Good afternoon. My name is Shannon, and I will be your conference facilitator. I would like to welcome everyone to the Cara Therapeutics Third Quarter 2022 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 one on your telephone keypad. Please be advised that this call is being recorded. I would now like to introduce Matt Murphy, Cara's Manager of Investor Relations. Mr. Murphy, you may begin your call. Thank you, operator, and good afternoon. Just after market close today, Cara issued a news release announcing the company's results for the third quarter of 2022. Copies of this news release and SEC filings can be found in the investor section of our website at www.caratherapeutics.com. Before we begin, I would like to remind you that during the course of this conference call, we will be making certain forward-looking statements about Cara and our programs based on management's current plans and expectations. These statements are being made under the Private Securities Litigation Reform Act of 1995, and they are subject to various risks and uncertainties. Actual results may differ materially due to various factors, and Cara is under no duty to update these statements publicly. Investors should read the risk factors set forth in Cara's 10-K for the year ended December 31, 2021, and the 10-Q for the quarter ended September 30, 2022, and any subsequent reports filed with the SEC. With that said, I'd like to turn the call over to Chris Posner, Cara's Chief Executive Officer. Chris? Thanks, Matt, and good afternoon, everyone. The third quarter was about traction for Cara, where strong execution on our strategy has started to propel us on the road to accelerated growth for years to come. We believe our goal to become the world leader in Pruritus has a unique long-term value proposition. Our clear focus is to provide potential solutions to this underserved condition affecting millions across many disease areas. As we gain strategic momentum, this focus is a differentiating factor. The third quarter showed that the pieces are in place for near-term and long-term success of our strategy. Demand for KORSUVA injection is accelerating as we anticipated. We are quickly expanding internationally with the launch of KORSUVA and KAPRUVIA in countries around the world. Our rapidly advancing oral difelikefalin pipeline presents the opportunity to build sizable franchises in nephrology and dermatology. We are pleased with the launch progress for KORSUVA injection in the third quarter. Net sales for KORSUVA injection were $16.2 million. Cara's profit-sharing revenue was $7.4 million. Demand jumped 100-fold to over 180,000 vials shipped from wholesalers to clinics. Product demand is the key to KORSUVA's injection momentum and how it builds towards a successful franchise. The significant quarter-to-quarter acceleration in demand is the result of continued strong execution from the CSL Vifor and Fresenius field forces. It also reflects the underlying strong value proposition of KORSUVA injection for the appropriate dialysis patients. As we outlined last quarter, large dialysis organizations are the key drivers of long-term sustainable demand. In the third quarter, most of the demand acceleration did come from the LDOs, primarily from Fresenius. For some extra color, almost all Fresenius Medical Care clinics placed an order by the end of the quarter, and we are closely monitoring reorder rates to understand the number of patients starts in all clinics. DaVita's product has been more gradual, which we expected based on similar prior launches in this space. Nevertheless, there is positive momentum. We have seen more than half of the DaVita clinics who have previously ordered KORSUVA reorder. Moreover, we are seeing continued growth at midsize and independent dialysis organizations with high penetration and solid reorder rates. Positive anecdotal market feedback keeps rolling in across our stakeholder groups. Patients, caregivers, medical providers, and our launch partner, CSL Vifor, have relayed very encouraging comments on the clinical benefit from KORSUVA injection. Driving all of this is the continued strong market engagement. In the third quarter, CSL Vifor launched a comprehensive CKD Pruritus awareness program in conjunction with the National Kidney Foundation that includes a CKD associated Pruritus webpage, infographics, fact sheets, patient testimonials, and a Facebook Live event. This is on the heels of the CKD associated Pruritus awareness programs with the American Kidney Fund and the American Association of Kidney Patients, which were launched in the second quarter. In early October, CSL Vifor conducted a large symposium at the 2022 American Nephrology Nurses Association fall meeting. Recently, CSL Vifor had a significant presence at the American Society of Nephrology annual meeting with multiple initiatives targeting patients and providers, including a new patient campaign. Overall, after the second full quarter into the U.S. launch, we see significant progress and momentum driven by the acceleration of product demand. This is the essence of any successful product launch. We are still early in this launch, and we continue to expect demand and wholesaler shipments to normalize over the coming quarters with some potential quarter-over-quarter variability in the process. Keeping the big picture in view, the KORSUVA injection launch is on its way, and we are very pleased with how it's progressing. Internationally, Cara Therapeutics has made significant strides in making KORSUVA available globally. In the EU, the KAPRUVIA launch has started with Germany leading the rollout across the continent. Germany has also updated its clinical guidelines to include KAPRUVIA as a first-line option for the treatment of Pruritus in chronic kidney disease. We are pleased with this positive development at the start of the launch. KAPRUVIA's launch has also commenced in Austria. We expect the majority of the EU countries to launch in 2023. Our product was also approved in Q3 under the name KORSUVA in Canada and KAPRUVIA in Singapore and Switzerland, and we expect approval in the last Access Consortium country, Australia, in the coming months. In Japan, our partner, Maruishi Pharmaceutical, recently announced filing for approval with the PMDA. We expect a decision on this application in the second half of 2023. Moving on to our pipeline. We are making great progress in our strategic priority of expanding the utility of oral difelikefalin. We are enrolling patients in our ongoing phase III clinical trials in Pruritus associated with advanced chronic kidney disease and atopic dermatitis. We continue to expect reporting top-line data for the CKD program in the second half of 2024, and we are still on target for the internal readout of Part A of the phase III AD study in the second half of 2023. We recently presented exciting additional data for oral difelikefalin in notalgia paresthetica. The late-breaker presentation at the EADV Congress in Milan highlighted difelikefalin's rapid onset of action, which occurred as early as day one, and its sustained effect throughout the active extension phase to week 12. We have a meeting scheduled with the FDA this quarter to discuss the steps to a pivotal clinical trial program in NP, and we look forward to providing an update on the program in the future when appropriate. Finally, on to our 16-week proof of concept trial in Pruritus associated with PBC. Given the continued slow enrollment, we made a strategic decision to discontinue the study and unblind the data. The small number of patients limits the interpretability of the data. However, efficacy was trending in the right direction, and there were no new safety signals. It is important to note that the data do not preclude us from pursuing this indication at a later date. With the potential of NP advancing toward a pivotal program, at this time, we are focusing our resources on building our dermatology franchise and expanding our nephrology franchise. We have significant opportunities in both therapeutic areas, and we are pleased with the progress we have made to date. In conclusion, we believe that this quarter has shown that we are continuing to build momentum. We are gaining traction in our strategy to drive long-term growth for Cara and create value for our shareholders. This was evident three ways this quarter. Product demand is accelerating for KORSUVA injection. We are rapidly moving toward becoming a world leader in Pruritus, and we are laser-focused on maximizing the potential of oral difelikefalin in nephrology and dermatology. Now, I'd like to introduce Ryan Maynard, our new Chief Financial Officer, for his first quarterly earnings call with Cara. Ryan will provide details on our third quarter results, and we'll all be available for your questions after that. Over to you, Ryan. Thank you, Chris. I'm happy to be a part of this amazing team at this very exciting time in Cara's growth story. Now on to the Q3 results. As a reminder, the full financial results for the third quarter of 2022 can be found in our press release issued today after the market closed. Total revenue was $10.8 million for the three months ended September 30, 2022, compared to $20.3 million for the same period in 2021. Revenue this quarter consisted of $7.4 million of collaboration revenue related to the profit-sharing revenue from CSL Vifor's sale of KORSUVA injection to third parties and $3.4 million of commercial supply revenue. Revenue of $20.3 million in the comparable period of 2021 related to certain milestone payments associated with the regulatory approval of KORSUVA injection. Cost of goods sold during the three months ended September 30, 2022 was $3.1 million and relates to our commercial supply shipments in the quarter to CSL Vifor. R&D expenses were $24.7 million for the three months ended September 30, 2022, compared to $15.5 million in the same period of 2021. The increase in R&D expenses is due to the combination of the increased clinical trial spend related to our two phase III clinical programs and the recognition of a $5 million milestone payment due to Enteris. G&A expenses were $6.9 million for the three months ended September 30, 2022, compared to $5.9 million in the same period of 2021. The higher G&A expenses for the three months ended September 30, 2022, were primarily due to increased headcount-related costs as we look to build out the key function to support Cara's growth. Cash and cash equivalents, and marketable securities at September 30, 2022, totaled $179.5 million, compared to $236.8 million on December 31, 2021. The decrease in balance primarily resulted from $57.3 million of cash used in operating activities. Finally, we expect that our current unrestricted cash and cash equivalents and available-for-sale marketable securities are sufficient to fund our currently anticipated operating plan into the first half of 2024. This runway guidance now assumes a KORSUVA revenue profit share contribution going forward, consistent with the levels we have reported for this quarter. I'd like to point out that this is not our forecast for forward-looking KORSUVA revenue, but rather a conservative runway outlook. I will now turn the call back over to Chris. Thanks, Ryan. With that, Ryan, Jo, and I will be happy to take your questions. Shannon, you can now open up the call for questions. Thank you. As a reminder, to ask a question, you will need to press star one one on your telephone. Please stand by while we compile the Q&A roster. Our first question comes from the line of Sumant Kulkarni with Canaccord Genuity. Your line is now open. Good afternoon, thanks for taking my questions. I have a couple. The first one is a clarification on the 184,000 or so vials that were shipped in the third quarter. Is that a U.S. only number? If it's worldwide, what would the U.S. only fraction be? My second question is on atopic dermatitis. When you get the internal readout for KIND-1 Part A in the second half of 2023, what do you expect to communicate to The Street on that? Hey, Sumant, it's Chris. On your first question, the 184,000 vials is U.S. only. That's shipments from the wholesalers to the dialysis clinics in the U.S. On the second question on AD, let me turn that to Jo. Hi, Sumant. Yes, for atopic dermatitis, two things we'll be sharing. One will be the sample size, and the second will be the dose selected going into Part B and the second pivotal study. Got it. Thanks, I'll hop back in the queue. Thank you. Our next question comes from the line of Joseph Stringer with Needham & Company. Your line is now open. Well, hi, thanks for taking our questions. Two from us. One on sort of margins here. Looks like the 3Q 2022 margins came in very similar to what the 2Q margins were. Just curious if you think this was again in line with expectations and do you expect this to continue going forward? Then the second question is on the addition of the Fresenius sales force. Were all of those that sales force added in 3Q, or are there some additional impact from that coming online in the fourth quarter and beyond? Yeah. Hey, Jo, it's Chris. Let me answer the last question and then I'll turn it to Ryan. He can talk about the margins real quick. On your last question, the Fresenius Renal sales force really came online in the beginning of the third quarter. This is reflective. The numbers I mentioned are reflective of the Fresenius sales force in the third quarter. On margins, Ryan, do you wanna- Ya so this is Ryan. You are correct, and the margins are very consistent this quarter from last, and I would expect that would continue, going forward. Great. Thanks for taking my questions. Thank you. Our next question comes from the line of Daniel Wolle with J.P. Morgan. Your line is now open. Hi, guys. Thanks for taking our question. Just a clarifying question. How much of the $7.4 million revenue is driven by the 184,000 vials representing true user demand versus stocking? Given prior remarks that the 4Q demand should represent the biggest change from what was observed in 2Q in net user demand, and looking at the reported numbers today, how should we think about fourth quarter revenue? Then last, should we expect full year guidance to be provided for 2023? Hey, Daniel, it's Chris. Let me give question one and three to Ryan. Three is the guidance, Ryan. Yeah. So Daniel, thanks for your question. This is Ryan. It's important to note that that $7.4 million of revenue is shipments from Vifor to wholesalers. That is not the $180,000 that you're talking about, which is wholesalers to clinics. That's the important first piece. As far as full year guidance for revenue for KORSUVA, we're not yet at the stage. We're at the early innings. We're in the second quarter of what we're reporting on the second quarter of launch, and we're not gonna give full year KORSUVA revenue guidance. We did, as you see, give guidance on our runway, which I thought was important to come off of the very conservative guidance we gave in Q2, which is to include zero KORSUVA revenue. I thought that was gonna be prudent and helpful. I'll turn it back to Chris for the second question. Yeah, Daniel, you know, I said in the quarterly, the 2Q quarterly call, my focus, our focus is really on demand, on demand generation. That's true kind of in any launch I've ever been a part of. That's gonna be the focus in 4Q. We're really pleased with the acceleration in Q3 in demand that primarily came from Fresenius, as I mentioned, but also we saw a good acceleration in the MDOs, IDOs and again, a gradual pickup in DaVita. In the fourth quarter, our eyes are gonna be on demand as well. We're going to look closely to see how the product's getting pulled through at Fresenius and continued uptake at DaVita. I would fully expect this acceleration to continue. Thank you. Thank you. Our next question comes from the line of Jason Gerberry with Bank of America. Your line is now open. Hi, this is Chi in for Jason. Thanks for taking the questions. I have two. First one on the gross-to-net. I'm curious if you can comment on gross-to-net on IV KORSUVA. Trying to make sense of the 184,000 vials shipped from wholesalers to dialysis centers. I understand that that's not where the sales are recognized, but you know, am I roughly right if I think about a $150 list price per vial if you account for gross-to-net, is it around $20 million dollar shipment? Am I roughly in the ballpark? If you can comment on that'll be helpful. The second question is on your penetration in DaVita centers. Appreciate all the colors that you provide that, you know, you have a lot of orders from primarily Fresenius. Almost all the centers there order in 3Q. If you can give a little flavor on sort of your penetration in DaVita, what proportion of DaVita centers ordered IV KORSUVA in 3Q, and how do you see that, you know, what would be the main driver to get additional IV KORSUVA in DaVita dialysis centers? That would be helpful. Thank you. Yeah, certainly, Chi. Let me pass on the gross-to-net to Ryan, and I'll come back and address the DaVita. Hey, Chi. Ryan here again. I understand it takes a little bit of clarification. The gross-to-net that we report and is all that we will report is shipments from Vifor to wholesalers. We're not gonna get into the gross-to-net related to the 180,000 vials that were shipped to the dialysis organizations. The math that you are attempting to do, you can't do based on what we've reported. I hope that's helpful. Yeah. Chi, on DaVita, you know, I mentioned in my prepared remarks that we have seen a major acceleration in customer ramp-up, and that was primarily in the Fresenius clinics. Also we saw strong acceleration across the other providers, including DaVita. Specific to DaVita, you know, they tend to adopt new products and bring in new products and protocols more gradually. We expect that ramp-up to continually gain steam, and we've seen an increase in the number of DaVita clinics ordering and as I mentioned, fully expect this to continue. I'd also point out, you know, that KORSUVA is on formulary at DaVita, and they do have protocols in place. I'd also point out that CSL Vifor, even though they have a very unique and special relationship with Fresenius, they also have a very strong relationship with DaVita, selling them their portfolio of dialysis products. They even mentioned on their call, CSL Vifor's call, they actually just signed a recent deal on an erythropoietin for treatment of anemia with DaVita. You know, net-net, we're really confident that DaVita is gonna continue to gradually adopt this product and bring it in for their patients. Great. Thank you. You're welcome. Thank you. Our next question comes from the line of Chris Howerton with Jefferies. Your line is now open. Hi, y'all. First question for me, this is A.J., by the way, is just a clarification on the DaVita versus Fresenius sales. Is there a difference between that you've observed between the vials shipped to DaVita versus Fresenius at the time? Yeah. Hey, A.J.. I mentioned that the third quarter, the bulk of the demand really was in the Fresenius clinics, with also you know kind of acceleration in the MDOs, IDOs and to a lesser extent, DaVita. That's kind of the you know double click on demand, if you will, in the third quarter. Gotcha. A.J., I think you cut off. There you go. Oh, okay. Sorry about that. That's all right. I have one more after this. Sure. on the commercial supply revenue. How should we be thinking about the long-term steady state of inventory? You know, will it draw down over time or will it, you know, kind of, equalize or, yeah, how should we think about that? Sure. Ryan, go ahead. Yeah. Hi, A.J., Ryan here again. Yeah, it is definitely lumpy. I recognize that. Keep in mind that this is. an agreement between us and Vifor that is focused solely on the manufacturing of the product and shipping it to Vifor. The timing of which relates mainly to how it moves through the batch and the manufacturing and less with demand. I'm not gonna comment on how it's being manufactured, and I understand it's lumpy, but you can probably expect a little lumpiness going forward. Okay. That helps with expectations. My last question is, are there any additional efforts by Cara and not just CSL Vifor to promote the awareness and advocacy program? Yeah, A.J., I mean, CSL Vifor is our commercial partner. So, you know, we're not expending dollars to launch this product. This is on CSL Vifor and, you know, quite frankly, they are an exceptional partner with exceptional market intimacy in nephrology. You know, you can see the results. They're doing a really good job as we move two quarters into launch. Remember, A.J., and you and I have talked before, we're building a market, and there's nobody better to build a market than somebody with that intimate know-how in the nephrology dialysis space than CSL Vifor. Then we added on, obviously, the Fresenius sales force, and that's a contract between CSL Vifor and Fresenius. We're actually incredibly pleased with the dedication of CSL Vifor and Fresenius to building this market, and we're really starting to see the results two quarters in. Okay. Maybe more directly, would you consider advertising? CSL Vifor is doing the advertising. Gotcha. All right. Thanks all. Yep. Thank you. Our next question comes from the line of Staci Lee with Stifel. Your line is now open. Hi, this is Staci calling in for Annabel. Congrats on the great quarter. Just two questions on our end. Realizing that you book revenues when you ship to wholesalers and then vials sold is when dialysis providers order from the wholesalers, is there a point when these two figures will square up? Secondly, at what point will we have more clarity on the proposal that CMS made regarding the post-TDAPA period for innovative drugs? You know, what are the next steps that need to occur and the timeline before we see a change in the mechanism there? Yeah. Hey, Staci. So in terms of kind of the trade inventory and demand, I would expect to see some variability still. You know, Ryan likes to say lumpiness over the next few quarters, and that's pretty typical in any launch. I would expect that to start to normalize as we head into 2023. Can't give an exact date, but I would expect that to you know settle down and kind of more equate in 2023. CMS, it's a great question. You know, CMS came out with their final rule last week or two weeks ago, and they did not address the comments in the RFI in the final rule. What they did do, though, is they acknowledged the comments and indicated they're gonna consider them as they consider possible future rulemaking to address post-TDAPA reimbursement for innovative drugs. So, you know, what we expect is to hear something probably more, more in the final rule for 2024, which would be this time kind of next year. That's our expectation. That's what we expected even with this rulemaking cycle. I'd also say, Staci, as well, you know, we, Cara, CSL Vifor and other key stakeholders, will continue to be in contact with CMS and doing lobbying efforts, et cetera. I feel very strongly that CMS really has an open mind here. They understand that it's important that there is resolution before KORSUVA comes out of this TDAPA period in 2024. We're really hopeful that more clarity will come as part of the 2024 rulemaking cycle. Amazing. That was really helpful. Thank you, guys. Thanks, Staci. Thank you. Our next question comes from the line of David Amsellem with Piper Sandler. Your line is now open. Hey, thanks. Just a couple. Just a clarification question. Will 4Q revenues sort of look more like an approximation of demand, or is it going to be, is there still gonna be some real inventory in there, just given that we're still in the early stages of the launch? Just wanted to get a sense for, you know, what 4Q may or may not look like, vis-a-vis inventory. I think that would be helpful. Secondly, you mentioned earlier, Chris, about DaVita and, you know, how uptake tends to be, ordering a new product in general tends to be more gradual, if you will. Just wanted to get a sense from you as to, you know, why that is. You know, why is DaVita's uptake tend to be slower. Is it anything specific to KORSUVA? Is it just sort of a general standard operating procedure? That would be helpful. Thanks. Yeah, David. Nice to hear from you. Your first question around expectations for Q4, you know, obviously we're not gonna give forward-looking guidance. You know, I would still expect there to be, you know, again, Ryan's word, lumpiness in terms of trade inventory and demand. What I'm looking at is a continued ramp-up in demand. That's what's critical. As I just mentioned to the previous question from Staci, is that I would expect that to start to normalize sometime next year. That's pretty typical when you're building a market and you know, people are taking on product. Your last question on DaVita. Yeah, you know, David, it is a gradual adoption. We saw it with Parsabiv. You know, in terms of rationale, I mean, just that organization tends to bring on a product more gradually, to get experience, adjust their algorithms appropriately. It's not specific to KORSUVA. Also, to be clear, you know, DaVita doesn't have a sales force like Fresenius as well, so that's another important lever in terms of more rapid uptake that we're seeing at Fresenius. I would also point out though, which is significant, is that we are seeing a good pickup in DaVita, right? We are seeing clinics coming on board week to week, and we are seeing those that are coming on board actually having a very strong reorder rate. We actually feel really good about where we are in meeting our expectations from the DaVita organization, and we're really excited about kind of the quarters to come. Great. Thank you. You're welcome. Thank you. As a reminder, to ask a question at this time, please press star one one on your touchtone telephone. Our next question is a follow-up from Sumant Kulkarni with Canaccord Genuity. Your line is now open. Oh, thanks so much for the follow-up. This question is independent of the rulemaking process where we have some timelines to look forward to. What is the latest thought process on how this quarter's vials are trending relative to setting a good utilization rate when TDAPA ends? If this is still a premature question, how many quarters do you think we'll need to see vials for to get a better run rate on this variable that's key for reimbursability post TDAPA? Yeah, Sumant, you know, again, a super question and on the CMS in terms of how they look at utilization. I mean, listen, we're building market. We're two quarters in. Really, if you think about the LDOs really just came on board in the third quarter, namely, you know, with a strong acceleration of Fresenius. You know, I would fully expect utilization, you know, obviously to continue to ramp up. As we near the end of TDAPA, I think we're gonna have a really good, you know, really good sense of what sort of patient population we have on KORSUVA that will help CMS in terms of their estimation of potential funding, either through, you know, kind of the rulemaking cycle, potential add-on payment, or within the bundle itself. You know, and you know, Sumant, I'll just conclude too. They typically look at the full two years of utilization, and we saw with Parsabiv, I think it was really important there was an additional year added on to TDAPA to get a good, steady state two years of utilization data to calculate the funding. Got it. Thank you. You got it. Thank you. I'm currently showing no further questions at this time. I'll now turn the call back over to the Cara team for closing remarks. Yeah. Thank you, Shannon. Really thank you everyone for joining our quarterly call. We're really excited about where we are as a company in terms of adding both short-term and long-term value, and we'll continue to focus on execution with our partner, with IV KORSUVA, and under Jo's leadership, you know, continue to execute our clinical trial programs. With that, I'll conclude the call. Thank you. This concludes today's conference call. Thank you for your participation. You may now disconnect.