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.