...the equity research team here at Canaccord Genuity. I have the pleasure of having Akebia Therapeutics with me this morning. From Akebia is John Butler, Chief Executive Officer. Akebia is developing and commercializing compounds to address issues related to kidney disease, and the company has two approved programs, one, which we'll launch in January. I don't want to steal too much of the thunder here, so I will turn it over to John, and if there's a little bit of time left, we'll have some Q&A. Thank you. Edward, thank you so much, and we really appreciate the opportunity to present today. It's always a pleasure to have the opportunity to talk about Akebia. We're a company, as Edward said, that is really quite focused on bringing benefit to patients with kidney disease. And you know, we're very, very excited that we have a new product that we'll be launching shortly. I'm just going to remind everyone that I'm going to be making forward-looking statements, so please refer to our SEC filings for more information. I think Akebia truly is a unique company with two commercial products, Vafseo, which is the product that was just approved, which I think we'll spend probably 90%+ of the presentation talking about. Auryxia is an important product to the company as well, and while it's moving towards the end of its life cycle, it's still an incredibly important product at about $170 million in revenue, just over that. Last year, we expect to be in line with that number again this year. It's been critically important to the company. It and it gave us the foundation, the commercial foundation in kidney disease. We have a commercial organization in place because they're promoting Auryxia, and that commercial organization has developed relationships in the dialysis space that will truly benefit Vafseo, which will drive much of our growth. We also have early-stage HIF pipeline, 2 products in preclinical development. I just don't think we'll have a lot of time to talk about those today, but they're, we're incredibly excited about them as well. So let's talk about Vafseo or vadadustat. Vafseo is indicated to treat anemia due to chronic kidney disease in patients who've been receiving dialysis for at least three months. That's the FDA indication for the product. This is a hypoxia-inducible factor prolyl hydroxylase inhibitor or HIF activator we also call that. This is based on Nobel Prize-winning science. I mean, this is extremely exciting science, a completely different way of managing anemia, and this is what truly has physicians excited about using the product in the U.S. It's really the U.S. that's going to drive our growth for the company. The product is approved in 37 countries. Our partner, Medice, has launched now in Germany, Austria, and the Netherlands, and will continue to roll the product out across Europe. And our partner, Mitsubishi Tanabe, has launched the product for a number of years now in Japan. But we're focused squarely on making this product a success in the U.S., and this is a very significant market opportunity. The anemia management in dialysis patients is an incredibly important part of the overall management of dialysis patients. There's about 540,000 dialysis patients in the U.S. 90% or so need to be treated for anemia. So say about 500,000 patients who are being treated today, and that represents about a billion-dollar market opportunity today in dialysis. So as we think about launching Vafseo, we think about ultimately having this product become a new oral standard of care for patients with anemia on dialysis. So what do we have to do in the launch to get there? Well, there's three legs to the stool, and we'll talk about each of them this morning. First is sort of mom and apple pie. We've got to drive demand from prescribers. They're excited about, about using the product. We've got to continue to drive that, drive that awareness, you know, get physicians ready to write. But this is dialysis, and dialysis is a very unique market with a unique reimbursement system, and drugs for anemia are covered as part of the dialysis bundle. We'll talk a lot about, you know, how we are approaching that, and it creates a real opportunity for Vafseo. But we have to contract effectively with the dialysis providers. The physicians want to write it, and it's not available through the dialysis providers, they won't be able to access it. So if we have a great contract, but the physicians don't want to write it, we won't sell any Vafseo. We've got to do both of those successfully in order to drive the launch. And third, you can't lose sight of the fact that we need to continue to deliver new clinical data. We have to show additional benefits for the product, particularly as we move through the reimbursement process, this initial TDAPA reimbursement, where there's payment outside of the bundle into the fully capitated, bundled payment. We have to continue to give physicians reason to want to use the product and expand their use of the product. But they really do want to use the product today, and it, it's really driven by this more physiologic approach to managing anemia. Physicians have been using erythropoiesis-stimulating agents or ESAs since 1990. They're comfortable with them, they know how they work. But what they know they're doing is they're giving a super physiologic dose of protein. You're seeing a big spike in EPO because that's what you're delivering to patients, and then it drops over time. And this leads to a very quick rise in hemoglobin, overshoots above the target range. A lot of work for the physician to manage the dose to keep people in the target range. What Vafseo does is a more physiologic approach. When our kidneys work, effectively, we are always making hypoxia-inducible factor, and there are enzymes called prolyl hydroxylases that are always destroying it. When patients' kidneys fail, they're not able to make EPO, but they're still making HIF. And we can stimulate that HIF to become the transcription factor that turns on the genes for making EPO, making red blood cells. So you see this very modest increase in EPO levels. You see this very gradual increase in hemoglobin levels for most patients. You're able to maintain that hemoglobin in the target range. You have fewer dose titrations with Vafseo. It's easier for physicians to use, is the feedback we get from physicians, and this is what they want. This is what physicians are looking for, and they're excited about HIF. 85% of physicians in recent market research had an unaided awareness of the HIF class. So, they know about the product. They want to prescribe the product. This 52% expect to prescribe a HIF. This was in April. We had our approval at the end of March. Our sales reps hadn't even started talking about the product yet. You know, this is the wonderful thing about having time between approval and launch, where we have to do our contracting. You also have the opportunity to really get physicians excited about using the product so that we can release that spring and have a strong launch come January. Physicians are growing in their awareness of the product, as well as just the class of drugs as well, and we'll continue to grow that number over the course of the year. When you ask them, "What are the things we need for anemia management?" They want an oral drug. Vafseo is an oral drug. They want this physiologic effect. Anytime a physician can use a drug that is a more physiologic way of achieving a treatment goal, that's something that they gravitate towards. They want to be able to maintain hemoglobin in the target range. There's safety risks when hemoglobins go above the target range of 10-11, and this is where physicians start to be concerned, and it's where they have to spend a lot of time in patient management, managing that ESA dose. Being able to gradually bring hemoglobin into the range and keep it there is something that they're really looking for, and, you know, we believe that Vafseo has the opportunity to deliver it. Now, as I said, we want to move towards a standard of care, ultimately, but anytime you see adoption of a product in a new space, you have areas where do physicians want to use the drug first? There are two areas that continue to rise to the top for physicians. Home patients, which is about 80,000 patients, and it's the fastest-growing segment of the dialysis market. This makes sense. We have a once-a-day oral product. Today, home patients have to come into the dialysis center once or even twice a month to get a shot of an ESA, and that's inconvenient for the patient. Allowing them to stay home, writing them a prescription, and delivering the product once a day as an oral product makes a ton of sense there. The other area that physicians are focused on are patients who are on the highest doses of ESAs. There's clearly physicians understand, and we saw it in our clinical trials, and it's been seen routinely, that as you increase dose of ESAs, you increase cardiovascular risk as well. So physicians are always more concerned when patients are on highest doses. We know that about 25% of patients are not in the target range for hemoglobin, and those are usually the patients who are on the highest doses of ESAs. That's where physicians want to use Vafseo initially. They also happen to be the most expensive patients for dialysis organizations because they're on the highest doses of ESAs. So that's about 150,000 patients, depending on how you cut off the high dose. So there's over 200,000 patients that are in the initial target that physicians are thinking about using the drug. So physicians are thinking about using the drug. They want to use it. We have to make sure they have access to it, and that means contracting effectively. You know, here's an area where our current product, Auryxia, is incredibly valuable to the company as we move towards contracting with dialysis providers. It just so happens that phosphate binders, which is the class of product for Auryxia, are also entering the dialysis bundle in January of next year, and they have a Transitional Drug Add-on Payment Adjustment or TDAPA period also. So dialysis providers have to contract for phosphate binders. They have to contract for Auryxia, so they have to talk to us about that product. As they're talking to us about Auryxia, we have the opportunity to contract with Vafseo as well, and we can make a very attractive contract for them. But you have to have in dialysis... It's a lot of work for a dialysis organization to add a new product to formulary, to create protocols, to allow access to that. There has to be a revenue opportunity for them in that, and that's why we'll be doing contracting with the dialysis providers. The contracts will be—they'll include an off-invoice component, and then they'll have a volume discount. The more, it's not surprising, the more Vafseo they use, the lower the price will be. And given that they have this opportunity to bill for Vafseo outside of the dialysis bundle, they will have the opportunity to have a margin on the product itself during TDAPA, and they avoid the cost of buying the ESA, which is on average about $16 per dialysis session today. So they have the cost savings of the cost avoidance, and they have margin. So there's a great economic incentive for dialysis providers to allow physicians to use the product. We drive the demand from the physicians, they make the product available, and that's where we have the opportunity to move towards standard of care. So, you know, we set the WAC price for the product just over about $15,500 per year per patient. No one will pay that price because all of these patients are under contracts at the dialysis provider. So we'll have that off- invoice price, and then the price will be lower as we drive volume through the system. So a simple way to think about it, we need to add a line to the slide that shows increasing volume. But as volume increases, our price will decrease, but we'll be incredibly successful with the product as we build that volume. And that's kind of where we're going. So think about that pricing during the TDAPA period is a premium pricing opportunity. Once TDAPA ends, and TDAPA is a two-year time period, after that, then the drug goes into the dialysis bundle. Well, the dialysis bundle has about $16 as a part of it. That's the cost of ESAs today. So what we'll have to do is bring our pricing down to that, let's call it $2,500 a year per patient. We'll be able to access, those all of the patient population, at that point in time. So this is a billion-dollar market opportunity today. So we have a premium price during TDAPA as we build experience with the product. And then as we continue to work to drive towards standard of care, we have to price and give the dialysis providers that confidence and surety around the price that they're gonna pay, and that happens in the beginning of 2027. So now we've gotten to that point. We have. You know, they're focused on home patients, they're focused on high-dose ESA patients. We need to continue to drive data to demonstrate the benefits of a new way of managing anemia. We have a very robust set of data today, including our Phase III program, which is published in the New England Journal. We have a wonderful paper in the Journal of Hematology on the mechanism, and it really shows the differences in how Vafseo drives increasing hemoglobin. But we have to work collaboratively with the dialysis providers to continue to generate new data. That is an absolutely critical leg of the stool. You're also then taking the opportunity to put the drug in the hands of hundreds, hopefully, of investigators who will become comfortable using the drugs and continue to think about ways to expand their use. But the focus of this collaborative research is really to fill data gaps, drive, you know, opportunities. Opportunities to show that you're doing something to improve patient care and patient outcomes, but ideally, also lower cost for the dialysis provider. So that's something we're actively working on and look forward to to talking more in more detail at future presentations about the studies that we're planning. So we're incredibly busy. You know, our perspective is we've launched the product. We simply don't make it available until we receive that TDAPA designation in January. We had the approval, we filed for TDAPA, we announced our WAC price. Our TDAPA submission was accepted by CMS. They will assign a HCPCS code in October, which they'll then communicate to the dialysis providers, so they'll know what they how they'll bill for the product. And then January one, you receive your TDAPA designation, we'll be shipping product shortly after that, and we're incredibly excited about that. We're in the contracting process now. A few weeks ago, we announced the first large dialysis provider contract for Auryxia. We've now expanded that conversation to include Vafseo. We are having Vafseo and Auryxia conversations with dialysis providers today that represent over 90% of the patients on dialysis. So our expectation is that we'll have those contracts in place by January first to be ready for the product introduction in dialysis. But, you know, we're also incredibly excited about opportunities to build Vafseo beyond dialysis. This is a billion-dollar opportunity, it's one that will, you know, be incredibly important for the company. But we've always considered non-dialysis as incredibly important area and an area of very high unmet need for patients as well. When we got the complete response letter around non-dialysis from FDA, they welcomed us back to discuss a clinical program for the patients where the benefit risk is positive. And FDA has, in multiple advisory committee meetings, talked about how there's a significant unmet need for poor patients who are not yet on dialysis, who have anemia. Here's data on this slide that it really shows these are patients who have GFRs below 15, so they're clearly pre-dialysis patients. They're transitioning to dialysis. And if they're not treated, if their anemia is not treated, they do very, very poorly. Their mortality rate is higher when they start, their mortality rate is higher 12 months later. In other words, you don't catch up. You know, if you're not treated well before you get to dialysis-... You don't do better, even though their anemia is being treated during dialysis. So you need to intervene with these patients, and it's simply not happening today. Even though ESAs are available for these patients, about 74% of patients were not treated prior to initiating hemodialysis. It's an injectable product, it's difficult to get, there's insurance concerns, patients don't want to go to the infusion center. Vafseo is a once-a-day oral product. In this population, it can make a significant difference for patients. And from a, when you think about our pricing, and the fact that, non-dialysis would be a more standard pharma, Part D commercial payer mix, the revenue opportunity is significant. If you simply look at Stage 4 and 5 patients, that's about 500,000 patients there as well. And as we saw, this is more of a blue ocean. Most of these patients are not being treated today. And, you know, when I talk to physicians, and I've spent a lot of time since launch talking to physicians individually, we'll talk about where they want to use the drug in dialysis. As I reflected, they're excited about using the drug in dialysis. Every single one, every single one, at the end of that conversation will say, "But you know where I really want to use it? Is in my CKD non-dialysis patients." And I say, "Well, we're still working on that." And we are, and we're working on a protocol today that we wanna discuss with the FDA. We have an expectation that we'll have feedback from the FDA by the end of this year, and we will move as quickly as possible. As I said, we expect that we will have to do clinical work to get there, but you can see that the opportunity for both the benefit for patients as well as for Akebia is really quite significant. A couple of other areas that we expect to expand the label. In the indication now, as you heard me say early in the presentation, patients have to be on dialysis for at least three months to be within the labeled indication. We were surprised by this kind of at the last minute from the FDA. We didn't agree with that, but we, you know, obviously took the approval, but we wanna go back and engage the FDA. In our non-dialysis program, we had 1000 patients who transitioned to dialysis during the study. So we have very, very good data on a very robust number of patients and see that there's no difference in MACE outcomes and cardiovascular safety when you start dialysis on vadadustat versus an ESA. So, you know, we're quite confident that we can have that language changed in our label, but we have clearly prioritized our discussions with FDA around non-dialysis. So we'll have this conversation with them, with the FDA next year, but this year we want to focus on NDD. But, you know, we've presented this data. We presented it at the dialysis conference in January. We're working to publish the data as well. So clinicians are gonna be aware of the safety data that exists for starting patients on Vafseo, starting dialysis for patients on Vafseo. The other area is the dosing opportunity. We have once-a-day oral dosing in our label. Physicians frequently on dialysis, patients who are in-center, they want to be able to deliver the drug to them while they're on dialysis and dose it three times a week. And a lot of the conversations we're having today, it's exactly what they want to do, particularly for those high-dose ESA patients who are in-center. Home patients, once a day, no problem. Some physicians want ESA out of the dialysis center and want to use it once a day for everyone. Some want to use it three times a week. Recognizing this, we did a study called FO2CUS, where we showed that you could manage anemia very effectively with three times weekly dosing of Vafseo. You look at the efficacy compared to ESAs. In this case, it was Mircera that was the comparator, and we were able to maintain hemoglobins within the target range incredibly well. The graph on the right is really quite important also. This shows ESA rescue, and ESA rescue is defined by if you had to increase your dose of Mircera by more than what's in the label, which is a 25% increase. So if they increased it 50% or 100%, it was about half the dose adjustments, half the ESA rescues for Vafseo versus Mircera. This is that idea that it's easier for physicians to use it. They get them into the range, they can keep people in the range. So we're gonna, again, engage with the FDA early next year on this opportunity, but we've presented this data at the ASN meeting last year, and we are working on getting this data published, and certainly our medical folks are discussing it with dialysis providers today. So a lot of work still to do on Vafseo and a tremendous amount of value for the company. You know, that's, that's to come here in the very near term. In the longer term, you know, we have our early-stage pipeline, two molecules. One is our acute care molecule that we're looking at in acute kidney injury and ARDS. We expect that to enter the clinic next year. A little longer out is AKB-10108, which is targeting pediatric rare pediatric diseases in neonates. Retinopathy of prematurity would be the first indication, at least that's our expectation. Super excited about that, about that program, and look forward to talking more about it later. We're doing all of this from a position of financial strength. We just reported about $40 million of cash on the balance sheet. Remember, we have $170 million in revenue on Auryxia last year. We expect to be in range, in line with that number, this year as well. We have been incredibly disciplined about spending while investing appropriately for the launch of Vafseo. We are very disciplined in how we're spending our cash, and, you know, we believe that our cash and cash from operations will fund our operations for at least the next two years. So we have a busy year ahead of us. As I've said, we're driving demand, we're contracting effectively, we're working on new clinical programs. We're very, very focused on a successful Vafseo launch. Thank you for your time and attention.