SC Pharmaceuticals at TD Cowen Conference: Strategic Growth in Healthcare

On Wednesday, 05 March 2025, SC Pharmaceuticals (NASDAQ: SCPH) presented at the TD Cowen 45th Annual Healthcare Conference. CEO John Tucker highlighted the company’s strategic initiatives, focusing on the expansion of their flagship product, Frosix, into new patient groups and potential market opportunities. While positive feedback from patients and physicians underscores Frosix’s efficacy, the company also faces challenges in navigating Medicare redesigns and preparing for potential regulatory approvals.

Key Takeaways

• SC Pharma is targeting an expansion of Frosix into Class IV heart failure and chronic kidney disease (CKD) patients.
• Positive patient and physician feedback supports Frosix’s rapid relief capabilities.
• The Medicare redesign is expected to improve patient access and affordability.
• SC Pharma is preparing for a potential mid-April CKD launch, pending FDA approval.
• Development of an auto-injector for Frosix aims to reduce costs and enhance convenience.

Financial Results

• Medicare patients constitute 70-75% of Frosix users, with 15% commercial and 10% Medicaid.
• The Medicare redesign is expected to increase Gross-to-Net (GTN) by 10-20%.
• Fill rates rise to 60% when patients face low co-pays.
• Patient out-of-pocket costs under Medicare have been halved to $2,000.

Operational Updates

• 75% of Frosix usage occurs pre-hospitalization, with significant use by Class IV patients.
• Kaiser has adopted Frosix for use by home health nurses, enhancing post-hospitalization care.
• SC Pharma is expanding its sales force, with 90 representatives nationwide and new operations in Puerto Rico.
• The company is leveraging Integrated Delivery Networks (IDNs) to maximize value.

Future Outlook

• SC Pharma is awaiting a CKD approval decision, expected on March 6, with a launch meeting planned for mid-April.
• An auto-injector sNDA submission is targeted for mid-2025.
• The company is preparing comprehensive launch strategies, including training and promotional development.

Q&A Highlights

• SC Pharma is focusing on broadening Frosix’s use beyond emergent situations.
• The Medicare redesign is anticipated to be a significant growth driver in the latter half of the year.
• IDNs are expected to play a major role in SC Pharma’s growth strategy.

For a detailed account of SC Pharmaceuticals’ presentation, refer to the full conference call transcript below.

Full transcript - TD Cowen 45th Annual Healthcare Conference:

Stacy Ku, Biotech Analyst: So, we’re nearing the end of when I can say good morning to everyone, but thanks so much for joining us on our forty fifth annual healthcare conference. I’m Stacy Ku, one of the biotech analysts. I’m here with my colleague, Vish Shah, and we’re very happy to be hosting SC Pharma’s CEO, John Tucker, and also in the crowd. Thanks so much to Kate.

So very briefly to start, obviously, you’ve given some, a bit of an overview as we think about Frosix in ’24. But but but as we before we get into those details, it’s been about a year into the Frosix launch. You all have been very proactive about talking through kind of the 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. So just talk about your major learnings and and what’s been most encouraging.

John Tucker, CEO, SC Pharma: Yeah. Well, thank you first for 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, yeah, still the most important thing is how fast patients are are having relief. You know, we hear, you know, within sometimes thirty minutes, patients who’ve been struggling with fluid overload for for some of them for years are are feeling better. So 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 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 it’s 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 prehospitalization where, you know, the patient is having fluid overload. They come in to see the doctor, call the doctor, and the doctor is 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 pharosis kind of finish the job at home. Kaiser just implemented a, as part of their protocol, all home health nurses now are detailed and are using 406 in the patients at home. So home health for especially an IDN makes a lot of sense.

So those are some of the learnings. We’ve also learned better how to service the patients and and and the physicians. We changed our hub. Always a hard thing to do. We did it to increase, you know, patient satisfaction, physician satisfaction.

We’re seeing more and more docs now on e prescribing, which again removes the friction that’s 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. So, just so many learnings.

Stacy Ku, Biotech Analyst: Okay. Wonderful. And again, to your point, our consultants do tell us that the Frozick’s target mark is easily identifiable. They know these patients well. They tend to be high flyers and a touch more severe, which does lead to our next question, which is how is the ongoing expansion to Class four?

John Tucker, CEO, SC Pharma: Yeah. So in Class four, so it’s about ten percent of the patients, roughly ten percent of the patients, but they’re the highest they’re the highest need patients. So we’re we’re seeing, in q four, we haven’t put this out there yet, but it’ll be more than ten percent of our patients will be class four. Also, their script sizes are larger. You know, when you see a class two or class three patient, it’s probably four or five units.

The class four patients can be 12 units. So our average units will go up to probably six or seven this last quarter. That’s driven primarily by class four patients. Okay.

Stacy Ku, Biotech Analyst: Where do you think this split could be to evolve over time as we think about class four versus some of the other less severe patients?

John Tucker, CEO, SC Pharma: So the the class four 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. So part of the IDN strategy, is is around the heart failure clinic. So we think we think over time, the the class four patients now we’re not gonna have all the data because with the IDNs, the the issue with the IDNs, you don’t get the data to break it out by class two, class three, class four. We think it’s twenty five percent, of of of at the end of the day, they’ll be about twenty five percent of the patients will be class four.

Stacy Ku, Biotech Analyst: Okay. Understood. And, 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 four edition. Is that is that helping you all in terms of your outreach?

John Tucker, CEO, SC Pharma: Yes. So, when we go into heart failure clinics without the class four indication, we originally right when we launched, docs were writing class four scripts and they were getting bounced back. They were not they were not covered. It was on the label. And so we we kind of had to pull back a bit from the heart failure clinics because a lot of their patients are class four.

They’re concentrated there. So what the class four has allowed us to do is really go into these clinics and be able and be able to detail them. So, yeah, it’s it’s given us access into clinics.

Stacy Ku, Biotech Analyst: Okay. Any any additional commentary? I know I know we’re we’re, we’re ahead of earnings. So

John Tucker, CEO, SC Pharma: So, yeah, I I think, you know, one thing that we’ve really been focusing on, is is really expanding the use case, not just preapproval, postapproval, but don’t wait till the very end right before the ambulance is coming to prescribe for o six. A, it narrows your market. B, any friction in getting the script, you’re gonna have a patient that doesn’t get ferrostic sent up in the hospital. So we published some data in October, that our at home study that really showed that if you treat these patients when they start first start having issues with fluid overload and that oral first stops working, instead of the doubling the oral, instead of doing all these other things, thirty seven percent reduction in hospitalizations. The Dipsania scores at day one, day three, day seven, all were dramatically lower.

So that really helps us in in convincing these physicians. Don’t wait. Get these patients feeling better. Don’t wait till they’re so sick they have to go to the hospital. And I think we’ve been really successful in doing that, and that that’s really an opportunity for growth moving forward.

Stacy Ku, Biotech Analyst: Okay. And, of course, the KOL feedback has always been remarkably consistent, very positive. But, 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. So maybe talk about that. You alluded to the kind of the hub.

It’s up now and running. You’re doing more e prescribing, but are clinicians now able to get a sense of which patients are covered? Are you now working on the co pay dynamics? Obviously, these are patients that they want to prescribe for 62 multiple times a year. So just maybe talk through some of that those dynamics.

John Tucker, CEO, SC Pharma: Yes. So, you know, our patients are about 70%, seventy five % Medicare, and then probably 15% commercial, 10% Medicaid. And Medicare, there’s, you know, two books of business. There’s Medicare Advantage where our patients have hundred dollar or lower co pays, and then there’s kind of traditional PDP, prescription drug plan, which is, where they they tend to have high out of pockets. Right?

These are, and that’s and that’s a bit bit of a headwind for us. Right? If a patient has, you know, a $2,000 co pay, there’s a good chance we’re we’re not gonna get that patient. Now, a a big change this year is a Medicare redesign where patients out of pockets now, their max is $2,000 Last year, everyone said the cap was $32.50. It was really 4,000.

So Medicare has cut their their out of pockets in half to $2,000 That’s massive for us. Now everyone says, well, how about your GTN? Well, yeah, the GTN will go up. It’s gonna go up, you know, 10% in the initial phase, 20%. But our GTN in 02/2018 I mean, February 2024 was around 18%.

We think that we haven’t had the discount, and now we have to because of the mandatory. But the access to these patients, we see any time the patients have low co pays, such as what we saw in December, that their our fill rate goes up to about sixty percent. And more importantly, there’s like a halo effect. Doctors will write more if they know their patients can receive it. If a if a doctor doesn’t think a patient can afford it, they won’t write it.

They won’t recommend it to their patient. And what we’re gonna see this year are patient co pays on the PDP side go down eventually to zero, after they get through their out of pocket. So we’re really excited about how the redesign is gonna impact us.

Stacy Ku, Biotech Analyst: Okay. Wonderful. So obviously, I’m sure heads down, still focused on heart failure, and and class four. But, March 6 is is tomorrow, Thursday. And 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 and we’ll get into some additional questions.

John Tucker, CEO, SC Pharma: So we feel we feel good about it, you know, and we’re we’re preparing for launch. So, we have a launch meeting scheduled if we receive approval, next month mid mid April, to get all the reps trained, the new promotional pieces, all of that. So we’ve done all of our market research. We’ve engaged KOLs. We’ve identified, the key nephrology networks.

They’re very network oriented, and we’re already talking to to to the networks. We have we have right now a heart failure indication. So if a nephrologist is taking care of a patient with edema caused by heart failure and chronic kidney disease, that’s on label. So we’ve 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, and it’s about threefold the awareness already in nephrology. So, we’ll have the marketing material done. We’ve done the KOLs. We have our speakers deck ready to go.

We’ll we’ll hopefully receive, you know, the the PI tomorrow, with the approval. Hopefully, be in the field Monday with the with the PI detailing and then full full launch coming out of our launch meeting in April.

Stacy Ku, Biotech Analyst: Okay. And it sounds like there’s gonna be a similar focus on the in person training, making sure enterprises are able to use the product.

John Tucker, CEO, SC Pharma: We’ll need to do that as well. We’ll we’ll need to set them up. We’ll do the in services. We’ll set them up on the Ferosix Direct. They’re they’re very IDN focused as well, so we will be working with their their IDNs if we’re not already in there, so they can prescribe through their through their pharmacy and their IDN.

Stacy Ku, Biotech Analyst: Okay. Wonderful. So understand that the current Salesforce, outreach to nephrologists is for patients that have concomitant heart failure and CKD, but what early learnings are you gleaning from these interactions, and what are common questions that that that the Salesforce is getting?

John Tucker, CEO, SC Pharma: It’s the same product and and the messaging is it’s pretty similar, but it there there are some big differences. You know, nephrologists pretty much deal with fluid all day. It’s what they’re doing. They’re more aggressive in in how they’re treating. They’ll they’re not as worried about a high dose or a eighty milligram, one hundred percent bioavailable dose.

That doesn’t doesn’t scare them at all. They they think in terms of of really the big differences drying them out. You don’t hear that from a a cardiologist. I’m gonna dry them all the way out. You hear it from nephrologists.

I gotta dry them out. I gotta dry them out. I gotta dry them out. So, you know, we’re predialysis, but they wanna get them dry. The best way to get a patient with edema dry is for o six.

They also don’t have access to IV clinics as much as a cardiologist do. They do do some of that, but they have to use the hospital really for IV. So the fact that they want to dry them out, the fast that Pharosix is a % bioavailable. We think the messaging, for the for the nephrologist is even a little cleaner.

Stacy Ku, Biotech Analyst: Okay. And is it a similar emergent type of scenario when a patient comes and needs to kind of get, some type of LASIK, IV LASIK or PHOSIX?

John Tucker, CEO, SC Pharma: It’ll be for those patients. But again, we need it to be for more than just those patients. When that 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 gonna work. So, we’re gonna try to move that up, not just emergent in in in kidney disease, but as soon as they see some diuretic resistance.

Stacy Ku, Biotech Analyst: Okay. What what an additional level of education, you kind of alluded to it a little bit, is do you think is necessary? There’s a lot of different there’s a diversity in nephrologists and prescribing habits, and maybe even ages. So just help us understand how how how you’re thinking about that.

John Tucker, CEO, SC Pharma: It is different from what what we’ve seen in the market research, and market research is market research, so take it with a with a grain of salt. But, I think what when we started doing the market research, we understood that, you know, protocol guideline development. So we’ve actually worked with a couple major nephrology practices, group practices, and networks to create, guidelines and protocols. And now we’re we’re, again, to be compliant, it has to be requested, but we’ll send them the protocols that other nephrology practices are using. Really for that understanding, that education on on how and why to use, a a phorosick.

So that’s been a big initiative for us. Okay. And

Stacy Ku, Biotech Analyst: you all, do you have plans? Is there anything like a registry study or any additional information that could be helpful?

John Tucker, CEO, SC Pharma: Yeah. A registry study is something we’re definitely planning on doing, in in both heart failure and kidney disease, and there’s a lot of things you can do with that from publications to creating data. We’re also, doing a number of investigative sponsored studies now. The Kaiser one, obviously, is a huge one. Now that’s not really an ISS because they’re buying commercial drug, but they’ll be publishing the results of their of their home health initiative.

And then there’s the ISSs we’re doing and then, eventually, a registry study as well.

Stacy Ku, Biotech Analyst: Okay. And remind us, potential number of regions that you need to target for nephrology versus cardiology or heart failure?

John Tucker, CEO, SC Pharma: Yeah. Regions, yeah. We’re yeah. It’s a it’s a national launch. There’s 90 we have 90 reps, right now.

So we’re we’re in every major market. We’re opening Puerto Rico this this month, which will probably be our biggest heart failure territory. So we’re pretty excited about that. It takes a long time, but we’re we’ve got that done. So we’ll be we’ll be nationally.

We are also expanding our key account group, which has you know, our IDN use has has has really exploded here in the last couple of quarters. So we think that we’re getting in these contracts, we’re getting stocking, and now we’re gonna use that to pull it to really pull it through. And nephrology is a big part of that.

Stacy Ku, Biotech Analyst: Okay. Just because you brought it up, and we do wanna kinda talk about the big picture for CKD. Mhmm. For for IDNs, are you expecting that to accelerate, expecting that to grow? That’s gonna be kind of a major contributor for you all?

John Tucker, CEO, SC Pharma: It it will be. And it’s it kinda makes sense. Right? When you you look at the kind of the Medicare market and we focus a lot on Medicare, obviously. You know, you you have the PBMs that are the gatekeepers and they want huge discounts and they don’t really see the value of the medical offset, right, But the IDN does because the IDN typically, most IDNs, have that hospitalization cost as well.

So they can look at the big picture where the traditional PDP, you have a PBM that doesn’t see the medical offset. All they care about is rebates. So that’s why the IDNs really are gonna be a big part of our business moving forward.

Stacy Ku, Biotech Analyst: Okay. Perfect. So back to CKD, obviously, we’ve talked about kind of the short term plans and opportunity, but but big picture, long term, what’s your view on CKD relative to heart failure?

John Tucker, CEO, SC Pharma: So we we look at it a little differently. We look at what contribution will come from nephrologists versus what will come from cardiologist or heart failure specialist, because we do know that the nephrologist is treating heart failure as well. You know, heart and the kidney work work together. A lot of cardiologists will allow the nephrologist to manage the fluid overload with a heart failure patient. So we think thirty five to forty percent of when we’re at peak will be from nephrology.

Stacy Ku, Biotech Analyst: Okay. And and also to to your to your point in in the past, I believe you said kinda the approval for CKD and nephrology presence lifts both both boats. Is that fair?

John Tucker, CEO, SC Pharma: Correct. Well, it’ll it’ll lift the heart failure, boat as well. You know, 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. Yeah.

Is it from their kidney or from their heart? You don’t have a kidney indication. So this allows us to to go into that office. If your patient has edema, doesn’t matter if they have heart failure, kidney, both, you can write for o six now.

Stacy Ku, Biotech Analyst: Okay. So we do wanna make sure we spend some time, on the auto injector. So SCP one one one, you all have not been marketing it to KOLs. But when we inevitably bring it up, we we are getting some high level of of kind of enthusiasm even for those that were maybe a little bit more hesitant to use, your Onpro, OnBody device. So let’s let’s talk about first maybe some details of of disclosures you’ve shown so far.

How are you what’s the profile, administration time, what are the differences, and and and we’ll go from there.

John Tucker, CEO, SC Pharma: Again, I’ll go back and say that the OnBody Infuser 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 7070%, but also, it’s a it’s a two and a half second push. The patient just takes the 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 gonna be so much more convenient for patients.

But we do know, and 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 missus 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 if she can wear it. And then so those are the patients without caregivers, and then there are some patients where the doctor says this patient’s pretty active. They’re not gonna knock this off in the next five hours.

So we do think, yes, it flows to the bottom line on our COGS, but it really aids in penetration. I mean, we’re we’re hesitant to to be talking about it in the field because we want them to use a current product, but it it it’ll have a huge impact on the market when we when we launch it.

Stacy Ku, Biotech Analyst: Okay. And how do we reconcile maybe the five hour infusion? Because we’ve been getting some questions to to that two second push.

John Tucker, CEO, SC Pharma: Yeah. It’s it’s just gonna be the PK data. If 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, you know, the the threshold to approval and really the threshold to use by physicians is showing the PK equivalent to the IV. We did that with a five hour infusion, and we’re now doing it. You know, the the skin acts as a buffer and and and slows down the infusion compared to an IV.

It’s not the same as an IV. The it’s 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.

Stacy Ku, Biotech Analyst: Wonderful. So what are the remaining gating steps, as it relates to potential for mid twenty five sNDA submission?

John Tucker, CEO, SC Pharma: So we we just need to finish, you know, that we we’ve got almost two and a half years of stability on the drug product, which was the big challenge to get eighty milligrams in a one 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. So 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 in the auto injector. So we we should have that, data soon and then be ready to file midyear.

Stacy Ku, Biotech Analyst: Okay. Wonderful. So let’s go near term again, as it relates to Ferosix, and what we’re seeing in early twenty five. And, of course, wanna be cognizant that you we’re we’ll stick to the previous disclosures that you all have made. How is kind of that Medicare IR redesign playing out in the short term?

I think you’ve talked, about the long term benefits, but just help us understand the cadence of this year.

John Tucker, CEO, SC Pharma: Yes. So, you know, the redesign, there was, you know, a couple, I guess, for us, three major components of it. One was the biggest thing, which was the the patient’s cap going down from the 4,000 to the 2,000. That that’s gonna 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 co pays, to have access. We haven’t had that. So we we think the trade off between, excuse me, the $2,000 out of pocket and the 10% to our GTN, it is so worth it. Just in our fill rates, every time we see patient co pays 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 twelve months.

That enrollment was supposed to start October fifteenth of last year. From what we can see, it really didn’t start. So we haven’t seen just in our book of business the smoothing impact we thought we were gonna see. We do see the $2,000 cap, but we don’t we don’t see as much smoothing. It’s it’s happening, but it’s happening, I think, slower than what we thought and clearly slower than what CMS thought.

CMS thought seventy percent of the patients would enroll in smoothing. We might get there by the end of the year, but it’s it’s on track. But what we do see is when a script comes in and even if it’s a a patient in PDP with a $2,000 co pay, we tell them our our hub tells them, listen, you pay $2,000 now, you’ll have no co pays for the rest of the year on any medication. And if a patient has a $2,000, they’ll do that. So, so again, we think, again, for the year, it’s really gonna be, a a real tailwind.

In q one, 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.

Stacy Ku, Biotech Analyst: Okay. Got it. So we’ll see how IRI Resend plays out in terms of cadence of quarters. But again, to your point, IDN should be a greater contributor over the course of the year. Now for ’25 and, again, sounds like consensus is in kind of the low to mid eighties, for millions.

What are your views there, very high level, and and maybe potential drivers for sales Yeah. As we think about this year?

John Tucker, CEO, SC Pharma: We’re we’re two months in, so it’s it’s a little early. And 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 we feel strongly in looking at what we’re hearing and seeing that it’s beneficial for us. So, you know, we haven’t given guidance yet. I think we wanna see more of how the impact of the redesign goes, make sure we get the the kidney approval.

But I think where we’re sitting here today, we feel we feel comfortable with those numbers.

Stacy Ku, Biotech Analyst: Okay. And potential drivers of of growth?

John Tucker, CEO, SC Pharma: Yeah. There’s a lot of them. So we we expanded the sales force in Q4. It takes a quarter or two for the impact of that to happen. So 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, you know, immediately, but clearly in the second half of the year. And again, I think, for the balance of the year, especially in the second half of the year, the redesign, having patients with $0 co pays is is going to be huge for us. And again, it’s going to take some time for them to get there, but we think that’s a big driver for us. So those are those are three big drivers plus, we’ll have Class four for the whole year and continued focus on the IDNs.

Stacy Ku, Biotech Analyst: Okay. Wonderful. What a what a great recap. Well, thanks so much for your time today, and and appreciate everyone listening in.

John Tucker, CEO, SC Pharma: Thank you. Thanks, everybody.

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