Thank you, everybody, for joining us this afternoon at the Citizens JMP Life Sciences Conference. Excited to be joined next by Esperion Therapeutics. Esperion has a commercial franchise focused on LDL medicine, two products, NEXLIZET, NEXLETOL, products both approved in Europe as well. I won't repeat the brand names there. Happy to be joined by Sheldon Koenig, CEO, and Ben Halladay, CFO. Let me start off by just saying congrats. It's been a super exciting year. You got the label expansions approved in the U.S. that adds the really positive cardiovascular outcomes data from the CLEAR Outcomes trial. Those approvals are expected in Europe now as well. We already have the positive CHMP opinion. So congrats on that. And maybe with that, I'll just ask to give a quick intro of the company and the core focus for this year. Yeah, great. Well, thank you again. And on behalf of Esperion and all the employees, as you know, Jason, great to be here for the Citizens JMP Conference. As you mentioned, joined with Ben. Just for the record, it's Nustendi, which is bempedoic acid plus ezetimibe and Nilemdo in Europe, which is bempedoic acid on its own. And to your point, we expect approval any day now, so any day. So really excited about that. The focus of the company, as you mentioned, the background of the company is since we've gotten these new labels based upon our CLEAR Outcomes, we're out there executing every single day. And as we've made aware, just even coming out of first quarter earnings, which was a very successful quarter for us, we showed growth from fourth quarter to first quarter. We showed 6% growth in total prescriptions. We showed 11% growth in NRXs, new, and 15% growth in NBRX. That's without even the new label. With the new label now, we're out there with 150 representatives marketing to both primary care and cardiologists. We are really pleased in the growth we've seen thus far with really being out there for three weeks since we've had our launch meeting. So obviously, I want to spend most of the time talking about the future and with the new labels. But maybe just as a backdrop, can you talk to us about the first few years, the launch, where you'd gotten to with the franchise in the U.S. specifically, and just the kind of patient profile that you were treating based on the label? Yeah. And just to remind everybody, and we've obviously had one-on-ones all day today, this is really a turnaround story, Esperion Therapeutics. And just to be honest, with people, why should I believe? Well, the reason why I should believe goes all the way back to October of 2021, when we said we would demonstrate consistent growth, that we were going to really focus on our cap structure and our spend, and we were really going to focus on getting to the CLEAR Outcomes study, because that's the true inflection point for these products. Why? Because the original label, which was launched all the way back in March of 2020, not a great time to launch during COVID, et cetera, it was very narrow, very restrictive. It was only for those patients who had documented ASCVD. Payers would always challenge us and say, hey, you don't have outcomes, so we're going to further restrict you. So we could only focus on a patient pool of about 10 million. And 10 million might seem like a lot, but that's even more restricted when physicians have a hard time getting it because of barriers associated with no outcomes. The new label expands that patient population to 70 million patients. And the drug now can be used for those patients who are on a statin and not to goal, obviously for the ASCVD or secondary prevention patient, but primary prevention. And that's a huge differentiation for us. That's something that only statins have shown, the fact that they can be used in primary prevention patients. After statins, we are the only ones that can show that. PCSK9 cannot show that. Ezetimibe, which is the probably most widely used drug after a statin, cannot show that. So it allows us to go after those primary prevention patients, secondary prevention patients. That's a pool of over 70 million potential patients. So pretty significant increase in potential patients. Great. So let's talk about the CLEAR Outcomes data for a second. So you hit the primary endpoint, obviously. But I think really importantly, you hit several of those key secondary endpoints, like reducing myocardial infarction. Can you just give us an overview of the key takeaways from the trial? Sure. So the CLEAR Outcomes study was a study of over 14,000 patients. Steven Nissen was the primary investigator. It was presented at ACC 2023. I think it was April 5th, if I remember correctly. It was very early in April. And what the study showed is that we reduced fatal and non-fatal MI by almost 25%. Very significant. We reduced the need of revascularization by 19%. We reduced LDL cholesterol with NEXLETOL alone at 22%. And again, be reminded, this was a study looking at NEXLETOL only, so not or bempedoic acid. Furthermore, we showed that at the six-month measuring point, we reduced hsCRP, a critical measure of inflammation. And that is very important because, again, only drug other than us that can do that is a statin. PCSK9 cannot reduce inflammation. Zetia could not reduce inflammation. One other key point is we showed that we had no effect on glucose. That's very important because, as many of you know, taking a statin will sometimes push you from prediabetic, make you prediabetic, and put you into diabetes. All of those together, those elements really showed how this drug is differentiated from current therapies that are out there. But the beauty of bempedoic acid is we work in the same pathway as a statin. But because we're not absorbed in the smooth muscle, you don't have the muscle aches, the myalgia, et cetera. That's just another element of why you can use this with a statin, or you can use it on its own if you can't take a statin. Those are the key takeaways. It's been very well received here in the United States. I'll chime in a little bit too. One of the things that got me excited about the CLEAR Outcomes trial is even in the months afterwards, you saw subsequent publications talking about some of the smaller populations within the trial. Sheldon mentioned the primary prevention population, where we saw cardiovascular benefits, up to 40% reduction of events. We had to continue talking about the diabetic population within the trial, where we saw some significant benefits for a very at-risk population of patients. There's just been a constant stream of exciting publications post-ACC last year. We saw immediately after ACC, there was an inflection in adoption, right? That was without the labels, without additional promotion. The data resonated with physicians. Absolutely. That helps Lester Holt talking about your drug on Nightly News. Yeah. Can we just talk fast forward? So now you have the labels approved. Just walk us through. You gave us a couple of numbers. But just walk us through the actual indications, what you're approved to treat now. Sure, absolutely. So we are approved to go after both primary and secondary prevention. So primary prevention, easily defined, are patients at high risk who have not had an event yet. So I'm a great example. I'm on NEXLIZET. I take rosuvastatin 10 mg, and I take NEXLIZET. I have not had an event. I hopefully won't have an event. But it's for that patient who has not had an event. So it's always like, think about that, that we can prevent an event before it happens in a disease area that is the number one killer in the world. Secondary prevention, these are patients who have already had an event. How do we prevent them from having another event? And to Ben's point, at ESC last year, we actually did an analysis that showed that NEXLIZET significantly reduced those patients who had multiple events from having another event. That's who we're going after. We're targeting to both primary care physicians and cardiologists. It's a total target audience of about 20,000 physicians, both with personal promotion and also digital. We mentioned ACC. I just want to mention, it wasn't only physicians that saw that, but it was consumers. A lot of consumers went to physicians. We've launched a new consumer campaign called the Lipid Lurkers. You'll see them. They're taking over our Facebook page, our Instagram page. But it's really to bring awareness to consumers that, hey, I need to make sure I'm managing my cholesterol, et cetera. It's early days, but we believe so far that's showing to be quite effective. One part of the approval process was you gated the investment in the commercial infrastructure to the label expansion. Can you just talk us through now what you've added over the last couple of months? Yeah. So we've added about 72 representatives, which has gotten us to we have 150 representatives out there in the field. In key areas, we have someone who overlaps almost the key account manager. We have 5 of those in some more denser populations. So we added those folks. As I mentioned, we added the digital aspect, both to physicians and for consumers. These were all minimal spends. And for us, we're at a spend of where we need to be. We don't need to increase it, et cetera. So it's very stable. And we had prepared for this. To your point, we made sure our representatives were hired by early January, put them through training. We had an all-company meeting that we just came from, knowing when we were getting the label, trained them all there. As I mentioned, they've really been out in the field for the past three weeks, using their new detail aid, et cetera. So walk us through that. What is the message now to physicians? When a physician says, I have statins, I have multiple statins, I have Zetia, they're probably not going to talk too much about PCSK9s. But what is the core message for the franchise? Well, the core message is, after a statin, we should be used next. We're the next drug. And if a patient cannot take a statin, then you could also use us as well. But the message itself, if I had the detail aid in front of me, I would walk them through exactly what I talked to you about as related to the reduction of MI, the reduction of fatal and non-fatal MI, the 19% reduction in revascularization. I would show them NEXLETOL. But then I would show them NEXLIZET. And the key message is, if NEXLETOL could get these results, let me show you what NEXLIZET could do with a 38% reduction of LDL versus 22% reduction. That's the key message, combined with a payer message. And as we mentioned in our prepared remarks, we've already seen payers making changes in their criteria to align with our label. There'll be 50 million lives that will be aligned to our new label effective June the 1st. We have about 9 million aligned right now. An additional 41 will come on June the 1st. So I want to come back to the payer piece in a second. But just with the health care provider themselves, other than access, I got to get it reimbursed, what are the hurdles or the challenges that they need to get through to understand that message? Yeah. So I think for them to understand that message and first of all, one thing also that I failed to represent is there are certain patient types that we're showing them, right? We're showing them the diabetic patient. We're showing them the patient who can't get to goal, et cetera, the patient who's had multiple events. To get them there, which we've come a long way, we mentioned ACC. We had zero awareness. ACC 2023, we had overnight awareness. And so now it's just the appreciation of that mechanism of action and what these drugs do to get them there. And it's really just showing them the data, honestly, to show them that your patients are going to get to goal with this drug. But more importantly, you're really going to manage their risk of an event based upon the CLEAR Outcomes data. The population of that CLEAR Outcomes study was so diverse. You had a majority of patients who are diabetic. So these were sick patients. 50% of the population was women. 18% was Latin America. It was Latin America. And this was one of the more diverse studies. It doesn't necessarily answer your question. But I just wanted to fill that in there, that these are other messages that you can supplement with a message to get them to prescribe. And just one other fact is to show them that there's no effect on glucose, as I mentioned earlier. Not to jump all over the place. No, no. It's really helpful. There's so much data. Yeah. So going back to that payer piece, you said you've already had some early wins on expanding coverage to the new labels. Walk us through the timelines to get to full broad access. And have you seen any challenges today? Have you had any pushback? Or is it just a case of going through the process and educating the different providers on the new labels? Yeah. So payers, we got a head start last year after ACC. We went to them right away. We had a small change in our label in December, which was another way to go back to them to say, hey, our new label, this is nothing. Wait till you see the new label. And quite frankly, it was a show-me story. It was, well, we want to see the new label. And we did. And we've seen these changes. One of the changes is one of the largest Medicare providers. Usually, when they make a decision this year, it's not effective until next year. But not in this case. It's effective June 1st. And we've had no pushback from our payers. We have not needed to give any concessions because I think our contracts were always a bit aggressive from the beginning. So from a payer perspective, we've been quite satisfied. The team has done a great job getting us to where we need to be. I think by the end of the year, we actually mentioned our prepared remarks in the first quarter that on a weekly basis, we'll continue to get wins with downstream accounts, et cetera. In the meantime, we have a way to help patients get this drug until those criteria are put into place. We're using a specialty pharmacy called ASPN. And even if you look last week, we had an 80% increase in prescriptions going through that, the highest number we've ever seen, which goes to show that, one, representatives are getting the message out there. Physicians are using their eRx capability to prescribe this drug. And Eric, our Chief Commercial Officer who's in the audience, he has weekly meetings with the sales force, et cetera. We are not surprisingly hearing any major pushback, complaint, et cetera. If anything, it's more about this data is stellar. This is great data. If there's anything that. Nothing to add. Missing. Obviously, part of this question is focused on sales reps, targeting, et cetera. But thinking more broadly about the whole marketing package, the digital tools, et cetera, how are you going to gauge over the next couple of months, quarters, where you should be spending more time or spending more money really driving growth? Yeah. We do return on investment analysis on all of the assets that we're using now, for lack of better words. It's what led us to the strategy in the way that we've created this mix of X amount, 150 people for personal promotion, X amount for digital, X amount for consumer. We'll continue to do that on a routine basis. We've mentioned on one-on-ones today, we come from a background where we've launched multiple products. We've dealt with launching outcome studies. And this is the way you do it. There is an algorithm to know how to deploy and spend money. And we've got this guy to the right of me that makes sure that, hey, we're making the investments in the right place, et cetera. So we have a team that looks on that, pretty regular cadence, I would say. Yeah. I will say we've always very diligently assessed projects as they come in and invested money in a way that we know will generate not just a return, but an immediate return. We've said no to a lot of things that didn't meet that criteria. We'll continue to do that forever, as long as I'm CFO, for sure. That's how we've approached everything we've done with this launch. Maybe a nice time to take a tangent and just talk about how you feel about capital resources today, Ben. What are the overall capital structure? How well resourced do you think you are to execute on this project? Yeah. I think we're in very good shape. I think coming into this year, maybe not the case. But in the last just quarter, we've turned things around dramatically. We have the money we need to fund the launch and really start showing that incremental growth here and to be able to invest in those initiatives that we think will generate that return. I think we have plenty of cash. At the same time, we do have a capital structure that needs to be cleaned up. And I would say we're actively working on that because I think that's one of the last kind of capital overhangs of this company now. But I think we're in very good shape. And ultimately, executing on all those things makes the rest a lot easier. Maybe shift to the international markets. Obviously, you have a strong partner in Europe. Can you maybe just talk to the traction that the products have gotten in Europe? Yeah. So in Europe, Daiichi Sankyo Europe has done just an amazing job. They've shown double-digit growth every single quarter with this drug. And when I say double-digit, it's not 10% or 15% or 18%. It's 26%, 28%. And that also equates to just number of patients. And part of that is because they had a head start. They were basically matching this drug with a DOAC that they sell. They had HTA approval in these countries. And so they had a very nice transition from that to Nustendi and Nilemdo. The outcome study is only going to help them even more. There's no need for them to go back to HTA authorities. And every country they've launched in has been a hockey stick. I mean, even the UK., which is a really tough market, they've done very nicely. And that's not a dig at NICE, the HTA. But they have. And they're a great partner. I think there's always a question of, oh, you went through a lawsuit with these guys. But we just came from Munich. We were there. We met with them. And that was being battled at a different level. These folks are very much engaged in the business. This is what they've done. This is what they do. It's the only part of the business focused on cardiovascular medicine. The rest of them, it's more oncology. And it was interesting while we were in Munich, what we found out because we're doing the tech transfer manufacturing is that Daiichi Sankyo Europe now considers these brands as a global brand. That's a big deal for them. They see the importance of what it means for them. And so that's reassuring to us, too, as the tech transfer continues also. Where are they in terms of country-by-country launches? Are there more countries that you expect them to move into in the coming years? Yeah. So for the most part, the major countries, if you will, in Europe I always want to say the big five. But it's without Canada, ex-Canada, which is a country we're going to file in, Esperion. They're moving quite well. France is a market that's targeted, I think, for later next year. It's a little more difficult in France. You have to go through the French Transparency Commission, not as easy. But it's a big market. And they have plans. They also have plans to move into Eastern European markets. They're doing very well in the Asia regions where they're marketing the drug. So doing well. And I don't know if you're going to ask us about our other international partner. Otsuka. Yep. Yep. Thank you. So I want to make sure, so Otsuka should be finishing their phase III trial very soon. And when I'm done speaking, I'll have Ben maybe talk about how the breakout is of the milestones. But very good partnership with Otsuka. Japan is a very big market as well. So we're waiting and watching them as they go through phase III. And we will get some milestones as it relates to that. Yeah. Very exciting because I think going back to one of your early questions about capital resources, in the very near future, we will also have these milestones from Otsuka coming into play, which are associated with filing in Japan, approval in Japan. There's a pricing milestone. And so all of these will start coming. They're not similar to some of the Daiichi ones, which were large and infrequent, but instead are going to be a little bit smaller but a lot more frequent over the course of that regulatory pathway. And we expect those to come, I would say, in the next 18 months. Got it. We've seen recent disclosures about ANDA filers and you guys, not surprisingly, filing suit against those filers. It's a, I don't want to minimize this, but normal part of the business, right? It's something you expected. Can you just run us through the Orange Book listed patents that you have? And I know it's an obvious and easy question to answer. But how stringently will you defend your IP? If you've talked to me the last 2 weeks, I always say I got to get my ANDA plug in. So if you look at the ANDA filings that came out a couple of weeks ago, it was Pfizer, Merck, J&J, and us. And so you can see no one's immune to this, no matter how big they are. I think just most biotechs either get bought or go bankrupt before they reach this point. So with the ANDA process, we have composition of matter. Let me preface this. It's not in the Orange Book yet. But we have received a letter confirming that it will be. It gets us to 2030. And then we have a pediatric extension to get us to 2031. So that is solid, well-vetted, strong IP. But I would also remind, we have formulation patents that go to 2040. So there is ample room to, through this ANDA process, potentially maneuver and be in an even better place than we came into it. I'll caveat that with, we're not going to know that for a very long time. These are 5-year litigation processes that are very closed. So there won't be a lot of information. And it'll be a while till we know that. But there is opportunity there. Got it. Sheldon, I just want to just come back to one point you highlighted before. And that's where the drug's used in terms of patients who can't take a statin versus patients who can take a statin but not enough of a statin. So can you just walk us through that dynamic and how that really dials into the addressable market here? Sure. And this story goes back even to the introduction of statins in the early '90s. There's multiple doses of statins. Let's start with the patient that can take a statin first. It's well-studied and well-established that if I just keep moving you along the continuum of, say, atorvastatin, I move you from 10%-20%, 20%-40%, 40%-80%, not only are you probably accumulating more adverse events, but you're also only getting a 6% additional LDL increase. So it's just not effective. It doesn't benefit the patient. Most patients are that. One, they're not even titrated. We know the majority of patients are not at goal, which is leaving them at risk for having an event. And that's where you have the benefit of adding a drug like NEXLIZET. After statins, the most widely used drug are not PCSK9s. It's ezetimibe. And what is NEXLIZET? It's ezetimibe plus bempedoic acid, which gives you significant LDL lowering, as I mentioned, 38%. We've seen it more. Now, there's the patient who can't take a statin. They've tried a statin. They have muscle pain. Or they just won't do it. They're afraid that there used to be a rumor that, oh, you have Alzheimer's. Or my glucose is going to go it's just a I don't want it. They can take a drug that, as I mentioned earlier, works in the same pathway of a statin, not have that muscle pain, et cetera, and give them protection that they would not normally have. And our new label allows them to do that. That's a pure statin intolerance. But statin intolerances, you can't take a statin. I know we're out of time. Or you can only take a certain dose of a statin. Let me just make sure that there's no questions in the room before we close it out. All right. Sheldon, Ben, really appreciate you being here. Thank you. Yeah. Thank you so much. Thank you.