Esperion at The Citizens JMP Life Sciences Conference: Strategic Growth Insights

On Thursday, 08 May 2025, Esperion Therapeutics Inc. (NASDAQ:ESPR) presented at The Citizens JMP Life Sciences Conference 2025, highlighting its strategic initiatives and financial outlook. The company emphasized the promising results of its cardiovascular drug, bempedoic acid, while addressing recent challenges and outlining future growth opportunities. Esperion is optimistic about overcoming a first-quarter slowdown and achieving double-digit growth.

Key Takeaways

• Esperion’s cardiovascular drug, bempedoic acid, showed significant benefits in reducing cardiovascular events, expanding its market potential.
• The company resolved confusion related to Medicare changes, which had affected first-quarter performance.
• Esperion aims for double-digit growth, driven by label extensions and geographic expansion.
• Financial improvements include reduced debt and refinanced convertible notes.
• The company is pursuing new business development opportunities in cardiometabolic areas.

Financial Results

• Debt Reduction: Esperion reduced its debt from approximately $700 million at the start of the year.
• Convertible Notes: 80% of $265 million in convertible notes were refinanced, extending the due date to 2030.
• Q1 Cash: The company ended the first quarter with $114 million in cash.
• Japanese Regulatory Process: Esperion anticipates milestones in the second half of the year related to Japanese regulatory approval.
• Canada Partnership: A $50 million milestone is expected from the partnership with HLS Therapeutics in Canada.
• Growth Metrics: Esperion forecasts consistent growth of 10-15%.

Operational Updates

• Label Update: A label update in April expanded the patient population for bempedoic acid.
• Reimbursement Access: The drug now has reimbursement for primary and secondary prevention settings, reaching 70 million patients in the US.
• Prior Authorization: Simplified or removed prior authorizations with major payers.
• Sales Force: The sales force was enhanced ahead of the label update.
• Marketing: Targeted digital marketing campaigns and consumer plans have been implemented to increase awareness.

Future Outlook

• Growth Trajectory: Esperion expects to return to a double-digit growth trajectory.
• Generics Litigation: The company anticipates resolving generics litigation by 2027, with confidence in patent protection.
• Triple Combination Therapy: Development of a therapy combining bempedoic acid, ezetimibe, and a statin is underway.
• Pediatric Trial: A Phase 3 trial for familial hypercholesterolemia is in progress, potentially extending patents by six months.
• PSC Development: ESP one three three six is being developed for primary sclerosing cholangitis, targeting a billion-dollar market.

Q&A Highlights

• Medicare Impact: The first-quarter slowdown was due to Medicare changes, now resolved.
• Physician Feedback: Physicians have responded positively to the drug with minimal pushback.
• Market Share: Primary prevention settings are the main drivers of the drug’s utilization.
• Commercial Spend: Current spending and sales force size are deemed adequate, though resource reallocation is possible.
• Loss of Exclusivity: Solid intellectual property protection until mid-2031, with potential extensions to 2040.

For a deeper dive into Esperion’s strategic plans and financial performance, refer to the full transcript provided below.

Full transcript - The Citizens JMP Life Sciences Conference 2025:

Unidentified speaker: I guess take a step back and Primary. I guess take a step back and go go through the data that went into those new labels. Can you just walk us through the clear outcome study and the findings there?

Unidentified speaker: So the clear outcome study was a 14,000 patient outcome study which measured MACE four, MACE three in a variety of endpoints in both a, in a non statin population in both a primary and secondary prevention patient population. So, why that’s important is that’s obviously the ticket to the game for cardiovascular event. The results were fantastic. You know, we showed some very meaningful reduction across all those endpoints. But really compellingly is we saw, you know, almost forty percent reduction in in events in a primary set primary prevention setting, you know, those are patients who have not yet had a cardiovascular event.

And, you know, a patient population that previously only had statins as an option, which as we know, with statins there are a lot of nasty side effects. We believe up to thirty percent of the population can’t take enough of a statin to meet their goals, to meet their cardiovascular health that they need to. And being able for us to demonstrate a benefit in that population gives a whole new slate of tools for primary care physicians, for patients who want to help manage their LDL C and their cardiovascular risk, in an area that there previously was nothing except for statins.

Unidentified speaker: Right, right. So maybe walk us through the first couple years of the launch, and what changed when you had the label updates, both in terms of what changed in terms of your focus, messaging, but also the organizational investment.

Unidentified speaker: Yeah. So when we first launched, it was March of twenty twenty, which of that month sounds familiar to anyone. That was the month that everything shut down and I remember scrambling going to the grocery store thinking, don’t know when I’m gonna be able do this next. So it was a it was a difficult time to launch. We launched with, I would say, a fairly

We were indicated for ASCVD patients on top of a max tolerated dose of statin, which in The US is really only about eight million patients. It also was a difficult drug to get reimbursed just because of that hyper restrictive label. So in October 2021, we right sized the organization. We had, I think, 300 representatives at that point. We went down to 70, and we made two promises.

Unidentified speaker: Mhmm.

Unidentified speaker: We promised that we would continue to grow consistently every quarter, which we have done since then. And we promised we’d focus and get to a positive readout of the clear outcomes trial, which I just mentioned. We did. Yeah. And so back in January of last year, we sort of re upped our sales force again knowing that the label was coming in April.

We’ve sort of built the infrastructure needed. We have a I I don’t know if I’m supposed to use this phrase. We have a legitimate enterprise, a commercial organization. And, you know, we’ve been using that as a fuel since, since label. We had them out a few months beforehand to kind of get primed and get ready for, know their routings, their positions so that when we did get the label, and then when we further got later reimbursement access around the new label, you know, they were already familiar and and familiar with the territories.

And so after April, we got the new label, and I would also point out in, I would say, unheard of timeline, the payers came around to this new label. So we received reimbursement for not only the outcomes benefit in both the primary and secondary setting. We were able to be used with with or without a statin, which I think opens up seventy million patients for us in The United States. And not only that, but I’ve just been blown away at the ease of the access. So the in many of the major payers, the prior authorizations are gone, which I I have never worked on a branded drug that did not have a prior authorization.

And even those that do have a prior authorization, it’s minimal. Some a lot of times it’s an electronic look back or it’s just an attestation of checking a box and submitting the form. And, you know, that to me was the real sort of watershed moment of how do we grow this drug because what was before our biggest hindrance in getting this drug in patients’ hand was all all but gone. And that’s been the case consistently. We’ve brought new payers online.

I think we’re up to about 190,000,000 covered lives in The US under the new label, the new prior authorization criteria.

Unidentified speaker: So I think you kind of pointed at this, prior to the label update, what was stopping physicians using the drug? To what extent was it reimbursement access versus wanting to see more data?

Unidentified speaker: It was, it was completely an access problem. Physicians love the data. I will say that forthright. It’s a tool that they, they haven’t had before. The outcomes data is incredibly compelling, especially in that primary prevention population that I mentioned.

And it’s an exceedingly tolerable drug. We’ve not heard any issues from tolerability or from side effects or the patients discontinue because they don’t feel like they can take it. It was strictly an access problem. And so it was difficult to get through that reimbursement process. We could not go into the primary care setting for that exact reason.

And so now, you know, there’s still a slight perception that it’s difficult to get and we’re actively working manage that. So we have 15 reimbursement managers out in the field now who are helping doctors offices walk through that reimbursement process and saying, you hear the plans that you have, you don’t have a prior authorization, here’s the ones that you do. And when you do have the prior authorization, we will help you navigate that. So we’re actively working to mitigate that perception out there and I think we’re

Unidentified speaker: seeing some really good progress there. So what are the, what’s the feedback from physicians now that you’re hearing, you know, in terms of, they have access to the drug, they’re trying it in more patients and different patients. How how’s their perception of benefit and safety? So

Unidentified speaker: the ones that we’re that we’re talking to, they they they love it. We don’t get any pushback to be perfectly honest. We occasionally hear some murmurings around the access side, but we think that’s just residual from before. You know, our our biggest time now is just more awareness. And so getting out there and getting in front of more doctors and and and getting the name out there.

And and I think we also have some targeted digital consumer plans that we’re doing in the second half of this year as well that will help spread that awareness. You know, it’s progressing and we do we test our unaided awareness every twice a year

Unidentified speaker: Mhmm.

Unidentified speaker: And we continue to see progress against that. So we’re making good progress. And I would say right now we’re about where I would expect for a drug of of this life cycle. We just need to continue that momentum on on awareness.

Unidentified speaker: So then digging in more on that that marketing effort, what tools are you using in terms of digital media versus DTC advertising or, you know, where do you think the the right investment is?

Unidentified speaker: So I’m I’m actually always pleasantly surprised, I’ll say, by the return that we get on our digital resources. So it’s very targeted to the physicians that we know are likely to be prescribing our drug. These are ones that prescribe a lot of Ezetimibe. They’re ones that, are, you know, they’re not necessarily the entrenched statin or PCSK9 doctors. And we can target them directly in terms of an awareness campaign through the digital avenues that physicians use.

On the patient side, we’ve been able to lipid lurkers. They’re little minion looking things that, you know, lurk inside your arteries and kind of awareness on what that could mean. And I think if you go to like the Cleveland Clinic website for statin intolerance, they’re hanging all over the place. So looking at ways that patients who are concerned about their statins, or the side effects of statins, which there are a lot of patients out there. I had one physician mention, you know, the the TikTok doctors are his biggest nightmare because they talk about the dangers of statins.

And there are a lot of people out there, getting them kind of that next step of there is an option available for you and we’re able to target them very directly and very succinctly.

Unidentified speaker: Where do you think you’ve moved in terms of know, a high level market share in terms of those those populations like primary prevention or, statin intolerance, the secondary prevention. Where are you being used most?

Unidentified speaker: So I think we’re being used mostly in the primary prevention setting You know, we’ve seen really good progress there, and we’ve seen a good response there. And honestly, that’s where our value driver is. Right? We’re the only ones playing in it right now, and for the foreseeable future.

And of that seventy million patients, that’s I think forty million of them. So there is a sizable market there that we can go after, that we have demonstrated outcomes in, we

Unidentified speaker: have a demonstrated benefit in, and that we know physicians need an answer for. Got it. So we’ve seen this uptake show up through the prescription data. You saw a really good double digit growth quarter over quarter throughout last year. First quarter slowed down a little bit.

Can you just walk us through the dynamics there?

Unidentified speaker: Yeah, it was an interesting first quarter with some of the changes that happened on the Medicare side, right? This is the first quarter that we saw the IRA in place and some of the new cost sharing and smoothing out of how all that works. And from patients, from payers, and from providers, we heard a lot of confusion.

Unidentified speaker: Okay.

Unidentified speaker: What is my deductible? What is my copay? What do I have to do to get, you know, this prescription pushed through? And even some questions around is Medicare even going to be funded period?

Unidentified speaker: So

Unidentified speaker: there, if you, if we split out internally and look at growth in the commercial plans and growth in the Medicare plans, and when you split those out, commercial plans were growing exactly the way we expected them to, the hampering was entirely on the Medicare side. So we heard some deductibles back in January, or not deductibles, co pays back in January, some upwards of 200 for patients. And so patients would be deciding, do I take my asymptomatic LDL C drug or do I take my diabetes medicine? Right. So that obviously was a headwind for us.

The good news is, and I was just in an investor meeting talking about this, they said, how can you be confident that, you know, I’ll this next question. Right. Yeah. Of of of a return to normalcy. And the answer is we’ve already seen it.

Yep. So we’re already back in the prescription growth trajectory that we would expect to show that double digit growth. We’re, you know, we’re on pace to do very well. And, you know, the copay reset now, I think we’re seeing copays of $20.30, $40, and in a lot of cases it’s zero. So once that out of pocket gets hit on a Medicare patient, the copay for a preferred drug, which we are, is zero.

And so to me that is just, you know, fuel on a fire for being able to grow this drug.

Unidentified speaker: So you haven’t provided guidance, but what’s the right way to measure success looking forward in coming quarters? Is it, you know, double digit? Is it is it, you know, 10%, fifteen %? And I know you’re not gonna give me an exact number, but just give me second.

Unidentified speaker: It’s nice to try though. No. But I mean, I think you’re thinking about it the same way we are. We think this is a very durable growth drug. Right?

If you look at some of the analogs that we have in the cardiovascular space, you know, it’s that consistent growth all the way through LOE to be honest. And that’s why we, you know, we are fully committed to making this a blockbuster drug. And by showing that, you know, 10 to 15 or consistent growth that gets us there and, you know, we can we expect to continue to see that basically up until the point that generics come in.

Unidentified speaker: And so tie that back into how you think about investing in the brand from from the commercial organization. Will you Is it right sized today? Are there opportunities to build as the product grows?

Unidentified speaker: So we we think we’re in a very good place from both the spend standpoint and from the size of the Salesforce, the size of the infrastructure supporting that. I you know, there’s always opportunities to assess new, investment. However, I will say that will likely come as a reallocation of less effective investments. So we meticulously track the effectiveness of every dollar we spend. And I wouldn’t say necessarily increasing that commercial spend, but more reallocating it to something that we think might be more effective.

Unidentified speaker: Can we talk about loss of exclusivity a little bit? So, walk us through the patents that you have listed in the orange book. And, of course, like everybody would expect, there are ANDA filers already. So just walk us through the next steps there, the timelines with with that process.

Unidentified speaker: We had nine ANDA filers and we say we were very flattered. Okay. The nine people would wanna make this. Yeah, we have solid IP until middle of twenty thirty one. Mhmm.

And that’s, you know, composition of matter with a PT adder extension gets us to June of twenty thirty one. To your point, the ANDA filers came in last year, I believe it was. Nine filers and we are in the process of that, which honestly, we see more as an opportunity.

Unidentified speaker: Mhmm.

Unidentified speaker: So we also have patents that go till 2040. Those are, you know, formulation patents, and we think that there’s an argument to be made that we can extend past 2031. We won’t see the trial is 2027 for the for the the generics litigation. But so that’s I would say when we would expect to have full resolution on this. And it’s, you know, we’re confident that we will get something, but we’ll have to see what that is.

Unidentified speaker: Great. Okay. So let’s talk a little bit about continued life cycle management, label extension opportunities. One thing that you’re doing right now is looking at triple combinations with statins. Can you just walk us through that program?

Unidentified speaker: Yeah. So, we announced back at the year end earnings call that we were pursuing a triple combination in The United States. This would be bempedoic acid, ezetimibe, and, one or two different possible statins. You know, the reason we’re doing this is is we think one, this would be the single most efficacious LDL C drug on the market. We’re looking at anywhere 70% LDL C reduction.

All three of those have proven outcomes, and would be a tool that physicians could use where it would just be an adherence play, right, because everyone would just have one pill and you know, you’re a goal. And a copay benefit. Exactly. And and I think one of the other things is when you look at bempedoic acid has a lot of mitigating factors that kind of knock back the negative side effects of a statin like increasing glucose. We actually slightly decrease it.

So, HSCRP benefits would be tremendous in this pill. And if you look at a lot of the way that physicians are thinking about treatment, it’s these combination pills are becoming much more invoke, I guess would be the way to think about it. So we think this is way that we can kind of get ahead of that shift in prescribing dynamics and have an option that would be very in line with where the course of treatment is going.

Unidentified speaker: Got it. Okay. So how did you pick the statins that you you were moving forward with?

Unidentified speaker: So we wanted drugs that would work well together in a pill form but would also be synergistic with what we have. And I’m gonna very choose my words very closely. We will debut a lot more in the second half of this year. But it it was a very concerted effort, and, you know, well thought through.

Unidentified speaker: Got it. You’ve also you’re also, pursuing development in, in in, sorry, familial hypocholesterolemia. Can you just walk us through that rationale? You obviously had some of those patients in the phase three program originally. Yeah,

Unidentified speaker: so we are going through a pediatric trial, which is the the main driver of that is that six month extension at the end with the FDA. We are moving into a phase three. It’s progressing along very nicely. And, you know, we think that that is a real driver of, you know, six months at peak revenue is a big driver value for this company. Okay.

Unidentified speaker: So a few weeks ago at your R and D Day Analyst Day, you you rolled out a new program in PBC. Can you just, you know, give us a little bit of the the the details there? It’s it’s a mechanism clearly you know well and are and are leveraging, but just just help us understand why you chose PBC, what the rationale for the mechanism is.

Unidentified speaker: You’re gonna make the accountant talk science.

Unidentified speaker: That’s really

Unidentified speaker: good. So, yeah. No. It’s it’s we’re very excited about this. It it that R and D day, think, was a very big capstone for this company Because it’s something that we’ve been talking about for years, but have not been able to talk about externally, up to that point.

And something we’re very excited about. Right? So for a bit of context, this is our next generation ATP citrate lyase inhibitor. So it is a separate compound altogether from bempedoic acid, ESP one three three six. We’re looking to pursue in PSC primary sclerosing cholangitis, practice that a lot.

And it’s an area that we’re very excited. There are currently, you know, no treatments available for this very, very terrible disease. And I think you heard on, at the R and D day, one of the physicians said, you know, he has treatments at twenty five years ago. He had nothing and now it’s basically, you give them a pill and they’re done. But with PSC, it’s the exact same conversation as it was twenty five years ago.

So we’re we’re very excited about that. We think that this is an area that, again, a very unmet need. We think it’s a billion dollar opportunity, and we’re going to continue moving this asset forward. We’re currently working on sort of the IND enabling work that needs to happen there. And I think if you look at our deck, you have our timeline on there, but we think this could coincide nicely with that 2031 date that I mentioned in terms of being able to to launch and have the next step in evolution of Asperion.

Unidentified speaker: So let’s get back to a more accounting focused question. So one of the things that you, I I think really were successful at last year was, cleaning up the capital structure of the balance sheet. So just just walk us through those those few transactions and where where we sit today.

Unidentified speaker: Yeah. So we entered last year with about $700,000,000 in debt, which was just astronomical would be the way to put it. We did two, I would say, tranches of deals. One of which was we monetized a royalty stream with our partner Daichi Sanko and used that to remove a, you know, senior creditor royalty agreement that we had, a royalty purchase agreement. And then later down the line, we had about 265,000,000 in convertible notes that were outstanding, and we’re able to refinance 80% of those.

So now rather than having 265,000,000 due in November of this year, it’s now deferred down to 2030, I believe, the date. So, it’s a much cleaner story on the capital structure side. It was a busy year, but I think we’re in really set the stage nicely for being able to just focus on launch this year Yep. And grow this drug and and also look at some of the, you know, I’ve met we’ve mentioned before we’re looking at BD opportunities for how we can add something else in the bag. None of that could have happened with the cap structure we had last year.

So

Unidentified speaker: So so let’s talk about that a bit. What from a BD perspective, what’s your focus? What are your priorities? What would you not touch?

Unidentified speaker: Yeah. Yeah. So we you know, I mentioned before we have this legitimate organization, a commercial enterprise. There are a lot of companies that could leverage that. Right?

You know, there there are companies that are single product. They are either about to have a PDUFA. They just finished a phase three. They’re near commercial, and they are not they don’t have the infrastructure needed to launch a drug. And so there’s a lot of synergy that could be had with us and that we already have everything.

Have a sales force, you have a marketing or compliance, something that, you know, a lot of people don’t think about. There’s a lot of things that need to go on behind the scenes. And, you know, I I in today’s, you know, macroeconomic world, to raise money and start a commercial organization would be very difficult. And so we’ve been doing a landscape analysis. We’ve got, a few paths forward, I would say, on drugs that, like I said, are about to launch.

They need that commercial infrastructure. And what we’re looking at is things that, you know, I would say cardiometabolic, just because that’s where we play, but things that make sense from our from our call deck. So things either primary care or cardiologist setting that it would make sense from a marketing transition. Right? It’s hard to go talking about lipids to, yeah, let’s talk about asthma now.

Yep. But you know, let’s talk about lipids, let’s talk about heart failures, talk about, you know, kidney, liver, a lot of the things that are in a similar setting. That’s where we’re kind of looking at something that would make sense from a commercial perspective for us to put in the bag that we could, you know, leverage the existing field force for.

Unidentified speaker: And are you open to different structures? Like, you would you consider a co promote with somebody? Absolutely.

Unidentified speaker: Yeah. Yeah. I mean, I think there’s any number of ways we could take this and I think all of it is sort of incremental to what we have. We’re we’re looking at things that we wouldn’t necessarily need to add a to the cap, the cost structure to support and could just be an easy top level grab on like a co promoter revenue share, and, you know, easily sort of see the combine the two to.

Unidentified speaker: So, just going back to cash, can you remind us where we are today? You have given expense guidance so we got we got a sense there, but just how you think about, what the the, the platform needs to do to get to on a trajectory to cash flow breakeven.

Unidentified speaker: Yeah. I think we’re in a very good position when it comes to cash, all because of a lot of the work we did last year. I think we ended q one of about a hundred and $14,000,000, and you can see the trajectory that we’re on that, you know, sort of net burn every quarter gets less and less as the year goes on. So I think we’re in a great position on cash. I will also mention another big catalyst for us, the Japanese regulatory process is underway.

You know, associated with that is a number of milestones as they get approval and pricing. We expect that in the second half of the year. So it’d be another tailwind to to get us to that cash flow breakeven, point.

Unidentified speaker: So so you have the partner in in Europe and you’ve you’ve monetized that royalty. There is some back end upside as as well potentially, but what about, other, ex US geographies and and and plans

Unidentified speaker: So Japan, I mentioned that should launch in the second half of this year. We know it’s literally hot off the presses this morning, a partnership with HLS Therapeutics in Canada. They will help us launch in Canada, which I think that also is on track for approval in the second half of this year. The that one also has about a 50,000,000 in various milestones associated with it. On top of that, we partnered in Israel, Australia.

I would say we’re actually pretty well set up globally to make sure that bempedoic acid is a strong franchise across the globe.

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