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~~Yes ☒ NONo ☐

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~~Yes ☒ NONo ☐

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.

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~~Yes ☐ NONo ☒

~~388,673,381~~394,771,523 common shares were outstanding as of ~~July 31, 2020,~~April 23, 2021, including ~~388,472,048~~394,574,581 shares held as American Depositary Shares (ADSs), each representing one Ordinary Share, 50 pence par value per share and ~~201,333~~196,942 Ordinary Shares. In addition, 2,385,078 ordinary share equivalents were issuable in exchange for outstanding preferred shares as of July 31, 2020, for a total of 391,058,459 ordinary shares and ordinary share equivalents outstanding as of July 31, 2020.

	June 30, 2020			December 31, 2019			March 31, 2021			December 31, 2020
ASSETS
Current Assets:
Cash and cash equivalents	$	214,007		$	644,588		$	290,994		$	186,964
Restricted cash		3,913			3,907			3,917			3,915
Short-term investments		336,273			—			223,742			313,969
Accounts receivable, net		124,985			116,430			151,275			154,574
Inventory		124,844			76,769			230,892			188,864
Prepaid and other current assets		23,589			13,311			29,696			30,947
Total current assets		827,611			855,005			930,516			879,233
Property, plant and equipment, net		2,316			2,361			1,862			2,016
Long-term investments		61,039			—			24,004			62,469
Operating lease right-of-use asset		8,291			8,511			7,958			8,054
Other long-term assets		1,074			1,074			456			432
Intangible asset, net		14,538			15,258			25,456			13,817
TOTAL ASSETS	$	914,869		$	882,209		$	990,252		$	966,021
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable	$	86,757		$	49,950		$	94,262		$	105,876
Accrued expenses and other current liabilities		168,549			139,826			228,734			198,641
Debt from royalty-bearing instrument		22,455			50,130
Deferred revenue, current		5,706			2,342
Current deferred revenue								2,773			2,926
Total current liabilities		283,467			242,248			325,769			307,443
Long-Term Liabilities:
Deferred revenue, long-term		14,507			18,504
Long-term deferred revenue								15,197			15,706
Long-term operating lease liability		9,311			9,443			9,015			9,153
Other long-term liabilities		4,821			3,751			5,660			6,214
Total liabilities		312,106			273,946			355,641			338,516
Commitments and contingencies (Note 6)
Commitments and contingencies (Note 5)
Stockholders’ Equity:
Series A Convertible Preferred Stock, £0.05 par, unlimited authorized; 51,603,780 shares issued and outstanding as of June 30, 2020 (equivalent to 5,160,378 ordinary shares upon future consolidation and redesignation at a 10:1 ratio) and 289,317,460 shares issued and outstanding as of December 31, 2019 (equivalent to 28,931,746 ordinary shares upon future consolidation and redesignation at a 10:1 ratio)		7,166			21,850
Common stock, £0.50 par, unlimited authorized; 391,589,312 issued, 385,847,517 outstanding as of June 30, 2020; 365,014,893 issued, 360,103,901 outstanding as of December 31, 2019		285,672			269,173
Common stock, £0.50 par, unlimited authorized; 401,655,725 shares issued, 394,764,841 shares outstanding as of March 31, 2021; 398,425,000 shares issued, 392,538,081 shares outstanding as of December 31, 2020								292,360			290,115
Additional paid-in capital		1,787,492			1,764,317			1,831,388			1,817,649
Treasury stock; 5,741,795 shares as of June 30, 2020; 4,910,992 shares as of December 31, 2019		(50,252	)		(35,900	)
Treasury stock; 6,890,884 shares as of March 31, 2021; 5,886,919 shares as of December 31, 2020								(58,334	)		(51,082	)
Accumulated deficit		(1,427,315	)		(1,411,177	)		(1,430,803	)		(1,429,177	)
Total stockholders’ equity		602,763			608,263			634,611			627,505
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	914,869		$	882,209		$	990,252		$	966,021

	Three months ended June 30,					Six months ended June 30,						Three months ended March 31,
	2020		2019			2020			2019			2021			2020
Product revenue, net	$	133,724	$	100,366		$	285,928		$	173,097		$	141,383		$	152,204
Licensing and royalty revenue		1,593		426			4,382			973			787			2,789
Total revenue, net		135,317		100,792			290,310			174,070			142,170			154,993
Less: Cost of goods sold		28,797		22,770			63,604			39,910			28,326			34,807
Gross margin		106,520		78,022			226,706			134,160			113,844			120,186
Operating expenses:
Selling, general and administrative		92,395		73,406			226,332			145,039			105,798			133,937
Research and development		9,969		7,130			20,247			14,372			9,377			10,278
Total operating expenses		102,364		80,536			246,579			159,411			115,175			144,215
Operating income (loss)		4,156		(2,514	)		(19,873	)		(25,251	)
Interest income (expense), net		151		789			1,359			(908	)
Other income (expense), net		108		(95	)		17			(92	)
Income (loss) from operations before taxes		4,415		(1,820	)		(18,497	)		(26,251	)
Income tax benefit		—		—			2,359			—
Net income (loss)	$	4,415	$	(1,820	)	$	(16,138	)	$	(26,251	)
Earnings (loss) per share:
Operating loss													(1,331	)		(24,029	)
Interest income, net													471			1,208
Other expense, net													(142	)		(91	)
Loss from operations before taxes													(1,002	)		(22,912	)
Income tax (provision) benefit													(624	)		2,359
Net loss												$	(1,626	)	$	(20,553	)
Loss per share:
Basic	$	0.01	$	(0.01	)	$	(0.04	)	$	(0.08	)	$	(0.00	)	$	(0.06	)
Diluted	$	0.01	$	(0.01	)	$	(0.04	)	$	(0.08	)	$	(0.00	)	$	(0.06	)
Weighted average shares:
Basic		384,663		330,863			373,300			329,793			394,638			361,136
Diluted		399,664		330,863			373,300			329,793			394,638			361,136

Preferred
Shares

Common
Shares

Treasury
Shares

Preferred
Stock

Common
Stock

Additional
Paid-in
Capital

Treasury
Stock

Accumulated
Deficit

Total

December 31, 2019

289,317,460

365,014,893

(4,910,992
)

$
21,850

$
269,173

$
1,764,317

$
(35,900
)

$
(1,411,177
)

$
608,263

Exercise of stock options

—

412,465

—

—

269

1,037

—

—

1,306

Vesting of restricted stock units

—

1,951,448

(759,832
)

—

1,274

(1,274
)

(13,831
)

—

(13,831
)
Stock-based compensation

—

—

—

—

—

10,591

—

—

10,591

Net Loss

—

—

—

—

—

—

—

(20,553
)

(20,553
)
March 31, 2020

289,317,460

367,378,806

(5,670,824
)

$
21,850

$
270,716

$
1,774,671

$
(49,731
)

$
(1,431,730
)

$
585,776

Issuance of common stock under employee stock purchase plan

—

123,608

—

—

76

772

—

—

848

Conversion of Series A Convertible Preferred Stock, net

(237,713,680
)

23,771,368

—

(14,684
)

14,684

(238
)

—

—

(238
)
Exercise of stock options

—

148,290

—

—

92

260

—

—

352

Vesting of restricted stock units

—

167,240

(70,971
)

—

104

(104
)

(521
)

—

(521
)
Stock-based compensation

—

—

—

—

—

12,131

—

—

12,131

Net Income

—

—

—

—

—

—

—

4,415

4,415

June 30, 2020

51,603,780

391,589,312

(5,741,795
)

$
7,166

$
285,672

$
1,787,492

$
(50,252
)

$
(1,427,315
)

$
602,763


	Preferred Shares		Common Shares		Treasury Shares			Preferred Stock		Common Stock		Additional Paid-in Capital			Treasury Stock			Accumulated Deficit			Total
December 31, 2020		—		398,425,000		(5,886,919	)	$	—	$	290,115	$	1,817,649		$	(51,082	)	$	(1,429,177	)	$	627,505
Exercise of stock options		—		783,320		—			—		536		1,523			—			—			2,059
Vesting of restricted stock units		—		2,447,405		(1,003,965	)		—		1,709		(1,709	)		(7,252	)		—			(7,252	)
Stock-based compensation		—		—		—			—		—		13,925			—			—			13,925
Loss for the period		—		—		—			—		—		—			—			(1,626	)		(1,626	)
March 31, 2021		—		401,655,725		(6,890,884	)	$	—	$	292,360	$	1,831,388		$	(58,334	)	$	(1,430,803	)	$	634,611

	Preferred Shares		Common Shares		Treasury Shares			Preferred Stock		Common Stock		Additional Paid-in Capital			Treasury Stock			Accumulated Deficit			Total
December 31, 2018		289,317,460		329,110,863		(3,260,850	)	$	21,850	$	246,663	$	1,282,762		$	(10,413	)	$	(1,388,532	)	$	152,330
																								Preferred Shares		Common Shares		Treasury Shares			Preferred Stock		Common Stock		Additional Paid-in Capital			Treasury Stock			Accumulated Deficit			Total
December 31, 2019																									289,317,460		365,014,893		(4,910,992	)	$	21,850	$	269,173	$	1,764,317		$	(35,900	)	$	(1,411,177	)	$	608,263
Exercise of stock options		—		3,838,739		—			—		2,496		12,960			—			—			15,456			—		412,465		—			—		269		1,037			—			—			1,306
Vesting of restricted stock units		—		1,416,124		(526,708	)		—		929		(929	)		(9,080	)		—			(9,080	)		—		1,951,448		(759,832	)		—		1,274		(1,274	)		(13,831	)		—			(13,831	)
Stock-based compensation		—		—		—			—		—		6,596			—			—			6,596			—		—		—			—		—		10,591			—			—			10,591
Net Loss		—		—		—			—		—		—			—			(24,431	)		(24,431	)
March 31, 2019		289,317,460		334,365,726		(3,787,558	)	$	21,850	$	250,088	$	1,301,389		$	(19,493	)	$	(1,412,963	)	$	140,871
Issuance of common stock under employee stock purchase plan		—		47,358		—			—		30		807			—			—			837
Exercise of stock options		—		619,404		—			—		396		1,492			—			—			1,888
Vesting of restricted stock units		—		116,937		(54,057	)		—		74		(74	)		(1,040	)		—			(1,040	)
Stock-based compensation		—		—		—			—		—		8,351			—			—			8,351
Net Loss		—		—		—			—		—		—			—			(1,820	)		(1,820	)
June 30, 2019		289,317,460		335,149,425		(3,841,615	)	$	21,850	$	250,588	$	1,311,965		$	(20,533	)	$	(1,414,783	)	$	149,087
Loss for the period																									—		—		—			—		—		—			—			(20,553	)		(20,553	)
March 31, 2020																									289,317,460		367,378,806		(5,670,824	)	$	21,850	$	270,716	$	1,774,671		$	(49,731	)	$	(1,431,730	)	$	585,776

	Six months ended June 30,						Three months ended March 31,
	2020			2019			2021			2020
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$	(16,138	)	$	(26,251	)	$	(1,626	)	$	(20,553	)
Adjustments to reconcile loss to net cash provided by (used in) operating activities:
Adjustments to reconcile loss to net cash (used in) provided by operating activities:
Depreciation and amortization		296			6			150			146
Amortization of investments		33			—
Amortization (accretion) of investments								649			(151	)
Stock-based compensation		22,722			14,766			13,925			10,591
Amortization of debt discount and debt issuance costs		490			878			—			289
Amortization of intangible asset		720			323			361			360
Changes in assets and liabilities:
Accounts receivable, net		(8,555	)		(28,875	)		3,299			(41,858	)
Inventory		(48,075	)		11,534			(42,028	)		(15,352	)
Prepaid and other current assets		(10,273	)		(4,158	)		1,251			(7,416	)
Other long-term assets		—			(928	)		(24	)		—
Interest receivable		(1,312	)		—			118			(1,021	)
Accrued interest payable		(240	)		(81	)		—			(111	)
Deferred revenue		(633	)		(973	)		(662	)		961
Accounts payable and other current liabilities		65,530			14,765			6,479			79,285
Other long-term liabilities		1,159			(3,186	)		(596	)		(1,033	)
Net cash provided by (used in) operating activities		5,724			(22,180	)
Net cash (used in) provided by operating activities								(18,704	)		4,137
CASH FLOWS FROM INVESTING ACTIVITIES:
Sale and maturities of securities		131,440			—			127,925			17,077
Purchases of securities		(527,479	)		—			—			(310,648	)
Disposal of furniture, fixtures and equipment								4			—
Purchases of furniture, fixtures and equipment		(251	)		(801	)		—			(251	)
Net cash used in investing activities		(396,290	)		(801	)
Net cash provided by (used in) investing activities								127,929			(293,822	)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock, net of transaction costs		848			837
Proceeds from exercise of stock options, net of transaction costs		1,658			17,344			2,059			1,306
Payment of transaction costs for conversion of preferred stock		(238	)		—
Payment on debt from royalty-bearing instrument		(27,925	)		(12,533	)		—			(13,330	)
Taxes paid related to stock-based awards		(14,352	)		(10,120	)		(7,252	)		(13,831	)
Net cash used in financing activities		(40,009	)		(4,472	)		(5,193	)		(25,855	)
NET DECREASE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH		(430,575	)		(27,453	)
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH								104,032			(315,540	)
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD		648,495			250,727			190,879			648,495
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH, END OF PERIOD	$	217,920		$	223,274		$	294,911		$	332,955
Supplemental disclosure of cash flow information:
Cash paid during the year for:
Interest	$	1,193		$	14,982		$	—		$	875
Income taxes	$	20		$	71		$	5		$	—
Supplemental disclosure of non-cash transactions:
Initial recognition of operating lease right-of-use asset	$	—		$	8,995
Laxdale Milestone							$	12,000		$	—

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

Amarin Corporation plc, or Amarin, or the Company, is a pharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health and reduce cardiovascular risk.

The Company’s lead product, VASCEPA^® (icosapent ethyl), was first approved by the ~~U.S.~~United States Food and Drug Administration, or U.S. FDA, in July 2012 for use as an adjunct to diet to reduce triglyceride, or TG, levels in adult patients with severe (>500 mg/dL) hypertriglyceridemia. In January 2013, the Company launched 1-gram size VASCEPA in the United States, or U.S., and in October 2016, introduced a smaller 0.5-gram capsule size. On December 13, 2019, the U.S. FDA approved ~~a new~~an indication and label expansion for VASCEPA based on the ~~landmark~~ results of ~~our~~the Company’s long-term cardiovascular outcomes trial, REDUCE-IT^®, or Reduction of Cardiovascular Events with EPA – Intervention Trial. VASCEPA is ~~the first and only drug~~ approved by the U.S. FDA as an adjunct to maximally tolerated statin therapy for reducing persistent cardiovascular risk in select high risk patients. VASCEPA is available in the United States, or the U.S., by prescription only. In January 2013, the Company began selling and marketing 1-gram size VASCEPA capsules in the United States, and in October 2016, introduced a smaller 0.5-gram capsule size. VASCEPA is also available for sale by prescription only in Canada, Lebanon and the United Arab Emirates through collaborations and is also in development in other jurisdictions.

The Company, since inception, has devoted substantial resources to research and development efforts, most significantly, the development and conduct of a long-term cardiovascular outcomes study of VASCEPA, REDUCE-IT. The Company announced topline results from REDUCE-IT on September 24, 2018. On November 10, 2018, the Company presented primary results of REDUCE-IT at the 2018 Scientific Sessions of the American Heart Association, or AHA, and the results were concurrently published in ~~The New England Journal~~ of ~~Medicine~~. REDUCE-IT met its primary endpoint demonstrating a 25% relative risk reduction, or RRR, to a high degree of statistical significance (p<0.001), in first occurrence of major adverse cardiovascular events, or MACE, in the intent-to-treat patient population with use of VASCEPA 4 grams/day as compared to placebo. REDUCE-IT also showed a 26% RRR in its key secondary composite endpoint of cardiovascular death, heart attacks and stroke (p<0.001). On March 18, 2019, the Company publicly presented the total cardiovascular events results, and the method of calculating such events, of the REDUCE-IT study at the American College of Cardiology’s, or ACC, 68^th ~~Annual Scientific Session and such results and methods were concurrently published in the~~ ~~Journal of the American College of Cardiology.~~

The FDA granted Priority Review designation to the Company’s March 2019 supplemental new drug application, or sNDA, seeking an expanded indication for VASCEPA in the United States based on the positive results of the REDUCE-IT study. In November 2019, the FDA held an Endocrinologic and Metabolic Drugs Advisory Committee, or EMDAC, meeting to review the REDUCE-IT sNDA. The EMDAC voted unanimously (16-0) to recommend approval of an indication and label expansion for VASCEPA to reduce cardiovascular events in high-risk patients based on the REDUCE-IT results. On December 13, 2019, the FDA approved a new indication and related label expansion based on REDUCE-IT. Reflecting the robust results of the clinical development program for VASCEPA, no additional post-approval clinical study or other special post-approval requirement (as often seen with other drug approvals) was requested by the FDA in conjunction with its approval of VASCEPA.

In the United States, the Company sells VASCEPA principally to a limited number of major wholesalers, as well as selected regional wholesalers and specialty pharmacy providers, or collectively, its distributors or its customers, that in turn resell VASCEPA to retail pharmacies for subsequent resale to patients and healthcare providers. The Company markets VASCEPA in the United States through its direct sales force. Prior to the REDUCE-IT results topline announcement in September 2018, the Company’s commercialization of VASCEPA was somewhat limited. Subsequent to learning the positive cardiovascular outcomes results of the REDUCE-IT study, the Company increased its promotional efforts. Based on the positive REDUCE-IT results, in early 2019, the Company increased the size of its sales force to approximately 440 sales professionals, including approximately 400 sales representatives. As a result of the FDA’s newly approved indication and label expansion, in early 2020 the Company completed the expansion of its direct sales force to approximately 900 sales professionals, including 800 sales representatives. In addition to promotion of VASCEPA in the United States, based on REDUCE-IT, the Company has increased focus on expansion of the Company’s development efforts for VASCEPA to major markets outside the United States. The Company currently has strategic collaborations to develop and commercialize VASCEPA in select territories outside the United States. The Company operates in 1 business segment.

On March 30, 2020, the United States District Court for the District of Nevada, or the Nevada Court, ruled in favor of two ~~generic~~generics companies in Amarin’s patent litigation related to its abbreviated new drug applications, or ANDAs, that seek U.S. FDA approval for sale of generic versions of ~~VASCEPA.~~VASCEPA for the original indication of VASCEPA as an adjunct to diet to reduce TG levels in adult patients with severe (>500 mg/dL) hypertriglyceridemia. On May 22, 2020 ~~one of~~and August 10, 2020, the two ~~generic~~generics companies, Hikma Pharmaceutical USA Inc., or Hikma, and Dr. Reddy’s Laboratories, Inc., or Dr. Reddy’s, respectively, received U.S. FDA approval to market its generic ~~version~~versions of VASCEPA. ~~To date, Hikma has not launched~~On September 3, 2020, the U.S. Court of Appeals for the Federal Circuit, or the Federal Circuit, upheld the March ruling by the Nevada Court in favor of the two generics companies. On October 2, 2020, the Company filed a ~~generic version~~combined petition for panel rehearing or rehearing en banc. On November 4, 2020, the Company’s rehearing and en banc petitions were denied. On February 11, 2021, Amarin filed a petition for a writ of ~~VASCEPA. The Company disagrees~~certiorari with the ~~Nevada Court’s decision that its patents are invalid and~~United States Supreme Court to ask the Court to hear the Company’s appeal in this litigation, which is ~~vigorously pursuing an appeal. If generic~~pending.

~~companies determine~~In August 2020, the Company announced plans to launch ~~generic versions~~icosapent ethyl under the brand name VAZKEPA, hereinafter along with the U.S. brand name VASCEPA, collectively referred to as VASCEPA, in major markets in Europe through the Company’s new European sales and marketing teams. On January 29, 2021, the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, adopted a positive opinion, recommending that a marketing authorization be granted to icosapent ethyl in the ~~United States, such competition could~~European Union, or EU, for the reduction of risk of cardiovascular events in patients at high cardiovascular risk. On March 26, 2021, the European Commission, or EC, approved the marketing authorization application for VAZKEPA in the EU to reduce the risk of cardiovascular events in high-risk, statin-treated adult patients who have ~~a material~~elevated triglycerides (>150 mg/dL) and ~~adverse impact on our revenues~~either established cardiovascular disease or diabetes and ~~our operations.~~at least one additional cardiovascular risk event. On April 22, 2021, the Company announced that the Medicines and Healthcare Products Regulatory Agency, or MHRA, approved VAZKEPA in England, Scotland and Wales to reduce cardiovascular risk through MHRA’s new ‘reliance’ route following the end of the BREXIT transition period.

In November 2020, the Company announced topline results from the Phase 3 clinical trial of VASCEPA ~~is not yet known to most healthcare professionals~~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 ~~generics companies rarely invest in product~~Hong Kong have commenced. The Chinese National Medical Products Administration, or ~~disease state related market education. Furthermore,~~NMPA, has accepted for review the new drug application for VASCEPA ~~is relatively expensive to manufacture and already sold at an affordable price as documented by third-party analysis such that saving, if any,~~based on the ~~price~~results from the Phase 3 clinical trial and the results from the Company’s prior studies of ~~generic~~VASCEPA. The Hong Kong Department of Health is evaluating VASCEPA ~~is likely to come at the expense of reduced market education and development. Thus, the Company believes that the launch of a generic version of VASCEPA~~based on current approvals in the United States ~~at this early stage~~and Canada.

The Company currently has strategic collaborations to develop and commercialize VASCEPA in the life cycle of VASCEPA is potentially harmful to patient care and discourages new product development, including for identifying and pursuing additional indications that could be treated with VASCEPA.

Geographies outside the United States in which VASCEPA is sold and under regulatory review are not subject to this U.S. patent litigation and judgment. No similar litigation involving potential generic versions of VASCEPA is pendingselect territories outside the United States. Amarin is responsible for supplying VASCEPA to all markets in which the product is ~~currently available by prescription~~sold, including in Canada, Lebanon and the United Arab ~~Emirates. In Canada, VASCEPA has~~Emirates where the ~~benefit of eight years of data protection afforded through Health Canada (until the end of 2027), in addition to separate patent protection~~drug is promoted and sold via collaboration with ~~expiration dates~~third-party companies that ~~could extend into 2039.~~compensate Amarin for such supply. Amarin is ~~pursuing additional regulatory approvals~~not responsible for ~~VASCEPA~~providing any generic company with drug product. The Company operates in Europe, China and the Middle East. In China and the Middle East, Amarin is pursuing such regulatory approvals and subsequent commercialization of VASCEPA with commercial partners. In Europe, Amarin is preparing to self-launch VASCEPA, although it may engage commercialization partners for certain of the smaller countries of Europe. Ten to eleven years of market protection is anticipated due to regulatory exclusivity in the European Union subject to an approval recommendation by the European Medicines Agency, or EMA, in early 2021 and associated European Community, or EC, approval expected promptly thereafter, in addition to pending patent protection that could extend into 2039.1 business segment.

The condensed consolidated financial statements included herein have been prepared by the Company ~~without audit,~~ 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. 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, 2019,~~ or the ~~2019~~ Form 10-K, filed with the SEC. The balance sheet amounts ~~at December 31, 2019~~ in this report were derived from the Company’s audited ~~2019~~ consolidated financial statements included in the ~~2019~~ 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 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 three ~~and six~~ months ended ~~June 30, 2020~~March 31, 2021 are not necessarily indicative of the results for ~~the entire fiscal year or~~ 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, as well as the current global pandemic, COVID-19.

AsAt March 31, 2021, the Company had Total assets of ~~June 30, 2020,~~$990.3 million, of which $538.7 million consisted of cash and liquid short-term and long-term investments. More specifically, the Company had Current assets of ~~$827.6~~$930.5 million, including Cash and cash equivalents of ~~$214.0~~$291.0 million, Short-term investments of ~~$336.3~~$223.7 million, Accounts receivable, net, of ~~$125.0~~$151.3 million and Inventory of ~~$124.8~~$230.9 million. In addition, as of ~~June 30, 2020,~~March 31, 2021, the Company ~~has~~had Long-term investments of ~~$61.0~~$24.0 million. ~~The Company’s condensed consolidated balance sheets also include a royalty-bearing instrument which is expected to be fully paid during 2020 based on projected VASCEPA net revenues.~~ As of ~~June 30, 2020,~~March 31, 2021, the Company had 0 ~~other~~ debt outstanding.

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 9—8—Revenue Recognition.

Cash and cash equivalents consist of cash, deposits with banks and short-term highly liquid money market instruments with remaining maturities at the date of purchase of 90 days or less. 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, comprised of trade receivables, are generally due within 30 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 as of ~~June 30, 2020~~March 31, 2021 and December 31, ~~2019:~~2020:

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. 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 active pharmaceutical ingredient, or API.

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 ~~tax provision,~~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 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 states. The Company is currently under audit by the IRS ~~began an examination of~~for the Company’s 2018 U.S. income tax return inand by the ~~first quarter~~New Jersey Department of ~~2020.~~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 ~~this audit~~these audits will have a material adverse effect on its consolidated financial position or results of operations.

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

average shares reflects the dilutive effect, if any, of potentially dilutive common shares, such as common stock options calculated using the treasury stock method and ~~convertible~~ preferred stock and convertible notes using the “if-converted” method. In periods with reported net operating losses, all common stock options and preferred stock outstanding are deemed anti-dilutive such that basic net loss per share and diluted net loss per share are equal.

The Company’s preferred stock, of which none is outstanding as of March 31, 2021 and December 31, 2020, was entitled to receive dividends on an as-if-converted basis in the same form as dividends actually paid on common shares. Accordingly, the preferred stock iswas considered a participating security and the Company iswas required to apply the two-class method to consider the impact of the preferred stock on the calculation of basic and diluted earnings per share. The Company is ~~currently~~in a net loss position for the periods presented and is therefore not required to present the two-class method, however, in the event the Company was historically in a net income position, ~~for the three months ended June 30, 2020 and therefore~~ the two-class method ~~must be~~was applied ~~for this period~~ by allocating all earnings during the period to common shares and preferred stock based on their contractual entitlements assuming all earnings ~~are~~were distributed. ~~The Company is in a net loss position for all other periods presented below and is therefore not required to apply the two-class method for those other periods.~~

The calculation of net ~~income (loss)~~loss and the number of shares used to compute basic and diluted net ~~earnings (loss)~~loss per share for the three ~~and six~~ months ended ~~June 30,~~March 31, 2021 and 2020 ~~and 2019~~ are as follows:

Three months ended June 30,

Six months ended June 30,

In thousands

2020

2019

2020

2019

Net income (loss)—basic and diluted

$
4,415

$
(1,820
)

$
(16,138
)

$
(26,251
)
Weighted average shares outstanding—basic

384,663

330,863

373,300

329,793

Effect of dilutive securities:

Stock options

6,372

—

—

—

Restricted stock and restricted stock units

1,640

—

—

—

Preferred stock, if converted

6,989

—

—

—

Weighted average shares outstanding—diluted

399,664

330,863

373,300

329,793

Net income (loss) per share—basic

$
0.01

$
(0.01
)

$
(0.04
)

$
(0.08
)
Net income (loss) per share—diluted

$
0.01

$
(0.01
)

$
(0.04
)

$
(0.08
)

	Three months ended March 31,
In thousands	2021			2020
Net loss—basic and diluted	$	(1,626	)	$	(20,553	)
Weighted average shares outstanding—basic and diluted		394,638			361,136
Net loss per share—basic and diluted	$	(0.00	)	$	(0.06	)

For the three ~~and six~~ months ended ~~June 30,~~March 31, 2021 and 2020, ~~and 2019,~~ the following potentially dilutive securities were not included in the computation of net ~~earnings (loss)~~loss per share because the effect would be ~~anti-dilutive or because performance criteria were not yet met for awards contingent upon such measures:~~anti-dilutive:

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.

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. NaN customers individually accounted for 10% or more of the Company’s gross product ~~sales.~~sales, Customers A, B, and C accounted for ~~25%~~27%, ~~37%~~35%, and ~~29%~~31%, respectively, of gross product sales for the ~~six~~three months ended ~~June 30, 2020,~~March 31, 2021, and represented ~~32%~~35%, ~~38%~~36%, and ~~23%~~24%, respectively, of the gross accounts receivable balance as of ~~June 30, 2020.~~March 31, 2021. Customers A, B, and C accounted for 24%, ~~37%~~35%, and ~~29%~~32%, respectively, of gross product sales for the ~~six~~three months ended ~~June 30, 2019~~March 31, 2020 and represented ~~38%~~32%, ~~32%~~27%, and ~~22%~~30%, respectively, of the gross accounts receivable balance as of ~~June 30, 2019.~~March 31, 2020. 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; however, the Company is monitoring the potential negative impact of COVID-19 on the Company’s customers’ ability to meet their financial obligations.

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 U.S. FDA-approved API manufacturers and several independent U.S. FDA-approved API encapsulators and packagers for VASCEPA manufacturing. Each of these companies has qualified and validated its manufacturing processes and is capable of manufacturing VASCEPA. 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 ~~the Company’s~~its specifications or that these and any future suppliers will have the manufacturing capacity to meet ~~anticipated~~potential global demand for VASCEPA.

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 ~~June 30, 2020~~March 31, 2021 and December 31, ~~2019~~2020 and indicate the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value:

	June 30, 2020								March 31, 2021
In thousands	Total		Level 1		Level 2		Level 3		Total		Level 1		Level 2		Level 3
Asset:
Money Market Fund	$	78,795	$	78,795	$	—	$	—	$	177,426	$	177,426	$	—	$	—
U.S. Treasury Shares		65,626		65,626		—		—		31,673		31,673		—		—
Corporate Bonds		231,022		—		231,022		—		130,114		—		130,114		—
Commercial Paper		102,281		—		102,281		—		47,517		—		47,517		—
Agency Securities										20,708		—		20,708		—
Repo Securities		12,000		—		12,000		—		10,000		—		10,000		—
Asset Backed Securities		11,605		—		11,605		—		5,411		—		5,411		—
Certificate of Deposit		6,121		—		6,121		—		6,124		—		6,124		—
Agency Securities		4,925		—		4,925		—
Non-US Government										5,234				5,234
Total	$	512,375	$	144,421		367,954	$	—	$	434,207	$	209,099	$	225,108	$	—

	December 31, 2019								December 31, 2020
In thousands	Total		Level 1		Level 2		Level 3		Total		Level 1		Level 2		Level 3
Asset:
Money Market Fund	$	10,078	$	10,078	$	—	$	—	$	88,266	$	88,266	$	—	$	—
U.S. Treasury Shares										48,356		48,356		—		—
Corporate Bonds										179,864		—		179,864		—
Commercial Paper										106,650		—		106,650		—
Agency Securities										20,782		—		20,782		—
Repo Securities										10,000		—		10,000		—
Asset Backed Securities										8,599		—		8,599		—
Certificate of Deposit										6,125		—		6,125		—
Non-US Government										5,240		—		5,240		—
Total									$	473,882	$	136,622	$	337,260	$	—

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 ~~consists~~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 maturities greater than 90 days and less than twelve months are included in short-term investments on its condensed consolidated balance sheet. Those with remaining maturities in excess of twelve months are included in long-term investments on its condensed 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 three months ended March 31, 2021 and 2020 was a gain of $0.2 million and a loss of $0.7 million, respectively. Interest on investments is reported in interest income. ~~The unrealized gain for the six months ended June 30, 2020 and 2019 was $1.3 million and nil, respectively.~~

The carrying amounts of accounts payable and accrued liabilities approximate fair value because of their short-term nature. The carrying amounts and the estimated fair values of debt from royalty-bearing instrument as of June 30, 2020 and December 31, 2019 are as follows:

The estimated fair value of the debt from royalty-bearing instrument is calculated utilizing the same Level 3 inputs utilized in valuing the related derivative liability (see Derivative Liabilities below). The carrying value of the debt from royalty-bearing instrument is net of the unamortized debt discounts and issuance costs as of both June 30, 2020 and December 31, 2019. The carrying value of the debt from the royalty-bearing instrument as of June 30, 2020 approximates fair value because the instrument is expected to be fully paid during 2020 based on projected VASCEPA net revenues.

Derivative financial liabilities are recorded at fair value, with gains and losses arising for changes in fair value recognized in the condensed consolidated statement of operations at each period end while such instruments are outstanding. If the Company issues shares to discharge the liability, the derivative financial liability is derecognized and common stock and additional paid-in capital are recognized on the issuance of those shares.

The Company’s December 2012 royalty-bearing instrument financing arrangement (discussed in Note 5—Debt) contains a redemption feature whereby, upon a change of control, the Company would be required to repay $150.0 million, less any previously repaid amount. The Company determined this redemption feature to be an embedded derivative, which is carried at fair value and is classified as Level 3 in the fair value hierarchy due to the use of significant unobservable inputs. The fair value of the embedded derivative was calculated using a probability-weighted model incorporating management estimates of future revenues and for a potential change in control, and by determining the fair value of the debt with and without the change in control provision included. The difference between the two was determined to be the fair value of the embedded derivative. The fair value of this derivative liability is remeasured at each reporting period, with changes in fair value recognized in the condensed consolidated statement of operations. As of June 30, 2020, the fair value of the derivative was determined to be nil, and the debt was valued by comparing debt issues of similar companies with (i) remaining terms of between 1.4 and 6.8 years, (ii) coupon rates of between 6.0% and 11.5% and (iii) market yields of between 6.1% and 17.6%. As of December 31, 2019, the fair value of the derivative was determined to be nil based on underlying assumptions, and the debt was valued by comparing debt issues of similar companies with (i) remaining terms of between 1.9 and 7.3 years, (ii) coupon rates of between 6.0% and 11.5% and (iii) market yields of between 5.2% and 16.8%. As such, the Company recognized 0 gain or loss on change in fair value of derivative liability for the six months ended June 30, 2020 and 2019.

Certain changes in the assumptions used to value the derivative liability, including the probability of a change in control, could potentially result in a change to the carrying value of such liability. Because the remaining amount due from this royalty-bearing instrument is fixed and anticipated to be fully paid before the end of 2020, any change in the value of this derivative liability will not have any impact on the Company’s aggregate cash payment obligation from this instrument regardless of any potential change in the carrying value of such liability.

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 1 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.

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

In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements (Topic 808), Clarifying the Interaction between Topic 808 and Topic 606, which clarified that in collaborative arrangements where the counterparty is a customer for a good or service that is a distinct unit of account is required to be accounted for under ASC 606. The Company adopted this standard effective January 1, 2020, which did not have an impact on the Company’s condensed consolidated financial statements.

~~In August 2018, the FASB issued ASU No. 2018-13,~~ ~~Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement~~, which eliminates, adds and modifies certain disclosure requirements for fair value measurements, including eliminating the requirement to disclose the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy, and requiring disclosure of the range and weighted average used to develop significant unobservable inputs for Level 3 fair value measurements. The Company adopted this standard effective January 1, 2020, which did not have a material impact on the Company’s condensed consolidated financial statements.

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments, which requires earlier recognition of credit losses on loans and other financial instruments held by entities, including trade receivables. The new standard requires entities to measure all expected credit losses for financial assets held at each reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. The Company adopted this standard effective January 1, 2020, which did not have a material impact on the Company’s condensed consolidated financial statements.

~~The Company also considered the following recent accounting pronouncement which was not yet adopted as of June 30, 2020:~~

In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740), Simplifying the Accounting for Income Taxes, which simplifies the accounting for income taxes by eliminating certain exceptions to the guidance in ASC 740 related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period, the recognition of deferred tax liabilities for outside basis differences, among other simplifications. The new guidance is effective for fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. Early adoption of all amendments in the same period is permitted. The Company ~~is currently evaluating the impact that~~adopted this standard ~~will~~effective January 1, 2021, which did not have an impact on the Company’s condensed consolidated financial statements.

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

Intangible asset consists of milestone payments to the ~~historical~~former shareholders of Laxdale related to the 2004 acquisition ~~cost~~ of ~~certain technology~~the rights to VASCEPA, which is the result of VASCEPA receiving marketing approval in the U.S. for ~~VASCEPA.~~the first indication in 2012, the expanded label in 2019 and marketing approval in Europe in 2021. Upon approval ~~by FDA on December 13, 2019~~ of ~~a new indication of VASCEPA,~~the marketing authorization application for VAZKEPA in March 2021, a milestone for £5£7.5 million was achieved, which resulted in the Intangible asset increasing by ~~$8.5~~$12.0 million. ~~The Intangible~~Refer to Note 5 – Commitments and Contingencies for further details. In accordance with ASC 350, the Company evaluates the remaining useful lives of the intangible asset ~~has an estimated weighted-average~~at each reporting period to determine if any events or circumstances warrant a revision to the remaining period of amortization. As of March 31, 2021, the Company determined the useful life of the intangible asset, which had a remaining useful life of ~~10.1 years.~~9.3 years, has been extended to 10.0 years due to the approval of VAZKEPA in Europe and the related period of market protection. The carrying value as of ~~June 30, 2020~~March 31, 2021 and December 31, ~~2019~~2020 is as follows:

The Company capitalizes its purchases of saleable inventory of VASCEPA from suppliers that have been qualified by the U.S. FDA. Inventories as of ~~June 30, 2020~~March 31, 2021 and December 31, ~~2019~~2020 consist of the following:

The active pharmaceutical ingredient in VASCEPA is difficult and time consuming to manufacture, often requires considerable advanced planning and long-term financial commitment to ensure sufficient capacity is available when needed. The Company has invested over a decade to develop with individual members of its third-party, active pharmaceutical ingredient supply chain the technical knowhow, manufacturing processes and related regulatory approvals that have helped enable the Company’s suppliers to supply the Company’s need for clinical and commercial supply globally. Based on statements made by generic competitors, Hikma and Dr. Reddy’s, the active pharmaceutical ingredient of VASCEPA needed to manufacture their generic versions of VASCEPA is in short supply to them. The Company believes this may be due to their lack of adequate planning, investment, knowhow and expertise regarding this fragile active ingredient.

As has been a practice in the generic pharmaceutical industry, on April 27, 2021, Dr. Reddy’s filed a complaint against the Company in the United States District Court District of New Jersey (case no. 2:21-cv-10309) alleging various antitrust violations stemming from ~~Royalty-Bearing Instrument—December 2012 Financing~~alleged anticompetitive practices related to the supply of active pharmaceutical ingredient of VASCEPA. Damages sought include recovery for alleged economic harm to Dr. Reddy’s, payors and consumers, treble damages and other costs and fees. Injunctive relief against the alleged violative activities is also being sought by Dr. Reddy’s. Amarin believes it has valid defenses and will vigorously defend against the claims. Amarin has also received a civil investigative demand from the U.S. Federal Trade Commission and a subpoena from the New York Attorney General with respect to information on the same topic. The Company believes such contact from the governments may have been prompted by a generic competitor. Amarin is cooperating with the government agencies. Such litigation and investigations can be lengthy, costly and could materially affect and disrupt the Company’s business. The Company cannot predict when these matters will be resolved, their outcome or their potential impact on the Company’s business. If a government determines that Amarin has violated antitrust law, the Company could be subject to significant civil fines and penalties.

On February 22, 2019, a purported investor in the Company’s publicly traded securities filed a putative class action lawsuit against Amarin Corporation plc, the chief executive officer and chief scientific officer in the U.S. District Court for the District of New Jersey, Debendra Sharma v. Amarin Corporation plc, John F. Thero and Steven Ketchum, No. 2:19-cv-06601 (D.N.J. Feb. 22, 2019). On March 12, 2019, another purported investor filed a substantially similar lawsuit captioned Richard Borghesi v. Amarin Corporation plc, John F. Thero and Steven Ketchum, No. 3:19-cv-08423 (D.N.J. March 12, 2019). On May 14, 2019 the court consolidated the cases under the caption In re Amarin Corporation PLC Securities Litigation, No. 3:19-cv-06601 and appointed two other purported shareholders, Dan Kotecki and the Gaetano Cecchini Living Trust, as Co-Lead Plaintiffs. Co-Lead Plaintiffs filed a consolidated amended complaint, or Amended Complaint, on July 22, 2019 that added as defendants the Company’s current chief medical officer and the Company’s former chief executive officer, who is a current director. The Amended Complaint alleged that from September 24, 2018 to November 9, 2018 the Company misled investors by releasing topline results for the REDUCE-IT study without disclosing data on biomarker increases in the placebo group as compared with baseline measurement. The Amended Complaint alleged that these data suggest that the mineral oil placebo used in the REDUCE-IT study may have interfered with statin absorption in the placebo group, which they alleged may have increased adverse outcomes in the placebo group. The Amended Complaint further alleged that these purported misrepresentations and omissions inflated the share price. Based on these allegations, the suit asserted claims under the Securities Exchange Act of 1934 and sought unspecified monetary damages and attorneys’ fees and costs.

On March 29, 2021, the court granted the Company’s motion to dismiss this litigation for failure to state a valid claim. The litigation was dismissed without prejudice, giving the plaintiffs the right to file an amended complaint. We intend to vigorously defend against any future complaint in this matter.

In September and October 2016, the Company received paragraph IV certification notices from four companies contending to varying degrees that certain of its patents are invalid, unenforceable and/or will not be infringed by the manufacture, use, sale or offer for sale

of a generic form of VASCEPA as described in those companies’ ANDAs. The Company filed patent infringement lawsuits against three of these four ANDA applicants. In October 2016, Amarin filed a lawsuit against Roxane Laboratories, Inc. and related parties (collectively, “Roxane”) in the Nevada Court. The case against Roxane was captioned Amarin Pharma, Inc. et al. v. Roxane Laboratories, Inc. et al., Civ. A. No. 2:16-cv-02525 (D. Nev.). According to a stipulation filed with the Nevada Court, in December ~~6, 2012,~~2016, Roxane transferred its ANDA to West-Ward Pharmaceuticals International Limited, which then designated West-Ward Pharmaceuticals Corp. (or together with West-Ward Pharmaceuticals International Limited, West-Ward) as its agent for U.S. FDA communications. In view of the ANDA transfer, in February 2017, West-Ward replaced Roxane and related parties as Defendants in the above-referenced case. The case against West-Ward was then captioned Amarin Pharma, Inc. et al. v. West-Ward Pharmaceuticals Corp. et al., Civ. A. No. 2:16-cv-02525 (D. Nev.). In November 2016, the Company filed a lawsuit against Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. (collectively, “DRL”) in the U.S. District Court for the District of Nevada. The case against DRL is captioned Amarin Pharma, Inc. et al. v. Dr. Reddy’s Laboratories, Inc. et al., Civ. A. No. 2:16-cv-02562 (D. Nev.). In November 2016, the Company filed a lawsuit against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals Industries Limited (collectively, “Teva”) in the Nevada Court. The case against Teva was captioned Amarin Pharma, Inc. et al. v. Teva Pharmaceuticals USA, Inc. et al., Civ. A. No. 2:16-cv-02658. In all three lawsuits, the Company sought, among other remedies, an order enjoining each defendant from marketing generic versions of VASCEPA before the last to expire of the asserted patents in 2030.

The fourth ANDA applicant referenced above is Apotex Inc., or Apotex, which sent the Company a paragraph IV certification notice in September 2016. The notice reflected that Apotex made a paragraph IV notice as to some, but not all, of the patents listed in the Orange Book for VASCEPA.

In October 2016, the Company introduced to the market a 0.5-gram dose strength of VASCEPA. In August 2017, as anticipated, the Company received a paragraph IV certification notice from Teva contending that certain of its patents are invalid, unenforceable and/or will not be infringed by the manufacture, use, sale or offer for sale of a generic form of the 0.5-gram dose strength of VASCEPA, as described in the Teva ANDA. This Teva ANDA was filed as an amendment to the 1-gram Teva ANDA and is related to patents already at issue in the 1-gram VASCEPA patent litigation. This certification followed the related listing in the Orange Book of patents associated with the 0.5-gram product in June 2017. This June 2017 listing was within the five-year, post NDA-approval period during which the Hatch-Waxman Amendments require a paragraph IV certification of patent invalidity or non-infringement under the Hatch-Waxman, five-year, NCE regulatory scheme. Accordingly, in October 2017, the Company filed a patent infringement lawsuit against Teva in the U.S. District Court for the District of Nevada. The case was captioned Amarin Pharma, Inc. et al. v. Teva Pharmaceuticals USA, Inc. et al., Civ. A. No. 2:17-cv-2641 (D. Nev.). In this lawsuit, the Company sought, among other remedies, an order enjoining Teva from marketing generic versions of the 0.5-gram dose strength of VASCEPA before the last to expire of the asserted patents in 2030.

On May 24, 2018, the Company entered into a ~~Purchase~~settlement agreement with Teva that resolved its ANDA patent litigation as it relates to Teva’s as amended ANDA for both the 1-gram and Sale Agreement with BioPharma Secured Debt Fund II Holdings Cayman LP, or BioPharma. Under this agreement, the Company granted to BioPharma a security interest in future receivables associated with the VASCEPA patent rights, in exchange for $100.0 million received at the closing0.5-gram dose strengths of VASCEPA. As part of the settlement agreement, ~~which occurred in December 2012. Under these terms, the Company continues~~Teva may, subject to ~~own all VASCEPA intellectual property rights, however, such rights, as described below, could be used as collateral for repayment~~procurement of the remaining unpaid balance under this agreement if the Company defaults on making required payments. In the agreement, the Company agreed to repay BioPharma up to $150.0 million with such repayment based onproduct supply, sell a ~~portion of net revenues and receivables generated from VASCEPA. On December 20, 2017, BioPharma assigned all rights under this agreement to CPPIB Credit Europe S.à r.l., or CPPIB.~~

As of June 30, 2020, the remaining amount to be repaid to CPPIB is $23.0 million. During the three and six months ended June 30, 2020, the Company made repayments under the agreement of $15.2 million and $29.4 million, respectively, to CPPIB and an additional $13.4 million is scheduled to be paid in August 2020 for the second quarter of 2020. These payments, as well as additional quarterly repayments scheduled in the future, are calculated as 10%generic version of VASCEPA net product revenues. All such payments reduce the remainder of the $150.0 million in aggregate payments to CPPIB. Except upon a change of control in Amarin, the agreement does not expire until $150.0 million in aggregate has been repaid. The Company can prepay the net remaining amount at any time.

The Company determined the redemption feature upon a change of control to be an embedded derivative requiring bifurcation. The fair value of the embedded derivative was calculated by determining the fair value of the debt with the change in control provision included and also without the change in control provision. The fair value of this derivative liability is remeasured at each reporting

period, with changes in fair value recognized in the condensed consolidated statement of operations and any changes in the assumptions used in measuring the fair value of the derivative liability could result in a material increase or decrease in its carrying value. Based on current assumptions underlying the valuation, the Company recognized 0 gain or loss on change in fair value of derivative liability during the six months ended June 30, 2020 and 2019.

As of June 30, 2020 and December 31, 2019, the carrying value of the royalty-bearing instrument, net of the unamortized debt discount and issuance costs, was $22.3 million and $49.7 million, respectively. During the six months ended June 30, 2020, the Company recorded cash and non-cash interest expense of $1.3 million and $0.5 million, respectively, in connection with the royalty-bearing instrument. During the six months ended June 30, 2019, the Company recorded $2.4 million and $0.9 million of cash and non-cash interest expense, respectively, in connection with the royalty-bearing instrument. The Company will periodically evaluate the remaining term of the agreement and the effective interest rate is recalculated each period based on the Company’s most current estimate of repayment.

To secure the obligations under the agreement, the Company granted BioPharma, which it subsequently assigned to CPPIB, a security interest in the Company’s patents, trademarks, trade names, domain names, copyrights, know-how and regulatory approvals related to the covered products, all books and records relating to the foregoing and all proceeds of the foregoing, referred to collectively as the collateral. If the Company (i) fails to deliver a payment when due and does not remedy that failure within a specific notice period, (ii) fails to maintain a first-priority perfected security interest in the collateral in the United States now that the U.S. Federal Circuit Court of Appeals issued its mandate following our Nevada Court trial appeal lost at the level. The settlement agreement with Teva also substantially resolved litigation with Teva that could have ensued related to the December 2019 cardiovascular risk reduction indication of VASCEPA based on the REDUCE-IT study.

In July 2018, as anticipated, the Company received a paragraph IV certification notice from DRL contending that certain of its patents are invalid, unenforceable and/or will not be infringed by the manufacture, use, sale or offer for sale of a generic form of the 0.5-gram dose strength of VASCEPA, as described in the DRL ANDA. This DRL ANDA was filed as an amendment to the 1-gram DRL ANDA and ~~does not remedy~~is related to patents already at issue in the 1-gram VASCEPA patent litigation. This certification followed the related listing in the Orange Book of patents associated with the 0.5-gram product in June 2017. This June 2017 listing was within the five-year, post NDA-approval period during which the Hatch-Waxman Amendments require a paragraph IV certification of patent invalidity or non-infringement lawsuit against DRL in the U.S. District Court for the District of Nevada. The case is captioned Amarin Pharma, Inc. et al. v. Dr. Reddy’s Laboratories, Inc. et al., Civ. A. No. 2:18-cv-01596 (D. Nev.). In this lawsuit, the Company sought, among other remedies, an order enjoining DRL from marketing generic versions of the 0.5-gram dose strength of VASCEPA before the last to expire of the asserted patents in 2030. In light of the overlap between the cases, DRL and the Company have stipulated that ~~failure after receiving notice~~the final judgment on the merits of ~~such failure~~the parties’ contentions in the consolidated 1-gram action shall also be binding in the 0.5-gram case.

The trial for the ANDA patent litigation against defendants DRL and Hikma, and certain of their respective affiliates, or ~~(iii) becomes~~the Defendants, took place in the Nevada Court (case no.: 2:16-cv-02525-MMD-NJK (consolidated with 2:16-cv=02562=MMD-NJK). Following conclusion of the trial in late January 2020, the Nevada Court, on March 30, 2020, decided in favor of the Defendants, ruling that the relevant patents are invalid due to obviousness. Amarin appealed this decision to the Federal Circuit (case no.: 20-1723).

In June 2020, the Company entered into a settlement agreement with Apotex that resolved patent litigation that was expected to result from the ANDA filed by Apotex with the U.S. FDA, which ANDA was amended in May 2020, seeking approval of a generic form of VASCEPA capsules based on the MARINE study. As part of the settlement agreement, Apotex may, subject to ~~an event~~U.S. FDA approval of ~~bankruptcy, then CPPIB~~

its ANDA and procurement of product supply, sell a generic version of VASCEPA with MARINE indication labeling in the United States now that the U.S. Federal Circuit Court of Appeals issued its mandate following our Nevada Court trial appeal loss at the level (the same such date provided for under the 2018 settlement agreement with Teva). The settlement agreement with Apotex also substantially resolved litigation with Apotex that could have ensued related to the December 2019 cardiovascular risk reduction indication of VASCEPA based on the REDUCE-IT study. Apotex may ~~attempt~~amend its label under our settlement agreement to ~~collect~~include the ~~maximum amount payable~~REDUCE-IT indication after expiration of the associated Hatch-Waxman Act regulatory exclusivity expires in December 2022.

On September 3, 2020, the U.S. Court of Appeal for the Federal Circuit upheld the March 2020 trial ruling by the ~~Company under this agreement (after deducting any payments~~Nevada Court in favor of Hikma and DRL. On October 2, 2020, the Company filed a combined petition for panel rehearing or rehearing en banc (case no.: 20-1723-1901), which was denied. On February 11, 2021, the Company filed a petition for a writ of certiorari with the United States Supreme Court to ask the Supreme Court to hear the appeal in this litigation (case no.: 20-1119). That petition is pending.

In November 2020, the Company filed a new patent infringement lawsuit against Hikma in the United States District Court in Delaware. The complaint alleges that Hikma has ~~already made).~~induced the infringement of VASCEPA-related cardiovascular risk reduction U.S. Patent Nos. 9,700,537 (Composition for preventing the occurrence of cardiovascular event in multiple risk patient), 8,642,077 (Stable pharmaceutical composition and methods of using same), and 10,568,861 (Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease) by making, selling, offering to sell and importing generic icosapent ethyl capsules in or into the United States. The Company is seeking remedies including a permanent injunction against Hikma’s unlawful inducement of infringing uses of its generic product to reduce cardiovascular risk and monetary damages in an amount sufficient to compensate the Company for such infringement.

~~Under~~In January 2021, the ~~agreement,~~Company expanded the scope of the VASCEPA CV risk reduction patent infringement lawsuit against Hikma to include a health care insurance provider in the United States, Health Net, LLC. Through insurance coverage and economic incentives the Company alleges that Health Net, LLC has actively induced pharmacies to dispense, and patients to use, Hikma generic icosapent ethyl capsules in infringement of the related patents. In the complaint, the Company is ~~restricted from paying dividends on~~seeking remedies including a permanent injunction against the unlawful inducement by Hikma and Health Net, LLC of infringing uses of the Hikma generic product, i.e., uses to reduce cardiovascular risk as detailed in the patents, and monetary damages in an amount sufficient to compensate the Company for such infringement. The Company is considering its ~~common shares, unless it has cash~~legal options against parties similarly situated to Health Net, LLC and ~~cash equivalents~~Hikma and acting in ~~excess~~concert with either by making or selling any drug product or component thereof covered by the subject patents, or inducing others to do the same.

The Company intends to vigorously enforce its intellectual property rights relating to VASCEPA, but cannot predict the outcome of ~~a specified amount after such payment.~~

In addition to the above, in the ordinary course of business, the Company is from time to time involved in lawsuits, claims, investigations, proceedings, and threats of litigation relating to intellectual property, commercial arrangements and other matters. ~~Refer to Item 1 Legal Proceedings of this Quarterly Report on Form 10-Q below for a discussion of the Company’s current legal proceedings.~~

The Company entered into long-term supply agreements with multiple U.S. FDA-approved API suppliers and encapsulators. Certain supply agreements require annual minimum volume commitments by the Company and certain volume shortfalls may require payments for such shortfalls.

These agreements include requirements for the suppliers to meet certain product specifications and qualify their materials and facilities with applicable regulatory authorities including the U.S. FDA. The Company has incurred certain costs associated with the qualification of product produced by these suppliers.

Pursuant to the supply agreements, there is a total of approximately ~~$146.0~~$213.0 million that is potentially payable over the term of such agreements based on minimum purchase obligations. The Company continues to meet its contractual purchase obligations.

On March 26, 2021, the EC approved the marketing authorization application for VAZKEPA. Under the 2004 share repurchase agreement with ~~Laxdale Limited or~~ Laxdale, upon receipt of marketing approval in Europe for the first indication for VASCEPA (or first indication of any product containing ~~Amarin Neuroscience Limited~~ intellectual property acquired from Laxdale in 2004), the Company must make an aggregate stock or cash payment to the former shareholders of Laxdale (at the sole option of each of the sellers) of £7.5 million. The Company recorded a liability of $12.0 million ~~(approximately $9.2 million~~in Accrued expenses and other current liabilities on the condensed consolidated balance sheet as of ~~June 30, 2020).~~ March 31, 2021.

Also under the Laxdale agreement, upon receipt of a marketing approval in Europe for a further indication of VASCEPA (or further indication of any other product ~~using Amarin Neuroscience Limited intellectual property)~~acquired from Laxdale in 2004), the Company must make an aggregate stock or cash payment (at the sole option of each of the sellers) of £5 million (approximately ~~$6.2~~$6.9 million as of ~~June 30, 2020)~~March 31, 2021) for the potential market approval.

The Company has no provision for any of ~~the~~these obligations, except as noted above, since the amounts are either not paid or payable as of ~~June 30, 2020.~~March 31, 2021.

As of March 31, 2021, the Company had certain marketing commitments, consisting of communication costs related to the direct-to-consumer activities, totaling approximately $14.2 million.

OnIn March 5, 2015, the Company entered into a subscription ~~agreement~~agreements with ~~four institutional investors, or the Purchasers, including~~ both existing and new investors, or the Purchasers, for the private placement of ~~352,150,790~~a total of 391,017,970 restricted American Depositary Shares, or ADSs, each representing

one ~~(1)~~ share of Amarin’s Series A Convertible Preference Shares, par value £0.05 per share, in the capital of the Company, or Series A Preference ~~Shares, resulting in gross proceeds to the Company of $52.8 million. The closing of the private placement occurred on March 30, 2015.~~

Shares. For each restricted ~~American Depositary Share,~~ADS, the Purchasers paid a negotiated price of $0.15 (equating to $1.50 on an as-if-converted-to-ordinary-shares basis), resulting in ~~$52.8 million in aggregate~~ gross proceeds to the Company of approximately $58.6 million before deducting estimated offering expenses of approximately $0.7 million. ~~The net proceeds are reflected as preferred stock in~~At the ~~accompanying condensed consolidated balance sheets.~~

~~Each~~request of the holders and provided certain conditions were met, each ten ~~(10)~~ Series A Preference Shares ~~may~~were able to be consolidated and redesignated as one ~~(1)~~ ordinary share, par value £0.50 per share, in the capital of the Company, each ordinary share to be represented by ~~American Depositary Shares, or ADSs, provided that consolidation will be prohibited if, as a result,~~ADSs. During the ~~holder of such Series A Preference Shares~~years ended December 31, 2020, 2018, and its affiliates would beneficially own more than 9.9% (increased from 4.99% effective March 2020) of the total number of Amarin ordinary shares or ADSs outstanding following such redesignation, or the Beneficial Ownership Limitation. By written notice to2015, the Company a holder may from time to time increase or decrease the Beneficial Ownership Limitation to any other percentage not in excess of 19.9% specified in such notice; provided that any such increase will not be effective until the sixty-first (61st) day after such notice is delivered to the Company. Thisissued 28,931,746, 3,886,718, and 6,283,333 ADSs, respectively, upon consolidation and redesignation ~~may be effected by a holder~~ of Series A Preference Shares ~~following~~at the ~~first to occur~~request of the resale of the ADSs representing the ordinary shares being registered for resale under the Securities Act pursuant to an effective registration statement, following any sale of the ADSs representing the ordinary shares pursuant to Rule 144 under the Securities Act, or ifholders, such ~~ADSs representing the ordinary shares are eligible for sale under Rule 144, following the expiration of the one-year holding requirement under Rule 144.~~

~~Except as otherwise provided in the Series A Preference Share Terms or as required by applicable law, the~~that 0 Series A Preference Shares ~~have no voting rights. However,~~remained outstanding as ~~long as any Series A Preference Shares are outstanding, the Company cannot, without the approval~~ of ~~the holders of seventy-five percent (75%) of the then outstanding Series A Preference Shares, alter or change adversely the powers, preferences or rights attaching~~March 31, 2021 and December 31, 2020. Refer to the ~~Series A Preference Shares or enter into any agreement with respect to~~Company’s Annual Report on Form 10-K for the ~~foregoing.~~

Holders of the Series A Preference Shares are entitled to receive, and the Company is required to pay, dividends (other than dividends in the form of ordinary shares) on the Series A Preference Shares equal (on an as-if-converted-to-ordinary-shares basis) to and in the same form as dividends (other than dividends in the form of ordinary shares) actually paid on ordinary shares when, as and if such dividends (other than dividends in the form of ordinary shares) are paid on the ordinary shares.

~~The restricted American Depositary Shares and Series A Preference Shares were sold in~~year ended December 31, 2020 for a transaction exempt from the registration requirements under the Securities Act of 1933, as amended, or the Securities Act. The Company filed a registration statement with the SEC covering the resale of the restricted American Depositary Shares and the ADSs representing ordinary shares created by the consolidation and redesignation of the Series A Preference Shares, or the Registrable Securities, on April 9, 2015, which was declared effective by the SEC on May 1, 2015. In addition, the Company agreed to use its commercially reasonable best efforts to keep the registration, and any qualification, exemption or compliance under state securities laws which the Company determines to obtain, continuously effective, and to keep the Registration Statement free of any material misstatements or omissions, until the earlier of (a) March 11, 2017 or (b) the date on which all Registrable Securities held by Purchasers may be sold or transferred in compliance with Rule 144 under the Securities Act, without any volume or manner of sale restrictions.

During April 2020, at the request of certain holders, 237,713,680 Series A Preference Shares were consolidated and redesignated, resulting in the issuance of 23,771,368 ordinary shares. As of June 30, 2020, a total of 300,547,010 Series A Preference Shares had been consolidated and redesignated at the request of holders, resulting in the issuance of 30,054,701 ADSs, such that a maximum of 5,160,378 ordinary shares remained issuable upon future consolidation and redesignation of the remaining Series A Preference Shares as of June 30, 2020, subject to certain adjustments for dilutive events.

During July 2020, at the request of certain holders, 27,753,000 Series A Preference Shares were consolidated and redesignated, resulting in the issuance of 2,775,300 ordinary shares. Following this consolidation and redesignation of these shares in July 2020, a maximum of 2,385,078 ordinary shares remain issuable upon future consolidation and redesignation of the remaining Series A Preference Shares, subject to certain adjustments for dilutive events.more complete background.

~~On March 16, 2020,~~There was no common stock activity during the Company’s Board of Directors, upon the recommendation of the Remuneration Committee and based on input from Radford, part of the Rewards Solutions practice of Aon Plc, as independent external compensation consultants to the Company’s Remuneration Committee, adopted, subject to shareholder approval, the Amarin Corporation plc 2020 Stock Incentive Plan, or the 2020 Plan, which was subsequently approved by the Company’s shareholders on July 13, 2020 at the Annual General Meeting of Shareholders. The 2020 Plan is intended to be the successor to the Amarin Corporation plc 2011 Stock Option Plan, as amended, or the 2011 Plan, which was set to expire on July 12, 2021. The maximum number of the Company’s ordinary shares of £0.50 each or equivalent ADSs to be issued under the 2020 Plan shall not exceed the sum of (i) 20,000,000 shares and (ii) the number

of shares that remain available for grant under the 2011 Plan as of the date the 2020 Plan is approved by the Company’s shareholders. The number of shares remaining under the 2011 Plan is approximately 2,634,440. The award of stock options (both incentive and non-qualified stock options), restricted stock units, and certain limited unrestricted share awards are permitted. The 2020 Plan will be administered by the Remuneration Committee of the Board of Directors and will expire on July 13, 2030.

~~During the six~~three months ended ~~June 30,~~March 31, 2021 and 2020 ~~and 2019, in addition to ordinary shares issued~~ except as described in ~~Preferred Stock~~ ~~above and~~ in Incentive Equity Awards ~~below, the Company issued 123,608 and 47,358 ordinary shares, respectively, under the Amarin Corporation plc 2017 Employee Stock Purchase Plan.~~below.

As of ~~June 30, 2020,~~March 31, 2021, there were an aggregate of ~~17,177,729~~19,371,777 stock options and ~~7,571,974~~10,251,564 restricted stock units, or RSUs, outstanding, ~~under the 2011 Plan~~ representing approximately 4%5% and 2%, respectively, of outstanding shares ~~(including common and preferred shares)~~ on a fully diluted basis.

During the ~~six~~three months ended ~~June 30,~~March 31, 2021 and 2020, ~~and 2019,~~ the Company issued ~~560,755~~783,320 and ~~4,458,143~~412,465 common shares, respectively, as a result of the exercise of stock options, resulting in gross and net proceeds of ~~$1.7~~$2.1 million during the ~~six~~three months ended ~~June 30, 2020~~March 31, 2021 and $~~17.4~~$1.3 million during the ~~six~~three months ended ~~June 30, 2019.~~

March 31, 2020. During the ~~six~~three months ended ~~June 30,~~March 31, 2021 and 2020, ~~and 2019,~~ the Company issued ~~1,143,934~~940,977 and ~~1,533,061~~1,109,600 common shares, respectively, related to the vesting of RSUs, of which ~~418,847~~365,463 and ~~580,765~~406,042 shares, respectively, were retained as treasury shares as settlement of employee tax obligations. During the ~~six~~three months ended ~~June 30,~~March 31, 2021 and 2020, in connection with the achievement of certain regulatory and sales performance conditions associated with the REDUCE-IT clinical trial and subsequent revenue growth, the Company issued ~~974,754~~1,506,428 and 841,848 common shares, respectively, upon vesting of performance-based RSUs granted in 2017 and 2018, of which ~~411,956~~638,502 and 353,790 shares, respectively, were retained as treasury shares as settlement of employee tax obligations. These performance-based RSUs will continue to vest ratably monthly through August 2021.

On ~~June 1, 2020,~~January 4, 2021, the Company granted a total of ~~782,520~~3,265,700 RSUs and 3,100,200 stock options to employees under the ~~2011~~Amarin Corporation plc 2020 Stock Incentive Plan, or the 2020 Plan. The RSUs vest ~~quarterly~~annually over a three-year ~~period.~~period and the stock options vest quarterly over a four-year period with a one-year cliff vesting. Also on January 4, 2021, the Company granted a total of 1,345,800 RSUs to certain employees under the 2020 Plan that vest upon the achievement of specified operational performance conditions.

On March 2, 2020 and February 3, 2020, the Company granted a total of 821,950 RSUs and 1,875,000 stock options, respectively, to employees under the Amarin Corporation plc 2011 Stock Incentive Plan, or the 2011 Plan. The RSUs vest annually over a three-year period and the stock options vest quarterly over a four-year period.Also on February 3, 2020, the Company granted a total of 1,253,400 RSUs to employees under the 2011 Plan that vest upon the achievement of specified sales performance conditions.

~~On May 20, 2019, the Company granted a total of 45,163 RSUs and 58,721 stock options to members of the Company’s Board of Directors under the 2011 Plan. The RSUs vest in equal installments over a~~ ~~three-year~~ period upon the earlier of the anniversary of the grant date or the Company’s annual general meeting of shareholders in such anniversary year. The stock options vest in full upon the earlier of the one-year anniversary of the grant date or the Company’s annual general meeting of shareholders in such anniversary year. Upon termination of service to the Company or upon a change of control, each director shall be entitled to a payment equal to the fair market value of one share of Amarin common stock per award vested or granted, respectively, which is required to be made in shares.

~~Also on May 20, 2019, the Company granted an additional 20,000 RSUs to employees under the 2011 Plan that vest upon the achievement of a specified sales performance condition.~~

~~On February 1, 2019, the Company granted a total of 757,800 RSUs and 1,193,400 stock options to employees under the 2011 Plan. The RSUs vest annually over a~~ ~~three-year~~ ~~period and the stock options vest quarterly over a~~ ~~four-year~~ ~~period. Also on February 1, 2019, the Company granted a total of 580,000 RSUs to employees under the 2011 Plan that vest upon the achievement of a specified sales performance condition.~~

On March 31, 2014, the Company entered into a Co-Promotion Agreement, or the Agreement, with Kowa Pharmaceuticals America, Inc. related to the commercialization of VASCEPA capsules in the United States. Under the terms of the Agreement, the Company granted to Kowa Pharmaceuticals America, Inc. the right to be the sole co-promoter, together with the Company, of VASCEPA in the United States during the term. The Agreement was amended on July 25, 2017 to reflect evolving promotional needs, including refinement of target lists. The Company and Kowa Pharmaceuticals America, Inc. intentionally designed the ~~co-promotion~~Agreement to naturally end as of December 31, 2018 and mutually agreed not to renew the ~~agreement.~~Agreement.

During 2018, which was the last year of the ~~Agreement, as amended,~~co-promotion of VASCEPA by Kowa Pharmaceuticals America, Inc., the Company incurred expense for co-promotion tail payments which are calculated as a percentage of the 2018 co-promotion fee, which was eighteen and a half percent (18.5%) of VASCEPA gross ~~margin.~~margin in 2018. The accrued tail payments are paid over three years with

declining amounts each year. Kowa Pharmaceuticals America, Inc. iswas eligible to receive $17.8 million in co-promotion tail payments, the present value of which $16.6 million, was fully accrued as of December 31, 2018.

As of ~~June 30, 2020 and December~~March 31, ~~2019,~~2021, a net payable to Kowa Pharmaceuticals America, Inc. of ~~$6.5~~$2.5 million ~~and $10.0 million, respectively, of which $4.6 million and $6.5 million, respectively,~~ was classified as current on the condensed consolidated balance ~~sheets,~~sheet, representing the remaining accrued co-promotion ~~fees, including accrual~~tail payments. As of December 31, 2020, a net payable to Kowa Pharmaceuticals America, Inc. of $3.8 million, of which $3.2 million was classified as current on the condensed consolidated balance sheet, represents the remaining accrued co-promotion tail ~~payments, net of reimbursable amounts incurred for samples and other marketing expenses~~payments..

The Company sells VASCEPA principally to a limited number of major wholesalers, as well as selected regional wholesalers and specialty pharmacy providers in the United States, or collectively, its distributors or its customers, that in turn resell VASCEPA to retail pharmacies for subsequent resale to patients and healthcare providers. Patients are required to have a prescription in order to purchase VASCEPA. In addition to distribution agreements with distributors, the Company enters into arrangements with health care providers and payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks and discounts with respect to the purchase of the Company’s product.

Revenues from product sales are recognized when the distributor obtains control of the Company’s product, which occurs at a point in time, typically upon delivery to the distributor. Payments from distributors are generally received 30-60 days from the date of sale. The Company evaluates the creditworthiness of each of its distributors to determine whether revenues can be recognized upon delivery, subject to satisfaction of the other requirements, or whether recognition is required to be delayed until receipt of payment. The Company calculates gross product revenues generally based on the wholesale acquisition cost that the Company charges its distributors for VASCEPA.

Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established and which result from (a) trade allowances, such as invoice discounts for prompt pay and distributor fees, (b) estimated government and private payor rebates and chargebacks and discounts, such as Medicaid reimbursements, (c) reserves for expected product returns and (d) estimated costs of incentives that are offered within contracts between the Company and its distributors, health care providers, payors and other indirect customers relating to the Company’s sales of its product. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the distributor) or as a current liability (if the amount is payable to a party other than a distributor). Where appropriate, these estimates take into consideration a range of possible outcomes which are probability-weighted for relevant factors such as the Company’s historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the contract. The amount of variable consideration which is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known.

Trade Allowances: The Company generally provides invoice discounts on VASCEPA sales to its distributors for prompt payment and fees for distribution services, such as fees for certain data that distributors provide to the Company. The payment terms for sales to distributors generally include a 2% discount for prompt payment while the fees for distribution services are based on contractual rates agreed with the respective distributors. Based on historical data, the Company expects its distributors to earn these discounts and fees, and deducts the full amount of these discounts and fees from its gross product revenues and accounts receivable at the time such revenues are recognized.

Rebates, Chargebacks and Discounts: The Company contracts with Medicaid, Medicare, other government agencies and various private organizations, or collectively, Third-party Payors, so that VASCEPA will be eligible for purchase by, or partial or full reimbursement from, such Third-party Payors. The Company estimates the rebates, chargebacks and discounts it will provide to Third-party Payors and deducts these estimated amounts from its gross product revenues at the time the revenues are recognized. The Company estimates these reserves based upon a range of possible outcomes that are probability-weighted for the estimated payor mix. These reserves are recorded in the same period the revenue is recognized, resulting in a reduction of

product revenue and the establishment of a current liability, which is included in ~~accrued~~Accrued expenses and other current liabilities on the condensed consolidated balance sheets. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. The Company estimates the rebates, chargebacks and discounts that it will provide to Third-party Payors based upon (i) the Company’s contracts with these Third-party Payors, (ii) the government-mandated discounts applicable to government-funded programs, (iii) information obtained from the Company’s distributors and (iv) information obtained from other third parties

regarding the payor mix for VASCEPA. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period.

Product Returns: The Company’s distributors have the right to return unopened unprescribed VASCEPA during the 18-month period beginning six months prior to the labeled expiration date and ending twelve months after the labeled expiration date. The expiration date for VASCEPA 1-gram and 0.5-gram size capsules is currently four years and three years, respectively, after being converted into capsule form, which is the last step in the manufacturing process for VASCEPA and generally occurs within a few months before VASCEPA is delivered to distributors. The Company estimates future product returns on sales of VASCEPA based on: (i) data provided to the Company by its distributors (including weekly reporting of distributors’ sales and inventory held by distributors that provided the Company with visibility into the distribution channel in order to determine what quantities were sold to retail pharmacies and other providers), (ii) information provided to the Company from retail pharmacies, (iii) data provided to the Company by a third-party data provider which collects and publishes prescription data, and other third parties, (iv) historical industry information regarding return rates for similar pharmaceutical products, (v) the estimated remaining shelf life of VASCEPA previously shipped and currently being shipped to distributors and (vi) contractual agreements intended to limit the amount of inventory maintained by the Company’s distributors. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in ~~accrued~~Accrued expenses and other current liabilities on the condensed consolidated balance sheets.

Other Incentives: Other incentives that the Company offers to indirect customers include co-pay mitigation rebates provided by the Company to commercially insured patients who have coverage for VASCEPA and who reside in states that permit co-pay mitigation programs. The Company’s co-pay mitigation program is intended to reduce each participating patient’s portion of the financial responsibility for VASCEPA’s purchase price to a specified dollar amount. Based upon the terms of the program and information regarding programs provided for similar specialty pharmaceutical products, the Company estimates the average co-pay mitigation amounts and the percentage of patients that it expects to participate in the program in order to establish its accruals for co-pay mitigation rebates. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in ~~accrued~~Accrued expenses and other current liabilities on the condensed consolidated balance sheets. The Company adjusts its accruals for co-pay mitigation rebates based on actual redemption activity and estimates regarding the portion of issued co-pay mitigation rebates that it estimates will be redeemed.

The following tables summarize activity in each of the net product revenue allowance and reserve categories described above for the ~~six~~three months ended ~~June 30, 2020~~March 31, 2021 and ~~2019:~~2020:

In thousands	Trade Allowances			Rebates, Chargebacks and Discounts			Product Returns			Other Incentives			Total			Trade Allowances			Rebates, Chargebacks and Discounts			Product Returns			Other Incentives			Total
Balance as of December 31, 2019	$	29,261		$	90,997		$	4,579		$	3,720		$	128,557
Balance as of December 31, 2020																$	36,242		$	141,201		$	7,797		$	5,587		$	190,827
Provision related to current period sales		59,829			266,823			1,589			33,743			361,984			29,134			148,241			828			13,122			191,325
Provision related to prior period sales		—			(3,872	)		—			—			(3,872	)		—			(854	)		—			—			(854	)
Credits/payments made for current period sales		(23,197	)		(152,965	)		—			(29,897	)		(206,059	)		(3,582	)		(16,136	)		—			(9,807	)		(29,525	)
Credits/payments made for prior period sales		(29,067	)		(85,622	)		(191	)		(3,721	)		(118,601	)		(7,086	)		(108,020	)		(402	)		(5,618	)		(121,126	)
Balance as of June 30, 2020	$	36,826		$	115,361		$	5,977		$	3,845		$	162,009
Balance as of March 31, 2021																$	54,708		$	164,432		$	8,223		$	3,284		$	230,647

In thousands	Trade Allowances			Rebates, Chargebacks and Discounts			Product Returns			Other Incentives			Total			Trade Allowances			Rebates, Chargebacks and Discounts			Product Returns			Other Incentives			Total
Balance as of December 31, 2018	$	19,495		$	41,634		$	2,948		$	1,167		$	65,244
Balance as of December 31, 2019																$	29,261		$	90,997		$	4,579		$	3,720		$	128,557
Provision related to current period sales		37,545			164,871			987			18,625			222,028			30,640			133,721			815			18,528			183,704
Provision related to prior period sales		—			—			—			—			—			—			(3,209	)		—			—			(3,209	)
Credits/payments made for current period sales		(19,203	)		(98,452	)		5			(16,687	)		(134,337	)		(6,872	)		(33,927	)		—			(10,820	)		(51,619	)
Credits/payments made for prior period sales		(19,325	)		(41,363	)		(471	)		(1,199	)		(62,358	)		(29,047	)		(75,738	)		(145	)		(3,721	)		(108,651	)
Balance as of June 30, 2019	$	18,512		$	66,690		$	3,469		$	1,906		$	90,577
Balance as of March 31, 2020																$	23,982		$	111,844		$	5,249		$	7,707		$	148,782

Such net product revenue allowances and reserves are included within ~~accrued~~Accrued expenses and other current liabilities within the condensed consolidated balance sheets, with the exception of trade allowances and chargebacks, which are included within ~~accounts~~Accounts receivable, net as discussed below.

The Company enters into licensing agreements which are within the scope of Topic 606,, under which it licenses certain rights to VASCEPA for uses that are currently commercialized and under development by the Company. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; payments for manufacturing supply services the Company provides through its contract manufacturers; and royalties on net sales of licensed products. Each of these payments results in licensing revenues.

In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation.

In determining performance obligations, management evaluates whether the license is distinct from the other performance obligations with the collaborative partner based on the consideration of the relevant facts and circumstances for each arrangement. Factors considered in the determination include the stage of development of the license delivered, research and development capabilities of the partner and the ability of partners to develop and commercialize VASCEPA independent of the Company.

Licenses of intellectual property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.

Milestone Payments: At the inception of each arrangement that includes development, regulatory and commercial milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The Company evaluates factors such as the scientific, clinical, regulatory, commercial and other risks that must be overcome to achieve the respective milestone as well as the level of effort and investment required. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development, regulatory and commercial milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect licensing revenues and earnings in the period of adjustment.

The Company receives payments from its customers based on billing schedules established in each contract. Up-front payments and fees are recorded as deferred revenue upon receipt or when due, and may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less.

In June 2018, the Company entered into a collaboration with ~~Mochida Pharmaceutical Co., Ltd., or~~ Mochida related to the development and commercialization of drug products and indications based on the active pharmaceutical ingredient in VASCEPA, the omega-3 acid, EPA, or eicosapentaenoic acid. Among other terms in the agreement, the Company obtained an exclusive license to certain Mochida intellectual property to advance the Company’s interests in the United States and certain other territories and the

parties will collaborate to research and develop new products and indications based on EPA for the Company’s commercialization in the United States and certain other territories. The potential new product and indication opportunities contemplated under this agreement are currently in early stages of development.

Upon closing of the collaboration agreement, the Company made a non-refundable, non-creditable upfront payment of approximately $2.7 million. In addition, the agreement provides for the Company to pay milestone payments upon the achievement of certain product development milestones and royalties on net sales of future products arising from the collaboration, if any.

In January ~~2020, we achieved~~2021, the Company exercised certain ~~milestones~~rights under the agreement, resulting in a payment of $1.0 million to Mochida, which was recorded as Research and development expense onin the condensed consolidated statement of operations. In January 2020 and December 2020, the Company exercised certain rights under the agreement, resulting in payments of $1.0 million, respectively, to Mochida, which were recorded as Research and development expense in the condensed consolidated statement of operations.

In February 2015, the Company entered into a Development, Commercialization and Supply Agreement, or the DCS Agreement, with Eddingpharm (Asia) Macao Commercial Offshore Limited, or ~~Eddingpharm,~~Edding, related to the development and commercialization of VASCEPA in Mainland China, Hong Kong, Macau and Taiwan, or the China Territory. Under the terms of the DCS Agreement, the Company granted to ~~Eddingpharm~~Edding an exclusive (including as to the Company) license with right to sublicense to develop and commercialize VASCEPA in the China Territory for uses that are currently commercialized and under development by the Company based on the Company’s MARINE, ANCHOR and REDUCE-IT clinical trials of VASCEPA.

Under the DCS Agreement, ~~Eddingpharm~~Edding is solely responsible for development and commercialization activities in the China Territory and associated expenses. The Company provides development assistance and is responsible for supplying finished and later bulk drug product at defined prices under negotiated terms. The Company retains all VASCEPA manufacturing rights. ~~Eddingpharm~~Edding agreed to certain restrictions regarding the commercialization of competitive products globally and the Company agreed to certain restrictions regarding the commercialization of competitive products in the China Territory.

The Company and ~~Eddingpharm~~Edding agreed to form a joint development committee to oversee regulatory and development activities for VASCEPA in the China Territory in accordance with a negotiated development plan and to form a separate joint commercialization committee one year prior to expected approval in the China Territory to oversee VASCEPA planning and pre-launch commercialization activities in the China Territory. Development costs are paid by ~~Eddingpharm~~Edding to the extent such costs are incurred in connection with the negotiated development plan or otherwise incurred by ~~Eddingpharm. Eddingpharm~~Edding. Edding is responsible for preparing and filing regulatory applications in all countries of the China Territory at ~~Eddingpharm’s~~Edding’s cost with the Company’s assistance. The DCS Agreement also contains customary provisions regarding indemnification, supply, record keeping, audit rights, reporting obligations, and representations and warranties that are customary for an arrangement of this type.

The term of the DCS Agreement expires, on a product-by-product basis, upon the later of (i) the date on which such product is no longer covered by a valid claim under a licensed patent in the China Territory, or (ii) the twelfth (12th) anniversary of the first commercial sale of such product in Mainland China. The DCS Agreement may be terminated by either party in the event of a bankruptcy of the other party and for material breach, subject to customary cure periods. In addition, at any time following the third anniversary of the first commercial sale of a product in Mainland China, ~~Eddingpharm~~Edding has the right to terminate the DCS Agreement for convenience with twelve months’ prior notice. Neither party may assign or transfer the DCS Agreement without the prior consent of the other party, provided that the Company may assign the DCS Agreement in the event of a change of control transaction.

Upon closing of the DCS Agreement, the Company received a non-refundable $15.0 million up-front payment. In March 2016, ~~Eddingpharm~~Edding submitted its clinical trial application, or CTA, with respect to the MARINE indication for VASCEPA to the Chinese regulatory authority. Following the CTA submission, the Company received a non-refundable $1.0 million milestone payment. In March 2017, the CTA was approved by the Chinese regulatory authority, and, in December 2017, ~~Eddingpharm~~Edding commenced a pivotal clinical trial aimed to support the regulatory approval of the first indication of VASCEPA in a patient population with severe hypertriglyceridemia in Mainland China. In November 2020, the Company announced statistically significant topline results from the Phase 3 clinical trial of VASCEPA conducted by Edding, which is being used to seek regulatory approval in Mainland China.

In addition to the non-refundable, up-front and regulatory milestone payments described above, the Company is entitled to receive certain regulatory and sales-based milestone payments of up to an additional $153.0 million as well as tiered double-digit percentage royalties on net sales of VASCEPA in the China Territory escalating to the high teens. The regulatory milestone events relate to the submission and approval of certain applications to the applicable regulatory authority, such as a clinical trial application, clinical trial exemption, or import drug license application. The amounts to be received upon achievement of the regulatory milestone events relate to the submission and approval for 3 indications, and range from $2.0 million to $15.0 million for a total of $33.0 million. The sales-based milestone events occur when annual aggregate net sales of VASCEPA in the territory equals or exceeds certain specified thresholds, and range from $5.0 million to $50.0 million for a total of $120.0 million. Each such milestone payment shall be payable

only once regardless of how many times the sales milestone event is achieved. Each such milestone payment is non-refundable and non-creditable against any other milestone payments.

The Company assessed this arrangement in accordance with Topic 606 and concluded that the contract counterparty, ~~Eddingpharm,~~Edding, is a customer. The Company identified the following performance obligations at the inception of the DCS Agreement: (1) the exclusive license to develop and commercialize VASCEPA in the China Territory for uses that are currently commercialized and under development by the Company, (2) the obligation to participate in various steering committees, and (3) ongoing development and regulatory assistance. Based on the analysis performed, the Company concluded that the identified performance obligations are not distinct and therefore a combined performance obligation.

The transaction price includes the $15.0 million up-front consideration received and the $1.0 million milestone payment received related to the successful submission of the CTA for the MARINE indication. None of the other clinical or regulatory milestones have been included in the transaction price, as all milestone amounts are fully constrained. As part of its evaluation of the constraint, the Company considered numerous factors, including that receipt of the milestones is outside the control of the Company and contingent upon success in future clinical trials and the licensee’s efforts. Any consideration related to sales-based milestones (including royalties) will be recognized when the related sales occur and therefore have also been excluded from the transaction price. The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

During the ~~six~~three months ended ~~June 30,~~March 31, 2021 and 2020, ~~and 2019,~~ the Company recognized ~~$1.6~~$0.3 million and ~~less than $0.1~~$0.6 million, respectively, as licensing revenue related to the up-front and milestone payments received in connection with the ~~Eddingpharm~~Edding agreement. From contract inception through ~~June 30, 2020~~March 31, 2021 and December 31, ~~2019,~~2020, the Company recognized ~~$4.6~~$6.4 million and ~~$3.0~~$6.1 million, respectively, as licensing revenue under the DCS Agreement concurrent with the input measure of support hours provided by Amarin to ~~Eddingpharm~~Edding in achieving the combined development and regulatory performance obligation, which in the Company’s judgment is the best measure of progress towards satisfying this performance obligation. The remaining transaction price of ~~$11.3~~$10.5 million and ~~$13.0~~$10.8 million is recorded in deferred revenue as of ~~June 30, 2020~~March 31, 2021 and December 31, ~~2019,~~2020, respectively, on the condensed consolidated balance sheets and will be recognized as revenue over the remaining period of 1413 years.

In March 2016, the Company entered into an agreement with Biologix FZCo, or Biologix, a company incorporated under the laws of the United Arab Emirates, to register and commercialize VASCEPA in several Middle Eastern and North African countries. Under the terms of the distribution agreement, the Company granted to Biologix a non-exclusive license to use its trademarks in connection with the importation, distribution, promotion, marketing and sale of VASCEPA in the Middle East and North Africa territory. Upon closing of the agreement, the Company received a non-refundable up-front payment, which will be recognized as revenue over 10 years commencing upon first marketing approval of VASCEPA in the territory. The Company is entitled to receive all payments based on total product sales and pays Biologix a service fee in exchange for its services, whereby the service fee represents a percentage of gross selling price which is subject to a minimum floor price.

~~In March 2018 and July 2018, the~~The Company received approval ~~for~~of VASCEPA as a prescription medication for use in Lebanon ~~and~~in March 2018, in United Arab Emirates ~~respectively,~~in July 2018, in Qatar in January 2020 and in Bahrain in December 2020 as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. VASCEPA was launched in Lebanon in June 2018 and in United Arab Emirates in February ~~2019, respectively.~~2019.

The Company recognized net product revenue of approximately $0.5 million and nil as of March 31, 2021 and ~~$0.3 million for the six months ended June 30,~~ 2020, ~~and 2019, respectively.~~respectively, related to sales to Biologix.

In September 2017, the Company entered into an agreement with HLS Therapeutics Inc., or HLS, a company incorporated under the laws of Canada, to register, commercialize and distribute VASCEPA in Canada. Under the agreement, HLS iswill be responsible for regulatory and commercialization activities and associated costs. The Company is responsible for providing assistance towards local filings, supplying finished product under negotiated supply terms, maintaining intellectual property, and continuing the development and funding of REDUCE-IT related activities.

Upon closing of the agreement, the Company received one-half of a non-refundable $5.0 million up-front payment, and received the remaining half on the six-month anniversary of the closing. Following achievement of the REDUCE-IT trial primary endpoint, which was announced in September 2018, the Company received a non-refundable $2.5 million milestone payment. Following approval from Health Canada in December 2019, the Company received a non-refundable milestone payment of $2.5 million in February 2020. In addition, in January 2020 HLS obtained regulatory exclusivity from the Office of Patented Medicines and Liaison, or OPML, as a result the Company received a non-refundable $3.8 million milestone payment. In addition to the non-refundable, up-front and regulatory milestone payments just described, the Company is entitled to receive certain sales-based milestone payments of up to an additional $50.0 million, as well as tiered double-digit royalties on net sales of VASCEPA in Canada.

The Company assessed this arrangement in accordance with Topic 606 and concluded that the contract counterparty, HLS, is a customer. The Company identified the following performance obligations at the inception of the contract: (1) license to HLS to develop, register, and commercialize VASCEPA in Canada, (2) support general development and regulatory activities, and (3) participate in various steering committees. Based on the analysis performed, the Company concluded that the identified performance obligations in the agreement are not distinct and therefore a combined performance obligation.

The transaction price includes the $5.0 million up-front consideration, the $2.5 million milestone related to the achievement of the REDUCE-IT trial primary endpoint, the $2.5 million milestone related to obtaining approval from Health Canada and $3.8 million milestone related to obtaining regulatory exclusivity from the OPML. Any consideration related to sales-based milestones (including royalties) will be recognized when the related sales occur and therefore have also been excluded from the transaction price. The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

During the ~~six~~three months ended ~~June 30,~~March 31, 2021 and 2020, ~~and 2019,~~ the Company recognized ~~$2.7~~$0.3 million and ~~$0.8~~$2.2 million, respectively, as licensing revenue related to up-front and milestone payments received in connection with the HLS agreement. From the contract’s inception through ~~June 30, 2020~~March 31, 2021 and December 31, ~~2019,~~2020, the Company has recognized ~~$5.6~~$6.9 million and ~~$2.9~~$6.6 million, respectively, as licensing revenue is recognized under the agreement concurrent with the input measure of support hours provided by Amarin to HLS in achieving this performance obligation, which in the Company’s judgment is the best measure of progress towards satisfying the combined development and regulatory performance obligation. The remaining transaction price of ~~$8.1~~$6.8 million and $7.1 million is recorded in deferred revenue as of ~~June 30, 2020~~March 31, 2021 and December 31, ~~2019,~~2020, respectively, on the condensed consolidated balance sheets and will be recognized as revenue over the remaining period of 109 years.

The Company recognized net product revenue of ~~$1.8~~nil and $6.7 million as of March 31, 2021 and ~~nil for the three months ended June 30,~~ 2020, ~~and 2019,~~ respectively, ~~and $8.5 million and nil for the six months ended June 30, 2020 and 2019, respectively.~~related to HLS.

The following table presents changes in the balances of the Company’s contract assets and liabilities during the ~~six~~three months ended ~~June 30, 2020 and 2019:~~

In thousands	Balance at Beginning of Period		Additions		Deductions			Balance at End of Period		Balance at Beginning of Period		Additions		Deductions			Balance at End of Period
Six months ended June 30, 2020:
Three months ended March 31, 2021:
Contract assets	$	—	$	—	$	—		$	—	$	—	$	—	$	—		$	—
Contract liabilities:
Deferred revenue	$	20,846	$	3,750	$	(4,382	)	$	20,213	$	18,632	$	—	$	(662	)	$	17,970

Six months ended June 30, 2019:
Three months ended March 31, 2020:
Contract assets	$	—	$	—	$	—		$	—	$	—	$	—	$	—		$	—
Contract liabilities:
Deferred revenue	$	20,710	$	—	$	(973	)	$	19,737	$	20,846	$	3,750	$	(2,789	)	$	21,807

During the ~~six~~three months ended ~~June 30, 2020 and 2019 date,~~March 31, 2021, the Company recognized the following revenues as a result of changes in the contract asset and contract liability balances in the respective periods:

The Company leases office space under operating leases. The lease liability is initially measured at the present value of the lease payments to be made over the lease term. Lease payments are comprised of the fixed and variable payments to be made by the Company to the lessor during the lease term minus any incentives or rebates or abatements receivable by the Company from the lessor or the owner. Payments for non-lease components do not form part of lease payments. The lease term includes renewal options only if these options are specified in the lease agreement and if failure to exercise the renewal option imposes a significant economic penalty for the Company. As there are no significant economic penalties, renewal cannot be reasonably assured and the lease terms for the office space do not include any renewal options. The Company has not entered into any leases with related parties. The Company accounts for short-term leases (i.e., lease term of 12 months or less) by making the short-term lease policy election and will not apply the recognition and measurement requirements of ASC 842.

The Company has determined that the rate implicit in the lease is not determinable and the Company does not have borrowings with similar terms and collateral. Therefore, the Company considered a variety of factors, including the Company’s credit rating, observable debt yields from comparable companies with a similar credit profile and the volatility in the debt market for securities with similar terms, in determining that 11.5% was reasonable to use as the incremental borrowing rate for purposes of the calculation of lease liabilities and a change of 1% would not result in a material change to the Company’s condensed consolidated financial statements.

On April 12, 2019 the Company entered into an Office Centre Sharing Agreement for office space in Dublin, Ireland effective May 1, 2019 was scheduled to terminate on April 30, 2020 and was extended for one additional year through April 30, 2021 and can continue to be extended automatically for successive one year periods. On July 4, 2019, the Company entered into an Office Centre Sharing Agreements effective October 1, 2019 for office space in Dublin, Ireland which terminates on September 30, 2020 and can be extended automatically for successive one year periods. These leases have been determined to be short-term leases and the Company is committed to making payments of $0.1 million during the next twelve months.

On February 5, 2019, the Company entered into a lease agreement for new office space in Bridgewater, New Jersey, or the Lease. The Lease commenced on August 15, 2019, or the Commencement Date, for an 11-year period, with 2 five-year renewal options. Subject to the terms of the Lease, Amarin will have a one-time option to terminate the agreement effective on the first day of the ninety-seventh month after the Commencement Date upon advance written notice and a termination payment specified in the Lease. Under the Lease, the Company pays monthly rent of approximately $0.1 million for the first year following the Commencement Date, and such rent will increase by a nominal percentage every year following the first anniversary of the Commencement Date. In addition, Amarin receives certain abatements subject to the limitations in the Lease. The operating lease liability is ~~$10.4~~$10.6 million and ~~$9.8~~$10.6 million and the operating lease right-of-use asset is ~~$8.3~~$8.0 million and ~~$8.5~~$8.1 million, as of ~~June 30, 2020~~March 31, 2021 and December 31, ~~2019,~~2020, respectively. The lease expense for the three ~~and six~~ months ended ~~June 30,~~March 31, 2021 and 2020 is approximately $0.4 million and ~~$0.8 million, respectively. The lease expense for the three and six months ended June 30, 2019 is approximately~~ $0.4 ~~million and $0.7~~ million, respectively.

The table below depicts a maturity analysis of the Company’s undiscounted payments for its operating lease liabilities and their reconciliation with the carrying amount of lease liability presented in the statement of financial position as of ~~June 30, 2020:~~March 31, 2021:

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements reflect our plans, estimates and beliefs. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “anticipates,” “believes,” “continue,” “could,” “estimates,��” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “would” and similar expressions intended to identify forward-looking statements. Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Because of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not transpire. We discuss many of these risks in Part I, Item 1A under the heading “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, ~~2019~~2020 and below under Part II, Item IA, “Risk Factors”.

Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent our estimates and assumptions only as of the date of this document. You should read this document with the understanding that our actual future results may be materially different from what we expect. Except as required by law, we do not undertake any obligation to publicly update or revise any forward-looking statements contained in this report, whether as a result of new information, future events or otherwise.

This Management’s Discussion and Analysis of Financial Condition and Results of Operations, or MD&A, should be read in conjunction with the Part I, Item 1, Business and Part II, Item 7, MD&A included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 for additional information on our business.

We are a pharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular, or CV, health and reduce CV risk.

Our lead product, VASCEPA^® (icosapent ethyl) was first approved by the ~~U.S.~~United States Food and Drug Administration, or U.S. FDA, for use as an adjunct to diet to reduce triglyceride, or TG, levels in adult patients with severe ~~(TG~~ ≥(≥500 mg/dL) hypertriglyceridemia. We launched VASCEPA in the United States, or U.S., in January 2013. On December 13, 2019 the ~~FDA-approved a new~~U.S. FDA approved an indication and label expansion for VASCEPA based on the landmark results of our cardiovascular outcomes trial of VASCEPA, ~~REDUCE-IT®~~REDUCE-IT^®, or Reduction of Cardiovascular Events with EPA – Intervention Trial. VASCEPA is the first and only drug approved by the U.S. FDA as an adjunct to maximally tolerated statin therapy for reducing persistent cardiovascular risk in select high risk-patients.

~~Since~~In August 2020, we announced our ~~inception,~~plans to launch icosapent ethyl under the brand name VAZKEPA, hereinafter along with the U.S. brand name VASCEPA, collectively referred to as VASCEPA, in major markets in Europe through our own new European sales and marketing teams. On January 28, 2021, the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, adopted a positive opinion, recommending that a marketing authorization be granted to our drug, icosapent ethyl, in the European Union, or EU, for the reduction of risk of cardiovascular events in patients with high cardiovascular risk. On March 26, 2021, the European Commission, or EC, granted approval of the marketing authorization application in the EU for VAZKEPA to reduce the risk of cardiovascular disease or diabetes and at least one additional cardiovascular risk factor. VAZKEPA is the first and only EC approved therapy to reduce cardiovascular risk in high-risk statin-treated patient. The EC approval provides ten years of market protection in the EU, and we have ~~devoted substantial resources~~been issued a patent that expires in 2033 with additional pending applications that could extend exclusivity into 2039. On April 22, 2021, we announced that we received marketing authorization from the Medicines and Healthcare Products Regulatory Agency, or MHRA, for VAZKEPA in England, Wales and Scotland to reduce cardiovascular risk through MHRA’s new ‘reliance’ route following the end of the BREXIT transition period.

In Europe, launch of VAZKEPA in individual countries is gated by timing of achieving product reimbursement on a country-by-country basis as is typical for new drugs. In seeking market access, we expect to file dossiers in ten European countries in the coming months, including the largest countries in Europe. Similar to our research and development efforts, most significantly our VASCEPA cardiovascular outcomes trial, REDUCE-IT. We announced topline results from REDUCE-IT on September 24, 2018. On November 10, 2018, we publicly presented primary results of the REDUCE-IT study at the 2018 Scientific Sessions of the American Heart Association, or AHA, and the results were concurrently publishedapproach in ~~The New England Journal of Medicine~~. REDUCE-IT met its primary endpoint demonstrating a 25% relative risk reduction, or RRR, to a high degree of statistical significance (p<0.001), in first occurrence of major adverse cardiovascular events, or MACE, in the intent-to-treat patient population with use of VASCEPA 4 grams/day as compared to placebo. REDUCE-IT also showed a 26% RRR in its key secondary composite endpoint of cardiovascular death, heart attacks and stroke (p<0.001). On March 18, 2019, we publicly presented the total cardiovascular events results, and the method of calculating such events, of the REDUCE-IT study at the American College of Cardiology’s, or ACC, 68^th ~~Annual Scientific Session and such results and methods were concurrently published in the~~ ~~Journal of the American College of Cardiology~~. Included in such results were that VASCEPA reduced total events (first and subsequent events) by 30% compared to placebo, reflecting that for every 1,000 patients treated for five years with VASCEPA versus placebo in this trial, approximately 159 MACE would have been prevented with VASCEPA.

~~Based on REDUCE-IT results, several clinical treatment guidelines and position statements have been updated, including those listed below:~~

In October 2019, the Institute for Clinical and Economic Review, or ICER, released its final evidence report regarding clinical effectiveness and economic impacts on VASCEPA. ICER’s report indicated that VASCEPA was cost effective across all of the non-profit organization’s analyses, including its quality-adjusted life year metrics of <$50,000. The conclusion from the report is that VASCEPA easily meets “commonly cited thresholds for cost-effectiveness and therefore represents a high long-term value for money” based on the organization’s value assessment framework. In addition, an independent academic, patient-level, cost-effectiveness analysis of icosapent ethyl led by Dr. William S. Weintraub, M.D., director of Outcomes Research with MedStar Cardiovascular Research Network, indicated that VASCEPA was projected to not only be cost-effective but also to reduce long-term health care costs in a majority of the scenarios analyzed.

~~The FDA granted Priority Review designation to our March 2019 supplemental new drug application, or sNDA, seeking an expanded indication for~~launching VASCEPA in the United States, in Europe we have been building a core team of experienced professionals and a highly capable sales team, who are involved with pre-launch planning and other commercial preparation activities and plan to leverage third-party relationships for various support activities. We also have commenced training sales representatives to advance pre-launch disease and brand awareness initiatives in preparation for the planned commercial launch of VAZKEPA in Germany before the end of Q3 2021. We expect to have approximately 150 sales representatives deployed for pre-launch product and disease state awareness programs by mid-Q2 2021 and approximately 300 professionals by the end of 2021.

In November 2020, we announced statistically significant topline results from the Phase 3 clinical trial of VASCEPA conducted by our partner in China. On February 9, 2021, we announced that our partner in China commenced the regulatory review processes in Mainland China and Hong Kong. The Chinese National Medical Products Administration, or NMPA, has accepted for review the new drug application for VASCEPA based on the ~~positive~~ results offrom the ~~REDUCE-IT study. The FDA grants Priority Review designation to applications for drugs that, if approved, have~~Phase 3 clinical trial and the potential to offer significant improvements in the effectiveness and safety of the treatment of serious conditions. In November 2019, FDA held an Endocrinologic and Metabolic Drugs Advisory Committee, or EMDAC, meeting to review the REDUCE-IT sNDA. The EMDAC voted unanimously (16-0) to recommend approval of an indication and label expansion for VASCEPA to reduce cardiovascular events in high-risk patients based on the REDUCE-IT results. On December 13, 2019, the FDA approved a new indication and label expansion for VASCEPA capsules. VASCEPA is the first and only drug approved by the FDA as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated TG levels (≥150 mg/dL) and either established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease.

~~On March 30, 2020, the United States District Court for the District of Nevada, or the Nevada Court, decided in favor of two generic companies in~~results from our ~~patent litigation related to their abbreviated new drug applications, or ANDAs, that seek FDA approval for sale of generic versions~~prior studies of VASCEPA. ~~On May 22, 2020, one~~We expect to receive a decision from the NMPA in Mainland China near the end of ~~the two generic companies, Hikma Pharmaceutical USA Inc., or Hikma, received FDA approval to market its generic version~~2021. The Hong Kong Department of ~~VASCEPA. To date, Hikma has not launched a generic version of VASCEPA.~~

~~We disagree with the Nevada Court’s decision that our patents are invalid and are vigorously pursuing an appeal. If generic companies determine to launch generic versions of icosapent ethyl~~Health is evaluating VASCEPA based initially on current approvals in the United States ~~such competition could have a material~~ and ~~adverse impact on our revenues and our operations.~~Canada with subsequent notification of the EC approval. The review process in Hong Kong is expected to conclude near the end of 2021.

~~VASCEPA is not yet known~~In addition to most healthcare professionals and generics companies rarely invest in product or disease state related market education. Furthermore, VASCEPA is relatively expensive to manufacture and already sold at an affordable price as documented by third-party analysis such that saving, if any, on the price of generic VASCEPA is likely to come at the expense of reduced market education and development. Thus, we believe that the launch of a generic version of VASCEPA in the United States at this early stage in the life cycle of VASCEPA is potentially harmful to patient care and discourages new product development, including identifying and pursuing additional indications that could be treated with VASCEPA.

~~Geographies outside the United States in which VASCEPA is sold and under regulatory review are not subject to this~~ U.S. ~~patent litigation and judgment. No similar litigation involving potential generic versions of VASCEPA is pending outside the United States.~~, VASCEPA is currently available by prescription in Canada, Lebanon and the United Arab Emirates. In Canada, VASCEPA has the benefit of eight years of data protection afforded through Health Canada (until the end of 2027), in addition to separate patent protection with expiration dates that could extend into 2039. ~~Amarin is pursuing additional regulatory approvals for VASCEPA in Europe, China and the Middle East.~~ In China and the Middle East, ~~Amarin is~~we are pursuing such regulatory approvals and subsequent commercialization of VASCEPA with commercial partners.

Based on REDUCE-IT results, to-date 15 clinical treatment guidelines or position statements from medical societies have been updated recommending the use of icosapent ethyl in at-risk patients. Based on our analysis of branded cardiovascular drugs in the United States which have positive cardiovascular outcomes studies, we believe the wholesale acquisition cost of VASCEPA is the lowest. In ~~Europe, Amarin is preparing to self-launch~~addition, while none of these other cardiovascular drugs compete directly with VASCEPA ~~although it may engage commercialization partners for certain~~and no head-to-head studies have been done between VASCEPA and these other drugs and the length and construct of the ~~smaller countries~~respective outcomes studies of ~~Europe. Ten~~these drugs vary, analysis of published clinical results from the cardiovascular outcomes studies of these drugs indicates that the number needed to ~~eleven years~~treat, or NNT, for VASCEPA is as low or lower than for these other branded cardiovascular drugs. NNT is a measure of ~~market protection~~how many patients need to be treated before one patient benefits from the therapy. For VASCEPA, in this analysis, the NNT was based on the 25% relative risk reduction demonstrated for the primary endpoint of the study, the NNT for which is ~~anticipated due~~21, as opposed to ~~regulatory exclusivity~~one fewer MACE on average per six patients treated over the five-year study period based on total events. The original pricing for VASCEPA in the ~~European Union subject~~United States was established prior to results of the REDUCE-IT cardiovascular outcomes study during a timeframe when VASCEPA was only approved for the original indication as an adjunct to diet to reduce TG levels in adult patients with severe (TG ≥500 mg/dL) hypertriglyceridemia. We believe that this relatively low price for VASCEPA in the United States, together with the demonstrated efficacy and safety of VASCEPA, will help lead to many at-risk patients being treated by VASCEPA.

On March 30, 2020, the United States District Court for the District of Nevada, or the Nevada Court, ruled in favor of two generic companies in our patent litigation related to their abbreviated new drug applications, or ANDAs, that sought U.S. FDA approval ~~recommendation~~for sale of generic versions of VASCEPA. On May 22, 2020 and August 10, 2020, the two generic companies, Hikma Pharmaceutical USA Inc., or Hikma, and Dr. Reddy’s Laboratories, Inc., or Dr. Reddy’s, received U.S. FDA approval to market its generic versions of VASCEPA for the original indication of VASCEPA as an adjunct to diet to reduce TG levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. On September 3, 2020, the U.S. Court of Appeals for the Federal Circuit upheld the March ruling by the ~~European Medicines Agency,~~Nevada Court in favor of the two generic companies. On October 2, 2020, we filed a combined petition for panel rehearing or ~~EMA, near~~rehearing en banc. On November 4, 2020, our rehearing and en banc petitions were denied. On February 11, 2021, we filed a petition for a writ of certiorari with the ~~end~~United States Supreme Court to ask the Court to hear our appeal in this litigation, which is pending. We intend to vigorously pursue this matter, but we cannot predict the outcome.

In November 2020, Hikma launched their generic version of VASCEPA on a limited scale. On November 30, 2020 we filed a patent infringement lawsuit against Hikma for making, selling, offering to sell and ~~associated European Community, or EC, approval expected promptly thereafter,~~importing generic icosapent ethyl capsules in and into the United States in a manner that we allege has induced the infringement of patents covering the use of VASCEPA to reduce specified cardiovascular risk. The earlier ANDA litigation did not pertain to our patents covering cardiovascular risk reduction. On January 25, 2021 we expanded the scope of the patent infringement lawsuit to include a health care insurance provider, Health Net, LLC.

We intend to vigorously pursue these ongoing litigation matters, but cannot predict the outcomes or the impact on our business. Geographies outside the United States in which VASCEPA is sold and under regulatory review are not subject to this U.S. patent litigation and judgment. No similar litigation involving potential generic version of VASCEPA is pending ~~patent protection~~outside the United States.

We are responsible for supplying VASCEPA to all markets in which the branded product is sold, including Canada, Lebanon and the United Arab Emirates where the drug is promoted and sold via collaborations with third-party companies that ~~could extend into 2039.~~compensate us for such supply. Subject to commercial launch in Europe and approval in China, we will be responsible for supplying products to those markets as well. We are not responsible for providing any generic company with drug product.

We commenced the commercial launch of VASCEPA ~~through sales and shipments to our network of U.S.-based wholesalers~~ in the United States in January ~~2013. We began selling and marketing~~2013 based on the original indication for VASCEPA. In October 2016, in addition to the original 1-gram capsule size for VASCEPA, ~~capsules in January 2013, and in October 2016,~~we introduced a smaller 0.5-gram capsule size. The U.S. FDA-approved dosing for VASCEPA continues to be 4 grams per day, and as expected, the majority of new and existing patients taking VASCEPA continue to be prescribed the 1-gram size VASCEPA capsule. VASCEPA is sold principally to a limited number of major wholesalers, as well as selected regional wholesalers and specialty

distributors or our customers, that in turn resell VASCEPA to retail pharmacies for subsequent resale to patients and healthcare providers.

Prior to results of the REDUCE-IT study, we did not have cardiovascular outcomes data regarding the clinical effect of VASCEPA and a substantial portion of our resources were being spent on the REDUCE-IT study. As a result, our commercialization of VASCEPA was somewhat limited.

Prior to the REDUCE-IT results topline announcement in September 2018, our direct sales force consisted of approximately 170 sales professionals, including sales representatives and their managers. Based on the positive REDUCE-IT results, in early 2019, we increased the size of our sales team to approximately 440 sales professionals, including approximately 400 sales representatives. As a result of the ~~FDA’s newly approved indication~~COVID-19 pandemic and ~~label expansion,~~the related social distancing, in March 2020, we suspended face-to-face interactions between our sales representatives and healthcare professionals. We resumed on a limited basis field-based, face-to-face interactions with healthcare providers beginning in June 2020. During the late part of the summer of 2020, substantially all of our field force personnel were able to resume some level of face-to-face customer interactions in a manner consistent with guidelines from local, state and government health officials in the United States. In the fourth quarter of 2020 and continuing into the first quarter of 2021, the impact of COVID-19 worsened in much of the United States, with some physicians again limiting access to face-to-face interactions with our field force personnel. Accordingly, in the United States, we have intentionally slowed the hiring of replacements for certain of our open positions which resulted from ordinary turnover. When we witness our sales representatives increasingly able to resume direct ~~sales force was expanded~~interactions with healthcare professionals, it is our intention to ~~approximately 900 sales professionals, including approximately 800 sales representatives.~~ fill a significant number of these positions, provided such replacements are then appropriate to meet our business needs, which we continually evaluate.

Based on monthly compilations of data provided by a third party, Symphony Health, the estimated number of normalized total VASCEPA prescriptions for the three months ended ~~June 30,~~March 31, 2021 and 2020 ~~and 2019~~ was approximately ~~1,090,000~~1,064,000 and ~~755,000,~~1,061,000, respectively. According to data from another third party, IQVIA, the estimated number of normalized total VASCEPA prescriptions for the three months ended ~~June 30,~~March 31, 2021 and 2020 ~~and 2019~~ was approximately ~~1,007,000~~989,000 and ~~683,000,~~955,000, respectively. Normalized total prescriptions represent the estimated total number of VASCEPA prescriptions dispensed to patients, calculated on a normalized basis (i.e., one month’s supply, or total capsules dispensed multiplied by the number of grams per capsule divided by 120 grams). Inventory levels at wholesalers tend to fluctuate based on seasonal factors, prescription trends and other factors. Such third-party sources also report that the number of patients visiting physicians remains well below pre-pandemic levels, with such reported decline being particularly pronounced in some areas of the country where there is greater awareness of VASCEPA, such as southern California. In addition, these sources report lower levels of patient visits during the three months ended March 31, 2021 in Texas and other parts of the United States which experienced severe weather and power outages.

Companies such as Symphony Health and IQVIA collect and report estimates of weekly, monthly, quarterly and annual prescription information. There is a limited amount of information available to such companies to determine the actual number of total prescriptions for prescription products like VASCEPA during such periods. Each vendor’s estimates utilize a proprietary projection methodology and are based on a combination of data received from pharmacies and other distributors, and historical data when actual data is unavailable. Their calculations of changes in prescription levels between periods can be significantly affected by lags in data reporting from various sources or by changes in pharmacies and other distributors providing data. Such methods can from time to time result in significant inaccuracies in information when ultimately compared with actual results. These inaccuracies have historically been most prevalent and pronounced during periods of time of inflections upward or downward in rates of use. Further, data for a single and limited period may not be representative of a trend or otherwise predictive of future results. Data reported by Symphony Health and IQVIA is rarely identical. As such, the resulting conclusions from such sources should be viewed with caution. We are not responsible for the accuracy of these companies’ information and ~~Amarin does~~we do not receive prescription data directly from retail pharmacies.

We recognize revenue from product sales when the distributor obtains control of our product, which occurs at a point in time, typically upon delivery to the distributor. Timing of shipments to wholesalers, as used for revenue recognition purposes, and timing of prescriptions as estimated by these third parties may differ from period to period. Although we believe these data are prepared on a period-to-period basis in a manner that is generally consistent and that such results can be generally indicative of current prescription trends, these data are based on estimates and should not be relied upon as definitive. While we expect to be able to grow VASCEPA revenues over time, no guidance should be inferred from the operating metrics described above. We also anticipate that such sales growth will be inconsistent from period to period. We believe that investors should view the above-referenced operating metrics with caution, as data for this limited period may not be representative of a trend consistent with the results presented or otherwise predictive of future results. Seasonal fluctuations in pharmaceutical sales, for example, may affect future prescription trends of VASCEPA, as could changes in prescriber sentiment, quarterly changes in distributor purchases, and other factors. We believe investors should consider our results over several quarters, or longer, before making an assessment about potential future performance. In Europe, privacy laws and other factors impact the availability of data to inform European commercial operations at an individual physician level. Generally, less data is available and at reduced frequencies as compared to the United States.

We also employ various medical affairs and marketing personnel to support our commercialization of VASCEPA. We expanded certain medical education and market awareness initiatives following the reporting of positive REDUCE-IT results in 2018. 26

We began 2020 by taking steps to further expand promotion of VASCEPA in the United States, including direct to consumer advertising, ~~as a result of~~based on the new indication and label expansion of VASCEPA. Our field sales efforts are further complemented by investments in digital and non-personal channels as well as peer-to-peer (e.g., promotional medical education programs and product theaters) initiatives to further increase VASCEPA ~~approved by the FDA on December 13, 2019.~~brand awareness and clarify VASCEPA’s unique clinical profile. In January 2020, we launched an educational campaign, True To Your Heart, to help people learn more about cardiovascular disease and how to better protect against persistent cardiovascular risk. At the start of 2020, we had intended to commence expanded promotion but cancelled such plans following the onset of COVID-19 and the prospects for a potential launch of generic versions of VASCEPA. We have restored most of that intended promotion and educational efforts which include the sponsorship of continuing medical education, social media-based communications, and advertisements on television and other forms of media.

On March 30, 2020, the Nevada Court ruled in favor of two generic companies in our patent litigation related to their ANDAs that seek FDA approval for sale of generic versions of VASCEPA. On May 22, 2020, one of the two generic companies, Hikma, received FDA approval to market its generic version of VASCEPA. To date, Hikma has not launched a generic version of VASCEPA.~~We disagree with the Nevada Court’s decision that our patents are invalid and are vigorously pursuing an appeal. If generic companies~~

~~determine to launch generic versions of icosapent ethyl in the United States, such competition could have a material and adverse impact on our revenues and our operations.~~

VASCEPA is not yet known to most healthcare professionals and generics companies rarely invest in product or disease state related market education. Furthermore, VASCEPA is relatively expensive to manufacture and already sold at an affordable price as documented by third-party analysis such that saving, if any, on the price of generic VASCEPA is likely to come at the expense of reduced market education and development. Thus, we believe that the launch of a generic version of VASCEPA in the United States at this early stage in the life cycle of VASCEPA is potentially harmful to patient care and discourages new product development, including for identifying and pursuing additional indications that could be treated with VASCEPA.

~~Geographies outside~~In the United States, in which VASCEPA is sold and under regulatory review are not subject to this U.S. patent litigation and judgment. No similar litigation involving potential generic versions of VASCEPA is pending outside the United States. VASCEPA is currently available by prescription in Canada, Lebanon and the United Arab Emirates. In Canada, VASCEPA has the benefit of eight years of data protection afforded through Health Canada (until the end of 2027), in addition to separate patent protection with expiration dates that could extend into 2039. Amarin is pursuing additional regulatory approvals for VASCEPA in Europe, China and the Middle East. In China and the Middle East, Amarin is pursuing such regulatory approvals and subsequent commercialization of VASCEPA with commercial partners. In Europe, Amarin is preparing to self-launch VASCEPA, although it may engage commercialization partners for certain of the smaller countries of Europe. Ten to eleven years of market protection is anticipated due to regulatory exclusivity in the European Union subject to an approval recommendation by the European Medicines Agency, or EMA, near the end ofJuly 2020 ~~and associated European Community, or EC, approval expected promptly thereafter, in addition to pending patent protection that could extend into 2039.~~

~~In addition to~~we launched our first television-based promotion of VASCEPA inemphasizing that it is the first and only U.S. FDA approved drug for its indication. As the impact of COVID-19 on much of the United States ~~based on REDUCE-IT,~~worsened in the fourth quarter of 2020, we ~~have increased focus on expansion~~suspended television-based promotion of ~~our development efforts for~~ VASCEPA ~~to major markets outside~~as we determined that the ~~United States. We currently have strategic collaborations to develop and commercialize VASCEPA~~cost was not sufficiently justified in ~~select territories outside the United States.~~

~~In February 2015, we announced an exclusive agreement with Eddingpharm to develop and commercialize VASCEPA capsules in what we refer to as the China Territory, consisting~~light of the ~~territories~~COVID-19 pandemic’s impact on patient visits to doctors. We resumed on a very limited basis, direct-to-consumer campaign in January 2021, including television-based promotion, digital and social media promotion to continue to grow consumer awareness of Mainland China, Hong Kong, Macau and Taiwan, for uses that are currently commercialized and under development by us in the United States. Eddingpharm, with our support, is conducting a clinical trial of VASCEPA in China, which is evaluatingVASCEPA. As we witnessed the effect of ~~VASCEPA on patients with very high triglyceride levels (~~>~~500 mg/dL). The results of this trial are expected~~COVID-19 persisting, we elected to ~~be announced before~~keep the end of 2020. After reviewing the results of this clinical study and consulting with regulatory authorities, our plans for seeking regulatory approval and reimbursement of VASCEPA in China will be updated.

In March 2016, we entered into an agreement with Biologix, to register and commercialize VASCEPA in several Middle Eastern and North African countries. VASCEPA was launched in Lebanon in June 2018 and in United Arab Emirates in February 2019, respectively.

In September 2017, we entered into an agreement with HLS to register, commercialize and distribute VASCEPA in Canada. In March 2019, HLS received formal confirmation from Health Canada that the Canadian regulatory authority has granted priority review status for the upcoming New Drug Submission, which was filed in April 2019, for VASCEPA. In December 2019, HLS received formal confirmation from Health Canada that the Canadian regulatory authority has granted approval for VASCEPA to reduce the risk of cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization or hospitalization for unstable angina) in statin-treated patients with elevated triglycerides, who are at high risk of cardiovascular events due to: established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor. In January 2020 HLS obtained a regulatory exclusivity designation. Commercial launch in Canada began in February 2020 on a limited scale with subsequent expansion intended. An important step in growing the potential use of therapeutics in Canada, as is true in other countries, is gaining reimbursement coverage by the applicable payers. In July 2020, the Canadian Health Authorities recommended that patients with established cardiovascular diseases under certain conditions be reimbursed for VASCEPA. In addition, the Patented Medicines Price Review Boards review of VASCEPA’s introductory price submission did not trigger the pricing investigation criteria. While coverage of patients with established cardiovascular disease represents a substantial portion of VASCEPA’s approved label in Canada, HLS intends various initiatives to pursue expanding the Canadian Health Authorities recommendation to cover other patients at high risk for major adverse cardiovascular events beyond patients with established cardiovascular disease.

~~We are exploring potential development and commercial paths for VASCEPA throughout Europe.~~

In December 2019, we announced that the EMA validated the marketing authorization application seeking approval for VASCEPA. The validation confirms the submission is sufficiently complete for the EMA to begin its review. Review by the EMA of this application is active and together with associated EC review, expected promptly thereafter, is expected to be completed in early 2021. As we did in Canada, we are seeking an indication throughout Europe for VASCEPA targeting cardiovascular risk reduction based on the results of REDUCE-IT.

In parallel with EMA’s review of our submission, we have been actively exploring the opportunity for VASCEPA commercialization in Europe. After extensive evaluation, we have determined self-launching VASCEPA in Europe, except perhaps in certain smaller countries of Europe, is the best path forward considering all factors. Such an approach avoids sharing the economic potential of VASCEPA with a third-party commercial partner and ensures that VASCEPA gets the highest level of ~~priority~~such promotion limited. We anticipate that at-risk patients will increasingly resume visiting their doctors for non-urgent medical care after they are vaccinated for COVID-19, however, we cannot accurately predict when this resumption in visits to doctors will occur. The timing is likely to vary by geography. As COVID-19 protocols ease and ~~focus.~~ ordinary course activities resume, we will seek to adjust our promotional initiatives accordingly, including pursuing increased face-to-face interactions with healthcare professionals and expanding various forms of direct-to-consumer promotion.

Similar to our approach in launching VASCEPA in the United States, in Europe we intend to build a core team of experienced professionals and a highly capable sales team involved with pre-launch planning and other commercial preparation activities and plan to leverage third-party relationships for various support activities. ~~Such activities are underway.~~ In Europe, patients at high risk for cardiovascular disease tend, in comparison to the United States, to be treated more often by specialists, such as cardiologists rather than by physicians who are general practitioners. ~~Pursuant to regulatory approval of VASCEPA in Europe, this~~This greater concentration of at-risk patients being treated by specialists in Europe should allow for more efficient promotion ~~of VASCEPA~~ in Europe than in the United States. We have been active in preparing for reimbursement negotiations which we ~~intend to~~will commence on a country-by-country basis in Europe, ~~following anticipated approval of VASCEPA following the currently ongoing EMA review.~~now that VAZKEPA received marketing authorization on March 26, 2021. In ~~certain~~most European countries, securing product reimbursement is a requisite to launching. In all countries securing adequate reimbursement is a requisite for commercial success of any therapeutic. The time required to secure reimbursement tends to vary from country to country and cannot be reliably predicted at this time. While we believe that we have strong arguments regarding the cost effectiveness of ~~VASCEPA,~~VAZKEPA, the success of such reimbursement negotiations could have a significant impact on our ability to realize the commercial opportunity of ~~VASCEPA~~VAZKEPA in Europe.

We plan to ~~also~~ assess other potential partnership opportunities for licensing VASCEPA to partners in other parts of the world. While we believe that there is medical need and opportunity for VASCEPA elsewhere in the world, our current priorities are the geographies described above.

Since its inception in 2011, conduct of the REDUCE-IT cardiovascular outcomes study of VASCEPA has been the centerpiece of our research and development. Most of our other research and development during this period also pertained to VASCEPA, including study of the mechanism of action of the single active ingredient in VASCEPA, icosapent ethyl. The REDUCE-IT study was conducted based on a special protocol assessment, or SPA, agreement with the FDA. Based on the final positive results of REDUCE-IT, we sought additional indicated uses for VASCEPA in the United States and continued to pursue approval for VASCEPA around the world. We also anticipate continuing to publish additional details of the REDUCE-IT study to address scientific interest beyond the primary results of this study derived from the over 35,000 patient years of study experience which were accumulated in the REDUCE-IT study. The REDUCE-IT study topline results were made public in September 2018, and the primary results of the REDUCE-IT ~~study~~STROKE subgroup analyses were presented at the ~~2018 Scientific Sessions of~~International Stroke Conference 2021 from March 17 - 19, 2021. The REDUCE-IT STROKE analyses examined stroke rates across the ~~AHA on November 10, 2018~~enrolled patient population (n=8179). Enrolled patients were required to be treated with ~~such results concurrently published in~~ ~~The New England Journal of Medicine~~. ~~The total (first~~statins and ~~subsequent) cardiovascular events results of the REDUCE-IT study were presented at the American College of Cardiology’s 68th Annual Scientific Session in March 2019~~other conventional therapies, and ~~concurrently published in the~~ ~~Journal of theAmerican College of Cardiology~~. Potential additional research and development opportunities beyond REDUCE-IT will be prioritized after giving priority to securing regulatory approval for VASCEPA based on the REDUCE-IT results in various geographies internationally, including pursuit of approval for VASCEPA in Europe and in countries where we have commercialization partners for VASCEPA.

The FDA granted Priority Review designation to our March 2019 sNDA seeking an expanded indication for VASCEPA in the United States based on the positive results of the REDUCE-IT study. The FDA grants Priority Review designation to applications for drugs that, if approved, have the potential to offer significant improvements in the effectiveness and safety of the treatment of serious conditions when compared to standard applications. In November 2019, FDA held an EMDAC meeting to review the REDUCE-IT sNDA. The EMDAC voted unanimously (16-0) to recommend approval of an indication and label expansion for VASCEPA to reduce cardiovascular events in high-riskall patients based on the REDUCE-IT results. On December 13, 2019, the FDA approved a new indication and related label expansion based on REDUCE-IT. VASCEPA is the first and only drug approved by the FDA as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated TG levels (≥150 mg/dL) andhad either established cardiovascular disease or diabetes ~~mellitus~~

and ~~two or more additional~~had other cardiovascular risk factors such as elevated triglyceride levels. Event rates for ~~cardiovascular disease.~~ ~~Reflecting the robust results of the clinical~~ ~~development program~~time to first fatal or nonfatal stroke were 2.4% for VASCEPA vs. 3.3% for placebo for a relative risk reduction of 28% (p=0.01). Ischemic stroke time to first event rates were 2.0% for VASCEPA vs. 3.0% for placebo for a RRR of 36% (p=0.002). Hemorrhagic stroke occurred at low rates with no ~~additional post-approval clinical study or other special post approval requirement (as often seen with other drug approvals) was requested by the FDA in conjunction with its approval of VASCEPA.~~significant difference for VASCEPA vs. placebo (0.3% vs 0.2%; p=0.55).

Based on our current understanding of the biological effects of a COVID-19 infection, including that patients at high risk of cardiovascular disease are at higher risk of mortality and severe effects from a COVID-19 infection, and based on data related to the mechanism of action and effects of VASCEPA in lowering cardiovascular risk in certain high-risk patients, we believe that VASCEPA could play a beneficial clinical role in helping patients infected by the virus. We are currently supporting investigator initiated studies by providing study drug product and limited financial support to investigators in multiple pilot studies designed to better understand the potential of VASCEPA and ~~this~~its potentially beneficial role. On December 12, 2020, we announced at the National Lipid Association Scientific Sessions 2020 positive clinical results from the first study of VASCEPA in COVID-19 infected outpatients, CardioLink-9. If the results of ~~these~~the other pilot studies are positive, we ~~intend to~~will evaluate whether additional ~~study is~~studies will be appropriate. The clinical effects of VASCEPA are multi-factorial. Multiple mechanisms of action associated with VASCEPA from clinical and mechanistic studies support the rationale to study its effects in patients with the COVID-19 infection. Additional postulated mechanisms that might play a role in the use of VASCEPA in the patients infected with COVID-19 include potential antiviral/antimicrobial effects, fibrosis and cardiac damage mitigation in animal models and anti-inflammatory effects (acute) in pulmonary/lung tissue.

In June 2018, we entered into a multi-faceted collaboration with Mochida related to the development and commercialization of drug products and indications based on the active pharmaceutical ingredient in VASCEPA, the omega-3 acid EPA. Among other terms in the agreement, we obtained an exclusive license to certain Mochida intellectual property to advance our interests in the United States and certain other territories. In addition, the parties will collaborate to research and develop new products and indications based on EPA for our commercialization in the United States and certain other territories. The potential new product and indication opportunities contemplated under this agreement are currently in early stages of development. Upon closing of the collaboration agreement, we made a non-refundable, non-creditable upfront payment of approximately $2.7 million. In addition, the agreement provides for milestone payments from us upon the achievement of certain product development milestones and royalties on net sales of future products arising from the collaboration, if any. In January 2020, we achieved certain milestones under the agreement, resulting in payment of $1.0 million to Mochida.

We manage the manufacturing and supply of VASCEPA internally and have done so since we began clinical development of VASCEPA prior to the drug’s marketing approval by U.S. FDA in 2012. We rely on contract manufacturers in each step of our

commercial and clinical product supply chain. These steps include active pharmaceutical ingredient, or API, manufacturing, encapsulation of the API, product packaging and supply-related logistics. Our approach to product supply procurement is designed to mitigate risk of supply interruption and maintain an environment of cost competition through diversification of contract manufacturers at each stage of the supply chain and lack of reliance on any single supplier. We have multiple U.S. FDA-approved international API suppliers, encapsulators and packagers to support the VASCEPA commercial franchise. We also have multiple international API suppliers, encapsulators and packagers to support the commercialization of VASCEPA in geographies where the drug is approved outside the United States. Not all of our suppliers approved by the U.S. FDA are approved in every other geography. In Europe, while certain of our suppliers are approved, after the impact of COVID-19 subsides and more readily allows for regulatory inspections, we will seek to expand the number of our suppliers approved for use in further product sales in Europe. The amount of supply we seek to purchase in future periods will depend on the level of growth of VASCEPA revenues and minimum purchase commitments with certain suppliers. While our current supply chain is scalable, we continue efforts to expand, diversify and further enhance it.

As of March 31, 2021, approximately 16% of the U.S. population has been fully vaccinated and approximately 30% of the U.S. population has received at least one dose of a vaccine. Despite the growing vaccine rate and growing number of those who are eligible to receive the vaccine, according to CDC data, as of March 31, 2021, new cases of COVID-19 ~~pandemic continues~~have been and continue to ~~spread~~increase in the U.S. and the pandemic’s impact on global populations and economies continues to remain. While we expect the number of new cases to decrease as more of the population is vaccinated, we continue to evaluate ~~its impact~~the pandemic’s effect on patients, distributors, customers and our employees, as well as on our operations and the operations of our business partners and communities. Given the importance of supporting patients, we are diligently working with our suppliers, customers, distributors and other partners to provide patients with access to VASCEPA, while taking into account regulatory, institutional, and government guidance, policies and protocols. Given the uncertainties regarding the scope, duration and impact of COVID-19 on our sales, supply, research and development efforts and operations, and on the operations of our customers, suppliers, distributors, other partners and patients, particularly as COVID-19 protocols and resources have restricted or discouraged patient access to hospitals, clinics, physicians’ offices and other administration sites and caused a reprioritization of health care services, the impact of COVID-19 could ~~materially~~ impact our current performance and ~~continue~~continues to represent a risk to our future performance.

~~Beginning in mid-March 2020, our~~Our ability to directly promote VASCEPA to healthcare professionals has been limited due to appropriate social distancing practices associated with COVID-19 and by patients electing to forego visiting their doctors for non-urgent medical examinations and/or ~~choose~~choosing to not get blood tests which ~~test~~the results of these tests provide useful information ~~useful~~ to the treatment of cardiovascular risk. ~~Such impact has~~These limitations have had a significant impact on slowing VASCEPA prescription and revenue growth. While COVID-19 continues to impact our promotion of VASCEPA, we ~~see early~~have seen signs of improvement. ~~Our~~As a result of the COVID-19 pandemic and the related social distancing, in March 2020, we suspended face-to-face interactions between our sales representatives ~~are increasingly gaining~~and healthcare professionals. We resumed on a limited basis field-based, face-to-face interactions with healthcare providers beginning in June 2020. During the late part of the summer of 2020, substantially all of our field force personnel were able to resume face-to-face customer interactions, in a manner consistent with guidelines from local, state and government health officials in the United States. In the fourth quarter of 2020 and continuing into the first quarter of 2021, the impact of COVID-19 worsened in much of the United States with some physicians again limiting access to ~~educate healthcare professionals regarding VASCEPA.~~face-to-face interactions with our field force personnel. Such access remains variable and challenging due to ~~COVID-19, yet we are optimistic that this improved access trend will increase and translate into increased levels of VASCEPA prescriptions and revenue.~~ COVID-19.

In the United States, in July 2020 we launched our first television-based promotion of VASCEPA emphasizing that it is the first and only U.S. FDA approved drug for ~~its~~the cardiovascular risk reduction indication. As the impact of COVID-19 on much of the United States worsened in the fourth quarter of 2020, we suspended television-based promotion of VASCEPA judging that the cost was not sufficiently justified. We resumed a limited direct-to-consumer campaign in January 2021, including television-based promotion, digital and social media promotion to continue to grow consumer awareness of VASCEPA. We anticipate that ~~over time such promotion~~at-risk patients will ~~increase awareness and usage of~~

~~VASCEPA, and could help mitigate challenges if social distancing protocols and other restrictions~~increasingly resume visiting their doctors for non-urgent medical care after they are ~~reinforced, including in light of any resurgence~~vaccinated for COVID-19. As more of the ~~infection in certain geographies. Data on~~population is vaccinated, COVID-19 protocols ease and ordinary course activities resume, we will seek to adjust our promotional initiatives accordingly, including pursuing increased ~~product usage from similar promotion~~face-to-face interactions with health care professionals and expanding various forms of ~~other products suggests that the impact of television-based promotion can be positive and sustained but is rarely immediate in its effect.~~direct-to-consumer promotion.

Thus far, COVID-19 has not materially impacted our ability to secure and deliver supply of VASCEPA. And, thus far, COVID-19 is not known to have significantly impacted ongoing clinical trials of VASCEPA. Regarding regulatory review of VASCEPA in Europe, COVID-19 appears to have modestly slowed certain aspects of the review with the overall timeline for the review being completed by the EMA shifting from what was previously estimated as late 2020 into our current estimate of early 2021.

The ultimate impacts of COVID-19 on our business are unknown; however, we are actively monitoring the situation and may take precautionary and preemptive or reactive actions that we determine are in the best interests of our business. We cannot predict the effects that such actions may have on our business or on our financial results, in particular with respect to demand for or access to VASCEPA.

We believe that the overall morale of our employees ~~within Amarin~~ is ~~positive~~good despite the challenges associated with COVID-19. ~~While~~As a result of COVID-19 and its limitations on our promotion of VASCEPA in the United States, we have ~~experienced modest employee turnover in recent months,~~intentionally slowed the ~~turnover level is generally consistent with the pre-COVID era. And, while in a period~~hiring of ~~social distancing we are intentionally slow in hiring~~ replacements for our ~~limited number of~~ open positions ~~resulting~~which resulted from ~~such seemingly~~ ordinary ~~course turnover, it is our intention to fill such positions particularly as~~turnover. When we witness our sales representatives increasingly able to resume direct interactions with healthcare ~~professionals.~~professionals, it is our intention to fill a significant number of these positions, provided such replacements are then appropriate to meet our business needs, which we continually evaluate.

In April 2021, we announced that John Thero, President and Chief Executive Officer, will retire from his positions as President and Chief Executive Officer and member of the Board of Directors effective August 1, 2021 and will provide phased transitional and consulting services to us thereafter. The Board of Directors has appointed Karim Mikhail, currently our Senior Vice President, Commercial Head Europe, to succeed Mr. Thero as our next President and Chief Executive Officer, as well as, a member of the Board of Directors, effective August 1, 2021. In April 2021, we also announced that Joseph Kennedy will retire from his position as Executive Vice President, General Counsel. A search has commenced to hire a new General Counsel with Mr. Kennedy also intending to support this transition and to provide consulting support on certain legal matters.

Product revenue, net. All of our product revenue is derived from product sales of 1-gram and 0.5-gram size capsules of VASCEPA, net of allowances, discounts, incentives, rebates, chargebacks and returns. In the United States, we sell product to a limited number of major wholesalers, as well as selected regional wholesalers and specialty pharmacy providers, or collectively, our distributors or our customers, who resell the product to retail pharmacies for purposes of their reselling the product to fill patient prescriptions. ~~We commenced our commercial launch of 1-gram size VASCEPA capsules in the United States in January 2013, and introduced a smaller 0.5-gram capsule size in October 2016.~~ Revenues from product sales are recognized when the Distributor obtains control of our product, which occurs at a point in time, typically upon delivery to the Distributor. Timing of shipments to wholesalers, as used for revenue recognition, and timing of prescriptions as estimated by third-party sources such as Symphony Health and IQVIA may differ from period to period. During the quarters ended March 31, 2021 and 2020, our Product revenue, net included adjustment for co-pay mitigation rebates provided by us to commercially insured patients. Such support is intended for offset for a portion of the out-of-pocket expense that patients are required to pay for VASCEPA based upon the benefit design of their prescription drug coverage. Our cost for these co-payment support payments in both of the quarters ended March 31, 2021 and 2020 was up to $150 per 30-day prescription filled and up to $450 90-day prescription filled.

Outside of the United States, currently all our product revenue is derived from the sales of VASCEPA to our commercial partners based on the net price for VASCEPA established in our contracts with such partners. These commercial partners then resell the product in their agreed commercial territory. Revenues from product sales to our international commercial partners are recognized when the commercial partners obtain control of our product, which occurs at a point in time, typically upon delivery to the commercial partner. The net price of VASCEPA sold by us to our customers where we directly sell VASCEPA is generally significantly higher than the net price of VASCEPA that we sell to commercial partners who then incur the cost of promoting and reselling the product in their territories. As a result, even when the net price of VASCEPA to patients is similar in various parts of the world, our gross margin on sales is higher where we sell VASCEPA directly. Currently the majority of our ~~products~~product revenue is derived from direct sales of VASCEPA in the United States.

Licensing and royalty revenue. Licensing and royalty revenue currently consists of revenue attributable to receipt of up-front, non-refundable payments, milestone payments and sales-based payments related to license and distribution agreements for VASCEPA outside the United States. We recognize revenue from licensing arrangements as we fulfill the performance obligations under each of the agreements.

Cost of goods sold. Cost of goods sold includes the cost of API for VASCEPA on which revenue was recognized during the period, as well as the associated costs for encapsulation, packaging, shipment, supply management, quality assurance, insurance, and other indirect manufacturing, logistics and product support costs. The cost of the API included in Cost of goods sold reflects the average cost method of inventory valuation and relief. This average cost reflects the actual purchase price of VASCEPA API. Our cost of goods sold is not materially impacted by whether we sell VASCEPA directly in a country or we sell VASCEPA to a commercial partner for resale in a country.

Selling, general and administrative expense. Selling, general and administrative expense consists primarily of salaries and other related costs, including stock-based compensation expense, for personnel in our sales, marketing, executive, business development, finance and information technology functions. Other costs primarily include facility costs and professional fees for accounting, consulting and legal services.

Research and development expense. Research and development expense consists primarily of fees paid to professional service providers in conjunction with independent monitoring of our clinical trials and acquiring and evaluating data in conjunction with our clinical trials, fees paid to independent researchers, costs of qualifying contract manufacturers, costs associated with supporting investigator initiated studies, services expenses incurred in developing and testing products and product candidates, salaries and related expenses for personnel, including stock-based compensation expense, costs of materials, depreciation, rent, utilities and other facilities costs. In addition, Research and development expenses include the cost to support current development efforts, costs of product supply received from suppliers when such receipt by

us is prior to regulatory approval of the supplier, as well as license fees related to our strategic collaboration with ~~Mochida Pharmaceutical Co., Ltd.~~Mochida. We expense research and development costs as incurred.

Interest and other (expense) income, net. Interest expense consists of interest incurred under our December 2012 royalty-bearing instrument financing arrangement, which iswas calculated based on an estimated repayment ~~schedule.~~schedule and was paid in full in 2020. Interest income consists of interest earned on our cash and cash equivalents, as well as our ~~short~~short-term and long-term investments. Other (expense) income, net, consists primarily of foreign exchange losses and gains.

Income tax (provision) benefit. Income tax (provision) benefit, deferred tax assets and liabilities, and reserves for unrecognized tax benefits reflect management’s best assessment of estimated future taxes to be paid. We are subject to income taxes in both the United States and foreign jurisdictions. In applying guidance prescribed under ASC 740 and based on present evidence and conclusions around the realizability of deferred tax assets, we determined that any tax benefit related to the pretax losses generated for the ~~three~~first quarters of 2021 and ~~six months ended June 30,~~ 2020 ~~and 2019~~ are not more likely than not to be realized. On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, was enacted in the United States. Among other provisions, the CARES Act allows businesses to carry back net operating losses arising in years 2018 to 2020 to the five prior tax years. We recorded an income tax benefit of nil million and $2.4 million for the three and six months ended June 30, 2020 as a result of these loss carrybacks and an income tax benefit of nil for the three and six months ended June 30, 2019.

Our discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements and notes, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expenses. On an ongoing basis, we evaluate our estimates and judgments. We base our estimates on historical experience and on various market-specific and other relevant assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. Estimates are assessed each period and updated to reflect current information. A summary of our critical accounting policies, significant judgments and estimates is presented in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, ~~2019.~~2020. There were no material changes to our critical accounting policies, significant judgments and estimates during the ~~six~~three months ended ~~June 30, 2020.~~March 31, 2021.

For a discussion of recent accounting pronouncements, see Note 2—Significant Accounting Policies in the accompanying Notes to Condensed Consolidated Financial Statements included in Item 1 of this Quarterly Report on Form 10-Q for additional information.

We believe the impact of inflation on operations has been minimal during the past three years.

Comparison of Three Months Ended ~~June 30,~~March 31, 2021 and March 31, 2020 ~~and June 30, 2019~~

~~Product~~Total revenue, net. We recorded total revenue, net, ~~product revenue~~ of ~~$133.7~~$142.2 million and ~~$100.4~~$155.0 million during the three months ended ~~June 30,~~March 31, 2021 and 2020, ~~and 2019,~~ respectively, ~~an increase~~a decrease of ~~$33.4~~$12.8 million, or ~~33%~~8%. ~~This increase was driven~~Total revenue, net consists primarily ~~by volume~~of revenue from the sale of VASCEPA ~~sales to our customers in the United States, as well as a modest increase in VASCEPA’s net selling price~~ in the United States. ~~Orders by such customers were supported by an increase in estimated normalized total VASCEPA prescriptions in~~In addition to the United States, ~~reflecting various factors including managed care improvements. Based on data provided~~VASCEPA is currently available by ~~Symphony Health~~prescription in Canada, Lebanon and~~IQVIA, estimated normalized total VASCEPA prescriptions in~~ the United ~~States increased by approximately 335,000 and 324,000, respectively, over the three months ended June 30, 2019, representing growth~~Arab Emirates through collaborations with third-party companies. As further discussed below, this decrease consists of ~~44% and 47%, respectively. The increase in~~a $6.2 million decrease from net product revenue ~~was also driven by~~from sales of VASCEPA ~~sales to our commercial partners~~ outside of the United States, a $4.6 million decrease in U.S. net product revenue and a $2.0 million decrease in licensing and royalty revenue.

Product revenue, net. We recorded product revenue, net, of ~~approximately $1.8~~$141.4 million and $152.2 million during the three months ended ~~June 30,~~March 31, 2021 and 2020, respectively, a decrease of $10.8 million, or 7%. This decrease was driven primarily by five factors, which are further described below: 1) effectively one fewer week of shipments in the first quarter of 2021 as compared to ~~nil during~~ the ~~three months ended June 30, 2019.~~first quarter of 2020; 2) COVID-19; 3) generic competition; 4) regional adverse weather conditions and 5) timing of international sales. In addition, compared with other quarters of the year, beginning of the year deductibles under patient insurance plans, which are not unique to VASCEPA, tends to cause some patients to not fill prescriptions particularly for asymptomatic medical conditions.

In the fourth quarter of ~~our product revenue, net~~2020, the impact of COVID-19 worsened in much of the United States, in the three months ended June 30, 2020 and 2019 was derived from product sales of 1-gram and 0.5-gram size capsules of VASCEPA, net of allowances, discounts, incentives, rebates, chargebacks and returns. The U.S. FDA-approved dosing for VASCEPA continueswith some physicians who began to ~~be 4 grams per day and, as expected, the majority of new and existing patients taking VASCEPA continue~~allow access to ~~be prescribed the 1-gram size VASCEPA capsules. Timing of shipments~~our field based personnel again limiting access to ~~wholesalers, as used for revenue recognition, and timing of prescriptions as estimated by third-party sources such as Symphony Health and~~ ~~IQVIA~~ ~~may differ from period to period.~~

During the quarters ended June 30, 2020 and 2019, our Product revenue, net in the United States included adjustment for co-pay mitigation support provided by us for commercially insured patients. Such rebates are intended to offset a portion of the out-of-pocket expense that patients are required to pay for VASCEPA based upon the benefit of their insurances. Our cost for these co-payment support payments during the quarters ended June 30, 2020 and 2019 was up to $150 and $110, respectively per 30-day prescription filled and, up to $450 and $330, respectively per 90-day prescription filled.

~~As is typical for the pharmaceutical industry, the majority of VASCEPA sales in the United States are to major commercial wholesalers which then resell VASCEPA to retail pharmacies.~~

In March 2020, COVID-19, or SARS-CoV-2, became widespread in the United States and other geographies around the globe. In recognition of guidance from public health officials, we announced on March 15, 2020 a temporary suspension of in-person promotional activities. In June 2020, we resumed sales force, field-based, face-to-face ~~interactions with healthcare providers in a phased approach that is consistent with guidelines from local, state and government health officials in the United States.~~interactions. For a ~~newly~~U.S. FDA-approved drug like VASCEPA to be prescribed, historically physicians need to have met with their patients for an examination and have received blood test results prior to prescribing the drug to the patient. ~~Public~~The first quarter of 2020 included two weeks of significant COVID-19 related impact, while the full three months of the first quarter of 2021 was impacted by COVID-19 and public reports from IQVIA showed patient visits ~~to medical offices for non-emergency medical care were down approximately 70% in April 2020~~on average during the height of the COVID-19 related social distancing. Also reported was a significant drop in the number of routine lab tests likely due to patients not seeking medical care for non-urgent medical needs and resources of the medical community shifting focus to address the COVID-19 pandemic. As a result, while VASCEPA prescription levels in the three months ended June 30, 2020 grew over the three months ended June 30, 2019, we witnessed a slowing of new patients being prescribed VASCEPA resulting in year over year growth in the three months ended June 30, 2020 which was considerably slower than the growth reported in the three months ended March 31, 2021 were down to approximately 78% of the first quarter 2020 when we launched VASCEPA for its new cardiovascular indication. According to IQVIA data, in June 2020 the number of patient visits to health care providers and the number of lab tests increased meaningfully over the lows of April 2020 but remained below the volume levels reported prior to mid-March 2020 when the impact of COVID-19 began to significantly impact the United States.pre-COVID levels. We cannot predict the duration of this pandemic and we cannot quantify the impact of COVID-19 on our business beyond ~~June 30,~~March 31, 2021.

We ~~are~~remain confident that the patient need for VASCEPA ~~remains~~is high and that a significant portion of the slowing of VASCEPA growth ~~in the three months ended June 30, 2020 was~~is COVID-19 related. While we are optimistic that the worst of the COVID-19 impact is behind us regarding the levels of patients seeking ordinary course doctor visits and lab tests, we expect that COVID-19 will continue, at least in the near term, to impact the level of VASCEPA prescriptions and the degree and timing to which we can, if at all, reaccelerate VASCEPA growth, particularly if there are resurgences in the spread of the infection in various geographies and a reinforcement of social distancing and other protocols. In addition, as patients, pharmacies and payers adjust to the availability, pricing and label of generic competition variability is expected. As a result of the uncertainty of the extent of COVID-19, the impact of generic competition and challenges for most drugs seeking market access in Europe, a process we were only able to formally commence following product approval in March 2021, we are not providing quantified revenue guidance at this time. We will consider resuming revenue guidance when there is greater clarity on the impact of these issues.

Licensing and royalty revenue. Licensing and royalty revenue during the three months ended ~~June 30,~~March 31, 2021 and 2020 ~~and 2019~~ was ~~$1.6~~$0.8 million and ~~$0.4~~$2.8 million, respectively, ~~an increase~~a decrease of ~~$1.2~~$2.0 million, or ~~274%~~72%. Licensing and royalty revenue relates to the recognition of amounts received in connection with the following VASCEPA licensing agreements:

The up-front and milestone payments are being recognized over the estimated period in which we are required to provide regulatory and development support pursuant to the agreements. The amount of licensing and royalty revenue is expected to vary from period to period based on timing of milestones achieved and changes in estimates of the timing and level of support required.

As part of our licensing agreements with certain territories outside of the United States, we are entitled to a percentage of revenue earned based on sales by our partners. The royalty payments are being recognized as earned based on revenue recognized by our current partners.

Cost of goods sold. Cost of goods sold during the three months ended ~~June 30,~~March 31, 2021 and 2020 ~~and 2019~~ was ~~$28.8~~$28.3 million and ~~$22.8~~$34.8 million, respectively, ~~an increase~~a decrease of ~~$6.0~~$6.5 million, or ~~26%~~19%. Cost of goods sold includes the cost of API for VASCEPA on which revenue was recognized during the period, as well as the associated costs for encapsulation, packaging, shipment, supply management, insurance and quality assurance. The cost of the API included in cost of goods sold reflects the average cost of API included in inventory. This average cost reflects the actual purchase price of VASCEPA API.

The API included in the calculation of the average cost of goods sold during the quarters ended ~~June 30,~~March 31, 2021 and 2020 ~~and 2019~~ was sourced from multiple API suppliers. These suppliers compete with each other based on cost, consistent quality, capacity, timely delivery and other factors. In the future, we may see the average cost of supply change based on numerous potential factors including increased volume purchases, continued improvement in manufacturing efficiency, the mix of purchases made among suppliers, currency exchange rates and other factors. We currently anticipate API average cost in ~~2020~~2021 to be similar to or modestly lower than ~~2019.~~2020. The average cost may be variable from period to period depending upon the timing and quantity of API purchased from each supplier.

Our overall gross margin on product sales for each of the three months ended ~~June 30,~~March 31, 2021 and 2020 ~~and 2019~~ was ~~78%~~80% and 77%, respectively. The increase in gross margin on product sales is driven by gross margin on U.S. product sales of 79%, partially offset by the gross margin on product sales to our partners outside the U.S. which was based on contractually agreed upon terms with our commercial partners in those territories which partners incur the costs of promoting and selling the product in their territories. During the three months ended June 30, 2019, there were no product sales to our partners outside the U.S. to impact gross margin levels.

Selling, general and administrative expense. Selling, general and administrative expense for the three months ended ~~June 30,~~March 31, 2021 and 2020 ~~and 2019~~ was ~~$92.4~~$105.8 million and ~~$73.4~~$133.9 million, respectively, ~~an increase~~a decrease of ~~$19.0~~$28.1 million, or ~~26%~~21%. Selling, general and administrative expenses for the three months ended ~~June 30,~~March 31, 2021 and 2020 ~~and 2019~~ are summarized in the table below:

We anticipate our selling, general and administrative expenses to increase throughout 2021 primarily due to the costs associated with preparing VAZKEPA for commercial launch in Europe and subject to market access, launching VAZKEPA in one or more

countries in Europe during 2021. We plan to expand to approximately 300 professionals by the end of 2021. As we work to increase revenue from VASCEPA, we continuously evaluate all of our spending commitments and priorities ~~including the impact of the pending ANDA patent litigation~~ and ~~COVID-19 and as~~ we work to increase revenue from VASCEPA. We currently plan to spend approximately $80.0 million in education and promotion in 2020 to increase awareness of VASCEPA as the only U.S. FDA-approved drug for lowering the risk of heart attacks, strokes, and other major adverse cardiovascular events in high risk patients beyond statin therapy. We plan to adjust our level of education and promotional activities based on various factors, including ~~whether any~~the impact of COVID-19 and generic ~~company takes the risk of launching a generic version of VASCEPA during the patent litigation appeal process and the amount of any product launched.~~competition.

Research and development expense. Research and development expense for the three months ended ~~June 30,~~March 31, 2021 and 2020 ~~and 2019~~ was ~~$10.0~~$9.4 million and ~~$7.1~~$10.3 million, respectively, ~~an increase~~a decrease of ~~$2.8~~$0.9 million, or ~~40%~~9%. Research and development expenses for the three months ended ~~June 30,~~March 31, 2021 and 2020 ~~and 2019~~ are summarized in the table below:

~~The increase in research and development expenses for the quarter ended June 30, 2020, as compared to the prior year period, is primarily due to timing of REDUCE-IT and related costs.~~

We are in the process of evaluating all of our spending commitments and priorities on research and development activities. Our research and development expenses may be variable in the coming quarters as we advance analysis of samples collected from REDUCE-IT patients, consider potential investigator initiatives involving VASCEPA and cardiovascular risk mitigation in COVID-19 patients, support international regulatory review of VASCEPA, particularly in Europe, and adjust to the potential impact of the launch of generic versions of VASCEPA in the United States.

~~Interest income (expense), net~~. Net interest income (expense) for the three months ended June 30, 2020 and 2019 was $0.2 million and $0.8 million, respectively, a decrease of $0.6 million, or 81%. Net interest income for the three months ended June 30, 2020 and 2019 is summarized in the table below:

~~Other income (expense), net~~. Other income (expense), net for each of the three months ended June 30, 2020 and 2019 was income of $0.1 million and expense of $0.1 million, respectively. Other income (expense), net, primarily consists of gains and losses on foreign exchange transactions.

~~Product revenue, net.~~ We recorded net product revenue of $285.9 million and $173.1 million during the six months ended June 30, 2020 and 2019, respectively, an increase of $112.8 million, or 65%. This increase was driven primarily by volume of VASCEPA sales to our customers in the United States, as well as a modest increase in VASCEPA’s net selling price in the United States. Orders by such customers were supported by an increase in estimated normalized total VASCEPA prescriptions in the United States, reflecting various factors including managed care improvements. Based on data provided by Symphony Health and ~~IQVIA~~, estimated normalized total VASCEPA prescriptions in the United States increased by approximately 778,000 and 733,000, respectively, over the six months ended June 30, 2019, representing growth of 57% and 59%, respectively. The increase in net product revenue was also driven by VASCEPA sales to our commercial partners outside of the United States of approximately $8.5 million during the six months ended June 30, 2020 as compared to $0.3 million during the six months ended June 30, 2019, primarily as a result of an initial order to ensure availability of adequate product supply for the launch of VASCEPA in Canada, such revenue is based on contractually agreed pricing and other terms.

All of our product revenue, net in the United States, in the six months ended June 30, 2020 and 2019 was derived from product sales of 1-gram and 0.5-gram size capsules of VASCEPA, net of allowances, discounts, incentives, rebates, chargebacks and returns. The U.S. FDA-approved dosing for VASCEPA continues to be 4 grams per day and, as expected, the majority of new and existing patients taking VASCEPA continue to be prescribed the 1-gram size VASCEPA capsules. Timing of shipments to wholesalers, as used for revenue recognition, and timing of prescriptions as estimated by third-party sources such as Symphony Health and ~~IQVIA~~ ~~may differ from period to period.~~

During the six months ended June 30, 2020 and 2019, our Product revenue, net in the United States included adjustment for co-pay mitigation support provided by us for commercially insured patients. Such rebates are intended to offset a portion of the out-of-pocket expense that patients are required to pay for VASCEPA based upon the benefit of their insurances. Our cost for these co-payment support payments during the six months ended June 30, 2020 and 2019 was up to $150 and $110, respectively, per 30-day prescription filled and, up to $450 and $330, respectively per 90-day prescription filled.

~~As is typical for the pharmaceutical industry, the majority of VASCEPA sales in the United States are to major commercial wholesalers which then resell VASCEPA to retail pharmacies.~~

In March 2020, COVID-19, or SARS-CoV-2, became widespread in the United States and other geographies around the globe. In recognition of guidance from public health officials, we announced on March 15, 2020 a temporary suspension of in-person promotional activities. In June 2020, we resumed sales force, field-based, face-to-face interactions with healthcare providers in a phased approach that is consistent with guidelines from local, state and government health officials in the United States. For a newly FDA-approved drug like VASCEPA to be prescribed, historically physicians need to have met with their patients for an examination and have received blood test results prior to prescribing the drug to the patient. Public reports from IQVIA showed patient visits to medical offices for non-emergency medical care were down approximately 70% in April 2020 during the height of the COVID-19 related social distancing. Also reported was a significant drop in the number of routine lab tests likely due to patients not seeking medical care for non-urgent medical needs and resources of the medical community shifting focus to address the COVID-19 pandemic. As a result, while VASCEPA prescription levels in the three months ended June 30, 2020 grew over the three months ended June 30, 2019, we witnessed a slowing of new patients being prescribed VASCEPA resulting in year over year growth in June 30, 2020 which was considerably slower than the growth reported in the three months ended March 31, 2020 when we launched VASCEPA for its new cardiovascular indication. According to IQVIA data, in June 2020 the number of patient visits to health care providers and the number of lab tests increased meaningfully over the lows of April 2020 but remained below the volume levels reported prior to mid-March 2020 when the impact of COVID-19 began to significantly impact the United States. We cannot predict the duration of this pandemic and we cannot quantify the impact of COVID-19 on our business beyond June 30, 2020. We are confident that the patient need for VASCEPA remains high and that the slowing of VASCEPA growth in the three months ended June 30, 2020 was COVID-19 related. While we are optimistic that the worst of the COVID-19 impact is behind us regarding the levels of patients seeking ordinary course doctor visits and lab tests, we expect that COVID-19 will continue, at least in the near term, to impact the level of VASCEPA prescriptions and the degree and timing to which we can, if at all, reaccelerate VASCEPA growth, particularly if there are resurgences in the spread of the infection in various geographies and a reinforcement of social distancing and other protocols.

~~Licensing and royalty revenue~~. Licensing and royalty revenue during the six months ended June 30, 2020 and 2019 was $4.4 million and $1.0 million, respectively, an increase of $3.4 million, or 350%. Licensing revenue relates to the recognition of amounts received in connection with the following VASCEPA licensing agreements:

The up-front and milestone payments are being recognized over the estimated period in which we are required to provide regulatory and development support pursuant to the agreements. The amount of licensing revenue is expected to vary from period to period based on timing of milestones achieved and changes in estimates of the timing and level of support required.

~~Cost of goods sold.~~ Cost of goods sold during the six months ended June 30, 2020 and 2019 was $63.6 million and $39.9 million, respectively, an increase of $23.7 million, or 59%. Cost of goods sold includes the cost of API for VASCEPA on which revenue was recognized during the period, as well as the associated costs for encapsulation, packaging, shipment, supply management, insurance and quality assurance. The cost of the API included in cost of goods sold reflects the average cost of API included in inventory. This average cost reflects the actual purchase price of VASCEPA API.

The API included in the calculation of the average cost of goods sold during the quarters ended June 30, 2020 and 2019 was sourced from multiple API suppliers. These suppliers compete with each other based on cost, consistent quality, capacity, timely delivery and other factors. In the future, we may see the average cost of supply change based on numerous potential factors including increased volume purchases, continued improvement in manufacturing efficiency, the mix of purchases made among suppliers, currency exchange rates and other factors. We currently anticipate API average cost in 2020 to be similar to or modestly lower than 2019. The average cost may be variable from period to period depending upon the timing and quantity of API purchased from each supplier.

Our overall gross margin on product sales for each of the six months ended June 30, 2020 and 2019 was 78% and 77%, respectively. The increase in gross margin on product sales is driven by gross margin on U.S. product sales of 80%, partially offset by the gross margin on product sales to our partners outside the U.S. which was based on contractually agreed upon terms with our commercial partners in those territories which partners incur the costs of promoting and selling the product in their territories. During the six months ended June 30, 2019, the $0.3 million product sales to our partners outside the U.S. had a negligible impact on gross margin levels.

~~Selling, general and administrative expense~~. Selling, general and administrative expense for the six months ended June 30, 2020 and 2019 was $226.3 million and $145.0 million, respectively, an increase of $81.3 million, or 56%. Selling, general and administrative expenses for the six months ended June 30, 2020 and 2019 are summarized in the table below:

We continuously evaluate all of our spending commitments and priorities, including the impact of the pending ANDA patent litigation and COVID-19 and as we work to increase revenue from VASCEPA. We currently plan to spend approximately $80.0 million in education and promotion in 2020 to increase awareness of VASCEPA as the only U.S. FDA-approved drug for lowering the risk of heart attacks, strokes, and other major adverse cardiovascular events in high risk patients beyond statin therapy. We plan to adjust our level of education and promotional activities based on various factors, including whether any generic company takes the risk of launching a generic version of VASCEPA during the patent litigation appeal process and the amount of any product launched.

~~Research and Development Expense~~. Research and development expense for the six months ended June 30, 2020 and 2019 was $20.2 million and $14.4 million, respectively, an increase of $5.9 million, or 41%. Research and development expenses for the six months ended June 30, 2020 and 2019 are summarized in the table below:

~~The increase in research and development expenses for the six months ended June 30, 2020, as compared to the prior year period, is primarily due to timing of REDUCE-IT and related costs.~~

We ~~are~~anticipate our research and development expenses to remain consistent in 2021 with the ~~process of evaluating~~prior year. We continuously evaluate all of our spending commitments and priorities onand we plan to adjust our level of research and development ~~activities. Our research and development expenses may be variable in~~activities based on the coming quarters as we advance analysis of samples collected from REDUCE-IT patients, consider potential investigator initiatives involving VASCEPA and cardiovascular risk mitigation in COVID-19 patients, support international regulatory review of VASCEPA, particularly in Europe, and adjust to the potential impact of ~~the launch of~~COVID-19 and generic ~~versions of VASCEPA in the United States.~~competition.

Interest income, ~~(expense),~~ net. Net interest income ~~(expense)~~ for the ~~six~~three months ended ~~June 30,~~March 31, 2021 and 2020 ~~and 2019~~ was ~~income of $1.4~~$0.5 million and ~~expense of $0.9~~$1.2 million, respectively, ~~an increase~~a decrease of ~~$2.3~~$0.7 million, or ~~250%~~61%. Net interest income ~~(expense)~~ for the ~~six~~three months ended ~~June 30,~~March 31, 2021 and 2020 ~~and 2019~~ is summarized in the table below:

Other ~~income (expense),~~expense, net. Other ~~income (expense),~~expense, net, for the ~~six~~three months ended ~~June 30,~~March 31, 2021 and 2020 ~~and 2019~~ was ~~nominal and~~ expense of ~~$0.1 million,~~$142 thousand and $91 thousand, respectively. Other ~~income (expense),~~expense, net, primarily consists of gains and losses on foreign exchange transactions.

Income tax ~~benefit~~(provision) benefit.. Income tax (provision) benefit for the ~~six~~three months ended ~~June 30,~~March 31, 2021 and 2020 was a provision of $0.6 million and ~~2019 was~~benefit of $2.4 million, ~~and nil,~~ respectively. The provision for the three months ended March 31, 2021 is the result of income generated by our U.S. operations for which tax expense has been recognized based on a full year estimated U.S. income tax liability. The income tax benefit recorded for the ~~period~~three months ended ~~June 30,~~March 31, 2020 ~~relates~~related to ~~the carryback~~carrybacks of ~~U.S.~~ net operating losses as ~~permitted~~allowed under the CARES Act enacted in March 2020. The provision for each period is the result of losses generated by our U.S. and non-U.S. operations for which no tax benefit other than the benefit related to the loss carryback has been recognized based on our position that deferred tax benefits are not more likely than not to be realized based on available evidence.Act.

Our aggregate sources of liquidity as of ~~June 30, 2020 exceeds $600.0~~March 31, 2021 are in excess of $500.0 million, ~~which includes~~with no debt. Our aggregate sources of liquidity include cash and cash equivalents and restricted cash of ~~$217.9~~$294.9 million, short-term investments of ~~$336.3~~$223.7 million and long-term investments of ~~$61.0~~$24.0 million. Our cash and cash equivalents primarily include checking accounts and money market funds with original maturities less than 90 days. Our short-term investments consist of held-to-maturity securities that will be due in one year or less. Our long-term investments consist of held-to-maturity securities that will be due in more than one year. We invest cash in excess of our immediate requirements, in accordance with our investment policy, which limits the amounts we may invest in any one type of investment and requires all investments held by us to maintain minimum ratings from Nationally Recognized Statistical Rating Organizations so as to primarily achieve our goals of liquidity and capital preservation.

Our cash flows from operating, investing and financing activities, as reflected in the ~~condensed~~ consolidated statements of cash flows, are summarized in the following table:

Net ~~cash provided in operating activities during the six months ended June 30, 2020 compared net~~ cash used in operating activities during the three months ended March 31, 2021 as compared to the net cash provided by operating activities during the same period in ~~2019 increased~~2020 is primarily as a result of ~~higher collections due to~~ an increase in ~~product sales, partially offset by~~inventory purchases during 2021 as well as costs associated with ~~expanding our United States-based sales force, as well as increased costs of promotional activities following the successful REDUCE-IT study results.~~planning for commercial launch in Europe.

Net cash ~~used in~~provided by investing activities during the ~~six~~three months ended ~~June 30, 2020~~March 31, 2021 is primarily due to the proceeds from the maturity of $127.9 million in investment-grade interest bearing instruments, with no purchases of additional securities as compared to the same period in ~~2019 increased as a result of our purchasing~~2020 where approximately ~~$527.5~~$310.6 million investment-grade interest bearing instruments ~~during 2020,~~were purchased, partially offset by ~~$131.4 million in~~the proceeds from the maturity and sale of securities.

Net cash used byin financing activities during the ~~six~~three months ended ~~June 30,~~March 31, 2020 ~~increased as compared to~~primarily reflects the ~~same period in the prior year, primarily due to a decrease in the number of stock options that were exercised during the period and an increase in the payment~~payments made on our royalty-bearing ~~instrument.~~

instrument with CPPIB, with the final payment made in the fourth quarter of 2020. In December 2012, we entered into a financing agreement with BioPharma. Under this agreement, we granted to BioPharma a security interest in future receivables and all related rights to VASCEPA, in exchange for $100.0 million received at the closing of the agreement which ~~closing~~ occurred in December 2012. In December 2017, BioPharma assigned all rights under this agreement to CPPIB. WeIn the fourth quarter of 2020, we have repaid the remaining amounts outstanding of the agreed ~~to repay up to~~upon $150.0 million of future revenue and receivables. As of June 30, 2020, the net remaining amount to be repaid to CPPIB is $23.0 million, which will be repaid in quarterly installments calculated as 10% of quarterly VASCEPA net revenues. We can prepay the net remaining amount at any time. million.

As of ~~June 30, 2020,~~March 31, 2021, we had net accounts receivable ~~$125.0~~$151.3 million and inventory of ~~$124.8~~$230.9 million. We have incurred annual operating losses since our inception and, as a result, we had an accumulated deficit of $1.4 billion as of ~~June 30, 2020.~~March 31, 2021. We anticipate that quarterly net cash outflows in future periods will continue to be variable as a result of the timing of certain items, including our purchases of API, ~~VASCEPA promotional activities from approval by the FDA for the new indication and expanded label and~~ the impact from COVID-19 on our operations, ~~and those of our customers, any potential~~the generic competition in the United States as a result of our ANDA litigation and commercialization of ~~VASCEPA~~VAZKEPA in Europe. For Europe, we ~~anticipate~~commenced pre-launch planning and other commercial preparation activities, with plans to expand to approximately 300 professionals by the ~~number~~end of ~~added employees to be hired in 2020 to be fewer than twenty professionals as the initial focus in Europe is on regulatory approval and reimbursement.~~2021.

We believe that our cash and cash equivalents of ~~$214.0~~$291.0 million as of ~~June 30, 2020~~March 31, 2021 together with our short-term investments of ~~$336.3~~$223.7 million as of ~~June 30, 2020,~~March 31, 2021, will be sufficient to fund our projected operations for at least twelve months and is adequate to achieve positive cash flow from VASCEPA based on our current plans. We have based this estimate on assumptions that may prove to be wrong, including as a result of the risks discussed ~~below~~ under Part II, Item IA, “Risk Factors”, and we could use our capital resources sooner than we expect or fail to achieve positive cash flow.

Our contractual obligations consist mainly of payments related to purchase obligations with certain supply chain contracting parties and operating leases related to real estate used as office ~~space and debt and related interest.~~space. There have been no material changes during the ~~six~~three months ended ~~June 30, 2020~~March 31, 2021 to our contractual obligations as presented in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, ~~2019.~~

We do not have any special purpose entities or other off-balance sheet arrangements.

There have been no material changes with respect to the information appearing in PART II, Item 7A “Quantitative and Qualitative Disclosures about Market Risk” of our Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 25, ~~2020.~~2021.

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Securities Exchange Act of 1934, as amended or,or the ~~Exchange~~“Exchange Act, is (1) recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and (2) accumulated and communicated to our management, including our Principal Executive Officer and Principal Financial Officer, to allow timely decisions regarding required disclosure.

As of ~~June 30, 2020,~~March 31, 2021, or the Evaluation Date, our management, with the participation of our Principal Executive Officer and Principal Financial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our Principal Executive Officer and Principal Financial Officer have concluded based upon the evaluation described above that, as of ~~June 30, 2020,~~March 31, 2021 our disclosure controls and procedures were effective at the reasonable assurance level.

During the quarter ended ~~June 30, 2020,~~March 31, 2021, there ~~have been~~were no changes in our internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15(d)-15(f) promulgated under the Exchange Act, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

In the ordinary course of business, we are from time to time involved in lawsuits, claims, investigations, proceedings, and threats of litigation relating to intellectual property, commercial arrangements and other matters. “Item 3. Legal Proceedings” of our Annual Report on Form 10-K for the fiscal year ended December 31, ~~2019~~2020 includes a discussion of our current legal proceedings. ~~There have been no material changes~~Refer to Note 5 – Commitments and Contingencies in the accompanying Notes to the ~~matters described~~Condensed Consolidated Financial Statements in ~~those disclosures~~this Form 10-Q for further details on our legal proceedings during the three months ended ~~June 30, 2020, other than as set forth below.~~

The trial for the ANDA patent litigation against defendants, Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd., or, collectively, DRL, and Hikma Pharmaceuticals USA Inc., or Hikma, and certain of their respective affiliates, or the Defendants, took place in the United States District Court for the District of Nevada, or the Nevada Court (case no.: 2:16-cv-02525-MMD-NJK (consolidated with 2:16-cv-02562-MMD-NJK). Following conclusion of the trial in late January 2020, the Nevada Court, on March 30, 2020, decided in favor of the Defendants, ruling that our relevant patents are invalid due to obviousness. We have appealed this decision to the United States Court of Appeals for the Federal Circuit (case no.: 20-1723). We intend to vigorously enforce our intellectual property rights relating to VASCEPA, but we cannot predict the outcome of the appeal.

A settlement agreement with Apotex Inc., or Apotex, was reached in June 2020, that resolves patent litigation that would have resulted from the previously disclosed ANDA filed by Apotex with U.S. Food and Drug Administration, or FDA, and amended in May 2020, seeking approval of a generic form of VASCEPA capsules based on the MARINE study. As part of the settlement agreement, Apotex may not sell a generic version of VASCEPA in the United States until August 9, 2029 (the same such date provided for under the 2018 settlement agreement with Teva Pharmaceuticals USA, Inc., or Teva) or earlier under certain customary circumstances. As currently relevant, such circumstances include if we are not successful in our pending appeal of the March 2020 Nevada Court decision after issuance of the Federal Circuit mandate following any Federal Circuit rehearing or ~~en banc~~ ~~review.~~

This Quarterly Report on Form 10-Q contains forward-looking information based on our current expectations. Because our actual results may differ materially from any forward-looking statements that we make or that are made on our behalf, this section includes a discussion of important factors that could affect our actual future results, including, but not limited to, our ability to successfully commercialize VASCEPA, our capital resources, the progress and timing of our clinical programs, the safety and efficacy of our product candidates, risks associated with regulatory filings, the potential clinical benefits and market potential of our product candidates, commercial market estimates, future development efforts, patent protection, effects of healthcare reform, reliance on third parties effects of tax reform, and other risks set forth below.

Except those denoted below with a “*”, these risk factors have not been materially updated from our Annual Report on 10-K for the year ended December 31, ~~2019~~2020 filed with the SEC on February 25, ~~2020.~~2021, or our Annual Report.

Our business is subject to numerous risks and uncertainties that you should be aware of in evaluating our business. These risks include, but are not limited to, the following:

The summary risk factors described above should be read together with the text of the full risk factors below and in the other information set forth in our Annual Report and this Quarterly Report on Form 10-Q, including our consolidated financial statements and the related notes, as well as in other documents that we file with the SEC. If any such risks and uncertainties actually occur, our business, prospects, financial condition and results of operations could be materially and adversely affected. The risks summarized above or described in full below are not the only risks that we face. Additional risks and uncertainties not currently known to us, or that we currently deem to be immaterial may also materially adversely affect our business, prospects, financial condition and results of operations.

* We are substantially dependent upon VASCEPA, its commercialization in the United States and its development and commercialization in Europe and other major markets. In the United States, VASCEPA competes with a generic version of VASCEPA and we could experience increased generic competition in the near ~~term in light of a federal district court ruling in favor of the generic drug companies in our patent trial.~~term. In Europe, VAZKEPA only recently received approval for sale by applicable regulatory authorities and must also obtain relevant pricing approvals.

The success of our company depends on our ability to successfully commercialize our ~~sole~~only product, VASCEPA^® (icosapent ethyl) capsules, in major ~~markets. Our primary focus has been on the U.S. market as much~~markets globally. Much of our near-term financial results and value as a company ~~has~~had depended and currently depend on our ability to execute our development and commercial strategy for VASCEPA in the United States. ~~As previously disclosed, on March 30, 2020, following a trial, a federal district court ruled in favor~~A generic version of ~~the generic drug companies in our patent litigation against two filers of abbreviated new drug applications, or ANDAs, for our~~ VASCEPA franchise in the United States. We disagree with the ruling that our patents are invalid and are vigorously pursuing appeal. As detailed further below, if generic companies determine to launch generic versions of icosapent ethyllaunched in the United States ~~such~~in November 2020, and VASCEPA could face even more competition from generic companies in the United States in the near term in light of the patent litigation rulings against us in this territory. Sales of generic versions of VASCEPA could have a material and adverse impact on our revenues and ~~our~~ results of ~~operations.~~operations in the United States.

We ~~have expanded~~continue our development efforts to support regulatory approvals and launch of VASCEPA in major markets outside the United States, ~~primarily~~and in March 2021 we announced that the European Commission, or the EC, has approved the marketing authorization application for icosapent ethyl, under the ~~reduction~~brand name VAZKEPA, and hereafter along with VASCEPA, collectively referred to as VASCEPA, 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 factor. We must also obtain pricing approvals for VASCEPA in ~~high risk patients. This~~relevant jurisdictions in Europe, which process is complex and is conducted on a country-by-country basis.

Our expansion and development of VASCEPA outside the United States is generally not subject to the adverse patent ruling in the United States. Development outside the United States is primarily based on the second indication approval for VASCEPA in the United States, ~~and is an indication that is different than that which is subject,~~use of the drug in the ~~United States, to~~reduction of cardiovascular risk in select high-risk patients, which we believe has significantly more value potential.

We have been developing VASCEPA on our own in Europe for the ~~adverse patent litigation~~approved indication and are exploring possible strategic collaborations in ~~the United States.~~smaller markets within Europe and in other major markets. We currently have multiple partners for the development and commercialization of VASCEPA in select geographies and intend to consider potential additional partners to commercialize VASCEPA in other parts of the world. For example, we have strategic collaborations for the development and commercialization of VASCEPA in Canada, the Middle East and Greater China. ~~We are also currently developing VASCEPA on our own in Europe and are exploring possible strategic collaborations~~However, we cannot make any guarantees as to the success of these efforts,

~~within Europe~~ and ~~in other major markets. If~~if commercialization ~~efforts~~plans for VASCEPA do not meet expectations in major markets such as the United States and Europe, our business and prospects could be materially and adversely affected.

The development and commercial time cycle for VASCEPA or other products that we may develop from our research and development efforts could result in delays in our ability to achieve commercial success. For example, ~~only after years~~it took over a decade of preceding product development ~~in December 2019,~~before we ~~announced that the EMA validated our MAA seeking~~received marketing approval for ~~icosapent ethyl (brand name VASCEPA~~VAZKEPA in March 2021 from the ~~United States) as a treatment to reduce the risk of cardiovascular events in select high-risk patients.~~EC.

Likewise, if we seek to diversify our development programs or product offerings through licensing or acquisitions, such transactions are also time-consuming, may be dilutive to existing shareholdings, and can be disruptive to operations, and may not be available on favorable terms, or at all. These dynamics can restrict our ability to respond rapidly to adverse business conditions for VASCEPA. If development of, or demand for, VASCEPA does not meet expectations, we may not have the ability to effectively shift our resources to the development of alternative products, or do so in a timely manner, without suffering material adverse effects on our business. As a result, the lack of alternative markets and products we develop could constrain our ability to generate revenues and achieve profitability.

* As a result of the decision in favor of the two generic drug companies in connection with our ANDA patent trial, which ruling was upheld on appeal by a Federal Circuit panel, a generic version of VASCEPA has launched in the United States, and we could face further generic competition in the near term and our revenues and results of operations could be materially and adversely ~~affected if the generic companies were to receive final approval of their ANDAs, obtain adequate supply and launch one or more generic versions of VASCEPA in the United States.~~affected.

We ~~have~~ received paragraph IV certification notices from certain companies contending to varying degrees that certain of our patents are invalid, unenforceable and/or will not be infringed by the manufacture, use, sale or offer for sale of a generic form of VASCEPA as described in those companies’ ANDAs. Following receipt of the paragraph IV certifications, beginning in late 2017 we were involved in litigation against these companies, including Dr. Reddy’s Laboratories, Inc., or Dr. Reddy’s or DRL, and Hikma Pharmaceuticals USA Inc., or Hikma, (formerly known as West-Ward), and certain of their affiliates, or the Defendants, in the U.S. District Court for the District of Nevada, or the Nevada Court. In these lawsuits, we sought, among other remedies, an order enjoining each Defendant from marketing generic versions of VASCEPA before the last to expire of the asserted patents in 2030.

On March 30, 2020, following conclusion of ~~the~~a trial in late January 2020, the Nevada Court issued its ruling in favor of the Defendants. ~~The statutory stay on the FDA’s ability to give final~~On May 22, 2020 and August 10, 2020, Hikma and Dr. Reddy’s, respectively, received its U.S. FDA approval to market its generic versions of VASCEPA. On September 3, 2020, the U.S. Court of Appeals for the Federal Circuit, or the Federal Circuit, upheld the March ruling by the Nevada Court in favor of the two generic companies. On October 2, 2020, we filed a ~~generic VASCEPA associated~~combined petition for panel rehearing or rehearing en banc. On November 4, 2020, our rehearing and en banc petitions were denied. The mandate of the court was issued on November 12, 2020. On February 11, 2021, we filed a petition for a writ of certiorari with the ~~filing of these lawsuits expired~~United States Supreme Court to ask the Court to hear our appeal in ~~January 2020.~~this litigation, which is pending.

In November 2020, Hikma ~~received FDA approval of~~launched its ~~ANDA in May 2020. The FDA could approve DRL’s ANDA at any time. After FDA approval, subject to adequate supply, either company could commercially launch a~~ generic version of VASCEPA on a limited scale. On November 30, 2020, we filed a patent infringement lawsuit against Hikma affiliate for making, selling, offering to sell and importing generic icosapent ethyl capsules in and into the United ~~States.~~ States in a manner that we allege has induced the infringement of patents covering the use of VASCEPA to reduce specified cardiovascular risk. On January 25, 2021 we expanded the scope of this patent infringement lawsuit to include a health care insurance provider, Health Net, LLC.

Although, to date, no generics other than Hikma have been launched, in addition to ANDAs approved for Hikma and Dr. Reddy’s, on September 11, 2020, Teva Pharmaceuticals USA, Inc’s., or Teva’s, ANDA was approved by the U.S. Food and Drug Administration, or U.S. FDA. Apotex Inc., or Apotex, has applied for ANDA approval such application, based on public records, has not yet been approved. We intend to vigorously pursue these ongoing litigation matters, but cannot predict the outcomes or the impact on our business.

The ~~ruling of the Nevada Court~~court rulings detailed above could also permit each of Teva ~~Pharmaceuticals USA, Inc., or Teva,~~and Apotex to launch a generic version of VASCEPA under certain circumstances pursuant to a settlement agreement with us. For example, our settlement agreement with Teva provides that if another generic company obtains FDA approval and launches at risk pending appeal of the March 2020 Nevada Court ruling, Teva can launch its generic version of VASCEPA if we do not obtain an injunction removing such product from the market within 60 days. In such case, Teva’s commercialization would be at risk as Teva would be required to withdraw its product from the market if the other entities that launched at risk withdraw their products. Our settlement with Apotex Inc., or Apotex, does not have this provision. Further, the Teva and Apotex settlement agreements permit such companies to launch their generic version of VASCEPA ~~if we lose~~under royalty-free license from us given that our ~~appeal~~petition for en banc Federal Circuit review was not granted, after issuance of ~~the March 2020 Nevada Court decision at~~ the Federal Circuit ~~level. Like~~mandate on November 12, 2020. While Teva received U.S. FDA approval of its ANDA, any launch by Apotex would be subject to U.S. FDA approval of the Apotex ANDA and each generic launch is subject to procurement of adequate supply.

Once a generic version of VASCEPA is available in the market, whether based on a generic product with a MARINE indication label or REDUCE-IT indication label it ~~can be~~is typically used in many U.S. states to fill a prescription for any use of the ~~drug. The possibility~~drug, subject, in certain circumstances, to state reimbursement law, the potential for patent infringement under certain case law and subject to certain Teva and Apotex settlement agreement terms. We currently face generic competition from Hikma’s generic version of VASCEPA in the United States, and could face increased competition from additional generic ~~competition~~entrants in the near term, ~~could have, and any commercial launch of a generic version of VASCEPA into the market~~which could have a material and adverse impact on our revenues and our results of operations. There can be no assurance that we will be successful in preventing

use of generic versions of VASCEPA in indications for which they have not been approved by U.S. FDA, even if such use is determined to infringe certain of our patent claims.

Further, although we are ~~appealing the ruling of the Nevada Court, and may pursue additional~~pursuing available remedies, including ~~seeking~~ a ~~preliminary injunction pending~~petition for a writ of certiorari to ask the United States Supreme Court to hear our appeal, we may not be successful in any such efforts, which will be costly and time-consuming to pursue. Such efforts will also require considerable attention of management and could, even if ultimately successful, negatively impact our results of operations.

Additionally, ~~while~~ we believe that VASCEPA is difficult to manufacture and that building capacity to manufacture VASCEPA is time-consuming and ~~expensive, all of which may~~expensive. These factors limit the amount of VASCEPA supply available to generic companies, ~~in the event that they launch a generic version of VASCEPA, we could be wrong.~~as experienced by Hikma. We do not have direct visibility into the supply levels of any of the ~~ANDA filers~~generic company and we rely on our own experience together with information from third ~~parties.~~parties, which information may not be reliable. The ~~ANDA filers~~generic companies could potentially find or develop sources of qualified VASCEPA supply that are not known to us and that are more efficient or inexpensive than our sources. Furthermore, generic companies could potentially convince our suppliers to prioritize supply to the generic companies ahead of any applicable contractual commitments to supply us. While we anticipate that our suppliers will honor their commitments to us, if generic competitors are successful in gaining an advantage in the supply chain promotional and educational efforts, and potentially manufacture and supply, with respect to VASCEPA will suffer and consequentially VASCEPA prescriptions will likely decrease. In addition, we may need to litigate with such suppliers to protect our rights, which can be costly and distracting to management. Such circumstances could have a material and adverse impact on our revenues and results of operations directly in the United States and potentially outside of the United States as well if supply costs and availability are affected or promotion and education programs reduced.

* Factors outside of our control make it more difficult for VASCEPA to achieve a level of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary to meet expectations for commercial success.

In January 2013, we launched VASCEPA based on the U.S. ~~Food and Drug Administration, or~~ FDA, approval of our MARINE indication, for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe (TG >≥500 mg/dL) hypertriglyceridemia. Guidelines for the management of very high triglyceride levels suggest that the primary goal of reducing triglyceride levels in this patient population is reduction in the risk of acute pancreatitis. A secondary goal for this patient population is to reduce cardiovascular risk. The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined and our U.S. FDA-approved labeling and promotional efforts state ~~these facts.~~this fact.

In September 2018, we announced topline results from the ~~REDUCE-IT®~~REDUCE-IT^®, or Reduction of Cardiovascular Events with EPA—Intervention Trial cardiovascular outcomes study of VASCEPA. In November 2018, we announced the primary results of our REDUCE-IT cardiovascular outcomes study confirming 25% relative risk reduction for the topline primary endpoint result with multiple robust demonstrations of efficacy, including 20% reduction in cardiovascular death. REDUCE-IT was a multinational, prospective, randomized, double-blind, placebo-controlled study, enrollment for which started in November 2011. REDUCE-IT investigated the effects of VASCEPA on CV risk in statin-treated adults with well-controlled LDL-C 41-100 mg/dL (median baseline LDL-C: 75 mg/dL) and other CV risk factors, including persistent elevated TG 150-499 mg/dL (median baseline TG: 216 mg/dL). REDUCE-IT topline results showed the trial met its primary endpoint demonstrating an approximately 25% relative risk reduction, to a high degree of statistical significance (p<0.001), in MACE in the intent-to-treat patient population with use of VASCEPA 4 grams/day as compared to placebo. MACE events were defined as a composite of cardiovascular death, nonfatal myocardial infarction (MI), nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization. This result was supported by robust demonstrations of efficacy across multiple secondary endpoints. VASCEPA was well tolerated in REDUCE-IT with a safety profile generally consistent with clinical experience associated with omega-3 fatty acids and current U.S. FDA-approved labeling.

Despite U.S. FDA approval for this new indication and expanded label for VASCEPA, we may not meet expectations for market acceptance by physicians, patients, healthcare payors and others in the medical community for this new approved use, even if we are successful in our appeal ~~of the March 2020 ruling in the Nevada Court.~~effort. If VASCEPA does not achieve an adequate level of acceptance, we may not generate product revenues sufficient to become profitable on an ongoing basis. The degree of market acceptance of VASCEPA for its approved indications and uses or otherwise will depend on a number of factors, including:

For example, two major factors that affect market use of prescription drugs are their perceived cost-effectiveness and the breadth of their use among different patient populations, both on label and off-label. In October 2019, the Institute for Clinical and Economic Review, or ICER, released its final evidence report regarding clinical effectiveness and economic impacts on VASCEPA. The conclusion from the report is that VASCEPA easily met even the most stringent “commonly cited thresholds for cost-effectiveness and therefore represent(s) a high long-term value for money,” based on the organization’s value assessment framework. As part of the public meeting held by ICER analyzing REDUCE-IT data, the ICER review committee discussed whether, based on REDUCE-IT, VASCEPA should be considered for use in patients as an add-on to statin therapy generally, and not just in patients with persistent elevated triglyceride levels after statin therapy, which ICER defined as triglyceride levels of at least 135 mg/dL. Use as an add-on to statin therapy generally represents a larger patient population than studied in REDUCE-IT and larger than covered by U.S. FDA-approved labeling. By contrast, U.S. FDA-approved labeling for VASCEPA reflects limitations such as use in patients with persistent elevated triglyceride levels defined as triglyceride levels of at least 150 mg/dL after statin therapy and specific criteria designed to ensure the patient populations approved for use had sufficiently high degrees of CV risk. While the clinical judgment of prescribing physicians is the most important factor that determines the breadth of a drug’s use in the United States and often results in prescriptions in patient populations that go beyond U.S. FDA labeling, U.S. FDA-approved labeling that is more closely tied to the patient population studied in a clinical trial could limit use generally and by making reimbursement more difficult.

*The scale and scope of the ~~coronavirus, or~~ COVID-19 pandemic is uncertain and poses a significant threat to public health and infrastructure throughout the world, which could have a negative impact on our business.

The global spread of the coronavirus, the COVID-19, has created significant volatility, uncertainty and disruption in healthcare, social and economic infrastructures. The extent to which the coronavirus pandemic impacts our business, operations and financial results will depend on numerous evolving factors that we may not be able to accurately predict or plan around, including:

To comply with travel restrictions, social distancing, quarantines and other containment measures implemented in various geographies, in March 2020, we suspended field based face-to-face interactions. We resumed ~~sales force,~~on a limited basis field-based, face-to-face interactions with healthcare providers ~~on a pilot scale~~beginning in June 2020. AsDuring the ~~situation changes, we~~late part of the summer of 2020, substantially all of our field force personnel had the ability to resume face-to-face customer interactions, in a manner consistent with state and local guidance. In the fourth quarter of 2020 and in early 2021, the impact of COVID-19 worsened in much of the United States, with some healthcare professionals again limiting access to face-to-face interactions. Additionally, the number of patient visits to doctors’ offices and patients undergoing blood testing remains down considerably from pre-COVID-19 levels. These circumstances vary geographically and vary over time, with continued risk of resurgences in COVID-19 cases, and reinstitution of protocols, in various geographies. We hope to be able to ~~resume more~~maintain our substantial resumption of our business efforts, ~~but~~however, given the dynamics related to COVID-19, there can be no assurance that this will be ~~successful or that healthcare providers who~~the case. While we have ~~started to allow direct~~supplemented these face-to-face interactions with our sales force will continue to allow such interactions. In an effort to mitigate this disruption, we have implemented remote protocols and procedures to be able to support patient care and access of VASCEPA by providing digital and internet-based educational materials and copay cards. Although we expect such measures to be temporary, we cannot predict how long such measures will need to be in place. Thesevirtual outreach, these efforts may not be as ~~successful~~impactful as traditional, in-person ~~interactions, and are vulnerable~~

~~to disruptions that may occur if the digital infrastructures are insufficient to accommodate the increased usage as social distancing is implemented on a global scale. For example,~~interactions. Specifically, access to healthcare professionals through the internet isor other channels, may not be as productive as ~~interactions under prior conditions.~~in-person interactions.

Although we have a geographically diversified supply chain for VASCEPA and believe we have sufficient inventory on hand at pharmacies throughout the United States and other markets where it is approved for sale, and at various stages of manufacturing with our suppliers, the global spread of the outbreak and containment measures has been unprecedented and could have a negative impact on the availability of VASCEPA at various points in our supply chain, including limiting the ability of new suppliers to be inspected, which would have a material and adverse effect on our business.

The disruptions associated with the coronavirus pandemic could also delay the timing of a determination on our ~~patent ruling appeal and our~~ ability to seek ~~other~~ legal remedies as travel, operational resources and personnel are disrupted, with respect to our efforts and capabilities, as well as those of our advisors and the courts. The disruptions associated with the coronavirus pandemic could ~~also~~ delay ~~our~~the potential timing of subsequent steps for the launch of commercialization of VAZKEPA in Europe, including plans to hire additional employees for the potential commercialization of VASCEPA in Europe and could also delay the potential timing of completion of the EMA review and subsequent review of our application to get VASCEPA approved to be marketed in Europe. ~~For instance,~~Additionally, COVID-19 ~~appears~~could limit our ability to have ~~modestly slowed certain aspects~~access with healthcare professionals to help educate them regarding VAZKEPA so that they are more likely to prescribe it to their at-risk patients. And, similar to our experience in the United States, the effects of COVID-19 and social distancing considerations may reduce the ~~review with the overall timeline for the review being completed by the EMA shifting from what was previously estimated as late 2020 into our current estimate of early 2021.~~frequency at which at-risk patients seek non-urgent preventative medical care.

As with any cardiovascular outcomes trial, over time further data assessment related to REDUCE-IT by international regulatory authorities or otherwise could yield additional useful information to inform greater understanding of study outcome. If the additional data or related interpretations do not meet expectations, the perception of REDUCE-IT results and VASCEPA revenue potential may suffer and our stock price may decline.

In December 2019, the U.S. FDA approved a new indication and label expansion for VASCEPA as an adjunct to statin therapy to reduce the risk of MACE events in adult patients with elevated TG levels (≥150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease. Even though U.S. FDA has approved VASCEPA for this expanded label and new indication based on the REDUCE-IT results, additional data assessment by international regulatory authorities or otherwise could yield additional useful information to inform greater understanding of study outcome. Generally, trial data assessment sufficient to convey a complete picture of trial outcome can take years to complete and publish. When new data are assessed and released or presented it could exceed, match or may not meet investor expectations.

In addition, the same set of data can sometimes be interpreted to reach different conclusions. This was the case when Health Canada approved an indication based on REDUCE-IT data that was different in certain respects than that approved by U.S. FDA and by the EC in ~~the United States.~~Europe. It is possible the scope of subsequent regulatory approvals, if any, could likewise differ based on the same ~~data, such as with our pending European Union, or EU, application.~~data. Conflicting interpretations of data, or new data, could impact public and medical community perception of the totality of the efficacy and safety data from REDUCE-IT.

Regulatory authorities and medical guideline committees outside of the United States and the EU may consider the following additional factors, which could lead to evaluations of the totality of the efficacy and safety data from REDUCE-IT that differ from those of the ~~FDA:~~U.S. FDA or the EC:

If regulatory authorities and medical guideline committees outside of the United States and the EU draw conclusions that differ from those of the U.S. FDA or the EC, the U.S. FDA or the EC could reevaluate its conclusions as to the safety and efficacy of VASCEPA. Likewise, if additional data or analyses released from time to time do not meet expectations, the perception of REDUCE-IT results and the perceived and actual

value of VASCEPA may suffer. In these instances our revenue and business could suffer and our stock price could significantly decline.

* Ongoing clinical trials or new clinical data involving VASCEPA and similar moderate-to-high doses of eicosapentaenoic acid or icosapent ethyl could influence public perception of VASCEPA’s clinical profile and the commercial and regulatory prospects of VASCEPA.

Ongoing trials of moderate-to-high doses of VASCEPA and icosapent ethyl or a similar, eicosapentaenoic acid, product could provide further information on the effects of VASCEPA and its commercial and regulatory prospects.

The Effect of VASCEPA on Improving Coronary Atherosclerosis in People with High Triglycerides Taking Statin Therapy (EVAPORATE; ClinicalTrials.gov number, NCT02926027), is examining changes in patients’ coronary plaque over 9 to 18 months. The goal of this study is to evaluate whether treatment with VASCEPA (4 grams/day) results in a greater change from baseline in low attenuation plaque than placebo in subjects with elevated triglycerides (200-499 mg/dL). Entry criteria for EVAPORATE include: elevated triglycerides (fasting value between 200-499 mg/dL) at qualifying or baseline visit; LDL-C >40 mg/dL and LDL-C ≤115 mg/dL on appropriate statin therapy; stable diet and exercise, as defined as the same pattern for the previous four weeks; and stable treatment with a statin with or without ezetimibe for at least four weeks. In November 2019, interim data from the EVAPORATE study were presented showing a reduction in total plaque volume when compared with placebo, with no shown reduction of low attenuation plaque volume compared with placebo. This study is continuing as designed and final results are expected to be announced in the second half of 2020.

~~In addition,~~For example, the Randomized Trial for Evaluation in Secondary Prevention Efficacy of Combination Therapy–Statin and EPA (RESPECT-EPA; UMIN Clinical Trials Registry number, UMIN000012069), is a study examining Japanese patients with chronic

coronary artery disease receiving LDL-C lowering treatment by statin therapy. Patients will be randomized to either a control group (standard treatment) or EPA group (standard treatment plus 1.8 grams/day of eicosapentaenoic acid), to examine the effects of a different formulation of icosapent ethyl than VASCEPA on the incidence of cardiovascular events. The relationship between the ratio of EPA to arachidonic acid and incidence of events will also be examined. Results from this study are expected in the second half of 2021, but could be announced sooner or, due to delay related to COVID-19 or otherwise, later.

~~We are also completing our assessment of~~In November 2020, we announced statistically significant topline results from a Phase 3 clinical ~~study~~trial of VASCEPA, conducted by our partner in China, ~~similar in design to our MARINE study. We expect to announced~~Edding, which investigated VASCEPA as a treatment for patients with very high triglycerides (≥500 mg/dL). Even though such results ~~of that study in the second half of 2020. There can be no assurance that the results of this trial will be~~are similar to the results of the MARINE ~~study. Even if such results are similar~~study, additional clinical development efforts may be necessary in this market to demonstrate the effectiveness of VASCEPA in reducing major adverse cardiovascular events in Chinese patients with persistent cardiovascular risk.

We have also funded investigational studies on the use of VASCEPA in the ~~prevention and treatment~~setting of COVID-19 infection. On December 12, 2020, we announced at the National Lipid Association Scientific Sessions 2020 positive clinical results from the CardioLink-9 Trial, the first results of ~~which~~a study of VASCEPA in COVID-19 infected outpatients. Results from the other investigational studies are expected over the next year.

If the outcomes of one or more of these studies do not meet expectations, the perception of existing clinical results of VASCEPA, such as MARINE or REDUCE-IT, or the perceived clinical profile and commercial value of VASCEPA and its regulatory status may suffer. If this occurs our revenue and business could suffer and our stock price could significantly decline.

* Our current and planned commercialization efforts may not be successful in increasing sales of VASCEPA in the United ~~States and developing sales internationally.~~States.

It is estimated that over 25 million adults in the United States have elevated triglyceride levels ≥200 mg/dL and that more than 50 million adults in the United States have elevated triglyceride levels ≥150 mg/dL. Approximately two to three million adults in the United States have very high (≥~~500 mg/~~500mg/dL) triglyceride levels, the MARINE patient population. There are approximately 5five to 15 million people in the United States who meet the specific REDUCE-IT inclusion criteria. Since 1976, mean triglyceride levels have increased in concert with the growing epidemic of obesity, insulin resistance, and type 2 diabetes mellitus. In contrast, mean LDL-C levels have decreased. Prior to the REDUCE-IT results topline announcement in September 2018, our direct sales force consisted of approximately 170 sales professionals, including sales representatives and their managers. Based on the positive REDUCE-IT results, in early 2019, we increased the size of our sales force to approximately 440 sales professionals, including approximately 400 sales representatives. As a result of the ~~additional indication~~COVID-19 pandemic and ~~label expansion approved by~~ the ~~FDA~~related social distancing, in ~~December 2019,~~March 2020, we suspended face-to-face interactions between our sales representatives and healthcare professionals. We resumed on a limited basis field-based, face-to-face interactions with healthcare providers beginning in ~~cardiovascular risk reduction, we completed~~June 2020. During the ~~further expansion~~late part of the summer of 2020, substantially all of our ~~direct sales~~field force personnel were able to ~~approximately 900 sales professionals, including approximately 800 sales representatives. This sales team promotes VASCEPA to~~resume face-to-face customer interactions in a ~~limited group of physicians~~manner consistent with guidelines from local, state and ~~other healthcare professionals in select geographies~~government health officials in the United States. ~~Even after planned~~In the fourth quarter of 2020 and early 2021, the impact of COVID-19 worsened in much of the United States, with some physicians again limiting access to face-to-face interactions with our field force personnel. Accordingly, we have intentionally slowed the hiring of replacements for our open positions which resulted from ordinary turnover. As we witness our sales representatives increasingly able to resume direct interactions with healthcare professionals, we continually evaluate our needs and it is our intention to fill a significant number of these positions, provided such replacement is appropriate to meet our business needs. Thus, despite this significant expansion ~~this~~of our sales team, it is not large enough to call upon all ~~physicians. Thus, despite this significant expansion of our sales team,~~physicians and we may not have sufficient sales personnel and resources to maximize the sales potential of VASCEPA.

In addition to the sales force expansion in the United States, we plan to work internally and with partners to support regulatory efforts toward approvals and commercialization outside the United States based primarily on REDUCE-IT results. For example, assuming regulatory approval, we plan to launch VASCEPA on our own in at least certain geographies in Europe. As such efforts progress, we may encounter further challenges associated with rapidly hiring and training personnel and managing larger teams of people, directly or through our partners in jurisdictions in which management has less experience than in the United States.

~~Factors related to building and managing a sales and marketing organization in different territories world-wide that could inhibit our efforts to successfully commercialize VASCEPA, include:~~

If we are not successful in maintaining a sales force that is rightsized for our efforts to market and sell VASCEPA in the United States, our anticipated revenues or our expenses could be materially and negatively affected, and we may not obtain profitability, may need to cut back on research and development activities or implement other cost-containment measures, or we may need to raise additional funding that could result in substantial dilution or impose considerable restrictions on our business.

~~In response~~Although substantially all of our sales force personnel have the ability to ~~the COVID-19 pandemic, we announced~~resume face-to-face customer interactions in ~~March 2020 that face-to-face field sales and medical education activities would be temporary halted as~~ a safety measure, and as a result emphasis was placed on conducting these initiatives virtually. In June 2020, we subsequently announced that face-to-face field promotion and medical education activities would be resumed in a phased manner consistent with ~~guidance from local,~~ state and ~~government health officials. As of June 30, 2020, approximately 450 sales professionals have returned~~local guidance, given the dynamics related to the field in certain geographies and to varying degrees of access to meet with healthcare professionals and with the levels of such access changing regularly to sometimes be more or less restrictive. We intend to carefully monitor the evolution of the COVID-19, pandemic and may make further adjustments consistent with any changes in guidance from local, state and government health officials. It is anticipated that virtual interactions will be continued for the foreseeable future to complement face-to-face interactions. Additional promotional and educational initiatives are also inclusive of multi-channel consumer education campaigns. Therethere can be no assurance that ~~such~~we will be able to substantially resume or sustain our business efforts. While we have supplemented these face-to-face interactions with virtual ~~interactions~~outreach, these efforts may not be as successful as traditional, in-person interactions. Specifically, access to healthcare professionals through digital or other ~~promotional and educational initiatives will~~channels, may not be as ~~effective~~productive as in-person interactions.In the ~~promotion which was being conducted prior to restrictions resulting from COVID-19. In addition, areas of the country~~United States, in ~~which we have promoted VASCEPA the longest and have historically had the highest levels of reported prescriptions for~~

VASCEPA include cities and other densely populated areas which may be slower to resume direct interactions with our sales representatives and where patients may be more reluctant to resume visiting their healthcare providers for non-urgent medical care.

In July 2020 we launched our first ever ~~direct to~~direct-to- consumer promotional campaign regarding VASCEPA demonstrating results in lowering cardiovascular risk in patients with persistent cardiovascular risk in high risk patients. In September 2020, we launched a new, nationwide television advertisement in connection with our expanded promotional campaign which was further complemented by additional digital, point-of-care and other forms of healthcare professional and patient educational outreach. As the impact of COVID-19 on much of the United States worsened in the fourth quarter of 2020, we suspended television-based promotion of VASCEPA as we determined that the cost was not sufficiently justified in light of the COVID-19 pandemic on patient visits to doctors. We resumed a limited direct-to-consumer campaign in January 2021, including television-based promotion, digital and social media promotion to continue to grow consumer awareness of VASCEPA.There can be no assurance that such promotion will have the intended positive increase in patients asking their healthcare providers regarding VASCEPA or that prescription rates for VASCEPA will increase in the near future or at all from such promotion. Data on increased product usage from similar promotion of other products suggests that the impact of ~~television-based~~television-

based promotion can be positive and sustained but is rarely immediate in its effect. After assessing the scope, timing and pricing of generic competition, we may also decide to contract our VASCEPA promotional efforts.

* We have no experience in commercializing VASCEPA outside of the United States and may be unsuccessful in developing sales internationally.

While we have been working internally and with partners to support efforts toward approvals and commercialization outside the United States in light of the REDUCE-IT results and the recent EC approval of VAZKEPA, we may be unsuccessful in expanding our global footprint. For example, we plan to launch VAZKEPA on our own in the most commercially significant markets in Europe. The commercial launch of a new pharmaceutical product is a complex and resource heavy undertaking for a company to manage, and we have no prior experience as a company operating a commercial-stage pharmaceutical business in Europe. Given the amount of time and resources, including capital, needed to support regulatory and commercial efforts aimed at international expansion, if we are unsuccessful or delayed in generating revenues overseas, our results of operations could be materially and adversely impacted.

Factors that could inhibit our efforts to successfully commercialize VASCEPA include:

If we experience one or more of the setbacks described above, we may not be able to pursue international regulatory and commercial efforts in a cost effective manner, or at all, which could cause our stock price to decline.

* Our promotion of VASCEPA is subject to regulatory scrutiny and associated risk ~~generally and in connection with an ongoing U.S. government investigation.~~generally.

The Federal Food, Drug, and Cosmetic Act, or FDCA, has been interpreted by the U.S. FDA and the U.S. government to make it illegal for pharmaceutical companies to promote their U.S. FDA-approved products for uses that have not been approved by the U.S. FDA. Companies that market drugs for off-label uses or indications have been subject to related costly litigation, criminal penalties and civil liability under the FDCA and the False Claims Act. However, case law over the last several years has called into question the extent to which government in the United States, including the U.S. FDA, can, and is willing to seek to, prevent truthful and non-misleading speech related to off-label uses of U.S. FDA-approved products such as VASCEPA.

In May 2015, we and a group of independent physicians filed a lawsuit against the U.S. FDA seeking a federal court declaration that would permit us and our agents to promote to healthcare professionals the use of VASCEPA in the ANCHOR population and promote on the potential of VASCEPA to reduce the risk of cardiovascular disease so long as the promotion is truthful and non-misleading. This use of VASCEPA at issue reflected recognized medical practice at the time but was not approved by the U.S. FDA and was thus not covered by then U.S. FDA-approved labeling for the drug. Promotion of an off-label use has generally been

considered by the U.S. FDA to be illegal under the FDCA. The lawsuit, captioned Amarin Pharma, Inc., et al. v. Food & Drug Administration, et al., 119 F. Supp. 3d 196 (S.D.N.Y. 2015), was filed in the United States District Court for the Southern District of New York. In the lawsuit, we contended principally that U.S. FDA regulations limiting off-label promotion of truthful and non-misleading information are unconstitutional under the freedom of speech clause of the First Amendment to the U.S. Constitution as applied in the case of our proposed promotion of VASCEPA. The physicians in the suit regularly treated patients at risk of cardiovascular disease and, as the complaint contended, have First Amendment rights to receive truthful and non-misleading information from Amarin. The suit was based on the principle that ~~better-informed~~better informed physicians make better treatment decisions for their patients. The U.S. FDA opposed this lawsuit but did not dispute the veracity of the subject ANCHOR clinical trial data (the safety data from which was already and currently is in U.S. FDA-approved labeling of VASCEPA) or the peer-reviewed research related to VASCEPA and the potential for cardiovascular risk reduction.

In August 2015, we were granted preliminary relief in this lawsuit through the court’s declaratory judgment that confirmed we may engage in truthful and non-misleading speech promoting the off-label use of VASCEPA to healthcare professionals, i.e., to treat patients with persistently high triglycerides, and that such speech may not form the basis of a misbranding action under the FDCA. In August 2015, we began to communicate promotional information beyond the MARINE indication to healthcare professionals in the United States as permitted by this court declaration. The U.S. FDA did not appeal the court’s ruling. In March 2016, we settled this litigation under terms by which the U.S. FDA and the U.S. government agreed to be bound by the conclusions from the federal court order that we may engage in truthful and non-misleading speech promoting the off-label use of VASCEPA and that certain statements and disclosures that we proposed to make to healthcare professionals were truthful and non-misleading. As part of the settlement, given, as expressed in the court’s opinion, that the dynamic nature of science and medicine is that knowledge is ever-advancing and that a statement that is fair and balanced one day may become incomplete or otherwise misleading in the future as new studies are done and new data is acquired, we agreed that we bear the responsibility to ensure that our communications regarding off-label use of VASCEPA remain truthful and non-misleading, consistent with the federal court ruling.

While we believe we are now permitted under applicable law to more broadly promote VASCEPA, the U.S. FDA-approved labeling for VASCEPA did not change as a result of this litigation and settlement, and neither government nor other third-party coverage or reimbursement to pay for the off-label use of VASCEPA promoted under the court declaration was required. In addition to claims classically considered to be on-label based on our expanded label for VASCEPA based on the REDUCE-IT results, we proactively communicate information related to VASCEPA in a manner that we believe is truthful and non-misleading and thus protected under the freedom of speech clause of the First Amendment to the United States Constitution.

Promotional activities in the biotechnology and pharmaceutical industries generally are subject to considerable regulatory scrutiny and, even though we have the benefit of a final settlement in this litigation, our efforts may be subject to enhanced scrutiny to ensure that our promotion remains within the scope covered by the settlement. For example, under the settlement, we remain responsible for ensuring our speech is truthful and non-misleading, which is subject to a considerable amount of judgment. We, the U.S. FDA, the U.S. government, our competitors and other interested parties may not agree on the truthfulness and non-misleading nature of our promotional materials. Federal and state governments or agencies may also seek to find other means to prevent our promotion of unapproved truthful and non-misleading information about VASCEPA.

In June 2020, we received a civil investigative demand, or CID, from the U.S. Department of Justice, or the DOJ, informing us that the DOJ is investigating whether aspects of our promotional speaker programs and copayment waiver program during the period from January 1, 2015 to the present violated the U.S. Anti-Kickback Statute and the U.S. False Claims Act in relation to the sale and marketing of VASCEPA by us and our previous co-marketing partner, Kowa Pharmaceuticals America, Inc. Similarly, in March 2021, the United States Federal Trade Commission, or the FTC, issued a CID to us in connection with the FTC’s investigation of whether we have engaged in, or are engaging in, anticompetitive practices or unfair methods of competition relating to VASCEPA. The ~~CID requires~~CIDs require us to produce documents and answer written questions, or interrogatories, relevant to ~~the~~ specified time ~~period.~~periods. We ~~plan to cooperate~~are cooperating with the DOJ and ~~respond to the interrogatories and document requests of the CID.~~FTC, respectively. We cannot predict when ~~the investigation~~these investigations will be resolved, the outcome of the ~~investigation~~investigations or ~~its~~their potential impact on our business. Such investigations can be lengthy, costly and could materially affect and disrupt our business. If the government determines that we have violated the Anti-Kickback Statute and False Claims Act or antitrust regulations, we could be subject to significant civil and criminal fines and penalties.

If our promotional activities or other operations are found to be in violation of any law or governmental regulation through existing or new interpretations, we may be subject to prolonged litigation, penalties, including civil and criminal penalties, damages, fines and the curtailment or restructuring of our operations. Also, if governmental parties or our competitors view our claims as misleading or false, we could be subject to liability based on fair competition-based statutes, such as the Lanham Act. Any allegations that our promotional activities are not truthful or misleading, even allegations without merit, could cause reputational harm and adversely affect our ability to operate our business and our results of operations.

We may not be able to compete effectively against our competitors’ pharmaceutical products.

The biotechnology and pharmaceutical industries are highly competitive. There are many pharmaceutical companies, biotechnology companies, public and private universities and research organizations actively engaged in the research and development of products that may be similar to our product. It is probable that the number of companies seeking to develop products and therapies similar to our product will increase. Many of these and other existing or potential competitors have substantially greater financial, technical and human resources than we do and may be better equipped to develop, manufacture and market products. Should generic versions of VASCEPA be launched by third parties or us, our ability to afford market education to grow the market and maintain our current promotional efforts and attract favorable commercial terms in several aspects of our business will likely be adversely affected. These companies may develop and introduce products and processes competitive with, more efficient than or superior to ours. In addition, other technologies or products may be developed that have an entirely different approach or means of accomplishing the intended purposes of our products, which might render our technology and products noncompetitive or obsolete.

Our competitors both in the United States and abroad include large, well-established pharmaceutical and generic companies, specialty and generic pharmaceutical sales and marketing companies, and specialized cardiovascular treatment companies. With a generic version of VASCEPA launched by Hikma in November 2020 and further generic versions anticipated, it may not be viable for us to invest in market education to grow the United States market and our ability to maintain current promotional efforts and attract favorable commercial terms in several aspects of our business will likely be adversely affected as we face increased generic competition, or if we launch our own generic version of VASCEPA.

GlaxoSmithKline plc currently sells Lovaza^®, a prescription-only omega-3 fatty acid indicated for patients with severe hypertriglyceridemia, which was approved by U.S. FDA in 2004 and has been on the market in the United States since 2005. Multiple generic versions of Lovaza are available in the United States. Other large companies with competitive products include AbbVie, Inc., which currently sells Tricor^® and Trilipix^® for the treatment of severe hypertriglyceridemia and Niaspan^®, which is primarily used to raise high-density lipoprotein cholesterol, or HDL-C, but is also used to lower triglycerides. Multiple generic versions of Tricor, Trilipix and Niaspan are also available in the United States. We compete with these drugs, and in particular, multiple low-cost generic versions of these drugs, in our U.S. FDA-approved indicated uses, even though such products do not have U.S. FDA approval to reduce CV risk on top of statin therapy.

In addition, in May 2014, Epanova^® (omega-3-carboxylic acids) capsules, a free fatty acid form of omega-3 (comprised of 55% EPA and 20% DHA), was approved by the U.S. FDA for patients with severe hypertriglyceridemia. Epanova was developed by Omthera Pharmaceuticals, Inc., and is now owned by AstraZeneca Pharmaceuticals LP, or AstraZeneca. Also, in April 2014, Omtryg, another omega-3-acid fatty acid composition developed by Trygg Pharma AS, received U.S. FDA approval for severe hypertriglyceridemia. Neither Epanova nor Omtryg have been commercially launched, but could launch at any time. AstraZeneca has greater resources than we do, including financial, product development, marketing, personnel and other resources.

AstraZeneca ~~had been conducting~~conducted a long-term outcomes study to assess Statin Residual Risk Reduction With EpaNova in HiGh Cardiovascular Risk PatienTs With Hypertriglyceridemia (STRENGTH). The study iswas a randomized, double-blind, placebo-controlled (corn oil), parallel group design that is believed to have enrolled approximately 13,000 patients with hypertriglyceridemia and low HDL and high risk for cardiovascular disease randomized 1:1 to either corn oil plus statin or Epanova plus statin, once daily. On January 13, 2020 following the recommendation of an independent Data Monitoring Committee, AstraZeneca decided to close the STRENGTH trial due to its low likelihood of demonstrating benefit to patients with mixed dyslipidemia who are at increased risk of cardiovascular disease. ~~AstraZeneca also stated that full~~Full data from the STRENGTH trial ~~will be~~was presented at ~~a future medical meeting.~~the American Heart Association’s Scientific Sessions in November 2020, confirming that Epanova failed to meet the primary endpoint of CV risk reduction. In addition, in March 2017, Kowa Research Institute (a subsidiary of the Japanese company Kowa Co., Ltd) initiated a Phase 3 cardiovascular outcomes trial titled PROMINENT examining the effect of pemafibrate (experimental name K-877) in reducing cardiovascular events in Type II diabetic patients with hypertriglyceridemia. Kowa Research Institute has publicly estimated study completion in May 2022, and if successful, U.S. regulatory approval is estimated in mid-2023.

During 2018, two outcomes studies were completed of omega-3 mixtures which both failed to achieve their primary endpoints of cardiovascular risk reduction and two meta-analyses were published showing that omega-3 mixtures of both EPA and DHA are not effective in lowering

cardiovascular risk. Results of these failed outcomes studies and analysis, while not done with VASCEPA, may negatively affect sales of VASCEPA. For example, results of VITamin D and OmegA-3 TriaL (VITAL), as announced immediately before the presentation of REDUCE-IT results at the 2018 Scientific Sessions of the AHA on November 10, 2018, failed to achieve its primary endpoint of lowering cardiovascular events. VITAL was an NIH funded randomized double-blind, placebo-controlled, 2x2 factorial trial of 2000 IU per day of vitamin D3 and 1 gram per day of omega-3 fatty acid mixture supplementation (Lovaza) for the primary prevention of cancer and cardiovascular disease in a nationwide USA cohort of 25,874 adults not selected for elevated cardiovascular or cancer risk.

Likewise, in 2018, results from A Study of Cardiovascular Events iN Diabetes (ASCEND) trial were released and showed negligible results for omega-3 fatty acid mixtures 1 gram daily. ASCEND was a British Heart Foundation funded 2x2 factorial design, randomized study to assess whether aspirin 100 mg daily versus placebo and separately, omega-3 fatty acid mixtures 1 gram daily versus placebo, reduce the risk of cardiovascular events in a nationwide UK cohort of over 15,000 individuals with diabetes who do not have atherosclerotic cardiovascular disease. In 2020, an additional Nordic trial known as OMEMI failed to demonstrate a

reduction in cardiovascular events with an omega-3 fatty acid mixture. OMEMI, an investigator-initiated, multi-center, randomized clinical trial, was designed to evaluate the effects of daily treatment with omega-3 fatty acids compared with placebo among elderly patients (ages 70-82) with recent myocardial infarction. Patients received 1.8 g omega-3 fatty acids (930 mg EPA and 660 mg DHA) or placebo (corn oil) daily added to standard of care. Results presented in November 2020 at the American Heart Association’s Scientific Sessions showed no significant differences in cardiovascular events between the treatment groups for the composite primary endpoint (non-fatal MI, unscheduled revascularization, stroke, hospitalization for heart failure or all-cause mortality), nor for the individual components of this endpoint after 2 years.

In a meta-analysis, presented in 2018 by the Cochrane Foundation and separately as published in JAMA, additional omega-3 studies were evaluated. Similar to the VITAL and ASCEND studies, most of the studies in these omega-3 meta-analyses were of omega-3 mixtures, including DHA, and most were studies of relatively low doses of omega-3 as is associated with dietary supplementation and/or they studied relatively low risk patient populations. The exception was the JELIS study, conducted in Japan, of highly pure EPA which showed a positive outcome benefit but had significant limitations in its application to a wider population. The negative results from such omega-3 mixture studies could create misleading impressions about the use of omega-3s generally, including VASCEPA, despite REDUCE-IT positive results and the ~~highly pure~~highly-pure and stable EPA active ingredient in VASCEPA and its higher dose regimen.

We are also aware of other pharmaceutical companies that are developing products that, if successfully developed, approved and marketed, would compete with VASCEPA. It is not fully clear at this time what the impact of COVID-19 will be on each of these programs. Acasti Pharma, or Acasti, a subsidiary of Neptune Technologies & Bioresources Inc., announced in December 2015 that it intends to pursue a regulatory pathway under section 505(b)(2) of the FDCA for its omega-3 prescription drug candidate, CaPre^®(omega-3 phospholipid), derived from krill oil, for the treatment of hypertriglyceridemia. In September 2016, Acasti announced positive results from its pivotal bioavailability bridging study comparing CaPre to Lovaza, establishing a scientific bridge between the two that is expected to support the feasibility of a 505(b)(2) regulatory pathway. In the first quarter of 2018, Acasti initiated a Phase 3 clinical program (TRILOGY 1 & 2) to assess the safety and efficacy of CaPre in patients with very high (≥500 mg/dL) triglycerides. In January 2020, Acasti announced topline results of the TRILOGY 1 trial of CaPre. The study did not reach statistical significance and further analysis in underway. In April 2020, Acasti announced that it filed a meeting request with the FDA to discuss the TRILOGY 1 data and align on the interpretation of the results. Acasti also will seek FDA input on revisions to the pre-specified TRILOGY 2 statistical analysis plan, or SAP, and on a plan for pooling the data from TRILOGY 1 and TRILOGY 2 in support of an NDA filing. Acasti stated that it received a written response from the FDA in June 2020 confirming that the FDA will require pivotal efficacy analyses for TRILOGY 2 to be performed on the full Intent to Treat population as per the original SAP and supporting Acasti’s conduct of exploratory post-hoc analyses in TRILOGY 1, depending on the outcome of TRILOGY 2.

~~Accordingly, Acasti may be required to conduct an additional clinical trial before submitting an NDA. Acasti also stated that they expect to announce topline results of TRILOGY 2 at the end of August.~~ ~~NDA submission (if any) and resultant review/approval timelines will be announced following~~ ~~completion of TRILOGY 1 and 2 data analysis.~~ We believe Micelle BioPharma Inc., or Micelle, is also developing potential treatments for hypertriglyceridemia based on omega-3 fatty acids. To our knowledge, Micelle, after acquiring SC401 from Sancilio & Company, or Sancilio, is pursuing a regulatory pathway under section 505(b)(2) of the FDCA for its product and submitted an Investigational New Drug Application, or IND, in July 2015. Micelle (Sancilio) completed two pharmacokinetic studies and Phase 2 bioavailability studies (FASTR I&II), with one comparing SC401 to Lovaza. We expect the company or a potential partner to initiate a pivotal clinical Phase 3 study as the next step in development.

Matinas BioPharma, Inc., or Matinas, is developing an omega-3-based therapeutic, ~~(MAT9001)~~MAT9001, for the treatment of severe hypertriglyceridemia and mixed dyslipidemia. In the fourth quarter of 2014 Matinas filed an IND with the U.S. FDA to conduct a human study in the treatment of severe hypertriglyceridemia and, in June 2015, the company announced topline results for its head-to-head comparative short duration pharmacokinetic and pharmacodynamic study of MAT9001 versus VASCEPA in patients under conditions inconsistent with the U.S. FDA-approved label for VASCEPA and presented results based on biomarker modification without outcomes data. In September 2017, Matinas announced that it will be seeking a partner company to develop and commercialize MAT9001. In March 2019, Matinas announced that net proceeds from a public offering of common stock would be used for development activities for MAT9001. In March 2020, Matinas announced that it completed the clinical dosing for a comparative clinical bridging bioavailability study and the in-life portion of a 90-day comparative toxicology ~~study in the first quarter of 2020.~~study. Both studies were conducted to support a planned 505(b)(2) registration pathway. In March, Matinas also initiated an additional Phase 2 head-to-head pharmacokinetic and pharmacodynamic study (ENHANCE-IT) against VASCEPA in patients with elevated triglycerides (150-499 mg/dL), while the study was paused in the first quarter of 2020 due to the COVID-19 ~~pandemic. Matinas expects to resume~~pandemic, enrollment resumed in June ~~2020, with topline data expected~~and was completed in August 2020. In the first quarter of ~~2021.~~ 2021, Matinas ~~anticipates holding an End-of-Phase 2~~

~~meeting with~~announced topline results from the ~~FDA~~ENHANCE-IT study, stating that LYPDISO, or MAT9001, did not meet statistical significance over VASCEPA on the primary endpoint of percent change from baseline to end of treatment in triglycerides in the ~~third quarter~~pharmacodynamic, or PD, population. A key secondary endpoint in ENHANCE-IT was the measurement of ~~2020~~eicosapentaenoic acid levels in the blood, which is regarded as a key surrogate marker in determining cardiovascular risk reduction. In ENHANCE-IT, plasma EPA concentrations were significantly higher with LYPDISO vs. VASCEPA (46% relative percent increase in the change from baseline EPA level vs VASCEPA). Matinas stated that the results from ENHANCE-IT suggest tpotential for LYPDISO as a drug for cardiovascular risk reduction and announced that it is pursuing external partnerships to ~~discuss these data as well as~~further develop LYPDISO for cardiovascular outcomes indication. As a result, Matinas no longer plans to pursue an indication for the ~~protocol for a Phase 3 registration trial~~treatment of ~~MAT9001 in patients with severe hypertriglyceridemia.~~sever hypertriglyceridemia, instead focusing on the broader cardiovascular risk reduction indication.

In June 2018, ~~Gemphire Therapeutics (renamed~~ NeuroBo Pharmaceuticals, Inc. ~~following completion of a merger on December 31, 2019)~~(then-named Gemphire Therapeutics) announced positive topline results from a Phase 2b trial (INDIGO-1) of its drug candidate, gemcabene, in patients with severe hypertriglyceridemia. Gemcabene is an oral, once-daily pill for a number of hypercholesterolemic populations and severe hypertriglyceridemia. In August 2018, the U.S. FDA requested that Gemphire conduct an additional long-term toxicity study before commencing any further clinical testing, thereby effectively placing gemcabene on clinical hold. In March 2020 NeuroBo announced the completion of the requested studies, and in May 2020 the company announced that it received written communication from the U.S. FDA that the clinical development program for Gemcabene remains on partial clinical hold. In June 2019, Gemphire announced top-line clinical results from a Phase 2 trial in Familial Partial Lipodystrophy (FPL)/NASH in which Gemcabene safely met the primary endpoint in a sub-set of patients. Phase 3 studies for homozygous familial ~~hypercholesterolemia~~hypercholesterol emia (HoFH), heterozygous familial hypercholesterolemia (HeFH) and non-familial hypercholesterolemia in ASCVD patients are planned.

Afimmune Ltd. has an oral, small molecule drug candidate, epeleuton (DS-102), in development for a number of conditions of the liver, lung, and metabolic system, including hypertriglyceridemia and cardiovascular risk reduction, Phase 2 clinical trials are currently ongoing for non-alcoholic fatty liver disease, or NAFLD, chronic obstructive pulmonary disease, or COPD, and planned for hypertriglyceridemia and Type 2 diabetes (TRIAGE), in the United States. In November 2019, Afimmune Ltd. announced positive results from an exploratory Phase 2 study of epeleuton in patients with NAFLD in which the molecule decreased triglycerides, improved glycemic control, and decreased markers of inflammation. In August 2020, Afimmune reported Ph2a study results of epeleuton in patients with NAFLD. Although epeleuton failed to meet the primary endpoint to demonstrate effects on liver enzyme elevation, it demonstrated significant reduction of triglycerides, HbA1c and potential for CV risk reduction. In September 2020, Afimmune announced the start of TRIglyceride And Glucose control with Epeleuton in Metabolic Syndrome Patients, or TRIAGE, a Phase IIb study of epeleuton in patients with high triglycerides and type 2 diabetes to assess the safety and efficacy of orally administered epeleuton capsules vs placebo in the treatment of hypertriglyceridemia and type 2 diabetes. Results are expected in the fourth quarter of 2021.

Based on prior communications from the U.S. FDA, including communications in connection with its review of the ANCHOR indication for VASCEPA, it is our understanding that the U.S. FDA is not prepared to approve any therapy for treatment of cardiovascular risk based on biomarker modification without cardiovascular outcomes study data, with the exception of therapies which lower LDL-cholesterol, depending on the circumstances. In particular, it is our understanding that the U.S. FDA is not prepared to approve any therapy based primarily on data demonstrating lowering of triglyceride levels. In our view, this position from the U.S. FDA did not change based on the REDUCE-IT study particularly in light of significant independence of the positive benefit demonstrated in the REDUCE-IT study from triglyceride levels and benefit from the REDUCE-IT study supporting that the positive effects of VASCEPA are unique to VASCEPA and extend beyond triglyceride reduction. If the U.S. FDA were to change this position, it could potentially have a negative impact on Amarin by making it easier for other products to achieve a cardiovascular risk reduction indication without the need in advance to conduct a long and expensive cardiovascular outcomes study.

* GenericVASCEPA also faces competition from dietary supplement manufacturers marketing omega-3 products as nutritional supplements. Such products are classified as food, not as prescription drugs or as over-the-counter drugs, by the U.S. FDA in the United States. Most regulatory regimes outside the United States are similar in this regard. Some of the promoters of such products have greater resources than us and are not restricted to the same standards as are prescription drugs with respect to promotional claims or manufacturing quality, consistency and subsequent product stability. We have taken successful legal action against supplement manufacturers attempting to use the REDUCE-IT results to promote their products. Still, we cannot be sure physicians and pharmacists will view the U.S. FDA-approved, prescription-only status, and EPA-only purity and stability of VASCEPA or U.S. FDA’s stringent regulatory oversight, as significant advantages versus omega-3 dietary supplements regardless of clinical study results and other scientific data.

In March 2021, we announced that the EC has approved the marketing authorization application for VAZKEPA to reduce the risk of cardiovascular events in certain high-risk, statin treated adult patients. With the approval by the EC of VAZKEPA, there is currently no other drug that is approved for cardiovascular risk reduction in Europe in the at-risk patient population studied in REDUCE-IT. In addition, there is currently no other direct competition for Canada and the Middle East. However, consistent with the U.S., our competitors include large, well-established pharmaceutical companies, specialty and generic pharmaceutical companies, marketing companies, and specialized cardiovascular treatment companies.

Recent CV outcomes trials and meta-analyses with low and high dose omega-3 fatty acid mixtures containing DHA have not shown substantial benefit in patients receiving contemporary medical therapy, including statins. Due to failed low dose omega-3 CV outcomes trials, the European regulatory authorities have concluded that omega-3 fatty acid medicines (specifically Lovaza^®/Omacor^®) at a dose of 1-gram per day are not effective in preventing further events for patients who have had a heart attack. The STRENGTH trial of an omega-3 mixture studied at 4-grams per day also failed to demonstrate cardiovascular benefit.

In addition, VAZKEPA also faces competition from dietary supplement manufacturers marketing omega-3 productions as nutritional supplements. In Europe, such products are classified as food, not as prescription drugs or as over-the-counter drugs.

As generic company competitors ~~are seeking FDA approval of generic versions~~seek to compete with copies of VASCEPA in the United ~~States. We are pursuing an appeal of a March 2020 federal court decision that declared as invalid a group of patents that protect our exclusivity in the United~~ States and elsewhere we could face additional challenges to our patents and additional patent ~~litigation related to another group of patents related to FDA approval of a REDUCE-IT-based indication.~~litigation.

The FDCA, as amended by the Drug Price Competition and Patent Term Restoration Act of 1984, as amended, or the Hatch-Waxman Amendments, permits the U.S. FDA to approve ANDAs for generic versions of brand name drugs like VASCEPA. We refer to the process of generic drug applications as the “ANDA process.” The ANDA process permits competitor companies to obtain marketing approval for a drug product with the same active ingredient, dosage form, strength, route of administration, and labeling as the approved brand name drug, but without having to conduct and submit clinical studies to establish the safety and efficacy of the proposed generic product. In place of such clinical studies, an ANDA applicant needs to submit data demonstrating that its product is bioequivalent to the brand name product, usually based on pharmacokinetic studies.

As an alternate path to U.S. FDA approval for modifications of products previously approved by the U.S. FDA, an applicant may submit a new drug application, or NDA, under Section 505(b)(2) of the FDCA (enacted as part of the Hatch-Waxman Amendments). This statutory provision permits the filing of an NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference from the owner of the data. The Hatch-Waxman Amendments permit the applicant to rely upon the U.S. FDA findings of safety and effectiveness of a drug that has obtained U.S. FDA approval based on preclinical or clinical studies conducted by others. In addition to relying on U.S. FDA prior findings of safety and effectiveness for a referenced drug product, the U.S. FDA may require companies to perform additional preclinical or clinical studies to support approval of the modification to the referenced product.

If an application for a generic version of a branded product or a Section 505(b)(2) application relies on a prior U.S. FDA finding of safety and effectiveness of a previously-approved product including an alternative strength thereof, the applicant is required to certify to the U.S. FDA concerning any patents listed for the referenced product in the U.S. FDA publication called “Approved Drug Products with Therapeutic Equivalence Evaluations,” otherwise known as the “Orange Book.” Specifically, the applicant must certify in the application that:

The Hatch-Waxman Amendments require an applicant for a drug product that relies, in whole or in part, on the U.S. FDA’s prior approval of VASCEPA, to notify us of its application, a “paragraph IV” notice, if the applicant is seeking to market its product prior to the expiration of the patents that both claim VASCEPA and are listed in the Orange Book. A bona fide paragraph IV notice may not be given under the Hatch-Waxman Amendments until after the generic company receives from the U.S. FDA an acknowledgement letter stating that its ANDA is sufficiently complete to permit a substantive review.

The paragraph IV notice is required to contain a detailed factual and legal statement explaining the basis for the applicant’s opinion that the proposed product does not infringe our patents, that the relevant patents are invalid, or both. After receipt of a valid notice, the branded product manufacturer has the option of bringing a patent infringement suit in federal district court against any generic company seeking approval for its product within 45 days from the date of receipt of each notice. If such a suit is commenced within this 45-day period, the Hatch-Waxman Amendments provide for a 30-month stay on U.S. FDA’s ability to give final approval to the proposed generic product, which period begins on the date the paragraph IV notice is received. Generally, during a period of time in which generic applications may be submitted for a branded product based on a product’s regulatory exclusivity status, if no patents are listed in the Orange Book before the date on which a complete ANDA application for a product (excluding an amendment or supplement to the application) is submitted, an ANDA application could be approved by U.S. FDA without regard to a stay. For products entitled to five-year exclusivity status, the Hatch-Waxman Amendments provide that an ANDA application may be submitted after four years following U.S. FDA approval of the branded product if it contains a certification of patent invalidity or non-infringement to a patent listed in the Orange Book. In such a case, the 30-month stay runs from the end of the five-year exclusivity period. Statutory stays may be shortened or lengthened if either party fails to cooperate in the litigation and it may be terminated if the court decides the case in less than 30 months. If the litigation is resolved in favor of the ANDA applicant before the expiration of the 30-month period, the stay will be immediately lifted and the U.S. FDA’s review of the application may be completed. Such litigation is often time-consuming and costly, and may result in generic competition if such patents are not upheld or if the generic competitor is found not to infringe such patents.

In ~~September and October 2016, we received paragraph IV certification notices from four companies contending~~addition to ~~varying degrees that certain of our patents are invalid, unenforceable and/or will not be infringed by~~ the manufacture, use, sale or offer for sale of a generic form of the 1-gram dose strength of VASCEPA as described in those companies’ ANDAs. These certifications were expected given the eligibility for submission of ANDAs under the NCE regulatory structure, after the expiration of four years from the July 2012 approval of VASCEPA.

We filed patent infringement lawsuits against three of these four ANDA applicants, which filings were based on the MARINE study. In October 2016, Amarin filed a lawsuit against Roxane Laboratories, Inc. and related parties, collectively, Roxane, in the U.S. District Court for the District of Nevada. The case against Roxane was captioned ~~Amarin Pharma, Inc. et al. v. Roxane Laboratories, Inc. et al., Civ. A. No. 2:16-cv-02525 (D. Nev.).~~ According to a stipulation filed with the Nevada Court, in December 2016, Roxane transferred its ANDA to West-Ward Pharmaceuticals International Limited, which then designated West-Ward Pharmaceuticals Corp. (or together with West-Ward Pharmaceuticals International Limited, or West-Ward and now known as Hikma) as its agent for FDA communications. In view of the ANDA transfer, in February 2017, West-Ward replaced Roxane and related parties as Defendants in the above-referenced case. The case against West-Ward was captioned ~~Amarin Pharma, Inc. et al. v. West-Ward Pharmaceuticals Corp. et al., Civ. A. No. 2:16-cv-02525 (D. Nev.).~~ In November 2016, Amarin filed a lawsuit against Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd., collectively, DRL, and, together with Hikma and their respective affiliates involved in the litigations, or the Defendants, in the Nevada Court. The case against DRL was captioned ~~Amarin Pharma, Inc. et al. v. Dr. Reddy’s Laboratories, Inc. et al~~., Civ. A. No. 2:16-cv-02562 (D. Nev.). In November 2016, Amarin filed a lawsuit against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals Industries Limited, or collectively, Teva, in the Nevada Court. The case against Teva was captioned ~~Amarin Pharma, Inc. et al. v. Teva Pharmaceuticals USA, Inc. et al~~., Civ. A. No. 2:16-cv-02658. In all three lawsuits, we were seeking, among other remedies, an order enjoining each defendant from marketing generic versions of the 1-gram dose strength of VASCEPA before the last to expire of the asserted patents in 2030. The three lawsuits were consolidated for pretrial proceedings.

In October 2016, we introduced to the market a 0.5-gram dose strength of VASCEPA. In August 2017, as anticipated, we received a paragraph IV certification notice from Teva contending that certain of our patents are invalid, unenforceable and/or will not be infringed by the manufacture, use, sale or offer for sale of a generic form of the 0.5-gram dose strength of VASCEPA, as described in the Teva ANDA. This Teva ANDA was filed as an amendment to the 1-gram Teva ANDA and is related to patents already at issue in the 1-gram VASCEPA patent litigation. This certification followed the related listing in the Orange Book of patents associated with

the 0.5-gram product in June 2017. This June 2017 listing was within the five-year, post NDA-approval period during which the Hatch-Waxman Amendments require a paragraph IV certification of patent invalidity or non-infringement under the Hatch-Waxman, five-year, NCE regulatory scheme. Accordingly, in October 2017, we filed a patent infringement lawsuit against Teva in the Nevada Court. The case was captioned ~~Amarin Pharma, Inc.~~ ~~et al.~~ ~~v. Teva Pharmaceuticals USA, Inc.~~ ~~et al.~~, Civ. A. No. 2:17-cv-2641 (D. Nev.). In this lawsuit, we sought, among other remedies, an order enjoining Teva from marketing generic versions of the 0.5-gram dose strength of VASCEPA before the last to expire of the asserted patents in 2030.

In July 2018, we received a paragraph IV certification notice from DRL contending that certain of our patents are invalid, unenforceable and/or will not be infringed by the manufacture, use, sale or offer for sale of a generic form of the 0.5-gram dose strength of VASCEPA, as described in the DRL ANDA. This DRL ANDA was filed as an amendment to the 1-gram DRL ANDA and is related to patents already at issue in the 1-gram VASCEPA patent litigation. This certification followed the related listing in the Orange Book of patents associated with the 0.5-gram product in June 2017. This June 2017 listing was within the five-year, post NDA-approval period during which the Hatch-Waxman Amendments require a paragraph IV certification of patent invalidity or non-infringement under the Hatch-Waxman, five-year, NCE regulatory scheme. Accordingly, in August 2018, we filed a patent infringement lawsuit against DRL in the Nevada Court. The case was captioned ~~Amarin Pharma, Inc. et al. v. Dr. Reddy’s Laboratories, Inc. et al~~., Civ. A. No. 2:18-cv-01596 (D. Nev.). In this lawsuit, we sought, among other remedies, an order enjoining DRL from marketing generic versions of the 0.5-gram dose strength of VASCEPA before the last to expire of the asserted patents in 2030. In light of the overlap between the cases, DRL and Amarin have stipulated that the final judgment on the merits of the parties’ contentions in the consolidated 1-gram action shall also be binding in the 0.5-gram case. Amarin and Hikma have agreed similarly with respect to Hikma’s proposed 0.5-gram capsule product.

~~On May 24, 2018, we entered into a settlement agreement with Teva that resolves our~~ ANDA patent litigation as it relates to Teva’s as amended ANDA for both the 1-gram and 0.5-gram dose strengths of VASCEPA. As part of this settlement agreement, Teva may first begin selling its generic version of VASCEPA in the United States on August 9, 2029, or earlier under certain customary circumstances, including commercial launch by another generic manufacturer under certain circumstances.

On March 30, 2020, the Nevada Court issued its ruling in favor of the Defendants (DRL and Hikma). On May 22, 2020, Hikma received FDA approval to market its generic version of VASCEPA. To date, Hikma has not launched a generic version of VASCEPA. We are pursuing an appeal of the decision and may pursue additional remedies, including seeking a preliminary injunction against a generic product launch. We can make no guarantees as to the success, timing or efforts involved in connection with such appeal, or a preliminary injunction ifdescribed above, we determine to pursue it, including that we would be able to successfully recover any damages for patent infringement even if we were to appear on appeal. In light of the FDA’s approval of its ANDA, Hikma can launch a generic version of VASCEPA, subject to having qualified supply available and elects to launch at risk during the appeal process, DRL’s ANDA could ~~similarly be approved at any time. Generic competition from one or both such companies in the near term could have a material and adverse impact on our revenues and our stock price.~~

The ruling of the Nevada Court could also permit Teva to launch a generic version of VASCEPA under certain circumstances pursuant to a settlement agreement with us. For example and as discussed above, the settlement agreement provides that if another generic company obtains FDA approval and launches at risk pending appeal of the March 2020 Nevada Court ruling, Teva can commercialize a generic version of VASCEPA if we do not obtain an injunction removing such product from market within 60 days. Further, the settlement agreement permits Teva to commercialize a generic version of VASCEPA if we ultimately lose our appeal of the March 2020 Nevada Court decision at the Federal Circuit.

The fourth ANDA applicant referenced above is Apotex Inc., or Apotex, which sent us a paragraphs III and IV certification notice in September 2016. A settlement agreement with Apotex was reached in June 2020 that resolves patent litigation that would have resulted from the ANDA filed by Apotex with the FDA and amended in May 2020 seeking approval of a generic form of VASCEPA. As part of the settlement agreement, Apotex may not sell a generic version of VASCEPA in the United States until August 9, 2029 (the same such date provided for under the 2018 settlement agreement with Teva) or earlier under certain customary circumstances. As currently relevant, such circumstances include if Amarin is not successful in its pending appeal of the March 2020 Nevada Court decision after issuance of the Federal Circuit mandate following any Federal Circuit rehearing or ~~en banc~~ ~~review.~~

~~We expect to~~ face ~~similar~~ patent litigation related to the patents filed in the Orange Book related to the REDUCE-IT study. ~~In addition, a~~A three-year period of exclusivity under the Hatch-Waxman Amendments is generally granted for a drug product that contains an active moiety that has been previously approved, such as when the application contains reports of new clinical investigations (other than bioavailability studies) conducted by the sponsor that were essential to approval of the application. Accordingly, we received three-year exclusivity in connection with the approval of our sNDA for REDUCE-IT study results. Such three-year exclusivity protection precludes, unless otherwise agreed, the U.S. FDA from approving a marketing application for an ANDA, a product candidate that the U.S. FDA views as having the same conditions of approval as VASCEPA (for example, the same indication and/or other conditions of use), or a 505(b)(2) NDA submitted to the U.S. FDA with VASCEPA as the reference product until December 13, 2022, three years from the date of U.S. FDA approval of the REDUCE-IT sNDA. While this three-year exclusivity would generally prevent such an approval based on our

REDUCE-IT indication during such time, it does not preclude tentative or final approval of an ANDA based on our MARINE indication. The U.S. FDA may accept and commence review of such REDUCE-IT-related applications during the three-year exclusivity period. Such three-year exclusivity grant does not prevent a company from challenging the validity of REDUCE-IT patents during such period. This three-year form of exclusivity may also not prevent the U.S. FDA from approving an NDA that relies only on its own data to support the change or innovation. Regulatory exclusivity is in addition to exclusivity afforded by issued patents related to VASCEPA.

We may also face challenges to the validity of our patents through a procedure known as inter partes review. Inter partes review is a trial proceeding conducted through the Patent Trial and Appeal Board, of the U.S. Patent and Trademark Office. Such a proceeding could be introduced against us within the statutory one-year window triggered by service of a complaint for infringement related to an ANDA filing or at any time by an entity not served with a complaint. Such proceedings may review the patentability of one or more claims in a patent on specified substantive grounds such as allegations that a claim is obvious on the basis of certain prior art.

We intend to vigorously enforce our intellectual property rights relating to VASCEPA, but we cannot predict the outcome of the pending lawsuits, any appeals, or any subsequently filed lawsuits or inter partes review.

Generally, if an ANDA filer meets the approval requirements for a generic version of VASCEPA to the satisfaction of the U.S. FDA under its ANDA, U.S. FDA may grant tentative approval to the ANDA during a Hatch-Waxman 30-month stay period and during the Hatch-Waxman 36-month regulatory exclusivity period. A tentative approval is issued to an ANDA applicant when its application is approvable prior to the expiration of any exclusivities applicable to the branded, reference listed drug product. A tentative approval does not allow the applicant to market the generic drug product and postpones the final ANDA approval until applicable exclusivity protections have expired.

The statutory NCE-related 30-month stay triggered by the 1-gram dose patent litigation following generic application submissions permitted on July 26, 2016 expired on January 26, 2020, seven-and-a-half years from our initial FDA approval of VASCEPA. Now that the Nevada Court has issued a decision in the MARINE-related patent litigation in favor of the Defendants and the FDA has approved the Hikma ANDA, we are at greater risk of a launch from the Defendants, which could then permit a similar launch by Teva under our settlement agreement earlier than the agreed-upon August 9, 2029 date noted above. Although we are pursuing an appeal of the Nevada Court’s decision, the timing of such appeal proceedings and an outcome on the merits is difficult to predict. It is not uncommon for such an appeal to take from several months to approximately one year from the notice of appeal until judgment, which timing could be protracted in light of the disruptions caused by the coronavirus pandemic. Although we may file an expedited motion for an injunction to prevent any generic launch while our appeal is pending, such motion may require that we post a bond to secure generics’ lost profits in the event that generics prevail on appeal, which bond and damages amount may be significant. There can be no guarantee we would be successful in any of such efforts.

~~Once a generic version~~Generic versions of VASCEPA ismade available in the market, ~~whether~~even if based on a ~~generic product with a~~ MARINE indication ~~label or REDUCE-IT indication label, it can be~~only are often used to fill a prescription for any intended use of the drug. If ~~final approval of a generic~~any approved ANDA ~~(like Hikma’s recently approved ANDA) is granted and an ANDA filer is~~filers are able to supply the product in significant commercial quantities, ~~unless we pursue and are successful with preliminary injunction efforts,~~ generic companies could introduce generic versions of VASCEPA in the market, ~~including~~as Hikma did in ~~the near term.~~November 2020, although on a limited scale. Although any such introduction of a generic version of VASCEPA would also be subject to ~~current~~any litigation settlement terms and patent infringement claims (including any new claims and those that may then be subject to an ~~appeal,~~appeal), pursuing such ~~claims~~litigation may be prohibitively costly or could put a substantial constraint on our resources.

Any significant degree of generic market entry would limit our U.S. sales, which would have a significant adverse impact on our business and results of operations. In addition, even if a competitor’s effort to introduce a generic product is ultimately unsuccessful, the perception that such development is in progress and/or news related to such progress could materially affect the reputation of VASCEPA or the perceived value of our company and our stock price. For example, our stock price suffered a significant decline following our announcement of the Nevada Court’s ruling in favor of the ~~Defendants.~~Defendants and the Federal Circuit ruling upholding the Nevada Court’s ruling. In addition, generic market entry, whether limited to its approved indication or not, can create market disruption which leads to an overall slowing of market growth regardless of whether the net price of the generic entry is higher or lower than the net price of the branded drug. Such disruption includes potential stock shortages of the generic market entry at retail pharmacies and wholesalers which can cause filling of prescriptions for patients to be delayed or abandoned. Sponsors of generic entries typically do not fund market education initiatives to help healthcare professionals and at-risk patients learn about a new drug, which, particularly for a recently launched drug, can potentially limit overall growth. And certain States impose restrictions on the promotion of branded drugs, particularly if the generic market entry is less expensive than the branded drug. While some companies with generic competition elect to launch an authorized generic form of the drug to counter the perception, real or imagined, that generics are less expensive, if launched, an authorized generic is typically aligned with reduction or elimination of promotion of the associated branded drug limiting the extent of market growth and potentially contracting the overall size of the realized market penetration such that, while an authorized generic could be profitable the market opportunity for growth from an authorized generic is likely less than from promotion of a branded drug and we have not launched an authorized generic version of VASCEPA.

55* The active pharmaceutical ingredient in VASCEPA is difficult and time consuming to manufacture, often requires considerable advanced planning and long-term financial commitments to ensure sufficient capacity is available when needed and, perhaps not surprisingly, is reportedly in short supply to our generic competitors, one of which has filed a lawsuit against us claiming we have engaged in anticompetitive practices related to our building of adequate supply for our needs and, in activities we believe were prompted by the generic competitor, government agencies are investigating our business as it relates to the supply of the active pharmaceutical ingredient in VASCEPA. This dynamic could interfere with our business plans.

The active pharmaceutical ingredient in VASCEPA is difficult and time consuming to manufacture, often requires considerable advanced planning and long-term financial commitments to ensure sufficient capacity is available when needed. We have invested over a decade to develop with individual members of our third-party, active pharmaceutical ingredient supply chain the technical knowhow, manufacturing processes and related regulatory approvals that have helped enable our suppliers to supply our clinical and commercial needs globally. Based on statements made by Hikma and Dr. Reddy’s, the active pharmaceutical ingredient of VASCEPA needed to manufacture their generic versions of VASCEPA is in short supply to them. We believe this may be due to their lack of adequate planning, knowhow and expertise regarding this fragile active ingredient.

As has been a practice in the generic pharmaceutical industry, on April 27, 2021, Dr. Reddy’s filed a complaint against us in the United States District Court District of New Jersey (case no. 2:21-cv-10309) alleging various antitrust violations stemming from alleged anticompetitive practices related to the supply of active pharmaceutical ingredient of VASCEPA. Damages sought include recovery for alleged economic harm to Dr. Reddy’s, payors, and consumers, treble damages and other costs and fees. Injunctive relief against the alleged violative activities is also being sought by Dr. Reddy’s. Such litigation can be lengthy, costly and could materially

* affect and disrupt our business. We believe we have valid defenses and will vigorously defend against the claims but cannot predict the outcome.

We have also received a civil investigative demand from the U.S. Federal Trade Commission and a subpoena from the New York Attorney General with respect to practices relating to our supply of the active pharmaceutical ingredient in VASCEPA. We believe such contact from the governments may have been prompted by a generic competitor. We are cooperating with the agencies. The government inquiries require us to produce documents and answer related questions relevant to specified time periods. Such investigations can be lengthy, costly and could materially affect and disrupt our business. We cannot predict when these investigations will be resolved, the outcome of the investigations or their potential impact on our business. If a government determines that we have violated antitrust law, we could be subject to significant civil fines and penalties.

VASCEPA is a prescription-only omega-3 fatty acid product. Omega-3 fatty acids are also marketed by other companies as non-prescription dietary supplements. As a result, in the U.S. VASCEPA is subject to non-prescription competition and consumer substitution.

Our only product, VASCEPA, is a prescription-only form of EPA, an omega-3 fatty acid in ethyl ester form. Mixtures of omega-3 fatty acids in triglyceride form are naturally occurring substances contained in various foods, including fatty fish. Omega-3 fatty acids are marketed by others in a number of chemical forms as non-prescription dietary supplements. We cannot be sure physicians and other providers will view the pharmaceutical grade purity and proven efficacy and safety of VASCEPA as having a superior therapeutic profile to unproven and loosely regulated omega-3 fatty acid dietary supplements. In addition, the U.S. FDA has not yet enforced to the full extent of its regulatory authority what we view as illegal claims made by certain omega-3 fatty acid product manufacturers to the extent we believe appropriate under applicable law and regulations, for example, claims that certain of such chemically altered products are dietary supplements and that certain of such products reduce triglyceride levels or could reduce cardiovascular risk.

Also, for over a decade, subject to certain limitations, the U.S. FDA has expressly permitted dietary supplement manufacturers that sell supplements containing the omega-3 fatty acids EPA and/or DHA to make the following qualified health claim directly to consumers: Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. Such companies are not, however, permitted, based on U.S. FDA enforcement activity, to make claims that suggest or imply treatment of cardiovascular disease.

These factors enable dietary supplements to compete with VASCEPA to a certain degree. Although we have taken steps to address these competitive issues, and plan to continue to do so vigorously, we may not be successful in such efforts.

For example, on October 29, 2018, Amarin filed two lawsuits in U.S. federal court, each against a different dietary supplement company for unlawfully using the results from the REDUCE-IT cardiovascular outcomes study to falsely and deceptively claim that their omega-3 dietary supplement products are effective in reducing cardiovascular risk. The defendants in the cases were Omax Health, Inc., or Omax, and The Coromega Company, Inc., or Coromega. In April 2019, based on the strength of our case and available legal remedies, Omax and Coromega settled these litigations under terms by which Omax and Coromega agreed to substantially all the demands in Amarin’s complaints. Under the settlements, Coromega and Omax agreed to publicly correct their prior statements that wrongly suggested the REDUCE-IT cardiovascular outcomes trial supports the safety and efficacy of omega-3 dietary supplements. Each dietary supplement company also acknowledged that as a general matter under federal law dietary supplements may be lawfully marketed to supplement the diet, but they cannot be lawfully marketed to treat, mitigate, or prevent disease, such as cardiovascular disease.

Similarly, on August 30, 2017, Amarin filed a lawsuit with the United States International Trade Commission, or the ITC, against manufacturers, importers, and distributors of products containing synthetically produced omega-3 products in ethyl ester or re-esterified triglyceride form that contain more EPA than DHA or any other single component for use in or as dietary supplements. The lawsuit sought an investigation by the ITC regarding potentially unfair methods of competition and unfair acts involving the importation and sale of articles in the United States that injure or threaten injury to a domestic industry. In October 2017, the ITC determined to not institute our requested investigation. We appealed this determination to the U.S. Federal Circuit, but that court upheld ITC’s determination. On July 30, 2019, we filed a petition with the U.S. Supreme Court seeking to appeal the Federal Circuit decision, which petition was denied on December 9, ~~2019.~~2019, ending this litigation. We have also engaged with U.S. FDA on the topic of synthetically produced omega-3 products through the citizen’s petition process and otherwise.

In addition, to the extent the net price of VASCEPA after insurance and offered discounts is significantly higher than the prices of commercially available omega-3 fatty acids marketed by other companies as dietary supplements (through that lack of coverage by insurers or otherwise), physicians and pharmacists may recommend these ~~commercial~~retail alternatives instead of writing or filling prescriptions for VASCEPA or patients may elect on their own to take commercially available omega-3 fatty acids. Also, insurance plans may increasingly impose policies that directly or indirectly favor supplement use over VASCEPA. While VASCEPA is priced comparatively with, or in some cases lower than, many competing treatments, particularly when taking into account insurance

coverage, such pricing might not be sufficient for healthcare providers or patients to elect VASCEPA over alternative treatments that may be perceived as less expense or more convenient to access. If healthcare providers or patients favor dietary supplements over prescribing VASCEPA, we may be constrained in how we price our product of VASCEPA’s market acceptance may be less than expected, which would have a negative impact on our revenues and results of operations.

The commercial value to us of sales of VASCEPAoutside the United States may be smaller than we ~~anticipate.~~anticipate, including adequacy of product reimbursement such as in Europe, which can vary from country to country resulting in potential patient access restrictions.

There can be no assurance as to the adequacy for commercial success of VASCEPA outside the United States. For example, ~~even if we obtain~~despite having received EC approval to commercialize ~~VASCEPA~~VAZKEPA in Europe orand as we ~~and Eddingpharm~~expect to obtain, through our partner Edding, marketing approval for VASCEPA in Mainland China, Hong Kong, Macau and Taiwan, or the China Territory, applicable regulatory agencies may impose restrictions on the

product’s conditions for use, distribution or marketing and in some cases may impose ongoing requirements for post-market surveillance, post-approval studies or clinical trials.

~~Also, there~~Further, securing adequate reimbursement is ~~a degree~~critical for commercial success of ~~unpredictability with regard to the eventual~~any therapeutic and pricing and reimbursement levels of medications in markets outside the United ~~States.~~States can be unpredictable and vary considerably on a country-by-country basis. In some foreign countries, including ~~Canada and~~ major markets in Europe, the pricing of prescription pharmaceuticals is subject to governmental control. In these countries, pricing negotiations with individual governmental authorities can take six to 12 months or longer after the receipt of regulatory marketing approval for a product. The time required to secure reimbursement tends to vary from country to country and cannot be reliably predicted at this time. In certain European countries, securing product reimbursement is a requisite to commercial launch. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a pharmacoeconomic study that compares the cost-effectiveness of VASCEPA to other available therapies. Such pharmacoeconomic studies can be costly and the results uncertain. Our business could be harmed if reimbursement of our products is unavailable or limited in scope or amount or if pricing is set at unsatisfactory levels. If the pricing and reimbursement levels of VASCEPA are lower than we anticipate, then affordability of, and market access to, VASCEPA may be adversely affected and thus market potential in these territories would suffer.

We or our partners may even choose to not proceed with marketing VASCEPA in a market, even after a regulatory approval, due to negative commercial dynamics. ~~Furthermore,~~Further, with regard to any indications for which we may gain approval in territories outside the United States, the number of actual patients with the condition included in such approved indication may be smaller than we anticipate. ~~Further,~~In addition, we could face competition from products similar or deemed equivalent to VASCEPA in various jurisdictions through regulatory pathways that are more lenient than in the United States or in jurisdictions in which we do not have exclusivity from regulations or intellectual property. If any of these market dynamics exist, the commercial potential in these territories for our product would suffer.

* Our products and marketing efforts are subject to extensive post-approval government regulation.

Once a product candidate receives U.S. FDA marketing approval, numerous post-approval requirements apply. Among other things, the holder of an approved NDA is subject to periodic and other monitoring and reporting obligations enforced by the U.S. FDA and other regulatory bodies, including obligations to monitor and report adverse events and instances of the failure of a product to meet the specifications in the approved application. Application holders must also submit advertising and other promotional material to regulatory authorities and report on ongoing clinical trials.

With respect to sales and marketing activities, advertising and promotional materials must comply with U.S. FDA rules in addition to other applicable federal and local laws in the United States and in other countries. The result of our First Amendment litigation and settlement may cause the government to scrutinize our promotional efforts or otherwise monitor our business more closely. Industry-sponsored scientific and educational activities also must comply with U.S. FDA and other requirements. In the United States, the distribution of product samples to physicians must comply with the requirements of the U.S. Prescription Drug Marketing Act. Manufacturing facilities remain subject to U.S. FDA inspection and must continue to adhere to the U.S. FDA’s pharmaceutical current good manufacturing practice requirements, or cGMPs. Application holders must obtain U.S. FDA approval for product and manufacturing changes, depending on the nature of the change.

We also are subject to the federal transparency requirements under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively the ACA, enacted in March 2010, which require manufacturers of certain drugs, devices, biologics, and medical supplies to report to the Centers for Medicare & Medicaid Services, or CMS, information related to payments and other transfers of value to physicians and teaching hospitals and physician ownership and investment interests. We may also be subject, directly or indirectly through our customers and partners, to various fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute, U.S. False Claims Act, and similar state laws, which impact, among other things, our proposed sales, marketing, and scientific/educational grant programs. We participate in the U.S. Medicaid Drug Rebate Program, the Federal Supply Schedule, or FSS, of the U.S. Department of Veterans Affairs, or the VA, and other government drug programs, and, accordingly, are subject to complex laws and regulations regarding reporting and payment

obligations. We must also comply with requirements to collect and report adverse events and product complaints associated with our products. Our activities are also subject to U.S. federal and state consumer protection and unfair competition laws, non-compliance with which could subject us to significant liability. Similar requirements exist in many of these areas in other countries.

Depending on the circumstances, failure to meet post-approval requirements can result in criminal prosecution, fines or other penalties, injunctions, recall or seizure of products, total or partial suspension of production, denial or withdrawal of pre-marketing product approvals, or refusal to allow us to enter into supply contracts, including government contracts. We may also be held responsible for the non-compliance of our partners, such as our former co-promotion partner Kowa Pharmaceuticals America, Inc. ~~For example,~~As discussed above, in June 2020, we received a civil investigative demand, or CID, from the U.S. Department of Justice, or the DOJ, informing us that the DOJ is investigating whether aspects of our promotional speaker programs and copayment waiver programs during the period from January 1, 2015 to the present violated the U.S. Anti-Kickback Statute and the U.S. False Claims Act in relation to the sale ~~of sale~~ and marketing of VASCEPA by us and our previous co-marketing partner, Kowa Pharmaceuticals America, Inc. The CID requires us to produce documents and answer written questions, or interrogatories, relevant to the specified time period. We ~~plan to cooperate~~are cooperating with the ~~DOJ and respond to the interrogatories and document requests of the CID.~~DOJ. We cannot predict when the investigation will be resolved, the outcome of the investigations or its potential impact on our business. Such investigations can be lengthy, costly and could materially affect and disrupt our business. If the government determines that we have violated the Anti-Kickback Statute and False Claims Act, we could be subject to significant civil and criminal fines and penalties. In addition, even if we comply with U.S. FDA and other requirements, new information regarding the safety or effectiveness of a product could lead the U.S. FDA to modify or withdraw a product approval. Newly discovered or developed safety or effectiveness data may require changes to a drug’s approved labeling and marketing, including the addition of new warnings and contraindications, and also may require the implementation of other risk management measures. Adverse regulatory action, whether pre- or post-approval, can potentially lead to product liability claims and increase our product liability exposure. We must also compete against other products in qualifying for coverage and reimbursement under applicable third-party payment and insurance programs.

In addition, all of the above factors may also apply to any regulatory approval for VASCEPA obtained in territories outside the United States. In Europe, for example, restrictions regarding off-label promotion are in some ways more stringent than in the United States, including restrictions covering certain communications with shareholders. Given our inexperience with marketing and commercializing products outside the United States, in certain territories we may need to rely on third parties, such as our partners in Canada, China and the Middle East, to assist us in dealing with any such ~~issues.~~issues and we will have limited or no control over such partners.

Legislative or regulatory reform of the healthcare system in the United States and foreign jurisdictions may affect our ability to profitably sell VASCEPA.

Our ability to commercialize our future products successfully, alone or with collaborators, will depend in part on the extent to which coverage and reimbursement for the products will be available from government and health administration authorities, private health insurers and other third-party payors. The continuing efforts of the U.S. and foreign governments, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce healthcare costs may adversely affect our ability to set prices for our products which we believe are fair, and our ability to generate revenues and achieve and maintain profitability.

Specifically, in both the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes to the healthcare system in ways that could affect our ability to sell our products profitably. For example, on August 2, 2011, the Budget Control Act of 2011, among other things, created the Joint Select Committee on Deficit Reduction to recommend to Congress proposals for spending reductions. The Joint Select Committee did not achieve a targeted deficit reduction, which triggered the legislation’s automatic reductions. In concert with subsequent legislation, this has resulted in aggregate reductions to Medicare payments to providers of, on average, 2% per fiscal year through 2030 unless Congress takes additional action. These cuts reduce reimbursement payments related to our products, which could potentially negatively impact our revenue. However, these Medicare sequester reductions ~~will be~~have been suspended ~~from May 1, 2020~~ through December 31, ~~2020~~2021 due to the COVID-19 pandemic. Also for example, the ACA has substantially changed the way healthcare is financed by both governmental and private insurers and has significantly impacted the U.S. pharmaceutical industry. Among other cost-containment measures, the ACA establishes:

There has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices. Specifically, there have been several recent U.S. Congressional inquiries and proposed federal and state legislation designed

to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs. On July 24, 2020 and September 13, 2020, President Trump announced several executive orders related to prescription drug pricing that seek to implement several of the administration’s proposals. In response, the U.S. FDA released a final rule on September 24, 2020, which went into effect on November 30, 2020, providing guidance for states to build and submit importation plans for drugs from Canada. Further, on November 20, 2020 CMS issued an Interim Final Rule implementing the Most Favored Nation, or MFN, Model under which Medicare Part B reimbursement rates will be calculated for certain drugs and biologicals based on the lowest price drug manufacturers receive in Organization for Economic Cooperation and Development countries with a similar gross domestic product per capita. The ~~Trump administration~~MFN Model regulations mandate participation by identified Part B providers and will apply in all U.S. states and territories for a seven-year period beginning January 1, 2021 and ending December 31, 2027. The Interim Final Rule has not been finalized and is ~~currently assessing additional proposals~~subject to revision and challenge. On December 28, 2020, a judge in the U.S. District Court for the Northern District of California granted a preliminary injunction prohibiting CMS from implementing the MFN rule pending completion of the comment and rulemaking process required under the Administrative Procedures Act. On January 13, 2021, in a separate lawsuit brought by industry groups in the U.S. District of Maryland, the government defendants entered a joint motion to stay litigation on the condition that ~~are~~the government would not appeal the preliminary injunction granted in the U.S. District Court for the Norther District of California and that the performance for any final regulation stemming from the MFN Interim Final Rule shall not commence earlier than 60 days after publication of that regulation in the Federal Register. Further, authorities in Canada have passed rules designed to ~~affect~~safeguard the Canadian drug ~~pricing, such as tying U.S. drug prices to prices outside the United States. Congress~~supply from shortages. If implemented, importation of drugs from Canada and the ~~Trump~~MFN Model may materially and adversely affect the price we receive for any of our products and product candidates. On November 20, 2020, HHS finalized a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law. The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers. Pursuant to an order entered by the U.S. District Court for the District of Columbia, the portion of the rule eliminating safe harbor protection for certain rebates related to the sale or purchase of a pharmaceutical product from a manufacturer to a plan sponsor under Medicare Part D has been delayed to January 1, 2023. Further, implementation of this change and new safe harbors for point-of-sale reductions in price for prescription pharmaceutical products and pharmacy benefit manager service fees are currently under review by the Biden administration ~~have each~~and may be amended or repealed. Although a number of these and other proposed measures may require authorization through additional legislation to become effective, and the Biden administration may reverse or otherwise change these measures, Congress has indicated that it will continue to seek new legislative ~~and/or administrative~~ measures to control drug costs. At the state level, legislatures have increasingly passed

legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. For example, the State of California enacted legislation that requires notice for exceeding specified limits on annual drug price increases and other legislation that seeks to limit the use of co-pay cards in certain situations.

In addition, it is time-consuming and expensive for us to go through the process of seeking coverage and reimbursement from Medicare and private payors. Our products may not be considered cost effective, and government and third-party private health insurance coverage and reimbursement may not be available to patients for any of our future products or sufficient to allow us to sell our products on a competitive and profitable basis. Our results of operations could be adversely affected by ACA and by other healthcare reforms that may be enacted or adopted in the future. In addition, increasing emphasis on managed care in the United States will continue to put pressure on the pricing of pharmaceutical products. For example, proposals are being considered to expand the use of dietary supplements in addition to or in place of drugs in government and private payor plans. In addition, cost control initiatives could decrease the price that we or any potential collaborators could receive for any of our future products and could adversely affect our profitability.

These and similar regulatory dynamics, including the recent entry of a generic version of VASCEPA into the market, and the potential for additional generic version in the near term, canaffect our ability to commercialize VASCEPA on commercially reasonable terms and limit the commercial value of VASCEPA.

If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.

We participate in the Medicaid Drug Rebate program, the 340B drug pricing program, and the VA’s FSS pricing program. Under the Medicaid Drug Rebate program, we are required to pay a rebate to each state Medicaid program for our covered outpatient drugs that are dispensed to Medicaid beneficiaries and paid for by a state Medicaid program as a condition of having federal funds being made available to the states for our drugs under Medicaid and Medicare Part B. Those rebates are based on pricing data reported by us on a monthly and quarterly basis to CMS, the federal agency that administers the Medicaid Drug Rebate program. These data include the average manufacturer price and, in the case of innovator products, the best price for each drug which, in general, represents the lowest price available from the manufacturer to any entity in the U.S. in any pricing structure, calculated to include all

sales and associated rebates, discounts and other price concessions. Our failure to comply with these price reporting and rebate payment obligations could negatively impact our financial results.

The ACA made significant changes to the Medicaid Drug Rebate program. CMS issued a final regulation, which became effective on April 1, 2016, to implement the changes to the Medicaid Drug Rebate program under the ACA. The issuance of the final regulation has increased and will continue to increase our costs and the complexity of compliance, has been and will continue to be time-consuming to implement, and could have a material adverse effect on our results of operations, particularly if CMS challenges the approach we take in our implementation of the final regulation.

Federal law requires that any company that participates in the Medicaid Drug Rebate program also participate in the Public Health Service’s 340B drug pricing program in order for federal funds to be available for the manufacturer’s drugs under Medicaid and Medicare Part B. The 340B program requires participating manufacturers to agree to charge statutorily defined covered entities no more than the 340B “ceiling price” for the manufacturer’s covered outpatient drugs. These 340B covered entities include a variety of community health clinics and other entities that receive health services grants from the Public Health Service, as well as hospitals that serve a disproportionate share of low-income patients. The 340B ceiling price is calculated using a statutory formula based on the average manufacturer price and Medicaid rebate amount for the covered outpatient drug as calculated under the Medicaid Drug Rebate program, and in general, products subject to Medicaid price reporting and rebate liability are also subject to the 340B ceiling price calculation and discount requirement. Any additional future changes to the definition of average manufacturer price and the Medicaid rebate amount under the ACA, other legislation, or in regulation could affect our 340B ceiling price calculations and negatively impact our results of operations.

The Health Resources and Services Administration, or HRSA, which administers the 340B program, issued a final regulation regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties on manufacturers that knowingly and intentionally overcharge covered entities, which became effective on January 1, 2019. It is currently unclear how HRSA will apply its enforcement authority under the new regulation. We also are required to report our 340B ceiling prices to HRSA on a quarterly basis. Implementation of the civil monetary penalties regulation and the issuance of any other final regulations and guidance could affect our obligations under the 340B program in ways we cannot anticipate. In addition, legislation may be introduced that, if passed, would further expand the 340B program to additional covered entities or would require participating manufacturers to agree to provide 340B discounted pricing on drugs used in the inpatient setting.

Pricing and rebate calculations vary across products and programs, are complex, and are often subject to interpretation by us, governmental or regulatory agencies and the courts. In the case of our Medicaid pricing data, if we become aware that our reporting for a prior quarter was incorrect, or has changed as a result of recalculation of the pricing data, we are obligated to resubmit the corrected data for up to three years after those data originally were due. Such restatements and recalculations increase our costs for complying with the laws and regulations governing the Medicaid Drug Rebate program and could result in an overage or underage in our rebate liability for past quarters. Price recalculations also may affect the ceiling price at which we are required to offer our products under the 340B program or could require us to issue refunds to 340B covered entities.

Significant civil monetary penalties can be applied if we are found to have knowingly submitted any false pricing information to CMS, or if we fail to submit the required price data on a timely basis. Such conduct also could be grounds for CMS to terminate our Medicaid drug rebate agreement, in which case federal payments may not be available under Medicaid or Medicare Part B for our covered outpatient drugs. Significant civil monetary penalties also can be applied if we are found to have knowingly and intentionally charged 340B covered entities more than the statutorily mandated ceiling price. We cannot assure you that our submissions will not be found by CMS or HRSA to be incomplete or incorrect.

In order to be eligible to have our products paid for with federal funds under the Medicaid and Medicare Part B programs and purchased by certain federal agencies and grantees, as noted above, we participate in the VA’s FSS pricing program. As part of this program, we are obligated to make our products available for procurement on an FSS contract under which we must comply with standard government terms and conditions and charge a price that is no higher than the statutory Federal Ceiling Price, or FCP, to four federal agencies (the VA, U.S. Department of Defense, or DOD, Public Health Service, and the U.S. Coast Guard). The FCP is based on the Non-Federal Average Manufacturer Price, or Non-FAMP, which we calculate and report to the VA on a quarterly and annual basis. Pursuant to applicable law, knowing provision of false information in connection with a Non-FAMP filing can subject a manufacturer to significant penalties for each item of false information. These obligations also contain extensive disclosure and certification requirements.

We also participate in the Tricare Retail Pharmacy program, under which we pay quarterly rebates on utilization of innovator products that are dispensed through the Tricare Retail Pharmacy network to Tricare beneficiaries. The rebates are calculated as the difference between the annual Non-FAMP and FCP. We are required to list our covered products on a Tricare Agreement in order for these products to be eligible for DOD formulary inclusion. If we overcharge the government in connection with our FSS contract or Tricare Agreement, whether due to a misstated FCP or otherwise, we are required to refund the difference to the government. Failure to make necessary disclosures and/or to identify contract overcharges can result in allegations against us under the False Claims Act and other laws and regulations. Unexpected refunds to the government, and responding to a government investigation or enforcement

action, would be expensive and time-consuming, and could have a material adverse effect on our business, financial condition, results of operations and growth prospects.

Changes in reimbursement procedures by government and other third-party payors may limit our ability to market and sell our approved drugs. These changes could have a material adverse effect on our business and financial condition.

In the U.S. Europe and ~~abroad,~~other regions globally, sales of pharmaceutical drugs are dependent, in part, on the availability of reimbursement to the consumer from third-party payors, such as government and private insurance plans. Third-party payors are increasingly challenging the prices charged for medical products and services. Some third-party payor benefit packages restrict reimbursement, charge copayments to patients, or do not provide coverage for specific drugs or drug classes.

In addition, certain U.S. based healthcare providers are moving toward a managed care system in which such providers contract to provide comprehensive healthcare services, including prescription drugs, for a fixed cost per person. We are unable to predict the reimbursement policies employed by third-party healthcare payors.

We expect to experience pricing and reimbursement pressures in connection with the sale of our products due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative and executive proposals. In addition, we may confront limitations in insurance coverage for our products. If we fail to successfully secure and maintain reimbursement coverage for our approved drugs or are significantly delayed in doing so, we may have difficulty achieving market acceptance of our approved drugs and investigational drug candidates for which we obtain approval, and our business may be harmed. Congress has enacted healthcare reform and may enact further reform, which could adversely affect the pharmaceutical industry as a whole, and therefore could have a material adverse effect on our business.

Ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations.

Certain provisions of the ACA have been subject to judicial challenges, as well as efforts to repeal or replace them or to alter their interpretation or implementation. ~~Since January 2017,~~Multiple Executive Orders were signed during the Trump administration ~~has signed Executive Orders~~which were designed to delay the implementation of certain provisions of the ACA or otherwise circumvent some of the requirements for health insurance mandated by the ACA. ~~One Executive Order directs federal agencies with authorities and responsibilities under~~For example, the ACA to waive, defer, grant exemptions from, or delay the implementation of any provision of the ACA that would impose a fiscal or regulatory burden on states, individuals, healthcare providers, health insurers, or manufacturers of pharmaceuticals or medical devices. The second Executive Orderprevious administration terminated the cost-sharing subsidies under the ACA. Nineteen state Attorneys General filed suit to stop the administration from terminating the subsidies, but on July 18, 2018, the U.S. District Court for the Northern District of California dismissed the case without prejudice. Further, on June 14, 2018, U.S. Court of Appeals for the Federal Circuit ruled that, due to Congressional appropriations riders that prohibited the ~~Department of Health and Human Services, or~~ HHS from paying out more in risk corridor payments than it collected, HHS was not required to pay more than ~~$12~~$12.0 billion in ACA risk corridor payments owed to insurers under the risk corridor formula. On November 6, 2018, the Federal Circuit declined to rehear the case en ~~banc~~.banc. This decision was appealed to the U.S. Supreme Court, which on April 27, 2020, reversed the U.S. Court of Appeals for the Federal Circuit’s decision and remanded the case to the U.S. Court of Federal Claims, concluding the government has an obligation to pay these risk corridor payments under the relevant formula. It is not clear what effect this result will have on our business, but we will continue to monitor any developments.

Moreover, the Tax Act included a provision that eliminated the tax-based shared responsibility payment for individuals who fail to maintain minimum essential coverage under section 5000A of the Internal Revenue Code of 1986, commonly referred to as the “individual mandate,” effective January 1, 2019. The Bipartisan Budget Act of 2018, or the BBA, among other things, amends the ACA to create a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 70% ~~(increase~~(an increase from 50% effective as of January 1, 2019) point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D.

Under the Trump ~~Administration,~~administration, CMS ~~has~~ issued regulations that ~~give~~gave states greater flexibility, starting in 2020, in the identification of the essential health benefits benchmarks for non-grandfathered individual and small group market health insurance coverage, including plans sold through the health insurance exchanges established under the ACA. On December 14, 2018, the U.S. District Court for the Northern District of Texas ruled (i) that the “individual mandate” was unconstitutional as a result of the associated tax penalty being repealed by Congress as part of the Tax Act; and (ii) the individual mandate is not severable from the rest of the ACA, as a result the entire ACA is invalid. On December 18, 2019, the U.S. Court of Appeals for the Fifth Circuit affirmed the district court’s decision that the individual mandate is unconstitutional, but remanded the case to the district court to reconsider the severability question. On March 2, 2020, the U.S. Supreme Court granted the petitions for writs of certiorari to review this case and held oral arguments on November 10, 2020. It is unclear how the ultimate decision in this case, which is now pending before the U.S. Supreme Court, or other efforts to repeal, replace, or invalidate the ACA or its implementing regulations, or portions thereof, will impact our business. We will continue to evaluate the effect that the ACA and its possible repeal, replacement, or invalidation, in whole or in part, has on our business.

The Trump administration’s budget proposal for fiscal year 2021 included a $135.0 billion allowance to support legislative ~~changes have been proposed~~proposals seeking to reduce drug prices, increase competition, lower out-of-pocket drug costs for patients, and ~~adopted since~~increase patient access to lower-cost generic and biosimilar drugs. On March 10, 2020, the ~~Affordable Care Act was enacted. In August 2011, the Budget Control Act of 2011,~~Trump administration sent “principles” for drug pricing to Congress, calling for legislation that would, among other things, ~~created~~cap Medicare Part D beneficiary out-of-pocket pharmacy expenses, provide an option to cap Medicare Part D beneficiary monthly out-of-pocket expenses, and place limits on pharmaceutical price increases. Further, the ~~Joint Select Committee~~Trump administration also previously released a “Blueprint” to lower drug prices and reduce out of pocket costs of drugs that contains additional proposals to increase manufacturer competition, increase the negotiating power of certain federal healthcare programs, incentivize manufacturers to lower the list price of their products and reduce the out of pocket costs of drug products paid by consumers. The HHS has already started the process of soliciting feedback on ~~Deficit Reduction~~some of these measures and, at the same time, began implementing others under its existing authority. For example, in May 2019, CMS issued a final rule to ~~recommend~~allow Medicare Advantage Plans the option of using step therapy for Part B drugs beginning January 1, 2020. However, it is unclear whether the Biden administration will challenge, reverse, revoke or otherwise modify these executive and administrative actions. In addition, there have been several changes to ~~Congress proposals~~the 340B drug pricing program, which imposes ceilings on prices that drug manufacturers can charge for ~~spending reductions.~~medications sold to certain health care facilities. On December 27, 2018, the District Court for the District of Columbia invalidated a reimbursement formula change under the 340B drug pricing program, and CMS subsequently altered the FYs 2019 and 2018 reimbursement formula on specified covered outpatient drugs, or SCODs. The ~~Joint Select Committee~~court ruled this change was not an “adjustment” which was within the Secretary’s discretion to make but was instead a fundamental change in the reimbursement calculation. However, most recently, on Deficit Reduction did not reach required goals, thereby triggering the legislation’s automatic reductions. This has resulted in aggregate reductions to Medicare payments to providers of, on average, 2% per fiscal year through 2030 unless Congress takes additional action. However, these Medicare sequester reductions will be suspended from May 1, 2020 through DecemberJuly 31, 2020, ~~due to~~ the ~~COVID-19 pandemic.~~

U.S. Court of Appeals for the District of Columbia Circuit overturned the district court’s decision and found that the changes were within the Secretary’s authority. On September 14, 2020, the plaintiffs-appellees filed a Petition for Rehearing En Banc (i.e., before the full court), but was denied on October 16, 2020. It is unclear how these developments could affect covered hospitals who might purchase our future products and affect the rates we may charge such facilities for our approved products in the future, if any. We expect that the healthcare reform measures that have been adopted and may be adopted in the future, may result in more rigorous coverage criteria, and new payment methodologies, and in additional downward pressure on coverage and payment and the price that we receive for any approved product, and could seriously harm our future revenues. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private third-party payors.

There have been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed at broadening the availability of healthcare and containing or lowering the cost of healthcare. The enactment and implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product. Such reforms could have an adverse effect on anticipated revenue from product candidates that we may successfully develop and for which we may obtain regulatory approval and may affect our overall financial condition and ability to develop product candidates.

Failure to comply with health and data protection laws and regulations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation, and/or adverse publicity and could negatively affect our operating results and business.

We and any potential collaborators may be subject to federal, state, and foreign data protection laws and regulations (i.e., laws and regulations that address privacy and data security). In the United States, numerous federal and state laws and regulations, including federal health information privacy laws, state data breach notification laws, state health information privacy laws, and federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), that govern the collection, use, disclosure and protection of health-related and other personal information could apply to our operations or the operations of our collaborators. In addition, we may obtain health information from third parties (including research institutions from which we obtain clinical trial data) that are subject to privacy and security requirements under the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA. Although we are not directly subject to HIPAA – other than with respect to providing certain employee benefits – we could potentially be subject to criminal penalties if we, our affiliates, or our agents knowingly obtain, use, or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA. In addition, state laws govern the privacy and security of health information in specified circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

Compliance with U.S. and international data protection laws and regulations could require us to take on more onerous obligations in our contracts, restrict our ability to collect, use and disclose data, or in some cases, impact our ability to operate in certain jurisdictions. Failure to comply with these laws and regulations could result in government enforcement actions (which could include civil, criminal and administrative penalties), private litigation, and/or adverse publicity and could negatively affect our operating results and business. Moreover, clinical trial subjects, employees and other individuals about whom we or our potential collaborators obtain personal information, as well as the providers who share this information with us, may limit our ability to collect, use and disclose the information. Claims that we have violated individuals’ privacy rights, failed to comply with data protection laws, or breached our contractual obligations, even if we are not found liable, could be expensive and time-consuming to defend and could result in adverse publicity that could harm our business.

European data collection is governed by restrictive regulations governing the use, processing and cross-border transfer of personal information.

The REDUCE-IT cardiovascular outcomes trial was conducted in part through clinical sites in the EU. As a result, we are subject to additional privacy restrictions. The collection and use of personal health data in the EU is governed by the provisions of the General Data Protection Regulation, or GDPR. The GDPR imposes several requirements relating to the legal basis for processing personal data which may include the consent of the individuals to whom the personal data relates, the information provided to the individuals and the security and confidentiality of the personal data. The GDPR also imposes strict rules on the transfer of personal data out of the EU to the United States. Failure to comply with the requirements of the GDPR, and the related national data protection laws of the EU Member States may result in restrictions against regulatory approval in the EU or substantial fines for breaches of the data protection rules. The GDPR may impose additional responsibility and liability in relation to personal data that we process and we may be required to put in place additional mechanisms ensuring compliance with these and/or new data protection rules. This may be onerous and adversely affect our business, financial condition, prospects and results of operations.

* The U.S. FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription products and promotional efforts such as speaker programs. If we or our partners are found to have improperly promoted uses, efficacy or safety of VASCEPA or otherwise are found to have violated the law or applicable regulations, we may become subject to significant fines and other liability. The government may seek to find means to prevent our promotion of truthful and non-misleading information beyond the current court ruling and litigation settlement or seek to find violations of other laws or regulations in connection with the promotional efforts we undertake on our own or through third parties.

The U.S. FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription products. In particular, in general, the U.S. government’s position has been that a product may not be promoted for uses that are not approved by the U.S. FDA as reflected in the product’s approved labeling. The Federal government has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined several companies from engaging in off-label promotion. The U.S. FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. Even though we received U.S. FDA marketing approval for VASCEPA for the MARINE indication and for cardiovascular risk reduction based on the REDUCE-IT study, and we believe the First Amendment court ruling and litigation settlement affords us a degree of protection for other promotional efforts, physicians may still prescribe VASCEPA to their patients for use in the treatment of conditions that are not included as part of the indication statement in our U.S. FDA-approved VASCEPA label or our settlement. If we are found to have promoted VASCEPA outside the terms of the litigation settlement or in violation of what federal or state government may determine to be acceptable, we may become subject to significant government fines and other related liability, such as under the FDCA, the False Claims Act, or other theories of liability. Government may also seek to hold us responsible for the non-compliance of our former co-promotion partner, Kowa, or our commercialization partners outside the United States or other third-parties that we retain to help us implement our business plan.

In addition, incentives exist under applicable laws that encourage competitors, employees and physicians to report violations of rules governing promotional activities for pharmaceutical products. These incentives could lead to so-called “whistleblower lawsuits” as part of which such persons seek to collect a portion of moneys allegedly overbilled to government agencies due to, for example, promotion of pharmaceutical products beyond labeled claims. These incentives could also lead to suits that we have mischaracterized a competitor’s product in the marketplace and we may, as a result, be sued for alleged damages to our competitors. Such lawsuits, whether with or without merit, are typically time-consuming and costly to defend. Such suits may also result in related shareholder lawsuits, which are also costly to defend.

In June 2020, we received a civil investigative demand, or CID, from the U.S. Department of Justice, or the DOJ, informing us that the DOJ is investigating whether aspects of our promotional speaker programs and copayment waiver program during the period from January 1, 2015 to the present violated the U.S. Anti-Kickback Statute and the U.S. False Claims Act in relation to the sale and marketing of VASCEPA by us and our previous co-marketing partner, Kowa Pharmaceuticals America, Inc. Similarly, in March 2021, the FTC issued a CID to us in connection with the FTC’s investigation of whether we have engaged in, or are engaging in, anticompetitive practices or unfair methods of competition relating to VASCEPA. The ~~CID requires~~CIDs require us to ~~produce~~product documents and answer written questions, or interrogatories, relevant to ~~the~~ specified time ~~period.~~periods. We ~~plan to cooperate~~are cooperating with the DOJ and ~~respond to the interrogatories and document requests of the CID.~~FTC, respectively. We cannot predict when ~~the investigation~~these investigations will be resolved, the outcome of the ~~investigation~~investigations or ~~its~~their potential impact on our business. Such investigations can be lengthy, costly and could materially affect and disrupt our business. If the government determines that we have violated the Anti-Kickback Statute and False Claims Act or antitrust regulations, we could be subject to significant civil and criminal fines and penalties.

We may not be successful in developing and receiving regulatory approval for VASCEPA in other jurisdictions or marketing future products if we cannot meet the extensive regulatory requirements of regulatory agencies such as for quality, safety, efficacy and data privacy.

The success of our research and development efforts is dependent in part upon our ability, and the ability of our partners or potential partners, to meet regulatory requirements in the jurisdictions where we or our partners or potential partners ultimately intend to sell such products once approved. The development, manufacture and marketing of pharmaceutical products are subject to extensive regulation by governmental authorities in the United States and elsewhere. In the United States, the U.S. FDA generally requires preclinical testing and clinical trials of each drug to establish its safety and efficacy and extensive pharmaceutical development to ensure its quality before its introduction into the market. Regulatory authorities in other jurisdictions impose similar requirements. The process of obtaining regulatory approvals is lengthy and expensive and the issuance of such approvals is uncertain. The commencement and rate of completion of clinical trials and the timing of obtaining marketing approval from regulatory authorities may be delayed by many factors, including, among others:

Even if we obtain positive results from our efforts to seek regulatory approvals, from early stage preclinical studies or clinical trials, we may not achieve the same success in future efforts. Clinical trials that we or potential partners conduct may not provide sufficient safety and efficacy data to obtain the requisite regulatory approvals for product candidates. The failure of clinical trials to demonstrate safety and efficacy for our desired indications could harm the development of that product candidate as well as other product candidates, and our business and results of operations would suffer. For example, during the public advisory committee meeting held by U.S. FDA as part of its review of our ANCHOR data and sNDA in October 2013, a discussion regarding observed, nominally statistically significant changes from baseline in an adverse direction, while on background statin therapy, in certain lipid parameters, including LDL cholesterol and triglycerides, in the placebo group, raised questions about the possibility that the light liquid paraffin oil, or mineral oil, placebo used in the ANCHOR trial and then in use in the REDUCE-IT trial might not be biologically inert and might be viewed as artificially exaggerating the clinical effect of VASCEPA when measured against placebo. Ultimately, in 2012, ~~no strong evidence for biological activity of mineral oil was identified by~~before the U.S. FDA ~~before its~~ approval of VASCEPA after review of the MARINE and ANCHOR trials and consideration of other data regarding mineral ~~oil.~~oil, no strong evidence for biological activity of mineral oil was identified by the agency. It was ultimately concluded that the between-group differences likely provided the most appropriate descriptions of the treatment effect of VASCEPA and that whatever factor(s) led to the within-group changes over time in the placebo group were likely randomly distributed to all treatment groups. Thus, the U.S. FDA approved VASCEPA for use in the MARINE indication in July 2012, U.S. FDA did not dispute the veracity of the ANCHOR trial data and, in connection with the March 2016 agreement we reached with the U.S. FDA allowing us to promote the results of the ANCHOR study, the U.S. FDA did not seek to require that we include any qualification related to this earlier question regarding the mineral oil placebo.

~~For example,~~ In addition, in connection with U.S. FDA’s review of REDUCE-IT data and sNDA in 2019, the agency determined that an interaction between mineral oil and statins leading to decreased absorption of statins cannot be excluded when the two are co-administered as could have been the case in some patients in REDUCE-IT and that, in the agency’s view, indirect evidence suggested the presence of a potential inhibitory effect on statin absorption by mineral oil. However, U.S. FDA’s exploratory analysis indicated that the effect of LDL cholesterol values on the time to the primary endpoint was numerically small and unlikely to change the overall conclusion of treatment benefit. U.S. FDA then relied on this assessment and all data available to it to approve a new indication statement and labeling based on REDUCE-IT results. This matter illustrates that concerns such as this may arise in the future that could affect our product development, regulatory reviews or the public perception of our products and our future prospects, including REDUCE-IT results.

Any approvals that are obtained may be limited in scope, may require additional post-approval studies or may require the addition of labeling statements, including boxed warnings,

focusing on product safety that could affect the commercial potential for our product candidates. Any of these or similar circumstances could adversely affect our ability to gain approval for new indications and affect revenues from the sale of our products. Even in circumstances where products are approved by a regulatory body for commercialization, the regulatory or legal requirements may change over time, or new safety or efficacy information may be identified concerning a product, which may lead to the withdrawal of a product from the market or similar use restrictions. The discovery of previously unknown problems with a clinical trial or product, or in connection with the manufacturer of products, may result in regulatory issues that prevent proposed future approvals of a product and/or restrictions on that product or manufacturer, including withdrawal of an indication or the product from the market, which would have a negative impact on our potential revenue stream.

As we continue to ~~evolve from a company primarily involved in research and development to a company also focused on establishing an~~build our infrastructure for commercializing VASCEPA, we may encounter difficulties in managing our growth and expanding our operations successfully.

The process of establishing, maintaining and expanding a commercial infrastructure is difficult, expensive and time-consuming. ~~Prior to~~As a result of the ~~REDUCE-IT results topline announcement~~COVID-19 pandemic and the related social distancing, in ~~September 2018,~~March 2020, we suspended face-to-face interactions between our ~~direct sales force consisted of approximately 170 sales professionals, including~~ sales representatives and ~~their managers. Based~~healthcare professionals. We resumed on a limited basis field-based, face-to-face interactions with healthcare providers beginning in June 2020. During the ~~positive REDUCE-IT results, in early 2019, we increased~~late part of the ~~size~~summer of 2020, substantially all of our ~~sales team~~field force personnel were able to ~~approximately 440 sales professionals, including approximately 400 sales representatives~~resume face-to-face customer interactions in a manner consistent with guidelines from local, state and government health officials in the United States. In the fourth quarter of 2020 and in early 2021, the impact of COVID-19 worsened in much of the United States, with some physicians again limiting access to face-to-face interactions with our field force personnel. Accordingly, we have intentionally slowed the hiring of replacements for our open positions which resulted from ordinary turnover. As we witness our sales representatives increasingly able to resume direct interactions with healthcare professionals, we continue to evaluate our needs and it is our intention to fill a ~~result~~significant number of

~~the additional indication and label expansion approved by the FDA in December 2019, in cardiovascular risk reduction, we completed the further expansion of~~ these positions, provided such replacement is appropriate to meet our ~~direct sales force to approximately 900 sales professionals, including approximately 800 sales representatives. This~~business needs. Our sales team promotes VASCEPA to a limited group of physicians and other healthcare professionals in select geographies in the United ~~States. The impact of COVID-19, including the suspension of field based face-to-face interactions for an uncertain period of time may negatively affect promotional efforts. In addition, unless~~States and until its appeal is successful, we intend to reduce the amount spent in the United States on VASCEPA related education and promotion with the intention of retaining the capability to ramp-up promptly if Amarin wins upon appeal. Even after planned expansion, this sales team is not large enough to call upon all physicians.

In addition to sales force expansion in the United States, ~~Amarin continues~~we continue to work on ~~its~~our own and with ~~its~~our international partners to support regulatory efforts outside the United States based on REDUCE-IT results. As our operations expand with the anticipated growth of our product sales, we expect that we will need to manage additional relationships with various collaborative partners, suppliers and other third parties. Future growth will impose significant added responsibilities on members of management, including the need to identify, recruit, maintain and integrate additional employees. For example, in Europe we commenced 2021 with approximately 50 professionals involved in pre-approval and pre-launch planning and other commercial preparation activities, with plans to expand to approximately 300 professionals by the end of 2021. The time required to secure reimbursement tends to vary from country to country and cannot be reliably predicted at this time. While we believe that we have strong arguments regarding the cost effectiveness of VAZKEPA, the success of such reimbursement negotiations could have a significant impact on our ability to hire and retain personnel and realize the commercial opportunity of VAZKEPA in Europe. Our future financial performance and our ability to commercialize VASCEPA and to compete effectively will depend, in part, on our ability to manage our future growth effectively, and such efforts may be disrupted by the COVID-19 protocols. To that end, we must be able to manage our development efforts effectively, and hire, train, integrate and retain additional management, administrative and sales and marketing personnel and have limited experience managing a commercial organization. We may not be able to accomplish these tasks, and our failure to accomplish any of them could prevent us from successfully growing our company.

Our supply of product for the commercial market and clinical trials is dependent upon relationships with third-party manufacturers and suppliers.

We have no in-house manufacturing capacity and rely on contract manufacturers for our clinical and commercial product supply. We cannot ensure that we will successfully manufacture any product we may develop, either independently or under manufacturing arrangements, if any, with our third-party manufacturers. Moreover, if our manufacturers should cease doing business with us or experience delays, shortages of supply or excessive demands on their capacity, we may not be able to obtain adequate quantities of product in a timely manner, or at all. If we are not able to continue to operate our business relationships in a manner that is sufficiently profitable for us and our suppliers, certain members of our supply chain could ~~complete~~compete with us through supply to competitors, such as generic drug companies, through breach of our agreements or otherwise.

Any manufacturing problem, natural or manmade disaster affecting manufacturing facilities, government action, or the loss of a contract manufacturer could be disruptive to our operations and result in lost sales. Any reliance on suppliers may involve several risks, including a potential inability to obtain critical materials and reduced control over production costs, delivery schedules, reliability and quality. Any unanticipated disruption to future contract manufacture caused by problems at suppliers could delay shipment of products, increase our cost of goods sold and/or result in lost sales. If our suppliers were unable to supply us with adequate volumes of active pharmaceutical ingredient (drug substance) or encapsulated bulk product (drug product), it would have a material adverse effect on our ability to continue to commercialize VASCEPA.

We have contractual freedom to source the API for VASCEPA and to procure other services supporting our supply chain. We have entered into supply agreements with multiple suppliers who also rely on other third-party suppliers to manufacture the API and other elements necessary for the sale of VASCEPA. Our strategy in sourcing API and other components in our supply chain from multiple suppliers has been to expand manufacturing capacity, maintain competitive advantages, and mitigate the risk of reliance on any single supplier.

Expanding manufacturing capacity and qualifying such capacity is complex and subject to numerous regulations and other operational challenges. We require supply capacity to support our direct commercialization of VASCEPA in the United States and VAZKEPA in Europe. We are also committed to providing supply to our commercial partners and distributors in Canada, China and MENA. And we anticipate potential additional supply requirements as we pursue commercial opportunities in other countries. The resources of our suppliers vary and are limited; costs associated with projected expansion and qualification can be significant. And, lead-times for supply purchases and capacity expansion are long requiring certain supply related decisions and commitment to be made in advance, for example, prior to commercial launch in China and Europe. There can be no assurance that the expansion plans of any of our suppliers will be successful. Our aggregate capacity to produce API is dependent upon the continued qualification of our API suppliers and, depending on the ability of existing suppliers to meet our supply demands, potentially the qualifications of new suppliers. Each of our API suppliers has outlined plans for potential further capacity ~~expansion.~~expansion, with certain of these expansion plans delayed due to COVID-19 and other market uncertainties. If no additional API supplier is approved by the U.S. FDA as part of an sNDA, our API supply will be limited to the API we purchase from previously approved suppliers. Similarly, the EMA has not initially approved use of each of our suppliers used for VASCEPA in the United States for VAZKEPA in the EU. While we believe that we have sufficient supply of VAZKEPA to support our initial launch plans in Europe, our supply in Europe will be limited until additional suppliers are qualified which qualifications may be delayed by COVID-19 and our exposure to manufacturing issues with our approved suppliers for the EU is less mitigated than is our objective by having more suppliers qualified. If our third-party manufacturing capacity is not expanded and/or compliant with applicable regulatory requirements, we may not be able to supply sufficient quantities of VASCEPA to meet anticipated demand. We cannot guarantee that we can contract with any future manufacturer on acceptable terms or that any such alternative supplier will not require capital investment from us in order for them to meet our requirements. Alternatively, our purchase of supply may exceed actual demand for VASCEPA.

There can be no guarantee that current suppliers and future suppliers with which we have contracted to encapsulate API will be continually qualified to manufacture the product to our specifications or that current and any future suppliers will have the manufacturing capacity to meet anticipated demand for VASCEPA.

We may purchase too much or not enough supply to satisfy actual demand, which could have a material adverse effect on our financial results and financial condition.

Certain of our agreements with our suppliers include minimum purchase obligations and limited exclusivity provisions. These purchases are generally made on the basis of rolling 12-month forecasts which in part are binding on us and the balance of which are subject to adjustment by us subject to certain limitations. Certain of our agreements also include contractual minimum purchase commitments regardless of the rolling 12-month forecasts. We may not purchase sufficient quantities of VASCEPA to meet actual demand or our purchase of supply may exceed actual demand. In either case, such event could have a material adverse effect on our financial results and financial condition.

Our dependence on third parties in the distribution channel from our manufacturers to patients subject us to risks that limit our profitability and could limit our ability to supply VASCEPA to large market segments.

We sell VASCEPA principally to a limited number of major wholesalers, as well as selected regional wholesalers and specialty pharmacy providers, or collectively, our distributors or our customers, that in turn resell VASCEPA to retail pharmacies for subsequent resale to patients and healthcare providers. These parties exercise a substantial amount of bargaining power over us given their control over large segments of the market for VASCEPA. This bargaining power has led us to bear increasingly higher discounts in the sale of VASCEPA. In addition, payors have broad latitude to change individual products’ formulary position or to implement other barriers that inhibit patients from receiving therapies prescribed by their healthcare professionals. These payor barriers include requirements that patients try another drug before VASCEPA, known as step edits, and the requirement that prior authorization be obtained by a healthcare provider after a prescription is written before a patient will be reimbursed by their health plan for the cost of a VASCEPA prescription. Further, pharmacy benefit managers implement plans that act as disincentives for VASCEPA use, such as increasingly higher deductibles. One practical impact of higher deductibles is that they may cause patients to delay filling prescriptions for asymptomatic, chronic care medications such as hypertriglyceridemia earlier in the year, until patients meet their deductible and the cost of VASCEPA is then borne more by their insurance carrier. Collectively, these dynamics negatively affect our profitability for the sale of VASCEPA and could increase over time further impacting our operating results. Consolidation among these industry participants could increase the pressure from these market dynamics.

The manufacture, packaging and distribution of pharmaceutical products such as VASCEPA are subject to U.S. FDA regulations and those of similar foreign regulatory bodies. If we or our third-party manufacturers fail to satisfy these requirements, our product development and commercialization efforts may be materially harmed.

The manufacture, packaging and distribution of pharmaceutical products, such as VASCEPA, are regulated by the U.S. FDA and similar foreign regulatory bodies and must be conducted in accordance with the U.S. FDA’s ~~current good manufacturing practices, or~~ cGMPs and comparable requirements of foreign regulatory bodies. There are a limited number of manufacturers that operate under these cGMPs as well as the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, or ICH, regulations and guidelines, that are both capable of manufacturing VASCEPA and willing to do so. Failure by us or our third-party manufacturers to comply with applicable regulations, requirements, or guidelines could result in sanctions being imposed on us, including fines, injunctions, civil penalties, failure of regulatory authorities to grant marketing approval of our products, delays, suspension or withdrawal of approvals, license revocation, seizures or voluntary recalls of product, operating restrictions and criminal prosecutions and penalties, any of which could significantly and adversely affect our business. If we are not able to manufacture VASCEPA to required specifications through our current and potential API suppliers, we may be delayed in successfully supplying the product to meet anticipated demand and our anticipated future revenues and financial results may be materially adversely affected.

Changes in the manufacturing process or procedure, including a change in the location where the product is manufactured or a change of a third-party manufacturer, may require prior U.S. FDA review and pre-approval of the manufacturing process and procedures in accordance with the U.S. FDA’s cGMPs. Any new facility may be subject to a pre-approval inspection by the U.S. FDA and would again require us to demonstrate product comparability to the U.S. FDA. There are comparable foreign requirements under ICH guidelines. In addition, COVID-19 has limited the ability of suppliers to be inspected. This review may be costly and time consuming and could delay or prevent the launch of a product.

Furthermore, the U.S. FDA and foreign regulatory agencies require that we be able to consistently produce the API and the finished product in commercial quantities and of specified quality on a repeated basis, including demonstrated product stability, and document our ability to do so. This requirement is referred to as process validation. ~~This~~Process validations includes stability testing, measurement of impurities and testing of other product specifications by validated test methods. If the U.S. FDA does not consider the result of the process validation or required testing to be satisfactory, the commercial supply of VASCEPA may be delayed, or we may not be able to supply sufficient quantities of VASCEPA to meet anticipated demand.

The U.S. FDA and similar foreign regulatory bodies may also implement new requirements, or change their interpretation and enforcement of existing requirements, for manufacture, packaging or testing of products at any time. If we or our approved suppliers are unable to comply, we may be subject to regulatory, civil actions or penalties, or we may be prevented from manufacturing or selling VASCEPA, all of which could significantly and adversely affect our business.

* Our commercialization of VASCEPA outside the United States is substantially dependent on third parties and other circumstances outside our control.

We have expanded our VASCEPA commercialization activities outside of the United States through several contractual arrangements in territories including China, the Middle East, North Africa and Canada. We continue to assess other opportunities to develop VASCEPA commercialization outside of the United States through similar arrangements.

In February 2015, we entered into a Development, Commercialization and Supply Agreement, or the DCS Agreement, with Eddingpharm (Asia) Macao Commercial Offshore Limited, or Edding, related to the development and commercialization of VASCEPA in the China Territory. Under the DCS Agreement, ~~Eddingpharm~~Edding is responsible for development and commercialization activities in the China Territory and associated expenses. Additionally, ~~Eddingpharm~~Edding is required to conduct clinical trials in the China Territory to secure regulatory approval in certain territories. For example, in December 2017, ~~Eddingpharm~~Edding commenced a pivotal clinical trial aimed to demonstrate that VASCEPA lowers triglyceride levels and otherwise has beneficial effects in Chinese patients with severe hypertriglyceridemia (TG >~~500~~>500 mg/dL), as we previously demonstrated with VASEPA in the more diverse population studied in the MARINE study. ~~There can be no assurance~~In November 2020, we announced statistically significant positive topline results from Edding’s Phase 3 clinical trial of VASCEPA. On February 9, 2021, we announced that the regulatory review processes for approval of VASCEPA in Mainland China and Hong Kong have commenced. The Chinese National Medical Products Administration, or NMPA, has accepted for review the new drug application for VASCEPA, submitted by Edding, based on the results from the Phase 3 clinical trial and the results from our prior studies of ~~this trial will be~~VASCEPA. We expect to receive a decision from the NMPA in Mainland China near the end of 2021. The Hong Kong Department of Health is evaluating VASCEPA based on current approvals in the United States and Canada. The review process in Hong Kong is expected to conclude near the end of 2021. Even though such results are similar to the ~~results of the~~ MARINE ~~study. Even if such results are similar~~study, additional clinical development efforts may be necessary in this market to demonstrate the effectiveness of VASCEPA in reducing major adverse cardiovascular events in Chinese patients with persistent cardiovascular risk. Any development and regulatory efforts in the China Territory may be negatively impacted by the spread of the coronavirus and the unexpected diversion of resources by regulators and industry professionals to address the coronavirus outbreak. Any development and regulatory efforts in the China Territory may be negatively impacted by heightened political tension between China and the United States, ~~pursuant to~~including in connection with COVID-19 and ~~to overall~~other issues expressed between the countries regarding trade practices, tariffs and honoring intellectual property

rights. If ~~Eddingpharm~~Edding is not able to effectively develop and commercialize VASCEPA in the China Territory, we may not be able to generate revenue from the DCS Agreement resulting from the sale of VASCEPA in the China Territory.

In March 2016, we entered into an agreement with Biologix FZCo, or Biologix, to register and commercialize VASCEPA in several Middle Eastern and North African countries. Under the terms of the distribution agreement, we granted to Biologix a non-exclusive license to use our trademarks in connection with the importation, distribution, promotion, marketing and sale of VASCEPA in the Middle East and North Africa territory. Biologix obtained approval of VASCEPA in Lebanon onin March 2018, in United Arab Emirates onin July 2018, ~~and~~ in Qatar in January 2020 and Bahrain in December 2020. VASCEPA was launched in Lebanon and the United Arab Emirates onin June 2018 and February 2019, respectively. VASCEPA is under registration in additional countries in the MENA region. Commercialization across the Middle East and North Africa is subject to similar risks as in the China Territory, and has been negatively impacted by COVID-19 and the destabilized local economy in Saudi ~~Arabia in the second quarter of 2020.~~Arabia.

In September 2017, we entered into an agreement with HLS Therapeutics Inc., or HLS, to register, commercialize and distribute VASCEPA in Canada. Under the agreement, HLS is responsible for regulatory and commercialization activities and associated costs. ~~Amarin is~~We are responsible for providing assistance towards local filings, supplying finished product under negotiated supply terms, maintaining intellectual property, and continuing the development and funding of REDUCE-IT related activities. In December 2019, VASCEPA was approved for use in Canada to reduce the risk of cardiovascular events in statin-treated patients with elevated triglycerides, who are at high risk of cardiovascular events due to established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor. In January 2020, HLS obtained an extended regulatory exclusivity designation. In February 2020, HLS launched VASCEPA in Canada, with strong initial uptake before the impact of COVID-19 pandemic. In July 2020, Patented Medicine Prices Review Board confirmed VASCEPA price is compliant with current guidelines, and CADTH recommended reimbursement for VASCEPA in Canada in secondary prevention population. However, if HLS ~~Therapeutics~~ is not able to effectively commercialize VASCEPA in Canada through effective pricing (initially and over time), reimbursement or otherwise we may not be able to generate revenue from the sale of VASCEPA in Canada.

Our efforts to launch ~~VASCEPA~~VAZKEPA on our own in Europe ~~assuming a regulatory approval,~~ is a complex undertaking for a company that has not launched a product in Europe and could be subject to significant risks of execution to our successful development of ~~VASCEPA~~VAZKEPA in Europe. While various of our suppliers have been inspected and we do not anticipate supply availability limiting our launch in Europe, COVID-19 has limited the ability of suppliers to be inspected and not all of our suppliers have completed all of the requirements of the European regulatory authorities.

We have limited experience working with partners outside the United States to develop and market our products in non-U.S. jurisdictions. In order for our partners to market and sell VASCEPA in any country outside of the United States for any indication, it will be necessary to obtain regulatory approval from the appropriate regulatory authorities. The requirements and timing for regulatory approval, which may include conducting clinical trials, vary widely from country to country and may in some cases be different than or more rigorous than requirements in the United States. Any failure by us or our partners to obtain approval for VASCEPA in non-U.S. jurisdictions in a timely manner may limit the commercial success of VASCEPA and our ability to grow our revenues.

* Our relationships with healthcare providers and physicians and third-party payors are subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose use to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

Healthcare providers, physicians and third-party payors in the United States and elsewhere play a primary role in the recommendation and prescription of pharmaceutical products. Arrangements with third-party payors and customers can expose pharmaceutical manufacturers to broadly applicable fraud and abuse and other healthcare laws and regulations, which may constrain the business or financial arrangements and relationships through which such companies sell, market and distribute pharmaceutical products. In particular, the promotion, sales and marketing of healthcare items and services, as well as a wide range of pricing, discounting, marketing and promotion, structuring and commission(s), certain customer incentive programs and other business arrangements, are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices. The applicable federal and state healthcare laws and regulations laws that may affect our ability to operate include, but are not limited to:

The distribution of pharmaceutical products is subject to additional requirements and regulations, including extensive record-keeping, licensing, storage and security requirements intended to prevent the unauthorized sale of pharmaceutical products.

The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially in light of the lack of applicable precedent and regulations. Federal and state enforcement bodies continue to give regular and close scrutiny to interactions between healthcare companies and healthcare providers, and such scrutiny

often leads to investigations, prosecutions, convictions and settlements in the healthcare industry. Ensuring business arrangements comply with applicable healthcare laws, as well as responding to possible investigations by government authorities, can be time- and resource-consuming and can divert a company’s attention from the business. For example, in June 2020, we received a ~~civil investigative demand, or~~ CID from ~~the U.S. Department of Justice, or~~ the DOJ informing us that the DOJ is investigating ~~allegations that false claims were submitted~~whether aspects of our promotional speaker programs and copayment waiver program during the period from January 1, 2015 to ~~federal healthcare programs in violation of~~the present violated the U.S. Anti-Kickback Statute and the U.S. False Claims Act in relation to the sale and marketing of VASCEPA ~~as marketed~~ by us and our previous co-marketing partner, Kowa Pharmaceuticals, Inc. ~~and~~Similarly, in March 2021, the FTC issued a CID to us in connection with ~~speaker programs~~the FTC’s investigation of whether we have engaged in, or is engaging in, anticompetitive practices or unfair methods of competition relating to VASCEPA. The CIDs require us to produce documents and ~~copayment waivers. The investigation also covers information that would be~~answer written questions, or interrogatories, relevant to ~~determining whether violations of~~specified time periods. We [produced the ~~U.S. Anti-Kickback Statute occurred. The CID requires the production of documents and~~requested information ~~from January 1, 2015 to the present. We~~and] are ~~in the process of responding to the DOJ with the required documents and information, including answers to written interrogatories. We plan to cooperate~~cooperating with the DOJ ~~on this investigation, we~~and FTC, respectively. We cannot predict when ~~the investigation~~these investigations will be resolved, the outcome of the ~~investigation~~investigations or ~~its~~their potential impact on our business. Such investigations can be lengthy, costly and could materially affect and disrupt our business. If the government determines that we have violated the Anti-Kickback Statute and ~~Fake~~False Claims Act or antitrust regulations, we could be subject to significant civil and criminal fines and penalties.

The failure to comply with any of these laws or regulatory requirements subjects entities to possible legal or regulatory action. Depending on the circumstances, failure to meet applicable regulatory requirements can result in significant civil, criminal and administrative penalties, damages, fines, disgorgement, individual imprisonment, exclusion from participation in federal and state funded healthcare programs (such as Medicare and Medicaid), contractual damages and the curtailment or restructuring of our operations, as well as additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws. Any action for violation of these laws, even if successfully defended, could cause a pharmaceutical manufacturer to incur significant legal expenses and divert management’s attention from the operation of the business. If any of the physicians or other healthcare providers or entities with whom we expect to do business is

found not to be in compliance with applicable laws, that person or entity may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs. Prohibitions or restrictions on sales or withdrawal of future marketed products could materially affect business in an adverse way.

Although compliance programs can mitigate the risk of investigation and prosecution for violations of these laws, it is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent inappropriate conduct may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations.

In addition, with the approval and commercialization of any of our products outside the United States, we will also likely be subject us to foreign equivalents of the healthcare laws mentioned above, among other foreign laws.

We rely on third parties to conduct our clinical trials, and those third parties may not perform satisfactorily, including failing to meet established deadlines for the completion of such clinical trials.

Our reliance on third parties for clinical development activities reduces our control over these activities. However, if we sponsor clinical trials, we are responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trials. Moreover, the U.S. FDA requires us to comply with requirements, commonly referred to as good clinical practices, for conducting, recording, and reporting the results of clinical trials to ensure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. Our reliance on third parties does not relieve us of these responsibilities and requirements. Furthermore, these third parties may also have relationships with other entities, some of which may be our competitors. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may be delayed in obtaining regulatory approvals for our product candidates and may be delayed in our efforts to successfully commercialize our product candidates for targeted diseases.

* We are dependent on patents, proprietary rights and confidentiality to protect the commercial potential of VASCEPA.

Our success depends in part on our ability to obtain and maintain intellectual property protection for our drug candidates, technology and know-how, and to operate without infringing the proprietary rights of others. While certain key patents related to our product based on the MARINE clinical study were determined to be invalid as obvious by a district court in the United States, and we are pursuing an appeal ~~of that judgment,~~process, it remains the case that our ability to successfully implement our business plan and to protect our products with our intellectual property will depend in large part on our ability to:

We have prosecuted, and are currently prosecuting, multiple patent applications to protect the intellectual property developed during the VASCEPA development program. As of the date of this report, we had 96112 patent applications in the United States that have been either issued or allowed and more than 30 additional patent applications are pending in the United States. Such 96112 allowed and issued applications include the following:

A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application. A Notice of Allowance does not afford patent protection until the underlying patent is issued by the USPTO. No assurance can be given that applications with issued notices of allowance will be issued as patents or that any of our pending patent applications will issue as patents. No assurance can be given that, if and when issued, our patents will prevent competitors from competing with VASCEPA. For example, we may choose to not assert all issued patents in patent litigation and patents or claims within patents may be determined to be invalid.

We are the owner of the above-listed patents. We are also the exclusive licensee of certain patents owned by others covering products and products in development. ~~To secure our debt under our outstanding royalty-like instrument, we have granted the holders of such instrument a security interest in our VASCEPA-related patents.~~

We are also pursuing patent applications related to VASCEPA in multiple jurisdictions outside the United States. Geographies outside the United States in which VASCEPA is sold and under regulatory review are not subject to the U.S. patent litigation and judgment. No litigation involving potential generic versions of VASCEPA is pending outside the United States. VASCEPA is currently available by prescription in Canada, Lebanon and the United Arab Emirates. In Canada, VASCEPA has the benefit of ~~eight years of~~ data protection afforded through Health Canada (until the end of 2027), in addition to separate patent protection with expiration dates that could extend into 2039. ~~Amarin is~~We are pursuing additional regulatory approvals for VASCEPA in Europe, China and the Middle East. In China and the Middle East, ~~Amarin is~~we are pursuing such regulatory approvals and subsequent commercialization of VASCEPA with commercial partners. ~~Ten to eleven~~The European Commission, or EC, approval provides ten years of market protection ~~is anticipated due to regulatory exclusivity~~ in the European Union subject to an approval recommendation by the European Medicines Agency, or EMA, anticipated near the end of 2020 and associated European Community, or EC, approval expected promptly thereafter. In additionEU. Furthermore, patent protection in Europe ~~includes~~includes:

One allowed patent related to the ~~following:~~use of a pharmaceutical composition comprised of 4g of 96% EPA ethyl ester to treat the REDUCE-IT population expiring 2033.

In addition, pending patent applications in Europe have the potential to extend exclusivity into 2039.

We may be dependent in some cases upon third-party licensors to pursue filing, prosecution and maintenance of patent rights or applications owned or controlled by those parties, including, for example, under our collaboration with Mochida. It is possible that

third parties will obtain patents or other proprietary rights that might be necessary or useful to us. In cases where third parties are first to invent a particular product or technology, or first to file after various provisions of the America Invents Act of 2011 went into effect on March 16, 2013, it is possible that those parties will obtain patents that will be sufficiently broad so as to prevent us from utilizing such technology or commercializing our current and future products.

Although we intend to make reasonable efforts to protect our current and future intellectual property rights and to ensure that any proprietary technology we acquire or develop does not infringe the rights of other parties, we may not be able to ascertain the existence of all potentially conflicting claims. Therefore, there is a risk that third parties may make claims of infringement against our current or future products or technologies. In addition, third parties may be able to obtain patents that prevent the sale of our current or future products or require us to obtain a license and pay significant fees or royalties in order to continue selling such products.

We may in the future discover the existence of products that infringe patents that we own or that have been licensed to us. If we were to initiate legal proceedings against a third party to stop such an infringement, such proceedings could be costly and time consuming, regardless of the outcome. No assurances can be given that we would prevail, and it is possible that, during such a proceeding, our patent rights could be held to be invalid, unenforceable or both. Although we intend to protect our trade secrets and proprietary know-how through confidentiality agreements with our manufacturers, employees and consultants, we may not be able to prevent parties subject to such confidentiality agreements from breaching these agreements or third parties from independently developing or learning of our trade secrets.

We anticipate that competitors may from time to time oppose our efforts to obtain patent protection for new technologies or to submit patented technologies for regulatory approvals. Competitors may seek to oppose our patent applications to delay the approval process or to challenge our granted patents, for example, by requesting a reexamination of our patent at the USPTO, or by filing an opposition in a foreign patent office, even if the opposition or challenge has little or no merit. For example, one of our patents was revoked in an opposition proceeding in Europe due to a determination of improper claim amendments under a provision of law not applicable in the United States. Such proceedings are generally highly technical, expensive, and time consuming, and there can be no assurance that such a challenge would not result in the narrowing or complete revocation of any patent of ours that was so challenged.

Our issued patents may not prevent competitors from competing with VASCEPA, even if we seek to enforce our patent rights.

We plan to vigorously defend our rights under issued patents. For example, ~~in March 2014,~~on November 30, 2020 we filed a patent infringement ~~suit~~lawsuit against ~~Omthera Pharmaceuticals, Inc.,~~Hikma for making, selling, offering to sell and ~~its parent company, AstraZeneca Pharmaceuticals LP. The suit sought injunctive relief~~importing generic icosapent ethyl capsules in and ~~monetary damages for~~into the United States in a manner that we allege has induced the infringement of ~~our U.S. Patent No. 8,663,662. The complaint alleged~~patents covering the use of VASCEPA to reduce specified cardiovascular risk. On January 25, 2021, we expanded the scope of this patent infringement ~~of the patent arising from the then expected launch of Epanova,~~lawsuit to include a product that, in 2014, was expected to compete with VASCEPA in the United States. In November 2014, based on a representation from AstraZeneca Pharmaceuticals LP in the court proceedings that the commercial launch of Epanova was not imminent, the court dismissed our complaint, without prejudice (i.e., preserving our ability to later re-file the suit). The court required the defendant to notify us before any product launch. While we no longer expect a launch of Epanova due to the clinical failure of the STRENGTH cardiovascular outcomes trial announced in January 2020, wehealth care insurance provider, Health Net, LLC. We intend to vigorously pursue ~~this~~these ongoing litigation ~~vigorously and aggressively protect~~matters, but cannot predict the outcomes or the impact on our ~~intellectual property rights should the product be launched.~~business. We likewise plan to engage in similar patent litigation should other competitors arise with products that infringe our intellectual property rights.

Patent litigation is a time-consuming and costly process. There can be no assurance that we will be successful in enforcing this patent or that it will not be successfully challenged and invalidated. Even if we are successful in enforcing this patent, the process could take years to reach conclusion.

Other drug companies may challenge the validity, enforceability, or both of our patents and seek to design its products around our issued patent claims and gain marketing approval for generic versions of VASCEPA or branded competitive products based on new clinical studies. The pharmaceutical industry is highly competitive and many of our competitors have greater experience and resources than we have. Any such competition could undermine sales, marketing and collaboration efforts for VASCEPA, and thus reduce, perhaps materially, the revenue potential for VASCEPA.

Even if we are successful in enforcing our issued patents, we may incur substantial costs and divert management’s time and attention in pursuing these proceedings, which could have a material adverse effect on us. Patent litigation is costly and time consuming, and we may not have sufficient resources to bring these actions to a successful conclusion.

There can be no assurance that any of our pending patent applications relating to VASCEPA or its use will issue as patents.

We have filed and are prosecuting numerous families of patent applications in the United States and internationally with claims designed to protect the proprietary position of VASCEPA. For certain of these patent families, we have filed multiple patent applications. Collectively the patent applications include numerous independent claims and dependent claims. Several of our patent applications contain claims that are based upon what we believe are unexpected and favorable findings from ~~the MARINE, ANCHOR and REDUCE-IT~~our clinical trials. If granted, many of the resulting granted patents from REDUCE-IT, for example, would expire in 2039, beyond the 2030 ~~or beyond.~~and 2033 expiration dates of currently issued REDUCE-IT patents. However, no assurance can be given that ~~these additional patents or~~ any of our pending patent applications ~~intended to cover the indication based on results from the REDUCE-IT clinical trial~~ will be granted or, if they grant, that they will prevent competitors from competing with VASCEPA.

Securing patent protection for a product is a complex process involving many legal and factual questions. The patent applications we have filed in the United States and internationally are at varying stages of examination, the timing of which is outside our control. The process to getting a patent granted can be lengthy and claims initially submitted are often modified in order to satisfy the requirements of the patent office. This process includes written and public communication with the patent office. The process can

also include direct discussions with the patent examiner. There can be no assurance that the patent office will accept our arguments with respect to any patent application or with respect to any claim therein. ~~The timing of the patent review process is independent of and has no effect on the timing of the FDA’s review of our NDA or sNDA submissions.~~ We cannot predict the timing or results of any

patent application. In addition, we may elect to submit, or the patent office may require, additional evidence to support certain of the claims we are pursuing. Furthermore, third parties may attempt to submit publications for consideration by the patent office during examination of our patent applications. Providing such additional evidence and publications could prolong the patent office’s review of our applications and result in us incurring additional costs. We cannot be certain what commercial value any granted patent in our patent estate will provide to us.

Despite the use of confidentiality agreements and/or proprietary rights agreements, which themselves may be of limited effectiveness, it may be difficult for us to protect our trade secrets.

In addition to our patent portfolio and strategy, we will also rely upon trade secrets and know-how to help protect our competitive position. We rely on trade secrets to protect technology in cases when we believe patent protection is not appropriate or obtainable. However, trade secrets are difficult to protect. While we require certain of our academic collaborators, contractors and consultants to enter into confidentiality agreements, we may not be able to adequately protect our trade secrets or other proprietary information.

If the estimates we make, or the assumptions on which we rely, in preparing our projected guidance prove inaccurate, our actual results may vary from those reflected in our projections and accruals.

In January ~~2020,~~2021, we issued financial and business guidance, including ~~expected fiscal year 2020 total net revenue and~~ expectations regarding inventory build, and ~~2020~~2021 operating expenses. ~~We have since updated certain aspects of that guidance.~~ All such guidance and updates are based on estimates, assumptions and the judgment of management. Because of the inherent nature of estimates, including during the uncertainty of COVID-19’s impact on our business, we have suspended providing net revenue guidance and there could be significant differences between our estimates and the actual amount of product demand. If we fail to realize or if we change or update any element of our publicly disclosed financial guidance as we have done in the past or other expectations about our business change, our stock price could decline in value.

~~Potential technological~~* The loss of key personnel could have an adverse effect on our business, particularly in light of our recent announcement of management succession plan.

We are highly dependent upon the efforts of our senior management. The loss of the services of one or more members of senior management could have a material adverse effect on us. Given our rapidly expanding enterprise coupled with a streamlined management structure, the departure of any key person could have a significant impact and would be potentially disruptive to our business until such time as a suitable replacement is hired. In April 2021, we announced that John Thero, President and Chief Executive Officer, will retire from his positions as President and Chief Executive Officer and member of the Board of Directors effective August 1, 2021 and will provide phased transitional and consulting services to us thereafter. The Board of Directors has appointed Karim Mikhail, currently our Senior Vice President, Commercial Head Europe, to succeed Mr. Thero as our next President and Chief Executive Officer, as well as, a member of the Board of Directors, effective August 1, 2021. In April 2021, we also announced that Joseph Kennedy will retire from his position as Executive Vice President, General Counsel effective August 1, 2021 (or such later date as may be decided between Mr. Kennedy and the Board of Directors). A search has commenced to hire a new General Counsel, with Mr. Kennedy also intending to support this transition and to provide consulting support on certain legal matters. Although we anticipate smooth transitions, any such changes to senior management, can be disruptive to operations, including by distracting management from our core business and effective employee productivity. Furthermore, because of the specialized nature of our business, as our business plan progresses, we will be highly dependent upon our ability to attract and retain qualified scientific, technical and key management personnel. As we continue to expand our commercialization efforts, particularly on a global scale, we may experience increased turnover among members of our senior management team. We may have difficulty identifying, attracting and integrating new executives to replace any such losses. As we prepare for commercialization in Europe, we need to rapidly hire employees and ensure that they are well trained and working cohesively with core values which are consistent with our ~~field of business create considerable uncertainty.~~

~~The pharmaceutical industry in~~existing operations and which, we ~~operate~~believe, help improve our position for success. In the United States, employees are increasingly being recruited by other companies. While our business priorities emphasize continued promotion of VASCEPA in the United States, the current and potential threat of generic competition can create employee uncertainty which could lead to increased employee turnover. There is ~~characterized by extensive research efforts and rapid technological progress. New developments~~intense competition for qualified personnel in ~~research are expected to continue at a rapid pace in both industry and academia. We cannot assure you that research and discoveries by others will not render some or all~~the areas of our ~~programs or product candidates uncompetitive or obsolete. Our business strategy is based in part upon new~~activities. In this environment, we may not be able to attract and ~~unproven technologies to~~retain the personnel necessary for the development of ~~therapeutics~~our business, particularly if we do not achieve profitability. The failure to ~~improve cardiovascular health. We cannot assure you that unforeseen problems will not develop with these technologies or applications or that any commercially feasible products will ultimately~~recruit key scientific, technical and management personnel would be ~~developed by us.~~detrimental to our ability to implement our business plan.

Our internal computer systems, or those of our third‑party clinical research organizations or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our research and development programs.

Despite the implementation of security measures, our internal computer systems and those of our ~~third-party~~third‑party clinical research organizations and other contractors and consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war, and telecommunication and electrical failures. Any such incident could cause interruptions in our operations or a material disruption of our programs. To the extent that any disruption or security breach results in a loss of or damage to our data or applications or other data or applications relating to our technology or products candidates, or inappropriate disclosure of confidential or proprietary information, we could incur liabilities and our research and development program could be delayed.

We could be subject to risks caused by misappropriation, misuse, leakage, falsification or intentional or accidental release or loss of information maintained in the information systems and networks of our company and our vendors, including personal information of our employees and patients, and company and vendor confidential data. In addition, outside parties may attempt to penetrate our systems or those of our vendors or fraudulently induce our personnel or the personnel of our vendors to disclose sensitive information in order to gain access to our data and/or systems. We may experience threats to our data and systems, including malicious codes and viruses, phishing and other cyber-attacks. The number and complexity of these threats continue to increase over time. For example, in June 2019, a report published by security researchers claimed that a database belonging to one of our vendors containing information about individuals who use or have expressed interest in VASCEPA was accessible to unauthorized users. Although we were informed that such breach did not include social security numbers or credit card information, we cannot guarantee that a more material breach will not occur in the future. If a material breach of our information technology systems or those of our vendors occurs, the market perception of the effectiveness of our security measures could be harmed and our reputation and credibility could be damaged. We could be required to expend significant amounts of money and other resources to repair or replace information systems or networks and to repair reputational costs. In addition, we could be subject to regulatory actions and/or claims made by individuals and groups in private litigation involving privacy issues related to data collection and use practices and other data privacy laws and regulations, including claims for misuse or inappropriate disclosure of data, as well as unfair or deceptive practices. We may

incur significant costs or divert significant internal resources as a result of any regulatory actions or private litigation. Any of the foregoing consequences may adversely affect our business and financial condition.

Although we develop and maintain systems and controls designed to prevent these events from occurring, and we have a process to identify and mitigate threats, the development and maintenance of these systems, controls and processes is costly and requires ongoing monitoring and updating as technologies change and efforts to overcome security measures become increasingly sophisticated. Moreover, despite our efforts, the possibility of these events occurring cannot be eliminated entirely. As we outsource more of our information systems to vendors, engage in more electronic transactions with payors and patients, and rely more on cloud-based information systems, the related security risks will increase and we will need to expend additional resources to protect our technology and information systems. In addition, there can be no assurance that our internal information technology systems or those of our third-party contractors, or our consultants’ efforts to implement adequate security and control measures, will be sufficient to protect us against breakdowns, service disruption, data deterioration or loss in the event of a system malfunction, or prevent data from being stolen or corrupted in the event of a cyberattack, security breach, industrial espionage attacks or insider threat attacks which could result in financial, legal, business or reputational harm.

We are subject to the potential risk of product liability claims relating to the manufacturing and marketing of VASCEPA. Any person who is injured as a result of using VASCEPA may have a product liability claim against us without having to prove that we were at fault.

In addition, we could be subject to product liability claims by persons who took part in clinical trials involving our current or former development stage products. A successful claim brought against us could have a material adverse effect on our business. We cannot guarantee that a product liability claim will not be asserted against us in the future.

A change in our tax residence could have a negative effect on our future profitability.

We expect that our tax jurisdiction will remain in Ireland. Under current UK legislation, a company incorporated in England and Wales, or which is centrally managed and controlled in the UK, is regarded as resident in the UK for taxation purposes. Under current Irish legislation, a company is regarded as resident for tax purposes in Ireland if it is centrally managed and controlled in Ireland, or, in certain circumstances, if it is incorporated in Ireland. Up to December 31, 2019, where a company was treated as tax resident under the domestic laws of both the UK and Ireland, then the provisions of article 4(3) of the Double Tax Agreement, or DTA, between the UK and Ireland provided that such enterprise would be treated as resident only in the jurisdiction in which its place of effective management is situated. We had at all times sought to conduct our affairs in such a way so as to be solely resident in Ireland for tax purposes by virtue of having our place of effective management situated in Ireland.

These rules regarding determination of tax residence changed effective January 1, 2020, when a modified Ireland-UK DTA came into effect pursuant to the OECD’s Multilateral Instrument, or MLI. Under the modified Ireland-UK DTA, from January 1, 2020, we would be solely tax resident in Ireland and not tax resident in the UK if we continued to be centrally managed and controlled in Ireland and if it were mutually agreed between the Irish and UK tax authorities under the MLI “tie-breaker rule” that we are solely tax resident in Ireland. Having made the relevant submission under the amended provisions, we received confirmation effective January 1, 2020 of the mutual agreement of Irish and UK tax authorities that we are solely tax resident in Ireland for the purposes of the modified DTA.

However, we cannot assure you that we are or will continue to be solely resident in Ireland for tax purposes. It is possible that in the future, whether as a result of a change in law or the practice of any relevant tax authority or as a result of any change in the conduct of our affairs, we could become, or be regarded as having become resident in a jurisdiction other than Ireland. Should we cease to be an Irish tax resident, we may be subject to a charge to Irish capital gains tax on our assets and the basis on which our income is taxed may also change. Similarly, if the tax residency of our Irish or UK subsidiaries were to change from their current jurisdiction, they may be subject to a charge to local capital gains tax on their assets and the basis on which their income is taxed may also change.

Our and our subsidiaries’ income tax returns are periodically examined by various tax authorities, including the Internal Revenue Service, or the IRS, and states. ~~We recently completed the audits by the IRS for the years 2013 to 2014, with no material changes to the filed income tax returns. In addition,~~For example, the IRS began an examination of our 2018 US income tax return in the first quarter of 2020. Although the outcome of tax audits is always uncertain and could result in significant cash tax payments, we do not believe the outcome of any ongoing or future audits will have a material adverse effect on our consolidated financial position or results of operations.

~~The effect on us of comprehensive U.S. tax reform legislation whether adverse or favorable, is uncertain.~~

On December 22, 2017, President Trump signed into law H.R. 1, “An Act to provide for reconciliation pursuant to titles II and V of the concurrent resolution on the budget for fiscal year 2018”, or informally, the Tax Cuts and Jobs Act. Among a number of significant changes to the U.S. federal income tax rules, the Tax Cuts and Jobs Act reduces the marginal U.S. corporate income tax rate from 35% to 21%, limits the deduction for net interest expense, shifts the United States toward a more territorial tax system, and imposes new taxes to combat erosion of the U.S. federal income tax base. The effect of the Tax Cuts and Jobs Act on our company and our affiliates, whether adverse or favorable, is uncertain, and may not become evident for some period of time. You are urged to consult your tax adviser regarding the implications of the Tax Cuts and Jobs Act for an investment in our ADSs.

A significant portion of our sales are to wholesalers in the pharmaceutical industry. Three customers individually accounted for 10% or more of our gross product sales. Customers A, B, and C accounted for ~~25%~~27%, ~~37%~~35%, and ~~29%~~31%, respectively, of gross product sales for the ~~six~~three months ended ~~June 30, 2020,~~March 31, 2021, and represented ~~32%~~35%, ~~38%~~36%, and ~~23%~~24%, respectively, of the gross accounts receivable balance as of ~~June 30, 2020.~~March 31, 2021. Customers A, B, and C accounted for 24%, ~~37%~~35%, and ~~29%~~32%, respectively, of gross product sales for the ~~six~~three months ended ~~June 30, 2019,~~March 31, 2020, and represented ~~38%~~32%, ~~32%~~27%, and ~~22%~~30%, respectively, of the gross accounts receivable balance as of ~~June 30, 2019.~~March 31, 2020. There can be no guarantee that we will be able to sustain our accounts receivable or gross sales levels from our key customers. If, for any reason, we were to lose, or experience a decrease in the amount of business with our largest customers, whether directly or through our distributor relationships, our financial condition and results of operations could be negatively affected.

* Legal, political and economic uncertainty surrounding the exit of the UK from the EU may be a source of instability in international markets, create significant currency fluctuations, adversely affect our operations in the UK and pose additional risks to our business, revenue, financial condition, and results of operations.

On June 23, 2016, the UK held a referendum in which a majority of the eligible members of the electorate voted to leave the EU, commonly referred to as Brexit. Pursuant to Article 50 of the Lisbon Treaty, the UK ceased being a Member State of the EU on January 31, 2020. However, the terms of the withdrawal have yet to be fully negotiated and the UK is currently in an implementation period which began on January 31, 2020 and will continue until December 31, 2020. During this 11-month period, the UK remains subject to the majority of the EU’s rules, including the EU’s pharmaceutical law, and the UK’s trading relationship will remain the same. A trade deal is currently being negotiated between the UK and the EU but it is unclear whether an agreement on the terms of future trade will be reached by December 31, 2020 and, even if a deal is reached, what such a deal will look like. In addition, the UK is negotiating deals in a number of other areas where cooperation with the EU is required, and there is uncertainty as to which EU regulations and directives will be replicated into UK domestic law, or replaced, going forward. This lack of clarity on future UK laws and regulations and their divergence from, or consistency with, the EU laws and regulations may negatively impact foreign direct investment in the UK, increase costs, depress economic activity and restrict access to capital.

The continued uncertainty concerning the UK’s legal, political and economic relationship with the EU after Brexit may be a source of instability in the international markets, create significant currency fluctuations, and/or otherwise adversely affect trading agreements or similar cross-border co-operation arrangements (whether economic, tax, fiscal, legal, regulatory or otherwise) both during and (depending on the terms of any trade deal that is reached) after the implementation period.

These developments, or the perception that any of them could occur, may have a significant adverse effect on global economic conditions and the stability of global financial markets, and could significantly reduce global market liquidity and limit the ability of key market participants to operate in certain financial markets. In particular, it could also lead to a period of considerable uncertainty in relation to the UK financial and banking markets, as well as on the regulatory process in Europe. Asset valuations, currency exchange rates and credit ratings may also be subject to increased market volatility.

If the UK and the EU are unable to negotiate acceptable agreements or if other EU member states pursue withdrawal, barrier-free access between the UK and other EU member states or among the European Economic Area, or EEA, overall could be diminished or eliminated. The long-term effects of Brexit will depend on any agreements (or lack thereof) between the UK and the EU and, in particular, any arrangements for the UK to retain access to EU markets either during the transitional period or more permanently.

Such a withdrawal from the EU is unprecedented, and it is unclear how the UK’s access to the European single market for goods, capital, services and labor within the EU, or single market, and the wider commercial, legal and regulatory environment, will impact our current and future operations (including business activities conducted by third parties and contract manufacturers on our behalf) and clinical activities in the UK. In addition to the foregoing, our UK operations support our current and future operations and clinical activities in other countries in the EU and EEA and these operations and clinical activities could be disrupted by the ongoing effects of Brexit, particularly in regards to the specific terms of any trade deal that is reached between the UK and the EU.

We may also face new regulatory costs and challenges that could have an adverse effect on our operations. Depending on the terms of any trade deal between the UK and EU, the UK could lose the benefits of global trade agreements negotiated by the EU on behalf of its members, which may result in increased trade barriers that could make our doing business in the EU and the EEA more difficult. Since the regulatory framework in the UK covering quality, safety and efficacy of pharmaceutical products, clinical trials, marketing authorization, commercial sales and distribution of pharmaceutical products is derived from EU directives and regulations, Brexit could materially impact the future regulatory regime with respect to the approval of our product candidates in the UK. For instance, in November 2017, EU member states voted to move the EMA, the EU’s regulatory body for medicines, from London to Amsterdam. Operations in Amsterdam commenced in March 2019, and the move itself may cause significant disruption to the regulatory approval process in Europe. It remains to be seen how, if at all, Brexit will impact regulatory requirements for product candidates and products in the UK, particularly after the end of the implementation period. Any delay in obtaining, or an inability to obtain, any regulatory approvals, as a result of Brexit or otherwise, would prevent us from commercializing our product candidates in the UK and/or the EU and restrict our ability to generate revenue and achieve and sustain profitability. If any of these outcomes occur, we may be forced to restrict or delay efforts to seek regulatory approval in the UK and/or EU for our product candidates, which could significantly and materially harm our business. The uncertainty around the UK’s future relationship with the EU continues to cause economic uncertainty which could adversely impact customer confidence resulting in customers reducing their spending budgets on our solutions, which could adversely affect our business, revenue, financial condition, results of operations and could adversely affect the market price of our ADSs.

We have a history of operating losses and anticipate that we will incur continued losses for an indefinite period of time.

We have not yet reached sustained profitability. For the fiscal years ended December 31, 2020, 2019, ~~2018,~~ and ~~2017,~~2018, we reported losses of approximately $18.0 million, $22.6 million, and $116.4 million, and ~~$67.9~~we had an accumulated deficit as of December 31, 2020 of $1.4 billion. For the three months ended March 31, 2021 and 2020, we reported losses of approximately $1.6 million and $20.6 million, respectively, and we had an accumulated deficit as of ~~December~~March 31, 2019 of $1.4 billion. For the six months ended June 30, 2020 and 2019, we reported losses of approximately $16.1 million and $26.3 million, respectively, and we had an accumulated deficit as of June 30, 20202021 of $1.4 billion. Substantially all of our operating losses resulted from costs incurred in connection with our research and development programs, from general and administrative costs associated with our operations, and costs related to the commercialization of VASCEPA. Additionally, as a result of our significant expenses relating to research and development and to commercialization, we expect to continue to incur significant operating losses for an indefinite period. Because of the numerous risks and uncertainties associated with developing and commercializing pharmaceutical products, we are unable to predict the magnitude of these future losses. Our historic losses, combined with expected future losses, have had and will continue to have an adverse effect on our cash resources, shareholders’ deficit and working capital.

Although we began generating revenue from VASCEPA in January 2013, we may never be profitable for a full year.

Our ability to become profitable on a sustained basis depends upon our ability to generate revenue. We have been generating product revenue from sales of VASCEPA since January 2013, but we may not be able to generate sufficient revenue to achieve a steady state of profitability. Our ability to generate profits on sales of VASCEPA is subject to the market acceptance and commercial success of VASCEPA and our ability to manufacture commercial quantities of VASCEPA through third parties at acceptable cost levels, and may also depend upon our ability to effectively market and sell VASCEPA through our strategic collaborations.

Even though VASCEPA has been approved by the U.S. FDA for marketing in the United States for two important indications, recently received marketing authorization in Europe and is approved in smaller jurisdictions, it may not gain enough market acceptance to support profitability. We anticipate continuing to incur significant costs associated with expanding the commercialization of VASCEPA. We may not achieve profitability on a sustained basis in the near term due to high costs associated with, for example, our expanded commercialization ~~efforts.~~efforts in the United States and our expected commercialization efforts in Europe. If we are unable to continue to generate robust product revenues, we will not become profitable on a sustained basis in the near term, if ever, and may be unable to continue operations without continued funding.

Our operating results are unpredictable and may fluctuate. If our operating results are below the expectations of securities analysts or investors, the trading price of our stock could decline.

Our operating results are difficult to predict and will likely fluctuate from quarter to quarter and year to year, and VASCEPA prescription figures will likely fluctuate from month to month. VASCEPA sales are difficult to predict from period to period and as a result, you should not rely on VASCEPA sales results in any period as being indicative of future performance, and sales of VASCEPA may be below the expectation of securities analysts or investors in the future. We believe that our quarterly and annual results of operations may be affected by a variety of factors, including those risks and uncertainties described in this Part II, Item 1A and the following:

We may require substantial additional resources to fund our operations. If we cannot find additional capital resources, we will have difficulty in operating as a going concern and growing our business.

We currently operate with limited resources. We believe that our cash and cash equivalents balance of ~~$214.0~~$291.0 million and short-term investment balance of ~~$336.3~~$213.2 million as of ~~June 30, 2020~~March 31, 2021 will be sufficient to fund our projected operations for at least 12 months. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we expect or fail to achieve positive cash flow. Depending on the level of cash generated from operations, and depending in part on the rate of prescription growth for VASCEPA, additional capital may be required to support planned VASCEPA promotion and potential VASCEPA promotion beyond which we are currently executing and for commercialization of ~~VASCEPA~~VAZKEPA in Europe. If additional capital is required and we are unable to obtain additional capital, we may be forced to delay, limit or eliminate certain promotional activities. We anticipate that quarterly net cash outflows in future periods will be variable as a result of the timing of certain items, including our purchases of API, VASCEPA promotional activities from approval by the U.S. FDA for the new indication and expanded label and the impact from COVID-19 on our operations and those of our customers and any current or potential generic ~~competition as a result of our ANDA litigation.~~competition.

In order to fully realize the market potential of VASCEPA, we may need to enter into a new strategic collaboration or raise additional capital.

If we require additional funds and adequate funds are not available to us in amounts or on terms acceptable to us or on a timely basis, or at all, our commercialization efforts for VASCEPA, and our business generally, may suffer materially.

~~The potential future benefit~~* Changes in tax laws could have a material adverse effect on our business, financial condition and results of our substantial net operating loss carryforwards could be lost and our prospects for profitability could be materially diminished if tax regulations or rates change or if we are deemed to not have active operations in Ireland.operations.

Tax law and policies in the United States and Ireland are unsettled and may be subject to significant change, including based on adjustments in political ~~perspectives.~~perspectives and administration shifts. In the United States and internationally, how to tax entities with international operations, like Amarin, has been subject to significant re-evaluation. We believe we developed VASCEPA in and from Ireland based on understanding of applicable requirements. In recent years, particularly since 2013 when commercial sale of VASCEPA commenced in the United States, the majority of our consolidated operations have been in the United States. Ownership of VASCEPA continues to reside with our wholly-owned Ireland-based subsidiary, Amarin Pharmaceuticals Ireland Ltd., and oversight and operations of that entity are structured to be maintained in Ireland. In order to effectively utilize our accumulated net operating loss carryforwards for tax purposes in Ireland, our operations, particularly for this subsidiary, need to be active in Ireland under applicable requirements. In addition, utilization of these accumulated net operating loss carryforwards assumes that tax treaties between Ireland and other countries, particularly the United States, do not change in a manner that limit our future ability to offset earnings with these operating loss carryforwards for tax purposes.

Similarly, a change in our Irish tax residence could materially affect our ability to obtain and maintain profitability, if otherwise achievable. Changes in tax law and tax rates, particularly in the United States and Ireland, could also impact our assessment of deferred taxes. Any change in our assessment of the realizability or the timing for realizing deferred taxes could have a negative impact our future profitability.

~~Negative economic conditions would likely~~Changes in tax laws (including in response to the COVID-19 pandemic) or tax rulings, or changes in interpretations of existing laws, could cause us to be subject to additional income-based taxes and non-income taxes (such as payroll, sales, use, value-added, digital tax, net worth, property, and goods and services taxes), which in turn could materially affect our financial position and results of operations. In particular, there have been a ~~negative~~number of significant changes to the U.S. federal income tax rules in recent years and additional tax reform proposed by the Biden administration may be enacted. The effect ~~on our ability~~of any such tax reform is uncertain. As we continue to ~~obtain financing on acceptable terms.~~

~~While we may seek additional funding through public or private financings, we may not be able to obtain financing on acceptable terms, or at all. There can be no assurance that~~expand internationally, we will be ~~able~~subject to ~~access equity~~varied and complex tax regimes, and the tax laws of one jurisdiction may impact our expansion to or ~~credit markets~~operations in ~~order to finance~~other jurisdictions. Additionally, new, changed, modified, or newly interpreted or applied tax laws could increase our

~~current operations or expand development programs for VASCEPA, or that there will not be deterioration in financial markets~~ partners’ and ~~confidence in economies, particularly in light of~~our compliance, operating and other costs, as well as the recent volatility attributed to COVID-19. We may also have to scale back or further restructure our operations. If we are unable to obtain additional funding on a timely basis, we may be required to curtail or terminate some or allcosts of our ~~research or development programs or our commercialization strategies.~~

~~Raising additional capital may cause dilution to our existing shareholders, restrict our operations or require us to relinquish rights.~~

Toproducts. As we expand the extent we are permitted under our December 2012 Purchase and Sale Agreement with CPPIB Credit Europe S.à r.l., or CPPIB, as successor in interest to BioPharma Secured Debt Fund II Holdings Cayman LP, we may seek additional capital through a combinationscale of private and public equity offerings, debt financings and collaboration, strategic and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a shareholder.

Debt financing, if available, may involve agreements that include burdensome covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaboration, strategic alliance and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, VASCEPA or product candidates beyond the rights we have already relinquished, or grant licenses on terms that are not favorable to us.

~~Potential business combinations or other strategic transactions may disrupt~~ our business ~~or divert management’s attention.~~

~~On a regular basis, we explore potential business combination transactions, including an acquisition~~activities, any changes in the taxation of ~~us by a third party, exclusive licenses of VASCEPA or other strategic transactions or collaborations with third parties. The consummation~~such activities may increase our effective tax rate and ~~performance of any such future transactions or collaborations will involve risks, such as:~~

As a result of these risks, we may not be able to achieve the expected benefits of any such transaction or collaboration or deliver the value thereof to our shareholders. If we are unsuccessful in consummating any such transaction or collaboration, we may be required to reevaluateharm our business, ~~only after we have incurred substantial expenses~~financial condition, and ~~devoted significant management time and resources.~~results of operations.

The stock market has from time to time experienced significant price and volume fluctuations that may be unrelated to the operating performance of particular companies. In addition, the market prices of the securities of many pharmaceutical and medical technology companies have been especially volatile in the past, and this trend is expected to continue in the future.

As of ~~July 31, 2020,~~April 23, 2021, we had ~~388,673,381~~394,771,523 common shares outstanding including ~~388,472,048~~394,574,581 shares held as ADSs and ~~201,333~~196,942 held as ordinary shares (which are not held in the form of ADSs). There is a risk that there may not be sufficient liquidity in the market to accommodate significant increases in selling activity or the sale of a large block of our securities. Our ADSs have historically had limited trading volume, which may also result in volatility. If any of our large investors seek to sell substantial

amounts of our ADSs, particularly if these sales are in a rapid or disorderly manner, or other investors perceive that these sales could occur, the market price of our ADSs could decrease significantly.

The market price of our ADSs and common shares may also be affected by factors such as:

Further, the United Kingdom ceased to be a member of the European Union on January 31, 2020, commonly referred to as Brexit , and ~~is currently in an~~the 11-month implementation period ~~which will end~~ended on December 31, 2020 and a new trade deal between the United Kingdom and the European Union was agreed to on December 24, 2020. The effects of Brexit ~~remain~~are uncertain and may have a negative effect on global economic conditions, financial markets and our business, which could reduce the price of our ADSs and common shares. In particular, Brexit could lead to a period of considerable uncertainty in relation to the UK financial and banking markets, as well as on the regulatory process in Europe, which could cause the broader global financial markets to experience significant volatility. Asset valuations, currency exchange rates and credit ratings may also be subject to increased market volatility due to the ongoing ~~uncertainty, particularly in regards to whether there will be a trade deal between the UK and the EU.~~uncertainty. Lack of clarity about future UK laws and regulations as the United Kingdom determines which EU rules and regulations to replace or replicate could decrease foreign direct investment in the UK, increase costs, disrupt our business, depress economic activity and restrict our access to capital, any of which could negatively impact the price of our ADSs and common shares.

* The number of our ordinary shares, or ADSs representing such ordinary shares, outstanding may increase substantially as a result of our 2015 private placements and the later consolidation and redesignation of the Series A Preference Shares represented by Preference ADSs issued thereunder, and some of the investors may then beneficially own significant blocks of our ordinary shares; the ordinary shares and Series A Preference Shares resulting from the private placement are generally available for resale in the public market upon consolidation and redesignation.

In March and July 2015, we completed a private placement of American Depositary Shares in two tranches representing 352,150,790 and 38,867,180 Series A Preference Shares, respectively, each ten (10) of which may be consolidated and redesignated into one (1) ordinary share in our capital. During 2015, 62,833,330 Series A Preference Shares were converted, resulting in the issuance of 6,283,333 ordinary shares and during 2018, the entire tranche completed in July 2015 of 38,867,180 Series A Preference Shares was converted, resulting in the issuance of 3,886,718 ordinary shares. In addition, in April and July 2020, 237,713,680 and 27,753,000 preferred shares, respectively, were converted, resulting in the issuance of 23,771,368 and 2,775,300 ordinary shares, respectively. The consolidation and redesignation of the Series A Preference Shares currently outstanding would result in an additional 2,385,078 ordinary shares outstanding, resulting in additional dilution to shareholders. Although the Series A Preference Shares do not have voting rights, in general, upon consolidation and redesignation into ordinary shares, including as a result of the April and July 2020 conversions described above, some of the investors in the private placement could then have significant influence over the outcome of any shareholder vote, including the election of directors and the approval of mergers or other business combination transactions.

Moreover, such securities are or will be generally available for immediate resale in the public market, which could cause the market price of our ordinary shares to fall as a result of an increase in the number of shares available for sale in the public market.

Failure to comply with our obligations under the March 2015 securities subscription agreements could result in our becoming liable for damages to certain investors under these agreements, including specified liquidated damages, which could be material in amount.

Under the terms of the March 2015 securities subscription agreements effecting the private placements described above, we are subject to various obligations, failure to comply with which could result in our becoming liable to certain investors under these agreement for damages, which could be material in amount.

For example, under each of these agreements we have agreed to file and maintain the effectiveness of certain resale registration statements for ADSs representing the ordinary shares underlying the Series A Preference Shares we issued and sold under these agreements. Specifically, we have agreed to pay liquidated damages to the investors in the respective private placements if (a) the applicable resale registration statements we are required to file are not declared effective within 120 days after the closing of the applicable private placement, or (b) after effectiveness and subject to certain specified exceptions, we suspend the use of the applicable registration statement or the registration statement ceases to remain continuously effective as to all the securities for which it is required to be effective. We refer to each of these events as a registration default. Subject to the specified exceptions, for each 30-day period or portion thereof during which a registration default remains uncured, we are obligated to pay liquidated damages to each investor in cash in an amount equal to 1% of the aggregate subscription price paid by each such investor in the private placement, up to a maximum of 8% of such aggregate subscription price. These amounts could be material, and any liquidated damages we are required to pay could have a material adverse effect on our financial condition.

In addition, under the March 2015 securities subscription agreement, we are required to not publicly disclose the identity of the investors party to that agreement, subject to certain exceptions for disclosures required in securities filings and under applicable law. If we fail to comply with these obligations we could become liable to these investors for damages, including specified liquidated damages. For example, following certain public statements made by us on a quarterly conference call concerning the 2015 private placement, we agreed to specified liquidated damages in the event we are found to have violated the confidentiality provisions of the subscription agreement in the future.

Actual or potential sales of our common shares by our employees, including members of our senior management team, pursuant to pre-arranged stock trading plans could cause our stock price to fall or prevent it from increasing for numerous reasons, and actual or potential sales by such persons could be viewed negatively by other investors.

In accordance with the guidelines specified under Rule 10b5-1 of the Securities Exchange Act of 1934 and our policies regarding stock transactions, a number of our directors and employees, including members of our senior management team, have adopted and may continue to adopt pre-arranged stock trading plans to sell a portion of our common stock. Generally, sales under such plans by members of our senior management team and directors require public filings. Actual or potential sales of our ADSs by such persons could cause the price of our ADSs to fall or prevent it from increasing for numerous reasons. For example, a substantial amount of our ADSs becoming available (or being perceived to become available) for sale in the public market could cause the market price of our ADSs to fall or prevent it from increasing. Also, actual or potential sales by such persons could be viewed negatively by other investors.

If we were to be characterized as a passive foreign investment company there could be adverse consequences to U.S. investors.

A non-U.S. corporation will be classified as a passive foreign investment company, or PFIC, for U.S. federal income tax purposes for any taxable year, if either (i) 75% or more of its gross income for such year consists of certain types of “passive” income or (ii) 50% or more of the value of its assets (determined on the basis of a quarterly average) during such year produce or are held for the production of passive income. Passive income generally includes dividends, interest, royalties, rents, annuities, net gains from the sale or exchange of property producing such income and net foreign currency gains. In addition, a non-U.S. corporation will be treated as owning its proportionate share of the assets and earning its proportionate share of the income of any other corporation in which it owns, directly or indirectly, no more than 25% (by value) of the stock.

Based on certain estimates of our gross income and gross assets, the latter determined by reference to the expected value of our ADSs and shares, we believe that we will not be classified as a PFIC for the taxable year ended December 31, ~~2019~~2020 and we do not expect to be treated as a PFIC in any future taxable year for the foreseeable future. However, because PFIC status is based on our income, assets and activities for the entire taxable year, which we expect may vary substantially over time, it is not possible to determine whether we will be characterized as a PFIC for any taxable year until after the close of the taxable year. Moreover, we must determine our PFIC status annually based on tests that are factual in nature, and our status in future years will depend on our income, assets and activities in each of those years. There can be no assurance that we will not be considered a PFIC for any taxable year.

~~Failure to meet our obligations under our December 2012 Purchase and Sale Agreement could adversely affect our financial results and liquidity.~~

Pursuant to our December 2012 Purchase and Sale Agreement with CPPIB, which was assigned to CPPIB by BioPharma Secured Debt Fund II Holdings Cayman LP in December 2017, we are obligated to make payments based on the amount of our net product sales of VASCEPA and any future products based on ethyl-EPA, or covered products, subject to certain quarterly caps.

Pursuant to this agreement, we may not, among other things: (i) incur indebtedness greater than a specified amount, which we refer to as the Indebtedness Covenant; (ii) pay a dividend or other cash distribution, unless we have cash and cash equivalents in excess of a specified amount after such payment; (iii) amend or restate our memorandum and articles of association unless such amendments or restatements do not affect CPPIB’s interests under the transaction; (iv) encumber any of the collateral securing our performance under the agreement; and (v) abandon certain patent rights, in each case without the consent of CPPIB.

Upon a transaction resulting in a change of control of Amarin, as defined in the agreement, CPPIB will be automatically entitled to receive any amounts not previously paid, up to our maximum repayment obligation. As defined in the agreement, “change of control” includes, among other things, (i) a greater than 50 percent change in the ownership of Amarin, (ii) a sale or disposition of any collateral securing our debt with CPPIB and (iii), unless CPPIB has been paid a certain amount under the indebtedness, certain licensings of VASCEPA to a third party for sale in the United States. The acceleration of the payment obligation in the event of a change of control transaction may make us less attractive to potential acquirers, and the payment of such funds out of our available cash or acquisition proceeds would reduce acquisition proceeds for our shareholders.

To secure our obligations under the agreement, we granted CPPIB a security interest in our rights in patents, trademarks, trade names, domain names, copyrights, know-how and regulatory approvals related to the covered products, all books and records relating to the foregoing and all proceeds of the foregoing, which we refer to as the collateral. If we (i) fail to deliver a payment when due and do not remedy that failure within specific notice period, (ii) fail to maintain a first-priority perfected security interest in the collateral in the United States and do not remedy that failure after receiving notice of such failure or (iii) become subject to an event of bankruptcy, then CPPIB may attempt to collect the maximum amount payable by us under this agreement (after deducting any payments we have already made).

There can be no assurance that we will not breach the covenants or other terms of, or that an event of default will not occur under, this agreement and, if a breach or event of default occurs, there can be no assurance that we will be able to cure the breach within the time permitted. Any failure to pay our obligations when due, any breach or default of our covenants or other obligations, or any other event that causes an acceleration of payment at a time when we do not have sufficient resources to meet these obligations, could have a material adverse effect on our business, results of operations, financial condition and future viability.

~~Our indebtedness and the related annual debt service requirements, if any, may adversely impact our business, operations and financial condition in the future. For example, they could:~~

We do not intend to pay cash dividends on the ordinary shares in the foreseeable future.

We have never paid dividends on ordinary shares and do not anticipate paying any cash dividends on the ordinary shares in the foreseeable future. Under English law, any payment of dividends would be subject to relevant legislation and our Articles of Association, which requires that all dividends must be approved by our Board of Directors and, in some cases, our shareholders, and may only be paid from our distributable profits available for the purpose, determined on an unconsolidated basis.

The rights of our shareholders may differ from the rights typically offered to shareholders of a U.S. corporation.

We are incorporated under English law. The rights of holders of ordinary shares and, therefore, certain of the rights of holders of ADSs, are governed by English law, including the provisions of the Companies Act 2006, and by our Articles of Association. These rights differ in certain respects from the rights of shareholders in typical U.S. corporations. The principal differences include the following:

Shareholder protections found in provisions under the ~~U.K.~~UK City Code on Takeovers and Mergers, or the Takeover Code, do not apply to us.

The Takeover Code provides a framework within which takeovers of certain companies organized in the United Kingdom are regulated and conducted. However, because our place of central management and control is currently outside of the United Kingdom, we are not subject to the Takeover Code. As a result, our shareholders are not entitled to the benefit of certain takeover offer

protections provided under the Takeover Code. The following is a brief summary of some of the most important rules of the Takeover Code which, as noted, does not apply to us:

We are incorporated under the laws of England and Wales, and our subsidiaries are incorporated in various jurisdictions, including foreign jurisdictions. A number of the officers and directors of each of our subsidiaries are non-residents of the United States, and all or a substantial portion of the assets of such persons are located outside the United States. As a result, it may not be possible for investors to affect service of process within the United States upon such persons or to enforce against them judgments obtained in U.S. courts predicated upon the civil liability provisions of the federal securities laws of the United States. We have been advised by our English solicitors that there is doubt as to the enforceability in England in original actions, or in actions for enforcement of judgments of U.S. courts, of civil liabilities to the extent predicated upon the federal securities laws of the United States.

U.S. holders of the ADSs or ordinary shares may be subject to U.S. federal income taxation at ordinary income tax rates on undistributed earnings and profits.

There is a risk that we will be classified as a controlled foreign corporation, or CFC, for U.S. federal income tax purposes. If we are classified as a CFC, any ADS holder or shareholder that is a U.S. person that owns directly, indirectly or by attribution, 10% or more of the voting power of our outstanding shares may be subject to U.S. income taxation at ordinary income tax rates on all or a portion of our undistributed earnings and profits attributable to “subpart F income.” Such 10% holder may also be taxable at ordinary income tax rates on any gain realized on a sale of ordinary shares or ADS, to the extent of our current and accumulated earnings and profits attributable to such shares. The CFC rules are complex and U.S. holders of the ordinary shares or ADSs are urged to consult their own tax advisors regarding the possible application of the CFC rules to them in their particular circumstances.

Potential technological changes in our field of business create considerable uncertainty.

The pharmaceutical industry in which we operate is characterized by extensive research efforts and rapid technological progress. New developments in research are expected to continue at a rapid pace in both industry and academia. We cannot assure you that research and discoveries by others will not render some or all of our programs or product candidates uncompetitive or obsolete. Our business strategy is based in part upon new and unproven technologies to the development of therapeutics to improve cardiovascular health. We cannot assure you that unforeseen problems will not develop with these technologies or applications or that any commercially feasible products will ultimately be developed by us.

Legal, political and economic uncertainty surrounding the exit of the UK from the EU may be a source of instability in international markets, create significant currency fluctuations, adversely affect our operations in the UK and pose additional risks to our business, revenue, financial condition, and results of operations.

On June 23, 2016, the UK held a referendum in which a majority of the eligible members of the electorate voted to leave the EU, commonly referred to as Brexit. The UK formally left the EU on January 31, 2020 when the transition period granted by the Withdrawal Agreement ended. Separately, the EU-UK Trade and Cooperation Agreement was entered into between the UK and the EU on December 24, 2020. In addition, the UK is negotiating deals in a number of other areas where cooperation with the EU is required, and there is continued uncertainty as to which EU regulations and directives will be replicated into UK domestic law, or replaced, going forward, and when. Given the recent deal terms and the lack of clarity on future UK laws and regulations and their divergence from, or consistency with, the EU laws and regulations may negatively impact foreign direct investment in the UK, increase costs, depress economic activity and restrict access to capital.

If the UK and the EU are unable to implement acceptable agreements or if other EU member states pursue withdrawal, barrier-free access between the UK and other EU member states or among the European Economic Area, or EEA, overall could be diminished or eliminated. The long-term effects of Brexit will depend on any agreements (or lack thereof) between the UK and the EU.

impact our current and future operations (including business activities conducted by third parties and contract manufacturers on our behalf) and clinical activities in the UK. In addition to the foregoing, our UK operations support our current and future operations and clinical activities in other countries in the EU and EEA and these operations and clinical activities could be disrupted by the ongoing effects of Brexit, particularly in regards to the specific terms of any trade deal that is reached between the UK and the EU.

We may also face new regulatory costs and challenges that could have an adverse effect on our operations. The impact of the terms of the recent trade deal between the UK and EU are uncertain. Since the regulatory framework in the UK covering quality, safety and efficacy of pharmaceutical products, clinical trials, marketing authorization, commercial sales and distribution of pharmaceutical products is derived from EU directives and regulations, Brexit could materially impact the future regulatory regime with respect to the commercialization of our products in the UK. Any delay in commercializing our products in the UK and/or the EU could restrict our ability to generate revenue and achieve and sustain profitability. The uncertainty around the UK’s future relationship with the EU continues to cause economic uncertainty which could adversely impact customer confidence resulting in customers reducing their spending budgets on our solutions, which could adversely affect our business, revenue, financial condition, results of operations and could adversely affect the market price of our ADSs.

Negative economic conditions would likely have a negative effect on our ability to obtain financing on acceptable terms.

While we may seek additional funding through public or private financings, we may not be able to obtain financing on acceptable terms, or at all. There can be no assurance that we will be able to access equity or credit markets in order to finance our current operations or expand development programs for VASCEPA, or that there will not be deterioration in financial markets and confidence in economies, particularly in light of the continued volatility attributed to COVID-19. We may also have to scale back or further restructure our operations. If we are unable to obtain additional funding on a timely basis, we may be required to curtail or terminate some or all of our research or development programs or our commercialization strategies.

Raising additional capital may cause dilution to our existing shareholders, restrict our operations or require us to relinquish rights.

We may seek additional capital through a combination of private and public equity offerings, debt financings and collaboration, strategic and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a shareholder.

Potential business combinations or other strategic transactions may disrupt our business or divert management’s attention.

On a regular basis, we explore potential business combination transactions, including an acquisition of us by a third party, exclusive licenses of VASCEPA or other strategic transactions or collaborations with third parties. The consummation and performance of any such future transactions or collaborations will involve risks, such as:

As a result of these risks, we may not be able to achieve the expected benefits of any such transaction or collaboration or deliver the value thereof to our shareholders. If we are unsuccessful in consummating any such transaction or collaboration, we may be required to reevaluate our business only after we have incurred substantial expenses and devoted significant management time and resources.

The following exhibits are incorporated by reference or filed or furnished as part of this report.

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

		Page

	PART I – Financial Information

Item 1.	Financial Statements (unaudited):
	Condensed Consolidated Balance Sheets as of ~~June 30, 2020~~March 31, 2021 and December 31, ~~2019~~2020	3
	Condensed Consolidated Statements of Operations for the three ~~and six~~ months ended ~~June 30,~~March 31, 2021 and 2020 ~~and 2019~~	4
	Condensed Consolidated Statement of Changes in Stockholders’ Equity ~~(Deficit)~~ for the ~~six~~three months ended ~~June 30,~~March 31, 2021 and 2020 ~~and 2019~~	5
	Condensed Consolidated Statements of Cash Flows for the ~~six~~three months ended ~~June 30,~~March 31, 2021 and 2020 ~~and 2019~~	6
	Notes to Condensed Consolidated Financial Statements	7
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	2524
Item 3.	Quantitative and Qualitative Disclosures about Market Risk	4035
Item 4.	Controls and Procedures	4035

	PART II – Other Information

Item 1.	Legal Proceedings	4236
Item 1A.	Risk Factors	4236
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	8478
Item 5.	Other Information	78
Item 6.	Exhibits	8579

SIGNATURES		8680

In thousands	June 30, 2020			December 31, 2019			March 31, 2021			December 31, 2020
Gross trade accounts receivable	$	173,186		$	149,567		$	220,215		$	203,875
Trade allowances		(36,826	)		(29,261	)		(54,708	)		(36,242	)
Chargebacks		(10,430	)		(3,876	)		(13,287	)		(12,114	)
Allowance for doubtful accounts		(945	)		—			(945	)		(945	)
Accounts receivable, net	$	124,985		$	116,430		$	151,275		$	154,574

In thousands	June 30, 2020		December 31, 2019		March 31, 2021		December 31, 2020
Raw materials	$	29,122	$	19,455	$	69,463	$	50,657
Work in process		30,056		12,031		36,094		30,388
Finished goods		65,666		45,283		125,335		107,819
Total inventory	$	124,844	$	76,769	$	230,892	$	188,864

In thousands	Three Months Ended March 31,
Revenue recognized in the period from:	2021		2020
Amounts included in contract liability at the beginning of the period	$	662	$	1,390
Performance obligations satisfied in previous periods	$	—	$	1,097

In thousands	Six Months Ended June 30,
Revenue recognized in the period from:	2020		2019
Amounts included in contract liability at the beginning of the period	$	2,845	$	973
Performance obligations satisfied in previous periods	$	1,097	$	—

Large accelerated filer	☒	Accelerated filer	☐

Non-accelerated filer	☐	Smaller reporting company	☐

Emerging growth company	☐

	Undiscounted lease payments ($000s)			Undiscounted lease payments ($000s)
Remainder of 2020	$	390
2021		1,495
Remainder of 2021				$	1,134
2022		1,776			1,774
2023		1,809			1,808
2024		1,843			1,842
2025 and thereafter		10,910
2025					1,876
2026 and thereafter					9,112
Total undiscounted payments	$	18,223		$	17,546
Discount Adjustments	$	(7,811	)	$	(6,956	)
Current operating lease liability	$	1,101		$	1,575
Long-term operating lease liability	$	9,311		$	9,015

	Six months ended June 30,						Three months ended March 31,
In millions	2020			2019			2021			2020
Cash provided by (used in):
Operating activities	$	5.7		$	(22.2	)	$	(18.7	)	$	4.1
Investing activities		(396.3	)		(0.8	)		127.9			(293.8	)
Financing activities		(40.0	)		(4.5	)		(5.2	)		(25.9	)
Decrease in cash and cash equivalents and restricted cash	$	(430.6	)	$	(27.5	)
Increase (decrease) in cash and cash equivalents and restricted cash							$	104.0		$	(315.5	)

Period	Total Number of Shares Purchased ⁽¹⁾		Average Price Paid per Share
April 1 – 30, 2020		19,328	$	8.26
May 1 – 31, 2020		32,133		7.16
June 1 – 30, 2020		19,510		6.72
Total		70,971	$	7.34

Exhibit Number	Description	Incorporated by Reference Herein
Exhibit Number	Description	Form	Date

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

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

10.3	Amarin Corporation plc Executive Severance and Change of Control Plan	Current Report on Form 8-K dated January 29, 2021, Nile No. 0-21392, as Exhibit 10.1	January 29, 2021

10.4	Contract of Employment between Karim Mikhail and Amarin Switzerland GmbH, dated April 12, 2021	Filed herewith

31.1	Certification of President and Chief Executive Officer (Principal Executive Officer) pursuant to Section 302 of Sarbanes-Oxley Act of 2002	Filed herewith

31.2	Certification of Senior Vice President and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) pursuant to Section 302 of Sarbanes-Oxley Act of 2002	Filed herewith

32.1	Certification of President and Chief Executive Officer (Principal Executive Officer) and Senior Vice President and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) pursuant to Section 906 of Sarbanes-Oxley Act of 2002	Furnished herewith


101.SCH	Inline XBRL Taxonomy Extension Schema Document	Filed herewith

101.CAL	Inline XBRL Taxonomy Extension Calculation Linkbase Document	Filed herewith

101.DEF	Inline XBRL Taxonomy Extension Definition Linkbase Document	Filed herewith

101.LAB	Inline XBRL Taxonomy Extension Label Linkbase Document	Filed herewith

101.PRE	Inline XBRL Taxonomy Extension Presentation Linkbase Document	Filed herewith

104	Cover Page Interactive Data File ~~(formatted~~ (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101.*)	Filed herewith

AMARIN CORPORATION PLC

By:		/s/ John F. Thero
		John F. Thero

		President and Chief Executive Officer
		(Principal Executive Officer)
		(On behalf of the Registrant)