Welcome to Amarin Corporation's Conference Call to discuss its Financial and Operating Results for the Fourth Quarter and Full Year of 2017. This conference call is being recorded today, February 27, 2018. I would like to turn the conference call over to Elisabeth Schwartz, Senior Director of Investor Relations of Amarin. Please go ahead.

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 and wholesaler inventories, Vascepa product and licensing revenues, costs and other commercial metrics, gross margin, expenditures and the adequacy of our financial resources, our current expectations regarding our cardiovascular outcome study such as timing of study completion, regulatory review and likelihood of success, our plans and preparation for extended promotion of Vascepa and related market positioning and potential, our plans to purchase additional supply of Vascepa, our goals regarding the timing and scope of international expansion and our current expectations regarding the effects of our co-promotion agreement on our business. These statements are based on information available to us today, February 27, 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, 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 Annual Report on Form 10-K for the year ended December 31, 2017. These documents had 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 key updates discussed on today's call. Finally, an archive of this call will be posted on the Amarin website, again, in the Investor Relations section. I will now turn the call over to John Thero, President and Chief Executive Officer of Amarin.

Good morning, everyone. Thank you for joining us today. Amarin's record 2017 revenues we reported today are at the upper end of the guidance that we last provided and above the revenue level we guided to during 2017. Moreover, we are nearing completion of our potentially landmark cardiovascular outcome trial, REDUCE-IT. We are working hard towards having results to report from this important trial by the end of Q3 2018. And we are preparing for significant commercial expansion after REDUCE-IT results, based upon our anticipation that the REDUCE-IT results will be positive. Mike Kalb will talk further about Amarin 2017 results. I will mention a few highlights. In 2017, we achieved record total revenue of $181.1 million, including $179.8 million in net product revenue from the U.S. sales of Vascepa. This $50.9 million increase in net product revenue over 2016 was supported by corresponding record levels of Vascepa prescriptions. We also improved cash flow such that excluding our disproportionately large commitment to R&D spending, which included over $40 million in REDUCE-IT related payments. And excluding finance related proceeds and payments such as interest and royalties we were cash flow positive in 2017. We provided support for 25 scientific publications. We added HLS Therapeutics as a commercial partner for Canada. Supported our partner for Vascepa in the Middle East, Biologix, and submitting applications seeking Vascepa approval in multiple countries, and supported commencement of a clinical trial for Vascepa in China via partner Eddingpharm. And we are now within 7 months from reporting REDUCE-IT results, having guided for results before the end of Q3. Rather than my focusing on 2017, I will talk to you about our priorities for 2018, the opportunities we are working to address and while we are confident that 2018 will be our best year yet. Our strategic…

Thank you, John. In the United States alone there is more than one death every 38 seconds from cardiovascular disease, a total of nearly 800,000 deaths per year. These numbers are on the rise. Also on the rise is the tremendous cost of treating cardiovascular disease, often while conducting a long clinical study, the patient population being studied becomes less relevant as treatment patterns change and new therapies come on to the market. In the case of REDUCE-IT, the population has actually increased since the study was initiated and the population continues to expand due to multiple factors including increased prevalence of obesity and diabetes. The American Heart Association estimates that the cost of care in the United States alone for cardiovascular disease will exceed $1 trillion a year within two decades. Heart attacks, stroke and other interventional procedures for cardiovascular disease are expensive. This is a healthcare crisis. Cardiovascular disease is the most expensive disease area and the number one cause of death in the United States. It is current responsible for more deaths in the United States than all cancers combined. This crisis affects families, friends and neighbors, and it's not an easy crisis to solve. Since 1987, statin therapy has been successfully advanced to lower bad cholesterol and lowers cardiovascular risk. Over the years, statin therapy has become more potent and other alternatives have been introduced to further lower bad cholesterol. We have learned that lower is better regarding bad cholesterol. However, even with well-controlled bad cholesterol tens of millions of patients remain at high risk for cardiovascular disease. Following the success and improving cardiovascular health via lowering bad cholesterol, focus shifted to raising good cholesterol. Unfortunately, after extensive study raising good cholesterol alone has not shown to have an added clinical benefit. Remaining targets for potentially…

Good morning, everyone. Echoing comments in today's press release, I first want to express my appreciation for the patients in clinical sites involved in the REDUCE-IT cardiovascular outcome study, together with the tireless efforts of Amarin's employees, consultants and contract research staff involved in this potential landmark study. As you likely know, the first patients enrolled in the REDUCE-IT study were enrolled in late 2011, over 6 years ago. This 8,175 patient outcome study is evaluating whether treatment with Vascepa reduces cardiovascular events in patients, who despite stabilized statin therapy have elevated triglyceride levels and other risk factors for cardiovascular disease. If the REDUCE-IT results were successful as Craig described, this positions Vascepa to be able to potentially help tens of millions of at-risk patients. The medical community wants outcomes data. Most patients at high cardiovascular risk are not treated for risks beyond high bad cholesterol and diabetes. Our commercial team is looking forward to moving from the promotion of Vascepa based on biomarker data, which is our current emphasis, to promotion based on demonstration that Vascepa use lowers the incidence of major adverse cardiovascular events. Fortunately, we will have REDUCE-IT result soon. We are approaching the estimated onset of the targeted 1,612 patients with primary Major Adverse Cardiovascular Events or MACE in the study. As a reminder, we don't need exactly 1,612 patients to experience primary MACE in the REDUCE-IT study. Rather, the statistical powering of the study at 90% power to detect a 15% relative risk reduction, was calculated at the start of the study, based on 1,612 patients experiencing a primary MACE. The statistical power of the REDUCE-IT study will be relatively little impacted if at the end of the study we have slightly fewer or slightly greater than 1,612 patients with primary MACE. In fact, given…

Steve, thank you. As mentioned at the start of this call, both our 2017 annual report on Form 10-K and today's press release can be found on our website. They contain discussion of our fourth quarter and full year financial results, including some detail, which go beyond the highlights I will cover in this morning's call. All four quarters of 2017 resulted in strong growth over the corresponding quarters of the prior year. While John mentioned full year net product revenue in 2017 increasing to $179.8 million, I want to add that our fourth quarter 2017 net product revenue will also set a record quarterly high for us by increasing to $53.5 million. Our 2017 net product revenue growth reflects increased Vascepa prescriptions volumes, particularly from the physicians called upon by our sales team. Net pricing in 2017 was relatively flat and the impact of shifts in wholesaler inventory levels was not significant with wholesalers ending 2017 with Vascepa inventory levels that were consistent with industry norms. With respect to revenue guidance for 2018, we continue to believe that the measurement of Vascepa growth compared to corresponding periods of the prior year. It's a better measure of our progress than evaluating consecutive quarter growth. We emphasize the value of comparisons year-over-year quarters, because in the United States we continue to experience and anticipate seasonal effects such as typical slower prescription levels in Q1 of each year as patients are slow to fill prescriptions when they encounter large annual deductible amounts under their medical insurance plans. Guidance for 2018 is further complicated by our inability to accurately predict to relative risk reduction demonstrated by Vascepa and the REDUCE-IT trial or the precise timing of the results of the REDUCE-IT trial. Accordingly, our guidance for 2018 is based on our current promotion…

Thank you, Mike. I want to take this opportunity to thank our shareholders for your support and our employees for their great contributions. We have a considerable amount of work to do before and after the REDUCE-IT read out and I know the team is up to the challenge. Overall, 2017 was a terrific year. We have every expectation that 2018 will be an even better year. We look forward to updating you along the way. With that, we conclude our prepared comments and would like to open the line to some questions. Operator?

Thank you, sir. At this time, we'll be conducting a question-and-answer session. [Operator Instructions] Our first question today comes from Louise Chen of Cantor Fitzgerald. Please go ahead.

Hi, this is Jennifer Kim on for Louise. Thanks for taking my question. I have a few here. My first one is what ranges do you have in mind for the 2018 revenue forecast in the different possible REDUCE-IT scenarios, so if it hits the primary endpoint, if it doesn't hit but it hits some secondary endpoints or if it doesn't hit any secondary endpoints? And then second, how quickly can you ramp up after REDUCE-IT results and how fast do you think uptake can be? Thanks.

Jennifer, good morning. John. Thanks for the questions. With regard to the first question, we're preparing for success and this maybe gets a little bit into your third question, it's what does can success constitute, because assume when we hit the primary end point with just little significance, do we hit that with 15% relative risk reduction as the trial is designed around? Do we hit it with a lower number, which given the [power in those] [ph] study, which is possible or do we hit it with a higher number which is - will have - equally possible. This is the first study ever in this population. I think there is considerable data suggesting support for a 15% relative risk reduction. Could argue there is considerable support greater than the 15% relative risk reduction. But we really don't know, because this is the first study ever of any therapy in the combination. We're very pleased that the unique profile of Vascepa positions us for success here. The rate at which we think that our revenues will grow will be heavily impacted by that relative risk reduction level. It will also be heavily impacted by our level of promotion. And our level of promotion will be different if we have a 25% relative risk reduction versus a 15% relative risk reduction versus, say, a 10% relative risk reduction. We think we grow substantially under all of those scenarios, but trying to predict the magnitude of it without knowing the details of the results within, that's - I think the top-line results really are what's key. But looking at some of the underlying results, how do we deal within the diabetic subgroups and some of the other subgroups could have importance. So we at this point in time are not giving…

No, definitely. Thank you.

Our next question comes from Joel Beatty of Citi. Please go ahead.

Hi, good morning and congratulations on the revenue growth. The first question is with regards to the marketing program. If we do see the results are successful, do you anticipate that marketing messages could incorporate those results right away and physicians could prescribe it in the REDUCE-IT population right away? Or should we expect it to take some time to wait for, say, a label change or prepare guidelines to change before the revenue could ramp up with regards to the REDUCE-IT results?

Joel, good morning. Thanks for the question. So as part of the communication of the results, I mean, if they're as robust as we anticipate, we think that regardless of what are field reports are saying that, amongst key opinion leaders and physicians and hopefully the general public, this is a huge advance in preventative care for patients at risk for cardiovascular event. So we hope that that news will spread independent to what we're doing. We'll certainly through public relations efforts, try to make sure that people aren't paying attention - pay attention. As part of our current promotion of Vascepa, there are certain required disclosures that we have about conducting a cardiovascular outcome study. By the nature of those disclosures to the extent that an outcome study has been conducted, we will have to be doing some updating of our messaging. The specifics of how we will update our messaging are still to be worked out. Certainly, those updates would include caveats that results haven't yet been reviewed by the FDA. But as part of our current messaging there is a statement that it hasn't been studied, and we said it has been studied. We will have to be a sort of de facto providing some update. Again, the degree to which required an update depends upon the results and we'll have to see those results before we can make that final determination as to the extent to which we provide those updates. And do we do that right way, do we wait until after it's published in the fourth quarter, do we wait until it's after sNDA is submitted, we'll have to - got to see. Certainly, after the label is expanded there would be broad expansion. And during the process of seeking label expansion, we will be interacting with societies that provide guidelines to ensure that they are aware of these results. Many of the scientific members involved with setting guidelines in some of those societies, are certainly intimate with what we're doing in the REDUCE-IT study and very interested in the results of the REDUCE-IT study. So that the pace at which they will move will have to be seen as well. But we will be interacting early and often with those groups.

Okay. Thanks for that perspective and then one follow-up question. It is a - typically, we see a little bit of a decrease early in the year for Vascepa sales. And I think you mentioned that a little bit in your prepared remarks. But could you talk about the dynamics, that you even seeing they go into that, and if it's comparable to what you've seen in previous years and what you might expect for the rebound to look like? Thanks.

Sure. So historically, and this is part - as you referenced, Joel, this is part of our guidance. Historically, we have seen seasonal differences in our - our trends in our product. In particular, in Q1, we found the results to be relatively soft. We reported on months that it'd be - looked at trends particularly soften sort of the January, February timeframe. As it relates to really beginning of the year, insurance for patients, the patients that are on Vascepa tend to be very sick patients. They are not just patients treated with Vascepa. They're often patients who are hypertensive, they may be diabetic, they've got elevated cholesterol, and many of them had previous cardiovascular events. There are a lot of different therapies and if they have - it seems increasingly popular under insurance plans beginning of the year deductibles of $1,000, $2,000, $3,000. And they go into fill their five or six prescriptions. What they may be used to be coming back with this five or six prescriptions each filled for $10 to $15 each. And all of a sudden they're coming back for the bill for $1,000 or more. They end up picking and choosing, what prescriptions they bill at that point in time. And something like a pain medication they're going to fill, something for asymptomatic conditions, if they are financially limited they may choose not to fill. So Vascepa and this is true for many drugs, particularly those for asymptomatic conditions doesn't mean the drugs are important, just that patients have to make consumer choices on where they're spending their money. They tend to not fill those prescriptions. We've seen this ever year for Vascepa, and then we see rebounds in scripts in March and particularly in Q2. So our guidance that we have provided…

Okay. Thank you.

Our next question is from Matthew Andrews of Jefferies. Please go ahead.

Thank you for taking the question. This is Roger Song for Matt. So congratulations on the record revenue year. So we have two questions, the first one I leave it to the REDUCE-IT. So I know as Steve provided a pretty detailed plan for the analysis after the final revisits from the study. So can you just give us some more color about the timeline regarding each step after the final visit from the study?

Roger, good morning. Obviously, REDUCE-IT is a big area of focus. I'm sitting here next to Steve Ketchum, and he's just coming from Investigator Meetings with clinical sites that are very enthused to see with the results of the study are. But also clinical sites that recognized that there is a lot of work to be done here with bringing all the remaining living patients back in. A challenge, and this is not unique to this study, a challenge for any study, where you've got many patients at many clinical sites just to get all that data. And you were talking about over 33,000 patient years of study. That's a lot of data to be collected. We intentionally did some interim reviews to try to get data rolled up early. But when you get to the end of the study, you're still pooling in those final reports on patients. And those final reports including blood work, et cetera, it is very important data. And it is data that - and until you have it all into the database, you're not exactly sure what you're missing. I mean, we have lots of different reports and analysis that tries to identify pieces that are missing and give us sort of early reads on what you're chasing. But until the data is starting to roll up, you don't know if you got it all or whether there is inconsistencies that need to be cleaned, and with clean meeting - followed up to confirm that they were accurate, whether to see some of the data that are missing. So we're providing a lot of time to ourselves and through our very experienced CRO and providing instructions to the clinical sites on how to do this. But a key variable or the key variable relative…

Sure. That's very helpful. So my second question is, historically you have taken about annual price increase approximately 6%. So if reduces positive how much larger kind of price increase? If any, do you believe you can take without push back from payers?

So the payer question actually is a good one in the context of - we've seen other drugs that there haven't been major - hasn't been really a major advance in cardiovascular preventative care since statin therapy. But there have been advances such as PCSK9s, for example. And we think that lowers better on the LDL side. But we've also seen that from multiple studies of LDL cholesterol lowering that you can get it really lowering and still have significant residual risk, which is while we're doing we're trying to do. But unlike, say, PCSK9 that introduced to the market, A, with a high price and, B, without managed care coverage, when we have our results I think we are going to benefit from the fact that we've already have brought managed care coverage. We believe first and foremost that our opportunity is a volume opportunity. There are tens of millions of patients who potentially could be addressed by Vascepa if we're successful. And our - we're now trying to replace statin therapies for we think that statin therapies, Lipitor grew to, what, $15 billion, $16 billion, because, A, it worked and, B, it was affordable. And our pricing today is not too dissimilar to where branded statins were, or it's slightly below that. You're right; we have taken annual price increases. Those price increases have generally then given back through rebates and wholesaler fee, such that our net pricing has been generally flat now for the last couple of years. Our growth has been volume driven. And we believe that our growth after a REDUCE-IT success will be volume driven. Will we look at price? Sure, we'll look at price. But this is really a volume story. And I think as we sort of thought of it as a volume story. And at this point in time without having seen the results, our plan is for this to continue to be a volume story and to the extent we do anything on price, we'll evaluate at the time. But that's not going to be the primary driver of our growth.

Got it, very helpful. Thanks you. That's it.

Thanks, Roger.

There are no additional questions at this time. I'd like to turn the call back over to John Thero for closing remarks.

Folks, thanks again. Less than 7 months to REDUCE-IT results. People here are working very hard towards that. In parallel, we believe that we're going to continue to grow our commercial business. Exciting times here. We appreciate your interest and support. And we look forward to providing you updates as we move forward. Have a great day.

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