Hello, ladies and gentlemen. Thank you for standing by. Welcome to Esperion Therapeutics Strategic Update conference call. At this time, all participants on a listen only mode. After the speaker's presentation, there will be a question-and-answer session. 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. 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 only FDA-approved nasal spray loop diuretic for edema associated with congestive heart failure. We expect to leverage Esperion's established cardiovascular commercial infrastructure. This also synergistically expands our product portfolio and accelerates 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. Turning now to our slide deck, our first slide, forward-looking statements and disclosures. I've allowed all of you to have the opportunity to read through that at your leisure. You may recall J.P. Morgan on Slide 3, we discussed Vision 2040. Corstasis Therapeutics acquisition is the Vision 2040 in action. You may recall we have three 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 multi-billion 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, etc. Corstasis is a great example of us using our infrastructure to do so. 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, ESP-2001, 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 five 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, etc., 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've already 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 in 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 $4+ billion 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.
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. It 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% of 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+ deaths in 2023. This is nearly 15% of all deaths in the United States. I will 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. 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 four patients are readmitted within 30 days, driving significant healthcare costs. 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-$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 four to seven 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 patients with heart failure coming into the hospital, going home, getting readmitted. As Sheldon said, one in four patients are readmitted to the hospital. Patients go, gets diagnosed with heart failure. In the next two years, they'll be coming to the hospital for an admission about 2 to 4 x. When they're in the hospital, they get diuresed, and fluid's taken off, and doses of diuretics are increased to avoid future hospitalizations.
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 volume overload with edema that requires further diuresis. That probably accounts for why one in four patients are admitted to the hospital within 30 days. They go home with high doses of diuretics. They try to get the fluid off, and patients will eventually reach back to their dry weight. They will return to their activities they're 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. They'll go home and over time, come back to the emergency room. In four out of five cases, they get admitted to the hospital. In one in five, they go home from the emergency room. 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.
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 doses is actually being absorbed and getting into the blood. This cycle affects a patient's quality of life tremendously. There's always a balance of how much fluid versus without 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 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.
As you can see in the lower circle, they can potentially get ENBUMYST as a way to continue the diuresis once they're home that's required to get them back to the dry weight. Over time, they'll eventually end up with volume overload. 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 diuretic. There's an opportunity to enhance the diuresis when they go home from the hospital, and it can be used to avoid hospitalizations, as volume overload or fluid builds up. On Slide 12, I want to just talk about why ENBUMYST stands out.
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, we believe there'll be improved compliance compared to oral tablets and IV injections. The clinical it manages, it treats edema and heart failure and hepatic disease 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 mg and 2 mg. As I mentioned before, it reduces hospitalizations risk by enabling, at-home diuresis, before they reach the stage where 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. But 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. 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 volume overloaded, not responding to diuretics to increase the effectiveness of diuretics at home.
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. It's differentiated in part because of its form factor. It's less burdensome administration for patients than IV diuretics, or as you'll hear in a second, subQ diuretics. On Slide 13, I wanna compare two compounds, ENBUMYST and FUROSCIX. FUROSCIX was one of the first therapies or probably the first therapy to offer subQ injections of furosemide or LASIX in a device that infuses the FUROSCIX over 5 hours. It's a device the size of a pretty hefty soft covered book. It's put onto the abdomen.
There's a needle that gets injected into the subcutaneous tissue, and then it needs to be infused over 5 hours for patients have to remain supine or relaxed while that infusion's going on. The onset is fast, and there's very mild site reactions, and it's approved for edema weighing, and pediatric patients as well as adult patients with kidney disease and chronic heart failure. In comparison to LASIX and ENBUMYST has a single-use nasal spray. There's no needles. You get two videos of urine off in about 1 hour, and it's very well-tolerated. Again, the indications are broader because you include nephrotic syndrome as well as heart failure and renal syndrome compared to LASIX.
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 easier to use nasal spray than have to lie down for 5 hours to get an infusion. The onset's comparable and efficacy is comparable, avoid site reactions. It has a slightly broader indication, it's very easy to use. My last Slide 14, is the target audience for presenting this novel innovative form of diuretic in patients. The primary audience are people who take care of heart failure, cardiologists and heart failure teams are the key decision-makers for managing fluid overload and heart failure. It's not doctors necessarily that are the key people making these decisions.
Advanced practice providers such as nurse practitioners and physician assistants are the ones who lead frontline outpatient care for decisions on patients' fluid management. 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. Adding these practitioners really improves the efficiency of the heart failure doctor's office. The secondary audience will be hepatologists who treat volume overload and liver disease, again, where the oral diuretics may be less effective. Nephrologists, where patients with complex renal function will also require increased doses of diuretics. The tertiary audience is important, and that's healthcare assistants and payers.
We believe that this will influence the protocols for managing heart failure patients' coverage decisions and system costs with our increase in focus on value-based care and care at home models. 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 multi-billion dollar opportunity for us. If you look at the patient funnel going from left to right on the 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?
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 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. We have a proven sales force who has executed in the cardiometabolic space for over five years. From a synergies and fit perspective, we expand from chronic lipid cardiovascular therapy to also acute congestion, volume management, and heart failure. Make no mistake, our attention is on maximizing the bempedoic acid franchise to the multi-billion 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. 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 infuser. Easier use, better adherence. 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 were perfectly situated to attack two 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 RS-786 and RS-789 is a subcutaneous version of this drug that we're also working on.
There's also 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've talked about the heart failure landscape. Close to 7 million adults affected annually in the U.S., 16 million globally. 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.
Now we have an offering to also address this, to address the economic aspects. Strong intellectual property to 2040, so fits nicely with our Vision 2040. 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 two 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.
Thank you. Ladies and gentlemen, as a reminder to ask a question at this time, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, simply press star one one again. Please stand by while we compile the Q&A roster. Our first question coming from the line of Dennis Ding with Jefferies. Your line is now open.
Hey, Good morning. Thanks for taking my question and congrats on the deal. I have one. Is it appropriate to use FUROSCIX as a launch analog? They did $15 million, $35 million and $70 million the first three years, but they also only had 40 cardio reps in the first two years before expanding into renal. Given you guys have under 50 cardio reps, should we actually expect a faster launch ramp in terms of revenue for you guys? Thanks.
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. You know, no analogy is perfect. You can never find in a perfect analogy. 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. You know, it really goes back to what we said before from an infrastructure perspective.
We also have a very significant health economics outcomes research team. 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. I think there's learnings from the analog. It's not the perfect analog, but, you know, it's the closest that you can get to when modeling success. 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, you know, 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 three months and looking to accelerate that growth.
Got it. Thank you so much.
Thank you.
Thank you. Our next question coming from the line of Kristen Kluska with Cantor Fitzgerald. Your line is now open.
Hi, Good morning. 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? Is it really just coming down to the route of administration?
Dan, can you speak to gut edema and resistance?
Yeah. Thanks, y'all. Good question. It really just boils down to an oral tablet in the gut. All the diuretics are essentially the same in that regard. Gut edema is something that would not be able to be overcome just by changing the drug per se. Really the change in the method of delivery is really what's important.
Thank you. 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 timeline? How are you setting expectations for us just as we think about these first few quarters?
Ben, I'll turn that over to you.
Yeah. We will have sales, you know, in the quarter that we close it. I think we are looking at figuring out how we can do a, you know, bolstered launch of this drug as quickly and fastly as possible after integrating it. I will say it'll likely take a quarter to fully integrate and get the launch plans in place. 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. Ben, can you give us a little bit more color about the split, about financing the deal through debt and the royalty stream? you know, how much of this is coming from the Japanese royalty? How much is coming from the credit facility?
We'll go into more detail that as we finalize those agreements and get closer to closing this. I will say it's more heavily weighted towards the royalty monetization. The one thing that I really like about this financing structure is, you know, 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 two years. You know, we are not diluting. We're keeping this to a non-diluted financing mechanism. At the same time, it sets us up to have the cash to both do the deal and effectively launch this drug. 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. I think rest assured this is a great setup for the company and one that really de-risks this product, this deal, and this launch.
Okay. One last question, if I may. Just, you talked about the opportunity for intervention in two key segments, maybe to start off. Given the dosing regimen, how should we be thinking about compliance and adherence as well? Thank you very much again.
John, do you want to address that, compliance and adherence?
Yeah. ENBUMYST is really, you know, it's not intended for chronic use. It's somewhat of a rescue medicine. Adherence and compliance is not something that we anticipate as being a issue. It's also a very easy-to-use product. It's in a well-established device which is used in other marketed products. We don't anticipate any challenges with adherence or usage.
Thank you, John.
The next question coming from the line of Joseph Pantginis with H.C. Wainwright & Co. Your line is now open.
Hey, everybody. Good morning. Thanks for all the details today. I have two questions. The first one has, I guess, a bunch of components 'cause it really revolves around the launch of the product. I appreciate the comment right now that compliance shouldn't be an issue. That's really important. I guess I wanna talk about, you know, 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 1 time, if I'm correct. You know, is this something that a patient will self-assess? Do they need to call the doctor? You know, what sort of parameters, you know, triggers at-home dosing?
Let me start, and I'll turn over to John as it relates to the dosing that's necessary. Joe, typically how these patients present, you know, this isn't necessarily for the very first time a patient has heart failure. This is for that one in four 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. I think that's really the trigger point. That's now.
You know, 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. 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 wanna speak to dosing?
Yeah. Joe, from a dosing perspective, each device comes in 0.5 mg. You can dose up to 2 mg a day. With these patients, both the at-home patient, so prior to a readmission or admission or a discharge patient coming out of the hospital. You know, we anticipate a usage around five to seven days. Obviously the dosage is going to depend upon, you know, the severity of the patient.
No, that's very helpful. Thank you. My second question, I guess since this is, you know, essentially the beginning of the launch here, can you discuss any capacity needs moving forward and what sort of the addressable population you can, you know, go to immediately? Yeah, I'll just leave it there.
John?
Sure. As Sheldon highlighted earlier in the prepared remarks, we have a cardiovascular team that is, you know, 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, you know, calling on those major metropolitan areas. We are going to look to, you know, probably upsize that approach also. Again, there's two very important marketplaces. There's the at home, and then there's the hospital discharge. We're going to, you know, approach both of those based upon the tremendous opportunity that this represents for the organization.
More towards any potential manufacturing needs, you know, for capacity of the actual device.
We believe from a manufacturing standpoint, we're in a good place right now.
Yeah. Thanks for the details.
You're welcome, Joe.
Thank you. Our next question coming from the line of David Amsellem with Piper Sandler. Your line is now open.
Hey, thanks. I have just a few. First on the competitor product, FUROSCIX. You know, MannKind bought scPharmaceuticals for, I believe, it was $300 million upfront. You know, you're obviously paying a much lower upfront price point. I'm just wondering if there's sort of a disconnect in your view here as you think of the two assets. Wanted to pick your brain on that. 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. The last question is on exclusivity runway. How should we think about that? Thank you.
Thanks, David. I think this is gonna be a three-tiered answer. I'm gonna talk about the deal, have Ben Halladay give his comments, and then turn it over to BJ Schwartz as it relates to market access. First of all, I can't comment on why MannKind spent close to $350 million on SC Pharma. 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, you know, very easy to use. As you know, the current LASIX drug is a pump that you have to wear for five hours for an infusion, and you have to do that for five days.
Again, ease of use here is a nasal puff. This is typically a more potent loop diuretic, bumetanide. You know, I'm just gonna say, you know, hey, we're smart, and we did a smart deal. Ben, any thoughts as it relates to the deal comparison?
I mean, you can never compare two 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 at Corstasis who truly believe in the potential of this drug and wanted to share in the upside. They are very confident that this will be a very successful drug. We agree with that, you know, we set up a deal that accordingly recognized both of that confidence.
BJ, do you wanna speak to market access?
Sure.
High level. Thanks.
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, etc. 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, you know, we have the IDNs and those key centers of excellence. We could have that opportunity to use that field team there as well. Also it's just really we know that payers are laser-focused in this category just around the readmission. Most admissions to the hospital is around heart failure are about $12,000.
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. From a health economics outcomes research standpoint, real-world evidence, it will be critical, as Sheldon had outlined, you know, 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.
Okay.
Yeah, yeah. No, actually, exclusivity runway. How are you thinking about that?
Oh, Ben.
I'll note that they have Orange Book patents and what we believe is strong IP out until 2040, as we mentioned in our prepared remarks.
Okay.
Thank you. Our next question coming from the line of Jason Zemansky with Bank of America. Your line is now open.
Hi, this is Jackie on for Jason. First off, congrats on the deal and for taking our question. What are your plans? I know you've talked about the sales force a little bit, but do you have any plans to expand? How do you intend to reach hepatologists and nephrologist offices? 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? Thank you.
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, 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, 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.
Yeah. Thanks, Jackie, for your question. Obviously our primary target right now, primary audience is the cardiologist, 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 NEXLETOL and NEXLIZET, and we're looking forward to deploying similar non-personal promotion activities. We're going to look at a combined effort of both personal promotion to reach a hepatologist and nephrologist as well, as well as a digital approach.
Yeah.
Thank you. Our next question.
Oh, BJ. I'm sorry. BJ, did you have anything that you wanted to add regarding Medicare?
Yeah. I just think for Medicare, just to put it in perspective, again, I think we had mentioned that heart failure is the 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. I think it's real important that I know that most payers, Medicare payers are also, you know, looking for their star ratings through CMS. This is really important. That's where we look at this as an opportunity. In addition, most Medicare Advantage plans bear the medical and the pharmacy costs. 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.
I just wanted to give some sense of, we are laser focused on 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.
Thank you. Our next question coming from the line of Serge Belanger with Needham & Company. Your line is now open.
Hi, Good morning. Thanks for taking our question. Our 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. You know, just curious how we should think about scheduled peak sales opportunity and what are the keys to capturing this large TAM that currently appears untapped. Secondly, again, I think MannKind's expecting an auto-injector product approval later this year. How do you think that'll change the market dynamics? Is it just replace the infusion product or it really changes the overall market? Thank you.
Let me start. Serge, 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. You know, we have a very strong infrastructure. I think 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. You know, 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. I think also the biggest aspect here is the product itself. It's very easy to use. It's very convenient. As it relates to the auto-injectors, you know, we need to hear more about that.
I believe it's five pens that are necessary to dose, you know, 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 they've been waiting for for a long time of this type of administration that makes it easy for a patient, get around the oral resistance, due to gut edema, et cetera. That's what I would say as it relates to, you know, 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, is that we've been searching a long time for the right fit. You know, we've said before that we wanna 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 it'll allow us to have something that's already launched and be accreted as soon as possible. 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, that was perfect, Sheldon.
Thank you. Our next question in queue coming from the line of Paul Choi with Goldman Sachs. Your line is now open.
Hi, Good morning, Congratulations, Sheldon and team on the deal. A few quick ones from us, please. First, how are you thinking of time to peak sales? How do you think about either, you know, peak sales or as a % share of the loop diuretic market? That's my first question. My second question is, can you maybe just update us on, you know, 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. Thank you.
Ben, do you wanna comment on peak sales and timing?
Yeah. I'd say it's early to draw a line in the sand in terms of peak sales. You know, I think there's plenty of IP space in terms of us being able to maximize the value of this drug. You know, we think that this is a large market. We think we've shown the ability to execute in a large market. You know, we are well poised to capitalize on the opportunity. You know, we're optimistic that there's a good opportunity here to capture a significant portion of that market, given the considerable competitive advantages that ENBUMYST has over all the other players in that market.
Thanks, Ben. BJ, do you wanna address step edits?
Sure. Again, I just wanna 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. We don't anticipate step edits to be any different than the current products out there. Really, again, we'll go back to this readmission rate that we keep talking about is it, you know, For those patients to be readmitted at $12,000 a pop, you know, they really wanna make sure that these patients have an at home option.
Again, step edits from what we see and from Corstasis's early work seem to be normal and where you would think they would be with oral generics first and then, you know, taking them at home and then going into the hospital, and then now this provides that at home option.
Okay, great. Thank you.
Thank you. I'm showing no further questions at this time. I would now like to call back over to Mr. Sheldon Koenig for any closing comments.
Great. Thank you very much. I just wanna emphasize that today is a very important day for Esperion. I like to say that we're really changing what this organization looks like now entering into two large therapeutic areas, our bempedoic acid franchise, which has been very successful, and we'll continue to make it successful. 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. 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 wanna 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. You may now disconnect.