Esperion Therapeutics, Inc. (ESPR) Earnings Call Transcript & Summary

Hello, ladies and gentlemen, thank you for standing by. Welcome to Esperion Therapeutics Strategic Update Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to Mr. Sheldon Koenig, President and Chief Executive Officer. Please go ahead, sir.

Thank you, Olivia, and good morning, everyone. Thank you so much for joining us this morning for the exciting news that we plan to deliver to you today and give you more information on it. As you had seen this morning, at 6:00 a.m. this morning, we issued a press release that Esperion Therapeutics and Corstasis Therapeutics announced Esperion's definitive agreement to acquire Corstasis, expanding our cardiovascular franchise with Enbumyst. Enbumyst is the first and oral-only FDA -- I'm sorry, is the first and only FDA-approved nasal spray loop diuretic for edema associated with congestive heart failure. We expect to leverage Esperion's established cardiovascular commercial infrastructure, and this also synergistically expands our product portfolio and accelerate double-digit revenue growth. Just to give you some quick information on the economics of the deal. This is an upfront cash payment of $75 million royalties on worldwide Enbumyst sales and up to $180 million in potential milestone payments tied to certain commercial and regulatory achievements. And turning now to our slide deck, our first slide, forward-looking statements and disclosures. I'll allow all of you to have the opportunity to read through that at your leisure. You may recall JPMorgan on Slide 3, we discussed Vision 2040. Corstasis Therapeutics acquisition is the Vision 2040 in action. You may recall, we have 3 pillars to support our strategy moving forward into the future. The first, strengthen and expand the bempedoic acid franchise. We will continue to unlock the multibillion dollar potential of NEXLETOL and NEXLIZET in the United States and globally. We want to build a multi diversified product portfolio. The acquisition of Corstasis allows us to do this. We're able to leverage our established U.S. commercial infrastructure to support product acquisitions, co-promotions, et cetera, and Corstasis is a great example of us using our infrastructure to do so. And of course, we have our pipeline, and we will continue to advance our next-generation ACLY pipeline with IND-enabling studies in our lead asset ESP2001 for the diagnosis of primary sclerosing cholangitis, more to come with that later in the year. Our overall goal, as we stated, is to achieve at least 5 marketed products by 2040 through a combination of business development and internal pipeline advancement. Turning to Slide 4. Let me quickly go over the Corstasis Therapeutics acquisition overview. A quick summary of the company, the lead asset Enbumyst, bumetanide nasal spray. This drug was approved in September of 2025 for adults with edema associated with congestive heart failure and hepatic and renal disease, including nephrotic syndrome. The drug has been commercially launched, and it does complement our portfolio, and we'll go in later regarding our target audience, et cetera, and you'll be able to see the synergies that we have to offer. There'll be additional presentations and pipeline products in development for congestive heart failure and hepatic and renal disease markets in the future. I broadly discussed with you the transaction summary, but again, keep in mind, Esperion will own the global rights to Enbumyst and all pipeline assets. Turning to Slide 5. I want to discuss with you the strategic rationale. This really builds on Esperion's deep domain expertise in cardiovascular disease and expanding presence in metabolic, hepatic and renal disease. We've talked before in our Vision 2040 that we want to be an organization that acquires products that would fit within the cardiometabolic structure that's currently out there. This acquisition expands Esperion's lipid management focus into complementary treatment for edema and congestive heart failure patients. Enbumyst offers unique patient-friendly delivery differentiating from oral/injectable competitors and capturing underserved outpatient needs. This also truly accelerates our double-digit revenue growth with high-margin product that is synergistic to Esperion's commercial footprint in cardiology, again, reinforcing the synergies that we have to offer with this deal. It provides compelling entry into a potential USD 4-billion plus addressable outpatient congestive heart failure market at attractive valuation multiples versus peers. Remember, I talked about the fact that we also have the global rights to this product. For the purpose of today, we'll be focusing on the U.S. market. But as time goes on, we will update you on our exploration of markets in Europe and beyond. Turning to Slide 6, the growing heart failure epidemic. Congestive heart failure is a growing U.S. epidemic. Congestive heart failure affects more than close to 7 million U.S. adults and is projected to impact over 8 million adults by 2030. The costs the nation estimated $47 billion in 2020 and is expected to increase to $142 billion in 2050. Congestive heart failure affects more than 10% in individuals aged 65 and older and remains the leading cause of hospitalizations in this age group. Following years of improvement, CHF mortality rates have shifted upward, changing from 108.3 per 100,000 in 2012 to 121.3 in 2019. CHF contributes to 452,000-plus deaths in 2023, and this is nearly 15% of all deaths in the United States. I'll also go as far as say that heart failure is one of those few metrics that hospitals are judged upon as it relates to readmissions. And you'll hear the term frequent flyer used by us many times. These are patients that have to continually come back to the hospital and get diuresed. One in 4 patients are readmitted within 30 days, driving significant health care costs. And this is what really drove Corstasis in developing this drug to say that we need something better. We need something that can address these folks that are continually being readmitted. The greatest expenditure for CHF treatment is estimated to be $8 billion to $15 billion annually with the most common cost due to need for IV diuretic treatment. There are 4 million hospital admissions 67% -- close to 70% of admissions are for diuresis only, and the length of stay is 4 to 7 days per admission. Hospital stays for acute decompensated heart failure are prolonged, and this averages close to $12,000 for initial hospitalization. I will now turn the presentation over to Dr. Dan Bloomfield, who will discuss addressing the unmet need. Dan?

Thank you, Sheldon. On Slide 10, I'll start by talking about the patient journey. You can ignore the text in the white boxes, it's busy, but the main point here is this vicious cycle of patient heart failure, coming into the hospital, going home, getting readmitted. As Sheldon said, 1 in 4 patients are readmitted to the hospital. So patients diagnosed with heart failure. In the next 2 years, they'll be coming to the hospital for an admission about 2 to 4x. And when they're in the hospital, they get diuresed and fluids taken off and doses of diuretics are increased to avoid future hospitalizations. But in the U.S., especially, there's a real pressure on length of stay and about half of the patients are discharged from the hospital with clear signs of congestion while improved from their admission, still exhibiting [indiscernible] edema that requires further diuresis. And that probably accounts for why 1 in 4 patients are admitted to the hospital within 30 days. So they go home with high doses of diuretics, they try to get the fluid off and patients will eventually reach back to the dry weight. They will return to their activities of daily living, and they may be home for a couple of months. But eventually, the amount of fluid overload will increase. They'll get short of breath, they'll get edematous and they'll initially go to the doctor's office often to get IV diuretics or have an increased dose of diuretics. But then they'll go home and over time, come back to the emergency room. And then in 4 out of 5 cases, they get admitted to the hospital, but in 1 in 5, they go home from the emergency room. So this vicious cycle is due in part to the fact that diuretics often become less effective over time. The doses of diuretics are increased over time. And one of the reasons why diuretics become less effective over time or oral diuretics is because when they get edema, they get edema in the gut wall, which reduces absorption and therefore, less of the diuretic dose is actually being absorbed and getting into the blood. So this cycle affects patient quality of life tremendously. There's always a balance of how much fluid versus the dose diuretics. It's frustrating for caregivers to have these patients come back and forth into the clinic. I'll go on to the next slide, Slide 11, which offers a vision of how Enbumyst could be an opportunity for intervening in this vicious cycle. Again, patients go home from the hospital, and they may still be volume overloaded. And so as you can see in the lower circle, they can potentially get Enbumyst as a way to continue the diuresis whilst they're home, that's required to get them back to the dry weight. Over time, they'll eventually end up with volume overload. And again, a time to intervene at that point would be to have them use Enbumyst to get more aggressive diuresis for a period of time and then settle back into their standard or their chronic dose of diuretics. So there's an opportunity to enhance diuresis when they go home from the hospital, and it can be used to avoid hospitalizations as the volume overload or fluid builds up. On Slide 12, I want to just talk about why Enbumyst stands out. So first of all, it's the only nasal spray diuretic that's out there. It provides rapid absorption. I mentioned it bypasses issues with GI absorption. It's very easy to use for self-administration. It has a similar effect on diuresis and natriuresis and as IV bumetanide, and we believe there will be improved compliance compared to oral tablets and IV injections. The clinical advantages, it treats edema and heart failure and hepatitis and renal disease. Essentially, if you need to take fluid off, Enbumyst can be used to help facilitate that. The doses can be individualized based on the dose required for diuresis between 0.5 milligrams and 2 milligrams. And as I mentioned before, it reduces hospitalizations risk by enabling at-home diuresis before they reach a stage that they have to be admitted. Bumetanide has been available for decades. It has a very favorable safety profile. And that safety profile is essentially the same as it is with inhaled bumetanide or Enbumyst. The cost savings will be based on differential pricing, the ease of use. It will overcome the variability of absorption, as I mentioned before, and avoid the need for IV diuretics. And I think it's important to recognize that this addresses a gap in current standard of care. This is a situation where right now, physicians and nurse practitioners have little choice when patients are buying overloaded and not responding to diuretics to increase the effectiveness of diuretics at home. And so that's a way these folks can avoid having to come to the emergency room or the doctor's office, and that's a gap that exists now that leads to this requirement for extensive care. And it's differentiated in part because of its form factor, it's less burdensome administration to the patients than IV diuretics or, as you'll hear in a second, subcu diuretics. On Slide 13, I want to compare 2 compounds, Enbumyst and FUROSCIX. FUROSCIX was one of the first therapies or probably the first therapy to offer IV -- offer subcu injections of furosemide or Lasix in the device that infuses the furosemide every 5 hours. It's a device the size of a pretty hefty soft covered book. It's put on to the abdomen. There's a needle that gets injected into the subcutaneous tissue, and then it needs to be infused every 5 hours, but patients have to remain supine or relaxed while that infusion is going on. The onset is fast and there's very mild site reactions and it's approved for edema weighing in pediatric patients as well as adult patients with kidney disease and chronic heart failure. In comparison to FUROSCIX, Enbumyst has a single-use nasal spray. There's no needles. You get 2 liters urine out about an hour, and it's very well tolerated. And again, the indications are broader, because you include hepatic syndrome as well as heart failure and renal syndrome compared to on FUROSCIX. It's the first nasal delivery system and is in the process of being launched now. FUROSCIX was launched in 2023. So the Enbumyst advantage is pretty clear, much easy to use a nasal spray that you have to lie down for 5 hours to get an infusion. The onset is comparable and efficacy is comparable, avoid site reactions. There's a slightly broader indication and it's very easy to use. And my last slide, Slide 14, is the target audience for presenting this novel innovative form of diuresing patients. So the primary audience are people who take care of heart failure. So cardiologists and heart failure teams are the key decision makers for managing fluid overload in heart failure. But it's not doctors necessarily that are the key people making these decisions. So advanced practice providers, such as nurse practitioners and physician assistants are the ones who lead frontline outpatient care for decisions on patient's fluid management. And the rapid development of these advanced practice providers over the past 20 years is a sign of the burden to a practice of these patients coming back over and over again. So adding these practitioners really improves the efficiency of the heart failure doctor's office. As a secondary audience, we hepatologists who treat volume overload and liver disease, again, with oral diuretics may be less effective and nephrologists where patients with complex renal function will also require increased doses of diuretics. And [indiscernible] audience is important, and that's health care assistance and payers. We believe that this will influence the protocols for managing heart failure patients, coverage decisions and system costs with our increasing focus on value-based care and care at home models. And with that, I'll turn it back to you, Sheldon.

Thank you, Dan. Thank you so much. Please if you address your attention to Slide 16, I want to discuss the annual U.S. market opportunity. This is a multibillion-dollar opportunity for us. If you look at the patient funnel going from left to right on a cartoon, you can see that there's close to 7 million chronic heart failure patients in the United States. 2.1 million, we believe, are addressable as it relates to the use of Enbumyst. The average cost of Enbumyst per congestive heart failure episode is approximately $2,200. This represents an opportunity of close to $5 billion for us from a market perspective. The value proposition or the goal of therapy is to reduce admissions and readmissions to improve outcomes and lower the cost of care. Turning to Slide 17. How does Enbumyst fit within our portfolio? Again, we believe that based upon our infrastructure and what we've said in the past, we can lend our infrastructure to effectively launch Enbumyst. Our current portfolio, as you know, is NEXLETOL and NEXLIZET. We have an established chronic cardiovascular risk management know-how within our organization. We have strong relationships with cardiology prescribers. We have existing payer coverage and formulary access and the relationships that go along with that. And we have a proven sales force who has executed in the cardiometabolic space for over 5 years. From a synergies and fit perspective, we expand from chronic lipid cardiovascular therapy to also acute congestion, volume management and heart failure. And make no mistake. Our attention is on maximizing the bempedoic acid franchise to the multibillion-dollar franchise, it will be and Enbumyst at the same time. We have the same target physicians. We can leverage our existing payer contracts and formulary access, and this also complements oral therapies with this novel nasal delivery that we have with Enbumyst. As you heard earlier from Dan, Enbumyst adds value in many ways. It addresses an unmet need in outpatient congestion, potential to reduce hospitalizations, and you'll hear more as we continue to launch this drug, our activities from a health economics outcomes research perspective, budget impact model, et cetera. We're differentiated versus FUROSCIX. This is nasal versus an infuser, easier use, better adherence. And I can tell you in many discussions we've already had with key opinion leaders, the one thing that really comes across is that this is easy to use. The upside from CKD, hepatic congestion indications aligns with our pipeline. As you know, we've talked about our pipeline from a liver perspective. Later this year, you'll hear what we're doing in the kidney area as well. This is a novel differentiated offering that we are just very excited about. Turning to Slide 18. The combined company, we're perfectly situated to attack 2 of the largest cardiometabolic markets, NEXLETOL, bempedoic acid, NEXLIZET, bempedoic acid plus ezetimibe and now welcome Enbumyst. We're in a strong financial position. We have a diversified product portfolio. We will reach sustainable profitability in 2026, and we've been very consistent about that. Durable cash flows, a strong balance sheet and attractive P&L profile. Our partnerships and pipeline, we continue the development of what potentially will be the most efficacious lipid-lowering product in the market with our triple combination of combining NEXLIZET with either atorvastatin or rosuvastatin. Corstasis RSQ-786 and 789 is a subcutaneous version of this drug that we're also working on. There's also a potential for a multi-dose and smart infusion system. And later down the line, there's even a potential for a veterinarian indication in heart failure in dogs. ESP-2001, I've mentioned, will be in the clinic by the end of this year, and you'll hear more about our kidney program through the end of 2026. Turning to Slide 19. This is a strong high-impact opportunity. We talked about the heart failure landscape, close to 7 million adults affected annually in the U.S. 16 million globally. So you can really see the global opportunity. There's an unmet need, limited outpatient options for fluid overload, and there are currently no nasal diuretics currently marketed. Addressable market of 2.1 million annual heart failure episodes per year. The hospitalization burden is close to $20 million. Cost savings and potential exist, and we're going to demonstrate that. And now we have an offering to also address this -- to address the economic aspects. Strong intellectual property to 2040, so it fits nicely with our Vision 2040. And the growth drivers are aging population, post-COVID CV complications, regulatory support for novel formulations. Heart failure has and always will be a significant unmet need. Turning to Slide 20. This is Vision 2040 in action, a transformational leap forward. We are perfectly positioned to aggressively attack 2 of the largest cardiometabolic markets, allowing us to further our mission of helping millions of patients worldwide. It's a really proud day for us. We're really excited about this opportunity, and we're looking forward now to taking your questions. Operator?

[Operator Instructions] Our first question comes from the line of Dennis Ding with Jefferies.

Congrats on the deal. I have one. So is it appropriate to use FUROSCIX as a launch analog? They did $15 million, $35 million and $70 million in the first 3 years, but they also only have 40 cardio reps in the first 2 years before expanding into renal. So given you guys have under 50 cardio reps, should we actually expect a faster launch ramp in terms of revenue for you guys?

Dennis, thank you for your question. Let me start off, and I'll ask John Harlow if there's anything that I missed to also chime in. It's really right now, it was one of the first products, as you heard, that was launched in 2023 to address this need for at-home market. So no analogy is perfect. You can never find in a perfect analogy. But to your point, I believe with the organization that we have with close to 155 representatives, we also have a very strong managed care reimbursement team. It really goes back to what we've said before from an infrastructure perspective. We also have a very significant health economic outcomes research team, and that will be very important to talk about some of the economic benefits that we mentioned today and publications, et cetera, that we have planned. We also think that we'll have a significant meeting presence. You heard from Dan that you have to be really tied to the heart failure community, especially in the area of nursing, and we'll be able to address that. So I think there's learnings from the analog. It's not the perfect analog, but it's the closest that you can get to when modeling success. And I do think we will be more successful, yes. John, did I miss anything?

No. The additional thing, Sheldon, that I would add is that the Corstasis team has launched this product, and we're looking forward to integrating that very small team into our organization and learn from what they've learned on their time in the market for about 3 months and looking to accelerate that growth.

Our next question coming from the line of Kristen Kluska with Cantor Fitzgerald.

Congrats on the acquisition. I actually have a couple of questions. I'll start with one at a time. Just mechanistically, do we see that the gut edema rates and absorption issues are similar amongst the loop diuretics? Or is there a case to make perhaps why one is more favorable than the other? Or is it really just coming down to the route of administration?

Dan, can you speak to gut edema and resistance?

Yes. Thanks, Jonathan. Good question. So it really just boils down to an oral tablet in the gut. All the diuretics are essentially the same in that regard. So gut edema is something that would not be able to be overcome just by changing the drug per se, but really the change in the method of delivery is really what's important.

And with the deal estimated to close in the second quarter, are you assuming that first sales should be coming in maybe starting in the 3Q time line? And how should -- how are you setting expectations for us just as we think about these first few quarters?

Ben, I'll turn it over to you.

Yes. We will have sales in the quarter that we close it. I think we are looking at figuring out how we can do a bolstered launch of this drug as quickly and fastly as possible after integrating it. I will say it will likely take a quarter to fully integrate and get the launch plans in place. So for the first one, I think you will see some revenue, but I think really after that is when it takes off and you start to see the impact of this being in our commercial organization.

Okay. And Ben, can you give us a little bit more color about the split about financing the deal through debt and the royalty stream? How much of this is coming from the Japanese royalty? How much is coming from the credit facility?

Yes. So we'll go into more detail that as we finalize those agreements and get closer to closing this. But I will say it's probably more heavily weighted towards the royalty monetization. The one thing that I really like about this financing structure is it achieves a few different goals that we set out to do, right? We're not releveraging the company after deleveraging it over the last 2 years. We are keeping dilution to -- we're not diluting. We're keeping this to a nondilutive financing mechanism. But at the same time, it sets us up to have the cash to both do the deal and effectively launch this drug. So in my mind, it's a really great financing structure here. We will go into more details in terms of the full terms, distribution and setup of that as we reach closer to close here. But I think rest assured, this is a great setup for the company and one that really derisks this product, this deal and this launch.

Okay. And one last question, if I may. Just you talked about the opportunity for intervention in 2 key segments maybe to start off. But given the dosing regimen, how should we be thinking about compliance and adherence as well?

John, do you want to address that, compliance and adherence?

Yes. So Enbumyst is really -- it's not intended for chronic use. It's somewhat of a rescue medicine. So adherence and compliance is not something that we anticipated being an issue. It's also a very easy-to-use product. It's in a well-established device, which is used in other marketed products. So we don't anticipate any challenges with adherence or usage.

Thank you, John.

And our next question is coming from the line of Joe Pantginis with H.C. Wainwright.

Nice addition to the sales bag. So I have 2 questions. The first one has, I guess, a bunch of components because it really revolves around the launch of the product. So I appreciate the comment right now that compliance shouldn't be an issue. That's really important. So I guess I want to talk about how is dosing driven? I mean it's at-home based on the information that I've been looking at, there are quantity limits with regard to how much a patient can get at one time, if. I'm correct. Is this something that a patient will self-assess? Do they need to call the doctor? So what sort of parameters triggers at-home dosing?

Let me start, and I'll turn it over to John as it relates to the dosing that's necessary. So Joe, typically, how these patients present, this isn't necessarily for the new -- the very first time a patient has heart failure. This is for that 1 in 4 that keeps returning within 30 days, and they develop symptoms. They have shortness of breath, dyspnea, they can't sleep. They're propping themselves up with pillows, et cetera. They have a history of heart failure, they call their physician. They pretty much know that they're filling with fluid again. They might have edema, et cetera. And I think that's really the trigger point. That's now. Further down the line, the company, Corstasis was actually working on also a potential wearable or technology that can actually notify the physician that a patient is symptomatic. That's more in the future. But now that's typically what gives away for a patient is they've had heart failure before. They know what it feels like. They know they need to be diuresed, and that usually triggers them to call their physician. John, do you want to speak to dosing?

Yes. So Joe, from a dosing perspective, each device comes in 0.5 milligrams. You can dose up to 2 milligrams a day. And with these patients, both the at-home patient, so prior to a readmission or admission or a discharge patient, patient coming out of the hospital, we anticipate a usage around 5 to 7 days. Obviously, the dosage is going to depend upon the severity of the patient.

No, that's very helpful. And then my second question, I guess, since this is essentially the beginning of the launch here, can you discuss any capacity needs moving forward? And what sort of the addressable population you can go to immediately? Yes, I'll just leave it at there.

John?

Sure. So as Sheldon highlighted earlier in the prepared remarks, we have a cardiovascular team that is focused not just on cardiovascular, but also primary care physicians. We are going to look to add Enbumyst into the bag upon closing. We are also -- there's the hospital marketplace, which is very important, which the current Corstasis team is also calling on those major metropolitan areas. And we are going to look to probably upsize that approach also. Again, there's 2 very important marketplaces. There's the at-home and then there's a hospital discharge. And so we're going to approach both of those based upon the tremendous opportunity that this represents for the organization.

But more towards any potential manufacturing needs for capacity of the actual device?

We believe from a manufacturing standpoint, we're in a good place right now.

Our next question coming from the line of David Amsellem with Piper Sandler.

I have just a few. First, on the competitor product, FUROSCIX. MannKind bought scPharmaceuticals for, I believe, it was $300 million upfront. So you're obviously paying a much lower upfront price point. So I'm just wondering if there's sort of a disconnect in your view here as you think of the 2 assets. I wanted to pick your brain on that. So that's number one. Number two, can you talk about the work you need to do in terms of access improvements? I know it's a new product, but just talk about Medicare access and Medicaid as well and what you need to do there to maximize assets? And then the last question is on exclusivity runway. How should we think about that?

Thanks, David. I think this is going to be a 3-tiered answer. I'm going to talk about the deal, have Ben Halladay give his comments and then turn it over to BJ Swartz as it relates to market access. So first of all, I can't comment on why MannKind spent close to $315 million on scPharma. But what I can tell you is that we believe that we have a better product. It's a great deal for us. Ben already talked about how we financed it, how we are not diluting the organization. And it's a drug that's very easy to use. As you know, the current FUROSCIX drug is a pump that you have to wear for 5 hours for an infusion and you have to do that for 5 days. Again, ease of use here is a nasal puff. This is typically a more potent loop diuretic, bumetanide. So I'm just going to say, hey, we're smart, and we did a smart deal. Ben, any thoughts as it relates to the deal comparison?

Yes. It's -- I mean, you can never compare 2 deals here. I think when you look at the structure that we have put up, the reason that we did it this way is because you had a team over Corstasis who truly believe in the potential of this drug and wanted to share in the upside. So they are very confident that this will be a very successful drug. We agree with that, and we set up a deal that accordingly recognize both of that confidence.

BJ, do you want to speak to market access high level?

Sure. David, you mentioned maximizing access and improvement there. First and foremost, Corstasis has laid the groundwork to engage initially with payers, both from the payer standpoint, distribution, et cetera. But what we look at here is the synergy of our current team, the relationships we have now, the contracts we have in place and leveraging those relationships on top of having our field reimbursement team as well to really work in those centers, as John said, we have the IDNs and those key centers of excellence. We could have that opportunity to use that field team there as well. And then also, it's just really -- we know that payers are laser-focused in this category just around the readmission. And most admissions to the hospitals around heart failure are about $12,000. So with that said, when you're looking from a CMS perspective, they are very much attuned to heart failure, the cost there and trying to keep those patients out of the hospital for readmission. So from a health economics outcomes research standpoint, real-world evidence, it will be critical, as Sheldon had outlined, from a budget impact to go to those regional health plans and really look at their actual patient population that is in heart failure and really meet that value proposition and truly have a value-based care discussion as well. I think there was a third question, too. Is there a third question, Sheldon?

No, I think that was it.

Yes. No, actually exclusivity runway. How are you thinking about that?

Ben?

I'll know that they have [indiscernible] patents and what we believe is strong IP out until 2040, as we mentioned in our prepared remarks.

Our next question coming from the line of Jason Zemansky with Bank of America.

This is [ Jackie ] on for Jason. First off, congrats on the deal. So what are your plans? I know you've talked about the sales force a little bit, but do you have any plans to expand? And how do you intend to reach hepatologists and nephrologist offices? And also, I know you started touching on this. But given the recent analogs of similar specialty products, how aggressive is or do you think Medicare will be in terms of management?

Let me just start off as it relates to Medicare. Again, this is a very high unmet need. This is one of the few therapeutic areas where hospitals are judged by CMS on readmission rates, and there's actually a connection between money that they receive for reimbursement of physicians as well and the pools that they are in and how they manage these heart failure patients. I think Medicare is always looking for solutions to better manage heart failure patients. And it's probably one of the few therapeutic areas where they are that aggressive. John, I'll turn to you as it relates to infrastructure and addressing nephrologists, hepatologists, et cetera.

Yes. Thanks, Jackie, for your question. So obviously, our primary target right now, primary audience is the cardiologists, the congestive heart failure care teams and then the advanced practice providers that are affiliated with those groups. From a secondary audience perspective, we are going through the target overlap analysis as we speak. We have, as you know, deployed a very robust digital approach for NEXLIZET and NEXLETOL, and we're looking forward to deploying similar nonpersonal promotion activities. And so we're going to look at a combined effort of both personal promotion to reach hepatologists and nephrologists as well as a digital approach.

I'm sorry, BJ, did you have anything that you wanted to add regarding Medicare?

Yes. I just think for Medicare, just to put it in perspective, again, I think we had mentioned that heart failure is a top condition targeted by CMS in general around this hospital readmission program that they have, and this is one of the top programs and top conditions that they look at. So I think it's really important that I know that most payers, Medicare payers are also looking for their star ratings through CMS. So this is really important. And so that's where we look at this as an opportunity. In addition, most Medicare Advantage plans both bear the medical and the pharmacy costs. So in that case, they're enrolled as MAPD plans, and so they're covering both the pharmacy and hospitalizations. And so very focused on that. So I just wanted to give some sense of -- we are laser-focused on that. That's our population, and that's where we will go to ensure that those patients are covered and get the prescriptions needed at the time.

Our next question coming from the line of Serge Belanger with Needham & Company.

First one regarding the TAM for the product. I think on Slide 16, I think it's described as potential $5 billion. I also believe MannKind has discussed similar numbers. So just curious how we should think about potential peak sales opportunity? And what are the keys to capturing this large TAM that currently appears untapped? And then secondly, again, I think MannKind is expecting an auto-injector product approval later this year. How do you think that will change the market dynamics? Is it just replaced infusion product or it really changes the overall market?

Yes. Let me start, Joe. Thank you for your question. I think as it relates to getting to the TAM to be aggressive, it's kind of the plan that we've laid out. Again, we have a very strong infrastructure. I think partnering. This is a -- heart failure is a smaller community as it relates to key opinion leaders. Nurses play a very large role in the use and decision of what drugs are being used as all -- as well. And again, it's the leveraging of our overall infrastructure. We've already talked about what we would do from a health economics perspective, et cetera. But I think also the biggest aspect here is the product itself. It's very easy to use. It's very convenient. And as it relates to the auto-injectors, we need to hear more about that. I believe it's 5 pens that are necessary to dose, one that actually is launched. We also are working on an auto-injector. But keep in mind that, that's just, again, gives a physician choice of what they want to use. We've heard from many key opinion leaders that we've spoken to already is that the ease of use of doing the spray in the nose is something that they've been waiting for, for a long time, this type of administration that makes it easy for a patient, get around the oral resistance, do the gut edema, et cetera. So that's why I would say as it relates to how we plan to aggressively go after this. The last thing I would say before I turn it over to John to see if he has any other comments in that. We've been searching a long time for the right fit. We've said before that we want to make sure that we find a product that fits well within our portfolio that we can leverage our infrastructure and be successful right off the bat that will allow us to have something that's already launched and be accretive as soon as possible. And that's what's led us to the acquisition of Corstasis. John, have I missed anything as it relates to sales or attacking the potential?

No, that was perfect, Sheldon.

Our next question in queue coming from the line of Paul Choi with Goldman Sachs.

Congratulations, Sheldon and team on the deal. A few quick ones from us, please. First, how are you thinking of time to peak sales? And how do you think about either peak sales or as a percentage share of the loop diuretic market? That's my first question. And my second question is, can you maybe just update us on how you think on the access side, potential step edits might evolve? Do you assume that patients will have to go through a generic first prior to getting authorization for Enbumyst? Any thoughts or clarity there would be great.

Ben, do you want to comment on peak sales and timing?

Yes. I'd say it's early to draw a line in the sand in terms of peak sales, but I think there's plenty of IP space in terms of us being able to maximize the value of this drug. We think that this is a large market. We think we've shown the ability to execute in a large market, and we are well poised to capitalize on the opportunity. But we're optimistic that there's a good opportunity here to capture a significant portion of the market given the considerable competitive advantages that Enbumyst has over all the other players in that market.

Thanks, Ben. BJ, do you want to address step edits?

Sure. We -- again, I just want to give credit to Corstasis as they really have done their homework prior to with payers as well. In this particular case, I mean, these are sick patients. These are heart failure patients. So they have been on oral meds. They have come into the hospitals again for readmission. So we don't anticipate step edits to be any different than the current products out there. And really, again, we'll go back to this readmission rate that we keep talking about is for those patients to be readmitted at $12,000 a pop, they really want to make sure that these patients have an at-home option. And so again, step edits from what we see and for Corstasis early work, seem to be normal and where you would think they would be with oral generics first and then taking them at home and then going into the hospital. And then now this provides that at-home option.

I'm showing no further questions at this time. I will now turn the call back over to Mr. Sheldon Koenig for any closing comments.

Great. Thank you very much. Again, I just want to emphasize that today is a very important day for Esperion. I'd like to say that we're really changing what this organization looks like, now entering into large -- 2 large therapeutic areas, our bempedoic acid franchise, which has been very successful, and we'll continue to make it successful. And now with the addition of Enbumyst and the fact that we also have global rights to Enbumyst, again, really changes the way to think about our organization as a global organization. And we'll come back to you in the future as it relates to our plans outside of the United States. Again, the goal of the Enbumyst therapy is to reduce admissions and readmissions to improve outcomes and lower the cost of care. This is a very high unmet need area, and we're proud to be a part of addressing that need. Again, I want to thank everyone for their questions today. We look forward to continuing to update you in the future, and have a great rest of the week. Take care.

This concludes today's conference call. Thank you for your participation, and you may now disconnect.