And I think everyone could agree that sales reps can be much more effective when they’re face-to-face with people. So we expect that to be helpful as well. And a number of other — those types of dynamics. And as Ellen said, we think that the binder market has still been under pressure, but it is flattening, if you will, we think. This is obviously, we’ll continue to monitor this, but as it flattens — I mean patients still need to be treated, right? So as they come in the funnel, I think, there’s opportunity there. And we also expect competitive product to be launched in the back half of this year as well and that will come, I think, with a lot of focus on phosphate control, and that’s kind of one of those rising tide lifts all boats type moments as well.
So I think that there’s a number of those types of issues that allow us to maintain that guidance albeit I would say I would think more towards the lower end of the range where earlier in the year, I was expecting the higher end.
Ed Arce: Great. That’s very helpful. Thanks so much.
John Butler: Thank you, Ed.
Operator: Thank you. Our next question comes from Julian Harrison with BTIG. Your line is open.
Julian Harrison: Hi. Good morning. Congrats on the progress and thank you for taking my questions. First, just on the three times weekly dosing regimen, again, you studied in FO2CUS. I’m curious if you could talk more about your strategy there and how soon a potential label for vadadustat maybe be amended with this dosing regimen?
John Butler: Sure. So thanks, Julian, for the question. Welcome to the call. So three times weekly is very helpful for treating patients in the dialysis center, right? You give them the dose during your dialysis session, you ensure compliance from the patient, you don’t have to send them at home with drug. So we’ve always felt that, that was something that was important and that’s something that we could potentially add to the label that we never expected to have it in the label at launch. We will publish the data. We expect it to be presented at the ASN meeting in October from FO2CUS. FO2CUS was the large study that really looked at that three times weekly dosing. Then once we have our NDA approved in March, of course, as we’ve been talking about and expect, then we’ll have a conversation with the FDA about supplemental NDA where we’ll submit for three times weekly dosing.
Again, when you think about the low-hanging fruit for the product adoption initially, it’s home patients where daily dosing works just fine. And I would say patients who are on the highest doses of ESAs where they’re having the risk of exposure to high doses of ESAs and added cost as well to the dialysis provider. And even though those might be in-center patients, I think, they’d be willing to dose them once a day and send them home a drug or rely on the publication and choose to use three times weekly dosing. Of course, we wouldn’t be promoting three times weekly dosing until it’s in our label, but that’s certainly something that physicians can choose to do with the data that supports it. And then as I said we will start to have the three times weekly dosing regimen added to our label as quickly as we can.
Julian Harrison: Okay. Got it. Thanks. That’s helpful. And then earlier in the call, you gave a great overview on your current commercial preparations. Sorry if I missed it, but I was just curious if you’re talking at all about how much you’re manufacturing at risk ahead of potential approval of vadadustat.
John Butler: Yes. Thanks for that question, Julian. As I mentioned, the two biggest costs are people and product and product is a really significant one. Remember, we had product on the shelf ready to launch back last year. And our quality team has done a magnificent job of continuing to generate data and we’re able to push out the expiry date on that product to four years. So that product that’s on the shelf today will be able to support our launch. So we don’t have to do any incremental manufacturing and take that incremental cost to be ready to launch the drug. And of course, that drug is also going to support Medice and the European launch as well.
Julian Harrison: Excellent. Great to hear. Thanks again.
John Butler: Thanks so much, Julian.
Operator: Thank you. There are no further questions. I’d like to turn the call over to John Butler for closing remarks.
John Butler: Thanks, Michelle. We are extremely pleased with the progress we’ve made last quarter as we made significant strides towards our purpose to better the lives of people impacted by kidney disease. We’re preparing for very near-term potential catalysts. Most immediately, the resubmission of the vadadustat NDA next month. With this momentum, we believe we are now poised to disrupt the market for the anemia of CKD in dialysis patients if vadadustat is approved. Everyone at Akebia is excited to be in that position and remains motivated by our potential to help patients. The team is focused on the work we need to do in the very near future to get us there. And I look forward to continuing to update you as we move through resubmission, acceptance and ultimately, potential approval and launch of vadadustat in the US. Thank you all for joining us today.
Operator: Thank you for your participation. This does conclude the program, and you may now disconnect. Everyone have a great day. Goodbye.
