Cara Therapeutics, Inc. (NASDAQ:CARA) Q4 2022 Earnings Call Transcript

Does that make sense?

Ryan Maynard: Yes. Oren, perfect sense. And this is Ryan again. So yes, I think the way to think about — and you’re correct on kind of the transition of the guidance from Q3 — up from Q2 to Q3 and where we are now. And I would say that the very conservative number that we have in this runway guidance, as I mentioned, is a haircut to our internal projections for KORSUVA which, as Chris mentioned, we are very positive — and positive about the full year. So I’ve kept it to the first half of 2024, but you’ve also noticed that I said at least into the first half of 2024. So, the biggest driver, and the biggest variable to this is KORSUVA profit share. And I’ve hair cut what our internal projection is. And it’s also important and we’ve talked about this before and it’s we at some point, want to give guidance along with our partners CSL Vifor, what our true expectations are for the drug, but we’re still in the first year of launch.

As we’ve said, over and over again, there’s variability and I’ve tried to stay ultra conservative in my cash runway forecasts just for that purpose. But that doesn’t — using math to back into what our expectations are, using my runway forecast is not accurate, because I did hair cut substantially from what we believed

Oren Livnat: So we can’t back into either the spend or the revenue?

Ryan Maynard: Correct.

Oren Livnat: Got you. All right. Thanks. I appreciate it.

Operator: Our next question comes from Sumant Kulkarni from Canaccord Genuity.

Sumant Kulkarni: My question is on TDAPA. What’s the specific metric used by TDAPA to calculate utilization rate? And how much visibility does Cara have on that variable on a real time basis, if at all?

Chris Posner: Hey Sumant, it’s Chris. So, we don’t — what they do is look at claims data. And again, I can just take you through what they did with parsabiv. They looked at claims data on the number of units of parsabiv and then multiplied that by their ASP. For parsabiv, they obviously added in the units for the generic and branded oral Sensipar, multiplied by their ASP and divided by the number of total dialysis treatments, and they arrived at roughly $10 a session or roughly, let’s say $700 million total for the bundle. So, we don’t have real time, neither the CSL — we don’t have real time utilization data that CMS has.

Sumant Kulkarni: So, based off of that kind of dynamic, what do you think the sweet spot would be to calculate that to arrive at a TDAPA kind of reimbursement? Would that be at some point later this year or next year? How should you think about that?

Chris Posner: Yes. So, Sumant, again, I would say — I mean, what CMS wants to look at, I mean, I’m looking at the current rule and forget — I’m going to piece off of all that work we’re doing on changing the post TDAPA mechanism, which is actually pretty encouraging. But I’ll go back to their current kind of rule is that they want to look at two years of utilization. Now, there’s one comp, and that’s parsabiv, as I mentioned before. The reason they got a third year was they said roughly that, hey, the first six months or so of a launch, given that it’s six months in arrears, it’s probably not real stable environment. Because you’re — just like our launch, right? There’s interesting dynamics you’re building, there’s some inventory, so it’s not a true reflection of utilization.