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spk09: Good afternoon and welcome to Kara therapeutics fourth quarter and full year 2020 financial results conference call all participants are now in listen only mode. There will be a question and answer session at the end, please be advised that this call is being recorded at Kara's request. I would now like to turn the call over to charity, please proceed.
spk08: Good afternoon. This is Jack Hildik-Smith with Stern Investor Relations and welcome to CARA Therapeutics' fourth quarter and full year 2020 financial results and update conference call. The news release became available just after 4 p.m. today and can be found on our website at www.caratherapeutics.com. You may also listen to a live webcast and replay of today's call on the investor section of the website. 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 Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the expected timing of the data readouts from the company's ongoing clinical trials, the potential results of ongoing clinical trials, timing of future regulatory and development milestones for the company's product candidates, including the company's projected timeline for FDA review and potential approval and commercial launch of Corsupa IV, the potential for the company's product candidates to be alternatives in the therapeutic areas investigated, and the company's expected cash reach. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in care therapeutics filings with the Securities and Exchange Commission, including the risk factors section of the company's most recently filed quarterly report on Form 10Q and its other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements made in today's call speak only as of the day 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 day on which they were made. Participating in today's call are Dr. Derek Chalmers, CARE President and CEO, and CARE Chief Financial Officer Thomas Riley. I'll now turn the call over to Dr. Chalmers.
spk04: Thank you, Jack. Good afternoon, everybody. and thanks for joining us on the call this afternoon. So despite the circumstances that we're all painfully aware of, 2020 was certainly a significant and very productive year for CARA. As we advanced the late stage clinical development of our lead product candidate, Kursuva, for the treatment of the virus across a range of patient populations. Culminating, as we announced today, in the recent acceptance and filing of our NDA for Cursiva injection for the treatment of pruritus in hemodialysis patients. This NDA filing marks a truly significant milestone for our company, and most importantly, for the large proportion of hemodialysis patients who suffer from this intractable, untreatable pruritus that is so detrimental to their quality of life. And I'd like to thank the entire CARA team who've worked tirelessly to bring this first-in-class therapeutic from in-house discovery through development to the completion of FDA filing. And we look forward to working with the FDA throughout the review process and if granted priority review, potential approval, and commercial launch in the second half of this year. Now, with respect to Cursiva injection commercial launch, we were also very pleased to execute a strategic license agreement with V4 Pharma in Q4 of last year for the commercialization of Cursiva injection in U.S. dialysis clinics. We believe that V4's established U.S. nephrology sales force and productive relationships with U.S. dialysis organizations will provide a basis for increased launch momentum and adoption of Drosuva injection in the U.S. market. And I'll cover the details for that arrangement in a little bit. Lastly, we also expanded our oral Drosuva clinical development program with the initiation of a fourth phase two trial in patients suffering from neuropathic-related pruritus. specifically Natalja Parasetica patients. Evaluating the ability to treat pruritus of a neuropathic origin, in addition to our ongoing clinical development programs in systemic and dermatological chronic pruritus, will further support the use of oral Cruciva as a future broad anti-pruritic agent. Building on this momentum from 2020, In addition to protected approval and launch of prosuva injection in the second half of 21, we expect major clinical data readouts and advancements throughout the upcoming year. And on the call today, I'll provide a brief update on each of our programs and what to expect throughout 2021. Before I get to that, let me remind you that due to the ongoing COVID-19 pandemic and in accordance with the FDA's updated guidance for conducting clinical trials, we have implemented numerous clinical and operational measures to prioritize the health and safety of patients, our employees, and study investigators, and to minimize potential disruptions to our ongoing clinical studies. And I'm pleased to say that due to the entire CARA team's continuous dedication and hard work, we remain on track today to meet our main clinical and regulatory goals for the year and continue to enroll patients across ongoing oral Cursiva trials. So getting to the program, starting with our lead program for Cursiva injection in hemodialysis patients with CKD-associated pruritus. As a reminder, this is a patient population where there is significant unmet need with approximately 40 to 50 percent of patients suffering from moderate to severe pruritus with no therapies currently approved in the U.S. or in Europe. So we believe prosuva injection has potential to fundamentally change the treatment paradigm for these patients. With the NDA for prosuva injection now filed, we remain focused, along with our U.S. licensing partner, V4 Pharma, on preparation for an anticipated U.S. commercial launch as early as the second half of this year. Now, as a reminder, under the terms of the V4 license agreement, Carrier received an upfront payment of $150 million, composed of $100 million in cash and $50 million in equity purchase. Upon U.S. approval, CARA is eligible to receive a further $50 million equity purchase, and there is potential U.S. commercial sales milestones of up to $240 million. VIFAR will have the exclusive rights to commercialize Cursiva injection in non-frazenious medical care North America dialysis clinics in the U.S. under a CARA 60% v for 40% profit-sharing arrangement. and that's based on profit from net non-Fresenius medical care clinic sales. Recall from our original CARA V4 Fresenius license agreement that we executed in 2018, we have an established 50-50 profit split arrangement in Fresenius clinics already in place for the US. So overall, we see this as an ideal agreement which allows us to both leverage V4 has established commercial infrastructure and capabilities and retained commercial upside from our profit sharing arrangement. Transition of both medical affairs and commercial launch activities to the V4 teams have progressed well since we executed that agreement over the last two quarters and we're well prepared for a potential Cursiva injection US launch as early as the second half of this year. Moving on to our pipeline programs focused on oral Kursuva. And let's start with our program in predialysis CKD patients with moderate to severe pruritus. We have previously reported positive top line results from our 12-week phase 2 trial, evaluating the safety and efficacy of three tablet strands of oral Kursuva, 0.25, 0.5, and 1 milligram once daily. Based on that data, we identified the one milligram tablet strength of oral Krasuva as the dose level to take forward into phase three. To that end, we will be conducting an end of phase two meeting with the FDA in Q2 of this year, which will enable a projected pivotal phase three trial initiation in the second half of 2021. Moving on to atopic dermatitis and their ongoing care, Phase II dose-ranging trial. In Q2 of 2020, we completed a planned interim unblinded conditional power assessment conducted after approximately 50% of the originally targeted patient number completed the designated 12-week treatment period. Based on the Independent Data Monitoring Committee's recommendation and to maintain a conservative statistical power on our main endpoints, we increased the target trial size by approximately 28%. In Q4 of last year, we announced the trial was fully enrolled at approximately 400 patients, and we currently expect to read our top line data in the first half of this year. Finally, with the goal of further establishing the broad antichorotic applicability of PROSUVA across patient populations, We recently announced the initiation of a phase two proof of concept trial for the treatment of moderate to severe pruritus in patients suffering from Natalgia Parasitica, or NP, as a nerve disorder characterized by chronic pruritus of the upper to middle back. It's estimated that chronic pruritus affects up to 13% of the United States population, and about 8% of these patients suffer from some form of neuropathic itch, including NP. There is currently no well-defined treatment for NP, and conventional treatments such as antihistamines and topical steroids are largely ineffective. So there remains a significant opportunity for oral Cursiva as a novel therapeutic approach for these patients. So overall, our progress in 2020 has laid the foundation for a transformative year ahead at CARA. We very much look forward to the projected approval and commercial launch of Cursiva injection in the second half of 2021. Top line data readout from our CARE phase two trial of oral Cursiva in atopic dermatitis in the first half of 21. Initiation of our phase three registration trials for oral Cursiva in stage three to five predialysis CKD patients in the second half of this year, as well as continued progress on ongoing phase two trials in liver disease patients and NP patients. And we'll be bringing updates on the progress across all of these programs in the coming quarters. So with that, I'll now turn over to Tom to detail the financial results for the quarter and for the full year. Tom.
spk01: Thank you, Derek. As a reminder, the full financial results for the fourth quarter and full year 2020 can be found in our press release issued today after the market closed. For the fourth quarter of 2020, we reported a net income of $78.9 million or $1.60 per basic share and $1.59 per diluted share compared to a net loss of $28.6 million or 61 cents per basic and diluted share for the same quarter of 2019. In the fourth quarter of 2020, we recognized revenue of $112.1 million, of which $111.6 million related to the 2020 license agreement with v4 and $0.5 million related to the license agreement with v4 Fresenius. This compares to $4.5 million of license and milestone revenue during the fourth quarter of 2019, which related to the license agreement with V4 Fresenius. Research and development expenses were $27.1 million in the fourth quarter of 2020, compared to $29.9 million in the same period of 2019. The lower R&D expenses in 2020 were principally due to a net decrease in costs associated with clinical trials and travel costs, partially offset by a $2.5 million milestone payment made in connection with a license agreement within tariffs, increase in payroll and related costs, and increases in stock compensation expense. General and administrative expenses were 6.7 in the fourth quarter of 2020, compared to 4.6 million in the same period of 2019. The higher G&A expenses in 2020 were principally due to increases in payroll and related costs, commercial costs, and insurance costs. Other income was 0.4 million in the fourth quarter of 2020, compared to $1.2 million in the same period of 2019. The decrease in other income was primarily due to a decrease in interest income resulting from a lower yield on our portfolio of investments in the 2020 period. Now turning to the full year 2020 financial results. For the full year ended December 31st, 2020, we reported a net income of $8.4 million or $0.18 per basic and diluted share, compared to a net loss of $106.4 million, or $2.49 per basic and diluted share for 2019. Revenues for the year ended December 31, 2020, were $135.1 million, as compared to $19.9 million in 2019. We recognized $134.4 million of license and milestone revenue for the year ended December 31st, 2020, of which $111.6 million related to the 2020 license agreement with V4, $22.3 million related to the license agreement with V4 Fresenius, and $0.6 million related to the achievement of milestone related to our license agreement with CKD Pharmaceutical. We recognized $19.7 million of license and milestone revenue for the year ended December 31, 2019, which related to the license agreement with V4 Fresenius. Research and development expenses were $107.9 million for the full year ended 2020, compared to $113.8 million for the full year ended in 2019. The lower R&D expenses in 2020 were principally due to a net decrease in clinical trial costs, lower payments made to interest, and a decrease in travel costs, partially offset by increases in stock compensation expense, payroll and related costs, and cost of clinical compound sales. General and administrative expenses were $21.8 million for the full year ended December 31, 2020, compared to $17.7 million for the full year ended December 31, 2019. The increase in 2020 was primarily due to increase in commercial costs, insurance costs, payroll and related costs, and partially offset by a decrease in consulting costs. Other income was $2.3 million for the full year ended 2020, compared to $4.5 million for the full year ended 2019. The decrease in 2020 was primarily due to a decrease in interest income resulting from a lower yield on our lower average balance of our portfolio of investments in 2020. As of December 31st, 2020, our cash, cash equivalents, and marketable securities totaled $251.5 million compared to $218.2 million at the end of 2019. The increase in the balance resulted primarily from a $38.4 million from the sale of common stock in the license agreement with V4, partially offset by $5.5 million of cash used in operating activities, which includes the $111.6 million of cash received under the V4 agreement, which was recorded as license and milestone revenue. Turning to our financial guidance, Based on the projected costs for our clinical development plans and timing expectations, we expect that our current cash, cash equivalents, and marketable securities as of December 31, 2020, will be sufficient to fund our operations into 2023, not accounting for any potential milestones or potential product revenue under existing collaborations. I will now turn the call back over to the operator for Q&A.
spk09: At this time, I would like to remind everyone in order to ask your questions, you may press star then the number one on your telephone keypad. Again, that's star one on your telephone keypad. We'll pause for just a moment to compile the Q&A roster. Your first question comes from the line of David Amsalem from Piper Sandler. Your line is open. Mr. David Amsalem, your line is open.
spk04: You know, we can move on. It's obvious David has a problem there. Maybe he solves that and we go back to him.
spk09: Your next question comes from the line of Annabelle Samimi from Spiegel. Your line is open.
spk07: Hey, everyone. This is Avatar on for Annabelle today. A couple questions from us. Firstly, with the NDA filing for IV Coursiva accepted in February, When do you expect to know whether the drug is granted priority review? And secondly, are you able to provide an update on progress made by V4 on SEDAPA reimbursement discussions? And does the fact that there are numerous renal drugs seeking SEDAPA inclusion make these discussions any more difficult?
spk04: OK. Hi, Avatar. Thanks for that. Yes. So on the first question on the NDA, so We had confirmation from the FDA this week electronically that the NDA was accepted and filed. But within that confirmation for filing, the FDA also indicated that the official filing letter was still in process. So that was in process. We have not yet received that letter. And therefore, we don't yet have information on priority review or indeed the PDIFA date. We expect that letter to arrive soon, but the FDA being the FDA, there's no prediction on timing yet, unfortunately. On the reimbursement question, of course you're aware that TdapA reimbursement is not discretionary. We qualify for TdapA reimbursement by meeting the criteria that are legislatively defined and the ESRD legislation. So we're a Class 1 NDA. We're approved after January 2020, and we're going to be using the dialysis setting. So that we're very confident upon, and we have a good team at CARA who continues to lead our interactions with CMS in discussions not only related to Tdapa, but reimbursement beyond Tdapa. Now, we started to include our partner there, in those discussions and they will have useful input as we progress those discussions. But Tdapa is something we qualify for and we'll be applying for that after we get approval of Cursiva injection.
spk07: And does the sort of desire for many companies to be included in Tdapa sort of complicate those discussions or timelines?
spk04: Well, I don't think so. That's, you know, the way the legislation was defined was to encourage innovation for hemodialysis patients. And if those companies' compounds meet those criteria for an innovative compound for the treatment of hemodialysis patients, then they would qualify for Tadato. Got it. Okay, Avatar.
spk07: Thank you, Derek.
spk04: Thanks for your call.
spk09: Your next question comes from the line of Christopher Howerton from Jefferies. Your line is open.
spk02: Hi, everyone. This is Brian for Chris here. So I have two questions. The first one is if you could speak a little bit about the dosing decisions in the CKD, AD, and neuropathic pain studies, and whether this corresponds to any differences in disease severity. So specifically, We were interested in what led to your decision to choose two milligrams versus one milligrams twice daily in the neuropathic pain study. The second question would be around if there's any relevant differences in the characteristics or underlying biology resulting in colitis in the CKD and AD populations and what the key supportive evidence is that gives you confidence for success in ADs. Thanks so much.
spk04: Yeah, thanks, Brian. You know, the dosing question is actually really related to PK. and availability of the drug. So for the CKD studies, oral studies, as you know, cruciva is eliminated almost entirely via the kidney. And so we looked at the PK exposures in specifically stage 3 to 5 CKD patients to define what tablet strength and frequency of dosing would match the AUCs we know were you know, highly efficacious from our IV studies. And that's why we come up with a dose of one milligram QD for the CKD patients. When we moved to atopic derm there, those patients, of course, have normal kidney function. And so to meet, and again, we looked at the PK and normal individuals and to match that, you know, desired AUC there, we needed to get twice a day dosing. at the one milligram level. So that was the rationale really on those two studies. On the Natalgia Parasitica, we really view this as a proof of concept trial. And we know, particularly in preclinical models, looking at neuropathic pain, you know, different modality, but actually same system in terms of peripheral nerve transmission via the DRG. that we require slightly higher drug dosaging in those neuropathic type models. And so that was partially the rationale behind pushing up the dose there when we look at neuropathic related pruritus. And also, you know, as a proof of concept trial, we'd rather use a higher dose and see what level of efficacy we can achieve there, a single dose. And as you know, we've dosed this drug up to 10 milligrams a day orally with no safety concerns, so it's well within the range we've used before. And then your second 30,000 foot question on mechanism, you know, we've indicated this a few times. I think when we look at the mechanism for Cursiva actually related to activation of Kappa receptors directly on the C fibers and the epidermis and dermis that relay the pruritus, you know, that mechanism is really agnostic to the initiating pathology. So whether that's a CKD and organ disease, and we know the cytokine profile there, and it's certainly different in the dermatological inflammatory state, that really shouldn't make a difference based on our mechanism of action to efficacy. And that's certainly something we've seen in preclinical models of various, you know, pathologies. And we've took this drug all the way to to transgenic models associated with, for example, atopic dermatitis and showing good efficacy in those, you know, validated predictive models. So we have high confidence in the mechanism there, which should really be agnostic to the initiating pathophysiology. But we don't, the good news, Brian, is we don't have too long to wait to actually get the answer on that empirically. So that's upcoming. And we're looking forward to that. Great. Thank you. Thanks, Brian.
spk09: Your next question comes from the line of Jason Gerberry from Bank of America. Your line is open.
spk06: Hey, guys. Thanks for taking my questions. Yeah, I guess, Derek, just kind of curious to get your thoughts. You know, Amgen's update on parsifibs kind of coming out of the Tdapa phase guiding to, I think, a 40% or 50% year-over-year decline in revenue. Is this how investors should be thinking about sort of drugs coming out of this Tdapa phase where there's maybe a better price point? Just kind of trying to reconcile that versus the CARA consensus where there's growth in year three in year four of the launch, but just wondering how to think about that price reset dynamic that we've talked about in the past. And then second question is just curious about, you know, thinking about the parts of the launch a little bit more closely, wondering if you have any perspective on why the uptake was low with large dialysis organizations versus small dialysis organizations. You know, is there a concern amongst the LBOs that once you start using these medications, it's difficult to kind of pull back? And the copake, you know, component of this could be something that the LBOs typically absorb. So I'm wondering if you can comment on those two dynamics as we start to think about commercial here. Thanks.
spk04: Yeah, thanks. Thanks, Jason. I mean, I think the first thing to see right up front that you're well aware of, Jason, that Parziviv is an entirely different class here. and directed at an entirely different issue associated with dialysis patients for which there are existing alternatives already out there, including Anges' own drug, Sensipar. So I think that has a lot to do with the point you're raising on revenue decline as the availability of a number of alternatives out there that are, quite frankly, much cheaper than Parsabiv was. That will not be the case with pursue, as you know, a breakthrough drug. We're really going to be the first drug approved for CKD pruritus. And there are no alternatives to revivification. Certainly nothing we've seen very effective in an RCT in that patient population. So I think it's quite a bit of apples and oranges there in terms of the parts of the change post the data. You know, your question related to the views of LDOs versus the more mid-sized and independent analysis organizations. Again, I think Persebev might have specific issues related to those. I can't really speak to the smaller organizations. We don't really have their view, but as you know, we've worked with Fresenius now for a couple of years, and we know the enthusiasm that they've relayed. and the need for this therapeutic for the patients. And as you know, they're all striving as part of their assessment on reimbursement to improve patient standard of care. And they see this as a huge unmet need, and they're very keen to get involved and move in this drug along. So, you know, that doesn't answer the question to the independence and the differentiation there with parts of it, but we know from our experience with the large analysis organizations, they're very keen to get in with Cresuva and use the drug. And of course, they have their own internal databases related to, you know, prevalence of pruritus within their patients.
spk06: Okay. Well, great. Thanks so much for the useful insights.
spk04: Great. Thanks, Jason. Thanks for the questions.
spk09: Again, I would like to remind everyone, in order to ask your questions, press star, then the number one on your telephone keypad. Again, that's star one on your telephone keypad. Your next question comes from the line of Joseph Stringer from Needham & Company. Your line is open.
spk06: Hi, everyone. Thanks for taking our questions. I was wondering if you could detail where oral cursive or atopic dermatitis, where you see that fitting into the current treatment paradigm. And then as a follow-up for the upcoming Phase II readout, is it fair to think about comparisons to some of the Phase II data from the oral JAK in terms of itch NRS reduction and also four-point improvement in itch NRS response rates? Thank you.
spk04: Great. Thanks, Joe, and congrats on the new position at Needham. Yeah, so when we think about atopic dermatitis, of course, pruritus is the defining symptom for that disorder. And that level of pruritus, high level of pruritus, occurs really regardless of the degree of pathophysiology there. we can recruit and have done in our clinical trials patients with very high levels of paritis, certainly qualifying as moderate to severe, whether they have mild to moderate pathology associated with the atopic dermatitis or indeed moderate to severe pathology. So this is a primary symptom across the whole spectrum of atopic dermatitis. Today's therapeutics for the mild to moderate are really confined to topical, medications. And the medications being developed in the atopic that are beyond topicals, of course, we have Depixen approved as a IL-4, IL-13 biologic, and we have the JAK inhibitors, as you indicate coming through, are really targeting the moderate to severe pathology. That's their niche. That's where they're going to be reimbursed. And that's where dermatologists are most likely be willing to use those and accommodate the associated, you know, safety risks that are going to ensue from both biologics and particularly JAKs. So those molecules coming through are really focused on about 20% roughly of the US atopic dermatitis population. Cursiva, on the other hand, we see positioned as being broadly applicable from mild to severe pathology. So it's a much broader applicability. And frankly, we see it, particularly in the mild to moderate population, as being a candidate for first-line therapy there, maybe after some topical usage or in combination with the topical. In the moderate to severe range, again, I think it could be monotherapy for those patients, and also theoretically combined with any other modalities, biologics, or JAKs for the more severe patients. And as you know, and we've talked about a number of times, there's There's no active metabolites for this drug. It's excreted whole via the kidney. There's no potential for drug-drug interaction. We can see that's used in combinations with any other classes of medication. So that's how we see it being positioned as a much broader applicability potential first-line therapy for the whole of the AD populations. And then getting to the AD reader, I guess we'll be You know, I think we've discussed this before that, you know, in the dermatological situation, it's certainly dogma at the derm division that a four-point responder analysis would be the appropriate registration endpoint. We're certainly looking at that as one of our major endpoints in the atopic derm trial. And as you know, we designed our interim analysis focused on that four-point as well as our mean NRS change from baseline. So we are looking at that, Rita. In terms of level of response, you know, I think the peg cent is in the 40% responder rate. Some of the JAKs are a little higher, but really only at the very highest of dosages for those compounds. They may creep into the 50%. So, you know, a win for us is separation from placebo. That's our primary aim here. And again, this is going to have an entirely different profile. So we'd like to see a nice, appropriate biological window here. But again, we're looking for orally available, well-tolerated, safe medication, which is really something that, as you well know, dermatologists are looking towards as the desired profile for that patient population. So efficacy, but with improved safety, is going to be the profile that's going to win against particularly genetics that are coming through for the moderate to severe population. Does that help position where we see this, Joe?
spk06: Yes, that's great.
spk00: Thanks for the detail.
spk04: Thanks for the question.
spk09: Your next question comes from the line of David Amsalem from Piper Sandler. Your line is open.
spk03: Thanks, and sorry for my audio issues earlier. Thanks for fitting me in. So I wanted to dig more deeply into the atopic derm study, and the first question is just remind us about the extent to which patients are or are not allowed to be on any background medications, whether they're topicals or systemics, and just talk about that as part of the the inclusion-exclusion criteria. And then secondly, to the extent that you have favorable data and that you do move into Phase 3, just talk through that same topic, whether you expect you're going to have to include patients with some form of background medication as a form of sort of a real-world design, if you will. And then secondly, just more broadly on a Phase 3 program in atopic derm, Is it safe to assume that's going to be sort of two identically designed phase three trials? Are you going to have to do more long-term safety work? And just help us understand just sort of the rough contours of what you think you're going to need to do there. Thanks.
spk04: Yeah, thanks, David. I'm glad you're back on the line. So in terms of the phase three design, you know, I'm hesitant to go too far into that. As you know, we haven't yet had an end of phase two, and we're awaiting our readout from our dose-ranging trial. We have started to think about that and prepare for that, and we do see that as a normal phase three program for a chronic use drug, and we are planning two simultaneous U.S. trials. I can't tell you the ultimate size of those because I need my phase two data to look at effect size there, but that's That's our thoughts and exposures that would be in line with ICH guidelines for chronic use medication. At this point, we're not, you know, again, I don't want to get into promising not to do something with the FDA, but at this point, we're not planning on extensive trials, including, you know, co-administration of other medications. And that might be something that comes up, particularly with topicals, but at this point, we're not particularly planning on that. Um, and then I guess the easier, uh, question for, for, for your first, uh, answer for your first question on, on the phase two design yet we wash and have washed, um, these patients out of all medications, uh, as an entry criteria and to the phase two trial. So that's really as a pure, um, you know, monotherapy trial, with no influence of background medications there. And if anyone did take systemic rescue there, they would be dropped from the efficacy calculation for that trial. So that is going to be a pure trial with no co-medications there for the patient. Okay, great. Thank you. Thanks, David.
spk09: Your next question comes from the line of Ben Shim from Canaccord. Your line is open.
spk05: Hi. Thanks for taking my questions and for all the details on the clinical development. I just have a quick question. Maybe you may not be able to answer this, but what is your sense of vaccine uptake amongst, you know, trial center employees, personnel, and maybe prospective oral course super trial patients or even currently enrolled ones. I'm just wondering if the increased supply that's expected to come on board over the next few weeks could be a tailwind for your expectations on enrollments.
spk04: Thanks, Ben. You know, I think you're right on your assumption there. I'm not sure I can answer that question for you. I'm not even sure we've looked at that particular metric in our clinical trial size, so I really don't know what the vaccine uptake is at this point in our trials. It may be something we learn at the end of the day for our ongoing trials, but I really don't have any data on that metric right now.
spk05: Okay. Maybe a question for Tom. Looking forward to commercialization, what level of visibility will we have on the underlying IV course of the sales both U.S. and ex-U.S.? I understand we're going to be seeing profit share revenue reported in the top line. I'm just wondering if there's going to be other confirmatory data available.
spk01: Sure. Thanks, Ben. So VIFOR will be recognizing the top line revenue on their side. So net sales will be recorded on their books. So there'll be visibility on that end. And correspondingly, based off the profits share that we receive back, that will be recognized as revenue on our end. So there'll be visibility into the revenues based off of that mechanism.
spk05: Okay, great. Thank you very much.
spk01: You're welcome.
spk09: Again, for anyone who wants to ask questions, you may press star then the number one on your telephone keypad. There are no more questions at this time. Turning the call back over to Dr. Derek Chalmers.
spk04: Okay, thank you. Thank you everybody for participating in the call today. I'd also again like to thank the CARA team, our study investigators, and all the patients who continue to participate in our ongoing clinical trials. And we look forward to updating you again very soon. Thank you very much and have a good night.
spk09: Ladies and gentlemen, this concludes today's call. Thank you again for your participation. You may now disconnect. Have a great day.
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