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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 June 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  

388,673,381 common shares were outstanding as of July 31, 2020, including 388,472,048 shares held as American Depositary Shares (ADSs), each representing one Ordinary Share, 50 pence par value per share and 201,333 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.

 


INDEX TO FORM 10-Q

 

 

 

 

 

Page

 

 

 

PART I – Financial Information

 

 

 

Item 1.

 

Financial Statements (unaudited):

 

 

 

 

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

 

3

 

 

Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2020 and 2019

 

4

 

 

Condensed Consolidated Statement of Changes in Stockholders’ Equity (Deficit) for the six months ended June 30, 2020 and 2019

 

5

 

 

Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 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

 

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

 

42

Item 1A.

 

Risk Factors

 

42

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

 

84

Item 6.

 

Exhibits

 

85

 

SIGNATURES

 

86

 

   2


PART I

AMARIN CORPORATION PLC

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited, in thousands, except share amounts)

 

 

 

June 30, 2020

 

 

December 31, 2019

 

ASSETS

 

 

 

 

 

 

 

 

Current Assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

214,007

 

 

$

644,588

 

Restricted cash

 

 

3,913

 

 

 

3,907

 

Short-term investments

 

 

336,273

 

 

 

 

Accounts receivable, net

 

 

124,985

 

 

 

116,430

 

Inventory

 

 

124,844

 

 

 

76,769

 

Prepaid and other current assets

 

 

23,589

 

 

 

13,311

 

Total current assets

 

 

827,611

 

 

 

855,005

 

Property, plant and equipment, net

 

 

2,316

 

 

 

2,361

 

Long-term investments

 

 

61,039

 

 

 

 

Operating lease right-of-use asset

 

 

8,291

 

 

 

8,511

 

Other long-term assets

 

 

1,074

 

 

 

1,074

 

Intangible asset, net

 

 

14,538

 

 

 

15,258

 

TOTAL ASSETS

 

$

914,869

 

 

$

882,209

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

86,757

 

 

$

49,950

 

Accrued expenses and other current liabilities

 

 

168,549

 

 

 

139,826

 

Debt from royalty-bearing instrument

 

 

22,455

 

 

 

50,130

 

Deferred revenue, current

 

 

5,706

 

 

 

2,342

 

Total current liabilities

 

 

283,467

 

 

 

242,248

 

Long-Term Liabilities:

 

 

 

 

 

 

 

 

Deferred revenue, long-term

 

 

14,507

 

 

 

18,504

 

Long-term operating lease liability

 

 

9,311

 

 

 

9,443

 

Other long-term liabilities

 

 

4,821

 

 

 

3,751

 

Total liabilities

 

 

312,106

 

 

 

273,946

 

Commitments and contingencies (Note 6)

 

 

 

 

 

 

 

 

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

 

Additional paid-in capital

 

 

1,787,492

 

 

 

1,764,317

 

Treasury stock; 5,741,795 shares as of June 30, 2020; 4,910,992 shares as of December 31, 2019

 

 

(50,252

)

 

 

(35,900

)

Accumulated deficit

 

 

(1,427,315

)

 

 

(1,411,177

)

Total stockholders’ equity

 

 

602,763

 

 

 

608,263

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

914,869

 

 

$

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 June 30,

 

 

Six months ended June 30,

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Product revenue, net

$

133,724

 

 

$

100,366

 

 

$

285,928

 

 

$

173,097

 

Licensing and royalty revenue

 

1,593

 

 

 

426

 

 

 

4,382

 

 

 

973

 

Total revenue, net

 

135,317

 

 

 

100,792

 

 

 

290,310

 

 

 

174,070

 

Less: Cost of goods sold

 

28,797

 

 

 

22,770

 

 

 

63,604

 

 

 

39,910

 

Gross margin

 

106,520

 

 

 

78,022

 

 

 

226,706

 

 

 

134,160

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

92,395

 

 

 

73,406

 

 

 

226,332

 

 

 

145,039

 

Research and development

 

9,969

 

 

 

7,130

 

 

 

20,247

 

 

 

14,372

 

Total operating expenses

 

102,364

 

 

 

80,536

 

 

 

246,579

 

 

 

159,411

 

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:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

$

0.01

 

 

$

(0.01

)

 

$

(0.04

)

 

$

(0.08

)

Diluted

$

0.01

 

 

$

(0.01

)

 

$

(0.04

)

 

$

(0.08

)

Weighted average shares:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

384,663

 

 

 

330,863

 

 

 

373,300

 

 

 

329,793

 

Diluted

 

399,664

 

 

 

330,863

 

 

 

373,300

 

 

 

329,793

 

 

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

 

 

 

 

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

 

 

 

(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

 

 

See notes to condensed consolidated financial statements.

   5


AMARIN CORPORATION PLC

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited, in thousands)

 

 

 

 

Six months ended June 30,

 

 

 

2020

 

 

2019

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

 

 

 

Net loss

 

$

(16,138

)

 

$

(26,251

)

Adjustments to reconcile loss to net cash provided by (used in) operating activities:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

296

 

 

 

6

 

Amortization of investments

 

 

33

 

 

 

 

Stock-based compensation

 

 

22,722

 

 

 

14,766

 

Amortization of debt discount and debt issuance costs

 

 

490

 

 

 

878

 

Amortization of intangible asset

 

 

720

 

 

 

323

 

Changes in assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable, net

 

 

(8,555

)

 

 

(28,875

)

Inventory

 

 

(48,075

)

 

 

11,534

 

Prepaid and other current assets

 

 

(10,273

)

 

 

(4,158

)

Other long-term assets