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Edited Transcript of AMRN conference call or presentation 18-Nov-19 9:30pm GMT
Amarin Corporation PLC O Webcast Discussion Of Presented Data at American Heart Assocition's 2019 Scientific Sessions
Dublin Nov 19, 2019 (Thomson StreetEvents) -- Edited Transcript of Amarin Corporation PLC conference call or presentation Monday, November 18, 2019 at 9:30:00pm GMT
TEXT version of Transcript
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Corporate Participants
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* Craig B. Granowitz
Amarin Corporation plc - Chief Medical Officer & Senior VP
* Elisabeth Schwartz
Amarin Corporation plc - Senior Director of IR
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Conference Call Participants
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* Deepak Bhatt
* Matthew Budoff
* William Weintraub
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Presentation
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Operator [1]
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Greetings. Welcome to the AHA investor discussion conference call. (Operator Instructions) Please note this conference is being recorded.
I would now like to turn the conference over to your host, Elisabeth Schwartz. Thank you. You may begin.
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Elisabeth Schwartz, Amarin Corporation plc - Senior Director of IR [2]
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Welcome to today's discussion to explore for our investment community the several important new data sets and analyses related to Vascepa and REDUCE-IT as presented at the 2019 American Heart Association's Scientific Sessions here in Philadelphia.
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 Vascepa clinical data and cost-effectiveness analyses and expectations regarding the application of these data to clinical use, in reimbursement and regulatory settings and to commercial prospects for Vascepa. And these statements are based on information available to us today, November 18, 2019.
We may not actually meet the expectations disclosed in our forward-looking statements. Actual results or events could differ materially. We assume no obligation to update these statements as circumstances change. For additional information concerning these factors that could cause actual results to differ materially, please see the Forward-Looking Statements section and the Risk Factors section of our most recent Form 10-Q filed with the SEC.
This call is intended for investors in Amarin and is not intended to promote the use of Amarin's Vascepa outside its approved indication.
I will now turn the call over to Dr. Craig Granowitz, the Chief Medical Officer of Amarin.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [3]
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Thanks, Elisabeth, and thank you all to our panelists and listeners today for joining us. We're excited here -- to be here in Philadelphia at the conclusion of the American Heart Association's Scientific Session. We're fortunate to have 3 clinicians/researchers that are immersed in Vascepa-related sciences and have presented here at AHA to speak with us today: Doctors Matthew Budoff, Deepak Bhatt and William Weintraub. I'll give a quick recap of the presentations by each of these 3 research physicians, and then we'll move into a discussion of some of the key issues with the results.
Dr. Budoff presented this morning on the interim 9-month results of the 18-month EVAPORATE study. EVAPORATE is a first study in the U.S. to use multidetector computed tomography to evaluate the effects of icosapent ethyl as an adjunct to statin therapy on plaque characteristics in a high cardiovascular-risk population with persistently high triglyceride level. Patients underwent interim scans at 9 months and are currently being followed for an additional 9 months. Final results of this investigator-initiated study are anticipated in early 2020.
Dr. Bhatt spoke yesterday about REDUCE-IT USA. These prespecified REDUCE-IT subgroup analyses showed substantial risk reduction in the U.S. patients treated with icosapent ethyl 4 grams a day versus placebo across all predefined composite and individual primary and secondary endpoint, including a 31% relative risk reduction and a 6.5% absolute risk reduction in first occurrence of 5-point MACE. This corresponds to a number needed to treat of 15 and a significant 30% relative and 2.6% absolute risk reduction or a number needed to treat of 39 in all-cause mortality in this U.S. subgroup. I want to emphasize that these analyses of this data in the U.S. population in most studies are usually not as pronounced as what we say in the REDUCE-IT USA analysis.
Finally, we will speak to Dr. Weintraub about the preliminary analysis of the cost effectiveness of icosapent ethyl. In this combined patient level and simulation lifetime cost-effectiveness analysis, icosapent ethyl in high cardiovascular-risk patients showed an exceptional benefit with cardiovascular event reduction as well as cost savings in trial and over patients' lifetime in many simulations.
Finding of cost effectiveness of medical therapies are rare. This analysis considered the current market cost for Vascepa and the potential savings from avoiding major MACE events such as stroke and heart attack, the cost of which can often be very high. As is typical, the cost-effectiveness analysis were not prespecified as part of reducing clinical study design but did rely on the landmark results.
So Matt, I'd like to start with you. You're Professor of Medicine and Endowed Chair at the UCLA School of Medicine and Program Director of the Lundquist Institute. So Matt, if you could just give a summary of some of the key points that you wanted to convey this morning at the late-breaker. And I do want to note that you were the first on the agenda for the morning. So clearly, there was a high degree of interest in the sponsors of the session to hear what you had to say in the EVAPORATE study.
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Matthew Budoff, [4]
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Yes. And I think it was very, very well received by the physicians in the audience. Basically, we demonstrated that, over just a short 9-month analysis, that there was generally a uniform plaque regression in the patients who received Vascepa as compared to those patients who received placebo. Because it was a small number of patients, it was an 80-person trial, and we only had follow-up in 67 patients at the interim analysis, the power was a little diminished because we powered it based on an 18-month trial. But I have to say that while the primary endpoint was 21% reduced, which was not enough to stop the trial, it was very concordant with all the other parameters. For example, total plaque went down by 42% with a p-value of 0.004, and that's -- we have not seen that type of plaque stabilization or slowing of plaque progression with other therapies that we've studied, especially over a short interim time frame of only 9 months.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [5]
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Now, Matt, that's a really helpful summary. And I guess there are some questions that I've heard this morning about what does the mechanistic study actually mean, why do the study -- what -- where do you think that's going to add to the body of literature. And I'll note that Dr. Bhatt was also an investigator on this trial as well. But how, Matt, do you see this kind of fitting in? What role does this play in terms of our understanding of the field?
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Matthew Budoff, [6]
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Well, I think a lot of clinicians were surprised, to say the least, at the robustness of the REDUCE-IT study and how large the benefit was, and they want to understand better. We're telling them it's not just triglycerides, that it's not only different things, and we don't know what it is. So when you look at the primary endpoints of REDUCE-IT, all of them that could be artherosclerotic line up and show benefit. So I think it suggests that this is a direct anti-artherosclerotic benefit, but you can't derive that solely from the REDUCE-IT study. Now we can say with confidence, based on the results of EVAPORATE, that there is an anti-atherosclerotic property at play here that's supplemental to all of the other benefits that we've already seen with Vascepa.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [7]
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Dr. Bhatt, I know that there have been a number of questions asked of you, including even last week at the FDA meeting, about time to curve separation. And I think sort of putting that in context with the mechanistic results of Matt's study might be very helpful context for people to understand sort of these intermediate signals in the context of a clinical event. Could you shed some light on that?
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Deepak Bhatt, [8]
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I think that's a great question. And in the REDUCE-IT trial, we saw benefit in the 2 major cohorts, which were the patients enrolled with secondary prevention. By that, I mean stable patients with coronary artery disease or cerebrovascular disease or peripheral artery disease. As well, we saw benefits in patients who are high-risk primary prevention. By that, specifically, what we enrolled were people with diabetes and at least one other cardiovascular risk factor. So in that population of patients, there was significant benefit. The drug worked a little bit differently in terms of timing of that benefit kicking in. In the secondary prevention cohort, it looked like the curves were really starting to separate at about a year, whereas it took a couple of years in the primary prevention cohort. And that makes sense because that's what we saw in the statin trials. And in fact, if we had studied really high-risk patients, like people coming in with heart attacks or acute strokes, then I think the curves would have separated even sooner. So it really just has to do with the baseline risk.
But what I think Dr. Budoff's study has nicely done, it's done a lot of things. I mean, it's shown for those doctors that really want to see, what's the mechanism of action, if shown, will look. The plaque in the arteries looks likely to progress. So that's a really powerful visual image. But beyond that, there's another message that is a bit more subtle that, at least to my knowledge, no one has explicitly stated. This was an interim analysis. It was just 9 months. It's meant to be an 18-month study. But I'm really glad Dr. Budoff took a look, prespecified all or part of the plan that he'd laid out because it tells me that there are benefits that are kicking in early. So if you're a physician and you see the patients that we enrolled in REDUCE-IT were stable patients, again, they're not in the throes of a heart attack or that sort of patient, you're going to throw the kitchen sink at them in terms of risk reduction. They're pretty stable. They're in the office. They're not actually complaining of anything. They're doing okay. It'd be easy to just say, look, I'll see you back in a year. But the problem with that approach now we see with a REDUCE-IT-like patient that's out there in practice, their plaque is progressing in the course of that year. So this really provides an impetus for why a physician needs to pull the trigger and act sooner with respect to prescribe it.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [9]
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No, I think that's really important context. One of the other sessions I was at yesterday was talking about the effects both on the particles and on inflammation. And Matt, I don't know if you want to comment at all because that might tie into -- one of the questions I think comes up is, why are there so many endpoints that are looked at in this? What are all these different surrogates of total plaque and low attenuation plaque and calcified plaque? Maybe you could help give, again, some of our investors some context of what all of that means because it's just some terminology that might be confusing.
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Matthew Budoff, [10]
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Well, absolutely. So I think when we look towards therapies that have both presumed the anti-atherosclerotic effect and an anti-inflammatory effect, then we start to think about things like the low attenuation plaque, which what we think of kind of is the necrotic core, the really vulnerable plaque, that might be most likely to rupture.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [11]
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And what happens when the plaque ruptures, Matt?
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Matthew Budoff, [12]
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When a plaque ruptures, patients have an acute heart attack or an acute stroke. The artery gets occluded, and they end up with an immediate event. 1/3 of people die suddenly when these plaques rupture.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [13]
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And that really was the endpoint, right, Deepak, of REDUCE-IT? That's sort of the clinical consequence of a plaque gone bad.
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Deepak Bhatt, [14]
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Look, it's a great one-two punch when you think about EVAPORATE and REDUCE-IT. You've got basic mechanistic data now by imaging and a clinical trial that shows clear-cut benefits. So it's a really nice package scientifically. For physicians out there that want mechanism of action, now we've got one. Now there are several other mechanisms of action at play too, I think, with icosapent ethyl with the ability to retard plaque progression. That's pretty important.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [15]
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Right. So Matt, I'm sorry I interrupted you talking about some of the different endpoints of the study.
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Matthew Budoff, [16]
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Yes. So obviously, when you think about just overall progression in your coronary arteries, you would use an endpoint like total plaque, and that was very significantly reduced in the EVAPORATE trial. We focused on this more vulnerable plaque because of some of the evidence from REDUCE-IT that sudden death was reduced. So there was a signal there that maybe this plaque ruptures. There's some data from abroad, from Japan, the CHERRY study, and other studies that have also suggested that, that would be a good target to look at specifically because of a drug that has these pleiotropic or multiple effects on the vasculature.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [17]
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And I think you mentioned at least one point to me that there've been a number of these imaging studies done, mostly in Japan, not in the U.S., and that's one of the unique aspects of EVAPORATE. But has there been a difference that have been seen in the Japanese studies with different omega-3 preparations?
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Matthew Budoff, [18]
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Yes. So there's been a number of trials. There's been 2 large-scale trials, 1 in the U.S. and 1 outside the U.S., that looked at 4 grams of Lovaza without showing significant benefits.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [19]
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And Lovaza is what part of...
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Matthew Budoff, [20]
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EPA and DHA, mixed -- combination pill. And both of those trials failed to show benefit even out to 2 years. So I think this is much different than the EPA-DHA mix data that we've seen from imaging. And the Japanese data did line up very nicely with 1.8 grams of EPA. But again, Japanese populations, invasive imaging, where they're putting catheters into people's coronary arteries, things that would be really hard to emulate in the United States.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [21]
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Yes. And that's very helpful context. I think one of the other questions that people have asked me is the interim analysis threshold and the statistical benchmark for that, which seems awfully high, right? If you could talk a little bit about how the statistics might be. And I don't want to put you on the spot. I know you're not a statistician, but I'm not sure that everyone really understands that the hurdles at an interim analysis are quite high to stop a study.
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Matthew Budoff, [22]
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Yes. And basically, what you're saying is if there's overwhelming efficacy, if the drug is so good at an early time point, then you can almost argue it's unethical to continue the study, just like we stop clinical trials early when there's overwhelming benefit because we don't want to keep people on placebo or keep people off of this therapy. So we didn't hit that interim analysis based on the primary endpoint that we chose. But again, had we chosen total plaque, which is a very reasonable endpoint in many trials, we would have actually stopped the trial early because total plaque came in at P 0.004, which is less than the necessary stopping parameter. So we can -- the Steering Committee can obviously take some responsibility for picking the wrong endpoint, but hindsight is 2020. But the trial is still positive, and the trial is still ongoing, so I think that it's good news. And I think based on my conversations at the American Heart Association after the presentation, many physicians feel much more comfortable now, not people who just live and die based on clinical trials but those that want to understand the mechanism, that this adds a lot to their confidence in moving forward with the use of icosapent ethyl in their practice.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [23]
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No, that's helpful. There was one other question. I know you showed a slide at the meeting today about the placebo controls, and I know you covered a tremendous amount of data very quickly on that. And this might be a point to help clarify. What was actually done? And why is it meaningful?
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Matthew Budoff, [24]
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Yes. So since the REDUCE-IT trial was published and after we started EVAPORATE, there were some questions about the mineral oil placebo that was used and whether that was contributing to harm rather than -- or offsetting some of the benefit of icosapent ethyl. We had already started EVAPORATE, so EVAPORATE was using the same mineral oil placebo that we used in REDUCE-IT. So what we did is we matched that placebo group to another group of patients who are on a different placebo, one that's made out of cellulose that everybody acknowledges is completely inert and has no adverse properties to it. And we showed that the rate of progression on patients on mineral oil was identical to the rate of progression of those patients on an inert cellulose placebo. So hopefully, laying any concerns about mineral oil being bad, rather now all the benefit is on icosapent ethyl being good.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [25]
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No, that's very helpful. And again, I just want to clarify one other point before we left for Dr. Weintraub out of the conversation. But -- so you showed a curve, and it looked like there was a 45-degree line, and there were all these dots on the curve. Maybe you can just sort of put that in context of what that meant and why did that give you comfort and confidence because I'm not sure everyone is so familiar with looking at that kind of scatter plot.
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Matthew Budoff, [26]
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Yes. No, absolutely. So this is basically just putting all of the rates of progression among both cohorts, the -- there were blue dots on the curve, if you saw it on the slide, that were represented the cellulose placebo from another randomized trial, and there were red dots that represented EVAPORATE placebo patients. And the line of identity went -- was identical for the two. In other words, we graphed out what is the rate of progression among those 2 cohorts, and they were -- the lines were superimposed.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [27]
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Right. So each one of those dots was an individual patient over that time course and sort of seeing that there was an equal distribution across both sides, which said, statistically, there was absolutely no difference in the rate of change between those 2 of the parameters you're looking at.
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Matthew Budoff, [28]
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Absolutely. And what people need to understand is when we're up there presenting, as we all do fairly frequently, there's literally a giant clock that only we can see that is counting down towards 0. And when it hit 0, you have to stop talking. So...
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [29]
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And it's flashing red so...
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Matthew Budoff, [30]
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Yes, yes. Yes, yes.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [31]
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And they turn off the microphone.
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Matthew Budoff, [32]
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But -- so we are under some time pressure. So yes, so we couldn't put in all of the data, obviously, that we would have liked to in a more open presentation. I was limited to 10 minutes to present the entire spectrum of data. But yes, that line basically shows that there's -- with all the individual data points, that there's no difference. And we did multiple analyses with all different types of plaque. And regardless of what we looked at, their rates of progression on cellulose placebo, inert placebo was identical to mineral oil placebo. And I did, I think, hopefully, to at least the scientists and the clinicians in the room, effectively convey that mineral oil, therefore, is not the bad player that some people have accused it of being.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [33]
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No, thanks. Thank you. And I think that was another important analysis that came out of the study. Bill, I wanted to turn our attention to you. We're very fortunate to have William Weintraub here from the Medstar Institute, who has a long history of doing cost effectiveness analyses as well. And Bill, you're also a cardiologist also?
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William Weintraub, [34]
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I am.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [35]
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So he's a clinical cardiologist and a health economist with a lot of publications in this particular area and really an acknowledged expert. And I give Dr. Boden and the Steering Committee a lot of credit for reaching out and engaging with Bill on the cost effectiveness that was presented here at the meeting. And again, this was done with the support of Amarin but really independent of Amarin, knowing all the sensitivities, particularly around cost effectiveness analyses.
Bill, you might want to just share just in a minute or 2 your perspective on the study and its design. And again, this was done in the overall total population, not the U.S. population. One of the reasons I wanted to go to the total population first before asking Dr. Bhatt to comment on the U.S. population is I don't want to confuse the 2 because I think having them presented at the same meeting could be potentially confusing to people. So you studied the overall REDUCE-IT population.
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William Weintraub, [36]
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Right. We did. We looked at the U.S. population too, but we started out with the total population. We used U.S. prices, but we used the total population, which is the typical way this is done. Now -- and with REDUCE-IT, we found a 25% relative risk reduction for the first or primary endpoint but 30% overall. In the cost-effective analysis, we used all events, not just the first event. So here, we have a relatively inexpensive pharmaceutical, (inaudible) pharmaceutical. And we have a remarkable reduction in event rates, 30%. This is an unusual situation.
Now what we did is we have to use a number of different costs inputs. We have to look at the cost of the drug. We used what is called SSR net pricing, which we strongly believe that's the right price to use in cost-effective analyses. We used different input values for the cost of events. We used Optum cost, which gives a very broad distribution of costs in patients under the age of 65 and Medicare costs over the age of 65 for our base-case analysis.
Then the other thing we have to look at is utility, how well patients are functioning on scale 0 to 1, with 1 being perfect health and functioning, 0 being generally mortality. We use utility values from the literature, and then we have to estimate survival. Now the remarkable thing about what we did here is that we had 5 full years of in-trial data. And with that, we could look in-trial not using a simulation, not using estimation but using real data. And with that, we found that icosapent ethyl in our base-case analysis is a dominant strategy and as we offer better outcomes at lower cost.
For (inaudible) pharmaceutical, none of us have ever seen anything quite like it before, very unusual and very important. This carried over into our long-term survival analysis as well. But there always has to be a partial simulation because we have to estimate event rates that we haven't measured. We have to estimate survival. Nonetheless, both of these work together to suggest that we have remarkably efficacious therapy, which offers great value. And at least, our preliminary results do suggest that it is dominant, that we went for better outcome at lower cost.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [37]
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Thanks, Bob. A very good summary. And again, some of the questions that I've been asked on a number of occasions, is there was an independent group called ICER, that also did an analysis. They came up with somewhat different findings, even though I think they use the same drug cost. Maybe you could talk a bit about the ICER analysis, what are the strengths and weaknesses of each one of them because ultimately, it's sort of this constellation of models that are out there, right?
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William Weintraub, [38]
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All right. So I mean, they've also found that the cost of icosapent ethyl is highly cost-effective is using most benchmarks. They did not find it to be a dominant strategy. But still, we've got a relatively remarkable incremental cost effectiveness ratio of $18,000 for quality adjusted life year gain, but still very good by almost any measure. The difference is to shift from dominant to $18,000. It's actually not that big. It sounds a lot, but it's actually a very small shift that can result in that. What do they do that was different from what we did. First of all, that was a total simulation. They did not have access to the clinical trial data.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [39]
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And so, Bill, for -- I'm sorry to interrupt, but what does that mean the simulation versus actual clinical data, because I think these are concepts, and not everyone is so familiar with.
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William Weintraub, [40]
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Well, thank you for interrupting. Allow me to clarify that. So a simulation would mean you take results of the trial. It's not that it's made up. I don't want you people to think that this is some kind of fantasy, that's not the case. What they did is they took the overall results of the trial as published in the first -- REDUCE-IT paper and then develop a mathematical model from that, that allows them to estimate the cost effectiveness. That can be -- that works pretty well, but it's not as good as having the actual data in your hands. The other thing is that there's going to be variation. We can look at the distribution of things a lot better when we have the data. So everyone understands that not all patients are the same. You have the distribution of patients. But if you only have the sort of the bottom line results, you can't look at that distribution the same way you can get all of your data.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [41]
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Now I also understand that they only looked at some of the endpoints, not all of the primary endpoints of the study as well?
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William Weintraub, [42]
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Right. So they don't have access to all of the endpoints. We have actual data. So we could look at heart failure hospitalization, AFib hospitalizations. We could look at things that they didn't have access to.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [43]
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All right. That's helpful context of how you could get the range. I think another term that isn't familiar to many, is what is dominant actually mean and how to try to understand what dominant actually would represent.
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William Weintraub, [44]
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All right. So most of the time in a cost-effective analysis for a new therapy, it'll be -- if it's effective, you'll find that it increases costs. And when that happens, you calculate as the ICER group did, you calculate what's called an incremental cost effectiveness ratio, which is generally measured in cost per quality adjusted life year gained. You don't calculate that ratio for technical reasons, you don't calculate that ratio when you have improved outcome at lower cost, improved the outcome at lower cost is called dominant. And our analysis strongly suggests that we have a dominant strategy here that has improved the outcome at low cost.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [45]
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So really, a dominant strategy today in the U.S. health care system would be what would be a fully integrated payer where they're actually paying for and bearing all of the risk, including not only the drug cost, but also the downstream bad outcomes, which is the hospitalization costs as well as the provider costs and all of the other downstream implications of the disease.
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William Weintraub, [46]
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Now what we aim at is a societal study in which we reflect everything across society, that's almost impossible to do because you can't make those pull of those measurements. So we use various proxies to allow you to get at that. But your point is this is looking broadly rather than just considering a hospital or a doctor's office or something, or something like that. So we're trying -- we aim to look as broadly across the society as we can.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [47]
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Right. And I think in our U.S. system, there are very few groups that really are tasked with or have that obligation, look at total costs. So I think probably, if the health care system is changing over time. There are more and more of those that will be both bearing the risk of all the costs as well as the economic potential gains of being able to deliver care below that cost threshold, whatever that is, whether they're reimbursed.
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William Weintraub, [48]
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Yes, that's very true. But people who do cost-effectiveness analysis, this is not uncommon for people to attempt to think as broadly as we can. But I think more and more as we consider health care economics, people are going to expect that we will own broadly.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [49]
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Now that's all very, very helpful context of this. When you said that some of the differences are subtle between the different models, what are the things that the model is most sensitive to?
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William Weintraub, [50]
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Right. So that's very important. It's most sensitive to the cost of the pharmaceutical -- there's very little difference between what we did and what the ICER did. They use SSR costs, we use SSR costs. The real difficulty is the cost of events, and there's uncertainty about what a hospitalization for heart attack or stroke for cardiac catheterization for percutaneous coronary intervention or coronary surgery costs. And because of that, that could have a big effect on the results of the analysis. And we were very sensitive to that, we'll be looking to that in very great detail.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [51]
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Now U.S. also had a unique asset that probably has not been made available very often before from commercial payers, you might want to just comment a bit on that and why those costs might be much more reflective of what is actually being paid in the real world.
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William Weintraub, [52]
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So I'm not sure what you're referring to.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [53]
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Well, you had some of the real commercial costs as opposed to the projected cost?
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William Weintraub, [54]
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Yes. Right. So you're thinking about the cost from the Optum Group?
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [55]
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Exactly.
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William Weintraub, [56]
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So Optum looks broadly across payers in the United States. And this is a huge database of -- I don't remember the exact number. But it's on the order of 160 million people in this database, broadly across payers, allowing what we believe is actually a far more accurate assessment of costs than Medicare costs. I think that people recognize that Medicare costs really do not cover the cost of events. And so if you use Medicare cost alone, you're going to underestimate the value of prevention. And so I think that's very important for people to come to understand looking at cost-effective analysis that we have to work hard to fund the best estimates of cost. And so that we can appropriately evaluate the value of the therapies that we all paid for patients.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [57]
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And since you had the patient level data, those that were less than 65 years old were not yet in Medicare, you actually use the true commercial costs. And for those that are over 65, you use the Medicare costs.
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William Weintraub, [58]
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Yes. We've done that. And I think that's relatively conservative analysis. But it can also be criticized. Well, you might say, "Oh, you should use the Optum costs for everybody." Well, what would happen then if you use Optum costs for everybody? If we think that really reflects real cost, then the finding of a dominant strategy for a cost being implemented would be strengthened even more?
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [59]
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All right. I think that's helpful context. I think these are some of the details and that are important in really trying to reflect reality what truly are the cost and risk of the global population in the U.S. group. And as you mentioned, and we'll turn it back over to Dr. Bhatt and the talk about the REDUCE-IT USA, but to look really in the U.S. population with U.S. costs might give results that are potentially different.
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William Weintraub, [60]
--------------------------------------------------------------------------------
So we have a subgroup analysis. We have not done this as thoroughly as we plan to in -- for the U.S., but our subgroup analysis suggests that the value of icosapent ethyl is going to be even more strengthened with -- for the U.S. patients.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [61]
--------------------------------------------------------------------------------
Thank you, Bill. I appreciate that. So Dr. Bhatt, I know that there was a tremendous amount of interest in doing the U.S. subgroup out of the study. What were the findings from that analysis?
--------------------------------------------------------------------------------
Deepak Bhatt, [62]
--------------------------------------------------------------------------------
So this was a prespecified subgroup. And the reason we were interested in looking at in the first place was to provide some context because there's a number of these large international trials, for whatever reason in the past, show results in the U.S., they're just different from the rest of the world, usually not looking as good. And then it's hard to know, is it just that it's a small subgroup, is it just a spurious finding. But then the American physician is left in the challenging position of a trial where the data might look good, but then in the wrong country, it doesn't look that good. So that was the basis for prespecifying this and the scientific rationale. So we did go ahead with this. And of course, the timing of this analysis is useful as U.S. regulators and other physicians in the U.S. are considering how to apply the data in the U.S. But the analysis itself was prespecified. So the overall results, first, let me say, for both within the U.S. and outside the U.S. look spectacular. That is for the primary efficacy endpoint, the key secondary efficacy endpoint in both cases, both within the U.S., but also in the subgroup of non-U. S. patients, both of these are statistically significantly reduced. So I don't want to create the impression that the drug is working in the U.S. and working only in the U.S. That would be a mistake. So hopefully no one walks away with that impression. The drug works globally in all the regions we studied, and there's no reason to think it wouldn't work in the regions where we didn't include patients.
Now what we found in our U.S. subgroup analysis was for the primary and key sector endpoint, results that were at least as robust, at least as large in magnitude as in the overall trial. And then on top of that, for the endpoint of all-cause mortality, a significant 30% reduction in death in the U.S. as well as that translated to a 2.6% absolute risk reduction mortality. So that is really upping the ante, so to speak, we're showing not just reductions in things like heart attack and stroke, that's pretty good and good enough, but also now showing a reduction in dying.
--------------------------------------------------------------------------------
Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [63]
--------------------------------------------------------------------------------
Now I know the paper had a, what I would call an exhaustive review in one of the supplemental tables of all of the differences in the population. It might be very helpful for you with your clinical judgment and sort of deep immersion in the database over the last year, and maybe pick out those criteria of the U.S. subgroup that was different than the non-U. S. subgroup.
--------------------------------------------------------------------------------
Deepak Bhatt, [64]
--------------------------------------------------------------------------------
It's a great question because, again, I wouldn't want anyone in the audience walking away thinking, "Oh, the drug is, for some reason, magically just working in the U.S. and doesn't work as well outside the U.S." That's not true at all. It worked in all the populations we studied, whether it's the region, ethnicity, various other subgroups, the drug was consistent in its benefits. The reason I think the results look better in the U.S., and there's this reduction in mortality that's significant, and that the overall trial there was a trend towards a lower all-cause mortality. And mortality from cardiovascular causes and the overall trial was significantly reduced by 20%. But the reason, I think, we're seeing an amplification, you could say, a benefit in the U.S. subgroup isn't because there were people living in the U.S. per se, but rather, they had more risk factors. So I think a higher risk population, well, we saw more benefit and this is akin to what was observed in the statin literature, higher risk patients of the curves for events separate sooner, the degree of benefit is larger, but even in lower-risk patients with statins. If you follow them long enough, benefit emerges. So I think that's really the key that the U.S. patients were higher risk than the non-U. S. patients. And by higher risk, I mean, more obesity. For example, that's known from other studies, that's not a novel observation, there's more obesity in the U.S. in other regions of the world. That's unfortunate, but that's true. But there are other risk factors as well that were occurring with a higher degree of prevalence in the U.S. versus non-U. S. groups. But one other thing I'll mention, too, is that the EPA or eicosapentaenoic acid levels at baseline were a bit lower in the U.S. versus outside the U.S., so that might be another reason why it seems like the drug was performing even better than it did in the overall trial, where it performed quite well. I also want to point out, too, sometimes people have thought once they saw this data set that, "oh, maybe it's just -- there's a bunch more secondary prevention patients in the U.S.," that's really what's driving it. In fact, it's the opposite. There's a higher proportion of primary prevention patients from the U.S. So that's not what's driving it. It's just that there's more risk factors, a clustering of risk factors. So I think the take-home message isn't so much that all of the drug works there in the U.S., but rather, if you have higher risk patients, they derive even greater benefit, and that benefit kicks in sooner.
--------------------------------------------------------------------------------
Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [65]
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Right. And so I think you raised what to me was a really important finding. And I think there's a lot of confusion about primary and secondary prevention in high-risk and low-risk in this perception that primary prevention is low risk and secondary prevention is high risk. The results of the REDUCE-IT USA seemed to be somewhat at odds with that common understanding or perhaps common misunderstanding?
--------------------------------------------------------------------------------
Deepak Bhatt, [66]
--------------------------------------------------------------------------------
Yes. The truth is this is an outdated paradigm talking about artificial universes of primary prevention and secondary prevention. And so your existing in different areas. When in fact, there's a lot of overlap. And Dr. Budoff, for example, spends a lot of his day doing CT angiography, that is imaging of hard arteries. So what is someone who is asymptomatic, but for whatever reason, they end up getting a CT angiogram, and they've got a ton of plaque in their arteries. Is that a primary prevention patient? Or is that a secondary prevention patient? That nomenclature isn't set up to capture that patient. To me, if they've got a ton of plaque in their arteries, they're at high risk. They may not know they're at high risk, they may not have symptoms or sort of an early warning system, where they're having chest pain or anything. To me, that's almost more dangerous. I'd rather have the secondary prevention patient who has stable angina. It knows when he or she's running to the bus and they're having chest pain, they stop running. But it's that asymptomatic patient, in many respects, is scarier because you don't really know what to do to reduce their risk. So it's an artificial classification. For the purposes of doing clinical trials, we enroll a bunch of different types of patients. We sort of guesstimate what their event rates might be so that we can do a trial with a particular drug or device in a finite period of time with a finite sample size. So it's a bit artificial. What we've shown in REDUCE-IT is across a variety of risk, the patients benefit substantially for icosapent ethyl.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [67]
--------------------------------------------------------------------------------
Yes. And I think, Matt, there's both a trial list, but also participating center in REDUCE-IT. I mean, what are your thoughts on this whole issue of primary prevention and secondary prevention? And when you think about the EVAPORATE study? Do you have both types of patients in EVAPORATE?
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Matthew Budoff, [68]
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Yes. No, I think as Dr. Bhatt already mentioned, they're not perfectly captured the way that we think of it today, but I always think of patients with a lot of atherosclerosis has, at least, what we call a secondary risk equivalent. In other words, we might not -- the guidelines may not quite put them into the secondary prevention bucket, but we treat them as aggressively as that group. And I think that's something else where EVAPORATE, I think, will help some clinicians. We're getting a lot of patients in the U.S. getting calcium scoring, which is another CT-based way of measuring risk, and we're getting a lot of patients getting CT angiography now for different reasons. And if you have a tool or a treatment that will actually help reduce the plaque burden that they see, that's yet -- going to be in their clinical eyes. Another indication to use this therapy is they use it -- I see a lot of plaque. I know this slows down plaque, I'm going to use this therapy. And we don't have that many therapies that have this level of evidence now.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [69]
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And regardless of whether it's primary prevention or secondary prevention. I guess, the guidelines have also tried to move away from some of these hard and fast benchmarks or numerically based thresholds. And perhaps, Dr. Bhatt, you could comment first on that, and maybe you, Dr. Budoff, on this sort of movement of the guideline to risk characterizations as opposed to primary prevention or secondary prevention around an arbitrary pivot?
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Deepak Bhatt, [70]
--------------------------------------------------------------------------------
Yes. Things are really changing the guidelines, as Dr. Budoff alluded to, in terms of risk stratification, even in terms of allocating statin therapy in the primary prevention world. Now we're saying, "Yes, you can use coronary calcium. It can be quite useful figure out who really does benefit from being in that group receiving statin therapy." So there's really an evolution in our thinking in terms of what those terms primary and secondary prevention mean. And I think the use of coronary calcium and to seek angiography in general is really poised to boom in this country. For a variety of different reasons, guideline related to non-guideline related. A lot of it's patient driven. Patients want to know, is there a trouble brewing in their coronary arteries. Is their plaque that's built up, and I think that will make these terms of primary and secondary prevention even more obsolete. The issue is, is a person at risk? That's the real issue. And you might define that by biomarkers, such as LDL elevation in terms of statin allocation, in terms of triglyceride elevation, in terms of consideration of icosapent ethyl. But on the other hand, you might move away from biomarker and say, "Oh, look, there's plaque in the left main, that's a problem regardless what the biomarker show."
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [71]
--------------------------------------------------------------------------------
Yes. I mean, I think, Matt, also and just in closing, before turning it back over to Elizabeth. I mean as both a clinical trial list, but really as a practicing physician, I think this, to me, is the science of medicine and the art of medicine, just like I think the EVAPORATE study is both the real hard-core science, but at the end of the day, it's about the outcomes, which is the quality of the science. Maybe you just want to comment a bit on that perspective with -- being a trial that's doing a lot of imaging. How do you sort of bring that into your discussion with patients in the context of primary prevention or secondary prevention?
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Matthew Budoff, [72]
--------------------------------------------------------------------------------
Yes. And I think it's really critical that people understand that whenever we put these buckets, the concept is primary prevention is lower risk and secondary prevention is higher risk. But what we're now seeing are high-risk primary prevention, which are really as high-risk as the other groups. So that's where I think we're starting to try to blur the lines as much as possible because as you said, it's one bad day. They had a heart attack, now they're secondary prevention. If they died of the heart attack, they never make it to secondary prevention, and we never treat them with these drugs that are only allocated to secondary prevention. It's too late to put the cholesterol pill under their tongue while we're doing CPR to try to get their cholesterol down. So we need better ways of identifying who's at risk of having a bad day in the near future. And we're going to turn to imaging. It's already happening. It's going to happen. I agree with Dr. Bhatt, I think it's going to happen faster, where we're going to want to take a look in our coronary arteries. And if they're all blocked up, we're going to be like, I'm high risk, I need to do things about it. And if we have tools that can help us either unblock the artery or lower our risk or do both, as I think we have evidence now with icosapent ethyl. I think that's going to be a therapy that doctors are going to turn to.
--------------------------------------------------------------------------------
Deepak Bhatt, [73]
--------------------------------------------------------------------------------
Yes, I agree. And even beyond just using imaging, there are still some simple clinical descriptors as if somebody has diabetes, essentially, that's an equivalent to someone that's had a prior heart attack, a number of observational and epidemiologic studies show that. So there are some things even without doing biomarkers or fancy imaging, you know that, that person is at risk.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [74]
--------------------------------------------------------------------------------
I think that's a great way to cap it because at the end, it really is about the individual interaction between the patient and the clinician about what's going to work best for them and work best in their life, no matter what the intervention is or not.
So I think with that, Elisabeth, did we cover many of the questions that you think are coming in?
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Elisabeth Schwartz, Amarin Corporation plc - Senior Director of IR [75]
--------------------------------------------------------------------------------
Yes, I think that was very helpful to put these results into context, and Craig, I want to thank you for leading this discussion today. Dr. Budoff, Dr. Bhatt, Dr. Weintraub, I'd like to thank you for being with us today, and I very much appreciate the contributions you're making to medical science.
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Craig B. Granowitz, Amarin Corporation plc - Chief Medical Officer & Senior VP [76]
--------------------------------------------------------------------------------
Thank you.
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Elisabeth Schwartz, Amarin Corporation plc - Senior Director of IR [77]
--------------------------------------------------------------------------------
Thank you.
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Operator [78]
--------------------------------------------------------------------------------
This concludes today's teleconference. You may now disconnect your lines at this time. Thank you for your participation, and have a wonderful day.
Amarin Highlights Key REDUCE-IT®-Related Data Presented at American Heart Association 2019 Scientific Sessions
https://investor.amarincorp.com/news-releases/news-release-details/amarin-highlights-key-reduce-itr-related-data-presented-american
MO
Can’t believe they played the MO card for more than a year and manipulated the stock so much while bottom line, it’s a non-issue and MO is officially dead
Where is the SEC in all of this, those so called analyst coverage with 0 background in biology, science, medicine....AF, MH, Cramer, The Street & Cramer’s website should all be investigated along with their under the table funds and short sharks
EVAPORATE Study
Demonstrated that placebo progression rates using mineral oil is similar to non-mineral oil (cellulose) using same methodology, scanner and laboratory in a matched cohort
1.15 million shares traded pre-market and still 45 minute for market open.
mmmmmmm are shorts in panic mode??
numbers says yup they are :):)
What i love about all these equity coverage and PT is that none of them are including the potential revenue generated from outside US. You have Canada, China, Middle East, Soon Europe, and most definitely Latin America will be included soon.
All of these markets will be paying up front payments and double digit royalties and some are bigger markets than the US, so imagine the PT when all these are included.
As always, ihub is way ahead of those called analysts and that's why we benefit the most from our position and exposure from sub $1 till ..... i would say triple digits numbers in few years
Citi New PT $27 from $23
(i don't understand their downgrade to Neutral but a RAISE in PT)
Citi downgraded Amarin Corporation (AMRN) to Neutral and target $27
Citi downgraded Amarin Corporation (AMRN) to Neutral and target $27
Past Rating: Buy
Past Target Price: $23
Another issue,
I have a feeling that some firms and crooks will try to come out with their own twist that AMRN will not get the label it requested and try to put pressure to help their short positions and friends, volatility will be there in the stock, but derisking is on and no matter what, this will go upwards in the future and the sky is the limit
Dear all,
I wasn't able to post last night after i reached my limit.
Congrats to all
Anyhow, what a day, up and down with all discussions but finally science prevailed and we got our 16-0 vote
In addition with regard to primary indication, i would say panelists were 10 for - 4 against & 2 undecided (10-4-2) and that bodes well for us.
Personally, and after watching and listening to all panelists after the vote, i would say we will get a label for both primary & secondary, TG 150 and above, 40 Years onward & of course diabetic and with one or more CVD risk factors.
And as with statins, the prerequisites with time will be loosened after Real World Data & follow up
Finally, and all my personal opinion, i am strongly against a BO. Why burn your cards and miss opportunities for your shareholders by taking a premium NOW of 100% - 200% (based on Wednesday close of $21.49) when in the future (2021-2022) your company will be generating billions if not tens of billions of income and your valuation will be at the level on its own and then you can decide to get a premium on top of that or remain an independent big firm just like others.
Congrats to all once again and let's enjoy 2020 and more
NORMALIZED Scripts Update for Week Ending 08/11
ATH in TRx & Refills Numbers & Market Share
2nd ATH in NRx Numbers & 3rd ATH in NRx Market Share
V
TRx: 75,757 {vs 73,771; +2.69%} Sector +2.36% --- (9,090,875 vs 8,852,522) --- ATH
NRx: 34,382 {vs 34,340; +0.12%} Sector +0.89% --- (4,125,792 vs 4,120,781) --- 2nd ATH {ATH=34,405}
Ref: 41,376 {vs 39,431; +4.93%} Sector +3.65% --- (4,965,083 vs 4,731,741) --- ATH
GenL
TRx: 62,303 {vs 60,978; +2.17%} (7,476,231 vs 7,317,309)
NRx: 29,238 {vs 28,668; +1.99%} (3,508,524 vs 3,440,183)
L
TRx: 890 {vs 999; -10.91%} (106,848 vs 119,934)
NRx: 386 {vs 434; -11.22%} (46,282 vs 52,132)
V TRx Market Share: 54.52% vs 54.34% --- ATH
V NRx Market Share: 53.72% vs 54.13% --- 3rd ATH
V Ref Market Share: 55.21% vs 54.53% --- ATH
For those interested in Old Scripts Numbers ATH Across the Board in Numbers & Market Share (except NRx Market Share 3rd ATH);
V TRx 58,223 vs GL TRx 46,662 & L 640 -- ATH
V NRx 22,434 vs GL NRx 19,468 & L 228 -- ATH
V Refills 35,789 vs GL Refills 27,194 & L 412 -- ATH
Dr. James de lamos again primary prevention so far
Love that they surpassed the boundaries in interms, but didn’t stop
Update pls
Feed gone on 2 screens
Lost it totally
F u ,,k that sh .,.t
Audio sucks. Cutting and freezing
Majority*
So far major public speakers on our side
Yup I am
RAF,
ur in the room, any updates on the mood, vibes of the members, dr Bhatt and Amarin people?
ADCOM webcast, rooms are full. Can anyone post it live on YouTube? So we can watch. Was disconnected and when trying to log in, rooms are full
Safety review
Benefit risk profile remains favorable
Efficacy review
Significant efficient results
2nd FDA guy, positive for V
FDA
Median ldl-c change due to MO can be translated to roughly 3% change in placebo group
Not important and effective and doesn’t change AMR101 realized effect
RAF RE: THERO SALE
He just sold 41,741 out of 433,805 acquired. Only 10%
FDA Briefing Documents
“The increased incidence of AF in REDUCE-IT is a concerning safety signal, especially in the intended population with elevated baseline risk for AF. A similar signal was observed in the Kowey 2010 trial with Lovaza, albeit in a different population.
Given the strength and consistency of the finding of reduction of major adverse cardiovascular events in REDUCE-IT, the benefit-risk assessment favors the use of Vascepa for CVD risk reduction in the intended population with caution regarding a potential increase in risk of AF.”
13F
ARTISAN PARTNERS LIMITED PARTNERSHIP AMRN: Increased position: 12,982,428 Shares
Any idea who they are?
MINERAL OIL DONE DEAL
FROM FDA BRIEFING DOCUMENT
"FDA analyses attempting to differentiate whether increases in LDL-C and other biomarkers were
due to the mineral oil placebo are inconclusive. Due to lack of certain key measurements, we
could neither rule out the possibility that mineral oil – at least to some extent – interfered with
statin absorption nor estimate the magnitude of LDL-C or other biomarker increase that could
be attributed to such an interaction. From the scientific perspective, therefore, it remains
necessary to consider what impact the increase in LDL-C and other biomarkers had on CV
outcomes. The most sensitive approach to assess these possible effects was to consider the
worst-case, that the entire difference between treatment arms was due to mineral oil. FDA’s
exploratory analyses to assess the effect of these markers suggested that the difference in LDLC between the study groups could not account for the positive CV outcomes."
Finally, although there is less plausibility for an interaction between mineral oil and other
background cardiovascular medications with known CV benefits (antihypertensives, antiplatelet
agents, and anticoagulant medications), we considered whether trial data indicated any effects
on these drugs that might further impact the observed effect of AMR101 on outcomes. We
concluded that these analyses showed no evidence of such a signal.
Thank you in advance for your participation in the discussion of these important considerations.
We look forward to the discussion and advice as we consider the potential approval of Vascepa
for a new cardiovascular risk reduction indication.
ADCOM QUESTION ONNNNN
DISCUSSION: Please discuss your interpretation of the efficacy results from the REDUCEIT Trial, including the following:
a. Overall strengths and limitations of the data, including the use of a single trial to
support a first-in-class cardiovascular outcomes indication and robustness of the
results
b. Confidence in the trial outcomes when considering the mineral oil placebo
c. Magnitude/clinical relevance of the observed treatment effect
d. Components of the primary composite endpoint or secondary endpoints, including the
robustness of the data to support an indication for CV death
2. DISCUSSION: Please discuss your level of concern about the new safety findings (increased
risk of atrial fibrillation/atrial flutter and bleedings events) from the REDUCE-IT trial and
whether labeling can reasonably manage these risks.
3. DISCUSSION: The applicant has proposed an indication for cardiovascular risk reduction in
adult patients with triglyceride levels greater than 135 mg/dL and additional risk factors for
cardiovascular disease (CVD), without regard for age, diabetes status, or adequacy of lowdensity lipoprotein (LDL-C) control. Please discuss the population – beyond the subset of
patients with established CVD – for whom you believe the data from REDUCE-IT provide
evidence of cardiovascular risk benefit, addressing the following factors:
• Age
• Diagnosis of diabetes
• Additional risk factors for CVD
• Plasma LDL-C concentration
• Plasma triglyceride concentration
• Intensity of statin therapy
• Any other factor you believe is important
4. VOTE: Has the applicant provided sufficient evidence of efficacy and safety to support the
approval of Vascepa for an indication to reduce the risk of cardiovascular events?
a. If yes, provide your recommendations regarding the indicated population and
components of the primary endpoint to include in labeling.
b. If no, provide your rationale and comment on what additional data would be needed to
support approval.
October-2019 vs. October-2018 NORMALIZED Retail ONLY Data
Amazing Year-On-Year Increase Across the Board; 84% increase in TRx & 82% increase in NRx & 85% increase in Refills
It is worth mentioning that V is driving the whole sector into positive green territory (Year-On-Year ~+20% TRx & ~+23% NRx & ~+11% Refills) and at the same time increasing its own Market Share
V
TRx: 326,711 {vs 177,642; +83.92%} – Sector +19.59% -- ATH
NRx: 152,705 {vs 83,782; +82.26%} – Sector +22.87% -- ATH
Ref: 174,006 {vs 93,860; +85.39%} – Sector +10.81% -- ATH
Gen L
TRx: 275,151 {vs 322,341; -14.64%}
NRx: 130,511 {vs 146,696; -11.03%}
L
TRx: 4,282 {vs 6,871; -37.68%}
NRx: 1,733 {vs 2,825; -38.65%}
V October-2019 NORMALIZED Retail ONLY TRx Market Share: 53.90% vs 35.05% in October-2018 --- ATH
V October-2019 NORMALIZED Retail ONLY NRx Market Share: 53.59% vs 35.91% in October-2018 --- ATH
V October-2019 NORMALIZED Retail ONLY Ref Market Share: 54.17% vs 34.31% in October-2018 --- ATH
Total Monthly NORMALIZED Retail ONLY Data October-2019
Q4-2019 STARTS WITH A BANG
ATH Across the Board in Numbers & Market Share
V
TRx: 326,711 {vs 293,311; +11.39%} – Sector +9.15% -- ATH (39,205,289 vs 35,197,312)
NRx: 152,705 {vs 134,073; +13.90%} – Sector +11.41% -- ATH (18,324,581 vs 16,088,753)
Ref: 174,006 {vs 159,238; +9.27%} – Sector +7.23% -- ATH (20,880,708 vs 19,108,559)
Gen L
TRx: 275,151 {vs 257,848; +6.71%} (33,018,135 vs 30,941,803)
NRx: 130,511 {vs 120,098; +8.67%} (15,661,364 vs 14,411,770)
L
TRx: 4,282 {vs 4,146; +3.27%} (513,823 vs 497,546)
NRx: 1,733 {vs 1,590; +8.99%} (207,993 vs 190,839)
Monthly NORMALIZED Retail TRx Market Share: 53.90% vs 52.82% --- ATH
Monthly NORMALIZED Retail NRx Market Share: 53.59% vs 52.42% --- ATH
Monthly NORMALIZED Retail Refills Market Share: 54.17% vs 53.16% --- ATH
For those interested in Old Scripts Numbers ATH Across the Board in Market Share & Refills Numbers
V TRx 249,643 vs GL TRx 207,208 & L 2,848 -- ATH
V NRx 99,697 vs GL NRx 87,228 & L 1,028 -- ATH
V Refills 149,946 vs GL Refills 119,980 & L 1,820 -- ATH
NORMALIZED Scripts Update for Week Ending 01/11
2nd ATH Across the Board in Numbers
ATH in NRx Market Share & 2nd ATH in TRx & Refills Market Share
V
TRx: 73,771 {vs 73,930; -0.22%} Sector +0.07% --- (8,852,522 vs 8,871,654) --- 2nd ATH
NRx: 34,340 {vs 34,405; -0.19%} Sector -0.34% --- (4,120,781 vs 4,128,616) --- 2nd ATH
Ref: 39,431 {vs 39,525; -0.24%} Sector +0.43% --- (4,731,741 vs 4,743,038) --- 2nd ATH
GenL
TRx: 60,978 {vs 60,872; +0.17%} (7,317,309 vs 7,304,660)
NRx: 28,668 {vs 28,910; -0.84%} (3,440,183 vs 3,469,153)
L
TRx: 999 {vs 853; +17.13%} (119,934 vs 102,395)
NRx: 434 {vs 342; +27.10%} (52,132 vs 41,016)
V TRx Market Share: 54.34% vs 54.50% --- 2nd ATH
V NRx Market Share: 54.13% vs 54.05% --- ATH
V Ref Market Share: 54.53% vs 54.90% --- 2nd ATH
For those interested in Old Scripts Numbers ATH Across the Board in Numbers & Market Share (except NRx Numbers 2nd ATH);
V TRx 56,530 vs GL TRx 45,842 & L 644 -- ATH
V NRx 22,347 vs GL NRx 19,145 & L 259 -- 2nd ATH
V Refills 34,183 vs GL Refills 26,697 & L 385 -- ATH
10-Q ADCOM INFORMATION
Based on our current understanding of FDA’s focus and perspectives due in part to our review of an advanced copy of a draft of FDA’s EMDAC briefing document received from FDA at the end of October 2019 as part of the agency’s typical procedures, we expect the final FDA EMDAC briefing document and the EMDAC meeting to cover the following topics, among others, related to our REDUCE-IT sNDA, which topics are among the broad range of topics typically explored at FDA advisory committee meetings and cover matters consistent with prior disclosures and available data:
•
analyses of the degree of treatment benefit in the different patient populations (i.e., subgroups) studied in REDUCE-IT and the sufficiency of the efficacy findings to support indications and the appropriate wording thereof in light of the patient characteristics of the populations studied; for example, as prespecified and previously disclosed, the established cardiovascular (CVD) disease secondary prevention cohort, which represented approximately 70% of enrolled patients in REDUCE-IT and had a high observed event rate, experienced a numerically higher effect size (27% relative risk reduction, or RRR) than the high-risk, mostly diabetic primary prevention cohort, which represented approximately 30% of enrolled patients and had a relatively lower observed event rate and experienced a 12% RRR;
•
analyses of the degree of treatment benefit on specific studied endpoints in the different subgroups studied in REDUCE-IT and the sufficiency of the efficacy findings with respect to the studied endpoints to support indications and the appropriate wording thereof; for example, as previously disclosed, beyond the primary endpoint and key secondary endpoint, seven secondary endpoints of different clinical relevance were achieved to varying degrees of impact and degrees of statistical significance in the order of sequential statistical testing within the prespecified hierarchy;
•
analyses related to study conduct and data robustness, quality, integrity and consistency; for example, as previously disclosed, REDUCE-IT was a single clinical trial conducted based on a special protocol assessment (SPA) agreement with the FDA and, as is typical for all CV outcomes studies, related analyses are expected on the overall strength and limitations of study data to support the indications sought, as described above, considering factors including, but not limited to, the use of mineral oil placebo used in the study and questions explored in past FDA reviews and raised publicly since then over the plausibility of an interaction of the placebo with statins that some have argued could have led to reduced absorption of statin medications, which we do not believe occurred for reasons previously disclosed, among
39
others to be presented in our briefing document; but, consistent with the publication of REDUCE-IT results in The New England Journal of Medicine, we believe FDA has assessed that even if plausible based on indirect evidence of a potential effect, that an exploratory analysis indicates the effect, if any, of mineral oil on LDL cholesterol values on the time to the primary endpoint is numerically small and unlikely to change the overall conclusion of treatment benefit (see also, the previously disclosed discussion of mineral oil placebo below within, “---Clinical trials that we or potential partners conduct, including the REDUCE-IT trial, may not provide sufficient safety and efficacy data to obtain the requisite regulatory approvals for product candidates or to achieve a level of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary for commercial success if we obtain regulatory approval”);
•
safety data and related risk/benefit considerations in light of the above; for example, as previously disclosed, overall safety findings in REDUCE-IT were generally consistent with product labeling and available data on the omega-3 class; more patients in the Vascepa group experienced an adjudicated event of atrial fibrillation or atrial flutter event requiring hospitalization 24 hours or greater compared with patients in the placebo group (3.1% versus 2.1%), and more patients experienced any treatment emergent adverse event of atrial fibrillation or atrial flutter in the Vascepa arm versus placebo; the incidence of atrial fibrillation or atrial flutter was greater in the subset of patients with a previous history of atrial fibrillation or flutter, and the relative imbalance was numerically greater between arms in this subgroup compared with the imbalance in those without a previous history; additionally, more patients in the Vascepa group experienced an adverse event of bleeding compared with patients in the placebo group, excluding hemorrhagic strokes (which were adjudicated efficacy events), 482 patients (11.8%) in the Vascepa treatment arm experienced bleeding events compared to 404 patients (9.9%) in the placebo treatment arm (in each case, consistent with prior disclosures); and
•
Consideration of REDUCE-IT results in the context of other clinical studies.
AMARIN NUMBERS FOR YEAR 2019
Below my small due diligence about results.
I think we will easily beat $420million if the % increase Q vs Q is intact
Q1-2018 $43.8 million /// Q1-2019 $73.3 million ---> +67%
Q2-2018 $52.5 million /// Q2-2019 $100.8 million ---> +92%
Q3-2018 $55 million /// Q3-2019 $112.3 million ---> +104%
Q4-2018 $77.1 million /// Q4-2019 $xxx million ---> +xx%
Q2-2018 vs Q1-2018 +20% // Q2-2019 vs Q1-2019 +37.5%
Q3-2018 vs Q2-2018 +5% // Q3-2019 vs Q2-2019 +11%
Q4-2018 vs Q3-2018 +40% // Q4-2019 vs Q3-2019 +xx%
Let's assume the increase ain't a multiple as previous quarter comparison 2019 vs 2018.
Let's assume that the Q4-2019 vs Q3-2019 is half the one seen in 2018, so we are talking of an increase of just 20% --> Q4-2019 = $134.8 million
Making Year-2019 total of $421.2 million
I would say that the % increase in Q4 will be around 30% - 40% --> Q4 ~ $151.6 million --> Year-2019 = $438 million
In my personal opinion, Amarin will close Year-2019 > $430 million
Net cash flows, excluding net proceeds from the equity offering completed in the third quarter of 2019, was positive $11.3 million
Based on data, if all patients in the United States who have risk profiles similar to what was studied in REDUCE-IT were to take Vascepa, this could lower the number of major adverse cardiovascular events in the United States by approximately 150,000 to 450,000 per year.
Preparing for anticipated label expansion: Assuming that, on or before the previously announced December 28, 2019 PDUFA date
Amarin Reports Third Quarter 2019 Financial Results and Provides Update on Operations
For best results when printing this announcement, please click on link below:
http://pdf.reuters.com/htmlnews/htmlnews.asp?i=43059c3bf0e37541&u=urn:newsml:reuters.com:20191105:nGNX42c9mG
Record Revenue Levels and Preparations On-Track for Further Expansion
Management to Host Conference Call at 7:30 a.m. ET Today
DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 05, 2019 (GLOBE NEWSWIRE) --
Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company focused on
improving cardiovascular health, today announced financial results for the
three and nine months ended September 30, 2019 and provided an update on
company operations.
Key Amarin achievements since its last quarterly report include:
* Record total revenue: Reported total revenue of $112.4 million and $286.5
million for the three and nine months ended September 30, 2019, respectively,
representing increases of 103% and 89%, respectively, over the corresponding
periods of the prior year. The total revenue reported for the first nine
months of 2019 exceeded the full-year results reported for 2018.
* Record prescriptions: Growth in net product revenue was supported by
increased prescription levels of Vascepa® (icosapent ethyl) capsules. The
increased prescription levels reflect both a higher number of Vascepa
prescribers and an increase in the average prescriptions per prescriber.
* Preparing for anticipated label expansion: Assuming that, on or before the
previously announced December 28, 2019 PDUFA date, Vascepa’s label will be
expanded to reflect cardiovascular risk reduction as demonstrated in the
REDUCE-IT® cardiovascular outcomes study, Amarin is taking broad steps to
prepare for commercialization of Vascepa as the first therapy to address this
important unmet medical need, including preparation for increased education of
healthcare professionals and patients. Furthermore, to support FDA’s
approval of Vascepa for this expanded indication, Amarin has prepared for, and
looks forward to, the FDA’s advisory committee meeting scheduled for
November 14, 2019.
* International regulatory activities on track: Amarin continues to target
making its submission, before the end of 2019, seeking regulatory approval of
Vascepa in Europe. Regulatory review of Vascepa in Canada continues to
progress through Amarin’s commercial partner in Canada with approval
anticipated near the end of 2019 (late 2019 or early 2020).
* Scientific advancement continues: Thus far in 2019, Amarin has supported
more than 40 scientific manuscripts or scientific publications with additional
presentations anticipated before year-end, including multiple presentations
later this month at the American Heart Associations’ Annual Scientific
Sessions.
* Medical community support for using Vascepa to help patients: Following the
American Diabetes Association (ADA) new medical guidelines issued in March
2019, leading cardiology, endocrinology and lipidology societies have updated
their clinical guidelines or provided varying other forms of advisories that
reflect the results of the REDUCE-IT study for patients who despite
well-controlled LDL-cholesterol have elevated triglyceride levels (>135 mg/dL)
and other cardiovascular risk factors. In Amarin’s view, it is extraordinary
to witness this broad level of medical society support prior to FDA approval
for this important medical indication. These societies include the National
Lipid Association, American Heart Association, European Society of Cardiology
and the European Atherosclerosis Society. Separately, an independent drug
pricing watchdog group concluded that Vascepa is cost effective for
cardiovascular risk reduction even under the most stringent standards of that
group, which is rarely achieved in their analysis.
“Our aim is to help as many patients as possible with Vascepa.
Accordingly, we are pleased to witness the growth in Vascepa usage as reported
in the third quarter. These recent results are laying the foundation for our
future growth as we seek to make Vascepa a new standard of care for use in
appropriate at-risk patient populations based on REDUCE-IT,” stated John F.
Thero, president and chief executive officer. “We are appreciative of the
many patients and health care professionals who have reached out to us
expressing support for approval of Vascepa for the expanded indication being
sought. We are working with leading physicians to ensure that the results of
the landmark REDUCE-IT study are well understood by regulatory authorities and
their advisors. We recognize that much work remains following the anticipated
approval of Vascepa. We remain guided by science and highly motivated by the
unmet medical need that we believe Vascepa can address.”
Prescription Growth
Based on monthly compilations of data provided by third parties, Symphony
Health and IQVIA, the estimated number of normalized total Vascepa
prescriptions for the three months ended September 30, 2019 were
approximately 865,000 and 787,000, respectively, compared to 458,000 and
417,000, respectively, in the three months ended September 30, 2018. These
estimates reflect increases of 89% in the third quarter of 2019 over the same
period of 2018.
The increase in prescriptions occurred broadly across the United States with
the fastest percentage growth reported to come from cardiologists and
endocrinologists and with the largest overall volume growth coming from
general practitioners as there are many more general practitioners than
specialists in the United States. The growth came from areas supported by
Amarin’s legacy sales representatives and from faster than expected
productivity of new sales representatives added in early 2019. It is this
increased productivity of new sales representatives, together with feedback
from physicians, that convinced Amarin that the size of its sales force should
be doubled from 400 sales representatives (the level at which the company has
operated for most of 2019) to 800 sales representatives in preparation for the
launch of Vascepa for cardiovascular risk reduction at the start of 2020,
assuming FDA approval.
Regulatory Schedule in the United States
December 28, 2019 is the Prescription Drug User Fee Act (PDUFA) target date
for action on Amarin’s supplemental New Drug Application (sNDA) seeking
approval of Vascepa as the first drug approved for cardiovascular risk
reduction in the patient population studied in REDUCE-IT. An FDA advisory
committee meeting pertaining to the sNDA for Vascepa is scheduled to be held
on November 14, 2019 at the FDA’s offices in White Oak, Maryland. The FDA
makes information available regarding this advisory meeting at
https://www.fda.gov/advisory-committees/november-14-2019-meeting-endocrinologic-and-metabolic-drugs-advisory-committee-meeting-announcement.
Holding an advisory committee meeting in conjunction with its evaluation of a
new drug is not uncommon for the FDA, particularly when the indication being
sought is first in class for a potentially large patient population as is true
for the sNDA under review for Vascepa.
As is the usual protocol, briefing books will be used for preparation of
advisory committee panel members with information related to Vascepa, the
related science and questions that the advisory committee panel members will
be asked to vote on at the meeting. The briefing books typically are made
public two days before the commencement of the advisory committee meeting. We
expect this process to be no different for the Vascepa-related advisory
committee meeting on November 14, 2019. Advisory committee panel members may
ask their own questions regardless of whether such questions are covered in
the briefing books or not.
The results of the REDUCE-IT study have been published in The New England
Journal of Medicine and the Journal of the American College of Cardiology.
And, as noted above, leading medical societies and other groups support the
use of Vascepa to cost effectively address cardiovascular risk in studied at
risk patients beyond statin therapy. Based on data, if all patients in the
United States who have risk profiles similar to what was studied in REDUCE-IT
were to take Vascepa, this could lower the number of major adverse
cardiovascular events in the United States by approximately 150,000 to 450,000
per year.
Amarin looks forward to the advisory committee meeting on November 14, 2019 as
an opportunity to further illuminate the results of the REDUCE-IT study and to
provide further education on why Vascepa is a unique drug that should be
approved for cardiovascular risk reduction which would position the drug to
potentially help millions of patients. Amarin is appreciative of the
approximately 100 letters which have been sent to the FDA from health care
professionals, patients and others in support of prompt approval of Vascepa
for cardiovascular risk reduction. The letters can be viewed with this link:
https://bit.ly/36ypKev.
Commercial Growth
As previously described, upon Amarin’s anticipated FDA approval of an
expanded indication for Vascepa, Amarin’s goal is to launch a robust
educational and promotional campaign aimed at healthcare professionals and
consumers regarding the efficacy and safety profile of Vascepa as well as on
the significant unmet need to help patients with underlying cardiovascular
risks beyond cholesterol management.
One important element of the robust launch Amarin is planning is an expanded
sales team. The nucleus of Amarin’s sales team is experienced and productive
and has experienced limited turnover. Amarin’s sales representatives enjoy
helping healthcare professionals learn about new treatment options for their
patients. As noted above, Amarin intends to increase the size of the Amarin
direct sales team to approximately 800 sales representatives for the start of
2020. Amarin has received over 10,000 resumes for the 400 sales
representatives Amarin seeks to hire. While Amarin has hired some additional
sales representatives, Amarin’s plan is to hire most of the additional sales
representatives near the end of this year to support a launch of Vascepa, if
approved, after the December 28, 2019 PDUFA date. The larger sales team is
expected to educate a larger number of healthcare professionals and have more
frequent interactions with targeted healthcare professionals. The increased
sales force size is expected to reach approximately 70,000 to 80,000
healthcare professionals. Most of the sales management needed to support this
expansion has been hired or internally promoted and support systems are in
place with ample capacity to support this expansion.
Amarin reiterates its net revenue guidance for 2019 of $380 million to $420
million. Amarin does not plan to issue quantified 2020 guidance until after it
knows the details of the label for Vascepa following the PDUFA date.
Financial Update
Amarin recorded net product revenue of $112.3 million and $285.3 million
during the three and nine months ended September 30, 2019, respectively,
compared to $55.0 million and $151.3 million in the corresponding periods of
2018, respectively, representing increases of 104% and 89%, respectively. This
increase in net product revenue was driven primarily by an increase in
estimated normalized total Vascepa prescriptions in the United States.
Net pricing of Vascepa in the third quarter of 2019 was relatively consistent
with the prior year and channel inventory levels were in the ordinary range at
the beginning and end of the period.
Licensing revenue during the nine months ended September 30, 2019 and 2018
were $1.1 million and $0.6 million, respectively.
Gross margin on net product revenue for the three and nine months ended
September 30, 2019 were 77% compared to 75% and 76%, respectively, in the same
periods of 2018.
Selling, general and administrative (SG&A) expense for the three and nine
months ended September 30, 2019 were $82.6 million and $227.6 million,
respectively, compared to $50.0 million and $147.3 million, respectively, in
the corresponding periods of 2018, representing increases of 65% and 55%.
These increases in SG&A expense were due primarily to increased commercial and
other promotional costs for expansion following successful REDUCE-IT results
(announced on September 24, 2018), including sales force expansion costs,
partially offset by agreeing not to extend beyond December 31, 2018 the
company’s previous co-promotion agreement for Vascepa.
Research and development (R&D) expense for the three and nine months ended
September 30, 2019 were $8.9 million and $23.3 million, respectively, compared
to $14.1 million and $44.0 million, respectively, in the corresponding periods
of 2018, representing decreases of 37% and 47%, respectively. These decreases
in R&D expense is attributed to the decline in REDUCE-IT related costs
following presentation of such results in November 2018.
Under U.S. GAAP, Amarin reported net losses of $3.5 million and $29.7 million
in the three and nine months ended September 30, 2019, or basic and diluted
loss per share of $0.01 and $0.09, respectively, compared to net losses of
$24.5 million and $82.8 million in the corresponding periods of 2018, or basic
and diluted per share of $0.08 and $0.28, respectively. The net losses
included $8.0 million and $22.7 million in non-cash stock-based compensation
expense in the three and nine months ended September 30, 2019 compared to $6.7
million and $14.0 million in the corresponding periods of 2018.
Excluding non-cash gains or losses for stock-based compensation, non-GAAP
adjusted net income was $4.5 million and non-GAAP adjusted net loss was $7.0
million for the three and nine months ended September 30, 2019, respectively,
or non-GAAP adjusted basic and diluted earnings per share of $0.01 and loss
per share of $0.02, respectively, compared to non-GAAP adjusted net loss of
$17.8 million and $68.7 million for the corresponding periods of 2018,
respectively, or non-GAAP adjusted basic and diluted loss per share of $0.06
and $0.24, respectively.
Cash and cash equivalents were $673.2 million as of September 30, 2019. Net
accounts receivable were $103.6 million ($133.5 million in gross accounts
receivable before allowances and reserves) as of September 30, 2019.
Net cash flows, excluding net proceeds from the equity offering completed in
the third quarter of 2019, was positive $11.3 million and negative $16.1
million for the three and nine month periods ended September 30, 2019,
respectively.
As of September 30, 2019, Amarin had approximately 357.2 million American
Depository Shares (ADSs) and ordinary shares outstanding, 28.9 million common
share equivalents of Series A Convertible Preferred Shares outstanding and
approximately 16.3 million equivalent shares underlying stock options at a
weighted-average exercise price of $6.21, as well as 9.4 million equivalent
shares underlying restricted or deferred stock units.
Conference Call and Webcast Information
Amarin will host a conference call at 7:30 a.m. ET today, November 5,
2019. The call will be webcast live with slides and accessible through the
investor relations section of the company’s website at www.amarincorp.com.
The call can also be heard via telephone by dialing 877-407-8033. A replay of
the call will be made available for a period of two weeks following the
conference call. To hear a replay of the call, dial 877-481-4010 (inside the
United States) or 919-882-2331 (outside the United States). A replay of the
call will also be available through the company's website shortly after the
call. For both dial-in numbers please use conference ID 55910.
Use of Non-GAAP Adjusted Financial Information
Included in this press release are non-GAAP adjusted financial information as
defined by U.S. Securities and Exchange Commission Regulation G. The GAAP
financial measure most directly comparable to each non-GAAP adjusted financial
measure used or discussed, and a reconciliation of the differences between
each non-GAAP adjusted financial measure and the comparable GAAP financial
measure, is included in this press release after the condensed consolidated
financial statements.
Non-GAAP adjusted net loss was derived by taking GAAP net loss and adjusting
it for non-cash stock-based compensation expense. Management uses these
non-GAAP adjusted financial measures for internal reporting and forecasting
purposes, when publicly providing its business outlook, to evaluate the
company’s performance and to evaluate and compensate the company’s
executives. The company has provided these non-GAAP financial measures in
addition to GAAP financial results because it believes that these non-GAAP
adjusted financial measures provide investors with a better understanding of
the company’s historical results from its core business operations.
While management believes that these non-GAAP adjusted financial measures
provide useful supplemental information to investors regarding the underlying
performance of the company’s business operations, investors are reminded to
consider these non-GAAP measures in addition to, and not as a substitute for,
financial performance measures prepared in accordance with GAAP. Non-GAAP
measures have limitations in that they do not reflect all of the amounts
associated with the company’s results of operations as determined in
accordance with GAAP. In addition, it should be noted that these non-GAAP
financial measures may be different from non-GAAP measures used by other
companies, and management may utilize other measures to illustrate performance
in the future.
About Amarin
Amarin Corporation plc. is a rapidly growing, innovative pharmaceutical
company focused on developing therapeutics to improve cardiovascular health.
Amarin’s product development program leverages its extensive experience in
polyunsaturated fatty acids and lipid science. Vascepa (icosapent ethyl) is
Amarin's first FDA-approved drug and is available by prescription in the
United States, Lebanon and the United Arab Emirates. Amarin’s commercial
partners are pursuing additional regulatory approvals for Vascepa in Canada,
China and the Middle East. For more information about Amarin, visit
www.amarincorp.com.
REDUCE-IT® Study
REDUCE-IT, an 8,179-patient cardiovascular outcomes study, was completed in
2018.(1) REDUCE-IT was the first multinational cardiovascular outcomes study
that evaluated the effect of prescription pure EPA therapy as an add-on to
statins in patients with high cardiovascular risk who, despite stable statin
therapy, had elevated triglyceride levels (at least 135 mg/dL). A large
portion of the male and female patients enrolled in this outcomes study were
diagnosed with type 2 diabetes.
More information on the REDUCE-IT study results can be found at
www.amarincorp.com.
About Cardiovascular Disease
Worldwide, cardiovascular disease (CVD) remains the #1 killer of men and
women. In the United States CVD leads to one in every three deaths – one
death approximately every 38 seconds – with annual treatment cost in excess
of $500 billion.(1)(, 2)
Multiple primary and secondary prevention trials have shown a significant
reduction of 25% to 35% in the risk of cardiovascular
events with statin therapy, leaving significant persistent residual risk
despite the achievement of target LDL-C levels.(3)
Beyond the cardiovascular risk associated with LDL-C, genetic, epidemiologic,
clinical and real-world data suggest that patients with elevated triglycerides
(TG) (fats in the blood), and TG-rich lipoproteins, are at increased risk for
cardiovascular disease.(4)(,) (5)(, 6, 7)
About VASCEPA(®) (icosapent ethyl) Capsules
Vascepa (icosapent ethyl) capsules are a single-molecule prescription product
consisting of the omega-3 acid commonly known as EPA in ethyl-ester form.
Vascepa is not fish oil, but is derived from fish through a stringent and
complex FDA-regulated manufacturing process designed to effectively eliminate
impurities and isolate and protect the single molecule active ingredient from
degradation. Vascepa, known in scientific literature as AMR101, has been
designated a new chemical entity by the FDA. Amarin has been issued multiple
patents internationally based on the unique clinical profile of Vascepa,
including the drug’s ability to lower triglyceride levels in relevant
patient populations without raising LDL-cholesterol levels.
The FDA has not completed its review and made a final determination on a
supplemental new drug application related to REDUCE IT. FDA has not reviewed
the information herein or determined whether to approve Vascepa for use to
reduce the risk of major adverse cardiovascular events in the REDUCE-IT
patient population.
Indication and Usage Based on Current FDA-Approved Label (not including
REDUCE-IT results)
* Vascepa (icosapent ethyl) is indicated as an adjunct to diet to reduce
triglyceride (TG) levels in adult patients with severe (≥500 mg/dL)
hypertriglyceridemia.
* The effect of Vascepa on the risk for pancreatitis and cardiovascular
mortality and morbidity in patients with severe hypertriglyceridemia has not
been determined.
Important Safety Information for Vascepa Based on Current FDA-Approved Label
(not including REDUCE-IT results) (Includes Data from Two 12-Week Studies
(n=622) (MARINE and ANCHOR) of Patients with Triglycerides Values of 200 to
2000 mg/dL)
* Vascepa is contraindicated in patients with known hypersensitivity (e.g.,
anaphylactic reaction) to Vascepa or any of its components.
* In patients with hepatic impairment, monitor ALT and AST levels periodically
during therapy.
* Use with caution in patients with known hypersensitivity to fish and/or
shellfish.
Thanks all for the feedback
Appreciate it
Retire, I thought the same. But saw a tweet about it. That’s why I posted asking for clarification from the board here