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

June 9, 2025

NASDAQ US Health Care Pharmaceuticals conference_presentation 35 min

Earnings Call Speaker Segments

Kyuwon Choi

analyst
#1

Okay. 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 commercial prospects as well as the recent pipeline updates that they talked about at their analyst event. And so maybe 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

executive
#2

Yes, great. Well, first of all, thanks, Paul. Really appreciate the invitation of the Goldman Sachs meeting and a lot better weather than we had last year with the rain, so this is great. As it relates to Esperion, Esperion has 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 Outcomes study, which is a 14,000 patient outcome study. It was presented at ACC in 2023. We had a new label that came out in 2024. We'll talk more about that specifically. We also -- on April 24 of this year, we had an R&D Day where we actually introduced an asset, ESP-1336. This is for primary sclerosing cholangitis, a very severe liver disease. It's an orphan disease. We're excited about this. And what I say about Esperion is we're one of the few small to midsize cap organizations that is not only commercializing a drug, but we also have a very interesting pipeline and a quick commercial will be at Bio next week in Boston. We have a very full dance card, which we're excited about that as well.

Kyuwon Choi

analyst
#3

Okay. Great. Maybe let's start with the commercial side of things and you referenced the risk reduction label changed last year. And so now that it's been a little bit of time. Can you maybe tell us what has resonated the most with prescribers, either at the cardiology specialty side or in the general practitioner suite and in terms of uptick. And maybe on the flip side of that, what are sort of the resistance points about adopting NEXLETOL and NEXLIZET?

Sheldon Koenig

executive
#4

Yes, 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. And that is something that's 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. And 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. So what's resonated as primary prevention, but the other thing is the statin intolerance message. So we've been really establishing a beachhead in statin intolerance. 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, and we went to them simply with that message. Doctor, I know you have patients who cannot take a statin. And we've seen an adoption of nonprescribers. These are people who have never written the drug at an all-time high. So it's pretty amazing to see after 5 years, with a new drug being out there that new physicians are writing the drug. So we're getting breadth. And 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. So we're really establishing that beachhead every week. We're seeing an increase of the amount of new physicians and I think we're going to continue to see that. And then we'll continue to move across our segments. And again, for those patients who can take a statin, but cannot take a therapeutic dose, add NEXLIZET or NEXLETOL.

Kyuwon Choi

analyst
#5

Maybe just for clarification, people may be familiar with ACC or AHA, but what is the NLA? Yes, who may not be in the lipidology don't...

Sheldon Koenig

executive
#6

Sure. So the NLA is the National Lipid Association. They worked 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 2 weeks ago.

Kyuwon Choi

analyst
#7

Okay. Great. And they also issued guidelines similar to ACC and AHA.

Sheldon Koenig

executive
#8

They absolutely do.

Kyuwon Choi

analyst
#9

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

Sheldon Koenig

executive
#10

Sure. Absolutely. And I think just to give a little detail before that because going back to your last question of what were some of the speed bumps, et cetera, as it relates to adoption. It was really these lengthy prior authorizations and step edits. Keep in mind, before CLEAR Outcomes study, we had a TAM of about 10 million. Post outcomes, we had a TAM of 70 million. And we knew once we have the outcome study, we could go to commercial providers and Medicare providers and readdress some of these prior authorizations and burdensome step at it. 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. And there's no step at it. In the remainder of plans, it's a very simple prior authorization of has this patient actually tried the statin, and all it takes is a physician to do an electronic look back of 6 months to see if they've done -- 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. So we are not disadvantaged to anyone. As it relates to the IRA effects, so 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. And what you had this year in the first quarter were patients wondering if they're even going to have Medicare because there's a lot of rhetoric from DC. And there's a lot that didn't understand their out-of-pocket costs. What we see now in the second quarter most patients have gone through this $2,000 donut hole, and we're seeing 0 co-pay for many patients. At the very least, they might have to pay $30 or $35 and we didn't see $30 or $35 co-pays in Medicare patients until September, typically. We're seeing it now. So we see a nice tailwind here as it relates to Medicare and reimbursement from a Medicare perspective.

Kyuwon Choi

analyst
#11

About a 3- to 6-month pull forward roughly speaking, all of these?

Sheldon Koenig

executive
#12

Yes.

Kyuwon Choi

analyst
#13

And just as a reminder, the $2,000 you referenced is not specific to NEXLETOL and NEXLIZET. It's across all Medicare drugs, correct?

Sheldon Koenig

executive
#14

It's across all Medicare drugs. And what you see patients do typically is for nonsymptomatic drugs like for what we do, they really prioritize their symptomatic drugs first. So things for pain, also after taking a drug like an anti-platelet, 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.

Kyuwon Choi

analyst
#15

Okay. Great. And then just 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 drug? And just does that accelerate uptake, I guess, in the back half of the year?

Sheldon Koenig

executive
#16

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. So we, again, view it as a tailwind for us.

Kyuwon Choi

analyst
#17

Okay. Great. You recently announced an expansion of your sales field force. 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? And when do you expect sort of the payoff from the sales force expansion to start happening? And I guess, show intangible ways and be accretive to your revenue?

Sheldon Koenig

executive
#18

Sure. So 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 5 medical science liaisons as well as strategically placed. What we also did is we expanded most recently, we went from 6 field reimbursement managers to 15. Why did we do that? We have 15 regions across the country, we dedicated 1 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. And 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 2 of this year. And I can tell you we're already seeing the dividends pay off. Now 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. But I can see even in the trends for this quarter that there's something different that's happening, and we think it's a result of these field reimbursement managers. Now we have to be careful how we measure them from a compliance perspective, et cetera. How we measure them is number of approvals. And I can tell you, our approval rates in both commercial and Medicare were in the low 70s, we're in the high 70s to low 80s right now. And I view that as a result of them being out there.

Kyuwon Choi

analyst
#19

Okay. So you've already seen since April, roughly low double-digit improvement versus where you were baselining prior to that?

Sheldon Koenig

executive
#20

Correct.

Kyuwon Choi

analyst
#21

Okay. Interesting. And then 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. And just 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

executive
#22

Yes. I think what we want to do is we know going from 6 to 15 made sense because 6 couldn't cover the whole country. So we definitely think the investment of 15 is the right investment. I don't see adding any more. And I think there's actually a time, too, just from an 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. And I will say it's -- this is the easiest it's been. That was always the issues years ago, but now it's gotten a lot easier. And I think that for the next -- at least for this year, we'll keep the 15 and maybe even further.

Kyuwon Choi

analyst
#23

Okay, great. You talked a little bit about your performance and gaining share in the first quarter in what was otherwise a flat market. First quarter is always a little bit tricky because of the turnover of the calendar and so forth. But 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 in the market and there also some clinical stage assets. But I guess, in my mind, this is probably 1 of the more exciting times in sort of the cardiology field, lipid lowering field that we've seen in many, many years. And so as you think about the landscape, probably mindful of competing agents coming down the line. And so maybe one of the targets I want to address here briefly is LPA, just maybe share your high-level thoughts on LPA as a target. And then as you think about the various clinical stage assets that are out there, how does their potential competitive positioning look versus Esperion's portfolio?

Sheldon Koenig

executive
#24

Yes. And I'll try to make this quick because this is something I can speak about for an hour. I'm very passionate about this. And 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 many of these targets. Lp(a), I think, is very interesting. We really need to see, I think, what the HORIZON study shows. That's the Novartis study, as you are aware, we are supposed to see those results this year. We won't see them until 2026 at some point because they just didn't have enough events is what we've been told publicly. Lp(a) is not an identified or recognized biomarker by the FDA. So it's very difficult to really understand what will Lp(a) show us, and 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 is what we have in our Outcomes study. So 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 the 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. So that's really the only surrogate that we can look at. I'll be selfish and say for NEXLIZET and NEXLETOL, we reduced hsCRP by 22%. And if you go back to 2017, Novartis did a study specifically looking at lowering hsCRP and showed a 15% reduction in MACE-driven events. 27% of that was in heart attacks alone. So hsCRP as a recognized biomarker is something that we do. And obviously, if combined with the statin, they also do. So Lp(a) remains to be seen, and we'll just have to wait and see what the data shows. As it relates to competition, obviously, we have a fifth generation CETP coming out, 4 previously have failed. And again, we really won't know the results. With the exception of the fact, we did see some results presented at EAS. And just high level, I think what no one is talking about is in the supplement you did see an increase in blood pressure of OV versus placebo. And you also saw 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. And then lastly, CETP inhibition, we saw some news today that Merck has finished some of their Phase III data. We'll wait and see what that says at AHA. But I think the oral PCSK9. I think the issue there is you have to fast 8 hours, take the drug then wait 30 minutes and I don't know about you, but when I wake up, the more I'm hungry and I'm want to eat. So I think that's going to be commercially very difficult. But 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.

Kyuwon Choi

analyst
#25

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

Sheldon Koenig

executive
#26

So Otsuka based in Japan, is commercializing the drug in Japan has been filed. They have close to 700 people dedicated to this product. You think about Esperion, we have 305 people in the United States. 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 United States, there's no PDUFA for Japan. So we think it will be in the fourth quarter. We have up to $130 million in milestones that will be paid to us. And I mentioned this about a week ago, but it's a good time to fit it in. Even without the milestones, we believe in 1Q 2026 will be profitable. That's a big statement for us considering where we were last year. So I just want to get that quick commercial in. But Otsuka, super excited about it, very excited. It's the third largest lipid lowering market. And many of those patients also cannot take a statin. I think the best analogy is ezetimibe, a drug I manage for 4 years, and that was a big market for us at Merck and it will be a big market for us also here at Esperion.

Kyuwon Choi

analyst
#27

Okay. Great. And then 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

executive
#28

It's actually based upon the language that we have in the U.S. label, which, as 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 price will be on the higher tier based upon what we know.

Kyuwon Choi

analyst
#29

Great. beyond the milestones, I guess, as you think about your international market opportunities with both Otsuka in Japan and DSE in Europe, just -- 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 5- to 10-year view?

Sheldon Koenig

executive
#30

I think it simply said, it just continues to go up. And even looking at current lipid-lowering drugs that are on the market. You continue to see a growth of these drugs. Again, first quarter was flat for a number of reasons. But overall, if you look at 3 to 5 years, this is one of the largest markets in the world, lipid-lowering therapy. We talked about the TAM of 70 million patients. We've talked about the fact this is the #1 killer in the world, more so than cancer. And there's so many patients in need and there's 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 our IP later. I think the sky is the limit as far as growth for these products. And we've always said that we believe we have an asset that's $1 billion plus in the United States, and we firmly believe that.

Kyuwon Choi

analyst
#31

Okay. Maybe just since you brought on IP, you guys have been in a series of -- with some generic filers. There are a few outstanding, however, maybe just can you remind us 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

executive
#32

Yes. So we thought we really weren't going to have much insight into what was happening with the IP until the ANDA litigation began in 2027. And then we had one of the filers actually settle, as you mentioned, for April of 2040. Then the second filer came along and asked to settle, which was also around April of 2040 remains to be seen. What happens to others, we'll 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, but it simply for so many reasons. And we're starting to think about what that planning would look like. So we continue to watch and wait. We're ready for the litigation. So out of the 9, 2 have settled, again, we'll see if there's more but we've always believed in the strength of our patents. This drug is difficult to make. It's dangerous to make. And we know how to do it, others don't. So -- and I think that's what people are focusing on and seeing.

Kyuwon Choi

analyst
#33

Just sort of the know-how of...

Sheldon Koenig

executive
#34

Exactly.

Kyuwon Choi

analyst
#35

How to not more than just a small molecule.

Sheldon Koenig

executive
#36

That's correct.

Kyuwon Choi

analyst
#37

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 how does CETP translate here into a liver disease -- sorry...

Sheldon Koenig

executive
#38

PSC.

Kyuwon Choi

analyst
#39

PSC, excuse me. And just sort of what the basic high-level biology here that justifies picking this as your first non-cardiology indication?

Sheldon Koenig

executive
#40

Sure. So one thing about ACLY biology is that it has 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 can range anywhere from CKD, the 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 effect on fibrosis, there's an effect on inflammation and there's an effect on healing the injury. And I am not as bright as Steve Pinkosky, you saw him present this data, and he is off the chart smart. But as he always says, we have found kind of this intersection between cell metabolism and fibrosis. And just talking 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 2 liver transplants. The woman who runs the PSC coalition, her son has PSC, is 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, but we're also looking for ways to expedite the timeline, the timeline that you saw presented on April 24. So more to come on that. But it just really demonstrates how unique ACLY biology is. And I can tell you, and just coming back to the commercial I did earlier for Bio folks that reached out to us that we're talking to in bio were very interested in that presentation and the science surrounding ACLY biology. I 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 geoblastoma, but that's very early. But liver and kidney look good, and people want to understand more about it. And that was also one of the reasons of doing that R&D Day as well.

Kyuwon Choi

analyst
#41

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 that progresses to transplantation is sort of the rescue but just sort of in between diagnosis and maybe getting to transplantation how are these patients manage?

Sheldon Koenig

executive
#42

Yes. Well, there's not a lot right now to manage it. And there are -- I think a lot of this is experimental use of different drugs. There's also a mechanical way, which is 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. We heard 1 patient that was presented that's had to go through that 3 times. This drug also has comes with a lot of itching and plaque psoriasis, et cetera, so you've got to use drugs to control that. And it's not like a simple itch. We heard that you can itch from the top of your throat all the way down to your feet, et cetera. So there's just a lot of nasty side effects where you have to use a lot of different drugs. But I don't think anything right now really kind of stops that march towards liver transplantation. And that brings me back again to ACLY biology gets you to look at the fibrosis that causes it do something around the injury, do something around the inflammation. We think that probably has something to do with hsCRP. And so those are the important elements that have been missing before to treat the disease.

Kyuwon Choi

analyst
#43

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 landscape potentially affect you guys? Is that completely -- is it adjacent? Or is it overlapping at all?

Sheldon Koenig

executive
#44

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. And right now, I think everyone is still waiting to see -- obviously, you have the Madrigal drug out there that seems to be doing well, that's focused on MASH. I think it's something that can be used by physicians, our drug, should it come out, along with drugs like maybe that Madrigal has and others. So it's something over and beyond MASH. MASH was an option that we thought about, but we actually felt that is an area that is a bit crowded right now and 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, and there's a need for it.

Kyuwon Choi

analyst
#45

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

Sheldon Koenig

executive
#46

Yes. So 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. It remains to be seen if we would have to do an Outcomes study, our understanding right now is that we wouldn't, and 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. And I would say stay tuned. We're going to update everyone more as we get to the latter half of third quarter.

Kyuwon Choi

analyst
#47

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, DSE, but now you're talking more about development here for -- more recently talking about development for the domestic market. Can you maybe just 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

executive
#48

Yes. 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, and 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 both across therapeutic areas. [indiscernible] was an example, Merck tried to do it with ZOCOR and JANUVIA, it just didn't mix. But physicians are ready to use a polypill where it addresses the same therapeutic area, in this case, LDL lowering. And the formulation is unique because it's with a low-dose statin, again, keen in on the fact that patients really can't tolerate higher doses of statin, and it's a play on convenience. So now you have 3 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 a triple combination. I think the beauty of it is it could be the -- potentially the most efficacious LDL lowering drug on the market in 1 pill. And we're 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'll be talking about this. And we are also going to think about is there some clinical information that potentially we could put into the label if we did a small study, so we'll keep everyone an update on that as well.

Kyuwon Choi

analyst
#49

Okay. Do you feel like just on that last point, a small clinical studies 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

executive
#50

It's not a necessary step. It's more of a life cycle management consideration. It would give a little more data for somebody to speak about. Remember, there was some data that was done in Phase II that looked at the addition of atorvastatin plus ezetimibe plus bempedoic acid, which showed almost a 70%, 70 percent 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.

Kyuwon Choi

analyst
#51

Okay. Just as you think about what, at least in my mind, is a relatively low clinical development -- clinical risk development program here. And do you think 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

executive
#52

Yes. It's really for those patients who are already taking a statin and it allows the doctor to say, "Wow, I've 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? The pill size really isn't any bigger. We've seen some mockups of it. So to me, it's just a continuation of the franchise. 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. But I go back to about 3 years ago, we did behavioral research, and 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 it could use ezetimibe. And this is even with injectable PCSK9s out there, especially primary care physicians, and this is all we could do. And honestly, they just felt bad about that. They couldn't do more for their patients. We've changed that with NEXLIZET. By the way, our new tagline with physicians. So they remember sometimes is that can't take a statin, make NEXLIZET happen. And that really resonates. Now we've given them this kind of power to do more and to do something different that triple combination also helps them do that for the patient and make it easier for them.

Kyuwon Choi

analyst
#53

Okay. Would 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

executive
#54

Not in the United States. But in Europe, we think there is, and that's something we're still researching.

Kyuwon Choi

analyst
#55

Okay. Great. We're coming up on time here, and so maybe Sheldon to close it out, you've started talking about your next stage pipeline beyond cardiology as well as developing this triple combination. But as you sort of think about other next steps for Esperion here, how does BD figure in that potentially? Because 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

executive
#56

Yes. So our #1 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. So looking at obesity, high blood pressure, heart failure, even diabetes. And there's many companies out there that have some interesting products. They have 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. The -- I would say, silver lining in the macro environment that we have today that cost $80 million to $100 million of stand up a sales force like we have and have all the other support areas. We have the infrastructure. So 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". So we're doing that. We're having those conversations. We're not in any rush. We want to make sure it's the right drug. And we feel good about where we are in the stage, and we'll continue to update folks on our progress there.

Kyuwon Choi

analyst
#57

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

Sheldon Koenig

executive
#58

Thank you so much, Paul. Thank you.

For developers and AI pipelines

Programmatic access to Esperion Therapeutics, Inc. earnings transcripts and 32,000+ others is available through the EarningsCalls.dev REST API. Plans from $24.99/month — full transcripts, speaker segments, full-text search, and the recently-added /api/v1/transcripts/recent polling endpoint for ETL pipelines.