Akebia Therapeutics at H.C. Wainwright Conference: Vafseo’s Strategic Launch

On Tuesday, 20 May 2025, Akebia Therapeutics (NASDAQ:AKBA) presented at the H.C. Wainwright 3rd Annual BioConnect Investor Conference 2025, highlighting the promising launch of Vafseo for anemia in chronic kidney disease (CKD) patients on dialysis. While the launch shows strong momentum with nephrologist support, challenges remain in expanding access to non-dialysis patients. Akebia’s strategic maneuvers within the dialysis reimbursement framework are pivotal to its success.

Key Takeaways

• Akebia is actively promoting Vafseo, with significant uptake from nephrologists and dialysis organizations.
• The company is leveraging the Transitional Drug Add-on Payment Adjustment (TDAPA) to boost early adoption.
• Efforts to expand Vafseo’s use among non-dialysis CKD patients are underway, with discussions ongoing with the FDA.
• The launch strategy includes targeting both fee-for-service and Medicare Advantage patients.
• Akebia plans to lower Vafseo’s price post-TDAPA to align with current ESA pricing.

Financial Results

• Vafseo’s launch price is set at $15,500, benefiting from TDAPA for two years.
• Post-TDAPA, the price will decrease to approximately $2,500 annually, matching ESA costs.
• Medicare fee-for-service patients constitute 40-45% of the market, with 20% covered by Medicare Advantage and other plans.
• Akebia is negotiating with large dialysis organizations (LDOs) to include Medicare Advantage plans in its strategy.

Operational Updates

• By the end of Q1, 640 physicians had prescribed Vafseo, averaging 12 prescriptions each.
• US Renal Care leads in Vafseo prescriptions, with Fresenius and DaVita allowing access under specific conditions.
• A major LDO plans to pilot Vafseo at 200 sites, covering 20,000 patients, starting in Q3, with broader adoption expected in Q4.
• The pilot will test system functionalities like ordering, reimbursement, and refills.

Future Outlook

• Akebia aims to make Vafseo the standard of care for all CKD patients, including those not on dialysis.
• The non-dialysis market is equally large but potentially 4-5 times more valuable than the dialysis market due to higher pricing.
• A Type C meeting with the FDA is planned to discuss a Phase III trial for non-dialysis patients, expected to commence by year-end.
• The VOICE outcomes trial has enrolled 1,650 of 2,200 patients, with full enrollment anticipated by mid-year.

Q&A Highlights

• Akebia’s contracts cover nearly 100% of dialysis patients, with a focus on DOs due to their cost responsibility.
• TDAPA incentivizes DOs to adopt Vafseo by offering financial benefits during the initial launch.
• Post-TDAPA strategies remain complex and under discussion.

The full transcript of the conference call provides a more detailed insight into Akebia’s strategic initiatives and market positioning.

Full transcript - H.C. Wainwright 3rd Annual BioConnect Investor Conference 2025:

Matthew Caulfield, Senior Biotech Analyst, H. C. Wainwright: Right. So I guess we can get started here. So my name is Matthew Caulfield. I’m a senior biotech analyst here at H. C.

Wainwright, and we’re very excited to be welcoming Akebia Therapeutics. We’re joined by John Butler, CEO, and also Nick Grund, chief commercial officer. So thank you very much for joining us today, guys.

John Butler, CEO, Akebia Therapeutics: Thanks for having us, Matt. Great to you.

Matthew Caulfield, Senior Biotech Analyst, H. C. Wainwright: So maybe to start off, you could maybe give us an introduction to Akebia, your work in the kidney disease space and the important differentiators and opportunities that are there. Yes. Thank you. So as you said, I

John Butler, CEO, Akebia Therapeutics: mean, we are a company who is we feel very purpose driven, and our purpose is to better the lives of people who live with kidney disease. Right now, most of our focus is on the launch of our newest product, Vafsio vadadustat, which is a hypoxia inducible factor prolyl hydroxylase inhibitor to treat the anemia of chronic kidney disease for people on dialysis. It is we’re very excited about the early stages of the launch, but obviously, we think it’s a product that has significant differentiation, and we’re really excited about what it can do. Now it’s our second commercial product. We have another commercial product, Auryxia, which is a phosphate binder that maybe we’ll a little bit about and certainly has been one that’s made a difference for patients as well.

As we think about where we’re going as a company, I mean, we talk about the desire to have Vafsio become standard of care for all patients with chronic kidney disease. That means getting the launch right, doing a great launch, early days, super happy with how that’s going. But it also means that we make the product available for patients with chronic kidney disease who are not on dialysis. You know, we can talk more about that, but that is, you know, this is an oral once a day product that is a perfect way to deliver, product to patients who are not on dialysis. And and I’ll say every time I speak to a physician, about the dialysis population, where they’re excited to use the product, they are without fail, each of them says, but I really wanna use the product in the nondialysis population as well.

Mhmm. So we’re in the process of engaging with the FDA on on a path forward. We know we’re gonna to do some clinical work there, but that is part of making Vafsio standard of care for patients with chronic kidney disease. Beyond that, we don’t talk much about our pipeline, but, you know, we are building a pipeline of products within kidney disease. And then we’re also thinking about when we think about this HIF technology, we’ve really recognized that there are areas outside of the kidney where this technology can be brought to bear and we think can make a real difference for patients.

And and so building that future beyond kidney disease is kind of the third leg of the stool of how we’ll add value long term. I know today we’ll probably spend almost all of our time appropriately on the launch of Vavsio, but kind of later this year, we hope we’ll have the opportunity to spend more time talking about the pipeline as well.

Matthew Caulfield, Senior Biotech Analyst, H. C. Wainwright: Very exciting. So first quarter of this year marked the initial quarter for VAVSIO U. S. Launch in anemia CKD patients receiving dialysis. Can you discuss a little more about how that launch is progressing, the early trends you’re observing among nephrologists uptake, their enthusiasm?

John Butler, CEO, Akebia Therapeutics: Yes, we’re excited about it. Nick, why don’t you

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: Yes, we’re very pleased with what we’ve done so far in quarter one. If you look at our kind of core strategy, we really want to drive breadth of prescribing and depth of prescribing. When we think about breadth of prescribing, we think about the number of physicians that have prescribed our product. Through the end of quarter one, almost six forty physicians have prescribed the product. And then you look at depth, which is how many prescriptions on average do those prescribers write.

On average, they were they’re they’ve written about 12 prescriptions each. So getting the depth, that range ranges from people that have prescribed one prescription to some physicians who have prescribed over a hundred prescriptions. When you get to that magnitude, what you’re really seeing is adoption. You move from trial to adoption, And that’s what we want to see more broadly. And so as we look at quarter one, most of our prescriptions have been for patients that are managed by U.

S. Renal Care. But we are also seeing activation of many of the other mid and small dialysis organizations where we have protocols in place and we’re starting to see uptake.

John Butler, CEO, Akebia Therapeutics: I mean, we’re really excited about the fact that all five of the top dialysis providers who represent probably 85% of treatment have ordered the product. You know, as Dick says, U. Renal is driving the first quarter. And in the second quarter, it will be the small and medium providers, U. S.

Renal and others, who drive our revenue achievement. Remember, there’s 150,000 patients at those small and medium providers. So it’s very, very deep pool to fish from, if you will. Both Fresenius and DaVita have allowed have purchased product and are allowing access on an exception basis. So when a physician has a a patient who has a hypersensitivity to ESA or an active malignancy, those are a couple of the ones that we’ve that we’ve heard, they’ll let them write the product.

You know, that’s not where we wanna be long term from an adoption standpoint. But but it it says that they recognize there’s value here, and we just have to keep working to to expand that use. And in one of them, you know, I think we’re we’re we’re much closer. Maybe, Nick, you talk a little bit about the pilot will will be we expect to start soon.

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: One of the large dialysis organizations already have protocol in place. And so you go from contracting to protocol. Protocol then allows physicians to actually start prescribing the product. This large dialysis organizations, you got to remember these folks have a thousand clinics. And therefore, the complexity of that system is pretty intense.

So they like to pilot these things first. And so this large dialysis organization is going to pilot the product in somewhere between 5,200 clinics. 5,200 clinics is massive pilots. So 200 clinics is larger than most midsized dialysis organizations. And you look at a pilot of that size, they start off by actually training their people, which is great.

They train them on the protocol. They train them on the product. That happens for about a month of training. And then they move into usage within the trial. This is an operational pilot.

It’s not a safety, it’s not an efficacy pilot, which means what do they want to check? When someone puts it into the system, can they actually get it? Does the system allow them to decide who had the reimbursement and who doesn’t? Does it allow them to make sure that patient gets a refill on time? Those are the operational aspects of the pilot.

That pilot typically will go two to three months because they got to get a refill. So at least two months, but two to three is what we’ve been talking to them about. And then they open it up to broad usage. So we anticipate that pilot starting in quarter three and then in quarter four, opening it up to broad usage. So we’ll see additional LDO prescribers coming on in the third quarter, but really we’ll have access to that entire network starting in quarter four.

We know they’re really working towards it. Right? We have dialysis providers who’ve,

John Butler, CEO, Akebia Therapeutics: or sites who’ve raised their hand to be part of the, the trial or the pilot, and they’re being informed that they are part of the pilot. So, you know, it’s great. You always just wanna see it continuing to move towards really kicking off. And and then we’re super excited about about where that is and where the launch is in general. And I mean, it’s important too because, you know, we talked about US Renal driving, you know, the early prescribing.

Well, fifty percent of the of the physicians at US Renal have patients who are at DaVita or Fresenius centers as well, and they want to be able to use the product for their patients there. And so that becomes our greatest kind of advantage is that you have that advocacy being driven by those physicians for us as well. And many of them are the ones who are raising their hands to be part of this pilot that’s going to start in the third quarter.

Matthew Caulfield, Senior Biotech Analyst, H. C. Wainwright: Very exciting. So the team has also mentioned commercial contracts covering approximately one hundred percent of dialysis patients. For people that aren’t as familiar with the kidney space, maybe you could speak to how the strategy has started in sort of the small to mid dialysis organizations, and this is all targeted towards dialysis organizations. It’s not like

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: That’s right.

Matthew Caulfield, Senior Biotech Analyst, H. C. Wainwright: Maybe other conventional drugs and biotech where you’re looking at different sales format.

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: That’s right. Yeah. And and, you know, it’s it’s really a lot of it is driven by the reimbursement system. Mhmm. So the dialysis organizations are financially liable for the cost of the product, the cost of treatment, so they’re looking for reimbursement.

Right? And that reimbursement, they want to have positive economics about it. They want to make money. And so contracting is that piece that allows them to buy it at less that they’re getting reimbursed at. It creates positive economics as TDAPA was intended to do.

It gives an incentive for dialysis organizations to use innovative products. And as far as I know, we are the only TDAPA product that had one hundred percent of patients under the care of a dialysis organization with contracts in place. Now that’s step Step two is protocol development. That’s where our medical team helps educate the medical teams within the dialysis organizations to make sure that they’re aware and educated about the data that they can appropriately select the patient population that they want to use product in. We have protocols in place with many of the MDOs and small dialysis organizations.

We have a protocol in place with the LDO that is going to be starting the pilot. And we’re still working on the protocol with the other large LDO, who hasn’t yet developed a protocol. So that’s the second piece of it. And then obviously, you you you expand it to usage. Very different from the retail, pharmaceutical model where Right.

Any doctor can write a prescription and a person goes to your retail CVS or Walgreens and picks it up and charges your insurance company. It’s a very different two step model. You’ve got a contract with DOs, get them on board with a protocol, then you can talk about prescribing, with the physicians.

John Butler, CEO, Akebia Therapeutics: You know, it’s funny. It it does add a level of complexity to the commercial, process so that you have these LDOs who are, you know, kind of in the middle, if you will. Sure. But when you look at at again, it’s only one quarter, so it’s early days. But when you look at the prescribing that we’ve had, if you create that right contracting environment where you, you know, create a place where the business side of of a dialysis provider is is open to the product being used, almost happy to see the product used Mhmm.

You actually can drive, in some ways, a faster uptake. I mean, I’ve been working in the dialysis space for a long, long time. And as I think back, I mean, this really feels like one of, if not the fastest dialysis launch that I’ve seen. Again, through the end of the quarter, ten or twelve weeks in, right, so we don’t wanna get over our skis. But, you know, having that really understanding dialysis, and maybe that’s one of our competitive advantages as a company, you know, understanding and putting the right contracts in place, you know, to create that that incentive.

And that’s why TDAPA was put in place. I mean, CMS knew that they were gonna spend more money, they said in a in a bundled environment, you can’t incorporate a new innovative product. So we need to create an incentive so that dialysis providers are willing to allow physicians to to use the product, and, that’s what TDAPA has done. And for us, because ninety percent of patients need to be treated for anemia, it’s central to their to their care. It’s really created an opportunity for us, and we’re really excited about, you know, the speed at which we’re, we’re moving.

You know, we got to keep going. No one’s slowing down, but it’s, it’s a great start.

Matthew Caulfield, Senior Biotech Analyst, H. C. Wainwright: Yeah. Absolutely. So interestingly, you mentioned TDAPA, so that’s within the CKD and the anemia dialysis market, stands for the Transitional Drug Add On Payment Adjustment or Reimbursement.

John Butler, CEO, Akebia Therapeutics: Well done.

Matthew Caulfield, Senior Biotech Analyst, H. C. Wainwright: So maybe at a high level, you know, for people that are newer to the story, can you describe the main considerations there and how that plays into a successful commercial launch for Vafsio?

John Butler, CEO, Akebia Therapeutics: Yeah. I mean, it is it is a question we get from investors, frequently. Like, you know, you get to this dialysis reimbursement is just Yeah. This extra complexity to it, so, you know, it sort of scares people off. But, you know, it really was what I said.

CMS recognized that it is impossible to put a new innovative product into place. The dialysis providers for a for a fee for service pay patient, they get paid $274, I think it is 75 maybe now, per dialysis session, a hundred and fifty six dialysis sessions a year. That’s what they get paid to offer basically four hours of pretty intense medical care. So they are on a very, very thin margin for that. And you say you’re bringing in a new product, it’s very hard to say, okay.

We’re we’re willing to to to use that. We’re willing to let physicians see where they should use that. So CMS created this this TDAPA program, and this was in the the first Trump administration, to allow physicians to try the product. So what basically they do is CMS pays for this drug, Vafsio, outside of that $274 bundle payment, which includes the payment they for EPO. Right?

That includes the money for EPO today. But they’re gonna pay for Vafsio outside of that bundled payment on an ASP basis for two years to allow physicians and dialysis providers to figure out where it fits in the treatment paradigm. Mhmm. And then there’s a whole mac mechanism post TDAPA for the next three years to pay for it that’s too complicated to talk about now and doesn’t do much for us. But it is, you know, this is working.

This is why, as Nick said, we have to put these contracts in place. It’s why we have to, you know, create that economic, environment for the dialysis providers to, you know, be able to see your return and say to physicians, go ahead. Write the product, for the people you feel it’s appropriate for. And, you know, that’s it’s not you know, we start throwing around the acronyms. It seems complicated, but it really is simply a different way to create access, for the for the drug, and and it’s it’s done that for us to this point.

Matthew Caulfield, Senior Biotech Analyst, H. C. Wainwright: Sure. I mean, also facilitates the pricing in in your favor for the launch for those first couple years at least.

John Butler, CEO, Akebia Therapeutics: That’s correct. Yeah. And that’s a really good point. I mean, it it does, you know, during the TDAPA period, you know, we we launched at a WAC price of $15,500, which is the starting dose, you know, WAC price. No one’s paying that.

Everyone gets a discount from that. Mhmm. But in that post TDAPA world, that’s this is very unique, right, that we will have to have a price that’s basically the same, as what dialysis providers are paying for ESAs today. And on average, that’s about $2,500 a year. So after TDAPA, we will have to bring our price down.

But, of course, not every patient has a TDAPA has access to TDAPA now. It’s only fee for service patients. It’s about forty ish, forty five percent of the of the dialysis population. Mhmm. Post TDAPA, the price is lower, but everyone has access to the product.

So you’re driving the demand and usage from the physicians today. It’s like expanding your your payer universe, sort of, right, as you as you go. Suddenly, more patients have access, albeit at a lower price, you drive that, continued uptake in volume, and that’s why we’re doing things like the voice trial, you know, to continue to generate data to continue to to grow the product.

Matthew Caulfield, Senior Biotech Analyst, H. C. Wainwright: Mhmm. That’s very helpful. Just to wrap up on the pilot trials, is there a specific timing that’s useful for investors to be following right now, maybe for the larger dialysis organizations?

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: Yeah. And so we’re working with that LDO. We’re expecting the pilot to be started in quarter three.

John Butler, CEO, Akebia Therapeutics: Mhmm. So when you think about, you know, translating that to to revenue, we we really think about q two as continues to be driven by the small and medium providers. Right? Again, which there’s lots and lots of room to, to grow, in that population with a 50,000 patients in that population. We’re not worried about that.

Q three, if the pilot is, you know, as, as advertised, you know, 200 sites, it could be, you know, 2,000 patients, you start to see that in q three. But then the doors are really opened in q four, and that’s where this is when we think about kind of step step up, of the launch, which is not an unusual thing to see. But, you know, I think you’ll see that even more granular level when

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: you have these dialysis providers in between. And never safe to kind of correct your boss on stage, but Please do. 200 sites is 20,000 patients.

John Butler, CEO, Akebia Therapeutics: Oh, I’m saying that maybe there’s 10 per

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: Oh, 10% site. Yeah. Would be part

John Butler, CEO, Akebia Therapeutics: of You’re absolutely right. There’s many more than that patients there, but they wouldn’t put everyone on now. Right? So maybe they’ll put 10. Maybe it’s 20.

I think the way they did, and correct me if I’m wrong, which you’re gonna do whether I want you to or not, is once a site is part of the pilot, they can put on any patient they want Who has reimbursement. Who has reimbursement. And as a matter of fact, the more the merrier because they wanna really pressure test the the operational That’s correct. Environment there.

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: Yeah. And we talk about fee for service. John mentioned 40 to 45% are fee for service. Medicare Advantage is about another 40% of patients. The LDOs have significant more leverage in negotiating with Medicare Advantage plans.

So we do anticipate that the pie that we’re going after isn’t just fee for service. It’s going to be slightly larger than that depending on their Medicare Advantage negotiations.

John Butler, CEO, Akebia Therapeutics: Yeah. And I think we’ve mentioned before, mean, we don’t wanna get too, ahead of ourselves, but we expected it to really be just fee for service in the beginning. And, you know, the data that we’re seeing and what is the percentage that we see in Yeah.

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: We see up to 20% of reimbursement happening in other plans outside of Medicare. Outside of Medicare. Fee for service.

John Butler, CEO, Akebia Therapeutics: That’s correct. Right. So mostly those are MA.

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: That’s right. Medicare Advantage.

Matthew Caulfield, Senior Biotech Analyst, H. C. Wainwright: Very helpful. So I also wanted to just touch on the market opportunities. So we consider Vovsio positioned to address CKD anemia in patients undergoing dialysis. There’s also patients in the non dialysis market. Can you further discuss the opportunities looking at non dialysis?

John Butler, CEO, Akebia Therapeutics: Yes. It is a very, very significant opportunity for us. And so when you think about market size, if you look at stage four and five patients, CKD patients, so, you know, as their GFRs are declining, you know, they have they’re they’re characterized as stage one, two, three, four, five. So four and five is really where you see anemia because their kidneys are failing. Kidneys may keepo, and they they they become anemic.

About just over half a million five hundred fifty thousand patients are anemic who fall into the stage four and five category, which makes it about the same size as the dialysis market. It is much more valuable, though, because as I said, post TDAPA, we have to bring our price down in dialysis. We have a much more traditional market in nondialysis, where 50% are commercial pumpkins, 50% part d Medicaid. So, you know, there, when you think about our our average price per patient per year, which is it was about 15,500, even when you take a a normal, quote, unquote, gross to net, hit it for compliance as well, you’re still talking about an average, price per patient, probably four to five times. So while the patient numbers are the same and dialysis ESA market for that 205 hundred dollars a year is a billion dollar market.

Multiply that by four or five in the nondialysis market. So the opportunity is much, much greater.

Matthew Caulfield, Senior Biotech Analyst, H. C. Wainwright: Excellent. I know we just have another minute or so here, but just to wrap things up, I wanted to touch on the pipeline. You mentioned the voice outcomes trial for VAVSIO. There’s also the planned Phase III for VAVSIO in the CKD anemia patients that are not on dialysis.

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: That’s

Matthew Caulfield, Senior Biotech Analyst, H. C. Wainwright: right. Any important high level time frames or catalysts related to each of those trials? Well,

John Butler, CEO, Akebia Therapeutics: VOICE in our last earnings call, we said it was, about sixteen hundred and fifty out of 2,200 patients, enrolled. So I haven’t gotten an update since then, but doctor Block, who’s who’s running that study, is he’s moving at it’s an amazing rate of of enrollment. I’ve I’ve never seen that. So I hope and believe that speaks to physicians’ excitement about the product overall. So hopefully soon, we’ll be able to talk about, full enrollment, and hopefully by the middle of the year.

Nondialysis study, we we’re we’re we’re engaging with the FDA, on that study. We’re planning a Type C meeting. We don’t have a date for that yet, but we’re working on, initiating a Phase three trial there. And our plan is to start that trial before the end of the year because we want to get data in front of the FDA as quickly as possible to expand that label because physicians are waiting. Every time I talk to a physician, they say we want to use it in nondialysis.

So stay tuned. We’re looking forward to talk more about that and obviously the continued success of the launch.

Matthew Caulfield, Senior Biotech Analyst, H. C. Wainwright: Excellent. Well, Nick and John, this has been really helpful to learn about Akebia. We’re very excited to see this year’s progress.

John Butler, CEO, Akebia Therapeutics: Matt, thank you so much

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: for the invitation. Absolutely.

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