Welcome to Amarin Corporation's Conference Call to discuss its Financial and Operating Results for the Third Quarter of 2015. This conference is being recorded today, November 4, 2015. I’d now like to turn the conference over to Mike Farrell, Vice President of Finance 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 sales, revenues, and other commercial metrics; expenditures; supply-related activities; managed care coverage and the adequacy of our financial resources; our current expectations regarding product development internationally; government agency decisions and pending litigation; our current expectations regarding our cardiovascular outcome study, such as anticipated enrollment, the related regulatory process, and potential outcomes; our plans to protect the exclusivity and commercial potential of our product; and our current expectations regarding our co-promotion agreement and our business generally. These statements are based on information available to us today, November 4, 2015. 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 if 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 factor section of our quarterly report on Form 10-Q for the three and nine months ended September 30, 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; Steve Ketchum, our President of R&D; Joe Kennedy, our General Counsel; and Aaron Berg, our Senior Vice President of Marketing and Sales. I'll now turn the call over to John Thero, President and Chief Executive Officer of Amarin.

Good morning. Thank you for joining us today. Many things have being going well for Amarin in recent months. Hopefully that’s clear from the press release we issued this morning. In this conference call, we will discuss Amarin's recent commercial, operational, and financial performance; provide an update on important Company initiatives and legal matters; and then take questions from analysts and investors. Our priorities for 2015 remain unchanged: support/improve patient care with Vascepa, increase revenues, continue to execute on our cardiovascular outcome study REDUCE-IT, and manage our business in an opportunistic and cost-effective manner. Highlights of our Q3 2015 progress include: record prescription and revenue growth from Vascepa in Q3 with net product revenues 51% higher than Q3 2014. REDUCE-IT continuing to progress on schedule with events accumulating at rates consistent with our modeling and enrollment now more than 97% complete against 8,000 patient target. Steve Ketchum, will provide a more detailed update on REDUCE-IT. In August we received a favorable court declaration, allowing Amarin to present healthcare providers truthful, non-misleading information regarding use of Vascepa that outside current FDA approved labeling, including results of the successful ANCHOR study. As expected, we’re finding that physicians were not aware of the ANCHOR study results and that they appreciate learning this data. And multiple presentations of new data further support the potential benefit of the Eicosapentaenoic Acid, EPA, the active ingredient in Vascepa, including presentation at the American Society of Preventive Cardiology Annual Cardiovascular Disease Prevention Conference, and the current Lipid Conference. I’d now like to further describe the continued commercial progress that we made during Q3. In the quarter, normalized prescriptions of Vascepa of 199,000 and 176,000 were reported based upon data from Symphony Health Solutions and IMS Health, respectively. These levels represent increases of approximately 51% and 56%, respectively, over…

Thank you, John. As John mentioned, we’re pleased that Vascepa prescriptions and revenues grew meaningfully in Q3. The prescription numbers from Symphony Health Solutions and IMS Health, as cited by John, represent growth of approximately 13% and 12% respectively compared to the quarter ended June 30, 2015, an increase of approximately 51% and 56% respectively compared to the same quarter in 2014. We experienced growth throughout Q3, starting in July. In August 2015 as previously announced the United States District Court granted Amarin’s request under the First Amendment for preliminary release and confirm that Amarin may engage in truthful and non-misleading speech promoting Vascepa to healthcare professionals beyond the use approved by the FDA, with specific reference to patient studies in Amarin successful ANCHOR study of Vascepa and patients with persistently high triglyceride after statin therapy, and that such speech may not form the basis of a misbranding action under the Federal Food and Drug Cosmetic Act. While not the same as a label change, and specifically not an indication for the use of Vascepa in patients with high triglycerides between 200 and 499 mg/dL, the court declaration allows promotion of the FDA reviewed and agreed upon effects of Vascepa demonstrated in the Phase 3 ANCHOR clinical trial and use of peer-reviewed scientific publications that present the current state of scientific research related to the potential of Vascepa to reduce the risk of cardiovascular disease. We believe that this Federal Court decision and resulting education about the ANCHOR results, will lead to improved patient care as it opens more direct and effective paths to communicate truthful and non-misleading information. With accurate information readily available, healthcare professionals will be better able to decide for themselves how best to choose among available treatment options for their patients. As a result, beginning in…

Thank you, Aaron. REDUCE-IT, the first perspective cardiovascular outcome study to evaluate the effect of a 4-gram dose of a pure-EPA prescription omega-3 in patients who despite statin therapy have elevated triglyceride levels continues on schedule toward anticipated completion in 2017 and publication of results in 2018. To date approximately 7,800 patients have been enrolled representing more than 97% of total targeted patient enrollment. Completion of REDUCE-IT is event driven and depends on attainment of 1,612 cumulative patients with documented primary cardiovascular events. The REDUCE-IT cardiovascular event rate continues to track to our expectations for the protocol pre-specified interim efficacy and safety look by the independent Data Monitoring Committee or DMC, to occur in 2016 upon reaching 60% of the target aggregate number of cardiovascular events. Given the high thresholds of overwhelming efficacy and safety typically required to be achieved prior to an independent DMC recommending an early stop to a large long-term cardiovascular outcomes trial like REDUCE-IT, management continues to believe that it is most likely that the REDUCE-IT study will run to its completion. It is most common for large long-term outcome studies of cardiovascular therapy to not be stopped early. Most cardiovascular outcome studies conducted over the past decade or so have run to completion. These studies included interim looks by independent DMC's for both efficacy and safety, but were not stopped early. If the REDUCE-IT study is not stopped early in 2016, this should not be a surprise to anyone and should in no way be interpreted to suggest that this study is not positioned for success. In the REDUCE-IT study, the independent DMC has met in close session to look at and discuss unblinded safety data on an approximately quarterly basis since study initiation in 2011. And after each such meeting the independent DMC has…

Thank you, Steve. My comments will address our recent financial results. You will find a more detailed discussion of our results in our 10-Q and press release issued earlier today. In Q3 2015, we recognized $21.3 million in net product revenues, representing an increase of 51% as compared to the net product revenues of $14.1 million in Q3 of 2014. As previously described, the timing of shipments to wholesalers vary from period-to-period. However, wholesaler inventory levels largely remain flat during Q3 of both 2015 and 2014. On a year-to-date basis through September 30, 2015, we’ve recognized $54.6 million in net product revenues as compared to $37.7 million in the same period in 2014, an increase of 45%. Note that our year-to-date net product revenues through nine months of 2015 exceeded our full-year net product revenues for 2014. Based on data currently available, we estimate that we will recognize net product revenues of $22.5 million to $24 million in the fourth quarter of 2015 resulting in net product revenues of $77.1 million to $78.6 million for the year ended December 31, 2015. 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. Vascepa revenue growth remains difficult to predict. We are very early in our promotion following the First Amendment court decision and patients who might benefit from Vascepa treatment typically have physician appointments only once a year. We believe that our product revenues will continue to grow, but that such growth will be variable from quarter-to-quarter. We believe that we can grow an attractive and sustainable business based on the current label and promotion of Vascepa, while we looking forward to significantly greater growth following assumed REDUCE-IT study success.…

Thank you, Mike. During Q3, we made important progress as it relates to each of our organizational priorities included accelerated revenue growth, on track execution of REDUCE-IT and continued management of costs resulting in a cash balance of $119 million as of September 30, 2015. We remain focused on these priorities and look forward to the continued implementation of its standard marketing programs in conjunction with the First Amendment opportunity to educate physicians on additional truthful non-misleading information in regards to the potential benefits of Vascepa. While we have briefly commented on our continued progress in China with Eddingpharm. I should add that we continue to explore other strategic opportunities, the timing and structure which are difficult to predict. We are talking with a number of companies in a number of regions of the world. When terms are agreed with one or more of these companies, we’ll of course let you know. In the interim, our focus is on what we more directly control such as REDUCE-IT progress and the U.S. revenue growth. With that, we conclude our prepared comments and we move to open the line to some questions. Operator?

Thank you. At this time, we will be conducting a question-and-answer session. [Operator Instructions] Our first question comes from the line of Shaunak Deepak with Jefferies. Please proceed with your question.

Hi. Thanks for taking my questions. I want to know, I might have missed this in the call, but are you still on track to complete the enrollment of REDUCE-IT by the end of the year? And also, is it possible to give a little bit more granularity on what you might expect to have the interim update in 2016?

Shaunak, thanks for the question, this is John. I’ll take that and Steve Ketchum is here, if I miss up he’ll I’m sure correct me. With respect to the enrollment, we’re about 7,800 of the patients enrolled at this point in time on a -- our target for right around 8,000. Based upon our current trajectory, that enrollment should be completed around the end of the year. It varies from week to week, how many patients are enrolled or is it possible that there could be some spill over into early 2016? Yes, but for the most part we see the enrollment wrapping up here in the relatively near-term. With respect to the timing of the interim look for safety and efficacy in 2016 which I know a number of investors are excited about, because they looked at [indiscernible] data and see that fairly early divide in that study with respect to the trial, but I do remind people as Steve has outlined, it is much more common for trials to run them self to their completion and our guidance is that REDUCE-IT is mostly -- most likely to run itself to completion. The timing of that at this juncture is much more dependant upon how well the data comes together. And by that I mean, and this is not -- this is true for all clinical trials, and pulling that data together and throughout this process of pulling the data together its blinded to us, but we -- in the REDUCE-IT study you’re operating in [indiscernible] 450 sites, until you pull all the data together you don’t really know if you have all the data and you put it into the tables and then you look at it and there’s sometimes chasing of data around not to provide --…

That was helpful. And the other question I had was really on the ANCHOR indication, and I know that it’s too early at this stage to really comment specifically on prescription growth attributable to that indication. But just wondering if you had any early metrics on how physicians or patients might be taking to the potential for using Vascepa in this broader indication?

I think your comment about it being too early is [indiscernible]. At this point in time we’d only have the anecdotes. We have the anecdotes physicians expressing to us that they appreciate the information. We’ve anecdotes of physicians, asking us to come back and talk to them further. We have greater attendance at events where we have physicians speaking to their peers. So we’re seeing interest, but it’s -- we haven’t yet started market research as to message retention or affect, we didn’t start doing the sort of outreach on this until second half of August with our co-promotion folks starting slightly after our own team started and we are as Aaron pointed out taking a very staged approach. We’re taking a piece of information and making sure that docs understand that piece and then we’ll move on to another piece. We are spending a lot of time with physicians to ensure that they understand the information and that we’re presenting it in a factual and balanced approach which takes some time to get it right. I will remind folks that this is not an indication. We think that the information that we are communicating is valuable and powerful and we’re optimistic that is going to have a positive effect in patient treatment as well as on our script levels. But it isn’t quite as direct as marketing a new indication and in particular it doesn’t change anything at the payer level. So you may remember that we have pretty good formulary covered overall, a formulary for over 200 million lives in the U.S. I think the last report was 100 million -- over a 130 million lives on Tier 2 that number has gotten high enough and continues to grow that we haven’t provided quarter-to-quarter updates that I think we’re beyond that at this point in time. Similar to predecessor drugs like Lovaza there has been historically pretty good off label health -- payer coverage of off label use a lot of Lovaza use, that’s been off label less so for Vascepa that may increase here -- its likely to increase here as we move forward. But we need to make sure that physicians are comfortable that their patients will be reimbursed here on off label use and some docs get that right away, some docs need more comfort in it, it does vary from health plan to health plan. So there’s a lot of education going on. We’re encouraged, but it’s early and the short answer is it really is too early to provide any quantification at this stage. We have provided some guidance to what we think that Q4 revenues might look like as Mike had articulated but in the fourth quarter we will -- just gotten to the early stages of communicating essentially our second module of information with the idea of additional information rolling out as we get into 2016 as well. So hopefully those comments are useful.

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

Thanks for taking the questions. But first since you are in continued -- still under discussions with the agency which runs through December 17, maybe for Joe Kennedy. Can you maybe just shape the framework of what the key issues and their arguments are? I’m not looking for what your negotiated position is, but what are the key points that you’re negotiating with the FDA or are you asking them to reinstate the SPA for example something to that degree. Second for Aaron, on the promotion of the product, it seems like you’ve taken a very conservative posture with the sales force in terms of your promotion. When do you incorporate not only ANCHOR but also [indiscernible] into the discussion which I think judge Engelmayer allowed you to be able to use both of those points within discussions with physicians. So those are my two questions. Thanks.

So I will have Joe comment on both of those. Let’s start with the first amendment piece and then we’ll turn things over to Aaron to talk about the promotional piece. Joe?

Right. Thank you, John. So the framework for our approach to -- our goal is going into tell in the negotiations were essentially to take the win that we achieved at some of the declaration point and make that final. That’s our primary goal. That ruling was both broad and specific broad in the sense that it allowed us to seek in a truthful non-misleading way which affected the promotion of Vascepa in the ANCHOR patient population, and specific because it declares the ANCHOR data which -- to which there is no contest from in FDA to be truthful and non-misleading in the context of the statements that were part of the litigation ultimately announced on August 7. So our goal is to take that preliminary ruling and to make it final so we can continue along the path of promotion of Vascepa to the ANCHOR -- for using the ANCHOR patient population. And now with respect to the broader aspect of the ruling, you’re right, with regards to the [indiscernible] promotion that broad aspect to the ruling review has enabling us to speak in a truthful non-misleading way to promote Vascepa in a truthful non-misleading way with respect to data that goes beyond the ANCHOR data, so long as that information is truthful and non-misleading. And so with regard to your specific question as to whether we’re looking to re-implement the FDA or to get a label expansion the short answer to that is no. The FDA has taken a lot of regulatory steps to create a leveled playing field in that regard by taking away indications from pirate product. By taking away indications from [indiscernible] product with regard to an add on to statin which in effect gives us a leg up in our ability to now speak to the use of Vascepa on top of statin’s. So I think that answers your question, if not I’m happy to take a follow-up.

Thanks.

And as part of that, I mean we do talk about this as being a court order of declaration, just for emphasis there was a lot of input from FDA in the process of getting to what is appropriate disclosure of the ANCHOR data? What are appropriate disclosures along with that? Including the FDA asking that we emphasize failed studies of fibrates and niacin, which allows emphasis for and the fact that those drugs are not no long approved on top of statin therapy. And of course FDA is much encouraging us to complete the REDUCE-IT study as the first study in this phase and lots of reasons to be optimistic about the REDUCE-IT study. With that, let me turn things over to Aaron to expand upon our comments about state and thoughtful [ph] launch of the various modules of information under the first amendment.

Thanks, John. And thank you John for the question. So as John just mentioned we continue to take a very staged thoughtful approach to rolling out first amendment. We started with ANCHOR, its just two months in. Sales force is very enthusiastic, but as you know its takes time to get the physicians, once not to mention the multiple times it takes to get them to remember a message to change behavior to impact patient care, to get those patients in that are again a chronic disease and it takes time. With that said, we’re very much looking forward to getting [indiscernible] out there later on here in Q4 we’re prepared to roll that out. In the coming weeks we’ll do that in a very balanced truthful non-misleading way as we’ll continue to do. There’s a lot of good information in [indiscernible] that we’re looking forward to getting that out.

Thank you. Mr. Thero, there are no further questions at this time. I’d like to turn the floor back to you for any final concluding remark.

Thank you everybody for joining us today. I know you need to get back to other things, getting ready for the market to open. We look forward to providing you continued updates on the ongoing progress of Amarin in multiple areas. Thanks again. Bye.

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