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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.
−Removed: 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.
+Added: Refer to Note 5 – Commitments and Contingencies in this Quarterly Report for any legal proceedings that became reportable during the three months ended September 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.
3 unchanged sentences
There have been no material changes to the risk factors presented under Item 1A.
−Removed: Risk Factors in our Annual Report other than as set forth below.
+Added: Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2024 other than as set forth below.
See Item 1A .
−Removed: Risk Factors in our Annual Report for a detailed discussion of risk factors affecting the Company.
+Added: Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2024 for a detailed discussion of risk factors affecting the Company.
Risks Related to the Commercialization and Development of VASCEPA
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If the collaboration is not successful, we may not be able to capitalize on the full market potential for VAZKEPA® in those countries .
−Removed: On June 20, 2025, we licensed the rights to VAZKEPA® in the EU Territory to Recordati .
−Removed: Our ability to receive payments from these arrangements will depend on Recordati’s ability to successfully commercialize VAZKEPA® in the EU Territory.
−Removed: The Recordati EU Licensing Agreement may pose many risks to us, including that:
−Removed: • 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;
−Removed: • 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®;
+Added: On June 20, 2025, we licensed the rights to VAZKEPA® in the Recordati Territory to Recordati .
+Added: Our ability to receive payments from these arrangements will depend on Recordati’s ability to successfully commercialize VAZKEPA® in the Recordati Territory.
+Added: The Recordati Licensing Agreement may pose many risks to us, including that:
+Added: • marketing authorizations for VAZKEPA in certain countries in the Recordati 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;
+Added: • Recordati has discretion in determining the efforts, resources and strategies they will apply to commercializing VAZKEPA® in the Recordati 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;
−Removed: • 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;
+Added: • 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 Recordati 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;
• Recordati could be involved in a business combination and the continued pursuit and emphasis on VAZKEPA® could be delayed, diminished or terminated.
−Removed: 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.
−Removed: 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.
−Removed: 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
−Removed: adversely affected, and we may not maintain profitability in the U.S.
+Added: If our ability to generate revenue under the Recordati 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 Licensing Agreement.
+Added: Our 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 footprint.
+Added: If we are not successful in our efforts to continue to market and sell VASCEPA in the U.S., including following our Global Restructuring Plan announced in June 2025, which reduced our headcount in Europe, primarily Europe's commercial operations, as a
+Added: result of our exclusive license agreement with Recordati, our anticipated revenues or our expenses could be materially adversely affected, and we may not maintain profitability in the U.S.
or obtain profitability internationally.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.