QTNT Quotient Ltd.

Risks

• Risks Related to Our Business, Industry and Future Plans
• We have incurred losses since our commencement of operations and expect to incur losses in the future.
• We may need to raise additional capital, which may not be available on favorable terms, if at all, and which may cause dilution to shareholders, restrict our operations or adversely affect our ability to operate our business.
• If we do not achieve, sustain or successfully manage our anticipated growth, our business and prospects will be harmed.
• The development of MosaiQ includes many factors, including factors beyond our control, and we may not commercialize it on a timely basis, or at all.
• Obtaining regulatory authorization for MosaiQ will take time, require material expenditures and ultimately may not succeed.
• MosaiQ Microarrays have not been manufactured on a commercial scale and are subject to unforeseen scale-up risks.
• We cannot accurately predict the volume or timing of any future sales for MosaiQ, making the timing of any such revenues difficult to predict.
• We expect to rely on third parties to conduct studies of MosaiQ and our other transfusion diagnostics products that will be required by the FDA or other regulatory authorities and those third parties may not perform satisfactorily.
• Our commercial success will largely depend upon the degree of market acceptance of MosaiQ by donor collection agencies, hospitals and independent testing laboratories.
• Our commercialization plan for MosaiQ in the patient testing market may depend on entering into arrangements with one or more commercial partners.
• Other companies or institutions may develop and market novel or improved methods for transfusion diagnostics, which may make MosaiQ less competitive or obsolete.
• Our near-term success is dependent upon our ability to expand our customer base and introduce new conventional reagent products.
• Gross margin volatility in our conventional reagent business may negatively impact our profitability.
• If we are unable to maintain or redeploy our network of direct sales representatives, we may not be able to generate anticipated sales of our current or future products.
• We or our suppliers may experience development or manufacturing problems or delays that could limit the growth of our revenue or increase our losses.
• The transfusion diagnostics market is highly competitive. If we fail to compete effectively, our business and operating results will suffer.
• New technologies, techniques or products could emerge that might offer better combinations of price and performance than our current or future products and systems.
• We are dependent on single source suppliers for some of the components and materials used in our products, and supply chain interruptions could negatively impact our operations and financial performance.
• If any of our manufacturing facilities become unavailable or inoperable, we will be unable to produce and ship many of our products.
• We face risks related to health pandemics, epidemics and outbreaks, including the current COVID-19 pandemic, which could significantly disrupt our operations and could have a material adverse impact on us.
• Our debt and other financings contain restrictive covenants and other provisions that may limit our operating flexibility.
• Undetected errors or defects in our products could expose us to product liability claims, harm our reputation or decrease market acceptance of our products.
• We could experience a breach in the confidentiality of the information we hold or of the security of our computer systems and any failure to comply with the applicable privacy laws to which we are subject could result in losses.
• The outcome of any current or future disputes, claims, arbitration and litigation could have a material adverse effect on our business, financial condition and results of operations.
• We are highly dependent on our senior management team and other key employees, and our success depends on our ability to retain our managerial personnel and to attract additional personnel.
• We may enter into collaborations, in-licensing arrangements, joint ventures, strategic alliances or partnerships with third parties that may not result in the development of commercially viable products or the generation of significant future revenues.
• Recent global economic and political conditions could result in significant changes to legislation, government policies, rules and regulations, which may have a material adverse effect on our business.
• If we, or any commercial partners we engage fail to comply with extensive foreign and domestic regulations, sales of our products in new and existing markets and the development and commercialization of any new product candidates, including MosaiQ, could be delayed or prevented.
• If we or our suppliers fail to comply with ongoing regulatory requirements, or if we experience unanticipated problems with our products, these products could be subject to restrictions or withdrawal from the market.
• Approval and/or clearance by the FDA and foreign regulatory authorities for our transfusion diagnostics products could take significant time and require significant development expenditures.
• Our use of biological and hazardous materials and wastes requires us to comply with regulatory requirements, including environmental, health and safety laws, regulations and permitting requirements and subjects us to significant costs and exposes us to potential liabilities.
• Our relationships with customers are subject to applicable anti-kickback, fraud and abuse and other domestic healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
• We are subject to the UK Bribery Act, the U.S. Foreign Corrupt Practices Act and other anti-corruption laws, as well as export control laws, customs laws, sanctions laws and other laws governing our operations. If we fail to comply with these laws, we could be subject to civil or criminal penalties, other remedial measures, and legal expenses, which could adversely affect our business, results of operations and financial condition.
• The extent to which we can protect our products and technologies through intellectual property rights that we own, acquire or license is uncertain.
• Obtaining and maintaining our patent protection depends upon 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.
• Our intellectual property rights may not be sufficient to protect our competitive position and to prevent others from manufacturing, using or selling competing products.
• MosaiQ depends on certain technologies that are licensed to us. We do not control these technologies and any loss of our rights to them could prevent us from manufacturing our products.
• We may become involved in disputes relating to our intellectual property rights, and may need to resort to litigation in order to defend and enforce our intellectual property rights.
• We may not be able to adequately protect our intellectual property outside of the United States.
• Our failure to secure trademark registrations could adversely affect our business and our ability to market our products and product candidates.
• We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
• We are eligible to be treated as a smaller reporting company and we cannot be certain that the reduced disclosure requirements applicable to smaller reporting companies will not make our ordinary shares less attractive to investors.
• The price of our ordinary shares is likely to be volatile, and purchasers of our ordinary shares could incur substantial losses.
• If securities analysts do not continue to cover our ordinary shares or publish unfavorable research or reports about our business, this may have a negative impact on the market price of our ordinary shares.
• We have never paid cash dividends and do not intend to pay cash dividends on our ordinary shares in the foreseeable future.
• We incur increased costs as a result of being a public company whose ordinary shares are publicly traded in the United States and our management must devote substantial time to public company compliance programs.
• We cannot guarantee that we will be able to satisfy the continued listing standards of The Nasdaq Global Market going forward.
• Our ordinary shares are issued under the laws of Jersey, Channel Islands, which may not provide the level of legal certainty and transparency afforded by incorporation in a United States state.
• A change in our tax residence could have a negative effect on our future profitability.
• We may be or become classified as a passive foreign investment company for U.S. federal income tax purposes, which could result in materially adverse U.S. federal income tax consequences to U.S. investors in our ordinary shares.
• U.S. withholding tax could apply to a portion of certain payments on the ordinary shares.