Earnings call transcript: Akebia Therapeutics Q3 2025 sees revenue growth, stock falls

Akebia Therapeutics (AKBA) reported its financial results for the third quarter of 2025, showcasing a notable year-over-year revenue increase but a mixed market reaction. The company reported a net income of $540,000, a significant turnaround from a $20 million net loss in the same quarter last year. Despite these positive financial results, Akebia’s stock fell 14.22% in premarket trading to $1.75, following the earnings announcement. The company reported an earnings per share (EPS) of $0, which was below the forecasted EPS of -$0.04, and revenue of $58.76 million, surpassing the expected $52.06 million.

Key Takeaways

• Akebia Therapeutics achieved a 57% increase in total revenues year-over-year.
• The company’s net income shifted from a significant loss to a modest profit.
• Stock price decreased by 14.22% in premarket trading.
• Vafseo sales reached $14.3 million, with a strong prescriber base.
• Operational challenges persist in patient adherence and protocol implementation.

Company Performance

Akebia Therapeutics demonstrated strong performance in the third quarter of 2025, with total revenues climbing to $58.8 million, up from $37.4 million in the same period last year. This growth was driven by robust sales of its key products, Vafseo and Auryxia. The company is positioning itself as a leader in the dialysis anemia treatment market, despite facing operational challenges in patient adherence and protocol implementation.

Financial Highlights

• Revenue: $58.8 million, up 57% year-over-year
• Net income: $540,000, compared to a $20 million net loss in Q3 2024
• Cash position: $166.4 million in cash and cash equivalents
• Vafseo sales: $14.3 million
• Auryxia sales: $42.5 million

Earnings vs. Forecast

Akebia reported an EPS of $0, which was below the forecasted -$0.04, resulting in a 100% negative surprise. However, the company exceeded revenue expectations with $58.76 million against the forecasted $52.06 million, marking a 12.87% positive surprise. This mixed performance highlights the company’s ability to generate revenue but also points to challenges in managing costs effectively.

Market Reaction

Following the earnings announcement, Akebia’s stock experienced a significant decline of 14.22% in premarket trading, dropping to $1.75. This reaction may be attributed to the negative EPS surprise and ongoing operational challenges, despite the revenue beat. The stock price remains nearer to its 52-week low of $1.52, reflecting investor concerns.

Outlook & Guidance

Looking ahead, Akebia anticipates expanding patient access to approximately 280,000 by 2026. The company is focusing on operational improvements and expects data from the VOICE and VOCALE studies in 2026-2027. Future EPS projections show a gradual improvement, with forecasts of $0.03 in Q1 2026 and $0.46 for the full year 2026.

Executive Commentary

CEO John Butler expressed dissatisfaction with the current Vafseo revenue, stating, "We’re not satisfied with generating $14.3 million in revenue this quarter." Chief Commercial Officer Nick Grund highlighted the product’s potential, noting, "More than half of the nephrologists surveyed view Vafseo as providing more consistent control of anemia than their ESA." Butler also emphasized the company’s growth prospects, saying, "We expect to enter 2026 with something like seven times [the] number of patients who have access to the product."

Risks and Challenges

• Operational challenges in patient adherence and protocol implementation.
• Potential generic competition for Auryxia.
• Market saturation and competitive pressure in the dialysis anemia treatment sector.
• Macroeconomic factors that could impact healthcare spending.

Q&A

During the earnings call, analysts inquired about the company’s operational challenges, particularly in patient starts and inventory transitions. Executives addressed concerns regarding potential generic competition for Auryxia and highlighted positive clinical data presented at the ASN conference.

Full transcript - Akebia Ther (AKBA) Q3 2025:

Conference Call Operator: Today, and thank you for standing by. Welcome to Akebia’s third quarter 2025 financial results conference call. At this time, all participants are in a 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 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today’s conference is being recorded. I would now like to hand the conference over to your speaker today, Mercedes Carrasco, Senior Director of Investor Relations. Please go ahead.

Mercedes Carrasco, Senior Director of Investor Relations, Akebia: Thank you, and welcome to Akebia’s third quarter 2025 financial results and business updates conference call. Please note that a press release was issued earlier today, Monday, November 10, detailing our third quarter 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 also 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. I’d like to remind everyone that this call includes forward-looking statements. Each forward-looking statement on this call is subject to risks and uncertainties that could cause actual results to differ materially from those described in these statements.

Additional information describing these risks is included in the financial results press release that we issued on November 10th, as well as in our 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, Chief Executive Officer, Akebia: Thanks, Mercedes, and thanks to all of you for joining us this morning. The team is just back from a very successful American Society of Nephrology meeting, where we met with prescribers and customers and also presented data that continue to demonstrate the positive impact Vafseo can potentially have on important clinical outcomes in dialysis patients. The quality of data that we believe will lead to Vafseo becoming standard of care to treat anemia in dialysis patients. Of course, today there is significant focus on our current launch progress. I’m proud to share that through 41 weeks of launch, Vafseo has generated more total prescriptions than any recent launch in dialysis. This is a reflection of the recognition from prescribers of the potential clinical benefit Vafseo can bring. That being said, from a business perspective, I’m not satisfied with generating $14.3 million in revenue this quarter.

No one on the Akebia team is. To be clear, we are pleased with the direction of all the important launch indicators that we believe will lead to long-term success for the product. We increased accessible patients from 40,000 patients in the first half of the year to almost 70,000 by the end of Q3 with the initiation of the DaVita pilot and the addition of IRC and several smaller providers late in the quarter. However, as we advance through the launch, we continue to appreciate how long it takes to align all of the logistics and processes for a new therapy to be made available for patients, particularly one that will be delivered to a patient’s home, a departure from how anemia has been treated for the past 35 years.

The bottom line is that getting patients on therapy and, in some cases, keeping them on in the highly protocolized dialysis environment has taken longer than we expected. That said, these are operational issues that we and our dialysis provider customers are working through as quickly as possible. We believe that our positioning is compelling. Market research and every conversation I had at the ASN meeting supports physician desire to prescribe. Nick will share more information on our launch as well as sentiments from prescribers that we heard at ASN. Further, I expect that strong interest from physicians is only going to grow with the WIN-ODS analysis based on data from the INNO2VATE trials that was presented at ASN last week by Dr. Glenn Chertow. The purpose of the WIN-ODS analysis is to bring a greater level of statistical power to analyzing critical clinical outcomes.

It’s a statistical method designed to prioritize clinically meaningful endpoints in outcomes trials. This post-hoc data analysis showed that patients randomized to Vafseo experienced a lower risk of death or hospitalization compared with patients randomized to the ESA control, darbepoetin alfa. The benefit became more significant when you looked at an on-treatment analysis. You’ve heard me say repeatedly that continuing to provide data that supports the clinical differentiation of Vafseo will be critical for the product to become standard of care. This data is an incredibly strong start and an important step in delivering on that promise. We will, of course, work diligently to have these new data published so our medical team can communicate them in the field as appropriate. Moreover, Dr. Block has adopted this WIN-ODS endpoint as the primary endpoint in the VOICE study, which we expect to read out in early 2027.

As a reminder, late next year, we’ll also have the results from the VOCALE study that we’re conducting at DaVita clinics. These readouts will be two important data catalysts for the company, and we believe the newly generated information should support continued long-term growth of Vafseo prescribing. Now, both the VOICE and VOCALE studies utilize three-times weekly or TIW dosing regimens. We’ve said before that observed dosing will be important for the in-center patient population as the dosing schedule can coincide with their dialysis treatments. Now, we plan to engage further with the FDA on adding TIW dosing to the label, but we have heard from physicians and providers that they are moving to this dosing regimen based on the evidence that already exists.

To this end, US Renal Care is currently implementing a TIW dosing protocol in their clinics with a goal to have it available in all clinics in Q1 of next year. I expect some physicians may wait until Q1 to start new patients on Vafseo when they can leverage TIW dosing. Now, additionally, USRC will be shifting from using 150 milligram tablets at home to 300 milligram tablets for in-center use, which could impact inventory levels in Q4. In the long run, I believe this change, enabling observed dosing, will improve physicians’ ability to drive patient adherence and compliance, which have been factors impacting growth. Before handing the call over to Nick, I want to go back to our launch for a moment. Having more prescriptions written in the first 41 weeks of a launch than any recent launch in dialysis suggests a very strong reception from the dialysis community.

Hearing feedback from physicians about their positive experiences with Vafseo and seeing data like Dr. Chertow presented regarding the potential favorable mortality and decreased hospitalization benefits compared to ESAs gives me more reason to believe we will achieve our goal of making Vafseo standard of care for dialysis patients. I’m extremely confident in achieving that long-term goal. In the near term, our team is tackling operational issues head-on to overcome them. Now, let me turn it over to Nick to give more granularity on these efforts. Nick?

Nick Grund, Chief Commercial Officer, Akebia: Thanks, John. Good morning, folks. Like many others at Akebia, I spent the last several days in Houston at ASN talking to nephrologists and leaders from various dialysis organizations. The positive sentiment on Vafseo as a compelling treatment for anemia remains high. In fact, from market research, we now have early insights into the perceptions of nephrologists who have patients on therapy. We’re pleased to see that more than half of the nephrologists surveyed view Vafseo as providing more consistent control of anemia than their ESA with fewer dose adjustments. More importantly, at ASN, we met with all of the large and mid-sized dialysis organizations with prescribing access, and they reinforced that they are vested in the success of Vafseo. All these factors give me confidence that we’ll achieve our goal of making Vafseo standard of care for dialysis patients.

I believe that by continuing to address operational challenges and further improving access, we continue to unlock the true value of Vafseo. To that end, I’ll share quarterly launch metrics. Note that as we bring on more dialysis providers in the coming quarters, we will not be able to continue to provide dosing-level data moving forward. During the quarter, approximately 725 prescribers wrote a prescription for Vafseo, and each prescriber, on average, wrote approximately 12.7 prescriptions. More than 85% of prescriptions were refills in quarter three, and the average dose of those refills has increased 5% versus the prior quarter and 32% above the starting dose. We believe this reflects that physicians are getting comfortable treating patients to the optimal therapeutic dose and that this trend of increasing average dose will have a positive impact on revenue.

In summary, overall, Vafseo demand in quarter three was flat versus quarter two, with new patient starts offset by lower-than-expected initial adherence. With expanded access, we have more to do to gain new prescribers and get more patients on therapy. We have extremely strong advocacy at USRC, as we said before, and saw a strong initial uptake. Now, over 85% of USRC physicians have written a prescription. However, we have seen continued lower adherence at USRC than we expected, lower than the industry standard we shared with you in quarter two, and the adherence rate at USRC is lower than we anticipate at other dialysis organizations. To improve adherence, we revamped and highlighted our messaging. We trained our sales team to better educate physicians, and particularly anemia managers, on potential GI issues and dosing and titration strategies. Our medical team is also supporting USRC in adjusting its protocols.

Much of this work is still continuing, and in recent months, we’ve seen an increase in patients getting a first refill, which we believe means caregivers are beginning to better understand how to successfully treat with Vafseo. While a positive sign that our efforts are making an impact, there’s still more to do. I’m proud of our medical team for identifying solutions to discontinuations at any time and educating prescribers on Vafseo data to support dosing decisions as they address challenging protocol restrictions. Also important, the data we are seeing suggests discontinuations are lower in PD patients and at organizations with protocols permitting three times weekly or TIW dosing. As additional dialysis organizations adopt TIW dosing, including USRC, as John mentioned, we believe we’ll continue to see an increase in patient adherence.

To continue the success of the Vafseo launch, we need to continue to increase prescribing access across dialysis organizations. We referred to having prescribing access when a dialysis organization has created and operationalized a Vafseo treatment protocol. In quarter three, we increased prescribing access by greater than 25,000 patients. Additional patients came from three sources: Innovative Renal Care, or IRC, the DaVita pilot, and a number of other regionally important small and independent dialysis providers. While we anticipated broad access at DCI, the fourth-largest dialysis organization, they have yet not enabled broad prescribing access through a protocol. IRC, the fifth-largest dialysis center, made Vafseo available to patients in mid-August and required all clinic staff to be trained by the end of September. With strong physician advocacy and all staff trained, we expect physicians to trial Vafseo in certain patient subgroups, leading to broader adoption in Q1 2026.

The DaVita pilot in over 100 clinics that treat nearly 10,000 patients also began in mid-August. Within large complex organizations, it makes sense to do a test run to ensure a smooth rollout. During the pilot, we saw patients being identified, labs being drawn, insurance being verified, and patients preparing to go on therapy in quarter four. The pilot was successful in that those processes were streamlined and revised when needed, and patients have since been dosed. We’re pleased to say that DaVita has decided to roll Vafseo out to the remainder of its clinics and that Vafseo is available broadly as of today. With over 200,000 patients within DaVita now having prescribing access, our teams are working with prescribers to identify those appropriate to start on Vafseo.

In summary, while gaining significant traction is taking time, I believe the core tenets of a successful launch are in place and strengthening. We have strong market awareness, increased prescribing access, and we’ve already overcome several operational issues. With prescribing access for Vafseo at over 260,000 patients today, we expect several dialysis organizations to increase ordering in the fourth quarter of this year and, importantly, to build momentum into 2026. Let me now turn it over to Eric.

Eric Ostrowski, Chief Financial and Chief Business Officer, Akebia: Thanks, Nick. We’re happy to report another solid quarter of top-line performance with Vafseo and Auryxia. I’ll now provide an overview of our results as compared to the third quarter of last year. Total revenues, which are comprised primarily of net product revenues and also include license collaboration and other revenues, were $58.8 million in this quarter as compared to $37.4 million in Q3 of last year, representing an increase of over $21 million. Of these amounts, net product revenues increased to $56.8 million this quarter from $35.6 million in Q3 of last year. This was driven by sales of Vafseo, which were $14.3 million in the quarter, as well as by an increase in Auryxia sales, which were $42.5 million this quarter as compared to $35.6 million in Q3 of last year.

As a reminder, Auryxia lost IP exclusivity in March, and there is an authorized generic for Auryxia on the market, though no generics have been approved by the FDA at this time. We are pleased to post another strong quarterly Auryxia result, though caution future Auryxia sales levels are challenging to predict due to the uncertainty around the timing of potential additional generic competition. Cost of goods sold decreased to $9.4 million this quarter as compared to $14.2 million in Q3 of last year. The key driver of this COGS reduction is that we are no longer reporting a $9 million quarterly non-cash amortization charge related to the acquired developed product rights for Auryxia, which is now fully amortized.

Also, of note, Vafseo sales in the quarter were derived from pre-launch inventory, which does not include the full cost of manufacturing, and as a portion of those inventory-related costs were previously expensed to R&D prior to Vafseo’s FDA approval. R&D expenses increased to $14.9 million this quarter from $8.5 million in Q3 of last year, driven by increased clinical trial program activities, including our VOICE and VOCAL studies, which aim to continue to generate data highlighting the benefits of treating patients with Vafseo, as well as higher headcount-related costs. SG&A expenses increased to $29.1 million this quarter as compared to $26.5 million in Q3 of last year. The increase was primarily driven by higher marketing costs in connection with the Vafseo U.S. launch, as well as increased headcount-related expense.

Turning to the bottom line, we generated net income of approximately $540,000 this quarter as compared to a net loss of $20 million in Q3 of last year. This quarter’s net income was primarily driven by the increase in net product revenues, which was partially offset by higher operating expenses. Our cash position is strong. We ended Q3 with $166.4 million in cash and cash equivalents. We believe our existing cash resources and the cash we expect to generate from product, royalty, supply, and license revenues are sufficient to fund our current operating plans of profitability, including the advancement of our existing pipeline. In closing, our Q3 financials reflect our continued execution of the Vafseo launch and the continued steadiness of the Auryxia revenue stream. We look forward to discussing our Vafseo launch progress, as well as the advancement of our pipeline on our next earnings call.

We’ll now open the call up to questions. Operator?

Conference Call Operator: Thank you. As a reminder to ask a question, please press star 11 on your cell phone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from Rowena Ruiz of Leerink Partners. Your line is open.

Great. Good morning, everyone. A couple from me. I was curious, what strategies could you use to overcome the operational challenges that you mentioned for Vafseo, including the average adherence? I think you mentioned that US Renal. Are there any learnings you can take from the pilot program with DaVita that could help you figure this out and enhance it going forward?

Nick Grund, Chief Commercial Officer, Akebia: Rowena, great questions. I think they’re both for Nick, so I’m going to turn it over to him. Yeah, the first part of the question is really strategies around adherence. As we’ve looked at it, typically what we’re seeing is adherence being challenging really in that what we call the first refill. That first refill is immediately following the initial prescription. They get prescribed at the starting dose of 300 milligrams. A lot of those patients who are being started are higher dose ESA patients, so they’re coming from a high dose to 300 milligrams, and they’re experiencing in some cases a hemoglobin dip. What we found out is that the anemia manager is used to their ESA. They’ve been using it for 30 years, and they’re responding by switching the patient back to an ESA as opposed to titrating the drug. It’s a titratable drug.

The average dose in our studies was roughly 435 milligrams. The expectation is to titrate. What we have seen is there is a lack of titration there. What we focused on is really the messaging with our sales team, with the anemia managers around titration strategies and the et cetera. In addition, our medical team has been working with the DOs around protocols associated with how we think about long-term use of the product. Both those things together, we have seen some recent trends that suggest we are moving in the right direction, but still a ton of work to do there. The second piece is DaVita. DaVita Learnings, as the second-largest dialysis organization, they do these pilots for a reason. That is really to work out the kinks. Those kinks can be in places where an initial prescription gets loaded into the system.

That person needs to have a clinical review. They also need to have a reimbursement review. That order then gets sent to the specialty pharmacy, who then fills the prescription at the patient’s home. The idea behind the pilot was to actually test all those aspects. Where needed, DaVita adjusted those. As we think about the learnings from that, with USRC, we saw a very motivated dialysis organization. They were prepared ahead of time with many of those things, so they moved very, very quickly. DaVita took a little bit longer. This is really a prescriber-driven launch within DaVita. It’s not a top-down push of any kind. It’s prescriber by prescriber. It just took us a little time to figure out the distance between the patient being identified and the prescription being filled.

Those learnings, and frankly, all the learnings throughout the launch, we’ve been able to apply to every DO that’s come on board. That’s one of the reasons why we expect adherence in new dialysis organizations who are starting to be actually lower than or higher than the adherence we saw at USRC early on. We’re taking those learnings and we’re sharing them broadly, and we believe they’re having an impact. Now, let me just add a couple of things. The pilot was successful. The learnings were, it takes time to work through it. DaVita seemed very happy with it and, as a matter of fact, rolled out village-wide, as they call it, to their entire community, 200,000 patients as of today, which is sooner, frankly, than we actually expected it.

Where I think Nick was saying, the real learnings came from what we saw at US Renal first and how then protocols and the like were implemented at DaVita and some of the others. In some ways, dialysis is an interesting community in that everybody kind of knows what everybody else is doing, right? There is a lot of communication. I mean, even at the ASN meeting, there is a meeting of Chief Medical Officers across all of the different dialysis providers to share data, kind of activities, things they are doing medically and clinically. We know Dr. Block shared significant information about their experience with Vafseo. We think clearly those learnings impacted how DaVita built their protocol, which, again, we expect will be very, very helpful.

I think even in the early pilot days, we’re not seeing and don’t expect to see the same issues around adherence because of some of the tweaks they made to those protocols. That is the learning too. Nick referenced the anemia manager. The anemia manager is so important to this process. They’re used to giving EPO or Mircera, whatever, in the clinic every day. They see this dip in hemoglobin, and they don’t have control because the drug is at the patient’s home, so they immediately go back to what’s comfortable. They really have to have a lot of training about how to work beyond that. It took like 20-plus years to really understand how to dose ESAs. We’ve been on the market for 41 weeks. I’m amazed at how much progress they’ve made in really understanding how to use the product.

Again, going forward, we’re really confident in the trends that we’re seeing.

Yep. Very helpful. Thanks.

Conference Call Operator: Thanks, Rowena. Our next question comes from Julian Harrison of BTIG. Your line is open.

Hi, everyone. This is Andrew Rothenberg. Julian Harrison, thank you for the update. Just a quick question on one of the presentations from ASN. Could you discuss what physician feedback has been like regarding the post-hoc analysis of Vafseo’s impact on hospitalization outcomes?

Eric Ostrowski, Chief Financial and Chief Business Officer, Akebia: Yes. Andrew, thanks so much for asking that question. It is obviously early days. We only had the presentation last Thursday, I think it was. Certainly a focus of the conversations I’ve had, again, I believe that that was part of the presentation Dr. Block made to the other Chief Medical Officers. We obviously were not in that presentation. This is important data. This is really meaningful data. When you look at the INNO2VATE data overall, we saw about a 1% lower mortality rate and about an 8% lower hospitalization rate. Neither of those were statistically significant. Using this WIN-ODS analysis where you with a hierarchy, right? It is better to be alive than dead. It is better to be out of the hospital than in the hospital. You can really drill down on what matters to patients.

The clinicians that I spoke to were incredibly excited about this. I mean, these, of course, are people who believe in the product already, and this is the kind of evidence that they need. We cannot obviously use this in the field, or the medical folks cannot communicate this until it is published. It is important for us to move that quickly. This is the promise that we believe the drug would have, and it is being demonstrated. We will confirm it prospectively with the voice trial as well. I think hopefully you hear the bullish tone of my voice. I mean, coming off this ASN meeting, not only were people talking about the good experience that they are having and where there is frustration, it is frustration with operational issues.

It’s the, "Hey, this is something that’s going to change care for patients, and they want to be a part of it." Things in dialysis don’t happen overnight, but we’re on the right track. I’m absolutely confident of that.

Thank you. If I could just ask one more quickly, just on acute kidney injury, have you gotten any sense of what the registrational path could potentially look like for this indication? Has there been any communication with the agency on potential expectations?

No, not yet. This is acute kidney injury, it is our compound AKB-9090, which we expect to start phase one early next year. It is a little early for having that conversation. The great thing is there is this group, the Kidney Health Initiative, that ASN sponsors that has multiple manufacturers. The FDA is part of that as well. Lisa Thompson goes to those meetings regularly. Steve Burke, our Chief Medical Officer and Head of R&D, he is a part of that. He actually chairs the drug committee, and he is chairing a special section on AKI. Similar to the way FDA agreed on a path forward for Eigan, and seemingly for FSCS as well through the Parasol activities, I would hope that there will be real clarity on where AKI, what you have to do in a really streamlined way to get an AKI product approved.

We have a few years before that matters to us yet, but it’s great that Steve is directly working on that with the FDA and the ASN and the rest of KHI.

Great. Thank you so much for the updates. Really helpful.

Thanks, Andrew.

Conference Call Operator: Thank you. Our next question comes from Matthew Caulfield of HC Wainwright & Co. Your line is open.

John Butler, Chief Executive Officer, Akebia: Hi. Great. Thank you. Good morning. Just kind of a two-part question. First, for Vafseo, at this stage, what do you view as the greatest hurdles to the LDO and medium dialysis organization expansion for just building on near-term growth? Then separately, for Auryxia, it was mentioned that the generic had not entered the market yet. Was just curious kind of what your thoughts were there. It seems that may come as a slight surprise. Just trying to get sort of your thinking on that. Thanks again. Appreciate it.

Eric Ostrowski, Chief Financial and Chief Business Officer, Akebia: Thanks for the questions, Matt. I’ll take the second one first. Auryxia, this is the gift that keeps on giving. We had an expectation that there would be generic approvals in March. There have not been. We do not know why, and we are certainly not going to ask anyone. We are simply going to continue to provide product to the market. We know exactly what the authorized generic can sell. Obviously, they buy from us. Again, we will continue to provide the market over time. You can see from the revenue numbers, I mean, it has continued to do incredibly well, particularly in this TDAP period for the phosphate binders. As long as that continues, we will take advantage of it. As Eric referenced, I mean, it is just hard to think long-term about it because ultimately, I expect the generic will be approved.

We know this is—we’ve had challenges manufacturing the product. It’s not—we have supply now, but it isn’t as easy as some of the other things we work on. Is that having an influence? I don’t know. We’re happy enough to fill the market need there. The greatest hurdle—I’m going to ask Nick to comment on this in a second—but to me, it’s working through all of these processes at the dialysis providers. It’s not as simple as you launch other drugs. It’s like the doctor wants to write a prescription. They write a prescription. They bring it to the pharmacy. It gets filled. Your work is to get payers to have it on formulary, etc. Here, there’s just so many more hurdles that we’ve had to jump.

We knew we had those, but I think just the timing of getting through them has been frustrating for us. As you get through them, then you have access. It is about driving that demand at the physician level. That is what gives me confidence. This is not a question of, "Do physicians believe in the product?" They want to write it. We have to get through these operational challenges. I do not know if you want to add something there, Nick.

Yeah. Really, really three things. John did a nice job on one of them. The first one is access. When I think about access, getting it to prescribing access where there’s a protocol people can use broadly. Now with DaVita today, the pilot is over, and it’s available to 200,000 patients. That one, I would say, while we still have work to do with Fresenius, we have a number of patients, so 260,000 patients that we can go after here in quarter four and in 2026. I don’t want to say behind us, but certainly a big step forward in this quarter. The second is really the operational issues, which John talked about. I’d say if you met one DO, you’ve met one DO.

In some cases, we need to be the expert on their process so that we can explain that to physicians, prescribing physicians, in order for them to be able to easily get patients on product. I think we’re understanding that, and we’re moving that forward. The last one is the adherence thing, which we talked about a bunch. When I think about adherence, there’s so much learnings that we had from USRC. In fact, they’ve been helping to communicate the learnings at the CMO meeting that John referenced. People are changing the behaviors. They’re changing protocols for new folks to represent the learnings from the USRC experience there, changing their protocols to potentially allow for better adherence with patients. Our team is out there supporting that either from the commercial side or from the medical side.

I really appreciate it.

Oh, sorry. Please go ahead.

Yeah. On access, we started the year at roughly 40,000 patients. We’re going to enter 2026 with something like seven times that number of patients who have access. We just have to work through all of those issues. You go from 10,000 DaVita patients who can get access to the product to 200,000. We’re so pleased that they’re starting earlier because, again, they’re going to work through some of those issues over the course of the next couple of months. That, I think, will put us in a great place to start 2026. Seven times the number of patients who can potentially access the product. That’s without even getting Fresenius, which, of course, we continue to work. Had some great meetings with them at ASN. At some point, they won’t be on an island. They’ll make access for the product as well.

A lot of work to do. Thanks for the questions, Matt.

Yeah. Thank you, guys. Much appreciated.

Conference Call Operator: Thank you. Our next question comes from Roger Song of Jefferies. Your line is open.

Mercedes Carrasco, Senior Director of Investor Relations, Akebia: Great. Thanks for the update and taking our question. Appreciating the current prescription is mostly coming from USRC, strong. Just curious about when you start with those new patients, including the DaVita and then DCI, NRC upcoming. How should we think about the new patient start compared to USRC with a pretty strong start? Also, just a quick question related to the inventory. You mentioned 4Q will be a little bit different. Just give us some color around the 3Q inventory, and then how should we expect for the 4Q? Thank you.

Eric Ostrowski, Chief Financial and Chief Business Officer, Akebia: Yeah. Roger, thanks so much for those questions. I think it’s really important questions. The USRC experience, I don’t believe you should think about kind of projecting that onto the other dialysis providers, right? I mean, what we had at USRC with the advocacy we had from Jeff Block and Mary Dietrich, the CMO and Assistant CMO, it was a push, right? If you think of it that way. They basically said, "Here are the reimbursed patients. Go put them on." You saw that in the first quarter. That was great. At the same time, it led to some of the adherence issues that we’ve been talking about and the fact that the anemia nurses were kind of quick to switch people over. It was great on the one hand because you got this bolus of patients on.

They got a ton of experience, and everyone else has learned from that. As you think about DaVita and IRC and ultimately DCI and Fresenius, it is much more of a prescriber-driven growth in patients, right? It will be on, which is great. I mean, we can handle that very well, right? This is why we have a commercial organization in place and a medical organization to support protocols and the like. It is hard to take that and move it over. You really have to think about each of those in a unique way. Now, again, you have that broad support at the corporate level, but they are not forcing people to write the drug. Remember, during the Tdap period, you still have to go through this process where you have to confirm insurance and the like. US Renal did that first.

Hey, here’s all the patients that are insured." Now the docs need to say, "I want to write it for this patient." Then you have to see that they’re insured. This all takes time to get the patient on. I think we’ve learned a lot through the DaVita pilot process that it took longer than we had expected. They had some glitches with their systems that they’ve worked through. You do not go from 100 sites to however many thousand DaVita has without it does not all turn on a dime. We’re incredibly well positioned for 2026. When I think about some of the meetings we had with the corporate folks at ASN last week and the language they were using to us around where this product should fit, these are the things that give me confidence.

I’ll let Nick answer the question on current inventory, but just the reference point that I made in my remarks. US Renal, again, where most of our sales come from, they’ve been using 150-milligram tablets. That’s what they ship to patients’ homes. So they have inventory of that. They know they’re going to be moving. They’re not going to force anyone, but I expect that most patients and physicians will move to TIW dosing. TIW dosing, the drug is at the dialysis center, obviously, because they give it during dialysis, and they use 300-milligram tablets for that. So they’ll have to work down their 150 inventory. It’s a shorter supply chain because all you have, we ship directly to the dialysis providers. So they don’t need as much inventory on a go-forward basis of the 300.

We do not know exactly what that will be in Q4, but I think it will clearly be a little bit less inventory than they had ending Q3. And that number.

Yeah. They added about $1 million in quarter three in total inventory into their thing. The other thing to keep in mind is they make this switch to TIW. If you’re a physician who wants to put a patient on product, you’re likely to say, "Hey, I want to not put them through a go to QD and then switch them to TIW." There may be some resistance in the system for new patients to start in quarter four while they wait for the TIW protocol to be available to them.

Yeah. Because they’ve made that clear to all the USRC physicians that they’ll be moving to that. They’re doing it gradually through centers and expect to have them all available hopefully early in Q1. I do think that may, if I’m a doc and I have someone I want to start and I know I want to use TIW, I’m going to wait until I can access that probably before I put them on. That could impact patient starts in the fourth quarter. Again, that is what we would expect to be improved adherence and compliance. That’s a long-term win for us for sure.

Mercedes Carrasco, Senior Director of Investor Relations, Akebia: Got it. Thank you.

Conference Call Operator: Thank you.

Eric Ostrowski, Chief Financial and Chief Business Officer, Akebia: Thanks, Roger.

Conference Call Operator: Thank you. I’m showing no further questions at this time. I’d like to turn it back to John Butler for closing remarks.

Thank you so much, DD. Thank you to all of you for joining us this morning. As I said upfront, we’re not satisfied with the revenue number we presented this morning, mostly because with data analyses like we presented last week, we’re gaining awareness of the type of impact that Vafseo can have for patients. We are gaining access to patients. As I mentioned, when we start 2026, we expect to have access to almost seven times as many patients as we did at the start of this year. We’re dealing with the operational issues we’re encountering, and we’re driving demand from prescribers. Coming off this ASN meeting, my confidence has never been higher. I look forward to updating you all on our progress. Thanks, everybody. Have a great day.

This concludes today’s conference call. Thank you for participating, and you may now disconnect. Good.

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