Growing fantastically. Just from that, John, for the people that aren't familiar, could you kind of give a little overview about yourself, scPharma, and FUROSCIX? Sure. Great, Naz. First off, thanks, thanks to you, and thanks for Max, and for having us. Yeah, so, John Tucker, I've been CEO here for about seven and a half years. I have a commercial background. Actually started in the industry as a sales rep with a bag. Worked my way up. This is my third CEO position, and really, when I came here, you know, a lot of my background was in health economics and outcomes research, and I saw with FUROSCIX kind of the cleanest value prop I've ever seen. So the story really behind scPharma is it's kind of in the name. Sc stands for subcutaneous. We look for drugs that are being delivered really in the hospital, in the inpatient setting, which, as you know, is the highest cost setting of care, also the setting of care with the worst outcomes for patients. And really looking for opportunities to drive that care to the lowest cost setting of care, where the outcomes are typically the best, and that's in the home. Our first product is FUROSCIX. It is 80 milligrams of 100% bioavailable furosemide delivered subcutaneously. We've developed, with our partner, West Pharmaceutical Services, a wearable patch pump that delivers this 80 milligrams of furosemide, 100% bioavailable, over five hours with a biphasic delivery, where we get 30 milligrams in the first hour, and then 12 and a half milligrams each of the next four hours, and this is really to mimic the IV. What we're trying to do, and what our you know, pivotal study did, was show that we had similar PK and PD to the IV, and, and we've done that, and that's also kind of our marketing study to say to doctors, "Hey, the oral starts to fail." Every patient's on oral Lasix, the oral will fail when a patient goes into gut edema. These are patients with heart failure, which have, you know, loads of fluid on them. When that happens, and they're taking their maintenance oral, because of the gut edema, the bioavailability of the oral actually goes down to about 10%. The doctors don't have a lot of choices. Before FUROSCIX, these patients ended up in the hospital. We're now giving them that same IV strength, but allowing them to use it at home. As you said, we launched just about 18 months ago, and we're growing revenues. You know, last quarter over quarter was 33%. So, a lot of work to do, but really excited with how well the product, how well it's accepted by physicians and especially by patients. Right. On that point, John, so FUROSCIX has been growing fantastically, in my opinion, but you're sort of still in, like, somewhat of a launch mode, all things considered. Yeah. So at this point, what do you think is more important, or what's, like, the bigger focus for you and scPharma? Is it more increasing physician awareness or more managing the reimbursement paradigm? I'm sure there's a combination there- Yeah ... of both. So where do you sort of see each of those right now? Yeah, it's both. You know, I think when you launch. This is really changing the parameters of how outpatient heart failure is cared for, right? These are really sick patients, and we're really changing how doctors care. So we've learned a lot about the doctors, the clinics, where there's opportunities, where there's not. We still need more physician awareness. We launched with only 40 reps. We wanted to kind of learn as we go. We're now up to 90 reps. We just did an expansion. Those reps hit the field on Friday of this week. So we're still trying to grow physician awareness using non-direct tactics, as well as direct with the sales force, but also reimbursement. You know, about yeah, you know, we talk about coverage. All patients are covered for FUROSCIX. It really comes down to co-pays, and as I know, we've talked a lot about it. Yeah. You know, in commercial and in Medicaid, and commercial's about 10% of our business, Medicaid's probably about 15%, we're in good shape. Our co-pays are all under $100. There is a subset of Medicare, probably about 30% of Medicare patients, where they have co-insurance, where that co-pay is still too high. With the co-insurance, if it's a script for five, they might have a $1,000 co-pay. We're not gonna, we're not gonna get that patient, right? So we've really been working to get those co-pays down. So that's a dual strategy. We need to continue to drive physician awareness, and adoption and advocacy, right? Mm-hmm. Docs have to believe it, but we have to work on keeping patients' co-pays down. Now, next year, and I'm not saying that, you know, we're giving up on this year, 'cause we're seeing co-pays come down this year through some of our efforts, but next year, with the Medicare realignment, patients are capped at $166 for all of their meds. These are heart failure patients, all of their meds for the month, so that big lever the PBMs have in Medicare kind of goes away. We're continuing. We've seen co-pays come down from Q2 to Q3 about 30% for our drug- Mm. and we hope to see it come down another 20% in Q4. Right. So I guess on that point, if all Medicare patients are supposed to have their prescriptions covered, are there thoughts on scaling back your existing co-pay programs next year, or do you wanna just maintain the program as, like, a backstop for patients? Yeah, so the commercial program will continue the way we're doing it. Medicaid will continue. Where the redesign is on Medicare, you know, there's not a lot you can do for Medicare patients from a patient assistance. We have an IPAP program, indigent patient program. I know some companies are looking at expanding those coming into next year. Our plan is to keep that, keep that the same. We're working with the major PBMs. We're having agreements with them about next year, and we think we're just in a really good position for the last quarter of this year, really rolling into next year. But we'll continue to offer the assistance programs we're offering now. ... I understood. John, you said you expanded your sales force from 90 reps, and now they're out in the field. Could you talk a little bit about what, if any, geographic expansion there was in terms of territory expansions that came with that, and- Sure ... sort of what the plan, strategic plan there, the rationale, and how's that going? Yeah, so we kind of did two things. Now, as we covered more wide area, we had 68 reps midway through Q3. We received the Class IV label expansion, so we took the sales force up to 90. So we are covering more geography, but we're also cutting the size of some territories to get more frequency. One thing we've noticed is, there's a lot of hand-holding here with heart failure, treating these patients different. So we really think reps need to be able to have a higher frequency, higher touch, especially on the heart failure clinics, where we really didn't have access because we didn't have Class IV. Now that we have access into those heart failure clinics, you know, there's a lot of hand-holding there, and there's a lot of sick patients there. So this enables us to give the attention to the big accounts, as well as cover more geography. Our goal, really, we want to continue to have more and more doctors start FUROSCIX, but what the real goal now is to get them using it more and more for more patient types, and I think we're seeing that with the expansion of the sales force. Right, and on that point of the heart failure clinics, just due to their own expertise, have you found the number of scripts... I'm sorry, number of doses per scripts increasing at those clinics, specifically between the Class II, and I guess now the Class IV patients? And also, have you found the adjudication process to be more efficient there, seeing how they're probably a little more used to this? So yeah, in Class IV, and we again got approval back in mid-August on Class IV, rolled it out really at the beginning of September, so it's still kind of new, five, six weeks in. Mm-hmm. But yeah, what we're seeing with these patients in Class IV, again, it's only about 10% of the patients, but they're the sickest patients, right? A lot of them are in palliative care or are coming into the clinic for two or three times a week for IV dose, just to get this fluid off. What we're seeing are doctors for these patients actually writing scripts as high as 12 units for a month. For Class IV. They're thinking... Yeah, they're thinking of it monthly, where, "Mrs. Jones needs this three days a week, so I'm gonna write her 12, and that takes care of her for the month." Now, they'll still check in with the patients, but so the script size in Class IV is higher than in Class II and Class III, and it's just because of the need of the patient. So there is some, I hate to call it prophylactic care, but when they know a patient just consistently gets into trouble. Mm ... they're prophylactically caring for them now by bringing them to the clinic three times a week. Now they can do the same thing, get that fluid off, and have it done in the patient's home. All right. Hey, John, for those patients with those high level scripts, what has been the reimbursement process like for that? Like, do they need to get multiple prior auths for that many scripts? And also, like, do PBMs and payers cover that many scripts? Like, how does that process work itself out? Yeah, they do. They have. We haven't seen a lot of pushback. We have a couple plans in a couple states, state Medicaid, where they've done caps of four or six. Mm. But that's really rare, and we get in and talk to them about how that really doesn't make sense. Okay. You need to treat till the fluid is off. So, we haven't seen pushback on those scripts. Now, keep in mind, the prior auth, you know, all of our patients are prior auth- Right ... and it's a look back to make sure that they've been on an oral diuretic. Boy, the history of these patients, these Class IV patients, there's just failure, failure- Mm ... hospitalization, failure, so we've gotten almost no pushback. In fact, they're being adjudicated quicker and easier than our Class II and our Class IIIs. And that copay for 12 is still whatever the copay is for three units, the same as it is for 12. So I think the doctors also, in their mind, think, "Boy, it's only gonna be one copay for Mrs. Jones. I might as well write 12," right? Got it. So on that point, they're getting adjudicated quicker, the Class II to III, I think for the most part during your launch, has been around, like, the 50%-55% range, give or take- Mm ... in terms of scripts, cleared. Is it still like that, or have you seen improvement there? In August, we saw it tick up. In September, and I haven't seen the final data, I think it's back in that 55 range. You know what? We have some unique. We've talked a lot about the dynamics with FUROSCIX. We talked about this prophylactic patient. We also have the doctor who writes it for a patient, checks the copay out. The copay's good, they're just gonna kind of put it on layaway, and when the patient needs it, they pull it down. So still about 20% of our scripts are treated that way. We do think next year, with the redesign, that our fill rate goes up to be in about the 70%, 70% range, and we hope it caps off at... You know, we're never gonna probably get to that 85, where some brands are, just because of the layaway, but we do think we can get into the mid-70s next year. Right, so overall, it sounds like the revenue per script, or I guess, like, revenue per patient should increase over time just because of the additional scripts. Mm. But do you also find, are you seeing that the patients actually get or acquiring all their scripts at once? Or do they get, like, a couple of scripts at the pharmacy and just come back, like, in month two to get more scripts? How does that- It- ... dynamic play itself out? Yeah, when the doc writes, let's say, a script that has six units in it, the pharmacy will ship them six units. Now, typically, the patient will use all of those units during an episode. There are some patients or some doctors we've heard that have, you know, told the patient, "Here, use four of these, call me." So maybe he wrote a script for six. The patient calls him after four and says, "Hey, I'm back down to my dry weight. I feel good. I'm not out of breath." And the doctor says, "Okay, put those two on the shelf. Next time you get in trouble, call me. We might have you do that again." So we're seeing that. One thing that we're really encouraged by is the number of repeat patients we're seeing. So all of our scripts that, and we've talked about this, all of our scripts are new RXs. We don't have TRXs, we don't have refills. They're all new RXs. But what we're seeing is a dramatic amount of the patients now had already been on the drug before. And this is only a look back to March, so in six months, we're seeing a high percentage of our patients who are repeat users, which is great. You know, it's obviously worked for the patient. They've stayed out of the hospital. But it's also the best kind of reminder to a doctor that, hey, a patient came back and said, "Boy, I put that patch pump on my stomach and I felt great." So we're really, we're really enthused by the number of repeat prescribers and really repeat users, patients, that we've seen in the last couple, couple months. Right. So I guess on that point, it sounds like these patients are arguably having as good of an experience as they could possibly have in this situation. Mm-hmm ... right, with FUROSCIX? Yeah. And you'd assume the physicians are prescribing it. What do you find has been the gaining factor or pushback from physicians that haven't prescribed FUROSCIX yet, or are concerned? What have their concerns been if, like, their colleagues or what, or what have you, have- Yeah ... had good prescribing experiences? So we don't get a lot of pushback. It's more, "Oh yeah, I forgot to do that." It's really changing the habit. You know, they've been kind of doubling the oral and sending to the hospital or doubling the oral and sending to the IV clinic. They've just been doing it their whole career, and it's just... It's just getting reminders, getting to use it on the first patient, and then we tend to get them to use it more and more. So there's not really a pushback. I mean, early on, we had questions: "Boy, if I use this, do I have to check labs, you know, check on their electrolytes? Yeah. They do, but no different than if they double the oral or do anything else. They're supposed to check labs. So, you know, that was initial kind of. I wouldn't say pushback, but questions, but it's really kind of the inertia of changing how care is given, especially when you have these heart failure clinics, which are fortresses, which are really kind of difficult to penetrate. A lot of different touch points to get them to change what they've always done, but again, we're making really good progress there. Right. I know you... Once again, this isn't prescribed as a first-line therapy. It is not prophylactic, but have you, like, seen docs or heard from docs trying to prescribe FUROSCIX as first line? Yeah, we- Like, the more standard ones. No, no doctor should ever write FUROSCIX before a patient's tried furosemide or torsemide. There's just no reason to do it. It's really, you know. And I always say this, it, FUROSCIX is an acute intervention in a chronic disease. These patients are gonna have heart failure till they die. They're gonna have episodes of worsening fluid, worsening heart failure. That's perfect. That's where FUROSCIX fits in. Write a script for four, five, six days, get that patient back to their normal weight, where the orals continue, will start working again, and then, yeah, probably you're gonna see that patient again. But really that's how the product was designed, to really fill that gap, to get the patients back on their maintenance therapy without having to be hospitalized or worse. Right. So it sounds like more or less, physicians and patients are having good experiences from FUROSCIX.. Can you quickly remind me, is FUROSCIX tier three right now on most plans? It depends. So, it depends on the plan. You know, typically, you're gonna see the generics in tier one. Right. So we're either tier three, we're not in per... You know, we've done a lot of work to keep us out of specialty tier, so we're not in specialty tier. So we'd typically be on tier three. Right. Is there any strategic thought on trying to become tier two? Is that, or is that just not somewhere you want to go with all the rebating, with the rebating paradigm? Yeah. So as we look at this year and especially next year, so what we're hearing on the redesign is a lot of these plans are just gonna have generics kind of preferred, and then maybe one brand, kind of, non-preferred formulary. There's no other brand, it's just us here. So paying 50 or 60% rebates to be in that non-preferred formulary, it doesn't make any sense for us, right? Now, we know we have mandatory rebates next year, 10% in the first period, and then 20% in the catastrophic. We think working with the plans just to make sure that FUROSCIX is available and that there's not gonna be any kind of strange utilization management- Yeah ... makes the most sense for us. So we talk a lot about our GTN this year. You know, we haven't had to pay those big, big rebates. We had a GTN of 8% in Q2 that was artificially low. We've said for the balance of this year, it's probably gonna be in the 15% range, quarter, each quarter. Next year, you know, with the mandatory rebates that come into play, we think we'll be in the 30%-35% by the end of the year, kind of with the guidance we've been given. And why that's so important is that's 30%-35%, but all of the patients will have access at $166 or less, and probably way less. So, we really think the strategy which we've taken this year of working with the plans, not paying massive rebates, understanding we're gonna have some patients with high co-pays next year, that goes away. So, we think we're in a really good position. Right. So just shifting gears to your pipeline a little bit, on, chronic kidney disease, have you gotten any feedback or any updates regarding your submission from the FDA? So, just one information request, IR we call them, information request. About two weeks after we filed the NDA or we submitted the NDA, they accepted the NDA, so they accepted that answer. We haven't had any other dialogue with them. You know, it's not atypical of the FDA to kind of back load the questions. So, you know, our PDUFA date's about five months away now. I would anticipate us hearing a lot in the next couple of months. But, you know, the IV is approved for chronic kidney disease. We're just asking to match the label of the IV, and we've proven we did that with our PK study. How many requests have you gotten for scripts for CKD? Like, do those get reimbursed, or do you see a lot of that? They won't get reimbursed. Now, I say that, if it's a patient that just has, you know, fluid overload from chronic kidney disease, that will not be covered. We've had scripts come in, it won't get covered. Now, a lot of these patients also have heart failure. Now, the nephrologist tends to take care of a patient with fluid overload who has CKD and heart failure, so those scripts will go through 'cause they're a heart failure patient. Right. One thing that we really look at is the kidney opportunity. We'll start calling on nephrologists. It'll also open up more of the heart failure opportunity, because a lot of times what a heart failure doctor does, if a patient has heart failure and chronic kidney disease and fluid overload, they let the nephrologist manage the fluid. That's what the nephrologist... all they do is manage fluid. By calling on nephrologists, we really open up even more of the heart failure opportunity. Got it. I mean, do you plan on increasing promotional efforts prior to the approval, or are you saying you're increasing promotional efforts now to nephrologists? So we've dialed in some nephrologists now- Uh-huh ... some of the bigger practices, just but on label, calling on them for heart failure patients. But it gives us a little toehold. You know, they've used the product, they understand how the product works. So it's a small effort in nephrology. I think once we... You know, March, early March, is our PDUFA date. We'll expand the sales force, you know, to take advantage of that, and wrap in more nephrology calls. We think at the end of the day that nephrology, if you just look at cardiology and nephrology, the nephrology's 40%-45% of the total market. Gotcha. And also on... staying on the pipeline, where do you stand with the auto-injector? Yep. Are you still on PDUFA target and for Q4? Yep, so we're still targeting getting it in late in the end of this quarter. That might slip. I think we've said we might slip into January. You know, we've got the human factors work just about done, the clinical trial, the drug stability, all of that, so we're still on track. Again, it might slip into Q1, but hopefully still at the end of this quarter. Got it. Hey, John, for the audience, could you kind of go over what scPharmaceuticals' current cash position and runway is? Yeah. So we, you know, haven't obviously announced Q3 yet. We announced Q2. Mm-hmm. We had about $36 million at the end of Q2. That doesn't include $75 million we received from a financing we did in August. So look at the $39 million we had, plus $75 million, would be our cash. Now, that doesn't. You know, that's, you know, there's gonna be obviously some burn we used in Q3. But we think with the $39 million we had, plus the $75 million we received in the financing we did in August, that takes us to profitability. I think if you look at some of the analyst forecasts, you know, that's gonna happen at the end of next year or early 2026, but we have plenty of cash to get there. Right. And on that point, you're on pace for profitability and you have a lot of cash. You obviously have a few pipeline initiatives, but they're all basically regulatory-wise being submitted this year, right? Yeah. Do you have any thoughts on potential business development and- Yeah ... like, any tuck-ins or anything next year? And so what kind of assets would you be looking at if you are also that? Yeah, so we are. I think for us, kind of the perfect asset, and you know, it's like a giant funnel. You put all these products in, and what comes in? It's something that we can put in the bag here, you know, either in cardiology or in renal or maybe one in cardiology and one in renal to match the call point. But we're also doing some internal work. But that would be the goal, to find something next year that we can put in the bag. You know, we've purposely waited 'cause we think the potential for FUROSCIX is so big and, you know, we're still learning so much, and now we're gonna go into kidney, that you know, you don't wanna take away from that effort. But we do think, you know, mid next year, to be able to put another product, be it, you know, something on the market. You know, there's interesting things there. Just gotta make sure it can still grow, that it's, you know, it's cashflow positive for us. But we can look at other things as well, maybe later stage. So we're gonna be picky. But we have cash. You know, we really think when we get to profitability, that kind of opens up another, you know, another place for us to play. But we hope to have something in the bag by mid next year. Got it. All right, John, looks like we're up on time. Are there any closing remarks you wanna make for the audience? No, I just wanna, just wanna thank you again. You know, we're really, really excited. Got it. I mean, drug's doing phenomenal out there. A big opportunity in kidney. We still have to execute here, but really excited about the future. All right, thank you. Thanks for joining us, John, for the audience. Thanks for your time, and if you wanna have a one-on-one with John or scPharma, or have any questions, feel free to reach out to your Maxim representative and we'll see if we can connect you. Once again, John, thanks for your time. It was always a- Thanks ... always a pleasure to have you. Thanks a lot, guys. Appreciate it. Okay. Bye bye.
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