Akebia at H.C. Wainwright: Strategic Insights on Kidney Care Products

On Monday, 14 July 2025, Akebia Therapeutics (NASDAQ:AKBA) participated in the H.C. Wainwright 4th Annual Kidney Virtual Conference, unveiling strategic insights into its kidney care products. The company highlighted the successful launch of its novel oral therapy, Vafseo, while acknowledging challenges in achieving wider market adoption. Akebia’s focus on innovation in chronic kidney disease (CKD) treatment positions it for growth despite competitive pressures.

Key Takeaways

• Akebia launched Vafseo in January, with over 640 physicians prescribing it in the first quarter.
• The company plans to expand Vafseo’s market to non-dialysis patients, a multibillion-dollar opportunity.
• A pilot program with a large dialysis organization is set for Q3 to enhance Vafseo’s integration.
• Akebia’s pipeline includes AKB-909O for acute kidney injury and AKB-10108 for retinopathy of prematurity.
• Auryxia sales remain strong, providing potential revenue upside.

Financial Results

Auryxia:

• Despite the launch of an authorized generic, clinical demand remains strong.
• Revenue from Auryxia is considered a potential growth area.

Vafseo:

• Initial dose priced at approximately $15,500 per year.
• Post-TDAPA pricing expected to align with standard ESA prices at about $2,500 per year.
• Pricing for non-dialysis patients could be four to five times higher, tapping into a $4-5 billion market.

Operational Updates

Vafseo Launch:

• Launched in January with strong initial adoption.
• A pilot program with a large dialysis organization is planned for Q3, targeting 75 to 200 clinics.
• Broader availability of Vafseo is expected in Q4.
• Plans to initiate a Phase 3 study for non-dialysis patients in the second half of the year.

Future Outlook

Vafseo Growth:

• Large dialysis organizations expected to drive growth in the second half of the year.
• Akebia aims to establish Vafseo as the standard of care for both dialysis and non-dialysis patients.
• The VOICE trial aims to demonstrate a 10% reduction in hospitalization and mortality.

Pipeline Expansion:

• AKB-909O for acute kidney injury is expected to enter clinical trials this year.
• AKB-10108 for retinopathy of prematurity is under development.

Q&A Highlights

Vafseo Differentiation:

• Vafseo offers oral administration with a gentle rise in hemoglobin levels.
• Lower dose titrations have been demonstrated in pivotal trials, potentially reducing hospitalization and mortality rates.

NDD Opportunity:

• Significant unmet need for oral therapy in pre-dialysis anemia.
• Pricing for non-dialysis patients expected to be substantially higher than for dialysis patients.

TDAPA:

• The TDAPA component incentivizes dialysis organizations to adopt innovative therapies like Vafseo.

For further details, readers are encouraged to refer to the full transcript of the conference call.

Full transcript - H.C. Wainwright 4th Annual Kidney Virtual Conference:

Matthew Caulfield, Senior Biotech Analyst, HC Wainwright: Alright. Hello, everyone, and welcome alright. Hello, everyone, and welcome to HC Wainwright’s fourth annual kidney conference. My name is Matthew Caulfield. I’m a senior biotech analyst here at HC Wainwright.

We next welcome Akebia Therapeutics, and we’re glad to welcome Nick Grund, chief commercial officer at Akebia. So welcome, Nick. Great to see you this morning. Thanks for having me. Yeah.

Of course. Maybe to start off, could you provide a brief overview of Akebia and its commercial products for CKD patients that are on dialysis?

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: Yeah. Absolutely. Akebia is a fully integrated biotech company. We got founded in 02/2007. We’ve got two commercial products.

Importantly, we’ve got a a sales team that has deep renal experience. We’ve got an r and d team that’s demonstrated the ability to to, develop compounds and bring them through through clinical studies and eventually approval. And we we’ve got a pipeline of early stage assets. Importantly, we’re focused on really bettering the lives of people with kidney disease.

Matthew Caulfield, Senior Biotech Analyst, HC Wainwright: Mhmm.

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: As our two assets our two assets is our Auryxia, first off. It’s about ten year old phosphate binder. Mhmm. First indication is for the control of serum phosphorus in those patients that are on dialysis. Its second indication is for iron deficiency anemia in adult patients in nondialysis.

So not our our first roadshow with anemia. There’s about a 90% overlap between our Rixia physicians and Vassio physicians, target physicians. And that brings us to Vassio. We launched Vassio back in January. It’s indicated for the treatment of anemia due to chronic kidney disease and adult patients receiving dialysis.

You know, it’s an oral HIF PHI, a new mechanism of action action. It stands for epoxy inducerol factor prolyl hydroxylase inhibitor. So a mouth fill.

Matthew Caulfield, Senior Biotech Analyst, HC Wainwright: Mhmm.

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: Really quickly, that mouth fill really means that it stimulates the body’s natural response to hypoxia, which enhances the body’s natural production of erythropoietin to control it. Mhmm.

Matthew Caulfield, Senior Biotech Analyst, HC Wainwright: Mhmm. Mhmm. No. That’s great. So considering that kidney patients can otherwise rely on erythropoiesis stimulating agents or ESAs and iron supplementation therapy, for example, What do you think are the greatest unmet needs facing CKD patients, you know, based on standard of care that they’ve been accustomed to?

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: Yeah, Matt. You’d be surprised. You know, ESA agents have been on on the market thirty years. And despite this, nearly twenty five percent of patients are struggling to hit their hemoglobin targets and falling in and out of the range. And despite this this large percentage of patients not quite getting to goal, there’s been very little innovation in this area until Vazio.

You know, nearly 30 of those patients who are on ESRAs on a high doses of ESAs. With those higher doses of ESAs come increased risks of major cardiovascular events.

Matthew Caulfield, Senior Biotech Analyst, HC Wainwright: Mhmm.

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: Now, additionally, as an oral therapy, patients can conveniently take Vascio at home, which is ideal, particularly for those patients who are are getting their dialysis at home. And so though broadly indicated, those two populations, which physicians think of first, represent about forty percent of the dialysis patients.

Matthew Caulfield, Senior Biotech Analyst, HC Wainwright: Mhmm. That’s very helpful. I mean, to kind of drill in a little bit more to what you described, so Vapsio is unique as an oral tablet. You mentioned it’s the HIF PH inhibitor as sort of a novel mechanism of action treating anemia, CKD dialysis patients. Are there any other main points, or can you discuss a little further the relevance of the this differentiation within the CKD market?

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: Yeah. Thanks. You know, it’s really interesting. When you give an ESA, you see these large spikes in hemoglobin with a a a reduction, and then they give the next dose. It’s another large spike in hemoglobin and a reduction.

With Vavsio, given its unique mechanism of action, you re really see really small changes in EPO over time. And that lower level of EPO changes results in a gentle rise in hemoglobin for those anemia patients. You know? Secondly, since it’s working upstream, from where ESAs work, we also note that there we’re seeing, iron mobilization, which may be linked to more efficient use of iron. It’s important for creating red blood cells.

Mhmm. And in the pivotal InnovAATe study that led to our approval, it demonstrated also lower dose titrations for the product. So you’re not having to titrate patients as often, which is which is a benefit to the clinic staff.

Matthew Caulfield, Senior Biotech Analyst, HC Wainwright: Mhmm. Absolutely. And being oral. I mean, I think that’s that’s a very helpful, therapy as well. So you mentioned Vapsio launched commercially very recently back in January of this year.

Maybe you could tell us a little bit of how the launch has progressed, any early trends you’re observing among uptake, you know, enthusiasm, kind of where things stand for the initial launch stages.

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: Yeah. So we’re still working to close out q two. So so, really, when I look at the first quarter of launch, we launched back in January. Overall, super pleased with how the initial launch of Vasio went. When I think about a launch, I think about kind of breadth and depth of physicians writing.

You know, breadth is is how many are writing, and and over 640 had written written Vasio in the first quarter of launch, which is which is super good. Most of those physicians are within US Renal Care. They were the fastest to move. We have great advocacy at US Renal Care, but certainly expanding beyond US Renal Care is important. The second I think about is depth of prescribing.

That’s the number of prescriptions of physician rights. And on average in q one, we saw about 12 prescriptions per physician. You know, that range was super broad. We have still folks in the, we’ll call it, trial phase, one to five prescriptions. But on the other side of that spectrum, we have physicians that are over a 100 prescriptions, which is really tending towards full adoption.

And

Matthew Caulfield, Senior Biotech Analyst, HC Wainwright: so Okay.

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: You know, obviously, full adoption is where we wanna get to, but that 12 would demonstrate there. Still, most folks are still in what I’ll call the trial and early adoption phase as opposed to complete adoption.

Matthew Caulfield, Senior Biotech Analyst, HC Wainwright: Understood. So that kind of parlays into the next question. You know, we know uptake in the kidney space has some nuances. Can you talk a little bit about the path from initial small and mid sized dialysis organizations? I know you mentioned US Renal Care and how that can progress ultimately into the large dialysis organizations or the LDOs.

That’s kind of a unique component to the the kidney space.

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: Yeah. You used kinda two words that are often put with dialysis, nuanced and unique. Right? And and so when we think about the dialysis space, though it is unique, it’s actually unfolding really closely to how we thought about it. You know, as we thought about the launch, we always anticipated that the small to midsized dialysis organizations would go first.

They would be faster through the launch process. You know, that segment is about a 150,000 dialysis patients. So a large segment, but they were gonna move move faster. And we saw that. US Renal Care being the most you know, they’re the third largest dialysis organization with about 36,000 patients.

So not small by any means, but certainly not the size of an LDO. You know, an LDO or a large dialysis organization, roughly 200,000 or above, that’s Fresenius and DaVita, they go a little bit slower. You know? They’ve got more systems to to integrate. They’ve got more decision making layers between top to bottom.

And, certainly, while we’re expecting it in we expected in q one to be small to midsize, that to fuel our growth into q two, we anticipate in the second half of the year, LDOs will start to become a more a major player in that second half growth.

Matthew Caulfield, Senior Biotech Analyst, HC Wainwright: Mhmm. That’s great. Another important component to therapy adoption and access in the kidney space is the TDAPA component. Can you explain how that factor plays into the launch patient access and the time frames related to that and and how that’s impacted initial launch.

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: Yeah. TDAPA, you know, another unusual nuance of of dialysis. So it stands for transitional drug add on payment adjustment. And, really, what it is is, first, a drug has to qualify for TDAPA, which Vasio has done. And it it is under the perspective payment system, which applies to all ASRD products.

And why they developed TDAPA CMS was they were worried that having one flat bundled rate per session would disincentivize dialysis organizations for giving innovation a try. And so what they did is they set up this reimbursement mechanism known as TDAPA that really calls for a payment in addition to their bundled rate. So it’s it’s it’s a payment they receive for qualifying drugs, in addition to that bundled rate, and it really is there to incentivize folks to figure out how to operationalize innovation into normal treatment. It lasts about two years. After that, there’s a whole convoluted mechanism of what happens for the next three, etcetera, etcetera.

But the long and short of it is to be successful, not only do you have to have good economics during TDAPA, you have to provide dialysis organizations with certainty post TDAPA around pricing, and we’ve done that. We’ve contracted and worked with dialysis organizations to have their price post TDAPA be at approximately the standard ESA price at about $2,500 a year. Importantly, while that is a price reduction from our initial starting dose price of about 15,500 per year, now this is a billion dollar market at $2,500, per year. And so, you know, obviously, to be successful, we need to do that to provide that predictability.

Matthew Caulfield, Senior Biotech Analyst, HC Wainwright: Mhmm. Understood. Can you tell us a little bit more about the upcoming pilot program for Vavsio with the large dialysis organizations? What expectations could look like for that development? I know you just mentioned the second half twenty five Yeah.

Kind of overall for the LDOs. Can you tell us a little bit more about sort of that evolution there?

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: That’s kinda we’ve talked about. We’ve had one of the LDOs is going to be doing a pilot program. You know, one of the reason that LDOs take a little bit longer is sometimes they wanna test the myriad of systems that they have in order to operationalize a new product. And so one of the large e the LDO is gonna initiate a pilot in q three. It’s a substantial pot size pilot between seventy five and two hundred clinics.

If you think about 200 clinics, you know, the third largest dialysis provider has about 700 clinics in total. So 200 is pretty sizable. It’s what they call an operational pilot. They’re not there to to prove safety or efficacy. They’re really there to test the system.

Can a doctor prescribe it? Does the patient get that prescription delivered to their home? Does the system indicate there’s a refill? Does it help them control formulary of which patients have reimbursement for for the product? So so pretty much nuts and bolts of kind of how you get a new product prescribed to a patient.

Since it is an operational pilot, we’re thinking two to three months long for which they’ll open up Vascio use more broadly. You know? And so, certainly, you know, moving from 75 to 200 clinics to over 200,000 patients is is a massive opportunity for us, and we’re likely to see that opening up in quarter four of this year.

Matthew Caulfield, Senior Biotech Analyst, HC Wainwright: Mhmm. Excellent. Maybe if we could just change gears briefly to the other approved product, Auryxia or ferric citrate. So that’s used for hyperphosphatemia. As you mentioned, that’s kind of the primary indication.

With that product losing exclusivity in March, what’s the best way to think about sales in the near term and then kind of transitioning to focusing on Vafsio moving forward?

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: Yeah. When we think about Auryxia, frankly, we’re really pleased with how Auryxia has done. It lost exclusivity back in March. And at that time, the authorized generic launched. And so there’s one generic, the authorized generic on the marketplace today.

But what we’ve seen from Vavsia, from Auryxia is really strong clinical demand for the branded product. That’s one in due to its strong clinical profile. Physicians are well aware around what Auryxia can do for their patients, but it’s also the economic value proposition that we had in our contracting broadly with DOs. You know, when we think about Auryxia, while we’re really pleased with having that revenue, it could change at any moment. You know, a second generic can enter that marketplace, which would have that market change really quickly.

And so internally here, we’re really conservative for how we think about it. And and so, you know, every day that goes by is a day that we view as upside for the product historically. And so, you know, as we we look to the future, we’re not we’re not hedging Auryxia rev we’re not keeping Auryxia revenue front of mind, if you will, in terms of what we do to be successful as a company. The only thing I’ll say, Matt, is is, you know, Auryxia, with over ten years experience, allowed us to foray into Vaseo. You know, we no longer promote Auryxia, despite its strong sales, in quarter one.

And so we are a 100% focused on Vaseo.

Matthew Caulfield, Senior Biotech Analyst, HC Wainwright: Mhmm. Excellent. So with Vafsio, you know, offsetting generic impact on Oraxio ultimately as we move forward, can you further discuss the market opportunity for Vafsio in dialysis? You’ve kind of covered that, but also thinking about nondialysis patients and how that could be sort of a commercial evolution for the product.

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: Yeah. Absolutely. I mean, our intention with Vafsio is to is to have Vafsio become the standard of care. You know, in order to become the standard of care, you need things like clinical differentiation, which we already talked about with the MOA. You need increasing real world physician experience.

You know, physicians have to be using the product because as any new product launches in this space, it takes a little bit of time for physicians and and staff to figure out how to use it. Mhmm. You need this kind of post head up transparency and and contracting piece of it. But the last piece you need in dialysis is continued data generation. Right?

So how do you build the profile of a product over time? An example of that would be the voice trial where that USRC is doing and and doctor Block. That program is, and that study is designed to show a ten percent decrease in hospitalization and mortality.

Matthew Caulfield, Senior Biotech Analyst, HC Wainwright: Now Mhmm.

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: It’s pretty obvious hospitalization and mortality are benefits to patients, but there are also benefits to dialysis organizations. You know, if you look at a ten percent reduction in hospitalization, on average, a dialysis patient’s hospitalized about two times a year, costs on average about 60,000 times each it’s $60,000 each time they’re they’re hospitalized, And the dialysis organizations are on the hook for for a large part of that. And so saving 10% of that is a meaningful number per patient. Additionally, the patient, instead of being in the hospital, is in the chair receiving their dialysis, which they’re they’re earning revenue on. So Mhmm.

Continuing to increase data and and and, the value proposition around, Vascu is gonna be important in dialysis.

Matthew Caulfield, Senior Biotech Analyst, HC Wainwright: No. I think that is complete. Yeah. That makes sense.

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: The best way to create a standard of care in dialysis is to actually have patients start dialysis on Basio. And so that’s where NDD starts to be so important. You know, when you look at a patient who starts dialysis with their anemia well managed, their outcomes are far better than those patients who start dialysis being anemic. And so, obviously, being well controlled in the NDD space through Vaseo is really important. NDD’s a multibillion dollar opportunity.

You know, it’s got about the same number of patients as dialysis does, but the pricing is more traditional. It’s Medicare Part b. It’s Medicaid. It’s commercial insurance. And so we expect pricing instead of the $2,500 per year that we see in dialysis will be four to five times greater than that.

Therefore, if dialysis is a billion dollar opportunity, nondialysis is four to five times that. And and we as a company working super hard there. We have we’ve received feedback from the FDA on a protocol. We’re engaged with them around that protocol and NDD, and we’re planning for a type c meeting with the plan to initiate a phase three study in the second half of the year.

Matthew Caulfield, Senior Biotech Analyst, HC Wainwright: Excellent. So that’s very exciting. Do you feel I know you you mentioned the, you know, exploration of decreasing hospitalization and mortality. Do you feel those are the biggest levers to pull in terms of differentiating Vapsoe, you know, in terms of your your mention of wanting to become standard of care? Are those sort of the greatest components to focus on, or are there other aspects that could help, you know, push Vapsio into the into the the forefront?

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: Yeah. Certainly in dialysis, you know, obviously, hospital and mortality are the are the holy grails. If you can Yeah. Those, that’s that’s great. In NDD, it’s really interesting is is every time I’m out with a physician, it’s got a a large unmet medical need.

You know, only about thirty percent of patients actually receive treatment for their their their anemia in predialysis. You know, right now, if you look at ESAs in that space, they’re really used as rescue therapy. So a patient’s hemoglobin drops. In some cases, they wait to a hemoglobin of nine or below to treat, and then they’ll treat. They’ll get them in the range.

They’ll wait till it comes back down to nine. They’ll treat again, and it creates what they call hemoglobin cycling. Right? And hemoglobin cycling has has demonstrated that it actually increases safety issues associated with anemia management. And so a lot of times, physicians would rather not treat, in that space.

Every physician we’ve talked to has said that an oral therapy to help treat anemia in nondialysis would be super, super, important for patients.

Matthew Caulfield, Senior Biotech Analyst, HC Wainwright: Mhmm. And very differentiated, obviously. Absolutely. Yeah. No.

That’s that’s great. Kind of one one nuanced question. So for Vascio, there’s the distinction around dose titration once patients are on therapy. Maybe you could just briefly talk about how dose dose titration for optimum benefit could play into prescriptions, potentially refills at higher doses, or is that something that’s kind of on the radar commercially?

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: Yeah. No. It’s it’s it’s a super, super important question. If you remember, the starting dose of Vavsio is three hundred milligrams in dialysis. Mhmm.

And then dose based on a patient’s hemoglobin, they would titrate up from the up or down from there. Mhmm. What we’ve seen in the first quarter launch is is about a third of our prescriptions were refills. And what we saw in those refills is doctors titrating up. They were titrating up to a level that was about very, very similar to what we saw in our Innovate pivotal studies, which is about a 40% increase in dose.

And so when we talk about an average price of 15,500 per year, that was at the starting dose. Imagine a dose where a patient is is well controlled being about 40% higher than that.

Matthew Caulfield, Senior Biotech Analyst, HC Wainwright: Excellent. That’s very helpful. You know, as we get closer to the end here, I wanted to make sure I asked you, what do you think are the most important near term catalysts? I know you mentioned the LDO progress. What what should like, what should be on investors’ radars as we look to the next coming quarters?

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: Yeah. It it’s really Vazio, Vazio, Vazio. So first Mhmm. You know, unlocking that additional deal. I think getting that pilot started successfully in the third quarter is critically important.

And then also coming out of that pilot and making it broadly available, really important.

Matthew Caulfield, Senior Biotech Analyst, HC Wainwright: Mhmm. Mhmm.

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: The second thing is voice enrollment. You know, that study at the end of q one was about 75 enrolled, and we’ve seen very strong enrollment since. And so getting voice fully enrolled is important because the quicker you get enrolled, the quicker you get an answer. And then that hospitalization and mortality is important. And lastly is progress on NDD, making sure that we’ve got a path forward with the FDA and can start the the study as expeditiously as possible.

Matthew Caulfield, Senior Biotech Analyst, HC Wainwright: Mhmm. Terrific. And maybe just to wrap things up, do you feel there are certain aspects of the Akebia platform or story that are currently underappreciated by investors or the market? Like, any specific points that you’d like to to help, you know, drill home for folks?

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: Yeah. It’s interesting because, you know, investors are really focused on Vasio, and that’s probably where they should be. But we’ve actually got a a pipeline of HIF assets out there. The first, a k b AKB 909O, that should be in the clinic this year where we’re we’re studying acute kidney injury, you know, significant unmet need there. Quickly following on that, we have AKB one zero one zero eight.

That’s HIF technology where we’re studying for the prevention of ROP or retinopathy of prematurity. Mhmm. That’s an orphan disease where we may actually be able to impact blindness in premature babies. And so really interesting early stage assets in our hit platforms that that we’d love to talk about more. But, frankly, until we demonstrate continued success with Fatsio, it’s hard to get folks to focus on any of those cool things going on in our pipeline.

Matthew Caulfield, Senior Biotech Analyst, HC Wainwright: Sure. No. That that’s very helpful and very exciting. It’s gonna be great to see the progress with Vavsio and, you know, the evolution of the platform in the near term here. So with that, I’d like to thank Nick and Akebia Therapeutics for a great discussion on their platform.

This is really helpful. And thank you again, everyone, for joining us.

Nick Grund, Chief Commercial Officer, Akebia Therapeutics: Appreciate it.

Matthew Caulfield, Senior Biotech Analyst, HC Wainwright: Thanks.

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