Akebia at Canaccord Conference: Strategic Growth in Anemia Treatment

On Wednesday, 13 August 2025, Akebia Therapeutics (NASDAQ:AKBA) presented at Canaccord Genuity’s 45th Annual Growth Conference, outlining its strategic advancements and challenges. The company highlighted the successful launch of Vafcio, a treatment for anemia in dialysis patients, while also addressing the competitive landscape and future growth opportunities.

Key Takeaways

• Akebia reported a 55% increase in demand for Vafcio from Q1 to Q2, with revenues rising from $12 million to $13.3 million.
• The company plans to expand Vafcio’s prescribing access from 40,000 to 275,000 dialysis patients by November.
• Akebia aims to make Vafcio the standard of care for all chronic kidney disease (CKD) patients, both in dialysis and non-dialysis markets.
• The non-dialysis market is considered 4-5 times larger than the dialysis market, presenting significant growth potential.
• The TDAPA reimbursement period is crucial for financial incentives, allowing Vafcio to be reimbursed outside the bundle for two years.

Financial Results

• Vafcio Revenue: $12 million in Q1, increasing to $13.3 million in Q2, driven by a 55% growth in demand.
• Auryxia Revenue: $47 million in the last quarter, despite the loss of exclusivity.
• Market Size: The dialysis market is valued at a billion dollars, with Vafcio priced at $2,500 per patient post-TDAPA in the US.
• Non-Dialysis Market: Pricing ranges from $10,000 to $12,000 per patient per year.

Operational Updates

• Vafcio Launch: Initially focused on dialysis patients, with plans to expand to non-dialysis patients.
• Prescribing Access: Currently available to 40,000 dialysis patients, with expansion to 275,000 by November.
• Dialysis Providers: US Renal provides access, with IRC and DCI to follow. DaVita is initiating a pilot program.
• Studies: VOICE and VOCAL studies are examining Vafcio dosing, while a 1,500 patient non-dialysis study is planned pending FDA feedback.
• Auryxia: Despite losing exclusivity in March, no generic has been approved yet.

Future Outlook

• Vafcio Growth: Continued growth expected as access expands, aiming for standard of care status.
• NDD Trial: Awaiting FDA feedback for the non-dialysis study, with plans to start by year-end.
• Market Strategy: Targeting both dialysis and non-dialysis markets, with the latter offering a larger opportunity.

Q&A Highlights

• Anemia Management: Dialysis patients are the largest segment of the anemia market.
• Safety Profile: Vafcio shows no increased MACE risk and fewer hemoglobin excursions compared to ESAs.
• TDAPA Importance: Provides financial incentives for adopting Vafcio, covering costs outside the bundle for two years.
• Non-Dialysis Market: Significant opportunity due to lower treatment rates and limitations of ESA therapy.

Readers are encouraged to refer to the full transcript for a detailed understanding of Akebia’s strategic directions and market insights.

Full transcript - Canaccord Genuity’s 45th Annual Growth Conference:

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity and Equity Research: Hi. Good afternoon, everyone. My name is Edward Nash, senior biotechnology analyst here at Canaccord Genuity and Equity Research. I have the pleasure of being with me today, Akebia Therapeutics. From Akebia, we have John Butler who is the president and chief executive officer.

John, thank you so much for joining us.

John Butler, President and Chief Executive Officer, Akebia Therapeutics: Edward, thanks for the invitation.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity and Equity Research: And we do have Eric Ostralski, who’s the chief financial officer out in the audience. So, so hi to Eric. We call him on him if needed. That’s right. That’s right.

So, again, appreciate you guys being here. So you currently have two approved products that are on the market, but all eyes are on Vasayo, which is an oral HIF for the treatment of, anemia due to CKD in patients on dialysis. So could you talk a little bit about how the launch has gone? How basically, how what you envision for the the commercial launch, how that was gonna look. Has it really kind of panned out to what you think it was gonna look like, and any changes you think you might need to be making?

John Butler, President and Chief Executive Officer, Akebia Therapeutics: Sure. Sure. No. Thanks for the question. Yes.

Vapcio is is front and center. You’re right. All eyes are on on that, and we’re we’re actually quite happy with with how the launch is going. You know, we’re only two quarters in. You never declare victory two quarters in, but, you know, we’re really pleased.

You know, we had $12,000,000 of revenue in the first quarter, 13.3 in the second. Now the first quarter at about 8,000,000 of demand, 12,000,000 of demand in the second quarter. So we saw 55% growth all in from quarter to quarter. And importantly, when you think about this is this product is for anemia, chronic kidney disease for dialysis patients. And, you know, the interesting thing about launching in the dialysis market is you don’t just have to convince the physicians to write the product, you also have to get access from the dialysis providers.

Now there’s 550,000 dialysis patients in The US, half a million of them are on an ESA, so have a treatment for anemia. In the first two quarters, with those revenue numbers that we talked about, we really only prescribing access to about 40,000 of those dialysis patients. The third largest dialysis provider is US Renal, there are about 36,000 patients, and then a number of the smaller ones. That was the group of patients where physicians could write the product and get it. So from that perspective, we were incredibly pleased.

Now we need to expand that pool, and we’re very actively doing that. We can talk more about that I think as we go here, but we expect that the next two mid sized dialysis providers, IRC, DCI, they will have prescribing access by the end of the quarter. That adds another 30,000, patients, and then, you know, there’s two large providers, Fresenius and DaVita. Each are about 200,000 patients, and one, DaVita, is starting a pilot just in the next week to begin to allow access. So a 100 sites will be able to use the product, and then by November when the pilot’s done, it’ll be, you know, we’ll be up to 275,000 patients who have access.

So we have the real opportunity for significant step up in the growth from where we are now. So really happy with where we are, expect to be much, much happier by the end of the year.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity and Equity Research: Got it. And so if I’m not mistaken, anemia management in dialysis patients is really the biggest piece of the anemia market that you’ve alluded to. Could you maybe talk just a bit about the broader market opportunity for patients

John Butler, President and Chief Executive Officer, Akebia Therapeutics: Yeah. So you’re absolutely right. You know, the the anemia of CKD market is dominant in the dialysis population. As I said, you know, five hundred thousand out of the five hundred and fifty thousand are on on an ESA. I do wanna make sure we talk also about the nondialysis market opportunity.

It is a much smaller dollar opportunity today with the ESAs, not because the patients aren’t there, they’re not getting treated. So, you know, the opportunity there, we think, from a market opportunity and a patient impact opportunity is even broader than what you have in dialysis. But the dialysis market is clearly, one that, you know, we think again, our goal is to make Vafsio standard of care. Mhmm. You know?

So we’ll talk about, you know, here’s how physicians are thinking about it and here’s how we expect the progression of adoption to go, but our goal in our long term strategy is all around being standard of care. So, you know, we’ve got this interesting TDAPA period, this unique reimbursement period that we can talk about that creates an environment for the dialysis providers to try the product. We’ve got to pull that through with the clinical benefits of the product. We’re seeing that clearly. When you talk to physicians, Vascio is a once a day oral product versus an injectable, and so where do physicians the easiest, lowest hanging fruit for them is the home dialysis population.

That’s about fifteen percent of the dialysis population. You know, they have to come into the center more than once a month frequently to get a shot of ESA. They don’t want to come in more than once a month. They’d much rather take a pill at home, and physicians clearly identified that population. That’s mostly around convenience.

The other area where physicians are really focused on using the product is in patients who are on higher doses of ESA. As you increase your dose of ESA, you increase MACE risk. We don’t see that with Vafsio in the INNOVATE study that’s been published. Regardless of the dose of Vafsio, the MACE rate was the same. So as physicians think about where do I want to use this product first, that’s a clear area, right?

Even if they’re well controlled, they’re using a lot of the product. It’s more expensive, so I’d love to get that off my books. But also, this is a place where our patients are at risk, and with Vascio we didn’t see that. Therefore, it could be a really interesting area to start. So those are the areas where we think physicians will start to use the product, but our goal, of course, is to to go much broader than that.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity and Equity Research: Yep. That makes sense. And then so as we’ve talked about, you just you just launched in January, and so it’s still very early days, but you’re having reported two q results. Are there any specific trends that you’re currently observing with regards to launch such as metrics in in dosing or titrations? Any anything of that nature?

John Butler, President and Chief Executive Officer, Akebia Therapeutics: Yeah. I mean, certainly, mostly things that we had expected. Mhmm. Right? So, you know, with US Renal where we’re getting most of our revenue to date, know, all of what I just said about where physicians are thinking about using it hasn’t really applied.

They’ve been much more broad in where physicians have written for the product. The clinical leadership there is incredibly supportive of the difference that Vafsio can make for their patients. They really believe in pathway. Right? This is all of our positioning of the product is around this differentiated mechanism of action.

They believe in it, and so we’re seeing much broader use than just in the home or just in the high dose ESA patients, though as we talk to physicians, that’s still where they identify. So as we grow, we think that’s what’s going to happen. Now the other trend we’ve clearly seen is that the starting dose is three hundred milligrams, but in our clinical trials, it’s a titratable drug, and you’re titrating to a hemoglobin response, and the average dose in our trials, and what we’re seeing in the field, is about four thirty milligrams. It’s three hundred milligram tablet, you get titrated up to four fifty or 600. On average, we’re looking at somewhere around four thirty milligrams, which as you can see from three hundred to four fifty, that contributed a significant amount to the growth in volume that we saw from Q1 to Q2, we definitely continue to expect that to grow.

Now as you add new patients, that dose average dose may drop because we’re adding new patients as we get to that bigger pool of patients that we can treat. But as you have more and more patients on, that average dose, should be, near, what we saw in the clinical trials, or maybe a little bit higher. Usually in real life, you see doses that are a little bit higher than a clinical trial. Yep.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity and Equity Research: And then can you talk a little bit about the about the safety profile, that you’ve seen seen to date, for for the drug, and just kind of how that’s that compares to equal usage? Yeah.

John Butler, President and Chief Executive Officer, Akebia Therapeutics: So so the INNOVATE trial, the phase three trial that we did that supported the approval of the product, was a non inferiority trial. So, basically, the bar that we had was that we had to prove, and it was a MACE endpoint, major adverse cardiovascular events. So we clearly demonstrated that there was no increased MACE risk with Vafcio. Hazard ratio was point nine one, upper bound at 1.11, and we were trying to rule out 1.25. So it was clearly a strong result.

You really start coming down to the differentiation around safety comes down to the things you saw in the trial. Physicians worry about having excursions of hemoglobin. Their target level is 10 to 11, is the target hemoglobin level. But frequently with ESAs you see those levels shoot beyond 11 or beyond 12, and that’s where physicians start to get concerned. One of the clear data points was that we had many fewer excursions, is what they call that, above the targeted hemoglobin range.

That matters. And what that translated to also isn’t really a safety point, this is more of a convenience point for physicians, but it’s a message that really is resonating. With ESAs, to avoid those excursions, they’re constantly tweaking the dose of ESAs to keep people within the range. Well, what we saw in our phase three trial was that you had half the number of dose titrations with Vafsio that you had with an ESA. In other words, because we have this more physiologic, more gradual increase in hemoglobin, you still have to titrate patients get them in the range, but then they stay there, and it’s amazing the impact of a message that speaks to a busy nephrologist that they don’t have to spend a lot of time titrating patients.

And remember, it’s a convenience thing, but why are they doing that titration? Because they’re concerned about safety.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity and Equity Research: So if you are seeing fewer excursions, with Vaseo, so does that actually translate into the patient perhaps not needing to come in as often, or they’re still coming in because that’s typical for these patients for their normal lab work?

John Butler, President and Chief Executive Officer, Akebia Therapeutics: Yeah. So remember, you have two different sets of patients. You have patients who are in center, which are 80 percent, and then the home patient. Home patients, the the main reason they have to come they all have to come in once a for their regular kind of checkup, if you will, but I was speaking to a nephrologist who’s a very large patient, home patient population on Long Island, and his group has on average the patients come in 2.3 times a month, which he goes, none of them want to come in more than once. And that’s the only reason they’re coming in is because their hemoglobin hasn’t performed, you know, hasn’t gone up the way they expect, and they need to get another shot.

So they don’t come in. You know, they they call them and say, come in. You need another, you know, dose of Merserra, whatever the drug is, and they just don’t come in. So their compliance is poor. So, you know, they look at giving them, an oral drug to take at home once a day even if they don’t take every dose, and we know patients don’t take every dose.

They’re getting better compliance than going a whole two, three, four weeks without that next shot of ESA. So that is an incredibly important thing for physicians in that home population. The patients who come into the dialysis center, it’s easier to monitor them. Now, our label has this once a day dosing. We’ve also done studies to show that you can actually deliver the drug three times a week in the dialysis center.

We did a study called Focus that showed it was very effective dosing it that way. It’s not in our label yet. We plan on talking to the FDA about that after we’ve gone through the conversations around the non dialysis population, but we have studies to support it. We have a very large post marketing study called VOICE that’s going on now in collaboration with US Renal that’s doing three times weekly dosing, and we have another one called VOCAL that we just announced that’s a three fifty patient trial that DaVita is running, we’re the sponsor, but DaVita is running the trial, that’s also looking at three times weekly dosing. So I think ultimately we’re going to get to a place where the patients who are in center, they’re gonna give them the drug, at each dialysis session and have them take it there.

Takes compliance, out of the equation completely, that observed dosing, and and maybe the better way to to deliver the drug to the patient.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity and Equity Research: Was the was the were the excursions that were or the reduction or the excursions that were seen, was there anything specifically different about those patients when we saw it, or was it just across the board?

John Butler, President and Chief Executive Officer, Akebia Therapeutics: This is across the board. Yep. You know, you really don’t you know, this is this is the idea that, you know, you give someone, know, is arynespira, Mersera, these are monthly drugs, right? You give them the shot and you’ll see their hemoglobin increase significantly. Since it’s once a month, then you’ll wait and see that come down again, and you create this hemoglobin instability, which is not what what physicians really want, but they wanna try to get that monthly lab so that it stays within that range.

It’s very hard to do, which is why they’re always tweaking.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity and Equity Research: Yep.

John Butler, President and Chief Executive Officer, Akebia Therapeutics: Right? So it’s, but it’s really just seen broadly with with patients.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity and Equity Research: So on the nondialysis side of things, that that patient opportunity, can you talk about first of all, you’d mentioned that these patients tend to just not be treated, and just what first of why is that the case, and then what kind of studies that you’ve already alluded to to a degree is that you or planned in that patient population?

John Butler, President and Chief Executive Officer, Akebia Therapeutics: Yeah. This is a really, really important opportunity, for us and for for patients. I mean, you talk to physicians who are excited about the product and want to use it in dialysis, every single one of those physicians talks about how they want to use the drug in their CKD population. It’s a once a day oral drug, you know, versus bringing someone into a hematology infusion center to give asking them to infuse it at home, which they simply won’t do and they don’t want to do buy and bill in their offices anymore. So this is an important opportunity, and, you know, that hemoglobin instability is one of the reasons they don’t treat.

So you give the way the ESA label is constructed, it’s basically a rescue therapy. So you have to wait until the hemoglobin drops below 10, which will be the case with us. Then you give them the ESA, the hemoglobin goes up, they come back in a month, If their hemoglobin is above 10, they can’t get paid for another shot, so they don’t. And so they create this hemoglobin instability and and, you know, they they first do no harm. I’m gonna wait until the hemoglobin is so low that I have to treat them.

And so, you know, we look at there was an outside research that was done. There was a chart review study that looked at stage five. Stage five CKD patients are the, have GFRs below 15. I mean, these people are really moving towards dialysis. When our non dialysis study, which didn’t meet its primary endpoint, read out in 2020, half of those patients were being treated.

In the study from this past few months, it was just over twenty percent of those patients were being treated. So, as a matter of fact, more patients are getting transfusions than are getting ESAs, different studies, but it’s a really fascinating crossing of the lines there, which in a CKD patient, as soon as you get one blood transfusion, you have a lower probability of getting a transplant because of the antibodies you could create. So this is something that patients want to stay away from. This is something, a population that’s really important to get to a product like Vafsio to be available. Now, as I mentioned, we did a study in the non dialysis population called Protect, and we missed the primary endpoint.

Now we had a it was a global study where we stratified by The US versus ex US. The US was a very clean study, everyone was treated the same way, and there was no increased MACE risk. The MACE risk really came in the ex US population for a number of reasons. FDA agreed that’s an important finding, but we missed the overall number, right, the overall endpoint. So we have to do another study, and we recognize that.

But, I mean, it is an incredibly important business opportunity because in dialysis, while we have this great opportunity during TDAPA, post TDAPA, when you enter the bundle, it’s still a billion dollar market in The U. S, but we have to drop our price significantly. You know, when we did our pricing at the beginning of the year, we really priced for the non dialysis market as well. So, you know, if you think about it from a patient perspective, it’s about the same size, about a half a 550,000 patients, but where the average price per patient post TDAPA is going to be $2,500 in The US, even taking a normal gross to net, even taking a WACC for compliance, you’re in the $10,000 to $12,000 per patient per year, four to five times the size of the dialysis market. So we think it’s an incredibly important opportunity.

It’s needed by the patients, and it’s a great opportunity for us. So, you know, we’re engaged with the FDA on the design of the study. We’ve requested a type c meeting. We’ve had a number of interactions with them this year. We’ve gotten to the point where we’ve decided on an active control, which will make pooling with our US protect data very easy.

It’s really just about getting enrollment done quickly. We think it’ll be about a 1,500 patient study, so substantive in size. We’re planning and working towards getting it started before the end of the year, so we can try to get it enrolled as quickly as we can.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity and Equity Research: Got it. So you’ve you’ve talked to you’ve mentioned now a few times, TDAPA. Can you just maybe explain the importance of that, especially as it relates to Vaseo in these first couple of years?

John Butler, President and Chief Executive Officer, Akebia Therapeutics: Yeah. Yeah. No. It’s incredibly important. Right?

TDAPA is this transitional add on payment adjustment. You have to remember, with dialysis, about eighty percent of dialysis patients are Medicare patients because even if you’re not 65, if you have dialysis, you qualify for Medicare. So TDAPA was created by CMS because they recognize in a bundled environment it’s very hard to add a new therapy. You know, how do you add a new therapy? They pay dialysis providers $274 a dialysis session to provide four hours of intense care plus ESA and IV iron and everything else.

CMS recognized that’s difficult, and they wanted the opportunity for innovative products to be used. So TDAPA pays for an innovative product outside of the bundle on an ASP basis for two years. Vafsio So and that’s why we didn’t launch until January even though we had approval last March. We had to go through the TDAPA process and, you know, got that designation as of January, and that basically pays for Vafsio on an ASP basis outside of the bundle through 2025 and 2026. So if you think it from a dialysis provider’s perspective, you know, there’s work to put a new product in.

Know, they know how to use ESAs. It is a new medicine, you know, it’s gonna be more complex. Well, they’re getting paid to do that, and they’re getting paid for that because they’re getting reimbursed today at WAC, which is about $98 per dialysis session. They’re not having to pay for ESAs, which is about on average $16 per dialysis session, but they’re still getting that full bundle payment, so they’re avoiding that cost. In our contracts with them, no one pays $98 We have an off invoice discount and a rebate based on their volume they use.

So there’s a significant economic benefit for them using Vafsio. The physicians still have to believe there’s a clinical reason to use the product, but what you want is a situation where clinicians want to use the product and the business side of dialysis says, we’re very happy for you to use that product, and that’s where of TDAPA leaves us. So, you know, those dialysis providers who are using the product today are getting a significant financial benefit. You know, they’re doing more work to earn that, but their patients are able to access the product as well. The only reason they’re willing to do that is if they know that post TDAPA, their price is gonna be what they’re paying for ESAs today because they won’t take on that that added cost.

Right? So when we did contracts with everyone, and we have contracts with all the providers, part of that was guaranteeing them that they would pay their ESA price in a post TDAPA world, and we’re very fortunate versus other potential or past TDAPA drugs that so many patients are treated for anemia and there are significant dollars in that bundle already. It creates that. As I said, $16 a dialysis session is a billion dollar market.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity and Equity Research: So that negotiation happens between you and the center with regards to, look, you know, we understand this is the price during the the TDAPA period. Correct. Once that’s up, we will stick that’s between you and the and the center. Okay. That’s correct.

So so it doesn’t really technically become part of a a bundle. If you a part of the bundle, does it? After the

John Butler, President and Chief Executive Officer, Akebia Therapeutics: After TDAP, it becomes part of the bundle. It does become. Yeah.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity and Equity Research: So

John Butler, President and Chief Executive Officer, Akebia Therapeutics: there’s no incremental payment. I mean, there’s there’s an incremental payment, too much detail to get into, but it doesn’t help us. But it is it is part of the bundle at at that point after the two years. So they know they need to treat patients for anemia. I mean, there’s a quality measure that that that they have to they have to perform, and but they don’t wanna pay a dollar more if they have an ESA.

Now we’re doing all these other studies to demonstrate the clinical differentiation for the product, and even though we know we’re gonna have to take that that lower price, we want to make that up In volume, In driving more patients appropriately onto the product and taking, you know, a very significant share of that billion dollars. I mean, our goal is and has been and will be to make Vafsio standard of care for all CKD patients, both dialysis and nondialysis. Understood.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity and Equity Research: And so you have also have, Auryxia, which is your phosphate binder. So that’s gonna go off of exclusivity very soon. Right?

John Butler, President and Chief Executive Officer, Akebia Therapeutics: It actually went off exclusivity on March 20

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity and Equity Research: of Okay. This So what how should we be thinking about that overall as it as it fits in with the

John Butler, President and Chief Executive Officer, Akebia Therapeutics: Well, Auryxia is is the gift that keeps on giving. We’re really we’re really pleased with it. Now it it as you said, it lost exclusivity on March 20. Interestingly, the phosphate binders were added to the dialysis bundle also in January, which means they have their own TDAPA, which actually has helped Auryxia, but we had an expectation that that there would be generic approvals at the March. Mhmm.

Now there is an authorized generic that, you know, is a contract that we have. We know exactly how much, that provider gets, and it’s not enough to to provide the market. So we’re at August, whatever today is, twelfth or thirteenth, and, no generic has been approved. So, you know, with $47,000,000 in revenue last quarter for, for Auryxia, We know that ultimately there will be generic approvals. Mhmm.

You know? And then we expect, you know, you have that 180 of of one and and, you know, you start to ramp. We are very conservative when we think about our, you know, cash position, etcetera, in the future about what Auryxia will bring. Mhmm. But, you know, every day that no generic is approved is is a positive day, certainly from a cash flow perspective.

We’re not putting any sales and marketing dollars against, Auryxia, so it is it is very much, you know, contributing positively to the bottom line.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity and Equity Research: How many filers have there been today?

John Butler, President and Chief Executive Officer, Akebia Therapeutics: Six. Six. Okay. Six filers, but no approvals since the March. So we don’t know why.

Yeah. But, you know, there’s a lot A

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity and Equity Research: lot of gift horse in the mouth.

John Butler, President and Chief Executive Officer, Akebia Therapeutics: Exactly. That’s exactly the way we feel about it. Look, it’s not the reason to own Akebia stuff. I mean, that is gonna you know, you gotta believe in Vafsia, which we do, but I know Eric is very happy to put that cash on the balance sheet every day.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity and Equity Research: So Well, so the time we have remaining, can you maybe just talk about some of the highlights we should be looking for over the next, say, six to twelve months.

John Butler, President and Chief Executive Officer, Akebia Therapeutics: Yeah. Well, I think that people are really hyper focused as appropriately as are we on the launch. Mhmm. Right? So, you know, they’ll be looking at our quarterly revenue.

Unfortunately, people can’t follow the prescriptions on an ongoing basis because, you know, this is bought by the dialysis provider. So we try to provide as as as much metrics as as necessary for folks to really understand that. But I think as you get to kind of early November and, you know, for our next quarterly earnings, you know, people are gonna look for that continued growth. Before that, you know, as we have other meetings and the like, getting you know, hearing from us that we’re making those strides that we said we would around IRC, DCI, the DaVita pilot, anything we may be able to get with Fresenius. All of those things continue to add the patients who can potentially access the product through physician prescribing, And then the other piece is the NDD opportunity and getting that trial started, but more importantly is, again, we’ve requested a Type C meeting, don’t have a date for that yet, but we expect that by the end, before the end of the year, we’ll be able to report back on, that meeting with the FDA.

We’re working at risk to have the study start by the end of the year. You know, if they make changes, that might leak into next, but I always say that the last patient in is more important than the first patient in, and having aligned with the FDA makes that last patient in easier. So I think people will be very focused on that. I think when you look at the stock today, I mean, people don’t really give us a lot of credit for that NDD market yet, and I think with alignment there and a clear path, you know, people can really start to think about that opportunity.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity and Equity Research: Yeah. And I think it’s really also just being in this in this TDAPA period now too as well. And, you know, it’s well well, reimbursement sometimes can seem really complicated. It it really isn’t at the end of the day. Right?

You really kinda

John Butler, President and Chief Executive Officer, Akebia Therapeutics: Oh, wait. Really It really is. But, you know, but when you understand it

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity and Equity Research: When you think of it as an you’ve got a good incentive for two years. Right? And then it just becomes part of the bundle.

John Butler, President and Chief Executive Officer, Akebia Therapeutics: That’s exactly right. But that’s, you know, but that’s what CMS wanted with this. Right? Where should the product be used? And, you know, it gives us the opportunity to get really significant penetration over the next two years.

Again, we’re not in it as a TDAPA play. Right? We’re in it for the long haul. So, you know, that’s why we’re doing voice, we’re doing vocal, we’re doing those things to continue to give us the opportunity to grow the product and become standard of care and then bring it into the nondialysis market where, you know, the opportunity is even greater.

Edward Nash, Senior Biotechnology Analyst, Canaccord Genuity and Equity Research: Yep. Fantastic. Great. Well, thank you so much for joining. I fully appreciate it.

John Butler, President and Chief Executive Officer, Akebia Therapeutics: Thank you so much for the invite

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