & Accounts 2016.
The Annual Report & Accounts 2016 does not constitute an offer to sell, or the solicitation of an offer to subscribe for or otherwise acquire or dispose of shares in the Company to any person in any jurisdiction to whom it is unlawful to make such offer or solicitation.
APPIX
i. Statement of Directors' Responsibilities
The Directors are responsible for preparing the Annual Report, the Directors' Remuneration Report and the financial statements in accordance with applicable law and regulations.
Company law requires the Directors to prepare financial statements for each financial year. Under that law the Directors have prepared the Group financial statements in accordance with International Financial Reporting Standards ('IFRS'), as adopted by the European Union, and the Parent Company financial statements in accordance with United Kingdom Generally Accepted Accounting Practice (United Kingdom Accounting Standards, comprising FRS 101 "Reduced Disclosure Framework", and applicable law).
Under company law the Directors must not approve the financial statements unless they are satisfied that they give a true and fair view of the state of affairs of the Group and Parent Company, and of the profit or loss of the Group and parent Company for that period. In preparing these financial statements, the Directors are required to:
-- select suitable accounting policies and then apply them consistently;
-- make judgments and accounting estimates that are reasonable and prudent;
-- state whether IFRS as adopted by the European Union have been followed for the Group financial statements and the United Kingdom Accounting Standards, comprising FRS 101, have been followed for the Company financial statements, subject to any material departures disclosed and explained in the financial statements; and
-- prepare the financial statements on the going concern basis, unless it is inappropriate to presume that the Group and Parent Company will continue in business.
The Directors are responsible for keeping adequate accounting records that are sufficient to show and explain the Group's and Parent Company's transactions, and disclose with reasonable accuracy, at any time, the financial position of the Group and the Parent Company, and enable them to ensure that the financial statements and the Directors' Remuneration Report comply with the Companies Act 2006 and, as regards the Group financial statements, Article 4 of the IAS Regulation. They are also responsible for safeguarding the assets of the Parent Company and the Group and hence for taking reasonable steps for the prevention and detection of fraud and other irregularities.
Under applicable law and regulations, the Directors are also responsible for preparing a Strategic Report, Directors' Report, Directors' Remuneration Report and Corporate Governance Statement that complies with that law and those regulations.
The Directors are responsible for the maintenance and integrity of the Group and Parent Company's website. Legislation in the United Kingdom governing the preparation and dissemination of financial statements may differ from legislation in other jurisdictions.
Responsibility statement of the Directors in respect of the Annual Report
The Directors consider that the Annual Report and Accounts, taken as a whole, are fair, balanced and understandable, and provide the information necessary for shareholders to assess the Group and Parent Company's position and performance, business model and strategy.
Each of the Directors, whose names and functions are listed on page 58, confirm that, to the best of their knowledge:
-- the Parent Company financial statements, which have been prepared in accordance with United Kingdom Generally Accepted Accounting Practice (United Kingdom Accounting Standards, comprising FRS 101 "Reduced Disclosure Framework", and applicable law) give a true and fair view of the assets, liabilities, financial positions and profit of the Company;
-- the Group financial statements, which have been prepared in accordance with IFRSs as adopted by the European Union, give a true and fair view of the assets, liabilities, financial position and profit of the Group; and
-- the Directors' Report and Strategic Report, includes a fair review of the development and performance of the business and the position of the Group and Parent Company, together with a description of the principal risks and uncertainties that it faces.
ii. Risk Factors and Risk Management
The Board of Directors have carried out a robust assessment to ensure that the principal risks, including those that would threaten the Group's business model, future performance, solvency or liquidity are effectively managed and/or mitigated to help ensure the Group is viable. While the Group aims to identify and manage such risks, no risk management strategy can provide absolute assurance against loss.
Set out below are what the Group considers to be the principal risks that could cause the Group's business model, future performance and solvency or liquidity to differ materially from expected and historical results, and how the risks relate to the Group's strategic priorities. Additional risks, not listed here, that the Group cannot presently identify or does not believe to be equally significant, may materially and adversely affect the business, results of operations and financial position. The principal risk factors and uncertainties are not listed in order of significance.
Principal risks
Business operations and business continuity
-- The Group's revenues are primarily derived from sales of Suboxone(R) Film and any decrease in sales due to competition or supply or quality issues could significantly affect the results of operations and prospects.
-- Competition for qualified personnel in the biotechnology and pharmaceutical industries is intense, and high-performing talent in key positions is a business-critical requirement.
-- Failures or disruptions to the Group's systems, or the systems of third parties on whom the Group relies, due to any number of causes, particularly if prolonged, could result in a loss of key data and/or affect operations.
-- The Group's systems, software and networks may be vulnerable to unauthorized access, computer viruses or other malicious code or cyber threats that could have a security impact. All of these could be costly to remedy and we may be subject to litigation.
-- The Group has a single source of supply for buprenorphine, an active ingredient in the Group's products including Suboxone(R) Film, and any disruption to this source of supply could significantly affect the Group's results, operations, and prospects.
Specific risks How we manage Possible Link to strategic we may face risk impacts priorities ------------------------ ------------------------ ------------------------ ------------------------ Dependence Continue Hinder patient Build resilience on single to expand access to of our franchise. product line. the market treatment. Expand global Approval by expanding Loss of treatment. and launch access to market share. Business development. of generic treatment Loss of or branded and working revenue and products that with physicians profits, compete with and payors which in our products. to improve worst case Generic manufacturers patient outcomes. scenarios seeking approval Capitalize may require to launch on international business competing growth opportunities, restructure products prior continued and recapitalization. to expiry development Damage to of existing of our pipeline reputation. patents. and disciplined Exposure Launch of acquisitions to litigation branded products to enable and significant that compete diversification. legal costs. with our products. Obtain and Claims that enforce product our products patents and infringe third other IP -party patents. rights, and Inability develop and to deliver implement continuous strategies, supply of including compliant new product(s), finished product. to face both Inability generic competition, to retain if the outcome or attract of patent high-performing litigation and high-potential is unfavorable, staff could and new and adversely existing impact achievement branded competitors. of Develop Group objectives. and implement Significant strategies disruptions to ensure of information freedom to technology operate. systems or Explore breaches of settlement data security opportunities. could disable Continuity critical systems planning and cause for certain loss of sensitive black swan data. events to Failure to secure business protect and continuity restrict access in worst to critical case scenarios. or sensitive Establish computer systems and closely or information. monitor stock levels. Ongoing partnerships with manufacturers and packagers to optimize manufacturing and Quality Assurance (QA) processes. Continuously review talent retention program with focus on identifying key roles and successors. IT disaster recovery plans in place to support overall business continuity. Systems in place to protect data and devices. Various IT policies, processes and systems in place to provide access control and security management for Indivior-used or owned infrastructure and applications, now operating independently from RB. Completed initial and continuing ongoing End User Cyber Security Awareness training. ------------------------ ------------------------ ------------------------ ------------------------
Product liability, regulation and litigation
-- As an innovative pharmaceutical company, the Group seeks to obtain appropriate intellectual property protection for its products. Its ability to obtain and enforce patents and other proprietary rights particularly for its products, drug formulation and delivery technologies and associated manufacturing processes is critical to business strategy and success. Specifically see disclosures on pages 44 to 45 referring to the current status of ANDA litigation and to the going concern statement on page 95 contained within the Statement of Directors' Responsibilities, which discusses the risks associated with current ANDA litigation, and the contingent liabilities disclosures in Note 20 of the financial statements on page 126.
-- The manufacture of the Group's products is highly exacting and complex, due in part to strict regulatory and manufacturing requirements. Active Pharmaceutical Ingredients (API) in many of the Group's products and product candidates are controlled substances that are subject to extensive regulation in all the countries in which the Group markets its products.
-- The testing, manufacturing, marketing, and sale of pharmaceutical products are highly regulated and entail a risk of product liability claims, product recalls, litigation, government investigations and enforcement action, and associated adverse publicity, each of which could have a material adverse impact on the business, prospects, results of operations and financial condition. Specifically, see disclosure on page 44 referring to the current status of the DOJ investigation and other investigative and antitrust litigation matters, and the contingent liabilities disclosures in Note 20 of the financial statement on page 125.
Specific risks How we manage Possible impacts Link to strategic we may face risk priorities ----------------------- --------------------- -------------------- --------------------- Failure to Obtain and Loss of revenue Build resilience obtain, maintain, enforce patents and profits. of our franchise. and protect and other Adverse impact patents and proprietary on the Group's other proprietary rights. ability to rights, including Suboxone(R) raise funds
potential Film in the necessary invalidity US is covered to continue or non- infringement by three Orange its operations. findings in Book-listed the current formulation US Federal patents and Court or US two process Patent and patents, having Trademark terms that Office proceedings. run from 2022 Legal proceedings to 2030, which related to are currently product liability in litigation claims, antitrust, in the US government Federal Court enforcement and/or US and/or private Patent and litigation Trademark associated Office. with the testing, Develop and manufacturing, implement marketing strategies, and sale of including our products. new product(s), Potential to prepare liability for generic and/or additional competition expenses associated in the event with ongoing of adverse regulatory outcomes in obligations these proceedings. and oversight. Quality, product safety and compliance are embedded in the Group's processes and culture and monitor and oversee the Company's activities. Develop and implement strategies to defend against and pursue appropriate resolution of these claims. The Group has instituted policies, systems, and training programs to ensure adherence to regulations governing product quality, patient safety and business standards. ----------------------- --------------------- -------------------- ---------------------
Product development
-- The regulatory approval process for new pharmaceutical products and expansion of existing pharmaceutical products is expensive, time-consuming and uncertain.
-- Even if product candidates are approved, there is no guarantee that they will be able to achieve expected market acceptance.
Specific risks How we manage Possible impacts Link to strategic we may face risk priorities --------------------------- ------------------------ -------------------------- ------------------ Failure to Increased Potential Develop our receive regulatory R&D investment delays or pipeline. approval to to enhance inability Expand global successfully clinical capabilities to develop treatment. commercialize and support new products. a pipeline the development Hinder patient product. of pipeline access to Failure of products. treatment. third-party Thorough Loss of revenue Clinical Research contract review and profits, Organizations process in which in worst to properly/successfully place to ensure case scenarios perform their that third-party may require legal, regulatory, vendors are business restructure and contractual properly vetted, and recapitalization. obligations. inherent risks Damage to Inability are identified reputation. of product and mitigated, Adverse impact candidates, and deliverables to long-term if approved, and obligations growth. to achieve are clearly Adverse impact expected market defined before on the Group's acceptance. contracts ability to are finalized. raise funds Ongoing monitoring necessary of the third-parties' to continue activity and its operations. performance to ensure that good clinical practices ('GCP') are being followed and milestones are met. Financial models and external support in place to provide market valuation and due diligence support. --------------------------- ------------------------ -------------------------- ------------------
Commercial and governmental payor account, pricing and reimbursement pressure
-- The Group's revenues are partly dependent on the availability and level of coverage provided to the Group by private insurance companies and governmental reimbursement schemes for pharmaceutical products, such as Medicare and Medicaid in the US.
-- Changes to governmental policy or practices could adversely affect the Group's revenues, financial condition and results of operations. In addition, the reimbursement of treatment established by healthcare providers, private health insurers and other organizations may be reduced.
Specific risks How we manage Possible impacts Link to strategic we may face risk priorities --------------------------- --------------------- ------------------- --------------------- Reduced reimbursement Continue Loss of revenue Build resilience levels and to work with and profits. of our franchise. increasing payors, commercial Hinder patient Expand global pricing pressures. or governmental, access treatment. (e.g. as a to ensure to treatment. result of access to increasing and coverage competition). of our products. Price reductions Establishment as a result of health of commercial economic business and governmental case to justify payor austerity existing pricing. measures (e.g. price controls, policy change, or other price-setting action). --------------------------- --------------------- ------------------- ---------------------
Compliance with law and ethical behavior
-- Business practices in the pharmaceutical industry are subject to increasing scrutiny by government authorities. Failure to comply with applicable laws and rules and regulations in any jurisdiction may result in fines, civil and/or criminal legal proceedings, each of which could have a material adverse impact on the business, prospects, results of operations and financial condition. Specifically see disclosure on page 44 referring to the current status of the DOJ investigation and other investigative and antitrust litigation matters, and the contingent liabilities disclosures in Note 20 of the financial statements on page 125.
Specific risks How we manage Possible impacts Link to strategic we may face risk priorities -------------------------- ----------------------- -------------------------- --------------------- Non-compliance The Group Loss of revenue Build resilience with anti- has enhanced, and profits, of our franchise. corruption, and continues which in worst Expand global healthcare, to enhance, case scenario treatment. data privacy, its compliance may require or local laws program and business restructure could result compliance and recapitalization. in business capabilities. Fines and/ interruption All employees or penalties. or restructuring, required to Hinder patient
fines, loss complete a access to of reimbursement, comprehensive treatment. damage to compliance reputation training program and annually. criminal penalties. Reviews and Failure to controls put comply with in place over payment and government reporting pricing and obligations reporting. under the Increased US Medicaid oversight Drug Rebate and monitoring program or of controls other governmental and procedures pricing programs. in emerging Restrictions markets. on Group's The Group ability to has enhanced, sell products and continues or product to enhance, candidates its compliance in certain program and markets/ countries compliance due to controlled capabilities. substance Continued legislation, cooperation regulation, with the authorities and/or classification. on ongoing Government investigations, investigations utilizing of the Group's external counsel business activities as needed. alleged to be improper. -------------------------- ----------------------- -------------------------- ---------------------
Acquisitions and business development
-- The Group may seek to acquire businesses or products as part of our strategy to enhance our current portfolio.
Specific risks How we manage Possible impacts Link to strategic we may face risk priorities ------------------------ ----------------------- -------------------- --------------------- Inability Board of Adverse impact Build resilience to identify, Directors on Group's of our franchise. acquire, close reviews all ability to Business or integrate significant raise funds development. acquisition transactions. necessary Expand global targets successfully. Best Practice to continue treatment. Acquisitions Management its operations. Develop our and strategic Tools for Loss of revenue pipeline. alliances, Diligence and profits. including and Integration Damage to distributor Planning and reputation. collaboration, Execution may be unsuccessful. have been Inability developed. to raise capital Acquisition in order to Governance finance acquisitions. Model agreed, along with identification of SME required for Acquisition Integration team. Internal and external resources in place to ensure rigorous due diligence and integration of acquisitions and/or new product initiatives. Ongoing regular appraisal of debt and equity capital markets advisors and counterparties. ------------------------ ----------------------- -------------------- ---------------------
Product safety
-- The pharmacovigilance process has been established to monitor the safety of the Group's products in a comprehensive and thorough manner. This includes capturing safety-related data from multiple sources (e.g. Medical Information Unit (MIU), market research, literature search and clinical trials) and entering all adverse events received into a safety database. The Company reports to health authorities across the globe within the required and mandatory timelines and identifies safety signals with an assessment of changes to benefit/risk profile and determines actions needed to optimize the safe and effective use of our products, including communicating any relevant changes to key stakeholders.
Specific risks How we manage Possible impacts Link to strategic we may face risk priorities ---------------------------- --------------------- ------------------ -------------------- Change in Quarterly Product recall. Build resilience benefit-risk reviews performed Hinder patient of our franchise. profile based by Global access of Expand global on cumulative Signal detection treatment. treatment. evidence internally team of all Significant (from all potential legal cost. Indivior cross-functional safety sources Adverse impact departments) across Indivior on the Group's and externally. organization ability to and externally. raise funds Recommended necessary actions (e.g. to continue Labelling its operations. changes, Risk Loss of revenue Management and profits. Plan update, Damage to Dear Dr. Letters, reputation. Post-Authorization Safety Studies) approved by the Global Signal management team to optimize the safe and effective use of all Indivior products. ---------------------------- --------------------- ------------------ --------------------
Risk management
To achieve our objective of being the leading pharmaceutical company focused on the treatment of addiction, we recognize that we must have a good understanding of the risks we face, those inherent in our strategy and operations, and those presented by external conditions. We take a systematic and robust approach, which aims to continuously monitor those risks and internal control systems accordingly.
Our approach
Our systematic risk management approach is designed to identify risks that would threaten the Group's business model, future performance, solvency or liquidity. Effective risk management is fundamental to our ability to meet our operational and strategic objectives. The competitive market in which we operate has industry-specific risks, particularly those relating to new product development, intellectual property enforcement and legal proceedings, and compliance with laws and regulations. This requires effective decision-making to ensure that the risks the business takes are assessed and appropriately measured, whilst ensuring that there is overall resilience to risks the business has limited control over through disaster recovery and business continuity procedures. Our overall risk management approach remains to foster and embed a culture of risk management that is responsive, forward-looking, consistent and accountable.
The Executive Committee helps to establish the risk agenda, for the reporting and ongoing management of risks and for the stewardship of the risk management approach. The Executive Committee reviews the risk register on a quarterly basis and identifies and assesses Indivior's principal risks on an ongoing basis.
Risk control assurance
The Board has overall responsibility for the Group's risk management framework. The Board reviews the Group's principal risks with focus on the key risk areas framework. The Board's Committees regularly review risks relevant to their area of focus; this includes, but is not limited to, risks relating to legal, financial and compliance matters. Assurance on risk controls is provided by internal management information, internal audits, external audits and Board oversight. There is also an externally supported whistleblowing reporting system in place.
iii. Related party transactions
Subsequent to the demerger from former parent, RB, on December 23, 2014, Indivior continues to receive certain services like office space rental and other operational services on commercial terms and on an arm's length basis. Adrian Hennah, the RB CFO, served on the Indivior PLC Board of Directors until the AGM on May 11, 2016. The amount included within SD&A in respect of these services is $4m (2015: $9m).
Key management compensation is disclosed in Note 6a.
The subsidiary undertakings included in the consolidated Financial Statements at December 31, 2016 are disclosed in Note 2 to the Parent Company Financial Statements.
This information is provided by RNS
The company news service from the London Stock Exchange
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