Esperion Therapeutics, Inc. (ESPR) Earnings Call Transcript & Summary

Okay. We will continue with the next session. Good afternoon, everyone, and thanks for hanging up -- hanging in with us here at the Goldman Sachs Healthcare Conference. I'm Paul Choi, the SMID-cap Biotechnology analyst here at GS. And we'll continue with our next session, which is Esperion Therapeutics. We're joined from the management today by the CEO, Tim Mayleben. What we'll do here, as with past sessions, is I'll turn it over to Tim for some opening comments. And after that, we'll go into the Q&A. If along the way, as in past sessions, if any investors have comments or questions, please feel free to submit them via the Goldman Sachs research portal. Or alternatively, you can e-mail questions to me directly. And time permitting at the end, we'll try and squeeze in a question or 2, if we have room for them. Otherwise, with that, I'll turn it over to Tim for an overview and maybe some opening remarks. Tim?

Thank you, Paul. And I want to start out by just thanking Paul and his team and the team -- full team at Goldman Sachs for the opportunity to be with you on this webcast this afternoon, virtual webcast. So as Paul mentioned, I'm President and CEO of Esperion Therapeutics. We are, I'm proud to say, a commercial stage pharmaceutical company. And we have 2 approved products, both approved in February of this year in the U.S. and actually late March, early April in the EU. We have formally made both NEXLETOL, which is formerly known as bempedoic acid, available to physicians as of March 30, we started our formal promotional activities the week of April 20. And then just last week, we made NEXLIZET, which is the combination -- fixed-dose combination of bempedoic acid and ezetimibe or Zetia available Thursday of last week, and we expect to start promotional activities around that product next Monday, so the week of the 15th. These are LDL cholesterol-lowering medicines for patients who have elevated levels of LDL cholesterol. We estimate that there are approximately -- we and others, estimate that there's about 18 million patients in the U.S. who are on statins or are on what are called their maximally tolerated statin therapy who need additional LDL cholesterol lowering. And that, broadly speaking, is our target market here in the U.S. And we, like I said, are just initiating our promotional activities. Just to provide some initial context of what we've been living through, I think it's -- you'd have to have lived under a rock for the last few months to not know that we launched our medicines in the midst of a pandemic. In fact, I would argue, at the height of the COVID-19 pandemic. We didn't know -- no one knew what life was going to be like and for how long. I think what we've experienced over the last couple of months, if we look at -- I guess, almost 3 months now, if you look at mid-March as sort of the initial point of COVID-19 impact, I think what we've seen over the last 3 months is a very rapid and complete shutdown in certain parts of the country. And now we're starting to see some reopenings around the country over the last month or so. But certainly, the initial 2 months were characterized by broad and relatively complete shutdown of virtually all economic activity, including health care. If we look at the initial weeks of our launch, and again, we measure this, we have about 300 territory managers that are on our, what we call, our customer-facing team, if we look at the number of HCP engagements that they could muster over the first few weeks of the launch, it averaged about 1,000 per week. So that's about 3 per week because there were so many physician offices that were closed, there were so many patients who weren't coming into physician offices. And since around mid-May, we've seen a gradual reopening. And whereas before, we were -- that is through April and May, we were averaging about 1,000 HCP engagements per week. We are now seeing, as of last week, about 2,500 HCP engagements per week, and we expect, when this week is complete, that number will be in the 3,000 range. And that compares to about 10,000 HCP engagements per week if you think about what a normalized activity level would be. What we're hearing from physicians, health care providers, whether it's independent physician offices or integrated delivery networks or hospitals, is that they are starting to return to -- they can see a trajectory toward relatively normal patient caseload volumes. And when I say relatively normal, what we're hearing is that by July, again, just generally across the country, we could see something on the order of about 70% to 80% of normalized patient case load volume, and so we've been suggesting to the investment community that we would expect that our territory managers then could return to about 70% to 80% of normalized HCP engagement volumes. So if we're at 2,500 last week, we'll be in the 3,000s this week. You can see week-by-week that, that will increase to perhaps 7,000 to 8,000 by the time we get past the 4th of July holiday. So of course, we've had weekly script volume. Ours is a fully retail launch. So 90% to 95% of the prescription volume is being captured by Symphony and IMS. We're measuring those in RPEs or retail prescription equivalents. And those have been -- sadly, those have been being measured in 2 and 3 digits, so far. But we certainly see a time in the not-too-distant future where we will start measuring weekly prescription volume in 4 digits, and we've been guiding -- again, broadly, we've been guiding the investment community to look at Q2 as launching in the pandemic, that is look at it for what it is and not a measure of the demand for our medicines over the long term because of physician offices being closed, stay-at-home orders in almost every state in the country, patients not coming into physician offices. But as those activities return to normal, which we expect, like I said, in July, some return to normalcy or 70% to 80% of normalcy, then that's where we would want the investment community to start keeping score, if you will, and tracking our prescription volume as some measure of the ultimate demand of our medicines. And again, to keep in mind, long term, what we've said is that at peak, we could see $1.8 million, perhaps as many as 2 million patients on our therapies at peak. And so we're definitely in the very low foothills of that ultimate peak volume, but that's where we are today.

Great. Thanks for that, Tim. Maybe just a follow-up on that thread of thought with regard to the impact from COVID here. Have you thought about the impact as you think about your timing of any milestones, either on the U.S. or European side, potentially being affected here by COVID? And just is there anything that you'd want to communicate to the investment community here as just given you're facing a headwind as the rest of the industry? And just how to think about time lines, apart from the script cadence?

Yes. No, thank you, Paul. It's a great question. And I'm happy to say that we're in weekly contact with our longest tenured partner, which is Daiichi Sankyo Europe, about their plans for the launch in Europe. And they are on track to launch -- the brand names in Europe are NUSTENDI and NILEMDO -- or NILEMDO and NUSTENDI for NEXLETOL and NEXLIZET. And so they are planning to launch a -- do a virtual launch meeting next quarter and then launch the medicines in Europe. As you've probably seen or you may have seen, Europe is -- has gone through the peak, obviously, of the COVID-19 impact. They have reopened. I think their -- the number of cases that they're seeing COVID-19 cases is down 70% from peak. So they're -- and it's continuing to go lower each and every month in a nice trend. So they've been past the peak. And I think DSE is telling us that they feel comfortable launching, we have a $150 million milestone tied to their initial commercial launch. And so we're very confident that we will see that milestone next quarter, if not before. And of course, Otsuka in Japan is our partner -- relatively recent partner. We already have collected the $60 million upfront. It will be some time before they start paying us additional milestones and royalties. But in the meantime, as you may have remembered from our announcement, they're spending, I think, something on the order of $100 million between now and approval. A little north of $100 million that, fortunately, we won't have to spend. So we're certainly going to enjoy the benefits of them spending on the clinical trials, the regulatory approvals in Japan, and then ultimately paying us the additional milestones and begin to pay royalties perhaps as early as 2024.

Great. You talked a little bit earlier about what the early script volumes have looked like. And I would agree for your product launch as well, other new products that are launching here in this environment. Right now, we're probably not getting the true picture of what the drug could look like over the longer term. But could you maybe speak a little bit as to what does your commercial setup look like? What are you and Mark have done in terms of your sales force sizing at this point? Is it fully built out at this point? And obviously, the NEXLIZET approval came downstream of the original NEXLETOL approval. So can you maybe just talk about what is your commercial setup here? And how has that been progressing?

Yes. No, it's a good question. So if you recall -- you may recall, that we worked with ZS Associates to -- which is, I think, probably the largest and most well-respected firm that does this work on market sizing, sales force sizing. So we worked with them on sizing our sales force. And the initial sales force sizing work resulted in this almost 300 territory managers for the initial launch. And that's driven by a couple of things. One, obviously, when you launch initially, you don't have all of the managed care coverage formulary access that you're going to have a year or 2 into a new medicine launch, or in our case, new medicines launching. Secondly, of course, it takes some time to build a promotional footprint. So to get the marketing messaging out, to get the speakers trained, so for the peer-to-peer education, to gain awareness of the medicines through, again, all of the online, off-line and eventually DTC TV activities. So during this initial phase, we are rightsized, if you will, for -- with the 300 territory managers. And the corollary that we've been using is the Xarelto launch, which was -- Xarelto was a cardiovascular product, a once-daily drug. It was a first-in-class, in that case, Factor Xa inhibitor. And it launched -- it was launched by J&J with about 300 territory managers. So that's the corollary that we're using. Of course, over time, J&J scaled up that U.S. sales force to something on the order of 1,100, 1,200 territory managers as they achieved sales milestones, prescription volume milestones and as they added additional indications. And of course, we have similar plans that, over time, as we achieve -- so we went from the introduction of NEXLETOL, now the introduction of NEXLIZET, over time, we will add -- through life cycle management, we will add additional indications and likely an additional combination product. I think you've probably heard us talk about the combination of our drug, bempedoic acid, with atorvastatin, which is the most popular statin by prescription volume. It is, I think, on its way to accounting for 60% of every generic statin prescription. So the idea of putting together a combination tablet with atorvastatin will help bempedoic acid be used earlier in the treatment paradigm. And then, of course, the cardiovascular disease risk reduction indication, we're expecting in the 2023 time line -- time frame as well. So as we achieve milestones, revenue milestones, prescription volume milestones, as we add new products, life cycle management products, as we gain additional indications, again, if you follow the trajectory of the Xarelto sales force build, I think that is a very good corollary for us. And again, we'll be tracking ourselves. We've suggested to investors that they measure us against the revenue milestones, percentage of revenue milestones that a drug like Xarelto achieved. So I think that's the right way to think about it.

Okay. That's very helpful, Tim. Maybe just to follow up on that. You talked about next week launching NEXLIZET, which is your fixed dose combination product here. And I think in the past, you've talked about that fixed dose combination being the primary driver of the franchise in terms of potential revenue mix, and so can you maybe comment on how you think both that plus the opening up of cardiologist office that you talked about earlier might drive the trajectory, both in the near term -- near to intermediate term?

Yes. No, it's -- I think that is the most timely question, Paul. The -- honestly, again, I don't think we could have predicted this, but we are pinching ourselves now not only about the decision to delay or put a little bit of separation between the launch of NEXLETOL and NEXLIZET, but also the decision to bring forward the launch of NEXLIZET about a month from our original plans because we've done so much physician HCP education over the last 2.5, almost 3 months now with the COVID-19 pandemic, the closing of physician offices, the patients staying in home, even with the implementation of telemedicine, which we've all read and heard so much about by physician offices. Patient case load volumes at physician offices were way down, so they had more time. And the way they chose to use that time was on education on new therapies. And so we benefited mightily from that. So the peer-to-peer education, we started in late April with our first -- we were doing 2 a week of these sort of national peer-to-peer education seminars on NEXLETOL, and we were getting -- I think in one session, we had over 200 physicians for an evening session, and we were averaging something on the order of 50 HCPs attending these evening sessions, and they're hour-long sessions where there's a presentation followed by a question-and-answer session. So -- and the number one question, believe it or not, was exactly the one that we predicted, "tell me more about the mechanism of action." I don't know what ACL is. I don't know what ACL inhibition is. Where is it? And then when we explain, it's on the biosynthesis, cholesterol biosynthesis pathway, just upstream from statins, it was the bells went off in people's heads, "Ah, it's familiar." So that has gone extraordinarily well. So now we find ourselves in a position where there's literally thousands of physicians now that have learned about ACL inhibition. And we -- they're taking meetings with our territory managers. They're reopening their offices. The patients are coming back to the physician offices, and then we have the great benefit of being able to launch this medicine, NEXLIZET, which for those that have been using ezetimibe, is -- that is patient -- physicians who have been prescribing ezetimibe, is just a gift because they know their patients are already familiar with ezetimibe, they're using it primarily in patients who are not able to take a statin. And so to be able to get 35%, 40% LDL cholesterol lowering with a single tablet, a single pill with a very low out of patient copay, the copay card has been working phenomenally well so far. Those are all resonating messages that are really resonating well with physicians. So with the states reopening, with physician offices reopening, with patients returning to their physician offices and now focusing on their long-term health, it seems to be the most prescient time to be able to launch the new medicine. So we are expecting big things there, like I said, starting next month. We're definitely expecting to see measuring our prescription volumes in 4 digits weekly, prescription volumes in 4 digits, not 2 or 3 digits.

Okay. Fair enough. Maybe just to follow up on a point there that you talked about in terms of your interactions with physicians in these virtual sessions. Could you maybe comment on how you see, whether they're academic or community practitioners, where they see NEXLETOL and NEXLIZET fitting in. You talked a little bit about statin-intolerant patients who are on generic Zetia at the moment. Is that where they primarily see it? Or where are they talking about primarily in terms of the patient treatments and patient pool as being probably the most appropriate patients in their mind based on your early feedback?

Yes. So this is interesting. It is -- well, interesting in the sense that what we saw in our market research, and again, I would just qualify everything I'm going to say by saying, we're only 2 months into -- if we start April 20, we're only a couple of months into the launch. And we're measuring total prescription volume in 4 digits, not 5 or 6 digits yet. But with those caveats, what I would say is, overwhelmingly, what we're hearing is consistent with our market research, which is patients on maximally tolerated statin therapy. So that, in some cases, as you were saying, some cases, that means no statin at all. In other cases, it means patients who are taking a statin don't want to take a higher dose of a statin or they've been on a higher dose of a statin, can't tolerate it, but still need additional LDL cholesterol lowering because the physician brought them down to a lower dose of a statin. But the bottom line is all of these patients are needing additional LDL cholesterol lowering. And so we're seeing unanimity, if you will, in terms of how physicians are thinking about using it. Importantly, I would say, it is being viewed as, I'll call it, second-line therapy. So it's after maximally tolerated statin therapy. And again, for the most part, I'm not going to say this is universal, but for the most part, we're seeing physicians looking at the PCSK9s, because they're injectable, because they're expensive, because you can't start a patient virtually on a PCSK9, we've heard of people trying, but it's -- that's a very difficult thing to do to educate a patient virtually on an injectable therapy. This is really resonating well with physicians. And I would also say, this is also helped by the payer contracting that we've done. So the PBMs, as you know, are not leaving treatment decisions solely to physicians anymore. They're helping to influence them. They're helping to influence by formulary positioning, by determining what copays or out of pockets will be for patients. And we're definitely seeing that influence in the formulary positioning for our medicines that payers are putting them at Tier 2. That's preferred brand. And that is -- and as I mentioned earlier, the copay card is working extraordinarily well. So for commercially insured patients, that's $10 out of pocket, $10 copay for up to a 90-day prescription, and that is giving physicians a lot of confidence to prescribe the medicines, our medicines, because patients are going to pick them up, they're going to be able to afford them and they're not going to get any barriers at the pharmacy when they go to pick up their prescription.

Great. That's very helpful. Let's maybe continue a little bit on the payer side of things, since you mentioned that earlier, Tim. And in your last update, you talked about more than half of commercial coverage being accessed at this point and more than 20% of Part D. Can you provide us on what any -- what, if any, progress that you've made since your last update? And how we should think about access improving here over the course of 2020?

Yes. So this is an area we're particularly proud of, Paul, and I will just give a shout out to Jerry Penn and his team who heads up managed care coverage for us, because we are now up to 80% commercial coverage and over 50% Medicare Part D. So I want to emphasize 2 things. The important thing is not just covered lives, right? That's pretty easy to understand, or percentage of covered lives. That's -- the numerator, obviously, is how many patients in the plans or the PBMs have influence over or determination over. And then, of course, the denominator, this is simpler arithmetic denominator, is what is the total population of insured lives across the United States. And so that's pretty easy. Breadth of coverage is pretty easy to understand. When we say 80% or we say 50% Medicare Part D, that means of all the participants in Medicare Part D, we have over 50% of them here, what, 3 months after our launch. The more difficult thing to understand, I think, for those that aren't in the managed care space is really the quality of coverage. And -- but this is, I would say, really key to the economics of managed care. And so I'm going to try to explain this. But again, I'm not a managed care expert, but I'll do my best. So generally speaking, I think we're all familiar with tiering in managed care, that is Tier 1 is the highest tier. It is where generics live. And this is where access is easiest for patients, copays are lowest. They're $0, $5. This is the generic tier, like I said, where virtually no branded medicines live, right? The Tier 2 is what's called -- generally referred to as the preferred brand tier. And Tier 2 is generally considered the best or optimal tier for branded medicines like NEXLETOL and NEXLIZET. And the reason is pretty simple. The patient copays are generally very low, $10 to $20, for example. And patients, because they're considered preferred brand by the PBM or by the payer, then they provide generally easy access to these medicines for their planned participants. And so when we say we have high-quality coverage, what we mean with that 80% or 50% is that is the highest or best or optimal tiered coverage. It's almost exclusively tier 2 coverage, preferred brand that is -- it's not quite the imprimatur of one of these PBMs saying, we approve this. It's just simply indicating the economics are going to be most favorable for planned participants. Tier 3 is generally called the nonpreferred brand tier. And it's a covered option. The payers or the PBMs list the product at a slightly higher copay. They can be $30 to $60, for example, out of pocket for patients. And we're -- again, we're -- we do have some plans that elect to put us on Tier 3 initially. And we could decide to stay there if that's the best thing, because we do have the copay card. So even if their patient copay is $30 to $60, they're only going to pay $10 with the copay card. I think thereafter, you've got Tier 4, which is cost sharing, this is not super attractive, because essentially, the patient has to pay 30%. So it's not a fixed copay, a fixed dollar copay, it's 30% of the total WAC price. And we don't have any Tier 4. Tier 5 is even worse. That's the so-called NDC block. The medicine is not covered at all. The only way to get the medicine is paying the full price. And again, we don't have any of that. So when we say high-quality coverage, it is, like I said, almost exclusively Tier 2 and some Tier 3 because the economics for us and the patients are most favorable. But like I said, with the copay card, most patients are going to pay that $10 out of pocket. And that's really what we want because we don't want disincentives. If the physician prescribes the medicine for the patient, we want that patient to be able to afford it and gain access to it.

Great. Thanks for that, Tim. Maybe just to round out the payer coverage discussion. You've made great and very quick progress, so congratulations to you and your team on that. Just sort of what's left in terms of boxes to check on the commercial side in terms of any major plans you want to call out? And then on the Medicare side, for that other -- about 50%, is it mostly managed Medicare that's sort of left to include here?

Yes. No, I think that you hit on it well. So there's another 50% of the Medicare Part D patient population that we want to make sure gets access to our medicines. I think on the trajectory that we're on, though, Paul, I think we can confidently say at this stage, not only with the managed coverage that we contracted with but also with the discussions that we're -- that we have ongoing with the other major PBMs and payers that this trajectory should continue. So within a year, we will have virtually all covered lives that is within a year of launch, we should have all of the covered lives that we would want to have. And like I said, our managed care team is continuing to work very, very closely with payers because we said from the beginning, look, we're partnering with folks on this. We are not adversarial. We are working to make our medicines accessible to patients, affordable for patients, and that's what we've been able to achieve.

Okay. Yes. Great. Maybe one more here. Just you talked a lot about the $10 copay for patients to help improve access to it and the tiering. But as with all new products, investors often wonder what the gross net will look like for this product? And can you maybe talk a little bit about -- you don't have a lot of volume, so we don't have a lot of data at this point to sort of help understand what's going on here. But how should we look for gross net to look like over the near term? And how do you see it evolving as the product grows in scale and size?

Yes. So I'm going to tell you what -- or I'll maybe give you the input that Rick, our CFO, likes to provide, and then maybe talk a little bit more about it. But generally, what Rick has been saying about this is that we're not going to give specific GTN or gross-to-net guidance. There's all sorts of competitive reasons for that as well as relationship matters that we need to consider. But having said that, I think we can look across the spectrum of the pharmaceutical industry, the bio industry, biotechnology industry, and we can say, when we look at the landscape, we see a range of gross-to-nets that are talked about. So for orphan products, for specialty drugs, maybe leave it at that, you can see gross-to-nets in the 10% to 20% range, right? So very modest because they're one-of-a-kind product for a rare disease, and so they're expensive products, but gross-to-net is actually quite modest. Contrast that with, again, an area that we're somewhat familiar with because it's neighboring to the cardiovascular space, and that's in the diabetes space. In the diabetes space, I would point to the SGLT2s. The SGLT2s, of course, I think there are 5 different SGLT2s competing for compendia classification, formulary space. And you see gross-to-nets in the 75% range, so really deep discounting. You've seen steady increases in WAC prices and either flat or lower net prices that the various manufacturers have been reporting. And what I think we've been trying to say is we're neither one of those. We are an ACL inhibitor, our medicines are ACL inhibitors. They're in their own compendia classification. We're not competing. They're not competing for any formulary space with any other ACL inhibitors. And so as a result, we expect our gross-to-net to be kind of in the middle there. So I think that's, I think, the best guidance that we can give at this stage. It's -- and again, the proof will be in the pudding. Obviously, as you said, as prescription volumes pick up, we'll be able to talk about real numbers, but I think that's a good way to think about the error bars, if you will.

Okay. Great. That's very helpful. I'm getting the tap on the shoulder that we only have a few minutes left here. So maybe in our remaining time, Tim, you could maybe talk a little bit about what is -- it's only been a few months, but what does sort of real-world adherence look like in terms of real-world stickiness or adherence rates? Or maybe alternatively, can you talk a little bit about what refills have been looking like so far?

Yes. Yes. So I think you're right. I think it is early to -- for us to speculate about adherence. We are seeing -- I think, a couple of things to think about is, one, what we're seeing in terms of patients actually filling their prescription is actually very high at this stage, north of 70%. And that is quite positive. I think, at a run rate, when we're up at a normal run rate, we would expect that number to be up to 80% because there's always -- with chronic medications like this, there's always some patients who won't fill the prescription, and so -- for various reasons, some economic. We've tried to take the economic factors out of the equation. Some are just never going to be compliant. And again, if you look, I think, across the industry, that's a pretty high rate, but that's what we expect, given the efficacy and tolerability profile of our medicines. So what we're seeing so far in that regard, gives us a lot of confidence that as we get enough data under our belts, that we'll be able to talk more clearly about adherence and about refill rates as well. So I think stay tuned. We'll be starting to talk about that on future quarterly conference calls, probably not on this upcoming -- our Q2 call, again, because of the pandemic issues. But I think, certainly, later this year, we'll be quite transparent with the investment community about just how all of that is going.

Great. Maybe in our last minute or 2 here, we could talk about your cardiovascular outcomes trial, which is enrolled. But could you maybe just talk about how follow-up is going on that? And then how you think maybe -- since the top line data is still a few years off, how you think about sort of the near-term commercial performance without a cardiovascular outcomes claim on the label versus what the sales growth might look like down the road with something on the label?

Yes. So it's a good question, in particular, about the commercial performance, if you look back at LDL cholesterol-lowering drugs historically, because of the strength of the LDL cholesterol-lowering hypothesis, that is there's been this long connection between lowering LDL cholesterol, especially through liver mediate -- liver cell mediation that there's a strong belief that if you lower LDL cholesterol by -- in our case, inhibiting cholesterol on the cholesterol biosynthesis pathway through this enzyme, ATP citrate lyase, that you're going to get a CV risk reduction benefit. So that's -- it's not quite gospel, but it's close to gospel. So what we see is, there is the occasional physician that will say, I don't want to use these medicines until you have -- see the outcomes data. But if that's 1 out of 100, it might even be less than that, Paul, that almost every physician today has been trained to believe that if you lower LDL cholesterol, especially, again, along the cholesterol biosynthesis pathway, that you're going to get a CV risk reduction benefit. So there's high confidence in that. And as a result of that, we don't see a whole lot of difference in physicians' willingness to prescribe our therapies, pre-CVOT results versus after we get the CV risk reduction results and the indication in the label. We are still on track to -- that is we are tracking each month the number of events, and we are tracking very well, in fact, slightly ahead of the predicted event rate even in the midst of COVID-19. We've got very good retention in this study, which -- that is patient retention, of course, with a long-running study like this, that is what's measured in 5 or 6 years, which is something you're always focused on. But we're seeing, even in the midst of the COVID-19 pandemic, that we've seen very good retention in the study, patients continuing to take their medicine. So I think the CVOT, we continue to feel extraordinarily good about. And keep in mind, it's 14,000 patients. All of the patients are statin intolerant, so they're not taking an approved daily starting dose of a statin, which puts their risk -- their CV risk higher just because they're not on a background of statin. The patients coming into the study, we now know, had baseline LDL cholesterol levels on average of over 140 mg per deciliter, which is twice what it was in IMPROVE-IT, and a full 50% greater than what they saw in either of the 2 more recent studies for Repatha and PRALUENT. And then, of course, because our drug lowers HSCRP as well, we are also looking at baseline HSCRP levels, and we're seeing those well north of 2 mg per liter, which, of course, 2 mg per liter is the bright line that has been drawn for inflamed or not. So we feel very good about the design decisions that we made choosing statin-tolerant patient population, getting this patient population with very high baseline LDL cholesterol levels and high HSCRP levels as well. So we're continuing to look to the second half of 2022, so just a couple of years -- or a couple of years now -- from now where we'll have accumulated all of the event rates and then soon thereafter to be able to report results.

Okay. Great. Thanks for that, Tim. Unfortunately, we've run over on time, so we'll have to stop and end it on that note. My thanks to Tim and Esperion for participating here in the Goldman Sachs Healthcare Conference. Thank you very much, Tim. Take care.

Thank you, Paul. Great seeing you again. Take care.

Okay. Bye.