REG - ConvaTec Group PLC - ConvaTec full year 2016 results <Origin Href="QuoteRef">CTEC.L</Origin> - Part 4

ConvaTecAnnouncement

02/03/2017 07:06

- Part 4: For the preceding part double click  ID:nRSB2939Yc 

                                                                                                                                                                                                                                   Response / mitigation                                                                                                                                                     
 Governmental Social Health Care Policy Risk Certain of our products, which are sold to governmental social health care services, could be negatively impacted by reductions in reimbursement spending, enhanced government audits and/or unfavourable governmental reimbursement policies.  ●   Unforeseen reductions in governmental budgets or other changes to government reimbursement policy could adversely affect the demand for our products.  ●   Failure to monitor changes in government payment policies in the countries in which we operate could result in financial losses.                                                                                                                                                                                                                                                                                                      ●   We engage with governments to encourage continued government investment in government health programmes. ●   We continually monitor governmental policy changes and   
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  reimbursement guidelines in order to anticipate and minimise the impact of any policy revisions that may affect us.                                                       
 Intellectual Property and Product Innovation Risk We are dependent on our intellectual property and our continued development of products.                                                                                                                                                  ●   Our competitors may secure intellectual property rights that disrupt our ability to compete in certain markets.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  ●   We pursue appropriate patent protection for our intellectual property developments.                                                                                   
 ●   Our proprietary intellectual property could be subject to misappropriation by a competitor, thereby reducing our  competitive advantage.                                                                                                                                                ●   We deploy internal protections against the improper dissemination of our confidential information, including IT protections and confidentiality agreements.                                                                                                                                                                                                                                                                                                                                                                                                                                      
 ●   Governmental entities may require disclosure of our intellectual property which may reduce our competitive advantage or otherwise negatively impact our strategic advantages.                                                                                                           ●   We deploy resources to limit the scope of any mandatory disclosure of our proprietary information to governmental organisations.                                                                                                                                                                                                                                                                                                                                                                                                                                                                 
                                                                                                                                                                                                                                                                                             ●   We may be subject to litigation involving our intellectual property rights which results in a negative impact to our financial condition.                                                                                                                                                                                                                                                                                                                                                                                                                                                        ●   We conduct global IP assessments prior to product launches to reduce the risk of intellectual property litigation. ●   We monitor market activity to determine whether 
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  violations of our intellectual property rights have taken place and to assess whether to assert our intellectual property rights.                                         
                                                                                                                                                                                                                                                                                             ●   Insufficient investment in R&D, or inadequate innovation, may adversely impact our ability to compete.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           ●   We continue to invest in new product launches and product development drives to cultivate an adequate product pipeline.                                               
 Regulatory Risk We operate in intensive and diverse regulatory regimes which are subject to change.                                                                                                                                                                                         ●   Regulatory approval processes could delay, or otherwise negatively impact, the marketing and sale of our products.                                                                                                                                                                                                                                                                                                                                                                                                                                                                               ●   We coordinate regulatory approvals on an on-going basis, including scheduling appropriate review periods with regulatory bodies in advance of certification           
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  requirements.                                                                                                                                                             
 ●   Failure to obtain appropriate regulatory clearances upon a change to a product may result in negative regulatory action impacting our ability to market and sell products.                                                                                                              ●   We maintain processes to ensure that all regulatory and clinical trial requirements are considered and addressed prior to the launch of a new product.                                                                                                                                                                                                                                                                                                                                                                                                                                           
 ●   We are subject to increasing regulatory scrutiny around the globe which may delay product launches or otherwise negatively disrupt our operations.                                                                                                                                      ●   Relevant employees are trained on processes related to regulatory clearances, marketing claims related to products and regulatory inspections. ●   We have implemented a process to ensure marketing collateral receives thorough and adequate review prior to launch in relevant jurisdictions.                                                                                                                                                                                                                                                                                                 
 Product Quality and Safety Risk Defects, failures or safety or quality issues associated with our products could adversely impact our results of operations or financial condition.                                                                                                         ●   Defects related to the design or manufacture of our products may impact the quality of goods sold and harm our results of operations or reputation.                                                                                                                                                                                                                                                                                                                                                                                                                                              ●   We have processes throughout each phase of product development to monitor product manufacturing and to implement timely corrective action where necessary. ●          
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Relevant employees are trained on policies and procedures related to manufacturing and adverse event handling. ●   We have processes in place for managing product        
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  complaints. ●   We maintain records for all products containing evidence of development, testing, product and process qualification and market clearance.                 
 ●   Failure to manage adverse events appropriately could result in reputational harm, regulatory enforcement and/or financial loss.                                                                                                                                                         
 ●   Defects in our products may result in recalls, safety alerts, product liability claims or negative publicity.                                                                                                                                                                           
 Ethics, Bribery and Corruption Risk Violations of anti-corruption laws could significantly impact our finances and reputation.                                                                                                                                                              ●   The health care industry is heavily scrutinised by governmental bodies around the globe and bribery, or other violations of anti-corruption laws, may result in enforcement actions that may negatively impact our financial position and reputation. ●   Enforcement actions related to bribery could result in an inability to participate in tenders or sell products to entities that are directly or indirectly reimbursed by a governmental body. ●   Violations of anti-bribery laws could result in criminal exposure for our employees and cause material disruption to our operations  ●   We maintain top down leadership of compliance initiatives through a Compliance Steering Committee that is comprised of senior leadership. ●   We operate on-going     
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  training for all employees, including an annual attestation and annual live training for customer-facing employees. ●   We operate a global risk assessment team and an   
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  annual monitoring program. ●   We perform due diligence of third parties, require training modules for distributors, audit select distributors in high risk markets and   
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  undertake internal audit reviews of relationships with certain third parties and employee adherence to our policies and procedures relating to ethics.                    
 Data Loss / Mistreatment Risk Failure to comply with privacy and data protection laws and regulations could impact our reputation.                                                                                                                                                          ●   Inadequate protections related to the transfer of data stored on internal systems may result in our loss or theft of sensitive or confidential data. ●   An intentional attack on our IT systems may cause the loss of sensitive data. ●   Failure to adhere to laws and regulations relating to the protection of patient and/or employee data may result in financial loss and/or reputational damage.                                                                                                                                                                                         ●   We operate an IT Steering Committee deployed to assess requirements and prioritisations relating to data privacy and security. ●   All relevant employees are trained 
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  on the maintenance and handling of sensitive personal data. ●   We deploy processes in relevant segments of the business to safeguard the security of employee and        
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  customer data.                                                                                                                                                            
 
 
Forward Looking Statements 
 
This Presentation includes statements that are, or may be deemed to be, "forward looking statements". These forward-looking
statements involve known and unknown risks and uncertainties, many of which are beyond the Group's control.
"Forward-looking statements" are sometimes identified by the use of forward-looking terminology, including the terms
"believes", "estimates", "aims" "anticipates", "expects", "intends", "plans", "predicts", "may", "will", "could", "shall",
"risk", "targets", forecasts", "should", "guidance", "continues", "assumes" or "positioned" or, in each case, their
negative or other variations or comparable terminology. These forward-looking statements include all matters that are not
historical facts. They appear in a number of places and include, but are not limited to, statements regarding the Group's
intentions, beliefs or current expectations concerning, amongst other things, results of operations, financial condition,
liquidity, prospects, growth, strategies and dividend policy of the Group and the industry in which it operates. 
 
By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on
circumstances that may or may not occur in the future. These statements are necessarily based upon a number of estimates
and assumptions that, while considered reasonable by the Company, are inherently subject to significant business, economic
and competitive uncertainties and contingencies. As such, no assurance can be given that such future results, including
guidance provided by the Group, will be achieved; actual events or results may differ materially as a result of risks and
uncertainties facing the Group. Such risks and uncertainties could cause actual results to vary materially from the future
results indicated, expressed, or implied in such forward-looking statements. Forward-looking statements are not guarantees
of future performance and the actual results of operations, financial condition and liquidity, and the development of the
industry in which the Group operates, may differ materially from those made in or suggested by the forward-looking
statements set out in this Presentation. Past performance of the Group cannot be relied on as a guide to future
performance. Forward-looking statements speak only as at the date of this Presentation and the Company and its directors,
officers, employees, agents, affiliates and advisers expressly disclaim any obligations or undertaking to release any
update of, or revisions to, any forward-looking statements in this Presentation. 
 
Forward calendar 
 
A copy of the Annual Report and Accounts will be made available to shareholders on 21 March 2017 either by post or online
at www.convatec.com and will be available to the general public online or on written request to the Company's registered
office at 3 Forbury Place, 23 Forbury Road, Reading, United Kingdom RG1 3JH. 
 
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