Welcome to Amarin Corporation’s Conference Call to discuss the Third Quarter 2017 Financial and Operating Results. This conference is being recorded today, November 1, 2017. I would now like to turn the conference over to Elisabeth Schwartz, Senior Director Investor Relations for Amarin.

Thank you all for joining us today. Please be aware 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, trends and wholesaler inventories, cost and other commercial metrics, gross margin, expenditures and the adequacy of our financial resources, our current expectations regarding our cardiovascular outcome study, such as timing of study completion, regulatory review and the likelihood of success, our plans and preparation for expanded promotion of Vascepa and related market positioning and potential. Our plan to purchase additional supply of Vascepa, our goals regarding the timing and scope of international expansion and our current expectations regarding the effect of our co-promotion agreement on our business. These statements are based on information available to us today, November 1, 2017. 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 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 quarter ended September 30th, 2017. These documents had be filed with the SEC and are available through the Investor Relations section of our website at www.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 www.amarincorp.com in the Investor Relations section under the heading overview, summarize some of 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. Q3, 2017 was another positive quarter for Amarin both with respect to commercial growth and preparations for anticipated REDUCE-IT success. Product revenue in Q3 achieved a record high for Amarin. Our reported net product revenues of $47.1 million and $126.3 million for the three and nine-months ended September 30, 2017 respectively are consistent with our public guidance of $165 million to $175 million for the full-year 2017, which we provided analogous as an update to our previously issued guidance of $155 million to $165 million. Our potentially game changing cardiovascular outcome study REDUCE-IT which begin in 2011 is now less than a year from completion and reported results. In recent months, there has been considerable activity with respect to advancing REDUCE-IT study and preparing for expansion based upon its results. This activity includes completion of the second and last pre-specified interim efficacy and safely analysis, hiring our first Chief Commercial Officer, advancing planning for expanded commercialization based upon assumed positive REDUCE-IT results, witnessing positive results from studies of other therapies, which add confidence to our expectations regarding REDUCE-IT and observing increased attention to importance of triglyceride reduction and the REDUCE-IT study from the key opinion leaders are cardiology focused forums. The second interim efficacy and safety analysis also referred as an 80% interim look was completed in the August. As expected and consistent with our prior guidance, the recommendation of the independent Data Monitoring Committee from this analysis was to complete the REDUCE-IT study as planned without modification. While this was the expected results and the results, which we guided. I will comment to that further here to help ensure clarity. Amarin and the FDA remain blinded to the data from this interim analysis. The data as intended was only reviewed by the independent Data Monitoring Committee. After…

Thanks, John. As mentioned at the start of the call both our most recent 10Q and today’s press release can be found on our website. In them you can find a more detailed discussion of our third quarter and year-to-date financial results and the highlights I’m speaking to now. As John stated, overall, the third quarter was another strong quarter for the Company. In Q3 2017, estimated normalized prescriptions for Vascepa grew 44% over the same period last year as reported by both Symphony Health Solutions and IMS Health. As is likely true for results at other companies this growth might have been even stronger had it not been for the devastation caused by hurricanes Harvey and Irma. A sizable number of Vascepa prescriptions are in regions heavily affected by these hurricanes. While we may see some lingering impact of these storms on Vascepa prescriptions in Q4. Our most recent data suggests that for the most part the sales teams from these impacted territories by the end of October successfully brought prescriptions back to pre-hurricane levels. We will continue to assess growth trends to determine if there are any longer term affects. Our sympathies throughout to residents of the areas affected by these storms including Puerto Rico. I’m proud to say that Amarin employees have been actively involved in contributing to the rebuilding efforts at impacted areas. We recorded net product revenue of $126.3 million and $90.6 million during the nine-months ended September 30, 2017 and 2016 respectively, an increase of $35.8 million or 40%. This increase in revenue was driven primarily by an increase in estimated normalized total Vascepa prescriptions. There appears to have been little impact on our 2017 results from changes in channel inventory levels. Licensing revenue during the nine-months ended September 30, 2017 and 2016 was…

Thank you, Mike. We are looking forward to continue to provide you with updates regarding Amarin’s progress. We are scheduled to present three investor conferences in coming months, including Jefferies London Healthcare conference in two weeks, City’s Global Healthcare Conference in December and the JP Morgan Healthcare Conference in January. We will webcast any podium presentations we make at these conferences. Hopefully for your comments today have helped to better understand the progress Amarin has reported in the significant upside potential we seek to capture. We now conclude our prepared remarks. We would like to open up the lines for questions. Operator?

Thank you. At this time, we will be conducting a question and answer session. [Operator Instructions]. Our first question is from Louis Chen with Canter Fitzgerald. Please proceed with your question.

Hi. Thanks for taking my questions. I had a few here. The first question I had was if you could tell us what percentage of patients with elevated triglycerides are treated and why the percentage might be so low and what is that percentage [indiscernible]?

Louis, good morning, this is John. If I understand your question, you are asking about the overall treatments of the patients who have elevated triglyceride. So we know from data out there depending upon sorts of the data that one in three to one in four patients in the United States have elevated triglyceride levels. The guidelines break those triglyceride levels treating different stride with 150 below being considered normal, 150 to 200 being considered borderline high which particularly deserves treatment for patients are up. Diabetic 200 to 500 being considered high and 500 and above being considered very high with particular no pancreatitis risk. Currently, the data suggest that only about 4% of patients with elevated triglyceride are treated. And we think that that's due to a number of factors not the least of which is that there has never been an outcome study perceptively conducted in this space. The development in science has for the last couple of decades predominantly focuses on good and bad cholesterol and fortunately the advances in study of LDL or bad cholesterol have proven to be quite fruitful starting with statin and then progressing to a point where it’s generally recognize that lower is better on the LDL side of things. But we know that LDL even when real control per say below 70 is still there is a significant residual risk remaining. And it had been thought that addressing HDL, so to bring bad cholesterol down to brining a good cholesterol which is associated with clearing out of bad cholesterol would be helpful. Multiple studies done there from [indiscernible] CTAP inhibitors. All of which have failed. Underlying from that failing data is suggestive data the sub-populations within certain of those studies were the therapies not only increase HDL but also lower triglyceride…

Okay, thank you. And then my second question here is, why do you think that the adoption of Vascepa outcomes studies are positive will be faster than what we have seen with the PCSK9 and other CD therapies?

That’s a good question. So, yes, I think, when we think about our product, I think, it’s probably more analogous to what we saw with statin therapy than it is with more of a specialty therapy like PCSK9. So we see Vascepa as being much more of a pragmatic therapy. It’s got broad effect, which we have seen and demonstrated in Phase III studies and look forward to having more broadly expressed based upon the outcome study. It’s safe, its affordable. PCSK9s have lots of reimbursement issues at $14,000 per year. It’s oral, so it’s not an ingestible product. It’s intended for the massive. So Amarin’s product, we have got a fairly narrow indication today, but if we were to look at scripts and essentially say put Vascepa at the same starting point at PCSK9 despite there being two players out there on the PCSK9 side of things, the script rates for Vascepa is probably our narrow with the indication and much more limited marketing budget as eclipsed sort of work the level of prescriptions of PCSK9s. So PCSK9s are valuable drugs, they are providing instrumental LDL reduction beyond statin therapy, we are advancing a new paradigm in treatment, they are going further with LDL reduction. We are advancing a new paradigm in treatment trying to address that significant residual risk that exists beyond what can be achieved with LDL reduction, we think with positive outcome results combined with that pragmatic care that we are talking about, pragmatic drugs affective, say, tolerable, affordable, available, all should be helpful. Not to mention that we have got coming up on five years of real experience with the drug. So lots of physicians and patients already have witnessed success with that and that had something to build upon.

Just on the opportunity for Vascepa outside the U.S. and how that compares to the U.S. opportunities, I think you have been making some positive developments in those kinds of relationships. I was just curious how you speak about it.

So heart disease is major throughout the world, I mean, in most geographies. It is number one, number two cause of death. It’s expensive everywhere. Amarin has taken the approach of promoting Vascepa on its own. We have co-promotion partners here in the Kowa pharmaceuticals in the United States, but leverage third-parties elsewhere. We started off in geographies where predominantly there is very limited competition. We see ourselves potentially being the first prescriptions [EPA] (Ph) products in China, for prescription EPA product in Canada and similarly are advancing ourselves to an unique space in the Middle East. In markets where - our marketed drugs outside of the U.S. predominantly as [indiscernible] is out there. We continue to see significant opportunity as well, but we have looked at those spaces and considered to go into those markets based upon our current indication and studies and go sort of country-by-country or do we wait and look at REDUCE-IT results and try to go for a broader label than what that earlier generation therapy has. And this goes to the end of the REDUCE-IT study I think our current leanings are to wait for the REDUCE-IT study and pursue that broader opportunity which should not only gear us potential broader labeling, but also better reimbursement than the earlier generation therapy. So hard to see it's a major issue worldwide, we are prioritized to what we think the biggest opportunity is that we can manage which is the U.S., we are working on partners elsewhere, but the partners elsewhere has a strategic element to it, which I hope you pick from my most recent comments.

Operator?

Okay. Our next question is from Joel Beatty with Citi. Please state your question.

Hi this is Sean calling in for Joel. I would like to thank you for taking my questions. My first question is regarding your new sales force. Could you talked a little bit about why you decided to grow that sales force now, territories of interest and estimated committed growth in the U.S. coverage?

Good morning Sean. So notably, we've been planning and talked for a while about planning towards expanding our sales force significantly after the REDUCE-IT results. So also notably is that we haven't changed sales force size over the last three plus year. So I'm very proud that the team has held, plus very much in control and has grown through increased productivity of that existing team significantly. In our analysis of expansion after REDUCE-IT results, which we've got down to not only geographies, but physician targets. We identified certain geographies where we found sufficient enough physicians targets based upon our current marketing. And again, we've expect that the opportunity will be much broader after REDUCE-IT. But based on our current marketing, where we didn't have to rearrange sales territories of existing reps where we didn't have to bring in an additional sales management to add additional reps. And sales as though given the nature of those territories that those sales reps within a year’s time should be covering their cost. Now sales reps and after REDUCE-IT we would expect to cover the costs even potentially faster, but these were territories that didn't require reorganization of what we are doing elsewhere and while our cash flow coming out of our operating business which Mike described as being positive soon the R&D cost and interest and royalty that’s been modestly positive. We thought it was a decent return on investment by spending it at a limited number of sales reps here in the fourth quarter or early part of the coming year. We don’t expect to see significant impacts from those sales reps in the fourth quarter, but as we get later in 2018 and particularly with REDUCED-IT should be 10 to 20 more sales territories that will be up running. And with good momentum when the REDUCED-IT results come out before the end of the third quarter next year. So hope that makes sense.

Yes. That’s very helpful. Thank you so much. And as a follow-up, in your previous earnings REDUCED-IT guidelines, I guess, the trial come in either Q2 or Q3, but today it’s kind of a narrow to be Q3. How should we think about it, is there opportunity to read out in Q2 or are the new projections decreased cardiac events kind of trending towards Q3. How should we look at that?

Yes, so in our comments we tried to explain that when we do estimates throughout predicting timing of when people are going to have heart attacks and strokes or die or other adverse cardiovascular events is a bit tricky. We are actually quite pleased that in a trial that’s now - some of the patients are coming on six years in this study that are number of events is tracking pretty close, particularly close for a long-term cardiovascular outcome study against our expectations. So when we do the interim analysis, which requires a locking down of a database. We found that where we thought it might be by that point in time 80%. We found it to be closer to 76%. Percentage wise not a big difference, but it does mean that rather than 1,612 events are occurring for a near the end of 2017 or early 2018, it looks like guidance are sort of before the end of the first quarter, which is a little bit of a slip, not a huge slip, but a little bit of a slip on finding again. I think slip may not be the right word, because we are trying to get a robust result. And if we get to the 1,612th events in not the very beginning of Q1, it makes getting the results in the second quarter somewhat unlikely. After we get to the 1,612th event, we need to notify all the clinical sites, they need to bring in all the patients who are still living back to get their vital data collected. That’s a period that in many clinical trials is sort of three months in length. And then we get the data all into the tables and independently viewed and scrubbed and rolled up reviewed by an independent community. They need to write a report on it and then Amarin sees it and then we quickly make the results known publicly. So we are thinking it's much more of a Q3 rather than a Q2 event at this point in time. Hope those comments help.

You know that’s very helpful. Are there any additional granularity on where you expect to file sort of file for revenue guidance with increased sales quarter-over-quarter but possible an impact on degrees in hurricanes even?

So the hurricane is an interesting question. It seems like natural disasters are abundant with fires in parts of California for example. But as you probably recall, Amarin doesn't have sales reps throughout the entirety of the country. We with limited resources have sales reps in concentrated areas. Some of those concentrated areas are areas that have been hit by natural disaster. So Texas, Florida, California [indiscernible] areas. We have seen disruption in those areas, we saw our sales reps displaced for a bit. We have seen pharmacies closed, we saw scripts declined in those areas. As we got to certainly end of October in the Florida and Texas areas, we begin to see prescriptions come back to levels in those areas that were sort of levels where they had been in say August, sort of prescriptions. So that's a as a troth that occurred there and coming back to where you were two months earlier doesn't mean that you are ahead. So hopefully the majority of that impact is behind us, but we are still aware of pharmacies that are closed and the people are struggling with in getting their homes back and worry and they are they spending money medical care versus homes, et cetera. We still need to see where that impact is. I think we have seen enough growth elsewhere in the country to continue to feel comfortable with our existing guidance for the year of $165 million to $175 million. But we do anticipate seeing some continued impact of the hurricanes and fires here in the fourth quarter. we are still evaluating the overall magnitude of that impact.

Thank you so much for answering all my questions. Have a good day. Thanks.

Thank you.

Our next question is from John Borris with SunTrust. Please state your question.

Thanks for taking the questions. First question John, when you look at the most recent trials that reported out for example, you mentioned one of REVEAL, IMPROVE-IT. Merck gave commentary that the majority of the benefit at least in those trials occurred towards the very end of the trial. Are you benchmarking against those trials and what conclusions can you draw from benchmarking against some of these outcome studies based on the events and the slowing of the progression of the events. Just second question related to the 76% that you've mentioned. Just can you reiterate the timing for when you think you will hit the 100% of events based on the pace at which they are coming in? And then is it a couple of quarters that you need for scrubbing of the data, is that the reason that you pushed it out to 3Q. obviously it seems as though it's a positive because of the slowing that’s occurring. But if you can just give some better clarity around that, that would be real helpful. That's first question.

Thanks, John. Let me take your second piece first, which is dealing with the timing and then I will ask our Chief Medical Officer, Craig Granowitz to jump in a little bit on studies from others that you referenced. So with regard to timing of events in the REDUCE-IT study, we currently anticipate - this is an estimate based upon experience and modeling that based upon our own experience as well as experiences from other studies. We currently anticipate the 1612th primary mase events, which is a target for completion of the study being reached somewhere before the end of the first quarter. After we reach that event, we will notify either the clinical sites, they will invite remaining living patients in the study back in for their blood work and another updates of data. That’s the process that in outcome studies typically around a three month process and then data gets rolled up into databases, scrubs presented to an independent data committee may write a report and then present it to Amarin. And we anticipate that the sum of all of that activity, which also includes the final adjudication of events, et cetera gets us to having data to report somewhere before the end of the third quarter of 2018. Hope that makes sense. Craig, do you want to jump in on the topic of other studies and impact.

Yes, thank you, John, and thank you for the question. I think there is a sweet spot for follow-up duration in these studies, there is too long and too short. And I think you pointed on one of the studies that went too long which would IMPROVE-IT. And the follow-up period IMPROVE-IT if you look at most experts that are involved the fact that they had increased enrollments several times that they miscalculated the event rates significantly, I think, created some of the quality problems that the Company creates actually in closing out and cleaning up the study. So I think having to make multiple changes to the protocol, reopen enrollment and open additional sites multiple times, which for the patients on therapy as longer and longer follow-ups has an overall deleterious effect on the quality of the study, and actually the relevancy of the study. I think the other extreme that it’s too short and I think the most recent example of that is FOURIER trial where I think everybody acknowledges including the sponsor of the study acknowledges that the follow-up period wasn’t long enough to collect the number of events needed to demonstrate a clinically meaningful difference in event rates between the active arm and the control arm. I do think as it’s been mentioned previously by Amarin, we are looking at a median follow-up period of between four and five years. If you look at many of the most successful large CVOTs particularly the statin trial that is essentially what the median follow-up is. Similar median follow-up period in a number of diabetes outcome studies that have recently come through and for [indiscernible] also had median follow-up periods of around that time. So we feel comfortable that the follow-up period and I’m talking to our steering committee of the physician experts who are overseeing the study that we have about the right sweet spot in terms of duration of follow-up.

That's great, thanks for that. Moving on to one around Vascepa sales for 4Q in particular. If I look at the lower end of your implied range and the upper end, you are looking at 1% growth up to high 20s in terms of growth if you actually looking at TRX trends. There are high-20s low-30s, you factor in price, an assumption of what you realize of that price increases you have taken which were in around the 9% range. It certainly seems as though your guidance seems to be conservative in the fourth quarter, we qualify in that correctly. And then is that because of some assumptions around wholesaler buyouts in the fourth quarter or the impact of the hurricanes from Texas in the upcoming quarter. And then related to that hurricane effect, one would think that since you know the zipcodes and get sales data and volume data on those zipcodes. Can you quantify what the impact since you indicated it was deleterious on your sales. what the impact was in the quarter?

So you have asked a lot there. So relative to our overall guidance for the fourth quarter. We are obviously pleased with our third quarter results, the results in the third quarter were particularly strong. And July and August not as impressive in September, which we think is was impacted by hurricanes. We are still assessing what that impact what was script data comes in on a degree in a granular level of zipcodes that comes in to us on a delayed basis. So it's a something we are still evaluating. And the continued impact of that is something that we are still evaluating as well. We did see in fourth quarter of last year some channel impact and the fourth quarter impact to the upside. We've seen enough quarters in the past where it's gone up or gone down I can't totally be predictive we are not counting on it one way or the other. But on a comparative basis, there were some uptick for channel in the fourth quarter of the last year, we are pleased with this year channel inventory levels of wholesalers has been pretty consistent on a days of sales on hand basis. So we feel as though our guidance of 165 to 175 is the right range based upon what we know today. We are continuing to evaluate and we will always look to do our best to maximize the revenue opportunity.

Thanks for that. Last question just as to I think you initiated a lawsuit about fish oil being imported. Can you just give us some color on why you did that?

So our General Counsel Joe Kennedy is here. I will let him comment on that with the one provides all that [indiscernible] that that particular complaint is against a subset of dietary supplement that are modified and synthetically to which we believe make them drug. This is not a matter that pertains to the majority of dietary supplement of fish oils but Joe, if you want to provide some context.

Sure, yes. Thanks for the question, John. So as John laid out there is overwhelming majority of omega-3 supplements out there or fish-oil supplements, and those are legal supplements. But as we look and field over the years we have seen a lot of products that synthetically alter their products to concentrate EPA in the fish-oil, the DHA and fish-oil together, a higher level of that. And as we look back at the regulatory scheme and FDA’s interpretation that we believe that those products should be classified as drugs under the regulatory scheme. So we see those practice essentially competing in a way that’s unfair. And so we looked at the available options to us and ITC provided an option to exclude from import into the U.S. products that are important things based upon unfair trade competition. We filed our complaint, we recently found out that the ITC decided not to institute the complaint and we are assessing which way to proceed. It is a procedural setback, but I think the genuine substance of the matter we remain confident on and that if you look at the FDA’s interpretation of the statute itself, the FDA’s interpretations over a period of 15 years points to the conclusion that synthetically altered natural products become drugs under the regulatory scheme. And while the FDA weighed in say that they might change that view in the future, it’s clear based upon their multiple interpretations that today a fair interpretation of about the [indiscernible] and regulations that those products should not be out in market without going to FDA drug approval. So, but as John said there is an overwhelming minority segment in the market and as we look forward to the opportunity to REDUCE-IT and the competitive here, we think it’s just simply not appropriate for any parties to be competing with us on the basis of violations of applicable law. And so when we see that we are going to go after them and we will continue to aggressively defend franchise in any way we can, obviously, through patents and in this case through availing ourselves through appropriate regulations and tightening statutes and there are several of them. And we will continue to look around the regulatory schemes to do everything we can to protect the franchise going forward.

Thanks for that and again, congratulations on the results John.

Thanks much. Appreciate it. I think we are probably at a point where we have going beyond what we had set out as being the schedule for this call. So I cut the questions off at this point. Thank you everybody for your interest we look forward to updating you on our further progress and to talking with you soon. Have a wonderful day. bye.

Thank you. This concludes today’s conference. You may disconnect your lines at this time. And thank you for your participation.