Okay, welcome everyone. My name is Jennifer Kim. I'm a, one of the biotech analysts at Cantor. I'm happy to welcome Esperion Therapeutics for this fireside chat. We have with us Ben Halladay, CFO. Ben, thanks for joining us. Thank you for having me. Really appreciate the opportunity to represent Esperion here today and talk about the company. Yeah, maybe to start off, a lot has changed with the Esperion story. To start off, could you walk us through what's been going on and where Esperion stands today? Yeah, it's been a transformative year, is the only way to put it for Esperion. We, you know, we entered the year knowing that there were a lot of kind of, you know, landmark events ahead of us, and we've accomplished everything that we've set out to do so far. You know, most notably, we received the label expansion to include the cardiovascular outcomes data in our U.S. label. Europe was not far after that, which really was, you know, the start of what we call the relaunch of this drug. That label expanded our addressable population from a 10 million ASCVD-only population to 70 million addressable patients in the U.S. So that now includes not just ASCVD patients on a max tolerated dose of statin, but, I would say more importantly, it incorporates now primary prevention patients, so those who are at risk of a cardiovascular event. That brings us up to 70 million patients that we can now target and go after within the United States. You know, among other things, we've addressed capital structure issues over the course of the year. We've had some significant payer wins on the heels of that label expansion that I think everyone is extremely excited about and proud of the accomplishments we've done there, and it's really I'd say just the sky's the limit at this point. Okay. It would be great to place the label expansion in some context. So maybe to start off, could you review the data that supported that expansion? And then we'll go through the different levers that have changed, access, patients- Mm-hmm. prescriber behavior, all of that good stuff. Yeah. So we presented the CLEAR Outcomes data back at ACC in 2023. You know, the response was fantastic. I joke, I feel like a rock star at ACC that year because we were the talk of the town. You know, the data and the clinical data was very positively received, and doctors seemed thrilled about it. You know, some of the main points there, 23% reduction in you know, in fatal and non-fatal MI. You know, this was a 14,000-patient outcome study with a very diverse population. And you know, we continued to report out on major data from that trial over the course of the year. You know, in JAMA, later that year, we reported the primary prevention data that was a part of that subset population, which was, I believe, a 30% reduction in MACE-4 events within the primary prevention population, and all that went into the label. You know, we had both outcomes data included in both labels for NEXLETOL and NEXLIZET, which was important, something that wasn't necessarily a given, but that we had been working towards, you know, over the course of the year and, you know, we're very happy with. Okay, so if there are three periods I can cut into maybe before the data, after the data, and now with the data on label, can you walk through what's changed in terms of managed care, reimbursement, utilization management, and- Yeah. Yeah. Yeah, I'll make it a little easier. We'll talk about just pre-UM updates and post-UM updates. So, when we looked at the label coming out of it, it was a very broad cardiovascular label, but our indication prior to that was extremely narrow. So like I said, 10 million patients, and that was limited to patients that had ASCVD and were on a max tolerated dose of a statin. With the new label update and the ensuing payer changes, you know, that broadened significantly to include statin intolerance, the primary prevention population. And one of the largest headwinds that this drug had up until that label change was a very burdensome prior authorization process from the payers. I joke that, you know, doctors effectively had to write a second doctoral thesis in order to get this in the hands of their patient. One of the things that I have frankly just been blown away with is the changes that came with the new enhanced UM criteria and coverage. We had a large bolus of about a hundred million patients kick in on June 1st. And it's not just the, you know, the change to now cover the new label and the new population. With that came a much better UM process. So some payers went to even just as easy as an electronic look back, where they, you know, look in the system where they prescribed a statin within the last six months. If yes, it goes through. There's still a prior authorization in place for some physicians or some prescribing indications, but it's a much easier and more broad prior authorization that doesn't require as many hoops to jump through as it did before, so you know, the stigma of it is hard to get NEXLETOL and NEXLIZET was effectively changed overnight with these, you know, on June 1st, and we had another big uptick on September 1st as a lot more Medicare patients came online. Where's coverage at today, and how do you see that evolving? So now we have, I believe, it's one hundred and forty-four million patients in the U.S. covered under the new label and the new UM criteria. It's about 96% of the coverage that we're looking for. We're in very good shape and, you know, are ahead of schedule on where we thought the coverage would be at this point. Okay, and then, from a pricing perspective, do you see that evolving, as you maintain access? I think pricing will stay very consistent. So, you know, gross price that we talk about is not gonna change as a result of the new label. The net price that we receive, again, one of the things I was very pleasantly surprised with as the CFO was minimal to no concessions on the net price and the rebate side when it came to getting the new enhanced UM criteria, which is, you know, frankly, I've never seen happen before. Very happy with how that turned out. Okay, and then as far as changing prescribing patterns, how have you seen what has growth looked like since the label came online? So we've been very happy with the growth. I mentioned that June 1st, you know, payer update, we saw about 11% growth month- over- month between June and May, all driven by that payer access, and we've continued to build upon that new, you know, the new precipice of growth that we saw at that point. It'll continue to accelerate. You know, this is a very, very large market, and, you know, it's a flywheel, snowball, whatever, you know, analogy you wanna do. The longer it goes on, the more and faster that growth gets, and we're very excited for what's to come with it. Can you remind us what your S&M efforts have looked like, what your strategy is- Yeah. and what it will look like going ahead? So, January of this year, we increased our sales force. We went from, we had, depends on the day, between 65 and 70 reps, we went up to 155. That includes 5, what we call key account managers, which are sort of overlay sales reps in key targeted territories. So that was our, that was our kinda ramp up ahead of the label so that they would be in place and have the relationships ready to go by the time the label hit. We've also significantly bolstered our digital physician marketing. So if you wanna break that down in terms of touch points with prescribers, about our direct marketing hits about 20,000 key- targeted physicians, and that digital overlay hits those same 20,000+ an additional 20,000 physicians, so 40,000 physicians in total. We know at this point about 21,000 prescribers are prescribing NEXLETOL and NEXLIZET. And, you know, I will say with the digital marketing specifically, you know, we track very, very specifically the effect and ability to actually target and influence prescribing behaviors. And it's something that, again, has been very pleasantly surprising coming out of this launch, is how effective that's been. So it's, you know, we're a small but mighty force, and, you know, I think we have seen very good indications that the activities that we're doing are having a very strong effect on prescribing. The touch points, what is the distribution in terms of primary care and cardiologists? It's about 60% primary care, 40% cardiologists. I think with the new label, prior to the new label, it was all cardiologists, right? The ASCVD population was very concentrated in cardiologist practice. But with that primary prevention, that opens up the primary care doctor, and I'll note, we're seeing growth in both those categories, but the growth within the primary care space is, you know, significantly outpacing the cardiology space. On a percentage basis? On a percentage basis, yes. Looking down the line on, like, an absolute basis, where do you think it'll shake out? I think we'll probably land around about where we have the marketing effort, about 60-40 split. You know, again, we look at Zetia as an analogy. That's about where they landed. And but this is absolutely a primary care drug, and that's where that, you know, 40 million patient population in primary prevention, that's gonna drive most of the value for this franchise. Okay, and I think you've talked about guidelines evolving, and that has an important place in terms of changing prescribing behavior as well. Can you just remind us where we are with all of the guidelines? Yeah. So we're... Let me preface this, we're not allowed to talk to guideline writers, but, you know, they're, I think, starting to formulate when and how they'll look through their guideline updates. We expect that to be sometime next year, I would imagine. I mean, one of the best part about guidelines is it gets you the payer access, right? If you're on a guideline, that lets you go to the payers and say, "Put us where you see on the guidelines." I mean, I would say honestly, the benefit for us, we've already done that with the payers. We've kind of positioned ourselves where we'd like to be within that UM criteria, and so guidelines are important, but I think what they're most important for, we've frankly kind of already achieved through our, you know, what I would say, pretty aggressive payer negotiations. Can I ask, going back to the payers, sort of the levers that you have there to improve what you have today, is that coming from changing UM criteria? Is it expanding coverage and access? How do you think about that? Yeah, it's, I would say all of the above. You know, we were in pretty frequent contact with the payers between when we published the outcomes data and when we received the new label and then the new criteria, and you know, first comes a clinical sell, and I would say, going back to what I mentioned earlier, the clinical data from the CLEAR Outcomes trial was overwhelmingly positive and something that they could absolutely get behind. And then when it comes to having an additional resource and being able to show that we are a, you know, a low-cost alternative relative to like a PCSK9 or some of the other options out there, you know, that's a compelling story for a payer. And you know, that's, I think why we kind of came out of this with minimally enhanced rebates. It was largely on the access side and sort of patient cost-benefit analysis, essentially. Maybe touching on the patient side of things, where is the growth coming from? Is it coming from primary prevention patients, secondary? Yes. Yeah, it's the primary prevention that's driving most of our growth. And then in terms of their treatment history, are these coming from post-statin, post-ezetimibe, pre- or post-PCSK9s? Yeah. So I would say most patients will have been on a statin or are currently on a statin. Statins are the cornerstone of cardiovascular care, and candidly, we're not going to unseat statins. But when you look at the adjunct market, 300,000 prescriptions every single week in the adjunct market, ezetimibe is 65% of that. So that is a very, very large segment of business that we know who's prescribing ezetimibe, we know who's receiving ezetimibe, that we can go after and through that clinical sell, because remember, we have significantly better efficacy than ezetimibe and an outcomes benefit that ezetimibe does not have. That's a relatively, I would say, straightforward decision to replace us with eze- or replace ezetimibe with us, and sort of go after that market share, as opposed to either the statin or the PCSK9s, which PCSK9s are a very niche product for a niche patient who needs something at the very end of the line. You know, we see ourselves coming in well in advance of when a patient would try a PCSK9. Who are the users of NEXLETOL versus NEXLIZET? It varies. You know, we market NEXLIZET almost exclusively, just between the efficacy and you know, where we see the benefit coming from. There are some physicians who like to add on as opposed to give a combo product, and that's why we have that option available for both, but we fully believe that the future is in NEXLIZET. Okay, and then in terms of prescription growth, any thoughts on what that could look like over the next few quarters? Is it a steady growth or anything like that? I think it's up and to the right, kinda how we put it. I think what we've seen is just the tip of the iceberg in terms of the growth rates that we can achieve. Summer months are slow, you know, to be very blunt, and we, you know, got the label right before summer started, and everyone then went on vacation from a prescribing standpoint. So, we still managed to add on and accelerate that growth over the summer months, so I think we will continue to see an uptick, we'll continue to see an acceleration. Again, we're scratching the surface of what's available here, but, you know, we fully believe that these are blockbuster drugs in the U.S. To get to the levels that you're aspiring to, are your current investments in S&M? Are you happy with where you are right now, or do you see that growing? As a CFO, I'm very happy where they are. But, you know, we evaluate every single tactic that we do on a tactic-by-tactic basis, and if there is something that's either not performing the way we expect it to, we will take that money and reinvest it somewhere else, or if there's something that is showing significant returns, we'll actually increase the investments in those areas. I don't ever really see this company spending more than what we're on track to do right now, which is between $200 million and $210 million this year. But, you know, I think if we see areas that we know for a fact can generate a return and an immediate return, we will invest in those areas, I think. But for right now, this is a good, healthy level for the company. Then, maintaining this healthy level, how should we think about ultimately, like, the market reach you guys can have? Where do you see this going? I think you're. Is this a billion-dollar product in your views? Yes, we believe it is. And I think, you know, look, pharma landscape, especially on the biotech marketing, has changed significantly over the past five years. I was... You know, I worked at Pfizer, where you had a 5,000-person sales force, and every single year, you saw that go down and down and down. And, you know, COVID certainly was the nail in the coffin on that one. The reach that you can get through these digital programs is significant, and it's effective, and using that to sort of amplify the voice that you see of a smaller but more targeted representative field force, that's how you can reach, you know, tens of thousands of physicians. I mentioned that's 40,000 physicians. That's 40,000 physicians this year. We'll continue to evolve that landscape and go after where we see the opportunity. Guidelines, I think, are another... Like you said, they're another way of getting the message out there, but, you know, we have a lot of different channels that we can reach out and get our message out there, and really be effective without necessarily having to go to the, you know, pharma mindset of 15 years ago with a 5,000 primary care sales force. Okay, and then a few months ago, you monetized your European royalties, you cleaned up the balance sheet. Walk us through the terms of that agreement, and why was that important? Cleanup is an understatement. So we had, I would say, a, you know, an overhang on the company of a, you know, senior royalty agreement, that, you know, we wanted to address, and we wanted to kind of get cleaned up, for lack of a better word. What we did was we monetized the European royalty stream with our partner, Daiichi Sankyo, for $305 million and negotiated an early discounted termination of our existing agreement. I wanna be very clear, this was not just a swap of one senior secured royalty deal for another. This, you know, in my mind, is how the new deal is how a royalty deal should be done. It's unsecured, there's no, you know, there's no security interest in the company, there's no recourse on it. It was a true royalty sale at a capped amount. So they, for $305 million, they will receive the royalty stream until they get back, I think it's $560 million, it's 1.7 times their investment, at which point the royalty stream will revert back to us, and that's one of the things that honestly got me most excited about it is, if you remember, as a part of the settlement that we had with Daiichi Sankyo, they are pursuing a triple combination in Europe, which not only puts a third product on the market for them but also gives them potentially 10 years of additional patent life in Europe. So this deal helped us to clean up the balance sheet now, but let us retain that upside and sort of, you know, triple combination benefit on the tail end when we see this reverting back to us, you know, sometime in the late part of this decade. Okay, and then ex-U.S., talk about the latest developments there, which we keep an eye on, Europe and then Japan as well. Yeah. So I mean, Europe continues to just execute flawlessly, is the best way to put it. They've shown fantastic growth since launch, and they expect to continue to do so. I think they've... At this point, they've launched all countries except for France in Europe, and that one, you know, is in process. Japan, they reported out their top line of the phase III bridging trial that they did. The results were great. We know that that's a population that bempedoic acid tends to do very well in, and the results absolutely reinforce that. They're on path to start that regulatory process, frankly, very soon. And I would also remind you and everyone in the room that there are a number of milestones related to that regulatory process that we will receive as that progresses from filing to approval to pricing, which are another tailwind of capital for this company. And then looking out into the competitive landscape, there are some things we should expect to see. Oral PCSK9s, I think we could see, some phase II data from Astra's, product. Merck has one in phase III development. There's an oral CETP inhibitor as well. How do you see that landscape evolving, and where does that leave NEXLETOL and NEXLIZET? We obviously keep an eye on all potential competitors in the future. I think the fact that there is now so much investment in the space and people trying to bring these assets online speaks to the opportunity and the value that this market can provide. I also very specifically in that primary prevention space, right? We're the first non-statin to be indicated for primary prevention, and if you'll note, all those competitors have now kind of piggybacked on that market space as well. You know, it's a huge market, so even as they come online, I think there's plenty of space for everybody. However, the oral PCSK9s are a long ways out. They have a long path to market, and, you know, from what we understand is we will be close to going generic by the time they have outcomes data, which I, having tried to launch a drug without outcomes data, I can say most people would not. You know, I know what I think there's some question marks as to that path to market, but at the end of the day, you know, I think if we wanna go back to Merck 616 and talk about that, they're doing a head-to-head trial against us, and I will say, do you do a head-to-head trial against the drug that you think is not going to be very prominent when you launch, or the one that you think is going to be the market leader? It's the latter of the two. So, you know, they're very clearly keeping an eye on us, and it frankly, we've, it's a little bit flattering. Outside of, I guess, longer term, how are you thinking about lifecycle management efforts, and can you remind us, what the IP looks like? Yeah ... for your current product? IP, I'll start with IP. IP, we have composition of matter with a pediatric extension till 2031, and, you know, we've tested this IP, it's strong and solid. We are planning the business at that point, and I am very confident we'll have no generic entries before then. We did have the ANDA process kick off earlier this year, and, you know, honestly, we've had some conversations today where people say, "What risk do you see coming from ANDA?" I don't see ANDA as a risk; I see it as an opportunity. That opportunity is we know we have patents that go till 2040. They're not the composition of matter, but they're, you know, method of use and formulation. And, you know, through the ANDA process, we can leverage those to potentially extend that 2031 farther. So we won't know that until we get into the litigation, which will likely be 2027, 2028. But it's an opportunity for this company. So yeah, I think that's, you know, we're in very good position from the IP space. As far as lifecycle management goes, you know, we look at that as Esperion is one company, but we also have Daiichi Sankyo and Otsuka, who are very much invested in this product. And we actually take a very collaborative approach across lifecycle management between the different companies. And, you know, we do. There are areas that we're looking at. There's nothing that we're gonna come out saying at this point, but we do have, you know, what I would say, standard lifecycle management strategies and trials that we're looking into that could give us, you know, continued runway. And then I think you recently talked about possibly hosting an R&D day next year. Yes. Any hints on what we could see? As a reminder for everyone, bempedoic acid is a first-in-class ATP citrate lyase inhibitor. And we have a pipeline which, you know, we don't get a chance to talk too much about 'cause we don't have the IP in place that we'd like in order to really give good, strong, messaging around it. We will likely have that in place soon, and in what we call our next-gen ATP citrate lyase inhibitor. You know, we'll talk more about this likely in the first half of next year and go into kind of what we're looking at from an indication standpoint and where we see the therapeutic potential of this next gen. To be frank, I'm very excited about it. I see this as something that's as valuable, if not more valuable, than bempedoic acid. I think there's a lot of potential within this pathway. Do you see the opportunity within CV or outside CV? Outside CV. It's, I'd say five years from now, if Esperion is still a standalone company, it- you will not think of it as a cardiovascular company. How do you think about resourcing your commercial priorities while building up that pipeline? I mean, a rising tide floats all boats, right? If we maximize the launch of bempedoic acid, that lets us then continue to add and increase the value of the company through reinvesting in the pipeline. I will say, up till now, and for the foreseeable future, that pipeline is relatively low cost. It's, you know, it's preclinical. The way that we're doing it is through leveraging big data AI models that can let us sort of come up with these predictive analytics on where we should look and how we should structure this. But even when it does come clinical, you know, the indications we're looking at are, you know, more rare disease focused, right? Small trials, quick path to market. and, you know, something that we can see that we will have ample resources to be able to fund and staff ourselves as we go through these trials. How much visibility do you expect to be able to provide on R&D Day? Are we gonna get- Yeah ... an idea of, like, the path, the development pathway? I would say stay tuned. Fair enough. I think we're getting close to the end of our time. Any last thoughts, and what should people keep an eye on? I mean, I think this is a company that is just poised on, you know, the precipice of really being an exciting company to work at, an exciting company to look at. You know, this has been a landmark year for accomplishments of the company, and I could not be prouder of everything that we have done from across the board, from a regulatory space, you know, from a commercial space and from, you know, not to pat myself on the back, but from a capital structure space. I think this is a very exciting company, and I am really looking forward to what the near future is going to bring. Okay, great. Ben, thanks for your time. Thanks for having me. Thanks, everyone.