<R>
As filed
with the Securities and Exchange Commission on January 26, 2010
Registration
No. 333-163704
</R>
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
<R>
Amendment
No. 1
to
</R>
FORM
F-1
REGISTRATION
STATEMENT UNDER THE SECURITIES ACT OF 1933
AMARIN
CORPORATION PLC
(Exact
name of Registrant as specified in its charter)
|
England
and Wales
(State
or other jurisdiction
of
incorporation or organization)
|
2834
(Primary
Standard Industrial
Classification
Code Number)
|
Not
Applicable
(I.R.S.
Employer
Identification
No.)
|
First
Floor, Block 3, The Oval
Shelbourne
Road, Ballsbridge
Dublin
4, Ireland
+353
1 6699 020
(Address
and telephone number of Registrant’s principal executive offices)
Mr.
Donald J. Puglisi
Managing
Director
Puglisi
& Associates
850
Library Avenue, Suite 204
Newark,
Delaware 19711
1-302-738-6680
(Name,
address, and telephone number of agent for service)
Please
send copies of all communications to:
William
M. Hartnett, Esq.
Cahill Gordon & Reindel
LLP
80
Pine Street
New
York, New York 10005
1-212-701-3000
Approximate
date of commencement of proposed sale to the public: As soon as practicable
after the effective date of this registration statement.
If any of
the securities being registered on this form are to be offered on a delayed or
continuous basis pursuant to Rule 415 under the Securities Act of 1933, check
the following box. x
If this
Form is filed to register additional securities for an offering pursuant to Rule
462(b) under the Securities Act, check the following box and list the Securities
Act registration statement number of the earlier effective registration
statement for the same offering. o
If this
Form is a post-effective amendment filed pursuant to Rule 462(c) under the
Securities Act, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same
offering. o
If this
Form is a post-effective amendment filed pursuant to Rule 462(d) under the
Securities Act, check the following box and list the Securities Act registration
statement number of the earliest effective registration statement for the same
offering. o
CALCULATION
OF REGISTRATION FEE
|
Title
of each class of securities
to
be registered
|
Amount
to
be
registered (2)
|
Proposed
maximum
aggregate
price per
unit
(3)
|
Proposed
maximum
aggregate
offering
price
(3)
|
Amount
of
registration
fee (4)
|
||||
|
Ordinary
Shares, par value £0.50 per share(1)
|
119,512,556
shares
|
$1.23
|
$147,000,444
|
$8,202.62
|
(1) The
Ordinary Shares will be represented by American Depositary Shares (“ADSs”), each
of which currently represents one Ordinary Share. A separate
Registration Statement on Form F-6 (Registration No. 333-147660) has
been filed for the registration of ADSs issuable upon deposit of the Ordinary
Shares.
(2) Pursuant
to Rule 416(a) of the Securities Act of 1933, as amended, this registration
statement shall be deemed to cover additional securities that may be offered or
issued to prevent dilution resulting from splits, dividends or similar
transactions.
(3) Estimated
solely for the purpose of calculating the registration fee pursuant to
Rule 457(c) promulgated under the Securities Act of 1933, as amended, based
on the average of the high and low sales prices of the ADSs on the Nasdaq
Capital Market on December 9, 2009.
<R>
(4) The
filing fee was paid with the initial filing of the registration statement on
December 14, 2009.
</R>
THE
REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES AS
MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL FILE A
FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT
SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(A) OF THE
SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(A),
MAY DETERMINE.
The
information in this prospectus is not complete and may be
changed. The selling shareholders may not sell the securities offered
hereby until the registration statement filed with the Securities and Exchange
Commission has been declared effective. This prospectus is not an
offer to sell these securities nor is it a solicitation of an offer to buy these
securities in any state where the offer and sale is not permitted.
<R>
Subject
to Completion dated January 26, 2010.
</R>
PROSPECTUS
119,512,556
Ordinary Shares
AMARIN
CORPORATION PLC
From time
to time, the selling shareholders named in this prospectus or their transferees,
pledgees, donees or other successors in interest, may offer an aggregate of
119,512,556 of our ordinary shares, par value £0.50 per share (“Ordinary
Shares”), each represented by one American Depositary Share, or ADS, of Amarin
Corporation plc. The selling shareholders are identified in the table
commencing on page 39. The shares held by these selling
shareholders are being registered hereunder in accordance with previously
disclosed agreements between the Company and these shareholders. No shares are
being registered hereunder for sale by the Company and, therefore, the Company
will not receive any proceeds from the sale of securities under this prospectus,
although we may receive proceeds from the exercise of warrants in respect of
which certain of the Ordinary Shares registered hereby are
issuable.
<R>
Our ADSs
are listed on the Nasdaq Capital Market, the principal trading market for our
securities, under the symbol “AMRN”. On January 25, 2010, the closing
sale price for our ADSs, each representing one Ordinary Share, on the Nasdaq
Capital Market was $1.48 per ADS.
</R>
The ADSs
beneficially owned by the selling shareholders may be offered for sale from time
to time by the selling shareholders directly or in negotiated transactions or
otherwise at fixed prices, at prevailing market prices, at varying prices
determined at the time of sale or at negotiated prices. In addition,
the selling shareholders may from time to time effect sales of ADSs representing
Ordinary Shares in one or more types of transactions on the Nasdaq Capital
Market. No representation is made that any ADS will or will not be offered for
sale. We will not receive any proceeds from the sale by the selling
shareholders of Ordinary Shares or ADSs.
INVESTING
IN THE SECURITIES INVOLVES RISKS. SEE “RISK FACTORS” BEGINNING ON
PAGE 5 TO READ ABOUT FACTORS YOU SHOULD CONSIDER BEFORE BUYING THE
SECURITIES. Neither the Securities and Exchange Commission nor any
state securities commission has approved or disapproved of these securities or
determined if this prospectus is truthful or complete. Any
representation to the contrary is a criminal offense.
Amarin
Corporation plc
First
Floor, Block 3, The Oval
Shelbourne
Road, Ballsbridge
Dublin
4, Ireland
+353
1 6699 020
<R>
The date
of this prospectus is January 26, 2010
</R>
TABLE
OF CONTENTS
<R>
|
Page
|
|
|
ABOUT THIS PROSPECTUS
|
1
|
|
WHERE YOU CAN FIND MORE
INFORMATION
|
1
|
|
INCORPORATION BY REFERENCE
|
2
|
|
CAUTIONARY NOTE REGARDING FORWARD-LOOKING
STATEMENTS
|
2
|
|
COMPANY INFORMATION
|
3
|
|
RISK FACTORS
|
5
|
|
IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND
ADVISERS
|
19
|
|
Directors and Senior
Management
|
19
|
|
Advisers
|
20
|
|
Auditors
|
20
|
|
OFFER STATISTICS AND EXPECTED
TIMETABLE
|
20
|
|
KEY INFORMATION
|
20
|
|
Selected Financial Data
|
20
|
|
Capitalization and
Indebtedness
|
20
|
|
Reasons for the Offer and Use of
Proceeds
|
21
|
|
INFORMATION ON THE COMPANY
|
21
|
|
OPERATING AND FINANCIAL REVIEW AND
PROSPECTS
|
22
|
|
DIRECTORS, SENIOR MANAGEMENT AND
EMPLOYEES
|
22
|
|
Directors and Senior
Management
|
22
|
|
Compensation
|
24
|
|
Board Practices
|
26
|
|
Employees
|
28
|
|
Share Ownership
|
28
|
|
MAJOR SHAREHOLDERS AND RELATED PARTY
TRANSACTIONS
|
31
|
|
Major Shareholders
|
31
|
|
Related Party Transactions
|
31
|
|
Interests of Experts and
Counsel
|
31
|
|
FINANCIAL INFORMATION
|
31
|
|
Consolidated Statements and Other Financial
Information
|
31
|
|
Significant Changes
|
31
|
|
THE OFFER AND LISTING
|
36
|
|
Offer and Listing Details
|
36
|
|
Plan of Distribution
|
37
|
|
Markets
|
38
|
|
Selling Shareholders
|
38
|
|
Dilution
|
47
|
|
Expenses of the Issue
|
48
|
|
ADDITIONAL INFORMATION
|
48
|
|
Share Capital
|
48
|
|
Memorandum and Articles of
Association
|
50
|
|
Material Contracts
|
50
|
|
Exchange Controls
|
50
|
|
Taxation
|
50
|
|
Dividends and Paying Agents
|
50
|
|
Documents on Display
|
50
|
|
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT
MARKET RISK
|
51
|
|
DESCRIPTION OF SECURITIES OTHER THAN EQUITY
SECURITIES
|
51
|
|
Debt Securities
|
51
|
|
Warrants and Rights
|
51
|
|
Other Securities
|
52
|
|
American Depositary Shares
|
52
|
|
FINANCIAL STATEMENTS
|
60
|
|
EXPERTS
|
60
|
|
LEGAL MATTERS
|
60
|
|
ENFORCEABILITY OF CIVIL
LIABILITIES
|
60
|
|
DISCLOSURE OF COMMISSION POSITION ON
INDEMNIFICATION FOR SECURITIES ACT LIABILITIES
|
61
|
</R>
-i-
ABOUT
THIS PROSPECTUS
This
prospectus is part of a registration statement on Form F-1 that we filed
with the Securities and Exchange Commission (or the “SEC”) using a “shelf”
registration process. Under this process, the selling shareholders
listed in the table commencing on page 39 may, from time to time, sell the
offered securities described in this prospectus in one or more offerings, up to
a total of 119,512,556 Ordinary Shares. The shares held by these
selling shareholders are being registered hereunder in accordance with
previously disclosed agreements between the Company and these shareholders. No
shares are being registered hereunder for sale by the Company.
We have
not authorized any broker, dealer, salesperson or other person to give any
information or to make any representation regarding any of the securities
offered hereby. You must not rely upon any information or
representation not contained or incorporated by reference in this
prospectus.
This
prospectus does not constitute an offer to sell or the solicitation of an offer
to buy the securities in any jurisdiction in which an offer or solicitation is
not authorized or in which the person making such offer or solicitation is not
qualified to do so or to anyone to whom it is unlawful to make an offer or
solicitation. You should not assume that the information contained in
this prospectus is accurate as of any date other than the date set forth on the
front of the document or that any information we have incorporated by reference
is correct as of any date other than the date of the document incorporated by
reference, even though this prospectus is delivered and securities are sold on
another date.
This
prospectus does not contain all of the information included in the registration
statement and the exhibits thereto. This prospectus includes
statements that summarize the contents of contracts and other documents that are
filed as exhibits to the registration statement. These statements do
not necessarily describe the full contents of such documents, and you should
refer to those documents for a complete description of these
matters. It is important for you to read and consider all information
contained in this prospectus and any prospectus supplement, including the
documents referred to in the section entitled “Incorporation by Reference,”
together with the additional information described below under the heading
“Where You Can Find More Information.”
In this
prospectus, “Amarin,” “Company,” “Group,” “we,” “us” and “our” refer to Amarin
Corporation plc and its consolidated subsidiaries. References to
“U.S. dollars,” “USD” or “$” are to the lawful currency of the United States,
and references to “pounds sterling,” “GBP£” or “£” are to the lawful currency of
the United Kingdom.
WHERE
YOU CAN FIND MORE INFORMATION
<R>
We
file reports, including annual reports on Form 20-F and material
information required to be made public on Form 6-K, and other information with
the SEC pursuant to the rules and regulations of the SEC that apply to foreign
private issuers. You may read and copy any materials filed with the
SEC at its Public Reference Room at 100 F Street, N.E., Washington, D.C.
20549. You may obtain information on the operation of the Public
Reference Room by calling the SEC at 1-800-SEC-0330. The registration
statement of which this prospectus is a part, and other public filings with the
SEC, are also available on the website maintained by the SEC at http://www.sec.gov.
</R>
We
provide Citibank N.A., as depositary under the deposit agreement between us, the
depositary and registered holders of the ADSs, with annual reports, including a
review of operations, and annual audited consolidated financial statements
prepared in conformity with International Financial Reporting Standards, or
IFRS. Upon receipt of these reports, the depositary is obligated to
promptly mail them to all record holders of ADSs. We also furnish to
the 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 has undertaken in the deposit
agreement 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 has also undertaken
in the deposit agreement 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.
INCORPORATION
BY REFERENCE
<R>
The SEC
allows us to incorporate by reference documents we file with the SEC, which
means that we can disclose information to you by referring you to those
documents. The information incorporated by reference is considered to
be part of this prospectus, and we may subsequently file with the SEC certain
supplements or amendments hereto which update and supersede such
information. We incorporate by reference the following
documents:
</R>
|
|
(i)
|
our
annual report on Form 20-F for the fiscal year ended
December 31, 2008 filed on October 22, 2009, as amended by Amendment
No. 1 thereto on Form 20–F/A filed on December 4, 2009;
and
|
<R>
|
|
(ii)
|
our
reports on Form 6-K filed on February 3, 2009, March 11, 2009, April
8, 2009, May 6, 2009, May 15, 2009, May 26, 2009, June 8, 2009, June 10,
2009, July 1, 2009, July 8, 2009, July 9, 2009, July 22, 2009, August 3,
2009, September 3, 2009, September 4, 2009, October 1, 2009, October 5,
2009, October 13, 2009, October 19, 2009, November 6, 2009, November 23,
2009, December 2, 2009, December 14, 2009, December 21, 2009 and January
11, 2010.
|
We will
provide without charge to each person to whom a copy of this prospectus has been
delivered, upon the written or oral request of any such person to us, a copy of
any or all of the documents referred to above that have been or may be
incorporated into this prospectus by reference, including exhibits to such
documents. Requests for such copies should be directed to Amarin
Corporation plc, First Floor, Block 3, The Oval, Shelbourne Road, Ballsbridge,
Dublin 4, Ireland, Attention: Company Secretary, telephone: +353 1 6699 020,
email: investor.relations@ amarincorp.com. Our website address is
http://www.amarincorp.com
and the incorporated reports and other documents may be accessed at http://www.amarincorp.com/investor_relations/sec_filings.441.html. Other
information on, or accessible through, our website is not intended to be part of
this prospectus.
</R>
You
should rely only on the information incorporated by reference or provided in
this prospectus or any prospectus supplement. We have not authorized
anyone else to provide you with different information. This
prospectus is an offer to sell or to buy only the securities referred to in this
prospectus, and only under circumstances and in jurisdictions where it is lawful
to do so. The information contained in this prospectus or any
prospectus supplement is current only as of the date on the front page of those
documents. Also, you should not assume that there has been no change
in our affairs since the date of this prospectus or any applicable prospectus
supplement.
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus includes forward-looking statements. These forward-looking
statements relate, among other things, to our future capital needs, our ability
to acquire or develop additional marketable products, acceptance of our products
by prescribers and end-users, competitive factors, and our marketing and sales
plans. In addition, we may make forward-looking statements in future
filings with the SEC and in written material, press releases and oral statements
issued by or on behalf of us. Forward-looking statements include
statements regarding our intent, belief or current expectations or those of our
management regarding various matters, including statements that include
forward-looking terminology such as “may,” “will,” “should,” “believes,”
“expects,” “anticipates,” “estimates,” “continues,” or similar
expressions.
Forward-looking
statements are subject to risks and uncertainties, certain of which are beyond
our control. Actual results could differ materially from those
anticipated in these forward-looking statements as a result of various factors,
including the factors described in the “Risk Factors” section beginning on
page 5. Some, but not all, of these factors are Amarin’s ability
to maintain sufficient cash and other liquid resources to meet its operating and
any debt service requirements; the success of Amarin’s research and development
activities; decisions by regulatory authorities regarding whether and when to
approve Amarin’s drug applications, as well as their decisions regarding
labelling and other matters that could affect the commercial potential of
Amarin’s products; the speed with which regulatory authorizations, pricing
approvals and product launches may be achieved; whether and when Amarin will be
able to enter into and consummate strategic collaborations with respect to its
products or product candidates on
-2-
acceptable
terms; the success with which developed products may be commercialized;
competitive developments affecting Amarin’s products or product candidates,
including generic and branded competition; 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 and the trend toward managed care and health care cost
containment; Amarin’s ability to protect its patents and other intellectual
property; claims and concerns that may arise regarding the safety or efficacy of
Amarin’s products or product candidates; governmental laws and regulations
affecting Amarin’s operations, including those affecting taxation; risks
relating to the Company’s ability to maintain its Nasdaq listing; general
changes in International Financial Reporting Standards; and growth in costs and
expenses. This list of factors is not exclusive and other risks and
uncertainties may cause actual results to differ materially from those in
forward-looking statements.
All
forward-looking statements in this prospectus are based on information available
to us on the date hereof. We may not be required to publicly update
or revise any forward-looking statements that may be made by us or on our
behalf, in this prospectus or otherwise, whether as a result of new information,
future events or other reasons. Because of these risks and
uncertainties, the forward-looking events and circumstances discussed in this
prospectus might not transpire.
COMPANY
INFORMATION
Our
Company
We are a
clinical-stage biopharmaceutical company with a focus on cardiovascular
disease. Our cardiovascular disease programs capitalize on our
expertise in the field of lipid science and the known therapeutic benefits of
essential fatty acids in cardiovascular disease. We are currently
focusing our efforts on our lead candidate, AMR101, a prescription grade Omega-3
fatty acid, comprising not less than 96% ultra pure ethyl ester of
eicosapentaenoic acid.
<R>
AMR101 is
being progressed to Phase III clinical trials for the treatment of very high
triglycerides in patients with hypertriglyceridemia, the MARINE Study, and for
the treatment of high triglycerides in patients with mixed dyslipidemia, the
ANCHOR Study. Both of these Phase III clinical trials are designed
under Special Protocol Assessment (“SPA”) agreements with the U.S. Food and Drug
Administration. On January 11, 2010, the Company announced that first
patients were enrolled in the MARINE and ANCHOR Studies.
On
October 16, 2009, the Company completed a private placement resulting in gross
proceeds to the Company of $70.0 million. These funds, net of debt
repayment, are being directed at financing the Company’s operations, including
its Phase III clinical trials. More recently, the Company announced
that it has contracted with Medpace, Inc., a contract research organization, to
help execute the cardiovascular Phase III clinical trials and announced that it
is no longer pursuing development of AMR101 for Huntington’s
disease. Studies performed to date for AMR101 demonstrate that AMR101
has a very good safety and tolerability profile. Over 900 patients
have received AMR101 in these studies, the focus of which was Huntington’s
disease, with over 100 receiving continuous treatment for a year or
more.
</R>
AMR101 is
believed to have an impact on a number of biological factors in the body such as
anti-inflammatory mechanisms, cell membrane composition and plasticity,
triglyceride levels and regulation of glucose metabolism.
The
Company’s cardiovascular pipeline also includes potential next generation
product candidates currently under evaluation for preclinical
development.
We also
have a range of clinical and preclinical stage compounds to treat central
nervous system (CNS) disorders, all of which are available for
partnering.
-3-
<R>
As of
December 31, 2009, our unaudited cash balance was approximately $52 million and
all of our debt had been repaid.
</R>
For more
information regarding our business, including our history and development, our
pipeline of drug candidates and our collaboration efforts, please refer to our
Annual Report on Form 20-F filed on October 22, 2009.
Clinical
Cardiovascular-Focused Phase III Clinical Trial Design
The
Company’s intends to run its two Phase III clinical trials
concurrently. Although the trials are to be run concurrently, both of
the trials are separate registration trials seeking to demonstrate safety and
efficacy for different indications.
The
MARINE Study (also known as Study 16) is a multi-center, placebo-controlled,
randomized, double-blind, 12-week study to evaluate the efficacy and safety of 2
grams and 4 grams of AMR101 in patients with fasting triglyceride levels of ≥500
mg/dL. The primary endpoint in the trial is the percentage change in
triglyceride level from baseline to week 12. Following completion of
the 12-week double-blind treatment period, patients will be eligible to enter a
40-week, open-label, extension period. The Company’s Special Protocol
Assessment agreement with the U.S. FDA indicates that this extension period does
not have to be completed in order to support the Company’s New Drug Application
(“NDA”).
The
ANCHOR Study (also known as Study 17) is a multi-center, placebo-controlled,
randomized, double-blind, 12-week study to evaluate the efficacy and safety of 2
grams and 4 grams of AMR101 in patients with high triglyceride levels of ≥200
mg/dL and <500 mg/dL who are on statin therapy. The primary
endpoint in the trial is the percentage change in triglyceride level from
baseline to week 12. In order to seek approval for the treatment of
high triglycerides in patients with mixed dyslipidemia indication, a follow-on
outcome study is required to be substantially underway prior to the NDA
submission. However, the results of this outcome study are not
required for approval of this indication.
The
Company currently anticipates submitting NDA’s for both indications prior to the
end of 2012.
Corporation
Information
Amarin
Corporation plc (formerly Ethical Holdings plc) is a public limited company
listed in the U.S. on the Nasdaq Capital Market. Amarin was
originally incorporated in England as a private limited company on March 1,
1989 under the Companies Act 1985, and re-registered in England as a public
limited company on March 19, 1993.
Our
registered office is located at 110 Cannon Street, London, EC4N 6AR,
England. Our principal executive offices are located at First Floor,
Block 3, The Oval, Shelbourne Road, Ballsbridge, Dublin 4, Ireland and our
telephone number is +353−1−6699−010. The directors are responsible
for the maintenance and integrity of our website, www.amarincorp.com. Our
principal research and development facilities are located at 12 Roosevelt
Avenue, Mystic, Connecticut 06355, USA.
-4-
RISK
FACTORS
You
should carefully consider the risks and the information about our business
described below, together with all of the other information included or
incorporated in this prospectus and any prospectus supplement, before buying
securities in this offering. 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 risks and uncertainties
mentioned in the risk factors 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 and Ordinary Shares could
decline.
We
have a history of losses, and we may not be able to attain profitability in the
foreseeable future.
We have
not been profitable in four of the last five fiscal years. For the
fiscal years ended December 31, 2004 and 2005, we reported profits/(losses)
under U.K. GAAP of approximately $3.2 million and $(20.5) million,
respectively. For the fiscal years ended December 31, 2006, 2007 and
2008 we reported losses under IFRS of approximately $26.8 million, $37.8 million
and $20.0 million, respectively. Unless and until marketing approval
is obtained from either the U.S. Food and Drug Administration, which we refer to
as the FDA, or European Medicines Evaluation Agency, which we refer to as the
EMEA, for any of our products, or we are otherwise able to acquire rights to
products that have received regulatory approval or are at an advanced stage of
development and can be readily commercialized, we may not be able to generate
sufficient revenues in future periods to enable us to attain
profitability.
We have
limited operations, assets and financial resources. We currently have
no marketable products or other source of revenues. All of our
current products are in the development stage. The development of
pharmaceutical products is a capital intensive business. Therefore,
we expect to incur expenses without corresponding revenues at least until we are
at an advanced stage of development or are able to obtain regulatory approval
and sell our future products in significant quantities. Moreover, we
anticipate that our spending for product development is likely to increase as we
conduct Phase III clinical trials. This may result in net operating
losses until we can generate an acceptable level of revenues, which we may not
be able to attain. Further, even if we do achieve operating revenues,
there can be no assurance that such revenues will be sufficient to fund
continuing operations. Therefore, we cannot predict with certainty
whether we will ever be able to achieve profitability.
In
addition to advancing our existing development pipeline, we may also acquire
rights to additional products. However, we may not be successful in
doing so. We may need to raise additional capital before we can
acquire any products. There is also a risk that any of our
development stage products we may acquire will not be approved by the FDA or
regulatory authorities in other countries on a timely basis or at
all. The inability to obtain such approvals would adversely affect
our ability to generate revenues.
The
likelihood of success of our business plan must be considered in light of the
problems, expenses, difficulties, complications and delays frequently
encountered in connection with developing and expanding early stage businesses
and the regulatory and competitive environment in which we operate.
If
we cannot find additional capital resources, we will have difficulty in
operating as a going concern and growing our business.
<R>
At
December 31, 2008, we had a cash balance of approximately $14.2
million. On October 19, 2009, Amarin announced it had
consummated a private placement of units for $70 million, consisting of $66.4
million in cash proceeds and $3.6 million from the conversion of
convertible bridge notes. Based upon current business activities, we
forecast having sufficient cash to fund operations for at least a period of 12
months from January 26, 2010.
</R>
We may
also require further funds in the future to implement our long-term growth
strategy recruiting clinical, regulatory and other personnel, and to grow our
business. Our ability to execute our business strategy
and
-5-
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.
The
continued negative economic conditions would likely negatively impact Amarin’s
ability to obtain financing on acceptable terms.
Unfavorable
economic conditions can impact Amarin’s ability to obtain financing on
acceptable terms. If we are unable to obtain financing on acceptable
terms, we may not be able to fund our operations or execute our business
strategy. We are unable to predict the likely duration and severity
of the current disruption in financial markets and adverse economic conditions
in the U.S. and other countries. There can be no assurance that there
will not be a further deterioration in financial markets and confidence in major
economies.
Our
historical financial results do not form an accurate basis for assessing our
current business.
As a
consequence of a number of acquisitions, divestitures and re-organizations in
recent years, our historical financial results do not form an accurate basis
upon which investors should base an assessment of our business and
prospects. We are now focused on the research, development and
commercialization of novel drugs for cardiovascular
disease. Accordingly, our historical financial results reflect a
substantially different business from that currently being
conducted.
We
may have to issue additional equity, leading to shareholder
dilution.
We are
committed to issue equity to the former shareholders of Amarin Neuroscience upon
the successful achievement of specified milestones for the AMR101 development
program (subject to such shareholders’ right to choose cash payment in lieu of
equity). Pursuant to the Amarin Neuroscience share purchase
agreement, further success-related milestones will be payable as
follows:
Upon
receipt of marketing approval in the United States and Europe for the first
indication of any product containing Amarin Neuroscience intellectual property
as secured in the acquisition of Laxdale Limited in 2004, we must
make an aggregate stock or cash payment (at the sole option of each of the
sellers) of GBP£7.5 million for each of the two potential market approvals
(i.e., GBP£15.0 million
maximum). In addition, upon receipt of a marketing approval in the
United States and Europe for any other product using Amarin Neuroscience
intellectual property as secured in the 2004 Laxdale acquisition or for a
different indication of a previously approved product, we must make an aggregate
stock or cash payment (at the sole option of each of the sellers) of GBP£5.0
million for each of the two potential market approvals (i.e., GBP£10.0 million
maximum). The exchange rate as of October 20, 2009 was approximately
$1.6402 per GBP£.
On
October 16, 2009, Amarin consummated a private placement (the “2009 Private
Placement”) of units with several existing and new institutional and accredited
investors for an aggregate consideration of $70 million, consisting of $66.4
million in cash proceeds and $3.6 million from the conversion of convertible
bridge notes. On closing of the 2009 Private Placement, in
consideration for the $66.4 million received in cash, Amarin issued 66.4 million
units. Each unit had a purchase price of $1.00 and consisted of one
ADS and a warrant (collectively, the “2009 Warrants”) to purchase 0.50 of an
ADS. The warrants have a five year term and an exercise price of
$1.50 per ADS. In consideration for the conversion of $3.6 million of
convertible bridge notes, Amarin issued 4.0 million units. In
accordance with the terms of the conversion of the bridge notes, each unit had
purchase price of $0.90 and consisted of one ADS and a 2009
Warrant.
On
October 16, 2009, the holders of the remaining $1.9 million convertible bridge
loan notes elected to have their principal and accrued interest repaid in
cash.
At
closing of the 2009 Private Placement, the non-executive directors Dr. John
Climax, Dr. Bill Mason and Mr. Anthony Russell Roberts resigned as
directors. Such directors were each granted 5,000 stock options per year
of
-6-
service
which vested in full on closing. Since the 2009 Private Placement,
the Company has issued to certain executives of Amarin warrants (the “Executive
Warrants”), having substantially the same terms as the 2009 Warrants, to
purchase an aggregate amount of 904,005 Ordinary Shares.
In May
2009, Amarin announced that it entered into definitive agreements for a private
placement of convertible bridge loan notes (“Initial Bridge Financing”) in the
amount of $2.6 million with certain existing investors in the Company, including
a number of directors of the Company. In July 2009, $0.1 million of
the Initial Bridge Financing was repaid. In August 2009, the date of
maturity on the convertible loans was extended to September 30,
2009. In August 2009, Amarin announced that it had entered into
definitive agreements for a private placement of additional convertible bridge
loan notes (“Additional Bridge Financing”) in the amount of $3.0 million with
certain existing investors in the Company, including a number of directors of
the Company.
The
Initial Bridge Financing and Additional Bridge Financing consist of convertible
notes and warrants (the “Bridge Warrants”) to purchase 3,111,105 shares with an
exercise price of $1.00. The aggregate convertible notes were in the
principal amount of $5.5 million, were to mature on September 30, 2009 and
pay interest at the rate of 8% per annum. In September 2009, the date
of maturity was extended to October 16, 2009. The Bridge
Warrants are in addition to the 2009 Warrants that were issued on conversion of
the convertible bridge loan notes described above.
In May
2008, the Company issued 13,043,479 Ordinary Shares and 8 Series A Preference
Shares in a private placement (the “May 2008 Financing”) of equity to
institutional investors and certain current and former directors for aggregate
consideration of $30,000,000.
In
December 2007, in connection with a financing, the Company
issued five-year warrants (the “2007 Warrants”) to purchase ADSs at
an exercise price of $4.80. Due to anti-dilution provisions in effect
until December 6, 2009, the exercise price of these warrants has been
adjusted to $1.17.
<R>
As at
January 26, 2010 we had 41,217,579 warrants outstanding (including the 2009
warrants, the Executive Warrants, the Bridge Warrants and the 2007 Warrants
described above) with a weighted average exercise price of $1.75 per
share. As at January 26, 2010 we also had outstanding employee
options to purchase 7,797,266 Ordinary Shares at an average exercise price of
$2.71 per share. See page 21 for a summary capitalization table.
</R>
Additionally,
in pursuing our growth strategy, we may either need to issue new equity as
consideration for the acquisition of products, or to otherwise raise additional
capital, in which case equity, debt convertible into equity or debt instruments
may be issued. The creation of new shares may lead to dilution of the
value of the shares held by our current shareholder base.
We
are undergoing significant organizational change. Failure to manage
disruption to the business or the loss of key personnel could have an adverse
effect on our business.
We are
making significant changes to both our management structure and the locations
from which we operate. We opened a new office in Mystic, CT, USA in
September 2008 and we are currently transitioning certain corporate activities
and functions from Dublin, Ireland to Mystic. As a result of this,
morale may be lowered, key employees may be distracted from their usual role and
Amarin business may experience a loss of continuity. This could
result in delays in development projects, failure to achieve managerial targets
or other disruption to the business which could have material adverse affects on
our business and results of operations.
We
may be dependent upon the success of a limited range of products.
If
development efforts for our products are not successful for any indications or
if they are not approved by the FDA, or if adequate demand for our products is
not generated, our business will be materially and adversely
affected. Although we intend to bring additional products forward
from our research and development efforts, even if we are successful in doing
so, the range of products we will be able to commercialize may be
limited. This could restrict our ability to respond to adverse
business conditions. If we are not successful in developing any
future
-7-
product
or products, or if there is not adequate demand for any such products or the
market for such product develops less rapidly than we anticipate, we may not
have the ability to shift our resources to the development of alternative
products. As a result, the limited range of products we intend to
develop could constrain our ability to generate revenues and achieve
profitability.
Our
ability to generate revenues depends on obtaining regulatory approvals for our
products.
In order
to successfully commercialize a product, we or our potential partners will be
required to conduct all tests and clinical trials needed in order to meet
regulatory requirements, to obtain applicable regulatory approvals, and to
prosecute patent applications. The costs of developing and obtaining
regulatory approvals for pharmaceutical products can be
substantial. Our ability to commercialize any of our products in
development is dependent upon the success of development efforts in clinical
studies. If these clinical trials fail to produce satisfactory
results, or if we are unable to maintain the financial and operational
capability to complete these development efforts, we may be unable to generate
revenues. Even if we obtain regulatory approvals, the timing or scope
of any approvals may prohibit or reduce our ability to commercialize products
successfully. For example, if the approval process takes too long, we
may miss market opportunities and give other companies the ability to develop
competing products or establish market dominance. Additionally, the
terms of any approvals may not have the scope or breadth needed for us to
commercialize products successfully. For instance, if we are unable
to receive designation for our product candidates as new chemical entities
(“NCEs”), such products will not be eligible for exclusive marketing periods
which may be available to products designated as NCEs.
We
may not be successful in developing or marketing future products if we cannot
meet extensive regulatory requirements of the FDA and other regulatory agencies
for quality, safety and efficacy.
The
success of our research and development efforts is dependent in part upon the
ability of the Group, its contractors or potential partners, and its products to
meet and to continue to meet regulatory requirements in the jurisdictions where
we or potential partners ultimately intend to sell such products. The
development, manufacture and marketing of pharmaceutical products are subject to
extensive regulation by governmental authorities in the United States, the
European Union, Japan and elsewhere. In the United States, the FDA
generally requires pre-clinical testing and clinical trials of each drug to
establish its safety and efficacy and extensive pharmaceutical development to
ensure its quality before its introduction into the
market. Regulatory authorities in other jurisdictions impose similar
requirements. Amarin will be commencing two Phase III clinical trials
with AMR101 in lowering triglycerides and continues its ongoing studies and
plans for future toxicology, pharmacology and metabolism studies of AMR101, by
way of utilizing a clinical research organization (“CRO”). The
process of obtaining regulatory approvals is lengthy and expensive and the
issuance of such approvals is uncertain. The commencement and rate of
completion of clinical trials and the timing of obtaining marketing approval
from regulatory authorities may be delayed by many factors,
including:
|
·
|
the
inability to manufacture sufficient quantities of qualified materials
under current good manufacturing practices for use in clinical
trials;
|
|
·
|
slower
than expected rates of patient
recruitment;
|
|
·
|
the
inability to observe patients adequately after
treatment;
|
|
·
|
changes
in regulatory requirements for clinical or preclinical
studies;
|
|
·
|
the
lack of effectiveness during clinical
trials;
|
|
·
|
unforeseen
safety issues emerge in clinical or preclinical
studies;
|
|
·
|
delay,
suspension, or termination of a trial by the institutional review board
responsible for overseeing the study at a particular study
site;
|
-8-
|
·
|
unanticipated
changes to the requirements imposed by regulatory authorities on the
extent, nature or timing of studies to be conducted on quality, safety and
efficacy;
|
|
·
|
the
inability of the CRO to execute the Phase III clinical trials for any
reason; 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 or potential partners conduct may not provide sufficient safety and
effectiveness data to obtain the requisite regulatory approvals for product
candidates. The failure of clinical trials to demonstrate safety and
effectiveness for our desired indications could harm the development of that
product candidate as well as other product candidates, and our business and
results of operations would suffer. For example, the efficacy results
of Amarin’s AMR101 Phase III clinical trials for the treatment of Huntington’s
disease were negative (despite the findings of good safety and tolerability
profile), which required Amarin to rethink its strategy and to shift the focus
of AMR101 to the treatment of cardiovascular disease.
Any
approvals that are obtained may be limited in scope, or may be accompanied by
burdensome post-approval study or other requirements. This could
adversely affect our ability to earn revenues from the sale of such
products. Even in circumstances where products are approved by a
regulatory body for sale, the regulatory or legal requirements may change over
time, or new safety or efficacy information may be identified concerning a
product, which may lead to the withdrawal of a product from the
market. Additionally, even after approval, a marketed drug and its
manufacturer are subject to continual review. The discovery of
previously unknown problems with a product or manufacturer may result in
restrictions on that product or manufacturer, including withdrawal of the
product from the market, which would have a negative impact on our potential
revenue stream.
After
approval, our products will be subject to extensive government
regulation.
Once a
product is approved, numerous post-approval requirements apply. Among
other things, the holder of an approved New Drug Application (“NDA”) or other
license is subject to periodic and other monitoring and reporting obligations
enforced by the FDA and other regulatory bodies, including obligations to
monitor and report adverse events and instances of the failure of a product to
meet the specifications in the approved application. Application
holders must also submit advertising and other promotional material to
regulatory authorities and report on ongoing clinical trials.
With
respect to sales and marketing activities by our partners, advertising and
promotional materials must comply with FDA rules in addition to other
potentially applicable federal and local laws in the United States and in other
countries. In the United States, the distribution of product samples
to physicians must comply with the requirements of the U.S. Prescription Drug
Marketing Act. Manufacturing facilities remain subject to FDA
inspection and must continue to adhere to the FDA’s current good manufacturing
practice requirements. Application holders must obtain FDA approval
for product and 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 or our potential partners comply with FDA and other re-
-9-
quirements,
new information regarding the safety or effectiveness of a product could lead
the FDA to modify or withdraw a product approval. Adverse regulatory
action, whether pre- or post-approval, can potentially lead to product liability
claims and increase our product liability exposure. We or our
potential partners must also compete against other products in qualifying for
reimbursement under applicable third party payment and insurance
programs.
Our
future products may not be able to compete effectively against those of our
competitors.
The
pharmaceutical industry is highly competitive. If we are successful
in completing the development of any of our products, we may face competition to
the extent other pharmaceutical companies have on the market or are able to
develop products for the treatment of similar indications. Potential
competitors in this market include companies with greater resources and name
recognition than us. Furthermore, to the extent we are able to
acquire or develop additional marketable products in the future such products
will compete with a variety of other products within the United States or
elsewhere, possibly including established drugs and major brand
names. Competitive factors, including generic competition, could
force us to lower prices or could result in reduced sales. In
addition, new products developed by others could emerge as competitors to our
future products. Products based on new technologies or new drugs
could render our products obsolete or uneconomical.
Our
potential competitors both in the United States and Europe include large,
well-established pharmaceutical companies, specialty pharmaceutical sales and
marketing companies, and specialized cardiovascular and neurology
companies. In addition, we may compete with universities and other
institutions involved in the development of technologies and products that may
compete with ours. Many of our competitors will likely have greater
resources than us, including financial, product development, marketing,
personnel and other resources. Should a competing product obtain
marketing approval prior to any of our products, this would significantly erode
the projected revenue streams for our product.
The
success of our future products will also depend in large part on the willingness
of physicians to prescribe these products to their patients. Our
future products may compete against products that have achieved broad
recognition and acceptance among medical professionals. In order to
achieve an acceptable level of subscriptions for our future products, we must be
able to meet the needs of both the medical community and end users with respect
to cost, efficacy and other factors.
Our
supply of products for clinical trials and ultimately for commercial supply is
dependent upon relationships with manufacturers and key suppliers.
We have
no in-house manufacturing capacity and, to the extent we are successful in
completing the development of our products and/or acquiring or developing other
marketable products in the future, we will be obliged to rely on contract
manufacturers to produce our products. We cannot assure you that we
will successfully manufacture any product we may develop, either independently
or under manufacturing arrangements, if any, with third party
manufacturers. Moreover, if any manufacturer should cease doing
business with us or experience delays, shortages of supply or excessive demands
on their capacity, we may not be able to obtain adequate quantities of product
in a timely manner, or at all. Manufacturers are required to comply
with current NDA commitments and good manufacturing practices requirements
enforced by the FDA, and similar requirements of other countries. The
failure by a manufacturer to comply with these requirements could affect its
ability to provide us with product.
Any
manufacturing problem or the loss of a contract manufacturer could be disruptive
to our operations and result in lost sales. Additionally, we will be
reliant on third parties to supply the raw materials needed to manufacture our
potential products. Any reliance on suppliers may involve several
risks, including a potential inability to obtain critical materials and reduced
control over production costs, delivery schedules, reliability and
quality. Any unanticipated disruption to future contract manufacture
caused by problems at suppliers could delay shipment of products, increase our
cost of goods sold and result in lost sales.
In the
past and currently, we purchase all API for AMR101 from a single supplier with a
single manufacturing facility. While we have contractual freedom to
source API elsewhere, there is no guarantee we will either be
-10-
successful
in identifying alternative supplier(s) or that such future supplier(s) will have
the manufacturing capacity to meet future requirements. Our current
supplier currently does not have sufficient manufacturing capacity to meet
expected future commercial supply requirements and we cannot assure you that it
or an alternative supplier will have the necessary capacity to meet our
requirements.
We
may not be able to grow our business unless we can acquire or in-license new
products.
During
recent years, we pursued a strategy of product acquisitions and in-licensing in
order to supplement our own research and development activity. Our
success in this regard will be dependent on our ability to identify other
companies that are willing to sell or license product lines to us. We
will be competing for these products with other parties, many of whom have
substantially greater financial, marketing and sales resources than we
do. Even if suitable products are available, depending on competitive
conditions we may not be able to acquire rights to additional products on
acceptable terms, or at all. Our potential inability to acquire
additional products or successfully introduce new products could have a material
adverse effect on our business.
In
order to commercialize our future products, we may need to find a collaborative
partner to help market and sell our products.
Our
strategy for commercializing currently anticipates that we will enter into
collaborative arrangements with one or more pharmaceutical companies that have
product development resources and expertise, established distribution systems
and direct sales forces to successfully market our products. If so,
we will be reliant on one or more of these strategic partners to generate
revenue on our behalf.
We may
not be successful in finding a collaborative partner to help market and sell our
products, or may be delayed in doing so, in which case we would not receive
revenue or royalties on the timeframe and to the extent that we currently
anticipate.
The
carrying value of our EN101 intangible asset is dependent on the success or
failure of partnering activities and future development work.
<R>
At June 30, 2009, our EN101 intangible
asset had a carrying value of $21.4 million. Subsequent to that date
the Company announced its heightened strategic and operating focus on
cardiovascular disease and its cessation of research and development of product
candidates in the field of central nervous system disorders. Furthermore, the
Company has undertaken an effort to out-license its EN101 intangible
asset. The Company is in discussions with various companies that have
expressed an interest in acquiring rights to the EN101 intangible
asset. As of January 26, 2010, the Company has not received
any acceptable offers. Unless such expressions of interest
advance into at least one binding offer on terms which are acceptable to the
Company, the Company plans a non-cash write down of the value of this intangible
asset. This write down will occur in the second half of 2009 and is
likely to represent a write down of all, or substantially all, of the prior
carrying value of this intangible asset. This write down will
increase net loss and reduce net assets of Amarin by the amount of the
impairment. There can be no assurance that we will be successful in
our efforts to partner or out-license EN101.
</R>
The
planned expansion of our business may strain our resources.
We
currently operate with limited resources; the addition of any new products could
require a significant expansion of our operations, including the recruitment,
hiring and training of additional personnel, particularly those with a clinical
or regulatory background. Any failure to recruit necessary personnel
could have a material adverse effect on our business. Additionally,
the expansion of our operations and work force could create a strain on our
financial and management resources and it may require us to add management
personnel.
We
may incur potential liabilities relating to discontinued operations or
products.
In
October 2003, we sold Gacell Holdings AB, the Swedish holding company of Amarin
Development AB, which we refer to as ADAB, our Swedish drug development
subsidiary, to Watson Pharmaceuticals, Inc. In February 2004, we sold
our U.S. subsidiary, Amarin Pharmaceuticals Inc., and certain assets, to
Valeant. In connection
-11-
with
these transactions, we provided a number of representations and warranties to
Watson and Valeant regarding the respective businesses sold to them, and other
matters, and we undertook to indemnify Watson and Valeant under certain
circumstances for breaches of such representations and warranties. We
are not aware of any circumstances which could reasonably be expected to give
rise to an indemnification obligation under our agreements with either Watson or
Valeant. However, we cannot predict whether matters may arise in the
future which were not known to us and which, under the terms of the relevant
agreements, could give rise to a claim against us.
We
will be dependent on patents, proprietary rights and
confidentiality.
Because
of the significant time and expense involved in developing new products and
obtaining regulatory approvals, it is very important to obtain patent and trade
secret protection for new technologies, products and processes. Our
ability to successfully implement our business plan will depend in large part on
our ability to:
|
·
|
acquire
patented or patentable products and
technologies;
|
|
·
|
obtain
and maintain patent protection or market exclusivity 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 do not believe our business activities infringe upon the rights of others,
nor are we aware of any pending or contemplated actions to such effect, it is
possible that one or more of our products infringe, or any of our products in
development will infringe upon, the intellectual property rights of
others. We may also be subject to claims of alleged infringement of
intellectual property rights asserted by third parties whose products or
services we use or combine with our own intellectual property and for which we
may have no right to intellectual property indemnification. Our
competitors may also assert that our products infringe intellectual property
rights held by them. The expense and time of defending against
infringement claims can be significant. Not only can such actions
divert management’s attention, but also expose the company to damages and
potential injunctive relief which, if granted, could prohibit us from
undertaking certain activities or using technologies essential to our business.
In addition, because patent applications are maintained under conditions of
confidentiality and can take many years to issue, our products may allegedly
infringe upon patent applications that are currently pending of which we are
unaware and which may later result in issued patents. If a third
party obtains a patent that prevent the sale of our current or future products,
we may be required to enter into royalty or licensing arrangements, which may
not be available on terms acceptable to us if at all, 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
-12-
specialized
nature of our business, as our business plan progresses we will be highly
dependent upon our ability to attract and retain qualified scientific, technical
and key management personnel. There is intense competition for
qualified personnel in the areas of our activities. In this
environment, we may not be able to attract and retain the personnel necessary
for the development of our business, particularly if we do not achieve
profitability. The failure to recruit key scientific, technical and
management personnel would be detrimental to our ability to implement our
business plan.
We
are subject to continuing potential product liability.
Although
we disposed of the majority of our former marketed products during 2003 and
2004, we remain subject to the potential risk of product liability claims
relating to the manufacturing and marketing of our former products during the
period prior to their divestiture. Any person who is injured as a
result of using one of our former products during our period of ownership may
have a product liability claim against us without having to prove that we were
at fault. The potential for liability exists despite the fact that
our former subsidiary, Amarin Pharmaceuticals Inc. conducted all sales and
marketing activities with respect to such products. Although we have
not retained any liabilities of Amarin Pharmaceuticals Inc. in this regard, as
the prior holder of ownership rights to such former products, third parties
could seek to assert potential claims against us. Since we
distributed and sold our products to a wide number of end users, the risk of
such claims could be material.
We do not
at present carry product liability insurance to cover any such
risks. If we were to seek insurance coverage, we may not be able to
maintain product liability coverage on acceptable terms if our claims experience
results in high rates, or if product liability insurance otherwise becomes
costlier or unavailable because of general economic, market or industry
conditions. If we add significant products to our portfolio, we will
require product liability coverage and may not be able to secure such coverage
at reasonable rates or at all.
Product
liability claims could also be brought by persons who took part in clinical
trials involving our current or former development stage products. A
successful claim brought against us could have a material adverse effect on our
business.
Amarin
was responsible for the sales and marketing of Permax from May 2001 until
February 2004. On May 17, 2001, Amarin acquired the U.S. sales and
marketing rights to Permax from Elan. An affiliate of Elan had
previously obtained the licensing rights to Permax from Eli Lilly and Company in
1993. Eli Lilly originally obtained approval for Permax on December
30, 1988, and has been responsible for the manufacture and supply of Permax
since that date. On February 25, 2004, Amarin sold its U.S.
subsidiary, Amarin Pharmaceuticals, Inc., including the rights to Permax, to
Valeant Pharmaceuticals International.
In late
2002, Eli Lilly, as the holder of the NDA for Permax, received a recommendation
from the FDA to consider making a change to the package insert for Permax based
upon the very rare observation of cardiac valvulopathy in patients taking
Permax. While Permax has not been definitely proven as the cause of
this condition, similar reports have been notified in patients taking other
ergot-derived pharmaceutical products, of which Permax is an
example. In early 2003, Eli Lilly amended the package insert for
Permax to reflect the risk of cardiac valvulopathy in patients taking Permax and
also sent a letter to a number of doctors in the United States describing this
potential risk. Causation has not been established, but is thought to
be consistent with other fibrotic side effects observed in Permax.
On March
29, 2007, the FDA announced that the manufacturers of pergolide drug products
will voluntarily remove these drug products, including Permax, from the
market. Further information about the removal of Permax and other
pergolide drug products is available on the FDA’s website.
During
2008, two lawsuits alleging claims related to cardiac valvulopathy and Permax
were filed in March and August respectively. One of the lawsuits was
dismissed in February 2009 and the remaining case is currently pending in the
United States. Among others, Eli Lilly, Elan, Valeant, Amarin
Pharmaceuticals, and Amarin are named as defendants in this lawsuit, however
Amarin has not been formally served with the complaint from the
lawsuit. In addition, six cases alleging claims related to cardiac
valvulopathy and Permax were filed in April 2008 in
-13-
the
United States and currently remain pending. Eli Lily, Valeant, Amarin
Pharmaceuticals and unidentified parties are named as defendants in these cases,
and are defending against the claims and allegations. Amarin has not
been named as defendant or served with the complaints from these
cases.
During
2009, two lawsuits alleging claims related to cardiac valvulopathy and Permax
were filed in March and are currently pending in the United
States. Eli Lilly, Elan, Valeant, Amarin Pharmaceuticals, Amarin and
other parties are named as defendants in these lawsuits. Amarin has
not been formally served with the complaint from these lawsuits. A
third lawsuit, also filed in March, was dismissed in September only as to Amarin
for the plaintiff’s failure to prosecute the case against Amarin.
Ten other
claims related to cardiac valvulopathy and Permax and one claim related to
compulsive gambling and Permax are or were being threatened against Eli Lilly,
Elan, and/or Valeant, and could possibly implicate Amarin.
We have
reviewed the position and having taken external legal advice and consider the
potential risk of significant liability arising for Amarin from these legal
actions to be remote. No provision is booked in the accounts at June
30, 2009.
The
price of our ADSs and Ordinary Shares may be volatile.
<R>
The stock
market has from time to time experienced significant price and volume
fluctuations that may be unrelated to the operating performance of particular
companies. In addition, the market prices of the securities of many
pharmaceutical and medical technology companies have been especially volatile in
the past, and this trend is expected to continue in the future. Our
ADSs may also be subject to volatility as a result of their limited trading
market. At January 26, 2010 we had 98,178,571 ADSs representing
Ordinary Shares outstanding and 623,411 Ordinary Shares outstanding (which are
not held in the form of ADSs). There is a risk that there may not be
sufficient liquidity in the market to accommodate significant increases in
selling activity or the sale of a large block of our securities. Our
ADSs have historically had limited trading volume, which may also result in
volatility. During the twelve-month period ending December 31, 2009,
the average daily trading volume for our ADSs was 15,432.
</R>
If our
public float and the level of trading remain at limited levels over the long
term, this could result in volatility and increase the risk that the market
price of our ADSs and Ordinary Shares may be affected by factors such
as:
|
·
|
the
announcement of new products or
technologies;
|
|
·
|
innovation
by us or our competitors;
|
|
·
|
developments
or disputes concerning any future patent or proprietary
rights;
|
|
·
|
actual
or potential medical results relating to our products or our competitors’
products;
|
|
·
|
interim
failures or setbacks in product
development;
|
|
·
|
regulatory
developments in the United States, the European Union or other
countries;
|
|
·
|
currency
exchange rate fluctuations; and
|
|
·
|
period-to-period
variations in our results of
operations.
|
A
Share price of less than $1.00 may impact the company’s Nasdaq
listing.
Amarin is
currently trading above $1.00; however, in the period from October 6, 2008 until
April 7, 2009 Amarin was trading beneath $1.00. Due to the current
state of capital markets, on October 16, 2008, Nasdaq and the
-14-
SEC
suspended the application of the $1.00 minimum bid price rule until April 20,
2009. This suspension was further extended to July 19,
2009. Nasdaq noted that on September 30, 2008, 64 securities were
trading at less than $1 while in mid November, 2008 that number had jumped to
344. The suspension was removed on July 20, 2009. If
Amarin’s closing bid price is less than $1.00 for 30 consecutive trading days,
Amarin will receive a Nasdaq staff deficiency letter indicating that the Company
is not in compliance with the minimum bid price requirement for continued
listing. Such a letter would trigger an automatic 180 calendar day
period within which the company could regain compliance. Compliance
is regained at any time during this period, if the Amarin closing bid price is
$1.00 per share or more for a minimum of 10 consecutive trading
days. If compliance cannot be demonstrated by the end of the 180
days, Amarin will be afforded an additional 180 calendar day compliance period
if Nasdaq determines at that time that the Company meets the remaining Nasdaq
Capital Market initial listing criteria in Rule 5505, except for the bid price
requirement. If Amarin was not eligible for an additional compliance
period, Nasdaq would provide written notification that the Company’s securities
will be delisted. At that time, Amarin could appeal Nasdaq’s
determination to delist its securities to a Listing Qualifications
Panel.
The
issuances of ADSs and Ordinary Shares upon the conversion or exercise of our
securities will dilute the ownership interest of existing stockholders,
including stockholders who had previously exercised their warrants.
The
issuances of ADSs and Ordinary Shares in connection with the exercise of our
warrants will dilute the ownership interest of existing
stockholders. Any sales in the public market of the ADSs and Ordinary
Shares issuable upon such exercise could adversely affect prevailing market
prices of our ADSs and Ordinary Shares.
Future
sales of our ADSs and/or Ordinary Shares in the public market could lower the
market price for our ADSs and/or Ordinary Shares.
In the
future, we may sell additional ADSs and/or Ordinary Shares to raise capital or
pursuant to contractual obligations. See “We may have to issue
additional equity, leading to shareholder dilution.” We cannot
predict the size of future issuances or sales of our ADSs and/or Ordinary Shares
to raise capital or the effect, if any, that they may have on the market price
for our ADSs and/or Ordinary Shares. The issuances and sales of
substantial amounts of ADSs and/or Ordinary Shares, or the perception that such
issuances and sales may occur, could adversely affect the market price of our
ADSs and/or Ordinary Shares.
We
may lose our foreign private issuer status in the future, which could result in
significant additional costs and expenses.
We are a
“foreign private issuer,” as such term is defined in Rule 405 under the U.S.
Securities Act of 1933, as amended, or the Securities Act, and, therefore, we
are not required to comply with all the periodic disclosure and current
reporting requirements of the U.S. Securities Exchange Act of 1934, as amended,
and related rules and regulations. Under Rule 405, the determination
of foreign private issuer status is made annually on the last business day of an
issuer’s most recently completed second fiscal quarter and, accordingly, the
next determination will be made with respect to Amarin on June 30,
2010. However, there is a significant risk that we will lose our
foreign private issuer status on June 30, 2010.
In the
future, we would lose our foreign private issuer status if a majority of our
shareholders or of our directors are U.S citizens or residents and we continue
to fail to meet additional requirements necessary to avoid loss of foreign
private issuer status. The regulatory and compliance costs to us
under U.S. securities laws as a U.S. domestic issuer may be significantly more
than costs we incur as a foreign private issuer. If we are not a
foreign private issuer, we will be required to file periodic reports and
registration statements on U.S. domestic issuer forms with the U.S. Securities
and Exchange Commission, which are more detailed and extensive than the forms
available to a foreign private issuer. We may also be required to
prepare our financial statements in accordance with U.S. generally accepted
accounting principles and modify certain of our policies to comply with good
governance practices associated with U.S. domestic issuers. Such
conversion and modifications will involve additional costs. In
addition we may lose our ability to rely upon exemptions from certain corporate
governance requirements on U.S. stock exchanges that are available to foreign
private issuers.
-15-
U.S.
Holders of our Ordinary Shares or ADSs could be subject to material adverse tax
consequences if we are considered a PFIC for U.S. federal income tax
purposes.
There is
a risk that we will be classified as a passive foreign investment company, or
“PFIC”, for U.S. federal income tax purposes. Our status as a PFIC
could result in a reduction in the after-tax return to U.S. Holders of our
Ordinary Shares or ADSs and may cause a reduction in the value of such
shares. We will be classified as a PFIC for any taxable year in which
(i) 75% or more of our gross income is passive income or (ii) at least 50% of
the average value of all our assets produces or are held for the production of
passive income. For this purpose, passive income includes interest,
gains from the sale of stock, and royalties that are not derived in the active
conduct of a trade or business. Because we receive interest and may
receive royalties, there is a risk that we will be considered a PFIC under the
income test described above. In addition, because of our cash
position and our ownership of patents, there is a risk that we will be
considered a PFIC under the asset test described above. While we
believe that the PFIC rules were not intended to apply to companies such as us
that focus on research, development and commercialization of drugs, no assurance
can be given that the U.S. Internal Revenue Service or a U.S. court would
determine that, based on the composition of our income and assets, we are not a
PFIC currently or in the future. If we were classified as a PFIC,
U.S. holders of our Ordinary Shares or ADSs could be subject to greater U.S.
income tax liability than might otherwise apply, imposition of U.S. income tax
in advance of when tax would otherwise apply, and detailed tax filing
requirements that would not otherwise apply. The PFIC rules are
complex and a U.S. Holder of our Ordinary Shares or ADSs is urged to consult its
own tax advisors regarding the possible application of the PFIC rules to it in
its particular circumstances.
A
change in our tax residence could have a negative effect on our future
profitability.
Although
we are incorporated in England and Wales, our directors seek to ensure that our
affairs are conducted in such a manner that we are resident in Ireland for Irish
and U.K. tax purposes. It is possible that in the future, whether as
a result of a change in law or the practice of any relevant tax authority or as
a result of any change in the conduct of our affairs following a review by our
directors or for any other reason, we could become, or be regarded as having
become resident in a jurisdiction other than Ireland. Should we cease
to be an Irish tax resident, we may be subject to a charge to Irish capital
gains tax on our assets. Similarly, if the tax residency of any of
our subsidiaries were to change from their current jurisdiction for any of the
reasons listed above, we may be subject to a charge to local capital gains tax
charge on the assets.
U.S.
Holders of our Ordinary Shares or ADSs may be subject to U.S. income taxation at
ordinary income tax rates on undistributed earnings and profits.
Given our
current ownership, we expect that we are a controlled foreign corporation,
(“CFC”) for the taxable year 2008 and we may be classified as a CFC in future
taxable years. If we are classified as a CFC for U.S. federal income
tax purposes, any shareholder that is a U.S. person that owns directly,
indirectly or by attribution, 10% or more of the voting power of our outstanding
shares may be subject to current U.S. income taxation at ordinary income tax
rates on all or a portion of the Company’s undistributed earnings and profits
attributable to “subpart F income.” Such 10% shareholder may also be
taxable at ordinary income tax rates on any gain realized on a sale of Ordinary
Shares or ADS, to the extent of the Company’s current and accumulated earnings
and profits attributable to such shares. The CFC rules are complex
and U.S. Holders of our Ordinary Shares or ADSs are urged to consult their own
tax advisors regarding the possible application of the CFC rules to them in
their particular circumstances.
The
rights of our shareholders may differ from the rights typically offered to
shareholders of a U.S. corporation.
We are
incorporated under English law. The rights of holders of Ordinary
Shares and, therefore, certain of the rights of holders of ADSs, are governed by
English law, including the provisions of the Companies Act 2006, and by our
memorandum and articles of association. These rights differ in
certain respects from the rights of shareholders in typical U.S.
corporations. The principal differences include the
following:
-16-
|
·
|
Under
English law, each shareholder present at a meeting has only one vote
unless demand is made for a vote on a poll, in which each holder gets one
vote per share owned. Under U.S. law, each shareholder
typically is entitled to one vote per share at all
meetings. Under English law, it is only on a poll that the
number of shares determines the number of votes a holder may
cast. You should be aware, however, that the voting rights of
ADSs are also governed by the provisions of a deposit agreement with our
depositary bank.
|
|
·
|
Under
English law, each shareholder generally has preemptive rights to subscribe
on a proportionate basis to any issuance of shares. Under U.S.
law, shareholders generally do not have preemptive rights unless
specifically granted in the certificate of incorporation or
otherwise.
|
|
·
|
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.
|
|
·
|
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.
|
|
·
|
The
quorum requirement for a shareholders’ meeting is a minimum of two persons
present in person or by proxy. Under U.S. law, a majority of
the shares eligible to vote must generally be present (in person or by
proxy) at a shareholders’ meeting in order to constitute a
quorum. Under U.S. law, the minimum number of shares required
for a quorum can be reduced pursuant to a provision in a company’s
certificate of incorporation or bylaws, but typically not below one-third
of the shares entitled to vote at the
meeting.
|
U.S.
shareholders may not be able to enforce civil liabilities against
us.
A number
of our directors and executive officers and those of each of our subsidiaries
are non-residents of the United States, and all or a substantial portion of the
assets of such persons are located outside the United States. As a
result, it may not be possible for investors to effect service of process within
the United States upon such persons or to enforce against them judgments
obtained in U.S. courts predicated upon the civil liability provisions of the
federal securities laws of the United States. We have been advised
by our English
solicitors that there is doubt as to the enforceability in England in original
actions, or in actions for enforcement of judgments of U.S. courts, of civil
liabilities to the extent predicated upon the federal securities laws of the
United States.
Foreign
currency fluctuations may affect our future financial results or cause us to
incur losses.
We
prepare our financial statements in U.S. Dollars. Since our strategy involves
the development of products for the U.S. market, a significant part of our
clinical trial expenditures are denominated in U.S. Dollars and we anticipate
that the majority of our future revenues will be denominated in U.S.
Dollars. However, a significant portion of our costs are denominated
in pounds sterling and euro as a result of our being engaged in activities in
the United Kingdom and the European Union. As a consequence, the
results reported in our financial statements are potentially subject to the
impact of currency fluctuations between the U.S. Dollar on the one hand, and
pounds sterling and euro on the other hand. We are focused on
development activities and do not anticipate generating on-going revenues in the
short-term. Accordingly, we do not engage in significant currency
hedging activities in order to limit the risk of exchange rate
fluctuations. However, if we should commence commercializing any
products in the United States, changes in the relation of the U.S. Dollar to the
pound sterling and/or the euro may affect our
-17-
revenues
and operating margins. In general, we could incur losses if the U.S.
Dollar should become devalued relative to pounds sterling and/or the
euro.
We
do not currently have the capability to undertake marketing, or sales of any
potential products.
We have
not invested in marketing or product sales resources. We cannot
assure you that we will be able to acquire such resources. We cannot
assure you that we will successfully market any product we may develop, either
independently or under marketing arrangements, if any, with other
companies. To the extent that we enter into contractual relationships
with other companies to market our products, if any, the success of such
products may depend on the success of securing and maintaining such contractual
relationships and the efforts of those other companies (and any subcontractors
they engage).
We
have limited personnel to oversee out-sourced contract manufacturing, clinical
testing and the regulatory approval process.
It is
likely that we will also need to hire additional personnel skilled in the
manufacturing, clinical testing and regulatory compliance process if we develop
additional product candidates with commercial potential. We do not
currently have the capability to conduct clinical testing in-house and do not
currently have plans to develop such a capability. We out-source our
clinical testing to contract research organizations. We currently
have a limited number of employees and certain other outside consultants who
oversee the contract research organizations involved in clinical testing of our
compounds.
We
cannot assure you that our limited oversight of the contract research
organizations will suffice to avoid significant problems with the protocols and
conduct of the clinical trials.
We depend
on contract research organizations to conduct our pre-clinical and our clinical
testing. We have engaged and intend to continue to engage third party
contract research organizations and other third parties to help us develop our
drug candidates. Although we have designed the clinical trials for
drug candidates, the contract research organizations will be conducting all of
our clinical trials. As a result, many important aspects of our drug
development programs have been and will continue to be outside of our direct
control. In addition, the contract research organizations may not
perform all of their obligations under arrangements with us. If the
contract research organizations do not perform clinical trials in a satisfactory
manner or breach their obligations to us, the development and commercialization
of any drug candidate may be delayed or precluded. We cannot control
the amount and timing of resources these contract research organizations devote
to our programs or product candidates. The failure of any of these
contract research organizations to comply with any governmental regulations
would substantially harm our development and marketing efforts and delay or
prevent regulatory approval of our drug candidates. If we are unable
to rely on clinical data collected by others, we could be required to repeat,
extend the duration of, or increase the size of our clinical trials and this
could significantly delay commercialization and require significantly greater
expenditures.
Despite
the use of confidentiality agreements and/or proprietary rights agreements,
which themselves may be of limited effectiveness, it may be difficult for us to
protect our trade secrets.
We rely
on trade secrets to protect technology in cases when we believe patent
protection is not appropriate or obtainable. However, trade secrets
are difficult to protect. While we require certain of our academic
collaborators, contractors and consultants to enter into confidentiality
agreements, we may not be able to adequately protect our trade secrets or other
proprietary information.
Potential
technological changes in our field of business create considerable
uncertainty.
We are
engaged in the biopharmaceutical field, which is characterized by extensive
research efforts and rapid technological progress. New developments
in research are expected to continue at a rapid pace in both industry and
academia. We cannot assure you that research and discoveries by
others will not render some or all of our programs or product candidates
uncompetitive or obsolete. Our business strategy is based in part
upon new and
-18-
unproven
technologies to the development of biopharmaceutical products for the treatment
of cardiovascular diseases. We cannot assure you that unforeseen
problems will not develop with these technologies or applications or that
commercially feasible products will ultimately be developed by us.
Third-party
reimbursement and health care cost containment initiatives and treatment
guidelines may constrain our future revenues.
Our
ability to market successfully our existing and future new products will depend
in part on the level of reimbursement that government health administration
authorities, private health coverage insurers and other organizations provide
for the cost of our products and related treatments. Countries in
which our products are sold through reimbursement schemes under national health
insurance programs frequently require that manufacturers and sellers of
pharmaceutical products obtain governmental approval of initial prices and any
subsequent price increases. In certain countries, including the
United States, government-funded and private medical care plans can exert
significant indirect pressure on prices. We may not be able to sell
our products profitably if adequate prices are not approved or reimbursement is
unavailable or limited in scope. Increasingly, third-party payers
attempt to contain health care costs in ways that are likely to impact our
development of products including:
|
·
|
failing
to approve or challenging the prices charged for health care
products;
|
|
·
|
introducing
reimportation schemes from lower priced
jurisdictions;
|
|
·
|
limiting
both coverage and the amount of reimbursement for new therapeutic
products;
|
|
·
|
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;
|
|
·
|
refusing
to provide coverage when an approved product is used in a way that has not
received regulatory marketing approval;
and
|
|
·
|
refusing
to provide coverage when an approved product is not appraised favorably by
the National Institute for Clinical Excellence in the U.K., or similar
agencies in other countries.
|
IDENTITY
OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS
Directors
and Senior Management
<R>
|
Name
|
Position
|
Business Address
|
|
Joseph
S. Zakrzewski
|
Executive
Chairman
|
|
|
Thomas
Lynch
|
Non-Executive
Director
|
First
Floor, Block 3, The
Oval
Shelbourne Road
Ballsbridge
Dublin
4, Ireland
|
|
Dr.
Joseph Anderson
|
Non-Executive
Director
|
|
|
Dr.
Lars Ekman
|
Non-Executive
Director
|
|
|
Dr.
Carl L. Gordon
|
Non-Executive
Director
|
|
|
Dr.
James I. Healy
|
Non-Executive
Director
|
|
|
Dr.
Manus Rogan
|
Non-Executive
Director
|
|
|
Dr.
Declan Doogan
|
Interim
Chief Executive Officer
|
|
|
John
F. Thero
|
Chief
Financial Officer
|
|
|
Tom
Maher
|
Interim
General Counsel and Company Secretary
|
|
|
Dr.
Paresh Soni
|
Senior
Vice President and Head of Development
|
|
|
Conor
Dalton
|
Vice
President, Finance & Principal Accounting Officer
|
</R>
-19-
Advisers
Principal
bankers:
Not
applicable
Legal
advisers:
U.S. Law
Cahill
Gordon & Reindel llp
80 Pine
Street
New York,
New York 10005
U.K. Law
K&L
Gates LLP
110
Cannon Street
London
EC4N 6AR
Auditors
Our
auditors for the years ended December 31, 2006, 2007 and 2008 have been
PricewaterhouseCoopers. Their offices are located at One Spencer
Dock, North Wall, Dublin 1, Ireland.
OFFER
STATISTICS AND EXPECTED TIMETABLE
The
119,512,556 Ordinary Shares offered by this prospectus are being registered on
behalf of the selling shareholders named in this prospectus and may be sold from
time to time following the effective date of the registration statement of which
this prospectus is a part. The selling shareholders may offer to sell
the Ordinary Shares being offered in this prospectus in negotiated transactions
or otherwise at fixed prices, at prevailing market prices at the time of sale,
at varying prices or at negotiated prices.
We have
established an American Depositary Receipt facility pursuant to which holders of
our Ordinary Shares can receive American Depositary Receipts, evidencing ADSs,
against the deposit of their Ordinary Shares with Citibank, N.A., which acts as
depositary on our behalf. The selling shareholders have deposited
their Ordinary Shares in our American Depositary Receipt facility and
consequently may also offer and sell ADSs on the Nasdaq Capital Market at
prevailing market prices.
For more
information on the sale of the Ordinary Shares by the selling shareholders,
please see the section of this prospectus entitled “Plan of
Distribution.”
KEY
INFORMATION
Selected
Financial Data
The
Company’s selected financial data are disclosed under Item 3 of our Annual
Report on Form 20−F for the fiscal year ended December 31, 2008 filed with the
Commission on October 22, 2009 (“2008 Annual Report”), which is incorporated by
reference herein.
Capitalization
and Indebtedness
The
following table sets forth, on an IFRS basis, our capitalization as of June 30,
2009. This table should be read in conjunction with our consolidated
financial statements as of and for the year ended December 31, 2008 set
forth in our 2008 Annual Report, which are incorporated by reference herein,
together with our interim financial
-20-
information
furnished under Form 6-K on December 14, 2009. For the pro forma
capitalization table showing the impact of the 2009 Private Placement, see
“Financial Information — Significant Changes.”
As at
June 30, 2009, Amarin Corporation plc held approximately $1.64 million of
cash balances.
|
Actual
$’000
|
||||
|
Long
Term Debt
|
— | |||
|
Shareholders’
equity:
|
||||
|
Ordinary
Share capital
|
25,928 | |||
|
Treasury
shares
|
(217 | ) | ||
|
Capital
redemption reserve
|
27,633 | |||
|
Other
reserves (share based payments, warrants, etc.)
|
28,142 | |||
|
Share
premium account
|
152,864 | |||
|
Profit
and loss account — (deficit)
|
(220,326 | ) | ||
|
Total
shareholders’ equity
|
14,024 | |||
|
Total
capitalization
|
14,024 | |||
Note
to capitalization table — Non-adjusting event after reporting
period
<R>
Subsequent to the October 2009
financings and subsequent board changes, in December 2009 Amarin announced its
heightened strategic and operating focus on cardiovascular disease and its
cessation of research and development of product candidates in the field of
central nervous system disorders. Furthermore, the Company has undertaken an
effort to out-license its EN101 intangible asset. The Company now
considers the value of its EN101 intangible assets to be impaired. The Company
is in discussions with various companies that have expressed an interest in
acquiring rights to the EN101 intangible asset. As of
January 26, 2010, the Company has not received any acceptable offers.
Unless such expressions of interest advance into at least one binding
offer on terms which are acceptable to the Company, the Company plans a non-cash
write down of the value of this intangible asset. This write down
will occur in the second half of 2009 and is likely to represent a write down of
all, or substantially all, of the prior carrying value of this intangible
asset. This write down will increase net loss and reduce net assets
of Amarin by the amount of the impairment.
</R>
Expenses
associated with the preparation and filing of this registration statement have
been estimated and offset against the share premium account. Details
of these expenses can be found in the section entitled “The Offer and
Listing—Expenses of the Issue” on page 48.
Reasons
for the Offer and Use of Proceeds
All
of the Ordinary Shares offered by this prospectus are being offered by the
selling shareholders listed in the table commencing on
page 38. We will not receive any proceeds from sales of Ordinary
Shares by the selling shareholders, although we may receive proceeds from the
exercise of warrants in respect of which certain of the Ordinary Shares
registered hereby are issuable. We will pay the expenses of the
offering other than any underwriters’ discounts and commissions and any fees and
disbursements of counsel to the selling shareholders. We expect that
the selling shareholders will sell their Ordinary Shares as described under
“Plan of Distribution”.
INFORMATION
ON THE COMPANY
Information
regarding the Company’s history and development, business overview,
organizational structure and property, plant and equipment is disclosed under
Item 4 of the 2008 Annual Report, which is incorporated by reference
herein.
-21-
OPERATING
AND FINANCIAL REVIEW AND PROSPECTS
Information
regarding the Company’s operating results, liquidity and capital resources,
research and development, patents and licenses, etc., trend information,
off-balance sheet arrangements and contractual obligations is disclosed under
Item 5 of the 2008 Annual Report and in our unaudited condensed consolidated
interim financial information as at and for the six months ended June 30, 2009
on Form 6-K filed with the Commission on December 14, 2009, each of which is
incorporated by reference herein.
DIRECTORS,
SENIOR MANAGEMENT AND EMPLOYEES
Directors
and Senior Management
The
following table sets forth certain information regarding our officers and
directors as of January 26, 2010. A summary of the background and
experience of each of these individuals follows the table.
<R>
|
Name
|
Age
|
Position
|
|
Joseph
Zakrzewski
|
47
|
Executive
Chairman
|
|
Thomas
Lynch
|
52
|
Non-Executive
Director
|
|
Dr.
Joseph Anderson
|
50
|
Non-Executive
Director
|
|
Dr.
Lars Ekman
|
59
|
Non-Executive
Director
|
|
Dr.
Carl L. Gordon
|
44
|
Non-Executive
Director
|
|
Dr.
James I. Healy
|
44
|
Non-Executive
Director
|
|
Dr.
Manus Rogan
|
42
|
Non-Executive
Director
|
|
Dr.
Declan Doogan
|
56
|
Interim
Chief Executive Officer
|
|
John
F. Thero
|
49
|
Chief
Financial Officer
|
|
Tom
Maher
|
43
|
Interim
General Counsel and Company Secretary
|
|
Dr.
Paresh Soni
|
49
|
Senior
Vice President and Head of Development
|
|
Conor
Dalton
|
44
|
Vice
President, Finance & Principal Accounting
Officer
|
Mr. Joe
Zakrzewski joined Amarin as a special advisor to the Board on September 15,
2009. On January 1, 2010 Mr. Zakrzewski joined the Board as Executive Chairman.
He is currently the President, Chief Executive Officer, Chairman and a Director
of Xcellerex, a privately held company focusing on commercializing its
proprietary next generation manufacturing technology for biotherapeutics and
vaccines. Mr. Zakrzewski recently served as the Chief Operating Officer of
Reliant Pharmaceuticals, a specialty pharmaceutical company focused on
cardiovascular drugs from 2005 through the first half of 2007. From 1988 to
2004, Mr. Zakrzewski served in a variety of executive level capacities at Eli
Lilly & Company including R&D, manufacturing, finance and business
development. His most recent position was Vice President, Corporate Business
Development, where he had global responsibility for all business development
activities on a global basis. Mr. Zakrzewski received a BS in Chemical
Engineering in 1986, an MS in Biochemical Engineering from Drexel University in
1988, and received an MBA in Finance in 1992 from Indiana University. In
addition to his role on the Xcellerex Board of Directors, Mr. Zakrzewski also
serves on the Boards of Insulet Corporation and Rapid Micro, is Chairman of the
Boards of Directors of Amarin Corp, Promedior Inc, and Zelos
Therapeutics.
Mr.
Thomas Lynch joined Amarin in January 2000 as Chairman of the
Board. Between 1993 and 2004, Mr. Lynch was with Elan
Corporation plc where he held a number of positions including Chief Financial
Officer and Executive Vice Chairman. Mr. Lynch spear-headed
Elan’s transition from a drug delivery technology provider to a fully integrated
pharmaceutical company, through a number of acquisitions, including Athena
Neurosciences, Inc. The Athena acquisition brought Elan its programs
in multiple sclerosis, autoimmune diseases and Alzheimer’s
disease. Mr. Lynch was also a founder of the specialty
pharmaceutical company, Warner Chilcott plc. Mr. Lynch is and
has been a board member of a number of biotechnology and healthcare
companies. Mr. Lynch resigned as Chairman on January 1, 2010 but
continues to serve as a non-executive director.
</R>
-22-
Dr.
Joseph Anderson joined Amarin as a Non-Executive Director in October
2009. Dr. Anderson is a Partner at Abingworth LLP, an international
investment group dedicated to the life sciences and healthcare
sectors. He leads private investments in public companies in the U.S.
and Europe and manages open-market portfolios of small-cap public
equities. He has more than 20 years experience as a Fund Manager and
Analyst in the pharmaceutical and bioscience sectors. Dr. Anderson
was previously at First State Investments in London, part of the Commonwealth
Bank of Australia, where he was Head of Global Healthcare Equities and Portfolio
Manager. Prior to this, he was Pharmaceuticals Analyst at investment
bank, Dresdner Kleinwort Benson. From 1990–98, Dr. Anderson
established and was Head of the Strategy Unit at the Wellcome Trust, one of the
world’s largest medical foundations. Dr. Anderson is currently a
Director of Algeta ASA, a publicly quoted oncology company developing
radiopharmaceuticals and a Director of Abingworth BioEquities, an offshore
investment fund. He has a PhD in Biochemistry.
Dr. Lars
Ekman joined Amarin as a non-executive director in November 2008. He
has more than 24 years experience in the pharmaceutical industry. He
was formerly Executive Vice President and President of Global Research and
Development at Elan Corporation plc, where he is currently a director and chairs
the Science and Technology Committee. Prior to joining Elan, he was
Executive Vice President, Research and Development at Schwarz Pharma AG and was
employed in a variety of senior scientific and clinical functions at Pharmacia,
now Pfizer. Dr. Ekman also sits on the Board of Directors of
ARYx Therapeutics Inc., InterMune Inc., and Cebix. Dr. Ekman is
a board certified surgeon with a Ph.D in experimental biology and has held
several clinical and academic positions in both the United States and
Europe. He obtained his Ph.D and M.D. from the University of
Gothenburg, Sweden.
Carl L.
Gordon, Ph. D., CFA, joined Amarin as a non-executive director in May
2008. Dr. Gordon is a founding General Partner and Co-Head of
Private Equity of OrbiMed Advisors LLC. Dr. Gordon is active in
both private equity and small-capitalization public equity
investments. He was a senior biotechnology analyst at Mehta and Isaly
from 1995 to 1997. He was a Fellow at The Rockefeller University from
1993 to 1995. Dr. Gordon received a Ph.D. in Molecular Biology
from the Massachusetts Institute of Technology. His doctoral work
involved studies of protein folding and assembly. He received a
Bachelor’s degree from Harvard College.
James I.
Healy, M.D., Ph.D., joined Amarin as a non-executive director in May
2008. Dr. Healy joined Sofinnova Ventures as a General Partner
in 2000. Dr. Healy was a founding investor and board member of
Cellective (acquired by MedImmune), CoTherix (acquired by Actelion), Novacea,
and Intermune. He also serves on the boards of directors of several
private companies. In the pharmaceutical industry Dr. Healy held
positions at Bayer Pharmaceuticals (Miles) and ISTA Pharmaceuticals prior to its
initial public offering. He began his private equity career at
Sanderling Ventures. Dr. Healy earned B.A.s in Molecular Biology and
Scandinavian Studies from the University of California at Berkeley, where he
graduated with Distinction in General Scholarship, Honors, and received a
Departmental Citation. He received his M.D. from Stanford
University’s School of Medicine through the Medical Scientist Training Program,
and earned his Ph.D. in Immunology from Stanford University, where he was a
Beckman Scholar and received a bursary award from the Novartis
Foundation. Dr. Healy teaches a course on entrepreneurship at
Stanford University, and is an active member of the BIO-NVCA Working
Group.
Dr. Manus
Rogan joined Amarin as a Non-Executive Director in October 2009. Dr. Rogan is a
Co-founder and Managing Partner at Fountain Healthcare Partners. He
began his career in product development at GlaxoSmithkline in the
UK. He completed an MBA at Trinity College Dublin in 1996 and joined
Elan Corporation’s business development group shortly thereafter. For
four years he was responsible for licensing Elan’s products and drug delivery
technologies in Europe and Japan. In 2001, Dr. Rogan joined Elan’s
corporate VC group in the U.S. where he was involved in the sourcing, screening
and management of investments in private and public biotechnology
companies. In his seven years at Elan, Dr. Rogan concluded over
twenty five investment and technology licensing transactions involving companies
in the U.S., Europe and Japan. He has a PhD in chemistry.
Dr. Declan
Doogan joined us on April 10, 2007 as Head, Research and
Development. Prior to joining us, Dr. Doogan was Senior Vice
President and Head of Worldwide Development at Pfizer Global Research &
Devel-
-23-
opment. In
recent years, he held a number of senior positions in Pfizer in the US and the
UK. Dr. Doogan joined Pfizer in 1982, where he led the Zoloft
clinical development program. He held positions in the UK and in
Japan, where he was initially Medical Director and later head of the company’s
development organization. Dr. Doogan holds Visiting
Professorships at Harvard, Glasgow and Kitasato University in
Japan. In addition, Dr. Doogan holds a number of non-executive
directorships in the US and the U.K. Dr. Doogan received his
medical degree from Glasgow University in 1975. He is a Fellow of the
Royal College of Physicians of Glasgow and the Faculty of Pharmaceutical
Medicine in the U.K.
Mr. John Thero
joined Amarin in November 2009 as Chief Financial
Officer. Mr. Thero has more than 20 years of senior financial
and operational management experience including over 15 years supporting the
growth of life science companies. Previously, Mr. Thero was
Chief Financial Officer at ViaCell, Inc., where he helped guide the company to
its successful sale, and Abiomed, Inc., during its transition from a
development-stage company into a commercial entity. Mr. Thero
began his professional career at Arthur Andersen LLP, during which time he
became a Certified Public Accountant.
<R>
Mr. Tom
Maher was appointed General Counsel and Company Secretary in February 2006,
having commenced working with the Group on a part-time basis in July
2005. Mr. Maher was previously a partner at Matheson Ormsby
Prentice Solicitors, Dublin. Prior to Matheson Ormsby Prentice,
Mr. Maher worked at Elan Corporation plc where he held the position of Vice
President of Legal Affairs. Mr. Maher commenced his legal career
at A&L Goodbody Solicitors, Dublin. He holds a law degree from
Trinity College Dublin and is an Irish qualified solicitor. On
December 10, 2009, Amarin entered into a Compromise Agreement with Tom Maher
pursuant to which Mr. Maher's employment by the Company will terminate on
January 29, 2010. Unitl such time, Mr. Maher's title will be Interim
General Counsel and Company Secretary.
Dr.
Paresh Soni joined Amarin in September 2008 as Senior VP and Head of
Development. Dr. Soni joined Amarin from Pfizer where he held a number of
leadership roles in Pfizer Global Research and Development in both experimental
medicine and late stage development. Dr. Soni, a board-certified internist and
gastroenterologist, completed his medical and specialist training at the
University of Natal in South Africa before completing a research fellowship at
the Division of Hepatology, Royal Free Hospital School of Medicine, London,
where he also completed a PhD. Dr. Soni is a member of the American
Gastroenterology Association (AGA) and American Association for the Study of
Liver Diseases (AASLD). At Amarin, he has responsibility for clinical and
non-clinical development functions.
</R>
Mr. Conor
Dalton was appointed Vice-President, Finance in May 2005. Prior to
joining Amarin, Mr. Dalton spent approximately eight years with Elan
Corporation, most recently as Director of Finance. Mr. Dalton is
a fellow of the Association of Chartered Certified Accountants.
There is
no family relationship between any director or executive officer and any other
director or executive officer.
Compensation
<R>
Directors
who are not employees receive £25,000 ($46,000) per annum for service on the
board of directors save for the Chairman of the Board, who receives £40,000
($74,000), Chairman of the audit committee who receives £40,000 ($74,000),
Chairman of the remuneration committee, who receives £40,000 ($74,000) and Lead
Independent Director who receives an additional £20,000 ($37,000) and such
options to acquire Ordinary Shares for their service as non-executive members of
the board of directors as the remuneration committee of the board of directors
may from time to time determine.
For the
year ended December 31, 2009, all of our directors and senior management as
a group received total compensation of $2,287,000 and in addition, directors and
senior management were issued options to purchase a total of 4,150,000 Ordinary
Shares during such period. See “— Share Ownership” below for the
specific terms of the options held by each director and officer.
</R>
-24-
With the
exception of Mr. Lynch, Mr. Cooke and Dr. Doogan, there are no
sums set aside or accrued by us for pension, retirement or similar benefits for
directors. We do make contributions to certain of our employees’ and
officers’ pensions during the term of their employment with us.
<R>
Compensation
payable and benefits granted to our directors during the year ended
December 31, 2009 are detailed below:
</R>
Directors’
detailed emoluments
<R>
|
Name
|
Salary/fees
$000
|
Bonus
$000
|
Benefits in kind
$000
|
Pension contributions
$000
|
Total
$000
|
|
T G
Lynch-Consulting(1)
|
418
|
—
|
14
|
49
|
481
|
|
T G
Lynch-Directors Fees
|
63
|
63
|
|||
|
A
Russell-Roberts(3)
|
63
|
—
|
—
|
—
|
63
|
|
John
Climax(3)
|
39
|
—
|
—
|
—
|
39
|
|
B.
Mason(3)
|
102
|
—
|
—
|
—
|
102
|
|
James
Healy
|
39
|
39
|
|||
|
Carl
Gordon
|
39
|
39
|
|||
|
Lars
Ekman
|
39
|
39
|
|||
|
Joseph
Anderson(2)
|
8
|
8
|
|||
|
Manus
Rogan(2)
|
8
|
8
|
|||
|
818
|
14
|
49
|
881
|
||
|
Senior
Management
|
1,406
|
||||
|
Total
emoluments incl. Senior Management
|
2,287
|
||||
|
|
Benefits
in kind include medical and life
insurance.
|
|
(1)
|
Fees
in respect of a Consultancy Agreement with Mr. Lynch. See “Item
7B—Related Party Transactions” of the 2008 Annual
Report.
|
|
(2)
|
Appointed
directors on October 19, 2009.
|
|
(3)
|
Resigned
as directors on October 19, 2009.
|
</R>
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.
<R>
The plan
is administered by the remuneration committee of our board of
directors. A maximum of 800,000 Ordinary Shares may be issued under
the plan. This limit was increased to 898,643 Ordinary Shares by the
remuneration committee of the Group on December 6, 2006, pursuant to section
4(c) of the Plan to prevent dilution of the potential benefits available under
the Plan as a result of certain discounted share issues. This limit
was further increased to 1,200,000 Ordinary Shares at an Extraordinary General
Meeting held on January 25, 2007. This limit was further increased to
1,800,000 Ordinary Shares at an Annual General Meeting held on July 19,
2007. This limit was further increased to 4,000,000 Ordinary Shares
at an Annual General Meeting held on July 31, 2008. This limit was
further increased to 10,000,000 at an Annual General Meeting held on December
21, 2009. Directors, employees, officers, consultants and independent
contractors are eligible persons under the plan. The remuneration
committee may grant options to eligible persons. In determining which
eligible persons may receive an award of options
-25-
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.
</R>
Two forms
of options may be granted under the plan: incentive stock options and
non-qualified stock options. Incentive stock options are options
intended to meet the requirements of Section 422 of the U.S. Internal Revenue
Code of 1986, as amended. Non-qualified stock options are options
which are not intended to be incentive stock options.
As a
condition to the grant of an option award, we and the recipient shall execute an
award agreement containing such restrictions, terms and conditions, if any, as
the remuneration committee may require. Option awards are to be
granted under the plan for no cash consideration or for such minimal cash
consideration as may be required by law. The exercise price of
options granted under the plan shall be determined by the remuneration
committee; however the plan provides that the exercise price shall not be less
than 100% of the fair market value, as defined under the plan, of an Ordinary
Share on the date that the option is granted. The consideration to be
paid for the shares under option shall be paid at the time that the shares are
issued. The term of each option shall end ten years following the
date on which it was granted. The remuneration committee may decide
from time to time whether options granted under the plan may be exercised in
whole or in part.
No option
granted under the plan may be exercised until it has vested. The
remuneration committee will specify the vesting schedule for each option when it
is granted. Up to January 30, 2009, if no vesting schedule was
specified with respect to a particular option, then the vesting schedule set out
in the plan applied so that 33% of the total number of Ordinary Shares granted
under the option vested on the first anniversary of the date that the option was
granted, a further 33% vested on the second anniversary and the remaining 34%
vested on the third anniversary.
On
January 30, 2009 the plan was amended so that 25% of the total number of
Ordinary Shares granted under an option shall vest on the first anniversary of
the date that the option was granted, a further 25% shall vest on the second,
third and fourth anniversaries. This amendment applies to all option
grants after February 1, 2009.
If a
participant’s continuous status as an employee or consultant, as defined under
the plan, is terminated for cause then his or her options shall expire
immediately. If such status is terminated due to death or permanent
disability and if options held by the participant have vested and are
exercisable, they shall remain exercisable for twelve months following the date
of the participant’s death or disability. If such status is terminated for any
reason other than for cause, death or permanent disability and if options held
by the participant have vested and are exercisable, they shall remain
exercisable for twelve months following the date of the participant's
termination.
No option
award, nor any right under an option award, may be transferred by a participant
other than by will or by the laws of descent as specifically set out in the
plan. Participants do not have any rights as a shareholder of record
in us with respect to the Ordinary Shares issuable on the exercise of their
options until a certificate representing such Ordinary Shares registered in the
participant’s name has been delivered to the participant.
The plan
is governed by the laws of England.
Board
Practices
No
director has a service contract providing for benefits upon the termination of
service or employment.
<R>
Our
articles of association stipulate that the minimum number of directors shall be
two and the maximum number shall be fifteen. At December 31, 2009 we
had six 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-
-26-
election
and second, we choose the directors who have served as directors for the longest
period of time since their last election.
</R>
On May
16, 2008, Drs. Doogan, Kukes, Walsh and Lachman, Prof. Hall and Messrs. Cooke
and Groom resigned from the board of directors. On the same date Drs.
James I. Healy, Carl Gordon, Eric Aguiar and Srinivas Akkaraju were appointed to
the board. On November 3, 2008 Dr. Lars Ekman was appointed to the
board. On June 1 and May 15, 2009, Drs. Aguiar and Akkaraju
resigned from the board of directors respectively. On
October 16, 2009, Mr. Anthony Russell-Roberts and Drs. John Climax and
William Mason resigned from the board of directors. On October 16,
2009, Drs. Joseph Anderson and Manus Rogan were appointed to the
board.
<R>
At the
annual general meeting in 2008, Drs. James I. Healy, Srinivas Akkaraju, Eric
Aguiar and Carl Gordon stood for election and Drs. Climax and Mason retired
by rotation. Each director was re-elected. Mr. Lynch
and Drs. Healy, Anderson, Rogan and Ekman retired and stood for re-election
at the annual general meeting in 2009. Each director was
re-elected. See — “Directors and Senior Management” above for details
of when each of our directors joined our board of directors.
</R>
Audit
Committee
The audit
committee of the board of directors generally comprises at least three of our
non-executive directors and meets, as required, to review the scope of the audit
and audit procedures, the format and content of the audited financial statements
and the accounting principles applied in preparing the financial
statements. The audit committee also reviews proposed changes in
accounting policies, recommendations from the auditors regarding improving
internal controls and the adequacy of resources within the accounting
function.
<R>
As of
January 26, 2010, the audit committee comprised the following
directors:
</R>
|
·
|
Dr. Lars
Ekman (appointed November 2, 2009);
and
|
|
·
|
Dr. Manus
Rogan (appointed November 2,
2009).
|
The
Company has notified Nasdaq that it is availing itself of the limited exemption
provided under Nasdaq Rule 5605(c)(4)(B) permitting the audit committee to have
two members. The Company is fully committed to appointing the third
qualified independent director to serve on the audit committee as soon as
practicable.
Remuneration
Committee
The
remuneration committee of the board of directors comprises at least three of our
non-executive directors. The remuneration committee’s primary
responsibility is to approve the level of remuneration for executive directors
and key employees. It may also grant options under our share option
schemes and must approve any service contracts for executive directors and key
employees. Non-executive directors’ remuneration is determined by the
full board of directors.
As of
January 26, 2010, the remuneration committee comprised the following
directors:
|
·
|
Dr. James I.
Healy (appointed May 27,
2008);
|
|
·
|
Dr. Manus
Rogan (appointed November 2, 2009);
and
|
|
·
|
Dr. Joseph
Anderson (appointed November 2,
2009).
|
Nominations
Committee
<R>
As of
January 26, 2010, the nominations committee comprised the following
directors:
</R>
-27-
|
·
|
Dr. James I.
Healy (appointed May 27, 2008);
|
|
·
|
Dr. Carl
Gordon (appointed May 27, 2008);
and
|
|
·
|
Dr. Joseph
Anderson (appointed November 2,
2009).
|
Lead
Independent Director
None.
Employees
Information
regarding the Company’s employees is disclosed under Item 6.D of the 2008 Annual
Report, which is incorporated by reference herein.
Share
Ownership
<R>
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 January 26, 2010 are presented in the table below. See also
“— Compensation — the Amarin Corporation plc 2002 Stock Option and the Amarin
Long Term Incentive Plan”.
|
Director/Officer
|
Note
|
Options/Warrants
Outstanding
to
Acquire
Number
of
Ordinary
Shares
|
Date
of Grant
(dd/mm/yy)
|
Exercise
Price
per
Ordinary
Share
|
Ordinary
Shares
or ADS
Equivalents
Beneficially
Owned
|
Percentage
of
Outstanding
Share
Capital(a)
|
|
J.
Anderson
|
1
& 9
|
8,500,000
|
16/10/09
|
$1.50
|
17,000,000
|
17.2%
|
|
J.
Healy
|
2
& 9
|
3,500,000
|
16/10/09
|
$1.50
|
10,586,958
|
10.7%
|
|
C.
Gordon
|
3
& 9
|
3,500,000
|
16/10/09
|
$1.50
|
10,260,872
|
10.4%
|
|
M.
Rogan
|
4
& 9
|
2,500,000
|
16/10/09
|
$1.50
|
5,217,391
|
5.3%
|
|
T.G.
Lynch
|
5
|
20,792
|
21/12/05
|
$14.30
|
1,350,683
|
1.4%
|
|
6
|
1,248
|
01/06/07
|
$7.20
|
|||
|
7
|
30,303
|
06/12/07
|
$1.17
|
|||
|
8
|
138,888
|
31/07/09
|
$1.00
|
|||
|
9
|
138,888
|
16/10/09
|
$1.50
|
|||
|
10
|
500,000
|
16/10/09
|
$1.50
|
|||
|
W.
Mason
|
12
|
1,500
|
06/11/02
|
$31.00
|
—
|
—
|
|
12&16
|
2,500
|
21/07/04
|
$8.40
|
|||
|
12&16
|
2,000
|
11/01/06
|
$13.50
|
|||
|
12&13
|
2,000
|
08/12/06
|
$4.40
|
|||
|
20
|
40,000
|
16/10/09
|
$1.64
|
|||
|
A.
Russell-Roberts
|
12
|
1,000
|
07/04/00
|
$30.00
|
235
|
—
|
|
12
|
1,000
|
19/02/01
|
$61.20
|
|||
|
12
|
1,500
|
23/01/02
|
$176.50
|
|||
|
12
|
1,500
|
06/11/02
|
$31.00
|
|||
|
12
|
2,500
|
21/07/04
|
$8.40
|
|||
|
12
|
2,000
|
11/01/06
|
$13.50
|
|||
|
12&13
|
2,000
|
08/12/06
|
$4.40
|
|||
|
20
|
50,000
|
16/10/09
|
$1.64
|
|||
|
J.
Climax
|
7
|
22,698
|
21/12/05
|
$14.30
|
3,687,977
|
3.7%
|
|
12
|
2,000
|
27/01/06
|
$27.20
|
|||
|
12
|
2,000
|
20/03/06
|
$32.60
|
|||
|
12&13
|
2,000
|
08/12/06
|
$4.40
|
|||
|
17
|
3,327
|
01/06/07
|
$7.20
|
|||
|
18
|
136,363
|
06/12/07
|
$2.99
|
|||
|
20
|
20,000
|
16/10/09
|
$1.64
|
-28-
|
J.
Zakrzewski
|
11
|
1,170,000
|
21/12/09
|
$1.35
|
—
|
—
|
|
A.
Cooke
|
19
|
37,500
|
07/07/04
|
$8.50
|
27,021
|
—
|
|
19
|
20,000
|
10/06/05
|
$13.00
|
|||
|
5
|
1,559
|
21/12/05
|
$14.30
|
|||
|
19
|
20,000
|
16/01/06
|
$19.50
|
|||
|
19&13
|
67,500
|
08/12/06
|
$4.40
|
|||
|
19
|
400,000
|
20/05/08
|
$2.60
|
—
|
—
|
|
|
10
|
247,050
|
16/10/09
|
$1.50
|
|||
|
J.
Thero
|
12
|
900,000
|
21/12/09
|
$1.35
|
—
|
—
|
|
D.
Doogan
|
12
|
65,000
|
09/04/07
|
$4.40
|
—
|
—
|
|
12
|
400,000
|
20/05/08
|
$2.60
|
—
|
—
|
|
|
11
|
1,170,000
|
21/12/09
|
$1.35
|
—
|
—
|
|
|
T.
Maher
|
12
|
32,500
|
02/12/05
|
$11.60
|
1,980
|
—
|
|
14
|
693
|
21/12/05
|
$14.30
|
|||
|
12&13
|
35,000
|
08/12/06
|
$4.40
|
|||
|
12
|
15,000
|
02/08/07
|
$4.40
|
|||
|
12
|
15,000
|
28/08/07
|
$4.60
|
|||
|
12
|
280,000
|
20/05/08
|
$2.60
|
—
|
—
|
|
|
10
|
156,955
|
10/12/09
|
$1.50
|
|||
|
C.
Dalton
|
12
|
10,000
|
28/06/05
|
$10.90
|
—
|
—
|
|
12
|
5,000
|
12/01/06
|
$15.30
|
—
|
—
|
|
|
12&13
|
20,000
|
08/12/06
|
$4.40
|
—
|
—
|
|
|
12
|
50,000
|
20/05/08
|
$2.60
|
—
|
—
|
|
|
P.
Soni
|
12
|
100,000
|
01/09/08
|
$1.43
|
—
|
—
|
|
11
|
800,000
|
21/12/09
|
$1.35
|
</R>
Notes:
|
(1)
|
These
shares and warrants have been issued to Abingworth Bioventures V L.P.,
Abingworth Bioventures V Co-Invest Growth Equity Fund LP and Abingworth
Bioequities Master Fund Limited, the management company of which Dr.
Joseph Anderson is a Partner. Dr. Joseph Anderson is also a
non-executive director of Amarin.
|
|
(2)
|
These
shares and warrants have been issued to Sofinnova Venture Partners VII,
L.P., the management company of which Dr. James I. Healy is a Managing
General Partner. Dr. James I. Healy is also a non-executive director
of Amarin.
|
|
(3)
|
These
shares and warrants have been issued to Caduceus Private Investments III,
LP and OrbiMed Associates III, LP, of whom Dr. Carl L. Gordon is a General
Partner. Dr. Carl L. Gordon is also a non-executive director of
Amarin.
|
|
(4)
|
These
shares and warrants have been issued to Fountain Healthcare Partners Fund,
of whom Dr. Manus Rogan is a Managing Partner. Dr. Manus Rogan
is also a non-executive director of
Amarin.
|
|
(5)
|
These
warrants were issued 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. If our trading market price is equal to or
above $102, as adjusted for any stock splits, stock combinations, stock
dividends and other similar events, for each of any twenty consecutive
trading days, then the Group at any time thereafter shall have the right,
but not the obligation, on 20 days’ prior written notice to the holder, to
cancel any unexercised portion of this warrant for which a notice of
exercise has not yet been delivered prior to the cancellation
date.
|
|
(6)
|
These
warrants were issued to all investors in the June 2007 registered direct
offering including directors and are exercisable immediately from the
grant date. The warrants were issued to Amarin Investment
Holding Limited which is an entity controlled by our Chairman, Mr. Thomas
Lynch.
|
-29-
|
(7)
|
These
warrants were issued to all investors in the December 2007 registered
direct offering including directors and are exercisable immediately from
the grant date. The warrants were issued to Amarin Investment
Holding Limited which is an entity controlled by our Chairman, Mr. Thomas
Lynch. There is a price adjustment clause in the December 2007
warrant agreement which provides that if, at any time prior to December 6,
2009, the Company issues Ordinary Shares, securities convertible into ADSs
or Ordinary Shares, warrants to purchase ADSs or Ordinary Shares, or
options to purchase any of the foregoing to a third party (other than any
Exempt Issuance) at a price that is less than, or converts at a price that
is less than $3.66 (such lesser price, the “Down-round Price”), then the
Exercise Price shall be adjusted to equal 130% of the Down round
Price. On May 16, 2008, Amarin raised gross proceeds of
$30,000,000 in a private placement of equity at a share price of $2.30 per
Ordinary Share. As $2.30 is below the Down-round Price, the
initial warrant exercise price has been adjusted from $4.80 to
$2.99. On October 16, 2009, $3.6 million convertible bridge
notes converted at $0.90 per share. These warrants have
therefore been re-priced again, to $1.17 per
share.
|
|
(8)
|
These
warrants were issued to all investors in the June 2009 convertible bridge
loan including directors and are exercisable immediately from the grant
date.
|
|
(9)
|
These
warrants were issued to all investors who participated in the October 2009
private placement of equity including directors and are exercisable
immediately from the grant date.
|
|
(10)
|
These
warrants were issued during the fourth quarter of 2009 and are exercisable
immediately from the date of
issuance.
|
|
(11)
|
These
options are exercisable as to one quarter on each of the first, second,
third and fourth anniversaries of the date of grant and remain exercisable
for a period ended on the tenth anniversary of the date of
grant.
|
|
(12)
|
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.
|
|
(13)
|
The
exercise price of all options granted between December 8, 2006 and April
11, 2007 were amended to $4.40.
|
|
(14)
|
These
warrants were issued to all investors in the December 2005 private
placement including directors and are exercisable at anytime after 180
days from the grant date. If our trading market price is equal
to or above $102, as adjusted for any stock splits, stock combinations,
stock dividends and other similar events, for each of any twenty
consecutive trading days, then the Group at any time thereafter shall have
the right, but not the obligation, on 20 days’ prior written notice to the
holder, to cancel any unexercised portion of this warrant for which a
notice of exercise has not yet been delivered prior to the cancellation
date.
|
|
(15)
|
These
options are exercisable immediately from the date of grant and remain
exercisable for a period ended on the tenth anniversary of the date of
grant.
|
|
(16)
|
These
options were issued to Vision Resources Limited, a company wholly owned by
Dr. Mason.
|
|
(17)
|
These
warrants were issued to all investors in the June 2007 registered direct
offering including directors and are exercisable immediately from the
grant date. These warrants were issued to Sunninghill Limited which is an
entity controlled by one of our non-executive directors Dr. John
Climax
|
|
(18)
|
These
warrants were issued to all investors in the December 2007 registered
direct offering including directors and are exercisable immediately from
the grant date. These warrants were issued to Sunninghill Limited which is
an entity controlled by one of our non-executive directors Dr. John
Climax. There is a price adjustment clause in the December 2007 warrant
agreement which provides that if, at any time prior to
De-
|
-30-
cember 6,
2009, the Company issues Ordinary Shares, securities convertible into ADSs or
Ordinary Shares, warrants to purchase ADSs or Ordinary Shares, or options to
purchase any of the foregoing to a third party (other than any Exempt Issuance)
at a price that is less than, or converts at a price that is less than $3.66
(such lesser price, the “Down-round Price”), then the Exercise Price shall be
adjusted to equal 130% of the Down round Price. On May 16, 2008, Amarin raised
gross proceeds of $30,000,000 in the first tranche of a private placement of
equity at a share price of $2.30 per Ordinary Share. As $2.30 is below the
Down-round Price, the initial warrant exercise price has been adjusted from
$4.80 to $2.99. In connection with the 2009 Private Placement, $3.6 million
convertible bridge notes converted at $0.90 per share. These warrants have
therefore been re-priced again, to $1.17 per share.
|
(19)
|
These
options are fully vested and exercisable until October 31,
2010.
|
|
(20)
|
These
options are fully exercisable from October 16, 2009 and expire on June 30,
2011.
|
<R>
|
(a)
|
This
information is based on 98,801,982 Ordinary Shares outstanding as of
January 26, 2010.
|
</R>
MAJOR
SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
Major
Shareholders
Information
regarding the Company’s major shareholders is disclosed under Item 7.A of the
2008 Annual Report, which is incorporated by reference herein.
Related
Party Transactions
Information
regarding the Company’s related party transactions is disclosed under Item 7.B
of the 2008 Annual Report, which is incorporated by reference
herein.
Interests
of Experts and Counsel
None.
FINANCIAL
INFORMATION
Consolidated
Statements and Other Financial Information
Our
consolidated financial statements and other financial information on pages F-1
to F-69 of our Annual Report on Form 20-F for the year ended December 31, 2008
are incorporated by reference herein.
Our
unaudited interim financial statements and other financial information for the
six months ended June 30, 2009 on Form 6-K filed with the Commission on December
14, 2009 are incorporated by reference herein.
Significant
Changes
October
2009 Private Placement
On
October 13, 2009, Amarin announced it had entered into definitive agreements
with several existing and new institutional and accredited investors for a
private placement of units for $70 million, consisting of $66.4 million in cash
proceeds and $3.6 million from the conversion of convertible bridge
notes. On the closing of the 2009 Private Placement, in consideration
for the $66.4 million received in cash, Amarin issued 66.4 million
units. Each unit had a purchase price of $1.00 and consisted of one
American Depositary Share (“ADS”) and a warrant to purchase 0.50 of an
ADS. The warrants have a five year term and an exercise price of
$1.50 per ADS. In consideration for the conversion of $3.6 million of
convertible bridge notes, Amarin issued 4.0 million units. In
accordance with the terms of the conversion of the bridge notes, each unit had a
purchase price of $0.90 and consisted of one ADS
-31-
and a
warrant to purchase 0.50 of an ADS. The warrants also have a five
year term and an exercise price of $1.50 per ADS.
Repayment
and Conversion of Debt and Warrant Issuance
On July
31, 2009, the Company issued warrants to purchase 3,111,105 shares with an
exercise price of $1.00. These warrants were issued to the holders of
the convertible bridge loan notes in consideration for their participation in
the Bridge Financing. They are in addition to the warrants that were
issued on conversion of the convertible bridge loan notes described
above.
On
October 16, 2009, in connection with the 2009 Private Placement, the holders of
$3.6 million convertible bridge loan notes converted their principal into units
and the accrued interest was repaid in cash and the holders of the remaining
$1.9 million in convertible bridge loan notes elected to have their principal
and accrued interest repaid in cash.
The
convertible bridge loan notes had been issued in June and August
2009. In May 2009, Amarin announced that it entered into definitive
agreements for a private placement of convertible bridge loan notes (“Initial
Bridge Financing”) in the amount of $2.6 million with certain existing investors
in the Company, including a number of current directors of the
Company. In July 2009, $0.1 million of the Bridge Financing was
repaid. In August 2009, the date of maturity on the convertible loans
was extended to September 30, 2009. In August 2009, Amarin announced
that it had entered into definitive agreements for a private placement of
additional convertible bridge loan notes (“Additional Bridge Financing”) in the
amount of $3.0 million with certain existing investors in the Company, including
a number of current directors of the Company. The Initial Bridge
Financing and Additional Bridge Financing consisted of convertible notes and
warrants. The aggregate convertible notes were in the principal
amount of $5.5 million, were to mature on September 30, 2009 and were to pay
interest at the rate of 8% per annum. In September 2009, the date of
maturity was extended to October 16, 2009.
Cancellation
of 2008 Financing Option and Conversion of Preference Shares
Coincident
with the consummation of the 2009 Private Placement, the funding option
associated with the second tranche of the May 2008 Financing and the preemptive,
registration and board seat rights provided by the Securities Purchase
Agreement, dated May 13, 2008, entered into in connection with the May 2008
Financing, were cancelled and the eight preference shares granted to certain of
the 2008 investors were converted into eight Ordinary Shares in
Amarin.
Re-pricing
of Previously Issued Warrants
During
December 2007, in a registered direct offering, 1,043,704 warrants were issued
to the participants in the offering. The warrants were issued at an
exercise price of $4.80 and are exercisable from December 4, 2007 to December 3,
2012. Pursuant to the warrant agreement, if at any time prior to
December 6, 2009, the Company issues Ordinary Shares, securities convertible
into ADSs or Ordinary Shares, warrants to purchase ADSs or Ordinary Shares or
options to purchase any of the foregoing to a third party (other than any Exempt
Issuance) at a price that is less than, or converts at a price that is less
than, $3.66 (such lesser price, the “Down-round Price”), then the Exercise Price
shall be adjusted to equal 130% of the Down-round Price. On May 14,
2008, we announced a private placement of Ordinary Shares for $30.0 million at
$2.30 per share. The exercise price of the warrants was therefore
adjusted to $2.99 per share from their original exercise price of $4.80 per
share. On October 16, 2009, $3.6 million of convertible bridge loan
notes converted at $0.90 per share. The exercise price of the
warrants was therefore adjusted again to $1.17 per share.
Changes
in Directors, Officers and Board Committees
On May
15, 2009, Dr. Srinivas Akkaraju resigned from his position as a non-executive
director. Dr. Akkaraju recently joined New Leaf Venture
Partners. Dr. Akkaraju was previously at Panorama Capital, an
investor in the May 2008 Financing.
-32-
On June
1, 2009, Dr. Eric Aguiar resigned from his position as a non-executive
director. Dr. Aguiar is currently a partner at Thomas, McNerney &
Partners LP, an investor in the May 2008 Financing.
Since the
closing of the 2009 Private Placement, Mr. Alan Cooke, President, Chief
Operating Officer and Chief Financial Officer, has stepped down from his
position and has been be replaced by John F. Thero as Chief Financial
Officer.
<R>
Since the
closing of the 2009 Private Placement, Mr. Thomas Lynch, Chairman and previously
Chief Executive Officer of Amarin, has stepped down as Chief Executive Officer
and Chairman. Dr. Declan Doogan, Head of Research and Development,
has assumed the role of Interim Chief Executive Officer. On
October 12, 2009, the Company entered into a letter agreement with Dr. Doogan
regarding his appointment as Interim Chief Executive Officer, pursuant to which
the Company agreed to grant 1,170,000 share options to him on or before January
1, 2010. These share options were granted on December 21,
2009. On January 1, 2010, Mr. Joe Zakrzewski was appointed Executive
Chairman and joined the Board.
On
October 16, 2009, as a result of the 2009 Private Placement described above,
certain investors were entitled to join Amarin’s board of
directors. On October 16, 2009, Dr. Manus Rogan of
Fountain Healthcare Partners and Dr. Joseph Anderson of Abingworth LLP joined
the board. On the same date Mr. Anthony Russell-Roberts and
Drs. John Climax and William Mason resigned from their positions as
non-executive directors.
</R>
On
October 16, 2009, Dr. William Mason and Mr. Anthony Russell-Roberts resigned
from the Company’s audit committee and remuneration committee and Dr. Carl
Gordon resigned from the Company’s remuneration committee. On
November 2, 2009, Dr. Lars Ekman and Dr. Manus Rogan were appointed to the
Company’s audit committee, Dr. James I. Healy, Dr. Manus Rogan and Dr. Joseph
Anderson were appointed to the Company’s remuneration committee and Dr. James I.
Healy, Dr. Carl Gordon and Dr. Joseph Anderson were appointed to the Company’s
nominations committee.
<R>
On
November 6, Amarin announced the appointment of John F. Thero as the Company’s
Chief Financial Officer. Pursuant to his employment agreement, Mr.
Thero will be entitled to receive compensation including a base salary of
$275,000 per annum. On December 21, 2009, the Company issued Mr. Thero employee
options to purchase 900,000 shares in Amarin at an exercise price of
$1.35. The options will vest and become exercisable in four equal
annual installments beginning in the first anniversary of the date of
grant.
On
December 2, 2009, Amarin announced that Joseph S. Zakrzewski would join the
Company’s Board of Directors as Executive Chairman effective January 1,
2010. Effective upon Mr. Zakrzewski joining the Board of Directors as
Executive Chairman on January 1, 2010, Mr. Lynch stepped down as Chairman but
will continue to serve as a member of Amarin’s Board of Directors. On
December 21, 2009, the Company issued to Mr. Zakrzewski, employee options to
purchase 1,170,000 shares in Amarin at an exercise price of $1.35. The options
will vest in four equal annual installments commencing January 1,
2010. Prior to becoming the Executive Chairman, the Company had also
agreed to pay Mr. Zakrzewski $37,500 per calendar quarter.
On
December 10, 2009, Amarin entered into a Compromise Agreement with Tom Maher
pursuant to which Mr. Maher’s employment by the Company will terminate on
January 31, 2010. Until such time, Mr. Maher’s title will be Interim
General Counsel and Company Secretary. Under the terms of the
Compromise Agreement, Mr. Maher will be entitled to receive severance of
€273,498 and all unvested options to purchase Ordinary Shares held by Mr. Maher
will become vested and such options, as well as any other vested options held by
him, will expire, unless otherwise exercised, on June 30, 2011. The
Company issued warrants, exercisable until October 16, 2014 to purchase 156,955
Ordinary Shares, to Mr. Maher on December 10, 2009.
</R>
-33-
Amendment
to Ester acquisition agreement
In August
2009, as part of the amendment and waiver agreement described below (“amendment
agreement”), Amarin issued 1,315,789 shares to the former shareholders of Ester
Neurosciences Limited (“Ester”). In June 2009, Amarin amended the
Ester acquisition agreement entered into in December 2007 (“original agreement”)
with the former shareholders of Ester. The amendment agreement, which
reflects Amarin’s intention to seek a partner for EN101, provides for the
release of Amarin from all research and development diligence obligations
contained in the original agreement, with all remaining contingent payment
obligations payable under the original agreement to be made from income received
from potential partners. If Amarin fails to secure a partnering
arrangement within a period of 21 months from the date of the amended agreement
(which period can be extended to 27/30 months) Amarin can either reassume its
research and development diligence obligations contained in the original
agreement (this option expires at the 27 month extension), or at the request of
Medica (the seller’s representative) transfer its rights in the share capital of
Ester to Medica in full for no consideration. The agreement also
extinguished in full the Company’s obligation to pay the milestone Ia
consideration.
Divestiture
of rights to Lorazepam
On July
22, 2009, Amarin announced that it had executed an agreement for the disposal of
its rights in a novel, nasal lorazepam formulation for emergency seizures to
Elan Drug Technologies for an upfront payment of $0.7 million. Amarin
had previously announced in 2008 that following the repositioning of the Group
to focus on cardiovascular disease, all of our central nervous system programs,
including nasal lorazepam, would be partnered or divested.
Medpace
engaged for contract research services
On
October 19, 2009, Amarin executed an agreement with Medpace, Inc., a leading
Contract Research Organization with expertise in conducting clinical trials in
cardiovascular and metabolic disease, to engage their services in the execution
of our phase III clinical trials with AMR101 in patients with very high
triglyceride levels (the AMR101 MARINE Study) and mixed
dyslipidemia. The phase III AMR101 MARINE Study will be a
multi-center, placebo-controlled, randomized, double-blind, 12-week study to
evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients
with fasting triglyceride levels of ≥500 mg/dL. The phase III mixed
dyslipidemia trial will be a multi-center, placebo-controlled, randomized,
double-blind, 12-week study to evaluate the efficacy and safety of 2 grams and 4
grams of AMR101 in patients with high triglyceride levels of ≥200 mg/dL and
<500 mg/dL who are on statin therapy. This trial is aimed at
potentially broadening the label for AMR101 to position it as “best-in-class” in
the prescription Omega-3 market in the U.S as well as to show its potential as
an effective combination therapy with established statin therapies.
Huntington’s
Disease
On
December 2, 2009, Amarin announced while the safety profile of AMR101 for
Huntington’s disease remains very encouraging, feedback from European regulatory
authorities indicates that additional study of AMR101 is required to establish
efficacy of this product candidate in treating the motor symptoms of
Huntington’s disease. As a result, Amarin has elected to voluntarily
withdraw its previously announced European marketing application for AMR101
relating to an Orphan Medicinal Product indication for a subset of Huntington’s
disease patients. Pursuant to this voluntary withdrawal, Amarin will
intentionally concentrate its resources on cardiovascular disease, initially
directed at regulatory approval and commercial launch of AMR101 in the United
States as quickly as possible.
Intangible
Asset Impairment
<R>
Subsequent
to the October 2009 financings and subsequent board changes, in December 2009
Amarin announced its heightened strategic and operating focus on cardiovascular
disease and its cessation of research and de-
-34-
velopment
of product candidates in the field of central nervous system disorders.
Furthermore, the Company has undertaken an effort to out-license its EN101
intangible asset. The Company now considers the value of its EN101
intangible assets to be impaired. The Company is in discussions with various
companies that have expressed an interest in acquiring rights to the EN101
intangible asset. As of
January 26, 2010, the Company has not received any acceptable offers.
Unless such expressions of interest advance into at least one binding
offer on terms which are acceptable to the Company, the Company plans a non-cash
write down of the value of this intangible asset. This write down
will occur in the second half of 2009 and is likely to represent a write down of
all, or substantially all, of the prior carrying value of this intangible
asset. This write down will increase net loss and reduce net assets
of Amarin by the amount of the impairment.
</R>
Capitalization
The
following table sets forth, on an IFRS basis, our capitalization as of December
31, 2008 on an actual basis and as adjusted to give effect to the 2009 Private
Placement as if the 2009 Private Placement occurred on December 31,
2008. This table should be read in conjunction with our consolidated
financial statements for the three years ended December 31, 2008 set forth in
our 2008 Annual Report. For a recent capitalization table of the Company dated
as of June 30, 2009, see “Key Information — Capitalization and
Indebtedness.”
As at
June 30, 2009 we held approximately $1.64 million of cash and receivables
balances.
|
Actual
$’000
|
Pro
forma
$’000
(1)
|
Pro
forma
$’000
(2)
|
||||||||||
|
Shareholders’
equity:
|
||||||||||||
|
Ordinary
Share capital
|
25,928 | 84,243 | 113,402 | |||||||||
|
Treasury
shares
|
(217 | ) | (217 | ) | (217 | ) | ||||||
|
Capital
redemption reserve
|
27,633 | 27,633 | 27,633 | |||||||||
|
Share
premium account
|
152,864 | 161,231 | 184,375 | |||||||||
|
Profit
and loss account — (deficit)
|
(220,326 | ) | (220,326 | ) | (220,326 | ) | ||||||
|
Other
reserves (share based payments, warrants, etc.)
|
28,142 | 28,142 | 28,142 | |||||||||
|
Total
shareholders’ equity
|
14,024 | 80,706 | 133,009 | |||||||||
|
Total
capitalization
|
14,024 | 80,706 | 133,009 | |||||||||
Note
to capitalization table — Non-adjusting event after reporting
period
<R>
Subsequent
to the October 2009 financings and subsequent board changes, in December 2009
Amarin announced its heightened strategic and operating focus on cardiovascular
disease and its cessation of research and development of product candidates in
the field of central nervous system disorders. Furthermore, the Company has
undertaken an effort to out-license its EN101 intangible asset. The
Company now considers the value of its EN101 intangible assets to be impaired.
The Company is in discussions with various companies that have expressed an
interest in acquiring rights to the EN101 intangible
asset. As of
January 26, 2010, the Company has not received any acceptable offers.
Unless such expressions of interest advance into at least one binding
offer on terms which are acceptable to the Company, the Company plans a non-cash
write down of the value of this intangible asset. This write down
will occur in the second half of 2009 and is likely to represent a write down of
all, or substantially all, of the prior carrying value of this intangible
asset. This write down will increase net loss and reduce net assets
of Amarin by the amount of the impairment.
</R>
|
(1)
|
On
an as-adjusted basis to give effect for the sale of shares (only) in
connection with the 2009 Private
Placement.
|
|
(2)
|
On
an as-adjusted basis to give effect for the sale of shares and 50% warrant
coverage in connection with the 2009 Private
Placement.
|
The above
table does not reflect the following:
-35-
|
·
|
On
the issuance of convertible loan notes of $5.6 million, the holders of the
convertible loan notes received Bridge Warrants, having a five year
duration and exercisable for an amount of Ordinary Shares equal to 50% of
the Ordinary Shares into which such lender’s bridge loan note was
convertible, at an exercise price equal to the per share price paid by the
investors in the 2009 Private
Placement.
|
|
·
|
In
August 2009, Amarin issued 1,315,789 Ordinary Shares with a nominal value
of $1,046,000 to the former shareholders of Ester
Neurosciences. These shares were issued as part of the
Amendment & Waiver Agreement between Amarin and the former
shareholders of Ester Neurosciences entered into in May
2009.
|
|
·
|
In
September 2009, Amarin issued 39,473 Ordinary Shares with a nominal value
of $33,000 to ProSeed Capital Holdings CVA. These shares were
issued as part of a collaboration agreement between Amarin and ProSeed
Capital Holdings CVA entered into in January
2008.
|
|
·
|
In
the period January 1, 2009 to October 12, 2009, we issued 338,500 share
options with an average exercise price of $0.99. 182,836 share
options with an average exercise price of $16.28 lapsed or were forfeited
in the same period.
|
|
·
|
At
closing of the 2009 Private Placement, the non-executive directors Dr.
John Climax, Dr. Bill Mason and Mr. Anthony Russell Roberts resigned as
directors. Such directors were each granted 5,000 stock options per year
of service which vested in full on
closing.
|
|
·
|
Since
the 2009 Private Placement, the Company has issued to certain executives
of Amarin the Executive Warrants, having substantially the same terms as
the 2009 Warrants, to purchase an aggregate amount of 904,005 Ordinary
Shares.
|
<R>
|
·
|
On
December 21, 2009, the Company issued to each of Dr. Declan Doogan and Dr.
Joseph Zakrzewski 1,170,000 share options, to Mr. John Thero 900,000 share
options and to Mr. Paresh Soni 800,000 share options, in each case at an
exercise price of $1.35.
|
|
·
|
During
December 2009, the Company issued to Tom Maher warrants, having
substantially the same terms as the 2009 Warrants, to purchase 156,955
Ordinary Shares.
|
</R>
THE
OFFER AND LISTING
Offer
and Listing Details
The
following table sets forth the range of high and low closing sale prices for our
ADSs for the periods indicated, as reported by the Nasdaq Capital
Market. These prices do not include retail mark-ups, markdowns, or
commissions but give effect to a change in the number of Ordinary Shares
represented by each ADS, implemented in January 2008. Historical data
in the table has been restated to take into account this change.
<R>
|
US$
High*
|
US$
Low*
|
|
|
Fiscal
Year Ended
|
||
|
December
31, 2005
|
34.00
|
10.60
|
|
December
31, 2006
|
37.40
|
12.70
|
|
December
31, 2007
|
37.80
|
2.30
|
|
December
31, 2008
|
3.59
|
0.60
|
|
December
31, 2009
|
0.52
|
1.95
|
-36-
|
Fiscal
Year Ended December 31, 2008
|
||
|
First
Quarter
|
3.59
|
1.81
|
|
Second
Quarter
|
3.07
|
1.89
|
|
Third
Quarter
|
2.05
|
0.86
|
|
Fourth
Quarter
|
1.00
|
0.60
|
|
Fiscal
Year Ending December 31, 2009
|
||
|
First
Quarter
|
0.80
|
0.52
|
|
Second
Quarter
|
1.95
|
0.62
|
|
Third
Quarter
|
1.51
|
1.15
|
|
Fourth
Quarter
|
1.20
|
1.68
|
|
Month
Ended
|
||
|
July
2009
|
1.37
|
1.19
|
|
August
2009
|
1.39
|
1.15
|
|
September
2009
|
1.51
|
1.21
|
|
October
2009
|
1.68
|
1.40
|
|
November
2009
|
1.45
|
1.20
|
|
December
2009
|
1.60
|
1.24
|
</R>
|
*
|
Share
price information has been adjusted for the one-for-ten stock
consolidation which became effective on January 18,
2008.
|
</R>
On January
25, 2010, the closing price of our ADSs as reported on the Nasdaq Capital Market
was U.S. $1.48 per ADS.
Plan
of Distribution
We are
registering the Ordinary Shares on behalf of the selling
shareholders. As used in this prospectus, selling shareholders
includes transferees, donees, pledgees and other successors in interest selling
Ordinary Shares or ADSs received from a selling shareholder after the date of
this prospectus. The selling shareholders will receive all of the net
proceeds from the sale of Ordinary Shares or ADSs under this
prospectus. We will bear all costs, expenses and fees incurred by us
in connection with the registration of the Ordinary Shares offered by this
prospectus. The selling shareholders will bear brokerage commissions
and similar selling expenses, if any, attributable to the sale of Ordinary
Shares or ADSs, as well as any fees and disbursements of counsel to the selling
shareholders. Selling shareholders may effect sales of Ordinary
Shares or ADSs from time to time in one or more types of negotiated transactions
or otherwise at fixed prices, prevailing market prices, at varying prices
determined at the time of sale or at negotiated prices as the selling
shareholders determine. Alternatively, the selling shareholders may
from time to time effect sales of ADSs representing Ordinary Shares in one or
more types of transactions on the Nasdaq Capital Market, which may include block
transactions, in the over-the-counter market, through options transactions
relating to the ADSs, or a combination of such methods of sale, at market prices
prevailing at the time of sale, or at negotiated prices. Selling
shareholders also may resell all or a portion of their Ordinary Shares or ADSs
in open market transactions in reliance upon Rule 144 under the Securities
Act, provided they meet the criteria, and conform to the requirements, of such
rule. Any of the transactions described above may or may not involve
brokers or dealers. To the Company’s knowledge, the selling
shareholders have not entered into any agreements, understandings or
arrangements with any underwriters or broker-dealers regarding the sale of their
securities, nor is there an underwriter or coordinating broker acting in
connection with the proposed sale of Ordinary Shares or ADSs by the selling
shareholders.
The
selling shareholders may effect transactions by selling Ordinary Shares or ADSs
directly to purchasers or to or through broker-dealers, which may act as agents
or principals. Such broker-dealers may receive compensation in the
form of discounts, concessions, or commissions from the selling shareholders
and/or the purchasers of Ordinary Shares or ADSs for whom such broker-dealers
may act as agents or to whom they sell as principal, or
both. Compensation as to a particular broker-dealer might be in
excess of customary commissions.
-37-
The
selling shareholders and any broker-dealers that act in connection with the sale
of Ordinary Shares or ADSs might be deemed to be “underwriters” within the
meaning of Section 2(11) of the Securities Act, and any commissions
received by such broker-dealers and any profit on the resale of the Ordinary
Shares or ADSs sold by them while acting as principals might be deemed to be
underwriting discounts or commissions under the Securities Act. We
have agreed to indemnify the selling shareholders against certain liabilities,
including liabilities arising under the Securities Act. A selling
shareholder may agree to indemnify any agent, dealer or broker-dealer that
participates in a transaction involving the sale of the Ordinary Shares or ADSs
against certain liabilities, including liabilities arising under the Securities
Act.
Because
selling shareholders may be deemed to be “underwriters” within the meaning of
Section 2(11) of the Securities Act, the selling shareholders will be
subject to the prospectus delivery requirements of the Securities
Act. The selling shareholders have agreed not to take any action that
would constitute a violation of U.S. federal or state or foreign securities
laws, including Regulation M under the Exchange
Act. Regulation M generally provides that, during an offering by
selling shareholders, such shareholders may not bid for, purchase, or attempt to
induce any person to bid for or purchase, the securities being
offered.
Upon a
selling shareholder notifying us that he, she or it has entered into any
material arrangement with a broker-dealer for the sale of Ordinary Shares or
ADSs through a block trade, special offering, exchange distribution or secondary
distribution or a purchase by a broker or dealer, we will file a supplement
to this prospectus, if required, pursuant to Rule 424(b) under the
Securities Act,
disclosing (i) the name of each such
selling shareholder and of the participating broker-dealer(s), (ii) the
number of Ordinary Shares or ADSs involved, (iii) the price at which such
Ordinary Shares or ADSs were sold, (iv) the commissions paid or discounts
or concessions allowed to such broker-dealer(s), where applicable, (v) that
such broker-dealers(s) did not conduct any investigation to verify the
information set out or incorporated by reference in this prospectus and
(vi) other facts material to the transaction.
Markets
Information
regarding the Company’s trading market for its securities is disclosed under
Item 9.C of the 2008 Annual Report, which is incorporated by reference
herein.
Selling
Shareholders
Pursuant
to a Securities Purchase Agreement, dated as of December 16, 2005, among the
Company and the purchasers party thereto, the Company issued warrants (the “2005
Warrants”) to purchase Ordinary Shares to certain of the selling shareholders
listed below.
Pursuant
to the May 2008 Financing, Amarin issued Ordinary Shares and eight preference
shares (which were converted into eight Ordinary Shares in connection with the
2009 Private Placement) to certain of the selling shareholders listed
below.
Pursuant
to the Initial Bridge Financing and Additional Bridge Financing, Amarin issued
Bridge Warrants to purchase Ordinary Shares to certain of the selling
shareholders listed below.
On
October 16, 2009, pursuant to the 2009 Private Placement, the Company issued
Ordinary Shares and 2009 Warrants to purchase Ordinary Shares to certain of the
selling shareholders listed below. Since the 2009 Private Placement,
the Company has issued to certain executives of Amarin, listed below as selling
shareholders, the Executive Warrants, having substantially the same terms as the
2009 Warrants, to purchase Ordinary Shares.
In the
aggregate, selling shareholders are offering up to 119,512,556 Ordinary Shares,
each represented by one ADS, in connection with this offering.
-38-
The
following table sets forth certain information provided to us by the selling
shareholders regarding the Ordinary Shares beneficially owned by such selling
shareholders as of January 26, 2010, and as adjusted to reflect the sale of the
Ordinary Shares offered by the selling shareholders under this
prospectus. The selling shareholders may sell all, some or none of
their Ordinary Shares in this offering. This table assumes that all
Ordinary Shares being offered under this prospectus are sold in the
offering. The first and second columns reflect the number of Ordinary
Shares owned by each selling shareholder. The third column reflects
the aggregate number of Ordinary Shares being offered by the selling
shareholders. To our knowledge, each of the selling shareholders has
sole investment power and sole voting power, except where joint ownership is
indicated. Except as set forth below, none of the selling
shareholders holds or has held within the past three years any position or
office with us. To our knowledge, except as set forth below, none of
the selling shareholders has or has had within the past three years any material
relationships with us.
|
Selling
Shareholder
|
Ordinary
Shares
Owned
Prior
to
Offering
(Including Ordinary Shares underlying warrants)
|
Percentage
of
Ordinary
Shares
Owned
Prior
to
Offering(1)
|
Ordinary
Shares
to be
Offered
|
Ordinary
Shares
to be
owned
upon
completion
of
offering
|
Percentage
of
Ordinary
Shares
to be
owned
upon
completion
of
offering
|
|
Caduceus
Private Investments III, LP(2)(4)(5)
c/o
OrbiMed Advisors, LLC
767
Third Avenue
30th
Floor
New
York, NY 10017
|
13,631,051
|
13.33%
|
13,631,051
|
0
|
0%
|
|
OrbiMed
Associates III, LP(2)(4)(5)
c/o
OrbiMed Advisors, LLC
767
Third Avenue
30th
Floor
New
York, NY 10017
|
129,821
|
0.13%
|
129,821
|
0
|
0%
|
|
Sofinnova
Venture Partners VII, L.P.(2)(4)(5)
c/o
Sofinnova Management VII, L.L.C.
850
Oak Grove Avenue
Menlo
Park, CA 94025
|
14,086,958
|
13.77%
|
14,086,958
|
0
|
0%
|
|
Longitude
Venture Partners, L.P.(2)(4)(5)
c/o
Longitude Capital Partners, LLC
800
El Camino Real
Ste
220
Menlo
Park, CA 94025
|
6,233,797
|
6.20%
|
6,233,797
|
0
|
0%
|
-39-
|
Selling
Shareholder
|
Ordinary
Shares
Owned
Prior
to
Offering
(Including Ordinary Shares underlying warrants
|
Percentage
of
Ordinary
Shares
Owned
Prior
to
Offering(1)
|
Ordinary
Shares
to be
Offered
|
Ordinary
Shares
to be
owned
upon
completion
of
offering
|
Percentage
of
Ordinary
Shares
to be
owned
upon
completion
of
offering
|
|
Longitude
Capital Associates, L.P.(2)(4)(5)
c/o
Longitude Capital Partners, LLC
800
El Camino Real
Ste
220
Menlo
Park, CA 94025
|
103,161
|
0.10%
|
103,161
|
0
|
0%
|
|
Fountain
Healthcare Partners Fund I, L.P.(2)(4)(5)
c/o
Fountain Healthcare Partners Ltd.
Guild
House, 4th
Floor Guild Street, IFSC Dublin 1, Ireland
|
7,717,391
|
7.62%
|
7,717,391
|
0
|
0%
|
|
Stichting
Depositary APG(4) Developed Markets Equity Pool
PO
Box 75283
1070
AG Amsterdam
The
Netherlands
|
10,875,000
|
10.62%
|
10,875,000
|
0
|
0%
|
|
Abingworth
Bioventures V L.P.(4)(5)
c/o
Abingworth LLP
38
Jermyn St.
London
SW1Y 6DN,
United
Kingdom
|
11,250,000
|
10.97%
|
11,250,000
|
0
|
0%
|
|
Abingworth
Bioventures V Co-Invest Growth Equity Fund LP(4)(5)
c/o
Abingworth LLP
38
Jermyn St.
London
SW1Y 6DN
United
Kingdom
|
11,250,000
|
10.97%
|
11,250,000
|
0
|
0%
|
|
Abingworth
Bioequities Master Fund Limited(4)(5)
c/o
Abingworth LLP
38
Jermyn St.
London
SW1Y 6DN
United
Kingdom
|
3,000,000
|
3.01%
|
3,000,000
|
0
|
0%
|
|
Biomedical
Offshore Value Fund, Ltd.(4)
c/o
Great Point Partners, LLC
165
Mason Street
3rd
Floor
Greenwich,
CT 06830
|
3,621,000
|
3.62%
|
3,621,000
|
0
|
0%
|
|
Biomedical
Value Fund, L.P.(4)
c/o
Great Point Partners, LLC
165
Mason Street
3rd
Floor
Greenwich,
CT 06830
|
7,029,000
|
6.95%
|
7,029,000
|
0
|
0%
|
-40-
|
Selling
Shareholder
|
Ordinary
Shares
Owned
Prior
to
Offering
(Including Ordinary Shares underlying warrants
|
Percentage
of
Ordinary
Shares
Owned
Prior
to
Offering(1)
|
Ordinary
Shares
to be
Offered
|
Ordinary
Shares
to be
owned
upon
completion
of
offering
|
Percentage
of
Ordinary
Shares
to be
owned
upon
completion
of
offering
|
|
Visium
Balanced Master Fund, Ltd. (4)
c/o
Visium Asset Management
950
Third Avenue
29th
Floor
New
York, NY 10022
|
3,600,000
|
3.60%
|
3,600,000
|
0
|
0%
|
|
Opus
Point Healthcare Innovations Fund, L.P.(4)
787
Seventh Avenue
48th
Floor
New
York, NY 10019
|
337,500
|
0.34%
|
337,500
|
0
|
0%
|
|
Opus
Point Healthcare Value Fund, L.P.(4)
787
Seventh Avenue
48th
Floor
New
York, NY 10019
|
337,500
|
0.34%
|
337,500
|
0
|
0%
|
|
Opus
Point Healthcare (Low Net) Fund, L.P.(4)
787
Seventh Avenue
48th
Floor
New
York, NY 10019
|
150,000
|
0.15%
|
150,000
|
0
|
0%
|
|
Opus
Point Capital Preservation Fund, L.P.(4)
787
Seventh Avenue
48th
Floor
New
York, NY 10019
|
300,000
|
0.30%
|
300,000
|
0
|
0%
|
|
Capital
Ventures International(4)
c/o
Heights Capital Management
101
California St
Suite
3250
San
Francisco, CA 94111
|
1,350,000
|
1.36%
|
1,350,000
|
0
|
0%
|
|
Cummings
Bay Capital(4)
96
Cummings Point Road
Stamford,
CT 06902
|
255,000
|
0.26%
|
255,000
|
0
|
0%
|
|
Geneve
Corp(4)
96
Cummings Point Road
Stamford,
CT 06902
|
120,000
|
0.12%
|
120,000
|
0
|
0%
|
|
BioHedge
Holdings Limited(4)
c/o
Investor Company
77
Bloor St. W.
3rd
Floor
Toronto,
Ontario
M4Y
2T1
|
142,014
|
0.14%
|
142,014
|
0
|
0%
|
|
Rosalind
Capital Partners, L.P.(4)
c/o
Investor Company
77
Bloor St. W.
3rd
Floor
Toronto,
Ontario
M4Y
2T1
|
232,986
|
0.24%
|
232,986
|
0
|
0%
|
-41-
|
Selling
Shareholder
|
Ordinary
Shares
Owned
Prior
to
Offering
(Including Ordinary Shares underlying warrants
|
Percentage
of
Ordinary
Shares
Owned
Prior
to
Offering(1)
|
Ordinary
Shares
to be
Offered
|
Ordinary
Shares
to be
owned
upon
completion
of
offering
|
Percentage
of
Ordinary
Shares
to be
owned
upon
completion
of
offering
|
|
Boxer
Capital LLC(4)
445
Marine View Ave 100,
Delmar,
CA 92104
|
4,875,000
|
4.85%
|
4,875,000
|
0
|
0%
|
|
RCG
PB Ltd.(4)
c/o
Ramius LLC
599
Lexington Ave.
20th
Floor
New
York, NY 10022
|
506,250
|
0.51%
|
506,250
|
0
|
0%
|
|
Ramius
Enterprise Master Fund Ltd.(4)
c/o
Ramius LLC
599
Lexington Ave.
20th
Floor
New
York, NY 10022
|
168,750
|
0.17%
|
168,750
|
0
|
0%
|
|
RA
Capital Healthcare Fund, L.P.(4)
800
Boylston Street
Suite
1500
Boston,
MA 02199
|
5,061,030
|
5.04%
|
5,061,030
|
0
|
0%
|
|
Blackwell
Partners, LLC(4)
c/o
RA Capital Management, LLC
800
Boylston Street
Suite
1500
Boston,
MA 02199
|
638,970
|
0.65%
|
638,970
|
0
|
0%
|
|
David
Brabazon(3)(4)
47
Mount Prospect Avenue
Clontarf,
Dublin 3
|
665,013
|
0.67%
|
665,013
|
0
|
0%
|
|
David
Hurley(3)(4)
8
Killiney Heath, Killiney
Co.
Dublin
|
525,620
|
0.53%
|
525,620
|
0
|
0%
|
|
Eunan
Maguire(4)
517
S. 2nd
Street
Philadelphia,
PA 19147
|
271,732
|
0.27%
|
271,732
|
0
|
0%
|
|
Anthony
Russell Roberts(4)(6)
Wuartier
Les Brunes
83340
Le Thoronet
France
|
75,000
|
0.08%
|
75,000
|
0
|
0%
|
|
Sunninghill
Limited(2)(3)(4)(7)
PO
Box 76
Kleinwort
Benson House
Wests
Centre, St. Helier
Jersey
JE4 8PQ
Channel
Islands
|
5,544,436
|
5.46%
|
5,544,436
|
0
|
0%
|
|
Midsummer
Ventures, LP(3)(4)
c/o
Midsummer Advisors, LLC
295
Madison Avenue
38th
Floor
New
York, NY 10017
|
1,249,998
|
1.26%
|
1,249,998
|
0
|
0%
|
-42-
|
Selling
Shareholder
|
Ordinary
Shares
Owned
Prior
to
Offering
(Including Ordinary Shares underlying warrants
|
Percentage
of
Ordinary
Shares
Owned
Prior
to
Offering(1)
|
Ordinary
Shares
to be
Offered
|
Ordinary
Shares
to be
owned
upon
completion
of
offering
|
Percentage
of
Ordinary
Shares
to be
owned
upon
completion
of
offering
|
|
Midsummer
Investment, Limited(3)(4)
c/o
Midsummer Advisors, LLC
295
Madison Avenue
38th
Floor
New
York, NY 10017
|
833,331
|
0.84%
|
833,331
|
0
|
0%
|
|
Amarin
Investment Holdings Limited (Thomas G. Lynch) (3)(4)(8)
Clarendon
House
2
Church Street
Hamilton
MH11
Bermuda
|
1,076,345
|
1.08%
|
1,076,345
|
0
|
0%
|
|
Dr.
Simon Kukes(2)(3)(4)(9)
Samara
Nafta
Smolensky
Blvd.
4
Moscow 119034
Russia
|
933,620
|
0.94%
|
933,620
|
0
|
0%
|
|
Maximus
Lachman(3)(9)
298
Greenway Road
Ridgewood,
NJ 07450
|
41,666
|
0.04%
|
41,666
|
0
|
0%
|
|
Samson
Lachman(3)(9)
298
Greenway Road
Ridgewood,
NJ 07450
|
41,666
|
0.04%
|
41,666
|
0
|
0%
|
|
Michael
Walsh(2)(3)(10)
45
Wellington Road
Ballsbridge
Dublin
4, Ireland
|
81,105
|
0.08%
|
81,105
|
0
|
0%
|
|
Southpoint
Fund LP
623
Fifth Avenue
25th
Floor
New
York, NY 10022
|
25,251
|
0.03%
|
25,251
|
0
|
0%
|
|
Southpoint
Qualified Fund LP
623
Fifth Avenue
25th
Floor
New
York, NY 10022
|
109,222
|
0.11%
|
109,222
|
0
|
0%
|
|
Southpoint
Offshore Operating Fund LP
623
Fifth Avenue
25th
Floor
New
York, NY 10022
|
125,426
|
0.13%
|
125,426
|
0
|
0%
|
|
Bloxhams
(Nominee Account)
2-3
Exchange Place
IFSC
Dublin
1, Ireland
|
61,600
|
0.06%
|
61,600
|
0
|
0%
|
|
Fort
Mason Partners, L.P.
456
Montgomery Street, 22nd Floor
San
Francisco, CA 94115
|
5,276
|
0.01%
|
5,276
|
0
|
0%
|
-43-
|
Selling
Shareholder
|
Ordinary
Shares
Owned
Prior
to
Offering
(Including Ordinary Shares underlying warrants
|
Percentage
of
Ordinary
Shares
Owned
Prior
to
Offering(1)
|
Ordinary
Shares
to be
Offered
|
Ordinary
Shares
to be
owned
upon
completion
of
offering
|
Percentage
of
Ordinary
Shares
to be
owned
upon
completion
of
offering
|
|
Fort
Mason Master, L.P.
456
Montgomery Street, 22nd Floor
San
Francisco, CA 94115
|
81,357
|
0.08%
|
81,357
|
0
|
0%
|
|
Biotechnology
Value Fund, L.P.
1
Sansome Street
39th
Floor
San
Francisco, CA 94104
|
28,069
|
0.03%
|
28,069
|
0
|
0%
|
|
Biotechnology
Value Fund II, L.P.
1
Sansome Street
39th
Floor
San
Francisco, CA 94104
|
17,673
|
0.02%
|
17,673
|
0
|
0%
|
|
BVF
Investments L.L.C.
1
Sansome Street
39th
Floor
San
Francisco, CA 94104
|
51,980
|
0.05%
|
51,980
|
0
|
0%
|
|
Investment
10 L.L.C.
1
Sansome Street
39th
Floor
San
Francisco, CA 94104
|
6,237
|
0.01%
|
6,237
|
0
|
0%
|
|
Domain
Public Equity Partners
One
Palmer Square
Suite
515
Princeton,
NJ 08542
|
51,980
|
0.05%
|
51,980
|
0
|
0%
|
|
IIU
Nominees Limited
IFSC
House
Custom
House Quay
Dublin
1
Ireland
|
24,257
|
0.02%
|
24,257
|
0
|
0%
|
|
Enable
Opportunity Partners LP
One
Ferry Building
Suite
255
San
Francisco, CA 94111
|
1,765
|
0.00%
|
1,765
|
0
|
0%
|
|
Enable
Growth Partners LP
One
Ferry Building
Suite
255
San
Francisco, CA 94111
|
7,061
|
0.01%
|
7,061
|
0
|
0%
|
|
Lyrical
Opportunity Partners ,L.P.
152
W 57th Street
33rd
Floor
New
York, NY 10019
|
13,861
|
0.01%
|
13,861
|
0
|
0%
|
|
Lyrical
Multi-Manager Offshore Fund, Ltd
152
W 57th Street
33rd
Floor
New
York, NY 10019
|
10,396
|
0.01%
|
10,396
|
0
|
0%
|
|
Lyrical
Multi-Manager Fund, L.P
152
W 57th Street
33rd
Floor
New
York, NY 10019
|
13,861
|
0.01%
|
13,861
|
0
|
0%
|
-44-
|
Selling
Shareholder
|
Ordinary
Shares
Owned
Prior
to
Offering
(Including Ordinary Shares underlying warrants
|
Percentage
of
Ordinary
Shares
Owned
Prior
to
Offering(1)
|
Ordinary
Shares
to be
Offered
|
Ordinary
Shares
to be
owned
upon
completion
of
offering
|
Percentage
of
Ordinary
Shares
to be
owned
upon
completion
of
offering
|
|
Jeffrey
Keswin
152
W 57th Street
33rd
Floor
New
York, NY 10019
|
25,990
|
0.03%
|
25,990
|
0
|
0%
|
|
Option
Opportunities Corp
440
South LaSalle Street
Suite
2301
Chicago,
IL 60605
|
10,396
|
0.01%
|
10,396
|
0
|
0%
|
|
Davy
Crest Nominees Ltd.
Davy
House
49
Dawson Street
Dublin
1
Ireland
|
8,750
|
0.01%
|
8,750
|
0
|
0%
|
|
Peter
F. Levonowich
c/o
Petroval
84
Avenue Louis Casai
1216
Cointrin
Geneva
Switzerland
|
6,930
|
0.01%
|
6,930
|
0
|
0%
|
|
Seamus
Mulligan
18
Ailesbury Road
Ballsbridge
Dublin
4
Ireland
|
5,198
|
0.01%
|
5,198
|
0
|
0%
|
|
John
Groom
Mardleybury
Manor
Woolmer
Green
Knebworth
Herts
SG3 6LU
|
5,509
|
0.01%
|
5,509
|
0
|
0%
|
|
Jacob
Tal
PO
Box 7269
Reno,
NV 89510
|
3,465
|
0.00%
|
3,465
|
0
|
0%
|
|
Tiarnan
O’Mahoney
Glen
Pines
Old
Lone Hill Road
Enniskerry
Co
Wicklow
Ireland
|
3,464
|
0.00%
|
3,464
|
0
|
0%
|
|
Mayoran
LTD
HMYASDIM
Ramot
Hshvim
Israel
|
2,771
|
0.00%
|
2,771
|
0
|
0%
|
|
Ori
Shilo
12
Dufna SA,
Tel
Aviv
64926
Israel
|
2,287
|
0.00%
|
2,287
|
0
|
0%
|
|
Shane
M. Cooke
Kirriemuir
Stillorgan
Park
Dublin
Ireland
|
1,732
|
0.00%
|
1,732
|
0
|
0%
|
-45-
|
Selling
Shareholder
|
Ordinary
Shares
Owned
Prior
to
Offering
(Including Ordinary Shares underlying warrants
|
Percentage
of
Ordinary
Shares
Owned
Prior
to
Offering(1)
|
Ordinary
Shares
to be
Offered
|
Ordinary
Shares
to be
owned
upon
completion
of
offering
|
Percentage
of
Ordinary
Shares
to be
owned
upon
completion
of
offering
|
|
Alan
Cooke(11)
60
Sandford Road
Ranelagh
Dublin
6
Ireland
|
248,609
|
0.25%
|
248,609
|
0
|
0%
|
|
Tom
Maher(12)
Rear
of 66 Tritonville Road
Sandymount
Dublin
4
Ireland
|
157,648
|
0.16%
|
157,648
|
0
|
0%
|
|
Nigel
Clerkin
18
Lower Beechwood Avenue
Dublin
6
Ireland
|
346
|
0.00%
|
346
|
0
|
0%
|
|
Emer
Reynolds
31
Churchfields
Milltown
Dublin
14
Ireland
|
346
|
0.00%
|
346
|
0
|
0%
|
|
Kevin
Insley
102
St James Court
Flatts
Smiths
FL-04
Bermuda
|
3,500
|
0.00%
|
3,500
|
0
|
0%
|
|
ProSeed
Capital Holdings CVA
Vlierbeekberg
107
3090
Overijse
Belgium
|
866
|
0.00%
|
866
|
0
|
0%
|
|
Robert
Butler
105
Henry Street
Limerick
Ireland
|
17,500
|
0.01%
|
17,500
|
0
|
0%
|
|
Rick
Stewart(13)
25
St Georges Road
Twickenham
London
TW1 1QR
|
866
|
0.00%
|
866
|
0
|
0%
|
|
Dr
Anthony Ryan
Park
Palace, Block B
6
Impasse de la Fountaine
Monte
Carlo, 98000
Monacoville
|
28,000
|
0.03%
|
28,000
|
0
|
0%
|
|
Richard
Strappe
Mount
Judkin
Cashel,
Co. Tipperary
Republic
of Ireland
|
1,400
|
0.00%
|
1,400
|
0
|
0%
|
|
Total
|
119,512,556
|
117.84%
|
119,512,556
|
0
|
0%
|
-46-
<R>
|
(1)
|
Based
on the number of Ordinary Shares outstanding on January 26, 2010, and
calculated in accordance with Rule 13d-3 of the Exchange
Act.
|
</R>
|
(2)
|
An
investor in the May 2008 Financing.
|
|
(3)
|
A
lender under the Initial Bridge Financing or the Additional Bridge
Financing.
|
|
(4)
|
An
investor in the 2009 Private Placement. Pursuant to the 2009
Private Placement, each investor has certain registration rights and
rights of first refusal to purchase up to its pro rata share of any
offering by the Company of Ordinary Shares or any other class or series of
its capital stock.
|
|
(5)
|
In
connection with the 2009 Private Placement, the Company entered into a
Management Rights Deed of Agreement (the “Management Agreement”) with
certain of the investors pursuant to which the Company agreed to cause the
board of directors of the Company to nominate for election to the board of
directors (i) one director designated by each of (x) Caduceus Private
Investments III, LP (and its affiliates, including OrbiMed Associates III,
LP), (y) Sofinnova Venture Partners VII, L.P. (and its affiliates) and (z)
Fountain Healthcare Partners Fund I, L.P. (and its affiliates), for so
long as such party (each a “Lead Investor” and together, the “Lead
Investors”) and its affiliates, in the aggregate, beneficially owns a
number of Ordinary Shares equal to at least 50% of the Ordinary Shares
purchased by it in the 2009 Private Placement, (ii) two independent
directors designated by the Lead Investors, for so long as the Lead
Investors and their respective affiliates beneficially own in the
aggregate a number of Ordinary Shares equal to at least 25% of the
outstanding Ordinary Shares of the Company and (iii) a director designated
by Abingworth LLP and its affiliates, for so long as Abingworth LLP and
its affiliates beneficially own in the aggregate a number of Ordinary
Shares equal to at least 5% of the outstanding Ordinary Shares of the
Company. Each of the parties to the Management Agreement agreed to vote
all Ordinary Shares and ADSs held by such party in favor of the election
to the board of directors of the directors designated by the Lead
Investors and Abingworth.
|
|
(6)
|
Served
as director from April 7, 2000 to October 16,
2009.
|
|
(7)
|
An
entity controlled by Dr. John Climax who served as director from March 20,
2006 to October 16, 2009.
|
|
(8)
|
An
entity controlled by a director Mr. Thomas Lynch who served as chairman
until January 1, 2010.
|
|
(9)
|
Family
member of a director who served from January 1, 2005 to May 16,
2008.
|
|
(10)
|
Served
as director from January 1, 2005 to May 16,
2008.
|
|
(11)
|
Served
as director from May 2004 to May 16, 2008 and chief financial officer from
May 2004 to October 31, 2009.
|
<R>
|
(12)
|
Appointed
General Counsel from February 2006. On December 10, 2009,
Amarin entered into a Compromise Agreement with Tom Maher pursuant to
which Mr. Maher’s employment by the Company will terminate on January 29,
2010. Until such time, Mr. Maher’s title will be Interim
General Counsel and Company
Secretary.
|
</R>
|
(13)
|
Served
as director from November 23, 1998 to December 19, 2007 and chief
executive officer from 2002 to November 19,
2007.
|
Dilution
The
securities registered hereby are Ordinary Shares that, when sold by the selling
shareholders, will already be issued and outstanding. Accordingly,
there will be no dilution to the Company’s shareholders from the sale of such
Ordinary Shares.
-47-
Expenses
of the Issue
We will
bear all costs, expenses and fees incurred by us in connection with the
registration of the Ordinary Shares offered by this prospectus. The
selling shareholders will bear brokerage commissions and similar selling
expenses, if any, attributable to the sale of Ordinary Shares or ADSs, as well
as any fees and disbursements of counsel to the selling
shareholders. The price paid for the Ordinary Shares by the selling
shareholders pursuant to the 2009 Private Placement included costs of issuance,
such as any stamp duty or stamp duty reserve tax with respect thereto or any
other cost incurred by the Company in connection with the issuance of the
securities. Under the terms of the 2009 Warrants, the Company will
bear the brokerage commissions and other reasonable expenses associated with a
cashless exercise by the holder thereof.
The
following table sets forth the estimated expenses paid or payable by us in
connection with the May 2008 Financing, the 2009 Private Placement and the
offering described in this registration statement. All amounts are
subject to future contingencies other than the SEC registration
fee.
|
Oct-09
US$
|
May-08
US$
|
Total
US$
|
||||||||||
|
Securities
and Exchange Commission Registration Fee
|
— | 1,043 | 1,043 | |||||||||
|
Placement
Fees and Expenses related to the Private Placement
|
1,344,628 | 1,880,950 | 3,225,578 | |||||||||
|
Legal
Fees and Expenses
|
1,278,268 | 1,045,000 | 2,323,268 | |||||||||
|
Initial
Stamp Duty*
|
1,050,000 | 450,000 | 1,500,000 | |||||||||
|
Miscellaneous
|
— | 316,000 | 316,000 | |||||||||
|
Total
|
3,672,896 | 3,692,993 | 7,365,889 | |||||||||
* Stamp
duty reserve tax is imposed upon the conversion of the Ordinary Shares being
registered hereunder into ADSs and is payable at a rate of 1.5%. The
stamp duty or stamp duty reserve tax incurred by the Company in connection with
the issuance of the securities was included in the price paid for the Ordinary
Shares by the selling shareholders pursuant to private placements.
ADDITIONAL
INFORMATION
Share
Capital
<R>
Our
authorized capital stock consists of 155,914,406 Ordinary Shares, par value
£0.50 per share, and 440,855,854 Preference Shares, par value £0.05 per share,
of which 98,801,982 Ordinary Shares and no Preference Shares were issued as of
January 26, 2010. Amarin holds 20 Ordinary Shares as treasury
stock. Each outstanding share is fully paid.
On
January 1, 2010, Amarin had outstanding 27,046,716 Ordinary Shares and 8 Series
A Preference Shares. Between January 1, 2009 and December 31, 2009,
we issued 71,755,258 Ordinary Shares in the transactions described in the
following table and eight Series A Preference Shares were converted into eight
Ordinary Shares in connection with the 2009 Private Placement. The
following table summarizes the history of our share capital for the last three
years, including changes in the number, classes and voting rights
thereof.
-48-
|
Year
ended
December
31, 2007
|
Year
ended
December
31, 2008
|
Year
ended
December
31, 2009
|
||||||||||||||||||||||
|
No.
of shares
|
$ | ’000 |
No.
of shares
|
$ | ’000 |
No.
of shares(5)
|
$ | ’000 | ||||||||||||||||
|
Opening
balance
|
9,068,436 | 7,990 | 13,905,737 | 11,994 | 27,046,716 | 21,287 | ||||||||||||||||||
|
Capital
Raising(1)
|
2,294,635 | 2,336 | 13,140,979 | 12,986 | 70,400,004 | 56,857 | ||||||||||||||||||
|
Issued
on Acquisition(2)
|
2,500,000 | 2,574 | — | — | 1,355,262 | 1,144 | ||||||||||||||||||
|
Shares
issued on Exercise of Warrants(3)
|
42,000 | 42 | — | — | — | — | ||||||||||||||||||
|
Shares
issued Exercise of Share Options(4)
|
666 | — | — | — | — | — | ||||||||||||||||||
|
Transaction
costs incurred
|
— | (948 | ) | — | (3,693 | ) | — | (3,673 | ) | |||||||||||||||
|
Closing
Balance
|
13,905,737 | 11,994 | 27,046,716 | 21,287 | 98,801,982 | 75,615 | ||||||||||||||||||
</R>
|
(1)
|
In
December, 2007, the Company issued a total of 1,629,086 Ordinary Shares in
consideration for $5,376,000 and warrants to purchase 1,043,704 Ordinary
Shares with an exercise price of $4.80 per share in a registered direct
offering.
|
<R>
|
|
In
June, 2007, the Company and an affiliate of a former shareholder,
Southridge Capital, entered into an equity line of credit
agreement. A one time fee of $300,000, settled in Ordinary
Shares, was paid to Southridge in connection with the
agreement.
|
</R>
|
|
In
June, 2007, the Company issued a total of 615,633 Ordinary Shares in
consideration for $3,700,000 and warrants to purchase 61,559 Ordinary
Shares with an exercise price of $7.20 per share in a registered direct
offering.
|
|
|
In
May 2008, the Company issued 13,043,479 Ordinary Shares and 8 Series A
Preference Shares in a private placement of equity in consideration for
$30,000,000 to institutional investors and certain current and former
directors.
|
|
|
In
January 2008, the Company issued 97,500 Ordinary Shares pursuant to an
agreement with ProSeed Capital
Holdings.
|
|
|
Pursuant
to the 2009 Private Placement, the Company issued 70,399,996 Ordinary
Shares in consideration for $70,000,000 and warrants to purchase
35,199,996 shares with an exercise price of $1.50 in a private placement
and converted eight Series A Preference Shares into eight Ordinary
Shares. Pursuant to a Management Rights Deed of Agreement
executed in connection with the 2009 Private Placement, the Company’s
Board is obligated to nominate for election to the Board six individuals
nominated by the Lead Investors and
Abingworth.
|
|
(2)
|
In
December 2007, the Company issued a total of 2,500,000 Ordinary Shares in
consideration for the acquisition of Ester Neurosciences
Limited.
|
|
|
In
August 2009, the Company issued 1,315,789 Ordinary Shares pursuant to an
Amendment and Waiver Agreement between the Company and the former
shareholders of Ester Neurosciences
Limited.
|
|
|
In
October 2009, the Company issued 39,473 Ordinary Shares pursuant to a
collaboration agreement between the Company and ProSeed Capital Holdings
CVA.
|
|
(3)
|
In
April 2007, the Company issued 42,000 Ordinary Shares due to the exercise
of warrants in aggregate for the total consideration of
$600,600. These warrants were issued as part of the financing
completed in December 2005
|
-49-
|
(4)
|
In
the twelve months to December 31, 2007, the Company issued 666 Ordinary
Shares due to the exercise of share options in aggregate for a total
consideration of $8,000.
|
|
(5)
|
On
January 18, 2008, our Ordinary Shares were consolidated on a one-for-ten
basis whereby ten Ordinary Shares of £0.05 each became one Ordinary Share
of £0.50. Historical information in respect of 2007 has been adjusted to
reflect the share consolidation.
|
For a
capitalization table showing our outstanding warrants and options, including the
exercise price and expiration dates thereof and the number of Ordinary Shares
covered thereby, see “Description of Securities Other than Equity
Securities—Warrants and Rights”.
The
issuance of the Ordinary Shares registered hereby was authorized by our Board of
Directors pursuant to resolutions approving the transactions in which such
Ordinary Shares, or the securities exercisable for such Ordinary Shares, were
issued.
Memorandum
and Articles of Association
Information
regarding the Company’s memorandum and articles of association is disclosed
under Item 10.B of the 2008 Annual Report, which is incorporated by
reference herein.
Material
Contracts
Information
regarding the Company’s material contracts is disclosed under Item 10.C of the
2008 Annual Report, which is incorporated by reference herein.
Exchange
Controls
There are
currently no U.K. foreign exchange controls that may affect the export or import
of capital, including the availability of cash and cash equivalents for use by
the Group, or that affect the remittance of dividends, interest or other
payments to non-U.K. resident holders of Ordinary Shares or ADSs.
Taxation
Information
regarding certain Irish and U.S. tax considerations with respect to the
purchase, ownership and disposition of Ordinary Shares or ADSs is disclosed
under Item 10.E of the 2008 Annual Report, which is incorporated by reference
herein.
Dividends
and Paying Agents
None.
Documents
on Display
We file
reports and other information with the SEC pursuant to the rules and regulations
of the SEC that apply to foreign private issuers. We also 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 IFRS.
As a
foreign private issuer, we are exempt from the rules under the Exchange Act
prescribing the furnishing and content of proxy statements, and our officers,
directors and principal shareholders are exempt from the reporting and
short-swing profit recovery provisions contained in Section 16 of the Exchange
Act. In addition, we are
-50-
not
required under the Exchange Act to file periodic reports and financial
statements with the Securities and Exchange Commission as frequently or as
promptly as United States companies whose securities are registered under the
Exchange Act.
For more
information, see “Where You Can Find More Information” above.
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Information
regarding foreign exchange rate risks and interest rate risks faced by the
Company is disclosed under Item 11 of the 2008 Annual Report, which is
incorporated by reference herein.
DESCRIPTION
OF SECURITIES OTHER THAN EQUITY SECURITIES
Debt
Securities
Not
applicable.
Warrants
and Rights
The
following table summarizes our outstanding warrants and options, including the
exercise price and expiration dates thereof and the number of Ordinary Shares
covered thereby.
<R>
|
AMARIN
CAPITALIZATION TABLE
INFORMATION
AS AT JANUARY 26, 2010
|
|||||||||
|
Number
of Shares
|
Exercise
Price
|
Expiration
Date
|
|||||||
|
Common
Stock
|
|||||||||
|
Shares
outstanding as at January 26, 2010
|
98,801,982 | ||||||||
|
Warrants
attached to:
|
|||||||||
|
December
2005 Private Placement of Equity
|
846,310 | $ | 14.30 |
21-Dec-10
|
|||||
|
January
2006 Private Placement of Equity
|
29,400 | $ | 30.60 |
26-Jan-11
|
|||||
|
Neurostat
Agreement
|
17,500 | $ | 17.90 |
17-Jan-14
|
|||||
|
June
2007 Registered Direct Offering of Equity
|
61,559 | $ | 7.20 |
31-May-12
|
|||||
|
ProSeed
Capital Advisory Agreement
|
3,000 | $ | 6.00 |
20-Jun-10
|
|||||
|
Strategic
Pharmaceuticals Solutions Consultancy Agreement
|
1,000 | $ | 3.40 |
28-Nov-12
|
|||||
|
December
2007 Private Placement of Equity
|
814,538 | $ | 2.99 |
05-Dec-12
|
|||||
|
December
2007 Convertible Debt
|
229,166 | $ | 2.99 |
05-Dec-12
|
|||||
|
Participation
Bridge Warrants
|
3,111,105 | $ | 1.00 |
31-Jul-14
|
|||||
|
October
2009 Private Placement(2)
|
35,199,996 | $ | 1.50 |
16-Oct-14
|
|||||
|
Executive
Warrants(2)
|
904,005 | $ | 1.50 |
16-Oct-14
|
|||||
|
Total
warrants
|
41,217,579 | $ | 1.75 | (1) |
n/a
|
||||
|
Options
|
7,797,266 | $ | 2.71 | (1) |
Various
|
||||
|
Total
Common Stock Equivalent Shares
|
147,816,827 | ||||||||
</R>
|
(1)
|
Weighted
average
|
-51-
|
(2)
|
These
warrants contain a cashless exercise feature and a provision requiring the
Company, in connection with certain acquisition events, to use its best
efforts to have the warrants assumed by the acquirer such that the
substitute warrant has a Black-Scholes value equivalent to the
Black-Scholes value of such warrant (and if, despite such best efforts,
the warrants are not so assumed, they will be settled in cash equal to the
Black-Scholes value of such
warrant).
|
Other
Securities
Not
applicable.
American
Depositary Shares
Citibank,
N.A. acts as the depositary for our American Depositary Shares representing our
Ordinary Shares. Citibank’s depositary offices are located at 388
Greenwich Street, New York, New York 10013. American Depositary
Shares are frequently referred to as “ADSs” and represent ownership interests in
securities that are on deposit with the depositary. ADSs are represented by
certificates that are commonly known as “American Depositary Receipts,” or
“ADRs.” The depositary typically appoints a custodian to safekeep the
securities on deposit. In this case, the custodian is the London
office of Citibank, N.A., located at Citigroup Centre, Canada Square, Canary
Wharf, London E14 5LB, England.
We have
appointed Citibank as depositary for our ADSs representing Ordinary Shares
pursuant to a deposit agreement. A copy of the deposit agreement
(including any amendments) is on file with the SEC under cover of a Registration
Statement on Form F-6. You may obtain a copy of the deposit agreement
from the SEC’s Public Reference Room at 100 F Street, N.E., Room 1580,
Washington, D.C. 20549. Please refer to Registration Numbers
333-147660, 333-123653 and 333-5946 when retrieving such copy. We
will appoint Citibank as depositary pursuant to a new deposit agreement if we
determine to offer and sell preference shares represented by ADSs, which deposit
agreement will be filed with the SEC under cover of a Registration Statement on
Form F-6.
We are
providing you with a summary description of the material terms of the ADSs
representing Ordinary Shares and of the material rights of owners of ADSs
representing Ordinary Shares. We expect that the material terms of
any ADSs representing preference shares and the material rights of owners of any
ADSs representing preference shares will be similar to the material terms of the
ADSs representing Ordinary Shares and the material rights of owners of ADSs
representing Ordinary Shares, as provided in the following summary. A
summary description of any differences in such material terms and material
rights from the description set forth below will be included in a prospectus
supplement. Please remember that summaries by their nature lack the
precision of the information summarized and that a holder’s rights and
obligations as an owner of ADSs will be determined by reference to the terms of
the applicable deposit agreement and not by this summary. If you
intend to hold ADSs, we urge you to review the applicable deposit agreement
(including any amendments) in its entirety. Each ADS representing Ordinary
Shares represents one Ordinary Share on deposit with the custodian and any ADS
representing preference shares will represent one preference share on deposit
with the custodian. An ADS will also represent any other property
received by the depositary or the custodian on behalf of the owner of the ADS
but that has not been distributed to the owners of ADSs because of legal
restrictions or practical considerations.
If you
become an owner of ADSs, you will become a party to the applicable deposit
agreement and therefore will be bound to its terms and to the terms of the ADR
that represents your ADSs. The deposit agreement and the ADR specify
our rights and obligations as well as your rights and obligations as owner of
ADSs and those of the depositary. As an ADS holder you appoint the
depositary to act on your behalf in certain circumstances. The
deposit agreement and the ADRs are governed by New York law. However,
our obligations to the holders of Ordinary Shares and to the holders of
preference shares will continue to be governed by the laws of England and Wales,
which may be different from the laws in the United States.
-52-
As an
owner of ADSs, you may hold your ADSs either by means of an ADR registered in
your name or through a brokerage or safekeeping account. If you
decide to hold your ADSs through your brokerage or safekeeping account, you must
rely on the procedures of your broker or bank to assert your rights as ADS
owner. Please consult with your broker or bank to determine what
those procedures are. This summary description assumes you have opted
to own the ADSs directly by means of an ADR registered in your name and, as
such, we will refer to you as the holder. When we refer to you, we
assume the reader owns ADSs and will own ADSs at the relevant time.
Dividends
and Distributions
As a
holder, you generally have the right to receive the distributions we make on the
securities deposited with the custodian. Your receipt of these
distributions may be limited, however, by practical considerations and legal
limitations. Holders will receive such distributions under the terms
of the deposit agreement in proportion to the number of ADSs held as of a
specified record date.
Distributions of
Cash
Upon
receipt of a cash dividend or other cash distribution, the depositary will
arrange for the funds to be converted into U.S. dollars and for the distribution
of the U.S. dollars to the holders, subject to English laws and
regulations.
The
conversion into U.S. dollars will take place only if this can be done on a
reasonable basis, in the judgment of the depositary, and if the U.S. dollars are
transferable to the United States. The amounts distributed to holders
will be net of the fees, expenses, taxes and governmental charges payable by
holders under the terms of the deposit agreement. The depositary will
apply the same method for distributing the proceeds of the sale of any property,
such as undistributed rights, held by the custodian in respect of securities on
deposit.
Distributions of
Shares
Upon
receipt of a free distribution of Ordinary Shares or preference shares, the
depositary will either
distribute to holders new ADSs representing the Ordinary Shares or preference
shares deposited with the custodian or modify the ratio of ADSs
to Ordinary Shares or preference shares, in which case each ADS you hold will
represent rights and interests in the additional Ordinary Shares or preference
shares so deposited. Only whole new ADSs will be
distributed. Fractional entitlements will be sold and the proceeds of
such sale will be distributed as in the case of a cash
distribution.
The
distribution of new ADSs or the modification of the ratio of ADSs to Ordinary
Shares or preference shares upon a distribution of Ordinary Shares or preference
shares will be made net of the fees, expenses, taxes and governmental charges
payable by holders under the terms of the deposit agreement. In order
to pay such taxes or governmental charges, the depositary may sell all or a
portion of the new Ordinary Shares or preference shares so
distributed.
No such
distribution of new ADSs will be made if it would violate the U.S. securities
laws or other applicable law. If the depositary does not distribute
new ADSs or change the ADS-to-Ordinary Share ratio as described above, it may
sell the Ordinary Shares received and distribute the proceeds of the sale as in
the case of a distribution of cash.
Distributions of
Rights
In the
event that we distribute rights to purchase additional Ordinary Shares or
preference shares, the depositary will determine whether it is lawful and
feasible to distribute rights to purchase additional ADSs to
holders.
-53-
The
depositary will establish procedures to distribute rights to purchase additional
ADSs to holders and to enable such holders to exercise such rights if it is
lawful and feasible to make the rights available to holders of
ADSs. We may be required to provide certain documentation
contemplated in the deposit agreement, such as opinions to address the
lawfulness of the transaction. You may have to pay fees, expenses,
taxes and other governmental charges to subscribe for the new ADSs upon the
exercise of your rights.
The
depositary will not
distribute the rights to you if:
|
·
|
it
is not lawful or feasible to distribute the
rights;
|
|
·
|
we
fail to deliver satisfactory documents to the depositary;
or
|
|
·
|
it
appears that the rights are about to
lapse.
|
The
depositary will sell the rights that are not exercised or not distributed if
such sale is lawful and reasonably practicable. The proceeds of such
sale will be distributed to holders as in the case of a cash
distribution. If the depositary is unable to sell the rights, it will
allow the rights to lapse.
Other
Distributions
If we
distribute property other than cash, Ordinary Shares, rights to purchase
additional Ordinary Shares, preference shares or rights to purchase additional
preference shares and if we provide all of the documentation contemplated in the
applicable deposit agreement, the depositary will distribute the property to the
holders in a manner it deems equitable and practicable.
The
distribution will be made net of fees, expenses, taxes and governmental charges
payable by holders under the terms of the deposit agreement. In order
to pay such taxes and governmental charges, the depositary may sell all or a
portion of the property received.
If in the
opinion of the depositary a distribution is not feasible, it will not distribute the property
to you and may sell the property with our reasonable approval. The
depositary may deem a distribution not to be feasible if:
|
·
|
any
amounts are required to be withheld for taxes or governmental
charges;
|
|
·
|
any
obligations arise under applicable securities laws of exchange control
laws; or
|
|
·
|
there
is any requirement that distributable securities be registered under the
Securities Act or otherwise.
|
The
proceeds of such a sale will be distributed to holders as in the case of a cash
distribution.
Changes
Affecting Ordinary Shares and Preference Shares
The
Ordinary Shares or preference shares held on deposit for your ADSs may change
from time to time. For example, there may be a change in nominal or
par value, a split-up, cancellation, consolidation or reclassification of such
Ordinary Shares or preference shares or a recapitalization, reorganization,
merger, consolidation or sale of assets.
If any
such change were to occur, your ADSs would represent the right to receive the
property received or exchanged in respect of the Ordinary Shares or preference
shares held on deposit. The depositary may in such circumstances
deliver new ADSs to you or call for the exchange of your existing ADSs for new
ADSs. If the deposi-
-54-
tary may
not lawfully distribute such property to you, the depositary may sell such
property and distribute the net proceeds to you as in the case of a cash
distribution.
Issuance
of ADSs upon Deposit of Ordinary Shares or Preference Shares
The
depositary may create ADSs on your behalf if you or your broker deposits
Ordinary Shares or preferences shares with the custodian. The
depositary will deliver these ADSs to the person you indicate only after you pay
any applicable issuance fees and any charges and taxes payable for the transfer
of the Ordinary Shares or preference shares to the custodian. Your
ability to deposit Ordinary Shares or preference shares and receive ADSs may be
limited by U.S. and UK legal considerations applicable at the time of
deposit. Neither Ordinary Shares nor preference shares will be
accepted for deposit until the depositary receives evidence that there has been
compliance with English currency exchange regulations. The depositary
will only issue ADSs in whole numbers.
When you
make a deposit of Ordinary Shares or preference shares, you will be responsible
for transferring good and valid title to the depositary. As such, you
will be deemed to represent and warrant that:
|
·
|
the
Ordinary Shares or preference shares are validly issued, fully paid and
non-assessable;
|
|
·
|
all
preemptive rights, if any, with respect to such Ordinary Shares or
preference shares have been validly waived or
exercised;
|
|
·
|
you
are duly authorized to deposit the Ordinary Shares or preference shares,
as applicable; and
|
|
·
|
the
Ordinary Shares or preference shares presented for deposit have not been
stripped of any rights or
entitlements.
|
In
addition, unless you are depositing Ordinary Shares or preference shares in
exchange for ADSs that are restricted ADSs, you will also be deemed to represent
that the Ordinary Shares or preference shares presented for deposit are not
restricted securities as defined in the deposit agreement.
Withdrawal
of Shares upon Cancellation of ADSs
As a
holder, you will be entitled to present your ADSs to the depositary for
cancellation and then receive the corresponding number of underlying Ordinary
Shares or preference shares at the custodian’s offices. Your ability
to withdraw the Ordinary Shares or preference shares, as applicable, may be
limited by U.S. and U.K. legal considerations applicable at the time of
withdrawal. In order to withdraw the Ordinary Shares or preference
shares represented by your ADSs, you will be required to pay the depositary the
fees for cancellation of ADSs and any charges and taxes payable in connection
with the surrender and withdrawal. You assume the risk for delivery
of all funds and securities upon withdrawal. Once canceled, the ADSs
will not have any rights under the deposit agreement.
If you
hold an ADR registered in your name, the depositary may ask you to provide proof
of identity and genuineness of any signature and such other documents as the
depositary may deem appropriate before it will cancel your ADSs. The
withdrawal of the Ordinary Shares or preference shares represented by your ADSs
may be delayed until the depositary receives satisfactory evidence of compliance
with all applicable laws and regulations. Please keep in mind that
the depositary will only accept ADSs for cancellation that represent a whole
number of securities on deposit.
You will
have the right to withdraw the securities represented by your ADSs at any time
except for:
|
·
|
temporary
delays that may arise because (i) the transfer books for the Ordinary
Shares or preference shares, as applicable, or ADSs are closed, or
(ii) Ordinary Shares or preference shares are immobilized on account
of a shareholders’ meeting or a payment of
dividends;
|
|
·
|
obligations
to pay fees, taxes and similar charges would arise as a result of such
withdrawal; or
|
-55-
|
·
|
restrictions
may be imposed because of laws or regulations applicable to ADSs or the
withdrawal of securities on
deposit.
|
The
deposit agreement may not be modified to impair your right to withdraw the
securities represented by your ADSs.
Restricted
ADSs
Each
holder depositing Ordinary Shares that constitute “restricted securities” (as
defined in the deposit agreement) with the depositary will receive restricted
ADRs evidencing restricted ADSs pursuant to and in accordance with the letter
agreement between the depositary and us dated as of March 29, 2006 (the
“Restricted ADR Letter Agreement”). We entered into the Restricted
ADR Letter Agreement to, inter
alia, establish procedures for (i) the deposit of “restricted securities”
with the depositary, (ii) the issuance by the depositary of restricted ADRs
representing restricted ADSs related to such restricted securities and (iii) the
transfer or exchange of interests in the restricted ADSs, including the
certifications and other requirements that will be required to affect such
transactions under various circumstances.
Restricted
ADRs will be issued in certificated form with a restrictive legend and may only
be transferred or exchanged in accordance with the Restricted ADR Letter
Agreement. Except as set forth in the Restricted ADR Letter Agreement
and except as required by applicable law, restricted ADRs will have the same
rights and obligations and will be treated as ADRs that are not “restricted
ADRs” for all other purposes. Restricted ADRs may not be transferred
except pursuant to an effective registration statement under the Securities Act
or an available exemption from the registration requirements of the Securities
Act.
Voting
Rights
As a
holder of ADSs representing Ordinary Shares, you generally have the right under
the deposit agreement to instruct the depositary to exercise the voting rights
for the Ordinary Shares represented by your ADSs. The voting rights
of holders of Ordinary Shares are described under the heading “Description of
Ordinary Shares” in our 2008 Annual Report. Holders of ADSs
representing preference shares will generally have the right to instruct the
depositary to exercise the voting rights for the preference shares represented
by their ADSs. Holders of any series of preference shares will have
voting rights, if any, fixed by our Board of Directors and described in the
prospectus supplement relating to such series of preference
shares. Our articles of association and English law provide that the
holders of any series 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 such series of
preference shares.
The
depositary will mail to you any notice of shareholders’ meetings received from
us, together with a statement that holders will be entitled to instruct the
depositary to exercise the voting rights of the securities represented by ADSs,
and information explaining how to give such instructions.
If the
depositary timely receives voting instructions from a holder of ADSs, it will
endeavor to vote the securities represented by the holder’s ADSs in accordance
with such voting instructions and the terms of the deposit
agreement.
If poll
voting is duly demanded and no instructions are received, the depositary will
deem the holders to have granted a discretionary proxy to the person designated
by us, unless we request otherwise. However, no discretionary proxy
will be deemed granted for any proposition that:
|
·
|
involves
the solicitation of opposing proxies or other substantial opposition;
or
|
-56-
|
·
|
authorizes
a merger, consolidation or other matter that may materially affect the
rights and privileges of holders.
|
The
depositary has agreed to appoint one or more representatives to vote at
shareholders’ meetings either on a show of hands or a poll. In
general, proxies may be voted only if a vote on a poll is duly
demanded. See “Description of Ordinary Shares—Voting Rights” of our
2008 Annual Report. The depositary will not join in demanding a vote
on a poll unless instructed by at least two holders of ADSs or holders of ADSs
owning at least 10% of the voting interests of all holders having the right to
vote at such meeting. If a poll is not demanded, the depositary shall
follow the instructions of a majority in interest of the holders of ADSs who
have instructed the depositary to vote.
Please
note that the ability of the depositary to carry out voting instructions may be
limited by practical and legal limitations, the terms of our memorandum and
articles of association, and the terms of the securities on
deposit. We cannot assure you that you will receive voting materials
in time to enable you to return voting instructions to the depositary in a
timely manner.
Fees
and Charges
As an ADS
holder, under the deposit agreement you will be required to pay the following
service fees to the depositary:
|
Service
|
Fees
|
|
Issuance
of ADSs
|
Up
to 5¢ per ADS issued (or portion thereof)
|
|
Cancellation/Surrender
of ADSs
|
Up
to 5¢ per ADS canceled (or portion
thereof)
|
However,
pursuant to a letter agreement we entered into with the depositary as of March
21, 2005, the depositary has agreed to (i) waive the fees indicated above
relating to the issuance of ADSs in lieu of an annual maintenance fee payable by
us and (ii) reduce the cancellation/surrender fees indicated above to the
following fees depending upon the price of the ADSs then-quoted on
Nasdaq:
|
ADS price on Nasdaq
|
Cancellation/Surrender Fee per
ADS
|
|
$0.00
- $5.00
|
1.5¢
|
|
$5.01
- $10.00
|
2.0¢
|
|
$10.01
and above
|
3.0¢
|
This
letter agreement and the fee waivers and reductions contained in the letter
agreement may be terminated under certain circumstances by the
depositary.
As an ADS
holder you will also be responsible to pay certain fees and expenses incurred by
the depositary and certain taxes and governmental charges such as:
|
·
|
fees
for the transfer and registration of Ordinary Shares or preference shares
charged by the registrar and transfer agent for the Ordinary Shares or
preference shares in England (i.e., upon deposit and
withdrawal of Ordinary Shares or preference
shares);
|
|
·
|
expenses
incurred for converting foreign currency into U.S.
dollars;
|
|
·
|
expenses
for cable, telex and fax transmissions and for delivery of securities;
and
|
-57-
|
·
|
taxes
and duties upon the transfer of securities (i.e., when Ordinary
Shares or preference shares are deposited or withdrawn from
deposit).
|
We have
agreed to pay certain other charges and expenses of the
depositary. Note that the fees and charges you may be required to pay
may vary over time and, as with the letter agreement of March 31, 2005, may be
changed by us and by the depositary. You will receive prior notice of
such changes.
Amendments
and Termination
We may
agree with the depositary to modify the applicable deposit agreement at any time
without your consent. We undertake to give holders three months’
prior notice of any modifications that would prejudice any substantial rights of
the holders under the deposit agreement. We will not consider to be
prejudicial to your substantial rights any modifications or supplements that are
reasonably necessary for the ADSs to be registered under the Securities Act or
to be eligible for book-entry settlement, in each case without imposing or
increasing the fees and charges you are required to pay.
You will
be bound by the modifications to the applicable deposit agreement if you
continue to hold your ADSs after the modifications to the deposit agreement
become effective. The applicable deposit agreement cannot be amended
to prevent you from withdrawing the Ordinary Shares or preference shares
represented by your ADSs.
We have
the right to direct the depositary to terminate the deposit
agreement. Similarly, the depositary may in certain circumstances on
its own initiative terminate the deposit agreement. In either case,
the depositary must give notice to the holders at least 30 days before
termination.
Upon
termination of the applicable deposit agreement, withdrawal of the Ordinary
Shares or preference shares and distributions to holders will occur as described
below.
|
·
|
For
a period of six months after termination, you will be able to request the
cancellation of your ADSs and the withdrawal of the Ordinary Shares or
preference shares represented by your ADSs and the delivery of all other
property held by the depositary in respect of those Ordinary Shares or
preference shares on the same terms as prior to the
termination. During such six-month period the depositary will
continue to collect all distributions received on the Ordinary Shares or
preference shares on deposit (i.e., dividends) but
will not distribute any such property to you until you request the
cancellation of your ADSs.
|
|
·
|
After
the expiration of such six-month period, the depositary may sell the
securities held on deposit. The depositary will hold the
proceeds from such sale and any other funds then held for the holders of
ADSs in a non-interest bearing account. At that point, the
depositary will have no further obligations to holders other than to
account for the funds then held for the holders of ADSs still
outstanding.
|
Books
of Depositary
The
depositary will maintain ADS holder records at its depositary
office. You may inspect such records at such office at reasonable
times, but solely for the purpose of communicating with other holders in the
interest of business matters of our company or relating to the ADSs or the
deposit agreement.
The
depositary will maintain facilities in New York City to record and process the
execution, delivery, registration, transfer and surrender of
ADRs. These facilities may be closed from time to time when deemed
expedient by the depositary, or at our request.
-58-
Limitations
on Obligations and Liabilities
The
deposit agreement limits our obligations and the depositary’s obligations to
you. Please note the following:
|
·
|
we
and the depositary are obligated only to use our best judgment and good
faith in performing the duties specifically stated in the deposit
agreement without negligence or bad
faith;
|
|
·
|
the
depositary disclaims any liability for any failure to carry out voting
instructions, for any manner in which a vote is cast or for the effect of
any vote, provided it acts in good
faith;
|
|
·
|
we
and the depositary will not be obligated to appear in, prosecute or defend
any lawsuit or other proceeding unless satisfactory indemnity is provided
against all expenses and liabilities;
and
|
|
·
|
we
and the depositary disclaim any liability for any action or inaction in
reliance on the advice or information received from legal counsel,
accountants, any person presenting Ordinary Shares for deposit, any holder
of ADRs, or any other person believed by either of us in good faith to be
competent to give such advice or
information.
|
Pre-Release
Transactions
The
depositary may, in certain circumstances, issue ADSs before receiving a deposit
of Ordinary Shares or preference shares or release Ordinary Shares or preference
shares before receiving ADSs. These transactions are commonly
referred to as “pre-release transactions.” The deposit agreement
limits the aggregate size of pre-release transactions and imposes a number of
conditions on such transactions, including the need to receive collateral, the
type of collateral required, the representations required from brokers,
etc. The depositary may retain the compensation received from the
pre-release transactions.
Taxes
You will
be responsible for the taxes and other governmental charges payable on the ADSs
and the securities represented by the ADSs. We, the depositary and
the custodian may deduct from any distribution the taxes and governmental
charges payable by holders and may sell any and all property on deposit to pay
the taxes and governmental charges payable by holders. You will be
liable for any deficiency if the sale proceeds do not cover the taxes that are
due.
The
depositary may refuse to issue ADSs, to deliver, transfer, split and combine
ADRs or to release securities on deposit until all taxes and charges are paid by
the applicable holder. The depositary and the custodian may take
reasonable administrative actions to obtain tax refunds and reduced tax
withholding for any distributions on your behalf. However, you may be
required to provide to the depositary and to the custodian proof of taxpayer
status and residence and such other information as the depositary and the
custodian may require to fulfill legal obligations. You are required
to indemnify us, the depositary and the custodian for any claims with respect to
taxes based on any tax benefit obtained for you.
Foreign
Currency Conversion
The
depositary will arrange for the conversion of all foreign currency received into
U.S. dollars if in its judgment conversion can be made on a reasonable
basis. The depositary will distribute the U.S. dollars in accordance
with the terms of the deposit agreement. You may have to pay fees and
expenses incurred in converting foreign currency, such as fees and expenses
incurred in complying with currency exchange controls and other governmental
requirements.
-59-
If the
depositary determines that the foreign currency is not convertible on a
reasonable basis, or if any required approvals are not obtainable or are not
obtained within a reasonable period, the depositary may take the following
actions in its discretion:
|
·
|
convert
the foreign currency to the extent practical and lawful and distribute the
U.S. dollars to the holders for whom the conversion and distribution is
lawful and practical;
|
|
·
|
distribute
the foreign currency to holders for whom the distribution is lawful and
practical; and
|
|
·
|
hold
the foreign currency for the applicable
holders.
|
FINANCIAL
STATEMENTS
Our
consolidated financial statements and other financial information on pages F-1
to F-69 of our 2008 Annual Report are incorporated by reference
herein.
Our
unaudited interim financial statements and other financial information for the
six months ended June 30, 2009 on Form 6-K filed with the Commission on
December 14, 2009 are incorporated by reference herein.
EXPERTS
The
financial statements of Amarin Corporation plc incorporated in this prospectus
by reference to the 2008 Annual Report have been so incorporated in reliance on
the report of PricewaterhouseCoopers, an independent registered public
accounting firm, given on the authority of said firm as experts in auditing and
accounting.
The
historical consolidated financial statements for each of the three fiscal years
in the period ended December 31, 2008 incorporated by reference in this
prospectus have been so incorporated in reliance on the report of
PricewaterhouseCoopers, an independent registered public accounting firm, given
on the authority of said firm as experts in auditing and
accounting.
With
respect to the unaudited condensed consolidated financial information of Amarin
Corporation plc as of and for the six months ended June 30, 2009, for the six
months ended June 30, 2008 incorporated by reference in this prospectus,
PricewaterhouseCoopers reported that they have applied limited procedures in
accordance with professional standards for a review of such
information. However, their separate report dated December 14, 2009
incorporated by reference in this prospectus states that they did not audit and
they do not express an opinion on the unaudited condensed consolidated financial
information. Accordingly, the degree of reliance on their report on
such information should be restricted in light of the limited nature of the
review procedure applied. PricewaterhouseCoopers is not subject to
the liability provision of Section 11 of the Securities Act for their report on
the unaudited condensed consolidated financial information because the report is
not a “report’’ or a “part’’ of the registration statement prepared or certified
by PricewaterhouseCoopers within the meaning of Sections 7 and 11 of the
Securities Act.
LEGAL
MATTERS
The
Company is represented by its U.S. counsel, Cahill Gordon & Reindel llp, with respect to
U.S. federal law matters. The validity of the Ordinary Shares offered
hereby has been passed upon by K&L Gates LLP (registered in
England).
ENFORCEABILITY
OF CIVIL LIABILITIES
We are a
public limited company incorporated in England and Wales. 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
-60-
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 in U.S. courts judgments obtained
in U.S. courts predicated upon the civil liability provisions of the federal
securities laws of the United States. We have been advised by our
English solicitors that there is doubt as to the enforceability in England, in
original actions or in actions for enforcement of judgments of U.S. courts, of
civil liabilities to the extent predicated upon the federal securities laws of
the United States.
DISCLOSURE
OF COMMISSION POSITION ON
INDEMNIFICATION
FOR SECURITIES ACT LIABILITIES
As
described in the registration statement of which this prospectus forms a part,
our articles of association and certain provisions of English law contain
provisions relating to the ability of our officers and directors to be
indemnified by us for costs, charges, expenses, losses and other liabilities
which are sustained or incurred in the performance of the officer’s or
director’s duties for us. Insofar as indemnification for liabilities
arising under the Securities Act may be permitted to our directors, officers and
controlling persons pursuant to the charter provision, by-law, contract,
arrangements, statute or otherwise, we acknowledge that in the opinion of the
Securities and Exchange Commission such indemnification is against public policy
as expressed in the Securities Act and is, therefore,
unenforceable.
-61-
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item
6.Indemnification of Directors
and Officers
Except as
hereinafter set forth, there is no provision of the Company’s 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.
Article 192
of the Company’s Articles of Association provides:
|
192
|
Subject
to the provisions of, and so far as may be permitted by and consistent
with, the Statutes but without prejudice to any indemnity to which he may
otherwise be entitled, every Director, Secretary and officer of the
Company and every director, secretary and officer of each Associated
Company shall be indemnified out of the assets of the Company
against:
|
|
(a)
|
any
liability incurred by or attaching to him in connection with any
negligence, default, breach of duty or breach of trust by him in relation
to the Company or any Associated Company other
than:
|
|
(i)
|
any
liability to the Company or any Associated Company; and
|
||
|
(ii)
|
any
liability incurred by him to pay a fine imposed in criminal proceedings or
a sum payable to a regulatory authority by way of a penalty in respect of
non-compliance with any requirement of a regulatory nature (however
arising); and
|
||
|
(iii)
|
any
liability incurred by him:
|
|
(A)
|
in
defending criminal proceedings in which he is
convicted;
|
|||
|
(B)
|
in
defending any civil proceedings brought by the Company, or an Associated
Company in which judgement is given against him;
|
|||
|
(C)
|
in
connection with the application made under sections 661(3) or (4) or
section 1157 of the 2006 Act (or until such time as such provisions come
into effect, sections 144(3) or (4) or section 727 of the 1985 Act) in
which the court refuses to grant him
relief,
|
where, in any case, the conviction,
judgement or refusal of relief (as the case may be) has become final,
and
|
(b)
|
any
other liability incurred by or attaching to him in the actual or purported
performance and/or discharge of his duties and/or the exercise or
purported exercise of his powers and/or otherwise in relation to or in
connection with his duties, powers or
office.
|
|
192.1
|
Subject
to the provisions of, and so far as may be permitted by and consistent
with, the Statutes, the Company
may:
|
|
(a)
|
provide
a Director of the Company or a director of an Associated Company with
funds to meet expenditure incurred or to be incurred by
him:
|
II-1
|
(i)
|
in
defending any criminal or civil proceedings in connection with any alleged
negligence, default, breach of duty or breach of trust by him in relation
to the Company or an Associated Company; or
|
||
|
(ii)
|
in
connection with an application for relief under the provisions referred to
in sections 661(3) or (4) or section 1157 of the 2006 Act (or until such
time as such provisions come into effect sections 144(3) or (4) or section
727 of the 1985 Act); and
|
|
(b)
|
do
anything to enable him to avoid incurring such expenditure, provided
always that any loan made or liability incurred under any transaction
connected with anything done pursuant to this Article 192.1 shall be
repaid or (as the case may be) discharged in the event of such director
being convicted or judgement being given against him in the proceedings or
the court refusing to grant him relief on the application and by not later
than the date:
|
|
(i)
|
when
the conviction becomes final; or
|
||
|
(ii)
|
the
date when the judgement becomes final; or
|
||
|
(iii)
|
the
date when the refusal of relief becomes
final.
|
|
192.2
|
Subject
to the provisions of, and far as may be permitted by and consistent with,
the Statutes, the Company may:
|
|
(a)
|
provide
a Director of the Company or a director of an Associated Company with
funds to meet expenditure incurred or to be incurred by him in defending
himself in an investigation by a regulatory authority or against action
proposed to be taken by a regulatory authority in connection with any
alleged negligence, default, breach of duty or breach of trust by him in
relation to the Company or any Associated Company; and
|
|
|
(b)
|
do
anything to enable him to avoid incurring such
expenditure.
|
|
192.3
|
Subject
to the provisions of, and so far as may be permitted by and consistent
with, the Statutes but without prejudice to any indemnity to which he may
otherwise be entitled, every director of any Trustee Company shall be
indemnified out of the assets of the Company against any liability
incurred in connection with the activities of the Trustee Company as a
trustee of any occupational pension scheme of which it is a trustee other
than any liability of the kind referred to in section 235(3) of the 2006
Act. For the purposes of this Article
192.3:
|
|
(a)
|
"Trustee
Company" means a company (being the Company or an Associated Company) that
is a trustee of an occupational pension scheme; and
|
|
|
(b)
|
"occupational
pension scheme" means an occupational pension scheme as defined in section
150(5) of the Finance Act 2004 that is established under a
trust.
|
|
192.4
|
For
the purposes of Article 192:
|
|
(a)
|
"Associated
Company" means a company which is associated with the Company within the
meaning of section 256 of the 2006
Act;
|
II-2
|
(b)
|
where
a director is indemnified against any liability, such indemnity shall
extend to all costs, charges, losses, expenses and liabilities incurred by
him in relation thereto;
|
|
|
(c)
|
a
conviction, judgement, or refusal of relief becomes final
if:
|
|
(i)
|
not
appealed against, at the end of the period for bringing an appeal;
or
|
||
|
(ii)
|
if
appealed against, at the time when the appeal (or any further appeal) is
disposed of; and
|
|
(d)
|
an
appeal is disposed of if:
|
|
(i)
|
it
is determined and the period for brining any further appeal has ended;
or
|
||
|
(ii)
|
if
it is abandoned or otherwise ceases to have
effect.
|
In
addition, U.K. companies can obtain liability insurance for directors and can
also pay directors’ legal costs if they are successful in defending legal
proceedings.
The
Company has entered into deeds of indemnification with directors or formers
directors including William Hall, Srinivas Akkaraju, Dr. John Climax, James
Healy, Dr. Bill Mason, Dr. Simon Kukes, Dr. Michael Walsh, Manus Rogan, Rick
Stewart, Eric Aguiar, Carl Gordon, Lars Ekman, Thomas Lynch, Anthony
Russell-Roberts and Dr. Joseph Anderson. The Company has entered into
deeds of indemnification with officers, former officers or members of senior
management including Conor Dalton, Dr. Declan Doogan, Paul Duffy, John Thero,
Alan Cooke, Tom Maher and Paresh Soni.
Insofar
as indemnification for liabilities arising under the Securities Act 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.
Item
7.Recent Sale of Unregistered
Securities
On
October 16, 2009, in connection with the 2009 Private Placement, Amarin issued
units to several existing and new institutional and accredited investors for an
aggregate consideration of $70 million, consisting of $66.4 million in cash
proceeds and $3.6 million from the conversion of convertible bridge
notes. On the closing of the 2009 Private Placement, in consideration
for the $66.4 million received in cash, Amarin issued 66.4 million
units. Each unit had a purchase price of $1.00 and consisted of one
ADS and one 2009 Warrant to purchase 0.50 of an ADS. The 2009
Warrants have a five year term and an exercise price of $1.50 per
ADS. The holders of $3.6 million convertible bridge loan notes
converted their principal into units and the accrued interest was repaid in
cash. In accordance with the terms of the conversion of the bridge notes, each
unit had a purchase price of $0.90 and consisted of one ADS and one 2009
Warrant. As a result, the Company issued 3,999,996 Ordinary Shares
and 2009 Warrants to purchase 1,999,996 shares with an exercise price of
$1.50. The 2009 Private Placement was exempt under Rule 506 of
Regulation D promulgated under the Securities Act. The proceeds of
the offering are to be used to advance Amarin’s cardiovascular disease programs
and related overhead costs. Cowen and Company, LLC and Niki Dilger
acted as the placement agent and an advisor, respectively, in the
transaction.
At
closing of the 2009 Private Placement, the non-executive directors Dr. John
Climax, Dr. Bill Mason and Mr. Anthony Russell Roberts resigned as
directors. Such directors were each granted 5,000 stock options per year of
service which vested in full on closing. Since the 2009 Private
Placement, the Company issued to certain executives
II-3
of Amarin
warrants (the “Executive Warrants”), having substantially the same terms as the
2009 Warrants, to purchase an aggregate amount of 904,005 Ordinary
Shares. In addition, the Company has issued or agreed to issue the
options and warrants to certain directors and officers described above in
“Financial Information—Significant Changes—Changes in Directors, Officers and
Board Committees.” All of such securities were issued in reliance upon the
exemption from the registration requirements of the Securities Act afforded by
Section 4(2) thereof and/or Regulation S promulgated thereunder.
In June
2009, Amarin announced that it had amended the Ester Neurosciences Limited
(“Ester”) acquisition agreement entered into in December 2007. The
amendments, which reflect Amarin’s intention to seek a partner for EN101,
provide for the release of Amarin from research and development diligence
obligations contained in the original agreement, with remaining contingent
milestones only being payable from fees and milestones received from any future
partners. In connection with the amendment and waiver agreement,
Amarin issued 1,355,262 Ordinary Shares. Such securities were issued
in reliance upon the exemption from the registration requirements of the
Securities Act afforded by Regulation S promulgated thereunder.
In May
2009, Amarin announced that it entered into definitive agreements with certain
existing investors in the Company, including a number of directors of the
Company, for the Initial Bridge Financing, consisting of convertible bridge loan
notes in the amount of $2.6 million. In July 2009, $0.1 million of
the Initial Bridge Financing was repaid. In August 2009, the date of
maturity on the convertible loans was extended to September 30,
2009. In August 2009, Amarin announced that it had entered into
definitive agreements with certain existing investors in the Company, including
a number of directors of the Company, for the Additional Bridge Financing,
consisting of convertible bridge loan notes in the amount of $3.0
million.
The
Initial Bridge Financing and Additional Bridge Financing consist of convertible
notes and Bridge Warrants to purchase 3,111,105 shares with an exercise price of
$1.00. The aggregate convertible notes were in the principal amount
of $5.5 million, were to mature on September 30, 2009 and pay interest at the
rate of 8% per annum. In September 2009, the date of maturity was
extended to October 16, 2009. The Bridge Warrants are in addition to
the 2009 Warrants that were issued on conversion of the convertible bridge loan
notes described above. Such securities were issued in reliance upon
the exemption from the registration requirements of the Securities Act afforded
by Section 4(2) thereof and/or Regulation S promulgated
thereunder. The proceeds of the Initial Bridge Financing and
Additional Bridge Financing were used for operating expenses of the
Company.
On May
16, 2008, pursuant to the May 2008 Financing, Amarin raised gross proceeds of
$30,000,000 in a private placement of 13,043,479 Ordinary Shares at a share
price of $2.30 per Ordinary Share. Such securities were issued in
reliance upon the exemption from the registration requirements of the Securities
Act afforded by Section 4(2) thereof and/or Regulation S promulgated
thereunder. The proceeds of that offering were used to advance
Amarin’s cardiovascular disease programs and other research and development
programs of the Company. Cowen and Company, LLC and Rodman &
Renshaw LLC acted as the placement agents in the transaction.
Item
8.Exhibits
Exhibits
filed as part of this registration statement:
|
1.1
|
Memorandum
of Association of the Group(16)
|
|
1.2
|
Articles
of Association of the Group(17)
|
|
2.1
|
Deposit
Agreement, dated as of March 29, 1993, among the Group, 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 Group,
Citibank, N.A., as Depositary, and all holders from time to time of the
American Depositary Receipts issued
thereunder(2)
|
II-4
|
2.3
|
Amendment
No. 2 to Deposit Agreement, dated as of September 25, 2002 among the
Group, 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
(25)
|
|
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 Group, 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 Group and the
Purchasers named therein(4)
|
|
2.10
|
Registration
Rights Agreement, dated as of November 24, 2000, by and between the Group
and Laxdale Limited(5)
|
|
2.11
|
Form
of Subscription Agreement, dated as of January 27, 2003 by and among the
Group and the Purchasers named therein(10) (The Group 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
Group and the Purchasers named therein(10) (The Group 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 Group
and the purchasers named
therein(16)
|
|
4.1
|
Amended
and Restated Asset Purchase Agreement dated September 29, 1999 between
Elan Pharmaceuticals Inc. and the
Group(10)
|
|
4.2
|
Variation
Agreement, undated, between Elan Pharmaceuticals Inc. and the
Group(10)
|
|
4.3
|
License
Agreement, dated November 24, 2000, between the Group and Laxdale
Limited(6)
|
|
4.4
|
Option
Agreement, dated as of June 18, 2001, between Elan Pharma International
Limited and the Group(7)
|
|
4.5
|
Deed
of Variation, dated January 27, 2003, between Elan Pharma International
Limited and the Group(10)
|
|
4.6
|
Lease,
dated August 6, 2001, between the Group 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
Group(8)
|
II-5
|
4.8
|
Amended
and Restated License and Supply Agreement, dated March 29, 2002, between
Eli Lilly and Group(10)†
|
|
4.9
|
Deed
of Variation, dated January 27, 2003, between Elan Pharmaceuticals Inc.
and the Group(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 Group(7)
|
|
4.11
|
Stock
Purchase Agreement, dated November 30, 2001, by and among Abriway
International S.A., Beta Pharmaceuticals Corporation and the
Group(7)
|
|
4.12
|
Novation
Agreement, dated November 30, 2001, by and among Beta Pharmaceuticals
Corporation, Amarin Technologies S.A. and the
Group(7)
|
|
4.13
|
Loan
Agreement, dated September 28, 2001, between Elan Pharma International
Limited and the Group(8)
|
|
4.14
|
Deed
of Variation, dated July 19, 2003, amending certain provisions of the Loan
Agreement between the Group and Elan Pharma International
Limited(10)
|
|
4.15
|
Deed
of Variation No. 2, dated December 23, 2002, between The Group and Elan
Pharma International Limited(10)
|
|
4.16
|
Deed
of Variation No. 3, dated January 27, 2003, between the Group and Elan
Pharma International Limited(10)
|
|
4.17
|
The
Group 2002 Stock Option Plan(17)
|
|
4.18
|
Agreement
Letter, dated October 21, 2002, between the Group and Security Research
Associates, Inc.(10)
|
|
4.19
|
Agreement,
dated January 27, 2003, among the Group, 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
Group(10)
|
|
4.21
|
Form
of Warrant Agreement, dated March 19, 2003, between the Group and
individuals designated by Security Research Associates,
Inc.(10) (The Group 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
Group(10)†
|
|
4.23
|
Share
Subscription and Purchase Agreement dated October 28, 2003 among the
Group, 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 Group, Amarin
Pharmaceuticals Company Limited and Valeant Pharmaceuticals
International(12)†
|
II-6
|
4.25
|
Amendment
No. 1 to Asset Purchase Agreement dated February 25, 2004 between the
Group, Amarin Pharmaceuticals Company Limited and Valeant Pharmaceuticals
International(12)
|
|
4.26
|
Development
Agreement dated February 25, 2004 between the Group 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
Group(12)
|
|
4.28
|
Debenture
dated August 4, 2003 made by the Group in favor of Elan Corporation plc as
Trustee(12)
|
|
4.29
|
Debenture
Amendment Agreement dated December 23, 2003 between the Group and Elan
Corporation plc as Trustee(12)
|
|
4.30
|
Debenture
Amendment Agreement No. 2 dated February 24, 2004 between the Group 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 Group
(11)(12)
|
|
4.33
|
Amended
and Restated Option Agreement dated August 4, 2003 between the Group 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 Group(11)(12)
|
|
4.35
|
Deed
of Variation No. 4, dated August 4, 2003, to Loan Agreement between the
Group 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
Group(11)(12)
|
|
4.37
|
Warrant
dated February 25, 2004 issued by the Group 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 Group(11)(12)
|
|
4.39
|
Bridging
Loan Agreement dated December 23, 2003 between the Group and Elan
Pharmaceuticals, Inc.(11)(12)
|
|
4.40
|
Agreement
dated December 23, 2003 between the Group and Elan Pharma International
Limited, amending the Amended and Restated Option Agreement dated August
4, 2003(11)(12)
|
|
4.41
|
Form
of Subscription Agreement, dated as of October 7, 2004 by and among the
Group and the Purchasers named therein(13) (The Group entered
into 14 separate Subscription Agreements on October 7, 2004 all
substantially similar in form and content to this form of Subscription
Agreement.)
|
II-7
|
4.42
|
Form
of Registration Rights Agreement, dated as of October 7, 2004 between the
Group and the Purchasers named therein(13) (The Group 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.)
|
|
4.43
|
Share
Purchase Agreement dated October 8, 2004 between the Group, Vida Capital
Partners Limited and the Vendors named therein relating to the entire
issued share capital of Laxdale
Limited(13)
|
|
4.44
|
Escrow
Agreement dated October 8, 2004 among the Group, Belsay Limited and
Simcocks Trust Limited as escrow
agent(13)
|
|
4.45
|
Loan
Note Redemption Agreement dated October 14, 2004 between Amarin Investment
Holding Limited and the Group(13)
|
|
4.46
|
Settlement
agreement dated 27 September 2004 between the Group and Valeant
Pharmaceuticals International(14)†
|
|
4.47
|
Exclusive
License Agreement dated October 8, 2004 between Laxdale and Scarista
Limited pursuant to which Scarista has the exclusive right to use certain
of Laxdale’s intellectual
property(14)†
|
|
4.48
|
Clinical
Supply Agreement between Laxdale and Nisshin Flour Milling Co., Limited
dated 27th October 1999(14)†
|
|
4.49
|
Loan
Note Redemption Agreement dated May, 2005 between Amarin Investment
Holding Limited and the Group(14)
|
|
4.50
|
Services
Agreement dated June 16, 2005 between Icon Clinical Research Limited and
Amarin Neuroscience Limited(15)
|
|
4.51
|
Employment
Agreement with Alan Cooke, dated May 12, 2004 and amended September 1,
2005(16)
|
|
4.52
|
Clinical
Supply Extension Agreement dated December 13, 2005 to Agreement between
Amarin Pharmaceuticals Ireland Limited and Amarin Neuroscience Limited and
Nisshin Flour Milling Co.†(17)
|
|
4.53
|
Securities
Purchase Agreement dated May 20, 2005 between the Company and the
purchasers named therein. The Company entered into 34 separate
Securities Purchase Agreements on May 18, 2005 and in total issued
13,677,110 ordinary shares to management, institutional and accredited
investors. The purchase price was $1.30 per ordinary
share(17).
|
|
4.54
|
Securities
Purchase Agreement dated January 23, 2006 between the Company and the
purchasers named therein. The Company entered into 2 separate
Securities Purchase Agreements on January 23, 2006 and in total issued
840,000 ordinary shares to accredited investors. The purchase
price was $2.50 per ordinary
share(17).
|
|
4.55
|
Assignment
Agreement dated May 17, 2006 between Amarin Pharmaceuticals Ireland
Limited and Dr Anthony Clarke, pursuant to which, Amarin Pharmaceuticals
Ireland Limited acquired the global rights to a novel oral formulation of
Apomorphine for the treatment of “off” episodes in patients with advanced
Parkinson’s disease(17)
|
|
4.56
|
Amendment
(Change Order Number 2), dated June 8, 2006 to Services Agreement dated
June 16, 2005 between Icon Clinical Research Limited and Amarin
Neuroscience Limited(23)
|
II-8
|
4.57
|
Securities
Purchase Agreement dated October 18, 2006 between the Company and the
purchasers named therein. The Company entered into 32 separate
Securities Purchase Agreements on October 18, 2006 and in total issued
8,965,600 ordinary shares to institutional and accredited
investors. The purchase price was $2.09 per ordinary
share(17).
|
|
4.58
|
Master
Services Agreement dated November 15, 2006 between Amarin Pharmaceuticals
Ireland Limited and Icon Clinical Research (U.K.)
Limited. Pursuant to this agreement, Icon Clinical Research
(U.K.) Limited agreed to provide due diligence services to Amarin
Pharmaceuticals Ireland Limited on ongoing licensing opportunities on an
ongoing basis.(17)
|
|
4.59
|
Agreement
dated January 18, 2007 between Neurostat Pharmaceuticals Inc.
(“Neurostat”), Amarin Pharmaceuticals Ireland Limited, Amarin Corporation
plc and Mr. Tim Lynch whereby the Company agreed to pay Neurostat a
finder’s fee relating to a potential licensing transaction and similar
payments comprising upfront and contingent milestones totaling $565,000
and warrants to purchase 175,000 ordinary shares with an exercise price of
$1.79 per ordinary share.(23)
|
|
4.60
|
Lease
Agreement dated January 22, 2007 between the Company, Amarin
Pharmaceuticals Ireland Limited and Mr. David Colgan, Mr. Philip Monaghan,
Mr. Finian McDonnell and Mr. Patrick Ryan. Pursuant to this
agreement, Amarin Pharmaceuticals Ireland Limited took a lease of a
premises at The First Floor, Block 2, The Oval, Shelbourne Road, Dublin 4,
Ireland(17).
|
|
4.61
|
Amendment
(Change Order Number 4), dated February 15, 2007 to Services Agreement
dated June 16, 2005 between Icon Clinical Research Limited and Amarin
Neuroscience Limited(17)
|
|
4.62
|
Employment
Agreement Amendment with Alan Cooke, dated February 21,
2007(17)
|
|
4.63
|
Amendment
(Change Order Number 3), dated March 1, 2007 to Services Agreement dated
June 16, 2005 between Icon Clinical Research Limited and Amarin
Neuroscience Limited(17)
|
|
4.64
|
Development
and License Agreement dated March 6, 2007 between Amarin Pharmaceuticals
Ireland Limited and Elan Pharma International Limited. Pursuant
to this agreement, Amarin Pharmaceuticals Ireland Limited acquired global
rights to a novel nasal lorazepam formulation for the treatment of
emergency seizures in epilepsy
patients(23)†
|
|
4.65
|
Consultancy
Agreement dated March 9, 2007 between Amarin Corporation plc and Dalriada
Limited. Under the Consultancy Agreement, Amarin Corporation
plc 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 our Chairman
and Chief Executive Officer, Mr. Thomas Lynch, and members of his
family(23)
|
|
4.66
|
Form
of Securities Purchase Agreement dated June 1, 2007 between Amarin
Corporation plc and the Purchasers named therein. Amarin
Corporation plc entered into 11 separate Securities Purchase Agreements on
June 1, 2007 all substantially similar in form and content to this
Securities Purchase Agreement pursuant to which we issued an aggregate of
6,156,406 ordinary shares to such Purchasers, including
management. The purchase price was $0.60 per ordinary
share(23).
|
|
4.67
|
Equity
Credit Agreement dated June 1, 2007 between Amarin Corporation plc and
Brittany Capital Management. Pursuant to this agreement, Amarin
has an option to draw up to $15,000,000 of funding at any time over a
three year period solely at Amarin Corporation plc’s
discretion(18)
|
|
4.68
|
Form
of Equity Securities Purchase Agreement dated December 4, 2007 between
Amarin Corporation plc and the Purchasers named therein. Amarin
Corporation plc entered into 19 separate Equity Securities
Pur-
|
II-9
chase
Agreements on December 4, 2007 all substantially similar in form and content to
this Equity Securities Purchase Agreement pursuant to which we issued an
aggregate of 16,290,900 ordinary shares to such Purchasers, including
management. The purchase price was $0.33 per ordinary
share(19).
|
4.69
|
Form
of Debt Securities Purchase Agreement dated December 4, 2007 between
Amarin Corporation plc and the Purchasers named therein. Amarin
Corporation plc entered into 2 separate Debt Securities Purchase
Agreements on December 4, 2007 both substantially similar in form and
content to this Debt Securities Purchase Agreement pursuant to which we
issued an aggregate of $2,750,000 of 3 year convertible loan notes to such
Purchasers including management. The conversion price to
convert the loan notes into ordinary shares of Amarin Corporation plc is
$0.48 per ordinary share(19)
|
|
4.70
|
Stock
Purchase Agreement dated December 5, 2007 between Amarin Corporation plc,
the selling shareholders of Ester Neurosciences Limited (“Ester”), Ester,
and Medica II Management L.P. pursuant to which Amarin Corporation plc
acquired the entire issued share capital of Ester. Pursuant to
this agreement, Amarin Corporation plc paid initial consideration of
$15,000,000, of which $5,000,000 was paid in cash and $10,000,000 was paid
through the issuance of shares of Amarin Corporation
plc. Additional contingent payments, valued at an aggregate of
$17,000,000 are payable in the event that certain development-based
milestones are successfully
completed(21)
|
|
4.71
|
Letter
Agreement dated December 6, 2007 between Amarin Corporation plc and the
Seller’s Representatives of the selling shareholders of Ester pursuant to
which the definition of “Closing Date Average Buyer Stock Price” in the
Stock Purchase Agreement dated December 5, 2007 described above was
amended(22)
|
|
4.72
|
Senior
Indenture dated December 6, 2007 between Amarin Corporation plc and
Wilmington Trust Company. Under this Indenture, Amarin
Corporation plc may issue one or more series of senior debt securities
from time to time(19).
|
|
4.73
|
First
Supplemental Senior Indenture Dated December 6, 2007 between Amarin
Corporation plc and Wilmington Trust Company. Under this
Supplemental Senior Indenture, together with the senior debt indenture
dated December 6, 2007 described above, Amarin Corporation plc issued its
8% Convertible Debentures due
2010(19).
|
|
4.74
|
Compromise
Agreement dated December 19, 2007 between Amarin Corporation plc and
Richard Stewart(20)
|
|
4.75
|
Collaboration
Agreement dated January 8, 2008 between Amarin Pharmaceuticals Ireland
Limited and ProSeed Capital Holdings (“ProSeed”). Pursuant to
this agreement, 975,000 ordinary shares in Amarin Corporation plc were
issued in the form of ADSs to ProSeed in respect of fees due for
investment banking advice provided to Amarin Corporation plc and Amarin
Pharmaceuticals Ireland Limited on the acquisition of
Ester(20)†
|
|
4.76
|
Amendment
No. 1 to Stock Purchase Agreement dated April 7, 2008 between Amarin
Corporation plc and Medica II Management L.P. pursuant to which the
definition of “Milestone II Time Limit Date” in the Stock Purchase
Agreement dated December 5, 2007 described above was
amended(23)
|
|
4.77
|
Employment
Agreement dated April 28, 2008 with Dr Declan
Doogan(20)
|
|
4.78
|
Form
of Equity Securities Purchase Agreement dated May 13, 2008 between Amarin
Corporation plc and the Purchasers named therein. Amarin
Corporation plc entered into 9 separate Equity Securities Purchase
Agreements on May 13, 2008 all substantially similar in form and content
to this Securities Purchase Agreement pursuant to which we issued an
aggregate of 12,173,914 Ordinary Shares and 8 Preference Shares to such
Purchasers. The purchase price was $2.30 per Ordinary
Share(20)†
|
II-10
|
4.79
|
Termination
and Separation Agreement and Release Agreement, dated August 7, 2008,
between Mr. Paul Duffy and Amarin Corporation
plc(23)
|
|
4.80
|
Directors
Securities Purchase Agreement dated May 13, 2008, among Sunninghill Ltd,
Simon Kukes, Michael Walsh and Amarin Corporation
plc(23)
|
|
4.81
|
Change
Order for Additional Biostatistics & Medical Writing Work dated June
04, 2008, between Icon Clinical Research Limited and Amarin Neuroscience
Limited(23)
|
|
4.82
|
Consultancy
Agreement, dated August 16, 2008, between Decisionability Inc and Amarin
Neuroscience Limited(23)
|
|
4.83
|
Master
Services Agreement, dated August 22, 2008, between Charles River
Laboratories Preclinical Services Edinburgh Limited, Amarin Neuroscience
Limited and Amarin Pharmaceuticals Ireland
Ltd(23)
|
|
4.84
|
Work
Order, dated September 3, 2008, between Charles River Laboratories
Preclinical Services Edinburgh Limited, Amarin Neuroscience Limited and
Amarin Pharmaceuticals Ireland
Ltd(23)
|
|
4.85
|
Consultancy
Agreement, dated October 10, 2008, between Icon Clinical Research Limited
and Amarin Corporation plc(23)
|
|
4.86
|
Supply
Agreement, dated February 23, 2009, between Nisshin Pharma Inc and Amarin
Pharmaceuticals Ireland Ltd(24)(†)
|
|
4.87
|
Trial
A Letter Agreement dated February 24, 2009 between Medpace Inc and Amarin
Pharma Inc and Amarin Pharmaceuticals Ireland
Ltd(23)
|
|
4.88
|
Amendment
and Waiver Agreement, dated May 25, 2009 between Ester Neurosciences Ltd.
Medica II Management L.P. and Amarin Corporation
plc(24)(†)
|
|
4.89
|
Amendment
number 2 to the Letter Agreement for certain initial services for certain
initial services for the Ethyl-EPA Hypertriglyceridemia Studies between
Medpace Inc and Amarin Pharma Inc and Amarin Pharmaceuticals Ireland Ltd
dated February 24, 2009, as amended on 5 May,
2009(23)
|
|
4.90
|
Termination
and Assignment Agreement, dated 21 July, 2009 between Elan Pharma
International Limited and Amarin Pharmaceuticals Ireland
Ltd(23)(†)
|
|
4.91
|
Amendment
number 5 to the Letter Agreement for certain initial services for certain
initial services for the Ethyl-EPA Hypertriglyceridemia Studies between
Medpace Inc and Amarin Pharma Inc and Amarin Pharmaceuticals Ireland Ltd
dated 1 December, 2008, as amended on 19 January, 2009, as further amended
30 January 2009, 5 May, 2009 and 3 August,
2009(23)
|
|
4.92
|
Master
Services Agreement, dated September 29, 2009, between Medpace Inc and
Amarin Pharma Inc and Amarin Pharmaceuticals Ireland
Ltd(23)
|
|
4.93
|
Bridge
Loan Agreement, dated July 31, 2009 between Sunninghill Ltd, Thomas G.
Lynch, Simon Kukes, Michael Walsh, Midsummer Investments Limited,
Midsummer Ventures LP, David Hurley, David Brabazon, Pram Lachman and
Amarin Corporation plc. as amended by Amendment No.1 dated September 30,
2009(23)
|
|
4.94
|
Securities
Purchase Agreement dated October 12, 2009 between Amarin Corporation plc
and the Purchasers named
therein(23)
|
II-11
|
4.95
|
Compromise
Agreement dated October 16, 2009 with Alan
Cooke(23)
|
|
4.96
|
Warrant
agreement for Thomas G. Lynch to subscribe for and purchase 500,000
Ordinary Shares of £0.50 each in Amarin Corporation plc with an exercise
price of $1.50(23)
|
|
4.97
|
Amendment
Agreement dated October 12, 2009, to the Form of Equity Securities
Purchase Agreement dated May 13, 2008 between Amarin Corporation plc and
the Purchasers named therein(23)
|
|
4.98
|
Letter
of Termination to William Mason dated October 9,
2009(27)
|
|
4.99
|
Letter
of Termination to Anthony Russell-Roberts dated October 9,
2009(27)
|
|
4.100
|
Letter
of Termination to John Climax dated October 9,
2009(27)
|
|
4.101
|
Letter
agreement dated October 12, 2009 with Dr. Declan
Doogan(27)
|
|
4.102
|
Letter
agreement dated October 12, 2009 with Joseph S.
Zakrzewski(27)
|
|
4.103
|
Letter
agreement dated October 16, 2009 with Thomas G.
Lynch(27)
|
|
4.104
|
Employment
Agreement dated November 5, 2009 with John F.
Thero(27)
|
|
4.105
|
Amendment
No. 1 to Securities Purchase Agreement dated December 2,
2009(27)
|
|
4.106
|
Letter
agreement dated December 9, 2009 with Thomas G. Lynch, Alan Cooke and Tom
Maher(27)
|
|
4.107
|
Compromise
Agreement dated December 10, 2009 with Tom
Maher(26)
|
|
5.1
|
Opinion
of K&L Gates LLP(27)
|
|
8.1
|
Subsidiaries
of the Group(23)
|
|
11.1
|
Code
of Ethics(17)
|
|
12.1
|
Certification
of Thomas G. Lynch 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(23)
|
|
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(23)
|
|
13.1
|
Certification
of Thomas G. Lynch 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(23)
|
|
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(23)
|
|
15.1
|
Awareness
Letter of PricewaterhouseCoopers*
|
|
23.1
|
Consent
of PricewaterhouseCoopers*
|
|
(1)
|
Incorporated
herein by reference to certain exhibits to the Group’s Registration
Statement on Form F–1, File No. 33–58160, filed with the Securities and
Exchange Commission on February 11,
1993.
|
II-12
|
(2)
|
Incorporated
herein by reference to Exhibit (a)(i) to the Group’s 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 Group’s Registration
Statement on Form F–6, File No. 333–147660, filed with the Securities and
Exchange Commission on November 28,
2007.
|
|
(4)
|
Incorporated
herein by reference to certain exhibits to the Group’s 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 Group’s 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 Group’s 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 Group’s 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 Group’s 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 Group’s 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 Group’s Annual Report on
Form 20-F for the year ended December 21, 2002, filed with the Securities
and Exchange Commission on April 24,
2003.
|
|
(11)
|
These
agreements are not longer in effect as a result of superseding agreements
entered into by the Group.
|
|
(12)
|
Incorporated
herein by reference to certain exhibits to the Group’s 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 Group’s Registration
Statement on Form F-3, File No. 333–121421, filed with the Securities and
Exchange Commission on December 20,
2004.
|
|
(14)
|
Incorporated
herein by reference to certain exhibits to the Group’s 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 Group’s 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 Group’s Annual Report on
Form 20–F for year ended December 31, 2005, filed with the Securities and
Exchange Commission on March 30, 2006 as amended on Form 20–F/A filed
October 13, 2006.
|
|
(17)
|
Incorporated
by reference herein to certain Exhibits in the Group’s Annual Report on
Form 20–F for the year ended December 31, 2006, filed with the Securities
and Exchange Commission on March 5,
2007.
|
|
(18)
|
Incorporated
by reference herein to certain exhibits in the Group’s Report of Foreign
Private Issuer filed on Form 6–K with the Securities and Exchange
Commission on June 1, 2007.
|
II-13
|
(19)
|
Incorporated
by reference herein to certain exhibits in the Group’s Report of Foreign
Private Issuer filed on Form 6–K with the Securities and Exchange
Commission on December 17, 2007.
|
|
(20)
|
Incorporated
by reference herein to certain exhibits in the Group’s Report of Foreign
Private Issuer filed on Form 6–K with the Securities and Exchange
Commission on December 19, 2007, as amended on Form 20-F/A filed September
24, 2008.
|
|
(21)
|
Incorporated
by reference herein to certain exhibits in the Group’s Report of Foreign
Private Issuer filed on Form 6–K with the Securities and Exchange
Commission on January 28, 2008.
|
|
(22)
|
Incorporated
by reference herein to certain exhibits in the Group’s Report of Foreign
Private Issuer filed on Form 6–K with the Securities and Exchange
Commission on February 1, 2008.
|
|
(23)
|
Incorporated
by reference herein to certain Exhibits in the Group’s Annual Report on
Form 20–F for the year ended December 31, 2008, filed with the Securities
and Exchange Commission on October 22,
2009.
|
|
(24)
|
Incorporated
by reference herein to certain Exhibits in Amendment No. 1 to the Group’s
2008 Annual Report on Form 20–F/A, filed with the Securities and Exchange
Commission on December 4, 2009.
|
|
(25)
|
Incorporated
by reference to Exhibit (a)(i) to the Group’s Registration Statement on
Form F-6, File No. 333-147660 filed with the Securities and Exchange
Commission on November 28, 2007.
|
|
(26)
|
Incorporated
by reference herein to certain exhibits in the Group’s Report of Foreign
Private Issuer filed on Form 6–K with the Securities and Exchange
Commission on December 14, 2009.
|
|
(27)
|
Incorporated
by reference herein to certain exhibits in the Group’s Registration
Statement on Form F-1, File No. 333-163704, filed with the Securities and
Exchange Commission on December 14, 2009.
|
|
|
* Filed
herewith
|
|
|
† Confidential
treatment requested (the confidential potions of such exhibits have been
omitted and filed separately with the Securities and Exchange
Commission).
|
Item
9.Undertakings
The
undersigned registrant hereby undertakes:
(1) To
file, during any period in which offers or sales are being made, a
post-effective amendment to this registration statement:
(i) To
include any prospectus required by section 10(a)(3) of the Securities Act
of 1933;
(ii) To
reflect in the prospectus any facts or events arising after the effective date
of the registration statement (or the most recent post-effective amendment
thereof) which, individually or in the aggregate, represent a fundamental change
in the information set forth in the registration
statement. Notwithstanding the foregoing, any increase or decrease in
volume of securities offered (if the total dollar value of securities offered
would not exceed that which was registered) and any deviation from the low or
high end of the estimated maximum offering range may be reflected in the form of
prospectus filed with the Commission pursuant to Rule 424(b) if, in the
aggregate, the changes in volume and price represent no more than a 20% change
in the maximum aggregate offering price set forth in the “Calculation of
Registration Fee” table in the effective registration statement;
(iii) To
include any material information with respect to the plan of distribution not
previously disclosed in the registration statement or any material change to
such information in the registration statement.
II-14
(2) That,
for the purpose of determining any liability under the Securities Act of 1933,
each such post-effective amendment shall be deemed to be a new registration
statement relating to the securities offered therein, and the offering of such
securities at the time shall be deemed to be the initial bona fide offering
thereof.
(3) To
remove from registration by means of a post-effective amendment any of the
securities being registered which remain unsold at the termination of the
offering.
(4) If
the registrant is a foreign private issuer, to file a post-effective
amendment to the registration statement to include any financial statements
required by § 210.3-19 of this chapter at the start of any delayed offering
or throughout a continuous offering. Financial statements and
information otherwise required by Section 10(a)(3) of the Act need not be
furnished, provided that the registrant includes in the prospectus, by means of
a post-effective amendment, financial statements required pursuant to this
paragraph (a)(4) and other information necessary to ensure that all other
information in the prospectus is at least as current as the date of those
financial statements. Not withstanding the foregoing, with respect to
registration statements on Form F-3 (§ 239.33 of this chapter), a
post-effective amendment need not be filed to include financial statements and
information required by Section 10(a)(3) of the Act or § 210.3-19 of
this chapter if such financial statements and information are contained in
periodic reports filed with or furnished to the Commission by the registrant
pursuant to section 13 or section 15(d) of the Securities Exchange Act
of 1934 that are incorporated by reference in the Form F-3.
The
undersigned registrant hereby further undertakes that, for purposes of
determining any liability under the Securities Act of 1933, each filing of the
Registrant’s annual report pursuant to Section 13(a) or Section 15(d)
of the Securities Exchange Act of 1934 (and, where applicable, each filing of an
employee benefit plan’s annual report pursuant to Section 15(d) of the
Securities Exchange Act of 1934) that is incorporated by reference in the
registration statement shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering
thereof.
The
undersigned registrant hereby further undertakes that:
(1) For
purposes of determining any liability under the Securities Act of 1933, the
information omitted from the form of prospectus filed as part of this
registration statement in reliance upon Rule 430A and contained in a form
of prospectus filed by the registrant pursuant to Rule 424(b)(1) or
(4) or 497(h) under the Securities Act shall be deemed to be part of this
registration statement as of the time it was declared effective.
(2) For
the purpose of determining any liability under the Securities Act of 1933, each
post-effective amendment that contains a form of prospectus shall be deemed to
be a new registration statement relating to the securities offered therein, and
the offering of such securities at that time shall be deemed to be the initial
bona fide offering thereof.
II-15
SIGNATURES
<R>
Pursuant
to the requirements of the Securities Act of 1933, the registrant certifies that
it has reasonable grounds to believe that it meets all the requirements for
filing on Form F-1 and has duly caused this registration statement to be
signed on its behalf by the undersigned, thereunto duly authorized, in the city
of Dublin, Ireland, on January 26, 2010.
|
AMARIN
CORPORATION PLC
|
|
By: /s/ John F.
Thero
Name: John
F. Thero
Title: Chief
Financial Officer
|
Pursuant
to the requirements of the Securities Act of 1933, this Registration Statement
has been signed by the following persons in the capacities and on the dates
stated.
/s/ John
F.
Thero
Name: John
F. Thero
Title: Chief
Financial Officer and attorney-in-fact for Dr. Declan Doogan, the Company’s
Interim Chief Executive Officer, for Thomas G. Lynch, Dr. Lars Ekman, Dr. Manus
Rogan, Dr. Joseph Anderson, Dr. James I Healy, Dr. Carl L. Gordon, each a
Director of the Company, and for Donald J. Puglisi, the Company’s Authorized
Representative in the United States
Date: January
26, 2010
</R>
POWER
OF ATTORNEY
KNOW ALL
MEN BY THESE PRESENTS, that each person whose signature appears below
constitutes and appoints Dr. Declan Doogan and John F. Thero, or either of them,
his true and lawful attorneys-in-fact and agents, with full power of
substitution and resubstitution, for him and in his name, place and stead, in
any and all capacities, to sign any and all pre- or post-effective amendments to
this Registration Statement, and to file the same with all exhibits thereto, and
other documents in connection therewith, with the Securities and Exchange
Commission, granting unto said attorneys-in-fact and agents, and each of them,
full power and authority to do and perform each and every act and thing
requisite or necessary to be done in and about the premises, as fully to all
intents and purposes as he might or could do in person, hereby ratifying and
confirming all that said attorneys-in-fact and agents, or any of them, or their
or his substitutes, may lawfully do or cause to be done by virtue
hereof.
<R>
/s/ Joseph
S.
Zakrzewski
Name: Joseph
S. Zakrzewski
Title: Executive
Chairman
Date: January
26, 2010
/s/ Conor
Dalton
Name: Conor
Dalton
Title: Vice
President, Finance and Principal Accounting Officer
Date: January
26, 2010
</R>