1 unchanged sentence
Evaluation of Disclosure Controls and Procedures
−Removed: We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is (i) recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and (ii) accumulated and communicated to our management, including our principal executive officer and principal financial officer, to allow timely decisions regarding required disclosure.
+Added: We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is (i) recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and (ii) accumulated and communicated to our management, including our principal executive officer and principal financial officer, to allow timely decisions regarding required disclosure.
As of December 31, 2023, 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).
−Removed: Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide
−Removed: only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
+Added: 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, 2023, our disclosure controls and procedures were effective at the reasonable assurance level.
−Removed: Management’s Report on Internal Control over Financial Reporting
+Added: Management’s Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting for our company.
16 unchanged sentences
Opinion on Internal Control over Financial Reporting
−Removed: We have audited Amarin Corporation plc’s internal control over financial reporting as of December 31, 2022, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria).
+Added: We have audited Amarin Corporation plc’s internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria).
In our opinion, Amarin Corporation plc (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2023, based on the COSO criteria .
−Removed: We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2022 and 2021, the related consolidated statements of operations, stockholders’
−Removed: equity and cash flows for each of the three years in the period ended December 31, 2022, and the related notes and our report dated March 1, 2023 expressed an unqualified opinion thereon.
+Added: We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2023 and 2022, the related consolidated statements of operations, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2023, and the related notes and our report dated February 29, 2024 expressed an unqualified opinion thereon.
Basis for Opinion
−Removed: The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Report on Internal Control over Financial Reporting.
−Removed: Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit.
+Added: The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Report on Internal Control over Financial Reporting.
+Added: Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit.
We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S.
5 unchanged sentences
Definition and Limitations of Internal Control Over Financial Reporting
−Removed: A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.
−Removed: A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company;
+Added: A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.
+Added: A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company;
(2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company;
−Removed: and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
+Added: and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.
2 unchanged sentences
Iselin, New Jersey
−Removed: March 1, 2023
+Added: February 29, 2024
Othe r Information
Entry into Rule 10b5-1 Trading Plans
−Removed: Our policy governing transactions in our securities by our directors, officers and employees permits our officers, directors and certain other persons to enter into trading plans complying with Rule 10b5-1 under the Exchange Act.
−Removed: Consistent with such regulation, our policy permits such plans to be entered into only when that person confirms they are not in possession of material non-public information.
−Removed: Our policy also requires a waiting period after a trading plan is created before shares can be traded under the plan.
−Removed: Our open trading windows are established in consultation with legal counsel.
−Removed: 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.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
43 unchanged sentences
February 29, 2012
−Removed: Description of Registrant’s Securities
+Added: Description of Registrant’s Securities
Annual Report on Form 10-K for the year ended December 31, 2019, as Exhibit 4.7
1 unchanged sentence
The Company 2011 Stock Option Plan*
−Removed: Annual Report on Form 20-F for the year ended December 31, 2006, as Exhibit 4.17
−Removed: March 5, 2007
−Removed: The Company 2011 Stock Option Plan*
Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2011, as Exhibit 10.4
23 unchanged sentences
August 2, 2017
−Removed: Amarin Corporation plc Management Incentive Compensation Plan*
−Removed: Annual Report on Form 10-K for the year ended December 31, 2010, as Exhibit 10.44
−Removed: March 16, 2011
Form of Incentive Stock Option Award Agreement *
38 unchanged sentences
April 29, 2021
−Removed: Employment Agreement between Jason Marks and Amarin Corporation plc, dated July 19, 2021*
−Removed: Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2021, as Exhibit 10.1
−Removed: November 3, 2021
Letter Agreement with Steve Ketchum, dated February 8, 2012*
7 unchanged sentences
March 16, 2012
−Removed: Letter Agreement, dated May 9, 2016, by and between Amarin Corporation plc and Michael Kalb*
−Removed: Current Report on Form 8-K dated June 30, 2016, as Exhibit 10.1
−Removed: June 30, 2016
Employment Agreement, dated April 20, 2018, by and between Amarin Corporation plc and Aaron Berg*
3 unchanged sentences
August 3, 2022
−Removed: Transition and Separation Agreement between Michael W.
−Removed: Kalb and Amarin Corporation plc, dated June 6, 2022*
−Removed: Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2022, as Exhibit 10.3
−Removed: August 3, 2022
−Removed: Transition Agreement between Jason M.
−Removed: Marks and Amarin Corporation plc, dated December 6, 2022*
−Removed: Filed herewith
API Commercial Supply Agreement, dated May 25, 2011, between Amarin Pharmaceuticals Ireland Ltd.
9 unchanged sentences
March 1, 2022
−Removed: 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 **
−Removed: Annual Report on Form 10-K for the year ended December 31, 2021, as Exhibit 10.38
−Removed: March 1, 2022
−Removed: 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
−Removed: Annual Report on Form 10-K for the year ended December 31, 2017, as Exhibit 10.66
−Removed: February 27, 2018
−Removed: Co-Promotion Agreement dated March 31, 2014, by and among the Company and Kowa Pharmaceuticals America, Inc.
−Removed: Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2014, as Exhibit 10.1
−Removed: First Amendment to the Co-Promotion Agreement of March 31, 2014 dated July 25, 2017, by and among Amarin Pharmaceuticals Ireland Limited, Amarin Pharma, Inc., and Kowa Pharmaceuticals America, Inc.
−Removed: Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2017, as Exhibit 10.1
−Removed: August 2, 2017
Development, Commercialization and Supply Agreement dated February 26, 2015, by and between Amarin Pharmaceuticals Ireland Limited, Amarin Pharma, Inc.
16 unchanged sentences
ST Shared Services LLC and Liberty Denver Wood LLC
−Removed: Filed herewith
+Added: Annual Report on Form 10-K for the year ended December 31, 2022, as Exhibit 10.44
+Added: March 1, 2023
Guaranty dated January 20, 2023, issued by MEH, Inc.
−Removed: Filed herewith
+Added: Annual Report on Form 10-K for the year ended December 31, 2022, as Exhibit 10.45
+Added: March 1, 2023
Sublease Agreement dated January 20, 2023, by and between Amarin Pharma, Inc.
and ST Shared Services LLC
−Removed: Filed herewith
+Added: Annual Report on Form 10-K for the year ended December 31, 2022, as Exhibit 10.46
+Added: March 1, 2023
License Agreement dated September 13, 2022, between Amarin Pharmaceuticals Ireland Ltd and Weston Office Solutions Ltd
+Added: Annual Report on Form 10-K for the year ended December 31, 2022, as Exhibit 10.47
+Added: March 1, 2023
+Added: Non-Employee Director Compensation Policy
+Added: Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2023, as Exhibit 10.1
+Added: August 2, 2023
+Added: Employment Agreement between Aaron D.
+Added: Berg and Amarin Corporation, plc.
+Added: dated April 13, 2023
+Added: Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2023, as Exhibit 10.2
+Added: August 2, 2023
+Added: CEO Employment Agreement between Patrick Holt and Amarin Corporation, plc.
+Added: dated July 18, 2023
+Added: Current Report on Form 8-K filed with the Commission on July 20, 2023, as Exhibit 10.1
+Added: July 20, 2023
+Added: Option Award Agreement (attached to Exhibit 10.1)
+Added: Current Report on Form 8-K filed with the Commission on July 20, 2023, as Exhibit 10.2
+Added: July 20, 2023
+Added: Amendment No.
+Added: 2 to the Amarin Corporation plc 2020 Stock Incentive Plan
+Added: Current Report on Form 8-K filed with the Commission on July 25, 2023, as Exhibit 10.2
+Added: July 25, 2023
+Added: Offer Letter with Jonathan Provoost, dated October 9, 2023*
Filed herewith
7 unchanged sentences
Filed herewith
−Removed: Certification of Senior Vice President and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) pursuant to Section 302 of Sarbanes-Oxley Act of 2002
+Added: Certification of Executive Vice President and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) pursuant to Section 302 of Sarbanes-Oxley Act of 2002
Filed herewith
−Removed: Certification of President and Chief Executive Officer (Principal Executive Officer) and Senior Vice President and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) pursuant to Section 906 of Sarbanes-Oxley Act of 2002
+Added: Certification of President and Chief Executive Officer (Principal Executive Officer) and Executive Vice President and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) pursuant to Section 906 of Sarbanes-Oxley Act of 2002
Furnished herewith
+Added: Compensation Recovery Plan
Inline XBRL Instance Document
Filed herewith
−Removed: Inline XBRL Taxonomy Extension Schema Document
−Removed: Filed herewith
−Removed: Inline XBRL Taxonomy Extension Calculation Linkbase Document
−Removed: Filed herewith
−Removed: Inline XBRL Taxonomy Extension Definition Linkbase Document
−Removed: Filed herewith
−Removed: Inline XBRL Taxonomy Extension Label Linkbase Document
−Removed: Filed herewith
−Removed: Inline XBRL Taxonomy Extension Presentation Linkbase Document
+Added: Inline XBRL Taxonomy Extension Schema with Embedded Linkbases Document
Filed herewith
9 unchanged sentences
AMARIN CORPORATION PLC
−Removed: /s/ Karim Mikhail
−Removed: Karim Mikhail
+Added: /s/ Patrick Holt
President and Chief Executive Officer
(Principal Executive Officer)
−Removed: March 1, 2023
−Removed: 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.
+Added: February 29, 2024
+Added: We, the undersigned officers and directors of the Registrant hereby severally constitute and appoint Patrick Holt 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.
−Removed: /s/ Karim Mikhail
−Removed: Karim Mikhail
+Added: /s/ Patrick Holt
Director, President and Chief
1 unchanged sentence
Executive Officer)
−Removed: March 1, 2023
+Added: February 29, 2024
/s/ Tom Reilly
−Removed: Senior Vice President and Chief
+Added: Executive Vice President and Chief
Financial Officer (Principal
Financial and Accounting Officer)
−Removed: March 1, 2023
−Removed: /s/ Adam Berger
−Removed: March 1, 2023
−Removed: /s/ Erin Enright
−Removed: March 1, 2023
−Removed: /s/ Jan van Heek
−Removed: March 1, 2023
−Removed: /s/ Geraldine Murphy
−Removed: Geraldine Murphy
−Removed: March 1, 2023
−Removed: /s/ Kristine Peterson
−Removed: March 1, 2023
−Removed: Kristine Peterson
−Removed: /s/ Murray Stewart D.M., F.R.C.P.
−Removed: Murray Stewart D.M., F.R.C.P.
−Removed: March 1, 2023
−Removed: /s/ Alfonso Zulueta
−Removed: Alfonso Zulueta
−Removed: March 1, 2023
+Added: February 29, 2024
+Added: /s/ Patrice Bonfiglio
+Added: Patrice Bonfiglio
+Added: February 29, 2024
+Added: /s/ Paul Cohen, M.D.
+Added: Paul Cohen, M.D.
+Added: February 29, 2024
+Added: /s/ Mark DiPaolo
+Added: February 29, 2024
+Added: February 29, 2024
+Added: /s/ Odysseas Kostas, M.D.
+Added: February 29, 2024
+Added: Odysseas Kostas, M.D.
+Added: /s/ Louis Sterling III.
+Added: Louis Sterling III.
+Added: February 29, 2024
+Added: February 29, 2024
+Added: /s/ Oliver O'Connor
+Added: February 29, 2024
+Added: Oliver O'Connor
AMARIN CORPORATION PLC
4 unchanged sentences
Consolidated Statements of Operations for the years ended December 31, 2023, 2022 and 2021
−Removed: Consolidated Statements of Stockholders’
−Removed: Equity for the years ended December 31, 2022, 2021 and 2020
+Added: Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2023, 2022 and 2021
Consolidated Statements of Cash Flows for the years ended December 31, 2023, 2022 and 2021
5 unchanged sentences
Opinion on the Financial Statements
−Removed: We have audited the accompanying consolidated balance sheets of Amarin Corporation plc (the Company) as of December 31, 2022 and 2021, the related consolidated statements of operations, stockholders’
−Removed: equity and cash flows for each of the three years in the period ended December 31, 2022, and the related notes (collectively referred to as the “consolidated financial statements”).
+Added: We have audited the accompanying consolidated balance sheets of Amarin Corporation plc (the Company) as of December 31, 2023 and 2022, the related consolidated statements of operations, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2023, and the related notes (collectively referred to as the “consolidated financial statements”).
In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2023, in conformity with U.S.
generally accepted accounting principles.
−Removed: We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, 2022, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated March 1, 2023 expressed an unqualified opinion thereon.
+Added: We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated February 29, 2024 expressed an unqualified opinion thereon.
Basis for Opinion
−Removed: These financial statements are the responsibility of the Company’s management.
−Removed: Our responsibility is to express an opinion on the Company’s financial statements based on our audits.
+Added: These financial statements are the responsibility of the Company’s management.
+Added: Our responsibility is to express an opinion on the Company’s financial statements based on our audits.
We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S.
15 unchanged sentences
The Company estimates variable consideration resulting from product returns based on quantitative and qualitative data from various internal and external sources.
−Removed: Auditing management’s estimate of product returns was complex and judgmental due to the significant estimation required to determine inventory in the distribution channel that will not ultimately be sold to patients and healthcare providers and will be returned.
+Added: Auditing management’s estimate of product returns was complex and judgmental due to the significant estimation required to determine inventory in the distribution channel that will not ultimately be sold to patients and healthcare providers and will be returned.
Sales into the distribution channel could exceed market demand.
How We Addressed the Matter in Our Audit
−Removed: We obtained an understanding, evaluated the design and tested the operating effectiveness of the controls over the Company’s estimation process for product returns including inventory in the distribution channel.
−Removed: These procedures included controls over management’s review of the inputs used and assumptions applied in the returns reserve calculation and channel inventory analysis.
−Removed: To test the estimated product return reserve, we performed audit procedures that included, among others, testing management’s historical return rate calculation and testing the completeness and accuracy of sales and returns data used in the calculation.
+Added: We obtained an understanding, evaluated the design and tested the operating effectiveness of the controls over the Company’s estimation process for product returns including inventory in the distribution channel.
+Added: These procedures included controls over management’s review of the inputs used and assumptions applied in the returns reserve calculation and channel inventory analysis.
+Added: To test the estimated product return reserve, we performed audit procedures that included, among others, testing management’s historical return rate calculation and testing the completeness and accuracy of sales and returns data used in the calculation.
We also compared product expiration dates in the calculation to the related quality control documentation.
−Removed: We assessed the historical accuracy of management’s estimate and performed analytical procedures to assess the correlation of monthly sales to distributors and monthly patient prescriptions.
−Removed: In addition, we assessed the Company’s quarterly analysis of inventory held at various stages in the distribution channel.
+Added: We assessed the historical accuracy of management’s estimate and performed analytical procedures to assess the correlation of monthly sales to distributors and monthly patient prescriptions.
+Added: In addition, we assessed the Company’s quarterly analysis of inventory held at various stages in the distribution channel.
We confirmed prescription data directly with a third party, confirmed contract terms directly with significant customers, and tested credit memos issued subsequent to year-end for recording in the proper period.
1 unchanged sentence
/s/ Ernst & Young LLP
−Removed: We have served as the Company’s auditor since 2014.
+Added: We have served as the Company’s auditor since 2014.
Iselin, New Jersey
−Removed: March 1, 2023
+Added: February 29, 2024
AMARIN CORPORATION PLC
14 unchanged sentences
Intangible asset, net
−Removed: LIABILITIES AND STOCKHOLDERS’
+Added: LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
9 unchanged sentences
Commitments and contingencies (Note 7)
−Removed: Stockholders’
+Added: Stockholders’ Equity:
Common stock, £ 0.50 par, unlimited authorized;
6 unchanged sentences
Accumulated deficit
−Removed: Total stockholders’
−Removed: TOTAL LIABILITIES AND STOCKHOLDERS’
+Added: Total stockholders’ equity
+Added: TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
See the notes to the consolidated financial statements.
16 unchanged sentences
Interest expense
−Removed: Other (expense) income, net
+Added: Other income (expense), net
(Loss) income from operations before taxes
5 unchanged sentences
AMARIN CORPORATION PLC
−Removed: CONSOLIDATED STATEMENTS O F STOCKHOLDERS’
+Added: CONSOLIDATED STATEMENTS O F STOCKHOLDERS’ EQUITY
(in thousands, except share amounts)
December 31, 2021
−Removed: Conversion of Series A
−Removed: Convertible Preferred Stock, net
−Removed: ( 289,317,460
−Removed: Issuance of common stock under
−Removed: employee stock purchase plan
−Removed: Exercise of stock options
−Removed: Vesting of restricted stock units
−Removed: Stock-based compensation
−Removed: Loss for the period
−Removed: December 31, 2020
Issuance of common stock under employee stock purchase plan
+Added: Issuance of common stock for milestone payment
Exercise of stock options
1 unchanged sentence
Stock-based compensation
−Removed: Income for the period
+Added: Loss for the period
December 31, 2022
Issuance of common stock under employee stock purchase plan
−Removed: Issuance of common stock for milestone payment
Exercise of stock options
12 unchanged sentences
Depreciation and amortization
−Removed: Amortization of investments
+Added: (Accretion) amortization of investments
Stock-based compensation
−Removed: Amortization of debt discount and debt issuance costs
Amortization of intangible asset
4 unchanged sentences
Interest receivable
−Removed: Accrued interest payable
Deferred revenue
1 unchanged sentence
Other long-term liabilities
−Removed: Net cash used in operating activities
+Added: Net cash provided by (used in) operating activities
CASH FLOWS FROM INVESTING ACTIVITIES:
−Removed: Sale and maturities of securities
+Added: Maturities of securities
Purchases of securities
−Removed: Investment in website development costs
−Removed: Disposal (purchases) of furniture, fixtures and equipment
−Removed: Net cash provided by (used in) investing activities
+Added: Investment in software and website development costs
+Added: (Purchases) disposal of furniture, fixtures and equipment
+Added: Net cash (used in) provided by investing activities
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock under employee stock purchase plan
−Removed: Proceeds from exercise of stock options, net of transaction costs
−Removed: Payment of transaction costs for conversion of preferred stock
−Removed: Payment on debt from royalty-bearing instrument
+Added: Proceeds from exercise of stock options
Taxes related to stock-based awards
−Removed: Net cash used in financing activities
+Added: Net cash provided by (used in) financing activities
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH
7 unchanged sentences
Initial recognition of operating lease right-of-use asset
−Removed: Conversion of Series A Convertible Preferred Stock into common stock
+Added: Initial recognition of furniture, fixtures and equipment lease
See the notes to the consolidated financial statements.
4 unchanged sentences
Amarin Corporation plc, or Amarin, or the Company, is a pharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular, or CV, health and reduce CV risk.
−Removed: 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.
−Removed: 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.
−Removed: The Company’s operations outside of the U.S.
−Removed: and Europe are in early stages of development with reliance on third-party commercial partners in select geographies.
−Removed: The Company’s commercialized product, VASCEPA ® (icosapent ethyl), was approved by the U.S.
+Added: The Company is commercialized in the United States, or the U.S, under the brand name VASCEPA ® (icosapent ethyl).
+Added: The Company has launched commercial operations in certain European countries, such as the United Kingdom, or the UK, and Spain and continues pre-launch commercial activities throughout the rest of Europe.
+Added: The Company’s operations outside of the U.S.
+Added: and Europe are in varying stages of development and commercialization with reliance on third-party commercial partners in select geographies, including China and Canada.
+Added: The Company’s lead product, VASCEPA, was first 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, or the MARINE indication.
−Removed: 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.
−Removed: In 2020, following our unsuccessful appeals of a court ruling in favor of two generic drug companies, Dr.
+Added: In January 2013, the Company launched 1-gram size VASCEPA in the U.S.
+Added: and in October 2016, introduced a 0.5-gram capsule size.
+Added: On December 13, 2019, the U.S.
+Added: 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.
+Added: VASCEPA is approved by the U.S.
+Added: FDA as an adjunct to maximally tolerated statin therapy for reducing persistent cardiovascular risk in select high risk patients, or the REDUCE-IT indication.
+Added: On March 30, 2020, following conclusion of a trial in late January 2020, the U.S.
+Added: District Court for the District of Nevada, or the Nevada Court, issued a ruling in favor of two generic drug companies, Dr.
Reddy’s Laboratories, Inc., or Dr.
−Removed: 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.
+Added: 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 MARINE indication.
+Added: The Company sought appeals of the Nevada Court judgment up to the United States Supreme Court, but the Company was unsuccessful.
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.
−Removed: market with a 1-gram capsule:
FDA MARINE Indication Approval
+Added: 1-gram Launch Date
+Added: 0.5-gram Launch Date
Hikma Pharmaceuticals USA Inc.
November 2020
−Removed: Reddy’s Laboratories, Inc.
+Added: Reddy’s Laboratories, Inc.
Teva Pharmaceuticals USA, Inc.
1 unchanged sentence
September 2022
−Removed: (1) - Teva launched a 0.5-gram capsule in September 2022 and a 1-gram capsule in January 2023.
+Added: Zydus Lifesciences
+Added: Strides Pharma
+Added: September 2023
+Added: December 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 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.
−Removed: 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’
−Removed: On December 7, 2022, the Company announced that Swissmedic approved VAZKEPA in Switzerland.
+Added: 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.
Collectively CHMP, EMA, EC and MHRA are referred to herein as the European Regulatory Authorities.
−Removed: In November 2020, the Company announced topline results from the Phase 3 clinical trial of VASCEPA conducted by the Company’s partner in China.
−Removed: On February 9, 2021, the Company announced that regulatory review processes for approval of VASCEPA in Mainland China and Hong Kong had commenced.
−Removed: 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.
+Added: In November 2020, the Company announced topline results from the Phase 3 clinical trial of VASCEPA conducted by the Company’s partner in China.
+Added: On June 1, 2023, the Company announced the National Medical Products Administration, or NMPA, granted approval for VASCEPA under the MARINE indication and launched commercially in October 2023.
On February 23, 2022, the Hong Kong Department of Health concluded their evaluation and approved the use of VASCEPA under the REDUCE-IT indication.
−Removed: The Company currently has strategic collaborations to develop and commercialize VASCEPA in select territories outside the United States.
−Removed: 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.
+Added: The Company currently has strategic collaborations to develop and commercialize VASCEPA in select territories outside the United States and Europe.
+Added: Amarin is responsible for supplying VASCEPA to all markets in which the product is sold, including the United States, and Europe, as well as in countries 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.
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The consolidated financial statements included herein have been prepared by the Company in accordance with accounting principles generally accepted in the United States and pursuant to the rules and regulations of the Securities and Exchange Commission, or the SEC.
−Removed: The consolidated financial statements reflect all adjustments of a normal and recurring nature that, in the opinion of management, are necessary to present fairly the Company’s financial position, results of operations and cash flows for the periods indicated.
−Removed: The preparation of the Company’s consolidated financial statements in conformity with U.S.
+Added: The consolidated financial statements reflect all adjustments of a normal and recurring nature that, in the opinion of management, are necessary to present fairly the Company’s financial position, results of operations and cash flows for the periods indicated.
+Added: The preparation of the Company’s consolidated financial statements in conformity with U.S.
Generally Accepted Accounting Principles, or GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period.
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All intercompany accounts and transactions have been eliminated in consolidation.
−Removed: The accompanying consolidated financial statements of the Company and subsidiaries have been prepared on a basis which assumes that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business, as well as the ongoing global pandemic, COVID-19.
−Removed: At December 31, 2022, the Company had Total assets of $ 886.2 million, of which $ 310.6 million consisted of cash and liquid short-term and long-term investments.
−Removed: More specifically, the Company had Current assets of $ 689.1 million, including Cash and cash equivalents of $ 217.7 million, Short-term investments of $ 91.7 million, Accounts receivable, net, of $ 131.0 million and Inventory of $ 228.7 million.
−Removed: In addition, at December 31, 2022, the Company had Long-term investments of $ 1.3 million and Long-term inventory of $ 163.6 million.
+Added: The accompanying consolidated financial statements of the Company and subsidiaries have been prepared on a basis which assumes that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business.
+Added: At December 31, 2023, the Company had total assets of $ 831.7 million, of which $ 320.7 million consisted of cash and liquid short-term investments.
+Added: More specifically, the Company had current assets of $ 725.0 million, including cash and cash equivalents of $ 199.3 million, short-term investments of $ 121.4 million, accounts receivable, net, of $ 133.6 million and current inventory of $ 258.6 million.
+Added: In addition, at December 31, 2023, the Company had long-term inventory of $ 77.6 million.
At December 31, 2023 , the Company had no debt outstanding.
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Use of Forecasted Financial Information in Accounting Estimates
−Removed: The use of forecasted financial information is inherent in many of the Company’s accounting estimates including, but not limited to, determining the estimated fair values of intangible assets, evaluating the need for valuation allowances for deferred tax assets, and assessing the Company’s ability to continue as a going concern.
−Removed: Such forecasted financial information is comprised of numerous assumptions regarding the Company’s future revenues, cash flows, and operational results.
+Added: The use of forecasted financial information is inherent in many of the Company’s accounting estimates including, but not limited to, determining the estimated fair values of intangible assets, evaluating the need for valuation allowances for deferred tax assets, and assessing the Company’s ability to continue as a going concern.
+Added: Such forecasted financial information is comprised of numerous assumptions regarding the Company’s future revenues, cash flows, and operational results.
Management believes that its financial forecasts are reasonable and appropriate based upon current facts and circumstances.
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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.
−Removed: 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.
+Added: 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.
−Removed: For a complete discussion of accounting for net product revenue and licensing revenue, see Note 13—Revenue Recognition.
+Added: For a complete discussion of accounting for net product revenue and licensing revenue, see Note 12—Revenue Recognition.
Distribution Costs
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All customer accounts are actively managed and no losses in excess of amounts reserved are currently expected.
−Removed: however, the Company is monitoring the potential negative impact of COVID-19 on the Company’s customers’
−Removed: ability to meet their financial obligations.
The following table summarizes the impact of accounts receivable reserves on the gross trade accounts receivable balances at December 31, 2023 and 2022:
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Trade allowances
−Removed: Allowance for doubtful accounts
Accounts receivable, net
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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.
−Removed: 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.
−Removed: 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.
+Added: The Company classifies inventory as long-term inventory when consumption of the inventory is expected beyond the next 12 months.
+Added: The Company classifies finished goods expected to be sold within the next 12 months 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.
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for the first indication in 2012, the expanded label in 2019 and marketing authorization in Europe in 2021.
−Removed: These assets are amortized over its estimated useful life on a straight-line basis.
−Removed: See Note 7—Commitments and Contingencies for further information regarding other obligations related to the acquisition of Laxdale.
+Added: These assets are
+Added: amortized over its estimated useful life on a straight-line basis.
+Added: 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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and infrastructure costs, including facilities costs and depreciation expense.
−Removed: In addition, research and development costs include the costs of product supply received from suppliers when such receipt by the Company is prior to regulatory approval of the supplier, as well as license fees related to the Company’s strategic collaboration with Mochida Pharmaceutical Co., Ltd., or Mochida.
+Added: In addition, research and development costs include the costs of product supply received from suppliers when such receipt by the Company is prior to regulatory approval of the supplier, as well as license fees related to the Company’s strategic collaboration with Mochida Pharmaceutical Co., Ltd., or Mochida.
Selling, General and Administrative Costs
The Company charges selling, general and administrative costs to operations as incurred.
−Removed: Selling, general and administrative costs include salaries and benefits, stock-based compensation expense, and costs of programs and infrastructure necessary for the general conduct of the Company’s business, including those incurred as a result of the commercialization of VASCEPA in the United States.
+Added: Selling, general and administrative costs include salaries and benefits, stock-based compensation expense, and infrastructure necessary for the general conduct of the Company’s business, including those incurred as a result of the commercialization of VASCEPA in the United States and Europe.
Deferred tax assets and liabilities are recognized for the future tax consequences of differences between the carrying amounts and tax bases of assets and liabilities and operating loss carryforwards and other tax attributes using enacted rates expected to be in effect when those differences reverse.
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Tax benefits for uncertain tax positions are based on a determination of whether a tax benefit taken by the Company in its tax filings or positions is more likely than not to be realized, assuming that the matter in question will be decided based on its technical merits.
−Removed: The Company’s policy is to record interest and penalties in the provision for income taxes, as applicable.
+Added: The Company’s policy is to record interest and penalties in the provision for income taxes, as applicable.
The Company regularly assesses its ability to realize deferred tax assets.
−Removed: Changes in historical earnings performance, future earnings projections, and changes in tax laws, among other factors, may cause the Company to adjust its valuation allowance on deferred tax assets, which would impact the Company’s income tax expense in the period in which it is determined that these factors have changed.
−Removed: Excess tax benefits and deficiencies that arise upon vesting or exercise of share-based payments are recognized as an income tax benefit and expense, respectively, in the consolidated statement of operations.
+Added: Changes in historical earnings performance, future earnings projections, and changes in tax laws, among other factors, may cause the Company to adjust its valuation allowance on deferred tax assets, which would impact the Company’s income tax expense in the period in which it is determined that these factors have changed.
+Added: Excess tax benefits and deficiencies that arise upon vesting or exercise of stock-based payments are recognized as an income tax benefit and expense, respectively, in the consolidated statement of operations.
Excess income tax benefits are classified as cash flows from operating activities and cash paid to taxing authorities arising from the withholding of shares from employees are classified as cash flows from financing activities.
−Removed: The Company’s and its subsidiaries’
−Removed: income tax returns are periodically examined by various tax authorities, including the Internal Revenue Service, or IRS, and states.
−Removed: The Company is currently under audit by the IRS for the Company’s 2018 U.S.
−Removed: income tax return and by the New Jersey Department of Treasury for the years 2012 to 2015 .
+Added: The Company’s and its subsidiaries’ income tax returns are periodically examined by various tax authorities, including the Internal Revenue Service, or IRS, and state tax authorities.
+Added: The Company is currently under audit by the IRS for its 2018 and 2019 U.S.
+Added: income tax returns.
+Added: An audit by the New Jersey Department of Treasury for the years 2012 to 2015 was closed in April 2023.
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.
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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, 2023, 2022, and 2021 are as follows:
−Removed: Net (loss) income —basic and diluted
−Removed: Weighted average shares outstanding—basic
+Added: Net (loss) income —basic and diluted
+Added: Weighted average shares outstanding—basic
Effect of dilutive securities:
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Restricted stock and restricted stock units
−Removed: Weighted average shares outstanding—diluted
−Removed: Net (loss) earnings per share—basic
−Removed: Net (loss) earnings per share—diluted
+Added: Weighted average shares outstanding—diluted
+Added: Net (loss) earnings per share—basic (1)
+Added: Net (loss) earnings per share—diluted (1)
+Added: (1) Excluding the licensing revenue change in estimate and Medicaid change in estimate, both discussed in Note 12 – Revenue Recognition, net loss per share basic and diluted for the year ended December 31, 2023 would have been $( 0.21 ).
For the years ended December 31, 2023, 2022 and 2021, 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:
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The Company reassesses the probability of achievement of the performance conditions each reporting period.
+Added: For awards with market conditions, the Company recognizes compensation expense based on the grant date fair value of the award, using the Monte Carlo Model, over the requisite service 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.
−Removed: See Note 9—Stock Incentive Plans and Stock-Based Compensation for further discussion.
+Added: See Note 9—Stock Incentive Plans and Stock-Based Compensation for further discussion.
Concentration of Credit Risk
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The Company maintains substantially all of its cash and cash equivalents and short-term and long-term investments, in financial institutions believed to be of high-credit quality.
−Removed: A significant portion of the Company’s sales are to wholesalers in the pharmaceutical industry.
+Added: A significant portion of the Company’s sales are to wholesalers in the pharmaceutical industry.
The Company monitors the creditworthiness of customers to whom it grants credit terms and has not experienced any credit losses.
The Company does not require collateral or any other security to support credit sales.
−Removed: Three customers individually accounted for 10% or more of the Company’s
−Removed: gross product sales.
+Added: Three customers individually accounted for 10% or more of the Company’s gross product sales.
Customers A, B, and C accounted for 36 % , 28 % , and 29 % , respectively, of gross product sales for the year ended December 31, 2023 and represented 36 % , 18 % , and 38 % , respectively, of the gross accounts receivable balance as of December 31, 2023.
1 unchanged sentence
The Company has not experienced any significant write-offs of its accounts receivable.
−Removed: All customer accounts are actively managed and no losses are currently expected;
−Removed: however, the Company is monitoring the potential negative impact of COVID-19 on the Company’s customers’
−Removed: ability to meet their financial obligations.
+Added: All customer accounts are actively managed and no losses in excess of amounts reserved are currently expected.
Concentration of Suppliers
The Company has contractual freedom to source the API for VASCEPA and to procure other services supporting its supply chain and has entered into supply agreements with multiple suppliers.
−Removed: The Company’s supply of product for commercial sale and clinical trials is dependent upon relationships with third-party manufacturers and suppliers.
+Added: The Company’s supply of product for commercial sale and clinical trials is dependent upon relationships with third-party manufacturers and suppliers.
The Company cannot provide assurance that its efforts to procure uninterrupted supply of VASCEPA to meet market demand will continue to be successful or that it will be able to renew current supply agreements on favorable terms or at all.
−Removed: Significant alteration to or disruption or termination of the Company’s current supply chain, including as a result of COVID-19, or the Company’s failure to enter into new and similar agreements in a timely fashion, if needed, could have a material adverse effect on its business, condition (financial and other), prospects or results of operations.
+Added: Significant alteration to or disruption or termination of the Company’s current supply chain, or the Company’s failure to enter into new and similar agreements in a timely fashion, if needed, could have a material adverse effect on its business, condition (financial and other), prospects or results of operations.
The Company currently has manufacturing agreements with multiple independent API manufacturers and several independent API encapsulators and packagers for VASCEPA manufacturing.
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dollars at period-end exchange rates.
−Removed: Gains and losses from the remeasurement are included in Other (expense) income, net in the consolidated statements of operations.
−Removed: For transactions settled during the applicable period, gains and losses are included in Other (expense) income, net in the consolidated statements of operations.
−Removed: Certain amounts payable pursuant to supply contracts are denominated in currencies other than the U.S.
−Removed: 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.
+Added: Gains and losses from the remeasurement are included in Other income (expense), net in the consolidated statements of operations.
+Added: For transactions settled during the applicable period, gains and losses are included in Other income (expense), net in the consolidated statements of operations.
+Added: Certain amounts payable are denominated in currencies other than the U.S.
+Added: The Company recorded a foreign currency loss within the Other income (expense), net on the consolidated statement of operations of $ 2.6 million, $ 0.7 million and $ 0.6 million for each of the years ended December 31, 2023, 2022, and 2021 , respectively.
Fair Value of Financial Instruments
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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:
−Removed: Level 1—Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.
−Removed: Level 2—Inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (i.e., interest rates, yield curves, etc.) and inputs that are derived principally from or corroborated by observable market data by correlation or other means (market corroborated inputs).
−Removed: Level 3—Unobservable inputs that reflect the Company’s estimates of the assumptions that market participants would use in pricing the asset or liability.
+Added: Level 1—Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.
+Added: Level 2—Inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (i.e., interest rates, yield curves) and inputs that are derived principally from or corroborated by observable market data by correlation or other means (market corroborated inputs).
+Added: Level 3—Unobservable inputs that reflect the Company’s estimates of the assumptions that market participants would use in pricing the asset or liability.
The Company develops these inputs based on the best information available, including its own data.
−Removed: The following tables present information about the estimated fair value of the Company’s assets and liabilities as of December 31, 2022 and 2021 and indicate the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value:
+Added: The following tables present information about the estimated fair value of the Company’s assets and liabilities as of December 31, 2023 and 2022 and indicate the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value:
December 31, 2023
−Removed: Money Market Fund
Treasury Shares
+Added: Money Market Fund
Agency Securities
−Removed: Corporate Bonds
−Removed: Commercial Paper
Repo Securities
−Removed: Asset Backed Securities
−Removed: Certificate of Deposit
−Removed: Non-US Government
December 31, 2022
Money Market Fund
−Removed: Treasury Shares
−Removed: Corporate Bonds
Commercial Paper
−Removed: Repo Securities
−Removed: Asset Backed Securities
+Added: Corporate Bonds
Certificate of Deposit
+Added: Repo Securities
+Added: Treasury Shares
+Added: Agency Securities
Non-US Government
−Removed: The carrying amount of the Company’s cash and cash equivalents approximates fair value because of their short-term nature.
+Added: Asset Backed Securities
+Added: The carrying amount of the Company’s cash and cash equivalents approximates fair value because of their short-term nature.
The 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 the purchase of 90 days or less.
−Removed: The Company’s held-to-maturity investments are stated at amortized cost, which approximates fair value.
+Added: The Company’s investments are stated at amortized cost, which approximates fair value.
The Company does not intend to sell these investment securities and the contractual maturities are not greater than 24 months .
−Removed: Those with original maturities greater than 90 days and less than 12 months are included in short-term investments on its consolidated balance sheet.
+Added: Those with original maturities greater than 90 days and maturities 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.
−Removed: Unrealized gains or losses on held-to-maturity securities are not recognized until maturity, except other-than-temporary unrealized losses which are recognized in earnings in the period incurred.
+Added: Unrealized gains or losses are not recognized until maturity, except other-than-temporary unrealized losses which are recognized in earnings in the period incurred.
The Company evaluates securities with unrealized losses to determine whether such losses are other than temporary.
−Removed: 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.
+Added: The unrealized gain or loss for the years ended December 31, 2023 and December 31, 2022 was a gain of less than $ 0.1 million and a loss of $ 0.4 million, respectively.
Interest on investments is reported in interest income.
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The Company currently operates in one business segment, which is the development and commercialization of VASCEPA.
−Removed: A single management team that reports to the Company’s chief decision-maker, who is the Chief Executive Officer, comprehensively manages the business.
+Added: A single management team that reports to the Company’s chief decision-maker, who is the Chief Executive Officer, comprehensively manages the business.
Accordingly, the Company does not have separately reportable segments.
Restructuring
+Added: The Company identifies a restructuring event as a program that is planned and controlled by management, and materially changes either the scope of the Company's business or the manner in which that business is conducted.
+Added: The accounting for involuntary termination benefits that are provided pursuant to a one-time benefit arrangement are accounted for under ASC 420 – Exit or Disposal Cost Obligations whereas involuntary termination benefits that are part of an ongoing written or substantive plan are accounted for under ASC 712 – Compensation – Nonretirement Postemployment Benefits.
+Added: The Company accrues a liability for termination benefits under ASC 712 when it is probable that a liability has been incurred and the amount can be reasonably estimated and under ASC 420 when the termination benefits are communicated.
+Added: In June 2023, the Company approved and subsequently announced on July 18, 2023, an Organizational Restructuring Plan, or ORP, to right-size and strengthen the Company.
+Added: As part of the plan, the Company completed the elimination of its entire U.S.
+Added: sales field force, as well as a reduction of approximately 30% of the non-sales positions.
+Added: The Company maintained its managed care and trade organization to support U.S.
+Added: commercial efforts.
+Added: During the year ended December 31, 2023, the Company recognized approximately $ 11.0 million within restructuring expense on the consolidated statement of operations related to the reduction in force, substantially all of which are cash expenditures.
+Added: The Company continued to assess its contractual supplier purchase obligations and has taken steps to amend supplier agreements to align supply arrangements with current and future market demand.
+Added: As a result of the ongoing assessment, the Company recognized $ 39.2 million and $ 18.1 million during the years ended December 31, 2023 and 2022, respectively, within cost of goods sold - restructuring inventory on the consolidated statement of operations.
+Added: 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.
+Added: On June 6, 2022, the Company announced a Comprehensive Cost Reduction Plan, or CRP, which included an organizational restructuring plan to address the shifts within the Company’s U.S.
+Added: As part of the plan, the Company completed a reduction of its U.S.
+Added: field force from approximately 300 sales representatives to approximately 75 sales representatives.
+Added: 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 reduction in force, substantially all of which was cash expenditures.
+Added: On August 19, 2022, the Company announced that after the conclusion of the fourth and final round of negotiations in Germany 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.
+Added: As a result, the Company discontinued its German business operations effective September 1, 2022.
+Added: During the year ended December 31, 2022, the Company recognized approximately $ 4.2 million within restructuring expense on the condensed consolidated statement of operations, substantially all of which was cash expenditures.
On September 22, 2021, the Company announced a Go-to-Market strategy for VASCEPA.
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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.
−Removed: 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.
−Removed: As part of the plan, the Company completed a reduction of its U.S.
−Removed: field force from approximately 300 sales representatives to approximately 75 sales representatives.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: As a result of the negotiation outcome with the GKV-SV, the Company discontinued its German business operations effective September 1, 2022.
−Removed: The Company recognized approximately $ 4.2 million within Restructuring expense on the consolidated statement of operations, substantially all of which are cash expenditures.
−Removed: 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):
+Added: The following table sets forth the components of the Company's restructuring charges for the years ended December 31, 2023, 2022 and 2021:
For the Year Ended December 31,
4 unchanged sentences
Stock forfeitures
−Removed: Total restructuring costs incurred
+Added: Total restructuring cash obligations incurred
The following table shows the change in restructuring liability which is included within accrued expenses and other current liabilities:
1 unchanged sentence
Balance at December 31, 2022
−Removed: Costs incurred
+Added: Restructuring cash obligations incurred
Balance at December 31, 2023
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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.
−Removed: 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.
+Added: 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 consolidated financial position, results of operations, and cash flows, or do not apply to the Company’s operations.
(3) Intangible Asset
−Removed: 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.
+Added: Intangible asset consists of internal-use software, 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.
−Removed: For the year ended December 31, 2022 , the Company capitalized $ 0.8 million of costs associated with the development of a global company website.
+Added: For the year ended December 31, 2023 , the Company capitalized $ 0.3 million of costs associated with the implementation of internal-use software.
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.
7 unchanged sentences
Amortization expense for the years ended December 31, 2023 and 2022 was $ 2.8 million and $ 2.5 million, respectively.
−Removed: Estimated future amortization expense, based upon the Company’s intangible asset, as of December 31, 2022 is as follows:
+Added: Estimated future amortization expense as of December 31, 2023 is as follows:
Year Ending December 31,
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Finished goods
−Removed: 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.
−Removed: As of December 31, 2022 and 2021, we had $ 163.6 million and $ 121.3 million of Long-term inventory, respectively.
+Added: Inventory (1)
+Added: (1) Total inventory consists of both current inventory and long-term inventory.
+Added: During the year ended December 31, 2023 , approximately $ 5.1 million of inventory was expensed through cost of goods sold for both product dating and non-product dating unsellable inventory.
+Added: During the year ended December 31, 2022 approximately $ 9.6 million of finished goods were expensed through cost of goods sold related to unsellable inventory not related to product dating.
+Added: As of December 31, 2023 and 2022, the Company had $ 77.6 million and $ 163.6 million of long-term inventory, respectively, as consumption is expected beyond the Company's operating cycle of 12 months.
(5) Property, Plant and Equipment
−Removed: Property, plant and equipment as of December 31, 2022 and 2021 consist of the following:
+Added: Property, plant and equipment as of December 31, 2023 and 2022 consists of the following:
Useful Life (in years)
9 unchanged sentences
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.
−Removed: Depreciation expense for the years ended December 31, 2022, 2021, and 2020 were $ 0.6 million, annually.
+Added: Depreciation expense for the year ended December 31, 2023 was $ 0.2 million and for the years ended December 31 2022, and 2021 was $ 0.6 million, respectively.
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.
7 unchanged sentences
Accrued revenue allowances
+Added: Accrued restructuring
Accrued expenses and other current liabilities
(7) Commitments and Contingencies
−Removed: Litigation –
+Added: Amarin accrues a liability for legal contingencies when it believes that it is both probable that a liability has been incurred and that it can reasonably estimate the amount of the loss.
+Added: Amarin reviews these accruals and adjusts them to reflect ongoing negotiations, settlements, rulings, advice of legal counsel and other relevant information.
+Added: To the extent new information is obtained and Amarin’s views on the probable outcomes of claims, suits, assessments, investigations or legal proceedings change, changes in Amarin’s accrued liabilities would be recorded in the period in which such determination is made.
+Added: For the matters referenced below, the amount of liability is not probable nor can the amount be reasonably estimated;
+Added: therefore, accruals have not been made.
+Added: In addition, in accordance with the relevant authoritative guidance, for matters in which the likelihood of material loss is at least reasonably possible, Amarin provides disclosure of the possible loss or range of loss.
+Added: If a reasonable estimate cannot be made, however, Amarin will provide disclosure to that effect.
+Added: Litigation – U.S.
On March 30, 2020, the Nevada Court, ruled in favor of two generics companies, Hikma and Dr.
−Removed: Reddy’s, in Amarin’s patent litigation related to its ANDAs that sought U.S.
+Added: Reddy’s, in Amarin’s patent litigation related to its ANDAs that sought U.S.
FDA approval for sale of generic versions of VASCEPA for the original indication of VASCEPA as an adjunct to diet to reduce TG levels in adult patients with severe (>500 mg/dL) hypertriglyceridemia.
2 unchanged sentences
On October 2, 2020, the Company filed a combined petition for panel rehearing or rehearing en banc.
−Removed: On November 4, 2020, the Company’s rehearing and en banc petitions were denied.
−Removed: On February 11, 2021, Amarin filed a petition for a writ of certiorari with the United States Supreme Court to ask the Court to hear the Company’s appeal in this litigation, which was denied on June 18, 2021.
+Added: On November 4, 2020, the Company’s rehearing and en banc petitions were denied.
+Added: On February 11, 2021, Amarin filed a petition for a writ of certiorari with the United States Supreme Court to ask the Court to hear the Company’s appeal in this litigation, which was denied on June 18, 2021.
On May 22, 2020 and August 10, 2020, Hikma and Dr.
−Removed: Reddy’s, respectively, received U.S.
+Added: Reddy’s, respectively, received U.S.
FDA approval to market its generic versions of VASCEPA.
During the ANDA litigation, the Company reached agreements with Teva and Apotex, under which they received royalty-free license agreements to promote a generic version of icosapent ethyl in the U.S.
−Removed: under certain circumstances, one of which circumstances was achieved when the Federal Circuit upheld the ruling by the Nevada Court and Hikma launched its generic version of icosapent ethyl.
+Added: under certain circumstances, one
+Added: of which circumstances was achieved when the Federal Circuit upheld the ruling by the Nevada Court and Hikma launched its generic version of icosapent ethyl.
On September 11, 2020, and June 30, 2021, Teva and Apotex, respectively, received U.S.
2 unchanged sentences
In June 2021, Dr.
−Removed: Reddy’s announced the price and launched its generic version of icosapent ethyl.
+Added: 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.
5 unchanged sentences
The active pharmaceutical ingredient in VASCEPA is difficult and time consuming to manufacture, often requires considerable advanced planning and long-term financial commitment, including to manufacturing infrastructure such as dedicated facilities, to ensure sufficient capacity is available when needed.
−Removed: 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.
+Added: 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.
In November 2020, the Company filed a patent infringement lawsuit against Hikma in the United States District Court in Delaware.
6 unchanged sentences
On October 13, 2022, the district court granted final judgement on the aspect of the litigation relating to the Company and Hikma.
−Removed: Company has appealed the decision of the district court.
+Added: The 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.
1 unchanged sentence
As has been a practice in the generic pharmaceutical industry, on April 27, 2021 and February 21, 2023, Dr.
−Removed: 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.
−Removed: The complaints also includes a related state law tortious interference claim.
+Added: Reddy’s and Hikma, respectively, filed complaints against the Company in the United States District Court for the District of New Jersey, Civil action No.
+Added: 21-cv-10309 and No.
+Added: 23-cv-01016, alleging various antitrust violations stemming from alleged anticompetitive practices related to the supply of active pharmaceutical ingredient of VASCEPA.
+Added: The DRL complaints also includes a related state law tortious interference claim.
Damages sought include recovery for alleged economic harm to Dr.
−Removed: Reddy’s and Hikma's, payors and consumers, treble damages and other costs and fees.
−Removed: Injunctive relief against the alleged violative activities is also being sought by Dr.
−Removed: Reddy’s and Hikma.
+Added: Reddy’s and to Hikma respectively, treble damages, other costs and fees and injunctive relief against the alleged violative activities.
Amarin believes it has valid defenses and will vigorously defend against the claims.
+Added: Such litigation can be lengthy, costly and could materially affect and disrupt our business.
In March 2021, Amarin received a civil investigative demand, or CID, from the U.S.
5 unchanged sentences
Civil False Claims Act, in relation to the sale and marketing of VASCEPA by the Company and its previous co-marketing partner, Kowa Pharmaceuticals America, Inc.
−Removed: The Company believes such contact from the governments may have been prompted by a generic competitor.
−Removed: The inquiries require the Company to produce documents and answer written questions, or interrogatories, relevant to specified time periods.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 21-12061, 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.
−Removed: Amarin is a defendant in a class action lawsuit filed by The International Union of Operating Engineers Locals 137, 137A, 137B, 137C, 137R, on behalf of indirect purchasers, in the District Court for the District of New Jersey, Civil Action No.
−Removed: 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.
−Removed: 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.
−Removed: Amarin is a defendant in a class action lawsuit filed by Teamsters Health & Welfare Fund of Philadelphia and Vicinity, on behalf of indirect purchasers, in the District Court for the District of New Jersey, Civil Action No.
−Removed: 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.
−Removed: 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.
−Removed: Welfare Fund, on behalf of indirect purchasers, in the District Court of New Jersey, Civil Action No.
−Removed: 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.
−Removed: These cases have been consolidated into In re Vascepa Antitrust Litigation (Indirect Purchasers), Civil Action No.
−Removed: 21-12061, in the District Court for the District of New Jersey.
−Removed: 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.
−Removed: 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.
−Removed: This case has been coordinated with the consolidated indirect purchaser case above as In re Vascepa Antitrust Litigation (Direct Purchasers), Civil Action No.
−Removed: 21-12747, in the District Court for the District of New Jersey.
−Removed: Such antitrust litigation and investigations can be lengthy, costly and could materially affect and disrupt the Company’s business.
−Removed: The Company cannot predict when these matters will be resolved, their outcome or their potential impact on the Company’s business.
+Added: Amarin is cooperating with the government agencies regarding these two investigations, or the Investigations, and concluded document production and interrogatory responses in mid-2023.
+Added: We cannot predict when these investigations will be resolved, the outcome of the investigations or their potential impact on the Company’s business.
+Added: Amarin is named as a defendant in six antitrust class action lawsuits in the District Court for the District of New Jersey, as displayed in the table below.
+Added: Each of the six antitrust class action lawsuits allege 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.
+Added: Civil Action #
+Added: Direct/Indirect Purchasers
+Added: Uniformed Fire Officers Association Family Protection Plan Local 854
+Added: Indirect Purchaser
+Added: Uniformed Fire Officers Association for Retired Fire Officers Family Protection Plan
+Added: Indirect Purchaser
+Added: The International Union of Operating Engineers Locals 137, 137A, 137B, 137C, 137R
+Added: Indirect Purchaser
+Added: KPH Healthcare Services, Inc.
+Added: Direct Purchaser
+Added: Local 464A United Food and Commercial Workers Union Welfare Service Benefit Fund
+Added: Indirect Purchaser
+Added: Teamsters Health & Welfare Fund of Philadelphia and Vicinity
+Added: Indirect Purchaser
+Added: Such antitrust litigation and antitrust investigations can be lengthy, costly and could materially affect and disrupt the Company’s business.
+Added: The Company cannot predict when these matters will be resolved, their outcome or their potential impact on the Company’s business.
If a government determines that Amarin has violated antitrust law, the Company could be subject to significant civil fines and penalties.
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.
−Removed: Litigation –
−Removed: 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.
−Removed: District Court for the District of New
−Removed: Jersey, Debendra Sharma v.
−Removed: Amarin Corporation plc, John F.
−Removed: Thero and Steven Ketchum, No.
−Removed: 2:19-cv-06601 (D.N.J.
−Removed: On March 12, 2019, another purported investor filed a substantially similar lawsuit captioned Richard Borghesi v.
−Removed: Amarin Corporation plc, John F.
−Removed: Thero and Steven Ketchum, No.
−Removed: 3:19-cv-08423 (D.N.J.
−Removed: March 12, 2019).
−Removed: On May 14, 2019 the court consolidated the cases under the caption In re Amarin Corporation PLC Securities Litigation, No.
−Removed: 3:19-cv-06601 and appointed two other purported shareholders, Dan Kotecki and the Gaetano Cecchini Living Trust, as Co-Lead Plaintiffs.
−Removed: Co-Lead Plaintiffs filed a consolidated amended complaint, or Amended Complaint, on July 22, 2019 that added as defendants the Company’s former chief medical officer and the Company’s former chief executive officer.
−Removed: The Amended Complaint alleged that from September 24, 2018 to November 9, 2018 the Company misled investors by releasing topline results for the REDUCE-IT study without disclosing data on biomarker increases in the placebo group as compared with baseline measurement.
−Removed: The Amended Complaint alleged that these data suggest that the mineral oil placebo used in the REDUCE-IT study may have interfered with statin absorption in the placebo group, which they alleged may have increased adverse outcomes in the placebo group.
−Removed: The Amended Complaint further alleged that these purported misrepresentations and omissions inflated the share price.
−Removed: Based on these allegations, the suit asserted claims under the Securities Exchange Act of 1934 and sought unspecified monetary damages and attorneys’
−Removed: fees and costs.
−Removed: On March 29, 2021, the court granted the Company’s motion to dismiss this litigation for failure to state a valid claim.
−Removed: The litigation was dismissed without prejudice, giving the plaintiffs the right to file an amended complaint.
−Removed: Plaintiffs in this action did not file an amended complaint within the permitted filing deadline.
−Removed: Plaintiffs filed a notice of appeal of the motion to dismiss ruling, which has been denominated In re:
−Removed: PLC , case number 21-2071 (3d Cir.).
−Removed: On June 14, 2022, the Court of Appeals for the Third Circuit affirmed the dismissal of the matter by the trial district court.
+Added: Litigation – Other
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 former chief financial officer in the U.S.
3 unchanged sentences
1:21-cv-19212 (D.N.J.
−Removed: 21, 2021) and a subsequent case, Dorfman v.
+Added: A subsequent case, Dorfman v.
Amarin Corporation plc, et al., No.
1 unchanged sentence
10, 2021), was filed in November 2021.
−Removed: 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.
−Removed: The plaintiffs filed an amended complaint on January 13, 2023 that added as a defendant the Company's former general counsel.
−Removed: 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.
+Added: 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.
+Added: The complaints in these actions are nearly identical and allege that the Company misled investors by allegedly downplaying the risk associated with the Company's ANDA litigation described above and the risk that certain of the Company's patents related to the MARINE indication would be invalidated.
Based on these allegations, plaintiff alleges that he purchased securities at an inflated share price and brings claims under the Securities and Exchange Act of 1934 seeking unspecified monetary damages and attorneys' fees and costs.
+Added: In October 2022, the court consolidated the cases and appointed a lead plaintiff for the putative class.
+Added: On January 13, 2023, lead plaintiff filed an amended complaint that also named the former general counsel, and again alleged that the Company made false statements regarding the ANDA Litigation as well as about the REDUCE-IT indication and VASCEPA’s financial prospects resulting from REDUCE-IT.
+Added: All Defendants have moved to dismiss the amended complaint and the motion remains pending.
The Company believes it has valid defenses and will vigorously defend against the claims but cannot predict the outcome.
The Company is unable to reasonably estimate the loss exposure, if any, associated with these claims.
−Removed: 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.
−Removed: District Court for the District of New Jersey, Gary Schader v.
−Removed: Amarin Corporation plc, John F.
−Removed: Thero, Michael W.
−Removed: Kalb, Lars G.
−Removed: Ekman, Jan Van Heek, Karim Mikhail, Patrick J.
−Removed: O'Sullivan, Per Wold-Olsen, Kristine Peterson, David Stack, and Joseph S.
−Removed: Zakrzewski, No.
−Removed: 3:22-cv-02017 (D.N.J.
−Removed: 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.
−Removed: 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.
−Removed: On July 1, 2022, the plaintiff voluntarily dismissed this matter.
+Added: On March 29, 2023, purported investors in the Company’s publicly traded securities filed a derivative lawsuit, naming as defendants the Company’s former general counsel, the Company’s trial counsel for the ANDA litigation, and the Company as nominal defendant, in the Superior Court of New Jersey, Law Division, Monmouth County, captioned Anne Abramson, John Lissandrello, Georgette Appiano, and Andrew Bondarowicz v.
+Added: Amarin Corporation plc, Covington & Burling, LLP, Joseph T.
+Added: Kennedy, and John Does A-Z , No.
+Added: MON-L-000984-23 (N.J.
+Added: The complaint alleged that the defendants failed to exercise appropriate diligence and due care in their conduct of the ANDA litigation.
+Added: Based on those allegations, the complaint alleged that the defendants committed legal malpractice and sought monetary damages and attorneys’ fees and costs.
+Added: On April 8, 2023, the plaintiffs voluntarily dismissed this case without prejudice.
+Added: On March 31, 2023, the Company’s former chief executive officer, Karim Mikhail, filed a complaint against the Company and certain of its affiliates in the Superior Court of New Jersey, Law Division – Somerset County, captioned Mikhail v.
+Added: Amarin Corporation, plc (Docket No.
+Added: SOM-L-000366-23), concerning Mr.
+Added: Mikhail’s alleged “constructive termination” from the Company.
+Added: The complaint seeks unspecified damages arising from claims for breaches of his employment agreement, Executive Severance and Change of Control Plan, and the implied covenant of good faith and fair dealing.
+Added: On April 3, 2023, the case moved to the United States District Court for the District of New Jersey (Civ.
+Added: 3:23-cv-01856).
+Added: On June 30, 2023, all defendants moved to dismiss this case without prejudice.
+Added: The Company believes it has valid defenses and will vigorously defend against the claims but cannot predict the outcome.
+Added: The Company is unable to reasonably estimate the loss exposure, if any, associated with these claims.
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.
5 unchanged sentences
The Company has incurred certain costs associated with the qualification of product produced by these suppliers.
−Removed: 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.
−Removed: business as a result of the generic competition.
−Removed: As part of this plan, the Company has reviewed its contractual supplier purchase obligations and has entered into agreements with
−Removed: some suppliers to amend supplier agreements to align supply arrangements with current and future market demand.
−Removed: 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.
−Removed: 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.
+Added: The Company continues to negotiate with contract suppliers to align its supply arrangements with current and future global demand which may result in additional costs to the Company.
+Added: As of the date of filing this Annual Report, the Company has a total of approximately $ 37.0 million in future contractual purchase obligations without consideration to ongoing discussions with other suppliers.
+Added: In addition, the Company has total obligations of $ 186.5 million contingent on either certain suppliers obtaining regulatory approval in Europe or pricing reimbursement in certain European countries not occurring by June 30, 2024.
+Added: During 2023, the Company determined that it was probable that the Company would not be able to obtain pricing reimbursement in certain countries outlined within renegotiated supply agreements by June 30, 2024.
+Added: The Company's reasonable estimate of the liability is a range between $ 8.0 million and $ 15.8 million, with no amount within that range a better estimate than any other amount;
+Added: accordingly, an $ 8.0 million provision was recognized in cost of goods sold - restructuring inventory on the consolidated statement of operations.
+Added: The ultimate resolution of the matter could result in up to an additional $ 7.8 million of the amount accrued.
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 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.
−Removed: 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).
+Added: 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, 2023, 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 $ 6.4 million as of December 31, 2023) for the potential market approval.
−Removed: 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 .
+Added: The Company has no provision for any of these obligations, except the $ 8.0 million provision noted above, since the amounts are either not paid or payable as of December 31, 2023 .
+Added: On January 10, 2024, the Company announced plans to initiate a share repurchase program to purchase up to $ 50.0 million of the Company's ordinary shares held in the form of American Depository Shares.
+Added: The implementation of the share repurchase program will require shareholder approval as well as UK High Court approval, as required under UK company law.
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.
2 unchanged sentences
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.
−Removed: Refer to Note 9—Stock Incentive Plans and Stock Based Compensation for discussion of shares issued under the Company’s employee stock purchase plan.
+Added: Refer to Note 9—Stock Incentive Plans and Stock Based Compensation for discussion of shares issued under the Company’s employee stock purchase plan.
Incentive Equity Awards
−Removed: The Company issues incentive equity awards, including incentive and non-qualified stock options and restricted stock units, under the Amarin Corporation plc 2020 Stock Incentive Plan, or the 2020 Plan, which is the successor to the Amarin Corporation plc 2011 Stock Incentive Plan, as amended, or the 2011 Plan, and the Amarin Corporation plc 2002 Stock Option Plan, as amended, or the 2002 Plan, and together with the 2020 Plan and 2011 Plan, the Plans.
−Removed: Refer to Note 9—Stock Incentive Plans and Stock Based Compensation for further information regarding the Company’s incentive equity plans and awards.
+Added: The Company issues incentive equity awards, including incentive and non-qualified stock options and restricted stock units, under the Amarin Corporation plc 2020 Stock Incentive Plan, or the 2020 Plan, which is the successor to the Amarin Corporation plc 2011 Stock Incentive Plan, as amended, or the 2011 Plan, and the Amarin Corporation plc 2002 Stock Option Plan, as amended, or the 2002
+Added: Plan, and together with the 2020 Plan and 2011 Plan, the Plans.
+Added: Refer to Note 9—Stock Incentive Plans and Stock Based Compensation for further information regarding the Company’s incentive equity plans and awards.
The following table summarizes the aggregate number of stock options and restricted stock units, or RSUs, outstanding under the 2020 Plan as of December 31, 2023:
9 unchanged sentences
Common shares issued in settlement of vested RSUs
−Removed: Shares retained for settlement of employee tax obligations ─
+Added: Shares retained for settlement of employee tax obligations ─ RSUs
Common shares issued in settlement of vested Performance-Based RSUs (1)
−Removed: Shares retained for settlement of employee tax obligations ─
−Removed: Performance-Based RSUs
−Removed: (1) Performance-based RSUs vested in connection with the achievement of certain regulatory and sales performance conditions associated with the REDUCE-IT clinical trial and subsequent revenue growth.
−Removed: These performance-based RSUs have fully vested as of August 2021.
+Added: Shares retained for settlement of employee tax obligations ─ Performance-Based RSUs
+Added: (1) Performance-based RSUs vested in connection with the achievement of certain performance conditions.
+Added: These performance-based RSUs will primarily vest over a three-year period based on continuous service from the grant date.
During the years ended December 31, 2023 and 2022, the Company granted a total of 5,456,800 and 3,065,000 stock options, respectively, and 8,227,800 and 9,069,500 RSUs, respectively, to employees under the Plans.
1 unchanged sentence
Also during 2023 and 2022, the Company granted a total of 1,368,800 and 1,919,500 RSUs, respectively, to employees under the Plans that vest upon the achievement of specified performance conditions.
−Removed: In addition, during the years ended December 31, 2022 and 2021, the Company granted a total of 1,973,124 and 278,271 stock options, respectively, and 1,597,955 and 218,000 RSUs, respectively, to members of the Company’s Board of Directors under the Plans.
−Removed: The RSUs vest in equal installments over a three-year period upon the earlier of the anniversary of the grant date or the Company’s annual general meeting of shareholders in such anniversary year.
−Removed: The stock options vest in full upon the earlier of the one-year anniversary of the grant date or the Company’s annual general meeting of shareholders in such anniversary year.
+Added: In addition to the grants noted above, in connection with the implementation of a retention program in July 2023, the Company granted a total of 3,978,300 stock options to employees under the 2020 Plan.
+Added: The options vest 50 % on both January 1, 2024 and January 1, 2025, respectively.
+Added: Also in July 2023, the Company granted 5,000,000 stock options to Patrick Holt in connection with his appointment as President and Chief Executive Officer, which will vest upon achievement of specified stock price conditions for the Company.
+Added: During the years ended December 31, 2023 and 2022, the Company granted a total of 3,853,025 and 1,973,124 stock options, respectively, and 1,392,257 and 1,597,955 RSUs, respectively, to members of the Company’s Board of Directors under the Plans.
+Added: The RSUs vest in equal installments over a three-year period upon the earlier of the anniversary of the grant date or the Company’s annual general meeting of shareholders in such anniversary year.
+Added: The stock options vest in full upon the earlier of the one-year anniversary of the grant date or the Company’s annual general meeting of shareholders in such anniversary year.
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
−Removed: 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.
−Removed: 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.
+Added: 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.
+Added: 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.
−Removed: 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.
−Removed: 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.
−Removed: The 2020 Plan is administered by the Remuneration Committee of the Company’s Board of Directors and expires on July 13, 2030.
+Added: 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.
+Added: 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
+Added: grants under the 2020 Plan.
+Added: The 2020 Plan is administered by the Remuneration Committee of the Company’s Board of Directors and expires on July 13, 2030.
Stock Options
−Removed: Under the terms of the Plans, stock options typically vest over a four-year period and expire after a ten-year term.
−Removed: 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.
+Added: Under the terms of the Plans, stock options typically vest over a four-year period and expire after a 10-year term.
+Added: 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, 2023:
7 unchanged sentences
The total grant date fair value of options vested during the years ended December 31, 2023, 2022, and 2021 was $ 8.2 million, $ 16.6 million, and $ 21.1 million, respectively.
+Added: Included within the above table is the 5,000,000 market-based stock option award with a weighted average grant date fair value of $ 0.37 .
During the years ended December 31, 2023, 2022 and 2021, the Company received proceeds from the exercise of options of $ 1.9 million, $ 0.1 million, and $ 2.9 million, respectively.
−Removed: 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.
+Added: The total intrinsic value of options exercised during the years ended December 31, 2023, 2022, and 2021 was $ 0.4 million , nominal and $ 4.9 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, 2023, options have $ 11.7 million of unrecognized stock-based compensation expense with such expense expected to be recognized over a weighted-average period of approximately 2.8 years.
−Removed: The fair value of stock options on the date of grant was estimated using the Black-Scholes option pricing model.
+Added: The fair value of stock options on the date of grant was estimated using the Black-Scholes option pricing model except for the market-based option awards which used the Monte Carlo option pricing model.
Use of a valuation model requires management to make certain assumptions with respect to selected model inputs, which include:
7 unchanged sentences
• Expected volatility:
−Removed: Expected stock price volatility was calculated based on the historical volatility of the Company’s common stock over the expected life of the option.
−Removed: For 2022, 2021, and 2020, the Company used the following assumptions to estimate the fair value of share-based payment awards:
+Added: Expected stock price volatility for the Black-Scholes model was calculated based on the historical volatility of the Company’s common stock over the expected life of the option.
+Added: For the Monte Carlo model, expected stock price volatility was calculated based on the historical volatility of both the Company's common stock and comparable company's common stock over the expected life of the option.
+Added: For 2023, 2022, and 2021, the Company used the following assumptions to estimate the fair value of share-based payment awards under the Black-Scholes model:
Risk-free interest rate
5 unchanged sentences
Expected volatility
+Added: 101 % - 104 %
+Added: The Company used the following assumptions to estimate the fair value of share-based payment awards under the Monte Carlo model in 2023:
+Added: Risk-free interest rate
+Added: 4.06 % - 4.09 %
+Added: Expected dividend yield
+Added: Expected option life (years)
+Added: Expected volatility
+Added: 42.5 % - 43.00 %
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.
−Removed: The grant date fair value of the stock options, net of an estimated forfeiture rate is amortized straight-line over the awards’
−Removed: vesting periods or respective requisite service periods and is adjusted for actual forfeitures over such period.
+Added: 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 $ 6.8 million, $ 14.8 million and $ 23.0 million for the years ended December 31, 2023, 2022, and 2021, respectively.
10 unchanged sentences
The Company recorded compensation expense in relation to restricted stock units of $ 9.8 million, $ 11.4 million and $ 13.9 million, for the years ended December 31, 2023, 2022, and 2021, respectively.
+Added: The total grant date fair value of restricted stock units vested during the years ended December 31, 2023, 2022, and 2021 was $ 16.3 million, $ 14.3 million and $ 23.8 million, respectively.
As of December 31, 2023, restricted stock units have $ 14.9 million of unrecognized stock-based compensation expense with such expense to be recognized over a weighted-average period of approximately 1.8 years.
5 unchanged sentences
Employee Stock Purchase Plan
−Removed: 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.
−Removed: The ESPP is intended to qualify as an “employee stock purchase plan”
−Removed: within the meaning of Section 423 of the Internal Revenue Code.
+Added: 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.
+Added: 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.
−Removed: Subject to certain exclusions, any employee of the Company’s U.S.
+Added: 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.
−Removed: 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.
+Added: 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, 2023 and November 30, 2023, the Company issued 205,861 shares and 113,749 shares, respectively, at a purchase price of $ 1.01 per share and $ 0.66 per share, respectively.
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.
−Removed: 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.
+Added: 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.
As of December 31, 2023, 1,041,967 shares were reserved for future issuance under the ESPP.
1 unchanged sentence
The Company recognizes interest and penalties related to uncertain tax positions within the provision for income taxes.
−Removed: 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.
+Added: The total amount of unrecognized tax benefits that would affect the Company’s effective tax rate if recognized is $ 8.9 million and $ 8.2 million as of December 31, 2023 and 2022, respectively.
The Company recognized interest related to uncertain tax positions of $ 0.7 million and $ 0.5 million for the years ended December 31, 2023 and 2022 , respectively.
2 unchanged sentences
Beginning uncertain tax benefits
−Removed: Prior year—increases
−Removed: Prior year—decreases
−Removed: Current year—increases
+Added: Prior year—increases
+Added: Prior year—decreases
+Added: Current year—increases
Ending uncertain tax benefits
1 unchanged sentence
The Company remains subject to tax examinations in the following jurisdictions as of December 31, 2023:
−Removed: United States—Federal
−Removed: United States—State
+Added: United States—Federal
+Added: United States—State
United Kingdom
The Company does no t expect any gross liabilities to expire in 2024 based on statutory lapses or audits.
−Removed: The components of income (loss) from operations before taxes were as follows for the years ended December 31, 2022, 2021 and 2020:
+Added: The components of (loss) income from operations before taxes were as follows for the years ended December 31, 2023, 2022 and 2021:
United States
2 unchanged sentences
The provision for income taxes shown in the accompanying consolidated statements of operations consists of the following for the years ended December 31, 2023, 2022 and 2021:
−Removed: United States—Federal
−Removed: United States—State
+Added: United States—Federal
+Added: United States—State
Total current
−Removed: United States—Federal
−Removed: United States—State
+Added: United States—Federal
+Added: United States—State
Change in valuation allowance
6 unchanged sentences
Nondeductible employee compensation
−Removed: Stock option/RSU windfall (shortfall)
+Added: Stock option/RSU windfall
ISO disqualifying disposition windfall
1 unchanged sentence
Tax return to provision adjustments
−Removed: Net operating loss carryback
Foreign exchange
7 unchanged sentences
However, for Amarin Pharmaceuticals Ireland Limited, a wholly-owned subsidiary of Amarin Corporation plc, the Company applied the 12.5 % Irish trading tax rate.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: On March 27, 2020, the Coronavirus Aid, Relief and Economic Security Act, or CARES Act, was enacted in the United States.
−Removed: Among other provisions, the CARES Act allows businesses to carry back net operating losses arising in years 2018 to 2020 to the five prior tax years.
−Removed: We recorded an income tax benefit of $ 2.5 million for the year ended December 31, 2020 as a result of these loss carrybacks and an income tax benefit of nil for the years ended December 31, 2022 and 2021, respectively.
+Added: 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.
In April 2016, the Company adopted ASU No.
3 unchanged sentences
Previously, such amounts were recognized as an increase and decrease in additional paid-in capital.
−Removed: This aspect of the standard was adopted prospectively, and accordingly the provisions for income taxes for the years ended December 31, 2022, 2021 and 2020 includes $ 0.6 million, $ 0.1 million and $ 3.7 million of excess tax benefits, respectively, arising from share-based payments during the period.
+Added: This aspect of the standard was adopted prospectively, and accordingly the provisions for income taxes for the years ended December 31, 2023, 2022 and 2021 includes nil , $ 0.6 million and $ 0.1 million of excess tax benefits, respectively, arising from share-based payments during the period.
The income tax effect of each type of temporary difference comprising the net deferred tax asset as of December 31, 2023 and 2022 is as follows:
12 unchanged sentences
Depreciation and amortization
−Removed: Other liabilities
Total deferred tax liabilities
8 unchanged sentences
During 2023, the Company recorded adjustments to its deferred tax accounts related to the impact of foreign exchange rate changes and to reconcile the financial statement accounts to the amounts expected to result in future income and deductions under local law, primarily as it relates to Irish net operating losses and deferred taxes for stock compensation.
−Removed: 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.
+Added: 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.
net operating loss carryforwards of $ 959.9 million, which do not expire.
−Removed: 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.
−Removed: 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.
+Added: The total net operating loss carryforwards increased by approximately $ 125.6 million from the prior year primarily as a result of current year loss generated by the Company’s U.S.
+Added: subsidiaries, the impact of foreign exchange rate changes and adjustments to reconcile to the amount reported on the filed 2021 foreign tax returns.
In addition, the Company has U.S.
3 unchanged sentences
As of December 31, 2023 , there are no earnings that have been retained indefinitely for reinvestment by foreign subsidiary;
−Removed: therefore, no provision has been made for income taxes that would be payable upon the distribution of such earnings or the recovery of the Company’s investment in its subsidiaries as the amount of the related unrecognized deferred income tax liability is zero .
+Added: therefore, no provision has been made for income taxes that would be payable upon the distribution of such earnings or the recovery of the Company’s investment in its subsidiaries as the amount of the related unrecognized deferred income tax liability is zero .
The Company's and its subsidiaries' income tax returns are periodically examined by various taxing authorities.
−Removed: The Company is currently under audit by the IRS for the Company’s 2018 U.S.
−Removed: income tax return, by the New Jersey Department of Treasury for the years 2012 to 2015 and by the New York Department of Finance for the years 2018 and 2019.
+Added: The Company is currently under audit by the IRS for the Company’s 2018 U.S.
+Added: income tax return and by the New York Department of Finance for the years 2018 and 2019.
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.
3 unchanged sentences
Company recognized $ 2.7 million, $ 1.7 million and $ 1.9 million of related compensation expense for the years ended December 31, 2023, 2022 and 2021 , respectively.
−Removed: (12) Co-Promotion Agreement
−Removed: On March 31, 2014, the Company entered into a Co-Promotion Agreement, or the Agreement, with Kowa Pharmaceuticals America, Inc.
−Removed: related to the commercialization of VASCEPA capsules in the United States.
−Removed: The Company and Kowa Pharmaceuticals America, Inc.
−Removed: intentionally designed the Agreement to naturally end as of December 31, 2018 and mutually agreed not to renew the Agreement.
−Removed: During 2018, which was the last year of the co-promotion of VASCEPA by Kowa Pharmaceuticals America, Inc., the Company incurred expense for co-promotion tail payments which are calculated as a percentage of the 2018 co-promotion fee, which was eighteen and a half percent ( 18.5 %) of VASCEPA gross margin in 2018.
−Removed: The accrued tail payments are paid over three years with declining amounts each year.
−Removed: Kowa Pharmaceuticals America, Inc.
−Removed: 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.
−Removed: During the first quarter of 2022, the final co-promotion tail payment was made to Kowa Pharmaceuticals America, Inc.
−Removed: As of December 31, 2021, the Company recognized a net payable to Kowa Pharmaceuticals America, Inc.
−Removed: of $ 0.6 million was classified as current on the consolidated balance sheets, representing the remaining accrued co-promotion tail payments.
(12) Revenue Recognition
−Removed: The Company sells VASCEPA principally to a limited number of major wholesalers, as well as selected regional wholesalers and specialty pharmacy providers in the United States and Europe, or collectively, its distributors or its customers, that in turn resell VASCEPA to retail pharmacies for subsequent resale to patients and healthcare providers.
+Added: The Company sells VASCEPA principally to a limited number of major wholesalers, as well as selected regional wholesalers and specialty pharmacy providers in the United States and Europe, or collectively, its distributors or its customers, most of whom in turn resell VASCEPA to retail pharmacies for subsequent resale to patients and healthcare providers.
Patients are required to have a prescription in order to purchase VASCEPA.
−Removed: In addition to distribution agreements with distributors, the Company enters into arrangements with health care providers and payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks and discounts with respect to the purchase of the Company’s product.
−Removed: Revenues from product sales are recognized when the distributor obtains control of the Company’s product, which occurs at a point in time, typically upon delivery to the distributor or customer.
−Removed: Payments from distributors are generally received 30 - 60 days from the date of sale.
+Added: In addition to distribution agreements with distributors, the Company enters into arrangements with health care providers and payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks and discounts with respect to the purchase of the Company’s product.
+Added: Revenues from product sales are recognized when the distributor obtains control of the Company’s product, which occurs at a point in time, typically upon delivery to the distributor.
+Added: Payments from distributors are generally received 45 day s from the date of sale.
The Company evaluates the creditworthiness of each of its distributors to determine whether revenues can be recognized upon delivery, subject to satisfaction of the other requirements, or whether recognition is required to be delayed until receipt of payment.
1 unchanged sentence
Reserves for Variable Consideration
−Removed: 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.
−Removed: 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).
−Removed: 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.
−Removed: Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the contract.
+Added: 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.
+Added: 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).
+Added: 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.
+Added: Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the contract.
The amount of variable consideration which is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period.
−Removed: Actual amounts of consideration ultimately received may differ from the Company’s estimates.
−Removed: 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.
+Added: Actual amounts of consideration ultimately received may differ from the Company’s estimates.
+Added: 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:
1 unchanged sentence
The payment terms for sales to distributors in the U.S.
−Removed: and Germany generally include a 2 - 3 % discount for prompt payment while the fees for distribution services are based on contractual rates agreed with the respective distributors.
+Added: and Europe generally include a 2 - 3 % discount for prompt payment while the fees for distribution services are based on contractual rates agreed with the respective distributors.
Based on historical data, the Company expects its distributors to earn these discounts and fees and deducts the full amount of these discounts and fees from its gross product revenues and accounts receivable at the time such revenues are recognized.
Rebates, Chargebacks and Discounts:
−Removed: 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.
+Added: 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 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.
2 unchanged sentences
For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program.
−Removed: The Company estimates the rebates, chargebacks and discounts that it will provide to Third-party Payors based upon (i) the Company’s contracts with these Third-party Payors, (ii) the government-mandated discounts applicable to government-funded programs, (iii) information obtained from the Company’s distributors and (iv) information obtained from other third parties regarding the payor mix for VASCEPA.
−Removed: The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period.
+Added: The Company estimates the rebates, chargebacks and discounts that it will provide to Third-party Payors based upon (i) the Company’s contracts with these Third-party Payors, (ii) the government-mandated discounts applicable to government-funded programs, (iii) information obtained from the Company’s distributors and (iv) information obtained from other third parties regarding the payor mix for VASCEPA.
+Added: The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been
+Added: recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period.
+Added: For the year ended December 31, 2023 , the Company recognized $ 15.1 million related to a change in estimate primarily for the Medicaid rebate provision as a result of a change in the percentage of business within the Medicaid segment, with a related reduction in net loss by $ 15.1 million in the year ended December 31, 2023.
+Added: Excluding this change in estimate, net loss per share basic and diluted for the year ended December 31, 2023 would have been $( 0.18 ).
Product Returns:
−Removed: The Company’s distributors have the right to return unopened unprescribed VASCEPA during the 18-month period beginning six months prior to the labeled expiration date and ending 12 months after the labeled expiration date.
+Added: The Company’s distributors have the right to return unopened unprescribed VASCEPA during the 18-month period beginning six months prior to the labeled expiration date and ending 12 months after the labeled expiration date.
The expiration date for VASCEPA 1-gram and 0.5-gram size capsules is currently four years and three years , respectively, after being converted into capsule form, which is the last step in the manufacturing process for VASCEPA and generally occurs within a few months before VASCEPA is delivered to distributors.
The Company estimates future product returns on sales of VASCEPA based on:
−Removed: (i) data provided to the Company by its distributors (including weekly reporting of distributors’
−Removed: sales and inventory held by distributors that provided the Company with visibility into the distribution channel in order to determine what quantities were sold to retail pharmacies and other providers), (ii) information provided to the Company from retail pharmacies, (iii) data provided to the Company by a third-party data provider which collects and publishes prescription data, and other third parties, (iv) historical industry information regarding return rates for similar pharmaceutical products, (v) the estimated remaining shelf life of VASCEPA previously shipped and currently being shipped to distributors and (vi) contractual agreements intended to limit the amount of inventory maintained by the Company’s distributors.
+Added: (i) data provided to the Company by its distributors (including weekly reporting of distributors’ sales and inventory held by distributors that provided the Company with visibility into the distribution channel in order to determine what quantities were sold to retail pharmacies and other providers), (ii) information provided to the Company from retail pharmacies, (iii) data provided to the Company by a third-party data provider which collects and publishes prescription data, and other third parties, (iv) historical industry information regarding return rates for similar pharmaceutical products, (v) the estimated remaining shelf life of VASCEPA previously shipped and currently being shipped to distributors and (vi) contractual agreements intended to limit the amount of inventory maintained by the Company’s distributors.
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.
1 unchanged sentence
Other incentives that the Company offers to indirect customers include co-pay mitigation rebates provided by the Company to commercially insured patients who have coverage for VASCEPA and who reside in states that permit co-pay mitigation programs.
−Removed: 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.
−Removed: 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.
+Added: 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.
+Added: 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.
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.
19 unchanged sentences
development, regulatory and commercial milestone payments;
−Removed: payments for manufacturing supply services the Company provides through its contract manufacturers;
+Added: payments for manufacturing supply services the Company provides through its
+Added: contract manufacturers;
and royalties on net sales of licensed products.
9 unchanged sentences
Licenses of intellectual property:
−Removed: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license.
+Added: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license.
For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees.
The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
+Added: During the three months ended June 30, 2023, the Company adjusted the measure of performance and recognized an additional $ 5.0 million and $ 5.3 million of license revenue relating to Eddingpharm (Asia) Macao Commercial Offshore Limited, or Edding, and HLS Therapeutics Inc., or HLS, respectively.
+Added: Excluding this change in estimate, net loss per share basic and diluted for the year ended December 31, 2023 would have been $( 0.17 ).
+Added: Refer to Note 8—Development, Commercialization and Supply Agreements for further details.
Milestone Payments:
7 unchanged sentences
The Company receives payments from its customers based on billing schedules established in each contract.
−Removed: Up-front payments and fees are recorded as deferred revenue upon receipt or when due, and may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements.
−Removed: Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional.
+Added: Upfront payments and fees are recorded as deferred revenue upon receipt or when due, and may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements.
+Added: Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional.
The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less.
1 unchanged sentence
Mochida Pharmaceutical Co., Ltd.
−Removed: 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.
−Removed: Among other terms in the agreement, the Company obtained an exclusive license to
−Removed: 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.
+Added: In June 2018, the Company entered into a collaboration with 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.
+Added: 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 U.S.
+Added: 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 U.S.
+Added: and certain other territories.
The potential new product and indication opportunities contemplated under this agreement are currently in early stages of development.
−Removed: Upon closing of the collaboration agreement, the Company made a non-refundable, non-creditable upfront payment of approximately $ 2.7 million.
+Added: Upon closing of the collaboration agreement, the Company made a non-refundable, non-creditable up-front payment of approximately $ 2.7 million.
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.
−Removed: 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.
+Added: In January 2023, 2022 and 2021, the Company exercised certain rights under the agreement, resulting in payments of $ 1.0 million, in each of such periods, to Mochida, which was recorded as research and development expense in the consolidated statement of operations.
Eddingpharm (Asia) Macao Commercial Offshore Limited
−Removed: In February 2015, the Company entered into a Development, Commercialization and Supply Agreement, or the DCS Agreement, with Eddingpharm (Asia) Macao Commercial Offshore Limited, or Edding, related to the development and commercialization of VASCEPA in Mainland China, Hong Kong, Macau and Taiwan, or the China Territory.
−Removed: Under the terms of the DCS Agreement, the Company granted to Edding an exclusive (including as to the Company) license with right to sublicense to develop and commercialize VASCEPA in the China Territory for uses that are currently commercialized and under development by the Company based on the Company’s MARINE, ANCHOR and REDUCE-IT clinical trials of VASCEPA.
+Added: In February 2015, the Company entered into a Development, Commercialization and Supply Agreement, or the DCS Agreement, with Edding related to the development and commercialization of VASCEPA in Mainland China, Hong Kong, Macau and Taiwan, or collectively, the China Territory.
+Added: Under the terms of the DCS Agreement, the Company granted to Edding an exclusive (including as to the Company) license with the right to sublicense development and commercialization of VASCEPA in the China Territory for uses that are currently commercialized and under development by the Company based on the Company’s MARINE, ANCHOR and REDUCE-IT clinical trials of VASCEPA.
Under the DCS Agreement, Edding is solely responsible for development and commercialization activities in the China Territory and associated expenses.
4 unchanged sentences
Development costs are paid by Edding to the extent such costs are incurred in connection with the negotiated development plan or otherwise incurred by Edding.
−Removed: Edding is responsible for preparing and filing regulatory applications in all countries of the China Territory at Edding’s cost with the Company’s assistance.
+Added: Edding is responsible for preparing and filing regulatory applications in all countries of the China Territory at Edding’s cost with the Company’s assistance.
The DCS Agreement also contains customary provisions regarding indemnification, supply, record keeping, audit rights, reporting obligations, and representations and warranties that are customary for an arrangement of this type.
1 unchanged sentence
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.
−Removed: 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’
−Removed: prior notice.
+Added: 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.
Neither party may assign or transfer the DCS Agreement without the prior consent of the other party, provided that the Company may assign the DCS Agreement in the event of a change of control transaction.
−Removed: Upon closing of the DCS Agreement, the Company received a non-refundable $ 15.0 million up-front payment.
+Added: Upon closing of the DCS Agreement, the Company received a non-refundable $ 15.0 million upfront payment.
In March 2016, Edding submitted its clinical trial application, or CTA, with respect to the MARINE indication for VASCEPA to the Chinese regulatory authority.
1 unchanged sentence
In March 2017, the CTA was approved by the Chinese regulatory authority, and, in December 2017, Edding commenced a pivotal clinical trial aimed to support the regulatory approval of the first indication of VASCEPA in a patient population with severe hypertriglyceridemia in Mainland China.
−Removed: 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.
−Removed: The Company received approval of VASCEPA under the REDUCE-IT indication in Hong Kong in February 2022.
−Removed: 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.
+Added: In November 2020, the Company announced statistically significant topline results from the Phase 3 clinical trial of VASCEPA conducted by Edding, which was used to seek regulatory approval in Mainland China.
+Added: The Company received approval of VASCEPA under the REDUCE-IT indication in Hong Kong in February 2022 and under the MARINE indication in Mainland China in the second quarter of 2023.
+Added: Following approval of VASCEPA in Mainland China under the MARINE indication, the Company received a non-refundable $ 5.0 million milestone payment.
+Added: In October 2023, Edding submitted its CTA with respect to the REDUCE-IT indication for VASCEPA to the Chinese regulatory authority.
+Added: Following the CTA submission, the Company recognized a non-refundable $ 3.0 million milestone.
+Added: In addition to the non-refundable, upfront and regulatory milestone payments described above, the Company is entitled to receive certain regulatory and sales-based milestone payments of up to an additional $ 145.0 million as well as tiered double-digit percentage royalties on net sales of VASCEPA in the China Territory escalating to the high teens.
The regulatory milestone events relate to the submission and approval of certain applications to the applicable regulatory authority, such as a clinical trial application, clinical trial exemption, or import drug license application.
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 $ 25.0 million.
−Removed: 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.
+Added: December 31, 2023 the Company has recognized $ 9.0 million relating to milestone achievements.
+Added: Achievement of regulatory approval for a third indication is not probable.
+Added: The achievement of 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.
4 unchanged sentences
Based on the analysis performed, the Company concluded that the identified performance obligations are not distinct and therefore a combined performance obligation.
−Removed: The transaction price includes the $ 15.0 million up-front consideration received and the $ 1.0 million milestone payment received related to the successful submission of the CTA for the MARINE indication.
−Removed: None of the other clinical or regulatory milestones have been included in the transaction price, as all milestone amounts are fully constrained.
−Removed: As part of its evaluation of the constraint, the Company considered numerous factors, including that receipt of the milestones is outside the control of the Company and contingent upon success in future clinical trials and the licensee’s efforts.
+Added: The transaction price includes the $ 15.0 million upfront consideration received, the $ 1.0 million milestone payment received related to the successful submission of the CTA for the MARINE indication, the $ 5.0 million milestone payment received related to the approval of VASCEPA under the MARINE indication and the $ 3.0 million milestone payment related to the submission of the CTA for the REDUCE-IT indication.
+Added: None of the other clinical or regulatory milestones has been included in the transaction price, as all milestone amounts are fully constrained.
+Added: As part of its evaluation of the constraint, the Company considered numerous factors, including that receipt of the milestones is outside the control of the Company and contingent upon success in future clinical trials and the licensee’s efforts.
Any consideration related to sales-based milestones including royalties, will be recognized when the related sales occur and therefore have also been excluded from the transaction price.
The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.
−Removed: 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.
−Removed: 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.
−Removed: 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 .
+Added: During the second quarter of 2023, Edding received regulatory approval in China under the MARINE indication and pursuit of additional indications outside of the REDUCE-IT indication is not probable.
+Added: As a result, the Company reevaluated the performance period and determined that completion of the remaining performance obligations was estimated to be by the end of December 2025.
+Added: The effect of this change in estimate from the previously received upfront payment and prior year milestone payments was an increase of $ 5.0 million in licensing revenue and a related reduction in net loss by $ 5.0 million for the year ended December 31, 2023 .
+Added: In addition, the Company recognized $ 3.9 million related to the milestone payment received in the second quarter for the MARINE indication approval and the remaining $ 1.1 million will be recognized over the remaining performance period through December 2025.
+Added: The change in estimate resulted in the remaining performance period decreasing from 11 years to three years for recognizing the remaining deferred revenue.
+Added: During the years ended December 31, 2023 and 2022, the Company recognized $ 12.9 million and $ 0.6 million, respectively, as licensing revenue related to the upfront and milestone payments received in connection with the Edding agreement.
+Added: From contract inception through December 31, 2023 and 2022, the Company recognized $ 20.6 million and $ 7.7 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.
+Added: The remaining transaction price of $ 4.4 million and $ 9.3 million is recorded in deferred revenue as of December 31, 2023 and 2022, respectively, on the consolidated balance sheets and as of December 31, 2023 will be recognized as revenue over the remaining period of two years .
The Company recognized net product revenue of $ 1.8 million and $ 0.2 million for the years ended December 31, 2023 and 2022, respectively, related to sales to Edding.
2 unchanged sentences
Under the terms of the distribution agreement, the Company granted to Biologix a non-exclusive license to use its trademarks in connection with the importation, distribution, promotion, marketing and sale of VASCEPA in the Middle East and North Africa territory.
−Removed: Upon closing of the agreement, the Company received a non-refundable up-front payment, which will be recognized as revenue over 10 years commencing upon first marketing approval of VASCEPA in the territory.
+Added: Upon closing of the agreement, the Company received a non-refundable upfront payment, which will be recognized as revenue over 10 years commencing upon first marketing approval of VASCEPA in the territory.
The Company is entitled to receive all payments based on total product sales and pays Biologix a service fee in exchange for its services, whereby the service fee represents a percentage of gross selling price which is subject to a minimum floor price.
4 unchanged sentences
December 2021
+Added: September 2023
+Added: September 2023
The Company recognized net product revenue of approximately $ 3.4 million and $ 1.0 million as of December 31, 2023 and 2022, respectively, related to sales to Biologix.
HLS Therapeutics, Inc.
−Removed: In September 2017, the Company entered into an agreement with HLS Therapeutics Inc., or HLS, a company incorporated under the laws of Canada, to register, commercialize and distribute VASCEPA in Canada.
−Removed: Under the agreement, HLS will be responsible for regulatory and commercialization activities and associated costs.
−Removed: The Company is responsible for providing assistance towards local
−Removed: filings, supplying finished product under negotiated supply terms, maintaining intellectual property, and continuing the development and funding of REDUCE-IT related activities.
−Removed: 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.
+Added: In September 2017, the Company entered into an agreement with HLS, a company incorporated under the laws of Canada, to register, commercialize and distribute VASCEPA in Canada.
+Added: Under the agreement, HLS is responsible for regulatory and commercialization activities and associated costs.
+Added: 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.
+Added: Upon closing of the agreement, the Company received one-half of a non-refundable $ 5.0 million upfront payment, and received the remaining half on the six-month anniversary of the closing.
Following achievement of the REDUCE-IT trial primary endpoint, which was announced in September 2018, the Company received a non-refundable $ 2.5 million milestone payment.
1 unchanged sentence
In addition, in January 2020, HLS obtained regulatory exclusivity from the Office of Patented Medicines and Liaison, or OPML, as a result the Company received a non-refundable $ 3.8 million milestone payment.
−Removed: In addition to the non-refundable, up-front and regulatory milestone payments just described, the Company is entitled to receive certain sales-based milestone payments of up to an additional $ 50.0 million, as well as tiered double-digit royalties on net sales of VASCEPA in Canada.
+Added: In addition to the non-refundable, upfront and regulatory milestone payments just described, the Company is entitled to receive certain sales-based milestone payments of up to an additional $ 50.0 million, as well as tiered double-digit royalties on net sales of VASCEPA in Canada.
The Company assessed this arrangement in accordance with Topic 606 and concluded that the contract counterparty, HLS, is a customer.
The Company identified the following performance obligations at the inception of the contract:
−Removed: (1) license to HLS to develop, register, and commercialize VASCEPA in Canada, (2) support general development and regulatory activities, and (3) participate in various steering committees.
+Added: (1) license to HLS to develop, register, and commercialize VASCEPA in Canada;
+Added: (2) support general development and regulatory activities;
+Added: and (3) participate in various steering committees.
Based on the analysis performed, the Company concluded that the identified performance obligations in the agreement are not distinct and therefore a combined performance obligation.
−Removed: The transaction price includes the $ 5.0 million up-front consideration, the $ 2.5 million milestone related to the achievement of the REDUCE-IT trial primary endpoint, the $ 2.5 million milestone related to obtaining approval from Health Canada and $ 3.8 million milestone related to obtaining regulatory exclusivity from the OPML.
+Added: The transaction price includes the $ 5.0 million upfront consideration, the $ 2.5 million milestone related to the achievement of the REDUCE-IT trial primary endpoint, the $ 2.5 million milestone related to obtaining approval from Health Canada and $ 3.8 million milestone related to obtaining regulatory exclusivity from the OPML.
Any consideration related to sales-based milestones (including royalties) will be recognized when the related sales occur and therefore have also been excluded from the transaction price.
The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.
−Removed: 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.
−Removed: 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.
−Removed: 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 .
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: The Company will be responsible for supplying finished product to CSL Seqirus at a profitable transfer price.
−Removed: The following table presents changes in the balances of the Company’s contract assets and liabilities for years ended December 31, 2022 and 2021:
+Added: During the second quarter of 2023, the Company concluded support for regulatory activities and pursuit of additional indications was deemed to be not probable.
+Added: As a result, the Company reevaluated the performance period and determined that all remaining performance obligations were satisfied as of June 30, 2023, resulting in a decrease of the previous performance period of eight years .
+Added: The effect of this change in estimate was the remaining transaction price of $ 5.3 million being recognized in licensing revenue and a related reduction in net loss by $ 5.3 million during the year ended December 31, 2023 from the previously received upfront payment and prior year milestone payments.
+Added: During the years ended December 31, 2023 and 2022, the Company recognized $ 5.6 million and $ 0.7 million, respectively, as licensing revenue related to upfront and milestone payments received in connection with the HLS agreement.
+Added: From the contract’s inception through December 31, 2023 and 2022, the Company has recognized $ 13.7 million and $ 8.2 million, respectively.
+Added: 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.
+Added: As of December 31, 2022 the remaining transaction price of $ 5.6 million is recorded in deferred revenue on the consolidated balance sheets.
+Added: The Company fully recognized the transaction price as of December 31, 2023.
+Added: The Company recognized net product revenue of $ 3.1 million and $ 2.9 million for the years ended December 31, 2023 and 2022, respectively, related to sales to HLS.
+Added: In February 2023, the Company entered into an agreement with CSL Seqirus, or CSL, to secure pricing and reimbursement, commercialize and distribute VAZKEPA in Australia and New Zealand.
+Added: The Company received an upfront payment of $ 0.5 million which was fully recognized during the first quarter of 2023.
+Added: In addition to the upfront payment, the Company will be eligible to receive event-related milestone payments of approximately $ 8.0 million and additional product-related milestone payments of approximately $ 4.0 million.
+Added: The Company will be responsible for supplying finished product to CSL Seqirus at a price that is the greater of (i) a fixed transfer price, or (ii) a fixed percentage of the net selling price, as defined in the CSL agreement.
+Added: The Company assessed this arrangement in accordance with Topic 606 and concluded that the contract counterparty, CSL, is a customer.
+Added: The Company identified the following distinct performance obligations at the inception of the contract:
+Added: an exclusive license to use its trademarks in connection with the importation, distribution, promotion, marketing and sale of VASCEPA in the Australia and New Zealand territories.
+Added: The transaction price includes the $ 0.5 million upfront consideration.
+Added: Any consideration related to event-based or product-based milestones will be recognized when the related milestone events occur and therefore have also been excluded from the transaction price.
+Added: The Company will reevaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.
+Added: During the year ended December 31, 2023 , the Company recognized $ 0.5 million as licensing revenue related to the upfront payment received in connection with the CSL agreement (none in 2022).
+Added: Lotus Pharmaceuticals
+Added: In July 2023, the Company entered into a distribution agreement with Lotus Pharmaceuticals, or Lotus, to commercialize and distribute VAZKEPA in South Korea and nine countries in Southeast Asia.
+Added: The Company received an up-front payment of $ 0.3 million and is eligible to receive event-related and product-related milestone payments.
+Added: The Company will be responsible for supplying finished product to Lotus at a pre-defined supply price.
+Added: The Company assessed this arrangement in accordance with Topic 606 and concluded that the contract counterparty, Lotus, is a customer.
+Added: The Company identified the following distinct performance obligations at the inception of the contract:
+Added: an exclusive license to use its trademarks in connection with the importation, distribution, promotion, marketing and sale of VASCEPA in the South Korea and Southeast Asian territories.
+Added: The transaction price includes the $ 0.3 million upfront consideration.
+Added: Any consideration related to event-based or product-based milestones will be recognized when the related milestone events occur and therefore have also been excluded from the transaction price.
+Added: The Company will reevaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.
+Added: During the year ended December 31, 2023 , the Company recognized $ 0.3 million as licensing revenue related to the upfront payment received in connection with the Lotus agreement (none in 2022).
+Added: The following table presents changes in the balances of the Company’s contract assets and liabilities for years ended December 31, 2023 and 2022:
End of Period
21 unchanged sentences
The Company has determined that the rate implicit in the lease is not determinable and the Company does not have borrowings with similar terms and collateral.
−Removed: Therefore, the Company considered a variety of factors, including the Company’s credit rating, observable debt yields from comparable companies with a similar credit profile and the volatility in the debt market for securities with similar terms, in determining that 11.5 % was reasonable to use as the incremental borrowing rate for purposes of the calculation of lease liabilities and a change of 1 % would not result in a material change to the Company’s consolidated financial statements.
+Added: Therefore, the Company considered a variety of factors, including the Company’s credit rating, observable debt yields from comparable companies with a similar credit profile and the volatility in the debt market for securities with similar terms, in determining that 11.5 % was reasonable to use as the incremental borrowing rate for purposes of the calculation of lease liabilities and a change of 1 % would not result in a material change to the Company’s consolidated financial statements.
On February 5, 2019, the Company entered into a lease agreement for new office space in Bridgewater, New Jersey, or the Lease.
4 unchanged sentences
On November 17, 2021, the Company entered into a lease agreement for new office space in Zug Switzerland, or the Zug Lease.
−Removed: The Zug Lease commenced on February 1, 2022 , or the Zug Commencement Date, for a 5-year period, with one five-year renewal option.
+Added: The Zug Lease commenced on February 1, 2022 , or the Zug Commencement Date, for a five-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.
−Removed: The Dublin Lease commenced on October 1, 2022 , or the Dublin Commencement Date, for a 2-year period.
+Added: The Dublin Lease commenced on October 1, 2022 , or the Dublin Commencement Date, for a two-year period.
Under the Dublin Lease, the Company will pay annual rent of approximately $ 0.4 million during the duration of the lease term.
−Removed: In addition to the real estate leases, the Company leases various vehicles with terms ranging from month to month up to 36 months .
+Added: In addition to the real estate leases, the Company continually enters into leases agreements for various vehicles with terms ranging from month to month up to 36 months .
The operating lease liability is $ 10.6 million and $ 11.6 million and the operating lease right-of-use asset is $ 8.3 million and $ 9.1 million, as of December 31, 2023 and 2022, respectively.
The lease expense for the years ended December 31, 2023, 2022 and 2021 is approximately $ 3.2 million, $ 2.8 million and $ 2.2 million, respectively.
−Removed: 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:
+Added: 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, 2023:
2029 and thereafter
3 unchanged sentences
Long-term operating lease liability
−Removed: The Company entered into a sublease agreement to lease a portion of the Bridgewater, New Jersey facility.
−Removed: The lease commenced on February 1, 2023 , or the Sublease Commencement Date, for a seven and a half year period .
−Removed: 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.
+Added: The Company classifies contractual lease arrangements entered as a lessor as a sales-type, direct financing or operating lease as described in ASC 842.
+Added: For sales-type leases, the Company derecognizes the leased asset and recognizes the lease investment on the balance sheet.
+Added: On January 20, 2023, the Company entered into a sublease agreement for 50,000 -square feet of the 67,747 -square foot New Jersey Lease and included within the sublease are furniture, fixtures and equipment, collectively the Sublease.
+Added: The Sublease commenced on February 1, 2023 , or the Sublease Commencement Date, for a 7.5 -year period.
+Added: Under the Sublease, the Company will be paid monthly rent of approximately $ 0.1 million for the first year following the Sublease Commencement Date, and such rent increases by a nominal percentage every year following the first anniversary of the Sublease Commencement Date.
+Added: In addition, Amarin will provide certain abatements subject to the limitations in the Lease.
+Added: The components of lease income are as follows:
+Added: For the Year Ended December 31,
+Added: Interest income from sales-type leases
+Added: Operating lease income
+Added: Loss recognized at commencement date of sales type lease
+Added: Future minimum sales type lease and operating lease receivables as of December 31, 2023 are as follows:
+Added: Sales-Type Leases
+Added: Operating Leases
+Added: 2029 and thereafter
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.