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VEC Vectura Group Plc

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Vectura Group plc Report and Accounts for 2019 and AGM 2020 (2380K)

20/04/2020 3:06pm

UK Regulatory


Vectura (LSE:VEC)
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TIDMVEC

RNS Number : 2380K

Vectura Group plc

20 April 2020

Vectura Group plc

Report and Accounts for the year ended 31 December 2019 and Annual General Meeting 2020

Chippenham, UK - 20 April 2020 : Vectura Group plc (LSE: VEC) ("Vectura", the "Group" or the "Company") announces that today it has released the following documents:

   --    Report and Accounts for the year ended 31 December 2019 
   --    Notice of Annual General Meeting ("AGM") 2020 
   --    Form of Proxy for the AGM 

In accordance with the Listing Rule 9.6.1, a copy of these documents have been uploaded to National Storage Mechanism and will shortly be available for inspection at

https://data.fca.org.uk/#/nsm/nationalstoragemechanism.

The Board is closely monitoring the impact of Coronavirus (COVID-19) and it remains the intention of the Board to hold the AGM as planned at 10.30 a.m. on 27 May 2020. However, shareholders should note that the time, date and venue may change due to COVID-19 developments. Shareholders will not be allowed to attend the AGM in light of the COVID-19 situation and the Stay at Home measures that have been implemented by the UK government. Therefore, anyone seeking to attend the AGM will be refused entry. Shareholders are requested to submit their votes by proxy and are encouraged to do so by electronic means. Should there be any changes (including adjournment or postponement of the meeting) the Company will notify shareholders in compliance with the Company's articles of association and the Listing Rules. Please see the AGM Notice of Meeting for more information.

In compliance with DTR 6.3.5, the following information is extracted from the Report and Accounts for the year ended 31 December 2019 and should be read in conjunction with the Company's Final Results announcement issued on 17 March 2020. The documents are also available at www.vectura.com and together constitute the material required by DTR 6.3.5 to be communicated to the media in unedited full text through a Regulatory Information Service. Page and note references in the text refer to page numbers and notes contained in the Report and Accounts for the year ended 31 December 2019. This announcement is not a substitute for reading the Report and Accounts for the year ended 31 December 2019 in full.

-Ends-

Enquiries

Vectura Group plc +44 (0)1249 667700

Paul Fry - Chief Financial Officer

David Ginivan - VP Corporate Communications

Elizabeth Knowles - VP Investor Relations

John Murphy - Company Secretary

Consilium Strategic Communications +44 (0)20 3709 5700

Mary-Jane Elliott / Sue Stuart /

David Daley

ABOUT VECTURA

Vectura is a provider of innovative inhaled drug delivery solutions that enable partners to bring their medicines to patients. With differentiated proprietary technology and pharmaceutical development expertise, Vectura is one of the few companies globally with the device, formulation and development capabilities to deliver a broad range of complex inhaled therapies.

Vectura has eleven key inhaled and eleven non-inhaled products marketed by partners with global royalty streams, and a diverse partnered portfolio of drugs in clinical development. Our partners include Hikma, Novartis, Sandoz (a division of Novartis AG), Mundipharma, Kyorin, GSK, Bayer, Chiesi, Almirall, and Tianjin KingYork.

For further information, please visit Vectura's website at www.vectura.com

RISK MANAGEMENT AND INTERNAL CONTROL

Our risk management process is designed to ensure that existing or emerging significant risks are identified, assessed, managed and reported to relevant stakeholders in a timely manner to inform and support decision making. This process has been in place for the year under review and up to the date of approval of the Annual Report and Accounts.

Our process aims to mitigate the significant risks faced by Vectura in accordance with our risk appetite. As already noted in the Strategic report, the Group is transitioning its business model towards offering development services where a smaller proportion of the overall contract value is delivered through contingent milestones. This new business model is lower risk and provides for a smoother revenue profile.

It is recognised that no risk management process can provide absolute assurance against loss.

This section provides an overview of our risk management process, the key risks faced by the business, and the actions that we have taken to mitigate them. Not all the risks identified as part of our risk management processes are detailed in this section; instead we focus on those risks that the Directors believe to be the most important and which could cause Vectura's results to differ materially from expected and historical results and significantly impact our strategy. Not all of these risks are within the control of the Group and other factors besides those listed may affect the Group's performance. As with all businesses operating in a dynamic environment, some risks may not yet be known whilst other low-level risks could become material in the future.

Objectives of our risk management process:

-- to ensure that the risk appetite of the Board is embedded throughout the organisation and fully understood by those who are responsible for managing risk and making key decisions across the business;

-- to identify and assess the likelihood and potential impact of the risks that Vectura faces in the execution of its strategy and the operation of its business model, and ensure that appropriate mitigating actions and controls are in place, such that the residual risk is aligned to the risk appetite of the Board;

-- to control systematic risks within the organisation by maintaining a system of internal controls to manage risks in decision making, legal contract management, quality and regulatory processes and the processing of financial transactions; and

-- to ensure that identified risks are reported to relevant stakeholders in a timely manner to facilitate effective decision making.

The Audit Committee reviews the effectiveness of Vectura's risk management and internal control at least annually, on behalf of the Board. This review has been undertaken during the year and the Board believes that it has taken all reasonable steps to satisfy itself that the risk management process is effective and fit for purpose. No material control weaknesses or deficiencies were identified as part of this review.

Brexit

In response to the uncertainty as to the terms of the UK exiting the EU following the referendum on 23 June 2016, an internal taskforce was formed with members from the Group's Finance, Legal, Regulatory, Supply Chain and HR functions. The purpose of the taskforce was to identify risks and form risk mitigation strategies in the event of a disorderly or "hard" Brexit. Despite the UK exiting the EU on 31 January on favourable terms under the Withdrawal Agreement, the implementation period completes on 31 December 2020. Therefore, if the UK and EU fail to agree on a beneficial trading relationship by this date, or fail to extend the implementation period, then a hard Brexit will arise. Therefore, risk mitigation in the event of a "hard" Brexit is still relevant and ongoing.

Our approach to assessing risk

Risk is assessed net of the application of current control activities using a standard matrix which considers the potential likelihood of a risk event occurring and the potential impact on the business were such an event to occur. The output of this matrix allows the business to prioritise risks and mitigating actions. Risks are considered within the timeframe of at least three years, which is the same period that has been used in the Viability statement.

How our principal risks have evolved since the 2018 Annual Report

The principal risk of "Failure or delay in partnering VR647 for Phase III development" materialised in 2019. Accordingly, this risk is no longer a principal risk.

Following the shift to a CDMO business model, a new principal risk of "Failure to win new customer contracts for development services and execute these profitably" has been added. In addition, in recognition of the importance of IT to the Group and increased regulation around data privacy, a new principal risk has been added, being "Failure to protect critical and sensitive data and systems".

Our risk management framework

 
Setting the tone (R)               Designing the system (R)        Completing the review 
The Board                          Executive Leadership Team       Project managers and 
 Accountable for carrying           Responsible for ensuring        senior leaders 
 out a robust assessment            that the risk management        Responsible for updating 
 of the principal risks             and internal control systems    project and functional 
 facing Vectura, including          are appropriately designed,     risk registers and 
 those threatening its business     implemented and aligned         reporting those considered 
 model, future performance,         to the Board's risk appetite.   key to the Executive 
 solvency and liquidity.            Responsible for ensuring        Leadership Team. 
 Responsible for conducting         that the risk appetite          Responsible for implementing 
 an annual effectiveness            of the Board is appropriately   and monitoring mitigating 
 review of Vectura's risk           understood by risk owners       actions and controls. 
 management and internal            and key decision makers.        Responsible for informing 
 control systems, and the           Responsible for reviewing       project and functional 
 principal risks facing             the                             teams about risks and 
 Vectura. This review covers        business-wide and project       ensuring that mitigating 
 all material controls,             risk registers.                 actions are carried 
 including financial, operational   Responsible for conducting      out. 
 and compliance controls.           an annual assessment of 
 Responsible for reporting          its key principal risks 
 to shareholders about Vectura's    to ensure controls are 
 risk management process.           in place and, where gaps 
                                    are identified, plans 
                                    are assigned to address 
                                    them. 
                                   ------------------------------  ----------------------------- 
Review of process and outputs      -- Review of high risks         -- Risk registers 
                                   ------------------------------  ----------------------------- 
 

Our corporate goals

1 Financial accountability

2 Transform the Company into a successful CDMO

3 Drive product development and delivery management excellence

4 Quality and operational excellence

Principal risks specific to Vectura's business model - Brexit

 
Short-term supply chain disruption                              Adverse regulatory changes resulting 
 from the UK exiting the implementation                          in higher operating costs over the 
 period on 31 December 2020 without                              short, medium and longer term 
 agreeing a beneficial trading relationship 
 with the EU (a "hard" Brexit) 
Risk movement:             Corporate Goals impact:              Risk movement:              Corporate Goals impact: 
Stable                     1, 4                                 Stable                      1, 4 
-------------------------  -----------------------------------  --------------------------  --------------------------------- 
What is the risk?                                               What is the risk? 
 The Group's largest single product,                             If the UK fails to agree a beneficial 
 flutiform(R) , is manufactured in                               trading relationship before the 
 the UK and commercialised by its                                transition period ends on 31 December 
 partners in Europe, Japan and Rest                              2020, future trading with the EU 
 of World. The Group imports raw                                 and other countries may result in 
 materials into the UK and the Group's                           increased costs for Vectura, for 
 partners export flutiform(R) from                               example costs associated with the 
 the UK into overseas markets. Delays                            application of new import or export 
 to cross-border movement of goods                               tariffs. 
 could disrupt the flutiform(R) supply                           In addition, from a regulatory perspective, 
 chain.                                                          an EU legal entity is required for 
 What would the impact be?                                       medicinal product and medical device 
 Major disruption to the flutiform(R)                            submissions and clinical trials 
 supply chain could result in lost                               in the EU. Vectura also requires 
 product supply revenues and lost                                a notified body with a legal entity 
 in-market sales which generate royalties                        in the EU. A notified body conducts 
 for Vectura. If in-market sales                                 conformity assessments for European 
 are lost, patients may switch to                                directives related to medical devices. 
 alternative products and not switch                             What would the impact be? 
 back when availability returns.                                 Trading with the EU without a free 
 What could cause the risk to be                                 trade agreement could impact the 
 realised?                                                       Group as follows: 
  *    Disruption at ports of entry and exit which                *    tariffs on raw materials imported from the UK for 
       significantly slows the movement of goods such that             flutiform(R) reducing product supply margins. These 
       stocks of products in overseas markets cannot be                are incurred directly or via supplier price 
       sufficiently replenished, or imports of raw materials           increases; 
       are limited, reducing manufacturing output below 
       normal levels. 
                                                                  *    additional testing or regulatory compliance costs to 
                                                                       Vectura, which erode product supply margins; and 
  *    Alternative routings or methods of transportation are 
       unavailable. 
                                                                  *    adverse regulatory changes increase costs of 
                                                                       compliance, constraining funds for investment. 
  *    New flutiform(R) release testing capability for the 
       EU does not perform to the required level, slowing or 
       reducing the release of batches into the EU.              What could cause the risk to be 
                                                                 realised? 
                                                                 A beneficial trading relationship 
 How do we manage the risk?                                      between the UK and EU is not established 
  *    Partners have reviewed stock levels in light of           before the transition period ends 
       Brexit risks, and these have been increased where         on 31 December 2020. 
       deemed appropriate. Mitigation of these risks is          Insufficient expertise and resources 
       reviewed regularly by the Group and its partners.         are available to deal with increased 
                                                                 compliance activity. 
                                                                 How do we manage the risk? 
  *    The Group has reviewed its raw material inventory          *    The Group has sought out guidance and intelligence 
       levels and has built stocks where appropriate.                  from the relevant professional bodies and trade 
                                                                       organisations to shape its planning. 
 
  *    Vectura, partners and suppliers have engaged 
       third-party logistics providers with import and            *    The Group has established a legal entity within the 
       export expertise.                                               EU to enable it to comply with EU regulations for 
                                                                       medicinal products and devices. The Group has also 
                                                                       appointed a new EU notified body. 
  *    Alternative routings or methods of transportation 
       available to Vectura, suppliers and partners have 
       been reviewed and contingency plans developed.             *    The Group has established a capability to perform EU 
                                                                       release testing post 31 December 2020. 
 
  *    Training of internal supply chain staff on 
       import/export complexities has been undertaken.            *    Resource and training requirements have been assessed 
                                                                       and actioned accordingly. 
 
  *    Provision for flutiform(R) release testing in the EU 
       has been implemented. 
 

Principal risks specific to Vectura's business model - non-Brexit

 
Failure to win new customer contracts                           Supply chain disruption 
 for development services and execute 
 these profitably 
Risk movement:               Corporate Goals impact:            Risk movement:              Corporate Goals impact: 
New risk                     1, 2                               Stable                      1, 4 
---------------------------  ---------------------------------  --------------------------  --------------------------------- 
What is the risk?                                               What is the risk? 
 Developing a strong pipeline of                                 Vectura manages the supply chain 
 opportunities and converting these                              for certain commercial products (flutiform(R), 
 opportunities into revenues is critical                         AirFluSal(R) Forspiro(R) and Breelib(TM)) 
 to the success of the new CDMO business                         and also relies on suppliers for 
 model.                                                          the provision of quality compliant 
 In addition, Vectura must be able                               materials for R&D. 
 to deliver customer requirements                                What would the impact be? 
 profitably which requires efficient                             Major disruption to, or failure of, 
 management of development capacity                              these supply chains, particularly 
 and investment in new technologies                              for flutiform(R), could result in 
 and intellectual property.                                      lost revenues and business opportunities, 
 What would the impact be?                                       stock shortages, liabilities and 
 Vectura is unable to deliver growth                             significant damage to profitability 
 from competing in the inhaled CDMO                              and prospects for Vectura. Such disruption 
 market.                                                         could be either quality or capacity 
 What could cause the risk to be                                 related. 
 realised?                                                       What could cause the risk to be realised? 
  *    Insufficient investment in business development            *    Supply chain disruption involving a single point of 
       resources and marketing to drive presence and                   failure for which Vectura has high dependency and 
       awareness.                                                      limited resilience. 
 
 
  *    Organisation structure, processes and systems not fit      *    Supplier capacity constraints. 
       for purpose. 
 
                                                                  *    Supplier loss of licence or regulatory action 
  *    Market offering not competitive, for example: pricing,          impacting Vectura. 
       technology and delivery timelines. 
 
                                                                 How do we manage the risk? 
  *    Inefficient cost base to deliver inhaled development       *    Vectura has strong working relationships with its 
       services.                                                       suppliers; we have established due diligence 
                                                                       processes to ensure that our stringent quality 
                                                                       standards are maintained and we have put in place 
 How do we manage the risk?                                            appropriate systems that will provide an early 
  *    The recently appointed CEO brings a wealth of CDMO              warning of potential issues. 
       experience. 
 
                                                                  *    A dedicated Commercial Quality Director has oversight 
  *    The Group is recruiting experienced business                    of release of commercial product and ensures 
       development personnel in the EU and US and investing            appropriate management of quality for commercial 
       in branding and marketing.                                      products. 
 
 
  *    A technology roadmap is in place which is reviewed         *    Monthly meetings are held to discuss customer demand 
       annually. Funding for execution of the roadmap is in            forecasts and to review Vectura's ability to meet 
       place.                                                          these forecasts. Vectura has established contingency 
                                                                       arrangements to ensure that production capacities 
                                                                       exceed forecast demand so that it would be possible 
  *    A CDMO strategy implementation project is in place              to catch up on any shortfall in production or meet 
       with appropriate governance and resourcing by                   unexpected demand. Appropriate levels of safety stock 
       experienced senior leaders.                                     are maintained. 
 
 
  *    KPIs have been defined and are currently being             *    Supply chain mapping has been undertaken, and is 
       implemented to track progress on business development           regularly reviewed, to identify potential points of 
       and operational efficiency.                                     failure and mitigating actions. Where economically 
                                                                       feasible, additional sources of supply are 
                                                                       established and contracts negotiated to include 
  *    Financial targets set and finance business partners             appropriate provisions for replacement of defective 
       in place to support delivery of an efficient cost               goods. 
       base and appropriate pricing of services. 
 
                                                                  *    The Group also has appropriate insurance, but it is 
                                                                       not possible to insure against all risks and not all 
                                                                       insurable risks can be fully insured on an 
                                                                       economically feasible basis. 
 
 
Failure to launch VR315 (US) in                                 Failure of partners to deliver on 
 a competitive timeframe                                         their obligations 
Risk movement:               Corporate Goals impact:            Risk movement:             Corporate Goals impact: 
Decreasing                   1, 3                               Stable                     1, 4 
---------------------------  ---------------------------------  -------------------------  ---------------------------------- 
What is the risk?                                               What is the risk? 
 On 10 May 2017, our partner, Hikma                              Vectura earns revenues from a number 
 Pharmaceuticals PLC ("Hikma"), received                         of partnered in-market assets, most 
 a Complete Response Letter (CRL)                                notably flutiform(R), and is dependent 
 from the US FDA in relation to its                              upon these partners for maintaining 
 abbreviated new drug application                                regulatory approvals and for the 
 for its generic version of GSK's                                marketing of the products. Development 
 Advair Diskus(R). This CRL was categorised                      service revenues also depend on partners 
 as "Major".                                                     delivering on their obligations in 
 In November 2019, Hikma submitted                               order for programmes to progress 
 responses to the US FDA for review,                             to plan. 
 which includes data from a further                              Royalty revenues depend on partners 
 clinical endpoint study.                                        both to generate sales of the product 
 Vectura believes the submission                                 but also to accurately calculate 
 addresses the outstanding questions                             and pay over royalties according 
 raised by the FDA in its CRL and                                to the terms of the licence. 
 remains confident in the prospects                              What would the impact be? 
 for the approval of VR315 (US).                                 Failure of a partner to maintain 
 If VR315 (US) is approved, we are                               regulatory approvals, to comply with 
 likely to be the second generics                                relevant codes or regulations, or 
 company on the market after Mylan                               to commit an appropriate level of 
 and the third generic including                                 resource could result in loss of 
 the authorised generic distributed                              product supply revenues to Vectura. 
 by Prasco Laboratories.                                         Failure by a development partner 
 What would the impact be?                                       to deliver on their obligations during 
 The product is launched later than                              the development phase could result 
 those of competitors resulting in                               in a delay or cessation of development. 
 loss of potential future revenues                               This in turn could cause a delay 
 and funds for investment.                                       in development activities which could 
 What could cause the risk to be                                 reduce revenues. It may also delay 
 realised?                                                       the product reaching the market which 
  *    VR315 (US) not being the second generic of GSK's          could undermine the product's commercial 
       Advair Diskus(R) product.                                 potential and result in lower returns 
                                                                 on investment for Vectura. 
                                                                 The marketing, supply chain and commercialisation 
  *    Sales (volumes and/or pricing) of GSK's Advair            strategies deployed by partners for 
       Diskus(R) could decline faster than expected prior to     existing on-market products could 
       launch of VR315 (US).                                     materially impact the level of royalties 
                                                                 and sales milestones earned by Vectura. 
                                                                 What could cause the risk to be realised? 
 How do we manage the risk?                                       *    Change in partner strategy or priorities. 
  *    The Group is unable to take direct action to mitigate 
       this risk. 
                                                                  *    Partner viability or insolvency. 
 
  *    We will continue to support Hikma in responding to 
       any queries raised by the US FDA to the November 2019      *    Partner's marketing, supply chain or 
       resubmission. In addition, we will continue to                  commercialisation strategy is sub-optimal or not 
       monitor the market and progress of competitors.                 executed successfully. 
 
 
 Risk movement                                                    *    Partner failure to obtain appropriate pricing and 
 Decreasing following resubmission                                     reimbursement. 
 in November 2019 and Sandoz discontinuing 
 development of its generic version 
 in 2020.                                                         *    Partner failure to comply with relevant legislation 
                                                                       or regulations. 
 
 
                                                                  *    Partner failure to comply with the terms of a 
                                                                       licence. 
 
 
                                                                 How do we manage the risk? 
                                                                  *    All collaborations are performed under a suitable 
                                                                       legal agreement which is assessed by Vectura and its 
                                                                       legal advisors. Non-performance of these obligations 
                                                                       can result in escalation within the partner 
                                                                       organisation, or appointment of a third-party audit, 
                                                                       independent arbitration or, in extreme cases, legal 
                                                                       action. 
 
 
                                                                  *    Typically, for collaborations, a joint steering 
                                                                       committee (JSC) is established involving both Vectura 
                                                                       and partner personnel. This provides Vectura with a 
                                                                       mechanism to ensure that any joint project activity 
                                                                       is managed appropriately, and where concerns can be 
                                                                       escalated. 
 
 
                                                                  *    At a product or project level, regular operational 
                                                                       meetings take place to review progress, plans and 
                                                                       forecasts. 
 
 
                                                                  *    The Group also has a Commercial and Business 
                                                                       Development department which maintains regular 
                                                                       dialogue with existing and potential new partners. 
 
 
Failure or delay in achieving development                      Failure to develop the FOX(R) nebuliser 
 milestones required to advance the                             platforms to secure future growth 
 generic product pipeline                                       in new customer contracts 
Risk movement:              Corporate Goals impact:            Risk movement:              Corporate Goals impact: 
Stable                      1, 4                               Stable                      1, 2, 4 
--------------------------  ---------------------------------  --------------------------  --------------------------------- 
What is the risk?                                              What is the risk? 
 Failure or delay in achieving development                      The Group receives significant interest 
 milestones for the Group's generic                             in its FOX(R) nebuliser technology 
 programmes would have a material                               from existing and prospective customers. 
 adverse impact on the value of these                           The Group is also in the process 
 programmes.                                                    of closing down its German site, 
 What would the impact be?                                      where its nebuliser technology originated. 
 Termination of projects or significant                         Continuing to develop this technology 
 delays could materially affect future                          is critical to securing future growth 
 revenues, profitability and prospects                          in customer contracts as a provider 
 of Vectura.                                                    of inhalation development services. 
 What could cause the risk to be                                What would the impact be? 
 realised?                                                      Failure to be competitive versus 
  *    Manufacturing issues associated with a particular        other similar platforms, and risk 
       device or product for clinical trials.                   losing current or future revenue 
                                                                opportunities. 
                                                                What could cause the risk to be realised? 
  *    Ineffective design and execution of development           *    Failure to transfer knowledge and skills to the UK 
       activities.                                                    from the Group's German site following the 
                                                                      announcement of the German site closure in 2018. 
 
  *    Insufficient capacity or prioritisation of competing 
       projects.                                                 *    Failure to develop the platform to respond to 
                                                                      customer demands and a growing range of formulations. 
 
 How do we manage the risk? 
  *    Vectura has an established governance process to          *    Failure to maintain quality standards. 
       oversee the conduct and delivery of all development 
       programmes and to ensure that any potential changes 
       to the development plan or budget are identified and     How do we manage the risk? 
       discussed in a timely manner, such that mitigating        *    In respect of the closure of the Group's German site, 
       activities or actions can be put in place as                   transition of knowledge is progressing well. A 
       required.                                                      retention scheme is in place for key employees from 
                                                                      the closing site and resources have been recruited 
                                                                      into receiving sites in the UK. A transition team 
  *    Individuals with the necessary skills and experience           continues to exercise oversight. 
       have been recruited to lead and oversee the 
       development of our generic pipeline assets. Vectura 
       continues to work with a network of experienced           *    We work closely with our third-party suppliers to 
       consultants and contractors who provide additional             continue to improve the platform, including processes, 
       support and expertise as required.                             controls and components. These processes and controls 
                                                                      are documented, and supplier audits ensure they are 
                                                                      operated. Remediation is undertaken where issues are 
  *    Operational excellence initiatives within the                  identified. 
       development function have been and continue to be 
       implemented to maximise development capacity. 
                                                                 *    An integrated Programme team ensures all activities 
                                                                      which impact the development of the FOX(R) nebuliser 
                                                                      platform are managed cohesively. 
 

Principal risks specific to the industry in which Vectura operates

 
Changes in the regulatory, operating                           Failure to attract or retain talent/key 
 or pricing environment                                         personnel 
Risk movement:              Corporate Goals impact:            Risk movement:             Corporate Goals impact: 
Stable                      1, 2                               Stable                     3, 4 
--------------------------  ---------------------------------  -------------------------  ---------------------------------- 
What is the risk?                                              What is the risk? 
 Vectura operates in the highly regulated                       Vectura relies upon a number of key 
 international pharmaceutical industry,                         qualified management, scientific, 
 which is subject to change.                                    technical, marketing and support 
 What would the impact be?                                      personnel. Competition for such personnel 
 Changes in the pharmaceutical regulatory                       is intense and there can be no assurance 
 landscape, operational restrictions                            that the Group will be able to continue 
 and downward pricing pressure could                            to attract and retain such personnel. 
 adversely impact:                                              What would the impact be? 
  *    the number and value of customer opportunities to        The loss of talent or key personnel 
       provide development services; and                        could adversely impact the effectiveness 
                                                                of the Group's operations. 
                                                                What could cause the risk to be realised? 
  *    the value or viability of the generic pipeline            *    Inadequate succession planning and talent management. 
       products or those products already developed and 
       commercialised by partners. 
                                                                 *    Organisational disruption and/or change. 
 
 What could cause the risk to be 
 realised?                                                       *    Failure of reward and/or incentive strategy. 
  *    Political change. 
 
                                                                How do we manage the risk? 
  *    Competitor pricing strategies.                            *    Vectura seeks to develop employees for current and 
                                                                      future roles and our career development and talent 
                                                                      management programmes remain a key area of focus for 
  *    Regulatory action on pricing.                                  the Executive Leadership Team. We continue to invest 
                                                                      in ongoing training and development with leadership 
                                                                      and management development programmes in place. 
 How do we manage the risk? 
  *    Regulatory changes tend to be considered due to 
       lengthy consultations and discussions between             *    Succession plans for key roles have been developed to 
       regulators and the pharmaceutical industry. We work            ensure a talent pool is identified, developed and 
       closely with expert regulatory advisors and, when              ready for appointment. These plans include the 
       appropriate, seek advice from regulatory authorities           identification of "emergency successors" in the case 
       on the design of key development plans for                     of unanticipated and immediate absence. 
       pre-clinical and clinical programmes. 
 
                                                                 *    Vectura regularly benchmarks its reward strategy to 
  *    We work with a number of blue-chip pharmaceutical              ensure it continues to incentivise, motivate and 
       partners who have significant regulatory expertise.            retain our talented employees. This benchmarking 
                                                                      covers both short and long-term incentives. Salaries 
                                                                      of all employees are reviewed annually to ensure we 
  *    Our technology roadmap is reviewed at least annually           remain market competitive. 
       and takes account of evolving market trends, customer 
       needs and the competitive landscape. 
 
 
Failure to protect intellectual                                 Failure to protect critical and sensitive 
 property                                                        data and systems 
Risk movement:              Corporate Goals impact:             Risk movement:             Corporate Goals impact: 
Stable                      1, 2                                New risk                   4 
--------------------------  ----------------------------------  -------------------------  --------------------------------- 
What is the risk?                                               What is the risk? 
 Patent infringement by a competitor                             Data and information technology systems 
 organisation or failure to obtain                               are critical to our operations. Significant 
 patents for technology developed                                disruption to systems due to computer 
 by Vectura could impact on the value                            viruses, cyber threats, malicious 
 of Vectura's market offering as                                 intrusions or unintended or malicious 
 a CDMO and inhibit the delivery                                 behaviour by employees, contractors 
 of the generic pipeline.                                        or service providers could affect 
 What would the impact be?                                       the Group's operations. In addition, 
 Such infringement or failure could                              such disruption may compromise the 
 result in Vectura or a customer                                 integrity of information and result 
 having to take a license to third-party                         in the inappropriate disclosure of 
 IP in order to develop a product,                               confidential information, or may 
 or even being unable to commercialise                           lead to false or misleading information 
 a product, materially impacting                                 about the Group. 
 Vectura's future revenues, profitability                        The cyber security incidents that 
 and prospects.                                                  we have experienced to date have 
 What could cause the risk to be                                 not resulted in significant disruption 
 realised?                                                       to our operations. However, as the 
  *    Competitor successful in challenging Vectura or           threats evolve we cannot provide 
       partner patent.                                           assurance that our efforts in protecting 
                                                                 our systems and data will always 
                                                                 be successful. 
  *    Critical information missing from filed patent.           What would the impact be? 
                                                                 The loss of proprietary or other 
                                                                 commercially sensitive information 
 How do we manage the risk?                                      may provide competitors with a competitive 
  *    Dedicated internal resource, supplemented with            advantage resulting in competitive 
       external expertise, files for and prosecutes patents      or operational damage to the Group. 
       and other forms of intellectual property.                 The disclosure of confidential information 
                                                                 about the Group's employees, customers, 
                                                                 suppliers or other third parties 
  *    In conjunction with our partners where relevant,          could also expose the Group to liability. 
       Vectura takes steps to enforce these rights.              The potential for fraud from manipulation 
                                                                 of payment processes. 
                                                                 Failure to effectively prevent or 
  *    Third-party rights that may be of interest to and/or      respond to a major breach or cyber-attack 
       have adverse effects on Vectura's activities are also     may also subject the Group to significant 
       monitored so that action can be initiated where           reputational damage. 
       appropriate.                                              What could cause the risk to be realised? 
                                                                  *    Security vulnerability in our systems. 
 
 
                                                                  *    External cyber-criminal activity. 
 
 
                                                                  *    Employee or contractor non-maliciously introduces a 
                                                                       vulnerability which is exploited by a malicious 
                                                                       actor. 
 
 
                                                                  *    Lack of employee training around the cyber threat. 
 
 
                                                                 How do we manage the risk? 
                                                                  *    Security and access control standards in place with 
                                                                       compliance monitored. 
 
 
                                                                  *    Vectura has a dedicated security engineer who 
                                                                       provides oversight and actively monitors cyber 
                                                                       security. 
 
 
                                                                  *    Daily backup of systems and data. 
 
 
                                                                  *    Employee laptops and mobile phones are protected via 
                                                                       secure encryption. 
 
 
                                                                  *    Cyber security training provided to all employees. 
 
 
                                                                  *    Cyber risk insurance cover in place. 
 
 
                                                                  *    Ongoing programme to enhance our information and 
                                                                       system security capabilities. 
 

RELATED PARTY TRANSACTIONS

On 21 June 2019, Vectura Group plc, the parent entity, sold its investment in a subsidiary, Vectura Group Investments Limited, to a fellow subsidiary Vectura Group Services Limited. The transaction was performed at GBP147.6m book value in accordance with s845 of the Companies Act 2006 and settled one-third for cash and two-thirds for a loan receivable. On disposal of the investment in Vectura Group Investments Limited, associated Group merger reserves of GBP125.1m were released to retained earnings, one-third being considered realised and two-thirds considered unrealised until such time in the future that the debtor is repaid.

On 30 June 2019, Vectura's CEO James Ward-Lilley stepped down and left the Group. Remuneration related to his services and departure is provided in the Remuneration report.

Remuneration of key management personnel

The remuneration of the Directors, who are the key management personnel of the Group, was GBP3.0m and is set out below:

 
                                                  Year ended     Year ended 
                                                   31 December    31 December 
                                                   2019           2018 
                                                   GBPm           GBPm 
-----------------------------------------------  -------------  ------------- 
Short-term employee benefits                     1.4            0.8 
Annual incentive plan                            0.7            0.7 
Non-Executive Directors' fees                    0.6            0.5 
Post-employment benefits                         0.1            0.1 
Other                                            0.2            0.3 
-----------------------------------------------  -------------  ------------- 
Total remuneration of key management personnel   3.0            2.4 
-----------------------------------------------  -------------  ------------- 
 

Please refer to the Remuneration report for the remuneration of each Director. The Remuneration Report only includes Directors who held office in 2019.

STATEMENT OF DIRECTORS' RESPONSIBILITIES

The Directors are responsible for preparing the Annual Report and the Group and parent company financial statements in accordance with applicable law and regulations.

Company law requires the Directors to prepare Group and parent company financial statements for each financial year. Under that law they are required to prepare the Group financial statements in accordance with International Financial Reporting Standards as adopted by the European Union (IFRSs as adopted by the EU) and applicable law and have elected to prepare the parent company financial statements in accordance with UK accounting standards, including FRS 101 Reduced Disclosure Framework.

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 their profit or loss for that period. In preparing each of the Group and parent company financial statements, the Directors are required to:

   --   select suitable accounting policies and then apply them consistently; 
   --   make judgements and estimates that are reasonable, relevant, reliable and prudent; 

-- for the Group financial statements, state whether they have been prepared in accordance with IFRSs as adopted by the EU;

-- for the parent company financial statements, state whether applicable UK accounting standards have been followed, subject to any material departures disclosed and explained in the parent company financial statements;

-- assess the Group and parent company's ability to continue as a going concern, disclosing, as applicable, matters related to going concern; and

-- use the going concern basis of accounting unless they either intend to liquidate the Group or the parent company or to cease operations, or have no realistic alternative but to do so.

The Directors are responsible for keeping adequate accounting records that are sufficient to show and explain the parent company's transactions and disclose with reasonable accuracy at any time the financial position of the parent company and enable them to ensure that its financial statements comply with the Companies Act 2006. They are responsible for such internal control as they determine is necessary to enable the preparation of financial statements that are free from material misstatement, whether due to fraud or error, and have general responsibility for taking such steps as are reasonably open to them to safeguard the assets of the Group and to prevent and detect 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 corporate and financial information included on the Company's website. Legislation in the UK 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

We confirm that to the best of our knowledge:

-- the financial statements, prepared in accordance with the applicable set of accounting standards, give a true and fair view of the assets, liabilities, financial position and profit or loss of the Company and the undertakings included in the consolidation taken as a whole; and

-- the Strategic report includes a fair review of the development and performance of the business and the position of the issuer and the undertakings included in the consolidation taken as a whole, together with a description of the principal risks and uncertainties that they face.

We consider the Annual Report and Accounts, taken as a whole, is fair, balanced and understandable and provides the information necessary for shareholders to assess the Group's position and performance, business model and strategy.

Signed on behalf of the Board on 16 March 2020.

   Will Downie                                    Paul Fry 
   Chief Executive Officer                  Chief Financial Officer 
   16 March 2020                                16 March 2020 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.

END

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