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spk08: Good afternoon. My name is Andrew, and I will be your conference facilitator. I would like to welcome everyone to the CARA Therapeutics fourth quarter 2021 financial results and update conference call. All lines have been placed on 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 key. Please be advised that this call is being recorded. I would now like to introduce Iris Francesconi, Interim Head of Investor Relations from Care Therapeutics. Ms. Francesconi, you may begin your call.
spk01: Thank you, Andrew, and good afternoon. Just after market closed today, we issued a press release detailing our corporate progress and financial results for the fourth quarter and full year 2021. Press release 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. Participating in today's call are Chris Posner, CARA's President and Chief Executive Officer, Tom Riley, CARA's Chief Financial Officer, and Joanna Goncalves, CARA's 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 Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the company's ability to successfully commercialize Cursiva injection, including the timing of the product launch, planned future regulatory submissions, and potential future regulatory approvals. the company's ability to obtain and maintain coverage and adequate reimbursement for Koshu injection, the performance of our commercial partners, including B4 Pharma, expected timing of the initiation, 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 company's expected cash reach, and the potential impact of COVID-19 on the company's commercial launch, 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 by such forward-looking statements. Risks are described more fully in carotherapeutics filings with the Securities Exchange Commission, including the risk factor section of the company's most recent annual report, on Form 10-K 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. Kara Therapeutics undertakes no obligation to update such statements to recent events that occur or circumstances that exist after the date on which they were made. With this, I will turn the call over to Chris.
spk07: Thanks, Iris, and good afternoon, everyone. With me today are Tom Riley, our Chief Financial Officer, and Dr. Joe Consalves, our Chief Medical Officer. Today I will give you a quick review of our tremendous progress delivering against our milestones, commitments, and plan. Then I will provide some updates on our preparations for the launch of our first product, Corsuv Injection. Tom will follow with a financial update, and then after that we will be available to take your questions. I am very excited to join you today to lead my first quarterly earnings conference call as CEO of Kara Therapeutics. In my first 120 days in this role, I have listened and learned to make sure we are doing the necessary things to build trust in our ability to deliver on our goals and continue growing. I am confident that we have the ingredients to build a long-term growth platform here at Kara, and it starts now. We have the right strategy in place, and our work ahead is very focused on executing against our strategy. We are building the category-defining leader in paritis. This guiding mission drives our strategy and our actions. Chronic paritis is often a severe, intractable problem for patients in a wide range of diseases, and it is underserved by currently used treatments. In light of this lack of treatment options, chronic pruritus remains underreported, even though it can have a significant negative impact on the quality of life of millions of patients. We are committed to enhancing the awareness of this disease and improving the treatment protocols for patient care so that our novel science benefits the most patients possible. Over the past year, we made excellent progress executing on three strategic priorities. Our first priority is to optimize the commercial potential of Corsuv injection. In 2021, we had a defining moment at CARA. In August, Corsuv injection became the first and only FDA-approved treatment for moderate to severe pruritus in adult chronic kidney disease patients undergoing hemodialysis. With pivotal data in more than 1,300 patients, our team swiftly submitted the NDA to the FDA for priority review. Now, as you will recall, we granted V4 Pharma an exclusive license to commercialize Corsuva injection in the U.S. V4 Pharma has been working diligently to prepare the market for this important new product. This is a readily addressable market of $200,000 U.S. hemodialysis patients with moderate to severe pruritus associated with chronic kidney disease. In addition, CMS granted Korsuv injection to DAPA reimbursement status in December. Now, I will provide more detail on the current launch preparations in a moment. Outside the U.S., we also see significant opportunities for Korsuv injection. We expect the European Medicines Agency to make a decision on our MAA in the second quarter of this year based on the CHMP positive opinion last week. As a reminder, an EMA approval entitles us to a $15 million cash milestone payment from our ex-U.S. partner, V4 Forcentius Medical Care Renal Pharma. In Japan, our partner, Mariushi Pharmaceuticals, recently announced positive Phase III study results. Our second strategic priority is to advance our oral Corsuva platform into Phase III pruritus programs for advanced chronic kidney disease not requiring dialysis and in atopic dermatitis. Following end-of-Phase II meetings with the FDA, we have a clear path forward with these two pivotal programs. We expect to initiate phase three trials in both indications this month. There will be more details on these trials at our upcoming virtual R&D day on March 11th, which I hope you all can join. Our third strategic priority is to expand the clinical utility of oral Corsuva in other therapeutic areas, including Notalgia Parasitica and chronic liver disease. Because of its novel mechanism of action, we see oral Corsuva with the potential to be a pipeline and a product, treating chronic pruritus across a broad spectrum of diseases. In 2022, we expect data readouts from Phase II proof-of-concept studies in notalgia parasitica and in primary biliary cholangitis. In both trials, we expect to see separation from placebo at the respective endpoints. These trials will provide us with critically important information to inform our path forward in these indications. Now, I'd like to provide more insight into the preparation and execution of the impending launch of course of injection, and we are excited and we are prepared for the upcoming early April launch. First and foremost, we have the right partner in V4 Pharma who will be leading commercialization efforts. Together, we have a terrific partnership. We have a joint steering committee that makes all key decisions concerning the launch and commercialization efforts. Our commercial partnership with V4 gives us a reach and frequency as well as efficiency and speed. V4 is a leading nephrology company with a large sales force and long-standing relationships with key prescribers and dialysis organizations. particularly one of the top two, Fresenius, with whom they have a joint venture. The focus has been on a fast start to the launch of course of injection. To achieve that, the cross-functional commercialization team has completed an array of pre-launch activities. These activities will allow us to hit the ground running from the first day and hopefully steepen the launch trajectory. Three pillars support our pre-launch work. First, The V4 sales force is trained and engaged to prepare the market for launch. V4 is deploying a sales force of approximately 100 representatives. This field force has been conducting disease state education since the fourth quarter of last year for pruritus patients on hemodialysis. Throughout the first quarter of this year, the sales team has been engaging with the entire range of healthcare professionals, including physicians, advanced practice providers, and nurses. in an effort to identify prospective patients who could begin therapy quickly once Corsuva injection is available. In addition, sales representatives have been trained on the package insert, and they are currently using the PI in their ongoing discussions with healthcare providers. All promotional campaign materials are also completed and ready to go. Representatives will be trained on these materials at live meetings in March. the commercial team has made significant progress on pricing, reimbursement, and access. On pricing, we have set a list price, or WAC, for Korsuv injection of $150 per vial, or roughly $21,000 per patient per year. On reimbursement, Tdapa and the J code for Korsuv injection are effective April 1. On access, V4's account team is actively engaged in formulary discussions with dialysis centers, and we're really confident that course of injection will be on all formularies. The consolidated nature of this market helps with this important process and the launch overall. Recall, the top six large dialysis organizations represent about 90% of the total market. We fully expect the product to be available at the dialysis centers. The third pillar is preparing the supplier product to drive a robust launch. We have manufactured sufficient launch quantities of course of injection, and the product is already at the distribution center awaiting shipment to wholesalers and dialysis centers. One final note on the launch. As an anchor product, we see course of injection and its launch as a solid step in the validation of our mission and our strategy. Paritis is a significantly underserved symptom across many diseases, and patients want and need new treatment options. Positive anecdotal feedback from healthcare providers in recent months is an early but important indicator that we are on the right track. In conclusion, we are on the road to creating significant value. In 2021, we did what many companies have not managed to do, identify and bring a novel drug through clinical development to approval as a first-in-class therapy. We have also made significant progress in building our oral Coursiva platform. Looking ahead, we see 2022 as a transformational year for CARA. Our focus on execution gives us confidence that we will deliver on our strategic priorities and our objectives. The first priority is to optimize the commercial potential of course of injection. Through our partner, V4, we plan to launch the first and only approved product for pruritus patients on hemodialysis. We are ready to roll for the launch with the field force, pricing and reimbursement, and product availability all in place. Second, we are advancing our world course of a platform with two pivotal phase three programs for pruritus and in advanced kidney disease and in atopic dermatitis. We are in the process of initiating both programs this month, and we are excited to detail these programs in more depth at our upcoming R&D day. Third, we are expanding the clinical utility of oral Corsuva in other therapeutic areas, including notalgia parasitica and chronic liver disease. with Phase II readouts to further characterize the potential of our product pipeline. I look forward to interacting with all of you over the coming months as we build CARA into the leader in chronic pruritus. Now, I'd like to hand it over to Tom, our CFO, who will go over our fourth quarter and end of year results in detail. Over to you, Tom.
spk05: Thank you, Chris. As a reminder, the full financial results for the fourth quarter and full year 2021 can be found in our press release issued today after the market closed. For the fourth quarter of 2021, net loss was 33.4 million or 6.3 cents per basic and diluted share compared to a net income of 78.9 million or $1.60 cents per basic and $1.59 cents per diluted share for the same period in 2020. In the fourth quarter of 2021, we reported $0.8 million of revenue compared to $112.1 million during the same period of 2020. In Q4 2021, we recognized $0.7 million of commercial supply revenue related to our sales or cursive injection to V4. Q4 2020, we recognized $111.6 million related to the license agreement with V4 and $0.5 million related to the license agreement with VFM CRP. Research and development expenses were $22.8 million in the fourth quarter of 2021, compared to $27.1 million in the same period of 2020. The lower R&D expenses in 2021 were principally due to a decrease in costs associated with clinical trials and decreases in payroll costs, partially offset by $5 million in milestones earned by NTERRS during the three months ended December 31st, 2021, compared to $2.5 million during the same period of 2020. General and administrative expenses were $11.5 million in the fourth quarter of 2021, compared to $6.7 million in the same period of 2020. The higher G&A expenses in 2021 were principally due to increases in stock-based compensation expense, which includes $5.1 million of incremental expense related to the modification of our former CEO Equity Awards in November of 2021. In addition, an increase in payroll costs, legal fees, and insurance costs, partially offset by decrease in consulting costs and commercial expenses. Other income was 0.1 in the fourth quarter of 2021 compared to 0.4 million in the same period of 2020. 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 2021 period. Now turning to the full year 2021 financial results. Full year ended December 31st, 2021 We reported a net loss of $88.4 million or $1.74 per basic and diluted share compared to net income of $8.4 million or $0.18 per basic and diluted share for 2020. Revenue for the year ended December 31st, 2021 was $23 million as compared to $135.1 million in 2020. In 2021, we recognized $15 million related to license agreement with VFM CRP, $5 million from V4 Pharma related to the premium paid by V4 Pharma for the $50 million equity purchase. We earned $1.9 million in January 2021 from Mariushi related to the indication, the initiation of the first phase three trial for uremic pruritus. and $0.7 million of commercial supply revenue related to our sales of Kursuva injection to V4. For the year ended 2020, we recognized $111.6 million related to license agreement with V4 and $22.3 million related to license agreement with VF MCRP. Research and development expenses were $82.7 million for the full year ended December 31st, 2021, compared to $107.9 million for the full year ended December 31, 2020. The lower R&D expenses in 2021 were principally due to a decrease in clinical trial costs, partially offset by $15 million in milestones earned by Interis during the year ended December 31, 2021, as compared to $5 million during the same period in 2020. An increase in stock-based compensation expense and payroll costs. General and administrative expenses were $29.4 million for the full year ended December 31 compared to $21.8 million for the full year ended December 31, 2020. The increase in 2021 was primarily due to an increase in stock-based compensation expense, which includes $5.1 million of incremental stock-based compensation related to the modification of her former CEO's Equity Awards in November 2021. In addition, increase in payroll costs, legal fees, and insurance costs, partially offset by decreases in consulting costs and commercial costs. Other income was $0.6 million for the full year ended December 31, 2021, compared to $2.3 million for the full year ended December 31, 2020, The decrease in 2021 was primarily due to a decrease in interest income resulting from a lower yield on the lower average balance of our portfolio of investments in the 2021 period. As of December 31st, 2021, our cash, cash equivalents and marketable securities totaled $236.8 million compared to $251.5 million on December 31st, 2020. The decrease in the balance resulted from $60.1 million of cash used in operating activities, which is partially offset by $65 million of milestone payments received from V4 and VF MCRP upon the FDA approval of course of injection, of which $20 million was recognized as revenue in Q3. Now turning to our financial guidance, based on the projected cost for our clinical development plans and timing expectations, We expect that our current cash, cash equivalents, and marketable securities as of December 31st, 2021, will be sufficient to fund our operations through 2023, not accounting for any potential product revenue or receipts of milestone payments under existing collaborations. With that, I will now turn the call back over to Chris.
spk07: Thanks, Tom. In summary, we believe we are executing preparations that will drive significant immediate growth and help drive growth in the years to come. We have three core elements fueling our growth engine. Corsuv injection. We are focused on executing the U.S. launch of our first product in April. We and our partner, V4, are prepared. Corsuv injection is a first-of-its-kind product for the treatment of pruritus in chronic kidney disease patients on hemodialysis. and we are ready to maximize its potential in the U.S. and eventually in the EU and other countries. Second, our R&D pipeline. We continue to take disciplined steps to advance our oral Corsuba pipeline, which we think has the potential to be a pipeline and a product platform across the spectrum of pruritus. We are focused on turning this potential into reality, including two Phase III programs starting this month. and we have the strong financial foundation to drive this exciting pipeline to deliver on our growth strategy. That strategy is to be the leader in bringing new treatments to the underserved patient population with pruritus, an under-realized market opportunity of millions of patients. The launch of our anchor product, Corsuv Injection, and the profitable economics of our V4 commercial partnership will make our foundation even stronger to help us get there. Now, with that, Tom, Joe, and I will be happy to take your questions. So, Andrew, you can now open up the call for questions.
spk08: Yes, sir. As a reminder, ladies and gentlemen, if you have a question, please press star then 1 on your telephone. Our first question comes from the line of Joseph Stringer with Needham & Company.
spk03: Hi, everyone. Thanks for taking our questions. You know, Chris, I'd be curious to get your thoughts just from a higher level on launch expectations, given your experience. And, you know, what are some of, you know, some comps that we could think about? You know, one in particular that's somewhat of a comp would be, you know, Amgen's parsitive. Certainly some similarities there, but key differences. I was wondering if you could sort of compare and contrast, you know, how you think Corsuva launch could go relative to that drug or any other types of comps that come to mind. Thanks.
spk07: Yeah, thanks, Joey. Great hearing from you. So, you know, let me first talk about how I think about the upcoming launch. And I'll preface that by saying it's incredibly exciting to launch a first and only product. And I think about this launch in a couple different ways. First, it's a significant, significant condition. And as I mentioned in my prepared remarks, you know, the total addressable population is about 200,000 patients. It's very much underreported by patients and overlooked by physicians. And we see, you know, a lack of significant treatments. You know, again, the standards of care are typically, you know, the Benadryls of the world. So as I think about, you know, kind of the overall launch dynamics, it's incredibly conducive to a strong launch. You know, one could think about first the overall market dynamics of reimbursement. You know, we have reimbursement, as I mentioned, with Tdapa, and now we have a JCODE, and we'll be ready to roll in April. It's a very concentrated physician audience of about 4,000 nephrologists, It's a very concentrated audience in terms of dialysis organizations, where you have Fresenius and DaVita accounting for roughly 80% of all the dialysis patients. And lastly, and most important, it goes down to execution. And we have the right partner, V4, which is the leading nephrology company, and they have an established sales force with strong infrastructure. So if you think about those, Joey, in terms of the drivers for success, they point to a very strong adoption strategy. The second part of your question was around comps, and you mentioned the Amgen product, Parsiviv. And we look at that as probably a good analog during the Tdapa period, but probably not a great analog after the Tdapa period. So during the Tdapa period, you know, what we saw with Parsiviv is very strong uptake. You know, it had, I believe, you know, $300 million the first year in 2018, $550 million. The second year and close to that, the third year. So a cumulative total of about $1.3 billion in net sales. You know, and we feel, again, that was the only product that ever went through to DAPA will be the second one. Post to DAPA, you know, obviously there's a lot of differences. That had competition. That had a generic oral equivalent called Sensipar as well as a brand at Sensipar. We'll go into the period after to DAPA, Joey, with no competition. So, again, net-net, the fundamentals of our value proposition remains incredibly strong. So, you know, I would conclude by saying, you know, the market dynamics support a very, very strong launch and a very strong trajectory, but also sustained launch success, given the fact that the value proposition will be maintained with the lack of competition and the remaining unmet needs in the space.
spk03: Great. Thanks for the color. Very helpful, and thanks for taking our question.
spk08: Thanks, Joey. Thank you. And our next question comes from the line of Chris Howerton with Jefferies.
spk12: Hi. This is a combi zone for Chris. Thank you for taking our questions. Tim, what does the performance metrics for IV Corsuva launch look like? Are you expecting any pent-up demand for the launch, and how do you anticipate COVID-19 impacting the launch? And then maybe as a second question, a set of questions, is there any reason there was a lag between December and the decision and the DAPA implementation in April? Thank you.
spk07: Hey, Chris. Let me take the last one. So the last one first in terms of what you said, the lag. So when we received Tdap in December, it's a 90-day implementation period. So the CMS has the implementation at April 1. So that was via the CMS. That was fully expected. So that's the last part of your question. The first part around metrics for success, I believe you asked, and pent-up demand is, The great thing, getting an approval last August and what we've seen with V4 and what we agreed to them for this preparation period is around strong market shaping. So V4 has been out really for the last six, seven months doing the proper disease education awareness, talking to the 4,000 nephrologists that they target, as well as focused on the nurses and as well as dialysis organizations. So, you know, again, with the proper disease awareness, the market shaping and product shaping that's been underway really for the last eight months, we feel it's going to be, again, a very strong launch beginning in April. Thank you.
spk08: Thank you. And our next question comes from the line of Annabelle Samimi with Stiefel.
spk04: Hi, this is Nick Rubino for Annabelle. Congrats on the quarter and thanks for taking our questions. I have two commercial and then maybe just a follow-up if I could. So just to drill down on the post-Tedava period, should we expect the bundle reimbursement paradigm to cause kind of volume inflections likely with some level of lower pricing. And then shifting to the EU, congrats on the positive CHMP opinion. But what should the kind of Capruvia launch look like? Obviously, before Fresenius is still leading the charge, which is definitely a big benefit, but there's more reimbursement blocking and tackling. Kind of when should we expect contribution to come through there?
spk07: Thanks, Nick. Thanks for the question. So the first question is post-HDAPA. So, you know, this is how we think about post-HDAPA. I mean, we think, you know, it will be in the bundle, but we think very strongly that it will be properly funded post-HDAPA. Again, the value proposition of course of injection will remain very strong because if you look at the competition, there is no competition coming. So we will be the first and only, and that will really strengthen as we go through as more patients get on therapy. So, again, we think we're very optimistic that post-ADAPA funding will be secured. The second question in terms of the EU, we think there's obviously a very large opportunity in the EU. If we think about the patient size, there's roughly 300,000 patients on hemodialysis in the EU. and roughly about the same in the U.S., about 40% of patients experience moderate to severe pruritus, depending on the country. And additionally, I think it's really important, again, we talk about value proposition a lot, there are no approved products to treat CKD, pruritus, and hemodialysis patients in the EU. So there may be some pricing differences, clearly, between the EU and the U.S., but it's still a very significant opportunity.
spk04: Great. And then just switching to oral Corsuva real quick. Congrats on the stage four, five expansion. Just wondering if you can kind of give us how you're thinking about powering assumptions for the placebo arm now that it's, you know, you know that it's going to be stage four and five inclusion. Are you looking more at the IV Corsuva studies to help you think about that or more of the phase two study you did before with stages three to five.
spk07: Yeah, Nick, let me turn that over to Joe.
spk06: Thanks, Nick. As you know, we're going to be conducting our R&D day next week, and we'll be sharing a lot more about the phase three designs and can give more details at that stage.
spk04: Okay. I guess I'll be patient. Thank you.
spk08: Thanks, Nick. Thank you. Our next question comes from the line of Sumant Kulkarni with Canaccord.
spk10: Good afternoon. Thanks for taking our questions. I have a couple. On the price that you've set, can we assume very modest discounting of the 21K list, if any? And what might be a real-world addressable peak share or utilization rate in the Tdapa period? And then I have a follow-up.
spk07: Hey, Sumant. Great to hear from you. So on the price, I mean, in terms of contracting, there is some contracting in Tdapa. the buy and build space, but it's certainly not as significant as you would typically see in Part D. So there will be some contracting, but it's very early to kind of assess what that would look like. And your second question, Samant, so your second question was around peak share. Yeah, I think, again, at this point we're not guiding to sales forecasts. But what I can tell you is that we're excited about the early adoption of this product. And what we're hearing anecdotally from physicians and dialysis organizations is a real keen interest in this product. I just always reinforce the value proposition, you know, the significant burden of this disease and really the lack of treatment. There are no approved treatments for pruritus. So, you know, that's how we're kind of thinking about a very strong adoption curve for Korsuv injection. And I believe, Sumat, you had a second follow-up.
spk10: Yes, it's more a pipeline-based thing. Is it fair to assume that Natagia parasterica remains one of the more relatively challenging H-based indications to target? And given that dynamic, how should we expect or read through anything you might learn from the upcoming oral Korsuva dataset in NP to your oral Korsuva pivoted programs in pruritus and atopic dermatitis, for example?
spk07: Yeah, let me turn that to Jill.
spk06: Thank you. So, indeed, narcolepsy parastatica is quite a challenging itch, and we call it the 22 treatment options, and very difficult to manage. There are no currently approved treatments. So we are excited about our study and look forward to our data readout in the second quarter of this year. Thanks.
spk08: Thank you. And our next question comes from the line of Jason Gerberry with Bank of America.
spk07: Hey, Jason, I think you're coming in and out. I don't know if you're connection.
spk11: Hi, this is Chiang for Jason. Thanks for taking the question. Can you hear me now?
spk07: I can hear you perfectly. Yeah, go ahead.
spk11: Yeah, thank you for taking the question. So I guess the first question I have is on the upcoming Phase II data readout. Can you talk about how to avoid the expectation for the readout? I know you had said expecting, looking for separation from placebo at respective studies. So I'm curious, is it a signal-seeking exercise where you're looking for numeric separation, or are you looking for Step 6 results for the respective Phase II studies? And I guess when you look at the primary endpoint for each study, they are looking at change from baseline in each score. So I'm curious, can we expect any respondent analysis from the top line results similar to prior readouts in CKD? And I guess on that point, would you expect ultimately the registration or endpoint for these indications to be either on responder rates based on either 3-point or 4-point improvement score, similar to stuff like in the CKD and similar to the dialysis settings? And I guess ultimately, if it is changed from baseline, how should investors interpret the data as they extrapolate into what could be a potential registration or endpoint?
spk07: Sure, sure. Gia, let me turn that to Jo, and she can address those questions one by one.
spk06: Sure. So let me first address your first question regarding our expectation. Indeed, these are proof-of-concept studies, as a reminder. So we are looking for numerical separation from placebo. Additionally, we have other additional endpoints, and we'll be looking at the data in its entirety when assessing the outcome of the study. As far as regulatory endpoints, As you know, Natalya Poroshenko, there's no precedent, so this will be discussion with the agency, and that goes through the DERM division. The PBC goes through the GI division, and again, that will be a discussion with the GI division on what the regulatory endpoints would be.
spk11: Got it. I guess my second question is on IV Cursuver. I think somebody had commented on this before, but So if you have any, what's your latest thought process on providing guidance for 2022 for IV Coursera, at least the revenue contribution to CARA? And if you don't think you will provide any guidance in 2020 for the year, I'm curious, you know, how comfortable is management on sort of consensus estimates right now? I think when I look at it, it's around $70 million, but it's a little bit hard to tease out sort of like what's revenue contribution and what is product sales and whatnot. So I'll stop right there.
spk07: No, no, it's a good question. Yeah, yeah, no, it's a good question. Let me turf that to Tom or CFO, talk about guidance, et cetera. Sure.
spk05: Thanks for the question, Chase. So right now, we're not in a position to provide any sales guidance. As Chris mentioned before, we are confident, given the product profile, the concentrated market, and with our strong partner in V4. So we believe Cursiva Injection will have a rapid uptake. We'll continue to work with V4 over the upcoming quarters, and at the appropriate time, based on those discussions, we will give guidance at the appropriate time.
spk11: Got it. And I guess just one more question from me. This is a follow-up, sort of your commentary on sort of management thought process put that up. Certainly appreciate the color that you provide, how, you know, there's similarity and contrast compared to precipice, especially in the precipice setting, precipice has a generic counterpart. So, that's that consideration with the bundle uh adjustment but i'm curious um if i if cursiva were to be bundled after the sub period i would imagine it would be classified into each category and there's already an existing issue category where there's antihistamines such as banadryl already being like taken into account in the the bundle right so you know antihistamine is relatively low cost and it's been you know around a while so i'm just curious how should you know, what's the management thinking process about the bundle rate? Are you thinking about, you know, the differences and how, you know, it classifying into an each category with existing, you know, low-cost alternative, how that might factor into the bundle rate adjustment?
spk07: Right. I mean, it's a great question. So, you know, the post-ADAPTA, as I mentioned before, I mean, You know, we're incredibly optimistic that additional funding will be given to cover course of injection after Tdapa expires over the next two to three years. So, Jason, we, you know, again, we're very confident that there will be funding available. Now, the question is why. Why are we confident? Why are we optimistic? You mentioned that in the pruritus category, in the functional category, There's antihistamines. Well, there's no FDA-approved therapies for pruritus with hemodialysis patients. There are no FDA-approved therapies. So we don't believe that the antihistamines will be included as they look at additional funding for course of injection. I think that's really important. Again, it goes down to the value proposition. And we also know antihistamines have very limited efficacy. in this patient population. It's really the only thing there for them, but it certainly has significant limitations. So net-net post-ADAPA, I mean, we'll work with CMS. They've signaled the willingness to continue to talk to us, which is great, and we'll continue to talk with them. But again, I think the importance for us and V4 is during this ADAPA period is to make sure this drug is accessible and used by as many appropriate patients as possible.
spk11: Got it. Thanks so much. I appreciate all the color you provide. Thank you.
spk08: Thank you. And our next question comes from the line of Daniel Wally with JP Morgan.
spk09: Hi, guys. Thanks for taking our question. You've mentioned underreporting of pruritus by hemodialysis patients as one of the factors, including overlooking by physicians. So I'm trying to see if there's any plans to get to those patients so that they're aware of treatment options, possibly through some sort of DTC campaigns?
spk07: Hey, Daniel, yeah, absolutely. You know, having an informed and activated patient base is a critical, critical lever in the commercialization plan for V4 and CARA, 100%. You know, as I mentioned before, you know, You know, pruritus in the hemodialysis patients, we've done a lot of work with V4. I mean, it's underreported among patients, and it's undertreated. Why? Because there's no treatments. So, you know, the marketing lever that we will pull very heavily with V4 is really activating the patient base.
spk09: Okay. And then, so will you be responsible financially for that type of marketing, or will it be V4 solely?
spk07: No, we don't stand up any commercial organization here at CARA, so V4 will be responsible for the commercialization and the subsequent costs.
spk09: Okay, great. And then just to get a little bit of color on the opportunity for dentology and parasitica, you've outlined in prior presentations the patient opportunity to go around 1 million patients. Of those patients, how many of those have moderate to severe pruritus? and are this potentially addressable by a treatment such as Corsuva?
spk07: Yeah, so, you know, let me tackle it first, and then maybe I'll turn to Joe for a little color commentary. So, you know, we think there's about a million patients that are receiving antipyretic medicines for paritis. You know, in terms of how many would be addressable by us, that's work that we're still doing, to be quite frank. I would estimate itch is the primary concern among these patients. And what we hear is, Daniel, I think you and I spoke before, we call it the itch you can't scratch. And what you see is the use of back scratchers are actually a main treatment that folks use. So we think it's a very, very significant population that would be addressable from an oral course. Again, we've got to see how the data looks in the next quarter, but we're excited about the unmet need there. And, again, I think Joe always says there's no approved therapies in this space, and it's a significant burden of disease on these patients. I don't know, Joe, do you want to say a couple things?
spk06: Yeah, just to add, it was just out there that I think in last year's publication that reported that these patients have about a sixth on NRAs So, you know, it gives you an indication that these patients have moderate to severe itch. And, again, you know, waiting to look at our data, but, you know, potentially a patient population who would do well without drug.
spk09: Great. Thanks again for taking our question.
spk08: You got it, Daniel. Thank you. And as a reminder, to ask a question, you will need to press star 1 on your telephone. Our next question comes from the line of David Amselin with Piper Sandler.
spk02: Thanks. So just have a couple. First, on the commercial landscape for IV Corsuva, can you just talk about the extent to which patients will be getting, say, gabapentin? or other agents, not antihistamines, I should say, but other systemics ahead of IV course. How should we think about that? And then secondly, the CKD study for oral, in terms of the mix between stage 4 and stage 5 CKD, can you just, this is a question for Joe, just talk through the breakdown between the two buckets, how that's going to be, how that's going to play out in the study. And then lastly, just go through whether it's a three-point or four-point worst-itch NRS endpoint. And if you can't talk about it and want to wait until the R&D day, that's fine, but figure I'd ask the question. Thanks.
spk07: Thanks, David. Great hearing from you. So I'll tackle the first one in terms of the treatment algorithm. among patients in hemodialysis that have moderate to severe pariasis. You mentioned gabapentin. I mean, the primary treatment, as you know, is antihistamines predominantly, maybe some topical steroids, but it's predominantly antihistamines. A very small percentage of patients get gabapentin, and you typically have to push the dose there, and that comes with some baggage around side effects sometimes. So even in our studies, CALM 1 and 2, we saw very few patients come in on gabapentin, very few. So we think we're going to slot in very nicely as the standard of care for these patients. That's how we view it. In terms of your second question around CKD, I'll turn that to Jo.
spk06: Thanks, David. But we will wait for those to give further details next week if that's okay. So I'll ask you to be a little bit patient and we'll describe the phase three studies in more detail.
spk02: Okay. Figure it out, ask, but thanks anyway. Thanks, David.
spk08: Thank you. I'm showing no further questions. So with that, I'll turn the call back over to President and CEO Chris Posner for any further remarks.
spk07: Well, thanks a lot, Andrew. And thanks to everyone for joining us today to hear about our great progress heading into this year for CARA. You know, 2022 is going to be a year of, what I say, focused execution. With our partner, V4, really leading the commercialization, we are ready for an efficient, successful launch of course of injection. And we are taking our pipeline to the next level. We hope you join us on March 11th for a virtual R&D event when we will take a deep dive on the details of our Phase III programs with Joe and some leading KOLs. I like to say the future starts now for CARA. So with that, I'll conclude the call and thank everyone.
spk08: Ladies and gentlemen, this concludes today's conference call. Thank you for participating, and you may now disconnect.
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