Item 9A. Controls and Procedures
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
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, 2022, our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide
86
only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our principal executive officer and principal financial officer have concluded based upon the evaluation described above that, as of December 31, 2022, our disclosure controls and procedures were effective at the reasonable assurance level.
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. Internal control over financial reporting is defined in Rules 13a-15(f) and 15(d)-15(f) under the Exchange Act as a process designed by, or under the supervision of, our principal executive officer and principal financial officer and effected by our board of directors, management, and other personnel 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 and includes those policies and procedures that:
• pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and disposition of our assets;
• provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles;
• provide reasonable assurance that our receipts and expenditures are being made only in accordance with authorization of our management and directors; and
• provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of our assets that could have a material effect on the financial statements.
Because of inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risks that controls may become inadequate because of changes in conditions or that the degree of compliance with the policies or procedures may deteriorate.
Our management, including our principal executive officer and principal financial officer, has conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2022. In conducting this evaluation, we used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission, or COSO, in Internal Control-Integrated Framework (2013) .
Based upon this evaluation and those criteria, management has concluded that, as of December 31, 2022, our internal control over financial reporting was effective.
Ernst & Young LLP (PCAOB ID 42 ), our independent registered public accounting firm, has audited our consolidated financial statements and the effectiveness of our internal control over financial reporting as of December 31, 2022. This report appears below.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting during the fourth quarter of 2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
87
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Shareholders and the Board of Directors of Amarin Corporation plc
Opinion on Internal Control over Financial Reporting
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). In our opinion, Amarin Corporation plc (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2022, based on the COSO criteria .
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’ 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.
Basis for Opinion
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. 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. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects.
Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control Over Financial Reporting
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. 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; 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. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
/s/ Ernst & Young LLP
Iselin, New Jersey
March 1, 2023
88
Item 9B. Othe r Information
Entry into Rule 10b5-1 Trading Plans
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. 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. Our policy also requires a waiting period after a trading plan is created before shares can be traded under the plan. Our open trading windows are established in consultation with legal counsel. 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.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not applicable.
89
PART III
Item 10. Directors, Executive Of ficers and Corporate Governance
The information required by this item will be contained in our definitive proxy statement, which will be filed with the SEC in connection with our 2023 Annual General Meeting of Shareholders. Such information is incorporated herein by reference.
Code of Ethics
Our board of directors has adopted a code of business conduct and ethical responsibility that applies to our directors, officers and employees. There have been no material modifications to, or waivers from, the provisions of such code. This code is available on the corporate governance section of our website (which is a subsection of the investor relations section of our website) at the following address: www.amarincorp.com. You may also request a printed copy of the code, without charge, by writing to us at Amarin Pharma, Inc., 440 Route 22, Bridgewater, NJ 08807, Attention: Investor Relations. In addition, should any changes be made to our code of business conduct and ethical responsibility, we intend to disclose within four business days on our website (or in any other medium required by law or the NASDAQ): (a) the date and nature of any amendment to our code of business conduct and ethical responsibility that applies to our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions and (b) the nature of any waiver, including an implicit waiver, from a provision of our code of business conduct and ethical responsibility that is granted to one of these specified officers, the name of such person is granted the waiver, and the date of the waiver.
Item 11. Executi ve Compensation
The information required by this item will be contained in our definitive proxy statement, which will be filed with the SEC in connection with our 2023 Annual General Meeting of Shareholders. Such information is incorporated herein by reference.
Item 12. Security Ownership of Certain Beneficial Ow ners and Management and Related Stockholder Matters
The information required by this item will be contained in our definitive proxy statement, which will be filed with the SEC in connection with our 2023 Annual General Meeting of Shareholders to be filed within 120 days after the fiscal year ended December 31, 2022 ("Definitive Proxy Statement"). Such information is incorporated herein by reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required by this item will be contained in our Definitive Proxy Statement, which will be filed with the SEC in connection with our 2023 Annual General Meeting of Shareholders. Such information is incorporated herein by reference.
Item 14. Principal Accoun tant Fees and Services
The information required by this item will be contained in our Definitive Proxy Statement, which will be filed with the SEC in connection with our 2023 Annual General Meeting of Shareholders. Such information is incorporated herein by reference.
90
PART IV
Item 15. Exhibits and Fina ncial Statement Schedules
(a)(1) For a list of the financial statements included herein, see Index to Consolidated Financial Statements on page F-1 of this Annual Report on Form 10-K.
(2) Financial statement schedules have been omitted because they are either not required or not applicable or the information is included in the consolidated financial statements or the notes thereto.
(3) Exhibits
The exhibits required by Item 601 of Regulation S-K and Item 15(b) of this Annual Report on Form 10-K are listed in the Exhibit Index below. The exhibits listed in the Exhibit Index are incorporated by reference herein.
(b) Exhibit Index
91
Exhibit
Incorporated by Reference Herein
Number
Description
Form
Date
3.1
Articles of Association of the Company
Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2013, as Exhibit 3.1
August 8, 2013
4.1
Form of Amended and Restated Deposit Agreement, dated as of November 4, 2011, among the Company, Citibank, N.A., as Depositary, and all holders from time to time of American Depositary Receipts issued thereunder
Annual Report on Form 10-K for the year ended December 31, 2011, as Exhibit 4.1
February 29, 2012
4.2
Form of Ordinary Share certificate
Annual Report on Form 20-F for the year ended December 31, 2002, as Exhibit 2.4
April 24, 2003
4.3
Form of American Depositary Receipt evidencing ADSs
Annual Report on Form 10-K for the year ended December 31, 2011, as Exhibit 4.4
February 29, 2012
4.4
Description of Registrant’s Securities
Annual Report on Form 10-K for the year ended December 31, 2019, as Exhibit 4.7
February 25, 2020
10.1
The Company 2002 Stock Option Plan*
Annual Report on Form 20-F for the year ended December 31, 2006, as Exhibit 4.17
March 5, 2007
10.2
The Company 2011 Stock Option Plan*
Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2011, as Exhibit 10.4
August 9, 2011
10.3
Amendment No. 1 to 2011 Stock Option Incentive Plan*
Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2012, as Exhibit 10.1
August 8, 2012
10.4
Amendment No. 2 to 2011 Stock Option Incentive Plan*
Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2012, as Exhibit 10.2
August 8, 2012
10.5
Amendment No. 3 to 2011 Stock Option and Incentive Plan*
Annual Report on Form 10-K for the year ended December 31, 2012, as Exhibit 10.5
February 28, 2013
10.6
Amendment No. 4 to 2011 Stock Option and Incentive Plan*
Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2015, as Exhibit 4.1
August 6, 2015
10.7
Amendment No. 5 to 2011 Stock Option and Incentive Plan*
Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2015, as Exhibit 4.2
August 6, 2015
10.8
Amendment No.6 to 2011 Stock Incentive Plan*
Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2017, as Exhibit 4.1
August 2, 2017
10.9
Amarin Corporation plc Management Incentive Compensation Plan*
Annual Report on Form 10-K for the year ended December 31, 2010, as Exhibit 10.44
March 16, 2011
10.10
Form of Incentive Stock Option Award Agreement *
Annual Report on Form 10-K for the year ended December 31, 2011, as Exhibit 10.3
February 29, 2012
10.11
Form of Non-Qualified Stock Option Award Agreement *
Annual Report on Form 10-K for the year ended December 31, 2011, as Exhibit 10.4
February 29, 2012
10.12
Form of Restricted Stock Unit Award Agreement *
Annual Report on Form 10-K for the year ended December 31, 2011, as Exhibit 10.5
February 29, 2012
10.13
2017 Employee Stock Purchase Plan*
Annual Report on Form 10-K for the year ended December 31, 2017, as Exhibit 10.64
February 27, 2018
10.14
2020 Stock Incentive Plan*
Current Report on Form 8-K dated July 13, 2020, as Exhibit 10.1
July 14, 2020
92
10.15
Amendment No. 1 to 2020 Stock Incentive Plan*
Current Report on Form 8-K dated June 27, 2022, as Exhibit 10.2
June 30, 2022
10.16
Form of Incentive Stock Option Award Agreement*
Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020, as Exhibit 10.2
November 5, 2020
10.17
Form of Non-Qualified Stock Option Award Agreements*
Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020, as Exhibit 10.3
November 5, 2020
10.18
Form of Restricted Stock Unit Award Agreement*
Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2022, as Exhibit 10.3
August 3, 2022
10.19
Form of Non-Qualified Stock Option for Non-Employee Director Award Agreement*
Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020, as Exhibit 10.5
November 5, 2020
10.20
Form of Deferred Restricted Stock Unit Award Agreement*
Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2022, as Exhibit 10.2
August 3, 2022
10.21
Amarin Corporation plc Executive Severance and Change of Control Plan*
Current Report on Form 8-K dated January 28, 2021, as Exhibit 10.1
January 29, 2021
10.22
Contract of Employment between Karim Mikhail and Amarin Switzerland GmbH, Grafenauweg 8, 6300 Zug, dated April 12, 2021*
Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2021, as Exhibit 10.4
April 29, 2021
10.23
Employment Agreement between Jason Marks and Amarin Corporation plc, dated July 19, 2021*
Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2021, as Exhibit 10.1
November 3, 2021
10.24
Letter Agreement with Steve Ketchum, dated February 8, 2012*
Registration Statement on Form F-1, as Exhibit 10.1
February 28, 2012
10.25
Amendment, dated July 6, 2015, to Letter Agreement with Steven Ketchum, dated February 8, 2012*
Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2015, as Exhibit 10.2
August 6, 2015
10.26
2012 Long Term Incentive Award with Steven Ketchum dated March 1, 2012*
Registration Statement on Form S-8, as Exhibit 4.2
March 16, 2012
10.27
Letter Agreement, dated May 9, 2016, by and between Amarin Corporation plc and Michael Kalb*
Current Report on Form 8-K dated June 30, 2016, as Exhibit 10.1
June 30, 2016
10.28
Employment Agreement, dated April 20, 2018, by and between Amarin Corporation plc and Aaron Berg*
Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2019, as Exhibit 10.1
May 1, 2019
10.29
Offer Letter with Thomas Reilly, dated May 26, 2022*
Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2022, as Exhibit 10.4
August 3, 2022
10.30
Transition and Separation Agreement between Michael W. Kalb and Amarin Corporation plc, dated June 6, 2022*
Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2022, as Exhibit 10.3
August 3, 2022
10.31
Transition Agreement between Jason M. Marks and Amarin Corporation plc, dated December 6, 2022*
Filed herewith
93
10.32
API Commercial Supply Agreement, dated May 25, 2011, between Amarin Pharmaceuticals Ireland Ltd. and Chemport Inc. **
Annual Report on Form 10-K for the year ended December 31, 2021, as Exhibit 10.35
March 1, 2022
10.33
Amendment to API Commercial Supply Agreement by and between Amarin Pharmaceuticals Ireland Ltd and Chemport Inc., dated April 4, 2012 **
Annual Report on Form 10-K for the year ended December 31, 2021, as Exhibit 10.36
March 1, 2022
10.34
Second Amendment to API Commercial Supply Agreement by and between Amarin Pharmaceuticals Ireland Ltd. and Chemport Inc., dated July 19, 2012 **
Annual Report on Form 10-K for the year ended December 31, 2021, as Exhibit 10.37
March 1, 2022
10.35
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 **
Annual Report on Form 10-K for the year ended December 31, 2021, as Exhibit 10.38
March 1, 2022
10.36
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
Annual Report on Form 10-K for the year ended December 31, 2017, as Exhibit 10.66
February 27, 2018
10.37
Co-Promotion Agreement dated March 31, 2014, by and among the Company and Kowa Pharmaceuticals America, Inc.
Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2014, as Exhibit 10.1
May 9, 2014
10.38
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.
Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2017, as Exhibit 10.1
August 2, 2017
10.39
Development, Commercialization and Supply Agreement dated February 26, 2015, by and between Amarin Pharmaceuticals Ireland Limited, Amarin Pharma, Inc. and Eddingpharm (Asia) Macao Commercial Offshore Limited
Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2015, as Exhibit 10.1
May 8, 2015
10.40
Distribution Agreement, dated March 8, 2016, by and among Biologix FZCo, Amarin Pharmaceuticals Ireland Limited and Amarin Pharma, Inc.
Annual Report on Form 10-K for the year ended December 31, 2017, as Exhibit 10.67
February 27, 2018
10.41
Development, Commercialization and Supply Agreement, dated September 25, 2017, by and among Amarin Pharmaceuticals Ireland Limited, Amarin Pharma, Inc. and HLS Therapeutics Inc.
Annual Report on Form 10-K for the year ended December 31, 2017, as Exhibit 10.68
February 27, 2018
10.42
Lease Agreement, dated February 5, 2019, by and between 440 Route 22 LLC and Amarin Pharma, Inc.
Annual Report on Form 10-K for the year ended December 31, 2018, as Exhibit 10.69
February 27, 2019
10.43
English Summary of German Language Commercial Lease Agreement dated October 10, 2021, by and between Amarin Switzerland GmbH and Zug Estates AG
Annual Report on Form 10-K for the year ended December 31, 2021, as Exhibit 10.54
March 1, 2022
94
10.44
Consent of Landlord to Sublease dated as of January 20, 2023, among Amarin Pharma, Inc. ST Shared Services LLC and Liberty Denver Wood LLC
Filed herewith
10.45
Guaranty dated January 20, 2023, issued by MEH, Inc.
Filed herewith
10.46
Sublease Agreement dated January 20, 2023, by and between Amarin Pharma, Inc. and ST Shared Services LLC
Filed herewith
10.47
License Agreement dated September 13, 2022, between Amarin Pharmaceuticals Ireland Ltd and Weston Office Solutions Ltd
Filed herewith
21.1
List of Subsidiaries
Filed herewith
23.1
Consent of Independent Registered Public Accounting Firm
Filed herewith
24.1
Power of Attorney
Included on the signature page(s) hereto
31.1
Certification of President and Chief Executive Officer (Principal Executive Officer) pursuant to Section 302 of Sarbanes-Oxley Act of 2002
Filed herewith
31.2
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
Filed herewith
32.1
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
Furnished herewith
101.INS
Inline XBRL Instance Document
Filed herewith
101.SCH
Inline XBRL Taxonomy Extension Schema Document
Filed herewith
101. CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document
Filed herewith
101. DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document
Filed herewith
101. LAB
Inline XBRL Taxonomy Extension Label Linkbase Document
Filed herewith
101. PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document
Filed herewith
104
Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibit 101.)
Filed herewith
Confidential treatment has been granted with respect to portions of this exhibit pursuant to an application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934. A complete copy of this exhibit, including the redacted terms, has been separately filed with the Securities and Exchange Commission.
** Certain confidential portions (indicated by brackets and asterisks) have been omitted from this exhibit.
* Management contract or compensatory plan or arrangement.
Item 16. Form 10-K Summary
Not applicable.
95
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
AMARIN CORPORATION PLC
By:
/s/ Karim Mikhail
Karim Mikhail
President and Chief Executive Officer
(Principal Executive Officer)
Date: March 1, 2023
We, the undersigned officers and directors of the Registrant hereby severally constitute and appoint Karim Mikhail and Tom Reilly, and each of them singly, our true and lawful attorneys, with full power to them and each of them singly, to sign for us in our names in the capacities indicated below, all amendments to this report, and generally to do all things in our names and on our behalf in such capacities to enable the Registrant to comply with the provisions of the Securities Exchange Act of 1934, as amended, and all requirements of the Securities and Exchange Commission.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the date indicated.
Signature
Title
Date
/s/ Karim Mikhail
Karim Mikhail
Director, President and Chief
Executive Officer (Principal
Executive Officer)
March 1, 2023
/s/ Tom Reilly
Tom Reilly
Senior Vice President and Chief
Financial Officer (Principal
Financial and Accounting Officer)
March 1, 2023
/s/ Adam Berger
Adam Berger
Director
March 1, 2023
/s/ Erin Enright
Erin Enright
Director
March 1, 2023
/s/ Jan van Heek
Jan van Heek
Director
March 1, 2023
/s/ Geraldine Murphy
Geraldine Murphy
Director
March 1, 2023
/s/ Kristine Peterson
Director
March 1, 2023
Kristine Peterson
/s/ Murray Stewart D.M., F.R.C.P.
Murray Stewart D.M., F.R.C.P.
Director
March 1, 2023
/s/ Alfonso Zulueta
Alfonso Zulueta
Director
March 1, 2023
96
AMARIN CORPORATION PLC
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page
Report of Independent Registered Public Accounting Firm
F- 2
Financial Statements:
Consolidated Balance Sheets as of December 31, 2022 and 2021
F- 4
Consolidated Statements of Operations for the years ended December 31, 2022, 2021 and 2020
F- 5
Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2022, 2021 and 2020
F- 6
Consolidated Statements of Cash Flows for the years ended December 31, 2022, 2021 and 2020
F- 7
Notes to Consolidated Financial Statements
F- 8
Financial Statement Schedules:
Financial statement schedules have been omitted for the reason that the required information is presented in the consolidated financial statements or notes thereto, the amounts involved are not significant or the schedules are not applicable.
F- 1
REPORT OF INDEPENDENT REGISTE RED PUBLIC ACCOUNTING FIRM
To the Shareholders and the Board of Directors of Amarin Corporation plc
Opinion on the Financial Statements
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’ 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”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2022 and 2021, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2022, in conformity with U.S. generally accepted accounting principles.
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.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. 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. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the account or disclosure to which it relates.
Product Return Reserve Estimate
Description of the Matter
At December 31, 2022, the Company recorded a liability for product returns totaling $8.7 million. As discussed in Note 13 of the financial statements, the Company sells its product to distributors that in turn resell the product to retail pharmacies for subsequent sale to patients and healthcare providers. The Company estimates variable consideration resulting from product returns based on quantitative and qualitative data from various internal and external sources.
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.
F- 2
How We Addressed the Matter in Our Audit
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. These procedures included controls over management’s review of the inputs used and assumptions applied in the returns reserve calculation and channel inventory analysis.
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. 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. 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. We read significant customer contracts and performed direct inquiries with management including the sales, legal, and contracting departments to identify any terms or conditions not included in customer contracts that could impact the estimate of product returns.
/s/ Ernst & Young LLP
We have served as the Company’s auditor since 2014.
Iselin, New Jersey
March 1, 2023
F- 3
AMARIN CORPORATION PLC
CONSOLIDATED BALANCE SHEETS
(in thousands, except share amounts)
December 31,
2022
2021
ASSETS
Current Assets:
Cash and cash equivalents
$
217,666
$
219,454
Restricted cash
523
3,918
Short-term investments
91,695
234,674
Accounts receivable, net
130,990
163,653
Inventory
228,732
234,676
Prepaid and other current assets
19,492
22,352
Total current assets
689,098
878,727
Property, plant and equipment, net
874
1,425
Long-term investments
1,275
34,996
Long-term inventory
163,620
121,254
Operating lease right-of-use asset
9,074
7,660
Other long-term assets
458
456
Intangible asset, net
21,780
23,547
TOTAL ASSETS
$
886,179
$
1,068,065
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable
$
64,602
$
114,922
Accrued expenses and other current liabilities
192,678
253,111
Current deferred revenue
2,199
2,649
Total current liabilities
259,479
370,682
Long-Term Liabilities:
Long-term deferred revenue
13,147
14,060
Long-term operating lease liability
10,015
8,576
Other long-term liabilities
8,205
7,648
Total liabilities
290,846
400,966
Commitments and contingencies (Note 7)
Stockholders’ Equity:
Common stock, £ 0.50 par, unlimited authorized; 412,333,087 shares issued, 404,346,256 shares outstanding at December 31, 2022; 404,084,775 shares issued, 396,598,008 shares outstanding at December 31, 2021
299,002
294,027
Additional paid-in capital
1,885,352
1,855,246
Treasury stock; 7,986,831 shares at December 31, 2022; 7,486,767 shares at December 31, 2021
( 61,770
)
( 60,726
)
Accumulated deficit
( 1,527,251
)
( 1,421,448
)
Total stockholders’ equity
595,333
667,099
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$
886,179
$
1,068,065
See the notes to the consolidated financial statements.
F- 4
AMARIN CORPORATION PLC
CONSOLIDATED STATEME NTS OF OPERATIONS
(in thousands, except per share amounts)
Year Ended December 31,
2022
2021
2020
Product revenue, net
$
366,511
$
580,320
$
607,025
Licensing and royalty revenue
2,682
2,867
7,035
Total revenue, net
369,193
583,187
614,060
Less: Cost of goods sold
108,631
121,327
131,444
Less: Cost of goods sold - restructuring inventory
18,078
—
—
Gross margin
242,484
461,860
482,616
Operating expenses:
Selling, general and administrative
304,416
408,334
463,312
Research and development
30,411
29,307
38,959
Restructuring
13,526
13,717
—
Total operating expenses
348,353
451,358
502,271
Operating (loss) income
( 105,869
)
10,502
( 19,655
)
Interest income
2,819
1,220
4,901
Interest expense
( 15
)
( 129
)
( 2,605
)
Other (expense) income, net
( 740
)
( 302
)
104
(Loss) income from operations before taxes
( 103,805
)
11,291
( 17,255
)
Provision for income taxes
( 1,998
)
( 3,562
)
( 745
)
Net (loss) income
$
( 105,803
)
$
7,729
$
( 18,000
)
(Loss) earnings per share:
Basic
$
( 0.26
)
$
0.02
$
( 0.05
)
Diluted
$
( 0.26
)
$
0.02
$
( 0.05
)
Weighted average shares outstanding:
Basic
401,155
395,992
381,759
Diluted
401,155
402,480
381,759
See the notes to the consolidated financial statements.
F- 5
AMARIN CORPORATION PLC
CONSOLIDATED STATEMENTS O F STOCKHOLDERS’ EQUITY
(in thousands, except share amounts)
Preferred
Shares
Common
Shares
Treasury
Shares
Preferred
Stock
Common
Stock
Additional
Paid-in
Capital
Treasury
Stock
Accumulated
Deficit
Total
December 31, 2019
289,317,460
365,014,893
( 4,910,992
)
$
21,850
$
269,173
$
1,764,317
$
( 35,900
)
$
( 1,411,177
)
$
608,263
Conversion of Series A
Convertible Preferred Stock, net
( 289,317,460
)
28,931,746
—
( 21,850
)
18,020
3,326
—
—
( 504
)
Issuance of common stock under
employee stock purchase plan
—
347,153
—
—
225
1,732
—
—
1,957
Exercise of stock options
—
1,623,460
—
—
1,062
4,096
—
—
5,158
Vesting of restricted stock units
—
2,507,748
( 975,927
)
—
1,635
( 1,635
)
( 15,182
)
—
( 15,182
)
Stock-based compensation
—
—
—
—
—
45,813
—
—
45,813
Loss for the period
—
—
—
—
—
—
—
( 18,000
)
( 18,000
)
December 31, 2020
—
398,425,000
( 5,886,919
)
$
—
$
290,115
$
1,817,649
$
( 51,082
)
$
( 1,429,177
)
$
627,505
Issuance of common stock under employee stock purchase plan
—
399,286
—
—
275
1,375
—
—
1,650
Exercise of stock options
—
1,203,845
—
—
827
2,094
—
—
2,921
Vesting of restricted stock units
—
4,056,644
( 1,599,848
)
—
2,810
( 2,810
)
( 9,644
)
—
( 9,644
)
Stock-based compensation
—
—
—
—
—
36,938
—
—
36,938
Income for the period
—
—
—
—
—
—
—
7,729
7,729
December 31, 2021
—
404,084,775
( 7,486,767
)
$
—
$
294,027
$
1,855,246
$
( 60,726
)
$
( 1,421,448
)
$
667,099
Issuance of common stock under employee stock purchase plan
—
456,696
—
—
283
322
—
—
605
Issuance of common stock for milestone payment
—
5,817,942
—
—
3,461
4,742
—
—
8,203
Exercise of stock options
—
33,303
—
—
21
39
—
—
60
Vesting of restricted stock units
—
1,940,371
( 500,064
)
—
1,210
( 1,210
)
( 1,044
)
—
( 1,044
)
Stock-based compensation
—
—
—
—
—
26,213
—
—
26,213
Loss for the period
—
—
—
—
—
—
—
( 105,803
)
( 105,803
)
December 31, 2022
—
412,333,087
( 7,986,831
)
$
-
$
299,002
$
1,885,352
$
( 61,770
)
$
( 1,527,251
)
$
595,333
See the notes to the consolidated financial statements.
F- 6
AMARIN CORPORATION PLC
CONSOLIDATED STATEME NTS OF CASH FLOWS
(in thousands)
Year Ended December 31,
2022
2021
2020
CASH FLOWS FROM OPERATING ACTIVITIES:
Net (loss) income
$
( 105,803
)
$
7,729
$
( 18,000
)
Adjustments to reconcile net (loss) income to net cash used in operating activities:
Depreciation and amortization
551
587
597
Amortization of investments
473
1,929
1,602
Stock-based compensation
26,213
36,938
45,813
Amortization of debt discount and debt issuance costs
—
—
635
Amortization of intangible asset
2,545
2,270
1,441
Changes in assets and liabilities:
Accounts receivable, net
32,663
( 9,079
)
( 38,144
)
Inventory
( 36,422
)
( 167,066
)
( 112,095
)
Prepaid and other current assets
2,860
8,595
( 17,636
)
Other long-term assets
( 2
)
( 24
)
642
Interest receivable
341
738
( 1,329
)
Accrued interest payable
—
—
( 428
)
Deferred revenue
( 1,363
)
( 1,923
)
( 2,214
)
Accounts payable, accrued expenses and other current liabilities
( 102,729
)
51,516
114,741
Other long-term liabilities
581
1,253
2,629
Net cash used in operating activities
( 180,092
)
( 66,537
)
( 21,746
)
CASH FLOWS FROM INVESTING ACTIVITIES:
Sale and maturities of securities
257,520
394,294
301,989
Purchases of securities
( 81,633
)
( 290,195
)
( 678,700
)
Investment in website development costs
( 599
)
—
—
Disposal (purchases) of furniture, fixtures and equipment
—
4
( 252
)
Net cash provided by (used in) investing activities
175,288
104,103
( 376,963
)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock under employee stock purchase plan
605
1,650
1,957
Proceeds from exercise of stock options, net of transaction costs
60
2,921
5,158
Payment of transaction costs for conversion of preferred stock
—
—
( 504
)
Payment on debt from royalty-bearing instrument
—
—
( 50,336
)
Taxes related to stock-based awards
( 1,044
)
( 9,644
)
( 15,182
)
Net cash used in financing activities
( 379
)
( 5,073
)
( 58,907
)
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH
( 5,183
)
32,493
( 457,616
)
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD
223,372
190,879
648,495
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH, END OF PERIOD
$
218,189
$
223,372
$
190,879
Supplemental disclosure of cash flow information:
Cash (paid) received during the year for:
Interest
$
—
$
—
$
( 2,043
)
Income taxes
$
( 1,782
)
$
3,656
$
( 207
)
Supplemental disclosure of non-cash transactions:
Laxdale milestone
$
—
$
12,000
$
—
Shares issued in settlement of Laxdale milestone payment
$
8,203
$
—
$
—
Initial recognition of operating lease right-of-use asset
$
2,041
$
—
$
—
Conversion of Series A Convertible Preferred Stock into common stock
$
—
$
—
$
18,020
See the notes to the consolidated financial statements.
F- 7
A MARIN C ORPORATION PLC
NOTES TO CONSOLIDA TED FINANCIAL STATEMENTS
(1) Nature of Business and Basis of Presentation
Nature of Business
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. 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. The Company has launched commercial operations in certain European countries, such as the United Kingdom, or the UK, and continues pre-launch commercial activities throughout the rest of Europe. The Company’s operations outside of the U.S. and Europe are in early stages of development with reliance on third-party commercial partners in select geographies.
The Company’s commercialized product, VASCEPA ® (icosapent ethyl), was approved by the U.S. Food and Drug Administration, or U.S. FDA, in July 2012 for use as an adjunct to diet to reduce triglyceride, or TG, levels in adult patients with severe ( > 500 mg/dL) hypertriglyceridemia, or the MARINE indication. VASCEPA was also approved for another indication in December 2019 for use as an adjunct to maximally tolerated statin therapy for reducing persistent cardiovascular risk in select high risk patients, or the REDUCE-IT indication.
In 2020, following our unsuccessful appeals of a court ruling in favor of two generic drug companies, Dr. Reddy's Laboratories, Inc., or Dr. Reddy's, and Hikma Pharmaceuticals USA Inc., or Hikma, and certain of their affiliates, or collectively, the Defendants, several of the Company's patents covering the MARINE indication were declared as invalid. As a result, the following generic versions of VASCEPA have obtained U.S. FDA approval with labeling consistent with the MARINE indication of VASCEPA and have entered the U.S. market with a 1-gram capsule:
Company
FDA MARINE Indication Approval
Launch Date
Hikma Pharmaceuticals USA Inc.
May 2020
November 2020
Dr. Reddy’s Laboratories, Inc.
August 2020
June 2021
Teva Pharmaceuticals USA, Inc.
September 2020
September 2022 (1)
Apotex, Inc.
June 2021
January 2022
(1) - Teva launched a 0.5-gram capsule in September 2022 and a 1-gram capsule in January 2023.
On March 26, 2021, the European Commission, or EC, approved the marketing authorization application for VAZKEPA, hereinafter along with the U.S. brand name VASCEPA, collectively referred to as VASCEPA, in the European Union, or EU, to reduce the risk of cardiovascular events in high-risk, statin-treated adult patients who have elevated triglycerides ( > 150 mg/dL) and either established cardiovascular disease or diabetes and at least one additional cardiovascular risk event. On April 22, 2021, the Company announced that the Medicines and Healthcare Products Regulatory Agency, or MHRA, approved VAZKEPA in England, Scotland and Wales to reduce cardiovascular risk through MHRA’s new ‘reliance’ route. On December 7, 2022, the Company announced that Swissmedic approved VAZKEPA in Switzerland. Collectively CHMP, EMA, EC and MHRA are referred to herein as the European Regulatory Authorities.
In November 2020, the Company announced topline results from the Phase 3 clinical trial of VASCEPA conducted by the Company’s partner in China. On February 9, 2021, the Company announced that regulatory review processes for approval of VASCEPA in Mainland China and Hong Kong had commenced. The Chinese National Medical Products Administration, or NMPA, has accepted for review the new drug application for VASCEPA based on the results from the Phase 3 clinical trial and the results from the Company’s prior studies of VASCEPA. On February 23, 2022, the Hong Kong Department of Health concluded their evaluation and approved the use of VASCEPA under the REDUCE-IT indication.
The Company currently has strategic collaborations to develop and commercialize VASCEPA in select territories outside the United States. Amarin is responsible for supplying VASCEPA to all markets in which the product is sold, including the United States, and certain countries throughout Europe, as well as, in Canada, Lebanon and the United Arab Emirates where the drug is promoted and sold via collaboration with third-party companies that compensate Amarin for such supply. Amarin is not responsible for providing any generic company with drug product. The Company operates in one business segment.
Basis of Presentation
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.
F- 8
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. 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. The results of operations for the years ended December 31, 2022, 2021 and 2020 are not necessarily indicative of the results for any future period. Certain numbers presented throughout this document may not add precisely to the totals provided due to rounding. Absolute and percentage changes are calculated using the underlying amounts in thousands. The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.
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.
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. 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. In addition, at December 31, 2022, the Company had Long-term investments of $ 1.3 million and Long-term inventory of $ 163.6 million. At December 31, 2022 , the Company had no debt outstanding.
(2) Significant Accounting Policies
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.
Use of Estimates
Accounting estimates are based on historical experience and other factors that are considered reasonable under the circumstances. Estimates and assumptions relied upon in preparing these consolidated financial statements relate to, but are not limited to, such items as provisions for sales returns, rebates and incentives, chargebacks, and other sales allowances; depreciable/amortizable lives; asset impairments; valuation allowance on deferred taxes; probabilities of achievement of performance conditions for certain equity awards; amounts recorded for licensing revenue; contingencies and accruals. Because of the uncertainties inherent in such estimates, actual results may differ from these estimates. Management periodically evaluates estimates used in the preparation of the consolidated financial statements for continued reasonableness.
Use of Forecasted Financial Information in Accounting Estimates
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. 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. Because of the inherent nature of forecasts, however, actual results may differ from these forecasts. Management regularly reviews the information related to these forecasts and adjusts the carrying amounts of the applicable assets prospectively, if and when actual results differ from previous estimates.
Revenue Recognition
In accordance with Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers , or Topic 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services committed within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the
F- 9
performance obligation is satisfied. For a complete discussion of accounting for net product revenue and licensing revenue, see Note 13—Revenue Recognition.
Distribution Costs
The Company records distribution costs related to shipping product to its customers, primarily through the use of common carriers or external distribution services, in Cost of goods sold.
Cash and Cash Equivalents and Restricted Cash
Cash and cash equivalents consist of cash, deposits with banks and short-term highly liquid money market instruments with original maturities at the date of purchase of 90 days or less. Restricted cash represents cash and cash equivalents pledged to guarantee repayment of certain expenses which may be incurred for business travel under corporate credit cards held by employees.
Accounts Receivable, net
Accounts receivable, net, comprised of trade receivables, are generally due within 45 days and are stated at amounts due from customers. The Company recognizes an allowance for losses on accounts receivable in an amount equal to the estimated probable losses net of any recoveries. The allowance is based primarily on assessment of specific identifiable customer accounts considered at risk or uncollectible, as well as an analysis of current receivables aging and expected future write-offs. The expense associated with the allowance for doubtful accounts is recognized as Selling, general, and administrative expense. The Company has not historically experienced any significant credit losses. All customer accounts are actively managed and no losses in excess of amounts reserved are currently expected; however, the Company is monitoring the potential negative impact of COVID-19 on the Company’s customers’ 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, 2022 and 2021:
In thousands
December 31, 2022
December 31, 2021
Gross trade accounts receivable
$
187,418
$
262,948
Trade allowances
( 44,626
)
( 86,636
)
Chargebacks
( 11,802
)
( 11,714
)
Allowance for doubtful accounts
—
( 945
)
Accounts receivable, net
$
130,990
$
163,653
Inventory
The Company states inventories at the lower of cost or net realizable value. Cost is determined based on actual cost using the average cost method. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. The Company classifies inventory as long-term inventory when consumption of the finished goods and work in process inventory is expected beyond the normal operating cycle. The Company classifies finished goods expected to be consumed within a normal operating cycle and all of VASCEPA's active pharmaceutical ingredient, or API, as current inventory. An allowance is established when management determines that certain inventories may not be saleable. If inventory cost exceeds expected net realizable value due to obsolescence, damage or quantities in excess of expected demand, changes in price levels or other causes, the Company will reduce the carrying value of such inventory to net realizable value and recognize the difference as a component of cost of goods sold in the period in which it occurs. The Company capitalizes inventory purchases of saleable product from approved suppliers while inventory purchases from suppliers prior to regulatory approval are included as a component of research and development expense. The Company expenses inventory identified for use as marketing samples when they are packaged. The average cost reflects the actual purchase price of VASCEPA API.
Long-Lived Asset Impairment
The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Recoverability of these assets is determined by comparing the forecasted undiscounted net cash flows of the operation to which the assets relate to their carrying amount. If impairment is indicated, the assets are written down to fair value. Fair value is determined based on discounted forecasted cash flows or appraised values, depending on the nature of the assets.
F- 10
Intangible Asset, net
Intangible asset, net consists of website development costs and milestone payments to the former shareholders of Laxdale Limited, or Laxdale, related to the 2004 acquisition of the rights to VASCEPA, which is the result of VASCEPA receiving marketing approval in the U.S. for the first indication in 2012, the expanded label in 2019 and marketing authorization in Europe in 2021. These assets are amortized over its estimated useful life on a straight-line basis. See Note 7—Commitments and Contingencies for further information regarding other obligations related to the acquisition of Laxdale.
Costs for Patent Litigation and Legal Proceedings
Costs for patent litigation or other legal proceedings are expensed as incurred and included in Selling, general and administrative expense.
Research and Development Costs
The Company charges research and development costs to operations as incurred. Research and development expenses are comprised of costs incurred by the Company in performing research and development activities, including: salary and benefits; stock-based compensation expense; laboratory supplies and other direct expenses; contractual services, including clinical trial and pharmaceutical development costs; commercial supply investment in its drug candidates; and infrastructure costs, including facilities costs and depreciation expense. 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. 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.
Income Taxes
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. Valuation allowances are provided against deferred tax assets that are not more likely than not to be realized. Deferred tax assets and liabilities are classified as non-current in the consolidated balance sheet.
The Company provides reserves for potential payments of tax to various tax authorities and does not recognize tax benefits related to uncertain tax positions and other issues. 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. 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. 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.
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. 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.
The Company’s and its subsidiaries’ income tax returns are periodically examined by various tax authorities, including the Internal Revenue Service, or IRS, and states. The Company is currently under audit by the IRS for the Company’s 2018 U.S. income tax return and by the New Jersey Department of Treasury for the years 2012 to 2015 . 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.
F- 11
(Loss) Earnings per Share
Basic net (loss) earnings per share is determined by dividing net (loss) income by the weighted average shares of common stock outstanding during the period. Diluted net (loss) earnings per share is determined by dividing net (loss) income by diluted weighted average shares outstanding. Diluted weighted average shares reflects the dilutive effect, if any, of potentially dilutive common shares, such as from the exercise of stock options and vesting of restricted stock units calculated using the treasury stock method. In periods with reported net operating losses, all stock options and restricted stock units outstanding are deemed anti-dilutive such that basic and diluted net loss per share are equal.
The calculation of net (loss) income and the number of shares used to compute basic and diluted net (loss) earnings per share for the years ended December 31, 2022, 2021, and 2020 are as follows:
In thousands
2022
2021
2020
Net (loss) income —basic and diluted
$
( 105,803
)
$
7,729
$
( 18,000
)
Weighted average shares outstanding—basic
401,155
395,992
381,759
Effect of dilutive securities:
Stock options
—
4,420
—
Restricted stock and restricted stock units
—
2,068
—
Weighted average shares outstanding—diluted
401,155
402,480
381,759
Net (loss) earnings per share—basic
$
( 0.26
)
$
0.02
$
( 0.05
)
Net (loss) earnings per share—diluted
$
( 0.26
)
$
0.02
$
( 0.05
)
For the years ended December 31, 2022, 2021 and 2020, the following potentially dilutive securities were not included in the computation of net (loss) earnings per share because the effect would be anti-dilutive or because performance criteria were not yet met for awards contingent upon such measures:
In thousands
2022
2021
2020
Stock options
19,182
9,926
16,664
Restricted stock and restricted stock units
14,461
3,764
7,710
Laxdale milestone shares
—
1,984
—
Stock options are anti-dilutive during periods of net earnings when the exercise price of the stock options exceeds the market price of the underlying shares on the last day of the reporting period. Restricted stock and restricted stock units are anti-dilutive during periods of net earnings when underlying performance-based vesting requirements were not achieved as of the last day of the reporting period.
Stock-Based Compensation
The Company accounts for stock-based compensation in accordance with the guidance of FASB ASC Topic 718, Compensation-Stock Compensation , or ASC 718, and requires the fair value of all stock-based payments to employees and non-employees to be recognized in the consolidated statement of operations over the requisite service period.
The fair value of the Company's restricted stock units is determined to be the market price on the date of the grant. The Company estimates the fair value of stock option awards on the date of the grant using the Black-Scholes Model, which requires that the Company makes certain assumptions regarding: (i) the expected volatility in the market price of its common stock; (ii) dividend yield; (iii) risk-free interest rates; and (iv) the period of time employees are expected to hold the award prior to exercise, referred to as the expected holding period. As a result, if the Company revises its assumptions and estimates, stock-based compensation expense could change materially for future grants.
For awards with performance conditions, if the achievement of the performance conditions is deemed probable, the Company recognizes compensation expense based on the grant date fair value of the award over the requisite service period. The Company reassesses the probability of achievement of the performance conditions each reporting period. The Company estimates the level of forfeitures expected to occur based on its historical data and records compensation cost only for those awards that are ultimately expected to vest. See Note 9—Stock Incentive Plans and Stock-Based Compensation for further discussion.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to credit risk consist primarily of cash and cash equivalents, short-term and long-term investments, and accounts receivable. 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.
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. Three customers individually accounted for 10% or more of the Company’s
F- 12
gross product sales. Customers A, B, and C accounted for 35 % , 31 % , and 27 % , respectively, of gross product sales for the year ended December 31, 2022 and represented 35 % , 21 % , and 39 % , respectively, of the gross accounts receivable balance as of December 31, 2022. Customers A, B, and C accounted for 37 % , 28 % and 27 % , respectively, of gross product sales for the year ended December 31, 2021 and represented 39 % , 22 % , and 35 % , respectively, of the gross accounts receivable balance as of December 31, 2021 . The Company has not experienced any significant write-offs of its accounts receivable. All customer accounts are actively managed and no losses are currently expected; however, the Company is monitoring the potential negative impact of COVID-19 on the Company’s customers’ ability to meet their financial obligations.
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. 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. 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.
The Company currently has manufacturing agreements with multiple independent API manufacturers and several independent API encapsulators and packagers for VASCEPA manufacturing. Each of these API manufacturers, encapsulators and packagers is U.S. FDA-approved and certain of these API manufacturers, encapsulators and packagers are also approved by the European Regulatory Authorities for manufacturing VAZKEPA in Europe. These suppliers are also used by the Company to source supply to meet the clinical trial and commercial demands of its partners in other countries. Each of these suppliers has qualified and validated its manufacturing processes. There can be no guarantee that these or other suppliers with which the Company may contract in the future to manufacture VASCEPA or VASCEPA API will remain qualified to do so to its specifications or that these and any future suppliers will have the manufacturing capacity to meet potential global demand for VASCEPA.
Foreign Currency
Monetary assets and liabilities denominated in a foreign currency are remeasured into U.S. dollars at period-end exchange rates. Gains and losses from the remeasurement are included in Other (expense) income, net in the consolidated statements of operations. For transactions settled during the applicable period, gains and losses are included in Other (expense) income, net in the consolidated statements of operations. Certain amounts payable pursuant to supply contracts are denominated in currencies other than the U.S. dollar. The Company recorded a foreign currency loss within the Other (expense) income, net on the consolidated statement of operations of $ 0.7 million, $ 0.6 million and less than $ 0.1 million for each of the years ended December 31, 2022, 2021, and 2020 , respectively.
Fair Value of Financial Instruments
The Company provides disclosure of financial assets and financial liabilities that are carried at fair value based on the price that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements may be classified based on the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities using the following three levels:
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.
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).
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.
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:
F- 13
December 31, 2022
In thousands
Total
Level 1
Level 2
Level 3
Asset:
Money Market Fund
$
81,870
$
81,870
$
—
$
—
U.S. Treasury Shares
3,117
3,117
—
—
Agency Securities
1,554
1,554
—
—
Corporate Bonds
28,416
—
28,416
—
Commercial Paper
62,347
—
62,347
—
Repo Securities
3,250
—
3,250
—
Asset Backed Securities
1,260
—
1,260
—
Certificate of Deposit
9,100
—
9,100
—
Non-US Government
1,393
—
1,393
—
Total
$
192,307
$
86,541
$
105,766
$
—
December 31, 2021
In thousands
Total
Level 1
Level 2
Level 3
Asset:
Money Market Fund
$
95,063
$
95,063
$
—
$
—
U.S. Treasury Shares
23,219
23,219
—
—
Corporate Bonds
83,587
—
83,587
—
Commercial Paper
121,773
—
121,773
—
Repo Securities
8,000
—
8,000
—
Asset Backed Securities
8,816
—
8,816
—
Certificate of Deposit
21,553
—
21,553
—
Non-US Government
12,900
—
12,900
—
Total
$
374,911
$
118,282
$
256,629
$
—
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.
The Company’s held-to-maturity 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 . Those with original maturities greater than 90 days and less than 12 months are included in short-term investments on its consolidated balance sheet. Those with remaining maturities in excess of 12 months are included in long-term investments on its consolidated balance sheet.
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. The Company evaluates securities with unrealized losses to determine whether such losses are other than temporary. The unrealized gain or loss for the year ended December 31, 2022 and December 31, 2021 were losses of $ 0.4 million and $ 0.2 million, respectively. Interest on investments is reported in interest income.
The carrying amounts of accounts payable and accrued liabilities approximate fair value because of their short-term nature.
Segment and Geographical Information
Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated on a regular basis by the chief operating decision-maker, or decision-making group, in deciding how to allocate resources to an individual segment and in assessing performance of the segment. The Company currently operates in one business segment, which is the development and commercialization of VASCEPA. 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
On September 22, 2021, the Company announced a Go-to-Market strategy for VASCEPA. As part of this strategy, the Company completed a reduction of its U.S. field force to approximately 300 sales representatives, enhanced managed care access and optimized VASCEPA prescriptions for cardiovascular risk reduction. During the year ended December 31, 2021, the Company recognized approximately $ 13.7 million in charges related to the reduction in force, substantially all of which were cash expenditures for one-time termination benefits and associated costs.
F- 14
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. business. As part of the plan, the Company completed a reduction of its U.S. field force from approximately 300 sales representatives to approximately 75 sales representatives. During the year ended December 31, 2022 the Company recognized approximately $ 9.4 million within Restructuring expense on the consolidated statement of operations related to the Comprehensive Cost Reduction Plan, substantially all of which are cash expenditures. The Company also reviewed its contractual supplier purchase obligations and has taken steps to amend supplier agreements to align supply arrangements with current and future market demand resulting in charges of $ 18.1 million recognized within Cost of goods sold - restructuring inventory for the year ended December 31, 2022 on the consolidated statement of operations. The Company continues to negotiate with other contract suppliers to align its supply arrangements with current and future global demand which may result in additional costs to the Company.
On August 19, 2022, the Company announced that after the conclusion of the fourth and final round of negotiations with the National Association of Statutory Health Insurance Funds, or GKV-SV, a viable agreement on the reimbursement price of VAZKEPA in Germany could not be reached. As a result of the negotiation outcome with the GKV-SV, the Company discontinued its German business operations effective September 1, 2022. The Company recognized approximately $ 4.2 million within Restructuring expense on the consolidated statement of operations, substantially all of which are cash expenditures.
The following table sets forth the components of the Company's restructuring charges for the years ended December 31, 2022 and 2021 (none in 2020):
For the Year Ended December 31,
In thousands
2022
2021
Employee restructuring separation charges
$
9,310
$
13,717
Vendor contract charges
4,216
—
Total restructuring expense
13,526
13,717
Restructuring inventory
18,078
—
Stock forfeitures
591
—
Total restructuring costs incurred
$
32,195
$
13,717
The following table shows the change in restructuring liability which is included within accrued expenses and other current liabilities:
In thousands
Restructuring Liability
Balance at December 31, 2021
$
1,186
Costs incurred
32,195
Payments
( 33,189
)
Balance at December 31, 2022
$
192
Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, and are early adopted by the Company or adopted as of the specified effective date.
The Company has evaluated all recently issued accounting pronouncements through the date of the financial statements and found that no recently issued accounting pronouncements, when adopted, will have a material impact on the Company’s condensed consolidated financial position, results of operations, and cash flows, or do not apply to the Company’s operations.
(3) Intangible Asset
Intangible asset consists of 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. For the year ended December 31, 2022 , the Company capitalized $ 0.8 million of costs associated with the development of a global company website. In accordance with ASC 350, the Company evaluates the remaining useful life of the intangible asset at each reporting period to determine if any events or circumstances warrant a revision to the remaining period of amortization. As of December 31, 2022, the intangible assets have an estimated weighted-average remaining useful life of 8.1 years. The carrying value as of December 31, 2022 and 2021 is as follows:
In thousands
December 31, 2022
December 31, 2021
Technology rights
$
32,859
$
32,081
Accumulated amortization
( 11,079
)
( 8,534
)
Intangible asset, net
$
21,780
$
23,547
F- 15
Amortization expense for the years ended December 31, 2022 and 2021 was $ 2.5 million and $ 2.3 million, respectively. Estimated future amortization expense, based upon the Company’s intangible asset, as of December 31, 2022 is as follows:
In thousands
Year Ending December 31,
Amount
2023
$
2,805
2024
2,805
2025
2,805
2026
2,546
2027
2,546
Thereafter
8,273
Total
$
21,780
(4) Inventory
The Company capitalizes its purchases of saleable inventory of VASCEPA from suppliers that have been qualified by the U.S. FDA and other global regulatory agencies. Inventories as of December 31, 2022 and 2021 consist of the following:
In thousands
December 31, 2022
December 31, 2021
Raw materials
$
126,391
$
107,695
Work in process
52,297
41,965
Finished goods
213,664
206,270
Inventory
$
392,352
$
355,930
The Company classifies inventory as long-term when consumption of the finished goods and work in process inventory are expected beyond the normal operating cycle. As of December 31, 2022 and 2021, we had $ 163.6 million and $ 121.3 million of Long-term inventory, respectively.
(5) Property, Plant and Equipment
Property, plant and equipment as of December 31, 2022 and 2021 consist of the following:
In thousands
Useful Life (in years)
December 31, 2022
December 31, 2021
Furniture and fixtures
5
$
1,633
$
1,633
Leasehold improvements
lesser of useful life or lease term
869
869
Software
3 - 5
617
617
Computer equipment
3 - 5
227
227
Property, plant and equipment
3,346
3,346
Accumulated depreciation and amortization
( 2,472
)
( 1,921
)
Property, plant and equipment, net
$
874
$
1,425
The Company provides for depreciation and amortization using the straight-line method by charges to operations in amounts that depreciate the cost of the fixed asset over its estimated useful life. Depreciation expense for the years ended December 31, 2022, 2021, and 2020 were $ 0.6 million, annually. Upon retirement or sale of assets, the cost of the assets disposed and the related accumulated depreciation are removed from the consolidated balance sheet and any resulting gain or loss is credited or expensed to operations. Repairs and maintenance costs are expensed as incurred.
F- 16
(6) Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consist of the following as of December 31, 2022 and 2021:
In thousands
December 31, 2022
December 31, 2021
Payroll and payroll-related expenses
$
20,302
$
19,730
Sales and marketing accruals
1,672
3,563
Accrued revenue allowances
135,061
184,216
All other
35,643
45,602
Accrued expenses and other current liabilities
$
192,678
$
253,111
(7) Commitments and Contingencies
Litigation – U.S. ANDAs
On March 30, 2020, the Nevada Court, ruled in favor of two generics companies, Hikma and Dr. Reddy’s, in Amarin’s patent litigation related to its ANDAs that sought U.S. 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. On September 3, 2020, the U.S. Court of Appeals for the Federal Circuit, or the Federal Circuit, upheld the March ruling by the Nevada Court in favor of the two generics companies. On October 2, 2020, the Company filed a combined petition for panel rehearing or rehearing en banc. On November 4, 2020, the Company’s rehearing and en banc petitions were denied. 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. 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. 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. On September 11, 2020, and June 30, 2021, Teva and Apotex, respectively, received U.S. FDA approval to market their respective generic versions of icosapent ethyl. In November 2020, Hikma announced the price and launched its generic version of icosapent ethyl. In June 2021, Dr. Reddy’s announced the price and launched its generic version of icosapent ethyl. In January 2022, Apotex announced the price and launched its generic version of icosapent ethyl. In September 2022, Teva announced the price and launched its generic version of icosapent ethyl for the 0.5-gram capsule and the 1.0 gram capsule in January 2023. All generic versions of icosapent ethyl as approved by the U.S. FDA pertains to the MARINE indication of VASCEPA, lowering of TG levels in patients with very high TG (>500 mg/dL). Current generic competition, together with past and on-going litigation related to such generic versions of icosapent ethyl are applicable to the U.S. only. The Company did not seek, nor is VAZKEPA approved in Europe for lowering of TG levels in patients with very high TG (>500 mg/dL).
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. 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. The complaint alleged that Hikma induced the infringement of VASCEPA-related CV risk reduction U.S. Patent Nos. 9,700,537 (Composition for preventing the occurrence of cardiovascular event in multiple risk patient), 8,642,077 (Stable pharmaceutical composition and methods of using same), and 10,568,861 (Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease) by making, selling, offering to sell and importing generic icosapent ethyl capsules in or into the United States.
In January 2021, the Company expanded the scope of the VASCEPA CV risk reduction patent infringement lawsuit against Hikma to include a health care insurance provider in the United States, Health Net LLC, or Health Net. Through insurance coverage and economic incentives the Company alleged that Health Net has actively induced pharmacies to dispense, and patients to use, Hikma generic icosapent ethyl capsules in infringement of the related patents. In the complaint, the Company sought remedies including a permanent injunction against the unlawful inducement by Hikma and Health Net of infringing uses of the Hikma generic product, i.e., uses to reduce cardiovascular risk as detailed in the patents, and monetary damages in an amount sufficient to compensate the Company for such infringement. On January 4, 2022, the district court hearing the case granted Hikma's motion to dismiss. On October 13, 2022, the district court granted final judgement on the aspect of the litigation relating to the Company and Hikma. The
F- 17
Company has appealed the decision of the district court. On December 26, 2022, the Company entered into a settlement agreement with Health Net that resolved the litigation relating to the Company and Health Net. The Company will continue to consider its legal options against parties similarly situated to Health Net and Hikma and acting in concert with either by making or selling any drug product or component thereof covered by the subject patents, or inducing others to do the same.
As has been a practice in the generic pharmaceutical industry, on April 27, 2021 and February 21, 2023, Dr. Reddy’s and Hikma, respectively, filed a complaint against the Company in the United States District Court for the District of New Jersey, Civil actions No.21-cv-10309 and No.3:23-cv-01016, alleging various antitrust violations stemming from alleged anticompetitive practices related to the supply of active pharmaceutical ingredient of VASCEPA. The complaints also includes a related state law tortious interference claim. Damages sought include recovery for alleged economic harm to Dr. Reddy’s and Hikma's, payors and consumers, treble damages and other costs and fees. Injunctive relief against the alleged violative activities is also being sought by Dr. Reddy’s and Hikma. Amarin believes it has valid defenses and will vigorously defend against the claims.
In March 2021, Amarin received a civil investigative demand, or CID, from the U.S. Federal Trade Commission and a subpoena from the New York Attorney General with respect to information on the same antitrust topic covered in the Dr. Reddy's litigation. Similarly, in June 2020, the Company received a CID from the U.S. Department of Justice, or the DOJ, informing Amarin that the DOJ is investigating whether aspects of its promotional speaker programs and copayment waiver program during the period from January 1, 2015 to the present violated the U.S. Anti-Kickback Statute and the U.S. 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. The Company believes such contact from the governments may have been prompted by a generic competitor. The inquiries require the Company to produce documents and answer written questions, or interrogatories, relevant to specified time periods. Amarin is cooperating with the government agencies and cannot predict when these investigations will be resolved, the outcome of the investigations or their potential impact on the Company’s business.
As has been a practice of class action legal counsel following governmental investigations and litigation by generics companies, Amarin is also named as a defendant in six antitrust class action lawsuits in the District Court for the District of New Jersey. Amarin is a defendant in a class action lawsuit filed by Uniformed Fire Officers Association Family Protection Plan Local 854 and the Uniformed Fire Officers Association for Retired Fire Officers Family Protection Plan, on behalf of indirect purchasers, in the District Court for the District of New Jersey, Civil Action No. 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. 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. 21-12416, alleging Amarin violated state and federal antitrust laws by monopolizing and engaging in a conspiracy to restrain trade in the icosapent ethyl drug and API markets. Amarin is a defendant in a class action lawsuit filed by 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. 21-13009. 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. 21-13406, alleging Amarin violated state and federal antitrust laws by monopolizing and engaging in a conspiracy to restrain trade in the icosapent ethyl drug and API markets. Amarin is a defendant in a class action lawsuit filed by Board of Trustees of Heavy and General Laborers' Local Unions 472 and 172 of N.J. Welfare Fund, on behalf of indirect purchasers, in the District Court of New Jersey, Civil Action No. 21-14639, alleging Amarin violated state and federal antitrust laws by monopolizing and engaging in a conspiracy to restrain trade in the icosapent ethyl drug and API markets. These cases have been consolidated into In re Vascepa Antitrust Litigation (Indirect Purchasers), Civil Action No. 21-12061, in the District Court for the District of New Jersey. Amarin is a defendant in a class action lawsuit filed by KPH Healthcare Services, Inc., on behalf of direct purchasers, in the District Court for the District of New Jersey, Civil Action No. 21-12747, alleging Amarin violated state and federal antitrust laws by monopolizing and engaging in a conspiracy to restrain trade in the icosapent ethyl drug and API markets. This case has been coordinated with the consolidated indirect purchaser case above as In re Vascepa Antitrust Litigation (Direct Purchasers), Civil Action No. 21-12747, in the District Court for the District of New Jersey.
Such antitrust litigation and investigations can be lengthy, costly and could materially affect and disrupt the Company’s business. 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.
Litigation – Other
On February 22, 2019, a purported investor in the Company’s publicly traded securities filed a putative class action lawsuit against Amarin Corporation plc, the former chief executive officer and chief scientific officer in the U.S. District Court for the District of New
F- 18
Jersey, Debendra Sharma v. Amarin Corporation plc, John F. Thero and Steven Ketchum, No. 2:19-cv-06601 (D.N.J. Feb. 22, 2019). On March 12, 2019, another purported investor filed a substantially similar lawsuit captioned Richard Borghesi v. Amarin Corporation plc, John F. Thero and Steven Ketchum, No. 3:19-cv-08423 (D.N.J. March 12, 2019). On May 14, 2019 the court consolidated the cases under the caption In re Amarin Corporation PLC Securities Litigation, No. 3:19-cv-06601 and appointed two other purported shareholders, Dan Kotecki and the Gaetano Cecchini Living Trust, as Co-Lead Plaintiffs. 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. 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. 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. The Amended Complaint further alleged that these purported misrepresentations and omissions inflated the share price. Based on these allegations, the suit asserted claims under the Securities Exchange Act of 1934 and sought unspecified monetary damages and attorneys’ fees and costs.
On March 29, 2021, the court granted the Company’s motion to dismiss this litigation for failure to state a valid claim. The litigation was dismissed without prejudice, giving the plaintiffs the right to file an amended complaint. Plaintiffs in this action did not file an amended complaint within the permitted filing deadline. Plaintiffs filed a notice of appeal of the motion to dismiss ruling, which has been denominated In re: Amarin Corp. PLC , case number 21-2071 (3d Cir.). On June 14, 2022, the Court of Appeals for the Third Circuit affirmed the dismissal of the matter by the trial district court.
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. District Court for the District of New Jersey, Vincent Dang v. Amarin Corporation plc, John F. Thero and Michael W. Kalb, No. 1:21-cv-19212 (D.N.J. Oct. 21, 2021) and a subsequent case, Dorfman v. Amarin Corporation plc, et al., No. 3:21-cv-19911 (D.N.J. filed Nov. 10, 2021), was filed in November 2021. In December 2021, several Amarin shareholders moved to consolidate the cases, or the Securities Litigation, and appoint a lead plaintiff and lead counsel pursuant to the Private Securities Litigation Reform Act. The plaintiffs filed an amended complaint on January 13, 2023 that added as a defendant the Company's former general counsel. The complaints in these actions are nearly identical and allege that the Company misled investors by allegedly downplaying the risk associated with the ANDA litigation described above and the risk that certain of the Company's patents would be invalidated. 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. 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.
On April 7, 2022, a purported investor in the Company's publicly traded securities filed a derivative lawsuit naming the same officer defendants from the Securities Litigation, the Officer Defendants, and also the members of the Company's board of directors, and the Company as nominal defendant in the U.S. District Court for the District of New Jersey, Gary Schader v. Amarin Corporation plc, John F. Thero, Michael W. Kalb, Lars G. Ekman, Jan Van Heek, Karim Mikhail, Patrick J. O'Sullivan, Per Wold-Olsen, Kristine Peterson, David Stack, and Joseph S. Zakrzewski, No. 3:22-cv-02017 (D.N.J. Apr. 7, 2022). The complaint alleges, like the Securities Litigation, that the defendants allegedly downplayed the risk associated with the ANDA litigation and the risk that certain of the Company's patents would be invalidated. Based on the allegations, plaintiffs allege that the directors breached their fiduciary duties and that the Officer Defendants were unjustly enriched, and plaintiffs seek contribution from the Officer Defendants for any liability they incur in the Securities Litigation and for which they are indemnified by the Company. On July 1, 2022, the plaintiff voluntarily dismissed this matter.
In addition to the above, in the ordinary course of business, the Company is from time to time involved in lawsuits, claims, investigations, proceedings, and threats of litigation relating to intellectual property, commercial arrangements and other matters.
Milestone and Supply Purchase Obligations
The Company currently has long-term supply agreements with multiple API suppliers and encapsulators. The Company is relying on these suppliers to meet current and potential future global demand for VASCEPA. Certain supply agreements require annual minimum volume commitments by the Company and certain volume shortfalls may require payments for such shortfalls.
These agreements include requirements for the suppliers to meet certain product specifications and qualify their materials and facilities with applicable regulatory authorities including the U.S. FDA. The Company has incurred certain costs associated with the qualification of product produced by these suppliers.
On June 6, 2022, the Company announced a Comprehensive Cost Reduction Plan which includes a comprehensive cost and organizational restructuring plan to address current shifts within the Company’s U.S. business as a result of the generic competition. As part of this plan, the Company has reviewed its contractual supplier purchase obligations and has entered into agreements with
F- 19
some suppliers to amend supplier agreements to align supply arrangements with current and future market demand. The Company continues to negotiate with other contract suppliers to align its supply arrangements with current and future global demand which may result in additional costs to the Company. As of December 31, 2022 , the Company has a total of approximately $ 86.0 million in future contractual purchase obligations without consideration to ongoing discussions with other suppliers.
On March 26, 2021, the EC approved the marketing authorization application for VAZKEPA. Under the 2004 share repurchase agreement with Laxdale upon receipt of pricing approval in Europe for the first indication for VASCEPA (or first indication of any product containing intellectual property acquired from Laxdale in 2004), the Company was obligated to make an aggregate stock or cash payment to the former shareholders of Laxdale (at the sole option of each of such former shareholders) of £ 7.5 million. On July 13, 2022 in connection with the United Kingdom's National Institute for Health and Care Excellence, or NICE's, final guidance for reimbursement of VAZKEPA and use across the National Health Service, or NHS, in England and Wales, representing receipt of marketing approval in Europe for the first indication for VAZKEPA, the Company became obligated to make the aggregate milestone payment of £ 7.5 million to Laxdale’s former shareholders (in either stock or cash at the election of each shareholder). A s of December 31, 2022, the Company has settled the first European indication approval milestone through issuance of stock and cash payments based on the respective shareholder's election.
Also under the Laxdale agreement, upon receipt of a marketing approval in Europe for a further indication of VASCEPA (or further indication of any other product acquired from Laxdale in 2004), the Company must make an aggregate stock or cash payment (at the sole option of each of such former shareholder) of £ 5.0 million (approximately $ 6.0 million as of December 31, 2022) for the potential market approval.
The Company has no provision for any of these obligations, except as noted above, since the amounts are either not paid or payable as of December 31, 2022 .
(8) Equity
Common Stock
On July 13, 2022, in connection with the United Kingdom's National Institute for Health and Care Excellence, or NICE's, final guidance for reimbursement of VAZKEPA and use across the National Health Service, or NHS, in England and Wales, representing receipt of marketing approval in Europe for the first indication for VAZKEPA, the Company became obligated to make an aggregate milestone payment of £ 7.5 million to Laxdale's former shareholders (in either stock or cash at the election of each shareholder) under the 2004 purchase agreement among the Company and such former shareholders. One of the shareholders elected to receive payment in stock for its pro rata portion of the milestone payment, resulting in the issuance of 5,817,942 shares at a price of $ 1.41 per share in July 2022.
During the years ended December 31, 2022 and 2021, other than as described elsewhere in this Annual Report on Form 10-K, including in the Notes to Consolidated Financial Statements, the Company did not engage in any transactions involving its common stock. Refer to Incentive Equity Awards below for discussion of ordinary shares issued as a result of stock option exercises and the vesting of restricted stock units. Refer to Note 9—Stock Incentive Plans and Stock Based Compensation for discussion of shares issued under the Company’s employee stock purchase plan.
Incentive Equity Awards
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. 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, 2022:
December 31, 2022
Outstanding stock options
19,182,111
% of outstanding shares on a fully diluted basis
4
%
Outstanding RSUs
14,461,050
% of outstanding shares on a fully diluted basis
3
%
F- 20
The following table represents equity awards activity during the years ended December 31, 2022 and 2021:
For the Year Ended December 31,
2022
2021
Common shares issued for stock option exercises
33,303
1,203,845
Gross and net proceeds from stock option exercises
$
59,686
$
2,921,000
Common shares issued in settlement of vested RSUs
1,940,371
1,203,845
Shares retained for settlement of employee tax obligations ─ RSUs
500,064
782,917
Common shares issued in settlement of vested Performance-Based RSUs (1)
—
1,923,316
Shares retained for settlement of employee tax obligations ─ Performance-Based RSUs
—
816,931
(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. These performance-based RSUs have fully vested as of August 2021.
During the years ended December 31, 2022 and 2021, the Company granted a total of 3,065,000 and 4,535,117 stock options, respectively, and 9,069,500 and 5,497,700 RSUs, respectively, to employees under the Plans. The RSUs typically vest annually over a three - or four-year period and the stock options typically vest quarterly over a four-year period. Also during 2022 and 2021, the Company granted a total of 1,919,500 and 2,008,800 RSUs, respectively, to employees under the Plans that vest upon the achievement of specified performance conditions.
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. 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. 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
On March 16, 2020, the Company’s Board of Directors, upon the recommendation of the Remuneration Committee, adopted, subject to shareholder approval, the 2020 Plan which was subsequently approved by the Company’s shareholders on July 13, 2020 at the Annual General Meeting of Shareholders. The 2020 Plan is the successor to the Company’s 2011 Plan, which was set to expire on July 12, 2021, and the Company’s 2002 Plan, the Plans.
The 2020 Plan allows the Company to grant stock options, both incentive and non-qualified options, to employees and Directors, restricted stock units to employees and unrestricted shares to Directors. The maximum number of the Company’s Ordinary Shares of £ 0.50 each or any ADS’s, as to be issued under the 2020 Plan shall not exceed the sum of (i) 20,000,000 shares and (ii) the number of Shares that remained available for grants under the Company’s 2011 Plan as of July 13, 2020. If any award granted and outstanding under the Plans expires or is forfeited, surrendered, canceled or otherwise terminated, the shares may be made available for subsequent grants under the 2020 Plan. The 2020 Plan is administered by the Remuneration Committee of the Company’s Board of Directors and expires on July 13, 2030.
Stock Options
Under the terms of the Plans, stock options typically vest over a four-year period and expire after a ten-year term. The stock options are granted at an exercise price equal to the closing price of the Company’s American Depositary Shares on the grant date. The following table summarizes all stock option activity for the year ended December 31, 2022:
F- 21
In thousands (except per share amounts and years)
Number of
Shares
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Term
Aggregate
Intrinsic
Value
Outstanding as of January 1, 2022
18,493
$
7.32
Granted
5,038
2.56
Forfeited
( 4,105
)
8.39
Expired
( 211
)
11.65
Exercised
( 33
)
1.79
Outstanding as of December 31, 2022
19,182
5.80
6.2 years
$
158
Exercisable as of December 31, 2022
12,888
6.80
4.9 years
$
86
Vested and expected to vest as of December 31, 2022
18,867
5.83
6.2 years
$
155
Available for future grant as of December 31, 2022
15,383
The weighted average grant date fair value of stock options granted during the years ended December 31, 2022, 2021, and 2020 was $ 2.56 , $ 5.12 , and $ 14.43 , respectively. The total grant date fair value of options vested during the years ended December 31, 2022, 2021, and 2020 was $ 16.6 million, $ 21.1 million, and $ 22.5 million, respectively.
During the years ended December 31, 2022, 2021 and 2020, the Company received proceeds from the exercise of options of $ 0.1 million, $ 2.9 million, and $ 5.2 million, respectively. The total intrinsic value of options exercised during the years ended December 31, 2022, 2021, and 2020 was nominal, $ 4.9 million, and $ 9.0 million, respectively, calculated as the difference between the quoted stock price of the Company’s common stock as of the reporting date and the exercise prices of the underlying awards.
As of December 31, 2022, options have $ 13.5 million of unrecognized stock-based compensation expense with such expense expected to be recognized over a weighted-average period of approximately 2.1 years.
The fair value of stock options on the date of grant was estimated using the Black-Scholes option pricing model. Use of a valuation model requires management to make certain assumptions with respect to selected model inputs, which include:
• Risk free rate : The risk-free interest rate is based on zero-coupon U.S. Treasury securities with a maturity term approximating the expected life of the option at the date of grant.
• Expected dividend yield : No dividend yield has been assumed as the Company does not currently pay dividends on its common stock and does not anticipate doing so in the foreseeable future.
• Expected option life: The expected life was determined using the simplified method based on the term and vesting period.
• Expected volatility: Expected stock price volatility was calculated based on the historical volatility of the Company’s common stock over the expected life of the option.
For 2022, 2021, and 2020, the Company used the following assumptions to estimate the fair value of share-based payment awards:
2022
2021
2020
Risk-free interest rate
1.64 % - 4.35 %
0.53 % - 1.36 %
0.33 % - 1.74 %
Expected dividend yield
0.00 %
0.00 %
0.00 %
Expected option life (years)
6.25
6.25
6.25
Expected volatility
96 % - 101 %
96 % - 99 %
84 % - 99 %
Employee stock options generally require future service and vest ratably over a four-year service period and are settled by the issuance of new common shares. The grant date fair value of the stock options, net of an estimated forfeiture rate is amortized straight-line over the awards’ vesting periods or respective requisite service periods and is adjusted for actual forfeitures over such period. The Company recorded compensation expense in relation to stock options of $ 14.8 million, $ 23.0 million, and $ 22.4 million for the years ended December 31, 2022, 2021, and 2020, respectively.
Restricted Stock Units
The restricted stock units vest based upon either a time-based service condition, a performance condition, or both. The grant date fair value of the restricted stock unites, net of the estimated forfeiture rate, is amortized straight-line over the vesting periods or requisite service periods and is adjusted for actual forfeitures over such period. For any awards with a performance condition, the probability that any performance criteria will be achieved is assessed by management and compensation expense for such awards is only recorded to the extent that the attainment of the performance criteria is deemed to be probable.
F- 22
The following table presents the restricted stock unit activity for the year ended December 31, 2022 :
In thousands (except per share amounts)
Shares
Weighted Average
Grant Date Fair
Value
Outstanding as of January 1, 2022
9,277
7.70
Granted
12,587
2.97
Vested
( 1,940
)
7.30
Forfeited
( 5,463
)
6.79
Outstanding as of December 31, 2022
14,461
$
3.98
The Company recorded compensation expense in relation to restricted stock units of $ 11.4 million, $ 13.9 million, and $ 23.4 million for the years ended December 31, 2022, 2021, and 2020 respectively. As of December 31, 2022, restricted stock units have $ 23.7 million of unrecognized stock-based compensation expense with such expense to be recognized over a weighted-average period of approximately 2.2 years.
The following table presents the stock-based compensation expense related to stock-based awards for the years ended December 31, 2022, 2021, and 2020:
In thousands
2022
2021
2020
Research and development
$
4,465
$
4,327
$
6,568
Selling, general and administrative
22,339
32,305
39,245
Restructuring
( 591
)
306
—
Stock-based compensation expense
$
26,213
$
36,938
$
45,813
Employee Stock Purchase Plan
On March 13, 2017, the Board adopted, subject to shareholder approval, the Amarin Corporation plc 2017 Employee Stock Purchase Plan, or the ESPP, which was approved by the Company’s shareholders on May 15, 2017. The ESPP is intended to qualify as an “employee stock purchase plan” within the meaning of Section 423 of the Internal Revenue Code. The maximum fair market value of stock which can be purchased by a participant in a calendar year is $ 25,000 .
Under the ESPP, an aggregate of 3,000,000 ordinary shares (each ordinary share to be represented by one ADS) are reserved and available for issuance, which were registered with the SEC on August 2, 2017, for sale to eligible employees. Subject to certain exclusions, any employee of the Company’s U.S. subsidiary, Amarin Pharma, Inc., who works at least 20 hours per week and has been employed for at least six months as of the first day of the applicable offering period is eligible to participate in the ESPP. Eligible employees may authorize payroll deductions of up to 15 percent of their base pay to be withheld to purchase ordinary shares, subject to terms and limitations of the plan, at a price equal to 85 percent of the lower of the fair market values of the Company’s ordinary shares as of the beginning or the end of six-month offering periods.
For the offering periods ended on the last business day on or before each of May 31, 2022 and November 30, 2022, the Company issued 265,214 shares and 191,482 shares, respectively, at a purchase price of $ 1.45 per share and $ 1.15 per share, respectively.
For the offering periods ended on the last business day on or before each of May 31, 2021 and November 30, 2021, the Company issued 226,402 shares and 172,884 shares, respectively, at a purchase price of $ 3.86 per share and $ 3.06 per share, respectively.
For the offering periods ended on the last business day on or before each of May 31, 2020 and November 30, 2020, the Company issued shares 123,608 shares and 223,545 shares, respectively, at a purchase price of $ 5.83 per share and $ 4.22 per share, respectively.
As of December 31, 2022, 1,361,577 shares were reserved for future issuance under the ESPP.
(10) Income Taxes
The Company recognizes interest and penalties related to uncertain tax positions within the provision for income taxes. The total amount of unrecognized tax benefits that would affect the Company’s effective tax rate if recognized is $ 8.2 million and $ 7.9 million as of December 31, 2022 and 2021, respectively. The Company recognized interest related to uncertain tax positions of $ 0.5 million and $ 0.9 million for the years ended December 31, 2022 and 2021 , respectively. No penalties have been recognized in conjunction with these positions.
F- 23
The following is a reconciliation of the total amounts of unrecognized tax benefits for the years ended December 31, 2022, 2021 and 2020:
In thousands
2022
2021
2020
Beginning uncertain tax benefits
$
22,040
$
24,034
$
26,743
Prior year—increases
—
16
2,428
Prior year—decreases
( 9,107
)
( 2,248
)
( 5,391
)
Current year—increases
5,782
238
254
Ending uncertain tax benefits
$
18,715
$
22,040
$
24,034
The Company files income tax returns in the United States, Ireland and United Kingdom, or UK. The Company remains subject to tax examinations in the following jurisdictions as of December 31, 2022:
Jurisdiction
Tax Years
United States—Federal
2018 - 2022
United States—State
2012 - 2022
Ireland
2018 - 2022
United Kingdom
2021 - 2022
The Company does no t expect any gross liabilities to expire in 2023 based on statutory lapses or audits.
The components of income (loss) from operations before taxes were as follows for the years ended December 31, 2022, 2021 and 2020:
In thousands
2022
2021
2020
United States
$
5,358
$
10,222
$
14,915
Ireland and United Kingdom
( 112,527
)
( 4,368
)
( 32,170
)
Other
3,364
5,437
—
Total (loss) / income before taxes
$
( 103,805
)
$
11,291
$
( 17,255
)
The provision for income taxes shown in the accompanying consolidated statements of operations consists of the following for the years ended December 31, 2022, 2021 and 2020:
In thousands
2022
2021
2020
Current:
United States—Federal
$
562
$
2,690
$
45
United States—State
573
716
700
Foreign
863
156
—
Total current
$
1,998
$
3,562
$
745
Deferred:
United States—Federal
( 3,721
)
5,222
1,972
United States—State
284
( 3,057
)
1,956
Foreign
( 1,646
)
( 1,619
)
( 26,793
)
Change in valuation allowance
5,083
( 546
)
22,865
Total deferred
$
—
$
—
$
—
Provision for income taxes
$
1,998
$
3,562
$
745
F- 24
The provision for income taxes differs from the amount computed by applying the statutory income tax rate to income before taxes due to the following for the years ended December 31, 2022, 2021 and 2020:
In thousands
2022
2021
2020
Benefits from taxes at statutory rate
$
( 25,952
)
$
2,823
$
( 4,314
)
Rate differential
9,141
( 4,416
)
128
Change in valuation reserves
5,083
( 546
)
22,865
Nondeductible employee compensation
2,344
5,249
6,122
Stock option/RSU windfall (shortfall)
3,569
81
( 3,262
)
ISO disqualifying disposition windfall
—
( 219
)
( 253
)
Research and development credits
( 958
)
( 1,170
)
( 6,225
)
Tax return to provision adjustments
424
( 8,372
)
( 138
)
Net operating loss carryback
—
—
( 2,465
)
Foreign exchange
7,859
4,109
( 10,852
)
Permanent and other
( 1,542
)
863
( 4,283
)
Uncertain tax positions
( 3,290
)
5,160
3,422
Foreign-derived intangible income
( 2,935
)
—
—
Loss of tax attributes
8,255
—
—
Provision for income taxes
$
1,998
$
3,562
$
745
The Company is subject to a corporate tax rate in Ireland of 25 % for non-trading activities and 12.5 % for trading activities. For the years ended December 31, 2022, 2021, and 2020 , the Company applied the statutory corporate tax rate of 25 % for Amarin Corporation plc, reflecting the non-trading tax rate in Ireland. However, for Amarin Pharmaceuticals Ireland Limited, a wholly-owned subsidiary of Amarin Corporation plc, the Company applied the 12.5 % Irish trading tax rate. In the table above, the Company used Amarin Corporat ion plc’s 25% tax rate as the starting point for the reconciliation since it is the parent entity of the business.
On August 16, 2022, the Inflation Reduction Act of 2022, or the Act, was signed into law by the Biden Administration, with tax provisions effective January 1, 2023 primarily focused on implementing a 15% minimum tax on global adjusted financial statement income (CAMT) and a 1% excise tax on share repurchases. While we are still evaluating the impact of the Act, we do not expect either of these provisions to have a material impact on our financial results.
On March 27, 2020, the Coronavirus Aid, Relief and Economic Security Act, or CARES Act, was enacted in the United States. 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. 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.
In April 2016, the Company adopted ASU No. 2016-09, Compensation-Stock Compensation (Topic 718): Improvements to Share-Based Payment Accounting which changes the accounting for certain aspects of share-based payments to employees. One aspect of the standard requires that excess tax benefits and deficiencies that arise upon vesting or exercise of share-based payments be recognized as an income tax benefit and expense in the income statement. Previously, such amounts were recognized as an increase and decrease in additional paid-in capital. 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.
F- 25
The income tax effect of each type of temporary difference comprising the net deferred tax asset as of December 31, 2022 and 2021 is as follows:
In thousands
December 31, 2022
December 31, 2021
Deferred tax assets:
Net operating losses
$
136,862
$
127,378
Stock-based compensation
11,616
8,563
Tax credits
2,639
15,803
Capitalized R&D
4,723
—
Lease liability
2,583
2,348
Other reserves and accrued liabilities
11,895
11,257
Gross deferred tax assets
170,318
165,349
Less: valuation allowance
( 165,378
)
( 160,295
)
Total deferred tax assets
4,940
5,054
Deferred tax liabilities:
Depreciation and amortization
( 3,337
)
( 3,404
)
Lease asset
( 1,603
)
( 1,639
)
Other liabilities
—
( 11
)
Total deferred tax liabilities
( 4,940
)
( 5,054
)
Net deferred tax assets
$
—
$
—
The Company assesses whether it is more-likely-than-not that the Company will realize its deferred tax assets. The Company determined that it was more-likely-than-not that the Irish, U.S., Germany, and Israeli net operating losses and the related deferred tax assets would not be realized in future periods and a full valuation allowance has been provided for all periods.
The following table reflects the activity in the valuation allowance for the years ended December 31, 2022 and 2021:
In thousands
2022
2021
Beginning valuation allowance
$
160,295
$
160,841
Increase as reflected in income tax expense
12,942
2,899
Foreign exchange
( 7,859
)
( 3,445
)
Ending valuation allowance
$
165,378
$
160,295
During 2022, 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. 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. and Non-U.S. net operating loss carryforwards of $ 834.4 million, which do not expire. The total net operating loss carryforwards decreased by approximately $ 15.6 million from the prior year primarily as a result of current year loss generated by the Company’s U.S. and Non-U.S. subsidiaries, the impact of foreign exchange rate changes, and adjustments to reconcile the financial statement accounts to the amounts reported on the filed 2021 foreign tax returns. In addition, the Company has U.S. Federal tax credit carryforwards of $ 9.5 million and state tax credit carryforwards of $ 3.7 million. These amounts exclude the impact of any unrecognized tax benefits and valuation allowances. These carryforwards, which will expire between 2023 and 2042 , may be used to offset future taxable income, if any.
As of December 31, 2022 , there are no earnings that have been retained indefinitely for reinvestment by foreign subsidiary; 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. The Company is currently under audit by the IRS for the Company’s 2018 U.S. 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. Although the outcome of tax audits is always uncertain and could result in significant cash tax payments, the Company does not believe the outcome of these audits will have a material adverse effect on the Company's consolidated financial position or results of operations.
(11) Defined Contribution Plan
The Company makes available a 401(k) plan for its U.S. employees. Under the 401(k) plan, employees may make contributions which are eligible for a discretionary percentage match, in cash, as defined in the 401(k) plan and determined by the Board of Directors. The
F- 26
Company recognized $ 1.7 million, $ 1.9 million and $ 1.7 million of related compensation expense for the years ended December 31, 2022, 2021 and 2020 , respectively.
(12) Co-Promotion Agreement
On March 31, 2014, the Company entered into a Co-Promotion Agreement, or the Agreement, with Kowa Pharmaceuticals America, Inc. related to the commercialization of VASCEPA capsules in the United States. The Company and Kowa Pharmaceuticals America, Inc. intentionally designed the Agreement to naturally end as of December 31, 2018 and mutually agreed not to renew the Agreement.
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. The accrued tail payments are paid over three years with declining amounts each year. Kowa Pharmaceuticals America, Inc. 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.
During the first quarter of 2022, the final co-promotion tail payment was made to Kowa Pharmaceuticals America, Inc. As of December 31, 2021, the Company recognized a net payable to Kowa Pharmaceuticals America, Inc. of $ 0.6 million was classified as current on the consolidated balance sheets, representing the remaining accrued co-promotion tail payments.
(13) Revenue Recognition
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. Patients are required to have a prescription in order to purchase VASCEPA. 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.
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. Payments from distributors are generally received 30 - 60 days 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. The Company calculates gross product revenues generally based on the wholesale acquisition cost or list price that the Company charges its distributors for VASCEPA.
Reserves for Variable Consideration
Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established and which result from (a) trade allowances, such as invoice discounts for prompt pay and distributor fees, (b) estimated government and private payor rebates and chargebacks and discounts, such as Medicaid reimbursements, (c) reserves for expected product returns and (d) estimated costs of incentives that are offered within contracts between the Company and its distributors, health care providers, payors and other indirect customers relating to the Company’s sales of its product. These reserves are based on individual contractual amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (distributor payments or credits) or as a current liability (payable to a non-distributor). Where appropriate, these estimates take into consideration a range of possible outcomes which are probability-weighted for relevant factors such as the Company’s historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. 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. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known.
Trade Allowances: The Company generally provides invoice discounts on VASCEPA sales to its distributors for prompt payment and fees for distribution services, such as fees for certain data that distributors provide to the Company. The payment terms for sales to distributors in the U.S. 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. 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.
F- 27
Rebates, Chargebacks and Discounts: The Company contracts with Medicaid, Medicare, other government agencies and various private organizations, or collectively, Third-party Payors, so that VASCEPA will be eligible for purchase by, for partial or full reimbursement from, such Third-party Payors. The Company estimates the rebates, chargebacks and discounts it will provide to Third-party Payors and deducts these estimated amounts from its gross product revenues at the time the revenues are recognized. The Company estimates these reserves based upon a range of possible outcomes that are probability-weighted for the estimated payor mix. These reserves are recorded in the same period the 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. 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. 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. 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.
Product Returns: 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: (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.
Other Incentives: 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. The Company’s co-pay mitigation program is intended to reduce each participating patient’s portion of the financial responsibility for VASCEPA’s purchase price to a specified dollar amount. Based upon the terms of the program and information regarding programs provided for similar specialty pharmaceutical products, the Company estimates the average co-pay mitigation amounts and the percentage of patients that it expects to participate in the program 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. The Company adjusts its accruals for co-pay mitigation rebates based on actual redemption activity and estimates regarding the portion of issued co-pay mitigation rebates that it estimates will be redeemed.
The following tables summarize activity in each of the net product revenue allowance and reserve categories described above for the years ended December 31, 2022 and 2021:
In thousands
Trade
Allowances
Rebates,
Chargebacks
and Discounts
Product
Returns
Other
Incentives
Total
Balance as of January 1, 2021
$
36,242
$
141,200
$
7,798
$
5,584
$
190,824
Provision related to current period sales
121,378
684,010
1,531
45,501
852,420
Provision related to prior period sales
—
( 2,034
)
—
—
( 2,034
)
Credits/payments made for current period sales
( 36,473
)
( 504,210
)
—
( 42,754
)
( 583,437
)
Credits/payments made for prior period sales
( 34,511
)
( 134,210
)
( 1,240
)
( 5,586
)
( 175,547
)
Balance as of December 31, 2021
86,636
184,756
8,089
2,745
282,226
Provision related to current period sales
96,340
676,816
2,347
26,612
802,115
Provision related to prior period sales
—
592
—
—
592
Credits/payments made for current period sales
( 54,952
)
( 548,783
)
—
( 24,671
)
( 628,406
)
Credits/payments made for prior period sales
( 83,398
)
( 177,288
)
( 1,690
)
( 2,630
)
( 265,006
)
Balance as of December 31, 2022
$
44,626
$
136,093
$
8,746
$
2,056
$
191,521
F- 28
Such net product revenue allowances and reserves are included within Accrued expenses and other current liabilities within the consolidated balance sheets, with the exception of trade allowances and chargebacks, which are included within Accounts receivable, net as discussed above.
Licensing Revenue
The Company enters into licensing agreements which are within the scope of Topic 606, under which it licenses certain rights to VASCEPA for uses that are currently commercialized and under development by the Company. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; payments for manufacturing supply services the Company provides through its contract manufacturers; and royalties on net sales of licensed products. Each of these payments results in licensing and royalty revenues.
In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation.
In determining performance obligations, management evaluates whether the license is distinct from the other performance obligations with the collaborative partner based on the consideration of the relevant facts and circumstances for each arrangement. Factors considered in the determination include the stage of development of the license delivered, research and development capabilities of the partner and the ability of partners to develop and commercialize VASCEPA independent of the Company.
Licenses of intellectual property: 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.
Milestone Payments: At the inception of each arrangement that includes development, regulatory and commercial milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The Company evaluates factors such as the scientific, clinical, regulatory, commercial and other risks that must be overcome to achieve the respective milestone as well as the level of effort and investment required. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development, regulatory and commercial milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect licensing revenues and earnings in the period of adjustment.
The Company receives payments from its customers based on billing schedules established in each contract. 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. 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.
(14) Development, Commercialization and Supply Agreements
In-licenses
Mochida Pharmaceutical Co., Ltd.
In June 2018, the Company entered into a collaboration with Mochida Pharmaceutical Co., Ltd., or Mochida, related to the development and commercialization of drug products and indications based on the active pharmaceutical ingredient in VASCEPA, the omega-3 acid, EPA, or eicosapentaenoic acid. Among other terms in the agreement, the Company obtained an exclusive license to
F- 29
certain Mochida intellectual property to advance the Company’s interests in the United States and certain other territories and the parties will collaborate to research and develop new products and indications based on EPA for the Company’s commercialization in the United States and certain other territories. The potential new product and indication opportunities contemplated under this agreement are currently in early stages of development.
Upon closing of the collaboration agreement, the Company made a non-refundable, non-creditable upfront 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.
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.
Out-licenses
Eddingpharm (Asia) Macao Commercial Offshore Limited
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. 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.
Under the DCS Agreement, Edding is solely responsible for development and commercialization activities in the China Territory and associated expenses. The Company provides development assistance and is responsible for supplying finished and later bulk drug product at defined prices under negotiated terms. The Company retains all VASCEPA manufacturing rights. Edding agreed to certain restrictions regarding the commercialization of competitive products globally and the Company agreed to certain restrictions regarding the commercialization of competitive products in the China Territory.
The Company and Edding agreed to form a joint development committee to oversee regulatory and development activities for VASCEPA in the China Territory in accordance with a negotiated development plan and formed a separate joint commercialization committee in advance of expected approval in the China Territory to oversee VASCEPA planning and pre-launch commercialization activities in the China Territory. 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. 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.
The term of the DCS Agreement expires, on a product-by-product basis, upon the later of (i) the date on which such product is no longer covered by a valid claim under a licensed patent in the China Territory, or (ii) the 12th anniversary of the first commercial sale of such product in Mainland China. The DCS Agreement may be terminated by either party in the event of a bankruptcy of the other party and for material breach, subject to customary cure periods. In addition, at any time following the third anniversary of the first commercial sale of a product in Mainland China, Edding has the right to terminate the DCS Agreement for convenience with 12 months’ 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.
Upon closing of the DCS Agreement, the Company received a non-refundable $ 15.0 million up-front 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. Following the CTA submission, the Company received a non-refundable $ 1.0 million milestone payment. 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. 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. The Company received approval of VASCEPA under the REDUCE-IT indication in Hong Kong in February 2022.
In addition to the non-refundable, up-front and regulatory milestone payments described above, the Company is entitled to receive certain regulatory and sales-based milestone payments of up to an additional $ 153.0 million as well as tiered double-digit percentage royalties on net sales of VASCEPA in the China Territory escalating to the high teens. 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 $ 33.0 million. The
F- 30
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. Each such milestone payment is non-refundable and non-creditable against any other milestone payments.
The Company assessed this arrangement in accordance with Topic 606 and concluded that the contract counterparty, Edding, is a customer. The Company identified the following performance obligations at the inception of the DCS Agreement: (1) the exclusive license to develop and commercialize VASCEPA in the China Territory for uses that are currently commercialized and under development by the Company, (2) the obligation to participate in various steering committees, and (3) ongoing development and regulatory assistance. Based on the analysis performed, the Company concluded that the identified performance obligations are not distinct and therefore a combined performance obligation.
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. None of the other clinical or regulatory milestones have been included in the transaction price, as all milestone amounts are fully constrained. 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.
During the years ended December 31, 2022 and 2021, the Company recognized $ 0.6 million and $ 1.1 million, respectively, as licensing revenue related to the up-front and milestone payments received in connection with the Edding agreement. From contract inception through December 31, 2022 and 2021, the Company recognized $ 7.7 million and $ 7.1 million, respectively, as licensing revenue under the DCS Agreement concurrent with the input measure of support hours provided by the Company to Edding in achieving the combined development and regulatory performance obligation, which in the Company’s judgment is the best measure of progress towards satisfying this performance obligation. The remaining transaction price of $ 9.3 million and $ 9.8 million is recorded in deferred revenue as of December 31, 2022 and 2021 , respectively, on the consolidated balance sheets and will be recognized as revenue over the remaining period of 12 years .
The Company recognized net product revenue of $ 0.2 million and $ 0.3 million for the years ended December 31, 2022 and 2021, respectively, related to sales to Edding.
Biologix FZCo
In March 2016, the Company entered into an agreement with Biologix FZCo, or Biologix, a company incorporated under the laws of the United Arab Emirates, to register and commercialize VASCEPA in several Middle Eastern and North African countries. 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. 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. 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.
The Company received approval of VASCEPA under the MARINE and REDUCE-IT indications in the following countries:
Country
MARINE
REDUCE-IT
Launch Date
Lebanon
March 2018
August 2021
June 2018
United Arab Emirates
July 2018
October 2021
February 2019
Qatar
December 2019
April 2021
—
Bahrain
April 2021
April 2022
—
Kuwait
December 2021
—
—
Saudi Arabia
March 2022
—
—
The Company recognized net product revenue of approximately $ 1.0 million and $ 1.4 million as of December 31, 2022 and 2021, respectively, related to sales to Biologix.
HLS Therapeutics, Inc.
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. Under the agreement, HLS will be responsible for regulatory and commercialization activities and associated costs. The Company is responsible for providing assistance towards local
F- 31
filings, supplying finished product under negotiated supply terms, maintaining intellectual property, and continuing the development and funding of REDUCE-IT related activities.
Upon closing of the agreement, the Company received one-half of a non-refundable $ 5.0 million up-front payment, and received the remaining half on the six-month anniversary of the closing. 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. Following approval from Health Canada in December 2019, the Company received a non-refundable milestone payment of $ 2.5 million in February 2020. 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. 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.
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: (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. 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.
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. 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.
During the years ended December 31, 2022 and 2021, the Company recognized $ 0.7 million and $ 0.9 million, respectively, as licensing revenue related to up-front and milestone payments received in connection with the HLS agreement. From the contract’s inception through December 31, 2022 and 2021, the Company has recognized $ 8.2 million and $ 7.5 million, respectively, as licensing revenue is recognized under the agreement concurrent with the input measure of support hours provided by the Company to HLS in achieving this performance obligation, which in the Company’s judgment is the best measure of progress towards satisfying the combined development and regulatory performance obligation. The remaining transaction price of $ 5.6 million and $ 6.2 million is recorded in deferred revenue as of December 31, 2022 and 2021 , respectively, on the consolidated balance sheets and will be recognized as revenue over the remaining period of 8 years .
The Company recognized net product revenue of $ 2.9 million and nil for the years ended December 31, 2022 and 2021, respectively, related to sales to HLS.
CSL Seqirus
In February 2023, the Company entered into an agreement with CSL Seqirus to secure pricing and reimbursement, commercialize and distribute VAZKEPA in Australia and New Zealand. The Company will receive an upfront payment of $ 0.5 million and be eligible to receive event-related milestone payments of approximately $ 8.0 million and additional product-related milestone payments of approximately $ 4.0 million. The Company will be responsible for supplying finished product to CSL Seqirus at a profitable transfer price.
The following table presents changes in the balances of the Company’s contract assets and liabilities for years ended December 31, 2022 and 2021:
In thousands
Balance at
Beginning of
Period
Additions
Deductions
Balance at
End of Period
Year ended December 31, 2022:
Contract assets
$
—
$
—
$
—
$
—
Contract liabilities:
Deferred revenue
$
16,709
$
6
$
( 1,369
)
$
15,346
Year ended December 31, 2021:
Contract assets
$
—
$
—
$
—
$
—
Contract liabilities:
Deferred revenue
$
18,632
$
128
$
( 2,051
)
$
16,709
F- 32
During the years ended December 31, 2022 and 2021, the Company recognized the following revenues as a result of changes in the contract asset and contract liability balances in the respective periods:
In thousands
Twelve Months Ended December 31,
Revenue recognized in the period from:
2022
2021
Amounts included in contract liability at the beginning of the period
$
1,366
$
1,997
Performance obligations satisfied in previous periods
$
2
$
46
(15) Leases
The Company leases office space under operating leases. The lease liability is initially measured at the present value of the lease payments to be made over the lease term. Lease payments are comprised of the fixed and variable payments to be made by the Company to the lessor during the lease term minus any incentives or rebates or abatements receivable by the Company from the lessor or the owner. Payments for non-lease components do not form part of lease payments. The lease term includes renewal options only if these options are specified in the lease agreement and if failure to exercise the renewal option imposes a significant economic penalty for the Company. As there are no significant economic penalties, renewal cannot be reasonably assured and the lease terms for the office space do not include any renewal options. The Company has not entered into any leases with related parties. The Company accounts for short-term leases (i.e., lease term of 12 months or less) by making the short-term lease policy election and will not apply the recognition and measurement requirements of ASC 842.
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. 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. The Lease commenced on August 15, 2019 , or the Commencement Date, for an 11 -year period, with two five-year renewal options. Subject to the terms of the Lease, Amarin will have a one-time option to terminate the agreement effective on the first day of the 97 th month after the Commencement Date upon advance written notice and a termination payment specified in the Lease. Under the Lease, the Company paid monthly rent of approximately $ 0.1 million for the first year following the Commencement Date, and such rent increases by a nominal percentage every year following the first anniversary of the Commencement Date. In addition, Amarin receives certain abatements subject to the limitations in the Lease.
On November 17, 2021, the Company entered into a lease agreement for new office space in Zug Switzerland, or the Zug Lease. The Zug Lease commenced on February 1, 2022 , or the Zug Commencement Date, for a 5-year period, with one five-year renewal option. Under the Zug Lease, the Company will pay annual rent of approximately $ 0.2 million for the first year following the Zug Commencement Date, and such rent increases by a nominal percentage every year following the first anniversary of the Zug Commencement Date.
On September 13, 2022, the Company entered into a lease agreement for new office space in Dublin, Ireland, or the Dublin Lease. The Dublin Lease commenced on October 1, 2022 , or the Dublin Commencement Date, for a 2-year period. Under the Dublin Lease, the Company will pay annual rent of approximately $ 0.4 million during the duration of the lease term.
In addition to the real estate leases, the Company leases various vehicles with terms ranging from month to month up to 36 months .
F- 33
The operating lease liability is $ 11.6 million and $ 10.3 million and the operating lease right-of-use asset is $ 9.1 million and $ 7.7 million, as of December 31, 2022 and 2021, respectively.
The lease expense for the years ended December 31, 2022, 2021 and 2020 is approximately $ 2.8 million, $ 2.2 million and $ 1.6 million, respectively.
The table below depicts a maturity analysis of the Company’s undiscounted payments for its operating lease liabilities and their reconciliation with the carrying amount of lease liability presented in the statement of financial position as of December 31, 2022:
Undiscounted
lease
payments
($000s)
2023
$
2,796
2024
2,572
2025
2,096
2026
2,131
2027
1,962
2028 and thereafter
5,251
Total undiscounted payments
$
16,808
Discount Adjustments
$
( 5,227
)
Current operating lease liability
1,566
Long-term operating lease liability
$
10,015
The Company entered into a sublease agreement to lease a portion of the Bridgewater, New Jersey facility. The lease commenced on February 1, 2023 , or the Sublease Commencement Date, for a seven and a half year period . Under the sublease, the Company will receive monthly rent payments of approximately $ 0.1 million during the first year, and such rent increases by a nominal percentage every year following the first anniversary of the Sublease Commencement Date.
F- 34
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.