EVOTF Evotec SE (PK)

RISK FACTORS

Risks Related to Our Business and Industry

Our business is subject to the significant and increasing challenges that face the pharmaceutical and biotechnology industries, including in particular the necessity of continual innovation and industry costs.

We are an industry-leading drug discovery and development partner for the pharmaceutical and biotechnology industry. Our mission is to discover best and first-in-class medicines for a broad range of difficult to treat diseases in collaboration with our partners. To that end, we have built a comprehensive suite of fully integrated, next generation technology platforms which we believe will transform the way new drugs are discovered. By leveraging the advanced capabilities of our integrated platforms, we are able to provide solutions to our partners that enable significant improvements in the quality of new drugs while accelerating the drug discovery process and reducing the high cost of attrition often associated with traditional drug discovery processes. The industry in which we operate is highly competitive, with many players pursuing similar scientific approaches. If we do not continually offer our partners innovative and cutting-edge solutions and remain at the forefront of precision medicine, our business may be materially and adversely affected.

Moreover, our business operations are subject to challenges as a result of industry pressures. For instance, we expect the industry to continue experiencing pricing pressures due to the persistent trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes. The downward pressure on healthcare costs, particularly with regard to prescription drugs, has intensified and our partners are impacted accordingly. As our business is dependent on the continued health and growth of the pharmaceutical and biological industry, should the industry contract due to pricing pressure, our business may be materially and adversely affected.

Our business depends on our and our partners’ success in innovation and drug development, which is highly uncertain.

We seek to serve as a source of innovative drug candidates to potential partners. We are advancing a number of active discovery and early-stage development assets that we intend to license to partners for clinical development and commercialization. Some of our assets are not partnered, and if we cannot find a suitable partner or agree on acceptable terms with a partner, we may not be able to partner, or generate a return on such assets. Furthermore, the amount of our return on our investments in our pipeline assets depends on many factors, such as the degree of innovation and strength of our intellectual property position, as well as on external factors outside of our control.

For example, our ability to generate a return on our investments in our pipeline assets depends, in significant part, on our partners’ research and development priorities. The market environment, demand and competitive landscape for our individual pipeline assets might change significantly over time as certain diseases become more or less prevalent or other treatment options are demonstrated to be more safe and effective or become more readily available, thereby reducing the market opportunities for our pipeline assets in development. As a result, the commercial objectives of our partners with respect to individual assets and the financial proceeds we may receive from partnering individual assets is highly uncertain, subject to factors outside of our control and could deviate significantly from our projections.

Whether we receive milestone and royalty payments is further subject to our partners’ success with clinical trial testing. Clinical testing is expensive, complex and can take many years to complete. Its outcome is inherently uncertain, and we do not drive the development process when our partners enter the clinical trial phase. Our partners may not be able to initiate, may experience delays in, or may have to discontinue clinical trials for a variety of reasons. Our partners also may experience unforeseen events during, or as a result of, any clinical trials that they conduct that could delay or prevent successful development. Such events may include,

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among others, failure by the FDA and other regulators or review boards to authorize our partners’ clinical trials or a decision by such parties that requires our partners to suspend or terminate clinical trials, failure to reach favorable terms with prospective trial sites and prospective contract research organizations (“CROs”), and failure to demonstrate safety and efficacy in clinical trials. Our partners may need to conduct additional non-clinical studies or clinical trials or may decide to abandon product development programs altogether.

In addition to the above, our pipeline assets that our partners develop may be associated with other serious adverse events, undesirable side effects or unexpected characteristics. Moreover, if our partners elect, or are required, to delay, suspend or terminate a clinical trial of one of our pipeline assets, the commercial prospects of such pipeline asset may be harmed and our ability to earn milestone and royalty payments may be delayed or eliminated. Any of these occurrences may harm our business, financial condition, result of operations and prospects significantly.

Drug discovery and innovation is subject to significant risks and increasing challenges.

Drug discovery and innovation carries inherent risk and there is no assurance that our strategic partners will successfully develop and commercialize potential drug products. We will only realize significant returns on our pipeline assets if research and development efforts lead to milestone and royalty payments from successful clinical development and commercialization, which may not occur at all or may occur at a level that provides no attractive return on investment.

Drug discovery and development is expensive, time-consuming and subject to high failure rates. At each stage, there is a risk that trials are delayed or need to be terminated due to negative results. Typically, the earlier the stage of a program, the higher the rate of failure. However, the cost of failure tends to increase in the later stages of development. Even if we identify promising compounds for valuable targets, any resulting R&D project could experience delays or even fail, resulting in the loss of our investment and potential milestone and royalty payments, as well as potential reputational damage, loss of future customers or partnership opportunities.

We are required to make important decisions about how to optimize our allocation of resources and there is a risk we will make wrong decisions. For instance, we invest in internal research and development opportunities with the goal of bringing proprietary assets to value inflection points for partnering. Through EVOequity, we may allocate our investments, whether comprising financial resources or scientific expertise, to the development of ultimately unsuccessful projects, or to sub-optimal investments. If we do not make optimal allocation decisions, our results of operations could be materially adversely affected.

We face various performance-related risks.

We face various performance-related risks in our operating business. For example, fluctuating demand and capacity utilization as well as resource allocation among multiple sites can significantly affect our profitability. In addition, we must continually monitor, manage and calibrate these factors. Such constant assessment and adjustment has become increasingly complex as we have acquired additional research sites and extended our offerings.

In addition, we depend on certain individual large customers. Our three largest customers accounted for 30%, 30% and 24% of our total revenues in 2018, 2019 and 2020, respectively. The loss of any of these customers would have a material adverse impact on our results of operations. Furthermore, certain of our service contracts involve scientific or technical delivery risks, which can be mitigated only in part by high-quality project work. Our past success has been built, in part, on customer recognition of the quality of our work and the strength of our brand. It is therefore imperative that we maintain our strong reputation and avoid any negative impact on our brand, which could lead to a loss of customers and a reduced ability to employ the most highly skilled employees. If we do not manage these performance-related risks, our results of operations and financial position could be adversely affected.

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We cannot assure investors that we will deliver sufficient return on investment for our partners and customers in respect of results, innovation, speed and costs of research and development. If we fail to retain market acceptance our financial position and results of operations may be adversely affected.

We intend to develop and expand our company, and we may encounter difficulties in managing our development and expansion efforts, which could disrupt our operations.

Currently, we have more than 3,900 employees and, in connection with the growth and advancement of our pipeline, we expect to increase the number of employees and the scope of our operations. To manage our anticipated development and expansion, we must continue to implement and improve our managerial, operational, legal, compliance and financial systems, expand our facilities, and continue to recruit and train additional qualified personnel. Also, our management may need to divert a disproportionate amount of its attention away from its day-to-day activities and devote a substantial amount of time to managing these development activities.

We are actively developing pipeline assets in many therapeutic areas and across a wide range of diseases. We also routinely pursue new service offerings, such as our recent expansion into CRO services including, but not limited to, protocol preparation and review and regulatory preparation and submission. Successfully developing candidates for, and fully understanding the regulatory and manufacturing pathways to, all of these therapeutic areas and diseases requires a significant depth of talent and experience, resources and corporate processes in order to allow simultaneous execution across multiple areas. In case of limited resources, we may not be able to effectively manage this simultaneous execution and the expansion of our operations or recruit and train additional qualified personnel. This may result in weaknesses in our infrastructure, give rise to operational mistakes, legal or regulatory compliance failures, loss of business opportunities, loss of employees and reduced productivity among remaining employees. For example, by expansion into CRO services, we may become liable for acts or omissions made in connection with developing clinical protocols. The physical expansion of our operations may lead to significant costs and may divert financial resources from other projects. If our management is unable to effectively manage our expected development and expansion, our expenses may increase more than expected, our ability to generate or increase our revenue could be reduced and we may not be able to implement our business strategy. Our future financial performance and our ability to compete effectively will depend in part on our ability to effectively manage the future development and expansion of our company.

We may not generate a positive return on our equity investments.

Through EVOequity we have contributed to equity investments through funding and other resources to develop and potentially commercialize assets. We may continue to make similar equity investments in the future. The companies we invest in are either third-party entities or spin-outs, where we act as an operational venture capital provider. Accordingly, we have little control over development, regulatory and commercialization efforts by such companies. As a result, we are exposed both to the risks inherent in drug discovery and development and the execution capabilities of the management teams of our equity investees. We expect to enter into additional equity investments in the future, and our equity investment strategy may pose a number of risks. Such risks include, among others, that the companies we invest in may not perform or prioritize their obligations as expected, including with respect to protection of intellectual property rights, declining to pursue the development and commercialization of any product candidates even if those candidates achieve regulatory approval, opting not to continue or renew development or commercialization of programs based on clinical trial results, changes in focus or available funding, or other external factors. If our equity investments are not successful and do not result in the development and commercialization of new products, our financial position would be adversely affected.

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Our success depends on our ability to attract and retain senior management and key employees, including highly specialized scientific staff.

Our ability to compete in the highly competitive biotechnology and pharmaceutical industry depends upon our ability to identify, attract, develop, motivate, adequately compensate and retain highly qualified managerial and scientific personnel. We are highly dependent upon members of our management and qualified scientific personnel to perform research and development work and therefore are exposed to the risk that losing employees may mean the loss of critical knowledge. We may not be able to retain these employees in particular due to the competitive environment in the biotechnology industry. The loss of any of our employees’ services may adversely impact the achievement of our strategic objectives. We currently do not have “key person” insurance on any of our employees.

We also may encounter problems hiring and retaining the experienced scientific, quality-control and manufacturing personnel needed to operate our manufacturing processes and operations, which could result in delays in production or difficulties in maintaining compliance with applicable regulatory requirements. While we will train and qualify all personnel around the appropriate handling of materials, we may not be able to control for or ultimately detect intentional sabotage or negligence by any employee or contractor.

Additionally, from time to time, our employees may be affected by industrial actions or labor disputes, particularly in Europe. To the extent our employees engage in such activities, our operations may be adversely affected.

We and our partners face intense competition in the biotechnology and pharmaceutical industries.

The biotechnology and pharmaceutical industries are intensely competitive and subject to rapid and significant technological change. We face the risk that new market entrants and existing competition may try to replicate our business model or introduce a more innovative offering that renders our services less competitive or obsolete. In addition, our drug discovery and development efforts may target diseases and conditions for which there are existing therapies or therapies that are being developed by our competitors, some of which may have greater resources, larger research and development staffs and facilities, more experience in completing target identification, pre-clinical testing, and formulation, as well as greater manufacturing capabilities than we do. Further, any drug products resulting from our research and development efforts might not be able to compete successfully with others’ existing and future products.

The approval and sale of drug products is subject to extensive regulation and accordingly our ability to generate revenue from our assets is uncertain.

Research and development activities, as well as the approval and marketing of a pharmaceutical product, are subject to extensive regulation by the U.S. Food and Drug Administration (the “FDA”) and similar regulatory authorities in other regions. The approval of the relevant authorities is required before a product can be tested in humans and later sold within a given market. The regulatory approval process is intensive, costly for our partners and time-consuming, and the timing of receipt of regulatory approval is difficult to predict. Therefore, even if the clinical development of assets by our partners is successful, regulatory approval may not be received, may be restricted to certain geographical regions or indications or might later be withdrawn or significantly delayed. Any such failure to receive regulatory approval could adversely affect our ability to realize milestone and royalty revenue.

Even if any of our pipeline assets are commercialized, they may not be accepted by physicians, healthcare payors, patients or the medical community in general.

Even if our partners obtain regulatory approval for one of our pipeline assets, the asset may not gain market acceptance or prevalent usage among physicians, healthcare payors, patients and the medical

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community, which is critical to commercial success. Market acceptance of any of our pipeline assets depends on a number of factors, including:

If any of our pipeline assets are commercialized, we may not receive the expected revenue as a result of these factors leading to poor market acceptance.

COVID-19, has affected, and any similar pandemic, epidemic or outbreak of an infectious disease may materially and adversely affect, our business, financial condition, results of operations, cash flows and prospects.

The COVID-19 pandemic is continually evolving and to date has led to the implementation of various containment measures, including government imposed shelter-in-place orders, quarantines, national or regional lockdowns, travel restrictions and other public health safety measures, as well as reported adverse impacts on healthcare resources, facilities and providers across the world. In response to the spread of COVID-19, and in accordance with direction from government authorities, we have, for example, limited the number of such personnel that can be present at our facilities at any one time, mandated the usage of face masks in all Evotec facilities, implemented weekly COVID-19 task force consultations, limited the maximum numbers of people allowed in rooms at one time and requested that many of our personnel work remotely. In the event that government authorities were to further modify current restrictions, our employees conducting research and development or manufacturing activities may not be able to access our laboratory or manufacturing facilities and our core activities may be significantly limited or curtailed, possibly for an extended period of time.

As a result of the COVID-19 pandemic, we have experienced and may in the future (with COVID-19 or other similar pandemics and outbreaks) experience severe disruptions, including:

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Any of these factors could severely affect our operations. These and other factors arising from the COVID-19 pandemic could worsen in countries that are already experiencing significant levels of COVID-19 infections, could continue to spread to additional countries or could return to countries where the pandemic has been partially or previously contained and could further adversely impact our ability to conduct our business generally and have a material adverse impact on our business, financial condition, results of operations, cash flows and prospects.

We cannot predict the scope and severity of any potential business shutdowns or disruptions as a result of the COVID-19 pandemic. The extent to which the pandemic may negatively impact our consolidated operations and results of operations or those of our third-party manufacturers, suppliers, partners or customers will depend on future developments, which are highly uncertain and cannot be predicted with confidence. Such developments include the ultimate geographic spread of the disease, the duration of the pandemic, new variants of the virus that may emerge, the effectiveness, availability and rollout of vaccines, the extent of travel restrictions, additional or modified government actions, new information that may emerge concerning the severity and impact of COVID-19 and actions to contain the pandemic or treat its impact, such as social distancing, quarantines, national or regional lockdowns or business closures. Despite increasing availability of vaccinations in many jurisdictions, it is still possible that a resurgence in communal activity will result in increased cases of COVID-19, which could result in further lockdowns, closures, and interruptions to our operations.

In addition, to the extent the ongoing COVID-19 pandemic adversely affects our business and results of operations, it may also have the effect of exacerbating the impact of the other risks and uncertainties described in this “Risk Factors” section.

The United Kingdom’s withdrawal from the European Union could lead to disruptions to our UK-based operations and the free movement of our personnel which could adversely impact the market price of our ADSs and make it more difficult for us to do business.

The United Kingdom formally exited the European Union (commonly referred to as “Brexit”) on January 31, 2020. In connection with Brexit, the United Kingdom entered into the EU–UK Trade and Cooperation Agreement 2020 on December 30, 2020 and ended its transition period on December 31, 2020. The long-term effects of Brexit will depend on the current and future agreements and arrangements the United Kingdom negotiates with the European Union, including whether and to what extent it will retain access to the European Union markets. For example, following the transition period for introducing EU-UK border controls, which is expected to end in July 2021, we may experience higher administrative costs due to the complexities that may be introduced to our business as a result of Brexit. In addition, we may experience supply chain disruptions as a result of significant delays in the customs clearance and delivery and transit of goods needed to process customer orders. These delays could result in the loss of sales or even the termination of some of our contracts. Uncertainty surrounding customs clearance for goods being shipped into and from the United Kingdom may also impact our distribution and logistics related to our regular shipping of test compounds from our UK sites to our other European sites and to our international customers. We may also experience elevated costs for import and export services. Additionally, we could experience disruptions related to the free movement of persons between the United Kingdom and the EU member states which could affect our employees’ mobility resulting in increased personnel vacancies or the inability to hire and retain qualified employees.

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There will be a period of considerable uncertainty particularly in relation to United Kingdom financial and banking markets as well as in relation to the regulatory process in Europe. As a result of this uncertainty, financial markets could experience volatility which could adversely affect the market price of our ADSs. We, along with our partners, may also face new regulatory costs or requirements and challenges that could have a material adverse effect on our operations, including the potential for a delay in our research and development processes and approvals in Europe. Depending on the terms of any future agreements and arrangements negotiated with the European Union, the United Kingdom could lose the benefits of global trade agreements negotiated by the European Union on behalf of its members, which may result in increased trade barriers that could make our doing business worldwide more difficult. In addition, currency exchange rates translated in pound sterling and euro, with respect to each other, and the U.S. dollar have already been adversely affected by Brexit. Any continued foreign exchange fluctuations could cause similar fluctuations in our financial results.

Brexit and ongoing developments in the United Kingdom have created uncertainty with regard to data protection regulation in the United Kingdom and could result in the application of new data privacy and protection laws and standards to our operations in the United Kingdom and our handling of personal data of users located in the United Kingdom. The UK General Data Protection Regulation “GDPR”), effective as of January 1, 2021, and the UK Data Protection Act of 2018 (as amended on January 1, 2021) which supplements the UK GDPR, now apply to our processing of personal data in the United Kingdom and elsewhere, if the processing is of UK residents and certain other conditions are met. The European Commission has adopted an adequacy decision in favor of the United Kingdom, enabling data transfers from EU member states to the United Kingdom without additional safeguards. However, the United Kingdom adequacy decision will automatically expire in June 2025 unless the European Commission renews or extends that decision. In addition, while the United Kingdom data protection regime currently permits data transfers from the United Kingdom to the EU and other third countries covered by a European Commission adequacy decision, and currently includes a framework to permit the continued use of EU standard contractual clauses and binding corporate rules for personal data transfers from the United Kingdom to third countries, this is subject to change in the future, and any such changes could impact our ability to transfer personal data from the United Kingdom to the EU and other third countries. Additionally, Brexit and the subsequent implementation of the UK GDPR will expose us to two parallel data protection regimes, each of which potentially authorizes similar significant fines and other potentially divergent enforcement actions for certain violations.

We are subject to certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. Any violation of such laws and regulations may subject us to criminal liability and other serious consequences.

In connection with our worldwide business operations, we must comply with a broad range of legal and regulatory requirements relating to export controls, economic sanctions, anti-bribery and corruption laws, and anti-money laundering laws.

We are subject to export controls and import laws and regulations in the countries in which we conduct business. We are required to comply with export control restrictions imposed by multiple authorities, including the United Nations, U.S. Export Administration Regulations, U.S. Customs regulations, Council Regulation (EC) 428/2009 (as amended), and German export control laws.

Our entities and personnel are also subject to various economic and trade sanctions regulations, such as economic sanctions administered by the United States (including the U.S. Treasury Department’s Office of Foreign Assets Controls), the European Union, the U.K., Germany, the United Nations or any governmental institutions/agencies of any of the foregoing. These economic sanctions restrict our ability to engage in business dealings with certain countries and persons. Failure to comply with such restrictions could lead to punitive consequences, including reputational damage, which could adversely affect our business and financial condition. In addition, the EU’s, the U.S.’s, and other applicable sanctions and embargo laws and regulations vary in their application: they do not all apply to the same covered persons or prescribe the same activities, and such sanctions and embargo laws and regulations may be amended or strengthened over time.

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Our entities and personnel are also subject to various anti-corruption laws, including the U.S. Foreign Corrupt Practices Act of 1977, as amended, the U.S. domestic bribery statute contained in 18 U.S.C. § 201, the U.S. Travel Act, the USA PATRIOT Act, and other state and national anti-bribery and anti-money laundering laws in the countries in which we conduct activities, including the UK Bribery Act 2010 and the anti-corruption laws of Germany. Anti-corruption laws are interpreted broadly and generally encompass active as well as passive bribery. These laws prohibit companies and their employees (including directors), agents, contractors, and other business partners and intermediaries from directly or indirectly receiving or accepting, or directly or indirectly authorizing, promising, offering, or providing, improper payments or anything else of value, in each case in the public or private sector on a national or international level. We may engage third parties to conduct clinical trials, and/or to obtain necessary permits, licenses, patent registrations, and other regulatory approvals. We have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities, and other organizations. Our business relations with health care professionals may be subject to particular legal risks under applicable anti-bribery and corruption laws. We can be held liable for the corrupt or other illegal activities of our employees (including directors), agents, contractors, and other business partners and intermediaries, even if we do not explicitly approve of, authorize or have actual knowledge of such activities.

U.S. public companies are required to maintain records that accurately and fairly represent their transactions and have an adequate system of internal accounting controls. We maintain and continuously improve and develop internal controls, policies, procedures and training to ensure compliance by us and our directors, officers, employees, representatives, consultants, and agents with the FCPA, UK Bribery Act and other applicable anti-corruption laws and make efforts to ensure their effectiveness. However, we can make no assurance that our controls, policies and procedures, even if enhanced, have been or will be followed at all times or effectively detect and prevent all violations of the applicable laws and every instance of fraud, bribery and corruption. In many foreign countries, including countries in which we may conduct business, it may be a local custom that businesses engage in practices that are prohibited by the FCPA, U.K. Bribery Act, or other applicable laws and regulations. Any violations of the laws and regulations described above may result in substantial civil, administrative and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm, and other consequences. In addition, responding to any enforcement action or internal investigation related to alleged misconduct may result in a significant diversion of management’s attention and resources and significant defense costs and other professional fees.

Our future success depends in part on our and our partners’ ability to penetrate global markets, where we would be subject to additional regulatory burdens and other risks and uncertainties associated with international operations.

Our future success depends in part on our ability to operate internationally, which could subject us to risks and uncertainties, including:

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Failure to successfully navigate these risks and uncertainties may limit or prevent market penetration for any products that we or our partners may develop, thereby limiting their commercial potential and our revenues.

We intend to undertake future strategic acquisitions, which may pose a variety of risks that could negatively affect our operating results.

From time to time, we acquire companies, businesses and assets and make investments that complement or augment our existing business, such as our acquisition of Just-Biotherapeutics Inc. in 2019. We intend to undertake additional strategic acquisitions, however we may not realize the intended advantages of such acquisitions and investments, in particular if we are unsuccessful in ascertaining or evaluating target businesses. For instance, our assumptions may prove to be incorrect, which could cause us to fail to realize the anticipated benefits of these transactions. If we fail to realize the expected benefits from acquisitions or investments, whether as a result of unidentified risks or liabilities, integration difficulties, regulatory setbacks, litigation with current or former employees or other events, our business, results of operations and financial condition could be adversely affected (e.g. impairments on goodwill or intangible assets). Moreover, we may not be able to locate suitable acquisition or partnership opportunities.

Following an acquisition, we may not be able to successfully integrate the acquired business or operate the acquired business profitably. Integrating newly acquired businesses can be expensive and time-consuming. In addition, integration efforts often take a significant amount of time, place a significant strain on managerial, operational and financial resources, result in loss of key personnel and can prove to be more difficult or expensive than predicted. The diversion of our management’s attention and any delay or difficulties encountered in connection with any future acquisitions could result in the disruption of our on-going business or inconsistencies in standards and controls that could negatively affect our operations, including our ability to maintain third-party relationships. If we encounter difficulties integrating newly acquired assets or operations with our platform, our business and results of operations as a group may be adversely impacted. Moreover, if we invest in new modalities and technologies, we may not be successful in integrating them into our platform offerings or generating customer or partner demand for them, which could result in failure to generate a return on our investment.

The manufacture of drug products is complex. If we encounter any difficulties in production, the supply of products for clinical trials could be delayed or stopped.

At our various sites throughout Europe, the United Kingdom and the United States, we manufacture drug products for clinical use and may encounter various difficulties in production, particularly in scaling up or out, validating the production process, and assuring high reliability of the manufacturing process. These problems may include delays or breakdowns in logistics and shipping, difficulties with production costs and

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yields, difficulties obtaining necessary raw materials on favorable terms or at all, quality control, product testing, operator error, lack of availability of qualified personnel, as well as failure to comply with strictly enforced regulations. We may also experience complications or delays in the construction of our J.POD^® facilities, as well as unforeseen manufacturing issues with the J.POD^® facilities once operational.

We have limited redundancy among our manufacturing facilities, and if any of our manufacturing facilities experience difficulties, including but not limited to manufacturing, product release, shelf life, testing, storage and supply chain management or shipping, any production may be delayed or suspended until we can resume operations. In order to resolve such difficulties, we may also be required to incur significant expenditures. If we were to encounter any of these difficulties, our ability to satisfy our partners’ requirements could be jeopardized.

Furthermore, if microbial, viral or other contaminations are discovered in our laboratories or manufacturing facilities, such facilities may need to be closed for an extended period of time to investigate and remedy the contamination. We cannot assure you that any of these or other issues relating to our manufacturing operations will not occur in the future. Any delay or interruption in the supply of products for clinical trials could delay the completion of clinical trials and, depending upon the period of delay, require our partners to begin new clinical trials or terminate clinical trials completely, where Evotec may be liable for such additional expenses depending on the relevant services agreement.

Our manufacturing facilities also require certification and validation activities to demonstrate that they operate as designed. In addition, our manufacturing facilities are subject to regulatory inspections by the FDA, the national competent authorities in EU member states (including AIFA in Italy), the Medicines and Healthcare products Regulatory Agency (“MHRA”) in the UK, and other comparable regulatory authorities. If we are unable to reliably manufacture products in accordance with the legal and regulatory requirements of the relevant regulatory authorities, we may not obtain or maintain the necessary approvals. Further, our facilities may fail to pass regulatory inspections, which would cause significant delays and additional costs required to remediate any deficiencies identified by the regulatory authorities. Any of these challenges could delay completion of clinical trials, require bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay regulatory approval, impair commercialization efforts, increase our cost of goods, and have an adverse effect on our business, financial condition, results of operations and growth prospects.

Any failure, unauthorized access, security breaches, loss of data and other disruptions to our information technology systems could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability.

We collect and maintain information in digital form that is necessary to conduct our business, particularly for purposes of our EVOpanOmics, EVOpanHunter, J.DESIGN and our iPSC-based drug discovery platforms, and we are highly dependent on our information technology systems. In the ordinary course of our business, we collect, store, and transmit large amounts of confidential information, including intellectual property, proprietary business information, human samples, personal information, and data to comply with current Good Manufacturing Practice (“GMP”), similar foreign requirements and data integrity requirements. We have also outsourced elements of our information technology infrastructure, and as a result a number of third-party vendors may or could have access to confidential information. Despite the implementation of security measures and safeguards, our information technology systems and data and those of our current or future contractors and consultants are vulnerable to compromise or damage.

Our internal computer systems and those of our current and any future partners, vendors, and other contractors or consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, cybersecurity threats, war, and telecommunication and electrical failures. Furthermore, because the techniques used to obtain unauthorized access to, or to sabotage, systems change frequently and often are not recognized until launched against a target, we may be unable to anticipate these techniques or

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implement adequate preventative measures. We may also experience security breaches that remain undetected for an extended period of time. If any such material system failure, accident or security breach were to occur and cause interruptions in our operations, it could result in a material disruption of our development programs and our business operations, whether due to a loss of our trade secrets or other proprietary information or other similar disruptions. Any such breach, loss or compromise of clinical trial participant personal data, including in connection with EVOpanHunter, may also subject us to civil fines and penalties, including under the GDPR, the law of the relevant country in the EEA (“EEA Member State”), the UK GDPR and applicable state and federal data privacy laws in the United States. To the extent that any disruption or security breach were to result in a loss of, or damage to, data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur internal costs or liability, our competitive position could be harmed and the further development and commercialization of our partners’ product candidates could be delayed.

Although we take measures to protect sensitive data from unauthorized access, use or disclosure, our information technology and infrastructure may be vulnerable to attacks by hackers or viruses or breached due to employee error, malfeasance or other malicious or inadvertent disruptions. Any such breach or interruption could compromise our networks and the information stored there could be accessed by unauthorized parties, manipulated, publicly disclosed, lost or stolen. Any such access, breach or other loss of information could result in legal claims or proceedings, and liability under federal, state or foreign laws that protect the privacy of personal information, as well as regulatory penalties. In the United States and elsewhere, notice of certain breaches must be made to affected individuals and governmental agencies, including U.S. state Attorneys General. Similarly, breach reporting obligations vis-à-vis affected individuals and data protection authorities exist under the GDPR and UK GDPR. Such a notice could harm our reputation and our ability to compete in our industry. Further, U.S. state Attorneys General are authorized to bring civil actions seeking either injunctions or damages in response to violations that threaten the privacy of state residents; affected individuals in the EEA or UK may bring similar claims in civil actions.

Unauthorized access, loss or dissemination could also damage our reputation or disrupt our operations, including our ability to conduct our analyses, deliver test results, process claims and appeals, provide customer assistance, conduct research and development activities, collect, process and prepare company financial information, provide information about our tests and other patient and physician education and outreach efforts through our website, and manage the administrative aspects of our business.

Though we have put systems and procedures in place to minimize the likelihood of security breaches, accidents or system failures occurring; we cannot guarantee that third parties will not be able to gain unauthorized access to or otherwise breach our systems in the future. Any such unauthorized access or breach could adversely affect our business, results of operations and financial condition.

Risks Related to our Financial Condition and Capital Requirements

Our operating results may fluctuate significantly from one financial period to the next, which makes our future operating results difficult to predict. If our operating results fall below expectations, the price of the ADSs could decline.

Our financial condition and operating results have varied in the past and will continue to fluctuate from one financial period to the next due to a variety of factors, many of which are beyond our control. Factors relating to our business that may contribute to these fluctuations include changes in revenue and expenditures, external events and the business environment, and include, but are not limited to:

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Due to the various factors mentioned above, and others, the profits we generate may fluctuate significantly from one reporting period to the next, such that a period-to-period comparison of our results of operations may not be a good indication of our future performance.

In any particular period, our operating results could be different from the expectations of securities analysts or investors, which could cause the price of the ADSs to decline. While we intend to periodically report on the status of our collaborative pipeline assets, we may not always be able to provide forward-looking guidance on the timing of those next steps. In addition, we do not control the timing of disclosures of any achievements related to any of our programs that are managed by our partners. Any disclosure that may be perceived as negative, whether or not such data is related to other data that we or others release, may have a material adverse impact on the price of the ADSs.

We expect to continue to incur significant expenses for the foreseeable future in connection with our business activities.

For the six months ended June 30, 2021 and 2020, we generated gross profits of €56.3 million and €53.1 million, respectively.

Since our inception in 1993, we have devoted most of our financial resources to research and development, including preclinical development activities and the development of our platforms and we expect to continue to incur significant expenses and costs of revenue for the foreseeable future.

We anticipate that our expenses will increase substantially if:

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Any such increase in expenses could have a material adverse effect on our financial condition and results of operations.

We will require substantial additional financing to achieve our goals, and a failure to obtain this capital on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our development programs, commercialization efforts or other operations.

As of June 30, 2021, we had €449.3 million in cash, cash equivalents and investments. We estimate that the net proceeds from this offering will be approximately $                million, after deducting the estimated underwriting discounts and commissions. However, our operating plan may change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned, through public or private equity or debt financings, government or other third-party funding, sales of assets, marketing and distribution arrangements, other partnerships and licensing arrangements, or a combination of these approaches. Even if we believe we have sufficient funds for our current or future operating plans, we may seek additional capital if market conditions are favorable or if we have specific strategic considerations. Our spending will vary based on new and ongoing development and corporate activities.

To the extent that we raise additional capital through the sale of ADSs, ordinary shares or securities convertible or exchangeable into ordinary shares, your ownership interest will be diluted.

Our ability to take advantage of R&D tax credits and tax loss carryforwards may be limited.

The amount of and our ability to claim tax loss carryforwards and research and development credits may be subject to limitations and uncertainty.

R&D tax credits derived in various countries, where we run parts of our operations, form a substantial part of our other operating income and contribute positively to our financial performance. Overall, it depends on the political framework in the respective countries whether, how and to what extent we are allowed to claim R&D tax credits. Historically, the R&D tax credit policies in the countries where we operate were generally very stable and were even expanding in the recent years. However, in Italy, the legal requirements changed in 2020, leading to a significant reduction in other operating income. In case of a national or international economic crisis (e.g. due to the COVID-19 pandemic), changes in regional economic policies or other circumstances beyond our

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control, there is a higher risk that tax relief will be reduced or eliminated in the short-term and permanently due to legislative changes. A full or partial expiration of these programs or change in the eligibility criteria could negatively impact our financial performance. We monitor the political and legislative landscape on a regular basis in this regard.

In Germany, we have unused tax loss carryforwards for corporate taxes, though we have not recognized deferred tax assets related to such loss carryforwards for IFRS reporting purposes. In general, net operating loss, or NOL, carryforwards in Germany do not expire. They are, however, subject to review and possible adjustment by the German tax authorities. Furthermore, under current German tax laws, certain substantial changes in the Company’s ownership (in particular a transfer of more than 50% of the shares or voting rights to a single acquirer, including parties related to the acquirer, within a five-year period) and our business may further limit the amount of NOL carryforwards that can be used annually to offset future taxable income. In addition, we currently have net operating loss carryforwards for U.S. federal income tax purposes, some of which may expire unused.

In addition, our ability to use certain U.S. net operating losses to offset future U.S. taxable income may become further limited as a result of an “ownership change” (as a result of the offering contemplated hereby or otherwise), and these net operating losses could expire or otherwise be unavailable. As of December 31, 2020, the Company had $128 million of net operating losses for U.S. federal income tax purposes. Under the U.S. Internal Revenue Code of 1986, as amended, (the “Code”), transfers or issuances of our equity may impair or reduce the ability of the Company to utilize U.S. federal net operating loss carryforwards and certain other tax attributes in the future. Section 382 of the Code contains rules that limit the ability of a company that undergoes an “ownership change” to utilize its net operating loss and tax credit carry forwards and certain built-in losses recognized in years after the ownership change. An “ownership change” is generally defined as an increase in ownership of a corporation’s stock by more than 50 percentage points over a rolling three-year period by stockholders that own (directly, indirectly or constructively) 5% or more of the stock of a corporation at any time during the relevant rolling three-year period. If an ownership change occurs, Section 382 imposes an annual limitation on the use of pre-ownership change net operating losses, credits and certain other tax attributes to offset taxable income earned after the ownership change. The annual limitation is generally equal to the product of the applicable long-term tax exempt rate in effect for the month in which the ownership change occurs and the value of the company’s stock immediately before the ownership change (subject to some adjustments). For example, this annual limitation may be adjusted to reflect any unused annual limitation for prior years and certain recognized (or treated as recognized) built-in gains and losses for the year. In addition, Section 383 generally limits the amount of tax liability in any post-ownership change year that can be reduced by pre-ownership change tax credit carryforwards or capital loss carryforwards. Some of our net operating losses are subject to existing limitations. Following the offering contemplated hereby, our existing net operating losses may be subject to further limitations and we may not be able to fully use these net operating losses to offset future taxable income. No assurance can be given that prior transactions have not resulted in an ownership change for purposes of Section 382 of the Code or that future transactions will not result in an additional ownership change. Even if the offering contemplated hereby or a subsequent transaction does not result in an ownership change, it may materially increase the likelihood that we will undergo an ownership change in the future. Sales of our common shares by stockholders, whose interests may differ from our interests, may increase the likelihood that we or one of our subsidiaries undergoes an ownership change. If we or our subsidiaries have or were to undergo an ownership change, it could result in increased future tax liability to us. There is also a risk that, due to regulatory changes or for other unforeseen reasons, existing net operating losses could expire or otherwise be unavailable to offset future income tax liabilities.

There is a risk that we may not be able to utilize a material portion of our NOLs or credits in the countries in which we operate. In addition, the rules regarding the timing of revenue and expense recognition for tax purposes in connection with various transactions are complex and uncertain in many respects, and our recognition or utilization of any tax attributes could be subject to challenge by taxing authorities. In addition, the validity of our tax attributes could be challenged by taxing authorities. In the event any such challenge is

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sustained, our NOLs could be materially reduced or we could be determined to be a material cash taxpayer for one or more years. Furthermore, our ability to use our NOLs or credits is generally conditioned upon our attaining profitability and generating taxable income. We do not know whether or when we will generate the taxable income necessary to utilize our NOL or credit carryforwards.

Currency exchange rate fluctuations may materially affect our results of operations and financial condition.

Fluctuations in exchange rates, particularly between the U.S. dollar, the pound sterling and the euro may adversely affect our operations due to the international nature of our business. We manage this exposure via close market monitoring, forwards, natural hedges and other selective hedging instruments. Hedging transactions are entered into for future transactions that can be reliably anticipated based on our order book. Despite active currency management, exchange rate risk cannot be eliminated due to unpredictable volatility. As a result, our business and the price of our ADSs and ordinary shares may be affected by fluctuations in foreign exchange rates, which may have a significant impact on our results of operations and cash flows from period to period. Currency exchange movements also impact our reported liquidity in respect of translating liquid assets held in U.S. dollars or pound sterling into Euros.

Future acquisitions or equity investments may increase our capital requirements, dilute our shareholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks. We may not realize any benefits from these acquisitions or equity investments.

From time to time, we may evaluate various acquisitions and equity investments including licensing or acquiring complementary products, intellectual property rights, technologies or businesses. Any potential acquisition or equity investment may entail numerous risks, including but not limited to:

Some of the businesses we may seek to acquire may be marginally profitable or unprofitable. For these businesses to achieve acceptable levels of profitability, we may need to improve their management, operations,

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products and/or market penetration. We may not be successful in this regard, and we may encounter other difficulties in integrating acquired businesses into our existing operations. Further, if we undertake acquisitions, we may utilize our cash, issue dilutive securities, assume or incur debt obligations, incur large one-time expenses and acquire intangible assets that could result in significant future amortization expense.

Further, as part of our EVOequity model, from time to time we invest in start-up companies and/or development stage technology. In evaluating these opportunities, we follow an evaluation process that considers factors such as potential financial returns, new expertise in emerging drug discovery and business benefits. Despite our best efforts to calculate potential return and risk, some or all of these companies we invest in may be unprofitable at the time of, and subsequent to, our investment. We may incur losses from these investments, including the potential for future impairment charges on the investments, and the anticipated benefits of the technology and business relationships may be less than expected.

Tax laws obligate us to withhold a percentage of license payments we make to third party licensors of intellectual property rights and remit those withholdings to the applicable tax authorities, and late withholding tax payments may subject us to penalties and fees.

Under German tax laws, and the tax laws of various jurisdictions in which we operate, we are obligated to withhold a percentage of license payments we make to third parties in consideration of the grant of rights under their intellectual property, and remit those withholdings to the relevant tax authorities.

In some cases, it may be possible to seek an exemption from or the refund of certain withholding taxes from tax authorities, including the German Federal Tax Office, after filing exemptions or refund applications, and we intend to cooperate with the applicable licensor of the intellectual property in doing so if such licensor seeks to obtain any such exemption or refund where appropriate. There is a possibility, however, that the relevant claims against the licensors for a reimbursement of withholding taxes and/or the authority for a refund of withholding taxes, may in some instances, not be enforceable as a result of a licensor no longer existing, the lapse of time or any other facts preventing the enforcement of such claims.

Risks Related to our Reliance on Third Parties

If we are not able to establish partnerships on commercially reasonable terms, we may have to alter our research, development and commercialization plans.

We face significant competition in establishing relationships with appropriate partners. Whether we reach a definitive agreement for a partnership will depend upon, among other things, our assessment of the partner’s resources and expertise, the terms and conditions of the proposed partnership and the proposed partner’s evaluation of a number of factors. Those factors may include, among other things, and as applicable for the type of potential product or technology, an assessment of the opportunities and risks of our technology, the design or results of studies or trials, the likelihood of approval, if necessary, of the FDA or similar regulatory authorities outside the United States, the potential market for the subject product candidate, the costs and complexities of manufacturing and delivering such product candidate to partners, the potential of competing products and technologies and industry and market conditions generally.

Current or future partners may also consider alternative product candidates or technologies for similar indications that may be available to collaborate on and whether such a partnership could be more attractive than the one with us. Additionally, we may be restricted under existing partnership agreements from entering into future agreements on certain terms or for certain development activities with potential partners. Similarly, our partnership agreements have in the past and may in the future contain non-competition provisions that could limit our ability to enter into partnerships with future partners.

Partnerships are complex and time-consuming to negotiate and document. We may not be able to negotiate partnerships on a timely basis, on acceptable terms, or at all. If we do enter into additional partnership

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agreements, the negotiated terms may force us to relinquish rights that diminish our potential profitability from development and commercialization of the subject product candidates or others. If we are unable to enter into additional partnership agreements, we may have to curtail the research and development of the product candidate or technology for which we are seeking to collaborate, reduce or delay research and development programs, delay potential commercialization timelines, reduce the scope of any sales or marketing activities or undertake research, development or commercialization activities at our own expense. If we elect to increase our expenditures to fund research, development or commercialization activities on our own, we may need to obtain additional capital, which may not be available to us on acceptable terms or at all.

We seek to create value through partnerships. According to these partnership arrangements, our partners lead the clinical development of assets that we have ushered through the drug discovery and pre-clinical development phases. However, we may not obtain the value that we anticipate from these partnerships, as we are dependent on our partners’ ability to, for example, successfully execute clinical development, regulatory approval and commercialization. In the event of our partners’ failure, milestones, royalties and license revenues may be lower than expected or not achieved at all. In addition, our results may vary significantly due to fluctuating milestone revenues and changes in fair value of our equity investments. For example, we did not receive certain milestone payments that we had expected in 2020 as a result of delays in clinical trial starts and enrollment due to the COVID-19 pandemic. To date, none of our assets have received marketing authorization, and there can be no assurance that our partners will successfully develop and market our pipeline assets in the future.

We rely on third parties to manufacture and provide certain aspects of our products and service offerings.

We depend on certain third parties to provide us with products and services critical to our business. Such third parties include, among others, suppliers of drugs, suppliers of kits for use in our laboratories, suppliers of reagents for use in our testing equipment and providers of maintenance services for our equipment. The failure of any of these third parties to adequately provide the required products or services, or to comply with applicable regulatory requirements, could have a material adverse effect on our business.

Risks Related to Intellectual Property

Our efforts to obtain, maintain, protect, defend and/or enforce our intellectual property may be inadequate and our business could be adversely affected as a result.

Our success depends in part on our ability to develop, use and protect our proprietary methodologies, software, compositions, processes, procedures, systems, technologies and other intellectual property. To protect our intellectual property position, we primarily rely upon trade secrets, confidentiality agreements and policies, invention assignments and other contractual arrangements, trademark registrations and copyrights. Although our patent portfolio is not material to certain of our business as a whole, we have filed patent applications in the United States, Europe and abroad related to our pipeline assets, processes or other technologies (including methods of manufacture). Our collaboration partners also file patent applications on their development assets on which we may earn milestones and royalties. We may not be able to apply for patents on certain aspects of our current or future pipeline assets, processes or other technologies and their uses in a timely fashion or at a reasonable cost.

Even issued patents may later be found invalid or unenforceable or may be modified or revoked in proceedings before various patent offices or in courts in the United States, Europe or other jurisdictions. The degree of future protection for our intellectual property and other proprietary rights is uncertain. Only limited protection may be available and may not adequately protect our rights or permit us to gain or keep any competitive advantage. Additionally, our intellectual property may not provide us with sufficient rights to exclude others from copying our processes and technologies or commercializing pipeline assets. If we do not adequately obtain, maintain, protect, defend and/or enforce our intellectual property and proprietary technology, competitors may be able to use our proprietary technologies and erode or negate any competitive advantage we may have, which could have a material adverse effect on our financial condition and results of operations.

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The patent application process is subject to numerous risks and uncertainties, and there can be no assurance that we or any of our current or future licensors or partners will be successful in prosecuting, obtaining, protecting, maintaining, enforcing and/or defending patents and patent applications necessary or useful to protect our proprietary technologies (including pipeline assets and methods of manufacture) and their uses. These risks and uncertainties include, from time to time, the following:

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The patent position of pharmaceutical and biotechnology companies generally is highly uncertain, involves complex legal and factual questions, and has been the subject of much litigation in recent years. The standards that the USPTO, DPMA, EPO and their counterparts use to grant patents are not always applied predictably or uniformly and can change. Similarly, the ultimate degree of protection that will be afforded to inventions, including ours, in the United States and other countries, remains uncertain and is dependent upon the scope of the protection decided upon by patent offices, courts and lawmakers. Moreover, there are periodic changes in patent law, as well as discussions in the Congress of the United States and in international jurisdictions about modifying various aspects of patent law and such changes in patent laws or in interpretations of patent laws may diminish the value of our intellectual property. There is no uniform, worldwide policy regarding the subject matter and scope of claims granted or allowable in pharmaceutical or biotechnology patents. As a result, the issuance, scope, validity, enforceability, and commercial value of our patent rights are highly uncertain. In certain countries, for example, methods for the medical treatment of humans are not patentable. More generally, the laws of some countries do not protect intellectual property rights to the same extent as U.S. laws, and those countries may lack adequate rules and procedures for granting, maintaining, protecting, defending and/or enforcing our intellectual property rights.

Furthermore, the patent prosecution process is also expensive and time-consuming, and we may not be able to file, prosecute, maintain, protect, defend, enforce or license all necessary or desirable patents or patent applications, as applicable, at a reasonable cost or in a timely manner or in all potentially relevant jurisdictions. It is possible that defects of form in the preparation or filing of our patents or patent applications may exist, or may arise in the future, for example with respect to proper priority claims, inventorship, claim scope, or requests for patent term adjustments. It is also possible that we will fail to identify patentable aspects of our research and development output in time to obtain patent protection. If we delay filing a patent application, and a competitor files a patent application on the same or similar invention before we do, our ability to secure patent rights may be limited and we may not be able to patent the invention at all. Even if we can patent the invention, we may be able to patent only a limited scope of the invention, and the limited scope may be inadequate to protect our assets and technologies, or to block competitor’s products and technologies that are similar or adjacent to ours. Our earliest patent filings have been published. A competitor may review our published patent filings and arrive at the same or similar technology advances for our assets as we developed. If the competitor files a patent application on such an advance before we do, then we may no longer be able to protect that aspect of our assets and technologies and we may require a license from the competitor, which may not be available on commercially viable terms or at all. Moreover, we may not develop additional proprietary products, methods and technologies that are patentable. We may not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the rights to patents licensed from or to third parties. Therefore, these patents and applications may not be prosecuted and enforced by such third parties in a manner consistent with the best interests of our business. We also rely to a certain extent on trade secrets, know-how, and technology, which are not protected by patents, to maintain our competitive position. If any trade secret, know-how or other technology not protected by a patent were to be disclosed to or independently developed by a competitor, our business and financial condition could be materially adversely affected.

Our ability to enforce our owned (solely or jointly) and in-licensed patent and other intellectual property rights depends on our ability to detect infringement, misappropriation and other violation of such patents and other intellectual property. It may be difficult to detect infringers, misappropriators and other violators who do not advertise the components or methods that are used in connection with their products and services. Moreover, it may be difficult or impossible to obtain evidence of infringement, misappropriation or other violation in a competitor’s or potential competitor’s product or service, and in some cases we may not be able to introduce obtained evidence into a proceeding or otherwise utilize it to successfully demonstrate infringement. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded if we were to prevail may not be commercially meaningful.

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In addition, proceedings to enforce or defend our owned (solely or jointly) or in-licensed patents could put our patents at risk of being invalidated, held unenforceable or interpreted narrowly. Such proceedings could also provoke third parties to assert claims against us, including that some or all of the claims in one or more of our patents are invalid or otherwise unenforceable. Such challenges may result in loss of patent rights, loss of exclusivity, or in patent claims being narrowed, invalidated or held unenforceable, which could limit our ability to stop others from using or commercializing similar or identical product candidates, processes or other technologies or limit the duration of the patent protection of our pipeline assets, processes or other technologies. If any of our owned (solely or jointly) or in-licensed patents covering our pipeline assets, processes or other technologies are narrowed, invalidated or found unenforceable, or if a court found that valid, enforceable patents held by third parties covered one or more of our pipeline assets, processes or other technologies, our competitive position could be harmed or we could be required to incur significant expenses to protect, enforce or defend our rights. If we initiate lawsuits to protect, defend or enforce our patents, or litigate against third-party claims, such proceedings would be expensive and would divert the attention of our management and technical personnel, even if the eventual outcome is favorable to us.

The degree of future protection for our intellectual property and other proprietary rights is uncertain, and we cannot ensure that:

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Further, while software and other of our proprietary works may be protected under copyright law, we have chosen not to register any copyrights in these works, and instead, we primarily rely on protecting our software as unregistered copyright (in jurisdictions where such protection is available) or trade secret. In order to bring a copyright infringement lawsuit in the United States, the copyright must be registered. Accordingly, the remedies and damages available to us for unauthorized use of our software may be limited.

We or our partners may not be successful in obtaining, maintaining, protecting or defending the necessary intellectual property rights to allow us to identify and develop pipeline assets, processes or other technologies.

We currently have rights to certain intellectual property, through our owned (solely or jointly) and in-licensed patents and other intellectual property rights, relating to identification and development of our pipeline assets, processes or other technologies. Our pipeline assets, processes or other technologies could require the use of intellectual property and other proprietary rights held by third parties and their success could depend in part on our ability to acquire, in-license or use such intellectual property and proprietary rights. In addition, our pipeline assets may require specific formulations to work effectively and efficiently and these intellectual property and other proprietary rights may be held by others. We may be unable to secure such licenses or otherwise acquire or in-license any compositions, methods of use, processes or other third-party intellectual property rights from third parties that we identify as necessary or consider attractive, on reasonable terms, or at all, for pipeline assets, processes and other technologies that we may develop. The licensing and acquisition of third-party intellectual property rights is a competitive area, and a number of more established companies are also pursuing strategies to license or acquire third-party intellectual property rights that we, or our partners, may consider attractive or necessary. These established companies may have a competitive advantage over us due to their size, cash resources, and greater clinical development and commercialization capabilities.

In some circumstances where we grant licenses to or collaborate with our partners who retain ownership of their intellectual property, we may not have the right to control the preparation, filing, prosecution, maintenance, enforcement and defense of patents and patent applications covering the technology. Therefore, we cannot be certain that these patents and patent applications will be prepared, filed, prosecuted, maintained, protected, enforced or defended in a manner consistent with the best interests of our business. Any patents or patent applications that we in-license may be challenged, narrowed, circumvented, invalidated or held unenforceable, or our licensors or partners may not properly maintain such patents or patent applications and they may expire. If we, our licensees or partners fail to obtain, maintain, defend, protect or enforce the intellectual property we license to them, or our partners license to us, we could lose our rights to the intellectual property and our competitors could market competing products using the inventions in such intellectual property. In the event we breach any of our obligations related to our licenses, we may incur significant liability to our partners. Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations and prospects.

We sometimes collaborate with academic institutions in certain aspects of our preclinical research or development. Typically, these institutions provide us with an option to negotiate a license to certain of the institution’s rights in technology resulting from such collaboration. However, these institutions may not honor our option for intellectual property rights or we may otherwise be unable to negotiate a license within the specified time frame or under terms that are acceptable to us. If we are unable to do so, the institution may offer the intellectual property rights to other parties, potentially blocking our ability to pursue our program or otherwise continue to develop certain pipeline assets, processes or other technologies.

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If our trademarks and trade names are not adequately protected, we may not be able to build or maintain name recognition in our markets of interest and our business, financial condition, results of operations, cash flows and prospects may be adversely affected.

Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic, lapsed or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names or may be forced to stop using these names or marks which we need for name recognition by potential partners or customers in our markets of interest. Third parties have filed, and may in the future file, for registration of trademarks similar or identical to our trademarks, thereby impeding our or developing common law rights in such trademark or any other trademarks that are similar or identical to our trademarks, and if we are not successful in challenging such rights and defending against challenges to our trademarks, we may not be able to use such trademarks to develop brand recognition of our technologies, products or services. Additionally, any trademarks we try to register may be rejected. Even if we successfully register trademarks, opposition or cancellation proceedings may be filed against our trademarks, and our trademarks may not survive such proceedings. Further, there could be potential trade name or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names. Also, we have and may in the future enter into agreements with owners of such third party trade names or trademarks to avoid potential trademark litigation which may limit our ability to use our trade names or trademarks in certain fields of business. We may also in the future license our trademarks and trade names to third parties, such as distributors. Though these license agreements may provide guidelines for how our trademarks and trade names may be used, a breach of these agreements or misuse of our trademarks and tradenames by our licensees may jeopardize our rights in or diminish the goodwill associated with our trademarks and trade names.

Over the long term, if we are unable to establish or maintain name recognition based on our trademarks and trade names, we may not be able to compete effectively in our markets of interest and our business, financial condition, results of operations, cash flows and prospects may be adversely affected. In addition, our efforts to enforce or protect our proprietary rights related to trademarks and trade names may be ineffective and could result in substantial costs and diversion of resources and could adversely affect our business, financial condition, results of operations and prospects.

Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance fees, renewal fees, annuity fees, and various other fees on patents and applications will be due to be paid to various patent agencies in several stages over the lifetime of the patents or applications. We employ and rely on third parties, including outside counsel to pay these fees for us; however, we cannot guarantee that payment of these fees will be on time. The USPTO and various non-U.S. governmental patent agencies (such as the DPMA and EPO) require compliance with a number of procedural, documentary, fee payment, and other similar provisions during the patent application process. We employ reputable law firms and other professionals to help keep us in compliance, and in many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules. However, there are situations in which non-compliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Non-compliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. We are also dependent on our licensors to take the necessary action to comply with these requirements with respect to our in-licensed intellectual property, and we cannot guarantee that they will do so. In such an event, our competitors might be able to enter the market with similar or identical product candidates, processes or other technologies, and this would have a material adverse impact on our business, financial condition, results of operations and prospects.

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We depend in part on out-licensing and partnership arrangements for late-stage development, marketing and commercialization of our pipeline assets.

We depend in part on out-licensing arrangements for late-stage development, marketing and commercialization of our pipeline assets. Dependence on out-licensing arrangements subjects us to a number of risks, including the risk that:

If we or any of our licensees breach or terminate their agreements with us, or if any of our licensees otherwise fail to conduct their development and commercialization activities in a timely manner or there is a dispute about their obligations, we may need to seek other licensees, or we may have to develop our own internal sales and marketing capability for our pipeline assets. Our dependence on our licensees’ experience and the rights of our licensees will limit our flexibility in considering alternative out- licensing arrangements for our pipeline assets. Any failure to successfully develop these arrangements or failure by our licensees to successfully develop or commercialize any of our pipeline assets in a competitive and timely manner, will have a material adverse effect on the commercialization of our pipeline assets.

Any of our issued patents covering our assets could be narrowed, found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad, including the USPTO, DPMA and EPO

Our owned (solely or jointly) and licensed patents and patent applications may be subject to validity, enforceability and priority disputes. The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability. Some of our patents or patent applications (including licensed patents and patent applications) may be challenged at a future point in time in opposition, derivation, reexamination, inter partes review, post-grant review or interference or other similar proceedings. Any successful third-party challenge to our or our licensors’ patents in this or any other proceeding could result in the unenforceability or invalidity of such patents, which may lead to increased competition to our business, which could have a material adverse effect on our business, financial condition, results of operations and prospects. In addition, if we or our licensors initiate legal proceedings against a third party to enforce a patent covering our assets, the defendant could counterclaim that such patent covering our assets, as applicable, is invalid and/or unenforceable. In patent litigation in the United States and various non-U.S. jurisdictions, defendant counterclaims alleging invalidity or unenforceability are commonplace. There are numerous grounds upon which a third party can assert invalidity or unenforceability of a patent. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness or non-enablement. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld

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relevant information from the relevant patent office, or made a misleading statement, during prosecution. A litigant or the USPTO itself could challenge our patents on this basis even if we believe that we have conducted our patent prosecution in accordance with the duty of candor and in good faith. The outcome following such a challenge is unpredictable. Third parties may also raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation. Such mechanisms include ex parte re-examination, inter partes review, post-grant review and derivation proceedings in the United States, and equivalent proceedings in non-U.S. jurisdictions, such as opposition proceedings. Such proceedings could result in revocation of or amendment to our or our licensors’ patents in such a way that they no longer cover and protect our assets. With respect to the validity of our or our licensors’ patents, for example, we cannot be certain that there is no invalidating prior art of which we, our licensors, our or their respective patent counsel and the patent examiner were unaware during prosecution. The outcome following legal assertions of invalidity and unenforceability during patent litigation is unpredictable. If a defendant or other third party were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent protection on certain aspects of our assets and technologies, which could have a material adverse effect on our business, financial condition, results of operations and prospects. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, regardless of the outcome, it could dissuade companies from collaborating with us to license intellectual property, or develop or commercialize current or future products.

We may not be aware of all third-party intellectual property rights potentially relating to our assets. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until approximately 18 months after filing or, in some cases, not until such patent applications issue as patents. We might not have been the first to make the inventions covered by each of our pending patent applications and we might not have been the first to file patent applications for these inventions. To determine the priority of these inventions, we may have to participate in interference proceedings, derivation proceedings or other post-grant proceedings declared by the USPTO, or other similar proceedings in non-U.S. jurisdictions (e.g. within the jurisdiction of the DPMA or EPO), that could result in substantial cost to us and the loss of valuable patent protection. The outcome of such proceedings is uncertain. No assurance can be given that other patent applications will not have priority over our patent applications. In addition, changes to the patent laws of the United States allow for various post-grant opposition proceedings that have not been extensively tested, and their outcome is therefore uncertain. Furthermore, if third parties bring these proceedings against our patents, regardless of the merit of such proceedings and regardless of whether we are successful, we could experience significant costs and our management may be distracted. Any of the foregoing events could have a material adverse effect on our business, financial condition, results of operations and prospects.

Third parties, ranging from our competitors to non-practicing entities or patent assertion entities, may assert that we are employing their intellectual property and other proprietary technology without authorization, or we may become involved in lawsuits to protect or enforce our intellectual property, any of which could be expensive, time-consuming and unsuccessful.

Our commercial success depends in part on our ability and the ability of future partners to develop, manufacture, market and sell our assets and use our assets and technologies without infringing, misappropriating or otherwise violating the intellectual property rights of third parties. There is a substantial amount of litigation involving patents and other intellectual property rights in the biotechnology industry, as well as administrative proceedings for challenging patents, including interference, derivation, inter partes review, post-grant review, and re-examination proceedings before the USPTO, or oppositions and other comparable proceedings in foreign jurisdictions. We may be exposed to, or threatened with, future litigation by third parties having patent or other intellectual property rights alleging that our assets, manufacturing methods, software and/or technologies infringe, misappropriate or otherwise violate their intellectual property rights.

Numerous issued patents and pending patent applications that are owned by third parties exist in the fields in which we are developing our assets and technologies. It is not always clear to industry participants,

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including us, the claim scope that may issue from pending patent applications owned by third parties or which patents cover various types of products, technologies or their methods of use or manufacture. Thus, because of the large number of patents issued and patent applications filed in our fields, it is difficult to conclusively assess our freedom to operate without infringing on third party rights and there may be a risk that third parties, including our competitors, may allege they have patent rights encompassing our assets, technologies or methods and that we are employing their proprietary technology without authorization. We cannot guarantee that any of our patent searches or analyses, including the identification of relevant patents, the scope of patent claims or the expiration of relevant patents, are complete or thorough, nor can we be certain that we have identified each and every third-party patent and pending application in the United States and abroad that is relevant to or necessary for the commercialization of our assets, processes, platforms and other technologies in any jurisdiction. The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution history. Our interpretation of the relevance or the scope of a patent or a pending application may be incorrect. For example, we may incorrectly determine that our assets are not covered by a third-party patent or may incorrectly predict whether a third-party’s pending application will issue with claims of relevant scope. Our determination of the expiration date of any patent in the United States or abroad that we consider relevant may be incorrect. Our failure to identify and correctly interpret relevant patents may negatively impact our ability to develop and market our assets, processes, platforms and other technologies.

There may be third-party patents or patent applications with claims to materials, formulations, methods of manufacture or methods for treatment related to our processes, technology, and the use, development, manufacture or commercialization of our pipeline assets. As patent applications can take many years to issue, there may be currently pending patent applications, which may later result in issued patents that our processes, technology or pipeline assets may infringe. In addition, third parties may obtain patents in the future and claim that our processes, technology or pipeline assets infringe upon these patents. If third parties, including our competitors, believe that our pipeline assets or technologies infringe, misappropriate or otherwise violate their intellectual property, such third parties may seek to enforce their intellectual property, including patents, by filing an intellectual property-related lawsuit, including patent infringement lawsuit, against us. Even if we believe third-party intellectual property claims are without merit, there is no assurance that a court would find in our favor on questions of infringement, validity, enforceability, or priority.

If any of these third parties were to assert these patents against us and we are unable to successfully defend against any such assertion, we may be required, including by court order, to cease the development and commercialization of the infringing products or technology and we may be required to redesign such products and technologies so they do not infringe such patents, which may not be possible or may require substantial monetary expenditures and time. For instance, if any third-party patents were held by a court of competent jurisdiction to cover the manufacturing process of any of our pipeline assets, any molecules formed during the manufacturing process or any final product itself, the holders of any such patents may obtain injunctive or other equitable relief, which could effectively block our ability to develop and commercialize such pipeline asset unless we obtained a license under the applicable patents, or until such patents expire. Similarly, if any third-party patents were held by a court of competent jurisdiction to cover aspects of our formulations, processes for manufacture or methods of use, including combination therapy, the holders of any such patents may be able to block our ability to develop and commercialize the applicable pipeline asset unless we obtained a license or until such patent expires. In either case, such a license may not be available on commercially reasonable terms, or at all, or may be non-exclusive.

Also, we may choose to challenge, including in connection with any allegation of patent infringement by a third party, the patentability, validity or enforceability of any third-party patent that we believe may have applicability in our field, and any other third-party patent that may be asserted against us. Such challenges may be brought either in court or by requesting that the USPTO, DPMA, EPO, or other foreign patent offices review the patent claims, such as in an ex parte re-examination, inter partes review, post-grant review proceeding or opposition proceeding. However, there can be no assurance that any such challenge by us or any third party will be successful. Even if such proceedings are successful, these proceedings are expensive and may consume our

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time or other resources, distract our management and technical personnel. There can be no assurance that our defenses of non-infringement, invalidity or unenforceability will succeed.

Third parties, including our competitors, could be infringing, misappropriating or otherwise violating our owned (solely or jointly) and in-licensed intellectual property rights. Monitoring unauthorized use of our intellectual property is difficult and costly. We may not be able to detect unauthorized use of, or take appropriate steps to enforce, our intellectual property rights. From time to time, we seek to analyze our competitors’ products and services, and may in the future seek to enforce our rights against potential infringement, misappropriation or violation of our intellectual property. However, the steps we have taken to protect our intellectual property rights may not be adequate to enforce our rights as against such infringement, misappropriation or violation of our intellectual property. Any inability to meaningfully enforce our intellectual property rights could harm our ability to compete and reduce demand for our assets and technologies. Litigation proceedings may be necessary for us to enforce our patent and other intellectual property rights. In any such proceedings, a court may refuse to stop the other party from using the technology at issue on the grounds that our owned (solely or jointly) and in-licensed patents do not cover the technology in question. Further, in such proceedings, the defendant could counterclaim that our intellectual property is invalid or unenforceable and the court may agree, in which case we could lose valuable intellectual property rights, which could allow third parties to commercialize technology or products similar to ours and compete directly with us, without payment to us, or could require us to obtain license rights from the prevailing party in order to be able to manufacture or commercialize our assets without infringing such party’s intellectual property rights, and if we are unable to obtain such a license, we may be required to cease commercialization of our assets and technologies, any of which could have a material adverse effect on our business, financial condition, results of operations and prospects. The outcome in any such proceedings are unpredictable.

Even if resolved in our favor, litigation or other legal proceedings relating to our intellectual property rights, regardless of whether we are defending against or asserting any intellectual property-related proceeding, may cause us to incur significant expenses, and could distract our technical and management personnel from their normal responsibilities. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources. Any of the foregoing, or any uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could compromise our ability to compete in the marketplace, including our ability to raise the funds necessary to continue our operations. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar adverse effect on our business, financial condition, results of operations and prospects.

We may be subject to claims challenging the inventorship of our patents and other intellectual property.

We may be subject to claims that former employees, partners or other third parties have an interest in our patents or other intellectual property as an inventor or co-inventor. The failure to name the proper inventors on a patent application can result in the patents issuing thereon being unenforceable. Inventorship disputes may arise from conflicting views regarding the contributions of different individuals named as inventors, the effects of foreign laws where foreign nationals are involved in the development of the subject matter of the patent, conflicting obligations of third parties involved in developing our pipeline assets or as a result of questions regarding co-ownership of potential joint inventions. Litigation may be necessary to resolve these and other claims challenging inventorship and/or ownership. Alternatively, or additionally, we may enter into agreements to clarify the scope of our rights in such intellectual property. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverse effect on our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

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Our licensors may have relied on third-party consultants or partners or on funds from third parties, such as the U.S. government, such that our licensors are not the sole and exclusive owners of the patents we in-licensed. If other third parties have ownership rights or other rights to our in-licensed patents, they may be able to license such patents to our competitors, and our competitors could market competing products and technology. This could have a material adverse effect on our competitive position, business, financial conditions, results of operations, and prospects.

In addition, we generally require our employees and contractors who may be involved in the conception or development of intellectual property to execute agreements to assign or assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property that we regard as our own. The assignment of intellectual property rights may not be self-executing, or the assignment agreements may be breached, and we may be forced to bring claims against third parties, or defend claims that they may bring against us, to determine the ownership of what we regard as our intellectual property. Such claims could have a material adverse effect on our business, financial condition, results of operations, and prospects.

Further, the laws of some other countries do not protect intellectual property and other proprietary rights or establish ownership of inventions to the same extent or in the same manner as the laws of the United States. Our employees work in Germany, the United Kingdom, France, Italy, Austria and the United States and are subject to the employment laws of each respective country. For example, ideas, developments, discoveries and inventions made by employees in Germany are subject to the provisions of the German Act on Employees’ Inventions (Gesetz über Arbeitnehmererfindungen), which regulates the ownership of, and compensation for, inventions made by employees. We face the risk that disputes can occur between us and our employees or former employees pertaining to alleged non-adherence to the provisions of this act that may be costly to defend and take up our management’s time and efforts whether we prevail or fail in any such dispute. There is a risk that the compensation we provided to employees who assign patents to us may be deemed to be insufficient and we may be required under German law, or any corresponding laws in other countries, to increase the compensation due to such employees for the use of the patents. In those cases where employees’ rights have not been assigned to us, we may need to pay compensation for the use of those patents. If we are required to pay additional compensation or face other disputes under the German Act on Employees’ Inventions (Gesetz über Arbeitnehmererfindungen) or any corresponding laws in other jurisdictions, our business, results of operations and financial condition could be adversely affected.

In the event of a successful claim of infringement, misappropriation or other violation against us, we may have to pay substantial damages.

In the event of a successful claim of infringement, misappropriation or other violation against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, pay royalties, redesign our infringing products, or obtain one or more licenses from third parties, which may not be made available on commercially favorable terms, if at all, or may require substantial time and expense. Even if such license were available, it may require substantial payments or cross-licenses under our intellectual property rights, and it may only be available on a non-exclusive basis, in which case third parties, including our competitors, could use the same licensed intellectual property to compete with us.

In addition, in connection with certain license, partnership, and other agreements, we have agreed to indemnify certain third parties for certain costs incurred in connection with litigation relating to intellectual property rights or the subject matter of the agreements. The claims may require us to initiate or defend protracted and costly litigation on behalf of licensees and other parties regardless of the merits of these claims. If any of these claims succeed, we may be forced to pay damages on behalf of those parties or may be required to obtain licenses for the products they use. The cost to us of any litigation or other proceeding relating to intellectual property rights or the subject matter of the agreements, even if resolved in our favor, could be substantial.

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Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments in any litigation or other intellectual property proceedings. If securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of the ADSs.

Changes in patent law in the United States or in other countries could diminish the value of patents in general, thereby impairing our ability to protect our pipeline assets, processes or other technologies.

As is the case with other biotechnology companies, our success is heavily dependent on our intellectual property rights, particularly patents that we own (solely or jointly) and in-license. Obtaining and enforcing patents in the biotechnology industry involve both technological and legal complexity, and therefore obtaining and enforcing biotechnology patents is costly, time-consuming and inherently uncertain. Moreover, there are periodic changes in patent law. For example, after March 2013, under the Leahy-Smith America Invents Act, or the America Invents Act, the United States transitioned to a first inventor to file system in which, assuming that other requirements for patentability are met, the first inventor to file a patent application became entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention. Since patent applications in the United States and most other countries are confidential for a period of time after filing or until issuance, we cannot be certain that we or our licensors were the first to either file any patent application related to our assets and other proprietary technologies we may develop or invent any of the inventions claimed in our or our licensor’s patents or patent applications. Even where we have a valid and enforceable patent, we may not be able to exclude others from practicing the claimed invention where the other party can show that they used the invention in commerce before our filing date or the other party benefits from a compulsory license.

The America Invents Act also included a number of significant changes that affected both patent prosecution and litigation. These changes include allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to challenge the validity of a patent by USPTO administered post-grant proceedings, including post-grant review, inter partes review and derivation proceedings. Further, because of a lower evidentiary standard in these USPTO post-grant proceedings compared to the evidentiary standard in United States federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action. Accordingly, a third party may attempt to use the USPTO procedures to invalidate our patent claims that would not have been invalidated if first challenged by the third party as a defendant in a district court action. The America Invents Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business, financial condition, results of operations and prospects.

In addition, recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by the U.S. Congress, the federal courts and the USPTO, and their equivalents in other jurisdictions, the laws and regulations governing patents could change in unpredictable ways that could have a material adverse effect on our existing patent portfolio and our ability to obtain, maintain, protect, defend or enforce our intellectual property in the future.

If we are unable to protect the confidentiality of our trade secrets, our business and competitive position could be harmed.

In addition to seeking patent protection for our pipeline assets, processes or other technologies we also rely on trade secret protection and confidentiality agreements to maintain our competitive position and protect

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proprietary know-how that is not patentable, processes for which patents are difficult to enforce and any other elements of our asset discovery and development processes that involve proprietary know-how, information or technology that is not covered by patents. Certain elements of our assets and technologies, including components of our software and processes for manufacturing, may involve proprietary know-how, information or technology that is not covered by patents, and as such, we may consider trade secrets and know-how to be our primary intellectual property with respect to such aspects of our assets and technologies. However, trade secrets and know-how may be difficult to protect. In particular, we anticipate that with respect to our technologies, these trade secrets and know-how may over time be disseminated within the industry through independent development, the publication of journal articles describing the methodology, and the movement of personnel from academic to industry scientific positions.

We seek to protect these trade secrets, know-how and other proprietary technology, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees, corporate partners, academic institutions, outside scientific partners, CROs, contract manufacturers, consultants, advisors, potential acquisition candidates and other third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants and require all of our employees and key consultants who have access to our trade secrets, proprietary know-how, information or technology to enter into confidentiality agreements. We cannot guarantee that we have entered into such agreements with each party that may have or have had access to our trade secrets or proprietary technology and processes. Despite our best efforts, any of these parties may breach the agreements and we cannot be certain that our trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access (such as through cybersecurity breach) to our trade secrets or independently develop substantially equivalent information and techniques. For example, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Such agreements may not be enforceable or may not provide meaningful protection for our trade secrets or other proprietary information in the event of unauthorized use or disclosure or other breaches of the agreements, and we may not be able to prevent such unauthorized disclosure, which could adversely impact our ability to establish or maintain a competitive advantage in the market.

Monitoring unauthorized disclosure is difficult, and we do not know whether the steps we have taken to prevent such disclosure are, or will be, adequate. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret or know-how is difficult, expensive and time-consuming, distractive to our personnel and the outcome is unpredictable. In addition, some courts both inside and outside the United States are less willing or unwilling to protect trade secrets and know-how. We may need to share our proprietary information, including trade secrets, with future business partners, partners, contractors and others located in countries at heightened risk of theft of trade secrets, including through direct intrusion by private parties or foreign actors, and those affiliated with or controlled by state actors. We also seek to preserve the integrity and confidentiality of our confidential proprietary information by maintaining physical security of our premises and physical and electronic security of our information technology systems, but it is possible that these security measures could be breached and we may not have adequate remedies for such breach.

If any of our trade secrets or know-how were to be lawfully obtained or independently developed by a competitor or other third party, we would have no right to prevent them from using that technology or information to compete with us. If we are unable to prevent unauthorized material disclosure of our intellectual property to third parties, we will not be able to establish or maintain a competitive advantage in our market, which could materially adversely affect our business, operating results, financial condition and prospects.

We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information or alleged trade secrets of third parties or competitors or are in breach of non-competition or non-solicitation agreements with our competitors or their former employers.

We have employed and expect to employ individuals who were previously employed at universities or other companies, including our competitors or potential competitors. Although we try to ensure that our

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employees, consultants, advisors and independent contractors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that our employees, advisors, consultants or independent contractors have inadvertently or otherwise used or disclosed intellectual property, including trade secrets or other proprietary information of their former employers or other third parties, or to claims that we have improperly used or obtained such trade secrets. Litigation may be necessary to defend against these claims. If we fail in defending such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel and face increased competition to our business. Any such litigation or the threat thereof may adversely affect our ability to hire employees or contract with advisors, contractors and consultants. A loss of key research personnel work product could hamper or prevent our ability to commercialize potential products, which could harm our business. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management. This type of litigation or proceeding could substantially increase our operating losses and reduce our resources available for development activities. Some of our competitors may be able to sustain the costs of this type of litigation or proceedings more effectively than we can because of their substantially greater financial resources.

We will not seek to protect our intellectual property rights in all jurisdictions throughout the world, and we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek protection.

Filing, prosecuting and defending patents on pipeline assets, processes or other technologies in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can be less extensive than those in the United States. In addition, the laws of some countries do not protect intellectual property rights to the same extent as laws in the United States or Europe. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States or Europe, or from selling or importing products made using our inventions in and to the United States or other jurisdictions. Competitors and other third parties may use our technologies in jurisdictions where we have not obtained patent protection to develop their own pipeline assets and further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that in the United States or Europe. These products may compete with our pipeline assets in jurisdictions where we do not have any issued patents, and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property protection, particularly those relating to biotechnology products, which could make it difficult for us to stop the infringement, misappropriation or other violation of our patents and other intellectual property or development, marketing and commercialization of competing product candidates, processes or other technologies in violation of our intellectual property and other proprietary rights generally. The legal systems in certain countries may also favor state-sponsored or companies headquartered in particular jurisdictions over our first-in-time patents and other intellectual property protection. The absence of harmonized intellectual property protection laws and effective enforcement makes it difficult to ensure consistent respect for patent, trade secret, and other intellectual property rights on a worldwide basis. As a result, it is possible that we will not be able to enforce our rights against third parties that misappropriate our proprietary technology in those countries.

The lifespans of our patents may not be sufficient to effectively protect our or our partners’ assets, technologies and business.

Patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after its first effective non-provisional filing date, assuming maintenance fees are timely paid after the patent has issued. Most international jurisdictions also provide a 20-year nominal patent term, though many require payment of regular, often annual, annuities to maintain pendency of an application or viability of an

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issued patent. In some jurisdictions, one or more options for extension of a patent term may be available, but even with such extensions, the lifespan of a patent, and the protection it affords, is limited. Even if patents covering our or our partners’ assets, processes and other technologies and their uses are obtained, once the patent term has expired, we may be subject to competition from third parties that can then use the inventions included in such patents to create competing products and technologies. In addition, although upon issuance in the United States a patent’s lifespan can be increased based on certain delays caused by the USPTO, this increase can be reduced or eliminated based on certain delays caused by the patent applicant during patent prosecution. Given the amount of time required for the development, testing and regulatory review of new pipeline assets, patents protecting such pipeline assets might expire before or shortly after such pipeline assets are commercialized. If any patents that we own (solely or jointly) or in-license expire, we would not be able to stop others from using or commercializing similar or identical technology and products, and our competitors could market competing products, processes and other technologies. Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations and prospects.

If we or our partners do not obtain patent term extension and data exclusivity for any assets we or our partners may develop, our business may be materially harmed.

Depending upon the timing, duration and specifics of any FDA marketing approval of any pipeline assets we may develop, one or more of our U.S. patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Action of 1984 (the “Hatch-Waxman Amendments”). The Hatch-Waxman Amendments permit a patent extension term of up to five years as compensation for patent term lost during the FDA regulatory review process. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, only one patent may be extended and only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended. However, we or our partners may not be granted an extension because of, for example, failing to exercise due diligence during the testing phase or regulatory review process, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents, or otherwise failing to satisfy applicable requirements. Moreover, the applicable time period or the scope of patent protection afforded could be less than we request. If we are unable to obtain patent term extension or the term of any such extension is less than we request, our competitors may obtain approval of competing products following our patent expiration, and our business, financial condition, results of operations and prospects could be materially harmed.

We utilize third-party open source software components, and failure to comply with the terms of the underlying open source software licenses could restrict our ability to commercialize our technology and require us to provide third parties access to our proprietary software.

We utilize software licensed by third parties under open source software licenses. Use and distribution of open source software may entail greater risks than use of third-party commercial software, as open source software licensors generally do not provide support, warranties, indemnification or other contractual protections regarding infringement claims or the quality of the code. Some open source software licenses contain requirements that the licensee make its source code publicly available if the licensee creates modifications or derivative works using the open source software, depending on the type of open source software the licensee uses and how the licensee uses it. If we combine our proprietary technology with open source software in a certain manner, we could, under certain open source software licenses, be required to release the source code of our proprietary technology to the public for free. This would allow our competitors and other third parties to create similar copies of our platform with less development effort and time and ultimately could result in a loss of our services and revenue, which could have a material adverse effect on our business, financial condition, results of operations and prospects. Alternatively, to avoid the public release of the affected portions of our source code, we could be required to expend substantial time and resources to re-engineer some or all of our software. In addition, some companies that use third-party open source software have faced claims challenging their use of such open source software and their compliance with the terms of the applicable open source license. We may face claims from third parties claiming ownership of what we believe to be open source software, or claiming

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non-compliance with the applicable open source licensing terms, including claims that demand release of source code for the open source software, derivative works or our proprietary source code that was developed using, or that is distributed with, such open source software. These claims could also result in litigation and could require us to make our proprietary technology source code freely available, devote additional research and development resources to re-engineer our technology, seek costly licenses from third parties or otherwise incur additional costs and expenses, any of which could result in reputational harm and would have a negative effect on our business and operating results. Use of open source software may also present additional security risks because the public availability of such software may make it easier for hackers and other third parties to compromise or attempt to compromise our platform.

Although we review our use of open source software to avoid subjecting our proprietary technology to conditions we do not intend, the terms of many open source software licenses have not been interpreted by courts in the United States, and there is a risk that these licenses could be construed in a way that could impose unanticipated conditions or restrictions on our ability to commercialize our proprietary technology. Moreover, we cannot assure investors that our processes for monitoring and controlling our use of open source software in our technology will be effective. If we are held to have breached the terms of an open source software license, we could be subject to damages, required to seek licenses from third parties to continue offering or using our technology on terms that are not economically feasible, to re-engineer our technology, to discontinue the access to our platform if re-engineering could not be accomplished on a timely basis, or to make generally available, in source code form, our proprietary source code, any of which could adversely affect our business, financial condition, results of operations and prospects.

Intellectual property rights do not necessarily address all potential threats to our competitive advantage.

The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage. For example:

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Should any of these events occur, they could have a material adverse effect on our business, financial condition, results of operations and prospects.

Risks Related to Regulation and Legal Compliance Matters

Our activities, and the activities of our customers, are and will continue to be subject to extensive government regulation to ensure patient health.

We are subject to various local, state, federal, international and transnational laws and regulations, and, in the future, any changes to such laws and regulations could adversely affect us.

We and our pharmaceutical and biotechnology customers and partners are subject to extensive regulations by the FDA and similar regulatory authorities in other countries for development, manufacturing and commercializing products for therapeutic or diagnostic use. Such regulations include but are not limited to, restrictions on testing on animals and humans, manufacturing, safety, efficacy, labeling, sale, advertising promotion and distribution of our or our partners’ products. In addition, new laws and regulations to which we and our customers and partners are subject may change in the future affecting the viability of market entry for new products developed in our EVT Innovate segment or the ability to continue certain projects in our EVT Execute segment that may consequently be terminated at an early stage.

Parts of our operations are subject to GMP, Good Laboratory Practice (“GLP”) and Good Clinical Practice (“GCP”) requirements and similar foreign requirements. Regulatory authorities and our customers may conduct scheduled or unscheduled (for cause) periodic inspections of our facilities to monitor our quality control system and verify that it complies with regulatory requirements and with the terms of our quality agreements with our customers. Audit findings that are classified as “critical” may lead to a loss of certification with regulatory agencies or a loss of approved supplier status with our customers and a subsequent loss in revenue.

In addition, compliance failures could expose us to contractual or product liability claims, contractual claims from our customers or partners, including claims for reimbursement for lost or damaged active pharmaceutical ingredients, as well as ongoing remediation and increased compliance costs, any or all of which could be significant.

Moreover, any determination that any negligence or non-compliance with applicable laws and regulations resulted in harm to the health of the patient subject to the clinical trial or to whom the commercial drug is administered, could result in criminal, civil and administrative penalties.

We are also subject to a variety of local, state, federal, international and transnational laws and regulations that govern, among other things, (i) the importation and exportation of products (including human biological materials), (ii) the handling, transportation and manufacture of substances that could be classified as hazardous or controlled drugs, and (iii) our business practices in the United States and Europe, including through anti-corruption and anti-competition laws. Any non-compliance by us with applicable laws and regulations or the failure to maintain, renew or obtain necessary permits and licenses could result in criminal, civil and administrative penalties and could have an adverse effect on our results of operations.

Additionally, jurisdictions in which we operate may enact new laws or regulations in the future that would negatively affect our business and results of operations. For example, the European Union is considering

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the “Artificial Intelligence Act” which seeks to regulate the use of AI technologies. The act is in the early stages of the legislative process and while there is a chance its terms may have an impact on the AI/ML technologies underlying our EVOpanHunter offering, it is too early to predict to what extent, if at all, its passage might impact our operations.

Because we and our suppliers are subject to environmental, health and safety laws and regulations as well as supply chain due diligence laws, we may become exposed to liability and substantial expenses in connection with human rights and environmental compliance or remediation activities.

Our operations, including our research, development, testing and manufacturing activities are subject to numerous environmental, health and safety laws and regulations. These laws and regulations govern, among other things, the controlled use, handling, release and disposal of, and the maintenance of a registry for, hazardous materials and biological materials. Our operations involve the use of hazardous and flammable materials, including chemicals and biological materials. Our operations also produce hazardous waste products. We generally contract with third parties for the disposal of these materials and wastes. In the event of contamination or injury resulting from the use of hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties for failure to comply with such laws and regulations.

Based on the recently adopted German Supply Chain Due Diligence Act (Gesetz über die unternehmerischen Sorgfaltspflichten zur Vermeidung von Menschenrechtsverletzungen in Lieferketten), which could become effective with respect to Evotec as early as January 1, 2023, but in any event by 2024, we will be obliged to, among others, conduct human rights and environmental due diligence in our own entities as well as in respect to our direct and indirect suppliers, to establish a risk management system and to fulfil record keeping and reporting duties. Due diligence duties encompass (amongst other things) conducting annual risk assessments and third-party due diligence as well as establishing grievance and remediation mechanisms. In case of non-compliance the German Supply Chain Due Diligence Act provides for the imposition of administrative fines of up to two percent of the average annual revenues and, until proof of self-cleaning, the exclusion from public procurement. In line with general German tort law provisions civil liability could arise. Similar supply chain due diligence legislation that would be applicable to us is projected at the EU level.

Environmental, health and safety laws and regulations as well as supply chain laws are becoming more stringent. We may be required to incur substantial expenses in connection with future human rights and environmental compliance or remediation activities, in which case, our production and development efforts may be interrupted or delayed and our financial condition and results of operations may be materially adversely affected.

If we fail to comply with certain healthcare laws, including fraud and abuse laws, we could face substantial penalties and our business, results of operations, financial condition and prospects could be adversely affected.

Even though we do not bill directly to Medicare, Medicaid or other third-party payors, certain federal and state healthcare laws and regulations pertaining to fraud and abuse are and will be applicable to our business activities and the activities of our customers. We could be subject to healthcare fraud and abuse laws of both the federal government and the states in which we conduct our business. Because of the breadth of these laws and the narrowness of available statutory and regulatory exceptions, it is possible that some of our business activities could be subject to challenge under one or more of such laws. If we or our operations are found to be in violation of any of these laws or any other governmental regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines, imprisonment and the curtailment or restructuring of our operations, which could materially adversely affect our ability to operate our business and our financial results.

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We are in the process of engaging a new auditor, the timing of which is uncertain.

On June 15, 2021, the Supervisory Board engaged Ernst & Young GmbH Wirtschaftsprüfungsgesellschaft (EY) as the statutory auditor, based on the resolution of the June 15, 2021 Annual General Meeting, to audit the consolidated financial statements as of December 31, 2021, and the group management report. On June 18, 2021, EY was also appointed the Company’s independent registered public accounting firm. On September 30, 2021, EY notified the Company that EY had determined, based on a ruling by the German Auditor Oversight Body (Abschlussprüferaufsichtsstelle, APAS), that EY would not be independent for German statutory purposes for the year ended December 31, 2021. APAS has ruled that PCAOB audit services for the Company’s U.S. initial public offering represent non-audit services for purposes of German statutory independence and thus are subject to a fee cap. As EY’s fees for services related to the U.S. initial public offering are expected to exceed the fee cap, EY would not be independent for purposes of the German statutory audit for the fiscal year ended December 31, 2021. As a result, as of and for the year ended December 31, 2021, we have decided to engage a new independent registered public accounting firm and have recently started the necessary court process in Germany to effect the replacement of EY as statutory auditor, which will coincide with EY’s resignation.

We are in the process of engaging a new auditor, the timing of which is uncertain due to complex judicial procedures for appointing a statutory auditor in these circumstances under German law. Transitioning to a new auditor will require substantial time and attention from our management, including accounting and finance personnel. The transition could require even more resources if we are unable to timely engage a new firm and begin the transition. Any delay or difficulties encountered in connection with engaging and transitioning to working with a new auditor could result in our inability to timely comply with our periodic filing requirements, including our statutory financial statements and our first annual report on Form 20-F.

Risks Related to this Offering and Our Ordinary Shares

An active trading market for the ADSs may not develop.

As of the date of this prospectus, there is no public market on a U.S. national securities exchange for our ordinary shares or ADSs representing our ordinary shares. The initial public offering price for the ADSs was determined through negotiations with the underwriters. Although we have applied to list the ADSs on the Nasdaq Global Select Market, an active trading market for the ADSs may never develop or be sustained following this offering. If an active market for the ADSs does not develop, it may be difficult for you to sell ADSs you purchase in this offering without depressing the market price for the ADSs, or at all.

The price of our ADSs may be volatile and fluctuate due to factors beyond our control.

The price of the securities of publicly traded pharmaceutical and biotechnology and drug discovery and development companies has been highly volatile and is likely to remain highly volatile in the future. The market price of our ADSs may fluctuate significantly due to a variety of factors, including the following:

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These and other industry and market factors may cause the market price and demand for our securities to fluctuate substantially, regardless of our actual operating performance, which may limit or prevent investors from readily selling their ADSs and may otherwise negatively affect the liquidity of the ADSs. In addition, the stock market in general, and pharmaceutical and biotechnology companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies.

If you purchase ADSs in this offering, you will incur immediate and substantial dilution in the book value of your investment.

You will incur immediate and substantial dilution in the net tangible book value of the ADSs if you purchase ADSs in this offering. Based on an assumed initial public offering price of $                per ADS, which is the midpoint of the price range set forth on the cover page of this prospectus, after giving effect to this offering, purchasers of ADSs in this offering will experience immediate dilution in net tangible book value of $                per ADS. In addition, after giving effect to this offering, investors purchasing ADSs in this offering will contribute        % of the total amount invested by shareholders since inception but will only own        % of the ordinary shares outstanding. See “Dilution” for a more detailed description of the dilution to new investors in the offering.

Raising additional capital may cause dilution to our existing shareholders or restrict our operations.

We may seek additional capital from time to time through a combination of equity offerings and debt financings. To the extent that we raise additional capital through the sale of equity securities, including securities convertible or exchangeable into ordinary shares, your ownership interest will be diluted and the terms may include liquidation or other preferences that adversely affect your rights as a holder of ADSs. The incurrence of indebtedness would result in increased fixed payment obligations and could involve restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business.

We are an “emerging growth company” and the reduced disclosure requirements applicable to emerging growth companies may make our ordinary shares and the ADSs less attractive to investors.

We are an “emerging growth company” under the JOBS Act, and we will remain an emerging growth company until the earlier of:

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For so long as we continue to be an emerging growth company, we are permitted and intend to rely on exemptions from certain disclosure requirements that are otherwise applicable to U.S. public companies. These exemptions include:

We may choose to take advantage of certain or all of the above available exemptions. We have taken advantage of reduced reporting burdens in this prospectus. In particular, we have not included all of the executive compensation information that would be required if we were not an emerging growth company. We cannot predict whether investors will find the ADSs less attractive if we rely on certain or all of these exemptions. If some investors find the ADSs less attractive as a result of our reliance on certain exemptions, there may be a less active trading market for the ADSs and the price per ADS may be more volatile.

In addition, the JOBS Act provides that an emerging growth company may take advantage of an extended transition period for complying with new or revised accounting standards. This allows an emerging growth company to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. Such provisions are only applicable under U.S. GAAP. As a result, we will adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required or permitted by the IASB.

As a “foreign private issuer,” we are exempt from certain rules under the U.S. securities laws, as well as Nasdaq rules, and we are permitted to file less information with the SEC than U.S. companies. This may limit the information available to holders of the ADSs and may make our ordinary shares and the ADSs less attractive to investors.

We are a “foreign private issuer,” as defined in the rules and regulations of the SEC, and, consequently, we are not subject to all of the disclosure requirements applicable to companies organized within the United States. For example, we are exempt from certain rules under the U.S. Securities Exchange Act of 1934, as amended, or the Exchange Act, that regulate disclosure obligations and procedural requirements related to the solicitation of proxies, consents or authorizations applicable to securities registered under the Exchange Act. In addition, our officers and directors are exempt from the reporting and “short-swing” profit recovery provisions of Section 16 of the Exchange Act and related rules with respect to their purchases and sales of our securities. Moreover, we are not required to file periodic reports and financial statements with the SEC as frequently or as promptly as U.S. public companies. Accordingly, there may be less publicly available information about our company than there is for U.S. public companies.

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As a foreign private issuer, we will file an annual report on Form 20-F within four months of the close of each fiscal year ending December 31 and reports on Form 6-K relating to certain material events promptly after we publicly announce these events.

As a foreign private issuer, we are permitted to follow home country practice in lieu of certain Nasdaq corporate governance requirements. We therefore intend to continue to follow German corporate governance practices in lieu of the corporate governance requirements of Nasdaq in certain respects. In particular, we intend to follow German corporate governance practices in connection with the distribution of annual and interim reports to shareholders, the holding of annual meetings, proxy solicitations in connection with shareholders’ meetings, quorum requirements, supervisory board composition, executive session scheduling, compensation committee requirements, shareholders’ vote regarding all equity compensation plans, disclosure of individual compensation for the company’s directors and management, and obtaining shareholder approval in connection with the establishment of or material amendment to certain equity-based compensation plans. We also intend to continue to follow German corporate governance practices in lieu of certain corporate governance requirements promulgated by the SEC, including procedures related to the disclosure of code of conduct and ethics waivers.

Due to the above exemptions for foreign private issuers, our shareholders will not be afforded the same protections or information generally available to investors holding shares in public companies organized in the United States. As a result, some investors may find the ADSs less attractive, and there may be a less active trading market for the ADSs. If we were to no longer qualify as a foreign private issuer we would be subject to substantial new regulations and disclosure obligations, which may lead to additional compliance costs and impact the manner in which we operate our business.

A U.S. Holder (as defined in Taxation—Material U.S. Federal Income Tax Considerations) of ADSs may suffer adverse U.S. federal income tax consequences if we are a PFIC for any taxable year.

Under the United States Internal Revenue Code of 1986, as amended, or the Code, we will be a PFIC for any taxable year in which, after the application of certain look-through rules with respect to subsidiaries, either (i) 75% or more of our gross income consists of “passive income,” or (ii) 50% or more of the average quarterly value of our assets consists of assets that produce, or are held for the production of, “passive income.” Passive income generally includes dividends, interest, certain non-active rents and royalties, and capital gains. Whether we or any of our subsidiaries will be a PFIC in 2021 or any future year is a factual determination that must be made annually at the close of each taxable year, and, thus, is subject to significant uncertainty, because among other things (i) we currently own, and may continue to own after the closing of the offering, a substantial amount of passive assets, including cash and securities that may give rise to passive income, (ii) the valuation of our assets that may generate non-passive income for PFIC purposes, including our intangible assets, is uncertain and may vary substantially over time, (iii) the treatment of grants as income for U.S. federal income tax purposes is unclear, and (iv) the composition of our income, if any, may vary substantially over time. Accordingly, there can be no assurance that we will not be a PFIC in 2021 or any future taxable year. If we are a PFIC for any taxable year during which a U.S. Holder (as defined in Taxation—Material U.S. Federal Income Tax Considerations) holds ADSs, we generally would continue to be treated as a PFIC with respect to that U.S. investor for all succeeding years during which the U.S. Holder holds ADSs even if we ceased to meet the threshold requirements for PFIC status, unless certain exceptions apply. Such a U.S. Holder may be subject to adverse U.S. federal income tax consequences, including (i) the treatment of all or a portion of any gain on disposition as ordinary income, (ii) the application of a deferred interest charge on such gain and the receipt of certain dividends and (iii) compliance with certain reporting requirements. There is no assurance that we will provide information that will enable investors to make a qualified electing fund election, also known as a QEF Election, that could mitigate the adverse U.S. federal income tax consequences should we be classified as a PFIC.

For further discussion, see “Taxation—Material U.S. Federal Income Tax Considerations.”

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U.S. investors may have difficulty enforcing civil liabilities against our company, members of our Supervisory Board and Management Board and the experts named in this prospectus.

We are incorporated under the laws of Germany as a European stock corporation (Societas Europaea) pursuant to the Council Regulation (EC) No 2157/2001 of October 8, 2001 on the Statute for a European company, or the SE Regulation; and the German Act on the Implementation of Council Regulation (EC) No 2157/2001 of October 8, 2001 on the Statute for a European company (SE) (Gesetz zur Ausführung der Verordnung (EG) NR. 2157/2001 des Rates vom 8. Oktober 2001 über das Statut der Europäischen Gesellschaft (SE) (SE-Ausführungsgesetz—SEAG). The majority of our assets are located outside the United States and all of the members of our Management Board and Supervisory Board reside outside of the United States. As a result, it may not be possible for investors to effect service of process within the United States upon such persons or to enforce against them or us in U.S. courts’ judgments predicated upon the civil liability provisions of the federal securities laws of the United States. In addition, awards of punitive damages in actions brought in the United States or elsewhere may be unenforceable in Germany. An award for monetary damages under the U.S. securities laws would be considered punitive if it does not seek to compensate the claimant for loss or damage suffered and is intended to punish the defendant. The enforceability of any judgment in Germany will depend on the particular facts of the case as well as the laws and treaties in effect at the time. There is currently no treaty between the United States and Germany providing for reciprocal recognition and enforceability of judgments rendered in civil and commercial matters, though recognition and enforcement of foreign judgments in Germany is possible in accordance with applicable German laws. Litigation in Germany is also subject to rules of procedure that differ from the U.S. rules, including with respect to the taking and admissibility of evidence, the conduct of the proceedings and the allocation of costs. Proceedings in Germany would have to be conducted in the German language, and all documents submitted to the court would, in principle, have to be translated into German. For these reasons, it may be difficult for a U.S. investor to bring an original action in a German court predicated upon the civil liability provisions of the U.S. federal securities laws against us or any members of our Management Board or Supervisory Board.

German and other non-U.S. courts may refuse to hear a U.S. securities law claim if jurisdiction cannot be established under German law. Even if a non-U.S. court agrees to hear a claim, it may determine that the law of the jurisdiction in which the court resides, and not U.S. law, is applicable to the claim. Further, even if U.S. law is found to be applicable, the content of applicable U.S. law must be proved as fact, which can be a time-consuming and costly process, and certain matters of procedure would still be governed by the law of the jurisdiction in which the foreign court resides.

For more information, please see “Service of Process and Enforcement of Liabilities.”

The rights of shareholders in a stock corporation subject to German law differ in material respects from the rights of shareholders of corporations incorporated in the United States.

We are a European stock corporation (Societas Europaea) with our registered office in Germany. Our corporate affairs are governed by the laws governing stock corporations and European stock corporations incorporated in Germany, the SE Regulation and our articles of association. The rights of shareholders may be different from the rights and obligations of shareholders in companies governed by the laws of U.S. jurisdictions. Among other differences in shareholder rights, under German law, certain important resolutions, including, for example, capital decreases, measures under the German Transformation Act (Umwandlungsgesetz), such as mergers, conversions and spin-outs and the dissolution of the German stock corporation apart from insolvency and certain other proceedings, require the vote of a 75% majority of the capital present or represented at the relevant shareholders’ meeting. Therefore, the holder or holders of a blocking minority of more than 25% or, depending on the attendance level at the shareholders’ meeting, the holder or holders of a smaller percentage of the shares in a European stock corporation may be able to block any such votes, possibly to our detriment or the detriment of other shareholders.

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As a general rule under German law, in the case of a two-tier European stock corporation, a shareholder has no direct recourse against the members of the management board and the supervisory board, in the event that it is alleged that they have breached their duty of loyalty or duty of care to the corporation. Apart from insolvency or other special circumstances, only the European stock corporation itself has the right to claim damages from members of the management and supervisory boards. A European stock corporation may waive or settle these damages claims only if at least three years have passed and the shareholders approve the waiver or settlement at the shareholders’ meeting with a simple majority of the votes cast, provided that a minority holding, in the aggregate, 10% or more of the European stock corporation’s share capital does not have its opposition formally noted in the minutes maintained by a German civil law notary.

In addition, the responsibilities of members of our Management Board and Supervisory Board may differ from the duties of directors of U.S. corporations. In the performance of their duties, our Management Board and Supervisory Board may take into account a broad range of considerations, including our interests, the interests of our shareholders, employees, creditors and, to a limited extent, the general public. It is possible that some of these parties will have interests that are different from, or in addition to, your interests as a holder of ADSs.

For more information, we have provided summaries of relevant German corporate law and of our articles of association under “Management” and “Description of Share Capital and Articles of Association (Satzung).”

We do not anticipate paying any cash dividends on our ordinary shares in the foreseeable future and, consequently, your ability to achieve a return on your investment will depend on appreciation in the price of the ADSs. If we were to pay dividends, holders of the ADSs may be unable to claim tax credits with respect to, or tax refunds to reduce German withholding tax applicable to, the payment of such dividends, or such dividends may effectively be taxed twice.

We have never paid or declared any cash dividends on our ordinary shares, and we do not anticipate paying any cash dividends on our ordinary shares in the foreseeable future. You are not likely to receive any dividends on your ADSs, and the success of an investment in ADSs will depend upon any future appreciation in its value. Investors may need to sell all or part of their holdings of ADSs after price appreciation, which may never occur, to realize any future gains on their investment. There is no guarantee that the ADSs will appreciate in value or even maintain the price at which our shareholders have purchased the ADSs.

As a German tax resident company, if we were to pay dividends, such dividends will in principle be subject to German withholding tax. Currently, the applicable German withholding tax rate is in principle 26.375% of the gross dividend. This German tax can, e.g., be reduced to the Convention between the Federal Republic of Germany and United States of America for the Avoidance of Double Taxation and the Prevention of Fiscal Evasion with respect to Taxes on Income and on Capital and Certain Other Taxes of 1989, as amended by the Protocol as of June 4, 2008 (Abkommen zwischen der Bundesrepublik Deutschland und den Vereinigten Staaten von Amerika zur Vermeidung der Doppelbesteuerung und zur Verhinderung der Steuerverkürzung auf dem Gebiet der Steuern vom Einkommen und vom Vermögen und einiger anderer Steuern in der Fassung vom 4. Juni 2008), hereinafter referred to as the “Treaty”, rate, which in the vast majority of cases should be 15%, if, among others, the applicable taxpayer is eligible for such Treaty rate and files an application supplemented by a specific German tax certificate with the German Federal Central Tax Office (Bundeszentralamt für Steuern). If such a tax certificate cannot be delivered to the ADS holder, for example due to applicable settlement mechanics or lack of information regarding the ADS holder, such holder may be unable to benefit from the double tax treaty relief and may be unable to claim a credit of withholding tax in excess of the applicable Treaty rate in its jurisdiction of residence. Further, the payment made to the ADS holder equal to the net dividend may qualify, under the tax law applicable to the ADS holder, as taxable income that is in turn subject to withholding, which could mean that a dividend is effectively taxed twice. There can be no guarantee that the information delivery requirement can be satisfied in all cases, which could result in adverse tax consequences for affected ADS

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holders. ADS holders should note that the circular issued by the German Federal Ministry of Finance (BMF-Schreiben), dated May 24, 2013 (reference number IV C 1-S2204/12/10003), as amended by the circular dated December 18, 2018 (reference number IV C 1-S2204/12/10003), in respect of the taxation of American Depositary Receipts, or ADRs, on domestic shares, or the ADR Tax Circular, is, e.g., not binding on German courts, and there is no certainty as to whether a German tax court will follow the ADR Tax Circular in determining the German tax treatment of the ADSs. In addition, the ADR Tax Circular does not include details on how an ADR program should be designed in order to, e.g., fall within the scope of application of the ADR Tax Circular. If, e.g., the ADSs were determined not to fall within the scope of application of the ADR Tax Circular, or a German tax court did not follow the ADR Tax Circular, and profit distributions made with respect to the ADSs were not treated as a dividend for German tax purposes, a holder of the ADSs might not be entitled to a refund of any taxes withheld on the dividends under German tax law and profit distributions made with respect to the ADSs may be effectively taxed twice.

The tax treatment of ADSs by German tax authorities is subject to change and might have negative implications for investment fund investors.

The specific treatment of ADSs in Germany is based on domestic German tax laws, including, but not limited to, circulars issued by German tax authorities, which, e.g., are not binding on the German courts and the Treaty (defined above). The pertinent laws are subject to change, possibly with retroactive effect. For example, tax authorities may modify their interpretation of acts of parliament and the current treatment of ADSs may change.

According to the circular issued by the German Federal Ministry of Finance (BMF-Schreiben), dated May 21, 2019 (reference number IV C 1 – S 1980-1/16/10010 :001), ADSs are not treated as capital participations (Kapitalbeteiligungen) within the meaning of Section 2 Para. 8 of the Investment Tax Code (Investmentsteuergesetz). Such interpretation by the fiscal authorities may have adverse effects e.g. on the taxation of investors which have invested in an investment fund holding ADSs.

You may not receive distributions on the ordinary shares underlying our ADSs or any value for them if it is illegal or impractical to make them available to holders of ADSs.

The depositary of our ADSs has agreed to pay to you the cash dividends or other distributions, if any, that it or the custodian receives on our ordinary shares after deducting any withholding taxes or other governmental expenses that must be paid and its fees and expenses. You will receive these distributions in proportion to the number of ordinary shares your ADSs represent. However, the depositary is not responsible if it decides that it is unlawful or impracticable to make a distribution available to any holders of ADSs. We have no obligation to take any other action to permit the distribution to ADS holders. This means that you may not receive the distributions we make on our ordinary shares or any value from them if it is unlawful or impractical for us to make them available for you. These restrictions may have a material adverse effect on the value of your ADSs.

The dual listing of our shares and the ADSs following this offering may adversely affect the liquidity and value of the ADSs.

Following this offering and after the ADSs are traded on the Nasdaq Global Select Market, our shares will continue to be listed on the Frankfurt Stock Exchange. Trading of the ADSs or shares in these markets will take place in different currencies (U.S. dollars on the Nasdaq Global Select Market and Euros on the Frankfurt Stock Exchange), and at different times (resulting from different time zones, different trading days and different public holidays in the United States and Germany). The trading prices of our shares on these two markets may differ due to these and other factors. Any decrease in the price of our shares on the Frankfurt Stock Exchange could cause a decrease in the trading price of the ADSs on the Nasdaq Global Select Market. Investors could seek to sell or buy our shares to take advantage of any price differences between the markets through a practice

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referred to as arbitrage. Any arbitrage activity could create unexpected volatility in both our share prices on one exchange, and the shares available for trading on the other exchange. In addition, holders of ADSs will not be immediately able to surrender their ADSs and withdraw the underlying shares for trading on the other market without effecting necessary procedures with the depositary. This could result in time delays and additional cost for holders of ADSs. We cannot predict the effect of this dual listing on the value of our ordinary shares and the ADSs. However, the dual listing of our shares and the ADSs may reduce the liquidity of these securities in one or both markets and may adversely affect the development of an active trading market for the ADSs in the United States. Furthermore, in connection with any distributions of payments under the deposit agreement, the depositary may convert foreign currency itself or through any of its affiliates and, in those cases, acts as principal for its own account and not as an agent, fiduciary or broker on behalf of any other person and earns revenue, including, without limitation, fees and spreads that it will retain for its own account. The depositary makes no representation that the exchange rate used or obtained in any currency conversion will be the most favorable rate that could be obtained at the time or as to the method by which that rate will be determined, subject to its obligations under the deposit agreement.

Future sales, or the perception of future sales, of a substantial number of our shares or ADSs could adversely affect the price of the ADSs, and actual sales of our equity will dilute shareholders and ADS holders.

Future sales of a substantial number of our shares or ADSs, or the perception that such sales will occur, could cause a decline in the market price of the ADSs. As of June 30, 2021, we had 164,608,236 ordinary shares issued. Shares underlying the ADSs offered in this offering may be resold in the public market immediately without restriction, unless purchased by our affiliates. If, after the period during which lock-up agreements restrict sales of the ADSs and shares, these shareholders sell substantial amounts of shares or ADSs in the public market, or the market perceives that such sales may occur, the market price of the ADSs and our ability to raise capital through an issue of equity securities in the future could be adversely affected.

Holders of the ADSs are not treated as shareholders of our company.

By participating in this offering you will become a holder of ADSs with underlying shares in a European stock corporation. Holders of the ADSs are not treated as our shareholders, unless they withdraw the shares underlying the ADSs from the depositary. The depositary is the holder of the shares underlying the ADSs. Holders of ADSs therefore do not have any rights as shareholders of our company, other than the rights that they have pursuant to the deposit agreement.

You may not be able to exercise your right to vote the shares underlying your ADSs.

Holders of ADSs may exercise voting rights with respect to the shares represented by the ADSs only in accordance with the provisions of the deposit agreement. You may instruct the depositary to vote the number of whole deposited shares your ADSs represent. The depositary will notify you of shareholders’ meetings and arrange to deliver our voting materials to you if we ask it to. Those materials will describe the matters to be voted on and explain how you may instruct the depositary how to vote. For instructions to be valid, they must reach the depositary by a date set by the depositary.

You may instruct the depositary to vote the shares underlying your ADSs. Otherwise, you will not be able to exercise your right to vote, unless you withdraw the shares underlying the ADSs you hold. We cannot assure you that you will receive the voting materials in time to ensure that you can instruct the depositary to vote your shares. In addition, the depositary and its agents are not responsible for failing to carry out voting instructions or for the manner of carrying out voting instructions provided that any such failure is in good faith. This means that you may not be able to exercise your right to vote and there may be no remedies available to you if the shares underlying your ADSs are not voted as you requested. If we do not instruct the depositary to obtain your voting instructions, you can still instruct the depositary how to vote, and the depositary may vote as you instruct, but it is not required to do so.

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Your right as a holder of ADSs to participate in any future preemptive subscription rights issues or to elect to receive dividends in shares may be limited, which may cause dilution to your holdings.

Under German law, the existing shareholders generally have a preemptive right to subscribe for shares offered in proportion to the amount of shares they hold in connection with any offering of shares. However, a shareholders’ meeting may vote, by a majority, which represents at least three quarters of the share capital represented at the meeting, to exclude this preemptive right provided that, from the company’s perspective, there exists good and objective cause for such exclusion.

Certain non-German shareholders may not be able to exercise their preemptive subscription rights in our future offerings due to the legislation and regulations of their home country. For example, ADS holders in the United States will not be entitled to exercise or sell such rights unless we register the rights and the securities to which the rights relate under the Securities Act or an exemption from the registration requirements is available. In addition, the deposit agreement provides that the depositary need not make rights available to you unless the distribution to ADS holders of both the rights and any related securities are either registered under the Securities Act or exempted from registration under the Securities Act. We are under no obligation to file a registration statement with respect to any such rights or securities or to endeavor to cause such a registration statement to be declared effective. Moreover, we may not be able to establish an exemption from registration under the Securities Act. Accordingly, ADS holders may be unable to participate in our rights offerings and may experience dilution in their holdings. In addition, if the depositary is unable to sell rights that are not exercised or not distributed or if the sale is not lawful or reasonably practicable, it will allow the rights to lapse, in which case you will receive no value for these rights.

You may be subject to limitations on transfers of your ADSs.

Your ADSs are transferable on the books of the depositary. However, the depositary may close its transfer books at any time or from time to time when it deems expedient in connection with the performance of its duties. In addition, the depositary may refuse to deliver, transfer or register transfers of ADSs generally when our books or the books of the depositary are closed, or at any time if we or the depositary deems it advisable to do so because of any requirement of law or of any government or governmental body, or under any provision of the deposit agreement, or for any other reason.

We have broad discretion in the use of the net proceeds from this offering and may not use them effectively.

Our management will have broad discretion in the application of the net proceeds that we receive from this offering, including applications for working capital, possible acquisitions and other general corporate purposes, and we may spend or invest these proceeds in a way with which our shareholders disagree. The failure by our management to apply these funds effectively could harm our business and financial condition. Pending their use, we may invest the net proceeds from this offering in a manner that does not produce income or that loses value. These investments may not yield a favorable return to our investors.

General Risks

We will incur increased costs and demands upon management as a result of being a public company listed in the United States.

As a public company listed in the United States, we will incur significant additional legal, accounting and other costs. These additional costs could negatively affect our financial results. In addition, changing laws, regulations and standards relating to corporate governance and public disclosure, including regulations implemented by the SEC and the Nasdaq Global Select Market, may increase legal and financial compliance costs and make some activities more time-consuming. These laws, regulations and standards are subject to varying interpretations and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies.

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We intend to invest resources to comply with evolving laws, regulations and standards, and this investment may result in increased general and administrative expenses and a diversion of management’s time and attention from revenue-generating activities to compliance activities. If notwithstanding our efforts to comply with new laws, regulations and standards, we fail to comply, regulatory authorities may initiate legal proceedings against us and our business may be harmed.

Failure to comply with these rules might also make it more difficult for us to obtain some types of insurance, including directors’ and officers’ liability insurance, and we might be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage.

If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, shareholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our shares.

Effective internal controls over financial reporting are necessary for us to provide reliable financial reports and, together with adequate disclosure controls and procedures, are designed to prevent fraud. Any failure to implement required new or improved controls, or difficulties encountered in their implementation could cause us to fail to meet our reporting obligations. In addition, any testing by us conducted in connection with Section 404 of the Sarbanes-Oxley Act of 2002, or any subsequent testing by our independent registered public accounting firm, may reveal deficiencies in our internal controls over financial reporting that are deemed to be material weaknesses or that may require prospective or retroactive changes to our financial statements, or identify other areas for further attention or improvement. Inferior internal controls could also cause investors to lose confidence in our reported financial information, which could have a negative effect on the trading price of our shares.

For as long as we are an “emerging growth company” under the JOBS Act, our independent registered public accounting firm will not be required to attest to the effectiveness of our internal controls over financial reporting pursuant to Section 404. We may lose our emerging growth status as soon as the end of 2022. An independent assessment of the effectiveness of our internal controls could detect problems that our management’s assessment might not. Undetected material weaknesses in our internal controls could lead to financial statement restatements and require us to incur the expense of remediation.

Our employees, independent contractors, principal investigators, CROs, consultants, vendors and partnership partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.

We are exposed to the risk that our employees, independent contractors, principal investigators, CROs, consultants, vendors and partnership partners may engage in fraudulent conduct or other illegal activities. Misconduct by these parties could include intentional, reckless and negligent conduct or unauthorized activities that violate, among other things: (i) the legal requirements or other requirements of the EMA, the FDA and comparable authorities, including those laws that require the reporting of true, complete and accurate information to such authorities; (ii) manufacturing standards; (iii) data privacy, security, fraud and abuse and other healthcare laws and regulations; or (iv) laws that require the reporting of true, complete and accurate financial information and data.

There is no certainty that all of our employees, agents, contractors, or partners, or those of our affiliates, will comply with all applicable laws and regulations, particularly given the high level of complexity of these laws. It is not always possible to identify and deter misconduct by employees and other third-parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with such laws or regulations. Additionally, we are subject to the risk that a person could allege such fraud or other misconduct, even if none occurred. If any such actions are instituted against us, and we are

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not successful in defending ourselves or asserting our rights, those actions could result in significant administrative, civil and criminal fines and sanctions against us, our officers, or our employees, the closing down of our facilities, requirements to obtain export licenses, cessation of business activities in sanctioned countries, exclusion from participation in federal healthcare programs including Medicare and Medicaid, implementation of compliance programs, integrity oversight and reporting obligations, and prohibitions on the conduct of our business. Any such violations could include prohibitions on our ability to offer our partners’ products in one or more countries and could materially damage our reputation, our brand, our international expansion efforts, our ability to attract and retain employees, and our business, prospects, operating results and financial condition.

Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements could adversely affect our business, results of operations, and financial condition. We receive and store increasing volumes of sensitive information, such as employee, personal and pseudonymized patient data as well as human biological materials. We are subject to a variety of local, state, national and international laws, directives and regulations that apply to the collection, use, storage, retention, protection, disclosure, transfer and other processing of personal data, collectively referred to as “data processing”, in the different jurisdictions in which we operate, including comprehensive regulatory systems in the United States and Europe. Legal requirements relating to data processing continue to evolve and may result in ever-increasing public scrutiny and escalating levels of enforcement, sanctions and increased costs of compliance.

As our operations and business grow, we may become subject to or affected by new or additional data protection laws and regulations and face increased scrutiny or attention from regulatory authorities. In the United States, HIPAA imposes, among other things, certain standards relating to the privacy, security, transmission and breach reporting of individually identifiable health information. Certain states have also adopted comparable privacy and security laws and regulations, some of which may be more stringent than HIPAA. Such laws and regulations will be subject to interpretation by various courts and other governmental authorities, thus creating potentially complex compliance issues for us and our future customers and strategic partners. Further, many state legislatures have adopted legislation that regulates how businesses operate online, including measures relating to privacy, data security and data breaches. Laws in all 50 states require businesses to provide notice to customers whose personally identifiable information has been disclosed as a result of a data breach. The laws are not consistent, and compliance in the event of a widespread data breach is costly. States are also constantly amending existing laws, requiring attention to frequently changing regulatory requirements. For example, the California Consumer Privacy Act of 2018 (“CCPA”), went into effect on January 1, 2020. The CCPA creates individual privacy rights for California consumers and increases the privacy and security obligations of entities handling certain personal information. The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches that is expected to increase data breach litigation. The CCPA may increase our compliance costs and potential liability, and many similar laws have been proposed at the federal level and in other states. Further, the California Privacy Rights Act (“CPRA”), recently passed in California. The CPRA will impose additional data protection obligations on covered businesses, including additional consumer rights processes, limitations on data uses, new audit requirements for higher risk data, and opt outs for certain uses of sensitive data. It will also create a new California data protection agency authorized to issue substantive regulations and could result in increased privacy and information security enforcement. The majority of the provisions will go into effect on January 1, 2023, and additional compliance investment and potential business process changes may be required. In the event that we are subject to or affected by HIPAA, the CCPA, the CPRA or other domestic privacy and data protection laws, any liability from failure to comply with the requirements of these laws could adversely affect our financial condition.

In the European Union, the GDPR went into effect in May 2018. The GDPR has far-reaching extraterritorial effect so that it applies to, amongst others, any business, regardless of its location, that processes personal data of EEA residents in relation to offering goods or services to such EEA residents. The GDPR imposes strict requirements on controllers and processors of personal data, including special protections for “special categories of personal data” which includes health and genetic information of data subjects residing in

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the EEA. Under the GDPR, subjects of data processing are entitled to obtain from the controller a range of information related to the data processing activities, as well as to be informed of safeguards regarding the international transfer of data and to request a copy of all data being process related to that subject. The GDPR also imposes strict rules on the transfer of personal data out of the European Union to the United States and other countries. In July 2020, the Court of Justice of the European Union, or the CJEU, limited how organizations could lawfully transfer personal data from the European Union to the United States by invalidating the EU-US Privacy Shield Framework for purposes of international transfers and imposing further restrictions on use of the standard contractual clauses, or SCCs. These restrictions include a requirement for companies to carry out a transfer impact assessment which, among other things, assesses the laws governing access to personal data in the recipient country and considers whether supplementary measures that provide privacy protections additional to those provided under SCCs will need to be implemented to ensure an essentially equivalent level of data protection to that afforded in the European Union. The European Commission issued revised SCCs on June 4, 2021 to account for the decision of the CJEU and recommendations made by the European Data Protection Board. As supervisory authorities issue further guidance on personal data export mechanisms, including circumstances where the SCCs cannot be used, and/or start taking enforcement action, we could suffer additional costs, complaints and/or regulatory investigations or fines, and/or if we are otherwise unable to transfer personal data between and among countries and regions in which we operate, it could affect the manner in which we provide our services, the geographical location or segregation of our relevant systems and operations, and could adversely affect our financial results. In addition, the GDPR provides that European Union member states may make their own local further laws and regulations limiting the processing of personal data, including genetic, biometric or health data.

We are subject to the GDPR because we are located in the EEA. Additionally, as the GDPR applies extraterritorially, we are also subject to the GDPR even where our data processing activities occur outside of the EEA if such activities involve the personal data of individuals located in the EEA. GDPR regulations have imposed additional responsibility and liability in relation to the personal data that we process and we may be required to put in place additional mechanisms to ensure compliance with the new data protection rules. If we fail to comply with the GDPR and the applicable national data protection laws of the European Union member states, or if regulators assert we have failed to comply with these laws, it may lead to regulatory enforcement actions or other administrative penalties, including but not limited to monetary penalties of up to €20,000,000 or up to 4% of our total worldwide annual turnover of the preceding financial year, whichever amount is higher. This may be onerous and may interrupt or delay our development activities, and adversely affect our business, financial condition and results of operations.

Further, from January 1, 2021, we have to comply with the GDPR and also the UK GDPR, which, together with the amended UK Data Protection Act 2018, retains GDPR in United Kingdom national law. The UK GDPR mirrors the potential administrative fines under the GDPR, i.e., it provides for fines up to the greater of £17.5 million or 4% of global turnover. The European Commission has adopted an adequacy decision in favor of the United Kingdom, enabling data transfers from EU member states to the United Kingdom without additional safeguards. However, the United Kingdom adequacy decision will automatically expire in June 2025 unless the European Commission re-assesses and renews/extends that decision. The relationship between the United Kingdom and the European Union in relation to certain aspects of data protection law remains unclear, and it is unclear how United Kingdom data protection laws and regulations will develop in the medium to longer term, and how data transfers to and from the United Kingdom will be regulated in the long term. These changes may lead to additional costs and increase our overall risk exposure.

Other jurisdictions outside the European Union are similarly introducing new or enhancing existing privacy and data security laws, rules and regulations, which could increase our compliance costs and the risks associated with non-compliance. Privacy and data security laws are rapidly evolving and the future interpretation of those laws is somewhat uncertain. We cannot guarantee that we are, or will be, in compliance with all applicable international regulations as they are enforced now or as they evolve. For example, our privacy policies may be insufficient to protect any personal information we collect, or may not comply with applicable laws, in

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which case we may be subject to regulatory enforcement actions, lawsuits or reputational damage, all of which may adversely affect our business. There is significant uncertainty related to the manner in which data protection authorities will seek to enforce compliance with privacy and data security laws, including the GDPR. Enforcement uncertainty and the costs associated with ensuring compliance with privacy and data security laws, including the GDPR may be onerous and adversely affect our business, financial condition, results of operations and prospects. If any of these events were to occur, our business and financial results could be significantly disrupted and adversely affected.

We may be subject to product liability claims.

We may be responsible for product liability stemming from product research, development or manufacturing, and we may face an even greater risk if any drug candidate that we develop is commercialized. If we cannot successfully defend ourselves against claims that drug products we develop with our partners caused injuries, we could incur substantial liabilities. Regardless of the merit or eventual outcome of such claims, any liability claims may result in:

We are covered by liability insurance, but notwithstanding such coverage, our financial position or results could be negatively affected by product liability claims. On occasion, large judgments have been awarded in class action lawsuits based on drugs or medical treatments that had unanticipated adverse effects. A product liability claim or series of claims brought against us could cause the price of the ADSs to decline and, if judgments exceed our insurance coverage, could adversely affect our results of operations and business.

After the completion of the offering, we may be at an increased risk of securities class action litigation.

Historically, securities class action litigation has often been brought against a company following a decline in the market price of its securities. This risk is especially relevant for us because pharmaceutical and biotechnology companies have experienced significant share price volatility in recent years. If we were to be sued, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business.

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