Amarin (AMRN) risk factors, FY2024 10-K

Other

1. 01if we are unable to meet the listing requirements of the NASDAQ Stock Market, or NASDAQ, our stock may be delisted

Risks Related to the Commercialization and Development of VASCEPA

1. 02We are substantially dependent upon VASCEPA (icosapent ethyl), its commercialization in the United States and its development, launch and commercialization in Europe and other major markets
2. 03In the United States, we compete with, and may face increasing competition from, generic drug companies and our revenues and results of operations could continue to be materially and adversely affected
3. 04We are seeking relevant pricing approvals in various countries; however, we may not be successful in obtaining such approvals in a timely manner or at all and even if successfully obtained, we may not be successful in commercializing VAZKEPA in major markets outside the United States
4. 05We have limited experience as a company in commercializing VASCEPA outside of the United States and may be unsuccessful in developing sales internationally
5. 06Our ability to generate meaningful revenues outside of the United States may be limited, including due to the strict price controls and reimbursement limitations imposed by payors outside of the United States
6. 07Government and commercial payor actions outside of the United States have affected and will continue to affect access to and sales of our products
7. 08Factors outside of our control may make it more difficult for VASCEPA to achieve market acceptance by physicians, patients, healthcare payors and others in the medical community at levels sufficient to achieve commercial success
8. 09Additional data or related interpretations that are generated or arise over time related to REDUCE-IT might not meet expectations, and the perception of REDUCE-IT results and VASCEPA revenue potential may suffer and our stock price may decline
9. 10study conduct and data quality, integrity and consistency, including aspects such as analyses regarding the placebo used in REDUCE-IT and other studies of VASCEPA and its impact, if any, on the reliability of clinical data
10. 11Analysis of data from trials of moderate-to-high doses of VASCEPA and icosapent ethyl, or a similar eicosapentaenoic acid product, could render new or adverse information on the effects of VASCEPA and its commercial and regulatory prospects
11. 12Our ORP and any similar efforts we may undertake in the future, may not be successful in mitigating risks and challenges associated with our U.S. business and establishing a more significant international footprint
12. 13The manufacture, supply and commercialization, including promotional activities, of VASCEPA is subject to regulatory scrutiny
13. 14Further, drugs in development that are expected to compete with VASCEPA if they are ultimately approved and commercialized, and the perceived safety and efficacy of such commercialized drugs or drug products, could have a negative impact on the perceived safety and efficacy of VASCEPA
14. 15We could face patent litigation related to the patents filed related to the REDUCE-IT study
15. 16We cannot predict the outcome of the pending lawsuits, any appeals, or any subsequently filed lawsuits or inter partes review
16. 17Our products and marketing efforts are subject to extensive post-approval government regulation
17. 18These and similar regulatory dynamics, including the entry of generic versions of icosapent ethyl into the market, and the potential for additional generic versions in the near term, can affect our ability to commercialize VASCEPA on commercially reasonable terms and limit the commercial value of VASCEPA
18. 19Changes 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
19. 20Ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations
20. 21the availability of capital
21. 22Failure 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
22. 23European data collection is governed by restrictive regulations governing the use, processing and cross-border transfer of personal information
23. 24We may not be successful in developing and receiving regulatory approval for VASCEPA in other jurisdictions or marketing future products if we cannot meet the extensive regulatory requirements of regulatory agencies such as for quality, safety, efficacy and data privacy
24. 25political instability or other social or government protocols affecting our clinical trial sites
25. 26As we continue to scale our infrastructure for commercializing VASCEPA based on market dynamics for VASCEPA in the United States and commercial initiatives and plans for VAZKEPA in Europe and other parts of the world, we may encounter difficulties in managing the size and adaptability of our operations successfully
26. 27do not have a sales team to promote VASCEPA to physicians and other healthcare professionals in the U.S., and will rely on only our managed care and trade organization to support sales of VASCEPA in the U.S.
27. 28Our business is depending on successful life-cycle management efforts

Risks Related to Our Reliance on Third Parties

1. 29Our supply of product for the commercial market and clinical trials is dependent upon relationships with third-party manufacturers and suppliers, including manufacturers and suppliers who may require us to comply with burdensome minimum purchase commitments, which may be greater than our supply needs
2. 30If our third-party manufacturing capacity is not appropriately qualified and/or compliant with applicable regulatory requirements, we may not be able to supply sufficient quantities of VASCEPA to meet anticipated demand
3. 31Our 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
4. 32There are comparable foreign requirements under ICH guidelines
5. 33If Edding, Biologix, HLS, CSL, Lotus, Neopharm or Vianex, or other third parties who we rely on for development and commercialization of VASCEPA, do not successfully carry out their contractual obligations or meet expected deadlines, our recourse and remedies against these parties is limited
6. 34We 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

Risks Related to Our Intellectual Property

1. 35We have pending patent applications relating to VASCEPA and its use. There can be no assurance that any of these applications will issue patents, and even if patent protection is obtained, it may be insufficient to minimize competition or support our commercialization efforts
2. 36Despite 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

Risks Related to Our Business

1. 37If 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
2. 38The loss of key personnel could have an adverse effect on our business, particularly in light of recent senior management changes
3. 39Our internal computer systems, or those of our third‑party clinical research organizations or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our commercial, research and development and other programs
4. 40We are subject to the potential risk of product liability claims relating to the manufacturing and marketing of VASCEPA. Any person who is injured as a result of using VASCEPA may have a product liability claim against us without having to prove that we were at fault
5. 41Securities 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 due to our current stock price, as well as general market volatility experienced in recent years
6. 42A change in our tax residence and/or tax laws could have a negative effect on our future profitability
7. 43We could be adversely affected by our exposure to customer concentration risk

Risks Related to Our Financial Position and Capital Requirements

1. 44We have a history of operating losses and anticipate that we will incur continued losses for an indefinite period of time
2. 45We may never generate sufficient revenue to achieve a steady state of profitability
3. 46Our 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
4. 47We 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
5. 48In order to fully realize the market potential of VASCEPA, we may need to enter into a new strategic collaboration or raise additional capital
6. 49the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights
7. 50Changes in tax laws could have a material adverse effect on our business, financial condition and results of operations

Risks Related to Ownership of our ADSs and Common Shares

1. 51Our efforts to return capital to our shareholders and increase shareholder value, including our share repurchase program, may not be implemented in a timely manner or at all, or may not have the expected results
2. 52If we are unable to meet the listing requirements of the NASDAQ Stock Market, our stock may be delisted
3. 53The price of our ADSs and common shares may be volatile
4. 54If we were to be characterized as a passive foreign investment company there could be adverse consequences to U.S. investors
5. 55We do not intend to pay cash dividends on the ordinary shares in the foreseeable future
6. 56The rights of our shareholders may differ from the rights typically offered to shareholders of a U.S. corporation
7. 57Under English law, it is only on a poll that the number of shares determines the number of votes a holder may cast. You should be aware, however, that the voting rights of ADSs are also governed by the provisions of a deposit agreement with our depositary bank
8. 58Shareholder protections found in provisions under the UK City Code on Takeovers and Mergers, or the Takeover Code, do not apply to us
9. 59the Takeover Code and, as a result, our shareholders are not currently entitled to the benefit of certain takeover offer protections provided under the Takeover Code, including the rules regarding mandatory takeover bids
10. 60The offeree company must appoint a competent independent adviser whose advice on the financial terms of the offer must be made known to all the shareholders, together with the opinion of the board of directors of the offeree company
11. 61All shareholders must be given the same information
12. 62Misleading, inaccurate or unsubstantiated statements made in documents or to the media must be publicly corrected immediately
13. 63U.S. shareholders may not be able to enforce civil liabilities against us
14. 64Potential technological changes in our field of business create considerable uncertainty
15. 65Negative economic conditions would likely have a negative effect on our ability to obtain financing on acceptable terms
16. 66Raising additional capital may cause dilution to our existing shareholders, restrict our operations or require us to relinquish rights
17. 67Potential business combinations or other strategic transactions may disrupt our business or divert management’s attention
18. 68an inability to successfully consummate any such transaction or collaboration
19. 69We may seek to enter into additional collaborations, licenses and other strategic transactions and may not be successful in doing so, and even if we are, we may relinquish valuable rights and may not realize the benefits of such relationships