Hello, everyone. Welcome to our next Fireside Chat. My name is Lander. I'm a Senior Research Associate at H.C. Wainwright & Co., and here with me is Sheldon Koenig, President and CEO of Esperion Therapeutics. Hi, Sheldon. Thanks for joining us. Hi. Great Great to be here. Thank you. Of course. So before we start, from a disclosure standpoint, we currently cover Esperion with a Buy rating. So maybe, Sheldon, for those who may not be familiar with Esperion, can you provide a general overview of the company? We'll go into details next. Yeah, sure. We only have 19 minutes or so, so I'll make it brief. But at Esperion, we are developing and we are currently commercializing life-saving products. The products we're commercializing right now are NEXLIZET, which is bempedoic acid plus ezetimibe, and NEXLETOL, which is bempedoic acid on itself. And on April 24 of this year, we actually had our R&D Day where we announced the development of a lead compound for PSC, primary sclerosing cholangitis, which is a very rare orphan liver disease, which I think we'll talk about later. So great things going on and a real pleasure to be here. Thank you. Awesome. That's very helpful. Let me start with your commercial asset, with bempedoic acid, which is currently approved as a lipid-lowering agent in 40 countries globally and also for cardiovascular risk reduction in the U.S. and in Europe. Can you provide a quick snapshot of the target population and also tell us how bempedoic acid differentiates itself from other approved or investigational LDL cholesterol-lowering drugs? Yeah, absolutely, so I'm going to start with the indication that we actually received back in April of 2024. That was based upon the CLEAR Outcomes study where we studied 14,000 patients, one of the first studies to ever actually look at a statin-intolerant population, and we received two very important indications out of that study. One for secondary prevention, so if someone had a heart attack, et cetera, we can show that we can reduce their onset of a fatal/non-fatal MI by approximately 25%, and we can reduce revascularization, which is a stent, et cetera, by 19%. We also received an indication in primary prevention, which shows that we can essentially your risk of having an event for the first time greater than 35%, almost 40%. Matter of fact, we're the only drug, we're the only, if you will, oral non-statin that has studied or oral lipid-lowering agent that has studied a patient population, as I mentioned, statin intolerance, to have that indication. And it's resonating very, very well. Not only in the U.S., where we continue to show double-digit growth on all metrics that we report on, but also our counterpart in Europe, Daiichi Sankyo Europe, has also shown double-digit growth. As a matter of fact, last quarter, they showed about a 30% increase in the prescribing of the drug. I think we might get into guidelines a little bit later, but if not, I'll put in a commercial as what's happening in Europe and what will be happening in the United States. Awesome. Yeah, so going back into the guidelines since approval, can you share how bempedoic acid is being adopted by treatment guidelines and also by actual prescribers in the real world? Sure. So in the United States, prescribers, currently what you're seeing is about 60% of the writers are primary care physicians, 40% are cardiologists. And if you use a drug, Zetia, which was an old Merck drug, which is now ezetimibe, which bempedoic acid plus ezetimibe, if you looked at prescribing habits, that's the same type of writing that you would see. We're seeing a lot of pickup of the primary prevention and the use because of primary prevention, because of primary care physicians. I think one other thing to note in the United States is that we also are using a strategy of statin intolerance. So if you're somebody who can't take a statin at all, which 30% of the population cannot, you can use NEXLIZET. If you can take a low-dose statin and you need more LDL lowering, you can take NEXLIZET. I say that because it's a good segue into what was presented two weeks ago at European Society of Cardiology, where a new review of the guidelines were presented, and what they stated was that no longer can you get to goal with just a statin alone or any one drug alone. You need to use combination therapy similar to hypertension and also diabetes where you use multiple agents, so just as a quick recap of European Society guidelines, bempedoic acid received a Class I A recommendation. This is one of the highest recommendations that you can receive in those patients who cannot take a statin or can take a statin and are at high risk, so whether you can or cannot take a statin, you can use bempedoic acid. They actually attributed one complete section to bempedoic acid in the review guidelines. It was the only new agent to be mentioned. And why? Well, they actually stated the reason for that is because any drug that was mentioned and put in the guidelines was based upon data and data that leads to practice changing behavior. And that's what the CLEAR Outcomes data has done. So too early to tell how it will pick up in Europe because of this, but essentially bempedoic acid was represented as a foundational therapy to all lipid lowering, which is pretty impressive. Now, for the U.S. for guidelines, we're in several guideline consensus papers, but the official guidelines won't come out until 2026. As a matter of fact, at a conference last week, we announced that we've heard that the American College of Cardiology will actually be announcing those guidelines sometime early in the first quarter and then use the American College of Cardiology as a training program, so we'll know soon, January or February, and as it relates to competition, I've said this before, there's drugs being developed. There's an oral PCSK9 where you have to fast eight hours. You have to fast a half hour after you take the drug. Doing that every day, that's going to be really hard for patients for an asymptomatic disease. For the CETP inhibitor, be reminded, this is the fifth. There's four others that failed in practice. We really need to see what their outcome study looks like, but I think that's questions that they need to answer. For us, we're in the market now. We're expecting to be very prominent in the guidelines. As a matter of fact, we're already thinking about what resources can we start thinking about in developing in anticipation of new guidelines coming into the first quarter. We're already going to be using European guidelines with approved pieces in the U.S. just to educate physicians to see what updates have been made. That was very clear. So based on your last earnings update, bempedoic acid continues to demonstrate a strong commercial performance. Can you remind us how product revenues are tracking both in the U.S. and ex-U.S.? Yeah. So in the second quarter, we announced that we showed $41 million in U.S. sales for total revenue. $41 million was the U.S., but for total revenue was $87 million. This is based upon the work that we do with Daiichi Sankyo, et cetera. This was by far one of the best quarters the company has ever had. And again, we showed double-digit growth on essentially every single metric that we report on and even metrics we don't report on. So we have a lot of momentum. You can actually going out in the field. I do a lot of work with our field sales representatives and managers. There's a lot of excitement. We've made the message to use this drug a lot easier for physicians to understand. And with our payer coverage, it's a lot easier for them to get. We have 92% commercial coverage. We have 75% Medicare coverage. We're preferred in both of those segments. So it's really become a fun drug for our representatives to sell. It's really benefiting patients. And even going into the third quarter, we see continued momentum. So feel good about our business. Perfect. Same in Europe, by the way. They're doing really well. And now I just spoke to the CEO of Daiichi Sankyo Europe, and I asked him what he thought about the guidelines because he was still on holiday. And he said, "I'm just over the moon." He said, "We're essentially this drug will be used, it already is, but even more so because of the exposure of the guidelines in Europe. Potential expansion is also underway in additional territories, right? Yes. So let me talk about that. So Japan, and I want to be very clear about our milestones. So we are to receive up to $120 million in milestones from Otsuka Pharmaceutical. On August 29, they received a tentative approval. What does that mean? It's similar to the CHMP where the CHMP in Europe will give a tentative approval. You have to wait for formal approval. In Japan, you have to wait for formal regulatory approval and formal pricing, two separate categories. Once we get both of those, then we will look for those milestones. That'll happen sometime later this year. But that August 29 ruling is a very big de-risking that we see no barrier in sight of these drugs getting approved in Japan. It's the third largest lipid market in the world too. So we're very excited. Not only the milestones, we all talk about the milestones, but there's also royalties, revenue royalties that we receive once the drug is launched, and that's very favorable for us. Okay, and maybe from a longer-term perspective, over the past months, you've announced multiple settlements with ANDA filers. Can you talk about the terms and the importance of this for patent protection? Yeah, we feel really good about this. So in the past, we've always said that our patent goes till June of 2031, and that includes the pediatric extension. But we were always very confident that we felt that we had protection till 2040. And these settlements that we've just had, the past three, all three of these settlements have agreed not to launch before a date in 2040. That's very important. There's six more remaining. So stay tuned. More work to be done. But I can tell you we've already started planning past that June 2031 date. Awesome. So maybe changing gears into the early stage programs. You announced you introduced new next-generation ACLY inhibitor candidates for PSC. I think it's important to contextualize the disease a little bit. So can you tell us a little bit about the addressable population and the treatment landscape for these patients? Yeah. First of all, I would like to remind everyone just a quick commercial. If you go to our Investor Relations website, so www.esperion.com, go to the IR site. The entire presentation from April 24 is actually on for folks to watch. But let me just give the highlights. So PSC is a rare disease. There are 72,000 patients that actually suffer from this disease worldwide. Typically, if you're diagnosed with this disease, and it's somewhat of a hard disease to diagnose and comes on quickly, you're typically looking at a liver transplant in two to five years. With our program looking at ACLY biology, and just as a reminder, this candidate is not bempedoic acid. This is a completely different drug with its own IP, and we own the global rights. And it's the start of a program in our entire liver program. We haven't even talked about our kidney program yet, which we'll talk about later next year. 72,000 patients, this is worth more than a $1 billion opportunity globally. We believe that we have a drug that for the first time is a drug that will halt the disease and possibly cure the disease. Now, a lot remains to be done. We do have our final candidate. We've passed all the screenings necessary to say, "Okay, we can move forward." We'll be filing our IND next year and going into clinic soon thereafter. We're really excited about this. It was great to be able to demonstrate it on April 24. We're not getting a lot of credit for it. That's okay. But the fact that we were able to clean up our cap structure, show the growth that we've been able to do, and focus on our pipeline and developing this new agent just talks about the future of Esperion as well, how bright it is. Yeah, and can you summarize a little bit the most relevant outcomes that you've observed in preclinical models of the disease? I think the most relevant thing is what we've seen is just addressing the actual injury at the liver. I'm not an expert at cell metabolism and fibrosis, but Steve Pinkosky, who's done this, is. And he said that we have successfully found this intersection, which allows for a drug to really address the damage that the liver has from PSC and also provide for healing. So again, these are in animal models, et cetera. We'll have to wait and see what happens with the humans, but it's very promising. There's been a lot of candidates studied in this area and a lot have failed, like all drug development. But the fact that we keep moving along and a lot of the earlier barriers removed, we feel very good about it. Okay. In terms of timelines, you said IND? IND next year, soon into clinic, and we would hope to launch the drug sometime in 2029 or 2030. Okay, and besides PSC, are there additional indications coming down the road for? Potentially, but we haven't mentioned those yet. I think what's really exciting is what we're doing in our kidney program. And that could range anywhere from polycystic kidney disease to chronic kidney disease. And that would also be a very unique asset, different than the one that we've developed for PSC, very different from bempedoic acid, all using ACLY biology as a platform. Term not used much more, but platform. But the science around ACLY biology is very interesting and leads to discovery of a lot of other targets. Awesome. So would you like to clarify anything else that investors should be aware of? I would just say this is a very exciting story. Again, thank you for having us. We're very excited about the growth of the organization. We're very excited about the adoption of NEXLIZET and NEXLETOL. To me, the sky is the limit. We're highly undervalued, but we're really making a difference out there. We're always open to anyone that wants to do investor calls, et cetera. Thank you. Perfect. So thanks again, Sheldon. Great. Thank you. This was very informative, and we look forward to the progress of the programs. Thank you. Thanks. Great. Have a great day. Thanks.