During the six months ended June 30, 2013, net cash outflows included approximately $48.2 million paid for sales and marketing related expenses in conjunction with the initial commercial launch of Vascepa, approximately $16.7 million paid in support of the REDUCE-IT cardiovascular outcomes study and approximately $16.3 million for Vascepa API, purchased in conjunction with the buildup of commercial supply and for clinical trial material. Of this $16.3 million in API purchases, $3.0 million was included as a component of research and development expense because it was received from suppliers prior to qualification by the FDA and the balance was capitalized as inventory.
Amarin's liabilities as of June 30, 2013, excluding the fair value of the non-cash warrant derivative liability, totaled approximately $273.0 million, which includes $141.5 million for the carrying value of exchangeable debt and $86.7 million for the carrying value of the hybrid debt financing that we entered into in December 2012.
As of June 30, 2013, Amarin had approximately 150.7 million ADSs outstanding as well as approximately 9.9 million, 11.2 million, and 0.9 million equivalent shares underlying warrants, stock options, and restricted or deferred stock units, respectively, at average exercise prices of $1.44, $7.47 and $8.49, respectively. In addition, $150 million in 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. In conjunction with Amarin's previously announced financing in July 2013, Amarin issued 21.7 million additional ADSs.
Amarin's operational prioritiesOperational priorities in the second half of 2013 are:
- Increasing revenues from sales of Vascepa
- Continuing managed care migration coverage from Tier 3 to Tier 2
- Ensuring a successful ANCHOR advisory committee meeting
- Gaining approval of the ANCHOR indication sNDA; PDUFA date of December 20, 2013
- Planning for the successful commercialization of the ANCHOR indication
- Obtaining additional patent awards from the USPTO
- Continuing development of a fixed-dose combination of Vascepa and a leading statin
- Submitting an sNDA for a fourth API supplier
- Publishing additional data from Amarin's clinical trials
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