Thank you for standing by, and welcome to Cara Therapeutics' Q2 2023 Earnings Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 11 on your telephone. To remove yourself from the queue, please press star 11 again. I would now like to hand the call over to Matt Murphy, Investor Relations. Please go ahead. Thank you, operator, good afternoon. After market close today, Cara issued a news release announcing the company's financial and operating results for the Q2 of 2023. Copies of this news release and the associated SEC filing can be found in the investor section of our website at www.caratherapeutics.com. Before we begin, let me remind you that during the course of this conference call, we will be making certain forward-looking statements about Cara and our programs based on management's current plans and expectations. These statements are being made under the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties. Actual results may differ materially due to various factors, and Cara undertakes no obligation to update or revise these statements publicly as a result of new information or future results or developments. Investors should read the risk factors set forth in Cara's 10-K for the year ended December 31, 2022, and any subsequent reports filed with the SEC, including its Form 10-Q for the quarter ended June 30, 2023. With that said, I'd like to turn the call over to Chris Posner, Cara's Chief Executive Officer. Chris? Thanks, Matt. Good afternoon, everyone, and thank you for joining our call. With me today are Ryan Maynard, our Chief Financial Officer, Dr. Joanna Konsalvo, our Chief Medical Officer, and Scott Terillian, our General Counsel and Head of Government Affairs. I'd like to start by giving a quick overview of what I'll address today. First, I will give an update on the Korsuva injection launch in the U.S., including clinic-level data to provide visibility into underlying demand trends across the different segments of the dialysis market. I will also briefly touch on the proposed calendar year 2024 ESRD PPS rule, which CMS published in late June. Next, I will review the Kapruvia launch progress in countries around the world. Then, I will discuss our wholly owned pipeline and the progress of our three late-stage programs for oral difelikefalin. Finally, Ryan will provide a financial update, after which we will open up the call to Q&A. With that, let me discuss the Korsuva injection launch in the US. For the Q2 of 2023, net sales for Korsuva were $11.4 million, translating into $5.4 million of profit recorded as revenue to Cara. Wholesaler shipments to dialysis clinics totaled approximately 67,000 vials, a 46% increase from the prior quarter. 67% of these vials were shipped to FMC clinics, with the remainder split between DaVita and the other DOs. This increase in vial shipments suggests a continued drawdown of inventory at FMC and an acceleration in demand across all DOs. Ongoing anecdotal feedback on Korsuva from both providers and patients remains highly positive, highlighting that Korsuva addresses a significant unmet need. At FMC, orders grew by more than 50% quarter- to- quarter, reaching 45,000 vials. By the end of the Q2, over 700 FMC clinics, or 27%, had placed reorders. That's up from 18% at the end of the Q1. More importantly, 1,300 clinics, or 50%, had dosed at least one patient. That's up from 42% at the end of the Q1. Note: this is a correction. Based on numbers provided to us by FMC, we reported on our Q1 call that 1,500 clinics had dosed at least one patient. The growth in the number of FMC clinics reordering, as well as clinics dosing a patient, suggests continued drawdown of inventory at the clinic level. If this trend continues at the current rate, we believe that the majority of FMC clinics will have depleted their inventory and will be in reorder mode this year. At DaVita, we are seeing continued steady growth in demand. Orders grew by 43% quarter-to-quarter to 11,000 vials. Over 400 clinics, or 15%, had ordered Korsuva at the end of the Q2. That's up 11% at the end of Q1. Reorder rates remain very encouraging, with 73% of clinics placing repeat orders. Given the on-demand approach at DaVita clinics for ordering Korsuva, the growth in clinic orders represents a good proxy for the growth in patient demand. At midsize and independent DOs, Korsuva utilization continues its momentum. Orders grew by 28% quarter-to-quarter to 11,000 vials. At the end of the Q2, 17% of clinics in this market segment had placed orders. That's up from 13% at the end of the Q1. In addition, 68% of these clinics placed repeat orders, that's up 66% at the end of the Q1. USRC remains the largest buyer of Korsuva in the MDO and IDO segment. 73% of USRC clinics had ordered Korsuva by the end of the Q2, 80% of these clinics had placed repeat orders. While Korsuva continues to make meaningful progress in the US, a majority of the market remains untapped, there is significant room for growth. Our partner, CSL Vifor, is fully committed to driving Korsuva's uptake in this unique ecosystem, with the goal of maximizing its commercial potential in the long term. Now, I will briefly touch on the ESRD PPS proposed rule for calendar year 2024. This rule, once it is final, will determine the framework for Korsuva's reimbursement after its TDAPA period. In late June, CMS proposed a new add-on payment adjustment for certain new renal dialysis drugs after their TDAPA period ends. The post-TDAPA payment adjustment applies to all dialysis treatments for a period of three years, immediately following the expiration of the drug's TDAPA period. The proposed methodology calculates the add-on payment for each treatment based on the prevailing ASP and the drug's utilization during the most recent 12-month period. CMS also proposed a risk-sharing arrangement with ESRD facilities, calculated at a 35% discount to the prevailing ASP to account for any declines in other drug expenditures. We are pleased that CMS proposed additional funding that is not budget neutral for innovative TDAPA-designated drugs that fall into an existing functional category. We are also glad that the new funding starts immediately after the expiration of the TDAPA period and gets adjusted annually by the market basket update. However, there are certain limitations to the proposed methodology, which we plan to pointedly address with CMS in the coming months. Specifically, the add-on payment applies to all dialysis treatments and does not follow the patient. In addition, a 35% discount to the prevailing ASP does not take into account first-in-class drugs like Korsuva that don't have a therapeutic substitute. Since the proposed post-TDAPA reimbursement methodology makes a drug's uptake during its TDAPA period a key factor in future reimbursement rate setting, we plan to also address the question around appropriate utilization data with CMS near term. More specifically, we will be laying out a case for additional TDAPA time. We will furthermore press for changes to the proposed methodology to account for innovative, first-in-class products that target a minority of ESRD patients. We will continue to work closely with CMS and provide information to highlight the best solution for broad and equitable patient access to innovative drugs like Korsuva in the final rule, which is expected later this year. Next, on the international front, the rollout of Kapruvia in Europe is progressing well. In the Q2, Kapruvia generated $1.2 million in net sales, translating into $123,000 of royalty revenue to us. Launches have begun in seven EU countries, with more lined up in the coming months. CSL Vifor continues to report positive feedback from patients and providers, in line with the testimonials we have received in the US. We are pleased with the recommendation by England's National Institute for Health and Care Excellence, or NICE, for Kapruvia for the treatment of moderate to severe chronic kidney disease-associated pruritus in adult patients on hemodialysis. In Japan, we continue to expect a regulatory decision in the second half of this year. As a reminder, approval in Japan would trigger a $2 million milestone payment to Cara. We are pleased with the progress around the world and believe the success of the ex US launch to date underscores the significant unmet need for an effective antipruritic treatment for hemodialysis patients. Last but not least, let me touch on the development progress of our innovative, wholly-owned pipeline. Enrollment in our phase III programs and pruritus associated with atopic dermatitis and advanced chronic kidney disease is progressing well. We anticipate the internal readout of Part A of our KIND 1 AD trial in the Q4 of this year, with final top-line results from this program in the first half of 2025. We continue to expect top-line results for our KICK program in advanced chronic kidney disease in 2024. Our phase 2/3 COURAGE trial in notalgia paresthetica commenced in the Q1 of 2023 and is tracking to the internal readout of Part A in the second half of 2024. We expect top-line results for the COURAGE program in the first half of 2026. We strongly believe that oral difelikefalin is the centerpiece of our strategy of becoming the leader in the treatment of chronic pruritus and the key to unlocking the long-term value of Cara. We remain committed to driving progress of our pipeline and building our unique nephrology and medical dermatology franchises with oral difelikefalin. To summarize, we are pleased with the continued progress of the U.S. Korsuva launch, as evidenced by the acceleration in vial shipments and reorder rates across the dialysis landscape. Following CMS's proposal for a post-TDAPA add-on payment, we are engaging with CMS to discuss potential modifications to the proposed methodology, as well as an extension of Korsuva's TDAPA time. We hope to see meaningful changes reflected in the calendar year 2024 final rule later this year. Internationally, we continue to receive positive feedback from the rollout of Kapruvia, and we are optimistic about the growth trajectory as more countries come online. We also continue to execute on the most significant long-term value driver of our company, our differentiated innovative pipeline. Our three late-stage programs with oral difelikefalin have potential for tremendous value creation and set us apart as a leader in chronic pruritus. We remain laser-focused on advancing these programs in order to maximize the potential of difelikefalin within our two exciting therapeutic franchises. I would now like to turn it over to Ryan for additional details on our Q2 financial results. Over to you, Ryan. Thank you, Chris. Total revenue was $6.9 million for the three months ended June 30th, 2023, compared to $23 million for the same period in 2022. Revenue this quarter consisted of $5.4 million of collaborative revenue related to our profit from CSL Vifor's net sales of Korsuva injection, $1.4 million of commercial supply revenue, and $123,000 of royalty revenue, representing our royalties from net sales of Kapruvia. Revenue in the same period last year included a $15 million milestone payment for the approval of Kapruvia by the European Commission, as well as $8 million of collaborative revenue related to our profit from CSL Vifor's sales of Korsuva. Cost of goods sold during the three months ended June 30th, 2023, was $1.4 million and relates to our commercial supply shipments of Korsuva injection to CSL Vifor. There was no cost of sales during the three months ended June 30th, 2022, as there was no commercial supply revenue from CSL Vifor. R&D expenses were $30.3 million for the three months ended June 30th, 2023, compared to $19.9 million in the same period of 2022. The increase in R&D expenses is primarily due to the increased clinical trial spend related to our three late-stage clinical programs, partially offset by decrease in stock-based comp. G&A expenses were relatively flat at $7.5 million for the three months ended June 30th, 2023, compared to $7.6 million in the same period of 2022. Cash, cash equivalents, and marketable securities at June 30, 2023, totaled $101.7 million, compared to $123.4 million at March 30, 2023. The decrease of $21.7 million this quarter was primarily due to cash used in operating activities. We expect that our current unrestricted cash, cash equivalents, and available-for-sale marketable securities are sufficient to fund our currently anticipated operating plan for at least the next 12 months. This guidance assumes all the spend related to our three late-stage clinical development programs and Korsuva revenue profit share contribution. We continue to work to extend our runway past the guidance by focusing on non-dilutive funding sources. Back to you, Chris. Thanks, Ryan. I want again emphasize our confidence in the commercial potential of Korsuva, Kapruvia in Europe, as well as the tremendous upside of our pipeline for oral difelikefalin. We continue to believe that our long-term strategy will make Cara the leader in the treatment of chronic pruritus and will deliver meaningful value to our shareholders. With that, Ryan, Joe, Scott, and I will be happy to take your questions. Operator, you could please open the line for Q&A. As a reminder, to ask a question, you will need to press star one, one on your telephone. Again, that's star one, one on your telephone to ask a question. To remove yourself from the queue, you may press star one, one again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Dennis Ding of Jefferies. Hi, good afternoon. Thanks for taking our questions. Congratulations on all the progress in the Q2. 2 questions from me. Maybe, you know, how do you guys think about the trajectory in the second half and the shape of the launch curve? I mean, outside of the, you know, outside of depleting inventory, what else needs to happen for the trajectory to really inflect in the back half of the year? My 2nd question is around the CMS draft documents. Maybe remind us what you are looking for or pushing for in the final ruling in the fall, and what would be considered a big win for Cara? Thank you. Yeah. Thanks, Dennis. Nice hearing from you. The first question, expectations for the remainder of the year. You know, while we and our commercial partner, CSL Vifor, are not providing forward-looking guidance at this time, you know, here, here's what I will say. You know, we're certainly very encouraged with the accelerating trends in our key metrics, namely vials being ordered by clinics that increased 46% versus the prior quarter. You know, in addition, I, I mentioned in my prepared remarks, we're also seeing more and more clinics dosing patients, specifically at the two LDOs. We're at FMC, Dennis. You know, we're at 1,300 clinics dosing. That's roughly a 50% penetration. At DaVita, you know, we're about 410 clinics now dosing, but importantly, that's up over 40% versus the prior quarter. Most importantly, you know, IV Korsuva is really holding up in the clinic, and the feedback from both patients and providers has been highly positive. The reorder rates, meaning once a clinic starts dosing patients, there is significant buy-in to the product, as over 70% of these clinics continue and consistently place additional orders. And I'll just conclude with this, Dennis. You know, although we're kind of early in Q3, I can tell you that the growth we see coming out of the Q2, we are seeing continue in the early part of the Q3. And our commercial partner, CSL, CSL Vifor, continues to be highly motivated, and their promotional efforts continue in full force. That's what I'll say about the second half of this year and our expectations. On CMS, let me introduce Scott, who heads up our government relations, in addition to being our General Counsel, who has, who has led the efforts with CMS over the last couple of years. Scott, maybe you could address what we're doing with CMS. Sure. Thanks, Chris. Yeah, as Chris said in his remarks, with regard to the rule, we're pleased that there was new money added. That's, that is great, and that's a very meaningful movement forward. In our interactions with CMS, and it's not just us, the broader community is also taking up very similar issues with CMS. There's three things with regard to the proposed rule that we're gonna be looking for. One is having the money follow the patient. That's particularly important with a product like Korsuva, where it is gonna be used in a minority of patients. We wanna make sure that the funding and the reimbursement is tied to their clinical decision directly to make sure the patients get access to the product. The second thing we're gonna be talking about is the 35% discount. Again, we do agree that some sort of set off for savings for drugs that are not going to be used in the bundle as a result of the, of a new drug ought to be offset in some way. That's good fiscal policy. Makes a lot of sense. However, with a drug like Korsuva, where there isn't any money in the bundle, there isn't any money being spent to treat these patients or manage a condition before Korsuva, we think it's important that the set off is rational and is tied to the actual savings. With Korsuva, there's not gonna be anything there. The third thing we're gonna be looking for is for clarity after the third year, because, again, a drug like Korsuva, there is, there is no money in the bundle and what happens afterwards. We're gonna be seeking clarity on that. The other thing that we're gonna be pushing CMS on and having a discussion about is making sure that there is a TDAPA period for Korsuva, that allows the community to use the product in the same. Knowing what the reimbursement and funding mechanism after the TDAPA period ends. Right now, the product is being used in a context where there isn't any. The thought is there would be no money added. We're gonna be trying to get the extra TDAPA period to try to make sure that there's good data that appropriately lines up to the patient access. Got it. Thank you so much. Thank you. Our next question comes from the line of Annabel Samimi of Stifel. Hi, thanks for taking my question. I had a few, actually. Just while we're talking about CMS, I guess a couple of things. I guess first, I guess we understand the Parsabiv also got an extra year of TDAPA payment. I was just wondering if you can outline what similarities or differences you might have had with Parsabiv, given that's the pretty much the only other drug that's gone through this, and how they got that additional year? Then if Korsuva stays within the bundle the way that they've described, with this structure, do you envision incentives for dialysis providers to not use the drug and just collect the payments, as they might have done for Parsabiv? Just wanted to understand the dynamic that we might see, post-TDAPA. I might have another follow-up. Thanks. Yeah. All right, Annabel, I think let me unpack. The first one is around extending to our TDAPA period and the rationale why and why that is the same or different than Parsabiv. Let me, let me give that to Scott, and I may have a couple words after. Yeah, sure. With regard to Parsabiv, it, it's not a great analog in one sense because the, Parsabiv, obviously, there was a, an oral generic that was used afterwards. There is one similarity with regard to why it would-. make sense and be consistent. With Parsabiv, CMS was looking to get accurate information to understand how much weight to add to the bundle. That's the same argument we're going to make, that at the end of the day, we don't believe that the utilization and the uptake is gonna be accurate in an environment where there would be new money added at the end of the TDAPA period. We think the precedent there with that regard, which is get better data, is consistent with Parsabiv. Yeah, Annabel, I think on your second question, hopefully, I got it right. Basically, if I understood the question right, the proposed methodology from CMS could suggest a reverse incentive, meaning that some of the dialysis organizations would be incentivized just to pocket the additional money and not use Korsuva. You know, I'll say a couple of things. I mean, one is, it's certainly, you know, they could do that. You know, our belief is that, that will not happen. You know, dialysis organizations are very much used to working in the capitated environment, meaning they're gonna lose some money on some patients and, and make some money on others. We, we remain pretty confident that the appropriate patients will continue to have access to Korsuva. You know, listen, we all have the same North Star around patients being at the center. Our kind of what we could control here at Cara, and what we're really focused on, is making sure that there is adequate and accurate funding, so patients are gonna have access to this drug. That's what, you know, Scott alluded to in his earlier comments, and that's really our focus. I guess also, just to be clear, the, the payment also is recalculated every year, correct? So if utilization- Correct. goes down, that's gonna go down. Well, technically, based on their proposal, that could, could happen, correct. It would be calculated on an annual basis. Okay. Then just to switch gears for a bit, would you say that the reorder rate for, DaVita, their independent, dialysis provider, is 70%, is that about where you would expect, reorder rates to be in a formalized environment for, say, Fresenius, when the, when the, Mm-hmm. inventories, wash out? Yeah, I would. I mean, we, we've seen it pretty consistent, you know, in that 70%. I mean, DaVita is actually this month or this quarter was, or Q2, sorry, was 73%. It's interesting, if you look at USRC, which is the largest of the MDOs, they're about an 80% reorder. But I think we feel pretty comfortable that you're gonna be in the range in that 70% reorder rate. We've seen that pretty consistently, really since the, the launch. And I, I've been really pleased, and Annabel, we've talked before. I've been incredibly pleased with that reorder rate. We don't get patient-level data. We do look at reorder rates as a, a proxy for, you know, call it a, a really good patient experience. And we see this consistent month-to-month reordering by clinics that have started dosing patients. Okay, great. If I could just squeeze in one more. I did notice that you, you expected, Fresenius to be reordering by the end of the year. Has that changed from your expectation of seeing normalized inventories by mid-year? I would say we, we've always expected, I mean, we're looking at the growth trends on the quarter-to-quarter basis, and we saw a 48% increase in the number of clinics now exhausting their initial stock from Q3 and reordering. That's, you know, roughly 720 clinics. You know, if you, if you see that growth continue, we would expect the majority of these clinics to have exhausted their inventory and reorder. Again, you know, with the 70%+ reorder rate that we would fully expect from percentage once they kinda normalize with that, I mean, it, it, it really forms a nice growth annuity as more and more patients, you know, kinda get this product. We haven't come off of that. We're just kind of analyzing our growth rate and seeing, you know, if this continues, you know, we, we feel pretty good about, about the majority of these clinics in the second half of the year exhausting their stock. Okay, great. Thank you. You're welcome. Thank you. Our next question comes from the line of Joseph Stringer of Needham & Company. Hi, thanks for taking our question. Now that you're a couple of quarters into the launch, how are you thinking about potential monetization of the IV Korsuva revenue stream, and what are some of the gives and takes that go into that decision? Hey, Joey. If you are referring to the ex-US royalty revenue, I think, you know, we, we haven't really been terribly specific about what we plan to do from a financing perspective on the non-dilutive front. I mean, maybe, Ryan, you wanna say a couple of words on that? Yeah, Joe, was that your question? Was it related to ex-US, or were you talking about the US revenue stream? If you could comment on, both, that, that'd be helpful. Yeah, I will. Let me take one off the table. On the U.S., that wasn't our focus. You know, we're from a U.S. perspective, and we get 46% of net sales, essentially. We're really in the initial quarters of this launch. And we feel there's pretty significant upside. Now, we'll have to see how CMS works itself out over the next couple of months. Where our focus has been from a financing side, you know, Ryan, maybe you can comment. Yeah on the ex-U.S. I think we are in a good position where we do actually have an asset that is generating cash, and this is ex-US. We've discussed in Chris's prepared remarks how well Europe is doing and how both CSL and ourselves are very excited about the potential for Europe going forward. We are looking at opportunities to potentially monetize that. We also discussed the potential approval of Japan in the second half of the year. That's also another potential cash-generating asset. We've got a lot of options, and we're hopeful that we can execute on those. Okay, great. Thanks for taking our question. Thanks, Joey. Thank you. Our next question comes from the line of Sumant Kulkarni of Canaccord Genuity. Good afternoon, thanks for taking our questions. I, I have a few here. At what point will you or your partner have a better handle on steady-state utilization of Korsuva IV, so you get the best possible reimbursement rates post TDAPA? Or how long do you think it would take to get to that rate? Sumant, you know, it's a tough question because, you know, really, you know, we're, we're working with one payer, essentially, right? CMS are the dominant payer in the-- in this ecosystem, in dialysis. Understanding the funding is gonna be really critical. That will determine the future trajectory of this drug. When the final rule will be, you know, sometime later this year, we're in the 60-day comment period. I think Scott summed it up nice, Sumant. I mean, you know, we found the proposed rule. There's some positives there, right? I mean, they are adding additional funding, and that's certainly a positive. We're certainly moving the needle with CMS to provide access to innovation and, and properly fund it. You know, we do have some serious concerns around the reimbursement methodology that Scott very clearly outlined, that, that would have an impact on funding and potentially could be a headwind for us. I, I would say, you know, Sumant, it's, it's a little too early to talk about the trajectory until we fully understand, fully understand the CMS final rule and what that could mean from a funding standpoint long term. I mean, one thing that's really crystal clear to us is that there is a significant unmet need, and this drug is, is very effective, and, and it actually makes a big difference in patients' lives. As I said before, you know, patients at the center of everything we do, I know I can speak for my partner there, CSL Vifor with regard to Korsuva. Our focus during this comment period is really on addressing some of these reimbursement concerns around the proposed rule that they outlined, but also, importantly, as Scott said, requesting an extension of the TDAPA period. We do know TDAPA's had has challenged some of the uptake with some physicians. As, you know, listen, I mean, their experience is with Parsabiv, and they're a little nervous that if they start patients on Korsuva, they may have to stop them if funding is not available. We're really focused on this over these next, I would say, 60 days till CMS publishes their final rule. Got it. Given the relative difficulty of figuring out an optimal utilization rate, what do you think an optimal number of years of extension of TDAPA would you be asking for, and when would you expect to get more clarity on that, given CMS is already running a process? Sure. Let me, let me give that to Scott to talk about our plan with the extension. Yeah. Again, we think we have a strong argument that we should get a new TDAPA period, which is essentially 2 years, because we need to have a amount of time where they can get the full ability to, to manage the utilization and get the right patient access based on what the funding is gonna be. With regard to when we would hear, we expect there's not a specific rule for how that would happen, but we would expect to hear and we would ask to hear in the November final rule what the plan was. Got it. Thanks. Thanks, Sumant. Thank you. Please stand by for our next question. Our next question comes from the line of David Amsellem of Piper Sandler. Hey, thanks. I, I, I apologize if I, if I missed any, any color here. As, as you think about the cash runway and, and the upcoming clinical milestones, can, can you talk about how you're thinking about oral DFK strategically in terms of, you know, whether this is something you'd look to monetize in some way, or, or keep it and, and commercialize it? I'm just trying to get a better sense of, you know, how you're thinking about the asset, just given the cash runway and resource constraints. Thanks. Hi, David, this is Ryan. I'll, I'll start out and, and kind of give some color on, on our investment in oral difelikefalin, and then I'll pass it over to Chris to talk more about the long-term strategy for it. The good news is that we can fully fund difelikefalin in these three late-stage programs, and that's critical, and that's what we actually are working on here at Cara Therapeutics. You know, obviously, CSL is running the launch for Korsuva, but where we are spending our money, our investment is on these three programs. In the guidance I gave you, those three programs, atopic dermatitis, chronic kidney disease, and notalgia paresthetica are fully funded. I'll pass it to Chris now to talk about- how we think about it? Yeah, David, I mean, we, we still remain very focused on developing these two franchises. You know, from a commercialization standpoint, you know, we, we've been very public in saying we, we would certainly look. We, we would look for ex-US partners. We, we do not have an intention right now of commercializing ex-US. I would remind you, and, and I know you know this, that, you know, we own the rights to oral difelikefalin outright. We would certainly look outside the US for a partner. In the US, you know, our intention is to stand up a commercial organization to maximize the potential of these products and do it alone. Okay, that's helpful. If I may sneak in one more, this is unrelated... Sure. on, on Europe. Mm-hmm. just remind us what pricing for the drug is. Obviously, it varies market to market, but how should we think about pricing in Europe, in the big, in the big markets, at least relative to the US? Yeah, I mean, David, you're, you're right. I mean, it, it varies market to market. What I can tell you, in Germany, for example, the price per vial, I believe, is around EUR 48 per vial. You know, kind of a third of what we have in the US, it's probably a good way to think about it. I think, I think, you know, where we're really encouraged in Europe is, you know, the patient population in the EU5 predominantly, is, is not that dissimilar to the US. We're seeing, you know, Ryan alluded to it earlier, we're seeing pretty good uptake or very good uptake actually, since we launched in Germany in the Q4 last year, in terms of both growth and patient sales. We're actually really encouraged what we're seeing. You know, reimbursement is very different. You don't have a TDAPA sort of system or a cliff, so to speak, on TDAPA. You know, CSL's got a very good commercial footprint, executing really nicely. Okay, that's helpful. Thank you. Thanks, David. Thank you. Again, to ask a question, please press star one, one on your telephone. Again, that's star one, one on your telephone to ask a question. Our next question comes from the line of Jason Gerberry of Bank of America Securities. Hey, this is Qi on for Jason. Thanks for taking the questions. I, I guess, you know, regarding a comment about you expect to hear back from CMS on any update or change to the proposal in the final ruling sometime this fall/winter. Can you remind us, sort of like, if you do get the -- if you do or do not get the additional, the TDAPA, can you help us understand, say, you know, if you do not get the additional TDAPA, how do you think about consensus estimate doubling the sales in 2024 versus 2023? What I'm trying to get at is, if the reimbursement mechanism is such that the CMS will look at the prior year utilizations, apply a 35% haircut to it. Oh, I'm just trying to understand, do dialysis centers just simply have to give up, you know, other treatments in order to make way for volume? I'm just trying to get a sense of sort of the, you know, the disconnect between what some consensus is forecasting versus the CMS proposal. Well- To the extent that you can provide that color, that would be great, and then a follow-up after that. Sure, Qi. I, I won't comment on consensus necessarily, I think your, your analysis on how this works within a capitated system is correct. If nothing's changed, you know, the onus is on the dialysis facilities to fund the product and actually compensate for it by looking at other avenues within that bundled rate. You know, what we expect, Well, what I'd say what we're doing, is obviously working with CMS now in the, in this comment period, and Scott mentioned earlier, around voicing our concerns with the reimbursement methodology. You know, we have some concerns around how they're gonna calculate the additional funding, let's be clear, there is gonna be additional funding added to the bundle in their proposed rule. You know, when we kind of understand where CMS is gonna land with that, as well as the extra TDAPA period that Scott mentioned, you know, we'll have a better sense of the trajectory of this drug based on the ability of dialysis facilities to resource it. That'll, that'll be critical, and that will determine, you know, kind of the future of this drug. Again, we're encouraged that encouraged, I would say we're confident that we have a strong case for additional TDAPA time that Scott mentioned. We're certainly not gonna handicap that at this point. I mean, we are, we are working closely with CMS, or at least providing comments to them, and we'll engage with them during this period of time. Mm-hmm. Help me, maybe help me understand, here. You have a 60-day comment period, and then you have this proposal coming out sometime in October, November. Is that sort of like a two-way dialogue between you and CMS, or is it sort of more like you submit the comment, and you won't hear back anything until October, November timeframe? Just help us think about sort of the. Sure ... the level of visibility you have between now and, you know, when the final proposal comes out. Sure. Let me give it to Scott. Yeah, as you said, we'll be providing comments during the 60-day period. We will engage with CMS to provide more information. We would not expect to get anything back from them before the rule. You know, they're in a comment period. They have rules they have to follow. We wouldn't expect there'd be any information back directly to us, or certainly publicly, before that November rule came out. Okay, maybe just one last one from me. Can you talk about, remind us sort of the, the connection between the manufacturing supply revenue on Korsuva and the, the, the revenue recognitions of IV Korsuva? It looks like the manufacturing supply revenue looks a lot light this quarter. Yeah. Sequential increase in the revenue. Is it just the nature of lumpiness, or does it like, sort of like, is it, is it any way a leading, indicator of sort of like how much, you know, IV Korsuva people will order from Cara? Chi, this is Ryan. Thanks for your question. I would start by saying they're, they're really disconnected in the short term. The commercial supply revenue is basically us shipping vials to Vifor based on the release from quality, 'cause we're basically acting as the manufacturing CRO for Vifor, as we get vials released from quality, we ship them immediately to Vifor under a PO. There's no connection to short-term demand. As you know, the IV Korsuva revenue is based on shipments from Vifor to the wholesalers, and that's how we recognize revenue. You're correct in the sense that this shipment of commercial supply revenue was down from the prior quarter, but that was simply based on the QA releases we get from our provider. Okay, great. Thanks for answering the questions. Thanks, Chi. No problem. Thank you. I would now like to turn the conference back to Christopher Posner for closing remarks. Sir? Thank you, Latif. Well, thanks everyone for joining us today, and I just wish everybody a great afternoon. With that, I'll end the call. This concludes today's conference call. Thank you for participating. 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