Amarin's CEO Discusses Q2 2012 Results - Earnings Call Transcript

Amarin Corporation plc (AMRN)

Q2 2012 Earnings Call

August 8, 2012 4:30 pm ET


Stephen D. Schultz – Investor Relations

Joseph S. Zakrzewski – Chairman and Chief Executive Officer

Frederick W. Ahlholm – Vice President of Finance

Joseph T. Kennedy – Senior Vice President, General Counsel and Secretary, Chief Compliance Officer

Steven Ketchum – President of Research and Development and Senior Vice President


Dewey Steadman – JPMorgan Chase

Tommy B. Nguyen – Jefferies & Co., Inc.

Ram Selvaraju – Aegis Capital Corp.



Greetings and welcome to the Amarin Corp. Second Quarter 2012 Financial and Operating Results Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. (Operator Instructions) As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Steve Schultz, Senior Director of Investor Relations for Amarin Corp. Thank you, Mr. Schultz. You may begin.

Stephen D. Schultz

Welcome, and thank you for joining us today. Please be aware that this conference call will contain 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, regulatory approvals, potential indications and commercial success of our product candidates and approved product, our current expectations regarding the cardiovascular outcome study and the potential implications of any such study on our 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 a potential strategic collaboration, manufacturing efforts and preparations for commercialization of our product candidates and approved product and 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 August 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 that 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 regarding 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 We encourage everyone to read these documents.

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 second 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. I’m joined on this call today by Fred Ahlholm, our VP of Finance; Joe Kennedy, our General Counsel; and Steve Ketchum, Amarin’s President of R&D. On July 26, Amarin held a conference call regarding approval by FDA of our NDA for Vascepa. I hope that each of you had the opportunity to listen to that call. Because that call was so recent and included comments on a variety of topics beyond the NDA approval, I will keep today’s comments brief. Fred will then provide a financial results update and we’ll then take a few questions.

There have been numerous highlights for Amarin since our last quarterly report, most significantly, the recent approval of Vascepa as an adjunct to diet for the treatment of patients with severe hypertriglyceridemia. In addition, Amarin has made significant progress towards supporting the commercial exclusivity of Vascepa with seven patents in play, either issued, allowed or in progress states of prosecution with the USPTO. This in addition to the 25 patent applications that are currently on file with the USPTO.

We received an Intention to Grant letter for the MARINE method of use patent application in Europe as well. We continue to communicate the exciting Phase 3 clinical data from MARINE and ANCHOR trial to the scientific community and past quarter presented at the National Lipid Association, the American Diabetes Association Scientific Sessions and have the ANCHOR trial data published in the American Journal of Cardiology. And through effective cash management in Q2 and prior quarters ended June 30, 2012 with $250 million cash on hand.

Looking ahead, now that Vascepa is approved for the initial indication, Amarin is preparing to file a supplementary NDA, an sNDA for the high triglycerides mixed dyslipidemia indication studies in the ANCHOR Phase 3 trial. The sNDA can be filed when the Amarin’s cardiovascular outcomes study REDUCE-IT that’s substantially underway, which as previously stated, we expect to achieve in 2012.

Amarin continues to consider three potential paths for the marketing and sales of Vascepa: an acquisition of Amarin, a strategic collaboration, or self-commercialization, the latter of which could include third-party support. Until we enter into potential strategic transaction, Vascepa commercialization plans will continue to evolve. We believe that each of these paths can lead to success. We plan to continue evaluating the relative of origin-risk of these paths on a basis of what we believe creates the best value for our shareholders.

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