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Risks

• Factors outside of our control make it more difficult for VASCEPA to achieve a level of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary to meet expectations for commercial success.
• The scale and scope of the COVID-19 pandemic is uncertain and poses a significant threat to public health and infrastructure throughout the world, which could have a negative impact on our business.
• Our current and planned commercialization efforts may not be successful in increasing sales of VASCEPA in the United States.
• * Our promotion of VASCEPA is subject to regulatory scrutiny and associated risk generally.
• As generic company competitors seek to compete with copies of VASCEPA in the United States and elsewhere we could face additional challenges to our patents and additional patent litigation.
• VASCEPA is a prescription-only omega-3 fatty acid product. Omega-3 fatty acids are also marketed by other companies as non-prescription dietary supplements. As a result, in the U.S. VASCEPA is subject to non-prescription competition and consumer substitution.
• Our products and marketing efforts are subject to extensive post-approval government regulation.
• Legislative or regulatory reform of the healthcare system in the United States and foreign jurisdictions may affect our ability to profitably sell VASCEPA.
• If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
• Changes in reimbursement procedures by government and other third-party payors may limit our ability to market and sell our approved drugs. These changes could have a material adverse effect on our business and financial condition.
• Ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations.
• Failure to comply with health and data protection laws and regulations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation, and/or adverse publicity and could negatively affect our operating results and business.
• * The U.S. FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription products and promotional efforts such as speaker programs. If we or our partners are found to have improperly promoted uses, efficacy or safety of VASCEPA or otherwise are found to have violated the law or applicable regulations, we may become subject to significant fines and other liability. The government may seek to find means to prevent our promotion of truthful and non-misleading information beyond the current court ruling and litigation settlement or seek to find violations of other laws or regulations in connection with the promotional efforts we undertake on our own or through third parties.
• As we continue to build our infrastructure for commercializing VASCEPA, we may encounter difficulties in managing our growth and expanding our operations successfully.
• Our supply of product for the commercial market and clinical trials is dependent upon relationships with third-party manufacturers and suppliers.
• We may purchase too much or not enough supply to satisfy actual demand, which could have a material adverse effect on our financial results and financial condition.
• Our dependence on third parties in the distribution channel from our manufacturers to patients subject us to risks that limit our profitability and could limit our ability to supply VASCEPA to large market segments.
• Our commercialization of VASCEPA outside the United States is substantially dependent on third parties and other circumstances outside our control.
• * Our relationships with healthcare providers and physicians and third-party payors are subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose use to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
• We rely on third parties to conduct our clinical trials, and those third parties may not perform satisfactorily, including failing to meet established deadlines for the completion of such clinical trials.
• We are dependent on patents, proprietary rights and confidentiality to protect the commercial potential of VASCEPA.
• Our issued patents may not prevent competitors from competing with VASCEPA, even if we seek to enforce our patent rights.
• There can be no assurance that any of our pending patent applications relating to VASCEPA or its use will issue as patents.
• Despite the use of confidentiality agreements and/or proprietary rights agreements, which themselves may be of limited effectiveness, it may be difficult for us to protect our trade secrets.
• If the estimates we make, or the assumptions on which we rely, in preparing our projected guidance prove inaccurate, our actual results may vary from those reflected in our projections and accruals.
• * The loss of key personnel could have an adverse effect on our business, particularly in light of our recent announcement of management succession plan.
• We are subject to potential product liability.
• A change in our tax residence could have a negative effect on our future profitability.
• We could be adversely affected by our exposure to customer concentration risk.
• Although we began generating revenue from VASCEPA in January 2013, we may never be profitable for a full year.
• Our operating results are unpredictable and may fluctuate. If our operating results are below the expectations of securities analysts or investors, the trading price of our stock could decline.
• We may require substantial additional resources to fund our operations. If we cannot find additional capital resources, we will have difficulty in operating as a going concern and growing our business.
• Actual or potential sales of our common shares by our employees, including members of our senior management team, pursuant to pre-arranged stock trading plans could cause our stock price to fall or prevent it from increasing for numerous reasons, and actual or potential sales by such persons could be viewed negatively by other investors.
• If we were to be characterized as a passive foreign investment company there could be adverse consequences to U.S. investors.
• The rights of our shareholders may differ from the rights typically offered to shareholders of a U.S. corporation.
• Shareholder protections found in provisions under the UK City Code on Takeovers and Mergers, or the Takeover Code, do not apply to us.
• U.S. holders of the ADSs or ordinary shares may be subject to U.S. federal income taxation at ordinary income tax rates on undistributed earnings and profits.
• Potential technological changes in our field of business create considerable uncertainty.
• Legal, political and economic uncertainty surrounding the exit of the UK from the EU may be a source of instability in international markets, create significant currency fluctuations, adversely affect our operations in the UK and pose additional risks to our business, revenue, financial condition, and results of operations.
• Negative economic conditions would likely have a negative effect on our ability to obtain financing on acceptable terms.
• Raising additional capital may cause dilution to our existing shareholders, restrict our operations or require us to relinquish rights.
• Potential business combinations or other strategic transactions may disrupt our business or divert management’s attention.