Summary Risk Factors

Our ability to implement our business strategy is subject to numerous risks that you should be aware of before making an investment decision. These risks are described more fully below. These risks include, among others:

• The commercial success of our products and product candidates, including in new indications or methods of administration, will depend on the degree of market acceptance.
• We face significant competition for our drug discovery and development efforts.
• We will face significant challenges in successfully commercializing our products and additional product candidates after they are launched.
• Our products and product candidates for which we have obtained or intend to seek approval as biological products, including for new indications, may face biosimilar competition.
• Enacted and future legislation could impact demand for our products which could impact our business and future results of operations.
• We are subject to government pricing laws, regulation and enforcement. These laws affect the prices we may charge the government for our products and the reimbursement our customers may obtain from the government. Our failure to comply with these laws could harm our results, operations and/or financial conditions.
• We may not obtain or maintain adequate pricing and coverage or reimbursement status for our products and product candidates.
• If we fail to obtain orphan drug designation or we do not have valid and enforceable patents covering our products and their uses and product candidates and fail to obtain and/or maintain orphan drug exclusivity for our products or product candidates, our competitors may be able to sell products to treat the same conditions and our revenue may be reduced.
• Failure to successfully identify, select and develop our products in other indications, or additional products or product candidates could impair our ability to grow.
• Failure to successfully develop or obtain marketing approval for our products and product candidates could negatively impact our business.
• Certain of our clinical trials have not succeeded, and may in the future also not succeed, and even if they succeed, we may not obtain regulatory approval for our products or product candidates or regulatory approval may be delayed.
• If we decide to pursue accelerated approval for any of our product candidates, it may not lead to faster development or regulatory review or approval and we may still need to conduct additional clinical trials, which could increase the expense of obtaining, if at all, necessary marketing approvals.
• Our products and product candidates may have serious adverse, undesirable or unacceptable side effects, and we or others may identify undesirable or unacceptable side effects caused by any of our products or product candidates before and after they have received marketing approval.
• If our target patient population is smaller than expected, we are unable to successfully enroll and retain patients in our clinical trials, or experience significant delays in doing so, we may not realize the full commercial potential of any products or product candidates.
• We rely, and expect to continue to rely, on third parties to conduct some of our research activities and clinical trials and for parts of the development and commercialization of our existing and future research programs, products and product candidates. If our relationships with such third parties are not successful, our business may be adversely affected.
• Disruptions caused by our reliance on third parties for our manufacturing process may delay or disrupt our business, product development and commercialization efforts.
• Accuracy and timing of our financial reporting is partially dependent on information received from third-party partners, which we do not control.
• We and our third-party manufacturers and suppliers may become exposed to liability, fines, penalties or other sanctions and substantial expenses in connection with environmental compliance or remediation activities.
• We are subject to healthcare laws, regulation and potential enforcement. The failure to comply with these laws could harm our results, operations and/or financial conditions.
• Our performance tracked by our Environmental, Social and Governance metrics is subject to risks and the outcomes may not achieve the anticipated benefits or align with new regulations and stakeholders’ expectations.
• We expect to increase our expenses for the foreseeable future, and we may not be able to raise additional capital, be profitable or sustain net profitability in the future in order to fund our operations.
• We may become exposed to costly and damaging liability claims and other litigation.
• Our business and operations could suffer in the event of system failures or unauthorized or inappropriate use of or access to our systems.
• We are highly dependent on public perception of our products.
• We may be unable to adequately maintain, enforce or protect our intellectual property rights in products, product candidates and platform technologies which could adversely affect our ability to maximize the value for patients in our marketed products and product candidates.
• Intellectual property litigation could lead to substantial resource diversion or issued patents could be found invalid, not infringed, or unenforceable if challenged in the applicable patent office or court.
• Our future growth and ability to compete depends on maintaining our culture, retaining our key personnel and recruiting additional qualified personnel.
• Global geo- and socio-political threats and macro-economic uncertainty and other unforeseen political crises could materially and adversely affect our business and financial performance.
• Holders of our ADSs have fewer rights than our ordinary shareholders.
• The price of our ADSs may be volatile and may fluctuate due to factors beyond our control. An active public trading market may not be sustained.
• Claims of U.S. civil liabilities may not be enforceable against us or the members of our Senior Management Team and our Board of Directors.
• As a foreign private issuer, we are exempt from various rules and regulations that a U.S. domestic public company would be required to follow, including those requirements under U.S. securities laws and Nasdaq listing standards.
• We may lose our foreign private issuer status which would then require us to comply with the Exchange Act’s domestic reporting regime and cause us to incur significant legal, accounting and other expenses.
• If we were to be classified as a passive foreign investment company for U.S. federal income tax purposes, this could result in adverse U.S. tax consequences to certain U.S. holders.