Investor FAQs

You are about to review presentations, reports, filings and/or other materials regarding Amarin Corporation plc (NASDAQ: AMRN) that contain time-sensitive information. The information contained therein is only current as of the date thereof and may not be a complete listing of all documents filed with the Securities Exchange Commission, made public or provided to Amarin shareholders.

 

Amarin expressly disclaims any obligation to review, update or correct these materials after the date thereof. Amarin may update, amend, supplement or otherwise alter the information contained in any such materials by subsequent presentations, reports, filings, or other means without notice.

 

Certain statements made on this web site or in materials accessed in or through the investor relations section of our web site are "forward-looking statements," which are subject to risks and uncertainties, and Amarin's actual results may differ (possibly materially) from those indicated in such statements. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and its most recent Quarterly Report on Form 10-Q.

 

This website is not an offer or a solicitation to buy or sell securities. Please be aware that decisions regarding investments are the responsibility of users. Although this website includes information regarding pharmaceuticals (including products under development), the information is not intended as any advertisement and/or medical advice.

 

This information is intended for communication with investors and should not be construed as marketing the use of any Amarin products or product candidates.

 

Information on this website may be revised without any prior notice.

Investor FAQs

Please click here for a fact sheet on VASCEPA and a glossary of related terms.

REGULATORY APPROVAL STATUS OF VASCEPA®/VAZKEPA (ICOSAPENT ETHYL)

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Where can I find the approved label for VASCEPA® in the United States?
Where can I find the approved label for VAZKEPA in Europe?

Please click here.

What are Amarin’s plans and timing for VAZKEPA initial commercial launch in Europe?

Please click here.

Does European Commission approval of VAZKEPA grant regulatory exclusivity to Amarin for the label indication?

Please click here.

 Why has an outcomes study not been conducted with VASCEPA® of patients with TG levels ≥500 mg/dL to demonstrate that lowering TG levels in this population lowers the risk of pancreatitis?

Please click here

Where can I find the European Commission (EC) approval for VAZKEPA® (icosopent ethyl) to reduce the risk of cardiovascular events in patients at high cardiovascular risk?

Please click here.

Does the introduction of VASCEPA® (icosapent ethyl) into the Hainan Boao Lecheng International Medical Tourism Pilot Zone mean that the product has received regulatory approval in China?
Please click here.

VASCEPA®/VAZKEPA CLINICAL AND MECHANISTIC EFFECTS

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How does VASCEPA® work in lowering cardiovascular risk?

Please click here

What is the difference between using TG levels as an identifier of CV risk and correlating lowering TG levels with lowering CV risk?

Please click here

 Where can I find information on the results of the EVAPORATE trial presented at the European Society of Cardiology (ESC) Congress 2020- The Digital Experience on Saturday, August 29, 2020?
Please click here.
Where can I find the New England Journal of Medicine (NEJM) publication of the primary results of the REDUCE-IT® cardiovascular outcomes study?

The primary results of the REDUCE-IT cardiovascular outcomes study, which demonstrated that Vascepa® significantly lowers the rate of occurrence of major adverse cardiovascular events in at-risk patients, was published and can be found at: https://investor.amarincorp.com/publications under the Cardiovascular Outcomes Trials heading.

The results of the Total Events Analysis of the REDUCE-IT cardiovascular outcomes study published in the Journal of American College of Cardiology (JACC) is also available in the above section.

Other publications pertaining to Vascepa and the science supporting Vascepa are available at: https://investor.amarincorp.com/publications.

What were the eicosapentaenoic acid (EPA) levels reached in REDUCE-IT® and how did EPA levels impact the cardiovascular risk reduction seen?

Please click here.

Is there a location at which various slides presented at medical conferences regarding REDUCE-IT® clinical trial results can be found?

Yes, the American College of Cardiology has posted REDUCE-IT related slides as presented at various medical conferences. These presentations can be found by visiting https://www.acc.org/ and search for ‘REDUCE-IT’ in the search bar.

What is Amarin’s perspective on the use of mineral oil in its clinical trials and the variability commonly observed in blood-based lipid values in clinical trials of statin-stabilized patients?

Please click here.

REIMBURSEMENT AND THIRD-PARTY ENDORSEMENTS FOR VASCEPA®/VAZKEPA

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What medical societies have recognized icosapent ethyl (VASCEPA®) in their medical treatment guidelines or scientific statements?

Please click here.

What is Amarin’s position on The Institute for Clinical and Economic Review (ICER) final report on the cost effectiveness and value of VASCEPA®?

Please click here

What is the European market access (pricing and reimbursement) process and what key factors does Amarin believe will make it successful in achieving timely and adequate reimbursement in Europe?
Please click here.
What is Amarin’s view on the reliability of third-party script reporting services?

Please click here

PRODUCTS ATTEMPTING TO COMPETE WITH VASCEPA®/VAZKEPA

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What does Amarin think about the JAMA and Cochrane omega-3 meta-analyses?

Please click here.

What is Amarin’s opinion on the ASCEND and VITAL clinical trials in which Lovaza® failed to demonstrate cardiovascular benefit on top of statin therapy?

Please click here.

 Has there been scientific evidence pointing to differences between eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)?
Please click here.
Were the drug and patient population studied in the REDUCE-IT® trial the same as that in the STRENGTH trial?

Please click here.

What is Amarin’s perspective on the potential for competitors to use changes in biomarkers demonstrated in clinical trials of VASCEPA®, such as triglyceride level reduction, as a regulatory substitute for completing their own CVOT?

Please click here.

What is Amarin’s perspective on the focus of Matinas Biopharma on the importance of bioavailability and triglyceride lowering?

Please click here.

What is Amarin’s view on CFSAN's evaluation of proposed qualified health claims applicable to food and dietary supplement products containing the omega-3 acids?

Please click here.

What is Amarin doing to protect the VASCEPA® franchise against dietary supplement manufacturers that mislead the public by referencing REDUCE-IT® or VASCEPA?

Please click here.

Will increased demand for VASCEPA® negatively affect the global fish supply?

Please click here

Legal Matters

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Following VASCEPA’s® FDA approval in December 2019 (and launch in January 2020) for its new cardiovascular risk indication, what percentage of prescriptions for VASCEPA in the United States are for patients with triglyceride (TG) levels ≥ 500 mg/dL?

Please click here.

What is Amarin's plan for operations now that generic versions of icosapent ethyl have launched in the United States?

Please click here.

Do Amarin’s commercial plans in the U.S. change as a result of the launch of a second generic version of icosapent ethyl (IPE) from what was described in previous quarterly communications?

Please click here.

Where can I find a copy of the amended Amarin cardiovascular risk reduction patent litigation complaint filed on January 25, 2021 to include health care insurance provider, Health Net, LLC, in the litigation originally filed against Hikma on Nov. 30, 2020

Please click here.

Where can I find a copy of the Amarin patent litigation complaint filed against Hikma on November 30, 2020?

Please click here.

What is Amarin doing to ensure patients prescriptions are filled while generics have limited supply of product?

Please click here.

What is Amarin’s view on the GSK v. Teva litigation being reheard by the Federal Circuit panel that decided the case?

Please click here.

Where can I find information on the hearing audio, legal briefs and decision in connection with the MARINE patent ANDA litigation appeal at the U.S. Court of Appeals for the Federal Circuit?

Please click here.

What is the status of the Amarin petition for certiorari filed on February 11, 2021 with the U.S. Supreme Court in connection with the VASCEPA® MARINE ANDA patent litigation?

Please click here.

COVID-19 AND VASCEPA®/VAZKEPA

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For what stages of COVID-19 infection is Amarin researching the use of VASCEPA® (icosapent ethyl)?

Please click here.

What information is available to aid in understanding of the significance of clinical results from the VASCEPA COVID-19 CardioLink-9 Randomized Trial

What additional information is available to aid in understanding of the significance of clinical results from the VASCEPA COVID-19 CardioLink-9 Randomized Trial, which was presented as a Late Breaker Presentation at National Lipid Association (NLA) Scientific Sessions 2020 on December 12, 2020?

Please click here.

If a posting is made that an upcoming medical congress (e.g., meeting of a medical society for scientific review) will include a presentation regarding an ongoing clinical study or other data which has not yet been publicly presented, does this mean...
If a posting is made that an upcoming medical congress (e.g., meeting of a medical society for scientific review) will include a presentation regarding an ongoing clinical study or other data which has not yet been publicly presented, does this mean that the medical society and Amarin have seen the data in advance of the scheduled presentation and, if yes, why doesn’t Amarin present such data earlier?

Please click here.

 What is Amarin doing differently to promote VASCEPA® in light of the COVID-19 pandemic?

Please click here.

General Information

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 Is Amarin subject to the UK City Code on Takeovers and Mergers?

Amarin Corporation plc is not subject to the UK City Code on Takeovers and Mergers (the “Code”) because the central management and control of Amarin is situated outside the UK. Amarin is therefore not subject to Code requirements, including but not limited to, press release requirements if, under certain circumstances, the company is “the subject of rumour or speculation” or there is an “untoward movement” in the target share price.

Amarin is subject to the UK Companies Act 2016 as a company organized under the law of England and Wales. For more information, please review the public disclosures in our most recent 10-K, page 61-62: https://investor.amarincorp.com/static-files/bfd335ec-2d47-4aa7-8a59-b8a15e5cbaaf.

Despite being a company organized under such law, Amarin has an Irish, and not UK, tax residency for its parent company and for its wholly-owned subsidiary within which Vascepa revenues are recorded.

 On what stock exchanges are Amarin's ordinary shares traded?

Amarin's ordinary shares, represented by American Depositary Shares, are listed on the NASDAQ Capital Market under the ticker AMRN.

Until July 16th 2008, Amarin's ordinary shares were also listed on London's AIM (ticker: AMRN) and Dublin's IEX (ticker: H2E).

What is an ADS/ADR?

An American Depositary Share (ADS) is a security that represents an ownership interest in the shares of a foreign company trading on a U.S. securities market. The shares represented by the ADSs are held by a U.S. depositary bank and are evidenced by certificates called American Depositary Receipts (ADRs), although the terms ADS and ADR are often used interchangeably. ADRs enable U.S. investors to buy shares in foreign companies without undertaking cross-border transactions (i.e., in U.S. dollars), and they trade, clear and settle in accordance with U.S. market regulations and conventions.

 What types of companies issue ADRs?

Non-U.S. companies whose securities trade on a U.S. securities market.

 What is the ratio of Amarin ADRs to Amarin ordinary shares?

One Amarin ADR equals one Amarin ordinary share.

 Are holders of ADRs entitled to vote at Amarin's annual general meeting?

Holders of ADRs may authorize Citibank, Amarin's Depositary, to act as a proxy in exercising voting rights according to the number of ordinary shares represented by their respective ADRs.

When is Amarin's fiscal year?

Amarin's fiscal year is the 12-month calendar year ending December 31st.

 Where can I get information on the company?

lease visit our website at www.amarincorp.com where you can read more on our executive team, board of directors, company strategy, corporate governance, therapeutic focus, product pipeline and partnering activities.

 Where are Amarin's headquarters?

Amarin is headquartered in Dublin, Ireland.

Where can I find Amarin's financial statements?

Amarin's financial statements, including annual reports, can be found on Amarin's website www.amarincorp.com in the Investor Relations section here. Alternatively, you can find all of Amarin's filings with the U.S. Securities and Exchange Commission under the SEC Filings section of the website here.

 Who is Amarin's Registrar/Transfer Agent?

The U.S. Transfer Agent for Amarin's ADS holders is:

Citibank Shareholder Services
P.O. Box 43077
Providence, RI 02940-5000
USA
Tel: +1-877-248-4237d

The Registrar for Amarin's ordinary shares is:

Citi - Depositary Receipt Services
388 Greenwich Street
14th Floor
New York, NY 10013

AND

Equiniti
PO Box 4630,
Aspect House,
Spencer Road,
Lancing, West Sussex,
BN99 6QQ, England
Telephone: +44 121 415 7047d

Who is Amarin's Depositary?

The Depositary for Amarin's ADRs is:

Citibank Shareholder Services
P.O. Box 43077
Providence, RI 02940-5000
Tel: +1-877-248-4237d Fax: +1-201-324-3284d

citibank@shareholders-online.com

 Who is Amarin's independent registered public accounting firm?

Ernst & Young LLP
99 Wood Avenue South
Iselin, NJ 08830

How can I keep up to date with latest developments at Amarin?
You can register to receive updates announced by Amarin by submitting your email address on the Email Alerts section of our website, which option can be found on each page of the website www.amarincorp.com.
 Who can I contact regarding Amarin investor and shareholder related queries?

Please contact:
e-mail: investor.relations@amarincorp.com

 What is Amarin’s policy on market rumors, speculation and related stock price movements?

Amarin has a general policy to not comment on rumors or speculation, or stock price movement related to such rumors or speculation. A “no comment” comment from Amarin is neither confirmation nor denial of any given rumor or speculation; it simply relays that Amarin has no comment on the matter.