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UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

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

For the quarterly period ended September 30, 2021

OR

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

For the transition period from to

Commission File No. 000-21392

 

Amarin Corporation plc

(Exact Name of Registrant as Specified in its Charter)

 

 

England and Wales

 

Not applicable

(State or Other Jurisdiction of

Incorporation or Organization)

 

(I.R.S. Employer

Identification No.)

 

77 Sir John Rogerson’s Quay, Block C,

Grand Canal Docklands

 

Dublin 2, Ireland

(Address of Principal Executive Offices)

 

(Zip Code)

 

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

 

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

 

Title of each class

Trading Symbol

Name of each exchange on which registered

American Depositary Shares (ADS(s)), each ADS
representing the right to receive one (1) Ordinary Share of

Amarin Corporation plc

AMRN

NASDAQ Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YesNo

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). YesNo

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

 

Large accelerated filer

 

 

Accelerated filer

 

 

 

 

 

 

Non-accelerated filer

 

 

Smaller reporting company

 

 

 

 

 

 

Emerging growth company

 

 

 

 

 

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

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). YesNo

395,825,887 common shares were outstanding as of October 29, 2021, including 395,629,060 shares held as American Depositary Shares (ADSs), each representing one Ordinary Share, 50 pence par value per share and 196,827 Ordinary Shares.

 

 

 


 

INDEX TO FORM 10-Q

 

 

 

 

 

Page

 

 

 

PART I – Financial Information

 

 

 

Item 1.

 

Financial Statements (unaudited):

 

 

 

 

Condensed Consolidated Balance Sheets as of September 30, 2021 and December 31, 2020

 

3

 

 

Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2021 and 2020

 

4

 

 

Condensed Consolidated Statement of Changes in Stockholders’ Equity for the nine months ended September 30, 2021 and 2020

 

5

 

 

Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2021 and 2020

 

6

 

 

Notes to Condensed Consolidated Financial Statements

 

7

Item 2.

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

25

Item 3.

 

Quantitative and Qualitative Disclosures about Market Risk

 

40

Item 4.

 

Controls and Procedures

 

40

 

 

 

PART II – Other Information

 

 

 

Item 1.

 

Legal Proceedings

 

41

Item 1A.

 

Risk Factors

 

41

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

 

83

Item 5.

 

Other Information

 

83

Item 6.

 

Exhibits

 

84

 

SIGNATURES

 

85

 

 

2


 

PART I

AMARIN CORPORATION PLC

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited, in thousands, except share amounts)

 

 

 

 

September 30, 2021

 

 

December 31, 2020

 

ASSETS

 

 

 

 

 

 

Current Assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

222,875

 

 

$

186,964

 

Restricted cash

 

 

3,917

 

 

 

3,915

 

Short-term investments

 

 

256,267

 

 

 

313,969

 

Accounts receivable, net

 

 

149,361

 

 

 

154,574

 

Inventory

 

 

309,268

 

 

 

188,864

 

Prepaid and other current assets

 

 

21,345

 

 

 

30,947

 

Total current assets

 

 

963,033

 

 

 

879,233

 

Property, plant and equipment, net

 

 

1,569

 

 

 

2,016

 

Long-term investments

 

 

38,802

 

 

 

62,469

 

Operating lease right-of-use asset

 

 

7,762

 

 

 

8,054

 

Other long-term assets

 

 

456

 

 

 

432

 

Intangible asset, net

 

 

24,183

 

 

 

13,817

 

TOTAL ASSETS

 

$

1,035,805

 

 

$

966,021

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

 

Accounts payable

 

$

72,415

 

 

$

105,876

 

Accrued expenses and other current liabilities

 

 

289,684

 

 

 

198,641

 

Current deferred revenue

 

 

2,646

 

 

 

2,926

 

Total current liabilities

 

 

364,745

 

 

 

307,443

 

Long-Term Liabilities:

 

 

 

 

 

 

Long-term deferred revenue

 

 

14,486

 

 

 

15,706

 

Long-term operating lease liability

 

 

8,729

 

 

 

9,153

 

Other long-term liabilities

 

 

5,350

 

 

 

6,214

 

Total liabilities

 

 

393,310

 

 

 

338,516

 

Commitments and contingencies (Note 5)

 

 

 

 

 

 

Stockholders’ Equity:

 

 

 

 

 

 

Common stock, £0.50 par, unlimited authorized; 402,772,229 shares issued, 395,613,406 shares outstanding as of September 30, 2021; 398,425,000 shares issued, 392,538,081 shares outstanding as of December 31, 2020

 

 

293,140

 

 

 

290,115

 

Additional paid-in capital

 

 

1,845,103

 

 

 

1,817,649

 

Treasury stock; 7,158,823 shares as of September 30, 2021; 5,886,919 shares as of December 31, 2020

 

 

(59,602

)

 

 

(51,082

)

Accumulated deficit

 

 

(1,436,146

)

 

 

(1,429,177

)

Total stockholders’ equity

 

 

642,495

 

 

 

627,505

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

1,035,805

 

 

$

966,021

 

 

See notes to condensed consolidated financial statements.

3


 

AMARIN CORPORATION PLC

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited, in thousands, except per share amounts)

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Product revenue, net

$

141,442

 

 

$

155,190

 

 

$

436,598

 

 

$

441,118

 

Licensing and royalty revenue

 

596

 

 

 

1,309

 

 

 

2,098

 

 

 

5,691

 

Total revenue, net

 

142,038

 

 

 

156,499

 

 

 

438,696

 

 

 

446,809

 

Less: Cost of goods sold

 

30,211

 

 

 

33,071

 

 

 

90,692

 

 

 

96,676

 

Gross margin

 

111,827

 

 

 

123,428

 

 

 

348,004

 

 

 

350,133

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

102,965

 

 

 

120,164

 

 

 

315,966

 

 

 

346,496

 

Research and development

 

7,820

 

 

 

10,204

 

 

 

23,554

 

 

 

30,450

 

Restructuring

 

14,115

 

 

 

 

 

 

14,115

 

 

 

 

Total operating expenses

 

124,900

 

 

 

130,368

 

 

 

353,635

 

 

 

376,946

 

Operating loss

 

(13,073

)

 

 

(6,940

)

 

 

(5,631

)

 

 

(26,813

)

Interest income, net

 

163

 

 

 

549

 

 

 

919

 

 

 

1,908

 

Other (expense) income, net

 

(57

)

 

 

33

 

 

 

(390

)

 

 

50

 

Loss from operations before taxes

 

(12,967

)

 

 

(6,358

)

 

 

(5,102

)

 

 

(24,855

)

Income tax (provision) benefit

 

(184

)

 

 

(430

)

 

 

(1,867

)

 

 

1,929

 

Net loss

$

(13,151

)

 

$

(6,788

)

 

$

(6,969

)

 

$

(22,926

)

Loss per share:

 

 

 

 

 

 

 

 

 

 

 

Basic

$

(0.03

)

 

$

(0.02

)

 

$

(0.02

)

 

$

(0.06

)

Diluted

$

(0.03

)

 

$

(0.02

)

 

$

(0.02

)

 

$

(0.06

)

Weighted average shares:

 

 

 

 

 

 

 

 

 

 

 

Basic

 

396,618

 

 

 

389,699

 

 

 

395,681

 

 

 

378,770

 

Diluted

 

396,618

 

 

 

389,699

 

 

 

395,681

 

 

 

378,770

 

 

See notes to condensed consolidated financial statements.

4


 

AMARIN CORPORATION PLC

CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY

(Unaudited, in thousands, except share amounts)

 

 

 

Preferred
Shares

 

 

Common
Shares

 

 

Treasury
Shares

 

 

Preferred
Stock

 

 

Common
Stock

 

 

Additional
Paid-in
Capital

 

 

Treasury
Stock

 

 

Accumulated
Deficit

 

 

Total

 

December 31, 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

 

Issuance of common stock under employee stock purchase plan

 

 

 

 

 

226,402

 

 

 

 

 

 

 

 

 

161

 

 

 

867

 

 

 

 

 

 

 

 

 

1,028

 

Exercise of stock options

 

 

 

 

 

27,139

 

 

 

 

 

 

 

 

 

19

 

 

 

56

 

 

 

 

 

 

 

 

 

75

 

Vesting of restricted stock units

 

 

 

 

 

346,010

 

 

 

(142,204

)

 

 

 

 

 

242

 

 

 

(242

)

 

 

(677

)

 

 

 

 

 

(677

)

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,479

 

 

 

 

 

 

 

 

 

2,479

 

Income for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

7,808

 

 

 

7,808

 

June 30, 2021

 

 

 

 

 

402,255,276

 

 

 

(7,033,088

)

 

$

 

 

$

292,782

 

 

$

1,834,548

 

 

$

(59,011

)

 

$

(1,422,995

)

 

$

645,324

 

Exercise of stock options

 

 

 

 

 

184,462

 

 

 

 

 

 

 

 

 

128

 

 

 

353

 

 

 

 

 

 

 

 

 

481

 

Vesting of restricted stock units

 

 

 

 

 

332,491

 

 

 

(125,735

)

 

 

 

 

 

230

 

 

 

(230

)

 

 

(591

)

 

 

 

 

 

(591

)

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

10,432

 

 

 

 

 

 

 

 

 

10,432

 

Loss for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(13,151

)

 

 

(13,151

)

September 30, 2021

 

 

 

 

 

402,772,229

 

 

 

(7,158,823

)

 

$

 

 

$

293,140

 

 

$

1,845,103

 

 

$

(59,602

)

 

$

(1,436,146

)

 

$

642,495

 

 

 

 

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

 

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

 

Issuance of common stock under employee stock purchase plan

 

 

 

 

 

123,608

 

 

 

 

 

 

 

 

 

76

 

 

 

772

 

 

 

 

 

 

 

 

 

848

 

Conversion of Series A Convertible 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

 

Income for the period