As filed
with the Securities and Exchange Commission on June 27, 2008
Registration
No. 333-________
UNITED STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
F-3
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)
|
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:
Geoffrey
E. Liebmann, Esq.
Cahill Gordon & Reindel
LLP
80
Pine Street
New
York, New York 10005
Approximate
date of commencement of proposed sale to the public: from time to time after
the effective date of this Registration Statement.
If only
securities being registered on this form are being offered pursuant to dividend
or interest reinvestment plans, please check the following box. o
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, please 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 registration statement pursuant to General Instruction I.D. or a
post-effective amendment thereto that shall become effective upon filing with
the Commission pursuant to Rule 462(e) under the Securities Act, check the
following box.
If this
form is a post-effective amendment to a registration statement filed pursuant to
General Instruction I.D. filed to register additional securities or additional
classes of securities pursuant to Rule 413(b) under the Securities Act, check
the following box.
|
Title
of each class of
securities
to be registered
|
Amount
to be
registered
|
Proposed
maximum
aggregate
price
per
unit (2)
|
Proposed
maximum
aggregate
offering
price
(2)
|
Amount
of
registration
fee
|
|
Ordinary
shares, par value £0.50 per share (1)
|
13,043,479
shares
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$2.035
|
$26,543,479.76
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$1,043.16
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(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 evidenced by American Depositary Receipts issuable upon
deposit of the ordinary shares.
(2) 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 June 25, 2008.
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.
Subject to Completion dated June 26, 2008.
13,043,479
Ordinary Shares
AMARIN
CORPORATION PLC
From time
to time, the selling shareholders named in this prospectus may offer an
aggregate of 13,043,479 ordinary shares, par value £0.50 per share, each
represented by one American Depositary Share, or ADS, of Amarin Corporation plc.
The selling shareholders are identified in the table commencing on
page 19.
Our ADSs,
evidenced by American Depositary Receipts, are listed on the Nasdaq Capital
Market, the principal trading market for our securities, under the symbol
“AMRN”. On June 25, 2008, the closing sale price for our ADSs, each
representing one ordinary share, on the Nasdaq Capital Market was $2.05 per
ADS.
The ADSs
beneficially owned by the selling shareholders may be offered for sale from time
to time by the selling shareholders directly or in brokerage transactions at
fixed prices, at prevailing market prices, at varying prices determined at the
time of sale or at negotiated prices. 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 1 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
The date
of this prospectus is June ,
2008
TABLE
OF CONTENTS
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Page
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About
This Prospectus
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i
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Risk
Factors
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1
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Cautionary
Note Regarding Forward-Looking Statements
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13
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Incorporation
by Reference
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14
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Where
You Can Find More Information
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15
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Enforceability
of Civil Liabilities
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15
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Use
of Proceeds
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15
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Determination
of Offering Price
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15
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Capitalization
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15
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Price
History
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17
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Selling
Shareholders
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19
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Plan
of Distribution
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21
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Offering
Expenses
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22
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Experts
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22
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Legal
Matters
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22
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Disclosure
of Commission Position on Indemnification for Securities Act
Liabilities
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22
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ABOUT
THIS PROSPECTUS
This
prospectus is part of a registration statement on Form F-3 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 19 may, from time to time, sell the offered
securities described in this prospectus in one or more offerings, up to a total
of 13,043,479 ordinary shares.
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.
-i-
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 develop 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, 2003, 2004 and 2005, we reported
(losses)/profits under U.K. GAAP of approximately $(19.2) million,
$3.2 million and $(20.5) million respectively. For the
fiscal years ended December 31, 2006 and 2007, we reported losses under IFRS of
approximately $26.8 million and $38.2 million respectively. Unless
and until marketing approval is obtained from either the U.S. Food and Drug
Administration, which we refer to as the FDA, or European Medicines Evaluation
Agency, which we refer to as the EMEA, for any of our products, or we are
otherwise able to acquire rights to products that have received regulatory
approval or are at an advanced stage of development and can be readily
commercialized, we may not be able to generate sufficient revenues in future
periods to enable us to attain profitability.
We
acquired Amarin Neuroscience (formerly Laxdale Limited) on October 8, 2004
and Ester Neurosciences Limited on December 5, 2007. We continue to
have limited operations, assets and financial resources. We currently
have no marketable products or other source of revenues other than the Multicell
out-licensing contract described herein. All of our current products
are in the development stage. The development of pharmaceutical
products is a capital intensive business. Therefore, we expect to
incur expenses without corresponding revenues at least until we are able to
obtain regulatory approval and sell our future products in significant
quantities. This may result in net operating losses until we can
generate an acceptable level of revenues, which we may not be able to
attain. Further, even if we do achieve operating revenues, there can
be no assurance that such revenues will be sufficient to fund continuing
operations. Therefore, we cannot predict with certainty whether we
will ever be able to achieve profitability.
In
addition to advancing our existing development pipeline, we may also acquire
rights to additional products. However, we may not be successful in
doing so. We may need to raise additional capital before we can
acquire any products. There is also a risk that any of our
development stage products we may acquire will not be approved by the FDA or
regulatory authorities in other countries on a timely basis or at
all. The inability to obtain such approvals would adversely affect
our ability to generate revenues.
The
likelihood of success of our business plan must be considered in light of the
problems, expenses, difficulties, complications and delays frequently
encountered in connection with developing and expanding early stage businesses
and the regulatory and competitive environment in which we operate.
Our
historical financial results do not form an accurate basis for assessing our
current business.
As a
consequence of divestitures in 2003 and 2004 and our acquisition of Amarin
Neuroscience in October 2004 and Ester Neurosciences Limited in December 2007,
our historical financial results do not form an accurate basis upon which
investors should base an assessment of our business and prospects. We
are now focused on the research, development and commercialization of novel
drugs for the central nervous system and 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,
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 marketing approval in the United States and Europe for any other
product using Amarin Neuroscience intellectual property or for a different
indication of a previously approved product, we must make an aggregate stock or
cash payment (at the sole option of each of the sellers) of GBP£5.0 million
for each of the two potential market approvals (i.e., GBP£10.0 million
maximum). The exchange rate as of May 15, 2008 was approximately
$1.9488 per GBP£.
As
described under the heading “Unaudited Pro Forma Financial Information” in our
report on Form 6-K filed with the SEC on December 5, 2007, if the Monarsen Phase
IIa in Myasthenia Gravis (“MG”) clinical study meets its study objectives, we
are committed to pay $5 million, at Amarin’s option, in equity or cash, to the
former shareholders of Ester Neurosciences Limited. In addition, upon
successful completion of the Monarsen Phase II MG development program with
adequate efficacy and safety data that fully supports the commencement of a
Phase III clinical study in the U.S., we are committed to pay $6 million, at
Amarin’s option, in equity or cash, to the former shareholders of Ester
Neurosciences Limited.
In
December 2007, we issued $2.75 million in aggregate principal amount of
three-year convertible Debentures. The Debenture holders received
five-year warrants to purchase 2.3 million ADSs at an exercise price of
$4.80. If, at any time prior to December 6, 2009, the Company issues
ordinary shares, securities convertible into ADSs or ordinary shares, warrants
to purchase ADSs or ordinary shares or options to purchase any of the
aforementioned warrants at a price that is less than, or converts at a price
that is less than, $3.66 (“Down-round Price”), then the exercise price shall be
adjusted to equal 130% of the Down-round Price. The Debentures were
redeemed and the principal amount repaid in full on May 29, 2008, however,
the warrants issued to the Debenture holders remain outstanding.
Taking
account for the one-for-ten consolidation of our ordinary shares on January 18,
2008, as at May 16, 2008 we had 2,052,473 warrants outstanding with a weighted
average exercise price of $8.70 per share. As at May 16, 2008, we
also had outstanding employee options to purchase 1,475,481 ordinary shares at
an average exercise price of $13.23 per share.
Additionally,
in pursuing our growth strategy we will either need to issue new equity as
consideration for the acquisition of products, or to otherwise raise additional
capital, in which case equity, debt convertible into equity or debt instruments
may be issued. The creation of new shares may lead to dilution of the
value of the shares held by our current shareholder base.
If
we cannot find additional capital resources, we will have difficulty in
operating as a going concern and growing our business.
At
December 31, 2007, we had a cash balance of approximately
$18.3 million. On May 13, 2008, we announced a private placement
of ordinary shares for up to $60.0 million. The first tranche from
new investors of $28.0 million closed on May 16, 2008. The first
tranche from certain ex-directors and significant shareholders of $2.0 million
closed on May 20, 2008. All the investors will have an option to
provide up to an aggregate of $30.0 million in a second tranche upon the
completion or waiver of certain business milestones by the Company, potentially
over the next 12 months. There is no certainty that the investors
will exercise the option to provide the second tranche of this private
placement. Based upon current business activities, we forecast having
sufficient cash to fund operations for at least the next 12 months from
May 16, 2008. We may also require further funds in the future to
implement our long-term growth strategy of acquiring additional development
stage and/or marketable products, recruiting clinical, regulatory and sales and
marketing personnel, and growing our business. Our ability to
execute
-1-
our
business strategy and sustain our infrastructure at our current level will be
impacted by whether or not we have sufficient funds. Depending on
market conditions and our ability to maintain financial stability, we may not
have access to additional funds on reasonable terms or at all. Any
inability to obtain additional funds when needed would have a material adverse
effect on our business and on our ability to operate on an ongoing
basis.
We
may be dependent upon the success of a limited range of products.
On April
24, 2007, we reported top-line results from our two Phase III clinical trials of
AMR101 to treat Huntington’s disease. Study data showed no
statistically significant difference in either study between AMR101 and placebo
with regard to the primary and secondary endpoints at 6-months of
treatment. The adverse clinical trial data on AMR101 for Huntington’s
disease could materially affect our ability to develop the product for
Huntington’s disease and for other therapeutic indications. If
development efforts for our products are not successful for any indications or
if they are not approved by the FDA, or if adequate demand for our products is
not generated, our business will be materially and adversely
affected. Although we intend to bring additional products forward
from our research and development efforts, even if we are successful in doing
so, the range of products we will be able to commercialize may be
limited. This could restrict our ability to respond to adverse
business conditions. If we are not successful in developing any
future product or products, or if there is not adequate demand for any such
products or the market for such product develops less rapidly than we
anticipate, we may not have the ability to shift our resources to the
development of alternative products. As a result, the limited range
of products we intend to develop could constrain our ability to generate
revenues and achieve profitability.
Our
ability to generate revenues depends on obtaining regulatory approvals for our
products.
In order
to successfully commercialize a product, we 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. Additionally,
the terms of any approvals may not have the scope or breadth needed for us to
commercialize products successfully.
We
may not be successful in developing or marketing future products if we cannot
meet extensive regulatory requirements of the FDA and other regulatory agencies
for quality, safety and efficacy.
Our
long-term strategy involves the development of products we may acquire from
third parties. The success of these efforts is dependent in part upon
the ability of the Group, its contractors, and its products to meet and to
continue to meet regulatory requirements in the jurisdictions where we
ultimately intend to sell such products. The development, manufacture
and marketing of pharmaceutical products are subject to extensive regulation by
governmental authorities in the United States, the European Union, Japan and
elsewhere. In the United States, the FDA generally requires
pre-clinical testing and clinical trials of each drug to establish its safety
and efficacy and extensive pharmaceutical development to ensure its quality
before its introduction into the market. Regulatory authorities in
other jurisdictions impose similar requirements. The process of
obtaining regulatory approvals is lengthy and expensive and the issuance of such
approvals is uncertain. The commencement and rate of completion of
clinical trials may be delayed by many factors, including:
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the
inability to manufacture sufficient quantities of qualified materials
under current good manufacturing practices for use in clinical
trials;
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slower
than expected rates of patient
recruitment;
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the
inability to observe patients adequately after
treatment;
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changes
in regulatory requirements for clinical
trials;
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the
lack of effectiveness during clinical
trials;
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unforeseen
safety issues;
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delay,
suspension, or termination of a trial by the institutional review board
responsible for overseeing the study at a particular study
site; and
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government
or regulatory delays or “clinical holds” requiring suspension or
termination of a trial.
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Even if
we obtain positive results from early stage pre-clinical or clinical trials, we
may not achieve the same success in future trials. Clinical trials
that we conduct may not provide sufficient safety and effectiveness data to
obtain the requisite regulatory approvals for product candidates. The
failure of clinical trials to demonstrate safety and effectiveness for our
desired indications could harm the development of that product candidate as well
as other product candidates, and our business and results of operations would
suffer.
Any
approvals that are obtained may be limited in scope, or may be accompanied by
burdensome post-approval study or other requirements. This could
adversely affect our ability to earn revenues from the sale of such
products. Even in circumstances where products are approved by a
regulatory body for sale, the regulatory or legal requirements may change over
time, or new safety or efficacy information may be identified concerning a
product, which may lead to the withdrawal of a product from the
market. Additionally, even after approval, a marketed drug and its
manufacturer are subject to continual review. The discovery of
previously unknown problems with a product or manufacturer may result in
restrictions on 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 NDA or other license is subject to
periodic and other monitoring and reporting obligations enforced by the FDA and
other regulatory bodies, including obligations to monitor and report adverse
events and instances of the failure of a product to meet the specifications in
the approved application. Application holders must also submit
advertising and other promotional material to regulatory authorities and report
on ongoing clinical trials.
Advertising
and promotional materials must comply with FDA rules in addition to other
potentially applicable federal and local laws in the United States and in other
countries. In the United States, the distribution of product samples
to physicians must comply with the requirements of the U.S. Prescription Drug
Marketing Act. Manufacturing facilities remain subject to FDA
inspection and must continue to adhere to the 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 comply with FDA and other requirements, new information regarding the
safety or effectiveness of a product could lead the FDA to modify or withdraw a
product approval. Adverse regulatory action, whether pre or
post-approval, can potentially lead to product liability claims and increase our
product liability exposure. We must also compete against other
products in qualifying for reimbursement under applicable third party payment
and insurance programs.
-3-
Our
future products may not be able to compete effectively against those of our
competitors.
Competition
in the pharmaceutical industry is intense and is expected to
increase. If we are successful in completing the development of any
of our products, we may face competition to the extent that other pharmaceutical
companies are able to develop products for the treatment of similar
indications. Potential competitors in this market may include
companies with greater resources and name recognition than
us. Furthermore, to the extent we are able to acquire or develop
additional marketable products in the future such products will compete with a
variety of other products within the United States or elsewhere, possibly
including established drugs and major brand names. Competitive
factors, including generic competition, could force us to lower prices or could
result in reduced sales. In addition, new products developed by
others could emerge as competitors to our future products. Products
based on new technologies or new drugs could render our products obsolete or
uneconomical.
Our
potential competitors both in the United States and Europe may include large,
well-established pharmaceutical companies, specialty pharmaceutical sales and
marketing companies, and specialized neurology companies. In
addition, we may compete with universities and other institutions involved in
the development of technologies and products that may 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 future products could be dependent upon relationships with
manufacturers and key suppliers.
We have
no in-house manufacturing capacity and, to the extent we are successful in
completing the development of 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 may not be able to enter
into manufacturing arrangements on terms that are favorable to
us. Moreover, if any future manufacturers should cease doing business
with us or experience delays, shortages of supply or excessive demands on their
capacity, we may not be able to obtain adequate quantities of product in a
timely manner, or at all. Manufacturers are required to comply with
current NDA commitments and good manufacturing practices requirements enforced
by the FDA, and similar requirements of other countries. The failure
by a future manufacturer to comply with these requirements could affect its
ability to provide us with product. Any manufacturing problem or the
loss of a contract manufacturer could be disruptive to our operations and result
in lost sales.
Additionally,
we will be reliant on third parties to supply the raw materials needed to
manufacture 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.
We
may not be able to grow our business unless we can acquire and market or
in-license new products.
We are
pursuing a strategy of product acquisitions and in-licensing in order to
supplement our own research and development activity. For example, in
December 2007, we acquired the entire issued share capital of Ester
Neurosciences Limited whose lead product, EN101, is currently in Phase IIa
clinical development to treat myasthenia gravis, a debilitating neuromuscular
disease; in March 2007, we acquired the global rights to a novel, nasal
lorazepam formulation for the out-patient treatment of emergency seizures in
epilepsy patients, specifically status epilepticus and acute repetitive
seizures; and in May 2006, we acquired the global rights to a novel formulation
of apomorphine for the treatment of “off” episodes in patients with advanced
Parkinson’s disease. 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,
-4-
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
inability to acquire additional products or successfully introduce new products
could have a material adverse effect on our business.
In
order to commercialize our future products, we will need to establish a sales
and marketing capability.
At
present, we do not have any sales or marketing capability since all of our
products are currently in the development stage. However, if we are
successful in obtaining regulatory approval for any product for any indication,
we may directly commercialize this product for that indication in the U.S.
market. Similarly, to the extent we execute our long-term strategy of
expanding our portfolio by developing or acquiring additional marketable
products, we intend to directly sell our neurology products in the United
States. In order to market new products, we will need to add
marketing and sales personnel who have expertise in the pharmaceuticals
business. We must also develop the necessary supporting distribution
channels. Although we believe we can build the required
infrastructure, we may not be successful in doing so if we cannot attract
personnel or generate sufficient capital to fund these
efforts. Failure to establish a sales force and distribution network
in the U.S. would have a material adverse effect on our ability to grow our
business.
The
planned expansion of our business may strain our resources.
Our
strategy for growth includes potential acquisitions of new products for
development and the introduction of these products to the
market. Since we currently operate with limited resources, the
addition of such new products could require a significant expansion of our
operations, including the recruitment, hiring and training of additional
personnel, particularly those with a clinical or regulatory
background. Any failure to recruit necessary personnel could have a
material adverse effect on our business. Additionally, the expansion
of our operations and work force could create a strain on our financial and
management resources and it may require us to add management
personnel.
We
may incur potential liabilities relating to discontinued operations or
products.
In
October 2003, we sold Gacell Holdings AB, the Swedish holding company of Amarin
Development AB, which we refer to as ADAB, our Swedish drug development
subsidiary, to Watson Pharmaceuticals, Inc. In February 2004, we sold
our U.S. subsidiary, Amarin Pharmaceuticals Inc., and certain assets, to
Valeant. In connection with these transactions, we provided a number
of representations and warranties to Watson and Valeant regarding the respective
businesses sold to them, and other matters, and we undertook to indemnify Watson
and Valeant under certain circumstances for breaches of such representations and
warranties. We are not aware of any circumstances which could
reasonably be expected to give rise to an indemnification obligation under our
agreements with either Watson or Valeant. However, we cannot predict
whether matters may arise in the future which were not known to us and which,
under the terms of the relevant agreements, could give rise to a claim against
us.
We
will be dependent on patents, proprietary rights and
confidentiality.
Because
of the significant time and expense involved in developing new products and
obtaining regulatory approvals, it is very important to obtain patent and trade
secret protection for new technologies, products and processes. Our
ability to successfully implement our business plan will depend in large part on
our ability to:
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acquire
patented or patentable products and
technologies;
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obtain
and maintain patent protection for our current and acquired
products;
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preserve
any trade secrets relating to our current and future
products; and
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operate
without infringing the proprietary rights of third
parties.
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-5-
Although
we intend to make reasonable efforts to protect our current and future
intellectual property rights and to ensure that any proprietary technology we
acquire does not infringe the rights of other parties, we may not be able to
ascertain the existence of all potentially conflicting
claims. Therefore, there is a risk that third parties may make claims
of infringement against our current or future products or
technologies. In addition, third parties may be able to obtain
patents that prevent the sale of our current or future products or require us to
obtain a license and pay significant fees or royalties in order to continue
selling such products.
We may in
the future discover the existence of products that infringe upon patents that we
own or that have been licensed to us. Although we intend to protect
our trade secrets and proprietary know-how through confidentiality agreements
with our manufacturers, employees and consultants, we may not be able to prevent
our competitors from breaching these agreements or third parties from
independently developing or learning of our trade secrets.
We
anticipate that competitors may from time to time oppose our efforts to obtain
patent protection for new technologies or to submit patented technologies for
regulatory approvals. Competitors may seek to challenge patent
applications or existing patents to delay the approval process, even if the
challenge has little or no merit. Patent challenges are generally
highly technical, time consuming and expensive to pursue. Were we to
be subject to one or more patent challenges, that effort could consume
substantial time and resources, with no assurances of success, even when holding
an issued patent.
The
loss of any key management or qualified personnel could disrupt our
business.
We are
highly dependent upon the efforts of our senior management. The loss
of the services of one or more members of senior management could have a
material adverse effect on us. As a small company with a streamlined
management structure, the departure of any key person could have a significant
impact and would be potentially disruptive to our business until such time as a
suitable replacement is hired. Furthermore, because of the
specialized nature of our business, as our business plan progresses we will be
highly dependent upon our ability to attract and retain qualified scientific,
technical and key management personnel. There is intense competition
for qualified personnel in the areas of our activities. In this
environment, we may not be able to attract and retain the personnel necessary
for the development of our business, particularly if we do not achieve
profitability. The failure to recruit key scientific, technical and
management personnel would be detrimental to our ability to implement our
business plan.
We
are subject to continuing potential product liability.
Although
we disposed of the majority of our former products during 2003 and 2004, we
remain subject to the potential risk of product liability claims relating to the
manufacturing and marketing of our former products during the period prior to
their divestiture. Any person who is injured as a result of using one
of our former products during our period of ownership may have a product
liability claim against us without having to prove that we were at
fault. The potential for liability exists despite the fact that our
former subsidiary, Amarin Pharmaceuticals Inc. conducted all sales and marketing
activities with respect to such products. Although we have not
retained any liabilities of Amarin Pharmaceuticals Inc. in this regard, as the
prior holder of ownership rights to such former products, third parties could
seek to assert potential claims against us. Since we distributed and
sold our products to a wide number of end users, the risk of such claims could
be material.
We do not
at present carry product liability insurance to cover any such
risks. If we were to seek insurance coverage, we may not be able to
maintain product liability coverage on acceptable terms if our claims experience
results in high rates, or if product liability insurance otherwise becomes
costlier or unavailable because of general economic, market or industry
conditions. If we add significant products to our portfolio, we will
require product liability coverage and may not be able to secure such coverage
at reasonable rates or at all.
Product
liability claims could also be brought by persons who took part in clinical
trials involving our current or former development stage products. A
successful claim brought against us could have a material adverse effect on our
business. Amarin does not carry product liability insurance to cover
clinical trials.
-6-
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 U.S. Food and Drug Administration (“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
2007, one lawsuit alleging claims related to cardiac valvulopathy and Permax was
pending in the United States and currently remains pending. Eli
Lilly, Elan, Valeant, Amarin Pharmaceuticals Inc., Athena Neurosciences, Inc.,
and Amarin are named as defendants in this lawsuit, and are defending against
the claims and allegations. The case is currently in
discovery. In addition, a lawsuit alleging claims related to cardiac
valvulopathy and Permax was filed in March 2008 and is currently pending in the
United States. Eli Lilly, Elan, Valeant and Amarin are named as
defendants in this lawsuit. Amarin has not been formally served with
the complaint from this lawsuit.
Two 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.
The Group
has reviewed the position and having taken external legal advice considers the
potential risk of significant liability arising for Amarin from these legal
actions to be remote. No provision is booked in the accounts at
December 31, 2007.
The
price of our ADSs and ordinary shares may be volatile.
The stock
market has from time to time experienced significant price and volume
fluctuations that may be unrelated to the operating performance of particular
companies. In addition, the market prices of the securities of many
pharmaceutical and medical technology companies have been especially volatile in
the past, and this trend is expected to continue in the future. Our
ADSs may also be subject to volatility as a result of their limited trading
market. At December 31, 2007 we had 132,712,369 ADSs representing
ordinary shares outstanding and 6,345,001 ordinary shares outstanding (which are
not held in the form of ADSs). Taking account for the one-for-ten
consolidation of our ordinary shares on January 18, 2008, we currently have
26,194,987 ADSs representing ordinary shares outstanding and 851,729 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, 2007, the average daily trading volume for our ADSs
was 1,161,203 ADSs.
If our
public float and the level of trading remain at limited levels over the long
term, this could result in volatility and increase the risk that the market
price of our ADSs and ordinary shares may be affected by factors such
as:
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the
announcement of new products or
technologies;
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-7-
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innovation
by us or our competitors;
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developments
or disputes concerning any future patent or proprietary
rights;
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actual
or potential medical results relating to our products or our competitors’
products;
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interim
failures or setbacks in product
development;
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regulatory
developments in the United States, the European Union or other
countries;
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currency
exchange rate
fluctuations; and
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period-to-period
variations in our results of
operations.
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The
issuances of ADSs and ordinary shares upon the 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.
U.S.
holders of our ordinary shares or ADSs could be subject to material adverse tax
consequences if we are considered a PFIC for U.S. federal income tax
purposes.
There is
a risk that we will be classified as a passive foreign investment company, or
“PFIC”, for U.S. federal income tax purposes. Our status as a PFIC
could result in a reduction in the after-tax return to U.S. Holders of our
ordinary shares or ADSs and may cause a reduction in the value of such
shares. We will be classified as a PFIC for any taxable year in which
(i) 75% or more of our gross income is passive income or (ii) at least
50% of the average value of all our assets produce or are held for the
production of passive income. For this purpose, passive income
includes interest, gains from the sale of stock, and royalties that are not
derived in the active conduct of a trade or business. Because we
receive interest and may 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.
-8-
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 will be 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
ADSs 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 and our ordinary shares were admitted to trading
on the AIM market of the London Stock Exchange and the IEX market of the Irish
Stock Exchange on July 17, 2006. 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 1985 (as
amended) that remain in force and the Companies Act 2006 (together the
“Companies Acts”), and by our memorandum and articles of association and the
Group is subject to the rules of AIM and IEX. These rights differ in
certain respects from the rights of shareholders in typical U.S.
corporations. The principal differences include the
following:
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Under
English law, each shareholder present at a meeting has only one vote
unless a valid demand is made for a vote on a poll, in which each holder
gets one vote per share owned. Under U.S. law, each shareholder
typically is entitled to one vote per share at all
meetings. Under English law, it is only on a poll that the
number of shares determines the number of votes a holder may
cast. You should be aware, however, that the voting rights of
ADSs are also governed by the provisions of a deposit agreement with our
depositary bank.
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Under
English law, each shareholder generally has pre-emptive rights to
subscribe on a proportionate basis to any issuance of
shares. Under U.S. law, shareholders generally do not have
pre-emptive rights unless specifically granted in the certificate of
incorporation or otherwise.
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Under
English law, certain matters require the approval of 75% of the
shareholders, including amendments to the memorandum and articles of
association. This may make it more difficult for us to complete
corporate transactions deemed advisable by our board of
directors. Under U.S. law, generally only majority shareholder
approval is required to amend the certificate of incorporation or to
approve other significant transactions. Under the rules of AIM
and IEX, certain transactions require the approval of 50% of the
shareholders, including disposals resulting in a fundamental change of
business and reverse takeovers. In addition, certain
transactions with a party related to the Group for the purposes of the AIM
rules requires that the Group consult with its nominated adviser as to
whether the transaction is fair and reasonable as far as shareholders are
concerned.
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Under
English law, shareholders may be required to disclose information
regarding their equity interests upon our request, and the failure to
provide the required information could result in the loss or restriction
of rights attaching to the shares, including prohibitions on the transfer
of the shares, as well as restrictions on dividends and other
payments. Comparable provisions generally do not exist under
U.S. law.
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The
quorum requirements for a shareholders’ meeting is a minimum of two
persons present in person or by proxy. Under U.S. law, a
majority of the shares eligible to vote must generally be present (in
person or by proxy) at a shareholders’ meeting in order to constitute a
quorum. The minimum number of shares required for a quorum can
be reduced pursuant to a provision in a company’s
certificate
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-9-
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,
including Amarin Finance Limited, are non-residents of the United States, and
all or a substantial portion of the assets of such persons are located outside
the United States. As a result, it may not be possible for investors
to affect service of process within the United States upon such persons or to
enforce against them judgments obtained in U.S. courts predicated upon the civil
liability provisions of the federal securities laws of the United
States. We have been advised by our English solicitors that there is
doubt as to the enforceability in England in original actions, or in actions for
enforcement of judgments of U.S. courts, of civil liabilities to the extent
predicated upon the federal securities laws of the United
States. Amarin Finance Limited is an exempted company limited by
shares organized under the laws of Bermuda. We have been advised by
our Bermuda attorneys that uncertainty exists as to whether courts in Bermuda
will enforce judgments obtained in other jurisdictions (including the United
States) against us or our directors or officers under the securities laws of
those jurisdictions or entertain actions in Bermuda against us or our directors
or officers under the securities laws of other jurisdictions.
Foreign
currency fluctuations may affect our future financial results or cause us to
incur losses.
We
prepare our financial statements in U.S. Dollars. Since our strategy
involves the development of products for the U.S. market, a significant part of
our clinical trial expenditures are denominated in U.S. Dollars and we
anticipate that the majority of our future revenues will be denominated in U.S.
Dollars. However, a significant portion of our costs are denominated
in pounds sterling, euro and shekel as a result of our being engaged in
activities in the United Kingdom, the European Union and Israel. 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, euro or shekel on the other hand. We
are focused on development activities and do not anticipate generating ongoing
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, euro and/or the shekel may affect our revenues and operating
margins. In general, we could incur losses if the U.S. Dollar should
become devalued relative to pounds sterling, euro and/or the
shekel.
We
do not currently have the capability to undertake manufacturing of any potential
products.
We have
not invested in manufacturing and have no manufacturing
experience. We cannot assure you that we will successfully
manufacture any product we may develop, either independently or under
manufacturing arrangements, if any, with third party
manufacturers. To the extent that we enter into contractual
relationships with other companies to manufacture our products, if any, the
success of those products may depend on the success of securing and maintaining
contractual relationships with third party manufacturers (and any
sub-contractors they engage).
We
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 sub-contractors
they engage).
We
have limited personnel to oversee outsourced clinical testing and the regulatory
approval process.
It is
likely that we will also need to hire additional personnel skilled in the
clinical testing and regulatory compliance process if we develop additional
product candidates with commercial potential. We do not
currently
-10-
have the
capability to conduct clinical testing in-house and do not currently have plans
to develop such a capability. We outsource 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 unproven technologies to the
development of biopharmaceutical products for the treatment of neurological
disorders. We cannot assure you that unforeseen problems will not
develop with these technologies or applications or that commercially feasible
products will ultimately be developed by us.
Third-party
reimbursement and health care cost containment initiatives and treatment
guidelines may constrain our future revenues.
Our
ability to market successfully our existing and future new products will depend
in part on the level of reimbursement that government health administration
authorities, private health coverage insurers and other organizations provide
for the cost of our products and related treatments. Countries in
which our products are sold through reimbursement schemes under national health
insurance programs frequently require that manufacturers and sellers of
pharmaceutical products obtain governmental approval of initial prices and any
subsequent price increases. In certain countries, including the
United States, government-funded and private medical care plans can exert
significant indirect pressure on prices. We may not be able to sell
our products profitably if adequate prices are not approved or reimbursement is
unavailable or limited in scope. Increasingly, third-party payers
attempt to contain health care costs in ways that are likely to impact our
development of products including:
-11-
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failing
to approve or challenging the prices charged for health care
products;
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introducing
reimportation schemes from lower priced
jurisdictions;
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limiting
both coverage and the amount of reimbursement for new therapeutic
products;
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denying
or limiting coverage for products that are approved by the regulatory
agencies but are considered to be experimental or investigational by
third-party payers;
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refusing
to provide coverage when an approved product is used in a way that has not
received regulatory marketing
approval; and
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refusing
to provide coverage when an approved product is not appraised favorably by
the National Institute for Clinical Excellence in the U.K., or similar
agencies in other countries.
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We
are undergoing significant organizational change. Failure to manage
disruption to the business or the loss of key personnel could have an adverse
effect on our business.
We are
making significant changes to both our management structure and the locations
from which we operate. As a result of this, in the short term, morale
may be lowered and key employees may decide to leave, or may be distracted from
their usual role. This could result in delays in development
projects, failure to achieve managerial targets or other disruption to the
business which could have material adverse affects on our business and results
of operations.
-12-
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 1. Some, but not all, of these factors are the timing of
our future capital needs and our ability to raise additional capital when
needed, our ability to obtain regulatory approval for our products, uncertainty
of market acceptance of our products, our ability to compete with other
pharmaceutical companies, our ability to develop or acquire new products,
problems with important third-party manufacturers on whom we rely, our ability
to attract and retain key personnel, and implementation and enforcement of
government regulations. 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.
-13-
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 certain later information that we file with the SEC will automatically update and
supersede this information. We incorporate by reference the following
documents:
|
|
(i)
|
our
annual report on Form 20-F for the fiscal year ended
December 31, 2007 filed on May 19, 2008;
and
|
|
|
(ii)
|
our
reports on Form 6-K dated January 8, 2008, January 9, 2008,
January 10, 2008, January 17, 2008, January 18, 2008,
January 28, 2008, February 1, 2008, February 4, 2008,
February 11, 2008, March 3, 2008, May 14, 2008,
May 19, 2008, May 22, 2008 and June 19,
2008.
|
All
annual reports we file with the SEC pursuant to the Securities Exchange Act of
1934 on Form 20-F after the date of this prospectus and prior to the
termination of the offering shall be deemed to be incorporated by reference into
this prospectus and to be part hereof from the date of filing of such
documents. We may incorporate by reference any report on
Form 6-K subsequently submitted to the SEC by identifying in such Form that
it is being incorporated by reference into this prospectus.
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, unless such exhibits are specifically incorporated by reference 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.
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.
-14-
We file
reports, including annual reports on Form 20-F, and other information with
the SEC pursuant to the rules and regulations of the SEC that apply to foreign
private issuers. 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.
We
provide Citibank N.A., as depositary under the deposit agreement between us, the
depositary and registered holders of the American Depositary Receipts evidencing
ADSs, with annual reports, including a review of operations, and annual audited
consolidated financial statements prepared in conformity with 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.
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 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.
All of the
ordinary shares offered by this prospectus are being offered by the selling
shareholders listed in the table commencing on page 19. We will not receive
any proceeds from sales of ordinary shares by the selling
shareholders.
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”.
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 offer
and sell ADSs on the Nasdaq Capital Market at prevailing market prices. The
selling shareholders may also offer and sell the ordinary shares in privately
negotiated transactions at prices other than the then prevailing market
price.
CAPITALIZATION
AND INDEBTEDNESS
The
following table sets forth, on an IFRS basis, our capitalization as of
March 31, 2008 on an actual basis and as adjusted to give effect to the
Private Placement (as defined below) as if the Private Placement occurred on
or
-15-
before
March 31, 2008. This table should be read in conjunction with
our consolidated financial statements as of and for the two years ended
December 31, 2007 set forth in our annual report on Form 20-F
(incorporated by reference herein), together with our quarterly earning release
and interim financial information furnished under Form 6-K on May 19,
2008.
As at
March 31, 2008, Amarin Corporation plc held approximately $8.8 million
of cash balances.
|
Actual
$’000
|
Pro
forma
$’000
|
|||||||
|
Long Term Debt1
|
2,694 | - | ||||||
|
Shareholders’
equity:
|
||||||||
|
Ordinary
share capital
|
13,040 | 25,906 | ||||||
|
Treasury
shares
|
(217 | ) | (217 | ) | ||||
|
Capital
redemption reserve
|
27,633 | 27,633 | ||||||
|
Other
reserves (share based payments, warrants, etc.)
|
21,925 | 13,650 | ||||||
|
Share
premium account
|
147,918 | 161,666 | ||||||
|
Profit
and loss account — (deficit)
|
(192,784 | ) | (192,784 | ) | ||||
|
Total
shareholders’ equity
|
17,515 | 35,854 | ||||||
|
Total
capitalization
|
20,209 | 35,854 | ||||||
In May
2008, the Company issued 13,043,479 ordinary shares to the selling shareholders
identified herein and eight Series A preference shares to certain of such
selling shareholders for an aggregate consideration of $30 million in a private
placement (the “Private Placement”). For more information on the
Private Placement, see “Selling Shareholders”. The pro forma
information above shows the estimated impact of the Private Placement on the
balances as at March 31, 2008 (including the repayment of all of the
outstanding principal amount of the Debentures). Expenses associated
with the Private Placement and 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 “Offering Expenses” on page 22.
|
1
|
Represents
the accounting fair value, at March 31, 2008, of $2.75 million in
aggregate principal amount of three-year convertible Debentures issued in
December 2007. The Debentures were redeemed and the principal
amount repaid in full on May 29, 2008 with a portion of the proceeds
of the Private Placement.
|
-16-
The
following table sets forth the range of high and low closing sale prices for our
ADSs for the periods indicated, as reported by the Nasdaq Capital
Market. These prices do not include retail mark-ups, markdowns, or
commissions. The share price information reflects historical prices
and the information relating to periods prior to January 18, 2008 have not
been adjusted to give effect to the one-for-ten stock consolidation which became
effective on January 18, 2008.
|
US$
High
|
US$
Low
|
|||||||
|
Fiscal
Year Ended
|
||||||||
|
December 31,
2003
|
4.81
|
1.39
|
||||||
|
December 31,
2004
|
3.99
|
0.53
|
||||||
|
December 31,
2005
|
3.40
|
1.06
|
||||||
|
December 31,
2006
|
3.74
|
1.27
|
||||||
|
December 31,
2007
|
3.78
|
0.23
|
||||||
|
Fiscal
Year Ended December 31, 2006
|
||||||||
|
First
Quarter
|
3.74
|
1.27
|
||||||
|
Second
Quarter
|
3.10
|
1.93
|
||||||
|
Third
Quarter
|
2.96
|
2.23
|
||||||
|
Fourth
Quarter
|
2.67
|
1.96
|
||||||
|
Fiscal
Year Ended December 31, 2007
|
||||||||
|
First
Quarter
|
2.62
|
1.74
|
||||||
|
Second
Quarter
|
3.78
|
0.52
|
||||||
|
Third
Quarter
|
0.58
|
0.36
|
||||||
|
Fourth
Quarter
|
0.45
|
0.23
|
||||||
|
Fiscal
Year Ended December 31, 2008
|
||||||||
|
First
Quarter
|
3.59
|
1.81
|
||||||
|
Month
Ended
|
||||||||
|
December 2007
|
0.40
|
0.23
|
||||||
|
January 2008
|
2.90
|
1.81
|
||||||
|
February 2008
|
3.59
|
2.83
|
||||||
|
March 2008
|
2.95
|
2.59
|
||||||
|
April 2008
|
3.07
|
2.60
|
||||||
|
May 2008
|
2.74
|
2.41
|
||||||
On
June 25, 2008, the closing price of our ADSs as reported on the Nasdaq
Capital Market was $2.05 per ADS.
-17-
In May
2008, the Company issued 13,043,479 ordinary shares to the selling shareholders
listed below and eight Series A preference shares to certain of such selling
shareholders for an aggregate consideration of $30 million in the Private
Placement.
The
selling shareholders are offering up to 13,043,479 ordinary shares, each
represented by one ADS, in connection with this offering.
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 June 25, 2008, 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(1)
|
Percentage
of Ordinary Shares Owned Prior to Offering(1)(2)
|
Ordinary
Shares to be Offered
|
Ordinary
Shares to be Owned Upon Completion of the
Offering(1)
|
Percentage
of Ordinary Shares to be Owned Upon Completion of the
Offering(1)(2)
|
|||||||||||||||
|
Sofinnova
Venture Partners VII, L.P.(3)
c/o
Sofinnova Ventures, Inc.
140
Geary St., 10th Fl.
San
Francisco, CA 94108
|
3,586,957 | 12.06 | % | 3,586,957 | 0 | 0 | % | |||||||||||||
|
Caduceus
Private Investments III, LP(4)
c/o
OrbiMed Advisors, LLC
767
Third Ave., 30th Fl.
New
York, NY 10017
|
3,230,107 | 10.86 | % | 3,230,107 | 0 | 0 | % | |||||||||||||
|
OrbiMed
Associates III, LP(5)
c/o
OrbiMed Advisors, LLC
767
Third Ave., 30th Fl.
New
York, NY 10017
|
30,763 | 0.10 | % | 30,763 | 0 | 0 | % | |||||||||||||
|
Panorama
Capital, L.P.(6)
c/o
Panorama Capital Management, LLC
2440
Sand Hill Rd., Suite 302
Menlo
Park, CA 94025
|
1,847,826 | 6.21 | % | 1,847,826 | 0 | 0 | % | |||||||||||||
|
Thomas,
McNerney & Partners II, L.P.(7)
c/o
Thomas, McNerney & Partners II, LLC
60
S. 6th St., Suite 3620
Minneapolis,
MN 55402
|
2,143,913 | 7.21 | % | 2,143,913 | 0 | 0 | % | |||||||||||||
-18-
|
TMP
Nominee II, LLC(8)
c/o
Thomas, McNerney & Partners II, LLC
60
S. 6th St., Suite 3620
Minneapolis,
MN 55402
|
22,391 | 0.08 | % | 22,391 | 0 | 0 | % | |||||||||||||
|
TMP
Associates II, L.P. (9)
c/o
Thomas, McNerney & Partners II, LLC
60
S. 6th St., Suite 3620
Minneapolis,
MN 55402
|
7,609 | 0.03 | % | 7,609 | 0 | 0 | % | |||||||||||||
|
Longitude
Venture Partners, L.P.(10)
c/o
Longitude Capital Partners, LLC
3000
Sand Hill Rd.
Bldg.
1, Suite 230
Menlo
Park, CA 94025
|
1,086,957 | 3.65 | % | 1,086,957 | 0 | 0 | % | |||||||||||||
|
Fountain
Healthcare Partners Fund 1, L.P.
c/o
Fountain Healthcare Partners Ltd.
Adelaide
Chambers
Peter
St.
Dublin
2, Ireland
|
217,391 | 0.73 | % | 217,391 | 0 | 0 | % | |||||||||||||
|
Sunninghill
Limited(11)
P.O.
Box 76
Kleinwort
Benson House
Wests
Centre, St. Helier
Jersey JE4
8PQ
|
1,469,090 | 4.94 | % | 521,739 | 947,351 | 3.18 | % | |||||||||||||
|
Simon
Kukes(12)
Samara
Nafta
Smolensky
Blvd.
4
Moscow 119034
Russia
|
1,279,696 | 4.30 | % | 326,087 | 953,609 | 3.21 | % | |||||||||||||
|
Michael
Walsh(13)
45
Wellington Road
Ballsbridge
Dublin
4, Ireland
|
76,829 | 0.26 | % | 21,739 | 55,090 | 0.19 | % | |||||||||||||
|
Total
|
14,999,529 | 50.42 | % | 13,043,479 | 1,956,050 | 6.57 | % |
(1) Does
not include ordinary shares which the selling shareholders have the option to
purchase, exercisable at any time through completion or waiver of agreed
milestones, in an amount up to approximately $30 million in a second tranche of
the Private Placement. If this second tranche occurs, the per share
purchase price for each ordinary share purchased in the second tranche will
equal the lesser of (a) $2.60 and (b) the product of (i) the average
of
-19-
the
volume weighted average prices as published on the HP screen on Bloomberg of the
ADSs as reported on Nasdaq for each of the 30 trading days immediately prior to
the closing date of the second tranche and (ii) 1.13.
(2) Shares
outstanding used in this computation include 27,046,716 ordinary shares
outstanding as of June 25, 2008 and 2,704,643 ordinary shares issuable upon
exercise of warrants, options or other rights currently outstanding that are
currently exercisable or exercisable within the next 60 days.
(3) Sofinnova
Management VII, L.L.C., the general partner of Sofinnova Venture Partners VII,
L.P., may be deemed to have shared voting power and shared dispositive power,
and Michael F. Powell, PhD., James I Healy, MD, PhD, and Eric P. Buatois, the
managing members of Sofinnova Management VII, L.L.C., may be deemed to have
shared power to vote and shared power to dispose of these shares. Dr.
Healy is a non-executive director of the Company.
(4) OrbiMed
Capital GP III LLC, the general partner of Caduceus Private Investments III, LP,
may be deemed to have shared voting power and shared dispositive power, and
Samuel D. Isaly, the managing partner of OrbiMed Capital GP III LLC, may be
deemed to have shared power to vote and shared power to dispose of theses
shares. Carl L. Gordon, a partner in OrbiMed Capital GP III LLC, is a
non-executive director of the Company.
(5) OrbiMed
Advisors LLC, the general partner of OrbiMed Associates III, LP, may be deemed
to have shared voting power and shared dispositive power, and Samuel D. Isaly,
the managing partner of OrbiMed Advisors LLC, may be deemed to have shared power
to vote and shared power to dispose of theses shares. Carl L. Gordon,
a partner in OrbiMed Advisors LLC, is a non-executive director of the
Company.
(6) Panorama
Capital Management, LLC, the general partner of Panorama Capital, L.P., may be
deemed to have shared voting power and shared dispositive power, and Srinivas
Akkaraju, MD, PhD, Christopher J. Albinson, Rodney A. Ferguson, Shahan D.
Soghikian and Damion Wicker, the managing members of Panorama Capital
Management, LLC, may be deemed to have shared power to vote and shared power to
dispose of these shares. Dr. Akkaraju is a non-executive director of
the Company.
(7) Thomas,
McNerney & Partners II, LLC, the general partner of Thomas McNerney &
Partners II, L.P., may be deemed to have shared voting power and shared
dispositive power, and James Thomas, Pete McNerney, Alex Zisson, Pratik Shah and
Eric Aguiar, MD, the managing members of Thomas, McNerney & Partners II,
LLC, may be deemed to have shared power to vote and shared power to dispose of
these shares. Dr. Aguiar is a non-executive director of the
Company.
(8) James
Thomas and Pete McNerney, the managing members of TMP Nominee II, LLC, may be
deemed to have shared power to vote and shared power to dispose of these
shares.
(9) Thomas,
McNerney & Partners II, LLC, the general partner of TMP Associates II, L.P.,
may be deemed to have shared voting power and shared dispositive power, and
James Thomas, Pete McNerney, Alex Zisson, Pratik Shah and Eric Aguiar, MD, the
managing members of Thomas, McNerney & Partners II, LLC, may be deemed to
have shared power to vote and shared power to dispose of these
shares. Dr. Aguiar is a non-executive director of the
Company.
(10) Longitude
Capital Associates, L.P., an affiliate of Longitude Venture Partners, L.P., and
Longitude Capital Partners, LLC, the general partner of Longitude Venture
Partners, L.P. and Longitude Capital Associates, L.P., may be deemed to have
shared voting power and shared dispositive power, and Patrick Enright and Juliet
Tammenoms Bakker, the managing members of Longitude Capital Partners, LLC, may
be deemed to have shared power to vote and shared power to dispose of these
shares.
(11) Sunninghill
Limited is an entity controlled by Dr. John Climax, one of our non-executive
directors.
(12) Simon
Kukes served as a non-executive director of the Company until May 16,
2008.
(13) Michael
Walsh served as a non-executive director of the Company until May 16,
2008.
-20-
We are registering the ordinary shares on
behalf of the selling shareholders. As used in this prospectus,
selling shareholders includes donees and pledgees selling ordinary shares or
ADSs received from a selling shareholder after the date of 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 private transactions at negotiated
prices or such other 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, in negotiated transactions, 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 of 1933, 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 are ADSs by the selling shareholders.
The
selling shareholders may effect such 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.
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. The selling
shareholders may agree to indemnify any agent, dealer or broker-dealer that
participates in transactions involving sales 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.
-21-
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 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.
|
Securities
and Exchange Commission Registration Fee
|
$1,043
|
|||
|
Placement
Fees and Expenses related to the Private Placement
|
1,880,950 | |||
|
Legal
Fees and Expenses
|
1,045,000 | |||
|
Initial
Stamp Duty*
|
450,000 | |||
|
Miscellaneous
|
10,000 | |||
|
Total
|
$3,386,993
|
|||
*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% of the market
value of the ordinary shares on the date of conversion which occurred in May
2008. 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 the
Private Placement. For the purpose of this calculation we have used
the closing price on the Nasdaq Capital Market on June 25, 2008 of $2.05
based on the initial conversion of 13,043,479 ordinary shares into ADSs.
The financial
statements incorporated in this registration statement by reference to our
annual report on Form 20-F for the year ended December 31, 2007 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.
LEGAL
MATTERS
The
validity of the ordinary shares offered hereby has been passed upon by
Kirkpatrick & Lockhart Preston Gates Ellis LLP (registered in
England).
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.
-22-
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item
8. 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:
Subject
to and so far as may be permitted by the Acts, every director or other officer
and the Auditors of the Company shall be indemnified out of the assets of the
Company against all costs, charges, expenses, losses and liabilities which he
may sustain or incur in or about the execution of his office or otherwise in
relation thereto in respect of any liability incurred by him in defending any
proceedings, civil or criminal, which relate to anything done or omitted or
alleged to have been done or omitted by him as an officer or employee of the
Company and in which judgment is given in his favour, or the proceedings
otherwise disposed of without any finding or admission of any material breach of
duty on his part, or in which he is acquitted or in connection with any
application under any statute for relief from liability in respect of any such
act or omission in which relief is granted by the Court. Such other indemnities
shall be provided to every Director or other officer as are appropriate and in
accordance with the law.
Traditionally,
companies cannot exempt directors and auditors from, or indemnify them against,
liability where they are negligent, in default, or in breach of duty or trust.
The reason for this is that directors owe duties to their company and Parliament
has considered in the past that, in the interests of shareholders, directors
should have to face the consequences of their derelictions of duty.
This
basic prohibition still stands but pursuant to the UK Companies (Audit,
Investigations and Community Enterprise) Act 2004 and as re-enacted and amended
by the 2006 Act, companies can take advantage of a specific exemption to
indemnify directors against liabilities to third parties, and can pay directors'
costs of defense proceedings as they are incurred (subject to an obligation to
repay if the defense is not successful). This was to address concerns that
directors of companies with a US listing may face class actions in the US and to
help alleviate (at least in the short term) the cost to directors of lengthy
court proceedings. The key points of the 2006 Act are:
|
·
|
Companies
may indemnify directors against the legal and financial costs of
proceedings brought by third parties. This does not extend to the legal
costs of unsuccessful defence of criminal proceedings, fines imposed by
criminal proceedings and fines imposed by regulatory
bodies;
|
|
·
|
Companies
may pay directors' defence costs as they are incurred in civil or criminal
cases, even if the action is brought by the company itself. However, a
director in this situation will be required to pay any damages awarded to
the company and to reimburse the company if he fails in his defence
(unless the company has indemnified him in respect of his legal costs
incurred in civil third party
proceedings);
|
|
·
|
Pension
trustee companies (and their associated companies) may indemnify a
director of a qualifying pension scheme against liability incurred in
connection with the company's activities as trustee of that
scheme;
|
|
·
|
Companies
may not provide indemnities to directors of UK-incorporated associated
companies where it would be unlawful for that indemnity to be provided by
the associated company;
|
|
·
|
Companies
may indemnify officers other than
directors;
|
|
·
|
Funds
provided by the company to a director for these purposes are permitted
under section 330 of the Companies Act
1985;
|
|
·
|
Any
indemnities provided by a company will need to be disclosed in the
directors' report and shareholders will be able to inspect any
indemnification agreement;
|
-1-
|
·
|
A
decision to indemnify directors under the new rules can be taken by a
Company's board and no shareholder vote is required by the legislation;
and
|
|
·
|
Shareholders
may by ordinary resolution ratify an act of a director, although the votes
of the relevant director or any person connected with him will not be
counted.
|
In
addition, 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 the following directors:
Thomas G. Lynch, Dr. William Mason, Dr. John Climax and Anthony
Russell-Roberts.
Insofar
as indemnification for liabilities arising under the Securities Act of 1933 may
be permitted to directors, officers and controlling persons of the Company
pursuant to the charter provision, by-law, contract, arrangements, statute or
otherwise, the Company acknowledges that in the opinion of the Securities and
Exchange Commission such indemnification is against public policy as expressed
in the Act and is, therefore, unenforceable.
Item
9. Exhibits
|
Form
of 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)
|
|
|
4.2
|
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)
|
|
4.3
|
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)
|
|
4.4
|
Form
of Ordinary Share certificate(4)
|
|
4.5
|
Form
of American Depositary Receipt evidencing ADSs (included in
Exhibit 2.3)(3)
|
|
4.6
|
Form
of Equity Securities Purchase Agreement dated May 13, 2008 between
Amarin Corporation plc and the Purchasers named
therein(5)
|
|
5.1
|
Opinion
of Kirkpatrick &Lockhart Preston Gates Ellis LLP as to the validity of
the ordinary shares in May 2008*
|
|
23.1
|
Consent
of PricewaterhouseCoopers *
|
|
23.2
|
Consent
of Kirkpatrick &Lockhart Preston Gates Ellis LLP*
|
|
24.1
|
Power
of Attorney (included as part of the signature pages
hereof)
|
|
*
|
Filed
herewith
|
|
(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.
|
|
(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 Post-Effective Amendment No. 2 to Form F-6, File No.
333-5946, filed with the Securities and Exchange Commission on
September 26, 2002.
|
|
(4)
|
Incorporated
herein by reference to certain exhibits to the Group’s Annual Report on
Form 20-F for the year ended December 31, 2002, filed with the
Securities and Exchange Commission on April 24,
2003.
|
-2-
|
(5)
|
Incorporated
herein by reference to certain exhibits to the Group’s Annual Report on
Form 20-F for the year ended December 31, 2007, filed with the
Securities and Exchange Commission on May 19,
2008.
|
Item
10. 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.
(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.
-3-
(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.
-4-
SIGNATURES
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-3 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 June 27, 2008.
|
AMARIN
CORPORATION PLC
|
|
By: /s/ Thomas G.
Lynch
|
|
Name: Thomas
G. Lynch
|
|
Title: Chief Executive
Officer
|
POWER OF ATTORNEY
KNOW ALL
MEN BY THESE PRESENTS, that each person whose signature appears below
constitutes and appoints Thomas G. Lynch and Alan Cooke, 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.
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/ Thomas G.
Lynch
Name:
Thomas G. Lynch
Title:
Chief Executive Officer, Chairman and Director
Date:
June 27, 2008
|
|
/s/ Alan
Cooke
Name:
Alan Cooke
Title:
President, Chief Operating Officer and Chief Financial Officer (principal
financial officer)
Date:
June 27, 2008
|
|
/s/ Conor
Dalton
Name:
Conor Dalton
Title:
Vice President Finance (principal accounting officer)
Date:
June 27, 2008
|
|
/s/ Dr. William
Mason
Name:
Dr. William Mason
Title:
Director (Lead Independent Director)
Date:
June 27, 2008
|
II-1
|
/s/ Eric
Aguiar
Name:
Eric Aguiar, MD
Title:
Director
Date:
June 27, 2008
|
||
|
/s/ Srinivas
Akkaraju
Name:
Srinivas Akkaraju, MD, PhD
Title:
Director
Date:
June 27, 2008
|
||
|
/s/ James I.
Healy
Name:
James I. Healy, MD, PhD
Title:
Director
Date:
June 27, 2008
|
||
|
/s/ Carl L.
Gordon
Name:
Carl L. Gordon
Title:
Director
Date:
June 27, 2008
|
||
|
/s/ Donald J.
Puglisi
Name:
Donald J. Puglisi
Title:
Authorized Representative in the United States
Date:
June 27, 2008
|
||
II-2
|
4.1
|
Form
of 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)
|
|
4.2
|
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)
|
|
4.3
|
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)
|
|
4.4
|
Form
of Ordinary Share certificate (4)
|
|
4.5
|
Form
of American Depositary Receipt evidencing ADSs (included in
Exhibit 2.3) (3)
|
|
4.6
|
Form
of Equity Securities Purchase Agreement dated May 13, 2008 between
Amarin Corporation plc and the Purchasers named
therein (5)
|
|
5.1
|
Opinion
of Kirkpatrick &Lockhart Preston Gates Ellis LLP as to the validity of
the ordinary shares in May 2008 *
|
|
23.1
|
Consent
of PricewaterhouseCoopers *
|
|
23.2
|
Consent
of Kirkpatrick &Lockhart Preston Gates Ellis
LLP *
|
|
24.1
|
Power
of Attorney (included as part of the signature pages
hereof)
|
|
*
|
Filed
herewith
|
|
(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.
|
|
(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 Post-Effective Amendment No. 2 to Form F-6, File No.
333-5946, filed with the Securities and Exchange Commission on
September 26, 2002.
|
|
(4)
|
Incorporated
herein by reference to certain exhibits to the Group’s Annual Report on
Form 20-F for the year ended December 31, 2002, filed with the
Securities and Exchange Commission on April 24,
2003.
|
|
(5)
|
Incorporated
herein by reference to certain exhibits to the Group’s Annual Report on
Form 20-F for the year ended December 31, 2007, filed with the
Securities and Exchange Commission on May 19,
2008.
|
II-3