Welcome to Amarin Corporation’s conference call to discuss its financial and operating results for the first quarter of 2019. This conference call is being recorded today, May 1, 2019. I would like to turn the conference over to Elisabeth Schwartz, Senior Director of Investor Relations of Amarin. Please go ahead.

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 shipments and prescriptions, Vascepa product and licensing revenues, costs and other commercial metrics, gross margin, expenditures and the adequacy of our financial resources; our current expectations for scientific presentations, publications, regulatory reviews and related timing thereof; our expectations that REDUCE-IT results could lead to a new treatment paradigm in the patient population studied; our plans and preparation for extended promotion of Vascepa and related market positioning and potential; our plans to purchase additional supply of Vascepa, and our goals regarding the timing and scope of international expansion; and our current plans for sales force and other commercial expansion. These statements are based on information available to us today, May 1, 2019. We may not actually achieve our goals, carry out our plans or intentions or meet the expectations disclosed in our forward-looking statements. Actual results or events could differ materially, so you should not place undue reliance on these statements. We assume no obligation to update these statements as circumstances change. Our forward-looking statements do not reflect the potential impact of significant transactions we may enter into such as mergers, acquisitions, dispositions, joint ventures or any material agreements that we may enter into, amend or terminate For additional information concerning the factors that could cause actual results to differ materially, please see the Forward-looking Statements section in today’s press release and the Risk Factors section of our quarterly report on Form 10-Q for the year ended March 31, 2019. These documents have been filed with the SEC and are available through the Investor Relations section of our website at amarincorp.com. We encourage everyone to read these documents. This call is intended for investors of 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 subcategory, Events and Presentations, summarize some of the key updates discussed on today’s call. Finally, an archive of this call will be posted on the Amarin website also in the Investor Relations section. I’ll now turn the call over to John Thero, President and Chief Executive Officer of Amarin.

Good morning, everyone. Thank you for joining us today. I look forward to discussing Amarin’s progress and outlook with you. Q1 was a very good quarter for Amarin. We made important progress in numerous areas and we are confident that we will continue to execute on the strategy, plan and goals we described in our last investor conference call. Our aim is not repeat all such matters in this call, but to focus on highlight and other updates. In this discussion please note that despite the progress we made in Q1, we are still very early in the second of the four phases of commercialization that we described in our last investor conference call. In particular, we do not yet have an expanded label for Vascepa. As previously described, a broader label will facilitate broader product promotion. As listed in today’s press release, Amarin highlights from first quarter of 2019 included a 67% increase in total net revenue. Such revenue was $73.3 million in Q1 2019, compared to $43.9 million in the same period of last year. Our submission on March 28 of a supplemental new drug application or sNDA to the U.S. Food and Drug Administration seeking an expanded label for Vascepa based upon the positive results of the landmark, REDUCE-IT cardiovascular outcome study. Scientific presentation and simultaneous publication of total events analysis from the REDUCE-IT study which showed that the Vascepa provided a statistically significant 30% risk reduction in total cardiovascular events, compared to placebo in the statin-treated patient population studied in REDUCE-IT, demonstrating approximately one fewer major adverse cardiovascular events per six patients treated with Vascepa over a five-year period. Medical treatment guidelines updated by the American Diabetes Association, based upon the results of the REDUCE-IT study, recommending icosapent ethyl be considered to reduce cardiovascular risk in…

Thanks, John. As mentioned at the start of this call both our Form 10-Q and today’s press release can be found on our website. They contain discussion of our first quarter financial results including some details which go beyond the highlights we will cover in this morning’s call. First quarter of 2019 showed significant gains and sales over the first quarter of 2018. Its volume driven gains occurred despite recurring seasonal headwinds caused by beginning of the year insurance deductibles as experienced by many people under their insurance coverage. Such deductibles which are not unique to Vascepa often cause patients not to fill all prescriptions near the beginning of each year, because they can’t afford to pay the full insurance deductible all at once and as a result they forego filling certain prescriptions. Such headwinds appeared to have persisted in 2019. However, the refill rate was approximately 3% to 5% higher in Q1 2019 than in Q1 2018. Perhaps, motivated by the robustness of the REDUCE-IT clinical results. Moreover, new prescriptions or NRxs of Vascepa in Q1 2019 increased approximately 80% compared to Q1 2018, based on data provided by Symphony Health. Such increase in new prescriptions of Vascepa powers the presentation and publication of results from the REDUCE-IT cardiovascular outcome study and following expansion of Amarin sales team, net of not extending the relationship with our prior call promotion partner. Amarin’s total revenue for the first quarter of 2019 was $73.3 million, compared to total revenue for the first quarter of 2018 of $43.9 million. Product revenue represents the vast majority of Amarin’s total revenue. In the first quarter of 2019, net product revenue was $72.7 million, representing an increase of 66% over the same quarter of 2018. The core driver of this period-over-period increase was volume growth in…

Thank you, Mike. Amarin’s General Meeting of shareholders is scheduled for May 20th in Dublin. As reflected in our recently filed proxy statement, we anticipate that this will be a relatively straightforward meeting. The proposals set forth by our Board of Directors are for ordinary or recurring matters. Each such resolution is intended to support Amarin’s growth going forward. We hope that all of our investors support us in such matters and I thank you in advance for your support. Before beginning the Q&A portion of this call, let me respond to a line of questioning that we hear periodically regarding our ongoing ANDA litigation. Our patents expire in 2030, the public record for the ANDA litigation is available for all to view and many have. As a reminder, there are two ANDA filers that remain in the litigation from the original four. Apotex determined to not litigate in the case early on in the proceeding. Rather than continue to litigate, Teva settled with us, to enter in August of 2029. There is no IPR proceeding, that is inter parties review in that case. The statutory one year window for IPRs from the end of filers on the relevant patent has expired. While court schedules can change, current timing suggest that this matter, assuming it is not settled, would go to trial in early 2020. We continue to defend our patents vigorously. We don’t plan to comment further regarding ongoing litigation beyond the above. With that we conclude our prepared comments, and we’d like to open the line to some questions. Operator?

Thank you. At this time we’ll be conducting a question-and-answer session. [Operator Instructions] Our first question comes from the line of Louise Chen with Cantor Fitzgerald. Please proceed with your question.

Hi. Thanks for taking my questions, and congratulations on a strong quarter. I had a few questions here. So with respect to your prior guidance of $350 million before the year, I didn’t hear that you had updated that. Just curious if that is the guidance that we should still adhere to, as we model for the rest of the year going forward? So any color on that would be helpful. Secondly, with respect to Vascepa due, are you looking to file any additional patents given the good results of the REDUCE-IT study? And then third question I had, I get this question a lot with on how proprietary your supply chain is? And if that’s a competitive advantage for you? Thank you.

Louise, it’s John. Good morning. Thanks for the nice comments. With respect to guidance, we’re still very early here in the launch. We talked about our sales reps being out to most to these targets for in that two to three times rate range. We’re pleased that our growth in the first quarter exceeded 50% last year’s first quarter was the lowest of that quarter for the year. The hurdles get higher as we go forward. We’ve not changed our revenue guidance for the year. That guidance does assume that as we expect a standard 10 month review clock for our sNDA filings, were that to change, I’m not suggesting it would, but were that to change, with the previous year’s guidance at that point. But at this point we are not changed. We have not changed the guidance for revenues for the year. With respect to supply, the manufacture of Vascepa is very difficult. The – we’ve scoured the world trying to find the best suppliers. We work with companies. It’s numbers of them have failed on early attempts to manufacture Vascepa. We know that when there was a generic elevator that came in the market, there were manufacturing issues at the beginning. So we are – we do sense that and being able to produce this difficult to manufacture product and to be to produce it, yield cost effectively. I mean, it is important. And we are using the capacity of our suppliers pretty completely at this point in time. We’ve not updated the – our guidance relative to our overall capacity. But we are working toward what could be a doubling or tripling of that potential overall capacity. The earliest plans therefore, being more definitively in place before the end of this year. So I do think it is a competitive advantage and those suppliers are beholden to us. With respect to patents, we have submitted a number of patents off of the REDUCE-IT results. This is the first ever study in an important population. We do believe that there were surprising and unexpected findings on which we’ve had file spend. We have had some patents granted to us based upon to outcomes for the treatment of this patient population. But there are additional patents on file and our experienced IP team continues to scour the data and look for further patents. That’s actually quite a few of them. So I’m not going to go through them all and particularly not the ones that haven’t granted, but so yes, lots of patents.

Okay. Can I just have a quick follow-up? Thank you for that, on that on the guidance question. So I guess to me it sounds like you’re being a little bit conservative, given where the script trends are headed and the fact that there were some offsets even in the good script trend in the first quarter. So any color from that front? If you don’t want to comment, it’s fine, but I’m just asking is, it just seems like the $350 million probably is going to come in low relative to where the scripts are headed? Thank you.

Yes. Growing any business when you don’t yet have label expansion and we’re restricted with regard to what we’re talking about. Growing something by greater than 50%, we think is a sizable number. I like your optimism, but we’re really early and still in what we’re doing and like a little more of a runway here before we would reach a similar degree of optimism. So I know our sales force is out there, they’re getting terrific feedback from customers, but these docs haven’t had a practice changing therapy in a long time, and while they appreciate the data for REDUCE-IT, how quickly they implement this for their patients and how broadly they implement this for their patients, still a lot of unknowns out there. And if we compare our growth after outcomes data to the growth that we’ve seen. For example, some of the diabetes medicines and PCSK9, et cetera, we’re sort of out and ahead of the pack on that. So I don’t want to get too far out of our skis, particularly in that we don’t yet have a label. So I hope you’re right, but it’s still early.

Okay. Thank you.

Thank you. Our next question comes from the line of Joel Beatty with Citi. Please proceed with your question.

Hi. Good morning. Thanks for taking the questions. First question is on the script count. Could you comment on how accurate you believe that the Q1 script counts are? And I’ve realized that you believe the growth rate was understated, but you’re curious on the actual level? And then second question is on net pricing, could you comment on how that change, if any in Q1 compared to Q4 of last year?

So, on the script count, as Mike has already provided a lot of comments there. I’ll jump in and I’ll let me talk about net price. I don’t think the scripts are even spot on. The fact that the two leading providers of script data don’t agree with each other ever, sort of suggests that they’re not spot on. On an annual basis, in terms of percentage change, they’ve been pretty good on a quarterly basis. They’ve been off almost every quarter and sometimes they overshoot, sometimes they undershoot. And that over, under-shooting tends to be exacerbated during periods of inflection. And we think that they were under in the fourth quarter, we think they are under in this first quarter based upon the – what we’ve seen from a shipment’s perspective. They use sampling techniques. This is information. We don’t have specific information on what the real prescription levels are. So we look to their data with interest as well. It’s the best of what exists, but I think it should all be viewed with sort of that perspective in mind, that it is a combination of some real data and some sampling. And at least, I think in the first quarter we grew up a bit differently than what they sort of indicated. So absolute numbers, I don’t look at them all that reliably, but on a percentage basis over a longer period time, I think, they’ve become more reliable. And as Mike commented, particularly on Symphony Health, they have disclosed that they had some data reporting issues in the first quarter, or not sure that through all of that. At this point in time, I’m sure they’ve done their best in terms of making estimates based upon the information they have, but even they’re commenting of their data wasn’t up to their usual standards for the first quarter. With respect to net price, Mike, do you want to jump in?

Sure. Thank you, John. And thanks for the question Joel. Net selling price, as we mentioned in this quarter has decreased slightly due to an increased portion of the Vascepa prescriptions in 2019, coming from a Medicare insurance coverage. If we look at Q1 2019 compared to full year 2018, were fairly flat, down compared to Q1 2018 as we mentioned. That’s kind of what we’ve said repeatedly, quarter-on-quarter, year-on-year as compared to Q4 2018, which I think was the question, its roughly flat, down just a drop.

Got it. Thanks. Maybe one other question on the payer approval rates. I wonder if they’ve changed at all in Q1 due to either seasonal aspects or related to script growth?

Joel, some of that data, we don’t get fully, is a little bit delayed, but based upon the data we’ve seen, we didn’t see any particular change in terms of the payer approval rate. As we’ve talked about, I think that there are beginning of the year insurance deductibles which are not Vascepa specific, they’re patient specific that do have some influence over the rate at which patients fill prescriptions. And we did see the rate at which patients fill prescriptions in the first quarter of this year be a little bit higher than what we saw in the first quarter of last year. But on the payer side, I didn’t see any real change in the approval rates, nor what I’ve expected any major change in that regard.

Great. Thanks and congrats on the revenue growth.

Thank you.

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

Hey, thanks. Couple of questions as well. I know that a lot of people asking questions around the scripts. I mean, I guess I would just like to confirm and clarify that if you reported $77 million in the fourth quarter and $73 million in the first quarter, that the delta there would have been inventory and that if scripts were up so much in Q1, 15%, or 16% or so, I guess your true demand sales in the first quarter would have been high 80s or 80s. Maybe you could clarify that for us. You same scripts are actually underrepresented so just trying to triangulate that. And the second question was on Europe. I mean, I guess, how are you thinking about the different push/pull factors as you think about that through the course of the year? And how important are just keeping wholly-owned rights for this asset for as long as possible? Thanks so much.

Mike I appreciate the comments. And just an overall comment to operator and others are in the queue, I guess I probably talked a bit long here in our introductory comments, and we promised people we’d try to keep this to an hour, so I apologize that we probably won’t get questions from other people, but do follow-up. We do look forward of following up with people separately. With regarding prescriptions, we continue to advise that the best way to look at our business really is year-over-year as opposed to on a consecutive quarter basis due to the seasonal effects. That being said, we have experienced some channel inventory fluctuations, all of which have been in the sort of ordinary course, and the people aren’t as familiar with this wholesalers ordering in chunks. And they’ve changed the ordering pattern sometimes based upon where holidays fall, based upon where the end of a quarter falls, based upon where weakest things are delivered in or not delivered in, and our inventories have sort of been in the, what we’ve consider the normal range, but that tends to vary up and down. If you were to, and I think this is what you’re trying to get to, if you were to adjust out for estimates of channel inventory in the fourth quarter and the first quarter, you could argue that the first quarter was actually slightly up versus the fourth quarter. But I don’t think – I appreciate your curiosity on that topic, but I really do think that because of the seasonal effect, that it’s a stronger way to look at, or a more valid way to look at it on a year-over-year as opposed to consecutive quarter basis. But I hope those comments are helpful on that. With respect to the…

Hopefully those comments were helpful. It is 8:30 East Coast. I appreciate all the interest here. We look forward to continuing to provide updates on our progress. Again I think Q1 was a good quarter, but we’re just getting started, and we’ve made progress in a lot of areas and we look forward to much more as the year goes on. So we thank you very much.

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