Akebia Therapeutics, Inc. (NASDAQ:AKBA) Q3 2023 Earnings Call Transcript

And that’s — that will be — so that will be critical. We’re looking forward to that. And then on the dialysis center side, again, for the patients who are PPS patients which are — 90% of patients on dialysis are Medicare patients. Those almost used to be almost all prospective payment system, or PPS payments — patients. When Medicare Advantage was introduced into dialysis, that has moved quickly and it’s close to 40% to 50% of dialysis patients now. So, the MA area is a little more challenging since their individual contracts, each provider has a different contract, and they are a little hit and mistrial trying to understand and help ensure that there is this separate payment available for those MA patients. So, that’s more work we’ll be doing even for today.

But on those 50% of patients who are PPS patients, it’s very clear that this TDAPA designation pays for vadadustat on an ASP basis. So whenever the product is used, the dialysis center will build for the cost of vadadustat and CMS will determine ASP and reimburse at that rate. Basically, what that means is they have a fixed payment. I believe the bundled payment is $280 a dialysis session, something like that for next year and the final rule. And that includes the dollars that they would spend on ESA. So dialysis providers, they have the confidence that they’re going to get paid for vadadustat on a cost basis. and they don’t have to purchase the ESA. They look at that as an opportunity to use an innovative product and potentially a cost saving for them as well.

And that’s something that obviously is important as dialysis providers — Medicare patients are not where dialysis providers make their money. So, any opportunity they can have to squeeze those costs down, they look for that opportunity. And I think your last question was on pricing. And of course, we’re not prepared to talk about pricing for vadadustat yet. We’ve always talked about kind of understanding the market, and the market — the price in the market for ESAs has gone down pretty substantively over the last few years. Interestingly, if you look at the wholesale cost pricing of [indiscernible] or daprodustat GSK if you look at the average dose from their Phase 3 study, that would indicate about an $8,000 a year pricing. Now, we’ve indicated that the opportunity for premium pricing exists and I think that they’ve seen that as well, certainly during the TDAPA period.

So, we don’t know what their contract pricing is. We don’t have any indication that it’s going to be significantly lower than that number. So, that certainly helps inform us as we think about our pricing for the vadadustat launch.

Ed Arce: Great. Thanks John. That’s very helpful.

John Butler: Thank you, Ed. We able to get Ally back Chris?

Operator: Yes. [Operator Instructions] And again, we have Allison Bratzel of Piper Sandler. Your line is open.

John Butler: Looks like we have luckily multiple ways of communicating these things. So, Ally e-mailed Mercedes her questions. Mercedes will play Ally today.

Mercedes Carrasco: I’ll jump in. Thank you very much, Chris. And all right, let’s start with current cash burn and runway guidance. Ellen, can you talk through the runway — the cash runway guidance, especially with the loan agreement and how that might change things?

Ellen Snow: Yes. Thank you. We don’t provide OpEx guidance. But that said, Auryxia continues to contribute meaningful cash to fund operations, and we have a disciplined approach to spending and continue to streamline and become more efficient in our operations. We’re extremely happy with where we landed on our Pharmacon amendment and giving us the opportunity to invest incrementally costs to support the vadadustat launch, and we believe we have sufficient cash to fund operations well through 2024.