Q4 2021 Cara Therapeutics Inc Earnings Call

March 1, 2022

Good afternoon, My name is Andrew and I will be your conference facilitator.

I would like to welcome everyone to the Cara Therapeutics fourth quarter 2021 financial results and update conference call.

All lines have been placed on mute to avoid any background noise.

After the Speakers' remarks, there will be a question and answer session.

You'd like to ask a question during this time simply press star and the number one on your telephone keypad.

If you would like to withdraw your question press the pound key.

Please be advised that this call is being recorded.

I would now like to introduce Iris Francesco any interim head of Investor Relations from care Therapeutics. This Francesco you may begin your call.

Thank you Andrea and good afternoon.

Just after market close today, we issued a press release detailing our corporate progress and financial results for the fourth quarter and full year 2021.

Press release can be found on our website at Www 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.

Participating in todays call are Chris Posner, Caris, President and Chief Executive Officer, Tom Riley Caris, Chief Financial Officer, and Joanna can call. This <unk> Chief Medical Officer.

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 $19 95.

Examples of these forward looking statements include statements concerning the companys ability to successfully commercialize <unk> injection, including the timing of the product launch planned for you to regulatory submissions and potential future regulatory approvals, the company's ability to obtain and maintain coverage and adequate reimbursement for <unk> injection.

The 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.

Potential results of ongoing clinical trials timing of future regulatory and development milestones for the Companys product candidates the potential for the Companys product candidates to be alternatives in the 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 time.

Lines and plans.

Because such statements are subject to risks and uncertainties actual results may differ materially from those expressed or implied by such forward looking statements.

Risks are described more fully in Cara therapeutics filings with the Securities Exchange Commission, including the risk factors section of the company's most recent annual report on Form 10-K , and its other documents subsequently filed with or furnished to the securities and Exchange Commission.

All forward looking statements contained in today's call speak only as of the date on which they were made Cara therapeutics undertakes no obligation to update such statements to recent events that occur or circumstances stances that exist. After the date on which they were made with this I will turn it over to turn the call over to Chris. Thanks.

Cyrus and good afternoon, everyone with me today are Tom Reilly, our Chief Financial Officer, and Dr. Joe <unk>, our Chief Medical Officer.

Today I will give you a quick review of our tremendous progress delivering against our milestones commitments and plan.

Then I will provide some updates on our preparations for the launch of our first product <unk> injection.

Paul will follow with a financial update and then after that we will be available to take your questions.

I am very excited to join you today to lead my first quarterly earnings conference call as CEO of Cara Therapeutics and my first 120 days in this role I have listened and learned to make sure. We are doing the necessary things to build trust in our ability to deliver on our goals and continue growing.

I am confident that we have the ingredients to build a long term growth platform here at Cara and it starts now.

We have the right strategy in place and our work ahead is very focused on executing against our strategy.

We are building the category defining leader in pruritus. This guiding mission drives our strategy and our actions chronic pruritus is often a severe intractable problem for patients in a wide range of diseases and it is underserved by currently used treatments in light of this lack of treatment options.

Chronic pruritus remains underreported.

Even though it can have a significant negative impact on the quality of life of millions of patients.

We are committed to enhancing the awareness of this disease and improving the treatment protocols for patient care, so that our novel science benefits the most patients possible.

Over the past year, we made excellent progress executing on three strategic priorities. Our first priority is to optimize the commercial potential of course of injection.

In 2021, we had a defining moment occur in August <unk> injection became the first and only FDA approved treatment for moderate to severe pruritus in adult chronic kidney disease patients undergoing hemodialysis.

With pivotal data in more than 3200 patients our team swiftly submitted the NDA to the FDA for priority review.

Now as you will recall, we granted <unk> pharma and exclusive license to commercialize <unk> injection in the U S. V for pharma has been working diligently to prepare the market for this for this important new product.

This is a readily addressable market of 200000 U S hemodialysis patients with moderate to severe pruritus associated with chronic kidney disease.

In addition, CMS granted <unk> injection to dapper reimbursement status in December now.

I will provide more detail on the current launch preparations in a moment.

Outside the U S. We also see significant opportunities for <unk> injection, we expect the European medicines agency to make a decision on that.

Our MAA in the second quarter of this year based on the <unk> positive opinion last week.

As a reminder, and EMA approval entitles us to a $15 million cash milestone payment from our ex U S partner, the 4% is medical care renal pharma.

In Japan.

Partner <unk> Pharmaceuticals, recently announced positive phase III study results.

Our second strategic priority is to advance our all core suitable platform into phase III pruritus programs for advanced chronic kidney disease, not requiring dialysis and in atopic dermatitis.

Following end of phase II meetings with the FDA, we have a clear path forward with these two pivotal programs, we expect to initiate phase III trials in both indications. This month there will be more details on these trials at our upcoming virtual R&D day on March 11, which I hope you all can join.

Our third strategic priority is to expand the clinical utility of oral <unk> in other therapeutic areas, including <unk> and chronic liver disease.

Because of its novel mechanism of action, we see oral <unk> with the potential to be a pipeline in a product treating chronic pruritus across a broad spectrum of diseases. In 2022, we expect data readouts from phase II proof of concept studies in <unk> and then prime.

Mary Biliary cholangitis.

In both trials, we expect to see separation from placebo at the respective endpoints. These trials will provide us with critically important information to inform our path forward in these indications.

Now I'd like to provide more insight into the preparation and execution of the impending launch of <unk> injection and we are excited and we are prepared for the upcoming early April launch.

First and foremost we have the right partner <unk> pharma, who will be leading commercialization efforts together, we have a terrific partnership we have a joint steering committee that makes all key decisions concerning the launch and commercialization efforts.

Our commercial partnership with <unk> gives us a reach and frequency as well as efficiency and speed.

<unk> is a leading nephrology company with a large sales force and long standing relationships with key prescribers and dialysis organizations, particularly what are the top two fresenius with whom they have a joint venture.

The focus has been on a fast start to the launch of <unk> injection.

To achieve that the cross functional commercialization team has completed an array of prelaunch activities.

These activities will allow us to hit the ground running from the first day and hopefully steepened the launch trajectory.

Three pillars support our prelaunch work.

First the <unk> sales force is trained and engaged to prepare the market for launch before is deploying a sales force of approximately 100 Representatives. This field force has been conducted disease state education since the fourth quarter of last year for pruritus patients on hemodialysis.

Throughout the first quarter of this year. The sales team has been engaging with the entire range of health care professionals, including physicians advanced practice providers and nurses in an effort to identify prospective patients who could begin therapy quickly once <unk> injection is available.

In addition sales representatives have been trained on the package insert and they are currently using the pi and their ongoing discussions with health care providers.

All promotional campaign materials are also completed and ready to go Rob.

Representatives will be trained on these materials at live meetings in March.

Second the commercial team has made significant progress on pricing reimbursement and access on pricing, we have set a list price or WAC for consumer <unk> injection of $150 per vial or roughly 21000 per patient per year.

On reimbursement.

<unk> and the J code for <unk> injection are effective April one.

On access <unk> account team is actively engaged in formulary discussions with dialysis centers and we're really confident that <unk> injection will be on all formularies.

The consolidated nature of this market helps with this important process and the launch overall recall the top six large dialysis organizations represent about 90% of the total market.

We fully expect the product to be available at the dialysis centers.

The third pillar is preparing the supply of product to drive a robust launch we have manufactured sufficient launch quantities of course, <unk> injection and the product is already at the distribution center awaiting shipment to wholesalers in dialysis centers.

One final note on the launch.

As an anchor product, we see <unk> injection and its launch as a solid step in the validation of our mission and our strategy.

<unk> is a significantly underserved symptom across many diseases and patients want and need new treatment options positive anecdotal feedback from health care providers. In recent months is an early but important indicators that we are on the right track.

In conclusion, we are on the road to creating significant value.

In 2021, we did with many companies have not managed to do it.

<unk> and bring a novel drug through clinical development to approval as a first in class therapy.

We have also made significant progress in building our oral core Super platform.

Looking ahead, we see 2022 is a transformational year for care our focus on execution gives us confidence that we will deliver on our strategic priorities and our objectives.

First priority is to optimize the commercial potential of <unk> injection.

Through our partner <unk>, we plan to launch the first and only approved product for pruritus patients on hemodialysis, we are ready to roll for the launch with the field force pricing and reimbursement and product availability all in place.

Second we are advancing our world course suitable platform with two pivotal phase III programs for pruritus and advanced kidney disease and in atopic dermatitis.

We are in the process of initiating both programs. This month and we are excited to detailed these programs in more depth at our upcoming R&D day.

Third we are expanding the clinical utility of oral course Hoover in other therapeutic areas, including <unk> and chronic liver disease with phase II readouts to further characterize the potential of our product pipeline.

Look forward to interacting with all of you over the coming months as we build care into the leader in chronic pruritus.

Now I'd like to hand, it over to Tom Our CFO , who will go over our fourth quarter and end of year results in detail over to Utah.

Thank you Chris as a reminder, the full financial results for the fourth quarter.

And full year 2021 can be found in our press release issued today after the market closed.

For the fourth quarter of 2021, net loss was $33 4 million or <unk> 63 cents per basic and diluted share.

<unk> to a net income of $78 9 million or $1 60.

<unk> per basic and $1 59 per diluted share for the same period in 2020.

In the fourth quarter of 2021, we reported zero point $8 million of revenue compared to $112 1 million during the same period of 2020.

In Q4, 2021, we recognized zero point $7 million of commercial supply revenue related to our sales for <unk> injection to be for.

Q4, 2020, we recognized a $111 6 million.

Related to the license agreement with V for <unk> 5 million related to the license agreement with VF and CRP.

Research and development expenses were $22 8 million in the fourth quarter of 2021.

Compared to $27 1 million in the same period of 2020.

The lower R&D expenses in 2021 were principally due to a decrease in costs associated with clinical trials.

And decrease.

Creases in payroll costs.

Partially offset by $5 million in milestones earned by interest during the three months ended December 31 2021.

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

General and administrative expenses were $11 5 million in the fourth quarter of 2021 compared to two <unk> compared to $6 7 million in the same period of 2020.

The higher G&A expenses in 2021 were principally due to increases in stock based compensation expense.

Which includes $5 1 million of incremental expense related to the modification of our former CEO CEO equity awards in November of 2021.

In addition, an increase in payroll costs legal fees and insurance insurance costs.

Partially offset by decrease in consulting cost and commercial expenses.

Other income was <unk> one in the fourth quarter of 2021 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 our portfolio of investments in the 2021 period.

Now turning to the full year 2021 financial results.

Full year ended December 31, 2021, we reported a net loss of $88 4 million.

Our $1 74, or $1 74 per basic and diluted share.

<unk> to net income of $8 4 million.

<unk> 18.

Basic and diluted share for 2020.

Revenue for the year ended December 31, 2021 was $23 million as compared to $135 1 million in 2020.

In 2021, we recognized $15 million related to a license agreement with.

With V F M CRP.

$5 million from <unk> for pharma related to the premium paid by fee for pharma for the $50 million equity purchase.

We earned $1 9 million in January 2021 from <unk> related to the indication.

The initiation of the first phase III trial for Uremic, Pruritus, and <unk> 7 million of commercial supplier revenue related to our sale for <unk> injection to be for.

For the year ended 2020, we recognized $111 6 million.

Related to the license agreement with before and $22 $3 million related to license agreement with VF and CRP.

Research and development expenses were $82 7 million for the full year ended December 31 2021.

<unk> to $107 9 million for the full year ended December 31 2020.

The lower R&D expenses in 2021 were principally due to a decrease in clinical trial costs.

Partially offset by $15 million in milestones earned by interest during the year ended December 31 2021.

As compared to $5 million during the same period in 2020.

An increase in stock based compensation expense and payroll costs.

General and general and administrative expenses were $29 4 million for the full year ended December 31.

<unk> to 'twenty.

$1 8 million for the full year ended December 31 2020.

The increase in 2021 was primarily due to an increase in stock based compensation expense, which includes $5 1 million of incremental stock based compensation related to the modification of a former CEO of equity awards in November 2021.

In addition increase in payroll costs.

So fees and insurance costs, partially offset by decreased decreases in consulting costs and commercial costs.

Other income was <unk> 6 million for the full year ended December 31, 2021, compared to $2 3 million for the full year ended December 31 2020.

The decrease in 2021 was primarily due to a decrease in interest income.

<unk> from a lower yield on a lower average balance of our portfolio of investments in the 2021 period.

As of December 31, 2021, our cash cash equivalence and marketable securities totaled $236 8 million.

Compared to 251 5 million on December 31, 2020.

The decrease in the balance resulted from $60 1 million of cash used in operating activities, which was partially offset by $65 million or milestone payments received from before and VF and CRP upon the FDA approval of <unk> injection.

Of which 20 million was recognized as revenue in Q3.

Now 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, 2021 will be sufficient to fund our operations through 2023.

Not accounting for any potential product revenue or receipts of milestone payments under existing collaborations.

With that I will now turn the call back over to Chris.

Thanks, Tom.

In summary, we believe we are executing preparations that will drive significant immediate growth and helped drive growth in the years to come we have three core elements fueling our growth engine <unk> injection. We are focused on executing in the U S launch of our first product in April we and our partner <unk> are prepared course.

<unk> injection is a first of its kind product for the treatment of pruritus and chronic kidney disease patients on hemodialysis and we're ready to maximize its potential in the U S and eventually in the EU and other countries.

Second our R&D pipeline, we continue to take disciplined steps to advance our oral course suitable pipeline, which we think has the potential to be a pipeline in a product platform across the spectrum of pruritus. We are focused on turning this potential into reality, including two phase III programs start.

In this month.

And we have these strong financial foundation to drive this exciting pipeline to deliver on our growth strategy that strategy is to be the leader in bringing new treatments to the underserved patient population with pruritus in under realized market opportunity of millions of patients the law.

Each of our anchor product <unk> injection and the profitable economics of our before commercial partnership will make our foundation, even stronger to help us get there.

Now with that Tom Joe and I will be happy to take your questions. So Andrew you can now open up the call for questions.

Yes, Sir.

As a reminder, ladies and gentlemen, if you have a question. Please press Star then one on your telephone.

Our first question comes from the line of Joseph Stringer with Needham <unk> Company.

Hi, everyone. Thanks for taking our question.

Be curious to get your thoughts just from a higher level.

On la.

<unk> expectations, given your experience and.

What are some of them.

Some some comps that we could think about.

One in particular that it's somewhat of a comp would be.

Amgen's.

Yes.

Certainly some similarities there, but key differences I was wondering if you could.

Sort of compare and contrast, how you think core Suva launch could go relative to that.

That drug or any other types of comps that come to mind.

Yeah, Thanks, Joe a great here from you so.

Let me first talk about <unk>.

How I think about the upcoming launch and I'll preface that by saying, it's incredibly exciting to launch a first and only product.

And I think about this launch in a couple of different ways first it is a significant significant condition.

As I mentioned in my prepared remarks.

Total addressable population is about 200000 patients.

It is very much under reported by patients and overlook by physicians and we see a lack of significant treatments.

Again, the standards of care are typically the benadryl or the world. So as I think about kind of the overall launch dynamics, it's incredibly conducive to a strong launch.

One could think about first the overall market dynamics of reimbursement, we have reimbursement as I mentioned with to dapple.

And now we have a J code will be ready to roll in April it's a very concentrated physician audience of about 4000 nephrologist.

It's a very concentrated audience in terms of dialysis organizations will you have for <unk> and Davita accounting for roughly 80% of all the dialysis patients.

And lastly, and most important goes down to execution and we have the right partner <unk>, which is the leading <unk>.

<unk> company and they have an established sales force with strong infrastructure. So if you think about those show in terms of the drivers for success.

Two a very strong adoption.

The second part of your question was around comps and you mentioned, the Amgen product possible and we look at that as probably a good analogue during the <unk> period, but probably not a great analog after that to DAP up period. So during the <unk> period.

What we saw with <unk> is very strong uptake.

It had I believe $300 million in the first year in 2018 to $5 50.

The second year and closer to that the third year. So accumulative total of about $1 3 billion in net sales.

And we feel again that was the only product that ever got went through to that book will be the second one post to adapt.

Obviously theres a lot of differences that had competition that had a generic oral equivalent called sensitive par as well as our brand at a bar will go into the period after to depth of Joey with no competition. So again net net the fundamentals of our value proposition remains incredibly strong.

So I would conclude by saying.

The market dynamics support our very very strong launch.

And a very strong trajectory, but also sustained.

Sustained launch success, given the fact that the value proposition will be maintained with a lack of competition and the remaining unmet needs in this space.

Great. Thanks for the color very helpful and thanks for taking my question.

Thanks, Joe.

Thank you and our next question comes from the line of Chris Howerton with Jefferies.

Hi, This is <unk> on for Chris. Thank you for asking Eric for taking our questions.

What does the performance metrics for IV of course silver launch look like.

Are you expecting any pent up demand for the launch and how do you.

Anticipate COVID-19 impacting the launch and then maybe as a.

Second question I had a question is there any reason there was a lag between December and.

Decision.

<unk> implementation in April .

Okay.

Hey, Chris Let me take the last one.

So last one first in terms of the what you said the lag so we receive to DAP in December it's a 90 day implementation periods. So the CMS.

As the implementation at April one so that was via the CMS that was fully expected.

That's the last part of your question. The first part around metrics for success I believe U S.

And pent up demand the great thing.

Getting an approval last August and what we've seen was before and what we agreed to them.

For the preparation period is around strong market shaping so <unk> has been out really for the last <unk>.

Six seven months.

Doing the proper disease education awareness talking to the 4000 nephrologist that they target as well as focused on the nurses as well as dialysis organizations. So again with all with the with the proper disease awareness.

That market shaping our product shaping that's been under underway really for the last eight months, we feel it's going to be again, a very strong launch beginning in April .

Thank you.

And our next question comes from the line of Annabel, So many with Stifel.

Hi, This is Nick <unk> on for Annabel Congrats on the quarter and thanks for taking my question.

A few commercial and then maybe just a follow up if I could.

Just to drill down on the postpaid offer period.

Should we expect that.

<unk> reimbursement paradigm to cause.

On a volume inflections like likely with some level of lower pricing.

And then shifting to the EU.

Congrats on.

The positive <unk> opinion.

But what should the kind of.

Launch look like obviously before presenting answer still leading the charge for June .

Definitely a big benefit, but theres more reimbursement blocking and tackling.

When should we expect contribution to come through there.

Thanks, Nick Thanks for the question. So the first the first question is posed to adapt. So this is how we think about posted out but I mean, we think it will be in the bundle, but we think very strongly that it will be properly funded posted that but again the value proposition of <unk>.

<unk> injection will remain very strong because if you look at the competition there is no competition coming.

So we will be the first and only and that will really strength.

As we go through as more patients get on therapy. So again, we think.

Well, we're very optimistic that that posted DAP of funding will be secured the.

The second question in terms of the EU.

We think there is obviously a very large opportunity in the EU.

If we think about the patient size there is roughly 300000 patients on hemodialysis in the EU and roughly.

About the same in the U S about 40% of patients experience moderate severe pruritus depending.

Depending on the country and.

And Additionally, I think it's really important again, we talk about value proposition a lot. There are no approved products to treat CK D pruritus in hemodialysis patients in the EU.

So there may be some pricing differences clearly between the EU and the U S, but it's still a very significant opportunity.

Great and then.

Just switching to oral of course, you have a real quick.

Congrats on the stage four five expansion.

Just wondering if you can kind of give us how youre thinking about powering assumptions.

For the placebo arm now.

You know that it can be stage four and five inclusion.

Are you looking more.

The IV <unk> study and to help you think about that or more.

Great.

Study you did before with stages three to five.

Yes, Nick let me, let me turn that over to Joe Thanks, Nick.

And as you know we're going to be.

<unk> R&D day next week, and we'll be sharing more about the phase III.

And can give more details at that stage.

Okay, I guess I'll be patient thank you.

Thanks, Nick.

Thank you.

And our next question comes from the line of two months Kulkarni with Canaccord.

Good afternoon, and thanks for taking my question have a couple on the price that you can we assume very modest discounting off the 21 key missed if any and what might be a real void addressable shatter in utilization rate.

And then I have a follow up.

Hey.

Great to hear from you so on the price I mean in terms of contract and there is some contracting in the buy and bill space.

But it's certainly not as significant as you would typically see in part D. So there'll be some there'll be some contracting but it's very early to kind of assess what that would look like.

And your second question some months.

So your second question was around <unk>.

Peak share, yes, I think again, we're not at this point, we're not guiding to sales forecast.

But what I can tell you is that we're excited about the early adoption of this product and what we're hearing anecdotally.

From physicians and dialysis organizations as a real keen interest in this product I, just always reinforced the value proposition.

The significant burden of this disease and really the lack of treatment.

There are no approved treatments for pruritus.

So that's how we're kind of thinking about a very strong adoption.

<unk> for <unk> injection.

And I believe somewhat you had a second follow up.

Yes, it's more of a pipeline big thing is it frankly, it's you guys yet.

Got it got it means one of the more relatively challenging each been indications that target and given that dynamic how should we expect a read through anything you might learn from the upcoming <unk> data set and MP to your own because what pivotal programs in breakfast in atopic dermatitis for example.

Yes, let me, let me turn that to Jeff.

Thank you indeed.

Past that it is quite a challenging etch and the consequent treatment options.

Very difficult to manage.

Currently approved treatments.

And we are excited about our study and I look forward to our data readout in the second portion of this year.

Thanks.

Thank you.

Next question comes from the line of Jason <unk> with Bank of America.

Okay.

Hi.

Yeah.

Okay.

Alright.

Jason I think you are coming in and out I don't know if youre connection.

Hi, This is chi on for Jason Thanks for taking up close you can you hear me now.

I hear you perfectly yes go ahead, yes. Thank you.

For taking the questions.

So I guess first question I have is on the upcoming phase II data readout.

Can you talk about high level, the expectation, but to read out.

Yes.

Expecting looking for separation from placebo at respective duties.

So I'll be curious.

Signal seeking exercise, where youre looking for numeric separation or you're looking for.

Oh, it's for the.

Prospective phase II studies.

And I guess when I look at it.

The primary endpoint for each study.

Change from baseline.

<unk> score.

I'm curious.

Okay and can we expect any responder analysis from the top line, we saw similar to prior Rehousing Katy.

And I guess on that point would you expect ultimately to Reg.

Distributional endpoint for any of these indications.

Responder rates based on three point score.

Like.

<unk>.

Similar to the dialysis setting and I guess I would have on me.

If it is change from baseline how should investors interpret the data.

So you can extrapolate into sort of like what could be a potential registrational endpoint.

Sure sure let me.

Let me turn it to Joe and she can address those questions one by one.

Let me first address your first question regarding our expectation and BP as a proof of concept studies as a reminder, and so we are looking for numerical separation from placebo.

Additionally, you have.

Additional endpoint and we'll be looking at this data.

Hi, Ricky.

When assessing the outcome of the study.

As far as endpoints.

As you know Nick <unk> President.

Question with the agency.

And that ties to the Derm division the PBC going through the GI Division and again that will be a discussion with the Gi Division.

On the regulatory endpoints would be.

Got it.

I guess my second question is on IV pursue for <unk> company is common before.

It's up to you.

Do you have any western latest thought process on providing guidance for 2022 for IV <unk> at least the revenue contribution to the care and.

Thank you will provide any guidance in 2024.

For the year.

I'm curious.

How comfortable as management.

Consensus estimates right now I think when I look at it.

How many million, although the hotter T south don't off like the west revenue contribution and wellness products and whatnot. So.

I'll stop right there.

No no its good question.

Yes, no. It's a good question and I'll, Let me, let me turn that to Tom our CFO to talk about guidance et cetera. Thanks for the question. Please.

So right now we're not in a position to provide any sales guidance.

As Chris mentioned before.

We are confident given the product profile, the concentrated market and with our strong partner.

With our strong partnering before.

So we believe Christopher injection will have a rapid uptake.

We will continue to work with.

With before.

Upcoming quarters and at the appropriate time based on those discussions we will give guidance.

At the appropriate time.

Got it.

And I guess, just one more question from me.

The fear of a fall off.

Commentary on.

Management's thought process about that path.

We appreciate the caller I think your profile how you know.

Similarity in contrast competitive process, especially.

Especially in this setting.

Staffing.

Has that generic counterparts. So.

That concentration with a bundle.

I'm curious if I if <unk>.

After that.

I would imagine they would be classify into each category and there is already an existing in Chicago, where we where there are anti histamines such as Andrew already.

Okay.

Alright.

And I guess that means relatively low cost.

Alright.

I'm just curious how should.

Within management thinking process.

How you think about.

The differences in how Clos.

Classing paying each category growth rate and a low cost alternative.

Might factor into the bundle rate adjustments.

Right.

It's a great question so.

The post adapt as I mentioned before I mean, we.

We're incredibly optimistic that additional funding will be will.

We will be given to cover of course <unk> injection.

After to dapper expires over the next two to three years so Jason.

Again, we're very confident that it'll be there'll be funding available now. The question is why why do we why are we confident why are we optimistic you mentioned that in the pruritus category in the functional category. There is anti histamines well there is no FDA approved therapies.

For <unk>.

Provide us with hemodialysis patients there are no FDA approved therapies. So we don't believe that.

The anti Histamines will be included as they look at additional funding for <unk> injection I think that's really important again it goes down to the value proposition.

And then we also know anti Histamines have very limited efficacy in this patient population, it's really the only thing they're forum, but is certainly.

<unk> has significant limitations. So net net posted dapper I mean, we'll work with CMS they've signaled a willingness to continue to talk to us which is great.

And we will continue to talk with them, but again I think the importance for us and V for us during the <unk> period is to make sure. This drug is accessible and used by as many appropriate patients as possible.

Got it. Thanks, so much I appreciate all the color you profile. Thank you.

Thank you.

Next question comes from the line of Daniel Wally with JP Morgan.

Hey, guys. Thanks for taking my question you.

You've mentioned underreporting of pruritus by hemodialysis patients as one of the factors, including overlooking by physicians.

Trying to see if there is any plans to get to those patients. So that they are aware of treatment options, possibly through some sort of.

DTC campaigns.

Hey, Daniel Yeah, absolutely.

Having an informed and activated patient base is a critical critical lever and the commercialization plan for <unk> care apps are 100%.

As I mentioned before.

Pruritus in hemodialysis patients we've done a lot of work with V for I mean, it's underreported among patients and its undertreated why because theres no treatments.

So the marketing lever that we will pull very heavily with V for is really activating the patient base.

Okay.

And then.

So will you be responsible financially for that type of marketing or will it be before slowly.

No we won't we don't stand up any commercial organization here at at Cara, So <unk> will be responsible for the commercialization and the subsequent costs.

Okay, Great and then just to get a little bit color on the opportunity for intelligent participate you have outlined in prior presentations.

The patient opportunity tomorrow on 1 million patients of those patients how many have those have moderate to severe pruritus and this potentially addressable by treatments such as of course silver.

Yes, So let me let me tackle the first one and maybe I'll turn it to Joe for a little color commentary. So we think theres about 1 million patients that are receiving anti project medicines for four core for pruritus.

In terms of how many would be addressable by us that's work, we're still doing to be quite Frank.

I would estimate.

It's just the primary concern among these patients and what we hear is.

Daniel I think you and I spoke before we call. It it's you can't scratch and what you see is the.

The use of back Scratchers are actually of Maine.

Main treatment that folks use so we think it's a very very significant population that would be addressable.

From an oral <unk> again, we got to see how the data looks in the next quarter, but we're excited about the unmet need there and again I think Joey says there is no approved therapies in this space.

And it's a significant burden of disease on these patients.

Sure.

I think last year publication that Thats reported and that these pay.

We have about a six.

Alright.

It gives you an indication that these patients have moderate to severe <unk>.

And.

Waiting to look at that data.

Potentially.

Patient population she could save.

Who would do well with Amtrak.

Great. Thanks again for taking my question.

You guys do.

Thank you.

As a reminder to ask a question you will need to press star one on your telephone.

Our next question comes from the line of David <unk> with Piper Sandler.

Thanks, So just have a couple first on the commercial landscape for variety of course, who can you just talk about the extent to which you know.

Patients will be.

Getting say gabapentin.

Our other agents not antihistamine I should say, but other systemic.

Ahead of IV courses or how should we think about that.

And then secondly.

Then the CK b.

Study for oral <unk>.

In terms of the mix between stage four and stage five <unk> turns.

Can you just just a question for Joe.

Talk through the breakdown between the two the two buckets, how thats going to be.

How that's going to play out in the in the study and then lastly, just go through whether it's at three points or four points worse.

Rich in RF.

Endpoint and if you can't talk about it and want to wait till the R&D day, that's fine but go ahead ask your question. Thanks.

Thanks, David Great hearing from you so I'll tackle the first one in terms of the treatment algorithm.

Lung patients in hemodialysis that have moderate to severe pruritus you mentioned gabapentin.

Primary the primary treatment is.

As you know as antihistamines predominantly maybe some topical steroids, but it's predominantly antihistamines or very.

Small percentage of patients get gabapentin.

And you typically have to push the dose there and that comes with.

Some baggage around side effects.

So even in our studies <unk>, one and two we saw very few patients come in on Gabapentin very few so we think we'll get a slot in very nicely as the standard of care for these patients and that's how we view it.

In terms of your second question around CK D.

I'll turn that to Joe Thanks.

Thanks, David but we will wait for that is to give further details next week if that's the case.

A little bit patient and will.

Describe the phase III studies in more detail.

Okay figure that asks but thanks anyway.

Thanks, David.

Thank you I'm showing no further questions so with that I'll turn the call back over to President and CEO , Chris <unk> for any further remarks.

Well, thanks, a lot Andrew and thanks to everyone for joining us today to hear about our great progress heading into this year for Kara.

2022 is going to be a year of what I say focused execution.

With our partner <unk> for really leading the commercialization we are ready for an efficient successful launch of course <unk> injection.

And we are taking our pipeline to the next level. We hope you join us on March 11th for a virtual R&D event. When we we'll take a deep dive on the details of our phase III programs with Joe and some leading kols.

To say the future starts now for care, so with that I'll conclude the call and thank everyone.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating and you may now disconnect.

Yes.

[music].

Good afternoon, My name is Andrew and I will be your conference facilitator.

I'd like to welcome everyone to the Cara Therapeutics fourth quarter 2021 financial results and update conference call.

All lines have been placed on mute to avoid any background noise.

After the Speakers' remarks, there will be a question and answer session.

If you'd like to ask a question. During this time simply press star and the number one on your telephone keypad.

If you would like to withdraw your question press the pound key.

Please be advised that this call is being recorded.

I would now like to introduce Iris Francesco any interim head of Investor Relations from Cara Therapeutics Ms. Francesca Oney, you may begin your call.

Thank you Andrea and good afternoon.

Just after market close today, we issued a press release detailing our corporate progress and financial results for the fourth quarter and full year 2021.

Press release can be found on our website at Www 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.

Participating in todays call are Chris Posner, Cara's, President and Chief Executive Officer, Tom Riley Caris, Chief Financial Officer, and Joanne are Gonna call. This Carroll Chief Medical Officer.

Examples of these forward looking statements include statements concerning the company's ability to successfully commercialize cause you a injection, including the timing of the product launch planned for you to regulatory submissions and potential future regulatory approvals, the company's ability to obtain and maintain coverage and adequate reimbursement for <unk> 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.

<unk> results of ongoing clinical trials timing of future regulatory and development milestones for the Companys product candidates the potential for the company's product candidates to be alternatives in the 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 time.

Plans 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.

All forward looking statements contained in today's call speak only as of the date on which they were made Cara therapeutics undertakes no obligation to update such statements to recent events that occur or circumstances that exist. After the date on which they were made with this I will turn it over to turn the call over to Chris. Thanks.

Iris and good afternoon, everyone with me today are Tom Reilly, our Chief Financial Officer, and Dr. Joe <unk>, our Chief Medical Officer.

Today I will give you a quick review of our tremendous progress delivering against our milestones commitments and plan.

Then I will provide some updates on our preparations for the launch of our first product <unk> injection.

Tom will follow with a financial update and then after that we will be available to take your questions.

I am confident that we have the ingredients to build a long term growth platform here at Cara and it starts now.

We have the right strategy in place and our work ahead is very focused on executing against our strategy.

Chronic pruritus remains underreported.

Even though it can have a significant negative impact on the quality of life of millions of patients.

We are committed to enhancing the awareness of this disease and improving the treatment protocols for patient care, so that our novel science benefits the most patients possible.

Over the past year, we made excellent progress executing on three strategic priorities. Our first priority is to optimize the commercial potential of course <unk> injection.

With pivotal data in more than 1300 patients our team swiftly submit the NDA to the FDA for priority review.

Now as you will recall, we granted Z for pharma and exclusive license to commercialize <unk> injection in the U S. V for pharma has been working diligently to prepare the market for this for this important new product.

This is a readily addressable market of 200000 U S hemodialysis patients with moderate to severe pruritus associated with chronic kidney disease.

In addition, CMS granted <unk> injection to dapple reimbursement status in December .

I will provide more detail on the current launch preparations in a moment.

Outside the U S. We also see significant opportunities for <unk> injection, we expect the European medicines agency to make a decision on our MAA in the second quarter of this year based on the <unk> positive opinion last week.

As a reminder, and EMA approval entitles us to a $15 million cash milestone payment from our ex U S partner, the 4% is medical care renal pharma and.

In Japan.

Partner <unk> Pharmaceuticals, recently announced positive phase III study results.

Our second strategic priority is to advance our oral <unk> platform into phase III pruritus programs for advanced chronic kidney disease, not requiring dialysis and in atopic dermatitis.

Our third strategic priority is to expand the clinical utility of oral course, silver in other therapeutic areas, including <unk> and chronic liver disease.

Because of its novel mechanism of action, we see oral course, suva with the potential to be a pipeline in a product treating chronic pruritus across a broad spectrum of diseases. In 2022, we expect data readouts from phase II proof of concept studies in hotels, you pair of aesthetic and then prime.

Jerry Biliary cholangitis.

Now I'd like to provide more insight into the preparation and execution of the impending launch of <unk> injection and we are excited and we are prepared for the upcoming early April launch.

Our commercial partnership with <unk> gives us a reach and frequency as well as the efficiency and speed.

<unk> is a leading nephrology company with a large salesforce and long standing relationships with key prescribers and dialysis organizations, particularly one of the top two fresenius with whom they have a joint venture.

The focus has been on a fast start to the launch of <unk> injection.

To achieve that the cross functional commercialization team has completed an array of prelaunch activities. These activities will allow us to hit the ground running from the first day and hopefully steepened the launch trajectory.

Three pillars support our prelaunch work.

First the V for sales force is trained and engaged to prepare the market for the launch before is deploying a sales force of approximately 100 Representatives. This field force has been conducted disease state education since the fourth quarter of last year for pruritus patients on hemodialysis.

In addition sales representatives have been trained on the package insert and they are currently using the pi and their ongoing discussions with health care providers.

All promotional campaign materials are also completed and ready to go representatives will be trained on these materials at live meetings in March.

On reimbursement.

Data and the J code for <unk> injection are effective April one.

On access V. For his account team is actively engaged in formulary discussions with dialysis centers and we're really confident that core suite of injection will be on all formularies.

Consolidated nature of this market helps with this important process and the launch overall recall the top six large dialysis organizations represent about 90% of the total market.

We fully expect the product to be available at the dialysis centers.

One final note on the launch as an anchor product, we see <unk> injection and its launch as a solid step in the validation of our mission and our strategy.

This is a significantly underserved symptom across many diseases and patients want and need new treatment options positive anecdotal feedback from health care providers. In recent months is an early but important indicators that we are on the right track.

In conclusion, we are on the road to creating significant value in.

In 2021, we did with many companies have not managed to do it.

<unk> and bringing novel drug through clinical development to approval as a first in class therapy.

We have also made significant progress in building our oral core Super platform.

Looking ahead, we see 2022 is a transformational year for care our focus on execution gives us confidence that we will deliver on our strategic priorities and our objectives.

First priority is to optimize the commercial potential of course <unk> injection.

Through our partner before we plan to launch the first and only approved product for pruritus patients on hemodialysis, we are ready to roll for the launch with the field force pricing and reimbursement and product availability all in place.

Second we are advancing our oral course suitable platform with two pivotal phase III programs for pruritus and advanced kidney disease, and then they topic dermatitis.

We are in the process of initiating both programs. This month and we are excited to detail. These programs in more depth at our upcoming R&D day.

Third we are expanding the clinical utility of oral course, silver in other therapeutic areas, including <unk> and chronic liver disease with phase II readouts to further characterize the potential of our product pipeline.

I look forward to interacting with all of you over the coming months as we build care into the leader in chronic pruritus.

Now I'd like to hand, it over to Tom Our CFO , who will go over our fourth quarter and end of year results in detail over to Utah.

Thank you Chris as a reminder, the full financial results for the fourth quarter.

And full year 2021 can be found in our press release issued today after the market closed.

For the fourth quarter of 2021, net loss was $33 4 million or <unk> 63 cents per basic and diluted share comp.

Compared to a net income of $78 9 million or $1 60 per basic and $1 59 per diluted share for the same period in 2020.

In the fourth quarter of 2021, we reported zero point $8 million of revenue compared to $112 1 million during the same period of 2020.

In Q4, 2021, we recognized zero point $7 million of commercial supply revenue related talk to our sales for <unk> injection to be for.

Q4, 2020, we recognized $111 6 million.

Related to the license agreement with <unk>, four and <unk> 5 million related to the license agreement with VF and CRP.

Research and development expenses were $22 8 million in the fourth quarter of 2021.

Compared to $27 1 million in the same period of 2020.

The lower R&D expenses in 2021 were principally due to a decrease in costs associated with clinical trials and.

And decrease decreases in payroll costs.

Partially offset by $5 million in milestones earned by and tariffs during the three months ended December 31 2021.

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

General and administrative expenses were $11 5 million in the fourth quarter of 2021 compared to two compared to $6 7 million in the same period of 2020.

The higher G&A expenses in 2021 were principally due to increases in stock based compensation expense.

Which includes $5 1 million of incremental expense related to the modification of our former CEO CEO equity awards in November of 2021.

In addition, an increase in payroll costs legal fees and insurance insurance costs.

Firstly offset by decrease in consulting cost and commercial expenses.

Other income was <unk> one in the fourth quarter of 2021 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, resulting from a lower yield on our portfolio of investments in the 2021 period.

Now turning to the full year 2021 financial results.

Full year ended December 31, 2021, we reported a net loss of $88 4 million.

Our $1 74, or $1 74 per basic and diluted share.

<unk> to net income of $8 4 million for 18.

Basic and diluted share for 2020.

Revenue for the year ended December 31, 2021 was $23 million as compared to $135 1 million in 2020.

In 2021, we recognized $15 million related to a license agreement with.

With V F M CRP.

$5 million from V for pharma related to the premium paid by fee for pharma for the $50 million equity purchase.

We earned a $1 9 million in January 2021 from <unk> related to the indication.

The initiation of the first phase III trial for Uremic, Pruritus, and <unk> 7 million of commercial supplier revenue related to our sales of <unk> injection to be for.

For the year ended 2020, we recognized $111 6 million.

Related to the license agreement with V four and $22 $3 million related to a license agreement with VF and CRP.

Research and development expenses were $82 7 million for the full year ended December 31 2021.

Compared to $107 9 million for the full year ended December 31 2020.

The lower R&D expenses in 2021 were principally due to a decrease in clinical trial costs.

Partially offset by $15 million in milestones earned by interest during the year ended December 31 2021.

As compared to $5 million during the same period in 2020.

An increase in stock based compensation expense and payroll costs.

General and general and administrative expenses were $29 4 million for the full year ended December 31.

Compared to $21 8 million for the full year ended December 31 2020.

The increase in 2021 was primarily due to an increase in stock based compensation expense.

Which includes $5 $1 million of incremental stock based compensation related to the modification of a former CEO of equity awards in November 2021.

In addition increase in payroll costs.

Legal fees and insurance costs, partially offset by decreased decreases in consulting costs and commercial costs.

Other income was <unk> 6 million for the full year ended December 31, 2021, compared to $2 3 million for the full year ended December 31 2020.

The decrease in 2021 was primarily due to a decrease in interest income.

<unk> from a lower yield on a lower average balance of our portfolio of investments in the 2021 period.

As of December 31, 2021, our cash cash equivalence and marketable securities totaled $236 8 million.

Compared to 251 5 million on December 31, 2020.

The decrease in the balance resulted from $60 1 million of cash used in operating activities, which was partially offset by $65 million a milestone payments received from before and VF and CRP upon the FDA approval of <unk> injection.

Of which 20 million was recognized as revenue in Q3.

Now turning to our financial guidance.

Not accounting for any potential product revenue or receipts of milestone payments under existing collaborations.

With that I will now turn the call back over to Chris.

Thanks, Tom.

<unk> injection is a first of its current product for the treatment of pruritus and chronic kidney disease patients on hemodialysis and we are ready to maximize its potential in the U S and eventually in the EU and other countries.

In this month.

Each of our anchor product <unk> injection and the profitable economics of RV for a commercial partnership will make our foundation, even stronger to help us get there.

Now with that Tom Joe and I will be happy to take your questions. So Andrew you can now open up the call for questions.

Yes, Sir.

As a reminder, ladies and gentlemen, if you have a question. Please press Star then one on your telephone.

Our first question comes from the line of Joseph Stringer with Needham <unk> Company.

Hi, everyone. Thanks for taking our question.

Chris be curious to get your thoughts just from a higher level.

On la.

<unk> expectations, given your experience and.

You know what.

What are some of them.

Some some comps that we could think about.

One in particular that it's somewhat of a comp would be.

Amgen's.

<unk> Sir.

Certainly some similarities there, but key differences I was wondering if you could.

Sort of compare and contrast, how you think core Suva launch could go relative to that.

That drug or any other types of comps that come to mind.

Yeah. Thanks, Joe a great year from you. So let me let me first talk about.

How I think about the upcoming launch and I'll preface that by saying, it's incredibly exciting to launch a first and only product.

And I think about this launch in a couple of different ways first it is a significant significant condition.

As I mentioned in my prepared remarks that the total addressable population is about 200000 patients.

It is very much under reported by patients and overlooked by physicians and we see a lack of significant treatments.

Again, the standards of care are typically the benadryl or the world. So as I think about kind of the overall launch dynamics, it's incredibly conducive to a strong launch one could think about first the overall market dynamics of reimbursement, we have reimbursement as I mentioned with <unk>.

<unk>.

And now we have a J code will be ready to roll in April it's a very concentrated physician audience of about 4000 nephrologist.

It's a very concentrated audience in terms of dialysis organizations will you have for <unk> and Davita accounting for roughly 80% of all the dialysis patients.

And lastly, and most important goes down to execution and we have the right partner <unk>, which is the leading nephrology company and they have an established sales force with strong infrastructure. So if you think about those Joe in terms of the drivers for success.

Two a very strong adoption.

The second part of your question was around comps and you mentioned, the Amgen product possible and we look at that as probably a good analogue during the to DAP up period, but probably not a great analog after that to DAP up period. So during the <unk> period.

What we saw with positive is very strong uptake.

It had I believe $300 million in the first year in 2018 to $5 50.

The second year and closer to that the third year. So accumulative total of about $1 3 billion in net sales.

And we feel again that was the only product that ever got went through to dapper will be the second one post to adapt.

Obviously theres a lot of differences that had competition that had a generic oral equivalent called sensitive par as well as our brand at a bar will go into the period after to dapper Joey with no competition. So again net net the fundamentals of our value proposition remains incredibly strong.

So I would conclude by saying.

The market dynamics support our very very strong launch.

And a very strong trajectory, but also sustained.

Sustained launch success, given the fact that the value proposition will be maintained with a lack of competition and the remaining unmet needs in this space.

Great. Thanks for the color very helpful and thanks for taking my question.

Thanks, Joe.

Thank you and our next question comes from the line of Chris Howerton with Jefferies.

Hi, This is a combi on for Chris. Thank you for asking aircraft and taking our questions.

And what does the performance metrics for IV course, Suva launch look like.

Are you expecting any pent up demand for the launch and how do you.

Anticipate COVID-19 impacting the launch and then.

Yes.

Second question.

Is there any reason theres a lag between December and.

<unk> decision.

Okay.

Implementation in April thank.

Thank you.

Hey, Chris Let me take the last one.

So last one first in terms of the what you said the lag. So we received to dapple in December it's a 90 day implementation periods. So the CMS has the implementation at April one so that was via the CMS that was fully expected.

So that's the last part of your question. The first part around metrics for success I believe U S.

And pent up demand.

The great thing.

Getting an approval last August and what we've seen with V for and what we agreed to them.

This preparation period is around strong market shaping so V for has been out really for the last <unk>.

Six seven months doing the proper disease education awareness talking to the 4000 nephrologist that they target as well as focused on the nurses as well as dialysis organization. So.

Again with all with the with the proper disease awareness.

The market shaping our product shaping that's been under underway really for the last eight months, we feel it's going to be again, a very strong launch.

Beginning in April .

Thank you.

And our next question comes from the line of Annabel <unk> with Stifel.

Hi, This is Nick rubino on for Annabel Congrats on the quarter and thanks for taking my question.

A few commercial and then and then maybe just a follow up if I could.

So just to drill down on the posted out of a period.

Should we expect.

The bundled reimbursement paradigm to Cogs.

Volume and collections like likely with some level of lower pricing.

And then shifting to the EU.

Congrats on the.

The positive <unk> opinion.

But what should the kind of <unk>.

Launch look like obviously before presenting is decelerating the charge, which is definitely a big benefit.

But theres more reimbursement blocking and tackling kind of when should we expect contribution to come through there.

Thanks, Nick Thanks for the question. So the first the first question is posed to adapt.

So this is how we think about posted up I mean, we think it will be in the bundle, but we think very strongly that it will be properly funded posted that but again the value proposition of <unk> injection will remain very strong because if you look at the competition there is no competition.

<unk>.

So we will be the first and only and that will really strengthen.

As we go through as more patients get on therapy. So again, we think.

Well, we're very optimistic that that posted that funding will be secured.

The second question in terms of the EU.

We think there's a obviously a very large opportunity in the EU.

If we think about the patient size there is roughly 300000 patients on hemodialysis in the EU and roughly.

About the same about in the U S about 40% of patients experience moderate to severe pruritus, depending on the country.

And Additionally, I think it's really important again, we talk about value proposition a lot. There are no approved products to treat CK D. Pruritus in hemodialysis patients in the EU. So there may be some pricing differences clearly between the EU and the U S. But it's still a very significant opportunity.

Great and then.

Just switching to oral of course, we have a real quick.

Congrats on the stage four or five.

Spansion.

Just wondering if you can kind of give us how youre thinking about powering assumptions.

For the placebo arm now.

You know that it can be stage four and five inclusion.

Are you looking more.

The IV <unk> study and to help you think about that or more.

<unk>.

Study you did before with stages three to five.

Yes, Nick let me, let me turn that over to Joe Thanks, Nick.

And as you know we're going to be.

<unk> R&D day next week, and we'll be sharing a lot more with off the phase III design and can give more details at that stage.

Okay, I guess I'll be patient thank you.

Thanks, Nick.

Thank you.

Our next question comes from the line of two months' Kulkarni with Canaccord.

Good afternoon, thanks for taking our questions I have a couple on the price that you've set can we assume very modest discounting of the 'twenty. One key missed if any and what might be a real world addressable shatter in utilization rate.

And then I have a follow up.

Okay great.

Great to hear from you so on the price I mean in terms of contract and there is some contracting in the buy and bill space, but.

It's certainly not as significant as you would typically see in part D. So there'll be some there'll be some contracting but it's very early to kind of assess what that would look like.

And your second question demand so.

So your second question was around <unk>.

Peak share, yes, I think again, we're not at this point, we're not guiding to sales forecast.

But what I can tell you is that we're excited about the early adoption of this product and what we're hearing anecdotally.

Some physicians and dialysis organizations as a real keen interest in this product I, just always reinforced the value proposition.

A significant burden of this disease and really the lack of treatment.

There are no approved treatments for pruritus. So that's how we're kind of thinking about a very strong adoption.

Curve for <unk> injection.

And I believe somewhat you had a second a follow up.

Yes, Mona pipeline Big thing is it frankly, as Jeff IGF benefit because it means more relatively challenging each base indication to target and given that dynamic how should we expect a read through anything you might learn from the upcoming <unk> data set and MP to your own question, what pivotal programs and brighter than atopic dermatitis for example.

Yes, let me, let me turn that to Jeff.

Thank you indeed, nyctalgia prosthetic is quite a challenging etch and the consequent treatment options and.

Very difficult to manage.

Currently approved treatments.

We are excited about our study and look forward to our data readout in the second portion of this year.

Thanks.

Thank you.

Next question comes from the line of Jason <unk> with Bank of America.

Okay.

Hi.

Yeah.

Okay.

Alright.

Jason I think you are coming in and out I don't know if your connection.

Hi, This is chi on for Jason Thanks for taking the approach here can you hear me now.

We hear you perfectly yes go ahead, yes. Thank you.

For taking the question.

So I guess first question I have is on the upcoming phase II data readout.

Can you talk about expectations for the readout I know you guys.

Expecting looking for separation from placebo at perspective.

So I'm curious.

Signal seeking exercise, where youre looking for numeric separation.

First half results for <unk>.

With respect to phase two studies and I guess when I look at the primary endpoint for each study.

The change.

Change from baseline.

Score so I'm curious.

Okay can we expect any responder analysis from the top line, we saw similar to prior Readouts and see Katie and.

And I guess on that point would you expect ultimately the registrational endpoint for any of these indications.

Responder rates based on three point score and similar to.

<unk> and similar to the dialysis setting.

I guess I would have on me.

If it is change from baseline how should investors interpret that data.

You can extrapolate into sort of like what could be a potential registrational endpoint.

Sure sure let me check.

Let me turn it to Joe and she can address those questions. One by one so let me first address your first question regarding our expectation in the proof of concept studies as a reminder, and so we are looking for numerical separation from placebo.

Additionally, you have either.

There is no endpoint and we'll be looking at the data in its entirety.

When assessing the outcome of the study.

As far as regulatory endpoint.

As you know Nick <unk> President since this will be a discussion with the agency.

And that ties to the Derm division the PBC going through the GI Division and again that will be a discussion with the Gi Division.

Yes.

But the regulatory endpoints would be.

Got it.

I guess my second question is on IV, Christopher <unk> Company as commented before.

So if you're if you have any what's your latest thought process on providing guidance for 2022 for IV <unk> at least the revenue contribution to Kara and.

If you don't think you will provide any guidance in 2024 for.

For the year.

I'm curious how comfortable as management.

Consensus estimates right now I think when I look at it.

Is that around $70 million minus although the hearts of T cells start off Michael West revenue contribution and one is product sales and whatnot. So.

I'll stop right there.

No no good question.

Yeah, Yeah, no. It's a good question I'll, Let me, let me turn that to Tom our CFO to talk about guidance et cetera. Thanks for the question Chase.

So right now we're not in a position to provide any sales guidance.

As Chris mentioned before.

We are confident given the product profile, the concentrated market and with our strong partner.

With our strong partnering before.

So we believe Chris who've injection will have a rapid uptake will continue to work with.

With before.

Upcoming quarters and at the appropriate time based on those discussions we will give guidance.

At the appropriate time.

Got it.

And I guess, just one more question from me.

The share of fall off.

Commentary on <unk>.

Management's thought process about that path.

I appreciate the color. Thank you profile, how you know.

There is a similarity in contrast competitive process.

Especially in the staffing.

In the past that generic counterparts. So.

Our asset concentration with a bundle I guess I'm curious.

First of all.

<unk>.

After this period I would imagine that would be classified and each category and there is already an existing niche category, where there are anti histamines such as manager already.

We need to go into that.

Alright.

And I guess that means relatively low cost.

It's been.

I'm just curious how should.

What's the management thinking process.

Are you thinking about the profile.

And then how it classing playing into each category growth rate and a low cost alternative how that might factor into the bundle rate adjustments.

Right.

It's a great question so.

Post adapt as I mentioned before I mean.

We're incredibly optimistic that additional funding will be.

We'll be given to cover core Suva injection.

After to dapper expires over the next two to three years. So we.

<unk> four <unk>.

Provide us with hemodialysis patients there are no FDA approved therapies. So we don't believe that.

The anti Histamines will be included as they look at additional funding for <unk> injection I think that's really important again it goes down to the value proposition.

And we also know anti Histamines have very limited efficacy in this patient population, it's really the only thing they're forum, but is certainly.

<unk> has significant limitations. So net net posted dapper I mean, we'll work with CMS they've signaled a willingness to continue to talk to us which is great.

And we will continue to talk with them, but again I think the importance for us and V for us during the stood up a period is to make sure. This drug is accessible and used by as many appropriate patients as possible.

Got it. Thanks, so much I appreciate all the color you provide thank you.

Thank you.

Next question comes from the line of Daniel <unk> with Jpmorgan.

Hi, guys. Thanks for taking my question you've.

You've mentioned underreporting of pruritus by hemodialysis patients as one of the factors, including overlooking by physicians.

Trying to see if there is any plans to get to those patients. So that they are aware of treatment options, possibly through some times some sort of.

DTC campaigns.

Hey, Daniel Yeah, absolutely.

Having an informed and activated patient base is a critical critical lever and the commercialization plan for <unk>, 100%.

As I mentioned before.

Pruritus in hemodialysis patients we've done a lot of work with V for I mean, it's underreported among patients and its undertreated why because theres no treatments.

So the marketing lever that we will pull very heavily with V for is really activating the patient base.

Okay.

And then.

So will you be responsible financially for that type of marketing or will it be before slowly.

No we won't we don't stand up any commercial organization here at Cara.

Kara So <unk> will be responsible for the commercialization and the subsequent costs.

Okay, Great and then just to get a little bit color on the opportunity for intelligent participate you have outlined in prior presentations.

The patient opportunity to bear on 1 million patients of those patients. How many have those have moderate to severe pruritus and this potentially addressable by treatment such as of course silver.

Yes, So let me let me tackle the first one and maybe I'll turn it to Joe for a little color commentary. So we think theres about 1 million patients that are receiving anti project medicines for free.

<unk> core for pruritus.

In terms of how many would be addressable by us that's work, we're still doing to be quite Frank.

I would estimate.

Which is the primary concern among these patients and what we hear is.

Daniel I think you and I spoke before we call. It the it's you can't scratch and what you see is.

The use of back Scratchers are actually of Maine.

Main treatment that folks use so we think it's a very very significant population that would be addressable.

From an oral corso, but again, we've got to see how the data looks in the next quarter, but we're excited about the unmet need there and again I think Joey says there is no approved therapies in this space.

And it's a significant burden of disease on these patients.

Sure.

I think last year publication that that's reported.

<unk> has about a six.

Alright.

It gives you an indication that these patients have moderate to severe edge.

And.

Waiting to look at that data.

Potentially.

Patient population she could save.

Who would do well with Archrock.

Great. Thanks again for taking my question.

You guys do.

Thank you.

As a reminder to ask a question you will need to press star one on your telephone.

Our next question comes from the line of David <unk> with Piper Sandler.

Thanks, So just have a couple first on the commercial landscape for driving pursue can you just talk about the extent to which.

Patients will be.

Getting say gabapentin.

Our other agents.

Antihistamine I should say, but other systemic <unk>.

Ahead of IV courses or how should we think about that.

And then secondly.

Then the CK D.

Study for oral <unk>.

In terms of the mix between stage four and stage five <unk>.

Can you just just a question for Joe just talk through the breakdown between the two the two buckets, how that's going to be.

How that's going to play out in the in the study and then lastly, just go through whether its a three point or four point, where stitch in RF.

Endpoint and if you can't talk about it and want to wait until the R&D day, that's fine, but Hey go ahead ask the question.

Thanks, David Great hearing from you so I'll tackle the first one in terms of the treatment algorithm.

Lung patients in hemodialysis that have moderate to severe pruritus you mentioned gabapentin.

Primary the primary treatment as you know as antihistamines predominantly maybe some topical steroids, but it's predominantly antihistamines are very.

Small percentage of patients get gabapentin.

And you typically have to push the dose there and that comes with.

Some baggage around side effects.

So youll even in our studies called one and two we saw very few patients come in on Gabapentin very few so we think we will get a slot in very nicely as the standard of care for these patients and that's how we view it.

In terms of your second question around CK D.

I'll turn that to Joe Thanks.

Thanks, David.

We'll wait for those to get further details next week. If that's the case I would ask you to be a little bit patient and will.

Describe the phase III studies in more detail.

Okay figure out Ed asks but thanks anyway.

Yeah.

Thanks, David.

Thank you.

<unk> no further questions so with that I'll turn the call back over to President and CEO , Chris <unk> for any further remarks.

Thanks, a lot Andrew and thanks to everyone for joining us today to hear about our great progress heading into this year for <unk> 2022 is going to be a year of what I would say focused execution.

With our partner before really leading the commercialization we are ready for an efficient successful launch of <unk> injection.

And we are taking our pipeline to the next level. We hope you join us on March 11th for a virtual R&D event, when we will take a deep dive on the details of our phase III programs with Joe and some leading kols.

I'd like to say the future starts now for care, so with that I'll conclude the call and thank everyone.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating and you may now disconnect.

Q4 2021 Cara Therapeutics Inc Earnings Call

Request a DemoDemo

TVRD

Tvardi Therapeutics

Earnings