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`https://www.sec.gov/Archives/edgar/data/897448/000110465905007516/a05-3807_1ex99d1.htm
`EX-99.1 2 a05-3807_1ex99d1.htm EX-99.1
`
`Exhibit 99.1
`
`Contact:
`Rick Stewart
`Chief Executive Officer
`Amarin Corporation plc
`Phone +44 (0) 207 907 2442
`investor.relations@amarincorp.com
`
`Alan Cooke
`Chief Financial Officer
`Amarin Corporation plc
`Phone +44 (0) 207 907 2442
`
`
`
`AMARIN REPORTS FOURTH QUARTER AND FULL YEAR 2004 RESULTS
`
`LONDON, United Kingdom, February 17, 2005 – Amarin Corporation plc (NASDAQSC: AMRN) today reported financial results
`for the quarter and full year ended December 31, 2004.
`
`For the quarter ended December 31, 2004, Amarin reported a net loss, including discontinued activities, of $4.8 million or 13 cents per
`American Depositary Share (ADS), compared with a net loss of $2.8 million or 15 cents per ADS in the quarter ended December 31,
`2003.
`
`For the year ended December 31, 2004, Amarin reported net income, including discontinued activities, of $4.7 million or 21 cents per
`ADS, compared with a net loss of $19.3 million or $1.13 per ADS in the year ended December 31, 2003.
`
`2004 – KEY HIGHLIGHTS
`•
`
`Sale of U.S. Operations – on February 25, Amarin’s U.S. sales and marketing operations were sold to Valeant Pharmaceutical
`International, Inc (“Valeant”) for $38 million in cash and $8 million in contingent milestones;
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
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`Settlement of debt obligations – on February 25, Amarin settled its debt obligations with Elan Corporation, plc (“Elan”) from the
`proceeds received from the sale of its U.S. operations to Valeant and by issuing a $5 million 5-year loan note;
`
`Valeant dispute settlement – on September 28, Amarin signed an agreement with Valeant settling an outstanding dispute between
`the companies whereby $6 million of the $8 million in contingent milestones due to Amarin from Valeant were waived. The
`remaining $2 million of milestones became non-contingent and was paid by Valeant to Amarin on December 1;
`
`Significant investment by Amarin chairman – on October 6, Amarin’s non-executive chairman, Mr. Thomas Lynch, acquired
`Elan’s entire debt and equity interests held in Amarin, including 4,653,819 ADSs and the previously noted $5 million 5-year loan
`note;
`
`Equity financing – on October 7, a private placement of 13,474,945 ordinary shares raising gross proceeds for Amarin of $12.75
`million was completed with a group of new and existing investors and management;
`
`Total debt reduced to $2 million and maturity extended to 2009 – on October 7, Mr. Lynch agreed to convert $3 million of the $5
`million loan notes into 2,717,391 ordinary shares with an option to convert the remaining $2 million at the offering price of any
`future equity financing. Amarin’s total debt was thus reduced to, and is currently at, $2 million with a maturity in 2009, if not
`previously converted;
`
`Laxdale acquisition – on October 8, Amarin completed the acquisition of Laxdale Limited (“Laxdale”), the Company’s
`neuroscience research and development partner based in Stirling, Scotland. The acquisition provides Amarin with a promising
`late stage neuroscience pipeline for central nervous system disorders.
`
`Rick Stewart, chief executive officer of Amarin, commented “2004 has been a year of significant transformation. The company is now
`a highly focused R&D based neuroscience company. This was achieved through the execution of a series of significant transactions
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`which included the sale of Amarin’s U.S. sales and marketing operations, the settlement of our outstanding debt obligations to Elan and
`the acquisition of our R&D development partner, Laxdale. In addition, our non-executive chairman, Thomas Lynch, became Amarin’s
`largest shareholder, with an equity stake now of approximately 20%, through acquiring all Elan’s remaining debt and equity interests in
`Amarin. Finally, in October, we raised $12.75 million in a private placement and at the beginning of 2005, added two prominent
`business leaders, Simon Kukes and Michael Walsh, to our board.”
`
`Mr. Stewart continued “Amarin’s continuing focus is clear. We are progressing the clinical development of Miraxion, our exciting lead
`product for Huntington’s disease and treatment-unresponsive depression. We look forward to commencing two large phase III trials in
`Huntington’s disease by mid-year and partnering our phase II treatment-unresponsive depression programme later in 2005.”
`
`ACQUISITION OF LAXDALE
`
`The acquisition of Laxdale, Amarin’s research and development partner, was completed in October 2004 and represents an important
`step towards achieving Amarin’s goal of becoming a leader in the development and commercialization of novel drugs for the treatment
`of central nervous system (“CNS”) disorders. The acquisition broadens Amarin’s development pipeline to include North American,
`E.U. and Japanese rights to Miraxion for all CNS disorders, including Huntington’s disease and treatment-unresponsive depression. In
`addition, it provides Amarin with an extensive portfolio of intellectual property in the area of CNS.
`
`Program
`
`Lipophilic Platform
`
`Indication
`
`Status
`
`Partners
`
`Miraxion
`
`Huntington’s disease
`
`Phase III
`
`Scil Biomedical GmbH (Germany, Austria, France,
`Benelux)
`
`Juste S.A.Q.F. (Spain, Portugal)
`
`Miraxion
`
`Treatment-unresponsive
`depression
`
`Combinatorial Lipid Platform
`
`Phase II
`
`Link Pharmaceuticals Ltd (UK, Ireland)
`Japan – partner not disclosed
`
`Various
`
`In-licensed
`
`LAX-201
`
`LAX-202
`
`CNS disorders
`
`Pre-clinical
`
`—
`
`Major Depression in Women
`
`Multiple Sclerosis Fatigue
`
`Phase II
`
`Phase II
`
`—
`
`—
`
`Amarin is preparing to commence two phase III trials with Miraxion in Huntington’s disease late in the second quarter of this year.
`Amarin intends to utilize the data from these trials to support an application for marketing approval to the U.S. and E.U. regulatory
`authorities. In Europe, prior to its acquisition by Amarin, Laxdale submitted a marketing approval application based upon the initial
`phase III study. Amarin has decided to voluntarily withdraw that application and plans to re-submit when data from the two planned
`phase III trials is available. Miraxion has been granted Fast Track designation by the U.S. Food and Drug Administration and has
`Orphan Drug status in the U.S. and E.U.
`
`Amarin has partnered the marketing rights to Miraxion for Huntington’s disease in the major European markets and will receive a
`significant double-digit royalty on sales, if approved, in these markets. Amarin intends to directly market Miraxion for Huntington’s
`disease in the U.S.
`
`Miraxion is also in phase II clinical development for treatment-unresponsive depression. Amarin intends to progress development of
`this indication by seeking a development and marketing partner for the U.S. and E.U. markets. Amarin has partnered its intellectual
`property for this indication in the Japanese market.
`
`While Miraxion is Amarin’s core asset and near-term value driver, Amarin has two other products in the phase II stage of development
`and a preclinical programme utilizing its combinatorial lipid technology from which additional next generation phospholipid-based
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`products may emerge.
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`FINANCIAL RESULTS – INCOME STATEMENT
`
`For the fourth quarter, Amarin reported a net loss, including discontinued activities, of $4.8 million, compared with a net loss of $2.8
`million in the fourth quarter of 2003. For the full year 2004, Amarin reported net income, including discontinued activities, of $4.7
`million, compared with a net loss of $19.3 million in 2003.
`
`The results for the quarter and year ended December 31, 2004 are analyzed between continuing and discontinued activities and are set
`out in detail in the three pages of financial tables attached. Amarin’s results include the results of Laxdale from October 8, 2004, being
`the closing date of the acquisition.
`
`Continuing Activities
`
`For continuing activities, the operating loss for the fourth quarter increased to $5.0 million from $0.9 million in the fourth quarter of
`2003. Similarly, the operating loss from continuing activities for the full year 2004 increased to $9.6 million from $6.2 million in
`2003. The increase for both periods is primarily due to:
`
`• the inclusion of Laxdale’s operating expenses in the fourth quarter of $2.2 million for the first time;
`• the inclusion of the previously announced non-recurring payment of $0.9 million to Scarista Limited on October 8, 2004; and
`• the high level of professional fees incurred due to the significant amount of corporate activity in the periods.
`
`The results for continuing activities for the quarter and year ended December 31, 2003 represent Amarin’s head office operating
`expenses, including business and corporate development activities.
`
`Discontinued activities
`
`For the quarter ended December 31, 2004, the loss before interest for discontinued activities was $0.7 million representing year end
`finalization of the loss on disposal of our U.S. operations and of the gain on the settlement with Elan. This compares with a loss before
`interest for discontinued activities for the comparative quarter ended December 31, 2003 of $9.1 million.
`
`For the year ended December 31, 2004, Amarin earned a profit before interest of $21.1 million on discontinued activities compared
`with a loss of $19.5 million for the same period in 2003. The results on discontinued activities for 2004 reflect:
`
`(1) the results of Amarin’s former U.S. business for the period from January 1, 2004 to February 25, 2004, being the date upon which
`the business was sold to Valeant;
`
`(2) an exceptional loss of $3.1 million on disposal of the majority of its U.S. operations and certain products to Valeant;
`
`(3) an exceptional gain of $0.75 million, representing receipt of the final installments of the sale proceeds the disposal of Amarin’s
`Swedish drug delivery business to Watson in October 2003;
`
`
`
`
`
`
`(4) an exceptional gain of $24.6 million on the settlement of debt obligations to Elan;
`
`(5) the costs incurred by Amarin relating to the completion of safety studies on Zelapar (the rights to which are owned by Valeant).
`Following the sale of the majority of Amarin’s U.S. operations to Valeant in the first quarter of 2004, Amarin remained responsible for
`the cost of undertaking safety studies on Zelapar and was liable for up to $2.5 million of development costs. That obligation has been
`fulfilled and Amarin will not incur any more costs relating to the development of Zelapar; and
`
`(6) the settlement of an outstanding dispute with Valeant. As previously announced, Amarin settled its outstanding dispute with
`Valeant in September 2004. The main terms of the settlement agreement are set out in our press release on November 11, 2004
`announcing the results for the third quarter.
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`A non-cash deferred tax accounting charge of $7.5 million on the exceptional gain on the settlement of debt obligations to Elan is
`included in the tax charge for the year ended December 31, 2004. This offsets a deferred tax credit of an equivalent amount included in
`the income statement of the fourth quarter of 2003.
`
`The results for discontinued activities for the fourth quarter and year ended December 31, 2003 reflect the results of Amarin’s disposed
`U.S. operations and Swedish drug delivery business, the gain on the disposal of the Swedish drug delivery business, impairment
`charges on intangible assets related to the disposed U.S. operations and a non-cash deferred tax credit related to the settlement of debt
`obligations with Elan. The U.S. operations and Swedish drug delivery business were disposed in February 2004 and October 2003
`respectively.
`
`Preference share dividend
`
`During the period from 1999 to 2003, Amarin accrued a dividend of $0.6 million on its issued and outstanding preference shares. In
`February 2003, the last of the preference shares were converted into ordinary shares. On conversion the preferential shareholders gave
`up their preferential rights including any rights to an accrued dividend in exchange for the new ordinary shares allotted. Following the
`settlement of debt obligations in 2004, there is no longer a need to maintain an accrual for a preference dividend. As a result, it has
`been written back to the income statement.
`
`FINANCIAL RESULTS – BALANCE SHEET
`
`Intangible fixed asset - Miraxion
`
`Miraxion has an intangible carrying value of $10.3 million, an increase of $6.8 million from $3.5 million at September 30, 2004. The
`increase in the carrying value arises out of the acquisition accounting for Laxdale.
`
`Debt and cash
`
`At December 31, 2004, Amarin had total debt of $2.0 million with a cash maturity in 2009. This is reduced from debt of $35.4 million
`due on demand at December 31, 2003. The $35.4 million of debt was settled in the first quarter as referred to above (see Income
`Statement - discontinued activities) following the sale of Amarin’s U.S. operations in the first quarter of 2004. On September 29,
`2004, Amarin’s non-executive chairman, Mr. Thomas Lynch, signed an agreement with Elan to acquire its remaining debt and equity
`
`
`
`interests in Amarin, including the remaining $5 million of loan notes owed by Amarin to Elan. On October 7, Mr. Lynch agreed to
`convert $3 million of the $5 million of loan notes into 2,717,391 ordinary shares with an option to convert the remaining $2 million at
`the offering price of any future equity financing.
`
`At December 31, 2004 Amarin had cash of $11.0 million compared to $2.1 million at December 31, 2003. On October 7, 2004,
`Amarin raised gross proceeds of $12.75 million through the completion of a private placement of 13,474,945 ordinary shares. Amarin
`is forecast to have sufficient cash to fund the group’s operating activities, including the planned phase III trials for Miraxion in
`Huntington’s disease, through the end of the summer of 2005.
`
`Amarin’s financing strategy will depend on the timing of clinical trial expenditure on its development pipeline and on the level of
`revenue generated from its licensing and partnering activities.
`
`CORPORATE STRATEGY
`
`Amarin’s strategy is to directly commercialize its neurology pipeline in the U.S. and to partner it for geographic markets outside the
`U.S. For indications outside neurology, such as, treatment-unresponsive depression, Amarin will partner its pipeline globally.
`
`Amarin also intends to acquire and in-license neurology products that Amarin can develop and market directly in the U.S. Amarin’s
`goal is to capitalize on its strong reputation in neuroscience and to become a leader in the development and commercialization of novel
`drugs that address unmet medical needs.
`
`About Amarin Corporation
`Amarin Corporation plc is a neuroscience company focused on the development and commercialisation of novel drugs for the
`treatment of central nervous system disorders. Miraxion, Amarin’s lead development compound, is in phase III development for
`Huntington’s disease and in phase II development for treatment-unresponsive depression.
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`For press releases and other corporate information, visit our website at http://www.amarincorp.com.
`
`Statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties which
`may cause the Company’s actual results in future periods to be materially different from any performance suggested herein. Such risks
`and uncertainties include, without limitation, the inherent uncertainty of pharmaceutical research, product development and
`commercialisation, the impact of competitive products and patents, as well as other risks and uncertainties detailed from time to time
`in periodic reports. For more information, please refer to Amarin Corporation’s Annual Report for 2003 on Form 20-F and its Form
`6-Ks as filed with the U.S. Securities and Exchange Commission. The Company assumes no obligation to update information on its
`expectations.
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