Welcome to Amarin Corporation’s Conference Call to discuss its financial and operating results for the Third Quarter of 2019. [Operator Instructions] I would like to turn the conference call over to Elisabeth Schwartz, Senior Director of Investor Relations of Amarin.

Good morning. 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 are current expectations regarding our commercial and financial performance, including levels of Vascepa shipments and prescription, Vascepa’s product and licensing revenues, costs and other commercial metrics, gross margin expenditures and the adequacy of our financial resources, our current expectations regarding regulatory reviews, including our expectations related to the upcoming advisory committee meeting regarding our REDUCE-IT sNDA and our expectations for Vascepa label expansion, our current expectations for scientific presentations, publication and related timing thereof, our expectations that REDUCE-IT results could lead to a new treatment paradigm and the patient population studied, our plans and preparation for expanded promotion of Vascepa and related marketing positioning and potential, our plans to purchase additional supply of Vascepa, our goals regarding the timing and scope of international expansion and our current plans for sales force and other commercial expansion. These statements are based on information available to us today, November 5th 2019. 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 when they 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 Statements section in today’s press release and the Risk Factors section of our quarterly reports on Form 10-Q for the quarter ended September 30th 2019. 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 and Amarin 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 at amarincorp.com in the Investor Relations section under the sub-category Events and Presentation, summarize some of the key update 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. Thank you for listening to our comments today regarding Amarin’s third quarter progress in this busy and exciting time. Amarin’s growth was again positive in Q3. We reported record revenue levels, positive cash flow and a strong financial position, while adding to the breadth, depth and experience of our commercial organization. We will comment further on such operating matters during this call. First, I will address our pending sNDA with the U.S. Food and Drug Administration in which we are seeking a cardiovascular risk reduction indication for Vascepa based upon the landmark results of the REDUCE-IT cardiovascular outcome study. The targeted PDUFA date for FDA action on this sNDA is December 28th of this year. As part of its review, the FDA is planning an Advisory Committee meeting or ADCOM to be held on November 14th. We are looking forward to the ADCOM with cautious optimism. The ADCOM should be an opportunity to provide education and insights regarding the differentiated effects of Vascepa, the positive results of REDUCE-IT and the potential to use Vascepa and it’s cardio protective results to help millions of patients. Based upon REDUCE-IT results, if all statin-treated patients in the United States with elevated triglyceride levels were treated with Vascepa, we estimate that major adverse cardiovascular events such as stroke, heart attack and cardiovascular death could in aggregate be reduced by 150,000 to 450,000 per year. We believe that this represent a tremendous potential healthcare improvement, not just for at-risk patients, but also for their families and society. Fewer major adverse cardiovascular events potentially translates into increased productivity and lower healthcare spending for these expensive events and subsequent patient rehabilitation. As we have expressed previously, it is common for the FDA to have ADCOMs in conjunction with first-in-class drug applications such as our sNDA…

Thanks, John. As mentioned at the start of this call, both our Form 10-Q and our press release issued today discussing Amarin’s Q3 results can be found on Amarin’s website. They include details which go beyond the highlights we will cover in this morning’s call. Our third quarter total revenue was $112.4 million. This was a record high for Amarin and an increase of 103% over the same period in 2018. We recorded total revenue of $286.5 million for the nine months ended September 30, 2019. This also was a record high for Amarin and an increase of 89% over the same period in 2018. This nine-month revenue also well exceeds the 12-month total for 2018. As expected, nearly all of our total revenue consisted of product revenue from Vascepa sales in the United States. The increase in net product revenue was nearly all attributable to increases in new and recurring prescriptions of Vascepa. Such prescription levels reached record highs for Vascepa during the reported three and nine-month periods of 2019. The net selling price of Vascepa varies modestly from quarter-to-quarter and was slightly higher in Q3, 2019 than the same quarter of 2018, but remained relatively unchanged for the nine months ended September 30, 2019, as compared to the same period in 2018. The estimated number of normalized total Vascepa prescriptions based on data from Symphony Health and IQVIA, for the three months ended September 30, 2019 were approximately 865,000 and 787,000 respectively compared to 458,000 and 417,000 respectively in the three months ended September 30, 2018. These estimates reflect increases of 89% in the third quarter of 2019 over the same period of 2018. As a reminder, Amarin recognizes product revenue based on sales to regional wholesalers and specialty pharmacy providers in the United States or collectively its…

Thank you, Mike. We are planning for success regarding an expanded label for Vascepa. As previously expressed, we intend to increase the size of Amarin’s U.S. sales force from 400 to 800 sales representatives for the launch of Vascepa for cardiovascular risk reduction assuming FDA approval. In Q3 2019, we hired or internally promoted nearly all of the sales management team needed to support this growth. Included in this expansion is the addition of Joe Balzer as Senior Vice President of National Sales. Joe is very experienced with a track record of success in leading teams, which are much larger than what we are growing to initially. He has surrounded himself with good people, including retention of the sales leadership team responsible for getting us to this stage and who will now manage sales for significant portions of the U.S. under Joe’s overall responsibility. In Q3, we continued to witness increased prescription rates from physicians called on by our veteran Vascepa sales representatives, and by our newest sales representatives. The sales representatives we added near the beginning of this year continued to contribute faster than we initially anticipated. Their progress adds to our confidence as we move to hire and train additional waves of new sales representatives. In recent months, we received over 10,000 job applications for the sales positions we are seeking to hire. We recently added some of these incremental sales representatives. Many of our recent hires are referrals from our existing sales representatives. We are confident that we will be able to recruit and train qualified people to support our planned expansion for launch of Vascepa in early 2020 based upon the cardiovascular risk indication we are seeking in assumed approval of Vascepa on or before the December 28 PDUFA date. Other preparations for this launch beyond…

[Operator Instructions] Thank you. The first question today comes from the line of Yasmeen Rahimi with Roth Capital Partners. Please proceed with your question.

Hi, team. Thank you, John, for your thoughtful prepared remarks in regard to ADCOM procedure and topics. You mentioned in your prepared remarks that some of the questions might be tough versus others. I would love to hear your thoughts on which of the topics we could consider more tough? And then the second question is in regards to EVAPORATE. We’re excited to look at the data at AHA, maybe you can tell us what percentage progression like you expect to see and what is the purpose of this study? Is it just helping us mechanistically support Vascepa or do you plan to utilize the data into the label? And thank you again for taking my question.

Yasmeen, thanks for the questions. Good morning. With respect to ADCOM questions, the nature of an ADCOM really is to bring in advisors to the FDA. These are smart people and they all want to be heard. So there is a sort of natural adversarial tone that goes into those questions. And you can see that count for other products that people opt to ask tough questions at the end. They may have more different views and questions that they ask, but they ask pointed questions, try to get to answers on topics. I think we have good responses and in fact, very good responses to what we think will be the likely question at the meeting, but I – my purpose of mentioning that they’re likely to be tough questions is to, in some respect state the obvious, and to – for those who are potentially attending or listening to the ADCOM not to take out of context difficult question. That’s the nature and purpose of an ADCOM is to be challenge on the data. And we think we’ve been challenged on the data in various medical conferences. We think we’ve been challenged on data and reviews by publications like the New England Journal of Medicine, Journal of American College of Cardiology. And I believe and I think we’ve seen that deeper people dig into the data the stronger the data gets. So tough questions and reference to tough questions is really as a contextual piece, but there is nothing that we’re walking into that ADCOM fearing as being a real got that we’re not prepared to answer. With respect to EVAPORATE, as an investigator initiative study, the mechanism of action of Vascepa is multi-factorial. As you may recall, it was study done in Japan, called the Cherry Study.…

Thank you, team, and best of luck next week, not that you need it.

The next question is coming from the line of Michael Yee with Jefferies. Please proceed with your question.

Hey, John. Congrats on the good quarter and progress so far. Two questions for you. One was related to the commentary around the ADCOM and how you think about a label? It does seem that a lot of the discussion questions you mentioned are perhaps around labeling and population. So could you just level set our expectations as to the – what you expect for what a broad population or broad label is? Is that something like PCSK9 or would you expect that its possible commentary is around primary and secondary prevention or even trig levels? And then as it relates to the second question, can I confirm that you did get a preview briefing document at advance already that you’ve gone through that and that the comments you made are many of the topics that are in that briefing document, including your comments around mineral oil? Thanks so much.

Michael, good morning, thanks for the questions. With regard to documentation that we’ve seen, we’ve had numerous questions from the agency. As you might expect in the FDA review over those multiple months since it was submitted in March. We’ve had various other forms of communication as briefing books at this point in time or not final and we’ve got a pretty good sense of what might be in it from a draft perspective, but they’re not final. And I wouldn’t want to put us a stronger period after something that’s not a final document at this stage. With regard to the ADCOM and questions, I do think that there are likely to be a number of questions, which could be interpreted as questions that would pertain to labeling. That being said, that doesn’t mean that those will be the only questions. And as it pertains to labeling on from a macro perspective, what we’ve studied where statin treated patients with elevated triglycerides and other cardiovascular risk factors. How that is best described to physicians and patients, there are varying opinions on and those varying opinions get into, does it make sense to quantify LDL, does it makes sense to quantify triglyceride levels. So does it make sense in the label to get into definitions or salvage cardiovascular disease and diabetes and other risk factors. And does age matter, there is a – we have a long list of entry criteria that’s used for a clinical outcome study and use those in outcome study to ensure a consistent results across whole forms of study. And then this is not a unique topic, if you get into this, disrupt FDA considerations as to how is that information from an outcome study best communicated to physicians and patients. And there are always varying views on that some – both would prefer to have it – be really left to the judgment of physicians and knowing that physicians understand that patients the best. And if you describe patients being at risk. Docs will know that is, and others think that maybe an indication ought to be more detail than that. We have not entered into labeling is for voice do we not we’ve not entered into labeling discussions with the FDA. It is typical to not enter into those labeling discussions and after – till after ADCOM is complete. But it’s somewhat inescapable during at ADCOM or views not to be shared on topics that could inform FDA’s thinking relative to labeling considerations, whether the FDA chooses to follow those advice of the Committee are not in those matters. So it is – always remains to be seen.

Got it. Thanks.

Our next question comes from the line of Ami Fadia with SVB Leerink. Please proceed with your question.

Hi. Good morning. Congrats on the nice quarter. I had two questions regarding some of the topics you mentioned, John with regards to what might come up at the ADCOM. Firstly, with regards to the patient population, can you talk to the minimum TG level of patients that were enrolled in the REDUCE-IT study? I believe that the SPA was for 200 TG level, but you enrolled patients all the way from 135. Can you talk to sort of some of the considerations that may be involved in thinking about what patients Vascepa would be prescribed for from a labeling perspective? And also what percent of patients in the trial were in that 135 to 200 range? And then separately regarding the interaction between mineral oil and statin, you’ve sort of expressed some of your views on the Company website. But I also wanted to understand, do you believe that it is possible to do some sort of a drug-drug interaction study between mineral oil and statins? And then do you think it would be informative in clarifying that interaction and what type of time and resources may be required to do something like that? Thank you.

Thanks, Ami, for the questions. With respect to the patients' population, the study was designed to use triglycerides as an identifier risk and then now this gets a little bit tricky. And I think you know that this further benefit of other is – we were not trying to demonstrate that lowering triglycerides alone provides all the benefit from the study. So we’ve got triglycerides, which I think are really pretty well established as a marker of risk, but as a modifiable risk factor, still known in the Vascepa has multi-factorial effects with one is triglyceride lowering. When we went into the study REDUCE-IT, we went into the study with a statistical plan and analysis that assumed a lots of different things. We assumed that obviously all the patients are going on statins, all patients in elevated triglycerides. We assume things like 70% or more going to be secondary preventions. 30% are going to be primary prevention. We also had assumptions in our modeling for the sort of number of patients or the balance of patients who might have triglycerides at different levels, so that we would try to get a spectrum of data based upon different triglyceride levels. When we began the study, the threshold was triglycerides 150 above with a 10% allowance of the lower boundary, was effectively 135. When you enroll patients in this study, there is a mark-up that people have at the beginning of the study when they get enrolled, then they go through a wash-out and randomization period and then there is another marker at the measure of their triglycerides at the end of that. And where they’re actually beginning to receive Vascepa therapy or placebo, and during that phase, some patients had triglycerides went up and some down like that we had some…

Today’s call has concluded. Thank you for your participation. You may now disconnect your lines at this time.