AMARIN CORP PLC\UK 10-Q

Item 1. Legal Proceedings In the ordinary course of business, we are from time to time involved in lawsuits, claims, investigations, proceedings, and threats of litigation relating to intellectual property, commercial arrangements and other matters. Refer to Note 5 – Commitments and Contingencies in this Quarterly Report for any legal proceedings that became reportable during the three and six months ended June 30, 2025, and updates to any descriptions of previously reported legal proceedings in which there have been material developments during such period. The discussion of legal proceedings included within Note 5 – Commitments and Contingencies is incorporated into this Item 1 by reference. Item 1A. Ri sk Factors This Quarterly Report on Form 10-Q contains forward-looking information based on our current expectations. Because our actual results may differ materially from any forward-looking statements that we make or that are made on our behalf, this section includes a discussion of important factors that could affect our actual future results, including, but not limited to, our ability to successfully commercialize VASCEPA and VAZKEPA, collectively referred to as VASCEPA, our capital resources, the progress and timing of our clinical programs, the safety and efficacy of our product candidates, risks associated with regulatory filings, the potential clinical benefits and market potential of our product candidates, commercial market estimates, future development efforts, patent protection, effects of healthcare reform, reliance on third parties effects of tax reform, and other risks set forth below. There have been no material changes to the risk factors presented under Item 1A. Risk Factors in our Annual Report other than as set forth below. See Item 1A . Risk Factors in our Annual Report for a detailed discussion of risk factors affecting the Company. Risks Related to the Commercialization and Development of VASCEPA We 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 countries . On June 20, 2025, we licensed the rights to VAZKEPA® in the EU Territory to Recordati . Our ability to receive payments from these arrangements will depend on Recordati’s ability to successfully commercialize VAZKEPA® in the EU Territory. The Recordati EU Licensing Agreement may pose many risks to us, including that: • marketing authorizations for VAZKEPA® in certain countries in the EU Territory have not yet been obtained and certain other authorizations will need to be transitioned to Recordati subject to approval by the relevant regulatory authorities; • Recordati has discretion in determining the efforts, resources and strategies they will apply to commercializing VAZKEPA® in the EU Territory and may not apply sufficient efforts or resources to or otherwise may pursue sub-optimal strategies for the commercialization of VAZKEPA®; • Recordati may mismanage its supply chain (including by ordering too many or too few units of VAZKEPA® from us) and also may not or may not be able to set favorable pricing for VAZKEPA® due to regulations, generic entry or other factors, all of which could negatively impact payments owed to us; • Recordati may be subject to changes in key personnel or strategic focus, have limited available funding or be subject to other external factors diverting resources or competing priorities, all of which could negatively impact the commercialization of VAZKEPA® in the EU Territory; • Recordati may use our intellectual property rights or our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property rights or otherwise expose us to potential litigation; and • Recordati could be involved in a business combination and the continued pursuit and emphasis on VAZKEPA® could be delayed, diminished or terminated. If our ability to generate revenue under the Recordati EU Licensing Agreement is adversely impacted by these or any other risks, our right to receive additional payments from the thereunder, including our share of the revenues generated by net sales of VAZKEPA® could be insufficient to achieve or maintain profitability or may result in VAZKEPA® being less valuable to us than if we had not entered into the Recordati EU Licensing Agreement. Our reduction in force related to our Recordati EU 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 footprint. If we are not successful in our efforts to continue to market and sell VASCEPA in the U.S., including following our organizational restructuring plan announced in June 2025, which reduced our headcount in Europe, primarily Europe's commercial operations, as a result of our exclusive license agreement with Recordati, our anticipated revenues or our expenses could be materially 39 adversely affected, and we may not maintain profitability in the U.S. or obtain profitability internationally. Further, we may need to cut back on research and development activities or we may need to implement other cost-containment measures, or we may need to raise additional funding that could result in substantial dilution or impose considerable restrictions on our business. Risks Related to Ownership of our ADSs and Ordinary Shares If we are unable to meet the listing requirements of the Nasdaq Stock Market, our ADS may be delisted. Our ADSs are listed and traded on Nasdaq, which has listing requirements that include a $1.00 minimum closing bid price requirement, or the Minimum Bid Requirement. Nasdaq will issue a deficiency notice if an issuer is in violation of a listing standard for a period of 30 business consecutive days. Such deficiency letter does not result in the immediate delisting of an issuer as there is a period of 180 calendar days from the deficiency notice to regain compliance with Nasdaq's minimum bid price requirement. If an issuer is unable to comply with Nasdaq's minimum bid price requirement after this 180-day calendar period, Nasdaq may elect, subject to any potential additional cure periods, to initiate a process that could delist the issuer from trading on the Nasdaq. We received a deficiency letter from Nasdaq in October 2023, as our ADSs had traded below $1.00 for 30 consecutive business days. In January 2024, we regained compliance with the Nasdaq listing requirements as our ADSs had traded above $1.00 for 10 consecutive business days. We received an additional deficiency letter in May 2024, as our ADSs had traded below $1.00 for 30 consecutive business days. On November 22, 2024, we received notice Nasdaq granted the Company an additional 180 calendar days, or until May 19, 2025, to regain compliance with the Minimum Bid Requirement. Effective as of April 11, 2025, we implemented an adjustment of the ratio of our ADSs to Ordinary Shares from one ADS representing one Ordinary Share to one ADS representing 20 Ordinary Shares, or the ADS Ratio Change. The ADS Ratio Change resulted in a 1-for-20 reverse split of issued and outstanding ADSs, and it had no effect on the Ordinary Shares. On April 29, 2025, we received written confirmation from Nasdaq that we regained compliance with the Nasdaq listing requirements as our ADSs had traded above $1.00 for 10 consecutive business days. While we have regained compliance with the Minimum Bid Requirement, there is no guarantee that we will be able to maintain such compliance, and we may receive additional deficiency letters in the future. Should such a delisting occur, it would adversely impact the liquidity and price of our ADSs and would impede our ability to raise capital. General Risk Factors Our business may be adversely affected by tariffs, trade sanctions or similar government actions. The recent imposition and ongoing discussions regarding certain trade restrictions, sanctions and tariffs on goods exported from the U.S. or imported into the U.S., as well as retaliatory measures enacted in response to such actions and related market volatility, could have a material adverse impact on our business, financial condition, results of operations and cash flows. In light of these events, there continues to exist significant uncertainty about the future relationship between the U.S. and other countries with respect to such trade policies. These developments, or the perception that any of them could occur, may have a material adverse effect on global economic conditions and the stability of global financial markets, and may significantly reduce global trade and, in particular, trade between the impacted nations and the U.S. Any of these factors could depress economic activity, lower product demand and restrict our access to potential partners, suppliers or other third parties we seek to do business with and, in turn, have a material adverse effect on the business and financial condition of such third parties, which in turn would negatively impact us.