Greetings, and welcome to the Amarin's second quarter 2013 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 Joe Bruno, Director of Investor Relations for Amarin. Thank you Mr. Bruno, you may begin.

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 financial performance and plans for commercialization of our approved products and product candidates including supply related activities and levels of expenditures and revenues and the adequacy of our financial resources, our current expectations regarding regulatory filings, topics and responses to be covered in our upcoming FDA Advisory Committee Meeting, preparation for this meeting, government agency decisions, potential limitations and commercial success of our product and product candidates, our current expectations regarding our cardiovascular outcomes study and the potential implications of such study on our regulatory process, plans to protect the commercial potential of our product candidates and approved products through patents, regulatory exclusivity, trade secrets and existing manufacturing barriers to entry, our current expectations regarding potential strategic collaborations and our expectations for future publication and presentation of our study data. These statements are based on information available to us today, August 8, 2013. We may not actually achieve our goals, carry out our plans or intentions or meet the expectations disclosed in our forward-looking statements. So 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, amend 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 factor section of our most recent Form 10-Q, each of which were filed today with the SEC and are available on our website at 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 its approved indication. Finally, an archive of this call will be posted to the Amarin website in the Investor Relations section. I will now turn the call over to Joe Zakrzewski, Chairman and Chief Executive Officer of Amarin.

Thanks, Joe, and thank you to everyone on the line for joining us today. During this call, we will begin with an overview of our recent accomplishments, including an update on the launch of Vascepa as well as other operational activities. This will be followed by some comments regarding our pending FDA advisory committee meeting and PDUFA date for the ANCHOR indication followed by discussion of Amarin's financial performance in the three and six months ended June 30, 2013. We will also fill questions from analysts and investors, if time permits. 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, Fred Ahlholm, our VP of Finance and Joe Bruno, our Director of Investor Relations. Since our Q1 results call in early May of this year, we have advanced key objectives in a number of areas including recognized GAAP Q2 revenue of $5.5 million for the first complete quarter of Vascepa sales. In addition to this, there is a $1.8 million difference that's above and beyond the $5.5 million. We secured additional formulary access for Vascepa with over 190 million lives now covered by payers without restrictions, including earlier than expected Tier 2 coverage that now totals over 72 million lives. We advanced our planning in preparation for the launch of Vascepa for the ANCHOR indication for patients on statin therapy with mixed dyslipidemia and triglycerides to be between 200 and 499, as we progress towards anticipated FDA approval for the PDUFA date of December 20. We continued to enroll patients in REDUCE-IT cardiovascular outcome study and mean and median base lines for triglyceride levels for patients in the study today are greater than 200 mg/dL, which is consistent with our target and higher than studied in recent…

Thank you, Joe. As you know, the FDA assigned Friday December 20th as the PDUFA date for our ANCHOR indication sNDA. In addition as previously announced, the FDA has scheduled on Wednesday October 16th an Advisory Committee meeting pertaining to our sNDA for the ANCHOR indication. We will be well prepared for the Advisory Committee meeting and we remain confident regarding the approval of Vascepa for the ANCHOR indication. Some investors have asked us why we are having an Advisory Committee Meeting. I remind you that, Amarin had prepared from Advisory Committee Meeting for the MARINE indication, before it was informed that such a meeting would not be conducted. For the MARINE indication, Vascepa was the second drug and its class to be approved, Lovaza being the first and it is understandable why an Advisory Committee Meeting was not held for the severe hypertriglyceridemia indication. For the ANCHOR indication, we got approval for Vascepa to be the first drug in its class to be approved for an indication in mixed dyslipidemia patients with triglyceride levels greater than reported 200 milligrams per deciliter and less than 500 milligrams per deciliter on top of optimized statin therapy. Approximately 40 million adult Americans, or one in five, had triglyceride levels of at least 200 milligrams per deciliter. Given the first of a kind approval being sought and the size and scope of this population, it is understandable why the FDA would recommend in AdCom meeting. Having an AdCom meeting is also consistent with trends that have influenced the FDA to seek greater input and allow greater visibility into its regulatory decision making. Our preparations include obtaining feedback and guidance from leading clinicians in the field and we have already conducted outcomes in an effort to prepare to answer a broad range of questions…

Thank you, Steve. I will provide some commentary regarding our financial results. You will find a more detailed discussion of our results on our 10-Q and press release issued earlier today. Amarin began recognizing revenue from the sale of Vascepa in the U.S. in January 2013, so detail any of the products will not begin until Vascepa's commercial launch on January 28, 2013. We reported net product revenues for the quarter ended June 30, 2013 of $5.5 million as compared to revenue of $2.3 million for the quarter ended March 31, 2013. In accordance with U.S. generally accepted accounting principles, U.S. GAAP, until we have more operating history with the commercialization of Vascepa, we are recognizing revenue not on our sales to wholesalers, but on the retail of Vascepa for the purpose of billing prescriptions. Through June 30th, the net value of the Vascepa sold to wholesalers was $9.6 million. And, as a result, in addition to $7.8 million in recognized revenue, we have recorded deferred revenue of $1.8 million at June 30, 2013. Cash collections from the sale of Vascepa in the quarter ended June 30, 2013 were approximately $6.6 million for total of $9.4 million collected from wholesalers since the launch of Vascepa. Consistent with industry practice, the net price of Vascepa for the six months ended June 30, 2013, reflected the deduction of one-time discounts paid to wholesalers to [sell] Vascepa in advance of Vascepa's launch in January 2013, as well as the cost of our co-payment rebate card program and customary payor rebates and allowances. The net price also includes adjustment for other customary amounts. Cost of goods sold during the quarter ended June 30, 2013 was $2.8 million as compared to $1.3 million for the quarter ended March 31, 2013. Gross margin as a percentage…

Thanks, Fred [ph]. Before we take questions, I want to make some comments regarding our July financing and our current stock price. With respect to the financing, there is never a good time to raise money and raising money through the sale of equity is expensive. Prior to financing, many investors were increasingly communicating to us, that they expected that Amarin would need to do a financing and expressed that they hesitated investing in front of such as transaction. As a result, while we didn't like raising money at the price we did, we decided to get the financing behind us. Moreover, we decided to raise enough money, $121 million in net proceeds, rather than a lesser amount because we wanted to make it clear that we were financing the needs of the company to a level which under most scenarios, would prevent us from having to come back for additional support. Hopefully with this financing overhang removed, our stock price will begin to rebuild to reflect our operational progress, including drive prescription levels and anticipated approvals of the ANCHOR indication. With respect to our stock price, it's trading as a price which does not, in our opinion, reflect that over the past we have gotten approval for the MARINE indication, launched Vascepa and have begun to see meaningful script growth, secured a nearly unprecedented 72 million lives on Tier 2 coverage of managed share, received 27 patents that go into at least 2030 and beyond and continue to diversify and lower cost of supply. We have now demonstrated the feasibility of a Vascepa statin combo. Our outcome study is substantially underway and our sNDA for the ANCHOR indication is accepted and is less than two months away from an AdCom and about four months away from its approval. As…

Thank you. (Operator Instructions) Our first question is from the line of Chris Schott of JPMorgan. Please go ahead with your question.

Great. Thanks, guys, for the questions. Just on lipid molecule front. First, you saw obviously nice uptake in access for Vascepa. Can you elaborate a little bit more on the typical lag you would anticipated between these formulary wins and when we should see this in prescriptions? I am just trying to understand when you are expecting that you will see script growth that properly reflect this coverage expansion and is that something that's happening this quarter or something we should think about later in the year? The second question, similarly on access, will the majority of these 72 million Tier 2 lives and 190 million overall lives also be covered for the ANCHOR indication, similar label expansion, or is that going to be a separate negotiation process? Than the third quarter was just any thoughts you might have on Astra acquisition of Omthera. What that means for the space and competitively what that means for Amarin? Thanks very much.

Hi, Chris. This is Joe. Thanks for the questions and thanks for your support. Regarding the now 72 million lives we have covered on Tier 2, I think I am advised by both that usually takes two months to three months before you start to see real traction. I would like to see it faster, but that's the reality of the business we are in and a lot of that is you are going after the doctors, you are not seeing the patients all the time all the time. It just takes a while to get build up, but two to three months is what estimate. On ANCHOR, I think all the managed care that we have will translate over. In fact, we are being told by a number of the managed plans that once what we get the approval, there will be in many cases, restrictions placed on the competition, because we will be only one with this indication, and by the way any restriction we might have which says, it's only a 500 and above, will go away and all restrictions will go to the competition. So, we expect there to be quite a landslide, if you will, in our favor. Regarding Astra and Omthera. AstraZeneca, you would have to ask those two folks what happened. What we saw was really about a very small $260 million enterprise value of acquisition that was most likely really geared towards Crestor protection rather than triglyceride lowering, but again that's just speculation on our part, but thanks for the question.

The next question is coming from the line of Ritu Baral with Canaccord. Please go ahead with your question.

Hi. This is Kevin for Ritu. Thanks for taking the question. I actually have a follow-up on Chris' question. I was wondering if you can talk a little bit about the breakdown between specialists, say, cardiologists, lipid and pct and how does that breakdown. Also, what are you thinking about ownerships or other BTE activities as PDUFA dates comes around.

I wasn't sure I got the first question.

Sure, is there any trends you see in the prescribing behavior of specialists? Say cardiologist versus methodologist? Or just PCPs?

No, we are seeing access growth and capture across the lipid folks, the endocrinologists and just everyone that's out there. Cardiologists, PCPs. It's not really one group or the other. What I can tell you is, as we look at that's out of 7 to 10 which we are accessing over 30,000 target physicians, we think we got the right reach and we have got the right frequency. It's also important to note that that's the very same group that you are going to for ANCHOR as well. In terms of partnership, no partnership, what we might or might not do. We are still evaluating that as a group, I would also tell you that our position is, that if we continue to focus on the five things I talked about, that's what's really going to drive our success, right. It's going to be, make it happen with initial launch throughout managed care, drive ANCHOR to approval, drive the patent, especially ANCHOR and drive the supply chain. Everything else will take care of itself whether we partner or we don't partner, but those are things we continue to look at as we approach the launch.

Just a clarity on that answer. When Joe said 30,000 patients, I think he meant 30,000 target physicians that we were rolling out.

Yes, I did. Thank you.

Got it, and then a follow-up on REDUCE-IT. I was wondering, if you can tell us where you are in terms of the enrollment?

I am sorry. Can you say that again, please?

For REDUCE-IT, where are you guys in enrollments?

We are well beyond 4,000. Again, we are not prepared to update further at this time for competitive reasons, but well beyond 4,000.

Our next question is from the line of Thomas Wei of Jefferies. Please go ahead with your question.

I just wanted to ask about, if for some reason the FDA or the panel did want to see something on cardiovascular safety, this particular branch of the FDA has looked at diabetes obesity drugs, they sometimes have required a cardiovascular safety analysis to be done, looking at MACE hazard ratios in the upper bound to the 95% confidence interval. So if the FDA, for some reason, wanted you to look at that, could you revise the REDUCE-IT protocol to include an interim analysis for cardiovascular safety and do you know when you might actually have enough data from the trial to rule out a 1.8 or 2.0 upper bound?

Thomas, this is Joe. I am going to let Steve Ketchum our President of R&D take that. But I wanted to just take a minute to make sure everybody knows about Steve's background. Steve has very intimate experiences with the endocrin and metabolism division we are going into. He had several NDAs approved and has worked with this group closely and frankly Steve is, in most of his career, has always been a regulatory expert. So we feel blessed to have Steve on our team in driving that. So, above and beyond all the great data, when you’ve got someone who has dealt with the very group and the very people for so many years, that really goes to our favor. So, Steve, you want to take Thomas' question?

Yes, briefly, Thomas. Obviously the Amarin team was in dialogue on the REDUCE-IT study design across multiple years through IND dialog leading into the SPA. These other therapeutic areas that you were mentioning, in terms of diabetes and obesity where you are obviously aware of the evolution of the requirements over the time and that did overlap some of these other regulatory conversations. So, at no point in time does that factor in to our SPA or other regulatory conversation. So that's not an expectation.

And maybe just a second question. I am sorry I think I have been hoping back and forth between calls here. I missed a little bit of what you said in terms of partnership for ANCHOR. Have you more shifted now towards thinking that you have got that you could do it yourself? How should we think about the different possibilities and where things stand?

I think the possibilities are all the same. So, Thomas, I think if we continue to get to know this market pretty darn well. We are seeing that we have got the right reach and penetration as well as the decile 7 to 10 we are [reaching frequently.] I think we have not made any decisions. We continue to have dialog and we are spending a lot of time both, as a management team and as Board thinking about these. We have got time, we are trying to do the right thing. What we don't want to do is, get into something that doesn't provides the right value if we do that. For example, there are companies out there that are getting a small fraction of what the economics are. This is got to be the right thing for us and any potential partner. I think other than that, I will go back to, we are still working those five things. And if we do those right, everything else will take care of itself, including whether we end up with a partner or not, but we are still sort of thinking about that and working through it. And if and when there is a change, we will make sure that everyone on this call is first to know.

Thanks.

Ladies and gentlemen, we are nearing the end of our monitored question-and-answer session for today and we have time for one more question. That question is coming from the line of [Joel Viti] with Citi. Please go ahead with your question.

Hello. So, this is for [Joel Viti] calling in for Jon. Thanks for taking my question. My first question is, what are the physician metrics that we should focus on the most and would be the most compelling for the commercial impact? Is it total number of prescribers or patient growth position or refill rate or it's something else. Then my second question is, what are the thresholds for improvements to the gross margins and if the ramp is slower than expected with this impact that's having for improvements to these mergers.

I think all those metrics that you mentioned are ones that we look at regularly, number of physicians repeats, NRx's rebuild normalized TRx's, refills, normalized TRx's. What are we doing in terms of target physicians writing versus non-target, super target? So, it's really hard to pin point one or two things. We are really looking at all of them. I think what we like out of it the most is, we continue to see the growth. We continue to see ready access to the physicians' office. There is not a physician out there that's turning this away. We like the anecdotal things, the data things that we are seeing from the physicians where there -- and I got one physician who put himself on the drug. He was on Lovaza. He couldn't get his trigs below 300, they went on our drug and his trigs were below 150. Time and time their datasets like that that are out there and we continue to build momentum, but it is hard to say it's one specific thing you want to measure or look at. I think it's the enthusiasm of our sales professional team, which are doing a great job. And then just really driving into the marketplace, we also look at, how we are doing – we said on the call relative to Eliquis – how you are doing relative to Xarelto and Brilinta and again we there. We are ahead of those, so for that part we feel pretty good. On thresholds or the cost of goods, as we start bringing online the other two to three manufacturers, we will see an instantaneous shift in cost of goods once we get through the inventory of the high cost first supplier. In some way it's volume-driven, because we have certain inventory, but once you get beyond that inventory you are automatically talking about the higher margin products -- higher margin producers. Now once we get to higher and higher volumes, we will continue to drive even further in these efficiencies and one could argue that some of our margin projections that we shared in high 70s to low 80s could actually end up being conservative depending on where we get on volume. So, again, I am not going to give any forecast with what we are going to hit and what our margin is going to be next quarter or the quarter after, but I think the important thing is we now have two very low cost suppliers approved in addition to the first one and we have just submitted last week the fourth supplier. This is the Novasep/Slanmhor/ONC/DSM consortium. So, we are pretty excited about that one and we think our higher margin days are ahead of us.

Thank you. I will now turn the floor back to management for any closing or further comments.

Well, look everybody, it's been great to have everyone on the call today. We are grateful for the commitment and for people sticking with us. I know I will be talking to a number of you over the next couple of days. In fact several of you starting this evening. We are excited and ecstatic and hopefully the next time we are on a call we will be talking about a very, very positive AdCom study. Thank you and good evening.

Thank you. This concludes today's teleconference. You may now disconnect your lines at this time. We thank you for your participation.