Esperion Therapeutics CEO Sheldon Koenig

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The BioWorld Insider podcast

 

Lynn Yoffee

This is the BioWorld Insider podcast. I’m Lynn Yoffee, BioWorld‘s publisher.

 

Today’s podcast is sponsored by Esperion Therapeutics.

 

Esperion Therapeutics is a commercial-stage biopharmaceutical company focused on bringing new medicines to market that address unmet needs for patients. The company developed and is commercializing the only FDA approved oral, once daily non-statin medicines for primary and secondary prevention of cardiovascular disease in patients who are struggling with elevated LDL cholesterol.

Esperion Therapeutics continues to strengthen its presence in the industry through commercial execution, international partnerships and advancements of its preclinical pipeline.

 

We have the CEO Sheldon Koenig with us on the podcast today. Hello, Sheldon.

 

Sheldon Koenig

Good morning.

 

Lynn Yoffee

He’s here today to chat with Lee Landenberger, a BioWorld staff writer and the BioWorld Insider podcast host. Lee, over to you.

 

Lee Landenberger

Thanks, Lynn. And Sheldon, I’m really pleased to have you with us today.

 

Sheldon Koenig

Thank you for having me. I really appreciate it.

 

Lee Landenberger

Our pleasure. So tell us about Esperion. What’s the company’s current focus and where do you plan to go in the future?

 

Sheldon Koenig

Yeah, great. Thanks, Lee. And again, it’s really great opportunity for us to be here on the podcast with BioWorld and have the opportunity to talk about Esperion Therapeutics. And when I talk about this company, I speak about it as all the 305 employees that are here. So we all thank you for this opportunity.

 

Our current focus at Esperion currently is our bempedoic acid franchise that consists of two products, Nexlizet, which is bempedoic acid, plus ezetimibe, a drug formerly known as Zetia, so it’s combination therapy. And then Nexletol, which is bempedoic acid on itself. That is our No. 1 focus. And as was mentioned, I believe in the introduction of the podcast.

 

These are important products in the regimen and paradigm, if you will, that doctors use to decide how to treat patients and get them to lower their LDL cholesterol or their bad cholesterol.

 

Now the other thing about Esperion is that what you’ll find is usually with small, mid-cap companies like ourselves, you’re either commercializing a product or you have a product in the clinic and you’re bringing that product forward.

 

I think something that we all take pride in at Esperion is the fact that we’re not only commercializing products, but we have a very interesting pipeline. As a matter of fact, we have in the past issued a press release that talked about bringing forward a candidate for primary sclerosing cholangitis. This is a very serious liver disease and we’re very proud that we can bring a candidate like this because it also brings promise of hope for these patients that have this type of disease.

 

We also have a very interesting pipeline related to kidney diseases. And this ranges anywhere from polycystic kidney disease to chronic kidney disease. More to come on that later in the next year or so. But that’s another element that just truly differentiates us. And I think just one other aspect is outside of products.

 

You know, we talk about the fact that we market products in, obviously, the United States, but we have partners in Europe. We have Daiichi Sankyo, which is a very large company that markets this drug in Europe and some parts of Asia and South America. And we have a very significant partnership also with Otsuka, who will be at some point launching the drug in Japan.

 

So I think sometimes people think about Esperion as an organization that’s just really vested here in the United States. That’s true. But it’s really this partnership with these other companies that gives us this global presence and essentially a global mindset as well. We also just signed two deals where we’re working with CSL Seqirus in Australia, we’re working with HLS in Canada again to get this product out to those patients who need it across the world.

 

Lee Landenberger

So, the last couple of years have seen some significant milestones for Esperion. So tell me about the important successes that you and the company have realized since 2023.

 

Sheldon Koenig

Yeah, thank you for asking that. And I’m glad you said since 2023 because we could spend probably the entire podcast if we went back to all the way to 2021. So I’m going to start with the Clear Outcomes study. So the Clear Outcomes study was actually presented at ACC in 2023 and that was presented by Steve Nissen on that day.

 

I always say to folks, investors, we were kind of like a band that nobody knew. And then we went to overnight success. That was a real game changer. We received over 1 billion impressions globally. We were on the national news, we were everywhere, anywhere on the internet. They talked about the Clear Outcomes study, which again was a 14,000 patient outcome study.

 

It was also a study, one of the first studies to have over 50% of the participants be women. So just from that perspective, it was very interesting. And as was mentioned in the introduction, we not only studied secondary prevention, but we studied primary prevention in the same study. And there’s something noteworthy about that if you fast forward to end of March, April 2024, we received our Clear Outcomes study.

 

And that study was a game changer for us as far as a label. So we received the label as it related to the study that was presented in 2023. That allowed our representatives now to actually go out and talk to physicians, both primary care and cardiologists about the significance of the Clear Outcomes study.

 

And although we won’t go into the details today, folks have the label available and go on the website. But physicians immediately picked up on the value of not only what we demonstrated from a secondary prevention perspective, but also primary prevention. I mean think about it. Primary prevention is essentially preventing an event before it happens.

 

Very important. And again, we’re truly the only oral non-statin to have that type of indication. So it’s very much a differentiation for us. So we have this expanded label. Obviously, our partnerships I mentioned earlier with Daiichi Sankyo Europe, it allowed them to also apply to achieve a new label, which they have.

 

It also allowed them to further expand in more countries. And so again, something that was very important for, for them as well. And we actually worked together as teams through this time from 2023 on of what is the best strategy to market these drugs? What is the best way to get surround sound around these organizations?

 

I mentioned the pipeline earlier. The pipeline prior to 2023 was somewhat forgotten. It was just really kind of sitting there and we said to ourselves, well, how can we actually do a better job of dedicating more time to research and development? And we did that. I think also importantly is we are a very well capitalized organization.

 

So this was an organization that originally was faced with a very poor capital structure. And talk about just a complete turnaround. We’re an organization now that has the capital structure that we need and makes us financially sound from now into well into the future. As a matter of fact, we’ve actually stated that by 2026 we will achieve sustaining profitability.

 

That’s important with a company that two years ago had close to $1 billion in debt and we were able to erase the majority of that. So it’s not often you see those type of turnarounds, but it’s allowed us to do what we’ve done to be demonstrating growth, expanding our field, salesforce, etc.

 

Lee Landenberger

I want to ask you a little bit more about the science and you mentioned statin intolerance. Would you talk to me about what that is, what it means for patients and their physicians and how Esperion is addressing the situation in a different way.

 

Sheldon Koenig

Yeah, that’s great. And I’m also going to tie into that answer some recent guideline approvals as well. So you’ll hear it from my perspective and then I’m going to talk about it and how Europe is thinking about it and how hopefully as we go into future U.S. guidelines, we’ll think about. So statin intolerance is, is really, it’s, it’s real, it’s.

 

Some patients just cannot take a statin at all. They have muscle pain. I always point to my arm because I get it too sometimes. They have myalgia, they have leg pain, etc. Um, other patients can take a statin, but they can only take a low dose of a statin. And you might be thinking, well, my doctors talk to me about statins, aren’t there, you know, they, they can’t go to the higher doses.

 

If you can’t take a low dose statin, you probably can’t take a higher dose statin. And even if you can, you’re only getting 6% more LDL reduction. So statin intolerance is not just the people that can’t take a statin at all, just can’t take it. And there’s a lot of those, but it’s also those who can only take a low dose statin and they’re still not at their LDL goal.

 

And so there’s this gap. And I think what’s important also is we’ve actually have done our own proprietary market research and we’ve shown that up to 20% of patients who have been prescribed a statin, and these are millions and millions of patients, they don’t take anything, leaving them at risk of having a cardiovascular event.

 

And you know, let me just remind you, Lee and everyone else, I’m not a physician, I’m a business person. But you having faced high cholesterol myself, been in the lipid market since 2003. You learn from key opinion leaders, etc. You know, a heart attack or a stroke, you know, any type of cardiovascular event that can happen out of nowhere.

 

I think people think of this as a very low, slow progressing disease, but you never know when plaque is going to break off. And treating aggressively is important, just like we treat diabetes and hypertension. Importantly, and what I’m leading to is, if you think about diabetes and hypertension, that treatment is usually addressed with multiple therapies.

 

And at this year’s European Society of Cardiology in Madrid, and I was there, the opening presentation were new lipid guidelines. And what they started with is one product alone will not get you to goal, it just won’t. And then they segued into what were the changes of the guidelines. And one of the biggest changes was around bempedoic acid.

 

And bempedoic acid was essentially presented as almost a foundational therapy to all other lipid lowering agents to help patients get to goal. And the reason for that, and they mentioned this specifically and I invite anyone to go and that’s all online through the European Society of Cardiology website. They said the reason for these changes to bempedoic acid were based on compelling and practice changing data from the Clear Outcomes study.

 

So just to circle back to what we talked to earlier really showed the importance of, of really this bellwether event with the successful Clear Outcomes study and getting the label specifically at the guidelines. What they talked about were also statin-intolerant patients, those patients again who can’t take a statin at all and those patients who can only take a low-dose statin.

 

Those are millions of patients. You know, just to think about our just overall therapeutic market, it’s 70 million patients that are not getting the adequate treatment, are not getting to LDL. This is one of the largest therapeutic markets in the world. So as another reinforcement, I was very proud to be sitting in the audience.

 

You know, we all, like I said, we’re a global company, we work on bempedoic acid. We know U.S. guidelines will be coming out soon, sometime in the first quarter of 2026. Our hope is that bempedoic acid will have that same type of presence. And we’re looking forward to see what those guidelines look like.

 

Lee Landenberger

With this kind of success, why would Esperion expand into entirely different disease states? Like, so, we’re talking about liver disease and PSC. What was the attraction?

 

Sheldon Koenig

Well, we view ourselves as a cardiometabolic company. So we’re not only addressing lipids, which we’re doing today, but just based upon our pipeline, based upon what’s called ACLY biology, which is essentially a scientific platform we feel, and if we even look at liver, we have met this intersection of fibrosis and cell metabolism.

 

Now our head of research and development, Steve Pinkosky, could educate you much more than I could. I only know the surface of this. But we have the opportunity, especially with primary sclerosing cholangitis, to not only treat the disease, but reverse the disease, possibly cure the disease, stop a patient from having to get a liver transplant.

 

I would invite everyone, I’ll take this opportunity that on our website. We held a research and development day on April 24th. It’s on our website. We conducted it in New York City at the NASDAQ building. We had two well-known thought leaders and we also had somebody who represented the community of PSC.

 

And when you watch a patient talk about the fact that they’ve been through two liver transplantations, when you see the head of this association talk about her 17-year-old son who’s been diagnosed with PSC, how could we not develop and bring something forward in this high unmet need? And you know, anybody that was there, anybody has watched that and anytime I’ve seen patients talk about a disease they’ve had, a serious disease that they’ve overcome, it’s really compelling.

 

You know, that’s why we’re in this business, that’s why we do what we do. And there’s a lot of need out there. You know, a lot of people don’t want to hear unmet need, but there are a lot of unmet needs. We all know people who have different type of diseases or illnesses that they could benefit from other drugs.

 

And we have the research and development capacity to do it. I’m super excited about it. I’m super excited about how it makes the company bigger as well. And I think that’s also an important point.

 

Lee Landenberger

So what are the next steps in addressing the disease state?

 

Sheldon Koenig

So the next steps are. So right now we’re in the early stages. Obviously when you’re developing a drug, you want to get to a point where you are IND enabled and then you get to the clinic. We probably will by the end of next year be approaching our IND and then soon after that in the clinic.

 

And that’s when things really get real. So they’re real now, but then they really get real and that’s exciting. I love new drug development. I’ve been in this industry for 35-plus years. I think I’ve launched at least seven products. I brought several products from development to launch. I have founded a company outside of Esperion that is developing a drug and it’s just exciting because it meets an unmet need.

 

And but for PSC, the next steps are really again, you know, getting to IND and getting into the clinic and then also focusing on our kidney program.

 

Lee Landenberger

Yeah, I’m curious about what drives you, what drives you personally and professionally and how does that translate into the vision for the company?

 

Sheldon Koenig

Yeah, I think what drives me is, you know, I’ve always loved the pharmaceutical industry. You know, my dad was a pharmacist so I’ve heard about drugs, you know, all my life. I, you know, I talked about patients. I’m a cancer survivor. I was saved by what’s called the CHOP protocol, which is like four of the most toxic chemotherapeutics you could ever receive, given three and a half months to live.

 

And you know, here I am 16 years later, you know, knock on wood. I was always driven before, but I’m driven even more. You know, you don’t take any day for granted. And I also, you know, I realize in my position I have the responsibility of 305 employees and also are all of our investors.

 

And you know, we have two goals, right? We want to make sure that the company continues to grow, it’s profitable, actually. Three goals. It’s a stable organization for our employees. And the third one is bringing lifesaving medications. And obviously you can’t bring lifesaving medications to the populations unless you have all the other things working.

 

And I think all of us, all of us at Esperion, we believe that, we believe that we are delivering medications and working on medications that are helping patients. We have the outcome studies to show it for Nexlizet and Nexletol and hopefully in the future we’ll have the studies to show it for PSC and other drugs that we bring forward.

 

And that brings a great deal of pride, I think, to not only myself, but all the other employees that work here.

 

Lee Landenberger

Terrific. Well, thank you so much. I appreciate your time and your insight and the best of luck to you.

 

Sheldon Koenig

Well, thank you. I want to thank Lynn and I want to thank you, Lee, and again. Have a great rest of the year.

 

Lee Landenberger

Thank you, Lynn?

 

Lynn Yoffee

That’s our show for today, sponsored by Esperion Therapeutics.

 

As always, BioWorld will continue to keep you informed of all the most important scientific, clinical, regulatory and business updates. We’re a daily news service covering the development of the most innovative human therapeutics designed to improve the human condition. If you need to track the development of drugs, turn to bioworld.com. You can follow us on LinkedIn or X.

 

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