David Amsellem: So I apologize if I missed any color here. But as you think about the cash runway and the upcoming clinical milestones, can you talk about how you’re thinking about oral DFK strategically in terms of whether this is something you’d look to monetize in some way or keep it and commercialize it. I’m just trying to get a better sense of how you’re thinking about the asset, just given the cash runway and resource constraints.
Ryan Maynard: David, this is Ryan. I’ll start out and kind of give some color on our investment in oral difelikefalin, and then I’ll pass it over to Chris to talk more about the long-term strategy for it. So the good news is that we can fully fund difelikefalin in these 3 late-stage programs, and that’s critical. And that’s what we actually are working on here at Cara. Obviously, CSL is running the launch for KORSUVA. But where we are spending our money, our investment is on these 3 programs. So in the guidance I gave you, those 3 programs, atopic dermatitis, chronic kidney disease and notalgia paresthetica are fully funded. I’ll pass it to Chris now to talk about how we think about it.
Christopher Posner: Yes, David. I mean, we still remain very focused on developing these 2 franchises. From a commercialization standpoint, we’ve been very public in saying we would certainly look and we would look for ex-U.S. partners. We do not have an intention right now of commercializing ex-U.S. And I would remind you — and I know you know this, that we own the rights to oral difelikefalin outright. So we would certainly look outside the U.S. for a partner in the U.S. Our intention is to stand up a commercial organization to maximize the potential of these products and do it alone.
David Amsellem: Okay. That’s helpful. If I may sneak in one more, this is unrelated on Europe. Just remind us what pricing for the drug is. Obviously, it varies market to market. But how should we think about pricing in Europe in the big markets, at least relative to the U.S.?
Christopher Posner: Yes. I mean — so David, you’re right. I mean, it varies market to market. What I can tell you in Germany, for example, the price per vial, I believe, is around EUR 48 per vial. So kind of 1/3 of what we have in the U.S., it’s probably a good way to think about it. I think where we’re really encouraged in Europe is the patient population. The EU5 predominantly is not that dissimilar to the U.S. And we’re seeing — Ryan alluded to it earlier, we’re seeing pretty good uptake or very good uptake actually since we launched in Germany in the fourth quarter last year in terms of both growth and patient and sales. So we’re actually really encouraged what we’re seeing. Reimbursement is very different. Again, you don’t have a TDAPA sort of system or a cliff, so to speak, on TDAPA. And CSL has got a very good commercial footprint, executing really nicely.
Operator: [Operator Instructions]. Again, that’s Our next question comes from the line of Jason Gerberry of Bank of America Securities.
Chi Fong: This is Chi on for Jason. I guess, regarding the comment about you expect to hear back from CMS on any update or change in the proposal in the final ruling sometime this Fall/Winter. Can you remind us, sort of like if you do get the — if you do or do not get the additional TDAPA. Can you help us understand, say, if you do not get the additional TDAPA, how do you think about consensus estimate doubling the sales in 2024 versus 2023? What I’m trying to get at is if the reimbursement mechanism is such that the — CMS will look at the prior year utilizations, up by 35% here, — I’m just trying to understand, do you dialysis standards just simply have to give up other treatments in order to make way for volume? I’m just trying to get a sense of sort of the disconnect between what consensus is forecasting versus the CMS proposal. And so to the extent that you can provide that color, that would be great. And then I have a follow-up after that.
Christopher Posner: Sure, Chi. I won’t comment on consensus necessarily, but I think your analysis on how this works within a capitated system is correct. If nothing’s changed, the onus is on the dialysis facilities to fund the product and actually compensate for it by looking at other avenues within that bundled rate. So what we expect and what I’d say what we’re doing is obviously working with CMS now in this comment period. And Scott mentioned earlier around voicing our concerns with the reimbursement methodology. We have some concerns around how they’re going to calculate the additional funding. But let’s be clear, there is going to be additional funding added to the bundle in their proposed rule. And when we kind of understand where CMS is going to land with that as well as the extra TDAPA period that Scott mentioned, we’ll have a better sense of the trajectory of this drug, based on the ability of dialysis facilities to resource it.
And that will be critical. And that will determine kind of the future of this drug. And again, we’re encouraged — I would say we’re confident that we have a strong case for additional TDAPA time that Scott mentioned. We’re certainly not going to handicap that at this point. I mean, we are working closely with CMS or at least providing comments to them, and we’ll engage with them during this period of time.
Chi Fong: So maybe help me understand here. So you have a 60-day comment period, and then you have this proposal coming out sometime in October, November. Is that sort of like a 2-way dialogue between you and CMS, or is it sort of more like you submit the comment, and you won’t hear about anything until October, November time frame. Just help us think about sort of the level of visibility you have between now and when the final proposal comes out?
Christopher Posner: Sure. Let me give it to Scott.
