e20vf
UNITED STATES SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C.
20549
Form 20-F
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REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR
12(g) OF THE SECURITIES EXCHANGE ACT OF 1934
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OR
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þ
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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FOR THE FISCAL YEAR ENDED
DECEMBER 31, 2005
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OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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FOR THE TRANSITION PERIOD
FROM TO
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OR
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SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
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DATE OF EVENT REQUIRING THIS
SHELL COMPANY REPORT
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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)
7 Curzon Street
London W1J 5HG
England
(Address of Principal
Executive Offices)
SECURITIES REGISTERED OR TO BE REGISTERED PURSUANT TO
SECTION 12(b) OF THE ACT:
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Title of Each Class
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Name of Each Exchange on Which
Registered
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None
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None
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SECURITIES REGISTERED OR TO BE REGISTERED PURSUANT TO
SECTION 12(g) OF THE ACT:
American Depositary Shares, each representing one Ordinary
Share
Ordinary Shares, 5 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
issuers classes of capital or common stock as of the close
of the period covered by the annual report.
77,548,908 Ordinary Shares, 5 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 þ
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 þ
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 þ 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 þ
Indicate by check mark which financial statement item the
registrant has elected to follow.
ITEM 17 o ITEM 18 þ
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 þ
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, 2005.
As used in this annual report, unless the context otherwise
indicates, the terms Company, Amarin,
we, us and our refer to
Amarin Corporation plc and its wholly owned subsidiary
companies. Additionally, Amarin Pharmaceuticals, Inc., our
former US subsidiary may be referred to in this annual report as
API, and Amarin Development (Sweden) AB, our former
Swedish subsidiary may be referred to in this annual report as
Amarin Development AB or ADAB. Elan
Corporation plc or its affiliates, a former related party, may
be referred to in this annual report as Elan.
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.
Also, as used in this annual report, unless the context
otherwise indicates, the term Ordinary Shares refers
to our Ordinary Shares, par value per share, and the term
Preference Shares refers to our authorised
preference shares, par value 5 pence per share. There are
currently no Preference Shares outstanding. 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
ten-for-one
Ordinary Share consolidation effective on July 17, 2002
whereby ten ordinary shares of 10p each became one Ordinary
Share of £1.00 each and 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.
In this annual report, references to pounds
sterling, £ or GBP£ are
to UK currency and references to US dollars,
$ or US$ are to US currency.
This annual report contains trademarks, tradenames or registered
marks owned by Amarin or by other entities, including:
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Miraxiontm
which is registered in the name of our subsidiary Amarin
Neuroscience Limited;
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Phrenilin®,
Bontriltm
and
Motofen®,
which were registered in or used by us or our former affiliates;
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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;
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Zelapartm,
which is registered in Valeant Pharmaceuticals International
which we may refer to in this annual report as
Valeant; and
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Moraxentm,
which is registered in CeNeS Limited or its affiliates which we
may refer to in this annual report as CeNeS.
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3
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;
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The success of our research and development activities,
including the phase III trials with Miraxion in
Huntingtons disease;
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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;
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The speed with which regulatory authorizations, pricing
approvals and product launches may be achieved;
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The success with which developed products may be commercialized;
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Competitive developments affecting our products under
development;
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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;
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Claims and concerns that may arise regarding the safety or
efficacy of our product candidates;
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Governmental laws and regulations affecting our operations,
including those affecting taxation;
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Our ability to maintain sufficient cash and other liquid
resources to meet operating requirements; general changes in
U.K. and U.S. generally accepted accounting principles;
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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;
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Uncertainties of the FDA approval process and the regulatory
approval processes in other countries, including, without
limitation, delays in approval of new products;
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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; and
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Growth in costs and expenses; and the impact of acquisitions,
divestitures and other unusual items, including our ability to
integrate our acquisition of Amarin Neuroscience Limited.
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4
PART I
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Item 1
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Identity
of Directors, Senior Management and Advisers
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Not applicable.
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Item 2
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Offer
Statistics and Expected Timetable
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Not applicable.
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A.
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Selected
Financial Data
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General
The following table presents selected historical consolidated
financial data. The selected historical consolidated financial
data as of December 31, 2003, 2004 and 2005 and for each of
the three years ended December 31, 2003, 2004 and 2005 have
been derived from our audited consolidated financial statements
beginning on
page F-1
of this annual report, which have been audited by
PricewaterhouseCoopers LLP, an independent registered public
accountant firm, for the years ended December 31, 2003,
2004 and 2005. The selected historical consolidated financial
data as of December 31, 2002 and 2001 and for the years
then ended has been derived from our audited historical
financial statements 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
generally accepted accounting principles in the UK, which we
refer to as UK GAAP and which differ in certain
significant aspects from generally accepted accounting
principles in the US, which we refer to as US GAAP.
These differences have a material effect on net income/ (loss)
and the composition of shareholders equity. A detailed
analysis of these differences can be found in Note 42 to
the consolidated financial statements beginning on
page F-1
of this annual report. Note 42 to our consolidated
financial statements also provides a reconciliation of our
consolidated financial statements to US GAAP.
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 10p 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. 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.
5
Selected
Consolidated Financial Data
(In
US $, thousands, except for per share and number of shares
information)
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Years Ended
December 31
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2001
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2002
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2003
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2004
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2005
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(In US $, thousands except
per share data and number
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of shares information)
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Statement of Operations
Data UK GAAP
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Net sales revenues
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63,031
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65,441
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7,365
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1,017
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500
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Total (loss) from operations
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(4,876
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(32,630
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(38,821
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(11,092
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(18,908
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(Loss) from continuing operations
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(4,358
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(6,130
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(6,200
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(9,927
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(18,908
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Net (loss)/income
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(5,264
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(37,047
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(19,224
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4,012
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(18,707
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(Loss) from continuing operations
per Ordinary Share (basic)
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(0.60
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(0.66
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(0.36
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(0.44
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(0.41
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Net income/(loss) per Ordinary
Share (basic)
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(0.74
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(4.00
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(1.13
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0.21
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(0.40
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Net income/(loss) per Ordinary
Share (diluted)
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(0.74
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(4.00
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(1.13
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0.21
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(0.40
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Amounts in accordance with US
GAAP
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Net sales revenues
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63,031
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65,441
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7,365
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1,017
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Operating (loss)
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(3,230
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(28,571
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(25,841
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(67,182
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)
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(19,527
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Net (loss)
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(5,444
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)
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(31,014
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)
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(28,436
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(67,202
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(19,630
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Net (loss) per Ordinary Share
(basic)
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(0.76
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(3.34
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(1.66
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(2.99
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(0.42
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Net (loss) per Ordinary Share
(diluted)
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(0.76
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(3.34
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(1.66
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(2.99
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(0.42
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Weighted average shares (basic)
(thousands)
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7,125
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9,297
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17,093
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22,511
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46,590
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Weighted average shares (diluted)
(thousands)
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12,035
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11,896
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17,440
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22,511
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46,590
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Consolidated balance sheet
data
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Amounts in accordance with UK
GAAP
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Working capital
(liabilities)/assets
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(13,400
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(19,306
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(39,128
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)
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8,651
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28,673
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Total assets
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100,597
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97,438
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47,377
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23,721
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46,760
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Long term obligations
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(8,391
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(36,743
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(2,687
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(180
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Capital stock (ordinary shares)
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12,354
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15,838
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29,088
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3,206
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6,778
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Total shareholders
equity/(deficit)
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32,797
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(6,208
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(6,348
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)
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16,693
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38,580
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Number of ordinary shares in issue
(thousands)
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76,764
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9,838
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17,940
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37,632
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77,549
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Denomination of each ordinary share
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£0.10
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£1.00
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£1.00
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£0.05
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£0.05
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Number of £ 13% cumulative
preference shares in issue (thousands)
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4,130
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2,000
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Amounts in accordance with US
GAAP
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Working capital
(liabilities)/assets
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(12,082
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)
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(19,742
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(39,183
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)
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8,637
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28,386
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Total assets
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85,688
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91,755
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43,173
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13,423
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36,650
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Long term obligations/deferred
credit
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(6,559
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(39,388
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)
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(43,640
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)
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(41,519
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Capital stock (ordinary shares)
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11,139
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15,838
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29,088
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3,206
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6,778
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Total shareholders
equity/(deficit)
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25,090
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(8,724
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)
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(10,552
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)
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(34,593
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)
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(12,680
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)
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Number of ordinary shares in issue
(thousands)
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76,764
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9,838
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17,940
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37,632
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77,549
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Denomination of each ordinary share
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£0.10
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£1.00
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£1.00
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£0.05
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£0.05
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Number of £ 13% cumulative
preference shares in issue (thousands)
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4,130
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2,000
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6
Exchange
Rates
We changed our functional currency on January 1, 2003 to US
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 US dollars from 2003 and comparative information for prior
years has been restated into US dollars. Under UK GAAP this
restatement of all historical pound sterling amounts has been at
an exchange rate of £1 to $1.6099, being the mid point rate
on December 31, 2002. Under US GAAP the historical pound
sterling amounts have been restated using the weighted average
rate for the income statement and applicable closing rate for
the balance sheet, including in the table above.
As some assets, liabilities and transactions are still
denominated in pounds sterling the rate of exchange between
pounds sterling and the US 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 rate between the US dollar and the
pound sterling may affect any earnings or losses reported by us
and the book value of our shareholders equity as expressed
in US dollars and pounds sterling, 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 US dollars per
pound sterling:
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Average
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Noon Buying
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Fiscal Period
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Rate
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(US dollars/pound
sterling)
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12 months ended
December 31, 2001
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1.4543
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12 months ended
December 31, 2002
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1.5093
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12 months ended
December 31, 2003
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1.6450
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12 months ended
December 31, 2004
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1.8356
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12 months ended
December 31, 2005
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1.8204
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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 Bank of New York for pounds sterling
expressed in US dollars per pound sterling:
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|
|
|
|
|
|
Month
|
|
High Noon Buying Rate
|
|
|
Low Noon Buying Rate
|
|
|
|
(US dollars/pound
sterling)
|
|
|
(US dollars/pound
sterling)
|
|
|
September 2005
|
|
|
1.842
|
|
|
|
1.762
|
|
October 2005
|
|
|
1.7855
|
|
|
|
1.7484
|
|
November 2005
|
|
|
1.7755
|
|
|
|
1.7138
|
|
December 2005
|
|
|
1.774
|
|
|
|
1.7188
|
|
January 2006
|
|
|
1.7885
|
|
|
|
1.7404
|
|
February 2006
|
|
|
1.7807
|
|
|
|
1.7343
|
|
The noon buying rate as of March 29, 2006 was 1.7356 US
dollars per pound sterling.
|
|
B.
|
Capitalization
And Indebtedness
|
Not applicable.
|
|
C.
|
Reasons
For The Offer And Use Of Proceeds
|
Not applicable.
7
RISK
FACTORS
You should carefully consider the risks and the information
about our business described below, together with all of 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, and the trading price of our
ADSs 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, 2001, 2002,
2003, 2004, and 2005 we reported (losses)/profits of
approximately $(5.3) million, $(37.0) million, $(19.2)
million, $4.0 million and ($18.7) million respectively
under UK GAAP. Unless and until marketing approval is obtained
from either the U.S. Food and Drug Administration
(FDA) or European Medicines Evaluation Agency
(EMEA) for our principal product,
Miraxiontm,
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 revenues in future periods and we may not be
able to attain profitability.
By February 2004, we had divested a majority of our assets.
Although we subsequently acquired Amarin Neuroscience Limited
(formerly Laxdale Limited) and its leased facility in Stirling,
Scotland on October 8, 2004, we continue to have limited
operations, assets and financial resources. As a result, we
currently have no marketable products or other source of
revenues. All of our current products, including Miraxion, our
principal product, 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 able to obtain regulatory
approval and sell our future products in significant quantities.
This may result in net operating losses, which will increase
continuously 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
also intend to 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 Miraxion or any other 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.
Our
historical financial results do not form an accurate basis for
assessing our current business.
As a consequence of the divestiture of a majority of our
business and assets during 2003 and early 2004 and our
acquisition of Amarin Neuroscience in October 2004, our
historical financial results do not form an accurate basis upon
which investors should base an assessment of our business and
prospects. Prior to such divestiture, our business was primarily
the sale of marketable products in the United States, the
out-licensing of our proprietary technologies, and research and
development activities. Following the acquisition of Amarin
Neuroscience, we are now focused on the research, development
and commercialization of novel drugs for the central nervous
system (CNS). Accordingly, our historical financial
results reflect a substantially different business from that
currently being conducted.
8
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 Miraxion 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:
On 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 £7.5 million for each of the two potential
market approvals (i.e., £15.0 million
maximum); and
On 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 million for each of the two potential market
approvals (i.e., GBP£10 million maximum).
In connection with the completion of our May 2005 registered
direct offering of Ordinary Shares, represented by American
Depositary Shares, evidenced by American Depositary Receipts
(ADRs), which raised gross proceeds of
$17.78 million, investors in the offering were given the
future investment right described below.
If, by March 15, 2006, the Company has not raised gross
proceeds of at least $10.0 million (the Future
Financing Amount) from (i) revenues from the
licensing or partnering of the Companys intellectual
property or proprietary information that are receivable prior to
March 15, 2006, (ii) the issuance of Ordinary Shares
at a price per Ordinary Share of at least $2.50
and/or
(iii) funds received by the Company in connection with the
exercise of outstanding warrants, then, at any time between
March 15, 2006 and March 31, 2006, the original
investors in the offering will have a pro rata right to make an
equity investment in the Company at a price per Ordinary Share
equal to the lower of (a) $1.75 and (b) 84% of the
volume weighted average of closing prices of the ADRs on the
Nasdaq Stock Market over the thirty trading days ending on
March 15, 2006, in an amount up to the Future
Financing Amount, less any amounts actually raised pursuant to
clauses (i), (ii) and (iii) above. To the extent
that any investor elects not to take part in such financing, the
unallocated portion of the Future Financing Amount will be
allocated on a pro rata basis among those investors who have
elected to take part in the financings, until all of the Future
Financing Amount has been allocated to investors that wish to
take part in the financing. The Future Financing Amount shall be
reduced on a
dollar-for-dollar
basis to the extent that the gross amount raised in the May
Offering exceeds $15 million.
As the gross proceeds in the offering were $17.78 million,
or $2.78 million in excess of $15 million, the Future
Financing Amount of $10 million is reduced by
$2.78 million to $7.22 million. As set out above, the
$7.22 million can be reduced by earning fees from out
licensing, issuing shares at a price of at least $2.50
and/or
warrants exercises. In December 2005, Amarin closed a license
agreement with Multicell generating an initial fee of $0.5m. In
January 2006, Amarin issued shares at $2.50 generating proceeds
of $2.1 million. In January and February 2006, Amarin
issued 153,000 shares at an average price of $2.88 on the
exercise of options generating proceeds of $441,000. These
transactions reduce the Future Financing Amount to
$4.18 million. Given that 84% of the volume weighted
average of closing prices of the ADRs on the Nasdaq Stock Market
over the thirty trading days ending on March 15, 2006 is
greater than $1.75, the future investment right was priced at
$1.75. As a result, it is expected that approximately
2,387,850 shares will be issued by March 31, 2006 on
the exercise by investors of the future investment right
In connection with the completion of our December 2005 private
placement of Ordinary Shares which raised gross proceeds of
$26.4 million, investors in the offering were issued with
5-year
warrants to purchase 9,135,034 at an exercise price of
$1.43 per Ordinary Share.
We also have outstanding warrants to purchase 500,000 ordinary
shares at an exercise price of $1.90 per share, which were
originally acquired by Elan Corporation plc as part of a debt
re-negotiation and were subsequently sold by Elan to Amarin
Investment Holding Limited, an entity controlled by
Mr. Thomas G. Lynch, our Chairman. We also have outstanding
warrants to purchase 313,234 Ordinary Shares at an exercise
price of $3.48 per share. As at 31 December 2005, we
also have outstanding employee options to purchase 4,821,952
Ordinary Shares at an
9
average price of $3.63 per share. Additionally, in pursuing
our growth strategy we will either need to issue new equity as
consideration for the acquisition of products, or to otherwise
raise additional capital, in which case equity, convertible
equity or debt instruments may be issued. The creation of new
shares would 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.
The Company forecasts having sufficient cash to fund our group
operating activities into the fourth quarter of 2007. In
addition, we intend to obtain additional funding through earning
license fees from partnering our drug development pipeline
and/or
completing further equity-based financings. There is no
assurance, however, that our efforts to obtain additional
funding from these sources will be successful. If efforts are
unsuccessful, there is substantial uncertainty as to whether we
will be able to fund our operations on an ongoing basis. We may
also require further funds in the future to implement our
long-term growth strategy of acquiring additional development
stage and/or
marketable products, recruiting clinical, regulatory and sales
and marketing personnel, and growing 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.
At present we are substantially reliant upon the success of our
principal product, Miraxion. If development efforts for this
product are not successful in either Huntingtons disease
(HD), depression, or any other indication or if
approved by the FDA, if adequate demand for this product 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 and to acquire
additional products, 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
Miraxion for HD, depression, or any other indication, or any
future product, or if there is not adequate demand for any such
product 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 Miraxion.
Miraxion, which is in phase III clinical development for
HD, phase II clinical development for depressive disorders,
and preclinical development for Parkinsons disease is
currently our only product in late-stage development. In order
to successfully commercialize Miraxion, we 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. We are conducting two
phase III clinical studies to support a possible new drug
application, or NDA, for Miraxion for the treatment
of HD. Statistical significance was not achieved in the entire
study patient population in the first phase III study,
however, a trend to significance was observed in the group that
adhered to the protocol and significant results were observed in
the sub-group of patients that had a genetic CAG number of less
than 45. Our ability to commercialize Miraxion for this
indication is dependent upon the success of these development
efforts. If such 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 from Miraxion. Even if we
obtain regulatory approvals, the timing or scope of any
approvals may prohibit or reduce our ability to commercialize
Miraxion 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.
Additionally, the terms of any approvals may not have the scope
or breadth needed for us to commercialize Miraxion successfully.
10
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.
Our long-term strategy involves the development of products we
may acquire from third parties. The success of these efforts is
dependent in part upon the ability of the Company, its
contractors, and its products to meet and to continue to meet
regulatory requirements in the jurisdictions where we 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. 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 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;
|
|
|
|
slower than expected rates of patient recruitment;
|
|
|
|
the inability to observe patients adequately after treatment;
|
|
|
|
changes in regulatory requirements for clinical trials;
|
|
|
|
the lack of effectiveness during clinical trials;
|
|
|
|
unforeseen safety issues;
|
|
|
|
delay, suspension, or termination of a trial by the
institutional review board responsible for overseeing the study
at a particular study site; and
|
|
|
|
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 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 such 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 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.
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 FDAs current
good
11
manufacturing practice requirements. Application holders must
obtain FDA approval for product and manufacturing 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 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 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.
Competition in the pharmaceutical industry is intense and is
expected to increase. If we are successful in completing the
development of Miraxion, we may face competition to the extent
other pharmaceutical companies are able to develop products for
the treatment of Huntingtons disease, depression or
Parkinsons disease. Potential competitors in this market
may 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
may include large, well-established pharmaceutical companies,
specialty pharmaceutical sales and marketing companies, and
specialized neurology companies. In addition, we may compete
with universities and other institutions involved in the
development of technologies and products that may be competitive
with ours. Many of our competitors will likely have greater
resources than us, including financial, product development,
marketing, personnel and other resources. Should a competitive
product obtain marketing approval prior to Miraxion, this would
significantly erode the projected revenue streams for such
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 future products could be 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 Miraxion
and/or
acquiring or developing other marketable products in the future,
we will be obliged to rely upon contract manufacturers to
produce our products. We may not be able to enter into
manufacturing arrangements on terms that are favorable to us.
Moreover, if any future manufacturers 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
12
requirements of other countries. The failure by a future
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 Miraxion and other 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.
We may
not be able to grow our business unless we can acquire and
market or in-license new products.
We are pursuing 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. 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
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 will need to establish
a sales and marketing capability.
At present, we do not have any sales or marketing capability
since all of our products are currently in the development
stage. However, if we are successful in obtaining regulatory
approval for Miraxion, we intend to directly commercialize this
product in the U.S. market. Similarly, to the extent we
execute our long-term strategy of expanding our portfolio by
developing or acquiring additional marketable products, we
intend to directly sell our neurology products in the United
States. In order to market Miraxion and any other new products,
we will need to add marketing and sales personnel who have
expertise in the pharmaceuticals business. We must also develop
the necessary supporting distribution channels. Although we
believe we can build the required infrastructure, we may not be
successful in doing so if we cannot attract personnel or
generate sufficient capital to fund these efforts. Failure to
establish a sales force and distribution network in the United
States would have a material adverse effect on our ability to
grow our business.
The
planned expansion of our business may strain our
resources.
Our strategy for growth includes potential acquisitions of new
products for development and the introduction of these products
to the market. Since we currently operate with limited
resources, the addition of such 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 (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 Valeant and Watson regarding
the respective businesses sold to them, and other matters, and
we undertook to indemnify Valeant and Watson 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
13
Valeant or Watson. 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:
|
|
|
|
|
acquire patented or patentable products and technologies;
|
|
|
|
obtain and maintain patent protection for our current and
acquired products;
|
|
|
|
preserve any trade secrets relating to our current and future
products; and
|
|
|
|
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 and
technical personnel would be detrimental to our ability to
implement our business plan.
We have entered into an employment agreement with our chief
executive officer. The term of this agreement continues in full
force and effect, subject to either partys right to
terminate upon twelve months notice. Our officers and key
employees, other than our chief executive officer, are not
employed for any specified period and are not restricted from
seeking employment elsewhere, subject only to giving appropriate
notice to us.
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
14
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. (API),
conducted all sales and marketing activities with respect to
such product. Although we have not retained any liabilities of
API 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. 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.
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.
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 is not established, but is thought to be consistent
with other fibrotic side effects observed in Permax.
During 2005, five lawsuits alleging claims related to cardiac
valvulopathy and Permax were pending in the United States. Eli
Lilly, Elan, Valeant,
and/or
Amarin were defendants in these lawsuits. As of the present
date, each of these cases has settled. Most of the details of
these settlements are confidential.
One other lawsuit, which alleges claims related to compulsive
gambling and Permax, remains pending in the United States.
Amarin, Eli Lilly, Elan, and Valeant are defendants in this
lawsuit, and are defending against the claims and allegations.
This case is currently in the early stages of discovery. A
similar lawsuit related to compulsive gambling and Permax is
being threatened against Eli Lilly, Elan,
and/or
Valeant, and could possibly implicate Amarin.
The Company has reviewed the position and having taken external
legal advice considers 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 2005.
The price
of our ADSs 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. We currently have approximately
78,935,000 ADSs outstanding. 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
securities. Our ADSs have historically had limited trading
volume, which may also result in volatility. During the
twelve-month period ending February 28, 2006 the average
daily trading volume for our ADSs was 135,847 shares.
15
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 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 future 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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The
rights of our shareholders may differ from the rights typically
afforded 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 Companies
Act 1985, (as amended), 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 a valid 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 pre-emptive
rights to subscribe on a proportionate basis to any issuance of
shares. Under U.S. law, shareholders generally do not have
pre-emptive 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 requirements 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 companys 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 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
16
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.
Foreign
currency fluctuations may affect our future financial results or
cause us to incur losses.
We record our transactions and 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 restrict 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 the pound sterling
and/or the
euro.
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 produce 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 recognize gains from the sale of appreciated
stock, there is a risk that we will be considered a PFIC under
the income test described above. In addition, because of our
cash position, 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 you are urged to consult your own tax advisors
regarding the possible application of the PFIC rules to you in
your particular circumstances.
If we
fail to comply with the terms of our licensing agreement with
Scarista Limited, our licensor may terminate certain licenses to
patent rights, causing us to lose valuable intellectual property
assets.
Under the terms of a licensing agreement between Scarista
Limited and Amarin Neuroscience, our exclusive license to
certain valuable patent rights covering certain of our
technologies may be terminated if we fail to meet various
obligations to Scarista. Under the terms of this agreement we
are obligated to meet certain performance obligations in respect
of the clinical development and commercialization of Miraxion,
payment of royalties, and filing, maintenance and prosecution of
the covered patent rights. In particular, we are obligated to
use our reasonable commercial efforts to pursue the completion
of the Miraxion trials with a view to applying for an FDA
approval for the indication of Huntingtons disease in the
USA. Under the terms of this agreement Scarista is entitled to
terminate this agreement forthwith by notice in writing to the
other if we commit a material breach of this Agreement and fail
to remedy the same within ninety (90) days after receipt of
a written notice of the breach requiring remedy of the same. The
performance of our obligations to Scarista will require
increasing expenditures as the development of Miraxion
continues. We cannot guarantee that we will be capable of
raising the funds necessary to meet our obligations under this
agreement to fulfill these licensing obligations.
17
We do not
currently have the capability to undertake manufacturing of any
potential products.
We have not invested in manufacturing and have no manufacturing
experience. 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. To the extent that we enter into contractual
relationships with other companies to manufacture our products,
if any, the success of those products may depend on the success
of securing and maintaining contractual relationships with third
party manufacturers (and any sub-contractors they engage).
We have secured supply of Miraxion through the expected launch
period of the product. Our ability to meet commercial demand for
Miraxion beyond this quantity would depend on our successfully
obtaining a commitment for such supplies. We are currently in
discussion with the existing and other manufacturers to meet
this requirement. We cannot guarantee that we will be able to
obtain a commitment from the existing contract manufacturer
and/or to
negotiate a second supply agreement with an alternate contract
manufacturer to manufacture additional commercial supplies of
Miraxion. If we were unable to do so, we would be unable to
successfully commercialize Miraxion and our results of
operations and prospects would be materially adversely affected.
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 sub-contractors they engage).
We have
limited personnel to oversee out-sourced clinical testing and
the regulatory approval process.
It is likely that we will also need to hire additional personnel
skilled in the 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, or CROs, and other third parties to
help us develop our drug candidates. Although we have designed
the clinical trials for drug candidates, the CROs 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 CROs may not perform all of their obligations under
arrangements with us. If the CROs 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 CROs devote to our programs or product
candidates. The failure of any of these CROs 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.
18
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 Huntingtons disease and other
neurological disorders. 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 UK, or similar agencies in other countries.
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We are
undergoing significant reorganizational change. Failure to
manage disruption to the business or the loss of key personnel
could have an adverse effect on our business.
As part of our reorganization, we are making significant changes
to both our management structure and the locations from which we
operate. As a result of this, in the short term, morale may be
lowered and key employees may decide to leave, or 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. The benefits of the
reorganisation are expected to be a significant improvement in
operating effectiveness and substantial cost savings.
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Item 4
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Information
on the Company
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A.
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History
and Development of the Company
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Amarin Corporation plc (formerly Ethical Holdings plc) was
incorporated in England as a private limited company on
March 1, 1989 under the Companies Act 1985, a statute
governing companies in Great Britain, (the Companies
Act), and re-registered in England as a public limited
company on March 19, 1993. Our registered office and our
principal executive offices are located at 7 Curzon Street,
London W1J 5HG, England, and our telephone number is
+44-20-7499-9009.
During the period from May 2001 up to February 2004 we had a U.S
sales and marketing subsidiary, Amarin Pharmaceuticals, Inc.
(API), that generated revenues though the sale of a
number of FDA approved pharmaceutical products. Following, the
sale of API and a majority of our U.S products to Valeant in
February, 2004 and the acquisition of the entire issued share
capital of Laxdale Limited in October 2004, the Company is now a
neuroscience company focused on the research, development and
commercialization of novel drugs for the treatment of central
nervous system disorders.
Principal
Divestments Sale of API and Settlement of
Obligations to Elan, Sale of ADAB
In 2003 and early 2004, our former US operations were incurring
substantial operating losses due to the introduction of generic
competition to Permax in December 2002. Also, in early 2004, we
were faced with debt of $31.5 million due on demand to
Elan. In February 2004 we sold our U.S. based subsidiary,
Amarin Pharmaceuticals, Inc. and a majority of our
U.S. products for a purchase price of approximately
$46 million, including $8 million in milestone
payments, to Valeant Pharmaceuticals International
(Valeant). In addition, Valeant assumed certain
other outstanding liabilities, including Amarins
obligation to make a milestone payment to Elan of
$10 million, if sales of Zelapar reach a certain level.
Under the terms of the transaction, Valeant made an initial
payment of $38 million to us for our interest in Amarin
Pharmaceuticals Inc. along with the rights to Amarins
product portfolio, which included
Permax®,
a product indicated for the adjunct treatment of
Parkinsons disease; a primary care product portfolio with
a broad range of indications and
Zelapartm,
an in-licensed, late-stage development product for the adjunct
treatment of Parkinsons disease, which had received an
approvable letter from the FDA.
Simultaneously with the sale to Valeant we reached a full and
final agreement with Elan regarding the settlement of our
renegotiated outstanding financial obligations. Under the terms
of this agreement we paid Elan approximately $17.2 million
in cash on closing of the Valeant transaction, plus a further
payment of $1 million on the successful completion of the
Zelapar safety trials. We also issued a $5 million
5-year loan
note to Elan with capital repayment of $1.5 million in
January 2006, $1.5 million in July 2007 and $2 million
in January 2009. The loan note was also pre-payable by us at any
time, subject to a prepayment fee of $250,000, and carried an
interest rate of 8% per annum. Additionally we issued
500,000 warrants to Elan priced at the average market closing
price for our Ordinary Shares for the
30-day
period prior to closing, being $1.90.
We closed the Valeant transaction on February 25, 2004. As
a result of the asset sale to Valeant, we realized net proceeds
of approximately $6 million after accounting for financial
obligations to Valeant in connection with the sale transaction,
payments to Elan in connection with the debt settlement, and
professional fees and other third party costs relating to the
transaction.
In October 2003, we sold Gacell Holdings AB, the Swedish holding
company of Amarin Development AB (ADAB), our Swedish
drug development subsidiary, to Watson Pharmaceuticals, Inc.,
for approximately $15 million in cash.
Purchase
of Debt and Equity Interest in Amarin by Chairman
On September 30, 2004 Amarin Investment Holding Limited
(AIHL), an entity controlled by our Chairman,
Mr. Thomas Lynch, declared an interest to Amarin in the
following securities in Amarin following their purchase from
Elan Corporation plc and its affiliated companies:
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4,653,819 ADSs;
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Warrants to subscribe for 500,000 Ordinary Shares at an exercise
price of US$1.90 per share; and
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US$5 million in aggregate principal amount of Secured Loan
Notes due 2009, issued pursuant to a loan note instrument dated
February 25, 2004.
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2004
Equity Financing
On October 7, 2004:
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we completed a private placement of 13,474,945 ordinary shares
to accredited investors consisting of new and existing
shareholders and management. Gross proceeds to the Company were
$12.775 million. The purchase price was $0.947 per
share based on the average closing price of our ADSs on the
Nasdaq SmallCap Market for the ten trading days ended
October 6, 2004; however, management investors paid a
purchase price of $1.104 per share based on the average
closing price of our ADSs on the Nasdaq SmallCap Market for the
five trading days ended October 6, 2004. All of the shares
issued in such private placement have been registered pursuant
to a Registration Statement on
Form F-3
that was declared effective by the Securities and Exchange
Commission in January 2005; and
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AIHL redeemed $3 million of the $5 million in
principal amount of loan notes acquired by it and subscribed for
ordinary shares of Amarin at a price of $1.104 per share.
The remaining $2 million in principal amount of the loan
notes was payable in January 2009, and interest thereon accrued
at the rate of 8% per annum and payable on a semi-annual
basis. However, this remaining $2 million was redeemed in
May 2005 see 2005 Equity Financings below.
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Principal
Capital Investments Laxdale
Acquisition
Having completed the sale of API and retained the
U.S. sales and marketing rights to Miraxion for
Huntingtons disease, we were still dependent on our
research and development partner, Laxdale, to successfully
manage the development and regulatory processes for Miraxion. In
addition, in the event of Miraxions approval in the
U.S. for Huntingtons disease we would have been
obliged to pay Laxdale a royalty of 40-45% of net sales.
Thus, in October 2004, we acquired Laxdale, our neuroscience
research and development partner and the originator of Miraxion.
The purchase price for the acquisition of Laxdale comprised an
initial consideration of 3.5 million ADSs representing
3.5 million ordinary shares of 5p each in the capital of
Amarin and certain success based milestone payments described
below, payable on a pro rata basis to the shareholders of
Laxdale. As a result of this transaction Laxdale has become a
wholly owned subsidiary of Amarin. Accordingly, Amarin assumed
Laxdales outstanding net liabilities in the amount of
approximately GBP£1.2 million ($2.2 million),
which included debt obligations in the amount of
GBP£1 million ($1.8 million) to Amarin. We
changed the corporate name of Laxdale to Amarin Neuroscience
Limited on December 24, 2004.
Pursuant to the Laxdale share purchase agreement further
success-related milestones are payable as follows:
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On receipt of a marketing approval in each of the U.S. and/or
Europe for the first indication of any product containing
Laxdale intellectual property, we must make a stock or cash
payment (at the sole option of each of the sellers) of
GBP£7.5 million for each of such two potential market
approvals (i.e. GBP£15.0 million maximum); and
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On receipt of a marketing approval in each of the U.S. and/or
Europe for any other product using Laxdale intellectual property
or for a different indication of a previously approved product,
we must make a stock or cash payment (at the sole option of each
of the sellers) of GBP£5 million for each of such two
potential market approvals (i.e. GBP£10 million
maximum);
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We believe the acquisition of Laxdale had a number of
significant benefits to Amarin including:
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Expanding Amarins rights to Miraxion. Previously, Amarin
had an exclusive licence from Laxdale for the U.S rights to
Miraxion for Huntingtons disease only. The acquisition
gives Amarin North American, European Union and Japanese rights
to Miraxion for Huntingtons disease and a number of other
CNS indications (including depression and Parkinsons
disease);
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Eliminating a 40-45% royalty on US sales of Miraxion for
Huntingtons disease previously payable to Laxdale as
licensor. Total third party royalties now payable by Amarin on
Miraxion for Huntingtons disease were reduced to 6%
(consisting of 5% payable to Scarista Limited and 0.5% payable
to each of Dr. Malcolm Peet and Dr. Krishna Vaddadi);
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Providing Amarin with control of the clinical development and
regulatory process in the U.S and European Union for Miraxion,
rather than being dependent on Laxdale as an independent partner;
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Adding a pipeline of CNS research and development programs and
an extensive lipophillic and combinatorial lipid technology
platform;
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Providing Amarin with an extensive portfolio of intellectual
property covering both its development pipeline and its
technology platform; and
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Bringing Amarin sales and marketing partners for HD in each of
the major European markets and a partner for the Japanese market.
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Pursuant to the Laxdale share purchase agreement, we have agreed
to use reasonable commercial efforts to (i) continue the
phase III trials for Miraxion in Huntingtons disease
and, upon successful completion thereof, pursue FDA approval for
such indication, (ii) pursue approval of Miraxion in Europe
for the treatment of Huntingtons disease, and
(iii) conduct development activities and pursue U.S. and
European approvals for indications other than Huntingtons
disease. Reasonable commercial efforts are defined in the share
purchase agreement as efforts consistent with industry practice
for the development of products of similar performance and
potential. However, we are not required to pursue development
efforts for Huntingtons disease or other indications if
our board of directors reasonably determines in good faith that
it is not commercially or scientifically viable to do so or that
it is not appropriate to continue development due to patient
safety concerns.
In conjunction with our acquisition of Laxdale, Laxdale has
entered into re-negotiated cross-licensing agreements with
Scarista Limited which provide Laxdale with rights to specified
intellectual property covering the United States, Canada, the
European Union and Japan. Scarista has granted a license to
Laxdale pursuant to which Laxdale has the exclusive right to
market, sell and distribute products utilizing certain of
Scaristas intellectual property (including intellectual
property for the use of Miraxion in depressive disorders) within
a field of use encompassing all psychiatric and central nervous
system disorders, and within the territories of the United
States, Canada, the European Union and Japan. As part of such
re-negotiation Scarista is entitled to receive reduced royalty
payments of 5% on all net sales by Laxdale of products utilizing
such Scarista intellectual property and certain of
Laxdales intellectual property (which intellectual
property had been transferred to Laxdale by Scarista in March,
2000). In consideration of Scarista entering into these
agreements and the reduction of Scaristas royalty from 15%
to 5%, Laxdale has paid a signing fee of £500,000
($891,000) to Scarista. The Scarista intellectual property
licensed to Laxdale is material to our development efforts with
respect to Miraxion.
In addition, Laxdale has granted a license to Scarista pursuant
to which Scarista has the exclusive right to market, sell and
distribute products utilizing certain of Laxdales
intellectual property (including intellectual property for the
use of Miraxion in Huntingtons disease) within a field of
use encompassing all psychiatric and central nervous system
disorders, and on a worldwide basis in all territories other
than the United States, Canada, the European Union and Japan.
Laxdale is entitled to receive royalty payments of 5% on all net
sales by Scarista or its licensees of products utilizing such
Laxdale intellectual property. Under each of these license
agreements royalties are payable until the latest to occur of
(i) the expiration of the last patent relating to any
product using the licensed technology, (ii) the expiration
of regulatory exclusivity with respect to any product using the
licensed technology; or (iii) the date on which the
licensed technology ceases to be secret and substantial in a
given territory. Upon the termination of royalty payment
obligations with respect to any product, the licensee will
thereafter have a fully paid up, royalty free, non-exclusive
license to continue using the licensed technology in respect of
such product.
Miraxion has been partnered for Huntingtons disease in the
majority of the major European Union markets. Additionally,
Laxdale has licensed out the right to develop, use and sell
products incorporating certain of its intellectual property in
Japan for the treatment of certain central nervous system
disorders (including Huntingtons disease, schizophrenia
and depression).
22
Current
Business
The sale of our
U.S.-based
subsidiary, Amarin Pharmaceuticals, Inc. and a majority of our
U.S products to Valeant in February, 2004 and the acquisition of
the entire issued share capital of Laxdale Limited in October
2004 have refocused the nature of the Companys business to
a neuroscience company focused on the research, development and
commercialization of novel drugs for the treatment of central
nervous system disorders.
Development
Pipeline
During 2005, Amarin made significant progress with its
development pipeline. In the first quarter, we announced
positive data analysis from three clinical studies that
indicated that Miraxion showed a significant benefit for those
depression patients with melancholic features. As a result of
this data, Amarin intends to further evaluate Miraxion in
depression and is seeking a development and marketing partner to
accelerate this program. See
Item 4B Business
Overview Miraxion for Depressive Disorders.
In September, 2005 Amarin reached an agreement with the
U.S. Food and Drug Administration (FDA) under the Special
Protocol Assessment (SPA) procedure for the design of two
pivotal phase III clinical trials of Miraxion in
Huntingtons disease. The Special Protocol Assessment (SPA)
is a process under which the FDA provides evaluation and
guidance on clinical trial protocols for phase III trials.
The US phase III trial commenced recruitment in September
and the EU phase III trial in December 2005. See
Item 4B Business
Overview Miraxion for Huntingtons disease.
Shortly after the year end, Amarin also announced preliminary
results from pre-clinical studies indicating that Miraxion has
neuroprotective effects in Parkinsons disease. See
Item 4B Business
Overview Miraxion for Parkinsons Disease.
In addition, in December, Amarin licensed exclusive worldwide
rights to MCT-125 (formerly LAX 202), our
phase II program in Multiple Sclerosis, to Multicell
Technologies, Inc (Multicell). See
Item 4B Business
Overview MCT 125.
2005
Equity Financings
In May, 2005, we accepted subscriptions of $17.8 million
from institutional and other accredited investors, including
certain directors and executive officers of Amarin, for
13.7 million American Depositary Shares in a registered
direct offering at a purchase price of $1.30 per share.
Directors and executive officers of Amarin purchased an
aggregate of 3.5 million shares in the offering, inclusive
of the 1.5 million shares issued on redemption of the loan
notes, representing a total investment of approximately
$4.5 million. On closing of this transaction AIHL redeemed
the remaining $2 million in principal amount of its 8% loan
notes issued by Amarin and used the proceeds of the redemption
together with a further $250,000 to subscribe for shares in this
offering. At closing of this offering, following the redemption
of the $2 million in aggregate principal of loan notes,
Amarin had no debt other than working capital liabilities.
In December, 2005, Amarin entered into definitive purchase
agreements for a private equity placement, consisting of
ordinary share and warrants, resulting in gross proceeds of
$26.4 million. In accordance with the terms of the
financing, Amarin sold approximately 26.1 million Ordinary
Shares at $1.01 per share and issued warrants to purchase
approximately 9.1 million ADSs at an exercise price of
$1.43 per share. Investors in this private placement
included Southpoint Capital Advisors LP, Biotechnology Value
Fund LP, Fort Mason Capital LP, Domain Public Equity
Partners LP and other new and existing institutional and
accredited investors, including certain directors and executive
officers of Amarin. This successful financing provides Amarin
with sufficient funding to complete the US and European
Huntingtons disease phase III trials currently in
progress with our lead product Miraxion, which are due to
complete in late 2006 or early 2007.
23
Our
Business
Amarin is a neuroscience company focused on the research,
development and commercialization of novel drugs for the
treatment of central nervous system disorders. Amarins
leading pipeline product, Miraxion is in phase III
development for Huntingtons disease (HD), in
phase II development for depressive disorders and
preclinical development for Parkinsons disease. Miraxion
has been granted fast track designation by the U.S Food and Drug
Administration (FDA) for HD and has received orphan
drug designation in the U.S and Europe. Amarin is listed on the
Nasdaq Capital Market (ticker: AMRN) and has headquarters in
London.
Amarins goal is to capitalize on its reputation in
neurology and to become a leader in the development and
commercialization of novel drugs which address unmet medical
needs. We intend to directly commercialize our neurology
products in the U.S. and out-license or partner our product
rights in Europe and Japan. We also intend to out-license or
partner our pipeline globally for indications outside neurology,
including depressive disorders.
Amarin anticipates that future revenues will comprise
(i) direct product sales in the U.S. from
self-marketed neurology products; and (ii) milestones and
royalty income from its development and marketing partners for
markets outside the U.S. and for indications other than in the
field of neurology.
Amarin also intends to leverage its development capabilities by
supplementing its internal development pipeline through
acquiring
and/or
in-licensing products that it can develop or market directly
itself in the U.S.
Therapeutic
Focus
Neurology is a therapeutic area with significant unmet needs,
comprising diseases and disorders such as HD, Parkinsons
disease, ALS, ataxias, dystonias, Alzheimers, impaired
cognition, epilepsy and multiple sclerosis. With approximately
7,200 neurologists across the U.S., one thousand of whom are
movement disorder specialists, effective marketing can be
conducted with a sales force of modest size. Amarin has been
focused in neurology for over five years and, having previously
operated a neurology sales and marketing infrastructure in the
U.S., we believe has an established presence and reputation in
this field.
Lipophilic
Technology Platform
Amarin is using a novel, proprietary technology platform based
on an understanding of the chemical nature of the brain. Unlike
most organs, the brain is 60% fat (phospholipid) and only 30%
protein. In general, just as oil and water do not mix, most
drugs which easily dissolve in water do not readily penetrate
the brain. Amarins lipophilic drugs are predominantly
fat-soluble and may therefore more easily cross the blood brain
barrier.
Most current drugs for treating neurological and psychiatric
disorders have mechanisms of action targeting receptors (surface
proteins embedded in the phospholipid membranes) or
neurotransmitters in the brain. Amarins novel proprietary
technology targets the bio-chemical imbalances in the
phospholipids themselves and also influences other fatty acid
and eicosanoid pathways. Amarins first lipophilic product,
Miraxion, is in clinical development for Huntingtons
disease and depressive disorders and is in preclinical
development for Parkinsons disease.
Combinatorial
Lipid Technology Platform
Combinatorial lipid chemistry offers a novel approach to
improving the therapeutic effects and delivery characteristics
of both known and novel compounds. Amarin studies the use of
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. Amarin intends
to select at least one lead candidate for further pre-clinical
testing in 2006.
24
Development
Pipeline
The following table summarizes the status of our development
pipeline:
|
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|
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Program
|
|
Indication
|
|
Status
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Partners
|
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Lipophilic
Platform
|
|
|
|
|
|
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Miraxion
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Huntingtons Disease
|
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phase III
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Scil Biomedical GmbH (Germany,
Austria, France, Benelux)
Juste S.A.Q.F. (Spain, Portugal)
Link Pharmaceuticals Ltd (UK, Ireland)
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Miraxion
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|
Depressive Disorders
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|
phase II
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Partner discussions on-going
|
Miraxion
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Parkinsons Disease
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|
pre-clinical
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Combinatorial Lipid
Platform
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Various
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CNS Disorders
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pre-clinical
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LAX-200 Series
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LAX-201
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Major Depression in Women
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phase II
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Seeking Partner
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MCT-125
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Multiple Sclerosis Fatigue
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phase II
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Multicell Technologies,
Inc.(worldwide)
|
Additionally, we have assumed from Laxdale a license agreement
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
Huntingtons disease, depression, schizophrenia, dementia
and other CNS indications.
Miraxion
Miraxion is a semi-synthetic, highly purified derivative of
(all-cis)-5,8,11,14,17-eicosapentaenoic acid
(Ethyl-EPA). The mechanism of action of Miraxion and
its metabolites is believed to involve stabilization of cell
membranes and of mitochondrial integrity of
suffering neurons, thereby preventing or slowing
progression from neuronal dysfunction to apoptosis. It is also
known to have neuro-anti-inflammatory effects.
Miraxion
for Huntingtons disease
Miraxion has been granted fast track designation by the FDA for
HD and has received orphan drug designation in the U.S. and
Europe. Fast track status generally sets the FDAs
review-time goal for the filed New Drug Application (NDA) at six
months, which is faster than the typical review period for most
non-fast track drugs. Fast track status does not however
guarantee a specific review time or a pre-determined outcome.
Orphan drugs are those that treat rare diseases or conditions,
and if approved receive marketing exclusivity of seven years in
the U.S. and up to ten years in Europe. However, orphan drug
exclusivity does not bar competitors from developing products
containing the same active molecule for different applications
or other active molecules for the same indication. In addition,
the same molecule can be separately developed and approved
within such special exclusivity period for the same indication
if it is offered in a form that is shown to be clinically
superior to Miraxion or if the Company is unable to supply
sufficient quantities of Miraxion. Orphan drug status does not
confer patent rights upon the holder, nor does it provide an
exemption from claims of infringement of patents which may be
held by third parties.
HD is a genetic neurodegenerative disease characterized by
movement disorder, dementia and psychiatric disturbance. It has
been diagnosed in approximately 30,000 patients in the U.S.
and a similar number in Europe. Additionally, over 200,000
people in the U.S. alone are genetically at
risk of developing the disease. Onset of symptoms is
typically between 30-50 years of age with a typical life
expectancy from diagnosis of 10-25 years. Patients with
late stage disease require continuous nursing care, often in
nursing homes, with an estimated annual cost to the
U.S. economy of up to $2.5 billion. Presently, there
is no effective treatment or cure. The potential HD market for a
therapeutic in North America and Europe is estimated to be
greater than $500 million per year.
25
Following positive results in phase II studies for
Miraxion, Laxdale conducted a 135 patient phase III
double-blind placebo-controlled study. Statistical significance
was not achieved in the entire patient population in this study.
However, in those patients that complied with the protocol
(per protocol), a trend to statistical significance
was observed.
Amarin had pre-specified in the protocol of the phase III
trial that it would examine the response of HD patients to
Miraxion based on their genetic makeup. Huntingtons
disease is believed to be caused by a genetic mutation of
cytosine, adenosine and guanine (CAG) polymorphic trinucleotide
repeats. It is believed that there is a direct link between CAG
repeat length and age of onset, disease progression and the
clinical symptoms of Huntingtons disease. CAG repeat
length can be measured by a genetic blood test. The further
analysis of the clinical data from the phase III study
found that the group of patients with a CAG repeat length of
less than or equal to 44 receiving Miraxion showed a
statistically significant improvement over those patients
receiving placebo.
The trial was conducted across six centres. An analysis of the
data on a centre by centre basis illustrated that
Miraxions effectiveness in the group of patients with a
CAG repeat length less than or equal to 44 was consistent across
centres, i.e. Miraxion worked better in patients with a CAG
repeat length less than or equal to 44 than in patients with a
CAG repeat length greater than 44 and that Miraxion worked
better than placebo in patients with CAG repeat length less than
or equal to 44. In total, 67 of the 135 patients in the
initial phase III study had this specific gene variant. It
is estimated that patients with a CAG repeat length of less than
or equal to 44 represent approximately 70% of all
Huntingtons disease patients.
Based on the data in this genetic sub-group Amarin planned
further phase III clinical trials in the U.S. and Europe
and these have now commenced. The U.S. and European trials are
multi-centre, randomized, double blind,
placebo controlled studies at 43 sites in the
U.S. and up to 33 sites in Europe. The trials are expected to
involve a total of up to 540 Huntingtons disease patients
with approximately 300 in the U.S. phase III clinical
trial and approximately 240 in the European phase III
clinical trial over a 6 month period. The clinical trials
are being conducted under a Special Protocol Assessment (SPA)
procedure that was granted by the FDA in September 2005. The SPA
is a process under which the FDA evaluates and provides specific
guidance on pivotal clinical trial protocols for phase III
trials.
The Huntington Study Group (HSG), based at the University of
Rochester, is conducting the U.S. clinical trial on behalf
of Amarin. The HSG is a non-profit group of physicians and other
health care providers from medical centres in the U.S., Canada,
Europe and Australia, experienced in the care of
Huntingtons disease patients and dedicated to clinical
research of Huntingtons disease. The European clinical
trial is being conducted in collaboration with EURO-HD and Icon,
a leading contract research organization (CRO). EURO-HD is a
non-profit group of physicians and other healthcare
professionals dedicated to the research and care of
Huntingtons disease patients.
The important lessons learned from the initial phase III
trial all have been incorporated into the design and conduct of
the two phase III trials currently underway, including:
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Sub-group of
potential responders to Miraxion identified; i.e. those patients
with a CAG repeat length of less than or equal to 44
(representing approximately 70% of the HD patient population).
Patient entry criteria are designed to ensure the vast majority
of patients in the trial will be those previously identified as
potential responders.
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The importance of protocol compliance:
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The two studies underway will be conducted across over 70
centres compared to only 6 centres in the initial study. This
will make it easier for patients to make their monitoring
meetings within the timeframe set out in the protocol and
significantly reduces the number of patients per centre for the
trials;
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Patients will be evaluated and monitored more frequently in the
current trial; and
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|
In the U.S. study, patients who complete the
6-month
blinded phase will have the opportunity to enter a 6 month
extension of the study where all patients will take Miraxion and
be assessed further at the
12-month
time-point. In addition to providing further data, the
6-month
extension is aimed to improve the speed of recruitment and to
encourage those in the trial who feel they may be on placebo to
complete the initial 6 month trial period.
|
26
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The size of the studies has been substantially increased. The
initial phase III trial had an ITT group of
135 patients and a per protocol group of 83. The current
trials plan to recruit 300 patients in the U.S. and
240 patients in Europe.
|
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Extensive feedback obtained from FDA and EMEA.
|
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The importance of engaging the world leaders in treating and
studying HD by contracting with HSG to conduct the
U.S. phase III trial and by collaborating with EURO-HD
in conducting the European phase III trial.
|
Miraxion has a strong safety profile. Over the course of the
initial one year phase III trial, only one patient of 135
dropped out because of a treatment related side effect
(gastrointestinal upset) and all but one patient who completed
the trial opted to continue in an open label study for a second
year.
Miraxion
for Depressive Disorders
Clinical depression is one of the most common mental illnesses,
affecting more than 19 million people in the
U.S. alone each year. U.S. sales of antidepressants
approximate $14 billion annually. However, about one third
of patients with depression still fail to respond to standard
drugs and another third show only partial response. More than
half of Americans affected by a depressive disorder suffer from
major depressive disorder (MDD), with the remainder suffering
from dysthymic disorder (chronic mild depression).
Melancholic depression represents one of two subtypes of MDD
recognized by the Diagnostic and Statistical Manual of Mental
Disorders (DSM-IV), the main diagnostic reference of mental
health professionals in the U.S. (published by the American
Psychiatric Association, Washington D.C.). While considered one
of the most severe forms of the disease, it is by no means
uncommon and is a widely accepted diagnosis. In fact, nearly
one-quarter of patients with MDD exhibit melancholic features.
Melancholic depression is currently treated similarly to MDD.
In total six phase IIa placebo-controlled studies have been
conducted with Miraxion in depressive disorders, with each
showing a benefit in favor of Miraxion. Three of the studies
were investigator-lead with each showing a statistically
significant benefit for Miraxion in the primary outcome. Two
published phase IIa placebo controlled clinical trials have
been conducted with Miraxion in treatment-unresponsive
depression that concluded with statistical significance that
Miraxion was effective in treating depression in patients who
remained depressed despite receiving standard therapy. The
results of these trials were published in the Archives of
General Psychiatry in October 2002 (volume 59, Peet &
Horrobin) and the American Journal of Psychiatry in March 2002
(volume 159, Belmaker).
A further program of data analysis was carried out on three
Laxdale led studies. The data analysis indicated that Miraxion
showed a significant clinical benefit in each of the three
studies for those depression patients with melancholic
characteristics. This sub-group of melancholic depression
patients was defined by using select criteria from DSM-IV. As a
result of these data, Amarin intends to further evaluate the
clinical benefits of Miraxion in depression and intends to seek
a development and marketing partner to accelerate this program.
There is currently no approved treatment specifically indicated
for melancholic depression and nothing as far advanced in
clinical studies as Miraxion, so far as the Company is aware.
Thus, should Miraxion receive approval, it could become the
first and only treatment for specifically melancholic
depression. Given its favorable safety profile and potential
efficacy in the most severe patient population, Miraxion may
also be appropriate for study outside the melancholic subset of
the broader MDD population.
Miraxion
for Parkinsons Disease
Parkinsons disease (PD) is a progressive
neurodegenerative disorder affecting approximately
1 million patients in the U.S. where the market for PD
drug treatments in 2004 was approximately $600 million. The
main pathological characteristic of PD is the loss of pigmented
dopamine-containing neurons of the substantia nigra associated
with the presence of cytoplasmic a-synuclein- positive
inclusions, the so-called Lewy bodies.
27
Therapeutics that slow or stop the neurodegenerative processes
of PD are expected to have a major impact for the treatment of
PD.
Recently announced preliminary results from pre-clinical studies
indicate that Miraxion has neuroprotective effects in PD. The
first study showed Miraxions neuroprotective effects in
cell lines associated with PD. SH-SY5Y cells, derived from human
neuroblastoma, with many properties similar to dopaminergic
neurons, are widely utilized as an in vitro model to study
effects and mode of action of drugs on PD.
Brain-derived neurotrophic factor (BDNF) and its receptor
transmembrane tyrosine-specific protein kinase (TrkB) are linked
to the etiology of neurodegenerative and mood disorders. The
study of fully differentiated SH-SY5Y cells revealed that
Miraxion increased the activation of TrkB and truncated TrkB
messenger RNA (mRNA) expressions which are critical functions
for increasing dopamine (DA) levels in PD patients. The data
showed that Miraxion demonstrated neuroprotective effects by
interacting with BDNF, leading to improved cell viability and
the slowing of the neuronal apoptosis (cell death) associated
with the symptoms of PD.
The second study demonstrated that Miraxion modulated cellular
function in MPP+ treated SH-SY5Y cells in an in vitro PD
model and behavior in an MPTP-induced PD model. MPTP is a
neurotoxin commonly used to investigate PD in pre-clinical
models. MPP+ is a metabolite of MPTP. In this study, treatment
with Miraxion enhanced learning performance, improved motor
function and reduced bradykinesia in such animal models. Amarin
is currently continuing preclinical studies in PD and plan to
commence human studies in 2006.
LAX-201
LAX-201 is a patent-protected combination of folic acid and
either of two leading classes of anti-depressant drugs (i.e.
Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin
Norepinephrine Reuptake Inhibitors (SNRIs). A phase II
study showed LAX-201 increased the response rate in depressed
women from 50%-60% to approximately 90%. Amarin is currently
seeking a development partner for this product.
MCT-125
(formerly LAX- 202)
MCT-125 is a patent-protected combination of an atypical
antidepressant and an amino acid. In a
138-patient,
multi-centre, double-blind placebo controlled phase IIb
trial MCT-125 was effective in significantly reducing the levels
of fatigue in multiple sclerosis patients. Amarin has licensed
world wide rights to MCT-125 to Multicell in return for a series
of development based milestones and a royalty on net sales.
Multicell renamed LAX-202 as
MCT-125.
Amarins
Marketing Partners
Miraxion for Huntingtons disease has been partnered in the
major EU markets. Our marketing partners are identified in the
development pipeline table as above. Our EU partnering
agreements take the form of a license and distribution
agreement. This provides for the grant of a license to market,
distribute and sell products in the partners territory in
the pharmaceutical field of Huntingtons disease and
certain smaller CNS indications utilizing certain of our
intellectual property for a period of 10 years from signing
or, if later, until the expiration of patent or orphan drug
protection for the product. The grant of such license is in
return for the commercial partner paying to Amarin Neuroscience
(i) fixed milestone payments;
and/or
(ii) an exclusive supply arrangement;
and/or
(iii) a royalty on net sales made by the commercial partner.
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 Huntingtons disease, depression,
schizophrenia, dementia and certain smaller 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 good faith reasonable
efforts to develop and commercialize MCT-125.
28
Amarins
short-term objectives
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To file an NDA for Miraxion in Huntingtons disease in the
first half of 2007;
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To obtain a U.S. and EU partner on depressive disorders in
2006; and
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To commence additional clinical programs for another indication
from internal pipeline or in-licensing/acquisition in 2006.
|
The
Financial Year
Our consolidated revenues in 2005 were derived from the
licensing of exclusive, worldwide rights to LAX-202 for the
treatment of fatigue in patients suffering from multiple
sclerosis (MS).
Broken down by geographic markets, for the year ended
December 31, 2005 all revenues originated in the United
Kingdom. Our consolidated revenues in 2004 were derived from two
principal sources relating to discontinued activities. For the
year ended December 31, 2004, sales of our products through
our former sales and marketing operations accounted for
approximately 91% of total revenues and royalties on third party
product sales accounted for approximately 9% of total revenues.
No revenues were generated from licensing, development or
contract manufacturing fees.
Our consolidated revenues in 2003 were derived from four
principal sources, all discontinued as at 31 December 2005.
For the year ended December 31, 2003, sales of our products
through our own sales and marketing operations accounted for
approximately 36% of total revenues; licensing and development
fees accounted for approximately 24% of total revenues; contract
manufacturing fees accounted for approximately 20% of total
revenues; and royalties on third party product sales accounted
for approximately 20% of total revenues. Although some of the
products marketed in the US showed seasonal market trends, our
consolidated group did not experience any material revenue
seasonality. Broken down by geographic markets, for the year
ended December 31, 2003 approximately 36% of total
consolidated revenues were generated in the US, representing
sales of our pharmaceutical products; approximately 1% of total
consolidated revenues were generated in the UK, representing our
royalty income; and approximately 63% of total consolidated
revenues were generated in the European market, representing our
drug delivery and contract manufacture business.
During 2003 and 2004, all of our revenue-producing products and
services were divested. At present all of our products are in
the development stage and we therefore have no products that can
be marketed.
Competition
In pursuing our strategy of acquiring marketable
and/or
development stage neurology products, we expect to compete with
other pharmaceutical companies for product and product line
acquisitions, and more broadly for the distribution and
marketing of pharmaceutical and consumer products. These
anticipated competitors include companies which may also seek to
acquire branded or development stage pharmaceutical products and
product lines from other pharmaceutical companies. Most of our
potential competitors will likely 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
competitive 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 Miraxion 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
29
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. Good laboratory practice
requirements must be followed in order for the resulting data to
be considered valid and reliable. 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 I, phase II and phase III clinical trials.
In phase I, generally, a small number of healthy human
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 II 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 III 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 or, generally, for submission in support of a
US marketing application, an investigational new drug
application, or IND, is filed with the FDA. Similar
notifications are required in other countries. The amount of
data that must be supplied in the IND application depends on the
phase of the study. Earlier investigations, such as phase I
studies, typically require less data than the larger and
longer-term studies in phase III. A clinical plan must be
submitted to the FDA prior to commencement of a clinical trial.
In general, studies may begin in the US without specific
approval by the FDA
30-days
after submission of the IND. However, the FDA 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 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 beginning 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, is 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 developed 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 do
not differ significantly from those of other countries, the
amount of detail required by the FDA can be more extensive. In
addition, it is likely that the FDA will re-analyze the clinical
data, which could result in extensive discussions between us and
the licensing authority during the review process. The
processing of applications by the FDA is extensive and time
consuming and may take several years to complete. The FDAs
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 a company in its efforts to obtain FDA
approvals. The FDA may also
30
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 US, 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 US, 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 UK 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 only through one of two 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 products 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 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 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 US, 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
31
use. Use of volatile materials may lead to FDA enforcement
actions. Any distribution of prescription drug products and
pharmaceutical samples must comply with the US Prescription Drug
Marketing Act, or the PDMA, a part of the US Federal Food, Drug,
and Cosmetic Act.
In the US, 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 if 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
US, 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 US Medicare-Medicaid
Anti-Fraud and Abuse Act and similar state laws. Pricing and
rebate programs must comply with the Medicaid rebate
requirements of the US 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 US Controlled
Substances Act and Controlled Substances Import and Export Act.
Products must meet applicable child-resistant packaging
requirements under the US 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:
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changes to our manufacturing arrangements;
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additions or modifications to product labeling;
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the recall or discontinuation of our products; or
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additional record-keeping.
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If any such changes were to be imposed, they could adversely
affect the operation of our business.
32
Manufacturing
and Supply
Amarin Neuroscience Limited is currently responsible for the
supply of the clinical supplies of Miraxion, through its
sub-contractors, and will be responsible for the commercial
manufacturing and supply of Miraxion should the FDA approve this
compound. All supplies of the bulk compound
(ethyl-eicosapentaenoate (ethyl-EPA)) which constitutes
the only pharmaceutically active ingredient of Miraxion are
currently purchased exclusively 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 marine life. 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 95%. We are aware that certain other
manufacturers have the ability to produce Ethyl-EPA to a similar
pharmaceutical standard and level of purity. Once approved, use
of bulk compound produced by a different manufacturer than that
specified and qualified in the NDA may require extensive
additional testing and supplemental approval by the FDA.
Patents
and Proprietary Technology
We firmly 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:
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any patents will be issued for Miraxion or any future products
in any or all appropriate jurisdictions;
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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.
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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.
Currently, Amarin has applied for 321 patents worldwide and
has 115 issued patents covering various of our compounds and
their uses. These include use patents issued for the method of
treating a number of CNS and cardiovascular disorders with
Ethyl-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, 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.
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C.
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Organizational
Structure
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Following the sale of Gacell Holdings AB and its wholly owned
subsidiary Amarin Development AB on October 28, 2003, the
sale of API on February 25, 2004 and the acquisition of
Laxdale Limited on October 8, 2004, all of our commercial
activities are carried out through Amarin Corporation plc and
our subsidiaries Amarin Neuroscience Limited (formerly known as
Laxdale Limited), and Amarin Pharmaceuticals Ireland Limited.
33
Details of all of our significant subsidiaries are summarized
below:
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Proportion of
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Country of Incorporation
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Ownership Interest and
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Subsidiary Name
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or Registration
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Voting Power Held
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Amarin Neuroscience Limited
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Scotland
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100
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%
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Amarin Pharmaceuticals Company
Limited
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England and Wales
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100
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%
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Amarin Pharmaceuticals Ireland
Limited
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Ireland
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100
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%
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D.
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Property,
Plant and Equipment
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The following table lists the location, use and ownership
interest of our principal properties as of March 31, 2006:
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Size
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Location
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Use
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Ownership
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(sq. ft.)
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Ely, Cambridgeshire, England
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Ground Floor
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Offices
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Leased and sub-let
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7,135
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First Floor
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Offices
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Leased and sub-let
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2,800
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Godmanchester,
Cambridgeshire, England
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Offices
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Leased and sub-let
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7,000
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London, England
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Offices
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Leased
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2,830
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Stirling, Scotland
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Offices
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Leased
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7,544
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Dublin, Ireland
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Offices
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Leased
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1,130
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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
2,830 square feet of office space located at 7 Curzon
Street, London, Mayfair, W1J 5HG, England, to serve as our
corporate head office. This lease expires in March 2010.
We occupy office space of approximately 1,130 square feet
at 50 Pembroke Road, Ballsbridge, Dublin 4, Ireland. The
draft lease, awaiting signature, expires in June 2007.
On June 1, 1998, Laxdale signed a lease covering
7,544 square feet of office space located at Units 1
and 3, Laurelhill Park, Kings Park, Stirling,
Scotland. The lease term expires in April, 2013 although there
is a break clause which permits Laxdale to terminate the lease
in January, 2007 without compensation payable for early
termination for the lease should it so wish. Following the
decision to relocate our research and development function from
Stirling to Oxfordshire and to close our research facility in
Stirling, Scotland we gave nine months written notice to
the landlords of the Stirling premises and this lease will
therefore terminate as at December 31, 2006.
We believe that our facilities are sufficient to meet our
current and immediate future requirements. We have no
manufacturing capacity at any of the above properties.
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Item 4A
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Unresolved
Staff Comments
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Not Applicable
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Item 5
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Operating
and Financial Review and Prospects
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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.
34
Comparison
of Fiscal Years Ended December 31, 2005 and
December 31, 2004
Overview
While 2004 was a year of transformation for
Amarin with the sale of our US business, the
settlement of all outstanding obligations to Elan and the
acquisition of Laxdale 2005 was a year of
consolidation. The Company achieved its critical objectives of
advancing its development pipeline and securing adequate funding
to bring Miraxion through its two phase III trials in
Huntingtons disease.
Key
Highlights
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Equity Financing gross proceeds raised of
$46.3 million during the nine-month period ending
January 31, 2006, including directors and officers of
Amarin investing approximately $7.0 million;
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SPA for Huntingtons disease agreement
reached with the US Food and Drug Administration (FDA) in
September under the Special Protocol Assessment (SPA) procedure
for the design of the phase III clinical trials in
Huntingtons disease (HD) with Miraxion; an SPA
is a process under which the FDA provides evaluation and
guidance on clinical trial protocols;
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Miraxion in HD patient enrolment commenced for
the Phase III clinical trials of Miraxion in HD in the US
in September and in the EU in December;
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Miraxion in depressive disorders positive data
analysis announced from the phase II program with Miraxion
in depressive disorders in January and March; Amarin is
currently making good progress in discussions with several
potential development and marketing partners for the US and EU
markets;
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Neuroprotective Effects of Miraxion Miraxion
demonstrated in preclinical models effects that may protect the
brain from inflammation (which is often associated with a number
of neurodegenerative diseases, including Alzheimers,
Parkinsons, and HD) and showed a decrease in the
age-related learning and memory decline accompanied by the
inflammatory changes associated with neurodegenerative diseases;
the full results of the preclinical studies were presented in
November at the 35th Annual Society for Neuroscience
meeting;
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Miraxion in Parkinsons disease Miraxion
demonstrated as having potential neuroprotective effects and the
ability to modulate cellular function in cell lines and
preclinical models of Parkinsons disease;
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Outlicensing of LAX-202 exclusive worldwide
rights of LAX-202 licensed for the treatment of fatigue in
patients suffering from multiple sclerosis (MS) to Multicell
Technologies Inc. (Multicell) in December for an
initial access fee, future development milestones and sales
royalties; Multicell will rename LAX-202 to MCT-125, and will
further evaluate MCT-125 in a pivotal Phase IIb/III
clinical trial which is expected to begin during 2006;
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Management Appointments four senior management
and board appointments made in the last 9 months, further
strengthened the Amarin management team; Dr. Anthony Clarke
as Vice President of Clinical Development; Dr. Prem Lachman
and Dr. John Climax as non-executive director; and Tom
Maher as General Counsel and Company Secretary with effect from
February 2006; and
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For the year ended December 31, 2005, Amarin reported a net
loss of $18.7 million or 40 cents per ADS, compared with
net income of $4.7 million or 21 cents per ADS for the year
ended December 31, 2004. The results for the year ended
December 31, 2005 entirely represent continuing activities.
The results for the year ended December 31, 2004 represent
both continuing and discontinued activities.
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Continuing
Operations
For the year ended December 31, 2005, the operating loss
was $18.9 million, compared with an operating loss of
$9.9 million from continuing activities for the same period
in 2004. The increase is primarily due to the inclusion of
Amarin Neurosciences operating expenses of
$6.8 million ($5.9 million of which relates to
research and development, including the costs of conducting
Miraxions phase III trials in HD) in the nine month
period to
35
September 30, 2005. Amarin Neuroscience was acquired in
October 2004 so the first three quarters expenses are not
included in the 2004 comparative figures.
During 2005, we commenced US and EU Phase III trials for
Miraxion in HD. These trials will continue through 2006 and we
expect this expense to account for a significant portion of our
total expenditure in 2006.
The results for the comparative year ended December 31,
2004 for continuing activities represent Amarins head
office operating expenses, including the cost of business and
corporate development activities and Amarin Neurosciences
results for the period from October 9, 2004 to
December 31, 2004.
Revenue
We had no marketable products during 2005, all of the
Companys marketable products having been divested as part
of the sale of our US business in February 2004. In 2005, Amarin
licensed the exclusive, worldwide rights to LAX-202 for the
treatment of fatigue in patients suffering from multiple
sclerosis and received an initial access fee of
$0.5 million. Revenues in 2004 and 2003 entirely relate to
our two divested businesses, API and ADAB, and have been
classified as discontinued activities.
At December 2005, our business consisted of corporate offices in
London, a subsidiary in Dublin, Ireland and a neuroscience
research and development subsidiary based in Stirling, Scotland
(shortly to be relocated to Oxfordshire in England). In 2006,
Amarin should continue to receive milestone payments from the
Multicell agreement. In 2006, Amarins only additional
revenue from its existing activities, if any, will be from
earning up front license fees from partnering its development
pipeline, such as a license of Miraxion for depression.
Operating
Expenses
Total operating expenses for the continuing business were
$19.4 million compared to $9.9 million in 2004 and
$6.2 million in 2003, an increase of approximately 95.96%
and 59.68% respectively.
Research and Development. Research and
development expenses consist primarily of external clinical
trial costs and salaries and benefits of research and
development personnel. Research and development expenses were
$8.3 million compared to $1.0 million in 2004. The
increase was primarily due to the inclusion of Laxdales
expenses for the full year to December 31, 2005 compared to
only for the post-acquisition period from October 9, 2004
to December 31, 2004 in the comparative period. In
addition, we commenced two phase III trials with Miraxion
in Huntingtons disease, the US trial in September 2005 and
the EU trial in December 2005.
Selling, General and Administrative. Selling,
general and administrative expenses consist primarily of
salaries and benefits earned by selling, general and
administrative personnel, personnel-related overhead allocation,
professional fees and facility costs. Selling, general and
administrative expenses were $9.8 million in 2005 compared
to $7.5 million in 2004. The increase was primarily due to
increased intellectual property, additional staff costs and
facility costs of vacant property.
Restructuring
Charge
During 2005, we recorded restructuring charges to align our
business for maximum efficiency. Our restructuring plan, once
completed, will result in a reduction in headcount and the
relocation of research and development function to Oxfordshire
in England. In determining the charges to record, we made
certain estimates and judgments surrounding the amounts
ultimately to be paid for the actions we have taken or are
committed to take. At December 31, 2005, there were various
accruals recorded for the costs to terminate employees
contracts and exit certain facilities and lease obligations,
which may be adjusted periodically for either resolution of
certain contractual commitments or changes in estimates.
Amortization
Amortization attributable to continuing operations relates to
Miraxion and is included in selling, general and administrative
expenses. During November 2000, Amarin acquired limited rights
to Miraxion as a licensee. On the date of acquiring Laxdale, the
intangible fixed asset had a net book value of approximately
$3.6 million. The
36
Laxdale acquisition gave rise to the recognition of a further
intangible fixed asset, representing intellectual property
rights, relating to Miraxion (formerly known as Lax-101) and
other intellectual property valued at $6.9 million. At the
time of the Laxdale acquisition the useful economic life
remaining for the November 2000 intangible fixed asset and the
intangible acquired on purchase of Laxdale was determined as
15.5 years, representing the time to patent expiry.
Foreign
exchange
Amarin holds cash in pounds sterling, US dollars and Euro. In
2005, continuing operations incurred a loss of $0.8 million
arising from holding pounds sterling as the US dollar
strengthened. Offsetting this loss was a $0.9 million gain
arising on the translation into US dollars of the operating
results of our research and development subsidiary, Laxdale,
whose functional currency is pounds sterling.
Discontinued
Operations
There were no discontinued activities in 2005. For the year
ended December 31, 2004, the Company earned an operating
loss of $1.2 million on discontinued activities. The
operating loss from discontinued activities for 2004 reflects:
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the results of Amarins former U.S. operations that
were sold to Valeant in February 2004 as described above;
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the research and development costs incurred by Amarin in 2004
relating to the completion of safety studies on Zelapar (the
rights to which are owned by Valeant). Following the sale of the
majority of Amarins U.S. operations to Valeant in the
first quarter of 2004, Amarin remained responsible for the cost
undertaking safety studies on Zelapar and was liable for up to
$2.5 million of development costs. That obligation has been
fulfilled and Amarin will not incur any more costs relating to
the development of Zelapar; and
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the settlement of an outstanding dispute with Valeant. In
September 2004, Amarin reached agreement with Valeant to settle
a dispute following the disposal of our US operations and
certain product rights. It was agreed that a $3 million
payment (which was contingent upon completion of the Zelapar
safety studies) would be reduced to $2 million and paid to
Amarin, unconditionally on November 30, 2004 of which
$1 million was paid to Elan. Amarin also agreed to waive
rights to future milestone payments from Valeant of $3,000,000
(due on successful completion of Zelapar safety studies) and
$5,000,000 (due on approval by the US Food and Drug
Administration).
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In addition, three exceptional items relating to discontinued
activities arose in 2004 as follows:
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an exceptional loss of $3.1 million on disposal of the
majority of the U.S. operations and certain products to
Valeant;
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an exceptional gain of $0.75 million, representing receipt
of the final installments of the sale proceeds from the disposal
of Amarins Swedish drug delivery business to Watson in
October 2003; and
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an exceptional gain of $24.6 million on the settlement of
debt obligations to Elan.
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Revenue
Discontinued Revenues in 2004 were $1.0 million arising
from API being included from January 1 to February 25 2004,
being the date of its disposal. In 2004, all of our revenue was
attributable to discontinued operations.
Gross
Margin
The gross margin for 2004 from discontinued business was a
profit of $0.9 million from revenues derived from API for
the period January 1 to February 25 2004, its disposal date. The
Company is now focused on research and development and has
divested itself of all its revenue generating products.
37
Operating
Expenses
In 2004, expenses for discontinued operations included selling,
general and administrative expenses of $1.6 million which
were costs that originated at API prior to its divesture,
research and development expenses of $2.5 million
representing our obligations to fund Zelapar safety studies
as part of the disposal of API to Valeant, and $2 million
of other income associated with the settlement of our dispute
with Valeant. The $2.5 million in 2004 reflects the costs
incurred by Amarin on Zelapar as explained above.
Amortization
Amortization of Permax and the Primary Care Portfolio is
included in selling, general and administrative expenses.
Amortization expenditure was $nil in 2004, as both Permax and
the Primary Care Portfolio were impaired down to their net
realized values, at 31 December 2003, using the disposal
proceeds values arising from the 25 February 2004 disposal
to Valeant.
Interest
and Similar Income and Interest and Similar
Expense
Net interest expense for 2005 was $0.5 million compared to
net interest income of $0.22 million for 2004. The
2005 net income comprises interest and similar income of
$0.4 million compared to $0.55 million in 2004 which
was earned from cash balances held on deposit and on the loan
made to Laxdale prior to its acquisition, and interest expense
and similar charges of $0.89 million compared to
$0.33 million in 2004. The interest expense arises on the
loan from Elan (which was subsequently assigned to
Mr. Thomas Lynch), as explained in more detail below in
Liquidity and Capital Resources. Net
interest expense is a loss in 2005 of $0.5 million
primarily due to holding cash balances in Sterling. A
significant portion of our expenditure is denominated in
Sterling and we thus hold some cash in Sterling to meet the cash
flow requirements. However the dollar strengthened against
Sterling in the year, leaving a book loss of $0.8 million.
Taxation
A non-cash deferred tax accounting charge of $7.5 million
on the exceptional gain on the settlement of debt obligations to
Elan is included in the tax charge for the year ended
December 31, 2004. This offsets a deferred tax credit of an
equivalent amount included in the income statement of the fourth
quarter of 2003.
Preference
Share Dividend
During 2003, the last remaining 2,000,000 3% convertible
preference shares held by Elan were converted into 2,000,000
ordinary shares and non-equity dividends of $24,000 were
accrued. On conversion, Elan gave up their preferential rights,
including rights to an accrued dividend, in exchange for the new
ordinary shares allocated. In February 2004, Amarin settled its
debt obligations with Elan by the payment of cash and the issue
of a $5 million loan note. As a result, with there being no
longer a need to maintain an accrual for a preference dividend
in 2004, Amarin released the accrued preference share dividends
of $643,000.
Comparison
of Fiscal Years Ended December 31, 2004 and
December 31, 2003
Overview
In 2004, we saw significant change to the business with the sale
of our US sales and marketing operations, the settlement of
outstanding debt obligations and the acquisition of Laxdale, our
former research partner. In addition, a private placement of
equity was competed raising $12.775 million. In 2003 we saw
strong competition to Permax, our leading product at the time,
from both other dopamine agonists and generic competition that
entered the market in December 2002. In addition, as disclosed
in our annual report on
Form 20-F
for the year ended December 31, 2002, we ended 2002 with
high wholesaler inventory levels for all of our US products and
experienced low revenues during 2003 as in-market inventory
levels at the end of 2003 declined. These factors resulted in
significant losses in 2003 and significant net cash outflow.
This deterioration in our trading during 2003 meant that we were
unable to generate sufficient cash flows from operations to meet
our debt obligations. To address our debt obligations we
divested most of our operations through
38
two transactions, one in 2003 and the other shortly after the
year-end. The first of these transactions was the sale of Amarin
Development AB (ADAB) on October 28,
2003. The second was the sale of API on February 25, 2004.
In accordance with UK GAAP, the results of both businesses
divested were shown as discontinued for 2004 and for the
comparative years ended December 31, 2003 and 2002.
Continuing
Operations
Revenue
After the disposals of ADAB and API, our remaining business
comprised a corporate head office and US rights to Miraxion for
Huntingtons disease, which was then owned by Laxdale
Limited. Accordingly, our continuing operations did not generate
any revenues in 2004 or 2003.
Operating
Expenses
Total operating expenses for the continuing business were
$9.9 million in 2004 compared to $6.2 million in 2003,
an increase of 60%, and comprised selling, general and
administrative expenses of $7,456,000 in 2004 ($5,624,000 in
2003), research and development expenses of $981,000 in 2004
(nil in 2003), a once-off non-recurring payment of $891,000 in
2004 (nil in 2003) and amortization of product rights of
$599,000 in 2004 ($576,000 in 2003).
Interest
Income and Interest Expense
Net interest expense for 2003 was $0.8 million compared to
$2.0 million for 2002. The 2003 net charge comprises
Interest Income of $0.1 million (compared to
$0.4 million in 2002), which was entirely earned from cash
balances held on deposit, and Interest Expense of
$0.9 million (compared to $2.4 million in 2002). The
Interest Expense for 2003 arose on the $25 million interest
bearing loan from Elan. The 2002 comparative included a
provision of $0.5 million for interest on a capital gains
tax liability in relation to the disposal of assets in a
discontinued business in 1999. The reduction in Net Interest
Expense is primarily due to lower average interest bearing debt
during 2003 compared to 2002 following the January 2003
$17.5 million partial loan repayment to Elan.
Discontinued
Operations
Revenue
As explained above, discontinued operations include the results
of API up to February 25, 2004 and of ADAB for the period
through to its sale on October 28, 2003.
Discontinued Revenues in 2004 were $1.0 million compared
with $7.4 million for 2003, a decline of $6.4 million
or 86%.
Revenues for 2004 were impacted by a number of factors in
addition to underlying trading changes. The key factors were the
inclusion of API through February 25, 2004 compared to the
full year 2003.
For 2003, Permax net revenues were negative $2.4 million
because of the return charges caused by the return of unsold
products by wholesalers, and net revenues prior to these charges
were $6.6 million. This compares to $41.3 million of
Permax revenues in 2002. At the end of 2002, wholesale customers
held significant inventories of Permax and with the decline in
demand due to competition did not require us to make further
sales throughout 2003. In-market inventory levels at the end of
2003 remained high in number of months forward coverage
due to the reduction in monthly in-market demand.
In 2003, the primary care product portfolio and the Phrenilin
family of products generated revenue of $5.0 million and
$2.1 million respectively.
In-market total Permax prescriptions fell to 68,815 in the year
to December 31, 2003 from 160,469 in the prior year, a
decline of 57%. Consistent with the trend seen in 2002,
according to external industry data, total prescriptions for the
dopamine agonist market in which Permax competes continued to
grow and were up 14%
39
to 1.6 million in the year to December 31, 2003. We
attribute the decline in prescriptions of Permax to greater
sales and marketing resources dedicated to competing dopamine
agonists, the introduction of a competitive generic product and
labeling safety disadvantages of Permax. At the end of 2003,
based on an externally sourced report, wholesalers and similar
customers held approximately 7.1 months supply at the
end of 2003 (based on December 2003 in-market demand) compared
to 5.1 months (based on December 2002 in-market demand) at
the end of 2002. Externally sourced inventory information is not
readily available and when available is not necessarily accurate
or verifiable.
In 2003, 54% of our revenue was attributable to one customer,
and the next four largest customers accounted for an additional
36% of our revenue.
The gross margin for 2004 from discontinued business was a
profit of $0.9 million compared to a loss of
$4.5 million for 2003. The 2004 profit was a result of the
operation of the US
business API up to the date of
its disposal, February 25, 2004. The 2003 loss was a result
of the charges against revenue explained above plus the charges
for inventory provisions of $5.3 million relating to Permax
and Primary Care in-house inventory that was projected to expire
prior to its sale, offsetting these charges are
$0.6 million reduction in Permax royalty payments relating
to the exceptional reductions in revenues.
Operating
Expenses
Included in the 2004 selling, general and administrative
expenses attributable to discontinued operations were research
and development expenses incurred by Amarin on behalf of Valeant
of $2.5 million, income of $2 million on settling the
outstanding dispute with Valeant and the results of the US
business up to the date of disposal, February 25, 2004.
Included in the 2003 selling, general and administrative
expenses attributable to discontinued operations were impairment
charges of $10.1 million relating to the write down of the
intangible assets of Permax ($9.4 million) and the primary
care portfolio ($0.7 million). The 2003 impairment charges
were made to reflect the actual net realizable value under the
Valeant sale post year-end.
Included in total operating expenses for 2003 was
$0.1 million in royalties and distribution fees to Elan for
sales of Permax.
As of January 1, 2003 we changed our functional currency
from pounds sterling to US dollars, which eliminated the effect
of foreign exchange rates on US dollar amounts from that date
forward. Our foreign currency net investments were not hedged by
currency borrowings or other hedging instruments.
A gain of $13.1 million arose on the sale of ADAB to Watson
in 2003 and was disclosed in disposal of operations and was
attributable to discontinued operations.
Taxation
In 2003, a deferred tax asset of $7.5 million was
recognized on the excess of tax book values compared to
accounting carrying values for Permax. A deferred tax asset on
part of the timing differences was recognized to the extent that
it was realized in 2004 to shelter a gain arising on the
settlement of Elan debt obligations. Establishing this deferred
tax asset gave rise to a tax credit of $7.5 million in
2003, being the substantial portion of the 2003 tax credit of
$7.4 million. Included in the 2002 tax on profit on
ordinary activities of $3.5 million is a provision of
$2.6 million in relation to corporate tax on a capital gain
incurred on the disposal of assets in a discontinued business
which took place during the 1999 fiscal year.
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. As discussed above we disposed of ADAB in
October 2003 and certain product lines and API in February 2004.
This facilitated the settlement of our debt obligations owed to
Elan. Following our acquisition of Laxdale, the Company is now a
neuroscience company focused on the research, development and
commercialization of novel drugs for central nervous system
disorders. As such, our key asset is our research and
development pipeline and the related intellectual property
portfolio, which is classified under intangible assets. Our main
source of funds until such time as the products under
development receive regulatory approval for marketing
40
will be from equity based financings and license fees (upfront
and milestone fees) from partnering our drug development
pipeline. As such we consider our most critical accounting
policies to be those relating to intangible assets and
specifically the treatment of research and development
expenditure, together with our accounting policy relating to
revenue recognition and specifically the treatment of upfront
fees and milestones. Both critical accounting policies are
considered customary within research and development companies
in the pharmaceuticals industry.
Intangible
Assets
Under UK GAAP intangible fixed assets are recognized when they
meet the definitions set out in accounting standards. FRS 7
Fair values in acquisition accounting refers to
separability (where items can be disposed of separately from the
company as a whole) and control (e.g. via custody or
legal/contractual rights). FRS 10 Goodwill and intangible
assets refers to reliable measurement. We have applied
these standards to the acquisition of Amarin Neuroscience
Limited (see note 3 to this
Form 20-F
annual report) such that the value of the intangible fixed asset
recognized, as supported by risk adjusted discounted cashflow
analysis, is capped to ensure negative goodwill does not arise.
UK GAAP requires that we periodically evaluate acquired assets
for potential impairment indicators. Our judgments regarding the
existence of impairment indicators are based on legal factors,
market conditions, operational performance and expected cash
flows from the assets. Since indications of impairments can
result from events outside of our control, it can be difficult
to predict when an impairment loss may occur. However, should an
impairment occur, we would be required to write down the
carrying value of the affected asset to its recoverable amount
and to recognize a corresponding charge to the income statement.
Any such impairment may have a material adverse impact on our
financial condition and results of operations.
When we acquire a development product, as required under UK
GAAP, amounts paid are capitalized and amortized over the
estimated life of that asset. If the intangible asset is a
marketed product, the amount capitalized is reviewed for
impairment by comparing the net present value of future cash
flows to the carrying value of the asset.
Under U.S GAAP long-lived assets chiefly relate to amounts
capitalized in connection with acquired intangible assets. These
assets are amortized over their estimated useful lives, which
generally range from ten to fifteen years. Management
periodically reviews the appropriateness of the remaining useful
lives of its long-lived assets in the context of current and
expected future market conditions. In the event that we are
required to reduce our estimate of the useful lives of any of
our long-lived assets, it would shorten the period over which we
amortize the affected asset and may result in a material
increase of amortization expense prospectively from the date of
the change in estimate.
Overview
of UK and US GAAP difference
Under UK GAAP pharmaceutical products which are in the clinical
trials phase of development can be capitalized and amortized
where there is a sufficient likelihood of future economic
benefit. Under US GAAP specific guidance relating to
pharmaceutical products in the development phase requires such
amounts to be expensed unless they have attained certain
regulatory milestones.
Revenue
Recognition
Prior to the sale of our US business in February 2004 we derived
the majority of our revenues from the sale of pharmaceutical
products. Under UK GAAP, we recognized revenue for the invoiced
value of products delivered to the customer, less applicable
discounts. Our normal sales terms allowed for product returns
under certain conditions. We accrued for estimated sales returns
and allowances and offset these amounts against revenue. We
regularly reviewed our estimates against actual returns and also
factored in other variables such as planned product
discontinuances and market and regulatory considerations. Actual
returns and deductions were processed against returns and
deductions reserves and such reserves were updated to reflect
differences between estimates and actual experience.
41
Under UK GAAP income under license agreements is recognized when
amounts have been earned through the achievement of specific
milestones set forth in those agreements
and/or the
costs to attain those milestones have been incurred by us.
Under US GAAP and in accordance with Staff Accounting
Bulletin 101 Revenue Recognition in Financial
Statements, as updated by Staff Accounting
Bulletin 104 Revenue Recognition and Emerging
Issues Task Force or EITF00-21 Revenue Arrangements with
Multiple Deliverables, revenue from licensing agreements
would be recognized based upon the performance requirements of
the agreement. Non-refundable fees where the company has an
ongoing involvement or performance obligation would be recorded
as deferred revenue in the balance sheet and amortized into
license fees in the profit and loss account over the estimated
term of the performance obligation.
Overview
of UK and US GAAP difference
Under UK GAAP milestone payments have been recognized when
achieved. Under US GAAP, the Companys adoption of
SAB 101 (which has now been updated by
SAB 104) resulted in the deferral of revenue
associated with certain up-front payments and refundable
milestone payments. This deferred revenue is then released to
the income statement systematically over time.
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.
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 US shareholders.
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B.
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Liquidity
and Capital Resources
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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 securities. At
December 31, 2005 we had approximately $33.9 million
in cash representing an increase of $22.9 million from
December 31, 2004. Based upon management forecasts, we have
sufficient cash to fund our operations into the fourth quarter
of 2007.
Over the three years ended December 31, 2005, we have
received $69.5 million in cash from the issuance of shares
(net of expenses) and $11.9 million in loans, the loans
having been provided by Elan, a related party until October
2004. We have made loan repayments of $35.7 million during
this three-year period. These repayments related to loans
received during the three years ended December 31, 2004 and
in earlier periods. During 2004, we settled and re-financed the
Companys remaining debt. At December 31, 2004 we had
approximately $11.0 million in cash and $2.0 million
in debt with a cash maturity in 2009; this was redeemed for
equity simultaneous with the May 2005 registered offering.
Cash
As of December 31, 2005, we had approximately
$33.9 million in cash compared with $11.0 million as
of December 31, 2004. This cash has been invested primarily
in US dollar and sterling pound denominated money market and
checking accounts with financial institutions in the UK having a
high credit standing.
Cash flows expended on continuing operations were
$18.1 million for the year ended December 31, 2005 as
compared with $11.1 million for the year ended
December 31, 2004 and $5.0 million for the year ended
December 31, 2003. Cash flows generated on discontinued
operations were $1.0 million for the year ended
December 31, 2004 as compared with cash flows expended on
these discontinued activities of $10.1 million for the year
ended December 31, 2003.
42
The operating cash flows expended on continuing and discontinued
operations reflect funding of the operating loss of
$18.9 million adjusted for non-cash depreciation and
amortization ($0.8 million), and no net movement in working
capital. In 2004, the operating cash flows expended on
continuing and discontinued operations reflect funding of the
operating loss of $11.1 million adjusted for non-cash
depreciation and amortization ($0.8 million), and a net
inflow on working capital of $0.2 million.
Cash flows expended on investing activities were
$0.1 million in 2005 as compared to $28.5 million
generated in 2004. Our investing activities related to the
purchase of fixed assets. Our principal investing activities in
2004 related to the acquisition of Zelapar $7.9 million
outflow and subsequent disposal to Valeant as part of API, as
described above. The intangible assets included within the API
disposal generated cashflows of $36.4 million. Our
principal investing activities in 2003 related to the purchase
of the remaining US rights to Permax from Elan for which
$16.1 million was paid in 2003 and $10.9 million in
2002.
In 2005, cash of $1.3 million was expended on the
professional fees and other costs associated with the
financings. In 2004, cash of $0.8 million was expended on
the professional fees and other costs associated with the
acquisition of Amarin Neuroscience Limited, together with the
assumption of $2.7 million in overdrafts and loans
$1.8 million of cash was eliminated from the Company upon
the disposal of API. Cash of $1.6 million was received for
the disposal of shares in API offset by cash outflows of
$11.8 million associated with the API disposal. Such
outflows included $9.3 million in inventory management
fees, legal and transaction fees of $2.3 million and
$0.2 million in rental payments in respect of the premises
formerly occupied by API in Mill Valley, California. In 2004,
cash of $0.8 million was received relating to the remaining
escrow proceeds of the 2003 disposal of ADAB.
In 2003 $13.4 million (net of expenses) was received from
the sale of Amarin Development AB and the purchaser additionally
assumed a $0.3 million overdraft.
Cash inflows from financing activity in 2005 were
$41.2 million compared to cash inflows from financing
activities in 2004 and 2003 of $5.5 million and
$1.4 million respectively. Net cash provided by financing
activities in 2005 comprised two financings yielding
$42.5 million offset by issuance costs of
$1.3 million. Net cash provided by financings in 2004
comprised a private placement of ordinary shares
($12.775 million) offset by issuance costs of $953,000.
The 2002 purchase of the remaining US rights to Permax consisted
of a non-cash movement due to the negotiation of a series of
deferred payments, which were in the amount of
$27.5 million. In January 2003, Elan agreed to waive
$7.5 million of the deferred payments and during 2003
$16.1 million was paid, $5 million in two quarterly
installments and $11.1 million from the proceeds received
on the sale of ADAB (see commentary above). As of
December 31, 2003, $3.9 million in deferred payments
was outstanding.
As described in Item 4 Information on the
Company History and Development of the
Company, in December 2005, Amarin entered into definitive
purchase agreements for a private equity placement, consisting
of ordinary shares and warrants, resulting in gross proceeds of
$26.4 million. In accordance with the terms of the
financing, Amarin sold approximately 26.1 million ordinary
shares at $1.01 per share and issued warrants to purchase
approximately 9.1 million ADSs at an exercise price of
$1.43 per share. The net proceeds of this private placement
(taking into account professional advisers fees associated
with filing the related registration agreement, cash fees of our
placement agent and government stamp duty but not our travel,
printing or other expenses) were approximately
$23.9 million.
As described in Item 4 Information on the
Company History and Development of the
Company, we accepted subscriptions of $17.8 million
from institutional and other accredited investors, including
certain directors and executive officers of Amarin, for
13.7 million American Depository Shares in a registered
direct offering at a purchase price of $1.30 per share. The
net proceeds of our May registered offering (taking into account
professional advisers fees associated with filing the
related registration agreement, cash fees of our placement agent
and government stamp duty but not our travel, printing or other
expenses) were approximately $16.5 million. On closing of
this transaction, AIHL redeemed the remaining $2 million in
principal amount of its 8% loan notes issued by Amarin and used
the proceeds of the redemption together with a further $250,000
to subscribe for shares in this offering.
43
As described in Item 4 Information on the
Company History and Development of the
Company, we completed a private placement of 13,474,945
Ordinary Shares, raising gross proceeds of approximately
$12.775 million in October 2004. The net proceeds of our
October 2004 private placement (taking into account professional
advisors fees associated with filing the related
registration agreement with the SEC, cash fees of our placement
agent and government stamp duty but not our travel, printing or
other expenses) were approximately $11.8 million.
As described in Item 4 Information on the
Company History and Development of the
Company, we completed a private placement of 6,093,728
Ordinary Shares, raising gross proceeds of approximately
$21.2 million in January 2003. As part of the private
placement, we issued warrants to acquire 313,234 Ordinary Shares
at an exercise price of $3.4785 per share, which warrants
are exercisable between January 27, 2004 and
January 26, 2008. The net proceeds of our January 2003
private placement (taking into account the cash fees of our
placement agent but not our legal, travel, printing or other
expenses) were approximately $19.1 million. We applied a
portion of these net proceeds, together with available cash
reserves, to satisfy certain payment obligations to Elan. See
Contractual Obligations, Item 7
Major Shareholders and Related Party
Transactions Related Party Transactions
and our financial statements beginning at
page F-1
of this annual report.
At December 31, 2005 Amarin had no debt. At
December 31, 2004, Amarin had total debt of
$2.0 million with a cash maturity in 2009. This is reduced
from debt of $35.4 million due on demand at
December 31, 2003. The $35.4 million of debt was
settled in the first quarter as referred to above, following the
sale of Amarins U.S. operations in the first quarter
of 2004. On September 29, 2004, Amarin Investment
Holding Limited (AIHL) an entity controlled by
Amarins non-executive chairman, Mr. Thomas Lynch,
signed an agreement with Elan to acquire its remaining debt and
equity interests in Amarin, including the remaining
$5 million of loan notes owed by Amarin to Elan. On
October 7, AIHL agreed to redeem $3 million of the
$5 million of loan notes for 2,717,391 ordinary shares with
an option to redeem the remaining $2 million at the
offering price of any future equity financing. In May 2005, AIHL
exercised this option in full.
All treasury activity is managed by the corporate finance group.
Cash balances are invested in short-term money market deposits,
either dollar or sterling. No formal hedging activities are
undertaken although cash balances are maintained in currencies
that match our financial obligations and forecast cashflows.
At December 31, 2005 and 2004 we had cash balances of
$33.9 million and $11.0 million respectively. We
intend to fund our operating expenses from existing cash
balances including the cost of the ongoing phase III trials
for Miraxion in Huntingtons disease. We forecast having
sufficient cash to fund operations into the fourth quarter of
2007. These forward-looking statements involve risks and
uncertainties, and actual results could vary.
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C.
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Research
and Development
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Following the acquisition of Laxdale Limited on October 8,
2004, Amarin has an in-house research and development capability
and expertise, supplemented by retained external consultants.
Prior to their disposals, as discussed above, Amarin undertook
research and development activities through ADAB and API. 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, 2005, are disclosed above. Specifically, we
incurred $8.3 million in 2005. In 2004, we incurred costs
of $2.5 million (2003: $5.4 million) representing
expenses related to API and ADAB. Following the acquisition of
Laxdale our expenditure will be increasingly focused on
proprietary research and development, as we pursue our goal of
becoming a leader in the research, development and
commercialization of novel drugs for CNS disorders. In addition,
we commenced two phase III trials with Miraxion in
Huntingtons disease in late 2005 and have engaged external
clinical research organizations and consultants to assist us, as
detailed below in part F. This will result in our research
and development expenditure increasing significantly in 2006
when compared to the levels incurred in prior years.
Under US GAAP, in 2004, Amarin incurred an in process research
and development charge of $48,235,000 representing the write off
of the Miraxion intangible asset that arises on the acquisition
of Laxdale (See our financial pages beginning on
page F-1,
Note 42, 2J).
44
The acquisition of Laxdale provided Amarin with three
significant in-process R&D projects:
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The full rights to Miraxion for Huntingtons Disease
(HD) in the United States over and above the rights
as licensee in the United States already possessed by Amarin
prior to the acquisition. As noted above in Item 4A
History and Development of the Company Laxdale
Acquisition, prior to the acquisition, Amarin had an
exclusive licence from Laxdale for the US rights to Miraxion for
HD, subject to a 40-45% royalty payable by Amarin to Laxdale
(i.e., the acquisition eliminated a 40-45% royalty on US
sales of Miraxion for HD previously payable by Amarin to
Laxdale);
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The rights to Miraxion for HD in the European Union; and
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The rights to Miraxion for depression in the European Union and
the United States.
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Miraxion, at the time of the acquisition, had completed a
Phase II trial and an initial Phase III trial for HD.
The post hoc data analysis from the initial Phase III trial
had illustrated a statistically significant benefit in a
significant subset of HD patients. This subset of HD patients
represents 65-70% of all HD sufferers. No product has ever been
approved for HD in the United States. Final, large
Phase III trials need to be designed and completed prior to
submitting a New Drug Application (an NDA) to the
FDA for review. There is no certainty that final Phase III
trials will be successful in showing a statistically significant
benefit in treating HD. Without successful trials, Miraxion will
not be approved in the United States or the European Union.
Miraxion had also completed several Phase IIa trials in
treatment-unresponsive depression. Approximately one-third of
patients treated with standard depression therapy see no benefit
and a further one-third see an initial benefit that wears off.
In a number of Phase IIa trials, Miraxion provided benefit
to these treatment-unresponsive patients. Before
Miraxion can be approved for treating depression, further
phase II studies and final Phase III studies must be
completed. There is no certainty that such studies will be
successfully completed.
In 2004, we changed our business model; therefore any trend
analysis would be meaningless. We refer users to Items 4.B
Business Overview, 5.A Operating Results
and 5.B Liquidity and Capital Resources.
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E.
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Off
Balance Sheet Transactions
|
Although there are no disclosable off balance sheet
transactions, there have been transactions involving contingent
milestones see
Note 40 Related Party
Transactions in the financial statements.
|
|
F.
|
Contractual
Obligations
|
The following table summarizes our payment obligations as of
December 31, 2005. The operating lease obligations
primarily represent rent payable on properties leased by the
Company. Some of the properties leased by the Company have been
sub-let and generate rental income.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period in
$000s
|
|
|
|
|
|
|
Less than
|
|
|
1-2
|
|
|
2-3
|
|
|
3-4
|
|
|
4-5
|
|
|
|
|
|
|
Total
|
|
|
1 Year
|
|
|
Years
|
|
|
Years
|
|
|
Years
|
|
|
Years
|
|
|
Thereafter
|
|
|
Long term debt
|
|
|
25
|
|
|
|
11
|
|
|
|
14
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital/finance lease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating lease
|
|
|
4,008
|
|
|
|
840
|
|
|
|
596
|
|
|
|
596
|
|
|
|
596
|
|
|
|
408
|
|
|
|
972
|
|
Purchase obligations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other long term creditors
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
4,033
|
|
|
|
851
|
|
|
|
610
|
|
|
|
596
|
|
|
|
596
|
|
|
|
408
|
|
|
|
972
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During 2005, Amarin Corporation plc has opened an office in
Dublin; the amount payable for the one year lease is $71,000.
45
There are no capital commitments relating to the Miraxion
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 6% on future sales of Miraxion
(consisting of 5% payable to Scarista Limited and 0.5% payable
to each of Dr. Malcolm Peet and Dr. Krishna Vaddadi).
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. Such contingent consideration may become
payable upon marketing approval being obtained for approval of
products (covered by Laxdales intellectual property) by
the FDA and EMEA. The first approval obtained in the US and
Europe would result in additional consideration of
£7,500,000 payable, for each approval, to the selling
shareholders of Laxdale Limited in either cash or stock (at the
sole option of each of the selling shareholders). The second
approval obtained in the US and Europe would result in
additional consideration of £5,000,000 payable, for each
approval, to the vendors of Laxdale Limited. (See note 33
to our financial statements beginning on
page F-1
of this annual report).
During 2005, Amarin engaged various clinical research
organizations and consultants to assist in the design, project
management and roll-out of the ongoing two phase III trials
with Miraxion in Huntingtons disease. We entered into a
clinical trial agreement with the University of Rochester on
March 18, 2005. Pursuant to this agreement the University
is obliged to carry out or to facilitate the carrying out of a
clinical trial research study set forth in a research protocol
on Miraxion in patients with Huntingtons disease in the
U.S. Additionally, we appointed Icon, plc, a clinical research
organization to carry out a similar study in the European Union.
The cost associated with the clinical trial agreements with the
University of Rochester and Icon are estimated as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated Payments Due by Period
in $000s from 1 January 2006
|
|
|
|
|
|
|
Less than
|
|
|
1-2
|
|
|
2-3
|
|
|
3-4
|
|
|
4-5
|
|
|
|
|
|
|
Total
|
|
|
1 Year
|
|
|
Years
|
|
|
Years
|
|
|
Years
|
|
|
Years
|
|
|
Thereafter
|
|
|
Clinical research
|
|
|
9,314
|
|
|
|
7,054
|
|
|
|
2,260
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Item 6
|
Directors,
Senior Management and Employees
|
|
|
A.
|
Directors
and Senior Management
|
The following table sets forth certain information regarding our
officers and directors. A summary of the background and
experience of each of these individuals follows the table.
|
|
|
|
|
|
|
Name
|
|
Age
|
|
Position
|
|
Thomas Lynch
|
|
|
49
|
|
|
Chairman and Non-Executive Director
|
Richard Stewart
|
|
|
47
|
|
|
Chief Executive Officer and
Director
|
Alan Cooke
|
|
|
35
|
|
|
Chief Financial Officer and
Director
|
John Groom
|
|
|
67
|
|
|
Non-Executive Director
|
Anthony Russell-Roberts
|
|
|
60
|
|
|
Non-Executive Director
|
Dr. William Mason
|
|
|
54
|
|
|
Non-Executive Director
|
Dr. Simon Kukes
|
|
|
49
|
|
|
Non-Executive Director
|
Dr. Michael Walsh
|
|
|
54
|
|
|
Non-Executive Director
|
Dr. Prem Lachman
|
|
|
45
|
|
|
Non-Executive Director
|
Dr. John Climax
|
|
|
53
|
|
|
Non-Executive Director
|
Tom Maher
|
|
|
39
|
|
|
General Counsel and Company
Secretary
|
Darren Cunningham
|
|
|
33
|
|
|
Executive Vice President,
Strategic Development
|
Dr. Mehar Manku
|
|
|
57
|
|
|
Vice President,
Research & Development
|
Dr. Tony Clarke
|
|
|
50
|
|
|
Vice President, Clinical
Development
|
Mr. Thomas Lynch joined us on January 21, 2000 as
Chairman and Non-Executive Director. Mr. Lynch previously
worked at Elan Corporation plc. While there, he had a number of
roles including Vice Chairman, Executive Vice President, Chief
Financial Officer and Director. Prior thereto, Mr. Lynch
was a partner in the
46
international accounting firm of KPMG, where he specialized in
the provision of international corporate financial services.
Mr. Lynch is also a director of IDA Ireland (an Irish
governmental agency), Icon plc , Neuronyx Inc, Tripep AB and is
a trustee of the Royal Opera House, Covent Garden, London.
Mr. Richard Stewart joined us in November 1998 as our
President and Chief Operating Officer and became Chief Executive
Officer in 2000. Prior to joining us, Mr. Stewart was
responsible for corporate strategy as Corporate Development
Director of SkyePharma plc, having previously been their Finance
Director. He holds a B.Sc. in business administration from the
University of Bath, School of Management. Mr. Stewart
joined our board of directors on November 23, 1998.
Mr. Alan Cooke was appointed as Chief Financial Officer and
executive director in May 2004. Prior to joining Amarin,
Mr. Cooke spent approximately eight years at Elan
Corporation, plc, most recently as Vice President, Global
Strategic Planning. Prior to Elan, Mr. Cooke worked at
KPMG, Dublin for 4 years. He holds a Bachelor of Commerce
degree and a Diploma in Professional Accounting from University
College, Dublin. Mr. Cooke is a fellow of the Institute of
Chartered Accountants (Ireland).
Mr. John Groom joined us as a Non-Executive Director on
May 29, 2001. Mr. Groom served as President and Chief
Operating Officer of Elan Corporation plc from July 1996 until
his retirement in January 2001. Mr. Groom was President,
Chief Executive Officer and Director of Athena Neurosciences,
Inc. prior to its acquisition by Elan in 1996. Mr. Groom
serves on the board of directors of Ligand Pharmaceuticals,
Neuronyx Inc. and CV Therapeutics Europe Ltd.
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. 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 started
as a general management trainee with Watney Mann, which was
followed by 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 as a Non-Executive Director
on July 19, 2002. Dr. Mason is an entrepreneur with a
strong scientific background in healthcare and life sciences. He
received his doctorate in physiology from Trinity College,
Cambridge in 1977. For twenty years Dr. Mason led a public
and industry-funded program of neuroscience-focused medical
research using cellular and molecular genetics, advanced
computing and engineering technology for the visualization of
chemical events in biological cells and high throughput drug
discovery. During this time, Dr. Mason also played an
active part as a member of the Advisory Council on Science and
Technology in the UK Cabinet Office of HM Government focused on
changes to the educational system to effect the development of a
more highly qualified scientific and technical manpower base in
the UK. He also founded several successful high technology
companies. Currently, Dr. Mason is Chairman of Cytomyx plc
(AIM: CYX), Camlab Ltd., Ranier Technology Ltd and Team
Consulting Ltd, a board director of Sage Healthcare Ltd and
Sphere Medical Ltd., and an Advisory Board Member of Cambridge
Gateway Fund. He is also a member of the 3i Independent
Directors Program.
Dr. Simon Kukes was appointed a director on January 1,
2005. Dr. Kukes is an American citizen. Dr. Kukes is
the CEO at Samaru Nulta, a Russian oil company, partnering with
Amerada Hess, a U.S. based international oil company. He
was President and Chief Executive of Tyumen Oil Company (TNK)
from 1998 until its merger with British Petroleum (BP) in 2003.
He then joined Yukos Oil as chairman. He also served as chief
executive of Yukos from 2003 until June 2004. In 1999, he was
voted one of the Top 10 Central European Executives by the Wall
Street Journal Europe and in 2003 he was named by The Financial
Times and PricewaterhouseCoopers as one of the 64 most respected
business leaders in the world. He owns approximately 8% of the
ordinary shares of Amarin. Dr. Kukes has a primary degree
in Chemical Engineering from the Institute for Chemical
Technology, Moscow and a PhD in Physical Chemistry from the
Academy of Sciences, Moscow and was a Post-Doctoral Fellow of
Rice University, Houston, Texas. He is the holder of more than
130 patents and has published more than 60 scientific papers. He
is currently a member of the Council of Energy, Marine
Transportation and Public Policy at Columbia University in New
York.
47
Dr. Michael Walsh was appointed a director on
January 1, 2005. Dr. Walsh is an executive director of
International Investment and Underwriting (IIU), a
private equity firm based in Dublin. Dr. Walsh is Chairman
of Irish Nationwide Building Society, one of Irelands main
mortgage providers. He is a non-executive director of a number
of companies including London City Airport, Daon, a company
involved in biometric authentication and Seer Partners, a
technology oriented venture capital company. Dr. Walsh has
Bachelor of Commerce and Master of Business Studies degrees from
University College Dublin and MBA and PhD degrees from the
Wharton School, University of Pennsylvania. Prior to IIU,
he was an executive director of NCB Group Ltd, one of
Irelands leading stockbrokers. He was previously Professor
of Banking and Finance at University College Dublin.
Dr. Prem Lachman was appointed a director on August 4,
2005. Dr. Lachman is a founder and general partner of
Maximus Capital, $100 million healthcare investment
management company focused on investments in the biotechnology
and pharmaceutical industries. Dr. Lachman was formerly a
general partner at the Galleon Group from 1998 until 2001 and
prior to that was a managing director in the Investment Research
Department at Goldman Sachs & Co. Dr. Lachman
received his M.D. degree from the Mount Sinai School of Medicine
in May 1986.
Dr. John Climax was appointed a non-executive director of
Amarin on March 20, 2006. Dr. Climax was a
founder of ICON Clinical Research 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.
Mr. Tom Maher was appointed General Counsel and Company
Secretary in February 2006. 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 Director and
later, 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. Darren Cunningham was appointed as our Executive Vice
President Strategic Development in September 2002. Prior to
joining Amarin, Mr. Cunningham worked for Elan Corporation, plc
as manager and then Associate Director of Strategic Planning.
Mr. Cunningham is a member of the Institute of Chartered
Accountants (Ireland) and trained at Price Waterhouse in Dublin.
Dr. Mehar Manku joined us in October 2004 on the
acquisition of Laxdale Limited. He joined Laxdale Limited in May
2001. Prior to this, Dr. Manku was the first Director of
Scotia Research Institute in Kentville, Nova Scotia, a research
facility focusing on the research of fatty acids in health and
disease. Recently, Dr. Manku was appointed Honorary
Professor at the University of Hull, U.K. Dr. Manku is
Editor-in-Chief
and one of the founding Executive Editors of
Prostaglandin, Leukotrienes and Essential Fatty
Acids a well respected, peer review journal in the field
of EFA research. He is author of nearly 250 scientific and
technical papers.
Dr. Anthony Clarke joined us in August 2005 as Vice
President, Clinical Development. Prior to joining Amarin
Dr. Clarke held senior international positions in Clinical
Research and Regulatory Affairs with SmithKline Beecham,
Cardinal Health and Cephalon. He holds a PhD in
psychopharmacology, has published extensively in the fields of
neuroscience, neurology and psychiatry and is also named as an
inventor on several international patents.
There is no family relationship between any director or
executive officer and any other director or executive officer.
General
Our directors who serve as officers or employees receive no
compensation for their service as members of our board of
directors. Directors who are not officers or employees receive
£25,000 ($45,000) per annum save for the Chairmen of the
Audit and Remuneration Committees who receive £40,000
($72,000) and such options to acquire Ordinary Shares for their
service as non-executive members of the board of directors as
the Remuneration
48
Committee of the board of directors may from time to time
determine. Thomas Lynch has to date waived all of his rights
with respect to option grants to non-executive directors that
were proposed during his tenure as a director.
For the year ended December 31, 2005, all of our directors
and senior management as a group received total compensation of
U.S $2,514,000 and in addition, directors and senior management
were issued options to purchase a total of 825,000 Ordinary
Shares during such period. See Share
Ownership below for the specific terms of the options held
by each director and officer.
There are no sums set aside or accrued by us for pension,
retirement or similar benefits although we do make contributions
to certain of our employees and officers pensions
during the term of their employment with us.
Compensation paid and benefits granted to our directors during
the year ended December 31, 2005 are detailed below:
Directors
detailed emoluments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Salary
|
|
|
Benefits
|
|
|
Annual
|
|
|
2005
|
|
Name
|
|
& fees
|
|
|
in kind
|
|
|
bonus
|
|
|
Total
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Thomas Lynch (Chairman)
|
|
|
250
|
|
|
|
|
|
|
|
|
|
|
|
250
|
|
Richard Stewart (Chief Executive
Officer)*
|
|
|
520
|
|
|
|
9
|
|
|
|
301
|
|
|
|
830
|
|
Alan Cooke (Chief Financial
Officer)*
|
|
|
269
|
|
|
|
8
|
|
|
|
129
|
|
|
|
406
|
|
John Groom
|
|
|
45
|
|
|
|
|
|
|
|
|
|
|
|
45
|
|
Anthony Russell-Roberts
|
|
|
72
|
|
|
|
|
|
|
|
|
|
|
|
72
|
|
Dr. William Mason
|
|
|
72
|
|
|
|
|
|
|
|
|
|
|
|
72
|
|
Dr. Simon Kukes
|
|
|
45
|
|
|
|
|
|
|
|
|
|
|
|
45
|
|
Dr. Michael Walsh
|
|
|
45
|
|
|
|
|
|
|
|
|
|
|
|
45
|
|
Dr. Prem Lachman
|
|
|
19
|
|
|
|
|
|
|
|
|
|
|
|
19
|
|
Hubert Huckel (resigned
February 28, 2005)
|
|
|
11
|
|
|
|
|
|
|
|
|
|
|
|
11
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,348
|
|
|
|
17
|
|
|
|
430
|
|
|
|
1,795
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Benefits in kind include medical and life insurance for each
executive director. No expense allowances were provided to the
directors during the year.
|
|
|
* |
|
In addition to the above, Mr. Stewart and Mr. Cooke
have pension contributions paid into their personal scheme or
accrued by the Company in 2005 of $33,000 and $103,000
respectively. The payment, which is in excess of
Mr. Stewarts and Mr. Cookes normal
entitlement under the Companys pension scheme
arrangements, was approved by the Remuneration Committee. |
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 eight million Ordinary Shares
may be issued under the plan. 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 US Internal Revenue
49
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.
The plan provides that the vesting of options shall be
accelerated if we undergo a change of control and at the
discretion of the remuneration committee. In the event of an
offer to acquire all of our issued share capital or the
acquisition of all of our issued share capital in other
specified circumstances, the option holder may release its
option in return for the grant of a new option over shares in
the acquiring company.
If a participants 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 participants 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 participants name has been delivered to
the participant.
The plan is governed by the laws of England.
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.
We presently have ten 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.
At the annual general meeting for 2005, Messrs. Kukes,
Walsh, Cooke, Groom and Stewart, retired by rotation, and were
re-elected. Assuming no further directors choose to retire and
not stand for re-election at the annual general meetings in 2006
and 2007, we would expect Messrs. Lachman, Mason,
Russell-Roberts and Lynch to retire and stand for re-election at
the 2006 annual general meeting and Messrs. Cooke, Stewart
and Kukes to retire and stand for re-election at the 2007 annual
general meeting. See Directors and Senior
Management above for details of when each of our directors
joined our board of directors.
50
Audit
Committee
The audit committee of the board of directors comprises 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.
The audit committee currently comprises the following directors:
|
|
|
|
|
Dr. William Mason (Chairman);
|
|
|
|
Dr. Simon Kukes; and
|
|
|
|
Mr. John Groom (Financial Expert)
|
Remuneration
Committee
The remuneration committee of the board of directors comprises
three of our non-executive directors. The remuneration
committees 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.
The remuneration committee currently comprises the following
directors:
|
|
|
|
|
Mr. Anthony Russell-Roberts (Chairman);
|
|
|
|
Dr. Michael Walsh; and
|
|
|
|
Dr. Prem Lachman.
|
The average numbers of employees employed by us during each of
the past three financial years are detailed below:
|
|
|
|
|
|
|
|
|
|
|
|
|
Employment Activity
|
|
12/31/05
|
|
|
12/31/04
|
|
|
12/31/03
|
|
|
Marketing and Administration
|
|
|
12
|
|
|
|
15
|
|
|
|
50
|
|
Research and Development
|
|
|
11
|
|
|
|
3
|
|
|
|
25
|
|
Computing
|
|
|
|
|
|
|
|
|
|
|
2
|
|
Laboratory
|
|
|
|
|
|
|
|
|
|
|
13
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
23
|
|
|
|
18
|
|
|
|
90
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
Number of
|
|
|
Number of
|
|
|
|
Employees
|
|
|
Employees
|
|
|
Employees
|
|
Country
|
|
12/31/05
|
|
|
12/31/04
|
|
|
12/31/03
|
|
|
UK
|
|
|
18
|
|
|
|
11
|
|
|
|
8
|
|
Ireland
|
|
|
5
|
|
|
|
|
|
|
|
|
|
US
|
|
|
|
|
|
|
7
|
|
|
|
33
|
|
Sweden
|
|
|
|
|
|
|
|
|
|
|
49
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
23
|
|
|
|
18
|
|
|
|
90
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
51
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
2005 are presented in the table below. See also
Compensation the Amarin
Corporation plc 2002 Stock Option Plan.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options/Warrants
|
|
|
|
|
|
|
|
|
Ordinary
|
|
|
|
|
|
|
|
|
|
Outstanding
|
|
|
|
|
|
|
|
|
Shares or
|
|
|
|
|
|
|
|
|
|
to Acquire
|
|
|
|
|
|
Exercise
|
|
|
ADS
|
|
|
|
|
|
|
|
|
|
Number of
|
|
|
|
|
|
Price per
|
|
|
Equivalents
|
|
|
Percentage
|
|
|
|
|
|
|
Ordinary
|
|
|
Date of Grant
|
|
|
Ordinary
|
|
|
Beneficially
|
|
|
of Outstanding
|
|
Director/Officer
|
|
Note
|
|
|
Shares
|
|
|
(dd/mm/yy)
|
|
|
Share
|
|
|
Owned
|
|
|
Share Capital*
|
|
|
J. Groom
|
|
|
1
|
|
|
|
15,000
|
|
|
|
23/01/02
|
|
|
$
|
17.65
|
|
|
|
404,349
|
|
|
|
|
|
|
|
|
1
|
|
|
|
15,000
|
|
|
|
06/11/02
|
|
|
$
|
3.10
|
|
|
|
|
|
|
|
|
|
|
|
|
1
|
|
|
|
25,000
|
|
|
|
21/07/04
|
|
|
$
|
0.84
|
|
|
|
|
|
|
|
|
|
|
|
|
7
|
|
|
|
55,099
|
|
|
|
21/12/05
|
|
|
$
|
1.43
|
|
|
|
|
|
|
|
|
|
|
|
|
1
|
|
|
|
20,000
|
|
|
|
11/01/06
|
|
|
$
|
1.35
|
|
|
|
|
|
|
|
|
|
T. G. Lynch
|
|
|
2
|
|
|
|
500,000
|
|
|
|
25/02/2004
|
|
|
$
|
1.90
|
|
|
|
9,696,038
|
|
|
|
10.5
|
%
|
|
|
|
8
|
|
|
|
207,921
|
|
|
|
21/12/05
|
|
|
$
|
1.43
|
|
|
|
|
|
|
|
|
|
W. Mason
|
|
|
1
|
|
|
|
15,000
|
|
|
|
06/11/02
|
|
|
$
|
3.10
|
|
|
|
|
|
|
|
|
|
|
|
|
1&3
|
|
|
|
25,000
|
|
|
|
21/07/04
|
|
|
$
|
0.84
|
|
|
|
|
|
|
|
|
|
|
|
|
1&3
|
|
|
|
20,000
|
|
|
|
11/01/06
|
|
|
$
|
1.35
|
|
|
|
|
|
|
|
|
|
A. Russell-Roberts
|
|
|
4
|
|
|
|
10,000
|
|
|
|
07/04/00
|
|
|
$
|
3.00
|
|
|
|
2,350
|
|
|
|
|
|
|
|
|
4
|
|
|
|
10,000
|
|
|
|
19/02/01
|
|
|
$
|
6.12
|
|
|
|
|
|
|
|
|
|
|
|
|
1
|
|
|
|
15,000
|
|
|
|
23/01/02
|
|
|
$
|
17.65
|
|
|
|
|
|
|
|
|
|
|
|
|
1
|
|
|
|
15,000
|
|
|
|
06/11/02
|
|
|
$
|
3.10
|
|
|
|
|
|
|
|
|
|
|
|
|
1
|
|
|
|
25,000
|
|
|
|
21/07/04
|
|
|
$
|
0.84
|
|
|
|
|
|
|
|
|
|
|
|
|
1
|
|
|
|
20,000
|
|
|
|
11/01/06
|
|
|
$
|
1.35
|
|
|
|
|
|
|
|
|
|
R. A. B. Stewart
|
|
|
5
|
|
|
|
350,000
|
|
|
|
23/11/98
|
|
|
$
|
5.00
|
|
|
|
53,983
|
|
|
|
|
|
|
|
|
1
|
|
|
|
150,000
|
|
|
|
23/01/02
|
|
|
$
|
17.65
|
|
|
|
|
|
|
|
|
|
|
|
|
1
|
|
|
|
150,000
|
|
|
|
06/11/02
|
|
|
$
|
3.10
|
|
|
|
|
|
|
|
|
|
|
|
|
6
|
|
|
|
300,000
|
|
|
|
10/06/05
|
|
|
$
|
1.30
|
|
|
|
|
|
|
|
|
|
|
|
|
7
|
|
|
|
8,663
|
|
|
|
21/12/05
|
|
|
$
|
1.43
|
|
|
|
|
|
|
|
|
|
|
|
|
1
|
|
|
|
300,000
|
|
|
|
16/01/06
|
|
|
$
|
1.95
|
|
|
|
|
|
|
|
|
|
S. Kukes
|
|
|
7
|
|
|
|
519,802
|
|
|
|
21/12/05
|
|
|
$
|
1.43
|
|
|
|
6,997,685
|
|
|
|
7.6
|
%
|
|
|
|
1
|
|
|
|
20,000
|
|
|
|
11/01/06
|
|
|
$
|
1.35
|
|
|
|
|
|
|
|
|
|
M. Walsh
|
|
|
7
|
|
|
|
38,119
|
|
|
|
21/12/05
|
|
|
$
|
1.43
|
|
|
|
214,507
|
|
|
|
|
|
|
|
|
1
|
|
|
|
20,000
|
|
|
|
11/01/06
|
|
|
$
|
1.35
|
|
|
|
|
|
|
|
|
|
A. Cooke
|
|
|
1
|
|
|
|
375,000
|
|
|
|
07/07/04
|
|
|
$
|
0.85
|
|
|
|
250,133
|
|
|
|
|
|
|
|
|
6
|
|
|
|
200,000
|
|
|
|
10/06/05
|
|
|
$
|
1.30
|
|
|
|
|
|
|
|
|
|
|
|
|
7
|
|
|
|
15,594
|
|
|
|
21/12/05
|
|
|
$
|
1.43
|
|
|
|
|
|
|
|
|
|
|
|
|
1
|
|
|
|
200,000
|
|
|
|
16/01/06
|
|
|
$
|
1.95
|
|
|
|
|
|
|
|
|
|
P. Lachman
|
|
|
1
|
|
|
|
20,000
|
|
|
|
11/01/06
|
|
|
$
|
1.35
|
|
|
|
|
|
|
|
|
|
J. Climax
|
|
|
9
|
|
|
|
226,980
|
|
|
|
21/12/05
|
|
|
$
|
1.43
|
|
|
|
6,312,961
|
|
|
|
|
|
D. Cunningham
|
|
|
1
|
|
|
|
60,000
|
|
|
|
18/07/02
|
|
|
$
|
3.46
|
|
|
|
15,000
|
|
|
|
|
|
|
|
|
1
|
|
|
|
40,000
|
|
|
|
24/02/03
|
|
|
$
|
3.17
|
|
|
|
|
|
|
|
|
|
|
|
|
1
|
|
|
|
75,000
|
|
|
|
21/07/04
|
|
|
$
|
0.84
|
|
|
|
|
|
|
|
|
|
|
|
|
1
|
|
|
|
100,000
|
|
|
|
12/01/06
|
|
|
$
|
1.53
|
|
|
|
|
|
|
|
|
|
T. Maher
|
|
|
1
|
|
|
|
325,000
|
|
|
|
2/12/05
|
|
|
$
|
1.16
|
|
|
|
19,802
|
|
|
|
|
|
|
|
|
7
|
|
|
|
6,931
|
|
|
|
21/12/05
|
|
|
$
|
1.43
|
|
|
|
|
|
|
|
|
|
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 500,000
Ordinary Shares, on or before |
52
|
|
|
|
|
February 25, 2009. Amarin Investment Holding Limited
is an entity controlled by our Chairman, 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) |
|
When granted 100,000 of these options were to become exercisable
at an exercise price of $25.00 in tranches upon the price of our
Ordinary Shares achieving certain pre-determined levels. On
February 9, 2000, our remuneration committee approved the
re-pricing of these 100,000 options to an exercise price of
US$5.00 per Ordinary Share, exercisable immediately and the
Company entered into an amendment agreement on the same day
amending the exercise price from $25.00 to $5.00 and removing
the performance criteria attached to such options. These options
are currently exercisable and remain exercisable until
1st April 2009. |
|
(6) |
|
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. |
|
(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. |
|
(8) |
|
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, Mr. Thomas Lynch |
|
(9) |
|
5,664,446 of 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. |
* This information is based on 78,924,735 Ordinary Shares
outstanding as of March 29, 2006.
|
|
Item 7
|
Major
Shareholders and Related Party Transactions
|
The following table sets forth to the best of our knowledge
certain information regarding the ownership of our Ordinary
Shares at December 31, 2005 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.
|
|
|
|
|
|
|
|
|
|
|
Number of
|
|
|
Percentage of
|
|
|
|
Ordinary Shares
|
|
|
Outstanding
|
|
|
|
or ADS Equivalents
|
|
|
Share
|
|
Name of Owner(1)
|
|
Beneficially Owned
|
|
|
Capital(2)
|
|
|
Southpoint(3)
|
|
|
10,697,830
|
|
|
|
11.6
|
%
|
Amarin Investment Holding
Limited(4)
|
|
|
10,403,959
|
|
|
|
11.3
|
%
|
Simon G. Kukes(5)
|
|
|
7,517,487
|
|
|
|
8.2
|
%
|
Sunninghill Limited(6)
|
|
|
6,539,941
|
|
|
|
7.1
|
%
|
Notes:
|
|
|
(1) |
|
Unless otherwise noted, the persons referred to above have sole
investment power. |
|
(2) |
|
This information is based on 77,548,908 Ordinary Shares
outstanding, 9,948,268 warrants granted over Ordinary Shares and
4,574,164 share options granted over Ordinary Shares as of
December 31, 2005. |
|
(3) |
|
This information is based on the following holdings: |
|
|
|
|
|
|
|
|
|
Name of Fund
|
|
Ordinary Shares
|
|
|
Warrants*
|
|
|
Southpoint Fund LP
|
|
|
787,848
|
|
|
|
252,515
|
|
Southpoint Qualified Fund LP
|
|
|
3,409,315
|
|
|
|
1,092,227
|
|
Southpoint Offshore Operating
Fund LP
|
|
|
3,901,657
|
|
|
|
1,254,268
|
|
Warrants are exercisable after 180 days from
December 21, 2005.
53
|
|
|
(4) |
|
Includes warrants to purchase 500,000 Ordinary Shares, which
warrants are exercisable on or before February 25, 2009 and
warrants to purchase 207,921 Ordinary Shares, which warrants are
exercisable after 180 days from December 21, 2005.
Amarin Investment Holding Limited is an entity controlled by our
Chairman, Mr. Thomas Lynch., |
|
(5) |
|
Includes warrants to purchase 519,802 Ordinary Shares, which
warrants are exercisable after 180 days from
December 21, 2005. |
|
(6) |
|
Includes warrants to purchase 226,980 Ordinary Shares, which
warrants are exercisable after 180 days from
December 21, 2005. 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 Company held
by major shareholders, either directly or by virtue of ownership
of ADSs
|
|
|
|
|
|
|
|
|
|
|
|
|
Name of Owner(1)
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
Southpoint
|
|
|
11.1
|
|
|
|
|
|
|
|
|
|
Amarin Investment Holding Limited
|
|
|
11.0
|
|
|
|
20.8
|
|
|
|
|
|
Simon G. Kukes
|
|
|
8.2
|
|
|
|
7.9
|
|
|
|
6.0
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|
Sunninghill Limited
|
|
|
7.1
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|
|
|
13.9
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|
|
|
|
|
Belsay Limited
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|
|
|
|
|
|
6.8
|
|
|
|
|
|
Essex Woodlands Health Venture
Fund V, LP
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|
|
|
|
|
|
8.5
|
|
|
|
9.4
|
|
Elan Corporation plc and its
subsidiaries
|
|
|
|
|
|
|
|
|
|
|
24.0
|
|
Horizon Waves & Co. as
nominee for the Smith Barney Fundamental Value Fund
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|
|
|
|
|
|
|
|
8.3
|
|
None of the above shareholders has voting rights that differ
from those of our other shareholders. The total number of ADSs
outstanding as of March 24, 2006 was approximately
51.5 million. The ADSs represented approximately 65% of the
issued and outstanding Ordinary Shares as of such date. As at
March 24, 2006, to the best of our knowledge, we estimate
that US shareholders constituted approximately 20% of the
beneficial holders of both our Ordinary Shares and our ADSs.
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B.
|
Related
Party Transactions
|
During the year ended December 31, 2005 we entered into
certain contracts, with related parties. Details of such
transactions are given below.
In May 2005 our audit committee reviewed and approved:
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the issuance of 3,841,537 Ordinary Shares at a subscription
price of $1.30 per Ordinary Share to certain directors and
officers of the Company pursuant to a registered direct offering
of Ordinary Shares on the same terms as those offered to all
such other non related party investors;
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the early redemption of the remaining $2,000,000 principal
amount of 8 per cent secured loan notes of the Company held
by Amarin Investment Holding Ltd (AIHL);
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the proposed capitalization of the proceeds of such redemption
under the term of such offering by the issuance of 1,538,461
Ordinary Shares at a subscription price of $1.30 per
Ordinary Share.
|
In June 2005 our audit committee reviewed and approved the
appointment of Icon as its CRO to manage and oversee its
European phase III study on Miraxion and to monitor and
central laboratory services provider in the Companys US
phase III study on Miraxion. The Company took the view at
this time that the definition of a related party transaction (as
per
Regulation S-K,
Item 404) would include any contract between the
Company and, inter alia, any security holder who was
known to hold 5% or more of the Companys shares where that
person has a direct or indirect material interest in the
contract and that an interest above 10% in the share capital of
a contracting company is likely to amount to a material interest
for NASDAQ purposes. At that time and from the Companys
own, and from the most recent publicly available records,
Sunninghill Limited, a company controlled by Dr John Climax,
held approximately 7% of our entire issued share capital and
Poplar Limited, a company controlled by Dr
54
Climax, held approximately 11% of Icon. On March 20, 2006,
Dr. Climax subsequentially became a non-executive director
of the company.
In December 2005 our audit committee reviewed and approved the
issuance of Ordinary Shares and warrants to certain directors
upon the same terms as those offered to non related party
investors.
In March 2006, our remuneration committee reviewed and approved
a consultancy agreement between the Company and Dalriada Limited
in relation to the provision by Dalriada Limited to the Company
of corporate consultancy services, including consultancy
services relating to financing and other corporate finance
matters, investor and media relations and implementation of
corporate strategy. Under the Consultancy Agreement, the Company
will pay Dalriada Limited a fee of £240,000 per annum for
the provision of the consultancy services. Dalriada Limited is
owned by a family trust, the beneficiaries of which include Mr.
Thomas Lynch and family members.
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C.
|
Interests
of Experts and Counsel
|
Not applicable.
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|
Item 8
|
Financial
Information
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|
|
A.
|
Consolidated
Statements and Other Financial Information
|
See our consolidated financial statements beginning at
page F-1.
Legal
Proceedings
Permax
Litigation
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 is not established, but is consistent with other
fibrotic side effects observed in Permax.
During 2005, five lawsuits alleging claims related to cardiac
valvulopathy and Permax were pending in the United States. Eli
Lilly, Elan, Valeant,
and/or
Amarin were defendants in these lawsuits. As of the present
date, each of these cases has settled. Most of the details of
these settlements are confidential.
One other lawsuit, which alleges claims related to compulsive
gambling and Permax, remains pending in the United States.
Amarin, Eli Lilly, Elan, and Valeant are defendants in this
lawsuit, and are defending against the claims and allegations.
This case is currently in the early stages of discovery. A
similar lawsuit related to compulsive gambling and Permax is
being threatened against Eli Lilly, Elan,
and/or
Valeant, and could possibly implicate Amarin.
The company has reviewed the position and having taken external
legal advice considers 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 2005.
55
Other
We are not a party to any other legal or arbitration proceedings
that may have, or have had in the recent past, significant
effects on our financial position or profitability. No
governmental proceedings are pending or, to our knowledge,
contemplated against us. We are not a party to any material
proceeding in which any director, member of senior management or
affiliate of ours is either a party adverse to us or our
subsidiaries or has a material interest adverse to us or our
subsidiaries.
Policy
on Dividend Distributions
We have never paid dividends on the Ordinary Shares and do not
anticipate paying any cash dividends on the Ordinary Shares in
the foreseeable future. Under English law, any payment of
dividends would be subject to the Companies Act, which requires
that all dividends must be approved by our board of directors
and, in some cases, our shareholders, and may only be paid from
our distributable profits and only to the extent we have
retained earnings, in each case determined on an unconsolidated
basis. See Item 10 Additional
Information Memorandum and Articles of
Association Description of Ordinary
Shares Dividends.
Except as otherwise disclosed in this annual report in regard to
Dr. Prem Lachman joining our Board of Directors on
August 4, 2005 and Dr. Hubert Huckel retiring from our
Board on February 28, 2005, no significant change has
occurred during the calendar year 2005. Dr. John Climax
joined our Board of Directors on March 20, 2006.
56
|
|
Item 9
|
The Offer
and Listing
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|
A.
|
Offer and
Listing Details
|
The following table sets forth the range of high and low closing
sale prices for our ADSs for the periods indicated, as reported
by the Nasdaq Capital Market. These prices do not include retail
mark-ups, markdowns, or commissions but give effect to a change
in the number of Ordinary Shares represented by each ADS,
implemented in both October 1998 and July 2002. Historical data
in the table has been restated to take into account these
changes.
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US$
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US$
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High
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Low
|
|
|
Fiscal Year Ended
|
|
|
|
|
|
|
|
|
December 31, 2001
|
|
|
27.97
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|
|
|
5.00
|
|
December 31, 2002
|
|
|
21.00
|
|
|
|
2.76
|
|
December 31, 2003
|
|
|
4.81
|
|
|
|
1.39
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|
December 31, 2004
|
|
|
3.99
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|
|
|
0.53
|
|
December 31, 2005
|
|
|
3.40
|
|
|
|
1.06
|
|
Fiscal Year Ended
December 31, 2004
|
|
|
|
|
|
|
|
|
First Quarter
|
|
|
3.50
|
|
|
|
1.35
|
|
Second Quarter
|
|
|
1.46
|
|
|
|
0.86
|
|
Third Quarter
|
|
|
0.97
|
|
|
|
0.53
|
|
Fourth Quarter
|
|
|
3.99
|
|
|
|
1.00
|
|
Fiscal Year Ended
December 31, 2005
|
|
|
|
|
|
|
|
|
First Quarter
|
|
|
3.40
|
|
|
|
2.14
|
|
Second Quarter
|
|
|
2.36
|
|
|
|
1.06
|
|
Third Quarter
|
|
|
1.67
|
|
|
|
1.32
|
|
Fourth Quarter
|
|
|
1.45
|
|
|
|
1.07
|
|
Quarter Ended March 31, 2006
|
|
|
|
|
|
|
|
|
September 2005
|
|
|
1.51
|
|
|
|
1.42
|
|
October 2005
|
|
|
1.45
|
|
|
|
1.26
|
|
November 2005
|
|
|
1.26
|
|
|
|
1.10
|
|
December 2005
|
|
|
1.20
|
|
|
|
1.09
|
|
January 2006
|
|
|
3.43
|
|
|
|
1.27
|
|
February 2006
|
|
|
3.74
|
|
|
|
2.96
|
|
On March 29, 2006, the closing price of our ADSs as
reported on the Nasdaq Capital Market was US $3.34 per ADS.
Not applicable.
Our ADSs, which are evidenced by American Depositary Receipts,
are traded on the Nasdaq Capital Market, the principal trading
market for our securities, under the symbol AMRN.
There is no public trading market for our Ordinary Shares. Each
ADS represents one Ordinary Share.
NASD
Rule Election
Pursuant to NASD Rule 4350(a)(1) for Foreign Private
Issuers we have elected to follow the home country practice of
the United Kingdom in lieu of the requirements of NASD Rules
4350(i)(D) and 4350(i)(1)(A). Under NASD 4350(i)(D), issuers are
required to obtain shareholder approval prior to the issuance of
common stock at a
57
price less than the greater of book or market value which
together with sales by officers, directors or substantial
shareholders of the company that equals 20% or more of the
common stock or more of the voting power outstanding. Under NASD
4350(i)(1)(A), issuers are required to obtain shareholder
approval prior to when a stock option or purchase plan is
established or materially amended or other equity compensation
arrangement is made pursuant to which stock may be acquired by
officers, directors, employees or consultants of the issuer,
subject to certain exceptions. No requirements similar to those
described in the preceding two sentences exist under the laws of
England and Wales.
Not applicable.
Not applicable.
Not applicable.
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|
Item 10
|
Additional
Information
|
Not applicable.
|
|
B.
|
Memorandum
and Articles of Association
|
Objects
and Purposes
We were formed as a private limited company under the Companies
Act 1985 and re-registered as a public limited company on
March 19, 1993 under registered number 02353920. Under
article 4 of our memorandum of association, our objects are
to carry on the business of a holding company and to carry on
any other business in connection therewith as determined by the
board of directors.
Directors
Directors
Interests
A director may serve as an officer or director of, or otherwise
have an interest in, any company in which we have an interest. A
director may not vote (or be counted in the quorum) on any
resolution concerning his appointment to any office or any
position from which he may profit, either with us or any other
company in which we have an interest. A director is not
prohibited from entering into transactions with us in which he
has an interest, provided that all material facts regarding the
interest are disclosed to the board of directors.
A director is not entitled to vote (or be counted in the quorum)
on any resolution relating to a transaction in which he has an
interest which he knows is material. However, this prohibition
does not apply to any of the following matters:
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he or any other person receives a security or indemnity in
respect of money lent or obligations incurred by him or any
other person at the request of or for the benefit of us or any
of our subsidiaries;
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|
a security is given to a third party in respect of a debt or
obligation of us or any of our subsidiaries which he has himself
guaranteed or secured in whole or in part;
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|
a contract or arrangement concerning an offer or invitation for
our shares, debentures or other securities or those of any of
our subsidiaries, if he subscribes as a holder of securities or
if he underwrites or sub-underwrites in the offer;
|
58
|
|
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|
a contract or arrangement in which he is interested by virtue of
his interest in our shares, debentures or other securities or by
reason of any interest in or through us;
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|
a contract or arrangement concerning any other company (not
being a company in which he owns 1% or more) in which he is
interested directly or indirectly whether as an officer,
shareholder, creditor or otherwise;
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|
a proposal concerning the adoption, modification or operation of
a pension fund or retirement, death or disability benefits
scheme for both our directors and employees and those of any of
our subsidiaries which does not give him, as a director, any
privilege or advantage not accorded to the employees to whom the
scheme or fund relates;
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|
an arrangement for the benefit of our employees or those of any
of our subsidiaries which does not give him any privilege or
advantage not generally available to the employees to whom the
arrangement relates; and
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|
insurance which we propose to maintain or purchase for the
benefit of directors or for the benefit of persons including
directors.
|
Compensation
of Directors
Each director is to be paid a directors fee at such rate
as may from time to time be determined by the board of directors
and which shall not exceed £500,000 (approximately
USD$890,000 at year end exchange rates) in aggregate to all the
directors per annum. Any director who, at our request, goes or
resides abroad for any purposes or services which in the opinion
of the board of directors go beyond the ordinary duties of a
director, may be paid such extra remuneration (whether by way of
salary, commission, participation in profits or otherwise) as
the board of directors may determine.
Any executive director will receive such remuneration (whether
by way of salary, commission, participation in profits or
otherwise) as the board of directors or, where there is a
committee constituted for the purpose, such committee may
determine, and either in addition to or in lieu of his
remuneration as a director.
Borrowing
Powers of Directors
The board of directors has the authority to exercise all of our
powers to borrow money and issue debt securities. If at any time
our securities should be listed on the Official List of the
London Stock Exchange, our total indebtedness (on a consolidated
basis) would be subject to a limitation of three times the total
of paid up share capital and consolidated reserves.
Retirement
of Directors
At every annual general meeting, one-third of the directors must
retire from office. 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. A director
who has elected to retire is not eligible for re-election. There
is no age limit or requirement that directors retire at a
specified age. However, if a director proposed for election or
re-election has attained the age of 70, this fact must be
disclosed in the notice of the meeting. Directors are not
required to hold our securities.
Description
of Ordinary Shares
Our authorized share capital is £100,000,000 divided into
1,559,144,066 Ordinary Share and 440,855,934 Preference Shares
of 5p each. In the following summary, a shareholder
is the person registered in our register of members as the
holder of the relevant securities. For those Ordinary Shares
that have been deposited in our American Depositary Receipt
facility pursuant to our deposit agreement with Citibank N.A.,
Citibank or its nominee is deemed the shareholder.
59
Dividends
Holders of Ordinary Shares are entitled to receive such
dividends as may be declared by the board of directors. All
dividends are declared and paid according to the amounts paid up
on the shares in respect of which the dividend is paid. To date
there have been no dividends paid to holders of Ordinary Shares.
Any dividend unclaimed after a period of twelve years from the
date of declaration of such dividend shall be forfeited and
shall revert to us. In addition, the payment by the board of
directors of any unclaimed dividend, interest or other sum
payable on or in respect of an Ordinary Share or a Preference
Share into a separate account shall not constitute us as a
trustee in respect thereof.
Rights in
a Liquidation
Holders of Ordinary Shares are entitled to participate in any
distribution of assets upon a liquidation, subject to prior
satisfaction of the claims of creditors and preferential
payments to holders of outstanding Preference Shares.
Voting
Rights
Voting at any general meeting of shareholders is by a show of
hands, unless a poll is demanded. A poll may be demanded by:
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the chairman of the meeting;
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|
at least two shareholders entitled to vote at the meeting;
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|
|
any shareholder or shareholders representing in the aggregate
not less than one-tenth of the total voting rights of all
shareholders entitled to vote at the meeting; or
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|
any shareholder or shareholders holding shares conferring a
right to vote at the meeting on which there have been paid up
sums in the aggregate equal to not less than one-tenth of the
total sum paid up on all the shares conferring that right.
|
In a vote by a show of hands, every shareholder who is present
in person at a general meeting has one vote. In a vote on a
poll, every shareholder who is present in person or by proxy
shall have one vote for every share of which they are registered
as the holder. The quorum for a shareholders meeting is a
minimum of two persons, present in person or by proxy. To the
extent the articles of association provide for a vote by a show
of hands in which each shareholder has one vote, this differs
from US law, under which each shareholder typically is entitled
to one vote per share at all meetings.
Holders of ADSs are also entitled to vote by supplying their
voting instructions to Citibank who will vote the Ordinary
Shares represented by their ADSs in accordance with their
instructions. The ability of Citibank to carry out voting
instructions may be limited by practical and legal limitations,
the terms of our articles and memorandum of association, and the
terms of the Ordinary Shares on deposit. We cannot assure the
holders of our ADSs that they will receive voting materials in
time to enable them to return voting instructions to Citibank a
timely manner.
Unless otherwise required by law or the articles of association,
voting in a general meeting is by ordinary resolution. An
ordinary resolution is approved by a majority vote of the
shareholders present at a meeting at which there is a quorum.
Examples of matters that can be approved by an ordinary
resolution include:
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|
the election of directors;
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|
the approval of financial statements;
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|
the declaration of final dividends;
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|
the appointment of auditors;
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|
the increase of authorized share capital; or
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|
the grant of authority to issue shares.
|
A special resolution or an extraordinary resolution requires the
affirmative vote of not less than three-fourths of the eligible
votes. Examples of matters that must be approved by a special
resolution include modifications to the rights of any class of
shares, certain changes to the memorandum or articles of
association, or our winding-up.
60
Capital
Calls
The board of directors has the authority to make calls upon the
shareholders in respect of any money unpaid on their shares and
each shareholder shall pay to us as required by such notice the
amount called on his shares. If a call remains unpaid after it
has become due and payable, and the fourteen days notice
provided by the board of directors has not been complied with,
any share in respect of which such notice was given, may be
forfeited by a resolution of the board.
Preference
Shares
Currently Amarin has 440,855,934 Preference Shares of 5p each
forming part of its authorized share capital but none of these
preference shares are in issue. Pursuant to an authority given
by the shareholders at the 2005 Annual General Meeting our board
of directors has the authority, without further action by
shareholders, to issue up to 440,855,934 preference shares of 5p
in one or more series and to fix the rights, preferences,
privileges, qualifications and restrictions granted to or
imposed upon the preference shares, including dividend rights,
conversion rights, voting rights, rights and terms of
redemption, and liquidation preference, any or all of which may
be greater than the rights of the ordinary shares. To date, our
board of directors has not issued any such preference shares.
The issuance of preference shares could adversely affect the
voting power of holders of ordinary shares and reduce the
likelihood that ordinary shareholders will receive dividend
payments and payments upon liquidation. The issuance could have
the effect of decreasing the market price of our ordinary
shares. The issuance of preference shares also could have the
effect of delaying, deterring or preventing a change in control
of us.
Our board of directors will fix the rights, preferences,
privileges, qualifications and restrictions of the preference
shares of each series that we sell under this prospectus and
applicable prospectus supplements in the certificate of
designation relating to that series. We will incorporate by
reference into the registration statement of which this
prospectus is a part the form of any certificate of designation
that describes the terms of the series of preference shares we
are offering before the issuance of the related series of
preference shares. This description will include:
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the title and stated value;
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|
the number of shares we are offering;
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|
the liquidation preference per share;
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|
the purchase price per share;
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|
the dividend rate per share, dividend period and payment dates
and method of calculation for dividends;
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|
whether dividends will be cumulative or non-cumulative and, if
cumulative, the date from which dividends will accumulate;
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|
our right, if any, to defer payment of dividends and the maximum
length of any such deferral period;
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|
the procedures for any auction and remarketing, if any;
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|
the provisions for a sinking fund, if any;
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|
the provisions for redemption or repurchase, if applicable, and
any restrictions on our ability to exercise those redemption and
repurchase rights;
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|
any listing of the preference shares on any securities exchange
or market;
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|
whether the preference shares will be convertible into our
ordinary shares or other securities of ours, including warrants,
and, if applicable, the conversion period, the conversion price,
or how it will be calculated, and under what circumstances it
may be adjusted;
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whether the preference shares will be exchangeable into debt
securities, and, if applicable, the exchange period, the
exchange price, or how it will be calculated, and under what
circumstances it may be adjusted;
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|
voting rights, if any, of the preference shares;
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61
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|
preemption rights, if any;
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|
restrictions on transfer, sale or other assignment, if any;
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|
a discussion of any material or special United States federal
income tax considerations applicable to the preference shares;
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the relative ranking and preferences of the preference shares as
to dividend rights and rights if we liquidate, dissolve or wind
up our affairs;
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any limitations on issuances of any class or series of
preference shares ranking senior to or on a parity with the
series of preference shares being issued as to dividend rights
and rights if we liquidate, dissolve or wind up our
affairs; and
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any other specific terms, rights, preferences, privileges,
qualifications or restrictions of the preference shares.
|
If we issue shares of preference shares under this prospectus,
the shares will be fully paid and non-assessable and will not
have, or be subject to, any pre-emptive or similar rights.
Our articles of association and English Law provide that the
holders of preference shares will have the right to vote
separately as a class on any proposal involving changes that
would adversely affect the powers, preferences, or special
rights of holders of that of preference shares.
Pre-emptive
Rights
English law provides that shareholders have pre-emptive rights
to subscribe to any issuances of equity securities that are or
will be paid wholly in cash. These rights may be waived by a
special resolution of the shareholders, either generally or in
specific instances, for a period not exceeding five years. This
differs from US law, under which shareholders generally do not
have pre-emptive rights unless specifically granted in the
certificate of incorporation or otherwise. Pursuant to
resolutions passed at our annual general meeting on
July 25, 2005, our directors are duly authorized during the
period ending on July 25, 2010 to exercise all of our
powers to allot our securities and to make any offer or
agreement which would or might require such securities to be
allotted after that date. The aggregate nominal amount of the
relevant securities that may be allotted under the authority
cannot exceed £75,384,762 (equivalent to 1,507,695,240
Ordinary Shares). Under these resolutions we are empowered to
allot such Ordinary Shares as if English statutory pre-emption
rights did not apply to such issuance and, therefore, without
first offering such Ordinary Shares to our existing shareholders.
Redemption Provisions
Subject to the Companies Act of 1985 and with the sanction of a
special resolution, shares in us may be issued with terms that
provide for mandatory or optional redemption. The terms and
manner of redemption would be provided for by the alteration of
our articles of association.
Subject to the Companies Act of 1985, we may also purchase in
any manner the board of directors considers appropriate any of
our own Ordinary Shares, Preference Shares or any other shares
of any class (including redeemable shares) at any price.
Variation
of Rights
If at any time our share capital is divided into different
classes of shares, the rights of any class may be varied or
abrogated with the written consent of the holders of not less
than 75% of the issued shares of the class, or pursuant to an
extraordinary resolution passed at a separate meeting of the
holders of the shares of that class. At any such separate
meeting the quorum shall be a minimum of two persons holding or
representing by proxy one-third in nominal amount of the issued
shares of the class, unless such separate meeting is adjourned,
in which case the quorum at such adjourned meeting or any
further adjourned meeting shall be one person. Each holder of
shares of that class has one vote per share at such meetings.
62
Meetings
of Shareholders
The board of directors may call general meetings and general
meetings may also be called on the requisition of our
shareholders representing at least one tenth of the voting
rights in general meeting pursuant to section 368 of the
Companies Act 1985. Annual general meetings are convened upon
advance notice of 21 days. Extraordinary general meetings
are convened upon advance notice of 21 days or fourteen
days depending on the nature of the business to be transacted.
Citibank will mail to the holders of ADSs any notice of
shareholders meeting received from us, together with a
statement that holders will be entitled to instruct Citibank to
exercise the voting rights of the Ordinary Shares represented by
ADSs and information explaining how to give such instructions.
Limitations
on Ownership
There are currently no UK foreign exchange controls on the
payment of dividends on our Ordinary Shares or the conduct of
our operations. There are no restrictions under our memorandum
and articles of association or under English law that limit the
right of non-resident or foreign owners to hold or vote our
Ordinary Shares, Preference Shares or ADSs.
Change
of Control
Save as expressly permitted by the Companies Act of 1985, we
shall not give financial assistance, whether directly or
indirectly, for the purposes of the acquisition of any of our
shares or for reducing or discharging any liability incurred for
the purpose of such acquisition.
If an offer is made to acquire more than half of our issued
Ordinary Share capital and such offer has been recommended by
the board, we will use reasonable endeavors to procure that a
like offer is extended to the holders of the Preference Shares
and that such offer remains open for not less than the
acceptance period open to the holders of Ordinary Shares to
enable the holders of Preference Shares to convert any or all of
their Preference Shares and accept the offer if they wish to do
so. There are currently no Preference Shares in issue.
Disclosure
of Interests
Under English Law, any person who acquires an equity interest
above a notifiable percentage must disclose certain
information to us regarding the persons shares. The
applicable threshold is currently 3%. The disclosure requirement
applies to both persons acting alone or, in certain
circumstances, with others. After a persons holdings
exceed the notifiable level, similar notifications
must be made when the ownership percentage figure increases or
decreases by a whole number.
In addition, Section 212 of the Companies Act of 1985 gives
us the authority to require certain disclosure regarding an
equity interest if we know, or have reasonable cause to believe,
that the shareholder is interested or has within the previous
three years been interested in our share capital. Failure to
supply the information required may lead to disenfranchisement
under our articles of association of the relevant shares and a
prohibition on their transfer and on dividend or other payments.
Under the deposit agreement with Citibank pursuant to which the
ADRs have been issued, a failure to provide certain information
pursuant to a similar request may result in the forfeiture by
the holder of the ADRs of rights to direct the voting of the
Ordinary Shares underlying the ADSs and to exercise certain
other rights with respect to the Ordinary Shares. The foregoing
provisions differ from US law, which typically does not impose
disclosure requirements on shareholders.
Directors
Indemnification
Except as hereinafter set forth, there is no provision of the
Companys Memorandum and Articles of Association or any
contract, arrangement or statute under which any director or
officer of the Company is insured or indemnified in any manner
against liability which he may incur in his capacity as such.
63
Article 192 of the Companys Articles of Association
provides:
Subject to and so far as may be permitted by the Acts, every
director or other officer and the Auditors of the Company shall
be indemnified out of the assets of the Company against all
costs, charges, expenses, losses and liabilities which he may
sustain or incur in or about the execution of his office or
otherwise in relation thereto in respect of any liability
incurred by him in defending any proceedings, civil or criminal,
which relate to anything done or omitted or alleged to have been
done or omitted by him as an officer or employee of the Company
and in which judgment is given in his favour, or the proceedings
otherwise disposed of without any finding or admission of any
material breach of duty on his part, or in which he is acquitted
or in connection with any application under any statute for
relief from liability in respect of any such act or omission in
which relief is granted by the Court. Such other indemnities
shall be provided to every Director or other officer as are
appropriate and in accordance with the law.
Traditionally, under section 310 of the Companies Act 1985
(1985 Act), companies cannot exempt directors and auditors from,
or indemnify them against, liability where they are negligent,
in default, or in breach of duty or trust. The reason for this
is that directors owe duties to their company and Parliament has
considered in the past that, in the interests of shareholders,
directors should have to face the consequences of their
derelictions of duty.
This basic prohibition still stands but, as from 6 April
2005 and pursuant to the UK Companies (Audit, Investigations and
Community Enterprise) Act 2004 (the 2004 Act),
companies can take advantage of a specific exemption to
indemnify directors against liabilities to third parties, and
can pay directors costs of defense proceedings as they are
incurred (subject to an obligation to repay if the defense is
not successful). This was to address concerns that directors of
companies with a US listing may face class actions in the US and
to help alleviate (at least in the short term) the cost to
directors of lengthy court proceedings. The key points of the
2004 Act are:
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Companies may indemnify directors against the legal and
financial costs of proceedings brought by third parties. This
does not extend to the legal costs of unsuccessful defense of
criminal proceedings, fines imposed by criminal proceedings and
fines imposed by regulatory bodies;
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Companies may pay directors defense costs as they are
incurred in civil or criminal cases, even if the action is
brought by the company itself. However, a director in this
situation will be required to pay any damages awarded to the
company and to reimburse the company if he fails in his defense
(unless the company has indemnified him in respect of his legal
costs incurred in civil third party proceedings);
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Companies may not provide indemnities to directors of
UK-incorporated associated companies where it would be unlawful
for that indemnity to be provided by the associated company;
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Companies may indemnify officers other than directors;
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Funds provided by the company to a director for these purposes
are permitted under section 330 of the Companies Act 1985;
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Any indemnities provided by a company will need to be disclosed
in the directors report and shareholders will be able to
inspect any indemnification agreement; and
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A decision to indemnify directors under the new rules can be
taken by a Companys board and no shareholder vote is
required by the legislation.
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In addition, companies can obtain liability insurance for
directors and can also pay directors legal costs if they
are successful in defending legal proceedings.
Accordingly, the Companys Board has taken a decision to so
indemnify its Directors and officers and the Company has entered
into forms of indemnity with its Directors and officers which
comply with the 2004 Act. In addition, the Company carries
liability insurance for its directors and officers.
Insofar as indemnification for liabilities arising under the
Securities Act of 1933 may be permitted to directors, officers
and controlling persons of the Company pursuant to the charter
provision, by-law, contract, arrangements, statute or otherwise,
the Company acknowledges that in the opinion of the Securities
and Exchange Commission such indemnification is against public
policy as expressed in the Act and is, therefore, unenforceable.
64
We are party to date, the following material contracts outside
of the ordinary course of business. Copies of these agreements
are filed as exhibits to this annual report.
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Clinical Supply Agreement between Laxdale and Nisshin Flour
Milling Co., Limited dated October 27, 1999 relating to the
supply of ethyl-eicosapentaenoate (ethyl-EPA) by Nisshin to
Laxdale whereby Nisshin are obliged to supply all Laxdales
requirements of ethyl-EPA to Laxdale for clinical supply to be
used in clinical trials.
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License and distribution agreement dated March 26, 2003
between Laxdale and SCIL Biomedicals GMBH providing for a
license to SCIL of the right to market, distribute and sell
products on an exclusive basis in Germany, France, Austria,
Luxembourg, Netherlands and Belgium utilizing our intellectual
property in the pharmaceutical field of Huntingtons
disease and certain smaller indications known as ataxias for a
period of 10 years from the date of agreement or, if later,
until the expiration of patent protection or orphan drug status,
subject to the licensees attainment of specified minimum
sales targets.
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License agreement dated July 21, 2003 between Laxdale and
an undisclosed third party providing for a license to such
undisclosed third party of the right to develop, use, offer to
sell, sell and distribute products on an exclusive basis in
Japan utilizing our intellectual property in the pharmaceutical
fields of Huntingtons disease, depression, schizophrenia,
dementia and certain smaller 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.
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License and distribution agreement dated December 9, 2002
between Laxdale and Juste S.A.Q.F providing for a license to
Juste of the right to market, distribute and sell products on an
exclusive basis in Spain and Portugal utilizing our intellectual
property in the pharmaceutical field of Huntingtons
disease and certain smaller indications known as ataxias for a
period of 10 years from the date of the agreement or, if
later, until the expiration of patent protection or orphan drug
status, subject to the licensees attainment of specified
minimum sales targets.
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License and distribution agreement dated December 12, 2003
between Laxdale and Link Pharmaceuticals Limited providing for a
license to Link of the right to market, distribute and sell
products on an exclusive basis in the United Kingdom and the
Republic of Ireland utilizing our intellectual property in the
pharmaceutical field of Huntingtons disease and certain
smaller indications known as ataxias for a period of
10 years from the date of agreement or, if later, until the
expiration of patent protection or orphan drug status, subject
to the licensees attainment of specified minimum sales
targets.
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Asset Purchase Agreement dated February 11, 2004 with
Valeant Pharmaceuticals International, and Amendment No. 1
thereto dated February 25, 2004, which together provide for
the sale to Valeant of our US subsidiary, Amarin
Pharmaceuticals, Inc., and our rights to Permax, Zelapar and the
primary care portfolio at a purchase price of $38 million
paid at closing and $8 million in contingent milestone
payments. See Item 4A History and
Development of the Company.
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In connection with the Asset Purchase Agreement with Valeant,
Amarin entered into a Development Agreement dated
February 25, 2004 pursuant to which Amarin is responsible
for the implementation of certain clinical studies relating to
Zelapar. Amarin is not required to incur more than an aggregate
of $2.5 million in costs in performing its obligations
under this agreement, and Valeant Pharmaceuticals International
has agreed to pay all costs and expenses incurred by Amarin
thereunder in excess of $2.5 million. The obligation to pay
$2.5 million in costs was fulfilled by Amarin during 2004
and Amarin will not incur any more costs relating to the
development of Zelapar. See
Item 4A History and Development of
the Company.
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Settlement Agreement dated February 25, 2004, with Elan and
certain affiliates thereof, providing for the restructuring of
all of Amarins outstanding obligations to Elan. In
connection with the Settlement Agreement, Amarin issued loan
notes in the aggregate principal amount of $5 million,
bearing interest at 8% per annum with a maturity date of
February 25, 2009. Also in connection with the Settlement
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Agreement, Amarin issued a warrant exercisable for 500,000
Ordinary Shares. See Item 7 Major Shareholders and
Related Party Transactions Related Party
Transactions and
Item 4A History and Development of
the Company.
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Inventory Buy Back Agreement dated March 18, 2004 between
the Company and Swiftwater Group plc, pursuant to which
Swiftwater agreed to assist the Company in effecting the
repurchase of product inventory as required pursuant to the
Asset Purchase Agreement with Valeant Pharmaceuticals
International. Swiftwaters fee for such services is
payable by Valeant.
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Pursuant to this agreement Amarin funded the purchase and
subsequent destruction of $9.3 million in value of product
inventory. Amarin has performed all its obligations under this
agreement.
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Settlement agreement dated September 27, 2004 between the
Company and Valeant Pharmaceuticals International
(Valeant) in respect of the full and final
settlement of a contractual dispute as between Valeant and
Amarin arising out of the purchase by Valeant of API. Pursuant
to this settlement agreement Amarin agreed to forgo part of the
contingent milestones payable by Valeant to Amarin due under the
asset purchase agreement for the API transaction, namely the
entire $5 million contingent milestone payable on FDA
approval of Zelapar and $1 million of the $3 million
contingent milestone previously due when the remaining safety
studies are successfully completed. Also, Valeant has agreed
that Amarin is no longer required to purchase $414,000 of
further inventory from wholesalers and that the remaining
$2 million contingent milestone previously due when the
remaining Zelapar safety studies were successfully completed
would be paid on 30th November 2004 without any such
contingency.
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Form of Subscription Agreement, dated as of October 7, 2004
by and among the Company and the Purchasers named therein. The
Company entered into 14 separate Subscription Agreements on
October 7, 2004 all substantially similar in form and
content to this form of Subscription Agreement and in total
issued 13,474,945 ordinary shares to accredited investors
consisting of new and existing shareholders and management. The
purchase price was $0.947 per share based on the average
closing price of our ADSs on the Nasdaq SmallCap Market for the
ten trading days ended October 6, 2004; however, management
investors paid a purchase price of $1.04 per share based on
the average closing price of our ADSs on the Nasdaq SmallCap
Market for the five trading days ended October 6, 2004.
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Form of Registration Rights Agreement, dated as of
October 7, 2004 between the Company and the Purchasers
named therein. The Company entered into 14 separate Registration
Rights Agreements on October 7, 2004 all substantially
similar in form and content to this form of Registration Rights
Agreement. Pursuant to such Registration Rights Agreements, the
Company agreed to use commercially reasonable efforts to file a
registration statement with respect to the securities purchased
in the offering on
Form F-3
within 60 days of October 7, 2004 and to use
commercially reasonable efforts to cause the registration
statement to be declared effective and to remain effective for a
period ending with the first to occur of (i) the sale of
all securities covered by the registration statement and
(ii) March 30, 2006.
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Share Purchase Agreement dated October 8, 2004 between the
Company, Vida Capital Partners Limited and the Vendors named
therein relating to the entire issued share capital of Laxdale
Limited. The purchase price for the acquisition of Laxdale
comprised an initial consideration of 3.5 million ADSs
representing 3.5 million Ordinary Shares and certain
success based milestone payments payable on a pro rata basis to
the shareholders of Laxdale as follows:
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On receipt of a marketing approval in each of the U.S.
and/or
Europe for the first indication of any product containing
Laxdale intellectual property, Amarin must make a stock or cash
payment (at each of the former Laxdale shareholders sole
option) of GBP£7.5 million for each of such two
potential market approvals (i.e. GBP£15.0 million
maximum); and
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On receipt of a marketing approval in each of the U.S.
and/or
Europe for any other product using Laxdale intellectual property
or for a different indication of a previously approved product,
Amarin must make a stock or cash payment (at each of the former
Laxdale shareholders sole option) of
GBP£5 million for each of such two potential market
approvals (i.e. GBP£10 million maximum).
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See Item 4A History and Development
of the Company for further details.
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Exclusive License Agreement dated October 8, 2004 between
Laxdale and Scarista Limited which provides Laxdale with
re-negotiated rights to specified intellectual property covering
the United States, Canada, the European Union and Japan.
Scarista has granted a license to Laxdale pursuant to which
Laxdale has the exclusive right to use certain of
Scaristas intellectual property (including intellectual
property for the use of Miraxion in drug-resistant depression)
within a field of use encompassing all psychiatric and central
nervous system disorders, and within the territories of the
United States, Canada, the European Union and Japan. As part of
such re-negotiation Scarista is entitled to receive reduced
royalty payments of 5% (reduced from 15%) on all net sales by
Laxdale of products utilizing such Scarista intellectual
property and certain of Laxdales intellectual property
(which intellectual property had been transferred to Laxdale by
Scarista in March, 2000). In consideration of Scarista entering
into this agreement and the reduction of Scaristas royalty
from 15% to 5%, Laxdale has paid a signing fee of £500,000
($891,000) to Scarista. The Scarista intellectual property
licensed to Laxdale is material to our development efforts with
respect to Miraxion. Royalties are payable until the latest to
occur of (i) the expiration of the last patent relating to
any product using the licensed technology, (ii) the
expiration of regulatory exclusivity with respect to any product
using the licensed technology or (iii) the date on which
the licensed technology ceases to be secret and substantial in a
given territory. Upon the termination of royalty payment
obligations with respect to any product, the licensee will
thereafter have a fully paid up, royalty free, non-exclusive
license to continue using the licensed technology in respect of
such product.
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Exclusive License Agreement dated October 8, 2004 between
Laxdale and Scarista Limited whereby Laxdale has granted a
license to Scarista pursuant to which Scarista has the exclusive
right to use certain of Laxdales intellectual property
(including intellectual property for the use of Miraxion in
Huntingtons disease) within a field of use encompassing
all psychiatric and central nervous system disorders, and on a
worldwide basis in all territories other than the United States,
Canada, the European Union and Japan. Laxdale is entitled to
receive royalty payments of 5% on all net sales by Scarista or
its licensees of products utilizing such Laxdale intellectual
property. Royalties are payable until the latest to occur of
(i) the expiration of the last patent relating to any
product using the licensed technology, (ii) the expiration
of regulatory exclusivity with respect to any product using the
licensed technology or (iii) the date on which the licensed
technology ceases to be secret and substantial in a given
territory. Upon the termination of royalty payment obligations
with respect to any product, the licensee will thereafter have a
fully paid up, royalty free, non-exclusive license to continue
using the licensed technology in respect of such product.
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Escrow Agreement dated October 8, 2004 among the Company,
Belsay Limited and Simcocks Trust Limited as escrow agent.
Under the Share Purchase Agreement between the Company, Vida
Partners Limited and the Vendors named therein, the Company has
received warranties from the main selling shareholder of
Laxdale, Belsay Limited, enforceable for a period of
15 months following closing the transaction (the
warranty period). The liability of Belsay Limited under
the warranties is secured by an arrangement whereby the
Sellers Consideration Shares issued by the Company to
Belsay (comprising 75% of the Consideration Shares) are placed
in escrow. The Escrow Agreement permits Belsay to make limited
sales of its shares. See
Item 4A History and Development of
the Company for further details.
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Loan Note Redemption Agreement dated October 14,
2004 between Amarin Investment Holding Limited and the Company.
Pursuant to this agreement $3 million in aggregate
principal amount of the loan notes held by Amarin Investment
Holding Limited (an entity controlled by our Chairman
Mr. Thomas Lynch) were converted into Ordinary Shares at
$1.04 per share and, subject to the review of Amarins
audit committee and approval of Amarins Board of
Directors, and at Amarin Investment Holding Limiteds
option, Amarin Investment Holding Limited may procure that the
remaining $2 million in aggregate principal amount of the
Loan Notes can be converted into Ordinary Shares at the offering
price of any future equity financing. See
Item 4A History and Development of
the Company for further details.
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Clinical Trial Agreement dated March 18, 2005 between
Amarin Neuroscience Limited and the University of Rochester.
Pursuant to this agreement the University is obliged to carry
out or to facilitate the carrying out
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of a clinical trial research study set forth in a research
protocol on Miraxion in patients with Huntingtons disease.
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Loan Note Redemption Agreement dated May, 2005 between
Amarin Investment Holding Limited and the Company. Pursuant to
this agreement $2 million in aggregate principal amount of
the loan notes held by Amarin Investment Holding Limited (an
entity controlled by our Chairman Mr. Thomas Lynch) were
converted into Ordinary Shares at $1.30 per share See
Item 4A History and Development of
the Company for further details.
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Services Agreement dated June 16, 2005 between Icon
Clinical Research Limited and Amarin Neuroscience Limited.
Pursuant to this agreement Amarin Neuroscience Limited appointed
Icon Clinical Research Limited as its clinical research
organization for the European arm of the Phase III clinical
trials relating to the use of Miraxion in Huntingtons
disease.
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Securities Purchase Agreement dated December 16, 2005
between, by and among the Company and the Purchasers named
Therein. The Company entered into 44 separate Securities
Purchase Agreements on December 16, 2005 and in total
issued 26,100,098 ordinary shares to accredited investors and
management. The purchase price was $1.01.
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License Agreement dated December 31, 2005 between Amarin
Neuroscience Limited and Multicell Technologies, Inc. Pursuant
to this agreement Amarin Neuroscience Limited licensed to
Multicell exclusive, worldwide rights of LAX-202 for the
treatment of fatigue in patients suffering from multiple
sclerosis (MS).
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Consultancy Agreement dated March 29, 2006 between Amarin
Corporation plc and Dalriada Limited. Under the Consultancy
Agreement, the Company will pay Dalriada Limited a fee of
£240,000 per annum for the provision of the consultancy
services. Dalriada Limited is owned by a family trust, the
beneficiaries of which include Mr. Thomas Lynch and family
members.
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There are currently no English laws, decrees, regulations or
other legislation that may affect the export or import of
capital, including the availability of cash and cash equivalents
for use by the Company, or that affect the remittance of
dividends, interest or other payments to non-UK resident holders
of Ordinary Shares or ADSs.
UK Tax
Matters
The following statements are intended only as a general guide to
the UK tax consequences of the acquisition, ownership and
disposition of our Ordinary Shares including shares represented
by ADSs evidenced by American Depositary Receipts. This summary
applies to you only if you are a beneficial owner of Ordinary
Shares or ADSs and you are:
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an individual citizen or resident of the US;
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a corporation organized under the laws of the US or any state
thereof or the District of Columbia; or
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otherwise subject to US federal income tax on a net income basis
in respect of the Ordinary Shares or ADSs.
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This summary applies only to holders who will hold our Ordinary
Shares or ADSs as capital assets. This summary is based:
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upon current UK tax law and Revenue and Customs practice and
which may be subject to change, perhaps with retroactive
effect; and
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in part upon representations of Citibank, N.A., as depositary,
and assumes that each obligation provided for in or otherwise
contemplated by the deposit agreement between us and Citibank
and any related agreement will be performed in accordance with
its respective terms.
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The following summary is of a general nature and does not
address all of the tax consequences that may be relevant to you
in light of your particular situation. For example, this summary
does not apply to US expatriates, insurance companies,
investment companies, tax-exempt organizations, financial
institutions, dealers in securities, broker-dealers, investors
that use a
mark-to-market
accounting method, holders who hold ADSs or Ordinary Shares as
part of hedging, straddle or conversion transactions or holders
who own directly, indirectly or by attribution, 10% or more of
the voting power of our issued share capital.
In addition, the following summary of UK tax considerations does
not, except where indicated otherwise, apply to you if:
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you are resident or, in the case of an individual, ordinarily
resident in the UK for UK tax purposes;
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your holding of ADSs or shares is effectively connected with a
permanent establishment in the UK through which you carry on
business activities or, in the case of an individual who
performs independent personal services, with a fixed base
situated therein; or
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you are a corporation which, alone or together with one or more
associated corporations, controls, directly or indirectly, 10%
or more of our issued voting share capital.
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You should consult your own tax advisers as to the particular
tax consequences to you under UK, US federal, state and local
and other foreign laws, of the acquisition, ownership and
disposition of ADSs or Ordinary Shares.
Taxation
of Dividends and Distributions
Under current UK taxation legislation, no tax will be withheld
by us at source from cash dividend payments. A holder of
Ordinary Shares or ADSs should consult his own tax adviser
concerning his tax liabilities on dividends received from us.
UK
Taxation of Capital Gains
You will not ordinarily be liable for UK tax on capital gains
realized on the disposal of Ordinary Shares or ADSs, unless, at
the time of the disposal, you carry on a trade, including a
profession or vocation, in the UK through a branch or agency and
those Ordinary Shares or ADSs are, or have been, held or
acquired for the purposes of that trade or branch or agency.
A holder of Ordinary Shares or ADSs who is an individual and who
has on or after March 17, 1998 ceased to be resident or
ordinarily resident for tax purposes in the UK, but who again
becomes resident or ordinarily resident in the UK within a
period of less than five years and who disposes of Ordinary
Shares or ADSs during that period may also be subject to UK tax
on capital gains, notwithstanding that he is not resident or
ordinarily resident in the UK at the time of the disposal.
Certain disposals of assets (which could include our Ordinary
Shares and ADSs) will give rise to chargeable gains that are to
be included in the computation of the profits of a non-UK
resident company. The provisions will only apply where the
disposal is made while the non-UK resident company is carrying
on a trade in the UK through a permanent
establishment.
UK
Inheritance Tax
Ordinary Shares or ADSs beneficially owned by an individual may
be subject to UK inheritance tax on the death of the individual
or, in some circumstances, if the Ordinary Shares or ADSs are
the subject of a gift, including a transfer at less than full
market value, by that individual (and particular rules apply to
gifts where the donor reserves or retains some benefit).
Inheritance tax is not generally chargeable on gifts to
individuals or on some types of settlement made more than seven
years before the death of the donor. Special rules apply to
close companies and to trustees of settlement who hold Ordinary
Shares or ADSs. Holders of Ordinary Shares or ADSs should
consult an appropriate professional adviser if they make a gift
of any kind or intend to hold any Ordinary Shares or ADSs
through trust arrangements.
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UK Stamp
Duty and Stamp Duty Reserve Tax
UK stamp duty will (subject to specific exceptions) be payable
at the rate of 1.5% (rounded up to the nearest £5) of the
value of shares in registered form on any instrument pursuant to
which shares are transferred:
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to, or to a nominee or agent for, a person whose business is or
includes the provision of clearance services; or
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to, or to a nominee or agent for, a person whose business is or
includes issuing depositary receipts.
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Stamp duty reserve tax, at the rate of 1.5% of the value of the
shares, could also be payable in these circumstances, and on the
issue to such a person, but no stamp duty reserve tax will be
payable if stamp duty equal to that stamp duty reserve tax
liability is paid. In circumstances where stamp duty is not
payable on the transfer of shares in registered form at the rate
of 1.5%, such as where there is no chargeable instrument, stamp
duty reserve tax will be payable to bring the charge up to 1.5%
in total. Stamp duty or stamp duty reserve tax, as the case may
be, will therefore be payable as a result of the issue of ADSs
evidenced by American Depositary Receipts at 1.5% of the value
of the Ordinary Shares underlying the ADSs at the time the
Ordinary Shares are transferred to the depositary bank or its
nominee.
No UK stamp duty will be payable on the acquisition of any ADS
or on any subsequent transfer of an ADS, provided that the
transfer and any subsequent instrument of transfer remains at
all times outside the UK and that the instrument of transfer is
not executed in or brought into the UK and the transfer does not
relate to any matter or thing to be done in the UK. An agreement
to transfer an ADS will not give rise to stamp duty reserve tax.
Subject to some exceptions, a transfer or sale of Ordinary
Shares in registered form will attract ad valorem UK stamp duty
at the rate of 0.5% (rounded up to the nearest £5) of the
dutiable amount, usually the cash consideration for the
transfer. Generally, ad valorem stamp duty applies neither to
gifts nor on a transfer from a nominee to the beneficial owner,
although in cases of transfers where no ad valorem stamp duty
arises, a fixed UK stamp duty of £5 may be payable. Stamp
duty reserve tax at a rate of 0.5% of the amount or value of the
consideration for the transfer may be payable on an
unconditional agreement to transfer shares. If, within six years
of the date of such agreement, an instrument transferring the
shares is executed and stamped, any stamp duty reserve tax paid
may be repaid or, if it has not been paid, the liability to pay
such tax, but not necessarily interest and penalties, would be
cancelled. Stamp duty reserve tax is chargeable whether such
agreement is made or effected in the UK or elsewhere and whether
or not any party is resident or situated in any part of the UK.
The statements in this paragraph headed UK Stamp Duty and
Stamp Duty Reserve Tax summarize the current position and
are intended as a general guide only. Special rules apply to
agreements made by, amongst others, intermediaries, market
makers, brokers, dealers and persons connected with depositary
arrangements and clearance services and certain categories of
person may be liable to stamp duty or stamp duty reserve tax at
higher rates or may, although not primarily liable for the duty
or tax, be required to notify and account for it under the UK
Stamp Duty Reserve Tax Regulations 1996.
Certain
US Federal Income Tax Considerations
Subject to the limitations described below, the following
generally summarizes certain material US federal income tax
consequences to a US Holder (as defined below) of the
acquisition, ownership and disposition of Ordinary Shares. US
Holders of ADSs will be treated for US federal income tax
purposes as owners of the Ordinary Shares underlying the ADSs.
Accordingly, except as noted, the US federal income tax
consequences discussed below apply equally to US Holders of ADSs
and Ordinary Shares. This discussion is limited to US Holders
who are beneficial owners of the Ordinary Shares, and who hold
their Ordinary Shares as capital assets, within the meaning of
the US Internal Revenue Code of 1986, as amended, which we may
refer to as the Code. For purposes of this summary,
a US Holder is a beneficial owner of Ordinary Shares
that does not maintain a permanent establishment or
fixed base in the UK, as such terms are defined in
the double taxation convention between the US and UK and that
is, for US federal income tax purposes,
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a citizen or resident of the US;
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a corporation (or other entity treated as a corporation for US
federal income tax purposes) created or organized in the US or
under the laws of the US or of any state thereof or the District
of Columbia;
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70
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an estate, the income of which is includible in gross income for
US federal income tax purposes regardless of its source; or
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a trust, if a court within the US is able to exercise primary
supervision over the administration of the trust and one or more
US persons have the authority to control all substantial
decisions of the trust.
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If a partnership (including for this purpose any entity treated
as a partnership for US federal income tax purposes) is a
beneficial owner of Ordinary Shares, the treatment of a partner
in the partnership will generally depend upon the status of the
partner and upon the activities of the partnership. Partnerships
and partners in such partnerships should consult their tax
advisers about the US federal income tax consequences of owning
and disposing of Ordinary Shares.
This summary is for general information purposes only. It does
not purport to be a comprehensive description of all of the US
federal income tax considerations that may be relevant to each
US Holders decision in regard to the Ordinary Shares. This
discussion also does not address any aspect of US federal gift
or estate tax, or any state, local or non-US tax laws.
Prospective owners of Ordinary Shares who are US Holders are
advised to consult their own tax advisers with respect to the US
federal, state and local tax consequences, as well as to non-US
tax consequences, of the acquisition, ownership and disposition
of the Ordinary Shares applicable to their particular tax
situations.
This discussion is based on current provisions of the Code,
current and proposed US treasury regulations promulgated
thereunder, the double taxation convention between the US and UK
entered into force on March 31, 2003 and administrative and
judicial decisions, each as of the date hereof, all of which are
subject to change or differing interpretation, possibly on a
retroactive basis. The new convention replaces the double
taxation convention between the US and the UK entered into force
on April 24, 1980. The new convention is effective, in
respect of taxes withheld at source, for amounts paid or
credited on or after May 1, 2003. Other provisions of the
new convention will take effect on certain other dates. A US
Holder would, however, be entitled to elect to have the old
convention apply in its entirety for a period of twelve months
after the effective dates of the new convention. The following
discussion assumes that US holders are residents of the US for
purposes of both the old convention and the new convention and
are entitled to the benefits of these conventions.
This discussion does not address all aspects of US federal
income taxation that may be relevant to a particular US Holder
based on such Holders individual circumstances. In
particular, this discussion does not address the potential
application of the alternative minimum tax nor does it address
the tax treatment of shareholders, partners or beneficiaries of
a holder of Ordinary Shares. In addition, this discussion does
not address the US federal income tax consequences to US Holders
that are subject to special treatment, including broker-dealers,
including dealers in securities or currencies; insurance
companies; taxpayers that have elected
mark-to-market
accounting; tax-exempt organizations; financial institutions or
financial services entities; taxpayers who hold
Ordinary Shares as part of a straddle, hedge or conversion
transaction; US Holders owning directly, indirectly or by
attribution at least 10% of our voting power; taxpayers whose
functional currency is not the US dollar; certain expatriates or
former long-term residents of the US; and taxpayers who acquired
their Ordinary Shares as compensation.
You
should consult your own tax advisers as to the particular tax
consequences to you under UK, US federal, state and local and
other foreign laws, of the acquisition, ownership and
disposition of ADSs or Ordinary Shares.
Taxation
of Dividends
General
Subject to the passive foreign investment company rules
discussed below, the amount of any distributions (including,
provided certain elections are made, as discussed in
UK Withholding Tax/Foreign Tax Credits
below, the full tax credit amount deemed received) paid out of
current
and/or
accumulated earnings and profits, as determined under US tax
principles, will be included in the gross income of a US Holder
on the day such distributions are actually or constructively
received and will be characterized as ordinary income for US
federal income tax purposes. Dividends are subject to taxation
at a reduced rate of 15% provided that the individual has held
the shares for more than 60 days during the
120-day
period beginning 60 days before the ex-dividend date, that
the issuer is a qualified foreign corporation and
that certain other conditions are met. A company is a
qualified
71
foreign corporation if the shares on which the dividend is
paid (or ADRs in respect of such shares) are listed on certain
securities markets including Nasdaq Stock Market, or if the
corporation is eligible for the benefits of a tax treaty
determined to be satisfactory by the US Secretary of the
Treasury. The income tax treaty between the U.S. and the United
Kingdom has been designated as satisfactory for such purpose.
To the extent that a dividend distribution exceeds our current
and accumulated earnings and profits, it will be treated as a
non-taxable return of capital to the extent of a US
Holders adjusted basis in the Ordinary Shares, and
thereafter as capital gain. We do not currently maintain
calculations of our earnings and profits under US tax
principles. Dividends paid by us to corporate US Holders will
not be eligible for the dividends-received deduction that might
otherwise be available if such dividends were paid by a US
corporation.
Foreign
Currency Considerations
Distributions paid by us in pounds sterling will be included in
a US Holders income when the distribution is actually or
constructively received by the US Holder. The amount of the
dividend distribution includible in the income of a US Holder
will be the US dollar value of the pounds sterling, determined
by the spot rate of exchange on the date when the distribution
is actually or constructively received by the US Holder,
regardless of whether the pounds sterling are actually converted
into US dollars at such time. If the pounds sterling received as
a dividend distribution are not converted into US dollars on the
date of receipt, then a US Holder may realize exchange gain or
loss on a subsequent conversion of such pounds sterling into US
dollars. The amount of any gain or loss realized in connection
with a subsequent conversion will be treated as ordinary income
or loss and generally will be treated as US-source income or
loss for foreign tax credit purposes.
UK
Withholding Tax/Foreign Tax Credits
A US Holder that elects to receive benefits under the old
convention is, in principle, entitled to claim a refund from the
Revenue and Customs for (i) the amount of the tax credit
that a UK resident individual would be entitled to receive with
respect to a dividend payment, which we refer to as the
Tax Credit Amount, reduced by (ii) the amount
of UK withholding tax, which we refer to as UK Notional
Withholding Tax, imposed on such dividend payment under
the old convention. The Tax Credit Amount will equal that amount
of UK Notional Withholding Tax imposed on dividends paid by us,
therefore, no such refund is available. However, a US Holder may
be entitled to claim a foreign tax credit for the amount of UK
Notional Withholding Tax associated with a dividend paid by us
by filing a Form 8833 in accordance with US Revenue
Procedure 2000-13. US Holders that file Form 8833 will be
treated as receiving an additional dividend from us equal to the
Tax Credit Amount (unreduced by the UK Notional Withholding
Tax), which additional dividend must be included in the US
Holders gross income, and will be treated as having paid
the applicable UK Notional Withholding Tax due under the old
convention. For purposes of calculating the foreign tax credit,
dividends paid on the Ordinary Shares will be treated as non-US
source income and generally will constitute passive
income or, in the case of certain US Holders,
financial services income. In lieu of claiming a
foreign tax credit, a US Holder may be eligible to claim a
deduction for foreign taxes paid in a taxable year. However, a
deduction generally does not reduce a US Holders US
federal income tax liability on a
dollar-for-dollar
basis like a tax credit.
Under the new convention, the Tax Credit Amount and UK Notional
Withholding Tax described above will no longer apply to US
Holders. The UK does not currently apply a withholding tax on
dividends under its internal tax laws. Were such withholding
imposed in the UK, as permitted under the new convention, the UK
generally will be entitled to impose a withholding tax at a rate
of 15% on dividends paid to US Holders. A US Holder who is
subject to such withholding should be entitled to a credit for
such withholding, subject to applicable limitations, against
such US Holders US federal income tax liability.
The rules relating to foreign tax credits are complex and US
Holders are urged to consult their tax advisers to determine
whether and to what extent a foreign tax credit might be
available in connection with dividends paid on the Ordinary
Shares.
72
Taxation
of the Sale or Exchange of Ordinary Shares; Surrender of ADSs
for Ordinary Shares
Subject to the passive foreign investment rules described below,
a US Holder generally will recognize capital gain or loss on the
sale or exchange of the Ordinary Shares in an amount equal to
the difference between the amount realized in such sale or
exchange and the US Holders adjusted tax basis in such
Shares. Such capital gain or loss will be long-term capital gain
or loss if a US Holder has held the Ordinary Shares for more
than one year and generally will be US-source income for foreign
tax credit purposes. Long-term capital gains realized by an
individual US Holder on a sale or exchange of Ordinary Shares
are generally subject to reduced rates of taxation. The
deductibility of capital losses is subject to limitations.
A US Holder that receives foreign currency upon the sale or
exchange of the Ordinary Shares generally will realize an amount
equal to the US dollar value of the foreign currency on the date
of sale (or, if Ordinary Shares are traded on an established
securities market, in the case of cash basis tax payers and
electing accrual basis taxpayers, the settlement date). A US
Holder will have a tax basis in the foreign currency received
equal to the US dollar amount realized. Any gain or loss
realized by a US Holder on a subsequent conversion or other
disposition of foreign currency will be ordinary income or loss
and will generally be US-source income for foreign tax credit
purposes.
The surrender of ADSs for the underlying Ordinary Shares will
not be a taxable event for US federal income tax purposes and US
Holders will not recognize any gain or loss upon such an
exchange.
PFIC
Rules
Certain adverse US tax consequences apply to a US shareholder in
a company that is classified as a passive foreign investment
company, which is referred to herein as a PFIC. We will be
classified as a PFIC in a particular taxable year if either
(i) 75% or more of our gross income is passive income; or
(ii) the average percentage of the value of our assets that
produce or are held for the production of passive income is at
least 50%. Cash balances, even if held as working capital, are
considered to be passive.
Because we will receive interest income and may receive
royalties, we may be classified as a PFIC under the income test
described above. In addition, as a result of our cash position,
we may be classified as a PFIC under the asset test.
If we were a PFIC in any year during which a US Holder owned
Ordinary Shares, the US Holder would generally be subject to
special rules (regardless of whether we continued to be a PFIC)
with respect to (i) any excess distribution
(generally, distributions received by the US Holder in a taxable
year in excess of 125% of the average annual distributions
received by such Holder in the three preceding taxable years,
or, if shorter, such Holders holding period) and
(ii) any gain realized on the sale or other disposition of
Ordinary Shares. Under these rules:
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the excess distribution or gain would be allocated ratably over
the US Holders holding period;
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the amount allocated to the current taxable year and any taxable
year prior to the first taxable year in which we are a PFIC
would be taxed as ordinary income; and
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the amount allocated to each of the prior taxable years would be
subject to tax at the highest rate of tax in effect for the
taxpayer for that year and an interest charge for the deemed
deferral benefit would be imposed with respect to the resulting
tax attributable to each such prior taxable year.
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US Holders who own ADSs (but not Ordinary Shares) generally
should be able to avoid the interest charge described above by
making a mark to market election with respect to such ADSs,
provided that the ADSs are marketable. The ADSs are
marketable if they are regularly traded on certain US stock
exchanges, or on a foreign stock exchange if:
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the foreign exchange is regulated or supervised by a
governmental authority of the country in which the exchange is
located;
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the foreign exchange has trading volume, listing, financial
disclosure, and other requirements designed to prevent
fraudulent and manipulative acts and practices, remove
impediments to, and perfect the mechanism of, a free and open
market, and to protect investors;
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73
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the laws of the country in which the exchange is located and the
rules of the exchange ensure that these requirements are
actually enforced; and
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the rules of the exchange effectively promote active trading of
listed stocks.
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For purposes of these regulations, the ADSs will be considered
regularly traded during any calendar year during which they are
traded, other than in de minimis quantities, on at least fifteen
days during each calendar quarter. Any trades that have as their
principal purpose meeting this requirement will be disregarded.
If a US Holder makes a
mark-to-market
election, it will be required to include as ordinary income the
excess of the fair market value of such ADSs at year-end over
its basis in those ADSs. In addition, any gain it recognizes
upon the sale of such ADSs will be taxed as ordinary income in
the year of sale. US Holders should consult their tax advisers
regarding the availability of the mark to market election.
A US Holder of an interest in a PFIC can sometimes avoid the
interest charge described above by making a qualified
electing fund or QEF election to be taxed
currently on its share of the PFICs undistributed ordinary
income. Such election must be based on information concerning
the PFICs earnings provided by the relevant PFIC to
investors on an annual basis. We will make such information
available to US Holders upon request, and consequently US
Holders will be able to make a QEF election.
US Holders should consult their tax advisers regarding the US
federal income tax considerations discussed above and the
desirability of making a mark-to market election.
US Backup
Withholding and Information Reporting Requirements
Dividend payments made with respect to the Ordinary Shares, and
proceeds received in connection with the sale or exchange of
Ordinary Shares may be subject to information reporting to the
IRS and backup withholding (currently imposed at a rate of 30%).
Backup withholding will not apply, however, if a US Holder
(i) is a corporation or comes within certain other exempt
categories and, when required, demonstrates such fact or
(ii) provides a taxpayer identification number, certifies
as to no loss of exemption from backup withholding and otherwise
complies with applicable backup withholding rules. Persons
required to establish their exempt status generally must provide
certification on IRS
Form W-9
or
Form W-8BEN
(as applicable). Amounts held as backup withholding may be
credited against a holders US federal income tax
liability, and a holder may obtain a refund of any excess
amounts withheld under the backup withholding rules by filing
the appropriate claim for refund with the IRS and furnishing any
required information.
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F.
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Dividends
and Paying Agents
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Not applicable.
Not applicable.
We file reports, including this annual report on
Form 20-F,
and other information with the SEC pursuant to the rules and
regulations of the SEC that apply to foreign private issuers.
Any materials filed with the SEC may be inspected without charge
and copied at prescribed rates at its Public Reference Room at
450 Fifth Street, N.W., Washington, D.C. 20459.
Information on the operation of the Public Reference Room may be
obtained by calling the SEC at
1-800-SEC-0330.
This annual report and subsequent public filings with the SEC
will also be available on the website maintained by the SEC at
http://www.sec.gov.
We provide Citibank N.A., as depositary under the deposit
agreement between us, the depositary and registered holders of
the American Depositary Receipts evidencing ADSs, with annual
reports, including a review of operations, and annual audited
consolidated financial statements prepared in conformity with UK
GAAP, together with a reconciliation of net income/(loss) and
total shareholders equity to US GAAP. Upon receipt of
these reports, the depositary is obligated to promptly mail them
to all record holders of ADSs. We also furnish to the
74
depositary all notices of meetings of holders of Ordinary Shares
and other reports and communications that are made generally
available to holders of Ordinary Shares. The depositary
undertakes to mail to all holders of ADSs a notice containing
the information contained in any notice of a shareholders
meeting received by the depositary, or a summary of such
information. The depositary also undertakes to make available to
all holders of ADSs such notices and all other reports and
communications received by the depositary in the same manner as
we make them available to holders of Ordinary Shares.
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Item 11
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Quantitative
and Qualitative Disclosures About Market Risk
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General
Historically, our global operations and our existing liabilities
were exposed to various market risks (i.e. the risk of loss
arising from adverse changes in market rates or prices). Our
principal market risks were:
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foreign exchange rates generating translation
and transaction gains and losses; and
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interest rate risks related to financial and other liabilities.
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We have not entered into any market risk sensitive instruments
for trading purposes. We have not entered into any hedging or
derivative instruments in respect of these exposures.
Foreign
Exchange Rate Risks
We record our transactions and 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 conducting 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 restrict the risk of exchange rate fluctuations.
However, if we should commence commercializing any products in
the U.S., 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 the pound sterling
and/or the
euro.
Interest
Rate Risk
We have no loans at December 31, 2005 and thus not subject
to market risk. Accordingly, we do not hedge any of our interest
rate risks.
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Item 12
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Description
of Securities Other than Equity Securities
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Not applicable.
PART II
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Item 13
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Defaults,
Dividend Arrearages and Delinquencies
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None.
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Item 14
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Material
Modifications to the Rights of Security Holders and Use of
Proceeds
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None.
75
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Item 15
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Controls
and Procedures
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As of the end of the fiscal year ended December 31, 2005,
we conducted an evaluation (under the supervision and with the
participation of our management, including our Chief Executive
Officer and Chief Financial Officer), pursuant to
Rule 13a-15
promulgated under the Securities Exchange Act of 1934, as
amended, of the effectiveness of our disclosure controls and
procedures.
In designing and evaluating our disclosure controls and
procedures, our management recognized that any controls and
procedures, no matter how well designed and operated, can
provide only reasonable, rather than absolute, assurance of
achieving the desired control objectives and management
necessarily was required to apply its judgment in evaluating the
cost-benefit relationship of possible controls and procedures.
Based on the evaluation conducted, our management, including our
Chief Executive Officer and Chief Financial Officer, concluded
that as of the end of the fiscal year such disclosure controls
and procedures were reasonably designed and operating
effectively.
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Item 16A
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Audit
Committee Financial Expert
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Our Board of Directors has determined that John Groom, a member
of our audit committee, is the audit committee financial expert
and an independent director as defined in the Nasdaq Marketplace
Rules.
We have adopted a written Code of Ethics that applies to all
employees and executive officers, including our Chief Executive
Officer and Chief Financial Officer. A copy of our Code of
Ethics has been filed as Exhibit 11.1 to this annual report.
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Item 16C
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Principal
Accountant Fees and Services
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PricewaterhouseCoopers LLP has served as our independent public
auditor for each of the fiscal years ended December 31,
2003, 2004 and 2005.
The following table sets forth the aggregate fees billed by
PricewaterhouseCoopers LLP for professional services in each of
the last two fiscal years:
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2005
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2004
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($000)
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($000)
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Audit fees
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230
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183
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Audit-related fees
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175
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249
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Tax fees
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16
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41
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All other fees
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90
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63
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Total
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511
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536
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Audit fees comprise the work undertaken in auditing the Company
and issuing an audit opinion on its UK statutory accounts. Audit
related fees comprise work associated with SEC regulatory
compliance and work on the Companys quarterly earnings.
Tax fees comprise work relating to tax filing compliance. Other
fees comprise work relating to tax advisory services.
All services provided by our auditor and companies affiliated
with our auditor must be pre-approved by the audit committee.
The annual contract relating to the audit of the financial
statements of the Company must be approved by the audit
committee. Contracts for other non-audit services must also be
approved by the audit committee.
Any requests for services to be provided by the auditor or an
affiliate must be made through the Companys chief
financial officer, who will discuss and seek approval from the
audit committee. The chief financial officer also notifies the
audit committee of the services provided, monitors the costs
incurred and notifies the chairman of the audit committee if the
costs are likely to materially exceed the estimated amount.
76
In accordance with
Regulation S-X,
Rule 2-01,
paragraph (c)(7)(i) no fees for services were approved
pursuant to any waivers of the pre-approval requirement.
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Item 16D
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Exemptions
from the Listing Standards for Audit Committees
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Not Applicable.
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Item 16E
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Purchases
of Equity Securities by the Issuer and Affiliated
Purchasers.
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No purchase of equity securities as registered by the Company
pursuant to section 12 of the Exchange Act were made by or
on behalf of the Company.
PART III
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Item 17
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Financial
Statements
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We are furnishing financial statements pursuant to the
instructions of Item 18 of
Form 20-F.
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Item 18
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Financial
Statements
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See our consolidated financial statements beginning at
page F-1.
Exhibits filed as part of this annual report:
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1
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.1
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Memorandum of Association of the
Company(16)
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1
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.2
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Articles of Association of the
Company(16)
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2
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.1
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Form of Deposit Agreement, dated
as of March 29, 1993, among the Company, Citibank, N.A., as
Depositary, and all holders from time to time of American
Depositary Receipts issued thereunder(1)
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2
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.2
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Amendment No. 1 to Deposit
Agreement, dated as of October 8, 1998, among the Company,
Citibank, N.A., as Depositary, and all holders from time to time
of the American Depositary Receipts issued thereunder(2)
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2
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.3
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Amendment No. 2 to Deposit
Agreement, dated as of September 25, 2002 among the
Company, Citibank N.A., as Depositary, and all holders from time
to time of the American Depositary Receipts issued thereunder(3)
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2
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.4
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Form of Ordinary Share
certificate(10)
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2
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.5
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Form of American Depositary
Receipt evidencing ADSs (included in Exhibit 2.3)(3)
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2
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.6
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Registration Rights Agreement,
dated as of October 21, 1998, by and among Ethical Holdings
plc and Monksland Holdings B.V.(10)
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2
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.7
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Amendment No. 1 to
Registration Rights Agreement and Waiver, dated January 27,
2003, by and among the Company, Elan International Services,
Ltd. and Monksland Holdings B.V.(10)
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2
|
.8
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Second Subscription Agreement,
dated as of November 1999, among Ethical Holdings PLC, Monksland
Holdings B.V. and Elan Corporation PLC(4)
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2
|
.9
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Purchase Agreement, dated as of
June 16, 2000, by and among the Company and the Purchasers
named therein(4)
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2
|
.10
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Registration Rights Agreement,
dated as of November 24, 2000, by and between the Company
and Laxdale Limited(5)
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2
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.11
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Form of Subscription Agreement,
dated as of January 27, 2003 by and among the Company and
the Purchasers named therein (10) (The Company entered into
twenty separate Subscription Agreements on January 27, 2003
all substantially similar in form and content to this form of
Subscription Agreement.)
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2
|
.12
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Form of Registration Rights
Agreement, dated as of January 27, 2003 between the Company
and the Purchasers named therein (10) (The Company entered into
twenty separate Registration Rights Agreements on
January 27, 2003 all substantially similar in form and
content to this form of Registration Rights Agreement.)
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77
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2
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.13
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Securities Purchase Agreement
dated as of December 16, 2005 by and among the Company and
the purchasers named therein(17)
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4
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.1
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Amended and Restated Asset
Purchase Agreement dated September 29, 1999 between Elan
Pharmaceuticals Inc. and the Company(10)
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4
|
.2
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Variation Agreement, undated,
between Elan Pharmaceuticals Inc. and the Company(10)
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4
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.3
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License Agreement, dated
November 24, 2000, between the Company and Laxdale
Limited(6)
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4
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.4
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Option Agreement, dated as of
June 18, 2001, between Elan Pharma International Limited
and the Company(7)
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4
|
.5
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Deed of Variation, dated
January 27, 2003, between Elan Pharma International Limited
and the Company(10)
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4
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.6
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Lease, dated August 6, 2001,
between the Company and LB Strawberry LLC(7)
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4
|
.7
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Amended and Restated Distribution,
Marketing and Option Agreement, dated September 28, 2001,
between Elan Pharmaceuticals, Inc. and the Company(8)
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4
|
.8
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Amended and Restated License and
Supply Agreement, dated March 29, 2002, between Eli Lilly
and Company and the Company(10)
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4
|
.9
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Deed of Variation, dated
January 27, 2003, between Elan Pharmaceuticals Inc. and the
Company(10)
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4
|
.10
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Stock and Intellectual Property
Right Purchase Agreement, dated November 30, 2001, by and
among Abriway International S.A., Sergio Lucero, Francisco
Stefano, Amarin Technologies S.A., Amarin Pharmaceuticals
Company Limited and the Company(7)
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4
|
.11
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Stock Purchase Agreement, dated
November 30, 2001, by and among Abriway International S.A.,
Beta Pharmaceuticals Corporation and the Company(7)
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4
|
.12
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Novation Agreement, dated
November 30, 2001, by and among Beta Pharmaceuticals
Corporation, Amarin Technologies S.A. And the Company(7)
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4
|
.13
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Loan Agreement, dated
September 28, 2001, between Elan Pharma International
Limited and the Company(8)
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4
|
.14
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Deed of Variation, dated
July 19, 2002, amending certain provisions of the Loan
Agreement between the Company and Elan Pharma International
Limited(10)
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4
|
.15
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Deed of Variation No. 2,
dated December 23, 2002, between The Company and Elan
Pharma International Limited(10)
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4
|
.16
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Deed of Variation No. 3,
dated January 27, 2003, between the Company and Elan Pharma
International Limited(10)
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4
|
.17
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The Company 2002 Stock Option
Plan(9)
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4
|
.18
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Agreement Letter, dated
October 21, 2002, between the Company and Security Research
Associates, Inc.(10)
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4
|
.19
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Agreement, dated January 27,
2003, among the Company, Elan International Services, Ltd. and
Monksland Holdings B.V.(10)
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4
|
.20
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Master Agreement, dated
January 27, 2003, between Elan Corporation, plc., Elan
Pharma International Limited, Elan International Services, Ltd.,
Elan Pharmaceuticals, Inc., Monksland Holdings B.V. and the
Company(10)
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4
|
.21
|
|
Form of Warrant Agreement, dated
March 19, 2003, between the Company and individuals
designated by Security Research Associates, Inc. (10) (The
Company entered into seven separate Warrant Agreements on
March 19, 2003 all substantially similar in form and
content to this form of Warrant Agreement)
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4
|
.22
|
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Sale and Purchase Agreement, dated
March 14, 2003, between F.
Hoffmann La Roche Ltd.,
Hoffmann La Roche Inc And the
Company(10)
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4
|
.23
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Share Subscription and Purchase
Agreement dated October 28, 2003 among the Company, Amarin
Pharmaceuticals Company Limited, Watson Pharmaceuticals, Inc.
and Lagrummet December NR 911 AB (under name change to WP
Holdings AB)(12)
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4
|
.24
|
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Asset Purchase Agreement dated
February 11, 2004 between the Company, Amarin
Pharmaceuticals Company Limited and Valeant Pharmaceuticals
International(12)
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78
|
|
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4
|
.25
|
|
Amendment No. 1 to Asset
Purchase Agreement dated February 25, 2004 between the
Company, Amarin Pharmaceuticals Company Limited and Valeant
Pharmaceuticals International(12)
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4
|
.26
|
|
Development Agreement dated
February 25, 2004 between the Company and Valeant
Pharmaceuticals International(12)
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4
|
.27
|
|
Settlement Agreement dated
February 25, 2004 among Elan Corporation plc, Elan Pharma
International Limited, Elan International Services, Ltd, Elan
Pharmaceuticals, Inc., Monksland Holdings BV and the Company(12)
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4
|
.28
|
|
Debenture dated August 4.
2003 made by the Company in favour of Elan Corporation plc as
Trustee(12)
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4
|
.29
|
|
Debenture Amendment Agreement
dated December 23, 2003 between the Company and Elan
Corporation plc as Trustee(12)
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4
|
.30
|
|
Debenture Amendment Agreement
No. 2 dated February 24, 2004 between the Company and
Elan Corporation plc as Trustee(12)
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4
|
.31
|
|
Loan Instrument dated
February 25, 2004 executed by Amarin in favor of Elan
Pharma International Limited(12)
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4
|
.32
|
|
Amended and Restated Master
Agreement dated August 4, 2003 among Elan Corporation plc,
Elan Pharma International Limited, Elan International Services,
Ltd., Elan Pharmaceuticals, Inc., Monksland Holdings BV and the
Company(11)(12)
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4
|
.33
|
|
Amended and Restated Option
Agreement dated August 4, 2003 between the Company and Elan
Pharma International Limited(11)(12)
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4
|
.34
|
|
Deed of Variation No. 2,
dated August 4, 2003, to the Amended and Restated
Distribution, Marketing and Option Agreement between Elan
Pharmaceuticals, Inc. and the Company(11)(12)
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4
|
.35
|
|
Deed of Variation No. 4,
dated August 4, 2003, to Loan Agreement between the Company
and Elan Pharma International Limited(11)(12)
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4
|
.36
|
|
Amendment Agreement No. 1,
dated August 4, 2003, to Amended and Restated Asset
Purchase Agreement among Elan International Services, Ltd., Elan
Pharmaceuticals, Inc. and the Company(11)(12)
|
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4
|
.37
|
|
Warrant dated February 25,
2004 issued by the Company in favor of the Warrant Holders named
therein(12)
|
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4
|
.38
|
|
Amendment Agreement dated
December 23, 2003, between Elan Corporation plc, Elan
Pharma International Limited, Elan Pharmaceuticals, Inc.,
Monksland Holdings BV and the Company(11)(12)
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4
|
.39
|
|
Bridging Loan Agreement dated
December 23, 2003 between the Company and Elan
Pharmaceuticals, Inc.(11)(12)
|
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|
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4
|
.40
|
|
Agreement dated December 23,
2003 between the Company and Elan Pharma International Limited,
amending the Amended and Restated Option Agreement dated
August 4, 2003(11)(12)
|
|
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4
|
.41
|
|
Inventory Buy Back Agreement dated
March 18, 2004 between the Company and Swiftwater Group
LLC(12)
|
|
|
|
|
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|
|
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|
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4
|
.42
|
|
Form of Subscription Agreement,
dated as of October 7, 2004 by and among the Company and
the Purchasers named therein(13) (The Company entered into 14
separate Subscription Agreements on October 7, 2004 all
substantially similar in form and content to this form of
Subscription Agreement.)
|
|
|
|
|
|
|
|
|
|
|
|
4
|
.43
|
|
Form of Registration Rights
Agreement, dated as of October 7, 2004 between the Company
and the Purchasers named therein (13) (The Company entered into
14 separate Registration Rights Agreements on October 7,
2004 all substantially similar in form and content to this form
of Registration Rights Agreement.)
|
|
|
|
|
|
|
|
|
|
|
|
4
|
.44
|
|
Share Purchase Agreement dated
October 8, 2004 between the Company, Vida Capital Partners
Limited and the Vendors named therein relating to the entire
issued share capital of Laxdale Limited(13)
|
|
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|
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4
|
.45
|
|
Escrow Agreement dated
October 8, 2004 among the Company, Belsay Limited and
Simcocks Trust Limited as escrow agent(13)
|
|
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|
|
|
|
|
|
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|
|
4
|
.46
|
|
Loan
Note Redemption Agreement dated October 14, 2004
between Amarin Investment Holding Limited and the Company(13)
|
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4
|
.47
|
|
License and Distribution Agreement
dated March 26,2003 between Laxdale and SCIL Biomedicals
GMBH(14)
|
|
|
|
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|
|
|
|
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|
|
4
|
.48
|
|
License Agreement dated
July 21, 2003 between Laxdale and an undisclosed a third
party(14)
|
|
|
|
|
|
79
|
|
|
|
|
|
4
|
.49
|
|
Settlement agreement dated
27 September 2004 between the Company and Valeant
Pharmaceuticals International(14)
|
|
|
|
|
|
|
|
|
|
|
|
4
|
.50
|
|
Exclusive License Agreement dated
October 8, 2004 between Laxdale and Scarista Limited which
provides Laxdale with exclusive rights to specified intellectual
property of Scarista(14)
|
|
|
|
|
|
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|
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|
|
4
|
.51
|
|
Exclusive License Agreement dated
October 8, 2004 between Laxdale and Scarista Limited
pursuant to which Scarista has the exclusive right to use
certain of Laxdales intellectual property(14)
|
|
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|
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|
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|
|
4
|
.52
|
|
Clinical Supply Agreement between
Laxdale and Nisshin Flour Milling Co., Limited dated
27th October
1999(14)
|
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|
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|
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4
|
.53
|
|
Clinical Trial Agreement dated
March 18, 2005 between Amarin Neuroscience Limited and the
University of Rochester. Pursuant to this agreement the
University is obliged to carry out or to facilitate the carrying
out of a clinical trial research study set forth in a research
protocol on Miraxion in patients with Huntingtons
disease(14)
|
|
|
|
|
|
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|
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|
|
4
|
.54
|
|
License and Distribution Agreement
dated December 20, 2002 between Laxdale Limited and Link
Pharmaceuticals Limited(14)
|
|
|
|
|
|
|
|
|
|
|
|
4
|
.55
|
|
License and Distribution Agreement
dated December 9, 2002 between Laxdale Limited and Juste
S.A.Q.F.(14)
|
|
|
|
|
|
|
|
|
|
|
|
4
|
.56
|
|
Loan
Note Redemption Agreement dated May, 2005 between
Amarin Investment Holding Limited and the Company.(14)
|
|
|
|
|
|
|
|
|
|
|
|
4
|
.57
|
|
Services Agreement dated
June 16, 2005 between Icon Clinical Research Limited and
Amarin Neuroscience Limited.(15)
|
|
|
|
|
|
|
|
|
|
|
|
4
|
.58
|
|
License Agreement dated
December 31, 2005 between Amarin Neuroscience Limited and
Multicell Technologies, Inc.(15)
|
|
|
|
|
|
|
|
|
|
|
|
4
|
.59
|
|
Consultancy Agreement dated
March 29, 2006 between Amarin Corporation plc and Dalriada
Limited*
|
|
|
|
|
|
|
|
|
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|
|
8
|
.1
|
|
Subsidiaries of the Company*
|
|
|
|
|
|
|
|
|
|
|
|
11
|
.1
|
|
Code of Ethics*
|
|
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|
|
|
|
|
|
|
|
|
12
|
.1
|
|
Certification of Richard A.B.
Stewart required by Rl
15d-14(a) of
the Securities Exchange Act of 1934, as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002*
|
|
|
|
|
|
|
|
|
|
|
|
12
|
.2
|
|
Certification of Alan Cooke
required by
Rule 15d-14(a)
of the Securities Exchange Act of 1934, as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002*
|
|
|
|
|
|
|
|
|
|
|
|
13
|
.1
|
|
Certification of Richard A. B.
Stewart required by Section 1350 of Chapter 63 of
Title 18 of the United States Code, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002*
|
|
|
|
|
|
|
|
|
|
|
|
13
|
.2
|
|
Certification of Alan Cooke
required by Section 1350 of Chapter 63 of
Title 18 of the United States Code, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002*
|
|
|
|
|
|
|
|
|
|
|
|
14
|
.1
|
|
Consent of PricewaterhouseCoopers
LLP*
|
|
|
|
|
|
|
|
|
|
|
|
14
|
.2
|
|
Consent of Ernst & Young
LLP*
|
|
|
|
* |
|
Filed herewith |
|
|
|
Confidential treatment requested (the confidential portions of
such exhibits have been omitted and filed separately with the
Securities and Exchange Commission) |
|
(1) |
|
Incorporated herein by reference to certain exhibits to the
Companys Registration Statement on
Form F-1,
File
No. 33-58160,
filed with the Securities and Exchange Commission on
February 11, 1993. |
|
(2) |
|
Incorporated herein by reference to Exhibit (a)(i) to the
Companys Registration Statement on Post-Effective
Amendment No. 1 to
Form F-6,
File
No. 333-5946,
filed with the Securities and Exchange Commission on
October 8, 1998. |
|
(3) |
|
Incorporated herein by reference to Exhibit (a)(ii) to the
Companys Registration Statement on Post-Effective
Amendment No. 2 to
Form F-6,
File
No. 333-5946,
filed with the Securities and Exchange Commission on
September 26, 2002. |
|
(4) |
|
Incorporated herein by reference to certain exhibits to the
Companys Annual Report on
Form 20-F
for the year ended December 31, 1999, filed with the
Securities and Exchange Commission on June 30, 2000. |
80
|
|
|
(5) |
|
Incorporated herein by reference to certain exhibits to the
Companys Registration Statement on
Form F-3,
File
No. 333-13200,
filed with the Securities and Exchange Commission on
February 22, 2001. |
|
(6) |
|
Incorporated herein by reference to certain exhibits to the
Companys Annual Report on
Form 20-F
for the year ended December 31, 2000, filed with the
Securities and Exchange Commission on July 2, 2001. |
|
(7) |
|
Incorporated herein by reference to certain exhibits to the
Companys Annual Report on
Form 20-F
for the year ended December 31, 2001, filed with the
Securities and Exchange Commission on May 9, 2002. |
|
(8) |
|
Incorporated herein by reference to certain exhibits to the
Companys Registration Statement on Pre-Effective Amendment
No. 2 to
Form F-3,
File
No. 333-13200,
filed with the Securities and Exchange Commission on
November 19, 2001. |
|
(9) |
|
Incorporated herein by reference to certain exhibits to the
Companys Registration Statement on
Form S-8,
File
No. 333-101775,
filed with the Securities and Exchange Commission on
December 11, 2002. |
|
(10) |
|
Incorporated herein by reference to certain exhibits to the
Companys Annual Report on
Form 20-F
for the year ended December 31, 2002, filed with the
Securities and Exchange Commission on April 24, 2003. |
|
(11) |
|
These agreements are no longer in effect as a result of
superseding agreements entered into by the Company. |
|
(12) |
|
Incorporated herein by reference to certain exhibits to the
Companys Annual Report on
Form 20-F
for the year ended December 31, 2003, filed with the
Securities and Exchange Commission on March 31, 2004. |
|
(13) |
|
Incorporated herein by reference to certain exhibits to the
Companys Registration Statement on
Form F-3,
File
No. 333-121431,
filed with the Securities and Exchange Commission on
December 20, 2004. |
|
(14) |
|
Incorporated herein by reference to certain exhibits to the
Companys Annual Report on
Form 20-F
for the year ended December 31, 2004, filed with the
Securities and Exchange Commission on April 1, 2005. |
|
(15) |
|
Incorporated herein by reference to certain exhibits to the
Companys Registration Statement on
Form F-3,
File
No. 333-131479,
filed with the Securities and Exchange Commission on
February 2, 2006. |
|
(16) |
|
Incorporated by reference herein to certain exhibits in the
Companys report on
Form 6-K,
filed with the Securities and Exchange Commission on
December 12, 2005. |
|
(17) |
|
Incorporated by reference herein to certain exhibits in the
Companys report on
Form 6-K,
filed with the Securities and Exchange Commission on
December 28, 2005. |
81
SIGNATURES
The registrant hereby certifies that it meets all of the
requirements for filing on
Form 20-F
and that it has duly caused and authorized the undersigned to
sign this annual report on its behalf.
AMARIN CORPORATION PLC
|
|
By: |
/s/ RICHARD
A. B. STEWART
|
Richard A. B. Stewart
Chief Executive Officer
Date: March 30, 2006
82
Amarin
Corporation plc
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Shareholders of
Amarin Corporation plc
In our opinion, based on our audits and the report of other
auditors, the accompanying balance sheets and the related
consolidated profit and loss accounts, statements of total
recognised gains and losses, reconciliations of movements in
shareholders funds and cash flow statements present
fairly, in all material respects, the financial position of
Amarin Corporation plc and its subsidiaries at December 31,
2005, December 31, 2004, and December 31, 2003, and
the results of their operations and their cash flows for the
years then ended, in conformity with principles generally
accepted in the United Kingdom. These financial statements are
the responsibility of the Companys management; our
responsibility is to express an opinion on these financial
statements based on our audits. We did not audit the financial
statements of Amarin Neuroscience Limited, a wholly owned
subsidiary, whose statements reflect net liabilities of
£2,575,266 ($4,978,095), as of December 31, 2004, and
operating loss of £1,428,408 ($2,639,530) for the period
October 9, 2004 to December 31, 2004. Those statements
were audited by other auditors whose report thereon has been
furnished to us, and our opinion expressed herein, insofar as it
relates to the amounts included for Amarin Neuroscience Limited,
is based solely on the report of the other auditors. We
conducted our audits of these statements in accordance with the
standards of the Public Company Accounting Oversight Board
(United States) and International Standards on Auditing (UK and
Ireland), which require that we plan and perform the audit to
obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes
examining, on a test basis, evidence supporting the amounts and
disclosures in the financial statements, assessing the
accounting principles used and significant estimates made by
management, and evaluating the overall financial statement
presentation. We believe our audits provide a reasonable basis
for our opinion.
Accounting principles generally accepted in the United Kingdom
vary in certain significant respects from accounting principles
in the United States of America. Information relating to the
nature and effect of such differences is presented in
Notes 42 and 43 to the consolidated financial statements.
PricewaterhouseCoopers LLP
Chartered Accountants and Registered Auditors
Cambridge, England
March 30, 2006
F-1
Amarin
Neuroscience Limited (formerly Laxdale Limited)
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors
Amarin Neuroscience Limited
We have audited the accompanying balance sheet of Amarin
Neuroscience Limited as of December 31, 2004 and the
related profit and loss account and statements of total
recognised gains and losses and cash flows for the period from
October 9, 2004 to December 31, 2004 (not
presented separately herein). These financial statements are the
responsibility of the Companys management. Our
responsibility is to express an opinion on these financial
statements based on our audit.
We conducted our audit in accordance with United Kingdom
auditing standards and the standards of the Public Company
Accounting Oversight Board (United States). Those standards
require that we plan and perform the audit to obtain reasonable
assurance about whether the financial statements are free of
material misstatement. We were not engaged to perform an audit
of the Companys internal control over financial reporting.
Our audit included consideration of internal controls over
financial reporting as a basis for designing audit procedures
that are appropriate in the circumstances, but not for the
purpose of expressing an opinion on the effectiveness of the
Companys internal controls over financial reporting.
Accordingly, we express no such opinion. An audit also includes
examining, on a test basis, evidence supporting the amounts and
disclosures in the financial statements, assessing the
accounting principles used and significant estimates made by
management, and evaluating the overall financial statement
presentation. We believe that our audit provides a reasonable
basis for our opinion.
In our opinion, the financial statements referred to above
present fairly, in all material respects, the financial position
of the Company as at December 31, 2004 and the results of
its operations and its cash flows for the period from
October 9, 2004 to December 31, 2004, in conformity
with accounting principles generally accepted in the United
Kingdom which differ in certain respects from those generally
accepted in the United States (see Note 22 of Notes to the
Financial Statements).
The financial statements referred to above have been prepared
assuming that the Company will continue as a going concern. As
discussed in Note 1 to the financial statements the Company
is reliant upon sufficient funding continuing to be available
from the Companys parent company, Amarin Corporation plc,
to meet ongoing working capital requirements. This in turn is
dependent upon Amarin Corporation plc obtaining additional
funding. These conditions raise substantial doubt about the
Companys ability to continue as a going concern. The
directors plans in regard to these matters are also
described in Note 1. The financial statements do not
include any adjustments that might result from the outcome of
this uncertainty.
Ernst & Young LLP
Glasgow, Scotland
April 1, 2005
F-2
Amarin
Corporation plc
Consolidated
profit and loss account for year ended 31 December
2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
Total
|
|
|
Total
|
|
|
|
Note
|
|
|
2005
|
|
|
2004*
|
|
|
2003*
|
|
|
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Turnover continuing
operations
|
|
|
5
|
|
|
|
500
|
|
|
|
|
|
|
|
|
|
Turnover discontinued
operations
|
|
|
5
|
|
|
|
|
|
|
|
1,017
|
|
|
|
7,365
|
|
Cost of
sales discontinued operations
|
|
|
7
|
|
|
|
|
|
|
|
(107
|
)
|
|
|
(11,912
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
profit continuing operations
|
|
|
|
|
|
|
500
|
|
|
|
|
|
|
|
|
|
Gross
profit/(loss) discontinued operations
|
|
|
|
|
|
|
|
|
|
|
910
|
|
|
|
(4,547
|
)
|
Net operating (expenses)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing operations
|
|
|
|
|
|
|
(19,408
|
)
|
|
|
(9,927
|
)
|
|
|
(6,200
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total continuing
operations
|
|
|
|
|
|
|
(19,408
|
)
|
|
|
(9,927
|
)
|
|
|
(6,200
|
)
|
Discontinued
operations
|
|
|
|
|
|
|
|
|
|
|
(2,075
|
)
|
|
|
(28,074
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net operating
expenses
|
|
|
8
|
|
|
|
(19,408
|
)
|
|
|
(12,002
|
)
|
|
|
(34,274
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating (loss)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing operations
|
|
|
|
|
|
|
(18,908
|
)
|
|
|
(9,927
|
)
|
|
|
(6,200
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total continuing
operations
|
|
|
|
|
|
|
(18,908
|
)
|
|
|
(9,927
|
)
|
|
|
(6,200
|
)
|
Discontinued
operations
|
|
|
|
|
|
|
|
|
|
|
(1,165
|
)
|
|
|
(32,621
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
(loss)
|
|
|
|
|
|
|
(18,908
|
)
|
|
|
(11,092
|
)
|
|
|
(38,821
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Profit/(loss) on disposal of
operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Profit on disposal of Swedish
operations
|
|
|
11
|
|
|
|
|
|
|
|
750
|
|
|
|
13,076
|
|
(Loss) on disposal of US
operations and certain products
|
|
|
11
|
|
|
|
|
|
|
|
(3,143
|
)
|
|
|
|
|
Gain on settlement of debt on
related sale of distribution rights
|
|
|
11
|
|
|
|
|
|
|
|
24,608
|
|
|
|
|
|
Interest receivable and similar
income
|
|
|
12
|
|
|
|
395
|
|
|
|
548
|
|
|
|
65
|
|
Interest payable and similar
charges
|
|
|
13
|
|
|
|
(892
|
)
|
|
|
(326
|
)
|
|
|
(900
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss)/profit on ordinary
activities before taxation
|
|
|
14
|
|
|
|
(19,405
|
)
|
|
|
11,345
|
|
|
|
(26,580
|
)
|
Tax credit/(charge) on
(loss)/profit on ordinary activities
|
|
|
15
|
|
|
|
698
|
|
|
|
(7,333
|
)
|
|
|
7,356
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss)/profit for the financial
year
|
|
|
|
|
|
|
(18,707
|
)
|
|
|
4,012
|
|
|
|
(19,224
|
)
|
Dividends
credit/(payable) non-equity
|
|
|
18
|
|
|
|
|
|
|
|
643
|
|
|
|
(24
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss)/retained profit for the
financial year
|
|
|
32
|
|
|
|
(18,707
|
)
|
|
|
4,655
|
|
|
|
(19,248
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
US Cents
|
|
|
US Cents
|
|
|
US Cents
|
|
|
Basic (loss)/profit per
ordinary share
|
|
|
17
|
|
|
|
(40.0
|
)
|
|
|
20.7
|
|
|
|
(112.6
|
)
|
Fully diluted (loss)/profit per
ordinary share
|
|
|
17
|
|
|
|
(40.0
|
)
|
|
|
20.7
|
|
|
|
(112.6
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
There is no difference between the (loss)/profit on ordinary
activities before taxation and (loss)/retained profit for the
years stated above, and their historical cost equivalents.
The company has no recognised gains and losses other than those
included in the results above and therefore no separate
statement of total recognised gains and losses has been
presented.
|
|
|
* |
|
Prior year exceptional items are included in note 4. |
The accompanying notes are an integral part of the financial
statements.
F-3
Amarin
Corporation plc
Reconciliation
of movements in group shareholders
funds/(deficit)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
(Loss)/profit for the financial
year
|
|
|
|
|
|
|
(18,707
|
)
|
|
|
4,012
|
|
|
|
(19,224
|
)
|
Dividends non
equity credit/(charge)
|
|
|
18
|
|
|
|
|
|
|
|
643
|
|
|
|
(24
|
)
|
New share capital issued
|
|
|
30
|
|
|
|
44,538
|
|
|
|
19,556
|
|
|
|
21,212
|
|
Share issuance costs
|
|
|
32
|
|
|
|
(3,944
|
)
|
|
|
(953
|
)
|
|
|
(2,104
|
)
|
Treasury shares
|
|
|
32
|
|
|
|
|
|
|
|
(217
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in shareholders
funds/(deficit)
|
|
|
|
|
|
|
21,887
|
|
|
|
23,041
|
|
|
|
(140
|
)
|
Opening shareholders
funds/(deficit)
|
|
|
|
|
|
|
16,693
|
|
|
|
(6,348
|
)
|
|
|
(6,208
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Closing shareholders
funds/(deficit)
|
|
|
|
|
|
|
38,580
|
|
|
|
16,693
|
|
|
|
(6,348
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of the financial
statements.
F-4
Amarin
Corporation plc
Balance
sheets at 31 December 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Group
|
|
|
Company
|
|
|
|
Note
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Fixed assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible assets
|
|
|
19
|
|
|
|
9,627
|
|
|
|
10,302
|
|
|
|
31,749
|
|
|
|
3,314
|
|
|
|
3,546
|
|
|
|
31,749
|
|
Tangible assets
|
|
|
20
|
|
|
|
460
|
|
|
|
427
|
|
|
|
1,031
|
|
|
|
194
|
|
|
|
223
|
|
|
|
300
|
|
Investments
|
|
|
21
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,253
|
|
|
|
6,253
|
|
|
|
1,660
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,087
|
|
|
|
10,729
|
|
|
|
32,780
|
|
|
|
9,761
|
|
|
|
10,022
|
|
|
|
33,709
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
|
|
|
22
|
|
|
|
|
|
|
|
|
|
|
|
2,651
|
|
|
|
|
|
|
|
|
|
|
|
2,651
|
|
Deferred tax asset
|
|
|
15
|
|
|
|
|
|
|
|
|
|
|
|
7,500
|
|
|
|
|
|
|
|
|
|
|
|
7,500
|
|
Debtors
|
|
|
23
|
|
|
|
2,766
|
|
|
|
2,003
|
|
|
|
2,349
|
|
|
|
13,661
|
|
|
|
6,069
|
|
|
|
3,766
|
|
Cash at bank and in hand
|
|
|
|
|
|
|
33,907
|
|
|
|
10,989
|
|
|
|
2,097
|
|
|
|
33,691
|
|
|
|
10,895
|
|
|
|
1,134
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
36,673
|
|
|
|
12,992
|
|
|
|
14,597
|
|
|
|
47,352
|
|
|
|
16,964
|
|
|
|
15,051
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Creditors: amounts falling due
within one year
|
|
|
25
|
|
|
|
(8,000
|
)
|
|
|
(4,341
|
)
|
|
|
(53,725
|
)
|
|
|
(19,763
|
)
|
|
|
(18,546
|
)
|
|
|
(67,092
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net current
assets/(liabilities)
|
|
|
|
|
|
|
28,673
|
|
|
|
8,651
|
|
|
|
(39,128
|
)
|
|
|
27,589
|
|
|
|
(1,582
|
)
|
|
|
(52,041
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets less current
liabilities
|
|
|
|
|
|
|
38,760
|
|
|
|
19,380
|
|
|
|
(6,348
|
)
|
|
|
37,350
|
|
|
|
8,440
|
|
|
|
(18,332
|
)
|
Creditors: amounts falling due
after more than one year
|
|
|
26
|
|
|
|
(165
|
)
|
|
|
|
|
|
|
|
|
|
|
(151
|
)
|
|
|
|
|
|
|
|
|
Convertible loan note
|
|
|
27
|
|
|
|
|
|
|
|
(2,000
|
)
|
|
|
|
|
|
|
|
|
|
|
(2,000
|
)
|
|
|
|
|
Provisions for liabilities and
charges
|
|
|
28
|
|
|
|
(15
|
)
|
|
|
(687
|
)
|
|
|
|
|
|
|
(15
|
)
|
|
|
(687
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
assets/(liabilities)
|
|
|
|
|
|
|
38,580
|
|
|
|
16,693
|
|
|
|
(6,348
|
)
|
|
|
37,184
|
|
|
|
5,753
|
|
|
|
(18,332
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital and reserves
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Called up share capital
|
|
|
30
|
|
|
|
6,778
|
|
|
|
3,206
|
|
|
|
29,088
|
|
|
|
6,778
|
|
|
|
3,206
|
|
|
|
29,088
|
|
Capital redemption reserve
|
|
|
32
|
|
|
|
27,633
|
|
|
|
27,633
|
|
|
|
|
|
|
|
27,633
|
|
|
|
27,633
|
|
|
|
|
|
Treasury shares
|
|
|
32
|
|
|
|
(217
|
)
|
|
|
(217
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share premium account
|
|
|
32
|
|
|
|
124,097
|
|
|
|
87,075
|
|
|
|
70,223
|
|
|
|
121,371
|
|
|
|
84,349
|
|
|
|
67,497
|
|
Profit and loss account
|
|
|
32
|
|
|
|
(119,711
|
)
|
|
|
(101,004
|
)
|
|
|
(105,659
|
)
|
|
|
(118,598
|
)
|
|
|
(109,435
|
)
|
|
|
(114,917
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total equity shareholders
funds/(deficit)
|
|
|
|
|
|
|
38,580
|
|
|
|
16,693
|
|
|
|
(6,348
|
)
|
|
|
37,184
|
|
|
|
5,753
|
|
|
|
(18,332
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of the financial
statements.
F-5
Amarin
Corporation plc
Consolidated
cash flow statement for the year ended 31 December
2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Net cash outflow from operating
activities
|
|
|
|
|
|
|
(18,115
|
)
|
|
|
(10,140
|
)
|
|
|
(15,051
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Returns on investment and
servicing of finance
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest received
|
|
|
|
|
|
|
395
|
|
|
|
139
|
|
|
|
65
|
|
Interest paid on loans and
overdrafts
|
|
|
|
|
|
|
(62
|
)
|
|
|
(173
|
)
|
|
|
(2,726
|
)
|
Interest paid on finance leases
|
|
|
|
|
|
|
(3
|
)
|
|
|
|
|
|
|
(31
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash inflow/(outflow) from
returns on investments and servicing finance
|
|
|
|
|
|
|
330
|
|
|
|
(34
|
)
|
|
|
(2,692
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Taxation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporation tax refund/(paid)
|
|
|
|
|
|
|
479
|
|
|
|
(553
|
)
|
|
|
(2,761
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditure and
financial investment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of intangible fixed assets
|
|
|
|
|
|
|
|
|
|
|
(7,894
|
)
|
|
|
(16,102
|
)
|
Purchase of tangible fixed assets
|
|
|
|
|
|
|
(135
|
)
|
|
|
(9
|
)
|
|
|
(662
|
)
|
Proceeds on sale of intangible
fixed assets
|
|
|
|
|
|
|
|
|
|
|
36,400
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (outflow)/inflow from
capital expenditure and financial investment
|
|
|
|
|
|
|
(135
|
)
|
|
|
28,497
|
|
|
|
(16,764
|
)
|
Acquisitions and
disposals
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition costs for purchase of
Amarin Neuroscience Limited
|
|
|
3
|
|
|
|
|
|
|
|
(813
|
)
|
|
|
|
|
Net overdrafts and loans acquired
on the acquisition of Amarin Neuroscience Limited
|
|
|
3
|
|
|
|
|
|
|
|
(2,740
|
)
|
|
|
|
|
Cash outflow on disposal of Amarin
Pharmaceuticals Inc shares and US operations
|
|
|
11
|
|
|
|
|
|
|
|
(10,167
|
)
|
|
|
|
|
Cash eliminated on disposal of US
operations
|
|
|
11
|
|
|
|
|
|
|
|
(1,801
|
)
|
|
|
|
|
Cash received on disposal of
Swedish operations
|
|
|
11
|
|
|
|
|
|
|
|
750
|
|
|
|
13,375
|
|
Cash balance gained on disposal of
Swedish operations
|
|
|
11
|
|
|
|
|
|
|
|
|
|
|
|
329
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash (outflow)/inflow before
management of liquid resources and financing
|
|
|
|
|
|
|
(17,441
|
)
|
|
|
2,999
|
|
|
|
(23,564
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issue of ordinary share capital
|
|
|
|
|
|
|
42,538
|
|
|
|
12,775
|
|
|
|
21,212
|
|
Expenses of issue of ordinary
share capital
|
|
|
32
|
|
|
|
(1,344
|
)
|
|
|
(953
|
)
|
|
|
(2,104
|
)
|
New loans
|
|
|
|
|
|
|
|
|
|
|
11,894
|
|
|
|
|
|
Repayment of principal on bank and
other loans
|
|
|
38
|
|
|
|
|
|
|
|
(18,195
|
)
|
|
|
(17,500
|
)
|
Repayment of principal under
finance leases
|
|
|
37
|
|
|
|
(8
|
)
|
|
|
|
|
|
|
(212
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash inflow from
financing
|
|
|
|
|
|
|
41,186
|
|
|
|
5,521
|
|
|
|
1,396
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/(decrease) in
cash
|
|
|
36
|
|
|
|
23,745
|
|
|
|
8,520
|
|
|
|
(22,168
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of the financial
statements.
F-6
Amarin
Corporation plc
Reconciliation
of operating loss to net cash outflow from operating
activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Continuing operations
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss from continuing
operations
|
|
|
(18,908
|
)
|
|
|
(9,927
|
)
|
|
|
(6,200
|
)
|
Depreciation on tangible fixed
assets
|
|
|
135
|
|
|
|
155
|
|
|
|
95
|
|
Amortization of intangible fixed
assets
|
|
|
675
|
|
|
|
599
|
|
|
|
576
|
|
(Increase) in trade debtors
|
|
|
|
|
|
|
|
|
|
|
(21
|
)
|
(Increase)/decrease in other
debtors
|
|
|
(560
|
)
|
|
|
661
|
|
|
|
(55
|
)
|
Decrease/(increase) in prepayments
and accrued income
|
|
|
6
|
|
|
|
(399
|
)
|
|
|
(217
|
)
|
(Decrease)/increase in trade
creditors
|
|
|
(309
|
)
|
|
|
421
|
|
|
|
648
|
|
Increase/(decrease) in other
creditors
|
|
|
641
|
|
|
|
(4,066
|
)
|
|
|
|
|
(Decrease)/increase in other
taxation and social security
|
|
|
(78
|
)
|
|
|
77
|
|
|
|
(34
|
)
|
Increase in accruals and deferred
income
|
|
|
955
|
|
|
|
1,320
|
|
|
|
299
|
|
(Decrease)/increase in provisions
|
|
|
(672
|
)
|
|
|
32
|
|
|
|
(50
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash outflow from continuing
operating activities
|
|
|
(18,115
|
)
|
|
|
(11,127
|
)
|
|
|
(4,959
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Discontinued
operations
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss from discontinued
operations
|
|
|
|
|
|
|
(1,165
|
)
|
|
|
(32,621
|
)
|
Depreciation on tangible fixed
assets
|
|
|
|
|
|
|
|
|
|
|
456
|
|
Amortization of intangible fixed
assets
|
|
|
|
|
|
|
|
|
|
|
4,890
|
|
Impairment of intangible fixed
assets
|
|
|
|
|
|
|
|
|
|
|
10,095
|
|
(Increase)/decrease in stocks
|
|
|
|
|
|
|
(550
|
)
|
|
|
5,016
|
|
Decrease in trade debtors
|
|
|
|
|
|
|
418
|
|
|
|
12,521
|
|
Decrease in other debtors
|
|
|
|
|
|
|
107
|
|
|
|
420
|
|
Decrease/(increase) in prepayments
and accrued income
|
|
|
|
|
|
|
860
|
|
|
|
(293
|
)
|
(Decrease)/increase in trade
creditors
|
|
|
|
|
|
|
(2,546
|
)
|
|
|
193
|
|
Increase/(decrease) in other
creditors
|
|
|
|
|
|
|
3,784
|
|
|
|
(14,786
|
)
|
(Decrease) in other taxation and
social security
|
|
|
|
|
|
|
(45
|
)
|
|
|
(236
|
)
|
Increase in accruals and deferred
income
|
|
|
|
|
|
|
124
|
|
|
|
4,253
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash inflow/(outflow) from
discontinued operating activities
|
|
|
|
|
|
|
987
|
|
|
|
(10,092
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net cash outflow from
operating activities
|
|
|
(18,115
|
)
|
|
|
(10,140
|
)
|
|
|
(15,051
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Details of exceptional cashflows are discussed in note 4.
The accompanying notes are an integral part of the financial
statements.
F-7
Amarin
Corporation plc
Notes to
the financial statements
for the year ended 31 December 2005
Going
concern and liquidity
At December 31, 2005, Amarin had a cash balance of
$33.9 million and the directors forecast that the Company
will have sufficient cash to fund operations into the fourth
quarter of 2007. Amarin raised gross proceeds of
$46.3 million in aggregate over the nine month period ended
January 31, 2006. The directors therefore believe that it
is appropriate that these financial statements are prepared on a
going concern basis. This basis of preparation assumes that the
Company will continue in operational existence for the
foreseeable future.
|
|
2.
|
Principal
accounting policies
|
The financial statements have been prepared in accordance with
the Companies Act 1985 and applicable accounting standards in
the United Kingdom. A summary of the more important group
accounting policies, which have been reviewed by the Board in
accordance with Financial Reporting Standard (FRS)
18 Accounting Policies and which have been applied
consistently, is set out below.
The Company has taken the exemption permitted within FRS 25
Financial instruments: disclosure and presentation
from restating comparative amounts. The Companys
preference shares and the related dividends have therefore not
been reclassified as liabilities and interest respectively.
Basis of
accounting
The financial statements are prepared in accordance with the
historical cost convention.
Basis of
consolidation
The consolidated financial statements include the Company and
all its subsidiary undertakings. The turnover and results of
subsidiary companies are included in the financial statements
from the date of acquisition.
In the case of disposals, turnover and results are included up
to the date control passes to the new owner.
Goodwill
Goodwill arising on consolidation represents the excess of the
fair value of the consideration given over the fair value of the
identifiable net assets acquired. Goodwill thus arising is
capitalised and amortized over its useful economic life.
Intangible fixed assets are recognized when they meet the
definitions set out in accounting standards. FRS 7 Fair
values in acquisition accounting refers to separability
(where items can be disposed of separately from the company as a
whole) and control (e.g. via custody or legal/contractual
rights). FRS 10 Goodwill and intangible assets
refers to reliable measurement. The Group has applied these
standards to the acquisition of Amarin Neuroscience Limited (see
note 3) such that the value of the intangible fixed
asset, as supported by risk adjusted discounted cashflow
analysis, is capped to ensure negative goodwill does not arise.
Tangible
fixed assets and intangible fixed assets
Tangible and intangible fixed assets are stated at cost, being
their purchase cost, together with any incidental expenses of
acquisition.
F-8
Depreciation/amortization is calculated so as to write off the
cost of tangible/intangible fixed assets less their estimated
residual values, on a straight line basis over the expected
useful economic lives of the assets concerned. The principal
annual rates used for this purpose are:
|
|
|
|
|
Plant and equipment
|
|
|
10-20%
|
|
Motor vehicles
|
|
|
25%
|
|
Fixtures and fittings
|
|
|
20%
|
|
Computer equipment
|
|
|
33.33%
|
|
Leasehold land and buildings are amortized over the period of
the lease.
Intangible fixed assets are amortized on a straight line basis
over the period in which the Group is expected to benefit from
these assets.
Evaluation
of assets for impairment
The Group reviews its long-lived assets for possible impairment
when a triggering event is identified by comparing their
discounted expected future cash flows or evidence of net
realizable value to their carrying amount. An impairment loss is
recognized if the recoverable amount is less than the carrying
amount of the asset.
Fixed
asset investments
Fixed asset investments are shown at cost less any provision for
impairment.
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. All research and development costs
are written off as incurred and are included within operating
expenses, as disclosed in note 8. Research and development
costs include staff costs, professional and contractor fees,
materials and external services.
Pre-launch
costs
Prior to launch of a new pharmaceutical product, the Group may
incur significant pre-launch marketing costs. Such costs are
expensed as incurred.
Advertising
costs
The Group has adopted an accounting policy for advertising costs
whereby they are expensed as incurred. For the year ended
31 December 2005 costs incurred were $nil (31 December
2004:$nil, 31 December 2003: $250,000).
Stocks
and work in progress
Stocks and work in progress are stated at the lower of cost and
net realizable value. In general, cost is determined on a
first in, first out basis and includes transport and
handling costs. In the case of manufactured products, cost
includes all direct expenditure and production overheads based
on the normal level of activity. Where necessary, provision is
made for obsolete, slow moving and defective stocks.
Finance
and operating leases
Costs in respect of operating leases are charged to the profit
and loss account on a straight-line basis over the lease term.
Where fixed assets are financed by leasing arrangements which
transfer to the Group substantially all the benefits and risks
of ownership, the assets are treated as if they had been
purchased outright and are included in tangible fixed assets.
The capital element of the leasing commitments is shown as
obligations under finance leases. The lease rentals are treated
as consisting of capital and interest elements. The capital
element is applied to reduce the outstanding obligations and the
interest element is charged against profit in proportion to the
reducing capital element outstanding. Assets held under finance
leases are depreciated over the shorter of the lease terms and
the useful lives of equivalent owned assets.
F-9
Foreign
currencies
Where it is considered that the functional currency of an
operation is US dollars, the financial statements are expressed
in US dollars on the following basis:
a. Fixed assets are translated into US dollars at the rates
ruling on the date of acquisition.
b. Monetary assets and liabilities denominated in a foreign
currency are translated into US dollars at the foreign exchange
rates ruling at the balance sheet date.
c. Revenue and expenses in foreign currencies are recorded
in US dollars at the rates ruling for the month of the
transactions.
d. Any gains or losses arising on translation are reported
as part of profit.
In certain circumstances when a subsidiarys operations are
very closely interlinked with those of the company, the temporal
method is used on consolidation. Under the temporal method all
of the subsidiarys transactions are treated as if they had
been entered into by the company itself and all of the
subsidiarys assets and liabilities are treated as though
they belong directly to the company. Amarin considers that its
acquired subsidiary, Amarin Neuroscience Limited (formerly
Laxdale Limited), whose functional currency is sterling, and its
newly formed subsidiary, Amarin Ireland Pharmaceuticals, whose
functional currency is Euro, both fulfil the criteria for use of
the temporal method and accordingly, they have been translated
for consolidation on the basis described by points a-d above.
For other operations, assets and liabilities of subsidiaries are
translated into the Groups functional currency at rates of
exchange ruling at the end of the financial year and the results
of subsidiaries are translated at the average rate of exchange
for the year. Differences on exchange arising from the
retranslation of the opening net investment in subsidiary
companies, and from the translation of the results of those
companies at average rate, are taken to reserves and are
reported in the statement of total recognized gains and losses.
This method is known as the closing rate method.
All other foreign exchange differences are taken to the profit
and loss account in the year in which they arise.
Financial
instruments
Current asset investments are stated at the lower of cost and
net realizable value. If there is no longer any market available
for them, then the carrying value will be written down
accordingly. Gains or losses on sale of such items will be
recognized in the profit and loss account in the period in which
the transaction takes place.
All borrowings are initially stated at the amount of
consideration received. Finance costs are charged to the profit
and loss account over the term of the borrowing and represent a
constant proportion of capital repayment outstanding.
Turnover
Revenues exclude value added tax, sales between group companies
and trade discounts. Revenues from pharmaceutical product sales
and royalties represent the invoice value of products delivered
to the customer, less trade discounts. The Group makes
provisions for product returns based on specific product by
product sales history and the value of product returns is taken
as a deduction from revenue.
Royalty income is recognized when earned, based on related sales
of products under agreements providing for royalties and is
included under the heading royalties and product
sales. All such revenue relates to operations that are
classified in 2004 as discontinued following the disposal of our
former subsidiaries Amarin Pharmaceuticals, Inc
(API) and Amarin Development (Sweden) AB
(ADAB).
Income under license agreements is recognized when amounts have
been earned through the achievement of specific milestones set
forth in those agreements
and/or the
costs to attain those milestones have been incurred by the
Group. A minority of the license agreements provide that if the
Group materially breaches the agreement or fails to achieve
required milestones, the Group would be required to refund all
or a specified portion of the income
F-10
received under the agreement. No provision is included for
repayments of such income if the directors consider that this
eventuality is remote. All such revenue under this minority of
license agreements relates to operations that are classified in
2004 as discontinued following the disposal of API and ADAB.
Deferred
taxation
Deferred taxation is provided in full on timing differences that
result in an obligation at the balance sheet date to pay more
tax, or a right to pay less tax, at a future date, at rates
expected to apply when they crystallize based on current tax
rates and law. Deferred tax assets are recognized to the extent
that they are regarded as recoverable. Deferred tax assets and
liabilities are not discounted.
Convertible
debt
Convertible debt is initially stated at the amount of the net
proceeds after deduction of issue costs. The carrying amount is
increased by the amortized finance costs each year and reduced
by the interest paid. The finance cost is calculated based on
the interest rate specified in the agreement. Convertible debt
is reported as a liability until conversion occurs.
Pension
costs
The Group contributes a set proportion of certain
employees gross salary to defined contribution (money
purchase) pension schemes. The pension costs charged to the
profit and loss account represent the amount of contributions
payable in respect of the accounting period.
The Group provides no other post retirement benefits to its
employees.
Short
term investments
Bank deposits which are not repayable on demand are treated as
short term investments in accordance with FRS 1 (Revised
1996) Cashflow statements. Movements in such
investments are included under Management of liquid
resources in the Groups cash flow statement.
Share
schemes
In accordance with the provisions of Urgent Issues Task Force
Abstract (UITF) 17 (revised
2003) Employee share schemes, the Group makes
charges to the profit and loss account when options are granted,
the charge being the market value of the shares at the date of
grant less the exercise price of the options. The charge is
reflected in the consolidated profit and loss account with an
offsetting credit to reserves.
Employers National Insurance and similar taxes arise on
the exercise of certain share options. In accordance with UITF
Abstract 25 National Insurance contributions on share
options gains a provision is made, calculated using the
market price at the balance sheet date, pro-rated over the
vesting period of the options.
Risks and
uncertainties
The value of the Groups patent and proprietary rights will
be affected by its ability to obtain and preserve patent
protection for its products and trade secrets, and by the
emergence of competing technologies over time. In particular,
the value of the intangible assets described in note 19
could be severely affected by changes in the status of the
Groups patent and proprietary rights.
Use of
estimates
The preparation of financial statements in conformity with UK
GAAP requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of
the financial statements and the reported amounts of revenues
and expenses during the reporting period. Actual results could
differ from those estimates.
F-11
Inventory and returns provisions are calculated by projecting
forward historical trends and take account of third party data
including wholesaler inventory and prescriptions.
Nature of
operations
During 2003 the principal activities of the Group comprised the
marketing and distribution of pharmaceutical products and the
provision of drug delivery and development services to third
party pharmaceutical companies. Following the sale of the
Groups US operations on 25 February 2004 and its drug
delivery business on 28 October 2003, and the acquisition
of Laxdale Limited on 8 October 2004, the Group refocused
as a neuroscience organization focused on the research,
development and commercialization of novel drugs for the
treatment of central nervous system disorders.
Restatement
of comparatives
On 28 October 2003, the Group disposed of its entire
interests in its Swedish drug delivery and development business
comprising Gacell Holdings AB and Amarin Development (Sweden)
AB. On 25 February 2004, the Group disposed of its entire
interests in Amarin Pharmaceuticals Inc. In 2004, in accordance
with UK GAAP (FRS 3 Reporting Financial
Performance), the Group classified both these transactions
as discontinued and restated the comparatives on this basis.
Patent
costs
The Group undertakes to protect its intellectual property using
patent applications. Costs associated with such applications are
written off as incurred.
Treasury
shares
During October 2004, Amarin concluded the acquisition of Amarin
Neuroscience Limited. Amarin Neuroscience Limited has a
shareholding in Amarin dating back to November 2000. Under UITF
37 `Purchases and sales of own shares these shares are
re-classified as `treasury shares from investments, where
they are recorded in Amarin Neurosciences single entity
financial statements, and included as a deduction from
shareholders funds. These shares are carried at the fair
value, being market value, as at the date of acquisition,
8 October 2004.
Government
grants
During 2005, the group received a grant under an EU program.
Amounts received under the grant are used to defray specifically
qualifying research and development expenditure and are offset
against these costs in the accounts. Grants relating to
categories of operating expenditures are credited to the profit
and loss account (as other operating income) in the period in
which the expenditure to which they relate is charged. The total
amount offset in 2005 was $2,000 (nil in 2004 and 2003). There
is no provision for repayment of this grant.
On October 8, 2004, Amarin Corporation plc, declared its
offer for the shares of Amarin Neuroscience Limited (formerly
Laxdale Limited) wholly unconditional and on that date acquired
100% of the outstanding Laxdale shares (the
Acquisition). The results of Laxdale from the date
of acquisition are included in the consolidated profit and loss
account for the Group. Laxdales net liabilities are
consolidated within the consolidated balance sheet at
31 December 2004 and at 31 December 2005.
The acquisition of Laxdale Limited allows Amarin to pursue its
goal of becoming a leader in the research, development and
commercialization of novel drugs for CNS disorders. Vertically
integrating its development partner, improves the economics for
Amarin by reducing royalties payable outside the Group, expands
the territories in which Amarin can commercialize the underlying
product from the US to include Europe and Japan and gives Amarin
direct control over the development of products from the
intellectual property rights acquired.
As consideration for the acquisition of 100% of the outstanding
shares of Laxdale, Amarin issued 3.5 million shares of
Amarins common stock valued at approximately
$3.8 million. Amarin also incurred an estimated
F-12
$0.8 million in transaction fees, including legal, due
diligence and accounting fees. The transaction has been
accounted for as a purchase business combination using
acquisition accounting, and the net preliminary purchase price
of approximately $4.6 million has been allocated to the
tangible and identifiable intangible assets acquired and
liabilities assumed on the basis of their estimated fair values
on the acquisition date.
Preliminary
purchase price
The fair value of each of the Amarin ordinary shares issued of
$1.08 was based on the closing market price of Amarin ADRs on
October 8, 2004, the announcement date of the acquisition.
The estimated total purchase price for the acquisition of 100%
of the outstanding shares of Laxdale is as follows:
|
|
|
|
|
|
|
$000
|
|
|
Fair value of Amarin ordinary
shares issued
|
|
|
3,780
|
|
Direct acquisition costs
|
|
|
813
|
|
|
|
|
|
|
Total purchase price
|
|
|
4,593
|
|
|
|
|
|
|
The final purchase price was dependent on the final direct
acquisition costs together with the contingent consideration
which may become payable, in the future, on the achievement of
certain approval milestones. Further consideration may become
payable upon marketing approval being obtained for approval of
products (covered by Laxdales intellectual property) by
the US Food and Drug Administration (FDA) and
European Medicines Agency (EMEA) approval. The first
approval obtained in the US and Europe would result in
additional consideration of £7,500,000 payable
(approximately $14,500,000 at 2004 year end exchange rates)
for each approval to the vendors of Laxdale Limited. The second
approval obtained in the US and Europe would result in
additional consideration of £5,000,000 payable
(approximately $9,600,000 at 2004 year end exchange rates)
for each approval, to the vendors of Laxdale Limited. Such
additional consideration may be paid in cash or shares at the
sole option of each of the vendors (see note 34) and
would increase the carrying value of the intangible fixed assets
and result in an increased amortization charge over the
remaining useful economic life of these assets.
Fair
value table
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Laxdale
|
|
|
|
|
|
Total
|
|
|
|
book
|
|
|
Total
|
|
|
fair
|
|
|
|
value
|
|
|
adjustments
|
|
|
value
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Intangible fixed assets
|
|
|
|
|
|
|
6,858
|
|
|
|
6,858
|
|
Tangible fixed assets
|
|
|
218
|
|
|
|
|
|
|
|
218
|
|
Investments
|
|
|
282
|
|
|
|
(65
|
)
|
|
|
217
|
|
Debtors
|
|
|
1,059
|
|
|
|
|
|
|
|
1,059
|
|
Cash and overdrafts
|
|
|
(882
|
)
|
|
|
|
|
|
|
(882
|
)
|
Creditors
|
|
|
(2,877
|
)
|
|
|
|
|
|
|
(2,877
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (liabilities)/assets acquired
|
|
|
(2,200
|
)
|
|
|
6,793
|
|
|
|
4,593
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consideration
|
|
No. of Shares
(000)
|
|
|
$
|
|
|
|
|
|
shares issued at fair
value (market value)
|
|
|
3,500
|
|
|
|
1.08
|
|
|
|
3,780
|
|
Other costs of
acquisition
|
|
|
|
|
|
|
|
|
|
|
813
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Laxdale book values on acquisition were derived from audited
management accounts, prepared in pounds sterling and translated
into US dollars at the acquisition date exchange rate. Included
in creditors were amounts loaned of $1,858,000, which together
with the overdraft of $882,000 gave rise to $2,740,000 net
overdrafts and loans acquired by the Group on the acquisition.
F-13
Fair value adjustments were considered for all
assets/liabilities present on Laxdales balance sheet at
the date of acquisition (8 October 2004). For asset classes
other than intangible fixed assets and investments, no fair
value adjustments were made by the directors due to materiality
and specifically, the ongoing use of certain items such as
tangible fixed assets and the proximity to settlement for the
other current assets and liabilities. Other pre-acquisition
additional liabilities were considered by the directors but none
were noted as they did not meet the FRS 7 definitions in that
there were no demonstrable commitments that would happen
irrespective of the acquisition being consummated or not.
Accordingly no provisions for reorganization and restructuring
costs have been included in the fair value of assets and
liabilities acquired.
The most significant fair value (revaluation) adjustment was the
recognition of an intangible asset, representing intellectual
property rights. The recognition criteria for intangible assets
of separability (can be disposed of separately from the company
as a whole) and control (either via custody or legal/contractual
rights) are met, as is the definition of an asset, being the
right to future economic benefits. Measurement of the intangible
asset was achieved by discounted cashflow analysis resulting in
a valuation which was then capped such that negative goodwill
did not arise. This gave rise to the recognition of an
intangible asset, representing intellectual property rights of
$6,858,000.
Laxdale has a shareholding in Amarin (see note 32). The
fair value (revaluation) adjustment to investments, of $65,000,
wrote down the value of these shares from that held within
Laxdales financial statements to the market value at
8 October 2004. This value was $1.08 per share.
Laxdales last accounting reference date prior to its
acquisition was for the year ended 31 March 2004. Details
are provided below for Laxdales results, under UK GAAP,
for the year ended 31 March 2004 and for the
pre-acquisition period of 1 April 2004 to 8 October
2004.
|
|
|
|
|
|
|
|
|
|
|
Period 1 April
|
|
|
|
|
|
|
2004 to
|
|
|
Year ended
|
|
|
|
8 October
|
|
|
31 March
|
|
|
|
2004
|
|
|
2004
|
|
|
|
$000
|
|
|
$000
|
|
|
Income from licensing
|
|
|
|
|
|
|
3,054
|
|
Research & development
|
|
|
(538
|
)
|
|
|
(3,045
|
)
|
Other operating costs
|
|
|
(1,839
|
)
|
|
|
(3,114
|
)
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
|
(2,377
|
)
|
|
|
(3,105
|
)
|
Interest receivable and similar
income
|
|
|
|
|
|
|
20
|
|
Interest payable and similar
charges
|
|
|
(52
|
)
|
|
|
(1
|
)
|
|
|
|
|
|
|
|
|
|
Loss on ordinary activities before
tax
|
|
|
(2,429
|
)
|
|
|
(3,086
|
)
|
Taxation
|
|
|
188
|
|
|
|
399
|
|
|
|
|
|
|
|
|
|
|
Loss for the period transferred to
reserves
|
|
|
(2,241
|
)
|
|
|
(2,687
|
)
|
|
|
|
|
|
|
|
|
|
All recognized gains and losses are included within
Laxdales profit and loss account above.
Laxdale prepares its accounts in sterling; these have been
translated into US dollars using the average rates for the
periods stated above.
F-14
|
|
4.
|
Reporting
financial performance and analysis of exceptional
items
|
The following three tables show the Groups activities, for
each of 2005, 2004 and 2003 analysed into continuing and
discontinued activities. Continuing activities is further
analysed into existing activities and acquisitions for 2004 and
2003.
|
|
|
|
|
|
|
Continuing
|
|
|
|
activities - total
|
|
2005 analysis of
activities
|
|
2005
|
|
|
|
$000
|
|
|
Revenue:
|
|
|
|
|
Licensing & development
fees
|
|
|
500
|
|
|
|
|
|
|
Total revenue
|
|
|
500
|
|
Total gross profit
|
|
|
500
|
|
Net operating
expenses:
|
|
|
|
|
Research & development
|
|
|
8,314
|
|
Selling, general &
administrative
|
|
|
9,767
|
|
Amortization of intangible assets
|
|
|
675
|
|
Reorganization costs
|
|
|
652
|
|
|
|
|
|
|
Total net operating expenses
|
|
|
19,408
|
|
|
|
|
|
|
Total selling, general &
administrative
|
|
|
11,094
|
|
Total research &
development
|
|
|
8,314
|
|
|
|
|
|
|
Total operating
expenses
|
|
|
19,408
|
|
|
|
|
|
|
Operating (loss)
|
|
|
(18,908
|
)
|
|
|
|
|
|
Revenue in total relates to licensing fees received by Amarin,
associated with the licensing of exclusive worldwide rights for
the treatment of fatigue in patients suffering from multiple
sclerosis to Multicell Technologies Inc.
Included in research and development expenses is $2,000 relating
to grant income.
F-15
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing
|
|
|
Continuing
|
|
|
|
|
|
|
|
|
|
|
|
|
activities -
|
|
|
activities -
|
|
|
Continuing
|
|
|
Discontinued
|
|
|
Total
|
|
|
|
existing
|
|
|
acquisition
|
|
|
activities - total
|
|
|
activities
|
|
|
activities
|
|
2004 analysis of
activities
|
|
2004
|
|
|
2004
|
|
|
2004
|
|
|
2004
|
|
|
2004
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales & royalties
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,017
|
|
|
|
1,017
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,017
|
|
|
|
1,017
|
|
Total cost of
sales direct costs
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
107
|
|
|
|
107
|
|
Total gross profit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
910
|
|
|
|
910
|
|
Operating
expenses/(income):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research & development
|
|
|
|
|
|
|
981
|
|
|
|
981
|
|
|
|
2,500
|
|
|
|
3,481
|
|
Selling, general &
administrative
|
|
|
6,399
|
|
|
|
1,057
|
|
|
|
7,456
|
|
|
|
1,575
|
|
|
|
9,031
|
|
Amortization of intangible assets
|
|
|
497
|
|
|
|
102
|
|
|
|
599
|
|
|
|
|
|
|
|
599
|
|
Non recurring payment
|
|
|
|
|
|
|
891
|
|
|
|
891
|
|
|
|
|
|
|
|
891
|
|
Other
income Valeant settlement
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,000
|
)
|
|
|
(2,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
6,896
|
|
|
|
3,031
|
|
|
|
9,927
|
|
|
|
2,075
|
|
|
|
12,002
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total selling, general &
administrative
|
|
|
6,896
|
|
|
|
2,050
|
|
|
|
8,946
|
|
|
|
1,575
|
|
|
|
10,521
|
|
Total research &
development
|
|
|
|
|
|
|
981
|
|
|
|
981
|
|
|
|
2,500
|
|
|
|
3,481
|
|
Other
income Valeant settlement
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,000
|
)
|
|
|
(2,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
|
6,896
|
|
|
|
3,031
|
|
|
|
9,927
|
|
|
|
2,075
|
|
|
|
12,002
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating (loss)
|
|
|
(6,896
|
)
|
|
|
(3,031
|
)
|
|
|
(9,927
|
)
|
|
|
(1,165
|
)
|
|
|
(11,092
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Discontinued revenue included $91,000 related to royalties
received by Amarin, associated with the intangible product
rights sold to Valeant. $926,000 related to product sales and
royalties from API.
F-16
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing
|
|
|
Continuing
|
|
|
Continuing
|
|
|
|
|
|
|
|
|
|
activities -
|
|
|
activities -
|
|
|
activities -
|
|
|
Discontinued
|
|
|
|
|
|
|
existing
|
|
|
acquisition
|
|
|
total
|
|
|
activities
|
|
|
Total
|
|
2003 analysis of
activities
|
|
2003
|
|
|
2003
|
|
|
2003
|
|
|
2003
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing & development
fees
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,715
|
|
|
|
1,715
|
|
Product sales & royalties
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,650
|
|
|
|
5,650
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,365
|
|
|
|
7,365
|
|
Total cost of
sales direct costs
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,912
|
|
|
|
11,912
|
|
Total gross profit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,547
|
)
|
|
|
(4,547
|
)
|
Operating
expenses/(income):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research & development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,442
|
|
|
|
5,442
|
|
Selling, general &
administrative
|
|
|
5,624
|
|
|
|
|
|
|
|
5,624
|
|
|
|
15,147
|
|
|
|
20,771
|
|
Amortization of intangible assets
|
|
|
576
|
|
|
|
|
|
|
|
576
|
|
|
|
4,890
|
|
|
|
5,466
|
|
Gain on renegotiation of Elan debt
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(7,500
|
)
|
|
|
(7,500
|
)
|
Impairment charges
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,095
|
|
|
|
10,095
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
6,200
|
|
|
|
|
|
|
|
6,200
|
|
|
|
28,074
|
|
|
|
34,274
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total selling, general &
administrative
|
|
|
6,200
|
|
|
|
|
|
|
|
6,200
|
|
|
|
22,632
|
|
|
|
28,832
|
|
Total research &
development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,442
|
|
|
|
5,442
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
|
6,200
|
|
|
|
|
|
|
|
6,200
|
|
|
|
28,074
|
|
|
|
34,274
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating (loss)
|
|
|
(6,200
|
)
|
|
|
|
|
|
|
(6,200
|
)
|
|
|
(32,621
|
)
|
|
|
(38,821
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-17
Summary
extraction of exceptional items
Exceptional items which are included within operating expenses
are extracted and explained below.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Turnover
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Discontinued operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(10,624
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Discontinued operations
|
|
|
7
|
|
|
|
|
|
|
|
|
|
|
|
(4,680
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses discontinued operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Administrative
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain on renegotiation of related
party liability
|
|
|
8,25,41
|
|
|
|
|
|
|
|
|
|
|
|
7,500
|
|
Impairment of Primary Care
Portfolio carrying value
|
|
|
8,19
|
|
|
|
|
|
|
|
|
|
|
|
(695
|
)
|
Impairment of Permax carrying value
|
|
|
8,19
|
|
|
|
|
|
|
|
|
|
|
|
(9,400
|
)
|
Other
income Valeant settlement
|
|
|
|
|
|
|
|
|
|
|
2,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,000
|
|
|
|
(2,595
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses continuing operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Administrative
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non recurring payment
|
|
|
|
|
|
|
|
|
|
|
(891
|
)
|
|
|
|
|
Redundancy
|
|
|
6
|
|
|
|
441
|
|
|
|
|
|
|
|
|
|
Property
|
|
|
6
|
|
|
|
187
|
|
|
|
|
|
|
|
|
|
Other
|
|
|
6
|
|
|
|
24
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
652
|
|
|
|
1,109
|
|
|
|
(2,595
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
On 25 February 2004, Amarin sold its US business to Valeant
Pharmaceuticals International (Valeant). Subsequent
to the closing of the sale, it became apparent from wholesalers
that they held approximately $6 million of additional
Permax inventory above that known at the time of closing the
sale. Valeant sought to reduce the consideration it paid in
respect of this new information. On 29 September 2004,
Amarin reached a full and final settlement agreement with
Valeant whereby $6,000,000 of $8,000,000 in future contingent
milestones due to Amarin from Valeant were waived. Valeant paid
the remaining $2,000,000 to Amarin on 1 December 2004,
representing an exceptional accounting and cashflow item.
Following the acquisition of Amarin Neuroscience Limited
(formerly known as Laxdale Limited) on 8 October 2004, the
Group paid $891,000 (£500,000) to reduce the royalties
payable to the holders of certain intellectual property from 15%
to 5%, representing an exceptional accounting and cashflow item.
The exceptional charges in 2003 relating to turnover comprise
$9,036,000 of Permax charges relating to returns and sales
deductions, and $1,588,000 relating to returns of primary care
products.
Explanations of the other exceptional items are contained in the
notes referenced in the table above.
F-18
The Group operates in, and is managed as, a single segment. The
majority of discontinued sales were made to companies based in
the United States. The following analysis is of revenue by
geographical segment, by destination and by origin, of net
(loss)/profit and net assets/(liabilities) by companies in each
territory. Analysis is also provided of revenue by class and
also of long-lived assets by geographical location.
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales by destination
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
North
America continuing operations
|
|
|
500
|
|
|
|
|
|
|
|
|
|
North
America discontinued operations
|
|
|
|
|
|
|
1,017
|
|
|
|
2,683
|
|
Europe discontinued
operations
|
|
|
|
|
|
|
|
|
|
|
4,682
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operations
|
|
|
500
|
|
|
|
1,017
|
|
|
|
7,365
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales by origin
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
United
Kingdom continuing operations
|
|
|
500
|
|
|
|
|
|
|
|
|
|
North
America discontinued operations
|
|
|
|
|
|
|
1,017
|
|
|
|
2,683
|
|
Europe discontinued
operations
|
|
|
|
|
|
|
|
|
|
|
4,682
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operations
|
|
|
500
|
|
|
|
1,017
|
|
|
|
7,365
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss)/profit on ordinary
activities before interest
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
United
Kingdom continuing
operations existing
|
|
|
(17,897
|
)
|
|
|
(6,896
|
)
|
|
|
(6,200
|
)
|
United
Kingdom continuing
operations acquisition
|
|
|
|
|
|
|
(3,031
|
)
|
|
|
|
|
North
America discontinued operations
|
|
|
|
|
|
|
20,300
|
|
|
|
(23,637
|
)
|
Europe continuing
operations
|
|
|
(1,011
|
)
|
|
|
|
|
|
|
|
|
Europe discontinued
operations
|
|
|
|
|
|
|
750
|
|
|
|
4,092
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(18,908
|
)
|
|
|
11,123
|
|
|
|
(25,745
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
assets/(liabilities)
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Geographical segment
|
|
|
|
|
|
|
|
|
|
|
|
|
United Kingdom
|
|
|
39,591
|
|
|
|
16,693
|
|
|
|
(10,202
|
)
|
Europe
|
|
|
(1,011
|
)
|
|
|
|
|
|
|
|
|
North America
|
|
|
|
|
|
|
|
|
|
|
3,854
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
38,580
|
|
|
|
16,693
|
|
|
|
(6,348
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales analysis by class of
business
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Licensing and development
fees continuing operations
|
|
|
500
|
|
|
|
|
|
|
|
|
|
Licensing and development
fees discontinued operations
|
|
|
|
|
|
|
91
|
|
|
|
1,697
|
|
Product sales and
royalties discontinued operations
|
|
|
|
|
|
|
926
|
|
|
|
5,668
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operations
|
|
|
500
|
|
|
|
1,017
|
|
|
|
7,365
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-19
|
|
|
|
|
|
|
|
|
|
|
|
|
Long lived assets by
geographical location
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
United Kingdom
|
|
|
10,055
|
|
|
|
10,729
|
|
|
|
32,049
|
|
Europe
|
|
|
32
|
|
|
|
|
|
|
|
|
|
North America
|
|
|
|
|
|
|
|
|
|
|
731
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,087
|
|
|
|
10,729
|
|
|
|
32,780
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Significant
customers
During the years ended 31 December the following
percentages of the Groups revenues were from:
|
|
|
|
|
|
|
|
|
2005
|
|
2004
|
|
2003
|
|
|
%
|
|
%
|
|
%
|
|
Top customer
|
|
100
|
|
|
|
54
|
Next 4 largest
|
|
|
|
|
|
36
|
For 2005, revenue relates to one customer in the United States
of America. For 2004, revenues related to discontinued
activities for which details of significant customers was not
available following the API disposal in February 2004. For 2003,
significant customers were located in the United States of
America.
Operating
costs and assets and liabilities
The majority of operating costs and assets and liabilities serve
the remaining class of business, being research and development.
Therefore it is not possible to analyze profit or loss before
taxation or net assets between classes of business. The
directors do not regard the level of sales between segments of
the business to be significant and as a result these are not
separately classified. Sales between Group companies have been
eliminated on consolidation.
|
|
6.
|
Exceptional
operating expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Redundancy
|
|
|
441
|
|
|
|
|
|
|
|
|
|
Property
|
|
|
187
|
|
|
|
|
|
|
|
|
|
Income from Valeant settlement
|
|
|
|
|
|
|
(2,000
|
)
|
|
|
|
|
Non recurring payment
|
|
|
|
|
|
|
891
|
|
|
|
|
|
Gain on renegotiation of related
party liability
|
|
|
|
|
|
|
|
|
|
|
(7,500
|
)
|
Impairment of Primary Care
Portfolio carrying value
|
|
|
|
|
|
|
|
|
|
|
695
|
|
Impairment of Permax carrying value
|
|
|
|
|
|
|
|
|
|
|
9,400
|
|
Other
|
|
|
24
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
652
|
|
|
|
(1,109
|
)
|
|
|
2,595
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During 2005, the Company recorded reorganization charges to
align the business for maximum efficiency. Amarins
reorganization plan, once completed will result in a reduction
in headcount, the relocation of the research and development
function to the South East of England and the consolidation of
administrative functions in Dublin, Ireland. In determining the
charges to record, the directors made certain estimates and
judgments surrounding the amounts ultimately to be paid for the
actions the Company has taken or is committed to taking. At
December 31, 2005, there are various accruals recorded for
the costs to terminate employees contracts and exit
certain facilities and lease obligations, which may be adjusted
periodically for either resolution of certain contractual
commitments or changes in estimates.
F-20
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Cost of sales
|
|
|
|
|
|
|
|
|
|
|
107
|
|
|
|
7,232
|
|
Exceptional item
|
|
|
4
|
|
|
|
|
|
|
|
|
|
|
|
4,680
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
107
|
|
|
|
11,912
|
|
Analyzed:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Discontinued operations
|
|
|
|
|
|
|
|
|
|
|
107
|
|
|
|
11,912
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cost of sales
|
|
|
|
|
|
|
|
|
|
|
107
|
|
|
|
11,912
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As described in note 11, Amarin sold the majority of its US
operations to Valeant in February 2004.
During 2003, the Company recorded charges of $4,518,000 in
respect of Permax inventory write-offs because of the
deterioration in sales following the launch of a generic
competitor in December 2002. Inventory losses of $762,000 arose
on the primary care line of products. Offsetting these charges
was a $600,000 reduction in Permax royalty relating to the
exceptional reductions in revenues.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Administrative and general expenses
|
|
|
|
|
|
|
9,767
|
|
|
|
8,166
|
|
|
|
11,363
|
|
Gain on renegotiation of related
party liability
|
|
|
25,41
|
|
|
|
|
|
|
|
|
|
|
|
(7,500
|
)
|
Amortization of intangible fixed
assets
|
|
|
19
|
|
|
|
675
|
|
|
|
599
|
|
|
|
5,466
|
|
Impairment of Primary Care
Portfolio carrying value
|
|
|
19
|
|
|
|
|
|
|
|
|
|
|
|
695
|
|
Impairment of Permax carrying value
|
|
|
19
|
|
|
|
|
|
|
|
|
|
|
|
9,400
|
|
Other
income Valeant settlement
|
|
|
38
|
|
|
|
|
|
|
|
(2,000
|
)
|
|
|
|
|
Non recurring payment
|
|
|
4
|
|
|
|
|
|
|
|
891
|
|
|
|
|
|
Reorganization costs
|
|
|
|
|
|
|
652
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total administrative
expenses
|
|
|
|
|
|
|
11,094
|
|
|
|
7,656
|
|
|
|
19,424
|
|
Distribution
costs selling and marketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Discontinued operations
|
|
|
|
|
|
|
|
|
|
|
865
|
|
|
|
9,408
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total selling, administrative and
general
|
|
|
|
|
|
|
11,094
|
|
|
|
8,521
|
|
|
|
28,832
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Analyzed:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing
operations existing operations
|
|
|
|
|
|
|
11,094
|
|
|
|
6,896
|
|
|
|
6,200
|
|
Continuing
operations acquisitions
|
|
|
|
|
|
|
|
|
|
|
2,050
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total continuing operations
|
|
|
|
|
|
|
11,094
|
|
|
|
8,946
|
|
|
|
6,200
|
|
Discontinued operations
|
|
|
|
|
|
|
|
|
|
|
(425
|
)
|
|
|
22,632
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,094
|
|
|
|
8,521
|
|
|
|
28,832
|
|
Research and development
costs
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing operations
|
|
|
|
|
|
|
8,314
|
|
|
|
981
|
|
|
|
|
|
Discontinued operations
|
|
|
|
|
|
|
|
|
|
|
2,500
|
|
|
|
5,442
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
|
|
|
|
|
19,408
|
|
|
|
12,002
|
|
|
|
34,274
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development costs include staff costs, professional
and contractor fees, materials and external services.
F-21
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Aggregate emoluments
|
|
|
|
|
|
|
1,795
|
|
|
|
1,213
|
|
|
|
1,137
|
|
Company pension contributions to
money purchase Schemes
|
|
|
|
|
|
|
136
|
|
|
|
44
|
|
|
|
30
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,931
|
|
|
|
1,257
|
|
|
|
1,167
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company paid or accrued pension contributions to money
purchase pension schemes on behalf of two directors (years to
31 December 2004: two directors; 31 December 2003: one
director).
T G Lynch waived emoluments in respect of the year ended
31 December 2005 amounting to $45,000 (years to
31 December 2004 and 2003: $46,000 and $41,000
respectively). Also, J Groom waived emoluments in respect of the
year ended 31 December 2005 amounting to $45,000 (years to
31 December 2004 and 2003; $46,000 and $41,000
respectively).
Total remuneration of directors (including benefits in kind)
includes amounts paid to:
Highest
paid director
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Aggregate emoluments
|
|
|
830
|
|
|
|
638
|
|
|
|
581
|
|
Company pension contributions to
money purchase Schemes
|
|
|
33
|
|
|
|
33
|
|
|
|
30
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
863
|
|
|
|
671
|
|
|
|
611
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During each of the years ended 31 December 2005, 2004 and
2003, no director exercised options.
The average monthly number of persons (including executive
directors) employed by the Group during the year was:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
Number
|
|
|
Number
|
|
|
Number
|
|
|
Marketing and administration
|
|
|
12
|
|
|
|
15
|
|
|
|
50
|
|
Research and development
|
|
|
11
|
|
|
|
3
|
|
|
|
25
|
|
Computing
|
|
|
|
|
|
|
|
|
|
|
2
|
|
Laboratory
|
|
|
|
|
|
|
|
|
|
|
13
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
23
|
|
|
|
18
|
|
|
|
90
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Staff costs (for the above
persons):
|
|
|
|
|
|
|
|
|
|
|
|
|
Wages and salaries
|
|
|
4,171
|
|
|
|
3,479
|
|
|
|
9,366
|
|
Social security costs
|
|
|
462
|
|
|
|
452
|
|
|
|
1,023
|
|
Other pension costs
|
|
|
244
|
|
|
|
111
|
|
|
|
160
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,877
|
|
|
|
4,042
|
|
|
|
10,549
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At the end of 2005, the Group employed 22 people.
F-22
The average monthly number of persons (including executive
directors) employed by the Company during the year was:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
Number
|
|
|
Number
|
|
|
Number
|
|
|
Marketing and administration
|
|
|
8
|
|
|
|
8
|
|
|
|
9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Staff costs (for the above
persons):
|
|
|
|
|
|
|
|
|
|
|
|
|
Wages and salaries
|
|
|
2,165
|
|
|
|
2,283
|
|
|
|
3,378
|
|
Social security costs
|
|
|
256
|
|
|
|
289
|
|
|
|
372
|
|
Other pension costs
|
|
|
46
|
|
|
|
77
|
|
|
|
80
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,467
|
|
|
|
2,649
|
|
|
|
3,830
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At the end of 2005, the Company employed 5 people.
|
|
11.
|
Profit/(loss)
on disposal of discontinued operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Profit on sale Gacell Holdings AB
and Amarin Development (Sweden) AB
|
|
|
|
|
|
|
750
|
|
|
|
13,076
|
|
Loss on disposal of US operations
and certain products
|
|
|
|
|
|
|
(3,143
|
)
|
|
|
|
|
Gain on settlement of debt on
related sale of distribution rights
|
|
|
|
|
|
|
24,608
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
22,215
|
|
|
|
13,076
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Profit on
disposal of Swedish operations
As disclosed in our 2003 Annual Report and 20-F, during October
2003, Amarin disposed of its Swedish drug delivery and
development business comprising interests in Gacell Holdings AB
and Amarin Development (Sweden) AB. At 31 December 2003,
$750,000 of the gross sale proceeds remained in escrow against
potential claims by the purchaser. This amount was released by
the purchaser to Amarin during 2004.
F-23
The 2003 disposal comprised Gacell Holdings AB and Amarin
Development (Sweden) AB, as follows:
|
|
|
|
|
|
|
$000
|
|
|
Intangible fixed assets
|
|
|
145
|
|
Tangible fixed assets
|
|
|
1,029
|
|
Stock
|
|
|
59
|
|
Debtors
|
|
|
1,501
|
|
Cash
|
|
|
(329
|
)
|
Creditors
|
|
|
(1,506
|
)
|
|
|
|
|
|
|
|
|
899
|
|
Profit on disposal
|
|
|
13,076
|
|
|
|
|
|
|
Consideration net
of expenses and escrow
|
|
|
13,975
|
|
|
|
|
|
|
Gross proceeds
|
|
|
15,000
|
|
Less post closing working capital
adjustment
|
|
|
(150
|
)
|
Less retention for potential claims
|
|
|
(750
|
)
|
Less legal fees
|
|
|
(125
|
)
|
|
|
|
|
|
|
|
|
13,975
|
|
|
|
|
|
|
As at 31 December 2003, $600,000 of the consideration was
outstanding and was included within other debtors. This was
received in 2004. The consolidated profit and loss account of
Gacell and Amarin Development through to the date of disposal,
consolidated in the Group profit and loss account as
discontinued operations was as follows:
|
|
|
|
|
|
|
Year ended 31
|
|
|
|
December
|
|
|
|
2003
|
|
|
|
$000
|
|
|
Turnover
|
|
|
|
|
Royalties and product sales
|
|
|
2,860
|
|
Licensing and development fees
|
|
|
1,697
|
|
Services
|
|
|
19
|
|
|
|
|
|
|
Total turnover from discontinued
operations
|
|
|
4,576
|
|
Cost of sales
|
|
|
(1,254
|
)
|
|
|
|
|
|
Gross profit
|
|
|
3,322
|
|
Operating expenses
|
|
|
|
|
Research and development
|
|
|
(3,731
|
)
|
Selling, general and
administrative expenses
|
|
|
(987
|
)
|
|
|
|
|
|
Total operating expenses from
discontinued operations
|
|
|
(4,718
|
)
|
|
|
|
|
|
Operating (loss) and (loss) from
discontinued operations
|
|
|
(1,396
|
)
|
|
|
|
|
|
Loss on
disposal of US operations and certain products
During February 2004, Amarin sold the majority of its US
operations to Valeant. This sale, which resulted in a loss of
$2.3 million, comprised Amarins
U.S.-based
subsidiary, API, the entirety of its marketed U.S. products
(comprising the primary care portfolio and Permax) and its
rights to the development compound Zelapar.
Additionally, Amarin has an obligation to pay the rent on the
now vacant premises formerly occupied by its US operations (see
note 28). Amarin paid $176,000 in rent during 2004, under
this lease. The value of the remaining obligation, less
managements estimate of future sub-lease income, was
$655,000 at 31 December 2004. This was
F-24
included within provisions for liabilities and charges at
31 December 2004 and included in the loss on disposal. In
prior years, these premises were fully utilized by API and so no
provision arose. In November 2005, Amarin signed an agreement
with the landlord terminating the lease on payment of a $500,000
termination penalty. $300,000 of this penalty was paid in
December 2005. The remaining balance was due within 30 days
of the 22 December 2005 financing (see note 28). The
remaining balance was paid on 19 January 2006. Included in
other creditors within one year is an amount for $200,000 which
relates to the remaining balance.
|
|
|
|
|
|
|
$000
|
|
|
Loss on disposal in February 2004
(see table below)
|
|
|
2,312
|
|
Rent paid during 2004 by Amarin
|
|
|
176
|
|
Estimated obligation less sublease
income
|
|
|
655
|
|
|
|
|
|
|
Total loss on disposal for
2004
|
|
|
3,143
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Book Value
|
|
|
|
$000
|
|
|
Intangible fixed
assets product rights
|
|
|
35,600
|
|
Tangible fixed assets
|
|
|
675
|
|
Stock
|
|
|
3,201
|
|
Cash
|
|
|
1,801
|
|
Creditors
|
|
|
(12,580
|
)
|
|
|
|
|
|
|
|
|
28,697
|
|
Loss on disposal
|
|
|
(2,312
|
)
|
|
|
|
|
|
Consideration net
of expenses
|
|
|
26,385
|
|
|
|
|
|
|
Gross proceeds
|
|
|
38,000
|
|
Less inventory management fees
|
|
|
(9,300
|
)
|
Less legal and transaction fees
|
|
|
(2,315
|
)
|
|
|
|
|
|
Consideration net
of expenses
|
|
|
26,385
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Summary of key cash
inflows/(outflows)
|
|
|
|
|
|
$ million
|
|
|
Proceeds from disposal of
intangible fixed assets
|
|
|
36.4
|
|
|
|
|
|
|
Proceeds on disposal of shares in
API
|
|
|
1.6
|
|
Inventory management fees
|
|
|
(9.3
|
)
|
Legal and transaction fees
|
|
|
(2.3
|
)
|
Mill Valley lease payments
|
|
|
(0.2
|
)
|
|
|
|
|
|
|
|
|
(10.2
|
)
|
|
|
|
|
|
F-25
The profit and loss account of the US business sold to Valeant
Pharmaceuticals International on 25 February 2004 that was
also considered in the Group profit and loss account as
discontinued operations is as follows:
US
Business sold 25 February 2004
|
|
|
|
|
|
|
|
|
|
|
Period ended
|
|
|
Year ended
|
|
|
|
25 February
|
|
|
31 December
|
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
Turnover
|
|
|
|
|
|
|
|
|
Royalties and product sales
|
|
|
926
|
|
|
|
2,683
|
|
|
|
|
|
|
|
|
|
|
Total turnover from discontinued
operations
|
|
|
926
|
|
|
|
2,683
|
|
Cost of sales
|
|
|
(107
|
)
|
|
|
(10,659
|
)
|
|
|
|
|
|
|
|
|
|
Gross profit/(loss)
|
|
|
819
|
|
|
|
(7,976
|
)
|
Operating expenses
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
|
|
|
(1,711
|
)
|
Selling, general and
administrative expenses
|
|
|
(1,575
|
)
|
|
|
(13,950
|
)
|
|
|
|
|
|
|
|
|
|
Total operating expenses from
discontinued operations
|
|
|
(1,575
|
)
|
|
|
(15,661
|
)
|
|
|
|
|
|
|
|
|
|
Operating (loss) and (loss) from
discontinued operations
|
|
|
(756
|
)
|
|
|
(23,637
|
)
|
|
|
|
|
|
|
|
|
|
Gain on
settlement of debt on related sale of distribution
rights
In February 2004, upon closing the sale of the US operations and
certain product rights to Valeant Pharmaceuticals International,
Amarin settled its debt obligations with Elan through a cash
payment of $17.195 million (part of which represented the
cost of acquiring
Zelapartm
that was concurrently sold to Valeant), issuing a new
$5 million
5-year loan
note and issuing 500,000 warrants over ordinary shares. An
additional $1 million was paid to Elan in November 2004,
following the settlement of the dispute with Valeant. Details of
the Elan debt settlement are explained more fully in the
creditors notes 25 and 26, major non-cash
transactions note 38 and the related party note 41.
The settlement with Elan resulted in a gain of
$24.6 million.
|
|
12.
|
Interest
receivable and similar income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Bank interest receivable and
similar income
|
|
|
394
|
|
|
|
105
|
|
|
|
65
|
|
Other interest receivable
|
|
|
1
|
|
|
|
34
|
|
|
|
|
|
Foreign exchange gain and related
income
|
|
|
|
|
|
|
409
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
395
|
|
|
|
548
|
|
|
|
65
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December 2004, the foreign exchange gain arises on
the translation of cash balances in Amarin Corporation plc.
|
|
13.
|
Interest
payable and similar charges
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
On bank overdrafts
|
|
|
|
|
|
|
6
|
|
|
|
3
|
|
On other loans
|
|
|
62
|
|
|
|
283
|
|
|
|
866
|
|
On finance leases
|
|
|
3
|
|
|
|
|
|
|
|
31
|
|
Foreign exchange loss
|
|
|
827
|
|
|
|
37
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
892
|
|
|
|
326
|
|
|
|
900
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-26
At 31 December 2005, the foreign exchange loss arises on the
translation of euro and sterling cash and overdraft balances
into US dollars on the consolidation of Amarin Corporation plc
and Amarin Neuroscience Limited using the temporal method. At
31 December 2004, the foreign exchange loss arises on the
translation of cash and overdraft balances on the consolidation
of Amarin Neuroscience Limited using the temporal method.
|
|
14.
|
(Loss)/profit
on ordinary activities before taxation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
(Loss)/profit on ordinary
activities before taxation is stated after
charging/(crediting):
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation/amortization charge
for the period:
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible fixed assets
|
|
|
675
|
|
|
|
599
|
|
|
|
5,466
|
|
Tangible owned fixed assets
|
|
|
127
|
|
|
|
155
|
|
|
|
417
|
|
Tangible fixed assets held under
finance leases
|
|
|
8
|
|
|
|
|
|
|
|
134
|
|
Auditors remuneration for
audit of Group
|
|
|
|
|
|
|
|
|
|
|
|
|
Statutory audit services
|
|
|
230
|
|
|
|
251
|
|
|
|
157
|
|
Further assurance services
|
|
|
175
|
|
|
|
249
|
|
|
|
255
|
|
Auditors remuneration for
non-audit work
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax services
|
|
|
|
|
|
|
|
|
|
|
|
|
Compliance services
|
|
|
16
|
|
|
|
41
|
|
|
|
25
|
|
Advisory services
|
|
|
90
|
|
|
|
63
|
|
|
|
90
|
|
Operating lease charges
|
|
|
|
|
|
|
|
|
|
|
|
|
Plant and machinery
|
|
|
51
|
|
|
|
43
|
|
|
|
85
|
|
Other
|
|
|
886
|
|
|
|
1,091
|
|
|
|
1,174
|
|
Foreign exchange difference
arising on retranslation of net investment in subsidiaries
|
|
|
(939
|
)
|
|
|
302
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Auditors remuneration in relation to the statutory audit
of the Company is estimated to be $195,000 for the year ended
31 December 2005 ($183,000 and $157,000 for the years ended
31 December 2004 and 2003 respectively).
In order to maintain the independence of the external auditors,
the Board has determined policies as to what non-audit services
can be provided by the companys external auditors and the
approval processes related to them. Under these policies the
Board has agreed that the external auditors should be excluded
from providing management, strategic, IT consultancy and all
other non-audit and non-tax related services, unless the firm
appointed as external auditor is:
|
|
|
|
|
the only provider of the specific expertise/service
required: or
|
|
|
|
the clear leader in the provision of the service on a
competitively priced basis.
|
As auditors, PricewaterhouseCoopers LLP will undertake work that
they are best placed to complete.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Tax on (loss)/profit on ordinary
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
United Kingdom corporation tax at
30%: current year
|
|
|
(698
|
)
|
|
|
(167
|
)
|
|
|
|
|
Overseas taxation: current year
|
|
|
|
|
|
|
|
|
|
|
144
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current tax (credit)/charge
|
|
|
(698
|
)
|
|
|
(167
|
)
|
|
|
144
|
|
Deferred tax charge/(credit)
|
|
|
|
|
|
|
7,500
|
|
|
|
(7,500
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total tax (credit)/charge
|
|
|
(698
|
)
|
|
|
7,333
|
|
|
|
(7,356
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-27
The following items represent the principal reasons for the
differences between corporate income taxes computed at the
United Kingdom statutory tax rate and the total current tax
charge for the year.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
(Loss)/profit on ordinary
activities before tax
|
|
|
(19,405
|
)
|
|
|
11,345
|
|
|
|
(26,580
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss)/profit on ordinary
activities multiplied by standard rate of corporate tax in the
UK of 30%
|
|
|
(5,822
|
)
|
|
|
3,404
|
|
|
|
(7,974
|
)
|
Overseas tax and adjustments in
respect of foreign tax rates
|
|
|
35
|
|
|
|
|
|
|
|
35
|
|
Accelerated capital allowances and
other timing differences
|
|
|
4,969
|
|
|
|
(3,701
|
)
|
|
|
14,847
|
|
Research and development tax
credit relief
|
|
|
559
|
|
|
|
40
|
|
|
|
|
|
Expenses not deductible for tax
purposes
|
|
|
(439
|
)
|
|
|
90
|
|
|
|
(6,764
|
)
|
Adjustments to tax charge in
respect of previous period
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current tax (credit)/charge
|
|
|
(698
|
)
|
|
|
(167
|
)
|
|
|
144
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In the UK, the applicable statutory rate for Corporate income
tax was 30% for the years ended 31 December 2003, 2004 and
2005.
The corporate tax rate in Ireland is 12.5% for profits on
trading activities and 25% for non-trading activities.
Losses carried forward in Amarin Corporation plc at
31 December 2005 were $39,848,000 (31 December 2004:
$31,715,000, 31 December 2003: $41,690,000) subject to
confirmation by UK tax authorities. Under UK tax law, these
losses can be carried forward indefinitely for set off against
future profits of the same trade. Losses carried forward in
Amarin Neuroscience Limited at 31 December 2005 were
$21,412,000 (31 December 2004: $14,451,000) subject to
confirmation by UK tax authorities. The disposal of ADAB in 2003
and API in 2004 has had no impact on the carry forward of tax
losses, or on the deferred tax assets. The acquisition of
Laxdale during 2004 increased the group tax losses carried
forward by £13,837,000 and the unrecognized deferred tax
asset by £4,378,000.
Losses carried forward in Amarin Pharmaceuticals Ireland Limited
at 31 December 2005 were $680,000 subject to confirmation
by Irish tax authorities.
Deferred
tax (Group and Company)
The deferred tax asset provided in the financial statements is
as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Accelerated capital allowances
|
|
|
|
|
|
|
|
|
|
|
5,700
|
|
Short term timing differences
|
|
|
|
|
|
|
|
|
|
|
1,800
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,500
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$000
|
|
|
Deferred tax provided at
1 January 2003
|
|
|
|
|
Deferred tax credited to profit
and loss account
|
|
|
(7,500
|
)
|
|
|
|
|
|
At 31 December 2003 and
1 January 2004
|
|
|
(7,500
|
)
|
Deferred tax charged to profit and
loss account
|
|
|
7,500
|
|
|
|
|
|
|
At 31 December 2004,
1 January 2005 and 31 December 2005
|
|
|
|
|
|
|
|
|
|
A deferred tax asset of $7,500,000 was accounted for by the
Company and the Group in 2003 as the Company utilized timing
differences, that reversed in 2004 against a gain on the
settlement of Elan debt.
F-28
The Group has potential deferred tax asset as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Accelerated capital allowances
|
|
|
(19,249
|
)
|
|
|
(19,199
|
)
|
|
|
(12,237
|
)
|
Short term timing differences
|
|
|
(3
|
)
|
|
|
(4
|
)
|
|
|
(557
|
)
|
Losses
|
|
|
(18,701
|
)
|
|
|
(13,666
|
)
|
|
|
(12,507
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(37,953
|
)
|
|
|
(32,869
|
)
|
|
|
(25,301
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In 2005, 2004 and 2003 high levels of corporate tax losses
carried forward and insufficient certainty of future
profitability resulted in unrecognized potential deferred tax
assets of $37,953,000, $32,869,000 and $25,301,000 respectively.
The deferred tax asset of $18,701,000 in respect of losses
includes $153,000 of capital loss that can only be utilised
against future capital gains.
During the years ended 31 December 2005, 2004 and 2003 the
reconciling items in arriving at the current tax charge related
to accelerated capital allowances, other short term timing
differences, losses carried forward and expenses not deductible
for tax purposes. The main timing difference related to losses
that were carried forward for set off against future profits of
the same trade. In 2003, the credit shown in expenses not
deductible for tax purposes principally related to the gain on
the disposal of ADAB, which is covered by substantial
shareholding relief.
No tax liability arose on the disposal of Amarin Pharmaceutical
Inc or Amarin Development (Sweden) AB.
|
|
16.
|
(Loss)/profit
for the financial period
|
As permitted by section 230 of the Companies Act 1985, the
Companys profit and loss account has not been included in
these financial statements. Of the consolidated loss
attributable to the shareholders of Amarin Corporation plc a
loss of $9,163,000 (31 December 2004: profit of $5,482,000,
31 December 2003: loss of $31,254,000) has been dealt with
in the financial statements of the Company.
|
|
17.
|
(Loss)/profit
per ordinary share
|
The (loss)/profit per ordinary share is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
(Loss)/profit for the financial
year
|
|
|
(18,707
|
)
|
|
|
4,012
|
|
|
|
(19,224
|
)
|
Dividends
credit/(payable) non-equity
|
|
|
|
|
|
|
643
|
|
|
|
(24
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss)/profit attributable to
ordinary shareholders
|
|
|
(18,707
|
)
|
|
|
4,655
|
|
|
|
(19,248
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
US cents
|
|
|
US cents
|
|
|
US cents
|
|
|
Basic (loss)/profit per ordinary
share
|
|
|
(40.0
|
)
|
|
|
20.7
|
|
|
|
(112.6
|
)
|
Fully diluted (loss)/profit per
ordinary share
|
|
|
(40.0
|
)
|
|
|
20.7
|
|
|
|
(112.6
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number
|
|
|
Number
|
|
|
Number
|
|
|
Weighted average number of
ordinary shares in issue
|
|
|
46,590,299
|
|
|
|
22,510,767
|
|
|
|
17,093,400
|
|
Dilutive impact of share options
outstanding
|
|
|
|
|
|
|
|
|
|
|
3,900
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fully diluted average number of
ordinary shares in issue
|
|
|
46,590,299
|
|
|
|
22,510,767
|
|
|
|
17,097,300
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic (loss)/profit per share is calculated by dividing the
(loss)/profit attributable to ordinary shareholders by the
weighted average number of ordinary shares in issue in the year.
The (loss)/profit attributable to ordinary shareholders is the
(loss)/profit remaining after non-equity dividends. In 2005,
200,797 (2004: 46,633) shares have been deducted in arriving at
the weighted average number of ordinary shares in issue, being
the weighted average number of treasury shares for the year.
F-29
Fully diluted (loss)/profit per share is calculated using the
weighted average number of ordinary shares in issue adjusted to
reflect the effect were the cumulative preference shares to be
converted to additional ordinary shares, together with the
effect of exercising those share options granted where the
exercise price is less than the average market price of the
ordinary shares during the year. For the purposes of calculating
the fully diluted (loss)/profit per share, the potential
dilution has not been assessed with regard to the future
investment rights (see note 30). The Company reported a net
loss from continuing operations in 2005, 2004 and 2003. As a
result the loss per share is not reduced by dilution or the
future investment right (see note 30).
|
|
18.
|
Dividends non-equity
|
During 2003, the last remaining 2,000,000 3% convertible
preference shares, held by Elan, were converted into ordinary
shares and non-equity dividends of $24,000 were accrued. On
conversion, Elan gave up their preferential rights, including
any rights to an accrued dividend, in exchange for the new
ordinary shares allocated. In February 2004, Amarin settled its
debt obligations with Elan by the payment of cash and the issue
of a $5 million loan note. As a result, with there being no
longer a need to maintain an accrual for a preference dividend
in 2004, Amarin released the accrued preference share dividends
of $643,000.
|
|
19.
|
Intangible
fixed assets
|
|
|
|
|
|
|
|
Product rights
|
|
|
|
$000
|
|
|
Group
|
|
|
|
|
Cost
|
|
|
|
|
At 1 January 2003
|
|
|
118,988
|
|
Disposal
|
|
|
(234
|
)
|
|
|
|
|
|
At 31 December 2003 and
1 January 2004
|
|
|
118,754
|
|
Additions
|
|
|
7,894
|
|
Acquisitions
|
|
|
6,858
|
|
Disposals
|
|
|
(120,434
|
)
|
|
|
|
|
|
At 31 December 2004,
1 January 2005, and 31 December 2005
|
|
|
13,072
|
|
|
|
|
|
|
Amortization
|
|
|
|
|
At 1 January 2003
|
|
|
71,533
|
|
Charge for the year
|
|
|
5,466
|
|
Eliminated on disposal
|
|
|
(89
|
)
|
Impairment charge
|
|
|
10,095
|
|
|
|
|
|
|
At 31 December 2003 and at
1 January 2004
|
|
|
87,005
|
|
Charge for the year
|
|
|
599
|
|
Eliminated on disposal
|
|
|
(84,834
|
)
|
|
|
|
|
|
At 31 December 2004 and at
1 January 2005
|
|
|
2,770
|
|
Charge for the year
|
|
|
675
|
|
|
|
|
|
|
At 31 December
2005
|
|
|
3,445
|
|
|
|
|
|
|
Net Book Value
|
|
|
|
|
Net book value at
31 December 2005
|
|
|
9,627
|
|
|
|
|
|
|
Net book value at 31 December
2004
|
|
|
10,302
|
|
|
|
|
|
|
Net book value at 31 December
2003
|
|
|
31,749
|
|
|
|
|
|
|
During February 2004, Amarin exercised its purchase option to
acquire exclusive US rights to Zelapar (see below for more
information) at a cost of $7,894,000. Amarin then sold Zelapar,
together with Permax and the
F-30
Primary Care Portfolio, to Valeant. As disclosed in the table
above, the total book cost of these disposals was $120,434,000
as detailed below:
|
|
|
|
|
|
|
$000
|
|
|
Permax
|
|
|
93,505
|
|
Primary care portfolio
|
|
|
18,929
|
|
Zelapar
|
|
|
8,000
|
|
|
|
|
|
|
|
|
|
120,434
|
|
|
|
|
|
|
During October 2004, Amarin concluded the acquisition of
Laxdale; see note 3 for details of the fair value of assets
acquired. The acquisition gave rise to the recognition of an
intangible fixed asset, representing intellectual property
rights, relating to Miraxion (formerly known as Lax-101) and
other intellectual property valued at $6,858,000.
This was supported by a discounted cashflow model of future
expected cash outflows, to complete the Miraxion phase III
clinical trials for Huntingtons disease through to
regulatory approvals in the US and Europe together with
contingent consideration milestones payable to the Laxdale
vendors on regulatory approval. Also considered were costs
associated with bringing Miraxion and its indications to market
and future income cashflows from the commercialization of these
indications. The valuation from the model was capped to ensure
negative goodwill did not arise (see note 3).
Amarin estimates that Miraxions first indication, for
Huntingtons disease, will reach approval in late 2007 and
subsequent launch by late 2007 or early 2008, subject to the
time it takes to complete the ongoing phase III clinical
trials and the response time from regulatory authorities. As is
customary with any project, a delay in reaching key milestones
will impact on Amarins cashflows and may result in Amarin
reviewing its funding strategy. The model was adjusted for
various risk factors such as approval and commercial execution
risk.
Summary of
key indications within the pipeline
|
|
|
|
|
|
|
Program
|
|
Indication
|
|
Status
|
|
Partners
|
|
Lipophilic
Platform
|
|
|
|
|
|
|
Miraxion
|
|
Huntingtons disease
|
|
Phase III
|
|
Scil Biomedical GmbH (Germany,
Austria, France, Benelux)
Juste S.A.Q.F. (Spain, Portugal)
Link Pharmaceuticals Ltd (UK, Ireland)
|
Miraxion
|
|
Depressive disorders
|
|
Phase II
|
|
Partner discussions on-going
|
Miraxion
|
|
Parkinsons disease
|
|
Pre-clinical
|
|
|
Combinatorial Lipid
Platform
|
|
|
|
|
|
|
Various
|
|
CNS disorders
|
|
Pre-clinical
|
|
|
LAX-200 Series
|
|
|
|
|
|
|
LAX-201
|
|
Major Depression in Women
|
|
Phase II
|
|
Seeking partner
|
|
|
|
|
|
|
|
MCT-125
|
|
Multiple Sclerosis Fatigue
|
|
Phase II
|
|
Multicell Technologies, Inc.
(worldwide)
|
Additionally, we have assumed from Amarin Neuroscience a license
agreement with a license to 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 Huntingtons disease, depression,
schizophrenia, dementia and other CNS indications.
Amarin is seeking a development and marketing partner for
Miraxion in depression.
F-31
Historical
movement on intangible fixed assets
During November 2000, Amarin acquired limited rights to
Miraxion. On the date of acquiring Laxdale in 2004, the
pre-existing intangible fixed asset had a net book value of
approximately $3,611,000. The useful economic life remaining for
this intangible fixed asset and the intangible acquired on
purchase of Laxdale was determined as 15.5 years
representing the time to patent expiry. The effect of this
revision was a decrease in the amortization charge for the year
of $79,000 on the intangible fixed asset purchased in November
2000.
On May 17, 2001, the Group entered into an agreement with
Elan to license US rights to Permax, a dopamine agonist marketed
for the treatment of Parkinsons disease. Under this
agreement, the Group acquired limited exclusive US distribution,
sales and marketing rights for an initial period of time,
together with a fixed price option to acquire unrestricted US
rights. The initial period of exclusive distribution rights
expired the earlier of 12 months from the date of the
agreement or upon closing of the exercise of the purchase option
to acquire all of Elans US rights to Permax. The exercise
of the option expanded the Groups rights to Permax in a
number of ways, including (1) removing the limited duration
of distribution, sales and marketing rights, (2) providing
the Group with the rights to develop Permax further (e.g. new
formulations) and (3) enabling the Group to sell some or
all of its rights to a third party at some future date.
In 2001, the Group paid Elan $47,500,000 (approximately
£32,348,000) in consideration for the combination of these
rights. A further $37,500,000 (approximately £25,733,000)
would become payable on the exercise of the option. The Group
capitalized the consideration paid to Elan in 2001 as two
separate intangible assets: (1) an exclusive US
distribution right ($29,284,000) and (2) an option to
acquire US rights to Permax ($18,216,000). The initial payment
of $47,500,000 was allocated between the two assets. The value
ascribed to the distribution right was determined using the
present value of projected cash flows anticipated over the
12 month period of the distribution agreement. The balance
of the initial payment was allocated to the option. Prior to the
exercise of the option, the value attributed to the distribution
right was being amortized over its 12 month term. The value
attributed to the option was not amortized as this amount
represents a component of purchase consideration, subject to any
impairment.
In 2002, the Group exercised its option to acquire Elans
entire US Permax rights, triggering the further consideration of
$37,500,000 (approximately £25,733,000). The Permax asset
was recorded at an amount equal to the total consideration paid,
which included both the $37,500,000 in payments arising from the
exercise of the option in 2002, as well as the $18,216,000 in
value attributed to the option originally in 2001. In addition,
with the exercise of the option, management reassessed the
useful life of the distribution right and concluded that the
remaining carrying amount of $12,060,000 (being the original
$29,284,000 cost amortized up to the date the option was deemed
to have been exercised January 1,
2002) should be amortized over a remaining period of
14 years to match the life assigned to the Permax
intangible acquired in March 2002.
On 1 January 2003, the Groups functional and
reporting currency was changed to US dollars from pounds
sterling. Comparative data, which was historically reported in
pounds sterling, was recalculated as if converted to US dollars
at the 31 December 2002 closing exchange rate of $1.6099 to
£1. Accordingly, the combined Permax intangibles had a
carrying cost value of £58,081,000 which was converted to
$93,505,000 and the Zelapar intangible had a carrying value of
£66,000 which was converted to $106,000.
During 2002, the Group recorded an impairment charge in relation
to the value of Permax ($38,357,000) based on value in use,
following the introduction of generic competition. The
impairment charge was calculated in accordance with FRS11 (UK
GAAP) Impairment of fixed assets and goodwill using
discounted expected future cashflows at an appropriate risk
adjusted rate. As prescribed in FRS11 the launch of a generic is
a trigger event which necessitates, where
appropriate, a revision of the carrying value of the intangible.
Subsequent to this impairment charge, the Permax estimated
economic useful life was reduced to 10 years, the estimated
economic useful life of the other product rights.
The Group reviewed the 2003 year end carrying value of
Permax and the Primary Care Portfolio for possible impairment by
comparing the net realizable amounts resulting from the sale of
these assets to their carrying amounts. Accordingly, the Primary
Care Portfolio was written down by $695,000 to a carrying value
of $10,000,000 and Permax written down by $9,400,000 to a
carrying value of $17,600,000.
F-32
During 2003, the Group disposed of its Swedish drug delivery and
development business (see note 11) and accordingly
intangible assets with a carrying value of $145,000 were
eliminated on disposal.
In 2002, the Company paid $100,000 (approximately £66,000)
to Elan for an option to acquire exclusive US rights to Zelapar,
a product in development for Parkinsons disease. This
product was sold on 25 February 2004. No impairment arose
as the net realizable amount equaled its carrying value at the
time of disposal.
Company
|
|
|
|
|
|
|
Product rights
|
|
|
|
$000
|
|
|
Cost
|
|
|
|
|
At 1 January 2003 and at
1 January 2004
|
|
|
118,754
|
|
Additions
|
|
|
7,894
|
|
Disposals
|
|
|
(120,434
|
)
|
|
|
|
|
|
At 31 December 2004, at
1 January 2005 and 31 December 2005
|
|
|
6,214
|
|
|
|
|
|
|
Amortization
|
|
|
|
|
At 1 January 2003
|
|
|
71,444
|
|
Charge for the year
|
|
|
5,466
|
|
Impairment charge
|
|
|
10,095
|
|
|
|
|
|
|
At 31 December 2003 and at
1 January 2004
|
|
|
87,005
|
|
Charge for the year
|
|
|
497
|
|
Eliminated on disposal
|
|
|
(84,834
|
)
|
|
|
|
|
|
At 31 December 2004 and at
1 January 2005
|
|
|
2,668
|
|
Charge for the year
|
|
|
232
|
|
|
|
|
|
|
At 31 December
2005
|
|
|
2,900
|
|
|
|
|
|
|
Net book value at
31 December 2005
|
|
|
3,314
|
|
|
|
|
|
|
Net book value at 31 December
2004
|
|
|
3,546
|
|
|
|
|
|
|
Net book value at 31 December
2003
|
|
|
31,749
|
|
|
|
|
|
|
F-33
|
|
20.
|
Tangible
fixed assets
|
Group
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short
|
|
|
Plant and
|
|
|
Motor
|
|
|
Fixtures
|
|
|
Computer
|
|
|
|
|
Cost
|
|
leasehold
|
|
|
equipment
|
|
|
vehicles
|
|
|
and fittings
|
|
|
equipment
|
|
|
Total
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
At 1 January 2003
|
|
|
655
|
|
|
|
4,160
|
|
|
|
85
|
|
|
|
778
|
|
|
|
969
|
|
|
|
6,647
|
|
Additions
|
|
|
|
|
|
|
365
|
|
|
|
|
|
|
|
55
|
|
|
|
242
|
|
|
|
662
|
|
Disposals
|
|
|
(362
|
)
|
|
|
(4,350
|
)
|
|
|
(85
|
)
|
|
|
|
|
|
|
(504
|
)
|
|
|
(5,301
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December 2003 and at
1 January 2004
|
|
|
293
|
|
|
|
175
|
|
|
|
|
|
|
|
833
|
|
|
|
707
|
|
|
|
2,008
|
|
Additions
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9
|
|
|
|
9
|
|
Acquisitions
|
|
|
116
|
|
|
|
|
|
|
|
|
|
|
|
92
|
|
|
|
9
|
|
|
|
217
|
|
Disposals
|
|
|
|
|
|
|
(175
|
)
|
|
|
|
|
|
|
(738
|
)
|
|
|
(444
|
)
|
|
|
(1,357
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December 2004 and at
1 January 2005
|
|
|
409
|
|
|
|
|
|
|
|
|
|
|
|
187
|
|
|
|
281
|
|
|
|
877
|
|
Additions
|
|
|
|
|
|
|
37
|
|
|
|
|
|
|
|
5
|
|
|
|
126
|
|
|
|
168
|
|
Disposals
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(66
|
)
|
|
|
(66
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December
2005
|
|
|
409
|
|
|
|
37
|
|
|
|
|
|
|
|
192
|
|
|
|
341
|
|
|
|
979
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
depreciation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 1 January 2003
|
|
|
61
|
|
|
|
3,255
|
|
|
|
64
|
|
|
|
145
|
|
|
|
736
|
|
|
|
4,261
|
|
Charge for the year
|
|
|
29
|
|
|
|
203
|
|
|
|
3
|
|
|
|
138
|
|
|
|
178
|
|
|
|
551
|
|
Eliminated on disposals
|
|
|
(10
|
)
|
|
|
(3,334
|
)
|
|
|
(67
|
)
|
|
|
|
|
|
|
(424
|
)
|
|
|
(3,835
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December 2003 and at
1 January 2004
|
|
|
80
|
|
|
|
124
|
|
|
|
|
|
|
|
283
|
|
|
|
490
|
|
|
|
977
|
|
Charge for the year
|
|
|
35
|
|
|
|
|
|
|
|
|
|
|
|
23
|
|
|
|
97
|
|
|
|
155
|
|
Eliminated on disposals
|
|
|
|
|
|
|
(124
|
)
|
|
|
|
|
|
|
(236
|
)
|
|
|
(322
|
)
|
|
|
(682
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December 2004 and at
1 January 2005
|
|
|
115
|
|
|
|
|
|
|
|
|
|
|
|
70
|
|
|
|
265
|
|
|
|
450
|
|
Charge for the year
|
|
|
50
|
|
|
|
8
|
|
|
|
|
|
|
|
41
|
|
|
|
36
|
|
|
|
135
|
|
Eliminated on disposals
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(66
|
)
|
|
|
(66
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December
2005
|
|
|
165
|
|
|
|
8
|
|
|
|
|
|
|
|
111
|
|
|
|
235
|
|
|
|
519
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net book value
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December
2005
|
|
|
244
|
|
|
|
29
|
|
|
|
|
|
|
|
81
|
|
|
|
106
|
|
|
|
460
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December 2004
|
|
|
294
|
|
|
|
|
|
|
|
|
|
|
|
117
|
|
|
|
16
|
|
|
|
427
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December 2003
|
|
|
213
|
|
|
|
51
|
|
|
|
|
|
|
|
550
|
|
|
|
217
|
|
|
|
1,031
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-34
Plant and equipment includes assets held under finance leases
and purchase contracts as follows:
|
|
|
|
|
Cost
|
|
$000
|
|
|
At 1 January 2003
|
|
|
902
|
|
Additions
|
|
|
319
|
|
Disposals
|
|
|
(1,221
|
)
|
|
|
|
|
|
At 31 December 2003,
1 January 2004, 31 December 2004 and at 1 January
2005
|
|
|
|
|
Additions
|
|
|
33
|
|
|
|
|
|
|
At 31 December
2005
|
|
|
33
|
|
|
|
|
|
|
Accumulated
depreciation
|
|
|
|
|
At 1 January 2003
|
|
|
804
|
|
Charge for year
|
|
|
134
|
|
Disposals
|
|
|
(938
|
)
|
|
|
|
|
|
At 31 December 2003,
1 January 2004, 31 December 2004 and at 1 January
2005
|
|
|
|
|
Charge for the year
|
|
|
8
|
|
|
|
|
|
|
At 31 December
2005
|
|
|
8
|
|
|
|
|
|
|
Net book value
|
|
|
|
|
At 31 December
2005
|
|
|
25
|
|
|
|
|
|
|
At 31 December 2004
|
|
|
|
|
|
|
|
|
|
At 31 December 2003
|
|
|
|
|
|
|
|
|
|
F-35
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short
|
|
|
Plant and
|
|
|
Motor
|
|
|
Fixtures
|
|
|
Computer
|
|
|
|
|
Company Cost
|
|
leasehold
|
|
|
equipment
|
|
|
vehicles
|
|
|
and fittings
|
|
|
equipment
|
|
|
Total
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
At 1 January 2003
|
|
|
293
|
|
|
|
|
|
|
|
60
|
|
|
|
95
|
|
|
|
261
|
|
|
|
709
|
|
Additions
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6
|
|
|
|
6
|
|
Disposals
|
|
|
|
|
|
|
|
|
|
|
(60
|
)
|
|
|
|
|
|
|
|
|
|
|
(60
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December 2003 and at
1 January 2004
|
|
|
293
|
|
|
|
|
|
|
|
|
|
|
|
95
|
|
|
|
267
|
|
|
|
655
|
|
Additions
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9
|
|
|
|
9
|
|
Disposals
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3
|
)
|
|
|
(3
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December 2004 and at
1 January 2005
|
|
|
293
|
|
|
|
|
|
|
|
|
|
|
|
95
|
|
|
|
273
|
|
|
|
661
|
|
Additions
|
|
|
|
|
|
|
4
|
|
|
|
|
|
|
|
5
|
|
|
|
71
|
|
|
|
80
|
|
Disposals
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(66
|
)
|
|
|
(66
|
)
|
Transferred to subsidiary
undertaking
|
|
|
|
|
|
|
(4
|
)
|
|
|
|
|
|
|
(5
|
)
|
|
|
(32
|
)
|
|
|
(41
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December
2005
|
|
|
293
|
|
|
|
|
|
|
|
|
|
|
|
95
|
|
|
|
246
|
|
|
|
634
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
depreciation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 1 January 2003
|
|
|
52
|
|
|
|
|
|
|
|
39
|
|
|
|
30
|
|
|
|
178
|
|
|
|
299
|
|
Charge for the year
|
|
|
28
|
|
|
|
|
|
|
|
|
|
|
|
16
|
|
|
|
51
|
|
|
|
95
|
|
Disposals
|
|
|
|
|
|
|
|
|
|
|
(39
|
)
|
|
|
|
|
|
|
|
|
|
|
(39
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December 2003 and at
1 January 2004
|
|
|
80
|
|
|
|
|
|
|
|
|
|
|
|
46
|
|
|
|
229
|
|
|
|
355
|
|
Charge for the year
|
|
|
31
|
|
|
|
|
|
|
|
|
|
|
|
20
|
|
|
|
33
|
|
|
|
84
|
|
Disposals
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1
|
)
|
|
|
(1
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December 2004 and at
1 January 2005
|
|
|
111
|
|
|
|
|
|
|
|
|
|
|
|
66
|
|
|
|
261
|
|
|
|
438
|
|
Charge for the year
|
|
|
29
|
|
|
|
|
|
|
|
|
|
|
|
19
|
|
|
|
26
|
|
|
|
74
|
|
Disposals
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(66
|
)
|
|
|
(66
|
)
|
Transferred to subsidiary
undertaking
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6
|
)
|
|
|
(6
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December
2005
|
|
|
140
|
|
|
|
|
|
|
|
|
|
|
|
85
|
|
|
|
215
|
|
|
|
440
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net book value
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December
2005
|
|
|
153
|
|
|
|
|
|
|
|
|
|
|
|
10
|
|
|
|
31
|
|
|
|
194
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December 2004
|
|
|
182
|
|
|
|
|
|
|
|
|
|
|
|
29
|
|
|
|
12
|
|
|
|
223
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December 2003
|
|
|
213
|
|
|
|
|
|
|
|
|
|
|
|
49
|
|
|
|
38
|
|
|
|
300
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company had no tangible fixed assets under finance leases at
31 December 2005, 2004 or 2003.
F-36
|
|
21.
|
Fixed
asset investments
|
Group
The Group had no fixed asset investments as 31 December
2005, 2004 or 2003.
Company
|
|
|
|
|
|
|
Group undertakings
|
|
|
|
$000
|
|
|
Cost
|
|
|
|
|
At 1 January 2003 and 2004
and 31 December 2003
|
|
|
1,660
|
|
Additions
|
|
|
4,593
|
|
|
|
|
|
|
At 31 December 2004 and at
1 January and 31 December 2005
|
|
|
6,253
|
|
|
|
|
|
|
Interest
in group undertakings at 31 December 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proportion of nominal
|
|
|
|
Country of
|
|
|
|
value of issued share
|
|
|
|
incorporation
|
|
|
|
capital held by the
|
|
Name of Undertaking
|
|
or registration
|
|
Description of shares
held
|
|
Group
|
|
|
Company
|
|
|
|
|
|
|
|
%
|
|
|
%
|
|
|
Amarin Pharmaceuticals Company
Limited
|
|
England and Wales
|
|
1,599,925 £1 ordinary shares
|
|
|
100
|
|
|
|
100
|
|
Ethical Pharmaceuticals (UK)
Limited
|
|
England and Wales
|
|
16,262 £1 ordinary shares
|
|
|
100
|
|
|
|
100
|
|
|
|
|
|
11,735 £1 A
ordinary shares
|
|
|
100
|
|
|
|
100
|
|
|
|
|
|
375,050 £1 redeemable
cumulative preference shares
|
|
|
100
|
|
|
|
100
|
|
|
|
|
|
5,421 £1 redeemable
convertible
cumulative preference shares
|
|
|
100
|
|
|
|
100
|
|
Amarin Neuroscience Limited
|
|
Scotland
|
|
4,000,000 £1 ordinary shares
|
|
|
100
|
|
|
|
100
|
|
Amarin Pharmaceuticals Ireland
Limited
|
|
Ireland
|
|
100 1 ordinary shares
|
|
|
100
|
|
|
|
100
|
|
Amarin Neuroscience Limited was acquired on 8 October 2004
and accounted for using acquisition accounting.
Amarin Pharmaceuticals Ireland Limited was incorporated on
5 October 2005 as a fully owned subsidiary of Amarin
Corporation plc.
Research
and development company
Amarin Neuroscience Limited.
Management
services company
Amarin Pharmaceuticals Ireland Limited.
Intermediate
holding company
Amarin Pharmaceuticals Company Limited.
Non
trading company
Ethical Pharmaceuticals (UK) Limited.
In October 2003, the Group disposed of its interests in Gacell
Holdings AB and Amarin Development (Sweden) AB. In February
2004, the Group disposed of its interests in the US sales and
marketing business, Amarin Pharmaceuticals Inc.
F-37
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Group
|
|
|
Company
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Raw materials and consumables
|
|
|
|
|
|
|
|
|
|
|
274
|
|
|
|
|
|
|
|
|
|
|
|
274
|
|
Finished goods and goods for resale
|
|
|
|
|
|
|
|
|
|
|
2,377
|
|
|
|
|
|
|
|
|
|
|
|
2,377
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,651
|
|
|
|
|
|
|
|
|
|
|
|
2,651
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Group
|
|
|
Company
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Amounts falling due within one
year
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trade debtors
|
|
|
|
|
|
|
|
|
|
|
418
|
|
|
|
|
|
|
|
|
|
|
|
418
|
|
Amounts owed by Group undertakings
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,966
|
|
|
|
5,418
|
|
|
|
1,417
|
|
Corporation tax receivable
|
|
|
1,312
|
|
|
|
1,103
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other debtors
|
|
|
772
|
|
|
|
212
|
|
|
|
916
|
|
|
|
199
|
|
|
|
124
|
|
|
|
916
|
|
Prepayments and accrued income
|
|
|
682
|
|
|
|
688
|
|
|
|
1,015
|
|
|
|
496
|
|
|
|
527
|
|
|
|
1,015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,766
|
|
|
|
2,003
|
|
|
|
2,349
|
|
|
|
13,661
|
|
|
|
6,069
|
|
|
|
3,766
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
No provision or charge against bad or doubtful debts has been
made during 2005, 2004 or 2003. Included in other debtors at
31 December 2005 is an amount $1,445 (31 December 2004
and 2003: nil) advanced to one of our directors Richard Stewart
to cover travel expenses. This amount will be offset against
future expense claims as the expense is incurred.
Corporation tax receivable relates to tax credits for research
and development held within Amarin Neuroscience Limited.
|
|
24.
|
Current
asset investments
|
The Group holds an investment in Antares Pharma Inc.
(Antares) (formerly Medi-Ject Corporation), which is
listed on the American Stock Exchange (AMEX) in the United
States. In 2002, the directors wrote off the carrying value of
the investment in Antares. At 31 December 2005, the market
value of this investment was $24,000 (31 December 2004:
$21,000, 31 December 2003: $16,000).
F-38
|
|
25.
|
Creditors:
amounts falling due within one year
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Group
|
|
|
Company
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Current portion of other loans
|
|
|
|
|
|
|
|
|
|
|
31,500
|
|
|
|
|
|
|
|
|
|
|
|
31,500
|
|
Trade creditors
|
|
|
779
|
|
|
|
1,088
|
|
|
|
3,564
|
|
|
|
309
|
|
|
|
441
|
|
|
|
3,564
|
|
Amounts owed to group undertakings
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16,028
|
|
|
|
15,435
|
|
|
|
13,367
|
|
Obligations under finance leases
|
|
|
11
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporation tax payable
|
|
|
83
|
|
|
|
93
|
|
|
|
571
|
|
|
|
83
|
|
|
|
93
|
|
|
|
571
|
|
Other taxation and social security
payable
|
|
|
115
|
|
|
|
193
|
|
|
|
116
|
|
|
|
49
|
|
|
|
62
|
|
|
|
116
|
|
Other creditors
|
|
|
745
|
|
|
|
255
|
|
|
|
4,321
|
|
|
|
731
|
|
|
|
214
|
|
|
|
4,321
|
|
Accruals and deferred income
|
|
|
6,267
|
|
|
|
2,712
|
|
|
|
13,653
|
|
|
|
2,563
|
|
|
|
2,301
|
|
|
|
13,653
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,000
|
|
|
|
4,341
|
|
|
|
53,725
|
|
|
|
19,763
|
|
|
|
18,546
|
|
|
|
67,092
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In February 2004, Amarin settled its entire debt obligations due
to Elan by the payment of $17,195,000 (part of which represented
the cost of acquiring Zelapar that was concurrently sold to
Valeant) and the issuance of a loan note of $5,000,000 and
500,000 warrants. The loan note carried interest at 8% per
annum and was repayable by installment commencing after one year
of the balance sheet date. During September 2004, Elan sold its
remaining interests in Amarin Investment Holding Limited, an
entity controlled by Mr. Thomas Lynch, the non-executive
Chairman of Amarin. These interests included the $5,000,000 loan
note and 500,000 warrants. During October 2004, Mr. Lynch
agreed to redeem $3,000,000 of the loan note for 2,717,391
ordinary shares with an option to redeem the remaining
$2 million at the offering price of any future equity
financing. Accordingly, a convertible loan note of $2,000,000
remained outstanding at 31 December 2004. This convertible
loan note carries daily interest of 8% per annum payable
half yearly. During May 2005, AIHL redeemed the remaining
$2 million of the loan note and subscribed for 1,538,461
ordinary shares.
During 2003, following renegotiation of liabilities due to Elan,
a related party, all amounts due became payable by 31 March
2004 (see note 41). Accordingly, all amounts payable to
Elan were classified as due within one year.
At 31 December 2002, the Company held an unsecured loan
from related parties of a total principal amount of $42,500,000
of which $27,500,000 was due within one year. Of this amount,
$17,500,000 was repayable at 31 December 2002, with the
remaining $10,000,000 due in 2003. This loan carried interest at
2% above dollar LIBOR. On January 16, 2003 $17,500,000 was
paid. The remaining $10,000,000 was restructured and deferred by
one year. Following renegotiation in August 2003, all amounts
due under this loan ($25,000,000) became payable within one year
and it was settled in February 2004 (see note 41).
At 31 December 2002, the Company owed $12,500,000 relating
to deferred fixed payments due as a result of the exercise of
the option to acquire Permax (a further $15,000,000 of deferred
fixed payments were due after one year). These amounts did not
bear interest. During 2003, $5,000,000 was paid against these
liabilities and an amount of $7,500,000 was waived by Elan.
Following the renegotiation with Elan (see note 41), all
deferred fixed payments were reclassified as due within one
year. Following the sale of the Groups Swedish drug
delivery and development business (see note 11) part
of the proceeds ($11,102,000) was applied to the total deferred
fixed payments to leave a balance at the 2003 year end of
$3,898,000. The remaining balance was then settled in February
2004.
During 2003, the Group disposed of its Swedish operations.
Watson Pharmaceuticals, Inc. holds a floating charge over the
Groups net assets relating to the sale of Amarin
Development. The charge relates solely to lost share
certificates and has been matched by an insurance policy held by
the Group.
At 31 December 2003, Elan held a fixed and floating charge
over all of the Groups assets to secure the Groups
obligations, both debt and deferred consideration (the
Elan Security). In addition the Elan Security secured a
guarantee that Elan has given to Eli Lilly and Company relating
to the Groups 2002 acquisition of Permax. As part of the
purchase of Elans debt and equity interest in the Group by
Amarin Investment Holding Limited (AIHL), an
F-39
entity controlled by Mr. Thomas Lynch, the non-executive
chairman of Amarin, the Elan Security was assigned to AIHL and
then was subsequently discharged by agreement between the Group
and AIHL.
|
|
26.
|
Creditors:
amounts falling due after more than one year
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Group
|
|
|
Company
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Obligations under finance leases
|
|
|
14
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other creditors
|
|
|
151
|
|
|
|
|
|
|
|
|
|
|
|
151
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
165
|
|
|
|
|
|
|
|
|
|
|
|
151
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Analysis
of repayments
Bank overdrafts, bank loans and other loans are repayable as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Group
|
|
|
Company
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Within one year or on demand
|
|
|
|
|
|
|
|
|
|
|
35,398
|
|
|
|
|
|
|
|
|
|
|
|
35,398
|
|
Between one and two years
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Between two and five years
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
35,398
|
|
|
|
|
|
|
|
|
|
|
|
35,398
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The future minimum lease payments to which the Group and the
Company are committed under finance leases are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Group
|
|
|
Company
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Less than one year
|
|
|
13
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Between one and two years
|
|
|
15
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less: interest
|
|
|
(3
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less: current maturities
|
|
|
(11
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term maturity
|
|
|
14
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
27.
|
Convertible
loan note
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Group
|
|
|
Company
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Convertible loan note
|
|
|
|
|
|
|
2,000
|
|
|
|
|
|
|
|
|
|
|
|
2,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A loan note of $2,000,000 remained outstanding at
31 December 2004. This loan note carried daily interest of
8% per annum payable half yearly. The loan note matures in
January 2009. AIHL redeemed the remaining $2 million of the
loan note and subscribed for 1,538,461 ordinary shares as part
of the registered direct offering completed in May 2005.
F-40
|
|
28.
|
Provisions
for liabilities and charges
|
Group and
Company
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
National
|
|
|
|
|
|
|
|
|
|
insurance
|
|
|
Mill Valley lease
provision
|
|
|
Total
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
At 1 January 2003
|
|
|
50
|
|
|
|
|
|
|
|
50
|
|
(Released) to the profit and loss
account
|
|
|
(50
|
)
|
|
|
|
|
|
|
(50
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December 2003 and at
1 January 2004
|
|
|
|
|
|
|
|
|
|
|
|
|
Charged to the profit and loss
account
|
|
|
32
|
|
|
|
655
|
|
|
|
687
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December 2004 and at
1 January 2005
|
|
|
32
|
|
|
|
655
|
|
|
|
687
|
|
(Released)
to the profit and loss account
|
|
|
(17
|
)
|
|
|
(655
|
)
|
|
|
(672
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December
2005
|
|
|
15
|
|
|
|
|
|
|
|
15
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Following the disposal of Amarins US operations, Amarin
remained liable for costs associated with the vacant US head
quarters, based in Mill Valley, California. The lease was
Amarins obligation through to 31 October 2007. In
November 2005, Amarin signed an agreement with the landlord
terminating the lease on payment of a $500,000 termination
penalty. $300,000 of this penalty was paid in December 2005. The
remaining balance is due within 30 days of the
22 December 2005 financing. The remaining balance was paid
on 19 January 2006. Included in other creditors due within
one year is an amount for $200,000 which relates to the
remaining balance.
The provision for employers National Insurance
contributions shown above relates to amounts due on the exercise
of certain share options held by employees provided in
accordance with UITF 25 which will accumulate over the vesting
period of relevant options.
|
|
29.
|
Financial
instruments
|
The Group has available financial instruments including
preference shares, borrowings, finance leases, provisions, cash
and other liquid resources, and various items, such as trade
debtors, trade creditors etc, that arise directly from its
operations. The main purpose of these financial instruments is
to raise finance for the Groups operations.
It is, and has been throughout the year under review, the
Groups policy not to enter into derivative instruments.
This was also the case in the 2004 and 2003 financial years. The
Group has held ordinary shares in other companies as current
asset investments and these are shown as appropriate on the
balance sheet. However, the holding of investments in other
companies is not a principal activity of the Group and during
the last three years the majority of these holdings have been
provided against where no market exists for them, or sold where
possible. At 31 December 2005, the value of traded shares
in other companies was $nil (2004 and 2003: $nil) and the gain
made in the year on the sale of current asset investments
credited to the profit and loss account was $nil (2004 and 2003:
$nil).
The main risks arising from the Groups financial
instruments are interest rate risk, liquidity risk and foreign
currency risk. Details of the Groups financial instruments
with regard to interest rate risk and foreign currency risk are
disclosed in the following sections to this note. It has been,
and continues to be, the policy of the Board to minimize the
exposure of the Group to these risks.
In February 2004, the Group disposed of its remaining overseas
operations based in the US. In 2004, the US sales accounted for
all of the Groups total revenues. During the majority of
2003, the Group had two principal overseas operations in
different territories: the USA and Sweden. The revenues and
expenses of the operations in the USA were denominated in US
dollars and those of the Swedish operation in Swedish Kroner. In
2003 sales to the US accounted for approximately 36% of the
Groups total revenues. In order to protect the
Groups liquidity from fluctuations in the US
dollar/sterling exchange rate, the bulk of the Groups
borrowings were denominated in US dollars. During October 2003,
the Swedish subsidiary was sold and during February 2004, the
American subsidiary was sold. The Swedish subsidiary was
supported by a bank overdraft denominated in Swedish Kroner.
Further
F-41
financing for it was provided out of Group funds. The US
business was supported by US dollar loans held by Group
companies with the US dollar as their functional currency.
The balance sheet positions at 31 December 2005, 2004 and
2003 are not representative of the position throughout the
period as cash and short-term investments, loans and shares
fluctuate considerably depending on when fund-raising activities
have occurred. Short-term debtors and creditors have been
excluded from all the following disclosures, other than currency
risk disclosures, as permitted by Financial Reporting Standard
13 (Derivatives and other financial instruments).
Liquidity
risk
The Group has historically financed its operations through a
number of loan facilities. The Group has, where possible,
entered into long term borrowing facilities in order to protect
short term liquidity. More recently, Amarin has raised finance
by a private placement of ordinary shares and intends to obtain
additional funding through earning license fees from partnering
its drug development pipeline and/or completing further
equity-based financings.
Credit
risk
The Company is exposed to credit-related losses in the event of
non-performance by third parties to financial instruments. The
Company does not expect any third parties to fail to meet their
obligations given the policy of selecting only parties with high
credit ratings and minimizing its exposure to any one
institution.
Creditor
payment policy
It is Amarins normal procedure to agree terms of
transactions, including payment terms, with suppliers in
advance. Payment terms vary, reflecting local practice
throughout the world. It is Amarins policy that payment is
made on time, provided suppliers perform in accordance with the
agreed terms. Group trade creditors at 31 December 2005
were equivalent to 11 days purchases during the year.
Amarins policy follows the DTIs Better Payment
Policy, copies of which can be obtained from the Better Payments
Groups website.
Interest
rate risk profile of financial liabilities
The Groups financial long term liabilities, other than
short-term creditors (which have been excluded), have comprised
provisions, finance leases and loans.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
Floating
|
|
|
Fixed
|
|
|
No
|
|
|
|
|
|
Floating
|
|
|
Fixed
|
|
|
No
|
|
|
|
|
|
Floating
|
|
|
Fixed
|
|
|
No
|
|
|
|
|
|
|
Rate
|
|
|
Rate
|
|
|
Interest
|
|
|
Total
|
|
|
Rate
|
|
|
Rate
|
|
|
Interest
|
|
|
Total
|
|
|
Rate
|
|
|
Rate
|
|
|
Interest
|
|
|
Total
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Sterling
|
|
|
|
|
|
|
25
|
|
|
|
151
|
|
|
|
176
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
US Dollar
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,000
|
|
|
|
|
|
|
|
2,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial liabilities
|
|
|
|
|
|
|
25
|
|
|
|
151
|
|
|
|
176
|
|
|
|
|
|
|
|
2,000
|
|
|
|
|
|
|
|
2,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In February 2004, all debt obligations due to Elan were settled
by a cash payment of $17,195,000 (part of which represented the
cost of acquiring Zelapar that was concurrently sold to Valeant)
and the issuance of a loan note for $5,000,000 and 500,000
warrants. The loan note carried interest at 8% per annum
and was repayable by installment commencing after one year of
the balance sheet date. During September 2004, Elan sold its
remaining interests in Amarin to Amarin Investment Holding
Limited, an entity controlled by Mr. Thomas Lynch, the
non-executive Chairman of Amarin. These interests included the
$5,000,000 loan note and 500,000 warrants. During October 2004,
Mr. Lynch agreed to convert $3,000,000 of the loan note
into 2,717,391 ordinary shares with the option to convert the
remaining $2 million at the offering price of any future
equity financing. As part of the registered direct offering
completed in May 2005, AIHL redeemed the remaining
$2 million of the loan note and subscribed for 1,538,461
ordinary shares.
F-42
During 2003, all long term obligations to Elan became due within
one year of the balance sheet date. Previously the floating rate
financial liabilities comprised loans, finance lease obligations
and bank overdrafts. These bore interest at rates based on
national London Interbank Bid Rate (LIBID) equivalents which is
the rate bid by banks on Eurocurrency deposits.
The preference shares attracted dividends at 3% per annum
and were not redeemable but were convertible on, or after,
30 December 2001. During 2002, 2,129,819 of these shares
were converted into ordinary shares. The remaining 2,000,000
were converted in 2003 (see note 30).
Interest
rate risk profile of financial assets
The Groups financial assets, other than short-term
debtors, which have been excluded, comprise cash, short-term
deposits and current asset investments.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
Floating
|
|
|
Fixed
|
|
|
No
|
|
|
|
|
|
Floating
|
|
|
Fixed
|
|
|
No
|
|
|
|
|
|
Floating
|
|
|
Fixed
|
|
|
No
|
|
|
|
|
|
|
Rate
|
|
|
Rate
|
|
|
Interest
|
|
|
Total
|
|
|
Rate
|
|
|
Rate
|
|
|
Interest
|
|
|
Total
|
|
|
Rate
|
|
|
Rate
|
|
|
Interest
|
|
|
Total
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Sterling
|
|
|
3,429
|
|
|
|
|
|
|
|
|
|
|
|
3,429
|
|
|
|
8,105
|
|
|
|
|
|
|
|
|
|
|
|
8,105
|
|
|
|
318
|
|
|
|
|
|
|
|
|
|
|
|
318
|
|
Euro
|
|
|
548
|
|
|
|
|
|
|
|
|
|
|
|
548
|
|
|
|
34
|
|
|
|
|
|
|
|
|
|
|
|
34
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
US Dollar
|
|
|
29,930
|
|
|
|
|
|
|
|
|
|
|
|
29,930
|
|
|
|
2,850
|
|
|
|
|
|
|
|
|
|
|
|
2,850
|
|
|
|
1,779
|
|
|
|
|
|
|
|
|
|
|
|
1,779
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
33,907
|
|
|
|
|
|
|
|
|
|
|
|
33,907
|
|
|
|
10,989
|
|
|
|
|
|
|
|
|
|
|
|
10,989
|
|
|
|
2,097
|
|
|
|
|
|
|
|
|
|
|
|
2,097
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The floating rate financial assets comprise cash balances. The
majority of cash is generally held in floating rate accounts
earning interest based on relevant national LIBID equivalents.
Foreign
currency risk profile
In February 2004, the Group disposed of its US operations and in
October 2004 acquired Laxdale Limited, a development company
based in Scotland. During 2003, the Group disposed of its
Swedish subsidiary and also changed its functional and reporting
currency from sterling to US dollars.
At 31 December 2005, Group companies with US dollar as
their functional currency held the following monetary assets and
liabilities in the following currencies, other than their local
currency:
|
|
|
|
|
|
|
|
|
|
|
Monetary Assets
|
|
|
Monetary Liabilities
|
|
|
|
$000
|
|
|
$000
|
|
|
Sterling
|
|
|
3,995
|
|
|
|
2,881
|
|
Euro
|
|
|
465
|
|
|
|
113
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,460
|
|
|
|
2,994
|
|
At 31 December 2004, the Group companies held sterling
monetary assets of $609,000 and monetary liabilities of
$2,789,000. At 31 December 2003, the Group companies held
sterling monetary assets of $807,000 and monetary liabilities of
$3,200,000.
At 31 December 2005, Group companies with sterling as their
functional currency held the following monetary assets and
liabilities in the following currencies, other than their local
currency:
|
|
|
|
|
|
|
|
|
|
|
Monetary Assets
|
|
|
Monetary Liabilities
|
|
|
|
$000
|
|
|
$000
|
|
|
Euro
|
|
|
108
|
|
|
|
|
|
US Dollar
|
|
|
565
|
|
|
|
733
|
|
|
|
|
|
|
|
|
|
|
|
|
|
673
|
|
|
|
733
|
|
|
|
|
|
|
|
|
|
|
At 31 December 2004, Group companies with sterling as their
functional currency held monetary liabilities of $50,000 in
euro, $250,000 in yen and $77,000 in US dollars in currencies
other than their local currency.
At 31 December 2005, Group companies with Euros as their
functional currency held no monetary assets and liabilities in
currencies other than their local currency.
F-43
The Group expects the primary currency to continue to be US
dollars as the level of US dollar denominated monetary assets
and liabilities, including cash balances, increases as a result
of future equity financings and/or license fees from partnering
its drug development pipeline, together with the ongoing phase
III US trials for Huntingtons disease.
Fair
values
The preference shares described in note 30 were not traded
on an organized market. All preference shares were converted
into ordinary shares prior to December 31, 2003.
In the opinion of the directors, the fair value of the
convertible $2,000,000 loan note, at 31 December 2004, was
$1,444,000. This was calculated by discounting the cashflows
associated with the convertible loan note to its net present
value at 31 December 2004.
At 31 December 2003, the Group owed Elan the following
amounts, all of which were renegotiated during 2003 as to be due
31 March 2004. All amounts fell due within one year and the
directors considered that the carrying amounts approximated to
their fair value due to the short time to maturity.
|
|
|
|
|
US$6,500,000 non-interest bearing loan
|
|
|
|
US$3,898,000 non-interest bearing deferred consideration
|
|
|
|
US$25,000,000 interest bearing loan
|
As discussed above these were settled in February 2004.
In the opinion of the directors, the carrying amount of all
other significant financial instruments approximates to their
fair value, due to their short maturity periods or floating rate
interest rates.
Maturity
risk profile
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
|
|
|
Finance
|
|
|
|
|
|
|
|
|
Finance
|
|
|
|
|
|
|
|
|
Finance
|
|
|
|
|
|
|
Debt
|
|
|
Leases
|
|
|
Total
|
|
|
Debt
|
|
|
Leases
|
|
|
Total
|
|
|
Debt
|
|
|
Leases
|
|
|
Total
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
In one year or less
|
|
|
|
|
|
|
11
|
|
|
|
11
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
35,398
|
|
|
|
|
|
|
|
35,398
|
|
In more than one year but less
than two years
|
|
|
|
|
|
|
14
|
|
|
|
14
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In more than two years but not
more than five years
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,000
|
|
|
|
|
|
|
|
2,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
|
25
|
|
|
|
25
|
|
|
|
2,000
|
|
|
|
|
|
|
|
2,000
|
|
|
|
35,398
|
|
|
|
|
|
|
|
35,398
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December 2005, 2004 and 2003, the Group had no
overdraft facilities. The Group has no undrawn committed
borrowing facilities as at 31 December 2005 (2004: nil,
2003: nil).
See note 41 for details of the renegotiation of the other
loan and deferred consideration during 2004.
F-44
|
|
30.
|
Called-up
share capital
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Authorized
|
|
|
|
|
|
|
|
|
|
|
|
|
1,559,144,066 ordinary shares of
£0.05 each (1,559,144,066 ordinary shares of £0.05
each for 31 December 2004 and 95,000,000 ordinary shares of
£1 each for 31 December 2003.)
|
|
|
125,319
|
|
|
|
125,319
|
|
|
|
152,828
|
|
Nil deferred shares of £0.95
each (31 December 2004: 17,939,786 and 31 December
2003: nil)
|
|
|
|
|
|
|
27,509
|
|
|
|
|
|
Nil 3% cumulative convertible
preference shares of £1 each (31 December 2004 and
2003: 5,000,000)
|
|
|
|
|
|
|
8,050
|
|
|
|
8,050
|
|
440,855,934 preference shares of
£0.05 (31 December 2004 and 2003: nil)
|
|
|
40,566
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
165,885
|
|
|
|
160,878
|
|
|
|
160,878
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allotted, called up and fully
paid
|
|
|
|
|
|
|
|
|
|
|
|
|
77,548,908 ordinary shares of
£0.05 each (31 December 2004: 37,632,123,
31 December 2003: 17,939,786, ordinary shares of £1
each)
|
|
|
6,778
|
|
|
|
3,206
|
|
|
|
29,088
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issue of
share capital
On 23 January 2006, the Company issued a total of 840,000
ordinary £0.05 shares as follows:
|
|
|
|
|
800,000 shares in consideration for $2,000,000 (nominal
value of $71,000) raised in the 23 January 2006 private
equity placement, the proceeds of which will be used to fund the
combined operations of Amarin and Amarin Neuroscience
Limited; and
|
|
|
|
40,000 shares in consideration for $100,000 (nominal value
of $4,000) raised in the 23 January 2006 private equity
placement, the proceeds of which will be used to fund the
combined operations of Amarin and Amarin Neuroscience Limited;
|
In January 2006, the Company issued 295,529 shares due to
the exercise of share options of nominal value $26,000 in
aggregate for a total consideration of $828,000. In February
2006, the Company issued 240,298 shares due to the exercise
of share options of nominal value $21,000 in aggregate for a
total consideration of $837,000. In March 2006, the Company
issued 5,000 shares due to the exercise of share options of
nominal value $1,000 in aggregate for a total consideration of
$18,000.
On 22 December 2005, the Company issued a total of
26,100,098 ordinary £0.05 shares as follows:
26,100,098 shares in consideration for $26,361,000 (nominal
value of $2,307,000) raised in the 22 December 2005 private
offering of equity, the proceeds of which were used to fund the
combined operations of Amarin and Amarin Neuroscience Limited.
At an extraordinary general meeting of the Company on
September 12, 2005 the Company reduced its authorized share
capital from £100,000,000 to £77,957,203 by removal of
the existing class of 3% cumulative convertible preference
shares and the existing class of deferred shares, none of which
were in issue and the Company subsequently increased its
authorized share capital back to £100,000,000 by the
creation of 440,855,934 new preference shares of 5 pence each.
On 24 May 2005, the Company issued a total of 13,677,110
ordinary £0.05 shares as follows:
|
|
|
|
|
12,138,649 shares in consideration for $15,780,000 (nominal
value of $1,111,000) raised in the 24 May 2005 registered
direct offering of equity, the proceeds of which were used to
fund the combined operations of Amarin and Amarin Neuroscience
Limited; and
|
|
|
|
1,538,461 shares in consideration of the redemption of
$2,000,000 (nominal value $141,000) of debt into equity on
24 May 2005.
|
F-45
In connection with the completion of our May 2005 registered
direct offering of Ordinary Shares, represented by American
Depositary Shares, evidenced by American Depositary Receipts
(ADRs), which raised gross proceeds of
$17.78 million, investors in the offering were given the
future investment right described below.
If, by March 15, 2006, the Company has not raised gross
proceeds of at least $10.0 million (the Future
Financing Amount) from (i) revenues from the
licensing or partnering of the Companys intellectual
property or proprietary information that are receivable prior to
March 15, 2006, (ii) the issuance of Ordinary Shares
at a price per Ordinary Share of at least $2.50
and/or
(iii) funds received by the Company in connection with the
exercise of outstanding warrants, then, at any time between
March 15, 2006 and March 31, 2006, the original
investors in the offering will have a pro rata right to make an
equity investment in the Company at a price per Ordinary Share
equal to the lower of (a) $1.75 and (b) 84% of the
volume weighted average of closing prices of the ADRs on the
Nasdaq Stock Market over the thirty trading days ending on
March 15, 2006, in an amount up to the Future Financing
Amount, less any amounts actually raised pursuant to
clauses (i), (ii) and (iii) above. To the extent
that any investor elects not to take part in such financing, the
unallocated portion of the Future Financing Amount will be
allocated on a pro rata basis among those investors who have
elected to take part in the financings, until all of the Future
Financing Amount has been allocated to investors that wish to
take part in the financing. The Future Financing Amount shall be
reduced on a
dollar-for-dollar
basis to the extent that the gross amount raised in the May
Offering exceeds $15 million.
As the gross proceeds in the offering were $17.78 million,
or $2.78 million in excess of $15 million, the Future
Financing Amount of $10 million is reduced by
$2.78 million to $7.22 million. As set out above, the
$7.22 million can be reduced by earning fees from out
licensing, issuing shares at a price of at least $2.50
and/or
warrants exercises. In December 2005, Amarin closed a license
agreement with Multicell generating an initial fee of $0.5m. In
January 2006, Amarin issued shares at $2.50 generating proceeds
of $2.1 million. In January and February 2006, Amarin
issued 153,000 shares at an average price of $2.88 on the
exercise of options generating proceeds of $441,000. These
transactions reduce the Future Financing Amount to
$4.18 million. Given that 84% of the volume weighted
average of closing prices of the ADRs on the Nasdaq Stock Market
over the thirty trading days ending on March 15, 2006 is
greater than $1.75, the future investment right was priced at
$1.75. As a result, it is expected that approximately
2,387,850 shares will be issued by March 31, 2006 on
the exercise by investors of the future investment right.
In January 2005, the Company issued 102,000 shares due to
the exercise of share options of nominal value $9,000 in
aggregate for a total consideration of $307,000. In February
2005, the Company issued 37,577 shares due to the exercise
of share options of nominal value $4,000 in aggregate for a
total consideration of $90,000.
On 21 June 2004, each of the issued ordinary shares of
£1 each was sub-divided and converted into one ordinary
share of £0.05 and one deferred share of £0.95.
Additionally, each authorized but unissued share of £1 each
was sub-divided into 20 ordinary shares of £0.05 each.
A fresh issue of one ordinary £0.05 share was made for
a consideration of £1. These proceeds were used by the
Company to purchase the deferred shares in issue. The deferred
shares were then cancelled by the Company and accordingly a
transfer was made for the amount of $27,633,000 to the capital
redemption reserve. Following these transactions, at
30 June 2004, there were 17,939,787 allotted, called up and
fully paid ordinary shares of £0.05. Subsequently, the
Company issued shares during October 2004 as follows:
|
|
|
|
|
13,474,945 shares in consideration for the $12,775,000
(nominal value of $1,198,000) raised in the 7 October 2004
private placement, the proceeds of which were used to fund the
combined operations of Amarin and Amarin Neuroscience Limited;
|
|
|
|
2,717,391 shares in consideration of the redemption of
$3,000,000 (nominal value of $241,000) of debt for equity on
7 October 2004; and
|
|
|
|
3,500,000 shares in consideration for the acquisition
(nominal value of $312,000) of Laxdale Limited on 8 October
2004.
|
During the year ended 31 December 2002, the nominal value
of the ordinary shares was converted from 10p to £1 and
2,129,819 of the 3% cumulative convertible preference shares of
£1 each were converted into ordinary
F-46
shares. In February 2003, the remaining 2,000,000 3% cumulative
convertible preference shares were converted into ordinary
shares. During July 2003, the authorized share capital was
increased by 45,000,000 ordinary shares of £1 each.
During January 2003, the Company raised $21,197,000 of
additional funds through the issue of 6,093,728 new ordinary
shares at $3.4785 per share. The proceeds together with
cash on hand at the year end were partially utilized to repay
the following amounts to Elan Pharma International Limited
(EPIL), a related party:
|
|
|
|
|
$2,459,880 in respect of interest accrued to 16 January
2003;
|
|
|
|
$17,500,000 in part repayment of the loans from EPIL; and
|
|
|
|
$8,641,387 in respect of other amounts related to Permax.
|
During the year ended 31 December 2003, 7,900 £1
ordinary shares were issued in respect of share options being
£7,900 nominal value in aggregate for a total consideration
of $12,000.
As at 31 December 2005, Amarin has 440,855,934 Preference
Shares of £0.05 each forming part of its authorized share
capital but none of these preference shares are in issue.
Pursuant to an authority given by the shareholders at the 2005
Annual General Meeting Amarins board of directors has the
authority, without further action by shareholders, to issue up
to 440,855,934 preference shares of £0.05 in one or more
series and to fix the rights, preferences, privileges,
qualifications and restrictions granted to or imposed upon the
preference shares, including dividend rights, conversion rights,
voting rights, rights and terms of redemption, and liquidation
preference, any or all of which may be greater than the rights
of the ordinary shares. To date, Amarins board of
directors has not issued any such preference shares.
The issuance of preference shares could adversely affect the
voting power of holders of ordinary shares and reduce the
likelihood that ordinary shareholders will receive dividend
payments and payments upon liquidation. The issuance could have
the effect of decreasing the market price of our ordinary
shares. The issuance of preference shares also could have the
effect of delaying, deterring or preventing a change in control
of the Company.
Amarins board of directors will fix the rights,
preferences, privileges, qualifications and restrictions of the
preference shares of each series that the Company sells under
this prospectus and applicable prospectus supplements in the
certificate of designation relating to that series. The Company
will incorporate by reference into the registration statement,
the form of any certificate of designation that describes the
terms of the series of preference shares Amarin are offering
before the issuance of the related series of preference shares.
This description will include:
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|
|
the title and stated value;
|
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|
|
the number of shares Amarin are offering;
|
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|
|
the liquidation preference per share;
|
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|
|
the purchase price per share;
|
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|
|
the dividend rate per share, dividend period and payment dates
and method of calculation for dividends;
|
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|
|
whether dividends will be cumulative or non-cumulative and, if
cumulative, the date from which dividends will accumulate;
|
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|
|
our right, if any, to defer payment of dividends and the maximum
length of any such deferral period;
|
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|
the procedures for any auction and remarketing, if any;
|
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|
the provisions for a sinking fund, if any;
|
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|
the provisions for redemption or repurchase, if applicable, and
any restrictions on our ability to exercise those redemption and
repurchase rights;
|
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|
|
any listing of the preference shares on any securities exchange
or market;
|
F-47
|
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|
|
whether the preference shares will be convertible into our
ordinary shares or other securities of ours, including warrants,
and, if applicable, the conversion period, the conversion price,
or how it will be calculated, and under what circumstances it
may be adjusted;
|
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|
whether the preference shares will be exchangeable into debt
securities, and, if applicable, the exchange period, the
exchange price, or how it will be calculated, and under what
circumstances it may be adjusted;
|
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|
voting rights, if any, of the preference shares;
|
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|
preemption rights, if any;
|
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|
|
restrictions on transfer, sale or other assignment, if any;
|
|
|
|
a discussion of any material or special United States federal
income tax considerations applicable to the preference shares;
|
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|
|
the relative ranking and preferences of the preference shares as
to dividend rights and rights if we liquidate, dissolve or wind
up our affairs;
|
|
|
|
any limitations on issuances of any class or series of
preference shares ranking senior to or on a parity with the
series of preference shares being issued as to dividend rights
and rights if we liquidate, dissolve or wind up our
affairs; and
|
|
|
|
any other specific terms, rights, preferences, privileges,
qualifications or restrictions of the preference shares.
|
If Amarin issue shares of preference shares the shares will be
fully paid and non-assessable and will not have, or be subject
to, any pre-emptive or similar rights.
The Companys articles of association and English Law
provide that the holders of preference shares will have the
right to vote separately as a class on any proposal involving
changes that would adversely affect the powers, preferences, or
special rights of holders of that preference share.
F-48
31. Options
and warrants over shares of Amarin Corporation plc
|
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|
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Number of share
|
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|
|
|
|
|
|
|
|
|
Number of share
|
|
options outstanding
|
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|
|
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|
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|
options repriced
|
|
over £0.05 Ordinary
|
|
|
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|
Date Option
|
|
Exercise price per
|
|
|
at US$5.00 per
|
|
Shares*
|
|
|
Note
|
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|
Granted
|
|
Ordinary Share*
|
|
|
Ordinary Share
|
|
|
|
|
|
|
|
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|
US$
|
|
|
(Note 1)
|
|
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|
100,000
|
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|
|
1
|
|
|
23 November 1998
|
|
|
25.00
|
|
|
|
100,000
|
|
|
250,000
|
|
|
|
2
|
|
|
23 November 1998
|
|
|
5.00
|
|
|
|
|
|
|
5,000
|
|
|
|
3
|
|
|
2 March 1999
|
|
|
7.22
|
|
|
|
|
|
|
5,500
|
|
|
|
4
|
|
|
7 September 1999
|
|
|
3.00
|
|
|
|
|
|
|
37,500
|
|
|
|
4
|
|
|
1 April 2000
|
|
|
3.00
|
|
|
|
|
|
|
10,000
|
|
|
|
3
|
|
|
7 April 2000
|
|
|
3.00
|
|
|
|
|
|
|
5,000
|
|
|
|
4
|
|
|
23 May 2000
|
|
|
3.00
|
|
|
|
|
|
|
3,293
|
|
|
|
4
|
|
|
26 September 2000
|
|
|
3.00
|
|
|
|
|
|
|
20,000
|
|
|
|
3
|
|
|
19 February 2001
|
|
|
6.13
|
|
|
|
|
|
|
45,000
|
|
|
|
5
|
|
|
4 June 2001
|
|
|
8.65
|
|
|
|
|
|
|
15,000
|
|
|
|
5
|
|
|
2 July 2001
|
|
|
10.00
|
|
|
|
|
|
|
6,000
|
|
|
|
5
|
|
|
27 July 2001
|
|
|
12.88
|
|
|
|
|
|
|
35,000
|
|
|
|
6
|
|
|
12 December 2001
|
|
|
16.00
|
|
|
|
|
|
|
201,500
|
|
|
|
6,7
|
|
|
23 January 2002
|
|
|
17.65
|
|
|
|
|
|
|
80,000
|
|
|
|
8
|
|
|
18 February 2002
|
|
|
13.26
|
|
|
|
|
|
|
20,000
|
|
|
|
7
|
|
|
1 May 2002
|
|
|
19.70
|
|
|
|
|
|
|
15,000
|
|
|
|
7
|
|
|
1 May 2002
|
|
|
21.30
|
|
|
|
|
|
|
5,000
|
|
|
|
7
|
|
|
19 July 2002
|
|
|
8.81
|
|
|
|
|
|
|
15,000
|
|
|
|
7
|
|
|
5 September 2002
|
|
|
3.33
|
|
|
|
|
|
|
60,000
|
|
|
|
7
|
|
|
6 November 2002
|
|
|
3.46
|
|
|
|
|
|
|
236,667
|
|
|
|
9
|
|
|
6 November 2002
|
|
|
3.10
|
|
|
|
|
|
|
105,933
|
|
|
|
10
|
|
|
24 February 2003
|
|
|
3.17
|
|
|
|
|
|
|
133,334
|
|
|
|
7
|
|
|
3 March 2003
|
|
|
2.82
|
|
|
|
|
|
|
40,000
|
|
|
|
6
|
|
|
29 April 2003
|
|
|
2.82
|
|
|
|
|
|
|
20,000
|
|
|
|
7
|
|
|
2 July 2003
|
|
|
3.37
|
|
|
|
|
|
|
70,000
|
|
|
|
6
|
|
|
21 November 2003
|
|
|
2.38
|
|
|
|
|
|
|
375,000
|
|
|
|
6
|
|
|
7 July 2004
|
|
|
0.85
|
|
|
|
|
|
|
357,500
|
|
|
|
11
|
|
|
21 July 2004
|
|
|
0.84
|
|
|
|
|
|
|
443,334
|
|
|
|
12
|
|
|
8 October 2004
|
|
|
1.25
|
|
|
|
|
|
|
111,391
|
|
|
|
13
|
|
|
8 October 2004
|
|
|
1.25
|
|
|
|
|
|
|
20,000
|
|
|
|
6
|
|
|
29 November 2004
|
|
|
2.40
|
|
|
|
|
|
|
100,000
|
|
|
|
6
|
|
|
28 February 2005
|
|
|
3.04
|
|
|
|
|
|
|
100,000
|
|
|
|
14
|
|
|
28 February 2005
|
|
|
3.04
|
|
|
|
|
|
|
350,000
|
|
|
|
15
|
|
|
28 February 2005
|
|
|
3.04
|
|
|
|
|
|
|
10,000
|
|
|
|
6
|
|
|
28 March 2005
|
|
|
2.43
|
|
|
|
|
|
|
500,000
|
|
|
|
16
|
|
|
10 June 2005
|
|
|
1.30
|
|
|
|
|
|
|
200,000
|
|
|
|
17
|
|
|
28 June 2005
|
|
|
1.09
|
|
|
|
|
|
|
160,000
|
|
|
|
6
|
|
|
28 June 2005
|
|
|
1.09
|
|
|
|
|
|
|
20,000
|
|
|
|
6
|
|
|
13 July 2005
|
|
|
1.37
|
|
|
|
|
|
|
20,000
|
|
|
|
6
|
|
|
1 September 2005
|
|
|
1.44
|
|
|
|
|
|
|
10,000
|
|
|
|
6
|
|
|
9 September 2005
|
|
|
1.42
|
|
|
|
|
|
|
20,000
|
|
|
|
6
|
|
|
20 September 2005
|
|
|
1.49
|
|
|
|
|
|
|
100,000
|
|
|
|
6
|
|
|
27 September 2005
|
|
|
1.50
|
|
|
|
|
|
|
10,000
|
|
|
|
18
|
|
|
28 October 2005
|
|
|
1.38
|
|
|
|
|
|
|
40,000
|
|
|
|
19
|
|
|
11 November 2005
|
|
|
1.15
|
|
|
|
|
|
|
325,000
|
|
|
|
20
|
|
|
2 December 2005
|
|
|
1.16
|
|
|
|
|
|
|
10,000
|
|
|
|
6
|
|
|
10 December 2005
|
|
|
1.18
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,821,952
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes:
|
|
|
* |
|
On 21 June 2004, each of the issued ordinary shares of
£1 each was sub-divided and converted into one ordinary
share of £0.05 and one deferred share of £0.95.
Additionally, each authorized but unissued share of £1 each
was sub-divided into 20 ordinary shares of £0.05 each. |
A fresh issue of one ordinary £0.05 share was made for
a consideration of £1. These proceeds were used by the
Company to purchase the deferred shares in issue. The deferred
shares were then cancelled by the Company and
F-49
accordingly a transfer was made for the amount of $27,633,000 to
the Capital Redemption Reserve. These changes do not affect
the exercise prices of options.
During 2002, the nominal value of ordinary shares was converted
from 10p to £1 each, resulting in the number of shares
reducing by a factor of 10 and increasing the exercise price by
a factor of 10.
|
|
|
|
1.
|
When granted these options were to become exercisable in
tranches upon the Companys share price achieving certain
pre-determined levels. On 9 February 2000, the
Companys remuneration committee approved the re-pricing of
these 100,000 options to an exercise price of US$0.50 per
share (US$5.00 per share following the conversion of the
nominal value of ordinary shares from 10p to £1 in 2002;
the 2004 conversion discussed above has no effect on the
exercise price), and the Company entered into an amendment
agreement on the same day amending the exercise price and also
removing the performance criteria attached to such options.
These options are currently exercisable and remain exercisable
until 23 November 2008.
|
|
|
2.
|
Of these options 80% became exercisable immediately and 20%
after six months from date of grant and are exercisable until
ten years from date of grant.
|
|
|
3.
|
These options are exercisable now and remain exercisable until
30 November 2008.
|
|
|
4.
|
These options were granted to a former employee of Amarin
Corporation plc, are now exercisable and expire on
30 November 2008.
|
|
|
5.
|
These options become exercisable in tranches of 33% over three
years on the date of the grant then on the first and second
anniversaries of the date of grant and remain exercisable for a
period of ten years from the date of grant.
|
|
|
6.
|
These options become exercisable in tranches of 33% over three
years on the first, second and third anniversary of the date of
grant and expire 10 years from the date of the grant.
|
|
|
7.
|
These options become exercisable in tranches of 33% over three
years on the first, second and third anniversary of the date
employment commences. The options expire 10 years from the
date of the grant.
|
|
|
8.
|
These options became exercisable in October 2005 and expire on
31 March 2009.
|
|
|
9.
|
These options become exercisable in tranches of 33% over three
years on the first, second and third anniversary of the date of
grant and expire 10 years from the date of the grant. Of
these options 26,667 were immediately vested in October 2005 and
expiry dated 31 March 2009.
|
|
|
10.
|
These options become exercisable in tranches of 33% over three
years on the first, second and third anniversary of the date of
grant and expire 10 years from the date of the grant. Of
these options 65,933 were immediately vested in October 2005 and
expiry dated 31 March 2009.
|
|
|
11.
|
These options become exercisable in tranches of 33% over three
years on the first, second and third anniversary of the date of
grant and expire 10 years from the date of the grant. Of
these options 125,000 were immediately vested in October 2005
and expiry dated 31 March 2009.
|
|
|
12.
|
Of these options, 40,000 were issued to a consultant and 403,334
were issued to employees of Amarin Neuroscience Limited
(formerly Laxdale Limited) on the date of acquisition by the
Company and become exercisable in tranches of 33% over three
years on the first, second and third anniversary of the date of
grant and expire 10 years from the date of the grant. Of
these options, 60,000 were immediately vested in June 2005 with
expiry dated 31 January 2007.
|
|
|
13.
|
These options were issued to employees of Amarin Neuroscience
Limited (formerly Laxdale Limited) on the date of acquisition by
the Company in consideration of the cancellation of a comparable
number of stock options (in value terms) previously held by
these employees in Amarin Neuroscience Limited. All these
options are fully vested. Of these options, 20,125 had an expiry
dated 31 January 2007.
|
|
|
14.
|
These options became exercisable on the date of grant and expire
10 years from the date of the grant.
|
F-50
|
|
|
|
15.
|
These options become exercisable, subject to performance
criteria, in tranches of 33% over three years on the first,
second and third anniversary of the date of grant and expire
10 years from the date of the grant.
|
|
|
16.
|
These options become exercisable in tranches of 50% on the
second anniversary, 25% on the third anniversary and 25% on the
fourth anniversary of the date of grant and expire 10 years
from the date of the grant.
|
|
|
17.
|
These options became exercisable on the date of grant and expire
4 years from the date of grant.
|
|
|
18.
|
These options became exercisable on the date of grant and expire
5 years from the date of grant.
|
|
|
19.
|
These options became exercisable on the date of grant and expire
on 31 March 2009.
|
|
|
20.
|
These options were granted prior to commencement of employment
and become exercisable in tranches of 33% over three years on
the first, second and third anniversary of the date of grant and
expire 10 years from the date of the grant.
|
Warrants
in shares of Amarin Corporation plc
At 31 December 2005, warrants have been granted over
ordinary shares as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price per
|
|
Number of warrants
outstanding
|
|
|
Note
|
|
|
Date warrant granted
|
|
ordinary share
|
|
|
|
313,234
|
|
|
|
1
|
|
|
27 January 2003
|
|
US$
|
3.48
|
|
|
500,000
|
|
|
|
2
|
|
|
25 February 2004
|
|
US$
|
1.90
|
|
|
9,135,034
|
|
|
|
3
|
|
|
21 December 2005
|
|
US$
|
1.43
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,948,268
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
During January 2003, via the private placement referred to in
note 30, 313,234 warrants were issued to Security Research
Associates Inc. and may be exercised between 27 January
2004 and 26 January 2008. |
|
(2) |
|
In February 2004, all debt obligations due to Elan were settled
by a cash payment of $17,195,000 (part of which represented the
cost of acquiring Zelapar that was concurrently sold to Valeant)
and the issuance of a loan note for $5,000,000 and 500,000
warrants granted to Elan at a price of $1.90 and exercisable
from 25 February 2004 to 25 February 2009. During
September 2004, Elan sold its remaining interests in Amarin to
Amarin Investment Holding Limited, an entity controlled by
Amarins non-executive Chairman, Mr Thomas Lynch. These
interests included Elans equity interest, the $5,000,000
loan note and the 500,000 warrants. |
|
(3) |
|
During December 2005, via the private placement referred to in
note 30, 9,135,034 warrants were issued to those investors
at a rate of approximately 35% of shares acquired. These
warrants were granted at a price of $1.43 and are exercisable
from 19 June 2006 to 21 December 2010. |
F-51
32. Share
premium account and reserves
Group
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital
|
|
|
|
|
|
Share
|
|
|
|
|
|
Profit and
|
|
|
|
|
|
|
redemption
|
|
|
Treasury
|
|
|
premium
|
|
|
Merger
|
|
|
loss
|
|
|
|
|
|
|
reserve
|
|
|
shares
|
|
|
account
|
|
|
reserve
|
|
|
account
|
|
|
Total
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
At 1 January 2003
|
|
|
|
|
|
|
|
|
|
|
61,146
|
|
|
|
(1,653
|
)
|
|
|
(84,758
|
)
|
|
|
(25,265
|
)
|
Premium on share issues
|
|
|
|
|
|
|
|
|
|
|
11,181
|
|
|
|
|
|
|
|
|
|
|
|
11,181
|
|
Share issuance costs
|
|
|
|
|
|
|
|
|
|
|
(2,104
|
)
|
|
|
|
|
|
|
|
|
|
|
(2,104
|
)
|
(Loss) for the year
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(19,248
|
)
|
|
|
(19,248
|
)
|
Release on disposal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,653
|
|
|
|
(1,653
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December 2003 and at
1 January 2004
|
|
|
|
|
|
|
|
|
|
|
70,223
|
|
|
|
|
|
|
|
(105,659
|
)
|
|
|
(35,436
|
)
|
Premium on share issues
|
|
|
|
|
|
|
|
|
|
|
17,805
|
|
|
|
|
|
|
|
|
|
|
|
17,805
|
|
Redemption of deferred shares
|
|
|
27,633
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
27,633
|
|
Share issuance costs
|
|
|
|
|
|
|
|
|
|
|
(953
|
)
|
|
|
|
|
|
|
|
|
|
|
(953
|
)
|
Profit for the year
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,655
|
|
|
|
4,655
|
|
Treasury shares
|
|
|
|
|
|
|
(217
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(217
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December 2004 and at
1 January 2005
|
|
|
27,633
|
|
|
|
(217
|
)
|
|
|
87,075
|
|
|
|
|
|
|
|
(101,004
|
)
|
|
|
13,487
|
|
Premium on share issues
|
|
|
|
|
|
|
|
|
|
|
40,966
|
|
|
|
|
|
|
|
|
|
|
|
40,966
|
|
Share issuance costs
|
|
|
|
|
|
|
|
|
|
|
(3,944
|
)
|
|
|
|
|
|
|
|
|
|
|
(3,944
|
)
|
Loss for the year
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(18,707
|
)
|
|
|
(18,707
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December
2005
|
|
|
27,633
|
|
|
|
(217
|
)
|
|
|
124,097
|
|
|
|
|
|
|
|
(119,711
|
)
|
|
|
31,802
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital
redemption reserve
On 21 June 2004, each of the issued ordinary shares of
£1 each was sub-divided and converted into one ordinary
share of £0.05 and one deferred share of £0.95.
Additionally, each authorized but unissued share of £1 each
was sub-divided into 20 ordinary shares of £0.05 each.
A fresh issue of one ordinary £0.05 share was made for
a consideration of £1. These proceeds were used by the
Company to purchase the deferred shares in issue. The deferred
shares were then cancelled by the Company and accordingly a
transfer was made for the amount of $27,633,000 to the capital
redemption reserve.
Treasury
shares
During October 2004, Amarin concluded the acquisition of
Laxdale. Laxdale has a shareholding in Amarin dating back to
November 2000. Under UITF 37 these shares are re-classified as
treasury shares from investments, where they are
recorded in Laxdales single entity financial statements,
and included as a deduction from shareholders funds. At
31 December 2005, Laxdale held 200,797 (2004: 200,797)
shares in Amarin. These shares are carried at the value as at
the date of acquisition, being the market value of
$1.08 per share and total carrying value of $217,000. The
nominal value of each share is £0.05.
Merger
reserve
The business combination of the Company and Gacell Holdings AB
was treated as a merger. The merger reserve arising on
consolidation consisted of the cost of the investment by the
Company in Gacell Holdings AB less the share capital of Gacell
Holdings AB. The merger reserve was released following the
disposal of the Gacell Holdings AB.
F-52
The cumulative value of goodwill written off to reserves up
until 31 December 2005, 2004 and 2003 was $3,007,000.
Company
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share
|
|
|
Capital
|
|
|
Profit
|
|
|
|
|
|
|
premium
|
|
|
redemption
|
|
|
and loss
|
|
|
|
|
|
|
account
|
|
|
reserve
|
|
|
account
|
|
|
Total
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
At 1 January 2003
|
|
|
58,420
|
|
|
|
|
|
|
|
(83,663
|
)
|
|
|
(25,243
|
)
|
Premium on share issue
|
|
|
11,181
|
|
|
|
|
|
|
|
|
|
|
|
11,181
|
|
Share issuance costs
|
|
|
(2,104
|
)
|
|
|
|
|
|
|
|
|
|
|
(2,104
|
)
|
(Loss) for the year
|
|
|
|
|
|
|
|
|
|
|
(31,254
|
)
|
|
|
(31,254
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December 2003 and at
1 January 2004
|
|
|
67,497
|
|
|
|
|
|
|
|
(114,917
|
)
|
|
|
(47,420
|
)
|
Premium on share issue
|
|
|
17,805
|
|
|
|
|
|
|
|
|
|
|
|
17,805
|
|
Share issuance costs
|
|
|
(953
|
)
|
|
|
|
|
|
|
|
|
|
|
(953
|
)
|
Redemption of deferred shares
|
|
|
|
|
|
|
27,633
|
|
|
|
|
|
|
|
27,633
|
|
Profit for the year
|
|
|
|
|
|
|
|
|
|
|
5,482
|
|
|
|
5,482
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December 2004 and at
1 January 2005
|
|
|
84,349
|
|
|
|
27,633
|
|
|
|
(109,435
|
)
|
|
|
2,547
|
|
Premium on share issue
|
|
|
40,966
|
|
|
|
|
|
|
|
|
|
|
|
40,966
|
|
Share issuance costs
|
|
|
(3,944
|
)
|
|
|
|
|
|
|
|
|
|
|
(3,944
|
)
|
Loss for the year
|
|
|
|
|
|
|
|
|
|
|
(9,163
|
)
|
|
|
(9,163
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At 31 December
2005
|
|
|
121,371
|
|
|
|
27,633
|
|
|
|
(118,598
|
)
|
|
|
30,406
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
33. Capital
commitments
Capital expenditure that has been contracted for but has not
been provided for in the financial statements amounted to $nil
at 31 December 2005 (31 December 2004: $nil,
31 December 2003: $nil).
34. Financial
commitments
The Group and Company had annual commitments under
non-cancellable operating leases as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
2004
|
|
2003
|
|
|
Land and buildings
|
|
Land and buildings
|
|
Land and buildings
|
|
|
Group
|
|
Company
|
|
Group
|
|
Company
|
|
Group
|
|
Company
|
|
|
$000
|
|
$000
|
|
$000
|
|
Expiring within one year
|
|
244
|
|
|
|
|
|
|
|
171
|
|
|
Expiring between two and five
years inclusive
|
|
250
|
|
250
|
|
810
|
|
537
|
|
|
|
|
Expiring in over five years
|
|
346
|
|
346
|
|
622
|
|
622
|
|
1,003
|
|
503
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
840
|
|
596
|
|
1,432
|
|
1,159
|
|
1,174
|
|
503
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-53
The other non-cancellable operating leases which existed at the
2003 year end were sold on 25 February 2004. Minimum
payments under non-cancellable operating leases for the next
five years are as set forth below:
|
|
|
|
|
|
|
|
|
|
|
Land and buildings
|
|
|
Land and buildings
|
|
|
|
Group
|
|
|
Company
|
|
|
|
$000
|
|
|
$000
|
|
|
2006
|
|
|
840
|
|
|
|
596
|
|
2007
|
|
|
596
|
|
|
|
596
|
|
2008
|
|
|
596
|
|
|
|
596
|
|
2009
|
|
|
596
|
|
|
|
596
|
|
2010
|
|
|
408
|
|
|
|
408
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,036
|
|
|
|
2,792
|
|
|
|
|
|
|
|
|
|
|
Minimum payments under non-cancellable operating leases for the
years 2011 and beyond are $972,000 (Company: $972,000) which are
for land and buildings.
On October 15, 2001 the Group acquired a six year lease,
with an option for a further six years, on office premises in
Mill Valley, San Francisco, California. In November 2005
management secured a Lease Termination Agreement that terminated
all interest and liability in this property effective
immediately.
On April 27, 2001 the Company acquired a nine year lease
for premises in London, UK. In prior years the rental was
£105,500 per annum (approximately $182,000). In
November 2005, the rental on these premises was subject to
review and was increased to £112,000 per annum
(approximately $193,000).
During 2005, Amarin Corporation plc opened an office in Dublin.
The lease for Dublin premises is still under negotiation and has
not been signed by Amarin Pharmaceuticals Ireland Limited. The
draft terms of the agreement comprise the rent of land and
buildings under an operating lease for 60,000 ($71,000)
per annum for the period until 30 June 2007. As there was
no commitment entered into by the Company at 31 December
2005, no amounts have been included in the operating lease
commitments table above.
Amarin Neuroscience Limited has annual commitments under
non-cancellable operating leases relating to land and buildings
which expire on 1 January 2007. The annual amount payable,
per annum for rent is £141,550 (approximately $244,000).
Amarin Neuroscience Limited has annual commitments under
non-cancellable operating leases relating to plant and machinery
which expire within two to five years. The annual amount
payable, per annum is £1,489 (approximately $2,500).
Following the acquisition of Laxdale Limited on 8 October
2004, further consideration may become payable upon marketing
approval being obtained for approval of products (covered by
Laxdales intellectual property) by the US Food and Drug
Administration (FDA) and European Medicines Agency
(EMEA) approval. The first approval obtained in the
US and Europe would result in additional consideration of
£7,500,000 payable, for each approval, to the vendors of
Laxdale Limited. The second approval obtained in the US and
Europe would result in additional consideration of
£5,000,000 payable, for each approval, to the vendors of
Laxdale Limited. Such additional consideration may be paid in
cash or shares at the sole option of each of the vendors (see
note 3).
35. Contingent
liabilities
The Group is not presently subject to any litigation.
F-54
36. Reconciliation
of net cash flow to movement in net funds/(debt)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Increase/(decrease) in cash in the
year
|
|
|
23,745
|
|
|
|
8,520
|
|
|
|
(22,168
|
)
|
Cash outflow from lease financing
|
|
|
8
|
|
|
|
|
|
|
|
|
|
Cash outflow from decrease in
borrowings
|
|
|
|
|
|
|
6,300
|
|
|
|
33,605
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in net funds resulting from
cash flows
|
|
|
23,753
|
|
|
|
14,820
|
|
|
|
11,437
|
|
Other non-cash items
|
|
|
2,000
|
|
|
|
27,098
|
|
|
|
7,496
|
|
Foreign exchange differences on
cash and borrowings
|
|
|
(827
|
)
|
|
|
372
|
|
|
|
|
|
New finance leases
|
|
|
(33
|
)
|
|
|
|
|
|
|
|
|
Disposal of finance leases
|
|
|
|
|
|
|
|
|
|
|
212
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Movement in net funds in the year
|
|
|
24,893
|
|
|
|
42,290
|
|
|
|
19,145
|
|
Net funds/(debt) at 1 January
|
|
|
8,989
|
|
|
|
(33,301
|
)
|
|
|
(52,446
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net funds/(debt) at
31 December
|
|
|
33,882
|
|
|
|
8,989
|
|
|
|
(33,301
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
37. Analysis
of net funds/(debt)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
|
|
|
|
|
|
|
|
|
Other
|
|
|
|
|
|
|
|
|
Other
|
|
|
|
|
|
|
At 31
|
|
|
|
|
|
non
|
|
|
At 31
|
|
|
|
|
|
non
|
|
|
At 31
|
|
|
|
|
|
non
|
|
|
At 31
|
|
|
|
December
|
|
|
Cash
|
|
|
cash
|
|
|
December
|
|
|
Cash
|
|
|
cash
|
|
|
December
|
|
|
Cash
|
|
|
cash
|
|
|
December
|
|
|
|
2002
|
|
|
flow
|
|
|
changes
|
|
|
2003
|
|
|
flow
|
|
|
changes
|
|
|
2004
|
|
|
flow
|
|
|
changes
|
|
|
2005
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Cash at bank and in hand
|
|
|
24,265
|
|
|
|
(22,168
|
)
|
|
|
|
|
|
|
2,097
|
|
|
|
8,520
|
|
|
|
372
|
|
|
|
10,989
|
|
|
|
23,745
|
|
|
|
(827
|
)
|
|
|
33,907
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt due after one year
|
|
|
(36,500
|
)
|
|
|
17,500
|
|
|
|
19,000
|
|
|
|
|
|
|
|
|
|
|
|
(2,000
|
)
|
|
|
(2,000
|
)
|
|
|
|
|
|
|
2,000
|
|
|
|
|
|
Debt due within one year
|
|
|
(39,999
|
)
|
|
|
16,105
|
|
|
|
(11,504
|
)
|
|
|
(35,398
|
)
|
|
|
6,300
|
|
|
|
29,098
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance leases due after one year
|
|
|
(193
|
)
|
|
|
|
|
|
|
193
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8
|
|
|
|
(19
|
)
|
|
|
(11
|
)
|
Finance leases due within one year
|
|
|
(19
|
)
|
|
|
|
|
|
|
19
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(14
|
)
|
|
|
(14
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(76,711
|
)
|
|
|
33,605
|
|
|
|
7,708
|
|
|
|
(35,398
|
)
|
|
|
6,300
|
|
|
|
27,098
|
|
|
|
(2,000
|
)
|
|
|
8
|
|
|
|
1,967
|
|
|
|
(25
|
)
|
Current asset investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
(52,446
|
)
|
|
|
11,437
|
|
|
|
7,708
|
|
|
|
(33,301
|
)
|
|
|
14,820
|
|
|
|
27,470
|
|
|
|
8,989
|
|
|
|
23,753
|
|
|
|
1,140
|
|
|
|
33,882
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The disposal of API in February 2004 generated cashflows to
enable Amarin to repay and restructure its debt as discussed
below, in note 38.
Movements in finance lease obligations in 2005 relate to a new
finance lease entered into by Amarin Neuroscience for plant and
machinery. Movements in finance lease obligations in 2003 relate
to those held by ADAB, which was sold in October 2003.
Neither the disposal of API nor the acquisition of Laxdale had
debt or finance leases associated with them and accordingly have
been excluded from the table above.
38. Major
non-cash transactions
In February 2004, debt obligations due to Elan were settled by a
cash payment of $17,195,000 (part of which represented the cost
of acquiring Zelapar that was concurrently sold to Valeant) and
the issuance of a loan note for $5,000,000 and 500,000 warrants.
Amarin recorded a total gain on settlement of Elan debt of
$24,608,000. The loan note carried interest at 8% per annum
and was repayable by installment (30% on 31 January 2006,
30% on 31 January 2007 and 40% on 31 January 2009).
During September 2004, Amarin reached agreement with Valeant to
settle a dispute following the disposal of our US operations and
certain product rights. It was agreed that Valeant
F-55
would pay Amarin, unconditionally $2,000,000 on 30 November
2004, of which $1,000,000 was paid to Elan. Amarin agreed to
waive rights to future income from Valeant of $3,000,000 (due on
successful completion of Zelapar safety studies) and $5,000,000
(due on approval by the US Food and Drug Administration). Also
during September 2004, Elan sold its remaining interests in
Amarin to Amarin Investment Holding Limited, an entity
controlled by Mr. Thomas Lynch, the non-executive Chairman
of Amarin. These interests included the $5,000,000 loan note and
500,000 warrants. During October 2004, Mr. Lynch redeemed
$3,000,000 of the loan note for 2,717,391 ordinary shares with
an option to redeem the remaining $2,000,000 at the offering
price of any future equity financing. AIHL redeemed the
remaining $2,000,000 of the loan note and subscribed for
1,538,461 ordinary shares as part of the registered direct
offering completed in May 2005.
At 31 December 2005, translation losses of $827,000 arise
on the translation of Amarin and Amarin Neuroscience
Limiteds sterling cash and overdraft balance.
At 31 December 2004, the non-cashflow impact of translation
gains of $409,000 on Amarins sterling cash balances held
less translation losses of $37,000 on Amarin Neuroscience
Limiteds sterling cash and overdraft balances gives rise
the net movement of $372,000.
Analysis
of movements on debt due within one year
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non cash
|
|
|
|
|
|
|
Cash movements
|
|
|
movements on
|
|
|
|
|
|
|
on Elan debt
|
|
|
Elan debt
|
|
|
|
2004
|
|
|
2004
|
|
|
2004
|
|
|
|
$million
|
|
|
$million
|
|
|
$million
|
|
|
Permax loan
|
|
|
25.0
|
|
|
|
|
|
|
|
|
|
Primary care portfolio (Carnrick)
loan
|
|
|
3.9
|
|
|
|
|
|
|
|
|
|
Carnrick loan
|
|
|
6.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amounts owed to Elan at
31 December 2003
|
|
|
35.4
|
|
|
|
|
|
|
|
|
|
New loans in January and February
2004 bridging finance
|
|
|
4.0
|
|
|
|
4.0
|
|
|
|
|
|
New loans in February
2004 Zelapar loan
|
|
|
7.9
|
|
|
|
7.9
|
|
|
|
|
|
Accrued interest
|
|
|
0.5
|
|
|
|
|
|
|
|
0.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amounts owed to Elan at
25 February 2004
|
|
|
47.8
|
|
|
|
|
|
|
|
|
|
Cash paid in
settlement 25 February 2004
|
|
|
(17.2
|
)
|
|
|
(17.2
|
)
|
|
|
|
|
Loan note issued in
settlement 25 February 2004
|
|
|
(5.0
|
)
|
|
|
|
|
|
|
(5.0
|
)
|
Cash paid in
settlement 1 December 2004
|
|
|
(1.0
|
)
|
|
|
(1.0
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain on settlement of amounts owed
to Elan
|
|
|
24.6
|
|
|
|
|
|
|
|
(24.6
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6.3
|
)
|
|
|
(29.1
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During 2003, the Group obtained a waiver of $7,500,000 against
non-interest bearing debt owed to Elan, a related party.
During 2003, the remaining 2,000,000 preference shares were
converted into 2,000,000 ordinary shares of £1 each.
39. Pensions
The Group operates a number of defined contribution money
purchase pension schemes for certain eligible employees. The
assets of the schemes are held separately from those of the
Group in independently administered funds. The pension cost
charge represents contributions paid and payable by the Group to
the fund and amounted to $244,000 (year to 31 December
2004: $111,000 year to 31 December 2003: $160,000). At
the year end there was a liability of $nil (31 December
2004: liability of $nil, 31 December 2003: liability of
$5,000).
F-56
40. Post
balance sheet events
On 23 January 2006, the Company issued a total of 840,000
ordinary £0.05 shares as follows:
|
|
|
|
|
800,000 shares in consideration for $2,000,000 (nominal
value of $71,000) raised in the 23 January 2006 private
equity placement, the proceeds of which will be used to fund the
combined operations of Amarin and Amarin Neuroscience
Limited; and
|
|
|
|
40,000 shares in consideration for $100,000 (nominal value
of $4,000) raised in the 23 January 2006 private equity
placement, the proceeds of which will be used to fund the
combined operations of Amarin and Amarin Neuroscience Limited.
|
In January 2006, the Company issued 295,529 shares due to
the exercise of share options of nominal value $26,000 in
aggregate for a total consideration of $828,000. In February
2006, the Company issued 240,298 shares due to the exercise
of share options of nominal value $21,000 in aggregate for a
total consideration of $837,000. In March 2006, the Company
issued 5,000 shares due to the exercise of share options of
nominal value $1,000 in aggregate for a total consideration of
$18,000.
41. Related
party transactions
A. Elan
and Amarin Investment Holding Limited
During the years ended 31 December 2004 and 2003, Amarin
entered into certain contracts, and varied the terms of other
contracts, with Elan which was a related party at the time such
transactions were entered into but is no longer so, and Amarin
Investment Holding Limited which is a significant shareholder
and an entity controlled by Amarins Chairman,
Mr. Thomas Lynch. The directors consider that transactions
with Elan and Amarin Investment Holding Limited were entered
into on an arms length basis. Details of such transactions
(together with certain historical detail for reference purposes)
involving Elan are given below.
(a) Permax
On 29 May 2001 the Board of Directors approved a
Distribution, Marketing and Purchase Option Agreement with Elan
relating to the Parkinsons disease product, Permax. This
was amended and restated on 28 September 2001, (the
Permax Agreement) and gave the Company the exclusive
US marketing, distribution and purchase option rights to this
product.
Under the Permax Agreement, the Company was appointed exclusive
US distributor for Permax until 16 May 2002, with an option
to acquire Elans continuing rights in the product. As a
part of the Permax Agreement the Company made payments of
$47,500,000 to Elan in consideration for the rights and purchase
option with a further $37,500,000 payable by way of deferred
consideration over the course of the following three years (the
Deferred Consideration).
The Company also agreed to pay Elan royalties on Permax sales.
As part of the transaction, the Company received a loan from
Elan for the amount of $45,000,000, which matured in September
2002 (the Elan Loan).
In March 2002, Amarin exercised its purchase option under the
Permax Agreement to acquire, and completed the acquisition of,
the remaining US rights to Permax from Elan. Following the close
of the transaction, Amarin replaced Elan as Eli Lillys
exclusive licensee for Permax in the US.
In July 2002, Amarin restructured for the first time the Elan
Loan originally scheduled for repayment in full on
30 September 2002. Under the revised payment schedule, the
Elan Loan was to be repaid in four instalments of $2,500,000,
$17,500,000, $10,000,000 and $15,000,000, beginning in the third
quarter of 2002.
(b) Zelapar
In May 2001, Amarin paid a non-refundable option fee of $100,000
to acquire the US rights to Zelapar from Elan (the Zelapar
Agreement). The option to acquire the US rights to Zelapar
was exercisable at any time up to 30 days after FDA
approval of the NDA for Zelapar. The Zelapar Agreement required
us to make four milestone payments of up to $42,500,000 plus
running royalties based on a percentage of net sales of Zelapar
in the US for the
F-57
first eight years following exercise. Elan was obliged at this
time to pay all research and development costs including filing
costs for the NDA up to and including approval of the NDA by the
FDA.
(c) Elan
Equity Stake in Amarin
In March 2002, Elan converted 2,129,819 Preference Shares into
an equivalent number of Ordinary Shares. Effective February
2003, Elan converted its remaining 2,000,000 Preference Shares
into 2,000,000 Ordinary Shares. Elan had the right to include
these Ordinary Shares, together with its remaining 2,653,819
Ordinary Shares and ADSs, in a registration statement filed by
us.
Elan agreed with us that, until 1 October 2003, it would
not sell, transfer or otherwise dispose of any of the Ordinary
Shares, ADSs or Preference Shares held by it, provided that Elan
would not have been prevented from:
|
|
|
|
|
converting Preference Shares into Ordinary Shares;
|
|
|
|
accepting any offer made to all holders of our Ordinary Shares
to acquire all or part of our issued Ordinary Share capital;
|
|
|
|
transferring any securities to a subsidiary or holding company
of such shareholder; or
|
|
|
|
selling Ordinary Shares or ADSs where the purchaser entered into
a written agreement confirming its intention to hold such
Ordinary Shares for a period ending not earlier than
30 September 2003 and the per share sale price of such
Ordinary Shares was not less than 90% of the closing sale price
of our ADSs on the NASDAQ National Market for the five
trading days immediately prior to the date of such sale.
|
Elan had additional registration rights which were based on
rights it acquired in 1998. These included the right to demand
further registrations of its Ordinary Shares and ADSs. Such a
registration would, at Elans request, have involved an
underwritten offering, which Elan could have commenced at any
time after 1 January 2004 if it included in such offering
at least 1,000,000 Ordinary Shares and ADSs and determined in
good faith that such an underwritten offering was in its best
economic interest.
(d) January
2003 Restructuring of Elan Obligations
In conjunction with the closing of the private placement on
27 January 2003, Amarin again restructured certain of the
debt and milestone payments due or potentially due to, and
certain of our contractual obligations with, Elan as indicated
below:
(i) Elan Loan
Amarin paid $2,459,880 in cash out of cash reserves to Elan as
interest accrued on the Elan Loan to 16 January 2003. The
Elan Loan was varied so that the instalments were rescheduled as
follows:
|
|
|
|
|
the $10,000,000 due and payable on 30 September 2003,
together with accrued interest, became due and payable on
30 September 2004; and
|
|
|
|
the $15,000,000 due and payable on 30 September 2004,
together with accrued interest, became due and payable on
30 September 2005.
|
In accordance with the terms of the Elan Loan, on
16 January 2003 Amarin paid $17,500,000 to Elan that was
previously due on 31 December 2002.
(ii) Permax
Amarin paid $8,641,387 to Elan in discharge of the current
outstanding balance relating to Permax inventory, royalties and
a $2,500,000 quarterly instalment of Deferred Consideration.
The Permax Agreement was amended so that the Deferred
Consideration was reduced by $7,500,000.
F-58
(iii) Zelapar
The Zelapar Agreement was amended so that the first sales
milestone payable by us to Elan became $17,500,000 rather than
$12,500,000. Amarin also agreed to pay approved reasonable and
verifiable
out-of-pocket
costs incurred by Elan after 31 December 2002 in respect of
any further development costs incurred for Zelapar.
(iv) General
Amarin undertook to use its commercial best efforts (subject to
the fiduciary obligations of our board of directors) to sell all
or substantially all of the Primary Care Portfolio and Amarin AB
for upfront cash consideration of a reasonable sum and as
expeditiously as was reasonably practicable. Amarin agreed with
Elan to apply the net proceeds from such sale or sales as
follows:
|
|
|
|
|
$5,000,000 would have been payable to Elan, which amount would,
if paid, have been credited against the first sales milestone
for Zelapar which was $17,500,000 as referred to above;
|
|
|
|
prepayment of the remaining Deferred Consideration due under the
Permax Agreement;
|
|
|
|
prepayment of the $6,500,000 loan due to Elan relating to the
Carnrick group of products acquired from Elan in September 1999
and due in September 2004 (the Carnrick Loan);
|
|
|
|
prepayment of all sums then due under the Elan Loan;
|
|
|
|
payment of any additional amounts due to Elan; and
|
|
|
|
if there is any remainder, applied in our sole discretion.
|
Elan had the right, at its sole discretion, to redirect the
order in which the net proceeds of any such sales were applied
as between the uses set out above. Additionally, after having
paid the first $35,000,000 of the net proceeds of any sale in
the manner set out above, Amarin could at its option have
deferred payment of 50% of any balance due to Elan for a period
of six months from the closing of such sale or sales.
Amarin also agreed with Elan that if at any time and from time
to time prior to our payment in full of the balance of the
non-refundable sum of $30,000,000 due to Elan for the
acquisition of Permax, the Carnrick Loan and the Elan Loan, it
received financing relating to the issuance of equity
securities, warrants to acquire equity securities or debt
convertible into equity securities, the company would apply
one-half of the net proceeds of such financing toward the
payment of such obligations.
(e) August
2003 Restructuring of Elan Obligations
In August 2003, Amarin agreed with Elan as part of a
comprehensive settlement of its debt obligations to Elan:
|
|
|
|
|
to pay $30,000,000 in cash no later than 31 December 2003;
|
|
|
|
to pay $10,000,000 in equity when Zelapar annual sales reach
$20,000,000;
|
|
|
|
to continue to pay a 12.5% royalty on future sales of
Zelapar; and
|
|
|
|
in the event that the Company raised funds in excess of
$40,000,000 from the disposal of non-core assets and/or
financing, the company agreed to use half the excess to reduce
the existing Zelapar royalty of 12.5% at the rate of one-half of
one percent for each $1 million per half of 1%, up to a
maximum of 5%.
|
In consideration for the foregoing, Elan agreed to:
|
|
|
|
|
a moratorium on debt and interest payments until
31 December 2003;
|
|
|
|
full and final settlement of all the Elan Loan, the Carnrick
Loan and the Deferred Consideration;
|
|
|
|
elimination of existing option and milestone payments relating
to Zelapar;
|
|
|
|
in connection with this agreement Amarin granted to Elan a fixed
and floating charge over all of its assets, to be reduced to
$5,000,000 upon payment of the $30,000,000 no later than the
year-end.
|
F-59
(f) December
2003 Restructuring of Elan Obligations
In December 2003, the Company agreed with Elan that, if the
$30,000,000 minimum payment was not made by 31 December
2003, the year-end deadline for debt repayment could be extended
to 31 March 2004 in consideration of the payment to Elan of
interest (calculated at 1% per month on the outstanding
balance) and a one-off payment to Elan of $1,500,000. Elan also
agreed that the Company could retain a further
$2,000,000 per month for the first three months of 2004
from the net proceeds from the sale of ADAB in order to fund the
Companys operating deficit through the first quarter of
2004. Draw down of these funds was subject to the Company
demonstrating to Elans satisfaction that the Company has a
reasonable prospect of consummating a transaction to settle the
Elan debt by 31 March 2004.
(g) Sale
of API/February 2004 Restructuring of Elan Obligations
Simultaneously with the closing of the asset purchase agreement
with Valeant Pharmaceuticals International
(Valeant), Amarin reached a full and final agreement
with Elan regarding the settlement of the renegotiated
outstanding financial obligations. Under the terms of this
agreement with Elan, the amount of $24,400,000 then required to
discharge the companys obligations to Elan was amended so
that it would pay Elan approximately $17,195,000 in cash on
closing of the Valeant transaction, plus a further payment of
$1,000,000 on the successful completion of the Zelapar safety
trials to discharge these obligations.
Amarin also issued a $5,000,000
5-year loan
note to Elan with capital repayment as follows:
|
|
|
|
|
$1,500,000 in January 2006;
|
|
|
|
$1,500,000 in July 2007; and
|
|
|
|
$2,000,000 in January 2009.
|
At Elans option, the loan note could have been repaid from
proceeds Amarin were due to receive from a
$5,000,000 milestone payable by Valeant on the NDA approval
of Zelapar. The loan note was also prepayable by Amarin at any
time, subject to a prepayment fee of $250,000, and carried an
interest rate of 8% per annum.
Additionally, the company agreed to issue 500,000 warrants to
Elan priced at the average market closing price for the Ordinary
Shares for the
30-day
period prior to closing. As a result, Elans fully diluted
ownership in Amarin increased at that time from 25.9% to 28.0%.
Amarin closed the Valeant transaction on February 25, 2004.
From the proceeds of this sale the company made a payment to
Elan of approximately $17.2 million in partial payment of
outstanding indebtedness and entered into the various agreements
and instruments set out above.
On September 30, 2004 Amarin Investment Holding Limited
declared an interest to Amarin in the following securities in
Amarin following their purchase from Elan Corporation plc and
its affiliated companies:
|
|
|
|
|
4,653,819 ADSs;
|
|
|
|
Warrants to subscribe for 500,000 Ordinary Shares at an exercise
price of US$1.90 per share; and
|
|
|
|
US$5 million in aggregate principal amount of Secured Loan
Notes due 2009, issued pursuant to a loan note instrument dated
February 25, 2004.
|
The Board of Directors of Amarin reviewed and approved this
transaction after consultation with certain of its advisors.
Following its acquisition of equity and debt securities of
Amarin from Elan Corporation plc, Amarin Investment Holding
Limited redeemed $3 million of the $5 million in
principal amount of loan notes acquired by it for 2,717,391
ordinary shares of Amarin on October 7, 2004. The debt was
redeemed at a price of $1.104 per share. This transaction
was reviewed by Amarins Audit Committee and approved by
our disinterested directors. The shares issued pursuant to such
debt conversion was subject to a lockup agreement restricting
their sale for a period of six months from October 7, 2004.
The remaining $2 million in principal amount of the loan
notes was payable in January 2009, and interest thereon accrued
at the rate of 8% per annum and was payable on a
semi-annual
F-60
basis. Amarin Investment Holding Limited had the option, to
redeem such remaining principal amount for ordinary shares at
the offering price established by the Company pursuant to any
equity financing in excess of $5 million that the company
was conducted in the future, subject to the review of
Amarins Audit Committee and approval of Amarins
disinterested directors. AIHL as part of the registered direct
offering completed in May 2005, redeemed the remaining
$2,000,000 of the loan note and subscribed for 1,538,461
ordinary shares.
As a result of the above Elan was no longer a related party as
at September 30, 2004.
B.
Directors Investment in Registered Direct Offering and Private
Placement
Several of the Companys directors and officers (including
Dr. Climax) subscribed for approximately 6,900,000 ordinary
shares in the May and December 2005 offering (including
1,538,461 ordinary shares issued to AIHL set out in
note 30).
C.
Icon
At December 31, 2005 Sunninghill Limited, a company
controlled by Dr. John Climax, held 6.3 million shares
and 0.2 million warrants in Amarin (which was approximately
8% of Amarins entire issued share capital) and Raphoe
Limited, a company controlled by Dr. Climax, held
approximately 27% of Icon plc. During the year the Company
entered into an agreement with Icon Clinical Research Limited (a
company wholly owned by Icon Plc) whereby Icon were appointed as
Amarins contract research organization to manage and
oversee its European phase II study on Miraxion (Trend
2) and to assist Amarin in conducting its
U.S. phase III on Miraxion (Trend 1). At
December 31, 2005 Amarin had incurred costs of
$2.4 million with respect to Icon. At the year end,
£0.8m ($1.36m) is included in accruals.
Our Chairman Tom Lynch has served as an outside director of Icon
since January 1996. He is also a member of the Icon audit
committee. On March 20, 2006 Dr. Climax subsequently
became a non-executive director of the Company.
D.
Approval of related party transactions
All of the above transactions were approved in accordance with
our policy for related party transactions. Our policy in 2004
and 2005 was to require Audit Committee review and approval of
all transactions involving a potential conflict of interest,
followed by the approval of the Audit Committee or of a majority
of the board of directors who do not have a material interest in
the transaction.
In March 2006, our remuneration committee reviewed and approved
a consultancy agreement between the Company and Dalriada Limited
in relation to the provision by Dalriada Limited to the Company
of corporate consultancy services, including consultancy
services relating to financing and other corporate finance
matters, investor and media relations and implementation of
corporate strategy. Under the Consultancy Agreement, the Company
will pay Dalriada Limited a fee of STG£240,000 per annum
for the provision of the consultancy services. Dalriada Limited
is owned by a family trust, the beneficiaries of which include
Mr. Thomas Lynch and family members.
E.
Transactions between Group companies
The Company has taken advantage of the exemption in FRS 8
Related Party Disclosures not to disclose
information relating to transactions between Group companies at
31 December 2005.
Prior to the acquisition of Laxdale on 8 October 2004, the
Company funded Laxdales working capital. Amarin commenced
funding on 7 June 2004 and as at the date of acquisition,
Amarin had advanced $1.86 million including interest
($0.03 million), charged at standard commercial rates on an
arms length basis.
Laxdale Ltd has a licence agreement with Scarista Ltd whereby
rights to develop products using Scaristas intellectual
property and know-how has been licensed to Laxdale Ltd. Scarista
Ltd is ultimately owned by a family trust, the beneficiaries of
which were Dr D F Horrobin and is S M Clarkson. Dr D F Horrobin
was a director of Laxdale Limited until his death on
1 April 2003 and SM Clarkson was a director of Laxdale
until she resigned on
F-61
8 October 2004. Under the licence agreement Laxdale has the
right to develop and market products in specified territories.
In return for the rights granted to it, Laxdale will make
royalty payments to Scarista Ltd based on income from sales of
products at normal commercial rates. In addition Scarista has a
license agreement with Laxdale Ltd whereby rights to market and
sell products using Laxdales intellectual property and
know-how have been licensed to Scarista Ltd. Under the license
agreement Scarista has the right to market products in specified
territories. In return for the rights granted to it, Scarista
will make royalty payments to Laxdale Ltd based on the income it
receives from commercializing the products at normal commercial
rates. Under both licences Scarista and Laxdale are responsible
for the prosecution and maintenance costs of the patents
relating to their respective territories licensed to them. For
administrative reasons these are paid by Scarista and recharged
to Laxdale. For the pre-acquisition period from 1 April
2004 to 8 October 2004, Scarista Limited paid patent fees
totaling £98,481 ($177,807). For the pre-acquisition period
for the year ended 31 March 2004 Scarista paid patent fees
totaling £231,324 ($394,431) (2003: £177,980
($285,195)), which were recharged to Laxdale Ltd in accordance
with the license agreements. No other transactions under the
license agreements took place during the year ended
31 March 2004 (2003: nil).
Subsequent to the acquisition by Amarin, Laxdale entered into
re-negotiated cross-licensing agreements with Scarista Limited
which provide Laxdale with rights to specified intellectual
property covering the United States, Canada, the European Union
and Japan. Scarista has granted a license to Laxdale pursuant to
which Laxdale has the exclusive right to market, sell and
distribute products utilizing certain of Scaristas
intellectual property (including intellectual property for the
use of Miraxion in drug-resistant depression) within a field of
use encompassing all psychiatric and central nervous system
disorders, and within the territories of the United States,
Canada, the European Union and Japan. As part of such
re-negotiation Scarista is entitled to receive reduced royalty
payments of 5% on all net sales by Laxdale of products utilizing
such Scarista intellectual property and certain of
Laxdales intellectual property (which intellectual
property had been transferred to Laxdale by Scarista in March,
2000). In consideration of Scarista entering into these
agreements and the reduction of Scaristas royalty from 15%
to 5%, Laxdale paid a signing fee of £500,000 ($891,000) to
Scarista. The Scarista intellectual property licensed to Laxdale
is material to Amarins development efforts with respect to
Miraxion. In addition, Laxdale granted a license to Scarista
pursuant to which Scarista has the exclusive right to market,
sell and distribute products utilizing certain of Laxdales
intellectual property (including intellectual property for the
use of Miraxion in Huntingtons disease) within a field of
use encompassing all psychiatric and central nervous system
disorders, and on a worldwide basis in all territories other
than the United States, Canada, the European Union and Japan.
Laxdale is entitled to receive royalty payments of 5% on all net
sales by Scarista or its licensees of products utilizing such
Laxdale intellectual property. Under each of these license
agreements royalties are payable until the latest to occur of
(i) the expiration of the last patent relating to any
product using the licensed technology, (ii) the expiration
of regulatory exclusivity with respect to any product using the
licensed technology, or (iii) the date on which the
licensed technology ceases to be secret and substantial in a
given territory. Upon the termination of royalty payment
obligations with respect to any product, the licensee will
thereafter have a fully paid up, royalty free, non-exclusive
license to continue using the licensed technology in respect of
such product.
There were no patent fees recharged from Scarista to Laxdale
during the post acquisition period to 31 December 2005
(2004: nil) and no balance remained outstanding between Scarista
and Laxdale at 31 December 2005 (2004: nil).
F-62
42. Differences
between UK GAAP and US GAAP
The financial statements of the Group have been prepared in
conformity with UK GAAP which differs in certain significant
respects from generally accepted accounting principles in the US
(US GAAP). These differences have a significant
effect on net income and the composition of shareholders
equity and are described below.
Summary
of adjustments to net profit/(loss) and shareholders
equity/(deficit)
1. Net
(loss)/profit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended
|
|
|
Year ended
|
|
|
Year ended
|
|
|
|
|
|
|
31 December
|
|
|
31 December
|
|
|
31 December
|
|
|
|
Note
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Net (loss)/profit in accordance
with UK GAAP
|
|
|
|
|
|
|
(18,707
|
)
|
|
|
4,012
|
|
|
|
(19,224
|
)
|
Adjustment for gain on securities
held for trading
|
|
|
C
|
|
|
|
3
|
|
|
|
5
|
|
|
|
9
|
|
Adjustment for stock-based
compensation and National Insurance
|
|
|
F
|
|
|
|
(17
|
)
|
|
|
32
|
|
|
|
(50
|
)
|
Adjustment for treatment of
intangible fixed assets
|
|
|
J
|
|
|
|
675
|
|
|
|
(47,530
|
)
|
|
|
576
|
|
Adjustment for revenue recognition
|
|
|
K
|
|
|
|
(500
|
)
|
|
|
617
|
|
|
|
|
|
Gain on settlement/renegotiation
of related party liability
|
|
|
L
|
|
|
|
|
|
|
|
(24,608
|
)
|
|
|
(7,500
|
)
|
Imputed interest on non-interest
bearing debt
|
|
|
M
|
|
|
|
|
|
|
|
|
|
|
|
(449
|
)
|
Adjustment for revenue recognition
|
|
|
O
|
|
|
|
|
|
|
|
|
|
|
|
348
|
|
Adjustment to Permax purchase
consideration
|
|
|
P
|
|
|
|
|
|
|
|
|
|
|
|
(2,146
|
)
|
Discount on loan note
|
|
|
R
|
|
|
|
(369
|
)
|
|
|
(20
|
)
|
|
|
|
|
Vacation accrual
|
|
|
S
|
|
|
|
(43
|
)
|
|
|
(12
|
)
|
|
|
|
|
Adjustment for use of temporal
method on consolidation
|
|
|
U
|
|
|
|
(939
|
)
|
|
|
302
|
|
|
|
|
|
Restructuring
provision staff redundancy costs
|
|
|
V
|
|
|
|
80
|
|
|
|
|
|
|
|
|
|
Property costs
|
|
|
W
|
|
|
|
187
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) as adjusted to US GAAP
|
|
|
|
|
|
|
(19,630
|
)
|
|
|
(67,202
|
)
|
|
|
(28,436
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
US GAAP net (loss) per ordinary
share (assuming dilution)
|
|
|
|
|
|
|
(0.42
|
)
|
|
|
(2.99
|
)
|
|
|
(1.66
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
US GAAP net (loss) per ordinary
share (basic)
|
|
|
|
|
|
|
(0.42
|
)
|
|
|
(2.99
|
)
|
|
|
(1.66
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
US GAAP net (loss) on continuing
activities per ordinary share (assuming dilution)
|
|
|
|
|
|
|
(0.42
|
)
|
|
|
(2.85
|
)
|
|
|
(1.36
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
US GAAP net (loss) on continuing
activities per ordinary share (basic)
|
|
|
|
|
|
|
(0.42
|
)
|
|
|
(2.85
|
)
|
|
|
(1.36
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31 December
|
|
|
31 December
|
|
|
31 December
|
|
|
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
Note
|
|
|
Number
|
|
|
Number
|
|
|
Number
|
|
|
|
|
|
|
000
|
|
|
000
|
|
|
000
|
|
|
Shares used in computing per
ordinary share amounts assuming dilution
|
|
|
I
|
|
|
|
46,590
|
|
|
|
22,511
|
|
|
|
17,440
|
|
Shares used in computing per basic
ordinary share amounts
|
|
|
I
|
|
|
|
46,590
|
|
|
|
22,511
|
|
|
|
17,093
|
|
F-63
2. Shareholders
equity/(deficit)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended
|
|
|
Year ended
|
|
|
Year ended
|
|
|
|
|
|
|
31 December
|
|
|
31 December
|
|
|
31 December
|
|
|
|
Note
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Shareholders
equity/(deficit) in accordance with UK GAAP
|
|
|
|
|
|
|
38,580
|
|
|
|
16,693
|
|
|
|
(6,348
|
)
|
Adjustment for gain on securities
held for trading
|
|
|
C
|
|
|
|
24
|
|
|
|
21
|
|
|
|
16
|
|
Adjustment for National Insurance
on stock options
|
|
|
F
|
|
|
|
15
|
|
|
|
32
|
|
|
|
|
|
Adjustment for treatment of
intangible fixed assets
|
|
|
J
|
|
|
|
(9,627
|
)
|
|
|
(10,302
|
)
|
|
|
(4,149
|
)
|
Adjustment for revenue recognition
|
|
|
K
|
|
|
|
(500
|
)
|
|
|
|
|
|
|
(617
|
)
|
Adjustment for preferred dividend
|
|
|
N
|
|
|
|
|
|
|
|
|
|
|
|
546
|
|
Discount on loan note
|
|
|
R
|
|
|
|
|
|
|
|
369
|
|
|
|
|
|
Vacation accrual
|
|
|
S
|
|
|
|
(78
|
)
|
|
|
(35
|
)
|
|
|
|
|
Adjustment for acquisition
accounting
|
|
|
T
|
|
|
|
(41,354
|
)
|
|
|
(41,354
|
)
|
|
|
|
|
Adjustment for use of temporal
method on consolidation
|
|
|
U
|
|
|
|
(7
|
)
|
|
|
(17
|
)
|
|
|
|
|
Restructuring
provision staff redundancy costs
|
|
|
V
|
|
|
|
80
|
|
|
|
|
|
|
|
|
|
Property costs
|
|
|
W
|
|
|
|
187
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders (deficit) in
accordance with US GAAP
|
|
|
|
|
|
|
(12,680
|
)
|
|
|
(34,593
|
)
|
|
|
(10,552
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A. Disclosures
related to deferred taxes
Management of the Group evaluated the positive and negative
evidence impacting the realizability of the Groups net
operating loss carryforwards. Due to the Groups history of
generating operating losses, significant changes in its
underlying products offering and limited periods of
profitability, management concluded that a full valuation
allowance is required with respect to its net operating loss
carryforwards other than as explained in note 15. Following
the introduction of FRS19 Deferred Tax, UK GAAP is
now similar to existing US GAAP in this area.
Under UK GAAP, provision is made for deferred tax liabilities
and assets, using full provision accounting when an event has
taken place by the balance sheet date which gives rise to an
increased or reduced tax liability in the future in accordance
with FRS19. Deferred tax is measured at the average tax rates
that are expected to apply in the periods in which the timing
differences are expected to reverse based on tax rates and laws
that have been enacted or substantially enacted by the balance
sheet date. Deferred tax is measured on a non-discounted basis.
Deferred tax assets are recognised to the extent that they are
regarded as recoverable.
Under US GAAP, deferred tax is recognised in full in respect of
temporary differences between the reported carrying amount of an
asset or liability and its corresponding tax basis. Deferred tax
assets are also recognised in full subject to a valuation
allowance to reduce the amount of such assets to that which is
more likely than not to be realized.
B. Adjustment
for change in functional and reporting currency and discontinued
operations
On 1 January 2003, the functional and reporting currency
for the Group was changed to US dollars from sterling pounds.
Under UK GAAP, the comparative amounts as of 31 December
2002, which had historically been reported in sterling, were
recalculated as if converted at the 31 December 2002
closing rate of $1.6099.
F-64
Set out below are the profit and loss accounts for the years
ended 31 December 2005, 2004 and 2003, showing continuing
and discontinued operations on the US GAAP basis. Discontinued
operations comprise the disposal of Amarin Pharmaceuticals Inc,
in February 2004 and the disposal of Amarin Development (Sweden)
AB in October 2003, together with residual items relating to
those disposals. The remaining items shown in Table 1 Net
(loss)/profit above need to be added to these profit and
loss accounts to arrive at the net loss in accordance with US
GAAP.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Turnover
|
|
|
500
|
|
|
|
|
|
|
|
|
|
Cost of sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
500
|
|
|
|
|
|
|
|
|
|
Operating expenses
|
|
|
(19,408
|
)
|
|
|
(9,927
|
)
|
|
|
(6,200
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
|
(18,908
|
)
|
|
|
(9,927
|
)
|
|
|
(6,200
|
)
|
Interest receivable and similar
income
|
|
|
395
|
|
|
|
548
|
|
|
|
65
|
|
Interest payable and similar
charges
|
|
|
(892
|
)
|
|
|
(326
|
)
|
|
|
(900
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations
before income taxes
|
|
|
(19,405
|
)
|
|
|
(9,705
|
)
|
|
|
(7,035
|
)
|
Income
taxes credit/(charge)
|
|
|
698
|
|
|
|
(7,333
|
)
|
|
|
7,356
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss)/income from continuing
operations
|
|
|
(18,707
|
)
|
|
|
(17,038
|
)
|
|
|
321
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from discontinued operations
|
|
|
|
|
|
|
(1,165
|
)
|
|
|
(32,621
|
)
|
Gain on disposal of discontinued
operations
|
|
|
|
|
|
|
22,215
|
|
|
|
13,076
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net profit/(loss) from
discontinued operations
|
|
|
|
|
|
|
21,050
|
|
|
|
(19,545
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss)/profit
|
|
|
(18,707
|
)
|
|
|
4,012
|
|
|
|
(19,224
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss)/income on continuing
activities per ordinary share (assuming dilution)
|
|
|
$(0.40
|
)
|
|
|
$(0.76
|
)
|
|
|
$0.02
|
|
Net (loss)/income on continuing
activities per ordinary share (basic)
|
|
|
$(0.40
|
)
|
|
|
$(0.76
|
)
|
|
|
$0.02
|
|
Net (loss) on discontinued
activities per ordinary share (assuming dilution)
|
|
|
$
|
|
|
|
$0.94
|
|
|
|
$(1.14
|
)
|
Net income/(loss) on discontinued
activities per ordinary share (basic)
|
|
|
$
|
|
|
|
$0.94
|
|
|
|
$(1.14
|
)
|
On the face of the UK GAAP profit and loss account are certain
items which are disclosed as exceptional. Under US GAAP these
items would not represent extraordinary items and would,
therefore, not be disclosed separately.
C. Treatment
of securities held for trading
Under UK GAAP investments (including listed investments) held on
a current or long-term basis are stated at the lower of cost or
estimated fair value, less any permanent diminution in value.
Under US GAAP the carrying value of our marketable equity
securities is adjusted to reflect unrealized gains and losses
resulting from movements in the prevailing market value. During
2002, the value of our current asset investments was written off
to zero under UK GAAP but continues to be marked to the current
market value under US GAAP.
Under US GAAP the fair value of current asset investments was
$24,000, $21,000, and $16,000 for the periods ended
31 December 2005, 2004 and 2003, respectively.
D. Consolidated
statement of cash flows
The consolidated statement of cash flows has been prepared in
accordance with UK GAAP, FRS 1 Cashflow Statements
and presents substantially the same information as that required
under US GAAP. Under US GAAP,
F-65
however, there are certain differences from UK GAAP with regard
to classification of items within the cash flow statement.
Under UK GAAP, cash flows are presented separately for operating
activities, returns on investments and servicing of finance,
taxation, capital expenditure and financial investment,
acquisitions and disposals, management of liquid resources and
financing activities. Under US GAAP, however, only three
categories of cash flow activity are reported, being operating
activities, investing activities and financing activities. Cash
flows from taxation and payments for interest would be included
as operating activities under US GAAP. The financing proceeds
and debt repayments would be included under financing activities
under US GAAP. Additionally the cashflow represents only the
change in cash and cash equivalents (which would exclude
overdrafts) under US GAAP.
Set out below, for illustrative purposes, is a summary
consolidated statement of cash flows under US GAAP:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended
|
|
|
Year ended
|
|
|
Year ended
|
|
|
|
31 December
|
|
|
31 December
|
|
|
31 December
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Net cash (used in)/provided by
operating activities
|
|
|
(18,133
|
)
|
|
|
(10,355
|
)
|
|
|
(20,504
|
)
|
Net cash provided by/(used in)
investing activities
|
|
|
(135
|
)
|
|
|
13,726
|
|
|
|
(3,060
|
)
|
Net cash provided by/(used in)
financing activities
|
|
|
41,186
|
|
|
|
5,521
|
|
|
|
1,396
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase/(decrease) in cash
and cash equivalents
|
|
|
22,918
|
|
|
|
8,892
|
|
|
|
(22,168
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at the
beginning of the year
|
|
|
10,989
|
|
|
|
2,097
|
|
|
|
24,265
|
|
Cash and cash equivalents at the
end of the year
|
|
|
33,907
|
|
|
|
10,989
|
|
|
|
2,097
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase/(decrease) in cash
and cash equivalents
|
|
|
22,918
|
|
|
|
8,892
|
|
|
|
(22,168
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In 2005, the effect of foreign exchange movements on cash
balances was $827,000 (2004: $372,000), which is included above.
There was no significant effect of foreign exchange movements on
cash balances in 2003.
Where applicable, short-term highly liquid investments which are
readily convertible to known amounts of cash and are so near
their maturity that they present an insignificant risk of change
in value because of interest rate changes are included within
cash and cash equivalents in the above cash flow information.
E. Discontinued
operations (see also note B)
On 28 October 2003, the Group disposed of its entire
interests in its Swedish drug delivery and development business,
comprising Gacell Holdings AB and Amarin Development (Sweden)
AB. On 25 February 2004, the Group disposed of its entire
interests in Amarin Pharmaceuticals Inc. In accordance with, UK
GAAP (FRS 3 Reporting Financial Performance) the
Group has classified both these transactions as discontinued and
has restated the comparatives on this basis.
F. Stock-based
compensation and National Insurance
Under UK GAAP the Company has recorded a provision for $15,000
(31 December 2004: $32,000, 31 December 2003: $nil)
relating to National Insurance (NI) amounts payable
on stock option gains at the time of exercise. Under UK
GAAP NI contributions are accrued over the vesting period
of the underlying option. Under US GAAP payroll taxes on stock
options are accrued when the liability is incurred.
The Company has re-priced certain stock options issued to
directors and employees. Under US GAAP these have been accounted
for using variable plan accounting as directed by FIN 44,
for 2005, 2004 and 2003 the impact was $nil, as the fair value
was below the exercise price of the re-priced options.
In 2005, the Company accelerated the vesting of 412,600 options
held by terminated employees. In 2004 the Company accelerated
the vesting of 1,228,760 options held by terminated employees.
In 2003, no options were accelerated. This modification has been
considered a re-pricing and will be accounted for using variable
accounting.
F-66
The Company applies APB Opinion No. 25 and related
interpretations in accounting for its US share option plans. Had
compensation for the Companys share option plans been
determined based on the fair value at the grant dates for awards
under those plans consistent with the method of
SFAS No. 123, the Companys net (loss) and net
(loss) per share under US GAAP would have been the pro forma
amounts indicated below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended
|
|
|
Year ended
|
|
|
Year ended
|
|
|
|
31 December
|
|
|
31 December
|
|
|
31 December
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Net (loss) as reported
|
|
|
(19,630
|
)
|
|
|
(67,202
|
)
|
|
|
(28,436
|
)
|
Deduct: Stock-based employee
compensation expense determined under fair value based method
for all awards, net of related tax effect
|
|
|
(2,337
|
)
|
|
|
(4,739
|
)
|
|
|
(6,580
|
)*
|
Add back total stock based
compensation expense determined under the intrinsic value based
method
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma net (loss)
|
|
|
(21,967
|
)
|
|
|
(71,941
|
)
|
|
|
(35,016
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
Included in 2003 is $748,000 in respect of a charge recognized
in relation to 2002 and 2001. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
Basic and diluted (loss) per
ordinary share as reported
|
|
|
(0.42
|
)
|
|
|
(2.99
|
)
|
|
|
(1.66
|
)
|
Proforma
|
|
|
(0.47
|
)
|
|
|
(3.20
|
)
|
|
|
(2.05
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
Weighted average grant date fair
value
|
|
|
|
|
|
|
|
|
|
|
|
|
Options granted at the market price
|
|
|
1.07
|
|
|
|
0.77
|
|
|
|
2.06
|
|
Options granted at a premium to
the market price
|
|
|
|
|
|
|
|
|
|
|
1.55
|
|
Options granted at a discount to
the market price
|
|
|
|
|
|
|
|
|
|
|
|
|
The fair value for options granted was estimated on the date of
grant using the Black-Scholes option-pricing model with the
following weighted-average assumptions and no dividends.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended
|
|
|
Year ended
|
|
|
Year ended
|
|
|
|
31 December
|
|
|
31 December
|
|
|
31 December
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
Options granted at the market price
|
|
|
|
|
|
|
|
|
|
|
|
|
Risk free interest rate
(percentage)
|
|
|
3.95
|
|
|
|
3.26
|
|
|
|
2.51
|
|
Expected life (in years)
|
|
|
4.00
|
|
|
|
4.00
|
|
|
|
4.00
|
|
Volatility (percentage)
|
|
|
106
|
|
|
|
108
|
|
|
|
107
|
|
Options granted at a premium to
the market price
|
|
|
|
|
|
|
|
|
|
|
|
|
Risk free interest rate
(percentage)
|
|
|
|
|
|
|
|
|
|
|
3.10
|
|
Expected life (in years)
|
|
|
|
|
|
|
|
|
|
|
4.00
|
|
Volatility (percentage)
|
|
|
|
|
|
|
|
|
|
|
108
|
|
Options granted at a discount to
the market price
|
|
|
|
|
|
|
|
|
|
|
|
|
Risk free interest rate
(percentage)
|
|
|
|
|
|
|
|
|
|
|
|
|
Expected life (in years)
|
|
|
|
|
|
|
|
|
|
|
|
|
Volatility (percentage)
|
|
|
|
|
|
|
|
|
|
|
|
|
F-67
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
2005
|
|
|
2004
|
|
|
2004
|
|
|
2003
|
|
|
2003
|
|
|
|
Number of
|
|
|
Weighted average
|
|
|
Number of
|
|
|
Weighted average
|
|
|
Number of
|
|
|
Weighted average
|
|
|
|
options
|
|
|
exercise price
|
|
|
options
|
|
|
exercise price
|
|
|
options
|
|
|
exercise price
|
|
|
|
|
|
|
$
|
|
|
|
|
|
$
|
|
|
|
|
|
$
|
|
|
Options granted at market
price
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at 1 January
|
|
|
1,629,824
|
|
|
|
1.84
|
|
|
|
292,633
|
|
|
|
5.50
|
|
|
|
137,275
|
|
|
|
8.67
|
|
Granted
|
|
|
1,975,000
|
|
|
|
1.74
|
|
|
|
1,338,891
|
|
|
|
1.04
|
|
|
|
160,933
|
|
|
|
3.08
|
|
Exercised
|
|
|
(10,000
|
)
|
|
|
0.84
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lapsed
|
|
|
(36,666
|
)
|
|
|
2.04
|
|
|
|
(1,700
|
)
|
|
|
5.75
|
|
|
|
(5,575
|
)
|
|
|
13.89
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at 31 December
|
|
|
3,558,158
|
|
|
|
1.78
|
|
|
|
1,629,824
|
|
|
|
1.84
|
|
|
|
292,633
|
|
|
|
5.50
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at 31 December
|
|
|
1,143,958
|
|
|
|
2.27
|
|
|
|
278,099
|
|
|
|
3.83
|
|
|
|
78,100
|
|
|
|
5.15
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options granted at a discount to
the market price
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at 1 January
|
|
|
1,652,093
|
|
|
|
4.94
|
|
|
|
2,046,155
|
|
|
|
4.63
|
|
|
|
2,259,359
|
|
|
|
4.36
|
|
Granted
|
|
|
10,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
290,000
|
|
|
|
2.68
|
|
Exercised
|
|
|
(10,000
|
)
|
|
|
2.38
|
|
|
|
|
|
|
|
|
|
|
|
(7,900
|
)
|
|
|
0.15
|
|
Lapsed
|
|
|
(870,966
|
)
|
|
|
4.36
|
|
|
|
(394,062
|
)
|
|
|
3.30
|
|
|
|
(495,304
|
)
|
|
|
2.36
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at 31 December
|
|
|
781,127
|
|
|
|
5.59
|
|
|
|
1,652,093
|
|
|
|
4.94
|
|
|
|
2,046,155
|
|
|
|
4.63
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at 31 December
|
|
|
736,682
|
|
|
|
5.75
|
|
|
|
1,287,579
|
|
|
|
4.23
|
|
|
|
1,350,060
|
|
|
|
2.73
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options granted at a premium to
market price
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at 1 January
|
|
|
892,007
|
|
|
|
5.98
|
|
|
|
943,731
|
|
|
|
5.93
|
|
|
|
945,912
|
|
|
|
5.93
|
|
Granted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
53,000
|
|
|
|
3.16
|
|
Exercised
|
|
|
(119,577
|
)
|
|
|
3.05
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lapsed
|
|
|
(289,763
|
)
|
|
|
10.12
|
|
|
|
(51,724
|
)
|
|
|
5.10
|
|
|
|
(55,181
|
)
|
|
|
3.26
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at 31 December
|
|
|
482,667
|
|
|
|
4.22
|
|
|
|
892,007
|
|
|
|
5.98
|
|
|
|
943,731
|
|
|
|
5.93
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at 31 December
|
|
|
479,334
|
|
|
|
4.22
|
|
|
|
627,475
|
|
|
|
5.92
|
|
|
|
440,226
|
|
|
|
5.14
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-68
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding
|
|
|
Options exercisable
|
|
|
|
|
|
|
Number
|
|
|
|
|
|
Number
|
|
|
|
|
|
|
outstanding at
|
|
|
Remaining
|
|
|
outstanding
|
|
|
|
Exercise
|
|
|
31 December
|
|
|
contractual
|
|
|
at 31 December
|
|
|
|
price($)
|
|
|
2005
|
|
|
life (days)
|
|
|
2005
|
|
|
Options granted at market
price
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0.72
|
|
|
|
5,000
|
|
|
|
1,430
|
|
|
|
5,000
|
|
|
|
|
0.84
|
|
|
|
357,500
|
|
|
|
10,461
|
|
|
|
135,833
|
|
|
|
|
0.85
|
|
|
|
375,000
|
|
|
|
3,474
|
|
|
|
125,000
|
|
|
|
|
0.87
|
|
|
|
45,000
|
|
|
|
2,345
|
|
|
|
45,000
|
|
|
|
|
1.09
|
|
|
|
200,000
|
|
|
|
3,280
|
|
|
|
200,000
|
|
|
|
|
1.09
|
|
|
|
160,000
|
|
|
|
7,662
|
|
|
|
|
|
|
|
|
1.15
|
|
|
|
40,000
|
|
|
|
1,551
|
|
|
|
40,000
|
|
|
|
|
1.16
|
|
|
|
325,000
|
|
|
|
3,988
|
|
|
|
|
|
|
|
|
1.18
|
|
|
|
10,000
|
|
|
|
3,998
|
|
|
|
|
|
|
|
|
1.25
|
|
|
|
554,725
|
|
|
|
10,701
|
|
|
|
299,169
|
|
|
|
|
1.30
|
|
|
|
500,000
|
|
|
|
7,626
|
|
|
|
|
|
|
|
|
1.33
|
|
|
|
80,000
|
|
|
|
2,604
|
|
|
|
80,000
|
|
|
|
|
1.37
|
|
|
|
20,000
|
|
|
|
3,846
|
|
|
|
|
|
|
|
|
1.38
|
|
|
|
10,000
|
|
|
|
2,127
|
|
|
|
10,000
|
|
|
|
|
1.42
|
|
|
|
10,000
|
|
|
|
3,904
|
|
|
|
|
|
|
|
|
1.44
|
|
|
|
20,000
|
|
|
|
3,896
|
|
|
|
|
|
|
|
|
1.49
|
|
|
|
20,000
|
|
|
|
3,915
|
|
|
|
|
|
|
|
|
1.50
|
|
|
|
100,000
|
|
|
|
3,922
|
|
|
|
|
|
|
|
|
2.40
|
|
|
|
20,000
|
|
|
|
3,619
|
|
|
|
6,667
|
|
|
|
|
2.43
|
|
|
|
10,000
|
|
|
|
3,739
|
|
|
|
|
|
|
|
|
2.82
|
|
|
|
40,000
|
|
|
|
3,040
|
|
|
|
26,667
|
|
|
|
|
3.04
|
|
|
|
550,000
|
|
|
|
11,133
|
|
|
|
100,000
|
|
|
|
|
3.17
|
|
|
|
105,933
|
|
|
|
2,976
|
|
|
|
70,622
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,558,158
|
|
|
|
|
|
|
|
1,143,958
|
|
Options granted at a discount to
the market price
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0.30
|
|
|
|
51,293
|
|
|
|
5,720
|
|
|
|
51,293
|
|
|
|
|
0.30
|
|
|
|
10,000
|
|
|
|
1,922
|
|
|
|
10,000
|
|
|
|
|
0.33
|
|
|
|
15,000
|
|
|
|
2,785
|
|
|
|
15,000
|
|
|
|
|
0.50
|
|
|
|
250,000
|
|
|
|
1,423
|
|
|
|
250,000
|
|
|
|
|
1.00
|
|
|
|
15,000
|
|
|
|
2,373
|
|
|
|
15,000
|
|
|
|
|
1.60
|
|
|
|
35,000
|
|
|
|
2,536
|
|
|
|
35,000
|
|
|
|
|
1.77
|
|
|
|
201,500
|
|
|
|
1,430
|
|
|
|
201,500
|
|
|
|
|
2.38
|
|
|
|
70,000
|
|
|
|
3,247
|
|
|
|
70,000
|
|
|
|
|
2.82
|
|
|
|
133,334
|
|
|
|
2,981
|
|
|
|
88,889
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
781,127
|
|
|
|
|
|
|
|
736,682
|
|
Options granted at a premium to
market price
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0.31
|
|
|
|
236,667
|
|
|
|
2,866
|
|
|
|
236,667
|
|
|
|
|
0.35
|
|
|
|
60,000
|
|
|
|
2,756
|
|
|
|
60,000
|
|
|
|
|
0.61
|
|
|
|
20,000
|
|
|
|
2,240
|
|
|
|
20,000
|
|
|
|
|
0.88
|
|
|
|
5,000
|
|
|
|
2,692
|
|
|
|
5,000
|
|
|
|
|
1.29
|
|
|
|
6,000
|
|
|
|
2,398
|
|
|
|
6,000
|
|
|
|
|
1.97
|
|
|
|
20,000
|
|
|
|
2,597
|
|
|
|
20,000
|
|
|
|
|
2.13
|
|
|
|
15,000
|
|
|
|
2,464
|
|
|
|
15,000
|
|
|
|
|
2.50
|
|
|
|
100,000
|
|
|
|
1,423
|
|
|
|
100,000
|
|
|
|
|
3.37
|
|
|
|
20,000
|
|
|
|
3,125
|
|
|
|
16,667
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
482,667
|
|
|
|
|
|
|
|
479,334
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total at 31 December
2005
|
|
|
|
|
|
|
4,821,952
|
|
|
|
|
|
|
|
2,359,974
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
G. IFRS
IFRS is applicable to certain corporations, including public
companies with shares listed on European Union stock exchanges.
Amarin shares are listed on the NASDAQ (Capital Markets)
exchange and as such fall outside the requirement to report
under IFRS. Management will continue to evaluate whether to
adopt IFRS rather than UK GAAP for the companys UK
reporting.
F-69
H. Recently
issued accounting standards
In December 2004 the FASB issued Financial Accounting Standard
No. 123R, Share-Based Payment (FAS 123R).
FAS 123R requires that companies expense the value of
employee stock options and other awards. FAS 123R allows
companies to chose an option pricing model that appropriately
reflects their specific circumstances and the economics of their
transactions, and allows companies to select from three
transition methods for adoption of the provisions of the
standard. FAS 123R is effective for Amarin from the fiscal
period beginning January 1, 2006 and Amarin will adopt
FAS 123R effective from the beginning of this period.
FAS 123R requires that the Company account for previous
share options and future grants under the guidance of
FAS 123, which requires fair-value accounting. Upon
adoption of this standard management expects that the additional
expense recorded will be approximate to the fair value amounts
reported in the pro forma disclosure.
In December 2004 the FASB issued Financial Accounting Standard
No. 153, Exchanges of Nonmonetary Assets (FAS 153).
FAS 153 amends APB Opinion No. 29, Accounting for
Nonmonetary Transactions, to eliminate the exception for
nonmonetary exchanges of similar productive assets and replaces
it with a general exception for exchanges of nonmonetary assets
that do not have commercial substance. A nonmonetary exchange
has commercial substance if the future cash flows of the entity
are expected to change significantly as a result of the
exchange. FAS 153 is effective for Amarin for nonmonetary
exchanges occurring after January 1, 2006. Management does
not expect the adoption of this standard to have a material
impact on the financial statements.
I. Earnings
per share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended
|
|
|
Year ended
|
|
|
Year ended
|
|
|
|
31 December
|
|
|
31 December
|
|
|
31 December
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
US GAAP net (loss) available to
common stockholders
|
|
|
(19,630
|
)
|
|
|
(67,202
|
)
|
|
|
(28,436
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number
|
|
|
Number
|
|
|
Number
|
|
|
|
000
|
|
|
000
|
|
|
000
|
|
|
Basic weighted-average shares
|
|
|
46,590
|
|
|
|
22,511
|
|
|
|
17,093
|
|
Plus: Incremental shares from
assumed conversions
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
|
|
|
|
|
|
|
|
|
|
|
4
|
|
Warrants
|
|
|
|
|
|
|
|
|
|
|
343
|
|
Convertible preferred stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted weighted-average shares
|
|
|
46,590
|
|
|
|
22,511
|
|
|
|
17,440
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended
|
|
|
Year ended
|
|
|
Year ended
|
|
|
|
31 December
|
|
|
31 December
|
|
|
31 December
|
|
|
|
2005
|
|
|
2004
|
|
|
2003
|
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
Basic (loss) per share
|
|
|
(0.42
|
)
|
|
|
(2.99
|
)
|
|
|
(1.66
|
)
|
Diluted earnings per share
|
|
|
*
|
|
|
|
*
|
|
|
|
*
|
|
|
|
|
* |
|
The dilutive effect of the Companys options, warrants and
convertible preferred stock have been excluded as the impact
would have been antidilutive for the periods indicated above.
Please refer to Notes (30) and (31) for more
information with regard to these securities. 139,577 and
7,900 shares were issued in 2005 and 2003 respectively,
upon the exercise of certain options. No options were exercised
in 2004. For 2004, loan notes of $2 million, which were
redeemable for equity at the option of the holder, were excluded
from the above dilution calculation as any conversion would
arise during a future financing at which a price and therefore
associated quantity of shares would be determined. |
J. Treatment
of intangible fixed assets
Under UK GAAP pharmaceutical products that are acquired which
are in the clinical trials phase of development can be
capitalized and amortized where there is a sufficient likelihood
of future economic benefit.
F-70
Under US GAAP specific guidance relating to pharmaceutical
products in the development phase requires such amounts to be
expensed as in-process research and development unless they have
attained certain regulatory milestones.
Under UK GAAP the Group has capitalized $9,627,000 at
December 31, 2005 (December 31, 2004: $10,302,000,
31 December, 2003: $4,149,000), relating mainly to Miraxion
(formerly known as LAX-101).
Under US GAAP an in-process research and development charge of
$48,235,000 arises in 2004 representing the write off of the
Miraxion intangible asset that arises on the acquisition of
Laxdale. The reconciling adjustment for the treatment of
intangible fixed assets represents this in process research and
development charge of $48,235,000, less the associated
amortization charged under UK GAAP of $599,000 and the disposal
of Zelapar option rights held prior to the Valeant transaction
of $106,000. Note 43 includes an explanation of the
difference between UK and US GAAP on the acquisition accounting
for Laxdale at October 8, 2004. The 2005 and 2003 income
statements represent the amortization charged under UK GAAP of
$675,000 and $576,000 respectively, with respect to Miraxion
which had been expensed when incurred under US GAAP.
K. Adjustment
for revenue recognition
During 2005, the Company received an initial access fee of
$500,000 on the licensing of technology. Under UK GAAP, this
license fee was recognized as income in 2005. Under US GAAP,
this income is deferred and will be recognized over the life of
the contract.
Under UK GAAP milestone payments have been recognized when
achieved. Under US GAAP, the Companys adoption of
SAB 101 (which has now been updated by
SAB 104) resulted in a $617,000 cumulative adjustment
in respect of its accounting for certain up-front payments and
refundable milestone payments. The deferral and release
increased sales by $nil for the year ended 31 December
2003. During 2004, management has released the remaining
deferred revenue as the associated business was sold in 1999 and
there is little expectation of any claims against this revenue.
This release of deferred income increased sales by $617,000 for
the year ended 31 December 2004 under US GAAP.
L. Gain
on settlement/renegotiation of related party liability
Under UK GAAP the Group recognized a gain in 2003 and 2004 on
the renegotiation of a liability due to Elan, related party.
Under US GAAP the extinguishment of a related party liability is
considered a contribution to capital.
M. Imputed
interest on non-interest bearing debt
In connection with the Groups acquisition of the product
portfolio from Elan in September 1999, the Group obtained a
non-interest bearing loan for a period of one year in the amount
of $6,500,000 to fund the acquisition of such portfolio. Under
UK GAAP the face value of the note is the fair value of the
portfolio acquired. Under US GAAP the note payable is recorded
at the present value of amounts to be paid determined using an
appropriate interest rate. The note payable is then accreted up
to its face value over the term of the loan with a corresponding
charge to interest expense.
During 2003, following renegotiation, all liabilities due to
Elan became payable by 31 March 2004. As the maturity of
these liabilities was three months from the balance sheet date,
the Group considered there to be no difference between the
carrying value and the fair value. These liabilities were
settled in February 2004.
N. Preference
dividends
Under UK GAAP cumulative preferred dividends are accrued whether
paid or not. Under US GAAP, preferred dividends are not
accounted for until declared. The Companys issued
preference shares have now been converted into ordinary shares,
so no GAAP difference remains.
F-71
O. Revenue
Recognition
Under UK GAAP the Company recognized revenue on dispatch of
goods. Under US GAAP revenue is recognized on delivery to the
customer, when title is deemed to pass. Normally, there is an
insignificant timing difference between dispatch and delivery to
the customer and hence no adjustment is recorded. However,
during the last week of December 2002, such a delay occurred and
accordingly an adjustment of $348,000 was made in 2002 to
reflect the profit element of sales ($736,000) recognized under
UK GAAP but deferred under US GAAP. The associated adjustment to
cost of sales would be $388,000. During 2003, and 2004, there
were no such cut-off differences.
P. Adjustment
to Permax purchase consideration
Under UK GAAP purchase consideration paid by means of a note
payable is measured at its principal amount. Under US GAAP
purchase consideration is measured by reference to the fair
value of the liability assumed. At the date in 2002 the Group
exercised its Permax option, the fair value of its obligation to
Elan was $3,073,000 lower than the face amount of the liability
as determined by discounting future cash flows at US dollar
LIBOR plus 4% being 5.66%.
As of December 31, 2002, the basis difference was
eliminated as a result of the impairment recognized with respect
to Permax. However, as a result of the initial basis difference,
the impairment under US GAAP was $3,073,000 lower that that
recognized under UK GAAP, partly offset by an additional
$927,000 in interest recognized using the effective interest
method.
During 2003, following renegotiation, all liabilities due to
Elan became payable by 31 March 2004. As the maturity of
these liabilities was three months from the balance sheet date,
the Group considered there to be no remaining difference between
the carrying value and the fair value. These liabilities were
settled in February 2004.
Q. Fair
value of warrants
On 21 December 2005, the Company issued 9,135,034 warrants
solely as an inducement to participate in the December 2005
equity fundraising by private placement. No services, past or
present, were received in order to earn the warrants. Under US
GAAP, the fair value of these warrants, using the Black-Scholes
pricing model, has been calculated as $9,957,187 and is included
in the share premium account within additional paid in capital.
The net impact on the US GAAP shareholders equity is
therefore $nil. Under UK GAAP no such charge is currently
required.
The Group issued 313,234 warrants on 27 January 2003. Under
US GAAP, in 2004, the value of these warrants using the
Black-Scholes pricing model is $170,000 (2003: $158,000).
Because these warrants were issued in connection with a
fundraising, this would be charged against the share premium
account and offset by a matching entry to the profit and loss
reserve. The net impact on the US GAAP shareholders equity
is therefore $nil. Under UK GAAP no such charge is currently
required.
R. Discount
on loan note
As disclosed in note 25, in February 2004 Amarin issued a
$5 million loan note and 500,000 warrants to Elan, as part
of the settlement of debt obligations. In October 2004,
Mr. Thomas Lynch purchased all of Elans interests in
Amarin, which included the $5 million loan note and 500,000
warrants. Subsequently, Amarin agreed with Mr. Lynch to the
redemption of $3,000,000 of the loan note for ordinary share
capital at a ten-day trailing average market price; the result
being that, at the end of 2004, Amarin had in issue
$2 million loan notes and 500,000 warrants in favor of
Mr. Lynch. AIHL redeemed the remaining $2 million of
the loan note and to subscribe for 1,538,461 ordinary shares as
part of the registered direct offering completed in May 2005.
Under US GAAP the $2 million loan note and the 500,000
warrants issued to Mr. Lynch in 2004 have been accounted
for under APB 14, so that the proceeds of the loan note
have been allocated between the debt and the warrants based on
their relative fair values. The debt is being accreted up to its
face value over the term of the loan note, with a corresponding
charge to interest expense. The fair value of the warrants is
being retained in additional paid in capital until such times as
they are exercised, lapse, or are otherwise dealt with. The
initial value of the
F-72
discount representing the fair value of the warrants was
$389,000. The amortization of this balance of the period to
31 December 2004 was $20,000 leaving a year end carrying
value of $369,000. This was written off in period to
31 December 2005. Under UK GAAP the warrants are regarded
as not having affected the finance cost of the loan note.
S. Vacation
accrual
Under UK GAAP, Amarin does not provide for vacation expense. To
comply with US GAAP this expense would be fully provided for. At
31 December 2005, the value was $78,000 (31 December
2004; $35,000).
T. Adjustment
for acquisition accounting
As detailed in note 43B and C, under US GAAP, the inclusion
of the intangible fixed asset at fair value in the acquisition
accounting gives rise to negative goodwill.
Under US GAAP, when a business combination involves contingent
consideration that, when resolved, might result in the
recognition of an additional element of cost with respect to the
acquired entity, a deferred credit should be recognized for the
lesser of (1) the maximum amount of contingent
consideration or (2) the initial amount of negative
goodwill. The maximum amount of the contingent consideration for
Laxdale is £25,000,000 ($48,200,000) as set out in
note 3 above. The initial amount of negative goodwill is
$41,354,000 as set out below. Thus, a deferred credit of
$41,354,000 is recognized on the acquisition of Laxdale being
the initial amount of negative goodwill.
When the amount of any contingent consideration becomes known
and the consideration is issued or becomes issuable, any
difference between the fair value of the contingent
consideration issued or issuable and the deferred credit would
be treated as follows:
|
|
|
|
|
An excess of the fair value of the contingent consideration
issued or issuable over the amount of the deferred credit would
be recognized as additional cost of the acquired entity.
|
|
|
|
An excess of the deferred credit over the fair value of the
consideration issued or issuable would first be recognized as a
pro rata reduction of the amounts that were initially assigned
to eligible acquired assets, after which any remaining
difference would be recognized as an extraordinary gain.
|
U. Adjustment
for consolidation
Under UK GAAP, foreign currency subsidiaries are consolidated
into Group financial statements using the translation method
most appropriate for their circumstances. The Companys
accounting policies define the two methods available under UK
GAAP, see note 2.
Amarin Neuroscience Limited and Amarin Pharmaceuticals Ireland
Limited are interlinked and dependent on the Group for funding
and decision making. Both subsidiaries therefore meet the
criteria to use the temporal method and accordingly losses
arising on translation for consolidation are reported within the
income statement.
Under UK GAAP, foreign currency subsidiaries that are
independent and more autonomous are translated and consolidated
using the closing rate method, whereby gains or losses arising
on translation for consolidation are reported in reserves as
part of shareholders equity.
Under US GAAP, all gains and losses arising on translation for
consolidation are reported as part of shareholders equity,
within other comprehensive income, similar to the UK GAAP
closing rate method.
In 2005, using the temporal method for the translation and
consolidation of Amarin Neuroscience Limited and Amarin
Pharmaceutical Ireland Limited, an accounting translation credit
of $939,000 (2004 expense of $302,000) was recorded, under UK
GAAP, as part of the result for the year in the income
statement. This has been adjusted for in the US GAAP net income
reconciliation.
Using the closing rate method applicable under US GAAP would
have resulted in a reduction of $7,000 (2004: $17,000) to
shareholders equity as the temporal method also requires
non-monetary assets to be translated at the
F-73
exchange rate ruling at the date they were acquired rather than
the year-end rate. Under US GAAP, an amount of $949,000 (2004:
$319,000) would be dealt with through other comprehensive income.
Prior to 2004, under UK GAAP, subsidiaries were translated for
consolidation purposes using the method applicable for their
circumstances. For API and ADAB, this method was the closing
rate method as both subsidiaries were capable of functioning
independently of the Group, having generated their own cashflows
and raised finance locally, as required. No differences
therefore arose prior to 2004 with regard to the translation
method for consolidation.
V. Restructuring
provision staff redundancy costs
Under UK GAAP, redundancy obligations other than pensions are
liabilities, which should be recognized in the accounts in line
with FRS 12. In 2005, $441,000 was recognized in respect of
redundancy benefits.
Under US GAAP, redundancy benefits will only be accounted for
where they meet certain conditions. Where all such conditions
are not met in full, the amount is deferred. A portion of the
redundancy costs related to a statutory element ($24,000), so
these were accounted for under FAS 112. The statutory costs
met the criteria under FAS 112, therefore, these costs were
recorded in 2005. The remaining redundancy costs are accounted
for under FAS 146. Not all of these remaining costs met all
the criteria for recognition in 2005, thus $80,000 of
redundancy costs will not be recognized until 2006.
W. Property
costs
Under UK GAAP, in 2005 Amarin recognized a liability of $187,000
being the property costs associated with the occupied portion of
the Stirling property for the period April to December 2006. (It
is Amarins intention to vacate the property at
March 31st and notice has been given to the effect).
Under US GAAP, no liability should be recognized until the
property has been vacated.
43. Acquisition
accounting
The following summarizes the differences between UK and US GAAP
for acquisition accounting.
This note should be read in conjunction with note 3, which
details the acquisition of Amarin Neuroscience Limited (formerly
Laxdale Limited), which was concluded on 8 October 2004.
A. Fair
value table under UK GAAP
This table reflects the purchase of the intangible asset,
tangible fixed assets and working capital items of Laxdale as
financed by shares issued at a premium. The following analyses
the fair value accounting under UK GAAP (FRS 6, FRS 7,
FRS 10).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
UK GAAP
|
|
|
|
|
|
|
Fair value
|
|
|
acquisition
|
|
|
|
Laxdale
|
|
|
adjustment
|
|
|
accounting
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Intangible fixed assets
|
|
|
|
|
|
|
6,858
|
|
|
|
6,858
|
|
Tangible fixed assets
|
|
|
218
|
|
|
|
|
|
|
|
218
|
|
Investments
|
|
|
282
|
|
|
|
(65
|
)
|
|
|
217
|
|
Net current liabilities
|
|
|
(2,700
|
)
|
|
|
|
|
|
|
(2,700
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net liabilities acquired
|
|
|
(2,200
|
)
|
|
|
6,793
|
|
|
|
4,593
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consideration
|
|
No. of Shares
(000)
|
|
|
$
|
|
|
|
|
|
shares issued at fair value
(market value)
|
|
|
3,500
|
|
|
|
1.08
|
|
|
|
3,780
|
|
Other costs of acquisition
|
|
|
|
|
|
|
|
|
|
|
813
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-74
Fair value adjustments were considered for all
assets/liabilities present on Laxdales balance sheet at
the date of acquisition (8 October 2004). For all asset
classes other than intangible fixed assets and investments, no
fair value adjustment were proposed due to materiality and
specifically, the ongoing use of certain items such as tangible
fixed assets and the proximity to settlement for the other
current assets and liabilities. Other acquisition additional
liabilities were considered but none were noted as they do not
meet the FRS 7 definitions in that there were no demonstrable
commitments that would exist irrespective of the acquisition
being consummated or not.
The most significant fair value adjustment is the recognition of
an intangible asset, representing intellectual property rights.
Per FRS 7, (para 1 and 2), the recognition criteria for
intangible assets of separability (can be disposed of separately
from the company as a whole) and control (either via custody or
legal/contractual rights) are met, as is the FRS 5 definition of
an asset, being the right to future economic benefits. Per
FRS 10, reliable measurement of the intangible is achieved
by discounted cashflow analysis resulting in a valuation which
is then capped by FRS 10 para 10 such that negative goodwill
does not arise. This gave rise to the recognition of an
intangible asset, representing intellectual property rights of
$6,858,000 which is being amortized over 15.5 years
representing the time to patent expiry.
Laxdale has a shareholding in Amarin (see note 32). The
fair value adjustment to investments, of $65,000, writes down
the value of these shares from that held within Laxdales
financial statements to the market value at 8 October 2004.
This value was $1.08 per share.
B. Fair
value table under US GAAP and comparison to UK GAAP
This table shows the negative goodwill arising on the
acquisition due to the fair value of the separable net assets
exceeding the fair value of the consideration. The additional
value assigned under US GAAP to the intangible asset is shown
(representing the difference between the value assigned under UK
GAAP and US GAAP) together with the impact of Laxdales US
GAAP revenue recognition difference under SAB 104 leading
to the deferral of revenue. Below is the US GAAP fair value
accounting in accordance with
FAS 141 Business Combinations.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
US GAAP
|
|
|
UK GAAP
|
|
|
Difference
|
|
|
|
|
|
|
Fair value
|
|
|
acquisition
|
|
|
acquisition
|
|
|
between US
|
|
|
|
Laxdale
|
|
|
adjustment
|
|
|
accounting
|
|
|
accounting
|
|
|
and UK GAAP
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Intangible fixed assets
|
|
|
|
|
|
|
48,235
|
|
|
|
48,235
|
|
|
|
6,858
|
|
|
|
41,377
|
|
Tangible fixed assets
|
|
|
218
|
|
|
|
|
|
|
|
218
|
|
|
|
218
|
|
|
|
|
|
Investments
|
|
|
282
|
|
|
|
(65
|
)
|
|
|
217
|
|
|
|
217
|
|
|
|
|
|
Net current liabilities
|
|
|
(2,700
|
)
|
|
|
|
|
|
|
(2,700
|
)
|
|
|
(2,700
|
)
|
|
|
|
|
US GAAP
differences see below
|
|
|
(9,448
|
)
|
|
|
9,425
|
|
|
|
(23
|
)
|
|
|
|
|
|
|
(23
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net liabilities acquired
|
|
|
(11,648
|
)
|
|
|
57,595
|
|
|
|
45,947
|
|
|
|
4,593
|
|
|
|
41,354
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
No of Shares
|
|
|
|
|
|
|
|
|
|
|
|
|
(000)
|
|
|
$
|
|
|
|
|
|
|
|
|
shares issued at fair value
(market value)
|
|
|
3,500
|
|
|
|
1.08
|
|
|
|
3,780
|
|
|
|
3,780
|
|
Other costs of acquisition
|
|
|
|
|
|
|
|
|
|
|
813
|
|
|
|
813
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Negative goodwill
|
|
|
|
|
|
|
|
|
|
|
(41,354
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Laxdales US GAAP differences were in respect of the
following
Under UK GAAP, non-refundable licensing revenue in the form of
milestone payments is recognized upon transfer or licensing of
intellectual property rights. Where licensing agreements
stipulate payment on a milestone basis, revenue is recognized
upon achievement of those milestones. Revenues were stated net
of value added tax and similar taxes. No revenue was recognized
for consideration, the receipt of which was dependent on future
events, future performance or refund obligations.
Under US GAAP and in accordance with Staff Accounting
Bulletin 101 Revenue Recognition in Financial
Statements, as updated by Staff Accounting
Bulletin 104 Revenue Recognition and Emerging
Issues Task Force or EITF00-21 Revenue Arrangements with
Multiple Deliverables, revenue from licensing agreements
would be
F-75
recognized based upon the performance requirements of the
agreement. Non-refundable fees where the company has an ongoing
involvement or performance obligation, would be recorded as
deferred revenue in the balance sheet and amortized into license
fees in the profit and loss account over the estimated term of
the performance obligation.
Laxdale had received non-refundable milestone income under
license agreements with its licensing partners. Under the terms
of the license agreements it is the companys
responsibility to obtain approval of the licensed product and in
certain cases to supply the product to the licensee once the
product is approved. Under the terms of SABs 101 and 104 and
EITF00-21, these milestone fees were being deferred and
amortized in Laxdales books on a straight-line basis over
the estimated life of the relevant patent. This was considered
by the company to be the term of the performance obligations
under each license agreement.
As at 8 October 2004, Laxdale held a total of $9,425,000 of
deferred revenue on its balance sheet under US GAAP, analyzed as
$608,000 due to be released to income within one year and
$8,817,000 representing the fair value of the deferred revenue
for phased release after more than one year. However, the future
milestone fees associated with future performance obligations
under these license agreements were at market rates relative to
the future work being performed. Therefore, under EITF01-03, the
deferred revenue was written off as part of the purchase price
allocation and has been shown within the fair value adjustments
above.
Under UK GAAP Laxdale did not fully provide for vacation
expense. To comply with US GAAP this expense was fully provided
for. At 8 October the vacation provision was $23,000.
C. Negative
goodwill and recognition of deferred credit
Under US GAAP, when a business combination involves contingent
consideration that, when resolved, might result in the
recognition of an additional element of cost with respect to the
acquired entity, a deferred credit should be recognized for the
lesser of (1) the maximum amount of the contingent
consideration or (2) the initial amount of negative
goodwill. The maximum amount of the contingent consideration for
Laxdale was £25,000,000 ($48,200,000) as set out in
note 3. The initial amount of negative goodwill was
$41,354,000 as set out below. Thus, a deferred credit of
$41,354,000 was recognized on the acquisition of Laxdale being
the initial amount of negative goodwill.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
US GAAP
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
acquisition
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
accounting
|
|
|
|
|
|
|
|
|
|
|
|
|
Recognition of
|
|
|
after
|
|
|
|
|
|
|
|
|
|
US GAAP
|
|
|
negative
|
|
|
recognition of
|
|
|
|
|
|
|
Fair value
|
|
|
acquisition
|
|
|
goodwill as a
|
|
|
deferred
|
|
|
|
Laxdale
|
|
|
adjustment
|
|
|
accounting
|
|
|
deferred credit
|
|
|
credit
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Intangible fixed assets
|
|
|
|
|
|
|
48,235
|
|
|
|
48,235
|
|
|
|
|
|
|
|
48,235
|
|
Tangible fixed assets
|
|
|
218
|
|
|
|
|
|
|
|
218
|
|
|
|
|
|
|
|
218
|
|
Investments
|
|
|
282
|
|
|
|
(65
|
)
|
|
|
217
|
|
|
|
|
|
|
|
217
|
|
Net current liabilities
|
|
|
(2,700
|
)
|
|
|
|
|
|
|
(2,700
|
)
|
|
|
|
|
|
|
(2,700
|
)
|
Deferred credit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(41,354
|
)
|
|
|
(41,354
|
)
|
US GAAP differences
|
|
|
(9,448
|
)
|
|
|
9,425
|
|
|
|
(23
|
)
|
|
|
|
|
|
|
(23
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net liabilities acquired
|
|
|
(11,648
|
)
|
|
|
57,595
|
|
|
|
45,947
|
|
|
|
|
|
|
|
4,593
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
000
|
|
|
$
|
|
|
|
|
|
|
|
|
shares issued at fair value
(market value)
|
|
|
3,500
|
|
|
|
1.08
|
|
|
|
3,780
|
|
|
|
|
|
Other costs of acquisition
|
|
|
|
|
|
|
|
|
|
|
813
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Negative goodwill
|
|
|
|
|
|
|
|
|
|
|
(41,354
|
)
|
|
|
41,354
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-76
The following table shows the write-off to operating expenses
within the income statement, in accordance with US GAAP, of the
intangible asset that was created by the acquisition, as shown
in the above table, of $48,235,000.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
US GAAP
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
acquisition
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
accounting
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
after
|
|
|
Write-off of
|
|
|
US GAAP
|
|
|
UK GAAP
|
|
|
|
|
|
|
recognition of
|
|
|
intangible
|
|
|
effect of
|
|
|
effect of
|
|
|
Oct 8, 2004
|
|
|
|
deferred
|
|
|
fixed asset as
|
|
|
acquisition on
|
|
|
acquisition on
|
|
|
difference between
|
|
|
|
credit
|
|
|
in-process R&D
|
|
|
Amarin
|
|
|
Amarin
|
|
|
US and UK GAAP
|
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
$000
|
|
|
Intangible fixed assets
|
|
|
48,235
|
|
|
|
(48,235
|
)
|
|
|
|
|
|
|
6,858
|
|
|
|
(6,858
|
)
|
Tangible fixed assets
|
|
|
218
|
|
|
|
|
|
|
|
218
|
|
|
|
218
|
|
|
|
|
|
Investments
|
|
|
217
|
|
|
|
|
|
|
|
217
|
|
|
|
217
|
|
|
|
|
|
Net current liabilities
|
|
|
(2,700
|
)
|
|
|
|
|
|
|
(2,700
|
)
|
|
|
(2,700
|
)
|
|
|
|
|
Deferred credit
|
|
|
(41,354
|
)
|
|
|
|
|
|
|
(41,354
|
)
|
|
|
|
|
|
|
(41,354
|
)
|
US GAAP vacation
accrual
|
|
|
(23
|
)
|
|
|
|
|
|
|
(23
|
)
|
|
|
|
|
|
|
(23
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net liabilities acquired
|
|
|
4,593
|
|
|
|
(48,235
|
)
|
|
|
(43,642
|
)
|
|
|
4,593
|
|
|
|
(48,235
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma net revenues and loss from operations and net loss
under US GAAP calculated using Amarins audited financial
statements, would have been as follows if the acquisition had
occurred as of the beginning of the years ended
December 31, 2004 and 2003 respectively:
|
|
|
|
|
|
|
|
|
|
|
Year Ended
December 31,
|
|
|
|
2004
|
|
|
2003
|
|
|
|
(Unaudited)
|
|
|
|
$000
|
|
|
$000
|
|
|
Net revenues
|
|
|
2,095
|
|
|
|
8,157
|
|
Loss from operations
|
|
|
(70,000
|
)
|
|
|
(32,594
|
)
|
Net loss
|
|
|
(70,020
|
)
|
|
|
(35,189
|
)
|
Net loss per share
|
|
|
|
|
|
|
|
|
Basic
|
|
|
(3.11
|
)
|
|
|
(2.06
|
)
|
Diluted
|
|
|
(3.11
|
)
|
|
|
(2.06
|
)
|
Net loss per share is calculated using Amarins weighted
average number of shares as per note Note 42.
F-77
Exhibits
|
|
|
|
|
|
1
|
.1
|
|
Memorandum of Association of the
Company(16)
|
|
1
|
.2
|
|
Articles of Association of the
Company(16)
|
|
2
|
.1
|
|
Form of Deposit Agreement, dated
as of March 29, 1993, among the Company, Citibank, N.A., as
Depositary, and all holders from time to time of American
Depositary Receipts issued thereunder(1)
|
|
2
|
.2
|
|
Amendment No. 1 to Deposit
Agreement, dated as of October 8, 1998, among the Company,
Citibank, N.A., as Depositary, and all holders from time to time
of the American Depositary Receipts issued thereunder(2)
|
|
2
|
.3
|
|
Amendment No. 2 to Deposit
Agreement, dated as of September 25, 2002 among the
Company, Citibank N.A., as Depositary, and all holders from time
to time of the American Depositary Receipts issued thereunder(3)
|
|
2
|
.4
|
|
Form of Ordinary Share
certificate(10)
|
|
2
|
.5
|
|
Form of American Depositary
Receipt evidencing ADSs (included in Exhibit 2.3)(3)
|
|
2
|
.6
|
|
Registration Rights Agreement,
dated as of October 21, 1998, by and among Ethical Holdings
plc and Monksland Holdings B.V.(10)
|
|
2
|
.7
|
|
Amendment No. 1 to
Registration Rights Agreement and Waiver, dated January 27,
2003, by and among the Company, Elan International Services,
Ltd. and Monksland Holdings B.V.(10)
|
|
2
|
.8
|
|
Second Subscription Agreement,
dated as of November 1999, among Ethical Holdings PLC, Monksland
Holdings B.V. and Elan Corporation PLC(4)
|
|
2
|
.9
|
|
Purchase Agreement, dated as of
June 16, 2000, by and among the Company and the Purchasers
named therein(4)
|
|
2
|
.10
|
|
Registration Rights Agreement,
dated as of November 24, 2000, by and between the Company
and Laxdale Limited(5)
|
|
2
|
.11
|
|
Form of Subscription Agreement,
dated as of January 27, 2003 by and among the Company and
the Purchasers named therein(10) (The Company entered into
twenty separate Subscription Agreements on January 27, 2003
all substantially similar in form and content to this form of
Subscription Agreement.).
|
|
2
|
.12
|
|
Form of Registration Rights
Agreement, dated as of January 27, 2003 between the Company
and the Purchasers named therein(10) (The Company entered into
twenty separate Registration Rights Agreements on
January 27, 2003 all substantially similar in form and
content to this form of Registration Rights Agreement.)
|
|
2
|
.13
|
|
Securities Purchase Agreement
dated as of December 16, 2005 by and among the Company and
the purchasers named therein(17)
|
|
4
|
.1
|
|
Amended and Restated Asset
Purchase Agreement dated September 29, 1999 between Elan
Pharmaceuticals Inc. and the Company(10)
|
|
4
|
.2
|
|
Variation Agreement, undated,
between Elan Pharmaceuticals Inc. and the Company(10)
|
|
4
|
.3
|
|
License Agreement, dated
November 24, 2000, between the Company and Laxdale
Limited(6)
|
|
4
|
.4
|
|
Option Agreement, dated as of
June 18, 2001, between Elan Pharma International Limited
and the Company(7)
|
|
4
|
.5
|
|
Deed of Variation, dated
January 27, 2003, between Elan Pharma International Limited
and the Company(10)
|
|
4
|
.6
|
|
Lease, dated August 6, 2001,
between the Company and LB Strawberry LLC(7)
|
|
4
|
.7
|
|
Amended and Restated Distribution,
Marketing and Option Agreement, dated September 28, 2001,
between Elan Pharmaceuticals, Inc. and the Company(8)
|
|
4
|
.8
|
|
Amended and Restated License and
Supply Agreement, dated March 29, 2002, between Eli Lilly
and Company and the Company(10)
|
|
4
|
.9
|
|
Deed of Variation, dated
January 27, 2003, between Elan Pharmaceuticals Inc. and the
Company(10)
|
|
4
|
.10
|
|
Stock and Intellectual Property
Right Purchase Agreement, dated November 30, 2001, by and
among Abriway International S.A., Sergio Lucero, Francisco
Stefano, Amarin Technologies S.A., Amarin Pharmaceuticals
Company Limited and the Company(7)
|
|
4
|
.11
|
|
Stock Purchase Agreement, dated
November 30, 2001, by and among Abriway International S.A.,
Beta Pharmaceuticals Corporation and the Company(7)
|
|
|
|
|
|
|
4
|
.12
|
|
Novation Agreement, dated
November 30, 2001, by and among Beta Pharmaceuticals
Corporation, Amarin Technologies S.A. And the Company(7)
|
|
4
|
.13
|
|
Loan Agreement, dated
September 28, 2001, between Elan Pharma International
Limited and the Company(8)
|
|
4
|
.14
|
|
Deed of Variation, dated
July 19, 2002, amending certain provisions of the Loan
Agreement between the Company and Elan Pharma International
Limited(10)
|
|
4
|
.15
|
|
Deed of Variation No. 2,
dated December 23, 2002, between The Company and Elan
Pharma International Limited(10)
|
|
4
|
.16
|
|
Deed of Variation No. 3,
dated January 27, 2003, between the Company and Elan Pharma
International Limited(10)
|
|
4
|
.17
|
|
The Company 2002 Stock Option
Plan(9)
|
|
4
|
.18
|
|
Agreement Letter, dated
October 21, 2002, between the Company and Security Research
Associates, Inc.(10)
|
|
4
|
.19
|
|
Agreement, dated January 27,
2003, among the Company, Elan International Services, Ltd. and
Monksland Holdings B.V.(10)
|
|
4
|
.20
|
|
Master Agreement, dated
January 27, 2003, between Elan Corporation, plc., Elan
Pharma International Limited, Elan International Services, Ltd.,
Elan Pharmaceuticals, Inc., Monksland Holdings B.V. and the
Company(10)
|
|
4
|
.21
|
|
Form of Warrant Agreement, dated
March 19, 2003, between the Company and individuals
designated by Security Research Associates, Inc.(10) (The
Company entered into seven separate Warrant Agreements on
March 19, 2003 all substantially similar in form and
content to this form of Warrant Agreement).
|
|
4
|
.22
|
|
Sale and Purchase Agreement, dated
March 14, 2003, between F.
Hoffmann La Roche Ltd.,
Hoffmann La Roche Inc And the
Company(10)
|
|
4
|
.23
|
|
Share Subscription and Purchase
Agreement dated October 28, 2003 among the Company, Amarin
Pharmaceuticals Company Limited, Watson Pharmaceuticals, Inc.
and Lagrummet December NR 911 AB (under name change to WP
Holdings AB)(12)
|
|
4
|
.24
|
|
Asset Purchase Agreement dated
February 11, 2004 between the Company, Amarin
Pharmaceuticals Company Limited and Valeant Pharmaceuticals
International(12)
|
|
4
|
.25
|
|
Amendment No. 1 to Asset
Purchase Agreement dated February 25, 2004 between the
Company, Amarin Pharmaceuticals Company Limited and Valeant
Pharmaceuticals International(12)
|
|
4
|
.26
|
|
Development Agreement dated
February 25, 2004 between the Company and Valeant
Pharmaceuticals International(12)
|
|
4
|
.27
|
|
Settlement Agreement dated
February 25, 2004 among Elan Corporation plc, Elan Pharma
International Limited, Elan International Services, Ltd, Elan
Pharmaceuticals, Inc., Monksland Holdings BV and the Company(12)
|
|
4
|
.28
|
|
Debenture dated August 4,
2003 made by the Company in favour of Elan Corporation plc as
Trustee(12)
|
|
4
|
.29
|
|
Debenture Amendment Agreement
dated December 23, 2003 between the Company and Elan
Corporation plc as Trustee(12)
|
|
4
|
.30
|
|
Debenture Amendment Agreement
No. 2 dated February 24, 2004 between the Company and
Elan Corporation plc as Trustee(12)
|
|
4
|
.31
|
|
Loan Instrument dated
February 25, 2004 executed by Amarin in favor of Elan
Pharma International Limited(12)
|
|
4
|
.32
|
|
Amended and Restated Master
Agreement dated August 4, 2003 among Elan Corporation plc,
Elan Pharma International Limited, Elan International Services,
Ltd., Elan Pharmaceuticals, Inc., Monksland Holdings BV and the
Company(11)(12)
|
|
4
|
.33
|
|
Amended and Restated Option
Agreement dated August 4, 2003 between the Company and Elan
Pharma International Limited(11)(12)
|
|
4
|
.34
|
|
Deed of Variation No. 2,
dated August 4, 2003, to the Amended and Restated
Distribution, Marketing and Option Agreement between Elan
Pharmaceuticals, Inc. and the Company(11)(12)
|
|
4
|
.35
|
|
Deed of Variation No. 4,
dated August 4, 2003, to Loan Agreement between the Company
and Elan Pharma International Limited(11)(12)
|
|
4
|
.36
|
|
Amendment Agreement No. 1,
dated August 4, 2003, to Amended and Restated Asset
Purchase Agreement among Elan International Services, Ltd., Elan
Pharmaceuticals, Inc. and the Company(11)(12)
|
|
|
|
|
|
|
4
|
.37
|
|
Warrant dated February 25,
2004 issued by the Company in favor of the Warrant Holders named
therein(12)
|
|
4
|
.38
|
|
Amendment Agreement dated
December 23, 2003, between Elan Corporation plc, Elan
Pharma International Limited, Elan Pharmaceuticals, Inc.,
Monksland Holdings BV and the Company(11)(12)
|
|
4
|
.39
|
|
Bridging Loan Agreement dated
December 23, 2003 between the Company and Elan
Pharmaceuticals, Inc. (11)(12)
|
|
4
|
.40
|
|
Agreement dated December 23,
2003 between the Company and Elan Pharma International Limited,
amending the Amended and Restated Option Agreement dated
August 4, 2003(11)(12)
|
|
4
|
.41
|
|
Inventory Buy Back Agreement dated
March 18, 2004 between the Company and Swiftwater Group
LLC (12)
|
|
4
|
.42
|
|
Form of Subscription Agreement,
dated as of October 7, 2004 by and among the Company and
the Purchasers named therein(13) (The Company entered into 14
separate Subscription Agreements on October 7, 2004 all
substantially similar in form and content to this form of
Subscription Agreement.)
|
|
4
|
.43
|
|
Form of Registration Rights
Agreement, dated as of October 7, 2004 between the Company
and the Purchasers named therein(13) (The Company entered into
14 separate Registration Rights Agreements on October 7,
2004 all substantially similar in form and content to this form
of Registration Rights Agreement.)
|
|
4
|
.44
|
|
Share Purchase Agreement dated
October 8, 2004 between the Company, Vida Capital Partners
Limited and the Vendors named therein relating to the entire
issued share capital of Laxdale Limited(13)
|
|
4
|
.45
|
|
Escrow Agreement dated
October 8, 2004 among the Company, Belsay Limited and
Simcocks Trust Limited as escrow agent(13)
|
|
4
|
.46
|
|
Loan
Note Redemption Agreement dated October 14, 2004
between Amarin Investment Holding Limited and the Company(13)
|
|
4
|
.47
|
|
License and Distribution Agreement
dated March 26,2003 between Laxdale and SCIL Biomedicals
GMBH (14)
|
|
4
|
.48
|
|
License Agreement dated
July 21, 2003 between Laxdale and an undisclosed a third
party(14)
|
|
4
|
.49
|
|
Settlement agreement dated
27 September 2004 between the Company and Valeant
Pharmaceuticals International(14)
|
|
4
|
.50
|
|
Exclusive License Agreement dated
October 8, 2004 between Laxdale and Scarista Limited which
provides Laxdale with exclusive rights to specified intellectual
property of Scarista(14)
|
|
4
|
.51
|
|
Exclusive License Agreement dated
October 8, 2004 between Laxdale and Scarista Limited
pursuant to which Scarista has the exclusive right to use
certain of Laxdales intellectual property(14)
|
|
4
|
.52
|
|
Clinical Supply Agreement between
Laxdale and Nisshin Flour Milling Co., Limited dated
27th October 1999(14)
|
|
4
|
.53
|
|
Clinical Trial Agreement dated
March 18, 2005 between Amarin Neuroscience Limited and the
University of Rochester. Pursuant to this agreement the
University is obliged to carry out or to facilitate the carrying
out of a clinical trial research study set forth in a research
protocol on Miraxion in patients with Huntingtons
disease(14)
|
|
4
|
.54
|
|
License and Distribution Agreement
dated December 20, 2002 between Laxdale Limited and Link
Pharmaceuticals Limited(14)
|
|
4
|
.55
|
|
License and Distribution Agreement
dated December 9, 2002 between Laxdale Limited and Juste
S.A.Q.F. (14)
|
|
4
|
.56
|
|
Loan
Note Redemption Agreement dated May, 2005 between
Amarin Investment Holding Limited and the Company.(14)
|
|
4
|
.57
|
|
Services Agreement dated
June 16, 2005 between Icon Clinical Research Limited and
Amarin Neuroscience Limited.(15)
|
|
4
|
.58
|
|
License Agreement dated
December 31, 2005 between Amarin Neuroscience Limited and
Multicell Technologies, Inc.(15)
|
|
4
|
.59
|
|
Consultancy Agreement dated
March 29, 2006 between Amarin Corporation plc and Dalriada
Limited*
|
|
8
|
.1
|
|
Subsidiaries of the Company*
|
|
11
|
.1
|
|
Code of Ethics*
|
|
12
|
.1
|
|
Certification of Richard A.B.
Stewart required by Rl
15d-14(a) of
the Securities Exchange Act of 1934, as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002*
|
|
|
|
|
|
|
12
|
.2
|
|
Certification of Alan Cooke
required by
Rule 15d-14(a)
of the Securities Exchange Act of 1934, as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002*
|
|
13
|
.1
|
|
Certification of Richard A. B.
Stewart required by Section 1350 of Chapter 63 of
Title 18 of the United States Code, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002*
|
|
13
|
.2
|
|
Certification of Alan Cooke
required by Section 1350 of Chapter 63 of
Title 18 of the United States Code, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002*
|
|
14
|
.1
|
|
Consent of PricewaterhouseCoopers
LLP*
|
|
14
|
.2
|
|
Consent of Ernst & Young
LLP*
|
|
|
|
* |
|
Filed herewith |
|
|
|
Confidential treatment requested (the confidential portions of
such exhibits have been omitted and filed separately with the
Securities and Exchange Commission) |
|
(1) |
|
Incorporated herein by reference to certain exhibits to the
Companys Registration Statement on
Form F-1,
File
No. 33-58160,
filed with the Securities and Exchange Commission on
February 11, 1993. |
|
(2) |
|
Incorporated herein by reference to Exhibit(a)(i) to the
Companys Registration Statement on Post-Effective
Amendment No. 1 to
Form F-6,
File
No. 333-5946,
filed with the Securities and Exchange Commission on
October 8, 1998. |
|
(3) |
|
Incorporated herein by reference to Exhibit a)(ii) to the
Companys Registration Statement on Post-Effective
Amendment No. 2 to
Form F-6,
File
No. 333-5946,
filed with the Securities and Exchange Commission on
September 26, 2002. |
|
(4) |
|
Incorporated herein by reference to certain exhibits to the
Companys Annual Report on
Form 20-F
for the year ended December 31, 1999, filed with the
Securities and Exchange Commission on June 30, 2000. |
|
(5) |
|
Incorporated herein by reference to certain exhibits to the
Companys Registration Statement on
Form F-3,
File
No. 333-13200,
filed with the Securities and Exchange Commission on
February 22, 2001. |
|
(6) |
|
Incorporated herein by reference to certain exhibits to the
Companys Annual Report on
Form 20-F
for the year ended December 31, 2000, filed with the
Securities and Exchange Commission on July 2, 2001. |
|
(7) |
|
Incorporated herein by reference to certain exhibits to the
Companys Annual Report on
Form 20-F
for the year ended December 31, 2001, filed with the
Securities and Exchange Commission on May 9, 2002. |
|
(8) |
|
Incorporated herein by reference to certain exhibits to the
Companys Registration Statement on Pre-Effective Amendment
No. 2 to
Form F-3,
File
No. 333-13200,
filed with the Securities and Exchange Commission on
November 19, 2001. |
|
(9) |
|
Incorporated herein by reference to certain exhibits to the
Companys Registration Statement on
Form S-8,
File
No. 333-101775,
filed with the Securities and Exchange Commission on
December 11, 2002. |
|
|
|
(10) |
|
Incorporated herein by reference to certain exhibits to the
Companys Annual Report on
Form 20-F
for the year ended December 31, 2002, filed with the
Securities and Exchange Commission on April 24, 2003. |
|
(11) |
|
These agreements are no longer in effect as a result of
superseding agreements entered into by the Company. |
|
(12) |
|
Incorporated herein by reference to certain exhibits to the
Companys Annual Report on
Form 20-F
for the year ended December 31, 2003, filed with the
Securities and Exchange Commission on March 31, 2004. |
|
(13) |
|
Incorporated herein by reference to certain exhibits to the
Companys Registration Statement on
Form F-3,
File
No. 333-121431,
filed with the Securities and Exchange Commission on
December 20, 2004. |
|
(14) |
|
Incorporated herein by reference to certain exhibits to the
Companys Annual Report on
Form 20-F
for the year ended December 31, 2004, filed with the
Securities and Exchange Commission on April 1, 2005. |
|
(15) |
|
Incorporated herein by reference to certain exhibits to the
Companys Registration Statement on
Form F-3,
File
No. 333-131479,
filed with the Securities and Exchange Commission on
February 2, 2006. |
|
(16) |
|
Incorporated by reference herein to certain exhibits in the
Companys report on
Form 6-K,
filed with the Securities and Exchange Commission on
December 12, 2005. |
|
(17) |
|
Incorporated by reference herein to certain exhibits in the
Companys report on
Form 6-K,
filed with the Securities and Exchange Commission on
December 28, 2005. |