I think it’s in Europe, 12 years of exclusivity on market exclusivity, but that’s not a sure thing yet. But the way this contract was structured was very opportunistic for us, and we’re really quite happy with the progress our partners made.
Ed Arce: Fantastic. That’s helpful. Thank you.
John Butler: Thanks, Ed.
Operator: Thank you. One moment please for our next question. Our next question comes from the line of Julian Harrison with BTIG.
Julian Harrison: Hi, good morning. Congrats on the progress, and thank you for taking my questions. First, can you remind us of the segments of the dialysis dependent CKD market where you expect Vafseo to have the strongest use case? And with Auryxia now entering the bundle in 2025, I’m wondering if you could talk more about how maybe your long-term outlook for Auryxia revenue has changed.
John Butler: Julian, thanks so much for the question. So I’m going to ask Nick to talk about segmentation. Of course, as I said, our positioning is that this product is appropriate and labeled for any patient who’s been on dialysis at least three months. But clearly, whenever we introduce a new product, there are areas where physicians will want to use the product first, and maybe Nick can outline that.
Nicholas Grund: Yeah. And then, just to reiterate, when in talking to dialysis organizations as well as physicians, they don’t pigeonhole it to any particular modality of dialysis, whether that be in center or home. Though many, their first inclination is home patients make sense. You don’t have to bring them into the facility for additional injections. They think they’ll be well managed in the home. Many patients who are at home who unfortunately may have to stick themselves with a needle, would enjoy the ease-of-use as well as the less pain associated with an oral dosing. And so that’s a real advantage in a real population that we think will be one of the faster growing in the initial launch. The second, the size of that, that’s about 80,000 patients and so sizable.
The second patient population is the high dose ESA patients. Those are folks that are not well controlled on an ESA. They’re requiring higher and higher doses. We heard from several dialysis organization that it represents roughly 15% to 30% of their total population. And one dialysis organization went as far as said, 20% of our patients on high dose represent 50% of our ESA cost. So not only do you see a benefit in driving down high doses of ESAs that have been linked to mortality rates, you see the opportunity for economic advantages within the dialysis organizations around spending as we don’t see the same dose response needs with Vafseo. And so those two very quickly go to mind. But others have also suggested that they would love to take all of the ESA management out of the dialysis organization.
And so I do believe it’ll be a stepwise fashion. But anchoring back to what John said is the broad use in dialysis patients and becoming the next standard-of-care, which requires us to be able to address all patient needs.
John Butler: That’s one of the reasons for the desire to continue to generate more clinical data. And as we said, we plan on talking to the FDA ultimately about adding the three times weekly dosing to the label. Though, we’ve heard with the focus data that was presented last year that many dialysis providers will make that choice on their own. I am encouraged to hear about the folks who really just want to take anemia management out of the dialysis center completely, and the once-a-day oral nature of the product makes a lot of sense. Again, I’ll ask for Nick’s comments on Auryxia revenue and maybe on more specifics around the binders in the bundle. I’ll have to say, Julian, I mean, that has been our expectation. This is where we’re going to land.
I know — and there’s still the potential for legislation to delay that. But given that CMS is now put out guidance, I think it’s less and less likely that there’s going to be any delay. We’ve been readying ourselves for this for some time.
Nicholas Grund: When I think about binders in the bundle, it is one where the TDAPA profile around creating incentives around innovative products, also applies to branded products that are existing in the marketplace as they go into the bundled environment. When I think about that, I imagine dialysis organizations in our conversations, they’re going to want to put further controls around their formularies around that, and therefore, making sure we’re out there engaging with them around the value of Auryxia is extremely important. Auryxia is a very, very good binder in the eyes of the physician, and they really want to use it moving forward. I believe it’ll allow us to contract for predictability around volume in the face of potential generic competition.
We haven’t necessarily built that into our cash flow models as we talked about it, but if you can imagine folks having Auryxia on formulary with open access, certainly the Medicare fee for service patients will be that first population that we’ll see usage in. But on open formulary position with Auryxia compared to where we are today will be an enhancement to physicians access to the product and all that underpins how we think about the opportunity binders going into the bundle may present for Auryxia.
Julian Harrison: Very helpful. Thank you very much.
Operator: Thank you. Now I’m showing no further questions. So with that, I’ll hand the call back over to CEO, John Butler, for any closing remarks.
End of Q&A:
