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 Cara Therapeutics. Ms. Francesconi, you may begin your call. Thank you, Andrew, and good afternoon. Just after market close today, we issued a press release detailing our corporate progress and financial results for the fourth quarter and full year 2021. The 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 Reilly, Cara's Chief Financial Officer, and Joana 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 Korsuva 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 Korsuva Injection, the performance of our commercial partners, including Vifor Pharma, expected timing of the initiation, enrollment, and data readouts from the company's planned 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 Cara Therapeutics' filings with the Securities and Exchange Commission, including the Risk Factors 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. Cara 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. Thanks, Iris, and good afternoon, everyone. With me today are Tom Reilly, our Chief Financial Officer, and Dr. Joana Goncalves, our Chief Medical Officer. Today, I will give you a quick review of our tremendous progress delivering against our milestones, commitments, and plan. I will provide some updates on our preparations for the launch of our first product, Korsuva Injection. Tom will follow with a financial update, and then after that, we'll 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 Cara 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 Cara, 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 pruritus. This guiding mission drives our strategy and our actions. Chronic pruritus 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 Korsuva injection. In 2021, we had a defining moment at Cara. In August, Korsuva 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 Vifor Pharma an exclusive license to commercialize Korsuva injection in the U.S. Vifor 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 Korsuva injection TDAPA 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 Korsuva 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, Vifor Fresenius Medical Care Renal Pharma. In Japan, our partner, Maruishi Pharmaceuticals, recently announced positive phase III study results. Our second strategic priority is to advance our oral Korsuva 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 III 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 Korsuva in other therapeutic areas, including Notalgia Paresthetica and chronic liver disease. Because of its novel mechanism of action, we see oral Korsuva 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 Paresthetica 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 Korsuva injection, and we are excited, and we are prepared for the upcoming early April launch. First and foremost, we have the right partner in Vifor 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 Vifor gives us reach and frequency as well as efficiency and speed. Vifor 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 Korsuva 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 Vifor sales force is trained and engaged to prepare the market for launch. Vifor 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 Korsuva 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. Second, the commercial team has made significant progress on pricing, reimbursement, and access. On pricing, we have set a list price or WAC for Korsuva injection of $150 per vial or roughly $21,000 per patient per year. On reimbursement, TDAPA and the J-code for Korsuva injection are effective April 1. On access, Vifor's account team is actively engaged in formulary discussions with dialysis centers, and we're really confident that Korsuva 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 supply of product to drive a robust launch. We have manufactured sufficient launch quantities of Korsuva 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 Korsuva injection and its launch as a solid step in the validation of our mission and our strategy. Pruritus 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 Korsuva 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 Korsuva injection. Through our partner Vifor, 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 oral Korsuva platform with two pivotal phase III programs for pruritus 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 Korsuva in other therapeutic areas, including notalgia paresthetica 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. 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 $0.63 per basic and diluted share, compared to a net income of $78.9 million or $1.60 per basic and $1.59 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 of Korsuva injection to Vifor. Q4 2020, we recognized $111.6 million related to the license agreement with Vifor and $0.5 million related to the license agreement with VFMCRP. 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 Enteris 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 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 million 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 $88.4 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 VFMCRP. $5 million from Vifor Pharma related to the premium paid by Vifor Pharma for the $50 million equity purchase. We earned $1.9 million in January 2021 from Maruishi related to the initiation of the first phase III trial for uremic pruritus and $0.7 million of commercial supply revenue related to our sales of Korsuva injection to Vifor. For the year ended 2020, we recognized $111.6 million related to the license agreement with Vifor and $22.3 million related to the license agreement with VFMCRP. 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 Enteris during the year ended December 31st, 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, 2021, 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 our former CEO's equity awards in November 2021. In addition, an 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 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 Vifor and VFMCRP upon the FDA approval of Korsuva 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 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. 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. Korsuva injection. We are focused on executing the U.S. launch of our first product in April. We and our partner, Vifor, are prepared. Korsuva 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 Korsuva 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. 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, Korsuva injection, and the profitable economics of our Vifor 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. Andrew, you can now open up the call for questions. Yes, sir. As a reminder, ladies and gentlemen, if you have a question, please press star then one on your telephone. Our first question comes from the line of Joseph Stringer with Needham & Company. Hi, everyone. Thanks for taking our question. 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 comps that we could think about? You know, one in particular that's somewhat of a comp would be Amgen's Parsabiv. Yeah. Certainly some similarities there, but key differences. I was wondering if you could sort of compare and contrast, you know, how you think Korsuva launch could go relative to that drug or any other types of comps that come to mind. Thanks. Yeah. Thanks, Joey. Great hearing from you. 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. I think about this launch in a couple different ways. First, it's a significant condition, and I, 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. 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. 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 J-code, 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. Lastly, most important, it goes down to execution, and we have the right partner in Vifor, which is the leading nephrology company, and they have an established sales force with strong infrastructure. If you think about those, Joey, in terms of the drivers for success, they point to a very strong adoption. The second part of your question was around comps, and you mentioned the Amgen product, Parsabiv. We look at that as probably a good analog during the TDAPA period, but probably not a great analog after the TDAPA period. During the TDAPA period, you know, what we saw with Parsabiv is very strong uptake. You know, it had, I believe, you know, $300 million the first year in 2018 to $550 million the second year, and close to that the third year. A cumulative total of about $1.3 billion in net sales. You know, we feel again that was the only product that ever went through TDAPA. We'll be the second one. Post-TDAPA, you know, obviously there's a lot of differences. That had competition. That had a generic oral equivalent called Sensipar, as well as a branded Sensipar. We'll go into the period after TDAPA, Joseph, with no competition. Again, net-net, the fundamentals of our value proposition remains incredibly strong. 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 a lack of competition and the remaining unmet needs in the space. Great. Thanks for the color. Very helpful, and thanks for taking our question. Thanks, Joey. Thank you. Our next question comes from the line of Chris Howerton with Jefferies. Hi, this is Kambiz on for Chris. Thank you for taking our questions. Team, what does the performance metrics for IV Korsuva launch look like? Are you expecting any pent-up demand for the launch? How do you anticipate COVID-19 impacting the launch? 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 TDAPA implementation in April? Thank you. Hey, Chris. Let me take the last one. The last one first in terms of the, what you said, the lag. When we received TDAPA in December, it's a 90-day implementation period. The CMS has the implementation at April 1. That was via the CMS. That was fully expected. That's the last part of your question. The first part around metrics for success, I believe you asked, and pent-up demand. You know, the great thing, you know, getting an approval last August and what we've seen with Vifor and what we agreed to them, you know, for this preparation period is around strong market shaping. Vifor has been out, you know, really for the last, you know, 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, as well as dialysis organizations. With the proper disease awareness, the market shaping and product shaping that's been underway really for the last 8 months, we feel it's gonna be, again, a very strong launch beginning in April. Thank you. Thank you. Our next question comes from the line of Annabel Samimy with Stifel. Hi, this is Nick Rubino on for Annabel. 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-TDAPA period, should we expect the bundle reimbursement paradigm to cause kind of volume inflections, likely with some level of lower pricing? Shifting to the EU, congrats on the positive CHMP opinion. What should the kind of Kapruvia launch look like? Obviously, Vifor 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? Thanks, Nick. Thanks for the question. The first question is post-TDAPA. This is how we think about post-TDAPA. We think it will be in the bundle, but we think very strongly that it'll be properly funded post-TDAPA. Again, the value proposition of Korsuva injection will remain very strong because if you look at the competition, there is no competition coming. We will be the first and only, and that'll really strengthen as we go through, as more patients get on therapy. We're very optimistic that post-TDAPA funding will be secured. The second question in terms of the EU, we think there's obviously a very large opportunity in the EU. You know, 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 severe pruritus depending on the country. Additionally, I think it's really important, again, we talk about value proposition a lot. There are no approved products to treat CKD pruritus in hemodialysis patients in the EU. There may be some pricing differences clearly between the EU and the U.S., but it's still a very significant opportunity. Great. Just switching to oral Korsuva real quick. Mm-hmm. Congrats on the stage 4/5 expansion. Just wondering if you can kinda give us how you're thinking about powering assumptions for the placebo arm now that it's, you know that it's gonna be stage 4 and 5 inclusion. Are you looking more at the IV Korsuva studies- Mm-hmm. ... to help you think about that or more of the phase II study you did before with stages 3-5? Yeah. Nick, let me turn that over to Jo. Thanks, Nick. As you know, we're gonna be conducting our R&D day next week, and we'll be sharing a lot more about the phase III designs and can give more details at that stage. Makes sense. Hold on. I guess I'll be patient. Thank you. Thanks, Nick. Yeah. Thank you. Our next question comes from the line of Sumant Kulkarni with Canaccord. 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. Hey, Sumant. Great to hear from you. On the price, I mean, in terms of contracting, there is some contracting in the buy and bill space, but it's certainly not as significant as you would typically see in Part D. There will be some contracting, but it's very early to kind of assess what that would look like. In your second question, Sumant, you know, your second question was around peak share. Yeah, I think again, you know, 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. 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. You know, that's how we're kinda thinking about a very strong adoption curve for Korsuva injection. I believe, Sumant, you had a second follow-up. Yes. Yeah, it's more a pipeline-based thing. Is it fair to assume? Yeah, go ahead. that Notalgia Paresthetica remains one of the more relatively challenging CKD-aP 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 pivotal programs in pruritus and atopic dermatitis, for example? Yeah. Let me turn that to Jo. Sure. Thank you. Indeed, Notalgia Paresthetica is quite a challenging itch, and we call it the 22 treatment options and very difficult to manage. There are no currently approved treatments. We are excited about our study and look forward to our data readout in the second quarter of this year. Thanks. Thank you. Our next question comes from the line of Jason Gerberry with Bank of America. Hi, this is Chi for Jason. Thanks for taking the question. I guess the first one. Hey, Jason, I think you're coming in and out. I don't know of your connection. Hi, this is Chi. I'm for Jason. Thanks for taking the question. Oh, Chi. Can you hear me now? I can hear you perfectly. Yeah, go ahead. Yeah. Thank you for taking the questions. I guess first question I have is on the upcoming phase II data readout. Can you talk about high-level the expectation for the readout? I know you had said expecting, looking for separation from placebo at respective studies. Mm-hmm. I'm curious, is it a signal-seeking exercise where you're looking for numeric separation, or are you looking for statistical results for the respective phase II studies? I guess when you look at the primary endpoint for each study, they are looking- Mm-hmm. ... that change from baseline in each score. I'm curious, you know, can we expect any responder analysis from the top-line results similar to- Mm-hmm. ... sort of prior reanalysis of CKD? I guess on that point, would you expect ultimately the registrational endpoint for these indications to be either on responder rates based on either three-point or four-point improvement score similar to sort of like in the CKD and dialysis and similar to the dialysis setting? I guess ultimately, you know, if it has changed from baseline, how should investors interpret the data? Mm-hmm. As they extrapolate into sort of like, you know, what could be a potential registrational endpoint? Sure. Let me, Chi, let me turn that to Jo, and she could address those questions one by one. Sure. Let me first address your first question regarding our expectation. Indeed, these are proof of concept studies as a reminder, we are looking for numerical separation from placebo. Additionally, we have other additional endpoint, and we'll be looking at the data in its entirety when assessing the outcome of the study. As far as regulatory endpoint, as you know, Notalgia Paresthetica because there's no precedent, this will be discussion with the agency. 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. Got it. I guess my second question is on IV Korsuva. I think the company had commented on this before, but if you have any, what's your latest thought process on providing guidance for 2022 for IV Korsuva, at least the revenue contribution to Cara? And if, you know, if you don't think you will provide any guidance in 2024- Mm-hmm. ... for the year, curious, you know, how comfortable is management on sort of consensus estimates right now? I think when I look at it- Mm-hmm. ... 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. I'll stop you there. Right. See how. No, it's a good question. Yeah. Let me turf that to Tom, our CFO, talk about guidance, et cetera. Sure. Thanks for the question, Chi. 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 Vifor. We believe Korsuva injection will have a rapid uptake. We'll continue to work with Vifor over the upcoming quarters, and at the appropriate time, based on those discussions, we will give guidance at the appropriate time. Got it. I guess just one more question from me. May. Sure. This is a follow-up. Sort of your commentary on sort of management thought process on the TDAPA. Certainly appreciate the color that you provide. How, you know, there's similarity and contrast compared to Parsabiv, especially in the post TDAPA setting. Parsabiv has a generic counterpart. Right. There's that consideration with the bundle adjustment. I'm curious if Korsuva were to be bundled after the TDAPA period, I would imagine it would be classified in the ESRD category. There's already an existing ESRD category where there's antihistamines such as Benadryl already being like taken into the bundle rate. Mm-hmm. Mm-hmm. You know, antihistamine is relatively low cost and it's been, you know, around for a while. Mm-hmm. Mm-hmm. Mm-hmm. I'm just curious how should, you know, how what's the management thinking process about the bundle rate? Are you think about you know, the differences and how, you know, it classifying into an each category with existing- Right. Right.... ... you know low cost alternative. Right. How that might factor into the bundle rate adjustment? Right. I mean, it's a great question. You know, the post-TDAPA, as I mentioned before, I mean, you know, we're incredibly optimistic that additional funding will be given to cover Korsuva injection after TDAPA expires over the next two to three years. Chase, we you know, again, we're very confident that there'll be funding available. Now, the question is why? Why are we confident and why are we optimistic? You know, 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. We don't believe that you know, the antihistamines will be included as they look at additional funding for Korsuva injection. I think that's really important. Again, it goes down to the value proposition. We also know antihistamines have very limited efficacy in this patient population. It's really the only thing there for them, but it certainly, you know, has significant limitations. Net-net post TDAPA, I mean, we'll work with CMS. They've signaled the willingness to continue to talk to us, which is great. We'll continue to talk with them, but again, I think the importance for us and Vifor is during this TDAPA period is to make sure this drug is accessible and used by as many appropriate patients as possible. Got it. Thanks so much. Appreciate all the color you provide. Thank you. Thank you. Our next question comes from the line of Daniel Wolle with JP Morgan. Hi, guys. Thanks for taking our question. You've mentioned under-reporting of pruritus by hemodialysis patients as one of the factors, including overlooking by physicians. 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. Hey, Daniel. Yeah, absolutely. You know, having an informed and activated patient base is a critical lever in the commercialization plan for Vifor and Cara. 100%. You know, as I mentioned before, you know, pruritus in the hemodialysis patients, we've done a lot of work with Vifor. I mean, it's under-reported among patients, and it's under-treated. Why? Because there's no treatments. You know, the marketing lever that we will pull very heavily with Vifor is really activating the patient base. Will you be responsible financially for that type of marketing, or will it be Vifor solely? No, we won't. We don't stand up any commercial organization here at Cara. Vifor will be responsible for the commercialization and the subsequent costs. Just to get a little bit of color on the opportunity for Notalgia Paresthetica, you've outlined in prior presentations the patient opportunity is around 1 million patients. Of those patients, how many of those have moderate to severe pruritus, and is this potentially addressable by a treatment such as Korsuva? Yeah. You know, let me tackle it first, and then maybe I'll turn to Jo for a little color commentary. You know, we think there's about 1 million patients that are receiving antipruritic medicines for pruritus. You know, in terms of how many would be addressable by us, that's work that we're still doing, to be quite frank. You know, I would estimate, you know, itch is the primary concern among these patients, and what we hear is, you know, Daniel, I think you and I spoke before, we call it the itch you can't scratch. What you see is, you know, the use of back scratchers are actually a main treatment that folks use. We think it's a very, very significant population that would be addressable from an oral Korsuva. Again, we gotta see how the data looks in the next quarter, but we're excited about the unmet need there. Again, I think Jo always says there's no approved therapies in this space, and it's a significant burden of disease on these patients. Mm-hmm. I don't know, Jo, you wanna say a few words? Yeah, just to add, I think in last year's publication that reported that these patients have about a six on NRS. So, you know, it gives you an indication that these patients have moderate to severe itch. Again, you know, waiting to look at our data. Yeah. You know, potentially a patient population who would do well with our drug possibly. Great. Thanks again for taking our question. You got it, Daniel Wolle. Thank you. As a reminder, to ask a question, you will need to press star one on your telephone. Our next question comes from the line of David Amsellem with Piper Sandler. Thanks. So just have a couple. First, on the commercial landscape for IV Korsuva, can you just talk about the extent to which, you know, patients will be getting, say, gabapentin or other agents, not antihistamines, I should say, but other systemics, ahead of IV Korsuva? How should we think about that? Secondly, the CKD study for oral, in terms of the mix between stage four and stage five CKD, can you just, this is a question for Jo, just talk through the breakdown between the two buckets, how that's going to be, how that's gonna play out in the study. Lastly, just go through whether it's a three-point or four-point worst itch NRS endpoint. If you can't talk about it and wanna wait till the R&D day, that's fine, but figure I'd ask the question. Thanks. Thanks, David. Great hearing from you. I'll tackle the first one. In terms of the treatment algorithm, among patients in hemodialysis that have moderate severe pruritus, 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, you know, some baggage around side effects. You know, even in our studies KALM-1 and KALM-2, we saw very few patients come in on gabapentin, very few. We think we're gonna 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. Mm-hmm. Thanks, David. We will wait for those to give further details next week, if that's okay. I ask you to be a little bit patient, and we'll describe the phase III studies in more detail. Okay. Figure I'd ask, but thanks anyway. Thanks, David. Thank you. I'm showing no further questions. With that, I'll turn the call back over to President and CEO, Christopher Posner, for any further remarks. Well, thanks a lot, Andrew. Thanks to everyone for joining us today to hear about our great progress heading into this year for Cara. You know, 2022 is gonna be a year of, what I say, focused execution. With our partner, Vifor, really leading the commercialization, we are ready for an efficient, successful launch of Korsuva injection. We are taking our pipeline to the next level. We hope you join us on March 11th for our virtual R&D event, when we will take a deep dive on the details of our phase III programs with Jo and some leading KOLs. I like to say the future starts now for Cara. With that, I'll conclude the call and thank everyone. Ladies and gentlemen, this concludes today's conference call. Thank you for participating, and you may now disconnect.