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spk07: Greetings and welcome to SD Pharmaceutical's fourth quarter and full year 2023 earnings conference call. At this time, all participants are on a listen-only mode. A 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 PJ Kelleher with LifeSci Advisors. Thank you. You may begin.
spk09: 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 within the meaning of the federal securities laws, including but not limited to statements regarding SU Pharmaceuticals' expected future financial results and many expectations and plans for the business and for OSICS. 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 Pharmaceutical's 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 FCC 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 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?
spk02: Thank you, PJ, and thanks to everyone listening to this afternoon's call and webcast to review our fourth quarter and full year 2023 results. As has been our practice, I will begin with an operational update before turning the call over to Steve Parson, our Senior Vice President of Commercial, for a more detailed update on the Ferosix launch, and then Rachel Noakes, our Chief Financial Officer, for a review of our financials. We will then open the call for your questions. The fourth quarter of 2023 represents our third full quarter of Ferosix commercial availability. as we launched the product in late February of 2023. Demand has continued to grow, reflected in our key indicators, including number of doses, number of total prescribers, and doses filled per prescription. We believe 406 is meeting the needs of heart failure patients suffering from fluid overload, and the continued positive trend in these KPIs demonstrates that specialists continue to gain comfort prescribing it. For the fourth quarter of 2023, we reported net revenue of $6.1 million, representing a sequential increase of 61% from $3.8 million for the third quarter of 2023 and at the upper end of the range that we provided in our preannouncement press release on January 4th. This was driven predominantly by doses shipped to patients through our specialty pharmacy network. We also had direct sales of Ferosix to integrated delivery networks. In fact, our fourth quarter net revenue included a sizable order by one of the largest closed IDNs in the country towards the end of Q4. Going forward, while we expect to have sales to IDNs every quarter, including in Q1 of this year, the size of these orders can vary. We'll cover this in more detail shortly. Before diving in further, I would like to note that in the fourth quarter, we adjusted our KPIs from prescriptions to doses, as the number of doses is the metric we use across our internal projections and is more reflective of our current business, especially as the number of doses per prescription varies. Our gross net discount from launch to the end of Q4 was running at approximately 18%, down from 21% to the end of Q3. We continue to expect the GTN discount to increase over time as contracting with payers and the marketplace evolves. We anticipate that the GTN discount Q1 of 2024 will increase relative to 2023 levels due to discounts we anticipate paying. Inventory levels at the end of the fourth quarter at our specialty pharmacy partners were consistent with the inventory levels at the end of the third quarter. Shifting now to payers. We continue to have productive discussions with commercial, Medicare Part D, and Medicaid payers in an ongoing effort to make Ferocix broadly available to patients at the most favorable terms possible. As mentioned earlier, in late October, we reached an agreement with one of the largest closed IDNs in the United States, providing unrestricted access to Ferocix without prior authorization to over 8 million lives at a fixed copay ranging from $16 to $75. Also, as of November 1st, 2023, Ferocix has been added on formulary as preferred brand, one of the largest government retired payer formulary, increasing the number of lives with preferred access to Ferocix by an additional 1.1 million lives. With these favorable payer decisions, we've expanded the population of heart failure patients with access to furosics with fixed co-pays of $100 or less to 70%, moving us closer to our previously stated goal of 75% or more over time. We are progressing with many other health plans, and we hope to have more announcements like these in the months to come. At this point, I would like to provide an update on several long-term growth initiatives that we previewed last quarter that we view as critical for long-term growth strategies. In August, we announced favorable type C meeting feedback from the FDA regarding the potential expansion of the fluorosix indication to allow for use in New York Heart Association class 4 heart failure patients. Fluorosix is currently indicated for the treatment of conjecture due to fluid overload in adult patients with New York Heart Association class 2 and class 3 chronic heart failure. We estimate that as many as 10% of all heart failure patients are class 4 and a meaningful percentage of these, as many as 40%, may benefit from furosis. Based upon the feedback that we received from the agency, we filed for the Class 4 indication early October of 2023. We've been assigned a PDUFA date for this August. We are successful. We believe Class 4 will represent a meaningful expansion of our market opportunity to enable furosis to be prescribed to the most severe heart failure patients. Turning now to the 80 mg by 1 ml auto-injector that we are developing as an additional option to the on-body infuser. We believe that an auto-injector, if approved, would reduce manufacturing costs compared to the current on-body infuser and confer environmental advantages. We remain on track to initiate a pivotal PK study in Q2 of this year and report results later this year. That, if successful, will allow us to submit a supplemental new drug application to the FDA by the end of 2024. Finally, we announced feedback from the FDA pertaining to the potential expansion of the PROSIX indication to include treatment of edema due to fluid overload in patients with chronic kidney disease, or CKD. In its feedback, the FDA confirmed that no additional clinical studies are needed to expand the indication, provided that we can demonstrate an adequate PK and pharmacodynamic bridge to the listed drug which is furosemide injection. CKD is a progressive disease characterized by worsening renal function over time, resulting in frequent episodes of fluid overload that are treated with loop diuretics. It is estimated that 12 to 15 Americans are aware that they have kidney disease, and 50% of patients with CKD do not have a diagnosis of heart failure, with fluid overload being one of the most common complications in CKD, which worsens with disease progression We believe cirrhosis could be beneficial to patients with CKD who have worsening symptoms through the fluid overload and are not responding to oral loop diarrhea. For that end, plan to submit a supplemental new drug application with the FDA for the CKD indication in the second quarter of 2024. Now turning to the first quarter of 2024. Despite the normal Q1 headwinds caused by patient out-of-pocket doctor goals resetting, It's our highest dose demand in shipment for the first half of the quarter. This growth in demand has further accelerated in March. However, the impact of the cyber-attack on changed healthcare began the third week of February and is ongoing. This has caused disruption in claims being processed, resulting in delays in patients receiving shipments of cirrhosis. With the unique position cirrhosis has in the treatment of heart failure patients, we're concerned that we will not see all of these units ship. We're actively working with our specialty pharmacy partners to ship as many of these units as possible. At this point, we do not know if and how much this will ultimately impact the quarter. We intend to provide a more detailed update when we report our first quarter results. At this point, I'll turn the call over to Senior Vice President of Commercial, Steve Parsons, for a deeper dive into our launch metric. Steve? Thank you, John.
spk08: As John indicated, the fourth quarter was our third full quarter of Furosic's commercial availability, and we remain pleased with our progress. From launch through December 31st, we've had 1,696 unique prescribers, up 52% from the 1,119 unique prescribers from launch through September 30th. We're extremely encouraged by this growth as it reflects our strategy in 2023 of establishing a broad prescriber base. Importantly, more than half of these prescribers had written multiple prescriptions by the end of the year. During the fourth quarter, we had 13,542 doses written and 7,016 of those doses have already been filled. There were another 4,592 doses that were still pending as Q4 ended. We continue to report doses written and doses filled because of the unique nature of how physicians prescribe cirrhosis. Many of our physicians write prescriptions for patients in anticipation of future need due to worsening fluid overload. While these prescriptions might not be filled in the month or quarter they are written, they do get filled when the patient needs treatment, and we report these doses when the patient receives them. It is important to note that approximately 14% of our prescriptions were canceled during the fourth quarter of 2023. Recall that pending prescriptions are not canceled. Rather, they are still in process with the payers. Some are approved and waiting in queue, while others are still in prior authorization. We filled a significant portion of these pending prescriptions in the first few weeks of 2024, and we continue to fill more pending prescriptions written in Q4 into the filled category every day. Now, the prescriptions that are canceled are for various reasons, including unreachable patients who are hard to contact, have been hospitalized, or a small number that are deceased. Of those that are reached who cancel, a high copay is the main reason given. We anticipate the cancel rate will continue to decrease with furosics, as it's expected to become better positioned on more health plan formularies, lowering patients' out-of-pocket costs and providing quicker coverage decisions. During the fourth quarter, the average number of doses per prescription filled was 5.9 doses, which remains higher than our long-term expectations. Our sales force has conducted 2,331 in-services as of December 31st, which is up from 1,806 in-services conducted as of September 30th. In-services provide important training to offices on the prescribing process for forensics, and this ensures office readiness. As we open more new accounts, the execution of inservices remains fundamental to furosic success, and we regard the number of inservices conducted each quarter as an important leading indicator. We've said previously that we stand ready to add additional territories as demand warrants. We plan on adding additional territories in advance of our Class IV and chronic kidney disease initiatives. From a marketing perspective, we are engaged in a broad multi-channel marketing campaign to drive brand awareness, adoption, and commitment. This program encompasses many different activities, but some of the key ongoing activities include engagement and development of key opinion leaders, conference presence, print and electronic collateral, and the development of both provider and patient websites, among other critical tasks. We've begun reaching out to heart failure patients and their caregivers with patient education materials Overall, we're pleased with our progress, our continued progress, and the path we are on. That concludes my update. I'd like to turn the call over to our Chief Financial Officer, Rachel Notz, for a financial update. Rachel?
spk05: Thank you, Steve. As of December 31, 2023, we held $76 million in cash, cash equivalents, and investments compared to $118.4 million as of December 31st, 2022. Now I will cover a few income statement items. We reported a net loss of $13.8 million for the fourth quarter of 2023, compared to a net loss of $9.2 million for the fourth quarter of 2022. For the full year 2023, we reported a net loss of $54.8 million compared to a net loss of $36.8 million for the full year 2022. Product revenues were $6.1 million for the fourth quarter of 2023, and cost of product revenues were $1.8 million. For the full year 2023, product revenues were $13.6 million, and cost of product revenues were $3.8 million. We did not generate revenue during the fourth quarter or full year 2022, as Bureau 6 was approved in October 2022 and commercially launched in February 2023. Research and development expenses were $3.3 million for the fourth quarter of 2023, compared to $2.3 million for the comparable period in 2022. The increase in research and development expenses for the quarter ended December 31, 2023, was primarily due to an increase in device and pharmaceutical development costs. The increase was partially offset by a decrease in employee-related costs. Research and development expenses were $11.8 million for the full year 2023, compared to $15.5 million for the full year 2022. The decrease in research and development expenses for the full year 2023 was primarily due to a decrease in clinical study and medical affairs costs, employee-related costs, and quality and regulatory consulting costs. The decrease was partially offset by an increase in pharmaceutical development costs. Selling general and administrative expenses were $16.2 million for the fourth quarter of 2023, compared to $7.2 million for the comparable period in 2022. The increase in selling general and administrative expenses for the quarter ended December 31, 2023, was primarily due to an increase in employee-related costs and commercial costs. For the full year 2023, we reported selling general and administrative expenses of $53.4 million compared to $20.6 million for the full year 2022. The increase in selling general and administrative expenses for the full year 2023 was primarily due to an increase in employee-related costs and commercial costs following the commercial launch of Hero6 in February 2023 as well as an increase in legal costs. The increase was partially offset by a decrease in insurance-related costs. Based on our current operating plan, we expect our operating costs to increase in 2024 as we further support the launch of Euro 6 and the development of the 80 makes by 1 ml auto injector. As of December 31st, 2023, we had 35,968,510 total shares outstanding. That concludes the financial update. John?
spk02: Thanks, Rachel. This concludes our prepared remarks. At this point, we will open the call for questions.
spk07: Thank you. Ladies and gentlemen, at this time, we will be conducting a question and answer session. If you'd like to ask a question, you may press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would 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 key. Our first question comes from the line of Rolana Ruiz with LearWink Partners. Please proceed with your question.
spk06: Hi, everyone. Rosa Chen on for Ron Ruiz at Lyric Partners. Thanks for taking our questions. So first one from us, can you guys share some additional details on your efforts securing more additional IDN agreements and how you expect that could impact some of the current trends that you're seeing in the uptake of furosics by the individual prescribers?
spk02: Sure, Rosa. This is John, and I'll let Steve jump in. So, you know, the two largest IDNs in the country are Kaiser and the VA, the VA being the largest. And, you know, we're working with the VA. We've been selling into individual VAs. This year, a key initiative for us is to be a national formulary for the IDN, I mean, for the VA. We think that'll drive uptake. And then with Kaiser, more of a closed system where we've already struck the contract and we have sales in there. We think those two kind of are a little unique in that they're really the closed integrated system. And you have Geisinger, who's one of those as well. So we'll continue to sell into those really hard closed systems. But we really see a big expansion opportunity into what you would call IDNs that might not have the closed part of the pharmacy involved. So the docs might be employees, but they're not in the pharmacy. They don't have the pharmacy benefit. This is good for us because we can still talk about the 406 value message, but also be able to track the prescription. So those would go through our regular distribution network. But we anticipate that growing as a percentage of the business. There's still a lot more patients outside of the IDN world than there are in it, but we've always thought that this would be a good market for us as the value proposition is so well defined. I don't know, Steve, if you want to add anything to that.
spk08: Yes, we get approached by integrated delivery network hospital systems quite regularly, and they see an opportunity to shorten the length of stay in some cases by having the product available right there on campus, as well as preventing unnecessary readmissions, which they pay penalties for. So they'd like to be involved in the furos distribution directly and have their doctors order it right through their EMR systems in the hospital. So there'll be more and more of that happening this year.
spk06: That's helpful. Thanks. And a second one from us on your CKD label expansion effort. So thinking of the potential launch there, if it's approved, and the nephrologist you may call on, what learnings from your current 406 launch would you apply there and anything you would do differently specifically for that patient population and prescriber base?
spk02: So, when we look at nephrologists, you know, they actually prescribe, they're more productive in a way than the cardiologists around how many loop diuretics they use. So, I think, again, one learning we've had early on, and I think this will apply to nephrologists as well, is really that treating that patient as soon as that patient starts showing a reduced response to the oral diuretic is critical, critical to get that patient feeling better, critical to keep that patient from being totally fluid overloaded. That message in our market research really plays well to the nephrologists. In fact, when we look at any of the market research with nephrologists, I think they understand the value prop. I think they're going to embrace it, we would think, perhaps even earlier than cardiologists.
spk08: I mean, Steve, I don't know. We've been calling on a small number of nephrologists already due to them having heart failure patients with fluid overload. Some of them are seeing cardiology patients that have been referred to them to deal with the fluid overload. So we're calling on them already, and they're very anxious to have the broader indication to include CKD.
spk02: Yeah, we've been very enthused, and I'm not sure, John Moore, if you want to add anything. He's done most of the work on kidney, but we've been incredibly enthused with the response of the nephrologist to the product profile, the value prop. And there's less of them, so we can cover more of them with our sales force. So we're anticipating really a quicker uptake in nephrology than we've even seen in cardiology. I'm not sure, John, if you have anything you'd like to add to that since you've done multiple. Sure, I'll respond.
spk03: Yeah, I'll just add that when doing research and talking with nephrologists and you hear the story and you hear the description of the problem that they're describing in their patients with chronic kidney disease, if you didn't know that they were nephrologists, you'd think that they were cardiologists. They're describing the exact problem. same problem. And so when a patient reaches out to their nephrologist for worsening signs and symptoms of fluid overload, the nephrologist is inclined to treat them. They don't say, well, go to your cardiologist and let your cardiologist do it and vice versa. So it's the exact same problem, just different individual being presented. And now that nephrologists will have the opportunity, they'll use it just like the cardiologist do, just additional touch points. Great.
spk06: Really appreciate the perspective. So last one, I'm going to squeeze one in. Can you just share the range in doses that you're seeing right now for cirrhosis? You mentioned the 5.5 average. What's the range?
spk02: So the range, you know, we, you'll see, you know, every once in a while, a script for one unit. I think usually that's something weird going on, but, but typically it's, it's, it's two or three. I think the maximum you'll see is eight and that's for a, A patient's fairly volume overloaded who's in a pre-admission, but I think you're looking at two to eight is the range.
spk06: Great. Thanks so much, guys.
spk11: Thank you, Rose.
spk07: Our next question comes from the line of Stacy Koo with TD Cowen. Please proceed with your question.
spk06: Hi. Thanks so much for taking our questions. We had a few. First, Steve, I understand you're currently focused on establishing the infrastructure and driving uptake for prescribers, but just curious your views on expanding patient activation for DTC, especially as reimbursement continues to progress. And we have a few more questions, so we'll just kind of lay them out first. As you also broaden out the prescriber base, are you helping these clinicians get a good sense of which patients will have reasonable copays just to help kind of ease the prescribing for the clinicians as they think about appropriate patients and as we think about long-term improvements and fulfillment. And then just to follow up your comments around the changed healthcare, clearly that cyber attack is a pretty well-understood issue at this point, but curious if you could provide any other additional details. Is this just a delay in adjudication for co-pays from Q1 to Q2 as you implement kind of the temporary workarounds? Do you anticipate any prescriptions will be lost? And then last question, if we may. When do you think you might break out that ID and contribution, and what are your thoughts about what types of disclosures? Thanks so much. I can repeat the questions if needed.
spk02: Okay. I wasn't writing fast. Let me do the first one again. I think I'll take them from the end. I'll talk about change first. You know, as I said, what's happened since February 21st when the system went down, is really the prescriptions coming in, being able to adjudicate them, copays, and ship them. So we have, I think I said it in my prepared remarks, our demand, the number of prescriptions and units being written is way higher than at this time quarter to date, last quarter, dramatically different Obviously, our units filled is higher, but it's lagging the prescriptions because of the delays we're seeing. So your question is, is it just the delay? Do you lose some of them? You know, I think that's the big question is, yes, they're delayed, but do you get them back? We have a workaround with our specialty pharmacy partners. We're hoping change comes back up fully online here. They've said next week. And the question is, you know, can we ship everything that we should have shipped? And we're just not sure of that right now. We don't think, you know, unless something weird happens, it's a long-term issue. And we remain optimistic about making, you know, consensus for the year. But this, you know, this is a disruption for us Right now, you know, again, it started February 21st. It's ongoing now. We have a workaround. We've been shipping units, just not as many as we should be because of the slowness of the system. We talk a little bit, so that's the first question, to talk a little bit about the reporting of the IDN. It will depend on the IDN and in our contract with them of what metrics we can report. You know, we could break the sales out. I think we've said that, you know, for Q4, you know, we think it, you know, it was in the 10 to 15% range for the IDN purchases. That'll vary. Again, we had a large purchase at the very end of the year from Kaiser. We don't have visibility into what, Kaiser doesn't let you see what doctor wrote. They don't want you detailing the doctors, which is crazy. But some of the IDNs that Steve mentioned, the hospital-based ones, will have more metrics to be able to share. But unfortunately with Kaiser, I think the metrics are going to be somewhat scarce. And then Steve, do you have the other questions?
spk08: You asked about helping doctors identify patients who are going to have, what the co-pay is going to be for those patients so they can have success. And yeah, we can do that. You know, we're we're pretty confident, like 70% of our patients are able to access furosematic copay of $100 or less, some of them much less. Like the average copay for the patients with $100 or less is the $20 range. So you can imagine anything, $0 copay, $10, $50. A lot of the doctors are now they're submitting prescriptions in advance of needing the product, anticipating that they're going to need Ferozix for a specific patient who's going to worse and it's just a matter of time. And they get a cost and coverage feedback. They get an answer. And they get an approval on the product. They know the co-pay is good. And then when the patient does get sick and does need it, that's when they call it down And it's ready to go very, very quickly. So they'll tell the patients who have the really good copays, no hesitation at all. And some people who have a higher copay, they may not talk about the product to them until there's foundational charitable funding support for those. So I don't know if that answers the question, but they are able to get preclearance on a lot of these patients and know who has the really good copays.
spk06: That's really helpful. And then the first question we asked was really curious your thoughts around activating patients by DTC. Now you're focused on the prescribers right now, but as you progress your reimbursement, as you get the auto-injector, what are your thoughts there long-term?
spk08: Yeah, we have a plan. We have a strategy to reach directly out to patients and their caregivers. We did an awful lot of market research to be ready so that we know how they like to be communicated to. you know, how to reach them, where to reach them. We've begun in-office direct-to-patient with brochures and the doctors giving them out things. And we're building a website just for patients. We have advocacy groups, Mended Hearts and Heart Brothers that are connecting us with patients through their networks of people who have opted in and signed up. So the patient is a big focus for us this year. More than it was in year one.
spk02: We spent the first 12 months, as our plan was, educating cardiologists before we educated patients. So this year, there'll be a lot more targeted outreach to patients and to caregivers. You know, we're going to be doing a giant DTC campaign, you know, on Survivor or something. Probably not. You won't see that. But I think you'll see some targeted things to patients, including potentially media as well.
spk06: Wonderful. That's really helpful. Thank you for all the details.
spk11: Thanks, Jason.
spk07: Our next question comes from the line of Douglas So with H.C. Wainwright. Please proceed with your question.
spk01: Hi. Good afternoon. Thanks for taking the questions, and congrats for the progress. So, John, I'm just curious, in terms of the Change Health, I mean, what percent of your business has been affected by this? Because it really – you know, was it really just United and that one payer?
spk02: No, it's, Doug, it's really, so you think of United, United owns or often owns, United owns change. But, you know, our specialty, you know, most of all of the specialty pharmacies and of the payers use change healthcare. So the adjudication of the scripts go through change. So So you could say all of our scripts for that period of time and ongoing are impacted. Now, that said, it was really slow for a couple of days because what happened was everything had to be called in manually and everyone was doing the same thing. So it was incredibly slow. We have managed workarounds. There's another system in place called Relay that one of our other specialty pharmacies utilizes. So we were able to move business there. That's slow as well, but I think the workaround has started to work and really what we need to do and what we're focused on is making sure we ship all of those scripts that were caught up when it was totally down and we didn't have a workaround. I'm not sitting here saying it's working smoothly now. It's obviously with the workaround working better and I think especially pharmacies are getting better at working through the limitations in the system. We've heard that it'll be coming back online here next week. So we're going to continue the work we've asked, especially pharmacies, to put more people on, to man the phones, to ship the drug. So if you ask what percentage of our business got impacted, the question would be what percentage of the business what percentage of units prescribed aren't going to ship that should have shipped? That's the question. That is relevant. It's impossible for us to give you that final answer right now. We have recovered a good portion of it. Have we recovered all of it so far? No. The good thing is we're still seeing the demand come in very robustly. The docs are still writing, and they're writing kind of more than they've ever written We just need to be able to keep up, ship what's coming in now, and then deal with those that are still sitting in the system.
spk01: Okay, that's helpful. And then also just are you, in terms of nephrology, are you starting to see any off-label scripts being written? I mean, I know it's challenging in terms of getting paid for, but I'm just curious. Some plans are somewhat liberal.
spk02: Mm-hmm. We haven't. You know, when we mentioned that we go to some nephrologist. So you'll see a lot of times even the cardiologists will say, boy, they have heart failure and CKD. I just let the nephrologist take care of it. So that's on label for us. That's part of our heart failure TAM is those patients, even if they're cared for by a nephrologist. So that would be on label. Now, if it's class four, it wouldn't be. But if it's two and three and it's in nephrologists and they have heart failure, then that's all labeled and will get filled. If they wrote it and it was CKD, first off, we wouldn't be promoting that at all. Second off, it probably will not be filled.
spk11: Okay, great. Thank you. Thanks, Doug.
spk07: Our next question comes from the line of Chase Knickerbocker with Craig Hallam. Please proceed with your question.
spk10: Good afternoon, guys. I'll share my congrats on the progress as well. Maybe to start, where are we at from an average time for adjudication of the PA's perspective? And give me, you know, the average time, I guess, before the change healthcare disruption. And then since then, should we just think of it as, you know, a lot of those adjudications have just been, you know, almost completely paused and that's what's causing this underlying disruption that you're talking about that, again, everybody's experiencing?
spk02: Yeah. Yeah. we couldn't tell you what the average time is since since change went down i mean it it it's variable um you know and we've got workarounds now you know we still have our primary specialty pharmacy that goes through change that is adjudicating claims for change and then they get triaged um if if to relay if there's an issue so That is an impossible question for us to answer. Now, again, the thing here, Chase, is the data itself is very hard to even get your hands on. We know the scripts coming in. That we can see clearly. It's what's going out, when they went out. And again, we've got a workaround that involves a couple other specialty pharmacies. And so the data is kind of some report it differently. So prior, you know, after change, there's just no way this soon we can tell what that is. I don't know, Steve, if you want to talk about that before the change impact.
spk08: Yeah, not ever trying to be evasive, but it's a really multi-factor question on how fast prescriptions get filled. It depends on what the doctor wants. We have two ways for the doctor to order the product. They can check expedited 24-hour reviews meaning they want it as quickly as possible, or they can check coverage and cost determination. And that one, that's more of the layaway. And that could sit there after it's approved very, very quickly with a known copay. That could sit there for weeks until the doctor wants to call it down. Now, let's just focus on the ones where they say, I want it as fast as possible. Our brand promises we'll get them something the very next day. When we get a quick answer from the payer and we reach the patient, we are able to ship it for a next day delivery. If we don't get a quick answer from the payer, we'll still ship them one dose overnight for free so that they have something the very next day, and then it buys us another 24 hours to get through to the payer, get the answers, and then ship it out for the following day. So that's been working well. very well to the satisfaction of our prescribers. But to do an average, when you add in all these ones that purposely can be there for weeks or even months, we're filling prescriptions this quarter where people wrote them in October or November, and they're finally calling them down. We're very happy to have them. We do not discourage the doctors from ordering in advance and getting it pre-approved. They like to do that. We like to see them doing that. But it does impact both our fill rate as well as our speed to dispensing.
spk10: Yeah, it makes sense. I certainly appreciate the complexities there with that answer. Maybe some color. Just based on some of the color you've given around gross to net and where you expect it to end the year, that indicates that you expect to contract with some of these large Medicare Advantage payers. at some point, you know, call it earlier mid-year this year in 2024, just kind of speak to some of that activity and the conversations that are happening in the background that kind of give you the confidence to kind of assume that those contracts are going to get done.
spk02: Yeah, so we've had ongoing negotiations with, you know, there's four big payers here in Medicare. And, you know, we've talked about it that, you know, You know, when we first went out, they didn't agree with what we offered them. We didn't agree with what they offered us. We've had a couple iterations of that. These aren't quick iterations. You don't pick up the phone call, pick up the phone and call on Tuesday and they give you an answer on Wednesday. So it takes some time, but we're making progress. You know, we think it's key if you look at, especially next year, that we're on formulary here because of how the Part D is going to reset. But we have to get these done for this year too. So, you know, we're pretty confident that it's going to happen this year. And that's why we keep messaging that the GTN is going to go, the discount is going to go up because we're going to be paying these rebates. And again, we're not paying them unless we think it makes sense for the brand. But we do think being able to lower co-pays for that 30% of the patients to get them to $100 or less, and also to speed adjudication time is important for the brand to go where it's going. So they're progressing. You know, we said once we sign them, we'll announce them, and we still plan on doing that.
spk11: And, yeah, that's the plan. Great. Thanks for the call, guys. I'll hop back in queue. Thanks. Thanks, Jason.
spk07: Our next question comes from the line of Nev Raman with Maxim Group. Please proceed with your question.
spk04: Hi, everyone. Congrats on the progress. So just a couple of questions for me on your CKD indication. So the first one is, what kind of review cycle do you expect? Do you expect a six-month review or a one-year review for the product? or for the indication label? And two, how do you think the reimbursement conversations and reimbursement paradigm sort of evolved for this indication? Like, are you already having discussions with payers regarding this potential label expansion? So you might see that benefit upon approval, or do you have to kind of go back and have additional discussions and we might see the benefit of those discussions and reimbursement sometime later in 25? Like, how do you think that would progress?
spk02: Yeah, I'll take the first one, Steve, you take this one. As we anticipate a 10-month review, it's not a new molecular entity, which would be a 12-month, but we anticipate, and again, we've said we're filing next month, and we will file in April. We'll receive our PDUFA date, but we anticipate that would be 10 months. Is there a chance it could be six months? There's always a chance, but I think to be conservatives, we'd say 10 months. But there wouldn't be a way that it could be 12 months. There's not really a path that way. We expect a pretty straightforward review. You know, the IV has CKD in their label. We're matching the label of the IV. We did a PK study that matched the PK of the IV. So we think it's a pretty straightforward review. And as I said before, we're excited. Steve, do you want to talk about?
spk08: Yes. Well, we're not negotiating for CKD at this stage. Payers don't really want to do that. But we do know with pretty good assurance that cirrhosis will be covered the same way it is for heart failure with CKD. It'll be a simple prior authorization to label. And that prior auth means they have to be trying generic oral diuretics and that's just not working before furosics would be approved for an acute intervention. So it'll be essentially the same PA to label or label will have CKD and it won't be any more complicated than that.
spk02: There's exceptions where the plans will We'll start a review prior to approval. It's pretty rare. It's pretty rare, though, that they spend the time to really, you know, start reviewing a product or an indication prior to approval. Again, they do it with, you know.
spk08: When things are under review at the FDA, they're more likely to. We have to file first. Yeah, exactly.
spk04: Thanks, that was helpful. And just one last question. So I think you, in your remarks, you said you plan on expanding the commercial force for 406. Could you comment on what the magnitude of that expansion would be? And does the impact of change impact your timing decision-making there?
spk02: There'd be no impact unless change went for months here, right? Which we don't anticipate. I don't think anyone anticipates that. you know, there's no impact on how we're looking at expanding the sales force at all. So I think what our thinking has been is that to expand it to 90 here mid-year in front of the Class 4 approval, and then to 125 very early next year in front of the CKD expansion. That's the thinking right now, but there'll be no impact from change healthcare on that.
spk04: Thanks a lot. Thanks for taking my questions.
spk11: And once again, congrats on the progress. Thanks. I appreciate it. Okay.
spk07: If there are no further questions in the queue, I'd like to hand it back to management for closing remarks.
spk02: Great. Thank you very much. That concludes our call this afternoon. We remain pleased with the trajectory of our Perosix launch. We expect that the meaningful progress that we're making with payers will add to our momentum its heart failure patients gain affordable access to cirrhosis. We're excited about our lifecycle initiatives after having productive discussions with the FDA and look forward to providing some updates as we progress through 2024. Overall, I'm pleased with our progress and believe that we can build on our current momentum and look forward towards a successful year. Thank you again and have a great evening.
spk07: Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation. You may disconnect your lines at this time, and have a wonderful day.
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