Q3 2021 Cara Therapeutics Inc Earnings Call

November 8, 2021

Thank you for standing by the conference will begin momentarily until such time, you will hear music. Thank you and please continue to standby.

[music].

Good afternoon, and welcome to Cara Therapeutics third quarter 2021 financial results Conference call.

All participants are now in a listen only mode.

There will be a question and answer session at the end. Please be advised that this call is being recorded at terrorists request.

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

Good afternoon. This is will grant Nag 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 four P. M. Today and can be found on our website at www Dot Cara Therapeutics Dot com.

You May also listen to a live webcast and replay of today's call on the investors section of the website before.

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 <unk> injection include.

The timing of additional regulatory submissions and approval the company's ability to maintain.

Coverage and adequate reimbursement for of course is that injection.

Performance of our commercial partners, including before 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 companys product candidates to be Alt.

It is in therapeutic areas investigated the companys 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 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.

Yeah.

Therapeutics undertakes no obligation to update such statements to reflect events that occur where 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 carriers, incoming President and Chief Executive Officer, and Mr. Thomas Reilly Harris, 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.

Terra has had a truly transformation transformative third quarter. This year highlighted by the FDA approval on August 23rd of Tresiba 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 Tresiba 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 V for pharma on preparation for the launch of cursive injection in the first half of 2022.

We are also continuing to make important progress in our oral cursive of programs and following guidance from the FDA aim to initiate phase III programs with oral <unk> 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 and carriers development with the anticipated U S. Commercial launch for Christmas event injection with great momentum and are oral cursive a franchise as we plan to move into registration programs and with a strong balance sheet in place, allowing us to <unk>.

And all of 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.

Chris Posner, we'll move on to the President and CEO possession.

Now having worked closely with Chris since he joined Cara as a board member I am 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.

Yeah, Thanks, Derek I am really thrilled to be joining such an inspiring team.

As Chief Executive Officer to lead terror into its next phase as a commercial stage biopharmaceutical company that I originally joined care in 2018 as Derek said is as a board member as a director over the past years I've worked closed.

With the entire team care team in this capacity that I believe in carrots and mission to.

Maximize the potential of our novel platform therapeutic foreseeable 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 wanted to take a quick moment just to express my gratitude to the board of directors, replacing its trust in me to lead the company and I really want to thank Dirk for his support during this transition period from co founding the company through to the FDA approval of course Suva injection his contributions.

Take care of our indelible and I really look forward to ensuring a smooth leadership transition with his support and building on the amaze 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 get them to work so back to you there.

Great. Thank you Chris No 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 pursue that injection.

As we prepare for commercial launch our partner would be for pharma is currently embarked on a sales force driven disease State education program across the U S market in anticipation of launch next year. In addition in September of this year before.

Pharma and Cara submitted the required documentation for both to DARPA and reimbursement code to the U S centers for Medicare and Medicaid services to secure timely reimbursement and patient access to pursue the injection and enable our commercial launch in the first half of next year.

As a reminder, Cara executed a strategic license agreement with V for pharma in the fourth quarter of 2020 for the expanded commercialization of <unk> injection in all U S dialysis clinics.

That agreement features a carrot, 60% before farm, a 40% profit sharing arrangement and non Fresenius medical care clinics in the U S, which is approximately 60% of the total market and.

And under the terms of the agreement in October of this year upon U S regulatory approval of Tresiba injection. The company received a 50 million common stock investment at a 20% premium to the 30 day trailing average of cows common stock price and.

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.

For Fresenius medical care renal pharma and Kara agreed to market pursue that injection to Fresenius medical care North America dialysis clinics in the U S. We are approximately 40% of the U S market under our current 50% fee for farm of 50% profit share arrangement and.

Under this agreement in October of this year, we received an additional $15 million cash paying $15 million cash payment earned based on U S regulatory approval of pursue the 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 died fairly careful in injection for the treatment of pruritus associated with chronic kidney disease, and hemodialysis patients and the E M able review the applet.

<unk> under the centralized marketing authorization procedure under our 2018 license agreement V for Fresenius will be responsible for the commercialization of <unk> injection across European territories with Cara eligible to receive tiered double digit royalty payments based on annual net sales.

And up to $440 million and tiered commercial milestones all of which are sales related.

The MAA is expected to render a decision in the second quarter of 2022.

So turning now to progress in our oral cursive a pipeline.

In Q2 of this year, we announced top line results from the care phase two dose ranging trial of oral <unk> for the treatment of moderate to severe pruritus in atopic dermatitis patients.

Our next trial was a randomized double blind placebo controlled study designed to evaluate.

Evaluate the efficacy and safety of oral <unk> and 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.

Approximately 36% of patients characterized by moderate to severe atopic dermatitis and patients were randomized to three tablet strengths of oral cursive up two five milligrams <unk> five milligrams and one milligram taken b I D versus placebo for 12 weeks, followed by a four weeks of.

Active extension.

Now that the care results provided key information related to a defined patient group and active dose range.

Very importantly, an effect size on the registration four point responder endpoint from which to design appropriately powered phase III trials with that data in hand, we held an end of phase II meeting with the FDA in Q3 of this year and I am pleased to announce that based on guidance from that meeting we aim to initiate a phase three.

Program with oral <unk> for.

For the treatment of moderate to severe pruritus in a DPA should patients in Q1 of next year.

And we will announce more details around the design and composition of that registration program. When we initiate the phase III trials.

Moving onto our program and non dialysis dependent <unk> patients with moderate to severe provide us.

We conducted an end of phase two 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 five pre dialysis <unk> 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 five.

And the group of stage for pre dialysis patients with advanced CK D and a registration program consisting of two 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 Natasha Parenthetic.

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 call a static liver diseases, 20% to 30% of these patients overall experience pruritus with that number rising to approximately 70% of patients with primary biliary cholangitis or 16 week phase II trial is designed to assess.

The safety and efficacy of a one milligram tablet strength of oral <unk> 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 itch <unk> score at week 16.

And now expect to report top line data from this study in the first half of 2022 due to delays in site initiations and in 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 <unk> for the treatment of moderate to severe pruritus in patients suffering from Intouch pyrostat acre neuropathic disorder characterized by chronic pruritus of the upper middle back.

That phase III multicenter randomized double blind placebo controlled eight week study is designed to evaluate the efficacy and safety of oral pursuit of a moderate to severe pruritus and approximately 120 subjects with Natasha Pyrostat acre.

Randomize to receive oral care silver two milligrams twice daily versus placebo for eight weeks, followed by a four week active extension period.

Primary efficacy endpoint and this is changed from baseline in the weekly mean of the daily 24 hour worst itch <unk> score at week eight of treatment.

Now I'm pleased to note that that 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 a carryout during the third quarter and in recent months I believe lays the foundation for a very successful upcoming year.

With U S commercialization of <unk> injection on deck and advancement of oral chris's enter registration programs as well as anticipated phase two readouts next year 2022, or 2022 promises to be a catalyst rich year and the ongoing development.

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.

Timber 32021 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.

$58 8 million, partially offset by proceeds of $1 $3 million from the exercise of stock options.

For the three months ended September 32021, net loss was $1 million or two cents per basic and diluted share.

Compared to a net loss of $16 five or negative 35%.

<unk> per basic and diluted share for the same period in 2020.

Total revenue was $20 3 million for the three months ended September 32021.

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 32021.

Related to the regulatory milestones the company earned from before and V F.

CRP.

As the variable consideration was deemed probable upon the regulatory approval of <unk> injection in August 2021.

Of the 20 million earned.

$15 million was from the V F M CRP agreement related to the cash milestone with the regulatory approval.

5 million represented a 20% premium.

Within the $50 million equity milestone investment under the agreement with before.

The license.

Fees license fees revenue of $9 3 million for the three months ended September 32020 was related to license fees earned by you or by us in connection with the VA and 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 30th 2021 compared.

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 and tariffs during the third quarter in 2020.

Partially partially offset by increases in stock compensation expenses.

And payroll costs.

General and administrative expenses were $5 nine for the three months ended September 32021.

Compared to $5 2 million in the same period of 2020.

The higher G&A expenses in 2021.

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 32021, compared to <unk> 4 million in the same period of 2020.

The decrease in other income was primarily due to a decrease in interest income.

Our 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 32021.

Including the milestone payments received in October 2021 of $65 million from before and V. F M CRP.

It 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.

For Q&A.

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, Thats star one to ask a question.

Or the pound key to withdraw your request.

Okay.

Speakers. Our first question is from Jessica Fye of Jpmorgan. Your line is now open.

Hey, guys. Good afternoon, Thanks for taking my question.

Couple here was it always expected that you would need two pivotal phase III trials in non dialysis dependent <unk> population, how long do you think it will take those trials to enroll.

Yes, hi, Jeff Thanks for that you know so.

Initially in our initial interaction with the FDA.

The guidance from the agency was that if that program.

Was confined to stage five dialysis stage five non dialysis dependent <unk> patients than the similarity there and their opinion was so high.

Hi to hemodialysis patients that it may be possible to conduct that program with one pivotal phase III trial.

As you know we've been interacting with the agency since at the end of Phase II meeting discussing them.

Our data and epidemiological data.

Published as to the similarity of stage four and stage five patients.

C J D patients.

And our belief that that represents a viable population for the phase III program. So now that we have the essentially from the agency to expand beyond stage five.

Two the portion of stage four patients.

D C at more traditional program.

Been appropriate there with two pivotal phase III trials. So that's what we're planning to conduct and get that get that program underway next quarter.

And how long do you think it'll take them to enroll well.

I never like to get Oh.

It comes just a week until we start the trials Jess So we see how the enrollment is going.

So that's what we will do once we get the trials underway and we have.

You know at least a quarter under our belt and look at enrollment rates. Then we will guide us to when we see when we see output.

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.

Yes, so the <unk> program is gonna be traditional again two.

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 gonna 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 the various.

Strong balance sheet, we can we can certainly.

Move on all of these programs simultaneously and still see runway at this point through.

Through 2023, and that's not assuming any upcoming profit share of income from the launch of cursive injection or any milestones will be seen from either our U S license agreement with <unk> for our EU agreement with the four so we're well positioned to run both programs.

Thank you.

Thanks Jess.

Next question is from Chris Howerton of Jefferies. Your line is now open.

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 for CK D 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 is and I think if I'm remembering this right Derek and apologies if I'm not was that of course Hoover, even oral course Hoover is reasonably excrete it.

So if that's true how should we be thinking about.

The dosing concentration of frequency.

Towards the less renal 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 <unk> for.

The four and yourselves for the injectable courses.

Could you just remind us of what the timelines are for the <unk> and the CMS coding.

When you should hear back from those thank you.

Yes.

Hey, Chris Thanks, Thanks, you've got a three for there that's good.

So in terms of the non dialysis dependent <unk>.

<unk> patients and the numbers there.

So as I said the agency has not yet at that program.

Would it be appropriate including both stage five.

On later stage four patients who have stage four patients with advanced CK D.

And the U S is approximately one 1 million U S patients in stage four at anytime.

Vast majority of these will progress to advance stage for R&D stage, five or some go straight in to dialysis.

In terms of pruritus incidents across that group of patients. It's approximately 30% at the moderate to severe level and then stage five and D D patients.

Only 100000 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 thinking about those as you look at your modeling.

This is our addressable patient population, that's actually slightly bigger.

The hemodialysis population when we think of moderate to severe pruritus incidents. There. So that's the first thing on the on the patient population on your second question on PK PD, Yes, you're entirely correct.

Diphenyl, a caf one of Chris's excrete hole 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 <unk> patients so we know them.

What exposures, we can achieve with with appropriate dosing there and the appropriate dosing based on not PK analysis is cued is QD. So it's a once a day dosing in the <unk> patients, which contrasts with the.

Well the a D program of course with those patients have.

Normal kidney function and that we're looking at B I D.

And then.

On on making sure we're prepared for commercial launch next year, we have filed as I said in our prepared remarks, we filed both our <unk> or J code onto diaper applications actually in September of this year.

We've been working very closely with CBS CMS and I. Thank the Cara team has really done a great job and let us.

For a number of years now and based on those interactions we expect to hear back from CMS by.

By year end on those applications and.

That will allow the implementation in the first half of 2022.

So that's the timing in relation to commercial launch on those.

That's great.

Maybe just one very minor clarification for the stage four versus stage five are there any anticipated differences in dosing concentration or frequency.

No.

Okay.

Alright, well, thank you very much for taking the Forfar.

Thank you Chris.

Okay.

Next question is from David <unk> of Piper Sandler Your line is now open.

Thanks, So just actually had a COO.

Couple of questions.

Chris.

So just looking ahead longer term at the.

At the business what are your thoughts on.

<unk>.

Potential build out of commercial infrastructure, whether it's in.

In Nephrology also surveying.

Topic dermatitis.

To support to support a dermatological indication just wanted to get your thoughts on are there any different than what.

What Derek and the team had said previously regarding commercial infrastructure and then no.

Secondly.

This is this is a really long term question, but.

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 are you just looking at multiple indications of building out different salesforce verticals.

Just in general it's all under the umbrella of kind of.

Where do you want to take the company. Thanks.

Yeah, no it's and thanks for asking that is I think the first question was around the.

The commercial infrastructure Buildout in the near term.

Hugh.

And certainly concur with the team I've been on the board.

Been a part of a lot of these discussions.

First I would say is we have a great partner.

For.

They are taking they're doing the full commercialization.

With <unk> 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 on the launch with with not only our team at Cara, who we got it.

Great.

Actual lead and then also working obviously with before so we'll be really focused on ensuring a successful launch of the course of injection would be for I think longer term as we think about commercial infrastructure build out as something that will look as we progressed the data.

Obviously I spent a lot of time in dermatology over the last four or five plus years, that's an area I know well, we would certainly think about.

Sure.

And in years to come and how we approach that market I think the longer term question and it's a really interesting question about.

Obviously utilizing that commercial infrastructure, if and when we do build out.

Two to look at other Adjacencies, that's always a possibility, but I kind of listen the end of the day for me and I know for the Cara team I mean, we are 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.

My priorities initially and building out not only the courses injection launch but also.

Really building out and accelerating our clinical programs.

Okay.

Thanks, David.

Thanks, David next question is from animal Scamming of Stifel. Your line is now open.

Hi, guys. Thanks for taking the question.

I'm, sorry, if I missed it but when you are when you talk about the two trials.

Uh huh.

For phase III, Firstly, I think going to be simultaneous.

And does that also include safety I missed a few.

Fire safety.

What extent can you call from the IV safety database with the case.

Page four patients in there.

And then the second question I had was.

I guess, you've alluded to parse it that it was a good launch proxy.

For another green on track and I'm, just wondering what gives you that confidence that there had been any other drug launches in dialysis that seen that kind of uptake.

Right right.

Thanks.

Thanks Annabel.

Yes, so on the <unk> or the anticipated.

Oral CK D program, yet we will most likely run those phase III trials.

<unk>.

Obviously, we're looking to.

Advance that program as rapidly as possible and we will have extensions on each of those trials that will bring us the required safety numbers, which you are familiar with or a chronic indication.

Of course, I think we will be referencing our IV data.

As part of that safety database.

We won't be relying on that we'll make sure we get the IC H.

Appropriate numbers from our phase III program as we've designed that.

What was your other question.

<unk> as a model.

Yes, as a proxy as you know they're there.

Similarities.

With the <unk> story, and our story under distinct similarities.

As an example of what can be done in a highly concentrated as youre well aware.

Market space were really two players and Fresenius and Davita.

Occupy 80% of that market and provide.

Dialysis services, 80% of the patients and as you know we all are.

Already have.

Our relationship with Fresenius as part of her before Fresenius license agreement, which I think will.

Significantly to the momentum as we as we launched the drug.

Parse a bev in terms of similarity is.

Drug address in parathyroid hormone desk function 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.

The similarity of course is there'll be an 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 <unk>.

<unk> that could substitute there so that's a desk similarity.

So that may see additional momentum we think.

And the launch.

In terms of the group, we're working with Chris has already emphasized that we see.

The <unk> team and thank 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.

For team launched Mircera, a number of years ago, and really saw a very significant uptick there which was somewhat similar to that achieved parse it before so we know they have the.

Mechanisms and relationships that can really move product into that space. So 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 <unk>.

From that.

Let's start with Parenthetically MP trials are you going to be per screen.

All the way through development phase III, just squeezing it implementation.

For possible you know used off label uses a broad antipruritic drug how should we think about those two indications.

Yeah. So the present plant Annabel is our two primary phase III registration programs will be in atopic derm and non dialysis dependent <unk> patients, that's where we're committed to pushing forward and getting those programs underway as soon as we can next year.

The data were looking for and chronic liver disease patients and Natasha Pyrostat AK is really to <unk>.

Satisfy this idea that the.

Some of cursive.

Is broadly applicable and it's applicable regardless of the initiating pathophysiology that engendered the moderate to severe pruritus and so our aim is to.

<unk> produced data across each of these major pathophysiological categories and that includes neuropathic pruritus with N P and systemic pruritus and organ disease pruritus with C. L data would be supportive of the idea that ultimately.

Christy over injection, sorry oral Chris.

<unk> is a drug.

We're a broader label would be would be more appropriate if we can see efficacy across all of these various.

Patient population. So presently we don't have a plan to push forward with registration programs in either C. L.

Our neuropathic edge.

Great. Thank you.

Thanks Annabel.

Next question is from Joseph Stringer of Needham and company. Your line is now open.

Hi, This is been required on per Joey just one question for Mike. Thank you for taking it and by the way.

So this is for Chris based on prior commercial experience what are some things.

It's hard to be doing to maximize profitability on a good question.

Yes. Thanks for the question I mean, we're gonna be highly highly engaged with the Florida 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 is going to be around formulary and protocol placement of the dialysis organizations and then promotional logs launch execute.

<unk>.

We're going to be highly focus would be for those three priorities.

As we think about some of the kind of leading Kpis key performance indicators will go to monitor.

Gonna be riding along with those we're going to really look heavily at the promotional <unk> kind of the sales force reach in frequency.

It's a highly concentrated audience.

Youll roughly 4000, Nephrologist accounts and the majority of dialysis patients and <unk> is a strong strong track records of 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 the dialysis clinics that always be LDL ldls, but also the mid and smaller size.

And then obviously some of the leading indicators are all new patient starts I mean, so very patient centric drug I mean pruritus as.

As a chief concern.

The hemodialysis clinics, so we're going to really be looking at kind of the strength of adoption and we will be monitoring new patient starts.

Okay.

You're welcome.

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 carrier 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 of this accomplished over this time and for their.

Trust that they placed in me for.

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.

Okay.

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Yes.

Okay.

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All right.

[music].

Good afternoon, and welcome to Cara Therapeutics third quarter 2021 financial results Conference call.

All participants are now in a 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.

Good afternoon. This is willing Grand Lake with Stern Investor Relations and welcome to take care of Therapeutics third quarter 2021 financial results and update conference call. The news release became available just after four P. M. Today and can be found on our website at www Dot Cara Therapeutics Dot com.

You May also listen to a live webcast and replay of today's call on the investors section of the website before.

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 1095. Examples of these forward looking statements include statements concerning the company's ability to commercialize <unk> injection include.

The timing of additional regulatory submissions and approval the company's ability to maintain.

Coverage and adequate reimbursement for <unk> injection.

Performance of our commercial partners, including V for 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 companys product candidates to be Alt.

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.

Yeah.

Therapeutics undertakes no obligation to update such statements to reflect events that occur where 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 carriers, incoming President and Chief Executive Officer, and Mr. Thomas Reilly curious 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.

Terra has had a truly transfer made a transformative third quarter. This year highlighted by the FDA approval on August 23rd of <unk> 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.

<unk> 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 V for pharma.

In preparation for the launch of <unk> injection in the first half of 2022.

We are also continuing to make important progress in our oral care suite of programs and following guidance from the FDA aim to initiate phase III programs with oral <unk> 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 and carriers development with the anticipated U S commercial launch for <unk> injection.

With great momentum in our oral cursive a 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, we'll move on to the President and CEO position.

Having worked closely with Chris since he joined Cara as a board member I am 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.

Yeah, Thanks, Derrick I.

I am really thrilled to be joining such an inspiring team.

As Chief Executive Officer to lead terror into its next phase as a commercial stage biopharmaceutical company that I originally joined <unk> in 2018, as Derek said is as a board member as a director and over the past years I've worked.

Close.

With the entire team care team in this capacity that I believe in carriers mission to maximize the potential of our novel platform therapeutic pursue and fundamentally change the way that chronic intractable pruritus is treated to return quality of life to each and every patient living with variety.

This.

Now I want to take a quick moment just to express my gratitude to the board of directors, replacing 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 course Suva injection his.

Take care of our indelible and I really look forward to ensure a smooth leadership transition with this 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 there.

Great. Thank you Chris No I want to review the recent progress across each of our pipeline programs during the third quarter.

And then I will turn the call over to Tom to detail our financial results.

So starting with <unk> injection.

As we prepare for commercial launch our partner <unk> Pharma is currently embarked on a sales force driven disease State education program across the U S market in anticipation of launch next year.

In addition, <unk>.

September of this year before pharma on Cara submitted the required documentation for both to DARPA and reimbursement code to the U S centers for Medicare and Medicaid services to secure timely reimbursement and patient access to <unk> injection and enable our commercial launch.

In the first half of next year.

As a reminder, Cara executed a strategic license agreement with <unk> pharma in the fourth quarter of 2020 for the expanded commercialization of <unk> injection in all U S dialysis clinics.

That agreement features at Cara, 60% before pharma, 40% profit sharing arrangement and 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 Tresiba injection.

The company received a 50 million common stock investment at a 20% premium to the 30 day trailing average of carriers 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.

For Fresenius medical care renal pharma and Kara agreed to market <unk> injection to Fresenius Medical care North America dialysis clinics in the U S. We are approximately 40% of the U S market under our current 50% fee for pharma, 50% profit share arrangement and.

Under this agreement in October of this year, we received an additional $15 million cash paying $50 million cash payment earned based on U S regulatory approval of <unk> 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 <unk> injection for the treatment of pruritus associated with chronic kidney disease, and hemodialysis patients and the <unk> will review the.

Kishan under the centralized marketing authorization procedure under our 2018 license agreement with <unk> Fresenius will be responsible for the commercialization of <unk> injection across European territories with Cara eligible to receive tiered double digit royalty payments based on annual net sales.

And up to $440 million and tiered commercial milestones all of which are sales related.

The MAA is expected to render a decision in the second quarter of 2022.

So turning now to progress in our four or pursue a pipeline.

In Q2 of this year, we announced top line results from the care phase II dose ranging trial of oral <unk> for the treatment of moderate to severe pruritus in atopic dermatitis patients.

In this trial was a randomized double blind placebo controlled study designed to evaluate.

<unk> at the efficacy and safety of oral <unk> and 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.

Approximately 36% of patients characterized by moderate to severe atopic dermatitis and patients were randomized to three tablet strengths of oral <unk> five milligrams <unk> five milligrams and one milligram taken <unk> versus placebo for 12 weeks, followed by a four weeks of.

Active extension.

Now the cap the care results provided key information related to a defined patient group and active dose range and very importantly in effect size on the registration four point responder endpoint from which to design appropriately powered phase III trials with this data in hand, we held.

And end of Phase II meeting with the FDA in Q3 of this year and I am pleased to announce that based on guidance from that meeting we aim to initiate a phase three program with oral <unk> for the treatment of moderate to severe pruritus in a DPA should patients.

In Q1 of next year.

And we will 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 <unk> 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 five pre dialysis <unk> patients as a population for that program.

<unk> of stage for pre dialysis patients with advanced <unk> and a registration program consisting of two 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 Natasha Pyrostat acre.

<unk> to our ongoing clinical studies.

Pruritus is a very common symptom of call a static liver diseases, 20% to 30% of these patients overall experienced pruritus with that number rising to approximately 70% of patients with primary biliary cholangitis or 16 week phase II trial is designed to assess.

We now expect to report top line data from that study in the first half of 2022 due to delays in site initiations and in 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 <unk> for the treatment of moderate to severe pruritus in patients suffering from <unk> Paris Detica.

Europe Pathic disorder characterized by chronic pruritus of the upper middle back.

That phase III multicenter randomized double blind placebo controlled eight week study is designed to evaluate the efficacy and safety of oral <unk> for moderate to severe pruritus and approximately 120 subjects with Natasha Pyrostat acre randomize to receive oral Chris silver two milligrams twice daily.

Versus placebo for eight weeks, followed by a four week active extension period.

Primary efficacy endpoint is change from baseline in the weekly mean of the daily 24 hour worst itch <unk> score at week eight of treatment.

Now I am 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 a carrier during the third quarter and in recent months I believe lays the foundation for a very successful upcoming year.

With U S commercialization of <unk> injection on deck and advancement of our oral <unk> enter registration programs as well as anticipated phase two readouts next year 2022, or 2022 promises to be a catalyst rich year and 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.

Timber 32021 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.

$58 8 million, partially offset by proceeds of $1 $3 million from the exercise of stock options.

For the three months ended September 32021, net loss was $1 million or <unk> <unk> per basic and diluted share.

Compared to a net loss of $16 five or negative 35.

<unk> per basic and diluted share for the same period in 2020.

Sure.

Total revenue was $20 3 million for the three months ended September 32021.

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 32021.

Related to the regulatory milestones the company earned from before and V F.

CRP.

As the variable consideration with deemed probable upon the regulatory approval of <unk> injection in August 2021.

Of the 20 million earned.

$15 million was from the VF and CRP agreement related to the cash milestone with the regulatory approval.

And 5 million represented a 20% premium.

Within the $50 million equity milestone investment under the agreement with <unk> four.

The license.

Fees license fees revenue of $9 3 million for the three months ended September 32020 was related to license fees earned by <unk> by us in connection with the VA and 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 32021.

Compared to $21 1 million in the same period of 2020.

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 and tariffs during the third quarter in 2020.

Partially partially offset by increases in stock compensation expenses.

And payroll costs.

General and administrative expenses were $5 nine for the three months ended September 32021.

Compared to $5 2 million in the same period of 2020.

The higher G&A expenses in 2021.

Principally due to an increase in stock compensation expense consulting costs legal fees and insurance costs.

Other income net was <unk> 1 million for the three months ended September 32021, compared to <unk> 4 million in the same period of 2020 the.

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 is existing unrestricted cash and cash equivalents and available for sale marketable securities as of September 32021.

Including the milestone payments received in October 2021 of $65 million from before and VF and CRP will be sufficient to fund our currently anticipating operating expenses and capital expenditures through 2023 with.

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.

For Q&A.

Yes.

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, Thats star one to ask a question.

Or the pound key to withdraw your request.

Speakers. Our first question is from Jessica Fye of Jpmorgan. Your line is now open.

Hey, guys. Good afternoon, Thanks for taking my question.

Couple here was it always expected that you would need two pivotal phase III trials in non dialysis dependent <unk> population, how long do you think it will take those trials to enroll.

Yes, hi, Jeff 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 five dialysis.

Stage, five non dialysis dependent <unk> patients than the similarity there and their opinion was so high.

Hi to hemodialysis patients that it may be possible to conduct that program with one pivotal phase III trial.

As you know we've been interacting with the agency since at the end of Phase II meeting discussing.

Our data and epidemiological data that's published as to the similarity of stage four and stage five patients.

<unk> patients.

Our belief that that represents a viable population for the phase III program. So now that we have the sanction from the agency to expand beyond stage five.

Two the portion of stage four patients.

D C at more traditional program has been appropriate there with two pivotal phase III trials. So that's what we're planning to conduct and get that get that program underway next quarter.

And how long do you think it'll take them to enroll.

Well I never like to guide to.

So it comes as the week until we start the trials Jess So we see how the enrollment is going.

So that's what we will do once we get the trials underway and we have.

At least a quarter under our belt and look at enrollment rates, then we will guide as to when we see when we see output.

Okay.

And then how many trials will be in the atopic derm phase III program.

And lastly.

In light of all of these pivotal studies starting up how should we think about the ramp in R&D spending next year.

Yes, so the <unk> program is going to be traditional again two.

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 the various.

Strong balance sheet, we can we can certainly.

Move on all of these programs simultaneously and still see runway at this point through.

Through 2023, and that's not assuming any upcoming profit sharing income from the launch of <unk> injection or any milestones will be seen from either our U S license agreement with <unk> for our EU.

<unk> with the four so we're well positioned to run both programs.

Thank you.

Thanks, Jeff.

Next question is from Chris Howerton of Jefferies. Your line is now open.

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 for CK D 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 is in I think if I'm remembering this right Derek and apologies if I'm not was that.

Of course Hoover, even oral course Hoover is reasonably excrete it.

So if that's true how should we be thinking about.

The dosing concentration of frequency.

The less renal 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 <unk>.

Before and yourselves for the injectable course Hoover.

Could you just remind us of what the timelines are for the <unk> and the CMS coding when.

When you should hear back from those thank you.

Yes.

Chris Thanks, Thanks, Heiko to three further that's good.

So in terms of the non dialysis dependent <unk>.

<unk> patients and the numbers there.

So as I said the agency has not yet at that program.

Would be appropriate, including both stage five.

On later stage four patients who have stage four patients with advanced <unk>.

In the U S is approximately one 1 million U S patients in stage four at anytime.

<unk> majority of these will progress to advance stage for R&D stage, five or some go straight in to dialysis.

In terms of pruritus incidents across that group of patients is approximately 30% at the moderate to severe level and then stage five <unk> patients.

Only 100000 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 our addressable patient population, that's actually slightly bigger.

<unk> Chris.

Screening hole via the kidney predominantly theres no active metabolites here.

And you.

You may or may not recall, we've actually run pretty extensive PK studies in.

In non dialysis dependent <unk> patients so we know them.

What exposures, we can achieve with with appropriate dosing there and the appropriate dosing based on that PK analysis is Q is QD. So it's a once a day dosing in the <unk> patients, which contrasts with the weather.

The <unk> program of course with those patients have.

Normal kidney function and there we're looking at there.

And then.

On on making sure we're prepared for commercial launch next year, we have filed as I said in our prepared remarks, we filed both our expects our J code to DARPA applications and actually in September of this year.

We've been working very closely with CBS 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.

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.

Yes.

That's great.

Derek maybe just one very minor clarification.

<unk> stage four versus stage five are there any anticipated differences in dosing concentration or frequency.

No.

Okay.

Alright, well, thank you very much for taking the porphyry.

Thank you Chris.

Okay.

Next question is from David <unk> of Piper Sandler Your line is now open.

Thanks, So just actually had a couple of questions.

Chris.

So just looking ahead longer term at the.

At the business what are your thoughts on.

<unk>.

Potential build out of commercial infrastructure, whether it's in.

In nephrology office, earning or for atopic dermatitis.

To support to support Dermatological.

Indication just wanted to get your thoughts on are there any different than what.

What Derek and the team had said previously regarding commercial infrastructure and then no.

Secondly.

This is 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 <unk>.

<unk> product company category, if you will so.

As you think more expansively about the business do you think about other assets are you just looking at multiple indications of building out different salesforce verticals.

Just in general that's all under the umbrella of kind of where you want to take the company. Thanks.

Yeah, no. Thanks for asking those I think the first question was around the commercial.

<unk> infrastructure Buildout in the near term.

And certainly concur with the team have been on the board.

Been a part of a lot of these discussions.

First I would say is we have a great partner.

For.

That they are taking they are doing the full commercialization.

With <unk> injection.

So we're pretty excited about that and partnering with them and I think thats some of the value I could bring working on the on the launch with with not only our team at Cara, who we are.

Great.

Actual lead and then also working obviously with <unk>. So we'll be really focused on ensuring a successful launch of the course of the injection would be for I think longer term as we think about commercial infrastructure build out as something that will look as we progressed the data.

Obviously I've spent a lot of time in dermatology over the last three or four or five plus years, that's an area I know well, we would certainly think about.

<unk>.

In years to come and how we 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.

Two to look at other Adjacencies, that's always a possibility, but I kind of listen.

End of the day for me and I know for the care team I mean, we are laser focused on being the world leader in chronic pruritus, that's why I joined the board three years ago.

That's really low motivation.

And my priorities initially and building out not only the course <unk> injection launch but also.

Really building out and accelerating our clinical programs.

Okay.

Thanks, David.

Thanks, David next question is from Annabel Sammy of Stifel. Your line is now open.

Hi, guys. Thanks for taking the question.

I'm, sorry, if I missed it but when you are when you talk about the two trials.

For phase III, Karsten Ain't going to be simultaneous.

And does that also include a safety I missed if you said, it's going to require to safety and to what extent can you Paul from the IV safety database with the Chief HR.

Page four patients in there.

And then the second question I had was.

I guess, you've alluded to part of that is a good proxy.

For another green on track and I'm, just wondering what gives you that confidence that there had been any other drug launches in dialysis that seeing that kind of uptake.

Alright, alright.

Thanks.

Thanks Annabel.

So on the <unk> or the anticipated.

Oral <unk> 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 will have extensions on each of those trials that will bring us the required safety numbers, which you are familiar with or a chronic indication.

Of course, I think we will be referencing our IV data.

As part of that safety database.

We won't we won't be relying on that we will make sure we get the IC H.

Appropriate numbers from our phase III program as we design.

What was your other question.

<unk> is a module.

Yes, as appropriate as you know they're there.

Similarities.

With the <unk> story, and our story under the.

The similarities.

As an example of what can be done unless highly concentrated as you are well aware.

Market space were really two players and Fresenius and Davita.

Occupy 80% of that market and provide that.

Dialysis services to 80% of the patients and as you know we all.

Do you have.

Our relationship with Fresenius as part of our V for Fresenius license agreement, which I think will.

Significantly to the momentum as we as we launch the drug.

Partially bev in terms of similarity is.

Drug address in parathyroid hormone desk function 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.

Similarity of course is there'll be an 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 is no alternative generics or other <unk>.

<unk> that could substitute there so thats a desk similarity.

So that may see additional momentum we think.

And the launch.

In terms of the group we are working with Chris has already emphasized how we see the <unk> team and think there will be 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.

For team launched Mircera, a number of years ago, and really saw a very significant uptick there which was somewhat similar to that achieved y parse a bit. So we know they have the.

Mechanisms in relationships that can really move product into that space. So so that would be the similarity there.

And we're really looking forward to getting us to the patients as quickly as possible in the first half of next year.

Great. If I can just ask one quick follow up on the sale of the trial.

The subtle parenthetically NP trials are you going to be pursuing that.

All the way through the development phase III, just squeezing as our supplementation.

For possible.

Yes off label uses a broad antipruritic drug how should we think about those two indications.

Yes, so the present plant Annabel is our two primary phase III registration programs will be in atopic derm and non dialysis dependent <unk> patients, that's where we're committed to pushing forward and getting those programs underway as soon as we can next year.

The data were looking for and chronic liver disease patients and.

Natasha <unk> is really to satisfy this idea that the mechanism of <unk>.

Is broadly applicable and it's applicable regardless of the initiating pathophysiology that engendered the moderate to severe pruritus and so our aim is to.

<unk> produced data across each of these major pathophysiological categories and that includes neuropathic pruritus with empty and systemic pruritus or end organ disease pruritus with C. L data would be supportive of the idea that ultimately.

Chris <unk> injection and sorry, oral Chris whoever has a drug where a broader label would be would be more appropriate. If we can see efficacy across all of these various.

Patient population. So presently we don't have a plan to push forward with registration programs in either <unk> or neuropathic edge.

Great. Thank you.

Thanks Annabel.

Next question is from Joseph Stringer of Needham <unk> Company. Your line is now open.

Hi, This is been required on for Gary just one question for Myles. Thank you for taking your and by the way.

So this is for Chris based on prior commercial experience what are some things.

It's hard to be doing to maximize profitability on hydrocortisone.

Yes. Thanks for the question I mean, we're going to be highly highly engaged with the Florida as I think about kind of the priorities of this commercial launch and I'll dig in with the team.

Going to be around reimbursement, it's going to be around formulary and protocol placement of the dialysis organizations and then promotional logs launch execution.

We're going to be highly focus would be for those three priorities.

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 along with those we're going to really look heavily at the promotional <unk> kind of the sales force reach in frequency.

Highly concentrated audience.

Youll roughly 4000 Nephrologist accounts on the majority of dialysis patients and <unk> is a strong strong track record of Derek just alluded to.

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 the dialysis clinics that always be LDL ldls, but also the mid and smaller size.

And then obviously some of the leading indicators are all new patient starts so very patient centric drug.

All right as the as chief concern.

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.

Great. Thanks.

You welcome.

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.

Trust that they placed in me for.

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

Q3 2021 Cara Therapeutics Inc Earnings Call

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