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Amarin Reports Fourth Quarter and Year-End 2012 Financial Results and Provides Update on Operations



Amarin Reports Fourth Quarter and Year-End 2012 Financial Results and Provides
Update on Operations

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

BEDMINSTER, N.J. and DUBLIN, Ireland, Feb. 28, 2013 (GLOBE NEWSWIRE) -- Amarin
Corporation plc (Nasdaq:AMRN), a late-stage biopharmaceutical company focused
on the commercialization and development of therapeutics to improve
cardiovascular health, today announced financial results for the quarter and
year ended December 31, 2012 and provided an update on company operations.

Key Amarin accomplishments since the quarter ended September 30, 2012 include:

  * Launched Vascepa^® (icosapent ethyl) capsules in the United States on
    January 28, 2013 for the MARINE indication (use as an adjunct to diet to
    lower triglyceride levels in adult patients with severe (≥500 mg/dL)
    hypertriglyceridemia)
  * Hired and trained U.S. sales team, including 275 sales representatives
    with extensive cardiovascular selling experience and relationships with
    healthcare professionals targeted for Vascepa along with key sales and
    marketing hires for Amarin's commercial team
  * Stocked Vascepa at wholesalers and leading pharmacies
  * Achieved >160 million lives covered by payors
  * Submitted sNDA (supplemental New Drug Application) seeking approval in the
    United States of Vascepa for use in a second indication (ANCHOR)
  * Submitted two sNDAs for additional active pharmaceutical ingredient (API)
    suppliers: Chemport and BASF
  * Strengthened supply chain with an exclusive agreement entered into by a
    consortium of companies, led by Slanmhor Pharmaceuticals, Inc., to be
    Amarin's fourth Vascepa API supplier
  * Increased patents issued or allowed to 18 in the United States, a majority
    of which have patent terms extending into 2030, with more than 30
    additional U.S. patent applications being prosecuted
  * Completed dosing of a fixed-dose combination study with Vascepa and a
    leading statin
  * Publication of MARINE and ANCHOR Phase 3 trial results in The American
    Journal of Cardiovascular Drugs
  * Strengthened balance sheet through successful completion of a $100M
    non-dilutive, hybrid debt financing resulting in a year-end cash balance
    of $260.2 million

"In 2012, Amarin received FDA approval of Vascepa capsules for the use in its
initial indication, the MARINE indication," said Joseph Zakrzewski, Chairman
and Chief Executive Officer of Amarin. "In early 2013, we launched Vascepa for
the MARINE indication and submitted a sNDA with the FDA seeking approval for
the ANCHOR indication, which would enable promotion of Vascepa to a
significantly larger patient population. These significant achievements have
been supported by considerable progress on multiple fronts, including the
strengthening of our supply chain, expanding our patent protection for Vascepa
and building a seasoned and capable commercial team. We look forward to
continued progress in 2013."

Operational update

Commercialization update

Amarin believes that Vascepa is well positioned to compete in the triglyceride
lowering market. This is a large market which, based on market research,
Amarin believes is currently underpenetrated due to limitations of existing
therapies. Amarin's market research further suggests that clinicians value the
data supporting Vascepa in the MARINE indication: in patients with very high
(≥500 mg/dL) triglyceride levels, Vascepa has been shown to lower
triglycerides without increasing bad cholesterol (low-density lipoprotein
cholesterol, or LDL-C) and with a tolerability and safety profile similar to
placebo. Amarin formally launched Vascepa in the United States on January 28,
2013. In support of that commercial launch, Amarin has:

  * More than 160 million lives covered by managed care plans and insurance
    payors and has begun migrating these plans from Tier-3 to Tier-2 coverage
  * Implemented robust early physician awareness and speaker programs
  * Implemented a co-pay reduction program that offers Vascepa to patients for
    a co-pay cost equivalent to competitors
  * Realized strong initial wholesale stocking of Vascepa to help ensure that
    prescriptions can be filled promptly
  * Developed and launched a robust digital and print media campaign to
    support direct sales force efforts to educate various customer segments,
    including clinicians, about Vascepa
  * Received early, but encouraging, feedback from physicians regarding
    Vascepa and results

Vascepa regulatory progress

On February 26, 2013, Amarin announced that it submitted a sNDA to the FDA
requesting approval to market and sell Vascepa to the patient population
studied in the ANCHOR Phase 3 trial, adult patients with high triglyceride
levels (>200 mg/dL and <500 mg/dL) who are also on statin therapy for elevated
LDL-C, which we refer to as mixed dyslipidemia. Assuming that this sNDA is
accepted, Amarin expects to be notified within 74-days (inclusive of the
standard 60-day review and the standard 14-day communication periods) and
anticipates the assignment of a PDUFA action date before the end of 2013 for
the ANCHOR indication, consistent with the standard 10-month review period.
The safety results from the ANCHOR trial are included in the current label for
Vascepa. All of the primary and secondary efficacy endpoints of the ANCHOR
trial were achieved at the 4 gram dose.

In the fourth quarter of 2012, Amarin submitted two sNDAs, one each for two
additional active pharmaceutical ingredient (API) suppliers for Vascepa, BASF
and Chemport. Amarin expects these sNDA filings to be subject to the standard
review period for such submissions with potential approvals in the second half
of 2013.  Qualification of these suppliers is part of Amarin's strategy to
expand our supply chain to provide greater capacity to meet anticipated
demand, enable supply diversification and flexibility and introduce cost
competition among high quality suppliers. 

Vascepa exclusivity update

Amarin continues to make significant progress in its effort to expand patent
protection for Vascepa and now has 18 patents issued or allowed with over 30
additional patent applications being prosecuted in the United States. This
patent portfolio includes claims covering key elements of Vascepa's
pharmaceutical composition and methods of use for the MARINE indication,
ANCHOR indication and other potential uses of Vascepa. Amarin is also pursuing
patent applications related to Vascepa in multiple jurisdictions outside the
United States. Amarin's goal is to protect the commercial potential of Vascepa
beyond 2030. Patent protection for Vascepa is augmented by protection provided
by trade secrets, taking advantage of manufacturing barriers to entry and
regulatory exclusivity. 

REDUCE-IT and other Vascepa-related clinical development

In 2012, Amarin's REDUCE-IT cardiovascular outcomes study efforts were
primarily focused on clinical site activation and patient enrollment. The
REDUCE-IT study seeks to evaluate the rate of cardiovascular events in at-risk
patients treated with statins plus Vascepa compared to patients treated with
statins plus placebo. The study is currently estimated to be completed in
approximately six years and designed to enroll approximately 8,000
patients. Amarin anticipates 2013 to be an important year for REDUCE-IT as it
continues to support the clinical sites and their patients that are currently
active in the study while continuing progress in enrolling additional patients
needed to complete trial enrollment.

Financial update

Amarin reported cash and cash equivalents of $260.2 million at December 31,
2012.  

During the three months ended December 31, 2012, cash outflows from operating
activities were approximately $55.4 million, including $12.1 million paid to
stockholders of Laxdale as milestone payments pursuant to U.S. regulatory
approval of Vascepa in the prior quarter and $16 million paid to suppliers in
conjunction with the build-up of Vascepa inventory levels in advance of its
commercial launch in early 2013. Excluding these milestone payments and
supply-related payments, cash outflows from operating activities during the
three months ended December 31, 2012 totaled approximately $27.3 million,
primarily comprised of payments for research and development activities,
including $6.1 million paid to a clinical research organization in connection
with the REDUCE-IT cardiovascular outcomes trial, and $12.1 million in
marketing sales and general and administrative activities related to our
Vascepa commercial launch preparations.

Cash used for operating activities during the twelve months ended December 31,
2012 was approximately $122.3 million, compared to approximately $39.4 million
in 2011, including $31.5 paid in 2012 for Vascepa supply and $23.3
million paid to a clinical research organization in connection with the
REDUCE-IT cardiovascular outcomes trial.

Under U.S. Generally Accepted Accounting Principles (GAAP), Amarin reported a
net loss of $10.6 million in the fourth quarter of 2012, or basic and diluted
loss per share of $0.07. This net loss included $4.7 million in non-cash
share-based compensation expense, $2.8 million in non-cash warrant
compensation income, and a $33.3 million gain on the change in the fair value
of derivatives. In the fourth quarter of 2011, GAAP net income was $18.3
million, or basic income per share of $0.14, diluted income per share of
$0.12, and included $3.3 million in non-cash share-based compensation expense,
$1.1 million in non-cash warrant compensation income, and a $30.7 million gain
on the change in the fair value of a derivative.

Excluding non-cash gains or losses for share-based compensation, warrant
compensation and change in value of derivatives, non-GAAP adjusted net loss
was $42.0 million for the fourth quarter of 2012, or non-GAAP adjusted basic
and diluted loss per share of $0.28, compared to non-GAAP adjusted net loss of
$10.2 million, or non-GAAP adjusted basic and diluted loss per share of $0.08
for the same period in 2011.

As of December 31, 2012, Amarin had approximately 150.3 million ADSs
outstanding as well as approximately 9.9 million, 10.9 million, and 0.5
million equivalent shares underlying warrants, stock options, and restricted
stock units, respectively, at average exercise prices of $1.44, $7.29 and
$8.86, respectively. In addition, our $150 million exchangeable senior notes
issued in January 2012 are exchangeable prior to October 15, 2031 into an
aggregate of 17.0 million ADSs (based on an initial exchange price of
approximately $8.81 per ADS), subject to certain specified conditions. The
notes accrue interest at an annual rate of 3.5%, payable semiannually in
arrears on January 15 and July 15, beginning July 15, 2012. The notes will
mature on January 15, 2032, unless earlier repurchased or redeemed by the
company or exchanged by the holders.

Amarin's 2013 operational priorities

Operational priorities in the upcoming year include the following:

  * Increasing revenues from Vascepa
  * Approval of the ANCHOR indication sNDA
  * Additional patent awards from the USPTO
  * FDA approval of additional API suppliers
  * Managed care migration from Tier-3 to Tier-2 coverage
  * Continued publication of data from Amarin's clinical trials
  * FDA exclusivity determination

Conference call and webcast information

Amarin will host a conference call at 4:30 p.m. EST (8:30 p.m. UTC/GMT)
today, February 28, 2013. 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 conference ID 408629.  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 compensation, warrant
compensation, and change in value of derivative. The company'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. While management believes that these non-GAAP adjusted financial
measures provide useful supplemental information to investors regarding the
underlying performance of the company's business operations, investors are
reminded to consider these non-GAAP measures 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 Vascepa® (icosapent ethyl) capsules

Vascepa® (icosapent ethyl) capsules, known in scientific literature as AMR101,
is a patented, pure-EPA omega-3 prescription product in a 1 gram capsule.

Indications and Usage

  * Vascepa (icosapent ethyl) is indicated as an adjunct to diet to reduce
    triglyceride (TG) levels in adult patients with severe (≥500 mg/dL)
    hypertriglyceridemia.
  * The effect of Vascepa on the risk for pancreatitis and cardiovascular
    mortality and morbidity in patients with severe hypertriglyceridemia has
    not been determined.

Important Safety Information for Vascepa

  * Vascepa is contraindicated in patients with known hypersensitivity (e.g.,
    anaphylactic reaction) to Vascepa or any of its components and should be
    used with caution in patients with known hypersensitivity to fish and/or
    shellfish.
  * The most common reported adverse reaction (incidence >2% and greater than
    placebo) was arthralgia.

FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.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 FDA decisions regarding Vascepa and sNDA acceptances and
review; the efficacy, safety and therapeutic benefits of Vascepa; Amarin plans
to seek regulatory approval for its product candidates and API suppliers;
commercialization and revenue from Vascepa and preparation for
commercialization of its product candidates; Amarin's ability to obtain patent
protection and regulatory exclusivity for its product candidates, maintain
trade secrets, and take advantage of manufacturing barriers to entry;
enrollment of patients in its REDUCE-IT cardiovascular outcomes study;
obtainment of Tier 2 treatment from managed care payors for Vascepa; continued
publication of study data; and continued assessment of collaboration prospects
for commercialization of Vascepa. 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 research and development, clinical trials and related
regulatory approvals; the risk that SPAs are not a guarantee that FDA will
approve a product candidate upon submission; the risk that FDA may not accept
review of the submitted ANCHOR sNDA due to the FDA's opinion on the lack of
substantial enrollment in the REDUCE-IT trial or otherwise, the risk that the
FDA may not complete its review of the Vascepa API sNDAs or the ANCHOR sNDA by
the PDUFA action date or grant new chemical entity regulatory exclusivity to
Vascepa; the risk that historical REDUCE-IT clinical trial enrollment and
randomization rates may not be predictive of future results and related cost
may increase beyond expectations; the risk that patent applications may not
result in issued patents, trade secrets may not be maintained and that
circumstances that create manufacturing barriers to entry may not last; the
risk that Amarin may not enter into a collaboration agreement for the
commercialization of Vascepa in the ANCHOR indication under favorable terms or
at all; and the risk that publications of scientific data may not accept
proposals to publish Vascepa data. A further list and description of these
risks, uncertainties and other risks associated with an investment in Amarin
can be found in Amarin's filings with the U.S. Securities and Exchange
Commission, including its most recent Annual Report on Form 10-K. 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.

Vascepa has been approved for use by the FDA as an adjunct to diet to lower
triglyceride levels in adult patients with severe (≥500 mg/dL)
hypertriglyceridemia. Vascepa is under various stages of development for
potential use in other indications that have not been approved by the
FDA. Nothing in this press release should be construed as marketing the use of
Vascepa in any indication that has not been approved by the FDA.

 
CONSOLIDATED BALANCE SHEET DATA
(U.S. GAAP)
Unaudited
                                            December 31,
                                            2012       2011
                                            (in thousands)
ASSETS                                                               
Current Assets                                          
 Cash and cash equivalents                   $ 260,242  $ 116,602
 Deferred tax asset                         937        533
 Inventory                                  21,262     --
 Other current assets                       3,253      1,837
 Total Current Assets                        $ 285,694  $ 118,972
                                                        
 Property, plant and equipment, net         811        432
 Deferred tax asset                         8,044      4,734
 Other non-current assets                   4,951      2,241
 Intangible asset, net                      11,355     --
                                                        
Total Assets                                 $ 310,855  $ 126,379
                                                        
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)                       
Current Liabilities:                                    
 Accounts payable                            $ 17,458   $ 4,419
 Accrued interest payable                   2,520      --
 Accrued expenses and other liabilities     5,224      4,033
 Total current liabilities                   $ 25,202   $ 8,452
                                                        
Long Term Liabilities                                   
 Warrant derivative liability               54,854     123,125
 Long term debt redemption feature          14,577     --
Exchangeable senior notes                   134,250    --
 Long term debt                             85,153     --
 Other long term liabilities                816        764
 Total liabilities                           $ 314,852  $ 132,341
                                                        
Stockholders' Deficit                                   
 Common stock                               124,597    113,321
 Additional paid-in capital                 619,266    449,393
 Treasury stock                             (217)      (217)
 Accumulated deficit                        (747,643)  (568,459)
 Total stockholders' deficit                 $ (3,997)  $ (5,962)
                                                        
Total Liabilities and Stockholders' Deficit  $ 310,855  $ 126,379

 
CONSOLIDATED STATEMENTS OF OPERATIONS DATA
(U.S. GAAP)
Unaudited
                                                                   
                       Three Months Ended Dec 31   Twelve Months Ended Dec 31
                       (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          19,221         5,951        58,956         21,602
development(1)
 Marketing, general    16,735         6,374        57,794         22,559
and administrative(1)
 Total operating       35,956         12,325       116,750        44,161
expenses
Operating loss         (35,956)       (12,325)     (116,750)      (44,161)
Gain (loss) on change
in fair value of       33,342         30,734       (35,344)       (22,669)
derivative
liabilities(2)
 Interest income       (4,709)        133          (17,547)       230
(expense), net
 Other income          (17)           (40)         (427)          (10)
(expense), net
Income (loss) from
operations before      (7,340)        18,502       (170,068)      (66,610)
taxes
Provision for income   (3,229)        (164)        (9,116)        (2,516)
taxes
Net and comprehensive   $ (10,569)     $ 18,338     $ (179,184)    $ (69,126)
income (loss)
Income (loss) per                                                  
share: 
Basic                   $ (0.07)       $ 0.14       $ (1.24)       $ (0.53)
Diluted                $ (0.07)       $ 0.12        $ (1.24)       $ (0.53)
                                                                   
Weighted average                                                   
shares oustanding:
Basic                  150,184        135,797      144,017        130,247
Diluted                150,184        156,630      144,017        130,247
                                                                   
                                                                   
(1)  Amarin's costs include non-cash stock based compensation as well as
warrant based compensation to former officers. Excluding non-cash stock and
warrant based compensation, research and development expenses were $55,256 and
$20,138 for 2012 and 2011, respectively, and marketing, general and
administrative expenses were $43,172 and $14,825, 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
                                                    
                                        December 31,
                                        2012       2011
                                        (in thousands)
Current Liabilities:                                
 Accounts payable                        $ 17,458   $ 4,419
 Accrued interest payable               2,520      --
 Accrued expenses and other liabilities 5,224      4,033
 Total current liabilities               $ 25,202   $ 8,452
                                                    
Long-Term Liabilities                               
 Warrant derivative liability           54,854     123,125
 Long term debt redemption feature      14,577     --
 Exchangeable senior notes              134,250    --
 Long-term debt                         85,153     --
 Other long-term liabilities            816        764
 Total liabilities – GAAP                $ 314,852  $ 132,341
 Warrant derivative liability           (54,854)   (123,125)
 Total liabilities – non GAAP            $ 259,998  $ 9,216

 
RECONCILIATION OF NON-GAAP NET INCOME / (LOSS)
Unaudited 
                                                                   
                        Three Months Ended Dec 31, Twelve Months Ended Dec 31,
                        2012          2011         2012           2011
                        (In thousands, except share and per share amounts)
Net income/(loss) for    $ (10,569)    $ 18,338     $ (179,184)    $ (69,126)
EPS^1 – GAAP 
 Share based            (4,731)       (3,272)      (18,075)       (9,294)
compensation expense
 Warrant compensation   2,790         1,100        (247)          96
income (expense)
 Gain/(loss) on change
in fair value of        33,342        30,734       (35,344)       (22,669)
derivatives
Adjusted net loss for    $ (41,970)    $ (10,224)   $ (125,518)    $ (37,259)
EPS^1 – non GAAP
^1Basic and diluted                                                
Loss per share:                                                    
 Basic and diluted –     $ (0.28)      $ (0.08)     $ (0.87)       $ (0.29)
non GAAP 
                                                                   
Weighted average shares                                            
oustanding:
 Basic and diluted      150,184       135,797      144,017        130,247

CONTACT: Stephen Schultz or Joseph Bruno
         Senior Director, Investor Relations
         and Corporate Communications
         Amarin Corporation plc
         In U.S.: +1 (908) 719-1315
         investor.relations@amarincorp.com

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