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Amarin Corporation PLC (AMRN)
Q4 2012 Earnings Conference Call
February 28, 2013, 04:30 PM ET
Joseph S. Zakrzewski - CEO
John Thero - President
Steven Ketchum - President of R&D, SVP
Frederick Ahlholm - VP, Finance and Administration
Joseph Bruno - Senior Director, IR and Corporate Communications
Dewey Steadman - JP Morgan
Thomas Wei - Jefferies & Company, Inc.
Joseph Schwartz - Leerink Swann
Jonathan Eckard - Citigroup Inc.
Previous Statements by AMRN
» Amarin Management Discusses Q3 2012 Results - Earnings Call Transcript
» Amarin's CEO Discusses Q2 2012 Results - Earnings Call Transcript
» Amarin Corporation plc Q2 2008 Earnings Call Transcript
I would now like to turn the conference over to Joe Bruno, Director of Investor Relations and Communications for Amarin.
Welcome and thank you for joining us today. Please be aware that this conference call will contain forward-looking statements that are intended to be covered under the Safe Harbor, provided by the Private Securities Litigation Reform Act. Examples of such statements include, but are not limited to, our current expectations regarding regulatory filings, government agency decisions, potential indications and commercial success for our product candidates and approved products. Our current expectations regarding our cardiovascular outcome study and the potential implications of such study on a regulatory process, plans to protect the commercial potential of our product candidates and approved product per patents, regulatory exclusivity, trade secrets and manufacturing barriers to entry. Our current expectations regarding potential strategic collaborations, manufacturing efforts and preparations for commercialization of our approved product and product candidates, our expectations for future publication and presentation of our study data and our future expenses and the adequacy of our financial resources.
These statements are based on information available to us today, February 28, 2013. We may not actually achieve our goals, carry out our plans or intentions or meet the expectations disclosed in our forward-looking statements and you should not place undue reliance on these statements. Actual results or events could differ materially. We assume no obligation to update these statements as circumstances change. Our forward-looking statements do not reflect the potential impact of significant transactions we may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreement that we may enter into or terminate.
For additional information concerning the factors that could cause actual results to differ materially, please see the forward-looking statements section in today’s press release and the risk factors section of our most recent Form 10-K, each of which were filed today with the SEC and are available on our website amarincorp.com. We encourage everyone to read these documents.
This call is intended for investors in Amarin and is not intended to promote the use of Amarin's Vascepa outside of its approved indication. In addition, please note these remarks will contain non-GAAP financial measures, as defined by SEC Regulation G. The GAAP financial measure most directly comparable to each non-GAAP financial measure used or discussed and a reconciliation of the differences between each non-GAAP financial measure and the comparable GAAP financial measure can be found within our year-end financial results press release. Finally, an archive of this call will be posted to the Amarin website in the Investor Relations section.
I'll now turn the call over to Joe Zakrzewski, Chairman and Chief Executive Officer of Amarin.
Joseph S. Zakrzewski
Thank you, Joe, and welcome to everyone who is joining us today. During this call, we will briefly review our recent accomplishments, update you on Amarin’s operational and financial performance in the fourth quarter and the full-year 2012, and answer a few questions from those on the call.
I am joined on today’s call by John Thero, Amarin’s President; Steve Ketchum, our President of R&D; Fred Ahlholm, our VP of Finance; and Joe and Steve Schultz from Investor Relations.
Since our last quarter, we’ve advanced key objectives in a number of areas, including: the launching of Vascepa in the U.S. for the initial MARINE indication and we began (indiscernible) Commissions on January 28, 2013, our formal initial launch. We hired and trained our sales team, including 275 sale reps, all whom have had extensive selling experience and relationships with healthcare providers targeted for Vascepa.
The Stocked Vascepa at wholesalers and leading pharmacies as part of the initial launch. We’ve achieved greater than a $160 million lives covered by managed care and other payors. Submitted a supplemental sNDA seeking approval in the U.S. for Vascepa second indication, the treatment of high triglyceride levels between 200 and 499 per deciliter for adult patients on statin therapy, also known as the ANCHOR indication. We expect the PDUFA action date by the end of 2013.
We submitted two sNDAs for additional active pharmaceutical ingredient, BASF and Chemport, in addition to submission. We strengthened our supply chain by entering into an exclusive agreement with a consortium of companies, led by Slanmhor Pharmaceuticals, that includes Novasep and DSM to be our fourth supplier.
We increased patents issued or allowed to 18 in the United States, with a majority of the patent terms extending to 2030 and beyond. We are still prosecuting over 30 additional U.S. patent applications, completed dosing in a PK study or a fixed-dose combination of Vascepa and a leading statin. We published additional MARINE and ANCHOR Phase 3 trial results in The American Journal of Cardiovascular Drugs and strengthened our balance sheet through successful completion of a $100 million non-dilutive, hybrid debt financing resulting in a year-end cash balance of approximately $260 million.
Before I continue my remarks, I want to make a point of saying that launching Vascepa is a combination of many years of hard work and commitment by our dedicated team of professionals in Amarin, input from key opinion leaders, and significant investment by our shareholders. We are very optimistic about the future of Vascepa and I want to thank everyone who has helped us get to this stage.