Esperion Therapeutics, Inc. (ESPR)
NASDAQ: ESPR · Real-Time Price · USD
1.910
0.00 (0.00%)
At close: Apr 24, 2026, 4:00 PM EDT
1.940
+0.030 (1.57%)
After-hours: Apr 24, 2026, 4:58 PM EDT
← View all transcripts

25th Annual Needham Virtual Healthcare Conference

Apr 13, 2026

Serge Belanger
Senior Analyst, Needham & Company

Hi, good morning. I'm Serge Belanger, one of the Healthcare Analysts at Needham. I want to welcome everybody on this Monday morning to Needham's 25th Annual Healthcare Conference. For our next session, we have Esperion Therapeutics, a company commercializing and developing products in the cardiometabolic space. From the company, we have the CEO, Sheldon Koenig, as well as the CFO, Ben Halladay. I'll hand it over to you gentlemen for a quick overview of the company, and then we'll jump to some Q&A.

Sheldon Koenig
President and CEO, Esperion Therapeutics

Sounds great. Well, thanks, Serge, and on behalf of everyone at Esperion Therapeutics, we really appreciate Needham filling us in here, doing a fireside chat, and appreciate all the investor meetings that we have throughout the day. Do a quick summary because I know we've been on this show before, if we can use those words, and we've come a long way. This has been a real turnaround for this organization, and I'll just start from maybe even just a year ago. Some of the things that we demonstrated going from 2025-2026, we showed 38% year-over-year growth in revenue, 34% growth year-over-year in TRPEs. Japan, one of our partners, which is the third largest market in the world, they launched in November. They're off to a great start.

We went to JP Morgan, and we presented Vision 2040, and essentially, Vision 2040 was three building blocks. The first is to maximize the bempedoic acid franchise to the $1 billion franchise we believe it is in the U.S. and globally. Two was around business development. We talked about partnerships, really lending our organization. Because we have a unique infrastructure where we're not as big as some of these bigger pharma companies, but we do all the things that they do. The third building block was our pipeline. Just to hop back to number two, about a month ago, we talked about our intent to acquire Corstasis Therapeutics, and this is for a drug called Enbumyst, and it is indicated for treating those patients who are suffering from congestive heart failure, and essentially it's a loop diuretic to offload fluid from those patients.

We just closed that deal, I think it was last week. Super excited about that. I think we're going to talk about that a little bit later. And then the third building block, our lead candidate, primary sclerosing for primary sclerosing cholangitis. We hope to be in the clinic by the end of this year, so very ambitious, but a goal that we believe we'll meet. And I think most importantly, something we've talked about very often, which Ben can speak to once we get to these questions, we're going to show that we will be profitable this year, and that's a huge milestone for us. So that's the brief summary on where we were and where we are today.

Serge Belanger
Senior Analyst, Needham & Company

Great. Maybe let's start with the Corstasis Therapeutics acquisition, since it's fresh in everybody's mind. Maybe just highlight Enbumyst, what it is and what unmet need it's seeking to address.

Sheldon Koenig
President and CEO, Esperion Therapeutics

Yeah. Great. Enbumyst, for those people watching, I have a little display here. This is how the drug is delivered. You've seen something similar to this for NARCAN, neffy, et cetera. Essentially what the patient does is they squirt this in their nose, and it allows them to go to the bathroom. It's a loop diuretic, and it's easy to use. That's what we've heard from every single key opinion leader that we've talked to, and we've started embracing all the key opinion leaders and the heart failure community as soon as we had announced our intent to acquire Corstasis. There's a true unmet need. One in four out of the close to 7 million patients that are out there suffering from congestive heart failure are being readmitted to the hospital within 30 days. Serge, I think we've talked about this before.

Hospitals, physicians, they're judged by readmission rates of heart failure. Matter of fact, it's one of the few therapeutic areas where there's actually a connection, and people are tied to monetary rewards, whether it be a physician's bonus, CMS funding for a hospital, et cetera. We believe we have an alternative here where patients can actually treat themselves at home and avoid going to the emergency room to be diuresed. As a matter of fact, almost 80% of patients who leave the hospital after going in to be diuresed, they're still what is called wet. They still need further offloading of fluid. Right now we're really focused on this entry point with physicians where they can give this to patients in their office if they have symptoms of heart failure.

For those who've had heart failure before, they know because they can't breathe, they have severe dyspnea, they can't really sleep, they have to prop themselves up with a pillow. Here they can turn to Enbumyst. The second phase that we're looking at is really in hospitals and discharge protocols. That's to come later, but it's something that we're actively looking into from a strategic perspective. One last point I'll make is we closed the deal last week. We will have customer-facing folks in the field by May the 1st and will be fully launched by September with all of our representatives. Really excited, and the company's excited about the fact that we're playing in a large market with cholesterol and a large market in heart failure. This is a multi-billion-dollar market as well.

Serge Belanger
Senior Analyst, Needham & Company

Okay. You find this as an established market where you'll be looking to displace a certain standard of care with the nasal spray?

Sheldon Koenig
President and CEO, Esperion Therapeutics

No. Look, patients, what happens here, if you think about patient journey, most patients, if not all patients who are suffering from heart failure, are on oral loop diuretics, whether that be furosemide or bumetanide. In this inhaler, if you will, it's bumetanide, which is essentially 40 x more potent than furosemide. What happens is when patients have an episode of heart failure, they develop what's called gut edema. What happens is that they become resistant to the oral diuretics.

The goal is to get patients back on their oral loop diuretics as soon as possible, and then that's where we come in, and again, avoid the hospitalizations. There's a really true economic story here, and we're actually working on the budget impact model. We've already submitted a paper to the American Heart Failure Society of America, which has been accepted, which talks about some of those economics, and that will be presented, I think sometime, I might have the date wrong, but in the June timeframe, et cetera.

Serge Belanger
Senior Analyst, Needham & Company

Got it. In terms of other products on the market, was it just, like you mentioned, the oral products, or there's still an IV product that has gained some market share, I believe?

Sheldon Koenig
President and CEO, Esperion Therapeutics

I think you're leading me to scPharmaceuticals, which was purchased by MannKind, and that is a company that uses furosemide. Right now it's a wearable device. It's about as big as a hockey puck. You put that on your arm, and you have to wear it for five hours for five days. Pretty cumbersome. In all fairness, they're coming out with a auto-injector. That's their hope, but that's more for them. I think they realize they have something that's cumbersome for patients.

It's the same mechanism that's used to do once-a-month Repatha, and I remember with that, it would fall off a patient's arms, et cetera, and they'd be like, "Now what do I do?" Heart failure is a symptomatic disease, so you want relief as fast as possible. Again, that's the beauty about Enbumyst. All you need to do is take a puff in your nose up to maybe 2x a day for three days, and you're offloading fluid. Offloading fluid, just so we're all clear, is really about volume of urine that patients are able to go to the bathroom and offload the fluid.

Serge Belanger
Senior Analyst, Needham & Company

The product was approved in September 2025?

Sheldon Koenig
President and CEO, Esperion Therapeutics

Yes. Yep.

Serge Belanger
Senior Analyst, Needham & Company

Launched under Corstasis . Maybe now that the transaction is closed and you have a little more liberty to talk about the commercial efforts behind the product, maybe just talk about how many sales reps were behind it and what they were able to achieve.

Sheldon Koenig
President and CEO, Esperion Therapeutics

Yeah. Maybe I'll have Ben chime in on what Corstasis was able to do.

Ben Halladay
CFO, Esperion Therapeutics

The Corstasis team did a great job of preconditioning and laying out the foundation for a launch here, right? They had around 10 people out there discussing the product. They were at the major healthcare conferences for heart failure. They started putting together some of the case studies that really helped resonate well with physicians in terms of where and why they should use this product. Really, we see the true launch as once we have it in our hands and are able to do this phased-in approach where we'll have people out May 1st.

We'll have the full sales force out behind it in September. That's really what's going to drive the adoption of this. One other thing they did is they started having the initial clinical conversations with the payers. We're on the payer's radar. We're starting to pick up where they left off of those to get reimbursement for this product. They did a great job of essentially doing some of that pre-work that you need before the launch. Now we're taking up where they left off and really driving that adoption and awareness.

Serge Belanger
Senior Analyst, Needham & Company

Got it. Do you have a number on how many people they had out in the field trying to do that position?

Ben Halladay
CFO, Esperion Therapeutics

It was about 10 people, yeah.

Serge Belanger
Senior Analyst, Needham & Company

Okay. I assume Esperion is going to increase that number?

Ben Halladay
CFO, Esperion Therapeutics

We will have more than 10, yes.

Serge Belanger
Senior Analyst, Needham & Company

Okay.

Ben Halladay
CFO, Esperion Therapeutics

As a reminder, we have 155 sales reps right now. We will have all of them trained and marketing this come September, but we will also have some additional IDN-focused reps out there before then. We're going to have our fast star lightning launch, call it May 1st. We will have people talking about Enbumyst well ahead of September, but we will have the full power of our massive commercial infrastructure come September.

Serge Belanger
Senior Analyst, Needham & Company

Okay. In terms of access and reimbursement, this is a product that's mostly hospital-based, or there's still a significant outpatient component here?

Sheldon Koenig
President and CEO, Esperion Therapeutics

Well, in this case, it would be outpatient. What we have found is that most insurance companies that are paying for outpatient insurance are also paying for hospitalization. It gets back to that economic tie, where it could be very rewarding for all parties. I would just say for competitive reasons, we are in the thick of it, for lack of better words, as it relates to reimbursement and access. Give credit to Corstasis . Ben talks about that they had 10 people out in the field. I think the whole company was 10 people, and two people in the actual organization, the CEO and somebody else. They did a really good job in seeding the way, if you will, with access and reimbursement.

I've said this before, I'll say it again, I think we have probably one of the best, if not the best, access team in biotech. You've seen what we've been able to do with the bempedoic acid franchise, and this is all about knowing the right people, getting to them quickly, not only on the payer side, but also on the wholesaler side, et cetera, specialty distribution. We're looking at all those different areas.

Serge Belanger
Senior Analyst, Needham & Company

In terms of the breakdown between commercial and Medicare, what does it look like? Is it similar to bempedoic acid?

Sheldon Koenig
President and CEO, Esperion Therapeutics

I think just leans a little bit more heavier on the Medicare side of things. There's not many young patients who have heart failure, although we just came across one who is 35 years old in market research. The majority of patients are probably from that 50 years of age and older. I would say a little bit more heavier on the Medicare side.

Serge Belanger
Senior Analyst, Needham & Company

Okay. For people like us that are new to Enbumyst, is the FUROSCIX sales trajectory kind of a good proxy on what it could look like when the product is launched in your hands?

Ben Halladay
CFO, Esperion Therapeutics

Obviously we use FUROSCIX as kind of an analog for what this could look like. I will note a few different things. One, they've come out and said that they know where they went wrong, and they've been very vocal about where they went wrong with that launch, and we've definitely taken those learnings and factored them into our plan as well. We also think we have some pretty considerable product differentiation from them in terms of, like Sheldon mentioned, you strap a hockey puck onto your arm for five hours versus an inhaled agent is a lot more appealing to a patient. I think when we discuss it internally, that's kind of where we put the benchmark, but I do think we have some strong differentiation over them.

Serge Belanger
Senior Analyst, Needham & Company

Got it. As part of the acquisition, you also took over their pipeline, and I believe they also had an auto-injector product in development. Maybe just talk about the steps to bring that forward, and would it be a complementary asset to the nasal spray, or could play a broader role?

Sheldon Koenig
President and CEO, Esperion Therapeutics

Yeah, I think we have options there. We actually have a meeting with the FDA later this summer to talk about the pathway moving forward. We're looking at two different types of pen, one that could have a cartridge-based, one that could just be a fixed dose. You could actually do both. You could take what is in this guy, if you can see it on Zoom, and put it in a pen, or you can also maybe take a more potent dose and put it in a pen and use that in a clinic, because there are a lot of heart failure clinics as well, and give one dose of that. For us, it's more of a, I think, giving optionality. The beauty about it being nasally inhaled versus any type of pen is it's just easy.

I was just talking to a physician on last Tuesday, and he was telling me how patients just hate to use pens unless you tell them it's for weight loss. Otherwise, they don't want to use them. To me, it just reinforces the fact that the nasal inhalation, it's so easy. It's just the way to go. If people would prefer to use the auto-injector, we'll have one. The timing of that would be sometime probably in 2028.

Serge Belanger
Senior Analyst, Needham & Company

Got it. Okay. Maybe then if you just want to run us through the transaction details. I think there was $75 million upfront, but also some potential milestones and whether some of them are near term or not.

Ben Halladay
CFO, Esperion Therapeutics

Yeah. One of the things that we really liked about this deal is it essentially was one that I think we are all along for the ride, and the people who founded Corstasis are definitely, they believe in the future success of this drug and wanted to be a part of that. It was $75 million upfront. They have $180 million in sales-based milestones. As this drug launches, you'll hit certain thresholds that'll trigger some of these additional milestones associated with it. They also have a 15% royalty on worldwide net sales. A lot of their value's driven by the uptake of Enbumyst, and they definitely trusted us, and they trusted the uptake of the drug in our hands. I think we're all very excited for where this could take and go along.

Now, we financed that $75 million upfront through a combination of monetizing our Japanese royalties, which, as a reminder, they launched in November. Some of the initial success they saw made this a very attractive financing mechanism for Athyrium Capital, one of our partners. We also expanded the term loan facility by another $25 million. We really were able to take the success that bempedoic acid has shown and use that to be able to now kind of enter into an adjacent market here and diversify the revenue streams.

Serge Belanger
Senior Analyst, Needham & Company

Okay. How do you?

Sheldon Koenig
President and CEO, Esperion Therapeutics

I just want to add something to what Ben said, because I think this sometimes goes unnoticed or unsaid. Obviously we've had Athyrium partner with us before, when we did the converts, and we also had HealthCare Royalty. Also in this deal, it's Athyrium and HealthCare Royalty, but they were really big supporters of this. They did their own diligence, et cetera. They're really excited about this, so to have them on board and be sponsors of us again is just another feather in the cap of why this deal makes sense.

Serge Belanger
Senior Analyst, Needham & Company

Yeah. On the milestones, are they mostly all sales-based, or there's some regulatory that are more near-term?

Ben Halladay
CFO, Esperion Therapeutics

I would say none of them are within the next year or two. I think it's really going to depend on how quickly this ramp up is. Yeah, there's a regulatory one which is going to take a couple of years as is, right? It takes a while to go through that regulatory process with any new indication. I think they're a few years out, to say the least.

Serge Belanger
Senior Analyst, Needham & Company

Got it. Okay. Look forward to that relaunch on May 1st. Let's move on to NEXLETOL and NEXLIZET. I think a pretty significant development in the last, was it last month or the month before?

Sheldon Koenig
President and CEO, Esperion Therapeutics

Three weeks ago. We're talking about the guidelines.

Serge Belanger
Senior Analyst, Needham & Company

Last month.

Sheldon Koenig
President and CEO, Esperion Therapeutics

Yeah.

Serge Belanger
Senior Analyst, Needham & Company

Yeah, the update on treatment guidelines, just the importance of that, I know you had been waiting for a while for those guidelines to be updated.

Sheldon Koenig
President and CEO, Esperion Therapeutics

Yeah. Well, it's a real big deal just from the high-level perspective of having somebody else talking about where these drugs fit and why these drugs make sense, versus us always doing it. We've talked about that after the European guidelines came out on August 6th, and that's what Daiichi Sankyo heard from thought leaders. What we've been hearing from prescribers, what we've been hearing from societies, et cetera, is that, okay, I know where this drug can, should, and will be used, and that's really important. The fact that we received three Class A1 recommendations or 1A recommendations is a real big deal, and it's all in very serious patient types. We received four other recommendations as well. Now, in all transparency, they're complicated.

It's 142 pages, but we've been able to actually already go out in the field with a detail aid that representatives have that they can educate primary care physicians, for instance, on where to use the drug. Now when a doctor says, Geez, I have a patient who has documented ASCVD, and they have diabetes. I want to use it in that patient, but I'm not sure if that's a good spot. Well, Doctor, I can show you that we just received a Class 1A recommendation in that patient type. We're actually proactively showing different patient types and talking about where they fit in with the guideline. I think the most important aspect of the guidelines outside of the ratings that we received is that we are not, how can I say, we're not after another therapy, we're not before.

It's all equal choice, so we're not disadvantaged at all in the guidelines. The reason for that, and it's within the 142 pages, of which we're mentioned almost 90 times, because of the CLEAR Outcomes study. It really paints how successful the CLEAR Outcomes study was when it was presented in April of 2023, and when we received the label in April 2024. As a matter of fact, the guideline writers actually had a separate section on the CLEAR Outcomes study, so extremely important, really put some wind in our sails. We haven't reported first quarter yet. We will soon. Already, like for instance, in March, we saw a significant pickup in our business, which is important. You always have that January and February seasonality. March looks strong, will carry us with momentum going into second quarter, where we can further get the message out there as well.

One last thing I want to say about that is we also have medical science liaisons. We have six of them, and they're out there. They can actually go deeper in the guidelines with regional key opinion leaders, et cetera. They're out there doing that. Just to go back in time, they're also being very good in developing the market for Enbumyst as well right now. Again, it speaks to the infrastructure and what we can get out there in message.

Serge Belanger
Senior Analyst, Needham & Company

With these new guidelines and the return to target-oriented goals in treatment, do you expect that'll have an impact on the overall growth of statins and non-statin market? Go ahead.

Sheldon Koenig
President and CEO, Esperion Therapeutics

No. Well.

Serge Belanger
Senior Analyst, Needham & Company

Continue with that. Yeah.

Sheldon Koenig
President and CEO, Esperion Therapeutics

Yeah, no. Yes. Absolutely. I think people have died without targets. I think physicians would tell you that people have died without targets because it's easy for a physician to say, "Hey, use a statin, add ezetimibe, you're good to go," right? There's this whole fire and forget strategy. You can't do that anymore. You've got to get patients either to 75 or 55 mg per deciliter, and you can't do it with any one drug that's out there at all. That's what Europe focused on, and that's what the U.S. focused on. The days of just using one drug are over. Similar to diabetes and hypertension, you have to use multiple therapies. You have to do the same now with lipid lowering.

And again, that's the beauty of bempedoic acid, whether it's NEXLETOL or NEXLIZET, you can use it with anything, PCSK9, statin, ezetimibe is already in our drug, or you can use it on its own. And we play a big role. We've talked about in the past that 70% of the add-on market is ezetimibe, 12% is PCSK9, and there are places to use PCSK9, no question about it. But where that 72% of ezetimibe is being used, we want to be in that spot with NEXLIZET . That's what we're looking for.

Serge Belanger
Senior Analyst, Needham & Company

Okay. Do you think that the major impact is just an increase in awareness of bempedoic acid, or now it has kind of a more specific role within guidelines that'll be helpful?

Sheldon Koenig
President and CEO, Esperion Therapeutics

I think both. I think now you can reinforce the message that we are in guidelines and we should be used. Oh, by the way, doctors, you know, you've got to get these certain patient types of which we have different examples of patients to goal. There is a goal now, whereas before, for the past seven years, and actually a little bit longer, there hasn't been a goal. It's a really important step. Go ahead, Ben.

Ben Halladay
CFO, Esperion Therapeutics

I think one thing that was really revalidating and reinforcing is that where we were putting the guidelines is directly aligned with kind of where we've strategically been trying to market and position NEXLIZET , right? Primary prevention, statin intolerance. Those are the two key selling messages for this drug. The guidelines, we were front and center in those two categories. Statin intolerance, this is the first time it was a recognized category in the guidelines. When you look at what we're trying to do, it really is just a validation and driving force behind the strategic direction we'd already been taking these drugs.

Serge Belanger
Senior Analyst, Needham & Company

Yeah. Okay. In terms of expectations for 2026 for bempedoic acid, maybe just highlight the key drivers that you expect beyond the treatment guidelines.

Sheldon Koenig
President and CEO, Esperion Therapeutics

Well, I think for us now, again, the treatment guidelines was big. We presented two papers at the last American College of Cardiology. We will continue to put out publications, et cetera, as it relates to bempedoic acid and where it should be used. 2026 is really a year of execution. It's really getting out there now with all the tools that we have in the bag, the big one that we've been waiting for, guidelines. Two years ago, we waited for the label. Now we waited for guidelines. Now we have what we need to get out there and really send a powerful message to physicians and continue to gain awareness. The other thing I will say is our digital program is humming along. We feel really good about how we are commercializing these drugs via digital.

We haven't gotten the recent return on investment, but when we last looked at it at the end of the year, we were getting almost a 7/1 return with digital interface with physicians. This is where physicians were not even seeing a representative, and we were seeing that physicians were writing the drug. Again, we've always felt that we have that right balance between personal and non-personal promotion, and we're going to continue that.

Serge Belanger
Senior Analyst, Needham & Company

Okay. I know we're going to get 1Q results in the next month, but just curious if the typical 1Q softness was worse than usual this year, just given some of the winter storms. That's something we've been hearing. I don't know if you've experienced the same.

Sheldon Koenig
President and CEO, Esperion Therapeutics

Yeah. We did. We were in the same country that had the snowstorms, et cetera. I think it's the same seasonality that we saw last year. Definitely was hampered more by there was over two weeks where people couldn't even get out. I know where I am, for over two weeks, schools were canceled because there was snow and ice. It was all through the Mid-Atlantic. I think it also affected distribution, and we saw the same thing last year where you had softness in January and February, then business really started to pick up in March, and we're seeing the same thing.

I think the other thing is just insurance adjudication. I don't think people realize that patients change insurance companies almost every two years, in some cases. Not everyone, but a lot of them. You have new prior authorizations, new adjudications, et cetera. That always happens in the January, February timeframe as well. It's the same seasonality I think we see every first quarter. I'll let Ben, if he has any additional comments on that.

Ben Halladay
CFO, Esperion Therapeutics

No, I agree with everything Sheldon said. I do think the winter storms were egregiously bad this year and, to Sheldon's point, affected not only just the patients going out and getting the drug, but also getting the drug around the country. The distribution side of it was certainly affected as well. We are, I think, recovering from that. I do think some of that's going to spill into second quarter as things catch up. Another reason why, despite the usual Q1 seasonality, we're really excited for the full- year.

Serge Belanger
Senior Analyst, Needham & Company

Okay.

Sheldon Koenig
President and CEO, Esperion Therapeutics

I think we actually had a drug launch during that time, too. I get confused if it was January.

Ben Halladay
CFO, Esperion Therapeutics

They did. No, that was it. Yeah, they tried getting the drug out, and it crashed.

Sheldon Koenig
President and CEO, Esperion Therapeutics

Yeah. I was worried about the driver. Ben was worried about the product. No, I'm just kidding. It's all good.

Serge Belanger
Senior Analyst, Needham & Company

In terms of ex-U.S. commercialization of bempedoic acid, I feel that's seen a lot of progress, a lot of growth. Maybe what should we expect in this year? I know Japan's coming online a little with the launch in November. I feel that's a revenue line that's becoming increasingly important for you guys. Maybe just give us a little color on how that could look like for 2026.

Ben Halladay
CFO, Esperion Therapeutics

Yeah. I'll start with Japan. I just want to first, with Japan, caution that statutorily, don't expect much from Japan. They are capped on what they can prescribe in the first year, but they kind of control that via requiring renewals every 14 days. The adherence is not there, but they're taking a great strategy, and instead of focusing on the volume of prescriptions, they're focusing on the volume of prescribers so that once that cap is lifted, you have massive awareness and sort of the attrition factor goes away. I think after that 12-month stay on renewals, they're off to the races, right? I would expect a very similar trajectory for them as I would for Daiichi Sankyo Europe.

Speaking of Daiichi Sankyo Europe, they launched France in this first quarter, which is a country that not only isn't a given for reimbursement or launch, but they managed to receive very favorable reimbursement. That's a massive market that is just incrementally on top of everything else they're already doing, and they've already done a great job of continuing to grow the existing prescribing in existing countries. Now you add on a massive market like France, and I think we can just continue to expect the same growth they've always shown.

Serge Belanger
Senior Analyst, Needham & Company

Got it. The Company has completed many settlement agreements with generic filers over the last 12 months-16 months. How many are left? Do you expect they'll have the same terms?

Sheldon Koenig
President and CEO, Esperion Therapeutics

Ben, you want to?

Ben Halladay
CFO, Esperion Therapeutics

Yeah. We have a handful left. There are four left. Three are acting as a consortium. Look, we are optimistic that we will continue to have positive resolution with these remaining litigants, and I think there is plenty of trajectory left on bempedoic acid. We started planning this franchise well into the 2030s. We'll be well past 2031, is where we are thinking about this internally.

Sheldon Koenig
President and CEO, Esperion Therapeutics

Yeah. I would just add, we've always said we believe in the strength of our patents, and we do have the presumption of them being valid. I think that's why you've seen these others that have already settled, and again, it just speaks to our confidence in the strength of the IP. We've always said that even before we had the five settlements previously.

Serge Belanger
Senior Analyst, Needham & Company

Yeah. In terms of competition, there's expectations of new LDL lowering products coming onto the market maybe as early as this year with Merck's oral PCSK9. Maybe just how do you view the competitive landscape and the potential impact on bempedoic acid in the coming years?

Sheldon Koenig
President and CEO, Esperion Therapeutics

Yeah. Look, first of all, I think there's room for all competitors. Products are going to come to the market. We can't stop them from coming to the market. I think the Merck PCSK9, we saw the data that they presented. The NEXLETOL data actually was similar to what we've shown in our studies. The data versus NEXLETOL made absolutely no sense, and they couldn't explain it. We studied that drug in over 24,000 patients and have consistently shown that the LDL lowering is 22%. Really, to me, I question just the protocol. They have a fasting issue. I know they're trying to address that. They're trying to minimize that. When they come out, their strategy is going to go after injectable PCSK9, is my guess, having worked at Merck for many years.

As relates for us, we have an outcome study, and we're indicated in both primary and secondary prevention. For us, it's sticking to our story. We're also in the guidelines. They won't be in the guidelines. They won't have outcomes until the end of 2029 or 2030. They'll be out on the market, but we just need to stick to our story and our execution. I'll end it with, there's a reason why cardiovascular disease is the leading killer in the United States and the entire world, because physicians are not doing enough to maximize the drugs that are currently available now and/or in the future to get patients to goal. Plenty of room out there, but again, the fact that we have outcomes data is extremely important.

Serge Belanger
Senior Analyst, Needham & Company

We only have a few minutes left, so let's touch upon the pipeline. You are developing a triple combo product. Can you highlight the timelines and what's left in terms of development steps for this program?

Sheldon Koenig
President and CEO, Esperion Therapeutics

Yeah. Well, now it's all about just stability data. We've always stated for a 505(b)(2) strategy, you need bioequivalence. We have that. Just as a reminder, this is a drug that is used with not only atorvastatin or rosuvastatin, so a physician will have a choice. Remember what I said earlier, no longer can you get to goal with one drug. This drug has the ability to maybe get you to goal. It definitely has potential of being the most efficacious LDL-lowering drug on the market with LDL upwards of 70%. We hope to be on the market in 2027.

Serge Belanger
Senior Analyst, Needham & Company

Okay. Your European partner, Daiichi Sankyo, are they launching this product in Europe? Have they given any timelines? On when that can happen?

Ben Halladay
CFO, Esperion Therapeutics

They've not come out with their timelines. I will say likely similar to ours, but they're very excited to launch this in Europe. There's a significant opportunity over there for the triple combination.

Serge Belanger
Senior Analyst, Needham & Company

Okay.

Sheldon Koenig
President and CEO, Esperion Therapeutics

To your point, this has been jointly developed. We're having a little celebration with them in June, so it's a real exciting time. I've said this many times, I'll say it again, bempedoic acid is a global brand. Now Esperion, we're more of a global company than we ever were before, especially with Enbumyst. We forgot to mention, we always talk about the United States. We have the rights for this drug in Asia and Europe, and we're thinking about how we'll plan to move it forward in those areas as well.

Serge Belanger
Senior Analyst, Needham & Company

Okay. The PSC program still on track to enter the clinic this year with the IND filing?

Sheldon Koenig
President and CEO, Esperion Therapeutics

Yes is the simple answer.

It is on track and, again, it stays within that cardiometabolic world that we've talked about. In this case, now we're getting more into a rare orphan area. It's definitely an unmet need. We've had patients already writing to us, asking us how they can help, et cetera, so we're trying to move as quickly as possible.

Serge Belanger
Senior Analyst, Needham & Company

I think.

Sheldon Koenig
President and CEO, Esperion Therapeutics

That drug treats the disease, Serge. That's what's important. This isn't a drug that treats symptoms. This is a drug that goes to the injury in the liver and treats it, and there's nothing like that right now.

Serge Belanger
Senior Analyst, Needham & Company

Just to wrap up here, Ben talked a little bit about financials earlier, gave us an overview. In terms of the manufacturing tech transfer. Where is that, and when do you expect to start seeing some of the cost savings associated with that?

Ben Halladay
CFO, Esperion Therapeutics

We are on track, I would say. I think we've said we will see a phase into their manufacturing over the course of the year, and by the end of the year, our gross margins will be much more in line with where I would expect a small molecule biotech to be. I think they've started manufacturing one of them, the monotherapy, this year, and they'll start the combination therapy very shortly. By the end of the year, we will be in a much better position from a gross margin standpoint.

Serge Belanger
Senior Analyst, Needham & Company

Okay. Sheldon, I'll hand it off to you to wrap up here. Anything you feel investors or us analysts are missing or misunderstanding about Enbumyst or bempedoic acid or the pipeline?

Sheldon Koenig
President and CEO, Esperion Therapeutics

No, I think you covered all the points, and we really appreciate it. I think the most important thing is that, again, things that we've said that we are going to do, we've done them. Corstasis being the one that I don't think was on anyone's radar, and it's a deal that expands this company, expands the opportunity for us to even be bigger years down the line as we paint out our 2040 Vision. Stay tuned because we're excited as an organization, and we're going to continue to keep showing the growth that we've been showing and be a successful organization. Again, we really appreciate the time.

Serge Belanger
Senior Analyst, Needham & Company

All right. Well, gentlemen, thanks for your time. We appreciate your participation.

Sheldon Koenig
President and CEO, Esperion Therapeutics

Awesome. Have a great rest of the week.

Ben Halladay
CFO, Esperion Therapeutics

Thank you very much.

Sheldon Koenig
President and CEO, Esperion Therapeutics

Take care.

Powered by