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Subsequent Events

On October 16, 2013, the Company announced that an advisory committee to the FDA voted 9 to 2 against recommending approval of the use of Vascepa capsules for the ANCHOR indication based on information presented at the advisory committee meeting. The FDA is scheduled to make its decision on whether to approve the ANCHOR sNDA on the December 20, 2013 PDUFA goal date for the application, however, the FDA could complete its review of the sNDA prior to this date and there can be no assurance that the FDA will complete its review of the sNDA by this date.

On October 22, 2013, in an effort to reduce operating expenses following the recommendation of the advisory committee to the FDA, the Company implemented a worldwide reduction in force of approximately fifty percent of its staff positions worldwide. The majority of affected staff members are sales professionals who have supported the initial commercial launch of Vascepa. The Company estimates that it will incur approximately $3 million in charges related to the reduction in force, all of which includes cash expenditures for one-time termination benefits and associated costs. The Company expects to record the charges in the fourth quarter of 2013 and make the related payments by the end of the first quarter of 2014.

On October 29, 2013, the FDA notified the Company that it has rescinded the ANCHOR study Special Protocol Assessment, or SPA, agreement because in their view a substantial scientific issue essential to determining the effectiveness of Vascepa in the studied population from the ACCORD-Lipid and AIM-HIGH outcome trials, as well as the publicly presented results from the HPS2-THRIVE outcome trial, which the FDA stated in its October 29, 2013 notice to the Company, fail to support the hypothesis that a triglyceride-lowering drug significantly reduces the risk for cardiovascular events among statin-treated patients. Thus, the FDA stated that it no longer considers a change in serum triglyceride levels as sufficient to establish the effectiveness of a drug intended to reduce cardiovascular risk in subjects with serum triglyceride levels below 500 mg/dL.

On November 1, 2013, a purported investor of Amarin filed a putative class action lawsuit against Amarin and the Company’s Chief Executive Officer in the U.S. District Court for the District of New Jersey, Steven Sklar v. Amarin Corporation plc and Joseph S. Zakrzewski, No. 13-cv-6954 (D.N.J. Nov. 1, 2013). The lawsuit alleges that, during the period July 9, 2009 through October 15, 2013, the Company misled investors regarding the FDA’s willingness to approve Vascepa’s ANCHOR indication and the potential relevance of data from the ongoing REDUCE-IT trial to that approval, thereby artificially inflating the price of the Company’s securities. Based on these allegations, the suit asserts claims under the Securities Exchange Act of 1934 and seeks unspecified monetary damages and attorneys’ fees and costs. The Company believes that it has valid defenses and will vigorously defend against the claims.

On November 5, 2013, a purported investor of Amarin filed a putative class action lawsuit against Amarin and certain of the Company’s officers in the U.S. District Court for the Southern District of New York, Joseph A. Bove and Joseph J. Bove v. Amarin Corporation, PLC., Joseph S. Zakrzewski, John F. Thero, and Steven B. Ketchum, No. 13-CIV-7882 (S.D.N.Y. Nov. 5, 2013). The lawsuit alleges, similar to the Sklar case, that, during the period August 8, 2012 until October 16, 2013, the Company misled investors regarding the FDA’s willingness to approve Vascepa’s ANCHOR indication and the potential relevance of data from the ongoing REDUCE-IT trial to that approval, thereby artificially inflating the price of the Company’s securities. Based on these allegations, the suit asserts claims under the Securities Exchange Act of 1934 and seeks unspecified monetary damages and attorneys’ fees and costs. The Company believes that it has valid defenses and will vigorously defend against the claims.