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Earnings call · FY2026 Q3

Akebia Therapeutics, Inc. (AKBA) Q3 2026 Earnings Call Transcript

Concluded Nov 5, 2026 Audio replay Verified speakers
Nov 5, 2026 43:59 46 turns
Period
FY2026 Q3
Runtime
43:59
Sources
4 artifacts
Revenue $36.90M -37.2% YoY
Diluted EPS -$0.05
Gross margin · derived Q4 82.8% -1.2 pp YoY
Net income -$14.35M -2758.1% YoY
Open full screen 8-K 10-Q

Transcript & audio

Verified speakers 43:59 Audio
Operator

Good day, and thank you for standing by. Welcome to the Akibis Third Quarter 2026 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to turn the conference over to your first speaker today, Mercedes Carrasco, Senior Director, IR. May begin.

Mercedes Carrasco Head of Investor Relations

Thank you, and welcome to Akebia's third quarter 2026 financial results and business updates conference call. Please note that a press release was issued earlier today, Thursday, November 5th, detailing our third quarter 2026 financial results, and that release is available on the investor section of our website. For your convenience, a replay of today's call will also be available on our website after we conclude. Joining me for today's call, we have John Butler, Chief Executive Officer, and Eric Ostrowski, Chief Financial and Chief Business Officer. Dr. Steven Burke, our Chief Medical Officer, and Nicholas Grund, Chief Commercial Officer, are also available for questions. I'd like to remind everyone that this call includes forward-looking statements. Each forward-looking statement on this call is subject to risks and uncertainties that could cause actual results to differ materially from those described in these statements. Additional information describing these risks is included in the financial results press release that we issued on November 5th, as well as in the risks, factors, and management discussion and analysis section of our most recent annual and quarterly reports. With that, I'd like to introduce our CEO, John Butler.

Thanks, Mercedes. Good morning, everyone, and thank you for joining us today. Late last month, Akibe joined our peers at ASN Kidney Week in Denver. I left the event with two important takeaways. First, I heard tremendous excitement about the voice trial data that Dr. Block of U.S. Reinal Care presented. We believe the data, which demonstrated a clear and compelling hospitalization outcomes benefit for Vatidustat versus an ESA. Dose in a regimen that most dialysis providers have chosen to implement will have dialysis organizations thinking differently about Vafsio and, over time, has the potential to drive Vafsio to become standard of care. Second, the spotlight continues to shine on rare kidney disease therapeutic product development, and we're excited about the potential to show meaningful differentiation with our mid-stage pipeline assets across multiple rare kidney indications. We believe this would represent significant value for our shareholders. Now, with this backdrop, let me walk through Q3, starting with our commercial business. We're pleased with the pace at which we're adding patients from the midsize dialysis providers, including USRC, DCI, and IRC. Last quarter, the number of patients on Vafcio increased to about 11,500 patients on therapy, representing about 20% of patients treated for anemia within these three dialysis organizations. Also important, 25% of patients that had previously discontinued therapy have restarted. Even with this progress, I believe we have significant room to continue driving growth, even within the midsize dialysis providers, but obviously and especially at the large dialysis organizations. Avasio net product revenues were $14.8 million for the quarter. This is only a 3% increase versus the third quarter of last year, despite approximately 140% growth in the number of patients on therapy. There are a few somewhat related factors at play, but it was predominantly a drawdown of inventory based on a lower dose and dialysis compliance rate. If you recall, we told you that we're no longer getting data on average dose at providers who've moved to TIW dosing. When our largest customer looked at their utilization, they adjusted their purchases based on the average dose they were seeing versus what they expected. Our customer made their inventory assumptions expecting an average dose of 900 milligrams per dialysis treatment, but the average was about 810 milligrams. Even more impactful, patients have been less compliant with their dialysis sessions than expected. If a patient doesn't show up for dialysis, the patient doesn't receive a Vapsio dose if the unit is using observed dosing. These two factors combined meant that there was more inventory in their clinics at the end of last quarter, which impacted their purchases this quarter. So to make it very clear, when we use the updated dose and compliance data with the number of patients on therapy, end-user demand was between $17 and $18 million for Q2 and between $19 and $20 million for Q3. Another takeaway from my conversations at ASN is that while dialysis providers have protocols in place, as individual physicians start using Vapcio in greater numbers, they're using their own strategies to utilize the product and bring patients into or keep patients in the hemoglobin target range. It shouldn't be surprising. It took 20 years for physicians to figure out how to dose ESAs. It's gratifying to see prescribers recognize the benefits of Vafsio for their patients, though it would be easier for us if their approaches were a little more consistent. Our focus is to continue to drive more patients onto therapy and support physicians as they look for the best outcomes for their patients. Beyond the reduction in inventory based on dose and dialysis compliance, as we approach Vafsio's January 1, 2027 Tdapa expiration, We expect a continued reduction in inventory levels. No provider wants drug on the shelf that it bought at a higher price when it no longer gets to bill for that price. Now, we're working proactively to manage this dynamic. To be clear, for Q4, we expect to see continued growth in patients on therapy. That's the most important metric for the long-term growth of the product. On January 1st, we begin our post-TEDAPA launch. On that day, Vafcio access will expand beyond the Tdapa-only patients to nearly all clinically eligible patients. Treatment with Vafcio will be reimbursed as part of the dialysis bundle payment, and dialysis organizations will no longer be able to bill separately when they use the product. As we've always said, post-Tdapa will price Vafcio to remain competitive with ESA pricing to ensure providers can access an innovative treatment for patients Even within the economic confines of a bundled payment system. So what does this mean for pricing in 2027 and beyond? Now, while we're still working on some of our post-TDAPA contracts, we know ESA price has decreased over time. And now incorporating a somewhat lower dose and dialysis compliance, we expect the average annual cost of therapy to fall somewhere between $1,000 and $1,500. Certainly not the price you would normally expect for a product bringing the level of innovation that Vapsio brings, but these are the dynamics of the dialysis market. If we can make Vapsio's standard of care, which means ultimately treating at least 200,000 to 250,000 patients, that would mean a potential multi-hundred million dollar peak revenue. So how are we going to get there? As I said, in Q4, even though we expect our customers to be conservative with inventory, we expect to continue to see an increase in patients. We expect Q4 patient growth will be driven primarily by our current mid-sized dialysis providers, USRC, IRC, and DCI. We share our shareholders' desire to see DaVita and Fresenius begin contributing to our revenue. And while we have a post-TDAPA contract with DaVita for 2027, at their request, We're working on a multi-year extension of that contract, and they've outlined their plans to begin rolling out the product slowly, which we expect to start this quarter, and in a much more significant way early next year. It's clearly been frustrating for us that adoption among the large dialysis providers has not progressed more quickly, but in the end, it's clinical evidence that changes the way prescribers think about patient care. Let me give you a few highlights from the voice data presented by Dr. Block at ASN. The trial enrolled 2,116 patients and met the predefined stopping criteria with a win odds of 1.16 and a p-value of 0.0016, establishing non-inferiority and superiority of the primary composite endpoint due to reduction in hospitalizations. The data demonstrated that hospitalizations were 10% lower in patients treated with Vatidustat versus ESA, without a significant difference in mortality rates. Exposure-adjusted serious adverse events were lower with Vatidustat, with 1.21.5 events per 100 patient years, compared to 1.34.2 events per 100 patient years for patients treated with ESAs. Given that SAEs generally drive hospitalization, this is not a surprising finding. As we've seen in the past, Vatidustat showed more stable hemoglobin control versus ESAs. In an exploratory endpoint, the data showed the odds of high hemoglobin excursions were reduced in patients treated with Vatidustat compared to ESA, while there was no overall difference in low excursions. There has never been an outcome study performed before VOICE that compared treatments for patients with anemia due to CKD that demonstrated an outcomes difference. And recall, like the voice primary endpoint, the post-hoc wind statistics analysis of our INNOVATE study also demonstrated a statistically significant lower risk of dying or being hospitalized for patients receiving Vata-Dustat versus ESAs. Now, the health economic analysis of the voice hospitalization benefit will be completed, but we presented an updated economic analysis from INNOVATE at the ASN. This analysis suggested that treatment with Vafsio resulted in a $6,200 lower annual cost of hospitalization per patient compared with ESA. And based on the assumptions used in the analysis, if all eligible dialysis patients with anemia were treated with Vafsio, it could result in more than 600,000 fewer hospital days versus ESA treatment. We have seen and know that adoption in nephrology, particularly dialysis, moves slowly, but this is the data that gives me the confidence to believe that Vapcio will ultimately become standard of care. This morning, we announced positive top-line results from the VOCAL study, which we conducted at the Vita Clinics. One more study demonstrating Vatidustat dose TIW is non-inferior to ESA in maintaining hemoglobin. We look forward to continuing the analysis of VOCAL to see what further differentiation we may be able to uncover. Now, ASN was also a great meeting when considering our rare kidney disease pipeline. A significant part of the meeting agenda was dedicated to advances in treating rare kidney diseases. We presented preclinical data that informed our confidence in prolissiglot for FSGS. As well as posters on our Phase II trial designs for both Ebrevifus and Prolisiglot. Additionally, Dr. Jim Tumlin presented to a full house in an exhibitor spotlight focusing on both Proli and Ebrevifus. I was pleased with the interest in both programs from the interactions the team had with investigators and potential investigators. As you know, both programs are enrolling their Phase II trials, probably in FSGS, and EBRI in a basket trial in C3G, IGAN, and lupus nephritis, with initial data from the EBRI trial expected in 2027. We're excited about the opportunity for both products, but particularly with EBRI, our tissue-targeted next-generation complement inhibitor. While data will obviously help define our strategy and development priorities, we believe Every's differentiated approach will allow for strong positioning with the potential for similar efficacy, a potentially better safety profile, and potentially less frequent dosing regimen versus current products in diseases like C3G. We believe there's tremendous value in our pipeline that is underappreciated or ignored in Akebe's value today. Now, let me turn it over to Eric to review our third quarter financial results.

Thanks, John. Total revenues decreased to $36.9 million in Q326 from $58.8 million in Q325. Turning to the components of these amounts, VASIO net product revenues increased to $14.8 million in Q326, as compared to $14.3 million in Q325, and Eryxia net product revenues decreased to $20 million in Q326, compared to $42.5 million in Q325. We continue to expect Eryxia revenues to decrease as compared to 2025 due to generic competition and pricing pressure. License collaboration and other revenues increased slightly to $2.1 million in Q3-26, as compared to $2 million in Q3-25. Turning to expenses, cost of goods sold was $6.4 million in Q3-26, compared to $9.4 million in Q3-25, driven by lower product revenues. R&D expenses increased to $16.2 million in Q326 from $14.9 million in Q325, driven by increased clinical trial activities related to our Phase II trials evaluating EBRI and PROBI. SG&A expenses decreased to $23.5 million in Q326 from $29.1 million in Q325, driven by lower marketing and headcount-related expenses. We generated a net loss of $14.4 million in Q326 versus net income of $0.5 million in Q325, driven by this quarter's lower revenues, which was partially offset by lower operating expenses, which included a $1.3 million restructuring charge incurred this quarter. Turning to the balance sheet, we remain in a strong financial position with $159.3 million in cash-in-cash equivalents at the end of the quarter, which includes $6.6 million in ATM proceeds raised early in the quarter. This compares to cash-in-cash equivalents of $155.5 million as of June 30, 2026. We believe our existing cash resources and the cash we expect to generate from product, royalty, supply, and license revenues, along with our plan to refinance our senior-secured term loan facility, will enable us to fund our current operating plan for at least the next two years. With that, we will now open the line for questions. Operator?

Operator

Certainly. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile our Q&A roster. Our first question will come from the line of Julian Harrison of BTIG. Your line is open.

Speaker 2

Hi, this is Andrew on for Julian. Thanks for taking our question. I'll hop to, you know, just, I know you talked a little bit about the status of DaVita and the uptake of Vafcio, but is there any more color you can provide on the potential ramp we could expect at that to the end of this year and in 2027? And then one on the pipeline, just any updates specifically on the enrollment in the Polis Aguad trial, along with the EBRI trial? Thank you.

Thanks, Andrew. So, as I mentioned, I mean, we think it's a really positive sign that while the Vita has a contract, a post-TDAPA contract for 27, that they requested that we extend that contract out a number of years. And, you know, to me, that suggests that they're expecting, you know, this product to be meaningful in their clinics. And, you know, again, You know, talking to folks from the VEDA at the ASN meeting, it really is the voice data. That outcomes data is really driving that interest. You know, they've kind of outlined how they see it rolling out. I think, you know, their preference is that those kinds of conversations stay confidential. I know, Nick, if you want to add any caller on our conversations there.

Nick Grund Other

Yeah, I mean, they've been really constructive conversations around the extension of their contract. You know, my opinion is you wouldn't want to do that unless you were going to make a larger step into VAPCO utilization. Locking up that price, ESA-like pricing for a longer period of time, allows you to do that because it creates certainty. And so that's been, I think, a positive signal overall. When we think about their role, again, we don't want to talk about anything specific, but their interest in voice and now with vocal coming through. Remember, vocal was versus Mercerra, where voice was versus Epigen. This gives them another piece of data for what that conversion may look like within their DeVita population because they're a Mercerra shop overall. And so I take the contract extension as positive. And, you know, certainly having plans for a role that they're sharing with us, I think, is positive as well.

And, I mean, You know, we've talked about the frustration, right? I mean, there's no question we're frustrated that things haven't moved faster. I think the word to use around the Vita is deliberate, right? They are very deliberate in the way they approach things, and the challenge of that for a company like Kiki is it takes them a long time to get going. The other side of that coin, you know, we hope and count on is that once they start going, they can influence things very quickly in their units, and, you know, it becomes very sticky. And our job is to make sure that they have a very good experience, you know, as they convert people to Vafsio in their units. And your second question, Andrew, was around enrollment in our rare kidney trials. Now, we haven't given any updates on timing for Lissaglot. You know, we are, again, we don't want to do that until we feel really confident in getting the trial enrolled. I mean, I think when you look at other trials in FSGS, I think we would be, we'd suggest that we're enrolling the trial at the same sort of pace. You know, that's what we would expect. But it's a competitive space, and we want to make sure, you know, we know exactly when we're going to have the data before we make that announcement. You know, Every, of course, is a basket trial label. We're super excited about, you know, what Every can deliver, and we know we'll be able to deliver data sooner out of that trial. But it's early days there. But I will say again, I mean, the... Seeing, you know, the sessions at ASN and having conversations with these kind of KMEs there, the differentiation that we can potentially bring with Ebre really is exciting to the community, and, you know, I think it can be a very, very meaningful product.

Speaker 2

Thank you for that really helpful call.

Operator

Thanks Andrew. And our next question will be coming from the line of Roger Song of Jefferies. Roger, your line is open.

Speaker 2

Hey, team. Good morning. This is Nabil on for Roger. Thanks for taking our questions. So, on the vocal data, you mentioned some additional data that you're expecting. What could we look at beyond the hemoglobin non-inferiority? What other data could we be expecting here? Do you have any comments on dose intensity, dose adjustment frequency, and vocal compared to voice? And then just another follow-up. Thank you. Actually, and then with all of this data, do you think we have enough evidence to pursue TIW on the label? Thank you.

Thanks, Nabeel. So, you know, Vocal, we've just presented top-line data, so, you know, there's... As you can appreciate, I'm sure, there's many other analyses to be done there, so, you know, including thinking about how that would inform a regulatory strategy around TIW. Steve, maybe, you know, some of the other, kind of the omics and things, talk about that a little bit.

Steven Burke Other

Sure. You know, this is Steve Burke, CMO. We have endpoints related to measures of hemoglobin stability, so high and low hemoglobin excursions, the need for red blood cell transfusion, rescue therapies. So we don't have that data yet. We also have some exploratory work going around red blood cell phenotyping. So, you know, are red blood cells made under the influence of FCO substantially different than those made under the influence of ESAs? Which would make sense there would be, given the different mechanism of action. So we're waiting on data around proteomics, metabolomics, lipidomics on the red blood cells. So that could be quite interesting.

Thanks, Steve. Nipil, did that capture what you were looking for on vocal?

Speaker 2

Yeah, no, that's very helpful. And then, you know, as we're thinking about DeVita also, you know, you've mentioned previously, like, is there a number on the overlap of, you know, nephrologists that are at some of the mid-DOs, and then how many of those overlap at DeVita? Again, you mentioned the adoption, again, in this specialty is a little bit more gradual, but again, these are real differentiators, so curious also on the overlap.

Totally agree. You have 20% in the midsize and virtually nothing in the large. The patients aren't different, right? But that's an important question.

Nick Grund Other

I'm sure Nick has a sense of that. Yeah, when you think about Vita and how they interact with large group practices around the U.S., they typically are partnering with large group practices in terms of rounding at their clinics, et cetera, et cetera. And that large group practice also does that with USRC, they do that with IRC, and they do that with Versinius. And so those physicians who are in those mid-size organizations are getting experience with Vafsio. The overlap with DaVita in particular is typically around kind of a third. If you add in Fresenius, it's over 50% overlap in those rounding physicians. And so certainly we hear from physicians who are using the product at USRC or IRC with some frustration about not being able to use it in other places, which bodes well. But, you know, importantly, they are getting the experience, so when they do have access to it, we're hoping that has a positive influence around how they treat patients with vaccine going forward.

And I think you made an important point that I didn't really make in the opening remarks, or maybe it probably wasn't as clear as it could be. In a post-TDAPA world, you know, today, there's always a prior auth, if you will, for does the patient have TDAPA reimbursement. Post it out. While the price is obviously very significantly lower, that exclusion no longer applies, right? I mean, every patient will be able to get it. So, you know, even in places where the physicians want to get it, but the hoops are too many to jump through, hopefully there are fewer hoops and they can move more quickly. You know, we really count on DaVita. It's kind of driving this at a number of centers, but that doesn't mean that physicians can't access it at other centers, and we would hope that we could start to see an increase. And, you know, Nick also referenced Fresenius. I didn't say anything about that. We met with the Fresenius team. Multiple people met with the Fresenius team at ASN as well. I would say they are compelled by the voice data also. You know, I don't want to give the impression that we're not doing everything we can to drive business at Fresenius also. And, you know, being in dialysis for a number of years, you know that it's kind of dominoes falling. I think as we get Vita moving more quickly, you know, Fresenius will have to move as well. Our frustration is that we feel like we've been saying that to you for a number of quarters, and we're anxious to see this move also. We feel much more... I'm convinced that there's a real desire to move at this point, but in a very deliberate way.

Speaker 2

Thank you. Thank you for the call. It's very clear clinicians are appreciating the data and, you know, look forward to seeing the upcoming quarters. I guess maybe one small, tiny question. On those missed dialysis sessions, you were mentioning just kind of the lower compliance. Do we have any data on any impact on hemoglobin control, or are those patients more likely to have, you know, a need for ESA rescue, or any thoughts there? And that's my last question, thank you.

I don't think we have, we really have data on that. I mean, this is... You know, if you look at the USRDS data, you know, it suggests that... There are generally 13 dialysis sessions in a month if a patient showed up for every session. And the average is about 10.8. We've seen just slightly less than that. I mean, I think the expectation, I think most providers feel like they do better and that patients are there more like 12 times. And again, that could be a hospitalization that they're not there for or they just simply miss it or the like. But it's not 12. It is something closer to 10, somewhere between 10 and a half and 11. Now, if you think about it, Nabil, if you show up, you know, 10 to 11 times and you get your Vasio every time, you know, you're still talking about 80-plus percent compliance. That is generally better than what patients have when you send the product home with them. And, you know, we usually model something like two-thirds, you know, that they take about two-thirds of their pill. You're still getting more of a dose, I think, in TIW, with TIW dosing, but it's just less than, you know, the expectation, and that drove that inventory shift. Great. Thank you for the clarity.

Speaker 2

Thank you for taking my questions. Thanks so much, Demille. Appreciate it.

Operator

And our next question will be coming from the line of Matthew Caulfield of H.C. Wainwright & Company. Your line's open.

Speaker 2

Hi, John and team. Thank you. In terms of the noted slower-than-expected uptake from the major DOs, specifically, what do you see as the greatest barriers to broader utilization from the large DOs during post-TDAPA into 2027?

So, you know, again, I mean, I think if you look at them separately, you know, DaVita, you know, is now looking at the product much more seriously and putting a very clear process in place. I think that it's incumbent upon us to make sure that, you know, kind of help educate physicians, do what we can to make sure their experience is... It's a good one. It's different switching someone from Myrcera to Vasio than switching someone from epigen to Myrcera, right? I mean, that has complexity to it. This has more. So, you know, we've seen that. And, you know, the great thing about kind of where we are today is a DaVita is going to learn a lot from what was experienced at USRC, IRC, DCI. Jeff Block is an amazing advocate for this product. And because he believes in the outcomes benefit for patients, you know, we know that there was a medical directors meeting that they have every year at the ASN, where all the medical directors across the dialysis providers meet, and Jeff presented the voice data to them and took their questions, right? So I think them understanding that, so you understand the benefit, but then you've got to operationalize it. And making sure that that operational process goes well, you know, is important. And so I kind of referenced what we're hearing from USRC, IRC, DCI, is the physicians are doing different things, which is fine, but, you know, at the end of the day, you just want to make sure that they're having a good experience. So we're quite, you know, feeling confident about the Vita, but again, it's not an overnight They're going to go in a deliberate way through the organization to get an experience level with that. Fresenius is going to take longer. They were clearly interested in the data. They got the potential benefit here for their patients. But they're, you know, they are a different organization. They have a relatively new CMO there. They have a brand new CEO. They are, like, organizationally, you know, they're in a little more flux than a place like DaVita. So, you know, we're continuing to work there. We have a very good relationship with the folks at Fresenius. But I certainly don't want to leave the impression that we're ignoring Fresenius. We are not. We do believe that you don't get the standard of care until they start to move as well. We just know that they're going to take longer to move.

Speaker 2

Understood. I appreciate it. Thank you for the caller.

Operator

Thanks, Matt. Our next question will be coming from the line of Allison Bratzel of Piper Sandler. Your line is open.

Speaker 2

Hi there. This is Peter on for Allison. Thank you for taking the question. You recently dosed the first patient in your Phase II basket trial in rare kidney diseases with initial data next year. What initial data can we expect, and what findings will be most important in determining the next steps for the program? Thank you.

Steve, do you want to go?

Steven Burke Other

Sure. Hi, it's Steve Burke again. We're principally looking at decreases in urine protein creatinine ratios. We're also measuring, you know, complement biomarkers in the blood and urine. We hope to show a substantial reduction in urine protein and do so without an inhibition of the complement system in the blood, and that's a very important differentiator for us versus other complement inhibitors.

Let me just kind of underline that. You're going to be looking for impact on proteinuria and impact on what's the Weiss Lab test, the alternative pathway in the blood, right? We're impacting the disease at the site, the kidney, without impacting the alternative pathway in the blood. Pretty straightforward. Hopefully, we'll be quite clear.

Operator

Thank you. And our next question will be coming from the line of Ed Art of West Park Capital. Your line is open.

Ed Art Analyst — WestPark Capital

Great. Thank you. Thanks for taking my questions. A couple from me. So, first, on the quarterly results, I think you mentioned it earlier in some of your prepared remarks, but I think I missed it. Just the amount of the underlying growth in the quarter, given, you know, the discontinuity between the sales and underlying growth. Um, secondly, um, You know, you've talked about the beta and Fresenius, but I was curious about the vocal results and how you see that fitting in the near term, the impact of those results, specifically with, you know, CMOs at the various dialysis organizations and ultimately payers and how they would view that data. And then finally, if I could, the reduction in the price that you mentioned, just wanted to get a better sense, if you could, on the two drivers of the lower average doves and the lower compliance. I know you mentioned some of that. I just wanted to get a better sense for what the changes were relative to what you thought previously. Thanks so much.

Thanks, Ed, and welcome back to the call. It's good to have you back. So on the quarterly result, as I mentioned in my remarks, the third quarter, the underlying demand, patient demand, was somewhere between $19 and $20 million. So if you think about it, we did just about $15 million in revenue. You took out somewhere between $4 and $5 million of inventory from the channel. And you think we did $21-ish million last quarter, and it was between $17 and $18 million last quarter. So you could see that that was just a shift of inventory from one quarter to the next. Now, the vocal results, again, we only have top-line results. I think Steve referenced earlier and is answering the question. There's a lot of really interesting science that I think will make for, I hope, will make for some interesting kind of additional, you know, what you always try to do is like, what are the differences? Why is this managing anemia with a HIF different than managing anemia with an ESA? You know, and, you know, we've shown this outcomes difference now. You kind of want to continue to show why. You know, why are you seeing an outcomes difference? Because there are these differences in the way that a HIF drug behaves versus. versus an ESA. I think we're in a totality of the data situation, right? And you look at a DaVita, it's the outcomes data that's driving them, but they look at every piece of data. And this is just another consistent study where we demonstrated that the drug is able to manage hemoglobin effectively. And you have all these other kind of interesting analyses that may yield some further differentiation. I mean, you know, we've already... Published data, a data that's been published that shows differences in lifespan and size of hemoglobin. I mean, you know, there's already differences that have been demonstrated in managing with a HIF, but this is, you just want to continue to build that evidence base for why it's a good thing and why it's not a fluke that in two studies we've seen this difference in outcome. Now, you mentioned payers. For better or worse, payers aren't really an important market for us to consider because Vastia was now part of the dialysis bundle, so it is up to the dialysis provider to decide. What product, and the physicians, of course, to decide what product they're going to use, the payers don't have much of say. Even when you're outside of Medicare in commercial or Medicaid, these are still generally paid on a bundled rate. So payers don't really have much of a say or care much what folks use. And then the reduction in price. I mean, we had seen that... ESA prices were starting to drop. I think that's the bigger driver than anything else, Nick, but maybe you want to comment on that?

Nick Grund Other

Yeah, you know. Let's start with EPO. You know, EPO had been putting pricing pressure into the market over the last, let's call it, 18 months, so their prices were coming down. But frankly, DaVita is Mercera, Fresenius is Mercera, IRC is Mercera, and where EPO is really predominant is within USRC. But frankly, the advocacy within USRC for Vasio and it being in a SIDAP period, we were somewhat immune to that EPO pricing decrease. That continues to drop as they continue to try and gain share through pricing because, you know, at some price point, DOs view all ESAs as interchangeable, right? And so you look at that interchangeable, and recently, Mercerra has started to reduce their price, and that has a bigger impact. And so when we say we're ESA-like pricing, the DOs are all... Really good at their jobs and listening to us, and as Mercero comes down, they're also putting pressure on Basio price. The other thing that's going on is, as we've kind of said all along, is as volume increases, prices come down, and that's what we're seeing here, certainly this current year. The important part about all this kind of pricing pieces is in an environment where you're priced similarly and you have data like voice. That shows a clear differentiation in hospitalization, which has a large economic impact for the DOs. That becomes a really interesting data point as they think about which products they want to put on protocol and want to really encourage their physician base to use.

Yeah, you know, I mean, they have this opportunity with these value-based care contracts that reducing hospitalization could yield a huge benefit for them. But the purchasing people just care about the price of acquisition, right? And this is a dialysis. It's just a different market. You don't have the same kind of leveraging contracting you do in other markets. And, you know, we kind of referenced that the dose was about 10% lower than average. You know, we incorporate that in. It's a little bit more than that, you know, when you look at dialysis compliance. Between those, you're probably talking somewhere between 25% and 30% reduction, and then the EPO price reduction kind of leads us into that $1,000 to $1,500 price range that we think is just easier for you all to understand that's where the market is today.

Ed Art Analyst — WestPark Capital

Great. Thank you both, John and Nick. Thanks for that. That's helpful. Appreciate it.

Thanks, Ed. Again, welcome back.

Ed Art Analyst — WestPark Capital

Thank you.

Operator

And our next question will come from the line of Rowana Ruiz of Lee Rink. Your line is open.

Speaker 2

Hi, guys. Good morning. This is Anna on for Rwana. Thanks so much for taking our question. Just to dig a little deeper into EBRI, just curious, what differences are you looking for in the metrics you mentioned earlier to potentially differentiate between the basket of indications that you're studying? Thanks.

Steven Burke Other

Sure. Just to reiterate, maybe a little background. Every is a fusion protein that recognizes C3D in the surface of cells, and on the back end there are two factor H moieties, which are negative regulatory elements in the complement system. So what it's doing is targeting the factor H to the sites of complement activation, and therefore we feel we'll have... A potential to have superior complement inhibition, but without inhibiting the complement system systemically, specifically, as John mentioned, via alternative pathway, which is measured by a Weiss lab assay. So we're looking for, you know, excellent reduction in proteinuria across all the conditions. So, C3G, that's very important. Again, very important. Lupus is a little more complicated because you need to show reduction in proteinuria and stabilization of kidney function, so the estimated GFR. But in all cases, it's reduction in proteinuria, stabilization of the kidney function without inhibiting the alternative pathway in the blood because inhibiting that pathway puts you at risk for serious bacterial infections. And so there's a box warning for most products, and you need to vaccinate the patients if you can't vaccinate them. Soon enough, you have to put them on prophylactic antibiotics. So that's the major point of differentiation. Right now, we're giving the drug once a week subcutaneously. That may be the frequency going forward. It could be less frequent. We need to do more work in that regard. So I hope that answers your question.

Speaker 2

Yeah, super helpful. Thank you.

Operator

Thanks, Anne. I would now like to turn the conference back to John Butler for closing remarks.

Thanks, Operator, and thanks to all of you for your questions and for joining today. The past few months have provided many opportunities to speak directly with providers, prescribers, trialists, and patient advocates at ASN Kidney Week and other meetings and events. I always walk away feeling optimistic and encouraged that so many people share our commitment to improve the lives of people impacted by kidney disease. A standout among them is Nick Grunt. Nick joined the Kibia to guide the Vafsio launch and has worked tirelessly to get Vafsio to patients. He navigated the complex Tdappa landscape, built out a sales organization, and prepared the team for our post-Tdappa launch. While he's resigned his position as Chief Commercial Officer, we're fortunate to have Nick on board in a consulting capacity as we work to finalize Vafcio contract extensions into next year and seek to increase adoption, especially at the large dialysis organizations. I want to personally thank him for his dedication to Akebia and our patients. We remain committed to our goal to make Vafcio a standard of care and to advance our kidney disease pipeline. I look forward to updating you all on that progress. Thanks, everyone. Have a great day.

Operator

This concludes today's conference. Thank you for your participation. You may now disconnect.

Analyst Q&A · 1 question
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