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spk07: Good afternoon, and welcome to CARA Therapeutics' third quarter 2021 financial results conference call. All participants are now in the listen-only mode. There will be a question-and-answer session at the end. Please be advised that this call is being recorded at CARA's request. I would now like to turn the call over to the CARA team. Please proceed.
spk10: Good afternoon. This is Will Gramig with Stern Investor Relations. and welcome to Kara Therapeutics' third quarter 2021 financial results and update conference call. The news release became available just after 4 p.m. today and can be found on our website at www.karatherapeutics.com. You may also listen to a live webcast and replay of today's call on the investor section of the website. 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 commercialize Corsuva injection, including the timing of additional regulatory submissions and approvals, the company's ability to maintain coverage and adequate reimbursement for Corsuva injection, the performance of our commercial partners, including V4 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 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 Kara 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 reflect events that occur or circumstances that exist after the date on which they were made. Participating on today's call are Dr. Derek Chalmers, CARA's President and Chief Executive Officer, Mr. Christopher Posner, CARA's incoming President and Chief Executive Officer, and Mr. Thomas Riley, CARA's Chief Financial Officer. I'll now turn the call over to Dr. Chalmers.
spk01: Great, thank you, Will, and good afternoon, everybody, and thanks for joining us today. CARA has had a truly transformative third quarter this year, highlighted by the FDA approval on August 23rd of Kursuva injection for the treatment of moderate to severe pruritus associated with chronic kidney disease in hemodialysis patients. As the first and only treatment approved by the FDA for chronic kidney disease-associated pruritus, Trusova injection represents a true paradigm shift in the treatment of pruritus. This approval is also a testament to the long-term diligence and the collective effort of the entire CARA team to bring this drug over the finish line. With the FDA approval in hand, we continue to be focused, along with our U.S. commercial partner, V4 Pharma, on preparation for the launch of Kursuva injection in the first half of 2022. We are also continuing to make important progress in our oral Kursuva programs, and following guidance from the FDA, aim to initiate Phase III programs with oral Kursuva for the treatment of pruritus in both atopic dermatitis and non-dialysis-dependent chronic kidney disease patients in the first quarter of 2022. So, as we reach this transformative stage in CARA's development with the anticipated U.S. commercial launch for Kursuva injection, with great momentum in our oral Kursuva franchise as we plan to move into registration programs, and with a strong balance sheet in place allowing us to execute on all our strategic goals, I believe that the present moment marks a natural point to transition leadership. As we announced last week, I'll be stepping down from my current role as President and Chief Executive Officer of Cara and transitioning to a senior advisor role with the company, and Chris Posner will move into the President and CEO position. Now, having worked closely with Chris since he joined Cara as a board member, I'm confident in his ability to successfully lead the company through its next phase of development, and I look forward to working with him and the Cara leadership to ensure a smooth transition. Now, I'd like to invite Chris to say a few words and introduce himself. Chris, please.
spk06: Yeah, thanks, Derek. I am really thrilled to be joining such an inspiring team as Chief Executive Officer to lead CARA into its next phase as a commercial stage biopharmaceutical company. I originally joined CARA in 2018, as Derek said, as a board member, as a director. And over the past years, I've worked closely with the entire team, CARA team, in this capacity. I believe in CARA's mission to maximize the potential of our novel platform therapeutic Corsuva and fundamentally change the way that chronic intractable pruritus is treated to return quality of life to each and every patient living with pruritus. Now, I want to take a quick moment just to express my gratitude to the Board of Directors for placing its trust in me to lead the company. And I really want to thank Derek for his support during this transition period. From co-founding the company through to the FDA approval of Corsuva injection, his contributions to CARA are indelible. And I really look forward to ensuring a smooth leadership transition with his support and building on the immense clinical and corporate progress to date as we really prepare to open a new chapter as a commercial stage organization. I look forward to working with the entire care team and getting to work. So back to you, Derek.
spk01: Great. Thank you, Chris. Now I want to review the recent progress across each of our pipeline programs during the third quarter, and then I'll turn the call over to Tom to detail our financial results. So starting with Krasuva injection, as we prepare for commercial launch, our partner, V4 Pharma, is currently embarked on a Salesforce-driven disease state education program across the U.S. market in anticipation of launch next year. In addition, in September of this year, V4 Pharma and CARA submitted the required documentation for both Tdapa and reimbursement code to the U.S. Centers for Medicare and Medicaid Services to secure timely reimbursement and patient access to Krasuva injection and enable a commercial launch in the first half of next year. As a reminder, CARA executed a strategic license agreement with V4 Pharma in the fourth quarter of 2020 for the expanded commercialization of Krasuva injection in all U.S. dialysis clinics. That agreement features a CARA 60% V4 Pharma 40% profit-sharing arrangement in non-frazenious medical care clinics in the U.S., which is approximately 60% of the total market. And under the terms of the agreement, in October of this year, upon U.S. regulatory approval of Trusova Injection, the company received a $50 million common stock investment at a 20% premium to the 30-day trailing average of CARA's common stock price. In addition, the company is eligible to receive payments of up to $240 million upon the achievement of certain U.S. sales-based milestones. Under our 2018 license agreement, V4 Fresenius Medical Care Renal Pharma and CARA agreed to market Kursuva injection to Fresenius Medical Care North America dialysis clinics in the U.S. We are approximately 40 percent of the U.S. market. Under a CARA 50 percent, V4 Pharma 50 percent profit share arrangement And under this agreement, in October of this year, we received an additional $15 million cash payment earned based on U.S. regulatory approval of Prusiva injection. Turning now to ex-U.S. commercialization planning, we were very pleased to announce earlier this year that the EMA accepted the MAA for diphalocephaline injection for the treatment of pruritus associated with chronic kidney disease in hemodialysis patients. And the EMA will review the application under the centralized marketing authorization procedure. Under our 2018 license agreement, V4 Fresenius will be responsible for the commercialization of Kursuva injection across European territories, with CARA eligible to receive tiered double-digit royalty payments based on annual net sales, and up to $440 million in tiered commercial milestones, all of which are sales-related. The EMA is expected to render a decision in the second quarter of 2022. So, turning now to progress in our oral Cursiva pipeline. In Q2 of this year, we announced top-line results from the CAER phase two dose-ranging trial of oral Cruciva for the treatment of moderate to severe paritis in atopic dermatitis patients. And this trial was a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of oral Cruciva in 401 adult subjects with atopic dermatitis. Patients in that trial were stratified across treatment groups by disease severity. with 64 percent of patients characterized by mild to moderate atopic dermatitis, and approximately 36 percent of patients characterized by moderate to severe atopic dermatitis. And patients were randomized to three tablet strengths of oral Krasuva, 0.25 milligrams, 0.5 milligrams, and 1 milligram, taking BID versus placebo for 12 weeks, followed by four weeks of active extension. Now, the CAER results provided key information related to a defined patient group, an active dose range, and very importantly, an effect size on the registration four-point responder endpoint from which to design appropriately powered phase three trials. With this data in hand, we held an end of phase two meeting with the FDA in Q3 of this year, and I'm pleased to announce that based on guidance from that meeting, we aim to initiate a phase 3 program with oral crossover for the treatment of moderate to severe pruritus in AD patients in Q1 of next year. And we'll announce more details around the design and composition of that registration program when we initiate the Phase 3 trials. Moving on to our program in non-dialysis-dependent CKD patients with moderate to severe pruritus. We conducted an end of phase two meeting with the FDA in Q2 of this year with the goal of defining a phase three program in these patients. At that time, the agency indicated the viability of stage five predialysis CKD patients as a population for that program. We subsequently submitted pruritus incidence and epidemiological data to further define a viable patient population for inclusion. And earlier this month, we were pleased to receive FDA-written guidance that the patient population can be expanded to include both Stage 5 and the group of Stage 4 predialysis patients with advanced CKD in a registration program consisting of two pivotal Phase 3 clinical trials. And we expect to initiate this program also in the first quarter of 2022. Finally, to our ongoing Phase II trials in PBC and Natalja Parasetica. Now, I want to remind everyone that due to the ongoing COVID-19 pandemic and in accordance with the FDA's updated guidance for conducting clinical trials, we've implemented numerous clinical and operational measures to prioritize the health and safety of patients, our employees, and study investigators, and to minimize potential disruptions to our ongoing clinical studies. Now, pruritus is a very common symptom of cholestatic liver diseases. Twenty to thirty percent of these patients overall experience pruritus, with that number rising to approximately 70 percent of patients with primary biliary cholangitis. Our 16-week phase two trial is designed to assess the safety and efficacy of a one milligram tablet strength of oral cursiva taken twice daily versus placebo in PBC patients with moderate to severe pruritus. Primary endpoint is the change from baseline in the weekly mean of the daily 24-hour worst-edge NRS score at week 16. We now expect to report top-line data from this study in the first half of 2022 due to delays in site initiations and in inpatient enrollment resulting from the ongoing COVID-19 pandemic. Finally, earlier this year, we initiated a Phase II proof-of-concept trial of oral Crosuva for the treatment of moderate to severe pruritus in patients suffering from entalgia parasitica, a neuropathic disorder characterized by chronic pruritus of the upper to middle back. That Phase II multicenter randomized double-blind placebo-controlled eight-week study is designed to evaluate the efficacy and safety of oral Crosuva for moderate to severe pruritus in approximately 120 subjects with Natalgia parasitica, randomized to receive oral Crossova, two milligrams twice daily, versus placebo for eight weeks, followed by a four-week active extension period. Primary efficacy endpoint is the change from baseline and the weekly mean of the daily 24-hour worst-edge NRS score at week eight of treatment. Now, I'm pleased to note that this trial has now passed the 70 percent enrollment mark, and based on current recruitment rates, we do expect full enrollment of this trial by the end of this year. So, overall, the very significant progress that we've achieved at CARA during the third quarter and in recent months, I believe, lays the foundation for a very successful upcoming year, with U.S. commercialization of Krasuva injection on deck. and advancement of oral Cursiva into registration programs, as well as anticipated Phase II readouts next year, 2022 promises to be a catalyst-rich year in the ongoing development of the company. And with that, I'll turn it over to Tom to detail our third quarter financial results. Tom.
spk02: Thank you, Derek. As a reminder, the full financial results for the third quarter 2021 can be found in our press release issued today after the market closed. Cash, cash equivalents, and marketable securities at September 30, 2021 totaled $193.4 million compared to $251.5 million at December 31, 2020. The decrease in the balance primarily resulted from cash used in operating activities of $58.8 million, partially offset by proceeds of $1.3 million from the exercise of stock options. For the three months ended September 30th, 2021, net loss was $1 million, or two cents per basic and diluted share, compared to a net loss of 16.5, or negative 35 cents per basic and diluted share for the same period in 2020. Total revenue was $20.3 million for the three months ended September 30th, 2021, compared to $9.3 million during the same period of 2020. The company recognized $20 million license and milestone fees for the three months ended September 30th, 2021, related to the regulatory milestones the company earned from V4 and VMCRP as a variable consideration was deemed probable upon the regulatory approval of Cursuva injection in August 2021. Of the $20 million earned, $15 million was from the VF MCRP agreement related to the cash milestone with the regulatory approval, and $5 million represented the 20% premium within the $50 million equity milestone investment under the agreement with V4. The license fees License fees revenue of $9.3 million for the three months ended September 30, 2020, was related to license fees earned by us in connection with the VFM-CRP agreement. Now turning over to our cost for the quarter. Research and development expenses were $15.5 million for the three months ended September 30, 2021, compared to $21.1 million in the same period of 2020. The lower R&D expenses in 2021 were principally due to a net decrease in costs associated with clinical trials and a 2.5 million milestone earned by NTERRS during the third quarter in 2020, partially offset by increases in stock compensation expenses and payroll costs. General administrative expenses were 5.9 for the three months ended September 30, 2021, compared to $5.2 million in the same period of 2020. The higher G&A expenses in 2021 were principally due to an increase in stock compensation expense, consulting costs, legal fees, and insurance costs. Other income net was $0.1 million for the three months ended September 30, 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 the company's higher average balance of its portfolio of investments in the 2021 period. Now turning to our financial guidance. Based on timing, expectation, projected cost for current clinical development plans, CARA expects that its existing unrestricted cash and cash equivalents and available-for-sale marketable securities as of September 30, 2021, including the milestone payments received in October 2021 of $65 million from V4 and VFM CRP, will be sufficient to fund our currently anticipating operating expenses and capital expenditures through 2023 without giving effect to potential product revenue under existing collaborations and any additional milestone, potential milestone payments. With that, I will now turn the call back over to the operator for Q&A.
spk07: Participants, we will now begin the question and answer session. To ask a question over the phone, you may press the star key followed by the number one from your telephone keypads. To withdraw your request, you may press the pound key. Again, that's star one to ask a question or the pound key to withdraw your request. Speakers, our first question is from Jessica Fye of J.P. Morgan. Your line is now open.
spk08: Hey, guys. Good afternoon. Thanks for taking my questions. A couple here. Was it always expected that you would need two pivotal phase three trials in the non-dialysis-dependent CKD population? How long do you think it'll take those trials to enroll?
spk01: Yeah, hi, Jess. Thanks for that. You know, so initially in our initial interaction with the FDA, you know, the guidance from the agency was that if that program was confined to stage five non-dialysis dependent CKD patients, then the similarity there, in their opinion, was so high to hemodialysis patients that it may be possible to conduct that program with one pivotal phase three trial. As you know, we've been interacting with the agency since that end of phase two meeting, discussing our data and epidemiological data that's published as to the similarity of stage four and stage five patients, CKD patients, and our belief that that represents a viable population for the phase three program. So now that we have the ascension from the agency to expand beyond stage five to the portion of stage four patients, they see a more traditional program as being appropriate there with two pivotal phase three trials. So that's what we're planning to conduct and get that program underway next quarter.
spk08: And how long do you think it'll take them to enroll?
spk01: Well, I never like to guide to... to outcomes until we start the trials just so we see how the enrollment is going. So that's what we'll do. Once we get the trials underway and we have at least a quarter under our belt and look at enrollment rates, then we'll guide as to when we see output.
spk08: Okay. And then how many trials will be in the Atopic Derm Phase III program? And lastly, In light of all these pivotal studies starting up, how should we think about the ramp in R&D spending next year?
spk01: Yeah, so the AD program is going to be traditional, again, to standard Phase III pivotal trials. And, of course, we'll be looking for long-term exposure data there as well, 52-week exposure data. So that's going to be a standard registration program. The guidance that you've just heard from Tom, actually incorporates all of these programs within that. So, as you know, we sit today with a very strong balance sheet. We can certainly, you know, move on all of these programs simultaneously and still see runway at this point through 2023, and that's not assuming any upcoming profit share income from the launch of Cursiva Injection or any milestones we'll be seeing from either our U.S., license agreement with V4 or our EU agreement with V4. So we're well-possessioned to run both programs. Thank you. Thanks, Jeff.
spk07: Next question is from Chris Howerton of Jefferies. Your line is now open.
spk04: Great. Thank you very much for taking the questions. Two from me, I think. One would be, Well, maybe three actually. So first of all, with respect to the stage four CKD patients, maybe first can you just help us understand maybe the magnitude of that impact in terms of potential patient population that you could address with the stage four versus stage five? The second question would be, and I think if I'm remembering this right, Derek, and I apologize if I'm not, was that Corsuva, even oral Corsuva, is renally excreted. So if that's true, how should we be thinking about the dosing concentration and frequency for the less renally impaired patients? And then the third, I think, is just a simple housekeeping one. In terms of the process, to getting commercial supply ready and launch for V4 and yourselves for the injectable Corsuva. Could you just remind us of what the timelines are for the Tdapa and the CMS coding, when you should hear back from those? Thank you.
spk01: Yeah. Great, Chris. Thanks. Thanks. You got a three for that. That's good. So in terms of the non-dialysis-dependent CKD patients and the numbers there, so as I said, the agency has now guided that program would be appropriate, including both stage 5 and later stage 4 patients or stage 4 patients with advanced CKD. In the U.S., there's approximately 1.1 million U.S. patients in stage 4 at any time. The vast majority of these will progress to advanced stage four, or indeed stage five, or some go straight into dialysis. In terms of pruritus incidence across that group of patients, it's approximately 30% at the moderate to severe level. And then stage five NDD patients, approximately 100,000 at any point in the U.S. approximately 40% of those are seen moderate to severe pruritus. So when you work through those numbers, Chris, and think about those as you look at your modeling, this is an addressable patient population that's actually slightly bigger than the hemodialysis population when we think of moderate to severe pruritus incidence there. So that's the first thing on the patient population. On your second question on PK-PD, yes, you're entirely correct that diphalekephalin or Krasuva is excreted whole via the kidney predominantly. There's no active metabolites here. And you may or may not recall, we've actually run pretty extensive PK studies in non-dialysis-dependent CKD patients, so we know what exposures we can achieve with appropriate dosing there. And the appropriate dosing based on that PK analysis is QD, so it's a once-a-day dosing in the CKD patients, which contrasts with the AD program, of course, where those patients have normal kidney function, and there we're looking at BID dosing. And then on making sure we're prepared for commercial launch next year, we have filed, as I said in our prepared remarks, we've filed both our HCPCS or JCODE and Tdapa applications actually in September of this year. We've been working very closely with CMS and I think the CARA team has really done a great job and led this for a number of years now. And based on those interactions, we expect to hear back from CMS by year end on those applications and that will allow implementation in the first half of 2022. So that's the timing in relation to commercial launch on those.
spk04: That's great. Derek, maybe just one very minor clarification. For the Stage 4 versus Stage 5, are there any anticipated differences in dosing, concentration, or frequency? No, none. Okay. All right. Well, thank you very much for taking the forfeiter.
spk01: Thank you, Chris.
spk07: Next question is from David Amselm of Piper Sandler. Your line's now open.
spk05: Thanks. So just actually had a couple of questions of Chris, if I may. So just looking ahead longer term at the business, what are your thoughts on the potential build-out of commercial infrastructure, whether it's in the uh, a nephrology office setting or for atopic dermatitis, uh, to support, uh, to support dermatologic, uh, indication. Um, just wanted to get your, your thoughts and are there any different than, um, what, um, what Derek and the team has said, uh, previously, uh, regarding commercial infrastructure. And then, you know, secondly, um, you know, this is, this is a really long-term question. Um, but I feel like asking it anyway. To the extent you do build out commercial infrastructure, you're sort of in the single product company category, if you will. So as you think more expansively about the business, do you think about other assets, or are you just looking at multiple indications and building out different Salesforce verticals? Just in general, it's all under the umbrella of, you know, kind of where you want to take the company. Thanks.
spk06: Yeah, no, and thanks for asking those. I think the first question was around the commercial infrastructure build-out in the near term. And certainly, you know, concur with the team. I've been on the board, so I've been a part of a lot of these discussions. You know, the first thing I would say is, you know, we have a great partner in V4. that they are taking, they're doing the full commercialization with Corsuva injection. So we're pretty excited about that and partnering with them. And, you know, I think that's some of the value I could bring working on the launch with not only our team at CARA, who we've got a great commercial lead, and then also working, obviously, with V4. So we'll be really focused on ensuring a successful launch of the Corsuva injection I think longer term, you know, as we think about commercial infrastructure buildup, that's something that we'll look as we progress the data. You know, obviously I spent a lot of time in dermatology over the last, you know, four and a half plus years. That's an area I know well. We would certainly think about, you know, in years to come, you know, how we'd want to approach that market. I think the longer term question is a really interesting question about, you know, you Obviously, utilizing that commercial infrastructure if and when we do build out to look at other adjacencies, it's always a possibility. But I kind of, you know, listen, end of the day for me, and I know for the care team, I mean, we're laser focused on being the world leader in chronic pruritus. That's why I joined the board three years ago. That's really my motivation and my priorities initially in building out not only the course of injection launch, but also, you know, really building out and accelerating the clinical programs.
spk01: Thank you. Thanks, David.
spk07: Thanks, David. Next question is from Annabel Saming of Stiefel. Your line is now open.
spk09: Hi, guys. Thanks for taking the question. I'm sorry if I missed it, but when you talk about the two CKD trials for phase three, first, are they going to be simultaneous? And does that also include a safety? I missed if you said it was going to require 52 weeks safety. And to what extent can you pull from the IV safety database with the phase stage four patients in there? And then the second question I had was, I guess you've alluded to parsitive as a good launch proxy for another renal drug, and I'm just wondering what gives you that confidence. Have there been any other drug launches in dialysis that's seen that kind of uptake, and why is parsitive the right proxy? Thanks.
spk01: Thanks, Annabelle. Yeah, so on the CKD or the anticipated CKD, oral CKD program, yeah, we will most likely run those phase three trials simultaneously. Obviously, we're looking to advance that program as rapidly as possible, and we'll have extensions on each of those trials that will bring us the required safety numbers, which you're familiar with for a chronic indication. Of course, I think we will be referencing our IV data as part of that safety database, but we won't be relying on that. We'll make sure we get the ICH appropriate numbers from our phase three program as we design that. What was your other question? Parsebib as a model of a proxy. As you know, there are similarities with the Parsip story and our story and their distinct dissimilarities. But as an example of what can be done in this highly concentrated, as you're well aware now, market space where, you know, really two players in Fresenius and DaVita occupy 80% of that market and provide dialysis services to 80% of the patients. And as you know, we already have a a relationship with Fresenius as part of our V4 Fresenius license agreement, which I think will add significantly to the momentum as we launch this drug. Parsabiv, in terms of similarity, is a drug addressing parathyroid hormone dysfunction that does occur in approximately 40% of dialysis patients, and of course we are addressing moderate to severe paritis, which also occurs in approximately 40% or 50%. So that is a similarity in terms of addressable patient population. The similarity, of course, is that we are no alternative drugs available for the treatment of pruritus. We're very proud that we are the drug with the first label for that population, and there's no alternative generics or other drugs that could substitute there. So that's a dissimilarity. So that may see additional momentum, we think, in the launch. In terms of the group we're working with, Chris has already emphasized how we see the V4 team and think they're the appropriate group to really provide a very efficient launch here. In looking for another example of what's achievable in the market space, particularly specifically dialysis space, the V4 team launched Mercera a number of years ago. and really saw a very significant uptake there, which was somewhat similar to that achieved by parsibiv. So we know they have the mechanisms and relationships that can really move product into that space. So that would be the similarity there. And, you know, we're really looking forward to getting this to the patients as quickly as possible in the first half of next year.
spk09: Great. If I could just ask one quick follow-up on the CLD trials and the nostalgia parasitica, the NP trials. Are you going to be pursuing those all the way through development, phase three, or just using it as a supplementation for possible, you know, use off-label, use as a broad antipyretic drug? How should we think about those two indications?
spk01: Yeah, so the present plan, Annabelle, is our two primary Phase III registration programs will be in atopic derm and non-dialysis-dependent CKD patients. That's where we're committed to pushing forward and getting those programs underway as soon as we can next year. And, you know, the data we're looking for in chronic liver disease patients and Natalia Parasetica is really to satisfy this idea that the mechanism of Kursuva is broadly applicable, and it's applicable regardless of the initiating pathophysiology that engenders the moderate to severe pruritus. And so our aim is to produce data across each of these major pathophysiological categories, and that includes neuropathic pruritus with NP and systemic pruritus or end organ disease pruritus with CLD that would be supportive of the idea that ultimately Cruciva injection, and sorry, oral Cruciva is a drug where a broader label would be more appropriate if we can see efficacy across all of these various patient populations. So presently, we don't have a plan to push forward with registration programs in either CLV or neuropathic itch. Great. Thank you. Thanks, Annabelle.
spk07: Next question is from Joseph Stringer of Needham & Company. Your line is now open.
spk03: Hi, this is Ben Rakarian for Joey. Just one question for Miles. Thank you for taking it, by the way. So this is for Chris. Based on prior commercial experience, what are some things that you can be doing to maximize profitability on IV courses as well?
spk06: Yeah, thanks for the question. I mean, we're going to be highly engaged with V4 as I think about kind of the priorities of this commercial launch, and I'll dig in with the team. You know, it's going to be around reimbursement. It's going to be around formulary and protocol placement and the dialysis organizations, and then promotional launch execution. We're going to be highly focused with V4 on those three priorities. And, you know, as we think about some of the kind of leading, you know, KPIs, key performance indicators we're going to monitor, are going to be right in line with those. We're going to really look heavily at the promotional excellence, you know, kind of the Salesforce reach and frequency. It's a highly concentrated audience. You know, roughly 4,000 nephrologists account for the majority of dialysis patients. And V4 has a strong, strong track record that Derek just alluded to in terms of their relationships with nephrologists. They are the world leader. So, We'll be monitoring that. We're going to clearly look at formulary acceptance across the dialysis clinics, not only the LDOs, but also the mid and smaller size. And then, you know, obviously some of the leading indicators around new patient starts. I mean, it's a very patient-centric drug. I mean, varitis is a chief concern in the hemodialysis clinics. So we're going to really be looking at kind of the strength of adoption, and we'll be monitoring new patient starts.
spk03: Okay, thanks.
spk07: You're welcome. Thank you, participants. Now, I'd like to turn it back over to Dr. Chalmers for closing remarks.
spk01: Okay, well, thanks, and thanks, everybody, for participating on today's call. I'd like to say it has been a distinct privilege to have led CARA for the last 17 years from an early stage research company to now on the verge of a commercial stage organization. And I'd like to thank the entire CARA team for all it's accomplished over this time and for their trust that they placed in me for those 17 years. And I look forward to continuing working with CARA in my new role as an advisor to the company and look forward to supporting Chris in his new role as a CEO. So thanks again for participating on today's call, and have a great night, everybody. Thank you very much.
spk07: Ladies and gentlemen, this concludes today's call. Thank you again for your participation. You may now disconnect, and have a great day.
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