Great. Welcome back everyone to the next session, apologies we had a couple of technical issues, but we are back. I'm Roanna Ruiz, senior biotech analyst here at SVB Securities, it's my pleasure to introduce the management team of scPharmaceuticals. We have John Tucker, CEO, we also have John Mohr, SVP of Clinical Development. Welcome both of you, I will pass it to John for a presentation of the company. Great, Roanna. Thank you so much, and welcome everyone. Typical forward-looking statements. Today I'll be quick. A quick overview on the company and then a disease overview, and talk about FUROSCIX where, you know, we're on the verge of launching and incredibly excited, and then spend a little bit of time on the commercial opportunity. The company highlights. scPharmaceuticals, the name really says what we do. We take drugs that are already in the hospital being delivered IV, and create new formulations, new delivery systems to drive the care from the hospital, the highest cost setting of care, to the home where it's lower cost setting of care and you typically see better patients' outcomes. Our lead product, FUROSCIX, received FDA approval for the treatment of congestion due to fluid. We received this approval in October. We have announced that we are launching next week and incredibly excited to be able to make this really important product available to patients, nurses, and physicians. You'll see a real clear value proposition, established reimbursement model for FUROSCIX. We've got great IP out on the drug product to 2034. On the infuser, we partnered with West to 2035. Strong cash position. We haven't announced Q4 yet, but we ended Q3 with $45 million, which doesn't include a $50 million follow on we did in November and a $50 million debt deal we did with Oaktree right at approval. Strong cash position into 2025. A little bit about the board. Bill Abraham, probably the top heart failure specialist in the country is on our board. Jack Khattar is our chairman. I put Len Schaeffer, who heads up the Schaeffer Institute, founded WellPoint, and was past head of CMS. He sits on one for-profit board, and that's our board, mainly because he really believes in the value proposition, and believes that, you know, we need to improve care and lower the cost of care. Our top investors are OrbiMed, 5AM, RA Capital. Talk about heart failure, big market. About 6.7 million adults in the U.S., about 16 million adults in the G7. We really focus on how many times a year that they have a worsening event where they actually need enhanced diuretic response. That happens about 4 million times a year, where the oral generic loop diuretic they're on just isn't enough. That's about 4 million times a year that FUROSCIX has an opportunity to help these patients. That equates to about a $7 billion market opportunity in the U.S. Congestion due to worsening heart failure, one of the most common causes of hospital admissions in patients over the age of 65. In fact, it's a big market, but it's also a big problem. Heart failure patients represent about 1/3 of all Part A and Part B spending, a whole third of all that spending, that's driven by the cost of the hospital admissions and readmissions. If you look at it this way, so Medicare, only about 11% of Medicare patients have heart failure. They represent about 41% of all of the admissions for Medicare and about 53% of all the readmissions. Big market, big problem, and what's driving this cost and this burden really is the hospitalization. Again, they're about 1/3 of the total Part A and Part B spending, heart failure patients. The cost of the DRG of the hospitalization is $11,840. We know it costs more like $15,000 to hospitalize these patients. When you look at the total cost of care for heart failure patients, 80% of it is due to the cost of the hospitalization. Here's a little bit of the patient journey. You have a stable patient. In fact, with 6.5 million patients, most of them stay stable all year. They're on their oral diuretic, their oral Lasix. They're doing fine. All of a sudden, something happens. It could be dietary issues, could be just a natural progression of the disease, but they start taking on fluid. They start getting congestion. This is really the hallmark of heart failure. This congestion really leads to reduced bioavailability, the orals. They're taking 6, 80 mg, 60, 80 mg of oral Lasix, but the bioavailability went down all the way to 10% of that. They're actually only accessing 8 mg. They're trying to catch themselves. The first thing the doctor will say is, "Double your oral. Let's see if we can get more Lasix on board." Typically, it doesn't work, and these patients continue to get worse, continue to take on fluid. The doctors have no choice now. They have to get the fluid off. The way to do that is with an IV diuretic, IV Lasix. That's what the doctors do. The patients get admitted into the hospital. They're in there for five days, then they're discharged. When they're discharged, up to half of them are still congested. They still have residual congestion. That's really the opportunity, to intervene prior to that patient getting so sick. That they have so much fluid that they have to be hospitalized to get the IV. If a patient does get hospitalized, when they come out of the hospital, we know they're at danger of being readmitted due to congestion, right there to intervene at the doctor's office to get that patient before they have to bounce back into the hospital. This doesn't happen quickly. You know, this worsening heart failure symptoms really occur over several days. It can have to be weeks. That patient will call the physician's office and say, "Geez, doc, I'm, you know, 3 lbs over my dry weight. I've got swelling in my fingers. I can't get my wedding ring off. I can't get my shoe on. I walked up the stairs, and I was a little short of breath." The doctor has time to intervene right there. Before COVID, he'd probably say, "Hey, let me come on into the office. Let me see you." Now, a lot of this is done kind of over Zoom or over Teams. The doctor has an opportunity to intervene. Right now, what does he do? The only thing he really can do is double the oral and hope that that's enough to start getting the fluid off, get the patient coming back down to their dry weight. They might add like a metolazone, a non-loop diuretic. Got a lot of nasty side effects, but the doctor's doing everything they can to keep that patient from going to get so bad they need the IV, because the only place you can get the IV is in the hospital. If I talked about our intervention windows, there's really two. There's this prevention window, where, as I said, the patient first calls the doctor and says, "I have some, you know, extremity swelling. I'm a little short of breath." Right there, you know, you can use FUROSCIX to get that fluid off predictably and effectively. We know not all docs are gonna, we're not gonna get 100% market share. Some of these patients will be hospitalized. It's when they come out of the hospital, they're all gonna go in for their post-discharge visit, day three, day four, day five. If that patient is still residually congested after spending five days in the hospital, after costing the system $20,000, that doctor is very aggressive in how they treat this patient. We look at this really kind of as the low-hanging fruit at launch because the patient's incredibly motivated. Just spent five days in, starting to feel bad again. The physician's motivated. I just had this patient in for five days. The hospital is going to get a penalty from CMS because CMS has said, "We're seeing too many heart failure-related readmissions." Now they penalize these hospitals for excess readmissions due to heart failure. The hospital wants full beds. They just don't want full beds of heart failure patients. They overstay the DRG, which pays 3.9 days. They're there for five days, and then they bounce back, and the hospital gets penalized. These are the two windows where we can intervene, both before they're hospitalized and then also after they're discharged. How are we gonna stop this problem, or how are we gonna help this problem? It's really with FUROSCIX. FUROSCIX is a drug device combination regulated as a drug. It's indicated for treatment of congestion due to fluid overload in adult patients with class 2 and class 3 heart failure. It's not indicated for emergency situations. If that patient is so sick, so fluid overload, so drowning in their own fluid that they can't even get out of bed, patient needs to go to the hospital. We deliver an 80-mg dose of FUROSCIX. This is the typical dose you'd see IV. We do it over five hours. We do that so we can give a bolus dose in the 1st hour to get the patient diuresing. To optimize our profile, we do an infusion of 12.5 mg delivered every hour for the next four hours. What we were able to do with this profile is achieve bioavailability of 99.6% of the IV and show similar diuresis and natriuresis to IV furosemide. This was the goal. The goal was to find a way to give these patients IV equivalent furosemide outside of the hospital. The infuser we use is a West infuser. It's the same platform Amgen uses for Repatha. I mean, AbbVie uses for SKYRIZI. It's small. It's smaller than a cell phone. All the patient does is drop the cartridge in, peel off the back, put it on their stomach, push the button. Our device, our drug device combo replaces a day in the hospital. We've done all the ADL, activities and daily living work. This doesn't interfere with anything they wanna do. They're heart failure patients, so they're not gonna be on a World Cup soccer team, but they wanna be home. They wanna be with their family. They wanna be with their friends. They wanna be with their pets. They wanna go for a walk. They wanna go to the store. Wearing FUROSCIX allows them to do it and not be hospitalized. We anticipate for every script, there'll be four doses of FUROSCIX. This is totally disposable. They'll put it on. They'll finish their therapy. They'll take it off. They'll throw it away. They'll put another one on this morning, or the next morning. Four FUROSCIX replaces a $20,000 hospital stay for the patient, for the physician, for the system. Here was our pivotal study. It was a PK study. It was a 505(b)(2) approval pathway. As you can see in the orange, this is the PK. This is the IV. You can see those high PK levels. This is pretty much wasted drug. Your kidneys just can't process that much. We look at our profile in the blue. Not only did it match the bioavailability of the IV, we think it's actually a better profile for patients for therapy. This was our pivotal study to get approval, but it's also the main study the physicians wanna see. All the physicians are looking to do here really is to replace the need for IV in the hospital and give them IV equivalent at home, and this study shows that that's exactly what we can do. We also did a HEOR study. I know a lot of people will kinda take some off-put on their, on their main study and create an HEOR story. We went at it the other way. We said, "Let's go right to the payers," and we created a payer ad board to develop the study they wanted to see, which was FREEDOM-HF, where we actually turned these patients around. These patients had tried everything, failed, ended up at the ER, randomized them into the FUROSCIX group, with the primary endpoint of looking at the difference in heart failure-related costs between patients going in the hospital and these patients being treated with FUROSCIX. You saw a difference of $17,000 with a P value of less 0.0001. This didn't include the cost of the drug. four days of therapy would be about $3,300. Even at $16,500, it's a big difference for plans in cost of care versus hospitalizing or using FUROSCIX. This is the data we're going out to the payers with right now, and it's been extremely well-received. To move quickly to the commercial opportunity, I know I don't have a ton of time left. Again, I talked about the 6.7 million patients. There's about four million events, as I spoke to earlier. We think about half of them are addressable with FUROSCIX, about 2.1 million. There will be some that they're acute pulmonary edema, they've just waited too long. That's not our patient. We'll get them on the other side as they're coming out of the hospital. I talked about the average cost at four days of therapy of about $3,300. That equates to about a $6.9 billion addressable market opportunity, with the goal to prevent admissions and readmissions due to congestion. Stakeholders aligned here, this is kind of rare in pharmaceuticals, where obviously the payer, this is a great payer story. It, it costs them, you know, DRG is about $12,000. It's really costing them $15,000-$20,000 to have this patient admitted. By taking that patient and paying $3,300 versus $20,000, it's clear for payers, plus you have all the readmissions. I mentioned hospitals like full beds of knees and hips, not heart failure. These patients overstayed a DRG and bounced back. CMS created that Readmission Reduction Program to penalize these hospitals for high readmissions. Obviously, the physician... Every time a patient needs IV, every time a patient's hospitalized for worsening heart failure due to congestion, it's really a failure of diuretic management. These physicians are motivated to keep these patients. These are our most vulnerable patients. These are patients that even before COVID were going to the hospital, getting nosocomial infections and having bad outcomes. These patients were so afraid of COVID and had such bad outcomes with COVID, a lot of them were just drowning in their fluid and dying at home. The doctors know these are not patients. You can treat them outside of the hospital, treat them outside of the hospital. Obviously the patient wants to be home, wants to feel like they're not, you know, drowning in their own fluid, that they can go for a six-minute walk, that they can go up the stairs without having to stop three times. Really, you have a situation where the stakeholders are aligned. This is some market research we did with our target physicians, heart failure specialists, cardiologists, and heart failure nurse practitioners. This is IV furosemide. This is 100% bioavailable furosemide. They said they're using between 93% and 96% of them said they'd use it. We said, "How quick would you use it?" 86% - 89% said they'd use it within six months. They've been using IV furosemide their entire career. We're just giving them the opportunity to use it quicker, not waiting till they have to be hospitalized, and to be able to use it at home and keep the patients at home. We went one step further and said, "Okay, most of you are gonna use it, 96%. How often are you gonna use it?" We looked in this study, this market research. The clinic-based is really that prevention window, where that patient shows up at your office or the clinic. "What percentage of those patients show up with worsening heart failure due to congestion would you use this on?" They said 65%, so two-thirds of those patients. What percent of those patients that are coming out of the hospital or who have been in the hospital and are danger of readmitting? They said about 50%, which lines up exactly with how many we know are residually congested. Someone always asks me on this, "Why isn't it 100%?" We know the physicians know there are some patients that this isn't appropriate for. If they're no caregiver, they're home alone, they have some level of dementia, that's probably not our patient. When you have 96% of the doctors using it with anywhere to half to two-thirds of their patients in a $7 billion market, it's a sizable opportunity. It's really concentrated. In these top 4 deciles, about 435 hospitals, they have about 40% of all of the discharges, and we really use the hospital as kind of the center of care. It's not a hospital-based product. We don't have to go through P&T. It's really an outpatient product in the docs' offices, in the heart failure clinics. We can cover between 40% and 45% of the opportunity with 40 reps. Our 40 reps right now, well, 39 of them are in Orlando training to be in the market next week. We're launching next week. We can cover 40%, 40%-45% with only 40 reps. We know to get higher, to get to 70%, 75%, we'll probably have to be up to about 125 reps, which is the plan. We'll go there in a couple different, couple different steps. We'll start with about 6,000 healthcare practitioners, about 150 docs per sales rep, calling on about 10 hospitals as well. We're gonna support these reps with all the digital tools you can imagine, from core messaging, positioning, electronic catalog, in-services, websites, banner ads, coming soon ads, we're everywhere. We're at Heart Failure Society of America, we're in ACC. We're really using digital tools, which really are a real efficient way to get to physicians and nurses to support the direct selling effort in the field. From a payer standpoint, this is 75% Medicare, and about 10% commercial, 10% Medicaid. We know within Medicare that about 60% of the total patients will have fixed-tier co-pays of $100 or less. Within that, more than half of them will have fixed-tier co-pays at $10. You have a very large contingent of low-income subsidies, dual eligibles within Medicare. Up to 40% of heart failure patients, in Medicare have fixed-tier co-pays of $10. We're gonna continue to work on this. The goal is to get to 75% of all patients with fixed-tier co-pays by the end of the year. Distribution, specialty pharmacy through a hub. We have a patient support hub. There's live support and training. There's online videos. There's instruction for use that comes with FUROSCIX. There's patient videos, physician videos. There's home support, as needed. We don't think that'll be needed. There's an 800 number the patient can call if they have any questions. We'll be in-servicing all of the offices to make sure that they know how to use it appropriately and to teach the patients, but we'll surround the patients with support. Very simple to use FUROSCIX. Again, it's the same platform Amgen uses. We did human factors. In all the use tasks, 99.6% were completed successfully. We also have reimbursement support through the hub. Our distribution strategy, we go right to a 3PL, and then right to specialty pharmacies that will deliver it directly to the patient's house. A lot of these patients use public transportation, ride-sharing. The best distribution model is to get it to them next day, same day in some cases in some MSAs, but we're really trying to get the patient where the patient is, and that'll be at the patient's house. That's really quickly the company's story. Again, really excited. We're gonna be launching, we said next week, FUROSCIX. Just a clear value proposition, established reimbursement model, great IP. It's a drug device combo, hard to knock off anyways, but we have IP on our drug to 2034, on the device to 2035, on a real strong cash position with cash really into 2025. That's the story, Roanna, as quick as I can do it. Great. Yeah, thanks for the good overview. We have a couple minutes left, so I'll start with a common investor question that I've been getting recently. What are your uptake expectations in the first few months of the FUROSCIX launch? Could you remind us what strategies your field force will use to engage the different physicians and stakeholders out of the gate? Yeah, you know, we think that coming out of the gate, the best strategy early is kind of paint the picture of a patient and to really probe into a patient. There's a lot of physicians we've heard from already that know exactly where they're gonna use it. They say, "I'm gonna use it on this patient, this patient, this patient." We think painting the picture of that patient that's just been discharged from the hospital and shows up in your office with residual congestion, desperate to stay out of the hospital, is really where we're gonna target initially. We've had some heartbreaking phone calls into our 800 line from patients saying, "I've been in the hospital five times in the last year. Is there compassionate use? Is there anything? We really think those patients at first is where we'll have early experience. As far as, you know, guidance, you know, if you look at where kind of the consensus is around, I think around $15 million for this year. Obviously, that'll ramp a little bit as we go through the year. You know, we haven't given guidance. We feel comfortable that we can hit those numbers. No sense bringing that guidance up. You know, it... We don't think it'll be a hockey stick because, you know, with new chemical entities, a lot of times a doctor will try something on one patient, wait three, four, five months to see how it worked. This is an acute intervention. They're going to know if it works immediately. They've been using IV strength furosemide their entire career. We think it's gonna be more of a, kind of a linear launch. We feel, you know, with the 40 reps out there now, getting around to see all the physicians within the next month or so, really starting to drive utilization in Q2, Q3, and Q4. Got it. Yeah, super helpful. Could you remind the audience, what launch metrics do you plan to share for FUROSCIX over time, and which ones do you think are the most important for investors to focus on? You know, internally, we look at, and this might not be that interesting to investors, but how many in-services we're doing. These aren't just walking in and saying, "Hey, here's a demo device. Go have fun." We really think it's important that our MSLs and our reps are in these offices showing them and talking to them what patients are, appropriate patients are, and how appropriately to use FUROSCIX. That's a key metric where we're doing formal in-services with more than three or four people within the office. Looking at the average length of scripts, we will be recommending 4. We think there are some doctors that might do more, and some doctors early that might do less. We'll be looking at that. We'll also be in communicating, how many different Offices or clinics that have prescribed at least one patient with FUROSCIX, and then, how many physicians have done at least two. Those are some of the metrics we'll be communicating. Got it. Interesting. I know we're up on time, so my last question, wanted to check in about the recent payer determinations for FUROSCIX and how many remaining large payers still need to make decisions on FUROSCIX probably at the beginning of the launch or in the next couple months? Yeah. We're gonna have some that are waiting for the launch. We've gone through the big payers and gone through P&T, and all of them except one with favorable P&T. We have one that still has not done P&T, that's scheduled for next month. From a clinical standpoint, we've gone favorably through all P&Ts. With a number of the plans we're still negotiating, you know, at the, call it the value assessment committee, where the rebates are negotiated. We know coming out of the gate, because of Medicare Advantage and because of LIS, that about 60% of the patients will have a fixed-tier copay of $100 or less right out of the gate before we even discount. Our goal is to have 75% of patients by the end of the year on fixed-tier copays, and then to have that fixed-tier copay down to around $50. If you look at Medicaid will be covering this right out of the bat. It's about 10% of the patient with about a $10 copay. Where we're not on formulary, and there will be some formulary wins we might announce a little later, we'll coupon them down. With Medicare, about 60% of Medicare will be fixed-tier copays right off the bat. We're still negotiating in that value assessment committee with a number of the big payers right now. Great. Yeah. Thanks for the recap. I think we are at time, a tiny bit over, but thanks for staying on, and appreciate the time, John. We loved walking through the company, and I just wanna thank everyone for joining, and hope you have a good rest of the conference. Great. Thank you so much. Appreciate it.