Amarin Corporation plc (AMRN) CEO John Thero Presents at Citi's 2018 Global Healthcare Conference (Transcript)

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About: Amarin Corporation PLC (AMRN)
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Amarin Corporation plc (NASDAQ:AMRN) Citi’s 2018 Global Healthcare Conference December 5, 2018 2:10 PM ET

Executives

John Thero - President and Chief Executive Officer

Analysts

Joel Beatty - Citigroup

Joel Beatty

I'm Joel Beatty, one of Citi’s biotech analysts. Thanks very much for joining us today. up with me, I have John Thero, CEO of Amarin. John, thank you very much for joining us. Maybe could you begin by just giving a brief overview of Amarin and tell us what you're excited about in the future.

John Thero

Sure. That makes sense. Just before I start, I will be making forward-looking statements. There are risk involved. Anybody considering investing ought to review our risk factors as described in our SEC filings.

So, Amarin has been pioneering over the last decade an advanced preventative cardiovascular care which we think could – and the PI for the studies just spoke about it being the most significant breakthrough in preventative cardiovascular care in the last 30 years.

So, we just completed a very large global outcome study. That outcome study shows that our drug, on top of controlled cholesterol, so statin-treated patients, resulted in a reduction of an additional 25% and we did that with a good positive tolerability sort of comparable to placebo. So, we’re now getting ready to file for label expansion with the FDA, while in parallel expanding our US commercial footprint, while relying on partners internationally.

Joel Beatty

Okay. As you mentioned, you’ve recently presented the REDUCE-IT results last month at AHA with a 25% benefit on the primary endpoint. Can you tell us a little bit more about the results? There was a lot presented at AHA.

John Thero

Yeah. So, it’s a very important study. And just to take a half a step back, I think people know that cardiovascular disease is the number one cause of death and the most expensive area in healthcare. Cholesterol management has reduced risk roughly 25% to 35% and cholesterol management is terrific. We’re not trying to replace that, but it does mean that there’s 65% to 75% residual risk there.

So, we’re treating patients who despite controlled LDL, so statin-treated patients had risk factors, risk factors like elevated triglycerides or they had a prior cardiovascular event or they're diabetic.

And what we showed in that population was that our drug provided an incremental overall reduction of 25% in major adverse cardiovascular events, which included a 20% reduction in death, a 31% reduction in heart attack, a 28% reduction in stroke. Again, this is all incremental to the reduction that is derived from the statin.

Just to put that in perspective, atorvastatin – Lipitor, we’re not trying to compete with that drug, but that also has roughly a 25% relative risk reduction, and that became about a $12 billion drug before going generic. Just double emphasizing. We’re not competing with that drug, just offering that up for perspective.

The number needed to treat coming out of this study was 21, which interestingly is about half what there is for Lipitor. And we’re very pleased that our drug already has good managed-care coverage and we've priced it in an affordable way, somewhat where statins were that is intended to allow it to be able be used to, hopefully, help millions of patients.

Joel Beatty

Great. So, with the success of REDUCE-IT results, Vascepa has succeeded where other triglyceride-lowering drugs have failed, including Lovaza and fenofibrates on some CETP inhibitors and niacin. Could you tell us about maybe what reason – what’s the mechanism of action behind Vascepa succeeding where others have failed?

John Thero

Sure. So, lipid management, cholesterol management are both very complex areas. So, if this was simple, people would've solved it years ago. So, there’s been many attempts beyond just the ones you’ve talked, all the CETP inhibitors, for example.

The drugs you’ve talked about of all were all ones that did their registration studies back in the last century and then subsequently did outcome studies which failed. Those drugs all have the effect of raising. Despite lowering triglycerides, they also raise LDL or bad cholesterol.

Vascepa is unique not only in terms of its lipid effects. It lowers triglycerides significantly without raising LDL cholesterol, but the effects of the drug go well beyond lipid management.

So, if you look, for example, in each of the eight key steps in the atherosclerotic process beginning with endothelial cell function, through inflammation, through thrombus and plaque stabilization plaque reduction, there's data out there showing that EPA, the eicosapentaenoic acid, the active ingredient in our drug, has a positive effect on each of those steps as well as being a strong antioxidant and antiplatelet and anticoagulant.

So, just like statins do much more than just lower cholesterol, our drug has this multifactorial affect. And by going beyond lipid management alone, we’ve achieved the success that wasn't achieved by those other therapies.

Joel Beatty

Great. So, with those trial results, I believe Amarin plans to pursue label expansion with the FDA. Could you tell us about the path to that?

John Thero

Sure. You're right. so, in the US, we are pursuing label expansion. The trial – the outcome study that we’re referring to, the REDUCE-IT study, was a trial conducted under special protocol assessment agreement with the FDA. We hit not just the primary endpoint, but a key secondary endpoint and numerous other endpoints within that study.

So, we think that the trial itself very well supports label expansion. We are working on the sNDA package. It’s a big study, over 35,000 patient years of study, and we anticipate having that sNDA submitted sometime before the first quarter of 2019. After it’s submitted, we will have discussions with the FDA as to whether they would be reviewing it with a normal timeline which is what we are assuming absent other information or whether they would consider, given the terrific results of the study and the already proven safety of the drug, whether they would consider some form of accelerated review. But at this point in time, we’re assuming a normal review clock.

Joel Beatty

Okay. What impacts, what the label will look like this? Is that included in the SPA agreement looking towards the REDUCE-IT trial design or the REDUCE-IT results themselves?

John Thero

So, we’ll be looking for a label that is directed towards cardiovascular protection, and it would be protection in patients with cardiovascular risk factors. The patients we studied were patients with triglycerides from 135 mg per deciliter and on up with a median of 216. I would expect that each of those elements would likely be in the label.

Joel Beatty

Very good. So, Vascepa is already on the market. At what point are you able to market your cardio-protective claims from REDUCE-IT to physicians?

John Thero

So, over the last – so, Amarin launched Vascepa in 2013 for an important, but niche indication, an indication for patients – based upon a biomarker, of triglycerides of greater than 500 mgs per deciliter, which is an indication associated with pancreatitis.

We have known that what docs really want for the broader application was outcomes data in the cardiovascular space. A much bigger population, roughly one in four adults in the United States have elevated triglycerides, but fewer than 4% of those patients were treated with any therapy because, as Joel was citing earlier, earlier generation therapies have all failed.

So, now with outcomes data, we will be pivoting from actually continuing to promote for the current indication, but also educating physicians relative to the effects of the drug based upon this outcome study.

That will be a multiple step approach. So, we are looking for label expansion and assuming a favorable outcome there. After we get label expansion, we will be doing a full launch of the drug to healthcare professionals and to consumers, which would include an expanded sales force and DTC promotion, television, all those kind of things. That’s still roughly a year away.

Before that point in time, we are moving from what has been spending of roughly $50 million to $60 million per year on research and development, which is a huge amount for most companies, particularly for a company of Amarin’s size and shifting a lot of that spending to the sales and marketing side of things.

So, we've had about 135 sales reps in the United States covering select geographies. We intend to have 400 sales reps in the United States at the start of January 2 of this year. Our targets will be increasing from what has been roughly 20,000 physicians to roughly little over 50,000 physicians. About 85% of those physicians will be general practitioner or family practice docs, about 7% will be cardiologist, about 5% will be endos.

And our intention is to educate them on the results of this study, both the efficacy and safety of the product, while reminding them that the FDA has not yet reviewed these results. Physicians, of course, are welcome to prescribe or not prescribe as they deem fit. But, clearly, the indication will help a year from now, but we think that this data is too important to not get out to physicians immediately.

So, we have had the status now for roughly three weeks. We've begun selectively talking with physician. So far, the data, the feedback has been very encouraging, but it's early. And three weeks isn't enough to be able to draw too many conclusions, but I'd be rather hearing positives than negatives, and it’s almost been entirely universally positive today from the physicians who would be prescribers.

Joel Beatty

Great. As you mentioned, still early in the launch and then you ramp up to the 400 sales reps. Do you have a sense, will 400,000 be enough?

John Thero

So, there are roughly 600,000 physicians in the United States that prescribe statin therapy. Roughly 50,000 of those physicians account for half of those statin prescriptions. It's that roughly 50,000 physicians that we’ll be targeting.

One could argue that greater frequency in targeting those physicians would help. Our view is that we don't yet have the label expansion. We wanted to target the physicians which have the highest prescription histories. We think that the opportunity for the greatest payback is from those physicians.

After we get to label expansion, we will review whether additional expansion makes sense in terms of the size of the field force, but we didn't want to be spending money unproductively here early on. We think we can make a lot of progress off of targeting these 50,000 docs with those 400 sales reps.

Joel Beatty

Beyond targeting docs, what do you see is the importance of targeting consumers to educate them about the REDUCE-IT results? And, I guess, have you been considering that and where are you in that?

John Thero

So, there's a lot of misinformation out there that would be helpful to improve with consumer. I think many consumers think that cholesterol management is enough. They're not aware of the fact that cholesterol management still leaves 65% to 75% of the risk there.

I think they've heard, in many cases, that fish oils work despite tremendous amount of scientific data, clinical trials, four separate publications this year, for example, that show that omega-3 mixtures don't work in lowering your cardiovascular risk. So, I think there's a significant opportunity with consumers.

We will get to consumer education later. Right now, our agreement with the FDA for promotion off label, which is an agreement we entered into several years ago, calls for us having that promotion in a truthful, non-misleading basis to educate healthcare professionals regarding the product and it’s a little trickier to do that with consumers.

So, our initial focus, our focus until we get a label expansion will be largely with the education of healthcare professionals. We think that, A, as the prescribers, they're better positioned to understand this data, but I think after we do get the label expansion, the ability to educate consumers overall on what they may have is misunderstanding.

So, there’s places for dietary supplements for patients who have cardiovascular risk factors. The risk is really too high to be taking a chance with unproven therapy. They ought to be using a proven therapy.

Ours works. It’s affordable. And that will be part of sort of the second wave of commercialization and more importantly sort of after the label expansion.

Joel Beatty

Got it. Since the REDUCE-IT results, I've seen a lot of news publications about the results. So, seeing a lot of positive things. I think one of the critiques I've noticed has come up in some of them is about a CRP increase in the placebo arm and what that means for the results of REDUCE-IT. Can you provide some perspective on that?

John Thero

So,, any time you have game-changing results, it's always good to have those results subject to scrutiny. And, intentionally, we had the results presented in a peer-reviewed form at the American Heart Association and we had the results published in the New England Journal of Medicine.

And in both of those forms, the overwhelming consensus is that this is a drug that provides significant cardiovascular protection beyond cholesterol management.

In making that major change, we do run across folks who look at these results and say, well, these are too good to be true. And we would acknowledge that if this were easy to do, people would've done it a long time ago. We have been doing over 20 publications per year for the last five years and a lot of this sort of gets into mechanisms of action.

As people look at the effects of our drug and say, well, jeez, that's too much of a risk reduction based upon triglyceride lowering. We’d say we actually agree with you. And that's been a thesis of our study throughout. We think triglycerides is important, but we think that the effects of our drug goes well beyond that.

So, I think some folks who are looking at our effects and didn't understand it started saying, well, where else could it have come from.

I think, subsequently, as they've had more time to study it, I think those people are beginning to better appreciate the effects of Vascepa beyond lipid modification, but, initially, they began to sort of look into, well, jeez, what about this and what about that.

One of the effects of our drug is that Vascepa significantly lowers hsCRP or log hsCRP depending on which measure one believes to be most appropriate. And there is some other data out there suggesting that lowering inflammation provides cardiovascular benefit and we think that's probably part of the contribution of Vascepa because Vascepa does significantly lower hsCRP as a measure of inflammation.

Some of those folks would also sort of look and say, well, jeez, hsCRP changed a bit on the placebo arm of the study. And we say okay. A, those aren't big changes; B, this is why you’d have a control arm of a study; and C, the sort of the way they were looking at comparing, it’s not statistically valid to look at changes in medians as opposed to differences on a patient by patient basis and taking the median of that where the numbers came out to be quite a bit different.

It's fine for people to be challenging the data. I think those who looked at that data, the closest – and I don't want to really get into tremendous detail. Anybody wants to look at that topic in more detail is welcome to go under our website, under Investor Relations. There’s frequently asked questions and discussions of these kinds of topics. I think this is largely a creation of our competitors trying to say, oh, wait for us, wait for us. But even those competitors have broadly acknowledged that the results of the study can't be explained by the questions that they're asking.

And I do think that there is an evolution of understanding even amongst those academics that the effects are much broader than lipid modification.

I’ll go on to say that, in the field, in the promotion of this, and it’s only three weeks into it, we've not heard those concerns from a single physician. So, a little bit of a different world between those who are sort of academic looking at it versus those who are practicing and prescribing every day.

Joel Beatty

Very good. Sort of, recently, Amarin had an equity raise. Can you tell us a little bit about how that affects Amarin’s capitalization and the cash runway?

John Thero

So, recently, we did raise $200 million that was added to roughly $81 million that we began the quarter with. And we believe that, with those funds, it provides Amarin with a runway under most scenarios to get to cash flow positivity. So, we appreciate the support from investors in that financing.

It was a relatively small deal, given our market cap. I'm told by the bankers that it was oversubscribed in about an hour. So, glad that that was done.

And the topic of – sort of interesting to me that the topic of financing had become such a pervasive topic where it felt as though, well, whether we needed to finance right then or we could have waited just addressing the financing overhang and getting it behind us made sense.

Hopefully, now the focus will remain with the value of this drug, its importance towards potentially helping millions of patients, our launch of the drug here based upon the sort of data we have today and then the launch of it after we get label expansion post sNDA approval.

Joel Beatty

Great. We’ve talked some about the opportunity in the US, and that's where the large majority of revenue is coming from right now. Could you tell us about the plans outside of the US for Vascepa?

John Thero

Heart disease is a global phenomenon and it’s really the number one cause of death in almost every country of the world. Before the outcome study results, we selectively partnered in geographies where we thought we had an opportunity to be first.

So, we have a clinical trial going on with a partner in China where we think we have an opportunity to be first. We’re in the Middle East, and that partner has actually gotten approval for us in Lebanon and the United Arab Emirates already. And not long ago we partnered with a very good company in Canada.

And that leaves major markets to be pursued. People often ask about the European opportunity, which is significant. We elected not to pursue that before REDUCE-IT results for a few reasons.

One is, there was an earlier generation drug Lovaza in the US, Omacor in Europe. And Omacor was launched in Europe by a different company in each country and has different labeling and different reimbursement, different dosing country by country. And we thought sort of trying to piggyback on top of that didn't make sense.

Rather, we’d prefer to have had outcomes data and be able to go to Europe on a pan-European basis, hopefully, with a broad prevention indication, better reimbursement, et cetera.

We are in need of the regulatory package that we have for the to do the regulatory filing for the EU. Right now, our thoughts is that the promotion of Vascepa in Europe should be done by a partner. We have not decided yet as to whether it would be best for valuation of the company to do that partnering before we do the regulatory filing or after. There are pros and cons to both.

The pro of doing it before, those partners would say they add value to the regulatory process and they can begin to get ready for commercialization. The other side is, if you wait and derisk it, you potentially get different economics, while keeping certain flexibility along the way.

Meeting with a variety of investors today, somewhat surprisingly, actually a majority of them were advocating towards the wait and keep flexibility side of things. We’re not at a stage where we’ve had to make that decision yet. We have had inquiries, but we don't yet have the data package ready. So, we’ll continue to look at that.

There are other geographies in the world where we’ll also consider partners. Some of the folks who have approached us for Europe have made inquiries about other areas of the world.

And the US is the biggest market here. We’re going to make sure we get that right, but this is a global opportunity. So, we're working those in parallel.

Joel Beatty

Right. A question about intellectual property. In the conversation of metformin and regulatory exclusivity run out in 2020, but it seems as if there can be of runway well beyond that Vascepa in the US. Could you tell us a little bit about what gives you confidence in that?

John Thero

So, the protection of Vascepa is really at three levels these days. One is, it is difficult to manufacture and we think we have economies of scale.

Two is, as you mentioned, there is regulatory exclusivity that goes into 2020 that's based upon the NCE status of our product.

And the last is our patents. We now have over 60 patents on the product. There are ANDA filers. Any good product gets ANDA filers. It would be almost insulting if there weren’t, I guess.

There were four. One of them dropped out fairly early. Another was Teva. They settled. They could come into the market in August 2029, so about 11 years from now. The other two, Hikma and Dr. Reddy's continue in the litigation process. There’s been no court date set yet. There have been Markman hearings.

I think the results coming out of that claims construction was very favorable to us. At least one of the claimant says acknowledge that if they were to launch, they would be infringing upon our patents. I think it's sort of impossible not to. Our patents cover key elements of the label for the product and you can’t have a generic without having that label. We intend to defend our patents vigorously.

I think they’d have to – if they're acknowledging that they infringe, they’d have to invalidate these patents. And these patents were heavily prosecuted through the US Patent Office. And did I say we intend to defend them vigorously.

Joel Beatty

Got it. With the recent results from the REDUCE-IT trial, does that provide any additional opportunities for IP?

John Thero

We have had additional patent filings and we may have additional patent filings based upon the REDUCE-IT results, yes.

Joel Beatty

Got it. And with Epanova by AstraZeneca is in outcomes trials as well, they could be reading out in about a year or so. What are your thoughts on how that drug compares to Vascepa?

John Thero

So, in any big market, and this is by account a big market, very few drugs out there that are addressing one in four adults, it's not surprising to have competition. We think that the unique single core molecule that we have in our drug and its effect of not raising LDL and its strong tolerability profile positions us well.

But I hope they succeed. They're talking about results in 2020. They're studying a slightly different patient population. They're studying patients with elevated triglycerides and low HDL. Elevated triglycerides, they defined as 200 above. We had a 38% relative risk reduction in that higher risk patient population.

I think, in many regards, having two players ends up expanding a market faster. So, I hope they succeed. Their product does include DHA in it. Their earlier studies, and all studies of products including DHA, shows that it increases LDL. And, historically, products that have included DHA have failed in cardiovascular outcome studies. But they’ve picked a high enough risk population that they may succeed.

If they do succeed, we do believe that they infringe certain of our patents which we will evaluate at that point in time and we do think that we’ll compete with them on the basis of efficacy, of tolerability, and not raising LDL. But that's still ways away.

Joel Beatty

Okay. So, earlier, we touched briefly on managed care access for Vascepa. I’d like to discuss that a little bit more. I guess, do you see – in terms of looking to grow further Vascepa use, is it important to get a managed care access broader than it is now and to what extent or is it already where it needs to be?

John Thero

So, I imagine that every CEO would talk about, it would be helpful to have broader managed care coverage, but let me calibrate where we are.

So, having been in the marketplace now for what will soon be six years, we have a product that's affordably priced. It’s priced at a level that had statins been in the market and still branded and adjusted for inflation, we’re sort of at that price. We’re slightly lower than that price.

We’re at a price where I'm certain given the high cost of heart attacks and strokes, et cetera, that the pharmacoeconomic analysis has kind of come out to be favorable on this.

But over the last five, six years, roughly half or more than half of our scripts have been off-label, albeit based upon a biomarker indication as opposed to a prevention indication.

Reimbursement has been good. Approval rates for reimbursement are near 80%, which are neck and neck with generic Lovaza, the earlier generation product. I think most products would be very pleased with nearly 80% approval rates.

But managed care is not perfect. There are some plans that won't expand – a minority, but some plans that won't expand the reimbursement until the label gets changed. But for the most part, we've got, I think, over 90% of Medicare Part D lives on formulary, mostly on tier 2 unrestricted, over 80% of commercial lives on formulary mostly on tier 2 unrestricted. We don't do a lot of Medicaid. The cost of manufacturing our product is too high. We would lose money on Medicaid.

So, I think our starting point is very good. We will be calling on a lot of new doctors, doctors who are unfamiliar with Vascepa. And there's always a preconceived notion that “new drugs” aren't reimbursed.

I think that, as they try Vascepa, they'll find favorably that the coverage is very good. There are pockets of the country where it's not quite as good as in other pockets. But I use Vascepa. Don't need it, but I guess I'm off-label, but Aetna as an insurer, they’ve never pushed back on it, and I know a lot of people who have used it off-label and haven't had any issue. So, hopefully, that continues.

Joel Beatty

It’s not necessarily a launch, but the growth in sales that’s expected to come after REDUCE-IT results, how will Amarin be evaluating that? What metrics will you use to be evaluating whether the growth in sales is a success?

John Thero

So, a lot of different metrics, right? So, first, we’ve got to remind ourselves that there's a couple of launches coming up. There is a launch that’s – maybe call it three. We’ve got one that’s sort of started now with a limited size sales force. We’ve got another one that starts in January when the sales force is larger.

The New England Journal of Medicine publication right now is online, but not in print. That will help when it is in print. And then, there's, of course, the larger launch after we get label expansion.

We’ll be evaluating our launch based upon those physicians who already know Vascepa and what are they doing with the product versus what physicians who are brand new to Vascepa are doing with the product.

For someone who is new to the product – some people tell me, jeez, these results are so good, the product is going to sell itself. The data suggest that, for any product, you have to call on a doc five or six times before you can really begin to affect practice behaviors.

For some of our existing docs, anecdotally, they’ve said wonderful things. And they've said, jeez, this drug is – this is so good a result, I'm going to call my patients, especially just to switch their mom to this drug, which all sounds great, but I don't believe them.

I think that's wonderful. I think that’s great that they're that enthused about the data, but I rarely see docs changing the scheduling of their patients to do something.

So, this is not a drug for hospital use. This is not a drug for acute use. These patients tend to come back to their physicians once per year. And I would hope to see that, amongst those docs who know the product the best, that we would see increased scripts soon, that the docs who are new to it will begin to build scripts.

The real measure here isn't going to be the number of docs that prescribe it. I think it’s going to be very easy to convince physicians that this data is terrific and they ought to be prescribing it.

The real measure is going to be, do they prescribe it on 1% of their patients. We can make a lot of money and help a lot of patients at 1% of 90 million patients, right? So, is it 5% of the patients? That will be a really great benefit to society and you guys would be extremely happy if it got to that way. Or is it all 25%? Then, we’re about twice – that’s about $80 billion. I don't think we'll get there, but that's the size of the potential opportunity.

But that level of penetration – I hear some people saying, well, jeez, why wouldn't you prescribe if the drug is safe, it's affordable, provides 25% risk reduction, why wouldn't you prescribe it? We’ll be measuring all of these things, but it's still very early here, just three weeks after the data.

Joel Beatty

You've mentioned 25% of patients is kind of this large – characterizing the large potential market opportunity. Just curious how do you get to the 25%? What was the cut?

John Thero

So, I’ll take it half a step back, in that no drug sort of gets at the full population ever. And with most new therapies, physicians start with the sickest of patients and then migrate from there.

So, I suspect that docs will start with patients who are already on statin therapy and have risk factors like elevated triglycerides or they're diabetic or they've had a prior cardiovascular event. That's roughly 15 million patients. And then, they'll move to prediabetics. Just sort of like statins started with LDLs up over 200 and then moved it down to 200 and to 180 and 150 and 165 and 100 and 70 and then nothing. I'm seeing so many back to 70. I suspect that this will expand over time.

The 90 million are patients in the United States who have triglycerides and other risk factors. Triglycerides, 135 and above. So, it's about twice the number of people who have elevated triglycerides as have elevated cholesterol.

One of the interesting findings from the REDUCE-IT study, which is that while we think that triglyceride reduction was a part of the solution, not the full solution, but a part of the solution, was that the outcomes data seem to be independent of triglyceride level, so that the 25% risk reduction was relatively consistent regardless of whether the triglyceride baseline was greater than 200 or from 150 to 200 or less than 150 mgs per deciliter.

So, the population is potentially ultimately even larger than that bottom floor of 135. But as I say, I think physicians will start with the riskier patients and it will take some time before it gets to just sort of moving beyond that.

Joel Beatty

Got it. So, regardless of how the population is defined, this is a very large opportunity. What are your thoughts on whether it makes sense to partner to further target physicians beyond the 400 sales reps that you have?

John Thero

So, you're talking about in the United States?

Joel Beatty

Yes.

John Thero

So, in the United States, we've already got great data. We've got great KOL relationships. We've got broad managed-care coverage. We've got proven supply. I think there is no reason why we can't do this on our own.

But that being said, we work for our shareholders. So, we’re always looking to maximize value. But, right now, we’re focusing on that which we can control. We’re hiring sales reps. We’re getting ready for the sNDA. We’re promoting this to physicians and we’re going to grow it.

If along the way an opportunity comes to do something better, we’ll consider that at that point in time, but we’re very confident that we can grow this significantly and create value on our own.

Joel Beatty

Got it. And then, thinking about defining the exact patient population, I wonder if guidelines could help do that at some point in time? How important do you see guidelines in terms of marketing and launching Vascepa?

John Thero

So, the cardiovascular guidelines tend to get updated every five years. They actually just got updated and a number of physicians at the American Heart Association meeting commented that a record has been set that was the fastest that guidelines were ever considered to be obsolete, essentially two hours later when the REDUCE-IT results were presented.

That being said, the guidelines have always been on products that had outcomes data. We know outcomes data for those guidelines are based upon cholesterol guidelines where we’re not a cholesterol drug. We’re for cardiovascular risk beyond cholesterol management.

And guidelines can be helpful. Guidelines can potentially – particularly be helpful with managed care. But our managed care coverage is already very good. I think label will help with certain of those outliers on the managed care side, but the number needed to treat are 21, affordable cost product, I don't think we need guidelines really to drive the added managed-care coverage.

And most GPs couldn't tell you what's in the guidelines to begin with. I think cardiologists will study this data and I think will probably be the fastest group in terms of their uptake that they’ll get this data and they won't be waiting for guidelines. Guidelines would be nice, but not needed.

Joel Beatty

Got it, great. I think we have just a couple of minutes left, I guess to wrap it up, could you tell us about what you see as the key events for Amarin that you're looking to execute on over the next year?

John Thero

Well, central, of course, to what we’re doing is getting a sNDA submitted and getting that approval because that will allow us to significantly expand our commercialization.

Along the way, we will be making some decisions as to whether we – when we want to partner and where. And then, of course, we’re expanding our sales force. We think that we’ll have roughly 400 sales reps on the street early in January and we’ll watch scripts, hopefully, grow from there.

Question-and-Answer Session

Q -Joel Beatty

John Thero

Thank you for the invitation again and thank you in the audience for your listening. Appreciate it. Thanks.