Akebia Therapeutics Q2 2026 Earnings Report

Akebia Therapeutics EPS Results

• Actual EPS: -$0.02
• Consensus EPS: -$0.04
• Beat/Miss: Beat by +$0.02
• One Year Ago EPS: N/A

Akebia Therapeutics Revenue Results

• Actual Revenue: $49.13 million
• Expected Revenue: $48.85 million
• Beat/Miss: Beat by +$276.00 thousand
• YoY Revenue Growth: N/A

Akebia Therapeutics Announcement Details

• Quarter: Q2 2026
• Date: 8/5/2026
• Time: After Market Closes
• Conference Call Date: Wednesday, August 5, 2026
• Conference Call Time: 4:30PM ET

Akebia Therapeutics (NASDAQ:AKBA), a clinical-stage biopharmaceutical company headquartered in Cambridge, Massachusetts, is focused on the development and commercialization of therapies for patients with kidney disease. The company’s lead product candidate, vadadustat, is an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to treat anemia associated with chronic kidney disease in both dialysis-dependent and non-dialysis patients. Akebia’s research and development efforts also extend to preclinical programs targeting nephrology and related metabolic disorders.

Since its founding in 2007, Akebia has pursued strategic collaborations to advance its clinical pipeline and expand its market reach. The company has partnered with Otsuka Pharmaceutical for filing and commercialization of vadadustat in the United States, while Mitsubishi Tanabe Pharma holds rights to develop and commercialize the compound in ex-Japan territories. These alliances leverage Akebia’s scientific expertise alongside the global commercialization networks of its partners.

In addition to its focus on anemia in kidney disease, Akebia evaluates novel mechanisms of action aimed at improving kidney health and patient outcomes. The company maintains clinical trial sites across North America and engages with healthcare providers, academic institutions and patient advocacy groups to support the design and execution of its studies. Under the leadership of President and Chief Executive Officer John P. Butler, Akebia continues to build its development infrastructure and prepare for potential regulatory milestones.

Akebia Therapeutics Q2 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Vafseo’s VOICE trial delivered a strong outcome: an interim analysis in 2,116 dialysis patients showed statistically significant superiority on the composite of mortality and hospitalization, driven by a 10% reduction in hospitalization. The trial was stopped early after exceeding its prespecified criteria.
• Positive Sentiment: Vafseo net product revenue rose 34% sequentially to $21.3 million, with more than 10,500 active patients and a 17% increase in prescribers. Management cited expanding adoption among mid-sized dialysis organizations and growing engagement from DaVita following the VOICE results.
• Neutral Sentiment: Akebia initiated a phase II basket trial of ebribafusp in IgA nephropathy, lupus nephritis, and C3 glomerulopathy, with initial data expected in 2027; a phase II ANCA-associated vasculitis study is planned for next year. Praliciguat’s phase II FSGS trial continues enrolling, while AKB-9090 phase I data are expected early next year.
• Negative Sentiment: Akebia expects Vafseo revenue to decline in 2027 despite higher unit volume because planned pricing after the TDAPA period ends on December 31, 2026 will be substantially lower. AURYXIA revenue fell to $25.5 million from $47.2 million a year earlier due to generic competition, contributing to a quarterly net loss of $8.9 million.

Presentation

[Operator]

Ladies and gentlemen, thank you for standing by. This is Roy, and I will be your conference operator today. At this time, I would like to welcome everyone to the Akebia second quarter 2026 financial results. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. If you would like to ask a question during this time, please press star followed by the number one on your telephone keypad. If you would like to withdraw your question, please press star one again. I would now like to turn our conference over to Mercedes Carrasco. Please go ahead.

[Mercedes Carrasco, Senior Director of IR and Corporate Communications at Akebia]

Thank you, and welcome to Akebia's second quarter 2026 financial results and business updates conference call. Please note that a press release was issued earlier today, Wednesday, August 5th, detailing our second quarter 2026 financial results, and that release is available on the investors section of our website. For your convenience, a replay of today's call will also be available on our website after we conclude. Joining me today, we have John Butler, Chief Executive Officer, Dr. Steven Burke, our Chief Medical Officer, Nick Grund, our Chief Commercial Officer, and Erik Ostrowski, Chief Financial and Chief Business Officer. 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.

[Mercedes Carrasco, Senior Director of IR and Corporate Communications at Akebia]

Additional information describing these risks is included in the financial results press release that we issued on August 5th, as well as in the Risk Factors and Management Discussion and Analysis section of our most recent annual and quarterly reports filed with the SEC. With that, I'd like to introduce our CEO, John Butler.

[John Butler, CEO at Akebia]

Thanks, Mercedes, and thanks to everyone for joining us this afternoon. As you know, we've been focused on two critical areas of our business that we believe will deliver both important therapeutic advances for patients and value to shareholders. Those are advancing our kidney disease pipeline and making Vafseo standard of care for the treatment of anemia due to CKD in dialysis patients. We've had incredibly important advances in both areas since we last spoke to you. Today, I'll start with research and development. I believe our pipeline is underappreciated, and clinical advancement of our rare disease pipeline specifically provides the greatest opportunity to build value. Earlier this week, we announced that we initiated the phase II basket trial to evaluate ebribafusp, previously known as AKB-097 and ADX-097, in IgA nephropathy, lupus nephritis, and C3 glomerulopathy.

[John Butler, CEO at Akebia]

We believe ebribafusp, a next-generation complement inhibitor, could be truly differentiated in the rare kidney disease space in these indications and others. Beyond this initial basket study, we're doing the work to prepare for a phase II study in ANCA-associated vasculitis and expect to start that study next year. Our other rare kidney asset, praliciguat, continues to enroll in its phase II study in FSGS. As with Ebri, we believe there are multiple indications where Prali can play an important therapeutic role. Again, we believe the mechanism of Prali will allow it to occupy a unique competitive position in these rare diseases that each have significant unmet need. Our third kidney disease clinical candidate is AKB-9090, which was in a phase I study in healthy volunteers. 9090 continues to move successfully through the SAD/MAD study, and we expect to report data early next year.

[John Butler, CEO at Akebia]

Following that data readout, our plan is that next year, our development team's efforts and our dollars will be focused on Ebri and Prali, where we believe the largest opportunity to drive near-term value exists. Dr. Steven Burke, our Chief Medical Officer, is currently attending GlomCon Hawaii, where medical professionals around the world have met to discuss treatments for glomerular disease. That's the reason we're having our call this afternoon rather than our normal morning timing. I'll now ask Steve to share a few remarks on Ebri and Prali. Steve?

[Steven Burke, CMO at Akebia]

Thank you, John. We've built upon our team's commitment to patients and expertise in kidney disease to advance several programs into the clinic in 2026. We believe our mid-stage pipeline products, ebribafusp and praliciguat, have the potential to deliver differentiated and targeted approaches to severe diseases with high unmet need. As John mentioned, we just initiated a phase II basket trial for Ebri. The goal of this trial is to evaluate the safety and efficacy of Ebri in patients suffering from diseases marked by complement activation in the kidney glomeruli, namely IgA nephropathy, lupus nephritis, and C3 glomerulopathy. These rare kidney diseases affect thousands of patients, and while there are therapies available, each requires lifelong treatment. The currently available treatments include complement inhibitors, which suppress the complement system in the blood, and many require frequent administration.

[Steven Burke, CMO at Akebia]

Importantly, they generally have a box warning for significant infection risk, and this profile creates concern for long-term use. In non-clinical studies completed by Q32 Bio, Ebri was shown to be targeted specifically to the sites of complement activation. In patients with complement mediated glomerular diseases, we believe Ebri should localize to the affected glomeruli, which have significant deposits of C3d, while avoiding complement inhibition in the blood. We highlighted this during our R&D Day in April and expect the findings from non-clinical and phase I studies to be published in medical journals. During our R&D presentation, Dr. Jonathan Barratt, Mayer Professor of Renal Medicine from the University of Leicester, shared that he believed a complement inhibitor with this profile could be used long-term and in combination with B-cell-directed therapies such as APRIL and APRIL-BAFF inhibitors without the associated potential of systemic complement inhibition.

[Steven Burke, CMO at Akebia]

The recently initiated phase II BASKET trial is expected to enroll up to 30 patients and will evaluate a once-weekly subcutaneous dose of Ebri for 26 weeks in the main study, followed by a long-term extension study for responders. In the phase I study of Ebri in healthy volunteers, again conducted by Q32 Bio, this same dose achieved exposures necessary to provide tissue-specific complement inhibition without inhibiting the complement system in the blood. The primary endpoint of the phase II study is the incidence of adverse events, and secondary endpoints including the change in proteinuria and kidney function. In addition, the trial will measure Ebri pharmacokinetics and complement biomarkers in the blood and urine to detect if Ebri reduces complement activity in the kidney tissue while avoiding inhibition of the complement system in the blood.

[Steven Burke, CMO at Akebia]

The phase II BASKET trial is open label. We expect to report initial data in 2027. With regards to our phase II study of Prali in patients with FSGS, enrollment activities are ongoing. FSGS is characterized by focal and segmental scarring in the glomeruli. Prali is a small molecule that is designed to stimulate the soluble guanylate cyclase enzyme and has been shown in animal models of kidney disease to inhibit glomerular scarring and preserve kidney function. There are about 40,000 patients currently diagnosed with FSGS in the U.S.

[Steven Burke, CMO at Akebia]

This trial will enroll up to 60 patients with primary or genetic FSGS in a randomized, double-blind, placebo-controlled trial. The primary endpoint is change in urine protein-creatinine ratio, or UPCR, from baseline to week 24. The secondary endpoint is partial remission of proteinuria, defined as a 40% UPCR reduction and a UPCR less than 1.5 g per gram.

[Steven Burke, CMO at Akebia]

In a phase II study of diabetic kidney disease conducted by Cyclerion, Prali demonstrated rapid and sustained reduction in proteinuria as measured by urine albumin creatinine ratio, or UACR. We look forward to providing further updates on these studies. Now I will turn it back over to John.

[John Butler, CEO at Akebia]

Thanks, Steve. Now let's turn our attention to Vafseo and our efforts to make this important product standard of care. We had a very positive surprise this quarter when Dr. Geoff Block of U.S. Renal Care completed the planned interim analysis of the primary endpoint in the VOICE trial and found the statistical result significantly exceeded the pre-specified stopping criteria. Vafseo demonstrated a statistically significant and clinically meaningful reduction in the primary composite endpoint of all-cause mortality and hospitalization, with the result driven by a 10% reduction in hospitalization. USRC Kidney Research stopped the trial after a recommendation from the independent data monitoring committee and trial steering committee. For reference, the VOICE trial enrolled 2,116 patients.

[John Butler, CEO at Akebia]

Results of the planned interim analysis as of June 1st demonstrated that the trial met the predefined stopping criteria with a win odds of 1.16 and a P value of 0.0016, establishing non-inferiority and superiority of the primary composite endpoint. We've always had confidence in the clinical differentiation of Vafseo and the potential for a positive outcome of the study, but we were extremely pleased that we had this result earlier than expected. The result is consistent with the post-hoc analysis of the phase III INNO2VATE program, published earlier this year in the Journal of the American Society of Nephrology. When you look at both VOICE and the INNO2VATE analysis, you see that Vafseo demonstrated a consistent result whether dosing the product daily or three times weekly, and whether comparing Vafseo to a long-acting or a short-acting ESA.

[John Butler, CEO at Akebia]

It's also important to note that no head-to-head study of ESAs has ever demonstrated a significant benefit in hospitalization. We believe these data will make a huge difference for patients for years to come. As I've said many times, our goal is to make Vafseo standard of care for dialysis patients. Frankly, the VOICE data gives me greater confidence that we will achieve that goal. I'm especially encouraged by the increased interest we're seeing from the dialysis providers since we made the announcement.

[John Butler, CEO at Akebia]

At the same time, we currently have only shared data through a press release. Dr. Block is working with our support to present these data at a medical conference and have it published in a peer-reviewed journal as quickly as possible. While the tangible impact of this provider interest could take some time, we believe these data help competitively position and differentiate Vafseo moving forward.

[John Butler, CEO at Akebia]

In the meantime, I'm pleased to report that we had our first quarter with over 10,000 patients and $20 million in revenue. Here's Nick to provide more insight into the quarter. Nick?

[Nick Grund, CCO at Akebia]

Thanks, John, and good afternoon, folks. We're pleased to report significant sequential quarterly revenue growth as well as several adoption metrics and an important milestone with more than 10,500 patients active on Vafseo. Vafseo net product revenue increased to $21.3 million in quarter two of 2026, a 34% increase over the previous quarter, representing a continuation of robust growth. The total patients on therapy in quarter two represents an approximate 41% increase compared with quarter one.

[Nick Grund, CCO at Akebia]

Once again, in this quarter, we had the highest number of new patient starts in a quarter since the first quarter of launch, demonstrating strong momentum. The diversification of our prescriber base continues to grow. Today, approximately 1/3 of our prescribers are in LDOs outside of USRC. Additionally, a vast majority of patients are being treated under LDO-implemented observed dosing protocols, which is very much in line with our expectations.

[Nick Grund, CCO at Akebia]

The mid-sized dialysis organizations, USRC, IRC, and DCI, drove the most significant portion of patient growth. We believe that all three still have significant room to grow moving forward. Another common feature of these three customers is the significant level of support in Vafseo that their leadership is demonstrating. Driving prescribing within DaVita is our highest priority as it represents our most significant growth opportunity from a single dialysis organization. In quarter two, we continue to see additional new prescribers and patients on Vafseo at DaVita. As is the case with our mid-sized dialysis organization customers, while it is important to educate prescribers and caregivers on Vafseo, an inflection point comes with top-down support.

[Nick Grund, CCO at Akebia]

To that end, I'm encouraged by the continued high level of interaction between the teams from Akebia and DaVita, bolstered in the past month by DaVita's interest in learning more about the recent VOICE trial results. While I don't expect to see a meaningful increase in the DaVita adoption curve in quarter three, there is a heightened level of senior clinical team engagement regarding detailed operational implementation that we have not seen historically. We believe this bodes well for more impactful growth at the end of the year and sets us up well for 2027. At this stage of the launch, to best support dialysis organizations' engagement overall, in quarter two, we implemented a more targeted, streamlined, and agile commercial strategy that prioritizes a greater focus on large group practices and strategic partners.

[Nick Grund, CCO at Akebia]

The goal is to increase the efficiency and effectiveness of our commercial field team, while at the same time taking advantage of the broad awareness and breadth of patient access created previously. Our team continues efforts to drive Vafseo prescribing and growth. We understand how important it is for our commercial and medical affairs teams to work closely to engage with dialysis organizations and care decision-makers and support prescribers as they continue to get more experience with Vafseo to increase depth of prescribing as well. Now I'll turn it to Erik to go through the financials.

[Erik Ostrowski, Chief Financial and CBO at Akebia]

Thanks, Nick. Total revenues were $49.1 million in Q2 2026 compared to $62.5 million in Q2 2025. This decrease was due to lower AURYXIA revenues, which were partially offset by higher Vafseo. Turning to the components of total revenues, Vafseo net product revenues were $21.3 million in Q2 2026 compared to $13.3 million in Q2 2025, representing a 60% year-over-year increase. As we've previously discussed, we note that upon the expected end of Vafseo's TDAPA period on December 31, 2026, we plan to price Vafseo within the price range of ESAs, which is significantly lower than Vafseo's current price.

[Erik Ostrowski, Chief Financial and CBO at Akebia]

As a result, while we expect Vafseo unit sales volumes to increase in 2027 as compared to 2026, we expect 2027 revenues to decrease compared to 2026 due to this lower planned price. AURYXIA net product revenues were $25.5 million in Q2 2026 compared to $47.2 million in Q2 2025.

[Erik Ostrowski, Chief Financial and CBO at Akebia]

We continue to expect AURYXIA revenues to decrease in 2026 due to generic competition and price pressure. License, collaboration, and other revenues increased to $2.4 million in Q2 2026 compared to $2 million in Q2 2025. Cost of goods sold was $10.4 million in Q2 2026 compared to $9.9 million in Q2 2025. Of note, Vafseo-related COGS in both periods 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 U.S. approval. R&D expenses were $14.1 million in Q2 2026 compared to $11 million in Q2 2025. This increase was driven by activities related to our phase II clinical trials for fulvestrant and abiraterone, as well as higher headcount-related costs.

[Erik Ostrowski, Chief Financial and CBO at Akebia]

SG&A expenses were $28.2 million in Q2 2026 compared to $26.6 million in Q2 2025, driven by higher commercialization-related activity. Net loss was $8.9 million in Q2 2026 compared to net income of $0.2 million in Q2 2025. The change to a net loss this quarter was the result of lower revenues and higher expenses, including a $1.9 million expense related to the commercial reorganization mentioned by Nick, which is aimed at increasing the efficiency and effectiveness of our commercial efforts.

[Erik Ostrowski, Chief Financial and CBO at Akebia]

Cash and cash equivalents as of June 30, 2026, were approximately $155.5 million compared to $162.6 million as of March 31, 2026. We believe our existing cash resources and the cash we expect to generate from product, royalty, supply, and license revenues, along with our plan to refinance our senior secured term loan facility, will enable us to fund our current operating plan for at least two years.

[Erik Ostrowski, Chief Financial and CBO at Akebia]

With that, we will now open the line for questions. Operator?

[Operator]

Thank you. We will now be opening the question-and-answer session. If you'd like to ask a question, press star then the number one on your telephone keypad. To withdraw your question, please press star one again. Thank you. Your first question comes from Matthew Caulfield with H.C. Wainwright. Please go ahead.

[Matthew Caulfield, Analyst at H.C. Wainwright]

Hi. Thank you, guys, and really great to see the progress across the platform. Regarding the Vafseo penetration into the dialysis organizations, obviously you've discussed the in-center dosing protocol being an important part of that in terms of adherence and growth. Do you think the near-term growth in the coming quarters is more a factor of new patients getting onto therapy, or simply broadening the in-center protocol across those current Vafseo patients? I guess I'm just getting at kind of the best ways to think about the near-term growth drivers overall. Thanks.

[John Butler, CEO at Akebia]

Nick, you want to take that?

[Nick Grund, CCO at Akebia]

Yeah, Matt, great question. Thanks. Really with the new patients, what we're seeing is a couple different things. One, the number of clinics that are starting patients is continuing to expand. It's not just within a certain clinic. The number of prescribers continues to grow. It grew 17% this quarter versus quarter one. People are starting to try Vafseo outside of, we'll call it existing physician base. Certainly that generates a bunch of new patients. In addition, frankly, restarts are going really well. As you recall, we had QD patients that fell off therapy in 2025 as they've rolled through these observed dosing protocols. We've seen just about 25% of those discontinued patients actually come back on therapy, which is also helping the growth rate as well.

[Nick Grund, CCO at Akebia]

A couple different factors in there, but most of the growth is coming through the new patients, new clinics, and new providers.

[Matthew Caulfield, Analyst at H.C. Wainwright]

Got it. Thank you. I appreciate that.

[John Butler, CEO at Akebia]

Just about every metric of growth is increasing quarter-over-quarter. We're really seeing that breadth of prescribing and patients increase. It's great to see the restarts as well. We're really very encouraged by that. Obviously, we hope the VOICE data only continues to accelerate that. Do you have another question, Matt?

[Matthew Caulfield, Analyst at H.C. Wainwright]

Absolutely. Thank you. No, that's it. I appreciate it.

[John Butler, CEO at Akebia]

Thank you.

[Operator]

Your next question comes from Roanna Ruiz with Leerink. Please go ahead.

[Analyst at Leerink]

Hi, this is Anna on for Roanna. Thanks so much for taking our question. Two questions from us. Just wondering if you could better characterize the persistence rates, such as 90 and 80-day persistence rates, rather than just first refill adherence, and give any color on maybe the principal reasons for discontinuation now that you have the three times a week dosing. The second, just wondering what the timeline is for getting VOICE data in front of the medical organizations and how much you might expect that to move these net new prescriber additions beyond the good growth you've seen so far. Thanks so much.

[John Butler, CEO at Akebia]

Great. Nick, you want to take the adherence question?

[Nick Grund, CCO at Akebia]

Yeah. When it comes to adherence, where we talk about this first refill item, we've seen real good consistency there. About 89% of those patients who receive a prescription for Vafseo get the refill for the next period, which is really strong. After that, it really tapers down towards what I'll call normal churn in the dialysis patient population. The second part of your question was why do people discontinue? No therapy I know of actually works in every patient. You may have some folks that get hospitalized during that period, go back onto an ESA, come back into the clinic, and then they'll work to put them back on Vafseo. You got folks that just don't tolerate it. Maybe there's some GI issues associated with it.

[Nick Grund, CCO at Akebia]

At this point, I think we've done a nice job in moving to an adherence rate on first refill that is where we want it to be.

[John Butler, CEO at Akebia]

That's where when we launched the product and you had this QD dosing, and particularly the anemia managers saw people's hemoglobins drop, as we told them it would. They just weren't used to not controlling that. We really believe that that was the main reason for that first refill kind of drop in adherence. I think the data supports that that really was the case. Beyond that, it really is what you normally see in a dialysis population. I think, Anna, your second question was around the timeline to get that data to the dialysis provider. This is clearly an ongoing effort. As I said, I think it's important to note that it's not been presented and it's not published, but this is a relatively small community, right?

[John Butler, CEO at Akebia]

We know that Jeff Block is incredibly excited about this data as we are. I know he is talking to dialysis providers, his peers at other dialysis providers, independent of our conversations. I know Steve and his team have also been having those conversations. There are places where, like U.S. Renal ran the study. They've been our strongest supporter, and I think that will only continue to increase. IRC and DCI also, certainly IRC, incredibly excited about the clinical benefit. This only really increases that excitement. The way we look at it, between those three providers, you've got about 66,000 patients in total. Most of whom, or at least 80% of whom are on an ESA today, and we've got just over 10,000 patients treated. Huge amount of room to grow there.

[John Butler, CEO at Akebia]

Again, the conversations that have been had at the clinical level at DaVita, certainly. As Nick mentioned, now the conversation is much more operational in nature, that really, to me, bodes well. Again, it's a very large organization that we've learned takes a lot of work to move, but there seems to be some real momentum there. We're encouraged by that. We don't mention Fresenius a lot, but we believe that this is the kind of data that will be meaningful for them as well, those conversations are starting, I think they'll be much more interested in seeing it published.

[Analyst at Leerink]

Great. Thank you so much.

[John Butler, CEO at Akebia]

Thank you.

[Operator]

Your next question comes from Roger Song with Jefferies. Please go ahead.

[Analyst at Jefferies]

Hey, team, this is Nabil on for Roger. Thanks for the updates. Congrats on the progress. Maybe if you could comment a little bit more on the pipeline on praliciguat. Any thoughts on how enrollment is progressing? Any color there as well. How do we see with recent developments in that space, I guess, following on ebribafusp, with recent developments on that space, how do you see potential combination use? Thank you.

[John Butler, CEO at Akebia]

I'll take the first part, and then I'll turn it over to Steve. Enrollment's progressing. It is a competitive space, which we knew. The team is continuing to drive more patients on, feel good about adding more sites, et cetera. We really look forward to saying, "This is when we expect to see that six-month data." We don't want to put that stake in the ground until we're really confident that we're going to have those 60 patients fully enrolled in the study. We are making progress on it. I think what you're referring to is you look at that, the first quarter, Travere just announced their very early data in FSGS for that first approved product last night, and it is 40,000 patients, a very heterogeneous disease where multiple products will make a real difference for patients in this market.

[John Butler, CEO at Akebia]

This is a massive commercial opportunity and a massive opportunity for patients as well. It's worth kind of driving this forward as quickly as we can. I'll let Steve comment on the opportunity for combination therapy or polypharmacy.

[Steven Burke, CMO at Akebia]

It's Steve. For FSGS, we will be able to treat patients who have persistent proteinuria despite being on ACE and ARBs or endothelin antagonists. I'm actually delighted to see the uptake of sparsentan, and there's plenty of patients who will benefit. Our drug may work well with sparsentan as well. That's something we'll need to determine in future clinical trials. In terms of ebribafusp, there is a real desire to have treatments that are safe and effective and work quickly. Complement-mediated diseases, the complement that's being activated is damaging the kidney cells, and if you use a complement inhibitor, generally you get a very rapid response to stop the kidney damage, and clearly could be used with other therapies.

[Steven Burke, CMO at Akebia]

There's been a lot of exciting data about APRIL and APRIL-BAFF inhibitors, and I think those are going to be very good products in the long term. They're directed at suppressing the B cells that are making autoantibodies, and there's no reason these drugs couldn't be used together. I think this is one of the things that Dr. Barrett had highlighted, that those drugs are quite profoundly immunosuppressive in terms of B cells and affect your ability to respond to new infectious agents. I think there is a lot of interest in having a complement inhibitor that is highly effective, but inherently safer because it doesn't suppress the complement system in the blood. I think time will tell, but I think there's clear opportunity for combination use. I hope that answered your question.

[Analyst at Jefferies]

Thank you.

[John Butler, CEO at Akebia]

Hey, Steve. Go back to FSGS and Prali for a moment. I think one of the things I've heard you talk about with other folks is the difference in mechanism, the unique mechanism of Prali, and how it is quite different from the way sparsentan works and why that might actually be a benefit.

[Steven Burke, CMO at Akebia]

Sure. Yeah. Sparsentan works by blocking the angiotensin receptor and the endothelin receptor. Blocking endothelin is good because endothelin is a vasoconstrictor. It's injurious to podocytes, which are those critical cells in the glomeruli that are the barrier to protein spilling into the urine, and it's also anti-inflammatory and anti-fibrotic. Praliciguat is hitting a completely different pathway, the soluble guanylate cyclase pathway, which leads to increases in cyclic GMP. Prali is a dilator. It's also protecting the podocyte and has anti-inflammatory and anti-fibrotic properties. They're doing very similar things, just from modulation of a different pathway. There's no reason they shouldn't work well together.

[John Butler, CEO at Akebia]

Great. Thank you, Steve, and thanks, Nabil. Next question, operator.

[Operator]

Again, if you would like to ask a question, please press star one on your telephone keypad. Your next question comes from Julian Harrison with BTIG. Please go ahead.

[Andrew Kassin, Analyst at BTIG]

Hi, this is Andrew Kassin on for Julian Harrison. Congratulations on the results and progress this quarter. Thanks for taking our questions. Just a few from us here. First, you touched on some of the key factors driving Vafseo revenue growth. How much of the growth was driven by ex-USRC uptake? Next, have any dialysis providers changed or accelerated their protocol decisions since the VOICE results were shared a little more than one month ago? Has the feedback been more on an individual physician level thus far? Finally, on DaVita, I know this has been alluded to a bit, is there any more color on the progress at DaVita that could be provided? Is there a future step up in uptake we should be thinking about regarding DaVita in terms of timing specifically?

[Andrew Kassin, Analyst at BTIG]

If so, could you maybe give us a little bit more of a sense of when? Thanks for taking our questions and congrats again.

[John Butler, CEO at Akebia]

Thanks, Andrew. I'll just comment quickly on DaVita. Again, DaVita put the CIWA Protocol in place, and that was an important step. We're seeing growth, Nick mentioned this in his remarks. It's really that top-down advocacy that has made the difference at U.S. Renal IRC DCI. Those levels of discussions we're seeing now really suggest that we're making progress there. Honestly, those conversations were happening before VOICE because of the INNO2VATE data, I believe. This idea that this product can make a difference versus ESAs on hospitalization. I would say it's become more, urgent is the wrong word, it's been a more robust conversation with the VOICE data. Nick, I think you have more to add on the DaVita side. You can take the other question as well.

[Nick Grund, CCO at Akebia]

Yeah. DaVita, we recently got some market research that was fielded at the beginning of June from a company called Serix. What that shows is from DaVita physicians in particular, all-time high in terms of their awareness of Vafseo, all-time high with a likelihood to recommend, and also an all-time high in their preference to use Vafseo instead of an ESA to improve efficacy. There is this pent-up desire to use Vafseo within DaVita. We've just got to help the process, and help the leadership help the process from the top down to be able to allow them more rapid adoption of Vafseo. The other questions, the first question, I think, was utilization outside of USRC. Roughly, a third of physicians now prescribing Vafseo are non-USRC physicians. That kind of speaks to the diversification.

[Nick Grund, CCO at Akebia]

USRC has been kind of going gangbusters since the beginning. IRC and DCI really started at the beginning of 2026. They're a little bit smaller, but together they make up just about the size of USRC, and they're demonstrating very strong growth as well. I think John pointed out earlier, there's so much more room to grow in those organizations. When you think about 10,000 patients, and John had 66,000 patients or 60,000 patients between the three of them, there's a ton of growth still yet to be had, which is also encouraging.

[John Butler, CEO at Akebia]

Yeah. We're all focused on DaVita. With 200,000 patients, that can make a huge difference and turn those percentages on their ear. We really are encouraged by what we're seeing there. The hard thing is to really pinpoint exact timing of when that happens. When you get that kind of support, takes a long time to get it, but once you get it sticks around also. I think that's really important as we think about the long term here. Again, as I said, we don't talk a lot about Fresenius, but I believe this clinical data from VOICE, when this is published and presented, this will make a difference. Those physicians who treat patients at Fresenius want to give their patient the best care as well.

[John Butler, CEO at Akebia]

There's tremendous room for us to grow, even in a world where we have to take this price decrease, which we will for the end of TDAPA. We recognize that. This is still an extremely significant market that we think will have the standard of care product in.

[Nick Grund, CCO at Akebia]

Julian, you also asked about protocol changes since VOICE. There has been a lot of dialogue between all LDOs. Dr. Block has been pretty active in talking about his VOICE results, which is encouraging. The only protocol change I will note is, DaVita, in the very beginning of June, did roll out village-wide their three times weekly or observed dosing protocol. I think that is really going to be helpful in physicians overcoming some of the compliance concerns they may have had prescribing the product at home.

[John Butler, CEO at Akebia]

I think that is some of the conversations that Steve's team is having with them now is looking at that versus what was in VOICE and when you start hearing them get very specific about, "What do we do when this happens or that happens?" That gives you a lot of encouragement. They are not asking those questions to pass the time, right? They are really looking to do something. We just have to see when. Stay tuned.

[Andrew Kassin, Analyst at BTIG]

Thank you very much.

[John Butler, CEO at Akebia]

Thanks, Andrew.

[Operator]

That concludes with our question-and-answer session. I would now like to turn the call over to John Butler for closing remarks. Please proceed.

[John Butler, CEO at Akebia]

Thanks, operator, and thanks to all of you for joining us this afternoon. We are really encouraged by the Vafseo growth trajectory through the first half of the year. As we've been saying, the reaction we're seeing from dialysis providers to the announcement of the VOICE data. We believe in the long-term prospects for Vafseo and believe it can contribute significantly to Akebia's success. At the same time, I do ask that you consider the opportunity that advancement of our pipeline, specifically Ebri and Prali represents for us. Notably, the opportunity to potentially bring important products to compete in rare disease markets worth many billions of dollars in expected total value. We are eager to update you on the progress of our trials, and we plan to share data as quickly as we can. Have a great day, everybody.

[Mercedes Carrasco, Senior Director of IR and Corporate Communications at Akebia]

Goodbye.

[Operator]

Ladies and gentlemen, this concludes today's call. You may now disconnect.

Participants

Executives

• John Butler, CEO
• Steven Burke, CMO
• Erik Ostrowski, Chief Financial and CBO

Analysts

• Mercedes Carrasco, Senior Director of IR and Corporate Communications at Akebia
• Nick Grund, CCO at Akebia
• Matthew Caulfield, Analyst at H.C. Wainwright
• Analyst at Leerink
• Analyst at Jefferies
• Andrew Kassin, Analyst at BTIG