Welcome to Amarin Corporation's conference call to discuss its Third Quarter 2018 Financial and Operating Results. This conference is being recorded today, November 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 for scientific presentations, publications regulatory reviews and related timing thereof, our expectations that reduces results could lead to a new treatment paradigm and the patient population studies, our plans and preparation for expanded promotion of Vascepa and related market positioning and potential, including the potential for further development in 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. The current plan for salesforce and other commercial expansion. These statements are based on information available to us today, November 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 ended September 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. It's an exciting and busy time at Amarin as we take steps towards expanded promotion of Vascepa and prepare for presentation of details of the REDUCE-IT study on November 10th at the 2018 scientific sessions of the American Heart Association. We appreciate that many healthcare professionals and investors have inquired about more detailed results of the REDUCE-IT study. We have promised AHA, which is American Heart Association that we will save reporting of further details regarding these landmark results for presentation at their Medical Congress on November 10th. Following our announcement of top-line results on September 24th, we have repeatedly stated that we look forward to presentation of additional details at the AHA Scientific Sessions. That remains true. We will not be announcing further results of the REDUCE-IT study on this call today. The presentation at AHA is scheduled for 2:18 PM Central Time on Saturday November 10th. Dr. Deepak Bhatt of Brigham Women's Hospital. The Principal Investigator for REDUCE-IT plans to present REDUCE-IT results in more detail as part of the AHA's lineup of lead breaking clinical trial results. We will follow the AHA presentation with the press release and an investor conference call. In a press release we issued last Friday, we provided information regarding REDUCE-IT related presentations at and around AHA, including timing and access information for Amarin's conference call scheduled for Saturday November 10th. During that call, we intend to review REDUCE-IT results as presented at AHA earlier that day. We hope that investors and analysts will join that call. If you miss it, a tape recording will be made available via Amarin's website. The presentation of REDUCE-IT results at AHA is scheduled to immediately follow presentation of the results of the VITAL study. VITAL as you may recall is another cardiovascular outcome studies…

Thanks John. As John mentioned earlier in the call, our financial results for the third quarter of 2018 reflect a period of operative since that did not benefit from REDUCE-IT results or the expansion of our commercial efforts following such results. Nonetheless, we reported continued product revenue and strict growth in Q3, 2018 over the corresponding quarter in 2017. Our Q3, 2018 net product revenue of $55 million was $7.9 million or 17% above the amount we reported in Q3, 2017. Our net product revenue for the nine months ended September 30, 2018 was $151.3 million an increase of $24.9 million or 20% above the amount we reported for the same period of last year. Our rising Q3 net product revenue was driven primarily by an increase in normalized in 30 days supply total Vascepa prescriptions led by continued productivity improvements by our commercial team. Based on data provided by Symphony Health Solutions and IQVIA, estimated normalized total Vascepa prescriptions during Q3 2018 increased by approximately 74,000 and 83,000 respectively to 458,000 and 457,000 respectively, as provided by both Symphony and IQVIA over the three months ended September 30, 2017. This calculates to associated growth of approximately 19% and 22% respectively over Q3, 2017 and 7% and 6% respectively over the second quarter of this year. As stated previously, Amarin at this time is not providing any quantified guidance regarding product revenues for the balance of 2018 or beyond. While we are optimistic that the demand from Vascepa will meaningfully increase once results of the REDUCE-IT study or understood. Before we can provide reliable guidance, we need feedback from physicians after REDUCE-IT results are presented, published and understood. As John stated, we are increasing the size of our sales team. We expect this expanded team to be trained fully in…

Thank you, Mike. For all of you who are on this call, we appreciate your interest in Amarin. We look forward to speaking with you again on November 10th with respect to the reporting of REDUCE-IT results at AHA. In parallel, please be assured that we are taking broad steps towards building on our strong scientific and commercial foundation to educate healthcare professionals about Vascepa and to help more patients. As touched on my opening comments, we eagerly look forward to the presentation of results from REDUCE-IT at AHA. However, we will not respond in substance to any questions who seek additional insight on REDUCE-IT data beyond that which we provided in our press release on September 24th. With that, we conclude our prepared comments. We would like to open the line to some questions. Operator?

Thank you. [Operator Instructions] Our first question comes from the line of Louise Chen with Cantor Fitzgerald. Please proceed with your question.

Hi, thanks for taking my two questions here. So first question I had was could you give us more color on the size of the OUS opportunity for Vascepa? How it compares to the U.S. and the timing of when you might expand? I know you gave some color already earlier in the call. And second question I had is we get a lot of questions on the IP for Vascepa and if you could, let us know what the next steps are with respect trials and anything else that you are pursuing there, that would be great? Thank you.

Louise good morning it's John. Thanks for the questions. I will pick on the first one and the Joe Kennedy our General Counsel will talk about the IP side of things and some recent activity we have had there. So heart disease, cardiovascular disease is unfortunately a worldwide phenomenon and we have I think large potential opportunities throughout the world. We have got terrific partners in China where they are funding and conducting a clinical trial for Vascepa. We have got a partner in the Middle East where we have gotten approval already in two countries and we not long ago signed up a partner for Canada. We had talked about previously way until we had REDUCE-IT results to consider opportunities in other markets that we have had expressions of interest from other markets and we will be pursuing those potential opportunities. Europe, for example is a area where the earlier generation therapy of Lovaza which is marketed as there as [indiscernible] was introduced in each country by a different company and as a result in Europe it has different labeling, different dosing and different reimbursement. And we felt as though waiting and having an opportunity to go for a pan-European approval based upon outcomes data would provide the greatest opportunity for Vascepa in Europe and that is something that we are pursuing of course giving priority to the U.S. opportunity. I will mention as an aside that following the failed ASCEND study of Lovaza, it's our understanding that in Europe there is some questioning going on by regulatory authorities as to whether [indiscernible] should continue to be approved in Europe giving that failed study which was funded by the British - The Heart Institute. So there is a bit of a dynamic landscape going on there. But it's a large global opportunity that being said the largest market is the U.S. market its where we have a direct presence internationally. We are relying on third-parties clinic partner so far and we will be looking forward to adding additional partners. Right now the top priority is getting the results presented at AHA published and then getting our NDA submitted in the early part of 2019 to get approval here in the states. So hope those comments are helpful. Joe Kennedy with regards as a IP related questions.

Sure. Thanks Louise for these question. It just is a big picture reminder, our patents throughout the 2030 we do have settlement agreement with Teva which allows them to enter in the second half of 2029. The end of litigation goes on with two additional litigants. And where we are in that is at in August of this year we just got a claim construction ruling that is the marketing ruling where the definition of the claims are determined by the judge after advocacy on both sides. And then went very favorably for us. We won all the terms with the exception of one which we think has no significance. Reminded that the claims that we have and the patents cover method of use for treating very high triglycerides with ascribed and the expected results of lowering trades without raising LDL. And with those who have been investors with us for a while remember well back in 2012 the prosecution of those patents when they were dubbed, the most large patent prosecutions on Wall Street and there was a lot of back and forth to the patent office and they reviewed not only by the examiner, but by the examiner supervisor, by quality assurance specialists, by quality assurance specialist supervisors and we are part of what was then a special application warning system which was an elite group of reviewers at the patent office have reviewed less than 0.04% of applications, because of the high profile nature of the application. And that was mostly focused on the inventive nature of the subject matter of patents and we emerged from that, of course with the patents there are reaching from in the litigation. And so as we look forward to in this litigation, we expect a trial in the second half of 2019. And where we are right now is that we haven't even finished the fact discovery cut off. So we are at the point where generics are still going through knowing about invention at the invention and all that. And so we are somewhat still relatively in the early stages having had, again that favorable mark. So we feel pretty good about that and there is really nothing significant is going to be seen from the outside of this until really the second half of next year.

Thank you.

Thank you. Our next question comes in line of Joel Beatty with Citi. Please proceed with your question.

Hi, thanks for taking a question. I believe that Amarin is in a unique position of being able to share some information about - uses of Vascepa with physicians, so could you discuss some feedback from physicians on their initial thoughts of your marketing team sharing information about them with the top-line results of REDUCE-IT? And then also what information are physicians looking forward to from the more detailed REDUCE-IT data presentation? Thanks.

Good morning, Joel. Thanks for the question. So most physicians are not yet familiar with the REDUCE-IT result. As a reminder, we have a relatively small size salesforce, we are rapidly expanding that, but relatively small size salesforce and while we can have some communication of REDUCE-IT the results, the data isn't yet presented or published. So there is limited details out there that we can share at this point in time. We are hearing from physicians who are familiar with these top-line results that they have expressed a high degree of interest, they want to learn more of the details and for many physicians Vascepa is new to them and they seem surprised to learn that the product is affordably priced as it is and covered broadly by insurance and has prescribed over four million times. So I think it's been encouraging feedback so far. They like us and probably you look forward to hearing more and AHA presentation is not that far away at this point.

Okay. And I have follow-up question. Could you discuss the availability of EPA over the counter from other providers and what you can do to help support the use of Vascepa?

So, if you are referring to - when you say over the counter, I think you probably mean dietary supplements, which is really no over the calendar which are kind of something that was previously a drug and overall - and then was given over the counter status. So, relative to dietary supplements. First and foremost, we think that the results of the REDUCE-IT study when they become known to people particularly in light of all the studies dietary supplements and other mixtures including Lovaza will help highlight the divide between the effectiveness of Vascepa and the failed results of these other products. And I would remind folks that it's not just the EA content but it's also a very fragile molecule. It's how its prepared, it's how it's stabilized, it’s how you prevent oxidation or other degradation. There is a lot of science between the product. Beyond that, we are taking action in various ways through the ITC matter, but also through some recent litigation that I will let Joe Kennedy our General Counsel comment on.

Sure. As you might have noticed on Monday, we announced that we sued two relatively small dietary supplement companies based on the [indiscernible] which is a federal law and other state statute that protect this against falsely and you are seeing advertising from dietary supplement is actually a frequently asked questions entry on the IR section of our website that provides a brief summary of those lawsuits and link to the complaints. Those supplement companies as we said - try to use marketing claims based upon REDUCE-IT to help sale their Omega-3 dietary supplement products. And while it's a big industry in the U.S. and most of its from big players, the big players know well that they can’t cross the line under FDA regulations and compare themselves to drugs, or promoted as substitute for drug is actually FDA regulations on that. For example 101-93G26 which prevents comparisons to drug that substitutes. It's also planned out false and misleading to do that. So to compare an Omega-3 supplement to Vascepa for the reasons that are very detailed in that FAQ entry on our IR website. So we are not really concerned for example that the dietary supplement actually going to amass start to use REDUCE-IT and compare themselves for Vascepa, because they know, the subject is not only FDA liability but the [indiscernible] liability of the sort that is in that lawsuit. In fact since our lawsuit is on Monday, dietary supplement industry’s lobby CEO was quoted in the press reminding his industry of that back that you can't compare dietary supplements to drug. And so what we have here is really just lessons to smaller players what they call [indiscernible] who basically took a chance that they would be able to get away with it. And so we expected this, we essentially had these punctuated ago waiting for critical masses misleading advertising and we filed suit and we are looking forward to pursuing those and going forward if we see that claims like that you will see more suits and we hope that folks gout the message not only from us in those lawsuits, but also from the dietary supplement industry president. And that is don't compare your dietary supplements to drugs. So I think that covers your question. Thanks.

And I will just add on a reminder that dietary supplements are not intended to treat medical conditions, the patient that we are seeking to treat with Vascepa are sick patients. They ought to be under medical care. Food products which put dietary supplements are perfect for what they do on the - eat my oat meal or toasted oats and they may or may not be good for heart health, they say that they are foods governed by a different regulatory standards than is drugs and claims they make about maybe helping or at a very different standards. We in turn have demonstrated and overall controlled broad rigorous outcome studies that are in fact does work where studies so far of dietary supplements, Neil have shown that they in fact don't work and we are hoping that the scientific differentiation becomes clear, because for patients who have serious medical conditions, we wouldn't want them to be fooled by thinking that just the food alone is going to be sufficient to address their medical conditions. It’s with the REDUCE-IT results an opportunity to provide the medical therapy that is a new paradigm in treatment that should really be thought of as very different than the market that dietary supplements are going after and dietary supplements try to cross over will take all actions appropriate to both educate and towards those efforts.

Great, that is helpful. Thank you.

Thank you. Our next question comes from the line of John Boris with SunTrust Robinson Humphrey. Please proceed with your question.

Thanks for taking the questions. First question John just has to do with the current book of business, obviously your salesforce and accounting salesforce hold on different types of physicians. What percent of the current book of businesses with specialists, cardiovascular endocrinologists versus primary care? And you certainly mentioned earlier, that [indiscernible], which gave a lipid-focus a 25% relative risk reduction 25% now for Vascepa, did you have an opportunity to conduct any product concept testing to with high deciles physicians, both specialist and primary care to assess and tend to prescribe? And then second question we will just have to do with supply?

Hey, John, thanks for the questions. So with regard to our historical targets with our salesforce, it's been marketing against biomarkers, which for the last 4.5 years is a 135 reps in the U.S. we did increase that slightly this year to 150 and of course now we are changing that over 400. About 85% of their targets have been GPs. GPs are sort of the first line of treatment for patients with cardiovascular risk and we were targeting a niche group of those physicians and roughly 20,000 in number, who are the higher prescribers of the earlier generations therapy. Beyond that 85% toward GPs, we targeted about 7% cards and maybe 5% endos and the balances sort of a mixture. As we look to the business going forward, we will be targeting over 50,000 physicians and we are increasing our focus on GPs and cards and endos but in somewhat similar proportion with emphasis on high set writers. So people who care about preventative care and we think that with the coverage that we will have, it will cover initially with 400 about half or slightly more than half of the writers of in terms of volume of statin therapy. With respect to market research, we did do extensive market research over the years. The REDUCE-IT study was seven years in conduct and a couple of years we did before end of planning it out. We did quite a bit of research during the course of the study. We have not done comprehensive research after the results yet, because the results aren’t broadly known, we will wait towards until the results are presented, published and understood. Otherwise we are not going to get useful information off of that research. But in the research we conducted prior to results, we…

Yes just on the imply. You have obviously indicated that 2019 you will have enough supply for $1 billion in sales. How many suppliers do you currently have? And then how many suppliers at least going forward? Because we can obviously back into the number of kilos relative to the billion. But if we obviously look at demand going forward are you anticipating - how are you anticipating your supply chain to ramp from the current base of suppliers to additional suppliers either through Scandinavia or in Asia?

So manufacturing of Vascepa is difficult. Not many companies in the world can do it. those who can do it we have good relationships with. I would take a step back, the supply chain is actually pretty complex, you have got the sourcing of the [indiscernible], you have got the processing of the API, the encapsulation that, you have got the packaging of that, and there uniqueness and quality controls and FDA related regulations, but also our standards for sure in some way higher, throughout that. And to do that with an agent, which is this is fragile and avoid damage and provided shelf life for a product that is for four years really requires very significant talents. So the constraining piece to that is the API production and there we have been using three suppliers, they have been working with for a while they are proven and they are each interested in continuing to work with us going forward. As you might imagine, with our REDUCE-IT results, we have fielded floss from them as to how they can expand. We have also had dialogue with potential other suppliers that we could add on top of them. And there is a, I don't want to get into specifics of negotiations with suppliers, but we are looking to ensure that we are working with the best companies to ensure quality, to ensure capacity expansion. And we think we have got choices and we are looking forward to expanding our supply in a manner that should meet market demands.

So, again, if you look at the current kilos that you have to meet the $1 billion, how quickly can you ramp that John to meet demand because it is complex?

Very complex question. It depends upon what size you are trying to ramp it to. If you are starting with Brownfield, it takes about 12 to 14 months to expand, but we are starting in all cases with Brownfield, it would be a better facility or existing and you are adding equipment to in less than that. So, there is a lot of different dynamics involved and we have got to figure out which supplier we are doing it with and what we are willing to pay them for the price of insight. It's not as simple answer to that question at all levels of supply, but it is - expanding a very doable, it's a matter of doing it. And so historically our suppliers have been very interested in doing this and funding it, but with money, I think that capacity is ultimately within the spectrum that we are talking about somewhat unlimited matter of making decision and we got to pick which suppliers we are going to do that with.

Is it possible you could be capacity constraint?

I think I just commented that with resource we are not capacity constraints.

Okay, well, good. Thanks.

Go ahead operator.

[Operator Instructions] Our next question comes from like a Roger Song with Jefferies. Please proceed with your question.

Thank you for taking my question. So I have two questions. The first one is what kind of - just before to prepare the SNDA submission. So what kind of activity on each would be performed, specifically what kind of secondary endpoints to be released at AHA in the publication going to impact this SNDA in your view. Thank you.

Alright. Thanks for question Roger. So, I think the SNDA filing isn't so much a function of our presentation at AHA, it's more a function of our bandwidth. So we have given priority to the presentation at AHA and to publication both of which involved peer review and that process we think positions us best for getting to the SNDA. And the primary endpoint for REDUCE-IT, we remind you that this is a study that was conducted under a special protocol assessment agreement with the FDA pulling together an SNDA for a trial, this magnitude is not as small undertaking, but it requires a lot of work. And while we are doing some preparations in those regards right now, we are most highly focused on getting the presentation done at AHA and getting the results published. With respect to content at AHA, if we start talking about specifics of what we might present at AHA, we are sort of potentially violating what we promised AHA that we wouldn't do. I mean I think it's reasonable to assume that you will see data relative to the underlying pieces of the primary endpoint. But I really can't comment beyond that as doing so might would be inconsistent with what we have promised the AHA in that regard.

Yes sure. I understood. So my next question is beyond Vascepa, REDUCE-IT. So any color on the R&D end like the activity with Mochida and I noticed we ever evaporate in the play regression. So just any color on the additional R&D kind of end?

So, I mean right now our primary emphasis is on getting results presented of the REDUCE-IT study. As we talked about this summer, we are very pleased to have entered into agreement with the Mochida. They are a wonderful company and this combines the scientific powers of the two most advanced companies in this field. We are evaluating a number of different potential opportunities with them. They are in early stages at this point in time, but we do look forward to progressing that with them. The Evaporate study that you referred to is sort of building on the results that we are joining a studying in Japan called the CHERY study. And the CHERY study it show that the addition of [indiscernible] acid which is our active ingredient to statin therapy essentially doubled the prevalence of plaque regression compared to statin alone. The EVAPORATE study is one that was initiated by a number of clinicians who are familiar with Vascepa and we are looking forward to the results of that study, it’s still as we have talked about from a milestone perspective, it's still a year potentially even slightly more than a year away. And it is part of a broad amount of work we have done in recent years to more fully describe the mechanistic effects as it relates to how Vascepa work as a unique I mean single small molecule drug and that includes its effect on endothelial cell function information, foam cell formation and plaque progression. So the EVAPORATE study is looking to further quantify or confirm the effect of Vascepa in that area. We do have a very prolific and capable R&D team. In recent years they have come to me with various ideas of let's consider X, Y & Z and I historically reminded…

Thank you. That concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.