Amarin (AMRN) risk factors, FY2025 10-K

Other

1. 01the loss of key personnel could have an adverse effect on our businessNew

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 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 affected90% rewritten
3. 04We are dependent on our collaboration partner for the commercialization of VAZKEPA in 59 countries focused in Europe. If the collaboration is not successful, we may not be able to capitalize on the full market potential for VAZKEPA in those countriesNew
4. 05Recordati could be involved in a business combination and the continued pursuit and emphasis on VAZKEPA could be delayed, diminished or terminatedNew
5. 06We have limited experience as a company in commercializing VASCEPA outside of the U.S. and may be unsuccessful in developing sales internationally46% rewritten
6. 07an inability by us or our partners to obtain regulatory and marketing approval or establish marketing channels in foreign jurisdictionsNew
7. 08Government and commercial payor actions outside of the U.S. have affected and will continue to affect access to and sales of our products
8. 09Factors 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 sustained commercial success in the U.S. and major markets outside of the U.S
9. 10Additional 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
10. 11study 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
11. 12Analysis 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 prospects85% rewritten
12. 13Heart Association Scientific Sessions in November 2022 and published online in the journal Circulation in June 2024 and were consistent with the evidence from the REDUCE-IT studyNew
13. 14Our reduction in force related to our Recordati Licensing Agreement with Recordati, and any similar efforts we may undertake in the future, may not be successful in mitigating risks and challenges associated with our business and establishing a more significant international footprint47% rewritten
14. 15The manufacture, supply and commercialization, including promotional activities, of VASCEPA is subject to regulatory scrutiny
15. 16Further, 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 VASCEPA70% rewritten
16. 17have a negative impact on us by making it easier for other products to achieve a CV risk reduction indication without the need in advance to conduct a long and expensive CV outcomes studyNew
17. 18We could face patent litigation related to the patents filed related to the REDUCE-IT study
18. 19We cannot predict the outcome of the pending lawsuits, any appeals, or any subsequently filed lawsuits or inter partes review
19. 20Our products and marketing efforts are subject to extensive post-approval government regulation27% rewritten
20. 21These 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
21. 22Changes 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
22. 23Ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations
23. 24the availability of capital
24. 25Failure 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 business21% rewritten
25. 26The use or anticipated use of artificial intelligence, or AI, technologies, including generative AI, by us or third parties, may increase or create new operational risksNew
26. 27We 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
27. 28political instability or other social or government protocols affecting our clinical trial sites
28. 29As 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 other parts of the world, we may encounter difficulties in managing the size and adaptability of our operations successfully92% rewritten
29. 30Our business is depending on successful life-cycle management efforts

Risks Related to Our Reliance on Third Parties

1. 31Our 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. 32If 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. 33Our 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. 34There are comparable foreign requirements under ICH guidelines30% rewritten
5. 35If Recordati, 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. 36We 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. 37We 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. 38Despite 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. 39If 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 accruals80% rewritten
2. 40Our 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
3. 41We 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
4. 42Securities 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
5. 43A change in our tax residence and/or tax laws could have a negative effect on our future profitability
6. 44We could be adversely affected by our exposure to customer concentration risk29% rewritten

Risks Related to Our Financial Position and Capital Requirements

1. 45We have a history of operating losses and anticipate that we will incur continued losses for an indefinite period of time28% rewritten
2. 46We may never generate sufficient revenue to achieve a steady state of profitability22% rewritten
3. 47Our 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. 48We 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. 49In order to fully realize the market potential of VASCEPA, we may need to enter into a new strategic collaboration or raise additional capital
6. 50the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights
7. 51Changes 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 Ordinary Shares

1. 52Our 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. 53If we are unable to meet the listing requirements of the Nasdaq Stock Market, our ADS may be delisted100% rewritten
3. 54The price of our ADSs may be volatile23% rewritten
4. 55If we were to be characterized as a passive foreign investment company there could be adverse consequences to U.S. investors
5. 56We do not intend to pay cash dividends on the ordinary shares in the foreseeable future
6. 57The rights of our shareholders may differ from the rights typically offered to shareholders of a U.S. corporation
7. 58Under 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. 59Shareholder protections found in provisions under the UK City Code on Takeovers and Mergers, or the Takeover Code, do not apply to us
9. 60the 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. 61The 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. 62All shareholders must be given the same information
12. 63Misleading, inaccurate or unsubstantiated statements made in documents or to the media must be publicly corrected immediately
13. 64U.S. shareholders may not be able to enforce civil liabilities against us56% rewritten
14. 65Holders of ADSs may not have the same voting rights as holders of ordinary shares and may not receive voting materials in time to be able to exercise their right to voteNew
15. 66Potential technological changes in our field of business create considerable uncertainty
16. 67Negative economic conditions would likely have a negative effect on our ability to obtain financing on acceptable terms
17. 68Raising additional capital may cause dilution to our existing shareholders, restrict our operations or require us to relinquish rights
18. 69Potential business combinations or other strategic transactions may disrupt our business or divert management’s attention
19. 70an inability to successfully consummate any such transaction or collaboration
20. 71We 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 relationships54% rewritten
21. 72transactions could delay the development and commercialization of our product candidates and reduce their competitiveness if they reach the market, which could have a material adverse effect on our business, financial condition and results of operationsNew
22. 73Our business may be adversely affected by tariffs, trade sanctions or similar government actionsNew