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: Joey Stringer - Needham & Company, LLC - Analyst
: Great. So the launch of IV KORSUVA last year for CKD pruritus, can you describe first the partnership with Vifor and the economics to Cara, and then
we'll kind of get into more of the launch dynamics in the next set of questions.
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APRIL 17, 2023 / 5:30PM, CARA.OQ - Cara Therapeutics Inc at Needham Healthcare Conference (Virtual)
Question: Joey Stringer - Needham & Company, LLC - Analyst
: In terms of the revenue generated to date from the drug, can you outline the revenue split between partnership with Fresenius and DaVita, the
relative contribution from that?
Question: Joey Stringer - Needham & Company, LLC - Analyst
: You mentioned, Chris, some initial differences between how Fresenius and DaVita, they market the drug, can you kind of compare and contrast
and go into a little bit more detail the similarities and differences between those two in terms of how they commercialize KORSUVA and their
expected clinics.
Question: Joey Stringer - Needham & Company, LLC - Analyst
: What's the best way to think about how that underlying demand for the drug? Is it related to say inventory levels and reorder rates?
Question: Joey Stringer - Needham & Company, LLC - Analyst
: And given the dynamics of the two LDOs that you outlined, when would you expect to see more of a steady-state demand type of launch?
Question: Joey Stringer - Needham & Company, LLC - Analyst
: What have they been hearing in terms of the persistence and compliance rates for IV KORSUVA into the launch? What are you hearing on those
two fronts?
Question: Joey Stringer - Needham & Company, LLC - Analyst
: I'm going to just take a moment to step back from the launch of just in terms of the indication itself. What is the addressable market for IV KORSUVA
when it comes to CKD pruritus patients?
Question: Joey Stringer - Needham & Company, LLC - Analyst
: And so when you think about market penetration for IV KORSUVA, number one, what types of patients are being treated initially? Is it more severe
patients in terms of age? And number two, what do you think your current market penetration is at this point in time?
Question: Joey Stringer - Needham & Company, LLC - Analyst
: And in terms of kind of expanding the market penetration into the patients that have, let's say, more moderate itch, what are the leverage that
need to be pulled? What are the things that need to be done to sort of increase the uptake in that particular patient population?
Question: Joey Stringer - Needham & Company, LLC - Analyst
: And in terms of couple of questions on reimbursement. This is a topic that a lot of investors bring up. It's a little bit complicated, but can you describe
how reimbursement works for KORSUVA? And then I have a follow-up reimbursement question.
Question: Joey Stringer - Needham & Company, LLC - Analyst
: Yeah, and it's interesting. It's sort of an evolving topic. And so you did touch on it, Chris, but just curious to get your thoughts on how would you
handicap sort of the upcoming news flow as it relates to TDAPA potential changes to TDAPA? And then how does that -- how would that impact
KORSUVA?
Question: Joey Stringer - Needham & Company, LLC - Analyst
: Very helpful discussion on the IV version of the drug KORSUVA. We also have an oral version of the drug at three late-stage programs in atopic
derm, notalgia paresthetica, and also a CKD pruritus for non-dialysis patients. But let's start with the atopic derm program. Can you just give us a
broad overview of that ongoing Phase 3 program.
Question: Joey Stringer - Needham & Company, LLC - Analyst
: Okay. That's very helpful. And also, just in terms of AD indication, it's rather largest a little bit -- there are a lot of options for patients. There are
different disease severity. You can have one of the spectrum topical cream all the way up to injectable biologics. How would you think about the
market segmentation and atopic dermatitis and how would you plan to position oral KORSUVA, what type of patients would you be targeting?
Question: Joey Stringer - Needham & Company, LLC - Analyst
: A Phase 3 program is ongoing. But in terms of the design in the Phase 3, what are the main differences between the patient populations from the
Phase 2 trial going to the Phase 3?
Question: Joey Stringer - Needham & Company, LLC - Analyst
: In terms of the data readouts for the Phase 3 program, when could we see the data? When is the next data readout for that program and what type
of data do you plan to disclose?
Question: Joey Stringer - Needham & Company, LLC - Analyst
: Okay. So those collection sample size, would you consider disclosing any more data in addition to those two things or is that something that's
under consideration or potentially up for discussion?
Question: Joey Stringer - Needham & Company, LLC - Analyst
: Okay. Great. And in terms of the Phase 3 design, this is being run -- the placebos being run, patients are using topical steroids. What are -- can you
give us a sense of what the typical placebo response rates are for those types of patients on that -- the key registrational endpoint is the four-point
responder. What are the typical placebo response rates for that?
Question: Joey Stringer - Needham & Company, LLC - Analyst
: Okay. That makes sense, and that's a very nice overview of the AD program. But I want to switch to another late-stage oral program, you're also
developing oral KORSUVA in CKD pruritus patients who are not on dialysis. Couple of questions on this one. Number one, can you provide us with
an overview of our Phase 3 program? And give us a sense of what the addressable market is for this particular indication and how that is distinct
from the IV version of the drug.
Question: Joey Stringer - Needham & Company, LLC - Analyst
: And I'll ask a similar question as it is for AD. Phase 3 program is ongoing. What are the key differences in terms of the types of patients that are
enrolled into Phase 3 relative to the Phase 2 data that you guys have put out?
Question: Joey Stringer - Needham & Company, LLC - Analyst
: Got it. And literally, excluded the stage three patients, the stage four and five. Have you disclosed the mix of those types of patients, and will these
be stratified across the arms in this trial?
Question: Joey Stringer - Needham & Company, LLC - Analyst
: Okay. That sounds very helpful. Last set of questions on the third late-stage program, notalgia paresthetica for oral KORSUVA. For those who are
not as familiar with this indication, can you describe the unmet need here and maybe outline in broad strokes your Phase 2/3 program.
Question: Joey Stringer - Needham & Company, LLC - Analyst
: Okay. In terms of the addressable patient population. You mentioned that there are no approved drugs, how would you plan to position the drug
in this particular indication?
Question: Joey Stringer - Needham & Company, LLC - Analyst
: In terms of the next readouts from the NP program, when can we expect those and what are the important efficacy end points?
Question: Joey Stringer - Needham & Company, LLC - Analyst
: And in terms of that four-point responder endpoint, what is considered clinically meaningful?
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APRIL 17, 2023 / 5:30PM, CARA.OQ - Cara Therapeutics Inc at Needham Healthcare Conference (Virtual)
Question: Joey Stringer - Needham & Company, LLC - Analyst
: Great. Very, very helpful overview in key there. Now, we talked about IV KORSUVA, the three late-stage oral programs. Just curious if you could
qualitatively rank the oral KORSUVA programs in terms of peak sales potential, how does this look and how you think this compares to the details
potential for IV KORSUVA?
Question: Joey Stringer - Needham & Company, LLC - Analyst
: And then lastly, a few quick ones on the financial related. Number one, what's your current cash position and current runway? What expectations
-- producing assumptions and expectations are built into that? And then second part would be around sort of partnerships and things of that
nature. Are you considering those?
Question: Joey Stringer - Needham & Company, LLC - Analyst
: Yeah, potential partnerships.
Question: Joey Stringer - Needham & Company, LLC - Analyst
: Well, award time for the session. Thank you so much, Chris, Joana, and Ryan, for participating. It was a great discussion. And thanks, everyone else
for joining on the webcast. Have a good day and a good rest of the conference.
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