Okay, thanks, and good afternoon, everybody. For our next presentation, we're excited to have scPharmaceuticals. It's one of these exciting little growth stories that, you know, one by one, it's popping up on people's radar screens as the company continues to make traction. So, it's something that we've been following for a little while. It's pretty exciting. Joining us from the company is the President and CEO, John Tucker, to my left, who's gonna give the presentation. This is mostly gonna be a fireside chat, but, you know, if we have some time, maybe we can field a question or two at the end. But, I have a lot of questions lined up, so John, we're gonna go sort of rapid fire Okay if that's, if that's okay. But since this is more of a general session, I do think it's probably worth us investing just a couple minutes up front, if you maybe wanna give us an overview of FUROSCIX, when you sorta got it approved, the current treatment landscape, you know, the value proposition the drug provides, and maybe just for anyone who's less familiar, and then we can just dive right into, dive right into the questions. Okay, that sounds great. Well, thanks, first of all, for hosting us, Glen. Yeah, scPharma, you know, the company started with a pretty simple idea. Our founder, cardiologist, saw that patients were in the hospital just receiving IV diuretics and were staying in there five or six days. Most of the patients that are admitted for heart failure, 75% of them, are due to simple congestion, just fluid overload. And was there a way to treat these patients, giving them IV efficacy, safety, and treat them at home, where patients will have better outcomes and where, you know, incur significant cost savings? And it kind of coincided with CMS saying: Hey, heart failure is now a category we consider for the Hospital Readmissions Reduction Program, that there's too many patients that are being hospitalized for heart failure and then discharged, and 30 days later, bouncing back into the hospital. Up to, at that time, 40% of patients would incur two hospitalizations within a 30-day period. So that was kind of the idea, and the company was formed on that idea of taking drugs that are delivered now, IV in the hospital that are proven safe and effective, and trying to find a way to formulate them so they could be delivered subcutaneous. Not easy. Furosemide, our lead product, which is FUROSCIX, which is subcutaneous furosemide, its pH is well over 9. It'd be like giving detergent under the skin if you did that. So we had to go about first trying to reformulate or come up with a formulation of furosemide that could be pH neutral, so it could be delivered subcutaneously and then could also stay in solution. And those were the challenges that, that we faced for years. We finally did find a way to do that, filed IP, went to the FDA and said: Hey, we have a 100% bioavailable furosemide that can be delivered subcutaneous. What do you think? They said, "Show us." And so we went and did a pivotal PK study, against the IV, showed, bioavailability similar to the IV. The FDA said, "Great, now tell us how you're gonna deliver it." So we worked. We're now working with West on an auto infuser, so the patient actually wears it. It's about the size of an iPhone, very simple. They drop the drug cartridge in, peel off the back, put it in their stomach, and they're home. They're home, getting 100% IV strength furosemide at home. So, we did studies that showed that, the cost of hospitalization, if a patient shows up at the ER with heart failure, they're gonna get admitted, and it's gonna cause the system, cost the system about $17,000. Our course of therapy is $4,500. So there's a really huge health economic story here, as well as a patient story. So before FUROSCIX, these patients would fail. They'd call the doctor, the doctor would say, "Okay, double your oral, come in and see me tomorrow." The patient couldn't walk up the stairs. They were out of breath. They couldn't put their shoes on, their feet were so swollen. They were in agony, and the doctor's doubling the oral, hoping it works, hoping the bioavailability increases. For most of these patients, it doesn't work. Five days later, they're in the hospital. Heart failure patient in the hospital. Heart failure patients have the worst outcomes in the hospital. Before COVID, it was nosocomial infections, dying from nosocomial infections. They're heart failure patients. They're sick. With COVID came, it was a disaster for these patients. These patients had the worst outcome, terrified to go to the hospital, dying in ambulances. We give them the ability to get the same effectiveness as IV. We'll get the fluid off. We can do it at home. These are heart failure patients. They're not, you know, running marathons, but they wanna be home. They wanna be with their family, their husband, their wife, their kids, their pets, their neighbors. We give them that ability. All right, let's, let's jump right into it. So you talked about the on-body infuser. Can you talk about the IP around that? And, you know, one of the things you talk about, right, is your 80-milligram auto-injector. What's the receptivity been to the on-body infuser, and why are you considering moving to an auto-injector? So, I'll talk about the IP first on the product that's on the market now, which was approved in October of 2022. We have IP on our drug formulation method to 2034, IP on We work with West on the auto infuser. Now, this isn't a simple device. It has software, battery, motor. Their IP is to 2035. But practical, it's a drug device combo with all those things, software, motor. If you look at any drug device combo, after loss of exclusivity, the market share 50%-60% long term. Dr. Reddy's can't pump out an auto, you know, an infuser. So we think the IP is well past 2035. We have developed the next generation. It took us three and a half years, but we actually have an auto-injector now. We're in our pivotal study. We're about halfway through it, which is 80 milligrams in 1 cc. So it's a two-step auto-injector. Patient takes the cap off, they just press it against their side. 2 seconds later, they get 80 milligrams of furosemide. That IP is out to 2040. So that product is in development now. We'll have PK results in August, and that's our pivotal study, and then we'll file that in later this year. Okay, excellent. And you touched on this in your prepared remarks, but you just mentioned sort of the WAC price, and I think, you know, obviously there's a pretty compelling value proposition. So you take this to the payers and talk about sort of that process and those conversations, the receptivity, sort of where you stand now in terms of your payer coverage. Yeah. So, you know, when we first launched, our biggest fear was that WAC on the drug is $898 a unit, that they'd say this is above the specialty threshold and put it in specialty tier, which is a% coinsurance. We've been really successful. That hasn't happened anywhere. It happened once in North Dakota. We removed that. So our coverage is 100%. Now, if you look at our book of business, 70% Medicare, 20 commercial, 10% Medicaid. I'll work back. With Medicaid, we have 100% coverage. We're on every formulary in the country. Copays, and we really focus on copays, range from $0 to $12. Commercial, we're preferred formulary at the biggest plan, United, there's a $60 copay. Everywhere else where we're not on formulary, we buy the copay down to $50. So with Medicaid and Medicare, which is Medicaid and commercial, which is about 30% of the business, we have copays all under $100. With Medicare, where the value prop, unfortunately, the PBMs get in the way a little bit of your value prop with Medicare. But, we have 100% coverage, and we've 100% out of specialty tier, which is the big accomplishment. About 70% of our patients have copays at $100 or less, which is the value prop we've or the brand promise is $100 or less. We've been successful downstream, away from the PBMs. Anyone that has the full cost of the patient, be it the doctor visit, the emergency room, the hospitalization, and the drug, we've had great success, like a Kaiser and IDN. Put us on formulary, it's in their protocols, they're using the drug every day. They see the value prop. So we still have work to do with 30% of the patients, making sure that their copays come down. Next year with the Medicare redesign, everyone's copay is $166 a month for all of their medications, their Entresto, their FUROSCIX, whatever else. So we really think the copay challenge, we're still tackling it this year, and we're continuing to prove Comes off the table next year? Comes off the table next year. Hmm. Interesting. All right, could we maybe just touch on the quarter, right? 'Cause we're in sort of launch process. You know, you showed great sort of sequential growth in that December quarter, and then I think people looked at the March quarter results, and the revenue was roughly flat at around $6 million, despite the fact that it looked like scripts were up. And so could you maybe talk through the first quarter and sort of what you saw and what the experience was? Yeah. So we're real happy with the fourth quarter. We had a, I mean the first, fourth quarter, yeah. We had a number. Or first quarter, sorry, number of challenges. First off, you know, just any first quarter, patients' out-of-pockets reset. So it, it's always a headwind for just about every pharmaceutical company. Same with ours. The second thing that happened to us was the Change Healthcare cyber attack, which everyone's like: "Well, why was that so impactful?" For us, every one of our prescriptions is a new prescription. We don't have TRXs. It's kinda like writing an antibiotic. You don't see any refills. It's the same thing with an acute 'cause we're an acute intervention in a chronic disease, so everything's a new Rx. There's no historic copay. So when Change went down, you know, a patient would get a prescription, we'd try to adjudicate it. We couldn't. Our hub couldn't adjudicate it because Change was down. So we'd go to the specialty pharmacy, and what's the copay? We have no idea. We don't know what it is. Patients are reluctant to take a drug where they don't know what their copay is. So when that hit February 21st, we were having a really strong quarter, fill rates were good, and it just ground to a halt for about three weeks until we had a workaround. So it impacted us. Probably 10%-15% of our business, our net sales went away. Our fill rate got hit. Prescriptions were still coming in, but we couldn't fill them. So it probably cost us $600,000-$700,000 in net revenue. And then we had something in Q4. I mentioned Kaiser. They put their big initial order in at the very end of the year in December. It was about $700,000 order that they didn't repeat it in Q1. So when you look at those three things, you know, we think it was a really strong quarter, well above where analysts- I'm sorry, what was the first thing? Was the patient out-of-pocket resetting? Patient out-of- and then Change Healthcare, and then just the effect of the Kaiser order. Yep. Now, we hope Kaiser orders this quarter. Yep. And so when we look at the fill rate this quarter, right, I mean, that was another thing that caught people's attention. The fill rate versus prescriptions written versus filled was, I think, at 46.5%, and you had been trending in the low 50s, 52%, 53%, and so are you attributing all that to Change Healthcare at this point? Yeah, the difference between Q4 and Q1, again, there was a little bit of the out-of-pocket reset for patients, but most of it was just due to Change Healthcare. Scripts were coming in, they couldn't get filled. We're seeing it normalize in Q1. Is the Change issue pretty much behind us at this point? It's done. It's done. It was contained in Q1. Okay. All right. I mean, when we look in 1Q, I mean, one of the metrics that sort of caught our eye was, you know, doses written was up 28% sequentially, right? So obviously, the revenue number's a little bit disappointing 'cause of the reasons we sort of talked about in the comparison, but it seems like the interest level's there. I mean, can you talk about the feedback you're getting from the physician community? It's been from the cardiologist community? It's been phenomenal from patients and physicians. We've had a number of patients call us and just say, "Boy, this has changed my life." I mean, you should hear some of the calls. "I was in the hospital 6 times last year. Now, I don't go to the hospital anymore." And the physician feedback is, "Boy, this works every time. It's 100% bioavailable furosemide. It's gonna work every time," and it has. And I think the most amazing thing is how quick it's working, that patients are feeling better within an hour of putting it on. These are patients that are severely fluid overload. They can't walk up the stairs, and now they're feeling better within an hour. So the feedback from physicians and from patients has been overwhelmingly positive. It exceeded our expectations. There's a lot of reasons doses don't get filled, right? But when you think about that fill rate, roughly either side of 50%, is that lower than you expected? I mean, and how do you start to close that gap between the scripts written versus filled? It is lower than we expected. There's a phenomenon we have that is another interesting thing with our drug, and I think this accelerated a little bit with the Change Healthcare. But we have doctors that have We had a doctor in New York write 40 scripts the other day. He didn't have 40 patients come in. He wrote them for patients who he knew were gonna get in trouble frequent flyers. So he'll do it, he'll write it, he'll get it cleared, PA cleared, understand the co-pays, and then as soon as the patient gets into trouble, boom! It's ready, ready to ship. So we're always gonna have that phenomenon. So, you know, if you look at our fill rate, which again, it's hovered in the 50s, in the low 50s, we still think we get that up to 80, 80% or so over time. And what are the mechanics that Change that? One, there are co-pays that are still too high. When we look at cancellation rates, which is about 20%, that's usually due to a high co-pay. We're working this year with the PBMs to actually bring those co-pays down, paying rebates. We talk about our GTN going up. Again, next year, we have mandatory rebates with Medicare, so we're doing our contracts to mimic those for next year. But again, those co-pays go down to $166 for all their drugs per month. So when the co-pays come down, the fill rate will go up. The other things we need to do. But we're still gonna have that dynamic, where doctors will put these on layaway. We're not discouraging that. Right. We want doctors writing our drug. So when the copays go down, that'll help. Also, we changed our hub in April, mainly to do better at reaching patients. You would think reaching patients is easy. Well, it's not that easy. These are older patients. They look at an 800 number on their phone, 'cause we have to call them before we deliver, and I don't recognize that. So then we started texting them. It was better, and then we started FedExing them just recently, so they're getting a letter. People open FedEx letters, so we're actually seeing that increase the fill rate as well. So it's a combination of better hub performance, copays coming down, and continue to educate doctors on, "Hey, if this patient has a PA, can you just please put the notes that they were on furosemide oral and failed?" So get that, get that better as well, and those will all increase the fill rate. So we think it'll end up around 80%. Okay, awesome. Then, and can you talk about that fill rate throughout this year? I mean, obviously, you're not gonna get to 80% this year. I don't think that's what you're saying. I don't think we will this year. But will we see sequential improvement- It'll trend up. but the bigger improvement comes next year. Yeah with a reimbursement change on Medicare? Exactly. It'll trend up this year and then, and then pop next year earlier. You know, when we were talking, you know, pre-approval, right, I would think the hope was, you know, 4 doses per script, and that number's come in 50% higher, at about 6 doses per script. You know, what's any pushback on the managed care side as a result of that, given the extra cost? We haven't seen that yet. We do have some plans that put a 4-unit Limit? You know, limit, limit on it. A lot of state Medicaids, we see that more in Medicaid and some in commercial. United, so we're on Preferred with United, that's a 4 limit. Now, it's not 4 a month, it's 4 a script. They wanna get that other copay. We have seen them higher than we thought. I think we had originally guided to 4 - 4.5. It's been closer to 6. What's happening is really the patient mix. We're seeing a lot more pre-admission patients, where doctors, these patients just starting to get in trouble, are giving them a full course of therapy to make sure that they're drying out. We think that evolves, and they start using it post-discharge. Now, those patients are more at risk of a bounce back, so the doctors wanted to make sure that it's working. So we've anticipated seeing more pre-admission use. We'll start seeing more post-discharge use, and that will force the script counts down. What about the gross and net on the product, right? I think you sort of gave guidance. You think ultimately, you get to 30%-35%. I mean, talk about how your commercial efforts this year and Medicare next year will influence that gross to net rate. So, we're at 19%. I think last year, we were 18%. This year, we're at 19%. It'll trend up in the second half of the year as we get more and more contracts, and our contracts are really gonna be based on mandatory payments next year that we're not paying this year to mimic what we're doing next year. So we do think the GTNs, because of those contracts, will go- it goes up. It'll probably exit the year at around 30%-35%. Okay. Be around the same next year as well. Same next year. I mean, not to put you on the spot, anything you can talk about with respect to 2Q? I mean, the thing is sort of continuing to recover post the Change issue and- Yeah, so we've put Change behind us. We do our own hub transition again to increase the patient and physician experience and to increase fill rates. And, you know, that's always a little disruptive in April, but we've seen the impact on that in May. We've had a real strong start to the quarter and hope to end it as strong. It's, you know, both demand and fill rate bouncing back to above where it was before Change. You know, the, obviously, the value proposition is compelling, right? And so that's liable to potentially draw incremental competition. Can you talk about the competitive landscape here, any barriers to entry around other drug device sort of combinations? So, you're exactly right. I think people have seen what we're doing and saying, "Boy, that, that, that seems to make sense." Again, it's gonna be really hard even when our IP runs out in 2035 for anyone to do an AB-rated generic. That won't happen, can't happen until 2035. Even then, I think it'll be difficult. We know there's other people working on, you know, drug device combos to try to come into the market. No one's approved. We just think when we look at our auto-injector, the IP around that is incredibly strong on the formulation. We think that that protects us well into 2040 with no competition on a auto-injector-. with furosemide. Hmm. So you expect some competition, but maybe the competitive advantage here is ultimately gonna be the auto-injector? I think so. I think ultimately, yes. Yeah. I appreciate that you're not giving any guidance at this point. I mean, you're in your first real year of the launch. I mean, any idea, like, do you think that's next year's business, you'll have a better sense? Yeah. I mean, I'm not pressing you for guidance or anyway. Yeah. Yeah, Yeah, you know, we're hoping we can give some guidance in August, when we do Q2 for the balance of the year. Oh. That's our hope. You know, it's still. You know, we're recovering from that Change, and- I figured you'd wanna wait till you have some more contracts under your belt Yeah, I think- and you have a sense for kind of how things are shaking up. We'll see where we are in August. All right. Can we talk about the balance sheet? I think you had $58 million in cash at the end of the quarter. I mean, how do you think about that? And I know, you know, there's obviously some. We get the questions around the cash runway and, and- But there's also some other, you know, funding or financing agreements that you have in place, you know, with Oaktree, and I think you have the ability to grab, you know, another two tranches of $25 million. But talk about sort of the cash and financing situation, and, you know, we'll, we'll shift the conversation into sort of your operating expenses in a second, or maybe we can wrap all that together. So how we should think about the runway you have based on where the balance sheet sits today. So we had about a year of cash, $58 million, if you, if you look at the current burn. Now, our burn is now going down quarter-over-quarter as revenue ramps. Well, our R&D expense will go down through the balance of the year. We'll finish our pivotal study. We'll have an incremental increase in SG&A because we're adding sales reps in August for our Class 4 expansion. But if you look at kind of where our loss is, it's peaked. It peaked last quarter. It'll go down. It'll go down every, every quarter moving forward. We've said you know, typically, a drug like this would be profitable, you know, somewhere in 2025. I think we still feel that way, again, if nothing, if we're not doing anything else. So we think we're you know, with our Oaktree tranches, where we have $25 million we can take down mid this year, there's a revenue milestone, but we're really comfortable we'll hit that, and another $25 million we can take down by the end of the year, that we have cash to get there. You know, and that's how we're looking at it. Now You have cash to get to the profitability in 2025, you're suggesting? We with those two tranches based on one of our operating plans, yes, we do. And you said the loss has peaked, and that's because the operating expenses should hold somewhat constant. Are staying somewhat flat. Yeah, correct. Now, our salesforce expansion will add about $1.5 million a quarter to the OpEx, but that'll be offset by the revenue. So we think the OpEx stays pretty constant. The R&D goes down a little bit in the second half of the year. The SG&A goes down—I mean, goes up—just about $1.5 million a quarter. But we think with the OpEx staying the same and revenues continuing to grow, you're gonna see our net loss go down quickly. Not that you don't have enough on your plate and enough opportunity, but now you're in line for the Class 4 indication. I don't know if you wanna just quickly touch on how incremental that can be at this point. Yeah. So we're indicated now for New York Heart Association Class 2 and Class 3 heart failure. We filed back in October to expand that to Class 4. These are the sickest patients. Now, half of them are too sick. They're waiting for transplants or LVADs or whatever. But it's the other half that is a high unmet need. These are palliative care patients. These are patients that are hospitalized six times a year. We know where they're seen. They're seen in heart failure clinics. We know that there's some doctors that. "See, if it doesn't work for my sickest patients, why am I adopting this product?" So we really think it opens up the opportunity not just for the Class 4 patients, but really doctors who treat 3, 2, 2 and 3 as well. So our PDUFA date's in August. We feel incredibly comfortable we're gonna get this. We've had dialogue with the FDA. We've shown in some of our other clinical studies, Class 4 patients in it, who've done just as well as 2 and 3. So we're real excited. We're expanding the sales force to 90 in anticipation of that, putting a marketing campaign and really get out there. What about the indication expansion for treatment of edema in the chronic kidney patients? So that's gonna be huge for us. At the end of the day, we think we'll have more scripts written by nephrologists for FUROSCIX auto-injector or the current infuser than any of the cardiologists. There's about 700,000-900,000 patients that have CKD with edema, that do not have heart failure, that are not in dialysis, that are on diuretics and are failing on diuretics every year. The value prop's the same. The need is high. Nephrologists write more diuretics than even cardiologists. We'll get that indication in March, we've already filed for that, and launch with 125-130 reps in March for chronic kidney and have chronic kidney and heart failure. All right, I'm showing triple zeros on the clock. So the question to you is, I mean, any last word that you wanna leave the investors with? I mean, anything we didn't touch on that you just quickly wanna mention, but I'll give you the last word. Great, thanks. Again, thanks a lot, Glen. No, we're just really enthused with how the product's working. I mean, if you look at a launch, the most important thing, are you helping patients? And we're helping patients every day. We couldn't be more pleased with how the product's performing in the market, the feedback from physicians, nurses, and patients. We look forward to the expansion opportunities to get the sales force bigger. We're only covering about 33% of the opportunity in the deciles. We need to get more of that to really grow the ramp. With Class 4, we'll be able do that, and then with kidney. So we think with all the catalysts in front of us, from label expansion to pivotal readout in August, and then kidney next year in the first quarter, it's really gonna be an exciting year for us. All right, John, thank you very much.