scPharmaceuticals Inc. (SCPH) Earnings Call Transcript & Summary

Good morning, and welcome to the scPharmaceuticals Commercial Day. [Operator Instructions] As a reminder, this call is being recorded, and a replay will be made available on the scPharmaceuticals website following the conclusion of the event. I'd now like to turn the call over to your host, John Tucker, President and Chief Executive Officer of scPharmaceuticals. Please go ahead, John.

So thank you very much, and thank you, everyone, for attending. We're very excited here at scPharma to talk about our commercial road map and the unmet need, both clinically and economically with payers for our investigational drug, FUROSCIX. FUROSCIX is in front of the FDA now with the PDUFA date of October 8. So next slide, Sara. Typical disclaimer with forward-looking statements to remind you, FUROSCIX is still an investigational drug, awaiting FDA approval with the PDUFA date of October 8, 2022. Next slide, Sara, to go over the agenda. We'll spend the first segment on the unmet need in heart failure. I'll give a quick overview, then I'll bring Dr. Bensimhon to talk about the clinical medical rationale and unmet need. And then James Kenney will come up and talk about payers and the economic need and unmet need. And then I'll come back on and do the commercial road map, how we're looking at the opportunity and how we're going to approach the opportunity and some new market research we have. We also have a panel here, Rachael Nokes, who's our SVP of Finance; John Mohr, who's Head of our Clinical Development and Medical Affairs; and Steve Parsons, who is Head of Commercial, who will be available for questions at the end of the at the end of the presentation. So to kick off the presentation on the next slide with a backgrounder on heart failure. About 7.2 million Americans have heart failure. This population is increasing. We expect to increase to greater than 8 million by 2030. Not all of these patients are really what we consider part of our opportunities. Some do well on their maintenance therapy. But we'll break down a little later, exactly how we segment these patients. But these patients do represent about 1 million hospitalizations. These are primary hospitalizations for heart failure in the United States. We know there's approximately 3 million other hospitalizations where heart failure is involved as well. Big thing here is how much these hospitalizations cost. Hospitalizations related to heart failure are projected to continue to increase by about 127% and from $21 billion in 2012, almost $70 billion in 2030. I think what's really amazing is just think about $244 cost for every adult -- for every adult in the U.S., if you just look at how many heart failure patients and how much it costs and then spread it over the entire adult population. These are the most expensive patients that Medicare deals with. This is why it's such a big economic problem. And the majority of these costs, no secret, are really related to the cost of hospitalization. And the biggest reason these patients are hospitalized, about 65% of the time is just because of congestion. They are uncomplicated cases, that all they need is an IV diuretic. They don't have any procedure needs. They just need enhanced diuretic response that it's only really available in the hospital. So the opportunity is to give them that enhance that 100% bioavailable diuretic, but to give it outside of the hospital to reduce unnecessary hospital admissions and readmissions. And this is really the only way to significantly drive down these heart failure costs. And that's really what we're trying to show you and accomplished with FUROSCIX. Next slide, Sara. So this kind of gives you a quick snapshot of the problem. So heart failure patients represent about 11% of the entire Medicare population but they're about 41% of all the admissions and 53% of all the readmissions, and the readmissions are patients bouncing back to the hospital after 30 days. So approximately 10% of the patients account for almost 50% of all the hospital admissions and readmissions. This is why they're so expensive to treat heart failure patients. If you look at the total Medicare Part A and B spending, what is spent in taking care of heart failure patients is about 1/3 of that entire Part A and Part B bucket. Again, these are the most expensive patients in Medicare. If you look at the cost of a hospitalization, if you just look at the DRG, it's about $11,840 but if you ask someone like Dr. Bensimhon, it could be up to $20,000 for hospitalization to care for a heart failure patient and a heart failure event. And the cost of these events has driven 80% by that hospitalization. So again, the goal here reduce the cost by reducing the need for hospitalization and readmission. So next slide, Sara. A little bit about the patient journey. I mentioned the 7 million patients that have heart failure in the U.S. Some of them do great. They're on their maintenance medication, they're on an oral diuretic and they're doing fine. But something happens, natural progression of the disease, non compliance to diet, no exercise, we've seen this a lot around the holidays. Where mom's cooking, doesn't want to take all diuretic and then gets in trouble She starts taking on fluid. This is really the hallmark of heart failures is this retention of fluid. But the issue is when they start having gut edema, the bioavailability of that oral LASIX that oral diuretic they're on actually decreases and becomes incredibly variable. So a patient could be taking 80 milligrams of oral LASIX and actually having access to 8 milligrams of this. So just as the patient is starting to take on more and more fluid, the bioavailability of the oral goes down dramatically. These patients are in trouble. What do they do? They call their doctor. The doctor might try to double their oral just to get more diuretic onboard. But a lot of times, these patients just can't catch up and they need to be admitted in the hospital to get 100% bioavailable FUROSCIX. That's the IV. So these patients are admitted in the hospital. We know 80% of them again are directly attributed to the volume all the load, half of these can be avoidable. Half of these patients really don't need to be hospitalized. They're just getting a diuretic. And when they're -- so they stay in for 5 days, their discharge and up to 50% of them are discharged with residual congestion or discharge wet. So what -- and what happens then is about 30% of them are readmitted in the hospital. So the patient will stay in the hospital for 5.2 days, be discharge and about 1/3 of them will be back in that hospital within 30 days. You have an opportunity to prevent the admission and then an opportunity to prevent the readmission, which really drives the cost. So next slide, Sara. When we look at the opportunity, we really look at 2 kind of windows, what we call the prevention window. And I know, Dan -- Dr. Bensimhon will talk a little bit about how edema progresses. But we really look at this prevention window in this patient, first part taking on fluid, first starts gaining weight. First starts having swelling in their extremities, can't get their wedding ring off, ankles are swollen. Right there is an opportunity to intervene before that patient gets so sick takes on so much fluid that they have to be hospitalized. So intervening right there with 100% bioavailable Furosemide. Do it right there, keep that patient from getting so sick they damage their heart and have to be hospitalized. We know some patients, and we saw a lot of this in COVID for these patients. These are heart failure patients. The pre-sick patients, even before COVID, they were the ones now susceptible for nosocomial infection and really having a poor outcome being hospitalized. With COVID, we hear stories of patients basically just drowning in their fluid because they were terrified to contract COVID in the hospital. So this really gives patients and physicians an opportunity to prevent that patient getting so sick, they need to be exposed to a hospital and for a payer not to take on that hospitalization cost. However, we know we'll never get 100% market share and some patients await too long to call the doc, and they will be hospitalized. So we will look at that when they come out of the hospital. And I'll show you some data on this a little later. They're really at risk of being readmitted. We know 50% of them are still residually congested. If you had an opportunity with an agent that was 100% bioavailable without being hospitalized, intervening right there, you can keep those patients from being readmitted into the hospital. So how are we going to do this? How are we going to do this? We know we need something that matches the IV, that matches that 100% bioavailability of the IV. The physicians have been using IV Furosemide for 50 years to treat congestion, but they've been using it in the hospital. So we look to try to figure out a way to provide 100% bioavailability and give it in a way that the patients can do this at home before they get so sick, they have to be hospitalized or rehospitalized. Now with the FDA came up with a formulation that we could deliver subcutaneously. The problem with the IV is just got a pH over 9, so it can't be delivered subcutaneously. So we were able to create, a patented, 100% bioavailable formulation of Furosemide that was pH-neutral. We knew we had delivered over time to match the PK of the IV. So if you go to the next slide, There, we'll show you how we've been able to do that. We partnered with West Pharmaceuticals, and this is the device, the infuser here on the right. It's the same platform that Amgen used with Repatha, so the platform has been already approved, albeit 3.5 ml platform. But this really allows us to deliver Furosemide, which is the most widely used oral or IV diuretic but be able to deliver it over time to match the PK of the IV. So we have a pH neutral formulation. We need to deliver it over 5 hours to match the idea of the PK but we need to deliver on a biphasic delivery profile. We need to give a bolus dose to get to patients diuresing to start the diuresing process and then continue more of a linear dose over the next 4 hours. The only device that can do this and be simple for patients to use is really the West Pharmaceuticals smart dose preloaded cartridge. So again, this technology is approved by the FDA and EMA, and it really allows us to give a patient an opportunity to have 100% bioavailable Furosemide on a small wearable patch doesn't interfere with their activities of daily living, but can get the fluid off in a way that's safe, effective, keeps that patient from getting so sick they need to be hospitalized or rehospitalized, giving superior patient outcomes and reducing health care costs. So how do we prove this? The next slide, Sara. Now with the FDA, we conducted a study, a PK study, it's a 505(b)(2). So what we needed to show was that the PK of our subcutaneous matched the PK of the IV. And you can see on the left, the orange is the IV. You have a big spike there. That's really just waste the drug. The kidneys or can't handle that much diuretic. And the blue is a subcutaneous. But what this shows that the absolute bioavailability was 99.6%, met with the FDA, they agreed this is similar looked diuresis, urine excretion, and they were the same, both 8 hours and 24 hours before -- between the IV and the subcutaneous. So we have a successful study in the eyes of the FDA, and they've reviewed the study but this is also the study that physicians need, physicians what they want is the ability to take this excess fluid on but be able to do it where they want, when they want, and when they want to do it is as soon as that patient starts getting in trouble. Now they try all of these things and Dan will talk more about doubling oral having nonloop diuretics, anything to keep them from having to go to the hospital and get IV 100% bioavailable treatment. We're able to give this to them now in their home. And so this is what doctors need to see is similar bioavailability, similar diuresis. And so this is what our pivotal study was. Next slide. So that's the introduction to the problem and to our solution. I'll come back in a bit with more of a commercial road map. But right now, I'd like to turn it over to Dan Bensimhon. He's the Medical Director of the Advanced Heart Failure and Mechanical Circulatory Support Program, Cone Health in Greensboro, one of the -- probably one of the largest heart failure clinics in the country. So Dan, do you want to take over?

Yes. Thanks, John, and thanks for having me today. For those who are not familiar, with Cone Health were a 6-hospital system in Central North Carolina, we recently won a Watson Top 50 award for one of the best -- 15 best cardiovascular hospitals in the country. And really, a lot of this work is centered around the work we've done in our heart failure program. We have a very advanced heart failure and shock program, a VAD program. But we spend a lot of time thinking about heart failure. We have over 3,000 patients in our heart failure clinic. And we've really focused on how do we transition patients care from inpatient to outpatient. And we put a lot of resources behind it. And I was listening to your discussion, and I really appreciate some of the things you brought up. I don't think it is possible to overestimate the importance of this of what we're discussing to the heart failure world. We've had a lot of -- some of the smartest people I've ever met are in the heart failure world. We've had a lot of smart people thinking about this problem for a long time. And yet, the majority of health systems in the country get millions of dollars and penalties for heart failure readmissions. We have all these people saying, how do we keep these patients out of the hospital, yet about 1/4 of the patients, 25% of the patients still get readmitted in 30 days. And the issue is -- and if you really spend a lot of time thinking about it, the issue is that not that we haven't thought about it, right? The issue is we really don't have the correct tools to deal with the problem. It's like sending -- I always make the joke when I'm talking about this. It's like sending a carpenter out with a toolbox, giving them a screwdriver, giving them a hammer but you don't give them a Phillips screwdriver, right? They can only solve a certain amount of problems because they don't have the right tools. And this has really been an exciting journey for me. I think the studies we've done and the things we've looked at shows us. We now have that tool that we've been missing. And I think we're really going to see our ability as you'll see from a couple of studies we present, you'll really see that our ability to fight back in this battle, the playing field has now changed. So if I have -- I think I have a few slides here, if you don't mind, advancing to the next slide, I'd love to talk about it. John, as you mentioned, our primary issue here is congestion, right? 80% to 90% of the people who come to the hospital or have heart failure symptoms, have it because they have congestion. They have flu in their lungs, they have flu in their belly. They have flu in the legs. Not only is it the reason they come to the hospital, but it's also the reason they feel bad, they can't do their activities of daily living. They have reduced quality of life. And it is really the sentinel part of what we deal with as heart failure physicians. We've had LASIX for a long time. People say, wow, this is really easy. You should just be able to give them more LASIX, it's like managing blood sugar, you have too much blood sugar, you give them more insulin. Well, -- as you'll see from the next couple of slides, there's an inflection point where the tools in our toolbox, no longer work. And we know if people have residual congestion, which is very common, we have studied congestion at our center, at every site, people coming to the clinic when they come in for routine visits, people leaving the hospital, they walk around 40% of them walk around overly congested. They are on the precipice, they're in the brink at any time about being readmitted. And our tools, as we'll show you, have really not been suitable to address this. So if you go to the next slide, we'll talk a little bit more. So this is a graph by Mihai Gheorghiade, and this really speaks to part of the problem. And what this shows is -- we all know that heart failure is a progressive problem. The mortality of heart failure approaches 50% over 5 years. And you can see and what Dr. Gheorghiade showed is that this is not a linear problem. When people come into the hospital for fluid overload and as you mentioned, the majority of people who come to the hospital come for fluid. And when they come in, those hospitalizations represent a punctuation at which point their heart failure accelerates. So every time they come into the hospital, it's no, "Oh, we get them in at a hospital, they go right back to where they were." They actually have a more rapid progression of their heart failure from these hospitalizations, whether it's from the fluid or something else sustained, but we know hospitalizations are associated with worse outcomes. And you can see on the right of the slide, with each subsequent hospitalization your mortality decreases or mortality increase, you get worse mortality. So much so is that one of the things we talk about on teaching rounds when patients get admitted for heart failure, if we admit 3 patients for heart failure today, and we've already seen those 3 this morning in our -- on our morning rounds, we have admitted 3 more so far already this morning. One of those 3 people will die in 1 year. 1/3 of all heart failure patients admitted will die within 1 year of their hospitalization. These are sick patients. They have a lot of need. They require a lot of resources to manage this patient population. And as the population ages, this population just keeps getting bigger, and bigger, and bigger. Next slide, please. This is an interesting slide. 10 years ago, we didn't have this understanding on this slide. This information on this slide really comes from the last 10 years of work and several studies that we participate in, in our institution. And what this shows is this comes from invasive heart failure monitoring for devices like CardioMEMS and other devices where we're able to monitor fluid overload real time in patients. What we used to think is patients are doing well, their weight really hasn't changed. They're doing well. And all of a sudden, something tips them over 2 or 3 days later than in the hospital getting IV diuretics because they got really sick. And that's not really how it happens at all. What you see is it's a 2- or 3-week process of deterioration before someone has a hospital admission. So if you look at the right of the graph, the right of the graph is the index hospitalization. And then you see a 5-week period running up to that index hospitalization. And you can see the blue line is dyspnea, the orange line is weight gain, the dark blue line is edema. You can see for the first week or 2, these patients are accumulating fluid, but yet they're not really getting a lot of symptoms. So finally, when they come to the clinic, there are 2 or 3 weeks in to their deterioration. And now they have fluid in their gut, now they have fluid in their legs. Now they're starting to have fluid in their lungs, and they're starting to get symptomatic. And at that point, they call, they come in and we say, okay, double your LASIX and we'll take care of this. Well, a good proportion of those people, at least 1/3 of those people have the cardiorenal syndrome, which means that they will not respond adequately to changes in oral diuretics, and they will continue to progress. But now we only have about a week's worth of time to keep them out of the hospital because they weren't symptomatic for those first couple of weeks. So whatever therapy we choose at that time, we have to have make sure that therapy is effective. So we can double their diuretics if that works, great. Everybody is happy. If it doesn't work, then the really the only 2 options left is, one is to hospitalize them. And Steve Greene at Duke as a colleague has shown that 2/3 of all our hospitalizations in the country for heart failure are simply due to the net need for IV diuretics. Nothing else happens during those 4 or 5 days. People just get IV diuretics, it cost them $15,000 or $20,000 for 4 doses of IV diuretics and they're let go. Or the second option is to give them IV diuretics, IV LASIX in the clinic. And whoever doesn't do this, they say, well, it's a no-brainer, bring them into clinic, give them IV diuretics, everybody is happy. Well, if you run a heart failure clinic, you realize that is a big ask, right? You got to get the IV in the patient, the patient has to stay in clinic to monitor them for a little while. They get one dose. They have to come back the next day for another dose. And now you have to have them drive home an hour and they're peeing in the car. This is a really big deal. And the folks at Hopkins, Stuart D. Russell and Dr. Malhotra studied this, and they showed that if you give a heart failure patient who's decompensated, IV LASIX in the heart failure clinic and you give them one dose, 54% of them will get readmitted anyway. So you went through all the trouble to give them one dose of IV LASIX and over -- almost 2/3 of them get admitted anyway. The issue is you need that bioavailability of IV LASIX, but you need it more than once and you need to give it to be able to give it to a patient when they're decompensating, otherwise, you're going to lose the window to take care of them. So when I say we need a tool in our toolbox, we got oral diuretics, they work great and stable patients. They're the main stay of therapy. We have IV diuretics in the hospital. They work great but we have this 1.5 to 2-week gap where we have nothing that works reliably, and this is why emergency room physicians will not send patients home from the hospital. They understand this. They understand that if you come to a hospital and say, I have heart failure and I'm short of breath, there's a 90% chance you're going to get admitted from our ER if you come from heart failure. Whether you have a lot of fluid or not because the ER doctor is not going to take the chance because he or she realizes that there's a window here. We're just saying double your oral LASIX isn't going to work. And they don't have a tool to send them home with to say use this instead. So they just bring them in and we admit them, and that's why the readmission rate is 25%. So what we really need is we need this Phillips screw driver. We need something in the middle. And it's not because we haven't been in -- I really get frustrated at people saying, well, you're just not thinking about this, right? You got to be able to do this. we have -- we've tried everything. We've tried other diuretics. We take really smart people have attacked the problem. We just don't have the tool. So next slide, please. So this is a study, FREEDOM heart failure study, which really, I think, is a landmark study, and we were -- our institution was central to this study. And -- what this study did? And I think it's really important to understand how this study worked. These were patients who presented to the ER with heart failure. So they had known heart failure, and they presented to the hospital ER and said, I'm short of breath, my heart failure is worse. And the hospital -- the ER doctor said, okay, we're admitting you to the hospital. So the decision to admit the patient to the hospital was made already. And we -- the patient had to meet certain criteria for relatively uncomplicated heart failure. They couldn't be hypotensive, their creatinine had to be -- renal function had to be relatively stable. And we said, "Well, you mind if we send these patients home with a couple of doses of FUROSCIX and see what happens and so the ER docs said, okay, we educate them about that. So 24 patients enrolled in this trial. Once again, I am going to reiterate to you, all of these 24 patients were just about to walk into their hospital room and get admitted. We gave all those 24 patients. We sent them home with FUROSCIX, and we kept 23 out of 24 of those patients out of the hospital for more than 30 days. So we were remarkably successful in u-turning, not only preventing hospitalization, we u-turned these patients. And this is in the hands of people who -- this is not a general clinic. This is in the hands and hospitals of systems where we're really good at heart failure. And if you look at that compared to controls, if you -- if this is really a cost study, if you look at it compared to controls, just related to the heart failure costs, we saved $17,000 per patient. And we realize that about -- based on the studies we've done, they're about 50% to 60% -- we -- 50% to 60% of patients who get admitted to our hospital from the ER probably can be u-turned. And we have 140 hospital admissions per month at our main hospital for heart failure. So at $17,000 a patient, you can see the p-value is incredible. And when you compare overall health care costs, when -- as you mentioned, John, people come to the hospital, they have bleeds, they have nosocomial infections. When you look at over cost utilization, it's nearly $30,000 per patient. So if you need any more proof that you just gave us the tool to fix a lot of our problem, that's why I think it's really been a great opportunity for our hospital center to participate. And now any time I go and give talks about new heart failure therapies, new heart failure devices, all of the nurse practitioners in the room who do this for a living, say, "Well, well, well, go back to that subcutaneous thing. I want to talk more about that." because this is their problem. This is what they do day-to-day and they're left without the tool to fix it. So I couldn't be more excited about what's coming down the pipe. We have -- we just released more of our data about the at-home trial in partnership with Dr. Udelson at Tufts. Hope we'll get to talk about that a little bit later, but that also showed nearly a 40% reduction in heart failure admissions from patients who are fluid overloaded in the clinic. And it's just remarkable data. We are using a medication that we know how to use, we're all comfortable with it we just now have a new delivery system in which we can really expand what we do. So I think that's all for me. I don't know if there's anything else in my slide deck. I'm happy to take questions at the end, but I'll turn it back to you guys.

Okay. Great. Thank you very much, Dan. That was great. So now I'd like to introduce James Kenney, Founding CEO of JTKENNEY. He's a former Manager in Specialty and Pharmacy contracts at Harvard Pilgrim and former Academy of Managed Care Pharmacy President. So Jim, thanks for joining us, and welcome.

Thanks, John. Very happy to be here. If we could go to the next slide, please. Just to give you a quick background, I actually managed a specialty pharmacy contracting benefit design, formulary at Harvard Pilgrim, so lots of experience sort of managing drugs in this space. And I think what we see today is we're very good at managing drugs specifically where we're struggling with is medical costs and how do we manage these medical cost arrangements, if you will. And as we get these new products that come to market. The plan itself and the payer is responsible for both medical and pharmacy, and we're working primarily for employer clients. In some cases, the plan is at risk. In other cases, the employer is at risk for those lives self-insured accounts, which is about 50% of the market at most major plans. We also have a number of providers who are at risk as well Dr. Dan talked about these hospital systems where they try to keep these patients out of the hospital, if they get a readmission and they have to pay for the cost of that readmission, that's part of their financial risk as well. So we have an opportunity like this with a product, with orals fail, we have an opportunity to get some savings into the system that's quite significant. And we saw earlier in the commentary that they do present to the ED, 66% are admitted for this IV treatment. And the payers really don't have any choice. Once the patient hits the ER or the ED, once they get admitted, they're basically going to cover the cost of that unless there's a risk contract in place that's going to cover them in the event of readmission, but otherwise, there's really not much of an opportunity. If we look at the PBM's perspective here, they're primarily responsible for pharmacy benefit management and they typically evaluate products fairly quickly making decisions on those. But that primary focus is on outpatient drugs, but they do have the ability to drive new products on multiple formularies. If we look at the IDN, integrated delivery networks, they're accountable for the care of these patients, both as they come into the ED and with the inpatient admissions. And again, they bear significant risk in the Boston market, all the large multi-specialty group practices, the IDN often have full risk contracts with the payers in the marketplace. So anything that's going to reduce the cost of hospitalizations or medical costs in general that are related to their systems is significant. The DRG reimbursement averages about 3.9 days, the average hospital stay is 5. Again, there's some losses there, if you own this population. As we saw 1/3 of the patients in Medicare are affected with this condition and are driving the cost of Medicare spend, if you will, and the bulk of that being hospitalization. And again, they have the highest readmission rates, and this impacts star ratings increases costs. So again, we're always looking for new drugs to deliver medical cost offsets. Really, do we have a situation where the drug will actually deliver savings beyond the cost of the drug. I know we haven't talked about that, and that's not part of the call today. But that's going to be significant. When we look at $15,000, $20,000, $30,000 cost for hospitalization, being able to offset some of that cost is quite significant from a payer's perspective and something that the payers are going to be driving, the employees are going to be interested in. And certainly, the at-risk providers as well are very interested in the ability to save those costs and use that money for other things. Next slide, please. Again, the FUROSCIX solutions, medical cost offset is the clear value proposition here. Every manufacturer tells us we've got a drug that's going to save our medical costs typically, the medical cost offset doesn't come anywhere near the cost of the drug. In this case, it's going to be a significant difference. The options for decompensating patients after oral has fail as we've heard, an alternative to the ED visit, I really like Dr. Dan's expression of u-turning these patients. Ideally, that's what the payers would like. If we could prevent that initial hospitalization, we can save on that significant burden, if you will, and that reduction in hospitalization also trails with a reduction in readmissions. So in some cases, where the hospital is not at risk for the readmission the plan is or the employer is, again, the plan may be paying twice for the same patient within that 30-day window. So again, a significant cost savings opportunity from a payer perspective. Again, the PBMs, as I said earlier, primarily managing the outpatient benefit. However, they do have a responsibility to their clients. They work directly for employers. They obviously work for payers. The payers are typically managing the medical side of the house, but this is an alternative to the ED and a possible inpatient treatment. So this is something that PBMs will get behind. The payers will get behind to say we want you to make this available on the formularies and it aligns with the strategy of effective outpatient drug management that ultimately reduces medical spend. And then for the IDNs, obviously, an alternative to a constant inpatient treatment. It avoids that exposure to that DRG reimbursement gap. And again, that's the average 3.9 versus 5. There certainly can be patients that may be in for much longer period of time, depending on the stage of disease that they're in Dr. Dan point that obviously saw with each successive admission, their heart failure condition worsens which likely would lead to longer length of stay. And there's no benefit there. And the length of stay benefit doesn't necessarily help to sell a product to the payer, but it certainly sells it to the IDN and the hospital because that's where they're losing money on these patients on a regular basis. And lastly, it eliminates those readmission penalties and any negative impact it may have on star ratings. So overall, if we can have a significant medical cost offset with a product, that really is the most important thing a product can offer us today because we have to be satisfied with the drug, we have to cover the cost of the drugs, and we can manage drugs very effectively through formularies and benefit design. What we can't manage is that medical expense when the patient hits the hospital. I think that's my last slide, John. Great.

Thank you, thank you, Jim. And again, both Dan and Jim will be available for questions after we take this last portion. So what I'll do now is give a little bit of a commercial road map where we are, how we're thinking about the market and how we're going to approach the market. On the next slide, just to, again, articulate what the size of the market is. We've talked about the problem. The number of patients, the issue with them getting sick and being rehospitalized and the cost. So it's a big problem. There's also a big opportunity. I mentioned 7 million patients. Not all these patients decompensate, not all of these patients will have a worsening heart failure event. But about 1 million to 1.5 million do, and they had about 4 million episodes a year where they need some sort of enhanced diuretic response. We think about 2.1 million, roughly half of them will be addressable with FUROSCIX. Not every patient is our patient. A patient has some form of dementia, probably not a great candidate. Patients that do resolve from the oral -- doubling of the oral, not necessarily our patient. We do these 2 million addressable events. Double of our pricing at $700 a unit. We think there'll be 4 units per course of therapy, so about $2,800 for a cost of care which gives us about a $6 billion accessible market opportunity. At 17% share, it's over $1 billion, over $1 billion market. And really, what we're trying to do is get these patients back on their oral LASIX, their maintenance dose, without them having to be hospitalized or rehospitalized. So this is the opportunity of about $6 billion. Let's talk about next slide how the stakeholders are aligned. How do you define a successful product or a successful launch? Really, the key thing is having stakeholders aligned. And this is different for a lot of drugs that launched. For the payer, the average cost, and this is just the DRG is $11,840, we know and Dr. Bensimhon talked about it that for some of these patients, it's $20,000 to have a patient admitted. And this is what the payer pays at a hospital. Also, we know heart failure is a top condition targeted by the hospital readmission reduction program. So even CMS recognize that how we were treating these patients was inefficient that 1/3 of these patients, you're paying $12,000 to $20,000, and then 1/3 of these patients are back in the hospital within 20 days. So this is why CMS instituted this program, which actually penalizes the hospital for excess readmissions for heart failure. And we know where Medicare is going, it's going through advantage plans, over 50% of the plans, and it's going to be over 60% shortly [ on mortalize ] are in medical advantage, which bears both the medical Part A and Part -- Part A and Part B and the pharmacy costs in Part D. So the payer is clearly aligned to treat these patients better to keep them from being in the hospital. The hospital is aligned as well. The average length of stay, it's 5.2 days. The DRG only reimbursing 3.9 days. We also know that these hospitals are responding to these readmission penalties by trying to hold the patients longer. So they're now in 6, 7 days, losing money on every patient and still 25% of them are bouncing back. The plans are responding by cutting the payment for a readmitted patient in half. So now the hospital is losing patients -- losing dollars on almost every patient for heart failure. And for some of them, it's a multimillion dollar loss on patient care for heart failure. They want full bed but they want full beds of total knee replacement, total hip replacements. So we know the payroll is aligned. We know the hospital is aligned, we know the doctors, the doctor -- as Dan showed you, is trying to prevent these patients from getting so sick that they permanently damage their heart and is then exposed to the hospital. They know these patients are their most vulnerable patients. And now we see that the hospitals and the plans are giving actual penalties to the physicians that might own the physicians for some of these heart failure readmissions. But how about the patient? Let's talk about the patient. So the patient -- it's the heart failure patients. They're probably not out in the World Cup skiing, but they want to be at home. They want to be with their family, their friends, their pets, but be at home, not be in the hospital for 5 days and then be back readmitted. In fact, on the next slide, we talked it. We talked to patients. We ask patients a bunch questions. The first thing we said is in the current landscape, how are you being treated? Is this being treated by PCP? Are we going to have to target, and I'm going to start talking launch here. Are we going to target PCPs? We don't have to, 93% of these patients are managed by either heart failure specialists or cardiologists that has a focus in heart failure. In fact, 70% of them are just a heart failure specialist. So it really gives us a targeted call ones for our sales force. So we know they're managed by cardiologists. We also know that these patients are obvious for the doctors. Patients know they have heart failure. Doctors know that they have heart failure. They've been hospitalized. They have a resistant episode to an oral diuretic. So we don't have -- it's not overactive bladder where you need to go out and educate patients that they have this disease. They know they have it. They're obvious. All of them have been hospitalized. So we asked them, what do you do now if you have worsening symptoms? Do you call your doctor, even though you probably end up in the hospital before. Yes, 71% do, even before they go to the ER in hospital, they're going to call their physician to see if there's something else they can do to prevent that hospitalization. Dr. Bensimhon talked about doubling the doses. That's what's happening out there. 80% of them have doubled their doses prior of the oral diuretic prior to having go to the hospital. We then said, okay, that's what's happening now. Let's show them a target product profile of FUROSCIX. And simply, we showed them the infuser, talk to them about how it works, showed them how to wear it and said, "If this was approved, if this available, would you actually talk to your HCP sooner? Your cardiologists or heart failure specialist, sooner about your symptoms?" We already know that 71% of them are hauling prior with 91% of all the patients, not a subset of the 71%, 91% of 100% of these patients said they call their doctor sooner about their symptoms. Again, as Dan showed you a chance to intervene before they need to be so sick, they need to be hospitalized. We also said we would be likely to use this, if your doctor prescribed this in front of going to the ER in the hospital and 90%, 90% said yes. So 91% going to call the doctor earlier now. So the doctor can intervene and 90% said yes, yes, I've used it. And this is before we train them on it or give them all the support mechanisms to approve them. We then went a little to a different angle and said, "Boy, with COVID, are you now comfortable with telemedicine visits?" So actually calling a doctor, talking about your signs and symptoms, maybe showing them an ankle or a finger, which is swollen, 59%, 60% said very comfortable. So think of the day, and I know Dr. Bensimhon has talked about kind of the hospital at home, where these patients can call their doctors do a FaceTime, talk about their symptoms, talk about their weight and actually get prescribed over the phone, FUROSCIX and then we'll deliver it through our specialty pharmacy to that day or the next day. So that patient, maybe an hour away, 1.5 hours away, that patient terrified with COVID, now doesn't have to leave the home it can get effected, 100% bioavailable heart failure treatment at home without having to go to a clinic, doctor's office or a hospital. Next slide, please. We talk about these readmissions...

John, I hate to interrupt you there. I just want to say one thing. Networks of care are already being designed around that workflow. Brigham and Women's Hospital yesterday announced a huge hospital at home push to deal with this problem. And there are national cardiology networks that are being delivered now -- created now to deal with heart failure at home with better monitoring devices and better therapies based around exactly of what you just discussed. So the industry is waiting for this and expecting these advances so that we can treat these patients at home. So I'm sorry to interrupt you, but you really -- that telehealth is a very, very important piece of what we're doing now.

Thanks, Dan. This next slide talks really focuses a little bit on this readmission -- no, I'm sorry, can you go back one slide, talks about the real problem and readmission. Looking at congestion and discharge, really, you have about 84% of the patients that still have residual fluid at discharge, 52% of them with really high grade and then another 32% with low grade. So we know they're congested. But we also know they come back to their post-discharge appointment. On the right, you'll see a graph that looks at what percentage of these patients are coming back within 10 days for their post-discharge appointment. Over 80%. This has been an initiative that the hospitals have taken, taken charge of to make sure that we're following up with these patients. So the next time we see them, it's not just because they're being readmitted. So this is the opportunity. You have 52% with serious edema, they're all coming back to -- or 80% of them are coming back to see the doctor, right there an opportunity for that doctor to aggressively intervene and give them 100% bioavailable Furosemide and give it to them without them having to be readmitted to the hospital. So that's the patient. So let's talk about the doctors and the doctors are going to use this. So in the next slide, we actually show the target product profile. This is our target physicians, heart failure specialists, cardiologists, nurse practitioners. No secret here, 93% to 96% of them said they use FUROSCIX. They've been using 100% bioavailable Furosemide in their entire careers. They've got to use it in the hospital. Now we're giving them a chance to get it to patients really where they want to give it to them and when they want you before they get so sick that they have to be hospitalized. The key thing in the launch is how quick will they use it? We saw 86% to 89% of these doctors would use this within 6 months. With typical launch is you have payers putting up hurdles, you have to educate patients that they have a disease or educate the physicians what the disease is, or then have doctors that say, "Boy, I'll try on one patient and wait 6 months and see how they do or I'll wait for the KOL up the street to tell me that it's safe to use it." We don't have that here. We have doctors that have used 100% bioavailable Furosemide, their entire career and this is a new way to get it to the same patient they've been treating. The exact same patient that they've given orals, they've doubled the orals, they've admitted, they've tried IV in the clinic. The same patients, same physicians now able to prescribe that 100% bioavailable at home. So we know the doctors are going to use it. The question then becomes, how often are they going to use it? And the next slide, we actually asked the docs, look at your last 2 patients. Look at those patients that here it's called clinic based. These are those patients that come in, the first signs of congestion, swelling, a little bit overweight, but before they need to be hospitalized. The doctor said they give it to 2/3 of their patients, 2/3 of those patients, then we said, okay, those patients that have been recently discharged, what percent of those would you give FUROSCIX to, and they said 46%. So when I showed that chart that showed a $6 billion market opportunity and said for, we only need 17% to get to $1 billion. You can cut this data any way you want. And I would argue, we've double cut it. because we know when we ask these doctors that someone said to me once, why isn't that 100%? Because the doctors know there are some patients that they have that are noncompliant that might have some level, as I mentioned, it doesn't live with a caregiver. So we've actually already took in that hair cut. And then when we look to the right, and our launch focus will be 100% focused on heart failure specialists, heart failure nurse practitioners and those cardiologists that treat heart failure patients. We know in the future, there's an opportunity ER when these patients present. We know half of these patients don't need to be hospitalized. And we've proven in freedom that we can treat those patients safely and send them home and not have them admitted even before we detail to these docs, about 40% of the ER docs would use this drug, not a focus at launch, but clearly an opportunity to expand the market. So the next slide. How do we look at segmenting the patients which then allows you to segment and target the doctors? Our patients are Class 2 and 3 heart failure patients in New York Heart Association 2 and 3 heart failure patients that are on an oral diuretic. We don't anticipate any patient coming to FUROSCIX that's been naive on an oral diuretic. And again, there's 2 buckets. Those are recently discharged or recently hospitalized due to fluid overload, that no longer need hospitalization but do need enhanced diuretic. And then those patients, I call these the pre-symptomatic -- or the preadmission patients, patients presenting with signs and symptoms of congestion and reduced responsiveness. Those are our 2 buckets. Post-discharge pre-admission. Who are the doctors? These are the doctors that care for these patients. They're heart failure specialists. They're heart failure nurse practitioners, and I think Dr. Bensimhon talked a lot about their role. It's a critical role. A lot of nurse practitioners even in heart failure really are managing the diuretics. So we're really targeting these nurse practitioners. Obviously, select cardiologists that care for heart failure with their patients and then eventually the next tier of the emergency in that. Where are these doctors? How are we going to get to these doctors? They're an outpatient heart failure clinic, sometimes in the hospital, sometimes outside the hospital. And then they're in hospital-owned cardiology, heart failure practices. This is not a hospital drug that has to get on formulary. This is an outpatient drug. So here's where we're going to target these physicians. Who's the patient, or how are the patient, how we're going to introduce the patients to the drug. It'll be during a scheduled heart failure clinic as part of routine monitoring that these patients have all the time. These are heart failure patients with their physician. Maybe it's not a patient initiating kind of worsening fluid symptom, heart failure visit to the physician or maybe it's at the hospital. They're having an off state in the ER or they're in the ER, they've been stabilized, maybe even with an IV dose and the ER doc with a consult from cardiology realizes this is a patient to go home, who can go home, who can use FUROSCIX. And then, as I mentioned, on those follow-up visits 3 to 10 days at the hospitalization. So there's how we're targeting the patients and the physicians. The successful launches. We have reimbursement lined up. You have physicians that understand how the product is used, understand how to use it. But can you get to the physicians. And in the next slide, you'll see this is a pre-targeted launch. You don't need 800 reps to get into primary care. We can call on about 6,000 physicians, nurse practitioner and heart failure specialists that represent anywhere from 40% to 50% of the opportunity with 40 reps. 40 reps gets us almost half of the opportunity. And these are -- this is obviously the highest decile doctors that are affiliated with the highest decile doctors defined by hospital admissions and discharges. 40 reps cost us $12 million. Yes, eventually, we'll expand that to probably about 125 reps. But you're not going to need an 800-person sales force to market this product. We can do it to launch with 40 and grow over time to 125. On the next slide, so how are we going to market it? How are we going to support sales forces out there? How are we going to support the white space where we don't have a rep? How are we going to support any of those offices that sort of COVID for whatever reason are kind of no-see offices. We'll use an omnichannel marketing approach, both for personal and non-personal tactics. What we're trying to do, what every brand tries to do, drive brand recognition, adoption and commitment with a print and electrical -- electronic collateral. Our sales reps will be doing in services at hospitals, in heart failure clinics, in doctors' offices, wherever we need to educate someone on the use of FUROSCIX, how to use the infuser, the role of it, how to target patients will do that. We'll have patient support and education tools, both directly and doctors' offices and through our hub. We'll have demo kits in every doctor's offices that allow the nurses and the doctors to walk the patients through how to use it and why to use it. We'll have patient websites. We'll have physician and nurse websites. We'll be at all the presences. We'll have a media strategy. We'll have digital campaigns we've already rolled out, speakers bureaus. We've already also engaging with our MSLs, KOLs, key opinion leaders. We're talking to them now. We're continuing to develop new ones. So it's a complete marketing approach to support the direct effort of our sales force and a nondirect effort to target at first, physicians and nurse practitioners and nurses, and then we'll expand that target patients. Again, not a disease awareness, more targeted patient and caregiver outreach. The next slide really shows kind of the first execution of this. We've chosen a coming soon campaign. And if you know in pharmaceuticals, you have the option. You can do a disease awareness campaign or a coming-soon campaign for pretty clear reasons, we chose the coming-soon campaign. You don't need disease awareness to physicians around heart failure. They know what it is, and they know who their patients are. And you don't have to do that with patients either. What we want to do is facilitate a quick launch. And by doing that, we decided to do a coming soon campaign, really to drive awareness and frequency of the name. We think FUROSCIX a great name, conditionally approved by the FDA and the F-U-R-O stands for the generic name, Furosemide. The S-C stands for subcutaneous and the I-X is the end of LASIX. We show this to docs and nurses. They know what it is up. This is subcutaneous LASIX or subcutaneous Furosemide. They know it. So our goal is to get this name out with a coming-soon campaign as soon as we can. We've already rolled it out. We pretty much own the American Association of Heart Failure Nurses meeting. We had booth up. We had banners, we sponsored the program. We -- so it was a digital campaign as well. We'll also go in journals, in August and September will be the Journal of Cardiac Failure. Phase 3 will be at the Heart Failure Society of America conference, where, again, we'll have booths, we'll have banner ads, we'll have support the conference, support the agenda. So our goal with this campaign is really to increase the awareness and then the frequency of the name FUROSCIX, really preparing for the launch. Next, next slide. To talk about the payers, we understand, and I think you did a great job talking about how the payers look at this. This is the Medicare Part D drug, about 75% of our lines. We know this market is moving aggressively towards advantage plans, which really fits the model of what FUROSCIX will do, what FUROSCIX really does is drive down the cost of heart failure up-care and we know this trend is going to continue. We also know that a lot of these patients are already in what we call dual eligible medi-medi, and we'll have fixed low-tier co-pays right off the back. But the goal of our managed care strategy is to drive patient co-pays to a fixed tier co-pay, enabling patients to be able to access the drug at a low cost. In the next slide, we really look at the super targeting. So again, when you think about a launch, you think about what's successful on a launch, having your stakeholders aligned, then doctors understand what the product does, and who it does, what it does for and the doctors understand the disease, having patients motivated to get treatment and having a great HEOR story. But it's tough if you have your payers spread out all over. Not in Medicare Part D, this is concentrated. There's 7 payers who's at 86%. 86% of all the Medicare Part D lives sit in 7 payers. It's incredibly, incredibly targeted. We've spoken to all of these plans in the last 12 months and a pending appointments as we single one of them as we go through the end of the year through approval and into commercialization. So we've already spoken to these people. We will continue to dialogue with them and have additional follow-up deployment. Our goal really is to have formulary acceptance on all of these plans shortly after launch. If we go to the next slide. So we talk to these plans. Of those 7 plans, 6 of them, we're involved in this market research that we just completed. And we said to them, give us your overall response to the value proposition that FUROSCIX get. It was either universally positive or more of them were very positive to the message. And these people are usually very skeptical on a drug. We ask them to really understand the unmet need. And heart failure patients are the most expensive patients, they were most of their initiatives or more than any other drug category, most where initiatives are, so they really understood the unmet need and the cost of heart burden, and really the heart failure and the burden for their entire organization. What's important to us, even though Dr. Bensimhon showed us these patients progress rather slowly, days and weeks, not hours, it was really important that these respondents, these are payers understood the need for the rapid delivery of therapy. And they understand that they can't put -- they believe in the value prop, they can't then turn around and put these controls on that, keep the product from being able to get to patients quickly to help them. Control idea is to reduce the cost of hospitalization. So if you ask me on this market research, what is the most important thing. I think it was that control that they understand they're going to have to provide quick access so these patients can benefit from the treatment. We then talk to them about pricing. They were surprised, and we showed them the price, and we used the $700 to $800 range. They thought that they were pleasantly surprised that it wasn't more. Again, if you look at the cost of the hospitalization from 12 to 20, and we're looking $12,000 to $20,000 and we're looking at anywhere from $2,800 to $3,200 to replace that cost. They were very surprised and thought that was the right range. Does it give us upside potentially, we haven't made our final pricing decision. But I think this input really gives us confidence that we're in the right range and might have a little bit of room. So that's how we're looking at the payers. So how are we going to distribute this? And how are we going to support the patients. So in the next slide, we really look at our distribution and patient support. We're going to use a 3PL Cardinal, a third-party logistics company. We're going to distribute that directly to 2 national specialty pharmacies. So the drug will be shipped right from the specialty pharmacy to the patient's home. We'll also offer samples in the physician's office in the heart failure clinics where accepted, for the patient will provide training, live support from our hub, we're going to use a patient support hub. We'll have online videos. We have instructions for use in the package with FUROSCIX. We'll have home nursing support if needed. We'll have reimbursement support for the patients, we'll have a patient assist program. We're going to wrap the patient. So we'll have demo units for the patient in the doctor's office. We'll have in-service all of those nurses on how to diagnose the patient and how more importantly, to use the infuser incredibly simple. We've done a lot of human factors top learn. But we'll then support that patient with an instruction for use in the box, instruction views online, live support from the hub, will have FaceTime support from the hub or home nurses if they need something, will also support them reimbursement. So really, when you look at aligning the physician, payer, the patient, and the hospital. We think this really is a unique opportunity in a really, really good market. So -- that's why that's my last slide. So if we want to open it up for questions, that would be great.

Absolutely. Thank you, John. [Operator Instructions] So our first question is from Douglas Tsao from H.C. Wainwright.

First question maybe for Dr. Bensimhon. I'm just curious what some of your key takeaways were from the at-home data that was released yesterday. And I'm just curious, the 37% reduction in hospitalization, was that sort of consistent with what your expectations are and what you would expect to see in a real-world set?

Yes, thanks. Great question. So as for people who know the Home trial was designed by Jim Udelson and team at Tufts. And what they did is they tried to do the same thing that we did with FREEDOM and but they moved it to the clinic setting. So they took patients who are presenting to the clinic and these were heart failure clinics. So this is just not your average clinic. So these are heart failure patients and heart failure clinics that are very skilled in treating these patients with early decompensation. They took -- I think it was 51 patients. And what they did is randomize them to FUROSCIX versus usual care. So what we usually do for these patients. And what you saw, as you pointed out, was a 37% reduction in heart failure hospitalization over 30 days. I think this is a home run. And there are some other end points there that was important. But I think this goes back to the point, 40% of people in the best of hands in Udelson's, in the clinics in Tufts, in our clinic, 40% of people who came to the clinic saying, I'm short of breath, we couldn't -- 40%, we couldn't manage effectively. They ended up getting admitted because we couldn't manage effectively with the tools we currently have in our toolbox. So that's the one thing. The second thing, every marker of decongestion went down. So if you looked at BNPs, if you looked at orthopnea scores, if you look, there's a 5 pound decrease in weight compared to usual care, every single marker, in my mind, this was the mechanistic study of how this works, right? It relieves congestion, it does so effectively at a fairly advanced stage of decongestion when the patients headed to the hospital. Then I think John Tucker did a wonderful job of bringing it back to the patient, right? If you look at 30 days, the 6-minute walk approved -- improved 50 meters. Drugs get FDA approval by improving 6-minute walk by 15 meters. And several doses of this drug took it up 50 meters. I mean it's just incredible what that does to a patient's functional status with heart failure. So in my mind, it's an absolute home run for. But for people who've used it, we've expected this. I mean this is not -- this is a no-brainer. This is a drug we know how to use. This is -- we're just missing the delivery system in our toolbox. So -- and then finally, you look at KCCQ scores, Kansas City Cardiomyopathy scores. There's a 12-point decrease in KCCQ, which is exactly what we saw in the FREEDOM HF trial. Anything more than 10 is really is called as a moderate to large effect. So consistency, consistency, consistency. It's about congestion, it's about having the right tools to deal with it at the end of the day once you give us the right tools, we're going to save you a lot of money.

And maybe as a follow-up to that, I mean, were there -- within the secondary endpoints, were there any that really stood out to you or you place greater importance on?

Yes. I mean I think the overwhelming thing was the consistency, right? Every single marker we looked at was consistent -- I mean, a 50-meter change in 6-minute walk is just unheard of. And then if you look at a 5-pound weight loss in patients in just a couple of days in patients who are fairly advanced. I think they're all important. Obviously, I think the 6-minute walk really stands out. But it's hard to argue with a few doses of medicines leading to almost a 40% reduction in hospitalizations, right? How do you beat that, right? And this is 50 patients. This is not -- this works if it's amazing. The people who have used this drug are overwhelmed by just finally having the tool that we've been waiting for.

Great. That's really helpful. And just maybe as a follow-up to Jim Kenney and even John Tucker, if he wants to chime in. Obviously, it sounds like payers will be supportive of the product in the early going. At the same time, it's usually sort of part of their nature to put some types of restrictions on utilization. Do you have a sense of how they're being about incorporating this into their sort of allowed treatment algorithms for a lack of a better phrase?

Well, I'll start. I think the issue here is, as I mentioned earlier, every company says, well, we offer some medical cost to offset on the product, right? But in this case, it's so significant that the payers are going to find that to be very, very compelling. It's a drug we're familiar with, right? So we don't have to think about, we're not sure about the drug. Do we have to worry about safety and tolerability and things like that. The distribution is through major specialty channels, so that makes it easier as well. So I think that economic story is very compelling. We're buried in specialty drugs today and specialty drugs never provide an offset in terms of medical cost. And this is a familiar drug. It's a huge population. And as John mentioned, that Medicare Advantage population is huge at 50%, and they have risk, right? They've got risk for this population. They are the ones that are being paid premiums, if you will, to cover these patients. But at risk. So I think the financial story is really very compelling. And that FREEDOM HF slide that Dr. Bensimhon presented was really literally and figure ably the money slide, right? And it really showed you in real numbers that significant difference between what's the cost of the drug going to be and what's the overall net savings to the plan, not only with the initial admission, but potentially with the readmissions. Again, if they've got a contract that only covers 50% still on the hook for that. So there's huge savings potential, and we rarely see that with a drug.

The other thing I would say one thing, there's instant gratification for the patients and the providers in using this drug. Patients feel better instantly providers see at work. There's instant gratification and reinforcement of this is it. And it's not like you have a cholesterol medicine really, there's a 35% reduction in cardiac events over 3 years. Patient gets muscle aches, they don't like it. They don't want to take it. It's hard to get people motivated this. But in the study, we had people who use it and they said, "Can you give me that thing again " that is the kind of things that you hear from people. I never was that dry in clinic before. These are the kind of things you hear from people who have been exposed to this product. Steve, do you have anything to add on the payer?

Yes. We've had a chance over a couple of years to talk to so many of these payers, VPs of pharmacy and medical directors at plans. They're all extremely rational about the use of this product. They like the idea that it will be used after other things that are on formulary have failed. There's a reduced responsiveness to oral diuretics and so that gives them comfort that it wouldn't be used in appropriately. They all acknowledge that these patients need to get on therapy. After these other treatments have failed, they need to get on therapy fairly quickly, so they don't want to put extreme controls in place. Some have talked about no prior authorization at all. Others have talked about minimal prior auth like a diagnosis of heart failure treatment by a specialist maybe a history at some point of a heart failure hospitalization, but not difficult things. So the fact that the patients will get immediate benefit and they'll go right back on the chronic generic maintenance meds, makes sense to all of them.

Any other questions?

Sorry that -- thank you so much -- that's really helpful.

Our next question comes from Nik Gasic from SVB Securities.

This is Nik Gasic on for Roanna Ruiz. Maybe just a question for the general management team. Maybe like how can you drive awareness for FUROSCIX among the physicians who may continue to prefer, have more control over diuretic titration and patient monitoring? I'm just curious how you're thinking about that.

I'll address that. Good question. So it's not separate. So we have a lot of patients, obviously, the rise of CardioMEMS. We have currently in our clinic, we have 3,000 patients and about 500 of those patients are in chronic monitoring programs either through their ICM device with defibrillators, CardioMEMS or we have some at home sensors that we've been using that are noninvasive sensors that are really growing in popularity. And we realize so we're allowed to see when the fluid goes up. And what you realize is that now you're able to detect when those patients are no longer responding. So we say, okay, we doubled the LASIX. We see no response. And now we're kind of stuck. So what we would do in this patient population is hopefully, you would have the patient who are in these programs would have several of these doses at home. We would say, Hey, get them out of the refrigerator wherever you're going to keep them, give yourself 2 or 3 doses. Get back on track, reset yourself? And then you just go right back to where you were. So it allows us immediate control. So it really increases our ability to fill that gap. Previously is that if we double their LASIX and they don't respond, we either tell them to go to the ER, we bring them in. One of the earliest trials with OptiVol when they used OptiVol, these remote sensors, the first trial in Israel showed that they detected a lot more fluid overload, they doubled hospitalizations because the physicians said they're fluid overload, we can't do anything about them and send them to the ER. So I just think it gives us a tool in that scope of tools to just be more effective at what we do. Does that address your question, Nik. I hope I got it.

Yes. Yes, definitely. Maybe just a follow-up on that front. I think John mentioned roughly 4 units per course that you're targeting. I'm just curious, like is there a chance that a potentially higher dose cartridge could help reduce the number of units needed to treat these patients?

Yes. So LASIX is a threshold drug, right? So you have to get to a certain level to get people to diurese and it's the area under the curve, right? So once they start diuresing they tend to do pretty well. You're right in a select group of patients. There's some patients actually need more a higher dose to get them going. But for the majority of patients, this dose works really well. And for the patients sometimes -- and there are going to be options, I think, down the road to give higher doses and things like that, we're going to be doing. But for now, I would -- 80 milligrams of IV LASIX once or twice a day is going to address my needs for 90% of my patient population that's going to need this. if I need 120 or 160, if I still have to bring in the clinic or do something to get them started, I'll do it. And as we as this drug gains acceptance or we're using it as the higher doses come out, then we'll fold those into it. But if you told me you were going to wait on 80 milligrams until you have the other doses, I'd be up in arms, like what the, what are you thinking? You've solved almost all of my problem, don't go back.

Got it. And then maybe one more from us on the commercial side of things. Could you talk a bit more about your outlook on partnerships or co-promote agreements for FUROSCIX and maybe like to the extent -- like what -- to what extent could this expand reach throughout the U.S. down the line?

Steve, do you want to take that question?

Yes. I mean we're always open to opportunities to partner. We don't shut that thinking down. But we really think with the team that we'll put out there initially, which will be a national team. We will hit all the big centers, all the hospitals with the most heart failure hospitalizations, discharges and those docs that we could reach, as John said, 45%, 50%. With proof-of-concept, which we think we'll find, it will be pretty easy for us to scale 20 more reps, 40 more reps, they can do that. There may be a point where it makes sense to partner, to expand reach into those lower decile physicians and hospitals, and we'll be completely open to do that. But right now, we feel like we're very confident that we can do this ourselves and do it well.

There's a group of us that have been working on a very large heart failure telehealth network to span the country and to help provide heart failure care to people in remote areas. And there's -- I'll just tell you, among this group there's a huge interest in how do we escalate diuretic dosing in patients who don't have access -- easy access to clinics and things like this. So there are huge opportunities in the telehealth space that are waiting for products like this to address levels of care. So Obviously, I'm not a business guy. I'm a heart failure guy, but I'll tell you, when you're talking about systems of care, I've been very involved in these national discussions, and this is something where there's a huge amount of interest, not only on the clinician side, but on the payer side as far as how do we provide value-based care for heart failure patients because they're spending a lot of our money.

This concludes the verbal portion of our question-and-answer session. I'll now turn it over to Hans Vitzthum from LifeSci Advisors to read the remainder of the questions.

And we do have a couple of questions that have come in from the field. The first question goes to human factors, but many of these patients are elderly and infirm. And will the device be simple and easy enough for those patients to understand and utilize the device? And is this -- where does this fit sort of the FDA's review considerations. So it's probably a 2-part question. Obviously, Dr. Bensimhon, this is would love your input on this, but also, I think, a company's perspective as well.

Sure. Let me -- I'll take the start of it, and then Dan can talk about it. So heart patients. So when we were developing the device and the size of the device just into account kind of their daily living and their activities at their learning to make sure this wasn't interrupting with their activities in daily life. And it doesn't. The only thing they really can't do with it swim or take a shower when they're wearing it. And I think you need to compare the restrictions on activities that they are living when they're wearing a small iPhone like device versus laying in a hospital bed for 4 or 5 days and how that impacts their ADLs because that's really the comparison. And keep in mind that 50% of these patients do have caregivers. But I'll let John you talk a little bit about the work we did on human factors to see if it's usable.

Sure. So I'll discuss the human factor. So we did conduct a complete human factors program. Obviously, that's required for approval of a drug device combination for CDRH. We spent a lot of time designing the instructions for use testing that, conducted some formative studies that ultimately culminated with a final validation study that we conducted in 60 participants. We did at 30 heart failure patients where half of those heart failure patients were trained, then went home and came back 24 hours. So we had a 24-hour decay in between the training and when they actually perform the tasks and then the other 15 heart failure patients were untrained and we had been perform the tests there. We also looked at 15 heart failure nurses and 15 caregivers of heart failure patients, all of which were untrained. So 75% of the participants were untrained, the other 25% had a 24-hour decay. We looked at over 17 use tasks and whether patients -- watch the patients, did they perform any of those used tasks incorrectly that could result in potential harm. We're over -- we think the 60 participants time to 70 use tests over 900 data points. We're over 99% successful in those use tasks. Wherever you couldn't actually watch the subject to do it. We had knowledge test where they had to answer questions based upon their understanding and interpretation of the instructions for use, 34 of those, thousands of data points and again, 99%. But most importantly, there were no trends towards the same mistake happening over and over again, that would potentially lead to harm. This protocol -- final protocol was reviewed by the FDA, they provided us input on that. They've also provided us insights on the instructions for use. So we feel confident and this is obviously a part of our NDA, but we feel confident that we provide a human factors program that would be sufficient for the FDA to make a determination on the appropriate use of the device. I'll take a comment on age. The average age. We had some nurses, heart failure patients. But I can tell you in our studies, that we had the average age of the patients within our studies about 65 years old. We had patients as old as 80 that were enrolled in our clinical trials as well. We believe that the age of the patients that we include in the human factors as well as what we've seen in the -- in our clinical trials is representative of heart failure patients and individuals that may have issues with it and we didn't observe any of those in any of our studies.

Dr. Dan, maybe?

Yes. I mean I think we ourselves and the guys in the University of Minnesota and Jim Udelson and his team at Tufts have probably had the most clinical experience with this. And -- it's straightforward. It's easy to use. We really haven't had -- this is a device that's been in the space -- the cardiology space for a long time using Repatha, nurses are comfortable educating these patients. It's -- it really -- we really haven't had a problem. We -- the first time they come in, we show them how to use it. We have a group of home health nurses in case people really have problems to go out there and help them. But that really hasn't been necessary. It's been -- in the clinical trial has been very straightforward to use in clinical trials really. I have no concerns about the -- what's the trade-off, right? You come to the clinic and you have to park and you got to do all this or you come 3 days in a row or you go to the ER. What's the trade-off wearing a little thing on your thing? It's just -- it's almost a no-brainer. So no, but no major concerns about the device that we're pretty comfortable with.

That's great. Now I'm going to try to paraphrase this question and I think this is targeted to you, Dr. Bensimhon. But -- and the question really speaks to whether or not when using FUROSCIX, if there are any special considerations in aggressive diuresis in terms of managing hypertension and kidney and electrolyte management? Is there anything that requires a different sort of approach?

Yes. So this is what we spend almost all our time doing in heart failure clinics, right? And I will -- I'll turn the question around on you. So the biggest risk is not being effective, right? The biggest risk is that you don't get the fluid off and the patient comes to the hospital. So that's number one, the biggest risk. The second biggest risk is one of our go-to products to date is a thiazide diuretic called Metolazone, Metolazone is an effect of oral diuretic it potentiates the effect of LASIX. Unfortunately, it is really associated with severe electrolyte abnormalities, hyponatremia, hypokalemia, it's -- I probably have a patient every other month that gets shocked from their defibrillator because I've used Metolazone and depleted their potassium too much. So there are up and down side all over. But the question is really asking about can you over diurese a patient? Can you take too much fluid off? And the answer is yes, you can take too much fluid off. It can happen with any form of diuresis. And -- but this is what we do day-to-day, right? We give a patient a dose of a diuretic or 2, and then we follow back up with them. Are you getting better? And we know from our clinical experience and from the clinical trials, the sweet spot is about 4 doses, right? And it really jives with what we do in the hospital when patients come in. We do about 4 doses. And we talk about this telehealth heart failure network. Well, the one thing we didn't talk about in the telehealth heart failure network, the telehealth heart failure network comes with a blood pressure cuff and it comes with home labs. So we're checking labs every day. We're checking blood pressures every day. We are building a system around this to treat heart failure patients at home. The pieces we're missing right now are a device that makes people pee reliably at home. And so when we talk about missing pieces, we're assembling all of these pieces together. And we're just out here waiting for all the pieces to come together and the FDA to kind of say, yes, yes, yes. And in next year, people will be talking about heart failure, the way they do about diabetes. This is closed loop therapy. You have a device to measure fluid, you have a therapy that works very well. You have a device that measures electrolytes and makes it sure that's okay, and you have a doctor who's willing to manage it remotely and those patients never have to come to the heart failure, whether they're in Greensboro, North Carolina, Manhattan, or they're in Iowa City, right? We can manage them all the same. And this is the Holy Grail of heart failure management. You're witnessing the change in what we do. Right now, and it could never be more in flux. So we are very, very excited in the heart failure world. All these medically home things in heart failure at home, this is what it's about.

That's terrific. Dr. Bensimhon. We have -- and this is a question, I think, for the company. But the first question, and there's 2 parts to it that is, can you speak to the IP estate for company for -- excuse me, for FUROSCIX? And the second part of the question is, can you speak to ex U.S. launch plans?

So I can take both of those. So our IP on the drug formulation and method of use is to 2034 on the drug component. West has a portfolio of patents around the infuser, probably the nearest term is a 2035 patent. So 2034 on the drug, '35 on the device. Keep in mind as a drug-device combo. There's only been a couple of ANDAs at [ Vidiscous ], EpiPen, both long after patents that expire and both still have about 60% market share. Your typical generic company and Dr. Reddy's is going to be able or willing to make a device such as the West device, which is a smart device or the biphasic dose along with notification. So we think the IP is great at '34 and '35 but there's also functional barriers to entry after that. As far as ex U.S., we have ex U.S. rights. Obviously, Europe is a place we're looking. I don't think we do Europe ourselves. We definitely look for a paying European partner to license the drug too and then for them to finish whatever regulatory work needs to be done in Europe and then to have the European markets. We look for a similar partner in the Asian markets. We think, obviously, Japan, South Korea, China is a big market, a little difficult to manage right now. But we think Europe and in some of those bigger markets in Asia would be where we would license the drug next.

That's great. Thank you, John. We are at the 90-minute mark. So I think I will turn it back again to you, John, for closing remarks.

Great. Thanks, Hans. And thanks, docs. I want to thank Dr. Bensimhon. Thanks, Jim Kenney. Really appreciate it, and thank everyone for listening. We're really an exciting inflection point for the company and look forward to the next 3 months and the launch. So thank you, everybody, and have a great day.