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Goldman Sachs 45th Annual Global Healthcare Conference

Jun 12, 2024

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay, we'll continue with the next session. I'm Paul Choi, and I cover mid-cap biotechnology here at the firm. It's my pleasure to welcome Esperion Therapeutics to this session. Joining us on stage is CEO Sheldon Koenig. So maybe what we'll do, Sheldon, for people in the audience who may be unfamiliar with Esperion, can you maybe just provide a brief overview of the company, sort of your key, you know, key core competencies and sort of the key markets you target? Maybe just provide an overview of the company to start.

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah, great. Thanks, Paul, and I just wanna thank you and Goldman Sachs for having Esperion here at the conference. It's definitely great to be here. I just wanna put a plug in. We were actually just voted a great place to work, so we're really proud of that. We posted it on LinkedIn yesterday. More information there to see that. So, Esperion as a company, was founded in 2008, by Dr. Roger Newton, and to fast-forward, he developed a drug called, bempedoic acid, which is a novel, mechanism, first-in-class, product that lowers LDL cholesterol. And to fast-forward, these drugs were approved back in March of 2020, which was right in the middle of COVID, so it wasn't the best time to launch a drug.

We came up with a strategy, and we really wanna focus on the CLEAR Outcomes study, getting to our label, et cetera, and that's what we did. So in April of 2023, we presented the CLEAR Outcomes study, which was a 14,000-patient outcome study. And it was a very diverse study. 49% of the study participants were women, 18% Latin American, and 70% of folks studied were secondary prevention, 30% primary prevention. We'll get into that a bit later, and many of the patients also, you know, were sick, you know, diabetic or pre-diabetic. That study was presented, as I said, by Dr. Steve Nissen. It was an overall success.

We talked about then really focusing on getting our labels, which we did, back in April of this year, and we've been off to the races with this product, calling on both primary care physicians, and cardiologists. And I know later, I think we're gonna maybe talk about our pipeline, which is also very interesting. More to come on that.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay, great. Yeah, for those of us who've been following this space for a while, maybe in its own way, this company is now Esperion 2.0 or 3.0, depending on how you count it, in current terms of its long history of developing cholesterol drugs, including a small one called Lipitor, if I recall correctly.

Sheldon Koenig
CEO, Esperion Therapeutics

That is correct. Roger Newton was a co-developer with Lipitor, and I think our vision says it best. You know, we're in the business of providing life-saving drugs, not only for now, but in the future, and not only for cholesterol, but in the future, other areas.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay, great. So, maybe, Sheldon, touching on what you just mentioned there, your recent label expansion, it's clearly significantly addressed the increased addressable patient population. And so can you maybe just remind us, you know, what is the scope of your new label? How does it differ from your prior label, at least here in the U.S. and in Europe as well?

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah. So our old label is very restrictive. The TAM that we were able to address was only 10 million patients, and that was for a couple of reasons. One, a patient had to show documented ASCVD, which is atherosclerotic cardiovascular disease. A patient had to be treated on the maximum tolerated dose of a statin. So it was very restrictive, and we didn't have outcomes yet, so payers were really holding us back from really being prescribed, and it was as simple as that. The new label now includes not only secondary prevention, but also primary prevention, and the beauty of that also is we no longer need to show that you have to have a maximum tolerated dose of a statin. We're able to show that we reduce events. We're able to reduce non-fatal MI by 27%.

We're able to reduce cardiovascular procedures, such as stent, et cetera, by almost 20%, and we're the only non-statin that can claim that we are indicated for both primary and secondary prevention, and that's a significant differentiator from not only, drugs like ezetimibe, but also PCSK9. So that label now has opened up the TAM. Remember I said earlier, it was 10 million, 70 million patients. And again, just to be reminded, as you know, Paul, cardiovascular disease is the number one killer-

Paul Choi
Biotechnology Analyst, Goldman Sachs

Mm-hmm

Sheldon Koenig
CEO, Esperion Therapeutics

... in the United States and the world, so this product can make a significant contribution in reducing deaths, et cetera, you know, with if, you know, if people are taking their drugs and lowering their LDL.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Right. Yeah, so yeah, the risk reduction label obviously has opened up a much, much larger market for you guys.

Sheldon Koenig
CEO, Esperion Therapeutics

Yes.

Paul Choi
Biotechnology Analyst, Goldman Sachs

I wanna actually touch on something you mentioned here, which is just, you know, sort of payer pushback in terms of the scope of the old label versus the current label. And I want to ask, you know, can you maybe comment a little bit on what you've seen in terms of payer behavior with regard to policy changes to accommodate this expanded label and just have the barriers in terms of the physician experience in prescribing and sort of back-office challenges to get reimbursement or approval or sign-off from the payers changed?

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah, I'll talk about this in both ways, one, the payer perspective, and also from a physician perspective, past and then into the future. So again, prior to the label, the biggest pushback was, again: "You do not have outcomes." It was simple as that. And because you do not have outcomes, you have to get a patient through maybe two statins, and then after two statins, maybe ezetimibe. You have to supply a lot of documentation, et cetera, to get these patients approved, and physicians don't have the time to do that, nor primary care or a cardiologist. They just don't have the time. We knew, and we knew right after ACC, that payers were willing to listen and hear about our new label, so we went right after ACC.

In December, the FDA actually made a change for our label, where you never needed the maximum tolerated dose of statin anymore, which was great, and that's because we did have outcomes, even though we didn't have the label. That allowed us to go back to payers again and preview to them what was coming in late March or late April. I'm just gonna say I'm really proud of our market access team. We have had over 10 wins since June 1, where not only is it easier to get Nexlizet, and that's really a new campaign for us. It's easier to get Nexlizet. There are some plans where there's not even a prior authorization. You just need the electronic look back to see if this patient was even on the statin.

So payers now, with the outcomes data, have been very open arms. And I think another contributing factor to that was we had an ICER opinion a few months ago that showed that from a pricing perspective, we are economically priced along with the outcomes that we provided. So I'm really proud of the team and, you know, we have two key messages after a statin, we're next, and now it's easy to get us.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay, great. And then, just, you were talking a little bit about the payer wins, but then the physician experience, you said now they can just submit a look back record in some cases-

Sheldon Koenig
CEO, Esperion Therapeutics

In some cases.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Yeah, depending on the plan, and, I guess the question is for, you know, the back office or the physicians' admin system, just, you know, what does that translate to in terms of requiring sales force touches and so forth?

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah. So we have 150 salespeople strong. We actually just added five key account managers. We also have six reimbursement specialists, so for some offices where they are finding they have some difficulty, we can target those people to that office, and that's going well. Again, these new payer wins have really opened the doors for us, and we're already seeing the momentum since June the first, and that's gonna carry significant momentum into the third quarter as well. Happy about that. We also have another bridge. We have what we call Aspen, which is a specialty pharmacy. That allows physicians, if they're having trouble with the PA, to work through Aspen, and what Aspen is able to do is do the prior authorization for them.

If, for some reason, they're running into some issues, they're actually able to supply the patient with a free bottle or a month's worth of product until that prescription gets prior authorized. I can tell you, we just had... Yeah, we filed this weekly. We had another tremendous week with Aspen. Those prescriptions, by the way, aren't necessarily covered in IQVIA-

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay.

Sheldon Koenig
CEO, Esperion Therapeutics

until you move over to paid. So it's been, like I said, a lot easier for physicians to get the drug with what we have established with payers now and the bridge that we've supplied in case they are having troubles.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay, great. Maybe one last question on the sales force piece and Aspen is, you recently got your label changed, and so I think maybe, you know, physicians who have been aware of the drug for a few years since your approval and launch in 2020 may not be fully aware of sort of the scope and changes to the label. And so just kind of where are you in terms of your sales force touches in educating the prescriber base? Does it, you know, require maybe a few more, you know, medical conferences, whether it's AHA, whatever the case may be, coming up here in the fall to just sort of increase awareness in the physician community of, you know, what the new product label looks like?

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah, I think the meetings that we have coming in the future, ESC, that will be the end of August. You know, again, I think it's important to note, it's not just Esperion that's in on this, right? There's a very large company, Daiichi Sankyo, that has about 25,000 employees, Otsuka in Japan, that has about 7,000 employees, and we meet regularly. I was just on the phone with our, business director in, in Germany. So there's a lot of collaboration of how do we get the message out wholly. At ESC, for instance, there's not only U.S. physicians, but European physicians, et cetera. AHA, the same. So that is one aspect. The other aspect is a consumer initiative that we have, which drives consumers into the office. It's played very well. It's called the Lipid Lurkers.

I just had them lurking on my Instagram and Facebook. If you're a target audience, you will see that as well. Then we have our representatives, as I, as I've mentioned, and we, we have programs where we have webcasts with key opinion leaders that are transmitted throughout the country, et cetera. It takes maybe sometimes five or six visits for representatives to get out there. But what's really been interesting, remember, I talked about we have an indication in primary prevention. We're seeing a lot more use in primary care physicians, which speaks to us that they're also using it for primary prevention. So we're really making some inroads there already. We can see that, and I feel really good about that.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay, great. This is somewhat backward-looking, but for last year, part of the challenge of thinking about the Esperion investment case was the ongoing litigation at the time with your partner, DSE. Now, that's behind you through an amicable resolution. Can you maybe just remind us on what are the amended terms of your agreement with them?

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah. So, look, last year was a stressful year. You know, we went through about 10.5 months of litigation. We were able to resolve that and announce that in January of this year. So in a sense, what we received is $125 million in cash from Daiichi Sankyo. We received $100 million at the end of January. We are receiving another $25 million in the next few weeks, based upon their approval in Europe. The other thing that we did is we gave them the rights to develop triple combination, which keep in mind, once that's developed and marketed, we also get royalties from that triple combination. That's pretty significant, ranging between 15% and 20%. The other thing that we're doing is a tech transfer, and that's going along very smoothly.

That's where they will actually produce, produce both Nexlizet and Nexletol, Nilemdo and Nustendi, as it is referred to.

Paul Choi
Biotechnology Analyst, Goldman Sachs

In Europe.

Sheldon Koenig
CEO, Esperion Therapeutics

in Europe. So when you do a net present value analysis, remember the lawsuit was around a $300 million milestone. We actually can demonstrate that the result is above a $300 million value. And again, it allows the teams now to work collaboratively. It's in the past... And, I'm not a big hockey fan, but I know we're in Miami, and the Florida Panthers are playing, and they're 2-0 here. We've been back skating a lot, okay? But we're not back skating anymore. Like, we are on the offense now. Those distractions are gone. We have the outcomes, we have the label, that's resolved, and we have the capital to keep moving forward.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay, great. Maybe a question on the triple combo development. Will you run that, or will DSE run that? And then just sort of in terms of broad clinical development requirements, can you just do a bridging study, or does a full-on, you know, given the ingredients are kind of relatively well known-

Sheldon Koenig
CEO, Esperion Therapeutics

Mm-hmm.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Can you just do a sort of bridging study, or just sort of what, what's required there to?

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah

Paul Choi
Biotechnology Analyst, Goldman Sachs

-a triple?

Sheldon Koenig
CEO, Esperion Therapeutics

So Daiichi Sankyo is. I mean, they are hot on this. They love this. This is something they've always wanted. I think they're going to do it with two statins, both rosuvastatin and atorvastatin, that remains to be seen. But it's a simple bioequivalent study. And then there's stability for six months, so it's a pretty quick program, where if you were to do a program like that in the United States, it would have to be a complete clinical study. They're paying for everything. They're doing everything.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay.

Sheldon Koenig
CEO, Esperion Therapeutics

Nothing out of our pockets to do that.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay, great. You touched on this briefly, but with the approval in Europe triggering this pending $25 million milestone from your partner, DSE, maybe can you speak broadly about, you know, or your capital needs and just sort of the strategy and sort of funding either commercial operations and/or or clinical development, and sort of what's the philosophy and on addressing potential future capital needs at this point?

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah. So we're in a great position with cash right now. We finished the quarter with about $226 million. As I mentioned, we're receiving another $25 million in a few weeks, before July 1st. We're in a great position from a capital perspective. What we're focusing on right now is really addressing our debt, and we hope to have a solution for that before the end of the year. This is something I think we can do without any further dilution, et cetera. We're really close to being break-even and cash positive. So, you know, you never say never, but right now we're in a really good place from a capital perspective and don't see, as it stands right now, any immediate need, et cetera, to go to the capital market.

So we're able to fund our business in the way that we need to. Again, keep in mind, a lot of our expenses last year, the year before, going back to 2019, if you will-

Paul Choi
Biotechnology Analyst, Goldman Sachs

Mm-hmm

Sheldon Koenig
CEO, Esperion Therapeutics

... was all to fund the $600 million CLEAR Outcomes study. That's done. So that allows us to, you know, be smart about our spending and only spend where we see really good return on investment.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay, great. So you obviously identified a major operational expense in terms of at least backwards looking, running an outcomes trial. Obviously, it's not a trivial endeavor. It's a substantial investment. Your R&D, you know, as a percentage of your sales on the forward, theoretically, should go down meaningfully-

Sheldon Koenig
CEO, Esperion Therapeutics

Mm-hmm. Mm-hmm

Paul Choi
Biotechnology Analyst, Goldman Sachs

... and start to generate significant leverage-

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah

Paul Choi
Biotechnology Analyst, Goldman Sachs

... as you commercialize in the new expanded indication. So I guess, you know, as you think about maybe just in broad strokes, the sort of cost structure, you don't have huge outcomes trials to run near term, but you are developing other, earlier to mid-stage assets. So what is the sort of shape, I guess, broadly of the P&L look like in your mind as you and the management team and the board sort of think about the intermediate to longer term outlook?

Sheldon Koenig
CEO, Esperion Therapeutics

Well, I think the good news is we are where we need to be. So there's no need to further expand the business. We're fully staffed at 150 representatives. I mentioned the five key account managers.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Yep.

Sheldon Koenig
CEO, Esperion Therapeutics

So our commercial budget is going to be where it is. So we don't see any type of significant ramping versus where we are today. We're at the right size, where we need to be to make these products successful. We're showing it. We're already showing it. And part of it is just from a perspective of really being smart about X amount personal promotion, X amount digital promotion, et cetera. So, and again, from a payer perspective, you know, these wins that we've gotten, we were able to get without giving really any concessions because the contracts from the past had been aggressive. So from a gross to net perspective, we feel good about that as well. We don't see any, you know, variability going beyond where we already are. So again, we're in good shape.

I don't see any need to do... And you know, if we do talk about pipeline later, we even have money set aside to get us to where we need to get until we're at profitability. So from a spending perspective, we're in, we're in great shape.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay, great.

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah.

Paul Choi
Biotechnology Analyst, Goldman Sachs

I actually want to talk maybe a little bit about the pipeline now, if we can.

Sheldon Koenig
CEO, Esperion Therapeutics

Sure.

Paul Choi
Biotechnology Analyst, Goldman Sachs

And, you know, I think the focus has been sharpened recently by the growing sort of a return in investor interest in the cardiorenal space, broadly speaking. And, you have some early-stage programs that you've talked about but don't necessarily get a lot of airtime. So can you maybe remind us sort of what's next in the pipeline after bempedoic acid here?

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah. So we have a 2nd-gen ATP citrate lyase. It's very different than what we have focused bempedoic acid on. This is something that moves beyond LDL. We are actually going to have an R&D day sometime in the fourth quarter. We haven't announced when it's going to be, but there'll be a lot more detail there. And what I mean by that is, this is where we could be going, this is how it could displace competition that exists now and even competition in the future. It's very focused on kidney, heart, and liver. And we've actually seen some signals from an oncology perspective as well. But we're really looking at a specialty focus with kidney and liver. So more to come there.

We're really excited about, and I think I've said this before, Paul, is that it's hard to find small mid-sized companies that are not only commercializing assets, but also have assets in the pipeline. You know, we tried to talk about it back in, I think it was 2021, and that was probably a mistake because everyone was just wondering, "Well, what's going on with the-" It became the CLEAR Outcomes study, CLEAR Outcomes study. So now, with that behind us, we can really focus on R&D Day that will show assets that we think will have significant contributions to treating that cardiometabolic area.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay.

Sheldon Koenig
CEO, Esperion Therapeutics

So stay tuned. We're excited about it.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Great. One maybe another pipeline-related question is on oral PCSK9s. That's something you've mentioned in the past, but haven't given, like, huge clinical updates recently and just kind of... I think with the Merck MK-0616 program, it's still on people's radar-

Sheldon Koenig
CEO, Esperion Therapeutics

Mm-hmm.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Just sort of, you know, thoughts on that versus your 2nd-gen ATP lyase program. Just how do you rank order that? Sort of, you know, what is the commitment to, in terms of capital and thinking about advancing that program?

Sheldon Koenig
CEO, Esperion Therapeutics

Sure. Right now, I think the capital for our program and our pipeline is really to get to a point of doing, you know, IND, and we'll probably talk about more of that at our R&D Day.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Sheldon Koenig
CEO, Esperion Therapeutics

The Merck MK-0616 program. First of all, I just wanna remind everyone, we had an agreement with Seremetrix. We were developing an oral PCSK9. We gave the rights back to Seremetrix. I think the question for us was, do you really need an oral PCSK9 with bempedoic acid, et cetera? The MK-0616 program, you know, we'll be following that program. I think there's a lot of things to be said about that program from a, you know, a fasting perspective-

Paul Choi
Biotechnology Analyst, Goldman Sachs

Yeah

Sheldon Koenig
CEO, Esperion Therapeutics

... dosing, et cetera, so we'll see what happens there. But again, you know, the adjunct market, it's not PCSK9, it's ezetimibe. That's where the real opportunity is. More than 60% of the use in the adjunct market is ezetimibe, and that's really what we're focusing on. Our physicians, to just get away from the pipeline for a second, physicians who are currently writing statins and ezetimibe, you know, you could actually switch to a drug like Nexlizet. But the pipeline will be separate than... Not- it's not gonna be about LDL lowering.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay, great. I want to talk a little bit about life cycle management and, and IP, which is, you know, most recently, the, the USPTO, issued you guys a, a patent term extension through, if I've got this right, through December 2030. Can you maybe just remind us what's exactly included in your patent term extension and maybe, in broader strokes, you know, how are we thinking about the IP strategy longer term beyond 2030?

Sheldon Koenig
CEO, Esperion Therapeutics

Sure, yeah. We just announced that a few weeks ago. It's material of matter that gets us to that 2030 timeframe, and then from a pediatric perspective, we actually have patent protection to 2031. We actually think we can increase our patent protection all the way to 2040, and what will allow us to do that is we're developing a strategy, or I should say we do have a strategy. We recently, you may have seen, have gone through some ANDA litigation, and we believe that during that litigation, this can be an opportunity for us to actually expand our patent life into the 2040 time period. So that's something we've been preparing for, we were expecting and, you know, looking forward to executing on that and extending even beyond 2031.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay. And then, with regard to Europe, maybe just remind us where the IP's. You're talking about U.S. litigation-

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah, mm-hmm.

Paul Choi
Biotechnology Analyst, Goldman Sachs

-and so maybe just with your partner, DSE, what is the IP framework in Europe and other-

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah

Paul Choi
Biotechnology Analyst, Goldman Sachs

- ex-U.S. markets?

Sheldon Koenig
CEO, Esperion Therapeutics

So for Europe, it's actually very straightforward, and also the markets beyond that, the ASCA, Asia regions, et cetera. So for Europe, they actually have patent protection through 2031, and the development of the triple combination is going to give them an additional 10-year patent protection, so that will get them to 2041. As we've already covered, it's a pretty easy, quick development.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay, great. You know, you touched a little bit on prescriber behavior in the adjunct market, and as you sort of think about the competitive landscape and development for the adjunct market, at least, I know you're focusing on, in terms of your pipeline, on sort of beyond lipid-lowering and so forth. But maybe as you think about the competitive landscape, at least in on the cardiology side, what are you monitoring the most as potential challenges to Nexlizet here in the U.S. over the near- to intermediate term?

Sheldon Koenig
CEO, Esperion Therapeutics

Sure. I think definitely, you know, we're watching the development of the oral PCSK9. Obviously, we're watching the development of the CETP inhibitor. I'll start with that one first. I mean, it's definitely an interesting program. I think the thing about-

Paul Choi
Biotechnology Analyst, Goldman Sachs

You're referencing the NewAmsterdam-

Sheldon Koenig
CEO, Esperion Therapeutics

New Amsterdam.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay.

Sheldon Koenig
CEO, Esperion Therapeutics

I think what's... You know, with CETP, you know, we've seen five come to... I worked on one, anacetrapib. You know, none of them, you know, have made it. Most of them, if not all of them, show great efficacy. I think the question is really around safety. You know, what happens, you know, you know, with adipose tissue, et cetera? The MOA of CETP has never really been fully understood and explained. So it's not only efficacy, but safety, and then the other question is: How does efficacy translate into outcomes? So a lot more hurdles to go. The MK-0616 program, the AstraZeneca program, again, these are early, early programs. I think Merck is advanced past them. You know, they're also going to have to do an outcome study.

Last time I heard, in their outcome studies, by the end of 2030, they would have outcomes. So I'll bring it back to us selfishly. You know, we have outcomes today, and physicians and payers don't care about the products of the future. They care about, payers care about the products available today and the price they can get it at. Physicians care about the products that they can get today to treat patients, and that's what we're focused on. And if you're successful, just like ezetimibe was, if you build enough market share and leverage, it's harder for new products also to come in. So there's a lot of challenges, but of course, we'll follow their development program. And look, there's a need out there. There's 70 million patients out there who-...

You know, need more LDL cholesterol lowering, and we're doing it, you know, right now.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay. Maybe in terms of current competitors, you know, what does your sales force hear from physicians in terms of sort of the injectable landscape, whether it's siRNAs like Leqvio ? Is that even registering on physicians' radar at all? You know, whether it's given lack of outcomes data, challenges from a buy and bill model, making it difficult for them to hold drug on the shelf and not necessarily get paid for that, you know, versus a pill that's readily available. And just how does that, you know, what does your sales force hear out there? You know, what does your sales force hear out there?

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah, yeah.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Yeah.

Sheldon Koenig
CEO, Esperion Therapeutics

And we have meetings routinely to hear what's coming back. We're not hearing any pushback to our drug versus injectable PCSK9s, whether it be Repatha or inclisiran. Most physicians we talk to, they don't really know what inclisiran is, and they're not using it. At the end of the day, what we are hearing, especially with primary care physicians, because it's always hard for them to get injectables, is even if they, if they have the ability to get one, they give a patient a choice of, "You can take this pill, or you can take this injectable." They're picking the pill 9 out of 10 times. Especially now with our coverage, it's easier to get. You know, the one thing I failed to mention-

Paul Choi
Biotechnology Analyst, Goldman Sachs

Mm-hmm.

Sheldon Koenig
CEO, Esperion Therapeutics

This, you know, we talked about secondary prevention. In primary prevention, we showed in MACE- 3, which was fatal, non-fatal MI and cardiovascular death, almost a 40%, four zero, reduction in primary prevention. That has really resonated with primary care physicians, and they know... Cardiologists, too, but definitely primary care physicians, and they know that injectables do not have that data. So for them, it's like, "Wow, ezetimibe didn't have that data. Injectable PCSK9s, this is amazing." That's what we've heard.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay. I want to drill on that a little bit more in just terms of where your prescription volume growth and changes are going. We can't get a full picture, as you mentioned, 'cause some of the volume is coming through your Aspen. But just, I guess, where, as you can best tell, is the growth coming from? Is it primary, or is it just new secondary patients who are not having this insurance barrier anymore that you had in the past?

Sheldon Koenig
CEO, Esperion Therapeutics

Mm-hmm.

Paul Choi
Biotechnology Analyst, Goldman Sachs

I'm just sort of curious if you have that level of granularity to, to this point?

Sheldon Koenig
CEO, Esperion Therapeutics

We're getting close to that. Our initial belief is it's coming from primary prevention.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay.

Sheldon Koenig
CEO, Esperion Therapeutics

We're seeing more and more acceptance to primary prevention, and we're using the gauge of kind of the discussion you and I just had, feedback from the field, and seeing that more primary care physicians are using this drug. You know, if you go back historically, you look at ezetimibe, and you look at prescribing, it was 40% cardio... And that's a brand I ran for a while. 40% cardiologists were writing it, 60% primary care physicians were writing it. Again, it's easier for primary care physicians to prescribe a Nexlizet or a Nexletol versus an oral PCSK9. Now, you give them the power of they can do it for not only secondary [crosstalk]

Paul Choi
Biotechnology Analyst, Goldman Sachs

Injectable.

Sheldon Koenig
CEO, Esperion Therapeutics

I mean, injectable.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Yeah, yeah.

Sheldon Koenig
CEO, Esperion Therapeutics

Sorry. Now, you give them the power to do it for either, you know, secondary or primary prevention. And the one thing... I'll go back to years ago, we did some behavioral research, and what we found with physicians, especially primary care physicians, is they felt that: There's nothing we can do more. All we have is a statin and ezetimibe, and I really can't get an injectable. There's nothing I can do more. We're playing off of that behavior of, "Doctor, now there is more that you can do," and that's also resonating.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay, great. With the volume trajectory, you know, going up into the right with, with your label expansion here, I want to maybe just touch briefly on the subject of, of gross to nets in the, in the category and just kind of where you see maybe that evolving over time. Probably, I think, you know, in the earlier days of the launch, that was a bit of a headwind, just given, given some of the payer barriers that, that were in place. These are now largely gone, and is this something that you think the street is appreciating, that this is probably something that's gonna improve, or is this just sort of now that you're established as a product with the payers, it's just sort of, sort of par for the course? Maybe what are, what are your thoughts on that?

Sheldon Koenig
CEO, Esperion Therapeutics

I think it's two answers. It's par for the course, but it's already improved. You know, some of our largest GTN headwinds were DSA funds going through some of these large distributors, like McKesson, Cardinal, et cetera. We've showed significant volume progress, and those DSA fees have lowered. So it's kind of a paradox, like if you show more volume, then the DSA fees come down, and we were able to show that in January. So that really gave us some favorability from a gross to net perspective, and we feel good about that. We've come a long way in managing what were the original gross to net programs, to really bringing...

gross to net issue to bringing gross to net stable and, I would say, comparable, because we don't say what our gross to net is, comparable to other pharmaceutical companies and what they're probably paying, just, you know, from a gross to net perspective. So, I don't see any significant changes where gross to net is going to increase. If anything, maybe it could come down a little bit, but I feel really good about where we're at now, and it's become really worked out with us.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay.

Sheldon Koenig
CEO, Esperion Therapeutics

So.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Great. You know, as we think about the longer-term trajectory of the company and, you know, growing your Nexletol, Nexlizet franchise here, you know, you've often spoken about blockbuster potential, but the commercial trajectory, this year at least, is still relatively smaller. And just sort of, I guess, what is needed, I guess, to see that major inflection to get to that next sort of next-level tier of sales performance and making it a large cardiovascular franchise?

Sheldon Koenig
CEO, Esperion Therapeutics

I think part of it goes back to the questions you asked earlier, and that is getting the message out there. We've been very good at doing that. You know, we do not give guidance. We've said we're comfortable. We're consensus is this year between $150 million and $170 million. That's pretty significant growth from where we ended last year-

Paul Choi
Biotechnology Analyst, Goldman Sachs

Yeah

Sheldon Koenig
CEO, Esperion Therapeutics

... at $61 million. So, I think as time marches on, and it takes a while, you know, the cholesterol market is, is a large market. It takes months to kind of see that growth. We've always said we would show continuous growth. We always said it wasn't a hockey stick, it would be steady and growing. So this year, you know, we'll finish, you know, hopefully in that range, I believe we will, and then next year, I think even more significant growth. So, so we're on the right path to make these and committed to blockbuster, blockbuster potential.

I think people really are interested and love the science that's behind this drug, and we saw that at ACC, even when other companies came up to us and said, "Oh, wow, your labels are amazing." When we were recently at BIO, companies asking us about the science, et cetera. So physicians feel the same way about this drug and what it can do, and just the science behind it.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay. We're coming up on time here, so last question-

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah

Paul Choi
Biotechnology Analyst, Goldman Sachs

... Sheldon, is sort of, you know, as you think about the multi-year strategy, you have this commercial base, you have a nice partnership in the ex-U.S. markets. You know, you said you will start to turn the card a little bit over on your earlier stage pipeline. But as you think about the investment case over maybe a little bit of a longer term type timeline, excuse me, you know, where do you see the shape of the company, and sort of what is the, I guess, the value proposition that investors may or may not be getting at the moment as to where, let's say, Esperion could be in a few years?

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah, I think we're finally past, as I mentioned earlier, all the distractions that we've seen before. The one thing we've always stuck to is that everything that we've said that we were going to do, we've done and we've accomplished. We're going to keep doing that. We're going to grow these products to a blockbuster potential. That's going to allow us to, you know, high tide floats all boats, invest in what is a very exciting pipeline, and carry this company into the future of... Gets back to what I said earlier, really supplying drugs that are life-saving, not only today, but in the future, in a market that, to your point, has really starting to evolve and getting more attention in the cardiometabolic marketplace.

You know, we've got great products, and great products are the key to success in this industry after, you know, doing this for 34 years, so.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Great.

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah.

Paul Choi
Biotechnology Analyst, Goldman Sachs

Okay, we're coming up on time here, so we'll end it on that note. My thanks to Sheldon and Esperion.

Sheldon Koenig
CEO, Esperion Therapeutics

Thank you

Paul Choi
Biotechnology Analyst, Goldman Sachs

... for joining us. Thank you.

Sheldon Koenig
CEO, Esperion Therapeutics

Thank you so much.

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