Okay, welcome back, everybody. My name's Joe Pantginis, 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. It is very refreshing in the small cap biotech space, which you don't necessarily apply to. Presenting for the company is Ben Halladay, Chief Financial Officer. Ben, thank you for being here very much. I'm just going to dive right in.
Happy to join.
You have sales. So your lead product, obviously, is NEXLETOL, NEXLIZET. Off of your recent first quarter call, you know, how are your revenues tracking both in the U.S. and ex-U.S.? Obviously, it's a U.S. focus right now for you, and we'll talk about the ex-U.S. later as well. Can you give us a quick snapshot after your traction about the actual target population for NEXLETOL, NEXLIZET and how you could look to expand on that?
Yeah, happy to. And first off, Joe, thank you for having us here. I'm always excited to get on a stage and talk about this Company. You know, I was hoping we were the only commercial stage Company, but, you know, we'll share that spotlight with one other. Q2 is off to a great start, to be very honest. Q1, we saw some headwinds. I think you saw on the earnings call when that was not specific to us, right? Some Medicare headwinds that in an overall down market, we still were able to show some growth and get some good traction there. Those headwinds are far beyond us now, and we're doing quite well Q2. 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 copay issues that we saw in early Q1 were, you know, some of the Medicare patients had $100+ copays. Those are now down to, you know, call it $0-$40, which I'm excited about. We've never really ever seen a $0 copay. I think we're doing, we're doing quite well going through Q2 here. Talking about Europe, you know, they consistently execute and have done quite well since launch. I’d say this is shaping up to be a very good time for Esperion.
No, fantastic. I appreciate that. And then, you know, maybe just a quick reminder of your current target population for NEXLETOL, NEXLIZET, and how you might look to expand on that in the U.S.
Yeah, so backing it up a little bit, we received our expanded label in April of last year, which now included cardiovascular outcomes for both primary and secondary prevention, making us the only non-statin indicated for primary prevention. We started back in the middle of March a very targeted focus on the statin intolerant patients. So those who either can't take a statin at all or those who can only take a low-dose statin, in both cases, still need to get to their LDL-C goals. It's about a 70 million patient population in the United States, and we've been very focused 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've been, they've been looking for a tool in the space for quite some time.
Previously, it's been statins only and ezetimibe, even though not technically indicated for it. They've been very happy to now have an additional tool in their toolbox.
Nope, that's great. I appreciate that. 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?
Yeah. So very specifically, you know, the sales pitch is, is simple. Walk into a doctor's office, say, we know 30% of the people sitting in your lobby right now are statin intolerant. 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 40% 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.
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. Now, I think we're up to 190 million lives in the U.S. are both on the new label and in some cases don't even have a prior authorization. In the case that they do, it's electronic lookback, it's attestation, it's not this doctoral thesis that physicians had to write before. We still see some hangups 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. They do sometimes have this hangup from the former payer landscape, and we're helping them get past that and understand it's changed significantly.
No, that's good to hear. If I hear you correctly too, really it's the payers and insurance or what have you for the headwinds, if you will. Like you said, doctors love the drug. For the remainder of the physicians, it's really just a continued learning curve to understanding and knowing the product.
Exactly. I think once you, once a physician writes this and sees, oh, this was actually really easy, that really opens up the floodgates. 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 12 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. You have physicians who now know the target population to write. They're seeing how easy it is to get. 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.
No, fantastic. Looking towards ex-U.S., I'm going to look towards today and forward.
Great.
Not looking at, you know, 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 ball game 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 welcome.
I'm happy to talk on their behalf. They have consistently grown every quarter -after- quarter. You know, Europe is a different dynamic in 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. They have gotten to the point now where I believe in Germany, you cannot try a PCSK9 unless you have stepped through bempedoic acid. There, which is the largest market in Europe, they have consistently shown 20%-30% growth every single quarter. 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.
Just threw the gauntlet down.
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. Having that option of one pill, you know, is just really going to continue to fuel that growth going forward. They're definitely leading the charge on that.
Before we continue on the ex-U.S. component, can you also talk about your plans for a triple combination?
Yeah. We announced back in, I believe it 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 kind of leveraging a lot of the same work. We are not duplicative here. You know, I think we will unveil more as the year goes on, but we are looking at bempedoic acid, ezetimibe, and two different statins. The two most commonly prescribed are atorvastatin and rosuvastatin. I myself am on rosuvastatin. You know, that really gives physicians one-stop shop. What would be the single most efficacious LDL-C pill on the market? We are talking 70%-80% LDL-C reduction in one single pill, which would just be a massive adherence benefit to patients. The payers would love it because it is, you know, again, just one reimbursement landscape.
We're working on kind of the, the path to market on that. It's a bioequivalent study. It's not a Phase 3. You know, not a lot of expense associated with it. We think probably sometime 2027 this could be on the market. We're excited about it too. If you look at a lot of the literature that's coming out, people are talking about kind of polypills and multiple treatment options to address one disease. We see that in blood pressure. We see that in diabetes. I think cardiovascular is kind of catching up to that, that landscape. We'll talk more about that towards the second half of the year. Again, we're very excited about it in the U.S. as well.
No, that's great. I appreciate you addressing that little tangent of mine. Going back across the 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?
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 commercializing this in Japan. They filed their JNDA, I believe, in November of last year. 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 $130 million 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 recently announced agreements with HLS in Canada, which is a big market. We did the filing ourselves earlier this year or late last year. Can't even quite remember. That is also set to launch later this year. They will be kind of commercializing it. A similar arrangement as Daiichi Sankyo, in Canada. I believe there's $50 million in milestones associated with that agreement as well. Smaller agreements, CSL in Australia, and Neopharm in Israel. It's been a lot of agreements recently.
No, that's awesome. I'll preview that, you know, you have all these potential milestones coming in there and we'll sort of link it to 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 a little bit later on. When you talk about having an approved product, and of course, you know, the statins are generic, little preview there, you recently announced a settlement agreement with Micro Labs regarding their ANDA for generic NEXLETOL. Excuse me. Can you talk about the terms here, if they've been disclosed, any other potential ANDA filers that could be viewed as future risks, and how does this jive with the current patent portfolio of NEXLETOL and NEXLIZET?
The short answer is no. It's a very confidential process as I'm learning here.
Thanks for that one, John.
Yeah, I mean, I will address what we put out in the press release. You know, we think that there's a good opportunity to get patent extension past 2031. Our current composition of matter with a pediatric extension puts us in June of 2031. You know, we think we have a very good argument in the end of litigation that could get us to 2040 based on some other patents that we have around the manufacturing. I think this settlement that we had, that we announced last week, is the first time that we've been able to demonstrate, like, yeah, there's something here, guys. Like, this is not just us saying this. We kind of see this as the precedence for how we'll approach the other conversations. There's still eight other ANDA filers to work through.
But, you know, obviously they saw something with this 2040 patent that we've also been saying there's something with this 2040 patent, and we'll continue to make announcements as they come out. But, you know, we think there's a good opportunity to expand patent past 2031 here.
Good to hear. Good to hear. And something you always have to face in this industry. It seems like you've approached it in a nice way.
It's an opportunity 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 going to come before 2031. I think it's more of an opportunity to add on the years. And frankly, adding on two, three, four, five, even nine years fundamentally reshapes the DCF on this Company.
Actually, going back a little bit, if you add the triple combination, that should add further patent protection and the life cycle extension.
It does in the sense that the same manufacturing would apply to the triple combination. It's not like Europe, Europe receives a patent, will receive a patent extension based on just the triple combination, IP in and of itself. Whereas in the U.S., it's a little bit different dynamic. It's more, we'll have that same manufacturing protection with the triple combination as we have with the other products. It adds more fuel to that fire, but it's not necessarily we would have additional composition of matter or, you know, call it some formulary extension from 2031.
Appreciate those comments for the growth of the NEXLETOL franchise. Switching gears a little bit, you recently held an interesting R&D Day, where you introduced the lead optimization stages for molecules targeting what's called primary sclerosing cholangitis or PSC.
I'm glad you said it. I didn't have to say it.
We'll just stick with PSC. First off, can you share what that is and what the clinical issues that patients face? Are there any drugs available for PSC right now? Where would you fit?
Yeah. PSC is a nasty disease. If you pull up our R&D Day presentation, you'll see some patient testimony 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. 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. You know, we're very excited about it. We think there's a lot of opportunity here.
This is a rare disease orphan space, which is a 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 bempedoic acid started and was sort of fortuitously discovered. But now we've really started learning about what that therapeutic potential can be and be able to target it in areas that, you know, out, or outside of cardiovascular. And I will clarify very, this is, we're not just using bempedoic acid to treat PSC. This is a whole new compound, ESP1336, that we fully own the patent life or the IP on globally.
It's, 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 with coming to market right around that time. 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.
No, great. And can you share any early thoughts with regard to timelines and what the clinical programs might look like? And then I'm going to loop back my earlier comment about cash infusions to be able to run this as the Company grows and you also look towards profitability.
Yeah, I, 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 ESP1336 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. 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 R&D Day, 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 in flux in the middle there. When we talk about profitability, we're almost there.
We have shown a growth trajectory and cost control in that growth trajectory that I think we are, we're going to be there in the very near term. 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 going to 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 the second half of the year, which absolutely plays into keeping that engine rolling, keeping this catalyst going. You know, I think we're in great shape when it comes to our trajectory for profitability, when it comes to our cash position. We're plugging along and we're going to keep executing here to get there.
No, I appreciate that. I guess it's very refreshing to be able to be talking about the verge of profitability, especially in this market environment. Ben, thank you for all the thoughts and good luck with the continued growth.
Appreciate it. Thank you.