Esperion at Goldman Sachs Conference: Charting a Path to Profitability

On Monday, 09 June 2025, Esperion Therapeutics (NASDAQ:ESPR) participated in the Goldman Sachs 46th Annual Global Healthcare Conference. The discussion, led by company executive Sheldon and analyst Paul Choi, highlighted Esperion’s strategic focus on commercial progress and pipeline expansion. While optimistic about future profitability, the company acknowledged challenges in patent litigation and market competition.

Key Takeaways

• Esperion aims for profitability by January 2026, driven by US sales growth and international partnerships.
• Medicare Part D redesign is enhancing patient access, improving approval rates.
• Expansion into liver disease with ESP one three three six and a new triple combination drug is underway.
• Otsuka partnership in Japan is expected to launch in the fourth quarter, with significant milestone payments anticipated.
• Patent protection discussions indicate potential coverage beyond 2031.

Commercial Performance and Reimbursement

• Esperion’s Nexlitol and Nexlazet are gaining traction, particularly among statin-intolerant patients.
• First-quarter growth was achieved in a flat market, with acceleration continuing into the second quarter.
• Medicare Part D redesign has reduced out-of-pocket costs, benefiting patient access and approval rates.
• Field reimbursement managers have improved approval rates from the low 70% range to the high 70% to low 80% range.

Pipeline Updates and R&D

• ESP one three three six is targeting primary sclerosing cholangitis (PSC), a severe liver disease, with promising phase three data.
• A triple combination drug is being developed for LDL lowering, leveraging Daiichi Sankyo’s bioequivalence study.
• The new drug aims to serve patients already taking a statin, with a small clinical study planned to enhance LDL data.

International Partnerships

• Otsuka’s dedicated team of nearly 700 people is preparing for a Japan launch in the fourth quarter.
• Up to $130 million in milestones are expected, contingent on pricing achieved from Japan’s Ministry.

IP Litigation and Patents

• Of nine ANDA filers, two have settled for April 2040.
• Esperion’s baseline patent expiry is set for June 2031, with considerations for extending protection beyond this date.

Future Outlook and Business Development

• Esperion is focused on growing the Nexlazet and Nexlitol franchise to achieve profitability by 2026.
• The company is exploring partnerships in the cardiometabolic area to leverage its existing infrastructure.
• Business development efforts are aimed at marketing and selling complementary drugs.

In conclusion, Esperion’s strategic initiatives and partnerships underscore its growth potential. For a detailed account, refer to the full conference transcript below.

Full transcript - Goldman Sachs 46th Annual Global Healthcare Conference:

Paul Choi, Analyst, Goldman Sachs: Good morning, everyone. We’ll continue with the next session, 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. 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 Yeah.

Sheldon, Executive, Esperion Therapeutics: Great. Well, of all, thanks, Paul. Really appreciate invitation to the Goldman Sachs meeting, and a lot better weather than we had last year. Definitely. With the rain.

Paul Choi, Analyst, Goldman Sachs: So this is great.

Sheldon, Executive, Esperion Therapeutics: As it relates to Esperion, Esperion has been an organization that’s been around really since 02/2008, but when we really came on the map was probably in 2020 when the drugs, both Nexlitol and Nexlazet 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 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 twenty fourth of this year, we had an R and D day where we actually introduced an asset, ESP one three three six. 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 Asperion 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 and 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, Analyst, Goldman Sachs: Okay, great. Maybe let’s start with the commercial side of things. And you referenced the risk reduction label change 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 uptake? And maybe on the flip side of that, what are sort of the resistant points about adopting Nexlotol or Nexlazet?

Sheldon, Executive, Esperion Therapeutics: Yeah, sure. I think, 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 and primary prevention. And that is something that has really resonated with primary care physicians and also cardiologists. Quarter, we had a really good quarter in the first quarter.

We actually demonstrated growth in a 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 resonating is primary prevention, but the other thing is the statin intolerance message. So we’ve been really establishing a beachhead in statin intolerance.

You know, the NLA came out in about mid February and said up to thirty percent 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 were 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 non prescribers these are people who have never written the drug at an all time high. So it’s pretty amazing to see after five years of the 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 wanna 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 gonna 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 Nexlitol. Maybe just for clarification, people may be familiar with ACC or but what is the NLA? For those

Paul Choi, Analyst, Goldman Sachs: of us who may not be in the lipidology field.

Sheldon, Executive, Esperion Therapeutics: Yeah, sure. So the NLA is Association. They work very closely with the and ACC. Many of their board members and directors are all members of the and ACC. So we had a meeting, I wanna say it was in Miami.

I missed it two weeks ago.

Paul Choi, Analyst, Goldman Sachs: Okay. Great. And they also issue guidelines similar to to ACC? They absolutely do. Okay.

Great. Thank you. Maybe one thing, you know, to to help help us think about Asperion and is just, you know, think about both reimbursement on the commercial side as well as the MedicareMedicaid 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, Executive, Esperion Therapeutics: 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, etcetera, as it relates to adoption, it was really these lengthy prior authorizations and step edits. Keep in mind, before clear outcome study, we had a TAM of about 10,000,000. Post outcomes, we had a TAM of 70,000,000.

And 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. And there’s no step at it. In the remainder of plans, it’s a very simple prior authorization of has this patent has this patient actually tried the statin?

And all it takes is the physician to do an electronic look back of six 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, etcetera. By the way, we have 193,000,000 lives covered in that seventy two percent 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 doughnut hole was later in the year, in the third or fourth quarter.

Mhmm. This year, there’s 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 were even gonna have Medicare because there’s a lot of rhetoric from DC. And there’s a lot of them 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 zero 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. About a three

Paul Choi, Analyst, Goldman Sachs: to six month pull forward, roughly speaking, all of the beginning. And just as a reminder, the the $2,000 you you referenced is not specific to Nexlotol and Nexlazette. It’s across all Medicare drugs. Correct?

Sheldon, Executive, Esperion Therapeutics: It’s across all Medicare drugs. And what you see patients do typically is for non symptomatic drugs, like for what we do, they really prioritize their symptomatic drugs So things for pain. Also, if they’re taking a drug like an antiplatelet, etcetera, diabetes drugs, they’ll prioritize those That gets them through the donut hole, and then that lessens their out of pocket expense for drugs like Nexlazeta and Nexlitol.

Paul Choi, Analyst, Goldman Sachs: Okay. Great. And then just you you talked a little bit about about the pull forward here of the lower out of pocket cost for patients here, 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 in the back half of the year?

Sheldon, Executive, 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 the messaging that we give to our physicians. They can see it.

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

Paul Choi, Analyst, Goldman Sachs: Great. You recently announced an an expansion of of your sales field force. How much of that was sort of principled 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 Salesforce expansion to start happening? And, you know, I I guess, you know, show in in tangible ways and then be accretive to to your revenue.

Sheldon, Executive, Esperion Therapeutics: Sure. So last year in January, we extended our Salesforce by about 72 additional people, which gave us a total of a 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 Asperion. 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 doctor’s offices. They understand prior authorizations, step edits, etcetera. 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 second 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, etcetera.

How we measure them is number of approvals. And I can tell you our approval rates in both commercial and Medicare were in these low seventies. We’re in the high seventies to low eighties right now.

Paul Choi, Analyst, Goldman Sachs: K.

Sheldon, Executive, Esperion Therapeutics: And I view that as a result of them being out there.

Paul Choi, Analyst, Goldman Sachs: Okay. So you’ve already seen since April a roughly low double digit improvement Yes. Versus where you were baselining prior to that? Correct. 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? Just is that something you wanna build on further at at this point, or just kinda see see how it goes, I guess, for the next year?

Sheldon, Executive, Esperion Therapeutics: Yeah. I think what we wanna do is we know going from six to 15 made sense because six 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 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.

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.

Paul Choi, Analyst, Goldman Sachs: Okay. Great. You talked a little bit about your performance in 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 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 are also some clinical stage assets.

But I guess, in my mind, this is probably one of the more exciting times in sort of the cardiology field, lipids lowering field, we’ve seen in many, many years. And so as you think about the landscape, you’re 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 Asperion’s portfolio?

Sheldon, Executive, Esperion Therapeutics: Yeah. And I’ll try to make this quick, because this is something I could speak about for an hour. 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 many of these targets. LP with LA, 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 were 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 is not an identified or recognized biomarker by the FDA, so it’s very difficult to really understand what will LP little a show us.

And is it for just a certain type of patient? I mean, you look at the Horizon data, it’s not really the same cardiovascular type of patient as what we have in our outcomes study. So it really remains to be seen. If I look at the OHDSI and Fourier study, the PCSK nine 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 fifteen percent. Both of those drugs reduced Lp, one could say it had no further effect over and beyond what was shown in OddiSY and Fourier.

So that’s really the only surrogate that we can look at. I’ll be selfish and say for Nexlazeta Nexlitol, we reduced hSCRP by twenty two percent. And if you go back to 02/2017, Novartis did a study specifically looking at lowering h s c r p and showed a 15% reduction in MACE driven events. Twenty seven percent of that was in heart attacks alone. So hsCRP is a recognized biomarker.

It’s something that we do. And obviously, if combined with a statin, they also do. So Lp 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 generation CETP coming out. Four 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, think what no one’s talking about is in the supplement. You did see an increase in blood pressure of OV versus placebo, and 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 of 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 three data. We’ll wait and see what that says at But I think the oral oral PCSK9. Sorry. Oral PCSK9. I think the issue there is you have to fast eight hours, take the drug, then wait thirty minutes.

And I don’t know about you, but when I wake up in the morning, I’m hungry and I wanna eat. So I think that’s gonna be I think that’s gonna 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.

Paul Choi, Analyst, Goldman Sachs: K. Great. I’ll talk a little bit about your your your partnership 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, what is the rough time line 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, Executive, Esperion Therapeutics: Yeah. So Osaka 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 Aspirone, we have 305 people in The United States.

We’ve been 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’ll be in the fourth quarter. We have up to a $130 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 01/2026, we’ll be profitable. That’s a big statement for us considering where we were last year.

So I just wanna get that quick commercial in. But Otsuka, super excited about it. They’re excited. It’s the largest lipid lowering market, and many of those patients also cannot take a statin. I think the best analogy is ezetimibe, a drug I managed for four years, and that was a big market for us at Merck, and it’ll be a big market for us also here at Esperion.

Paul Choi, Analyst, Goldman Sachs: Okay. Great. And then just maybe related to that, your your top line or sorry. Your your milestones are triggered by by the approval and then presumably down the road sales and sales milestones

Sheldon, Executive, Esperion Therapeutics: are It’s actually based upon the language that we have in The US label, which, as you know, based upon outcomes, which is in The US label. The larger portion of the milestone is based upon the pricing that they can actually achieve from the Ministry of Japan. And we we feel very confident that that price will be on the higher tier based upon what we know. Great.

Paul Choi, Analyst, Goldman Sachs: Beyond the milestones, I guess, as you think about your international market opportunities with both Otsuka in Japan and DSC 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 five to five to ten year view?

Sheldon, Executive, Esperion Therapeutics: I think it is 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 three to five years, this is one of the largest markets in the world, lipid lowering therapy. We talked about the TAM of seventy million patients. We’ve talked about the fact this is the number one killer in the world more so than cancer.

And there’s so many patients in need, and there’s so much more science. Mean, even the work that we’re doing with our life cycle management and the development of a triple combination, I think we’ll we might get into our IP later. I think the sky’s the limit as far as growth for these products. And we’ve always said that we believe we have an asset that’s $1,000,000,000 plus in The United States, and we firmly believe that. Okay.

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

Sheldon, Executive, Esperion Therapeutics: Yeah. So, you know, we thought we really weren’t gonna 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 twenty forty. Then a filer came along and asked to settle, which was also around April of twenty forty. 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.

So, you know, we continue to, you know, watch and wait. We’re ready for the litigation. So out of the nine, two 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. Okay.

Paul Choi, Analyst, Goldman Sachs: Just sort of the know how of Exactly. How to is is not more than than just a just a small molecule. That’s correct. Okay. Great.

I wanna shift gears maybe a little bit and talk about your your r and d day where you you talked about PSC as as an indication here that you’re going to pursue as sort of your 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. PSC. PSC.

Excuse me. Yeah. And just sort of what what the basic, you know, high level biology here so that justifies picking this as your non cardiology indication.

Sheldon, Executive, Esperion Therapeutics: 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 to polycystic kidney disease, etcetera. We’ll talk about that more.

We pick 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. And I am not as bright as Steve Pankowski. You saw him present this data, and he is, you know, off the charts, 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 two liver transplants. The woman who runs the PSC coalition, her son has PSC, is a teenager.

This disease leaves the leads the transplantation. We believe we have a drug that can potentially maybe cure the disease, postpone having a transplantation, etcetera, 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 were talking to 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. But liver and kidney look good, and people wanna understand more about it. And that was also one of the, you know, reasons of of doing that R and D day as well.

Paul Choi, Analyst, Goldman Sachs: Great. Maybe just to keep on the thread here of PSC, in terms of how hepatologists look 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 as sort of the rescue budget sort of in between diagnosis and maybe getting to transplantation, how are these patients managed?

Sheldon, Executive, Esperion Therapeutics: Yeah. Well, there’s 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’s 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 a temporary a temporary fix. You know, we heard one patient that was presented that’s had to go through that three times.

This drug also has comes with a lot of itching and plaque psoriasis, etcetera. 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, etcetera. 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, you know, 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. Right.

Paul Choi, Analyst, Goldman Sachs: 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, Executive, 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. And, 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 it come out, along with drugs like maybe that Madrigal has and others. So 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. 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 to the market, and there’s a need for it.

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

Sheldon, Executive, Esperion Therapeutics: Yeah. So the timeline that we put out there was sometime in the early twenty thirties. We would like to do something before that. What I can say we 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, 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 a race to do everything that we need to do to get to clinic. And I would say stay tuned.

We’re gonna update everyone more as we get to the later half of third quarter.

Paul Choi, 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 DSC. 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 gonna 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, Executive, Esperion Therapeutics: Yeah. The biggest change was the fact that we didn’t have to do a clinical study. We only need a bioequivalence study in The United States, and we’re able to use the bioequivalence 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. Cadaway 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’s 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, and it’s a plain convenience. So now you have three pills that you can just take in one. It also gives the flexibility of the physician to say, I might just wanna use Nexletol. I might just wanna use Nexlet, or I can now use the triple combination. I think the beauty of it is it could be the potentially the most efficacious LDL lowering drug on the market in one pill, and we’re excited about it.

We actually have a lipid advisory board meeting coming up June. These are all the high level lipid folks in The United States. Mhmm. We’ll be talking about this. And we are also gonna think about is there some clinical information that potentially we could put into the label if we did a a small study?

Yep. So we’ll keep everyone updated on that as well.

Paul Choi, 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 on label for for this package here versus just, bioequivalence? And, just sort of do you feel like that’s a necessary step in your clinical development?

Sheldon, Executive, Esperion Therapeutics: 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 two that looked at the addition of atorvastatin plus azetimibe plus memphidoic acid, which showed almost a 70%, 70% LDL lowering. You can’t use that in promotion, but if you could do a small study, that then it gives you something to talk about, but it’s not necessary at all.

Okay.

Paul Choi, Analyst, Goldman Sachs: 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, Executive, Esperion Therapeutics: Yeah. It’s really for those patients who are already taking a statin. And it allows the doctor to say, wow. You know, I’ve already had experience with Nexlotol. I have experience with Nexlotol.

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 mock ups of it.

So to me, it’s just a continuation of of the franchise. You know, there’s some physicians out there that just don’t wanna 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 three 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 they 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 Nexlocet. By the way, our new tagline with physicians, so they remember sometimes is that can’t take a statin, make Nexlocet happen, and that really resonates. Now, you know, we’ve 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. Okay.

Paul Choi, Analyst, Goldman Sachs: Would there be any potentially new IP associated with the with the fixed dose combination here beyond the the sort of 20 forties that we had talked about with earlier in your litigation?

Sheldon, Executive, Esperion Therapeutics: Not in The United States. Okay. But in Europe, we think there is, and that’s something we’re still researching.

Paul Choi, Analyst, Goldman Sachs: 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 Asperion 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 potentially down the road. How do you think about BD maybe?

Sheldon, Executive, Esperion Therapeutics: Yeah. So our number one focus is really growing the franchise of Nexlazet and Nexlitol. 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’ve either filed the drug, they’re waiting for approval, they’re about to file. Nothing in the clinic. We don’t wanna take risk and do that. The, I would say, silver lining in the macro environment that we have today is it costs 80 to a $100,000,000 to 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 wanna make sure it’s the right drug. And, you know, we feel good about where we are in the stage, and we’ll continue to update folks on our progress there.

Paul Choi, Analyst, Goldman Sachs: Okay. Great. We just hit time. So my my thanks to Sheldon and Chris Curian for joining us. Thank you so much, Paul.

Thank you.

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