REG - Indivior PLC - Notice of AGM <Origin Href="QuoteRef">INDV.L</Origin>

IndiviorAnnouncement

10/04/2015 08:30

RNS Number : 8410J
Indivior PLC
10 April 2015
Indivior PLC ("Indivior" or the "Company") 
ANNUAL REPORT AND NOTICE OF AGM 
The Annual Report and Financial Statements 2014 for the Company was posted out today to shareholders who have requested copies together with the circular containing the Notice of the 2015 Annual General Meeting to be held at 3.00pm on Wednesday, May 13, 2015 at the London Marriott Hotel Grosvenor Square, Grosvenor Square, London, W1K 6JP. 
Copies of both the Annual Report 2014 and the AGM circular are available to view or download from the Company's website using the links below, and will also shortly be available for inspection through the National Storage Mechanism at http://www.morningstar.co.uk/uk/.
Annual Report and Financial Statements 2014: http://indivior.com/news-type/annual-reports/
2015 Notice of Annual General Meeting: http://indivior.com/investors/shareholders/annual-general-meeting/
A condensed set of Indivior's financial statements and information on important events that have occurred during the financial year ended December 31, 2014 and their impact on the financial statements were included in Indivior's preliminary results announcement released on February 11, 2015. That information, together with the information set out below, which is extracted from the Annual Report 2014, constitute the material required by Disclosure 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 2014. Page and note references in the text below refer to page numbers in the Annual Report 2014 and notes to the Financial Statements
April 10, 2015
Enquiries: 
Lola Emetulu 
Company Secretary 
Indivior PLC 
Telephone: +44 (0) 1753 217800 
Cautionary Note Concerning Forward Looking Statements 
The Annual Report 2014 contains forward-looking statements. We may, in some cases, use terms such as "predicts", "believes", "potential", "proposed", "continue", "estimates", "anticipates", "expects", "plans", intends", "may", "could", "might", "will", "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the future strategy and performance of the Group.
Various factors may cause differences between Indivior's expectations and actual results, including: factors affecting sales of Suboxone Tablet, Suboxone Film, Subutex Tablet and any future products; the outcome of research and development activities; decisions by regulatory authorities regarding the 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 Group's products and product candidates; risks related to legal proceedings; the Group's ability to protect its patents and other intellectual property; the outcome of the Suboxone Film patent litigation relating to the three ongoing Abbreviated New Drug Application (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, 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 2014 speak only as of the date of the Annual Report 2014. 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 2014. 


APPENDICES
(i) PRINCIPAL RISKS 
The Group has adopted a risk management strategy designed to identify, assess and manage the significant risks that it faces. 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 consider to be the principal risks that could cause the Group's business, financial position, and results of operations 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 our business, results of operations and financial position. The principal risk factors and uncertainties are not listed in order of significance.
Business operations and business continuity
The Group's revenues are primarily derived from sales of Suboxone 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 our systems or the systems of third parties on whom we rely, due to any number of causes, particularly if prolonged, could result in a loss of key data and/or affect our operations. Our computer 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. 
Specific risks we may face
How we manage risk
Possible impacts
Link to Strategic Priority
 Dependence on single product line.
 Approval and launch of generic or branded products that compete with our products.
 Inability to deliver continuous supply of compliant finished product.
 Inability to retain or attract high-performing and high-potential staff could adversely impact achievement of group objectives.
 Significant disruptions of information technology systems or breaches of data security could disable critical systems and cause loss of sensitive data.
 Inability of the organization to operate independently post separation from previous owners.
 Continue to expand the market by expanding access to treatment and working with physicians and payors to improve patient outcomes.
 Capitalize on international growth opportunities and disciplined acquisitions.
 Obtain and enforce product patents and other IP rights.
 Establish and closely 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 and data recovery plans in place to support overall business continuity plans.
  Established a separation steering committee to monitor separation activities and transitional services agreement.
 Hinder patient access to treatment.
 Loss of market share.
 Loss of revenue and profits.
 Damage to reputation.
  Exposure to litigation.
 Build resilience of our franchise.
 Expand global treatment.
  Business Development.
Product safety, regulation and litigation
As an innovative pharmaceutical company, we seek to obtain appropriate intellectual property protection for our products. Our ability to obtain and enforce patents and other proprietary rights particularly for our products, drug formulation and delivery technologies and associated manufacturing processes is critical to our business strategy and success.
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 we market our products.
The testing, manufacturing, marketing, and sales of pharmaceutical products entail a risk of product liability claims, product recalls, litigation, and associated adverse publicity, each of which could have a material adverse impact on the business, prospects, results of operations and financial condition. 
Specific risks we may face
How we manage risk
Possible impacts
Link to Strategic Priority
 Failure to obtain, maintain, and protect patents and other proprietary rights.
 Events such as product liability claims, patient adverse drug experiences, enforcement against improper promotional activities and product recalls.
  Potential liability and/or additional expenses associated with ongoing regulatory obligations and oversight.
 Obtain and enforce patents and other proprietary rights. Suboxone Film in the US is covered by three Orange Book-listed formulation patents and two process patents having terms that run from 2022 to 2030.
 Quality, safety and compliance are embedded in the Group's culture. The Group has instituted policies, systems, and training programs to ensure adherence to regulations governing product quality, patient safety and business standards.
  Regulatory Excellence program in place to ensure product compliance with dossier requirements.
 Loss of revenue and profits.
 Significant legal costs.
 Damage to reputation.
  Adverse impact on Group's ability to raise funds necessary to continue its operations.
  Build resilience of our franchise.


New product development
The regulatory approval process for new 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 we may face
How we manage risk
Possible impacts
Link to Strategic Priority
 Failure to receive regulatory approval to successfully commercialize a pipeline product.
 Failure of third-party Clinical Research Organizations to properly/successfully perform their legal, regulatory, and contractual obligations.
  Inability of product candidates, if approved, to achieve expected market acceptance.
 Increased R&D investment to enhance clinical capabilities and support the development of pipeline products.
 Thorough contract review process in place to ensure that third-party vendors are properly vetted, inherent risks are identified and mitigated, deliverables and obligations are clearly defined before contracts are finalized.
 Ongoing monitoring of the third party's activity and 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.
 Potential delays or inability to develop new products.
 Hinder patient access to treatment.
 Loss of revenue and profits.
 Damage to reputation.
  Adverse impact to long-term growth.
 Develop our pipeline.
  Expand global treatment.
Government 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 we may face
How we manage risk
Possible impacts
Link to Strategic Priority
 Reduced reimbursement levels and increasing pricing pressures.
  Price reductions as a result of government austerity measures or other price setting action.
 Continue to work with payors, commercial or governmental, to ensure access to and coverage of our products.
  Establishment of health economic business case to justify existing pricing.
 Loss of revenue and profits.
  Hinder patient access to treatment.
 Build resilience of our franchise.
  Expand global treatment.


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.
Specific risks we may face
How we manage risk
Possible impacts
Link to Strategic Priority
 Non-compliance with anticorruption, healthcare, data privacy, or local laws could result in fines, loss of reimbursement, damage to reputation and criminal penalties.
 Failure to comply with payment and reporting obligations under the US Medicaid Drug Rebate program or other governmental pricing programs.
 Restrictions on Group's ability to sell products or product candidates in certain markets/countries due to controlled substance legislation.
  Government investigations of the Group's activities alleged to be improper.
 The Group has established a compliance program applicable to all employees.
 All employees required to complete a comprehensive compliance training program annually.
 Reviews and controls put in place over government pricing and reporting.
 Increased oversight and monitoring of controls and procedures in emerging markets.
  Continued co-operation with the authorities on on-going investigations utilizing external counsel as needed.
 Loss of revenue and profits.
 Damage to reputation.
  Fines and/or penalties.
 Build resilience of our franchise.
  Expand global treatment.
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 we may face
How we manage risk
Possible impacts
Link to Strategic Priority
 Inability to identify, acquire, close or integrate acquisition targets successfully.
 Board of Directors reviews all significant transactions.
 Internal and external resources in place
 to ensure rigorous due diligence and integration of acquisitions and/or new product initiatives.
 Adverse impact to long-term growth.
 Loss of revenue and profits.
  Damage to reputation.
 Business development.
 Expand global treatment.
  Develop our pipeline.
(ii)  RELATED PARTY TRANSACTIONS 
The following statements regarding related party transactions of Indivior are set out in the Annual Report 2014. The following is extracted in full and unedited form from the Annual Report. 
NOTE 24: RELATED PARTY TRANSACTIONS 
RB, the former parent, and RBP Global Holdings Limited (RBP), the previous holding company of the Group, entered into a Transitional Services Agreement (TSA) prior to the demerger. Pursuant to the terms of the TSA, RB is providing RBP with certain services on commercial terms and on an arm's length transaction. Services include, but are not limited to, sales and marketing services, and the provision of various back office services and support across finance, HR, regulatory, IS, office space and facilities.
Key management compensation is disclosed in Note 6a.
The principal subsidiary undertakings included in the consolidated Financial Statements at December 31, 2014 are disclosed in Note 2 to the Parent Company financial statements.
PARENT COMPANY NOTE 7: RELATED PARTY TRANSACTIONS 
The Company has taken advantage of the exemption within Financial Reporting Standard No. 8 'Related Party Disclosures' not to disclose related party transactions with wholly owned subsidiaries of the Group. There were no other related party transactions (2013: not applicable).
(ii) DIRECTORS' RESPONSBILITY STATEMENT 
The Directors consider that the Annual Report and Financial Statements 2014, taken as a whole, is fair, balanced and understandable and provides the information necessary for Shareholders to assess a company's performance, business model and strategy. 
Each of the Directors, whose names and functions are listed below, confirms that, to the best of his or her knowledge: 
 The Group financial statements, which have been prepared in accordance with IFRSs as adopted by the EU and IFRSs as issued by the IASB, give a true and fair view of the assets. liabilities, financial position and profit of the Group; and 
 The Report of the Directors includes a fair review of the development and performance of the business and the position of the Group, together with a description of the principal risks and uncertainties that it faces. 
Name 
Function
Howard Pien 
Chairman
Shaun Thaxter 
Chief Executive Officer 
Cary Claiborne 
Chief Financial Officer 
Rupert Bondy 
Senior Independent Director 
Yvonne Greenstreet 
Independent Non-Executive Director
Adrian Hennah
Non-Executive Director
Thomas McLellan
Independent Non-Executive Director
Lorna Parker
Independent Non-Executive Director
Daniel Phelan
Independent Non-Executive Director
Christian Schade 
Independent Non-Executive Director
Daniel Tass
Independent Non-Executive Director

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