AMARIN CORP PLC\UK [AMRN] Filings

10-Q 1 amrn-20240630.htm 10-Q 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2024

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File No. 000-21392

Amarin Corporation plc

(Exact Name of Registrant as Specified in its Charter)

    England and Wales

    Not applicable

    (State or Other Jurisdiction of
Incorporation or Organization)

    (I.R.S. Employer
Identification No.)

    Iconic Offices, The Greenway, Block C Ardilaun Court, 
112 – 114 St Stephens Green

    Dublin 2, Ireland

    (Address of Principal Executive Offices)

    (Zip Code)

Registrant’s telephone number, including area code: +353 (0) 1 6699 020

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol	Name of each exchange on which registered
American Depositary Shares (ADS(s)), each ADS representing the right to receive one (1) Ordinary Share of Amarin Corporation plc	AMRN	NASDAQ Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	☐	Accelerated filer	☒

Non-accelerated filer	☐	Smaller reporting company	☐

Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒

411,171,121 common shares were outstanding as of July 26, 2024, including 402,356,734 shares held as American Depositary Shares (ADSs), each representing one Ordinary Share, 50 pence par value per share, and 8,814,387 Ordinary Shares.

INDEX TO FORM 10-Q


		Page

	PART I – Financial Information

Item 1.	Financial Statements (unaudited):
	Condensed Consolidated Balance Sheets as of June 30, 2024 and December 31, 2023	3
	Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2024 and 2023	4
	Condensed Consolidated Statement of Changes in Stockholders’ Equity for the six months ended June 30, 2024 and 2023	5
	Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2024 and 2023	6
	Notes to Condensed Consolidated Financial Statements	7
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	25
Item 3.	Quantitative and Qualitative Disclosures about Market Risk	38
Item 4.	Controls and Procedures	38

	PART II – Other Information

Item 1.	Legal Proceedings	39
Item 1A.	Risk Factors	39
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	71
Item 5.	Other Information	71
Item 6.	Exhibits	72

SIGNATURES		73

PART I

AMARIN CORPORATION PLC

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited, in thousands, except share amounts)


	June 30, 2024			December 31, 2023
ASSETS
Current Assets:
Cash and cash equivalents	$	215,924		$	199,252
Restricted cash		525			525
Short-term investments		90,739			121,407
Accounts receivable, net		123,691			133,563
Inventory		239,408			258,616
Prepaid and other current assets		31,552			11,618
Total current assets		701,839			724,981
Property, plant and equipment, net		49			114
Long-term inventory		71,294			77,615
Operating lease right-of-use asset		7,540			8,310
Other long-term assets		1,287			1,360
Intangible asset, net		17,846			19,304
TOTAL ASSETS	$	799,855		$	831,684
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable	$	54,383		$	52,762
Accrued expenses and other current liabilities		176,159			204,174
Current deferred revenue		—			2,341
Total current liabilities		230,542			259,277
Long-Term Liabilities:
Long-term deferred revenue		—			2,509
Long-term operating lease liability		8,099			8,737
Other long-term liabilities		9,335			9,064
Total liabilities		247,976			279,587
Commitments and contingencies (Note 5)
Stockholders’ Equity:
Common stock, £0.50 par, unlimited authorized; 421,751,350 shares issued, 411,113,770 shares outstanding as of June 30, 2024; 418,141,295 shares issued, 408,824,093 shares outstanding as of December 31, 2023		305,046			302,756
Additional paid-in capital		1,906,903			1,899,456
Treasury stock; 10,637,580 shares as of June 30, 2024; 9,317,202 shares as of December 31, 2023		(65,276	)		(63,752	)
Accumulated deficit		(1,594,794	)		(1,586,363	)
Total stockholders’ equity		551,879			552,097
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	799,855		$	831,684

See notes to condensed consolidated financial statements.

AMARIN CORPORATION PLC

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited, in thousands, except per share amounts)


	Three months ended June 30,						Six months ended June 30,
	2024			2023			2024			2023
Product revenue, net	$	47,514		$	65,187		$	102,670		$	149,841
Licensing and royalty revenue		19,977			14,980			21,340			16,301
Total revenue, net		67,491			80,167			124,010			166,142
Less: Cost of goods sold		24,722			23,199			49,337			48,993
Less: Cost of goods sold - restructuring inventory		—			14,300			—			26,554
Gross margin		42,769			42,668			74,673			90,595
Operating expenses:
Selling, general and administrative		38,547			50,953			78,436			110,540
Research and development		4,746			5,642			10,344			11,323
Restructuring		—			10,032			—			10,032
Total operating expenses		43,293			66,627			88,780			131,895
Operating loss		(524	)		(23,959	)		(14,107	)		(41,300	)
Interest income, net		3,271			3,001			6,654			5,222
Other income, net		145			3,043			1,689			3,667
Income (loss) from operations before taxes		2,892			(17,915	)		(5,764	)		(32,411	)
(Provision for) benefit from income taxes		(1,370	)		355			(2,667	)		(1,609	)
Net income (loss)	$	1,522		$	(17,560	)	$	(8,431	)	$	(34,020	)
Earnings (loss) per share:
Basic	$	0.00		$	(0.04	)	$	(0.02	)	$	(0.08	)
Diluted	$	0.00		$	(0.04	)	$	(0.02	)	$	(0.08	)
Weighted average shares:
Basic		410,851			407,848			410,565			407,017
Diluted		411,395			407,848			410,565			407,017

See notes to condensed consolidated financial statements.

AMARIN CORPORATION PLC

CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY

(Unaudited, in thousands, except share amounts)


	Common Shares		Treasury Shares			Common Stock		Additional Paid-in Capital			Treasury Stock			Accumulated Deficit			Total
December 31, 2023		418,141,295		(9,317,202	)		302,756		1,899,456			(63,752	)		(1,586,363	)		552,097
Exercise of stock options		9,500		—			6		4			—			—			10
Vesting of restricted stock units		3,119,637		(1,217,450	)		1,980		(1,980	)		(1,436	)		—			(1,436	)
Stock-based compensation		—		—			—		5,218			—			—			5,218
Loss for the period		—		—			—		—			—			(9,953	)		(9,953	)
March 31, 2024		421,270,432		(10,534,652	)		304,742		1,902,698			(65,188	)		(1,596,316	)		545,936
Issuance of common stock under employee stock purchase plan		139,982		—			89		33			—			—			122
Vesting of restricted stock units		340,936		(102,928	)		215		(215	)		(88	)		—			(88	)
Stock-based compensation		—		—			—		4,387			—			—			4,387
Income for the period		—		—			—		—			—			1,522			1,522
June 30, 2024		421,751,350		(10,637,580	)		305,046		1,906,903			(65,276	)		(1,594,794	)		551,879


	Common Shares		Treasury Shares			Common Stock		Additional Paid-in Capital			Treasury Stock			Accumulated Deficit			Total
December 31, 2022		412,333,087		(7,986,831	)	$	299,002	$	1,885,352		$	(61,770	)	$	(1,527,251	)	$	595,333
Exercise of stock options		1,232,263		—			744		1,127			—			—			1,871
Vesting of restricted stock units		2,514,948		(827,523	)		1,539		(1,539	)		(1,507	)		—			(1,507	)
Stock-based compensation		—		—			—		5,556			—			—			5,556
Loss for the period		—		—			—		—			—			(16,460	)		(16,460	)
March 31, 2023		416,080,298		(8,814,354	)	$	301,285	$	1,890,496		$	(63,277	)	$	(1,543,711	)	$	584,793
Issuance of common stock under employee stock purchase plan		205,861		—			127		113			—			—			240
Exercise of stock options		6,000		—			4		3			—			—			7
Vesting of restricted stock units		800,242		(144,240	)		490		(490	)		(187	)		—			(187	)
Stock-based compensation		—		—			—		1,835			—			—			1,835
Loss for the period		—		—			—		—			—			(17,560	)		(17,560	)
June 30, 2023		417,092,401		(8,958,594	)	$	301,906	$	1,891,957		$	(63,464	)	$	(1,561,271	)	$	569,128

See notes to condensed consolidated financial statements.

AMARIN CORPORATION PLC

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited, in thousands)


	Six months ended June 30,
	2024			2023
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$	(8,431	)	$	(34,020	)
Adjustments to reconcile loss to net cash used in operating activities:
Depreciation and amortization		65			94
Accretion of investments		(2,745	)		(1,853	)
Stock-based compensation		9,605			7,391
Amortization of intangible asset		1,458			1,403
Changes in assets and liabilities:
Accounts receivable, net		9,872			8,260
Inventory		25,529			43,013
Prepaid and other current assets		(19,934	)		(23,814	)
Other long-term assets		73			(522	)
Interest receivable		(1	)		104
Deferred revenue		(4,850	)		(9,990	)
Accounts payable and other current liabilities		(26,394	)		11,627
Other long-term liabilities		403			(1,497	)
Net cash (used in) provided by operating activities		(15,350	)		196
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of furniture, fixtures and equipment		—			(23	)
Maturities of securities		133,000			96,993
Purchases of securities		(99,586	)		(82,260	)
Net cash provided by investing activities		33,414			14,710
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from the sale of common stock		122			240
Proceeds from exercise of stock options		10			1,878
Taxes paid related to stock-based awards		(1,524	)		(1,694	)
Net cash (used in) provided by financing activities		(1,392	)		424
NET INCREASE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH		16,672			15,330
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD		199,777			218,189
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH, END OF PERIOD	$	216,449		$	233,519
Supplemental disclosure of cash flow information:
Cash paid during the year for:
Income taxes	$	(669	)	$	(671	)
Supplemental disclosure of non-cash transactions:
Initial recognition of operating lease right-of-use asset	$	189		$	580
Initial recognition of furniture, fixtures and equipment lease	$	—		$	624

See notes to condensed consolidated financial statements.

AMARIN CORPORATION PLC

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

For purposes of this Quarterly Report on Form 10-Q, ordinary shares may also be referred to as “common shares” or “common stock.”

(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. The Company is commercialized in the United States, or the U.S., under the brand name VASCEPA® (icosapent ethyl), or VASCEPA. The Company is also commercialized in certain European countries, such as the United Kingdom, or the UK, and Spain under the brand name VAZKEPA, hereinafter along with VASCEPA, collectively referred to as VASCEPA. The Company’s operations outside of the U.S. and Europe are in varying stages of development and commercialization with reliance on third-party commercial partners in select geographies, including China and Canada.

VASCEPA was first approved by the U.S. Food and Drug Administration, or U.S. FDA, in July 2012 for use as an adjunct to diet to reduce triglyceride, or TG, levels in adult patients with severe (>500 mg/dL) hypertriglyceridemia, or the MARINE indication. In January 2013, the Company launched 1-gram size VASCEPA in the U.S. and in October 2016, introduced a 0.5-gram capsule size. On December 13, 2019, the U.S. FDA approved another indication and label expansion for VASCEPA based on the results of the Company’s long-term cardiovascular outcomes trial, REDUCE-IT®, or Reduction of Cardiovascular Events with EPA – Intervention Trial. VASCEPA is approved by the U.S. FDA as an adjunct to maximally tolerated statin therapy for reducing persistent cardiovascular risk in select high risk patients, or the REDUCE-IT indication.

On March 30, 2020, following conclusion of a trial in late January 2020, the U.S. District Court for the District of Nevada, or the Nevada Court, issued a ruling in favor of two generic drug companies, Dr. Reddy’s Laboratories, Inc., or Dr. Reddy’s, and Hikma Pharmaceuticals USA Inc., or Hikma, and certain of their affiliates, or, collectively, the Defendants, that declared as invalid several of the Company's patents covering the MARINE indication. The Company sought appeals of the Nevada Court judgment up to the United States Supreme Court, but the Company was unsuccessful. As a result, the following generic versions of VASCEPA have obtained U.S. FDA approval with labeling consistent with the MARINE indication of VASCEPA and have entered the U.S. market:


Company	FDA MARINE Indication Approval	1-gram Launch Date	0.5-gram Launch Date
Hikma Pharmaceuticals USA Inc.	May 2020	November 2020	March 2023
Dr. Reddy’s Laboratories, Inc.	August 2020	June 2021	June 2023
Teva Pharmaceuticals USA, Inc.	September 2020	January 2023	September 2022
Apotex, Inc.	June 2021	January 2022	N/A
Zydus Lifesciences	April 2023	N/A	June 2024
Strides Pharma 1	September 2023	April 2024	April 2024
Epic Pharma	December 2023	March 2024	N/A
Ascent Pharmaceuticals, Inc. 2	December 2023	April 2024	April 2024

(1) Strides Pharma licensed its rights to the generic version of VASCEPA to Amneal Pharmaceuticals.

(2) Ascent Pharmaceuticals, Inc. licensed its rights to the generic version of VASCEPA to Camber Pharmaceuticals, Inc.

On March 26, 2021, the European Commission, or EC, approved the marketing authorization application for VAZKEPA, 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. 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 June 1, 2023, the Company announced the National Medical Products Administration, or NMPA, granted approval for VASCEPA under the MARINE indication and the Company's partner launched commercially in October 2023. On June 28, 2024 the Company's partner in China received NMPA approval for VASCEPA in Mainland China for the REDUCE-IT indication. On February 23, 2022, the Hong Kong Department of Health approved the use of VASCEPA under the REDUCE-IT indication.

Amarin is responsible for supplying VASCEPA to all markets in which the product is sold, including the United States and Europe, as well as in countries where the drug is promoted and sold via collaboration with third-party companies that compensate Amarin for such supply. Amarin is not responsible for providing any generic company with drug product. The Company operates in one business segment.

Basis of Presentation

The condensed consolidated financial statements included herein have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles, or GAAP, and pursuant to the rules and regulations of the Securities and Exchange Commission, or the SEC. Certain information in the footnote disclosures of the financial statements has been condensed or omitted where it substantially duplicates information provided in the Company’s latest audited consolidated financial statements, in accordance with the rules and regulations of the SEC. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and notes included in its Annual Report on Form 10-K for the fiscal year ended December 31, 2023, or the Form 10-K, filed with the SEC. The balance sheet amounts in this report were derived from the Company’s audited consolidated financial statements included in the Form 10-K.

The condensed 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 condensed consolidated financial statements in conformity with 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 three and six months ended June 30, 2024 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 condensed 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 condensed 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.

At June 30, 2024, the Company had total assets of $799.9 million, of which $306.7 million consisted of cash and short-term investments. More specifically, the Company had current assets of $701.8 million, including cash and cash equivalents of $215.9 million, short-term investments of $90.7 million, accounts receivable, net, of $123.7 million and current inventory of $239.4 million. In addition, as of June 30, 2024, the Company had long-term inventory of $71.3 million. As of June 30, 2024, the Company had no debt outstanding.

(2) Significant Accounting Policies

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 promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. For a complete discussion of accounting for net product revenue and licensing revenue, see Note 7—Revenue Recognition.

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.

The following table summarizes the impact of accounts receivable reserves on the gross trade accounts receivable balances as of June 30, 2024 and December 31, 2023:


In thousands	June 30, 2024			December 31, 2023
Gross trade accounts receivable	$	150,631		$	160,686
Trade allowances		(19,347	)		(18,834	)
Chargebacks		(7,593	)		(8,289	)
Accounts receivable, net	$	123,691		$	133,563

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 inventory is expected beyond the next 12 months. The Company classifies finished goods expected to be sold within the next 12 months, and all of VASCEPA's active pharmaceutical ingredient, or API, as current inventory. An allowance is established when management determines that certain inventories may not be saleable. 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.

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 condensed 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 stock-based payments are recognized as an income tax benefit and expense, respectively, in the condensed 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 state tax authorities. The Company is currently under audit by the IRS for its 2018 and 2019 U.S. income tax returns. 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 condensed consolidated financial position or results of operations.

Earnings (Loss) per Share

Basic net earnings (loss) per share is determined by dividing net income (loss) by the weighted average shares of common stock outstanding during the period. Diluted net earnings (loss) per share is determined by dividing net income (loss) by diluted weighted average shares outstanding. Diluted weighted average shares reflects the dilutive effect, if any, of potentially dilutive common shares, such as 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 income (loss) and the number of shares used to compute basic and diluted net earnings (loss) per share for the three and six months ended June 30, 2024 and 2023 are as follows:


	For the Three Months Ended June 30,					For the Six Months Ended June 30,
In thousands	2024		2023			2024			2023
Net income (loss)—basic and diluted	$	1,522	$	(17,560	)	$	(8,431	)	$	(34,020	)
Weighted average shares outstanding—basic and diluted		410,851		407,848			410,565			407,017
Effect of dilutive securities:
Restricted stock and restricted stock units		545		—			—			—
Stock options		—		—			—			—
Weighted average shares outstanding—diluted		411,395		407,848			410,565			407,017
Earnings (loss) per share—basic	$	0.00	$	(0.04	)	$	(0.02	)	$	(0.08	)
Earnings (loss) per share—diluted	$	0.00	$	(0.04	)	$	(0.02	)	$	(0.08	)

(1) Excluding the licensing revenue change in estimates discussed in Note 7 – Revenue Recognition, net earnings per share, basic and diluted, for the three months ended June 30, 2024 would have been a loss per share of $(0.01) and net loss per share for the three months ended June 30, 2023 would have been $(0.06) and net loss per share for the six months ended June 30, 2024 and 2023 would have been $(0.03) and $(0.10), respectively.

For the three and six months ended June 30, 2024 and 2023, the following potentially dilutive securities were not included in the computation of net earnings (loss) per share because the effect would be anti-dilutive or because performance criteria were not yet met for awards contingent upon such measures:


	For the Three Months Ended June 30,				For the Six Months Ended June 30,
In thousands	2024		2023		2024		2023
Stock options		24,792		16,000		25,337		16,000
Restricted stock and restricted stock units		14,926		14,903		14,926		14,903

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.

Concentration of Credit Risk

Financial instruments that potentially subject the Company to credit risk consist primarily of cash and cash equivalents, short-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 28%, 34%, and 29%, respectively, of gross product sales for the six months ended June 30, 2024, and represented 40%, 30%, and 21%, respectively, of the gross accounts receivable balance as of June 30, 2024. Customers A, B, and C accounted for 30%, 36%, and 28%, respectively, of gross product sales for the six months ended June 30, 2023 and represented 39%, 34%, and 22%, respectively, of the gross accounts receivable balance as of June 30, 2023. The Company has not experienced any significant write-offs of its accounts receivable. All customer accounts are actively managed and no losses in excess of amounts reserved are currently expected.

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 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.

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 (e.g., interest rates, yield curves) and inputs that are derived principally from or corroborated by observable market data by correlation or other means (market corroborated inputs).

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 June 30, 2024 and December 31, 2023 and indicate the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value:


	June 30, 2024
In thousands	Total		Level 1		Level 2		Level 3
Asset:
Money Market Fund	$	103,609	$	103,609	$	—	$	—
U.S. Treasury Securities		132,919		132,919		—		—
Repo Securities		5,000		—		5,000		—
Total	$	241,528	$	236,528	$	5,000	$	—


	December 31, 2023
In thousands	Total		Level 1		Level 2		Level 3
Asset:
U.S. Treasury Shares	$	123,992	$	123,992	$	—	$	—
Money Market Fund		99,226		99,226		—		—
Agency Securities		8,912		—		8,912		—
Repo Securities		3,250		—		3,250		—
Total	$	235,380	$	223,218	$	12,162	$	—

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

Unrealized gains or losses are not recognized until maturity, except other-than-temporary unrealized losses which are recognized in earnings in the period incurred. The Company evaluates securities with unrealized losses to determine whether such losses are other than temporary. The unrealized gain or loss for the six months ended June 30, 2024 and 2023 were both losses of less than $0.1 million. 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

The Company identifies a restructuring event as a program that is planned and controlled by management, and materially changes either the scope of the Company's business or the manner in which that business is conducted. The accounting for involuntary termination benefits that are provided pursuant to a one-time benefit arrangement are accounted for under ASC 420 – Exit or Disposal Cost Obligations whereas involuntary termination benefits that are part of an ongoing written or substantive plan are accounted for under ASC 712 – Compensation – Nonretirement Postemployment Benefits. The Company accrues a liability for termination benefits under ASC 712 when it is probable that a liability has been incurred and the amount can be reasonably estimated and under ASC 420 when the termination benefits are communicated.

In June 2023, the Company approved and subsequently announced on July 18, 2023, an Organizational Restructuring Plan, or ORP, to right-size and strengthen the Company. As part of the plan, the Company completed a reduction of its entire U.S. sales field force, as well as a reduction of approximately 30% of its non-sales positions. The Company maintained its managed care and trade organization to support U.S. commercial efforts. During the three and six months ended June 30, 2023, the Company recognized approximately $10.2 million within restructuring expense on the condensed consolidated statement of operations related to the reduction in forces.

The Company continues to assess its contractual supplier purchase obligations and has taken steps to amend supplier agreements to align supply arrangements with current and future market demand. As a result of the ongoing assessment, the Company recognized $14.3 million during the three months ended June 30, 2023 and $26.6 million during the six months ended June 30, 2023, within cost of goods sold - restructuring inventory on the condensed 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.

The following table sets forth the components of the Company's restructuring charges for the three and six months ended June 30, 2023 (none in 2024):


	For the Three Months Ended June 30,			For the Six Months Ended June 30,
In thousands	2023			2023
Restructuring expense	$	10,154		$	10,154
Vendor contract charges		(122	)		(122	)
Total restructuring expense		10,032			10,032
Restructuring inventory		14,300			26,554
Total restructuring costs incurred	$	24,332		$	36,586

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, 2023	$	13,589
Costs incurred		—
Payments		(3,361	)
Balance at June 30, 2024	$	10,228

Recent Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, and are adopted early 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 internal-use software, website development costs and milestone payments to the former shareholders of Laxdale related to the 2004 acquisition of the rights to VASCEPA, which is the result of VASCEPA receiving marketing approval in the U.S. for the MARINE indication in 2012, the REDUCE-IT indication in 2019 and marketing approval in Europe in 2021. 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 June 30, 2024, the intangible asset has an estimated weighted-average remaining useful life of 6.6 years. The carrying value as of June 30, 2024 and December 31, 2023 is as follows:


In thousands	June 30, 2024		December 31, 2023
Technology rights	$	33,188	$	33,188
Accumulated amortization