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spk11: Good afternoon. My name is May and I will be your conference facilitator. I would like to welcome everyone to CARA Therapeutics first quarter 2022 financial results and update conference call. All lines have been placed in mute to avoid any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star and the number one on your telephone keypad. If you would like to withdraw your question, press the pound on your telephone keypad. Please be advised that this call is being recorded. I would now like to introduce Iris Francesconi, Interim Head of Investor Relations from Kara Therapeutics. Ms. Francesconi, you may begin the call.
spk02: Thank you, May, and good afternoon. Just after markets closed today, we issued a press release detailing our corporate progress and financial results for the first quarter of 2022. The press release can be found on our website at www.careoftherapeutics.com. You may also listen to a live webcast and replay of today's call on the investor section of the website. Participating in today's call are Chris Hosner, CARES President and Chief Executive Officer. Tom Riley, CARES Chief Financial Officer, and Dr. Joanna Goncalves, CARES Chief Medical Officer. Before we begin, let me remind you that statements made on today's call regarding matters that are not historical facts are forward-looking statements within the meaning of the Private Securities Mitigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the company's ability to successfully commercialize procedure injection and Capudia, including the timing of product launches, planned future regulatory submissions, and potential future regulatory approvals, the company's ability to obtain and maintain coverage and adequate reimbursement for procedure injection, the performance of our commercial partners, including B4 Pharma, expected timing of the initiation of enrollment and data readouts, from the company's plans and ongoing clinical trials, the potential results of ongoing clinical trials, timing of future regulatory and development milestones for the company's product candidates, the potential for the company's product candidates to be alternatives in the therapeutic areas investigated, the size and growth of the potential markets for pruritus management, the company's expected cash rates and the potential impact of COVID-19, and the company's commercial launches clinical development, and regulatory timelines and plans. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied for such forward-looking statements. Risks are described more fully in care of therapeutic silence with the Securities and Exchange Commission, including the risk factors section of the company's annual report on Form 10-K for the year ending December 31st, 2021. and its other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in today's call speak only as of the date on which they were made. Care Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. With this, I will now turn the call over to Chris.
spk04: Thanks, Iris, and good afternoon, everyone. The first quarter was pivotal for Kara, as we are now a commercial stage company, moving our growth story forward. The first few weeks of Corsuba Injections US launch have proceeded as planned, and all of our programs, many of which we have recently detailed to you, remain on track. I will give some highlights on our encouraging progress in a moment. Tom will follow with the financial update, and after that, we will be available to take your questions. Kera Therapeutics has a unique mission, focus and value proposition. We are building the world leader in pruritus. We see this as a differentiated value proposition and opportunity. Chronic pruritus is often a severe, intractable problem for patients in a wide range of diseases, and it is underserved by currently used treatments. This quarter, we continue to execute on our three strategic priorities which we believe will put CARA on a firm path to sustainable growth. Of course, our first priority is to maximize the commercial potential of Corsuba injection. We are now in full launch mode in the U.S. As you will recall, the commercialization efforts in the U.S. are being led by our partner, V4 Pharma, a leading renal pharmaceutical company in the U.S. Now, we are still at a very early stage of the launch, so what we will share with you today is largely qualitative. Beginning in Q2, we will provide more quantitative data, which will paint a more detailed picture. Now, our primary objectives in the first four weeks of launch were to, A, have products shipped to wholesalers, B, have contract negotiations underway with the top dialysis organizations, C, Have DO systems updated with product pricing and reimbursement information to allow product ordering. D, pivot the sales force from disease awareness and patient identification to promoting course of injection. And E, enhance patient awareness to help steepen the launch trajectory. Now, I am pleased to report we are tracking to our expectations and are seeing very encouraging progress across all of these goals. Let me elaborate. First, course of injection is available to be ordered by dialysis clinics nationwide. The V4 team has been working diligently to ensure that the product pricing and reimbursement information is loaded into the respective systems so that orders can be placed. That means a physician can prescribe it to a patient when they are identified as a candidate for the product. And remember, Korsuga injection reimbursement is in place via Medicare and need to DAPA qualification. Now, V4 has shipped product to wholesalers, and wholesalers have started to ship product to dialysis clinics. I am pleased to report that patients have received commercial product at this point. Second, nephrologists are aware of Korsuga injection and ready and starting to prescribe. Since the launch meetings in March, the V4 sales force has transitioned from patient identification to product promotion. They are promoting course of injection to physicians, advanced practice providers, and nurses. And I am pleased to report that they have reached the majority of HCPs at least once in the past four weeks. Now, anecdotally, palpable excitement is also evident within the nephrology community around the introduction of this new breakthrough first-in-class product. After the National Kidney Foundation meeting in March, one nephrologist wrote that pursued injection is poised to change the treatment of uremic pruritus. And feedback from the field ride suggests similar tangible interest in this product. Third, patient outreach is expanding through new channels. Significant efforts have already been underway to raise patient awareness for pruritus and hemodialysis. And as you know, patients can be key drivers of demand for a product like Coursive Injection. The latest activity is the first large-scale education and awareness campaign on pruritus with chronic kidney diseases by the American Kidney Fund with support from BFOR. Now, the payoff to all this work is that patients finally can receive a treatment for a longstanding unmet need. And I'd like to remind you that this is an underreported, underserved patient population. We are confident that the addressable market is about 40% of the total hemodialysis patients. This is a baseline of roughly 200,000 U.S. hemodialysis patients with moderate to severe pruritus associated with chronic kidney disease. They are looking for answers, and our product can provide one. Looking ahead, in the second quarter, we expect to share more quantitative metrics for you to track our progress. We will disclose net sales of course of injection, as well as CARES revenue of the profit share. We will also update you on the units shipped from wholesalers to dialysis clinics. This is a really good proxy for end user demand, since dialysis clinics do not carry much inventory. Now turning to markets outside the U.S., the opportunity in Europe is squarely in our sights. Capruvia is now the first therapy available in Europe for the treatment of pruritus in hemodialysis patients. On April 28th, we announced Capruvia was approved by the European Commission. The U.K. followed with its approval the next day. As we mentioned before, the EU approval triggered a $15 million cash milestone payment from our ex-U.S. partner, V4 Percentius Medical Care Renal Pharma. This payment adds even more strength to our balance sheet. We expect the launch of Capruvia by our partner in the EU to commence in the second half of 2022. Stay tuned. Now let's turn to our second strategic priority of advancing our oral Coursula Phase III pruritus programs for non-dialysis-dependent advanced chronic kidney disease and atopic dermatitis. These pivotal Phase III oral programs have started and are moving forward as anticipated. Now, just to remind you, these programs address significant markets. In the U.S., about 400,000 patients have moderate to severe pruritus with advanced kidney disease. in atopic dermatitis, about 12 million patients suffer from pruritus. Now, we believe we have the right programs to capitalize on these opportunities. There are no FDA-approved therapies for pruritus in either disease area, and currently used treatments have been insufficient. As you recall, our third strategic priority is to expand the clinical utility of oral Coursiva in other therapeutic areas, including Natalya Parasetica, and chronic liver disease. And our next catalyst is approaching quickly. The phase two proof of concept trial for Natalya Parasetica is on track to report top line data in the second quarter. This trial is looking for an efficacy signal to establish a proof of concept clinical benefit in treating pruritus in Natalya Parasetica. We will use this data to inform the development path in this indication. In addition, the Phase II data readout in primary biliary cholangitis associative pruritus remains on schedule for the second half of this year. Simply put, our pipeline is progressing well. Our approved product is starting to reach patients, so we are accelerating to full-scale ACARA. Now I'd like to turn the call over to Tom for details on our first quarter results. Over to you, Tom.
spk03: Thank you, Chris. As a reminder, the full financial results for the first quarter of 2022 can be found in our press release issued today after the market closed. Cash, cash equivalents, and marketable securities at March 31st, 2022 totaled $209.6 million compared to $236.8 million at December 31st, 2021. The decrease in the balance primarily resulted in 25.5 million of cash used in operating activities. For the first quarter of 2022, net loss was 27.7 million or 52 cents per basic and diluted share compared to a net loss of 23.3 million or 47 cents per basic and diluted share for the same period in 2021. Total revenue was $4.8 million for the first quarter of 2022 compared to $1.9 million during the same period of 2021. The $4.8 million in Q1 2022 related to consumer injection commercial supply to V4 Pharma. In Q1 2021, the $1.9 million related to licensed revenue earned from Mariuchi Pharmaceutical Company in the first initiation of a Phase III trial for uremic pruritus in Japan. In February 2022, the company had not recorded any cost of goods sold related to its commercial supply revenue, as all inventory costs were incurred prior to receipt of regulatory approval of Cursiva injection, and accordingly were expensed as incurred. In March 2022, the company recorded commercial supply revenue of $2.5 million with associated cost of goods sold of $2.1 million, as these inventory costs were incurred subsequent to the receipt of the regulatory approval for superinjection. R&D expenses were $21.3 million for the three months ended March 31, 2022, compared to $19.1 million in the same period of 2021. The higher R&D expenses in 2022 were principally due to increases in direct clinical trial costs and payroll-related costs. G&A expenses were $9.3 million for the three months ended March 31, 2022, compared to $6.4 million in the same period of 2021. The higher G&A expenses in 2022 were principally due to an increase in stock-based compensation expense, which includes an additional $1.6 million compensation expense related to the modification of the company's former chief executive officer's equity awards in 2021, as well as an increase in payroll-related costs. Based on timing, expectation, and projected costs for current clinical development plans, CARA expects that its existing unrestricted cash and cash equivalents are available for marketable securities as of March 31, 2022, including the $15 million regulatory milestone payment earned in April 2022 upon European Commission approval of Coprobia will be sufficient to fund its currently anticipated operating expenses and capital requirements into the first half of 2024 without affecting any potential milestone payments under existing collaborations or product revenue in the commercialization of procedure injection. With that, I will now turn the call back over to Chris.
spk04: Thanks, Tom. In summary, we are optimistic with the start of this year. Our continued execution propels us down the road of significant value creation. The launch of course of injection is progressing well. We set our expectations and met them. A, the product can be ordered by all dialysis organizations. Two, reimbursement is in place. Three, physicians know the benefit of the product and they're starting to prescribe. And lastly, patients are starting to receive course of injection. In the EU and UK, Caprovia is now approved, providing a second significant market opportunity. The EU rollout is expected to start in the second half of 2022. And the associated milestone payment of $15 million extends our cash runway into the first half of 2024. And we are executing to deliver on our pipeline. The oral programs have potential to create a platform product with a much broader market opportunity across many diseases. Pivotal phase three programs in AD and advanced CKD are underway. The phase two proof of concept data in Nortalgia parasitica is expected in the second quarter. Our PBC phase two data remain on track for the second half of 2022. Now, our strategy is to be the leader in bringing new treatments for pruritus to market, an under-realized opportunity of millions of patients. We have taken important steps this quarter to make this happen. Now, with that, Tom, Joe, and I will be happy to take your questions. Operator, over to you to open the call up for questions.
spk11: As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Your first question comes from the line of Joseph Stringer from Needham & Company. Your line is open.
spk09: Hi, good afternoon. Thanks for taking our questions. Two questions from us. The first one is on IV Corsuva. You mentioned that the addressable patient population, you mentioned that 40% or so of dialysis patients with moderate or severe pruritus. I'm just wondering if you could provide some additional color on maybe what those 40% is. You know, there are patients that you believe that you can reach first initially with the drug. Is it sort of tiered on sort of level of, you know, response to itch or any additional thoughts on, you know, how you think about those in terms of the initial patients for IV Cursuva and then sort of working your way up the tier to get more patients.
spk04: Yeah, Joey, nice to hear from you. Certainly. So if you look at the literature, we see roughly 65% of patients kind of human dialysis patients in the U.S. suffer from some form of itch. And again, in the literature, about 40% suffer from moderate to severe varitis that are undergoing dialysis. And you kind of triangulate that now in practice in the real world. And we're hearing very similar numbers in terms of the addressable population. So the 40%, Joey, is really what we view as the addressable market. There's roughly... 500,000 patients undergoing dialysis in the U.S., and about 200,000 of them suffer from kind of this moderate to severe form of pruritus that would be a candidate for course of injection. And, you know, I just add, Joey, I mean, the nephrologists agree that this is really a significantly underdiagnosed condition among patients, and that's really due to a lack of effective treatment options. And the majority of nephrologists that we talked to, we're hearing it from the field as well, say that they're going to actively start to identify these patients now that they realize that there is a solution available. So we feel pretty darn good about that number.
spk09: Okay, great. Thanks for taking our question.
spk04: You got it, Joe.
spk11: Your next question comes from the line of Jason Dearberry from Bank of America. Your line is open.
spk07: Oh, hey, good afternoon. Good evening. This is Chi for Jason. Thanks for taking our question. Maybe just a quick one. I think there's, you know, we've been getting questions of sort of like expectation for second quarter, which is going to be the first quarter of, you know, CARA will report net sales and royalty contribution and whatnot. So I'm hoping you can provide some color in terms of, you know, sort of what is the one-timer, what do you expect from manufacturing fee, and what do you expect from, you know, sort of the accounting purpose, sort of like if you can lay it out for us. I think, you know, there's going to be a $15 million milestone expected from, you know, you expect to receive from the approval, how are you going to recognize that, you know, from a resume perspective. And then the rest of it, is it going to be from the underlying domain of IE Korsuba launched in the US? And then, you know, hoping you can provide some color, you know, you recognize a commercial supply revenue of about $4.8 million in the first quarter. Is this sort of the manufacturing fee that, you know, you're continuing to use as a recurring item? You know, just think about, you know, from a sales and modeling perspective, should we keep, you know, is that going to be a separate item? Is it going to be a recurring item? you know, separate from the revenue contribution of Ivy Coursera. So if you can sort of help us understand the different components for second quarter, that would be helpful.
spk04: No, no doubt. So, Chi, I mean, let me first, I'll turn to Tom for some of the accounting on the P&L and how we're going to account for that. But what I would stress is what we intend, I mentioned some qualitative things around the early days of the launch. Q2, we will obviously provide much more quantitative metrics and The three metrics that we're committed to provide just to reinforce this is, you know, one, total net IV Corsuba sales. Two will be Karen's IV Corsuba's revenue. And then the third, which I think is really important because it gives transparency on demand generation, that's going to be aggregate wholesaler sales volume to customers. And we do believe this is a really good proxy for end-user demand as I mentioned before, dialysis centers don't carry a lot of inventory. So I just want to be clear, those are the three metrics that we'll track consistently quarter to quarter beginning in 2Q. Let me turn it to Tom from a P&L accounting standpoint. Hopefully you get those questions from Chad.
spk03: Yeah, sure. Thanks, Chris. So the question was more on the transparency related to revenue and in particular on the commercial supply. So related to... The first one, the $15 million milestone, that'll be separated out. That is part of our license and milestone P&L line item, so that'll be separated out. As Chris just mentioned, for transparency perspective, we will be showing on our P&L the profit split revenue, which also will be in a separate P&L line, and then we'll be disclosing pursuer injection net sales, so you'll be able to see the comparison of the profit split And I think the third question, Chief, I got it right, was related to commercial supply revenue. And so the commercial supply revenue will also be broken out separately. And you had mentioned more forecasting and modeling purposes. So that's related to supply that we ship over to our partner V4. And so as the product demand starts building, we will be sending products to before commercial supply to sell to the channel. So that will be transparent in our P&L on a revenue line item, and the associated cost of goods sold that you'll see will be associated with that commercial supply P&L line. So you'll see from our disclosures in this quarter the transparency between what was actually incurred with the relative cost of goods sold starting in March versus anything that was expensed prior. So hopefully that answers all of your questions.
spk07: No, this is for Kalia. Thanks so much. We were getting some questions, and we are aware that consensus is sort of less body, and just hoping to sort of, like, get some clarity, hoping that, you know, we will have, you know, less body numbers looking at second quarter. So thanks so much for the help. And that's it. Look forward to hosting you guys at our conference this week.
spk04: Yeah, looking forward to it.
spk07: Thanks, too. Thank you.
spk11: Your next question comes from the line of Daniel Wolley from JP Morgan. Your line is open.
spk01: Good afternoon, guys. Thanks for taking our question. A couple from me. First, with a little bit of over one month of commercial launch behind us, what can you tell us about the initial activities that would indicate that significant uptake is still an expectation for Cursiva injection? I have a follow-up.
spk04: Yeah, Daniel, I'll tackle the first one. So here, let me just tell you specifically, you know, the first couple weeks of the launch, you know, I mean, A, the V4 team has really worked diligently to ensure that the product pricing and reimbursement information is loaded into the systems so orders can be placed. And, you know, V4 has shipped product to wholesalers, and wholesalers have started to ship product to dialysis clinics. So most importantly, patients are receiving commercial product. And then the second thing, you know, around execution. I mean, since the launch meetings in March, the V4 sales force has transitioned from patient identification to product promotion. And they are promoting course of injection to physicians and advanced practice providers and nurses. And I'm really pleased to report that they have actually reached the majority of these ACPs at least once in the past four weeks. And anecdotally, I mentioned before my prepared remarks, there's a high level of excitement, a high level of excitement. And then lastly, you know, they really upped the efforts in terms of activating and engaging patients. You know, we believe, both V4N Care believe that the patients are key drivers of demand. So, you know, a lot of activity around activating patients, and I mentioned again in my prepared remarks, a campaign that they just launched with the American Kidney Fund with support from V4. So, you know, from my standpoint, what we're seeing in the marketplace is quite encouraging. You know, there's a lot of excitement around the product. We're seeing ordering, and we obviously expect that to accelerate, you know, in the coming weeks.
spk01: Okay, great. And in terms of activating and engaging these patients, is it possible for you to quantify for us the potential contribution to the addressable patient population that can be driven by raising this patient awareness?
spk04: Well, it's hard to quantify at this stage, but I can tell you it's a multi-pronged demand generation program. Obviously, bottoms up working with nephrologists, advanced practitioners, as well as nurses and the patients, and at the top-down approach, working with the dialysis organizations. So the V4 team, it's hard to put a number on the list, kind of value creation of each of those. But the V4 team has done a very nice job leaving no stone unturned in their marketing efforts. That's what I can tell you.
spk01: Okay, great. And then on the European launch, can you provide us some color on how we should think about that launch for Capruvia, the reimbursement dynamics across different countries, and then the economics involved with the JV?
spk04: Yeah, so Tom tackled the JV question, if you allow me, Daniel, but let me talk a little bit about Europe. Again, early days, I mean, the great thing, A, is we have an approved product called Coprovia, and we announced April 28th via the European Commission. And overall, if you look at the opportunity in Europe, you're looking at about 300,000 patients undergoing dialysis in Europe, and we're hearing kind of a similar sort of, prevalence for an addressable population, around 40% of that population would be addressable for a drug like Cupruvia. And I'd be remiss, and I have my chief medical officer sitting next to me, I'd be remiss not to tell you that there's a tremendous unmet need in no-proof therapies for these patients in Europe. So that's A. In terms of how, you know, what we've guided to with V4 is that Launch will occur sequentially with countries beginning in the second half of 2022. Germany is traditionally the first country to launch in Europe. It will be no different for Caprivia. And reimbursement is different. Europe is not one country, so reimbursement is different across the different countries. But again, in terms of sequence of launch, Germany will go first in the second half of this year. and then the rest of the Western European countries will follow suit in the 2023. So we're quite excited about the opportunity in Europe. You know, again, similar dynamics in the U.S. in terms of high unmet need, no approved therapies, and, you know, the VPOR team has really done a good job preparing the market. It's not like, well, they've been preparing the European market really at the same time they've been working the U.S. market. So we're quite excited about the potential there. In terms of the JV, Tom, maybe you could just talk to Daniel about the JV real quick.
spk03: Sure, no problem. So Daniel, as we mentioned earlier, there will be a $15 million, and it's a cash milestone, which we'll receive based on the approval. Related to the economics, it's your traditional royalty-based agreement outside of the U.S., or it's based off of net sales? Yes. So it's the royalty, the tiered double-digit royalty structure based off of net sales outside of the U.S.
spk01: Great. Thank you very much. Thanks, Daniel.
spk11: Your next question comes from the line of David Amsalem from Piper Sandler. Your line is open.
spk08: Hey, thanks. I joined late, so I apologize if I missed. these topics. But just on the launch, can you just talk about who you think are the ideal initial patients, if you will? Or maybe I'll ask a different way. Can you just talk about, you know, where is sort of the low-hanging fruit in terms of, you know, patients? Is it those who have already, you know, been on, say, oral antihistamines or gabapentinoids or You know, how is your partner thinking about that? That's number one. And then number two, can you just talk about pricing in Europe and how you think it's going to shake out relative to the U.S., I mean, to DAPA and the bundle notwithstanding, but at least initially, how do you think that will shake out? Thanks.
spk04: Yeah, David, nice to hear from you. Let me tackle the last question because it's a bit more straightforward. The price in Europe, obviously, we just got an approval. V4 will work on pricing in the European countries with the government committees over the course of the next X number of months. In terms of the expectation, I would tell you obviously it's going to be lower than the U.S. in general. To the degree and magnitude of how much lower, we don't know yet. I think that's work to be done by the V4 team with the value proposition, again, with the authorities in the European countries. Your first question is a really interesting one on patient segmentation. And again, there's been a lot of market research and a lot of work done by the V4 team and the care team on patient segmentation. You know, there are a lot of patients that have basically tried and simply resigned for the fact that there's no great treatment alternatives. So, you know, we really believe that activating these patients to tell their nephrologist and their nursing staff that there's a solution now available, we believe that they are low-hanging fruit. And what we're hearing in the marketplace is that once, you know, it's kind of like the marketing adage of magnify the problem, own the solution. You know, really, you know, talking about the solution with these patients they've been very active now engaging with their nephrologists. So I think, you know, instead of getting into individual segmentation, you know, that's what we believe, you know, really is the patient population that will be the initial patients to get on drugs.
spk08: Hey, that's helpful. Thanks.
spk04: You got it, David.
spk11: Again, to ask a question, please press star 1 on your telephone keypad. Again, that is star 1 on your telephone keypad. Your next question comes from the line of Annabelle Samimi from Stifo. Your line is open.
spk12: Hi, this is Stacey calling in for Annabelle. Congratulations on all the development, and thanks for taking our question. The Natalja Parasetica proof of concept data is coming up soon. Will this be reported out in a similar fashion as the base to atopic dermatitis, and will Is there any benchmark for Natalja that we should be thinking about? You know, what are some of the in terms of placebo and what you need to see over placebo to reach particular significance? And if successful, will you be pursuing any safety programs or use the data strictly to establish activity in neuropathic itch? And the second question is, do you expect R&D expenses to increase throughout the quarter or stay in the similar range as this quarter? Thank you so much.
spk04: You got it. I'll have Tom tackle the second one if you allow me, but let me turn it to Dr. Gonsalves, who will answer the metastatic parasite question.
spk10: So thank you for your question. So to tackle the first part of it, we will be sharing the data as we typically have done on the top nine results. for the study in this quarter, quarter two. You were asking about benchmarks within the soldier parasitica. Up to date, there has not been any robust placebo-controlled study to be able to glean on what the placebo response would behave like, so we will wait for our data. and wait to see what the placebo will look like. But there's really not been anything, and this speaks to the unmet need of Natalta parasitica, that very little research, actually no research has really been done in this space. So we look forward to our data. And then you will ask people expectations of the data in the next step. As a small group of context studies, We are expecting to see a numerical separation from placebo. What we also would like to see is a consistent pattern of efficacy as we have seen across all other disease areas. So a fast onset of action and sustained out to the eight weeks. We'll wait for the data and review it comprehensively and then take it from there on what the next steps will be in the development plan.
spk04: Great. And on the R&D expenses, Tom, maybe you just speak to that.
spk03: Yeah, sure. So we don't guide on R&D expenses on a quarter-by-quarter basis. So what I would suggest or what I would recommend is we did provide guidance today related to our cash runway, which will carry ongoing operating expenses and development expenses into the first half of 2024. And that does not take into consideration any revenue associated with cursiva injection. So I think from that perspective, that should help you get a sense of what we're expecting from a cash burn over into the first half of 2024. Awesome. Thank you.
spk12: Very helpful.
spk03: Thank you. You're welcome.
spk11: Your next question comes from the line of someone called Carney from Canaccord. Your line is open.
spk06: Good afternoon. Thanks for taking my questions. The first is on the launch and the second is a clarification. First, it's good to hear that your partner's launch is tracking per your expectations. It's still early days. You have reimbursement, but if there have been any nitpicks or pushbacks against the use of Cursua IV, what have those been, if at all?
spk04: Yes, Samar, it's great to hear from you. No, we have not heard any pushback. In fact, it's a reverse. I check in with the V4 team pretty much daily. And I think the general theme is excitement. There hasn't been a lot of innovation in the CKD space and dialysis to begin with. So a lot of excitement that there's a solution now. And that's the general theme.
spk06: Understood. And then the clarification, you mentioned the inventory dynamics, the way they work in dialysis clinics. So I just wanted to clarify that on the $4.8 million of commercial supply revenue that shipment was close to actual pull-through demand?
spk04: Yeah, Tom, one, two.
spk06: I'm sorry.
spk04: The 4.8 million.
spk03: Yeah, the 4.8 million shipment. Samad, can I just repeat the question? Sorry.
spk06: Oh, the question was, with the 4.8 million, how does that shipment recognition work relative to the actual pull-through demand?
spk03: Okay, so the way that is related to shipment to our partner V4. So that's commercial supply to business and to V4. From there, the actual shipments, V4 will then ship to the wholesalers. And from there, the wholesalers ship to the dialysis organization. So the revenue that we recorded was the commercial supply to get the chain started over to V4.
spk06: Let me ask that another way then. Roughly how many months of usage would that correspond to then?
spk03: With that, we don't disclose.
spk06: Thanks.
spk11: Thank you. To ask a question, please press star 1 on your telephone keypad. Again, that is star 1 on your telephone keypad. There's no question at this time. Please continue. We have our next question. From the line of Oren Livnet from HC Wingright, your line is open.
spk05: For the last second, punch in. I think I tried a couple times. If I could just ask a little bit about, you know, I know you're limited in what you can say since V4 is launching this, but I think you can talk big picture about essentially, you know, what is the commercial model for this product in this space? We haven't talked about it in a while. You know, you mentioned the top-down model. effort from, you know, dialysis centers. So I'm trying to understand who is really the touch point that's going to drive, I guess, awareness and utilization or, you know, prescribing of this product. You know, does V4 really have to, in a typical pharma sense or launch, have to make individual nephrologists aware of and fully educated on this product before they even start thinking about prescribing it aside from patient activation and or given that these patients are actually seeing these dialysis centers every other day, are they really the driving force here such that assuming Fresenius, for example, already is intimately familiar with this product or will be very soon, are they reaching out to their affiliated physicians to sort of drive awareness of this new option that's available?
spk04: Yeah, it's a great question on the entire buying process. It's a rather unique ecosystem, and that's why I mentioned that, you know, nephrologists have to prescribe the product, so they have to be educated and made aware of the product in order to prescribe it so the patient can get it. The dialysis organizations help demand generation by talking to their clinics and training their nurses, et cetera. and making it available. So the DOs have a job to play in demand generation as well. And then the third part of that is the patients. Kind of similar to other typical prescription markets is when a patient's educated and activated and actually asked for a drug, they tend to get it. It works pretty similar here. So the buying process across all those demand levers is where V4 has allocated resources. And that's why, you know, putting my marketing ad on, that's why I'm very keen on the launch to date as well as the acceleration in the coming months.
spk05: I guess to ask it another way is without, you know, understanding the rules and the laws of the land here intimately myself, is there a possibility that a nephrologist who sends patients to Fresenius centers routinely is is going to, you know, be receiving any materials coming from the Fresenius side, not from a V4 rep directly that is, you know, raising their awareness directly about this product being available to their patients that come to Fresenius centers.
spk04: Yeah, and that's a top-down approach. The DOs can help raise awareness and educate the community as well. But, you know, V4's team has taken a bottoms-up approach as well, obviously targeting the 4,000 or so nephrologists. And as I told you, we're quite keen on execution. And as you probably know very well, launches typically fail because execution is poor. And we're seeing very strong controls on key performance indicators on the execution side by V4. And I mentioned before, they've hit pretty much all 4,000 nephrologists. in the first couple weeks of launch. It's a very strong execution number. So it's this bottoms-up, top-down approach that I think really caters to the ecosystem and ESRD dialysis.
spk05: All right. Sounds like a drinking game. Bottoms-up, top-down. The EU commercial dynamics, just also on that front, how concentrated is that market across the swath of the continent there? Is it similar? Do we have large corporate... players across, you know, a country or countries, or are these government-provided dialysis facilities, or is it just totally fragmented, and should we not think about it being similar to the U.S. market?
spk04: Yeah, I would say, you know, every country is a little different, but I would tell you it's a fairly concentrated market as well, maybe different players in the U.S. in individual countries, but concentrated as well. All right, thanks. I appreciate that. You got it. Thanks a lot.
spk11: To ask a question, please press star 1 on your telephone keypad. Again, that is star 1 on your telephone keypad. There's no question at this time. Please continue.
spk04: Okay. With that, I'd like to wish everybody a great afternoon, and thank you so much for joining the call.
spk11: This concludes today's conference call. Thank you for participating. You may now disconnect.
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