Akebia Therapeutics, Inc. Q4 FY2025 Earnings Call

Good day, and thank you for standing by. Welcome to the KBS Fourth Quarter 2025 Financial Results Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear automated message advice when your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I'd 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 updates conference call. Please note that a press release was issued earlier today, Thursday, February 26th, detailing our fourth quarter and full year 2025 financial results, and that release is available on the investor 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 Eric Ostrowski, Chief Financial and Chief Business Officer. Dr. Stephen 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 VASIO 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 26th, 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 Vafsio, Vatadustat, our oral HIFPH inhibitor for the treatment of anemia due to chronic kidney disease for patients on dialysis. Vafsio, along with our phosphate binder, Eryxia, 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 Vafsio. 2025 got off to a very fast start, before a number of challenges flattened demand in the second half of the year. We address 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 Vafsio to become standard of care in what is a billion-dollar U.S. market opportunity after the Tdappa period ends, when we expect Vafsio 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 Vasio. Today, just over a year into the launch, more than 1,000 prescribers at 24 different dialysis organizations have written a prescription for Vasio, and 290,000 patients have access to Vasio in dialysis clinics with a protocol in place. I'm particularly encouraged by the shifting dynamics we began to see in Q4. 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 Vapcio 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 III Innovate program in dialysis. This analysis demonstrated that patients treated with VASIO 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 Vafsio versus Darvipoetan based on Innovate data. In this analysis, Vafsio 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 Vafsio versus Darvipoetan. 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 Vafsio. 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 the Vita clinics that's evaluating Vasio dose three times weekly the trial also contains a sub study of red blood cell characteristics which we believe could make a compelling argument for Vasio 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 Vafsio 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 valcio 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 2nd to discuss our mid-stage assets in detail, namely perlisiguat and AKB097, as well as introduce our early HIFT PHI AKB9090. Perlisiguat is an oral, once-daily soluble guanylate cyclase stimulator being evaluated in a Phase II 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 Both the extensive preclinical work in FSGS disease models, as well as previous clinical results for prolissaguat and diabetic kidney disease give us confidence in the potential for the therapy to impact FSGS. AKB097 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 multi-billion 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 one 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 Vafsio. Now, let me turn it over to Nick, give more granularity on the launch.

Thanks, John. Good morning, folks. Like John, I am encouraged by the growth potential for Vapsio in 2026, which is supported by early Q1 data. But first, let me recap the Quarter 4, 2025. During the quarter, approximately 800 prescribers wrote a prescription for Vapsio, and each prescriber, on average, wrote approximately 10.3 prescriptions. Of note, 128 of those were new prescribers. During Quarter 4, 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, VASIO demand in quarter four was slightly down versus quarter three, as we reported $6.2 million in VASIO 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 a vast majority of USRC in-center patients to be receiving VASIO 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 VASIO protocol. With the almost five-fold 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 VASIA 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 are 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 will continue to monitor adherence rates in 2026 as centers implement their observed dosing protocols. Second, we're also seeing a nice pickup in utilization and broader adoption from IRC, the fourth largest dialysis center, after IRC made Vasio available in late August and implemented an observed dosing protocol late in quarter four. In addition, DCI has started to put patients on therapy. We also see the number of prescribers within DaVita starting to increase with some physicians trialing Vasio 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 make in VASIO, taking the time and effort to integrate the therapy into protocols and care plans, may be believed that providers and prescribers understand the clinical benefit VASIO can deliver and are committed to using it long-term. As prescribers continue to gain real-world experience as they transition patients onto of Vasio, 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 Eric.

Thanks, Nick. As John mentioned, we saw a strong top-line performance in calendar year 25, as net product revenues increased nearly 50% over calendar year 24, driven by the U.S. introduction of Vasio and increased sales of Rixia. 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 VAPCO revenues and advance our pipeline, including our mid-stage rare kidney disease program. I'll now provide an overview of our Q425 and calendar year 25 financial results as compared to the prior year. Total revenues were $57.6 million in Q425 compared to $46.5 million in Q424 and $236.2 million in calendar year 25 compared to $160.2 million in calendar year 24. These increases were driven by sales of Vapteo and an increase in Eryxia sales. Vapteo net product revenues were $6.2 million in Q425 and $45.8 million in calendar year 25. As Nick mentioned, Q4 Vapteo sales were negatively impacted by the inventory drawdown at USRC. Eryxia net product revenues were $48.1 million in Q425 compared to $44.4 million in Q424 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 Eryxia to expand this year beyond the current authorized generic competition and therefore expect Eryxia revenues to decrease in 2026 as compared to 2025 Eryxia. Turning to expenses, cost of goods sold was $12.5 million in Q425 compared to $20.4 million in Q424 and 39.5 million dollars in calendar year 25 compared to 63.2 million dollars in calendar year 24. COGS in both periods was driven by higher Eryxia sales volumes in 2025 and was impacted by the elimination in 2025 of a quarterly 9 million dollar non-cash intangible amortization charge being occurred through q4 of 2024. in addition COGS for calendar year 24 included a 12.3 million dollar benefit due to our ability to sell inventory previously written down as excess inventory. Of note, VAPCO-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 reported as R&D expenses in the period incurred prior to VAPCO's approval in the U.S. R&D expenses were $26.6 million in Q425, compared to $11.8 million dollars in q424 and 62.4 million dollars in calendar year 25 compared to 37.7 million dollars in calendar year 24. the increase in expenses in both periods was driven by increased clinical trial related activities for vasio and our other product candidates higher headcount related costs as well as by a 12.8 million dollar charge incurred during q425 related to acquired in-process r d costs associated with the acquisition of AKB 097. SG&A expenses were $26.1 million in Q425 compared to $27.7 million in Q424 and $107.5 million in calendar year 25 compared to $106.5 million in calendar year 24. Net loss in Q425 decreased to $12.2 million as compared to a net loss of $22.8 million in Q424. 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 expense. Turning to the balance sheet, cash and cash equivalents as of December 31, 2021-2025 for $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 plan for at least the next two years. With that, we welcome questions.

Thank you. At this time, we'll conduct the question and answer session. As a reminder to ask a question, you will need to press Star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press Star 1-1 again. Please stand by while we compile the Q&A roster. And our first question comes from the line of Julian Harrison of BTIG. Your line is now open.

Thank you for taking the questions. I have a few, and I'll just go one by one here. First, can you talk more about your expectations for sequential VAPCO growth in 2026? I'm 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 Vafcio access at DaVita currently is. Are the vocal data a big gating step there, or do you expect broad commercial uptake at to Vita before the vocal data are reported.

Great. That's a great list, Julian. Thanks. So expectations for growth first in VAPSIC. So we're not guiding for revenue. So I'll start with that. I mean, again, when you're in a launch, particularly in this dialysis market, if you saw last year, I certainly expected, A, that dialysis providers would latch onto 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 we kind of forget the inventory fluctuations. We give you the demand number and really think about that. Demand basically has been flat. We had $12 million in the third quarter, $11 million in the fourth quarter, and it was actually 12 in the second quarter as well, right? So, you know, we absolutely expect and are seeing growth from that level. You know, exactly how quickly that will increase. I think some people are kind of looking for this sort of magical hockey stick. And, you know, 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 Civellum or Renagel launch. We did $20 million in the first year, $55 million in the second year, $130 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 know, 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 DeVito. where DaVita's 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, you know, it's things like the data from Forrest. So you look at the data from the ASN meeting last year, 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, you know, in publication peer-reviewed, which we expect is going to happen this year. But, you know, then the same thing will be the case with the cost analysis that's being presented this weekend. You 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 in 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 VASIO, is going to be standard of care for this patient population. It really is just a question of how quickly that happens. And, you know, we're seeing growth now. We're confident in that growth. But, you know, 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 the USRC in total. In total, yeah. It really fits well within the profile of VASIO. So super excited about that. Second, they're also, you know, 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, you know, but Davida 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 Vasio, or sales, selling Vasio, that are really going to help physicians try and then increase usage and then ultimately adopt Vasio as a standard of care. And so when we think about that process, you know, DaVita is a fairly big organization, you know, getting them to try it. And we're very encouraged. You know, in the quarter four, we saw a number of DaVita physicians starting to utilize Vasio, 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 how you define a hockey stick, right? Three quarters of flat sales, you will have growth. So, you know, 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, you know, 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, you know, what we're showing now. And, you know, Nick talked about the observed dosing protocols that are being put in place. you know, 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, you know, 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, you know, 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 would be fantastic for us from a growth perspective. Hopefully that helps, Julian.

Excellent. This is very helpful all around. Thank you very much.

Thank you. One moment for our next question. Our next question comes from the line of Roger song of Jeffrey's. Your line is now open.

Hey, good morning, team. Congrats on the progress, and thanks for taking our question. This is Nabil on for Roger. It's encouraging to hear about the improvement in the first refill adherence. I was curious if you'd 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, you know, super, let's kind of repeat the first refill, because I think it is significant. So historically, we've seen roughly a 75% adherence on the first refill. So 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, you know, this 87% first refill rate. As they move into the second prescription, I think your question is a really good one, we've seen, you know, significant continuation of that adherence rate. And so, you know, you have to remember these patients have significant comorbidities, comortality, they receive transplants. There's an 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.

You know, and the other thing you're going to see, as the clinical data continues to build, you know, even if a patient, you know, one of the main reasons that a patient would go off is if they feel like they have some GI tolerability issues. Well, 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, say, I understand you're dealing with it, but we put you on this medicine for a reason. You know, we really believe this is going to benefit you. I want you to try to work through it and, you know, it will go away. And it does. And then there's other physicians or nurse managers who aren't as, you know, as sold on the drug, maybe is the way to say it, or don't have the same level of education on the product benefits, and they'll acquiesce and take the patient off, right? So, Nick, do you want to add something?

Yeah, the only thing I'd probably add is, and by people moving from daily dosing to observe 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 VASIO 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 VASIO for that patient.

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

Oh, good. Yeah. Thank you so much for those updates and that color. Just on the 90-90 asset, again, congrats on the progress here. Just curious if you can comment a little bit more on how that's mechanically differentiated from prior SPHs, and then any other thoughts there?

On 90-90, Steve, are you on?

Can you take that one? The molecule has a different pharmacokinetics and a slightly different profile. Vatidustat tends to preferentially target the liver. That's where the erythropoietin is made, whereas 90-90, 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, 90-90 was clearly the best compound that we had for that indication, whereas that at least that probably would not work in that indication. So it's all about the structure and the PK. Thank you. Very helpful.

That's all for me.

And then, Bill, I think your other question was around anemia manager education. And I think it may be important to point out, you know, we definitely recognize how significant that is. And, you know, a lot of that education has to be done through the medical affairs folks, our MSLs. You know, 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. You know, 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, you know, we're still finalizing the last couple of positions there, but, you know, those folks have kind of hit the ground running and, you know, are really ramping up our education.

Nick, you want to add something? And, you know, it's great to see that the dialysis organizations are actually participating in that education, right? So, you know, USRC, we've had great advocacy from Dr. Dietrich and Dr. Block all along, and they've been educating proactively. Within DeVito, 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 VASIO. Thank you.

Thank you. One moment for our next question. In our next question comes the line of Rona Ruiz of Lering Partners. Your line is now open.

Hi, this is Michael on for Rona Ruiz at Lering Partners. Thank you for taking our question. 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 endpoints? And also, how important is the RBC sub-study in differentiating the ASCO's mechanism? Thank you.

Steve, do you want to take that one? Sure. Yeah, no, you're right about the study. It's 350 patients. Devita 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, Mercer, 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, you know, that's all pre-specified, 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 between 10 and 10. I do think the red blood cell study will be interesting and important because I think there may be some, you know, people who aren't really as close to this don't understand how different VAPCO 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 VAPCO does so many more things. And we already know that the red blood cells that are made under the influence of VAPCO are different. They're bigger. They have more hemoglobin. They have a more uniform distribution of widths. 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 Vafcio is different. And then when we have data around things like death and hospitalization, it makes more sense There's a mechanism by which they can understand these clinical benefits.

Got it. Thank you. Another question, if I may, have you reactivated the IND for AKB097 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. Thank you.

Thank you. One moment for our next question. Our next question comes to the line of Alison Bratzel of Piper Sandler. Your line is now open.

Hi, this is Ashley on for Allie 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 2nd, when you're discussing your pipeline, can you help frame some expectations for investors? You know, what do investors look forward to? You know, what level of detail are you planning to provide? Any caller 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, you know, there's so much that we could talk about. That's kind of the exciting thing for the company right now. You know, there's so many areas we can go. But I think, you know, we really want to focus on ProLisiglot and 097. And, you know, we think it's important that you hear from people other than Akebia employees. I mean, you'll hear from Akebia employees, but we really want to bring in KMEs to talk about, you know, when we think about the process we went through to make the decision to in license 097, you know, Steve always, you know, kind of says, you know, when Eric brought this forward, it was like, oh, another complement inhibitor? Do we really need this? And it was really talking to KMEs, you know, one of whom, you know, we expect you'll be able to hear at the R&D Day, that, you know, 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 Akibia employees, I think is important. And it'll give us the opportunity. We haven't had the opportunity to kind of go into depth on, you know, the data that underlies the decisions we made, the data, the preclinical data on ProLisiglob, for instance, that gave us confidence in moving forward in FSGS. And then, you know, it was exciting to get a question on 9090 on this call. But, you know, this is, you know, the first product we're putting in the clinic from our own discovery efforts, you know, small but mighty discovery efforts at Akebia and kind of introducing that product and answering questions like Nabil asked about, you know, what differentiates it from Vatiducet. So we think it'll 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, you know, 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 Vafcio launch. You know, we're really happy with how the Vafcio launch is going. We think that will continue to, you know, to deliver for the company and be the financial driver for, you know, continuing to build the pipeline. But now people will be able to really understand, you know, 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.

Great. I really appreciate it.

Thanks, Ashley. Good to talk to you.

Thank you. 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 AQBF. In addition to watching our progress towards standard of care for Vafcio and the billion-dollar dialysis market, we'll see Bafcio 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 I study of AKB9090 during the course of this year, as well as continuing to enroll the Prolisiglot Phase II in FSGS. We are very excited about the present and future for Akebia. We're eager to share more about our pipeline programs that are on D-Day on April 2nd, and I look forward to speaking to you then. Have a great day.

Thank you for your participation in today's conference. To start to conclude the program, you may now disconnect.