All right, perfect. Why don't we get started? For our next presentation, we're excited to have scPharmaceuticals here with us. For those of you who don't know me, I'm Glen Santangelo. I'm, I cover the specialty pharmaceutical sector at Jefferies. I cover SCPH. With us joining from the company is John Tucker, who's the president and CEO of the company. And I think the way we're gonna do this presentation is John had, you know, eight, 10 minutes worth of slides that he wanted to run through just to sort of introduce the company, maybe talk about the most recent quarter, and then we're gonna jump right into Q&A. And I have a live microphone, as you can see, so it's a small enough crowd, so if anybody has any questions, we can pass you the microphone. Please feel free, because I'm sure John would be interested in taking your questions if there are any. With that, John, let me turn it over to you to get started. Thanks, Glen. I really, really appreciate the opportunity. So scPharmaceuticals, for you that don't know the story, we really... The name says a lot. SC, subcutaneous. We're taking treatments that are now given or were given in the hospital, doing formulation work on the drug, developing the best way to deliver these through a drug device combo or whatever, and really taking the care from the highest cost setting of, of the highest cost setting, which is the hospital, and driving it into the lowest cost setting, which is the patient's home. So typical forward-looking statements. Again, the company highlights, we have our first product, FUROSCIX, approved for the treatment of congestion due to fluid overload in patients with, with chronic heart failure. Very clear value proposition and reimbursement story. We launched in late February of last year, about $7.5 million of revenue in the first two quarters. Great IP out to 2034, and real strong financial position with about $90 million in the bank as of the end of September. So heart failure, big problem, about 6.5 million patients in the U.S., about 16 million in the G7. We really focus on how many times a year these patients decompensate, or they're on oral furosemide, oral Lasix, and they actually have congestion, they have building fluid, and the oral stops working. The bioavailability of the oral can go all the way down to 10%. So this really is a bioavailability story. The patient's taking on fluid, they're on orals, the orals stop working, they need 100% bioavailable furosemide. The only way for them to really get it before FUROSCIX was to go into the hospital and get four or five days of IV therapy. So this happens about four million x a year. If you, if you, if you take that out, it's about a $7 billion market opportunity. This is a big problem. So you got a big opportunity, but it's a big problem. This is the number one cause of hospitalization for patients over the age of 65, and it represents about a third of all Medicare heart, Medicare Part A and Part B spending, is taking care of these patients. So really, what we're trying to do is treat these patients at home, and save the system money by reducing admissions and costly readmissions. This shows it, heart failure, and this is the U.S. data, represents that, about 10% of Medicare patients have heart failure, but it's about 41% of our all Medicare admissions and about 50% of all readmissions to the hospital. So 10% of the patients in the United States in Medicare, have heart failure, but heart failure represents about 50% of of all hospitalizations, which really drives the cost. So where are the chances for FUROSCIX to work? Really, there's two opportunities. When this patient first starts taking on fluid, they've been on oral Lasix, and it stops working for whatever reason. It could be progression of disease, it could be dietary, you know, non-compliance, exercise non-compliance. They start taking on fluid. There's the opportunity for FUROSCIX. As soon as that oral stops working, instead of that, that, that doctor trying everything, doubling the oral, adding metolazone, bringing them in for IV, right there, as soon as you can, put them on FUROSCIX. Keep that patient from getting so bad that they need to be hospitalized. Some patients are gonna be hospitalized. They're gonna be in there for four or five days on average. The opportunity for FUROSCIX is when they come out, 50% of them- Hey, John, what's the timeline look like in the decompensation from when they detect the oral diuretics may not be working? It, it's a little, every patient's a little different, but it's typically two-three weeks, they have an opportunity to intervene. Again, what they'll do now or before FUROSCIX is they double the oral and kind of wait and see if that, hope that works, then maybe add a different oral, then maybe add a non-loop, then maybe bring them in for IV. All of those things, just trying to keep them from being hospitalized. Now, we showed this in our at-home pilot study, you could put them on FUROSCIX. You don't have to do all of those things and get patients feeling better faster, instead of waiting all that time, and then half of them end up in the hospital anyways. But the other opportunity... And so we're seeing most of our use right now in the prevention window, but the other opportunity, it's after they've been in the hospital for four or five days. They're discharged, half of them are still residually congested. They still have some level of congestion. They're the ones most in danger of bouncing back into the hospital. So the patient's been in the hospital five days, the Medicare's already paid $12,000, and half of these patients are at risk of bouncing back. That's why Medicare actually put a readmission reduction penalty in place, to keep these hospitals from getting them out so early that they're in danger of bouncing back. So we really look at this post-discharge patient period as a real good opportunity for the drug. In fact, we've had a lot of uses when the patient is ready to get out, the doc says: "Oh, I'm gonna finish his diuresis at home," and they're actually ordering FUROSCIX right at, right at discharge. So what is FUROSCIX quickly? It's a drug device combo regulated as a drug. It's 10 mL, which equals 80 milligrams of furosemide that we have in a prefilled cartridge, and that's our proprietary formulation. We have IP on that to 2034. Delivered in an on-body patch pump about the size, smaller than an iPhone, that we've worked with West Pharmaceutical Services. They have the same platform for SKYRIZI and Repatha. And this patient just puts it on their stomach, presses the button, and that replaces a day in the hospital. Fully disposable, they'll use four or five of them, and that will avoid a hospitalization. Our pivotal study, as well as kind of our marketing study, was a PK showing the same bioavailability as the IV. That's what we're trying to do. We're saying you can get IV strength furosemide at home instead of in the hospital. So the FDA agreed this is our pivotal study, this is the basis of approval, but it's also, also the basis of why a physician would use this. Oral's not working, I need 100% bioavailable furosemide, and we show that we give them, we give them that with this PK study. We also did a health economic study called FREEDOM, which showed patients showing up at the ER. They've tried everything. Everything failed. They're at the ER. When they show up at the ER, 90%-95% of them will be admitted. We turned those patients around with FUROSCIX and compared it to a historical cohort of patients that were hospitalized, and end up saving the system about $17,000 a patient with a p-value of less than 0.0001. So this is the basis of what we're working with the payers on. So talk real quickly before I finish, looking at the market, about 6.5 million patients, they decompensate about four million x. About half the times, orals work, and they can stay out of the hospital. But about 2 million times a year, it doesn't. Orals just not gonna work. What are they doing with these patients? They're admitting them. They're bringing them in four or five days in a row for IV. They're adding metolazone. They're doing everything they possibly can, and these patients are still being hospitalized. We're charging about $822 a unit. We look at four days of therapy, so it gives you a market opportunity of about $6.9 billion. It's a really interesting category where your stakeholders are all aligned. Your payers, they don't wanna pay for a hospitalization. It's $12,000-$20,000 to hospitalize one of these patients. They know these patients bounce back. Half of them are discharged with residual congestion, and about half of those, so a quarter of all the population, bounce back, and back in the hospital. So the payer's motivated. The hospital's motivated. They like full beds. Every hospital likes full beds. They don't like full beds of heart failure patients. They overstay their DRG. The DRG pays 3.9 days. They're staying over five days, and then they're bouncing back, a quarter of them, back into the hospital, and the hospital is getting penalized from CMS for these readmissions. The physician doesn't, you know, want the patient to be hospitalized. These patients are at the highest risk of patients going around hospital for nosocomial infections, COVID, you name it. They're bad outcomes. It's a failure of diuretic management if this patient has to be hospitalized. And then the patient. Now, these patients, they're heart failure patients, they're probably not out running marathons, but they, they wanna be home. They wanna be with their, their wife or husband, their kids, their neighbors, their pets. So everyone is motivated to keep these patients from getting so severe that they need to be hospitalized or rehospitalized, and that's really where FUROSCIX shows up. So how are we doing? So last quarter, we announced Wednesday after the close last week, almost $4 million, an increase of 138% from Q2, which is really our launch quarter. About 1,600 total prescriptions written, up about 36% from Q2. When we looked at doses filled, up about 60% from our first quarter on the market. I think one of the biggest metrics to look at was the increase in new prescribers, which increased about 77% from the first quarter of launch, which was Q2, until Q3. We've really been focused on in-services, kind of like a hospital in-service. We really think the key metric here for how the product to do long term is to have successful use in the marketplace. And we've spent a lot of time training nurses and doctors on how to educate patients on how best to use it. And the feedback we're receiving from the field has been incredible on how fast it's working. We've already had 400 patients that have come back for a second course of therapy. They had four or five units, did great, came back three months later. Typical what happens, it's an acute intervention into a chronic condition, and they've actually come back and had therapy a second time. So the product's doing phenomenal in the field. Our GTN is only 21% discount, which sounds great. It is great. That will change as more and more payers come on board, as we contract with more Medicare payers. We've anticipated that's gonna go up to 35% or 40%. Our inventory levels stayed the same. To look at it a little bit more, here's the growth. Again, Q1 was only about a month in March, Q2 and then the growth to Q3, both in Rx as filled and doses filled. We talked about it on the call on Wednesday night. October and November have been our best two months to date. So, you know, I know what the street estimate for the quarter is $5.3 million. We feel really confident about that. Again, it's funny, I think, you know, we spend so much time opening new prescribers, that now what the focus has really been in the last 45 days has been turning an office from, "Hey, I've tried it," and then we come back, "Oh yeah, I forgot that patient did really well," to now having physicians and nurse practitioners really adopt it as part of their practice. And that's really what we've been seeing in the last couple of months as we're really off to a strong start in November. So that's really the story going to- Okay, great update. So why don't we just jump right into the Q&A? Again, I have a microphone if anybody wants to ask a question from the audience. You know, you said almost 1,600 scripts this quarter that you reported last Wednesday night. That was up 36% sequentially, as you said. In your prepared remarks, you said some of the physicians are using it prophylactically, and some of the hospitals are prescribing it for patients that are leaving the hospital. Could you talk about that split in terms of what you're seeing- Yeah, so- - in practice? So what we're seeing is kind of... We'll talk about doctor's office first, then talk a little bit more about the hospital. But what doctors are doing is some doctors, when we call on them, they think of patients they know are going to get into trouble. And that's especially true as you're in Q4, where the holidays in the States, Thanksgiving, and these patients don't want to be hospitalized. These patients, from a dietary standpoint, this is the heart failure quarter. So we've already seen in this quarter, doctors saying, "I know Mrs. Smith's gonna be in trouble, so I'm gonna write FUROSCIX, I'm gonna have it cleared by the payer, I'm gonna communicate everything, and then as soon as she gets in trouble, boom, I'm gonna ship it to her house, or we're having it shipped to her house right now, even before she runs into trouble." So she has it on the shelf, so when Thanksgiving comes, and she has too much turkey or whatever, that FUROSCIX is sitting, sitting right there. So doctors are doing that. They were doing it in Q2. They did it more in Q3, and we're seeing more of it in Q4 as they get more and more comfortable. But, from a compliance perspective, does that patient need to be educated on how to use the product or? Before they prescribe it, they'll bring the patient in. They'll show the patient how to use it, then they'll prescribe it, and it'll be home for the patient. But we're also providing training materials for the patients, an IFU, information in the office, information on the website, one-800 number for the patient to call. But we really, the docs still need to touch the patients, even if they're gonna prescribe it kind of on a layaway. The other thing we're seeing is, as patients are getting ready to leave the hospital, so they've been in three or four days, and the patient wants to go home, the hospital wants them to go home, the doctors are actually prescribing it for that patient to go home. So the drug's actually there for them to finish their diuresis. So they realize that the patient has been in here three or four days, is pretty much on the way to being dry, but needs a little bit more, and they're writing FUROSCIX, and it's showing up at the patient's house when the patient gets home. So it's a nice- John, you didn't. You touched on it a little bit, but of the scripts written this quarter, I think, you know, 877 were filled to roughly 56%, and that number was up from where it was in 2Q, and I get it, that, that was sort of the launch quarter. You said, 442 that had been payer cleared and pending. Could you talk about some of those trends between when the script is written versus what's getting shipped, versus what's still payer pending, and what some of those roadblocks have looked like, and what the company's doing to improve on those metrics? So you mentioned about 56% of them are- I think it was... Yeah, 56. fills, filled, 56. So, what's the balance? What, what's going on with those other ones? So there's a number of buckets those sit in. One of them are scripts that come in at the end of the quarter, like the last day of the quarter. There's really no way to fill those in the quarter. So there's always, you know, a slug of scripts that are gonna get filled the next quarter. There are some that are on what I call layaway, where they've been written, they've been processed, and they're just sitting there waiting for the patient to get into trouble, and they get shipped. There are some that are just pending the payers. Commercial scripts can take three or four days to get cleared, and then we have about 20% of all scripts that will get cancelled. Typically, why they're cancelled is the patient has been hospitalized waiting for the ship to script-- I mean, the script to ship. The patient has deceased waiting for a number of reasons, not just congestion. And then there are patients that cancel due to high co-pays. The average co-pay for a patient that cancels is about $1,400. So that's what we're really focused on with payers. So the commercial, which is about 10% of our business, co-pays, we can buy the co-pay down. We're already on formulary preferred with United, the largest commercial plan, so those patients all have co-pays under $60. And then we can buy the co-pay down on commercial. So commercial's in good shape. Medicaid, we've been it's been great with Medicaid. It's, again, about 10%-15% of our business. We've had to pay no supplemental rebating, so we're even on Medi-Cal. You go to Medi-Cal, $0 co-pay on Medi-Cal, and we're paying the 23.1% federal mandate. So Medicaid's in great shape. Medicare, which is about 70% of our patients, about 60% of our patients right now have a fixed-year co-pay of $100 or less. That's the key metric for us, is to have co-pays at $100 or less. Patients do not balk. To stay out of the hospital, they'll pay the $100. So what our goal is, is to move more of those patients, that 60%-40%, into a fixed-year co-pay. And we're negotiating with the plans. I mean, when we first came out, they wanted massive, massive rebates to do this... and our value prop shows that we're saving your downstream, especially with PBMs, your downstream clients money. So we've been in the middle of those negotiations. We're really close. We just announced the largest integrated health network. We didn't use the name, but I think we all know what the, what the name is. That's that have made this available to all their patients at a co-pay ranging from $16-$75. And that integrated networks are our, our best, our best friends. They have the full cost of care for that patient. They contract with Medicare, that patient's hospitalized, they pay for it, they pay for the drug, the hospitalization. So the goal is to get that fill rate up to... You know, you'll never get any drug to 100%. We think in time we can get that to 85% or 90%. Hmm. And could you maybe just elaborate a little bit on that FREEDOM Study? Because I think that's a very important point you were just sort of touching on, right? I mean, the real cost comparison should be versus the DRG, which I think you said was a $17,000 stay, right? So even if somebody uses, you know, five doses per script, right, at- Yeah ... you know, 800 and change, right? I mean, you could do the math, but I'll, I'll let you just sort of elaborate on the cost savings differential. When someone says: "What's your comparison for cost?" It's always the cost of the hospitalization, which can range. Again, the DRG pays $12,000, but there's all kinds of costs just on top of that, which is the ER, which is the doctor visit. So again, we showed in FREEDOM about a $17,000 differential, but before the cost of the drug. So even if you put the cost of the drug in, you're still saving the system $13,000-$14,000. SOFR someone like a Kaiser integrated delivery network, who has that full cost, it's a no-brainer. For a PBM, like an Express Scripts, it's a little harder argument 'cause they don't see the cost savings. Their downstream customers do, but the PBM doesn't. So that's where the negotiations are now. But clearly, FREEDOM shows the ability of an integrated network to save money. We just need to pull that downstream of the PBMs. Just knowing you, you're a very patient person, so could you maybe comment on those negotiations, how they're going, how they've been progressing? I get it, it's early days, you know, you're 6-7 months post-launch, but how have the negotiations progressed? So again, we just finished with the top integrated network. I mentioned their name earlier. We're not supposed to mention their name in the press releases. So that was a big win for us. And you know, that happened in late October, so we hope to see results from that moving forward. And then you look at... You know, you really have three or four more customers. You have Express Scripts, Caremark, Humana, and Optum. I would say with two of those four, we're very close. Again, we're not gonna offer 75% rebates. It's a non-competitive category with a clear value proposition. We're just not gonna do that. But, you know, they rejected our first offer, we rejected their counters, and now we're meeting in the middle. But every day, scripts are getting filled, Medicare Part D scripts, Caremark, Express Scripts, Optum receive no rebates from us at all. So our GTN was 21%- Hmm ... 'cause we're not paying rebates in Medicare Part D. That will go up, and it's a good thing it's gonna go up, right? We've said 35%-40%, and that'll just show that we've actually, you know, signed contracts with those plans or those PBMs. And it's gonna provide greater access to patients, lowering their co-pay, quicker in their adjudication time. But we're very close with a couple of the big four. John, could you maybe spend a minute talking about the competitive landscape? You know, maybe speak to the barriers to entry around other drug device sort of products. I mean, I know you touched on the IP portfolio around your specific product, but how should we think about, you know, the barriers to entry and the competitive landscape here? Yeah. Drug device combos are tough. We had two. We know better than anyone, we had two CRLs. And it's okay that it's tough. It's heart failure. These patients are really vulnerable patients. And so the FDA is really cautious about any product for heart failure. So, you know, we have IP on our drug to 2034 on the West device to 2035. If you've looked at other drug device combos, if you're talking about generic entry, EpiPen, Advair Diskus, you know, still enjoy 60% market share well after patent expiry. So we think the competitive barriers, you know, if you look at any, you know, generic entry, are pretty high, just because of the nature of a drug device combination. 'Cause you have to really get approval. It's really getting approval of a new drug, an NDA, and a new device, because you have to have CDRH involvement there. So we think those barriers are high. I got two minutes left, and I do have two questions that I want to hit. You know, you talked about the balance sheet. You have $90 million in cash, but I... There's more funding available to you upon certain revenue milestones with Oaktree. I think you also mentioned 12 sales territories, 66 reps. I mean, when you think about operating expenses in 2024, should they grow materially from the run rate in the back half of this year? Do you feel like there's a lot of investments that's needed to sort of continue here? We had $90 million in the bank at the end of the quarter. We do have 2 more tranches available with Oaktree. That debt's pretty inexpensive. When you look at it now, it's pretty inexpensive. It's a cap SOFR a 3% +8- I mean, I'm getting 5% on that money in the bank right now, so it's basically 6% money. And that includes the terms of the other tranches we can draw down if we so desire. There's revenue milestones we need to achieve to pull those down, and we think those are very attainable, and we'll get them next year. So we'll have access to that capital next year if we decide to pull it down. If you look at what our, you know, OpEx looks forward, we are investing in some pipeline things. You know, we're really excited about our auto-injector, which we've been working on for about three years now. We'll do a PK study starting next quarter, have those results in the middle of the year, and then file an NDA for that, hopefully by the end of 2024. It, 2024. It, you know, it's give another option to patients, but it really takes our COGS down dramatically. We're talking over 60%, which gives us a lot of flexibility if we still need to do more work with plans or if we just wanna, you know, look at it from a P&L standpoint. Also has a lot of advantages for the, for the environment. But it's a pretty inexpensive project. I mean, from start to finish, well, for in 2024, we'll probably spend $1.5 million to get that, or maybe $1 million-$1.7 million, to get that to an NDA. The sales force, you know, we're, we're- we put 12 more reps on. If you look at what we- OpEx was last quarter, it probably looks a little bit pretty similar to that moving forward. You maybe wanna add another 10-20 reps next year. A rep cost us about $300,000. So if we add 20, say we did it mid-year, it's another $3 million total. So I think it's gonna look very similar to the end of end of- All right. Just on your earlier comments regarding October and November, you seem to sound pretty confident that things are sequentially on a similar trajectory to what we saw in 3Q, which is nice, which maybe makes that $5.3 million on consensus seem somewhat reasonable. We feel really good about that. Okay. And so let's just say you're sorta exiting the year at, you know, $5-$6 million quarterly run rate, right? That would be $20-$25 million, let's call it rough numbers. You know, I'm just trying to put that in perspective to next year's consensus numbers in the high $30s. I know you don't give guidance, you don't wanna give guidance, but it just doesn't seem like there's anything heroic expected in next year, just sort of given the launch trajectory you're on. And I don't know if there's anything you can say that would help us think about that or put that into some type of perspective without giving specific guidance. Yeah. So, if you look at the consensus for this quarter, as you said, $5 million, it doesn't take much growth from that number to get to the $38-$39 million- Yeah ... consensus next year. So we're really comfortable with this quarter, with this year. And sitting here today, you know, we're not giving guidance per se, but that $38-$39 million next year, I'm not wor- It doesn't- ... I'm... I'm not worried about it. No. Okay. Well, I'm always worried about it, but we feel really comfortable we'll be able to make that. Okay, I, I'm already over. I wanna give you the last- Okay ... 30 seconds if there's anything you wanna leave the audience with that, that we didn't talk about. I think the big thing is, how well the product's working in the marketplace and having 400 patients already come back for a second course of therapy, I think says it all. And we're just really excited about this quarter and especially moving into next year. And then just wanna thank you a lot for the opportunity. I said earlier, John's a patient guy. Don't let his calming demeanor fool you. He's very impatient. So I'm sure we'll see great things- Thanks ... out of the company. Appreciate it. Thank you, John. Thank you. Appreciate it.