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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, 2022

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.)

 

Iconic Offices, The Greenway, Block C Ardilaun Court,

112 – 114 St Stephens Green

 

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

403,828,955 common shares were outstanding as of October 21, 2022, including 383,347,128 shares held as American Depositary Shares (ADSs), each representing one Ordinary Share, 50 pence par value per share and 20,481,827 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, 2022 and December 31, 2021

 

3

 

 

Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2022 and 2021

 

4

 

 

Condensed Consolidated Statement of Changes in Stockholders’ Equity for the nine months ended September 30, 2022 and 2021

 

5

 

 

Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2022 and 2021

 

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

 

38

Item 4.

 

Controls and Procedures

 

38

 

 

 

PART II – Other Information

 

 

 

Item 1.

 

Legal Proceedings

 

39

Item 1A.

 

Risk Factors

 

39

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

 

82

Item 5.

 

Other Information

 

82

Item 6.

 

Exhibits

 

83

 

SIGNATURES

 

84

 

 

2


 

PART I

AMARIN CORPORATION PLC

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited, in thousands, except share amounts)

 

 

 

 

September 30, 2022

 

 

December 31, 2021

 

ASSETS

 

 

 

 

 

 

Current Assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

240,498

 

 

$

219,454

 

Restricted cash

 

 

3,920

 

 

 

3,918

 

Short-term investments

 

 

63,203

 

 

 

234,674

 

Accounts receivable, net

 

 

123,379

 

 

 

163,653

 

Inventory

 

 

227,606

 

 

 

234,676

 

Prepaid and other current assets

 

 

27,914

 

 

 

22,352

 

Total current assets

 

 

686,520

 

 

 

878,727

 

Property, plant and equipment, net

 

 

999

 

 

 

1,425

 

Long-term investments

 

 

2,264

 

 

 

34,996

 

Long-term inventory

 

 

187,964

 

 

 

121,254

 

Operating lease right-of-use asset

 

 

8,462

 

 

 

7,660

 

Other long-term assets

 

 

456

 

 

 

456

 

Intangible asset, net

 

 

21,638

 

 

 

23,547

 

TOTAL ASSETS

 

$

908,303

 

 

$

1,068,065

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

 

Accounts payable

 

$

93,157

 

 

$

114,922

 

Accrued expenses and other current liabilities

 

 

192,001

 

 

 

253,111

 

Current deferred revenue

 

 

2,198

 

 

 

2,649

 

Total current liabilities

 

 

287,356

 

 

 

370,682

 

Long-Term Liabilities:

 

 

 

 

 

 

Long-term deferred revenue

 

 

13,499

 

 

 

14,060

 

Long-term operating lease liability

 

 

9,924

 

 

 

8,576

 

Other long-term liabilities

 

 

9,697

 

 

 

7,648

 

Total liabilities

 

 

320,476

 

 

 

400,966

 

Commitments and contingencies (Note 5)

 

 

 

 

 

 

Stockholders’ Equity:

 

 

 

 

 

 

Common stock, £0.50 par, unlimited authorized; 411,660,040 shares issued, 403,828,955 shares outstanding as of September 30, 2022; 404,084,775 shares issued, 396,598,008 shares outstanding as of December 31, 2021

 

 

298,596

 

 

 

294,027

 

Additional paid-in capital

 

 

1,878,923

 

 

 

1,855,246

 

Treasury stock; 7,831,085 shares as of September 30, 2022; 7,486,767 shares as of December 31, 2021

 

 

(61,585

)

 

 

(60,726

)

Accumulated deficit

 

 

(1,528,107

)

 

 

(1,421,448

)

Total stockholders’ equity

 

 

587,827

 

 

 

667,099

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

908,303

 

 

$

1,068,065

 

 

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,

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Product revenue, net

$

89,222

 

 

$

141,442

 

 

$

277,004

 

 

$

436,598

 

Licensing and royalty revenue

 

656

 

 

 

596

 

 

 

1,944

 

 

 

2,098

 

Total revenue, net

 

89,878

 

 

 

142,038

 

 

 

278,948

 

 

 

438,696

 

Less: Cost of goods sold

 

23,941

 

 

 

30,211

 

 

 

81,990

 

 

 

90,692

 

Less: Cost of goods sold - restructuring inventory

 

3,078

 

 

 

 

 

 

18,078

 

 

 

 

Gross margin

 

62,859

 

 

 

111,827

 

 

 

178,880

 

 

 

348,004

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

58,745

 

 

 

102,965

 

 

 

236,285

 

 

 

315,966

 

Research and development

 

5,765

 

 

 

7,820

 

 

 

25,172

 

 

 

23,554

 

Restructuring

 

3,493

 

 

 

14,115

 

 

 

13,706

 

 

 

14,115

 

Total operating expenses

 

68,003

 

 

 

124,900

 

 

 

275,163

 

 

 

353,635

 

Operating loss

 

(5,144

)

 

 

(13,073

)

 

 

(96,283

)

 

 

(5,631

)

Interest income, net

 

750

 

 

 

163

 

 

 

1,241

 

 

 

919

 

Other income (expense), net

 

511

 

 

 

(57

)

 

 

(1,990

)

 

 

(390

)

Loss from operations before taxes

 

(3,883

)

 

 

(12,967

)

 

 

(97,032

)

 

 

(5,102

)

Income tax provision

 

(1,257

)

 

 

(184

)

 

 

(9,627

)

 

 

(1,867

)

Net loss

$

(5,140

)

 

$

(13,151

)

 

$

(106,659

)

 

$

(6,969

)

Loss per share:

 

 

 

 

 

 

 

 

 

 

 

Basic

$

(0.01

)

 

$

(0.03

)

 

$

(0.27

)

 

$

(0.02

)

Diluted

$

(0.01

)

 

$

(0.03

)

 

$

(0.27

)

 

$

(0.02

)

Weighted average shares:

 

 

 

 

 

 

 

 

 

 

 

Basic

 

404,614

 

 

 

396,618

 

 

 

399,944

 

 

 

395,681

 

Diluted

 

404,614

 

 

 

396,618

 

 

 

399,944

 

 

 

395,681

 

 

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)

 

 

 

Common
Shares

 

 

Treasury
Shares

 

 

Common
Stock

 

 

Additional
Paid-in
Capital

 

 

Treasury
Stock

 

 

Accumulated
Deficit

 

 

Total

 

December 31, 2021

 

 

404,084,775

 

 

 

(7,486,767

)

 

$

294,027

 

 

$

1,855,246

 

 

$

(60,726

)

 

$

(1,421,448

)

 

$

667,099

 

Exercise of stock options

 

 

10,602

 

 

 

 

 

 

6

 

 

 

24

 

 

 

 

 

 

 

 

 

30

 

Vesting of restricted stock units

 

 

493,381

 

 

 

(161,083

)

 

 

331

 

 

 

(331

)

 

 

(535

)

 

 

 

 

 

(535

)

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

6,078

 

 

 

 

 

 

 

 

 

6,078

 

Loss for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(31,563

)

 

 

(31,563

)

March 31, 2022

 

 

404,588,758

 

 

 

(7,647,850

)

 

$

294,364

 

 

$

1,861,017

 

 

$

(61,261

)

 

$

(1,453,011

)

 

$

641,109

 

Issuance of common stock under employee stock purchase plan

 

 

265,214

 

 

 

 

 

 

166

 

 

 

217

 

 

 

 

 

 

 

 

 

383

 

Exercise of stock options

 

 

14,645

 

 

 

 

 

 

9

 

 

 

10

 

 

 

 

 

 

 

 

 

19

 

Vesting of restricted stock units

 

 

187,835

 

 

 

(61,551

)

 

 

120

 

 

 

(120

)

 

 

(158

)

 

 

 

 

 

(158

)

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

8,646

 

 

 

 

 

 

 

 

 

8,646

 

Loss for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(69,956

)

 

 

(69,956

)

June 30, 2022

 

 

405,056,452

 

 

 

(7,709,401

)

 

$

294,659

 

 

$

1,869,770

 

 

$

(61,419

)

 

$

(1,522,967

)

 

$

580,043

 

Issuance of common stock for milestone payment

 

 

5,817,942

 

 

 

 

 

 

3,461

 

 

 

4,742

 

 

 

 

 

 

 

 

 

8,203

 

Exercise of stock options

 

 

8,056

 

 

 

 

 

 

5

 

 

 

5

 

 

 

 

 

 

 

 

 

10

 

Vesting of restricted stock units

 

 

777,590

 

 

 

(121,684

)

 

 

471

 

 

 

(471

)

 

 

(166

)

 

 

 

 

 

(166

)

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

4,877

 

 

 

 

 

 

 

 

 

4,877

 

Loss for the period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(5,140

)

 

 

(5,140

)

September 30, 2022

 

 

411,660,040

 

 

 

(7,831,085

)

 

$

298,596

 

 

$

1,878,923

 

 

$

(61,585

)

 

$

(1,528,107

)

 

$

587,827

 

 

 

 

Common
Shares

 

 

Treasury
Shares

 

 

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

)