Ryan Maynard: Yes, Joe, was that your question? Was it related to ex-U.S.? Or were you talking about the U.S. revenue stream?
Joseph Stringer: If you could comment on both, that would be helpful.
Christopher Posner: Yes. I will — let me take one off the table. On the U.S., that wasn’t our focus. We’re — from a U.S. perspective, and we get 46% of net sales essentially. And we’re really in the initial quarters of this launch. And we feel there’s pretty significant upside. Now, we’ll have to see how CMS works itself out over the next couple of months. But where our focus has been from a financing side — Ryan, maybe you could comment on the ex-U.S.
Ryan Maynard: So I think we are in a good position where we do actually have an asset that is generating cash, and this is ex-U.S. We’ve discussed in Chris’ prepared remarks how well Europe is doing and how both CSL and ourselves are very excited about the potential for Europe going forward. So we are looking at opportunities to potentially monetize that. We also discussed the potential approval of Japan in the second half of the year. That’s also another potential cash-generating asset. So we’ve got a lot of options, and we’re hopeful that we can execute on those.
Operator: Our next question comes from the line of Sumant Kulkarni of Canaccord Genuity.
Sumant Kulkarni: I have a few here. So at what point will you or your partner have a better handle on steady-state utilization of KORSUVA IV? So you get the best possible reimbursement rates post-TDAPA. Or how long do you think you would take to get to that rate?
Christopher Posner: So Sumant, it’s a tough question because really, we’re working with 1 payer, essentially, right? CMS is the dominant payer in this ecosystem in dialysis. And understanding the funding is going to be really critical that will determine the future trajectory of this drug. And the final rule will be sometime later this year, we’re in the 60-day comment period. I think Scott summed it up nice, Sumant. I mean, we found the proposed rule, there’s some positives there, right? I mean they are adding additional funding. And that’s certainly a positive. We’re certainly moving the needle with CMS to provide access to innovation and properly fund it. But we do have some serious concerns around the reimbursement methodology that Scott very clearly outlined that would have an impact on funding and potentially could be a headwind for us.
So I would say, Sumant, it’s a little too early to talk about the trajectory until we fully understand — fully understand the CMS final rule and what that could mean from a funding standpoint long term. I mean, one thing that’s really crystal clear to us is that there is a significant unmet need. And this drug is very effective, and it actually makes a big difference in patients’ lives. So as I said before, patients at the center of everything we do. I know I can speak for my partner there in CSL Vifor with regard to KORSUVA. And our focus during this comment period is really on addressing some of these reimbursement concerns around the proposed rule that they outlined, but also, importantly, as Scott said, requesting an extension of the TDAPA period.
Because we do know TDAPA’s had — has challenged some of the uptake with some physicians is, listen, I mean, their experience is with Parsabiv. And they’re a little nervous that if they start patients on KORSUVA, they may have to stop them if funding is not available. So we’re really focused on — on this over these next, I would say, 60 days until CMS publishes their final rule.
Sumant Kulkarni: Got it. And then given the relative difficulty of figuring out an optimal utilization rate, what do you think an optimal number of years of extension of TDAPA would you be asking for? And when would you expect to get more clarity on that, given CMS is already running a process?
Christopher Posner: Sure. Let me give that to Scott to talk about our plan with the extension.
Scott Terrillion: Yes. Again, we think we have a strong argument that we should get a new TDAPA period, which is essentially 2 years. Because we need to have an amount of time where they can get the full ability to manage the utilization and get the right patient access based on what the funding is going to be. With regard to when we would hear — we expect there’s not a specific rule for how that would happen, but we would expect to hear and we would ask to hear in the November final rule, what the plan was.
Operator: [Operator Instructions]. Our next question comes from the line of David Amsellem of Piper Sandler.
