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spk10: 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 zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, PJ Kelleher, LifeSci Advisors. Thank you, Peter. PJ, you may begin.
spk04: Thank 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 with a meaning of the federal securities law, including, but not limited to, statements regarding SC Pharmaceuticals' expected future financial results and management's expectations and plans for the business and for OPEX. The words anticipate, believe, estimate, expect, intend, guidance, confidence, target, project, and other similar expressions are typically used 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 business, financial condition, and other operating results. These include, but are not limited to, the risk factors and other qualifications contained in SC Pharmaceutical's annual report on Form 10-K, 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 four 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 expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. It is now my pleasure to turn the call over to Mr. John Tucker, Chief Executive Officer of SC Pharmaceuticals. John?
spk06: Thank you, PJ, and thank you to everyone listening to this afternoon's call and webcast. This afternoon, I am pleased to provide an operational update on the initial stages of the pro 6 commercial launch. Before I turn the call over to Rachel notes, our newly appointed chief financial officer. For review of our financials, well, it's only been a few weeks since we announced the launch and commercial availability of for a 6 on February 20th. Initial interest among patients providers and payers is very high. reflecting the important role that furosix can play in the heart failure treatment paradigm, either pre-hospital admission or post-discharge. As we have said before, we believe furosix 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 homes. Our own proprietary research suggests that among heart failure specialists, cardiologists, and nurse practitioners, intent to prescribe cirrhosis ranges between 93 and 96%. And intent to prescribe within six months ranges between 86 and 89%. This research underscores the openness to a different approach to the treatment of heart failure. 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 furosics to the many heart failure patients who stand to benefit from it. Taking a step back, or for the benefit of those maybe new to the story, in October of 2022, we received FDA approval for furosics a proprietary formulation of furosemide delivered by an on-body infuser, the outpatient treatment of congestion due to fluid overload in adult patients with New York Heart Association Class 2 and Class 3 chronic heart failure. Furosix is not indicated for use in emergency situations or in patients with acute pulmonary edema. The furosix infuser 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, who represent Medicare, the single largest payer for heart failure-related medical services. Pelosamide is the most widely used oral and parental diuretic available for patients with congestive heart failure. But the bioavailability of all furosemide decreases and becomes highly variable during episodes of worsening symptoms. As symptoms worsen, patients are often hospitalized to be treated with IV furosemide. By contract, furosix allows patients to access IV equivalent furosemide based on similar systemic exposure and diuresis in the comfort of their own homes. Furosix is administered subcutaneously with the West Pharmaceutical Services smart dose on-body drug delivery system technology, delivering an 80-milligram dose over a period of five hours. Heart failure is a significant financial pain point for both healthcare payers and hospitals. It's 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 may be potentially avoided. 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 and Part B spending. It's staggering, $123 billion. Further, hospitals face significant reimbursement pressure under the current heart failure payment structure. The average length of stay for heart failure patients is 5.2 days, while CMS reimburses just 3.9 days under the current DRG. Hospitals also face exposure to financial penalties resulting from readmissions under the hospital readmission reduction program, which includes heart failure as one of its focus conditions. Our clinical development program is focused on the safety and efficacy of furosics, as well as the pharmacoeconomic benefits to the system, a prospective clinical trial, FREEDOM-HF, without positive results in July of 2021. The study design 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 results of the study were patients treated with cirrhosis at heart failure-related costs that were lower by an average of $16,995 versus historically matched comparators. And this result was achieved with a very high rate of statistical significance with a p-value less 0.0001. While this analysis excludes the cost of furosics, since pricing had not been established at the time of the study readout, the conclusion remains unchanged. More recently, we announced positive results from a Phase II pilot study at home HF that compared furosics with a treatment-as-usual approach in chronic heart failure patients presenting to a heart failure clinic with worsening congestion requiring augmented diuresis. Among the key findings, subjects randomized to furosics had a 37% reduction in the risk of a heart failure hospitalization at day 30 relative to patients randomized to treatment as usual. We are pleased with the results of these two studies, which added significantly to the growing body of clinical and pharmacoeconomic evidence favoring furosics versus the current standard treatment protocol. The market opportunity for furosics is significant. In the U.S. alone, there are estimated to be 6.7 million adults suffering from heart failure, resulting in 4 million heart failure events annually. Of those, we believe 2.1 million episodes can be effectively addressed by furosics. If we assume $3,300 per episode, which is four doses of furosics, we have the potential to access a market opportunity that is nearly $7 billion. And again, this is in the U.S. alone. There are a total of 15.8 million adults suffering from heart failure if we include the other G7 countries. Coming now to the launch, we put a strong commercial team in place that is led by Steve Parsons, our Senior Vice President of Commercial. We have 40 field territory sales representatives fully trained in conducting face-to-face in-services at hospitals, doctor's offices, and heart failure clinics. Targeting the approximately 150 to 200 HCPs in 10 hospitals per territory, insurfaces provide HCPs with training and prescribing instructions for furosics designed to ensure office readiness. Demo kits to train patients are provided at the completion of each insurface. The focus on the insurface is crucial to ensuring effective use and training on furosics. 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. This reflects the interest in Ferocix 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. Depending on the launch trajectory, we stand ready to add more reps in the field as needed to maximize clinic and patient access to furosics. 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. Cardinal is working well with our three specialty pharmacy partners, including our main specialty pharmacy, Biomatrix. 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. So, Q1 revenue will reflect initial stocking at the specialty pharmacies. We have already seen initial patient prescriptions being filled and shipped to patients next day. Ferosix 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 with patients and are available 24 hours to answer questions about the use of Ferosix. From a marketing perspective, we've engaged in a broad, multi-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. In terms of reimbursement, we are pleased that all Medicare Part D and Medicaid beneficiaries will have reimbursed access to Ferocix since day one of the launch. We estimate that approximately 60% of all heart failure patients will have fixed tier copays of $100 or less. We continue to meet with many large national and regional Medicare Part D and commercial health plans, and those discussions have been productive. Our goal remains to achieve 75% of patients with access to Pro6 under fixed-tier copays by the end of this year. Turning to our balance sheet, in November, we were able to add $50 million of gross proceeds through a public offering of common stock. This follows a $100 million secured debt facility that we announced with Oak Tree Capital Management in October, $50 million of which was made available to us upon the signing of the agreement. The remaining $50 million will be made available in two additional $25 million tranches based on the achievement of pre-specified commercial milestones. With these financings, we believe we are well-funded to execute a very successful launch. Finally, in December, we announced the promotion of Rachel Noakes to the position of Chief Financial Officer. Rachel brings tremendous experience and leadership to the CFO role, and her promotion maintains organizational consistency and an important time for the company. We are excited to celebrate this well-deserved recognition of her expertise and contributions. I will now turn it over for her comments. Rachel?
spk01: Thank you, John. As of December 31st, 2022, we held $118.4 million in cash, cash equivalents, restricted cash, and investments. Our year-end cash includes net proceeds from the successful $50 million equity offering that we completed in November, plus the first $50 million 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. 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 compared to a net loss of $28 million for the full year 2021. The reported full year net loss was favorable for our guidance range of a full year net loss of 38 to $41 million. Research and development expenses were $2.3 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. For the full year 2022, we reported research and development expenses of $15.5 million compared to $16 million for the full year 2021. General and administrative expenses were $7.2 million for the fourth quarter of 2022 compared to $2.2 million for the comparable period in 2021. The increase was primarily due to an increase in employee-related costs, commercial preparations, and legal costs. 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. Based on our current operating plan, we expect our operating costs to increase in 2023 as we support the launch of Furosix, including investments in marketing and a field sales force. As of December 31, 2022, we had 34,257,916 total shares outstanding. That concludes the financial update. John?
spk06: Thanks, Rachel. This concludes our prepared remarks. At this point, we will open the call for questions.
spk10: 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. You may press star two 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.
spk02: Thank you.
spk10: Our first question is from Glenn Santangelo with Jefferies. Please proceed with your question.
spk07: Oh, yeah. Thanks for taking my question. Hey, John, I just want to follow up on some of the comments that you made when you were prepared to march. I think you were sort of talking about your interactions you're having with the various Part D plans. And if I heard you correctly, I thought you said that you hope by the end of this year you hope to have maybe 75% of the patients under contract with a 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 it all in perspective. Thanks.
spk06: Yeah. Hey, Glenn, thanks for the question. This is John, and I can have Steve 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, and commercial, and then we also have Medicaid. 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 plan that might have put us in the specialty tier, but our team has been really successful in keeping 406 out of the specialty tier in both commercial and Medicare Part D plans. As you know, specialty tier incorporates coinsurance, which is what we want to stay away from. So we've been successful with keeping it out of specialty tier. We've also gone through the P&T at all, but But one of the major plans, and have had successful P&T meetings at all, and we're still awaiting one plan to have that P&T. We're still in active negotiations around rebates. The good thing is with the Advantage, with Advantage Medicare Advantage, Patients will have fixed-tier copays of under $100. So we're still negotiating on moving those copays down. Our goal is a significantly lower copay than $100, and we'll rebate to get there, Glenn. We're not going to You know, we know the most important thing is patient affordability. So we'll be rebating with the plans, and we're negotiating with them now to lower the copay and to add to that 60% that has copays under 100 and try to actually get that up even higher than 75%. That includes the commercial plans as well. And, you know, we can't say a name, but we've had it. A recent big win there where a preferred formulary status, which would bring co-pays 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.
spk08: No, I think it's accurate. You know, 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 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 $10. whether they get three doses, four doses, five doses, six doses, it's the same copay. So we use 100 to be, you know, as the high water on about 60% of the patients. There's still some others that we are pursuing in an improved copay situation, but it's a really good place to start.
spk06: And we've seen, Glenn, we've seen scripts come in for commercial Medicaid and for Medicare Part D. And we filled all of those scripts for all three of those major payers in the market.
spk07: All right. Well, I appreciate all that detail. Thanks. Maybe I could just ask Rachel a quick follow-up question. I mean, in the prepared remarks, you 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 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 pharmacy stocking. And then you plan to make some additional investments in marketing and the sales force. And 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 build throughout the year? Any sort of color you can give us would be helpful. Thanks.
spk01: Hi, Glenn. This is Rachel. I'll speak to the costs first. So what we were saying is that we expect that the Q1 or 2023 expenses to be higher, to continue to increase from 2022 because we are putting that, you know, we now have the full commercial infrastructure, so the full 40-person sales force, as well as we continue to invest in marketing as well. So that was really a reflection of what to expect in 2023 versus 2022. And then regarding the revenue, John, I don't know if you want to talk about that. Sure.
spk06: Let me finish with the expenses. You know, so, Leonard, your question is, is it going to be linear from here? You know, the REF started the end of January, so Q1 on the expense side is probably going to be lighter. And we do anticipate adding reps, you know, later in the year. We haven't given 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 of January. But it should be pretty flat except for the addition of sales reps. potentially as early as Q2. As far as revenue, 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, it'll be predominantly that stocking inventory. We haven't given guidance, but I wouldn't think that stocking inventory would preclude you know, revenue in Q2, Q3, Q4, all of that. It's just initial stocking inventory to make sure that, you know, the product's there on the shelf when a physician puts a script in. So I hope that answers your question.
spk02: Yep, that's good. Thanks, Nicola.
spk10: Thank you. Our next question is from Nick Gassick with SVB Securities. Please proceed with your question.
spk09: 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 Furo6, 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?
spk06: Sure, Nick. This is John, and I'll talk a couple, and maybe, Steve, you can you can add to it. You know, some of the key things we'll start communicating, you know, as early as the May Q1 earnings call would be kind of number of new prescribers that are that are used for O6 average length of script, which is a big thing for us. As I think we've said, we anticipate three to four, so we'll be able to report on that. It'll still be early data, but it'll give us some directional things. Steve, what other things are you thinking of communicating quarterly?
spk08: 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 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 arises as we have more information. And of course, That sales. Yep.
spk06: 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, we're, we're anticipating, you know, we're, we're three weeks in data. I think we, we want to understand what the most, um, What's the most beneficial things to communicate to the street? And those are the things I think you'll learn. Those are the things we're planning on now. I think they could change in two 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.
spk09: That's very helpful. I also had a quick follow-up as well. I was wondering if you could give us 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? Please.
spk08: Yeah, so we're doing the traditional things, you know, digital advertisements in the key targeted journals, journals associated with Heart Failure Society of America, Heart Failure Nurses, had launched the American College of Cardiology, sent out an email blast announcing furosics 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 ads, banner ads, announcing our campaign, announcing the availability of furosics. So it's what Big Pharma does. omnichannel marketing like others do, just very, very targeted towards the folks that we are going after in the early launch period.
spk06: And if we were, as you know, we ran a pre-launch brand awareness campaign and actually were able to measure that prior to launch and were really impressed 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 happy with the interest we've seen in the field. We've had phone calls into various people in the office asking if they could talk to a rep. We've had a number of inquiries on the website. 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 exactly who to use furosics on and how to use it. So we're teaching the doctor, teaching the staff on how furosics works, how to use it, and as importantly, how to show patients. We want the offices interacting with those patients and training them, but we're also supporting the patients with 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 staffs 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, WashU. I mean, just, you know, exactly where we want to be. So we're really enthused with the awareness of the product when we launch and then the enthusiasm to talk to us when we're out there.
spk09: Very helpful. Thanks for all the updates. Aloha back to McHugh.
spk10: Thank you. Our next question is from Stacy Koo with Cowan. Please proceed with your question.
spk03: 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. So that's the first question. And then the second question is around your ability to, I'm guessing, track the phorosic scripts from your three specialty pharmacies. So can you 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 goals of initial patients, especially for those clinicians that might be aware of phorosics? That's our second question. And then third, you've talked about previously potential targets, patients that are being captured before hospitalization as prevention or post-discharge just to see, to make sure they're completely dry. So is there any, I guess, very, very early initial color on where these patients are coming from? Thank you so much.
spk06: 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 hearing out there, and then three, kind of the patient types. So, Steve, do you want to tackle those?
spk08: Yes. 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, you know, 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, you know, regularly. Of course, there'll be outliers where we see, you know, occasionally outliers. 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, in their heart failure clinics. So that's the targeting. He asked about RXs. 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. I can say 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.
spk06: 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, you know, we don't want the plans to start looking at that and putting quantity limits on it. So, yeah, we've been pleased by what we're seeing from a demand standpoint as well. You know, on the patient types, you know, it's interesting, and this is why sometimes it's a little, it's a little, you gotta be careful what you see early. We are seeing like this, This group of patients where the doctors that know for row 6 is coming have kind of team them up. And as soon as we detail them in service, I think it's important to note Stacy that that you just can't order for row 6 unless you've seen us unless we've done it in service and detailed you on the drug. So you can't get the process direct form. Without 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, it's that after we conduct all the in-services, we'll probably be on a four- or five-week cycle. So we haven't even you know, got to all of our doctors yet because these calls are taking one to two hours. But that's what's most important to us right now. So to go back to the patient types, it is these patients that kind of have 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 drug there. And then obviously patients coming in on sick visits. patients that are coming back after being discharged from the hospital, and patients that 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 nephrosis for those patients. So it's kind of the patient type we thought, maybe with the slight caveat 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 we answered your questions.
spk03: 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, just to make sure, since it sounds like you're really taking the time to make sure. Is that correct?
spk06: So that's not all the calls we have. Okay. Not all the calls. 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 drop right into an in-service. But typically, you want to schedule a law insured in-service because it's not a five-minute call. Now, these calls, we'll start making more and more calls as the in-services, we start in-servicing all the offices. But it's Really a key metric for us is these in-service. So we've done about 3,000 calls and over 300 in-service to date.
spk03: Okay. Thank you for that clarification.
spk10: Thank you. Our next question is from Douglas So with HC Wainwright. Please proceed with your question.
spk00: Hi. Good afternoon, and thanks for taking the question. So, John, maybe as a follow-up, I mean, I guess when you think about the in-service, what is the key 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?
spk06: Doug, I'll let Steve answer that. I will say this. One thing that's been interesting is that, you know, 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, a 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 strain furosemide their entire career. So this isn't kind of a new molecular entity. But Steve, do you want to talk more about?
spk08: No, I think that's a good insight. We've We have changed people's minds on where they think they would use this. They've broadened it. I think everybody comes into the Ferocix experience with, okay, I know exactly where I think I'm going to use it. I can think of a few patients. And then after spending an hour with us or two hours with us and nurses weighing in, saying things that doctors don't necessarily hear every day, medical assistants, the advanced practice providers, We have broadened their consideration pool for who ferocious 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.
spk00: And how can you – so it's going from what to what most commonly? Okay.
spk08: 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 three of those potential use cases.
spk00: Okay, great. Thank you so much.
spk10: Thanks, Doug. Thank you. Our next question is from Naz Rahman with Maxim Group. Please proceed with your question.
spk05: Hi, everyone. Congrats on a recent watch, 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 for your digital promotion efforts?
spk06: And as it's John, let me turn that over to Steve. So, Steve, do you want to?
spk08: So the way we target is it's hospital-based, and then it's all the doctors around that hospital, what we call heart failure community. So we have decile 10 hospitals. We have decile 9 hospitals. We have decile 8, you know, 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. A decile 10 hospital has the most heart failure admissions and discharges in the United States relative to their peers. I think a decile 9s were 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. And so we talk to all the specialists in and around there. So we've, you know, the sales aides were probably high 70s. I mean, 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 failure 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.
spk06: 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 or more. realistic CDOTs. So, but I wouldn't say that 3,000 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 the big clinics 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 will keep expanding out. But, you know, 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 in-services are really important.
spk05: 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 scripts then? 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 a patient gets a letter of medical necessity? Do the letters of medical necessities go through relatively seamlessly?
spk06: So, you know, we have seen the prior auths as we anticipated, and even in our negotiations with the payers, both commercial and Part D. It's the right medicine. You know, they should have failed on oral diuretics, so they shouldn't be sitting here. So that's the prior auth we're seeing, is that it's, you know, they have to have failed on oral diuretics. And it's electronic. It's electronic. look back. So, you know, it depends on the plan on how fast, you know, the scripts are going through, you know, some of them are, you know, 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 a lot of times with any new product, and we're looking at three, three and a half weeks with a new product, you're going to go through a PA. You're going to go through people getting comfortable with it. I think as we move forward, formulary status has come online more that it'll even be quicker. But again, it's just plan by plan right now.
spk05: Got it. And do the letters of medical necessity go through?
spk08: Yes. We have medical exceptions. We don't have to have letters of medical necessity written. But if it is 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 you know whether they've gotten any labs done blood work things like that that they didn't just didn't get they satisfy that and you know more often than not it's it's approved got it thanks for taking my questions thank you
spk10: 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.
spk02: Great. Well, thank you. Thank you very much.
spk06: Appreciate it. We look forward to updating everybody as we move forward. And everyone have a great evening. Thank you very much.
spk10: This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.
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