RNS Number:3370B
Amarin Corporation Plc
01 August 2007
AMARIN REPORTS SECOND QUARTER 2007 FINANCIAL RESULTS
Provides Miraxion and Pipeline Update
Conference Call at 8.30 a.m. Eastern Time Today, August 1, 2007
LONDON, United Kingdom, August 1, 2007 - Amarin Corporation plc (NASDAQ: AMRN)
("Amarin" or "Company") today reported:
*financial results for the second quarter ended June 30, 2007
*an update on its phase III trials in Huntington's disease with Miraxion
and
*progress with its development pipeline.
For the second quarter of 2007, Amarin reported a net loss of $15.6 million, or
$0.17 per share, compared with a net loss of $6.1 million, or $0.08 per share,
in the second quarter of 2006. For the six months ended June 30, 2007, Amarin
reported a net loss of $24.4 million or $0.27 per share, compared with a net
loss of $15.1 million or $0.19 per share for the six months ended June 30, 2006.
The increased losses in the periods were primarily due to the previously
announced write off of the Miraxion intangible asset of $8.8 million (described
further below).
Rick Stewart, chief executive officer of Amarin, commented on Amarin's phase III
program in Huntington's disease with Miraxion, "The six-month results previously
announced from our two phase III trials in Huntington's disease triggered
significant data analysis and evaluation which is ongoing and targeted for
completion in the fourth quarter. Preliminary analysis of the 12-month data
suggests that there may be a benefit for Huntington's disease patients from a
longer treatment period with Miraxion, particularly the specific genetic patient
group that was targeted in these trials. This is similar to the encouraging
findings from the long term open label study from our earlier trial with
Miraxion. However, the viability of our Huntington's disease program remains
uncertain until we have completed the full analysis and evaluation of the
complex set of trial data."
Mr Stewart continued, "I am pleased to report that we have made substantial
progress with the rest of our development pipeline. We are currently developing
a cardiovascular strategy to capitalize on the known clinical benefits of EPA in
this area. EPA-based prescription drugs, like Miraxion, are already approved in
the U.S. and Japan for the treatment of cardiovascular disease. We plan to
disclose further information on our cardiovascular strategy later this year. In
addition, our other four key development programs in Parkinson's disease,
epilepsy seizures, memory and cognition have all made significant progress and
are planned to reach important development milestones in the next six months."
PIPELINE UPDATE
Huntington's disease ("HD")
Amarin continues to analyze and evaluate the substantial amount of data
generated from its two Phase III clinical trials of Miraxion in HD. On April 24,
2007, Amarin announced top-line results from both studies at six months that
showed no statistically significant difference in efficacy between Miraxion and
placebo. The primary endpoint of the trials was a change in the Total Motor
Score 4 (TMS-4) component of the Unified Huntington's Disease Rating Scale at
six months.
The U.S. trial was prospectively designed as a 12-month study, with a six-month,
double-blind, placebo-controlled treatment period followed by a further
six-month, open label extension period where all patients received Miraxion. In
total, 190 patients had completed their 12-month assessments by the time the
six-month results were announced and the trial halted. The E.U. trial commenced
later than the U.S. trial and a meaningful number of patients had not received
12 months of treatment when the trial was halted.
In excess of 600,000 data points were generated during the trials which require
analysis, correlation and evaluation. Amarin is carrying out this analysis,
which is incomplete, with the aid of the Huntington's Study Group ("HSG") and
the European HD network ("Euro HD").
Preliminary indications suggest that patients who were treated with Miraxion for
12 months on average showed no deterioration of the primary endpoint (TMS-4) in
the overall patient group. In addition, a genetic sub-group of patients - those
with a CAG repeat length of less than 45 - on average displayed an improvement
in TMS-4. It was this specific genetic group of patients that was targeted as
potential responders to Miraxion, based upon clinical data from an earlier
trial.
These preliminary findings are similar to the encouraging open label data seen
at 24-months following the earlier 135 patient phase III trial. The 24-month
data was recently presented at the 11th International Congress of The Movement
Disorders Society, Istanbul.
However, the viability of the program will remain uncertain until the full
analysis of this complex data is complete. Amarin continues to analyze and
evaluate the full data from the two trials with the HSG, Euro HD and our
advisors. The Company also intends to pursue discussions with the U.S. Food and
Drug Administration and European Agency for the Evaluation of Medical Products.
Further information should be forthcoming later this year, likely in the fourth
quarter.
Miraxion was found to be safe and well tolerated by patients.
Cardiovascular disease
The clinical benefit of EPA-based drugs to treat cardiovascular disease is well
recognized. A Japanese prescription drug, identical to Miraxion (ultra pure
EPA), is approved and marketed for trygliceride lowering. In the U.S., an
EPA-based prescription drug is also approved and marketed for this indication.
In the most recent HD trials, Miraxion, as expected, was shown to lower
tryglicerides in patients with elevated baseline levels. Amarin is currently
developing a cardiovascular strategy to capitalize on the known clinical
benefits of EPA. Further information will be disclosed in the fourth quarter.
Parkinson's disease - Two programs
Oral apomorphine
Amarin's novel, oral formulation of apomorphine for the treatment of "off"
episodes in advanced Parkinson's patients completed a second pharmacokinetic
study in volunteers earlier this year. This study compared the pharmacokinetic
characteristics of four different formulations of oral apomorphine. The lead
formulation has now been selected for optimization and a final pharmacokinetic
study in volunteers is planned for the fourth quarter. A Phase II study in
Parkinson's patients is expected to begin in early 2008.
Amarin's novel, oral formulation provides rapid absorption of apomorphine
directly into the bloodstream after sublingual (under the tongue)
administration. This novel formulation would offer patients an improved
alternative to the currently available injectable formulation of apomorphine
that can be associated with the formation of painful swellings at the site of
administration.
Combinatorial lipid formulation of levodopa
Pre-clinical results from Amarin's combinatorial-levodopa development program
are encouraging. Initial results show substantially increased brain levels of
dopamine compared to control in pre-clinical models. Additional pre-clinical
studies are ongoing. Clinical trials are planned to commence next year. Levodopa
is the "gold standard" for the alleviation of Parkinson's disease symptoms,
accounting for 70% of the prescription market.
Epilepsy Seizures
In February, Amarin in-licensed the global rights to a novel, nasal lorazepam
formulation for the out-patient treatment of emergency seizures in epilepsy
patients, specifically status epilepticus ("SE") and acute repetitive seizures
("ARS"). Amarin's nasal lorazepam will complete a pre-clinical pharmacokinetic
study during the third quarter. Subsequent refinement of the nasal formulation
is expected to be conducted on completion of this study. Clinical studies are
planned to commence next year.
Intravenous lorazepam is a first line of treatment for SE and ARS in hospital
emergency rooms in the United States. A nasal lorazepam product for seizure
emergencies in the out-patient setting would represent an important treatment
alternative for epilepsy patients. Diazepam rectal gel is the only treatment
currently approved by the U.S. Food and Drug Administration ("FDA") for seizure
emergencies in the out-patient setting. Diazepam gel's use is limited by its
rectal route of administration. Consequently, an opportunity exists for the
development of a product with a more convenient route of administration
permitting broader out-patient treatment of SE and ARS in both children and
adults.
Memory and Cognition
Amarin intends to commence a proof of concept study in humans with ultra-pure
EPA in memory and cognition in the fourth quarter. Data generated by the
Institute of Neuroscience at Trinity College, Dublin, Ireland supports the use
of ultra-pure EPA in pre-clinical models of memory and cognition.
Combinatorial Lipid Program
In addition to the targeted transport of levodopa to treat Parkinson's patients
discussed above, Amarin has several targeted transport projects under
evaluation. As these programs progress, further details will be disclosed.
Amarin's targeted transport technology chemically conjugates bio-active lipids
with either other lipids or existing drugs to improve bioavailability, blood
brain barrier penetration and potentially increase efficacy, while reducing side
effects. Each conjugate will be a new chemical entity ("NCE") with the potential
for new intellectual property. The application of this platform is not limited
to neurology, as it has applicability across a range of indications from
cardiovascular to oncology.
FINANCIAL RESULTS
Three months ended June 30, 2007
For the quarter ended June 30, 2007, Amarin's operating loss was $16.4 million,
compared with an operating loss of $7.2 million for the same period in 2006. The
increase for the quarter is primarily due to the previously announced write off
of the Miraxion intangible asset of $8.8 million (described further below), an
increase in selling, general and administration costs of $0.9 million and a
higher stock compensation charge of $0.6 million. These adverse variances were
offset by a reduction in research and development expenditure of $0.9 million.
Research and development costs of $2.4 million reflect third party research
contract costs, staff costs, preclinical study costs, clinical supplies and the
costs of conducting clinical trials. The decrease for the second quarter of $0.9
million from the comparative period of 2006 is primarily due to the completion
of the two Phase III trials with Miraxion in Huntington'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 for the
second quarter 2007 of $3.8 million increased by $0.9 million when compared to
the same period in 2006. The increase is primarily due to increased personnel
costs and the significant level of business development activity during the
quarter.
Non-cash share based compensation expense increased $0.6 million to $1.5 million
when compared to the same period in 2006. This increase was due to options
granted since the end of the comparative period.
Impairment of intangible assets
As previously reported, intangible assets of $8.8 million were written off
during the quarter. While Miraxion may have potential value in Huntington's
disease, central nervous system disorders and other therapeutic indications, due
to the six month trial results of the Phase III trials, it was deemed
appropriate to write off the intangible asset, all of which relates to Miraxion.
Six months ended June 30, 2007
For the six-month period ended June 30, 2007, Amarin reported an operating loss
of $26.1 million, compared with an operating loss of $13.8 million for the
comparative period in 2006. The increase in operating loss over 2006 is mainly
due to the $8.8 million impairment of intangible assets, an increase in share
based compensation expenses of $1.4 million and increased selling, general and
administration costs, primarily reflecting increased personnel costs and the
significant level of business development activities to date this year.
Cash Position
At June 30, 2007, Amarin had cash of $27.6 million compared to $29.0 million at
March 31, 2007. During the quarter, Amarin raised gross proceeds of $3.7 million
of which $0.7 million was invested by directors and officers of the Company. In
June 2007, Amarin entered into an equity line of credit agreement that provides
Amarin with the option to draw down up to a total of $15.0 million of additional
equity funding from time to time. The net decrease in cash balances is due to
operating cash outflows during the period.
Amarin has no debt other than working capital liabilities. Amarin forecasts
having sufficient cash to fund its operations through August 2008.
At June 30, 2007, Amarin had 97.8 million ordinary shares in issue and options
and warrants outstanding to purchase 21.3 million shares.
CONFERENCE CALL
Amarin management will host a conference call to discuss these results at 8:30
a.m., Eastern Daylight Time, 1:30 p.m., Greenwich Mean Time, today, August 1,
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 10049924. A
telephone replay will be available shortly after the conference call through 12:
00 Midnight, Eastern Daylight Time, on Monday, October 1, 2007, via the link on
the company's website at 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 10049924. 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's core development pipeline includes, in addition to Miraxion for several
therapeutic indications, four other key development programs in Parkinson's
disease, epilepsy seizures, memory and cognition and our proprietary
pre-clinical combinatorial lipid program.
Amarin has its primary stock market listing in the US on the Nasdaq Capital
Market ("AMRN") and secondary listings in the UK 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 President and Chief Financial Officer
investor.relations@amarincorp.com
Investors:
Lippert/Heilshorn & Associates, Inc. +1 212 838 3777
Anne Marie Fields
Bruce Voss +1 310 691 7100
Media:
Powerscourt +44 (0) 207 250 1446
Rory Godson
Sarah Daly
Broker:
Davy
Fergal Meehan +353 (0) 1 679 6363
Disclosure Notice:
The information contained in this document is as of August 1, 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: risks relating to the Company's ability to maintain its Nasdaq
listing (including the risk that the Company may not be able to achieve
compliance with the Nasdaq minimum bid price and/or other continued listing
criteria within the required timeframe or at all and the risk that the Company
may not be able to successfully appeal a Nasdaq delisting determination); the
success of Amarin's research and development activities; decisions by regulatory
authorities regarding whether and when to approve Amarin's drug applications, as
well as their decisions regarding 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 International and US generally
accepted accounting principles; growth in costs and expenses; and the impact of
acquisitions, divestitures and other unusual items. A further list and
description of these risks, uncertainties and other matters can be found in
Amarin's Form 20-F for the fiscal year ended December 31, 2006, filed with the
SEC on March 5 2007, Amarin's statutory annual report for the year ended 31
December, 2006 furnished on a Form 6-K to the SEC on May 9, 2007 and in its
Reports of Foreign Issuer on Form 6-K furnished to the SEC.
Amarin Corporation plc
Period Ended 30 JUNE 2007 Selected Data (IFRS - UNAUDITED)
----------------- -----------------
Three months ended 30 June Six months ended 30 June
----------------- -----------------
--------- --------- --------- ---------
Total Total Total Total
$'000 $'000 $'000 $'000
Revenue - - - -
--------- --------- --------- ---------
--------- --------- --------- ---------
Gross profit - - - -
--------- --------- --------- ---------
Operating expenses:
Research and
development 2,409 3,341 6,787 6,132
Selling, General &
Administrative 3,779 2,861 7,775 6,159
Amortisation of
intangible assets - 168 169 337
Impairment of
intangible fixed
assets(non-cash) 8,784 - 8,784 -
Share-based
compensation(non-cash) 1,465 817 2,595 1,166
Operating expenses 16,437 7,187 26,110 13,794
Total research &
development 2,756 3,611 7,373 6,517
Total selling,
general &
administrative 13,681 3,576 18,737 7,277
--------- --------- --------- ---------
Total operating
expenses 16,437 7,187 26,110 13,794
--------- --------- --------- ---------
Total operating
(loss) (16,437) (7,187) (26,110) (13,794)
Finance income 648 935 1,200 972
Finance expense - (6) - (2,826)
--------- --------- --------- ---------
(Loss) before taxes (15,789) (6,258) (24,910) (15,648)
Income tax credit 169 163 486 553
--------- --------- --------- ---------
Net (loss) for the
period (15,620) (6,095) (24,424) (15,095)
--------- --------- --------- ---------
Weighted average
shares - basic 92,948 81,202 91,723 79,763
(Loss)/income per share:
Basic (0.17) (0.08) (0.27) (0.19)
Diluted (0.17) (0.08) (0.27) (0.19)
Amarin Corporation plc
Period Ended 30 JUNE 2007 Selected Data (IFRS - UNAUDITED)
-------- --- -------- --- --------
As at 30 As at 31 As at 31 Dec
June March --------
-------- --------
-------- -------- --------
$'000 $'000 $'000
1. Selected Balance Sheet Data
Assets
Non-current assets
Property, plant
and equipment 643 632 314
Intangible fixed
assets - 9,480 9,636
Available for sale
investment 24 20 18
-------- -------- --------
667 10,132 9,968
Current assets
Income tax
recoverable 1,363 1,169 1,617
Other current
assets 1,434 1,216 1,172
Cash 27,610 28,969 36,802
-------- -------- --------
Total current
assets 30,407 31,354 39,591
-------- -------- --------
Total assets 31,074 41,486 49,559
======== ======== ========
Liabilities
Non-current liabilities
Provisions - 81 119
Other liabilities 92 99 116
-------- -------- --------
Total non-current
liabilities 92 180 235
Current liabilities
Trade payables 2,324 1,435 2,096
Accrued expenses &
other liabilities 7,919 8,767 8,660
-------- -------- --------
Total current
liabilities 10,243 10,202 10,756
-------- -------- --------
Total liabilities 10,335 10,382 10,991
-------- -------- --------
Equity
Capital and reserves attributable to equity holders
Share capital 8,691 7,991 7,990
Other reserves 12,048 23,113 30,578
-------- -------- --------
Total
shareholders'
equity and
liabilities 31,074 41,486 49,559
======== ======== ========
2. The selected financial data set out in this press release should be read in
conjunction with our 2006 20-F which was filed with the SEC on March 5, 2007
and our 2006 Statutory Annual Report (including risk factors described therein)
which was furnished on a Form 6-K to the SEC on May 9, 2007 and our IFRS
transition document also furnished on a Form 6-K to the SEC on May 9, 2007.
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 June 30, 2006 and 2007. As a
result the loss per share is not reduced by dilution from outstanding
options and warrants.
4. Intangible assets
As previously reported, on April 24, 2007 Amarin announced results from its
Phase III clinical trials which showed no statistically significant difference
between Miraxion and placebo with regard to primary and secondary endpoints.
While Miraxion may have potential value in central nervous system disorders
and other therapeutic indications, due to the 6-month results of the Phase III
trials, it was deemed appropriate to write off the intangible asset, all of
which relates to Miraxion. This non-cash write off occured in April 2007 and
increased the net loss and reduced net assets of the group by $8.8 million
and $9.5 million respectively.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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