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Q3 2012 Earnings Call
November 08, 2012 4:30 pm ET
Stephen D. Schultz - Senior Director Investor Relations & Corporate Communications
Joseph S. Zakrzewski - Executive Chairman and Chief Executive Officer
Frederick Ahlholm - Vice President of Finance and Administration
Thomas Wei - Jefferies & Company, Inc., Research Division
Joseph P. Schwartz - Leerink Swann LLC, Research Division
Ritu Baral - Canaccord Genuity, Research Division
» Amarin Corporation plc Q2 2008 Earnings Call Transcript
» CareFusion Management Discusses Q1 2013 Results - Earnings Call Transcript
It is now my pleasure to introduce your host, Steve Schultz, Director of Investor Relations for Amarin Corporation. Thank you, Mr. Schulz. You may begin.
Stephen D. Schultz
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 product. 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 by obtaining patents and regulatory exclusivity, maintaining trade secrets and taking advantage of 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 as of today, November 8, 2012. 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-Q, 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 not intended to promote the use of Amarin's Vascepa outside of its approved indication.
In addition, please note that 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 third quarter 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, Steve, and welcome to everyone who is joining us today. During this call, we will briefly review our recent accomplishments, update you on Amarin's financial performance in the third quarter of 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; Joe Kennedy, our General Counsel; and Fred Ahlholm, our VP of Finance.
Since our last quarter, we have advanced key objectives in a number of areas, including: FDA approval of Vascepa capsules as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia; 8 patents, either issued or allowed within the United States Patent and Trademark Office, in addition to over 30 U.S. patent applications pending; receipt of an Intention to Grant of a European patent related to the MARINE Phase 3 trial findings; while continuing to evaluate 3 paths to commercialization and acquisition of Amarin, a strategic collaboration, or self-commercialization, the latter of which could include third-party support, continuing preparedness for early Q1 2013 Vascepa launch, including inventory purchases, managed care outreach and management expansion;
publication of ANCHOR Phase 3 trial results in the American Journal Cardiology; the publication of additional MARINE Phase 3 trial results in its Journal of Clinical Lipidology; and most recently this week, presentation of Vascepa Phase III clinical data at the American Heart Association Scientific Sessions; received regulatory approval of Catalent, as a second drug product encapsulator; and as previously communicated, making good progress on REDUCE-IT enrollment, which continues to support the projected Prescription Drug User Fee Act action date for ANCHOR before the end of 2013.
While these achievements are significant, we have done this while carefully managing our spending. As a result, we ended September with a cash balance of $215.1 million. As there may be some new investors on the call today, I remind you that on July 26, 2012, the scheduled PDUFA date, FDA-approved Vascepa, which was formerly known as AMR101, for what we refer to as the MARINE indication, used as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia, which is triglycerides greater than or equal to 500 mg/dL. No adverse reactions were reported at the incidence level of 3%. In fact, only one incidence was slightly greater than placebo. That was for arthralgia and that incidence rate was 2%.