Akebia Therapeutics, Inc.AKBANASDAQ
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Operator: Good day, and thank you for standing by. Welcome to Akebia's Third Quarter 2025 Financial Results Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Mercedes Carrasco, Senior Director of Investor Relations. Please go ahead.
Mercedes Carrasco: Thank you, and welcome to Akebia's Third Quarter 2025 Financial Results and Business Update 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 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 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. 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 10 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: 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 a 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. But 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 in 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-Odds analysis based on data from the INNO2VATE trial that was presented at ASN last week by Dr. Glenn Chertow. The purpose of the Win-Odds 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 vadadustat 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-Odds 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 VOCAL study that we're conducting at DaVita clinics. These readouts will be 2 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 VOCAL studies utilize 3 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, U.S. 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?
Nicholas Grund: 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 midsized 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 will 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. But 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 3, 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 3 was flat versus quarter 2, 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 2, and the adherence rate at USRC is lower than we anticipate at other dialysis organizations. To improve adherence, we revamped and highlighted our messaging, retrained 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 is 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 suggest discontinuations are lower in PD patients and at organizations with protocols permitting 3 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 the Vafseo treatment protocol. In quarter 3, we increased prescribing access by greater than 25,000 patients. Additional patients came from 3 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 to 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. And during the pilot, we saw patients being identified, labs being drawn, insurance being verified and patients preparing to go on therapy in quarter 4. The pilot was successful in that those processes were streamlined and revised when needed and patients have since been dosed. We are 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 Erik.
Erik Ostrowski: 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 results, 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 costs reduction is that we are no longer recording a $9 million quarterly noncash 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 prelaunch inventory, which does not include the full cost of manufacturing and as a portion of Vafseo inventory-related costs were previously expensed 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 plan to 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?
Operator: [Operator Instructions] And our first question comes from Roanna Ruiz of Leerink Partners.
Roanna Clarissa Ruiz: So 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 the U.S. renal. And 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?
John Butler: Great questions. And I think they're both for Nick. So I'm going to turn it over to him.
Nicholas Grund: Yes. 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. And that first refill is immediately following the initial prescription. So 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 milligram and their experience, 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. So the expectation is to titrate. And what we've seen is there's a lack of titration there. And so what we focused on is really the messaging with our sales team with the anemia managers around titration strategies and 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. And both those things together, we've seen some recent trends that suggest we're 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. And that's 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. And the idea behind the pilot was to actually test all those aspects. And where needed, DaVita adjusted those. And so as we think about the learnings from that is with USRC, we saw a very motivated DO dialysis organization. They were prepared ahead of time with many of those things. So they move very, very quickly. DaVita took a little bit longer. So this is really a prescriber-driven launch within DaVita. It's not a top-down push of any kind. It's prescriber by prescriber. And it just took us a little time to figure out the distance between the prescription being -- the patient being identified and the prescription being filled. Those learnings and frankly, all the learnings throughout the learn, we've been able to apply to every deal that's come on board. And 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. So we're taking those learnings and we're sharing them broadly, and we believe they're having an impact.
John Butler: Let me just I add a couple of things. The pilot was successful. So 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. But where I think Nick was saying, the real learnings came from what we saw at U.S. Renal first and how then protocols and the like were implemented at DaVita and some of the others. We're -- in some ways, dialysis is an interesting community in that everybody kind of knows what everybody else is doing, right? And there's a lot of communication. I mean even at the ASN meeting, there's a meeting of Chief Medical Officers across all of the different dialysis providers to share data kind of activities, things they're doing medically and clinically. And we know Dr. Block shared significant information about their experience with Vafseo. And 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. So 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 or whatever in the clinic every day. So 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. And 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, and we've been on the market for 41 weeks. And I'm amazed at how much progress they've made in really understanding how to use the product. And again, going forward, we're really confident in the trends that we're seeing.
Operator: And our next question comes from Julian Harrison of BTIG.
Andrew Kassin: This is Andrew Kassin on for Julian Harrison. 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 vadadustat's impact on hospitalization outcomes?
John Butler: 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. But certainly a focus of the conversations I've had. And again, I believe that, that was part of the presentation Dr. Block made to the other Chief Medical Officers. We obviously weren't in that presentation. But 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, but neither of those were statistically significant. using this winds analysis where you -- with a hierarchy, right? It's better to be alive than dead and it's better to be out of the hospital than in the hospital. You can really drill down on what matters to patients. And 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. So we can't obviously use this in the field or the medical folks can't communicate this until it's published. So it's important for us to move that quickly. But this is the promise that we believe that the drug would have, and it's being demonstrated. And of course, we'll confirm it prospectively with the VOICE trial as well. So we're -- again, I think, hopefully, you hear the bullish tone of my voice. I mean, coming off this ASN meeting, not only where people were talking about the good experience that they're having and where there's frustration, it's 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. So things in dialysis don't happen overnight, but we're on the right track. I'm absolutely confident of that.
Andrew Kassin: And 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?
John Butler: No, not yet. This is acute kidney injury is our compound AKB-9090, which we expect to start Phase I early next year. So it's a little early for having that conversation. The great thing is there's this group, the Kidney Health initiative that ASN sponsors that has multiple manufacturers, the FDA is part of that as well. Elisa Thompson goes to those meetings regularly. And Steve Burke, our Chief Medical Officer and Head of R&D, he's a part of that. He actually chairs the Drug Committee, and he's chairing a special section on AKI. So similar to the way FDA agreed on a path forward for IgAN and seemingly for FSGS as well through the PARASOL activities, I would hope that there'll be real clarity on where AKI or 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.
Operator: Our next question comes from Matthew Caufield of H.C. Wainwright & Company.
Matthew Caufield: Just kind of a 2-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? And then separately, for Auryxia, it was mentioned that the generic had not entered the market yet. And I 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.
John Butler: 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 haven't been we don't know why, and we're certainly not going to ask anyone. We're simply going to continue to provide product to the market. So we know exactly what the authorized generic can sell. We -- that obviously, they buy from us. So again, we will continue to provide the market over time. You can see from the revenue numbers. I mean, it's continued to do incredibly well, particularly in this TDAPA period for the phosphate binders. So as long as that continues, we'll take advantage of it. As Erik referenced, I mean, it's just hard to think long term about it because ultimately, I expect the generic will be approved. But 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. So is that having an influence? I don't know. But we're happy enough to fill the market need there. And 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, et cetera. Here, there's just so many more hurdles that we've had to jump. And we knew we had those, but I think just the timing of getting through them has been frustrating for us. But as you get through them, then you have access. And then it's about driving that demand at the physician level. So that's what gives me confidence. This isn't a question of do physicians believe in the product. They want to write it. We've got to get through these operational challenges. I don't know if you want to add something there, Nick.
Nicholas Grund: Yes, really, really 3 things, and 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. And so 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 4 and in 2026. And so 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 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. And 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, and people are changing behaviors. They're changing protocols for new folks to represent the learnings from the USRC experience. They're changing their protocols to potentially allow for better adherence with patients. And our team is out there supporting that either from the commercial side or from the medical side.
Matthew Caufield: Please go ahead.
John Butler: Yes, on Access, we started the year at 40,000 -- roughly 40,000 patients. We're going to enter '26 with something like 7x that number of patients who have Access. We just have to work through all of those issues. So 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. But that, I think, will put us in a great place to start 2026. 7x the number of patients who can potentially access the product, and that's without even getting Fresenius, which, of course, we continue to work, had some great meetings with them at ASN. And at some point, they won't be on an island. They'll make access for the product as well. So -- but a lot of work to do. Thanks for the questions Matt.
Operator: And our next question comes from Roger Song of Jefferies.
Jiale Song: Appreciating the current prescription is mostly coming from USRC strong. And then just curious about when you start with those new patients, including the DaVita and then DCI IRC upcoming. So how should we think about the new patient start compared to USRC with a pretty strong start? And then also just a quick question related to the inventory. So 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?
John Butler: Yes, Roger, thanks so much for those questions. So I think it's a really important question. The USRC experience, I don't believe you should think about kind of projecting that on to 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, they -- it was a push, right? If you think of it that way. They basically said, here are the reimbursed patients, go put them on. And you saw that in the first quarter. And 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. So it was great on the one hand because you've got this bolus of patients on. They got a ton of experience and everyone else has learned from that. But as you think about DaVita and IRC and ultimately DCI and Fresenius, it is much more of a prescriber-driven growth in patients, right? So 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. So it's 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 you're just not -- they're not forcing people to write the drug. And remember, during the TDAPA period, you still have to go through this process where you have to confirm insurance and the like. So U.S. 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, and this all takes time to get the patient on. So I think we've learned a lot through the DaVita pilot process that it took longer than we had expected, and they had some glitches with their systems that they worked through. But again, you don't go from 100 sites to however many thousand DaVita has without -- it doesn't all turn on a dime but we're incredibly well positioned for '26. And 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, again, 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, U.S. renal, again, where more of our -- 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 of -- we ship directly to the dialysis providers. So they don't need as much inventory on a go-forward basis of the 300. So we don't 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...
Nicholas Grund: Yes. So they added about $1 million in quarter 3 in total inventory into their thing. The other thing to keep in mind is they make the 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 4 while they wait for the TIW protocol to be available to them.
John Butler: Yes. 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 early -- hopefully, early in Q1. And 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. So that could impact patient starts in the fourth quarter. But again, that is with the -- what we would expect to be improved adherence and compliance, that's a long-term win for us for sure.
Operator: I'm showing no further questions at this time. I'd like to turn it back to John Butler for closing remarks.
John Butler: Thank you so much, [ Dedi ], and thanks 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 '26, we expect to have access to almost 7x 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, and I look forward to updating you all on our progress. Thanks, everybody. Have a great day.
Operator: This concludes today's conference call. Thank you for participating, and you may now disconnect.