Good afternoon. My name is Lateef, and I will be your conference facilitator. I would like to welcome everyone to the Cara Therapeutics First Quarter 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. To remove your name from the queue, simply press star and the number one one again. 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, good afternoon. After market closed today, Cara issued a news release announcing the Company's financial and operating results for the first quarter of 2023. Copies of this news release and the associated SEC filing can be found in the Investor section of our website at www.caratherapeutics.com. Before we begin, let me 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 are subject to risks and uncertainties. Actual results may differ materially due to various factors, and Cara undertakes no obligation to update or revise these statements publicly as a result of new information or future results or developments. Investors should read the risk factors set forth in Cara's 10-K for the year ended December 31st, 2022, and any subsequent reports filed with the SEC, including its Form 10-Q for the quarter ended March 31st, 2023. With that said, I'd like to turn the call over to Chris Posner, Cara's Chief Executive Officer. Chris? Thanks, Matt. Good afternoon, everyone, and thank you for joining our call. With me today are Ryan Maynard, our Chief Financial Officer, and Dr. Joana Goncalves, our Chief Medical Officer. I'd like to start by giving a quick overview of what I'll address today. For the update on the KORSUVA injection launch in the U.S., I will provide additional metrics that we are tracking to give better insight into the progress of demand and uptake. These will help to give some clarity and show the opportunity within the different customers and segments of the market. I will also review the launch progress in countries around the world. I will highlight our robust clinical stage pipeline and the advancement of our high-value development programs for oral difelikefalin. I am pleased with the progress to date and can confirm that we continue to track to our previously communicated timelines. After that, Ryan will provide you with a financial update, and then we will open up the call to Q&A. I will begin with the launch of KORSUVA injection in the U.S. For the first quarter of 2023, net sales for KORSUVA were $5.7 million, translating into $2.8 million of profit recorded as revenue to us. Wholesaler shipments to dialysis clinics more than doubled quarter-over-quarter and reached 46,000 vials. 64% of these vials were shipped to Fresenius or FMC clinics, with the remainder split between DaVita and the other dialysis organizations. This increase in vial shipments suggests a meaningful acceleration in demand. Anecdotal feedback on KORSUVA from both providers and patients continues to be highly positive, supporting this expansion in breadth and depth in its utilization. At FMC, orders more than tripled quarter-to-quarter, reaching 30,000 vials. By the end of the first quarter, 500 FMC clinics, or 18%, had placed reorders, up from 7% of clinics at the end of Q4. More importantly, 1,500 clinics or 56% of FMC clinics had dosed at least one patient, up from 29% of clinics at the end of Q4. Total patient demand remains difficult to assess without specific information about the levels of inventory remaining at individual clinics. However, we continue to see significant growth in the number of FMC clinics exhausting their third quarter 2022 bolus inventory and expect that the majority of the FMC clinics will be in a reorder mode in the second half of this year. At DaVita, demand growth continues to be steady. At the end of first quarter, 300 clinics or 11% of DaVita clinics had ordered KORSUVA, that's up from 7% of clinics at the end of Q4. Reorder rates among these clinics remain very encouraging, with 70% placing repeat orders. Given the on-demand approach at DaVita clinics for ordering KORSUVA, the growth in clinic orders represents a good proxy for the growth in patient demand. At midsize and independent DOs, KORSUVA continues to perform well. At the end of the first quarter, 13% of these clinics had placed orders, that's up from 11% at the end of Q4. In addition, 66% of these clinics have placed repeat orders. The strongest performance to date amongst this group has been at USRC, that's the largest of the mid-size DOs. Roughly 66% of clinics have ordered KORSUVA, and 72% of these clinics have placed repeat orders. Stepping back and looking at the big picture, KORSUVA's overall market penetration leaves significant room for growth, with a vast majority of the market still untapped. To get there, CSL Vifor continues to make progress building the market, navigating the idiosyncrasies of each segment across the entire DO landscape. This is reflected in key trends this quarter. Clinic orders doubled quarter-to-quarter. Almost 60% of FMC clinics are dosing a patient, and each segment is seeing an increase in clinics ordering the product. We remain confident, and our partner, CSL Vifor, remains fully dedicated to capturing the latent upside in this market and maximizing the commercial potential of KORSUVA in the long term. We are working in close collaboration with the kidney community to help CMS understand the need for a durable and appropriate reimbursement mechanism for TDAPA-designated products post their TDAPA period. We remain confident that additional funding will be made available for TDAPA-designated products, and we remain hopeful that a substantive and positive update will be released during this year's rulemaking cycle. On the international front, the rollout of Kapruvia in Europe continues to gain momentum. In the first quarter, Kapruvia generated $1.2 million in net sales, translated into $125,000 of royalty revenues to us. Rollout has begun in four additional countries: France, Finland, the Netherlands, and Switzerland, bringing the total number of launch countries to seven. The initial feedback from patients and providers has been very encouraging and in line with the patient testimonials we have received in the U.S. We continue to expect the additional countries in Europe and other countries around the world to come online throughout the next 12, 18 months once reimbursement is secured. Also, a decision from the U.K. National Institute for Health and Care Excellence, or NICE, is expected imminently. In Japan, we continue to expect a regulatory decision in the second half of 2023. As a reminder, approval in Japan would trigger a $2 million milestone payment to Cara. Last, but certainly not least, I'd like to briefly discuss our promising wholly owned oral pipeline. Fundamentally, Cara is a development company, and we are committed to building our nephrology and medical dermatology franchises with oral difelikefalin. These efforts will drive us to our goal of being a differentiated company as the world leader in treating chronic pruritus in the long run. Enrollment in our phase III programs in pruritus associated with advanced chronic kidney disease and in atopic dermatitis is progressing as expected. We anticipate the internal readout of Part A of our KIND 1 AD trial in the 4th quarter of this year, with final top-line results from this program in the first half 2025. We also continue to expect top-line results for our KICK advanced chronic kidney disease program in the second half of 2024. Startup activities for our phase II/III program in notalgia paresthetica kicked off in the 1st quarter of this year, and they are progressing well. The NP program is tracking to the internal readout of KOURAGE-1 Part A in the second half of 2024 and final top-line results for the program in the first half of 2026. To summarize, we are continuing to work closely with CSL Vifor to accelerate the uptake of KORSUVA, we remain confident that these efforts will drive near-term growth. Additionally, we remain optimistic regarding CMS's future decision on the post-TDAPA funding mechanism and hope to see an update during this year's rulemaking cycle. Underscored by the highly positive feedback we are hearing from patients and providers around the world, we continue to believe in the long-term success of KORSUVA injection. More importantly, we see tremendous value creation for Cara with our three late-stage programs with oral difelikefalin. We are fully committed to advancing these programs as rapidly as possible in order to maximize the potential of difelikefalin within our two therapeutic franchises. We look forward to providing you with updates on our progress throughout this year. Now, I'd like to turn the call over to Ryan for additional details on our first quarter financial results. Over to you, Ryan. Thank you, Chris. Total revenue was $6.2 million for the three months ended March 31st, 2023, compared to $4.8 million for the same period in 2022. Revenue this quarter consisted of $2.8 million of collaborative revenue related to our profit from CSL Vifor's net sales of KORSUVA injection to third parties and $3.2 million of commercial supply revenue. We also recognized $125,000 of royalty revenue this quarter, representing our royalties from the net sales of Kapruvia in the first quarter of 2023. Cost of goods sold during the three months ended March 31st, 2023 was $2.6 million and relates to our commercial supply shipments of KORSUVA injection to CSL Vifor. Research and development expenses were $24.3 million for the three months ended March 31st, 2023, compared to $21.3 million in the same period of 2022. The increase in R&D expenses is primarily due to the increased clinical spend related to our three late-stage clinical programs. General administrative expenses were $6.9 million for the three months ended March 31st, 2023, compared to $9.4 million in the same period of 2022. The reduction in GA expense was due to a decrease in stock-based compensation in the first quarter of 2023 as compared to the same period in 2022. Stock-based compensation in 2022 included costs related to the modification of certain equity awards to our former CEO. Cash, cash equivalents, and marketable securities at March 31st, 2023 totaled $123.4 million, compared to $156.7 million at December 31st, 2022. The decrease in the balance primarily resulted from cash used in our operating activities. 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 second half of 2024. This guidance assumes all the spend related to our three late-stage clinical development programs and KORSUVA revenue profit share contribution. Finally, I'd like to highlight for everyone that we are exploring certain non-dilutive financing opportunities to extend our runway further. I will now turn the call back over to Chris. Thanks, Ryan. I want to reiterate that we are laser-focused on making the KORSUVA injection launch a success, and additionally, we remain confident in the massive potential of our pipeline behind oral difelikefalin. We have full confidence that our long-term strategy will help us achieve our goal of becoming the world leader in the treatment of chronic pruritus and ultimately delivering significant value to our shareholders. With that, Ryan, Joana and I will be happy to take your questions. Lateef, let's open up the line for Q&A. 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 Joseph Stringer of Needham & Company. Please go ahead, Joseph. Hi, thanks for taking our questions. Just two for us. Do you have any visibility into the inventory in the clinics? Was that something that's still opaque, and would you ever gain visibility into this? Secondly, is on the inventory levels at the wholesalers. Can you remind us again what that is just in terms of, you know, the inventory levels at wholesalers, and do you expect that to remain relatively constant as the launch progresses here? Thank you. Hey, Joseph, nice hearing you. Let me tackle both of those. The first is around inventory at the Fresenius level. You know, one of the things that we wanted to really focus on this quarter, and we and CSL, you know, knew we needed to provide additional metrics or key performance indicators to give more clarity on uptake demand and really opportunity in the market. And we felt it was particularly important with FMC and how its clinics were working through its existing inventory. The metrics that we're providing around, A, penetration rate, you know, and that's what I mentioned, you know, roughly 1,500 clinics are actually dosing a patient at Fresenius. That's the best insight we have to how product is being utilized at a clinic level. We don't have specific insight into how much inventory is still remaining, but that gives you a good sense of how many clinics are using the product. Then you couple that with the second critical metric, and that's reorder rates. And here, you know, what's important there is that, you know, that shows how many clinics that have dosed a patient now are becoming recurring customers. For Fresenius, that metric's particularly important because they've exhausted their inventory, and that metric is actually 500 clinics. That's up from, you know, that's up from roughly 200 clinics in the end of Q4. You know, we're really encouraged about the drawdown in inventory, and I think the punchline there is that we believe by mid-year, you know, the majority of FMC clinics will have exhausted their inventory and really be in that reorder mode. To your second question, Joey, around inventory at the wholesaler level, you know, it's pretty standard. You know, I don't know the specific contract between CSL and their wholesalers, but, you know, it's not really that atypical, you know, versus other traditional markets. You know, it could be a couple weeks Okay, great. Thanks for taking our questions. Thank you. Please hold for our next question. Our next question comes from the line of Annabel Samimy of Stifel. Your question, please, Annabel. Hi, guys. Thanks for taking my questions and for the progress. I just want to drill down on your comment that you're considering efforts to accelerate uptake. Do you have any specific tools that you're working with to be able to do that with Fresenius before? I guess that's the first question. I'll follow up with some others. Yeah, Annabel. I mean, you know, CSL Vifor is doing a really nice job of really working the entire, you know, top down, bottom up stakeholder base. You know, they have a series of tactics that they've employed, you know, from peer-to-peer programs to direct-to-patient initiatives. You know, I'd also mention at Fresenius, right? I mean, the Fresenius sales force is actually engaged as well, and they've deployed their sales force to activate the clinics and really drive utilization. You know, the punchline there is that we're seeing increases in, you know, the number of clinics, you know, actually starting patients on therapy. That's now 1,500, and that's up quite significantly versus Q4. We're seeing a number of those clinics at Fresenius, you know, draw down that inventory and starting to, you know, kind of get in that reorder mode. You know, the things that CSL Vifor is doing is really starting to pay dividends as they're building this market. Okay, got it. If, I'm not sure if you'd give us this level of details, but when a clinic starts using, they get, you know, Fresenius starts getting someone on board, and they start using it. Are you noticing any pattern once they start? Are they pretty sticky and those are the ones that start reordering it, or is it still a little bit touch and go there? Well, we see across the board, Annabel, that there's really strong buy-in once these clinics start using the product. I say that, you know, there's two metrics I look at. Anecdotally, we hear from the sales force, and we hear actually from provider testimonials as well as patient testimonials that the product's really performing nicely. The key metric that we look at is around reorders. The majority of clinics that start, you know, reorder the product on a continual basis. It becomes a growth annuity, if you will. That's really what we're seeing in the data, and that's why we're encouraged. Okay, great. Yeah, that's actually helpful. I'm going to throw a question out there to Jo, just if you don't want to lead about the development program. On oral difelikefalin, NP or neuropathic pruritus has not been an indication with a tremendous amount of development. What are your expectations for how rapid enrollment could be here, essentially as the first treatment with no real competing programs? Thanks, Annabel. I think we're very confident about the program. Certainly the New England Journal was very helpful for us. You know, as we're in the operational phase and as having looking at stats to come on is many sites are very interested in participating. Which, you know, compared to our phase two study where it was really starting to kick this program off, it was not as well sort of received as it is now. I think that's very helpful for sure. As we've said before, you know, dermatologists are the physicians who see these patients. We remain encouraged and very confident about the timelines that we have put out for enrolling these patients. Okay. Are these patients pretty concentrated among certain physicians or kind of scattered? Not that we've seen to date. Of course, this is a program that will, you know, be a little bit bigger than our phase II study. We are, you know, having more sites on board and just to try and meet those timelines as well. You know, we're not concentrating in any particular area but going quite broad. Okay, great. Thank you so much. Thank you. Our next question comes from the line of David Amsellem, Piper Sandler. Your question, please, David. Thanks. Wanted to drill down on some more on your comments on DaVita. I think, Chris, in the past, you've said that DaVita tends to have a slower process in terms of activating accounts. I'm just wondering if you could comment qualitatively on, you know, what you're seeing out of DaVita. Are you surprised that the number of clinics that have ordered is at 11%? You know, what is your partner doing to try to jump-start that? That's number one. Secondly, can you just comment, if you can, on pricing across Europe and the rest of the world and relative to what we have in the United States? Thank you. Yeah. Hey, David. Let me tackle the last one. That's a briefer conversation. In Europe, you know, we have a public price in Germany that I may have mentioned in the Q4 print. Hopefully I did. And that price is EUR 50 per vial. You know, by and large, it's about a third of the price of the vial in the U.S., which is a $150 list price. It gives you a sense, and that's what I could speak to publicly around Germany. You know, each country obviously will work with the, you know, their national bodies to secure a price and reimbursement as they come online. Your first question around DaVita. Yeah, I have alluded to it before. I mean, you know, they have a different way they adopt new products. They tend to take a more phased approach where they try to gain real-world experience in a more concentrated area of the country, and then they roll it out nationally. It's available nationally now, and you are starting to see, you know, a pickup in the number of clinics dosing of patients. You know, I would say this, David, DaVita is a priority for us and our commercial partner. You know, from my experience, it's really not that unusual for two different customers to do things a little differently. And certainly DaVita and Fresenius are doing things a little differently. You know, DaVita doesn't have the luxury of an internal sales force. One thing that we see with DaVita that's different than Fresenius is the ability to access the clinics. That is a critical factor in driving utilization and educating renal nurses, educating, you know, the lab techs, educating dietitians and social workers are a critical piece of the puzzle. At DaVita, you mentioned, you know, what's our partner doing? Well, they're doing a series of things. They have to be a bit more creative, and there's some lasting effects from the pandemic, you know, given these access restrictions. We've learned a lot around engaging via digital means, engaging at conferences, and that's exactly what CSL Vifor is doing. I think the significant point here is that, yeah, they're a little behind Fresenius, clearly. We are seeing, you know, month to month pickups in the number of new clinics ordering. I always come back to this, David, that one of the most important things that is really encouraging to us and our partner is that once a clinic starts to utilize the product, you know, given the patient testimonials and provider testimonials, that really generates significant reorders. Over 70% of the DaVita clinics that are ordering continue to reorder. It's a really nice growth annuity. Okay. That's helpful. Thank you. You got it. Thank you. Our next question comes from the line of Jason Gerberry of Bank of America Securities. Your question, please, Jason. Hi, this is Chi in for Jason. Thanks for taking our questions. I guess first one on IV KORSUVA. Mm-hmm. you've gave some metrics, 64% of the order came from Fresenius, the rest DaVita and other clinics. Obviously, trying to compare to the past two quarters, you might have given some metrics around it. Mm-hmm. Pardon me if I missed that earlier. You know, regarding, you know, how we should think about the timing on when sales will converge with underlying demand. I think you talked about that inventory is expected to be drawn down by mid-year, what's your latest thoughts on when sales will converge with the underlying demand? Maybe like, second one on oral KORSUVA. Can you walk us through the scenario with the internal readout? What are the outcome for that internal readout that we can expect with the AD trial in fourth quarter? Thanks. Sure, Chi. Let me unpack that. Let me first speak to the evolution of demand orders. That was the first part of your question. Yes, we did mention this quarter, 46,000 vials were ordered from the dialysis clinics, roughly 65% or 64% were driven by Fresenius, ordered by Fresenius. You asked how that compares over the last two quarters. You know, given kind of what Fresenius did in Q3, Chi, as you're aware, you know, they, you know, did a significant stocking order. You know, the primary driver of the Q3, I think there was 184,000 vials. That was pretty much all Fresenius. About 180,000 of that was to Fresenius. Then in Q4, they're obviously, you know, starting to utilize that product. Of the 21,000 vials used in Q4, I would say, you know, probably about 40%, 45% was Fresenius, and the rest was, you know, split between DaVita and the midsize and independent DOs. Our expectation moving forward is it would be probably more akin to what we're seeing in fourth quarter, you know, where Fresenius will be the key driver, at least in 2023, in terms of vials order or demand. Your second question around the normalization of demand and sales. Yeah, we mentioned that by mid-year, we would expect the majority of FMC clinics to have, you know, kinda drawn down, utilize their inventory and what I say be in reorder mode. I would say probably as we get into the second half of the year, you'll start to see sales and demand sort of converge. Then the last part of your question, let me give that to Jo around the oral. Yeah. Hi, Chi. Thanks for the question. As a reminder, Part A is what we are currently enrolling, and we have 280 patients that we will be enrolling in this Part A. Just as a reminder, this is an appropriate number of patients that will give us the information to continue into Part B or KIND 2. What we'll be specifically looking at is looking at the dose as well as the sample size, and we will look at all the data that we will get, so specifically looking at efficacy and safety to be able to select. The most favorable dose that demonstrates the best benefit risk profile, we will be able to assess the sample size. That's what we will be specifically focusing on and sharing, for Part A. If I can clarify, is there a go or no-go decision baked in there, or is this just basically determining the dose selection that sample size heading into Part B? We are looking, yes, exactly for the dose and the sample size, but we will be reviewing the data and assessing what the outcome of the data demonstrates and assessing whether to move forward or not, of course. Okay, great. Thank you. Thanks, Chi. Thank you. Again, to ask a question, please press star one one on your telephone. Again, that's star one one on your telephone to ask a question. Our next question comes from the line of Sumant Kulkarni of Canaccord Genuity. Your question, please, Sumant. Good afternoon. Thanks for taking my question, and I'll draw the details of some of the current market dynamics. Do you expect your partner to hit steady-state operating margins on this product before TDAPA ends? How important would that be for that to happen so you could start realizing substantial collaboration revenues? Sumant, maybe you could clarify. You're asking me, it was a little muffled, my friend, so, you're asking me to comment on the operating margins of CSL Vifor for this product? Not specifically, any quantitative, but how important would it be for the product to hit a steady-state operating margin before TDAPA ends, I guess, is the question? Ryan, do you want to? Maybe are you focused on utilization? Utilization is. Not really. I mean, like, for example, you know, if the product is in launch mode for a longer time than otherwise thought, wouldn't that impact the rate of collaboration revenue that you recognize and that flows down to your bottom line? Oh. That's why I was asking. I got it, yeah. He's asking about the profit split. Ryan, maybe you could- Oh, I see. It's agnostic to that. I think the guidance that I've given on how the profit split works, which is we get roughly 46% of every dollar and the mix between Fresenius and DaVita, more Fresenius, more DaVita fluctuates that percentage by maybe one or two points. It's really not material. It's going to be pretty steady from that point of view. Yeah. Sumant, I just comment, like, on the marketing expense line, on their controllable expenses from a CSL Vifor, that doesn't necessarily impact that profit split. Yeah. It's pretty fixed, Sumant. Right. Right. No, I was talking about absolute dollars more than the profit split. Thanks. Thank you. At this time, I'd like to turn the call back to Christopher Posner for closing remarks. Sir? Thanks. Thanks, Lateef. I just want to take a minute just to wrap things up. You know, I said in my comments, you know, if you look at the key performance indicators of the business, you know, specifically with KORSUVA injection, we're encouraged. I mean, CSL Vifor continues to make progress building this market. It's really reflected in the key trends this quarter. You know, clinic orders doubled. 60% of the FMC clinics are dosing a patient, and each segment is really seeing increases in clinic orders. It's, it is encouraging. We're getting very positive feedback from both patient and physicians on the product, and that's really translating into very strong reorder rates. You know, again, very positive in terms of where we are. We continue to make really good progress. Jo mentioned a little of that, in our pipeline, to our stated commitments. Net-net, you know, we look really forward to continuing to update you on the progress of the KORSUVA launch and our pipeline as we progress. With that, I'll end the call. This concludes today's conference call. Thank you for participating. You may now disconnect.