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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, 2020

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.    YES      NO  

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

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

 

Large accelerated filer

 

 

Accelerated filer

 

 

 

 

 

 

Non-accelerated filer

 

  

 

Smaller reporting company

 

 

 

 

 

 

Emerging growth company

 

 

 

 

 

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

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

388,829,403 common shares were outstanding as of October 30, 2020, including 388,629,254 shares held as American Depositary Shares (ADSs), each representing one Ordinary Share, 50 pence par value per share and 200,149 Ordinary Shares. In addition, 2,385,078 ordinary share equivalents were issuable in exchange for outstanding preferred shares as of October 30, 2020, for a total of 391,214,481 ordinary shares and ordinary share equivalents outstanding as of October 30, 2020.

 


INDEX TO FORM 10-Q

 

 

 

 

 

Page

 

 

 

PART I – Financial Information

 

 

 

Item 1.

 

Financial Statements (unaudited):

 

 

 

 

Condensed Consolidated Balance Sheets as of September 30, 2020 and December 31, 2019

 

3

 

 

Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2020 and 2019

 

4

 

 

Condensed Consolidated Statement of Changes in Stockholders’ Equity for the nine months ended September 30, 2020 and 2019

 

5

 

 

Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2020 and 2019

 

7

 

 

Notes to Condensed Consolidated Financial Statements

 

8

Item 2.

 

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

 

27

Item 3.

 

Quantitative and Qualitative Disclosures about Market Risk

 

43

Item 4.

 

Controls and Procedures

 

43

 

 

 

PART II – Other Information

 

 

 

Item 1.

 

Legal Proceedings

 

45

Item 1A.

 

Risk Factors

 

45

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

 

87

Item 6.

 

Exhibits

 

88

 

SIGNATURES

 

89

 

   2


PART I

AMARIN CORPORATION PLC

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited, in thousands, except share amounts)

 

 

 

September 30, 2020

 

 

December 31, 2019

 

ASSETS

 

 

 

 

 

 

 

 

Current Assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

207,207

 

 

$

644,588

 

Restricted cash

 

 

3,915

 

 

 

3,907

 

Short-term investments

 

 

354,655

 

 

 

 

Accounts receivable, net

 

 

147,292

 

 

 

116,430

 

Inventory

 

 

148,531

 

 

 

76,769

 

Prepaid and other current assets

 

 

26,945

 

 

 

13,311

 

Total current assets

 

 

888,545

 

 

 

855,005

 

Property, plant and equipment, net

 

 

2,166

 

 

 

2,361

 

Long-term investments

 

 

46,092

 

 

 

 

Operating lease right-of-use asset

 

 

8,149

 

 

 

8,511

 

Other long-term assets

 

 

1,074

 

 

 

1,074

 

Intangible asset, net

 

 

14,177

 

 

 

15,258

 

TOTAL ASSETS

 

$

960,203

 

 

$

882,209

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

121,366

 

 

$

49,950

 

Accrued expenses and other current liabilities

 

 

189,650

 

 

 

139,826

 

Debt from royalty-bearing instrument

 

 

9,467

 

 

 

50,130

 

Deferred revenue, current

 

 

5,706

 

 

 

2,342

 

Total current liabilities

 

 

326,189

 

 

 

242,248

 

Long-Term Liabilities:

 

 

 

 

 

 

 

 

Deferred revenue, long-term

 

 

13,199

 

 

 

18,504

 

Long-term operating lease liability

 

 

9,255

 

 

 

9,443

 

Other long-term liabilities

 

 

4,303

 

 

 

3,751

 

Total liabilities

 

 

352,946

 

 

 

273,946

 

Commitments and contingencies (Note 6)

 

 

 

 

 

 

 

 

Stockholders’ Equity:

 

 

 

 

 

 

 

 

Series A Convertible Preferred Stock, £0.05 par, unlimited authorized; 23,850,780 shares issued and outstanding as of September 30, 2020 (equivalent to 2,385,078 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)

 

 

5,434

 

 

 

21,850

 

Common stock, £0.50 par, unlimited authorized; 394,642,079 issued, 388,828,694 outstanding as of September 30, 2020; 365,014,893 issued, 360,103,901 outstanding as of December 31, 2019

 

 

287,585

 

 

 

269,173

 

Additional paid-in capital

 

 

1,799,069

 

 

 

1,764,317

 

Treasury stock; 5,813,385 shares as of September 30, 2020; 4,910,992 shares as of December 31, 2019

 

 

(50,728

)

 

 

(35,900

)

Accumulated deficit

 

 

(1,434,103

)

 

 

(1,411,177

)

Total stockholders’ equity

 

 

607,257

 

 

 

608,263

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

960,203

 

 

$

882,209

 

 

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,

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Product revenue, net

$

155,190

 

 

$

112,250

 

 

$

441,118

 

 

$

285,347

 

Licensing and royalty revenue

 

1,309

 

 

 

158

 

 

 

5,691

 

 

 

1,131

 

Total revenue, net

 

156,499

 

 

 

112,408

 

 

 

446,809

 

 

 

286,478

 

Less: Cost of goods sold

 

33,071

 

 

 

25,444

 

 

 

96,676

 

 

 

65,354

 

Gross margin

 

123,428

 

 

 

86,964

 

 

 

350,133

 

 

 

221,124

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

120,164

 

 

 

82,559

 

 

 

346,496

 

 

 

227,598

 

Research and development

 

10,204

 

 

 

8,923

 

 

 

30,450

 

 

 

23,295

 

Total operating expenses

 

130,368

 

 

 

91,482

 

 

 

376,946

 

 

 

250,893

 

Operating loss

 

(6,940

)

 

 

(4,518

)

 

 

(26,813

)

 

 

(29,769

)

Interest income, net

 

549

 

 

 

1,146

 

 

 

1,908

 

 

 

238

 

Other income (expense), net

 

33

 

 

 

(90

)

 

 

50

 

 

 

(182

)

Loss from operations before taxes

 

(6,358

)

 

 

(3,462

)

 

 

(24,855

)

 

 

(29,713

)

Income tax (provision) benefit

 

(430

)

 

 

 

 

 

1,929

 

 

 

 

Net loss

$

(6,788

)

 

$

(3,462

)

 

$

(22,926

)

 

$

(29,713

)

Loss per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

$

(0.02

)

 

$

(0.01

)

 

$

(0.06

)

 

$

(0.09

)

Diluted

$

(0.02

)

 

$

(0.01

)

 

$

(0.06

)

 

$

(0.09

)

Weighted average shares:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

389,699

 

 

 

350,994

 

 

 

378,770

 

 

 

336,938

 

Diluted

 

389,699

 

 

 

350,994

 

 

 

378,770

 

 

 

336,938

 

 

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, 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

 

Conversion of Series A Convertible Preferred Stock, net

 

 

(27,753,000

)

 

 

2,775,300

 

 

 

 

 

 

(1,732

)

 

 

1,732

 

 

 

(28

)

 

 

 

 

 

 

 

 

(28

)

Exercise of stock options

 

 

 

 

 

82,001

 

 

 

 

 

 

 

 

 

53

 

 

 

150

 

 

 

 

 

 

 

 

 

203

 

Vesting of restricted stock units

 

 

 

 

 

195,466

 

 

 

(71,590

)

 

 

 

 

 

128

 

 

 

(128

)

 

 

(476

)

 

 

 

 

 

(476

)

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

11,583

 

 

 

 

 

 

 

 

 

11,583

 

Net Loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(6,788

)

 

 

(6,788

)

September 30, 2020

 

 

23,850,780

 

 

 

394,642,079

 

 

 

(5,813,385

)

 

$

5,434

 

 

$

287,585

 

 

$

1,799,069

 

 

$

(50,728

)

 

$

(1,434,103

)

 

$

607,257

 

See notes to condensed consolidated financial statements.

   5


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, 2018

 

 

289,317,460

 

 

 

329,110,863

 

 

 

(3,260,850

)

 

$

21,850

 

 

$

246,663

 

 

$

1,282,762

 

 

$

(10,413

)

 

$

(1,388,532

)

 

$

152,330

 

Exercise of stock options

 

 

 

 

 

3,838,739

 

 

 

 

 

 

 

 

 

2,496

 

 

 

12,960

 

 

 

 

 

 

 

 

 

15,456

 

Vesting of restricted stock units

 

 

 

 

 

1,416,124

 

 

 

(526,708

)

 

 

 

 

 

929

 

 

 

(929

)

 

 

(9,080

)

 

 

 

 

 

(9,080

)

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6,596

 

 

 

 

 

 

 

 

 

6,596

 

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