Cara Therapeutics, Inc. (NASDAQ:CARA) Q3 2023 Earnings Call Transcript

And these patients with this debilitating severe itch have significant implications on their quality of life. So, listen, end of the day, if funding were available for KORSUVA injection, we think that product would have a very long runway. With oral difelikefalin, we’re really pleased. I think your other question though you asked around AD and how we prioritize AD, notalgia paresthetica and CKD, I mean, if you’re asking me what my favorite child is, I won’t say that. I think all three are incredibly valuable programs. They all have very sizable, addressable patient populations, and they all have one thing in common. There’s no available treatments. We would be the first FDA-approved treatments across these three indications. It’s a really differentiated positioning to be in.

That’s why we’re so excited about, and we’ve always been excited about the oral pipeline.

Sumant Kulkarni: And then as you go into Part A of KIND 1, what exactly do you expect to report externally? Given Part A is not powered for statistical significance, I think you use the term that it would be a ‘good proxy’ for Part B. So what would be a good outcome on Part A and what might not be a good outcome?

Chris Posner: Sure. Let me turn that to Joe.

Joana Goncalves: Hey. Thanks, Sumant. So for Part A, it’s designed really as to gather additional information for our pivotal program. So it’s not been powered to show statistical significance, but importantly it has the appropriate number of patients for us to be able to assess what the sample size needs to be and to be able to select a favorable dose for moving forward to the pivotal program. So that’s exactly what we intend to use that data for. So we’re comfortable with the patient numbers and what we can [glean from that] (ph).

Sumant Kulkarni: Thank you.

Chris Posner: Thanks, Sumant.

Operator: Thank you. Our next question comes from the line of David Amsellem of Piper Sandler.

Unidentified Analyst: Hey, thanks. This is [Tim] (ph) David. Just two from me. First, could you provide some color on the inventory burn that we should expect toward the end of the year? I know you had previously guided to depleting that built-up inventory toward the back half of the year, but given the lumpiness of quarter, we want to [get up] (ph) there. And then second and relatedly, how does this tie into your thinking around your cash flow runway? I know this was asked before, so I guess I’ll ask more directly, is monetizing or oral DFK in some way on the table? Thanks.

Chris Posner: Super. So let me address the first one around the inventory. I mean, listen, I mentioned on the call, given the rule, we’ve already seen some of the implications. I mean, one thing that happened is Fresenius is now reallocating their remaining inventory in the roughly 1,000 clinics that have not started a patient on yet and are actually reallocating that to the clinics that are. So net-net what that’s going to mean is, I mentioned the next two quarters you’re going to see further disconnection in terms of demand and sales especially at the at the Fresenius side. But I think the bigger picture there Tim is longer term given the lack of funding from CMS that we’re incredibly disappointed in that I think will have broader implications on any innovation going forward. But given the lack of funding that’s going to have significant downward pressure in both demand and sales moving forward. I think that’s a big takeaway. And on the cash runway, let me…

Ryan Maynard: Yeah. So I think to kind of answer the second part of your cash runway question first, we’ve always been very explicit that we are not going to stand up a ex-US sales force for oral difelikefalin. So yes, we are looking to continue that effort to find a partner for ex-US for oral difelikefalin. So that is a part of our plan. Obviously, it’s not included in my cash runway that I gave you.