RNS Number:9394Q
Amarin Corporation Plc
08 February 2007
AMARIN REPORTS FOURTH QUARTER AND FULL YEAR 2006 RESULTS
Conference Call at 8.30 a.m. Eastern Standard Time on February 8, 2007
LONDON, United Kingdom, February 8, 2007 - Amarin Corporation plc (NASDAQ: AMRN)
("Amarin" or "Company") today reported financial results for the fourth quarter
and full year ended December 31, 2006.
For the fourth quarter of 2006, Amarin reported a net loss of $6.5 million, or
$0.07 per share, compared with an adjusted net loss of $5.8 million, or $0.11
per share, in the fourth quarter of 2005. For the year ended December 31, 2006,
Amarin reported a net loss of $26.9 million or $0.33 per share, compared with an
adjusted net loss of $20.5 million, or $0.44 per share for the year ended
December 31, 2005. The increase in net loss for the quarter and for 2006 was
primarily due to Amarin's investment in the two Phase III trials with Miraxion
in Huntington's disease and also the development costs associated with its novel
oral formulation of apomorphine for advanced Parkinson's disease. The net loss
for the comparative period ending December 31, 2005 has been adjusted to reflect
the adoption of Financial Reporting Standard 20 ("FRS 20") which became
effective on January 1, 2006, as further explained below.
Rick Stewart, Chief Executive Officer of Amarin, commented, "2006 was a year of
considerable achievement for Amarin. The on-time recruitment of the Huntington's
disease trials with over 600 patients and its recently announced completion are
major milestones for the Company. This could not have been achieved without the
dedication of the Huntington Study Group, the European HD Network, the patients
involved in the trial, their care-givers and families. We look forward to
releasing the top line results in mid second quarter."
Mr Stewart continued, "Additionally, we made good progress with Miraxion in
other indications such as Parkinson's disease and melancholic depression. We
also expanded Amarin's development pipeline with the acquisition of global
rights to a novel oral formulation of apomorphine and made significant progress
on its development during the year."
Key recent and 2006 highlights include:
*Completion of the treatment phase of the two Phase III trials with
Miraxion in Huntington's disease
*US patent granted for Miraxion to treat Huntington's disease
*Acquisition of global rights to a novel oral formulation of apomorphine
*Listings obtained on London and Irish stock exchanges
*Scientific Advisory Board formed
*Presentation of promising preclinical data on Miraxion at American
Academy of Neurology
*Demonstration of Miraxion mechanism of action in depression
*Dr. John Climax appointed to the Board as a non-executive director
*Gross proceeds of $25.0 million raised from equity financings
KEY HIGHLIGHTS
* Completion of the treatment phase of the US and EU Phase III clinical
trials with Miraxion in Huntington's disease - as announced on February 5,
Amarin completed the treatment phase of the two trials, involving more than
600 patients, representing the largest therapeutic programme in HD ever
conducted.
* Patent granted in the United States for Miraxion in Huntington's
disease - October 2006, the United States Patent and Trademark Office
granted approval for the patent application covering the use of
proprietary ultra-pure ethyl-EPA compound ("Miraxion") in Huntington's
disease. The patent was approved on October 11, 2006 and will run to
2021.
* Acquisition of global rights to a novel oral formulation of apomorphine
- May 2006, Amarin acquired the global rights to a novel oral formulation of
apomorphine for the treatment of "off" episodes in patients with advanced
Parkinson's disease. The objective of this novel oral formulation is to
provide rapid absorption of apomorphine directly into the blood stream after
sublingual (under the tongue) administration. This novel formulation would
offer patients an improved alternative to the currently available injectable
formulation of apomorphine.
* Listings obtained on London and Irish stock exchanges - July 2006,
Amarin obtained secondary listings on the AIM market of the London Stock
Exchange and the IEX market of the Irish Stock Exchange. 's primary
listing is on the Nasdaq Stock Market.
* Scientific Advisory Board ("SAB") formed - May 2006, Amarin's
SAB will serve to counsel Amarin on evaluating new product
opportunities, guiding on clinical and regulatory pathways, and
advising on the significance of new scientific and clinical results
from Amarin's research programs.
* Presentation of promising preclinical data at AAN - April
2006, Professor Cai Song, M.D., Ph.D presented two posters of
data from two pre-clinical studies of Miraxion at the 58th
Annual American Academy of Neurology Conference. The studies
demonstrated that Miraxion improved learning and memory, had
multiple neuroprotective effects and improved cell viability,
thereby slowing neuronal apoptosis (cell death) which is often
associated with a number of neurodegenerative disorders such as
Alzheimer's, Parkinson's and Huntington's diseases.
* Demonstration of Miraxion mechanism of action in depression - March
2006, an investigation conducted by Professor MV Bermejo, Department of
Pharmaceutics, University of Valencia, Spain reported that pre-clinical data
demonstrated that Miraxion may improve stress hormone (such as cortisol)
transport through the blood brain barrier.
* Board Appointment - March 2006, Dr. John Climax was appointed to
Amarin's board as non-executive director. Dr. Climax is a founder and
executive chairman of ICON plc and has over 25 years of experience in the
pharmaceutical industry.
* Equity Financing - gross proceeds raised of approximately $25.0
million during 2006.
DEVELOPMENT PIPELINE UPDATE
Huntington's Disease
Patients, having completed the treatment phase of the two Phase III
trials mentioned above, may now switch to an open label study where they
will receive Miraxion. Headline data from the trials will be available
in mid-second quarter 2007. An earlier Phase III trial identified
Huntington's disease patients with specific genetic characteristics,
representing approximately 70% of the patient population, who responded
to Miraxion.
Depression
Miraxion has been shown to provide clinical benefits to patients in six
separate Phase II trials in a variety of depressive disorders. Further
analysis of three Amarin led studies demonstrated a positive response
with Miraxion in patients suffering from melancholic depression, one of
two subtypes of major depression recognized by the Diagnostic and
Statistical Manual of Mental Disorders (DSM-IV), the main diagnostic
reference of mental health professionals in the United States (published
by the American Psychiatric Association, Washington D.C.).
Amarin intends to conduct an optimally designed Phase II trial
specifically in melancholic depression patients taking into account
advice obtained from key opinion leaders. The trial design, which will
involve biomarker and efficacy endpoints, is near completion and Amarin
expects its commencement within the next four months. It is estimated
that there are approximately one million patients in the United States
suffering from melancholic depression with limited treatment options and
that the market opportunity is in the order of $2 billion to $4 billion
globally.
Parkinson's Disease
Further research over the past 18 months into Miraxion's mechanism of
action has expanded our understanding of its potential benefit in
treating a number of neurological diseases including Parkinson's
disease. Amarin is now planning to commence a Phase II neuro-imaging
study with Miraxion in Parkinson's disease patients. The study will be
conducted at the John Radcliffe hospital in Oxford, England. The study
will use functional magnetic resonance imaging techniques to identify
both function and activity in the nigrostriatal pathway of Parkinson's
patients taking Miraxion. Amarin is preparing to request regulatory
approvals for trial commencement which is expected for the second
quarter of this year.
Amarin's novel sub-lingual formulation of apomorphine for the treatment
of "off" periods in advanced Parkinson's patients completed a proof of
concept study last year which demonstrated oral bioavailability of
apomorphine. A pharmacokinetic study using several different oral
apomorphine formulations was commenced towards the end of 2006. Data
from this pharmacokinetic study is currently being evaluated. This trial
is intended to identify the differing absorption characteristics from
the formulations in order to identify a compound to optimize with a view
to commencing a Phase II efficacy study in Parkinson's patients later
this year.
Combinatorial Lipid Programme
Amarin's novel and proprietary combinatorial lipid technology platform
combines bioactive lipids with other lipids or other chemical entities
to create new and patentable single chemical entities. By conjugating
bioactive lipids with other lipids or existing drugs Amarin is able to
develop compounds with potentially unique bioavailability and absorption
characteristics in the brain. Two such compounds have entered
pre-clinical development for Parkinson's disease and may report
preliminary results later in 2007, with an objective of bringing at
least one compound into clinical development in 2008.
FINANCIAL RESULTS
For the quarter ended December 31, 2006, Amarin's operating loss was
$8.2 million, compared with an adjusted operating loss of $5.9 million
for the same period in 2005. For the year ended December 31, 2006,
Amarin reported an operating loss of $31.2 million, compared with an
adjusted operating loss of $20.7 million for 2005. The increase for the
quarter and the year is primarily due to higher research and development
costs. Please see note 4 to the selected financial data below for
discussion on the adoption of FRS 20 regarding the expensing of
share-based compensation and its impact on the results for 2006 and
2005.
Research and development costs reflect third party research contract
costs, staff costs, preclinical study costs, clinical supplies and the
costs of conducting clinical trials. The increase for the fourth quarter
and for the year when compared to the comparative periods of 2005 is
primarily due to the costs of the two Phase III trials with Miraxion in
Huntington's disease and the development costs associated with our novel
oral formulation of apomorphine for advanced Parkinson's disease.
Selling, general and administrative costs primarily represent Amarin's
general corporate overhead, the Company's substantial investment in
intellectual property and the business and corporate development costs
of pursuing its growth strategy, including the costs of evaluating
potential in-licensing and acquisition opportunities. Selling, general
and administrative costs (excluding amortisation charges, restructuring
costs and share-based compensation charges) for the fourth quarter 2006
of $2.9 million increased by $0.3 million when compared to the same
period in 2005. For the full year, selling, general and administrative
costs of $11.8 million increased by $2.0 million when compared to 2005.
The increase for the quarter and the full year was primarily due to
increased professional fees and staff costs.
Revenue of $0.4 million and $0.5 million for the fourth quarter and the
full year respectively represents payments received from Multicell Inc.
Amarin licensed the rights to MCT-125 (formerly LAX-202) to Multicell in
2005. Multicell intends to commence a Phase IIb trial with MCT-125 for
the treatment of fatigue in multiple sclerosis in 2007.
Cash Position
At December 31, 2006, Amarin had cash of $36.8 million compared to $33.9
million at December 31, 2005. The increase in cash balances is primarily due
to the proceeds raised from financing activities in January, March and
October 2006, and license fees received from Multicell less cash outflows
during the period.
In January and March 2006, Amarin raised gross proceeds of approximately $2.1
million and $4.2 million respectively. During the quarter, on October 23, 2006,
Amarin concluded a registered direct offering of approximately 9.0 million
ordinary shares to both new and existing institutional and other accredited
investors which raised gross proceeds of $18.7 million. Together these three
transactions raised gross proceeds of approximately $25.0 million, including
$1.2 million from directors and officers of the company.
Amarin has no debt other than working capital liabilities. Based upon current
business activities, we forecast having sufficient cash to fund operations for
at least the next 12 months and potentially beyond depending on the outcome of
Miraxion's Phase III trials in Huntington's disease and/or the partnering
activities ongoing with our development pipeline.
At January 31, 2007, Amarin had 90.7 million ordinary shares in issue and
options and warrants outstanding to purchase 19.0 million shares.
CONFERENCE CALL
Amarin management will host a conference call to discuss these results at 8:30
a.m., Eastern Standard Time, 1:30 p.m., Greenwich Mean Time, on Thursday,
February 8, 2007. To participate in the call, please dial (800) 968 7995 (toll
free) in the US or +1 (706) 679 8403 (toll) elsewhere. The conference ID is
7774188. A telephone replay will be available shortly after the conference call
through 12:00 Midnight, Eastern Standard Time, on Monday, May 8, 2007, on the
link on the company's website www.amarincorp.com or by dialling (800) 642 1687
(tollfree) in the US or +1 (706) 645 9291 (toll) elsewhere, and entering the
access code 7774188. In addition, the call will also be webcast live and a link
will be on the company's website at www.amarincorp.com. Information on the
company's website is not part of this press release.
About Amarin
Amarin is committed to improving the lives of patients suffering from diseases
of the central nervous system. Our goal is to be a leader in the research,
development and commercialization of novel drugs that address unmet patient
needs.
Amarin has a late-stage drug development pipeline. Miraxion, Amarin's lead
development compound, is in Phase III development for Huntington's disease
("HD"), Phase II development for depressive disorders and is planned to enter
Phase IIa development for Parkinson's disease. Amarin's core development
pipeline also includes the global rights to a novel oral formulation of
apomorphine for treating patients with advanced Parkinson's disease.
Miraxion for HD is being developed under a Special Protocol Assessment agreed
with the United States Food and Drug Administration ("FDA"), has been granted
Fast Track designation by the FDA and has received Orphan Drug designation in
the US and Europe.
Amarin maintains its primary stock market listing in the United States on the
Nasdaq Stock Market ("AMRN") and secondary listings in the United Kingdom and
Ireland on AIM ("AMRN") and IEX ("H2E") respectively.
For press releases and other corporate information, visit the Amarin website at
http://www.amarincorp.com. Information on our website does not form part of this
press release.
Contacts:
Amarin +44 (0) 207 907 2442
Rick Stewart Chief Executive Officer
Alan Cooke Chief Financial Officer
investor.relations@amarincorp.com
Investors:
Lippert/Heilshorn & Associates, Inc. +1 212 838 3777
Kim Golodetz
Anne Marie Fields
Media:
Powerscourt +44 (0) 207 236 5615
Rory Godson
Victoria Brough
Disclosure Notice:
The information contained in this document is as of February 8, 2007. Amarin
assumes no obligation to update any forward-looking statements contained in this
document as a result of new information or future events or developments. This
document contains forward-looking statements about Amarin's financial condition,
results of operations, business prospects and products in research that involve
substantial risks and uncertainties. You can identify these statements by the
fact that they use words such as "will", "anticipate", "estimate", "expect",
"project", "forecast", "intend", "plan", "believe" and other words and terms of
similar meaning in connection with any discussion of future operating or
financial performance or events. Among the factors that could cause actual
results to differ materially from those described or projected herein are the
following: the success of Amarin's research and development activities,
including the Phase III trials with Miraxion in Huntington's disease; decisions
by regulatory authorities regarding whether and when to approve Amarin's drug
applications, as well as their decisions regarding labeling and other matters
that could affect the commercial potential of Amarin's products; the speed with
which regulatory authorizations, pricing approvals and product launches may be
achieved; the success with which developed products may be commercialized;
competitive developments affecting Amarin's products under development; the
effect of possible domestic and foreign legislation or regulatory action
affecting, among other things, pharmaceutical pricing and reimbursement,
including under Medicaid and Medicare in the United States, and involuntary
approval of prescription medicines for over-the-counter use; Amarin's ability to
protect its patents and other intellectual property; claims and concerns that
may arise regarding the safety or efficacy of Amarin's product candidates;
governmental laws and regulations affecting Amarin's operations, including those
affecting taxation; Amarin's ability to maintain sufficient cash and other
liquid resources to meet its operating requirements; general changes in UK and
US generally accepted accounting principles; growth in costs and expenses; and
the impact of acquisitions, divestitures and other unusual items, including
Amarin's ability to integrate its acquisition of Amarin Neuroscience Limited. A
further list and description of these risks, uncertainties and other matters can
be found in Amarin's Annual Report on Form 20-F for the fiscal year ended
December 31, 2005, as amended by Form 20-F/A filed on October 13, 2006, and in
its Reports of Foreign Issuer on Form 6-K furnished to the SEC.
Amarin Corporation plc
Period Ended 31 DECEMBER 2006 Selected Data (UK GAAP - UNAUDITED)
Three months ended 31 Dec Twelve months ended 31 Dec
Total Total Total Total
$'000 $'000 $'000 $'000
Revenue 400 500 500 500
Gross profit 400 500 500 500
Operating expenses:
Research and
development 5,051 2,419 16,460 8,313
Selling, general &
administrative 2,891 2,584 11,793 9,767
Amortisation of
intangible assets 170 169 676 676
Group
restructuring - 652 531 652
Share-based
compensation
(non-cash) 470 575 2,201 1,840
--------- --------- --------- ---------
Operating expenses 8,582 6,399 31,661 21,248
Total research &
development 5,206 2,609 17,186 8,920
Total selling,
general &
administrative 3,376 3,790 14,475 12,328
--------- --------- --------- ---------
Total operating
expenses 8,582 6,399 31,661 21,248
--------- --------- --------- ---------
Operating loss on
ordinary
activities before
interest (8,182) (5,899) (31,161) (20,748)
Net interest
receivable/(payabl
e) and similar
credits/(charges) 1,555 (39) 3,442 (497)
--------- --------- --------- ---------
Loss before taxes (6,627) (5,938) (27,719) (21,245)
Income tax credit 128 163 799 698
Net loss for the
period (6,499) (5,775) (26,920) (20,547)
--------- --------- --------- ---------
Weighted average
shares - basic
('000) 88,326 54,085 82,337 46,590
Loss per share:
Basic (0.07) (0.11) (0.33) (0.44)
* See note 4
Amarin Corporation plc
Period Ended 31 DECEMBER 2006 Selected Data (UK GAAP - UNAUDITED)
-----------------
As at 31 Dec
-----------------
$'000 $'000
1. Selected Balance Sheet Data
Fixed assets
Tangible 282 460
Intangible 8,953 9,627
--------- --------
9,235 10,087
Current assets
Debtors 2,789 2,766
Cash 36,802 33,907
--------- --------
39,591 36,673
Creditors - due within one year (10,756) (8,000)
--------- --------
Net current assets 28,835 28,673
Creditors - due after one year (116) (165)
Provisions for liabilities and charges (119) (15)
--------- --------
Net assets 37,835 38,580
========= ========
Called up share capital 7,990 6,778
Reserves 29,845 31,802
--------- --------
Shareholders' funds 37,835 38,580
========= ========
2. The selected financial data set out above should be read in conjunction
with our 2005 Annual Report on Form 20-F (including risk factors described
therein) which is filed with the SEC.
3. Loss per share
Basic loss per share is calculated by dividing the net loss by the weighted
average number of shares in issue in the period. The Company reported a net
loss in the three months ended December 31, 2005 and 2006. As a result the
loss per share is not reduced by dilution from outstanding options and
warrants.
4. Share-based compensation
The operating loss includes $2.2 million for the period ended December 31,
2006 ($0.5 million in the quarter) in respect of non-cash compensation expense
due to the adoption of Financial Reporting Standard 20, effective January 1,
2006. The corresponding figure for the period ended December 31, 2005 is $1.8
million ($0.6 million for quarter ended December 31, 2005). The charge for the
quarter includes a credit of $0.1 million and the corresponding quarter in
2005 includes an additional expense of $0.2 million to reflect the year end
finalization of the share based payment calculations. The adoption of FRS 20
has no impact on the net assets of the Company.
5. Intangible fixed assets
At December 31, 2006, Miraxion had an intangible asset carrying value of $9.0
million, a decrease of $0.6 million from $9.6 million at December 31, 2005.
The decrease in carrying value arises from amortisation in the year.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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