Akebia Therapeutics Inc (AKBA) 2025 Q4 法說會逐字稿

Good day, and thank you for standing by. Welcome to Akebia's fourth-quarter 2025 financial results conference call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Mercedes Carrasco, Senior Director of IR. Please go ahead.

Thank you, and welcome to Akebia's fourth-quarter and full-year 2025 financial results and business update conference call. Please note that a press release was issued earlier today, Thursday, February 26, detailing our fourth-quarter and full-year 2025 financial results, and that release is available on the Investors section of our website. For your convenience, a replay of today's call will be available on our website after we conclude.

Joining me for today's call, we have John Butler, Chief Executive Officer; Nick Grund, Chief Commercial Officer; and Erik Ostrowski, Chief Financial and Chief Business Officer. Dr. Steven Burke, our Chief Medical Officer and Head of Research and Development, is available for Q&A dialing in from the Annual Dialysis Conference in Kansas City today, where Akebia will present data on Vafseo this weekend.

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 February 26 as well in the Risk Factors and Management Discussion and Analysis section of our most recent annual report filed with the SEC.

With that, I'd like to introduce our CEO, John Butler.

Thanks, Mercedes, and thanks to all of you for joining us this morning. 2025 was an important year for Akebia, marked by the commercial launch of Vafseo, vadadustat, our oral HIF-PH inhibitor for the treatment of anemia due to chronic kidney disease for patients on dialysis. Vafseo, along with our phosphate binder Auryxia, generated $227 million in net product revenue in 2025, during which time we also progressed multiple post-marketing clinical trials and advanced and enhanced our growing pipeline.

Let's start with Vafseo. 2025 got off to a very fast start before a number of challenges flattened demand in the second half of the year. We addressed those challenges head on, and we believe today, we're starting to see the demand growth that we've expected. Most importantly, the body of evidence is growing that supports the potential for Vafseo to become standard of care in what is a $1 billion US market opportunity after the TDAPA period ends when we expect Vafseo will be priced roughly in parity with ESA pricing.

While we didn't see the growth we expected in the second half of 2025, we built real excitement for Vafseo. Today, just over a year into the launch, more than 1,000 prescribers at 24 different dialysis organizations have written a prescription for Vafseo and 290,000 patients have access to Vafseo in dialysis clinics with a protocol in place.

I'm particularly encouraged by the shifting dynamics we began to see in Q4 that are continuing in Q1 that suggest greater breadth of prescribers as well as improving adherence rates. Nick will provide more detail on these very encouraging trends in his remarks.

Now a key element of our strategy to have Vafseo become standard of care includes continuing to generate data, supporting the benefits of managing anemia with a more physiologic approach compared to ESAs. At the ASN meeting in November, we presented a post-hoc hierarchical composite endpoint analysis of prospectively collected outcomes of death and hospitalization from our Phase 3 INNO2VATE program in dialysis. This analysis demonstrated that patients treated with Vafseo experienced a lower risk of dying or being hospitalized than patients treated with the ESA comparator.

This coming weekend at the ADC in Kansas City, we're presenting a cost comparison of Vafseo versus darbepoetin based on INNO2VATE data. In this analysis, Vafseo showed a 7.7% lower annual hospitalization rate, 16% reduction in hospitalization days, and based on Medicare cost data, approximately 15% lower Medicare hospitalization costs for patients treated with Vafseo versus darbepoetin.

Reduced hospitalization translated into a cost savings of about $3,700 per patient per year, meaning a savings of almost $2 billion per year if all eligible patients were treated with Vafseo. These results are meaningful for dialysis providers, Medicare and other payers and, most importantly, for patients.

Late this year, we'll have the results from the VOCAL study that we're conducting at DaVita clinics that's evaluating Vafseo's dose three times weekly. The trial also contains a substudy of red blood cell characteristics, which we believe could make a compelling argument for Vafseo. Fundamentally, when you manage hemoglobin levels with a more physiologic approach, you get a more physiologic and potentially better functioning red blood cell.

The VOCAL data will be followed by results from the VOICE trial being run by USRC, evaluating Vafseo versus standard of care on a hierarchical composite of all-cause mortality and hospitalization rates, data expected in early 2027. In my experience, in order to make a drug standard of care, particularly with nephrologists, you have to continue to deliver data that demonstrates the benefit of the product for their patients versus current treatment.

Now in addition to the launch of Vafseo in 2025, we introduced our rare kidney disease pipeline, which we believe will be an additional and important value driver for the company going forward. Strategically, this initiative is a natural extension for us as it leverages our expertise in kidney disease drug development, broadens our presence within the kidney disease community, and fits squarely within our corporate mission.

We will host an R&D Day for investors on April 2 to discuss our mid-stage assets in detail, namely praliciguat and AKB-097 as well as introduce our early HIF-PHI AKB-9090. Praliciguat is an oral once-daily soluble guanylate cyclase stimulator being evaluated in a Phase 2 clinical trial of focal segmental glomerulosclerosis or FSGS.

We expect to enroll up to approximately 60 patients in this trial, which will evaluate change from baseline in urine protein to creatinine ratio, or UPCR, at 24 weeks as the primary endpoint. Both the extensive preclinical work in FSGS disease models as well as previous clinical results for praliciguat in diabetic kidney disease give us confidence in the potential for the therapy to impact FSGS.

AKB-097 is our tissue-targeted complement inhibitor that we acquired late last year. We believe this product candidate could have comparable efficacy to the most efficacious currently approved products in a well-characterized pathway. While the tissue targeting allows for the potential to: first, avoid the box warning for infection risk; and second, to deliver the drug in a more convenient dosing regimen.

We believe this has best-in-class potential. We plan to initiate a Phase 2 open-label basket trial in the second half of this year. We will be looking at initial indications of IgA nephropathy, lupus nephritis, and C3 glomerulopathy. These diseases represent a multibillion-dollar market opportunity in areas of high unmet need.

As part of the basket study, we'll be evaluating safety, tolerability, pharmacokinetics, pharmacodynamics, and effects on disease-relevant biomarkers such as proteinuria and kidney function. As this is an open-label basket study, we expect to begin to report initial data in 2027.

And lastly, we plan to initiate a Phase 1 study in healthy volunteers of AKB-9090 in the first half of 2026 with top-line results later this year. Our initial target disease area for 9090 is acute kidney injury associated with cardiac surgery. Our research and development team is working hard to deliver these important catalysts as quickly as possible. But of course, all of this work will be built on the success of Vafseo.

Now let me turn it over to Nick to give more granularity on the launch.

Thanks, John. Good morning, folks. Like John, I'm encouraged by the growth potential for Vafseo in 2026, which is supported by early Q1 data. But first, let me recap the quarter four 2025. During the quarter, approximately 800 prescribers wrote a prescription for Vafseo, and each prescriber on average wrote approximately 10.3 prescriptions. Of note, 128 of those were new prescribers.

During quarter four, we were pleased to see our customer base expand and the number of new starts at dialysis organizations outside of USRC, specifically at DaVita and IRC, increased over Q3. Approximately 25% of new patients came from dialysis organizations other than USRC during the fourth quarter.

That said, Vafseo demand in quarter four was slightly down versus quarter three as we reported $6.2 million in Vafseo net product revenue on about $11 million in demand. We believe the slight decrease in demand, specifically in quarter four, was primarily a result of a lower number of patient starts at dialysis organizations deciding to transition to an observed in-center dosing protocol and thereby waiting until the observed dosing protocol was available.

USRC, for example, began to transition in November in approximately 25% of clinics. By the end of Q1, we expect the vast majority of USRC in-center patients to be receiving Vafseo three times a week while receiving dialysis utilizing USRC's observed dosing protocol. Of note, USRC's decision to transition to an in-center observed dosing protocol did result in a reduction in their inventory as they shifted from shipping a bottle to a patient's home to stocking bottles at their centers. The distribution change resulted in a one-time inventory drawdown impact of about $4.8 million in the fourth quarter of 2025.

Now let's turn to 2026. We begin the year on an optimistic note as we are already building momentum. At present, 290,000 patients have prescribing access as DCI has implemented a Vafseo protocol. With the almost fivefold increase in prescriber access since the end of Q3 2025 and our field teams actively calling on physicians with expanded access, we are seeing an expansion of brand awareness and a comfort prescribing Vafseo within the nephrology community.

Additional commercial trends give us confidence in quarter one and the year ahead. First, we saw improved adherence from the beginning of 2025 through the end of the year and continuing into 2026. More importantly, the percentage of patients who got an initial refill rose from approximately 75% for all daily dosing patients in the first nine months of 2025 to approximately 91% among the small subset of patients who were on observed dosing regimen.

Looking at early patient data from January, we've continued to see an improvement in first refill adherence with approximately 87% among the now larger subset of patients on an observed dosing regimen. We're encouraged by this improvement, and we'll continue to monitor adherence rates in 2026 as centers implement their observed dosing protocols.

Second, we are also seeing a nice pickup in utilization and broader adoption from IRC, the fourth largest dialysis center, after IRC made Vafseo available in late August and implemented an observed dosing protocol late in quarter four. In addition, ECI has started to put patients on therapy. We also see the number of prescribers within DaVita starting to increase with some physicians trialing Vafseo in their patients. This has led to a higher percentage of new patients being from non-USRC clinics than in 2025.

The investment dialysis organizations continue to making Vafseo, taking the time and effort to integrate the therapy into protocols and care plans make me believe that providers and prescribers understand the clinical benefit Vafseo can deliver and are committed to using it long term. As prescribers continue to gain real-world experience as they transition patients on to Vafseo, I expect the momentum to continue to build. Our dedicated sales team is focused on increasing the breadth and depth of prescribing, a critical step to becoming standard of care for patients on dialysis.

Let me now turn it over to Erik.

Thanks, Nick. As John mentioned, we saw strong top-line performance in calendar year '25 as net product revenues increased nearly 50% over calendar year '24, driven by the US introduction of Vafseo and increased sales of Auryxia. Our continued careful expense management in 2025 allowed us to both invest in R&D initiatives we believe can generate significant shareholder value and maintain our solid financial position. We are excited for a strong 2026 and executing on our plans to grow Vafseo revenues and advance our pipeline, including our mid-stage rare kidney disease programs.

I'll now provide an overview of our Q4 '25 and calendar year '25 financial results as compared to the prior year. Total revenues were $57.6 million in Q4 '25 compared to $46.5 million in Q4 '24 and $236.2 million in calendar year '25 compared to $160.2 million in calendar year '24. These increases were driven by sales of Vafseo and an increase in Auryxia sales.

Vafseo net product revenues were $6.2 million in Q4 '25 and $45.8 million in calendar year '25. As Nick mentioned, Q4 Vafseo sales were negatively impacted by the inventory drawdown at USRC. Auryxia net product revenues were $48.1 million in Q4 '25 compared to $44.4 million in Q4 '24 and $181.5 million in calendar year '25 compared to $152.2 million in calendar year '24. We note that we anticipate generic competition for Auryxia to expand this year beyond the current authorized generic competition and therefore, expect Auryxia revenues to decrease in 2026 as compared to 2025 Auryxia revenues.

Turning to expenses. Cost of goods sold was $12.5 million in Q4 '25 compared to $20.4 million in Q4 '24 and $39.5 million in calendar year '25 compared to $63.2 million in calendar year '24. COGS in both periods was driven by higher Auryxia sales volumes in 2025 and was impacted by the elimination in 2025 of a quarterly $9 million non-cash intangible amortization charge we incurred through Q4 of 2024.

In addition, COGS for calendar year '24 included a $12.3 million benefit due to our ability to sell inventory previously written down as excess inventory. Of note, Vafseo-related COGS in both periods of 2025 was derived from pre-launch inventory, which does not include the full cost of manufacturing as a portion of those inventory-related expenses were recorded as R&D expenses in the period incurred prior to Vafseo's approval in the US.

R&D expenses were $26.6 million in Q4 '25 compared to $11.8 million in Q4 '24 and $62.4 million in calendar year '25 compared to $37.7 million in calendar year '24. The increase in expenses in both periods was driven by increased clinical trial-related activities for Vafseo and our other product candidates, higher headcount-related costs, as well as by a $12.8 million charge incurred during Q4 '25 related to acquired in-process R&D costs associated with the acquisition of AKB-097.

SG&A expenses were $26.1 million in Q4 '25 compared to $27.7 million in Q4 '24 and $107.5 million in calendar year '25 compared to $106.5 million in calendar year '24. Net loss in Q4 '25 decreased to $12.2 million as compared to a net loss of $22.8 million in Q4 '24. Net loss for the year also decreased to $5.3 million in calendar year '25 as compared to a net loss of $69.4 million in calendar year '24. The decrease in net loss in both periods was driven by the increase in net product revenues, which was partially offset by higher expenses.

Turning to the balance sheet. Cash and cash equivalents as of December 31, 2025, were $184.8 million as compared to $51.9 million as of December 31, 2024. We believe our existing cash resources and cash from operations will be sufficient to fund our current operating plans for at least the next two years.

With that, we welcome questions.

(Operator Instructions) Julian Harrison, BTIG.

I have a few, and I'll just go one by one here. First, can you talk more about your expectations for sequential Vafseo growth in 2026? Wondering also how we should be thinking about that in relation to your inventory adjusted demand in the fourth quarter of 2025?

Second, to what extent do you expect data from the VOICE study to potentially accelerate uptake next year across dialysis providers?

And then finally, I'm curious how operationalized the Vafseo access at DaVita currently is? Are the VOCAL data a big gating step there? Or do you expect broad commercial uptake at DaVita before the VOCAL data are reported?

Great. That's a great list, Julian. Thanks. So expectations for growth first in Vafseo. So we're not guiding for revenue. So I'll start with that. I mean I think it's -- again, when you're in a launch, particularly in this dialysis market, as you saw last year, we certainly -- I certainly expected, A, that dialysis providers would latch on to the opportunities around TDAPA more quickly, and we certainly didn't anticipate the issues we had with adherence, but we're certainly dealing with those, as I said, very much head on.

But I think the way to think about it is, forget the inventory fluctuations. We give you the demand number and really think about that, right? I mean demand basically has been flat. We had $12 million in the third quarter, $11 million in the fourth quarter, and it was actually $12 million in the second quarter as well, right? So we absolutely expect and are seeing growth from that level.

We don't know exactly how quickly that will increase. I think people are looking for this magical hockey stick. And when I think about launches that I've been a part of in this market that didn't have the complexity of the dialysis provider in between, I mean I go way back in time to sevelamer or Renagel launch, we did $20 million in the first year, $55 million in the second year, $130 million or something in the third year. Ultimately, it was a $1.3 billion product, right?

But nephrologists don't adopt products like oncologists, right? And you definitely have a more measured growth. And I think that's what we're seeing here as well, particularly, I think as you look at DaVita, where DaVita has made the product available but aren't sending out lists to physicians of patients that have reimbursement. They're leaving it to the physician to make the decision. That's fine. That's on our field teams to sell and educate physicians about the benefits.

And it's things like the data from VOICE. So you look at the data from the ASN meeting last year, it's super important data, right? We'll make a huge impact, but it's not published yet, right? So it's been submitted for publication. It's just been presented at ASN.

Our medical affairs folks can't educate physicians with that data until there's a reprint in publication, peer-reviewed, which we expect is going to happen this year. But then the same thing will be the case with the cost analysis that's being presented this weekend. We have to get those things published.

And I think you'll see the same with VOICE and VOCAL as well. As these things are published available and our sales and medical affairs folks can use them, these are the things that influence utilization and physicians. And I've never been more confident that the data that we're generating supports that managing anemia with a HIF-PHI and the only one that's available is Vafseo is going to be standard of care for this patient population.

It really is just a question of how quickly that happens. And we're seeing growth now. We're confident in that growth, but we're not in a place where we want to guide around that. We want to see it continue to move in the direction that it's moving now.

And maybe, Nick, you can talk more about operationalizing at DaVita?

Yeah. And so certainly, DaVita made the product widely available throughout their, quote-unquote, village in late Q4. And as they've started to focus on educating their physicians, they're really starting with the home dialysis population.

That population within DaVita is greater than 30,000 patients. So just about the size of USRC. And so that's a great step. It really fits with USRC in total. It really fits well within the profile of Vafseo. So super excited about that.

Second, they're also really contemplating an observed dosing protocol, which will certainly hopefully handle some of the adherence challenges that we've seen in the past. And so -- but DaVita is not going to, as John suggested, send out lists and compel physicians to try it. It's our field teams, whether that be medical, educating them about Vafseo or sales selling Vaio that are really going to help physicians try and then increase usage and then ultimately adopt Vafseo as a standard of care.

And so when we think about that process, DaVita is a fairly big organization, getting them to try, and we're very encouraged. In the quarter four, we saw a number of DaVita physicians starting to utilize Vafseo, and that's continued into quarter one. And so as John suggested, we're not going to see this hockey stick inflection. It is going to be steady growth month-over-month, quarter-over-quarter as we start to penetrate deeper in terms of breadth and depth.

I mean it definitely depends on how you define a hockey stick, right? Three quarters of flat sales, it will be -- you will have growth. So that's -- you can call that a hockey stick. We do expect that to continue to grow. It really is about what's the slope of that curve, right? And again, I think as I said, one of the things that surprised me most was that it didn't happen faster because of the economic benefits of using the drug during TDAPA.

But at the end of the day, it was always about the clinical benefit. And that's what we're showing now. And Nick talked about the observed dosing protocols that are being put in place. We really do think by the end of the year, most patients who are being treated in center are going to be treated with that observed dosing and that observed dosing means they get it three times a week when they're sitting in the chair.

That helps greatly with compliance. And the anecdotes that we're hearing from physicians that have begun utilizing three times weekly dosing are -- and more importantly, maybe the anemia managers that are managing those patients on a daily basis, they're really very, very positive. So we're really excited that DaVita is moving forward with that as well. And if they focus in the first part of the year on their home population, that will be fantastic for us from a growth perspective. Hopefully, that helps, Julian.

Roger Song, Jefferies.

Congrats on the progress. This is Nabeel on for Roger. It's encouraging to hear about the improvement in the first refill adherence. I was curious if you could comment on how second and third refill rates are trending. And then any other comments just on the anemia manager education? And then I have a second one.

Nick, do you want to take that one?

Yeah. And so super -- let's repeat the first refill because I think it is significant. So historically, we've seen roughly a 75% adherence on the first refill. So a patient receives an initial prescription, that first refill is the next prescription. And so that moving from 75% to 91% in the fourth quarter in that small subset of patients was really an important, I'll call it, bellwether for what we're going to see moving on.

We were waiting for the bigger subset in quarter one and specifically in January to say, okay, now is it really coming to fruition in a larger patient population? And it is. We're seeing this 87% first refill rate. As they moved into the second prescription, I think your question is a really good one. We've seen a significant continuation of that adherence rate.

And so you have to remember, these patients have significant comorbidities, co-mortality, they receive transplant. There's always an underlying, let's call it, 2% to 4% discontinuation rate in that population every single month. And so we've seen this continuation of this high 80%, 90% adherence rate even through the second prescription is starting to lead towards some positive trends for annual adherence rates.

And the other thing you're going to see, as the clinical data continues to build, even if a patient -- one of the main reasons that a patient would go off is if they feel like they have some GI tolerability issues. But we know those are transient, right?

And what we've seen from physicians who really believe in the clinical benefit, they talk to the patient and say, I understand what you're dealing with, but we put you on this medicine for a reason. We really believe this is going to benefit you. I want you to try to work through it and it will go away, and it does.

And then there's other physicians or nurse managers who aren't as sold on the drug, maybe it's a way to say it or don't have the same level of education on the product benefits. And they'll acquiescent and take the patient off, right? So Nick, do you want to add something?

Yeah. The only thing I'd probably add is by people moving from daily dosing to observed therapy in the clinic, what we've seen is a number of restarts of patients, patients coming back in. That means that physicians are saying, hey, that patient who may not have been compliant the first time around by being able to give it to them in the chair, we now can go back to that patient because we believe in the value that Vafseo might bring and by being able to dose it in the clinic three times a week has allowed them to offset that compliance challenge and really provide Vafseo for that patient.

Nabeel, you had a question. I'm sorry, I didn't write it down. I can't remember what it is.

Yeah. Just on the 9090 asset, again, congrats on the progress here. Just curious how that's -- if you can comment a little bit more on how that's mechanistically differentiated from prior SPHs? And then any other thoughts there?

On 9090, Steve, you want -- can you take that one?

The molecule has a different pharmacokinetics and a slightly different profile. Vadadustat tends to preferentially target the liver. That's where the erythropoietin is made, whereas 9090, because of its structural differences, has more widespread tissue penetration, so it gets into the lung and the kidney.

And in our non-clinical models of ischemia reperfusion injury, 9090 was clearly the best compound that we had for that indication, whereas vadadustat probably would not work in that indication. So it's all about the structure and the PK.

Nabeel, I think your other question was around anemia manager education. And I think it's maybe important to point out, we definitely recognize how significant that is. And a lot of that education has to be done through the medical affairs folks, our MSLs.

We made the decision earlier this year to expand our medical affairs group, so that we have more folks feet on the ground, if you will, doing that education. So much of this data that's coming out really needs to be delivered, whether it's to a physician, KME, or an anemia manager through the medical function rather than the sales function. So we're still finalizing the last couple of positions there, but those folks have hit the ground running and really ramping up our education.

Nick, do you want to add something?

It's great to see that the dialysis organizations are actually participating in that education, right? So USRC, we've had great advocacy from Dr. Dittrich and Dr. Block all along, and they've been educating proactively. Within DaVita, they have a centralized anemia management model. So those folks aren't necessarily in the clinic, and they've been educating their centralized anemia managers themselves, which also is a great step for getting folks comfortable with Vafseo.

Roanna Ruiz, Leerink Partners.

This is Michael on for Roanna Ruiz at Leerink Partners. For VOCAL study, can you give us a sense of what success looks like? Is this primarily about demonstrating TIW non-inferiority versus ESAs? Or are you powering for superiority on any endpoint? And also, how important is the RBC sub-study in differentiating Vafseo's mechanism?

Steve, do you want to take that one?

Sure. Yeah. No, you're right about the study. It's 350 patients. DaVita felt it was important for them to do the study in their own units, partly to operationalize it, but also establish that the drug is as safe and effective as the ESAs, Mircera that they're using today.

I suspect we'll see superiority on some of the hemoglobin-related safety endpoints, which we saw in the FOCUS study. So less rapid rises, less high hemoglobins and less need for dose adjustments. But it's not -- that's all prespecified, but it's not like it's a primary endpoint. The primary endpoint is non-inferiority for hemoglobin control, which makes sense because you're targeting people to a range of hemoglobin (technical difficulty)

I do think the red blood cell study will be interesting and important because I think there may be some -- people who aren't really as close to this don't understand how different Vafseo is from ESAs, where ESAs, you're basically giving a recombinant human EPO, it binds to receptor on cells in the bone marrow and helps them differentiate into red blood cells.

But Vafseo does so many more things. And we already know that the red blood cells that are made under the influence of Vafseo are different. They're bigger. They have more hemoglobin. They have a more uniform distribution of width. So this additional information, I think, will build on what we know to be true today that the red blood cells really are different.

So I think it gives physicians a reason to believe that Vafseo is different. And then when we have data around things like death and hospitalization, it makes more sense to them. There's a mechanism by which they can understand these clinical benefits.

Got it. Another question, if I may. Have you reactivated the IND for AKB-097 yet? And are there any changes you made to the protocol from Q32 that was previously aligned with FDA?

That's a great question. We have been reworking the protocol just to make it simpler. But fundamentally, it's the same protocol that FDA agreed to with Q32. We're just trying to make it less operationally complex so that it's easier to recruit and easier to run. And we won't activate that IND until we resubmit the protocol that we're very close to finalizing. So I hope that answered your question.

Allison Bratzel, Piper Sandler.

This is Ashley on for Allison Bratzel of Piper Sandler. Just one question from us because you guys did a great job of answering our other questions. But just on the R&D Day on April 2, when you're discussing your pipeline, can you help frame some expectations for investors? What should investors look forward to? What level of detail are you planning to provide? Any color there would be super helpful.

Sure, Ashley. So obviously, we're still bringing together the agenda for that. As I said, I mean, we really will focus -- there's so much that we could talk about. And that's the exciting thing for the company right now. There are so many areas we can go. But I think we really want to focus on praliciguat and 097.

And we think it's important that you hear from other people other than Akebia employees. I mean you'll hear from Akebia employees, but we really want to bring in KMEs to talk about -- when we think about the process we went through to make the decision to in-license 097, Steve always says, when Erik brought this forward, it was like, another complement inhibitor, do we really need this?

And it was really talking to KMEs, one of whom we expect you'll be able to hear at the R&D Day that this concept of a next-generation complement inhibitor really -- I think those are the words that were used. And so hearing the excitement around that product from people other than Akebia employees, I think, is important.

And it will give us the opportunity. We haven't had the opportunity to go into depth on the data that underlies the decisions we made, the data -- the pre-clinical data on praliciguat, for instance, that gave us confidence in moving forward in FSGS. And then it was exciting to get a question on 9090 on this call.

But we -- this is the first product we're putting in the clinic from our own discovery efforts, small but mighty discovery efforts at Akebia and introducing that product and answering questions like Nabeel asked about what differentiates it from vadadustat. So we think it will be a very robust day. I mean it's the kind of thing you can spend six hours on, but we'll do it in a much more streamlined fashion.

But I think it will -- right now, we just introduced this rare kidney pipeline in December. And I don't think people really have had the opportunity to focus on it because quite rightly, they're focusing on the Vafseo launch.

We're really happy with how the Vafseo launch is going. We think that will continue to deliver for the company and be the financial driver for continuing to build the pipeline. But now, people will be able to really understand what we've got and why we're so excited about not just the rare kidney pipeline, but our capabilities in expanding that HIF pipeline as well.

I'm showing no further questions at this time. I'll now turn it back to John Butler for closing remarks.

Great. Thank you, Marvin. I do want to take a moment again to outline the catalyst-rich next 12 months that we have at Akebia. In addition to watching our progress towards standard of care for Vafseo in the $1 billion dialysis market, we'll see Vafseo top-line data from VOCAL in Q4 and VOICE in Q1 of '27.

We'll initiate the 097 basket study in the second half and expect to see the first data in 2027. And we'll begin and complete the Phase 1 study of AKB-9090 during the course of this year as well as continuing to enroll praliciguat Phase 2 in FSGS.

We are very excited about the present and future for Akebia. We're eager to share more about our pipeline programs at our R&D Day on April 2, and I look forward to speaking to you then. Have a great day.

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.