Investor Relations / Node / 10-Q / 10-Q

amrn-10q_20190630.htm
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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, 2019

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

 

2 Pembroke House, Upper Pembroke Street 28-32, Dublin 2, Ireland

Former name or former address, if changed since last report

 

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  

357,214,478 common shares were outstanding as of July 29, 2019, including 357,009,987 shares held as American Depositary Shares (ADSs), each representing one Ordinary Share, 50 pence par value per share and 204,491 Ordinary Shares. In addition, 28,931,746 ordinary share equivalents were issuable in exchange for outstanding preferred shares as of July 29, 2019, for a total of 386,146,224 ordinary shares and ordinary share equivalents outstanding as of July 29, 2019.

 


INDEX TO FORM 10-Q

 

 

 

 

 

Page

 

 

 

PART I – Financial Information

 

 

 

Item 1.

 

Financial Statements (unaudited):

 

 

 

 

Condensed Consolidated Balance Sheets as of June 30, 2019 and December 31, 2018

 

3

 

 

Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2019 and 2018

 

4

 

 

Condensed Consolidated Statement of Changes in Stockholders’ Equity (Deficit) for the six months ended June 30, 2019 and 2018

 

5

 

 

Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2019 and 2018

 

6

 

 

Notes to Condensed Consolidated Financial Statements

 

7

Item 2.

 

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

 

24

Item 3.

 

Quantitative and Qualitative Disclosures about Market Risk

 

35

Item 4.

 

Controls and Procedures

 

35

 

 

 

PART II – Other Information

 

 

 

Item 1.

 

Legal Proceedings

 

36

Item 1A.

 

Risk Factors

 

36

 

 

 

 

 

Item 6.

 

Exhibits

 

76

 

SIGNATURES

 

77

 

2


PART I

AMARIN CORPORATION PLC

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited, in thousands, except share amounts)

 

 

 

June 30, 2019

 

 

December 31, 2018

 

ASSETS

 

 

 

 

 

 

 

 

Current Assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

221,771

 

 

$

249,227

 

Restricted cash

 

 

1,503

 

 

 

1,500

 

Accounts receivable, net

 

 

95,398

 

 

 

66,523

 

Inventory

 

 

46,268

 

 

 

57,802

 

Prepaid and other current assets

 

 

7,103

 

 

 

2,945

 

Total current assets

 

 

372,043

 

 

 

377,997

 

Property, plant and equipment, net

 

 

858

 

 

 

63

 

Operating lease right-of-use asset

 

 

8,762

 

 

 

 

Other long-term assets

 

 

1,102

 

 

 

174

 

Intangible asset, net

 

 

7,157

 

 

 

7,480

 

TOTAL ASSETS

 

$

389,922

 

 

$

385,714

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

34,018

 

 

$

37,632

 

Accrued expenses and other current liabilities

 

 

103,495

 

 

 

84,171

 

Current portion of long-term debt from royalty-bearing instrument

 

 

45,410

 

 

 

34,240

 

Deferred revenue, current

 

 

1,962

 

 

 

1,220

 

Total current liabilities

 

 

184,885

 

 

 

157,263

 

Long-Term Liabilities:

 

 

 

 

 

 

 

 

Long-term debt from royalty-bearing instrument

 

 

23,202

 

 

 

46,108

 

Deferred revenue, long-term

 

 

17,775

 

 

 

19,490

 

Long-term operating lease liability

 

 

8,160

 

 

 

 

Other long-term liabilities

 

 

6,813

 

 

 

10,523

 

Total liabilities

 

 

240,835

 

 

 

233,384

 

Commitments and contingencies (Note 6)

 

 

 

 

 

 

 

 

Stockholders’ Equity:

 

 

 

 

 

 

 

 

Series A Convertible Preferred Stock, £0.05 par, unlimited authorized; 289,317,460 shares issued and outstanding as of June 30, 2019 and December 31, 2018 (equivalent to 28,931,746 ordinary shares upon future consolidation and redesignation at a 10:1 ratio)

 

 

21,850

 

 

 

21,850

 

Common stock, £0.50 par, unlimited authorized; 335,149,425 issued, 331,307,810 outstanding as of June 30, 2019; 329,110,863 issued, 325,850,013 outstanding as of December 31, 2018

 

 

250,588

 

 

 

246,663

 

Additional paid-in capital

 

 

1,311,965

 

 

 

1,282,762

 

Treasury stock; 3,841,615 shares as of June 30, 2019; 3,260,850 shares as of December 31, 2018

 

 

(20,533

)

 

 

(10,413

)

Accumulated deficit

 

 

(1,414,783

)

 

 

(1,388,532

)

Total stockholders’ equity

 

 

149,087

 

 

 

152,330

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

389,922

 

 

$

385,714

 

 

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,

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Product revenue, net

$

100,366

 

 

$

52,537

 

 

$

173,097

 

 

$

96,313

 

Licensing revenue

 

426

 

 

 

106

 

 

 

973

 

 

 

248

 

Total revenue, net

 

100,792

 

 

 

52,643

 

 

 

174,070

 

 

 

96,561

 

Less: Cost of goods sold

 

22,770

 

 

 

12,846

 

 

 

39,910

 

 

 

23,494

 

Gross margin

 

78,022

 

 

 

39,797

 

 

 

134,160

 

 

 

73,067

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

73,406

 

 

 

53,944

 

 

 

145,039

 

 

 

97,350

 

Research and development

 

7,130

 

 

 

18,159

 

 

 

14,372

 

 

 

29,921

 

Total operating expenses

 

80,536

 

 

 

72,103

 

 

 

159,411

 

 

 

127,271

 

Operating loss

 

(2,514

)

 

 

(32,306

)

 

 

(25,251

)

 

 

(54,204

)

Interest income (expense), net

 

789

 

 

 

(1,773

)

 

 

(908

)

 

 

(4,025

)

Other expense, net

 

(95

)

 

 

(131

)

 

 

(92

)

 

 

(76

)

Loss from operations before taxes

 

(1,820

)

 

 

(34,210

)

 

 

(26,251

)

 

 

(58,305

)

(Provision for) benefit from income taxes

 

 

 

 

 

 

 

 

 

 

 

Net loss

$

(1,820

)

 

$

(34,210

)

 

$

(26,251

)

 

$

(58,305

)

Loss per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

$

(0.01

)

 

$

(0.12

)

 

$

(0.08

)

 

$

(0.20

)

Diluted

$

(0.01

)

 

$

(0.12

)

 

$

(0.08

)

 

$

(0.20

)

Weighted average shares:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

330,863

 

 

 

293,662

 

 

 

329,793

 

 

 

289,458

 

Diluted

 

330,863

 

 

 

293,662

 

 

 

329,793

 

 

 

289,458

 

 

See notes to condensed consolidated financial statements.

4


AMARIN CORPORATION PLC

CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)

(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

 

Loss for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(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

 

Loss for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(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

 

 

 

 

Preferred

Shares

 

 

Common

Shares

 

 

Treasury

Shares

 

 

Preferred

Stock

 

 

Common

Stock

 

 

Additional

Paid-in

Capital

 

 

Treasury

Stock

 

 

Accumulated

Deficit

 

 

Total

 

December 31, 2017

 

 

328,184,640

 

 

 

272,719,044

 

 

 

(1,697,033

)

 

$

24,364

 

 

$

208,768

 

 

$

977,866

 

 

$

(4,229

)

 

$

(1,271,869

)

 

$

(65,100

)

Cumulative-effect

   adjustment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(218

)

 

 

(218

)

January 1, 2018

 

 

328,184,640

 

 

 

272,719,044

 

 

 

(1,697,033

)

 

$

24,364

 

 

$

208,768

 

 

$

977,866

 

 

$

(4,229

)

 

$

(1,272,087

)

 

$

(65,318

)

Issuance of common stock,

   net of transaction costs

 

 

 

 

 

20,616,438

 

 

 

 

 

 

 

 

 

14,635

 

 

 

55,372

 

 

 

 

 

 

 

 

 

70,007

 

Exercise of stock options

 

 

 

 

 

782,553

 

 

 

 

 

 

 

 

 

541

 

 

 

1,007

 

 

 

 

 

 

 

 

 

1,548

 

Vesting of restricted stock

   units

 

 

 

 

 

1,838,380

 

 

 

(675,242

)

 

 

 

 

 

1,302

 

 

 

(1,302

)

 

 

(2,553

)

 

 

 

 

 

(2,553

)

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,754

 

 

 

 

 

 

 

 

 

3,754

 

Loss for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(24,095

)

 

 

(24,095

)

March 31, 2018

 

 

328,184,640

 

 

 

295,956,415

 

 

 

(2,372,275

)

 

$

24,364

 

 

$

225,246

 

 

$

1,036,697

 

 

$

(6,782

)

 

$

(1,296,182

)

 

$

(16,657

)

Issuance of common stock

   under employee stock

   purchase plan

 

 

 

 

 

127,872

 

 

 

 

 

 

 

 

 

85

 

 

 

338

 

 

 

 

 

 

 

 

 

423

 

Exercise of stock options

 

 

 

 

 

173,679

 

 

 

 

 

 

 

 

 

116

 

 

 

162

 

 

 

 

 

 

 

 

 

278

 

Vesting of restricted stock

   units

 

 

 

 

 

90,937

 

 

 

(41,252

)

 

 

 

 

 

60

 

 

 

(60

)

 

 

(127

)

 

 

 

 

 

(127

)

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,606

 

 

 

 

 

 

 

 

 

3,606

 

Loss for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(34,210

)

 

 

(34,210

)

June 30, 2018

 

 

328,184,640

 

 

 

296,348,903

 

 

 

(2,413,527

)

 

$

24,364

 

 

$

225,507

 

 

$

1,040,743

 

 

$

(6,909

)

 

$

(1,330,392

)

 

$

(46,687

)

 

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,

 

 

 

2019

 

 

2018

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

 

 

 

Net loss

 

$

(26,251

)

 

$

(58,305

)

Adjustments to reconcile loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

6

 

 

 

11

 

Stock-based compensation

 

 

14,766

 

 

 

7,381

 

Amortization of debt discount and debt issuance costs

 

 

878

 

 

 

1,140

 

Amortization of intangible asset

 

 

323