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Amarin Reports Third Quarter 2012 Financial Results and Provides Update on Operations



Amarin Reports Third Quarter 2012 Financial Results and Provides Update on
Operations

Conference Call Set for 4:30 p.m. EST Today

BEDMINSTER, N.J. and DUBLIN, Ireland, Nov. 8, 2012 (GLOBE NEWSWIRE) -- Amarin
Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the
commercialization and development of therapeutics to improve cardiovascular
health, today announced financial results for the quarter ended September 30,
2012 and provided an update on company operations.

Amarin noted the following highlights of progress made since the quarter ended
June 30, 2012:

  * FDA approval of Vascepa^TM (icosapent ethyl) capsules as an adjunct to
    diet to reduce triglyceride (TG) levels in adult patients with severe
    (TG≥500 mg/dL) hypertriglyceridemia
  * Eight patents either issued or allowed with the United States Patent and
    Trademark Office, in addition to over 30 other U.S. patent applications
    pending
  * Receipt of Intention to Grant letter for a European patent related to the
    MARINE Phase 3 trial findings
  * While evaluating three paths to commercialization (an acquisition of
    Amarin, a strategic collaboration, or self-commercialization, the latter
    of which could include third-party support), continued preparedness for
    early Q1 2013 Vascepa launch, including inventory purchases, managed care
    outreach and management expansion
  * Publication of ANCHOR Phase 3 trial results in The American Journal of
    Cardiology
  * Publication of additional MARINE Phase 3 trial results in the Journal of
    Clinical Lipidology
  * Presentation of Vascepa Phase 3 clinical data at the American Heart
    Association Scientific Sessions
  * Regulatory approval of Catalent as second drug product encapsulator
  * REDUCE-IT cardiovascular outcomes study enrollment progress on track,
    which continues to support the projected Prescription Drug User Fee Act
    (PDUFA) action date for the ANCHOR indication before the end of 2013
  * Cash balance of $215.1 million at September 30, 2012

"Our recent regulatory affairs and intellectual property progress has been
significant, including our first U.S. marketing approval of Vascepa and an
increase in U.S. patents granted or allowed to 8 and more than 30 additional
applications being prosecuted," stated Joseph Zakrzewski, Amarin's Chairman
and Chief Executive Officer. "In parallel, whether Amarin launches through a
third party or on its own, commercial preparations for Vascepa have advanced
and we remain confident, based on market feedback, that Vascepa will be well
received when launched in early Q1 2013. We are very pleased with the approved
label for our initial launch and believe that Vascepa has the potential to
redefine lipid management."

Operational update

Vascepa regulatory update

On July 26, 2012, the U.S. Food and Drug Administration (FDA) approved Vascepa
(icosapent ethyl) capsules (formerly known as AMR101) as an adjunct to diet to
reduce triglyceride (TG) levels in adult patients with severe (TG >500mg/dL)
hypertriglyceridemia. The only reported adverse reaction with an incidence >2%
and greater than placebo in Vascepa treated patients was arthralgia (2.3% for
Vascepa, 1.0% for placebo). The approved label shows that Vascepa, compared to
placebo, reduces TG's, Apo B, non-HDL-C, total cholesterol and VLDL-C without
increasing LDL-C.

Amarin expects to file sNDAs for two additional active pharmaceutical
ingredient (API) suppliers before the end of 2012 and for a third API supplier
in the first quarter of 2013. This brings to four, the total number of API
suppliers for Vascepa and is part of Amarin's strategy to mitigate risk
through multiple suppliers.

Amarin's sNDA has been prepared for the patient population studied in the
ANCHOR Phase 3 trial. Consistent with prior guidance, Amarin plans to file
this sNDA once its cardiovascular outcomes study, REDUCE-IT, is substantially
underway. As previously discussed in Amarin's second quarter 2012 results
conference call, based on continued REDUCE-IT progress Amarin anticipates
submitting this sNDA to the FDA no later than the end of February 2013
resulting in an anticipated PDUFA action date for the ANCHOR sNDA before the
end of 2013.

Vascepa exclusivity update

Amarin continues to make significant progress in its effort to expand the
patent protection for Vascepa in the United States and now has 8 patents
either issued or allowed and over 30 additional patent applications being
prosecuted. Amarin is also pursuing patent applications related to Vascepa in
multiple jurisdictions outside the United States, including the application
for Amarin's MARINE method of use patent in Europe for which Amarin previously
announced receipt of an Intention to Grant letter. Amarin's goal is to protect
the commercial potential of Vascepa to beyond 2030 through patent protection,
regulatory exclusivity and trade secrets and by taking advantage of
manufacturing barriers to entry.

Amarin expects the FDA to make a determination to award Vascepa either
three-years of marketing exclusivity or five-years of marketing exclusivity. A
marketing exclusivity determination may help to clarify the ultimate path for
Vascepa commercialization among Amarin's three previously-disclosed potential
paths: an acquisition of Amarin, a strategic collaboration, or
self-commercialization, the latter of which could include third-party support.

Commercialization update

As Amarin continues to pursue in parallel three potential paths for the
marketing and sale of Vascepa and, as previously guided, Amarin is beginning
to build inventory of Vascepa capsules in preparation for commercial launch of
Vascepa early in the first quarter of 2013. Amarin is also taking other steps
to prepare for launch, including increased managed care outreach, increased
activity at trade shows and other venues and selectively adding management
personnel.

Investor presentations

Amarin expects to participate in the following upcoming investor conferences:
Lazard 9^th Annual Healthcare Conference in New York City, November 13, 2012,
3:00 pm ET (a live audio webcast of the presentation will be available at:
http://wsw.com/webcast/lz13/amrn/); 31^st Annual JP Morgan Healthcare
Conference in San Francisco, January 7-10, 2013; and CITI's 2013 Global
Healthcare Conference in New York City, February 25-27, 2013.

Financial update

Amarin reported cash and cash equivalents of $215.1 million at September 30,
2012, the end of its third quarter, representing a decrease of approximately
$35.2 million from the company's cash balance at the end of its second
quarter. Included in these cash outflows were payments to clinical research
organizations in connection with Amarin's Vascepa clinical trial activities as
well as various costs associated with commercial readiness and expanded patent
prosecution. Amarin's cash outflows during this period were partially offset
by $2.8 million in proceeds from the exercise of warrants and stock options.

Under U.S. Generally Accepted Accounting Principles (GAAP), Amarin reported a
net loss for the three months ended September 30, 2012 of $26.4 million, or
basic and diluted loss per share of $0.18, including $4.6 million in
share-based compensation expense, $1.2 million in warrant compensation income,
and a $16.5 million gain on the change in the fair value of non-cash financial
derivative. For the same period in 2011, GAAP net income was $96.3 million, or
basic and diluted income per share of $0.72 and $0.62, respectively, including
$2.7 million in share-based compensation expense, $3.4 million in warrant
compensation income, and a $106.6 million gain on the change in the fair value
of non-cash financial derivative.

Excluding non-cash losses for share-based, warrant-based compensation and
change in value of derivative, non-GAAP adjusted net loss was $39.4 million
for the third quarter of 2012 (basic and diluted loss per share of $0.26)
compared to a non-GAAP adjusted net loss of $11.0 million (basic and diluted
loss per share of $0.08) for the same period in the prior year.

Conference call and webcast information

Amarin will host a conference call at 4:30 p.m. EST today, November 8, 2012.
To participate in the call, please dial (877) 407-8033 within the United
States or (201) 689-8033 from outside the United States. A replay of the call
will be made available for a period of two weeks following the conference
call. To hear a replay of the call, dial (877) 660-6853 (inside the U.S.) or
(201) 612-7415 (outside the U.S.).  A replay of the call will also be
available through Amarin's website shortly after the call. For both dial-in
numbers please use account number 286 and conference ID 402385.  The
conference call can also be heard live through the investor relations section
of Amarin's website at www.amarincorp.com.

Use of non-GAAP adjusted financial information

Included in this press release and the conference call referenced above are
non-GAAP adjusted financial information as defined by SEC Regulation G. The
GAAP financial measure most directly comparable to each non-GAAP adjusted
financial measure used or discussed, and a reconciliation of the differences
between each non-GAAP adjusted financial measure and the comparable GAAP
financial measure, are included in this press release after the condensed
consolidated financial statements. 

Non-GAAP adjusted net loss was derived by taking GAAP net loss and adjusting
it with non-cash gains or losses for share-based, warrant-based compensation,
and change in value of derivative. Amarin's management believes that these
non-GAAP adjusted measures provide investors with a better understanding of
the company's historical results from its core business operations by
excluding them.

While management believes that this non-GAAP adjusted financial measure
provides useful supplemental information to investors regarding the underlying
performance of the company's business operations, investors are reminded to
consider this non-GAAP measure in addition to, and not as a substitute for,
financial performance measures prepared in accordance with GAAP. Non-GAAP
measures have limitations in that they do not reflect all of the amounts
associated with the company's results of operations as determined in
accordance with GAAP. In addition, it should be noted that these non-GAAP
financial measures may be different from non-GAAP measures used by other
companies, and management may utilize other measures to illustrate performance
in the future.

About Amarin

Amarin Corporation plc is a biopharmaceutical company focused on the
commercialization and development of therapeutics to improve cardiovascular
health. Amarin's product development program leverages its extensive
experience in lipid science and the potential therapeutic benefits of
polyunsaturated fatty acids. Vascepa^TM (icosapent ethyl), Amarin's first FDA
approved product, is a patented, ultra pure omega-3 fatty acid product
comprising not less than 96% EPA. For more information about Vascepa visit
www.vascepa.com. For more information about Amarin visit www.amarincorp.com.

The Amarin Corporation plc logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=13817

Forward-looking statements

This press release contains forward-looking statements, including statements
about the  timing of a commercial launch of Vascepa, preparations for
commercial launch, including among other things plans to purchase commercial
supply, the potential additional indications for which FDA marketing approval
of Vascepa may be sought and the timing of planned regulatory filings and
decisions, the potential for an acquisition of Amarin or a strategic
collaboration with a third party for the commercialization of Vascepa, the
timing and outcome of FDA's review determination of whether Vascepa should be
granted new chemical entity or new product marketing exclusivity, the status
of patent applications currently under review by the United States Patent and
Trademark Office, the coverage and expected expiration dates of those patent
applications and issued patents and the ability of Amarin to protect the
commercial potential of Vascepa. In particular there can be no assurance that
Vascepa will be awarded five-year new chemical entity or three-year new
product marketing exclusivity and the FDA may take longer than expected to
reach any such determination. These forward-looking statements are not
promises or guarantees and involve substantial risks and uncertainties. Among
the factors that could cause actual results to differ materially from those
described or projected herein include the following: uncertainties associated
generally with the commercial success of new pharmaceutical products, such as
Vascepa; Amarin's ability to negotiate and execute a successful acquisition of
Amarin or a strategic collaboration with a third party for the
commercialization of Vascepa; Amarin's lack of experience with commercializing
pharmaceutical products; risks associated with preparations associated with a
commercial launch; the risk that FDA may not grant new chemical entity or new
product marketing exclusivity to Vascepa; the risk that FDA may not reach a
determination with respect to these matters on the timetable that we expect;
the risk that patent applications may not result in issued patents, and that
issued patents may not prevent competitors from competing with Vascepa; the
risk that competitors may challenge the validity, enforceability or both the
validity and enforceability of our patents or seek to design products around
our issued patent claims and gain marketing approval for generic versions of
Vascepa or branded competitive products based on new clinical studies; and the
risk that trade secrets may not be maintained and that circumstances that
create manufacturing barriers to entry may not last. A further list and
description of these risks, uncertainties and other risks associated with an
investment in Amarin can be found in the "Risk Factors" section of Amarin's
filings with the U.S. Securities and Exchange Commission, including its most
recent Quarterly Report on Form 10-Q. Existing and prospective investors are
cautioned not to place undue reliance on these forward-looking statements,
which speak only as of the date hereof. Amarin undertakes no obligation to
update or revise the information contained in this press release, whether as a
result of new information, future events or circumstances or otherwise except
as required by law.

Amarin's product candidates are in various stages of development and are not
available for sale or use outside of approved clinical trials. This press
release is intended for communication with investors. Nothing in this press
release should be construed as marketing the use of such product candidates.

CONSOLIDATED BALANCE SHEET DATA
(U.S. GAAP)
                                           
                                          September 30, 2012 December 31, 2011
                                          (in thousands)
ASSETS
Current Assets                                                
Cash and cash equivalents                  $ 215,110          $ 116,602
Inventory                                 8,989              --
Deferred tax asset                        533                533
Other current assets                      4,110              1,837
Total Current Assets                       $ 228,742          $ 118,972
                                                              
Property, plant and equipment, net        796                432
Deferred tax asset                        9,788              4,734
Other long term assets                    15,672             2,241
                                                              
Total Assets                               $ 254,998         $ 126,379
                                                              
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
Current Liabilities:                                          
Accounts payable                           $ 13,696           $ 4,419
Accrued expenses and other liabilities    18,816             4,033
Total current liabilities                  $ 32,512           $ 8,452
                                                              
Long-Term Liabilities                                         
Warrant derivative liability              90,963             123,125
Long term debt                            130,783            ----
Other long-term liabilities               702                764
Total liabilities                          $ 254,960          $ 132,341
                                                              
Stockholders' Equity (Deficit)                                
Common Stock                              124,244            113,321
Additional paid-in capital                613,087            449,393
Treasury Stock                            (217)              (217)
Accumulated deficit                       (737,076)          (568,459)
Total stockholders' equity (deficit)       $ 38               $ (5,962)
                                                              
Total Liabilities and Stockholders'        $ 254,998          $ 126,379
Equity (Deficit)

 
CONSOLIDATED STATEMENTS OF OPERATIONS DATA
(U.S. GAAP)
Unaudited
                                                                   
                       Three Months Ended Sept 30  Nine Months Ended Sept 30
                       (in thousands, except share (in thousands, except share
                       and                         and
                       per share amounts)          per share amounts)
                       2012            2011        2012           2011
                                                                   
Revenues                $ -----         $ -----    $ -----         $ ----- 
OPERATING EXPENSES:                                                
Research and           20,913          6,013       39,735         15,651
development(1)
Marketing, general and 13,397          3,433       41,059         16,185
administrative(1)
Total operating        34,310          9,446       80,794         31,836
expenses
Operating loss         (34,310)        (9,446)     (80,794)       (31,836)
Gain (Loss) on change
in fair value of       16,454          106,614     (68,686)       (53,403)
derivative
liability(2)
Interest income        (4,570)         3           (12,838)       97
(expense), net
Other income           (427)           (59)        (411)          30
(expense), net
Income (Loss) from
operations before      (22,853)        97,112      (162,729)      (85,112)
taxes
Provision for income   (3,573)         (767)       (5,888)        (2,352)
taxes
Net and comprehensive   $ (26,426)      $ 96,345    $ (168,617)    $ (87,464)
income (loss)
(Loss) income per                                                  
share: 
Basic                   $ (0.18)        $ 0.72      $ (1.19)       $ (0.68)
Diluted                 $ (0.18)        $ 0.62      $ (1.19)       $ (0.68)
Weighted average                                                   
shares:
Basic                  149,200         133,238     141,947        128,377
Diluted                149,200         155,975     141,947        128,377
(1)  A substantial portion of the Amarin's marketing, general and
administrative costs represents non-cash warrant based compensation to former
officers. Excluding non-cash stock and warrant based compensation, research
and development expenses were $19,943 and $5,607 for the three months ending
September 30, 2012 and 2011, respectively, and marketing, general and
administrative expenses were $10,926 and $4,529, respectively, for the same
periods. 
(2)  Non-cash charges result from changes in the fair value of the warrant
derivative liability. This liability is revalued at each reporting period and,
upon exercise of warrants, is reclassified at fair value from liability to
stockholders' equity. These warrants are valued using the Black-Scholes option
pricing model, they are classified for accounting purposes as financial
derivatives because, under certain circumstances, the exercise price of the
warrants could increase. 

The following is a reconciliation of the non-GAAP financial measures used by
Amarin to describe its financial results determined in accordance with United
States generally accepted accounting principles (GAAP). An explanation of
these measures is also included under the heading "Use of Non-GAAP Adjusted
Financial Information" above.

RECONCILIATION OF NON-GAAP LIABILITIES
Unaudited
                                                           
                                       September 30, 2012 December 31, 2011
                                       (in thousands)
Current Liabilities:                                       
Accounts payable                        $ 13,696           $ 4,419
Accrued expenses and other liabilities 18,816             4,033
Total current liabilities               $ 32,512           $ 8,452
                                                           
Long-Term Liabilities                                      
Warrant derivative liability           90,963             123,125
Long term debt                         130,783            ----
Other long-term liabilities            702                764
Total liabilities – GAAP                $ 254,960          $ 132,341
Warrant derivative liability           (90,963)           (123,125)
Total liabilities – non GAAP            $ 163,997          $ 9,216

                                                    
                                                    
                       Three Months Ended Sept 30  Nine Months Ended Sept 30
                       (in thousands, except share (in thousands, except share
                       and per share amounts)      and
                                                   per share amounts)
                       2012            2011        2012           2011
                                                                   
Net income (loss) for   $ (26,426)      $ 96,345    $ (168,617)    $ (87,464)
EPS^1 – GAAP
Share based            4,635           2,662       13,344         6,022
compensation expense
Warrant compensation   (1,194)         (3,352)     3,037          1,004
(income) expense
(Gain) loss on change
in fair value of       (16,454)        (106,614)   68,686         53,403
derivative
Adjusted net income
(loss) for EPS^1 – non (39,439)        (10,959)    (83,550)       (27,035)
GAAP
^1Basic and diluted                                                
Loss per share:                                                    
Basic and diluted –     $ (0.26)        $ (0.08)    $ (0.59)       $ (0.21)
non GAAP
                                                                   
Weighted average                                                   
shares:
Basic and diluted      149,200         133,238     141,947        128,377

CONTACT: Investor contact information:
         Stephen D. Schultz
         Senior Director, Investor Relations and Corporate Communications
         Amarin Corporation
         In U.S.: +1 (860) 572-4979 x292
         investor.relations@amarincorp.com
        
         Lee M. Stern
         The Trout Group
         In U.S.: +1 (646) 378-2922
         lstern@troutgroup.com
        
         Media contact information:
         David Schull or Martina Schwarzkopf, Ph.D.
         Russo Partners
         In U.S.: +1 (212) 845-4271 or +1 (212) 845-4292 (office)
         +1 (347) 591-8785 (mobile)
         david.schull@russopartnersllc.com
         martina.schwarzkopf@russopartnersllc.com

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