Cara Therapeutics Inc (CARA) Q4 2020 Earnings Call Transcript

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Cara Therapeutics Inc (CARA -5.02%)
Q4 2020 Earnings Call
Feb 25, 2021, 4:30 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good afternoon, and welcome to CARA Therapeutics Fourth Quarter and Full Year 2020 Financial Results Conference Call. [Operator Instructions] There will be a question-and-answer session at the end. [Operator Instructions].

I would now like to turn the call over to CARA team. Please proceed.

Jack Hildick-Smith -- Investor Relations

Good afternoon. This is Jack Hildick-Smith with Stern Investor Relations and welcome to Cara Therapeutics' fourth quarter and full year 2020 financial results and update conference call. The news release became available just after 4:00 PM 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 expected timing of the data readouts from the company's ongoing clinical trials, the potential results of ongoing clinical trials, timing of future regulatory and development milestones for the company's product candidates, including the company's projected timeline for FDA review and potential approval and commercial launch of Korsuva IV. The potential for the company's product candidate to be alternatives in the therapeutic areas investigated, and the company's expected cash reach.

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 recently filed quarterly report on Form 10-Q, and its other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements made 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 in today's call are Dr. Derek Chalmers, Cara's President and CEO; and Cara's Chief Financial Officer, Thomas Reilly.

I'll now turn the call over to Dr. Chalmers.

Derek T. Chalmers -- Co-Founder, President, Chief Executive Officer & Director

Thank you, Jack. Good afternoon, everybody, and thanks for joining us on the call this afternoon. So despite the circumstances that we're all painfully aware of, 2020 was certainly a significant and very productive year for Cara, as we advance the late stage clinical development of our lead product candidate Korsuva for the treatment of pruritus across a range of patient populations.

Culminating as we announced today and the recent acceptance and filing of our NDA for Korsuva Injection for the treatment of pruritus and hemodialysis patients. Thus NDA filing marks a truly significant milestone for our company and most importantly for the large proportion of hemodialysis patients who suffer from this intractable, untreatable pruritus that is so detrimental to their quality of life.

And I'd like to thank the entire Cara team, who have worked tirelessly to bring this first-in-class therapeutic from in-house discovery through development to the completion of FDA filing. And we look forward to working with the FDA throughout the review process, and if granted priority review, potential approval and commercial launch in the second half of this year.

Now with respect to Korsuva Injection commercial launch, we were also very pleased to execute a strategic license agreement with Vifor Pharma in Q4 of last year for the commercialization of Korsuva Injection in US dialysis clinics. We believe that Vifor has established US nephrology sales force and productive relationships with US dialysis organizations who will provide a basis for increased launch momentum and adoption of Korsuva Injection in the US market. And I'll cover the details for that arrangement in a little bit.

Lastly, we also expanded our Oral Korsuva clinical development program with the initiation of a fourth Phase II trial in patients suffering from neuropathic related pruritus, specifically Notalgia Paresthetica patients. Evaluating the ability to treat pruritus of a neuropathic origin, in addition to our ongoing clinical development programs and systemic dermatological Chronic Pruritus will further support the use of Oral Korsuva as a future broad anti-pruritic agent.

Building on this momentum from 2020, in addition to protected approval on launch of Korsuva Injection in the second half of '21, we expect major clinical data readouts and advancements throughout the upcoming year. And on the call today, I will provide a brief update on each of our programs and what to expect throughout 2021.

Before I get to that, let me remind you that due to the ongoing COVID-19 pandemic and in accordance with the FDA's updating guidance for conducting clinical trials, we have 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. And I'm pleased to say that due to the entire CARA team's continuous dedication and hard work, we remain on track today to meet our main clinical and regulatory goals for the year and continue to enroll patients across ongoing Oral Korsuva trials.

So, getting to the program, starting with our lead program for Korsuva Injection and hemodialysis patients with CKD-associated pruritus. As a reminder, this is the patient population where there is significant unmet need with approximately 40% to 50% of patients suffering from moderate to severe pruritus with no therapies currently approved in the US or in Europe. We believe Korsuva Injection has potential to fundamentally change the treatment paradigm for these patients. With the NDA for Korsuva Injection now filed, we remain focused along with our US licensing partner Vifor Pharma on preparation for an anticipated US commercial launch as early as the second half of this year.

Now, as a reminder, under the terms of the Vifor license agreement, CARA received an upfront payment of $150 million composed of $100 million in cash and $50 million in equity purchase. Upon US approval, CARA is eligible to receive a further $50 million equity purchase and there is potential US commercial sales milestone of up to $240 million.

Vicor will have the exclusive rights to commercialize Korsuva Injection and non-Fresenius Medical Care North America dialysis clinics in the US under CARA 60%, Vifor 40% profit-sharing arrangement. And that's based on profit from net non-Fresenius Medical Care clinic sales. Recall from our original CARA Vifor Fresenius license agreement that we executed in 2018, we have an established 50-50 profit split arrangement in Fresenius clinics already in place for the US.

So overall, we see this as an ideal agreement, which allows us to both leverage Vifor's established commercial infrastructure and capabilities and retain commercial upside from our profit-sharing arrangement. Transition of both medical affairs and commercial launch activities to the Vifor teams have progressed well since we executed that agreement over the last two quarters and we are well prepared for a potential Korsuva Injection US launch as early as the second half of this year.

Moving on to our pipeline programs focused on Oral Korsuva. And let's start with our program in pre-dialysis CKD patients with moderate to severe pruritus. We have previously reported positive top line results from our 12-week Phase II trial evaluating the safety and efficacy of three tablets strengths of Oral Korsuva, 0.25 milligram, 0.5 milligram, and 1 milligram, once daily. Based on that data, we identified that 1 milligram tablet strength of Oral Korsuva has the dose level to take forward into Phase III. To that end, we will be conducting an end of Phase II meeting with the FDA in Q2 of this year, which will enable our projected pivotal Phase III trial initiation in the second half of 2021. Moving onto Atopic Dermatitis and our ongoing KARE Phase II dose-ranging trial. In Q2 of 2020, we completed a planned interim unblinded conditional power assessment conducted after approximately 50% of the originally targeted patient number completed the designated 12-week treatment period. Based on the independent data monitoring committee's recommendation and to maintain a conservative statistical power on our main endpoints, we increased the target trial size by approximately 28%. In Q4 of last year, we announced the trial was fully enrolled at approximately 400 patients, and we currently expect to readout topline data in the first half of this year. Finally, with the goal of further establishing the broad anti-pruritic applicability of Korsuva across patient populations we recently announced the initiation of a Phase II Proof-of-Concept trial for the treatment of moderate to severe pruritus and patients suffering from Notalgia Paresthetica or NP. It's a nerve disorder characterized by chronic pruritus of the upper to middle back. It's estimated that chronic pruritus effects up to 13% of the United States population, and about 8% of these patients suffer from some form of neuropathic edge including NP. There is currently no well defined treatment for NP, and conventional treatments such as anti-histamines and topical steroids are largely ineffective. So there remains a significant opportunity for Oral Korsuva as a novel therapeutic approach for these patients. So overall, our progress in 2020 has laid the foundation for a transformative year ahead at CARA. We very much look forward to the projected approval and commercial launch of Korsuva Injection in the second half of 2021, top line data readout from our KARE Phase II trial of Oral Korsuva and Atopic Dermatitis in the first half of '21. Initiation of our Phase III registration trials for Oral Korsuva in Stage 3 to 5 pre-dialysis CKD patients in the second half of this year, as well as continued progress on ongoing Phase II trials and liver disease patients and NP patients. And we will be bringing updates on the progress across all of these programs in the coming quarters. So with that, I'll now turn over to Tom to detail the financial results for the quarter and for the full year. Tom?

Thomas Charles Reilly -- Chief Financial Officer

Thank you, Derek. As a reminder, the full financial results for the fourth quarter and full year 2020 can be found in our press release issued today after the market closed.

For the fourth quarter of 2020, we reported net income of $78.9 million or $1.60 per basic share and $1.59 per diluted share compared to a net loss of $28.6 million or $0.61 per basic and diluted share for the same quarter of 2019. In the fourth quarter of 2020, we recognized revenue of $112.1 million of which $111.6 million related to the 2020 license agreement with Vifor and $0.5 million related to the license agreement with Vifor Fresenius. This compares to $4.5 million of license and milestone revenue during the fourth quarter of 2019, which related to the license agreement with Vifor Fresenius.

Research and development expenses were $27.1 million in the fourth quarter of 2020 compared to $29.9 million in the same period of 2019. The lower R&D expenses in 2020 were principally due to a net decrease in costs associated with clinical trials and travel costs, partially offset by a $2.5 million milestone payment made in connection with the license agreement with Enteris, increase in payroll and related costs and increases in stock compensation expense.

General and administrative expenses were $6.7 million in the fourth quarter of 2020 compared to $4.6 million in the same period of 2019. The higher G&A expenses in 2020 were principally due to increases in payroll and related costs, commercial costs and insurance costs. Other income was $0.4 million in the fourth quarter of 2020 compared to $1.2 million in the same period of 2019. The decrease in other income was primarily due to a decrease in interest income resulting from a lower yield on our portfolio of investments in the 2020 period.

Now turning to the full year 2020 financial results. For the full year ended December 31, 2020, we reported a net income of $8.4 million or $0.18 per basic and diluted share compared to a net loss of $106.4 million or $2.49 per basic and diluted share for 2019. Revenues for the year ended December 31, 2020 were $135.1 million as compared to $19.9 million in 2019. We recognized $134.4 million of license and milestone revenue for the year ended December 31, 2020, of which $111.6 million related to the 2020 license agreement with Vifor, $22.3 million related to the license agreement with Vifor Fresenius, and $0.6 million related to the achievement of milestones related to our license agreement with CKD Pharmaceutical. We recognized $19.7 million of license and milestone revenue for the year ended December 31, 2019, which related to the license agreement with Vifor Fresenius.

Research and development expenses were $107.9 million for the full year ended 2020 compared to $113.8 million for the full year ended in 2019. The lower R&D expenses in 2020 were principally due to a net decrease in clinical trial costs, lower payments made to Enteris and a decrease in travel costs, partially offset by increases in stock compensation expense, payroll and related costs and cost of clinical compound sales.

General and administrative expenses were $21.8 million for the full year ended December 31, 2020 compared to $17.7 million for the full year ended December 31, 2019. The increase in 2020 was primarily due to increase in commercial costs, insurance costs, payroll and related costs, and partially offset by a decrease in consulting costs. Other income was $2.3 million for the full year ended 2020 compared to $4.5 million for the full year ended 2019. The decrease in 2020 was primarily due to a decrease in interest income, resulting from a lower yield on our lower average balance of our portfolio of investments in 2020.

As of December 31, 2020, our cash, cash equivalents and marketable securities totaled $251.5 million compared to $218.2 million at the end of 2019. The increase in the balance resulted primarily from a $38.4 million from the sale of common stock in the license agreement with Vifor, partially offset by $5.5 million of cash used in operating activities, which includes the $111.6 million of cash received under the Vifor agreement, which was recorded as license and milestone revenue.

Turning to our financial guidance, based on the projected costs for our clinical development plans and timing expectations, we expect that our current cash, cash equivalents and marketable securities as of December 31, 2020 will be sufficient to fund our operations into 2023, not accounting for any potential milestones or potential product revenue under existing collaborations.

I will now turn the call back over to the operator for Q&A.

Questions and Answers:

Operator

[Operator Instructions] Your first question comes from the line of David Amsellem from Piper Sandler. Your line is open. Mr. David Amsellem, your line is open.

Derek T. Chalmers -- Co-Founder, President, Chief Executive Officer & Director

We can move on. Its obvious It's obvious David has a problem there. Maybe he solves that we go back then.

Operator

Your next question comes from the line of Annabel Samimy with Stifel. Your line is open.

Avatar Jones -- Stifel -- Analyst

Hey, everyone. This is Avatar on for Annabel today. A couple of questions from us. Firstly, with the NDA filing for IV Korsuva accepted in February, when do you expect to know whether the drug is granted priority review? And secondly, are you able to provide an update on progress made by Vifor on TDAPA reimbursement discussions? And does the fact that there are numerous renal drugs seeking to that inclusion make these discussions any more difficult?

Derek T. Chalmers -- Co-Founder, President, Chief Executive Officer & Director

Okay. Hi, Avatar. Thanks for that. Yes. So on the first question on the NDA. So we had confirmation from the FDA this week electronically that the NDA was accepted and filed, but within that confirmation for filing the FDA also indicated that the official filing letter was still in process. So that was in process. We have not yet received that letter. And therefore, we don't yet have information on priority review or indeed the PDUFA date. So we expect that letter to arrive soon. But the FDA being the FDA, there is no prediction on timing yet unfortunately.

On the reimbursement question, of course, you're aware that TDAPA reimbursement is not discretionary. We qualified for TDAPA reimbursement by meeting the criteria that are legislatively defined in the ESRD legislation. So we're across when NDA were approved after January 2020. And we're going to be used in the dialysis setting. So that we're very confident upon and we have a good team at CARA who continues to lead our interactions with CMS and discussions, not only related to TDAPA, but reimbursement beyond TDAPA. Now, we started to include our partner there in those discussions and they will obviously enter as we progress those discussions. But TDAPA is something we qualify for and we will be applying for that after we get approval of Korsuva Injection.

Avatar Jones -- Stifel -- Analyst

And does the sort of desire for many companies to be included into that look sort of complicate those discussions or timelines?

Derek T. Chalmers -- Co-Founder, President, Chief Executive Officer & Director

Well, I don't think so. The way the legislation was defined was to encourage innovation for hemodialysis patients and if those companies' compounds meet those criteria for an innovative compound for the treatment of hemodialysis patients, then they would qualify for TDAPA.

Avatar Jones -- Stifel -- Analyst

Got it.

Derek T. Chalmers -- Co-Founder, President, Chief Executive Officer & Director

Okay, Avatar.

Avatar Jones -- Stifel -- Analyst

Thank you, Derek.

Derek T. Chalmers -- Co-Founder, President, Chief Executive Officer & Director

Thank you too.

Operator

Your next question comes from the line of Christopher Howerton from Jefferies. Your line is open.

Brian Mills -- Jefferies -- Analyst

Hi, everyone. This is Brian Mills on for Chris here. So I have two questions. The first one is, if you could speak a little bit about the dosing decisions in the CKD, AD and neuropathic pain studies? And whether this corresponds any differences in disease severity? So specifically, we're interested in what led to your decision to choose 2 milligrams versus 1 milligram twice daily in the neuropathic pain study.

The second question would be around, if there's any relevant differences in the characteristics or underlying biology resulting in pruritus in the CKD and AD populations? And what the key supportive evidence is, that gives you confidence for success in AD? Thanks so much.

Derek T. Chalmers -- Co-Founder, President, Chief Executive Officer & Director

Yeah. Thanks, Brian. The dosing question is actually really related to PK and availability of the drug. So for the CKD studies, oral studies, as you know, KORSUVA is eliminated almost entirely via the kidney.

And so, we looked at the PK exposures, and specifically Stage 3 to 5 CKD patients to define what tablet strength and frequency of dosing would match the AUCs, we know were highly efficacious from our IV studies. And that's why we come up with the dose of 1 milligram qd for the CKD patients.

When we move to atopic derm there, those patients, of course, have normal kidney function. And so to meet -- and again, we look to the PK and normal individuals and to match that desired AUC, there we needed to get twice-a-day dosing at the 1 milligram level. So that was the rationale, really on those two studies.

On the notalgia paresthetica, we really view this as a proof-of-concept trial. And we know, particularly in preclinical models, looking at neuropathic pain, different modality, but actually same system in terms of peripheral nerve transmission via the DRG, that we require slightly higher drug dosage in those neuropathic type models. And so that was partially the rationale behind pushing up the doors there when we look at neuropathic related pruritus. And, also, as a proof-of-concept trial, we'd rather use a higher dose and see what level of efficacy we can achieve their single dose. And as you know, we've dosed this drug up to 10 milligrams a day orally with no safety concerns. So it's well within the range we've used before.

And then you're -- your second 30,000-foot question on mechanism, we've indicated this a few times. I think, when we look at the mechanism for KORSUVA, actually related to activation of kappa receptors directly on the C fibers and the epidermis and dermal, the relay of the pruritus. That mechanism is really agnostic to the initiating pathology. So whether that's a CKD and organ disease, and we know the cytokine profile there, and it's certainly different in the dermatological inflammatory state. That really should make a difference based on our mechanism of action to efficacy.

And that's certainly something we've seen in preclinical models of various pathologies. And we've took this drug all the way to transgenic models associated with, for example, atopic dermatitis and showing good efficacy in those validated predictive models. So we have high confidence in the mechanism there, we should really be agnostic to the initiating pathophysiology. But we don't -- the good news, Brian, as we don't have too long to wait to actually get the answer on that empirically. So that's upcoming, and we're looking forward to that.

Brian Mills -- Jefferies -- Analyst

Great. That's helpful. Thank you.

Derek T. Chalmers -- Co-Founder, President, Chief Executive Officer & Director

Thanks, Brian.

Operator

Your next question comes from the line of Jason Gerberry from Bank of America. Your line is open.

Jason Gerberry -- Bank of America -- Analyst

Hi, guys. Thanks for taking my questions. Yeah, I guess, they're just kind of curious to get your thoughts, Amgen's update on Parsabiv kind coming out of the TDAPA space guiding to, I think, a 40% or 50% year-over-year decline in revenue. Is this how investors should be thinking about sort of drugs coming out of this TDAPA space, where there's maybe a better price point, just kind of trying to reconcile that versus the CARA's consensus where there's growth in year three and year four of the launch? But just wondering, how to think about that price reset dynamic that we've talked about in the past.

And then, second question is just curious about -- thinking about the Parsabiv launch a little bit more closely, wondering if you have any perspective on why the uptake was low with large dialysis organizations versus small dialysis organizations. Is there a concern among the LDOs, that once you start using these medications, it's difficult to kind of pull back in the copay component? This could be something that the LDOs typically absorbed. So wondering, if you can comment on those two dynamics that we start to think about commercial here? Thanks.

Derek T. Chalmers -- Co-Founder, President, Chief Executive Officer & Director

Yeah. Thanks. Thanks, Jason. I think the first thing to see right up front that you're well aware of Jason, that Parsabiv was an entirely different class here, and directed at an entirely different issue associated with dialysis patients, for which there are existing alternatives already out there, and including [Indecipherable]. So I think that has a lot to do with the point you're raising on revenue decline, as the availability of a number of alternatives out there that are quite frankly much cheaper than Parsabiv was, that will not be the case with KORSUVA, as you know, we're a breakthrough drug. We're really going to be the first drug approved for CKD pruritus. And there are no alternatives for efficacious, certainly nothing we've seen very effective in an RCT in that patient population. So I think, it's quite a bit of apples and oranges there in terms of Parsabiv change for TDAPA.

Your question related to the views of LDOs versus the more midsize and independent dialysis organizations. Again, I think, Parsabiv might be specific -- has specific issues related to those, I can't really speak to the smaller organizations, we don't really have their view, but as you know, we've worked with Fresenius for a couple of years, and we know the enthusiasm that they've relayed, and the need for this therapeutic for their patients. And as you know, they're all striving as part of their assessment on reimbursement to improve patient standard of care. And they see this as a huge unmet need, and they're very keen to get involved and moving this drug along.

So, that doesn't answer the question to the independence and the differentiation there with Parsabiv. But we know from our experience with a large dialysis organization. They're very keen to get in with KORSUVA and use the drug. And of course, they have their own databases related to prevalence of pruritus within their patients.

Jason Gerberry -- Bank of America -- Analyst

Okay, great. Thanks so much for the useful insights.

Derek T. Chalmers -- Co-Founder, President, Chief Executive Officer & Director

Great. Thanks, Jason. Thanks for the questions.

Operator

[Operator Instructions] Your next question comes from the line of Joseph Stringer from Needham & Company. Your line is open.

Joseph Stringer -- Needham & Company -- Analyst

Hi, everyone, thanks for taking our question. I was wondering if you could detail there the -- where Oral KORSUVA or atopic dermatitis, where do you see that fitting into the current treatment paradigm? And then, as a follow up for the upcoming Phase II readout, is it fair to think about comparisons to some of the Phase II data from the oral JAK in terms of itch NRS reduction and also a 4-point improvement in Itch NRS response rates? Thank you.

Derek T. Chalmers -- Co-Founder, President, Chief Executive Officer & Director

Great. Thanks, Joe, and congrats on the new position at Needham. Yeah, so when we think about atopic dermatitis, of course, provided this is the defining symptom for that disorder. And that level of pruritus, high level of pruritus occurs really regardless of the degree of pathophysiology there. So we can recruit and have done in our clinical trials, patients with very high levels of pruritus is only qualifying this moderate-to-severe whether they have mild-to-moderate pathology associated with their atopic dermatitis or indeed moderate-to-severe pathology. So this is a primary symptom across the whole spectrum of atopic dermatitis.

Today's therapeutics for the mild-to-moderate are really confined to topical medications. And the medication has been developed in the atopic that are beyond topical. Of course, we have difelikefalin approved as a IL-4, IL-13 biologic, and we have the JAK inhibitors, as you indicate coming through are really targeting the moderate-to-severe pathology, that's their niche, that's where they're going to be reimbursed. And that's where dermatologists are most likely to be willing to use those and accommodate the associated safety risks that are going to issue from both biologics and particularly JAKs.

So those molecules coming through are really focused on about 20%, roughly, of the US atopic dermatitis population. KORSUVA, on the other hand, we see positioned has been broadly applicable from mild-to-severe pathology, so it's a much broader applicability. And, frankly, we see it particularly in the mild-to-moderate population has been a candidate for first line therapy. There may be after some topical usage or in combination with the topical.

In the moderate-to-severe range, again, I think it could be monotherapy for those patients. And also, theoretically combined with any other modalities, biologics or JAKs, for the more severe patients, and as you know, we've talked about a number of times there's no antimetabolites with this drug. It's excreted whole via the kidney. There's no potential for drug-drug interaction. We can see those used in combinations with any other classes of medications. So that's how we see it being positioned as a much broader applicability potential first line therapy for the whole of the AD populations.

And then getting to the AD readout, yes, we will be-I think, we've discussed this before in the dermatological situation. It certainly dogma of the derm division at a 4-point responder analysis would be the appropriate registration endpoint. We're certainly looking at that as one of our major endpoints in the atopic derm trial. And as you know, we designed our interim analysis focused on a 4-point as well as our mean NRS change from baseline. So we are looking at that readout in terms of level of response, I think depicts them is in the 40% responder rate, some of the JAKs are a little higher, but really only at the very highest of dosages for those compounds, they may creep into the 50%.

So a win for us is separation from placebo that's our primary end here. And again, this is sort of an entirely different profile. So we'd like to see a nice appropriate biological window here. But again, we're looking for orally available, and well tolerated safe medication, which is really something that, as you well know dermatologists are looking toward as the desire profile for that patient population. So efficacy, but with improved safety is going to be the profile that's going to win against, particularly JAKs that are coming through for the moderate-to-severe population. Does that help position where we see this, Joe?

Joseph Stringer -- Needham & Company -- Analyst

Yeah, that's great. Thanks for the detail.

Derek T. Chalmers -- Co-Founder, President, Chief Executive Officer & Director

Thanks for the question.

Operator

Your next question comes from the line of David Amsellem from Piper Sandler. Your line is open.

David Amsellem -- Piper Sandler -- Analyst

Yeah, thanks. Thanks, David. I guess I'm glad you're back on the line. So in terms of the Phase III design, I'm hesitant to go too far into that. As you know, we haven't yet had an end of Phase II. And we're awaiting our readout from our dose ranging trial. We have started to think about that and prepare for that.

And we do see that as a normal Phase III program for a chronic use drug and we are planning two simultaneous US trials. I can't tell you the ultimate size of those, because I need my Phase II data to look at effect size there. But that's our thoughts and exposures that would be in line with ICH guidelines for chronic-use medication.

At this point, we're not-again, I don't want to get into promising not to do something and then try guessing with the FDA. But at this point, we're not planning on extensive trials, including co-administration of other medications. And that might be something that comes up particularly with topicals. But at this point, we're not particularly planning on that.

And then, I guess, the easier question for your first-answer for your first question on the Phase II design, yeah, we watch and have watched these patients that evolve medications as an entry criteria into the Phase II trial. So that's really as a pure monotherapy trial with no influence of background medications there.

And if anyone did take systemic risk there, they would be dropped from the efficacy calculation for that trial. So that is going to be a pure trial with no co-medications there for the patient. Okay, great. Thank you.

Derek T. Chalmers -- Co-Founder, President, Chief Executive Officer & Director

Thanks, David.

Operator

Your next question comes from the line of Ben Shim from Canaccord. Your line is open.

Ben Shim -- Canaccord -- Analyst

Hi, thanks for taking my questions and for all the details on the clinical development. I just have a quick question. And maybe you may not be able to answer this. But what is your sense of vaccine uptake among trial center employees, personnel and maybe prospective of Oral KORSUVA trial patients or even currently enrolled ones? I'm just wondering if the increased supply that's expected to come on board over the next few weeks could be a tailwind for your expectations on enrollments.

Derek T. Chalmers -- Co-Founder, President, Chief Executive Officer & Director

Thanks, Ben. I think you're right, on your assumption that I'm not sure I can answer that question for you. I am not even sure we've looked at that particular metric in our clinical trials. So I really don't know what the vaccine uptake is at this point in our trials. It may be something we learn at the end of the day for our ongoing trials, but I really don't have any data on that metric right now.

Ben Shim -- Canaccord -- Analyst

Okay. Maybe a question for Tom. Looking forward to commercialization, what level of visibility will we have on the underlying IV KORSUVA sales, both U.S. and ex-U.S.? I understand that we're going to be seeing profit share, revenue reported in the top-line. I'm just wondering if there's going to be other confirmatory data available.

Thomas Charles Reilly -- Chief Financial Officer

Sure. Thanks, Ben. So as Vifor will be recognizing the top-line revenue on their side, so net sales will be recorded on their books. So there'll be visibility on that end. And correspondingly, based off the profit share that we receive back, that will be recognized as revenue on our end. So there'll be visibility into the revenues based for that mechanism.

Ben Shim -- Canaccord -- Analyst

Okay, great. Thank you very much.

Thomas Charles Reilly -- Chief Financial Officer

You're welcome.

Operator

[Operator Instructions] There are no more questions at this time. Turning the call back over to Dr. Derek Chalmers.

Derek T. Chalmers -- Co-Founder, President, Chief Executive Officer & Director

Okay, thank you. Thank you, everybody, for participating in the call today. I'd also again like to thank the Cara team, our study investigators and all the patients who continue to participate in our ongoing clinical trials and we look forward to updating you again very soon. Thank you very much and have a good night.

Operator

[Operator Closing Remarks]

Duration: 46 minutes

Call participants:

Jack Hildick-Smith -- Investor Relations

Derek T. Chalmers -- Co-Founder, President, Chief Executive Officer & Director

Thomas Charles Reilly -- Chief Financial Officer

Avatar Jones -- Stifel -- Analyst

Brian Mills -- Jefferies -- Analyst

Jason Gerberry -- Bank of America -- Analyst

Joseph Stringer -- Needham & Company -- Analyst

David Amsellem -- Piper Sandler -- Analyst

Ben Shim -- Canaccord -- Analyst

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