UNITED
STATES SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Form
20−F
o |
REGISTRATION
STATEMENT PURSUANT TO SECTION 12(b) OR 12(g) OF THE SECURITIES EXCHANGE
ACT OF 1934
|
OR
x
|
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934 FOR THE FISCAL YEAR ENDED DECEMBER 31,
2008
|
OR
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934 FOR THE TRANSITION PERIOD FROM
TO
|
OR
o
|
SHELL
COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934 DATE OF EVENT REQUIRING THIS SHELL COMPANY
REPORT
|
Commission
file number 0−21392
AMARIN
CORPORATION PLC
(Exact
Name of Registrant as Specified in Its Charter)
England
and Wales
(Jurisdiction
of Incorporation or Organization)
First
Floor, Block 3, The Oval
Shelbourne
Road, Ballsbridge
Dublin 4,
Ireland
(Address
of Principal Executive Offices)
SECURITIES
REGISTERED OR TO BE REGISTERED PURSUANT TO SECTION 12(b) OF THE
ACT:
|
|
Name
of Each Exchange
on
Which Registered
|
None
|
|
None
|
SECURITIES
REGISTERED OR TO BE REGISTERED PURSUANT TO SECTION 12(g) OF THE
ACT:
American
Depositary Shares, each representing one Ordinary Share
Ordinary
Shares, 50 pence par value per share
(Title of
Class)
SECURITIES
FOR WHICH THERE IS A REPORTING OBLIGATION PURSUANT TO SECTION 15(d) OF THE
ACT:
None.
Indicate
the number of outstanding shares of each of the issuer’s classes of capital or
common stock as of the close of the period covered by the annual
report.
27,046,716
Ordinary Shares, 50 pence par value per share
Indicate
by check mark if the registrant is a well−known seasoned issuer, as defined in
Rule 405 of the Securities Act.
YES o NO
x
If this
report is an annual or transition report, indicate by check mark if the
registrant is not required to file reports pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934.
YES o NO
x
Note —
Checking the box above will not relieve any registrant required to file reports
pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 from
their obligations under those Sections.
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
o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of “accelerated
filer and large accelerated filer” in Rule 12b−2 of the Exchange Act. (Check
one):
Large
accelerated filer o
Accelerated filer o
Non-accelerated filer x
Indicate
by check mark which basis of accounting the registrant has used to prepare the
financial statements included in this filing:
U.S. GAAP
o
International
Financial Reporting Standards as issued by the International Accounting
Standards Board x
Indicate
by check mark which financial statement item the registrant has elected to
follow.
ITEM
17 o ITEM 18
x
If this
is an annual report, indicate by check mark whether the registrant is a shell
company (as defined in Rule 12b−2 of the Exchange Act).
YES o NO
x
TABLE
OF CONTENTS
|
Page |
|
|
INTRODUCTION
|
1
|
CAUTIONARY
NOTE REGARDING FORWARD−LOOKING STATEMENTS
|
2
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PART
I
Item
1
|
Identity
of Directors, Senior Management and Advisers
|
3
|
Item
2
|
Offer
Statistics and Expected Timetable
|
3
|
Item
3
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Key
Information
|
3
|
Item
4
|
Information
on the Company
|
20
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Item
4A
|
Unresolved
Staff Comments
|
30
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Item
5
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Operating
and Financial Review and Prospects
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30
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Item
6
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Directors,
Senior Management and Employees
|
44
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Item
7
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Major
Shareholders and Related Party Transactions
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54
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Item
8
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Financial
Information
|
57
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Item
9
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The
Offer and Listing
|
60
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Item
10
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Additional
Information
|
62
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Item
11
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Quantitative
and Qualitative Disclosures About Market Risk
|
82
|
Item
12
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Description
of Securities Other than Equity Securities
|
82
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PART
II
Item
13
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Defaults,
Dividend Arrearages and Delinquencies
|
82
|
Item
14
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Material
Modifications to the Rights of Security Holders and Use of
Proceeds
|
82
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Item
15
|
Controls
and Procedures
|
83
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Item
15T |
Controls
and Procedures |
83 |
Item
16
|
[Reserved]
|
84
|
Item
16A
|
Audit
Committee Financial Expert
|
84
|
Item
16B
|
Code
of Ethics
|
84
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Item
16C
|
Principal
Accountant Fees and Services
|
84
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Item
16D
|
Exemptions
from the Listing Standards for Audit Committees
|
84
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Item
16E
|
Purchases
of Equity Securities by the Issuer and Affiliated
Purchasers
|
84
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Item
16F
|
Change
in Registrants Certified Accountant
|
85
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Item
16G
|
Corporate
Governance
|
85
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PART
III
Item
17
|
Financial
Statements
|
85
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Item
18
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Financial
Statements
|
85
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Item
19
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Exhibits
|
85
|
|
|
|
SIGNATURES |
|
93 |
|
|
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INTRODUCTION
This
report comprises the annual report to shareholders of Amarin Corporation plc
(NASDAQCM: AMRN) and its annual report on Form 20-F in accordance with the
requirements of the United States Securities and Exchange Commission, or SEC,
for the year ended December 31, 2008.
As used
in this annual report, unless the context otherwise indicates, the terms
“Group”, “Amarin”, “we”, “us” and “our” refer to Amarin Corporation plc and its
wholly owned subsidiary companies. Also, as used in this annual report, unless
the context otherwise indicates, the term “Company” refers to Amarin Corporation
plc, the parent company of the Group. Laxdale Limited, a company which we
acquired in October 2004 and is now known as Amarin Neuroscience Limited, may be
referred to herein as “Amarin Neuroscience” or “Laxdale.” Ester Neurosciences
Limited, a company which we acquired in December 2007 may be referred to herein
as “Ester Neurosciences” or “Ester”.
Also, as
used in this annual report, unless the context otherwise indicates, the term
“Ordinary Shares” refers to our Ordinary Shares, par value 50 pence per share,
the term “Preference Shares” refers to our authorized preference shares, par
value 5 pence per share and the term “Series A Preference Shares” refers to our
Series A Preference Shares, par value 50 pence per share. Unless otherwise
specified, all shares and share related information (such as per share
information and share price information) in this annual report have been
adjusted to give effect, retroactively, to our one-for-ten Ordinary Share
consolidation effective on July 17, 2002 whereby ten Ordinary Shares of 10 pence
each became one Ordinary Share of £1.00 each, to the subsequent sub-division and
conversion of each issued and outstanding Ordinary Share of £1.00 each on June
21, 2004 into one Ordinary Share of 5 pence and one deferred share of 95 pence
(and the subsequent purchase by the Company and cancellation of all such
deferred shares) and each of the authorized but unissued Ordinary Shares of £1
each in the capital of the Company into 20 Ordinary Shares of 5 pence each and
to our one-for-ten Ordinary Share consolidation effective on January 18, 2008
whereby ten Ordinary Shares of 5 pence each became one Ordinary Share of 50
pence each.
In
addition, as used in this annual report, the term “Debentures” refers to our 8%
Convertible Debentures due 2010 which were issued on December 6, 2007 in
connection with the financing of our acquisition of Ester. These
debentures were redeemed in full in May 2008.
On
October 13, 2009, Amarin announced it had entered into definitive agreements
with several existing and new institutional and accredited investors for a
private placement of units for $70 million, consisting of $66.4 million in cash
proceeds and $3.6 million from the conversion of convertible bridge notes. On
closing of the private placement, in consideration for the $66.4 million
received in cash, Amarin issued 66.4 million units. Each unit had a purchase
price of $1.00 and consisted of one American Depositary Share (“ADS”) and a
warrant to purchase 0.50 of an ADS. The warrants will have a five year term and
an exercise price of $1.50 per ADS. In consideration for the conversion of $3.6
million of convertible bridge notes, Amarin issued 4.0 million units. In
accordance with the terms of the conversion of the bridge notes, each unit had a
purchase price of $0.90 and consisted of one ADS and a warrant to purchase 0.50
of an ADS. The warrants will also have a five year term and an exercise price of
$1.50 per ADS.
See Item
8B “Significant changes” for further information.
In this
annual report, references to “pounds sterling,” “£” or “GBP£” are to U.K.
currency, references to “U.S. Dollars”, “$” or “US$” are to U.S. currency,
references to “euro” or “€” are to Euro currency and references to “New Israeli
Shekel”, “NIS” or “shekel” are to Israeli currency.
This
annual report contains trademarks, tradenames or registered marks owned by
Amarin or by other entities, including:
|
·
|
Nanocrystal®,
which during the fiscal year covered by this report was registered in Elan
Corporation plc or its affiliates, which we may refer to in this annual
report as “Elan”.
|
|
·
|
Permax®,
which during the fiscal year covered by this report was registered in Eli
Lilly and Company or its affiliates, which we may refer to in this annual
report as “Lilly”.
|
CAUTIONARY
NOTE REGARDING FORWARD−LOOKING STATEMENTS
This
annual report contains forward-looking statements about our financial condition,
results of operations, business prospects and products in research and involve
substantial risks and uncertainties. You can identify these statements by the
fact that they use words such as “will”, “anticipate”, “estimate”, “project”,
“forecast”, “intend”, “plan”, “believe” and other words and terms of similar
meaning in connection with any discussion of future operating or financial
performance or events. Among the factors that could cause actual results to
differ materially from those described or projected herein are the
following;
|
·
|
The
success of our research and development
activities;
|
|
·
|
Decisions
by regulatory authorities regarding whether and when to approve our drug
applications, as well as their decisions regarding labeling and other
matters that could affect the commercial potential of our
products;
|
|
·
|
The
speed with which regulatory authorizations, pricing approvals and product
launches may be achieved;
|
|
·
|
The
success with which developed products may be
commercialized;
|
|
·
|
Competitive
developments affecting our products under
development;
|
|
·
|
The
effect of possible domestic and foreign legislation or regulatory action
affecting, among other things, pharmaceutical pricing and reimbursement,
including under Medicaid and Medicare in the United States, and
involuntary approval of prescription medicines for over-the-counter
use;
|
|
·
|
Claims
and concerns that may arise regarding the safety or efficacy of our
product candidates;
|
|
·
|
Governmental
laws and regulations affecting our operations, including those affecting
taxation;
|
|
·
|
Our
ability to maintain sufficient cash and other liquid resources to meet
operating requirements and debt service
requirements;
|
|
·
|
General
changes in International Financial Reporting Standards (“IFRS”) as adopted
by the European Union (“E.U.”) and as issued by the International
Accounting Standards Board
(“IASB”);
|
|
·
|
Patent
positions can be highly uncertain and patent disputes are not unusual. An
adverse result in a patent dispute can hamper commercialization of
products or negatively impact sales of future products or result in
injunctive relief and payment of financial
remedies;
|
|
·
|
Uncertainties
of the U.S. Food and Drug Administration (“FDA”) approval process and the
regulatory approval processes in other countries, including, without
limitation, delays in approval of new
products;
|
|
·
|
Difficulties
in product development. Pharmaceutical product development is highly
uncertain. Products that appear promising in development may fail to reach
market for numerous reasons. They may be found to be ineffective or to
have harmful side effects in clinical or pre-clinical testing, they may
fail to receive the necessary regulatory approvals, they may turn out not
to be economically feasible because of manufacturing costs or other
factors or they may be precluded from commercialization by the proprietary
rights of others;
|
|
·
|
Growth
in costs and expenses; and
|
|
·
|
The
impact of acquisitions, divestitures and other unusual
items.
|
PART
I
Item
1 Identity
of Directors, Senior Management and Advisers
Not
applicable.
Item
2 Offer
Statistics and Expected Timetable
Not
applicable.
A. Selected
Financial Data
General
The
following table presents selected historical consolidated financial
data. The selected historical consolidated financial data as of
December 31, 2008, 2007 and 2006 and for each of the years ended December 31,
2008, 2007 and 2006 have been derived from our audited consolidated financial
statements beginning on page F-1 of this annual report, prepared in accordance
with IFRS as adopted by the E.U. and as issued by the IASB, which have been
audited by PricewaterhouseCoopers, an independent registered public accountant
firm, for the years ended December 31, 2008, 2007 and 2006.
The
selected historical consolidated financial data as of December 31, 2004 and 2005
and for the years then ended has been derived from our audited historical
financial statements prepared in accordance with generally accepted accounting
principles in the United Kingdom (“U.K. GAAP”) which are not included in these
financial statements.
Unless
otherwise specified, all references in this annual report to “fiscal year” or
“year” of Amarin refer to a twelve-month financial period ended December
31. We prepare our consolidated financial statements in accordance
with IFRS as adopted by the E.U. and as issued by the IASB.
We
adopted IFRS for the first time for our financial year ended December 31,
2007. Our audited Consolidated Financial Statements as of and for the
year ended December 31, 2006 were originally prepared in accordance with U.K.
GAAP. As part of our adoption of IFRS, we have restated our
Consolidated Financial Statements in accordance with IFRS for comparative
purposes.
During
2002 our Ordinary Shares were consolidated on a ten-for-one basis. Concurrently,
we amended the terms of our American Depositary Shares, or ADSs, to provide that
each ADS would represent one Ordinary Share. Previously each ADS had represented
ten Ordinary Shares of 10 pence each. In June 2004 we converted each
of our £1 Ordinary Shares into one Ordinary Share of 5 pence and one deferred
share of 95 pence (with such deferred shares having been subsequently
cancelled). This share conversion in 2004 did not affect the ratio as
between our Ordinary Shares and our ADSs but is recorded below in the year 2004.
On January 18, 2008 our Ordinary Shares were consolidated on a one-for-ten basis
whereby ten Ordinary Shares of 5 pence each became one Ordinary Share of 50
pence each. The new conversion ratio has been reflected in all years in the
weighted average share numbers shown in the consolidated statement of operations
data below.
On
October 13, 2009, Amarin announced it had entered into definitive agreements
with several existing and new institutional and accredited investors for a
private placement of units for $70 million, consisting of $66.4 million in cash
proceeds and $3.6 million from the conversion of convertible bridge notes. On
closing of the private placement, in consideration for the $66.4 million
received in cash, Amarin issued 66.4 million units. Each unit had a purchase
price of $1.00 and consisted of one American Depositary Share (“ADS”) and a
warrant to purchase 0.50 of an ADS. The warrants will have a five year term and
an exercise price of $1.50 per ADS. In consideration for the conversion of $3.6
million of convertible bridge notes, Amarin issued 4.0 million units. In
accordance with the terms of the conversion of the bridge notes, each unit had a
purchase price of $0.90 and consisted of one ADS and a warrant to purchase 0.50
of an ADS. The warrants will also have a five year term and an exercise price of
$1.50 per ADS.
See Item
8B “Significant changes” for further information.
Selected
Consolidated Financial Data — IFRS
|
|
|
|
|
|
|
|
|
|
|
|
(In
U.S. $, thousands except per share
data
and number of shares information)
|
|
Statement
of Operation Data — IFRS
|
|
|
|
|
|
|
|
|
|
Net
sales revenues
|
|
|
— |
|
|
|
— |
|
|
|
500 |
|
Total
loss from operations
|
|
|
(28,180 |
) |
|
|
(40,733 |
) |
|
|
(28,068 |
) |
Net
loss
|
|
|
(20,021 |
) |
|
|
(37,800 |
) |
|
|
(26,751 |
) |
Net
loss per Ordinary Share – basic*
|
|
|
(0.91 |
) |
|
|
(3.86 |
) |
|
|
(3.25 |
) |
Net
loss per Ordinary Share – diluted*
|
|
|
(0.91 |
) |
|
|
(3.86 |
) |
|
|
(3.25 |
) |
Consolidated
balance sheet data — amounts in accordance with IFRS
|
|
|
|
|
|
|
|
|
|
|
|
|
Working
capital assets
|
|
|
10,069 |
|
|
|
11,072 |
|
|
|
28,710 |
|
Total
assets
|
|
|
36,657 |
|
|
|
42,254 |
|
|
|
49,559 |
|
Long
term obligations
|
|
|
(651 |
) |
|
|
(4,801 |
) |
|
|
(110 |
) |
Capital
stock (ordinary shares)
|
|
|
25,928 |
|
|
|
12,942 |
|
|
|
7,990 |
|
Total
shareholders’ equity
|
|
|
28,898 |
|
|
|
26,797 |
|
|
|
38,568 |
|
Number
of ordinary share in issue (thousands)*
|
|
|
27,047 |
|
|
|
13,906 |
|
|
|
9,068 |
|
Denomination
of each ordinary share*
|
|
|
£0.50 |
|
|
|
£0.50 |
|
|
|
£0.50 |
|
(1)
|
see
our annual report on Form 20-F/A filed with the SEC on September 24, 2008
for information on our restatement.
|
*
|
On
January 18, 2008, our Ordinary Shares were consolidated on a one-for-ten
basis whereby ten Ordinary Shares of 5p each became one Ordinary Share of
50p. Shares and share information above have been adjusted to
reflect this share consolidation.
|
Selected
Consolidated Financial — U.K. GAAP
|
|
Years
Ended December
|
|
|
|
|
|
|
|
|
|
|
(In
U.S. $, thousands except per share
data
and number of shares information)
|
|
Statement
of Operations Data — U.K. GAAP
|
|
|
|
|
|
|
Net
sales revenues
|
|
|
1,017 |
|
|
|
500 |
|
Total
loss from operations
|
|
|
(11,875 |
) |
|
|
(20,478 |
) |
Loss
from continuing operations
|
|
|
(10,608 |
) |
|
|
(20,478 |
) |
Net
income/(loss)
|
|
|
3,229 |
|
|
|
(20,547 |
) |
Loss
from continuing operations per Ordinary Share*
|
|
|
(4.71 |
) |
|
|
(4.45 |
) |
Net
income/(loss) per Ordinary Share – basic*
|
|
|
1.43 |
|
|
|
(4.41 |
) |
Net
income/(loss) per Ordinary Share – diluted*
|
|
|
1.43 |
|
|
|
(4.41 |
) |
Consolidated
balance sheet data — amounts in accordance with U.K. GAAP
|
|
|
|
|
|
|
|
|
Working
capital assets
|
|
|
8,651 |
|
|
|
28,673 |
|
Total
assets
|
|
|
23,721 |
|
|
|
46,760 |
|
Long
term obligations
|
|
|
(2,687 |
) |
|
|
(180 |
) |
Capital
stock (ordinary shares)
|
|
|
3,206 |
|
|
|
6,778 |
|
Total
shareholders’ equity
|
|
|
16,693 |
|
|
|
38,580 |
|
Number
of ordinary shares in issue (thousands)*
|
|
|
3,763 |
|
|
|
7,755 |
|
Denominations
of each ordinary share*
|
|
|
£0.50 |
|
|
|
£0.50 |
|
For
previously reported 2006 financial information prepared under U.K. GAAP please
see our 2006 Annual Report on Form 20-F filed with the SEC on March 5,
2007.
*
|
On
January 18, 2008, our Ordinary Shares were consolidated on a one-for-ten
basis whereby ten Ordinary Shares of 5p each became one Ordinary Share of
50p. Shares and share information above has been adjusted to
reflect this share consolidation.
|
**
|
As
restated for the non-cash compensation expense due to the adoption of U.K.
GAAP, Financial Reporting Standard 20 “Share-based
payments”.
|
We
changed our functional currency on January 1, 2003 from pounds sterling to U.S.
Dollars to reflect the fact that the majority of our transactions, assets and
liabilities were denominated in that currency. Consequently, all data
provided in this annual report is in U.S. Dollars from 2003.
As some
of our assets, liabilities and transactions are denominated in pounds sterling
and euro, the rate of exchange between pounds sterling and the U.S. Dollar and
between euro and U.S. Dollar, which is determined by supply and demand in the
foreign exchange markets and affected by numerous factors, continues to impact
our financial results. Fluctuations in the exchange rates between the
U.S. Dollar and pounds sterling and between U.S. Dollar and euro may affect any
earnings or losses reported by us and the book value of our shareholders’ equity
as expressed in U.S. Dollars, and consequently may affect the market price for
our ADSs.
The
following table sets forth, for the periods indicated, the average of the noon
buying rate on the last day of each month during the relevant period as
announced by the Federal Reserve Bank of New York for pounds sterling expressed
in U.S. Dollars per pound sterling:
|
|
Average
Noon
Buying
Rate
(U.S.
Dollars/
pound
sterling)
|
|
|
|
12
months ended December 31, 2004
|
|
1.8356
|
12
months ended December 31, 2005
|
|
1.8204
|
12
months ended December 31, 2006
|
|
1.8434
|
12
months ended December 31, 2007
|
|
2.0073
|
12
months ended December 31, 2008
|
|
1.8546
|
The
following table sets forth, for each of the last six months, the high and low
noon buying rate during each month as announced by the Federal Reserve Board for
pounds sterling expressed in U.S. Dollars per pound
sterling:
|
|
High
Noon
Buying
Rate
(U.S.
Dollars/
pound
sterling)
|
|
Low
Noon
Buying
Rate
(U.S.
Dollars/
pound
sterling)
|
|
|
|
|
|
April
2009
|
|
1.4990
|
|
1.4607
|
May
2009
|
|
1.6160
|
|
1.4881
|
June
2009
|
|
1.6547
|
|
1.5976
|
July
2009
|
|
1.6713
|
|
1.6027
|
August
2009
|
|
1.6977
|
|
1.6212
|
September
2009
|
|
1.6695
|
|
1.5910
|
The
noon buying rate as of October 20, 2009 was 1.6402 U.S. Dollars per pound
sterling.
B. Capitalization
And Indebtedness
Not
applicable.
C. Reasons
For The Offer And Use Of Proceeds
Not
applicable.
D. Risk
Factors
RISK
FACTORS
You
should carefully consider the risks and the information about our business
described below, together with all the other information included in this annual
report. You should not interpret the order in which these
considerations are presented as an indication of their relative importance to
you. The risks and uncertainties described below are not the only
ones that we face. Additional risks and uncertainties not presently
known to us or that we currently believe to be immaterial may also adversely
affect our business. If any of the following risks and uncertainties
develops into actual events, our business, financial condition and results of
operations could be materially and adversely affected. In such an
instance, the trading price of our ADSs and Ordinary Shares could
decline.
We
have a history of losses, and we may not be able to attain profitability in the
foreseeable future.
We have
not been profitable in four of the last five fiscal years. For the
fiscal years ended December 31, 2004 and 2005, we reported profits/(losses)
under U.K. GAAP of approximately $3.2 million and $(20.5) million
respectively. For the fiscal years ended December 31, 2006, 2007 and
2008 we reported losses under IFRS of approximately $26.8 million, $37.8 million
and $20.0 million respectively. Unless and until marketing approval
is obtained from either the U.S. Food and Drug Administration, which we refer to
as the FDA, or European Medicines Evaluation Agency, which we refer to as the
EMEA, for any of our products, or we are otherwise able to acquire rights to
products that have received regulatory approval or are at an advanced stage of
development and can be readily commercialized, we may not be able to generate
sufficient revenues in future periods to enable us to attain
profitability.
We
acquired Amarin Neuroscience (formerly Laxdale Limited) on October 8, 2004 and
Ester Neurosciences Limited on December 5, 2007. We continue to have
limited operations, assets and financial resources. We currently
have no marketable products or other source of revenues other than the Multicell
out-licensing contract described herein. All of our current products
are in the development stage. The development of pharmaceutical
products is a capital intensive business. Therefore, we expect to
incur expenses without corresponding revenues at
least
until we are at an advanced stage of development or are able to obtain
regulatory approval and sell our future products in significant
quantities. This may result in net operating losses until we can
generate an acceptable level of revenues, which we may not be able to
attain. Further, even if we do achieve operating revenues, there can
be no assurance that such revenues will be sufficient to fund continuing
operations. Therefore, we cannot predict with certainty whether we
will ever be able to achieve profitability.
In
addition to advancing our existing development pipeline, we may also acquire
rights to additional products. However, we may not be successful in
doing so. We may need to raise additional capital before we can
acquire any products. There is also a risk that any of our
development stage products we may acquire will not be approved by the FDA or
regulatory authorities in other countries on a timely basis or at
all. The inability to obtain such approvals would adversely affect
our ability to generate revenues.
The
likelihood of success of our business plan must be considered in light of the
problems, expenses, difficulties, complications and delays frequently
encountered in connection with developing and expanding early stage businesses
and the regulatory and competitive environment in which we operate.
The
continued negative economic conditions would likely negatively impact Amarin’s
ability to obtain financing on acceptable terms.
Unfavorable
economic conditions can impact Amarin’s ability to obtain finance on acceptable
terms. While currently these conditions have not impaired our ability to access
credit markets and finance our operations, there can be no assurance that there
will not be a further deterioration in financial markets and confidence in major
economies. We are unable to predict the likely duration and severity of the
current disruption in financial markets and adverse economic conditions in the
US and other countries.
Our
historical financial results do not form an accurate basis for assessing our
current business.
As a
consequence of divestitures in 2004 and our acquisition of Amarin Neuroscience
in October 2004 and Ester Neurosciences Limited in December 2007, our historical
financial results do not form an accurate basis upon which investors should base
an assessment of our business and prospects. We are now focused on
the research, development and commercialization of novel drugs for
cardiovascular disease. Accordingly, our historical financial results
reflect a substantially different business from that currently being
conducted.
We
may have to issue additional equity, leading to shareholder
dilution.
We are
committed to issue equity to the former shareholders of Amarin Neuroscience upon
the successful achievement of specified milestones for the AMR101 development
program (subject to such shareholders’ right to choose cash payment in lieu of
equity). Pursuant to the Amarin Neuroscience share purchase
agreement, further success-related milestones will be payable as
follows:
Upon
receipt of marketing approval in the United States and Europe for the first
indication of any product containing Amarin Neuroscience intellectual property
as secured in the 2004 Laxdale acquisition, we must make an aggregate stock or
cash payment (at the sole option of each of the sellers) of GBP£7.5 million for
each of the two potential market approvals (i.e., GBP£15.0 million
maximum). In addition, upon receipt of a marketing approval in the
United States and Europe for any other product using Amarin Neuroscience
intellectual property as secured in the 2004 Laxdale acquisition or for a
different indication of a previously approved product, we must make an aggregate
stock or cash payment (at the sole option of each of the sellers) of GBP£5.0
million for each of the two potential market approvals (i.e., GBP£10.0 million
maximum). The
exchange rate as of October 20, 2009 was approximately $1.6402 per
GBP£.
In June
2009, Amarin announced that it had amended the Ester Neurosciences Limited
(“Ester”) acquisition agreement entered into in December 2007. The amendments,
which reflect Amarin’s intention to seek a partner for EN101, provide for the
release of Amarin from research and development diligence obligations contained
in the original agreement, with remaining contingent milestones only being
payable from fees and milestones received from any
future partners. As part of the amendment and waiver agreement, Amarin
issued 1,315,789 ordinary shares to the former Ester
shareholders
On
October 13, 2009, Amarin announced it had entered into definitive agreements
with several existing and new institutional and accredited investors for a
private placement of units for $70 million, consisting of $66.4 million in cash
proceeds and $3.6 million from the conversion of convertible bridge notes. On
closing of the private placement, in consideration for the $66.4 million
received in cash, Amarin issued 66.4 million units. Each unit had a purchase
price of $1.00 and consisted of one American Depositary Share (“ADS”) and a
warrant to purchase 0.50 of an ADS. The warrants will have a five year term and
an exercise price of $1.50 per ADS. In consideration for the conversion of $3.6
million of convertible bridge notes, Amarin issued 4.0 million units. In
accordance with the terms of the conversion of the bridge notes, each unit had a
purchase price of $0.90 and consisted of one ADS and a warrant to purchase 0.50
of an ADS. The warrants will also have a five year term and an exercise price of
$1.50 per ADS.
In May
2009, Amarin announced that it entered into definitive agreements for a private
placement of convertible bridge loan notes (“Initial Bridge Financing”) in the
amount of $2.6 million with certain existing investors in the Company, including
a number of current directors of the Company. In July 2009, $0.1 million of the
Bridge Financing was repaid. In August 2009, the date of maturity on the
convertible loans was extended to September 30, 2009. In August 2009,
Amarin announced that it had entered into definitive agreements for a private
placement of additional convertible bridge loan notes (“Additional Bridge
Financing”) in the amount of $3.0 million with certain existing investors in the
Company, including a number of current directors of the Company.
The
Initial Bridge Financing and Additional Bridge Financing consist of convertible
notes and warrants. The aggregate convertible notes are in the principal amount
of $5.5 million, were to mature on September 30, 2009 and pay interest at the
rate of 8% per annum. In September 2009, the date of maturity was extended to
October 16, 2009.
On
October 16, 2009, as described above, the holders of $3.6 million convertible
bridge loan notes converted their principal into units and the accrued interest
was repaid in cash. As a result, the Company issued 3,999,996
Ordinary Shares of £0.50 and warrants to purchase 1,999,996 shares with an
exercise price of $1.50.
On
October 16, 2009, the holders of the remaining $1.9 million convertible bridge
loan notes elected to have their principal and accrued interest repaid in
cash.
On July
31, 2009, the Company issued warrants to purchase 3,111,105 shares with an
exercise price of $1.00. These warrants were issued to the holders of
the convertible bridge loan notes in consideration for their participation in
the Bridge Financing. They are in addition to the warrants that were
issued on conversion of the convertible bridge loan notes described
above.
In
December 2007, we issued $2.75 million in aggregate principal amount of
three-year convertible debt. This debt was repaid in full on May 29, 2008. These
debenture holders received five-year warrants to purchase
0.23 million ADSs at an exercise price of $4.80. If, at any time
prior to December 6, 2009, the Company issues Ordinary Shares, securities
convertible into
ADSs or Ordinary Shares, warrants to purchase ADSs or Ordinary Shares or options
to purchase any of the aforementioned warrants at a price that is less than, or
converts at a price that is less than, $3.66 (“Down-round Price”), then the
exercise price shall be adjusted to equal 130% of the Down-round
Price.
As
at October 20, 2009 we had 41,060,624 warrants outstanding with a weighted
average exercise price of $1.75 per share. As at October 20, 2009, we
also had outstanding employee options to purchase 2,865,183 Ordinary Shares at
an average exercise price of $5.12 per share.
Additionally,
in pursuing our growth strategy, we may either need to issue new equity as
consideration for the acquisition of products, or to otherwise raise additional
capital, in which case equity, debt convertible into equity or debt instruments
may be issued. The creation of new shares may lead to dilution of the
value of the shares held by our current shareholder base.
If
we cannot find additional capital resources, we will have difficulty in
operating as a going concern and growing our business.
At
December 31, 2008, we had a cash balance of approximately $14.2
million. On
October 13, 2009, Amarin announced it had entered into definitive agreements
with several existing and new institutional and accredited investors for a
private placement of units for $70 million, consisting of $66.4 million in cash
proceeds and $3.6 million from the conversion of convertible bridge notes. On
closing of the private placement, in consideration for the $66.4 million
received in cash, Amarin issued 66.4 million units. Each unit had a purchase
price of $1.00 and consisted of one American Depositary Share (“ADS”) and a
warrant to purchase 0.50 of an ADS. The warrants will have a five year term and
an exercise price of $1.50 per ADS. In consideration for the conversion of $3.6
million of convertible bridge notes, Amarin issued 4.0 million units. In
accordance with the terms of the conversion of the bridge notes, each unit had a
purchase price of $0.90 and consisted of one ADS and a warrant to purchase 0.50
of an ADS. The warrants will also have a five year term and an exercise price of
$1.50 per ADS.
Based
upon current business activities, we forecast having sufficient cash to fund
operations for at least a period of 12 months from October
22, 2009.
We may
also require further funds in the future to implement our long-term growth
strategy recruiting clinical, regulatory and other personnel, and to grow our
business. Our ability to execute our business strategy and sustain
our infrastructure at our current level will be impacted by whether or not we
have sufficient funds. Depending on market conditions and our ability
to maintain financial stability, we may not have access to additional funds on
reasonable terms or at all. 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.
We
may be dependent upon the success of a limited range of products.
If
development efforts for our products are not successful for any indications or
if they are not approved by the FDA, or if adequate demand for our products is
not generated, our business will be materially and adversely
affected. Although we intend to bring additional products forward
from our research and development efforts, even if we are successful in doing
so, the range of products we will be able to commercialize may be limited. This
could restrict our ability to respond to adverse business
conditions. If we are not successful in developing any future product
or products, or if there is not adequate demand for any such products or the
market for such product develops less rapidly than we anticipate, we may not
have the ability to shift our resources to the development of alternative
products. As a result, the limited range of products we intend to develop could
constrain our ability to generate revenues and achieve
profitability.
Our
ability to generate revenues depends on obtaining regulatory approvals for our
products.
In order
to successfully commercialize a product, we or our potential partners will be
required to conduct all tests and clinical trials needed in order to meet
regulatory requirements, to obtain applicable regulatory approvals, and to
prosecute patent applications. The costs of developing and obtaining
regulatory approvals for pharmaceutical products can be
substantial. Our ability to commercialize any of our products in
development is dependent upon the success of development efforts in clinical
studies. If these clinical trials fail to produce satisfactory results, or if we
are unable to maintain the financial and operational capability to complete
these development efforts, we may be unable to generate
revenues. Even if we obtain regulatory approvals, the timing or scope
of any approvals may prohibit or reduce our ability to commercialize products
successfully. For example, if the approval process takes too long, we
may miss market opportunities and give other companies the ability to develop
competing products or establish market dominance. Additionally, the
terms of any approvals may not have the scope or breadth needed for us to
commercialize products successfully.
We
may not be successful in developing or marketing future products if we cannot
meet extensive regulatory requirements of the FDA and other regulatory agencies
for quality, safety and efficacy.
The
success of our research and development efforts is dependent in part upon the
ability of the Group, its contractors or potential partners, and its products to
meet and to continue to meet regulatory requirements in the jurisdictions where
we or potential partners ultimately intend to sell such products. The
development, manufacture and marketing of pharmaceutical products are subject to
extensive regulation by governmental authorities in the United States, the
European Union, Japan and elsewhere. In the United States, the FDA
generally requires pre-clinical testing and clinical trials of each drug to
establish its safety and efficacy and extensive pharmaceutical
development to
ensure its quality before its introduction into the
market. Regulatory authorities in other jurisdictions impose similar
requirements. Amarin will be commencing two phase III clinical trials
with AMR101 in lowering triglycerides and continues its ongoing studies and
plans for future toxicology, pharmacology and metabolism studies of AMR101. The
process of obtaining regulatory approvals is lengthy and expensive and the
issuance of such approvals is uncertain. The commencement and rate of
completion of clinical trials and the timing of obtaining marketing approval
from regulatory authorities may be delayed by many factors, including:
·
|
the
inability to manufacture sufficient quantities of qualified materials
under current good manufacturing practices for use in clinical
trials;
|
·
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slower
than expected rates of patient
recruitment;
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·
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the
inability to observe patients adequately after
treatment;
|
·
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changes
in regulatory requirements for clinical or preclinical
studies;
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·
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the
lack of effectiveness during clinical
trials;
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·
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unforeseen
safety issues emerge in clinical or preclinical
studies;
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·
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delay,
suspension, or termination of a trial by the institutional review board
responsible for overseeing the study at a particular study
site;
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·
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unanticipated
changes to the requirements imposed by regulatory authorities
on the extent, nature or timing of studies to be conducted on quality,
safety and efficacy; and
|
·
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government
or regulatory delays or “clinical holds” requiring suspension or
termination of a trial.
|
Even if
we obtain positive results from early stage pre-clinical or clinical trials, we
may not achieve the same success in future trials. Clinical trials
that we or potential partners conduct may not provide sufficient safety and
effectiveness data to obtain the requisite regulatory approvals for product
candidates. The failure of clinical trials to demonstrate safety and
effectiveness for our desired indications could harm the development of that
product candidate as well as other product candidates, and our business and
results of operations would suffer.
Any
approvals that are obtained may be limited in scope, or may be accompanied by
burdensome post-approval study or other requirements. This could
adversely affect our ability to earn revenues from the sale of such
products. Even in circumstances where products are approved by a
regulatory body for sale, the regulatory or legal requirements may change over
time, or new safety or efficacy information may be identified concerning a
product, which may lead to the withdrawal of a product from the market.
Additionally, even after approval, a marketed drug and its manufacturer are
subject to continual review. The discovery of previously unknown
problems with a product or manufacturer may result in restrictions on that
product or manufacturer, including withdrawal of the product from the market,
which would have a negative impact on our potential revenue
stream.
After
approval, our products will be subject to extensive government
regulation.
Once a
product is approved, numerous post-approval requirements apply. Among
other things, the holder of an approved New Drug Application (“NDA”) or other
license is subject to periodic and other monitoring and reporting obligations
enforced by the FDA and other regulatory bodies, including obligations to
monitor and report adverse events and instances of the failure of a product to
meet the specifications in the approved application. Application
holders must also submit advertising and other promotional material to
regulatory authorities and report on ongoing clinical trials.
With
respect to sales and marketing activities by our partners, advertising and
promotional materials must comply with FDA rules in addition to other
potentially applicable federal and local laws in the United States and in other
countries. In the United States, the distribution of product samples
to physicians must comply with the requirements of the U.S. Prescription Drug
Marketing Act. Manufacturing facilities remain subject to FDA
inspection and must continue to adhere to the FDA’s current good manufacturing
practice requirements. Application holders must obtain FDA approval
for product and manufactu-
ing
changes, depending on the nature of the change. Sales, marketing, and
scientific/educational grant programs must also comply with the U.S.
Medicare-Medicaid Anti-Fraud and Abuse Act, as amended, the U.S. False Claims
Act, as amended and similar state laws. Pricing and rebate programs
must comply with the U.S. Medicaid rebate requirements of the Omnibus Budget
Reconciliation Act of 1990, as amended. If products are made
available to authorized users of the U.S. Federal Supply Schedule of the General
Services Administration, additional laws and requirements apply. All
of these activities are also potentially subject to U.S. federal and state
consumer protection and unfair competition laws. Similar requirements
exist in all of these areas in other countries.
Depending
on the circumstances, failure to meet these post-approval requirements can
result in criminal prosecution, fines or other penalties, injunctions, recall or
seizure of products, total or partial suspension of production, denial or
withdrawal of pre-marketing product approvals, or refusal to allow us to enter
into supply contracts, including government contracts. In addition,
even if we or our potential partners comply with FDA and other requirements, new
information regarding the safety or effectiveness of a product could lead the
FDA to modify or withdraw a product approval. Adverse regulatory
action, whether pre- or post-approval, can potentially lead to product liability
claims and increase our product liability exposure. We or our
potential partners must also compete against other products in qualifying for
reimbursement under applicable third party payment and insurance
programs.
Our
future products may not be able to compete effectively against those of our
competitors.
The
pharmaceutical industry is highly competitive. If we are successful in
completing the development of any of our products, we may face competition to
the extent other pharmaceutical companies have on the market or are able to
develop products for the treatment of similar indications. Potential competitors
in this market include companies with greater resources and name recognition
than us. Furthermore, to the extent we are able to acquire or develop
additional marketable products in the future such products will compete with a
variety of other products within the United States or elsewhere, possibly
including established drugs and major brand names. Competitive
factors, including generic competition, could force us to lower prices or could
result in reduced sales. In addition, new products developed by
others could emerge as competitors to our future products. Products
based on new technologies or new drugs could render our products obsolete or
uneconomical.
Our
potential competitors both in the United States and Europe include large,
well-established pharmaceutical companies, specialty pharmaceutical sales and
marketing companies, and specialized cardiovascular and neurology
companies. In addition, we may compete with universities and other
institutions involved in the development of technologies and products that may
compete with ours. Many of our competitors will likely have greater
resources than us, including financial, product development, marketing,
personnel and other resources. Should a competing product obtain
marketing approval prior to any of our products, this would significantly erode
the projected revenue streams for our product.
The
success of our future products will also depend in large part on the willingness
of physicians to prescribe these products to their patients. Our
future products may compete against products that have achieved broad
recognition and acceptance among medical professionals. In order to
achieve an acceptable level of subscriptions for our future products, we must be
able to meet the needs of both the medical community and end users with respect
to cost, efficacy and other factors.
Our
supply of products for clinical trials and ultimately for commercial supply is
dependent upon relationships with manufacturers and key suppliers.
We have
no in-house manufacturing capacity and, to the extent we are successful in
completing the development of our products and/or acquiring or developing other
marketable products in the future, we will be obliged to rely on contract
manufacturers to produce our products. We cannot assure you that we
will successfully manufacture any product we may develop, either independently
or under manufacturing arrangements, if any, with third party manufacturers.
Moreover, if any manufacturer should cease doing business with us or experience
delays, shortages of supply or excessive demands on their capacity, we may not
be able to obtain adequate quantities of product in a timely manner, or at
all. Manufacturers are required to comply with current NDA
commitments and good manufacturing practices requirements enforced by the FDA,
and similar requirements of other countries. The failure by a
manufacturer to comply with these requirements could affect its ability to
provide us with product.
Any
manufacturing problem or the loss of a contract manufacturer could be disruptive
to our operations and result in lost sales. Additionally, we will be reliant on
third parties to supply the raw materials needed to manufacture our potential
products. Any reliance on suppliers may involve several risks,
including a potential inability to obtain critical materials and reduced control
over production costs, delivery schedules, reliability and
quality. Any unanticipated disruption to future contract manufacture
caused by problems at suppliers could delay shipment of products, increase our
cost of goods sold and result in lost sales.
In the
past and currently, we purchase all API for AMR101from a single supplier with a
single manufacturing facility. While we have contractual freedom to source API
elsewhere, there is no guarantee we will either be successful in identifying
alternative supplier(s) or that such future supplier(s) will have the
manufacturing capacity to meet future requirements. Our current supplier
currently does not have sufficient manufacturing capacity to meet expected
future commercial supply requirements and we cannot assure you that it or an
alternative supplier will have the necessary capacity to meet our
requirements.
We
may not be able to grow our business unless we can acquire or in-license new
products.
During
recent years, we pursued a strategy of product acquisitions and in-licensing in
order to supplement our own research and development activity. Our
success in this regard will be dependent on our ability to identify other
companies that are willing to sell or license product lines to us. We
will be competing for these products with other parties, many of whom have
substantially greater financial, marketing and sales resources than we
do. Even if suitable products are available, depending on competitive
conditions we may not be able to acquire rights to additional products on
acceptable terms, or at all. Our potential inability to acquire
additional products or successfully introduce new products could have a material
adverse effect on our business.
In
order to commercialize our future products, we may need to find a collaborative
partner to help market and sell our products.
Our
strategy for commercializing currently anticipates that we will enter into
collaborative arrangements with one or more pharmaceutical companies that have
product development resources and expertise, established distribution systems
and direct sales forces to successfully market our products. If so, we will be
reliant on one or more of these strategic partners to generate revenue on our
behalf.
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.
The
carrying value of our EN101 intangible asset is dependent on the success or
failure of partnering activities and future development work.
At
December 31, 2008, our EN101 intangible asset had a carrying value of $19.9
million. If our efforts to find a development partner or licensee for
EN101 are unsuccessful or if future development work is unsuccessful, the
valuation of our EN101 intangible asset would likely be impaired. We
are in discussions with the licensor of EN101 to amend certain aspects of our
license. If these discussions are unsuccessful our partnering efforts
could be adversely impacted.
The
planned expansion of our business may strain our resources.
We
currently operate with limited resources, the addition of any new products could
require a significant expansion of our operations, including the recruitment,
hiring and training of additional personnel, particularly those with a clinical
or regulatory background. Any failure to recruit necessary personnel
could have a material adverse effect on our business. Additionally,
the expansion of our operations and work force could create a strain on our
financial and management resources and it may require us to add management
personnel.
We
may incur potential liabilities relating to discontinued operations or
products.
In
October 2003, we sold Gacell Holdings AB, the Swedish holding company of Amarin
Development AB, which we refer to as ADAB, our Swedish drug development
subsidiary, to Watson Pharmaceuticals, Inc. In February 2004, we sold
our U.S. subsidiary, Amarin Pharmaceuticals Inc., and certain assets, to
Valeant. In connection with these transactions, we provided a number
of representations and warranties to Watson and Valeant regarding the respective
businesses sold to them, and other matters, and we undertook to indemnify Watson
and Valeant under certain circumstances for breaches of such representations and
warranties. We are not aware of any circumstances which could
reasonably be expected to give rise to an indemnification obligation under our
agreements with either Watson or Valeant. However, we cannot predict
whether matters may arise in the future which were not known to us and which,
under the terms of the relevant agreements, could give rise to a claim against
us.
We
will be dependent on patents, proprietary rights and
confidentiality.
Because
of the significant time and expense involved in developing new products and
obtaining regulatory approvals, it is very important to obtain patent and trade
secret protection for new technologies, products and processes. Our
ability to successfully implement our business plan will depend in large part on
our ability to:
|
·
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acquire
patented or patentable products and
technologies;
|
|
·
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obtain
and maintain patent protection or market exclusivity for our current and
acquired products;
|
|
·
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preserve
any trade secrets relating to our current and future products;
and
|
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·
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operate
without infringing the proprietary rights of third
parties.
|
Although
we intend to make reasonable efforts to protect our current and future
intellectual property rights and to ensure that any proprietary technology we
acquire does not infringe the rights of other parties, we may not be able to
ascertain the existence of all potentially conflicting claims. Therefore, there
is a risk that third parties may make claims of infringement against our current
or future products or technologies. In addition, third parties may be
able to obtain patents that prevent the sale of our current or future products
or require us to obtain a license and pay significant fees or royalties in order
to continue selling such products.
We may in
the future discover the existence of products that infringe upon patents that we
own or that have been licensed to us. Although we intend to protect
our trade secrets and proprietary know-how through confidentiality agreements
with our manufacturers, employees and consultants, we may not be able to prevent
our competitors from breaching these agreements or third parties from
independently developing or learning of our trade secrets.
We
anticipate that competitors may from time to time oppose our efforts to obtain
patent protection for new technologies or to submit patented technologies for
regulatory approvals. Competitors may seek to challenge patent
applications or existing patents to delay the approval process, even if the
challenge has little or no merit. Patent challenges are generally
highly technical, time consuming and expensive to pursue. Were we to
be subject to one or more patent challenges, that effort could consume
substantial time and resources, with no assurances of success, even when holding
an issued patent.
The
loss of any key management or qualified personnel could disrupt our
business.
We are
highly dependent upon the efforts of our senior management. The loss
of the services of one or more members of senior management could have a
material adverse effect on us. As a small company with a streamlined
management structure, the departure of any key person could have a significant
impact and would be potentially disruptive to our business until such time as a
suitable replacement is hired. Furthermore, because of the
specialized nature of our business, as our business plan progresses we will be
highly dependent upon our ability to attract and retain qualified scientific,
technical and key management personnel. There is intense competition
for qualified personnel in the areas of our activities. In this
environment, we may not be able to attract and retain the personnel necessary
for the development of our business, particularly if we do not achieve
profitability. The failure to recruit key scientific, technical and
management personnel would be detrimental to our ability to implement our
business plan.
We
are subject to continuing potential product liability.
Although
we disposed of the majority of our former products during 2003 and 2004, we
remain subject to the potential risk of product liability claims relating to the
manufacturing and marketing of our former products during the period prior to
their divestiture. Any person who is injured as a result of using one
of our former products during our period of ownership may have a product
liability claim against us without having to prove that we were at
fault. The potential for liability exists despite the fact that our
former subsidiary, Amarin Pharmaceuticals Inc. conducted all sales and marketing
activities with respect to such products. Although we have not
retained any liabilities of Amarin Pharmaceuticals Inc. in this regard, as the
prior holder of ownership rights to such former products,
third parties could seek to assert potential claims against us. Since
we distributed and sold our products to a wide number of end users, the risk of
such claims could be material.
We do not
at present carry product liability insurance to cover any such
risks. If we were to seek insurance coverage, we may not be able to
maintain product liability coverage on acceptable terms if our claims experience
results in high rates, or if product liability insurance otherwise becomes
costlier or unavailable because of general economic, market or industry
conditions. If we add significant products to our portfolio, we will
require product liability coverage and may not be able to secure such coverage
at reasonable rates or at all.
Product
liability claims could also be brought by persons who took part in clinical
trials involving our current or former development stage products. A
successful claim brought against us could have a material adverse effect on our
business.
Amarin
was responsible for the sales and marketing of Permax from May 2001 until
February 2004. On May 17, 2001, Amarin acquired the U.S. sales and marketing
rights to Permax from 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
International.
In late
2002, Eli Lilly, as the holder of the NDA for Permax, received a recommendation
from the FDA to consider making a change to the package insert for Permax based
upon the very rare observation of cardiac valvulopathy in patients taking
Permax. While Permax has not been definitely proven as the cause of this
condition, similar reports have been notified in patients taking other ergot-
derived pharmaceutical products, of which Permax is an example. In early 2003,
Eli Lilly amended the package insert for Permax to reflect the risk of cardiac
valvulopathy in patients taking Permax and also sent a letter to a number of
doctors in the United States describing this potential risk. Causation has not
been established, but is thought to be consistent with other fibrotic side
effects observed in Permax.
On March
29, 2007, the FDA announced that the manufacturers of pergolide drug products
will voluntarily remove these drug products, including Permax, from the market.
Further information about the removal of Permax and other pergolide drug
products is available on the FDA’s website.
During
2008, two lawsuits alleging claims related to cardiac valvulopathy and Permax
were filed in March and August respectively. One of the lawsuits was
dismissed in February 2009 and the remaining case is currently pending in the
United States. Among others, Eli Lilly, Elan, Valeant, Amarin Pharmaceuticals,
and Amarin are named as defendants in this lawsuit, however Amarin has not been
formally served with the complaint from the lawsuit. In addition, six cases
alleging claims related to cardiac valvulopathy and Permax were filed in April
2008 in the United States and currently remain pending. Eli Lily, Valeant,
Amarin Pharmaceuticals and unidentified parties are named as defendants in these
cases, and are defending against the claims and allegations. Amarin has not been
named as defendant or served with the complaints from these cases.
During
2009, two lawsuits alleging claims related to cardiac valvulopathy and Permax
were filed in March and are currently pending in the United States. Eli Lilly,
Elan, Valeant, Amarin Pharmaceuticals, Amarin and other parties are named as
defendants in these lawsuits. Amarin has not been formally served with the
complaint from these lawsuits. A third lawsuit, also filed in March, was
dismissed in September only as to Amarin for the plaintiff’s failure to
prosecute the case against Amarin.
Ten other
claims related to cardiac valvulopathy and Permax and one claim related to
compulsive gambling and Permax are or were being threatened against Eli Lilly,
Elan, and/or Valeant, and could possibly implicate Amarin.
We have
reviewed the position and having taken external legal advice and consider the
potential risk of significant liability arising for Amarin from these legal
actions to be remote. No provision is booked in the accounts at December 31,
2008.
The
price of our ADSs and Ordinary Shares may be volatile.
The stock
market has from time to time experienced significant price and volume
fluctuations that may be unrelated to the operating performance of particular
companies. In addition, the market prices of the securities of many
pharmaceutical and medical technology companies have been especially volatile in
the past, and this trend is expected to continue in the future. Our
ADSs may also be subject to volatility as a result of their limited trading
market. At December 31, 2008 we had 26,551,388 ADSs representing
Ordinary Shares outstanding and 495,328 Ordinary Shares outstanding (which are
not held in the form of ADSs). There is a risk that there may not be
sufficient liquidity in the market to accommodate significant increases in
selling activity or the sale of a large block of our securities. Our
ADSs have historically had limited trading volume, which may also result in
volatility. During the twelve-month period ending December 31, 2008,
the average daily trading volume for our ADSs was 17,772.
If our
public float and the level of trading remain at limited levels over the long
term, this could result in volatility and increase the risk that the market
price of our ADSs and Ordinary Shares may be affected by factors such
as:
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the
announcement of new products or
technologies;
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innovation
by us or our competitors;
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developments
or disputes concerning any future patent or proprietary
rights;
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actual
or potential medical results relating to our products or our competitors’
products;
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interim
failures or setbacks in product
development;
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regulatory
developments in the United States, the European Union or other
countries;
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currency
exchange rate fluctuations; and
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period-to-period
variations in our results of
operations.
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A
Share price of less than $1.00 may impact the company’s NASDAQ
listing.
Amarin is
currently trading above $1.00; however, in the period October 6, 2008 to April
7, 2009 Amarin was trading beneath $1.00. Due to the current state of
capital markets, on October 16 2008, NASDAQ and the SEC suspended the
application of the $1.00 minimum bid price rule until April 20, 2009. This
suspension was further extended to July 19, 2009. NASDAQ noted that on
September 30, 2008, 64 securities were trading at less than $1 while in mid
November, 2008 that number had jumped to 344. The suspension was removed
on July 20, 2009. If Amarin’s closing bid price is less than $1.00 for 30
consecutive trading days, Amarin will receive a NASDAQ staff deficiency letter
indicating that the Company is not in compliance with the minimum bid price
requirement for continued listing. Such a letter would trigger an
automatic 180 calendar day period within which the company could regain
compliance. Compliance is regained at any time during this period, if the
Amarin closing bid price is $1.00 per share or more for a minimum of 10
consecutive trading days. If compliance cannot be demonstrated by the end
of the 180 days, Amarin will be afforded an additional 180 calendar day
compliance period if Nasdaq determines at that time that the Company meets the
remaining Nasdaq Capital Market initial listing criteria in Rule 5215(b), except
for the bid price requirement. If Amarin was not eligible for an additional
compliance period, NASDAQ would provide written notification that the Company’s
securities will be delisted. At that time, Amarin could appeal NASDAQ’s
determination to delist its securities to a Listing Qualifications
Panel.
The
issuances of ADSs and Ordinary Shares upon the conversion or exercise of our
securities will dilute the ownership interest of existing stockholders,
including stockholders who had previously exercised their warrants.
The
issuances of ADSs and Ordinary Shares in connection with the exercise of our
warrants will dilute the ownership interest of existing
stockholders. Any sales in the public market of the ADSs and Ordinary
Shares issuable upon such exercise could adversely affect prevailing market
prices of our ADSs and Ordinary Shares.
Future
sales of our ADSs and/or Ordinary Shares in the public market could lower the
market price for our ADSs and/or Ordinary Shares.
In the
future, we may sell additional ADSs and/or Ordinary Shares to raise capital or
pursuant to contractual obligations. See “We may have to issue
additional equity, leading to shareholder dilution.” We cannot
predict the size of future issuances or sales of our ADSs and/or Ordinary Shares
to raise capital or the effect, if any, that they may have on the market price
for our ADSs and/or Ordinary Shares. The issuances and sales of
substantial amounts of ADSs and/or Ordinary Shares, or the perception that such
issuances and sales may occur, could adversely affect the market price of our
ADSs and/or Ordinary Shares.
We
may lose our foreign private issuer status in the future, which could result in
significant additional costs and expenses.
We are a “foreign private issuer,” as
such term is defined in Rule 405 under the U.S. Securities Act of 1933, as
amended, and, therefore, we are not required to comply with all the periodic
disclosure and current reporting requirements of the U.S. Securities Exchange
Act of 1934, as amended, and related rules and regulations.
In the future, we would lose our
foreign private issuer status if a majority of our directors are U.S citizens or
residents and we continue to fail to meet additional requirements necessary to
avoid loss of foreign private issuer status. The regulatory and compliance costs
to us under U.S. securities laws as a U.S. domestic issuer may be significantly
more than costs we incur as a foreign private issuer. If we are not a foreign
private issuer, we will be required to file periodic reports and registration
statements on U.S. domestic issuer forms with the U.S. Securities and Exchange
Commission, which are more detailed and extensive than the forms available to
foreign private issuer. We may also be required to prepare our financial
statements in accordance with U.S. generally accepted accounting principles. In
addition we may lose our ability to rely upon exemptions from certain corporate
governance requirements on U.S. stock exchanges that are available to foreign
private issuers.
U.S.
Holders of our Ordinary Shares or ADSs could be subject to material adverse tax
consequences if we are considered a PFIC for U.S. federal income tax
purposes.
There is
a risk that we will be classified as a passive foreign investment company, or
“PFIC”, for U.S. federal income tax purposes. Our status as a PFIC
could result in a reduction in the after-tax return to U.S. Holders of our
Ordinary Shares or ADSs and may cause a reduction in the value of such
shares. We will be classified as a PFIC for any taxable year in which
(i) 75% or more of our gross income is passive income or (ii) at least 50% of
the average value of all our assets produces or are held for the production of
passive income. For this purpose, passive income includes interest,
gains from the sale of stock, and royalties that are not derived in the active
conduct of a trade or business. Because we receive interest and may
receive royalties, there is a risk that we will be considered a PFIC under the
income test described above. In addition, because of our cash
position and our ownership of patents, there is a risk that we will be
considered a PFIC under the asset test described above. While we
believe that the PFIC rules were not intended to apply to companies such as us
that focus on research, development and commercialization of drugs, no assurance
can be given that the U.S. Internal Revenue Service or a U.S. court would
determine that, based on the composition of our income and assets, we are not a
PFIC currently or in the future. If we were classified as a PFIC,
U.S. holders of our Ordinary Shares or ADSs could be subject to greater U.S.
income tax liability than might otherwise apply, imposition of U.S. income tax
in advance of when tax would otherwise apply, and detailed tax filing
requirements that would not otherwise apply. The PFIC rules are
complex and a U.S. Holder of our Ordinary Shares or ADSs is urged to consult its
own tax advisors regarding the possible application of the PFIC rules to it in
its particular circumstances.
A
change in our tax residence could have a negative effect on our future
profitability
Although
we are incorporated in England and Wales, our directors seek to ensure that our
affairs are conducted in such a manner that we are resident in Ireland for
Irish, UK and U.S. tax purposes. It is possible that in the future,
whether as a result of a change in law or the practice of any relevant tax
authority or as a result of any change in the conduct of our affairs following a
review by our directors, we could become, or be regarded as having become
resident in a jurisdiction other than Ireland. Should we cease to be
an Irish tax resident, we may be subject to a charge to Irish capital gains tax
on our assets. Similarly, if the tax residency of any of our
subsidiaries were to change from their current jurisdiction for any of the
reasons listed above, we may be subject to a charge to local capital gains tax
charge on the assets.
U.S.
Holders of our Ordinary Shares or ADSs may be subject to U.S. income taxation at
ordinary income tax rates on undistributed earnings and profits.
Given our
current ownership, we expect that we are a controlled foreign corporation,
(“CFC”) for the taxable year 2008 and we may be classified as a CFC in future
taxable years. If we are classified as a CFC for U.S. federal income
tax purposes, any shareholder that is a U.S. person that owns directly,
indirectly or by attribution, 10% or more of the voting power of our outstanding
shares may be subject to current U.S. income taxation at ordinary income tax
rates on all or a portion of the Company’s undistributed earnings and profits
attributable to “subpart F income.” Such 10% shareholder may also be
taxable at ordinary income tax rates on any gain realized on a sale of Ordinary
Shares or ADS, to the extent of the Company’s current and accumulated earnings
and profits attributable to such shares. The CFC rules are complex
and U.S. Holders of our Ordinary shares or ADSs are urged to consult their own
tax advisors regarding the possible application of the CFC rules to them in
their particular circumstances.
The
rights of our shareholders may differ from the rights typically offered to
shareholders of a U.S. corporation.
We are
incorporated under English law. The rights of holders of Ordinary Shares and,
therefore, certain of the rights of holders of ADSs, are governed by English
law, including the provisions of the Companies Act 2006, and by our memorandum
and articles of association. These rights differ in certain respects from the
rights of shareholders in typical U.S. corporations. The principal differences
include the following:
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Under
English law, each shareholder present at a meeting has only one vote
unless demand is made for a vote on a poll, in which each holder gets one
vote per share owned. Under U.S. law, each shareholder
typically is entitled to one vote per share at all
meetings. Under English law, it is only on a poll that the
number of shares determines the number of votes a holder may
cast. You should be aware, however, that the voting rights of
ADSs are also governed by the provisions of a deposit agreement with our
depositary bank.
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Under
English law, each shareholder generally has preemptive rights to subscribe
on a proportionate basis to any issuance of shares. Under U.S.
law, shareholders generally do not have preemptive rights unless
specifically granted in the certificate of incorporation or
otherwise.
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Under
English law, certain matters require the approval of 75% of the
shareholders, including amendments to the memorandum and articles of
association. This may make it more difficult for us to complete
corporate transactions deemed advisable by our board of
directors. Under U.S. law, generally only majority shareholder
approval is required to amend the certificate of incorporation or to
approve other significant
transactions.
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Under
English law, shareholders may be required to disclose information
regarding their equity interests upon our request, and the failure to
provide the required information could result in the loss or restriction
of rights attaching to the shares, including prohibitions on the transfer
of the shares, as well as restrictions on dividends and other
payments. Comparable provisions generally do not exist under
U.S. law.
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The
quorum requirement for a shareholders’ meeting is a minimum of two persons
present in person or by proxy. Under U.S. law, a majority of the shares
eligible to vote must generally be present (in person or by proxy) at a
shareholders’ meeting in order to constitute a quorum. The
minimum number of shares required for a quorum can be reduced pursuant to
a provision in a company’s certificate of incorporation or bylaws, but
typically not below one-third of the shares entitled to vote at the
meeting.
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U.S.
shareholders may not be able to enforce civil liabilities against
us.
A number
of our directors and executive officers and those of each of our subsidiaries,
including Amarin Finance Limited, are non-residents of the United States, and
all or a substantial portion of the assets of such persons are located outside
the United States. As a result, it may not be possible for investors to effect
service of process within the United States upon such persons or to enforce
against them judgments obtained in U.S. courts predicated upon the civil
liability provisions of the federal securities laws of the United
States. We have been advised by our English solicitors
that there is doubt as to the enforceability in England in original actions, or
in actions for enforcement of judgments of U.S. courts, of civil liabilities to
the extent predicated upon the federal securities laws of the United
States. Amarin Finance Limited is an exempted company limited by
shares organized under the laws of Bermuda. We have been advised by
our Bermuda attorneys that uncertainty exists as to whether courts in Bermuda
will enforce judgments obtained in other jurisdictions (including the United
States) against us or our directors or officers under the securities laws of
those jurisdictions or entertain actions in Bermuda against us or our directors
or officers under the securities laws of other jurisdictions.
Foreign
currency fluctuations may affect our future financial results or cause us to
incur losses.
We
prepare our financial statements in U.S. Dollars. Since our strategy involves
the development of products for the U.S. market, a significant part of our
clinical trial expenditures are denominated in U.S. Dollars and we anticipate
that the majority of our future revenues will be denominated in U.S. Dollars.
However, a significant portion of our costs are denominated in pounds sterling
and euro as a result of our being engaged in activities in the United Kingdom
and the European Union. As a consequence, the results reported in our financial
statements are potentially subject to the impact of currency fluctuations
between the U.S. Dollar on the one hand, and pounds sterling and euro on the
other hand. We are focused on development activities and do not anticipate
generating on-going revenues in the short-term. Accordingly, we do
not engage in significant currency hedging activities in order to limit the risk
of exchange rate fluctuations. However, if we should commence
commercializing any products in the United States, changes in the relation of
the U.S. Dollar to the pound sterling and/or the euro may affect our revenues
and operating margins. In general, we could incur losses if the U.S.
Dollar should become devalued relative to pounds sterling and/or the
euro.
We
do not currently have the capability to undertake marketing, or sales of any
potential products.
We have
not invested in marketing or product sales resources. We cannot
assure you that we will be able to acquire such resources. We cannot
assure you that we will successfully market any product we may develop, either
independently or under marketing arrangements, if any, with other
companies. To the extent that we enter into contractual relationships
with other companies to market our products, if any, the success of such
products may depend on the success of securing and maintaining such contractual
relationships the efforts of those other companies (and any subcontractors they
engage).
We
have limited personnel to oversee out-sourced contract manufacturing, clinical
testing and the regulatory approval process.
It is
likely that we will also need to hire additional personnel skilled in the
manufacturing, clinical testing and regulatory compliance process if we develop
additional product candidates with commercial potential. We do not
currently have the capability to conduct clinical testing in-house and do not
currently have plans to develop such a capability. We out-source our
clinical testing to contract research organizations. We currently
have a limited number of employees and certain other outside consultants who
oversee the contract research organizations involved in clinical testing of our
compounds.
We
cannot assure you that our limited oversight of the contract research
organizations will suffice to avoid significant problems with the protocols and
conduct of the clinical trials.
We depend
on contract research organizations to conduct our pre-clinical and our clinical
testing. We have engaged and intend to continue to engage third party
contract research organizations and other third parties to help us develop our
drug candidates. Although we have designed the clinical trials for
drug candidates, the contract re-
search
organizations will be conducting all of our clinical trials. As a
result, many important aspects of our drug development programs have been and
will continue to be outside of our direct control. In addition, the
contract research organizations may not perform all of their obligations under
arrangements with us. If the contract research organizations do not
perform clinical trials in a satisfactory manner or breach their obligations to
us, the development and commercialization of any drug candidate may be delayed
or precluded. We cannot control the amount and timing of resources
these contract research organizations devote to our programs or product
candidates. The failure of any of these contract research
organizations to comply with any governmental regulations would substantially
harm our development and marketing efforts and delay or prevent regulatory
approval of our drug candidates. If we are unable to rely on clinical
data collected by others, we could be required to repeat, extend the duration
of, or increase the size of our clinical trials and this could significantly
delay commercialization and require significantly greater
expenditures.
Despite
the use of confidentiality agreements and/or proprietary rights agreements,
which themselves may be of limited effectiveness, it may be difficult for us to
protect our trade secrets.
We rely
on trade secrets to protect technology in cases when we believe patent
protection is not appropriate or obtainable. However, trade secrets
are difficult to protect. While we require certain of our academic
collaborators, contractors and consultants to enter into confidentiality
agreements, we may not be able to adequately protect our trade secrets or other
proprietary information.
Potential
technological changes in our field of business create considerable
uncertainty.
We are
engaged in the biopharmaceutical field, which is characterized by extensive
research efforts and rapid technological progress. New developments
in research are expected to continue at a rapid pace in both industry and
academia. We cannot assure you that research and discoveries by
others will not render some or all of our programs or product candidates
uncompetitive or obsolete. Our business strategy is based in part
upon new and unproven technologies to the development of biopharmaceutical
products for the treatment of cardiovascular diseases. We cannot
assure you that unforeseen problems will not develop with these technologies or
applications or that commercially feasible products will ultimately be developed
by us.
Third-party
reimbursement and health care cost containment initiatives and treatment
guidelines may constrain our future revenues.
Our
ability to market successfully our existing and future new products will depend
in part on the level of reimbursement that government health administration
authorities, private health coverage insurers and other organizations provide
for the cost of our products and related treatments. Countries in
which our products are sold through reimbursement schemes under national health
insurance programs frequently require that manufacturers and sellers of
pharmaceutical products obtain governmental approval of initial prices and any
subsequent price increases. In certain countries, including the
United States, government-funded and private medical care plans can exert
significant indirect pressure on prices. We may not be able to sell
our products profitably if adequate prices are not approved or reimbursement is
unavailable or limited in scope. Increasingly, third-party payers
attempt to contain health care costs in ways that are likely to impact our
development of products including:
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failing
to approve or challenging the prices charged for health care
products;
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introducing
reimportation schemes from lower priced
jurisdictions;
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limiting
both coverage and the amount of reimbursement for new therapeutic
products;
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denying
or limiting coverage for products that are approved by the regulatory
agencies but are considered to be experimental or investigational by
third-party payers;
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refusing
to provide coverage when an approved product is used in a way that has not
received regulatory marketing approval;
and
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refusing
to provide coverage when an approved product is not appraised favorably by
the National Institute for Clinical Excellence in the U.K., or similar
agencies in other countries.
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We
are undergoing significant organizational change. Failure to manage
disruption to the business or the loss of key personnel could have an adverse
effect on our business.
We are
making significant changes to both our management structure and the
locations from which we operate. We opened a new office in Mystic,
CT, in September 2008 and we plan to transition certain corporate activities in
early 2010. As a result of this, in the short term, morale may be lowered and
key employees may be distracted from their usual role. This could
result in delays in development projects, failure to achieve managerial targets
or other disruption to the business which could have material adverse affects on
our business and results of operations.
Item
4 Information
on the Company
A. History
and Development of the Company
Amarin
Corporation plc (formerly Ethical Holdings plc) is a public limited company
listed in the U.S. on the NASDAQ Capital Market. 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.
Our
registered office is located at 110 Cannon Street, London, EC4N 6AR, England.
Our principal executive offices are located at First Floor, Block 3, The Oval,
Shelbourne Road, Ballsbridge, Dublin 4, Ireland and our telephone number is
+353−1−6699010. The directors are responsible for the maintenance and integrity
of our website, www.amarincorp.com. Our principal research and development
facilities are located at 12 Roosevelt Avenue, Mystic, Connecticut, 06355,
USA.
During
2007, we announced a cardiovascular development strategy leveraging our
proprietary expertise and intellectual property in lipid science to target
billion dollar market opportunities such as dyslipidemia. We also focused on
expanding and strengthening our research and development management team. In
September 2008, we opened our research and development headquarters in Mystic,
Connecticut, USA. This office is headed by Dr. Declan Doogan, Head of Research
and Development. Dr. Doogan was previously Senior Vice President and Head of
Worldwide Development at Pfizer Global Research and Development.
We are
now focused on developing our lead candidate AMR101 – a prescription grade
Omega-3 fatty acid – which is expected to enter Phase 3 clinical trials for
hypertriglyceridemia and mixed dyslipidemia in Q4 2009. This program leverages
our lipid science expertise, the established safety and tolerability profile of
AMR101 from our previous clinical trials and the known therapeutic benefits of
essential fatty acids, particularly Omega-3s, in treating cardiovascular
disease.
We also
intend to partner our CNS pipeline, which includes candidates for Huntington’s
disease, myasthenia gravis and Parkinson’s disease.
In the
period from late 2004 to late 2009, we completed a series of financings raising
aggregate gross proceeds of approximately $198.7 million, including $24.5
million from our current and former directors and officers.
Business
Overview
Our
Business
Amarin is
a late-stage biopharmaceutical company with a focus on cardiovascular disease.
Amarin’s cardiovascular disease programs capitalize on our expertise in the
field of lipid science and the known therapeutic benefits of essential fatty
acids in cardiovascular disease. Amarin has a range of clinical and preclinical
stage compounds
to treat
central nervous system (CNS) disorders, including Huntington’s disease,
myasthenia gravis and Parkinson’s disease, all of which are available for
partnering. The following chart summarises Amarin’s pipeline, comprising core
cardiovascular programs and non-core CNS programs:
Cardiovascular
Disease Programs
AMR101
AMR101, a
prescription grade Omega-3 fatty acid, comprising not less than 96% ultra pure
ethyl ester of eicosapentaenoic acid. It is a long chain of highly unsaturated
fatty acid. AMR101 is believed to impact on a number of biological factors in
the body such as anti-inflammatory mechanisms, cell membrane composition and
plasticity, triglyceride levels and regulation of glucose
metabolism.
AMR101
for Hypertriglyceridemia and Mixed Dyslipidemia
AMR101 is
being progressed to Phase 3 clinical development for the treatment of
hypertriglyceridemia and mixed dyslipidemia. Hypertriglyceridemia refers to a
condition in which patients have high blood levels of triglycerides and is
recognized as an independent risk factor for cardiac disease. Mixed dyslipidemia
refers to a condition in which patients have a combination of two or more lipid
abnormalities including elevated triglycerides, low high-density lipoprotein
(HDL) cholesterol, and elevated low-density lipoprotein (LDL) cholesterol and is
believed to affect more than 34 million in the U.S. alone. Both
hypertriglyceridemia and mixed dyslipidemia are components of a range of lipid
disorders collectively referred to as dyslipidemia. The overall dyslipidemia
population in the U.S. is believed to be in excess of 100 million, with annual
drug treatments in the U.S. for this population now exceeding $25 billion,
dominated by statin therapies. Growth in the non-statin segment is believed to
be a reflection of the broadening of dyslipidemia treatment beyond reduction in
LDL cholesterol to other lipid parameters such as HDL cholesterol and
triglycerides.
The
current treatments to lower triglycerides include fibrates, and more recently in
the U.S., a prescription grade Omega-3 fatty acid. Currently there is only one
FDA approved prescription grade Omega-3 fatty acid, known as Lovaza (Omacor in
Europe) marketed by GlaxoSmithKline. Lovaza, which consists predominately of the
Omega-3 esters EPA and DHA, was launched in the U.S. in 2005. Reported U.S.
sales in 2008 of $540 million represented an annual growth rate of 70% making it
is one of the fastest growing products in the sector with analysts predicting
that the Lovaza/Omacor brands will become a multi-billion dollar
franchise.
The
growth of prescription grade Omega-3 fatty acids, which are known to be highly
effective in lowering triglycerides, is underpinned by the growing acceptance of
high triglycerides as an independent risk factor in
cardiovascular
disease. In addition to their efficacy, their safety and tolerability profile
also make them very suitable for combination treatments, an important treatment
approach in the effective management of dyslipidemia.
A
distinguishing feature of AMR101 is its high EPA purity content at not less than
96%.
Amarin is
planning to commence two Phase 3 trials with AMR101 in 2009. The first is a
pivotal Phase 3 registration trial for the treatment of hypertriglyceridemia,
the second, a Phase 3 trial in mixed dyslipidemia, is aimed at broadening the
potential label for AMR101. Amarin’s development program is designed to position
AMR101 as “best-in-class” in the prescription grade Omega-3 market.
In May
2009, Amarin announced that it had reached agreement with the U.S. Food and Drug
Administration (FDA) under a Special Protocol Assessment (SPA) for a planned
Phase 3 registration clinical trial of AMR101 in patients with
hypertriglyceridemia, or very high triglyceride levels. Pursuant to the SPA, the
Phase 3 trial will be a multi-center, placebo-controlled, randomized,
double-blind, 12-week study to evaluate the efficacy and safety of 2gram or
4gram dose of AMR101, in patients with fasting triglyceride levels of ≥500 mg/dL
(the AMR101 MARINE Study). The primary endpoint in the trial is the percentage
change in triglyceride level from baseline to week 12. Following completion of
the 12-week double-blind treatment period, patients will be eligible to enter a
40-week, open-label, extension period.
The trial
is expected to enroll approximately 240 patients, with enrollment planned to
commence in Q4 2009. The trial will be conducted in centers throughout North and
Central America, Europe, India and South Africa. The Company plans to use the
results of this Phase 3 registration trial as the basis for the submission of a
New Drug Application (NDA) to the FDA.
An SPA is
a written agreement between the Company, as the trial's sponsor, and the FDA
regarding the design, endpoints, and planned statistical analysis of the Phase 3
trial to be used in support of an NDA.
In July
2009, Amarin announced that it had reached agreement with the FDA under an SPA
for a planned Phase 3 clinical trial of AMR101 in patients with mixed
dyslipidemia. The Phase 3 mixed dyslipidemia trial will be a multi-center,
placebo-controlled, randomized, double-blind, 12-week study to evaluate the
efficacy and safety of 2 grams and 4 grams of AMR101 in patients with high
triglyceride levels of ≥200 mg/dL and <500 mg/dL who are on statin therapy.
The primary endpoint in the trial is the percentage change in triglyceride level
from baseline to week 12. This trial is expected to enroll
approximately 650 patients and will be conducted in centers throughout the
United States. The Company plans to use the results of this Phase 3 trial as the
basis for potentially broadening the label for AMR101 beyond treatment for very
high triglycerides to include treatment for high triglycerides, the two patient
groups that need hypotriglyceridemic therapy the most, as classified by the
National Cholesterol Education Program (NCEP) Expert Panel (Adult Treatment
Panel III, ATP III, 2002).
During
2008 Amarin established its Cardiovascular Advisory Group in designing the above
mentioned trials. The Advisory Group, consisting of leading experts in the field
of cardiovascular disease research and development, comprises: Dr. Harold Bays,
Medical Director and President of Louisville Metabolic and Atherosclerosis
Research Center; Professor Philip Calder, Nutritional Immunology at the
University of Southampton, UK; Dr. Michael Criqui, Professor and Chief, Division
of Preventive Medicine, in the Department of Family and Preventive Medicine at
the University of California, San Diego School of Medicine; Dr. Meredith
Hawkins, Professor of Medicine and Director of the Global Diabetes Initiative at
the Albert Einstein College of Medicine in New York; Dr. Sotirios Tsimikas,
Professor of Medicine and Director of Vascular Medicine at the University of
California, San Diego and Dr. Anthony Wierzbicki, Consultant in Chemical
Pathology/Metabolic Medicine at Guy’s and St Thomas’ Hospitals NHS,
UK.
Amarin
has previously investigated AMR101 in central nervous system disorders in
several double-blind, placebo controlled studies, including Phase 3 trials in
Huntington’s disease. Over 900 patients have received AMR101 in these studies,
with over 100 receiving continuous treatment for a year or more. In all studies
performed to date, AMR101 has shown a very good safety and tolerability
profile.
Numerous
independent studies have demonstrated the safety and efficacy of ethyl-EPA in
lowering plasma triglycerides in patients with high triglyceride levels of
varying degrees of severity. In Japan, an ethyl-EPA prescription product has
been approved for the treatment of hyperlipidemia and has been on the market for
eighteen years.
Preclinical
Program: New Lipid Compounds
Amarin is
also investigating a new generation of lipid compounds for pre-clinical
development based on our internal lipid science expertise which are designed to
be more potent than currently available Omega-3 fatty acid
products.
CNS
Programs for Partnering
AMR101
Clinical Development for HD
HD is
inherited as an autosomal dominant disease that gives rise to progressive,
selective (localized) neural cell death associated with choreic movements and
dementia. On April 24, 2007, we announced top line results from two Phase 3
studies with AMR101 in HD. Study data showed no statistically significant
difference in either study between AMR101 and placebo with regard to the primary
and secondary endpoints at 6 months of treatment. These top-line findings were
inconsistent with data from an earlier 12-month 135 patient clinical
trial.
However,
on November 19, 2007, Amarin announced that analysis of a comprehensive review
of the 12-month data from the U.S. Phase 3 study showed a statistically
significant difference in TMS-4 between the long term AMR101 group (12-month
treatment) and those patients who had switched to AMR101 at
6-months.
In
November 2007, we met with the FDA following the completion of the comprehensive
review of all clinical data for AMR101 in HD. The FDA indicated that one
additional Phase 3 trial demonstrating robust results, in conjunction with the
confirmatory evidence from the existing clinical data, may be sufficient
clinical data to support a New Drug Application.
In 2008,
we also submitted the comprehensive review of all clinical data for AMR101 in HD
to EMEA. In March 2009, we submitted a Marketing Authorization Application (MAA)
to EMEA and in April 2009, we announced that the EMEA accepted our MAA for
review. The Company has received and discussed the Day 120 questions with
EMEA which raise substantial queries on the efficacy of AMR101 in Huntington's
disease. The future of the Huntington's disease program will be determined
by the Company after further discussion with opinion leaders, experts, existing
and prospective partners and EMEA.
EN101
EN101 is
an orally available antisense oligonucleotide, preferentially targeting the
“read-through” or “R” isoform (“AChE-R”) of acetylcholinesterase (“AChE”). The
molecule suppresses the production of the AChE-R protein without the negative
cholinergic effects currently observed with conventional
inhibitors.
Myasthenia
gravis, a debilitating neuromuscular disease, is the first target indication for
which EN101 is undergoing clinical development. A Phase 1b clinical trial was
conducted by Ester in 2002 to assess the safety, efficacy and pharmacokinetics
of oral EN101 in MG patients. In 2004, Ester commenced a Phase 2a dose finding
study in MG patients. In June 2009, Amarin announced top line results
of this study. The primary objective of the exploratory study, for which interim
results had previously been announced, was to assess the efficacy and safety of
three doses of EN101 each given orally once daily for one week in patients with
myasthenia gravis. The final results of the study indicate that 10mg, 20mg and
40mg of EN101 resulted in a statistically significant reduction in Quantitative
Myasthenia Gravis (QMG) score from baseline of 11.8% (p=0.001), 16.8%
(p<0.001) and 20.3% (p<0.001), respectively. Importantly, EN101 was also
shown to be safe and well tolerated.
The
31-patient study was performed in six centers in the U.K., Israel and Serbia.
Each dose of EN101 was administered to patients for one week and was separated
by a one week wash-out on pyridostigmine, often the first-line treatment for
myasthenia gravis. Efficacy was assessed by evaluating changes in the QMG score,
an established questionnaire that evaluates signs and symptoms of myasthenia
gravis.
In June
2009, Amarin amended the Ester Neurosciences Limited (“Ester”) acquisition
agreement entered into in December 2007. The amendment, which reflects Amarin’s
intention to seek a partner for EN101, provides for the release of Amarin from
all research and development diligence obligations contained in the original
agreement, with all remaining payment obligations now payable by Amarin only out
of income received from potential partners. As part of the amendment and
waiver agreement, in August 2009, Amarin issued 1,315,789 shares to the
former Ester shareholders.
Sublingual
Apomorphine for Parkinson’s Disease
Our novel
sublingual (under the tongue) formulation of Apomorphine aims to achieve rapid
absorption directly into the bloodstream after sublingual administration.
Apomorphine is a particularly effective for the treatment of “off” episodes in
Parkinson’s disease patients. This novel formulation would offer patients a more
user friendly alternative to the currently available injectable formulation of
Apomorphine and we believe, could result in higher rates of
utilization.
Amarin
has successfully progressed its sublingual apomorphine candidate through a
series of Phase 1 pharmacokinetic studies to prove the concept and to optimize
the formulation. The results to date show that Amarin’s sublingual formulation
has the same speed of absorption as the injection formulation and a profile that
supports its further development for the intended indication.
Targeted
Lipid Transport Technology (“TLT”) Platform (previously Combinatorial
Lipids)
We have
researched and patented how to use different types of chemical linkage to attach
a range of bioactive lipids either to other lipids or other drugs. The results
are novel single chemical entities with predictable properties, potentially
offering substantial and clinically relevant advantages over either compound
alone.
This
technology has application across a broad range of therapeutic areas including
CNS, cardiovascular, gastrointestinal and oncology. AMR103, a novel form of
levodopa at pre−clinical stage of development for Parkinson’s disease, is the
lead candidate utilizing this technology.
Manufacturing
and Supply for AMR101
All
supplies of the bulk compound (ethyl-EPA), which constitutes the only
pharmaceutically active ingredient of AMR101, are currently purchased from
Nisshin Pharma, Inc., a currently qualified manufacturer, pursuant to a supply
agreement whereby the supply is at a fixed price. The main raw material that
constitutes ethyl-EPA is a naturally occurring substance which is sourced from
fish oil. The manufacturing processes that are applied by Nisshin to such raw
material are proprietary to Nisshin and produce a pharmaceutical grade compound
at a level of purity of at least 96% EPA. We are aware that certain other
manufacturers have the ability to produce ethyl-EPA to a similar level of
purity.
Our
Marketing Partners for AMR101
AMR101
for HD has been partnered in the major E.U. markets with Scil Biomedical GmbH,
Juste S.A.Q.F. and Archimedes Pharma Ltd.
Additionally,
we are party to a license agreement dated July 21, 2003 with a marketing partner
in Japan to develop, use, offer to sell, sell and distribute products in Japan
utilizing certain of our intellectual property in the pharmaceutical fields of
HD, depression, schizophrenia, dementia and certain less significant indications
(by patient population) including the ataxias, for a period of 10 years from the
date of first commercial sale or, if later, until patent protection
expires.
In
December 2005, Amarin Neuroscience entered into a worldwide exclusive license
with Multicell Technologies, Inc. (“Multicell”) pursuant to which Amarin
Neuroscience licensed the worldwide rights for MCT−125 to Multicell in return
for a series of development based milestones and a royalty on net sales.
Multicell is obliged to use reasonable good faith efforts to develop and
commercialize MCT−125.
The
Financial Year
We had no
revenues in 2008 or 2007. Our consolidated revenues in 2006 comprise milestone
payments received from Multicell and were derived from the licensing of
exclusive, worldwide rights to Multicell for MCT-125 (formerly
LAX-202).
For the
year ended December 31, 2006, all revenues originated in the United Kingdom. No
revenues were generated from licensing, development or contract manufacturing
fees.
At
present all of our products are in the development stage and we therefore have
no products that can be marketed.
Competition
We expect
to compete with other pharmaceutical companies that also conduct research and
development and may compete with these companies to secure sales and marketing
partners for our development pipeline. These anticipated competitors include
companies which may possess substantially greater financial, technical,
marketing and other resources. In addition, we will compete for supplier
manufacturing capacity with other companies, including those whose products are
competing with ours. Additionally, our future products may be subject to
competition from products with similar qualities. See Item 3 “Key Information —
Risk Factors — Our future products may not be able to compete effectively
against those of our competitors.”
Government
Regulation
Any
product development activities relative to AMR101 or products that we may
develop or acquire in the future will be subject to extensive regulation by
various government authorities, including the FDA and comparable regulatory
authorities in other countries, which regulate the design, research, clinical
and non-clinical development, testing, manufacturing, storage, distribution,
import, export, labeling, advertising and marketing of pharmaceutical products
and devices. Generally, before a new drug can be sold, considerable data
demonstrating its quality, safety and efficacy must be obtained, organized into
a format specific to each regulatory authority, submitted for review and
approved by the regulatory authority. The data are generated in two distinct
development stages: pre-clinical and clinical. For new chemical entities, the
pre-clinical development stage generally involves synthesizing the active
component, developing the formulation and determining the manufacturing process,
as well as carrying out non-human toxicology, pharmacology and drug metabolism
studies which support subsequent clinical testing. For established molecules
this stage can be limited to formulation and manufacturing process development
and in vitro studies to support subsequent clinical evaluation.
The
clinical stage of development can generally be divided into Phase 1, Phase 2 and
Phase 3 clinical trials. In Phase 1, generally, a small number of healthy
volunteers are initially exposed to a single dose and then multiple doses of the
product candidate. The primary purpose of these studies is to assess the
metabolism, pharmacologic action, side effect tolerability and safety of the
drug. Studies in volunteers are also undertaken to begin assessing the
pharmacokinetics of the drug (e.g. the way in which the body deals with the
compound from absorption, to distribution in tissues, to
elimination).
Phase 2
trials typically involve studies in disease-affected patients to determine the
dose required to produce the desired benefits. At the same time, safety and
further pharmacokinetic and pharmacodynamic information is collected. Phase 3
trials generally involve large numbers of patients from a number of different
sites, which may be in one country or in several different countries or
continents. Such trials are designed to provide the pivotal data necessary to
establish the effectiveness of the product for its intended use, and its safety
in use, and typically include comparisons with placebo and/or other comparator
treatments. The duration of treatment is often extended to mimic the actual use
of a product during marketing.
Prior to
the start of human clinical studies of a new drug in the United States, an
investigational new drug application, or IND, is filed with the FDA. Similar
filings are required in other countries. The amount of data that must be
supplied in the IND depends on the phase of the study. Earlier investigations,
such as Phase 1 studies, typi-
cally
require less data than the larger and longer-term studies in Phase 3. A clinical
plan must be submitted to the FDA prior to commencement of a clinical trial. In
general, studies may begin in the U.S. 30 days after submission of the
IND. If the FDA has concerns about the clinical plan or the safety of
the proposed studies, they may prevent studies from moving forward, and may
suspend or terminate studies once initiated. Regular reporting of study progress
and adverse experiences is required. During the testing phases, meetings can be
held with the FDA to discuss progress and future requirements for the New Drug
Application (NDA). Studies are also subject to review by independent
institutional review boards responsible for overseeing studies at particular
sites and protecting human research study subjects. An independent institutional
review board may prevent a study from starting or suspend or terminate a study
once initiated. Studies must also be conducted and monitored in accordance with
good clinical practice and other requirements.
Following
the completion of clinical trials, the data must be thoroughly analyzed to
determine if the clinical trials successfully demonstrate safety and efficacy.
If they do, the data can be filed with the FDA in an NDA along with proposed
labeling for the product and information about the manufacturing and testing
processes and facilities that will be used to ensure product quality. In the US,
FDA approval of an NDA must be obtained before marketing a product. The NDA must
contain proof of safety, purity, potency and efficacy, which entails extensive
pre-clinical and clinical testing.
Although
the type of testing and studies required by the FDA does not differ
significantly from those of other countries, the amount of detail required by
the FDA can be more extensive in some areas. In addition, it is likely that the
FDA will re-analyze the clinical data, which could result in extensive
discussions between the Company and the FDA during the review process. The
review and evaluation of applications by the FDA is extensive and time consuming
and may take several years to complete. The FDA’s goal generally is to review
and make a recommendation for approval of a new drug within ten months, and of a
new “priority” drug within six months, although final FDA action on the NDA can
take substantially longer, may entail requests for new data and/or data
analysis, and may involve review and recommendations by an independent FDA
advisory committee. The FDA may conduct a pre-approval inspection of the
manufacturing facilities for the new product to determine whether they comply
with current good manufacturing practice requirements, and may also audit data
from clinical and pre-clinical trials.
There is
no assurance that the FDA will act favorably or quickly in making such reviews
and significant difficulties or costs may be encountered by the Group in its
efforts to obtain FDA approvals. The FDA may also require post-marketing testing
and surveillance to monitor the effects of approved products or it may place
conditions on approvals including potential requirements or risk management
plans that could restrict the commercial promotion, distribution, prescription
or dispensing of products. Product approvals may be withdrawn if compliance with
regulatory standards is not maintained or if problems occur following initial
marketing.
In the
European Union, our future products may also be subject to extensive regulatory
requirements. As in the U.S., the marketing of medicinal products has for many
years been subject to the granting of marketing authorizations by regulatory
agencies. Particular emphasis is also being placed on more sophisticated and
faster procedures for reporting of adverse events to the competent
authorities.
In common
with the U.S., the various phases of pre-clinical and clinical research are
subject to significant regulatory controls. Although the regulatory controls on
clinical research are currently undergoing a harmonization process following the
adoption of the Clinical Trials Directive 2001/20/EC, there are currently
significant variations in the member state regimes. However, all member states
currently require independent institutional review board approval of
interventional clinical trials. With the exception of U.K. Phase 1 studies in
healthy volunteers, all clinical trials require either prior governmental
notification or approval. Most regulators also require the submission of adverse
event reports during a study and a copy of the final study report.
In the
European Union, approval of new medicinal products can be obtained through one
of three processes. The first such process is known as the mutual recognition
procedure. An applicant submits an application in one European Union member
state, known as the reference member state. Once the reference member state has
granted the marketing authorization, the applicant may choose to submit
applications in other concerned member states, requesting them to mutually
recognize the marketing authorizations already granted. Under this mutual
recognition process, authorities in other concerned member states have 55 days
to raise objections, which must then be
resolved
by discussions among the concerned member states, the reference member state and
the applicant within 90 days of the commencement of the mutual recognition
procedure. If any disagreement remains, all considerations by authorities in the
concerned member states are suspended and the disagreement is resolved through
an arbitration process. The mutual recognition procedure results in separate
national marketing authorizations in the reference member state and each
concerned member state.
The
second procedure in the European Union for obtaining approval of new medicinal
product is known as the centralized procedure. This procedure is currently
mandatory for products developed by means of a biotechnological process and
optional for new active substances and other “innovative medicinal products with
novel characteristics.” Under this procedure, an application is submitted to the
European Agency for the Evaluation of Medical Products. Two European Union
member states are appointed to conduct an initial evaluation of each
application. These countries each prepare an assessment report, which reports
are then used as the basis of a scientific opinion of the Committee on
Proprietary Medical Products. If this opinion is favorable, it is sent to the
European Commission which drafts a decision. After consulting with the member
states, the European Commission adopts a decision and grants a marketing
authorization, which is valid throughout the European Union and confers the same
rights and obligations in each of the member states as a marketing authorization
granted by that member state.
The
third, and most recently introduced procedure in the European Union, is known as
the decentralized procedure. This is similar to the mutual recognition procedure
described above, but with some differences: notably in the time key documents
are provided to concerned member states by the reference member state, the
overall timing of the procedure and the possibility of “clock stops” during the
procedure.
The
European Union is currently expanding, with a number of Eastern European
countries joining recently and expected to join over the coming years. Several
other European countries outside the European Union, particularly those
intending to accede to the European Union, accept European Union review and
approval as a basis for their own national approval.
Following
approval of a new product, a pharmaceutical company generally must engage in
various monitoring activities and continue to submit periodic and other reports
to the applicable regulatory agencies, including any cases of adverse events and
appropriate quality control records. Modifications or enhancements to the
products or labeling, or changes of site of manufacture are often subject to the
approval of the FDA and other regulators, which may or may not be received or
may result in a lengthy review process.
Prescription
drug advertising and promotion is subject to federal, state and foreign
regulations. In the U.S., the FDA regulates all company and prescription drug
product promotion, including direct-to-consumer advertising. Promotional
materials for prescription drug products must be submitted to the FDA in
conjunction with their first use. Use of volatile materials may lead to FDA
enforcement actions. Any distribution of prescription drug products and
pharmaceutical samples must comply with the U.S. Prescription Drug Marketing
Act, or the PDMA, a part of the U.S. Federal Food, Drug, and Cosmetic
Act.
In the
U.S., once a product is approved its manufacture is subject to comprehensive and
continuing regulation by the FDA. The FDA regulations require that products be
manufactured in specific approved facilities and in accordance with current good
manufacturing practices, and NDA holders must list their products and register
their manufacturing establishments with the FDA. These regulations also impose
certain organizational, procedural and documentation requirements with respect
to manufacturing and quality assurance activities. NDA holders using contract
manufacturers, laboratories or packagers are responsible for the selection and
monitoring of qualified firms. These firms are subject to inspections by the FDA
at any time, and the discovery of violative conditions could result in
enforcement actions that interrupt the operation of any such facilities or the
ability to distribute products manufactured, processed or tested by
them.
The
distribution of pharmaceutical products is subject to additional requirements
under the PDMA and equivalent laws and regulations in other jurisdictions. For
instance, states are permitted to require registration of distributors who
provide products within their state despite having no place of business within
the state. The PDMA also imposes extensive record-keeping, licensing, storage
and security requirements intended to prevent the unauthorized sale of
pharmaceutical products.
Manufacturing,
sales, promotion, and other activities following product approval are also
subject to regulation by numerous regulatory authorities in addition to the FDA,
including, in the U.S., the Centers for Medicare & Medicaid Services, other
divisions of the Department of Health and Human Services, the Drug Enforcement
Administration, the Consumer Product Safety Commission, the Federal Trade
Commission, and state and local governments. Sales, marketing and
scientific/educational programs must also comply with the U.S. Medicare-Medicaid
Anti-Fraud and Abuse Act and similar state laws. Pricing and rebate programs
must comply with the Medicaid rebate requirements of the U.S. Omnibus Budget
Reconciliation Act of 1990. If products are made available to authorized users
of the Federal Supply Schedule of the General Services Administration,
additional laws and requirements apply. The handling of any controlled
substances must comply with the U.S. Controlled Substances Act and Controlled
Substances Import and Export Act. Products must meet applicable child-resistant
packaging requirements under the U.S. Poison Prevention Packaging Act.
Manufacturing, sales, promotion and other activities are also potentially
subject to federal and state consumer protection and unfair competition
laws.
The
failure to comply with regulatory requirements subjects firms to possible legal
or regulatory action. Depending on the circumstances, failure to meet applicable
regulatory requirements can result in criminal prosecution, fines or other
penalties, injunctions, recall or seizure of products, total or partial
suspension of production, denial or withdrawal of product approvals, or refusal
to allow a firm to enter into supply contracts, including government contracts.
In addition, even if a firm complies with FDA and other requirements, new
information regarding the safety or effectiveness of a product could lead the
FDA to modify or withdraw a product approval. Prohibitions or restrictions on
sales or withdrawal of future products marketed by us could materially affect
our business in an adverse way.
Changes
in regulations or statutes or the interpretation of existing regulations could
impact our business in the future by requiring, for example:
|
·
|
changes
to our manufacturing arrangements;
|
|
·
|
additions
or modifications to product
labeling;
|
|
·
|
the
recall or discontinuation of our products;
or
|
|
·
|
additional
record-keeping requirements.
|
If any
such changes were to be imposed, they could adversely affect the operation of
our business.
Patents
and Proprietary Technology
We are
pursuing New Chemical Entity (NCE) designation for AMR101. This is a
determination that will ultimately be made by the FDA at the time of
approval. NCEs receive 5 years marketing exclusivity under the Drug Price
Competition and Term Restoration act of 1984 (“Waxman-Hatch”). If not
designated an NCE, AMR101 would receive 3 years marketing exclusivity under
Waxman-Hatch. The marketing exclusivity period of 5 or 3 years can be
extended by an additional 6 months by conducting paediatric clinical
studies.
Amarin
has filed six patents in an effort to protect the intellectual property
developed during the AMR101 cardiovascular program. Our patenting strategy
encompasses pursuing patents for compositions, formulations, indications/uses
and combinations with other drugs.
We
believe that patent protection of our technologies, processes and products is
important to our future operations. The success of our products may depend, in
part, upon our ability to obtain strong patent protection. There can however be
no assurance that:
|
·
|
any
additional patents will be issued for AMR101 or any other or future
products in any or all appropriate
jurisdictions;
|
|
·
|
any
patents that we or our licensees may obtain will not be successfully
challenged in the future;
|
|
·
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our
technologies, processes or products will not infringe upon the patents of
third parties; or
|
|
·
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the
scope of any patents will be sufficient to prevent third parties from
developing similar products.
|
When
deemed appropriate, we intend to vigorously enforce our patent protection and
intellectual property rights.
Our
strategy is to file patent applications where we think it is appropriate to
protect and preserve the proprietary technology and inventions considered
significant to our business. We have patents covering our various compounds and
their uses. These include filed and granted composition and use patents for the
method of treating a number of CNS and cardiovascular disorders with highly pure
forms of EPA and composition of matter patents relating to potential second
generation technology platforms. We will also rely upon trade secrets and
know-how to retain our competitive position. We will file patent applications
either on a country-by-country basis or by using the European or international
patent cooperation treaty systems. The existence of a patent in a country may
provide competitive advantages to us when seeking licensees in that country. In
general, patents granted in most European countries have a twenty-year term from
filing, although in certain circumstances the term can be extended by
supplementary protection certificates. We may be dependent in some cases upon
third party licensors to pursue filing, prosecution and maintenance of patent
rights or applications owned or controlled by those parties.
It is
possible that third parties will obtain patents or other proprietary rights that
might be necessary or useful to us. In cases where third parties are first to
invent a particular product or technology, it is possible that those parties
will obtain patents that will be sufficiently broad so as to prevent us from
utilizing such technology. In addition, we may use unpatented proprietary
technology, in which case there would be no assurance that others would not
develop similar technology. See Item 3 “Key Information — Risk Factors — We will
be dependent on patents, proprietary rights and confidentiality, and — Potential
technological changes in our field of business create considerable
uncertainty”.
C. Organizational
Structure
At
December 31, 2008, we had the following subsidiaries:
Subsidiary Name
|
Country
of
Incorporation
or
Registration
|
|
Proportion
of
Ownership
Interest and
Voting
Power Held
|
Amarin
Neuroscience Limited
|
Scotland
|
|
100%
|
Amarin
Pharmaceuticals Ireland Limited
|
Ireland
|
|
100%
|
Amarin
Pharma Inc
|
United
States
|
|
100%
|
Amarin
Finance Limited
|
Bermuda
|
|
100%
|
Ester
Neurosciences Limited
|
Israel
|
|
100%
|
D. Property,
Plant and Equipment
The
following table lists the location, use and ownership interest of our principal
properties as of October 22, 2009:
Location
|
|
|
|
|
|
Dublin,
Ireland
|
Offices
|
|
Leased
|
|
3,251
|
Mystic,
Connecticut, USA
|
Offices
|
|
Leased
|
|
2,725
|
London,
England
|
Offices
|
|
Leased
|
|
2,830
|
Ely,
Cambridgeshire, England
|
|
|
|
|
|
Ground
Floor
|
Offices
|
|
Leased
and sub-let
|
|
7,135
|
First
Floor
|
Offices
|
|
Leased
and sub-let
|
|
2,800
|
Godmanchester,
Cambridgeshire, England
|
Offices
|
|
Leased
and sub-let
|
|
7,000
|
On
November 1, 2008, we signed a lease covering approximate 2,725 square feet of
office space located at 12 Roosevelt Avenue, Mystic, Connecticut, USA. This
lease expires October 31, 2011.
On
January 22, 2007, we signed a lease covering approximately 3,251 square feet of
office space located at 1st Floor, Block 3, The Oval, Shelbourne Road, Dublin 4,
Ireland. This lease expires December 2026; however, it can be terminated in 2012
under a break clause.
We
vacated the premises in Ely, Cambridgeshire in July 2001 and have sub-let the
lease for this space. We have sub-let the lease in Godmanchester to Phytopharm
plc who occupy the premises on a “held over” basis under the terms of a lease,
the term of which expired in January 2002.
On April
27, 2001, we signed a lease covering approximately 2,830 square feet of office
space located at 7 Curzon Street, London, Mayfair, W1J 5HG, England. This lease
expires in March 2010.
We have
no manufacturing capacity at any of the above properties.
Item
4A Unresolved
Staff Comments
None.
Item
5
|
Operating
and Financial Review and Prospects
|
A. Operating
Results
The
following discussion of operating results should be read in conjunction with our
selected financial information set forth in Item 3 “Key Information — Selected
Financial Data” and our consolidated financial statements and notes thereto
beginning on page F-1 of this annual report.
Overview
of Fiscal Years Ended December 31, 2008, December 31, 2007 and December 31,
2006
We have
undergone significant change over the last three years, including the initiation
and progression of our cardiovascular program, completion of a number of CNS
product acquisitions, raising $66.75 million in private equity & debt, the
appointment of a new chief executive officer, restructuring our board and
opening our research and development headquarters in Mystic, Connecticut,
USA.
Pipeline
We are
now focused on developing our lead candidate AMR101 – a prescription grade
Omega-3 fatty acid, which is expected to enter Phase 3 clinical trials for
hypertriglyceridemia and mixed dyslipidemia in Q4 2009. This program leverages
our lipid science expertise, the established safety and tolerability profile of
AMR101 from our previous clinical trials and the known therapeutic benefits of
essential fatty acids, particularly Omega-3s, in treating cardiovascular
disease.
Using our
internal know-how and expertise, we are also investigating a new generation of
lipid compounds, designed to be significantly more potent than currently
available Omega-3 products. We intend to ultimately partner AMR101 for
hypertriglyceridemia and other cardiovascular disease indications with a larger
pharmaceutical company for commercialization worldwide.
We also
intend to partner our CNS pipeline, which includes candidates for Huntington’s
disease, myasthenia gravis and Parkinson’s disease.
October
2009 Financing
On
October 13, 2009, Amarin announced it had entered into definitive agreements
with several existing and new institutional and accredited investors for a
private placement of units for $70 million, consisting of $66.4 million in cash
proceeds and $3.6 million from the conversion of convertible bridge notes. On
closing of the private placement, in consideration for the $66.4 million
received in cash, Amarin issued 66.4 million units. Each unit had a purchase
price of $1.00 and consisted of one American Depositary Share (“ADS”) and a
warrant to purchase 0.50 of an ADS. The warrants will have a five year term and
an exercise price of $1.50 per ADS. In consideration for the conversion of $3.6
million of convertible bridge notes, Amarin issued 4.0 million units. In
accordance with the terms of the conversion of the bridge notes, each unit had a
purchase price of $0.90 and consisted of one ADS and a warrant to purchase 0.50
of an ADS. The warrants will also have a five year term and an exercise price of
$1.50 per ADS.
May
and August 2009 Bridge Financing
In May
2009, Amarin announced that it entered into definitive agreements for a private
placement of convertible bridge loan notes (“Initial Bridge Financing”) in the
amount of $2.6 million with certain existing investors in the Company, including
a number of current directors of the Company. In July 2009, $0.1 million of the
Bridge Financing was repaid. In August 2009, the date of maturity on the
convertible loans was extended to September 30, 2009. In August 2009,
Amarin announced that it had entered into definitive agreements for a private
placement of additional convertible bridge loan notes (“Additional Bridge
Financing”) in the amount of $3.0 million with certain existing investors in the
Company, including a number of current directors of the Company.
The
Initial Bridge Financing and Additional Bridge Financing consist of convertible
notes and warrants. The aggregate convertible notes are in the principal amount
of $5.5 million, were to mature on September 30, 2009 and pay interest at the
rate of 8% per annum. In September 2009, the date of maturity was extended to
October 16, 2009.
On
October 16, 2009, as described above, the holders of $3.6 million convertible
bridge loan notes converted their principal into units and the accrued interest
was repaid in cash. As a result, the Company issued 3,999,996
Ordinary Shares of £0.50 and warrants to purchase 1,999,996 shares with an
exercise price of $1.50.
On
October 16, 2009, the holders of the remaining $1.9 million convertible bridge
loan notes elected to have their principal and accrued interest repaid in
cash.
On July
31, 2009, the Company issued warrants to purchase 3,111,105 shares with an
exercise price of $1.00. These warrants were issued to the holders of
the convertible bridge loan notes in consideration for their participation in
the Bridge Financing. They are in addition to the warrants that were
issued on conversion of the convertible bridge loan notes described
above.
May
2008 Financing
In May
2008 we announced a private placement of Ordinary Shares for up to $60.0 million
under two separate tranches. The first tranche of $30.0 million from
institutional investors and certain current and former directors was received by
the Company in May 2008. In conjunction with the closing of the
private placement described above, the Company has entered into an agreement
with the investors under the previously disclosed Securities Purchase
Agreement dated May 13, 2008, pursuant to which the second tranche funding
option and the preemptive, registration and board seat rights provided by that
agreement will be cancelled and the eight preference shares granted to certain
of the 2008 investors will be converted to eight ordinary shares in Amarin
coincident with the consummation of the financing
Research
and Development Headquarters
In
September 2008, we opened our research & development headquarters in Mystic,
Connecticut. The Mystic office is headed by, Dr. Declan Doogan (who
was appointed to the position of Head of Research and Development in April
2007). Prior to joining Amarin, Dr. Doogan was Senior Vice President and Head of
Worldwide Development at Pfizer Global Research and
Development. Since joining Amarin, Dr. Doogan has been instrumental
in transforming our research and development organization and streamlining
development activities from translational research through clinical
operations.
Board and Management
Changes
On
October 16, 2009, as a result of the financing described above, certain
investors were entitled to join Amarin’s board of directors. On
October 16, Drs. Manus Rogan and Joseph Anderson were appointed to the
board. On the same date Mr. Anthony Russell-Roberts and Drs. John
Climax and William Mason resigned from their positions as non-executive
directors of Amarin Corporation plc.
Mr.
Thomas Lynch, Chairman and Chief Executive Officer of Amarin, will step down as
Chief Executive Officer. Dr. Declan Doogan, Amarin’s Head of Research
and Development, will assume the role of Interim Chief Executive Officer. Mr.
Alan Cooke, President, Chief Operating Officer and Chief Financial Officer will
step down from his position.
In June
2009, Dr. Eric Aguiar resigned from his position as a non-executive director of
Amarin Corporation plc. Dr. Aguiar is currently a partner at Thomas,
McNerney & Partners LP, an investor in Amarin’s May 2008
financing.
In May
2009, Dr. Srinivas Akkaraju resigned from his position as a non-executive
director of Amarin Corporation plc. Dr. Akkaraju recently joined New
Leaf Venture Partners. Dr. Akkaraju was previously at Panorama
Capital, an investor in Amarin’s May 2008 financing.
In May
2008, James I. Healy, M.D., Ph.D., Carl L. Gordon, Ph. D., CFA, Dr. Eric Aguiar
and Dr. Srinivas Akkajaru joined our board of directors. This was as
a result of the May 2008 private equity financing transaction described
above. Dr. Lars Ekman joined our board of directors in November
2008.
The
following directors resigned on May 16, 2008: John Groom, Dr. Simon Kukes, Dr.
Michael Walsh, Dr. Prem Lachman and Prof. William Hall. Alan Cooke
and Dr. Doogan also resigned their board positions but remain in their executive
roles and as officers of the Company.
On
December, 19, 2007, Mr. Thomas Lynch was appointed Chief Executive Officer
following the resignation of Mr. Richard Stewart. Mr. Lynch joined us
in January 2000 as Chairman of the Board. Between 1993 and 2004, Mr.
Lynch was with Elan Corporation plc where he held a number of positions
including Chief Financial Officer and Executive Vice Chairman. Also
on December 19, 2007, Mr. Alan Cooke was appointed to the position of President
and Chief Operating Officer.
Comparison
of Fiscal Years Ended December 31, 2008 and December 31, 2007
Revenue
We
recorded no revenue in 2008 or 2007.
Research
and Development
Research
and Development costs reflect third party contract costs, staff costs,
preclinical study costs, clinical supplies and the cost of conducting clinical
trials. Research and development expense increased by $0.85 million to $12.95
million compared to 2007’s research and development expense of $12.1
million.
The
primary driver of research and development costs in 2008 was the progression of
our cardiovascular program. We also incurred costs in respect of our
CNS products, especially EN101 for myasthenia gravis.
Included
in research and development costs for the year end December 31, 2008 are costs
associated with the set up and recruitment of key employees for our Mystic
office in Connecticut, closure and wind up costs in respect of our Oxford
facility and a non cash charge of $1.5 million in respect of share based
compensation.
Costs in
2007 were primarily driven by the completion of the AMR101 trials into
Huntington’s disease and the initiation of our new cardiovascular
strategy.
In 2009,
Amarin’s focus will be the progression of AMR101 through Phase 3 trials for
hypertriglyceridemia and mixed dyslipidemia. We expect that this will
be the primary driver of research and development costs in 2009.
General
and Administrative
General
and administrative expenses were $15.2 million in 2008 compared with $19.8
million in 2007, a decrease of $4.6 million. General and administrative expenses
primarily represent our general corporate overhead, business and corporate
development costs and our substantial investment in intellectual
property. General and administration costs in 2008 include a
provision of $0.5 million for an onerous lease on our leased property at Gemini
House for the period to the termination of the lease and $0.6 million redundancy
costs for former employees offset by a release of an over-accrual on staff
compensation of $0.8 million and a foreign exchange gain of $1.1 million arising
on non-dollar denominated working capital. Selling, general and administrative
costs primarily represent Amarin’s general corporate overhead, the Company’s
substantial investment in intellectual property and the business and corporate
development costs of pursuing its growth strategy.
The
decrease in general and administrative expenses for the year ended December 31,
2008 compared to the year ended December 31, 2007 is primarily as a result of
the cost rationalization program initiated in early 2008 that reduced personnel,
facility costs and advisor fees.
Finance
income
Finance
income for 2008 was $9.6 million compared to $2.3 million for
2007. The 2008 finance income comprises interest and similar income
of $0.4 million which was earned from cash balances held on
deposit. We hold cash denominated in pounds sterling, U.S. Dollars
and euro. We manage foreign exchange risk by holding our cash in the
currencies in which we expect to incur future cash outflows. In 2008,
a gain of $9.3 million was recorded due to a decrease in the fair value of
derivative financial liabilities in connection with warrants issued in the
December 2007 registered direct offering and a derivative arising on the option
of investors in the May 2008 financing to participate in a second tranche under
that financing. See note 10 to the F-pages in this annual report for further
information.
Finance
costs
Finance
costs for 2008 were $2.1 million compared to $0.2 million for
2007. Finance costs in 2008 comprises $1.0 million of foreign
exchange losses on sterling cash balances due to the strengthening of the dollar
against sterling in the period and $0.3 million of foreign exchange losses on
euro cash balances due to the strengthening of the dollar against euro in the
period. Amarin holds some of its cash in sterling and euro to fund
our expenditures in the U.K. and EU and thus has no plans to convert it into
dollars. Amarin manages foreign exchange risk by holding its cash in the
currencies in which the Company expects to incur future cash outflows. The
finance cost also includes $0.8 million relating to interest and notional
interest on the fair value of the convertible debentures from December 31, 2007
to May 29, 2008, the date of redemption. See note 11 to the F-pages in this
annual report for further information. Finance costs in 2007 relate to interest
and notional interest on the fair value of the convertible debentures issued in
December 2007.
Taxation
A
research and development tax credit of $0.7 million was recognized in the year
ended December 31, 2008. An amount of $0.8 million was recognized in
2007. Under U.K. tax law, qualifying companies can surrender part of
their tax losses in return for a cash refund.
Comparison
of Fiscal Years Ended December 31, 2007 and December 31, 2006
Revenue
We
recorded no revenue in 2007. During 2006, we earned milestone revenue
of $0.5 million under a license agreement signed with Multicell in 2005,
pursuant to which we granted the exclusive, worldwide rights to LAX-202 (renamed
MCT-125) for the treatment of fatigue in patients suffering from multiple
sclerosis.
Research
and Development
The U.S.
and E.U. AMR101 trials into Huntington’s disease were completed in the first
quarter of 2007 with final data announced in April 2007. Research and
development expense decreased by $3.0 million to $12.1 million compared to
2006’s research and development expense of $15.1 million. The
completion of the AMR101 trials into Huntington’s disease was the primary reason
for the fall in research and development expense in 2007. The
decrease in research and development expense was partly offset by costs incurred
on our two Parkinson’s disease programs, our epilepsy programs and the
initiation of our new cardiovascular program.
General
and Administrative
General
and administrative expenses were $19.8 million in 2007 compared with $13.5
million in 2006, an increase of $6.3 million. The increase in general
and administrative expenses over 2006 is mainly due to an increase in share
based compensation expenses of $2.8 million, reorganization costs associated
with the departure of our former chief executive officer and the planned
vacation of our offices in London, increased personnel costs and the significant
level of business development activities during the year.
Finance
income
Finance
income for 2007 was $2.3 million compared to $3.3 million for
2006. The 2007 finance income comprises interest and similar income
of $1.3 million which was earned from cash balances held on
deposit. We hold cash denominated in pounds sterling, U.S. Dollars
and euro. In 2007, a gain of $0.6 million was recorded from holding
pounds sterling and euro as the U.S. Dollar weakened relative to both
currencies, compared to a $2.0 million gain in 2006. We manage
foreign exchange risk by holding our cash in the currencies in which we expect
to incur future cash outflows. In 2007, a gain of $0.4 million was
recorded due to a decrease in the fair value of derivative financial liabilities
in connection with warrants issued in the December 2007 registered direct
offering.
Finance
costs
Finance
costs for 2007 were $0.2 million compared to $2.8 million for
2006. Finance costs in 2007 relate to the fair value of interest
expense on the convertible debentures issued in December
2007. Finance costs for 2006 relate to the future investment right
which was granted under the May 2005 financing. The future investment
right was settled in March 2006. A charge of approximately $2.8
million was recorded in 2006, being the movement in the fair value of the future
investment right from January 1, 2006 to March 15, 2006.
Taxation
A
research and development tax credit of $0.8 million was recognized in the year
ended December 31, 2007. An amount of $0.8 million was also
recognized in 2006. Under U.K. tax law, qualifying companies can
surrender part of their tax losses in return for a cash refund.
Critical
Accounting Policies
Our
significant accounting policies are described in Note 2 to the consolidated
financial statements beginning on page F-1 of this annual report. Our
consolidated financial statements are presented in accordance with IFRS as
adopted by the E.U. and as issued by the IASB. All professional
accounting standards effective as of December
31, 2008
have been taken into consideration in preparing the consolidated financial
statements. These accounting principles require us to make certain
estimates, judgments and assumptions.
We
believe that the estimates, judgments and assumptions upon which we rely are
reasonable based upon information available to us at the time these estimates,
judgments and assumptions are made. These estimates, judgments and
assumptions can affect the reported amounts of assets and liabilities as of the
date of our consolidated financial statements, as well as the reported amounts
of revenues and expenses during the periods presented. To the extent
there are material differences between these estimates, judgments or assumptions
and actual results, our financial statements will be affected. The
significant accounting policies that we believe are the most critical to aid in
fully understanding and evaluating our reported financial results include the
following:
|
·
|
intangible
assets and research and development
expenditure;
|
|
·
|
impairment
of intangible assets; and
|
|
·
|
derivative
financial liabilities.
|
Intangible
assets and research and development expenditure
In-process
research and development
Acquired
in-process research and development (“IPR&D”) is stated at cost less
accumulated amortization and impairments. Acquired IPR&D arising
on acquisitions is capitalized and amortized on a straight-line basis over its
estimated useful economic life, which is the patent life of the intangible
asset. The useful economic life commences upon generation of economic
benefits relating to the acquired IPR&D.
Cost is
defined as the amount of cash or cash equivalents paid, or the fair value of
other consideration given. When IPR&D is acquired and the
consideration is settled using the company’s equity instruments, the IPR&D
is stated at fair value at the date of acquisition. In cases where
the fair value of the IPR&D acquired cannot be measured reliably, the fair
value capitalized at the date of acquisition is measured by reference to the
fair value of the equity instruments granted as consideration.
Capitalization
policy
Costs
incurred on development projects (relating to the design and testing of new or
improved products) are recognized as intangible assets when the following
criteria are fulfilled: completing the asset so it will be available
for use or sale is technically feasible; management intends to complete the
intangible asset and use or sell it; an ability to use or sell the intangible
asset; it can be demonstrated how the intangible asset will generate probable
future economic benefits; adequate technical, financial and other resources to
complete the development and to use or sell the intangible asset are available;
and the expenditure attributable to the intangible asset during its development
can be reliably measured. To date, development expenditures have not
met the criteria for recognition of an internally generated intangible
asset.
Intangible
assets not yet available for use are not subject to amortization but are tested
for impairment at least annually. An impairment loss is recognized if
the carrying amount of an asset exceeds its recoverable amount. The
recoverable amount is the higher of an asset’s fair value less costs to sell and
value in use. Value in use is calculated by discounting the expected
future cash flows obtainable as a result of the asset’s continued
use.
Research
and development expenditure
On an
ongoing basis the Group undertakes research and development, including clinical
trials to establish and provide evidence of product
efficacy. Clinical trial costs are expensed to the income statement
on a systematic basis over the estimated life of trials to ensure the costs
charged reflect the research and development activity performed. To
date, all research and development costs have been written off as incurred and
are included within operating expenses, as disclosed in Note
7. Research and development costs include staff costs, professional
and contractor fees, inventory, and external services.
Foreign
currency
Functional
and presentation currencies
Items
included in the financial statements of each of the Group’s entities are
measured using the currency of the primary economic environment in which the
entity operates (“the functional currency”). The Consolidated
Financial Statements are presented in U.S. Dollars, which is the Parent
Company’s functional and presentation currency.
Transactions
and balances
Transactions
in foreign currencies are recorded at the average exchange rate prevailing in
the month of the transaction. The resulting monetary assets and
liabilities are translated into the appropriate functional currency at exchange
rates prevailing at the balance sheet date and the resulting gains and losses
are recognized in the income statement. Foreign exchange gains and
losses resulting from the settlement of such transactions are recognized in the
income statement.
Group
companies
The
results and financial position of all the Group entities (none of which has the
currency of a hyper-inflationary economy) that have a functional currency
different from the presentation currency are translated into the presentation
currency as follows:
|
(i) |
assets and
liabilities for each balance sheet presented are translated at the closing
rate at the date of that balance sheet; |
|
(ii) |
income and
expenses for each income statement are translated at average exchange
rates (unless this average is not a reasonable approximation of the
cumulative effect of the rates prevailing on the transaction
dates, in which case income and expenses are translated at the rate on the
dates of the transactions); and |
|
(iii) |
all resulting
exchange differences are recognized as a separate component of
equity. |
Monetary
items that are receivable or payable to a foreign operation are treated as a net
investment in the foreign operation by the Company as settlement is neither
planned nor likely to occur in the foreseeable future. On
consolidation, exchange differences arising from the translation of the net
investment in foreign operations, and of borrowings and other currency
instruments designated as hedges of such investments, are taken to
equity. When a foreign operation is partially disposed of or sold,
exchange differences that were recorded in equity are recognized in the income
statement as part of the gain or loss on sale.
Fair
value adjustments arising on the acquisition of a foreign entity are treated as
assets and liabilities of the foreign entity and translated at the closing
rate.
Revenue
Revenue
from technology licensing to third parties is recognized when earned and
non-refundable, through the achievement of specific milestones set forth in the
applicable contract, when there is no future obligation with respect to the
revenue and receipt of the consideration is probable, in accordance with the
terms prescribed in the applicable contract.
Impairment
of intangible assets
Intangible
assets with an indefinite life and intangible assets not yet available for use
are not subject to amortization but are tested for impairment
annually. Additionally, assets subject to amortization are reviewed
for impairment whenever events or changes in circumstances indicate that the
carrying amount may not be recoverable. The recoverable amount is the
higher of an asset’s fair value less costs to sell and value in
use. Value in use is calculated by discounting the expected future
cash flows obtainable as a result of the asset’s continued use. For
the
purposes
of impairment, assets are grouped into cash-generating units and an impairment
charge is recognized whenever the carrying amount of an asset or its
cash-generating unit exceeds its recoverable amount.
A
cash-generating unit is the smallest identifiable asset group that generates
cash flows that largely are independent from other assets and
groups. Impairment losses are recognized in the income
statement. Impairment losses recognized in respect of cash-generating
units are allocated to reduce assets in the unit (group of units) on a pro-rata
basis.
An
impairment loss may be reversed to the extent that the asset’s original carrying
amount does not exceed the carrying amount that would have been determined, net
of depreciation or amortization, if no impairment loss had been
recognized. Non-financial assets that suffer impairment are reviewed
for possible reversal of the impairment at each reporting date.
See note
16 to the F-pages of this Annual Report for further information.
Derivative
financial liabilities
Issued
financial liabilities or their components are classified as derivative financial
liabilities where the substance of the contractual arrangement results in the
Group having a present obligation to either deliver cash or another financial
asset to the holder, to exchange financial instruments on terms that are
potentially unfavorable or to satisfy the obligation otherwise than by the
exchange of a fixed amount of cash or another financial asset for a fixed number
of shares.
Derivative
financial liabilities on initial recognition are recorded at fair value, being
the fair value of consideration received. They are subsequently held
at fair value, with gains and losses arising for changes in fair value
recognized in the income statement at each period end. The Group
derecognizes the derivative financial liability, and recognizes a gain in the
income statement when its contractual obligations are cancelled or
expired. If the Group issues shares to discharge the liability, the
derivative financial liability is derecognized and share premium is recognized
on the issuance of those shares.
Where the
options and warrants give rise to obligations to issue ordinary shares other
than on the above basis they are classified as financial liabilities on the
balance sheet. Where these instruments meet the definition of
derivatives they are included at fair value on the balance sheet at each
reporting year end, with the resulting unrealized gains or losses being recorded
in the income statement.
In both
situations, at settlement date the carrying value of the options and warrants
are transferred to equity. The cash proceeds received from
shareholders for additional shares are recorded in the share capital and share
premium account.
Critical
Accounting Estimates and Assumptions
The Group
makes estimates and assumptions concerning the future. The resulting
accounting estimates will, by definition, seldom equal the related actual
results. The estimates and assumptions that have a significant risk
of causing a material adjustment to the carrying amounts of assets and
liabilities within the next financial year are discussed below.
Carrying
value of intangible assets
Intangible
assets relate to the asset acquisition of Ester Neurosciences Limited on
December 5, 2007. The carrying value of the intangible asset
comprises Amarin Common Stock issued, cash paid and Amarin Common Stock to be
issued under the achievement of certain milestones.
The Group
reviews intangible assets not yet available for use for impairment at least
annually. An impairment loss is recognized if the carrying amount of
an asset exceeds its recoverable amount. The recoverable amount of an
intangible asset is determined by discounting the expected future cash
flows. The Group uses significant assumptions and estimates in
determining an intangible assets recoverable amount.
Intangible
assets not yet available for use (i.e. EN101) are not subject to amortization
but are tested for impairment at least annually. An impairment loss
is recognized if the carrying amount of the asset exceeds its recoverable
amount. The recoverable amount is determined using a value in use
methodology which is arrived at by discounting the expected future cash flows of
the intangible asset. These cash flows, which reflect the risks and
uncertainties associated with the assets, are then discounted at an appropriate
rate to net present value.
Net
present values involve highly sensitive estimates and assumptions specific to
the nature of our activities with regard to:
|
·
|
The
amount and timing of projected future cash
flows;
|
|
·
|
The
selected discount and tax rate;
|
|
·
|
The
outcome of R&D activities (compound efficacy, results of clinical
trials, etc.);
|
|
·
|
The
amount and timing of projected costs to develop EN101 into commercially
viable products;
|
|
·
|
The
probability of obtaining regulatory
approval;
|
|
·
|
Long-term
sales forecasts; and
|
|
·
|
Sales
erosion rates after the end of patent protection and timing of the entry
of generic competition.
|
Factors
that could result in shortened useful lives or impairments include:
|
·
|
Negative
outcome from research and development activities with
EN101;
|
|
·
|
Failure
to obtain regulatory approval;
|
|
·
·
|
Failure
to secure a development and marketing partner;
Failure to maintain a license from the licensor;
and
|
|
·
|
Lower
than anticipated future sales for
EN101.
|
We have
adopted a uniform method for assessing EN101. Typically three
probability-weighted scenarios are used, which reflect the risks and
uncertainties associated with the asset.
Discount
rates used in these scenarios are based on our weighted average cost of capital,
which are then probability adjusted to reflect specific risks associated with
our industry.
Due to
the above factors, actual cash flows and values could vary significantly from
the forecasted future cash flows and related values derived using discounting
techniques. Key assumptions include:
Discount
rate
|
15%
|
Probability
of success
|
15
to 30%
|
Peak
penetration rate
|
49%
|
Population
Growth rate
|
0.4%
to 0.6%
|
Prevalence
|
14/100,000
|
Discount
rate is based on the weighted average cost of capital to Amarin. Probability of
success is based on management’s best estimate of the likelihood that the
product will achieve FDA approval, based on the results of its exploratory Phase
IIa trial. Peak penetration rate has been estimated using management’s knowledge
of the industry and the attributes of the product and alternative treatments on
the market.
Population
growth and prevalence are based on industry information.
Fair
value of derivatives and other financial instruments
Derivative financial liabilities are
recorded at fair value on initial recognition, being the fair value of
consideration received. They are subsequently held at fair value,
with gains and losses arising for changes in fair value recognized in the income
statement at each period end. The fair value of
derivative financial liabilities is determined using valuation techniques. The
Group uses its judgment to select a variety of methods and make assumptions that
are mainly based on market conditions existing at each balance sheet date. See
notes 24 and 29 for further information on our valuation techniques and
assumptions in fair valuing the Group’s derivative financial
liabilities.
Carrying
value of investment in subsidiaries
The
carrying value of the Company’s investment in subsidiaries is tested when there
is an indication of impairment. The Company uses the present value of
future cash flows of their products to determine whether an impairment provision
is required. These cash flows assume the Company’s products will be
approved by the FDA and will be capable of generating
revenues. Management judgment is required in forecasting the cash
flows of each product and these cash flows are adjusted for industry probability
factors and the Group discount rate. During 2007, the Company provided for
approximately $4.6 million for impairment on AMR101 for HD related
investments.
Going
concern
See note
1 to the F-pages in this annual report for further information.
Share
based payments
The Group
operates an equity-settled, share based compensation plan. The fair
value of the employee services received in exchange for the grant of the options
is recognized as an expense. The total amount to be expensed over the
vesting period is determined by reference to the fair value of the options
granted, excluding the impact of any non-market vesting
conditions. Non-market vesting conditions are included in assumptions
about the number of options that are expected to vest. At each
balance sheet date, the entity revises its estimates of the number of options
that are expected to vest. It recognizes the impact of the revision
to original estimates, if any, in the income statement, with a corresponding
adjustment to equity.
When the
Group modifies share options and the fair value of the options granted
increases, the incremental fair value granted is recognized over the remaining
vesting period. The incremental fair value is calculated as the
difference between the fair value of the modified option and that of the
original option, both estimated at the date of the modification.
The
proceeds received net of any directly attributable transaction costs are
credited to share capital (nominal value) and share premium when the options are
exercised.
The grant
by the Company of options over its equity instruments to the employees of
subsidiary undertakings is treated as a capital contribution in the books of the
subsidiary. The fair value of employee services received by the
subsidiary, measured by reference to the grant date fair value, is recognized
over the vesting period as an increase to investment in subsidiary undertakings,
with a corresponding credit to equity.
Provision
is made for employer’s National Insurance and similar taxes that arise on the
exercise of certain share options, calculated using the market price at the
balance sheet date.
In
transactions where the Group receives goods and services from non-employees in
exchange for its equity instruments, the corresponding increase in equity is
measured at the fair value of the goods and services received.
See note
30 to the F-pages of this Annual Report for further
information.
Deferred
tax assets
A
deferred tax asset is recognized only to the extent that it is probable that
future taxable profits will be available against which the temporary differences
can be utilized.
No
deferred tax asset or liability is recognized in respect of temporary
differences associated with investments in subsidiaries where the Group is able
to control the timing of reversals of the temporary differences and it is
probable that the temporary differences will not reverse in the foreseeable
future.
See note
13 to the F-pages in this annual report for further information.
Impact
of Inflation
Although
our operations are influenced by general economic trends, we do not believe that
inflation had a material impact on our operations for the periods
presented.
Foreign
Currency
The U.S.
Dollar is the functional currency for the Company. A percentage of
our expenses, assets and liabilities are denominated in currencies other than
our functional currency. Fluctuations in exchange rates may have a
material adverse effect on our consolidated results of operations and could also
result in exchange gains and losses. We cannot accurately predict the
impact of future exchange rate fluctuations on our consolidated results of
operations. We aim to minimize our foreign currency risk by holding
cash balances in the currencies in which we expect to incur future cash
outflows.
Governmental
Policies
We are
not aware of any governmental, economic, fiscal, monetary or political policies
that have materially affected or could materially affect, directly or
indirectly, our operations or investments by U.S. shareholders.
B. Liquidity
and Capital Resources
Our
capital requirements relate primarily to clinical trials, employee
infrastructure and working capital requirements. Historically, we
have funded our cash requirements primarily through the public and private sales
of equity and debt securities. As of December 31, 2008, we had
approximately $14.2 million in cash ($3.0 million related to cash held on
short-term deposits), representing a decrease of $4.1 million compared to
December 31, 2007. In May 2008 we announced a private placement of
Ordinary Shares for up to $60.0 million under two separate
tranches. The first tranche of $30.0 million from institutional
investors and certain current and former directors was received in May
2008. The option to invest the second tranche of $30 million was
cancelled on the closing of the $70 million financing in October
2009.
On
October 13, 2009, Amarin announced it had entered into definitive agreements
with several existing and new institutional and accredited investors for a
private placement of units for $70 million, consisting of $66.4 million in cash
proceeds and $3.6 million from the conversion of convertible bridge notes. On
closing of the private placement, in consideration for the $66.4 million
received in cash, Amarin issued 66.4 million units. Each unit had a purchase
price of $1.00 and consisted of one American Depositary Share (“ADS”) and a
warrant to purchase 0.50 of an ADS. The warrants will have a five year term and
an exercise price of $1.50 per ADS. In consideration for the conversion of $3.6
million of convertible bridge notes, Amarin issued 4.0 million units. In
accordance with the terms of the conversion of the bridge notes, each unit had a
purchase price of $0.90 and consisted of one ADS and a warrant to purchase 0.50
of an ADS. The warrants will also have a five year term and an exercise price of
$1.50 per ADS.
In May
2009, Amarin announced that it entered into definitive agreements for a private
placement of convertible bridge loan notes (“Initial Bridge Financing”) in the
amount of $2.6 million with certain existing investors in the Company, including
a number of current directors of the Company. In July 2009, $0.1 million of the
Bridge Financing was repaid. In August 2009, the date of maturity on the
convertible loans was extended to September 30, 2009. In August 2009,
Amarin announced that it had entered into definitive agreements for a private
place-
ment of
additional convertible bridge loan notes (“Additional Bridge Financing”) in the
amount of $3.0 million with certain existing investors in the Company, including
a number of current directors of the Company.
The
Initial Bridge Financing and Additional Bridge Financing consist of convertible
notes and warrants. The aggregate convertible notes are in the principal amount
of $5.5 million, were to mature on September 30, 2009 and pay interest at the
rate of 8% per annum. In September 2009, the date of maturity was extended to
October 16, 2009.
On
October 16, 2009, as described above, the holders of $3.6 million convertible
bridge loan notes converted their principal into units and the accrued interest
was repaid in cash. As a result, the Company issued 3,999,996
Ordinary Shares of £0.50 and warrants to purchase 1,999,996 shares with an
exercise price of $1.50.
On
October 16, 2009, the holders of the remaining $1.9 million convertible bridge
loan notes elected to have their principal and accrued interest repaid in
cash.
On July
31, 2009, the Company issued warrants to purchase 3,111,105 shares with an
exercise price of $1.00. These warrants were issued to the holders of
the convertible bridge loan notes in consideration for their participation in
the Bridge Financing. They are in addition to the warrants that were
issued on conversion of the convertible bridge loan notes described
above.
Based
upon current business activities, we forecast having sufficient cash to fund
operations for at least the next 12 months from October
22, 2009.
Over the
three years ended December 31, 2008, we received $64.0 million in cash from the
issuance of shares and $2.75 million in convertible Debentures. The convertible
Debentures were redeemed in full on May 29, 2008.
Cash
As of
December 31, 2008, we had approximately $14.2 million in cash compared with
$18.3 million as of December 31, 2007. Our cash has been invested
primarily in U.S. Dollar, pounds sterling and euro denominated money market and
checking accounts with financial institutions in the U.K., U.S., Ireland and
Israel, predominately having a high credit standing. Due to current economic
conditions the credit ratings of financial institutions have been extremely
volatile. Management believes that the financial institutions where we hold our
cash deposits are of a high and acceptable credit rating, given current economic
conditions.
Cash
flows expended on operating activities were $26.4 million for the year ended
December 31, 2008 as compared with $26.3 million for the year ended December 31,
2007.
The
operating cash flows expended on operating activities reflect funding of the net
loss of $20.0 million adjusted for non-cash depreciation of $0.3 million,
non-cash inflow in respect of share based compensation of $4.6 million, a
non-cash inflow in respect of a fair value gain on derivative financial
liability of $9.3 million, net inflow of interest, foreign exchange and
other items of $0.8 million and net outflow on working capital of $3.6
million.
In 2007,
the operating cash flows expended on operating activities reflect funding of the
net loss of $37.8 million adjusted for a non-cash impairment charge on
intangible assets of $8.8 million, non-cash depreciation and amortization of
$0.4 million, non-cash inflow in respect of share based compensation of $5.3
million, a non-cash inflow in respect of a fair value gain on derivative
financial liability of $0.4 million, net outflow of interest, foreign
exchange and other items of $1.6 million and net outflow on working capital of
$0.8 million.
Cash
outflows expended on investing activities were $0.1 million in 2008. Net cash
inflows expended on investing activities were $5.0 million in
2007. Our investing activities in 2008 related to the purchase of
property, plant and equipment for the set up of the Mystic office and interest
received. We do not envisage significant expenditure on property,
plant and equipment in 2009. Our investing activities in 2007 related
to the purchase of intangible assets, property, plant and equipment and interest
received.
Net cash
flows from financing activities in 2008, net of related expenses were $23.5
million, compared to cash inflows from financing activities in 2007 net of
related expenses of $12.1 million.
Gross
receipts from financing activities in 2008 were $30.0 million. In May 2008 we
announced a private placement of Ordinary Shares for up to $60.0
million. The first tranche of $30.0 million from institutional
investors and certain current and former directors was received in May
2008. Expenses of $3.7 million were for the issuance of shares. On
December 4, 2007, the company entered into an agreement to issue $2.75 million
8% convertible debentures. Under the debenture agreement, mandatory redemption
occurs if a financing takes place. As a result of the May financing we settled
in full the outstanding amount on the convertible debentures.
On May
19, 2008 we accepted subscriptions of $30.0 million from institutional investors
and certain current and former directors, for approximately 13.0 million
Ordinary Shares in the form of ADSs in a private equity placement at a purchase
price of $2.30. The net proceeds of our May private placement (taking
into account professional advisor fees associated with filing the related
registration statement, cash fees of our placement agent and government stamp
duty but not our travel, printing or other expenses) were approximately $26.3
million.
Gross
receipts from financing activities in 2007 comprised two equity financings
yielding $9.1 million, gross proceeds on the issue of convertible debentures
$2.75 million and other warrant and option exercises of $0.6 million, offset by
issuance costs of $0.3 million.
On
December 4, 2007, we accepted subscriptions of $5.4 million from institutional
and other accredited investors for approximately 1.63 million Ordinary Shares in
the form of ADSs in a registered direct offering at a purchase price of $3.30
per share and issued warrants to purchase approximately 0.81 million Ordinary
Shares at an exercise price of $4.80 per share. Per the warrant
agreement, if at any time prior to December 6, 2009, the Company issues Ordinary
Shares, securities convertible into ADSs or Ordinary Shares, warrants to
purchase ADSs or Ordinary Shares or options to purchase any of the foregoing to
a third party (other than any Exempt Issuance) at a price that is less than, or
converts at a price that is less than, $3.66 (such lesser price, the “Down-round
Price”), then the Exercise Price shall be adjusted to equal 130% of the
Down-round Price. In May, 2008, we announced a private placement of
Ordinary Shares for $30.0 million. The private placement from
investors of $30.0 million closed on May 19, 2008 (see note 28 for further
details). These warrants have therefore been re-priced to $2.99 per
share from their original grant price of $4.80 per share. In October 2009, $3.6
million convertible bridge notes converted at $0.90 per share (see note 35 for
further details). These warrants have therefore been re-priced again, to $1.17
per share.
The net
proceeds of our December registered offering (taking into account professional
adviser fees associated with filing the related registration statement, cash
fees of our placement agent and government stamp duty) were approximately $5.1
million.
On June
1, 2007, we issued approximately 0.62 million ordinary shares and warrants to
purchase approximately 0.06 million shares with an exercise price of $7.20 per
share in a registered direct offering, in consideration for $3.7
million.
On
October 23, 2006, we accepted subscriptions of $18.7 million from institutional
and other accredited investors for approximately 0.9 million Ordinary Shares in
the form of ADSs in a registered direct offering at a purchase price of $20.90
per share. The net proceeds of our October registered offering
(taking into account professional advisers’ fees associated with filing the
related registration statement, cash fees of our placement agent and government
stamp duty but not our travel, printing or other expenses) were approximately
$17.3 million.
On March
31, 2006, we issued approximately 0.24 million Ordinary Shares in the form of
ADSs in consideration for $4.2 million raised in a registered direct financing
which was completed pursuant to pre-existing contractual commitments arising
from a previously completed financing in May 2005.
On
January 23, 2006, we issued a total of approximately 0.09 million Ordinary
Shares in the form of ADSs and issued warrants to purchase approximately 0.03
million Ordinary Shares at an exercise price of $30.60 in consideration for $2.1
million raised in the January 23, 2006, private equity
placement.
At
December 31, 2008 and December 31, 2006 we had no debt. At December
31, 2007, we had total debt of $2.75 million with a cash maturity in
2010. In May 2008, this debt was redeemed as part of the May 2008
equity financing.
All
treasury activity is managed by the corporate finance group. Cash
balances are invested in short-term deposits, either U.S. Dollars, pounds
sterling or euro. No formal hedging activities are undertaken as cash
balances are maintained in currencies that match our anticipated financial
obligations and forecast cash flows.
C. Research
and Development
Amarin
has in-house research and development capability and expertise, supplemented by
retained external consultants. Costs classified as research and
development are written off as incurred, as are patent costs. Such
costs include external trial costs, clinical research organization costs, staff
costs, professional and contractor fees, materials and external
services. Details of amounts charged in the three years ended
December 31, 2008, December 31, 2007 and December 31, 2006, are disclosed
above. Specifically, we incurred $12.9 million in 2008. In
2007 and 2006, we incurred costs of $12.1 million and $15.1 million
respectively.
Amarin is
initiating a series of cardiovascular preclinical and clinical programs to
capitalize on the known therapeutic benefits of essential fatty acids in
cardiovascular disease. Amarin’s CNS development pipeline includes
programs in Huntington’s disease, myasthenia gravis and Parkinson’s
disease.
Looking
ahead, our expenditure will be increasingly focused on developing our lead
candidate AMR101 for hypertriglyceridemia and mixed dyslipidemia. We intend to
ultimately partner AMR101 for hypertriglyceridemia and other cardiovascular
disease indications with a larger pharmaceutical company for commercialization
in the United States. We also intend to partner our CNS pipeline, which includes
candidates for Huntington’s disease, myasthenia gravis and Parkinson’s
disease.
D. Trend
Information
In 2004,
we changed our business model and have had no other sources of revenue since
then other than revenue pursuant to our out-licensing contract with
Multicell. Until we are able to market a product or secure revenue
from licensing sources, this trend is expected to continue. We refer
users to Items 4B “Business Overview”, 5A “Operating Results” and 5B “Liquidity
and Capital Resources”.
E. Off
Balance Sheet Transactions
Although
there are no disclosable off balance sheet transactions, there have been
transactions involving contingent milestones — see “Note 32 — Financial
Commitments” in the financial statements.
F. Contractual
Obligations
The
following table summarizes our payment obligations as of December 31,
2008. The operating lease obligations primarily represent rent
payable on properties leased by the Group. Some of the properties
leased by the Group have been sub-let and generate rental
income. Purchase obligations relate to manufacturing contracts with a
third party for the production of our products. Clinical research
obligations relate to clinical development contracts for AMR101 for
hypertriglyceridemia, Huntington’s disease and AAMI.
|
|
Payment
Due By Period in $000’s
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital/finance
lease obligations
|
|
|
36 |
|
|
|
12 |
|
|
|
24 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Operating
lease obligations
|
|
|
2,467 |
|
|
|
929 |
|
|
|
628 |
|
|
|
486 |
|
|
|
161 |
|
|
|
137 |
|
|
|
126 |
|
Clinical
research obligations
|
|
|
1,485 |
|
|
|
1,485 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Purchase
obligations
|
|
|
864 |
|
|
|
864 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Total
|
|
|
4,852 |
|
|
|
3,290 |
|
|
|
652 |
|
|
|
486 |
|
|
|
161 |
|
|
|
137 |
|
|
|
126 |
|
There are
no capital commitments relating to the AMR101 development
project. However, under the purchase agreement for Laxdale, upon the
attainment of specified development milestones, we will be required to issue
additional Ordinary Shares to the selling shareholders or make cash payments (at
the sole option of each of the selling shareholders) and we will be required to
make royalty payments of 8-9% on future revenues of AMR101 booked by Amarin.
This consists of 7% payable to Scarista Limited; 0.5% payable to each of Dr.
Malcolm Peet and Dr. Krishna Vaddadi; and 1% payable to Dr. Mehar Manku (1%
royalty to Dr. Manku is payable only on net sales up to £100 million; royalty
reduces to 0.5% for net sales between £100 million and £500 million; and royalty
reduces to 0.25% for sales in excess of £500 million). The final
purchase price will be a function of the number of Ordinary Shares of Amarin
issued at closing and actual direct acquisition costs, together with contingent
consideration which may become payable, in the future, on the achievement of
certain approval milestones. Upon receipt of marketing approval in
the United States and Europe for the first indication of any product containing
Amarin Neuroscience intellectual property, we must make an aggregate stock or
cash payment (at the sole option of each of the sellers) of GBP£7.5 million for
each of the two potential market approvals (i.e., GBP£15.0 million
maximum). In addition, upon receipt of a marketing approval in the
United States and Europe for any other product using Amarin Neuroscience
intellectual property or for a different indication of a previously approved
product, we must make an aggregate stock or cash payment (at the sole option of
each of the sellers) of GBP£5.0 million for each of the two potential market
approvals (i.e., GBP£10.0 million maximum). The exchange
rate as of October 20, 2009 was approximately $1.6402 per
GBP£.
In June 2009, Amarin has amended the
Ester Neurosciences Limited (“Ester”) acquisition agreement entered into in
December 2007. The amendments, which reflect Amarin’s intention to seek a
partner for EN101, provide for the release of Amarin from all research and
development diligence obligations contained in the original agreement, with all
remaining payment obligations now payable by Amarin only out of income received
from potential partners. As part of the amendment and waiver agreement, in
August 2009, Amarin issued 1,315,789 shares to the former Ester
shareholders.
Item
6 Directors,
Senior Management and Employees
A. Directors
and Senior Management
The
following table sets forth certain information regarding our officers and
directors as of December 31, 2008. A summary of the background and experience of
each of these individuals follows the table.
Name
|
Age
|
Position
|
Thomas
Lynch
|
52
|
Chairman
and Chief Executive Officer
|
Anthony
Russell-Roberts
|
63
|
Non-Executive
Director
|
Dr.
William Mason
|
57
|
Non-Executive
Director
|
Dr.
John Climax
|
56
|
Non-Executive
Director
|
Dr.
James I. Healy
|
44
|
Non-Executive
Director
|
Dr.
Carl L. Gordon
|
44
|
Non-Executive
Director
|
Dr.
Eric Aguiar
|
47
|
Non-Executive
Director
|
Dr.
Srinivas Akkaraju
|
41
|
Non-Executive
Director
|
Dr.
Lars Ekman
|
59
|
Non-Executive
Director
|
Alan
Cooke*
|
38
|
President
and Chief Operating Officer
|
Dr.
Declan Doogan
|
56
|
Head,
Research & Development
|
Tom
Maher
|
42
|
General
Counsel and Company Secretary
|
Conor
Dalton
|
44
|
Vice
President, Finance & Principal Accounting
Officer
|
*
|
Mr.
Cooke also acts as Chief Financial
Officer
|
Mr.
Thomas Lynch joined Amarin in January 2000 as Chairman of the Board. Between
1993 and 2004, Mr. Lynch was with Elan Corporation plc where he held a number of
positions including Chief Financial Officer and Executive Vice Chairman. Mr.
Lynch spear-headed Elan’s transition from a drug delivery technology provider to
a fully integrated pharmaceutical company, through a number of acquisitions,
including Athena Neurosciences, Inc.
The
Athena acquisition brought Elan its programs in multiple sclerosis, autoimmune
diseases and Alzheimer’s disease. Mr. Lynch was also a founder of the specialty
pharmaceutical company, Warner Chilcott plc. Mr. Lynch is and has been a board
member of a number of biotechnology and healthcare companies.
Mr.
Anthony Russell-Roberts joined us as a Non-Executive Director on April 7, 2000.
He has held the position of Administrative Director of The Royal Ballet at the
Royal Opera House since 1983. He retired as director of the Royal Opera House on
March 24, 2009. Prior to that, he was Artistic Administrator of the Paris Opera
from 1981 after five years of work in the lyric arts in various theatres. Mr.
Russell-Roberts’ earlier business career included eight years with Lane Fox and
Partners, as a partner specializing in commercial property development. He holds
an M.A. degree in Politics, Philosophy, and Economics from Oxford University and
was awarded a CBE in 2004.
Dr.
William Mason was appointed Lead independent Director on February 4, 2008. Dr.
Mason has served as a non-executive board member of Amarin since July 19, 2002,
is Chairman of the Company’s Audit Committee and a member of Amarin’s
Nominations Committee. Dr. Mason received his B.Sc. from Case Western Reserve
University in the United States and his doctorate in physiology from Trinity
College, Cambridge, UK in 1977. For twenty years he led a program of
neuroscience-focused medical research in Cambridge. Dr. Mason also played an
active role as a member of the Advisory Council on Science and Technology
(“ACOST”) in the UK Cabinet Office of HM Government, developing government
policy to create a highly qualified scientific and technical manpower base in
the UK. He has founded successful high technology biomedical companies and has
extensive commercial transactional experience in the healthcare and life
sciences sector. He maintains strong links with the healthcare investment
community. Currently, Dr. Mason is Chairman of OrthoMimetics Ltd., Zygem Ltd.,
Camlab Ltd. and Team Consulting Ltd., and is a director of Sage Healthcare Ltd.
and Sphere Medical Ltd. He is also a member of the 3i Independent Director’s
Program.
Dr. John
Climax was appointed a non-executive director of Amarin on March 20, 2006. Dr.
Climax was a founder of Icon plc, serving as a Director and Chief Executive
Officer of Icon and its subsidiaries since June 1990. In November 2002, he was
appointed Executive Chairman. Dr. Climax received his primary degree in pharmacy
in 1977 from the University of Singapore, his masters in applied pharmacology in
1979 from the University of Wales and his PhD in clinical pharmacology from the
National University of Ireland in 1982. Dr. Climax is an adjunct Professor at
the Royal College of Surgeons, Dublin and Chairman of the Human Dignity
Foundation, a Swiss based charity.
James I.
Healy, M.D., Ph.D., joined Amarin as a non-executive director in May 2008. Dr.
Healy joined Sofinnova Ventures as a General Partner in 2000. Dr. Healy was a
founding investor and board member of Cellective (acquired by MedImmune),
CoTherix (acquired by Actelion), Novacea, and Intermune. He also serves on the
boards of directors of several private companies. In the pharmaceutical industry
Dr. Healy held positions at Bayer Pharmaceuticals (Miles) and ISTA
Pharmaceuticals prior to its initial public offering. He began his private
equity career at Sanderling Ventures. Dr. Healy earned B.A.s in Molecular
Biology and Scandinavian Studies from the University of California at Berkeley,
where he graduated with Distinction in General Scholarship, Honors, and received
a Departmental Citation. He received his M.D. from Stanford University’s School
of Medicine through the Medical Scientist Training Program, and earned his Ph.D.
in Immunology from Stanford University, where he was a Beckman Scholar and
received a bursary award from the Novartis Foundation. Dr. Healy teaches a
course on entrepreneurship at Stanford University, and is an active member of
the BIO-NVCA Working Group.
Carl L.
Gordon, Ph. D., CFA, joined Amarin as a non-executive director in May 2008. Dr.
Gordon is a founding General Partner and Co-Head of Private Equity of OrbiMed
Advisors LLC. Dr. Gordon is active in both private equity and
small-capitalization public equity investments. He was a senior biotechnology
analyst at Mehta and Isaly from 1995 to 1997. He was a Fellow at The Rockefeller
University from 1993 to 1995. Dr. Gordon received a Ph.D. in Molecular Biology
from the Massachusetts Institute of Technology. His doctoral work involved
studies of protein folding and assembly. He received a Bachelor’s degree from
Harvard College.
Dr. Eric
Aguiar joined Amarin as a non-executive director in May 2008. Dr. Aguiar is a
Partner at Thomas, McNerney & Partners. He has 16 years of experience in the
biopharmaceutical industry. From 2001 to 2007 he was a Managing Director at
HealthCare Ventures. Prior to joining HealthCare Ventures, he was CEO of Genovo,
Inc. Dr. Aguiar was an executive at TheraTech, a drug delivery company that was
sold to Watson Pharmaceuticals in
1997. He
was a Managing Director and Vice President of Philadelphia Ventures in the
mid-1990’s. Prior board seats have included CardioKine, SkinMedica, Vaxinnate,
Metaphore Pharmaceuticals, 3-D Pharmaceuticals, and ThromboSys. He graduated
from Harvard Medical School and Cornell University with honors.
Dr.
Srinivas Akkaraju joined Amarin as a non-executive director in May 2008. Dr.
Akkaraju is a founding Managing Director of Panorama Capital and focuses
primarily on life sciences investments. Previously, he was with J.P. Morgan
Partners, serving as a Principal, starting in April 2001 and becoming a Partner
in January 2005. From 1998 to 2001, Dr. Akkaraju was in Business and Corporate
Development at Genentech, Inc., most recently as Senior Manager responsible for
worldwide partnering activities, in-licensing of therapeutics, and out-licensing
of development projects. In addition to his business development role, Dr.
Akkaraju also served as a Project Team Leader for one of Genentech’s clinical
development products. During this time, he also was a founding member of
BioStreet, an online marketplace for biotech opportunities. Dr. Akkaraju holds
B.A. degrees in both Biochemistry and Computer Science from Rice University and
an M.D. and Ph.D. in Immunology from Stanford University School of Medicine. Dr.
Akkaraju currently serves on the board of directors of Presidio Pharmaceuticals,
Itero Biopharmaceuticals, Barrier Therapeutics, Inc., Phenomix Corporation,
Piramed Limited, Seattle Genetics, Inc., and Pharmos, Inc.
Dr. Lars
Ekman joined Amarin as a non-executive director in November 2008. He has more
than 24 years experience in the pharmaceutical industry. He was formerly
Executive Vice President and President of Global Research and Development at
Elan Corporation plc, where he is currently a director and chairs the Science
and Technology Committee. Prior to joining Elan, he was Executive Vice
President, Research and Development at Schwarz Pharma AG and was employed in a
variety of senior scientific and clinical functions at Pharmacia, now Pfizer.
Dr. Ekman also sits on the Board of Directors of ARYx Therapeutics Inc.,
InterMune Inc., and Cebix. Dr. Ekman is a board certified surgeon with a Ph.D in
experimental biology and has held several clinical and academic positions in
both the United States and Europe. He obtained his Ph.D and M.D. from the
University of Gothenburg, Sweden.
Mr. Alan
Cooke joined Amarin in May 2004 as Chief Financial Officer and was subsequently
promoted to President and Chief Operating Officer. Prior to joining Amarin, he
held a number of positions over a period of approximately eight years at Elan
Corporation, plc, including Vice President, Global Strategic Planning. Mr. Cooke
is a fellow of the Institute of Chartered Accountants (Ireland) and worked four
years with KPMG, Dublin.
Dr.
Declan Doogan joined us on April 10, 2007 as Head, Research and Development.
Prior to joining us, Dr. Doogan was Senior Vice President and Head of Worldwide
Development at Pfizer Global Research & Development. In recent years, he
held a number of senior positions in Pfizer in the US and the UK. Dr. Doogan
joined Pfizer in 1982, where he led the Zoloft clinical development program. He
held positions in the UK and in Japan, where he was initially Medical Director
and later head of the company’s development organization. Dr. Doogan holds
Visiting Professorships at Harvard, Glasgow and Kitasato University in Japan. In
addition, Dr. Doogan holds a number of non-executive directorships in the US and
the U.K. Dr. Doogan received his medical degree from Glasgow University in 1975.
He is a Fellow of the Royal College of Physicians of Glasgow and the Faculty of
Pharmaceutical Medicine in the U.K.
Mr. Tom
Maher was appointed General Counsel and Company Secretary in February 2006,
having commenced working with the Group on a part-time basis in July 2005. Mr.
Maher was previously a partner at Matheson Ormsby Prentice Solicitors, Dublin.
Prior to Matheson Ormsby Prentice, Mr. Maher worked at Elan Corporation plc
where he held the position of Vice President of Legal Affairs. Mr. Maher
commenced his legal career at A&L Goodbody Solicitors, Dublin. He holds a
law degree from Trinity College Dublin and is an Irish qualified
solicitor.
Mr. Conor
Dalton was appointed Vice-President, Finance in May 2005. Prior to joining
Amarin, Mr. Dalton spent approximately eight years with Elan Corporation, most
recently as Director of Finance. Mr. Dalton is a fellow of the Association of
Chartered Certified Accountants.
There is
no family relationship between any director or executive officer and any other
director or executive officer.
B. Compensation
General
Directors
who are not officers or employees receive £25,000 ($46,000) per annum save for
the Chairman of the Board who receives £40,000 ($74,000), Chairman of the Audit
Committee who receives £40,000 ($74,000), Chairman of the Remuneration Committee
who receives £40,000 ($74,000) and Lead Independent Director who receives
£20,000 ($37,000) and such options to acquire Ordinary Shares for their service
as non-executive members of the board of directors as the Remuneration Committee
of the board of directors may from time to time determine. Mr. Groom waived
emoluments in respect of the years ended December 31, 2008, 2007 and
2006.
For the
year ended December 31, 2008, all of our directors and senior management as a
group received total compensation of $3,295,000 and in addition, directors and
senior management were issued options to purchase a total of 1,130,000 Ordinary
Shares during such period. See “— Share Ownership” below for the specific terms
of the options held by each director and officer.
With the
exception of Mr. Lynch, Mr. Cooke and Dr. Doogan, there are no sums set aside or
accrued by us for pension, retirement or similar benefits for directors. We do
make contributions to certain of our employees’ and officers’ pensions during
the term of their employment with us.
Compensation
payable and benefits granted to our directors during the year ended December 31,
2008 are detailed below:
Directors’
detailed emoluments
Name
|
|
Salary
& fees $000
|
|
|
Benefits
in kind $000
|
|
|
Annual
bonus $000
|
|
|
2008
Total $000
|
|
Thomas
Lynch (Chairman and Chief Executive Officer)*
|
|
|
516 |
|
|
|
— |
|
|
|
100 |
|
|
|
616 |
|
Dr.
William Mason~
|
|
|
117 |
|
|
|
— |
|
|
|
— |
|
|
|
117 |
|
Anthony
Russell-Roberts~
|
|
|
93 |
|
|
|
— |
|
|
|
— |
|
|
|
93 |
|
Dr.
John Climax~
|
|
|
46 |
|
|
|
— |
|
|
|
— |
|
|
|
46 |
|
Dr.
James I. Healy**
|
|
|
29 |
|
|
|
— |
|
|
|
— |
|
|
|
29 |
|
Dr.
Carl L. Gordon**
|
|
|
29 |
|
|
|
— |
|
|
|
— |
|
|
|
29 |
|
Dr.
Eric Aguiar**~
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Dr.
Srinivas Akkaraju**~
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Dr.
Lars Ekman***
|
|
|
8 |
|
|
|
— |
|
|
|
— |
|
|
|
8 |
|
Alan
Cooke (Chief Financial Officer) †
|
|
|
207 |
|
|
|
2 |
|
|
|
50 |
|
|
|
259 |
|
Dr.
Declan Doogan (Head, Research & Development) †
|
|
|
137 |
|
|
|
1 |
|
|
|
34 |
|
|
|
172 |
|
John
Groom†
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Dr.
Simon Kukes†
|
|
|
17 |
|
|
|
— |
|
|
|
— |
|
|
|
17 |
|
Dr.
Michael Walsh†
|
|
|
17 |
|
|
|
— |
|
|
|
— |
|
|
|
17 |
|
Dr.
Prem Lachman†
|
|
|
17 |
|
|
|
— |
|
|
|
— |
|
|
|
17 |
|
Prof.
William Hall†
|
|
|
17 |
|
|
|
— |
|
|
|
— |
|
|
|
17 |
|
|
|
|
1,250 |
|
|
|
3 |
|
|
|
225 |
|
|
|
1,437 |
|
_______________
Benefits
in kind include medical and life insurance for each executive director. No
benefits in kind were paid in respect of the directors. No expense allowances
were provided to the directors during the year.
*
|
Fees
in respect of a Consultancy Agreement with Mr. Thomas Lynch. See “Item 7B
— Related Party Transactions". In addition, Mr. Lynch had pension
contributions paid into his personal pension scheme or accrued by the
Group of $27,000.
|
**
|
Appointed
as directors May 16, 2008.
|
***
|
Appointed
as director November 3, 2008.
|
|
†
|
Resigned
as directors May 16, 2008. In addition to the above Mr. Cooke and Dr.
Doogan had pension contributions paid into their personal scheme or
accrued by the Group up to May 16, 2008 of $12,000 and $8,000
respectively.
|
~
|
On
June 1, 2009 and May 15, 2009, Drs Aguiar and Akkaraju resigned from their
positions as non-executive directors respectively. On October 16, 2009,
Mr. Anthony Russell-Roberts and Drs. John Climax and William Mason
resigned from their positions as non-executive
directors.
|
The
Amarin Corporation plc 2002 Stock Option Plan
The
Amarin Corporation plc 2002 Stock Option Plan came into effect on January 1,
2002. The term of the plan is ten years, and no award shall be granted under the
plan after January 1, 2012.
The plan
is administered by the remuneration committee of our board of
directors. A maximum of 800,000 Ordinary Shares may be issued under
the plan. This limit was increased to 898,643 Ordinary Shares by the
Remuneration Committee of the Group on December 6, 2006, pursuant to section
4(c) of the Plan to prevent dilution of the potential benefits available under
the Plan as a result of certain discounted share issues. This limit
was further increased to 1,200,000 Ordinary Shares at an Extraordinary General
Meeting held on January 25, 2007. This limit was further increased to
1,800,000 Ordinary Shares at an Annual General Meeting held on July 19,
2007. This limit was further increased to 4,000,000 Ordinary Shares
at an Annual General Meeting held on July 31, 2008. Directors, employees,
officers, consultants and independent contractors are eligible persons under the
plan. The remuneration committee may grant options to eligible persons. In
determining which eligible persons may receive an award of options and become
participants in the plan, as well as the terms of any option award, the
remuneration committee may take into account the nature of the services rendered
to us by the eligible persons, their present and potential contributions to our
success or such other factors as the remuneration committee, at its discretion,
shall deem relevant.
Two forms
of options may be granted under the plan: incentive stock options and
non-qualified stock options. Incentive stock options are options intended to
meet the requirements of Section 422 of the U.S. Internal Revenue Code of 1986,
as amended. Non-qualified stock options are options which are not intended to be
incentive stock options.
As a
condition to the grant of an option award, we and the recipient shall execute an
award agreement containing such restrictions, terms and conditions, if any, as
the remuneration committee may require. Option awards are to be granted under
the plan for no cash consideration or for such minimal cash consideration as may
be required by law. The exercise price of options granted under the plan shall
be determined by the remuneration committee; however the plan provides that the
exercise price shall not be less than 100% of the fair market value, as defined
under the plan, of an Ordinary Share on the date that the option is granted. The
consideration to be paid for the shares under option shall be paid at the time
that the shares are issued. The term of each option shall end ten years
following the date on which it was granted. The remuneration committee may
decide from time to time whether options granted under the plan may be exercised
in whole or in part.
No option
granted under the plan may be exercised until it has vested. The remuneration
committee will specify the vesting schedule for each option when it is granted.
If no vesting schedule is specified with respect to a particular option, then
the vesting schedule set out in the plan will apply so that 33% of the total
number of Ordinary Shares granted under the option shall vest on the first
anniversary of the date that the option was granted, a further 33% shall vest on
the second anniversary and the remaining 34% shall vest on the third
anniversary.
On
January 30, 2009 the plan was amended so that 25% of the total number of
Ordinary Shares granted under an option shall vest on the first anniversary of
the date that the option was granted, a further 25% shall vest on the second,
third and fourth anniversaries. This amendment applies to all option grants
after February 1, 2009.
If a
participant’s continuous status as an employee or consultant, as defined under
the plan, is terminated for cause then his or her options shall expire
immediately. If such status is terminated due to death or permanent disability
and if options held by the participant have vested and are exercisable, they
shall remain exercisable for twelve months following the date of the
participant’s death or disability.
No option
award, nor any right under an option award, may be transferred by a participant
other than by will or by the laws of descent as specifically set out in the
plan. Participants do not have any rights as a shareholder of record in us with
respect to the Ordinary Shares issuable on the exercise of their options until a
certificate representing such Ordinary Shares registered in the participant’s
name has been delivered to the participant.
The plan
is governed by the laws of England.
C. Board
Practices
General
No
director has a service contract providing for benefits upon the termination of
service or employment.
Our
articles of association stipulate that the minimum number of directors shall be
two and the maximum number shall be fifteen. At December 31, 2008 we had nine
directors. Directors may be elected by the shareholders at a general meeting or
appointed by the board of directors. If a director is appointed by the board of
directors, that director must stand for election at our subsequent annual
general meeting. At each annual general meeting, one-third of our directors must
retire and either stand, or not stand, for re-election. In determining which
directors shall retire and stand, or not stand, for re-election, first, we
include any director who chooses to retire and not face re-election and second,
we choose the directors who have served as directors for the longest period of
time since their last election.
On May
16, 2008, Drs. Doogan, Kukes, Walsh and Lachman, Prof. Hall and Messrs. Cooke
and Groom resigned from the board of directors. On the same date Drs. James I.
Healy, Carl Gordon, Eric Aguiar and Srinivas Akkaraju were appointed to the
board. On November 3, 2008 Dr. Lars Ekman was appointed to the board. On June 1
and May 15, 2009, Drs Aguiar and Akkaraju resigned from the board of directors
respectively. On October 16, 2009, Mr. Anthony Russell-Roberts and Drs.
John Climax and William Mason resigned from the board of directors.
At the
annual general meeting for 2008, Drs. James I. Healy and Carl Gordon stood for
election and Drs. Climax and Mason retired by rotation. Each director was
re-elected. Assuming no further directors choose to retire or resign and not
stand for re-election at the annual general meeting in 2009, we would expect Mr.
Lynch and Drs. Healy, Anderson, Rogan and Ekman to retire and stand
for re-election at the 2009 annual general meeting. See — “Directors and Senior
Management” above for details of when each of our directors joined our board of
directors.
Audit
Committee
The audit
committee of the board of directors generally comprises at least three of
our non-executive directors and meets, as required, to review the scope of the
audit and audit procedures, the format and content of the audited financial
statements and the accounting principles applied in preparing the financial
statements. The audit committee also reviews proposed changes in accounting
policies, recommendations from the auditors regarding improving internal
controls and the adequacy of resources within the accounting
function.
As of
December 31, 2008, the audit committee comprised the following
directors:
|
·
|
Dr.
William Mason (Chairman) (appointed October 22, 2002; resigned October 16,
2009);
|
|
·
|
Mr. Anthony Russell-Roberts (appointed May 16; resigned
October 16, 2009); |
|
·
|
Dr.
Srinivas Akkaraju (appointed May 16, 2008; resigned May 15, 2009);
and
|
|
·
|
Dr.
Eric Aguiar (appointed May 16, 2008; resigned June 1,
2009).
|
Remuneration
Committee
The
remuneration committee of the board of directors comprises at least three of our
non-executive directors. The remuneration committee’s primary responsibility is
to approve the level of remuneration for executive directors and key employees.
It may also grant options under our share option schemes to employees and
executive directors and must approve any service contracts for executive
directors and key employees. Non-executive directors’ remuneration is determined
by the full board of directors.
As of
December 31, 2008, the remuneration committee comprised the following
directors:
|
·
|
Mr.
Anthony Russell-Roberts (Chairman) (appointed July 19, 2002; resigned
October 16, 2009);
|
|
·
|
Dr.
William Mason (appointed May 16, 2008; resigned October 16,
2009);
|
|
·
|
Dr.
James I. Healy (appointed May 16, 2008);
and
|
|
·
|
Dr.
Carl Gordon (appointed May 16,
2008).
|
Lead
Independent Director
In
February 2008, our Board of Directors established the position of Lead
Independent Director and appointed current board member, Dr. William Mason, to
that role. In his capacity as Lead Independent Director, Dr. Mason had the
authority to convene meetings of the independent directors, and to preside
over those meetings, to coordinate the activities of the independent
directors, and to act as a liaison between the independent directors, the
Board and the Chairman. On October 16, 2009, Dr. William Mason resigned
his position of Lead Independent Director. See Item 8B "Significant
Changes" for further information.
D. Employees
The
average numbers of employees employed by us during each of the past three
financial years are detailed below:
|
|
Number
of
Employees
|
|
|
Number
of
Employees
|
|
|
Number
of
Employees
|
|
Employment Activity
|
|
12/31/08
|
|
|
12/31/07
|
|
|
12/31/06
|
|
Marketing
and Administration
|
|
|
17 |
|
|
|
17 |
|
|
|
12 |
|
Research
and Development
|
|
|
10 |
|
|
|
8 |
|
|
|
6 |
|
Total
|
|
|
27 |
|
|
|
25 |
|
|
|
18 |
|
The
average numbers of employees employed by us by geographical region for each of
the last three financial years are set forth below:
|
|
Number
of
Employees
|
|
|
Number
of
Employees
|
|
|
Number
of
Employees
|
|
Country
|
|
12/31/08
|
|
|
12/31/07
|
|
|
12/31/06
|
|
U.K.
|
|
|
11 |
|
|
|
11 |
|
|
|
10 |
|
Ireland
|
|
|
12 |
|
|
|
14 |
|
|
|
8 |
|
U.S.
|
|
|
4 |
|
|
|
— |
|
|
|
— |
|
Total
|
|
|
27 |
|
|
|
25 |
|
|
|
18 |
|
E. Share
Ownership
The
beneficial ownership of Ordinary Shares by, and options granted to, our
directors or officers, including their spouses and children under eighteen years
of age, as of December 31, 2008 are presented in the table below. See also “—
Compensation — the Amarin Corporation plc 2002 Stock Option and the Amarin Long
Term Incentive Plan”.
|
|
|
|
|
Options/Warrants
Outstanding to Acquire Number of Ordinary Shares
|
|
|
|
|
|
Exercise
Price per Ordinary Share
|
|
|
Ordinary
Shares or ADS Equivalents Beneficially Owned
|
|
|
Percentage
of Outstanding Share Capital*
|
|
T.G.
Lynch
|
|
|
2 |
|
|
|
50,000 |
|
|
25/02/04
|
|
|
|
$19.00 |
|
|
|
1,072,906 |
|
|
|
4.0 |
% |
|
|
|
7 |
|
|
|
20,792 |
|
|
21/12/05
|
|
|
|
$14.30 |
|
|
|
|
|
|
|
|
|
|
|
|
9 |
|
|
|
1,248 |
|
|
01/06/07
|
|
|
|
$7.20 |
|
|
|
|
|
|
|
|
|
|
|
|
10 |
|
|
|
30,303 |
|
|
06/12/07
|
|
|
|
$2.99 |
|
|
|
|
|
|
|
|
|
W.
Mason
|
|
|
1 |
|
|
|
1,500 |
|
|
06/11/02
|
|
|
|
$31.00 |
|
|
|
— |
|
|
|
— |
|
|
|
1&3
|
|
|
|
2,500 |
|
|
21/07/04
|
|
|
|
$8.40 |
|
|
|
|
|
|
|
|
|
|
|
1&3
|
|
|
|
2,000 |
|
|
11/01/06
|
|
|
|
$13.50 |
|
|
|
|
|
|
|
|
|
|
|
1&13
|
|
|
|
2,000 |
|
|
08/12/06
|
|
|
|
$4.40 |
|
|
|
|
|
|
|
|
|
A.
Russell-Roberts
|
|
|
4 |
|
|
|
1,000 |
|
|
07/04/00
|
|
|
|
$30.00 |
|
|
|
235 |
|
|
|
— |
|
|
|
|
4 |
|
|
|
1,000 |
|
|
19/02/01
|
|
|
|
$61.20 |
|
|
|
|
|
|
|
|
|
|
|
|
1 |
|
|
|
1,500 |
|
|
23/01/02
|
|
|
|
$176.50 |
|
|
|
|
|
|
|
|
|
|
|
|
1 |
|
|
|
1,500 |
|
|
06/11/02
|
|
|
|
$31.00 |
|
|
|
|
|
|
|
|
|
|
|
|
1 |
|
|
|
2,500 |
|
|
21/07/04
|
|
|
|
$8.40 |
|
|
|
|
|
|
|
|
|
|
|
|
1 |
|
|
|
2,000 |
|
|
11/01/06
|
|
|
|
$13.50 |
|
|
|
|
|
|
|
|
|
|
|
1&13
|
|
|
|
2,000 |
|
|
08/12/06
|
|
|
|
$4.40 |
|
|
|
|
|
|
|
|
|
J.
Climax
|
|
|
7 |
|
|
|
22,698 |
|
|
21/12/05
|
|
|
|
$14.30 |
|
|
|
1,465,755 |
|
|
|
5.4 |
% |
|
|
|
1 |
|
|
|
2,000 |
|
|
27/01/06
|
|
|
|
$27.20 |
|
|
|
|
|
|
|
|
|
|
|
|
1 |
|
|
|
2,000 |
|
|
20/03/06
|
|
|
|
$32.60 |
|
|
|
|
|
|
|
|
|
|
|
1&13
|
|
|
|
2,000 |
|
|
08/12/06
|
|
|
|
$4.40 |
|
|
|
|
|
|
|
|
|
|
|
|
11 |
|
|
|
3,327 |
|
|
01/06/07
|
|
|
|
$7.20 |
|
|
|
|
|
|
|
|
|
|
|
|
12 |
|
|
|
136,363 |
|
|
06/12/07
|
|
|
|
$2.99 |
|
|
|
|
|
|
|
|
|
J.
Healy
|
|
|
14 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
3,586,957 |
|
|
|
13.3 |
% |
C.
Gordon
|
|
|
15 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
3,260,870 |
|
|
|
12.1 |
% |
E.
Aguiar
|
|
|
16 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2,173,913 |
|
|
|
8.0 |
% |
S.
Akkaraju
|
|
|
17 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,847,826 |
|
|
|
6.9 |
% |
A.
Cooke
|
|
|
1 |
|
|
|
37,500 |
|
|
07/07/04
|
|
|
|
$8.50 |
|
|
|
27,021 |
|
|
|
— |
|
|
|
|
5 |
|
|
|
20,000 |
|
|
10/06/05
|
|
|
|
$13.00 |
|
|
|
|
|
|
|
|
|
|
|
|
6 |
|
|
|
1,559 |
|
|
21/12/05
|
|
|
|
$14.30 |
|
|
|
|
|
|
|
|
|
|
|
|
1 |
|
|
|
20,000 |
|
|
16/01/06
|
|
|
|
$19.50 |
|
|
|
|
|
|
|
|
|
|
|
1&13
|
|
|
|
67,500 |
|
|
08/12/06
|
|
|
|
$4.40 |
|
|
|
|
|
|
|
|
|
|
|
|
1 |
|
|
|
400,000 |
|
|
20/05/08
|
|
|
|
$2.60 |
|
|
|
— |
|
|
|
— |
|
D.
Doogan
|
|
1&13
|
|
|
|
65,000 |
|
|
09/04/07
|
|
|
|
$4.40 |
|
|
|
— |
|
|
|
— |
|
|
|
|
1 |
|
|
|
400,000 |
|
|
20/05/08
|
|
|
|
$2.60 |
|
|
|
— |
|
|
|
— |
|
T.
Maher
|
|
|
1 |
|
|
|
32,500 |
|
|
02/12/05
|
|
|
|
$11.60 |
|
|
|
1,980 |
|
|
|
|
|
|
|
|
6 |
|
|
|
693 |
|
|
21/12/05
|
|
|
|
$14.30 |
|
|
|
|
|
|
|
|
|
|
|
1&13
|
|
|
|
35,000 |
|
|
08/12/06
|
|
|
|
$4.40 |
|
|
|
|
|
|
|
|
|
|
|
|
1 |
|
|
|
15,000 |
|
|
02/08/07
|
|
|
|
$4.40 |
|
|
|
|
|
|
|
|
|
|
|
|
1 |
|
|
|
15,000 |
|
|
28/08/07
|
|
|
|
$4.60 |
|
|
|
|
|
|
|
|
|
|
|
|
1 |
|
|
|
280,000 |
|
|
20/05/08
|
|
|
|
$2.60 |
|
|
|
— |
|
|
|
— |
|
C.
Dalton
|
|
|
1 |
|
|
|
10,000 |
|
|
28/06/05
|
|
|
|
$10.90 |
|
|
|
— |
|
|
|
— |
|
|
|
|
1 |
|
|
|
5,000 |
|
|
12/01/06
|
|
|
|
$15.30 |
|
|
|
— |
|
|
|
— |
|
|
|
1&13
|
|
|
|
20,000 |
|
|
08/12/06
|
|
|
|
$4.40 |
|
|
|
— |
|
|
|
— |
|
|
|
|
1 |
|
|
|
50,000 |
|
|
20/05/08
|
|
|
|
$2.60 |
|
|
|
— |
|
|
|
— |
|
Notes:
|
(1)
|
These
options are exercisable as to one third on each of the first, second and
third anniversaries of the date of grant and remain exercisable for a
period ended on the tenth anniversary of the date of
grant.
|
|
(2)
|
The
Ordinary Shares are held in the form of ADSs by Amarin Investment Holding
Limited. The warrants issued to Amarin Investment Holding Limited are
exercisable for up to 50,000 Ordinary Shares, on or before February 25,
2009. Amarin Investment Holding Limited is an entity controlled by our
Chairman and Chief Executive Officer, Mr. Thomas
Lynch.
|
|
(3)
|
These
options were issued to Vision Resources Limited, a company wholly owned by
Dr. Mason.
|
|
(4)
|
These
options are currently exercisable and remain exercisable until ten years
from the date of grant.
|
|
(5)
|
These
options are exercisable as to 50% on the second anniversary of grant, as
to 75% of the third anniversary of grant and in full on the fourth
anniversary of grant.
|
|
(6)
|
These
warrants were granted to all investors in the December 2005 private
placement including directors and are exercisable at anytime after 180
days from the grant date. If our trading market price is equal to or above
$102, as adjusted for any stock splits, stock combinations, stock
dividends and other similar events, for each of any twenty consecutive
trading days, then the Group at any time thereafter shall have the right,
but not the obligation, on 20 days’ prior written notice to the holder, to
cancel any unexercised portion of this warrant for which a notice of
exercise has not yet been delivered prior to the cancellation
date.
|
|
(7)
|
These
warrants were granted to all investors in the December 2005 private
placement including directors and are exercisable at anytime after 180
days from the grant date. The warrants were issued to Amarin Investment
Holding Limited which is an entity controlled by our Chairman and Chief
Executive Officer, Mr. Thomas Lynch. If our trading market price is equal
to or above $102, as adjusted for any stock splits, stock combinations,
stock dividends and other similar events, for each of any twenty
consecutive trading days, then the Group at any time thereafter shall have
the right, but not the obligation, on 20 days’ prior written notice to the
holder, to cancel any unexercised portion of this warrant for which a
notice of exercise has not yet been delivered prior to the cancellation
date.
|
|
(8)
|
The
Ordinary Shares are held in the form of ADSs by Sunninghill Limited. The
warrants granted to all investors in the December 2005 private placement
including directors are exercisable at any time after 180 days from the
grant date. These warrants were issued to Sunninghill Limited which is an
entity controlled by one of our non-executive directors Dr. John
Climax.
|
|
(9)
|
These
warrants were granted to all investors in the June 2007 registered direct
offering including directors and are exercisable immediately from the
grant date. The warrants were issued to Amarin Investment Holding Limited
which is an entity controlled by our Chairman and Chief Executive Officer,
Mr. Thomas Lynch.
|
|
(10)
|
These
warrants were granted to all investors in the December 2007 registered
direct offering including directors and are exercisable immediately from
the grant date. The warrants were issued to Amarin Investment Holding
Limited which is an entity controlled by our Chairman and Chief Executive
Officer, Mr. Thomas Lynch. There is a price adjustment clause in the
December 2007 warrant agreement which provides that if, at any time prior
to December 6, 2009, the Company issues Ordinary Shares, securities
convertible into ADSs or Ordinary Shares, warrants to purchase ADSs or
Ordinary Shares, or options to purchase any of the foregoing to a third
party (other than any Exempt Issuance) at a price that is less than, or
converts at a price that is less than $3.66 (such lesser price, the
“Down-round Price”), then the Exercise Price shall be adjusted to equal
130% of
|
|
the
Down round Price. On May 16, 2008, Amarin raised gross proceeds of
$30,000,000 in a private placement of equity at a share price of $2.30 per
Ordinary Share. As $2.30 is below the Down-round Price, the initial
warrant exercise price has been adjusted from $4.80 to $2.99. On October
16, 2009, $3.6 million convertible bridge notes converted at $0.90 per
share (see note 35 for further details). These warrants have therefore
been re-priced again, to $1.17 per
share.
|
|
(11)
|
These
warrants were granted to all investors in the June 2007 registered direct
offering including directors and are exercisable immediately from the
grant date. These warrants were issued to Sunninghill Limited which is an
entity controlled by one of our non-executive directors Dr. John
Climax.
|
|
(12)
|
These
warrants were granted to all investors in the December 2007 registered
direct offering including directors and are exercisable immediately from
the grant date. These warrants were issued to Sunninghill Limited which is
an entity controlled by one of our non-executive directors Dr. John
Climax. There is a price adjustment clause in the December 2007 warrant
agreement which provides that if, at any time prior to December 6, 2009,
the Company issues Ordinary Shares, securities convertible into ADSs or
Ordinary Shares, warrants to purchase ADSs or Ordinary Shares, or options
to purchase any of the foregoing to a third party (other than any Exempt
Issuance) at a price that is less than, or converts at a price that is
less than $3.66 (such lesser price, the “Down-round Price”), then the
Exercise Price shall be adjusted to equal 130% of the Down round Price. On
May 16, 2008, Amarin raised gross proceeds of $30,000,000 in the first
tranche of a private placement of equity at a share price of $2.30 per
Ordinary Share. As $2.30 is below the Down-round Price, the initial
warrant exercise price has been adjusted from $4.80 to $2.99. On October
16, 2009, $3.6 million convertible bridge notes converted at $0.90 per
share (see note 35 for further details). These warrants have therefore
been re-priced again, to $1.17 per
share.
|
|
(13)
|
The
exercise price of all options granted between December 8, 2006 and April
11, 2007 were amended to $4.40 – see note 28 to the F-section in this
annual report for further details of the options
amendment.
|
|
(14)
|
These
shares have been issued to Sofinnova Venture Partners VII, L.P., the
management company of which Dr. James I. Healy is a Managing General
Partner. Dr. James I. Healy is also a non-executive director of
Amarin.
|
|
(15)
|
These
shares have been issued to Caduceus Private Investments III, LP and
OrbiMed Associates III, LP, of whom Dr. Carl L. Gordon is a General
Partner. Dr. Carl L. Gordon is also a non-executive director of
Amarin.
|
|
(16)
|
These
shares have been issued to Thomas, McNerney & Partners II, L.P., TMP
Nominee II, LLC and TMP Associates II, L.P., of whom Dr. Eric Aguiar is a
Partner. Dr. Eric Aguiar resigned as a non-executive director
of Amarin on June 1, 2009.
|
|
(17)
|
These
shares have been issued to Panorama Capital, L.P., of whom Dr. Srinivas
Akkaraju was a former Managing Director. Dr. Srinivas Akkaraju
resigned as a non-executive director of Amarin on May 15,
2009.
|
* This
information is based on 27,046,716 Ordinary Shares outstanding as of December
31, 2008.
Item
7 Major
Shareholders and Related Party Transactions
A. Major
Shareholders
The
following table sets forth to the best of our knowledge certain information
regarding the ownership of our Ordinary Shares at December 31, 2008 by each
person who is known to us to be the beneficial owner of more than five percent
of our outstanding Ordinary Shares, either directly or by virtue of ownership of
ADSs.
Name of Owner(1)
|
|
Number
of
Ordinary
Shares
or
ADS Equivalents
Beneficially
Owned
|
|
|
Percentage
of
Share
Capital(2)
|
|
Sofinnova
Ventures (3)
|
|
|
3,586,957 |
|
|
|
11.24 |
% |
Orbimed
Advisors LLC
(4)
|
|
|
3,260,870 |
|
|
|
10.24 |
% |
Thomas,
McNerney & Partners LLC (5)
|
|
|
2,173,913 |
|
|
|
6.82 |
% |
Panorama
Capital LP
(6)
|
|
|
1,847,826 |
|
|
|
5.80 |
% |
Sunninghill
Limited
(7)
|
|
|
1,634,143 |
|
|
|
5.13 |
% |
Notes:
|
|
|
|
|
|
|
|
|
(1)
|
Unless
otherwise noted, the persons referred to above have sole investment
power.
|
(2)
|
This
information is based on 27,046,716 Ordinary Shares outstanding, 2,052,473
warrants granted over Ordinary Shares and 2,742,852 share options granted
over Ordinary Shares as of December 31,
2008.
|
(3)
|
These
shares have been issued to Sofinnova Venture Partners VII, L.P., the
management company of which Dr. James I. Healy is a Managing General
Partner. Dr. James I. Healy is also a non-executive director of
Amarin.
|
(4)
|
These
shares have been issued to Caduceus Private Investments III, LP and
OrbiMed Associates III, LP, of which Dr. Carl L. Gordon is a General
Partner. Dr. Carl L. Gordon is also a non-executive director of
Amarin.
|
Name of Fund
|
|
|
|
Caduceus
Private Investments III,
LP
|
|
|
3,230,107 |
|
OrbiMed
Associates III,
LP
|
|
|
30,763 |
|
(5)
|
These
shares have been issued to Thomas, McNerney & Partners II, L.P., TMP
Nominee II, LLC and TMP Associates II, L.P., of whom Dr. Eric Aguiar is a
Partner. Dr. Eric Aguiar resigned as a non-executive director
of Amarin on June 1, 2009.
|
Name of Fund
|
|
|
|
Thomas,
McNerney & Partners II,
L.P
|
|
|
2,143,913 |
|
TMP
Nominee II,
LLC
|
|
|
22,391 |
|
TMP
Associates II,
L.P.
|
|
|
7,609 |
|
(6)
|
These
shares have been issued to Panorama Capital, L.P., of which Dr. Srinivas
Akkaraju was a former Managing Director. Dr. Srinivas Akkaraju
resigned as a non-executive director of Amarin on May 15,
2009.
|
(7)
|
Includes
warrants to purchase 162,389 Ordinary Shares, which are currently
exercisable and share options to purchase 6,000 Ordinary Shares of which
4,000 are currently exercisable. Sunninghill Limited is an entity
controlled by one of our non-executive directors, Dr. John
Climax.
|
|
The
following table shows changes over the last three years in the percentage
of the issued share capital for the Group held by major shareholders,
either directly or by virtue of ownership of
ADSs:
|
Name of Owner(1)
|
|
|
|
|
|
|
|
|
|
|
|
%
|
|
|
%
|
|
|
%
|
|
Sofinnova
Ventures (1)
|
|
|
13.3 |
|
|
|
— |
|
|
|
— |
|
Orbimed
Advisors LLC
(1)
|
|
|
12.1 |
|
|
|
— |
|
|
|
— |
|
Thomas,
McNerney & Partners LLC (1)
|
|
|
8.0 |
|
|
|
— |
|
|
|
— |
|
Panorama
Capital LP
(1)
|
|
|
6.8 |
|
|
|
— |
|
|
|
— |
|
Amarin
Investment Holding Limited
|
|
|
4.0 |
|
|
|
7.7 |
|
|
|
11.0 |
|
Simon
G. Kukes
|
|
|
4.7 |
|
|
|
6.8 |
|
|
|
8.3 |
|
Medica
Funds
|
|
|
3.7 |
|
|
|
7.2 |
|
|
|
— |
|
Sunninghill
Limited
|
|
|
5.4 |
|
|