Everybody, thank you for joining us at the Citizens Life Science Conference. I'm Jason Butler. I'm one of the BioPharma analysts here at Citizens. Excited to kick off this conference this week, specifically excited to be joined by our first company, scPharmaceuticals. scPharmaceuticals is a company focused on the cardiorenal space, is launching a product called FUROSCIX, had an exciting announcement just a few weeks ago with a label expansion to patients with Chronic Kidney Disease. Excited to be joined here by John Tucker, President and CEO. John, thank you for being here. Thank you. Great. Jason, thank you very much. Thanks, JMP and Citizens for allowing us to present the story. As Jason mentioned, really patient-centric, just focused on cardiorenal. Commercial stage company, which I know nowadays is pretty important. Commercial launch of FUROSCIX, we did $12.2 million in Q4. We haven't done Q1 yet. We'll be doing it next week. $36 million for the full year in 2024, our first full year. Analysts have us at about $73 million for this year. We feel good about that. Strong financial position, $76 million, almost $76 million at the end of 2024. Patent protection on our current product, which is our on-body five-hour infuser, to 2035. We're really excited about our auto injector program. The IP goes out to 2040. It changes the delivery from a five-hour on-body wear to a two-and-a-half-second push, lowers our COGS by about 70%-75%, which really flows to the bottom line. Long-term growth initiatives. We got an expansion in the second half of last year in class four heart failure, which are the sickest patients in heart failure. New York Heart Association Class Four. We were originally approved for two and three. As Jason mentioned, we announced we've received approval and expansion in Chronic Kidney Disease. We received that in March. We actually launched that last Monday, already seeing scripts for kidney from nephrologists. Our auto injector submission in 2025. One external growth factor, which we think will be the most impactful for us this year, is the Medicare redesign. I know for some companies, it's not a great thing. For us, it's a great thing. Lowering patients' out-of-pockets to $2,000 cap this year, allowing them to smooth that $2,000 over 12 months. We've already seen the positive impact on this. Now, you get a little GTN hit in the first quarter, but we're seeing in March, April, and May a big increase in our fill rates, increase in scripts written, and that all means an increase in unit shipped and then revenue. We think for 2025 and 2026, that redesign is a real tailwind at our back. Talk, oop, let's see if I can get this moving. Heart failure, about a $10 billion market opportunity in the U.S., about 6,500,000 million patients annually. We don't look at really count patients, we count events. How many times these patients have a worsening heart failure event? And it's about 4,000,000 million times. It's about a million, a million and a quarter patients that cause these 4,000,000 million events. Congestion's the hallmark. Fluid overload. That's why they're getting hospitalized. In patients 65 years of age and older, it's the number one reason for admission and readmission into the hospital, which causes it to be incredibly expensive for CMS, for Medicare. About a third of all Medicare Part A and Part B spending is on heart failure patients. Really, from an HEOR standpoint, the real benefit for the system is treating these patients outside of the home, avoiding the admission and the costly readmission. This just kind of puts it in a graph. Patients with heart failure are about 11% of the total Medicare population. So 11% of the population is driving 41% of the admissions and 53% of the readmissions. This is what's really driving the cost. These are why these patients are so expensive. What's our solution? What these patients, this is really a bioavailability game. These patients are on oral Lasix, oral furosemide, maintenance dose. Almost all six and a half million patients are. It's when they have a worsening event of heart failure. Again, the hallmark of that is fluid, that the bioavailability of the oral goes down to 10%. The patient's getting worse, and the medicine that's supposed to help them get better is actually working less. They need 100% bioavailable furosemide. That's what they need, 100% bioavailable Lasix. Before FUROSCIX, the only place you could get that is in the hospital, or for some patients, they'd go to IV clinics four or 5 times a week, having to go there and sit in bed for five hours. We've developed a pH-neutral formulation of furosemide. The IV has a pH of 9.5. You could never give it subcutaneously. It would be like putting detergent under the skin. It's indicated to treat congestion due to fluid overload in patients with chronic heart failure and now with Chronic Kidney Disease. It's an on-body infuser. It's smaller than an iPhone, that the patient just simply opens it up, drops the cartridge of drug in, peels off the 3M tape on the back, puts it on their stomach, presses the button. That device, that drug device combo, it's regulated, it's a drug, replaces a day in the hospital. It's as simple as that. These patients aren't running marathons, they're heart failure patients, but they want to be home. They want to be with their friends, their wife, their husband, their children, their neighbors, their dogs. They don't want to be in the hospital. We keep them out of the hospital. For those patients who first start having signs of congestion, I mean, they can't get out of bed. They can't walk up the stairs. They can't go get the mail. Treat early with FUROSCIX. It's a bio, how we deliver the drug is a biphasic delivery. We give them a bolus dose of 30 milligrams in the first hour. That gets them diuresing, getting the weight off. Then it's a smooth delivery of 12.5 milligrams each of the next hours for four hours. This will get the fluid out. The bioavailability, 99.6%, and equivalent diuresis, equivalent amount of fluid overload as that day in that hospital, that IV. You're going to be feeling better in 30 to 60 minutes. You're not going to be going to the hospital. You're not going to be admitted through the hospital. You're not going to go to an IV clinic five days a week to get fluid off. You're going to do it at home. Here's our pivotal study. Also, our marketing study really shows PK equivalent to the IV. That's all we wanted to do. Say you were getting equivalent PK and PD, which is the diuresis, the amount of urine you're getting out. And it's the same with our drug as it is with the IV, which is exactly what we wanted to show. This was the basis of approval. That was our Phase 3 pivotal study. We've also done post-marketing studies, Freedom HF study, which really what we did is patients showed up at the hospital, fluid overload, randomize them to treatment as usual, go to the hospital, or FUROSCIX. We saw a difference, and the primary endpoint here is heart failure-related costs. Saw a difference in $17,000 in how you treat these patients. You hospitalize them, you're driving up the cost to healthcare. You give them FUROSCIX and send them home. 96% of the patients in our study never went to the hospital in that 30-day period. 100% of the patients in the comparative group did, and 30% of those were readmitted to the hospital. We did an at-home study. This is a study saying if you're in an acute situation, you can take FUROSCIX and avoid being hospitalized. In our at-home study, we went a step further. We said, "Okay, patient shows up at the doc's office. They're not ready to be hospitalized. They're having signs and symptoms of congestion. Randomize them to FUROSCIX or throw the kitchen sink at them. Double their oral, triple their oral, add a non-loop diuretic, send them for an IV. We saw statistical significant difference across the board in weight loss, in dyspnea score, which is the biggest symptom, the shortness of breath, in hospitalizations, in quality of life. Every metric we measured showed a difference between throw the kitchen sink at them or just give them FUROSCIX. What is this patient? Again, our patients are stable. I like to say this is an acute intervention in a chronic disease. These are heart failure patients. There is, again, about a million, 1.2 million of them. They are on their orals. They are doing fine. All of a sudden, dietary non-compliance, exercise non-compliance, just progression of disease. They start taking on fluid. The fluid retention, again, is the hallmark of heart failure. What this decompensation, what this fluid overload does is it causes the bioavailability of the orals to decrease dramatically and variably down to 10%. What do doctors do? They double the oral, they triple the, they do everything to keep that patient from being so sick they have to go to the hospital. We know, and the doctors know, when a patient gets that sick and they have that much fluid, we're talking 30-40 pounds of fluid, they're structurally damaging their heart, and you're going to see the next admission and the next admission getting closer and closer together. What we're doing is intervening right there, right when they start that fluid retention to keep them from going in the hospital. This is the story. I've talked about it enough. It's the highly variable bioavailability of oral furosemide. 10% one day, 20% the next day. You don't know. The doc doesn't know. The patient doesn't know. FUROSCIX, 99.6%, predictable, works every time. When we talk to doctors, and especially the patient testimonials we hear about, "Oh, I've been in the hospital five times in the last year for fluid overload. I have your product. I don't go to the hospital anymore." It is really doing what it's supposed to do out there. The testimonials from physicians and patients have been amazing. Here is our opportunity for intervention. There is what we call the prevention period where that patient first starts having signs. Again, they're a heart failure patient. This isn't a primary care drug. Our call audience is cardiology. They're at the cardiologist because they have heart failure. They start to have worsening signs. "Hey, doc, my slippers aren't fitting because of all this swelling in our extremities. My fingers, I can't get my wedding ring off. I walked to get the mail and I was really short of breath. Intervene there, right there. That's FUROSCIX, right there. Don't let that patient get worse. Treat that patient. Yeah, maybe you can double the orals and wait 10 days and hope and pray that you got enough on. Don't do that. Use FUROSCIX. We're not going to get 100% market share. These patients, some of them will end up at the hospital. 50% of patients that get discharged from the hospital after a worsening heart failure event have residual congestion. They're discharged wet. They are at risk of bouncing back into the hospital. What CMS did because of this problem is they actually introduced a hospital readmission reduction penalty for these hospitals that have excess readmissions. Think of it from CMS standpoint. They just paid $12,000 to the hospital for this patient, to care for this patient. The patient goes out, they're back in the hospital in two weeks, another $11,000, $12,000. CMS said, "Enough with it. We're going to penalize you, your Medicare. They're going to withhold Medicare dollars from hospitals for excess readmission." If a patient is discharged wet, and sometimes they don't know, but what we're seeing, especially in our integrated delivery networks, they're discharging a day two. They would never do it before FUROSCIX because they worry about bounce back. Finish the job at home. Get them stabilized, give them two days of IVs, send them home with FUROSCIX, finish the job, don't worry about readmissions. The patient's discharged, they come back post-discharge visit, day three, day five, they're still residually congested. You're really worried as a cardiologist. That patient is bouncing back. Give them FUROSCIX. Give them three days of FUROSCIX right there. Talk about the commercial opportunity. I mentioned the six and a half million patients. There's about four million events that these patients contribute to. We think about half of them are addressable with FUROSCIX. Some of them will resolve. Some of them will double in, the oral will work. Excuse me. There's about 2.1 million times where we can intervene at our average cost of therapy. This is a fully disposable. They use it once, they throw it away, they put another one on the next day. This is our average cost per episode of about $4,700. It gives us about a $10 billion market opportunity. This is a really interesting opportunity where your stakeholders are aligned. I've done this a long time, and you have stakeholders that have different incentives. Here with the payers, why are the payers incentivized for FUROSCIX? They want to avoid Medicare. They want to avoid that $12,000-$20,000 admission, right? They don't want to pay that. FUROSCIX gives them the opportunity to not pay it. That's where the payers are aligned. Hospitals, everyone's like, "Oh, hospitals love full beds." They do. Hospitals love full beds. They don't like full beds of heart failure patients. Two reasons. One, they overstay the DRG, diagnosis-related grouping payment, which pays 3.9 days. They stay 5.2 days. They overstay the DRG, and then they bounce back, and the hospital gets penalized. Now what the plans are doing, CMS penalizes the hospitals with the Medicare withholding. The plans are now cutting the reimbursement 50% on any patient readmitted within 30 days of initial discharge. Hospitals are acutely aware. What do hospitals do when they're worried about readmissions? Like they do in Germany. Germany's readmission rates are half of ours. They stay in the hospital 12 days. For simple congestion, you could do diuretic management at home. That is what hospitals do. The hospital administrator comes to the doc and says, "We got to cut down our length of stay." FUROSCIX allows them to do both. Cut down your length of stay and reduce readmissions. Doctors, it is a failure of diuretic management if a patient gets so sick that they have to be hospitalized. These are heart failure patients. They are the most vulnerable to bad outcomes in a hospital, not just the cost. Nosocomial infections, COVID, heart failure patients. They are the sickest of the sick. Doctors do not want them in the hospitals. They also know if they have an event where they have 30 pounds of fluid on, that they've structurally damaged their heart and that next hospitalization, that next worsening heart failure event is closer and closer. These patients, these are our moms and dads, our aunts and uncles. They don't want to be tethered in a hospital bed for five days. Again, they're not going to run marathons, but they want to do what they want to do. They want to be home. They want to be with their neighbors. They want to walk their dog. We have a situation where all of our stakeholders are aligned. Excellent here. Here's our net revenue by quarter. Again, growing nicely, $12.2 million in Q4 2024. Doses filled by quarter. This is really the leading metrics to net revenue. We saw 13,300. Q1, we have not announced it, but I have said it publicly. We will ship more units to patients in Q1 than we did in Q4. We do have a little GTN headway in Q1. Q1 is tough for Medicare drug. All the out-of-pockets reset. It is tough for every commercial drug. What we are seeing, again, as I spoke earlier, is this Medicare redesign. We can get into why it is bad for some companies. If you have been paying 60% rebates to be on preferred formula, if you have done that as a company, you will get no more access from the Medicare redesign. All you are going to get is an additional mandatory rebate of 10-20%. Last year, we had no contracts, no contracts in Medicare. So yeah, we had high copays in about 30-35% of our patients. High copays. If a patient has coinsurance and they have a $4,000 bill, we're going to lose that patient. They're going to probably end up in the hospital or they're going to have to struggle through doubling and tripling the orals. This year, with the redesign, that cap is $2,000. Our biggest headwind has been removed. What we're seeing was tough in January and February. No patients had gotten through their cap. It changed in March. We're seeing patients enroll in smoothing where they can take that $2,000 and spread it over the whole year. These are heart failure patients. They have a number of comorbidities. They've hit their cap. In March, we saw our unit ship go up. In April, our fill rate went up dramatically. Our fill rate went up. Our unit shipped went up. When that happens, the doctors write more because they know patients can get it. All of those dynamics we've seen, now it's early in Q2, but we really feel like this is going to be a big driver for us this year and that we're going to see our fill rates continue to go up. We've said publicly be to 60% in Q4. More scripts as docs can write more. We're going to be more excited about what we've seen March, April, and the beginning of May. Some of our long-term growth initiatives, I mentioned these. Class 4 heart failure, the sickest of the sick patients. Their doses per script for a normal patient, it's 5 or 6. These patients are being used kind of preventatively where the doc knows this patient needs enhanced diuretic response every week. They're writing 12 FUROSCIX. They get three a week. Put this on Monday, Wednesday, and Friday, and you do not come see me anymore. Call me on Friday. Call my nurse. Let me know how you are doing. Higher script value for Class 4. CKD. Nephrologists deal with fluid all the time. In fact, what we are seeing is a lot of heart failure with co-concurrent CKD is actually treated by the nephrologist. I think our heart failure use will go up now that we are calling on nephrologists. They deal with fluid every day. It is what nephrologists do. We are really excited about what we have heard initially. We have already seen scripts coming in, and we launched last Monday. The 80-milligram auto injector, as I mentioned, we will be filing for that later this year. Game changer in a lot of ways. I mean, it's the same patient, but there are patients that might not love wearing a five-hour infuser. This is 2.5 seconds. It's the same auto injector they use for Wegovy. Patient will put it, well, they'll just take the cap off, put it to their side. They'll get a day of therapy. Lowers our cost by 70%. It gives us just so much flexibility if we did want to go discount, which we haven't done, and I don't want to do. If Medicare plays out the way we think, we're not going to have to. This is going to flow to our bottom line. The extended commercial reach, we expanded the sales force in Q4. We're starting to see the benefits. It takes two quarters to really see the benefits of an expanded sales force. It's expanded our reach, but maybe more importantly, really given us that frequency and those high-volume accounts we need to be in every week. We're really thinking this is going to, is one of the reasons we're seeing the inflection of growth in late Q1 and Q2. To talk about CKD, it's an unmet need in fluid overload. These patients are on diuretics. They're failing on diuretics. We consider this pre-dialysis. The patient's pre-dialysis, what we've heard from nephrologists, they're going to use it during dialysis. We're not contraindicated there. We're not indicated there. They can use it there. Some doctors have said, "Boy, I'm going to use this in advance. Maybe I can delay dialysis by doing that." Again, it can lead to multiple clinical complications. Because the kidney and the heart work so close together, you have fluid overload due to CKD, you are going to cause problems cardiovascularly down the line. Again, untreated fluid overload leads to additional renal complications, quality of life. It's the same kind of value prop. The DRG is pretty close to the same. These patients are going to be hospitalized unless you can get that fluid off. Opportunity, it's about 700,000 patients in CKD that don't have heart failure. Again, we're looking, and we say cardiorenal. What's cardiorenal mean? It means patients with heart failure and Chronic Kidney Disease. We really have three indications: heart failure, Chronic Kidney Disease, and cardiorenal where the patient has both. If we exclude all of the patients that have heart failure, it's about 700,000 patients with a $4,700 cost of therapy is about a $3.3 billion market opportunity. Pre-launch readiness, we did all the things you do. KOL outreach, identification, a ton of market research, marketing materials based on the market research, the positioning, the messaging. We started calling on them in late Q4, the big ones, because we're indicated for heart failure. We're in nephrology talking about the patients with heart failure. We're getting a bit of a running start. Our ATU, which is an awareness trial and usage before launch in kidney, was 3 times what it was before we launched in cardiovascular. We think we're going to have a much quicker uptake in nephrology. Talk a bit about the auto injector. There's a picture of it. We did our pivotal study back in August of 2024. We'll be able to submit the NDA this year. Again, the patent of 2040, it'll aid our penetration. We love our product. It's doing amazing, the on-body infuser, patient-physician response. This will open up some new patients to the opportunity. The COGS benefit is huge. Here's our PK study. The goal was to have bioavailable equal to the IV. We showed that. We had to do pharmacodynamic endpoints because the PK isn't the same. It can't be the same. You got an IV peak. What we were able to do is show similar PK and similar PD, diuresis, natriuresis. Met the primary endpoint, achieved all of the secondary endpoints, and it was safe and well tolerated. In summary, the commercial launch accelerating now due to the expanded sales force, due to the redesign, due to the kidney. We haven't seen the impact of the kidney yet. We're seeing the inflection point we've been waiting for. We're seeing right now, or we saw last month and in March, great patent protection, and there are growth initiatives coming into this year. That's the story. Thank you, John. I'll just start off with a couple of quick questions. Can you just give us the initial experience in kidney? What are the types of patients that docs are trying the drug on? Yeah. Again, if you're a dialysis patient, it's not going to be part of the bundle. It's not at the dialysis center. It's not there. What we've heard and where they're trying it is our patients that are dialyzed and they still have excess fluid and they can use this in between dialysis. That's not really where we're positioning it. Nephrologists are way more aggressive in treating fluid. They use words like, "I got to get this patient totally dry." You'd never hear a cardiologist say that. They are way more aggressive. In fact, with our auto injector, we'll be able to have a second dose at 40 mg. The doctor, especially the nephrologist, can go to 120 milligrams. They are really looking at stage two, stage three patients as kind of the sweet spot. They identify stage one, they'd use it there too, but it's really two and three. They are really aggressive. Again, some of them are thinking, "Boy, this is going to delay dialysis." Now, we're not indicated. We can't promote there. That's just the market research. It should be two and three patients early. They write lots of doses. Again, it's just when you do the market research and you look at the things that they react to versus what a cardiologist, cardiology are much more conservative in managing fluid than a nephrologist. I'm just looking out longer term. How do you see the auto injector and the on-body coexisting? Where will the on-body still have value in these? Yeah. For patients, and again, the experience we've received hearing from these patients, the patient's been in the hospital 10 times in the last two years with fluid overload. You know how a product that keeps them out of the hospital, but keeps them home. I mean, that story about that gentleman with his dog and how he'd have to try to find someone to take care of his dog every time he was hospitalized. I think they're probably going to have some reluctance to move off something that's dramatically changed their life to something new. There are some doctors who like more of an infusion than a bolus. Our plan is to keep both products on the market. We will aggressively move the market to the auto injector. I've said this publicly. We think it ends up 90-10, 90% auto injector and 10% on-body. All right. Thank you very much, John. Thank you. Okay.