Risks and opportunities are inherent to entrepreneurial activity. We have put systems and processes in place to identify risks at an early stage and to counteract them by taking appropriate action. Within the company, opportunity management is an integral component of internal decision-making processes such as short- and medium-term operational planning and intra-year business plans.
Merck is part of a complex, global business world and is there fore exposed to a multitude of external and internal influences. Every business decision is therefore based on the associated risks and opportunities.
In our internal risk reporting, risks are defined as possible future events or developments that could lead to a negative deviation from our (financial) targets. In parallel, opportunities are defined as possible events or developments that imply a positive deviation from our planned (financial) targets. Identified future events and expected developments are taken into account in internal planning provided that it can be assumed that their occurrence is likely in the planning period. The risks and opportunities presented in the following risk and opportunities report are those possible future events that could respectively lead to a negative or positive deviation from the topics covered by planning.
The objective of our risk management activities is to recognize, assess and manage risks early on and to implement appropriate measures to minimize them. The responsibilities, objectives and processes of risk management are described in our internal risk management guidelines. The business heads, managing directors of Merck subsidiaries, and the heads of Group functions are specified as employees with responsibility for risks. The group of consolidated companies for risk reporting purposes is the same as the group of consolidated companies for the consolidated financial statements. Every six months, the risk owners assess their risk status and report their risk portfolio to Risk Management. We use special risk management software in the context of these activities.
If risk-mitigating measures can be taken, their impact on risk is also assessed. The residual risk after the implementation of mitigation measures is presented in the internal risk report as net risk. The planned timeframe for implementation and the assumed mitigation effect are tracked by Group Risk Management.
Group Controlling & Risk Management forms the organizational framework for risk management and reports directly to the Group Chief Financial Officer. Group Risk Management uses the information reported to determine the current risk portfolio for the Merck Group, presenting this in a report to the Executive Board, the Supervisory Board and the Finance Committee with detailed explanations twice per year. Furthermore, significant changes in the assessment of the risks already known and new significant risks can be reported at any time and are communicated to the corporate bodies on an ad hoc basis.
In the standard process a lower limit for reporting risks is set at a value of € 5 million and for the ad hoc process at a value of € 25 million. Risks below these limits are steered independently within the business sectors. The relevant timeframe for internal risk reporting is five years. The effects of risks described in this report on risks and opportunities are presented as annual values. The assessment of the risks presented relates to December 31, 2015. There were no relevant changes after the end of the reporting period that would have necessitated an amended presentation of the risk situation of the Group.
Within the scope of audits, Group Internal Auditing regularly reviews the performance of risk management processes within the units and, at the same time, the communication of relevant risks from the operating businesses to Group Risk Management.
The risk management system described concentrates on business risks, and not on opportunities at the same time. The opportunity management process is integrated into our internal controlling processes and carried out in the operating units on the basis of the Group strategy. The businesses analyze and assess potential market opportunities as part of strategy and planning processes. In this connection, investment opportunities are examined and prioritized primarily in terms of their potential value proposition in order to ensure an effective allocation of resources. We selectively invest in growth markets to leverage the opportunities of dynamic development and customer proximity at a local level.
If the occurrence of the identified opportunities is rated as likely, they are incorporated into the business plans and the short-term forecasts. Trends going beyond this or events that could lead to a positive development in the net assets, financial position and results of operations are presented in the following report as opportunities. These could have a positive effect on our medium-term prospects and lead to a positive deviation from forecasts.
The significance of risks is calculated on the basis of their possible negative impact on the forecast financial targets in conjunction with the probability of occurrence of the respective risk. In line with these two factors, risks are classified as ”high”, ”medium” or ”low”.
The underlying scales for measuring these factors are shown below:
|Probability of occurrence||Explanation|
|20 – 50%||Possible|
|51 – 80%||Likely|
|> 80%||Very likely|
|Degree of impact||Explanation|
|> € 50 million||Critical negative impact on the net assets, financial position and results of operations|
|€ 20–50 million||Substantial negative impact on the net assets, financial position and results of operations|
|€ 5 – < 20 million||Moderate negative impact on the net assets, financial position and results of operations|
|< € 5 million||Immaterial negative impact on the net assets, financial position and results of operations|
The combination of the two factors results in the risk matrix below, which shows the individual risks and their significance to the Group.
Opportunities are assessed in their respective specific business environment. Marketing measures for operational planning are usually quantified in relation to sales, EBITDA pre exceptionals and business free cash flow. Net present value, internal rate of return, the return on capital employed (ROCE), and the amortization period of the investment are primarily used to assess and prioritize investment opportunities. Similarly, scenarios are frequently set up to simulate the influence of possible fluctuations and changes in the respective factors on results. There is no overarching, systematic classification of the probability of occurrence and impact of opportunities.
The objective of the internal control system for the accounting process is to implement controls that provide assurance that the financial statements are prepared in compliance with the relevant accounting laws and standards. It covers measures designed to ensure the complete, correct and timely conveyance and presentation of information that is relevant for the preparation of the consolidated financial statements and the management report.
The internal control system is geared to ensuring the accuracy of the consolidated accounting process and the implementation of internal controls for the preparation of compliant financial statements with reasonable assurance. The Group Accounting function centrally steers the preparation of the consolidated financial statements of Merck KGaA as the parent company of the Merck Group. This Group function defines the reporting requirements that the Merck subsidiaries must meet as a minimum requirement. At the same time, this function steers and monitors the scheduling and process-related requirements of the consolidated financial statements. Group-wide accounting guidelines form the basis for the preparation of the statutory financial statements of the parent company and of the subsidiaries, which are reported to Group Accounting; the guidelines are adapted in a timely manner to reflect changes in the financial regulatory environment and are updated in accordance with internal reporting requirements. Intra-group transactions are eliminated during the consolidation process. This gives rise to the need for a mirrored entry at the corresponding subsidiaries that is monitored during the consolidation process.
Group Accounting also ensures the timely central management of changes to the equity holding structure and correspondingly adapts the Group’s scope of consolidation. The individual companies have a local internal control system. Where financial processes are handled by a Shared Service Center, the internal control system of the Shared Service Center is additionally applied. Both ensure that accounting complies with IFRS (International Financial Reporting Standards) and with the Group accounting guidelines.
Group Accounting provides support to the local contacts and ensures a consistently high quality of reporting throughout the entire reporting process.
The accounting process is designed at all levels to ensure a clearly defined segregation of duties and assignment of responsibilities to the units involved in the accounting process at all times within the scope of dual control.
For the assessment of balance sheet items, Group Accounting closely cooperates with Group Risk Management in order to correctly present potential balance sheet risks. For special issues, such as the measurement of intangible assets within the scope of company acquisitions or pension obligations, external experts are additionally involved where necessary. For the Group accounting process, we use a standard SAP software tool in most countries. Via a detailed authorization concept to limit user rights on a need-to-have basis, and in line with the principles of the separation of duties, the system contains both single-entity reporting and the consolidated financial statements.
The effectiveness of Merck’s internal control system with regard to accounting and the compliance of financial reporting by the individual companies is confirmed by both the local managing director and the local chief financial officer when they sign the single-entity reporting. All the structures and processes described are subject to regular review by Group Internal Auditing based on an annual audit plan set out by the Executive Board. The results of these audits are dealt with by the Executive Board, the Supervisory Board and the Finance Committee.
The internal control system at Merck makes it possible to lower the risk of material misstatements in accounting to a minimum. However, no internal control system – regardless of its design – can entirely rule out a residual risk.
As a global company, we face political and regulatory changes in a large number of countries and markets.
In the Healthcare business sector, the known trend towards increasingly restrictive requirements in terms of drug pricing, reimbursement and approval is continuing. These requirements can negatively influence the profitability of our products, also through market referencing between countries, and jeopardize the success of market launches and new approvals. Close communication with health and regulatory authorities serves as a preventive measure to avert risks. The effects of corresponding risks are taken into account as best possible in the business sector’s plans.
Likewise, in our Life Science and Performance Materials business sectors, we must adhere to a multitude of regulatory specifications regarding the manufacture, testing and marketing of many of our products. Specifically in the European Union, we are subject to the European chemicals regulation REACH. It demands comprehensive tests for chemical products. Moreover, the use of chemicals in production could be restricted, which would make it impossible to continue manufacturing certain products. We are constantly pursuing research and development in substance characterization and the possible substitution of critical substances so as to reduce the occurrence of this risk, and therefore view it as unlikely. Nevertheless, it is classified as a medium risk given its critical negative impact on the net assets, financial position and results of operations.
The destabilization of political systems as for example in Ukraine and the Middle East and the possible establishment of trade barriers as well as foreign exchange policy changes can lead to declines in sales in certain countries and regions. Diversification in terms of products, industries and regions enables the mitigation of potential negative effects. The effects of corresponding risks are taken into account to the best of ability in the business plans for the countries and regions concerned. In particular, our business can furthermore be affected by macroeconomic developments in, for example, Venezuela, Argentina, Brazil, Russia, and Greece. Corresponding sales strategy measures have been introduced in these countries to minimize the impact on business. Nevertheless, the remaining possible net risk could have critical negative effects on the net assets, financial position and results of operations and therefore we rate this as a medium risk.
Merck competes with numerous companies in the pharmaceutical, chemical and life science sectors. Rising competitive pressure can have a significant impact on the quantities sold and prices attainable for our products.
Over the past three and a half years, we have moved forward with the development of our own Biosimilars business with a focus on the therapeutic areas of oncology and autoimmune diseases. Apart from the development of our own active ingredients, we entered into a partnership with Dr. Reddy’s Laboratories Ltd., Hyderabad, India, among others, to co-develop a portfolio of biosimilars in oncology. Moreover, in 2014 we established a partnership in the Brazilian market with Bionovis SA, Barueri, Brazil to develop a portfolio of biosimilars. Significant contributions to sales by the Biosimilars business unit are not to be expected before the medium to long term. However, the expenditure required for the development of this business unit has already been taken into account in today’s planning.
We see opportunities in the medium- to long-term possibilities of significant market growth of OLED applications in high-quality display applications. We are building on more than ten years of experience in manufacturing organic light-emitting diode (OLED) materials as well as a strong portfolio of worldwide patents in order to develop ultrapure and extremely stable materials that are precisely tailored to customer requirements. The development in the OLED market is being driven by the diversification of applications for OLED displays. OLED technology is an established alternative to LCDs in small-area displays, for instance smartphones. However, owing to technological advances, OLED technology is increasingly being used in more and more large-area displays, such as televisions. High-quality lighting applications, for example for automobiles, offer further growth potential for OLEDs. In order to make the mass production of large-area OLED displays more efficient, we have been cooperating since the end of 2012 with Seiko Epson Corporation to enable printing processes for OLED displays. To support the expected market growth, we are investing around € 30 million in a new OLED production unit at the Darmstadt site, where we will start manufacturing ultra-high-purity OLED materials for applications in modern displays and lighting systems as of summer 2016. We made a further investment of around € 7 million to construct a new OLED Application Center (OAC) in Korea, which was inaugurated in May 2015. With the OAC, we are securing competitive advantages since it enables us to better meet the needs of Korean customers and to correspondingly shorten the time to market launch.
Moreover, within the framework of partnerships with display manufacturers, start-ups and universities, progress has been made in the realization of shapeable displays. Through the application of flexible organic electronics, an entirely glass-free plastic LC display that is both bendable and extremely robust has been developed.
Lastly, we fully acquired the Israeli company Qlight Nanotech Ltd., Tel Aviv, Israel in order to actively support technological advances in the display industry. This move is expected to strengthen the further development of quantum materials for display applications.
We are pursuing a strategy of leveraging our expertise as the global market leader in liquid crystals in order to develop new fields of application for innovative liquid crystal technologies, e.g. liquid crystal windows (LCWs), mobile antennas or liquid crystal displays (LCDs). With the acquisition of our long-standing cooperation partner Peer+ B.V., we are further advancing the development of the future-oriented market for LCWs. Thanks to licrivision™ technology, LCWs create new architectural possibilities. Through progressive brightness control, they can for example increase a building’s energy efficiency.
Antennas that can receive signals transmitted in the high frequency range (e.g. Ka and Ku band) can also be realized with the aid of corresponding liquid crystal mixtures. As a result, mobile data exchange could improve significantly in a wide variety of fields of application. Since novel liquid crystal materials for antennas are currently being developed, the market launch of liquid crystal antennas could still take a few years. New application opportunities for liquid crystals could have medium- to long-term positive effects on the financial indicators of the Performance Materials business sector.
In October 2015, we announced that we had relaunched our branding and in this context presented our new visual appearance and new logo to the public. Our new branding reflects our transformation into a science and technology company while at the same time ensuring that we operate uniformly as Merck worldwide, with the exception of the United States and Canada.
Through this step, we will be uniformly and widely visible. Due to the higher recognition and the brand strengthening we are aiming for, potential new business opportunities could arise. Moreover, stronger customer ties could have positive effects on our business and financial results. However, since the new brand must first be established, the effects on our business will only be possible in the medium to long term.
With the acquisition of Sigma-Aldrich we have gained access to the leading life science e-commerce platform. Our customers are already benefiting from an offering of more than 300,000 products including highly respected brands distributed via this e-commerce platform. Our goal is to expand this platform and to continuously increase the number of products available on it. Making ordering processes faster and more convenient for our customers could lead to higher sales volumes and enable us to reach new customers. If this opportunity materializes, our net sales could increase faster than expected.
In the Healthcare business sector, both our biopharmaceutical products and classic pharmaceutical business are exposed to increased competition from rival products (in the form of biosimilars and generics). In the Life Science and Performance Materials business sectors, risks are posed not only by cyclical business fluctuations but also, particularly with respect to liquid crystals, by changes in the technologies used or customer sourcing strategies. We use close customer relationships and in-house further developments as well as precise market analyses as mitigating measures. Overall, owing to its possible occurrence with a critical negative impact, the market risk is classified as a medium risk.
For us, innovation is a major element of the Group strategy. Research and development projects can experience delays, expected budgets can be exceeded, or targets can remain unmet. Research and development activities are of special importance to the Healthcare business sector. In the course of portfolio management, we regularly evaluate and, if necessary, refocus research areas and all R&D pipeline projects.
Special mention should be made of the strategic alliance formed in 2014 between our company and Pfizer Inc. as a research and development opportunity in the Healthcare business sector. By making the required investments jointly and combining their strengths and expertise, Pfizer and we will maximize the potential value of the research compound MSB 0010718C, an anti-PD-L1 antibody that we developed. Owing to the relatively long cycles in active ingredient development, we expect that positive effects of this alliance will be reflected in the sales and profitability of the Healthcare business sector in the medium to long term. By contrast, expenses currently being incurred particularly in the research and development units of our Healthcare business sector are already reflected in the latest plans. The same applies to the pro rata recognition of deferred income from Pfizer’s upfront payment.
Sometimes development projects are discontinued after high levels of investment at a late phase of clinical development. Decisions – such as those relating to the transition to the next clinical phase – are taken with a view to minimizing risk. Furthermore, there is the risk that the regulatory authorities either do not grant or delay approval, which can have an impact on earnings. Additionally, there is the danger that undesirable side effects of a pharmaceutical product could remain undetected until after approval or registration, which could result in a restriction of approval or withdrawal from the market. We are currently not aware of any risks beyond general development risks that could significantly affect the net assets, financial position and results of operations.
We are required to comply with the highest standards of quality in the manufacture of pharmaceutical products (Good Manufacturing Practice). In this regard we are subject to the supervision of the regulatory authorities. Conditions imposed by national regulatory authorities could result in a temporary ban on products/production facilities, and possibly affect new registrations with the respective authority. We take the utmost effort to ensure compliance with regulations, regularly perform our own internal inspections and also carry out external audits. Thanks to these quality assurance processes, the occurrence of a risk is unlikely, however cannot be entirely ruled out. Depending on the product concerned and the severity of the objection, such a risk can have a critical negative impact on the net assets, financial position and results of operations. Therefore, we rate this as a medium risk.
Quality controls along the entire value chain reduce the risks related to product quality and availability. This starts with the qualification of our suppliers. Quality controls also include comprehensive quality requirements for raw materials, purchased semi-finished products and plants. We are dependent on individual suppliers of precursor products for some of our main products. In the event that one of these suppliers curtails or discontinues production, or supply is disrupted, this could potentially have a critical impact on the business concerned. With long-term strategic alliances for precursor products critical to supply and price as well as alternative sourcing strategies, we reduce the probability of occurrence of these risks and rate them as unlikely. Overall, these are classified as medium risks.
Further risks include the risk of operational failures due to force majeure, for example natural disasters such as floods or earthquakes, which could lead to a substantial interruption or restriction of business activities. Insofar as it is possible and economical to do so, the Group limits its damage risks with insurance coverage, the nature and extent of which is constantly adapted to current requirements. Although the occurrence of these risks is considered unlikely, an individual event could have a critical negative effect on the net assets, financial position and results of operations and is therefore classified as a medium risk.
Companies in the chemical and pharmaceutical industries are exposed to product liability risks in particular. Product liability risks can lead to considerable claims for damages and costs to avert damages. We have taken out the liability insurance that is standard in the industry for such risks. However, it could be that the insurance coverage available is insufficient for individual cases. Although the occurrence of product liability claims in excess of the existing insurance coverage is considered unlikely, individual cases could still have a critical negative effect on the net assets, financial position and results of operations. We therefore rate a potential product liability risk as a medium risk.
Owing to our portfolio, we are exposed to a number of sector-specific crime risks. This relates primarily to products, including among other things, counterfeiting, illegal channeling, misuse as well as all types of property crime, including attempts at these crimes. Crime phenomena such as cybercrime and espionage could equally affect our innovations or innovation abilities as such.
To combat product-related crime, an internal coordination network covering all functions and businesses (”Merck Anti-Counterfeiting Operational Network”) was set up several years ago. In addition, security measures are in use to protect products against counterfeiting. Innovative technical security solutions and defined preventive approaches are used to ward off dangers relating to cybercrime and espionage. Measures to prevent risks and to prosecute identified offenses are conducted in all the relevant crime areas in close and trustworthy cooperation with the responsible authorities.
The impact of these risks on business operations depends on the respective individual case, product-specific factors, the value chain, as well as on regional aspects in particular. Group Security is responsible for the overall coordination of all measures in this area. Overall, the threat resulting from crime in general is seen as being possible and is classified as a medium risk.
We continue to assume that in the coming years, the markets of Asia, the Middle East, Latin America, and Africa will be of above-average importance to the growth of all the business sectors. In order to further use this potential for our businesses, we have moved forward with several investment projects in recent years. These include for example the construction of our new OLED Application Center in Korea and a new production facility for liquid crystals as well as the establishment of a new Biopharma site in China. Moreover, we are strengthening our activities in Africa through strategic investments as well as geographic expansion in selected regions. The greater local presence and customer proximity could give us a key competitive edge and, in the medium to long term, offers the opportunity for significant growth in sales and EBITDA pre exceptionals.
As a corporate group that operates internationally and due to our presence in the capital market, we are exposed to various financial risks and opportunities. Above all, these are liquidity and counterparty risks, financial market risks and opportunities, risks of fluctuations in the market values of operational tangible and intangible assets, as well as risks and opportunities from pension obligations.
In the area of financial risks and opportunities, we use an active management strategy to reduce the effects of fluctuations in exchange and interest rates. The management of financial risks and opportunities by using derivatives in particular is regulated by extensive guidelines. Speculation is prohibited. Derivative transactions are subject to constant risk controls. A strict separation of functions between trading, settlement and control functions is ensured.
In order to ensure its continued existence, a company must be able to fulfill its commitments from operating and financial activities at all times. We therefore have a central Group-wide liquidity management process to reduce potential liquidity risks. Furthermore, we have a multi-currency revolving credit facility of € 2 billion with a term of five years, which ensures continuing solvency if any liquidity bottlenecks occur. As our loan agreements do not contain any financial covenants, these agreed lines of credit can be accessed even if Merck’s credit rating should deteriorate. Additionally, we have a commercial paper program with a maximum volume of € 2 billion as well as a debt issuance program that forms the contractual basis for the issue of bonds with a maximum volume of € 15 billion.
The acquisition of Sigma-Aldrich (US$ 17 billion) was financed by cash on hand, diverse euro and U.S. dollar bonds, as well as various bilateral loans and a syndicated credit line with a bank consortium. The financing instruments are to be successively repaid in the coming years. Overall, the liquidity risk is rated as low.
Counterparty risks arise from the potential default by a partner in connection with financial investments, loans and financing commitments on the one hand and receivables in operating business on the other.
As for counterparty risks from financial transactions, we review all positions relating to trading partners and their credit ratings on a daily basis. We manage financial risks of default by diversifying our financial positions and through the related active management of our trading partners. Significant financial transactions involving credit risk are entered into with banks and industrial companies that have a good credit rating. Moreover, our large banking syndicate – the multi-currency revolving credit facility of € 2 billion was syndicated by 19 banks – reduces possible losses in the event of default.
The solvency and operational development of trading partners is regularly reviewed as part of the management of operational counterparty risks. Sovereign risks are also analyzed. The volume of receivables of each customer is capped in line with their credit ratings. Risk-mitigating measures, such as credit insurance, are utilized as appropriate. Nevertheless, defaults by isolated trading partners, even those with outstanding credit ratings, cannot be entirely ruled out, although rated as unlikely (further information can be found in ”Credit risks” under ”Management of financial risks” in the Notes to the Group accounts).
Counterparty risk is classified as a medium risk overall owing to the unlikely probability of occurrence with a potential critical negative effect.
As a result of our international business activities and global corporate structure, we are exposed to risks and opportunities from fluctuations in exchange rates. These result from financial transactions, operating receivables and liabilities, as well as forecast future cash flows from sales and costs in foreign currency. We use derivatives to manage and reduce the aforementioned risks and opportunities (further information can be found in ”Derivative financial instruments” in the Notes to the Group accounts). Due to their possible occurrence with a potentially critical negative effect on the net assets, financial position and results of operations, foreign exchange rate risks are rated as medium risk.
Future refinancing and cash investments are exposed to the risks and opportunities of interest rate fluctuations. These are also managed and reduced using derivatives. Following the issue of multiple fixed-interest financing instruments within the context of the Sigma-Aldrich acquisition, interest rate risks have declined. They have a potentially moderate negative impact, are considered unlikely and pose low risks overall.
The carrying amounts of individual balance sheet items are subject to the risk of changing market and business conditions and thus to changes in fair values as well. Necessary impairments could have a significant negative non-cash impact on earnings and affect the accounting ratios. This applies in particular to the high level of intangible assets including goodwill, which mainly derive from the purchase price allocations made in connection with past acquisitions (further information can be found under ”Intangible assets” in the Notes to the Group accounts). All relevant risks were assessed during the preparation of the consolidated financial statements and taken into account accordingly. We rate risks beyond this as low.
We have commitments in connection with pension obligations. The present value of defined benefit obligations can be significantly increased or reduced by changes in the relevant valuation parameters, for example the interest rate or future salary increases. Pension obligations are regularly assessed as part of annual actuarial reports. Some of these obligations are covered by the pension provisions reported in the balance sheet, while other obligations are funded by plan assets (further information can be found under ”Provisions for pensions and other post-employment benefits” in the Notes to the Group accounts). To the extent that pension obligations are covered by plan assets consisting of interest-bearing securities, shares, real estate, and other financial assets, decreasing or negative returns on these assets can adversely affect the fair value of plan assets and thus result in further additions to pension provisions. By contrast, rising returns increase the value of plan assets, thereby resulting in excess cover of plan liabilities. We increase the opportunities of fluctuations in the market value of plan assets on the one hand and reduce the risks on the other by using a diversified investment strategy. The possible risk due to pension obligations could have a moderate negative impact on the net assets, financial position and results of operations, and is classified as a medium risk.
The capital market uses the assessments published by rating agencies to help lenders assess the risks of a financial instrument. We are currently rated by the agencies Standard & Poor’s and Moody’s. While Standard & Poor’s issued a long-term rating of A with a negative outlook, Moody’s issued a Baa1 rating with a negative outlook. The latest drop in the Moody’s rating by one grade in 2014 as well as the negative outlook of both rating agencies is due to the higher debt level following the Sigma-Aldrich transaction. In line with market procedures, our financing conditions are closely tied to our rating. The better a rating, the more favorably we can generally raise funds on the capital market or from banks.
Generally, we strive to minimize and control our legal risks. To this end, we have taken the necessary precautions to identify threats and defend our rights where necessary.
Nevertheless, we are still exposed to litigation risks or legal proceedings. In particular, these include risks in the areas of product liability, competition and antitrust law, pharmaceutical law, patent law, tax law, and environmental protection. As a research-based company, we have a valuable portfolio of industrial property rights, patents and brands that could become the target of attacks and infringements. The outcome of future proceedings or those currently pending is difficult to foresee. Generally, due to long statutes of limitations or in some cases the absence thereof, it is not possible to rule out that we will face third-party claims arising from the same issue despite the conclusion of legal proceedings. Court or official rulings or settlements can lead to expenses with a significant impact on our business and earnings.
Tax risks are reviewed regularly and systematically by Group Tax. Corresponding standards and guidelines are used in order to identify tax risks at an early stage as well as to review, evaluate and correspondingly minimize them. Risk reduction measures are coordinated by Group Tax together with the subsidiaries abroad.
In our opinion, the lawsuits described below constitute the most significant legal risks. This should not be seen as an exhaustive list of all legal disputes currently ongoing.
We are involved in a patent dispute in the United States with Biogen IDEC Inc. (Massachusetts, USA) (”Biogen”). Biogen claims that the sale of Rebif® in the United States infringes on a Biogen patent. The disputed patent was granted to Biogen in 2009 in the United States. Subsequently, Biogen sued Merck and other pharmaceutical companies for infringement of this patent. Merck defended itself against all allegations and brought a countersuit claiming that the patent was invalid and not infringed on by our actions. A Markman hearing took place in January 2012, however a decision has not yet been announced. The parties are currently engaged in court-ordered mediation proceedings that have not yet officially ended. It is currently not clear when a first-instance decision will be made. We have taken appropriate accounting measures. Given the potential critical negative effects of the legal dispute on the financial position in the event of a negative decision, we nevertheless classify this as a high risk.
In the Performance Materials business sector we have negotiated with a competitor regarding potential patent infringements. We maintain that the competitor’s patent infringement assertion is invalid owing to relevant prior art and have filed the corresponding nullity actions. The competitor has meanwhile filed two patent infringement lawsuits. We are prepared for a confrontation in this issue and have taken appropriate measures. Nevertheless, a potentially critical negative impact on the financial position cannot be ruled out.
Raptiva®: In December 2011, the federal state of São Paulo sued us for damages because of alleged collusion between various pharmaceutical companies and an association of patients suffering from psoriasis and vitiligo. This collusion is alleged to have been intended to increase sales of the medicines from the companies involved to the detriment of patients and state coffers. Moreover, patients are also suing for damages in connection with the product Raptiva®. We have taken appropriate accounting measures for these issues. Risks in excess of this with a substantial negative effect on the net assets, financial position and results of operations cannot be ruled out, but are considered unlikely. This is rated as a medium risk.
In one jurisdiction, we are subject to a government investigation regarding compliance with foreign exchange transfer restrictions. In this connection, the responsible authorities are investigating whether import prices led to impermissibly high foreign exchange transfers. Appropriate accounting measures have been taken for repayments and fines that are estimated to be probable due to the uncertain legal situation in the affected country. We classify this as a medium risk since a substantial negative impact on the financial position cannot be ruled out.
Paroxetine: In connection with the divested generics business, we are subject to antitrust investigations by the British Competition and Market Authority (CMA) in the United Kingdom. In March 2013, the authorities informed us of the assumption that a settlement agreement entered into in 2002 between Generics (UK) Ltd. and several GlaxoSmithKline companies in connection with the antidepressant drug paroxetine violates British and European competition law. Merck, the then owner of Generics (UK) Ltd., was allegedly involved in the negotiations for the settlement agreement and is therefore liable. The investigations into Generics (UK) Ltd. started in 2011, without this being known to us. On February 11, 2016, the CMA imposed a fine in this matter. We intend to take legal action against this decision and have taken appropriate accounting measures. Given the latest decision, we classify this as a medium risk with a moderate negative impact on the financial position.
Our future growth is highly dependent on our innovative strength. Therefore, the expertise and engagement of employees in all sectors in which we operate are crucial to the success of the company.
The markets relevant to the company are characterized by intensive competition for qualified specialists and by demographic challenges. Fluctuation risks specific to countries and industries have to be identified ahead of time and specifically addressed in order to keep the skills and expertise critical to success and business within the company.
Recruiting and retaining specialists and talent is therefore one of the key priorities for the company and is managed through the targeted use of, for instance, employer branding initiatives, global talent and succession management processes as well as competitive compensation packages. Nevertheless, employee-related risks that affect business activities are possible, even though their impact is difficult to assess. We rate this as a medium risk.
We use a variety of IT systems and processes in order to optimally focus and adequately support our globalization. Trends in information technology offer various opportunities but also harbor risks.
Increasing international networking and the related possibility of IT system abuse are resulting in cybercrime risks for Merck, such as the failure of central IT systems, the disclosure of confidential research and business development data, the manipulation of IT systems in chemical process control, or an increased burden or adverse impact on IT systems as a result of virus attacks. The entire Group has global security guidelines and information protection management for IT and non-IT areas, each with organizational and technical standards for access rights as well as information and data protection, based on ISO 27001.
Additionally, IT applications used globally form the basis for the contractual delivery of products and solutions. The failure of business-critical IT applications could therefore have a direct influence on our ability to deliver; likewise this applies to the failure of a data center. To achieve the required service quality, we use a quality management system certified to ISO 20000:2011. In addition, to reduce the risk of failure, we operate several redundantly designed data centers.
Despite the mitigating measures taken and functional continuity plans, the effects of cybercrime or the failure of business-critical IT applications and their influence on the net assets, financial position and results of operations are considered medium risks owing to possibly substantial impacts.
As a company with global production operations, we are exposed to risks of possible damage to people, goods and our reputation. Audits, consulting and training on environmental protection and occupational health and safety minimize these risks to people and the environment. In order to ensure the continuity of plant and equipment, we monitor these risks both at our own sites as well as at suppliers and contract manufacturers. By adhering to high technical standards, our rules of conduct and all legal requirements in environmental protection and occupational health and safety, we ensure the preservation of goods and assets. We have taken sufficient appropriate accounting measures for the environmental risks known to us. Nevertheless, we classify these as a high risk since a critical negative impact on the financial position cannot be ruled out.
Irrespective of the fact that acquisitions made in the past have been successfully completed, the risk of conducting the acquisition and integration exists for future transactions, for instance for the current integration of Sigma-Aldrich. This includes, among other things, the inability to meet sales volume targets and higher integration costs than expected, as well as the failure to meet synergy goals. The divestment of companies and businesses can lead to liability vis-à-vis the buyer, for instance through indemnity clauses and guarantee commitments. Through strong due diligence processes and closely managed integration processes, we seek to reduce the probability of occurrence of this risk. Nevertheless, owing to a possible occurrence of this risk with potentially critical negative effects on the net assets, financial position and results of operations, we classify this as a medium risk.
Although the number of risks reported is higher than the specific opportunities identified, we consider the distribution of risks and opportunities to be balanced. A balanced overall view is also supported by the fact that net sales and business success are built on a diverse range of pharmaceutical and chemical products for a variety of industries. As the markets differ in their structure and economic cycles, this diversification helps to lower risk. This diversification is being strengthened by the current acquisition of Sigma-Aldrich and the strategic alliance entered into with Pfizer in 2014.
The most significant individual risks in the businesses have been named in the report above, with business-related risks being the most significant alongside legal risks.
With respect to high and medium risks, certain changes have resulted as the assessment of the individual risks has of course altered over the fiscal year due to changing external and internal conditions, while the overall risk assessment remained stable. Thanks to the risk reduction measures taken – such as the consistent implementation of management action (organizational responsibility and process improvements), existing insurance coverage and accounting precautions – Merck’s significant risks in particular have been further minimized in net terms.
The overall view of the risk situation of the Group, which is derived from the summary of the risks described on the basis of their impact and probability of occurrence, leads to the assessment that the risks are not of a nature to threaten the existence of the Group as a going concern. We are confident that we will continue to successfully master the challenges arising from the above risks in the future as well.
In our view, business-related opportunities offer the greatest potential. An important element here is the continuous expansion in Asia, Latin America, Africa, and the Middle East. With the continuing intensification and focusing of our research and development activities, we want to be able to continue to offer our customers innovative products and help shape markets. Moreover, we also consolidate our expertise in numerous alliances, for instance with Pfizer Inc., Seiko Epson, as well as with various universities and start-ups. The topic of innovation is at the forefront of all our activities. Externally, this is becoming particularly apparent through our new Innovation Center at Group headquarters in Darmstadt, which is to develop into a nucleus of creativity at Merck. The activities listed hold significant opportunities for us in the medium to long term, beyond the underlying forecast period.
We pursue the opportunities that arise and show their expected effects in the forecast development of our key performance indicators – net sales, EBITDA pre exceptionals and business free cash flow. Furthermore, we will actively seek new opportunities, examine their implementation and drive them forward where appropriate. If opportunities arise in addition to the forecast developments, or these occur more quickly than anticipated, this could have correspondingly positive effects on our net assets, financial position and results of operations.