We'll get started. I'm Doug Sow, Senior Analyst for DHC Wayne. Up next, we have scPharmaceuticals, represented by the company's CEO, John Tucker. With that, we will sort of jump right in. My first question is, John, do you think the Celtics are still going to win in six? I might have been wrong about that, right? We lost Tatum, so. I think it's always helpful if you can just provide a quick overview of the company and your commercial product and what the unmet medical need that it solves. Sure. Thanks. And Doug, thanks for allowing us to present. So scPharmaceuticals, I think the name says a lot of what we do. We've really been focused on delivering drugs that are proven safe and effective, but are delivered in the highest cost setting of care, the hospital, with the worst patient outcomes, the hospital. But they're trying to create novel deliveries to drive that care out of that high-cost setting of care into the lowest-cost setting of care where the best outcome's in, which is the patient's home. Our first product, FUROSCIX, is 100% bioavailable furosemide delivered through an on-body patch pump that the patient wears. The patient can wear this at home, do anything they want to do. They're heart failure patients, and so they're probably not out running marathons, but they want to be home with their family, their friends, their neighbors, their pets. Our technology and our product allows them to do it. The unmet need is simply this: we have 6.5 million patients in the United States with heart failure. Four million times these patients annually will have a worsening heart failure event. It's not every patient. It's probably about 1 million to 1.2 million of them will have a worsening heart failure event where the oral Lasix, the oral diuretic they're on, just stops working. Its bioavailability goes down to as low as 10%. This patient is taking on fluid. The diuretic, which is supposed to manage their fluid, can't keep up. Its bioavailability goes down to about 10%. The patient's getting worse and worse. Diuretic's not working. Patient's putting on fluid, can't get out of bed, can't walk up the stairs. That patient will inevitably end up in a hospital. What we've done is been able to deliver 100% bioavailable furosemide, equivalent to the IV they get in the hospital, but allow them to do it at home to prevent that need for a hospitalization, to intervene earlier when that patient first starts struggling. There's no need anymore for patients to be sitting home for two or three weeks hoping that oral eventually works. Can't get out of bed, can't get up the stairs, can't go get the mail. That's what we're doing. I think one of the things that you sort of have two settings of use, I think. I think one of the early focuses was on sort of, as you described, to prevent a patient from being hospitalized. I think that there has also seen some adoption in terms of, as a patient is discharged, right, shortening the length of stay. How do you see the balance between use, right, between preventing a patient from going into the hospital at all or reducing the length of stay and preventing that patient from coming back to the hospital? We kind of look at it a little differently now. We're looking at a kind of a pre-IV patient, post-IV patient. We really want to catch this patient when they first start failing on the oral diuretic. You'll have days, maybe a couple of weeks, to intervene right there. Don't let this patient get so sick that they have to be hospitalized. We know every time a patient's hospitalized for heart failure, for fluid overload, that they're going to have worse and worse outcomes. The next hospitalization is closer. Eventually, death is closer. We need to intervene early, right when that patient first notices they're a couple pounds over their dry weight. These patients all know their dry weight. Or when they can't get their slipper on because they're having swelling in their foot, walk up the stairs, they're short of breath. Uh-oh, it's happening again. Call that doctor right then. Intervene with FUROSCIX. We're not going to get every patient. Some patients are going to wait too long. They hate going to the hospital. These are heart failure patients. They have horrible outcomes. No sequelae of infections, COVID. These patients go in. It's a bad experience for them. We're not going to catch all of them, though. Some of them are going to end up in the hospital. We have a couple of different opportunities to intervene with that patient. They get in the hospital. You're absolutely right. They're in for two days. They're stable. They just need to finish the job. They need to finish the diuretic job. They can finish that at home. Discharge them at day two, give them three or four days of FUROSCIX, and they'll clear their fluid overload. These patients are in the hospital now over five days. Five days just to get an IV diuretic that they can now get at home. It doesn't make any sense. There's also the opportunity when that patient's discharged. We know 50% of these patients are discharged "wet," where they have residual congestion. Why does that happen? It doesn't happen in Germany. Germany, they keep them in the hospital for 12-15 days. Why? They don't want patients bouncing back. The United States, you just can't do that. You can't tie up a hospital bed for 12 days for a simple congestion patient. There is pressure on the physicians. Get the patients out of the hospital early. You do that, they have a tendency to bounce back. FUROSCIX is perfect. Patients have been discharged. Let's say day two. Let's say day five. Let's say day six. They're discharged, come for their post-discharge visit, residual congestion. Right there, intervene aggressively. Get FUROSCIX. Keep them from bouncing back into the hospital. CMS recognizes this problem. In fact, they institute a hospital readmission reduction program to penalize hospitals for excess readmissions. FUROSCIX is the best tool. Keep them out. If they do get in, get them out quicker or keep them from bouncing back. I'm curious, do you see in hospitals that have worse readmission data, right, higher rates of readmissions, are you seeing them embrace FUROSCIX, or is there still a bit of an education that you need to get them to understand the value that FUROSCIX can provide them? There's a lot of education at the hospital. You have the rank-and-file cardiologists who are admitting patients. If they're not employees of the hospital, sometimes, "Do I really care if there's a high readmission rate?" They care about their patients. A patient's been in the hospital for five days. They don't want them bouncing right back. Part of our IDN strategy is really where the value proposition is strongest is an integrated delivery network where the physicians are either owned or aligned financially with the hospital. The hospital owns the pharmacy. The alignment there and the ability to impact those early discharges and those prevention, even at the emergency room. We're seeing some IDN hospitals. Patient shows up at the emergency room. They get a quick cardiac consult. They send them home on FUROSCIX. They get them stable and send them home. Really, our integrated delivery network strategy is all about that, is really capturing the value proposition of the product where the value can be saved by the IDN. That is really what we are focusing. Our IDN sales, we are up 12x from 2024 to 2023, a big gain last quarter, and we will have an even bigger gain this quarter. It is much easier for physicians to write. It is in their EMR. They can order it right there. It is easier for patients to get it. It is on campus. It is easier to prevent that admission at the hospital or to early discharge them. Obviously, you've been talking about IDNs. I'm just curious, sort of IDN is a catch-all phrase that's used. We have smaller IDNs, sort of local ones, although you also have sort of national IDNs or almost a national scale like a Kaiser. Do you see differences in how different IDNs operate, and are there best practices that you see, and how do you collect data, if you will, or access some of the data that some of those IDNs are generating, if they are generating it, to provide that teaching to other places? Yeah. So we've developed IDN protocols internally that we will, if an IDN asks us for, "Hey, what's best practice?" Cleveland Clinic just came on board. Two years knocking on that door till they finally came on board. They're going to be our biggest IDN outside of Kaiser. They've created their own protocol. Cleveland Clinic has a protocol that's blessed, and you can take that to some of the smaller IDNs. Each IDN, as you said, is different. You have the really large ones, the closed systems like Kaiser. The VA is the largest IDN in the country, but Kaiser is the second. Really different. They're very closed. They're actually using FUROSCIX in all of their home healthcare discharge, and they'll create data and write a paper on that to provide best practices. We're doing the same thing with Cleveland Clinic. They're using it a little differently. Northwell here, again, home healthcare here in Long Island. They're using it. So we have our own protocols. We'll work with the Cleveland Clinic to disseminate their protocol. Kaiser will actually produce papers and publish that. We'll create another, more data, more noise, and more protocols. The protocols are key, especially for the smaller IDNs that need them. You recently won approval for the chronic kidney indication. How does that sort of expand the opportunity? How do you anticipate sort of nephrologists using the product? Is it sort of in a similar manner, or is it different than the original sort of cardiologist target? Yeah. There's about 700,000 patients that have CKD without heart failure. If you look at a Venn diagram, you're going to have all of these heart failure patients. You have all of these CKD patients, and a lot of them have both. The kidney and the heart work really, really closely together. What we've noticed, we received approval for CKD back in March. This is CKD without heart failure and launched in April into nephrologists. Some of the things we're hearing is, "Where have you guys been? I manage all of the fluid from the cardiologist down the hall." We think the 700,000 patients, great, unique opportunity, adds to the TAM. The real opportunity is in those patients with what we call cardiorenal disease, where they have both heart failure and kidney, where we've been indicated in, but you're hesitant to go into nephrology without that kidney indication. So we're really seeing an uptick in heart failure treatment as well as kidney treatment and the cardiorenal treatment in nephrology. We think nephrology is going to be a big chunk of our business. We're looking at the early returns. It'll be a faster launch than cardiology. I can promise you that. When you say that, is that just given the fact that there is some familiarity with the product because you've been on the market for a while, or is it just that they are more receptive to the message that you're sending? Yeah. I think it's both, Doug. I mean, we did our ATU baseline in cardiology before we launched, and we did our baseline ATU awareness trial and usage in nephrology before we launched. It was about threefold higher in nephrology. They're more aggressive in treating. This is what they deal with, fluid all day. It's fluid. As I said, they, in some cases, are actually managing the heart failure of the cardiology patient. They use words like, "I'm going to get this patient totally dry." You don't really hear that kind of language from cardiologists. They're a little more conservative in how they use diuretics, not nephrologists. They're pretty aggressive. They're going to write probably bigger scripts. They've asked if they can use two devices at the same time or two in a day. They're very aggressive in getting the fluid off. I'm curious, from a reimbursement standpoint, when you say they're asking you to use two at a time, and I don't think you generally have quantity limits in terms of reimbursement. How are you thinking about that? Do you have to communicate with payers just to the extent that they start to see this increase in the quantity being prescribed for individual patients that they might start to think about imposing sort of quantity limits? Yeah. We'll see some quantity limits in state Medicaids, typically at four. The important thing on a quantity limit for us, they write for four, gets filled, the patient utilizes the four. The doc can write another script a day later. It is not an annual quantity limit. It is not a monthly quantity limit. It is a script quantity limit. We really have not seen that. We have agreements with the three big PBMs in Medicare to not institute quantity limits. We have not really seen it. Again, if the patient needs a drug, the doctor's going to write the drug. The plan, now that we know all of our patients have had to fail on oral diuretics, that is to the label. That is how they are managing it. We really have not seen restriction that way in quantity limits. Last year, we talked about adding nephrology. I think it's worth briefly touching on the fact that last year you added class IV heart failure patients. Obviously, you have a little more sort of experience with that or just that's been on the market a little longer with that indication. What are you seeing from that, and how did that sort of impact the opportunity for you? It really did two things for us. One, it opened some doors. Cleveland Clinic, a perfect example. You did not have class four heart failure. A lot of their patients are class four heart failure. Kind of come back to us when you have that. I mentioned Cleveland Clinic again. It is going to be a big driver this year for us. It opened doors in advanced heart failure clinics where they have a lot of class four patients. It also has impacted our script size. These patients, a lot of these patients, are on, I will call it maintenance diuretic therapy, where the doctor might write 12 and have them take this Monday, Wednesday, and Friday, put it on in the morning, call me if there is a problem, check in every Monday morning. You do not have to come back to the IV clinic anymore. You don't have to be hospitalized to get fluid off anymore. It has caused our script counts to go up a bit with the class IV patients. One thing that you talked about in the first quarter was the impact of the Medicare Part D redesign that went into effect in January. It sounded like it was a modest headwind in the first quarter, but you sort of think that it's going to ultimately be a significant tailwind for you. Maybe just walk through how you see this driving to your benefit over not just the course of 2025, but maybe over the long term, what this does for you in particular. Yeah. It's a little complicated, but something obviously, one drug on the market right now, it's a Medicare reimbursed drug, about 70%-75%. Like last year, our biggest headwind to net sales, to volume filled, were patients out of pockets in Medicare. We made a decision. We thought the value of the drug, we still believe the value of the drug, allows us not to give 50% rebates to the PBMs. We didn't. We did have some patients with high out-of-pockets. If a patient has a $2,000 out-of-pocket, there's a good chance they're not going to fill the drug. That was definitely a headwind last year. We saw last year with a cap. Now, they said there was a hard cap. It really wasn't. It was a soft cap at about $8,000. That when patients got through that cap in November, December, our fill rates went up. When our fill rates go up, when a doctor can write a drug and it gets filled, they will write more drug. This year, we had this full redesign of Medicare where patients' out-of-pocket cap, the maximum they can spend in a year, is $2,000. CMS also allowed them to smooth that, to actually spread that over 12 months. I think CMS was disappointed. We were at a conference two weeks ago where CMS said only 200,000 patients enrolled in smoothing. Those are probably patients, oncology patients, Parkinson's patients who know they're going to hit the cap. Our patients are heart failure patients. They have a lot of comorbid diseases with them. We were really pleased with how the redesign is going to help our patients. It is all about getting drugs to patients. Our patients have $2,000 caps on all their meds for the year. What we saw in January, patients had not hit their caps, did not smooth. We had that same headwind January and February. We saw in March, patients started hitting their caps or hitting a portion of their cap. Maybe they spent $1,000 already. Now, oh, it is only $1,000. I can smooth that over nine months. We have seen more and more patients in March, especially in April and May, that have hit their caps, that have $0 copays or low copays, and are filling drug. What that does, obviously, it helps our unit shipped, helps our net sales, but really drives demand. We are seeing a big influx of demand here, March, April, May. We think it really is a big tailwind to us. Plus, I also think we expanded our sales force in October. It takes a couple of quarters for them to have an impact. We're clearly seeing in April and May, March to a degree, the impact of that sales force expansion. You throw the kidney indication on top of that, which is just another accelerator. That is why we're so excited about what we've seen in the last two and a half months and what we really think we're going to see through the balance of the year and playing out next year. Next year, we'll have our auto-injector on the market, which we just think is going to be so much easier for doctors and patients. This is a five-hour wear. That's a five-second push and takes our cogs down 70%, but really is going to drive penetration with the auto-injector. I'm curious, in terms of the auto-injector, how does it fit into the strategy? I hear your point, and we've certainly heard it in other instances where patients like the simplicity of the infusers, you just sort of stick it on and forget about it. It is a little bit of a limiter in that over the time that you have to wear it, you can't shower, have to worry about it falling off. I'm just curious from your perspective how you see the eventual mix shaking out. Do you think most patients will ultimately gravitate to the auto-injector, or do you think the market will ultimately segment out? First off, the current product, FUROSCIX on-body infuser, the feedback from doctors, from patients, from nurses has been incredibly positive. This is the first thing that's kept them out of the hospital. It works in 30 minutes. It works every time. It's predictable. It's reliable. It's doing wonderful. To your point, I think there are a subset of patients that doctors say, "I'm not sure. They can't shower. Do they want to wear this around the house?" That auto-injector takes care of any of those limitations. What we look at is about a 90/10 split. We won't probably pull the on-body off the market for patients that have struggled with fluid overload, struggled with hospitalizations, struggled with 25 visits annually to an IV clinic, to have something that works, reliable, they trust, they have confidence in. We'll keep that on the market for those patients. We think eventually it'd be a 90/10 split, 90% auto-injector. Obviously, you think from a patient convenience standpoint, there are advantages. From a corporate level, what do you see as the big advantage of the auto-injector? Huge advantages. The big thing, obviously, is our COGS, which impacts our emergence. Our COGS go down about 75% with the auto-injector. Huge right to the bottom line. Again, we think it ramps up penetration. It extends our IP to 2040. In a more kind of technical term, it eliminates waste in our supply chain and really simplifies our supply chain as well. It is a lot better for the environment. Less plastics, no motor, no battery. It has just got advantages across the board. We are really excited. We will be filing the NDA next quarter, have it on the market next year. We see these growth accelerators really playing out through the balance of this year into next year, and then another accelerator with the auto-injector mid-next year. I guess just sort of in closing, what do you think are, because you've been coming out of the first quarter, you've been very sort of upbeat. What do you think are the three biggest drivers to drive sort of an inflection in sales through the rest of 2025? I think the Medicare redesign clearly for us is going to be one. When patients can fill their drug, again, it helps our net sales, helps our unit ship, but really it's kind of a halo impact and docs write more. The continued expansion of the sales force or the expansion of the sales force we did, seeing all of these reps now participating, it takes time to build this business. You just did not walk in and start shifting doctors from one oral drug to another oral drug. You created a market. These reps that have been out there a little while are really driving sales. The new reps are participating. Those two things, plus just the organic growth the product has when it gets on the market and does really well for patients and docs. You accelerate that with the kidney nephrologists. We really think those are the big drivers for this year, into next year, and beyond. Okay. I think we have to wrap there. Thank you very much and look forward to subsequent updates through the rest of the year. Great, Doug. Thank you very much.
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