Greetings, and welcome to the Amarin Corporation Second Quarter 2016 Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder this conference is being recorded. I'd now like to turn the conference over to your host, Kate McNeil, Director of Investor Relations for Amarin Corporation. Thank you. You may begin.

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 prescriptions and wholesalers inventories, revenues, costs and other commercial metrics; gross margins, expenditures and the adequacy of our financial resources; our current expectations regarding litigation; regulatory reviews and government agency decisions, our current expectations regarding our cardiovascular outcome study, such as timing of interim looks, study completion, regulatory review and likelihood of success, our plans to protect the exclusivity and commercial potential of Vascepa, our goals regarding international expansion and other business development opportunities, 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, August 4, 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 section of our Quarterly Report on Form 10-Q for the quarter ended June 30, 2016. These documents have been 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 also providing slides to accompany this morning’s call. These slides which can be found on our website www.amarincorp.com under the category Events and Presentation, which is a subsection under the Investor Relations sections of the website. These slides summarize some of key aspects on today’s call. Finally, an archive of this call will be posted on the Amarin website again in the Investor Relations section. I'll now turn the call over to John Thero, President and Chief Executive Officer of Amarin.

Good morning. Thank you for joining us for an early start. We appreciate that today is a busy day with numerous companies reporting this morning, so we’re going to keep our remarks and focus and concise, first highlighting Amarin’s recent commercial, operational and financial performance and then taking questions from analysts and investors. Similar to Q1, operating results for Q2 again exceed our expectations. The dedication focused execution of our team have resulted in our tenth consecutive quarter of greater than 50% growth in normalized prescriptions compared to the corresponding quarter of the prior year. As a result of this positive performance and associated increases in revenue for the first half of the year, we are raising our guidance on estimated full year 2016 net product revenues through a range of $112 to $125 million. Underlying our growth in product revenue to $32.8 million in Q2 is enhanced sales and marketing productivity as we continue to control our spending, intentionally keeping spending relatively flat for the quarter. This combination of continued revenue growth and expense control allowed us to lower our aggregate net cash burn in the quarter to approximately $9 million. We remain on track to achieve our previously expressed goal of becoming cash flow positive from commercial operations going into 2017, excluding REDUCE-IT and other R&D costs not essential to our current commercial operations. We of course are striving to ultimately become meaningfully cash flow positive covered all expenses including REDUCE-IT interest and royalties. However, we believe getting our commercial business to cash flow positive is an important milestone in our growth and we are pleased to be getting close to this milestone. In Q2, normalized total prescriptions achieved all time high levels and continued to outpace the growth of our competitors. Total normalized Vascepa prescriptions for the…

Thanks John. I am very pleased to be part of the Amarin and look forward to working with the team to help build upon the company’s progress and positive momentum. As Kate mentioned at the start of the call both our most recent 10-Q and today press release can be found on our website. In them you can find more detailed discussion of our second quarter and year-to-date financial results and the highlights I’ll cover in this morning’s call. Overall the second quarter was a strong quarter for the company and both our quarterly and year-to-date results underscore the tremendous growth the company has experienced since last year. Further, as our increase in full year guidance suggest, we see the underlying trends in the business providing the backbone for continued growth in our existing commercial business. During the second quarter, Amarin’s net product revenue increased to $32.8 million and 85% improvement over the $17.7 million reported for the second quarter of 2015. This brings net product revenue for the first six months of the year to$58.1 million compared to $33.3 million for the first half of 2015, an increase of 75%. The core driver of our year-over-year increase as a net product revenue was continued growth in new and recurring Vascepa prescriptions. As John mentioned, this market our tenth consecutive quarter of greater than 50% prescription growth over prior year periods. In addition to our robust organic growth, our business like others is impacted by variability and the level of inventories of our product held by wholesalers. Inventory levels at wholesalers and to fluctuate based on prescription trends and seasonal and other factors. During the first quarter of this year, we saw a decrease in wholesaler inventory levels compared to year-end 2015. In the second quarter, this trend was reversed…

Thank you, Mike. Looking ahead, in addition to update on continued commercial progress, the conduct of the 60% interim look by the DMC is vast approaching. Our research support network assures us that the date should be ready for review by the DMC as early of September in that later than October. When the DMC completes its interim review, they will hand us a piece of paper recommending either to continuous plan or to stop the study. Once we know its recommendation box is checked, we will make the information public. Amarin personnel will not receive the underlying data leading to this recommendation. Everyone involved in the conduct of the study assures me that their confidence in the quality of data REDUCE-IT can generated. We all want to ensure that the trial results is robust. We all agree that the study should only be stopped early if the result with respect to the primary endpoint is robust meeting them remote, challenging statistical hurdle of P less than 0.0076 at the 60% interim look and if this result is supported by robust and consistent data across key secondary endpoint. We remained focused, motivated and confident. I look forward to providing further updates on our progress. With that, we conclude our prepared comments and we’d like to open the line for some questions. Operator?

[Operator Instructions]

Okay, while we wait for our first question to be queued from the operator, let’s take a question that was submitted via e-mail. We received a number of quarries related to the status of REDUCE-IT and the upcoming interim analysis most of which were address directly in the call, if your investors have enquired specifically about the status of database loss for interim analysis, so John perhaps you could just clarify on this point?

Sure. Relative to the database look and the interim look, you know that’s a process that’s being handled independently of Amarin personal. At this point in time, the database is not locked. My understanding is they are going through process of investigating and evaluating data quarries, it’s very common for clinical studies at this stage. Last update I had roughly a 1,000 data enquires that there are still working on, that’s down from about 3,000 a few week ago. When they get to data to the point where they are feeling comfortable with it, there will be codes that get unlocked which then applied to that data and separate the data between those stations which are on placebo versus those patients which are on Vascepa and then the date will be presented to the data monitoring committee to their review. But at this point in time, they are still going through the date quarry portion, they’ve not separated the date between placebo and Vascepa and the database is not locked. As I said in my earlier comments, we anticipate based upon their feedback that they should be in a position to do this as there are only sometime in September, not later than October. We’re obviously looking forward for that update. We have as a reminder and through this process, multiple times previously for safety and not an efficacy look but for safety and each time this process has worked well and the result has been continued its plan. There is at this interim look a safety review and efficacy review, it will be the first efficacy review, there is not a futility analysis.

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

Thanks for taking the questions. John, you mentioned on reduced - thanks for the transparency at least on database lock and the timing around that. First question just has to do with the 3,000 quarries you indicated there about two thirds of the way through those are have about 1,000 left. Can you give maybe any color on timing around resolving those additional 1,000 quarries that are still outstanding? And then secondly on REDUCE-IT, you clearly indicated that the protocol modifications that were made along with the FDA has some beneficial impacts I think you last outlined three things, can you give a little bit more granularity on you know the modifications that have been made here?

I can try all those. Relative to the quarries, we don’t the details of what - in the specific quarries, this is normal, we are conducting this study at 450 sites across the 11 countries. There are language translations, there are following up to ensure that that are appropriately characterized even things like cardiovascular that’s different level of it, it is an immergence there is lots of different details for people to follow up on. We’ve got an experience team working through it, we are intentionally not getting into that level of detail and they are hearing us that they have this ready for the data monitoring committed to take a look at in September or October. So at this juncture, we feel that everything is on track but we again have very limited visibility into the day-to-day portion of that, a 1,000 seems fairly like big number but actually given this quite magnitude of this study, it is really not. With respect to the modifications of the SPA, I think the important points here before I talk about the modification. It is that we remain confident that this trial design is robust. We judge that based upon our valuation of our advisors, based on the fact that the advance rate within the study is very much tracking to our original expectations, you’ll often see cardiovascular outcome studies get to laid and companies come up with various reasons for that but often it suggest that the trial design maybe not have been as robust as had been anticipated. Our trial design appears to be robust. We have also then looking reviews of studies that will come out for other drugs and other areas to make sure we are not overlooking anything. And that is also added to our confidence in…

That’s helpful, John. Just on publication related question on REDUCE-IT, will the - I think you are attempting to get a trail design paper on REDUCE-IT published, any update on the timing and a little bit will the paper include the amendments that were agree to with the FDA upon publication? And then just a couple of commercial questions. If you look at the FDAs, can you just tell us what the position is from the FDA on the use of Vascepa rate going forward, I think there is about 21 million that have been prescribed for fenofibrate and 2015 that’s down 5% from about 22 million plus. What are you doing commercially to capture some of fenofibrate users and get them to be transferred across to Vascepa because of the label for fenofibrate? And then just on your sales force, you indicated you would dramatically increase the sales force if it was positive, can you help us understand sizing of the sales force, possible partnering of your sales force with another sales force out that of Kowa that maybe have some cardiovascular expertise, sharing of large pharma’s assets with your assets that co-promote with you, those types of scenarios around a potential partnership post breaking of the co-agreement?

Alright, that’s quite mortgage broader question. Let me see if I can address them. Regarding the publication, we’ve been publishers, we believe that publication and providing information is valuable. We particularly now with the statistical analysis finalized, think that it’s getting the result published. You know the design published of the REDUCE-IT makes sense. That’s entirely within our control, it’s really a publication that the timing of which really is heavily dependent on the principal investigator and the publisher. So we are going to continue to urge if that gets done but we think it’s valuable. We’ll continue to support that and trying to nudge that forward but can’t predict the specific timing, only say that we are trying to get that - trying to get that done. We’d agree that would be helpful. With respect to fenofibrates, the FDA did cut back on the label of fenofibrates to and removed from that label that they were approved for use some statin therapy, this follows their appealed studies and which was low HDL population. The core study whereby they didn’t hit its primary endpoints and was probably part of the reason why I was setting earlier that there is less confidence in HDL as effective biomarker and more focused on triglyceride here going forward. So that label has been put us back, that product generic at this point in time. Docs been using it for years. We’ve not done head-to-head studies against that particular product but we continued to emphasis our message broad protein benefit not - no LDL increase and certainly fenofibrate have LDL increase. And here we are seeing increasing switches from fenofibrate to Vascepa. And of course the safety profile of Vascepa which is foreseeable like it is in contrast to any of our competitors certainly fenofibrates…

Thank you. [Operator Instructions] Our next question comes from the line of Hugo Ong with Jefferies. Please proceed with your question.

Hey guys, thanks for taking my question and congratulations on a great quarter. Maybe just a quick one question, if you could discuss maybe which geographic regions you’ve been targeting already and which new territories you’ll be focused on next?

Hey, Hugo, thanks for the question. I’ll turn that one over - here are verity of people from Amarin, I’ll turn it over to Aaron Berg, who runs sales and marketing for us. Aaron?

Thank you, John. So right now with a 130 sales reps as you can imagine, we are focused on major metropolitan areas. We have a lot of voice base in the country but we target the highest deciles omega-3 prescribers are also prescribers of fibrates. So fortunately we have a very efficient structure, very efficient alignment where we can get to a bulk of the prescriptions out there in the market through those physicians. But still be very focused in our geographical alignments. As we move forward of course and get into to a post REDUCE-IT area, that will changes you can imagine as John commented on earlier, we’ll expand and that will of course reduce our white space to number of areas well beyond some of the major metropolitan areas.

Okay, great, that’s helpful. And just on REDUCE-IT, for the second interim efficacy analysis, can you disclose the efficacy bar for stopping the trial?

This is John. So similar to at 60% interim look, at the 80% interim look, there will be a statistical hurdle relative to the primary endpoint but also if we hit the primary endpoint, the data monitoring committee will look at secondary endpoints into a robustness and consistency. The statistical bar at the interim look relative to the primary endpoint is be less than 0.0 to 0.2.

Okay, got it. And you touched on this already but I just had a follow-up. So on adding you are over 30 pre-specified secondary and tertiary endpoints, can you discuss sort of which endpoints you see as the most important and clinically MACE?

Certainly primary endpoint which is composite made is the most meaningful, but then below that each of those components of MACE, so mortality, total mortality, cardiovascular death, stroke, MI, revascularizations and looking revascularization like type. But beyond that you get into things like total CV events and on test for heart failure and diabetes and hypertension and verity of other lipid and lipoprotein you kind of markers but the composite may definite and it’s individual components it would be the most important.

Got it, okay. And I think you mentioned that you have a subgroup analysis the men and women for you ANCHOR study similar that you did with MARINE, is any good target meeting that we expect the data?

Let me turn that over to Craig Granowitz, who runs medical affairs for us. Greg?

Yeah, thank you. We’re certainly are preparing data for AHA and that’s certainly that’s one of the topics that we are looking at. Again it would in appropriate for us to comment because ultimately AHA makes a decision and send it for us of what they will accept. We are certainly submitting a host of different data to the AHA meeting and hopefully AHA will view those submissions favorably. I think those topics that John mentioned during his prepared remarks are certainly those areas that we continue to explore scientifically and we think that there is a significant appetite in the medical community to accept those kinds of data submissions and have those data available at AHA.

Okay, great. Thanks for taking my questions.

Thank you. Ladies and gentlemen, we had come to the end of our allotted time for questions. I’d like to turn the floor back to Mr. Thero for final concluding remarks.