NASDAQ:SCPH scPharmaceuticals Q1 2023 Earnings Report $2.52 -0.08 (-3.08%) As of 10:25 AM Eastern This is a fair market value price provided by Polygon.io. Learn more. Earnings HistoryForecast scPharmaceuticals EPS ResultsActual EPS-$0.30Consensus EPS -$0.36Beat/MissBeat by +$0.06One Year Ago EPSN/AscPharmaceuticals Revenue ResultsActual Revenue$2.06 millionExpected Revenue$2.60 millionBeat/MissMissed by -$540.00 thousandYoY Revenue GrowthN/AscPharmaceuticals Announcement DetailsQuarterQ1 2023Date5/10/2023TimeN/AConference Call DateWednesday, May 10, 2023Conference Call Time4:30PM ETUpcoming EarningsscPharmaceuticals' Q1 2025 earnings is scheduled for Tuesday, May 13, 2025, with a conference call scheduled at 4:30 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Q1 2025 Earnings ReportConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by scPharmaceuticals Q1 2023 Earnings Call TranscriptProvided by QuartrMay 10, 2023 ShareLink copied to clipboard.There are 11 speakers on the call. Operator00:00:00Greetings, and welcome to the SC Pharmaceuticals First Quarter 2023 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. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, P. Operator00:00:30J. Kelleher from LifeSci Advisors. Thank you. Please go ahead, sir. Speaker 100:00:35Thank you, operator. 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 within the meaning of the federal securities laws, Including, but not limited to, statements regarding SC Pharmaceuticals' expected future financial results and management's expectations and plans for the business in Ferosix. The words anticipate, believe, estimate, expect, intend, guidance, confidence, Target, project and other similar expressions are used typically to identify such forward looking statements. These forward looking statements are not guarantees of future performance and may involve and are subject to certain risks and uncertainties and other important factors that may affect SC Pharmaceuticals Business, Financial Condition and Other Operating Results. Speaker 100:01:31These quarterly reports on Form 10 Q and other reports filed by the company with the SEC to which your attention is directed. Actual outcomes and results may differ materially from what is expressed or implied by these forward looking statements. 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 It is now my pleasure to turn the call over to Mr. John Tucker, Chief Executive Officer of SC Pharmaceuticals. John? Speaker 200:02:20Thank you, PJ, and thanks to everyone listening to this afternoon's call and webcast. This afternoon, I'm pleased to provide an operational update before turning the call over to Steve Farsons, our Senior Vice President of Commercial, For a more detailed update on the early stages of the Ferosix launch and then Rachel Noakes, our Chief Financial Officer, for a review of our financials. We will then open the call up for your questions. Just two and a half months into the Pharosix launch on February 20th, We are pleased with our progress to date and early feedback suggests that Pharosix is being well received in the market. Notably, our commercial team continues to execute An important leading indicator in services with healthcare providers and have completed 518 through March 31st And have completed 743 total in services as of April 28. Speaker 200:03:13These initial in service contacts can last up to 2 hours As treating physicians often want the entire office to be educated and trained on the use of phorosis. As Steve will detail momentarily, These early efforts are working as intended as both unique prescribers and total prescriptions written are growing nicely. This supports our strong belief that Pharosix will quickly become a core part of the heart failure treatment paradigm, either pre hospital admission or post discharge as it allows patients for the very first time to receive IV equivalent furosemide based on similar systemic But by avoiding hospital admissions and readmissions, significant cost savings can accrue to commercial, Medicare Part D and Medicaid payers, as well as hospitals who face significant and worsening reimbursement pressure for their heart failure patients. As a reminder, PHAROSIX is indicated for the Pharosix is not indicated for use in emergency situations or in patients with acute pulmonary edema. The OnBody Infuser will deliver only an 80 milligram dose for Pharosix. Speaker 200:04:39Last quarter, we detailed 2 studies that we conducted that clearly demonstrate the potential financial benefits of Pharosix. One prospective FREEDOM HF focused on select patients who presented to the emergency room with a worsening heart failure event and were treated with furosics at home as opposed to being admitted to the hospital. The result of the study was that patients treated with Pharosix had heart failure related costs were lower by an average of $16,995 versus historically matched comparators. And this result was achieved with a very high rate of Since pricing had not been established at the time of the study, the conclusion remains unchanged. And the second study, The Phase 2 pilot study at home HF compared PHAROSIX with treatment as usual approach in chronic heart failure Presenting to a heart failure clinic that worsening congestion requiring augmented diuresis. Speaker 200:05:42Among the key findings, Subjects randomized to Pharosix had a 37% reduction in the risk of a heart failure hospitalization at day 30 relative to patients randomized to treatment as usual. The outcome of both studies provide a compelling picture of the benefits of Ferosix and further support the efforts of our commercial team as they work to educate treating physicians and their staff. They also provide critical as we engage with payer, pharmacy and therapeutic committees regarding reimbursement dynamics. On the topic of the payers, We continue to have productive discussions with commercial, Medicare Part D and Medicaid payers in a continuing effort to make Pharosix broadly available at the most favorable terms possible. This involves not only securing initial coverage of ferrosix, but also working to have a place on a formulary tier that would be affordable to most patients. Speaker 200:06:36We previously indicated that approximately 60% of all heart failure patients can access for our 6 under steer co pays of $100 or less, and we believe that over time we can increase this to 75% Speaker 300:06:48or more. Speaker 200:06:51Reflecting our continued progress, we were recently notified by a top 5 national health plan that Pharosix will be placed in a preferred formulary status across all of its commercial plans effective June 1. We regard this as a significant positive reimbursement development And we remain in discussions with this payer regarding its Part D plans with the goal of securing similarly favorable formulary placement for its Medicare beneficiaries. As mentioned, we are engaged with many other health plans and we hope to have several more announcements like this in the months to come. In addition, we are also recently informed that we will obtain national Medicaid coverage of Ferrosix effective July 1, 2023. The market opportunity for Pharosix is significant. Speaker 200:07:35We believe it is worth reiterating. In the U. S. Alone, there are estimated to be effectively addressed by Pharosix. If we assume $3,300 per episode, which is 4 doses of Pharosix, We have the potential to access a market opportunity that is nearly $7,000,000,000 And again, this is in the U. Speaker 200:08:02S. Alone. There were a total of 15,800,000 adults suffering from heart failure if we include the other G7 countries. At this early stage, we are seeing a wide range of doses up for O6 per prescription from 2 to 12 as this is at of the treating physician and some patients require more aggressive interventions than others. Finally, we are well funded with more than $116,000,000 Cash, cash equivalents and short term investments as of March 31, providing us with ample resources to continue to execute on our commercial plan. Speaker 200:08:36At this point, I'll turn the call over to our Senior Vice President of Commercial, Steve Parsons for a deeper dive into our early launch metrics. Steve? Speaker 400:08:45Thank you, John. As John indicated, well, it has only been about 2.5 months since we announced the launch and commercial availability At Purosix, on February 20, we are pleased with our initial progress. I'll start with an update on our commercial team. We currently have 41 field territory sales representatives with 3 additional reps expected to join by the end of May for a total of 44. They are conducting face to face in services at hospitals, doctors' offices and heart failure clinics. Speaker 400:09:19We stand ready to add more as demand patterns for pherosics continue to emerge. Targeting 150 to 200 healthcare providers and 12 hospitals per territory in services provide healthcare providers with training and prescribing instructions for Ferozix designed to ensure office readiness. Demo kits trained patients are provided at the completion of each in service. The focus on the in service is crucial to ensuring effective use and training on PureSec. As John mentioned, our sales force conducted 518 in services as of March 31st have completed 743 total in services as of April 28. Speaker 400:10:08Many of these in service are lasting 1 to 2 hours as physicians desire to have training done throughout the entire office or clinic. This reflects the interest in Pareosix by healthcare providers. This sales team is a specialized force that can target top clinics and doctors' offices efficiently and effectively. They are focused on building strong relationships with the key constituencies at these clinics through an educational and consultative approach. And while it is still early, we will be ready to add more reps in the field as needed to maximize the clinic and patient access to the ROCCs. Speaker 400:10:51The early results are encouraging. Through March 31, we had 194 total prescribers with a total of 381 prescriptions written and 161 prescriptions filled by the last day of the quarter. As of March 31, we had 152 prescriptions still pending. The vast majority of the balance of prescriptions pending are either due to prescriptions doctors have written that are queued and ready for patients or prescriptions still in progress with payers. We continue to move pending prescriptions into the filled bucket with each day. Speaker 400:11:33We have a small number of prescriptions abandoned And the reason for these cancellations are varied, ranging from patient being unreachable, hospitalized or deceased. There have also been a small number where the patient's co pay was a little too high. As we've already seen so far in April, We would anticipate that the difference between prescriptions written and filled will narrow as ferrosix is placed on more health plan formularies, expanding access for patients and lowering patients' out of pocket expense. At the moment, the average number of doses per prescription is slightly higher than 4, but we continue to believe 4 doses per prescription to be the right number long term. In terms of distribution, As we indicated last quarter, we are pleased with the functioning of our distribution process thus far through our strategic partnership with Cardinal Health as our 3rd party logistics provider. Speaker 400:12:41Cardinal is working well with our 3 specialty pharmacy partners, including our main specialty pharmacy, BioMatrix. Cardinal has shipped initial inventory to the specialty pharmacies, which is reflected in our Q1 revenue. As a reminder, we recognize revenue when furosix moves from Cardinal to the specialty pharmacies. Grosix direct, our reimbursement support hub, provides benefits investigations for physicians to determine insurance coverage and patient out of pocket costs. Our specialty pharmacy partners provide device training to patients and are available 24 hours a day to answer questions about the use of HERO6. Speaker 400:13:27From a marketing perspective, we are engaged in a broad omni channel market awareness campaign to drive brand awareness, adoption and commitment. 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 critical tasks. Overall, although we still have a lot of work to do, we are pleased with our early progress and the trajectory that we are on. That concludes my update. I would now like to turn the call over to our CFO, Rachel Noakes for a financial update. Speaker 400:14:13Rachel? Speaker 500:14:15Thank you, Steve. We generated net product revenue of $2,100,000 during the Q1 of 2023 and the cost of revenue was $600,000 yielding a gross profit of $1,500,000 One quick note for Q1, the cost of revenue excludes inventory that was expensed prior to FDA approval in October of 2022. Research and development expenses were $2,100,000 for the Q1 of 2023 compared to $4,300,000 for the comparable period in 2022. The decrease was primarily due to a decrease in clinical study and medical affairs costs, employee related costs, device and pharmaceutical development costs and quality and regulatory costs. Selling, general and administrative expenses were $10,900,000 for the Q1 of 2023 compared to $2,900,000 for the Q1 of 2022. Speaker 500:15:17The increase in selling, general and administrative expenses for the quarter ending March 31, 2023 was primarily due to an increase in employee related costs, commercial costs and legal and professional service costs. We reported a net loss of $11,200,000 Speaker 400:15:35for the Speaker 500:15:35Q1 of 2023 compared to a net loss of $7,700,000 for the comparable period in 2022. As of March 31, 2023, we held $116,100,000 in cash, cash equivalents and short term investments compared to $118,400,000 as of December 31, 2022. As of March 31, 2023, SC Pharmaceuticals total shares outstanding was 35,000,000 769,073 shares. That concludes the financial update. John? Speaker 200:16:19Thanks, Rachel. This concludes our prepared remarks. At this point, we will open the call for questions. Operator00:16:27Thank you, sir. We will now be conducting a question and answer session. The first question we have is from Glenn Santangelo from Jefferies. Please go ahead. Speaker 600:17:00Yes, good evening. Thanks for taking my question. Glad to see the launch is off to a great start, so congrats on that. John, I don't know if this question is for you or for Steve, but I did want to follow-up on some of the KPIs You gave particularly around the 381 scripts that were written versus the 161 that were filled. I think Steve, I heard you say that that's due to a combination of things like the patient being unreachable or hospitalized or Unfortunately, deceased, but some of them I think you suggested might have been reimbursement related around co pays. Speaker 600:17:36So I was wondering if you could just flesh that out a little bit more. And I think you said you expect that this sort of narrow, any sort of color around that you can give us would be helpful. Thanks. Speaker 200:17:47Hey, Glenn, this is John. Thanks for the question. I'll let Steve answer that. Steve? Speaker 400:17:52Yes. It's just multiple factors that contribute to the fill And the timing at which that happens. As I alluded, it depends on the prescriber, some on the payer and the patient. It's early. We got to get the HCPs, the healthcare providers in the habit of providing everything that the payer needs upfront So that they can process the prescription quickly. Speaker 400:18:17They have everything that the payer needs. When they forget to include something, it might slow down the process Until the hub can reach them, some are sending in prescriptions for what we call pre approval. They don't need it immediately. The patient doesn't need it immediately. It's in case they need urostics in the future. Speaker 400:18:39So there's some of that that's in the pending, as I said. And in that case, it's less urgency for adjudication. There's some patients who resolve. They order for HERO6 just in case and then using standard of care, The patient results, which is a good thing for the patient. We do still have some plans where the co pays are too high and we're actively working to address that. Speaker 400:19:06We think the addition of this one top five health plan coming online June 1 could really help us there. Speaker 600:19:15Perfect. Thanks for the details. Speaker 700:19:17Yes, it does. Thanks, Vadci. Maybe I Speaker 600:19:19can just follow-up on one more here. I want to ask about the in services completed to date. I think you said 743 as of April 28. And John, I thought I might have heard quoted at a conference somewhere saying that you'd expect to have the bulk of the in services done by the middle of the second quarter. I may be mistaken, but I don't know if that's still your goal. Speaker 600:19:42And I'm just trying to reconcile that versus now you have 44 sales reps, Mike, when do you think you'll be through the bulk of the in services with sort of your target audience and we can think about maybe what that's Going to mean from an expense trajectory perspective and maybe how scripts will ramp over the balance of the year once that's completed? Thanks. Speaker 200:20:06Yes, so good morning, it's John. So with the 743 complete, we still have a number booked moving forward, both in new territories And some existing territories. It's important to note that in some places, 1 in service isn't enough. They might have all kinds of satellite locations. They might want us to come back to see a different part of their staff. Speaker 200:20:34So, I think we'll have the bulk of them done here in the next month or so. But I we want to be doing in services now. We don't want to be doing just in services forever because it slows down your call average a little bit. But we think we'll still be doing them at least through the end of this quarter, probably in the 3rd. But I think the bulk of them will be done You know, big bulk can be done by the end of this quarter. Speaker 600:21:05Okay. Thanks for the comments. Speaker 400:21:08Thanks, Glenn. Operator00:21:11The next question we have is from Ioana Ruiz from SVB Securities. Please go ahead. Speaker 800:21:19Hey, afternoon, everyone, and congrats on the progress so far. A few from me. I wanted to ask about The range of doses seen for PHYOXIX, I think you mentioned 2 to 12. So I was curious what's Driving the high end of that range, where physician what are physicians saying basically to justify those more doses for which patients basically? Speaker 200:21:44Yes. Steve, do you want to? Speaker 400:21:46Yes. We always will see you'll hear this a lot. It's really early On drawing any conclusions on what those doses will moderate to, we still think our guidance of around 4 We'll be where we end up. It's a little higher than that right now, we admit. The 12 versus the 2, the 2 is really Someone just tip it, putting their toe in the pool. Speaker 400:22:11They're not quite sure how it's going to work yet. And so they just want to see, they want to try And then they'll order a couple more. The 12 is, it's more severe patients, people who have an awful lot of fluid. They want to really sometimes they'll use 2 a day to try to address that fluid. These are people Are pretty close to go into the ER, the hospital and they don't need to, but they're closed if they don't get an intervention. Speaker 400:22:38So Those are the extremes. I think we just wanted to give you color on how big or small they get, but we think that it will moderate around 4. Speaker 800:22:50Okay, great. And thinking about the total Pharosix prescriptions written, I was curious if you could give us some detail around if any of them are pre admission versus post discharge and just trying to understand the dynamics there. I know it's pretty early, but if you're seeing any themes, that would be super interesting. Speaker 200:23:09Steve, I'll add a comment, but why don't you go ahead. Speaker 400:23:13Yes. We don't capture that information In our Rx start forms or anywhere in our hub data, anecdotally, we feel like more Rxs are happening pre admission And then post discharge at this early stage, there's a lot more patients who are in the pre admission setting with fluid issues Then there are post discharge, which is really just a 30 day period. So, that makes sense. And again, it's early in the launch. We don't know the split, but I would say anecdotally, It's more on the front end before they get hospitalized. Speaker 200:23:50And I think, Ron, this is John. And by the way, thanks for joining the call. I also think that anecdotally what we're hearing on these pre admissions might be Part of the reason why we're seeing a little higher average number of units per script, because I think if you think about it, A patient that's being discharged was discharged and is coming back in 5 days after the discharge Has been diaries actively IV diaries for 4 or 5 days. So you would think they would need less. So I think that the higher Script count or the higher doses per script might also kind of hear all of what we're hearing anecdotally that it's more pre admission right now. Speaker 800:24:39Interesting. Super helpful. And last one for me. I was curious, what are you seeing in the regional Trends, any sort of like fast growing areas that you're noticing so far? Speaker 200:24:53Steve, do you want to? Speaker 400:24:55I don't think it's regional. I couldn't say it's that way. We have Territories that are doing better and the rep, it's really rep driven where people are ahead of others, Ahead of the average, ahead of the norm, but it's not regional. It's not that's and we have territories in every region of the country, even with just your reps, we cover the nation except for the big center. So I don't have regional observations, just individual rep Speaker 200:25:28It's a little early. John, I think you had one observation though. Speaker 300:25:31I think, Roan, you had asked about the number of doses. And I think that it's we have had we had doctors That participated in both the Freedom and the At Home study as well that have had a bit experience. And so they have with them with a little bit more experience, have a little bit more Comfort and are you the ones that are probably using some of the higher doses. So that has had an impact on that as well. Speaker 400:25:59And I think the other Speaker 200:26:00thing we've seen, which I think is encouraging is that the doctors that did participate In Freedom and At Home have been early writers of the product, which hopefully they've had Experian and they did well on this study and can embrace it as it gets into the market. But it's really early, but we have seen some of those doctors writing early. Speaker 800:26:28Got it. Great. Super helpful. Thanks. Speaker 200:26:30Thanks, Operator00:26:42The next question we have is from Stacy Ku from TD Cowen. Please go ahead. Speaker 900:26:48Thanks so much for taking our questions and congratulations on the progress. So first, as we think about the different centers and where you're seeing patients, it seems to be a lot of preadmissions. So Are you able to get a sense of which heart failure centers might not have easy access to IV theoretics? So maybe some more low hanging fruit, are you getting any feedback as you're kind of on boarding. So that's the first question. Speaker 900:27:15And then the second is just about the clinicians. Would they need to be more comfortable kind of using it post admission, what do they want to see to be able to use for 0.6 to shorten hospital stays, what practice would need to be adjusted from their end? Any feedback that they're providing would also be really helpful. And then last, can you just clarify, Is this a single co pay for this range of doses? Thank you. Speaker 200:27:44I think those are all Yes, Steve showed today. So Speaker 400:27:48I think the first one is around any differentiation between places that have access to IV diuretics versus places that don't, does that affect the adoption rate? I think it does. I think it does. Did I get that question right? Yes, Speaker 900:28:03absolutely. Yes. Speaker 400:28:04Are you Speaker 900:28:04seeing any kind of tenders that don't have high b theoretics and Maybe that's why that you're seeing kind of this really high, high range of business? Speaker 400:28:15Yes. Well, There are certainly quicker adopters if they don't have IV access for sure. There's a much greater unmet need for them than some other places. And I think it's probably true. If they do have access to IV, they might treat them diaries in the office And then finish the job with Euro 6 at home and maybe they don't need as many doses if they've done a day in the office. Speaker 400:28:43They normally 4 days or 5 days and It'd be one less, right? So I think that's rational. You asked about comfort in the discharge setting. I don't think that's an issue. I think people are comfortable using it there. Speaker 400:28:57We don't want to say that there's none happening there. I think people ask me to characterize What the mix is, it is a little higher in the pre admission. There's just not as many patients who are Fluid overloaded after they've been discharged from the hospital. There's about 20% to 25% who get in trouble in the next 30 days. And so I think those will be our patients, but you just look at the raw numbers, there's more patients who are Pre admission. Speaker 200:29:30Stacy, it's John. And I think we think about the different use cases pre admission, Post discharge, even reduction of length of stay, it's the same patient. It's the same treating doc. It's kind of Where they are in their in the journey. But we do think once physicians get more and more comfortable using it, and I think One thing we're hearing anecdotally is that patients are doing well on PROSIS is working as advertised, which Kind of is a key thing here. Speaker 200:30:03Once doctors are more and more comfortable using it, even if they start with just their pre admission We think then they'd expand that usage if appropriate for a potential early discharge And then for that to keep that patient from bouncing back in the hospital. We think that's why the in services are important. That's why Positive use is important. I think the other question, I think John did you have something to add? Speaker 300:30:33I think around Stacy, John Moore on the IV I think it's important just to point out that there's only while you it makes sense that these things should be very, very common because they make Sense to have the ability to give IV diuretics. It's just not commonly used and we've sort of estimated that about 20% of Institutions have the availability to administer IV directs in the outpatient setting because it's just it's logistically challenging to be able to do that. On the flip side, those that do it have demonstrated comfort with the ability to give IV diuretics in that setting and have and it kind of makes sense for them to be some of the early Speaker 200:31:14And your third question, Stacy, on the co pays, what we've seen is That it doesn't matter if the dose is 2 or 12, it's a single co pay for the patient. Speaker 900:31:26Okay. That's incredibly helpful. Thank you for all the details. Speaker 200:31:30Thanks, Stacy. Operator00:31:34The next question we have is from Douglas Tsao from H. C. Wainwright. Please go ahead. Speaker 700:31:41Hi. Thanks for taking the questions. Maybe to start, John, in terms of How quick is it taking from a position to participating in an in service To actually starting to write, or are they needing sort of a follow-up call from a sales rep? And then just in terms of the physicians that participated in the FREEDOM and at home studies, are they using the product in a different way than other people who are writing For 406. Thank you. Speaker 200:32:19Hey, Doug, it's John. Thanks for the question. So I'll probably have Steve and John Chime in. I think it depends on the in service. I think we did see early on, I think we talked On the last call, kind of a queue of patients that some doctors did have, not all doctors clearly, but some. Speaker 200:32:40And they were already had a patient in their mind or and so we in service them, they asked for the in service, they outreach to us They're at a conference or over the phone. And so they were very quick to activate after an in service. Other physicians, it does take the in service and then a call and then maybe another call. It's the same thing. It's The difference between getting the one script, which is maybe right after an in service, what you want to do is change long term behavior and that's going to take a number of But it just depends on it. Speaker 200:33:17Again, the docs that had a patient in the queue, as soon as we activated them, They were writing scripts. And some of them, it's taken a little bit longer to get a patient. And the other question, John? Doug, John Moore. Speaker 300:33:34Are the individuals that participate in the study using PHAR-six differently than other Clinicians. And I don't think that that's true. I think that the criteria used for the study on inclusion criteria and exclusion criteria were very, very clinically oriented. The way that they're evaluated in the clinic today and I would say and it was they were very that when they were controlled, they were very pragmatic and real world. So I would say that they're probably using it the same way as others. Speaker 300:33:59I think the comment was is that, even in some of those studies, They were using a little bit more doses because of the types of patients that they were enrolling in the study. And that was just the total number of doses I think would be different. The way in which they're using it, I say it very, very, very similar. Speaker 400:34:16Yes. They have confidence. Some of them are speakers for us, right? So we're doing peer to peer programs and it's very helpful for them to talk to their peer physicians, their peer nurse practitioners and PAs As Dave questions about, well, what about higher BMI patients? What about lower BMI patients? Speaker 400:34:38What about elderly patients, 80 year olds? And they're able to speak to I've used it in all of these patients and there's no restrictions in my mind on who you can use it with. So that takes Potential reservation and reluctance because it's unknown to the new prescriber off the table when they hear about the broad use. So we'll continue to do speaker programs peer to peer, virtual and we're starting to ramp up face to face. Speaker 700:35:08Great. Thank you. Speaker 200:35:10Thanks, Operator00:35:21The next question we have is from Raul Nahraman from Maxim Group. Please go ahead. Speaker 1000:35:28Hi, everyone. Thanks for taking my questions and congrats on the initial launch metrics. Just a few. The first question I had Is in regards to prior auths, do you could you provide us some color on, I guess, like the rate of prior auth that are approved like on the first pass? My second question is, on the pharma division by the top 5 national health plan, Could you give us some color on how many cover lives that plan covers, how many cover lives that adds? Speaker 1000:36:01And my third question is, I guess based on the initial feedback and perception that hospitals and physician Have you seen any request to potentially purchase bulk orders of Pharosys by said practices? Speaker 400:36:22So let me try Speaker 200:36:24to take the last 2 and then maybe turn it over to Steve for the first one. So the bulk purchases by offices probably doesn't make sense, it's not a Part B, it's not Bye, Bill. But I would think in the future that there will be direct purchases From systems that have they might have infusion clinics, they might have Pharmacies, they might have an outpatient pharmacy in the hospital just to make sure patients have pretty quick access. So That's I think that's what we see. What was the second question? Speaker 200:37:10I tried to write it down. Speaker 400:37:11How many lives in this top 5 TAMs? The problem is Speaker 200:37:15that, we'd love to tell you what who it is. Speaker 400:37:18June 1st, we can tell you. Speaker 200:37:19June 1st, we can tell you. It's You'll know the name well. Maybe I leave it there, but we're really happy. We've it's the commercial plan. We've had negotiations now, negotiations on their Part D with them now as well. Speaker 200:37:42So we're really not allowed to use their name. It's over 25,000,000. 25,000,000 lives covered on the commercial side of the business. So it's one of the big guys. Speaker 400:37:54And then the last one, I think was the PA timing, how long that takes? Speaker 200:37:59What's required. Speaker 400:38:00What's that? Speaker 200:38:01What's required in the PA. Speaker 400:38:02What's required in the PA? Speaker 1000:38:05Like how many of those what percentage of those PA go through like the first pass? Speaker 400:38:13Good question. I actually don't know that data precisely. It's more than not. 1st pass, yes, I mean, if the doctor sends in the information that's required and they're getting better at that, It should be around 80%, 75%, 80%. Speaker 200:38:38Now keep in mind though, just that 75%, 80%, They still could the prior auth could be approved, they still could have a very high co pay. So, a PA getting approved obviously is huge, but if The patient still has a percent co insurance then that's an obstacle. Speaker 400:38:58So Yes. I think we've said, The patient has to be Class II or Class III. So there's some Class IVs that have come through that Not indicated for at the moment. So there's a little bit of that factor in. So if they provide the right information, they go through and Medicare has got rules about how quickly they have to be done. Speaker 1000:39:28Got it. Thanks for taking the answer my questions and congrats on the initial launch. Speaker 200:39:33Thanks. Thank you, Nezh. Operator00:39:38There are no further questions at this time. I would like to turn the floor back over to John Tucker for closing comments. Please go ahead, sir. Speaker 200:39:48Okay. That concludes our call this afternoon. We hope you take away from this call that we are pleased with our progress to date. And as we continue to execute on our commercial plan, We anticipate continued growth in the percentage of heart failure patients with affordable access to Pharosix, which we believe will translate into a nice trajectory for both prescriptions and revenue. We look forward to providing more information during our Q2 update in August. Speaker 200:40:13Thank you again and have a good evening. Operator00:40:19Thank you, sir. Ladies and gentlemen, that then concludes today's conference. Thank you for joining us. You may now disconnect yourRead morePowered by Conference Call Audio Live Call not available Earnings Conference CallscPharmaceuticals Q1 202300:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) scPharmaceuticals Earnings HeadlinesscPharmaceuticals Announces Participation in Three Upcoming Investor ConferencesMay 1, 2025 | globenewswire.comHead-To-Head Comparison: scPharmaceuticals (NASDAQ:SCPH) versus Purple Biotech (NASDAQ:PPBT)April 27, 2025 | americanbankingnews.comHere’s How to Claim Your Stake in Elon’s Private Company, xAII predict this single breakthrough could make Elon the world’s first trillionaire — and mint more new millionaires than any tech advance in history. And for a limited time, you have the chance to claim a stake in this project, even though it’s housed inside Elon’s private company, xAI.May 5, 2025 | Brownstone Research (Ad)scPharmaceuticals Stock Price, Quotes and ForecastsApril 25, 2025 | benzinga.comAnalysts Are Bullish on These Healthcare Stocks: scPharmaceuticals (SCPH), Sarepta Therapeutics (SRPT)April 23, 2025 | markets.businessinsider.comCraig-Hallum Sticks to Its Buy Rating for scPharmaceuticals (SCPH)March 22, 2025 | markets.businessinsider.comSee More scPharmaceuticals Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like scPharmaceuticals? Sign up for Earnings360's daily newsletter to receive timely earnings updates on scPharmaceuticals and other key companies, straight to your email. Email Address About scPharmaceuticalsscPharmaceuticals (NASDAQ:SCPH), a pharmaceutical company, engages in the development and commercialization of various pharmaceutical products. Its lead product candidate is FUROSCIX that consists of formulation of furosemide, which is delivered through an on-body infusor for treatment of congestion due to fluid overload in adults with chronic heart failure and kidney disease, as well as consists of subcutaneous loop diuretic that delivers IV equivalent diuresis at home; and FUROSCIX On-Body Infusor, a drug-device combination product consisting of FUROSCIX. The company's product pipeline also includes SCP-111 (furosemide injection), an investigational pH neutral aqueous furosemide formulation that is being developed for subcutaneous administration outside of the hospital setting, including patient self-administration in the home; and SCP-111 Autoinjector, an investigational single-entity, drug-device combination product candidate consisting of a prefilled syringe containing SCP-111, preloaded into a commercially available, fixed single dose, disposable, two step mechanical autoinjector. It has a collaboration agreement with West Pharmaceutical Services, Inc. The company was incorporated in 2013 and is headquartered in Burlington, Massachusetts.View scPharmaceuticals ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Is Reddit Stock a Buy, Sell, or Hold After Earnings Release?Warning or Opportunity After Super Micro Computer's EarningsAmazon Earnings: 2 Reasons to Love It, 1 Reason to Be CautiousRocket Lab Braces for Q1 Earnings Amid Soaring ExpectationsMeta Takes A Bow With Q1 Earnings - Watch For Tariff Impact in Q2Palantir Earnings: 1 Bullish Signal and 1 Area of ConcernVisa Q2 Earnings Top Forecasts, Adds $30B Buyback Plan Upcoming Earnings Advanced Micro Devices (5/6/2025)American Electric Power (5/6/2025)Constellation Energy (5/6/2025)Marriott International (5/6/2025)Energy Transfer (5/6/2025)Mplx (5/6/2025)Brookfield Asset Management (5/6/2025)Arista Networks (5/6/2025)Duke Energy (5/6/2025)Zoetis (5/6/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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There are 11 speakers on the call. Operator00:00:00Greetings, and welcome to the SC Pharmaceuticals First Quarter 2023 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. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, P. Operator00:00:30J. Kelleher from LifeSci Advisors. Thank you. Please go ahead, sir. Speaker 100:00:35Thank you, operator. 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 within the meaning of the federal securities laws, Including, but not limited to, statements regarding SC Pharmaceuticals' expected future financial results and management's expectations and plans for the business in Ferosix. The words anticipate, believe, estimate, expect, intend, guidance, confidence, Target, project and other similar expressions are used typically to identify such forward looking statements. These forward looking statements are not guarantees of future performance and may involve and are subject to certain risks and uncertainties and other important factors that may affect SC Pharmaceuticals Business, Financial Condition and Other Operating Results. Speaker 100:01:31These quarterly reports on Form 10 Q and other reports filed by the company with the SEC to which your attention is directed. Actual outcomes and results may differ materially from what is expressed or implied by these forward looking statements. 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 It is now my pleasure to turn the call over to Mr. John Tucker, Chief Executive Officer of SC Pharmaceuticals. John? Speaker 200:02:20Thank you, PJ, and thanks to everyone listening to this afternoon's call and webcast. This afternoon, I'm pleased to provide an operational update before turning the call over to Steve Farsons, our Senior Vice President of Commercial, For a more detailed update on the early stages of the Ferosix launch and then Rachel Noakes, our Chief Financial Officer, for a review of our financials. We will then open the call up for your questions. Just two and a half months into the Pharosix launch on February 20th, We are pleased with our progress to date and early feedback suggests that Pharosix is being well received in the market. Notably, our commercial team continues to execute An important leading indicator in services with healthcare providers and have completed 518 through March 31st And have completed 743 total in services as of April 28. Speaker 200:03:13These initial in service contacts can last up to 2 hours As treating physicians often want the entire office to be educated and trained on the use of phorosis. As Steve will detail momentarily, These early efforts are working as intended as both unique prescribers and total prescriptions written are growing nicely. This supports our strong belief that Pharosix will quickly become a core part of the heart failure treatment paradigm, either pre hospital admission or post discharge as it allows patients for the very first time to receive IV equivalent furosemide based on similar systemic But by avoiding hospital admissions and readmissions, significant cost savings can accrue to commercial, Medicare Part D and Medicaid payers, as well as hospitals who face significant and worsening reimbursement pressure for their heart failure patients. As a reminder, PHAROSIX is indicated for the Pharosix is not indicated for use in emergency situations or in patients with acute pulmonary edema. The OnBody Infuser will deliver only an 80 milligram dose for Pharosix. Speaker 200:04:39Last quarter, we detailed 2 studies that we conducted that clearly demonstrate the potential financial benefits of Pharosix. One prospective FREEDOM HF focused on select patients who presented to the emergency room with a worsening heart failure event and were treated with furosics at home as opposed to being admitted to the hospital. The result of the study was that patients treated with Pharosix had heart failure related costs were lower by an average of $16,995 versus historically matched comparators. And this result was achieved with a very high rate of Since pricing had not been established at the time of the study, the conclusion remains unchanged. And the second study, The Phase 2 pilot study at home HF compared PHAROSIX with treatment as usual approach in chronic heart failure Presenting to a heart failure clinic that worsening congestion requiring augmented diuresis. Speaker 200:05:42Among the key findings, Subjects randomized to Pharosix had a 37% reduction in the risk of a heart failure hospitalization at day 30 relative to patients randomized to treatment as usual. The outcome of both studies provide a compelling picture of the benefits of Ferosix and further support the efforts of our commercial team as they work to educate treating physicians and their staff. They also provide critical as we engage with payer, pharmacy and therapeutic committees regarding reimbursement dynamics. On the topic of the payers, We continue to have productive discussions with commercial, Medicare Part D and Medicaid payers in a continuing effort to make Pharosix broadly available at the most favorable terms possible. This involves not only securing initial coverage of ferrosix, but also working to have a place on a formulary tier that would be affordable to most patients. Speaker 200:06:36We previously indicated that approximately 60% of all heart failure patients can access for our 6 under steer co pays of $100 or less, and we believe that over time we can increase this to 75% Speaker 300:06:48or more. Speaker 200:06:51Reflecting our continued progress, we were recently notified by a top 5 national health plan that Pharosix will be placed in a preferred formulary status across all of its commercial plans effective June 1. We regard this as a significant positive reimbursement development And we remain in discussions with this payer regarding its Part D plans with the goal of securing similarly favorable formulary placement for its Medicare beneficiaries. As mentioned, we are engaged with many other health plans and we hope to have several more announcements like this in the months to come. In addition, we are also recently informed that we will obtain national Medicaid coverage of Ferrosix effective July 1, 2023. The market opportunity for Pharosix is significant. Speaker 200:07:35We believe it is worth reiterating. In the U. S. Alone, there are estimated to be effectively addressed by Pharosix. If we assume $3,300 per episode, which is 4 doses of Pharosix, We have the potential to access a market opportunity that is nearly $7,000,000,000 And again, this is in the U. Speaker 200:08:02S. Alone. There were a total of 15,800,000 adults suffering from heart failure if we include the other G7 countries. At this early stage, we are seeing a wide range of doses up for O6 per prescription from 2 to 12 as this is at of the treating physician and some patients require more aggressive interventions than others. Finally, we are well funded with more than $116,000,000 Cash, cash equivalents and short term investments as of March 31, providing us with ample resources to continue to execute on our commercial plan. Speaker 200:08:36At this point, I'll turn the call over to our Senior Vice President of Commercial, Steve Parsons for a deeper dive into our early launch metrics. Steve? Speaker 400:08:45Thank you, John. As John indicated, well, it has only been about 2.5 months since we announced the launch and commercial availability At Purosix, on February 20, we are pleased with our initial progress. I'll start with an update on our commercial team. We currently have 41 field territory sales representatives with 3 additional reps expected to join by the end of May for a total of 44. They are conducting face to face in services at hospitals, doctors' offices and heart failure clinics. Speaker 400:09:19We stand ready to add more as demand patterns for pherosics continue to emerge. Targeting 150 to 200 healthcare providers and 12 hospitals per territory in services provide healthcare providers with training and prescribing instructions for Ferozix designed to ensure office readiness. Demo kits trained patients are provided at the completion of each in service. The focus on the in service is crucial to ensuring effective use and training on PureSec. As John mentioned, our sales force conducted 518 in services as of March 31st have completed 743 total in services as of April 28. Speaker 400:10:08Many of these in service are lasting 1 to 2 hours as physicians desire to have training done throughout the entire office or clinic. This reflects the interest in Pareosix by healthcare providers. This sales team is a specialized force that can target top clinics and doctors' offices efficiently and effectively. They are focused on building strong relationships with the key constituencies at these clinics through an educational and consultative approach. And while it is still early, we will be ready to add more reps in the field as needed to maximize the clinic and patient access to the ROCCs. Speaker 400:10:51The early results are encouraging. Through March 31, we had 194 total prescribers with a total of 381 prescriptions written and 161 prescriptions filled by the last day of the quarter. As of March 31, we had 152 prescriptions still pending. The vast majority of the balance of prescriptions pending are either due to prescriptions doctors have written that are queued and ready for patients or prescriptions still in progress with payers. We continue to move pending prescriptions into the filled bucket with each day. Speaker 400:11:33We have a small number of prescriptions abandoned And the reason for these cancellations are varied, ranging from patient being unreachable, hospitalized or deceased. There have also been a small number where the patient's co pay was a little too high. As we've already seen so far in April, We would anticipate that the difference between prescriptions written and filled will narrow as ferrosix is placed on more health plan formularies, expanding access for patients and lowering patients' out of pocket expense. At the moment, the average number of doses per prescription is slightly higher than 4, but we continue to believe 4 doses per prescription to be the right number long term. In terms of distribution, As we indicated last quarter, we are pleased with the functioning of our distribution process thus far through our strategic partnership with Cardinal Health as our 3rd party logistics provider. Speaker 400:12:41Cardinal is working well with our 3 specialty pharmacy partners, including our main specialty pharmacy, BioMatrix. Cardinal has shipped initial inventory to the specialty pharmacies, which is reflected in our Q1 revenue. As a reminder, we recognize revenue when furosix moves from Cardinal to the specialty pharmacies. Grosix direct, our reimbursement support hub, provides benefits investigations for physicians to determine insurance coverage and patient out of pocket costs. Our specialty pharmacy partners provide device training to patients and are available 24 hours a day to answer questions about the use of HERO6. Speaker 400:13:27From a marketing perspective, we are engaged in a broad omni channel market awareness campaign to drive brand awareness, adoption and commitment. 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 critical tasks. Overall, although we still have a lot of work to do, we are pleased with our early progress and the trajectory that we are on. That concludes my update. I would now like to turn the call over to our CFO, Rachel Noakes for a financial update. Speaker 400:14:13Rachel? Speaker 500:14:15Thank you, Steve. We generated net product revenue of $2,100,000 during the Q1 of 2023 and the cost of revenue was $600,000 yielding a gross profit of $1,500,000 One quick note for Q1, the cost of revenue excludes inventory that was expensed prior to FDA approval in October of 2022. Research and development expenses were $2,100,000 for the Q1 of 2023 compared to $4,300,000 for the comparable period in 2022. The decrease was primarily due to a decrease in clinical study and medical affairs costs, employee related costs, device and pharmaceutical development costs and quality and regulatory costs. Selling, general and administrative expenses were $10,900,000 for the Q1 of 2023 compared to $2,900,000 for the Q1 of 2022. Speaker 500:15:17The increase in selling, general and administrative expenses for the quarter ending March 31, 2023 was primarily due to an increase in employee related costs, commercial costs and legal and professional service costs. We reported a net loss of $11,200,000 Speaker 400:15:35for the Speaker 500:15:35Q1 of 2023 compared to a net loss of $7,700,000 for the comparable period in 2022. As of March 31, 2023, we held $116,100,000 in cash, cash equivalents and short term investments compared to $118,400,000 as of December 31, 2022. As of March 31, 2023, SC Pharmaceuticals total shares outstanding was 35,000,000 769,073 shares. That concludes the financial update. John? Speaker 200:16:19Thanks, Rachel. This concludes our prepared remarks. At this point, we will open the call for questions. Operator00:16:27Thank you, sir. We will now be conducting a question and answer session. The first question we have is from Glenn Santangelo from Jefferies. Please go ahead. Speaker 600:17:00Yes, good evening. Thanks for taking my question. Glad to see the launch is off to a great start, so congrats on that. John, I don't know if this question is for you or for Steve, but I did want to follow-up on some of the KPIs You gave particularly around the 381 scripts that were written versus the 161 that were filled. I think Steve, I heard you say that that's due to a combination of things like the patient being unreachable or hospitalized or Unfortunately, deceased, but some of them I think you suggested might have been reimbursement related around co pays. Speaker 600:17:36So I was wondering if you could just flesh that out a little bit more. And I think you said you expect that this sort of narrow, any sort of color around that you can give us would be helpful. Thanks. Speaker 200:17:47Hey, Glenn, this is John. Thanks for the question. I'll let Steve answer that. Steve? Speaker 400:17:52Yes. It's just multiple factors that contribute to the fill And the timing at which that happens. As I alluded, it depends on the prescriber, some on the payer and the patient. It's early. We got to get the HCPs, the healthcare providers in the habit of providing everything that the payer needs upfront So that they can process the prescription quickly. Speaker 400:18:17They have everything that the payer needs. When they forget to include something, it might slow down the process Until the hub can reach them, some are sending in prescriptions for what we call pre approval. They don't need it immediately. The patient doesn't need it immediately. It's in case they need urostics in the future. Speaker 400:18:39So there's some of that that's in the pending, as I said. And in that case, it's less urgency for adjudication. There's some patients who resolve. They order for HERO6 just in case and then using standard of care, The patient results, which is a good thing for the patient. We do still have some plans where the co pays are too high and we're actively working to address that. Speaker 400:19:06We think the addition of this one top five health plan coming online June 1 could really help us there. Speaker 600:19:15Perfect. Thanks for the details. Speaker 700:19:17Yes, it does. Thanks, Vadci. Maybe I Speaker 600:19:19can just follow-up on one more here. I want to ask about the in services completed to date. I think you said 743 as of April 28. And John, I thought I might have heard quoted at a conference somewhere saying that you'd expect to have the bulk of the in services done by the middle of the second quarter. I may be mistaken, but I don't know if that's still your goal. Speaker 600:19:42And I'm just trying to reconcile that versus now you have 44 sales reps, Mike, when do you think you'll be through the bulk of the in services with sort of your target audience and we can think about maybe what that's Going to mean from an expense trajectory perspective and maybe how scripts will ramp over the balance of the year once that's completed? Thanks. Speaker 200:20:06Yes, so good morning, it's John. So with the 743 complete, we still have a number booked moving forward, both in new territories And some existing territories. It's important to note that in some places, 1 in service isn't enough. They might have all kinds of satellite locations. They might want us to come back to see a different part of their staff. Speaker 200:20:34So, I think we'll have the bulk of them done here in the next month or so. But I we want to be doing in services now. We don't want to be doing just in services forever because it slows down your call average a little bit. But we think we'll still be doing them at least through the end of this quarter, probably in the 3rd. But I think the bulk of them will be done You know, big bulk can be done by the end of this quarter. Speaker 600:21:05Okay. Thanks for the comments. Speaker 400:21:08Thanks, Glenn. Operator00:21:11The next question we have is from Ioana Ruiz from SVB Securities. Please go ahead. Speaker 800:21:19Hey, afternoon, everyone, and congrats on the progress so far. A few from me. I wanted to ask about The range of doses seen for PHYOXIX, I think you mentioned 2 to 12. So I was curious what's Driving the high end of that range, where physician what are physicians saying basically to justify those more doses for which patients basically? Speaker 200:21:44Yes. Steve, do you want to? Speaker 400:21:46Yes. We always will see you'll hear this a lot. It's really early On drawing any conclusions on what those doses will moderate to, we still think our guidance of around 4 We'll be where we end up. It's a little higher than that right now, we admit. The 12 versus the 2, the 2 is really Someone just tip it, putting their toe in the pool. Speaker 400:22:11They're not quite sure how it's going to work yet. And so they just want to see, they want to try And then they'll order a couple more. The 12 is, it's more severe patients, people who have an awful lot of fluid. They want to really sometimes they'll use 2 a day to try to address that fluid. These are people Are pretty close to go into the ER, the hospital and they don't need to, but they're closed if they don't get an intervention. Speaker 400:22:38So Those are the extremes. I think we just wanted to give you color on how big or small they get, but we think that it will moderate around 4. Speaker 800:22:50Okay, great. And thinking about the total Pharosix prescriptions written, I was curious if you could give us some detail around if any of them are pre admission versus post discharge and just trying to understand the dynamics there. I know it's pretty early, but if you're seeing any themes, that would be super interesting. Speaker 200:23:09Steve, I'll add a comment, but why don't you go ahead. Speaker 400:23:13Yes. We don't capture that information In our Rx start forms or anywhere in our hub data, anecdotally, we feel like more Rxs are happening pre admission And then post discharge at this early stage, there's a lot more patients who are in the pre admission setting with fluid issues Then there are post discharge, which is really just a 30 day period. So, that makes sense. And again, it's early in the launch. We don't know the split, but I would say anecdotally, It's more on the front end before they get hospitalized. Speaker 200:23:50And I think, Ron, this is John. And by the way, thanks for joining the call. I also think that anecdotally what we're hearing on these pre admissions might be Part of the reason why we're seeing a little higher average number of units per script, because I think if you think about it, A patient that's being discharged was discharged and is coming back in 5 days after the discharge Has been diaries actively IV diaries for 4 or 5 days. So you would think they would need less. So I think that the higher Script count or the higher doses per script might also kind of hear all of what we're hearing anecdotally that it's more pre admission right now. Speaker 800:24:39Interesting. Super helpful. And last one for me. I was curious, what are you seeing in the regional Trends, any sort of like fast growing areas that you're noticing so far? Speaker 200:24:53Steve, do you want to? Speaker 400:24:55I don't think it's regional. I couldn't say it's that way. We have Territories that are doing better and the rep, it's really rep driven where people are ahead of others, Ahead of the average, ahead of the norm, but it's not regional. It's not that's and we have territories in every region of the country, even with just your reps, we cover the nation except for the big center. So I don't have regional observations, just individual rep Speaker 200:25:28It's a little early. John, I think you had one observation though. Speaker 300:25:31I think, Roan, you had asked about the number of doses. And I think that it's we have had we had doctors That participated in both the Freedom and the At Home study as well that have had a bit experience. And so they have with them with a little bit more experience, have a little bit more Comfort and are you the ones that are probably using some of the higher doses. So that has had an impact on that as well. Speaker 400:25:59And I think the other Speaker 200:26:00thing we've seen, which I think is encouraging is that the doctors that did participate In Freedom and At Home have been early writers of the product, which hopefully they've had Experian and they did well on this study and can embrace it as it gets into the market. But it's really early, but we have seen some of those doctors writing early. Speaker 800:26:28Got it. Great. Super helpful. Thanks. Speaker 200:26:30Thanks, Operator00:26:42The next question we have is from Stacy Ku from TD Cowen. Please go ahead. Speaker 900:26:48Thanks so much for taking our questions and congratulations on the progress. So first, as we think about the different centers and where you're seeing patients, it seems to be a lot of preadmissions. So Are you able to get a sense of which heart failure centers might not have easy access to IV theoretics? So maybe some more low hanging fruit, are you getting any feedback as you're kind of on boarding. So that's the first question. Speaker 900:27:15And then the second is just about the clinicians. Would they need to be more comfortable kind of using it post admission, what do they want to see to be able to use for 0.6 to shorten hospital stays, what practice would need to be adjusted from their end? Any feedback that they're providing would also be really helpful. And then last, can you just clarify, Is this a single co pay for this range of doses? Thank you. Speaker 200:27:44I think those are all Yes, Steve showed today. So Speaker 400:27:48I think the first one is around any differentiation between places that have access to IV diuretics versus places that don't, does that affect the adoption rate? I think it does. I think it does. Did I get that question right? Yes, Speaker 900:28:03absolutely. Yes. Speaker 400:28:04Are you Speaker 900:28:04seeing any kind of tenders that don't have high b theoretics and Maybe that's why that you're seeing kind of this really high, high range of business? Speaker 400:28:15Yes. Well, There are certainly quicker adopters if they don't have IV access for sure. There's a much greater unmet need for them than some other places. And I think it's probably true. If they do have access to IV, they might treat them diaries in the office And then finish the job with Euro 6 at home and maybe they don't need as many doses if they've done a day in the office. Speaker 400:28:43They normally 4 days or 5 days and It'd be one less, right? So I think that's rational. You asked about comfort in the discharge setting. I don't think that's an issue. I think people are comfortable using it there. Speaker 400:28:57We don't want to say that there's none happening there. I think people ask me to characterize What the mix is, it is a little higher in the pre admission. There's just not as many patients who are Fluid overloaded after they've been discharged from the hospital. There's about 20% to 25% who get in trouble in the next 30 days. And so I think those will be our patients, but you just look at the raw numbers, there's more patients who are Pre admission. Speaker 200:29:30Stacy, it's John. And I think we think about the different use cases pre admission, Post discharge, even reduction of length of stay, it's the same patient. It's the same treating doc. It's kind of Where they are in their in the journey. But we do think once physicians get more and more comfortable using it, and I think One thing we're hearing anecdotally is that patients are doing well on PROSIS is working as advertised, which Kind of is a key thing here. Speaker 200:30:03Once doctors are more and more comfortable using it, even if they start with just their pre admission We think then they'd expand that usage if appropriate for a potential early discharge And then for that to keep that patient from bouncing back in the hospital. We think that's why the in services are important. That's why Positive use is important. I think the other question, I think John did you have something to add? Speaker 300:30:33I think around Stacy, John Moore on the IV I think it's important just to point out that there's only while you it makes sense that these things should be very, very common because they make Sense to have the ability to give IV diuretics. It's just not commonly used and we've sort of estimated that about 20% of Institutions have the availability to administer IV directs in the outpatient setting because it's just it's logistically challenging to be able to do that. On the flip side, those that do it have demonstrated comfort with the ability to give IV diuretics in that setting and have and it kind of makes sense for them to be some of the early Speaker 200:31:14And your third question, Stacy, on the co pays, what we've seen is That it doesn't matter if the dose is 2 or 12, it's a single co pay for the patient. Speaker 900:31:26Okay. That's incredibly helpful. Thank you for all the details. Speaker 200:31:30Thanks, Stacy. Operator00:31:34The next question we have is from Douglas Tsao from H. C. Wainwright. Please go ahead. Speaker 700:31:41Hi. Thanks for taking the questions. Maybe to start, John, in terms of How quick is it taking from a position to participating in an in service To actually starting to write, or are they needing sort of a follow-up call from a sales rep? And then just in terms of the physicians that participated in the FREEDOM and at home studies, are they using the product in a different way than other people who are writing For 406. Thank you. Speaker 200:32:19Hey, Doug, it's John. Thanks for the question. So I'll probably have Steve and John Chime in. I think it depends on the in service. I think we did see early on, I think we talked On the last call, kind of a queue of patients that some doctors did have, not all doctors clearly, but some. Speaker 200:32:40And they were already had a patient in their mind or and so we in service them, they asked for the in service, they outreach to us They're at a conference or over the phone. And so they were very quick to activate after an in service. Other physicians, it does take the in service and then a call and then maybe another call. It's the same thing. It's The difference between getting the one script, which is maybe right after an in service, what you want to do is change long term behavior and that's going to take a number of But it just depends on it. Speaker 200:33:17Again, the docs that had a patient in the queue, as soon as we activated them, They were writing scripts. And some of them, it's taken a little bit longer to get a patient. And the other question, John? Doug, John Moore. Speaker 300:33:34Are the individuals that participate in the study using PHAR-six differently than other Clinicians. And I don't think that that's true. I think that the criteria used for the study on inclusion criteria and exclusion criteria were very, very clinically oriented. The way that they're evaluated in the clinic today and I would say and it was they were very that when they were controlled, they were very pragmatic and real world. So I would say that they're probably using it the same way as others. Speaker 300:33:59I think the comment was is that, even in some of those studies, They were using a little bit more doses because of the types of patients that they were enrolling in the study. And that was just the total number of doses I think would be different. The way in which they're using it, I say it very, very, very similar. Speaker 400:34:16Yes. They have confidence. Some of them are speakers for us, right? So we're doing peer to peer programs and it's very helpful for them to talk to their peer physicians, their peer nurse practitioners and PAs As Dave questions about, well, what about higher BMI patients? What about lower BMI patients? Speaker 400:34:38What about elderly patients, 80 year olds? And they're able to speak to I've used it in all of these patients and there's no restrictions in my mind on who you can use it with. So that takes Potential reservation and reluctance because it's unknown to the new prescriber off the table when they hear about the broad use. So we'll continue to do speaker programs peer to peer, virtual and we're starting to ramp up face to face. Speaker 700:35:08Great. Thank you. Speaker 200:35:10Thanks, Operator00:35:21The next question we have is from Raul Nahraman from Maxim Group. Please go ahead. Speaker 1000:35:28Hi, everyone. Thanks for taking my questions and congrats on the initial launch metrics. Just a few. The first question I had Is in regards to prior auths, do you could you provide us some color on, I guess, like the rate of prior auth that are approved like on the first pass? My second question is, on the pharma division by the top 5 national health plan, Could you give us some color on how many cover lives that plan covers, how many cover lives that adds? Speaker 1000:36:01And my third question is, I guess based on the initial feedback and perception that hospitals and physician Have you seen any request to potentially purchase bulk orders of Pharosys by said practices? Speaker 400:36:22So let me try Speaker 200:36:24to take the last 2 and then maybe turn it over to Steve for the first one. So the bulk purchases by offices probably doesn't make sense, it's not a Part B, it's not Bye, Bill. But I would think in the future that there will be direct purchases From systems that have they might have infusion clinics, they might have Pharmacies, they might have an outpatient pharmacy in the hospital just to make sure patients have pretty quick access. So That's I think that's what we see. What was the second question? Speaker 200:37:10I tried to write it down. Speaker 400:37:11How many lives in this top 5 TAMs? The problem is Speaker 200:37:15that, we'd love to tell you what who it is. Speaker 400:37:18June 1st, we can tell you. Speaker 200:37:19June 1st, we can tell you. It's You'll know the name well. Maybe I leave it there, but we're really happy. We've it's the commercial plan. We've had negotiations now, negotiations on their Part D with them now as well. Speaker 200:37:42So we're really not allowed to use their name. It's over 25,000,000. 25,000,000 lives covered on the commercial side of the business. So it's one of the big guys. Speaker 400:37:54And then the last one, I think was the PA timing, how long that takes? Speaker 200:37:59What's required. Speaker 400:38:00What's that? Speaker 200:38:01What's required in the PA. Speaker 400:38:02What's required in the PA? Speaker 1000:38:05Like how many of those what percentage of those PA go through like the first pass? Speaker 400:38:13Good question. I actually don't know that data precisely. It's more than not. 1st pass, yes, I mean, if the doctor sends in the information that's required and they're getting better at that, It should be around 80%, 75%, 80%. Speaker 200:38:38Now keep in mind though, just that 75%, 80%, They still could the prior auth could be approved, they still could have a very high co pay. So, a PA getting approved obviously is huge, but if The patient still has a percent co insurance then that's an obstacle. Speaker 400:38:58So Yes. I think we've said, The patient has to be Class II or Class III. So there's some Class IVs that have come through that Not indicated for at the moment. So there's a little bit of that factor in. So if they provide the right information, they go through and Medicare has got rules about how quickly they have to be done. Speaker 1000:39:28Got it. Thanks for taking the answer my questions and congrats on the initial launch. Speaker 200:39:33Thanks. Thank you, Nezh. Operator00:39:38There are no further questions at this time. I would like to turn the floor back over to John Tucker for closing comments. Please go ahead, sir. Speaker 200:39:48Okay. That concludes our call this afternoon. We hope you take away from this call that we are pleased with our progress to date. And as we continue to execute on our commercial plan, We anticipate continued growth in the percentage of heart failure patients with affordable access to Pharosix, which we believe will translate into a nice trajectory for both prescriptions and revenue. We look forward to providing more information during our Q2 update in August. Speaker 200:40:13Thank you again and have a good evening. Operator00:40:19Thank you, sir. Ladies and gentlemen, that then concludes today's conference. Thank you for joining us. You may now disconnect yourRead morePowered by