Good afternoon. My name is Denise, and I will be your conference facilitator. I would like to welcome everyone on the Cara Therapeutics second 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, please press star and the number one on your telephone keypad. Please be advised this call is being recorded. At this time, I'd like to introduce Iris Francesconi, Chief Strategy Officer and Head of Investor Relations from Cara Therapeutics. Ms. Francesconi, you may begin your call. Thank you, Denise, and good afternoon. Just after market close today, we issued a press release detailing our corporate progress and financial results for the second quarter 2022. 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, Rick Makara, Cara's Interim Chief Financial Officer, and Dr. 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 in fact 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 and Kapruvia, risks that KORSUVA Injection and Kapruvia revenue, expenses, and costs may not be as expected. Planned future regulatory meetings and/or submissions and potential future regulatory approvals. The performance of the company's commercial partners, including Vifor. 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, including NP, and the potential for oral difelikefalin to address additional pruritic indications. The size and growth of the potential markets for pruritus. The company's expected cash reach and the potential impact of COVID-19, geopolitical tensions and macroeconomic conditions on the company's 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 Annual Report on Form 10-K for the year ending December 31st, 2021, and its other documents subsequently filed with or furnished to the Securities and Exchange Commission, including its Form 10-Q for the quarter ended June 30, 2022. 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 reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. With this, I will now turn it over to Chris. Thanks, Iris, and good afternoon, everyone. The second quarter was truly foundational for Cara, building the base for our continued growth this year and in the years ahead. We made big strides towards our goal of creating a differentiated company and becoming the world leader in pruritus. Our focus is on treating this distressing, underserved condition that affects millions of patients across many diseases. The second quarter showed us we are on the right path with concrete validation of our strategy. Along with our partner, Vifor Pharma, we made significant progress in the launch of KORSUVA injection. For the second quarter, we recorded in total revenues of $23 million. This consisted of $8 million in profit-sharing revenue from KORSUVA Injection and $15 million in a milestone payment from the EU approval of Kapruvia in April. In addition, our strong phase II proof-of-concept data in notalgia paresthetica highlighted the broad potential of our oral difelikefalin platform. I will give more details on our progress this quarter, and Rick will follow with a review of our 2Q financial results. After that, we will take your questions. In the first quarter on the market, KORSUVA's adoption dynamics are in line with our expectations and in line with the only recent branded product launch in the setting. Specifically, independent and mid-sized dialysis organizations have been the first to adopt and administer KORSUVA Injection. The more rapid product adoption by these organizations is predominantly due to, A, shorter contract negotiations, B, simpler technical implementation of product information, pricing, and reimbursement in respective EMR systems, and C, faster establishment of treatment protocols. We have heard positive anecdotal feedback from the field on the performance of the product. Week to week, we have seen an increase in the total number of clinics ordering, and we have seen repeat orders across the majority of clinics. Turning to the large dialysis organizations, which make up 75% of the market. They are more complex and therefore take somewhat longer with regard to all these steps. However, we are pleased to report that those key elements are in place at the LDOs, and they have started to order KORSUVA early in the third quarter. These early launch dynamics, which are typical of the dialysis market, support our reported product launch metrics. Vifor's net sales of KORSUVA Injection was $17 million. This comprises mostly the initial stocking at the wholesaler based on the anticipated demand from LDOs coming online. We expect that a significant portion of this inventory will get sold into dialysis clinics in the third quarter. The wholesaler shipment to dialysis clinics was about 2,000 vials, reflecting the early but rapid adoption in the independent and mid-size organizations. We have seen demand from this market segment also accelerating. As we head into the third quarter, more firepower has been added to develop the market and help drive product adoption. Specifically, we are pleased with the addition of the Fresenius Renal Pharma sales force to the promotion of KORSUVA Injection. The Fresenius sales force will focus exclusively on Fresenius dialysis clinics and affiliated healthcare providers. This will significantly increase our share of voice in Fresenius clinics, and we expect Fresenius to be a major driver of product sales in the coming quarters. It is also important to note that Vifor's promotional plan has not changed, and its sales force will continue to promote KORSUVA to healthcare providers associated with both Fresenius and non-Fresenius clinics. Lastly, we are pleased with the recent CMS rule proposal that includes a request for information regarding an appropriate payment mechanism for drugs with TDAPA designation post the TDAPA period. We generally believe that the different payment mechanisms outlined in CMS's proposal would provide adequate reimbursement for KORSUVA post the expiration of its TDAPA period. We further support the concept of linking drug payment to drug utilization in appropriate patients. While we do not expect a final decision by CMS regarding the post-TDAPA reimbursement mechanism this year, we are confident that CMS is focused on ensuring long-term access to innovative drugs like KORSUVA. Our pipeline is another potential exciting driver of long-term growth. We continue to validate oral difelikefalin's potential across many indications and diseases. The recent positive top-line results in our KOMFORT Phase II proof-of-concept trial for oral difelikefalin in notalgia paresthetica shows the potential broad applicability of DFK in chronic pruritus. NP is a nerve disorder characterized by chronic pruritus of the upper to middle back and treated by medical dermatologists. Like all our other programs, there are no approved treatment options for NP, and currently used treatments have limited efficacy or safety concerns. The KOMFORT study met its primary endpoint of change from baseline in daily WI-NRS score at week eight, showing a highly statistically significant difference from placebo. Oral difelikefalin had a rapid onset of efficacy as early as week one, which was sustained throughout the entire study period. DFK also reached statistical significance on the additional endpoint of proportion of patients with a four-point improvement in the WI-NRS score starting at week two and through week eight. DFK was well-tolerated with a safety profile consistent with prior studies in other indications. We plan to share the detailed clinical data from this study at an upcoming medical meeting. We also expect to meet with the FDA in the second half of 2022 to discuss the next steps in the development for notalgia paresthetica. We will provide more details for this exciting program at a later time. In our other pipeline programs, we continue to expect releasing top-line results for our phase II proof-of-concept study in primary biliary cholangitis in the second half of 2022. Our phase III programs in atopic dermatitis and non-dialysis dependent chronic kidney disease, which we initiated in the first quarter of 2022, continue to track to our previously announced timelines. In summary, the second quarter has set the foundation for both our near and long-term growth, and we are executing on our three strategic priorities. The first priority is to maximize the commercial potential of KORSUVA Injection with our partner, Vifor Pharma. One quarter into the launch, we are tracking to our expectations. Demand was initially driven by independent and mid-sized dialysis organizations. LDOs have started to order, and the key demand levers are in place, including more sales force firepower. We like the cadence of how these are coming together to drive an acceleration of demand in the coming months. We continue to execute on our second strategic priority of advancing our phase III programs for oral difelikefalin in advanced chronic kidney disease and atopic dermatitis. We made significant progress on our third priority to expand the clinical utility of oral difelikefalin across the spectrum of disease categories associated with pruritus. The positive phase II NP data validate the broad applicability of the oral difelikefalin platform. We are excited and confident for what is ahead. The progress across our strategy in the second quarter is a foundational step toward delivering long-term sustainable growth and value for our shareholders. Now I'd like to hand it over to Rick for details on our second quarter results. Over to you, Rick. Thanks, Chris. As a reminder, the full financial results for the second quarter of 2022 can be found in our press release issued today after the market closed. Cash, cash equivalents, and marketable securities at June 30, 2022 totaled $204.7 million compared to $236.8 million at December 31st, 2021. The decrease in the balance primarily resulted from $30 million of cash used in operating activities. The second quarter of 2022 net loss was $4.2 million, or $0.08 per basic and diluted share, compared to a net loss of $30.7 million or $0.61 per basic and diluted share for the same period in 2021. Total revenue was $23 million for the three months ended June 30, 2022. There was no revenue during the same period of 2021. Revenue consisted of $15 million of license and milestone fee revenue related to the milestone payment earned for the approval of Kapruvia by the European Commission in April 2022 and $8 million of collaborative revenue related to the profit sharing revenue from Vifor's sales of KORSUVA injection to third parties. There was no cost of goods sold during the three months ended June 30, 2022 or 2021, as there was no commercial supply revenue for either period. R&D expenses were $19.9 million for the three months ended June 30, 2022, compared to $25.2 million in the same period of 2021. The lower R&D expenses were principally due to a $10 million milestone earned by Enteris during the three months ended June 30, 2021, partially offset by increases in direct clinical trial costs and related consulting costs during the three months ended June 30, 2022. G&A expenses were $7.6 million for the three months ended June 30, 2022, compared to $5.7 million in the same period of 2021. The higher G&A expenses were principally due to increases in stock-based compensation expense, which included additional compensation expense relating to the modification of the company's former Chief Executive Officer's equity awards in November 2021, as well as increases in accounting and auditing fees and payroll-related costs. Other income was $0.3 million for the three months ended June 30, 2022, compared to $0.1 million in the same period of 2021. The increase was primarily due to an increase in interest income resulting from a higher yield on the company's portfolio of investments during the three months ended June 30, 2022, partially offset by an increase in net amortization expense of available-for-sale securities during the three months ended June 30, 2022. Now looking forward to financial guidance. Based on timing expectations and projected costs for current clinical development plans, which include conducting supportive phase I trials, phase II trials in PBC and NP, and phase III trials in CKD and AD, Cara expects that its current unrestricted cash and cash equivalents and available for sale marketable securities will be sufficient to fund its currently anticipated operating expenses and capital requirements into the first half of 2024 without giving effect to product revenue we receive from the commercialization of KORSUVA Injection or Kapruvia or any potential milestone payments or potential additional product revenue we may receive under collaboration agreements. Now I'll turn it back over to Chris. Thanks, Rick. With that, Rick, Jo and I will be happy to take your questions. Denise, we can now open the call up for questions. Great. At this time, we will conduct a question-and-answer session. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. Just a few moments while we compile the Q&A roster. Our first question comes from the line of Daniel Wolle with JP Morgan. Your line is now open. Hi, everyone. Congrats on the quarter, and thank you for taking our question. Three questions. First one, can you help us understand the wholesaler number of 1,812 vials and how that translates to $16 million in net KORSUVA sales? Second, can you provide us with some color on the cadence of coding establishment or reimbursement establishment at different dialysis centers during the quarter, and how that might evolve in the following quarters? Last but not least is related to that, can you qualify for us your remarks regarding the net sales that are mostly due to wholesaler versus end user demand? Thank you. Yeah. Daniel, great hearing from you. Let me take those one at a time. The first is around the net sales number. It's about revenue recognition, essentially. It's a timing thing. We book revenue when Vifor ships product to the wholesaler. That's when we recognize revenue. The 1,812 vials are what the clinics order from the wholesaler. There's two different things in the revenue recognition. That's an important part. The second question you had was around coding, and essentially what we're asking is, are the dialysis organizations ready to provide access to this product? Are they set up? The short answer is yes. On the LDO front, they are ready, the systems are updated, and in fact, as I mentioned, we are actually seeing orders, beginning in the third quarter. We're actually quite optimistic about what we should expect in the months to come. Right. Last but not least, if you can quantify for the remark that there mostly what you saw was, wholesalers talking versus end user demand. Yeah. Again, the way we book revenue, Daniel, is we recognize that when Vifor ships vials to the wholesaler, that's the $16.8 million in net sales. What we're also then providing, if you remember, I committed to providing the number of units that the dialysis clinics have actually ordered from the wholesalers, as we believe that's a good proxy for end user demand. That's the 1,812 vials. Two different things. It's not as simple as just multiplying the WAC price times the number of vials. Two different things. Okay. Got it. Thank you. You got it. Thank you. One moment please for our next question. Our next question comes from Chris Howerton with Jefferies. Your line is now open. Great. Thank you so much for taking the questions. I think I have two. One kind of related to the line of questioning that Daniel had about the wholesaler and the stocking. I guess, you know, can you give us a little more color, I guess, on kind of the expectations we could have on the organic demand from the larger institutions? And I guess if you could comment at all about, you know, Fresenius versus DaVita. You know, my assumption would be, and I, that Fresenius would be easier to execute on that side given the relationship with Vifor. And then the second question that I have is related to the NP indication. You know, just what types of features would you seek to gain alignment with on the FDA regarding presumably the phase III design? Then a sequel to that, you know, in the past there was discussions about getting a very broad label for oral KORSUVA for just a broad antipruritic. I'm curious if you're still on track for that in relation to the different domains of indications. Thank you. Great, Chris. I'll tackle the first one. I'll turn it to Jo to tackle NP. I'll be crystal clear, or I'll try to be crystal clear in terms of channel stocking and demand. I'm gonna take both of those separately. Channel stocking or channel strategy, it's an important part, as you probably know, of any launch strategy. Levels are defined in accordance with future demand as projected by Vifor. Vifor put product into the channel anticipating future demand. That's the channel strategy, and I'm quite pleased with how that progressed, and that's how we booked the $16.8 million in total sales, and obviously Cara's profit is $8 million. But the key is demand. Essentially what I'm saying is the future demand is gonna be really dependent on the LDOs coming online, and that's exactly what we're seeing. They came online, you know, just more recently, and we're seeing ordering already. It's on formulary. We're seeing ordering. I can't comment specifically on the different customers. You mentioned Fresenius and DaVita. Can't comment specifically on those two customers, but I will say that, you know, we are quite pleased. I was quite thrilled with the addition of the Fresenius sales force to the mix. That's additive and complementary to Vifor. We would fully expect the LDOs, you know, gradually adopting this product and really contributing to the majority of growth moving forward. You know, Chris, it's a very similar pattern we actually saw with Parsabiv, where the MDOs, the midsize and the IDOs with the initial uptake, with more gradual uptake in the LDOs and them becoming the majority of the growth. I would expect that same sort of sequence, and that's exactly what we're seeing. On the NP, Jo, if you wanna tackle that one. Yeah. Thanks, Chris. With the FDA, we plan to have further discussions about our clinical development program, before the end of the year, this year, and it would really be focused on what the clinical development program would look like. We know we need to do some dose finding. The discussion will be what that program would look like. Of course, Cara will try to see if we can accelerate, you know, the program, to include that, dose finding as well as validated studies. We expect that to revolve around typical questions that need to be asked of the FDA, for developing a clinical program. As far as the broad label goes for difelikefalin as a broad label, we'll first tackle the NP part and then take it from there and give further updates after that meeting. Okay, that's great. That's excellent. Thank you so much for taking the questions, and congratulations again. Thanks, Chris. Thank you. One moment for our next question. Our next question comes from Joseph Stringer with Needham & Company. Your line is now open. Hi. Thanks for taking our questions. Congrats on the quarter. Can you comment on the initial margins from Vifor here coming from net sales, down to, you know, before the profit/loss share is applied, just in terms of what the sort of percentage there, and is that in line with sort of what you would expect going forward in subsequent quarters? On the Kapruvia launch, can you kinda walk us through the cadence of when you would expect sales contribution from that as you know country-specific reimbursements come online? Thanks for taking our questions. Yeah, Joe, absolutely. Let me give the financial profit sharing to Rick, and then I'll tackle the Kapruvia one. Rick? Yeah, thanks for the question, Joe. You know, we don't provide specific guidance on the profit share calculation. But what I can tell you is that based on the net sales for the quarter, the profit share was in line with our expectations. We were not surprised by it, if that helps. Yeah. Joe, on Kapruvia, you know, obviously we're quite excited we got approval in April this year. You know, we're on track to launch in several countries in the second half of this year, obviously with our partner Vifor. I would anticipate seeing some launch countries come online. In terms of, you know, kind of the market development, I would say, you know, Vifor has done a very nice job in terms of developing the market, as they did in the U.S., and they're doing a similar cadence of market development activities outside the U.S. As countries come online, that's really gonna be dependent on reimbursement, and their negotiations with the national payers. I would expect, again, a few countries to come online in the second half of this year. Great. Thank you so much for taking our questions. Thanks, Joe. Great. Thank you. Stand by for the next question, please. Our next question comes from David Amsellem with Piper Sandler. Your line is now open. Hey, thanks. I had a near-term focused question and that's about the quarterly sales and profit sharing cadence. You mentioned, Chris, the wholesaler stocking. I apologize if I missed this, but does it stand to reason then that, you know, perhaps the recorded sales and profit share in 3Q might be somewhat softer or because you're getting buy-in from the large dialysis organizations that you're gonna see Vifor continue to sell into the channel. Just help us understand how we should think of that cadence in 3Q and I guess fourth quarter as well. Yeah. I have a follow-up. Thanks. No, no, certainly, David. Let me tackle that one. You know, with any launch, I mean, especially the way we record, we record revenue when obviously Vifor ships to wholesalers and then there's the demand generation. It's really a matter of timing. Here's what we would expect. We would expect, obviously, demand to accelerate given that Fresenius and DaVita, the LDOs, are really online now. We're on formulary protocols in place, systems updated, and we're already starting to see some ordering at those clinics. You know, this is a marketplace dominated by really two customers. They account for 75%-80% of all the dialysis patients. Demand will accelerate. I would fully expect the launch inventory, as mentioned on the call, to get drawn down accordingly in the third quarter and into the fourth. To me, it's really about demand. That's where, you know, I'm encouraged and I'm excited when you layer on the Fresenius sales force coupled with, you know, obviously getting on the formulary and getting protocols in place and the staffing trained. You know, I'm very optimistic that we're gonna experience a good acceleration. As with most launches, you know, the balance between the trade inventory and the end user demand, you know, that'll reach some sort of steady state in the next few quarters. Okay, that's helpful. The follow-up is regarding, you know, inventory. Can you just talk about what we should think about in terms of steady state, how many weeks in the channel, you know, is steady state? Is it fair to assume that, you know, inventory levels are, you know, customarily gonna be tightly managed here? Yeah, I would take the latter part of your question, and when I say steady state inventories, you know, I would say it's more customary. You know, clearly Vifor put product into the channel with the anticipation, rightfully so, of demand. That's the channel strategy at launch. That's exactly what we saw, and that's exactly what they executed. I would exactly, as you said, I would see steady state with inventory at, you know, very tight and where sales, net sales is probably more congruent to end user demand during steady state. Got it. Okay, that's helpful. Thank you. Thanks, David. Thank you. Please stand by for the next question. Our next question comes from Oren Livnat with H.C. Wainwright. Your line is now open. Thank you so much. I have a couple. If I could, follow up on the earlier question about margins, and obviously you can't give guidance for Vifor, but, you know, we can all do math here, and I think you reported collaboration revenue of, you know, 47% of net sales, which, you know, assuming it's a 60% profit split at non-Fresenius accounts, I can back into a nearly 80% operating margin for the, you know, sales to date. I just wanna make sure before we get silly and carry numbers like that forward, should we assume that there maybe are some, you know, material costs that were not grossed against those numbers this time around, considering it was just channel fill, you know, from a, I guess, a Vifor accounting perspective? Can we just go ahead and say, wow, you know, this is as this drug grows, it's only gonna be at least this profitable, going forward as we start thinking about, you know, as we model of revenue, how much we should- Mm-hmm, mm-hmm. estimate it flows to you. I have a follow-up. Thanks. You got it, Oren. Let me give Rick the first question. Yeah. On the profit share, yeah, I mean, you did the math right. Like I said when I got the initial question, based on net sales of just under $17 million, a profit share of $8 million was within what we expected. That wasn't a surprise for this quarter and going forward, you know, it shouldn't be that much different. Yeah, Oren, I would ask you. I guess that's why somebody bought Vifor. Yeah. Go ahead. What's that? What's What's that, Oren? Go ahead. I said I guess that's why somebody acquired Vifor, 'cause that's a lot of profit. Yeah, it's in the home stretch, as they say, Oren, to kinda what we saw. Yeah. this quarter. All right. You can if you had something else to follow up on that, and I have another question unrelated. No, go ahead. Go ahead, Oren. Okay. Okay, great. Go where you were. Sorry about that. Just regarding the timing of the large dialysis centers coming on board. Mm-hmm. I mean, I had assumed sort of right out of the gates that, you know, Fresenius, I guess, would be the most likely earliest indicator, or earliest adopter, just given, you know, the setup. It sounds like they are just coming online into the third quarter. I'm wondering if there was any hangup there, because I thought in early May you talked about having all the sort of reimbursement and pricing data sort of online or in systems, which I assume to mean at Fresenius and DaVita as well. What would be the reason why it would take months to sort of start seeing the first orders coming in from the LDOs? Yeah. So Oren, I would say this, I mean, Vifor has done a really nice job working across the board with, you know, the LDOs, the MDOs, and the IDOs. I mean, they. This is not sequential, right? They do this all at the same time. MDOs and IDOs, you know, we fully expected to come online earlier, just smaller organizations. You know, a typical MDO may have 200 clinics. What has to transpire is obviously, and you probably know this, now to get on formulary, you get protocols in place, get on formulary, get contracts in place, and then ensure the systems are updated and the staff is trained, 'cause we're changing the way dialysis is done. That's a much quicker process in the MDO and IDOs. On the LDOs, you know, yeah, I mean, it took. They're more complex, quite frankly. They took a little longer, as we expected, versus the MDOs and the LDOs and IDOs. I wouldn't say there's any hang-ups, it's just part of the process, and you're taking like a Fresenius that may have 2,800 clinics, and you're not only getting protocols and contracts in place, you're making sure all the staff is trained and the systems are updated, so they can order. You know, that's what I mentioned in my prepared remarks. I'm actually quite pleased, that you know, that they were able to implement. Mm-hmm. These contracts that quick. You know, given now that the sales force of Fresenius is also on board, I mean, it provides me and our team here as well as Vifor obviously with a lot of optimism now since the LDOs are the market essentially. All right. Thanks for the clarity. Appreciate it. You got it, Oren. Great. Thank you very much. One moment for our next question. Our next question comes from Jason Gerberry with Bank of America. Your line is now open. Hey, guys. Thanks for taking my questions. I was wondering if you could talk a little bit about the two large DOs and just the sort of treatment protocol decision-making. Is this sort of a singular top-down decision that permeates all the clinics within the LDO or is the decision-making more fragmented? Just sort of wondering if you can kind of shed a little more light on that dynamic. You know, thinking about just the commentary about 3Q with the ordering patterns, I mean, are we talking about sort of small, medium, large in terms of just the indication of demand that you're seeing for 3Q? Thanks. Hey, Jason. Yeah, certainly. The protocols, especially at the LDOs, are centralized, and then they're pushed down to the individual clinics. You know, in terms of the protocols, I can't speak specifically to protocols on Fresenius, DaVita or any of the MDOs, but what I can tell you is that they're not rate limiters. If a physician identifies an appropriate patient, they get the product. That's the good thing. I think the other thing I would comment on is why we're so encouraged is that, you know, the systems, getting the systems and getting folks trained up across all these clinics is a process, and we're actually seeing that come to fruition and actually with some speed. We're quite thrilled about what we're seeing in terms of the dynamics and demand generation. When it comes to Q3, as I mentioned before, I mean, given the channel strategy, and the launch inventory, we would fully expect that to burn down in Q3, in congruence with the acceleration of demand. How that looks in Q4, you know, we'll have to see how demand transpires. But as you know, right now, you know, between us and Vifor, we're not giving any forward-looking guidance around sales and demand. Yeah. Okay. Thanks. You got it, Jason. Great. That was the end. I have no more questions at this point. I would like to turn it back to Cara Management for closing remarks. Well, thank you, Denise. Really thanks everyone for joining us today, and I'm wishing everybody a great week ahead. Thank you for your participation in today's conference. This concludes the program. You may now disconnect.