Q4 2022 scPharmaceuticals Inc Earnings Call

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Speaker 1: What I and.

Speaker 2: Greetings and welcome to the SC Pharmaceuticals fourth quarter and full year 2022 earnings conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star 0 on your telephone keypad. If you have any questions, please press star 0 on your telephone keypad.

Speaker 2: As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, PJ Kelleher.

Speaker 2: Thank you, Peter. PJ, you may begin.

Speaker 3: Thank you operator.

Speaker 3: Before turning the call over to management, I would like to make the following remarks concerning forward-looking statements. All statements on this conference call, other than historical facts, are forward-looking statements with the meaning of the federal securities law, including, but not limited to, statements regarding SC Pharmaceuticals' expected future financial results and management's expectations and

Speaker 3: of future performance and may involve and are subject to certain risks and uncertainties and other important factors that may affect business, financial conditions, and other operating results.

Speaker 3: These include, but are not limited to, the risk factors and other qualifications contained in SC Pharmaceuticals annual report on Form 10K.

Speaker 3: quarterly reports on Form 10Q, and other reports filed by the company with the FCC to which your attention is directed.

Speaker 3: Actual outcomes and results may differ materially from what is expressed or implied by these four looking statements.

Speaker 3: Any forward-looking statements made in this conference call, including responses to your questions, are based on current expectations as of today, and SC Pharmaceuticals expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

Speaker 3: It is now my pleasure to turn the call over to Mr. John Tucker, Chief Executive Officer of F.P. Pharmaceuticals. John ? John ? John ? John ? John ? John ? John ? John ? John ? John ? John ? John ? John ? John ? John ? John ? John ? John ? John ? John ? John ? John ? John ?

Speaker 3: Thank you, PJ, and thank you to everyone listening to Zach Noom's call and webcast.

Speaker 3: This afternoon, I am pleased to provide an operational update on the initial stages of the Perot Six commercial launch. Before I turn the call over to Rachel Notes, our newly appointed Chief Financial Officer, for a review of our financials.

Speaker 3: While it has only been a few weeks since we announced the launch and commercial availability of for 6 on February 20th initial interest model patients providers and payers is very high. Reflecting the important role that can play in the heart failure treatment paradigm.

Speaker 3: either pre-hospital admission or post-discharge. As we have said before, we believe Ferrocyx is a true game changer, as it allows patients, for the first time, to access IV-equivalent furosemide based on similar systemic exposure and diuresis in the comfort of their own home.

Speaker 3: Our own proprietary research suggests that among heart failure specialists, cardiologists, and nurse practitioners, intent to prescribe Perosix ranges between 93 and 96 percent, and intent to prescribe within six months ranges between 86 and 89 percent.

Speaker 3: This research underscores the openness to a different approach to the treatment of heart failure.

Speaker 3: We believe we are well financed and have assembled a highly experienced commercial team that hit the ground running, making contact with top tier hospitals, clinics and physicians in their respective territories. I'm confident that we will see a strong update and quickly get for us to the many heart failure patients. We stand to benefit from it.

Speaker 3: Taking a step back or for the benefit of those maybe new to the story, in October of 2022, we received FDA approval for Ferrocex, a proprietary formulation of ferrosemide delivered by an on-body infuser, the outpatient treatment of congestion due to fluid overload. Hell, I am finally the Regent that entropy will Wolfenstein- womb or the Discovery-income-related transferiens- killingmm the

Speaker 3: and adult patients with New York Heart Association, class two and class three chronic heart failure.

Speaker 3: Paroxys is not indicated for use in emergency situations or in patients with acute pulmonary edema.

Speaker 3: The Perosix Infusio will deliver only an 80 milligram dose. We believe this represents a significant advancement in the management of heart failure, with the potential for improved outcomes for patients, and material cost savings to healthcare payers, most notably the Centers for Medicare and Medicaid Services.

Speaker 3: who represent Medicare, the single largest payer for heart failure related medical services.

Speaker 3: Porosamide is the most widely used oral and parental diuretic available for patients with congestive heart failure. But the bioavailability of all porosamide decreases and becomes highly variable during episodes of worsening symptoms. As symptoms worsen, patients are often hospitalized to be treated with IV porosamide.

Speaker 4: By contract.

Speaker 4: Ferrocyst allows patients to access IV-equivalent ferrocynide based on similar systemic exposure and diuresis.

Speaker 4: in the comfort of their own homes.

Speaker 4: Ferro6 is administered subcutaneously with the West Pharmaceutical Services SmartDose on-body drug delivery system technology, delivering an 80 mg dose over a period of 5 hours.

Speaker 4: Heart failure is a significant financial pain point for both healthcare payers and hospitals. It has been estimated that up to 90% of patients presenting to the emergency department with symptoms of worsening heart failure are admitted to the hospital and 50% of these admissions committees potentially avoided.

Speaker 4: The average cost of a heart failure related hospital admission for Medicare patient is nearly $19,000. It is no surprise that the Centers for Medicare and Medicaid Services has put significant resources in place to look for solutions to this problem. Treatment of heart failure is estimated to be 33% of annual Medicare Part A.

Speaker 4: while CMS reverses just 3.9 days under the current DRG.

Speaker 4: Hospitals also face exposure to financial penalties resulting from readmissions under the hospital readmission reduction program which includes heart failure as one of its focused conditions.

Speaker 4: A clinical development program is focused on the safety and efficacy of Ferro6 as well as the pharmaco-economic benefits to the system. A prospective clinical trial, Freedom HF.

Speaker 4: without positive results in July of 2021.

Speaker 4: The study design focused on select patients who presented to the emergency room with a worsening heart failure event and were treated with neurosis at home as opposed to being admitted to the hospital.

Speaker 4: The results of the study were patients treated with cirrhosis had heart failure related costs that were lower by an average of $16,995 versus historically matched comparators.

Speaker 4: And this result is achieved with a very high rate of statistical significance with a p-value less than 0.0001.

Speaker 4: While this analysis excludes the cost of Ferro6, since pricing had not been established at the time of the study readout, the conclusion remains unchanged.

Speaker 4: More recently, we announced positive results from a Phase II pilot study at home, HF.

Speaker 4: that compared Parosix with a treatment as usual approach in chronic heart failure patients presenting to a heart failure clinic with worsening congestion requiring augmented diuresis.

Speaker 4: Among the key findings, subjects randomized to Ferosix had a 37% reduction in the risk of a heart failure hospitalization at day 30 relative to patients randomized to treatment measure as well.

Speaker 4: We are pleased with the results of these two studies, which added significantly.

Speaker 4: the growing body of clinical and pharmac economic evidence favoring ferrosis versus the current standard treatment protocol.

Speaker 4: The market opportunity for Ferro6 is significant. In the US alone, there are estimated to be 6.7 million adults suffering from heart failure, resulting in 4 million heart failure events annually.

Speaker 4: Of those, we believe 2.1 million episodes can be effectively addressed by neurosis.

Speaker 4: If we assume $3,300 per episode, which is four doses of Ferrosics, we have the potential to access a market opportunity that is nearly $7 billion.

Speaker 4: And again, this is in the US alone. There are a total of 15.8 million adults suffering from heart failure if we include the other G7 countries.

Speaker 4: Now to the launch. We put a strong commercial team in place that is led by Steve Parsons, our Senior Vice President of Commercial.

Speaker 4: We have 40 field territory sales representatives, fully trained in conducting face-to-face in services at hospitals, doctors' offices, and heart failure clinics.

Speaker 4: targeting approximately 150 to 200 HCPs in 10 hospitals per territory. InSurfaces provide HCPs with training and prescribing instructions for Ferosix designed to ensure office readiness.

Speaker 4: Demo kits to train patients are provided at the completion of each in-service.

Speaker 4: The focus on the in-surface is crucial to ensuring effective use and training on 4.06.

Speaker 4: Our sales force has conducted approximately 307 in-services to date with many of these in-services lasting one to two hours as physicians desire to have training done throughout the entire office or clinic.

Speaker 4: This reflects the interest in forensics by healthcare providers. The sales team is a specialized force that can target top hospitals and clinics efficiently and effectively. They are focused on building strong relationships with the key constituencies at these clinics through an educational and consultative approach.

Speaker 4: Depending on the launch trajectory, we stand ready to add more reps in the field as needed to maximize clinic and patient access to Ferro6.

Speaker 4: In terms of distribution, we are pleased with the seamless functioning of our distribution process thus far through our strategic partnership with Cardinal Health as our third party logistics provider.

Speaker 4: Cardinal is working well with our three specialty pharmacy partners, including our main specialty pharmacy, Biomatrix.

Speaker 4: Cardinal has shipped initial inventory to the specialty pharmacies, which will be recognized as revenue in the first quarter. As a reminder, we recognize revenue when Perosix moves from Cardinal to the specialty pharmacies.

Speaker 4: So Q1 revenue will reflect initial stocking at the specialty pharmacies.

Speaker 4: We have already seen initial patient prescriptions being filled and shipped to patients next day.

Speaker 4: Ferro6Direct, our reimbursement support hub, provides benefits, investigations, or physicians to determine insurance coverage and patient out-of-pocket costs. Our specialty pharmacy partners provide device training with patients and are available 24 hours to answer questions about the use of Ferro6.

Speaker 4: From a marketing perspective, we have engaged in a broad, multi-channel market awareness campaign to drive brand awareness, adoption, and commitment.

Speaker 4: This program encompasses many different activities, but some of the key ongoing activities include KOL engagement and development, conference appearances, print and electronic collateral, and the development of both provider and patient websites, among other clinical tasks.

Speaker 4: In terms of reimbursement, we are pleased that all Medicare Part D and Medicaid beneficiaries will have reimbursed access to Furosix since day one of the launch.

Speaker 4: We estimate that approximately 60% of all heart failure patients will have fixed tier co-pays of $100 or less.

Speaker 4: We continue to meet with many large national and regional Medicare Part D and commercial health plan, and those discussions have been productive.

Speaker 4: Our goal remains to achieve 75% of patients with access to Ferro6 under fixed-tier copays by the end of this year.

Speaker 4: Turning to our balance sheet, in November we were able to add $50 million of gross proceeds through a public offering of common stock.

Speaker 4: This fall's $100 million secured debt facility that we announced with Oaktree Capital Management in October .

Speaker 4: 50Million of which was made available to us upon the signing of the agreement.

Speaker 4: The remaining $50 million will be made available in two additional $25 million tranches based on the achievement of pre-specified commercial milestones.

Speaker 4: With these financings, we believe we are well-funded to execute a very successful launch.

Speaker 4: Finally, in December , we announced the promotion of Rachel Noakes, the position of Chief Financial Officer.

Speaker 4: Rachel brings tremendous experience and leadership to the CFO role, and her promotion maintains organizational consistency and an important time for the company.

Speaker 4: We are excited to celebrate this well-deserved recognition of our expertise and contributions.

Speaker 4: I will now turn it over for her comments. Rachel.

Speaker 5: Thank you, John . As of December 31, 2022, we held $118.4 million in cash, cash equivalents, restricted cash, and investments.

Speaker 5: Our year end cash includes net proceeds from the successful 50M dollar equity offering that we completed in November . Plus the 1st, 50M dollar tranche under our debt financing agreement with Oaktree. We did use some of the proceeds from the Oaktree transaction to prepay all amounts due under the credit facility that was outstanding at the time.

Speaker 5: Now I will cover a few income statement items. We reported a net loss of $9.2 million for the fourth quarter of 2022, compared to a net loss of $7.3 million for the comparable period in 2021. For the full year 2022, we reported a net loss of $36.8 million.

Speaker 5: million for the fourth quarter of 2022 compared to $4.5 million for the comparable period in 2021. The decrease was primarily due to a decrease in clinical study activities, device development costs, and regulatory consulting.

Speaker 5: For the full year 2022, we reported research and development expenses of $15.5 million compared to $16 million for the full year 2021.

Speaker 5: General and administrative expenses were $7.2 million for the 4th quarter of 2022, compared to $2.2 million for the comparable period in 2021.

Speaker 5: The increase was primarily due to an increase in employee-related costs, commercial preparations, and legal costs.

Speaker 5: For the full year 2022, we reported general and administrative expenses of $20.6 million compared to $9.8 million for the full year 2021. The increase was primarily due to an increase in employee-related costs and commercial preparation costs.

Speaker 5: Based on our current operating plan, we expect our operating costs to increase in 2023 as we support the launch of Furofix, including investments in marketing and a field sales force.

Speaker 5: As of December 31, 2022, we had 34,257,916 total shares outstanding. That concludes the financial update. John .

Speaker 4: Thanks, Rachel. This concludes our prepared remarks. At this point, we will open the call for questions.

Speaker 2: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue.

Speaker 2: You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for questions. Thank you. Our first question is from Glenn Santangelo.

Speaker 6: said that you hope by the end of this year you hope to have maybe 75% of the patients under contract with with the copay of less than $100 per and I'm not sure if I heard all that correctly I just wonder if you could just sort of walk us through again in a little bit more detail where you stand right now you know with all your part D negotiations just so I can sort of put all in perspective thanks

Speaker 4: Yeah, hey, Glenn. Thanks for the question. This is John and I can actually fill in a little bit. Yeah. So we've kind of stated a number of times that our goal. For the end of the year, and it's not just for Medicare Part D. It's for all of our patients. And so again, we have a mix of Medicare Part D, which is the predominant payer, commercial, and then we also have Medicaid. So.

Speaker 4: So our goal is greater than 75% of all of the patients to have fixed-year co-pays under $100 by the end of the year. We do know now, we've been very successful. We think there's one very small plant that might have put us in the specialty tier, but our team has been really successful in keeping Ferro6 out of the specialty tier.

Speaker 4: In both commercial and Medicare Part D plans, as you know, especially tier incorporates co-insurance, which is. What we we want to stay away from so we've been successful with with getting keeping it out, especially tier. We've also gone through the P and C at all, but. But 1 of the of the major plans.

Speaker 4: and if that's successful P&T meetings at all, then we still awaiting one plan to have that P&T. We're still in active negotiations around rebates. The good thing is with Medicare Advantage.

Speaker 4: The patients will have fixed-tier co-pays of under $100. So we're still negotiating on moving those co-pays down. Our goal is a significantly lower co-pay than $100. And we'll rebate to get there, Klein. We're not going to, you know, we know the most important thing is patient affordability. So we'll be rebating.

Speaker 4: With the plans and we're negotiating with them now to lower the copay and to add to that 60%. That has has copay has copays under under 100 and try to actually get that up even even higher than 75%. That includes the commercial plans as well. And, you know, we can't say a name, but we've had a.

Speaker 4: A recent big win there where a preferred formulary status, which would bring copays. Well under that $100 on one of the two or three largest plans on the commercial side. So I don't know Steve, if you wanted to add anything to that, that was a long answer.

Speaker 4: I think it's accurate. We use $100 as the high watermark for the patients we're talking about. 60% of the patients should be at 100 or less, many of them much less. Remember, of course, that

Speaker 4: In Medicare Part D. There's a group of low-income subsidy patients. Those are dual eligibles They're lower income Medicare patients, and they'll have a copay of about ten dollars Whether they get three doses four doses five doses six doses. It's the same copay, so We use a hundred to be

Speaker 4: You know, as the high water on about 60% of the patients, there's still some others that we are pursuing, you know, improved COPEI situation, but it's a really good place to start. And we've seen, Glenn, we've seen Scripps come in for commercial Medicaid and N-4.

Speaker 4: And for Medicare Part D, and we filled all of those, we filled those scripts for all 3 of those major, major payers in the market.

Speaker 6: All right, well, I appreciate all that detail. Thanks. Maybe I could just ask Rachel a quick follow-up question. In the prepared remarks, she also talked about the number of sales reps that you have currently, and I think I missed that number as well. So I was wondering if you could just sort of give us that. And then, Rachel, I think you said that the Q1 revenues will probably be a little bit front-end loaded with some of the specialty pharmacies stocking.

Speaker 6: And then you plan to make some additional investments in marketing and the sales force. I was wondering if you could just sort of, I get it you don't want to give any guidance at this point, but maybe could you just discuss a little bit about the cadence of how the year should look and give us a sense for, you know, if one Q will be disproportionately high on the revenues and then we'll sort of tail off before we build up and any expenses, should that just be a constant.

Speaker 5: Expenses to be higher to continue to increase from 2022 because we are putting that, you know, we have now have the full commercial infrastructure. So the full. 40 person sales force as well as we continue to invest in. In marketing marketing as well. So that was really.

Speaker 4: started the end of January , so Q1 on the expense side is probably going to be lighter. And we do anticipate adding reps later in the year. We're going to give it time. So I wouldn't say it's directly linear because again Q1 will be a little lighter because the reps didn't start until the end.

Speaker 4: end of January , but it should be pretty flat except for the addition of sales reps potentially as early as Q2. As far as revenue, you know, we launched February 20th and in order to launch you had to have inventory in our specialty pharmacies. So I think when you look at Q1 revenues, you know, we've been able to launch Q1.

Speaker 4: It will be predominantly that that stocking inventory. You know, we haven't given guidance, but I wouldn't think that stocking inventory. Would preclude revenue in Q2, Q3, Q4, all of that. It's just initial stocking inventory to make sure.

Speaker 4: that the product's there on the shelf when a physician puts a script in. I hope that answers your question. Yep, that's good.

Speaker 2: Thank you. Our next question is from Nick Gasek with SVB Securities. Please proceed with your question.

Speaker 3: Hey everybody, this is Nick Gassick on for Rolando Ruiz. Congrats on the launch and all your progress so far and thanks for taking our questions. Maybe first on Furosix, could you give us a little more clarity around which external launch metrics you plan to share and which you'll be focusing on the most.

Speaker 4: This is John and I'll talk a couple of maybe Steve you can. You can add to it, you know, some of the key things. What we'll start communicating as early as as. May 2 Q1 earnings call would be kind of number of.

Speaker 4: Of new prescribers that are that are used for 6. Average length of script, which is a, which is a big thing for us. As I think we said, we, we anticipate 3 to 4. so we'll be able to report on that. It'll still be early early data, but it'll give us some directional things. Steve. What other things are. Are you.

Speaker 4: thinking of communicating orderly. We'll talk about the number of targeted heart failure hospitals and clinics that have activated with at least a couple patients on therapy. We'll talk about the number of unique patients.

Speaker 2: That have been treated so you can see the breadth of that. We'll talk a little bit more about Medicare. Part D, payer formulary wins and placement status as that as that as that arises. As we have more information, of course. That sales.

Speaker 4: So, I think those are the things Nick and I, and, you know, I'm going to, I'm going to quote that's what we're anticipating. You know, we're 3 weeks in data. I think we want to understand. What the most.

Speaker 4: What's the most beneficial things to communicate to the street? And those are the things I think you learn those are the things we're planning on now. Um, I think they could change, you know, in 2 months, but we just want to make sure we're communicating what we think are the most telling things in the progress of the launch. That's very helpful. I also had a quick follow up as well. I was wondering if you could give us.

Speaker 7: a sense of some of the commercial strategies you've been implementing to drive awareness among patients, prescribers, et cetera. Maybe which ones you've had the most success with so far.

Speaker 2: Please. Yeah, so we're doing the traditional things, you know, digital advertisements in the key targeted journals, journals associated with the Heart Failure Society of America, Heart Failure Nurses,

Speaker 2: At launch, the American College of Cardiology sent out an email blast announcing heuristics availability to about 15,000 members that are dealing with heart failure. The Heart Failure Society of America did the same thing on our behalf. We're continuing to do digital.

Speaker 2: banner ads, announcing our campaign, announcing the availability of characteristics. So it's what Big Pharma does.

Speaker 4: Omni channel marketing, like, like others do just very, very targeted towards the folks that we are. Going after in the early, early launch period and if we were, we, as you know, ran a pre launch. Brand awareness campaign, and actually we're able to measure that prior to launch and we're really impressed.

Speaker 4: With what we saw with aided awareness on the brand name and then unaided awareness as well. So it's a good baseline. We've been very. Very happy with the interest we've seen. In the field, we've had phone calls into various people in the, in the office asking if they could, they could talk to a rep that a number of inquires on the website.

Speaker 4: We've had reps in the field that have walked in and the doctor's office will tell them that they're booked. And then we talk a little bit about what we're doing and the nurse comes back and says, we're scheduling a lunch we have for tomorrow. Will you come in and do an in-service? These in-services are really key to us. We really think it's just critical that these offices and clinics know.

Speaker 4: instructions for use with videos, online videos that they can access as well as calls from the specialty pharmacy, FaceTime, you know with any questions they have. So these in-services have been great. The interest, you know, the doctors are pulling in their entire staff.

Speaker 4: Sometimes we're doing two or three sets of in-services in an office that can last one to two hours at some of the biggest hospitals from Duke to Northwestern, Emory, Washoe, I mean, just exactly where we want to be. So we're really enthused with the awareness of the product when we launch.

Speaker 2: and then the enthusiasm to talk to us when we're out there. Very helpful. Thanks for all the updates. I'll hop back to the queue. Thank you. Our next question is from Stacy Ku with Cowan. Please proceed with your question.

Speaker 5: All right. Thanks so much for taking our questions. We did have a few. So, first, you gave some background about that initial clinician outreach. Can you talk a little bit more about your goals and expectations and the clinician base? I believe you said in the past it's around 6,000 patients for the 40 reps. So, any additional details or timing would be appreciated.

Speaker 5: So that's the first question. And then the second question is around your ability to track the for the scripts from your three specialty pharmacies. So just give some really early expectations for how this month is progressing. Are you happy? And I know you've talked about the stocking inventory. So how should we just be thinking about the bowls of initial patients, especially for those clinicians that might be able to.

Speaker 5: any, I guess, very, very early initial color on where these patients are coming from. Thank you so much.

Speaker 4: Great Stacy. Thanks John . You know, so let me just sum up the questions kind of the number of doctors we're targeting. And kind of initially, what are we what are we hearing out there? And then 3 kind of patient types. So, Steve, do you want to. If you want to tackle those.

Speaker 2: Yes, so I think we shared previously, each territory have about a minimum of 150 targets up to 200. They can add those as they're making their way through the territory, learning more about who's involved in patient care, who's involved in initiating prescriptions. So anywhere from 6,000 to 8,000 would be our target list that we could see.

Speaker 2: you know, regularly. Of course, there'll be outliers where we see, you know, occasionally some people, but our commitment would be to see 150, you know, very, very routinely, many times a year, covering about 450 hospital communities. So all the docs that are in and around that hospital on the campus in their medical buildings.

Speaker 2: in their heart failure clinics. So that's the targeting. The S.R.R.X. is, you know, we get a report every day. We can see all the prescriptions every single day from our specialty pharmacy and all the different distribution centers. It comes into the central hub. And so far we're pleased.

Speaker 4: I think we're seeing, as John said, we're seeing Medicare prescriptions, we're seeing Medicaid prescriptions, we're seeing commercial prescriptions. And it's what we hope to see. Yeah, it's funny where, you know, some of the things we're seeing, we saw a prescription for 180 units the other day, which is too many really because we don't want to see that.

Speaker 4: It's a little you got to be careful what you what you see early. We are seeing like this.

Speaker 4: this group of patients where the doctors that know Ferro6 is coming have kind of teed them up and as soon as we detail them and in-service them. I think it's important to know Stacy that you just can't order Ferro6 unless you've seen us, unless we've done an in-service and detailed you on the drug. So you can't get a Ferro6 direct one.

Speaker 4: without having engaged with us. We are going to make sure that the usage is appropriate and that the patients have good experience. So we've had a lot of these in-services. They've gone well. The rest, to be able to see their whole territory, you know, it's that, you know.

Speaker 4: now. So to go back to the patient types, it is these patients that kind of have been in the queue. They'll call them in and say, you know, we have something for you now and actually, you know, put them on, put them on drugs there. So, and then obviously patients coming in on sick visits, patients that are coming back after being discharged from the hospital and patients that

Speaker 4: they know are going to be in and out of the hospital or need IV treatment, you know, every month, a couple days a month. They're going ahead and prescribing Ferro6 for those patients. So it's kind of the patient type we thought maybe with the with the six light caveat that

Speaker 4: that we didn't quite expect the bolus of patients that the doctors had queued ready to go when we walked in. So that's where we are. I hope I answered your questions.

Speaker 5: speed that little job in. That's very helpful and just to confirm before you had said in your prepared remarks you said one to two hours for your services and then you had said 300 something is the number of clinics that you've now surfaced to make sure since you it sounds like you're really taking the time to make sure.

Speaker 4: Is that correct? So that's not all the calls we made. Okay. Not all the calls. But you know, but to set up the in-service you're going to walk into the doctor's office and schedule the in-service. Now we have had opportunities where we walked in and we dropped right into an in-service, but typically you want to schedule a lunch.

Speaker 8: today.

Speaker 9: Okay, thank you for that clarification. Thank you. Our next question is from Douglas Sow with H.C. Wainwright. Please proceed with your question.

Speaker 10: Hi, good afternoon and thanks for taking the question. So, John , maybe as a follow-up, I mean, I guess when you think about this in service, what is the key? I've always felt that there are d rule and there are anti rules and Bluetooth options

Speaker 10: goal of that and you know, are you changing or potentially changing a behavior or a way that physicians might have thought about using the product but then they have the in-service and they have a better understanding of how to best deploy 406.

Speaker 4: Doug, I'll let Steve answer that. I will say this. One thing that's been interesting is that we always say it's going to take a couple calls to change a doctor's behavior. We're seeing doctors immediately after an in-service with a script. So, you know.

Speaker 4: lot of them are waiting for this and are aware of it. But you know, that's one thing that I think we've seen. And again, I think it has to do with the depth of the in-service and the knowledge of the patients and the fact that we've said all along they've used IV strength furosemide their entire career. So this isn't

Speaker 2: kind of a new molecular entity. But Steve, do you want to talk more about? No, I think that's a good insight. We have changed people's minds on where they think they would use this. They've broadened it. I think everybody comes into the the fierostics experience with, okay, I know exactly where I think I'm going to use it. I can think of a few patients.

Speaker 2: who of your roses can help? And so, the change of behavior remains to be seen, but the change of mind is definitely taking place and it's getting broader.

So that's been a good experience. And how can you say, so it's going from what to what most commonly.

Some doctors think this is going to be great to use after someone's been discharged from the hospital to prevent a readmission. Some doctors think the best way to avoid a readmission is to never have an admission in the first place. And so they're catching them on the front end. Some doctors are asking us about, you know, could they finish the job a little earlier at home, you know, once they're stabilized in the hospital? So.

I can't say everybody has the same opinion, Doug. It's just. When they hear our full story, I think we open their mind to all 3 of those potential. Potential use cases. Okay, great. Thank you so much.

Say everybody has the same opinion. Doug. It's just when they hear our full story. I think we open their mind to all 3 of those potential potential use cases. Okay, great. Thank you so much. Thanks. Doug.

Thank you. Our next question is from Naz Raman with Maxim Group. Please proceed with your question.

Hi, everyone. Congrats on a recent launch and thanks for taking our question. Just on your target hospitals and target ACPs, could you give some color on what percentage of them you've already reached out to? And it obviously sounds like the in-service points are key, but could you also talk a little about what the response rate has been to your

We have Decile 10 hospitals, we have Decile 9 hospitals, we have Decile 8, all the way down. We're focused on the Decile 7 through 10s. Of the Decile 10s, I think we've hit 90% of them so far with calling on doctors who are in and around the community. At Decile 10 hospital, we have about 30,000 people in the community.

has the most heart failure admissions and discharges in the United States relative to their peers. I think at Decile 9's we're like high 80% reach and again, we're not selling into the hospital. It's where we go fishing. It's where all the patients are so we talk to all the...

specialists in and around there. So we've, you know, the states were probably high 70s. I mean, we're, our strategy has been to focus there first and try to hit all the doctors associated, affiliated with those hospitals where we know they're taking care of heart-related patients with fluid overload. So that's been the focus so far.

I can't tell you exactly what the reach to every individual target physician is so far, but I can tell you the focus on those deaths out of hospitals. So we've made over 3,000 calls, you know, our target list is, you know, is 8,000 but you know probably 6,000 are realistic CDOT.

So, but I wouldn't say that 3000 means we've hit 50% because a lot of these calls, you know, make the call, get the in service. We're really focused on. On the big, the big clinics and the, and the, and the big prescribers early. So, you know, if we had to make an estimate right now on what percentage of our target universe we've said, I'd say it's in the.

40% range of our total targets. And again, that'll keep expanding out. But, you know, NASH, it's really important. You know, we're three and a half weeks in from our data and we need these in-services. It's obviously key. We're looking at the hit rate from an in-service to a prescription.

versus just a call and it's vastly different. So that's why we know these inservices are really important. Right, and I have just one follow-up question on the actual reimbursement. I understand it's very very early days, but relative to the scripts being written, do you have an idea of what's kind of been the fill rate for the script and how many of them require prior outs, like how many of the prior outs like seem to go through and also like what happens when...

Case you got a lot of medical necessity to the letters of medical necessities go through route route for lee seamlessly So, you know, we we have seen the prior office as we anticipated and even in our in our negotiations with with the payers Both commercial and party it's it's the right Madison it, you know, they they should have failed on oral

plan on how fast the scripts are going through. Some of them are right off the bat, instantaneously. Some of them, if it's a PA, it might take time. Medicare is a 24-hour turnaround time. We're working with a commercial plan. Some of them are fast, some of them aren't so fast.

But, you know, a lot of times with any new product and we're looking at 3, 3 and a half weeks with a new product, you know, you're going to go through a PA. You're going to go through people getting comfortable with it. You know, I think as we move forward, formula status has come online. Um, that it'll even be quicker, but but, um, again, it's just plan by plan right now.

Got it and do them do the letters of medical necessity go through? Yes, medical exceptions, we don't have to have the letters of medical necessity written.

But if there's a prior auth that is initially denied and then there's an appeal process, a very clear appeal process, usually they're asking for just more information than the doctor provided the first time. Face sheet, history and physical, whether they've gotten any labs done, blood work, things like that, that they just didn't get.

They satisfy that and more often than not it's approved. Got it. Thanks for taking my questions. Thank you.

Thank you. There are no further questions at this time. I'd like to turn the floor back over to John Tucker for any closing comments. Great, well thank you. Thank you very much. Appreciate it. We look forward to updating everybody as we move forward and everyone have a great day.

Q4 2022 scPharmaceuticals Inc Earnings Call

Demo

Scpharmaceuticals

Earnings

Q4 2022 scPharmaceuticals Inc Earnings Call

SCPH

Wednesday, March 22nd, 2023 at 8:30 PM

Transcript

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