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AMRN Amarin Corp

92.50
0.00 (0.00%)
19 Jul 2024 - Closed
Delayed by 15 minutes
Share Name Share Symbol Market Type Share ISIN Share Description
Amarin Corp LSE:AMRN London Ordinary Share GB00B29VL935 ORD 50P
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.00 0.00% 92.50 0.00 01:00:00
Industry Sector Turnover Profit EPS - Basic PE Ratio Market Cap
0 0 N/A 0

3rd Quarter Results

20/11/2007 1:25pm

UK Regulatory


RNS Number:1070I
Amarin Corporation Plc
20 November 2007



               AMARIN REPORTS THIRD QUARTER 2007 FINANCIAL RESULTS


       Conference Call at 8.30 a.m. Eastern Time Today, November 20, 2007


LONDON, United Kingdom, November 20, 2007 - Amarin Corporation plc (NASDAQ:
AMRN) ("Amarin" or "Company") today reported financial results for the third
quarter ended September 30, 2007 and an update on its development pipeline.


For the third quarter of 2007, Amarin reported a net loss of $5.9 million, or
$0.06 per share, compared with a net loss of $6.6 million, or $0.08 per share,
in the third quarter of 2006. The decrease for the third quarter from the
comparative period of 2006 is primarily due to the completion of the Phase III
trials with Miraxion earlier this year.


For the nine months ended September 30, 2007, Amarin reported a net loss of
$30.3 million or $0.32 per share, compared with a net loss of $21.7 million or
$0.27 per share for the nine months ended September 30, 2006. The increase in
the loss for the nine months compared to the comparative period in 2006 is
primarily due to the previously announced write off of the Miraxion intangible
asset of $8.8 million in the second quarter of 2007. Figures for the comparative
periods have been restated to International Financial Reporting Standards
("IFRS"). For further information with respect to the application of IFRS to our
accounts, please refer to our IFRS transition document available on our website
and furnished to the SEC on Form 6-K.


Rick Stewart, chief executive officer of Amarin, commented, "The third quarter
was extremely productive with the primary focus on clinical development
activities. We are now planning up to five Phase II clinical trials from our
high value neuroscience and cardiovascular programs over the next twelve months,
with two to start imminently. In addition, two key value drivers are the
initiation of our cardiovascular strategy and the announcement yesterday of the
FDA response to the comprehensive analysis of the longer term data from the
Huntington's disease Phase III trials."


PIPELINE UPDATE


Huntington's disease ("HD")


Amarin announced on November 19, 2007, that management has met with the U.S.
Food and Drug Administration (FDA) following the completion of a comprehensive
data review from its large-scale Phase III studies of Miraxion to treat HD. The
FDA indicated that one additional Phase III trial demonstrating robust results,
in conjunction with the confirmatory evidence from the existing clinical data,
may be sufficient clinical data to support a New Drug Application.


Amarin is in discussions with the Huntington Study Group to determine the
optimal design of such a single Phase III trial. Amarin is also considering
whether it will conduct this study itself or seek a collaborative partner with
which to advance Miraxion in HD.


Since the previous Company update on Miraxion on August 1, 2007, the Company has
continued a comprehensive analysis of all clinical data with its advisors. This
additional analysis supports the preliminary findings, suggesting a clinical
benefit from a longer treatment period for Miraxion. Further details are set out
in our press release of November 19, 2007.


Parkinson's disease - Two programs


Sublingual apomorphine


Amarin's novel, sublingual 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 to commence as soon as the necessary regulatory
approvals have been obtained. A Phase II study in Parkinson's patients is
planned to follow later in 2008.

Amarin's sublingual 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, 2007, 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 is currently evaluating the results of a recently
completed pre-clinical pharmacokinetic study. Subsequent refinement of the nasal
formulation for use in human trials is expected to be conducted. 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 double blind placebo controlled proof of concept
study with ultra-pure EPA in Age Associated Memory Impairment (AAMI) in patient
volunteers by year end. AAMI is one of the mildest forms of cognitive
dysfunction and is a recognized syndrome under DSM IV of the American
Psychiatric Association. People with AAMI experience deterioration in memory,
learning, attention, concentration, thinking, use of language and other mental
functions. 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.


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 triglyceride 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
triglycerides in patients with elevated baseline levels.


Amarin has initiated a cardiovascular development strategy to capitalize on the
known therapeutic benefits of unsaturated fatty acids in cardiovascular disease.
Amarin plans to utilize its extensive know-how and experience in lipid science
to develop a series of products targeting the vascular system, endothelial
dysfunction and vascular re-modeling.
Amarin is building on an extensive knowledge base in cardiovascular disease and
plans to leverage its expertise in lipid science to create new therapies from
its existing family of compounds.

Amarin is commencing a series of clinical trials with AMR 101 (97% pure EPA) in
dyslipidemia, the first of which will commence by the end of this year. In
addition, Amarin intends to commence investigation of new compounds from its
existing development portfolio for the treatment of metabolic syndrome and
dyslipidemia.


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 allows the chemical conjugation of
bio-active lipids with existing drugs to improve bioavailability, blood brain
barrier penetration and potentially to 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 September 30, 2007


For the quarter ended September 30, 2007, Amarin's operating loss was $6.9
million, compared with an operating loss of $7.6 million for the same period in
2006. The decrease for the quarter compared to the corresponding period in 2006
is primarily due to a reduction in research and development expenditure of $2.1
million offset by a higher stock compensation charge of $1.0 million.


Research and development costs of $2.2 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 third quarter of $2.1
million from the comparative period of 2006 is primarily due to the completion
of the Phase III trials with Miraxion earlier this year. Research and
development costs for the third quarter primarily represent expenditures on
Amarin's two Parkinson's disease programs, its epilepsy and memory programs and
some expenditure on the initiation of its new cardiovascular program.


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
third quarter 2007 of $3.1 million increased by $0.5 million when compared to
the same period in 2006. This increase is primarily due to increased personnel
and business development costs.


Selling, general and administrative costs decreased from $4.0 million and $3.8
million in the first and second quarters of 2007 respectively to $3.1 million
for the third quarter. The primary reason for this decrease is due to a
reduction in professional and advisor fees.


Non-cash share based compensation expense increased $1.0 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.


Nine months ended September 30, 2007


For the nine-month period ended September 30, 2007, Amarin reported an operating
loss of $33.0 million, compared with an operating loss of $21.4 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 $2.4 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. These
amounts are partly offset by a reduction in research and development costs.


Cash Position



As at September 30, 2007, Amarin had cash of $20.7 million compared to $36.8
million at December 31, 2006. Amarin has no debt other than working capital
liabilities and based on current business activities forecasts having sufficient
cash to fund the group's operating activities into September 2008.


For further information, see footnote 4 to the selected financial data below.


At September 30, 2007, Amarin had 97.8 million ordinary shares in issue and
options and warrants outstanding to purchase 22.0 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, November 20,
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 24477922. A
telephone replay will be available shortly after the conference call through 12:
00 Midnight, Eastern Daylight Time, on Wednesday, February 20, 2008, 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 24477922. 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 and cardiovascular diseases.  Our goal is to be a
leader in the research, development and commercialization of novel drugs that
address unmet patient needs.


Amarin's CNS development pipeline includes Miraxion for Huntington's disease,
two programs in Parkinsons's disease, one in epilepsy and one in memory and
cognition. Amarin is initiating a series of cardiovascular preclinical and
clinical programs to capitalize on the known therapeutic benefits of unsaturated
fatty acids in cardiovascular disease. Amarin also has a proprietary lipid-based
technology platform for the targeted transport of molecules through the liver
and/or to the brain that can be leveraged in a wide range of disease
applications for its own product pipeline or with potential partners.


Amarin has its primary stock market listing in the U.S. on NASDAQ ("AMRN") and
secondary listings in the U.K. 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 Meegan                            +353 (0) 1 679 6363



Disclosure Notice:


The information contained in this document is as of November 20, 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, including its planned
clinical trials in cardiovascular 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 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 SEPTEMBER 2007 Selected Data (IFRS - UNAUDITED)
                     --------------------               -------------------
                Three months ended 30 September    Nine months ended 30 September
                     Total              Total           Total             Total
                     $'000              $'000           $'000             $'000

Revenue                  -                100               -               100
                 -----------         ----------       ---------       ----------
                 -----------         ----------       ---------       ----------
Gross profit             -                100               -               100
                 -----------         ----------       ---------       ----------

Operating
expenses:
Research and
development          2,237              4,323           9,024            10,455
Selling,
General &
Administrative       3,112              2,636          10,887             8,795
Amortisation
of intangible
assets                   -                169             169               506
Impairment of
intangible
fixed
assets(non-cas
h)                       -                  -           8,784                 -
Share-based
compensation(n
on-cash)             1,541                565           4,136             1,731

Operating
expenses             6,890              7,693          33,000            21,487

Total research
& development        2,615              4,509           9,988            11,026
Total selling,
general &
administrative       4,275              3,184          23,012            10,461
                 -----------         ----------       ---------       ----------
Total
operating
expenses             6,890              7,693          33,000            21,487
                 -----------         ----------       ---------       ----------

Total
operating
(loss)              (6,890)            (7,593)        (33,000)          (21,387)

Finance income         821                839           2,021             1,811
Finance expense          -                  -               -            (2,826)
                 -----------         ----------       ---------       ----------
(Loss) before
taxes               (6,069)            (6,754)        (30,979)          (22,402)

Income tax
credit                 179                118             665               671
                 -----------         ----------       ---------       ----------
Net (loss) for
the period          (5,890)            (6,636)        (30,314)          (21,731)
                 -----------         ----------       ---------       ----------

Weighted
average
shares: -
basic               97,566             81,412          93,692            80,318
(Loss)/income
per share: -
Basic                (0.06)             (0.08)          (0.32)            (0.27)
Diluted              (0.06)             (0.08)          (0.32)            (0.27)

                                Amarin Corporation plc

            Period Ended 30 SEPTEMBER 2007 Selected Data (IFRS - UNAUDITED)
                                                     -------------       -------------
                                                         As at 30            As at 31
                                                         September           December
                                                     -------------       -------------
                                                      -------------       -------------
                                                            $'000               $'000
1. Selected Balance Sheet Data
Assets
Non-current assets
Property, plant and equipment                                 635                 314
Intangible fixed assets                                         -               9,636
Available for sale investment                                  22                  18
                                                      -------------       -------------
                                                              657               9,968
Current assets
Income tax recoverable                                      1,571               1,617
Other current assets                                        1,753               1,172
Cash                                                       20,735              36,802
                                                      -------------       -------------
Total current assets                                       24,059              39,591
                                                      -------------       -------------
Total assets                                               24,716              49,559
                                                      =============       =============

Liabilities
Non-current liabilities
Provisions                                                      -                 119
Other liabilities                                              85                 116
                                                      -------------       -------------
Total non-current liabilities                                  85                 235

Current liabilities
Trade payables                                              1,832               2,096
Accrued expenses & other
liabilities                                                 6,637               8,660
                                                      -------------       -------------
Total current liabilities                                   8,469              10,756
                                                      -------------       -------------
Total liabilities                                           8,554              10,991
                                                      -------------       -------------

Equity
Capital and reserves attributable to equity holders
Share capital                                               8,691               7,990
Other reserves                                              7,471              30,578
                                                      -------------       -------------
Total shareholders' equity and
liabilities                                                24,716              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 September 30, 2006 and 2007. As a result the 
loss per share is not reduced by dilution from outstanding options and warrants.

4. Going Concern Basis
As at September 30, 2007, Amarin had cash of $20.7 million compared to $36.8 
million at December 31, 2006. Amarin has no debt other than working capital 
liabilities and based on current business activities forecasts having 
sufficient cash to fund the group's operating activities into September 2008.
Amarin intends to obtain additional funding through earning licensing fees 
from its partnering activities and/or completing further financings. There is 
no assurance that Amarin's efforts to raise additional funding will be 
successful. If efforts are unsuccessful, there is uncertainty as to whether 
Amarin will be able to fund its business through the third quarter of 2008 and 
beyond. These selected data do not include any adjustments that might be 
necessary should such funding not be available. Amarin believes it will be 
successful in obtaining further funds as described above and the directors 
have therefore presented the selected data on a going concern basis.


                      This information is provided by RNS
            The company news service from the London Stock Exchange

END
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