AMARIN CORP PLC\UK
For the period ended Jun 30, 2025. Filed Jul 30, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Jul 30, 2025
What changed in Risk Factors?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-07.
0000950170-25-064981
Item 1A. Risk FactorsUnregistered Sales of Equity Securities and Use of ProceedsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-07-30.
0000950170-25-099879
Item 1A. Risk FactorsUnregistered Sales of Equity Securities and Use of ProceedsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 14 previous paragraphs and 26 current paragraphs.
11 unchanged; 3 reworded; 12 added; 0 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 1 previous and 1 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
The current filing states there were no material changes to risk factors.
This is the filer’s own statement, not a conclusion from the comparison. Read its qualifications and the report it references.
Current filing’s statement
There have been no material changes to the risk factors presented under Item 1A. Risk Factorsin 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.
Added paragraphs (12)
Current report
Risks Related to the Commercialization and Development of VASCEPA
Current report
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.
Current report
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:
Current report
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;
Current report
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®;
Current report
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;
Current report
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;
Current report
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
Current report
Recordati could be involved in a business combination and the continued pursuit and emphasis on VAZKEPA® could be delayed, diminished or terminated.
Current report
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.
Current report
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.
Current report
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 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.
Reworded paragraphs (3)
Previous wording
Other than as set forth below, there have been no material changes to the risk factors presented under Item 1A. Risk Factorsin our 2024 Annual Report on Form 10-K filed with the SEC on March 12, 2025.
Current wording
There have been no material changes to the risk factors presented under Item 1A. Risk Factorsin 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.
Previous wording
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 (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 price requirement, there is no guarantee that we will be able to maintain such compliance, and we may receive additional deficiency letters in the future.
Current wording
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.
Previous wording
ADSs purchased in the first quarter of 2025 are as follows:
Current wording
ADSs purchased in the second quarter of 2025 are as follows: