Okay, we're welcome back, everyone, to HC Wainwright's Global Investment Conference. My name is Matthew Caulfield, I'm a Senior Biotech Analyst here at HC Wainwright. We're very grateful to be joined by Akebia Therapeutics, and I welcome Nick Grund, Chief Commercial Officer, and also Erik Ostrowski, CFO, Chief Business Officer. Thank you both very much for being here. Thank you for having us. Thank you. The commercial platform is really focused on Vafseo for treating anemia due to chronic kidney disease and receiving dialysis, and Auryxia focused on the hyperphosphatemia indication. For those investors newer to the Akebia story, can you share your views on the current commercial priorities? Yeah, no, absolutely. As you mentioned, Akebia Therapeutics is focused on helping patients with kidney disease, two commercial products. Auryxia is a phosphate binder. It's been on the market for several years now. Last IP exclusivity in March, yet generating $47 million in revenue in Q2. It's been really a fabulous product for us. Our focus today, though, is more so on our new product, Vafseo, which is a treatment for anemia caused by CKD in patients on dialysis. We really believe this can become a new standard of care. This product launched in January of this year. Q2 generated over $13 million in revenues from Vafseo, so the launch is off to a really good start, and I look forward to sharing more of those details with you today. Excellent, thank you for that. One important focus for this year has been utilization of mid-sized dialysis organizations that you're broadening to the larger dialysis organizations or LDOs, offering operationalized protocols. How would you characterize the prescription progress for the year with impact both from refills and titrated dosing? Yeah, that's a whole bunch of questions in one. If we start, we look at Q2, really successful, over $13 million in revenue, 55% demand growth. When we think about that 55% demand growth, it really is coming from two buckets. The first is breadth and depth of prescribing. So 725 prescribers at an average prescription of 13 prescriptions each. There are the US Renal Care doctors in there. Of the 40,000 addressable patients that we have, 36,000 of them are within the US Renal Care Network. When we think about breadth and depth, over 80% of US Renal Care physicians have prescribed Vafseo. Good penetration in that market. Over 80% of the clinics have used Vafseo, so that is widely spread amongst their clinics as well. More room to grow there. At 13 prescriptions each, we think there's more room to grow there. Pleased with what we've seen thus far. When you think about dose, if you will, the starting dose of Vafseo is 300 milligrams. It's a QD therapy, 300 milligrams once a day. In our Innovate trial, we saw doses approximating about 430 milligrams in dose, so about a 45% increase over the starting dose. We're seeing that being replicated in the refills that we're seeing coming through the prescriptions, which is great. Real world was actually approximating your trial. Who would have thought? That dose increase is really comforting to see. It generates more volume for us. About 80% of our prescriptions in Q2 were refills, and that dosing is having an impact on that overall 55% demand. Very helpful. Near-term growth includes the DaVita clinics and their operational pilot, ultimately leading to access to roughly 200,000 additional patients. There are both the dialysis clinics and Innovative Renal Care dialysis organizations expected to have operationalized protocols with access to an additional 32,000 patients approximately. Can you talk a bit more about how these plans are progressing and their related timeframes? Yeah, absolutely. Let's start with Innovative Renal Care. I have to say they have the fifth largest dialysis organization in the U.S. They have roughly 16,000 patients. They have operationalized their protocol. What operationalizing their protocol means is they've certainly published it. They have the system set up to allow physicians to use it, and physicians are writing. That operationalized right in the middle of August, and good progress there thus far. The second is Dialysis Clinic Inc. Dialysis Clinic Inc. also has 16,000 patients, but the fifth largest dialysis organization in the U.S. That protocol we're expecting to hit by the end of the quarter. Those two together are about this 32,000 that you referenced. The more important, frankly, new start is the DaVita pilot. This is an operational pilot to test to make sure that their systems are working. Can a physician enter into their EMR? Do they check the reimbursement to make sure the appropriate reimbursed patients go on therapy? Does the patient get that product shipped to their home? Do they get a refill? We'll call it the real blocking and tackling. These large dialysis organizations really do nothing without piloting first. That pilot's off in over 100 clinics. To put that in terms of size, that would make them the sixth largest dialysis organization, just the pilot alone. The pilot can sometimes mean a onesie-twosie. It's not a onesie-twosie. This is a one of size. When we think about that, it's about three months in length. We'll call it middle of the fourth quarter, we're saying by year-end, once that pilot's successful, they'll open it up to their 204,000 patients for physicians to prescribe to. We're super excited about that. Yeah, absolutely. Along those lines, how would you further characterize the overall market opportunity for accessing anemic chronic kidney disease patients that are on dialysis? When we think about that, you know, that 275 is out of total anemic patient population of roughly 550,000 patients. Fresenius is the other one out there that we want to get. We're in constant dialogue with Fresenius about data and evidence. We have several things at ASN that we're going to be presenting on that they're interested in. Is it going to happen in 2025? Doubtful. We believe we can get in front of their P&T committee in 2026. Right. That's great. I mean, it's important for investors to understand these aren't clinical trials. This is a protocol adoption essentially, which is sort of unique to this dialysis organization space. That's correct. One interesting point looking back to Auryxia is that this past quarter demonstrated 15% year-over-year growth despite having lost the IP exclusivity that you mentioned, the previously authorized generic, and, you know, conservative expectations for Auryxia's continued contribution to the top line. Can you share your views on Auryxia and the focus on Vafseo growth moving forward? Yeah, Auryxia is a really unique product. You know, it's been in the marketplace roughly 10 years. Right. The clinical profile is well understood. Physicians have always wanted to use the product. It's an iron-based binder, so clinically, it's been strong. It has always suffered from lack of access. Surprisingly enough, TDAPA has actually created more access for it. When you think about a great clinical profile, physicians' willingness to use, and then you think about the economics sitting behind TDAPA, our contracting story for Auryxia was very similar to what we've seen for Vafseo. That economic incentive, along with its clinical value, has created great momentum for Auryxia. Unfortunately, we could wake up tomorrow and it could not be around any longer, or at least another generic could enter. We plan pretty conservatively about it. Understood. Turning back to Vafseo, appreciating the nuances for treating chronic kidney disease, particularly in navigating utilization by the larger dialysis centers, what are the main considerations influencing Vafseo's commercial expansion into 2026 and even beyond? It's really just about expanding to the LDOs and beyond that? Yeah, I mean, in order to become standard of care, you kind of have to generate data, right? As we think about the VACE trial, for example, that we're doing in partnership with US Renal Care and Dr. Block, that's a study that's powered to show statistical significance in hospitalization and mortality. Hospitalization is good for patients, right? There's also an economic piece of hospitalization. D.O.s are on the hook for a portion of that hospitalization care. When you think about the average dialysis patient that's hospitalized two times a year at an average cost of $60,000 per hospitalization, that's $120,000 of cost. You show a 10% reduction in hospitalization, that's $12,000 per patient per year. That's substantial. They're also out of the chair on average four to six times per year due to these hospitalizations. They're not collecting the $274 for that patient being in the chair that session. It may not sound significant, but you do some math on $274 times 152 treatments a year times 550,000 dialysis patients, that's a big lost revenue opportunity in terms of the economics for a dialysis organization. If we can prove through the VACE trial around hospitalization and mortality, we do think that's another leg of the stool to continue to generate evidence supporting the use of the product. Understood. Kind of along those lines, what factors do you think can influence Vafseo utilization in dialysis centers versus being used for home use? What do you believe could define the greatest growth for patient access to therapy and deeper patient penetration? Yeah, when we originally launched, we had thought physicians would have two profiles in their mind for use. One, the home population is very clear, right? Sure. They don't have to go in for additional lab tests or injections during the period, or some patients who are self-injecting don't have to self-inject. You know, Vafseo's profile is really clear there. 80,000 PD or home patients in the U.S. out of the 550,000 patients. The other population between 125,000 and 150,000 patients are high-dose ESA patients. These are folks that are on higher doses of ESAs to control their hemoglobin. With higher doses of ESAs comes cardiovascular complications and risk. Those populations also happen to cost the dialysis organizations the most money. Those populations tend to be where we thought they were going to be first movers. We were pleasantly surprised to see broad usage. Within the US Renal Care, for example, we're not seeing a niching of the product to those two populations. We're seeing very broad usage. When we start other dialysis organizations, we may see that going back to where they might think of using it. Thus far, I'm pleased with its broad usage. Excellent. I think it's also important to point out that you're planning to initiate the Phase 3 VALOR trial by the end of this year that's evaluating Vafseo in anemia late-stage CKD patients that are not on dialysis. What is important for investors to appreciate about the non-dialysis market opportunity? Yeah, when we think about that opportunity, and I hate to say it this way, but whenever I'm out with sales reps, yes, they want to use it in dialysis, and yes, there's interest, but about, I don't know, 80 seconds into the conversation, they ask me when they're going to have it in non-dialysis. The question is, is why, right? I think that's the point of your question is, when you think about that patient population, CKD 3, 4, 5 patients, there are anemic patients in that population, similar to what you see in dialysis, around 500,000 or so patients. ESA usage has gone down over time. Five years ago, 50% of folks that were anemic in that pre-dialysis population were treated with an ESA. Today, it's less than 30%. The question is, is why? If there is a need, why aren't they being treated? ESAs are really insured as a rescue therapy. Generally, you can't treat with an ESA without having to jump through the hoop that's on fire to get it until the hemoglobin drops below 10. What you see is a patient starts, their hemoglobin is below 10, they get a dose of ESA, there's a super physiological spike, it starts to come down, goes below 10 again, they get another super physiological spike, comes down, et cetera, et cetera. That's called hemoglobin cycling. Hemoglobin cycling has been correlated with adverse outcomes too. When you think about a physician, they don't really want to do that. They think it's almost better not to treat than to put their patient through that. What you see is often ESAs are being initiated when the hemoglobin is at nine or even eight. In some cases, those patients are so low, they get a blood transfusion. If you get a blood transfusion, you're actually not eligible for a transplant for 90 days. You're also building antibodies that may prohibit you getting a match permanently. If you're a dialysis patient and you're a non-dialysis patient and you're progressing towards dialysis, transplant is your hope that you don't have to go on dialysis. If you miss that phone call or even if that phone call comes and we found a match, oh, you had a blood transfusion in the last 90 days, sorry, we're going to skip you and you can wait around for the next match. From a patient care perspective, that's really, really disheartening. We think Vafseo offers the opportunity to treat more normally with small hemoglobin action and being able to avoid the complications of blood transfusion. Yeah, and from a financial point of view, this is a significant market opportunity. As Nick mentioned, about the same number of patients in this non-dialysis segment as there is on dialysis, but the payer profile is much different. You're looking at your more typical private pay, non-bundled government pay. We see this as a multi-billion dollar opportunity. In terms of our trial plans, we're looking to start a Phase 3 trial, which we call VALOR. This would be a cardiovascular outcome study, about 1,500 patients in the U.S. We are engaging with FDA on this trial. We had a Type D meeting. We've requested a Type C meeting, and our plan is to finalize the protocol based on feedback and start the trial by the end of this year. Very exciting. I mean, you mentioned the kind of the sales conversations you've had. Do you feel the kidney specialist receptivity is as strong for the demand for non-dialysis patient therapy? I think it's even stronger. Yeah, very helpful. Looking to a future that could have commercial Vafseo penetration in both dialysis and non-dialysis anemia CKD patients, do you foresee one of those patient populations being the greater contributor to the bottom line ultimately? Obviously, there's some nuances between the two populations. Yeah, I think to be standard of care, you kind of have to have both, right? The opportunity is much larger in non-dialysis-dependent CKD, but you can imagine a world where instead of a patient coming onto dialysis being naive or on an ESA in this kind of rescue therapy mentality, they're coming on well controlled on Vafseo. There are a lot of studies out there that show if a patient's coming into dialysis with their anemia under control, they have far better outcomes than if their anemia is uncontrolled. The two actually may play well nicely together because of that consistency of therapy through non-dialysis to dialysis. Regarding the financial position, where do things stand on the current cash runway, and are there any related points on the very early pipeline that you'd like to share? Yeah, so you know we're in a really solid financial position. We ended the second quarter with $137 million in cash in the balance sheet. We've guided that refinance to profitability. When we look at that guidance, we take into account the revenues coming in. We also take into account the costs, including with the NDD trial that I talked about. We've got a lot on our plate, and first and foremost, we're focused on executing on the Vafseo launch in the U.S., getting the NDD trial started. We do have a very interesting pipeline behind those projects, including one in acute kidney injury, and we're bringing that into a phase 1 trial this year. A little bit further back, but a program we're really passionate about is AKB-10108. This is in retinopathy of prematurity. It's a rare disease. It's outside of renal, but it's one disease where we think our HIF biology really matches up nicely with that disease. We'll be looking to take that forward as well in due course. Very helpful. In our last minute or two here, what do you consider the most important near-term catalyst for investors to keep top of mind in the second half of 2025 and heading into 2026 and beyond? Yeah, I mean, I think the investor focus, you know, not surprisingly, is on the continued success of the Vafseo launch and, you know, revenue growth, and, you know, looking for those milestones that Nick laid out in terms of how we continue to expand that prescribing access for the product. Beyond that, you know, I think there's some focus as well on the NDD trial and getting that started by the end of the year. Very helpful. I mean, are there any sort of misconceptions or aspects of the platform that you feel are underappreciated by the market presently? Yeah, for me, I think it's, you know, this company has been around for a while. You know, like most biotechs, it's had its ups and downs, but I've come through in a really good spot today. I think this is really a transformational year for us. A lot of our investor engagement has been getting folks back up to speed on the company, the Vafseo launch, and the things we're looking to do. Sure, the commercial execution. Absolutely. Excellent. With that, thank you very much, everyone. Thank you to Akebia Therapeutics, Nick, and Erik. It's always great to see you guys. Thank you. Thank you.