Presbia (LENSF) Inactive Financial Report Summaries

Risks

• Risks Related to Our Business
• We anticipate that we will continue to incur significant losses for the foreseeable future and, if we are unable to achieve and sustain profitability, the market value of our ordinary shares will likely decline.
• We expect to incur substantial expenses in our pursuit of regulatory approval in the United States and can provide no assurances that we will obtain the necessary approvals from the FDA to market our products in the United States.
• Our microlens is currently our sole product and we are highly dependent on the successful marketing and sales of this product. There is no assurance that we will be able to develop any additional products.
• Our U.S. staged pivotal clinical trial may be delayed, suspended or terminated, which could delay or prohibit us from obtaining regulatory approvals or make obtaining such regulatory approvals more costly.
• If concerns regarding side effects from surgical procedures to improve near vision generally, or our products specifically, develop, including as a result of third-party studies and publications, our business, results of operations and financial condition will be materially and adversely affected.
• Adverse findings in post-marketing vigilance or regulatory audits could subject us to suspension or withdrawal of our certificates of conformity, mandatory product recalls and significant legal liability, which would materially and adversely affect our business, results of operations and financial condition.
• We have a limited operating history and may face difficulties encountered by early stage companies in new and rapidly evolving markets.
• We are engaged in an intensely competitive business with competitors that may enjoy significant competitive advantages over us and if we are unable to compete successfully against our existing or potential competitors, our sales and operating results may be negatively affected and we may not grow.
• If our microlens is approved by FDA but fails to achieve an adequate level of acceptance by ophthalmic surgeons, we will not be able to generate sufficient revenue to become or remain profitable.
• If we are unable to train ophthalmic surgeons and their clinical staff on the safe and appropriate use of our products, we may be unable to achieve revenue growth or profitability.
• Our reliance on a limited number of third-party suppliers for our microlens could harm our ability to meet demand for our products in a timely and cost effective manner.
• We rely on a single third-party supplier to supply the raw material used to manufacture our microlens.
• The global nature of our business may result in fluctuations and declines in our sales and profits.
• If we do not successfully implement our commercialization strategy, our business, results of operations and financial condition will be adversely affected.
• We do not anticipate that our microlens and the procedure to implant our microlens will be reimbursable through private or governmental third-party payors, which could limit market acceptance.
• Our ability and the ability of our subsidiaries to use net operating loss carryforwards and certain other tax attributes may be limited.
• We may seek to grow our business through acquisitions of or investments in new or complementary businesses, products or technologies, and the failure to manage any acquisitions or investments, or the failure to integrate them with our existing business, could have a material adverse effect on us.
• We may need to increase the size of our organization, and we may experience difficulties in managing growth.
• If we use biological and hazardous materials in a manner that causes injury or violates applicable laws or regulations, we could be liable for damages.
• Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
• If we experience material weaknesses in the future or otherwise fail to maintain an effective system of internal controls in the future, we may not be able to accurately report our financial condition or results of operations which may adversely affect investor confidence in us and, as a result, the value of our ordinary shares.
• We are incurring significant costs as a result of being a public company, which may adversely affect our operating results and financial condition.
• Fluctuations in insurance cost and availability could adversely affect our profitability or our risk management profile.
• Risks Related to our Regulatory Requirements
• Our products are subject to extensive governmental regulation both in the U.S. and in other countries, and our failure to comply with applicable requirements could cause our business to suffer.
• We are subject to complex regulations which have tended to become more stringent over time. Regulatory changes could result in restrictions on our ability to carry on or expand our operations, higher than anticipated costs or lower than anticipated sales.
• Modifications to our products may require new premarket approvals or notified assessments or may require us to cease marketing or recall the modified products until approvals are obtained.
• We may fail to obtain or maintain regulatory approvals or complete conformity assessment and CE marking to market our products in countries outside of the U.S.
• If we or our suppliers fail to comply with ongoing EEA and FDA or other regulatory authority requirements, or if we experience unanticipated problems with our products, these products could be subject to restrictions or withdrawal from the market.
• We rely on third parties to conduct our clinical trials and assist us with pre-clinical development. If these third parties do not perform as contractually required or expected, we may not be able to obtain regulatory clearance or approval for, or commercialize, our products.
• We may be subject to enforcement action if we engage in improper marketing or promotion of our products.
• Regulatory healthcare reforms may make it more difficult and costly for us to obtain regulatory approval or clearance of our products or complete conformity assessment and CE marking to produce, market and distribute our products after approval or clearance is obtained.
• We may become subject to third parties’ claims alleging infringement of their patents and proprietary rights or seeking to invalidate our patents or proprietary rights, or we may need to become involved in lawsuits to protect or enforce our patent portfolio, which could be costly, time consuming, delay or prevent the development and commercialization of our products, or put our patent portfolio and other proprietary rights at risk.
• Restrictions on our patent rights relating to our products may limit our ability to prevent third parties from competing against us.
• Obtaining and maintaining our patents 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.
• If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
• If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
• An active, liquid and orderly trading market for our ordinary shares may not develop and you may not be able to resell your shares at or above the price that you paid for them. No assurances can be provided that we will be able to maintain our Nasdaq listing, given that our noncompliance with Nasdaq’s minimum stockholders’ equity and minimum bid price remain unresolved.
• Our share price may be volatile, and you may not be able to resell your shares at or above the price that you paid for them.
• If securities or industry analysts do not publish or cease publishing research or reports about us, our business, or our market, or if they change their recommendations regarding our shares adversely, our share price and trading volume could decline.
• Our controlling shareholder has substantial control over us and beneficially owns a majority of our issued ordinary shares, which could delay or prevent a change in corporate control.
• We are an “emerging growth company” and we cannot be certain if the reduced disclosure requirements applicable to emerging growth companies will make our ordinary shares less attractive to investors.
• We are a “controlled company” under the Nasdaq listing rules, and as such we are entitled to exemption from certain Nasdaq corporate governance standards, and you may not have the same protections afforded to shareholders of companies that are subject to all Nasdaq corporate governance requirements.