Thanks for joining us at the Leerink Partners Global Healthcare Conference. My name's Nik Gasic. I'm one of the VPs here in Equity Research. It's a pleasure to have scPharmaceuticals here with us today. I'm joined by President and CEO of the company, John Tucker. John, welcome. It's great to see you. Thanks, Nik. Thanks for having us. Absolutely. I guess we can kick it off with some bigger picture questions and then maybe dig a bit deeper into the story from there. I guess for investors who are newer to the name, could you give us a quick overview of the company and highlight some of the differentiating features of your lead product, FUROSCIX? Yeah, sure. scPharmaceuticals is really focused on driving care from the highest cost setting, which is the hospital with the worst outcomes, really, to the lowest cost setting of care with preferred outcomes, which is the home. Our lead drug is a drug called FUROSCIX. It's a drug-device combination that actually takes IV furosemide, and we've reformulated it, created a patent estate, and delivered it subcutaneously by an on-body infuser that allows patients to diurese at home as opposed to in the hospital. A patient on oral furosemide will have an episode where they have worsening heart failure. The bioavailability of their oral will go down. They need 100% bioavailable furosemide. Really, in the United States, before FUROSCIX, the only place to get that was really in a hospital, either be admitted, maybe in an IV lab. Now we can deliver that same level of safety and efficacy at home in the patient's home. Got it. That's a very helpful overview. I guess we're in 2025 now. I guess what are some of the top clinical, maybe regulatory, or commercial priorities for the year? What are some of the big catalysts investors should be watching for this year? Yeah, so one of our big ones was actually last Thursday. We announced that we had approval of edema caused by chronic kidney disease. So expanded our label now. We have heart failure, edema from heart failure, and edema from chronic kidney disease. As you know, the heart and the kidney work kind of in tandem. This opens up a whole nother book of business for us. About 700,000 patients have edema from chronic kidney disease that do not have heart failure. They really haven't had an option. We've had some nephrologists attempt to write it for kidney, and it was off-label. We're really excited about the launch in nephrology, which we will have in our launch meeting next month, mid-April, and then be launching to nephrology. We'll have cardiology and nephrology call point. We also expanded our sales force in Q4. I think we're starting to see some of the benefits of the expanded sales force allow us to have higher frequency on some of the bigger heart failure accounts and now heart failure clinic accounts and now into those big nephrology offices, as well as continue to service the cardiology population. We also think the Medicare redesign is a tailwind at our back. I know for some companies, it's more of a headwind. For us, having to pay the mandatory rebate, though, really gives access to more patients that can be affordable. If you remember the Medicare redesign, it really lowered patients' out-of-pocket caps to $2,000 from really what was about $4,000 last year. That really will allow more patients to have access to FUROSCIX at an affordable copay. The expansion of the sales force, the expansion of the label, the Medicare redesign, and then another catalyst for us, not commercial this year, will be filing our NDA for our auto injector. Our current product, which I might add, has had tremendous response in the field from patients and physicians on how well it's working, how fast it's working, and maybe most importantly, how predictable it works. It works every time. It's 100% bioavailable furosemide. We have had amazing feedback. Our auto injector, which again, we'll be hoping to file mid-year this year, takes our COGS down by about 70%-75%, but also, probably more importantly, gives patients and physicians another option in treating their worsening heart failure. Very convenient. It's a two-second push. We hope to have that filed mid this year and on the market first half of next year. Got it. That's a solid overview. Lots to look forward to. Great answer. I want to zero in on heart failure for a second. Maybe could you remind us of some of the key aspects of FUROSCIX label? What types of patients is it approved in? Who's the most likely to get the most benefit from FUROSCIX right now? When we initially received our approval, it was for New York Heart Association Class II and Class III heart failure. Doctors could not write it for Class IV, which tend to be the sicker patients or what the doctors call them frequent flyers that are in and out of the hospital maybe six, eight, ten times a year. We launched in Class II and Class III heart failure. We added the expansion to Class IV heart failure in August of last year of 2024. Actually, what happened is by adding Class IV, we took all of the classifications off of the label. Now it is indicated for heart failure and for chronic kidney disease. These Class IV patients, I know you always think of them as the patients waiting for heart transplants. Probably half of them are in a position where they're not really candidates for FUROSCIX, but the other half are. Again, these are patients that could be palliative care patients that are coming into an IV clinic two or three times a week, or they could be patients that are kind of considered frequent flyers where they're being hospitalized every month or every other month. We launched in Class IV really in September. We've already seen an impact not just in how many scripts are being written, the length of the script. These are longer scripts because they're sicker patients. Again, there's some palliative care, so you'll see a doctor write for a month at a time and maybe write 12 units. It is also given us access into more of the heart failure clinics where more of these patients are, where when we did not have that indication, it was really a struggle sometimes to get in and see some of these physicians. Got it. No, that's very helpful. I think you pre-announced full year revenues for FUROSCIX, about $36 million or so. I guess looking ahead in 2025, what are some of the key growth drivers for the trajectory from here? And how do you expect the year to shape up? Yeah, so we pre-announced back in January, we did do a little over $36 million. We saw really nice growth in the second half of the year. Just units, I mean, units shipped went up 24% from Q3 to Q4. We have continued to see increasing unit shipped quarter over quarter. We anticipate seeing that obviously accelerate into this year. The key growth drivers, as I spoke about, really having that expanded sales force. We really did not feel the benefit of it until probably early this year. Having the expanded sales force, the kidney indication, the Class IV all year, and then again, the Medicare redesign. I understand you are going to take a little GTN hit here because you are going to have a mandatory rebate. Having all of those Medicare patients with access to affordable copays for us, and not everyone's going to look at it the same way, but for us, that's a giant growth driver for us this year. For sure. I want to dig into that Part D update from a volume standpoint. I guess could you remind us what the current coverage split is for FUROSCIX right now? Yeah, about 70%-75% of our patients are Medicare patients. Now within Medicare, that's split pretty evenly, 50/50 between Advantage patients and patients in strict PDP. The balance of it is split pretty evenly between Medicaid. With Medicaid, we have coverage in every state with copays typically at $8, maybe up to $12. The other 15% or so are in commercial. In commercial, we're preferred formulary at United Optum with a $60 copay. We can copay coupon them down to make sure everyone has an affordable copay. That's the key thing. If you ever go to any of the RA Capital seminars about no patient left behind, it's really about making these products affordable to patients. It's great to have this therapy that keeps them out of the hospital. If the PBMs and the plans make the copay so high that it doesn't allow a patient to access it, it doesn't make any sense. That is where we are. With Medicare, again, this year things have changed. In Q1, everyone still has their deductible, which is $550. Patients had the option this year in Medicare to sign up for something called smoothing, which was taking that total $2,000 out of pocket and really spreading it evenly over 12 months. $166 copay each month. Now, CMS had estimated that 70% of the patients would sign up for smoothing. I think this got off to a little bit of a choppy start, listening to what CMS is saying, what we are seeing. There have not been as many patients as we thought would be on the smoothing. That is one of the three components with the smoothing. The bigger component is the $2,000 out of pocket. And these are heart failure patients. Last year, again, was closer to $4,000. There was a hard cap and a soft cap. That's all gone with just a $2,000 hard cap now. These patients will get through that, heart failure patients, probably in April, May timeframe. And then again, it is $0 copays. We have seen over the course of the two years for us, when that patient copay goes down to under $100 a month or $100 a script, is where our fill rate goes up dramatically. We actually see the doctors kind of follow. It's almost a halo effect of when their patients can get this at an affordable copay, they tend to write more and more. We really think, yes, we'll take a little hit on the GTN, especially here in the first quarter, but that once these patients get to that out-of-pocket cap, that we're going to see a big increase, not just in what's filled, but also what's written. Got it. Yeah, I guess you expect an uptick in volume around April or May as well. I think you'll see an uptick in volume. In the first quarter, you've got to offset that with the increase in the GTN. Clearly, when the patients get to these lower copays, we saw it last year with some of these foundations when I know Coca-Cola wrote a giant grant to a heart failure foundation. We saw immediate impact on our business. We know what happens when copays go down. We just decided not to play the game with the PBMs of massive, massive discounts when we launched. We did it a little bit the hard way, but we really think this redesign really positively impacts us. For sure. Maybe on that note, I guess where's gross to net at today and where do you see it going over the next year or so? When we pre-announced Q4, we said it was in the 18%-19% range. It's going up. It has to. We think this quarter, Q1, what kind of guidance we've given is 25%-30%, probably the same for next quarter as the first stage of the initial phase of Medicare is a 10% rebate. Then it goes to 20% when the patient gets to catastrophic, 20% for us. That probably leaves us with an exit GTN of about 35%. If you kind of smooth the year, we're thinking around 30% for the year. Again, I've looked at other companies that have reported and have said that the redesign is a bit of a headwind form on net sales. It's true. I saw one company that said their GTN is going up to 75%-80%. The important thing to keep in mind, most likely that company was paying 55% to be on preferred. So while they're not getting any more access, they're not getting any more low copays, they're just paying the rebate. We're not in that position. We're really adding significantly to the number of patients that can afford a copay for FUROSCIX. Got it. That's super helpful. I guess just what have you been hearing from the field in terms of patient out-of-pocket costs? Have these been more manageable lately? What's the feedback been? It's been really interesting to watch. Again, on October 15th of last year, CMS said they're going to go out and identify these patients that are going to hit their caps based on what had happened last year for these patients, and then sign them up in the smoothing program to better manage that out-of-pocket, that $2,000 out-of-pocket. We have seen some patients when January 1 came about that had smoothed. You could tell they had smoothed just by if it's January 2nd and someone has a $0 copay in Medicare, they elected smoothing. There's no way they would have gotten to the cap already. Again, not as many patients as I think CMS anticipated had been in there. We did see, especially in January, a number of large copays, $2,000 copays out of pocket. That's moderated a bit as patients because every time you fill anything, it comes off of that $2,000 cap. We're starting to see the copays go down and see more and more smoothing. I think that will continue really as we get, as I said, with heart failure patients, we anticipate them being through the cap April-ish, May timeframe. That's where you see the real acceleration of copays at $0 across the board. For sure. Maybe a good segue. I think you also mentioned that you expanded some of your specialty pharmacy distribution channels recently. I'm curious, what sort of impact is that having on the trajectory so far this year? How are you thinking about future expansion on that front? Yeah, we launched initially with two specialty pharmacies. We added a third one that is really focused on Medicaid and one that has courier service actually to the large MSAs in the country. Now a script can come in adjudicated, can go out immediately by courier service. We made a brand promise that we were going to meet the patients where they are. These are heart failure patients. A lot of them don't drive. Rideshare, kid gives them a ride, public transportation. We said we're going to have a distribution model that we can get it right to the patient's home. We know during COVID and immediately post-COVID, patients were doing a lot of telemed with doctors. Now, the doctors still want to see the patients. They want to put their hands on a heart failure patient. Really, where the brand proposition is, boy, you call that doctor and say, "Hey, I'm 10 pounds over my dry weight, a little short of breath walking up the stairs. My fingers, my feet are swollen. Okay, double your oral, Mrs. Jones, right now. And I'm ordering FUROSCIX, and it'll be there tomorrow. It'll be there the next day. Still want you to come in, but we're going to put the FUROSCIX right there." You can only do that by really meeting those patients where they are. That is why we chose the distribution network. Now, we've expanded and have been really focused on growing our IDN presence. We've put a new team out there just really calling on IDNs. The IDN business is hard. In a lot of ways, it's slow. It's like getting a drug on a hospital formulary in the old days, going through P&T. You have to really work kind of top down and bottom up. You want to engage with the plan administrator, the pharmacist, the head of the clinic. If you don't have underlying demand, then there's no reason to do anything with an IDN. We've been really driving the underlying demand within these IDNs. The advantage of the IDN for us, A, it's a lower distribution cost for us than going through our specialty pharmacies. B, it removes friction from the script, from a doctor writing. If it's in his own pharmacy, it's in his own EMR or whatever, they can write it much easier. We also see with this distribution model that we're seeing more usage kind of post-IV. When a patient is hospitalized, they receive two doses, and then, boy, our two doses of IV, boy, we can send them home with FUROSCIX and kind of finish the diuresis job. You can really, it's hard to do that in a community hospital where there's a hospitalist and maybe the cardiologist is involved, but you got to worry about discharge. With an IDN, that's so much more seamless. We are seeing a big increase in our IDN distribution model and with our IDN sales. We think that's going to continue. We'll keep with the three SPs. We have direct relationships now with Kaiser, Geisinger, signed Cleveland Clinic. We will be also expanding into the VA this year as well, the direct model. Got it. Maybe just on the IDN point, if we could drill deeper a little bit, how do you expect new, or I guess maybe the existing IDN agreements to sort of drive growth for FUROSCIX in 2025? Is it a meaningful contributor or? It's becoming more and more meaningful every quarter. I think we've said it could be 20%, 25% of the business. I think it can be significantly higher than that. Now, some of it does cannibalize your existing business because, as I said, you need underlying demand to really bring the IDNs to the table. We're seeing we're implementing pull-through programs every time we have one of these relationships. Every IDN is different in how much influence they have. Obviously, Kaiser can really push things for you. Other ones are a little bit, hey, we have it. We'll let the doctors know. It's always a good thing for the rep to be able, when they're detailing the physician, to say, hey, we're in your pharmacy. We're in the IDN. You can order this really easy. There's a kind of a blessing on the therapy, if I will, when you're actually kind of on contract in the pharmacies, working with the plan. One thing we've spent a lot of time on in the last six to nine months is developing protocols, having them blessed, and then being able to send out protocols to new IDNs on what so-and-so IDN is doing. With Kaiser, we have an initiative they've undertaken. They're doing actually a study with their home healthcare nurses. We've educated all of them. When that patient gets home, you want to keep him home from the hospital. How are we going to keep him home? You can use FUROSCIX to do that. We really think all of those things are really what's going to drive. It's not just about getting an IDN contract. It's really about pulling the product through, using protocols, working with the IDN and the physicians to start establishing protocols, pre-admission, post-discharge. I'd love one day to be in the ER Now, it's difficult. Again, in a community hospital ER a patient comes in with worsening heart failure. That doc probably doesn't want to be the last name on that chart. The path of least resistance is just admit him into the hospital. With an IDN model, you can think of that a little differently. You can give them a dose of FUROSCIX while they're in the see how they respond, see if they stabilize, send them home with four or five FUROSCIX. Maybe even eat the cost of that if you want to admit them in the ER receive the DRG, send them home with FUROSCIX. Medicare pays for it. Great. If they don't, you still made money. It's just a lot of different things you can do within a closed network. For sure. Maybe pivoting a little bit to CKD and that approval there. You mentioned you just recently got that. How does this indication expansion fit within your broader vision for FUROSCIX, just the company overall? Yeah, with the company, we really look at the cardiorenal space as where we want to be. Again, the heart and the kidney are so intertwined. In fact, we fought really hard with the FDA on the label for CKD, and we ended up with a wonderful label, very expansive, no restrictions. They wanted to kind of separate the indications. We talked to a lot of nephrologists who had said, "I don't even know sometimes this patient has heart failure or I just know they have fluid overload and I have to deal with it." We were able with the FDA to get a broad label that is for edema caused by kidney disease or cardiovascular heart failure, including the nephrotic syndrome. We have the really broad label, but it's part of kind of where we want to be is really in that cardiorenal space. That's really the vision for the company, really looking at kind of innovative patient-centric care in the cardiorenal space. Got it. That's a helpful overview. I guess how large of a product do you think FUROSCIX could be in CKD relative to heart failure? I guess where do you see penetration in the CKD shaping up over the next couple of years? It's interesting. We know that there are nephrologists that are treating heart failure, edema from heart failure with or without CKD. They're already doing it. They have a relationship with the cardiologist. You think kind of a rank-and-file cardiologist, not really talking about heart failure clinics, but rank-and-file cardiologist sees a lot of different things in a day. A nephrologist deals with fluid. That's what they do. They're kind of more comfortable even with dosing. They're much more aggressive on dosing. What we've heard is they'd use FUROSCIX and keep them on their oral and add FUROSCIX to it. They talk a lot about, "I got to get this patient dry. I got to get this patient dry," which is a little different than how when you talk to a cardiologist about how they think about it. If you actually look at the profile of a nephrologist versus a cardiologist, and I'll take the heart failure specialist out of this for a minute, they're actually writing more diuretics than even a cardiologist. They use a lot of non-loop diuretics like metolazone, which has kind of an interesting safety profile. We really think we don't think of it as this much in kidney and this much in heart failure. We think about this much coming from nephrology and this much coming from cardiology. It's about 35%-40% coming from nephrology. That was a long answer to your question, but about 35%-40%. We know there's 700,000 patients, as I mentioned before, that have edema, and this is pre-dialysis, have edema caused by kidney disease that do not have heart failure at all. Got it. No, that's very helpful. I guess any learnings from the heart failure launch, which you could apply to the CKD launch? So many. I mean, so many learnings. It goes all the way from targeting, like what's the best way to target a physician? This isn't like your typical oral product where we know how much every doc writes. We know what he writes. This is creating a market. And what we thought, we just thought, boy, anyone who writes a lot of loop diuretics, that's our target. That's it. That's how we're definitely going to help. That is not the right way to do it. There was a lot of trial and error when we first launched just around targeting a physician. There is an affiliation with a heart failure clinic. What does that mean? We have those learnings around how to target nephrology. I think we've also done, we did a lot of market research in heart failure. We've probably done more, more targeted research because we understand the questions to ask better. I can give you an example. We did an awareness trial and usage baseline before the cardiology launch. I think it was about 10% awareness of unaided awareness of FUROSCIX. It's 31% in nephrology prior to launch. The hub, we did change out hubs. I think you know that. Remember that was painful. It's always painful as hell when you change out a hub. Ours was as painful as hell. We've got a better hub. We got a hub that can handle the volume, a hub that can reach patients. You would think a symptomatic patient would pick up a phone call because I'm waiting for this drug. They don't. Again, these are usually elderly patients. See a number they don't recognize, they don't pick it up. Texting them, calling them, FedEx a letter to them because it's getting to that patient. Now, you can educate the physician, make sure the patient knows we're going to call. It's all of these things in the hub, removing the friction, even from if they need any clinical notes, how to set that up. Our new portal is so much easier for doctors to use. It's just in-services, how we used to in-service. We've now found a way to be way more efficient, which allows us to make more calls, more frequency, more reach. I think it's all of those things that we feel comfortable that we're going to have a quicker uptake in nephrology than we did in cardiology. For sure. You mentioned you expanded the sales force in heart failure last year. I guess how are you thinking about future expansions around the CKD launch? How many reps would you add ultimately from where you're at right now? Yeah, this has evolved a bit, maybe even since we last spoke. We've always said we probably need to get to about 125. 120-125 is the total number to service both indications. I think we've always been leaning to kind of combine them so the reps have two call points. We cut territories, and it's pretty clear that these nephrology territories look very different than a cardiology-only territory. I think our thinking now is we might actually have a kind of a specially nephrology sales force that will call on nephrologists of about 30 people. We're still looking at territories. We'll continue to expand our key accounts who will call on the IDNs. They're not national account managers that go in and do a contract. They do that, but they have to pull it through. They're working with physicians. They're coordinating with our reps to pull it through. That's where we think the eventual size will be about 120-125 reps. Got it. That's super helpful. Maybe in the last minute or so, I just wanted to ask, current cash position runway from here. I know you did a big financing last year. How are you planning to allocate that capital across commercial expansion, the pipeline, the auto injector, etc.? Yeah. The vast majority has been spent on commercial. We did the raise. We said, based on our operating plan, this will get us to profitability. We're still saying that this gets us to profitability. Now, the vast majority will be spent commercially. You're going to have 100 or so reps out there. That's going to cost $37 million-$40 million a year. Our R&D, we're probably looking at $2.5 million-$3 million a quarter on that. We want to stay opportunistic. We're looking at, we're bringing on a 40 milligram dose. So we'll have an 80 milligram in the auto injector, a 40 milligram on the auto injector. We're looking to do a dial-a-dose where a patient can actually, after the physician's instructions, could maybe click once, click twice, click three times. This is really about dose flexibility that's really coming from the nephrologist on dose flexibility. That's really, it's going to be more on the commercial, but we're going to continue to invest in the R&D. Got it. Maybe just a quick question on the auto injector. When do you expect that to come online? We expect to file it mid this year and then have it in the first, launch it in the first half of next year. Got it. Just in the last 30 seconds, I don't know if the audience had any questions. Feel free to jump in. I can keep rolling. I guess beyond heart failure, beyond CKD, what other indications or therapeutic areas are you expecting? We think we can expand the current label into liver disease. We still think there's a market for a subcutaneous beta-lactam antibiotic. Ceftriaxone is the most broad spectrum, probably the one that would be best. They come with a lot of challenges from patient reconstitution, which we don't love because there's not really technology to do that. I think we'd be really starting to look harder at taking that forward. We've done clinical work on that. We've met with the FDA a number of times. There's clearly an unmet need in an IV strength, anti-infective broad spectrum with gram-negative coverage that would have a big appetite in the market. I think that's something that we're going to continue to try and advance. Super interesting. I think we're all out of time here, but John, always a pleasure. Thanks for joining us. Thanks. I appreciate it.