Okay, good morning everybody. I'm Kristen Kloska, one of the bio analysts at Cantor. Thank you so much to the Esperion Therapeutics team for being here today. We have Sheldon Koenig, the CEO, and Ben Halladay, the CFO. Thanks again for being here. Thanks for having us. Good to be here. Thank you. Yeah, our first conference together. Yeah, that's right. Cool. Maybe to start, can you just provide a very high-level overview, and then we'll get into some of the specifics? Yeah, will do. First of all, again, thank you for having us at the conference and on behalf of all the employees, we're happy to be here and have the chance to chat. Thanks for all the attendees. Look, at Esperion, our mission is to essentially commercialize life-saving medications, which we're doing with NEXLIZET and NEXLETOL. We're also developing life-saving medications, what we think will be life-saving medications. We held an R&D day back in April 24th that you attended, and we have some interesting compounds. Right now, the focus is on commercializing in the U.S. You probably saw from our Q2 results, we have significant momentum showing double-digit growth in all metrics. We might get into this later, but we had a terrific European Society of Cardiology and the guidelines. Just really excited about the future and where we're heading. That was a very exciting way to kick off a holiday weekend in the U.S. Thank you to our partners in Europe for that. Before we touch into some of the drugs, I think it's really important to talk a little bit about patient background. I think sometimes this is overlooked, right? It's a critical part of the story. When we think about these patients, how are physicians monitoring cardiovascular measures in the real world? How do they then determine whether or not a patient is responding to a lipid-lowering therapy? Yeah, and I'll give you the real-world answer, not the academic answer, if you will. The real-world answer is there's a lot of what I would call fire and forget strategy with patients. Patient will go get a lipid panel, will show elevated cholesterol, and the physician will say, "I need to put you on a statin," and they put them on the statin, and they may or may not follow up. This is more in the primary care setting. I think cardiologists do more follow-up, but for primary care physicians, they really don't. I think, you know, what you heard in ESC, because I'll put this now, and I think where the world is going, it's about how do you treat stronger, faster. No longer can you get to goal on one product. A statin is not going to do it. Now it's about combination therapy, similar to where we've been with hypertension and diabetes for years. You know, a patient may come back after they get their lipid panel, and they might need some additional LDL-C lowering. Doctor may add ezetimibe, may not, may say, "Let's wait another six months." I think, you know, personally, that's why cardiovascular disease is the number one killer, not only in the world, you know, obviously not only in the United States, but in the world, is because it's just somewhat a laissez-faire of treatment. That's really unfortunate because you do have to treat fast, and that's a new emphasis. I know one of the ways companies report data is by this whole notion of LDL-C lowering in%. How do we account for the fact that patients are obviously coming in with different baseline measures and levels of degree of severity? Will the threshold of what really matters in the goals change depending on where they start off? I think, look, what's happening right now is patients are coming in, as I mentioned earlier, they're coming in with elevated LDL. There's this notion of they're X% away from goal, they're not at goal. You may recall in the U.S., back in, I think it was 2016, with the revision of the AHA guidelines, they got rid of goals. That caused a lot of confusion in the U.S. What you saw is physicians, especially cardiologists, look to Europe for what is a goal, and that became the 55 mg per dl. I think you're going to see that's going to be more and more is how do I get more aggressive with patients, especially at high risk, to get them to these lower goals of LDL. I went to a seminar at ESC. LDL cholesterol is what causes heart attacks and strokes. It's the buildup of that plaque. There are other drugs out there to address CV risk, et cetera. All of them working together are trying to provide more protection for a patient. You really have to get these physicians to realize they've got to get their patients to goal. Okay. Statins have been a great drug for several patients, but a lot of them don't tolerate it or they may not be responding. At what point are they going to their physician and saying, "Look, this isn't working for me. I need a new option"? How often is just changing a statin actually solving the problem? Yeah. Usually what happens is they present with some type of muscle ache or pain. Ben and I were actually just talking today, not to violate HIPAA, but you may want to tell your story about the rosuvastatin. Yeah, I'm on rosuvastatin and I've recently started feeling muscle pains. I'm on the lowest dose of rosuvastatin, 10 mg. Sheldon and I were talking earlier today, is this statin intolerance, essentially? The same thing happened to me when I was originally put on atorvastatin. I'm a big runner, or at least used to be, and I'd get this leg pain. My doctor was saying, "Let's try you on a different statin at a lower dose." That did help, but because it was just a low-dose statin, I couldn't get to goal. I think, as you know, I take and my cholesterol is at 40 mg per dl. I'm really excited about that. I think the point is that patients will come to their physicians and say, "I cannot take a statin." I think what happens there is they consider, "I could try another statin, or I can also just maybe even use a drug like," which we're seeing a lot of momentum with. I think one thing to keep in mind is LDL-C is an asymptomatic disease, right? You don't feel bad when your cholesterol is high. Exactly. For 30% of the U.S. population or the global population, by taking something and addressing your LDL-C, you're turning that asymptomatic into a symptomatic disease through muscle pains or myalgia, a lot of the different side effects of statins. That's where I think there's a real opportunity for additional therapies to come in and help get those people to goal. Yes, interesting, right? When you have a condition where technically you feel fine, but all of a sudden you're getting on a medicine and you don't feel fine. Even though you understand the importance of your heart health, it's a change for you, right? Exactly. Okay, I guess just to help us understand though, at what point do physicians say, "Okay, look, we tried you on another statin, we tried messing with the dosage, now is really time for me to maybe offer a new drug that has a different mechanism of action for you"? It happens pretty quickly. We're seeing that now. You know, we pivoted to a strategy to really establish this beachhead of going after statin-intolerant patients. That's two types of patients: patients who, one, can't take a statin at all, and there's a lot of them. We know the NLA put out the paper in February, said 30% of the patients can't take a statin at all. Then there's those patients who can only take a low-dose statin. What's interesting, again, just to go back to the ESC guidelines and even our own data that we've shown, is that with a low-dose statin, and the SANTORINI study showed this as well by Daiichi Sankyo, a low-dose statin plus gets close to 75% of patients to goal. That's the beauty about and NEXLETOL. You can use it with a statin or without a statin. I think that's really important. Physicians have really picked up on that. Okay. To the point earlier, part of this is like a lot of education because you're telling the patients they're at high risk, but again, they don't necessarily feel the aspects of their disease every day. What does it take for, like, do you, is it your understanding that these patients actually take that feedback quite seriously and they will do whatever it takes if it means protecting their heart health, avoiding events? If patients are educated appropriately, they will. Okay. Especially if they have family history. Yeah. It's something that motivates them. I'll just put in a quick commercial. We have a commercial that's going to be starting in about 20 days on Connected TV, directed to consumers. We're excited about it, especially any of you Grey's Anatomy fans. It'll be running during the new season. That is going to also motivate consumers. Okay. I am admittedly a Grey's Anatomy fan, so I look forward to seeing the commercials along with the, I don't know, 10+ million people that are also still sticking with it after 20 seasons like me. One source of pushback has been that statins are generic. How does this play into the whole reimbursement dynamic? Yeah, it hasn't been an issue. You know, statins are always considered the cornerstone of therapy. Yeah. If you look at our coverage, we have 92% favorable commercial coverage. If you look at Medicare, we're at 75%, again, preferred favorable coverage. The copay is affordable. There's actually a really interesting paper that just came out in Circulation about a month ago. I'm not sure if we sent it to you, but I will. It basically shows what drives consumer preferences. What drives is price and also convenience of dosing and hopefully an oral. We meet all of that criteria. Not only do we have this great reimbursement environment, we're oral, so you don't need to inject, and it's easy. It's once a day, with or without food. Okay. Let's shift to some of the market initiatives now. Maybe just what's been your high-level strategy? You mentioned on your last earnings this was a big inflection point in our view at least. What's kind of been leading to that traction? Yeah, I think what's been leading to it is, again, we've been really out there messaging to physicians, you know, similar to the questions that you asked, is that we know you've got patients in your waiting room who can't take a statin or are not at goal because they can only take, you know, a partial dose of a statin. Why wouldn't you add Nexlizet to them? You have 38% additional LDL-C efficacy. That has really resonated with physicians. The other thing is, as you know, from the Clear Outcomes Study, we have a very unique indication from a primary prevention perspective. We're the only ones who've studied a drug like this in statin-intolerant patients. It's a message that we can own. That's really resonating with physicians. What we're seeing is they're saying, "Hey, if this, if this is the efficacy I get without a statin, what would it be if I added a statin?" We're seeing more of that as well as we move across our segmentation. Okay. We often talk about the U.S. opportunity, but I think, of my entire coverage universe, maybe even you've been very smart to leverage successful partnerships in regions where they already have expertise. You've been very clear, like, let the experts in those territories, they will have the best chance of getting our drug out there. Just before we jump into all of those, obviously each country's a different size, but just like from a prevalence standpoint, is it similar to the U.S. or are there regions where it's lower, higher? Yeah, so I think kind of going from top of the list down to bottom, Europe, they've demonstrated fantastic traction for this drug. The guidelines only reinforce that. I think, you know, I've had people tell me this will now just sell itself in Europe. That's been the biggest. We think, honestly, there's a good chance this could be one-to-one U.S. to Europe and a billion-dollar product in both markets. I think after that, Japan is by far the biggest market. We think that's a third, and it's a close third to Europe. There's a lot of opportunity. We know that statin intolerance is very prevalent in the Japanese population. You also tend to see more super responses in that. The trial that Otsuka did to bridge that clearly defined that. After that, we also have partnerships in Canada, Australia, Israel. I think those are, they're smaller markets, but I think there's still a lot of opportunity there. They've made, we recently had some very good progress on the regulatory process. They're moving those forward. It's all incremental, right? Especially in Canada. It's a very tough reimbursement market in Canada to get, you know, any sort of favorable access there. What they've managed to do has just been incredible. I think we will have a very good outcome from those launches that'll put meaningful top line to this company. On that note, do you mind sharing what these new guidelines are? I'm not sure if everybody's aware as it's quite frankly hot off the press. Yeah, sure. We actually received a Class 1A recommendation, which is really the best you can get. I think what was important is that bempedoic acid was the only new therapy that actually received its own section in the guidelines. The focus was really on, again, you know, how do you strike fast, strike quickly? I think what was important about the guidelines and during the review of bempedoic acid itself, during the guidelines, I was there live, was the fact that these changes were made based upon data that was practice changing and essentially life-saving. That's really important, and it's something that, as you know, we mentioned in our press release. It essentially demonstrates that bempedoic acid is a foundational therapy in treating patients. As I said earlier, one drug doesn't get you to goal. In every combination they showed, it was with bempedoic acid first, and then if you needed more, to add more. I'll say it again, the study showed that patients who are on a statin or on bempedoic acid, 75% of them achieve goal. There's room for other drugs, but for the majority of purposes, bempedoic acid is your partner of choice. Okay. When we think about all these other geographies where you have existing partnerships, I know all of them are structured differently in terms of milestones and royalties, but what is the collective TAM or opportunity, and how is this going to keep the engine going for the U.S.? Yeah, I mean, I think, like I said before, I think Europe is definitely a billion-dollar opportunity. I think, you know, from a TAM perspective, we, you know, 30% of the population is statin intolerant. We think that there is a lot of opportunity to address that globally. We think that's consistent across all markets. The royalty streams are pretty consistent between each of the agreements, and that's just incremental top line to us addressing that 30% statin intolerance. It's a pretty significant tailwind for the company that we expect over the years. Overall, I think just from a collective TAM perspective, again, in the U.S., it's $70 million. Europe looks a lot like the U.S. This is one of the largest markets, one of the largest therapeutic markets in the world. No question about that. You're also working on a triple oral combination, which may have been even more competitive to what we're seeing out there. How do you already, though, have a strong sense of what the combined LDL-C reduction could look like? Yeah, we've actually modeled that. You know, we actually conducted a study, and we looked at the use of atorvastatin 10 mg with bempedoic acid plus ezetimibe. We showed anywhere between 65% and 72% LDL-C reduction. I would direct you to the ESC guidelines where they've done their own modeling, and they're showing 65%+ LDL-C lowering using a triple combination. We are doing a triple combination in both rosuvastatin and atorvastatin, so physicians will have a choice. I'm going to brag for the company and Daiichi Sankyo. We had the strategic foresight to see that combination therapy was going to be the future of therapy in cardiovascular medicine. When it came to lipids at ESC, that was the focus: combination therapies. Now, not only do you have this powerful LDL-C lowering drug, but it's a one pill. It's convenient. It just makes perfect sense. We're ahead of the game, and I'm excited about it. I will say we already have names for these drugs. We're not releasing them yet, but stay tuned because they're really good ones. Does it start with an N? No, it doesn't. We can go through the alphabet if you want and try and guess that. Let's see, we got to a milking it. If this ultimately does become approved, how is it going to change the treatment paradigm, including a good way to be competitive with your other two existing therapies? I think, one, it gives physicians flexibility, but regardless of if you're using the triple combination drug or if you want to be old fashioned and, you know, use whatever combination you want, use drugs individually, et cetera, it's all about getting patients to goal faster. That's the theme here. How do I get patients to goal quicker? I think everyone thinks of atherosclerosis as this kind of, you know, oh, I can live with it for years. I don't have to worry about it. That's not true. Not to scare anybody, but plaque could break off, you know, right now. You could have a stroke or a heart attack. There's no such thing as it's going to take its time. It's a disease that, unfortunately, because it's quiet, you think you have time, but you may not. That's why you have to treat aggressively. That's what triple combination drug or any combination therapy with our drug will allow you to do. Okay. On the competitive side, why don't you believe investors should be super hyper-focused about this? You know, one would think even if they are successful, you're not competing over 10,000 patients worldwide. There should be plenty of room for others, right? Yeah, there's definitely room for others. Again, you know, unfortunately, this is a disease that's the number one killer in the world. We've got statins, we have PCSK9, we have bempedoic acid, you have bile sequestrant, cholestyramine, old drugs. We have all these drugs, right? The fact is, again, it's a combination of the use. I would argue, of course, you would use NEXLIZET first, is what the guidelines showed in Europe, and we'll see what the U.S. will show. These other drugs, they're not on the market yet. You know, when somebody asks me, how do you compete against a Merck or a CTP, I would say, what do their labels look like? Because, you know, we have an outcome study. Yeah. We have to wait and see where these drugs end up. In the meantime, we're available now, soon almost across the entire world. Yeah. Sorry, I should have asked you before these guidelines that come out, how do physicians actually react to them, abide by them? Like, how important are they? They're super important. Especially with cardiologists, Cardiologists really focus on the guidelines and what you find, at least in the United States. In Europe, they're very important. Everyone looks at them. In the U.S., it's usually really looked at by cardiologists and then through advocacy and talking to primary care physicians, the message gets carried through. If you look at Entresto back in 2016, when they finally were allowed to be put into the guidelines, they were to be used as the primary antiplatelet after hospital discharge, the drug really took off. It wasn't until then. We've been able to show this momentum and all the payer coverage I talked to you about before we even have guidelines. Now with these guidelines, it's just really a reinforcement, if not even more of a catalyst to say, I should be using this more, again, depending upon what the U.S. guidelines will say. We feel, as we felt with the ESC, that we will be prominent in the U.S. guidelines. Do we have a sense of when the U.S. guidelines might come out, and just historically, do we tend to see similarities? Do they kind of leverage off of each other depending on which one gets updated first? They used to, back in 2014 or 2016, when the changes were, they diverted away, as I mentioned earlier, with no goals. Yeah. I think what you'll see now is there'll be more of an alignment because there was such controversy over the last time the guidelines were done. Sure. Late breaking news, we think the guidelines will be available early first quarter before ACC. The reason for that is that ACC, that meeting, will be used as a training ground for the new guidelines. Okay. That's the latest information that we have that's new, and we'll be following that. Cool. You heard it here first. Yeah, that's right. You did have an R&D day this year and we learned about the next indication that you're looking at, primary sclerosing cholangitis or PSC for short. Unfortunately, it has been an area where we haven't seen much success. What are the key things we can learn from others that have tried and failed, and what is it about this target that may make sense? Yeah, I'm not the expert in the science, but I think the way that, you know, it's been described to me and from, you know, what I've seen that Steve Pankowski has been working on this is we have kind of found this intersection between cell metabolism and fibrosis, where, you know, we can not only go after the injury, but we can also provide healing itself. No other compound that's been developed or being developed has been able to show that. This is really due to ACLY biology. This is what really makes this pathway unique. That's why, you know, we feel so, I would say, confident that we're going to have success. We hope to be in the clinic next year. That's our goal. You know, we're excited about this and, you know, stay tuned. We'll be providing more of an update as we get into early next year as well where we are. Is there a sense of when in the disease course it might be best to try to treat these patients? I think, from what I understand about the disease, it's somewhat late. It's almost a late presenting disease because it's not easy to diagnose. I think it's right at diagnosis you'd want to start this type of therapy. Yeah, I know at your R&D day you had a mother kind of walking us through her son's experience and how he was diagnosed. Right. Also, often because this drug or this disease leads to transplantation. Yeah. The sooner you can do something to maybe either delay that or not have that at all, I think it would be important. Okay. What's the current financial situation of the company, and anything else we should really be taking away today about Esperion? Yeah, I think the current financial situation is great, to be honest. I'm trying to come up with a better word to say it, but it's great. We've done a lot of work over the last two years correcting the capital structure of this company. That demonstrated trajectory has really continued to improve the financial profile of not only where we're going, but also where we are. In Q2, we announced we had positive operating income for the first time from ongoing operations, not necessarily driven by a large milestone or a one-time event, but just the things that we do every single day drove positive operating income. We've gone on record that Q1 2026, we believe, will be our first fully profitable quarter. Candidly, I don't think anyone believed us until Q2, and that now lets people draw a direct line from Q2 to Q1. We've decreased the debt profile. We have ample cash. We've shown strong U.S. growth that has continued quarter over quarter over quarter. We don't see that changing anytime soon, to be honest, up until loss of exclusivity, to be honest. Yeah, it's good. If I may ask a question, can you provide clarity around the Otsuka milestones? Yeah, no, thank you, Sheldon. I was supposed to mention that earlier. The other thing to keep in mind is I said we have ample cash now, but we also have large milestones with our Japanese partner, Otsuka, and those are tied to the regulatory process in Japan. To be very clear, they are tied to both approval and pricing. We had a preliminary approval on it from the Health Authority last week. That's not the official approval, but it's one of those things that I don't think there's ever been a breakup between the two ever. It's kind of a tentative approval. Pricing can't happen until that full official approval happens, but it usually happens shortly after. We've already had some of those pricing discussions. We need both of those to achieve those milestones, but we're confident that those events will happen in the near future. I think what we saw Friday was not that we ever thought that there was any risk, just a de-risking to the approval. Very important milestone. Wow, you had a great Friday. Yeah, it's been complete. Awesome. Thank you so much for being here. Really appreciate it. We're excited to see what you have in the next few months ahead. Awesome. Thank you so much. Really appreciate it. All right.