Earnings Call Transcript - AKBA Q4 2025

Operator, Operator

Good day, and thank you for standing by. Welcome to Akebia's Fourth Quarter 2025 Financial Results Conference Call. 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.

Mercedes Carrasco, Senior Director of IR

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 as 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.

John Butler, CEO

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 U.S. 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 III 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 3 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 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 endpoint. Both the extensive preclinical work in FSGS disease models as well as previous clinical results with 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 II 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 I study in healthy volunteers of AKB-9090 in the first half of 2026 with top-line results later this year. 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.

Nicholas Grund, Chief Commercial Officer

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 4 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 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, Vafseo demand in quarter 4 was slightly down versus quarter 3 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 4, 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 3 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 onetime 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 1 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 9 months of 2025 to approximately 91% among the small subset of patients who were on the 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 Vafseo was available in late August and implemented an observed dosing protocol late in quarter 4. 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 making in Vafseo, taking the time and effort to integrate the therapy into protocols and care plans makes 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 onto 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 the standard of care for patients on dialysis. Let me now turn it over to Erik.

Erik Ostrowski, Chief Financial and Chief Business Officer

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 U.S. 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 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 noncash 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 prelaunch 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 U.S. 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 2 years. With that, we welcome questions.

Operator, Operator

Our first question comes from Julian Harrison of BTIG.

Julian Harrison, Analyst

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?

John Butler, CEO

Thank you, Julian, for that comprehensive list. To discuss growth expectations for Vafseo, I'm not providing specific revenue guidance. During a product launch in the dialysis market, we anticipated providers would quickly embrace opportunities related to TDAPA, but we didn't foresee the challenges with adherence we're currently addressing. It's important to focus on demand rather than inventory changes. Demand has remained relatively flat, showing $12 million in the third quarter, $11 million in the fourth quarter, and $12 million in the second quarter. We expect growth from this level, although we cannot predict the exact pace. Some may be hoping for a sudden increase, but in my experience with launches in this market, there is typically more gradual growth compared to oncology. Looking back, products like sevelamer or Renagel saw $20 million in the first year, $55 million in the second, and $130 million in the third, ultimately becoming a $1.3 billion product. Nephrologists tend to adopt products at a slower pace. Currently, DaVita has made the product available but isn't actively communicating to physicians about reimbursement opportunities, leaving that to their discretion. This creates a role for our field teams to promote and educate physicians on the benefits, supported by data from studies like VOICE. The important data presented at last year's ASN meeting hasn't been published yet, but it has been submitted for publication. Our medical affairs team needs these publications to educate physicians effectively. The same applies to the cost analysis being presented this weekend. As we get these studies published and accessible, our sales and medical affairs teams can leverage this information, which will significantly influence physician utilization. I firmly believe that the data we're generating will position Vafseo as the standard of care for managing anemia in this patient demographic. The timeline for this adoption is uncertain, but we are seeing growth and are confident about it, even though we’re not ready to issue guidance. We prefer to observe the continued positive trajectory. Nick, could you elaborate on operationalizing at DaVita?

Nicholas Grund, Chief Commercial Officer

Yes, DaVita made the product widely available across their network in late Q4. They have begun focusing on educating their physicians, starting with the home dialysis population, which includes over 30,000 patients, roughly the size of USRC. This is a significant move and aligns well with USRC as well as the profile of Vafseo. Additionally, they are considering an observed dosing protocol to address some past adherence challenges. However, DaVita won't be pressuring physicians to adopt it; rather, our field teams, including medical educators and sales, will actively support physicians in trying and eventually adopting Vafseo as a standard of care. DaVita is a large organization, and we're encouraged to see many of their physicians starting to use Vafseo in Q4, with that momentum carrying into Q1. As noted, we do not expect an abrupt spike in adoption; instead, we anticipate steady growth month-over-month and quarter-over-quarter as we deepen our penetration.

John Butler, CEO

It definitely depends on how you define significant growth. After three quarters of flat sales, growth is expected. We anticipate continued growth, and the key question is the rate of that growth. One of my biggest surprises was that the uptake didn't happen faster due to the economic advantages of using the drug during the TDAPA period. Ultimately, the emphasis has always been on the clinical benefits, which we are now demonstrating. Nick mentioned the dosing protocols that are being implemented, and we believe that by the end of the year, most patients receiving in-center treatment will be on the observed dosing schedule. This means they will receive the drug three times a week while in treatment, which significantly aids compliance. The feedback we're receiving from physicians, particularly the anemia managers who oversee patient care daily, has been very positive. We're excited to see DaVita progressing with this approach. Additionally, if they concentrate on their home patient population in the first part of the year, it will be excellent for our growth. I hope that clarifies things, Julian.

Operator, Operator

Our next question comes from the line of Roger Song of Jefferies.

Unknown Analyst, Analyst

Congrats on the progress. This is Nabil standing in for Roger. It's encouraging to hear about the improvement in the first refill adherence. Could you share how the second and third refill rates are trending? Additionally, do you have any comments on the education for anemia managers? I have another question as well.

John Butler, CEO

Nick, do you want to take that one?

Nicholas Grund, Chief Commercial Officer

Yes. Let's revisit the importance of the first refill. Historically, we’ve observed about a 75% adherence rate for the first refill following an initial prescription. This increased to 91% in the fourth quarter within a smaller group of patients, which is a key indicator for future trends. We anticipated the larger patient group in the first quarter, particularly in January, to confirm if this trend would hold, and it has. We are currently observing an 87% first refill rate. As patients progress to the second prescription, your question is relevant. We have seen a strong continuation of this adherence rate. It's important to note that these patients often have significant comorbidities and typically experience a 2% to 4% discontinuation rate each month. Nonetheless, the high adherence rates continue to be maintained at around 80% to 90% even as patients move to the second prescription, which suggests positive trends for annual adherence rates.

John Butler, CEO

As the clinical data continues to accumulate, one of the main reasons patients may stop their treatment is due to gastrointestinal tolerability issues. However, we know that these issues are usually temporary. Physicians who believe in the clinical benefits communicate this to their patients, reassuring them that they were prescribed the medication for a reason and that it is expected to help them. They encourage patients to persist through any discomfort, which often subsides. In contrast, there are other physicians or nurse managers who may not be as confident in the drug or lack sufficient understanding of its benefits, and they may easily agree to discontinue the treatment. Nick, would you like to add anything?

Nicholas Grund, Chief Commercial Officer

Yes. 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 3 times a week has allowed them to offset that compliance challenge and really provide Vafseo for that patient.

John Butler, CEO

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

Unknown Analyst, Analyst

Yes. Regarding the 9090 asset, congratulations on the progress. I would like to know more about how it is mechanistically different from previous SPHs. Do you have any additional thoughts on this?

John Butler, CEO

On 9090, Steve, can you take that one?

Steven Burke, Chief Medical Officer and Head of Research and Development

The molecule has a different pharmacokinetics and a slightly different profile. Vadadustat tends to preferentially target the liver. That's where 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 nonclinical 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.

John Butler, CEO

Nabil, 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 with 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 kind of hit the ground running and really ramping up our education. Nick, do you want to add something?

Nicholas Grund, Chief Commercial Officer

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.

Operator, Operator

And our next question comes from the line of Roanna Ruiz of Leerink Partners.

Unknown Analyst, Analyst

This is Michael on for Roanna Ruiz at Leerink Partners. For the 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? Also, how important is the RBC sub-study in differentiating Vafseo's mechanism?

John Butler, CEO

Steve, do you want to take that one?

Steven Burke, Chief Medical Officer and Head of Research and Development

Sure. You're correct about the study involving 350 patients. DaVita believed it was essential to conduct the study in their own facilities to both operationalize it and to confirm that the drug is as safe and effective as the ESAs, specifically Mircera, which they currently use. I anticipate we will observe superiority on certain hemoglobin-related safety endpoints, similar to what we saw in the FOCUS study, indicating fewer rapid rises in hemoglobin, lower peak levels, and reduced need for dosage adjustments. However, while that's all been predefined, it's not classified as a primary endpoint. The primary endpoint is non-inferiority for hemoglobin control, which is logical as you're targeting a specific hemoglobin range. I believe the red blood cell study will be significant because some individuals may not fully grasp how distinct Vafseo is from ESAs. With ESAs, you are essentially administering recombinant human EPO, which binds to receptors on bone marrow cells to aid in their maturation into red blood cells. In contrast, Vafseo interacts in multiple ways. We already know that red blood cells developed under Vafseo's influence differ; they are larger, contain more hemoglobin, and exhibit a more consistent width distribution. This additional information will reinforce our existing understanding that red blood cells produced with Vafseo are indeed different and provide physicians with a rationale for believing in Vafseo’s uniqueness. Consequently, when data emerges regarding outcomes like mortality and hospitalization, it will be more comprehensible to them, providing a mechanism to understand the clinical benefits.

Unknown Analyst, Analyst

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 the FDA?

John Butler, CEO

That's a great question. We have been reworking the protocol just to make it simpler. But fundamentally, it's the same protocol that the 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.

Operator, Operator

Our next question comes from the line of Allison Bratzel of Piper Sandler.

Unknown Analyst, Analyst

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.

John Butler, CEO

Sure, Ashley. We're still finalizing the agenda for that. There’s a lot we could discuss, which is exciting for the company right now. We want to focus on praliciguat and 097, and we believe it’s important for you to hear from experts outside of Akebia. While you will hear from Akebia employees, we want to include key medical experts to share insights on our decision to in-license 097. Initially, there was skepticism about whether we needed another complement inhibitor, but discussions with these experts revealed the potential of a next-generation complement inhibitor, which is significant. Hearing their enthusiasm for the product is essential, and it will allow us to delve into the data that supported our decisions, such as the preclinical data on praliciguat that gave us confidence to proceed with FSGS. It’s also exciting to receive questions about 9090 during this call, as this is the first product from our own discovery efforts at Akebia. We are eager to address questions about how it distinguishes itself from vadadustat. We anticipate a thorough day, though we will keep it streamlined. We introduced our rare kidney pipeline in December, but we recognize that focus has been on the Vafseo launch, which we are pleased with and expect to be a financial driver for our pipeline development. Now, people will have the chance to understand our offerings and our enthusiasm for both the rare kidney pipeline and the potential for expanding the HIF pipeline.

Operator, Operator

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

John Butler, CEO

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 I study of AKB-9090 during the course of this year as well as continuing to enroll in the praliciguat 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 at our R&D Day on April 2, and I look forward to speaking to you then. Have a great day.

Operator, Operator

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