We're nearing the end of when I can say good morning to everyone, but thanks so much for joining us at our 45th Annual Healthcare Conference. I'm Stacy Ku, one of the biotech analysts. I'm here with my colleague, Vishal, and we're very happy to be hosting scPharma's CEO, John Tucker, and also in the crowd, thanks so much to Kate. Very briefly to start, obviously you've given a bit of an overview as we think about FUROSCIX in 2024, but before we get into those details, it's been about a year into the FUROSCIX launch. You all have been very proactive about talking through kind of the wheelings and dealings of the infrastructure that you've really focused on and trying to grow the product. KOL feedback has always been remarkably positive. Just talk about your major learnings and what's been most encouraging. Yeah, thank you first for hosting us. Yeah, you know, first and foremost, how the product is performing in the field. I mean, you know, everyone's done their KOL checks. The drug works, and still the most important thing is how fast patients are having relief. We hear within sometimes 30 minutes, patients who've been struggling with fluid overload for some of them for years are feeling better. Universally, patient testimonial, patient feedback, physician feedback of how well the product works, how consistent the product works, and how fast the product works. I mean, we're looking at patients that are coming back for second, third, fourth courses of treatment, and it's a huge percent. Now, you don't want it to be too big because that means you're not still growing, but it's been really, really remarkable. The learnings from when we launched to now are tremendous. We're still seeing probably 75% of our usage kind of pre-hospitalization where the patient is having fluid overload. They come in to see the doctor, call the doctor, and the doctor's prescribing it. As we go more and more into the IDN market, which has been a big focus of ours, we're seeing more and more use. They call it post-IV, post-hospitalization, really either to get the patient out of the hospital quicker. Maybe they've been in there for two days. They can give them three doses of FUROSCIX, kind of finish the job at home. Kaiser Permanente just implemented, as part of their protocol, all home health nurses now are detailed and are using FUROSCIX in the patients at home. Home health, especially in IDN, makes a lot of sense. Those are some of the learnings. We've also learned better how to service the patients and the physicians. We changed our hub. Always a hard thing to do. We did it to increase patient satisfaction, physician satisfaction. We're seeing more and more docs now on e-prescribing, which again removes the friction. That is part of the IDN strategy. We've learned how to be more efficient doing in-services. It used to take us half a day to do them. We can now do them in an hour. Just so many learnings. Okay, wonderful. Again, to your point, our consultants do tell us that the FUROSCIX target market is kind of easily identifiable. They know these patients well. They tend to be high flyers and a touch more severe, which kind of does lead to our next question, which is how is the ongoing expansion to Class IV? Yeah, so in Class IV, so it's about 10% of the patients, roughly 10% of the patients, but they're the highest need patients. We're seeing in Q4, we haven't put this out there yet, but it'll be more than 10% of our patients will be Class IV. Also, their script sizes are larger. When you see a Class II or Class III patient, it's probably four or five units. The Class IV patients can be 12 units. Our average units will go up to probably six or seven this last quarter. That's driven primarily by Class IV patients. Okay, where do you think the split could evolve over time as we think about Class IV versus some of the other kind of less severe patients? The Class IV patients tend to be at heart failure clinics, not in kind of rank and file cardiology. Heart failure clinics tend to be more affiliated with IDN. Part of the IDN strategy is around the heart failure clinics. We think over time the Class IV patients, now we're not going to have all the data because with the IDNs, the issue with the IDNs, you don't get the data to break it out by Class II, Class III, Class IV. We think it's 25% at the end of the day. I think about 25% of the patients will be Class IV. Okay, understood. One thing that you all have commented on in the past is as you try to reach out to more and more heart failure specialists, that Class IV addition, is that helping you all in terms of your outreach? Yeah, so when we go into heart failure clinics without the Class IV indication, we originally, right when we launched, docs were writing Class IV scripts and they were getting bounced back. They were not covered. It was on the label. And so we kind of had to pull back a bit from the heart failure clinics because a lot of their patients are Class IV. They're concentrated there. What the Class IV has allowed us to do is really go into these clinics and be able to detail them. Yeah, it's given us access into clinics. Okay, any additional commentary? I know we're ahead of earnings, so. Yeah, I think one thing that we've really been focusing on is really expanding the use case, not just pre-approval, post-approval, but don't wait till the very end, right before the ambulance is coming to prescribe FUROSCIX. A, it narrows your market. B, any friction in getting the script, you're going to have a patient that doesn't get FUROSCIX, ends up in the hospital. We published some data in October that our at-home study that really showed that if you treat these patients when they first start having issues with fluid overload, when that oral first stops working, instead of doubling the oral, instead of doing all these other things, 37% reduction in hospitalizations. The dyspnea scores at day one, day three, day seven, all were dramatically lower. That really helps us in convincing these physicians. Don't wait. Get these patients feeling better. Don't wait till they are so sick they have to go to the hospital. I think we have been really successful in doing that. That is really an opportunity for growth moving forward. Okay, and of course, the KOL feedback has always been remarkably consistent, very positive. Of course, you all have really been explicit in how much time you're investing into setting up the infrastructure and obviously working through some of the issues that you're seeing in real time. Maybe talk about that. You alluded to the kind of the hub. It's up now and running. You're doing some more e-prescribing, but are clinicians now able to get a sense of which patients are covered? Are you now working on the copay dynamics? Obviously, these are patients that they want to prescribe FUROSCIX to multiple times a year. Just maybe talk through some of those dynamics. Yeah, so our patients are about 70-75% Medicare and then probably 15% commercial, 10% Medicaid. Medicare, there's two books of business. There's Medicare Advantage where our patients have $100 or lower copays. Then there's kind of traditional PDP, prescription drug plan, which is where they tend to have high out-of-pockets, right? That's a bit of a headwind for us, right? If a patient has a $2,000 copay, there's a good chance we're not going to get that patient. Now, a big change this year is the Medicare redesign where patients' out-of-pockets now, their max is $2,000. Last year, everyone said the cap was $3,250, it was really $4,000. Medicare has cut their out-of-pockets in half to $2,000. That's massive for us. Now everyone says, well, how about your GTN? Yeah, the GTN will go up. It's going to go up 10% in the initial phase, 20%. Our GTN in 2024 was around 18%. We think that we haven't had to discount. Now we have to because of the mandatory, but the access to these patients. We see anytime the patients have low copays, such as what we saw in December, that our fill rate goes up to about 60%. More importantly, there's like a halo effect. Doctors will write more if they know their patients can receive it. If a doctor doesn't think a patient can afford it, they won't write it. They won't recommend it to their patient. What we're going to see this year are patient copays on the PDP side go down eventually to zero after they get through their out-of-pocket. We're real excited about how the redesign is going to impact us. Okay, wonderful. Obviously, I'm sure heads down still focused on heart failure and Class IV, but March 6th is tomorrow, Thursday. We do expect a decision as it relates to CKD, so chronic kidney disease. Just maybe talk about to the extent that you can, level of readiness, timing of launch, and we'll get into some additional questions. We feel good about it. We are preparing for launch. We have a launch meeting scheduled if we receive approval next month, mid-April, to get all the reps trained, the new promotional pieces, all of that. We have done all of our market research. We have engaged KOLs. We have identified the key nephrology networks. They are very network-oriented. We are already talking to the networks. We have right now a heart failure indication. If a nephrologist is taking care of a patient with edema caused by heart failure and chronic kidney disease, that is on label. We have been in there already to the biggest practices, in-servicing them, getting ready. We did our ATU study, awareness, trial, and usage. We did a baseline prior to the heart failure launch. We did a baseline prior to the kidney launch. It is about threefold the awareness already in nephrology. We'll have the marketing material done. We've done the KOLs. We have our speakers' deck ready to go. We'll hopefully receive the PI tomorrow with the approval, hopefully be in the field Monday with the PI detailing, and then full launch coming out of our launch meeting in April. Okay, and it sounds like there's going to be a similar focus on the in-person training, making sure nephrologists are able to use the product. We'll need to do that as well. We'll need to set them up. We'll do the in-services. We'll set them up on the FUROSCIX Direct. They're very IDN-focused as well. We will be working with their IDNs if we're not already in there so they can prescribe through their pharmacy and their IDN. Okay, wonderful. I understand that the current sales force outreach to nephrologists is for patients that have concomitant heart failure and CKD. What early learnings are you gleaning from these interactions? What are common questions that the sales force is getting from clinicians? It's the same product and the messaging is pretty similar, but there are some big differences. Nephrologists pretty much deal with fluid all day. It's what they're doing. They're more aggressive in how they're treating. They're not as worried about a high dose or an 80 milligram, 100% bioavailable dose. That doesn't scare them at all. They think in terms of really the big difference is drying them out. You don't hear that from a cardiologist, "I'm going to dry them all the way out." You hear it from nephrologists. "I got to dry them out. I got to dry them out. I got to dry them out." We're pre-dialysis, but they want to get them dry. The best way to get a patient with edema dry is FUROSCIX. They also don't have access to ID clinics as much as cardiologists do. They do do some of that, but they have to use the hospital really for IV. The fact that they want to dry them out, the fact that FUROSCIX is 100% bioavailable, we think the messaging for the nephrologist is even a little cleaner. Okay, and is it a similar emergent type of scenario when a patient comes and needs to kind of get some type of Lasix, IV Lasix or FUROSCIX? It'll be for those patients. Again, we need it to be for more than just those patients. When a patient, regardless if they have heart failure or chronic kidney disease, if they're having a reduced responsiveness to an oral diuretic, you can double the orals and hope, or you can go with something fast, predictable that you know is going to work. We are going to try to move that up, not just emergent in kidney disease, but as soon as they see some diuretic resistance. Okay, what additional level of education, you kind of alluded to it a little bit, do you think is necessary? There's a lot of different, there's a diversity in nephrologists and prescribing habits and maybe even ages. Just help us understand how you're thinking about that. Yeah, it is different from what we've seen in the market research. Market research is market research, so take it with a grain of salt. I think when we started doing the market research, we understood that protocol guideline development. We've actually worked with a couple of major nephrology practices, group practices and networks to create guidelines and protocols. Now, to be compliant, it has to be request in, but we'll send them the protocols that other nephrology practices are using. Really for that understanding, that education on how and why to use a FUROSCIX. That's been a big initiative for us. Okay, and you all, do you have plans to do anything like a registry study or any additional information that could be helpful? Yeah, a registry study is something we're definitely planning on doing in both heart failure and kidney disease. There's a lot of things you can do with that from publications to creating data. We're also doing a number of investigator sponsored studies now. The Kaiser one obviously is a huge one. That's not really an ISS because they're buying commercial drug, but they'll be publishing the results of their home health initiative. There's the ISSs we're doing and eventually a registry study as well. Okay, and remind us potential number of regions that you would need to target for nephrology versus cardiology or heart failure. Yeah, regions. Yeah, it's a national launch. We have 90 reps right now. We're in every major market. We're opening Puerto Rico this month, which will probably be our biggest heart failure territory. We're pretty excited about that. It takes a long time, but we've got that done. We'll be nationally. We are also expanding our key account group, which our IDN use has really exploded here in the last couple of quarters. We think that we're getting in these contracts, we're getting stocking, and now we're going to use that to really pull it through. Nephrology is a big part of that. Okay, just because you brought it up, and we do want to kind of talk about the big picture for CKD. For IDNs, are you expecting that to accelerate? Are you expecting that to grow? That's going to be kind of a major contributor for you all? It will be. It kind of makes sense, right? When you look at kind of the Medicare market, and we focus a lot on Medicare, obviously, you have the PBMs that are the gatekeepers and they want huge discounts and they do not really see the value of the medical offset, right? The IDN does because the IDN typically, most IDNs have that hospitalization cost as well. They can look at the big picture where the traditional PDP, you have a PBM that does not see the medical offset. All they care about is rebates. That is why the IDNs really are going to be a big part of our business moving forward. Okay, perfect. Back to CKD, obviously, we've talked about kind of the short-term plans and opportunity, but big picture, long-term, what's your view on CKD relative to heart failure? We look at it a little differently. We look at what contribution will come from nephrologists versus what will come from cardiologists or heart failure specialists because we do know that the nephrologist is treating heart failure as well. Heart and the kidney work together. A lot of cardiologists will allow the nephrologist to manage the fluid overload with a heart failure patient. We think 35%-40% when we're at peak will be from nephrology. Okay, and also to your point, in the past, I believe you said kind of the approval for CKD and nephrology presence lifts both boats. Is that fair? Correct. It will lift the heart failure boat as well. We've gone into nephrology offices, the big offices. We've made the reps, but it's confusing for a nephrologist if, does my patient have, because they kind of look at it as my patient has edema. Is it from their kidney or from their heart? You don't have a kidney indication. This allows us to go into that office. If your patient has edema, it doesn't matter if they have heart failure, kidney, both, you can write FUROSCIX now. Okay, we do want to make sure we spend some time on the auto-injector. SCP-111, you all have not been marketing it to KOLs, but when we inevitably bring it up, we are getting some high level of kind of enthusiasm, even for those that were maybe a little bit more hesitant to use your on-body device. Let's talk about first maybe some details of disclosures you've shown so far. What's the profile, administration time? What are the differences? We'll go from there. You know, again, I'll go back and say that the On-body Infusor is performing wonderfully in the field from the docs using it, the patients using it. The difference though with the auto- injector, there's a couple of big differences. One, obviously our COGS go down 70%, but also it's a two and a half second push. The patient just takes a cap off, puts it to their side, and it's done in two and a half seconds versus a five-hour wear. It's just going to be so much more convenient for patients. We do know, and we combat this every single day with our human factor studies, with everything we have, that doctors will look at some patients and say, "I don't think Mrs. Jones is a good candidate to wear something for five hours. I don't know if she can operate it. I don't know if she can wear it. Those are the patients without caregivers. There are some patients where the doctor says, "This patient's pretty active. They're not going to knock this off in the next five hours." We do think, yes, it flows to the bottom line on our COGS, but it really aids in penetration. I mean, we're hesitant to be talking about it in the field because we want them to use the current product, but it'll have a huge impact on the market when we launch it. Okay, and how do we reconcile maybe the five-hour infusion? Because we've been getting some questions to that two-second push. Yeah, it's just going to be the PK data. If you look at our PK data, now it's not the same. It's not the same graph, obviously, as the five-hour, but the threshold to approval and really the threshold to use by physicians is showing the PK equivalent to the IV. We did that with the five-hour infusion, and we're now doing it. You know, the skin acts as a buffer and slows down the infusion compared to an IV. It's not the same as an IV. It doesn't have the same Cmax. It doesn't get there as quick. So the PK study will show docs that this is similar to the IV from a bioavailability, but doesn't have the peaks that the IV has. Okay, wonderful. What are the remaining gating steps as it relates to potential for mid-2025 sNDA submission? We just need to finish. We've got almost two and a half years of stability on the drug product, which was the big challenge to get 80 milligrams in a 1 cc and keep it stable at pH neutrality. That was the biggest challenge with the auto- injector. Now it's finding the delivery device that can be, now this goes to shelf life. We're doing shelf life testing now at accelerated aging. We still feel good that we'll have this filed. That's all we have left to do is the shelf life in the auto- injector. We should have that data soon and then be ready to file mid-year. Okay, wonderful. Let's go near term again as it relates to FUROSCIX and what we're seeing in early 2025. Of course, want to be cognizant that we'll stick to the previous disclosures that you all have made. How is kind of that Medicare IRA redesign playing out in the short term? I think we've talked about the long-term benefits, but just help us understand the cadence of this year. Yeah, so you know the redesign, there was a couple, I guess for us, three major components of it. One was the biggest thing, which was the patient's cap going down from the $4,000 to the $2,000. That's going to be the biggest driver for us this year. Two, there was the increase in the rebate. Now again, if you're already paying a 50% rebate and they add 10% or 20% in the catastrophic, you're probably not getting anything for it because you've already contracted to get in preferred, to have low copays, to have access. We haven't had that. So we think the trade-off between, excuse me, the $2,000 out of pocket and the 10% to our GTN is so worth it. Just in our fill rates, every time we see patient copays go down, we see our fill rate go up, and we see the halo impact. The third component of the Medicare redesign that impacts us is the smoothing component where patients can sign up and have that $2,000 smoothed over the entire 12 months. That enrollment was supposed to start October 15th of last year. From what we can see, it really didn't start. We haven't seen, just in our book of business, the smoothing impact we thought we were going to see. We do see the $2,000 cap, but we don't see as much smoothing. It's happening, but it's happening, I think, slower than what we thought and clearly slower than what CMS thought. CMS thought 70% of the patients would enroll in smoothing. We might get there by the end of the year, but it's not on track. What we do see is when a script comes in, and even if it's a patient in PDP with a $2,000 copay, we tell them, our hub tells them, "Listen, you pay $2,000 now, you'll have no copays for the rest of the year on any medication." If a patient has a $2,000, they'll do that. Again, we think, again, for the year, it's really going to be a real tailwind. Q1, there's confusion out there, right? Patients don't understand it. Physicians don't really understand it. We just need to educate them more and more. Okay, got it. We'll see how IRA redesign plays out in terms of cadence of quarters. Again, to your point, IDNs should be a greater contributor over the course of the year. Now for 2025, and again, sounds like consensus is in kind of the low to mid-80s for millions. What are your views there? Very high level and maybe potential drivers for sales as we think about this year. We're two months in, so it's a little early. There's, you know, again, I think with the redesign, it's still a little, it's hard to forecast exactly how that all plays out. Again, we feel strongly in looking at what we're hearing and seeing that it's beneficial for us. We haven't given guidance yet. I think we want to see more of how the impact of the redesign goes, make sure we get the kidney approval. I think where we're sitting here today, we feel comfortable with those numbers. Okay, and potential drivers of growth? Yeah, there's a lot of them. We expanded the sales force in Q4. You know, it takes a quarter or two for the impact of that to happen. We really think that'll be a big growth driver for the entire year. Obviously, if we get CKD tomorrow, hopefully tomorrow, we think that'll be a driver. Probably not immediately, but clearly in the second half of the year. Again, I think for the balance of the year, especially in the second half of the year, the redesign, having patients with $0 copays is going to be huge for us. Again, it's going to take some time for them to get there, but we think it's a big driver for us. Those are three big drivers. Plus, we'll have Class IV for the whole year and continued focus on the IDNs. Okay, wonderful. What a great recap. Thanks so much for your time today and appreciate everyone listening in. Thank you. Thanks, everybody.