Esperion at H.C. Wainwright Conference: Strategic Growth and Future Plans

On Tuesday, 20 May 2025, Esperion Therapeutics (NASDAQ:ESPR) presented at the H.C. Wainwright 3rd Annual BioConnect Investor Conference 2025. The company highlighted a positive outlook, emphasizing strong prescription growth and strategic international partnerships. However, challenges with payer landscapes and market headwinds were also noted.

Key Takeaways

• Esperion’s Q2 prescription growth exceeded expectations, driven by improved Medicare co-pay dynamics.
• The company is targeting the statin-intolerant population, with a focus on primary care.
• International partnerships with Daiichi Sankyo, Otsuka Pharmaceuticals, and others are expected to boost future revenues.
• Esperion is advancing its pipeline, particularly ESP1336 for primary sclerosing cholangitis, aiming for a launch in the early 2030s.
• The company anticipates reaching profitability soon, with self-funding capabilities for pipeline development.

Financial Results

• Q1 2024 faced challenges from Medicare headwinds and a market downturn but still showed growth.
• Q2 2024 started strong, with prescription growth surpassing expectations since mid-March.
• Medicare co-pays decreased significantly, benefiting patient access and prescription rates.
• European market growth is consistent, with Daiichi Sankyo reporting 20-30% quarterly growth.
• Profitability is expected in the near term, supported by milestone payments in the second half of the year.

Operational Updates

• Esperion targets statin-intolerant patients, focusing on primary care settings.
• The expanded label for cardiovascular risk reduction is well-received by physicians.
• The company has deployed 15 field reimbursement managers to assist with prior authorization processes.
• A triple combination product is in development for the U.S., with an expected launch around 2027.
• Anticipated product launches in Japan and Canada are set for later this year.

Future Outlook

• Esperion is working to extend patent protection beyond 2031.
• The U.S. triple combination product, including bempedoic acid, ezetimibe, and a statin, is targeted for a 2027 launch.
• The ESP1336 drug for primary sclerosing cholangitis could potentially generate over a billion dollars, with a launch expected in the early 2030s.
• Partnerships with Otsuka Pharmaceuticals, HLS, CSL, and NeoPharm are key to international expansion.

Q&A Highlights

• The payer landscape is improving, though some access issues remain.
• Physicians appreciate the ease of prescribing Nexletol/Nexlaze, aiding adoption.
• A settlement with MicroLabs strengthens Esperion’s patent litigation stance.
• The PSC drug development is expected to be self-funded, highlighting Esperion’s confidence in its financial strategy.

For the full transcript of the conference call, please refer to the document below.

Full transcript - H.C. Wainwright 3rd Annual BioConnect Investor Conference 2025:

Joe Panginas, Managing Director, HC Wainwright: Okay. Welcome back, everybody. My name’s Joe Panginas, managing director here at, HC Wainwright. Very happy to have with us Esperion Therapeutics.

And, also nice to have the second commercial stage, company that I’m, doing a fireside chat with today. So it’s very refreshing in the small cap biotech space, which, you don’t necessarily apply to. So presenting for the company is Ben Halliday, chief financial officer. Ben, thank you for being here very much. So just gonna dive right in.

Fact that you do have sales. So your lead product, obviously, is NEXLETOL, NEXLASET. Off of your recent first quarter call, you know, how are your revenues tracking both in The US and ex US? Obviously, it’s a US focus right now for you, and we’ll talk about the ex US later as well. Can you give us a quick snapshot after your, traction about the actual target population for Nexletol and Nexelazet and how you could look to expand on that.

Ben Halliday, Chief Financial Officer, Esperion Therapeutics: Yeah. Happy to. And and first off, Joe, thank you for having us here. I’m always excited to get on a stage and talk about this company. And, yeah, I was hoping we were the only commercial stage company, but, you know, we’ll share that spotlight with one But q two is off to a great start to be very honest.

Q one, we saw some headwinds. I think you saw in the earnings call when that was not specific to us, right? So Medicare headwinds that in an overall down market, we still were able to show some growth and get some good traction there. But those headwinds are far beyond us now, and we’re doing quite well q two. I think around mid March, we started to see the prescription growth pick up to levels that actually started exceeding expectations.

A lot of the co pay issues that we saw in early q one where know, some of the Medicare patients had hundred dollar plus co pays. Those are now down to, you know, call it 0 to $40, which I’m excited about. We’ve never really ever seen a $0 co pay, and I think we’re doing we’re doing quite well going through q two here. Talking about Europe, you know, they consistently execute and have done quite well since launch. And so I’d say this is shaping up to be a very good time for Spirion.

Joe Panginas, Managing Director, HC Wainwright: No. Fantastic. I appreciate that. And then, you know, maybe just a quick reminder of your current target population for Nexletol and Nexlez and how you might look to expand on that in The U. S?

Ben Halliday, Chief Financial Officer, Esperion Therapeutics: Yeah. So backing it up a little bit, we received our expanded label in April of last year, which now included cardiovascular

Joe Panginas, Managing Director, HC Wainwright: States, and we’ve been very focused

Ben Halliday, Chief Financial Officer, Esperion Therapeutics: on

that statin intolerant on that statin intolerant population largely in the primary care setting. And it’s it’s, you know, resounded very well with physicians. I think they’re been they’ve been looking for a tool in this space for quite some time. Previously, it’s been statins only and ezetimibe even though not technically indicated for it. And they’ve been very happy to now have an additional tool in their toolbox.

Joe Panginas, Managing Director, HC Wainwright: That that’s great. I appreciate that. So maybe a question that focuses on, the trenches and your sales Salesforce, if you will, and the detailing that they’re doing. You know, what kinds of anecdotes, learning curves, things of that nature is the Salesforce and Field Force experiencing from prescribers to be able to build out?

Ben Halliday, Chief Financial Officer, Esperion Therapeutics: So very specifically, you know, the sales pitch is is simple. Walk into a doctor’s office, say, we know thirty percent of the people sitting in your lobby right now are statin intolerance. How many of them need to get to LDL C goal in order to not be at risk of a cardiovascular event? Why should we wait until they’ve had the heart attack to try and prevent the next heart attack? That’s where the primary prevention comes in, and the data is extremely compelling, upwards of forty percent MACE reduction in a primary prevention setting.

So, you know, this is I think, like I said, it’s gone very well with physicians. You know, the only pushback we’ve received is largely on the payer side, and that’s more before we had expanded access on the label. So post label, we did a very strong blitz with the payers to get them on board with both the new label as well as reducing what was a very burdensome prior authorization process. And now for, I think, it’s for up to a hundred ninety million lives in The US are both on the new label and in some cases don’t even have a So and when in the case that they do, it’s electronic look back, it’s attestation, it’s not this doctoral thesis that physicians had to write before.

So we still see some hang ups on access, but we recently deployed 15 field reimbursement managers to go out there who are solely focused on walking the offices through whatever prior authorization process there might be, those plans that they don’t, and just helping them navigate that payer landscape because clinically, the doctors love this drug. It’s tolerable. It has great outcomes. It has great effect, But they do sometimes have this hang up from the former payer landscape, and we’re helping them get past that and understand it’s changed significantly.

Joe Panginas, Managing Director, HC Wainwright: No. That that’s good to hear. So if I hear you correctly too, so really it’s the payers and insurance or what have you for the headwinds, if you will. And then, like you said, doctors love the drug. And for the remainder of the physicians, it’s really just a continued learning curve to understanding and knowing the product.

Ben Halliday, Chief Financial Officer, Esperion Therapeutics: Exactly. And I and I think once you once a physician writes this and sees, oh, this was actually really easy, that really opens up the floodgates. And I think one of the main reasons that we’ve seen a lot of the great growth recently since mid March is if you look at the new prescribers, so those who have not written this drug in, you know, the last twelve months, I believe, that the amount of new prescribers per week has doubled and I think in some ways even tripled from before the statin intolerance blitz. So you have physicians who are now know the target population to write, they’re seeing how easy it is to get, and once you have a new writer then they continue to expand within that adjunct market and add additional prescriptions on top of what they’ve already been writing.

Joe Panginas, Managing Director, HC Wainwright: No. Fantastic. So looking towards ex US, I’m gonna look towards today and forward. Great. So not looking at you in the past, but obviously, you’ve had a, you know, call it a smoothed out relationship with Daiichi.

You know, things are looking very nice. And, you know, obviously, Daiichi is running the ballgame in Europe. Can you comment on their expansion of the drug and geographical traction? Even though, of course, I know we should ask them directly, but any comments here would be one.

Ben Halliday, Chief Financial Officer, Esperion Therapeutics: I’m I’m happy to talk on their behalf. They, they have consistently grown every quarter after quarter. You know, Europe is a different dynamic and that the access that we now have, they’ve effectively had since launch with the way that the reimbursement landscape is set up over there. And so they’ve, you know, they’ve gotten to the point now where I believe in Germany, you cannot try a PCSK nine unless you have stepped through bempedoic acid. So there which is the largest market in Europe.

They’ve consistently shown 20 to 30% growth every single quarter, and we’re catching up with them. I think we will surpass them ultimately, but I think they’ve just demonstrated great growth in Europe. And they’re

Joe Panginas, Managing Director, HC Wainwright: Just threw the gauntlet down.

Ben Halliday, Chief Financial Officer, Esperion Therapeutics: That’s yeah. They and they’re very excited for the triple combination. I think they’re currently marketing it as a triple combination just in two pills. And so having that option of one pill, you know, it is just really gonna continue to fuel that growth forward, and they’re definitely leading the charge on that.

Joe Panginas, Managing Director, HC Wainwright: Be before we continue on the ex US component, can you also talk about your plans for a triple combination?

Ben Halliday, Chief Financial Officer, Esperion Therapeutics: Yeah. So we announced back in, I believe, was year end earnings that we will also be developing a triple combination in The United States. This is kind of piggybacking off the work that Daiichi Sankyo is doing and and kind of leveraging a lot of the same work, so we’re not duplicative here. You know, we’re I think we’ll unveil more as the year goes on, but we’re looking at bempedoic acid, ezetimibe, and two different statins. So the two most commonly prescribed are atorvastatin and rosuvastatin.

I myself am on rosuvastatin. And, you know, that really gives physicians one stop shop what would be the single most efficacious LDL C pill on the market. We’re talking seventy to eighty percent LDL C reduction in one single pill, which would just be a massive adherence benefit to patients. The payers would love it because it’s, you know, again, just one reimbursement landscape. And we’re working on kind of the the path to mark on that.

It’s a bioequivalent study. It’s not a phase three, so, you know, not a lot of expense associated with it. And we think probably sometime 2027, this could be on the market. And we’re excited about it too. We if you look at a lot of the literature that’s coming up, people are talking about kind of polypills and, multiple treatment options to address one disease.

We see that in blood pressure. We see that diabetes. I think cardiovascular is kind of catching up to that that landscape. And so we’ll talk more about that towards the second half of the year here. But, again, we’re very excited about The US as well.

Joe Panginas, Managing Director, HC Wainwright: No. That’s great. I I appreciate you addressing that little tangent of mine. So going back across pond, if you will, you also have other geographies that are being addressed by different partners. Can you summarize and also give a sense of what else might be coming down the road for them?

Ben Halliday, Chief Financial Officer, Esperion Therapeutics: Yeah. It’s been a pretty big blitz of international agreements now that I think about it. So kind of going back more historically, Otsuka Pharmaceuticals is is commercializing this in Japan. They filed their JNDA, I believe, in November of last year. It’s, it’s about a nine month regulatory process there, so we expect that to wrap up in the second half of this year they’ll be launching.

There are a number of milestones associated with that up to a hundred and $30,000,000 based on regulatory outcomes that could come out of that. And I will tell you they’re very excited about this. They have, I think, 500 people working on this in Japan. It’s a very underserved population that tends to be more statin intolerant. So they did a bridging trial that really reiterated that this is effective in that population, and they’re excited about it.

We also had just recently announced agreements with HLS in Canada, which is a big market. We did the filing ourselves earlier last or earlier this year or late last year, can’t quite remember, but that is also set to launch later this year. They will be kind of commercializing it. This similar arrangement is Daichi Sankyo in Canada, and I believe there’s 50,000,000 in milestones associated with that agreement as well. Smaller agreements, CSL in Australia and NeoPharm in Israel.

So it’s been it’s been a lot of agreements recently.

Joe Panginas, Managing Director, HC Wainwright: No. That’s awesome. And and we’ll just sort of I’ll preview that, you know, you have all these potential milestones coming in there, and we’ll sort of link it to, you know, your path towards profitability overall for the company as well as how these milestones and your overall cash growth could be applied to the pipeline, which we’ll discuss

Ben Halliday, Chief Financial Officer, Esperion Therapeutics: Yeah.

Joe Panginas, Managing Director, HC Wainwright: A little bit later on. So when you talk about having an approved product, and of course, know, the statins are generic, little preview there. You know, you recently announced a settlement agreement with MicroLabs regarding their or the a the ANDA for generic Nexlotol. Can you talk about the terms here if they’ve been disclosed, any other potential NDA filers that could be viewed as future risks? And how does this jive with the current patent portfolio of NEXLASET?

Ben Halliday, Chief Financial Officer, Esperion Therapeutics: So the short answer is no. It’s a very confidential process as I’m learning here.

Joe Panginas, Managing Director, HC Wainwright: Thanks for that one, But

Ben Halliday, Chief Financial Officer, Esperion Therapeutics: I mean, will address what we put out in the press release. So we think that there’s a good opportunity to get patent extension past 02/1931. Our current composition of matter with a pediatric extension puts us in June of twenty thirty one. You know, we think we have a very good argument in the end of litigation that could get us to twenty forty based on some other patents that we have around the manufacturing. And think this settlement that we had with with, that we announced last week is the first time that we’ve been able to demonstrate, yeah, there’s something here, guys.

Like, this is not just us saying this. And we kind of see this as the precedence for how we’ll approach the other conversations. So there’s still eight other, you know, ANDA filers to to work through. But, you know, obviously, they saw something with this twenty forty patent that we’ve also been saying there’s something with this 2040 patent, and and we’ll continue to make announcements as they as they come out. But, you know, we think there’s a good opportunity to expand patent past 2031 here.

Joe Panginas, Managing Director, HC Wainwright: Good to hear. Good to hear. And something you always have to face in this industry, so it seems like you’ve

Ben Halliday, Chief Financial Officer, Esperion Therapeutics: It’s it’s an more than a risk, I think. And so, you know, we think that the 2031 patents are extremely solid. And frankly, in my mind, I would be I don’t think anything’s gonna come before 2031. I think it’s more of an opportunity to add on to years. And and frankly, adding on two, three, four, five, even nine years fundamentally reshapes the DCF on this company.

Joe Panginas, Managing Director, HC Wainwright: And actually going back a little bit, if you add the triple combination, that should add further patent protection in the life cycle extension.

Ben Halliday, Chief Financial Officer, Esperion Therapeutics: It does in the sense that the same manufacturing would apply to the triple combination. It’s not like your Europe receives a patent will receive a patent extension based on just the triple combination IP in and of itself. Whereas in The US, it’s a little bit different dynamic. It’s more we’ll have that same manufacturing protection with a triple combination as we have with the other products. So it adds more fuel to that fire, but it’s not necessarily we would have addition to composition of matter or, you know, call it some formulary extension from 2031.

Joe Panginas, Managing Director, HC Wainwright: Appreciate those comments for the growth of the Nexotol franchise. So switching gears a little bit, you recently held an interesting R and D day, where you introduced the lead optimization stages for molecules targeting what’s called primary sclerosing cholangitis

Ben Halliday, Chief Financial Officer, Esperion Therapeutics: or PSC. I’m glad you said that and I didn’t

have

Joe Panginas, Managing Director, HC Wainwright: to say it. Absolutely. We’ll just stick with PSC. First off, can you share what that is and what the clinical issues that patients face? And are there any drugs available for PSC right now and where would you fit?

Ben Halliday, Chief Financial Officer, Esperion Therapeutics: Yeah. So PSC is a nasty disease. And if you pull up our R and D Day presentation, you’ll see some patient testimony in there that really speaks to how personal and difficult it is to live with this disease. It’s progressive. The current treatments out there really only slow down the progression.

They don’t necessarily stop it or reverse it. And your options ultimately end up being a liver transplant or death. And to us, that is a very unmet need to have something in this space that can actually help cure the disease and prevent that liver transplant in the long term. So we’re very excited about it. We think there’s a lot of opportunity here.

This is a rare disease orphan space, which is shorter path to market, a cheaper path to market, but it still represents a billion dollar plus opportunity for the company. So, you know, this is kind of the the next step evolution of ATP citrate lyase inhibition, which bepedoic acid started and was sort of fortuitously discovered. But now we we’ve really started learning about what that therapeutic potential can be and be able to target in areas that, you know, out or outside of cardiovascular. And and I will clarify various this is we’re not just using bempedoic acid to treat PSC. This is a whole new compound, e s p one three three six, that we fully own the patent life or the IP on globally.

And it’s it I think it’s a huge opportunity that looking at the clinical timeline would coincide nicely with, I just mentioned, the 2031 date, coincide nicely coming to market right around that time. So it really shows the long term potential of this company and how we see that science as, you know, sort of the engine for this company.

Joe Panginas, Managing Director, HC Wainwright: Great. And and can you share any early thoughts with regard to timelines and what the clinical programs might look like? And then I’m gonna loop back my earlier comment about cash infusions to be able to run this as the company grows and you also look towards profitability.

Ben Halliday, Chief Financial Officer, Esperion Therapeutics: Yeah. I am my whole life has been in primary care setting. Okay? So I’m used to 14,000 patient outcomes trials and the price tag associated with those. And so when I started seeing the development plans for the PSC ESP one three three six drug, I kind of looked at that and said, yeah.

But what else is there? Because, you know, this seems like a footnote in what I’m used to. So I think it is a minimal cost that can provide a significant value to the company. And timeline, it’s early. You know, if you pull up the deck for our data, you’ll see we have some broad timelines that basically mean we’re preclinical now, and we expect to be launching in the early 2030s.

I think everything is pretty influx in the middle there. But when we talk about profitability, we’re almost there. And and we have shown a growth trajectory control in that growth trajectory that I think we are we’re going to be there in the very near term. And by the time we have to start funding some of this bigger stuff associated with the pipeline, profitability will be so far behind us that it’s not even gonna be an issue. This will be entirely self funded.

This will be something that we can invest in as needed. You mentioned the milestones coming in second half of the year, which absolutely plays into keeping that engine rolling, keeping this catalyst going. So I think we’re in great shape when it comes to our trajectory for profitability when it comes to our cash position. And we’re plugging along and we’re going to keep executing here to get there.

Joe Panginas, Managing Director, HC Wainwright: No. I appreciate that. And I guess it’s very refreshing to be able to be talking about the verge of profitability, especially in this market environment. So, Ben, thank you for all the thoughts, good luck with the continued growth.

Ben Halliday, Chief Financial Officer, Esperion Therapeutics: Appreciate it. Thank you.

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