Tvardi Therapeutics Inc (TVRD) 2021 Q3 法說會逐字稿

Good afternoon, and welcome to Cara Therapeutics' Third Quarter 2021 Financial Results Conference Call. (Operator Instructions) 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.

Good afternoon. This is Will Gramig with Stern Investor Relations, and welcome to Cara Therapeutics' Third Quarter 2021 Financial Results and Update Conference Call.

The news release became available just after 4:00 p.m. today and 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 Investors 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 KORSUVA injection, including the timing of additional regulatory submissions and approvals; the company's ability to maintain coverage and adequate reimbursement for KORSUVA injection; the performance of our commercial partners, including Vifor Pharma; expected timing of the initiation, enrollment and data readouts from the company's planned and ongoing clinical trials; the potential results of ongoing clinical trials; timing of future regulatory and development milestones for the company's product candidates; the potential for the company's product candidates to be alternatives and 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 time lines and plans.

Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Cara Therapeutics' filings with the Securities and Exchange Commission including the Risk Factors section of the company's most recent annual report on Form 10-K and its other documents subsequently filed with or furnished to the Securities and Exchange Commission.

All forward-looking statements contained in today's call speak only as of the date on which they were made. Cara Therapeutics undertakes no obligation to update such statements to 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 Reilly, Cara's Chief Financial Officer. I'll now turn the call over to Dr. Chalmers.

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 23 of KORSUVA 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, KORSUVA 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, Vifor Pharma, on preparation for the launch of KORSUVA injection in the first half of 2022.

We are also continuing to make important progress in our Oral KORSUVA programs and following guidance from the FDA aim to initiate Phase III programs with Oral KORSUVA 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 KORSUVA injection with great momentum in our Oral KORSUVA 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 adviser 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?

Yes. 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. And I believe in Cara's mission, to maximize the potential of our novel platform therapeutic, KORSUVA, 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 KORSUVA 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 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 Cara team and getting to work. So back to you, Derek.

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 KORSUVA injection. As we prepare for commercial launch, our partner, Vifor Pharma, is currently embarked on a sales force-driven Disease Day education program across the U.S. market in anticipation of launch next year. In addition, in September of this year, Vifor 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 KORSUVA injection and enable a commercial launch in the first half of next year.

As a reminder, Cara executed a strategic license agreement with Vifor Pharma in the fourth quarter of 2020 for the expanded commercialization of KORSUVA injection in all U.S. dialysis clinics. That agreement features a Cara 60%, Vifor Pharma 40% profit sharing arrangement in non-Fresenius 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 KORSUVA 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, Vifor Fresenius Medical Care Renal Pharma and Cara agreed to market KORSUVA injection to Fresenius Medical Care North America dialysis clinics in the U.S. who are approximately 40% of the U.S. market under a Cara 50%, Vifor Pharma, a 50% 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 KORSUVA 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 difelikefalin 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, Vifor Fresenius will be responsible for the commercialization of KORSUVA 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 KORSUVA pipeline. In Q2 of this year, we announced top line results from the KARE Phase II dose-ranging trial of Oral KORSUVA for the treatment of moderate-to-severe pruritus in atopic dermatitis patients. And this trial was a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Oral KORSUVA in 401 adult subjects with atopic dermatitis.

Patients in that trial were stratified across treatment groups by disease severity with 64% of patients characterized by mild-to-moderate atopic dermatitis, and approximately 36% of patients characterized by moderate-to-severe atopic dermatitis. And patients were randomized to 3 tablet strengths of Oral KORSUVA, 0.25 milligrams, 0.5 milligrams and 1 milligram taken BID versus placebo for 12 weeks, followed by 4 weeks of active extension.

Now the KARE results provided key information related to a defined patient group, an active dose range and very importantly, an effect size on the registration 4-point responder endpoint from which to design appropriately powered Phase III trials. With this data in hand, we held an end of Phase II 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 III program with Oral KORSUVA 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 III trials.

Moving on to our program in non-dialysis dependent CKD patients with moderate-to-severe pruritus. We conducted an end of Phase II meeting with the FDA in Q2 of this year with the goal of defining a Phase III program in these patients. At that time, the agency indicated the viability of Stage V pre-dialysis CKD patients as a population for that program.

We subsequently submitted pruritus incidents 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 V and the group of Stage IV predialysis patients with advanced CKD and a registration program consisting of 2 pivotal Phase III 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 notalgia paresthetica. 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.

Pruritus is a very common symptom of cholestatic liver diseases. 20% to 30% of these patients overall experience pruritus, with that number rising to approximately 70% of patients with primary biliary cholangitis. Our 16-week Phase II trial is designed to assess the safety and efficacy of a 1 milligram tablet strength of Oral KORSUVA taken twice daily versus placebo in PBC patients with moderate-to-severe pruritus. Primary endpoint is a change from baseline and the weekly mean of the daily 24-hour worst itch 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 patient enrollment resulting from the ongoing COVID-19 pandemic.

Finally, earlier this year, we initiated a Phase II proof-of-concept trial of Oral KORSUVA for the treatment of moderate-to-severe pruritus in patients suffering from notalgia paresthetica, a neuropathic disorder characterized by chronic pruritus of the upper to middle back. That Phase II multicenter, randomized, double-blind, placebo-controlled 8-week study is designed to evaluate the efficacy and safety of Oral KORSUVA for moderate-to-severe pruritus in approximately 120 subjects with notalgia paresthetica randomized to receive Oral KORSUVA, 2 milligrams twice daily, versus placebo for 8 weeks, followed by a 4-week active extension period. Primary efficacy endpoint is a change from baseline and the weekly mean of the daily 24-hour worst itch NRS score at week 8 of treatment.

Now I'm pleased to note that this trial has now passed the 70% 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 KORSUVA injection on deck and advancement of Oral KORSUVA into registration programs as well as anticipated Phase II readouts next year, 2022 -- or 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?

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 3 months ended September 30, 2021, net loss was $1 million or $0.02 per basic and diluted share compared to a net loss of $16.5 million or negative $0.35 per basic and diluted share for the same period in 2020. Total revenue was $20.3 million for the 3 months ended September 30, 2021 compared to $9.3 million during the same period of 2020. The company recognized $20 million license and milestone fees for the 3 months ended September 30, 2021 related to the regulatory milestones the company earned from Vifor and VFMCRP as the variable consideration was deemed probable upon the regulatory approval of KORSUVA injection in August 2021.

Of the $20 million earned, $15 million was from the VFMCRP 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 Vifor. The license fees revenue of $9.3 million for the 3 months ended September 30, 2020 was related to license fees earned by us in connection with the VFMCRP agreement.

Now turning over to our costs for the quarter. Research and development expenses were $15.5 million for the 3 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 Enteris during the third quarter in 2020, partially offset by increases in stock compensation expenses and payroll costs.

General and administrative expenses were $5.9 million for the 3 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 3 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 costs 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 Vifor and VFMCRP, 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.

(Operator Instructions) Speakers, our first question is from Jessica Fye of JPMorgan.

A couple here. Was it always expected that you would need 2 pivotal Phase III trials in the non-dialysis dependent CKD population? How long do you think it will take those trials to enroll?

Jess, thanks for that. So initially, in our initial interaction with the FDA, the guidance from the agency was that if that program was confined to Stage V dialysis -- Stage V 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 1 pivotal Phase III trial.

As you know, we've been interacting with the agency since that end of Phase II meeting discussing our data and epidemiological data that's published as to the similarity of Stage IV and Stage V patients and CKD patients. And our belief that, that represents a viable population for the Phase III program. So now that we have the extension from the agency to expand beyond Stage V to the portion of Stage IV patients, they see a more traditional program has been appropriate there with 2 pivotal Phase III trials. So that's what we're planning to conduct and get that program underway next quarter.

And how long do you think it will take them to enroll?

Well, I never like to guide to outcomes until we start the trials, Jess. So we'll 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.

Okay. And then how many trials will be in the atopic derm Phase III program? And lastly, just in light of all these pivotal studies starting up, how should we think about the ramp in R&D spending next year?

Yes. So the AD program is going to be traditional again, 2 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 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 KORSUVA injection or any milestones will be seen from either our U.S. license agreement with Vifor or our EU agreement with Vifor. So we're well positioned to run both programs.

Next question is from Chris Howerton of Jefferies.

Two from me, I think. One would be -- or maybe 3, actually. So first of all, with respect to the Stage IV 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 IV versus Stage V?

The second question would be, and I think if I'm remembering this right, Derek, and apologies if I'm not, was that KORSUVA or even Oral KORSUVA 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 in launch for Vifor and yourselves for the injectable KORSUVA, could you just remind us of what the time lines are for the TDAPA and the CMS coding? When you should hear back from those?

Yes. Great, Chris, thanks. You got 3-for there, 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 V and later Stage IV patients or Stage IV patients with advanced CKD. In the U.S., there's approximately 1.1 million U.S. patients in Stage IV at any time. The vast majority of these will progress to advanced Stage IV or indeed Stage V or some go straight into dialysis. In terms of pruritus incidents across that group of patients, it's approximately 30% at the moderate-to-severe level. And then Stage V NDD patients approximately 100,000 at any point in the U.S. and approximately 40% of those are seeing 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 incidents there. So that's the first thing on the patient population.

On your second question on PK/PD. Yes, you're entirely correct that difelikefalin or KORSUVA 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 a commercial launch next year. We have filed, as I said in our prepared remarks, we filed both our HCPCS or J-code 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.

That's great. Derek, maybe just one very minor clarification. For the Stage IV versus Stage V, are there any anticipated differences in dosing concentration or frequency?

No, none.

Next question is from David Amsellem of Piper Sandler.

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 a nephrology office setting or for atopic dermatitis to support dermatologic indication. Just wanted to get your thoughts. And are they any different than what Derek and the team have said previously regarding commercial infrastructure?

And then secondly, this is a really long-term question, 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 sales force verticals? Just in general, it's all under the umbrella of kind of where you want to take the company?

Yes. No, it's -- and thanks for asking those. I think the first question was around the commercial infrastructure build-out in the near term. And certainly concur with the team, I've been on the board, so I've been a part of a lot of these discussions. The first thing I'd say is we have a great partner in Vifor that they are taking. They're doing the full commercialization with KORSUVA injection. So we're pretty excited about that and partnering with them.

And I think that's some of the value I could bring working on the launch with not only our team at Cara, who we got a great commercial lead and then also working obviously with Vifor. So we'll be really focused on ensuring a successful launch of the KORSUVA injection with Vifor.

I think longer term, as we think about commercial infrastructure build-out, that's something that we'll look as we progress the data. Obviously, I spent a lot of time in dermatology over the last 4.5 plus years, that's an area I know well. We would certainly think about in years to come how we want to approach that market. I think the longer-term question is a really interesting question about 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 -- listen, end of the day for me, and I know for the Cara team, I mean we're laser-focused on being the world leader in chronic pruritus. That's why I joined the Board 3 years ago. That's really my motivation and my priorities initially in building out not only the KORSUVA injection launch but also really building out and accelerating the clinical programs.

The next question is from Annabel Samimy of Stifel.

I'm sorry if I missed it, but when your -- when you talk about the 2 CKD trials for Phase III, first, are they going to be simultaneous? And does that also include a safety, and that's what you said, it was going to require a 52-week safety. And to what extent can you pull from the IV safety database with the phase -- Stage IV patients in there?

And then the second question I had was, I guess, you've alluded to Parsabiv as a good launch proxy for another renal drug. And I'm just wondering what gives you that confidence? Has there been any other drug launches in dialysis that's seen that kind of uptick and why is Parsabiv the right proxy?

Thanks, Annabel. Yes, so on the CKD or the anticipated Oral CKD program, yes, we will most likely run those Phase III 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 III program as we design that.

What was your other question? Your -- Parsabiv as a model of...

As a launch proxy.

As a proxy, yes. I mean as you know, there are similarities with the Parsabiv story and our story and there are distinct dissimilarities. But as an example of what can be done and that's highly concentrated as you're well aware now, market space where really 2 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 relationship with Fresenius as part of our Vifor 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 pruritus, which also occurs in approximately 40% or 50%. So that is a similarity in terms of addressable patient population.

Dissimilarity of course, is there will be 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 Vifor team and think they're the appropriate group to really provide a very efficient launch here. And looking for another example of what's achievable in the market space, particularly specifically dialysis space, the Vifor team launched MIRCERA a number of years ago and really saw a very significant uptick there, which was somewhat similar to that achieved by Parsabiv. 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 we're really looking forward to getting this to the patients as quickly as possible in the first half of next year.

Great. If I could just ask one quick follow-up on the CLD trials and the notalgia paresthetica, the NP trials. Are you going to be pursuing those all the way through development Phase III or just using it as a supplementation for possible use -- off-label use as a broad antipruritic drug? How should we think about those 2 indications?

Yes. So the present plan, Annabel, is our 2 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 the data we're looking for in chronic liver disease patients in notalgia paresthetica is really to satisfy this idea of the mechanism of KORSUVA 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/and organ disease pruritus with CLD, that would be supportive of the idea that ultimately KORSUVA injection and -- sorry, Oral KORSUVA as 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 CLD or neuropathic itch.

Next question is from Joseph Stringer of Needham & Company.

This is [Ben Ricardo] on for Joey. Just one question from us. So this is for Chris, based on prior commercial experience, what are some things that you target be doing to maximize profitability on IV KORSUVA?

Yes. Thanks for the question. I mean, we're going to be highly, highly engaged with Vifor as I think about kind of the priorities of this commercial launch, and I'll dig in with the team. It's going to be around reimbursement, it's going to be around formulary and protocol placement in the dialysis organizations and then promotional launch execution. We're going to be highly focused with Vifor in those 3 priorities.

And as we think about some of the kind of leading KPIs, key performance indicators we're going to monitor, we're going to be right in line with those. We're going to really look heavily at the promotional excellence, kind of the sales force reaching frequency. It's a highly concentrated audience, roughly 4,000 nephrologists to account for the majority of dialysis patients. And Vifor 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 obviously, some of the leading indicators around new patient starts. I mean it's a very patient-centric drug. I mean, pruritus 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.

Thank you, participants. Now I'd like to turn it back over to Dr. Chalmers for closing remarks.

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 adviser to the company and look forward to supporting Chris in his new role as the CEO.

So thanks again for participating on today's call, and have a great night, everybody. Thank you very much.

Ladies and gentlemen, this concludes today's call. Thank you again for your participation. You may now disconnect, and have a great day.