Welcome to the Jefferies Global Healthcare Conference. My name is Ashwin Surapaneni, and I'm with the Healthcare Investment Banking team here. I'd like to introduce John Butler from Akebia Therapeutics. Thank you.
Thank you very much. It's a pleasure to be here. Thanks to the Jefferies folks for the invitation. I really am excited to have the opportunity to talk to you today about Akebia. We are at a very interesting time, an exciting time as a company. We're a company that is, is really a purpose-driven company. Its purpose is to better the lives of people living with kidney disease. And, you know, what better way to get a group of people who are committed to a purpose, excited? What better way than having a new product to sell that you know can impact thousands and thousands of patients on dialysis? It's, it's an incredibly exciting time for the company, and I'm, I'm, I'm really excited to, to walk you through that.
I will remind you that I'm gonna be making forward-looking statements, so please, refer to our SEC filings, for more information. Akebia really is a very unique company. Again, we have this clear therapeutic focus on, kidney disease. We understand kidney disease, particularly dialysis. We have a commercial product already, that did about $170 million in revenue last year. We expect to grow, this year as well. I think the value of the company, is really focused on Vafseo, our new HIF stabilizer, for the treatment of anemia in patients with chronic kidney disease who are on dialysis. This is a very significant, commercial opportunity, and, you know, one that we'll spend most of the presentation talking about.
But we recognize that you have to be able to answer the question, "What's next?" And we also, with a very small discovery team, have moved two HIF-based compounds into preclinical development, the first of which we believe will be in the clinic next year. So, you know, we're our focus today is on making the Vafseo launch a successful launch, but we're also thinking about how do we continue to grow the company into the future. But let's talk about Vafseo. Again, this was a hard-fought battle to get the product approved in the US, and we're so excited to be there.
The tenacity that the team displayed in getting the product approved will be on display again as we work to make the product a success in the market. And it really is a unique product offering. This hypoxia-inducible factor prolyl hydroxylase inhibitor or HIF activator is based on Nobel Prize-winning science, and it really does approach managing anemia in a very different way than physicians are used to using the ESAs. It's a once-daily oral tablet. It activates a more physiologic response, and we're really going back to that kind of messaging with physicians to demonstrate why this will be a preferable way for them to manage anemia in their patients. With the US approval, the product's approved in 37 countries.
I'm very excited today to let everyone know that our partner, Medice, has introduced the product in Europe, in Germany and Austria, this week, as we had previously said we expected them to do. And so the product is now available. And that again is just so exciting that this product that we think makes such a difference for patients is available globally now as well. And Medice will continue to expand that introducing the product across Europe. But to be clear, for Akebia, driving a successful launch of Vafseo in the US is the single most important driver for the company in the near term.
And the foundation of doing that is that you need clinicians to want to use the product, want to change what they've been doing since 1990 in managing anemia. And what we see from physicians is that they are excited about a new opportunity. They know that 25% of their patients don't hit the target hemoglobin level, and that there's a new way of doing that. And, you know, these are just this slide, really just a couple of graphs to demonstrate the difference. With EPO, you're giving this super physiologic dose of the protein, and with that, you see excursions, you see hemoglobin cycling. You know, with Vafseo, you're giving a once-a-day oral product. You're stabilizing HIF, which allows EPO to be produced, a very small amount.
We can almost not even measure the amount of EPO that we're producing, yet you see this gradual increase in hemoglobin, and that's part of the real benefit for physicians. You're not seeing this quick increase in hemoglobin. You're seeing a gradual rise, and they maintain hemoglobin within the target range. You know, I was talking to an investigator from one of our three-times-weekly studies a few weeks ago, and he talked about, you know, with the ESAs, how he has the anemia managers always calling him. "Hemoglobin's gone too high. Hemoglobin's too low. We got to adjust the dose." He goes, "With vadadustat, Vafseo," he goes, "someone had a hemoglobin of 10.3, 10.4.
We switched them to 900 milligrams of Vafseo 3 times a week, and they simply stayed at that hemoglobin level." It was easy, easy for the physician, and that's what they want because once you see cycling of hemoglobin, this is when they start thinking about risk. So, you know, it is a very different way of managing anemia and one that I think physicians are quite interested in trying... But we're launching into dialysis, and launching into dialysis means you can't just think about, I just need physicians to wanna write the product. You have to think about the way drugs are accessed in dialysis. We are clearly positioning the product that we believe it can be a new oral standard of care for patients on dialysis.
Central to that is we have to drive that demand from prescribers. But you can drive demand all day and all night, and if you haven't contracted effectively, if you haven't created an environment for the dialysis providers, where they're willing to do the operational work to switch people, you're not going to be successful. You'll just frustrate the prescribers who can't get the drug. So, and then beyond that, you have to continue to support the product. You have to continue to develop data to show where the benefits lie. So we really look at these three initiatives are critical for us to do well in order to have a successful launch.
I'll talk a little bit about the unique reimbursement in dialysis as well, which has led us to make the decision that we're gonna introduce the product in January of next year once we secure this transitional drug add-on payment or TDAPA payment that really creates an opportunity for dialysis providers to utilize the product more broadly. So we have to drive that demand, we have to contract effectively with the dialysis providers, and we're deep in those conversations today, and we have to demonstrate additional benefits of the product, continue to allow the product to grow beyond just the launch phase, and to put the product in the hand of multiple potential prescribers in the near term.
I think that way of thinking really, you know, is just because we truly understand this dialysis market. You know, this is the fact that we already have a product in the market, Auryxia, which is $170 million in this past year, that our sales force has been in place promoting this product. Physicians know Akebia, they know our commitment to dialysis. Auryxia is moving into the bundle next year. We're negotiating contracts for Auryxia at the same time as Vafseo. All of these things really create great opportunities for us. We have the commercial team in place, but it's not just the commercial team we've just hired. They're people who truly understand dialysis and renal disease. I've been working in dialysis since 1991.
We have the relationships, we have the knowledge, we have the expertise, and I think that those are the things that are gonna help make us successful. We have partnerships that will also potentially improve access. You know, one of the most expensive things for a small company when they're launching a product is putting product on the shelf, is manufacturing product. We put the product on the shelf two years ago, when we were expecting to launch originally. We've done work to extend the dating of that product, so we don't have to spend significant money on building out a supply chain today. That product is ready to go as soon as we secure that TDAPA reimbursement. So this is a large market opportunity, a billion-dollar-plus US market opportunity.
Now, the great thing is, because anemia management is part of the dialysis bundle, all patients have access from day one. Any prescriber can get access to the product. It's not like we have to contract with Part D providers. There are about 540,000 CKD or dialysis patients. 90% of them are treated for anemia. So call it 500,000 patients who are treated for anemia. Now, CMS recognized that in a bundled payment environment, it's very hard for dialysis providers and physicians to try new products. How does that fit in within the cost structure of the dialysis organization? So they created this TDAPA reimbursement, this transitional drug add-on payment, and for two years, they will reimburse the dialysis providers on an ASP basis for drugs that have this TDAPA designation.
So in January, Vafseo gains this TDAPA designation. Dialysis providers will be able to bill for the product outside of the dialysis bundle. Remember, the cost of their ESAs today are part of the dialysis bundle. That bundle payment doesn't change. They simply get paid for Vafseo outside. So there's already an economic incentive for the dialysis providers to try a new product. If we contract effectively with them as well, they make that product more broadly accessible for patients. Now, we talk about 36%+ who have this enhanced access. 85% of dialysis patients are Medicare patients, but that's pretty much split between traditional fee-for-service and Medicare Advantage, and not all Medicare Advantage patients have access to TDAPA. The dialysis providers are negotiating those payments today. So that's why we talk about 36%+.
We think that's a growing portion of the population who will be able to access that additional payment. So it's a very, very open environment if we do the contracting work effectively to have the product adopted and used broadly. But we wanna have that reimbursement in place in order to make the product available, because you've only got those two years for TDAPA. You have to take advantage of those eight quarters where the dialysis providers can bill outside. So that's why we made the decision, even though we had approval at the end of March, that we would be filing for TDAPA this quarter, we'll file this month, and it takes CMS six months to give you that TDAPA designation. So January, we'll have the TDAPA designation. So what happens in the meantime?
Well, in the meantime, we do all of the work to prepare the market. Our sales force is out there today, talking to prescribers about Vafseo, driving that interest in prescribing. At the same time, we're doing the work on contracting with the dialysis organizations. We'll have those contracts in place by the time we receive that TDAPA designation. And they can't use any new product in the dialysis setting unless there's a protocol and a formulary for it. And so we've got to have our medical folks have to work on those protocols, and all of that will take these 6-9 months. And, you know, the idea here is that we will drive that demand from prescribing physicians, create that contracting environment that's favorable for the product.
But as you know, it's like tightening a spring, so that when the product's available in January, you know, we can unleash that demand, and that's the idea. So we'll file for TDAPA this month. We'll announce our WAC pricing this month. And you know, I'll talk a little bit more about our WAC pricing, but remember, this is contracted business. So we'll have a WAC price. Every dialysis provider will pay a lower price than WAC, because you know, there will be contracts with each of those. Those contracts will consist of an off invoice discount, but very importantly, they'll also have volume discounts.
So our net price will drop as our volume increases, but obviously, you know, that's what we're really working for, to become standard of care, hopefully during that TDAPA period. So it's a very, very busy time over the next 6 months, and we'll continue to update you on our progress in contracting, protocol development. And I talked about that—we talked about driving demand, contracting, and then driving new data, collaborating with the dialysis providers on a new study, putting the drug in the hands of a lot of prescribing physicians, with the goal of generating significant data that will allow us to continue to grow in the post-TDAPA period. We wanna start those studies before the TDAPA period initiates. So, the team, we consider ourselves launching the product today.
You know, we are driving all the things you need to do to make the product successful. The product simply won't be available in the market till January, 'cause you wanna use those 8 quarters of TDAPA to the greatest effect. And so, you know, we also think about we're driving towards standard of care, but anytime you introduce a new product, if physicians think about where do they wanna use the product first. And we think there are a couple of very easy places to think about where physicians are wanting to use the product. You know, I've spent some time out in the field with our reps, talking to physicians, and you know, you hear the excitement in their voices, and they talk about these patient populations as well.
I mean, it's part of our messaging, but we don't have to message around it. I mean, this is where they're seeing using the product. Home dialysis is a very straightforward area. There's about 80,000 home dialysis patients, and it's growing, continues to grow quickly. Well, this is a once-a-day oral product, ideal for the home population. They have to bring them in once or twice a month to get a shot of Mircera or ESA today. They'd rather not have to come into the dialysis center. They can manage them on an oral product. That would be ideal. The other area that they have the greatest concern is on the high ESA dose patients. There is a relationship that physicians understand between higher doses of ESAs and higher risk of MACE events.
It also happens that high ESA doses are the most expensive patients for dialysis providers. So the idea of switching those patients to an oral product to Vafseo, and sometimes they'll make the decision to dose the product three times a week in the dialysis center. Our label is for once day, but we've presented the three times weekly data at the ASN meeting. We're working on that publication. They seem very amenable to using it in the dialysis center. That will be up to the physician as well. But, you know, here you're talking about more than half of the dialysis population that are clear areas where physicians are looking to use or potentially start using the product.
We're highly focused on the launch, but we also recognize that there is a significant opportunity for the product outside of the dialysis population, and that's in the non-dialysis patient population. Once again, you know, you think about this is a once-a-day oral product. Today, in the non-dialysis patients, patients whose kidneys are failing, but they're not ready for dialysis yet, maybe a GFR below 15, more than 70% of those patients in the US do not get treated today. I'll be out with physicians who will be talking about dialysis, and they'll say, "Hey, but I really want to use this in CKD patients, in non-dialysis patients. Will I be able to?" And I say, "Well, the product's not available for CKD non-dialysis.
It's not in our label." They can, of course, use it wherever they wanna use it, but we need to drive to non-dialysis. Non-dialysis, we think it at least doubles the opportunity for us, and there's this clear unmet need. I mean, if you look at this, this is just an example of the kind of data that exists. If you compare patients who were treated with an ESA, had their anemia managed, versus patients who didn't, who started dialysis, mortality rate is higher for patients who aren't managed, when they start at three months, even 12 months later, after you've managed them with an ESA, they never catch up. So managing and having a healthier patient start dialysis is what physicians want, and that's why they wanna use the product here. And, as I said, you know, this really more than doubles the opportunity.
We've talked about the contracting that we have to do with the dialysis providers. As we think about WAC pricing, it's this population that really drives our thinking, because you only get to set initial price once. We price for this non-dialysis population. It actually creates more room for us also from an annual pricing perspective. So this is something we're very focused on as a team. FDA has agreed in, you know, ad comms on other HIF products that this non-dialysis patient population has a high unmet need. We want to engage with the FDA on a path forward.
We expect that we're gonna have to do some clinical work, but we expect to have an answer by the end of this year, and this is an opportunity I think that's not at all appreciated as a value driver for for Akebia. Incident dialysis patients. Our label says that that patients have to be on dialysis for three months before they should start on Vafseo. We disagree with that language. We presented data at the dialysis conference earlier this year that demonstrated that incident patients. We had 1,000 patients who who started dialysis on the PRO2TECT study, on our non-dialysis study, and they did just fine switching over. So this is another area that you know that we want to engage with the FDA on changing that language. And then I mentioned the dosing regimen as well.
Three times weekly dosing allows for, you know, clear compliance. They can hand the patient the pill in the dialysis chair. They control that, and that's what dialysis providers like. So, you know, we've again presented this data at the ASN last year. We're working on getting that published. We expect it to be published before we make the product available in January. And there are a lot of dialysis providers, their clinical folks who are making the decision that they will, based on that data, they'll use the product three times a week. But we wanna add this to our label as well. Just a quick note on Auryxia. Again, it's incredibly important that we have had this product.
I mean, this product has generated over $700 million of revenue for Akebia since the merger with Keryx back in -- end of 2018. It continues to be an important funder of the company's operations, and it's just changed the perception in the market of who Akebia is as we bring a second product, Vafseo, to the market. You know, we did $170 million last year. We expect to grow this year, probably modestly from that. Now, we lose exclusivity on Auryxia in March of next year. But interestingly, the dialysis phosphate binders are going into the dialysis bundle in January of next year. This has created a great opportunity for us from a contracting perspective.
We're contracting with all the dialysis providers on Auryxia, and we can talk about Vafseo at the same time. You know, this is really a great opportunity for us. It also. You know, the fact that for two years there'll be a TDAPA on this product, we think creates some upside opportunity for us, as well. So, you know, we do expect that Auryxia will still be an important part of who we are, as a company. And as I mentioned... Running out of time. As I mentioned, we're excited about our pipeline as well. It's much further in the distance. As we think about what are our priorities today, it's a successful Vafseo launch, driving that non-dialysis, you know, pathway in.
And then third is moving our preclinical assets into the clinic. We have an expertise in HIF that we're continuing to drive. It's a very small discovery organization who's been very mighty and has moved two products into preclinical development, all in acute care areas. Acute kidney injury for AKB-9090. We expect that to be in the clinic next year. I'm particularly excited about AKB-10108 for retinopathy of prematurity, a high, high unmet medical need. In the last couple of seconds here, on our strong cash position. You know, we had $42 million in the bank at the end of last quarter. As I said, we'll drive more than $170 million of Auryxia revenue this year. We've been extremely disciplined in our spending.
And while we're launching Vafseo, we have the organization in place, we have the product on the shelf. We don't expect a significant step up in operating expenses at all in 2024 or 2025. And, you know, we think that we have cash that will fund operations for at least the next two years. If our launch goes as expected, it will fund it for even longer. So, it's exciting days for Akebia. Thank you for listening this morning, and I look forward to continuing to update you on our progress over the course of the year. Thank you. Do we have time for questions?
Yeah.
Do we have any questions? I'm very excited that my presentation was so complete that there's no questions from the audience. Thank you.