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Goldman Sachs 46th Annual Global Healthcare Conference

Jun 9, 2025

Paul Choi
Equity Research Analyst, Goldman Sachs

Good morning, everyone. We'll continue with the next session, which is Esperion Therapeutics. I'm Paul Choi, and I cover the biotech sector here at the firm. It's our pleasure to have Sheldon here with us once again this year to talk about Esperion and its commercial prospects, as well as the recent pipeline updates that they talked about at their analyst event. Maybe, you know, just to kick it off, Sheldon, for those who may be unfamiliar with Esperion, even though it's actually a company that's been around for a while and in a couple of different iterations, can you maybe just give us a little bit of background on the company?

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah, great. First of all, thanks, Paul. Really appreciate the invitation to the Goldman Sachs meeting and a lot better weather than we had last year.

Paul Choi
Equity Research Analyst, Goldman Sachs

Definitely. With the rain. This is great.

Sheldon Koenig
CEO, Esperion Therapeutics

As it relates to Esperion, Esperion's been an organization that's been around really since 2008, but when we really came on the map was probably in 2020 when the drugs, both Nexletol and Nexlizet, were launched. Since then, we've had some, I would say, really great achievements. We've had the launch of the CLEAR Outcome Study, which is a 14,000-patient outcome study. It was presented to ACC in 2023. We had a new label that came out in 2024. We'll talk more about that specifically. We also, on April the 24th of this year, we had an R&D day where we actually introduced an asset, ESP1336. This is for primary sclerosing cholangitis, a very severe liver disease. It's an orphan disease. We're excited about this.

What I say about Esperion is we're one of the few small to mid-sized cap organizations that is not only commercializing a drug, but we also have a very interesting pipeline. A quick commercial. We'll be at Bio next week in Boston. We have a very full dance card, which we're excited about that as well.

Paul Choi
Equity Research Analyst, Goldman Sachs

Okay, great. Maybe let's start with the commercial side of things. You referenced the risk reduction label change last year. Now that it's been a little bit of time, can you maybe tell us, you know, what has resonated the most with prescribers, either, you know, at the cardiology specialty side or in the general practitioner suite and in terms of uptake? You know, maybe on the flip side of that, what are sort of the resistance points about adopting Nexletol or Nexlizet?

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah, sure. I think, first of all, we are the only non-statin that has primary prevention. When you look at drugs today and even drugs that potentially could come out in the future, we own the airspace in primary prevention. That is something that has really resonated with primary care physicians and also cardiologists. First quarter, we had a really good quarter. In the first quarter, we actually demonstrated growth in the flat market. I can tell you in the second quarter through May, we're feeling really good about where we are. We've seen this acceleration, and we see that continuing. What's resonated is primary prevention, but the other thing is the statin intolerance message. We've been really establishing a beachhead in statin intolerance.

You know, the NLA came out in about mid-February and said up to 30% of patients cannot take a statin or do not want to take a statin. We actually did a small test. We went to physicians across the country who are not writing the drug. We went to them simply with that message, "Doctor, I know you have patients who cannot take a statin." We've seen an adoption of non-prescribers, these are people who have never written the drug, at an all-time high. It's pretty amazing to see after five years of a new drug being out there that new physicians are writing the drug. We're getting breadth. Of course, we're continuing to get depth from those who do write the drug. Why is it?

Because they do have patients that do not want to take a statin or they can only take a small dose of a statin. We are really establishing that beachhead. Every week, we are seeing an increase of the amount of new physicians. I think we are going to continue to see that. You know, we will continue to move across our segments. Again, for those patients who can take a statin but cannot take a therapeutic dose, add Nexlizet or Nexletol.

Paul Choi
Equity Research Analyst, Goldman Sachs

Just for clarification, people may be familiar with ACC or AHA, but what is the NLA?

Sheldon Koenig
CEO, Esperion Therapeutics

Oh, I'm sorry. Yes.

Paul Choi
Equity Research Analyst, Goldman Sachs

For those of us who may not be in the lipidology field.

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah, sure. The NLA is the National Lipid Association. They work very closely with the AHA and ACC. Many of their board members and directors are all members of the AHA and ACC. Recently had a meeting. I want to say it was in Miami. I missed it two weeks ago.

Paul Choi
Equity Research Analyst, Goldman Sachs

Okay, great. They also issue guidelines similar to ACC.

Sheldon Koenig
CEO, Esperion Therapeutics

They absolutely do.

Paul Choi
Equity Research Analyst, Goldman Sachs

Okay, great.

Sheldon Koenig
CEO, Esperion Therapeutics

Thank you.

Paul Choi
Equity Research Analyst, Goldman Sachs

Maybe one thing, you know, to help us think about Esperion is just, you know, think about both reimbursement on the commercial side as well as the Medicare/Medicaid side. Cardiology and lipid reduction is obviously a very large field. Statins are generic. You talked a little bit about the impact of the Medicare Part D redesign on your franchise. Can you maybe just remind us, you know, what was that sort of net impact to the degree you can quantify it? How do these Medicare design changes potentially affect your outlook over the near and intermediate term?

Sheldon Koenig
CEO, Esperion Therapeutics

Sure. Absolutely. I think just to give a little detail before that, because, you know, going back to your last question of what were some of the speed bumps, et cetera, as it related to adoption, it was really these lengthy prior authorizations and step edits. You know, keep in mind, before CLEAR Outcome Study, we had a TAM of about 10 million. Post-outcomes, we had a TAM of 70 million. We knew once we had the outcome study, we could go to commercial providers and Medicare providers and readdress some of these prior authorizations and burdensome step edits. If we just focus on Medicare alone, where we have about 72% adoption by Medicare plans, what we've seen in some of these plans, they've eliminated the prior authorization. It's gone. There's no step edit.

In the remainder of plans, it's a very simple prior authorization of, has this patient actually tried the statin? All it takes is a physician to do an electronic look back of six months to see if they've been on the statin. They don't have to put together a binder or a lot of evidence, et cetera. By the way, we have 193 million lives covered in that 72% Medicare coverage, which is all preferred. We are not disadvantaged to anyone. As it relates to the IRA effects, typically, as you know, the donut hole was later in the year, in the third or fourth quarter. This year, there was a lot of confusion with patients and Medicare providers. It was $2,000.

What you had this year in the first quarter were patients wondering if they were even going to have Medicare because there was a lot of rhetoric from D.C. There was a lot of them that did not understand their out-of-pocket costs. What we have seen now in the second quarter, most patients have gone through this $2,000 donut hole, and we are seeing zero copay for many patients. At the very least, they might have to pay $30 or $35. We did not see $30 or $35 copays in Medicare patients until September, typically. We are seeing it now. We see a nice tailwind here as it relates to Medicare and reimbursement from a Medicare perspective.

Paul Choi
Equity Research Analyst, Goldman Sachs

About a three- to six-month pull forward, roughly speaking, all of the people.

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah.

Paul Choi
Equity Research Analyst, Goldman Sachs

Just as a reminder, the $2,000 you referenced is not specific to Nexletol and Nexlizet. It is across all Medicare drugs, correct?

Sheldon Koenig
CEO, Esperion Therapeutics

It's across all Medicare drugs. What you see patients do typically is for non-symptomatic drugs, like for what we do, they really prioritize their symptomatic drugs first. Things for pain, also if they're taking a drug like an antiplatelet, et cetera, diabetes drugs, they'll prioritize those first. That gets them through the donut hole, and then that lessens their out-of-pocket expense for drugs like Nexlizet and Nexletol.

Paul Choi
Equity Research Analyst, Goldman Sachs

Okay, great. You talked a little bit about the pull forward here of the lower out-of-pocket cost for patients here, I guess. Does that, in your mind, open up or make it more easier, I guess, for patients to get on a drug? Does that accelerate uptake, I guess, in the back half of the year?

Sheldon Koenig
CEO, Esperion Therapeutics

It definitely makes it a lot easier for a patient to get the drug. They don't have to think about getting through that donut hole. They don't have to think about paying a lot of money. It also helps with the messaging that we give to our physicians. They can see it. We, again, view it as a tailwind for us.

Paul Choi
Equity Research Analyst, Goldman Sachs

Okay, great. You recently announced an expansion of your sales fields for us. How much of that was sort of principle by the or driven by the label change versus last year versus what you've now seen, I guess, in terms of the impact from the Medicare redesign here? When do you expect sort of the payoff from the sales force expansion to start happening? You know, I guess, you know, show in tangible ways and be accretive to your revenue.

Sheldon Koenig
CEO, Esperion Therapeutics

Sure. Last year, in January, we extended our sales force by about 72 additional people, which gave us a total of 155 sales folks across the country. We also have five medical science liaisons, as well as strategically placed. What we also did is we expanded most recently. We went from six field reimbursement managers to 15. Why did we do that? We have 15 regions across the country. We dedicated one field reimbursement manager to each region. What do they do? They're actually not employees of Esperion. It's actually a company we use, but we actually manage them. These are highly specialized individuals. They understand, many of them are nurses or have worked in doctors' offices. They understand prior authorizations, step edits, et cetera. They basically act as sharpshooters for representatives to call into an office that's having a problem getting the drug approved.

We rolled that out on April 2nd of this year. I can tell you, we're already seeing the dividends pay off. Much of this is qualitative because I get feedback from the field on almost a daily basis, including pictures, which I got last week of representatives and field reimbursement managers working together, getting to an office. I can see even in the trends for this quarter that there's something different that's happening. We think it's a result of these field reimbursement managers. We have to be careful how we measure them from a compliance perspective, et cetera. How we measure them is number of approvals. I can tell you, our approval rates in both commercial and Medicare were in the 70%-low 70%. We're in the high 70%-low 80% right now.

I view that as a result of them being out there.

Paul Choi
Equity Research Analyst, Goldman Sachs

Okay. So you've already seen since April, roughly low double-digit improvement.

Sheldon Koenig
CEO, Esperion Therapeutics

Yes.

Paul Choi
Equity Research Analyst, Goldman Sachs

Versus where you were baselining prior to that.

Sheldon Koenig
CEO, Esperion Therapeutics

Correct.

Paul Choi
Equity Research Analyst, Goldman Sachs

Okay. Interesting. In terms of, I guess, using that on the forward here, is that sort of going to be your standard practice here for this external reimbursement or prior authorization specialty team? Is that something you want to build on further at this point or just kind of see how it goes, I guess, for the next year?

Sheldon Koenig
CEO, Esperion Therapeutics

I think so. Yeah. I think what we want to do is we know going from six to 15 made sense because six could not cover the whole country. We definitely think the investment of 15 is the right investment. I do not see adding any more. I think there is actually a time too, just from the expense savings perspective, that we can back off once we have physicians really understanding across the country how easy it is to actually get the drug. I will say, this is the easiest it has been. That was always the issue years ago, but now it has gotten a lot easier. I think that for the next, you know, at least for this year, we will keep, you know, the 15 and maybe even further.

Paul Choi
Equity Research Analyst, Goldman Sachs

Okay, great. You know, you talked a little bit about your performance and gaining share in the first quarter and what was otherwise a flat market. First quarter is always a little bit tricky because of the turnover of the calendar and so forth. I guess just we've seen a few new products enter the market, such as yours in 2020, what had been The Medicines Company. Now Novartis is also, you know, in the market. There are also some clinical stage assets. I guess in my mind, this is probably one of the more exciting times in sort of the cardiology field, lipid lowering field that we've seen in many, many years. As you think about the landscape, you're probably mindful of competing agents coming down the line. Maybe one of the targets I want to address here briefly is Lp(a).

Just, you know, maybe share your high-level thoughts on Lp(a) as a target. And then, you know, as you think about the various clinical stage assets that are out there, you know, how does their potential competitive positioning look versus Esperion's portfolio?

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah. I'll try to make this quick because this is something I could speak about for an hour.

Paul Choi
Equity Research Analyst, Goldman Sachs

Sure.

Sheldon Koenig
CEO, Esperion Therapeutics

I'm very passionate about this. Having been in this field since really the early 2000s, I've seen a lot of drugs and worked on a lot of drugs and looked at, you know, many of these targets. Lp(a), I think, is very interesting. We really need to see, I think, what the Horizon study shows. That is the Novartis study, as you are aware. We were supposed to see those results this year. We will not see them until 2026 at some point because they just did not have enough events, is what we have been told publicly. Lp(a) is not an identified or recognized biomarker by the FDA. It is very difficult to really understand what will Lp(a) show us. Is it for just a certain type of patient?

I mean, if you look at the Horizon data, it's not really the same cardiovascular type of patient as what we have in our outcomes study. It really remains to be seen. If I look at the Odyssey and Fourier study, the PCSK9 studies, if you looked at their LDL reduction, you could go to the CTT analysis and predict what their residual risk reduction was, which was 15%. Both of those drugs reduce Lp(a), and one could say it had no further effect over and beyond what was shown in Odyssey and Fourier. That's really the only surrogate that we can look at. I'll be selfish and say for Nexletol and Nexlizet, we reduced hsCRP by 22%. If you go back to 2017, Novartis did a study specifically looking at lowering HS-CRP and showed a 15% reduction in MACE-driven events.

27% of that was in heart attacks alone. HS-CRP is a recognized biomarker. It is something that we do. Obviously, if combined with a statin, they also do. LP(a) remains to be seen, and we will just have to wait and see what the data shows. As it relates to competition, obviously, we have a fifth-generation CETP coming out where previously they have failed. We really will not know the results with the exception of the fact we did see some results presented at EAS. Just high level, I think what no one is talking about is in the supplement, you did see an increase in blood pressure of active versus placebo. You also saw in the TANDEM, I believe it was the TANDEM study, where you had to readjust or change hypertensive medications.

We know that's something that's out these products before, but again, we have to wait and see. Lastly, CETP inhibition, we saw some news today that Merck has finished some of their phase three data. We'll wait and see what that says at AHA, but I think the oral PCSK9, sorry, oral PCSK9, I think the issue there is you have to fast eight hours, take the drug, then wait 30 minutes. I don't know about you, but when I wake up in the morning, I'm hungry and I want to eat. I think that's going to be, I think that's going to be commercially very difficult. Look, I mean, focusing on our drug, as I said before, I like this concept of the airspace that we own.

We own primary prevention, and we also own the fact that you can take our drug with or without a statin.

Paul Choi
Equity Research Analyst, Goldman Sachs

Okay, great. I'll talk a little bit about your partnerships both in Europe and as well as in Japan. Your partner, Otsuka there, is in the midst of the regulatory process for an LDL lowering indication there. Can you maybe tell us, you know, first, you know, what is the rough timeline based on what you and your partner have discussed for launching there? Just, you know, sort of what is the lipid lowering or cholesterol market opportunity in Japan? Is it, you know, mostly genericized and just maybe help us understand sizing up that opportunity for you and your partner?

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah. So Otsuka, based in Japan, is commercializing the drug. In Japan, it's been filed. They have close to 700 people dedicated to this product. You know, you think about Esperion. We have 305 people in the U.S. We've been in the launch meeting. We were in Tokyo in December and met with them. They're super excited. We think that will happen sometime in the fourth quarter. Unlike the U.S., there's no PDUFA for Japan. We think it'll be in the fourth quarter. We have up to $130 million in milestones that will be paid to us. I mentioned this about a week ago, but it's a good time to fit it in. Even without the milestones, we believe in Q1 2026 we will be profitable. That's a big statement for us considering where we were last year.

We just want to get that quick commercial in. Otsuka, super excited about it. They're excited. It's the third largest lipid lowering market. Many of those patients also cannot take a statin. I think the best analogy is ezetimibe, a drug I managed for four years. That was a big market for us at Merck. It'll be a big market for us also here at Esperion.

Paul Choi
Equity Research Analyst, Goldman Sachs

Okay, great. Just maybe related to that, your top line, or sorry, your milestones are triggered by the approval and then presumably down the road sales and sales milestones.

Sheldon Koenig
CEO, Esperion Therapeutics

It's actually based upon the language that we have in the U.S. label, which is, you know, based upon outcomes, which is in the U.S. label. The larger portion of the milestones is based upon the pricing that they can actually achieve from the Ministry of Japan. And we feel very confident that that pricing will be on the higher tier based upon what we know.

Paul Choi
Equity Research Analyst, Goldman Sachs

Great. Beyond the milestones, I guess, as we think about your international market opportunities with both Otsuka in Japan and Daiichi Sankyo in Europe, just excuse me, maybe in broad strokes, as you think about next-generation lipid-lowering therapy development there, how does that adoption curve in your mind look maybe on a five - to 10-year view?

Sheldon Koenig
CEO, Esperion Therapeutics

I think it is simply said, it just continues to go up. Even looking at current lipid-lowering drugs that are on the market, you continue to see a growth of these drugs. Again, first quarter is flat for a number of reasons. Overall, if you look at three to five years, this is one of the largest markets in the world, lipid-lowering therapy. You know, we talked about the TAM of 70 million patients. We've talked about the fact this is the number one killer in the world, more so than cancer. There are so many patients in need. There is so much more science. I mean, even the work that we're doing with our life cycle management and the development of a triple combination, I think we might get into RIP later. I think the sky's the limit as far as growth for these products.

We've always said that we believe we have an asset that's $1 billion plus in the U.S. We firmly believe that.

Paul Choi
Equity Research Analyst, Goldman Sachs

Okay. Maybe just since you brought up IP, you guys have been in a series of some generic filers. There are a few outstanding, however. Maybe just can you remind us, you know, what have you settled and what are the terms on those settlements? And then for the ones with whom you remain in litigation, just sort of what sort of the next milestones or events we should look for might there be?

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah. So, you know, we thought we really weren't going to have much insight into what was happening with the IP until the end of litigation began in 2027. And then we had one of the filers actually settle, as you mentioned, for April of 2040. Then a second filer came along and asked to settle, which was also around April of 2040. Remains to be seen. You know, what happens to others, we'll, you know, just have to watch. But we've always planned for a baseline of our patent expiry to be 2031 in June. And I can sit here today and say we're actually thinking now beyond 2031. Anything beyond 2031 would be a real big deal for us, put it simply, for so many reasons. And we're starting to think about what that planning would look like.

You know, we continue to, you know, watch and wait. We're ready for the litigation. Out of the nine, two have settled. Again, we'll see if there's more. We've always believed in the strength of our patents. This drug is difficult to make. It's dangerous to make. We know how to do it. Others don't. I think that's what people are focusing on and seeing.

Paul Choi
Equity Research Analyst, Goldman Sachs

Okay. Just sort of the know-how of.

Sheldon Koenig
CEO, Esperion Therapeutics

Exactly.

Paul Choi
Equity Research Analyst, Goldman Sachs

How to is not more than just a small molecule.

Sheldon Koenig
CEO, Esperion Therapeutics

That's correct.

Paul Choi
Equity Research Analyst, Goldman Sachs

Okay. Great. I want to shift gears maybe a little bit and talk about your R&D day where you talked about PSC as an indication here that you're going to pursue as sort of your first expansion beyond lipid lowering and cardiology. Can you maybe at a high level walk us through, you know, how does CETP translate here into a liver disease? Sorry.

Sheldon Koenig
CEO, Esperion Therapeutics

Or PSC.

Paul Choi
Equity Research Analyst, Goldman Sachs

PSC, excuse me.

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah.

Paul Choi
Equity Research Analyst, Goldman Sachs

Just sort of what the basic, you know, high-level biology here is that justifies picking this as your first non-cardiology indication?

Sheldon Koenig
CEO, Esperion Therapeutics

Sure. One thing about ACLY biology is that it has, you know, very broad use is what we're finding. We introduced our liver program, as we've mentioned, in April. We also have a very extensive kidney program, which you'll hear about more next year, but that could range anywhere from CKD to polycystic kidney disease, et cetera. We'll talk about that more. We picked PSC because we believe with ACLY biology, you can actually see with the cell type that there's an effect on the liver bile ducts. There's an effect on fibrosis. There's an effect on inflammation, and there's an effect on healing the injury. I am not as bright as Steve Pinkowski. You saw him present this data, and he is, you know, off the chart smart. As he always says, we have found kind of this intersection between cell metabolism and fibrosis.

You know, just talk about PSC. This is a very, as you saw, this is a very terrible disease. It's an orphan disease. We were able to see a patient testimony who needed two liver transplants. The woman who runs the PSC coalition, her son has PSC as a teenager. This disease leads to transplantation. We believe we have a drug that can potentially maybe cure the disease, postpone having a transplantation, et cetera, early. We are also looking for ways to expedite the timeline, the timeline that you saw presented on April 24th. More to come on that. It just really demonstrates how unique ACLY biology is.

I can tell you, just coming back to the commercial I did earlier for BIO, folks that reached out to us that we were talking to them in BIO were very interested in that presentation and the science surrounding ACLY biology. You know, I've said we've had this effect on liver, kidney. We think we might have an oncology effect, but we're not experts there. We would need help there. There are several papers that were written on ACLY biology and glioblastoma, but that's very early. Liver and kidney look good. You know, people want to understand more about it. That was also one of the reasons of doing that R&D day as well.

Paul Choi
Equity Research Analyst, Goldman Sachs

Great. Maybe just to keep on the thread here of PSC in terms of how hepatologists look at the disease and currently treat or manage it, what are sort of the options there? Obviously, if a patient has severe disease, it progresses to transplantation as sort of the rescue, but just sort of in between diagnosis and maybe getting to transplantation, how are these patients managed?

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah, there is not a lot right now to manage it. And there, you know, I think a lot of it is experimental use of different drugs. There is also a mechanical way, which is, you know, very painful, very time-consuming, of actually going in and performing surgery and cleaning out the bile ducts. That seems to have a temporary fix. You know, we heard one patient that was presented that has had to go through that three times. This drug also comes with a lot of itching and plaque psoriasis, et cetera. So you have to use drugs to control that. And it is not like a simple itch. You know, we heard that you can itch from the top of your throat all the way down to your feet, et cetera. There are just a lot of nasty side effects where you have to use a lot of different drugs.

I do not think anything right now really kind of stops that march towards liver transplantation. That brings me back again to ACLY biology, gets you to look at the fibrosis that causes it, you know, do something around the injury, do something around the inflammation. We think that probably has something to do with hsCRP. Those are the important elements that have been missing before to treat the disease.

Paul Choi
Equity Research Analyst, Goldman Sachs

Right. One question that's come up is there are obviously, there's a commercial stage NASH drug as well as some clinical stage NASH drugs as well out there. And they target fibrosis, which is one of the key symptoms in PSC. How does that NASH ecosystem or landscape, you know, potentially affect you guys? Is that completely, is it adjacent or is it overlapping at all?

Sheldon Koenig
CEO, Esperion Therapeutics

I think it's, I think there is adjacent and overlapping maybe. I think there's definitely a partnership there because you're dealing with so many different liver-related diseases. You know, right now, I think everyone's still, you know, waiting to see. Obviously, you have the Madrigal drug out there that, you know, seems to be doing well that's focused on NASH. I think it's something that can be used by physicians. Our drug, you know, should have come out along with drugs like maybe that Madrigal has and others. It's something over and beyond NASH. You know, NASH was an option that we thought about, but, you know, we actually felt that is an area that is a bit crowded right now.

This was an area that was very specific to us that if you look at the regulatory timeline as well, it would be quicker to actually get to the market. There is a need for it.

Paul Choi
Equity Research Analyst, Goldman Sachs

Okay. Maybe since you just announced it at your R&D day, just sort of broad strokes, you know, when do you guys start in the clinic? What are rough timelines for the development program here in PSC? You know, what's the aspiration in terms of the timeline potentially to get to the market?

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah. The timeline that we put out there was sometime in the early 2030s. We would like to do something before that. What I can say is that we are exploring ways to do that. We do have a meeting that will be set up with the FDA where we'll discuss that. Remains to be seen if we would have to do an outcome study. Our understanding right now is that we wouldn't. I think that is something also that could bring speed to the market. Again, there's a real need for the drug. I think right now it's just a race to do everything that we need to do to get to clinic. I would say stay tuned. We're going to update everyone more as we get to the later half of third quarter.

Paul Choi
Equity Research Analyst, Goldman Sachs

Okay. Great. Maybe turning to other aspects of the pipeline. In the past, you had talked about developing a statin ezetimibe combination with bempedoic acid primarily for your European partner Daiichi Sankyo. Now you're talking more about development here for, more recently talking about development for the domestic market. Can you maybe just, you know, walk us through what has been the sort of change in your thought process? This was probably mostly going to be a partnered asset, but now you're thinking about doing this in-house and just sort of what was the logic or thought process there?

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah. The biggest change was the fact that we didn't have to do a clinical study. We only need a bioequivalent study in the United States. We're able to use the bioequivalent study that's actually being conducted by Daiichi Sankyo to do that. That was really it because we knew physicians were interested in it. There's always been this talk of polypill strategy. I think in the United States, there's been a failure in the past of combining drugs, but across therapeutic areas. CataWay was an example. Merck tried to do it with Zocor and Januvia. It just didn't mix. Physicians are ready to use a polypill where it addresses the same therapeutic area, in this case, LDL lowering. The formulation is unique because it's with a low-dose statin, again, keying in on the fact that patients really can't tolerate higher doses of statin.

It is a plan of convenience. Now you have three pills that you can just take in one. It also gives the flexibility of a physician to say, "I might just want to use Nexletol. I might just want to use Nexlizet, or I can now use the triple combination." I think the beauty of it is it could be potentially the most efficacious LDL lowering drug on the market in one pill. We are excited about it. We actually have a lipid advisory board meeting coming up end of June. These are all the high-level lipid folks in the United States. We will be talking about this. We are also going to think about, is there some clinical information that, you know, potentially we could put into the label if we did a small study?

Paul Choi
Equity Research Analyst, Goldman Sachs

Yeah.

Sheldon Koenig
CEO, Esperion Therapeutics

We'll keep everyone updated on that as well.

Paul Choi
Equity Research Analyst, Goldman Sachs

Okay. Do you feel like just on that last point, a small clinical study is required here just so you can actually show LDL data on label for this package here versus just bioequivalents? And just sort of do you feel like that's a necessary step in your clinical development?

Sheldon Koenig
CEO, Esperion Therapeutics

It's not a necessary step. It's more of a lifecycle management consideration. It would give a little more data for somebody to speak about. Remember, there was some data that was done in phase two that looked at the addition of atorvastatin plus ezetimibe plus bempedoic acid, which showed almost a 70% LDL lowering. You can't use that in promotion, but if you could do a small study, then it gives you something to talk about, but it's not necessary at all.

Paul Choi
Equity Research Analyst, Goldman Sachs

Okay. Just as you think about what, at least in my mind, is a relatively low clinical development risk, you know, clinical risk development program here, and as you think, you know, downstream to the commercial stage, how do you think about positioning this fixed dose triple combination versus your current portfolio? What is the messaging there versus your current portfolio?

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah. It's really for those patients who are already taking a statin. It allows a doctor to say, "Wow, you know, I already have experience with Nexlizet. I have experience with Nexletol. Hey, it might be easier for you, Johnny, to take this triple combination. Would you rather do that?" You know, the pill size really isn't any bigger. We've seen some mockups of it. To me, it's just a continuation of the franchise. You know, there are some physicians out there that just don't want to use combination therapies. We still have many physicians that like using ezetimibe with Nexletol and the statin. We don't really understand the behavior behind that. I go back to about three years ago, we did behavioral research. This is like the overall view. Physicians today are just very apathetic about treatment.

They felt that all they could do was use a statin and they could use ezetimibe. This is even with injectable PCSK9s out there, especially primary care physicians. This is all we could do. Honestly, they just felt bad about that. They could not do more for their patients. We have changed that with Nexlizet. By the way, our new tagline with physicians that they remember sometimes is that, "Can't take a statin, make Nexlizet happen." That really resonates. Now, you know, we have given them this kind of power to do more and to do something different. That triple combination also helps them, you know, do that for the patient and make it easier for them.

Paul Choi
Equity Research Analyst, Goldman Sachs

Okay. Will there be any potentially new IP associated with the fixed dose combination here beyond the sort of 2040s that we had talked about with earlier in your litigation?

Sheldon Koenig
CEO, Esperion Therapeutics

Not in the U.S.

Paul Choi
Equity Research Analyst, Goldman Sachs

Okay.

Sheldon Koenig
CEO, Esperion Therapeutics

In Europe, we think there is. And that's something we're still researching.

Paul Choi
Equity Research Analyst, Goldman Sachs

Okay. Great. We're coming up on time here. Maybe Sheldon, to close it out, you know, you've started talking about your next stage pipeline beyond cardiology as well as developing this triple combination. As you sort of think about other next steps for Esperion here, how does BD figure in that potentially? You talked about transitioning to profitability as early as the first quarter of next year. You can start to build cash and so forth potentially down the road. How do you think about BD maybe?

Sheldon Koenig
CEO, Esperion Therapeutics

Yeah. Our number one focus is really growing the franchise of Nexlizet and Nexletol. I've said this many times. We have been involved and have conducted a landscape analysis of products that are out there specifically in the cardiometabolic area. Looking at obesity, high blood pressure, heart failure, even diabetes. There are many companies out there that have some interesting products. They've either filed the drug, they're waiting for approval, they're about to file. Nothing in the clinic. We don't want to take risk and do that. I would say the silver lining in the macro environment that we have today, it costs $80 million-$100 million to stand up a Salesforce like we have and have all the other support areas. You know, we have the infrastructure. What we've already talked, what we've always talked about is how do we leverage our infrastructure?

We don't have to go out and buy anything. How do we leverage our infrastructure and say, "Hey, company X, we can market and sell this drug for you. And let's talk about what that deal would look like if we do that." We are doing that. We are having those conversations. We are not in any rush. We want to make sure it's the right drug. You know, we feel good about where we are in the stage. We will continue to update folks on our progress there.

Paul Choi
Equity Research Analyst, Goldman Sachs

Okay. Great. We just hit time. So my thanks to Sheldon and Esperion for joining us.

Sheldon Koenig
CEO, Esperion Therapeutics

Thank you so much, Paul. Thank you.

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