Welcome to Amarin Corporation's Conference Call to discuss its Financial and Operating Results for the Fourth Quarter of 2015. This conference is being recorded today, February 25, 2016. I’d now like to turn the conference over to Kate McNeil, Executive Director, Investor Relations for Amarin.

Welcome and thank you for joining us today. Please be aware that this conference call will contain forward-looking statements that are intended to be covered under the safe harbor provided by the Private Securities Litigation Reform Act. Examples of such statements include, but are not limited to, our current expectations regarding our commercial and financial performance, including levels of Vascepa revenues, costs and other commercial metrics; gross margins, expenditures and the adequacy of our financial resources; our current expectations regarding litigation; regulatory reviews, government agency decisions and the potential for label expansion, our current expectations regarding our cardiovascular outcome study, such as timing of physician and likelihood of success. Our plan to protect the exclusivity and commercial potential of Vascepa, our goals regarding international expansion and other business development opportunities, and their current expectations regarding the effect of our co-promotion agreement on our business. These statements are based on information available to us today, February 25, 2016. 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 agreement that we may enter into, amend, or terminate. For additional information concerning the factors that could cause actual results to differ materially, please see the forward-looking statement section in today's press release and the risk factors of our annual report on Form 10-K for the year ended December 31, 2015. These documents have been filed with the SEC and are available through the Investor Relations section of our Web site 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 of its approved indication. Finally, an archive of this call will be posted to the Amarin Web site in the investor relations section. In addition to myself, on today's call from Amarin are John Thero, our President and Chief Executive Officer; Joe Kennedy, our Executive Vice President, General Counsel and Strategic Initiatives; Steve Ketchum, our Vice President of Research and Development and Chief Scientific Officer, Craig Granowitz, our newly appointed Chief Medical Officer, Aaron Berg, our Senior Vice President of Marketing and Sales and Mike Farrell, our Vice President of Finance. I'll now turn the call over to John Thero, President and Chief Executive Officer. John?

Good morning and thank you for joining us. Amarin finished 2015 strong and we’re very upbeat about 2016. During this call, we will review our 2015 results and outline our expectation for Amarin’s continued growth. Looking back, 2015 was a year of strong operational execution and significant progress. Through aggressive and nimble action, Amarin is today much stronger and better positioned than we were a year-ago. Our revenue growth is accelerated. We can promote Vascepa with expanded claims and REDUCE-IT is on track and approaching completion. Further strengthening our commercial operations was a key focus of 2015. Our progress here is evidenced by our prescription revenue growth. During the fourth quarter of 2015, we saw an increase in normalized prescriptions, based upon prescription data from Symphony Health Systems and IMS Health of approximately 52% and 55% respectively compared to the same quarter of 2014. This growth translates to $26.4 million in net product revenue from Vascepa sales, representing a 60% increase over Q4 2014. For the full-year, we achieved net product revenues of $81 million and full-year total revenue of $81.8 million, increases of 49% and 51% respectively over 2014. Broader managed care coverage, dedicated sales and marketing personnel, more than 25 scientific publications and presentations together with expanded Vascepa messaging and promotion, all contributed to our strong Vascepa revenue growth in 2015. Our expanded promotional messaging which started in August and focused on the ANCHOR lipid study results was made possible by our conviction that expanding the flow of accurate information to healthcare professionals regarding Vascepa is in the best interest of patient care. As you know, we pursued the right to such promotion through the federal court system and in August we were granted the authority we select through a federal court declaration. Since August, we’ve used this…

Thank you, John. Our legal victories in 2015 has helped to build a strong foundation for Amarin’s continued commercial growth in 2016 and the years it follow. Of these, the most transformative for Amarin healthcare professionals and most importantly patients was the federal court declaration confirming our right to promote to healthcare professionals, the ANCHOR clinical trial data and to discuss the current state of the scientific research on the potential of Vascepa to reduce the risk of cardiovascular disease. The court order provided us with a specific set of truthful and non-misleading speech to detail the ANCHOR data and consistent with prior case law confirm the peer-reviewed publication like those outlined in the JELIS results are truthful. As the U.S Supreme Court observed in the [indiscernible] case an important First Amendment president, securing First Amendment rights is in the public interest. And that is especially so in the fields of medical and public health were information can save lives. It only furthers the public interest to ensure that decisions about the use of prescription drugs, including off label usage are intelligent and well informed. A physician courted [ph] by the Supreme Court in that case put it this way. We’ve a saying in medicine. Information is power and the more you know, or anyone knows, that better decisions can be made. These sentiments observed is a daily called arms in armory as we work to educate the medical community on the ANCHOR data and in support of, but not conclusive data relevant to the potential of Vascepa to address the significant residual risk in ANCHOR patients. As Aaron Berg will comment in a moment, physicians have expressed to us appreciation for the expanded data we’re presenting to them and for the thoughtful and balanced manner in which it is…

Thank you, Joe. As John mentioned, we had strong Vascepa prescription and revenue growth in Q4. The Q4 revenue of $26.4 million which is an increase of 24% quarter-over-quarter, and 60% year-over-year, was driven primarily by an increase in prescription volume. Our year-over-year quarterly growth was strong throughout 2015, starting with 42% in Q1, 40% in Q2, increasing to 51% in Q3 and finally to 60% in Q4 of 2015. The prescription numbers from Symphony Health Solutions and IMS Health, represent growth of approximately 14% and 15% respectively compared to the quarter ended September 31, 2015, an increase of approximately 52% and 55% respectively compared to the same quarter in 2014. We believe the acceleration in prescription growth in Q4 resulted from a number of factors, some of which were building throughout 2015. These include expanded managed care coverage, positive reports of Vascepa patient experience, high level of customer engagement, low turnover and expanded education of our sales team, as well as our Vascepa co-promotion partner, Kowa Pharmaceuticals America. On top of this growing momentum, our growth in Q4 was expanded by beginning to introduce targeted healthcare professionals to the results of the ANCHOR trial and related supporting data as allowed by the August 2015 First Amendment court ruling that Joe discussed. As we detailed in our last quarterly call, there is a wealth of meaningful data that we can now share with physicians. Enrolling this information out, we’ve been mindful and strategic in our thinking about how best to introduce this information for impact and sustain retention, while also ensuring that data we promote is practical, truthful, and non-misleading. The Amarin and Kowa sales forces began by first educating select healthcare professionals on the results of the Phase III ANCHOR trial in which Vascepa, compared to placebo, improved triglyceride…

Thank you, Aaron. As you can tell from the discussion thus far the continued timely progression of REDUCE-IT is a key priority for Amarin in 2016. So we’re pleased to once again be able to report that REDUCE-IT continues on schedule toward anticipated onset of the predefined target 1612 cumulative primary endpoint event in 2017 and publication of results in 2018. It has been more than six years since REDUCE-IT planning commenced and more than four years since we began enrolling patients in this important study. Throughout the context of this large study, we and our advisors have continued to challenge our trial assumptions. We are reassured that our core assumptions continue to hold up with event rates tracking inline with earlier predictions. This suggests to us that not only is REDUCE-IT well run and well designed, but more importantly that we’re targeting the right high risk patient population, patients who continue to have a residual risk with cardiovascular disease in excess of 60% despite statin therapy and for whom add-on therapy remains a critical mean. As you will recall, the REDUCE-IT study is designed with a composite MACE or major adverse cardiovascular event endpoint comprised of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization or hospitalization for unstable angina caused by myocardial ischemia. The study is 90% powered to detect 15% relative risk reduction, assuming a placebo event rate of 5.2% per year. This doesn’t mean that the study won’t show a greater than 15% decrease in relative risk reduction, or that the trial couldn’t detect relative risk reduction of less than 15%, but it does mean that REDUCE-IT is well powered to detect a level of relative risk reduction with clinicians view to be clinically meaningful. If the REDUCE-IT study is successful, as we believe it will…

Thank you, Steve. My comments will address Amarin’s recent financial results. You will find a more detailed discussion of these results in our 10-K and press release issued earlier today. In Q4 2015, we recognized $26.4 million in net product revenues, representing an increase of 60% as compared to net product revenues of $16.5 million in Q4 of 2014. As previously described, the timing of shipments to wholesalers may vary from period-to-period. Wholesaler inventory levels remain flat during Q4 of 2015 as compared to a previously described slight increase in wholesaler inventory levels during Q4 of 2014. On a year-to-date basis through December 31, 2015, we’ve recognized $81 million in net product revenues as compared to $54.2 million in 2014, an increase of 49%. The level of inventories held by our wholesale customers as of December 31, 2015 was slightly lower as compared to inventories held as of December 31, 2014 based on days of sales on hand. In addition to Vascepa product revenue, we recognized licensing revenue of approximately $800,000 in the year ended December 31, 2015 related to the Eddingpharm development and commercialization agreement t executed in February 2015. The development process in China through Eddingpharm continues to progress consistent with our expectations. Based on data currently available, we estimate that we will recognize net product revenues of $105 million to $120 million in 2016. This estimate is based on available historical data and trends and any significant changes in such trends could result in net product revenues that are lower or higher than our estimates and maybe variable from quarter-to-quarter. Our revenue guidance range for 2016 is somewhat broad, as we’ve less than five months of experience in 2015 promoting Vascepa, after the August court declaration allowed us to commence promotion of results of the ANCHOR study…

Thank you, Mike. As I hope it’s clear by our discussion this morning, all of us remain focused on the success of Vascepa, and in turn Amarin. We have been aggressive and opportunistic in seeking the means by which to grow the company and advance the science of lipid management and cardiovascular health. This diligence was the cornerstone of our success in 2015, and will continue to guide us in 2016. We believe there is a significant opportunity in our existing indication that the full effect of our expanded marketing has yet to be realized, and that with the ever increasing body of scientific literature supporting the benefits of pure-EPA, the commercial opportunity for Vascepa in 2016 looks promising. We believe that the relentless pursuit of these opportunities will be critical drivers of our commercial business and contribute to our goal of entering 2017 cash flow positive from commercial operations excluding REDUCE-IT expenses. While this is not a small exclusion, the return on our investment in REDUCE-IT clearly has the potential to be transformative. This study is progressing well and we are excited by the prospect of becoming the first and only non-statin therapy to have demonstrated a clinically meaningful cardiovascular risk reduction. While our base case continues to be the data from REDUCE-IT will not be available until 2018. We are taking several steps now to ensure that we not only continued to be successful in our pre REDUCE-IT efforts, but that we’re also prepared to hit the ground running once the study concludes. To that end, we have made several key hires in the last several months and have another in the works. Most notably among these is the addition of Dr. Craig Granowitz, as our new Chief Medical Officer. As it’s evidenced by his successful tenure at…

Thank you. At this time, we will be conducting a question-and-answer session. [Operator Instructions]

While we wait for our first question to be queued up from the operator, let’s take a question that was submitted via email. Our first question relates to the First Amendment settlement discussion and is as follows. Why is it taking so long to settle the First Amendment free speech case? Please assess any relationships or issues pertaining to REDUCE-IT interim results and TE Ando cases or other updates or other problems in dealing with the FDA?

We did cover some of that in our opening remarks, but let me turn things over to Joe Kennedy, for just a little bit of further comment.

Okay, thank you, John. As we mentioned in our prepared remarks, we can't get into the detail on the scope and the content of our settlement discussions with respect to the First Amendment other than to reiterate that our goal is to make the preliminary order final. I can't confirm however that the settlement discussions are about the issues that were raised in the First Amendment, the lawsuit itself and not that, that other regulatory matters. For example, it’s not about a way to look at interim data on REDUCE-IT. We are committed to REDUCE-IT separately, because we think it’s the right drug in the right patient population in the right study. Its First Amendment settlement is not about a label change, the only REDUCE-IT for that based on our passed dialogue with FDA. And the First Amendment settlement is not about NCE, which is diminishing importance over time particularly in light of our patents and also because we essentially enjoy a lot of the benefits from NCE in light of some progress separately made with the FDA and through the court system such as the recent dismissal of our Ando litigation. I’ll remind you to make sure that you got the message there that we are -- we continually are able to promote under the First Amendment during and through the settlement negotiation. Thanks.

Okay. Operator, do we have any questions that have queued up?

Thank you. [Operator Instructions] Our first question from the phone comes from the line of John Boris with SunTrust Robinson Humphrey. Please proceed with your question.

Thanks for taking the questions and congratulations on the results. First question for our John and Aaron. If you look at new patient starts and switches that occurred through 2015, can you maybe just help quantify the number of new patient starts and how many of those were switches from Lovaza or Fibrate? A couple of P&L related questions, on the gross margin, you indicated it would be up but if we look sequentially at the pattern it certainly improved, you have a new supplier coming in with more favorable economics. Can you help maybe guide us towards where you think gross margins may come out? Also on tax, what are your current NOLs that you have? And then I have just one more question for, Joe Kennedy.

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No, overall around 15% from the switches, they’re switching in chronic asymptomatic diseases is a little slower. So we’re getting a lot of new patient starts, and in the new patient starts we’re getting a lot of add-ons. So the data is a little convoluted in this area but we get a lot of add-ons for statins and even add-on to other lipid agents. So, I think John, characterized it pretty well overall though.

And then, just a follow-up for Joe Kennedy related to the March 18, deadline. So you’ve been down this path with Judge Engelmayer four times, and when I read his last pre-study published and put out there on pacer it clearly indicated that this was going to be the last time. You’ve kind of soft peddled around saying that your promotion of JELIS was a select promotion on JELIS. It seems like you’re soft peddling on that promotion. It seems like it potentially could be a point of contention with the FDA since it’s the study conducted in Japanese patients. Can you maybe give some clarity as to whether that’s the point of contention that you’re trying to work through with the FDA and what would you anticipate procedurally would happen, should you not resolve this with the FDA. What would happen with Judge Engelmayer?

So, JELIS promotion, I’ll just -- I’ll refer back to the opinion itself. So the opinion itself was based upon the President in Caronia. And with Judge Engelmayer observed in his opinion reasoning is that, Caronia committed off-label promotion of any FDA approved drug for any use. There was no restrictions in, Caronia. That was the reasoning he used in order to get to what was a broad growing in the final order of that case. So when we look at that and we look at the ruling itself and the focus of our litigation, which was focused on promoting to ANCHOR patients, we do use JELIS in promotion now to act as part of the supportive but not conclusive data that shows the connection of Vascepa to cardiovascular risk reduction. We’re not for example promoting JELIS in the United States with respect to its use in Japanese patients or people who have a Japanese type diet and are in Japanese level meds. So that’s the context in which we use JELIS. Okay, I’m not going to get into the back and forth pieces of negotiation, but I hope that does adjust any ambiguity that was left in the air with respect our promotion in JELIS. We are promoting on JELIS in a truthful and non-misleading way. And with respect to the processes to whether we continue -- I think the question, if I recall it correct and you’ll correct me if I didn’t, is what happens to -- with regards to process, if we do continue the litigation? It’s really up to the parties, if we could at Amarin move to, not take additional discovery and agree with the government on that, and to just move forward in the litigation based upon which typically sees the summary judgment. We agreed to all the facts, just as a matter of law is it within our rights under the First Amendment to continue the truthful and non-misleading promotion of, Vascepa. The same question that was addressed in the preliminary order, the preliminary order was the result of expedited proceedings that essentially is a system within the court that where you get down to the net ingredient short order. The underlying cases is a system where you could end up in discovery. FDA can take discovery of us with respect to matters, a hand relative to the suite. We could take discovery of FDA with respect to matters at hand relative to the suite. And so when -- shortly after the preliminary order was issued, the parties got together and thought that the rational thing to do here is to move to discuss settlement terms. I think we have to take a step back and recognize that this has been -- recognize it’s a pretty important case for FDA and they want to do things right and obviously its important case for Amarin. We want to do things right, and without getting a detail that has taken time.

Just to add on add on, I know John, you’re interested in the JELIS data. In our comments we talked a lot about how we work. We’ve taken a very thoughtful approach ensuring that the data we’re presenting is truthful and non-misleading and we do believe that the JELIS data is supportive to the ANCHOR results with that population. But just for context, at the end of the year or the end of 2015, our sales force had called on our top targets. About 25% of them wants, some of them too go ties, but we’re relatively early in the communication of that information to our targets. We have wanted to make sure that they understood the ANCHOR information first before we’re adding the JELIS information on to that. Our co-promotion partner, Kowa, as you recall they have a broader reach lower frequency than we have so more time was required to get some of the ANCHOR data out. Their sales team was thoroughly trained here in late January relative to the JELIS data. So they’re just beginning to launch that data in compliment to the ANCHOR data here recently. So, it’s still fairly early in the education of healthcare professionals with regard to that data.

That’s great color. Just one last question, I’ll hop back in the queue. On intent to prescribe in your primary market research that you’ve done with high prescribing physicians; when you layout the product concept of 19% relative risk reduction and up to 52% relative risk reduction in the population, what is coming out as far as intent to prescribe from those physicians. Is it high, medium, low? Just any …

Very high.

Very high?

Yes.

Okay. Thank you.

Anything in double digits is very attractive to clinicians that we’ve had researched through -- from.

Thank you. [Operator Instructions].

Wait, let’s turn back to some email questions for a moment while we see if there are any more questions, but I know we’re running tight on time here. We’ve received a few questions via our investor relations webpage related to the 967th event in our REDUCE-IT study. Specifically has this event already been achieved and will the company announce when the event has been achieved?

I know that comment came in before our comments here on the -- in the script, we anticipate the onset of the 967th event to occur somewhere here in the first half of 2016. As Steve described, there can be a significant time separation between the time which the event occurs and the time at which it’s formally adjudicated. Guys we have done in this call and we intent to provide regular updates on our REDUCE-IT progress. However there is variability in the adjudication process timing and the time it takes to validate all the data for the independent data monitoring committee to evaluate. And due to this variability, what we’re comfortable at this time in saying is that the 60% interim look will occur in 2016, but for time break [ph] it’s a little too broad at this point for us to be more precise in that regard. For those of you who are following Amarin back at the time we were conduction our Phase III MARINE and ANCHOR studies, you’ll remember there were questions being asked about the timing of the data analysis there. And as you’ll recall, once we have the data, we got it out quickly and we described it robustly. We certainly know that the REDUCE-IT data, it’s important to you, it’s important to us and we intend to get this data out and communicate it as quickly if possible. But relative to the specifics of timing, there’s still a lot of variables at play. And once we have clear picture we’ll try to communicate that to you as well.

Okay. We’re going to try and hit two more of these before we wrap up, but next up we’ve got a question related to our Eddingpharm agreement, specifically asking for an update on the requirements and procedure for bringing a product to market in China? Where we are in this process, and should we expect the milestone payment in 2016 or ’17?

Predicting timing in China can be a bit tricky. Our partner who has a lot of experience there is consulting with China FDA regarding the degree to which clinical trials for Vascepa are required in China. The timeline in those requirements can vary. When we have clarity from China FDA, we’ll let you know what's required and have clearer visibility into the timeline to talk about at that point. While there is some milestones that maybe achieved in 2016 -- in 2017 under agreement. Prior to clarity on what the regulatory path is in China, it’s hard to provide more specifics on that. The milestones that are sort of before the conclusion of the regulatory paths are more modest in dollar amount than certainly than what we had when we initiated the contract. As you maybe aware China is working to shorten its backlog of responses, its response time at this point in time just very tricky to estimate. I would say that in parallel to the Eddingpharm, we are active in talking with potential partners and a variety of other different geographies. As I had commented a bit earlier, there are pros and cons to whether we do something before REDUCE-IT results or after REDUCE-IT results. I’ll take Europe for example. In Europe when -- [indiscernible] which is the name of [indiscernible] over there launch -- it was launched by different companies and different countries and therefore it has different labels, different reimbursement, different dosing. And some of the folks we are talking with would argue, let’s piggyback what's already done there and let’s get the markets quicker based upon the kinds of labels that already exist despite the lower reimbursement. Others would argue, is a much better economics for waiting and going Pan European potentially higher reimbursement rates with outcome study results. We are valuating both approaches and intent to do what we think is in the best interest of overall shareholder value. Some other geography’s aren’t quite as complicated as Europe in terms of that history of existing products in the market place, but we are actively pursuing and there is interest. It’s a matter of finding the right terms for the product, and we believe this product has a huge opportunity and we don’t want to just do a deal to get a deal done. We want to do the right deal.

Okay. Finally, we have two questions seeking comment around our NCE status and associated Ando litigation. So perhaps, you can give everyone a brief update on this front?

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