The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Dennis Ding - Jefferies LLC - Analyst
: Great. That's a great background. Maybe to start off, if we can focused on IV KORSUVA or KORSUVA injection. Talk about how the launch has gone
over the last 12 months. There has been some debate, some of the visibility into inventory and all that kind of stuff over the last couple of quarters.
So just talk a little bit about that and where you are.
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JUNE 08, 2023 / 7:00PM, CARA.OQ - Cara Therapeutics Inc at Jefferies Healthcare Conference
Question: Dennis Ding - Jefferies LLC - Analyst
: Got it. That's very helpful. And maybe for some of the investors in the room as well as those who are listening, maybe not entirely familiar with the
commercial infrastructure and how sales are booked and details like that. Maybe you could help clarify, if you have Cara on one end and you have
the dialysis clinics on the other end, there are different layers in between. So can you just elaborate on what those layers are and some of the
different dynamics around inventory and drawdown and things like that that could impact the launch?
Question: Dennis Ding - Jefferies LLC - Analyst
: So back in Q3, you guys put out a metric of 180,000 vials, right?
Question: Dennis Ding - Jefferies LLC - Analyst
: That was at the at the clinic level, right?
Question: Dennis Ding - Jefferies LLC - Analyst
: And the amount that you booked as revenue, that's different because those are vials that you ship to or that Vifor ships to the wholesalers, right?
Question: Dennis Ding - Jefferies LLC - Analyst
: So there is a little bit of difference there. And then ever since Q3, there's been a drawdown dynamic from the clinics as they work through that
inventory. And maybe talk about how net revenue, or collaboration revenue for you guys, have evolved since then? And importantly, what do you
think the outlook will look like in the second half of the year?
Question: Dennis Ding - Jefferies LLC - Analyst
: Right, there's no OpEx against it.
Question: Dennis Ding - Jefferies LLC - Analyst
: It goes to straight to -- sent to your royalty.
Question: Dennis Ding - Jefferies LLC - Analyst
: The trends in terms of reordering?
Question: Dennis Ding - Jefferies LLC - Analyst
: Basically like indications that the big inventory buildup in Q3 is slowly being depleted, right?
Question: Dennis Ding - Jefferies LLC - Analyst
: Okay.
Question: Dennis Ding - Jefferies LLC - Analyst
: Right. And in Q1, you guys just reported earnings about a month ago or a few weeks ago, you guys reported 40,000 -- around 45,000 vials shipped
again to the clinics.
Question: Dennis Ding - Jefferies LLC - Analyst
: Right?
Question: Dennis Ding - Jefferies LLC - Analyst
: And then given that we are already almost midway through June, how should we think about vials shipped in Q2? I mean, like how confident are
you that that number would grow sequentially?
Question: Dennis Ding - Jefferies LLC - Analyst
: Okay. Great. And then maybe if we take a step back around KORSUVA and how that is positioned in the market. What is standard of care there for
Question: Dennis Ding - Jefferies LLC - Analyst
: Great. And while you guys are undergoing launch, talk about how the drug is being reimbursed by now? And maybe give a little bit more detail
around TDAPA, what it is. And what is the purpose of that, especially since your TDAPA period is only two years. It's going to expire next year. So
how do we think about that dynamic?
Question: Dennis Ding - Jefferies LLC - Analyst
: In the CMS draft that was released last year, maybe talk about -- you mentioned the different options around TDAPA continuing. What is the
implication there from, in your view, from a volume perspective and a dial -- if you're in an average dialysis center. And if those rulings go into effect
and finalized, how would that impact demand?
Question: Dennis Ding - Jefferies LLC - Analyst
: In terms of TDAPA, you guys currently have a two-year TDAPA period. Like you said, it ends at the end of March of 2024. Is there an opportunity to
extend that for another year? And how -- like how likely do you think that would happen? And how would that impact the business?
Question: Dennis Ding - Jefferies LLC - Analyst
: Okay. And I guess essentially, what that would do is give you a little bit more time to enact some more changes in policy with CMS, given a little
bit more time to think about it. And maybe after the three years is over, maybe that new policy would be different TDAPAs that could be enacted.
Question: Dennis Ding - Jefferies LLC - Analyst
: Okay. And if we can -- we have about another five minutes, but maybe we could shift over to the pipeline. IV KORSUVA is only just one aspect of
the business. You guys have a whole pipeline as well. Maybe talk about that. Where that is? And do you have any data coming out in 2023?
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JUNE 08, 2023 / 7:00PM, CARA.OQ - Cara Therapeutics Inc at Jefferies Healthcare Conference
Question: Dennis Ding - Jefferies LLC - Analyst
: So, I think in terms of pipeline, one of the more near-term events would be atopic dermatitis. You're going to have an internal readout. Maybe talk
about the design of the trial, of the first portion. How many doses? And like you said, what you guys would see internally. You mentioned -- I mean,
like lights are going to be efficacy. How many would you disclose to the street, et cetera?
Question: Dennis Ding - Jefferies LLC - Analyst
: And to be clear, when we talk about atopic dermatitis, we're not talking about atopic dermatitis per se, like Dupixent and some of the other biologics
we've talked about. The itch component of atopic dermatitis.
Question: Dennis Ding - Jefferies LLC - Analyst
: How should we think about that placebo or -- I mean, you're comparing your drug to -- or the combination of your drug to an active comparator.
So with the steroid, naturally, it's just going to go away too. So how should we think about that harm in that -- the performance of that arm?
Question: Dennis Ding - Jefferies LLC - Analyst
: What's the typical responder rate for a topical steroid?
Question: Dennis Ding - Jefferies LLC - Analyst
: 25% to 40%, you're being used on top of that. So I mean, what would be an optimal level? Or like what's a clinically meaningful delta that you would
hope to achieve with the combo over the steroid?
Question: Dennis Ding - Jefferies LLC - Analyst
: Okay. All right. Sounds good. Well, that's all the time that we have today. Thank you, guys, for this great session, this great fireside. I hope you guys
have a great rest of the conference.
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JUNE 08, 2023 / 7:00PM, CARA.OQ - Cara Therapeutics Inc at Jefferies Healthcare Conference
Question: Dennis Ding - Jefferies LLC - Analyst
: Thank you.
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