What changed in this filing

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Item 9A. Controls and Procedures

2023-03-01 compared with 2022-03-01 · 355 added, 372 removed, 1102 unchanged (40% of the section changed)

3 unchanged sentences

As of December 31, 2022, our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act).

Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide

only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Our principal executive officer and principal financial officer have concluded based upon the evaluation described above that, as of December 31, 2022, our disclosure controls and procedures were effective at the reasonable assurance level.

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We have been from time to time advised that a number of our directors and employees, including members of our senior management team, and investment funds associated with such persons, have entered into trading plans in accordance with Rule 10b5-1 and our policy governing transactions in our securities.

It is not our policy to publicly disclose the terms of these private trading plans.

We undertake no obligation to update or revise the information provided herein, including for revision or termination of an established trading plan.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

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Security Ownership of Certain Beneficial Ow ners and Management and Related Stockholder Matters

The information required by this item will be contained in our definitive proxy statement, which will be filed with the SEC in connection with our 2022 Annual General Meeting of Shareholders.

The information required by this item will be contained in our definitive proxy statement, which will be filed with the SEC in connection with our 2023 Annual General Meeting of Shareholders to be filed within 120 days after the fiscal year ended December 31, 2022 ("Definitive Proxy Statement").

Such information is incorporated herein by reference.

74 unchanged sentences

July 14, 2020

Amendment No.

1 to 2020 Stock Incentive Plan*

Current Report on Form 8-K dated June 27, 2022, as Exhibit 10.2

June 30, 2022

Form of Incentive Stock Option Award Agreement*

5 unchanged sentences

Form of Restricted Stock Unit Award Agreement*

Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020, as Exhibit 10.4

November 5, 2020

Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2022, as Exhibit 10.3

August 3, 2022

Form of Non-Qualified Stock Option for Non-Employee Director Award Agreement*

1 unchanged sentence

November 5, 2020

Form of Deferred Restricted Stock Unit for Non-Employee Director Award Agreement*

Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020, as Exhibit 10.6

November 5, 2020

Form of Deferred Restricted Stock Unit Award Agreement*

Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2022, as Exhibit 10.2

August 3, 2022

Amarin Corporation plc Executive Severance and Change of Control Plan*

21 unchanged sentences

Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2019, as Exhibit 10.1

Letter Agreement with John Thero, dated January 10, 2014*

Current Report on Form 8-K dated January 8, 2014, as Exhibit 10.1

January 10, 2014

Amendment, dated July 6, 2015, to Letter Agreement with John Thero, dated January 10, 2014*

Offer Letter with Thomas Reilly, dated May 26, 2022*

Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2022, as Exhibit 10.4

August 3, 2022

Transitional Services and Separation Agreement between John Thero and Amarin Corporation plc, dated April 12, 2021*

Current Report on Form 8-K dated April 12, 2021, File No.

0-21392, as Exhibit 10.1

April 12, 2021

Letter Agreement with Joseph Kennedy, dated December 13, 2011*

Current Report on Form 8-K dated December 23, 2011, as Exhibit 10.5

December 23, 2011

Amendment, dated July 6, 2015, to Letter Agreement with Joseph Kennedy, dated December 13, 2011*

Transition and Separation Agreement between Michael W.

Kalb and Amarin Corporation plc, dated June 6, 2022*

Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2022, as Exhibit 10.3

August 3, 2022

2011 Long Term Incentive Award with Joseph Kennedy dated December 16, 2011*

Registration Statement on Form S-8, as Exhibit 4.1

March 16, 2012

Transitional Services and Separation Agreement between Joseph Kennedy and Amarin Corporation plc, dated April 28, 2021*

Current Report on Form 8-K dated April 28, 2021, as Exhibit 10.1

April 29, 2021

Transition Agreement between Jason M.

Marks and Amarin Corporation plc, dated December 6, 2022*

Filed herewith

API Commercial Supply Agreement, dated May 25, 2011, between Amarin Pharmaceuticals Ireland Ltd.

and Chemport Inc.

Filed herewith

Annual Report on Form 10-K for the year ended December 31, 2021, as Exhibit 10.35

March 1, 2022

Amendment to API Commercial Supply Agreement by and between Amarin Pharmaceuticals Ireland Ltd and Chemport Inc., dated April 4, 2012 **

Filed herewith

Annual Report on Form 10-K for the year ended December 31, 2021, as Exhibit 10.36

March 1, 2022

Second Amendment to API Commercial Supply Agreement by and between Amarin Pharmaceuticals Ireland Ltd.

and Chemport Inc., dated July 19, 2012 **

Filed herewith

Annual Report on Form 10-K for the year ended December 31, 2021, as Exhibit 10.37

March 1, 2022

Purchase and Sale Agreement, dated December 6, 2012, by and between Amarin Corporation plc, Amarin Pharmaceuticals Ireland Limited and BioPharma Secured Debt Fund II Holdings Cayman LP **

Filed herewith

Annual Report on Form 10-K for the year ended December 31, 2021, as Exhibit 10.38

March 1, 2022

Consent and Waiver, dated December 20, 2017, by and among Amarin Pharmaceuticals Ireland Limited, Amarin Corporation PLC, BioPharma Secured Debt Fund II Holdings Cayman LP and Pharmakon Advisors LP

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February 27, 2019

Online Office Agreement, dated as of April 12, 2019, by and between Amarin Pharmaceuticals Ireland Limited and Regus CME Ireland Limited

Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2019, as Exhibit 10.2

July 31, 2019

Office Service Agreement, dated as of April 12, 2019, by and between Amarin Pharmaceuticals Ireland Limited and Regus CME Ireland Ltd.

Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2019, as Exhibit 10.3

July 31, 2019

Online Office Agreement, dated as of July 3, 2019, by and between Amarin Pharmaceuticals Ireland Limited and Regus CME Ireland Ltd.

Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2019, as Exhibit 10.4

July 31, 2019

Online Office Renewal Agreement dated as of June 26, 2020, by and between Amarin Pharamecueticals Ireland Limited and Regus CME Irelnad Limited

Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020, as Exhibit 10.7

November 5, 2020

Online Office Renewal Agreement dated as of August 30, 2020, by and between Amarin Pharmaceuticals Ireland Limited and Regus CME Ireland Limited

Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020, as Exhibit 10.8

November 5, 2020

Online Office Renewal Agreement dated as of February 1, 2020, by and between Amarin Pharmaceuticals Ireland Limited and Regus CME Ireland Limited

Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2020, as Exhibit 10.1

April 30, 2020

Online Office Agreement dated as of March 30, 2021, by and between Amarin Germany GmbH and Regus

Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2021, as Exhibit 10.1

April 29, 2021

Online Office Agreement dated as of March 30, 2021, by and between Amarin Germany GmbH and Regus

Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2021, as Exhibit 10.2

April 29, 2021

English Summary of German Language Commercial Lease Agreement dated October 10, 2021, by and between Amarin Switzerland GmbH and Zug Estates AG

Annual Report on Form 10-K for the year ended December 31, 2021, as Exhibit 10.54

March 1, 2022

Consent of Landlord to Sublease dated as of January 20, 2023, among Amarin Pharma, Inc.

ST Shared Services LLC and Liberty Denver Wood LLC

Filed herewith

Online Office Agreement dated October 21, 2021, by and between Amarin Switzerland GmbH and Regus

Guaranty dated January 20, 2023, issued by MEH, Inc.

Filed herewith

Online Office Agreement dated October 21, 2021, by and between Amarin Switzerland GmbH and Regus

Sublease Agreement dated January 20, 2023, by and between Amarin Pharma, Inc.

and ST Shared Services LLC

Filed herewith

License Agreement dated September 13, 2022, between Amarin Pharmaceuticals Ireland Ltd and Weston Office Solutions Ltd

Filed herewith

List of Subsidiaries

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March 1, 2023

We, the undersigned officers and directors of the Registrant hereby severally constitute and appoint Karim Mikhail, Michael W.

Kalb and Jason Marks, and each of them singly, our true and lawful attorneys, with full power to them and each of them singly, to sign for us in our names in the capacities indicated below, all amendments to this report, and generally to do all things in our names and on our behalf in such capacities to enable the Registrant to comply with the provisions of the Securities Exchange Act of 1934, as amended, and all requirements of the Securities and Exchange Commission.

We, the undersigned officers and directors of the Registrant hereby severally constitute and appoint Karim Mikhail and Tom Reilly, and each of them singly, our true and lawful attorneys, with full power to them and each of them singly, to sign for us in our names in the capacities indicated below, all amendments to this report, and generally to do all things in our names and on our behalf in such capacities to enable the Registrant to comply with the provisions of the Securities Exchange Act of 1934, as amended, and all requirements of the Securities and Exchange Commission.

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the date indicated.

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March 1, 2023

/s/ Michael W.

/s/ Tom Reilly

Senior Vice President and Chief

Financial Officer (Principal

Financial Officer and Principal

Accounting Officer)

Financial and Accounting Officer)

March 1, 2023

/s/ Lars Ekman, M.D., Ph.D.

Lars Ekman, M.D., Ph.D.

/s/ Adam Berger

March 1, 2023

/s/ Patrick O’Sullivan

Patrick O’Sullivan

/s/ Erin Enright

March 1, 2023

/s/ Kristine Peterson

Kristine Peterson

/s/ Jan van Heek

March 1, 2023

/s/ David Stack

/s/ Geraldine Murphy

Geraldine Murphy

March 1, 2023

/s/ Jan van Heek

/s/ Kristine Peterson

March 1, 2023

/s/ Per Wold-Olsen

Kristine Peterson

/s/ Murray Stewart D.M., F.R.C.P.

Murray Stewart D.M., F.R.C.P.

March 1, 2023

Per Wold-Olsen

/s/ Joseph Zakrzewski

Joseph Zakrzewski

/s/ Alfonso Zulueta

Alfonso Zulueta

March 1, 2023

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(1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments.

The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not,

by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the account or disclosure to which it relates.

The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the account or disclosure to which it relates.

Product Return Reserve Estimate

66 unchanged sentences

Cost of goods sold

Cost of goods sold - restructuring inventory

Operating expenses:

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Total operating expenses

Operating income (loss)

Operating (loss) income

Interest income

1 unchanged sentence

Other (expense) income, net

Income (Loss) from operations before taxes

(Loss) income from operations before taxes

Provision for income taxes

Net income (loss)

Earnings (loss) per share:

Net (loss) income

(Loss) earnings per share:

Weighted average shares outstanding:

4 unchanged sentences

December 31, 2019

Issuance of common stock, net of

transaction costs

Issuance of common stock under

employee stock purchase plan

Issuance of common stock for

milestone payment

Exercise of stock options

Vesting of restricted stock units

Stock-based compensation

Loss for the period

December 31, 2019

Conversion of Series A

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December 31, 2021

Issuance of common stock under employee stock purchase plan

Issuance of common stock for milestone payment

Exercise of stock options

Vesting of restricted stock units

Stock-based compensation

Loss for the period

December 31, 2022

See the notes to the consolidated financial statements.

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CASH FLOWS FROM OPERATING ACTIVITIES:

Net income (loss)

Adjustments to reconcile net income (loss) to net cash used in operating activities:

Net (loss) income

Adjustments to reconcile net (loss) income to net cash used in operating activities:

Depreciation and amortization

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Purchases of securities

Investment in website development costs

Disposal (purchases) of furniture, fixtures and equipment

1 unchanged sentence

CASH FLOWS FROM FINANCING ACTIVITIES:

Proceeds from issuance of common stock, net of transaction costs

Proceeds from issuance of common stock under employee stock purchase plan

3 unchanged sentences

Taxes related to stock-based awards

Net cash (used in) provided by financing activities

NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH

Net cash used in financing activities

NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH

CASH AND CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD

1 unchanged sentence

Supplemental disclosure of cash flow information:

Cash received (paid) during the year for:

Cash (paid) received during the year for:

Supplemental disclosure of non-cash transactions:

Laxdale milestone

Shares issued in settlement of Laxdale milestone payment

Initial recognition of operating lease right-of-use asset

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Most of the Company’s historical revenue and sales, marketing and administrative activities and costs have been associated with commercial operations in the United States, or U.S.

In 2021 the Company began to increase pre-launch commercial activities throughout Europe.

As of September 1, 2021, product was made available in Germany and as of October 1, 2021 was included in the country's electronic prescribing system.

The Company has launched commercial operations in certain European countries, such as the United Kingdom, or the UK, and continues pre-launch commercial activities throughout the rest of Europe.

The Company’s operations outside of the U.S.

and Europe are in early stages of development with reliance on third-party commercial partners in select geographies, including China where regulatory approval for the Company’s lead product is being actively sought.

The Company’s lead product, VASCEPA ® (icosapent ethyl), was first approved by the U.S.

and Europe are in early stages of development with reliance on third-party commercial partners in select geographies.

The Company’s commercialized product, VASCEPA ® (icosapent ethyl), was approved by the U.S.

Food and Drug Administration, or U.S.

FDA, in July 2012 for use as an adjunct to diet to reduce triglyceride, or TG, levels in adult patients with severe ( > 500 mg/dL) hypertriglyceridemia.

In January 2013, the Company launched 1-gram size VASCEPA in the U.S.

and in October 2016, introduced a smaller 0.5-gram capsule size.

On December 13, 2019, the U.S.

FDA approved another indication and label expansion for VASCEPA based on the results of the Company’s long-term cardiovascular outcomes trial, REDUCE-IT ® , or Reduction of Cardiovascular Events with EPA –

Intervention Trial.

VASCEPA is approved by the U.S.

FDA as an adjunct to maximally tolerated statin therapy for reducing persistent cardiovascular risk in select high risk patients.

On March 30, 2020, following conclusion of a trial in late January 2020, the U.S.

District Court for the District of Nevada, or the Nevada Court, issued a ruling in favor of two generic drug companies, Dr.

FDA, in July 2012 for use as an adjunct to diet to reduce triglyceride, or TG, levels in adult patients with severe ( > 500 mg/dL) hypertriglyceridemia, or the MARINE indication.

VASCEPA was also approved for another indication in December 2019 for use as an adjunct to maximally tolerated statin therapy for reducing persistent cardiovascular risk in select high risk patients, or the REDUCE-IT indication.

In 2020, following our unsuccessful appeals of a court ruling in favor of two generic drug companies, Dr.

Reddy's Laboratories, Inc., or Dr.

Reddy's, and Hikma Pharmaceuticals USA Inc., or Hikma, and certain of their affiliates, or collectively, the Defendants, that declared as invalid several of the Company's patents covering the first U.S.

FDA-approved use of its drug, for use to reduce severely high triglyceride levels, which is known as the MARINE indication.

The Company sought appeals of the Nevada Court judgment up to the United States Supreme Court, but the Company was unsuccessful.

Most recently, on June 18, 2021, the Company was notified that its petition for writ of certiorari to the United States Supreme Court was denied.

On May 22, 2020, Hikma received U.S.

FDA approval to market its generic version of VASCEPA for the MARINE indication of VASCEPA.

In November 2020, Hikma launched their generic version of VASCEPA on a limited scale.

On November 30, 2020 the Company filed a patent infringement lawsuit against Hikma for making, selling, offering to sell and importing generic icosapent ethyl capsules in and into the United States in a manner that the Company alleges has induced the infringement of patents covering the use of VASCEPA to reduce specified cardiovascular risk.

On January 4, 2022, the district court hearing the case granted Hikma's motion to dismiss.

Amarin intends to appeal the decision of the district court.

Amarin also intends to continue to vigorously pursue the ongoing litigation with Health Net, LLC, but cannot predict the outcome or impact on its business.

On August 10, 2020, Dr.

Reddy’s received U.S.

FDA approval to market its generic version for the MARINE indication of VASCEPA.

In June 2021, Dr.

Reddy's launched its generic version of VASCEPA with labeling that is substantially similar to labeling of the Hikma generic product.

On September 11, 2020, Teva Pharmaceuticals USA, Inc.'s, or Teva's, abbreviated new drug application, or ANDA, was approved by the U.S.

FDA and on June 30, 2021, Apotex, Inc.'s, or Apotex's, ANDA was approved by the U.S.

In January 2022, Apotex launched its generic version of VASCEPA with labeling that is substantially consistent with the labeling of the Hikma and Dr.

Reddy's generic product, not the cardiovascular risk reduction indication.

Reddy's, and Hikma Pharmaceuticals USA Inc., or Hikma, and certain of their affiliates, or collectively, the Defendants, several of the Company's patents covering the MARINE indication were declared as invalid.

As a result, the following generic versions of VASCEPA have obtained U.S.

FDA approval with labeling consistent with the MARINE indication of VASCEPA and have entered the U.S.

market with a 1-gram capsule:

FDA MARINE Indication Approval

Hikma Pharmaceuticals USA Inc.

November 2020

Reddy’s Laboratories, Inc.

Teva Pharmaceuticals USA, Inc.

September 2020

September 2022 (1)

(1) - Teva launched a 0.5-gram capsule in September 2022 and a 1-gram capsule in January 2023.

On March 26, 2021, the European Commission, or EC, approved the marketing authorization application for VAZKEPA, hereinafter along with the U.S.

brand name VASCEPA, collectively referred to as VASCEPA, in the EU to reduce the risk of cardiovascular events in high-risk, statin-treated adult patients who have elevated triglycerides ( > 150 mg/dL) and either established cardiovascular disease or diabetes and at least one additional cardiovascular risk event.

On September 13, 2021, the Company launched VAZKEPA in Germany, representing the Company's first European launch.

brand name VASCEPA, collectively referred to as VASCEPA, in the European Union, or EU, to reduce the risk of cardiovascular events in high-risk, statin-treated adult patients who have elevated triglycerides ( > 150 mg/dL) and either established cardiovascular disease or diabetes and at least one additional cardiovascular risk event.

On April 22, 2021, the Company announced that the Medicines and Healthcare Products Regulatory Agency, or MHRA, approved VAZKEPA in England, Scotland and Wales to reduce cardiovascular risk through MHRA’s new ‘reliance’

route following the end of the BREXIT transition period.

On December 7, 2022, the Company announced that Swissmedic approved VAZKEPA in Switzerland.

Collectively CHMP, EMA, EC and MHRA are referred to herein as the European Regulatory Authorities.

In November 2020, the Company announced topline results from the Phase 3 clinical trial of VASCEPA conducted by the Company’s partner in China.

On February 9, 2021, the Company announced that regulatory review processes for approval of VASCEPA in Mainland China and Hong Kong have commenced.

On February 9, 2021, the Company announced that regulatory review processes for approval of VASCEPA in Mainland China and Hong Kong had commenced.

The Chinese National Medical Products Administration, or NMPA, has accepted for review the new drug application for VASCEPA based on the results from the Phase 3 clinical trial and the results from the Company’s prior studies of VASCEPA.

The Hong Kong Department of Health is evaluating VASCEPA based on current approvals in the United States and Canada.

On February 23, 2022, the Hong Kong Department of Health concluded their evaluation and approved the use of VASCEPA under the REDUCE-IT indication.

The Company currently has strategic collaborations to develop and commercialize VASCEPA in select territories outside the United States.

Amarin is responsible for supplying VASCEPA to all markets in which the product is sold, including the United States and Germany, as well as, in Canada, Lebanon and the United Arab Emirates where the drug is promoted and sold via collaboration with third-party companies that compensate Amarin for such supply.

Amarin is responsible for supplying VASCEPA to all markets in which the product is sold, including the United States, and certain countries throughout Europe, as well as, in Canada, Lebanon and the United Arab Emirates where the drug is promoted and sold via collaboration with third-party companies that compensate Amarin for such supply.

Amarin is not responsible for providing any generic company with drug product.

21 unchanged sentences

Accounting estimates are based on historical experience and other factors that are considered reasonable under the circumstances.

Estimates are used in determining such items as provisions for sales returns, rebates and incentives, chargebacks, and other sales allowances;

Estimates and assumptions relied upon in preparing these consolidated financial statements relate to, but are not limited to, such items as provisions for sales returns, rebates and incentives, chargebacks, and other sales allowances;

depreciable/amortizable lives;

21 unchanged sentences

The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer.

At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct.

The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services committed within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct.

The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the

performance obligation is satisfied.

For a complete discussion of accounting for net product revenue and licensing revenue, see Note 13—Revenue Recognition.

2 unchanged sentences

Cash and Cash Equivalents and Restricted Cash

Cash and cash equivalents consist of cash, deposits with banks and short-term highly liquid money market instruments with remaining maturities at the date of purchase of 90 days or less.

Cash and cash equivalents consist of cash, deposits with banks and short-term highly liquid money market instruments with original maturities at the date of purchase of 90 days or less.

Restricted cash represents cash and cash equivalents pledged to guarantee repayment of certain expenses which may be incurred for business travel under corporate credit cards held by employees.

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Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation.

We classify inventory as long-term inventory when consumption of the inventory is expected beyond our normal operating cycle.

The Company classifies inventory as long-term inventory when consumption of the finished goods and work in process inventory is expected beyond the normal operating cycle.

The Company classifies finished goods expected to be consumed within a normal operating cycle and all of VASCEPA's active pharmaceutical ingredient, or API, as current inventory.

An allowance is established when management determines that certain inventories may not be saleable.

2 unchanged sentences

The Company expenses inventory identified for use as marketing samples when they are packaged.

The average cost reflects the actual purchase price of VASCEPA active pharmaceutical ingredient, or API.

The average cost reflects the actual purchase price of VASCEPA API.

Long-Lived Asset Impairment

4 unchanged sentences

Intangible Asset, net

Intangible asset, net consists of milestone payments to the former shareholders of Laxdale Limited, or Laxdale, related to the 2004 acquisition of the rights to VASCEPA, which is the result of VASCEPA receiving marketing approval in the U.S.

for the first indication in 2012, the expanded label in 2019 and marketing authorization in Europe in 2021 and is amortized over its estimated useful life on a straight-line basis.

See Note 8—Commitments and Contingencies for further information regarding other obligations related to the acquisition of Laxdale Limited.

Intangible asset, net consists of website development costs and milestone payments to the former shareholders of Laxdale Limited, or Laxdale, related to the 2004 acquisition of the rights to VASCEPA, which is the result of VASCEPA receiving marketing approval in the U.S.

for the first indication in 2012, the expanded label in 2019 and marketing authorization in Europe in 2021.

These assets are amortized over its estimated useful life on a straight-line basis.

See Note 7—Commitments and Contingencies for further information regarding other obligations related to the acquisition of Laxdale.

Costs for Patent Litigation and Legal Proceedings

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The Company is currently under audit by the IRS for the Company’s 2018 U.S.

income tax return

and by the New Jersey Department of Treasury for the years 2012 to 2015 and the New York State Department of Taxation and Finance for the years 2017 and 2018 .

income tax return and by the New Jersey Department of Treasury for the years 2012 to 2015 .

Although the outcome of tax audits is always uncertain and could result in significant cash tax payments, the Company does not believe the outcome of these audits will have a material adverse effect on its consolidated financial position or results of operations.

Earnings (Loss) per Share

Basic net earnings (loss) per share is determined by dividing net income (loss) by the weighted average shares of common stock outstanding during the period.

Diluted net earnings (loss) per share is determined by dividing net income (loss) by diluted weighted average shares outstanding.

Diluted weighted average shares reflects the dilutive effect, if any, of potentially dilutive common shares, such as common stock options calculated using the treasury stock method and preferred stocks using the “if-converted”

In periods with reported net operating losses, all common stock options and preferred stock outstanding are deemed anti-dilutive such that basic and diluted net loss per share are equal.

The Company’s preferred stock, of which none is outstanding as of December 31, 2021 and December 31, 2020, was entitled to receive dividends on an as-if-converted basis in the same form as dividends actually paid on common shares.

Accordingly, the preferred stock was considered a participating security and the Company was required to apply the two-class method to consider the impact of the preferred stock on the calculation of basic and diluted earnings per share.

The Company is in a net loss position for the years ended December 31, 2020 and 2019 and is therefore not required to present the two-class method.

For the year ended December 31, 2021, while the Company is in a net income position, the two-class method does not need to be applied as only one class of stock was outstanding during the year.

The calculation of net income (loss) and the number of shares used to compute basic and diluted net earnings (loss) per share for the years ended December 31, 2021, 2020, and 2019 are as follows:

Net income (loss)—basic and diluted

(Loss) Earnings per Share

Basic net (loss) earnings per share is determined by dividing net (loss) income by the weighted average shares of common stock outstanding during the period.

Diluted net (loss) earnings per share is determined by dividing net (loss) income by diluted weighted average shares outstanding.

Diluted weighted average shares reflects the dilutive effect, if any, of potentially dilutive common shares, such as from the exercise of stock options and vesting of restricted stock units calculated using the treasury stock method.

In periods with reported net operating losses, all stock options and restricted stock units outstanding are deemed anti-dilutive such that basic and diluted net loss per share are equal.

The calculation of net (loss) income and the number of shares used to compute basic and diluted net (loss) earnings per share for the years ended December 31, 2022, 2021, and 2020 are as follows:

Net (loss) income —basic and diluted

Weighted average shares outstanding—basic

3 unchanged sentences

Weighted average shares outstanding—diluted

Net earnings (loss) per share—basic

Net earnings (loss) per share—diluted

For the years ended December 31, 2021, 2020 and 2019, the following potentially dilutive securities were not included in the computation of net earnings (loss) per share because the effect would be anti-dilutive or because performance criteria were not yet met for awards contingent upon such measures:

Net (loss) earnings per share—basic

Net (loss) earnings per share—diluted

For the years ended December 31, 2022, 2021 and 2020, the following potentially dilutive securities were not included in the computation of net (loss) earnings per share because the effect would be anti-dilutive or because performance criteria were not yet met for awards contingent upon such measures:

Stock options

1 unchanged sentence

Laxdale milestone shares

Preferred stock (if converted)

Stock options are anti-dilutive during periods of net earnings when the exercise price of the stock options exceeds the market price of the underlying shares on the last day of the reporting period.

1 unchanged sentence

Stock-Based Compensation

Stock-based compensation cost is generally measured at the grant date, based on the fair value of the award, and is recognized as compensation expense over the requisite service period.

For awards with performance conditions, if the achievement of the performance conditions is deemed probable, the Company recognizes compensation expense based on the fair value of the award over the estimated service period.

The Company reassesses the probability of achievement of the performance conditions for such awards each reporting period.

The Company accounts for stock-based compensation in accordance with the guidance of FASB ASC Topic 718, Compensation-Stock Compensation , or ASC 718, and requires the fair value of all stock-based payments to employees and non-employees to be recognized in the consolidated statement of operations over the requisite service period.

The fair value of the Company's restricted stock units is determined to be the market price on the date of the grant.

The Company estimates the fair value of stock option awards on the date of the grant using the Black-Scholes Model, which requires that the Company makes certain assumptions regarding:

(i) the expected volatility in the market price of its common stock;

(ii) dividend yield;

(iii) risk-free interest rates;

and (iv) the period of time employees are expected to hold the award prior to exercise, referred to as the expected holding period.

As a result, if the Company revises its assumptions and estimates, stock-based compensation expense could change materially for future grants.

For awards with performance conditions, if the achievement of the performance conditions is deemed probable, the Company recognizes compensation expense based on the grant date fair value of the award over the requisite service period.

The Company reassesses the probability of achievement of the performance conditions each reporting period.

The Company estimates the level of forfeitures expected to occur based on its historical data and records compensation cost only for those awards that are ultimately expected to vest.

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The Company does not require collateral or any other security to support credit sales.

Three customers individually accounted for 10% or more of the Company’s gross product sales.

Three customers individually accounted for 10% or more of the Company’s

gross product sales.

Customers A, B, and C accounted for 35 % , 31 % , and 27 % , respectively, of gross product sales for the year ended December 31, 2022 and represented 35 % , 21 % , and 39 % , respectively, of the gross accounts receivable balance as of December 31, 2022.

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The Company has not experienced any significant write-offs of its accounts receivable.

All customer accounts are actively managed and no losses in excess of amounts reserved are currently expected;

All customer accounts are actively managed and no losses are currently expected;

however, the Company is monitoring the potential negative impact of COVID-19 on the Company’s customers’

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Certain amounts payable pursuant to supply contracts are denominated in currencies other than the U.S.

The Company recorded a foreign currency loss within the Other (expense) income, net on the consolidated statement of operations of $ 0.6 million for the year ended December 31, 2021 and less than $ 0.1 million for each of the years ended December 31, 2020 and 2019 .

The Company recorded a foreign currency loss within the Other (expense) income, net on the consolidated statement of operations of $ 0.7 million, $ 0.6 million and less than $ 0.1 million for each of the years ended December 31, 2022, 2021, and 2020 , respectively.

Fair Value of Financial Instruments

The Company provides disclosure of financial assets and financial liabilities that are carried at fair value based on the price that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the

measurement date.

Fair value measurements may be classified based on the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities using the following three levels:

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Treasury Shares

Agency Securities

Corporate Bonds

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Commercial Paper

Agency Securities

Repo Securities

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The Company does not intend to sell these investment securities and the contractual maturities are not greater than 24 months .

Those with maturities greater than 90 days and less than 12 months are included in short-term investments on its consolidated balance sheet.

Those with original maturities greater than 90 days and less than 12 months are included in short-term investments on its consolidated balance sheet.

Those with remaining maturities in excess of 12 months are included in long-term investments on its consolidated balance sheet.

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The Company evaluates securities with unrealized losses to determine whether such losses are other than temporary.

The unrealized gain or loss for the year ended December 31, 2021 and December 31, 2020 was a loss of $ 0.2 million and a gain of $ 0.5 million, respectively.

The unrealized gain or loss for the year ended December 31, 2022 and December 31, 2021 were losses of $ 0.4 million and $ 0.2 million, respectively.

Interest on investments is reported in interest income.

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Restructuring

On September 22, 2021, the Company announced a Go-to-Market strategy for VASCEPA, or the Plan, which aims to expand healthcare professional engagement through a new omnichannel platform, enhance managed care access and optimize VASCEPA prescriptions for cardiovascular risk reduction.

As part of the process, the Company completed a reduction of its field force to approximately 300 sales representatives.

During the year ended December 31, 2021 the Company recognized approximately $ 13.7 million in charges related to the reduction in force, substantially all of which are cash expenditures for one-time termination benefits and associated costs, within Restructuring expense in the consolidated statements of operations.

The following table shows the change in restructuring liability, associated with the Plan, which is included within accrued expenses and other current liabilities:

On September 22, 2021, the Company announced a Go-to-Market strategy for VASCEPA.

As part of this strategy, the Company completed a reduction of its U.S.

field force to approximately 300 sales representatives, enhanced managed care access and optimized VASCEPA prescriptions for cardiovascular risk reduction.

During the year ended December 31, 2021, the Company recognized approximately $ 13.7 million in charges related to the reduction in force, substantially all of which were cash expenditures for one-time termination benefits and associated costs.

On June 6, 2022, the Company announced a Comprehensive Cost Reduction Plan which included an organizational restructuring plan to address shifts within the Company’s U.S.

As part of the plan, the Company completed a reduction of its U.S.

field force from approximately 300 sales representatives to approximately 75 sales representatives.

During the year ended December 31, 2022 the Company recognized approximately $ 9.4 million within Restructuring expense on the consolidated statement of operations related to the Comprehensive Cost Reduction Plan, substantially all of which are cash expenditures.

The Company also reviewed its contractual supplier purchase obligations and has taken steps to amend supplier agreements to align supply arrangements with current and future market demand resulting in charges of $ 18.1 million recognized within Cost of goods sold - restructuring inventory for the year ended December 31, 2022 on the consolidated statement of operations.

The Company continues to negotiate with other contract suppliers to align its supply arrangements with current and future global demand which may result in additional costs to the Company.

On August 19, 2022, the Company announced that after the conclusion of the fourth and final round of negotiations with the National Association of Statutory Health Insurance Funds, or GKV-SV, a viable agreement on the reimbursement price of VAZKEPA in Germany could not be reached.

As a result of the negotiation outcome with the GKV-SV, the Company discontinued its German business operations effective September 1, 2022.

The Company recognized approximately $ 4.2 million within Restructuring expense on the consolidated statement of operations, substantially all of which are cash expenditures.

The following table sets forth the components of the Company's restructuring charges for the years ended December 31, 2022 and 2021 (none in 2020):

For the Year Ended December 31,

Employee restructuring separation charges

Vendor contract charges

Total restructuring expense

Restructuring inventory

Stock forfeitures

Total restructuring costs incurred

The following table shows the change in restructuring liability which is included within accrued expenses and other current liabilities:

Restructuring Liability

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Balance at December 31, 2022

( 1) - Represents the acceleration of expense associated with the vesting of certain equity awards.

Recent Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, and are early adopted by the Company or adopted as of the specified effective date.

In December 2019, the FASB issued ASU No.

2019-12, Income Taxes (Topic 740), Simplifying the Accounting for Income Taxes , which simplifies the accounting for income taxes by eliminating certain exceptions to the guidance in ASC 740 related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period, the recognition of deferred tax liabilities for outside basis differences, among other simplifications.

The Company adopted this standard effective January 1, 2021 , which did no t have an impact on the Company's consolidated financial statements.

The Company believes that the impact of other recently issued but not yet adopted accounting pronouncements will not have a material impact on the Company’s consolidated financial position, results of operations, and cash flows, or do not apply to the Company’s operations.

The Company has evaluated all recently issued accounting pronouncements through the date of the financial statements and found that no recently issued accounting pronouncements, when adopted, will have a material impact on the Company’s condensed consolidated financial position, results of operations, and cash flows, or do not apply to the Company’s operations.

(3) Intangible Asset

Intangible asset consists of milestone payments to the former shareholders of Laxdale related to the 2004 acquisition of the rights to VASCEPA, which is the result of VASCEPA receiving marketing approval in the U.S.

Intangible asset consists of website development costs and milestone payments to the former shareholders of Laxdale related to the 2004 acquisition of the rights to VASCEPA, which is the result of VASCEPA receiving marketing approval in the U.S.

for the first indication in 2012, the expanded label in 2019 and marketing approval in Europe in 2021.

Upon approval of the marketing authorization application for VAZKEPA in March 2021, a milestone for £ 7.5 million was achieved, which resulted in the Intangible asset increasing by $ 12.0 million.

Refer to Note 8 –

Commitments and Contingencies for further details.

For the year ended December 31, 2022 , the Company capitalized $ 0.8 million of costs associated with the development of a global company website.

In accordance with ASC 350, the Company evaluates the remaining useful life of the intangible asset at each reporting period to determine if any events or circumstances warrant a revision to the remaining period of amortization.

As of December 31, 2021, the intangible asset has an estimated weighted-average remaining useful life of 9.3 years.

As of December 31, 2022, the intangible assets have an estimated weighted-average remaining useful life of 8.1 years.

The carrying value as of December 31, 2022 and 2021 is as follows:

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Finished goods

As of December 31, 2021 and 2020, we had $ 121.3 million and nil of Long-term inventory, respectively, as consumption is expected beyond our normal operating cycle.

The Company classifies inventory as long-term when consumption of the finished goods and work in process inventory are expected beyond the normal operating cycle.

As of December 31, 2022 and 2021, we had $ 163.6 million and $ 121.3 million of Long-term inventory, respectively.

(5) Property, Plant and Equipment

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The Company provides for depreciation and amortization using the straight-line method by charges to operations in amounts that depreciate the cost of the fixed asset over its estimated useful life.

Depreciation expense for the years ended December 31, 2021, 2020, and 2019 were $ 0.6 million, $ 0.6 million, and $ 0.2 million, respectively.

Depreciation expense for the years ended December 31, 2022, 2021, and 2020 were $ 0.6 million, annually.

Upon retirement or sale of assets, the cost of the assets disposed and the related accumulated depreciation are removed from the consolidated balance sheet and any resulting gain or loss is credited or expensed to operations.

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Accrued expenses and other current liabilities

Debt from Royalty-Bearing Instrument—December 2012 Financing

On December 6, 2012, the Company entered into a Purchase and Sale Agreement with BioPharma Secured Debt Fund II Holdings Cayman LP, or BioPharma.

Under this agreement, the Company granted to BioPharma a security interest in future receivables associated with the VASCEPA patent rights, in exchange for $ 100.0 million received at the closing of the agreement which occurred in December 2012.

In the agreement, the Company agreed to repay BioPharma up to $ 150.0 million with such repayment based on a portion of net revenues and receivables generated from VASCEPA.

On December 20, 2017, BioPharma assigned all rights under this agreement to CPPIB Credit Europe S.à

r.l., or CPPIB.

As of December 31, 2021 , the Company has no outstanding debt as the $ 150.0 million was previously repaid in full to CPPIB with the final payment being made in November 2020.

During the year ended December 31, 2020 , the Company recorded $ 1.6 million and $ 0.6 million of cash and non-cash interest expense, respectively, in connection with the royalty-bearing instrument ( none during 2021 ).

(7) Commitments and Contingencies

Litigation –

On March 30, 2020, the United States District Court for the District of Nevada, or the Nevada Court, ruled in favor of two generics companies, Hikma and Dr.

On March 30, 2020, the Nevada Court, ruled in favor of two generics companies, Hikma and Dr.

Reddy’s, in Amarin’s patent litigation related to its ANDAs that sought U.S.

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FDA approval to market their respective generic versions of icosapent ethyl.

In November 2020, Hikma priced and launched its generic version of icosapent ethyl.

In November 2020, Hikma announced the price and launched its generic version of icosapent ethyl.

In June 2021, Dr.

Reddy’s announced the price of its generic version of icosapent ethyl and launched its generic version of icosapent ethyl.

In January 2022, Apotex announced the price of its generic version of icosapent ethyl and launched its generic version of icosapent ethyl.

The generic versions of icosapent ethyl as approved by the U.S.

FDA for Hikma, Dr.

Reddy’s and Apotex pertains to the MARINE indication of VASCEPA, lowering of TG levels in patients with very high TG (>500 mg/dL).

As of December 31, 2021, Teva had not announced pricing or launched a generic version of icosapent ethyl.

Reddy’s announced the price and launched its generic version of icosapent ethyl.

In January 2022, Apotex announced the price and launched its generic version of icosapent ethyl.

In September 2022, Teva announced the price and launched its generic version of icosapent ethyl for the 0.5-gram capsule and the 1.0 gram capsule in January 2023.

All generic versions of icosapent ethyl as approved by the U.S.

FDA pertains to the MARINE indication of VASCEPA, lowering of TG levels in patients with very high TG (>500 mg/dL).

Current generic competition, together with past and on-going litigation related to such generic versions of icosapent ethyl are applicable to the U.S.

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The Company has invested over a decade of resources and expenses to develop with individual members of its third-party, active pharmaceutical ingredient supply chain the technical knowhow, manufacturing processes and related regulatory approvals that have helped enable the Company’s suppliers to supply the Company’s need for clinical and commercial supply globally.

Based on statements made by generic competitors, the active pharmaceutical ingredient of VASCEPA needed to manufacture their generic versions of VASCEPA is in limited supply to them.

The Company believes all icosapent ethyl generic manufacturers are similarly situated.

The Company believes the limited supply of generic icosapent ethyl may be due to such companies’

lack of adequate planning, investment, knowhow and expertise regarding this fragile active ingredient.

In November 2020, the Company filed a patent infringement lawsuit against Hikma in the United States District Court in Delaware.

The complaint alleges that Hikma induced the infringement of VASCEPA-related cardiovascular risk reduction U.S.

The complaint alleged that Hikma induced the infringement of VASCEPA-related CV risk reduction U.S.

9,700,537 (Composition for preventing the occurrence of cardiovascular event in multiple risk patient), 8,642,077 (Stable pharmaceutical composition and methods of using same), and 10,568,861 (Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease) by making, selling, offering to sell and importing generic icosapent ethyl capsules in or into the United States.

In January 2021, the Company expanded the scope of the VASCEPA CV risk reduction patent infringement lawsuit against Hikma to include a health care insurance provider in the United States, Health Net LLC, or Health Net.

Through insurance coverage and economic incentives the Company alleges that Health Net has actively induced pharmacies to dispense, and patients to use, Hikma

generic icosapent ethyl capsules in infringement of the related patents.

In the complaint, the Company is seeking remedies including a permanent injunction against the unlawful inducement by Hikma and Health Net of infringing uses of the Hikma generic product, i.e., uses to reduce cardiovascular risk as detailed in the patents, and monetary damages in an amount sufficient to compensate the Company for such infringement.

Through insurance coverage and economic incentives the Company alleged that Health Net has actively induced pharmacies to dispense, and patients to use, Hikma generic icosapent ethyl capsules in infringement of the related patents.

In the complaint, the Company sought remedies including a permanent injunction against the unlawful inducement by Hikma and Health Net of infringing uses of the Hikma generic product, i.e., uses to reduce cardiovascular risk as detailed in the patents, and monetary damages in an amount sufficient to compensate the Company for such infringement.

On January 4, 2022, the district court hearing the case granted Hikma's motion to dismiss.

The Company intends to appeal the decision of the district court and also intends to continue to vigorously pursue its ongoing litigation with Health Net, but cannot predict the outcome or the impact on its business.

On October 13, 2022, the district court granted final judgement on the aspect of the litigation relating to the Company and Hikma.

Company has appealed the decision of the district court.

On December 26, 2022, the Company entered into a settlement agreement with Health Net that resolved the litigation relating to the Company and Health Net.

The Company will continue to consider its legal options against parties similarly situated to Health Net and Hikma and acting in concert with either by making or selling any drug product or component thereof covered by the subject patents, or inducing others to do the same.

The Company intends to vigorously enforce its intellectual property rights relating to VASCEPA, but cannot predict the outcome of these lawsuits or any subsequently filed lawsuits

As has been a practice in the generic pharmaceutical industry, on April 27, 2021, Dr.

Reddy’s filed a complaint against the Company in the United States District Court for the District of New Jersey, Civil action No.21-cv-10309, alleging various antitrust violations stemming from alleged anticompetitive practices related to the supply of active pharmaceutical ingredient of VASCEPA.

The complaint also includes a related state law tortious interference claim.

As has been a practice in the generic pharmaceutical industry, on April 27, 2021 and February 21, 2023, Dr.

Reddy’s and Hikma, respectively, filed a complaint against the Company in the United States District Court for the District of New Jersey, Civil actions No.21-cv-10309 and No.3:23-cv-01016, alleging various antitrust violations stemming from alleged anticompetitive practices related to the supply of active pharmaceutical ingredient of VASCEPA.

The complaints also includes a related state law tortious interference claim.

Damages sought include recovery for alleged economic harm to Dr.

Reddy’s, payors and consumers, treble damages and other costs and fees.

Reddy’s and Hikma's, payors and consumers, treble damages and other costs and fees.

Injunctive relief against the alleged violative activities is also being sought by Dr.

Reddy’s.

Reddy’s and Hikma.

Amarin believes it has valid defenses and will vigorously defend against the claims.

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Amarin is cooperating with the government agencies and cannot predict when these investigations will be resolved, the outcome of the investigations or their potential impact on the Company’s business.

As has been a practice of class action legal counsel following governmental investigations and litigation by generics companies, Amarin is also named as a defendant in five antitrust class action lawsuits in the District Court for the District of New Jersey.

As has been a practice of class action legal counsel following governmental investigations and litigation by generics companies, Amarin is also named as a defendant in six antitrust class action lawsuits in the District Court for the District of New Jersey.

Amarin is a defendant in a class action lawsuit filed by Uniformed Fire Officers Association Family Protection Plan Local 854 and the Uniformed Fire Officers Association for Retired Fire Officers Family Protection Plan, on behalf of indirect purchasers, in the District Court for the District of New Jersey, Civil Action No.

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21-12416, alleging Amarin violated state and federal antitrust laws by monopolizing and engaging in a conspiracy to restrain trade in the icosapent ethyl drug and API markets.

Amarin is a defendant in a class action lawsuit filed by KPH Healthcare Services, Inc., on behalf of direct purchasers, in the District Court for the District of New Jersey, Civil Action No.

21-12747, alleging Amarin and its co-defendant suppliers violated state and federal antitrust laws by monopolizing and engaging in a conspiracy to restrain trade in the icosapent ethyl drug and API markets.

Amarin is a defendant in a class action lawsuit filed by Local 464A United Food and Commercial Workers Union Welfare Service Benefit Fund, on behalf of direct purchasers, in the District Court for the District of New Jersey, Civil Action No.

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21-13406, alleging Amarin violated state and federal antitrust laws by monopolizing and engaging in a conspiracy to restrain trade in the icosapent ethyl drug and API markets.

Amarin is a defendant in a class action lawsuit filed by Board of Trustees of Heavy and General Laborers' Local Unions 472 and 172 of N.J.

Welfare Fund, on behalf of indirect purchasers, in the District Court of New Jersey, Civil Action No.

21-14639, alleging Amarin violated state and federal antitrust laws by monopolizing and engaging in a conspiracy to restrain trade in the icosapent ethyl drug and API markets.

These cases have been consolidated into In re Vascepa Antitrust Litigation (Indirect Purchasers), Civil Action No.

21-12061, in the District Court for the District of New Jersey.

Amarin is a defendant in a class action lawsuit filed by KPH Healthcare Services, Inc., on behalf of direct purchasers, in the District Court for the District of New Jersey, Civil Action No.

21-12747, alleging Amarin violated state and federal antitrust laws by monopolizing and engaging in a conspiracy to restrain trade in the icosapent ethyl drug and API markets.

This case has been coordinated with the consolidated indirect purchaser case above as In re Vascepa Antitrust Litigation (Direct Purchasers), Civil Action No.

21-12747, in the District Court for the District of New Jersey.

Such antitrust litigation and investigations can be lengthy, costly and could materially affect and disrupt the Company’s business.

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Litigation –

On February 22, 2019, a purported investor in the Company’s publicly traded securities filed a putative class action lawsuit against Amarin Corporation plc, the chief executive officer and chief scientific officer in the U.S.

District Court for the District of New Jersey, Debendra Sharma v.

On February 22, 2019, a purported investor in the Company’s publicly traded securities filed a putative class action lawsuit against Amarin Corporation plc, the former chief executive officer and chief scientific officer in the U.S.

District Court for the District of New

Jersey, Debendra Sharma v.

Amarin Corporation plc, John F.

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On March 12, 2019, another purported investor filed a substantially similar lawsuit captioned Richard Borghesi v.

Amarin Corporation

Amarin Corporation plc, John F.

Thero and Steven Ketchum, No.

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PLC , case number 21-2071 (3d Cir.).

The Company intends to vigorously defend against any future complaint in this matter.

The Company is unable to reasonably estimate the loss exposure, if any, associated with these claims.

The Company has insurance coverage that is anticipated to cover any significant loss exposure that may arise from this action after payment by the Company of the associated deductible obligation.

On October 21, 2021, a purported investor in the Company's publicly traded securities filed a putative class action lawsuit against Amarin Corporation plc, the former chief executive officer and the chief financial officer in the U.S.

On June 14, 2022, the Court of Appeals for the Third Circuit affirmed the dismissal of the matter by the trial district court.

District Court for the District of New Jersey, Vincent Dang v.

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10, 2021), was filed in November 2021.

In December 2021, several Amarin shareholders moved to consolidate the cases and appoint a lead plaintiff and lead counsel pursuant to the Private Securities Litigation Reform Act.

In December 2021, several Amarin shareholders moved to consolidate the cases, or the Securities Litigation, and appoint a lead plaintiff and lead counsel pursuant to the Private Securities Litigation Reform Act.

The plaintiffs filed an amended complaint on January 13, 2023 that added as a defendant the Company's former general counsel.

The complaints in these actions are nearly identical and allege that the Company misled investors by allegedly downplaying the risk associated with the ANDA litigation described above and the risk that certain of the Company's patents would be invalidated.

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The Company is unable to reasonably estimate the loss exposure, if any, associated with these claims.

On April 7, 2022, a purported investor in the Company's publicly traded securities filed a derivative lawsuit naming the same officer defendants from the Securities Litigation, the Officer Defendants, and also the members of the Company's board of directors, and the Company as nominal defendant in the U.S.

District Court for the District of New Jersey, Gary Schader v.

Amarin Corporation plc, John F.

Thero, Michael W.

Kalb, Lars G.

Ekman, Jan Van Heek, Karim Mikhail, Patrick J.

O'Sullivan, Per Wold-Olsen, Kristine Peterson, David Stack, and Joseph S.

Zakrzewski, No.

3:22-cv-02017 (D.N.J.

The complaint alleges, like the Securities Litigation, that the defendants allegedly downplayed the risk associated with the ANDA litigation and the risk that certain of the Company's patents would be invalidated.

Based on the allegations, plaintiffs allege that the directors breached their fiduciary duties and that the Officer Defendants were unjustly enriched, and plaintiffs seek contribution from the Officer Defendants for any liability they incur in the Securities Litigation and for which they are indemnified by the Company.

On July 1, 2022, the plaintiff voluntarily dismissed this matter.

In addition to the above, in the ordinary course of business, the Company is from time to time involved in lawsuits, claims, investigations, proceedings, and threats of litigation relating to intellectual property, commercial arrangements and other matters.

Milestone and Supply Purchase Obligations

The Company entered into long-term supply agreements with multiple API suppliers and encapsulators.

The Company is relying on these suppliers to meet current and potential future global demand for its lead product.

The Company currently has long-term supply agreements with multiple API suppliers and encapsulators.

The Company is relying on these suppliers to meet current and potential future global demand for VASCEPA.

Certain supply agreements require annual minimum volume commitments by the Company and certain volume shortfalls may require payments for such shortfalls.

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The Company has incurred certain costs associated with the qualification of product produced by these suppliers.

Pursuant to the supply agreements, there is a total of approximately $ 196.1 million that is potentially payable over the term of such agreements based on minimum purchase obligations.

The Company continues to meet its contractual purchase obligations.

On June 6, 2022, the Company announced a Comprehensive Cost Reduction Plan which includes a comprehensive cost and organizational restructuring plan to address current shifts within the Company’s U.S.

business as a result of the generic competition.

As part of this plan, the Company has reviewed its contractual supplier purchase obligations and has entered into agreements with

some suppliers to amend supplier agreements to align supply arrangements with current and future market demand.

The Company continues to negotiate with other contract suppliers to align its supply arrangements with current and future global demand which may result in additional costs to the Company.

As of December 31, 2022 , the Company has a total of approximately $ 86.0 million in future contractual purchase obligations without consideration to ongoing discussions with other suppliers.

On March 26, 2021, the EC approved the marketing authorization application for VAZKEPA.

Under the 2004 share repurchase agreement with Laxdale upon receipt of pricing approval in Europe for the first indication for VASCEPA (or first indication of any product containing intellectual property acquired from Laxdale in 2004), the Company must make an aggregate stock or cash payment to the former shareholders of Laxdale (at the sole option of each of the sellers) of £ 7.5 million.

The Company recorded a liability of $ 12.0 million in Accrued expenses and other current liabilities on the consolidated balance sheet as of December 31, 2021.

Also under the Laxdale agreement, upon receipt of a marketing approval in Europe for a further indication of VASCEPA (or further indication of any other product acquired from Laxdale in 2004), the Company must make an aggregate stock or cash payment (at the sole option of each of the sellers) of £ 5.0 million (approximately $ 6.8 million as of December 31, 2021) for the potential market approval.

Under the 2004 share repurchase agreement with Laxdale upon receipt of pricing approval in Europe for the first indication for VASCEPA (or first indication of any product containing intellectual property acquired from Laxdale in 2004), the Company was obligated to make an aggregate stock or cash payment to the former shareholders of Laxdale (at the sole option of each of such former shareholders) of £ 7.5 million.

On July 13, 2022 in connection with the United Kingdom's National Institute for Health and Care Excellence, or NICE's, final guidance for reimbursement of VAZKEPA and use across the National Health Service, or NHS, in England and Wales, representing receipt of marketing approval in Europe for the first indication for VAZKEPA, the Company became obligated to make the aggregate milestone payment of £ 7.5 million to Laxdale’s former shareholders (in either stock or cash at the election of each shareholder).

A s of December 31, 2022, the Company has settled the first European indication approval milestone through issuance of stock and cash payments based on the respective shareholder's election.

Also under the Laxdale agreement, upon receipt of a marketing approval in Europe for a further indication of VASCEPA (or further indication of any other product acquired from Laxdale in 2004), the Company must make an aggregate stock or cash payment (at the sole option of each of such former shareholder) of £ 5.0 million (approximately $ 6.0 million as of December 31, 2022) for the potential market approval.

The Company has no provision for any of these obligations, except as noted above, since the amounts are either not paid or payable as of December 31, 2022 .

Marketing Obligations

As of December 31, 2021, the Company had certain marketing commitments, consisting of communication costs related to the direct-to-consumer activities, totaling approximately $ 0.3 million.

Preferred Stock

In March 2015, the Company entered into subscription agreements with both existing and new investors, or the Purchasers, for the private placement of a total of 391,017,970 restricted American Depositary Shares, or ADSs, each representing one share of Amarin’s Series A Convertible Preference Shares , par value £ 0.05 per share, in the capital of the Company, or Series A Preference Shares.

For each restricted ADS, the Purchasers paid a negotiated price of $ 0.15 (equating to $ 1.50 on an as-if-converted-to-ordinary-shares basis), resulting in gross proceeds to the Company of approximately $ 58.6 million before deducting estimated offering expenses of approximately $ 0.7 million.

At the request of the holders and provided certain conditions were met, each ten Series A Preference Shares were able to be consolidated and redesignated as one ordinary share, par value £ 0.50 per share, in the capital of the Company, each ordinary share to be represented by ADSs.

During the years ended December 31, 2020, 2018, and 2015, the Company issued 28,931,746 , 3,886,718 , and 6,283,333 ADSs, respectively, upon consolidation and redesignation of Series A Preference Shares at the request of the holders, such that no Series A Preference Shares remained outstanding as of December 31, 2021 and December 31, 2020.

Refer to the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 for a more complete background.

On July 13, 2022, in connection with the United Kingdom's National Institute for Health and Care Excellence, or NICE's, final guidance for reimbursement of VAZKEPA and use across the National Health Service, or NHS, in England and Wales, representing receipt of marketing approval in Europe for the first indication for VAZKEPA, the Company became obligated to make an aggregate milestone payment of £ 7.5 million to Laxdale's former shareholders (in either stock or cash at the election of each shareholder) under the 2004 purchase agreement among the Company and such former shareholders.

One of the shareholders elected to receive payment in stock for its pro rata portion of the milestone payment, resulting in the issuance of 5,817,942 shares at a price of $ 1.41 per share in July 2022.

During the years ended December 31, 2022 and 2021, other than as described elsewhere in this Annual Report on Form 10-K, including in the Notes to Consolidated Financial Statements, the Company did not engage in any transactions involving its common stock.

Refer to Preferred Stock above for discussion of the consolidation and redesignation of Series A Preference Shares which resulted in the issuance of ordinary shares.

Refer to Incentive Equity Awards below for discussion of ordinary shares issued as a result of stock option exercises and restricted stock unit vestings.

Refer to Incentive Equity Awards below for discussion of ordinary shares issued as a result of stock option exercises and the vesting of restricted stock units.

Refer to Note 9—Stock Incentive Plans and Stock Based Compensation for discussion of shares issued under the Company’s employee stock purchase plan.

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Upon termination of service to the Company or upon a change of control, each director shall be entitled to a payment equal to the fair market value of one share of Amarin common stock per award vested or granted, respectively, which is required to be made in shares.

(9) Stock Incentive Plans and Stock-Based Compensation

On March 16, 2020, the Company’s Board of Directors, upon the recommendation of the Remuneration Committee, adopted, subject to shareholder approval, the 2020 Plan which was subsequently approved by the Company’s shareholders on July 13, 2020 at the Annual General Meeting of Shareholders.

The 2020 Plan is the successor to the Company’s 2011 Plan, which was set to expire on July 12, 2021, and the Company’s 2002 Plan, the Plans.

The 2020 Plan allows the Company to grant stock options, both incentive and non-qualified options, to employees and Directors, restricted stock units to employees and unrestricted shares to Directors.

The maximum number of the Company’s Ordinary Shares of £ 0.50 each or any ADS’s, as to be issued under the 2020 Plan shall not exceed the sum of (i) 20,000,000 shares and (ii) the number of Shares that remained available for grants under the Company’s 2011 Plan as of July 13, 2020.

If any award granted and outstanding under the Plans expires or is forfeited, surrendered, canceled or otherwise terminated, the shares may be made available for subsequent grants under the 2020 Plan.

The 2020 Plan is administered by the Remuneration Committee of the Company’s Board of Directors and expires on July 13, 2030.

Stock Options

Under the terms of the Plans, stock options typically vest over a four-year period and expire after a ten-year term.

The stock options are granted at an exercise price equal to the closing price of the Company’s American Depositary Shares on the grant date.

The following table summarizes all stock option activity for the year ended December 31, 2022:

In thousands (except per share amounts and years)

Outstanding as of January 1, 2022

Outstanding as of December 31, 2022

Exercisable as of December 31, 2022

Vested and expected to vest as of December 31, 2022

Available for future grant as of December 31, 2022

The weighted average grant date fair value of stock options granted during the years ended December 31, 2022, 2021, and 2020 was $ 2.56 , $ 5.12 , and $ 14.43 , respectively.

The total grant date fair value of options vested during the years ended December 31, 2022, 2021, and 2020 was $ 16.6 million, $ 21.1 million, and $ 22.5 million, respectively.

During the years ended December 31, 2022, 2021 and 2020, the Company received proceeds from the exercise of options of $ 0.1 million, $ 2.9 million, and $ 5.2 million, respectively.

The total intrinsic value of options exercised during the years ended December 31, 2022, 2021, and 2020 was nominal, $ 4.9 million, and $ 9.0 million, respectively, calculated as the difference between the quoted stock price of the Company’s common stock as of the reporting date and the exercise prices of the underlying awards.

As of December 31, 2022, options have $ 13.5 million of unrecognized stock-based compensation expense with such expense expected to be recognized over a weighted-average period of approximately 2.1 years.

The fair value of stock options on the date of grant was estimated using the Black-Scholes option pricing model.

Use of a valuation model requires management to make certain assumptions with respect to selected model inputs, which include:

Risk free rate :

The risk-free interest rate is based on zero-coupon U.S.

Treasury securities with a maturity term approximating the expected life of the option at the date of grant.

Expected dividend yield :

No dividend yield has been assumed as the Company does not currently pay dividends on its common stock and does not anticipate doing so in the foreseeable future.

Expected option life:

The expected life was determined using the simplified method based on the term and vesting period.

Expected volatility:

Expected stock price volatility was calculated based on the historical volatility of the Company’s common stock over the expected life of the option.

For 2022, 2021, and 2020, the Company used the following assumptions to estimate the fair value of share-based payment awards:

Risk-free interest rate

1.64 % - 4.35 %

0.53 % - 1.36 %

0.33 % - 1.74 %

Expected dividend yield

Expected option life (years)

Expected volatility

Employee stock options generally require future service and vest ratably over a four-year service period and are settled by the issuance of new common shares.

The grant date fair value of the stock options, net of an estimated forfeiture rate is amortized straight-line over the awards’

vesting periods or respective requisite service periods and is adjusted for actual forfeitures over such period.

The Company recorded compensation expense in relation to stock options of $ 14.8 million, $ 23.0 million, and $ 22.4 million for the years ended December 31, 2022, 2021, and 2020, respectively.

Restricted Stock Units

The restricted stock units vest based upon either a time-based service condition, a performance condition, or both.

The grant date fair value of the restricted stock unites, net of the estimated forfeiture rate, is amortized straight-line over the vesting periods or requisite service periods and is adjusted for actual forfeitures over such period.

For any awards with a performance condition, the probability that any performance criteria will be achieved is assessed by management and compensation expense for such awards is only recorded to the extent that the attainment of the performance criteria is deemed to be probable.

The following table presents the restricted stock unit activity for the year ended December 31, 2022 :

In thousands (except per share amounts)

Weighted Average

Grant Date Fair

Outstanding as of January 1, 2022

Outstanding as of December 31, 2022

The Company recorded compensation expense in relation to restricted stock units of $ 11.4 million, $ 13.9 million, and $ 23.4 million for the years ended December 31, 2022, 2021, and 2020 respectively.

As of December 31, 2022, restricted stock units have $ 23.7 million of unrecognized stock-based compensation expense with such expense to be recognized over a weighted-average period of approximately 2.2 years.

The following table presents the stock-based compensation expense related to stock-based awards for the years ended December 31, 2022, 2021, and 2020:

Research and development

Selling, general and administrative

Restructuring

Stock-based compensation expense

Employee Stock Purchase Plan

On March 13, 2017, the Board adopted, subject to shareholder approval, the Amarin Corporation plc 2017 Employee Stock Purchase Plan, or the ESPP, which was approved by the Company’s shareholders on May 15, 2017.

The ESPP is intended to qualify as an “employee stock purchase plan”

within the meaning of Section 423 of the Internal Revenue Code.

The maximum fair market value of stock which can be purchased by a participant in a calendar year is $ 25,000 .

Under the ESPP, an aggregate of 3,000,000 ordinary shares (each ordinary share to be represented by one ADS) are reserved and available for issuance, which were registered with the SEC on August 2, 2017, for sale to eligible employees.

Subject to certain exclusions, any employee of the Company’s U.S.

subsidiary, Amarin Pharma, Inc., who works at least 20 hours per week and has been employed for at least six months as of the first day of the applicable offering period is eligible to participate in the ESPP.

Eligible employees may authorize payroll deductions of up to 15 percent of their base pay to be withheld to purchase ordinary shares, subject to terms and limitations of the plan, at a price equal to 85 percent of the lower of the fair market values of the Company’s ordinary shares as of the beginning or the end of six-month offering periods.

For the offering periods ended on the last business day on or before each of May 31, 2022 and November 30, 2022, the Company issued 265,214 shares and 191,482 shares, respectively, at a purchase price of $ 1.45 per share and $ 1.15 per share, respectively.

For the offering periods ended on the last business day on or before each of May 31, 2021 and November 30, 2021, the Company issued 226,402 shares and 172,884 shares, respectively, at a purchase price of $ 3.86 per share and $ 3.06 per share, respectively.

For the offering periods ended on the last business day on or before each of May 31, 2020 and November 30, 2020, the Company issued shares 123,608 shares and 223,545 shares, respectively, at a purchase price of $ 5.83 per share and $ 4.22 per share, respectively.

As of December 31, 2022, 1,361,577 shares were reserved for future issuance under the ESPP.

(10) Income Taxes

The Company recognizes interest and penalties related to uncertain tax positions within the provision for income taxes.

Interest and penalties related to any uncertain tax positions have historically been insignificant.

The total amount of unrecognized tax benefits that would affect the Company’s effective tax rate if recognized is $ 8.2 million and $ 7.9 million as of December 31, 2022 and 2021, respectively.

The Company recognized interest related to uncertain tax positions of $ 0.9 million and nil for the years ended December 31, 2021 and 2020 , respectively.

The Company recognized interest related to uncertain tax positions of $ 0.5 million and $ 0.9 million for the years ended December 31, 2022 and 2021 , respectively.

No penalties have been recognized in conjunction with these positions.

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Ireland and United Kingdom

Total Income / (Loss) Before Taxes

The provision for income taxes shown in the accompanying consolidated statements of operations consists of the following for fiscal 2021, 2020 and 2019:

Total (loss) / income before taxes

The provision for income taxes shown in the accompanying consolidated statements of operations consists of the following for the years ended December 31, 2022, 2021 and 2020:

United States—Federal

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United States—State

Ireland and United Kingdom

Change in valuation allowance

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Provision for income taxes

The provision for income taxes differs from the amount computed by applying the statutory income tax rate to income before taxes due to the following for fiscal 2021, 2020 and 2019:

The provision for income taxes differs from the amount computed by applying the statutory income tax rate to income before taxes due to the following for the years ended December 31, 2022, 2021 and 2020:

Benefits from taxes at statutory rate

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Net operating loss carryback

Cumulative translation adjustment

Foreign exchange

Permanent and other

Corscianto liquidation

Long-term debt from royalty-bearing instrument

Uncertain tax positions

Foreign-derived intangible income

Loss of tax attributes

Provision for income taxes

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However, for Amarin Pharmaceuticals Ireland Limited, a wholly-owned subsidiary of Amarin Corporation plc, the Company applied the 12.5 % Irish trading tax rate.

In the table above, the Company used Amarin Corporation plc’s 25% tax rate as the starting point for the reconciliation since it is the parent entity of the business.

In the table above, the Company used Amarin Corporat ion plc’s 25% tax rate as the starting point for the reconciliation since it is the parent entity of the business.

On August 16, 2022, the Inflation Reduction Act of 2022, or the Act, was signed into law by the Biden Administration, with tax provisions effective January 1, 2023 primarily focused on implementing a 15% minimum tax on global adjusted financial statement income (CAMT) and a 1% excise tax on share repurchases.

While we are still evaluating the impact of the Act, we do not expect either of these provisions to have a material impact on our financial results.

On March 27, 2020, the Coronavirus Aid, Relief and Economic Security Act, or CARES Act, was enacted in the United States.

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Improvements to Share-Based Payment Accounting which changes the accounting for certain aspects of share-based payments to employees.

One aspect of the standard requires that excess tax benefits and deficiencies that arise upon vesting or exercise of share-based payments be recognized

as an income tax benefit and expense in the income statement.

One aspect of the standard requires that excess tax benefits and deficiencies that arise upon vesting or exercise of share-based payments be recognized as an income tax benefit and expense in the income statement.

Previously, such amounts were recognized as an increase and decrease in additional paid-in capital.

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Stock-based compensation

Capitalized R&D

Lease liability

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The Company assesses whether it is more-likely-than-not that the Company will realize its deferred tax assets.

The Company determined that it was more-likely-than-not that the Irish, U.S., UK, and Israeli net operating losses and the related deferred tax assets would not be realized in future periods and a full valuation allowance has been provided for all periods.

The Company determined that it was more-likely-than-not that the Irish, U.S., Germany, and Israeli net operating losses and the related deferred tax assets would not be realized in future periods and a full valuation allowance has been provided for all periods.

The following table reflects the activity in the valuation allowance for the years ended December 31, 2022 and 2021:

1 unchanged sentence

Increase as reflected in income tax expense

Cumulative translation adjustment

Foreign exchange

Ending valuation allowance

1 unchanged sentence

These adjustments were fully offset with valuation allowances based on the Company’s position with respect to the realizability of its recorded deferred tax assets.

The Company has combined U.S., Irish, UK, and Israeli net operating loss carryforwards of $ 849.9 million, which do not expire.

The total net operating loss carryforwards decreased by approximately $ 50.6 million from the prior year primarily as a result of current year income generated by the Company’s U.S.

and Irish subsidiaries, the impact of foreign exchange rate changes, and adjustments to reconcile the financial statement accounts to the amounts reported on the filed 2020 foreign tax returns.

The Company has combined U.S.

net operating loss carryforwards of $ 834.4 million, which do not expire.

The total net operating loss carryforwards decreased by approximately $ 15.6 million from the prior year primarily as a result of current year loss generated by the Company’s U.S.

subsidiaries, the impact of foreign exchange rate changes, and adjustments to reconcile the financial statement accounts to the amounts reported on the filed 2021 foreign tax returns.

In addition, the Company has U.S.

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Although the outcome of tax audits is always uncertain and could result in significant cash tax payments, the Company does not believe the outcome of these audits will have a material adverse effect on the Company's consolidated financial position or results of operations.

(11) Stock Incentive Plans and Stock-Based Compensation

On March 16, 2020, the Company’s Board of Directors, upon the recommendation of the Remuneration Committee, adopted, subject to shareholder approval, the 2020 Stock Incentive Plan, or 2020 Plan, which was subsequently approved by the Company’s shareholders on July 13, 2020 at the Annual General Meeting of Shareholders.

The 2020 Plan is the successor to the Company’s 2011 Stock Option Plan, as amended, or the 2011 Plan, which was set to expire on July 12, 2021, and the Company’s 2002 Stock Option Plan, as amended, or the 2002 Plan, and together with the 2020 Plan and 2011 Plan, the Plans.

If any award over shares granted and outstanding under the Plans expires or is forfeited, surrendered, canceled or otherwise terminated, the shares may be made available for subsequent grants under the Plan.

The award of stock options (both incentive and non-qualified options) and restricted stock units, and awards of unrestricted shares to Directors are permitted.

The 2020 Plan is administered by the Remuneration Committee of the Company’s Board of Directors and expires on July 13, 2030.

Stock Options

Under the terms of the Plans, stock options typically vest over a four-year period, expire after a ten-year term and are granted at an exercise price equal to the closing price of the Company’s American Depositary Shares on the grant date.

The following table summarizes all stock option activity for the year ended December 31, 2021:

In thousands (except per share amounts and years)

Outstanding as of January 1, 2021

Outstanding as of December 31, 2021

Exercisable as of December 31, 2021

Vested and expected to vest as of December 31, 2021

Available for future grant as of December 31, 2021

The weighted average grant date fair value of stock options granted during the years ended December 31, 2021, 2020, and 2019 was $ 5.12 , $ 14.43 , and $ 17.07 , respectively.

The total grant date fair value of options vested during the years ended December 31, 2021, 2020, and 2019 was $ 21.1 million, $ 22.5 million, and $ 14.5 million, respectively.

During the years ended December 31, 2021, 2020 and 2019, the Company received proceeds from the exercise of options of $ 2.9 million, $ 5.2 million, and $ 24.5 million, respectively.

The total intrinsic value of options exercised during the years ended December 31, 2021, 2020, and 2019 was $ 4.9 million, $ 9.0 million, and $ 90.5 million, respectively, calculated as the difference between the quoted stock price of the Company’s common stock as of the reporting date and the exercise prices of the underlying awards.

As of December 31, 2021, there was $ 30.7 million of unrecognized stock-based compensation expense related to unvested stock option share-based compensation arrangements granted under the Company’s stock award plans.

This expense is expected to be recognized over a weighted-average period of approximately 2.2 years.

The Company recognizes compensation expense for the fair values of those awards which have graded vesting on a straight-line basis.

The fair value of stock options on the date of grant was estimated using the Black-Scholes option pricing model.

Use of a valuation model requires management to make certain assumptions with respect to selected model inputs.

Expected stock price volatility was calculated based on the historical volatility of the Company’s common stock over the expected life of the option.

The expected life was determined using the simplified method based on the term and vesting period.

The risk-free interest rate is based on zero-coupon U.S.

Treasury securities with a maturity term approximating the expected life of the option at the date of grant.

No dividend yield has been assumed as the Company does not currently pay dividends on its common stock and does not anticipate doing so in the foreseeable future.

Estimated forfeitures are based on the Company’s historical forfeiture activity.

Employee stock options generally vest over a four-year service period and all stock options are settled by the issuance of new shares.

Compensation expense recognized for all option grants is net of estimated forfeitures and is recognized over the awards’

respective requisite service periods.

The vesting of certain stock options is contingent upon the attainment of performance criteria.

The probability that such criteria will be achieved is assessed by management and compensation expense for such awards is only recorded

to the extent that the attainment of the performance criteria is deemed to be probable.

The Company recorded compensation expense in relation to stock options of $ 23.0 million, $ 22.4 million, and $ 16.3 million for the years ended December 31, 2021, 2020, and 2019, respectively.

For 2021, 2020, and 2019, the Company used the following assumptions to estimate the fair value of share-based payment awards:

Risk-free interest rate

0.53 % - 1.36 %

0.33 % - 1.74 %

1.55 % - 2.95 %

Expected dividend yield

Expected option life (years)

Expected volatility

Restricted Stock Units

The Plans also allow for granting of restricted stock unit awards under the terms of the Plans.

The restricted stock units vest based upon a time-based service condition, a performance condition, or both.

The probability that any performance criteria will be achieved is assessed by management and compensation expense for such awards is only recorded to the extent that the attainment of the performance criteria is deemed to be probable.

Restricted stock units are recorded as compensation expense based on fair value, representing the market value of the Company’s common stock on the date of grant.

The fair value of restricted stock units is amortized on a straight-line basis through the statement of operations over the service period until the shares have vested.

The following table presents the restricted stock unit activity for the years ended December 31, 2021 and 2020:

In thousands (except per share amounts)

Weighted Average

Grant Date Fair

Outstanding as of January 1, 2021

Outstanding as of December 31, 2021

The Company recorded compensation expense in relation to restricted stock units of $ 13.9 million, $ 23.4 million, and $ 14.6 million for the years ended December 31, 2021, 2020, and 2019 respectively.

The following table presents the stock-based compensation expense related to stock-based awards for the years ended December 31, 2021, 2020, and 2019:

Research and development

Selling, general and administrative

Restructuring

Stock-based compensation expense

Employee Stock Purchase Plan

The ESPP is intended to qualify as an “employee stock purchase plan”

within the meaning of Section 423 of the Internal Revenue Code.

The maximum fair market value of stock which can be purchased by a participant in a calendar year is $ 25,000 .

Subject to certain exclusions, any employee of the Company’s U.S.

For the offering periods ended on the last business day on or before each of May 31, 2020 and November 30, 2020, the Company issued 123,608 shares and 223,545 shares, respectively, at a purchase price of $ 5.83 per share and $ 4.22 per share, respectively.

offering periods ended on the last business day on or before each of May 31, 2019 and November 30, 2019, the Company issued 47,358 shares and 75,673 shares, respectively, at a purchase price of $ 15.02 per share and $ 14.92 per share, respectively.

As of December 31, 2021, 1,818,273 shares were reserved for future issuance under the ESPP.

(11) Defined Contribution Plan

1 unchanged sentence

Under the 401(k) plan, employees may make contributions which are eligible for a discretionary percentage match, in cash, as defined in the 401(k) plan and determined by the Board of Directors.

The Company recognized $ 1.9 million, $ 1.7 million and $ 1.1 million of related compensation expense for the year ended December 31, 2021, 2020 and 2019 , respectively.

Company recognized $ 1.7 million, $ 1.9 million and $ 1.7 million of related compensation expense for the years ended December 31, 2022, 2021 and 2020 , respectively.

(12) Co-Promotion Agreement

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was eligible to receive $ 17.8 million in co-promotion tail payments, the present value of which $ 16.6 million, was fully accrued as of December 31, 2018.

As of December 31, 2021 a net payable to Kowa Pharmaceuticals America, Inc.

of $ 0.6 million was classified as current on the consolidated balance sheets, representing the remaining accrued co-promotion tail payments.

During the first quarter of 2022, the final co-promotion tail payment was made to Kowa Pharmaceuticals America, Inc.

As of December 31, 2021, the Company recognized a net payable to Kowa Pharmaceuticals America, Inc.

of $ 3.8 million, of which $ 3.2 million was classified as current on the consolidated balance sheets.

of $ 0.6 million was classified as current on the consolidated balance sheets, representing the remaining accrued co-promotion tail payments.

(13) Revenue Recognition

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Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established and which result from (a) trade allowances, such as invoice discounts for prompt pay and distributor fees, (b) estimated government and private payor rebates and chargebacks and discounts, such as Medicaid reimbursements, (c) reserves for expected product returns and (d) estimated costs of incentives that are offered within contracts between the Company and its distributors, health care providers, payors and other indirect customers relating to the Company’s sales of its product.

These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the distributor) or as a current liability (if the amount is payable to a party other than a distributor).

These reserves are based on individual contractual amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (distributor payments or credits) or as a current liability (payable to a non-distributor).

Where appropriate, these estimates take into consideration a range of possible outcomes which are probability-weighted for relevant factors such as the Company’s historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns.

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Actual amounts of consideration ultimately received may differ from the Company’s estimates.

If actual results in the future vary from the Company’s

estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known.

If actual results in the future vary from the Company’s estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known.

Trade Allowances:

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Rebates, Chargebacks and Discounts:

The Company contracts with Medicaid, Medicare, other government agencies and various private organizations, or collectively, Third-party Payors, so that VASCEPA will be eligible for purchase by, or partial or full reimbursement from, such Third-party Payors.

The Company contracts with Medicaid, Medicare, other government agencies and various private organizations, or collectively, Third-party Payors, so that VASCEPA will be eligible for purchase by, for partial or full reimbursement from, such Third-party Payors.

The Company estimates the rebates, chargebacks and discounts it will provide to Third-party Payors and deducts these estimated amounts from its gross product revenues at the time the revenues are recognized.

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The Company’s co-pay mitigation program is intended to reduce each participating patient’s portion of the financial responsibility for VASCEPA’s purchase price to a specified dollar amount.

Based upon the terms of the program and information regarding programs provided for similar specialty pharmaceutical products, the Company estimates the average co-pay mitigation amounts and the percentage of patients that it expects to participate in the program in order to establish its accruals for co-pay mitigation rebates.

Based upon the terms of the program and information regarding programs provided for similar specialty pharmaceutical products, the Company estimates the average co-pay mitigation amounts and the percentage of patients that it expects to participate in the program to establish its accruals for co-pay mitigation rebates.

These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in Accrued expenses and other current liabilities on the consolidated balance sheets.

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The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied.

At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development, regulatory and commercial milestones and any related constraint, and if necessary,

adjusts its estimate of the overall transaction price.

Any such adjustments are recorded on a cumulative catch-up basis, which would affect licensing revenues and earnings in the period of adjustment.

6 unchanged sentences

In June 2018, the Company entered into a collaboration with Mochida Pharmaceutical Co., Ltd., or Mochida, related to the development and commercialization of drug products and indications based on the active pharmaceutical ingredient in VASCEPA, the omega-3 acid, EPA, or eicosapentaenoic acid.

Among other terms in the agreement, the Company obtained an exclusive license to certain Mochida intellectual property to advance the Company’s interests in the United States and certain other territories and the parties will collaborate to research and develop new products and indications based on EPA for the Company’s commercialization in the United States and certain other territories.

Among other terms in the agreement, the Company obtained an exclusive license to

certain Mochida intellectual property to advance the Company’s interests in the United States and certain other territories and the parties will collaborate to research and develop new products and indications based on EPA for the Company’s commercialization in the United States and certain other territories.

The potential new product and indication opportunities contemplated under this agreement are currently in early stages of development.

1 unchanged sentence

In addition, the agreement provides for the Company to pay milestone payments upon the achievement of certain product development milestones and royalties on net sales of future products arising from the collaboration, if any.

In January 2021, the Company exercised certain rights under the agreement, resulting in a payment of $ 1.0 million to Mochida, which was recorded as Research and development expense in the consolidated statement of operations.

In January 2020 and December 2020, the Company exercised certain rights under the agreement, resulting in payments of $ 1.0 million, respectively, to Mochida, which were recorded as Research and development expense in the consolidated statement of operations.

In January 2022 and 2021, the Company exercised certain rights under the agreement, resulting in payments of $ 1.0 million, respectively, to Mochida, which was recorded as Research and development expense in the consolidated statement of operations.

Eddingpharm (Asia) Macao Commercial Offshore Limited

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The DCS Agreement may be terminated by either party in the event of a bankruptcy of the other party and for material breach, subject to customary cure periods.

In addition, at any time following the third anniversary of the first

commercial sale of a product in Mainland China, Edding has the right to terminate the DCS Agreement for convenience with 12 months’

In addition, at any time following the third anniversary of the first commercial sale of a product in Mainland China, Edding has the right to terminate the DCS Agreement for convenience with 12 months’

prior notice.

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In November 2020, the Company announced statistically significant topline results from the Phase 3 clinical trial of VASCEPA conducted by Edding, which is being used to seek regulatory approval in Mainland China.

Edding is also seeking regulatory approval of VASCEPA in Hong Kong.

The Company received approval of VASCEPA under the REDUCE-IT indication in Hong Kong in February 2022.

In addition to the non-refundable, up-front and regulatory milestone payments described above, the Company is entitled to receive certain regulatory and sales-based milestone payments of up to an additional $ 153.0 million as well as tiered double-digit percentage royalties on net sales of VASCEPA in the China Territory escalating to the high teens.

1 unchanged sentence

The amounts to be received upon achievement of the regulatory milestone events relate to the submission and approval for three indications, and range from $ 2.0 million to $ 15.0 million for a total of $ 33.0 million.

The sales-based milestone events occur when annual aggregate net sales of VASCEPA in the territory equals or exceeds certain specified thresholds, and range from $ 5.0 million to $ 50.0 million for a total of $ 120.0 million.

sales-based milestone events occur when annual aggregate net sales of VASCEPA in the territory equals or exceeds certain specified thresholds, and range from $ 5.0 million to $ 50.0 million for a total of $ 120.0 million.

Each such milestone payment shall be payable only once regardless of how many times the sales milestone event is achieved.

10 unchanged sentences

During the years ended December 31, 2022 and 2021, the Company recognized $ 0.6 million and $ 1.1 million, respectively, as licensing revenue related to the up-front and milestone payments received in connection with the Edding agreement.

From contract inception through December 31, 2021 and 2020, the Company recognized $ 7.1 million and $ 6.1 million, respectively, as licensing revenue under the DCS Agreement concurrent with the input measure of support hours provided by Amarin to Edding in achieving the combined development and regulatory performance obligation, which in the Company’s judgment is the best measure of progress towards satisfying this performance obligation.

From contract inception through December 31, 2022 and 2021, the Company recognized $ 7.7 million and $ 7.1 million, respectively, as licensing revenue under the DCS Agreement concurrent with the input measure of support hours provided by the Company to Edding in achieving the combined development and regulatory performance obligation, which in the Company’s judgment is the best measure of progress towards satisfying this performance obligation.

The remaining transaction price of $ 9.3 million and $ 9.8 million is recorded in deferred revenue as of December 31, 2022 and 2021 , respectively, on the consolidated balance sheets and will be recognized as revenue over the remaining period of 12 years .

The Company recognized net product revenue of $ 0.2 million and $ 0.3 million for the years ended December 31, 2022 and 2021, respectively, related to sales to Edding.

Biologix FZCo

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Under the agreement, HLS will be responsible for regulatory and commercialization activities and associated costs.

The Company is responsible for providing assistance towards local filings, supplying finished product under negotiated supply terms, maintaining intellectual property, and continuing the development and funding of REDUCE-IT related activities.

The Company is responsible for providing assistance towards local

filings, supplying finished product under negotiated supply terms, maintaining intellectual property, and continuing the development and funding of REDUCE-IT related activities.

Upon closing of the agreement, the Company received one-half of a non-refundable $ 5.0 million up-front payment, and received the remaining half on the six-month anniversary of the closing.

11 unchanged sentences

During the years ended December 31, 2022 and 2021, the Company recognized $ 0.7 million and $ 0.9 million, respectively, as licensing revenue related to up-front and milestone payments received in connection with the HLS agreement.

From the contract’s inception through December 31, 2021 and 2020, the Company has recognized $ 7.5 million and $ 6.6 million, respectively, as licensing revenue is recognized under the agreement concurrent with the input measure of support hours provided by Amarin to HLS in achieving this performance obligation, which in the Company’s judgment is the best measure of progress towards satisfying the combined development and regulatory performance obligation.

From the contract’s inception through December 31, 2022 and 2021, the Company has recognized $ 8.2 million and $ 7.5 million, respectively, as licensing revenue is recognized under the agreement concurrent with the input measure of support hours provided by the Company to HLS in achieving this performance obligation, which in the Company’s judgment is the best measure of progress towards satisfying the combined development and regulatory performance obligation.

The remaining transaction price of $ 5.6 million and $ 6.2 million is recorded in deferred revenue as of December 31, 2022 and 2021 , respectively, on the consolidated balance sheets and will be recognized as revenue over the remaining period of 8 years .

The Company recognized net product revenue of nil and $ 8.5 million for the years ended December 31, 2021 and 2020, respectively, related to sales to HLS.

The Company recognized net product revenue of $ 2.9 million and nil for the years ended December 31, 2022 and 2021, respectively, related to sales to HLS.

In February 2023, the Company entered into an agreement with CSL Seqirus to secure pricing and reimbursement, commercialize and distribute VAZKEPA in Australia and New Zealand.

The Company will receive an upfront payment of $ 0.5 million and be eligible to receive event-related milestone payments of approximately $ 8.0 million and additional product-related milestone payments of approximately $ 4.0 million.

The Company will be responsible for supplying finished product to CSL Seqirus at a profitable transfer price.

The following table presents changes in the balances of the Company’s contract assets and liabilities for years ended December 31, 2022 and 2021:

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Under the Lease, the Company paid monthly rent of approximately $ 0.1 million for the first year following the Commencement Date, and such rent increases by a nominal percentage every year following the first anniversary of the Commencement Date.

In addition, Amarin receives

certain abatements subject to the limitations in the Lease.

The operating lease liability is $ 10.3 million and $ 10.6 million and the operating lease right-of-use asset is $ 7.7 million and $ 8.1 million, as of December 31, 2021 and December 31, 2020, respectively.

The lease expense for the years ended December 31, 2021, December 31, 2020 and December 31, 2019 is approximately $ 2.2 million, $ 1.6 million and $ 1.5 million, respectively.

In addition, Amarin receives certain abatements subject to the limitations in the Lease.

On November 17, 2021, the Company entered into a lease agreement for new office space in Zug Switzerland, or the Zug Lease.

The Zug Lease commenced on February 1, 2022 , or the Zug Commencement Date, for a 5-year period, with one five-year renewal option.

Under the Zug Lease, the Company will pay annual rent of approximately $ 0.2 million for the first year following the Zug Commencement Date, and such rent increases by a nominal percentage every year following the first anniversary of the Zug Commencement Date.

On September 13, 2022, the Company entered into a lease agreement for new office space in Dublin, Ireland, or the Dublin Lease.

The Dublin Lease commenced on October 1, 2022 , or the Dublin Commencement Date, for a 2-year period.

Under the Dublin Lease, the Company will pay annual rent of approximately $ 0.4 million during the duration of the lease term.

In addition to the real estate leases, the Company leases various vehicles with terms ranging from month to month up to 36 months .

The operating lease liability is $ 11.6 million and $ 10.3 million and the operating lease right-of-use asset is $ 9.1 million and $ 7.7 million, as of December 31, 2022 and 2021, respectively.

The lease expense for the years ended December 31, 2022, 2021 and 2020 is approximately $ 2.8 million, $ 2.2 million and $ 1.6 million, respectively.

The table below depicts a maturity analysis of the Company’s undiscounted payments for its operating lease liabilities and their reconciliation with the carrying amount of lease liability presented in the statement of financial position as of December 31, 2022:

4 unchanged sentences

Long-term operating lease liability

The Company entered into a lease agreement for new office space in Zug, Switzerland.

The lease commenced on February 1, 2022 for a five year period.

Under the lease, the Company will pay rent of approximately $ 0.2 million per year.

The Company entered into a sublease agreement to lease a portion of the Bridgewater, New Jersey facility.

The lease commenced on February 1, 2023 , or the Sublease Commencement Date, for a seven and a half year period .

Under the sublease, the Company will receive monthly rent payments of approximately $ 0.1 million during the first year, and such rent increases by a nominal percentage every year following the first anniversary of the Sublease Commencement Date.

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.

What changed 10-K

Item 9A. Controls and Procedures