Welcome to Amarin Corporation's conference call to discuss its second quarter 2018 financial and operating results. This conference is being recorded today, August 1, 2018. I would now like to turn the conference over to Elisabeth Schwartz, Senior Director of Investor Relations for Amarin.

Thank you all 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 our commercial and financial performance, including levels of Vascepa prescriptions, Vascepa product and licensing revenues, costs and other commercial metrics, gross margin, expenditures and the adequacy of our financial resources, our current expectations regarding our cardiovascular outcomes study, timing of reporting study results, regulatory review and likelihood of success, our plans and preparation for expanded promotion of Vascepa and related market positioning and potential, including the potential for further development and collaboration with Mochida, our plans to purchase additional supply of Vascepa, our goals regarding the timing and scope of international expansion, our current expectations regarding the effect of our co-promotion agreement on our business. These statements are based on information available to us today, August 1, 2018. We may not actually achieve our goals, carry out our plans or intentions, or meet the expectations disclosed in our forward-looking statements. Actual results or events could differ materially. So you should not place undue reliance on these statements. 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 other material agreements 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 Statement section in today's press release and the Risk Factors section of our Quarterly Report on Form 10-Q for the quarter months ended June 30, 2018. These documents have been filed with the SEC and are available through the Investor Relations section of 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 Vascepa outside its approved indication. Please note that we are also providing slides to accompany this morning's call. These slides, which can be found on our website amarincorp.com, in the Investor Relations section under the sub category Events and Presentations, summarize some of the key updates discussed on today's call. Finally, an archive of this call will be posted on the Amarin website, also, in the Investor Relations section. I will now turn the call over to John Thero, President and Chief Executive Officer of Amarin.

Good morning. Today is likely the last time that Amarin will share prepared remarks with you prior to our communicating to the results of the REDUCE-IT cardiovascular outcomes study. We very much forward to learning the results of the REDUCE-IT study and sharing these results with you. For avoidance of doubt, I emphasize that Amarin remains blinded to the results of the REDUCE-IT study. In fact, the Electronic Data key that will enable us and our experts to identify patients as being in the Vascepa arm of the study or the placebo arm of the study remains locked up. Accordingly, nobody has yet seen the final REDUCE-IT results. Some investors have theorized that someone must know the results. No. Nobody yet knows the results. As a reminder, patients and clinical sites do not know whether each patient is administered placebo or Vascepa. The capsules are not marked and indistinguishable and lab tests for the study are performed at a centralized facility and not reported back to the clinical sites. Such lab also doesn't know which patients are on Vascepa and which patients are on placebo. The sorting of capsules between patients is done by a computer algorithm blindly to the patients and clinical sites and blindly to Amarin and the CRO that is helping us manage the study. I recognize that there is speculation that at this late stage, someone must know the trial results. Those involved with running a study and our statisticians assure me that until the data is sorted between patients on the placebo arm of the study and patients on the Vascepa arm of the study, it is not possible to know the results of the study. The blind for the study will not be broken until the database is locked. The need for improved preventative…

Thanks, John. As John mentioned earlier in the call, the second quarter of 2018 showed net product revenue and prescription growth over the corresponding quarter in 2017. Our Q2 net product revenue of $52.5 million was $7.6 million or 17% above the $44.9 million reported for the three months ended June 30, 2017. We recorded net product revenue of $96.3 million and $79.3 million during the six months ended June 30, 2018 and 2017 respectively, an increase of $17 million or 21%. Our rise in Q2 net product revenue was driven primarily by an increase in normalized total Vascepa prescriptions, led by continued productivity improvements by our commercial team. These positive factors were partially offset by patients who did not resume refilling their Vascepa prescriptions, because of beginning of the year insurance deductibles that were higher than last year under some health insurance plans. Based on data provided by Symphony Health Solutions and IQVIA, estimated normalized total Vascepa prescriptions during Q2 2018 increased by approximately 77,000 and 84,000 respectively to 430,000 as provided by both Symphony and IQVIA over the three months ended June 30, 2017. This calculates to associated growth of approximately 22% and 24% respectively over Q2, 2017 and 10% over the first quarter of this year. Licensing revenues recognized by the company were $0.2 million and $0.6 million in the six months ended June 30, 2018 and 2017 respectively, related to timing of milestones and other factors impacting revenue recognition for licensing fees under agreements for the commercialization of Vascepa outside the United States. Gross margin from net product revenue was 76% in the second quarter of 2018 as compared to 75% for the second quarter of 2017. This improvement was driven primarily by lower costs, especially reduced costs for our API. Selling, general and administrative expense…

Thank you, Mike. We look forward to reporting the REDUCE-IT top line results before the end of September. We are working very hard at Amarin to prepare for these results, both with respect to the final steps in completing the REDUCE-IT study and preparing for rapid expansion, assuming positive study results. While we remain blinded to the REDUCE-IT results, we continue to believe that there is substantial epidemiological, genetic and clinical data, supporting positioning of Vascepa, dosed at 4 grams per day to be successful in lowering the rate of cardiovascular events in patients who despite LDL cholesterol control have established cardiovascular risk factors. We will know the results soon. In the interim, I urge investors not to mistake the results of the ASCEND study or the results of meta-analysis of omega-3 mixtures for the results of the REDUCE-IT study. With that, we conclude our prepared remarks. We would like to open the line to some questions. Operator?

[Operator Instructions] Our first question is coming from the line of Louise Chen with Cantor.

I had a few. So my first question here is, we’d often get asked by investors if there's any read-through from the PCSK9 trials to the REDUCE-IT study, maybe you could answer that first and I’ll ask you the other questions that I have? Thanks.

I appreciate the question. I don't believe so, but I've got Steven Ketchum and Craig Granowitz here with me, our Chief Officers in the area of Science and Medical and I’ll ask them if there's anything that they would like to comment on that topic.

Yeah. Thanks, Louise for the comment. It’s Craig Granowitz, Chief Medical Officer at Amarin. We believe that PCSK9 trials really is a separate slimline, cholesterol is different from the risk profile of patients with elevated triglycerides and as you know well, the PCSK9 trial is even lowering LDL down to essentially un-detectible levels or what are considered safe levels in the case of ODYSSEY. About 85% of the residual risk remains. So as we have continually focused that LDL gets you part of the way there, we consider it a cornerstone of therapy, but we believe that the high triglyceride patients still have significant remaining residual risk and then that risk needs to be monitored with therapy like Vascepa, which has a number of effects, which may reduce cardiovascular risk beyond the lowering of triglycerides, the impact as John mentioned in his opening comments on apo B, apo C, lowering CRP and not affecting LDL we believe are unique to EPA and EPA only and those should on a scientific basis validate the hypothesis at the REDUCE-IT study.

And then my second question, thank you for that, is if you could talk about the alpha spend in the interim looks for your REDUCE-IT study?

Sure. For background of folks, we – in conducting the REDUCE-IT study, the first enrollment of patients of which was in December of 2011, we had two interim looks in the study. One of which was at roughly cumulative 60% of the events in the study and the other one, which was around 76% of the events in the study. Amarin did not see any data in conjunction with these interim looks, I guess, I should say, they were also roughly every three months throughout the study, in terms of safety looks conducted as well. All of these looks were reported to us by the independent data committee, which essentially issued a paper with a check mark on it, which said, continue as planned without change to the study. And the study work, there had not been any interim looks. The p value that would need to be achieved relative to the primary endpoint in the study would be p less than 0.05. As a result of the third party reviews that I just referred to, that p value for achieving of the primary endpoint is p less than 0.0436. So, the difference between the 0.05 and 0.0436 is essentially the alpha spend. We think that that tradeoff of fairly modest alpha spend for the operational objectives that we were seeking to achieve by having the interim looks and again, this is a study over a longer of time, having had contact with patients, having rollups of data to be able to test whether those rollups are working, the force function of trying to get events adjudicated and trying to get fall off on missing data, et cetera, we think is important to not wait just to the end of a study. Had we waited to the end of the…

Okay. And thank you. And then just last question if I could please, one quickly. In terms of the top line that you will report by the end of September, what metric are you going to put in to that release and will you host the conference call?

We will likely hold a conference call. We need to see the results, before we can make final determination on what the results reported will be. Our objective is to be truthful and not misleading. So we want to make sure that we are thoughtful in those results. In conjunction with our Phase 3 studies, the MARINE and ANCHOR studies, we ended up reporting a bit more than does maybe a larger pharmaceutical company as a result of the prominence of this study to -- importance of it to Amarin and its shareholders. So, the focus will be on the primary endpoint relative risk reduction, statistical significance. But beyond that, I wouldn't expect this for example to be describing in the top line results related to all of the 30 plus pre-specified secondary and tertiary endpoints, but we think we will be fulsome and can provide valuable information, while also not jeopardizing our ability to get the data published in a top tier Journal. While questions are queued up for others here, but operator, we did promise investors if they sent in questions that we would address some of those. So let me ask one of those here and then unfortunately during our script, prepared comments, we ended up addressing many of them, but I’ll throw one out here just to make sure we're beginning to move forward on that. So question comes in, TRXs are higher in Q2, 2018 than Q4, 2017 but revenues were lower. Why did this occur as the net price of the Vascepa dropped. Let me ask Mike Kalb, our CFO, to address that question.

Sure. Thanks, John. Yes. We are pleased to see record prescription levels as reported by Symphony Health and IQVIA. However, we need to remember that such reports are estimates and these estimates are not always precise. The net price of Vascepa is relatively unchanged and channel inventory levels remain in the ordinary range. The estimates of TRXs tend to become more accurate over longer durations of time.

So one other question that was asked, a small company called Matinas claims that their omega-3 mixture has better bioavailability than Vascepa, should we be worried? In any large market opportunities, there is going to be competition. In many respects, competition can be good. We believe Vascepa will compete well with all of our known potential competitors. Aside from the earlier generation products in the market, our closest competitor is AstraZeneca. They are conducting outcome study of their therapy, which they indicate could be completed in 2019 plus. Matinas is in a much earlier stage, if they get funding and decide to commence an outcome study to compete with Vascepa, they're going to need approximately $300 million or more and probably 7 years or more to do so. We are flattered that they recognize Vascepa as the market leader and that they're attempting to make comparisons to Vascepa. However, as evidenced by other companies, making comparisons based upon PK studies can be misleading and if and when they have more substantial clinical results, we’ll have further comment. Currently, they’re a long way from being a major threat. Operator, was there other questions? I will come back to some of these questions from others, but is there other questions from people who have dialed in?

Thank you. Yes. We do have a question coming from the line of Roger Song with Jefferies.

So, this is Roger for Matt. So I have a couple of questions. The first one is if REDUCD-IT is positive, considering how safe Vascepa is, why my FDA convene adcom and if so, what would they discuss something like clinical meaningful MACE reduction?

So Roger, thanks for the question. It’s the first ever study in this space and in a population which is potentially tens of millions of patients. I know the FDA is interested and it wouldn’t surprise me if they hadn’t had that currently, but let me ask Steven Ketchum, our Chief Scientific Officer, who also oversees, he has tremendous experience in the regulatory affairs area to comment further?

So John, I think, you touched on the most likely reason that FDA might ultimately decide to convene an adcom, given that it's -- the first child design of its kind in terms of prospectively enrolling patients with elevated triglycerides and other CD risk factors and looking at this type of an agent as an add-on to statin therapy. FDA does not make these determinations and tell after an application is received and after its preliminary review, but we would not be surprised, given the aspects that we just mentioned.

In prior communications that we had with FDA around our adcom, following our ANCHOR study and dialog with FDA afterwards, there is tremendous emphasis by FDA on each drug in this space having different effects and challenges making crossover comparisons between drugs and lack of confidence in biomarker. So if there is an outcomes – if there is an adcom, I think it’s actually probably a good thing from the perspective of it, will give an opportunity for the record to be further established that this is not class effect that the effect of Vascepa is unique, such that other therapies looking at the results of what Vascepa is achieving in REDUCE-IT can't claim that they are the same, because the effects of Vascepa are broad and unique. And I think that that’s a some point that would likely be emphasized during an adcom that these results are specific to Vascepa and that other therapies would need their own outcome studies to show results rather than just claiming that they had some of the lipid effects of Vascepa and then were successful. So, I think there are some potential advantages to there being adcom from that perspective.

So my second question is, since you already -- you have said always Teva about the ANDA application. So can you give us some update on other ongoing ANDA litigation?

So, our General Counsel, Joe Kennedy is here. Joe is front and center on those kinds of things. I’ll let Joe comment.

Hi, Roger. Thanks for the question. Yes, we did settle with Teva, allowing them to come in just a few months before the expiration of our patent in 2030. That litigation does continue with Hikma, formerly, West-Ward and DRL. But it’s at a relatively early stage as we just went through a claim construction hearing in April. We haven't heard a judgment out of that. So we don’t have too much to report and of course with ongoing litigation, we don't usually get into the details of that at any stage anyway, but we do have some time before that, we've got good very early stages.

So my last question is about the commercial. So, you started the pilot to increase the awareness of Vascepa, in Q1 and the continuing Q2, just curious, can you provide some quantitative and qualitative feedback and how do you kind of envision you will continue the promotion and show the REDUCE-IT readout?

Sorry, for the benefit of others, I believe what you're referring to is television advertisements that we've been sprinkling out since, I think, the first one appeared on March 28 or thereabout. As a reminder, we view this as being a pilot program, the purpose of which is to increase awareness of Vascepa, but also to improve our understanding of messaging that's working and not working, so that when we seek to broader promotion following REDUCE-IT results, we’re not testing the waters for the first time at that point. As a pilot program, we think we are conducting it with enough frequency to create some awareness, which we've heard that we are and – but the spend for this program, which including design work and running it is somewhere between the $15 million and $20 million prior to knowing REDUCE-IT result, after REDUCE-IT results may increase, which is a fairly modest spend and not -- we're not running these commercials at a rate that is consistent with the level of spend and frequency that would be needed to significantly increase our change behavior pattern. So our hope is that with -- our belief is that with the level of frequency that we are doing it that when REDUCE-IT results are reported out that there will be a general familiarity with what Vascepa is much more broadly than the roughly 20,000 physicians that Amarin sells for, for example, cost climb. And, it's early, but the awareness sampling that we're doing suggests that we're making good progress in that regard and we are also getting survey feedback on what is remembered and not remembered from those commercials so that we have an opportunity to tweak if appropriate that messaging moving forward, when we would continue -- when we would consider spending at a rate that would be more akin to moving the needle on prescription levels, so all that would be considered post REDUCE-IT results, hope that is helpful.

Thank you. We have time for one additional question, which is coming from the line of John Boris with SunTrust Robinson Humphrey.

Thanks for taking the questions and congratulations on nearing the completion of a very -- obviously very important landmark study. Just the first question for Steven Ketchum, just on ANCHOR and MARINE. From -- granted that both of those studies are materially smaller than REDUCE-IT, from the point that you had data lock on those studies, how long did it take to release the top line results.

Hi, John. Thanks. Thanks for your question. I think what's relevant in this context is not only our first hand experience in closing out those 12-week lipid lipoprotein inflammatory marker studies, but also taking a broad survey of recent relevant cardiovascular outcomes trials and I'm speaking of course of trials like [indiscernible] and when you look at those trials and you look at aspects like first patient last visit to data lock or last patient last visit to publication, the information is not always consistent or publicly knowable beyond the sponsor itself, but our timelines are very much consistent with the wind down timing of those other large international cardiovascular outcomes trials. And so I hope that addresses your comment, John.

John, just as a point of reference, if you think about the ODYSSEY trial, it still has not yet been published, even though it was presented. So again, I think these are very complex issues. And we want to be sure and we're working very hard under Steve’s guidance and together with the study PI and the steering committee that we’re really looking to have a concurrent publication in a top tier journal and a presentation at a major medical meeting. We believe that’s what a study, as you brand it, REDUCE-IT being a landmark trial deserves and the medical community deserves for a first in class study of a very large patient group. And this is a sophisticated study with not only primary endpoints, but multiple secondary, tertiary points, we want to get right and sick patients, I mean, some of these patients not only had a primary event, but they've had second and third and fourth events and we’re trying to capture all that information, I mean, the number of data points in the study of 35,000 patient years is enormous and the complexity of these patients where they’ve had elevated cholesterol, many were hypertensive, we’ve got diabetic patients, we’ve got patients with prior cardiovascular events, making sure we get this right is important and we think that the steps we're doing here to get a robust database is supportive of that. Once we know – once that database is locked and we can see that data, it will be rolled up and we've got templates as to watch we think we will see reported and hopefully we can follow those templates very quickly to disclosing of the results, but of course, we want to spend whatever reasonable time is needed to make sure we understand those results before reporting them because we certainly wouldn't want to be reporting something and then saying, oops, we overlooked something important. So, we are highly motivated to get those results out as quickly as possible, but also motivated in trial that's taken this amount of time and cost this amount of money and it's important to society to make sure we get it right. So we will know the results soon, just to reemphasize, today, we are blinded to the results as is everybody else.

So within the press release, will you have any mention of some of the secondary important endpoints like you mentioned during your last quarterly, call such as in diabetic, secondary prevention?

We will look to see whether there is any major inconsistencies in subgroups and if there is anything that we feel as though is required to be communicated to make the results of the primary endpoint not misleading, those are the kinds of things that we would talk about. In terms of statistical quantification of all those various subgroups of which there are many. It’s impossible for us, or it's unlikely to be able to cover them all in a top line result and if we were to do so, we would be jeopardizing publication. But, our objective will be to provide information, which we think is useful and not misleading, but we need to see the results before we can conclude as to what level of communication is necessary to achieve that standard.

And then just on the commercial side, with the potential sales force ramp, do you have an agreement in place with Kowa that expires, can you maybe just remind us when that expires and what your intention is with your partner, Kowa.

So Kowa has worked with us for the last several years in terms of addressing some of the target physicians that we don't have bandwidth to reach out to, there is also some overlap with our salesforce. When we entered into the agreement with Kowa, we specifically -- intentionally structured it, so that it would be terminating here at the end of 2018, as the agreement economics were not built upon REDUCE-IT result. We’re funding REDUCE-IT, and there's a significant upside, which we would anticipate based upon successful REDUCE-IT result, we wouldn’t want to be paying under an agreement at a rate that didn't have that results in there. After we have REDUCE-IT results, we will be evaluating what the best way is to reach customers in a cost effective manner. That includes sales force, it includes digital media. It includes some of the other promotion that we were talking about earlier. We certainly anticipate increasing the number of Amarin sales reps somewhere here in the next two weeks, you will probably see reach a couple of hundred job postings going on or website for open sales positions to be filled after successful REDUCE-IT results and we will be having dialog with Kowa as to whether it makes sense to continue that relationship or not and we’ll continue under what terms, but until we see results, our level of effort and our distribution of efforts between those various buckets remains to be finalized, so too early for us to conclude on that. Our understanding is that they would be interested in continuing, but I really can't speak for them in that regard and until we have results that -- and have specifics that we might want to consider, it's premature. Thanks for those question. Sounds like last, John that was…

Ladies and gentlemen, this does conclude today’s teleconference. Again, we thank you for your participation and you may disconnect your lines at this time.