Okay. All right, great. All right, thanks, thanks everyone. Thanks for joining us again for the Guggenheim Healthcare Innovation Conference. Next up in this room, pleased to have Akebia Therapeutics, an interesting story in the kidney space that we've been following for some time. I'm following them on for those of you who don't know, one of the biopharma analysts here at Guggenheim, joined on the stage by John Butler, the CEO of Akebia, and Erik Ostrowski, the CFO and CBO. Maybe, John, I'll start with you. For those unfamiliar with the story, there's obviously been a lot of changes at the Akebia story over the last couple of years too. Maybe you can just sort of give an overview on the history and the story and where we are now, and then we'll dive into some of the exciting more recent updates. Yeah, thanks, Tomas. Thank you so much for the invitation first. It's great to be here. Akebia is a company focused on kidney disease. Our mission is to better the lives of people impacted by kidney disease. We have two commercial products. We have Auryxia, which is a phosphate binder. This is a product that's a mature product, really kind of past its patent expiry at this point. We're enjoying the fact that it's still, there's only one AG on the market. Our second product, and really I think where we'll spend most of our time talking, is Vafseo. Vafseo is our hypoxia-inducible factor prolyl hydroxylase inhibitor that's approved here in the U.S. to treat patients, the anemia of CKD for patients who are on dialysis. We just launched the product at the beginning of the year. We're kind of three quarters in and excited by what we're seeing so far. Okay. Yeah, great. I think we want to dive into that for sure in terms of the recent metrics that you're launching. Maybe just sharing that you guys just reported earnings this morning also, just sort of an overview on the progress you made in these three quarters so far and any other sort of key metrics that you've been following since the launch. Like I said, I mean, we're excited by what we're seeing in the market. We reported $14.3 million in revenue this quarter. Frankly, as we said this morning, we're disappointed in that number because all of the metrics behind are so positive. This is dialysis. We never guided on the revenue line because dialysis is so complicated. As our Chief Commercial Officer, Nick, said this morning, you've seen one dialysis provider, you've seen one dialysis provider. It's so true. U.S. Renal Care was the third largest dialysis provider. They have incredibly strong clinical advocacy there. The day we launched the product, they pushed out to their individual dialysis centers, here's the patients who have reimbursement, they should get on Vafseo. I mean, the idea is they truly believe in this differentiated mechanism of action beyond U.S. Renal Care. They're still the largest part of our revenue base. We're making great progress. There's about 36,000 U.S. Renal patients for the first half of the year. Between U.S. Renal and some of the smaller providers, we had access, true access to about 40,000 patients. As we sit here today, that access has grown to about 260,000 patients, much of it today. When today, DaVita, which is one of the two large dialysis providers, actually moved from a pilot, which they finished successfully, which we kind of helped really understand how they were going to move the product through their system. They've now made this village wide, they call it, basically across all of their dialysis providers, dialysis centers. It went from 100 dialysis centers to over 4,000 dialysis centers who can now access the product. Again, I mean, I was frustrated by it because it has just taken a long time to move through their systems. They're very, very complicated animals. All of this with this reimbursement, I'm sure we'll get into TDAPA, but heavy control over what physicians use. Physicians very much want to use the drug, looking forward to it. We're working through these operational issues. You shouldn't interpret that the dialysis providers, they want the drug to be available as well. They just have systems that are like, you have the ocean liners that you have to turn. It does take time to make that happen. We're super excited about the access that patients have now, we're excited about physicians' experience with the drug. We're really excited about data that we just presented at the ASN that demonstrated the outcomes benefit for the product. I'm sure we'll talk more about that. Yeah, yeah. Maybe just before, obviously big news, DaVita side of things, in terms of the U.S. Renal, anything that you sort of saw, I mean, obviously it's challenging. I think we all know that these markets are really tough here, but learnings from that that you can translate over as you get greater access to more patients? Oh, 100%. I mean, it's really a ton of learnings. The great thing is it really feels very much like a partnership with U.S. Renal. I mean, Jeff Block and Mary Dietrich, who Mary's the CMO and Jeff is Associate CMO, I can't remember his title. I mean, we've worked with Jeff over a number of companies over 30 years, great trialist, great clinician. They're real believers in Vafseo. Their perspective is that everyone who can be on the product should be on the product. We put a lot of patients on quickly. This is a different product with a different mechanism of action versus the ESAs. It took 20 years to figure out how to use ESAs. We've been available for nine months. We saw things like in our clinical trial, you saw that everyone starts at 300 milligrams. Frequently, if a person's on a higher ESA dose, you see a bit of a drop in their hemoglobin levels. That is normal. We thought we educated people on that. They have been managing anemia in a certain way for the last 35 years. Now we are saying this is an oral product. You send that home with the patient and they take it at home. There are anemia managers, mostly nurses in the units. They see a drop in the hemoglobin level and they kind of say, "Oh my God," they switch them back to EPO. Meanwhile, you just have to titrate them and get them through. This is the discontinuation or the lower adherence rate that we are seeing. We recognize that. The clinical folks there recognize that, started to adjust the protocols, educate the nurse managers, the anemia managers more. Ultimately, they're moving to TIW or three times weekly dosing where they can observe the patient taking the drug. We have lots of clinical data to support doing that. Those kinds of learnings, the great thing about dialysis is the clinical people talk to each other. Jeff worked with the DaVita clinical folks. When they built their protocol, they built it so that they timed the dosing of Vafseo with the timing, the dosing of the last dose of ESA. They're not going to see as much of a decrease. They train the anemia managers more closely. Early days, but we're not seeing those same adherence issues that we've seen at U.S. Renal. It's great that in this sense, the community really works. As you think about kind of furthering it, looking next couple of quarters here in the uptake, how are you thinking about just because some of it is maybe just making sure the street understands these dynamics, which I think people are understanding now, but in terms of whether it's guidance or just making sure there's visibility. So people aren't surprised. Right. Yeah. No, it's really important. As I said, we didn't guide because you know there's complexity here. This has even been surprising to us how long it's taken to move things through. Again, it's not for a lack of demand from the physician's perspective. That's super important. As we think about this quarter, again, today, which is earlier than expected, we have DaVita has now come online for the entire company. When I look at how they rolled out the pilot, they had some computer glitches in getting insurance verifications and things that are now all resolved. I think about this being November 10th and saying the rest of this quarter, I expect that they'll take some time. Will there be more patients getting on? 100%. I mean, I absolutely believe that. I kind of think in terms of January 1 comes after the holidays, everything will be in a great position with 200,000 DaVita patients who can access the drug if they have TDAPA payment. It is really this quarter, we do expect to see growth. IRC, which is the fourth largest dialysis provider, they started up in the middle of August, then started training everybody. It was really just the beginning of this quarter that they started to add patients onto the drug in a more meaningful way. On the other side of that, U.S. Renal, they are moving to that TIW dosing. If you're a physician at US Renal and you have a patient who you want to put on the drug, you know in a month you're going to be able to put them on TIW dosing, which is your preference, you'll probably wait and put them on then. It might impact patient starts to a small extent this quarter, but I think the long-term value of that, keeping people on the drug, is definitely worth that. There is this more technical issue around when they send prescriptions home, they use 150 milligram tablets. That's how they titrate the dose. In center, they're going to use 300 milligram tablets. The five-ish weeks of inventory they have now on hand, they'll probably work down. I know they'll work down over the course of the quarter and bring the 300 up, but probably not as much because the supply chain is shorter. We ship directly to the dialysis provider and they can get product from us in two days. There'll probably be some impact on that. Again, that's inventory. That's in and out and it's not meaningful from an actual demand perspective. Okay. You mentioned obviously DaVita and some of the big providers. In terms of other providers coming on board, in terms of one large one you did not mention, that was. One large one we didn't mention is Fresenius. Yeah. And Fresenius has definitely been more difficult. We met with them at the ASN meeting last week and shared the Glenn Churchow data. Again, this data, it's a post hoc analysis from INNOVATE, but it's a meaningful data analysis. In INNOVATE, we saw about a 1% decrease in mortality rate or lower mortality rate in the Vafseo group and about 8% lower hospitalization rate. When we use this win odds analysis, which really juices the statistical power and you compare each person in the Vafseo group to each person in the Darbepoetin and the ESA group, you really build the statistics. What we found was statistically significantly lower risk of mortality or hospitalization with Vafseo. You share that with the dialysis provider and it becomes more and more difficult for them to say, but this is just, it's non-inferiority. We try to be really conservative about how Fresenius is going to move on this. We believe that this product is going to be standard of care. We think the data exists today and with things like VOICE, which we'll talk about, we think we'll generate more data to get to be standard of care. They'll be there as well. I think they're clearly coming along more slowly, but they have 200,000 patients. If at some point next year they make the product available more broadly, that's going to be a great upside for us. Maybe just building on some of what you said there, I was going to ask you about the ASN data, so the feedback you received. You touched on it a little bit, but maybe a little bit more just the conversations you were having last week. Yeah, it's been great. I mean, it really was a phenomenal meeting for us. This, again, you have folks who truly believe there's a difference with this HIF mechanism, this more physiologic approach to increasing hemoglobin. It's not just you're getting your hemoglobin up here and up there. The idea that you're doing it in a more gradual way, you're mobilizing iron more effectively. You have a more physiologic red blood cell that you're creating, which is the VOICE study we'll discover. That's going to lead to differences in outcome. While this is a post hoc analysis, there's no more objective pre-specified data collection than you're alive or dead, you're in the hospital or not. They were already, most providers saw that 8% difference in hospitalization. We know that's good for the patient, but it's also good for the dialysis provider. If a patient's in the hospital, they're not sitting in the chair and being dialyzed. And about 20% or 30% of their patients, they're fully capitated on. So they're at risk for hospitalization. That was meaningful, even though it wasn't statistically significant from INNOVATE. When you see this more powerful analysis and you really drive statistical power. When you looked at the same analysis on treatment, which was on treatment plus 28 days, you give a shot of Darbepoetin and it lasts in the system for 28 days, whereas with Vafseo, obviously you're giving it every day. The p-value becomes 0.0001. Clearly there is a clinical impact here that matters. To hear that, to physicians to hear that data, we got a lot of excited physicians that I talked to at ASN. Again, it's not published yet. Just presented at ASN. We'll get that published. In manuscript form, our medical folks can kind of walk around and talk about it as appropriate. The folks who were at ASN, it really had a meaningful impact on them. Okay. And then maybe going back to the commercial side, you touched on TDAPA earlier. You do have TDAPA now for Vafseo. Can you maybe just talk about what that means for the product in terms of the outlook there? Yeah. Yep. TDAPA, a lot of times you talk to investors and it's like Peanuts cartoon on a bar. I mean, it's tough, right? I mean, dialysis reimbursement is a bit more complicated. TDAPA is Transitional Drug Add-on Payment Adjustment. It's important in that it gives you the ability to bill for an innovative product like Vafseo outside of the bundle for two years on an ASP basis. They're not taking a risk that on the business side, they look at it and say, because of the way we structured our contracts and there's a spread for them, they're willing to allow physicians to use it and clinicians then get to see what are the right patients that they can use it in. It's important and it allows us to sell for two years at a higher price. For us, competing in the anemia space where 90% of patients are actually treated and there's significant money in the dialysis bundle, we take the long-term view. There's about $16 in the dialysis bundle that's for an ESA. You're about $2,500, $16 times 156 treatments. It's about $2,500 a year. That's a billion-dollar market with 500,000 patients who are treated. That's the way we look at it. Tdapa is a nice two-year opportunity for us to want to sell as much as we can because we're selling it at a higher price. As we think about the long-term growth of the product, we think about it in terms of at $2,500 per patient, we can have a very profitable product. It's a billion-dollar market. If we're standard of care, that means you have at least half of the market on the drug. You're at least a $500 million product. TDAPA is helpful. It helps the business side say, yeah, we'd love to see doctors use this. It helps with access. For us, it's not the be-all, end-all. You'll have some products that are TDAPA products that there's no money in the bundle. It's kind of a two-year play and then what? We don't have that. We've never approached it that way because anemia, we're fortunate that anemia has a significant number of dollars in the bundle. I wish it was more, but it's enough for us to have a very successful business. I'm not sure what you've said about this before, but in terms of needing to adjust your price or post TDAPA, what's your thoughts around that? Yeah, we've talked about this publicly. Honestly, dialysis providers aren't going to use your product, whatever their spread might be, if they have to stop using it after TDAPA. It's a terrible look for them. It's terrible to give patients a drug and then have to take it away from them. In order to put the contracts in place that we did, and we had virtually every dialysis provider under contract when we launched in January, you had to assure them either contractually or through your discussions that they were going to have a price that's consistent with their ESA price today. Knowing that they were going to be able to have that lower price, they were willing to utilize the product upfront and happy to take the margin that TDAPA allows them. Yeah. Just to reiterate what John said earlier, even at that current standard of care pricing, this is a billion-dollar market opportunity in the U.S. Right. Now going back to the clinical side, you mentioned VOICE and VOCAL. Maybe just talk about those trials and what you hope to show and the impact it could have. Yeah. When you think about becoming standard of care, you become standard of care by continuing to deliver evidence of differentiation, right? I mean, EPO, EPOGEN, I was an EPOGEN sales rep at Amgen in 1991. It's been around a long, long time, right? I really believe that using this HIF mechanism is differentiated. It is going to get you a different outcome for patients. And the Churchow data that was presented last week that I just referenced is a great first step. Now, the VOICE study with Jeff Block at U.S. Renal Care is running. It's a collaborative study. He's now adopted that endpoint as his primary endpoint. That win odds analysis of all-cause hospitalization, all-cause mortality. That data will read out early in 2027. Last patient was enrolled in June. It's 18 months treatment for the last patient. Last patient comes out in December of next year and will read out quickly. We had a meeting with him talking about how quickly can we get the data analyzed and out. Now, VOICE is a smaller study. It's about a 350-patient study that we're doing with DaVita. Both of these studies are TIW dosing studies also, right? The idea is that this is really where treatment's going to go. The more interesting thing about VOICE is the sub-study that we're doing in just about 30 patients, but it's looking at red blood cell differentiation. We're taking red blood cells at baseline from patients in both groups and it's got an active ESA control, Darbepoetin control. We're looking at the changes in red blood cell over the time of treatment. We're looking at a number of things like capacity to carry hemoglobin, permeability, how it moves through the capillaries, all of these proteomics and all of these, a variety of things. It's this idea that you're not just increasing hemoglobin. You're doing it in a different way. We talk about this being a more physiologic way to manage anemia. You're getting a more physiologic red blood cell. There have been publications out of China earlier about HIFs, not with Vafseo, but with others that show your lifespan of the red blood cell, it lasts instead of 90 days, 120 days, right? It's a different way to do it. I think this is going to be really meaningful to physicians before they see the outcomes data to say, yes, I really believe that I'm doing this for a reason. There's a different, it is more physiologic way to manage patients. And seeing this red blood cell data, I think it's going to be really exciting. It's deep science, but it's the kind of thing nephrologists can latch onto and say, yeah, there's a difference in how I'm managing anemia here. I want to move more of my patients to that and to have that coincide with the end of TDAPA where all the patients can access the product. Because during TDAPA at the higher price, not every patient has access to TDAPA. That's how we'll grow the market. We'll be at a lower price, but we're generating clinical data to differentiate and having access to a bigger group of patients. Okay. We have a few minutes left here. I do want to, you have some other stuff in the pipeline. So just maybe briefly sort of key things to be aware of on these assets. It is early days on the pipeline and I think we'll be talking more about it. We had been planning on doing a larger study in the non-dialysis population. Meeting with the FDA a couple of weeks ago, it became clear that for the broad non-dialysis population, we were not going to align on the study that would make sense. We are going to keep engaging them on smaller sub-populations. They were quite engaged in that. We believe the drug, I mean, heck, every doctor I talk to wants to use it in the CKD population. We want to do what we can to help enable that. Now that frees up some of our resources to look at other things in our pipeline. A couple of things we've talked about, we have AKB-9090. These are very early stage. 9090 is another HIF-PHI that we expect to start a phase one study in the first part of next year. Our target indication is acute kidney injury. High, high, high unmet medical need. The HIF mechanism, we think it kind of hits this AKI from multiple different pathways. We think it can really be an interesting product in a very, very high unmet need space. The other product that is a little further behind is AKB-10108. This is outside of kidney disease, but it's another HIF-PHI. The target population is retinopathy of prematurity. Your retina only starts to develop at 24 weeks. Babies born prematurely, you go out of the anaerobic environment of the womb to the 100% oxygen environment, your retina stops growing. It's a leading cause of blindness in premature babies. Similarly, with your lungs, you get this bronchopulmonary dysplasia where the lungs do not develop effectively. ROP is, we think, is the first indication. This is a little bit further behind. The idea is basically this is all about oxygen. These HIFs are all about oxygen. I guess the layman's way of saying it, fooling that little baby into believing that they are still in the womb, allowing that retina to grow normally could be quite an amazing thing. It is an orphan population. We are excited about that. We have other assets that we have not talked about a lot that kind of watch the space. I think we will be talking about them soon. Okay. Maybe last question, just quickly, just your cash position here and how to think about that. Yeah. So we have a solid balance sheet. We ended the quarter with $166 million on the balance sheet. We've guided that we're financed to profitability. And that guidance takes into account the revenues from Vafseo and Auryxia, as well as the expense related to advancing the pipeline. Yep. Okay. All right. Great. Thanks so much for joining us. We will continue to look forward to the progress here. Thanks, John. Thank you. Appreciate it.