Risk management

As an innovative medical technology company, Nobel Biocare is exposed to various risks.

Therefore, the Group introduced a systematic risk management process in 2005. Leveraging the experience gained during the first years of systematically monitoring risks, Nobel Biocare has established comprehensive Enterprise Risk Management (ERM), which was further reshaped throughout 2011.

The risk map contains 14 key risks with more than 80 different scenarios, which were identified by analyzing the value chain, the business environment and the product life cycle, and assessed in terms of likelihood and free cash flow at risk. Furthermore the current risk controls were qualified. Risk mitigation goals and strategies, as well as operational action plans, are defined and have been put in place for all risks. Key performance and key risk indicators are also defined in order to underpin the risk assessment and the quality of related controls.

The Executive Committee (EC) as well as the Board of Directors (BoD) has periodically reviewed the key risks, which were presented by the respective risk owner.

The risk owner is accountable for a drill-down of the risk management activities on a more operational level. This includes, for example, initiation or management of action plans, definition of operational risk standards, collection of data (indicators), management or monitoring of controls and tracking of incidents.

In addition to this Group-wide approach, various operational risk management initiatives were strengthened or newly implemented during the year.

Also during 2011, the Internal Controls System (ICS) was further enhanced and training occurred across the Group. The applied methodology provides high quality controls and reduces financial reporting, fraud, and compliance risks.

In addition, Nobel Biocare has undertaken to further integrate and strengthen its overall governance, risk and compliance (GRC) activities, also by focusing Internal Audit’s activities on this topic. The Audit Committee gets a periodic update on the Group compliance roadmap.

The Head of Internal Audit, Compliance and Risk Management co-ordinates all ERM and ICS activities. In this role, he reports directly to the CEO and to the Audit Committee.

At least once a year the risk map data are reported to the Executive Committee and the Board of Directors.

The risk categories are defined as follows:

Strategy risks
This category includes new technologies, M&A activities, alliances and partnerships as well as entrance into newmarkets.
R&D risks
This category includes risks in the design of new products and potential patent infringements.
Market risks
This category comprises risks of the “idea to market” respectively the “life cycle management” process.
Operations risks
This category includes production, supply chain and IT risks, especially business and IT interruptions, quality management issues as well as IT security incidents.
Financial risks
This category covers potential financial reporting shortcomings, IFRS changes, tax, treasury as well as foreign exchange, market and interest rate risks. It also includes all operational risks related to the execution of internal and external reporting, the performance of market transactions or tax cases with high sensitivity on the consolidated IFRS group tax rate.
Human resources risks
This category includes the risk of not attracting and retaining key managers and experts or not developing them adequately. Personnel risks also include the corporate culture, especially Nobel Biocare’s attractiveness as an employer of choice and the risk of losing key team members.
Legal and compliance risks

This category comprises non-compliance with laws and regulations, as well as product liability and warranties.

The following risks and uncertainties pertain to those that are presently considered material in terms of likelihood and impact or areas in which Nobel Biocare faced material issues in 2011. General risks and uncertainties that affect companies in general are not outlined here.

Internal Controls System (ICS)

In 2011, Nobel Biocare further enhanced and improved the documentation of its Internal Controls System (ICS), which meets Swiss legal requirements and addresses the needs of a company that operates on a global scale.

The concept is based on the Committee of Sponsoring Organizations of the Treadway Commission (COSO) framework. The controls are designed to mitigate financial reporting, fraud and compliance risks across all companies of the Group, and cover a broad range of business support and core processes. In 2011, management testing of all relevant controls was performed by all subsidiaries in order to verify the operational effectiveness of this system. Focuswas also given on improving the segregation of duties concept in SAP and in finance-related processes.

The global whistleblower hotline was used as intended and managed as designed. All staff and managers have access to independent and neutral communication channels to report potential non-compliance with laws, regulations, as well as internal and external business standards. No major cases were reported. The number of cases remained almost unchanged from the previous year and is in line with international benchmarks.

All subsidiary managers and their controllers have signed a “Letter of Assurance” that covers all relevant aspects of corporate governance, compliance, risks and controls. It is a powerful tool in the effort to further strengthen the compliance culture of Nobel Biocare at the Group as well as the subsidiary level.

Investor contacts

Süha Demokan

Süha Demokan

Head of Investor Relations

Nobel Biocare Management AG  
P.O. Box
CH - 8058 Zurich-Airport
Switzerland

+41 43 211 42 30

+41 79 430 81 46

+41 43 211 42 42

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