Welcome to Amarin Corporation’s Conference Call to discuss its financial and operating results for the Fourth Quarter and Full Year of 2019. This conference call is being recorded today, February 25, 2020. I would now turn the conference call over to Elisabeth Schwartz, Senior Director of Investor Relations of Amarin.

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 receipt for prescription, receipt of product and licensing revenues, cost and other commercial metrics, gross margin expenditures, such as for the purchase of additional supply of VASCEPA and the adequacy of our financial resources, our current expectations for additional scientific presentations, publications, medical guidelines and regulatory reviews outside the United States and related timing thereof, our plan and preparation for expanded promotion of VASCEPA and related market positioning potential, including the potential for further product development, our goals regarding the timing, scope and success with international expansion, our current plans for sales force and other commercial expansion in the United States and our current expectations regarding the outcome of litigation pertaining to VASCEPA exclusivity in United States. These statements are based on information available to us today, February 25, 2020. We may not actually achieve our goals, carryout our plans or attentions 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 when determining. For additional information concerning our factors that could cause actual results to differ materially, please use our forward looking statement section in today's press release and the Risk Factor section of our annual report on form 10-K year ended December 31, 2019. These documents have been filed with the SEC and are available through the Investor Relations section of our Web site at amarincorp.com. We encourage everyone to read these documents. This call is intended for investors and Amarin is not intended to promote the use of VASCEPA outside its approved indication. Please note that, we are also providing slides to accompany today's call. These slides, which can be found at our Web site amarin.com in the Investor Relations section under the category 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 Web site, also in the Investor Relations section. I'll now turn the call over to John Thero, President and Chief Executive Officer of Amarin.

Hello, everybody. Thanks for joining us today. During this call, we will recap our 2019 results, which were quite positive and provide some insights into our 2020 priorities and early 2020 progress. After our prepared comments, we will respond to questions. Some of you sent questions in advance. We attempted to address many of those questions in our prepared comments. It is exciting and busy time for Amarin. We are enthusiastic and encouraged by the progress we're making and by the feedback we are hearing from healthcare professionals regarding the VASCEPA and its now expanded role in improving patient care. Amarin's results in 2019 position us well for the future. In 2019, we received FDA approval of VASCEPA for broad and new cardiovascular risk reduction indication, pursuant to the completion of our seven year REDUCE-IT outcome study and following a unanimous 16-0 AdCom vote. The unanimous AdCom votes are uncommon and this vote reflects the robust and consistent clinical results demonstrated by VASCEPA with clinical benefits, which clearly outweighed risks for patients needing this paradigm shifting therapy. We realized an 87% increase in revenue over 2018, predominantly through increased volume of VASCEPA sold in United States, reflecting growth in normalized prescriptions of VASCEPA. Typically, an 87% increase in revenues would be the first on our list of achievements. For 2019, this growth is eclipsed by the enormity of the importance of patient care and to Amarin of the FDA’s approval of the expanded indication for VASCEPA. In addition, we contributed to the issuance of 57 scientific publications and presentations; supported our Canadian partner’s approval to market VASCEPA in Canada; filed for approval to market VASCEPA in Europe and had that filing accepted for review as a centralized filing by the European Medicines Agency; hired and on-boarded hundreds of sales representatives…

Thanks John. As mentioned at the start of this call, both our 2019 annual report on Form 10-K and today's press release, can be found on our Website. They contain discussion about fourth quarter and full year financial results, including various details, which go beyond the highlights I will cover in today's call. Because our actual results for 2019 and financial guidance for 2020 are consistent with what we communicated at the start of 2020, I intend to be brief in my financial review. John reported that our 2019 full year normalized scripts increased 78%, while our revenue increased 87%. Both percentage increases represent solid growth and reflect strong execution by our commercial organization. Differences are not uncommon between script numbers, which are estimated by third parties and product shipments for which we have direct records and upon which we recognize revenue. We have on various prior occasions provided explanations for such differences. I will summarize such explanations here as the question is likely to otherwise be raised. As a reminder, Amarin recognizes product revenue when its customers, consisting mostly of independent commercial distributors take title to the product they order. This is typical practice for pharmaceutical companies. Amarin revenue is not recognized when individual patients fill prescriptions. One factor which in some reporting periods explain such differences as changes and channel inventory levels. That explanation was not a major factor in our 2019 results as channel inventory levels have stayed within normal and consistent industry ranges. Another explanation for the recurrent discrepancies between script and revenue numbers is limitations of the data available to the third party prescription reporting services. Because of practical limitations, they rely on incomplete prescription information for their algorithm calculations. As in the past, such algorithms seem to be delayed in reflecting inflections upward or…

Thank you, Mike. I thank our shareholders for your support. I also thank our employees and many collaborators for your tremendous contributions. We have a very capable team at Amarin and we are confident in our ability to continue to execute effectively. We are motivated to do so for many reasons, not the least of which that we are passionate about improving patient care and because we too are Amarin shareholders. Amarin will be participating in two upcoming investor conferences. The first is tomorrow, the Leerink conference in New York City. The second is the Cowen Conference in Boston on March the 2nd. We look forward to seeing some of you at those conferences. With that, we conclude our prepared remarks and would like to open the line to some questions.

Thank you. At this time, we'll be conducting a question-and-answer session [Operator instructions] Thank you. And our first question today is from the line of Michael Yee with Jefferies. Please proceed with your question.

Two questions and neither of them are about the patent, I’ll let someone else ask about that. In the U. S., could you provide some more color around thoughts around Q1 seasonality? In other words, scripts do appear to be growing, but you made a comment about how maybe third party data may not be so accurate if something is changing in algorithm or some label change or something like that. So maybe talk about that and whether it's possible that sales in Q1 could be flat or sequentially down just what would you expect versus what scripts are growing. And then in Europe, my question is around your comments about the potential for approval at the end of the year. Do you expect to hire a sales force there? Is that in the guidance and expense guidance? Or when would you think about that, because that can take some time? And I thought you made a comment about how the time could be longer than 10 years out there. So just maybe talk about. Thank you.

With regard to the U. S. seasonality, this is not new to us and nor is it unique to us. We've seen Q1 every year on a year-over-year basis have good growth, but on a consecutive quarter basis, in this case compared to Q4 of the prior year, often drop off. That included even last year where we were coming off of a result presented at AAJ and really very terrific results. So we saw last year even because of this, we saw close to 40% of patients who are on the drug, not fill prescriptions in the first quarter of last year. Now a lot of those patients end up circling back later but these patients are sick patients. They're often on five, six, seven, eight therapies and if they've got, for example, $5,000 copay and they go in expecting on a monthly basis an aggregate for those five, six, seven drugs to copay of say $200 to $300 and they get told that it's $3,000, they start making decisions. And one of those decisions can be, I've got to pay for my pain medicine but I curtail my spending elsewhere. So we anticipate that we will, despite the very positive result with VASCEPA and the benefit that it provides for patients be subject in Q1 of this year to saw the spending discretion of patients. Now we also expect that to be offset, we've seen all the signs of that this year as we did last year, offset by new patient prescriptions as to the degree to which the new patient prescriptions will offset the decline in refills in the first quarter that remains to be seen. I think we have very good NRx numbers in the first quarter of last year, we're hoping for the same this…

Our next question is from the line of Yasmeen Rahimi with Roth Capital. Please proceed with your question.

John, thank you for sharing with us that eight abstracts have been accepted at upcoming ACC. I would love to hear your thoughts to the extent maybe you can give us color on the late breaker, which is supposed to show us EPA levels as produced in IP and related to cardiovascular outcome. Can you maybe tell us a little bit how that data set is different from what we have seen it last EHA to the extent that you can? And then the second question is in regards to the failure of STRENGTH as you've been discussing where physicians as well as some of the top experts in the space and third party providers. Has the failure of STRENGTH created sort of even a stronger buzz for VASCEPA? Would love to hear sort of the sentiment that you're getting on the hills with that? Thank you so much for taking my questions.

With regard to your first question in ACC, we are very pleased by the attention that is coming our way for publication and research. You may remember particularly those who have followed Amarin for a while, we had publications coming out of the successful Phase 3 ANCHOR and MARINE studies for five, six years after those studies were completed, the more you dug, the data is kept getting better, and better and better. And I suspect here with REDUCE-IT, we’ll be having streams of publications that will be lasting years as well. So we are looking forward to the multiple presentations that are coming up here in March at ACC and as commented on the call, we will be having a webcast of summaries of those presentations by some of the authors of the various items. With respect to the late breaker, the ACC is very adamant that we not describe details of it. If we did describe details of it, it jeopardizes our ability to make the presentation at ACC. And we think that having information disseminated in a peer review setting and in front of various cardiologists and other leading physicians is valuable to the brand and its opportunity to help billions of patients. So I can't comment in details there other than to say that we are looking forward to it and we'll provide update as that becomes public. With regard to the failure of the STRENGTH study, it's probably in a minor way helped us. But we had been expecting all along that our results would be differentiated from what they had. I think to the extent that it helps us, it probably helps us in the two following ways. Our managed care coverage is already good. We have managed care coverage on commercial plans that…

Thank you. Our next question is from the line of Louise Chen with Cantor Fitzgerald. Please proceed with your question.

So my first question for you is with respect to your sales guidance. Do you include anything for the EU in that guidance? And then secondly, you had mentioned some additional improvements in coverage in the coming months. Can you provide any more color on how that will translate into sales or what you expect there? And then the last question I have for you is with respect to who is prescribing VASCEPA. Is it mostly specialist and then is that mix going to change over time to more primary care as you get out with this new label and your promotion? Any thoughts there will be very helpful? Thank you.

With regard to our guidance, no there's not anything in there for the EU if we were to get approved and launched this year, and add revenues for the EU that would be incremental. With regard to coverage improvements, I just mentioned I think our real offside here is through education, awareness and usage. We are anticipating improvements in managed care coverage to the extent that that improvement were to happen faster than what we're expecting, that could be upside but we have baked into our expectations that we will get continued improvement in guidance, some of which we saw at the beginning of the year, some of which we've referenced has happened here earlier and some of which we have seen occurring here in the first quarter. With respect to who's writing the drug today and where that might come from in the future, I’m accompanied here by various of our team, and let me turn that one over to Aaron Berg, our Chief Commercial Office. Aaron?

Right now, about 80% of the prescriptions come from PCPs that includes NPs, PAs. Cardiologists are about 15% and growing rapidly endocronologists are another 5%.

The fastest growing group amongst those on a percentage basis is the cardiologist, followed by the endocrinologist and the specialists are growing faster, but it just many, many, many more primary care physician. So as an aggregate volume, the primary care is making up the big biggest increase and that's consistent with what Aaron and his team has expected. And on the growth, I mean last year in terms of overall growth, we had about 87% increase in revenues, we had about 50% increase in prescribers. So that shows that adjusting prescribers are prescribing more but we also have more prescribers coming on and all those prescribers and certainly included cardiologists and endocrinologists, but the biggest piece of that was in primary care.

Thank you. Our next question is from the line of Jessica Fye with JP Morgan. Please proceed with your question.

This is Yuko on the call for Jessica. Thank you for taking our questions. I know its early days. But how are the new reps tracking from a productivity standpoint? I think with the prior sales force expansion we talked about how they hit and exceeded target productivity metrics ahead of schedule. Thank you.

A good question, certainly something we're monitoring. It really is too early. Some of them aren't even in the field yet, some of them have just gotten into the field. I think last year what we expressed was that when we got to about mid-year, these were comments that we're making in August in our investor call and investor meetings that by August about 90% of the sales reps that we had hired and were on board we’re covering their costs, which is really fast for new sales reps. But they weren't covering their costs in the first quarter. Last year with the new sales reps, we had anecdotes of progress. This year, we've got anecdotes of progress, but there really is too early to make judgment there. I think we've hired terrific people. We've got terrific managers, the launch materials are crisp, it’s nice to be out with an FDA label, which makes the description of what we're doing much easier. I think the other promotional materials and particularly the DTC advertising, I think it's going to help lift things considerably. But with regard to new sales reps performance, anecdotally, encouraging but really too early to make any judgment. Let's hope they do what they -- what was done last year, but it's too early to make that conclusion. So thanks.

Our next question is from the line of Paul Choi with Goldman Sachs. Please proceed with your question.

John, maybe one question just on the new prescription growth. Could you maybe speak to what percentage or the mix I guess is coming from first time or new prescribers? And how much of that versus your new expanded position target base you feel like you're hitting up at this point? And then I have a follow up and an operational question.

Yes, I'll make some comments Aaron, if you have other things you want to add on to this, let me know. To really get into answering that question requires us to look at the country and in sort of a divided way. Our sales team last year was calling on about 50,000 docs not going on with high enough frequency. But with a lot of white space in the country and calling on docs for the first time, we're now have much less white space in the country and we are increasing the frequency of our sales cost, because while we're double the sales force, we've increased the number of targets by about 50%. So to really sort of get into that, you have to look -- I think you've got to look at where we calling on people and what was the impact in the areas that we were calling on people. And there as we added docs and we added -- we went last year from about 20,000 targets to about 50,000 targets. The preponderance, I think over 80% in Aaron will correct me if I’m wrong. Over 80% of that expanded target group became prescribers of VASCEPA last year, which is encouraging. There clearly were prescribers added who are not calling on as well. And now with a label, all of these prescribers have significant opportunity to increase their prescribing. So as we're -- from where we are now we're looking at both how do we take prescribers who we probably weren't calling on, in fact we're convinced we weren’t calling on frequently enough last year, and increased their awareness. Now we have a new label. There’re still somewhat early to the VASCEPA story, but also go to new target, some of which are really being introduced to VASCEPA for the first time. And Aaron if you care to add further?

As John said, we've done very well increasing the number of prescribers. Our real opportunity is with our frequency to drive volume in those prescribers. We still have a small percent of the entire lipid market. As you know, it's a very large market and that's our opportunity, and that's our plan is getting more out of those prescribers and that will driver our success.

Just as a follow up. With regards to your supply chain, some of your API suppliers are from Asia. Could you maybe speak to your amount of inventory on hand, and just how you're thinking about potential contingencies, anything from your overseas suppliers in Asia gets affected or impaired by some of the current things going on?

So we are globally diversifying our supply chain. We are producing nothing in China for our product. And as you may recall, we ended up last year getting out of ahead of this by making sure not only we diversified but which does mitigate risk but also that we were building inventory volume. So certainly the nature of our manufacturing process precludes any product issues, but in terms of supply chain interruption, it would actually be pretty catastrophic before we would -- have to worry about either the ability of us to get product from multiple regions of the country all for us to burn through the whip that we have in hand of non-encapsulated, which is the encapsulation can happen here in the United States, or the surplus we have of inventories that we've built up here, because we just don't know how fast the revenues are going to grow. So I know lots of companies are impacted by that, but I would consider us to be somewhat on the lower end of the risk spectrum unless corona virus becomes, sort of to the extent people just aren't even leaving their homes, but I think in which case much bigger issues. So I think we're okay there. Looking at the clock, I've been giving advice for investors over the years that these things really shouldn't go beyond an hour. Hopefully, these comments have been useful to you. I do think that Amarin is rapidly becoming a new standard of care. It's clearly the fastest growing cardiovascular drug that's out there. We're pleased with the results that we had in 2019. We think we're off to a good start here in 2020. This is a transformational year for us and we look forward to providing you with additional updates as we move forward. So thanks a lot for your interest today, and look forward to speaking with you soon. Bye.

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