Great. Welcome back, everyone, to another session here at Oppenheimer's 35th Annual Healthcare Conference. I'm Leland Gershell, one of the analysts on the biotech equity research team here at Oppenheimer, and really pleased to have with us as our next presenting company, scPharmaceuticals. The company is public, ticker is SCPH. On behalf of the company, we've got John Tucker, who's President and CEO. He'll be walking through a slide presentation on the story, and then we'll have some time at the end for some Q&A. With that, I'll hand the mic over to John. Leland, thank you very much, and thanks for giving us an opportunity to present. scPharmaceuticals, I think the name really says a lot. We use our expertise in technology to take drugs that are previously delivered in the highest cost setting, the hospital with the worst patient outcomes, and actually deliver that same efficacious, safe, and effective result, but delivered in the home environment where costs are less and care is better. Forward-looking statements. Again, commercial stage company. We're really focused in the cardiorenal space. We've got a fully commercial organization, regulatory development, so really focused in cardiorenal. Some investment highlights. We launched Furoscix. I'll walk you through Furoscix for congestive heart failure. We launched it mid-2022, did about $12.3 million last quarter, Q4, un audited, obviously gave us about $36.2 million or so in net revenue for full year 2024. Good financial position, have about $75.5 million at the end of the year. IP is strong. Our current product, the infusor, out to 2035. Our next product, our auto-injector, which we hope to file later this year, out to 2040. A lot of growth initiatives both for this year and beyond. We received our first expanded label in August for Class IV heart failure, August last year. This will be the first year we've had that. We have a PDUFA date coming up in less than a month for chronic kidney disease. This is edema caused by chronic kidney disease. This is going to add another 700,000 patients to the market. We think it's a huge value driver for us. Our auto-injector we'll submit later this year, which cuts our costs by about 75%, extends our IP, and really will be a growth driver on net revenues as well, as it's just much simpler for a patient to use. We are in heart failure right now. We're not, again, we'll have the indication for kidney hopefully in about a month. Heart failure alone is about a $9.5 billion opportunity, about almost 7 million patients in the adult, in 7 million adults in the U.S. that have heart failure. We don't focus so much on patients. We focus on how many times a patient will have a worsening heart failure event. That means about 4 million times a year. Not all patients. Some patients are on their oral Lasix, their oral diuretic, and they do fine. It's about a million to a million and a half of them that will run into problems with congestion. For some reason, the oral stops working. This is when patients start taking on fluid, they have gut edema. The bioavailability of the oral goes down to as low as 10%. The patient's getting in more and more trouble. The oral's working less and less effectively. What they need is 100% bioavailable furosemide. You can get that IV in the hospital or now you can get it at home with Furoscix. Worsening heart failure is the leading cause of hospitalizations in patients over the age of 65. That's why it's such a huge percentage of Medicare Part A and Part B spend, being almost 33% of it. Really, the value prop here is the potential for cost savings for payers, for hospitals, and a much better outcome for patients by reducing patient hospital admissions and readmissions. This is Furoscix. It's 80 milligrams of furosemide, Lasix, the brand name, delivered in an on-body patch pump. It's a picture over here. It's smaller than your iPhone. This patch pump with the 80 milligrams of furosemide really replaces a day in the hospital. It's fully disposable. You take it out of the box, you drop in the cartridge of drug, peel off the back, you put it on your stomach, you push the button, and you are not going to the hospital. It's going to work fast. Patients will have relief in about 30 minutes. We have a biphasic delivery. This is to optimize the PK, where we deliver 30 milligrams in the first hour and 12.5 milligrams each of the next four hours. We always talk, this is a bioavailability story. The oral is so variable and it can go down to as low as 10%. You're getting predictable 99.6% bioavailability and you're getting it quick. Patients are going to have relief soon. The diuresis, how much they're actually leaving the system, is the same as the IV. We've been able to match the PK and the diuresis of the IV. Here was our pivotal study where we compared ourselves to IV, where you can see that the total diuresis both at eight hours and at 24 hours is the same between IV, 100% bioavailable IV, and the subcutaneous Furoscix. This was our pivotal study, but it's also kind of a marketing study for us to show doctors, "Hey, you're going to get the same level of diuresis, but you're not going to have to send that patient to the hospital, to an IV clinic, wherever. You can get them relief immediately with Furoscix." That was our pivotal study. We've also done two other studies. Our FREEDOM study, which really was an HRU study, showed patients that presented to the hospital and were put on Furoscix and not admitted to the hospital versus a historical control of patients that were hospitalized. You look at the total cost to the system for these patients. The difference was $17,000 in heart failure-related events and almost $28,000 in overall healthcare costs reduced by using Furoscix instead of the historical standard of care. We followed that up with another study called AT HOME where we basically told physicians, "When a patient comes in with worsening heart failure, randomize them to either Furoscix or do everything else you can to keep them from being hospitalized. Double the orals, add another non-loop diuretic, give them an IV shot in the office, but just don't do everything else." It is Furoscix against kind of the kitchen sink. We saw a 37% relative risk reduction in hospitalizations, 4.5-pound greater weight loss at day three, improvement in five and seven-point dyspnea score is the thing that patients care most about, a huge increase in the Kansas City cardiac quality of life scale, and a giant improvement in a six-minute walk, 55.8-meter improvement in a six-minute walk at day 30. We have shown in our first study, we matched the PK of the IV. In our second study, that you can really reduce healthcare costs. In our third study, just in the real world, in the population, you can reduce patients' symptoms, you can keep them out of the hospital and make them feel better really quick. That is really the clinical story of Furoscix. We talked about the burden to Medicare. Heart failure patients represent about 11% of all Medicare patients have heart failure, but they are 41% of Medicare admissions. If you look at readmissions, which is being admitted in the hospital before 30 days of your discharge, 53% of Medicare readmissions are heart failure-related. This is why it drives the cost so much. In fact, CMS, because of these readmission rates, put a program, a Hospital Readmissions Reduction Program that highlighted heart failure. It actually penalizes hospitals now for excess readmission rates due to heart failure. This is the patient journey. You have a patient who's stable, who's treated with a loop diuretic, typically Lasix, furosemide. They start taking on fluid. This can be because of natural disease progression. It can be because they're non-compliant with their diet, whatever. They're starting to take on fluid. This decompensation really leads to reduced oral bioavailability. I said before about 10%. This patient now is taking on fluid. Their oral stops working. What does the doctor do? Before Furoscix, probably send them to the hospital. 60% of all these heart failure admissions can be avoided totally by using Furoscix because they're just related to fluid overload. Even when the patient's been in the hospital for four or five days, 50% of them are discharged and they're still wet. They still have residual congestion. Really, the opportunity is to intervene early in this cycle. Again, when we talk about the GI absorption, you talk about the diuretics, and then the bioavailability of oral furosemide goes down to as low as 10%, but it's incredibly variable patient to patient, even within that same patient. One day it might work. The next day it doesn't. That's the story of Furoscix. You know it's going to be 100% bioavailable. You know it's going to work on all the patients. And it's working out there. The feedback we're receiving from physicians and from patients is overwhelming on how fast and how well Furoscix works. I talked about the time to intervene. There's really kind of two big buckets we look at. First one, we call the hospital prevention period. These are the days or weeks when the patient starts getting worse. This doesn't just happen overnight. They start putting on fluid. They're still taking their oral. The oral's becoming less and less bioavailable. They're continuing to put on fluid. That could go on for a couple of weeks. Right there, as soon as that patient starts taking on fluid, the patient knows their dry weight. The doctor knows the dry weight. Right there, intervene with Furoscix. Get that fluid off. Get them back on their oral meds. We're not a chronic med. I always say this is an acute intervention into a chronic problem. They'll take on all this fluid. They'll go on Furoscix for four or five days. They'll get back to their dry weight, and their orals will start working again. That's the first intervention window. It's really this prevention period before they get so bad they have to be hospitalized. Even after they're hospitalized, really at discharge, we know that almost 50% of these patients are discharged with residual congestion. We have a lot of IDNs in hospitals now. They're "finishing the job." They're discharging. Maybe they discharge them a day or two early, or they're just discharging them on a regular schedule and giving them Furoscix to make sure they're congested and they finish the job. The other point post-discharge is day three, day five. They come back for their post-discharge visit. They're still residually congested. The doctor's worried that patient's going to bounce back in the hospital. The hospital's going to get penalized. The doctor's going to get penalized. Right there, what do they do before Furoscix? They'd send them to IV clinics four or five days in a row. Don't do that. Just put them on Furoscix and keep them from bouncing back into the hospital. Talk about the commercial opportunity. Excuse me, for one second. There are about 6.7 million patients. I talked about the 4 million addressable events on an annual basis. Half of them will resolve by doubling the oral. We really look at about 2 million as the opportunity for Furoscix. At cost of intervention with Furoscix, Furoscix is $4,700 compared again to a $15,000 hospitalization. It gets you to about a $10 billion addressable market opportunity. We have all the stakeholders aligned here, and that's not usual in a pharma story. For the payers, the average cost just on the DRG is $11,840. If you look at the other costs, the hospitalization, I mean, the emergency room use, the admission, and then the DRG, these hospitals are underwater already. The real problem for them is when this patient is readmitted. As I said, heart failure is the top condition targeted by the Hospital Readmissions Reduction Program. Again, the payers are aligned. The hospitals, hospitals love full beds. They just do not like full beds of heart failure patients. They overstay the DRG. The DRG is calculated at 3.9 days. The average length of stay of a heart failure patient is 5.24 days. They are underwater, and they are at risk of that readmission and that penalty. When you talk about physicians, these patients are tough patients for them. They are suffering a lot. They are putting on weight. They are constantly straining their heart. These docs want to get these patients, get that fluid off to prevent further damage to the heart as soon as possible. They do not want to admit these patients to the hospital. These patients are sick. They're the ones that are most likely to have a poor outcome, catching a nosocomial infection in the hospital, COVID, whatever. It is in the physician's best interest to try to treat them before they get this sick. For patients, these patients aren't running marathons, but they want to do what they do. They want to be home. They want to be with their spouse, their kids, their neighbors. They want to walk the dog. They can do all of that wearing Furoscix. It doesn't interfere with any of their activities of daily living. They don't have to be hospitalized for four or five days just to get fluid off when you can now do it AT HOME. Talk about some of our performance. You can see the growth quarter over quarter. We did do a small targeted launch. We only had 40 reps out there. We expanded our sales force in late October of last year. This will be the first quarter we've had the 40% increase in the sales force size. You can see we're continuing to grow revenue 20-25% a quarter. We looked at doses filled, and you can see nice growth here, especially from Q3 to Q4. We anticipate to continue to see the growth in doses filled with the expansion of the sales force. We have the chronic kidney indication coming. We have the Medicare redesign where patients out- of- pockets are now reduced by about 40%, and they have the ability to smooth these out- of- pockets. We do have some patients that have high copays. In 2025, those copays are going to go down. We anticipate continued growth. We took long-term growth initiatives. I talked about the Class IV heart failure. We had that approved in August. They're about 10% of all patients, but they're the highest utilization patients. So our script size is typically six. In Class IV, it's eight. These patients are the sickest of the sick and actually need more care. We talked about CKD. We submitted that back in July. Our PDUFA date is next month, and we're very confident we're going to receive that approval, launching kidney in April in the nephrology offices. Again, we think at the end of the day, the kidney, the nephrologist will be about 40% of the total of the product. A real big growth driver coming up in a month or so. Talked about the sales force expansion, which happened in Q4. This is allowing us the first full quarter with the extended commercial presence. Our auto-injector, we've already got the PK data, which is our pivotal trial. We're planning to get this submission in mid this year. It's a game changer on the cause, again, reducing them 70-75%, but also giving another option to physicians. The feedback from the physicians we've talked about has been overwhelmingly positive. Talk a little bit about Class IV quickly. Again, we received approval in August. These are the most symptomatic patients. A lot of them are palliative care, and right now they're being taken from the home to an IV clinic three times a week back home. They sit at the IV clinic for four and a half hours to get diuresed to this AT HOME. We're seeing doctors write scripts now as big as 12. They're basically treating these patients, telling them, "Take this Monday, Wednesday, and Friday. Take it," and then they give them a month's worth of treatment. Again, it's about 10% of all the heart failure patients, but it probably represents about 50% of the cost of the hospitalizations. Chronic kidney disease. Fluid overload is really a huge effect and cause of kidney disease. You talk about mortality. You talk about delaying dialysis. You can do all this by keeping that fluid off. If you talk about what untreated fluid does to CKD patients, reduced quality of life, higher healthcare costs, again, a strain on the heart. Currently, oral diuretics are the cornerstone of treatment. They use the orals. They'll double the orals. They have the same issues when a patient starts having gut edema. It's the same problem. The bioavailability of the oral goes down. That patient now needs IV. Untreated fluid overload in CKD patients. Again, there's a number of clinical complications from reduced quality of life, higher cost, all the issues cardiovascularly, and obviously renal complications. You really untreated fluid overload can really cause worsening in renal function, potentially leading to a kidney replacement, dialysis, or mortality. The size of the market, again, there's about 6.5 million patients with CKD that are treated. Some of them are doing fine. It's about 700,000, as I mentioned, that need Furoscix. At an average cost of $4,700, again, it's about a $3 billion additional addressable market. It's much more concentrated in nephrology. There's about a third, a third of the cardiovascular of cardiology that are nephrology. It's a much easier market to address and impact. What are we doing to get ready? Obviously, KOL identification, outreach, support on the KOLs. We've done a ton of market research. We're almost finished developing all of our marketing materials. We've actually started calling on CKD already with our sales force. We're already indicated for heart failure. Some of these patients have both CKD and heart failure. We can call on nephrologists now. We've started doing that, not at a high level yet, but just the biggest offices to get ready for the launch. Obviously the sales force expansion. We'll continue to call on the cardiologist as well. The auto-injector, here's a picture of it. We had PK data we announced in August. That's our pivotal data. We're targeting the submission mid-year this year. The patent goes out to 2040. Again, it's another option for providers and patients. The feedback by the doctors has been amazing on the auto-injector. For us, our costs went down dramatically by 70-75%. Here is our PK study, our pivotal study. Again, this is against the IV. We are showing similar bioavailability. It is actually a little bit better than the IV at 107%, but within the 90% confidence interval of 103-110. This is our key clinical study. We will be able to file the auto-injector later this year. If you look at all of our secondary, and this is how you really get approval. You show the PK, and then you show what the PD endpoints look like. You can see urine output is the same between IV and the auto-injector, as is sodium, and potassium was the same as well. We achieved the primary endpoint between 80-125%. We achieved all the secondary endpoints, and it was really well tolerated. There wasn't pain from the injection or pain from the drug. We're really excited. We can't wait to get this filed into the FDA and get the product on the market. Summary again, a good launch, a good year last year, $36 million, strong financial position, about $76 million, really strong IP out to 2040, and both short and long-term growth initiatives for this year. Obviously, it's a sales force expansion for the first time. It's Class IV for the whole year. It's kidney in April when we launch it. It's the Medicare redesign that has lowered patients' out-of-pockets. We think we're in a really, really good position. I just want to thank you very much for attending, and thank you, Leland. Absolutely. That was great, John. Thank you for that overview and update. Just to, you know, it's time for a few questions here. I think, so first, as you approach the upcoming regulatory decision, obviously, I think you said it's about a month away. Any concerns there? Anything to comment on back and forth? Yeah, dialogue, I'll be honest, dialogue with the FDA has been pretty, it hasn't been a lot of it, which sometimes is good, sometimes is bad. They had questions very early on, two questions. Those are the only questions we received. So we feel really confident. It matches the IV label. The dialogue has been great, the feedback from them, their responsiveness. March 6th, we're fully anticipating approval on March 6th. Right, that's terrific. You touched on the Class IV. I know that's kind of sort of a recent segment that you've launched into towards the end of last year, but just wondering kind of what you're seeing there in terms of the percent of that in terms of your sales, and the script size may have changed a bit with that. Just wanted to get some more metrics, maybe if you could share those. Yeah, if we looked at December, in December alone, it was about 12% of all of our scripts were coming from Class IV patients. Our start form allows the doctors to check off what class they are. The script size, again, typically averages six. In Class IV, it's eight. It averages eight units. We're seeing uptick there, both in scripts, but also in the size of scripts. Got it. Okay, that's really helpful. I guess just, you know, I don't know, I guess we're obviously coming to our Q4 report, which should be coming soon. Anything about seasonality for Q that we should be concerned about? You know, not really Q4. You know, maybe there's a little because of holiday heart patients not being diligent around their diet. So some docs did write some scripts in anticipation of those patients. Q1 is always a little bit more challenging just because deductibles reset, but not really anything seasonal in it. All right, good. Good. You know, copays, as I've been pretty, yeah. I mean, if there was a headwind last year, it was patient out- of- pockets in Medicare Part D plans, not the Advantage plans, the PDP plans. Patients out- of- pockets last year, you know, for a patient to get to catastrophic, you know, was probably, they said it was $3,250. It was really more like $4,000. They've taken that down. Medicare, the redesign has taken that down to $2,000. So a patient in PDP or in Advantage, Advantage isn't the issue really, it's PDP. Copay has been all the way down to $2,000. CMS has also allowed them to smooth the payment so they can pay $166 a month and have no copays for any of their medications. Being heart failure patients, they tend to be on a number of medications. We really think that with the redesign, more patients will have eligibility. You know, it hurts you two ways when a patient has a high copay. Maybe the patient doesn't fill it because the high pay is too high. The doctor might hesitate to write it if he thinks for most of his patients the copays are going to be too high. We are really, you know, especially as we, you know, I think for patients, it's been a little confusing, the rollout of the new Medicare redesign and how they sign up and all that, but that's all kind of working out. We really think that it's going to be advantageous to us. All right, good. You are seeing the benefits. I think you had sort of streamlined the hub. That's a thing out. Yeah, we've done a lot of work on the hub to make it just as easy for physicians to write. We are doing a lot of work with IDNs now, and they have their own EMR electronic. The doctor can now enter it in an IDN right in their EMR, and it goes right to the IDN pharmacy. We doubled our IDN sales from Q3 to Q4. I anticipate us doubling it again in Q1. We have really focused on these IDNs. I know we all think of Kaiser, but there are, you know, hundreds of them in the U.S., big ones and some smaller ones, but we have really focused. The value prop is the cleaner there, the cleanest there, Leland, where the IDN has the cost of the hospitalization, the cost of the drug, the cost of the physician visit. We are really seeing a nice uptick in the IDNs. Excellent. Good stuff. I think we covered pretty much all the bases here. Again, looking forward to upcoming progress on the FDA side, and then also, you know, later in the year as well, as you look to further expand. Thank you very much, John. This has been terrific. Thank you. It's great seeing you again. Thank you. Yeah, and thanks everyone for tuning into our session here with scPharmaceuticals. All right, have a great day, everyone.