0000950170-23-005336 | 10-K | XBRL Viewer

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Document and Entity Information - USD ($) $ in Millions	12 Months Ended
Document and Entity Information - USD ($) $ in Millions	Dec. 31, 2022	Feb. 24, 2023	Jun. 30, 2022
Document And Entity Information [Line Items]
Document Type	10-K
Amendment Flag	false
Document Period End Date	Dec. 31, 2022
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	FY
Trading Symbol	AMRN
Entity Registrant Name	AMARIN CORP PLC\UK
Entity Central Index Key	0000897448
Current Fiscal Year End Date	--12-31
Entity Well-known Seasoned Issuer	Yes
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Voluntary Filers	No
Entity Filer Category	Large Accelerated Filer
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Small Business	false
Entity Public Float			$ 721.2
Entity File Number	0-21392
Entity Incorporation, State or Country Code	X0
Entity Address, Address Line One	Iconic Offices, The Greenway
Entity Tax Identification Number	00-0000000
Entity Address, Address Line Two	Block C Ardilaun Court
Entity Address, Address Line Three	112-114 St Stephens Green
Entity Address, City or Town	Dublin
Entity Address, Postal Zip Code	2
Entity Address, Country	IE
City Area Code	353 (0) 1
Local Phone Number	6699 020
Document Annual Report	true
Document Transition Report	false
Title of each class	American Depositary Shares (ADS(s)), each ADSrepresenting the right to receive one (1) Ordinary Share ofAmarin Corporation plc
Name of each exchange on which registered	NASDAQ
ICFR Auditor Attestation Flag	true
Documents Incorporated by Reference	DOCUMENTS INCORPORATED BY REFERENCE Certain information required to be disclosed in Part III of this Annual Report on Form 10-K is incorporated by reference from the registrant’s definitive proxy statement to be filed not later than 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K.
Auditor Firm ID	42
Auditor Name	Ernst & Young LLP
Auditor Location	Iselin, New Jersey
American Depositary Shares
Document And Entity Information [Line Items]
Entity Common Stock, Shares Outstanding		385,785,809
Ordinary Shares
Document And Entity Information [Line Items]
Entity Common Stock, Shares Outstanding		20,329,912

Consolidated Balance Sheets - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
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
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, GBP 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

Consolidated Balance Sheets (Parenthetical) - £ / shares	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Statement of Financial Position [Abstract]
Common stock, par value	£ 0.50	£ 0.50
Common stock, shares authorized, unlimited	Unlimited	Unlimited
Common stock, issued	412,333,087	404,084,775
Common stock, outstanding	404,346,256	396,598,008
Treasury stock, shares	7,986,831	7,486,767

Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
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
Product Revenue, Net
Total revenue, net	$ 366,511	$ 580,320	$ 607,025
Licensing and Royalty Revenue
Total revenue, net	$ 2,682	$ 2,867	$ 7,035

Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands	Total	Preferred Shares	Common Shares	Treasury Stock	Additional Paid-in Capital	Accumulated Deficit
Balance at Dec. 31, 2019	$ 608,263	$ 21,850	$ 269,173	$ (35,900)	$ 1,764,317	$ (1,411,177)
Balance (in shares) at Dec. 31, 2019		289,317,460	365,014,893
Balance, Treasury Shares (in shares) at Dec. 31, 2019				(4,910,992)
Conversion of Series A Convertible Preferred Stock, net	(504)	$ (21,850)	$ 18,020		3,326
Conversion of Series A Convertible Preferred Stock, net (in shares)		(289,317,460)	28,931,746
Issuance of common stock under employee stock purchase plan	1,957		$ 225		1,732
Issuance of common stock under employee stock purchase plan (in shares)			347,153
Exercise of stock options	5,158		$ 1,062		4,096
Exercise of stock options (in shares)			1,623,460
Vesting of restricted stock units	(15,182)		$ 1,635	$ (15,182)	(1,635)
Vesting of restricted stock units (in shares)			2,507,748	(975,927)
Stock-based compensation	45,813				45,813
Income (loss) for the period	(18,000)					(18,000)
Balance at Dec. 31, 2020	627,505		$ 290,115	$ (51,082)	1,817,649	(1,429,177)
Balance (in shares) at Dec. 31, 2020			398,425,000
Balance, Treasury Shares (in shares) at Dec. 31, 2020				(5,886,919)
Issuance of common stock under employee stock purchase plan	1,650		$ 275		1,375
Issuance of common stock under employee stock purchase plan (in shares)			399,286
Exercise of stock options	$ 2,921		$ 827		2,094
Exercise of stock options (in shares)	1,203,845		1,203,845
Vesting of restricted stock units	$ (9,644)		$ 2,810	$ (9,644)	(2,810)
Vesting of restricted stock units (in shares)			4,056,644	(1,599,848)
Stock-based compensation	36,938				36,938
Income (loss) for the period	7,729					7,729
Balance at Dec. 31, 2021	$ 667,099		$ 294,027	$ (60,726)	1,855,246	(1,421,448)
Balance (in shares) at Dec. 31, 2021			404,084,775
Balance, Treasury Shares (in shares) at Dec. 31, 2021	7,486,767			(7,486,767)
Issuance of common stock under employee stock purchase plan	$ 605		$ 283		322
Issuance of common stock under employee stock purchase plan (in shares)			456,696
Issuance of common stock for milestone payment	8,203		$ 3,461		4,742
Issuance of common stock for milestone payment (in shares)			5,817,942
Exercise of stock options	$ 60		$ 21		39
Exercise of stock options (in shares)	33,303		33,303
Vesting of restricted stock units	$ (1,044)		$ 1,210	$ (1,044)	(1,210)
Vesting of restricted stock units (in shares)			1,940,371	(500,064)
Stock-based compensation	26,213				26,213
Income (loss) for the period	(105,803)					(105,803)
Balance at Dec. 31, 2022	$ 595,333		$ 299,002	$ (61,770)	$ 1,885,352	$ (1,527,251)
Balance (in shares) at Dec. 31, 2022			412,333,087
Balance, Treasury Shares (in shares) at Dec. 31, 2022	7,986,831			(7,986,831)

Consolidated Statements of Cash Flows - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 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
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

Nature of Business and Basis of Presentation

12 Months Ended

Dec. 31, 2022

Accounting Policies [Abstract]

Nature of Business and Basis of Presentation

(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.

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.

Significant Accounting Policies

12 Months Ended

Dec. 31, 2022

Accounting Policies [Abstract]

Significant Accounting Policies

(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

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.

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.

(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

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:


	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.

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.

Intangible Asset

12 Months Ended

Dec. 31, 2022

Goodwill and Intangible Assets Disclosure [Abstract]

Intangible Asset

(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

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

Inventory

12 Months Ended

Dec. 31, 2022

Inventory Disclosure [Abstract]

Inventory

(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.

Property, Plant and Equipment

12 Months Ended

Dec. 31, 2022

Property, Plant and Equipment [Abstract]

Property, Plant and Equipment

(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.

Accrued Expenses and Other Current Liabilities

12 Months Ended

Dec. 31, 2022

Payables and Accruals [Abstract]

Accrued Expenses and Other Current Liabilities

(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