Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 10-Q

 

 

 

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

For the quarterly period ended September 30, 2011

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. 0-21392

 

 

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.)

 

2 Pembroke House, Upper Pembroke Street 28-32   Dublin 2, Ireland
(Address of Principal Executive Offices)   (Zip Code)

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

 

 

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   x     NO   ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§229.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    YES   x     NO   ¨

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

 

Large accelerated filer   ¨    Accelerated filer   x
Non-accelerated filer   ¨   (Do not check if smaller reporting company)    Smaller reporting company   ¨

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

135,502,062 shares held as American Depository Shares (ADS), each representing one Ordinary Share, 50 pence par value per share, and 315,480 ordinary shares, were outstanding as of November 3, 2011.

 

 

 


Table of Contents

INDEX TO FORM 10-Q

 

         Page  
  PART I – Financial Information   
Item 1.  

Financial Statements:

  
 

Condensed Consolidated Balance Sheets at September 30, 2011 and December 31, 2010

     1   
 

Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) for the three and nine months ended September 30, 2011 and 2010

     2   
 

Condensed Consolidated Statement of Changes in Stockholders’ Deficit at September 30, 2011 and 2010

     3   
 

Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2011 and 2010

     4   
 

Notes to Condensed Consolidated Financial Statements

     5   
Item 2.  

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

     10   
Item 3.  

Quantitative and Qualitative Disclosures about Market Risk

     17   
Item 4.  

Controls and Procedures

     17   
  PART II – Other Information   
Item 1.  

Legal Proceedings

     18   
Item 1A.  

Risk Factors

     18   
Item 6.  

Exhibits

     21   
SIGNATURES      22   


Table of Contents

PART I – FINANCIAL INFORMATION

 

Item 1. Financial Statements

A MARIN C ORPORATION PLC

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share amounts)

 

     September 30,
2011
    December 31,
2010
 
ASSETS     

Current Assets:

    

Cash and cash equivalents

   $ 125,855      $ 31,442   

Other current assets

     2,214        1,671   
  

 

 

   

 

 

 

Total current assets

     128,069        33,113   
  

 

 

   

 

 

 

Property, plant and equipment, net

     73        88   

Other non-current assets

     3,528        2,166   
  

 

 

   

 

 

 

TOTAL ASSETS

   $ 131,670      $ 35,367   
  

 

 

   

 

 

 
LIABILITIES AND STOCKHOLDERS’ DEFICIT     

Current Liabilities:

    

Accounts payable

   $ 3,836      $ 4,449   

Accrued expenses and other liabilities

     2,592        3,128   
  

 

 

   

 

 

 

Total current liabilities

     6,428        7,577   
  

 

 

   

 

 

 

Long-Term Liabilities:

    

Warrant derivative liability

     155,018        230,069   

Lease obligations and other long-term liabilities

     559        88   
  

 

 

   

 

 

 

Total liabilities

     162,005        237,734   
  

 

 

   

 

 

 

Commitments and contingencies (Note 4)

    

Stockholders’ Deficit:

    

Common stock, £0.50 par, unlimited authorized; 135,780,817 issued, 135,760,738 outstanding at September 30, 2011; 106,856,731 issued, 106,836,652 outstanding at December 31, 2010

     113,280        90,465   

Additional paid-in capital

     443,399        206,718   

Treasury stock; 20,079 shares at September 30, 2011 and December 31, 2010

     (217     (217

Accumulated deficit

     (586,797     (499,333
  

 

 

   

 

 

 

Total stockholders’ deficit

     (30,335     (202,367
  

 

 

   

 

 

 

TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT

   $ 131,670      $ 35,367   
  

 

 

   

 

 

 

See notes to condensed consolidated financial statements.

 

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A MARIN C ORPORATION PLC

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)

(In thousands, except per share amounts)

 

     Three months ended
September 30,
    Nine months ended
September 30,
 
     2011     2010     2011     2010  

Revenues

   $ —        $ —        $ —        $ —     

Operating Expenses:

        

Research and development

     6,013        7,642        15,651        20,565   

Marketing, general and administrative

     3,433        2,134        16,185        7,205   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     9,446        9,776        31,836        27,770   
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating loss

     (9,446     (9,776     (31,836     (27,770

Gain (loss) on change in fair value of derivative liability

     106,614        (1,370     (53,403     (33,402

Interest income, net

     3        30        97        15   

Other (expense) income, net

     (59     15        30        (478
  

 

 

   

 

 

   

 

 

   

 

 

 

Income (loss) from operations before taxes

     97,112        (11,101     (85,112     (61,635

Provision for income taxes

     (767     (108     (2,352     (142
  

 

 

   

 

 

   

 

 

   

 

 

 

Net and comprehensive income (loss)

   $ 96,345      $ (11,209   $ (87,464   $ (61,777
  

 

 

   

 

 

   

 

 

   

 

 

 

Income (loss) per share:

        

Basic

   $ 0.72      $ (0.11   $ (0.68   $ (0.62

Diluted

   $ 0.62      $ (0.11   $ (0.68   $ (0.62

Weighted average shares:

        

Basic

     133,238        100,150        128,377        99,284   

Diluted

     155,975        100,150        128,377        99,284   

See notes to condensed consolidated financial statements.

 

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A MARIN C ORPORATION PLC

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIT

(In thousands, except share amounts)

 

     Common
Shares
     Common
Stock
     Additional
Paid-in
Capital
     Treasury
shares
    Retained
earnings
    Total  

At January 1, 2011

     106,856,731       $ 90,465       $ 206,718       $ (217   $ (499,333   $ (202,367

Warrants exercised

     12,855,642         10,263         8,398         —          —          18,661   

Transfer of fair value of warrants exercised from liabilities to equity

     —           —           129,458         —          —          129,458   

Stock issued in January financing

     13,800,000         10,723         87,931         —          —          98,654   

Stock options exercised

     2,255,721         1,819         3,254         —          —          5,073   

Tax benefits from stock-based compensation

     —           —           1,571         —          —          1,571   

Stock issued for services

     12,723         10         47         —          —          57   

Stock-based compensation

     —           —           6,022         —          —          6,022   

Loss for the period

     —           —           —           —          (87,464     (87,464
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

At September 30, 2011

     135,780,817       $ 113,280       $ 443,399       $ (217   $ (586,797   $ (30,335
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

 

     Common
Shares
     Common
Stock
     Additional
Paid-in
Capital
     Treasury
shares
    Retained
earnings
    Total  

At January 1, 2010

     98,801,982       $   84,219       $ 172,339       $ (217   $ (249,744   $ 6,597   

Warrants exercised

     2,507,674         1,898         1,669         —          —          3,567   

Transfer of fair value of warrants exercised from liabilities to equity

     —           —           4,637         —          —          4,637   

Stock options exercised

     31,666         24         5             29   

Stock-based compensation

     —           —           2,010         —          —          2,010   

Loss for the period

     —           —           —           —          (61,777     (61,777
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

At September 30, 2010

     101,341,322       $ 86,141       $ 180,660       $ (217   $ (311,521   $   (44,937
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

See notes to condensed consolidated financial statements.

 

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A MARIN C ORPORATION PLC

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

 

     Nine Months Ended
September 30,
 
     2011     2010  

CASH FLOWS FROM OPERATING ACTIVITIES:

    

Net loss

   $ (87,464   $ (61,777

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

    

Depreciation and amortization

     48        49   

Expense for commitment fee

     1,000        —     

Stock-based compensation

     6,022        2,010   

Stock-based compensation—warrants

     1,004        858   

Stock issued for services

     57        —     

Excess tax benefit from stock-based awards

     (1,571     —     

Loss on changes in fair value of derivative liability

     53,403        33,402   

Changes in assets and liabilities:

    

Other assets

     (1,255     1,253   

Change in lease liability

     (39     (537

Accounts payable, accrued expenses, and other liabilities

     932        404   
  

 

 

   

 

 

 

Net cash used in operating activities

     (27,863     (24,338
  

 

 

   

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES:

    

Purchase of long term investment

     (1,650     —     

Purchases of equipment

     (33     (24
  

 

 

   

 

 

 

Net cash used in investing activities

     (1,683     (24
  

 

 

   

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES:

    

Proceeds from issuance of common stock, net of transaction costs

     98,654        —     

Proceeds from exercise of stock options, net of transaction costs

     5,073        29   

Proceeds from exercise of warrants, net of transaction costs

     18,661        3,567   

Excess tax benefit from stock-based awards

     1,571        —     

Payments under capital leases

     —          (9
  

 

 

   

 

 

 

Net cash provided by financing activities

     123,959        3,587   

NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

     94,413        (20,775

CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD

     31,442        52,258   
  

 

 

   

 

 

 

CASH AND CASH EQUIVALENTS, END OF PERIOD

   $ 125,855      $ 31,483   
  

 

 

   

 

 

 

Supplemental disclosure of cash flow information:

    

Cash paid during the year for:

    

Interest

   $ —        $ —     
  

 

 

   

 

 

 

Income taxes

   $ 581      $ 65   
  

 

 

   

 

 

 

Non-cash transactions:

    

Transfer from derivative liability to equity, fair value of warrants exercised

   $ 129,458      $ 4,637   
  

 

 

   

 

 

 

See notes to condensed consolidated financial statements.

 

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A MARIN C ORPORATION PLC

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

For purposes of this Quarterly Report on Form 10-Q, our ordinary shares may also be referred to as “common shares” or “common stock.”

 

(1) Nature of Business and Basis of Presentation

Nature of Business

Amarin Corporation plc, “Amarin” or the “Company”, is a public limited company with its primary stock market listing in the United States on the NASDAQ Capital Market (AMRN). Amarin was originally incorporated in England as a private limited company on March 1, 1989 under the Companies Act 1985, and re-registered in England as a public limited company on March 19, 1993.

Amarin is a clinical-stage biopharmaceutical company focused on developing improved treatments for cardiovascular disease. The Company is currently focusing its efforts on AMR101 (icosapent ethyl), a prescription-only omega-3 fatty acid, comprising not less than 96% ultra pure icosapent ethyl (ethyl-EPA).

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements of the Company and subsidiaries are unaudited and have been prepared on a basis that assumes that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) have been condensed or omitted pursuant to the rules and regulations of the U.S. Securities and Exchange Commission. These financial statements should be read in conjunction with the audited financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2010. The Company’s current focus is on the development and commercialization of AMR101, which is still under development and not available for sale. However, the Company is not considered a development stage business, as the release and sale of the previous product represented the exit of the Company from the development stage.

The notes and accompanying condensed consolidated financial statements are unaudited. The information furnished reflects all adjustments, which, in the opinion of management, are necessary for a fair presentation of results for the interim periods. Such adjustments consisted only of normal recurring items. The interim periods are not necessarily indicative of the results expected for the full year or any future period.

The preparation of these condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of net sales and expenses during the reporting period. Actual results could differ from those estimates.

At September 30, 2011, the Company had cash and cash equivalents of $125.9 million. The Company’s consolidated balance sheet also includes a significant derivative liability (see footnote 3—warrants and derivative liability) reflecting the fair value of outstanding warrants to purchase shares of the Company’s common stock. This liability can only be settled in shares of the Company’s stock and, as such, would only result in cash inflows upon the exercise of the warrants—not a cash outflow. Accordingly, this warrant derivative liability presents neither a short nor long-term claim on the liquid assets of the Company.

In January 2011, the Company completed an offering of 13.8 million American Depository Shares (ADSs), with each ADS representing one share of the Company’s common stock. The shares were sold at a price of $7.60 per share, and resulted in net proceeds of $98.7 million.

The Company believes its cash will be sufficient to fund its projected operations for the next twelve months which contemplates not only working capital and general corporate needs but also commercial preparation of AMR101 and the initiation of a clinical outcomes study. This is based on management’s current operational plans and does not assume any cash inflows from strategic collaborations, warrant exercises or from equity or debt financings which may occur in future periods.

Unless the Company enters into a strategic collaboration to provide additional capital in connection with the launch, marketing and sale of AMR101, the Company will need to raise additional funds on its own to support these efforts. Additional financing may not be available when the Company needs it or may not be available on terms that are favorable to it. If adequate funds are not available to the Company on a timely basis, or at all, the Company may be required to delay the establishment of sales and marketing capabilities or terminate or delay the clinical outcomes study.

 

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(2) Significant Accounting Policies

Cash and Cash Equivalents

Cash and cash equivalents consist of cash, deposits held at call with banks, and short term highly liquid instruments with remaining maturities at the date of purchase of 90 days or less.

Research and Development Costs

The Company charges research and development costs to operations as incurred. Research and development expenses are comprised of costs incurred by the Company in performing research and development activities, including salary and benefits; stock-based compensation expense; laboratory supplies and other direct expenses; contractual services, including clinical trial and pharmaceutical development costs; commercial supply investment in its drug candidates; and infrastructure costs, including facilities costs and depreciation expense.

Marketing, General and Administrative Costs

Warrant related expense from non-cash changes in fair value of the warrant derivative liability associated with warrants issued in October 2009 to former employees of Amarin is recorded as compensation expense and classified as part of marketing, general and administrative costs, net of warrants exercised.

Income Taxes

Deferred tax assets and liabilities are recognized for the future tax consequences of differences between the carrying amounts and tax bases of assets and liabilities and operating loss carryforwards and other attributes using enacted rates expected to be in effect when those differences reverse. Valuation allowances are provided against deferred tax assets that are not more likely than not to be realized.

The Company provides reserves for potential payments of tax to various tax authorities or does not recognize tax benefits related to uncertain tax positions and other issues. Tax benefits for uncertain tax positions are based on a determination of whether a tax benefit taken by the Company in its tax filings or positions is “more likely than not” to be realized, assuming that the matter in question will be decided based on its technical merits. The Company’s policy is to record interest and penalties in the provision for income taxes.

Net Income (Loss) per Share

Basic net income (loss) per share is determined by dividing net income (loss) by the weighted average shares of common stock outstanding during the period. Diluted net income (loss) per share is determined by dividing net income (loss) by diluted weighted average shares outstanding. Diluted weighted average shares reflects the dilutive effect, if any, of potentially dilutive common shares, such as common stock options and warrants calculated using the treasury stock method and convertible notes using the “if-converted” method. In periods with reported net operating losses, all common stock options and warrants are deemed anti dilutive such that basic net loss per share and diluted net loss per share are equal.

The following table presents the calculation of both basic and diluted net income (loss) per share:

 

     Three months ended
September 30,
    Nine months ended
September 30,
 
     2011      2010     2011     2010  

Net income (loss)

   $ 96,345       $ (11,209   $ (87,464   $ (61,777
  

 

 

    

 

 

   

 

 

   

 

 

 

Weighted average shares outstanding

     133,238         100,150        128,377        99,284   

Dilutive effect of employee stock options and warrants

     22,737         0        0        0   
  

 

 

    

 

 

   

 

 

   

 

 

 

Diluted weighted average shares outstanding

     155,975         100,150        128,377        99,284   
  

 

 

    

 

 

   

 

 

   

 

 

 

Basic income (loss) per share

   $ 0.72       $ (0.11   $ (0.68   $ (0.62

Diluted income (loss) per share

   $ 0.62       $ (0.11   $ (0.68   $ (0.62

Potentially dilutive securities representing approximately 3.2 million and 51.0 million shares of common stock for the three month periods ended September 30, 2011 and September 30, 2010, respectively, and approximately 31.9 million and 51.0 million shares of common stock for the nine months ended September 30, 2011 and September 30, 2010, respectively were excluded from the computation of diluted earnings per share for these periods because their effect would have been anti-dilutive.

 

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Stock-Based Compensation

Stock-based compensation cost is measured at the grant date, based on the fair value of the award, and is recognized as compensation cost over the requisite service period.

Derivative Instruments

Derivative financial liabilities are recorded at fair value, with gains and losses arising for changes in fair value recognized in the statement of operations at each period end while such instruments are outstanding. If the Company issues shares to discharge the liability, the derivative financial liability is derecognized and common stock and additional paid-in capital are recognized on the issuance of those shares. The warrants are valued using a Black-Scholes option pricing model or a Monte Carlo simulation depending on the nature of instrument.

If the terms of warrants that initially require the warrants to be classified as derivative financial liabilities lapse, the derivative financial liability is reclassified out of financial liabilities into equity at its fair value on that date. At settlement date, if the instruments are settled in shares the carrying value of the warrants are derecognised and transferred to equity at their fair value at that date. The cash proceeds received from exercises of warrants are recorded in common stock and additional paid-in capital.

Foreign Currency

All subsidiaries use the United States dollar as the functional currency. Monetary assets and liabilities denominated in a foreign currency are remeasured into United States dollars at year-end exchange rates. Non-monetary assets and liabilities carried in a foreign currency are remeasured into United States dollars using rates of exchange prevailing when such assets or liabilities were obtained or incurred, and expenses are generally remeasured using rates of exchange prevailing when such expenses are incurred. Gains and losses from the remeasurement are included in other income, net in the consolidated financial statements of operations. For transactions settled during the period, gains and losses are included in other income, net in the consolidated statements of operations. Foreign exchange gains (and losses) have not been significant in the periods presented.

Fair Value of Financial Instruments

The Company provides disclosure of financial assets and financial liabilities that are carried at fair value based on the price that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements may be classified based on the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities using the following three levels:

Level 1—Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.

Level 2—Inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (i.e., interest rates, yield curves, etc.) and inputs that are derived principally from or corroborated by observable market data by correlation or other means (market corroborated inputs).

Level 3—Unobservable inputs that reflect the Company’s estimates of the assumptions that market participants would use in pricing the asset or liability. The Company develops these inputs based on the best information available, including its own data.

The following table presents information about the Company’s liability as of September 30, 2011 and December 31, 2010 that is measured at fair value on a recurring basis and indicates the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value:

 

     September 30, 2011  
In thousands    Total      Level 1      Level 2      Level 3  

Liability:

           

Warrant derivative liability

   $ 155,018       $ —         $ —         $ 155,018   
  

 

 

    

 

 

    

 

 

    

 

 

 

 

     December 31, 2010  
In thousands    Total      Level 1      Level 2      Level 3  

Liability:

           

Warrant derivative liability

   $ 230,069       $ —         $ —         $ 230,069   
  

 

 

    

 

 

    

 

 

    

 

 

 

The carrying amounts of cash, cash equivalents, accounts payable and accrued liabilities approximate fair value because of their short-term nature.

 

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At December 31, 2010, the fair value of the warrant derivative liability was determined to be $230.1 million using the Black-Scholes option valuation model applying the following assumptions: (i) risk-free rate of 1.52%, (ii) remaining term of 3.8 years, (iii) no dividend yield (iv) volatility of 117%, and (v) the stock price on the date of measurement.

At September 30, 2011, the fair value of the warrant derivative liability was determined to be $155.0 million using the Black-Scholes option valuation model applying the following assumptions: (i) risk-free rate of 0.42%, (ii) remaining term of 3.0 years, (iii) no dividend yield, (iv) volatility of 118%, and (v) the stock price on the date of measurement. The $75.1 million decrease in the fair value of the warrant liability during the nine months ended September 30, 2011 was recognized as: (i) a $129.5 million transfer from warrant liability to additional paid-in capital for the fair value of warrants exercised during the nine months ended September 30, 2011, (ii) a $53.4 million loss on the change in fair value of the remaining derivative liability and (iii) $1.0 million in compensation expense for the change in fair value of warrants issued to former employees. The change in the fair value of the warrant derivative liability is as follows (in thousands):

 

     Three months ended
September 30
    Nine months ended
September 30
 

Balance at June 30, 2010 & December 31, 2009

   $ 72,422      $ 41,520   

Loss on change in fair value of derivative liability

     1,370        33,402   

Compensation expense for change in fair value of warrants issued to former employees

     36        858   

Transfers to equity

     (2,685     (4,637
  

 

 

   

 

 

 

Balance at September 30, 2010

   $ 71,143      $ 71,143   
  

 

 

   

 

 

 

 

     Three months ended
September 30
    Nine months ended
September 30
 

Balance at June 30, 2011 & December 31, 2010

   $ 285,984      $ 230,069   

(Gain) loss on change in fair value of derivative liability

     (106,614     53,403   

Compensation (income) expense for change in fair value of warrants issued to former employees

     (3,352     1,004   

Transfers to equity

     (21,000     (129,458
  

 

 

   

 

 

 

Balance at September 30, 2011

   $ 155,018      $ 155,018   
  

 

 

   

 

 

 

Segment and Geographical Information

For the three and nine months ended September 30, 2011 and 2010, the Company has reported its business as a single reporting segment. The Company’s chief decision maker, who is the Chief Executive Officer, regularly evaluates the Company on a consolidated basis.

Recent Accounting Pronouncements

From time to time, new accounting pronouncements are issued by FASB and are adopted by the Company as of the specified effective date. The Company believes that the impact of other recently issued but not yet adopted accounting pronouncements will not have a material impact on consolidated financial position, results of operations, and cash flows, or do not apply to the Company’s operations.

 

(3) Warrants and Derivative Liability

The Company has 21,139,090 warrants to purchase common shares outstanding at September 30, 2011 at a weighted-average exercise price of $1.48, as summarized in the following table:

 

Issue Date      Amount      Exercise Price      Expiration Date  
  4/27/07         17,500         17.90         1/17/2014   
  6/1/07         55,737         7.20         5/31/12   
  12/5/07         539,027         1.17         12/3/12   
  7/31/09         138,888         1.00         7/30/14   
  7/31/09         1,666,000         1.00         7/30/14   
  10/16/09         18,074,888         1.50         10/15/14   
  10/16/09         647,050         1.50         10/15/14   
  

 

 

    

 

 

    
     21,139,090       $ 1.48      
  

 

 

       

October 2009 Warrants

On October 16, 2009, the Company completed a $70.0 million private placement with both existing and new investors resulting in $62.3 million in net proceeds and an additional $3.6 million from bridge notes converted in conjunction with the private placement. In consideration for the $62.3 million in net cash proceeds Amarin issued 66.4 million units, each unit consisting of (i) one ADS (representing one ordinary share) at a purchase price of $1.00 and (ii) a warrant with a five year term to purchase 0.5 of an ADS at an exercise price of $1.50 per ADS. In

 

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consideration for the conversion of $3.6 million of convertible bridge notes, Amarin issued 4.0 million units, each unit consisting of (i) one ADS (representing one ordinary share) at a purchase price of $0.90 and (ii) a warrant with a five year term to purchase 0.5 of an ADS at an exercise price of $1.50 per ADS. The total number of warrants issued in conjunction with the financing was 35.2 million.

The warrants issued in connection with the October 2009 financing contained a pricing variability feature which provided for an increase to the exercise price if the exchange rate between the U.S. dollar and British pound adjusts such that the warrants could be issued at a price less than the £0.5 par value of the common stock – that is, if the exchange rate exceeded U.S. $3.00 per £1.0 sterling. Due to the potential variable nature of the exercise price, the warrants are not considered to be indexed to the Company’s common stock. Accordingly, the warrants do not qualify for the exception to classify the warrants within equity and are classified as a derivative liability. The fair value of this warrant derivative liability is remeasured at each reporting period, with changes in fair value recognized in the statement of operations. The fair value of the warrants at December 31, 2010 was determined to be approximately $230.1 million using the Black-Scholes option pricing model.

Although the warrants contain a pricing variability feature, the number of warrants issuable remains fixed. Therefore, as of September 30, 2011 the maximum number of common shares issuable as a result of the October 2009 private placement is 18.7 million. During the three and nine months ended September 30, 2011, approximately 2.5 million and 12.1 million of the October 2009 warrants were exercised, respectively, resulting in gross proceeds to the Company of approximately $3.8 million and $18.1 million, respectively. During the three and nine months ended September 30, 2010, approximately 1.3 million and 2.2 million warrants were exercised, respectively, resulting in gross proceeds of the Company of approximately $1.9 million and $3.3 million, respectively. Upon exercise, the fair value of the warrants exercised is remeasured and reclassified from warrant liability to additional paid-in capital. During the nine months ended September 30, 2011, $129.5 million of fair value for the exercised warrants was transferred from warrant liability to additional paid in capital, with the change in the fair value on the exercise date recognized in the statement of operations. The fair value of the warrant liability at September 30, 2011 for the remaining warrants was determined to be approximately $155.0 million. The Company recognized a loss on change in fair value of derivative liability of $53.4 million and compensation expense of $1.0 million for the nine month period ended September 30, 2011.

 

(4) Commitments and Contingencies

Litigation

The Company is, from time to time, subject to legal proceedings, claims, and litigation arising in the normal course of business. At September 30, 2011, there were no asserted claims against the Company which, in the opinion of management, would have a material effect on the consolidated financial statements.

Royalty and Milestone Obligations

The Company is party to certain milestone and royalty obligations under several product development agreements, as follows:

 

   

The 2010 supply agreement with the Company’s existing Japan-based supplier: (i) a one-time non-refundable payment of $0.5 million is due to the supplier upon the first marketing approval of AMR101 in the United States (ii) the Company is subject to minimum supply purchase commitments; and (iii) if the Company is not successful in obtaining NDA approval for AMR101, a penalty equal to the facility expansion costs incurred by the supplier to meet the supply demands, not to exceed $5.0 million, less any profits paid to the supplier for purchased materials under the existing agreement;

 

   

The Company signed agreements in the second quarter of 2011 for the supply of materials for AMR101 with two new API suppliers, Equateq and Chemport. These agreements provide access to additional API supply that is incremental to supply from its existing Japan-based API supplier. These agreements include requirements for the suppliers to qualify their materials and facilities. The Company anticipates incurring certain costs associated with the qualification of product produced by these suppliers. Following FDA approvals of AMR101, both agreements include annual purchase levels to enable Amarin to maintain exclusivity with each respective supplier, and to prevent potential termination of the agreements. Because the Company has not yet obtained FDA approval for AMR101, no liability has been recorded. The 2011 supply agreement with Equateq also includes (i) a one-time commitment fee of $1.0 million, (ii) development fees up to a maximum of $0.5 million, and (iii) material commitments of up to $5.0 million for initial raw materials, which will be credited against future API purchases, and is refundable to Amarin if Equateq fails to successfully develop and qualify the API by a certain date. The $1.0 million commitment fee paid to Equateq in May 2011 is refundable if Equateq fails to satisfy certain capital sufficiency requirements. The 2011 supply agreement with Chemport includes, prior to a marketing approval, a raw material purchase commitment of $1.1 million. No payments have been made under this agreement as of September 30, 2011;

 

   

Concurrent with the agreement with Chemport for commercial supply, Amarin agreed to make a minority share equity investment in Chemport of up to $3.3 million. In July 2011, the Company paid to Chemport $1.7 million under this agreement, which has been included in other long term assets at September 30, 2011.

 

   

The 2009 Lorazepam sale agreement with Elan, whereunder Elan did not assume any obligations under a related Neurostat development agreement and, as a result, Amarin retained a potential obligation to make two milestone payments to Neurostat, contingent upon future events: (i) a $0.2 million payment if the drug is administered to human subjects by Elan and (ii) a $0.2 million payment if the drug is tested by Elan in an efficacy study. During the third quarter of 2011, the Company was notified that the first milestone was completed. The milestone payable of $0.2 million has been included in accounts payable at September 30, 2011, and was paid in October 2011.

 

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Under the 2004 share repurchase agreement with Laxdale Limited, in connection with commercialization of AMR101 for cardiovascular indications, prior to the end of 2012 the Company is required to pay potential royalties to a former employee of Laxdale of 1% on net sales up to £100 million (approximately $156 million at September 30, 2011); 0.5% for net sales between £100 million (approximately $156 million at September 30, 2011) and £500 million (approximately $781 million at September 30, 2011); and 0.25% for sales in excess of £500 million (approximately $781 million at September 30, 2011).

 

   

In addition, under this same agreement with Laxdale Limited, upon receipt of marketing approval in the U.S. and/or Europe for the first indication for AMR101 (or first indication of any product containing Amarin Neuroscience intellectual property acquired from Laxdale Limited in 2004), the Company must make an aggregate stock or cash payment to the former shareholders of Laxdale Limited (at the sole option of each of the sellers) of £7.5 million (approximately $11.7 million at September 30, 2011) for each of the two potential marketing approvals (i.e. £15 million maximum, or approximately $23.4 million at September 30, 2011). In addition, upon receipt of a marketing approval in the U.S. or Europe for a further indication of AMR101 (or further indication of any other product using Amarin Neuroscience intellectual property), the Company must make an aggregate stock or cash payment (at the sole option of each of the sellers) of £5 million (approximately $7.8 million at September 30, 2011) for each of the two potential market approvals (i.e. £10 million maximum, or approximately $15.6 million at September 30, 2011).

Other than $0.2 million for the Neurostat milestone payable to Neurostat noted above, the Company has no provision for any of the obligations noted above since the amounts are either not probable or estimable at September 30, 2011.

 

(5) Equity

Common stock

In January 2011, Amarin sold 13.8 million common shares to both existing and new investors at a price of $7.60 per share, resulting in proceeds of $98.7 million, net of $6.2 million in transaction costs.

During the three and nine months ended September 30, 2011, the Company issued 91,074 and 2,255,721 shares, respectively, as a result of the exercise of stock options, resulting in net proceeds of $0.1 million and $5.1 million, respectively. In addition, during the three and nine months ended September 30, 2011, the Company issued 2,525,000 and 12,855,642 shares, respectively, as a result of the exercise of warrants, resulting in net proceeds of $3.7 million and $18.7 million, respectively.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements reflect our plans, estimates and beliefs. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “would” and similar expressions intended to identify forward-looking statements. Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Because of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not transpire. We discuss many of these risks in Part I, Item 1A under the heading “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2010 and below under Part II, Item IA, “Risk Factors”.

Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent our estimates and assumptions only as of the date of this document. You should read this document with the understanding that our actual future results may be materially different from what we expect. Except as required by law, we do not undertake any obligation to publicly update or revise any forward-looking statements contained in this report, whether as a result of new information, future events or otherwise.

Overview

We are a clinical-stage biopharmaceutical company focused on developing improved treatments for cardiovascular disease. We are currently focusing our efforts on AMR101, a semi-synthetic omega-3 fatty acid, comprising not less than 96% ultra pure icosapent ethyl (ethyl-EPA). On October 16, 2009, we completed a private placement resulting in gross proceeds of $70.0 million. These proceeds were used primarily to fund the MARINE and ANCHOR studies for AMR101. In connection with this private placement, a significant portion of our board of directors and executive management were changed, and our research and development activities, as well as certain executive functions, were consolidated in the United States. In connection with these changes, we re-focused our efforts on developing improved treatments for cardiovascular disease and ceased development of all product candidates outside of our cardiovascular disease focus.

In November 2010, we reported positive top-line results from the MARINE trial, the first to complete of our two concurrently run Phase 3 clinical trials of AMR101. In the MARINE trial, AMR101 was investigated as a treatment for patients with very high triglycerides ( ³ 500

 

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mg/dL). The MARINE trial was a multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in 229 patients with fasting triglyceride levels ³ 500 mg/dL. Patients with this level of triglycerides are characterized as having very high triglyceride levels, as outlined in the National Cholesterol Education Program (NCEP) Expert Panel (Adult Treatment Panel III, 2002), or the NCEP Guidelines. The primary endpoint in the trial was the percentage change in triglyceride level from baseline compared to placebo after 12 weeks of treatment. Reported top-line results of this study included announcement that AMR101 met the primary endpoint at both the 4 gram and 2 gram doses. In addition to achieving the primary endpoint of the trial, no statistically significant increase in low-density lipoprotein cholesterol, or LDL-C, was observed in this trial at either dose. Additionally, we observed in the trial a safety profile for AMR101 similar to placebo.

Patients enrolled in the MARINE trial were given the option to be treated with AMR101 for a period of up to 40-weeks after their last dose in the pivotal trial. The results from this 40-week open label non-placebo controlled extension period are not part of the MARINE trial primary endpoints.

In April 2011, we reported positive top-line results from the ANCHOR trial, the second of our two Phase 3 clinical trials of AMR101. In the ANCHOR trial, AMR101 was investigated as a treatment for patients with high triglycerides ( ³ 200 and <500 mg/dL) who are also receiving statin therapy. The ANCHOR trial was a multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in 702 patients with high triglycerides who were on optimized statin therapy. Patients in this trial are characterized as having high triglyceride levels, as outlined in the NCEP Guidelines, with mixed dyslipidemia (two or more lipid disorders). The primary endpoint in the trial was the percentage change in triglyceride level from baseline compared to placebo after 12 weeks of treatment. No prescription omega-3 based drug is currently approved in the U.S. for treating high triglyceride levels in statin-treated patients who have mixed dyslipidemia. Reported top-line results of this study included an announcement that AMR101 met the study’s primary endpoint at both the 4 gram and 2 gram doses. In addition, AMR101 met each of the secondary endpoints in the trial, including at both doses the key secondary endpoint of LDL-C non-inferiority to statin therapy alone. Additionally, we observed in the trial a safety profile for AMR101 similar to placebo.

In addition to achieving the primary endpoints of the MARINE and ANCHOR trials, AMR101, particularly at the 4 gram dose, demonstrated significant reductions in various secondary and exploratory efficacy endpoints for other lipid and inflammate biomarkers which we believe are important as they potentially represent additional predictors of cardiovascular risk. These biomarkers include total cholesterol; non-HDL-cholesterol; VLDL-cholesterol; Apo B (Apolipoprotein B), a sensitive index of residual cardiovascular risk which is generally considered to be a better predictor than LDL-C; Lp-PLA2 (Lipoprotein-phospholipase A2), an enzyme found in blood and atherosclerotic plaque and high levels of which have been implicated in the development and progression of atherosclerosis; and high sensitivity C-reactive protein (hsCRP), an important marker of vascular inflammation.

The MARINE and ANCHOR trials were conducted under separate Special Protocol Assessment, or SPA, with the FDA. An SPA is an evaluation by the FDA of a protocol with the goal of reaching an agreement that the Phase III trial protocol design, clinical endpoints, and statistical analyses are acceptable to support regulatory approval. The FDA agreed that, based on the information we submitted to the agency, the design and planned analysis of the MARINE and ANCHOR trials adequately address the objectives necessary to support a regulatory submission. An SPA is generally binding upon the FDA unless a substantial scientific issue essential to determining safety or efficacy is identified after the testing begins. Although we are not aware of any such issue, there is no assurance that the FDA will ultimately consider either of our SPAs to be binding. Moreover, any change to a study protocol can invalidate an SPA. If the FDA does not consider either of the SPAs to be binding, the agency could assert that additional studies or data are required to support a regulatory submission.

On September 26, 2011 we submitted a New Drug Application (NDA) to the FDA seeking approval to market and sell AMR101 in the United States for the indication studied in the MARINE trial (for the treatment of patients with very high triglycerides). Also included in our NDA submission were the safety and efficacy results of the ANCHOR trial. The FDA has 60 days after receipt of the NDA to preliminarily review the NDA and determine if the application is sufficiently complete to permit a substantive review and if it meets the threshold for filing.

In order to obtain a separate indication for AMR101 based on the ANCHOR trial results, our SPA with the FDA for the ANCHOR trial requires that we have a cardiovascular outcomes study substantially underway at the time of the NDA submission. In accordance with this SPA, the final results of an outcomes study are not required for FDA approval of indication studied in the ANCHOR trial. In accordance with our SPA for the MARINE trial an outcomes study is not required for the indication studied in such trial.

In August 2011, we reached agreement with the FDA on a SPA for the design of the cardiovascular outcomes study of AMR101, titled REDUCE-IT (Reduction of Cardiovascular Events with EPA – Intervention Trial). REDUCE-IT, is a multi-center, prospective, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effectiveness of AMR101 in reducing first major cardiovascular events in an at-risk patient population. The control arm of the study will be patients on optimized statin therapy. The active arm of the study will be patients on optimized statin therapy plus AMR101. All subjects enrolled in the study will have elevated triglyceride levels (fasting TG levels of ³ 135 mg/dL and < 500 mg/dL) and either coronary heart disease or risk factors for coronary heart disease. This study will be conducted internationally. Based on the results of REDUCE-IT, we may seek additional indications for AMR101 beyond the indication studied in the ANCHOR trial such as prevention of cardiac events, although there can be no assurance as to whether the results of the study will support to any such indication. In September 2011 we engaged a clinical research organization to begin initial trial and clinical site preparation. We will seek to have REDUCE-IT at least 50% enrolled by the end of 2012, and project the study to cost between $100 and $125 million over the anticipated six year study period, of which we anticipate not more than $25 million being paid before the end of 2012. We will require additional funds to complete REDUCE-IT.

In accordance with our SPA for the ANCHOR trial, we currently intend to file a supplemental NDA (sNDA) seeking approval of the indication studied in the ANCHOR trial once we have a cardiovascular outcomes study substantially underway. The sNDA cannot be filed until after both

 

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the initially submitted NDA for the indication studied in the MARINE trial is approved and the cardiovascular outcomes study is substantially underway. However, as part of our interaction with the FDA regarding our NDA for the indication studied in the MARINE trial, we may explore whether there is an opportunity for the indication studied in the ANCHOR trial to be considered in conjunction with the FDA’s review of the indication studied in the MARINE trial. However, there can be no assurance that the FDA will approve such an approach.

We have filed and are prosecuting numerous patent applications in the U.S. and internationally. In the U.S. we have filed patent applications which seek to expand to eleven the number of patent families protecting the proprietary position of AMR101. For certain of these patent families, we have filed multiple patent applications. Collectively the patent applications include numerous independent claims and dependent claims. Several of our patent applications contain claims based upon unexpected and positive findings from the MARINE and ANCHOR trials. If granted, we believe that many of these resulting patents would expire in 2030. However, no assurance can be given that any of our patent applications will be granted or, if they grant, that they will prevent competitors from competing with AMR101. Securing additional patent protection for a product is a complex process involving many legal and factual questions. The patent applications we have filed in the U.S. and internationally are at varying stages of examination, the timing of which is outside our control. Many of our patent applications are unlikely to be examined by the U.S. Patent Office or other international patent offices during 2011. In addition, we may elect to submit, or patent office’s may require, additional evidence to support certain of the claims we are pursuing. Providing such additional evidence could result in us incurring additional costs. We cannot be certain what commercial value any granted patent in our patent portfolio will provide to us.

In order to commercialize AMR101, we must either develop a sales, marketing and distribution infrastructure or collaborate with third parties that have such experience. With the assistance of financial advisors, we have held discussions about collaboration and other strategic opportunities with larger pharmaceutical companies in the past, and may continue to hold such discussions in the future. These strategic opportunities may include licensing or similar transactions, joint ventures, partnerships, strategic alliances, business associations, or a sale of the company. However, no assurance can be given that we will enter into any such strategic transaction.

Until such time as we complete any such strategic transaction, if ever, we are continuing to develop plans to launch, market and sell AMR101 on our own. This includes making preparations for securing a sufficient commercial supply of AMR101 and expanding sales and marketing capabilities. In order to secure a sufficient commercial supply of AMR101, we have completed agreements for the supply of materials for AMR101 to provide for raw materials that are incremental to our existing Japan-based API supplier. Each agreement contemplates a phased capacity expansion plan aimed at creating sufficient capacity to meet anticipated demand for API material for AMR101 following FDA approval. These API suppliers are self-funding these expansion plans with contributions from Amarin. We are also considering adding a fourth API supplier. These agreements include requirements for the qualification of the suppliers’ material and facilities with the FDA prior to the commercial sale of any such material. We will make no purchase commitments until such time as these qualification events have been completed.

Opportunities to market and sell AMR101 outside of the United States are also under evaluation.

Unless we enter into a strategic collaboration in connection with the launch, marketing and sale of AMR101 to provide us with additional capital, we will need to raise additional capital on our own to support these efforts. We will also need additional capital to complete our REDUCE-IT cardiovascular outcomes trial. Additional financing may not be available when we need it or may not be available on terms that are acceptable to us. If adequate funds are not available to us on a timely basis, or at all, we may be required to delay the establishment of sales and marketing capabilities or terminate or delay our planned cardiovascular outcomes study. If we seek to raise additional funds, we may do so through the sale of additional equity, debt or convertible securities. Debt financing, if available, would result in increased fixed payment obligations and may involve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring debt, making capital expenditures or declaring dividends. The terms of any financings may be dilutive to, or otherwise adversely affect, holders of our outstanding securities. If we raise additional funds through collaboration, strategic alliance and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams or product candidates, or grant licenses on terms that are not favorable to us.

As of September 30, 2011, our cash balance was $125.9 million.

Financial Operations Overview

Revenue. We recorded no revenue in 2011 or 2010.

Research and Development Expense. Research and development expense consists primarily of fees paid to professional service providers in conjunction with independent monitoring of our clinical trials and acquiring and evaluating data in conjunction with our clinical trials, fees paid to independent researchers, costs of contract manufacturing, services expenses incurred in developing and testing products and product candidates, salaries and related expenses for personnel, including stock-based compensation expense, costs of materials, depreciation, rent, utilities and other facilities costs. In addition, research and development expenses include the cost to support current development efforts, including patent costs and milestone payments. We expense research and development costs as incurred.

Marketing, General and Administrative Expense. Marketing, general and administrative expense consists primarily of non-cash warrant related compensation expense attributable to October 2009 warrants issued to former employees, salaries and other related costs for current personnel, including stock-based compensation expense, in our executive, business development, marketing, finance and information technology functions. Other costs primarily include facility costs and professional fees for accounting, consulting and legal services.

Interest and Other (Income) Expense, Net. Interest expense consists of interest incurred under lease obligations. Interest income consists of interest earned on our cash and cash equivalents. Other income, net, consists primarily of foreign exchange gains and losses.

 

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Critical Accounting Policies and Significant Judgments and Estimates

There have been no changes in our critical accounting policies and significant judgments and estimates, as described in Note 2 to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2010 filed with the SEC on March 16, 2011.

Recent Accounting Pronouncements

From time to time, new accounting pronouncements are issued by FASB and are adopted by us as of the specified effective date. Unless otherwise discussed, we believe that the impact of recently issued accounting pronouncements will not have a material impact on consolidated financial position, results of operations, and cash flows, or do not apply to our operations.

Results of Operations

Comparison of Three Months Ended September 30, 2011 versus September 30, 2010

Revenue. We recorded no revenue in 2011 or 2010.

Research and Development Expense. Research and development expense for the three months ended September 30, 2011 was $6.0 million, versus $7.6 million in the prior year period, a decrease of $1.6 million, or 21.0%. Research and development expenses for the three months ended September 30, 2011 and 2010 are summarized in the table below:

 

     Three Months Ended
September 30
 
     2011      2010  

Research and development expenses, excluding non-cash expense (1)

   $ 5,607       $ 7,350   

Non-cash stock based compensation expense

     406         292   
  

 

 

    

 

 

 
   $ 6,013       $ 7,642   
  

 

 

    

 

 

 

 

(1) Research and development expense, excluding non-cash charges, for the three months ended September 30, 2011 was $5.6 million, versus $7.4 million in the prior year period, a decrease of $1.8 million, or 24.3%. The decrease in research and development expense was primarily due to lower costs in 2011 for our AMR101 cardiovascular program, primarily costs associated with our two Phase III clinical trials incurred through the clinical research organization (CRO) we engaged in late 2009 to help manage the two trials. We began enrolling patients in these trials in early 2010 and announced the completion of enrollment in both trials during the second half of 2010 with top-line results announced in November 2010 and April 2011 for the MARINE and ANCHOR trials, respectively. We estimate to incur approximately $2.0 million in additional CRO expenses to complete these studies.

Our estimate of remaining costs to be incurred to complete the MARINE and ANCHOR studies are significantly lower than the costs we included for these studies during 2010. However, we anticipate the decline in research and development expenditures for those two trials to be offset by an increase in clinical costs associated with our planned REDUCE-IT cardiovascular outcomes study. We currently estimate that cumulative costs incurred through a CRO for REDUCE-IT will not exceed $25 million by the end of 2012.

Marketing, General and Administrative Expense. Marketing, general and administrative expense for the three months ended September 30, 2011 was $3.4 million, versus $2.1 million in the prior year period, an increase of $1.3 million, or 61.9%. Marketing, general and administrative expenses for the three months ended September 30, 2011 and 2010 are summarized in the table below:

 

     Three Months Ended
September 30
 
     2011     2010  

Marketing, general and administrative expenses, excluding non-cash expense (1)

   $ 4,529      $ 1,631   

Non-cash stock based compensation expense (2)

     2,256        467   

Non-cash warrant related compensation (income) expense (3)

     (3,352     36   
  

 

 

   

 

 

 
   $ 3,433      $ 2,134   
  

 

 

   

 

 

 

 

(1) Marketing, general and administrative expense, excluding non-cash compensation charges for stock compensation and warrants, for the three months ended September 30, 2011 was $4.5 million, versus $1.6 million in the prior year period, an increase of $2.9 million, or 181.25%. The increase was primarily due to higher staffing and marketing related expenses in 2011 to prepare for the commercialization of AMR101.
(2) Stock based compensation expense for the three months ended September 30, 2011 was $2.3 million, versus $0.5 million in the prior year period, an increase of $1.8 million reflecting an increase in expense associated with option awards granted in 2010 and 2011 to attract and retain qualified employees.
(3)

Warrant related compensation income for the three months ended September 30, 2011 was $3.4 million, versus expense of $0.04 million in the prior year period. Warrant related compensation income for the three months ended September 30, 2011 reflects a non-cash change in fair value of the warrant derivative liability associated with warrants issued in October 2009 to former employees of Amarin, net of

 

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  warrants exercised. The decrease in the fair value of the warrants for the three months ended September 30, 2011 is due primarily to a decrease in our stock price between June 30, 2011 and September 30, 2011. We anticipate that the value of this warrant derivative liability may increase or decrease from period to period based upon changes in the price of our common stock. Such non-cash changes in valuation could be significant as the history of our stock price has been volatile. The gain or loss resulting from such non-cash changes in valuation could have a material impact on our reported net income or loss from period to period. In particular, if the price of our stock increases, the change in valuation of this warrant derivative liability will add to our history of operating losses.

We expect marketing, general and administrative costs, excluding non-cash warrant related compensation expense the value of which we cannot reasonably estimate, to increase as we prepare for the commercialization of AMR101, including costs for market research, sales force preparation and inventory management.

Gain/(Loss) on Change in Fair Value of Derivative Liability . Gain on change in fair value of derivative liability for the three months ended September 30, 2011 was a gain of $106.6 million versus a loss of $(1.4) million in the prior year period. Gain/(loss) on change in fair value of derivative liability is related to the change in fair value of warrants issued in conjunction with the October 2009 private placement. In October 2009 we issued 36.1 million warrants at an exercise price of $1.50 and recorded a $48.3 million warrant derivative liability, representing the fair value of the warrants issued. As these warrants have been classified as a derivative liability, they are revalued at each reporting period, with changes in fair value recognized in the statement of operations. The fair value of the warrant derivative liability at July 1, 2011 was $286.0 million and we recognized a $106.6 million gain on the change in fair value of derivative liability during the three months ended September 30, 2011 for these warrants. The fair value of the warrant derivative liability at July 1, 2010 was $72.4 million and we recognized a $(1.4) million loss on the change in fair value of derivative liability during the three months ended September 30, 2010. The decrease or increase in the fair value of the warrant derivative liability is due primarily to the decrease or increase in the price of our common stock on the date of valuation.

Interest (Income) Expense, net. Interest income includes interest earned on cash balances.

Other Income, net . Other income primarily includes gains and losses on foreign exchange transactions.

Comparison of Nine Months Ended September 30, 2011 versus September 30, 2010

Revenue. We recorded no revenue in 2011 or 2010.

Research and Development Expense. Research and development expense for the nine months ended September 30, 2011 was $15.7 million, versus $20.6 million in the prior year period, a decrease of $4.9 million, or 23.8%. Research and development expenses for the nine months ended September 30, 2011 and 2010 are summarized in the table below:

 

     Nine Months Ended
September 30
 
     2011      2010  

Research and development expenses, excluding non-cash expense (1)

   $ 14,751       $ 19,559   

Non-cash stock based compensation expense

     900         1,006   
  

 

 

    

 

 

 
   $ 15,651       $ 20,565   
  

 

 

    

 

 

 

 

(1) Research and development expense, excluding non-cash charges, for the nine months ended September 30, 2011 was $14.8 million, versus $19.6 million in the prior year period, a decrease of $4.8 million, or 24.5%. The decrease in research and development expense was primarily due to lower costs in 2011 for our AMR101 cardiovascular program, primarily costs associated with our two Phase III clinical trials incurred through the CRO we engaged in late 2009 to help manage the two trials. We began enrolling patients in these trials in early 2010 and completed enrollment in both trials during the second half of 2010. We estimate to incur approximately $2.0 million in additional expense through this CRO to complete these studies.

Our estimate of remaining costs to be incurred to complete the MARINE and ANCHOR studies are significantly lower than the costs we included for these studies during 2010. However, we anticipate the decline in research and development expenditures for those two trials to be offset by an increase in clinical costs associated with our planned cardiovascular outcomes study. We currently estimate that cumulative costs incurred through a CRO for REDUCE-IT will not exceed $25 million by the end of 2012.

Marketing, General and Administrative Expense. Marketing, general and administrative expense for the nine months ended September 30, 2011 was $16.2 million, versus $7.2 million in the prior year period, an increase of $9.0 million, or 125%. Marketing, general and administrative expenses for the nine months ended September 30, 2011 and 2010 are summarized in the table below:

 

     Nine Months Ended
September 30
 
     2011      2010  

Marketing, general and administrative expenses, excluding non-cash expense (1)

   $ 10,059       $ 5,343   

Non-cash stock based compensation expense (2)

     5,122         1,004   

Non-cash warrant related compensation expense (3)

     1,004         858   
  

 

 

    

 

 

 
   $ 16,185       $ 7,205   
  

 

 

    

 

 

 

 

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(1) Marketing, general and administrative expense, excluding non-cash compensation charges for stock compensation and warrants, for the nine months ended September 30, 2011 was $10.1 million, versus $5.3 million in the prior year period, an increase of $4.8 million, or 90.6%. The increase was primarily due to higher staffing and marketing related expenses in 2011 to prepare for the commercialization of AMR101.
(2) Stock based compensation expense for the nine months ended September 30, 2011 was $5.1 million, versus $1.0 million in the prior year period, an increase of $4.1 million, reflecting an increase in expense associated with option awards granted in 2010 and 2011 to attract and retain qualified employees.
(3) Warrant related compensation expense for the nine months ended September 30, 2011 was $1.0 million, versus $0.9 million in the prior year period. Warrant related compensation expense reflects the non-cash change in fair value of the warrant derivative liability associated with warrants issued in October 2009 to former employees of Amarin, net of warrants exercised. The decrease in the fair value of the warrants for the nine months ended September 30, 2011 is due primarily to an increase in our stock price between December 31, 2010 and September 30, 2011. We anticipate that the value of this warrant derivative liability may increase or decrease from period to period based upon changes in the price of our common stock. Such non-cash changes in valuation could be significant as the history of our stock price has been volatile. The gain or loss resulting from such non-cash changes in valuation could have a material impact on our reported net income or loss from period to period. In particular, if the price of our stock increases, the change in valuation of this warrant derivative liability will add to our history of operating losses.

We expect marketing, general and administrative costs, excluding non-cash warrant related compensation expense the value of which we cannot reasonably estimate, to increase as we prepare for the commercialization of AMR101, including costs for market research, sales force preparation and inventory management.

Loss on Change in Fair Value of Derivative Liability . Loss on change in fair value of derivative liability for the nine months ended September 30, 2011 was $53.4 million versus $33.4 million in the prior year period. Loss on change in fair value of derivative liability is related to the change in fair value of warrants issued in conjunction with the October 2009 private placement. In October 2009 we issued 36.1 million warrants at an exercise price of $1.50 and recorded a $48.3 million warrant derivative liability, representing the fair value of the warrants issued. As these warrants have been classified as a derivative liability, they are revalued at each reporting period, with changes in fair value recognized in the statement of operations. The fair value of the warrant derivative liability at December 31, 2010 was $230.1 million and we recognized a $53.4 million loss on change in fair value of derivative liability for the nine months period ended September 30, 2011 for these warrants. The fair value of the warrant derivative liability at December 31, 2009 was $41.5 million and we recognized a $33.4 million loss on change in fair value of derivative liability for the nine months period ended September 30, 2010. The decrease or increase in the fair value of the warrant derivative liability is due primarily to the decrease or increase in the price of our common stock on the date of valuation.

Interest (Income) Expense, net. Interest income includes interest earned on cash balances.

Other Income, net . Other income primarily includes gains and losses on foreign exchange transactions.

Liquidity and Capital Resources

Our sources of liquidity at September 30, 2011 include cash and cash equivalents of $125.9 million. Our projected uses of cash include commencement of the REDUCE-IT cardiovascular outcomes study, commercial preparation of AMR101, working capital and other general corporate activities. Our cash flows from operating, investing and financing activities, as reflected in the consolidated statements of cash flows, are summarized in the following table (in millions):

 

     Nine Months Ended
September 30,
 
     2011     2010  

Cash (used in) provided by continuing operations:

    

Operating activities

   $ (27.8   $ (24.4

Investing activities

     (1.7     —     

Financing activities

     123.9        3.6   
  

 

 

   

 

 

 

Increase (decrease) in cash and cash equivalents

   $ 94.4      $ (20.8
  

 

 

   

 

 

 

We had no debt obligations at September 30, 2011 or December 31, 2010.

In January 2011, we sold 13.8 million shares of our common shares, par value £0.50 per share, at a price of $7.60 per share, resulting in net proceeds of approximately $98.7 million after deducting underwriting commissions and expenses payable by us associated with this transaction.

We believe that our cash will be sufficient to fund our projected operations for the next twelve months which contemplates not only working capital and general corporate needs but also, commencement of a cardiovascular outcomes study and commercial preparations for AMR101. This is based on our current operational plans and activities at normal levels and does not assume any cash inflows from partnerships, warrant exercises or other dilutive or non-dilutive financings in the longer-term. If we elect to commercialize AMR101 ourselves, rather than through a collaborator, we will need additional funds to complete such activities. The sale of any equity or debt securities may result in additional dilution to our stockholders, and we cannot be certain that additional financing will be available in amounts or on terms acceptable to us, if at all.

 

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Contractual Obligations

The following table summarizes our contractual obligations at September 30, 2011 and the effects such obligations are expected to have on our liquidity and cash flows in future periods (in millions):

Payments Due by Period

 

     Total      2011      2012
to 2013
     2014
to 2015
     After 2015  

Contractual Obligations:

              

Purchase obligations (1)

   $ 13.4       $ 0.8       $ 12.6       $ —         $ —     

Operating lease obligations (2)

     1.5         0.6         0.7         0.2         —     
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total contractual cash obligations

   $ 14.9       $ 1.4       $ 13.3       $ 0.2       $ —     
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

 

(1) Represents minimum purchase obligations with our Japan-based supplier. We purchased $1.2 million of materials during the nine months ended September 30, 2011 and have additional purchase obligations of $12.6 million in 2012. Not included in this obligation is a non-refundable milestone payment of $0.5 million payable upon the first marketing approval of AMR101 in the United States. Additional future minimum purchases will be required, subject to an NDA approval, and in preparation for commercialization of AMR101 we may purchase more than the minimum amount.

In addition, provided the supplier has expanded its manufacturing capacity in accordance with the agreement, the supplier may terminate the agreement in the event that (i) Amarin does not receive marketing approval for AMR101 in the United States on or before December 31, 2014 or (ii) in the event that Amarin abandons development of AMR101 for hypertriglyceridemia in the United States. In either case, Amarin will be required to reimburse the supplier for certain costs incurred by the supplier in connection with its manufacturing expansion, less the amount of profit received as a result of purchases of ethyl-EPA by Amarin, not to exceed $5.0 million.

We anticipate incurring certain costs associated with the qualification of product produced by this Japan-based supplier. In an effort to further expand production capacity at this supplier or through the addition of supplemental suppliers, we may make capital commitments to support their expansion, particularly if such commitments further reduce the cost to us of the manufactured product.

 

(2) Represents operating lease costs, primarily consisting of leases for facilities in Dublin, Ireland, Mystic, CT and Bedminster, NJ.

We do not enter into financial instruments for trading or speculative purposes.

The above table also does not reflect potential material purchases under new agreements signed in the second quarter of 2011 for the supply of materials for AMR101 with two new API suppliers, Equateq and Chemport. These agreements provide access to additional API supply that is incremental to supply from our existing Japan-based API supplier. Each agreement contemplates a phased capacity expansion plan aimed at creating sufficient capacity to meet anticipated demand for API material for AMR101 following FDA approval. These API suppliers are self-funding these expansion plans with contributions from Amarin. These agreements include requirements for the suppliers to qualify their materials and facilities. We anticipate incurring certain costs associated with the qualification of product produced by these suppliers. Following FDA approval of AMR101 both agreements include annual purchase levels enabling Amarin to maintain supply exclusivity with each respective supplier, and to prevent potential termination of the agreements. Because we have not yet obtained FDA approval for AMR101, these amounts are excluded from the above table. The 2011 supply agreement with Equateq also includes (i) a one-time commitment fee of $1.0 million (paid in May 2011), (ii) development fees up to a maximum of $0.5 million, and (iii) material commitments of up to $5.0 million for initial raw materials, which will be credited against future API purchases, and is refundable to Amarin if Equateq does not successfully develop and qualify the API by a certain date. The $1.0 million commitment fee paid to Equateq in May 2011 is refundable if Equateq fails to satisfy certain capital sufficiency requirements. The 2011 supply agreement with Chemport includes, prior to a marketing approval, a raw material purchase commitment of $1.1 million. No payments have been made under this agreement as of September 30, 2011.

 

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Concurrent with the agreement with Chemport for commercial supply, we agreed to make a minority share equity investment in Chemport of up to $3.3 million. In July 2011, we paid to Chemport $1.7 million under this agreement, which has been included in other long term assets at September 30, 2011.

Under our 2004 share repurchase agreement with Laxdale Limited, in connection with commercialization of AMR101 for cardiovascular indications, prior to the end of 2012 we are required to pay potential royalties to a former employee of Laxdale of 1% on net sales up to £100 million (approximately $156 million at September 30, 2011); 0.5% for net sales between £100 million (approximately $156 million at September 30, 2011) and £500 million (approximately $781 million at September 30, 2011); and 0.25% for sales in excess of £500 million (approximately $781 million at September 30, 2011). In addition, under this same agreement with Laxdale Limited, upon receipt of marketing approval in the U.S. and/or Europe for the first indication for AMR101 (or first indication of any product containing Amarin Neuroscience intellectual property acquired from Laxdale Limited in 2004), we must make an aggregate stock or cash payment (at the sole option of each of the sellers) of £7.5 million (approximately $11.7 million at September 30, 2011) for each of the two potential marketing approvals (i.e. £15 million maximum, or approximately $23.4 million at September 30, 2011). In addition, upon receipt of a marketing approval in the U.S. or Europe for a further indication of AMR101 (or further indication of any other product using Amarin Neuroscience intellectual property), we must make an aggregate stock or cash payment (at the sole option of each of the sellers) of £5 million (approximately $7.8 million at September 30, 2011) for each of the two potential market approvals (i.e. £10 million maximum, or approximately $15.6 million at September 30, 2011).

In addition to the obligations in the table above, we have approximately $0.5 million of gross liability for uncertain tax positions that have been recorded as liabilities at December 31, 2010. We are not able to reasonably estimate in which future periods these amounts will ultimately be settled.

Off-Balance Sheet Arrangements

We do not have any special purpose entities or other off-balance sheet arrangements.

Shelf Registration Statement

On March 29, 2011, we filed with the SEC a universal shelf registration statement on Form S-3 (Registration No. 333-173132), which provides for the offer, from time to time, of an indeterminate and unlimited amount of: ordinary shares, which may be represented by American Depositary Shares; preference shares, which may be represented by American Depositary Shares; senior or subordinated debt securities; warrants to purchase any of these securities; and any combination of these securities, individually or as units. In addition, if we identify any security holder(s) in a prospectus supplement, they may also offer identified securities under this registration statement although we will not receive any of the proceeds from the sale of securities by any of these selling security holders. This universal shelf registration statement was automatically effective upon its filing. The addition of any newly issued equity securities into the market may be dilutive to existing stockholders and new issuances by us or sales by our selling security holders could have an adverse effect on the price of our securities.

 

Item 3. Quantitative and Qualitative Disclosures about Market Risk

We are exposed to market risks, which include changes in interest rates, changes in credit worthiness and liquidity of our marketable securities. We do not use derivative financial instruments in our investment portfolio and have no foreign exchange contracts. We record as a liability the fair value of warrants to purchase 18.7 million shares of our common stock issued to investors. The fair value of this warrant liability is determined using the Black-Scholes option valuation model and is therefore sensitive to changes in the market price and volatility of our common stock among other factors. In the event of a hypothetical 10% increase in the market price of our common stock ($10.12 based on the $9.20 market price of our stock at September 30, 2011) on which the September 30, 2011 valuation was based, the value would have increased by $16.8 million. Such increase would have been reflected as a reduction in the gain on revaluation of the warrant liability in our statement of operations.

 

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) is (1) recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and (2) accumulated and communicated to our management, including our principal executive officer and principal financial officer, to allow timely decisions regarding required disclosure.

As of September 30, 2011, our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our principal executive officer and principal financial officer have concluded based upon the evaluation described above that, as of September 30, 2011, our disclosure controls and procedures were not effective at the reasonable assurance level, due to a material weakness in internal control over financial reporting described below.

 

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Changes in Internal Control over Financial Reporting

During the three months ended September 30, 2011, there have been no changes in our internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15(d)-15(f) under the Exchange Act, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting, other than as described below.

As previously described in Item 9A “Controls and Procedures” in our Annual Report on Form 10-K filed for the year ended December 31, 2010, our management identified a material weakness in internal control over financial reporting as of December 31, 2009 and which persisted on December 31, 2010. Specifically, our management concluded there was a deficiency in the company’s internal control over financial reporting relating to the technical expertise and review over the accounting for complex, non-routine transactions that could result in a material misstatement of the consolidated financial statements that would not be prevented or detected on a timely basis. In response to this material weakness, our management, with the input, oversight, and support of the Audit Committee, identified and took the following steps beginning during the second half of 2010 and all of which efforts continued into the third quarter of 2011: non-ordinary course transactions are considered and evaluated by senior finance management; we continue to prepare accounting position papers for all complex transactions; and, where appropriate, management seeks the advice of outside consultants on accounting matters related to the application of U.S. GAAP to complex, non-ordinary course transactions and in other instances as warranted.

PART II – OTHER INFORMATION

 

Item 1. Legal Proceedings

In the ordinary course of business, we are from time to time involved in lawsuits, claims, investigations, proceedings, and threats of litigation relating to intellectual property, commercial arrangements and other matters. While the outcome of these proceedings and claims cannot be predicted with certainty, there are no matters, as of September 30, 2011, that, in the opinion of management, might have a material adverse effect on our financial position, results of operations or cash flows.

 

Item 1A. Risk Factors

Investment in our securities involves a high degree of risk. Our Annual Report on Form 10-K for the year ended December 31, 2010, which was filed with the SEC on March 16, 2011, contains numerous risk factors relating to our business and operations, our intellectual property, clinical trials, regulatory matters, our dependence on third parties, our industry and our common stock.

The following risk factors are either new or have changed materially from those set forth in our Annual Report on Form 10-K for the year ended December 31, 2010. You should carefully review the risks involved and those described in our Annual Report on Form 10-K and in other reports we file with the Securities and Exchange Commission in evaluating our business.

There can be no assurance that the FDA will accept the NDA we submitted to the FDA in September 2011, nor can there be any assurance that the NDA will be approved.

On September 26, 2011 we submitted an NDA to the FDA seeking approval to market and sell AMR101 in the United States for the indication studied in the MARINE trial (for the treatment of patients with very high triglycerides). After submission of an NDA, the FDA may refuse to file the application, deny approval of the application and/or require additional testing or data. In the event the FDA takes any such action, such actions would have a material adverse effect on our operations and financial condition.

We will require substantial additional resources to fund our operations and to develop our product candidates. If we cannot find additional capital resources, we will have difficulty in operating as a going concern and growing our business.

We currently operate with limited resources. At September 30, 2011, we had cash and cash equivalents of approximately $125.9 million. We believe that our current resources will be sufficient to fund our projected operations for the next twelve months, which contemplates not only working capital and general corporate needs but also commercial preparation of AMR101 and the initiation of the REDUCE-IT cardiovascular outcomes study. In order to commercialize AMR101, we must either develop a sales, marketing and distribution infrastructure or collaborate with third parties that have such experience. We plan to consider collaboration opportunities with larger pharmaceutical companies for the launch, marketing and sale of AMR101. Although we are in discussions with pharmaceutical companies regarding such collaboration, there can be no assurance that these discussions will result in any such transaction. Accordingly, we are also developing plans to launch, market and sell AMR101 in the United States on our own.

If we do not enter into a strategic collaboration in connection with the launch, marketing and sale of AMR101, we will need to raise additional capital to support these efforts. We will also need additional capital to complete our REDUCE-IT cardiovascular outcomes trial.

 

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If we seek to raise additional funds, we may do so through the sale of additional equity, debt, convertible securities or a combination of these securities. Debt financing, if available, would result in increased fixed payment obligations and may involve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring debt, making capital expenditures or declaring dividends. The terms of any financings may be dilutive to, or otherwise adversely affect, holders of our outstanding securities. There can be no assurance that additional financing will be available in amounts or on terms acceptable to us, if at all. If we raise additional funds through collaboration, strategic alliance and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams or product candidates, or grant licenses on terms that are not favorable to us. Any inability to obtain additional funds when needed would have a material adverse effect on our business and on our ability to operate on an ongoing basis.

Our future capital requirements will depend on many factors, including:

 

   

whether or not we enter into a strategic collaboration in connection with the launch, marketing and sale of AMR101;

 

   

whether or not we elect to commence an outcomes study to support the filing of an NDA for the clinical indication evaluated in the ANCHOR trial;

 

   

time and costs involved in obtaining regulatory approvals for AMR101;

 

   

number of additional product candidates we may pursue;

 

   

costs involved in filing and prosecuting patent applications and enforcing or defending patent claims; and

 

   

the costs associated with commercializing our product candidates if they receive regulatory approval, including the cost and timing of developing sales and marketing capabilities, or entering into strategic collaboration with others relating to the commercialization of our product candidates.

If we do not enter into a collaboration agreement as described above, or if adequate funds are not available to us in amounts or on terms acceptable to us or on a timely basis, or at all, we may be required to terminate or delay our development efforts in support of our product candidates, or delay the advancement of the REDUCE-IT cardiovascular outcomes trial, or delay our establishment of sales and marketing capabilities or other activities that may be necessary to commercialize AMR101 in the event we obtain regulatory approval for this product candidate.

In order to commercialize any future product that is approved for marketing, we may need to find a collaborative partner to help with marketing and sales.

In order to commercialize AMR101, we must either develop a sales, marketing and distribution infrastructure or collaborate with third parties that have such experience. We plan to consider collaboration opportunities with larger pharmaceutical companies for the launch, marketing and sale of AMR101. If we do complete such a collaboration agreement, we will be reliant on one or more of these strategic partners to generate revenue on our behalf. Until such time as we complete any such strategic transaction, if ever, we are continuing to develop plans to launch, market and sell AMR101 on our own. This includes making preparations for securing a sufficient commercial supply of AMR101 and expanding sales and marketing capabilities and would require that we build a substantial commercialization infrastructure in order to compete with larger companies with established marketing and sales capabilities.

We may not be successful in finding a collaborative partner to help market and sell our products, or may be delayed in doing so, in which case we would not receive revenue or royalties on the timeframe and to the extent that we currently anticipate. We face significant competition in seeking appropriate collaborators and these collaborations are complex and time-consuming to negotiate and document. We may not be able to negotiate collaborations on acceptable terms, or at all. If that were to occur, we may have to curtail the development of a particular product candidate, reduce or delay its development program or one or more of our other development programs, delay its potential commercialization or reduce the scope of our sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense. If we elect to increase our expenditures to fund development or commercialization activities on our own, we will need to obtain additional capital, which may not be available to us on acceptable terms, or at all. If we cannot raise sufficient funds, we will not be able to bring our product candidates to market and generate product revenue.

For example, in October 2009, we announced our heightened strategic and operating focus on cardiovascular disease and our cessation of research and development of product candidates to treat central nervous system disorders. Subsequent to October 2009, we did not receive any acceptable offers to acquire, out-license or otherwise continue the development of any of these product candidates to treat central nervous system disorders.

We may experience delays in the initiation of our cardiovascular outcomes study, or such outcomes study may take longer and cost more than we expect. The FDA may not approve our request to consider the indication studied in the ANCHOR trial in conjunction with the FDA’s review of the indication studied in the MARINE trial.

In order to obtain a separate indication for AMR101 based on the ANCHOR trial results, our SPA with the FDA requires that we have a cardiovascular outcomes study substantially underway at the time of the NDA submission. In August 2011, we reached a agreement with the FDA on an SPA for the design of the cardiovascular outcomes study of AMR101, titled REDUCE-IT (Reduction of Cardiovascular Events with EPA – Intervention Trial). REDUCE-IT, is a multi-center, prospective, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effectiveness of AMR101 in reducing first major cardiovascular events in an at-risk patient population. The control arm of the study will be patients on optimized statin therapy. The active arm of the study will be patients on optimized statin therapy plus AMR101. All subjects enrolled in the study will have elevated triglyceride levels and either coronary heart disease or risk factors for coronary heart disease. This study will be conducted internationally. Based on the results of REDUCE-IT, we may seek additional indications for AMR101 beyond the indication studied in the ANCHOR trial such as prevention of cardiac events, although there can be no assurance as to whether the results of REDUCE-IT will support any such indication.

 

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In the event we experience delays in initiating or achieving substantial enrolment for REDUCE-IT, our filing of a supplemental NDA (sNDA) seeking approval of an indication based on the ANCHOR trial results will be delayed.

In accordance with our SPA for the ANCHOR trial, we currently intend to file a sNDA seeking approval of the indication studied in the ANCHOR trial once we have a cardiovascular outcomes study substantially underway. The sNDA cannot be filed until after both the initially submitted NDA is approved and the cardiovascular outcomes study is substantially underway. However, as part of our interaction with the FDA regarding our NDA for the indication studied in the MARINE trial, we may explore whether there is an opportunity for the indication studied in the ANCHOR trial to be considered in conjunction with the FDA’s review of the indication studied in the MARINE trial once the REDUCE-IT trial is substantially underway. However, there can be no assurance that the FDA will approve such an approach. If the FDA requires additional enrollment, our ability to seek approval for the indication evaluated in the ANCHOR trial could be delayed.

The REDUCE-IT cardiovascular trial may fail to achieve its clinical endpoints, and the long-term clinical results of AMR101 may not be consistent with the clinical results we observed in our Phase 3 pivotal trials.

In accordance with the SPA for our MARINE and ANCHOR trials, efficacy was evaluated in these trials compared to placebo at twelve weeks. No placebo-controlled studies have been conducted regarding the long-term effect of AMR101 on lipids and no outcomes study has been conducted evaluating AMR101. Outcomes studies of certain other lipid modifying therapies have failed to achieve the endpoints of such studies. There can be no assurance that the endpoints of the REDUCE-IT cardiovascular outcomes study will be achieved or that the lipid modifying effects of AMR101 in REDUCE-IT or any other study of AMR101 will not be subject to variation beyond twelve weeks. If the REDUCE-IT trial fails to achieve its clinical endpoints or if the results of these long-term studies are not consistent with the clinical results it could prevent us from expanding the label of any approved product.

Even if we obtain marketing approval for AMR101 in the United States, there can be no assurance as to the final indication approved by the FDA, and the actual number of patients with the condition included in such approved indication may be smaller than we anticipate.

There can be no assurance as to the final indication approved by the FDA in the event that marketing approval is obtained. Even if marketing approval is obtained, the number of actual patients with the condition included in such approved indication may be smaller than we anticipate. Even if we obtain marketing approval, the FDA may impose restrictions on the product’s conditions for use, distribution or marketing and in some cases may impose ongoing requirements for post-market surveillance, post-approval studies or clinical trials. If any such approved indication is narrower than we anticipate, the market potential for our product candidate would suffer.

The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription products. If we are found to have improperly promoted off-label uses, we may become subject to significant liability.

The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription products. In particular, a product may not be promoted for uses that are not approved by the FDA or such other regulatory agencies as reflected in the product’s approved labeling. If we receive marketing approval for AMR101, physicians may nevertheless prescribe AMR101 to their patients in a manner that is inconsistent with the approved label. If we are found to have promoted such off-label uses, we may become subject to significant liability. The federal government has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined several companies from engaging in off-label promotion. The FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed.

We may become subject to product liability claims as a result of our prior sales and marketing activities related to Permax.

Amarin was responsible for the sales and marketing of Permax ® (pergolide mesylate), as an adjunctive treatment for Parkinson’s disease, from May 2001 until February 2004. On May 17, 2001, Amarin acquired the U.S. sales and marketing rights to Permax from Elan Corporation, or Elan. An affiliate of Elan had previously obtained the licensing rights to Permax from Eli Lilly and Company in 1993. Eli Lilly originally obtained approval for Permax on December 30, 1988, and has been responsible for the manufacture and supply of Permax since that date. On February 25, 2004, Amarin sold its U.S. subsidiary, Amarin Pharmaceuticals, Inc., including the rights to Permax, to Valeant Pharmaceuticals.

On March 29, 2007, the FDA announced that the manufacturers of pergolide drug products would voluntarily remove these drug products, including Permax, from the market because of the risk of serious damage to patients’ heart valves. Further information about the removal of Permax and other pergolide drug products is available on the FDA’s website.

Six cases alleging claims related to cardiac valvulopathy and Permax were filed in April 2008 in the United States and currently remain pending. Eli Lilly, Valeant, Amarin Pharmaceuticals (sold to Valeant in 2004 as described above) and unidentified parties were named as defendants in these cases. Amarin was never named as a defendant or served with the complaints from these cases. We understand that, as of the date of this Quarterly Report on Form 10-Q, all of these cases have either settled or been dismissed.

We may become subject to liability in connection with the wind-down of our EN101 program.

In 2007, we purchased Ester Neurosciences Limited, an Israeli pharmaceutical company, and its lead product candidate, EN101, an AChE-R mRNA inhibitor for the treatment of myasthenia gravis, or MG, a debilitating neuromuscular disease. In connection with the acquisition, we assumed a license to certain intellectual property assets related to EN101 from the Yissum Research Development Company of The Hebrew University of Jerusalem.

In June 2009, in keeping with our decision to re-focus our efforts on developing improved treatments for cardiovascular disease and cease development of all product candidates outside of our cardiovascular disease focus, we amended the terms of our acquisition agreement with the original shareholders of Ester. Under the terms of this amendment, Amarin was released from all research and development diligence obligations contained in the original agreement and was authorized to seek a partner for EN101. The amendment agreement also provided that

 

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any future payment obligations payable by Amarin to the former shareholders of Ester would be made only out of income received from potential partners. In connection with this amendment agreement, in August 2009 we issued 1,315,789 ordinary shares to the former Ester shareholders. Under the terms of this amendment agreement, the former Ester shareholders have the option of reacquiring the original share capital of Ester if we are unable to successfully partner EN101.

Following our decision to cease development of EN101, Yissum terminated its license agreement with Amarin. In June 2011 Yissum announced that it had entered into a license agreement with BiolineRX Ltd for the development of EN101 in a different indication, Inflammatory Bowel Disease.

We have received correspondence on behalf of the former shareholders of Ester asserting that Amarin is in breach of its amended agreement due to the fact that the Yissum terminated its license and Amarin failed to return shares of Ester, and assets relating to EN101, to the shareholders, as was required under certain circumstances under the amended agreement. We do not believe these circumstances constitute a breach of the amended agreement, but there can be no assurance as to the outcome of this dispute.

There can be no assurance that any of our pending patent applications relating to AMR101 or its use will issue as patents.

We have filed and are prosecuting numerous patent applications in the U.S. and internationally. In the U.S. we have filed patent applications which seek to expand to eleven the number of patent families protecting the proprietary position of AMR101. For certain of these patent families, we have filed multiple patent applications. Collectively the patent applications include numerous independent claims and dependent claims. Several of our patent applications contain claims that are based upon unexpected and positive findings from the MARINE and ANCHOR trials. If granted, many of these patents would expire in 2030. However, no assurance can be given that any of our patent applications will be granted or, if they grant, that they will prevent competitors from competing with AMR101. The patent applications we have filed in the U.S. and internationally are at varying stages of examination, the timing of which is outside our control. We cannot be certain what commercial value any granted patent in our patent estate will provide to us.

The process of obtaining a patent can be lengthy, during which patent claims may undergo substantial modification before allowance and could result in significantly reduced coverage for a product. There can be no assurance that the U.S. Patent Office or international patent offices will find the our arguments in support of patentability to be persuasive. The timing of the patent examination process is independent of and has no effect on the timing of the FDA’s review of our NDA.

 

Item 6. Exhibits

The following exhibits are incorporated by reference or filed as part of this report.

 

Exhibit

Number

      
  10.1    Stuart Sedlack offer letter, dated August 1, 2007.
  10.2    Online Office Agreement dated as of September 30, 2011 by and between Amarin Corporation plc and Regus CME Ireland Ltd.
  31.1    Certification of Chief Executive Officer (Principal Executive Officer) pursuant to Section 302 of Sarbanes-Oxley Act of 2002.
  31.2    Certification of President (Principal Financial Officer) pursuant to Section 302 of Sarbanes-Oxley Act of 2002.
  32.1    Certification of Chief Executive Officer (Principal Executive Officer) and President (Principal Financial Officer) pursuant to Section 906 of Sarbanes-Oxley Act of 2002.
101.INS    XBRL Instance Document*
101.SCH    XBRL Taxonomy Extension Schema Document*
101.CAL    XBRL Taxonomy Extension Calculation Linkbase Document*
101.DEF    XBRL Taxonomy Extension Definition Linkbase Document*
101.LAB    XBRL Taxonomy Extension Label Linkbase Document*
101.PRE    XBRL Taxonomy Extension Presentation Linkbase Document*

 

* Pursuant to Rule 406T of Regulation S-T, these interactive data files are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section 18 of the Exchange Act and otherwise are not subject to liability under those sections.

 

21


Table of Contents

SIGNATURE

Pursuant to the requirements of Section 13 or 15(d) of the Exchange Act, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

A MARIN C ORPORATION P LC
By:  

/s/ John F. Thero

  John F. Thero
  President (Principal Financial Officer)

Date: November 8, 2011

 

22

Exhibit 10.1

LOGO

First Floor, Block 3, The Oval, Shelbourne Road, Ballsbridge, Dublin 4, Ireland.

Tel: +353 (0) 1 669 9020    Fax: +353 (0) 1 669 9028

August 1, 2007

Mr. Stuart Sedlack

15505 Carrs Mill Road

Woodbine, MD 21797

Dear Stuart,

I refer to our recent conversations regarding your proposed appointment to the position of Vice President, Business Development. I am delighted to offer you this position on the following terms.

For the purposes of this letter “Amarin” shall mean Amarin Corporation plc and its Affiliates. “Affiliates” shall mean any corporation or other business entity which is part of the same enterprise grouping as Amarin and which is controlled by, is under common control with, or controls the party, where control includes the ability to vote at least a majority of the voting shares of an entity.

1. Role/Title

Your title will be Executive Vice President, Strategic Development reporting to Alan Cooke, President and Chief Financial Officer. Initially you will be employed by Amarin Pharmaceutical Ireland Limited. Once an Affiliate of Amarin is established in the US, you will be employed by that Affiliate. For the avoidance of doubt the terms of this Offer Letter will apply to your employment by any such Affiliate.

Specifically, you will be required to perform the role of Vice President, Business Development and to perform such other duties as may be assigned to you from time to time.

2. Commencement Date/Location

As discussed, your starting date will be as soon as is practicable following your departure from your current employment (“ Commencement Date ”). You will work from home and you may be required to work at other locations from time to time. When we have established an office on the East coast of the U.S., which is likely to be in New Jersey, we will discuss your attendance requirements at that office in addition to your work from your home office. Normal office hours are from 9.00 am to 5.00 pm Monday to Friday. However, your duties are critical to the smooth running of the operation and as such you may be required to work outside these hours.


3. Compensation

Amarin shall pay you the sum of US$265,000 gross per annum payable on or around the last Friday in each calendar month.

4. Stock Options

You will be entitled to the grant of options over 300,000 ordinary shares in Amarin Corporation plc of 5 pence each (equivalent to 300,000 American Depositary Receipts) which will vest one third on the first anniversary of the option grant date and the reminder in equal amounts over the following two anniversary dates. These options will be priced, approved and granted at the first remuneration committee meeting following the date of signature of this employment contract and your commencement of employment with Amarin. The provisions of the Amarin Corporation plc 2002 Stock Option Plan (as may be amended from time to time) shall apply to any options granted.

5. Bonus

You will be entitled to be considered for a discretionary bonus for each calendar year served with Amarin up to a maximum of 50% of your annual salary although any such bonus shall be payable in the absolute discretion of Amarin’s management having regard to the performance of the Amarin group as a whole and in the light of your own personal performance during such year. Additionally, in the event that Amarin’s management determines, in its absolute discretion, to make an annual performance stock option grant to senior management, you will be entitled to be considered for such a grant.

6. Health Insurance

Amarin will reimburse you for the cost of your existing health and life insurance schemes, assuming the benefits and costs are somewhat comparable to the cost and benefits of those schemes offered to existing employees.

7. Pension

Amarin will pay 6% of your gross salary into your self-directed retirement account. Currently our pension benefit is undergoing a review at group level. If this review changes the pension contribution % for senior management, your contribution will be adjusted accordingly.

8. Expenses

Amarin shall reimburse you for all reasonable expenses that you are authorised to incur whilst carrying out your duties on behalf of Amarin. You must follow the correct claims procedure and provide invoices or other evidence of payment in order to be reimbursed.

9. Hours of work

Your normal hours of work shall be 35 hours per week, although Amarin expects you to work such hours and at such times as may be reasonably necessary in order for you to carry out your duties effectively. There is no entitlement to payment for overtime.


10. Holidays

You are entitled to paid holidays of 24 days per annum, excluding statutory and customary holidays. The holiday year is from 1 January to 31 December and unused holiday entitlement may not be carried forward. Holidays must be taken at times convenient to Amarin and sufficient notice of intention to take holiday must be given to accommodate the needs of the business.

11. During working hours you shall devote all of your time, attention and skill to Amarin’s business and interests in a proper and efficient manner, and shall use your best efforts to further and promote Amarin’s business and to act loyally and faithfully to Amarin.

12. Confidential Information and Company Documents

You shall neither during your engagement with Amarin (except in the proper performance of your duties) nor at any time after the termination of your engagement with Amarin:

 

  (a) divulge or communicate to any person, company, business entity or other organisation;

 

  (b) use for your own purposes or for any other purposes other than those of Amarin or any Affiliate; or

 

  (c) through any failure to exercise due care and diligence, permit or cause any unauthorised disclosure of

any Confidential Information. These restrictions shall cease to apply to any information which shall become available to the public generally otherwise than through your default.

“Confidential Information” shall mean any proprietary information of Amarin, including, without limitation, information relating to products, processes, services, businesses, personnel, research, financial strategies and activities, commercial strategies and activities, formulas, materials, compounds, substances, programmes, devices, concepts, inventions, patents, designs, methods, techniques, intellectual property, marketing strategies, data, trade secrets, know-how, plans, operations, tests, studies, manuals, market reports, customers, financial status, cash flow projections and the like or any other matter connected with the business of Amarin, or any of its suppliers, partners or customers related to Amarin or its business.

All books, notes, memoranda, records, lists of customers and suppliers and employees, correspondence, documents, computer and other discs, tapes and other data storage, date listings, codes, designs, and drawings and other documents and material whatsoever (whether made or created by you or otherwise) relating to the business of Amarin (and copies of the same):

 

  (a) shall be and remain the property of Amarin or the relevant Affiliate; and


  (b) shall be handed over by you to Amarin or to the relevant Affiliate on demand and in any event on the termination of your engagement with Amarin.

13. Termination of Employment

 

13.1 Subject to clause 13.2, you are entitled to give and receive from Amarin 12 months notice of the termination of your employment. If written notice is given by you or by Amarin to terminate your employment, Amarin may, notwithstanding any other terms of these terms and conditions and in its absolute discretion, require you to:

 

  (a) continue to perform such duties as Amarin may direct or to perform no duties during the period of your notice provided always that it shall continue to pay you your salary and provide all contractual benefits to which you are entitled during such notice period. You agree that, during any part of any period of notice, you will not work for any other employer;

 

  (b) accept a payment of salary in lieu of notice and your employment shall terminate immediately but without prejudice to any other claim Amarin or you may have against the other.

 

13.2 In the event that Amarin serves notice of termination of your employment under clause 13.1 within the first 18 months following the Commencement Date, in addition to your rights set forth in Clause 13.1, following the expiry of the 12 months notice period (“ Initial Notice Period ”), you shall be entitled to act as a consultant to Amarin on a month to month basis from the expiry of the Initial Notice Period until the earlier of (a) the thirty month anniversary of the Commencement Date and (b) the date upon which you accept an offer of employment with a third party (“ Optional Consultancy Period ”). During the Optional Consultancy Period, you will be required to provide transitional consultancy services to Amarin of 5 hours each month at a rate of $200 per hour.

14. Termination without Notice

In cases of gross misconduct Amarin may terminate your engagement immediately without notice and without liability for compensation or damages. In the event of a dispute arising in respect of any such termination by Amarin this dispute will be governed by the laws of the State of New York and shall be subject to the exclusive jurisdiction of the courts of New York.

15. Sickness

If you are ill and unfit for work, you must personally contact your manager as early as possible on the first day and comply with the absence policy as detailed in the handbook.


If you are ill for less than 7 consecutive days (including weekends) you must complete a self certification form. For longer periods of illness a Doctor’s certificate must be supplied and additional ones sent to cover the whole period of sickness.

Company Sick Pay may be paid at Amarin’s absolute discretion as follows in a rolling 12 month period:

 

Length of continuous employment on

commencement of absence

  

Period for which full pay is

normally payable in a twelve

month period

Up to 1 year    4 weeks
Over 1 year and up to 3 years    8 weeks
Over 3 years and up to 5 years    13 weeks
Over 5 years    26 weeks

Amarin may at any time require you to have a medical examination at Amarin’s expense.

Should you have, or develop a condition that could be described as a disability you have a duty to inform us so that any reasonable adjustment may be made to your work or working environment. This disclosure would be treated in strictest confidence and you would not be discriminated against in any way.

16. Intellectual Property Rights

It shall be part of your contractual duties (whether alone or with any other employee of Amarin or any Affiliate) at all times to further the interests of Amarin and, without prejudice to the generality of the foregoing and to the extent as is consistent with the your role within Amarin;

 

  (a) to make, discover and conceive inventions, processes, techniques, designs, improvements or developments relating to or capable of use or adaptation for use in connection with the business of Amarin or any Affiliate (“an Invention”)

 

  (b) to consider in what manner and by what new methods or devices the products, services, processes, equipment or systems of Amarin or any Affiliate with which you are concerned or for which you are responsible, might be improved (“a Development”);

 

  (c) promptly to give to Amarin or any Affiliate full details of any such Invention or Development which you may from time to time make or discover in the course of your engagement with Amarin; and

 

  (d) to further the interests of Amarin’s or any Affiliate’s undertaking with regard thereto


and Amarin or any Affiliate shall be entitled to the exclusive ownership of any such Invention or Development and to the exclusive use thereof.

You shall immediately give full information to the board of directors of Amarin (the “Board”) as to such Invention or Development and the exact mode of working, producing, using and exploiting the same and shall also give all such explanations and instructions to the Board as may be necessary or useful to enable Amarin or any Affiliate to obtain full benefit of them and will at the expense of Amarin or any Affiliate furnish it with all necessary plans, drawings, formulae and models applicable to the same and shall at the cost and expense of Amarin or any Affiliate execute all documents and do all acts and things necessary to enable Amarin or any Affiliate (or its or their nominees) to apply for and obtain protection for such Inventions and Developments throughout the world and for vesting the ownership of them in Amarin or any Affiliate (or its or their nominees).

You shall not knowingly do anything to imperil the validity of any patent or protection related to the business of Amarin or any Affiliate or any application therefore but shall at the expense of Amarin or any Affiliate render all possible assistance to Amarin or any Affiliate, both in obtaining and in maintaining such patents or other protection.

You shall not either during your engagement with Amarin or any time thereafter exploit or assist others to exploit any Invention or Development which you may from time to time make or discover in the course of your engagement with Amarin or (unless the same shall have become public knowledge otherwise than by breach by you of the terms of this Offer Letter) make public or disclose any such Invention or Development or improvement or give any information in respect of the same except to Amarin or any Affiliate or as it may direct.

You hereby irrevocably appoint Amarin or any Affiliate to be your attorney in your name and on your behalf to execute all documents and do all things necessary and generally to use your name for the purpose of giving Amarin or any Affiliate (or its or their nominees) the full benefit of the provisions of this clause and in favour of any third party a certificate in writing signed by any director or the secretary of Amarin or any Affiliate that any instrument or act which falls within the authority conferred by this clause which shall be conclusive evidence that such is the case.

Copyright and unregistered design rights in all works created by you in the course of your engagement with Amarin will, in accordance with the Copyright Designs and Patent Act 1988, vest in Amarin or any Affiliate. Rights in any design registerable pursuant to the Registered Designs Act 1949, (as amended) (the “Act”) created by you in the course of your engagement with Amarin shall, in accordance with the Act, vest in Amarin or any Affiliate.

17. Restrictions during employment

During the course of your engagement with Amarin, you shall not:

 

(a) be directly or indirectly employed, engaged, concerned or interested in any other business or undertaking; or


(b) engage in any activity which the Board reasonably considers may be, or become, harmful to the interests of Amarin or any Affiliate or which might reasonably be considered to interfere with the performance of your duties under this Agreement.

The above provisions shall not apply:

 

(a) to the holding by you (directly or through nominees) of investments listed on the London Stock Exchange or in respect of which dealing takes place in the Unlisted Securities Market on the London Stock Exchange or any recognised stock exchange as long as you do not hold more than 5 % of the issued shares or other securities of any class of any one company; or

 

(b) to any act undertaken by you with the prior written consent of the Board; or

 

(c) to any interest permitted with the prior approval of the Board (such interest not to be unreasonably withheld) for you to serve from time to time and continue to serve on the boards of, and hold any other offices or positions in, companies or organisations which will not present any conflict of interest with Amarin or any Affiliate and provided that such activities do not materially detract from the performance of your duties;

 

(d) to your serving as a member of the Business Advisory Board of Fountain Healthcare Partners on the basis of a maximum time commitment of 2 half days per calendar quarter and provided that, save with the prior approval of Amarin’s Chief Financial Officer, you shall exclude yourself from any involvement in any assignments or discussions with Fountain Healthcare Partners which may present any conflict of interest with the business or affairs of Amarin or any of its Affiliates.

18. Share Dealings

You shall comply fully with Amarin’s Share Dealing Code.

19. Conditions of offer

This offer of employment is conditional upon:

 

(a) receipt by the Amarin of two satisfactory employment references, one of which must be given by your current employer. Please provide names and addresses of two referees, who may be contacted immediately;

 

(b) receipt of original professional and educational qualifications (where requested);

 

(c) all pre-employment checks being acceptable to the Amarin.


If you choose to accept the offer on the above terms and conditions, please sign and return the copy of this Offer Letter to our General Counsel, Tom Maher at Amarin, First Floor, Block 3, The Oval, Shelbourne Road, Ballsbridge, Dublin 4.

We look forward to you joining our company and I am sure you will have a successful and challenging career with Amarin.

 

Signed for and on behalf of

 

AMARIN CORPORATION plc

/s/ Alan Cooke

Alan Cooke
Director, President and CFO

I hereby accept and agree to be bound by the terms and conditions of the Offer Letter set out above.

 

Signed

 

/s/ Stuart Sedlack

Name

  Stuart Sedlack

Dated

 

1 August 2007

Exhibit 10.2

 

Regus    30/09/2011

 

LOGO    Online Office Agreement

 

 

 

Agreement Date: Friday, September 30, 2011    Confirmation No: 32768-146551

 

Business Center Details       Client Details
DUBLIN, 2 Pembroke House       Company Name    Amarin Corporation
Address    Upper Pembroke Street 28-32    Contact Name    Conor Dalton
   Dublin   

 

Address

  

 

1st Floor

The Oval

Shelbourne Road

Dublin

D4

Republic of Ireland

   Republic of Ireland      

 

Sales Manager

  

 

Althaea Federlein

     
        
        
        
      Phone    +353(0)862715407
      Email    conor.dalton@amarincorp.com

Office Payment Details (exc. tax and exc. services)

 

Office Number    Number of people
305    1
308    1
309    1

 

Initial Payment:    First month’s fee:    0.00
   Service Retainer:    5,400.00
   Total Initial Payment:    5,400.00
Monthly Payment:    Total Monthly Payment therafter:    2,700.00

 

Service Provision:    Start Date    1 November 2011    End Date    31 October 2012

All agreements end on the last calendar day of the month.

Comments: Terms and conditions have been read, understood and accepted. Payment is required in advance no later than 25th of each month. Late payment of invoices will incur a penalty fee. It has been agreed that months 1, 4, 7 & 10 will be rent free (this does not include services). All chargeable rental months are at 2700 per month (not including services). Monthly recurring fees at this stage are: 368. This breaks down as: 2 x RegusNet Broadband Bundle@ 129. Client has decided not to take phone line at this stage. 1 x beverage package @ 39. It has been agreed that the client can take one parking space for 200 per month. One off set up fees: 2 x months deposit has been agreed. 49 per person for keys, fobs and security settings. 1 x 129 for RegusNet Broadband Bundle connections Client is aware of the exit charges highlighted in Section 8 and wants the choice at the end of the contract to whether avail of the Business Continuity Package. Complimentary Businessworld Gold Card allowing access to all 1100 Business Lounges globally. All prices are subject to 21% VAT

 

Page 1


1. This Agreement

1.1 Nature of this agreement: This agreement is the commercial equivalent of an agreement for accommodation(s) in a hotel. The whole of the Center remains in Regus’ possession and control. THE CLIENT ACCEPTS THAT THIS AGREEMENT CREATES NO TENANCY INTEREST, LEASEHOLD ESTATE OR OTHER REAL PROPERTY INTEREST IN THE CLIENT’S FAVOUR WITH RESPECT TO THE ACCOMMODATION(S). Regus is giving the Client the right to share with Regus the use of the Center on these terms and conditions, as supplemented by the House Rules, so that Regus can provide the services to the Client. This agreement is personal to the Client and cannot be transferred to anyone else. This agreement is composed of the front page describing the accommodation(s), the present terms and conditions and the House Rules.

1.2 Comply with House Rules: The Client must comply with any House Rules which Regus imposes generally on users of the Center. The House Rules vary from country to country and from Center to Center and these can be requested locally.

1.3 Duration: This agreement lasts for the period stated in it and then will be extended automatically for successive periods equal to the current term but no less than 3 months (unless legal renewal term limits apply) until brought to an end by the Client or by Regus. All periods shall run to the last day of the month in which they would otherwise expire. The fees on any renewal will be at the then prevailing market rate.

1.4 Bringing this agreement to an end: Either Regus or the Client can terminate this agreement at the end date stated in it, or at the end of any extension or renewal period, by giving at least three months written notice to the other. However, if this agreement, extension or renewal is for three months or less and either Regus or the Client wishes to terminate it, the notice period is two months or (if two months or shorter) one week less than the period stated in this agreement.

1.5 Ending this agreement immediately: To the maximum extent permitted by applicable law, Regus may put an end to this agreement immediately by giving the Client notice and without need to follow any additional procedure if (a) the Client becomes insolvent, bankrupt, goes into liquidation or becomes unable to pay its debts as they fall due, or (b) the Client is in breach of one of its obligations which cannot be put right or which Regus have given the Client notice to put right and which the Client has failed to put right within fourteen (14) days of that notice, or (c) its conduct, or that of someone at the Center with its permission or invitation, is incompatible with ordinary office use.

If Regus puts an end to this agreement for any of these reasons it does not put an end to any outstanding obligations, including additional services used and the monthly office fee for the remainder of the period for which this agreement would have lasted if Regus had not ended it.

1.6 If the Center is no longer available: In the event that Regus is permanently unable to provide the services and accommodation(s) at the Center stated in this agreement then this agreement will end and the Client will only have to pay monthly office fees up to the date it ends and for the additional services the Client has used. Regus will try to find suitable alternative accommodation(s) for the Client at another Regus Center.

1.7 When this agreement ends the Client is to vacate the accommodation(s) immediately, leaving the accommodation(s) in the same condition as it was when the Client took it. Upon the Client’s departure or if the Client, at its option, chooses to relocate to different rooms within the Centre, Regus will charge an Office Restoration Service fee to cover normal cleaning and testing and to return the accommodation(s) to its original state. This fee will differ by country and is listed in the House Rules. Regus reserves the right to charge additional reasonable fees for any repairs needed above and beyond normal wear and tear. If the Client leaves any property in the Centre Regus may dispose of it at the Client’s cost in any way Regus chooses without owing the Client any responsibility for it or any proceeds of sale. When a Client vacates its accommodation(s) invariably Regus continues to receive the Client’s mail, faxes, telephone calls and visitors. In order to professionally manage the redirection of the Client’s calls, mail, faxes and visitors Regus charges a one-time Business Continuity Service. This service lasts for three months after the end of the date of this agreement. If in the event that there are no calls, mail, faxes or visitors this service will not be applied. This fee is located in the house rules.

If the Client continues to use the accommodation(s) when this agreement has ended the Client is responsible for any loss, claim or liability Regus incurs as a result of the Client’s failure to vacate on time. Regus may, at its discretion, permit the Client an extension subject to a surcharge on the monthly office fee.

1.8 Employees: While this agreement is in force and for a period of six months after it ends, neither Regus nor the Client may knowingly solicit or offer employment to any of the other’s staff employed in the Center. This obligation applies to any employee employed at the Center up to that employee’s termination of employment, and for three months thereafter. It is stipulated that the breaching party shall pay the non-breaching party the equivalent of one year’s salary for any employee concerned. Nothing in this clause shall prevent either party from employing an individual who responds in good faith and independently to an advertisement which is made to the public at large.

1.9 Client Representation of Regus Employees: Throughout the duration of this agreement, Client agrees that neither Client, nor any of Client’s partners, members, officers or employees will represent, or otherwise provide legal counsel to, any of Regus’ current or former employees in any dispute with, or legal proceeding against, Regus, or any of Regus’ affiliates, members, officers or employees.

1.10 Notices: All formal notices must be in writing to the address first written above.

1.11 Confidentiality: The terms of this agreement are confidential. Neither Regus nor the Client must disclose them without the other’s consent unless required to do so by law or an official authority. This obligation continues after this agreement ends.

1.12 Applicable law: This agreement is interpreted and enforced in accordance with the law of the place where the relevant Centre is located. Regus and the Client both accept the exclusive jurisdiction of the courts of such jurisdiction. If any provision of these terms and conditions is held void or unenforceable under the applicable law, the other provisions shall remain in force. In the case of Japan all arrangements will interpreted and enforced by the Tokyo District Court, and in the case of France, any dispute regarding this agreement will be settled by the relevant courts of the Paris jurisdiction.

1.13 Enforcing this agreement: The Client must pay any reasonable and proper costs including legal fees that Regus incurs in enforcing this agreement.

2. Services and Obligations

2.1 Furnished office accommodation(s): Regus is to provide the number of serviced and furnished office accommodation(s) for which the Client has agreed to pay in the Center stated in this agreement. This agreement lists the accommodation(s) Regus has initially allocated for the Client’s use. The Client will have a non-exclusive right to the rooms allocated to it. Occasionally Regus may need to allocate different accommodation(s), but these accommodation(s) will be of reasonably equivalent size and Regus will notify the Client with respect to such different accommodation(s) in advance.

2.2 Office Services: Regus is to provide during normal opening hours the services, if requested, described in the relevant service description (which is available on request). If Regus decides that a request for any particular service is excessive, it reserves the right to charge an additional fee.

2.3 RegusNET: REGUS DOES NOT MAKE ANY REPRESENTATIONS AS TO THE SECURITY OF REGUS’ NETWORK (OR THE INTERNET) OR OF ANY INFORMATION THAT THE CLIENT PLACES ON IT. The Client should adopt whatever security measures (such as encryption) it believes are appropriate to its circumstances. Regus cannot guarantee that a particular degree of availability will be attained in connection with the Client’s use of Regus’ network (or the internet). The Client’s sole and exclusive remedy shall be the remedy of such failure by Regus within a reasonable time after written notice.

3. Providing the Services

3.1 Access to the accommodation(s): Regus may need to enter the Client’s accommodation(s) and may do so at any time. However, unless there is an emergency or the Client has given notice to terminate, Regus will attempt to notify the Client verbally or electronically in advance when Regus needs access to carry out testing, repair or works other than routine inspection, cleaning and maintenance. Regus will also endeavor to respect reasonable security procedures to protect the confidentiality of the Client’s business.

3.2 Availability at the start of this agreement: If for any reason Regus cannot provide the accommodation(s) stated in this agreement by the date when this agreement is due to start it has no liability to the Client for any loss or damages but the Client may cancel this agreement without penalty. Regus will not charge the Client the monthly office fee for accommodation(s) the Client cannot use until it becomes available. Regus may delay the start date of this agreement provided it provides to the Client alternative accommodation(s) that shall be at least of equivalent size to the accommodation(s) stated in this agreement.

4. Accommodation(s)

4.1 The Client must not alter any part of its accommodation and must take good care of all parts of the Center, its equipment, fixtures, fittings and furnishings which the Client uses. The Client is liable for any damage caused by it or those in the Center with the Client’s permission or at the Client’s invitation whether express or implied, including but not limited to all employees, contractors, agents or other persons present on the premises.

4.2 Office furniture and equipment: The Client must not install any cabling, IT or telecom connections without Regus’ consent, which Regus may refuse at its absolute discretion. As a condition to Regus’ consent, the Client must permit Regus to oversee any installations (for example IT or electrical systems) and to verify that such installations do not interfere with the use of the accommodation(s) by other Clients or Regus or any landlord of the building.

4.3 Insurance: It is the Client’s responsibility to arrange insurance for its own property which it brings in to the Center and for its own liability to its employees and to third parties. Regus strongly recommends that the Client put such insurance in place.

5. Use

5.1 The Client must only use the accommodation(s) for office purposes. Office use of a “retail” or “medical” nature, involving frequent visits by members of the public, is not permitted.

5.2 The Client must not carry on a business that competes with Regus’ business of providing services office accommodation(s).

5.3 The Client’s name and address: The Client may only carry on that business in its name or some other name that Regus previously agrees.

5.4 Use of the Center Address: The Client may use the Center address as its business address. Any other uses are prohibited without Regus’ prior written consent.

6. Compliance

6. 1 Comply with the law: The Client must comply with all relevant laws and regulations in the conduct of its business. The Client must do nothing illegal in connection with its use of the Business Center. The Client must not do anything that may interfere with the use of the Center by Regus or by others, cause any nuisance or annoyance, increase the insurance premiums Regus has to pay, or cause loss or damage to Regus (including damage to reputation) or to the owner of any interest in the building which contains the Center the Client is using. The Client acknowledges that (a) the terms of the foregoing sentence are a material inducement in Regus’ execution of this agreement and (b) any violation by the Client of the foregoing sentence shall constitute a material default by the Client hereunder, entitling Regus to terminate this agreement, without further notice or procedure.

6.2 The Client’s personal data may be transferred outside the European Union where Regus has a Center for the purposes of providing the services herein. Regus has adopted internal rules to ensure data protection in accordance with European regulations.

7. Regus’ Liability

7.1 The extent of Regus’ liability: To the maximum extent permitted by applicable law, Regus is not liable to the Client in respect of any loss or damage the Client suffers in connection with this agreement, with the services or with the Client’s accommodation(s) unless Regus has acted deliberately or negligently in causing that loss or damage. Regus is not liable for any loss as a result of Regus’ failure to provide a service as a result of mechanical breakdown, strike, termination of Regus’ interest in the building containing the Center or otherwise unless Regus does so deliberately or is negligent. In no event shall Regus be liable for any loss or damage until the Client provides Regus written notice and gives Regus a reasonable time to put it right. If Regus is liable for failing to provide the Client with any service under this agreement then subject to the exclusions and limits set out immediately below Regus will pay any actual and reasonable expenses the Client has incurred in obtaining that service from an alternative source. If the Client believes Regus has failed to deliver a service consistent with these terms and conditions the Client shall provide Regus written notice of such failure and give Regus a reasonable period to put it right.

7.2. EXCLUSION OF CONSEQUENTIAL LOSSES, ETC.: REGUS WILL NOT IN ANY CIRCUMSTANCES HAVE ANY LIABILITY FOR LOSS OF BUSINESS, LOSS OF PROFITS, LOSS OF ANTICIPATED SAVINGS, LOSS OF OR DAMAGE TO DATA, THIRD PARTY CLAIMS OR ANY CONSEQUENTIAL LOSS UNLESS REGUS OTHERWISE AGREES IN WRITING. REGUS STRONGLY ADVISES THE CLIENT TO INSURE AGAINST ALL SUCH POTENTIAL LOSS, DAMAGE, EXPENSE OR LIABILITY.

7.3. Financial limits to Regus’ liability: In all cases, Regus’ liability to the Client is subject to the following limits:

 

 

Without limit for personal injury or death;

 

 

Up to a maximum of £1 million / USD$2 million / €1.3 million (or local equivalent) for any one event or series of connected events for damage to the Client’s personal property except in Turkey where it will be up to a maximum of the monthly office fee over the current term;

 

 

Up to a maximum equal to 125% of the total fees paid between the date the Client moved into its accommodation(s) and the date on which the claim in question arises or £50,000 / USD$100,000 / €66,000 (or local equivalent) whichever is the higher, in respect of any other loss or damage except in Turkey where it will be up to a maximum of the monthly office fee over the current term.

8. Fees

8.1 Taxes and duty charges: The Client agrees to pay promptly (i) all sales, use, excise, consumption and any other taxes and license fees which it is required to pay to any governmental authority (and, at Regus’ request, will provide to Regus evidence of such payment) and (ii) any taxes paid by Regus to any governmental authority that are attributable to the accommodation(s), including, without limitation, any gross receipts, rent and occupancy taxes, tangible personal property taxes, stamp tax or other documentary taxes and fees.

8.2 Service Retainer/Deposit: The Client will be required to pay a service retainer/deposit equivalent to two months’ of the monthly office fee (plus VAT/Tax where applicable) upon entering into this agreement unless a greater amount is specified on the front of this agreement. This will be held by Regus without generating interest as security for performance of all the Client’s obligations under this agreement. The service retainer/deposit or any balance after deducting outstanding fees, the Business Continuity and Office Restoration Service and other costs due to Regus, will be returned to the Client after the Client has settled its account with Regus and funds have been cleared.

8.3 Regus may require the Client to pay an increased retainer if outstanding fees exceed the service retainer/deposit held and/or the Client frequently fails to pay Regus when due.

8.4 The Client will be charged an office set up fee per occupant. Fee amounts are located in the House Rules which can be requested at anytime.

8.5 Late Payment: If the Client does not pay fees when due, a fee will be charged on all overdue balances. This will differ by country and is listed in the House Rules. If the Client disputes any part of an invoice the Client must pay the amount not in dispute by the due date or be subject to late fees. Regus also reserves the right to withhold services (including for the avoidance of doubt, denying the Client access to its accommodations(s)) while there are any outstanding fees and/or interest or the Client is in breach of this agreement.

8.6 Payment : Regus is continually striving to reduce its environmental impact and supports its clients in doing the same. Therefore Regus will send all invoices electronically (where allowed by law) and the Client will make payments via an automated method such as Direct Debit or Credit Card, wherever local banking systems permit.

8.7 Insufficient Funds: The Client will pay a fee for any returned check or any other declined payments due to insufficient funds. This fee will differ by country and is listed in the House Rules.

8.8. Regus will increase the monthly office fee each and every anniversary of the start date of this agreement by a percentage amount equal to the increase in the All Items Retail Prices Index, or such other broadly equivalent Index which Regus substitutes provided that if the foregoing increase is not permitted by applicable law, then the monthly office fee shall be increased as specified in the House Rules. This will only apply to agreements that have an original start and end date constituting more than a 12 month term. Renewals will be renewed as per clause 1.3 above and only those renewals with a start and end date constituting a term of over 12 months will have the same increase applied.

8.9 Standard services: The monthly office fee and any recurring services requested by the Client are payable monthly in advance. Unless otherwise agreed in writing, these recurring services will be provided by Regus at the specified rates for the duration of this Agreement (including any renewal). Specific due dates will differ by country and are listed in the House rules. Where a daily rate applies, the charge for any such month will be 30 times the daily fee. For a period of less than a month the fee will be applied on a daily basis.

8.10 Pay-as-you-use and additional Variable Services: Fees for pay-as-you-use services, plus applicable taxes, in accordance with Regus’ published rates which may change from time to time, are invoiced in arrears and payable the month following the calendar month in which the additional services were provided. Specific due dates will differ by country and are listed in the House Rules.

8.11 Discounts, Promotions and Offers: If the Client benefited from a special discount, promotion or offer, Regus may discontinue that discount, promotion or offer without notice if the Client breaches these terms and conditions or becomes past due on two or more occasions.

Global – Terms & Conditions – June 2011 – Iveber

 

Exhibit 31.1

CERTIFICATION

I, Joseph Zakrzewski, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of Amarin Corporation plc;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: November 8, 2011  

/s/    Joseph Zakrzewski        

  Joseph Zakrzewski
 

Chief Executive Officer

(Principal Executive Officer)

Exhibit 31.2

CERTIFICATION

I, John F. Thero, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of Amarin Corporation plc;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: November 8, 2011  

/s/    John F. Thero        

  John F. Thero
  President (Principal Financial Officer)

Exhibit 32.1

STATEMENT PURSUANT TO 18 U.S.C. § 1350

Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Joseph Zakrzweski, Chief Executive Officer (Principal Executive Officer) of Amarin Corporation plc, and John F. Thero, President (Principal Financial Officer) of the Company, each hereby certifies that, to the best of his knowledge:

 

(1) The Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2011, to which this Certification is attached as Exhibit 32.1 (the “Quarterly Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Exchange Act; and

 

(2) The information contained in the Quarterly Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

  

/s/ Joseph Zakrzewski

Date: November 8, 2011    Joseph Zakrzweski
   Chief Executive Officer (Principal Executive Officer)
  

/s/ John F. Thero

Date: November 8, 2011    John F. Thero
   President (Principal Financial Officer)

This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not incorporated by reference into any filing of Amarin Corporation plc under the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.