Good day, and thank you for standing by. Welcome to Akebia conference call to discuss FDA approval. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you'll need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Mercedes Carrasco, Senior Director, Investor Relations and Corporate Communications. Please go ahead.
Thank you, and welcome to Akebia's conference call to discuss the approval of Vafseo vadadustat tablets. Please note that a press release was issued yesterday, Wednesday, March 27, and that release is available on the investor section of our website. For your convenience, a replay of today's call will be available on our website after we conclude. Joining me today, we have John Butler, Chief Executive Officer, Dr. Stephen Burke, Chief Medical Officer, and Nicholas Grund, Chief Commercial 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 press release that we issued on March 27th, as well as in the Risk Factors and Management's Discussion and Analysis section of our most recent annual report filed with the SEC. The forward-looking statements on this call speak only as to the original date of this call, and except as required by law, we do not undertake any obligation to update or revise any of these statements. With that, I'd like to introduce our CEO, John Butler.
Thanks, Mercedes, and thanks to all of you for joining us today. This is a very special moment for Akebia. To our current and former employees, our board members, consultants, partners, and advisors, I'm thinking of all of you, and I'm so grateful for the role you played in getting us to this day. But most significantly, this is a very important day for patients, as I can now announce the approval of Vafseo as a treatment for anemia due to chronic kidney disease in adults who've been receiving dialysis for at least three months. When we received the CRL for vadadustat almost two years ago, there were not many people who believed we would be here today. But this team at Akebia did believe. We believed in this product, and we believed in each other.
We're a purpose-driven company, driven by a desire to improve the lives of people impacted by kidney disease. We're also a company who lives by our values, such as commitment, transparency, collaboration, integrity, and tenacity. All of these were on full display over the past two years. It took an unrivaled display of tenacity to get to this day. We are also so fortunate to collaborate with outstanding partners like Mitsubishi Tanabe, our partner in Japan. They were incredibly gracious in supporting our team to generate the data needed for our NDA resubmission last September. I can't thank them enough for their partnership. Now, with an approval, the next question is: What about the label? We are pleased with the label and believe it will support a very successful launch.
Dr. Steven Burke, who led the team through the FDA process and who continues to identify opportunities to demonstrate Vafseo's potential benefit for patients, will review details of the label in just a moment. We recognize that an approval is just the first step. Now we have to execute a successful launch. May I say, if you were impressed by the tenacity and drive of our team that they demonstrated in getting the product approved, expect the same or more from our commercial and medical affairs efforts as we deliver on Vafseo's launch. Our ultimate goal is for Vafseo to be an oral standard of care for dialysis patients. We believe that we can achieve this if we do three things well. First, drive demand from prescribing physicians. Our research suggests prescribers are compelled by the unique Nobel Prize-winning mechanism behind Vafseo.
We need to harness that perspective into a desire to prescribe. Second, we must effectively contract with dialysis providers to deliver on the value opportunity created by CMS for new innovations through the TDAPA reimbursement. Dialysis is a unique business. We understand that, and we understand that we have to approach our launch with those unique dynamics in mind in order to be successful. Finally, third, we have to continue to generate clinical data to identify additional areas of potential benefit for patients. Demonstrating that commitment to our product, as well as the providers, prescribers, and patients, is critical to our long-term success. We are a part of this community. On this call, you'll hear from our new Chief Commercial Officer, Nick Grund, who'll outline the plan for the launch of Vafseo, and we will provide timelines associated with key milestones.
He'll talk about the efforts that we believe will shape the market for a successful launch upon TDAPA designation. For now, I'd like to turn the call over to Dr. Stephen Burke, our Chief Medical Officer. Steve?
Thank you, John. Good morning, everyone. The approval of Vafseo marks a meaningful clinical advancement for the treatment of anemia for dialysis patients and their caregivers. The approval was based on a combination of data generated in global trials, as well as post-marketing safety data from tens of thousands of patients in Japan. It marks a successful culmination of the collective efforts of many people. The achievement is a testament to the tenacity of our clinical and regulatory teams. I want to congratulate and thank all the investigators, especially the co-chairs of our executive steering committee of our phase III trials, Doctors Glenn Chertow and Kai-Uwe Eckardt, as well as all the site coordinators and patients who participated.
We're especially grateful for our collaboration with our partner, Mitsubishi Tanabe, who collected the Japanese post-marketing safety data that was included in our NDA resubmission. Let me reiterate our indication. Vafseo is approved for the treatment of anemia due to CKD in adults who have been receiving dialysis for at least three months. For patients on dialysis, anemia may be associated with many adverse clinical outcomes. The current standard of care for treating anemia in dialysis patients is erythropoiesis-stimulating agents, or ESAs, which are dosed intravenously at the dialysis center. Vafseo works differently. Built upon Nobel Prize-winning science, Vafseo activates hypoxia-inducible factor, or HIF, by blocking HIF prolyl hydroxylases. In low oxygen environments, the body produces endogenous erythropoietin, or EPO, and promotes iron utilization by activating the HIF pathway.
The data supporting the new drug application and approval showcase Vafseo's differentiation and its potential to become a new oral standard of care. Vafseo maintained EPO levels within the normal physiologic range while increasing hemoglobin in a predictable and controlled manner, and its utilization resulted in less need for dose adjustments compared to ESAs and fewer hemoglobin excursions above the target range. I believe the Vafseo label will be viewed favorably by prescribers. We're pleased with the simple dosing regimen. The starting dose is 300 mg orally once daily, and the dose is adjusted, if necessary, every four weeks in increments of 150 mg, using the lowest dose necessary to reduce the need for red blood cell transfusions.
Prescribers are instructed to monitor hemoglobin levels at least monthly and measure ALT, AST, and bilirubin prior to the initiation of Vafseo, and monthly for the first six months, and is clinically indicated thereafter. As expected, the Vafseo label includes warnings. The box warning for Vafseo is nearly identical to that of the ESAs and the other approved HIF activators. Other warnings, including those for hypertension, seizures, gastrointestinal erosions, and malignancy, are similarly included on ESA labels or as class labeling for HIF activators. The most common adverse drug reactions were hypertension and diarrhea. The label describes potential drug interactions and how to manage them, including the timing of Vafseo dosing in relation to iron supplements and phosphate binders, and modified starting and maximum daily doses for certain statins.
Our label is not burdened with any warning language related to the risk of hospitalization or heart failure, unlike other HIF activators. We're happy with the label. We will pursue label expansion in patients who are new to dialysis, meaning on dialysis for less than three months, and in non-dialysis-dependent patients, as well as an alternate three times per week dosing regimen for in-center hemodialysis patients that could optimize adherence. We look forward to interacting with the FDA Division of Non-Malignant Hematology to identify potential paths forward to expanding Vafseo utilization. I would like now to turn the call over to our Chief Commercial Officer, Nicholas Grund, to review our launch plans and commercial opportunity.
Thanks, Steve. Good morning, folks. I began my journey with Akebia in January at an opportune time to join a team that was well into preparations. The Akebia team is filled with passion and purpose to help patients with chronic kidney disease. We are progressing nicely in the three key areas of awareness and advocacy, sales deployment, and pricing and access. We expect to hit the ground running in what we believe will be a very thoughtful and effective launch. I'll note that we already have sufficient product supply manufactured in anticipation of launch, and I'll walk through the market opportunity for Vafseo in the U.S., as well as our launch plan over the coming year. We estimate the market to be comprised of approximately 500,000 patients who are receiving dialysis and being treated for anemia.
We believe that many of these 500,000 patients will be candidates for Vafseo therapy. Vafseo demonstrated that it can be effectively utilized to treat a broad range of dialysis patients with anemia. In our discussion with the physicians, they confirmed that they are looking for a product that can be utilized in a broad set of dialysis patients with anemia. We believe that our label differentiations support this broad prescribing. For example, we believe the lack of a warning related to the higher risk of hospitalization in patients with a history of heart failure means that the 40% of patients with a history of heart failure, if switched from an ESA, will most likely be prescribed Vafseo versus daprodustat.
Additionally, early in the launch, we'll be focused on patient populations that our market research tells us are most top of mind for physicians when they think about Vafseo's value proposition. This includes the approximately 80,000 patients who are receiving home dialysis, who can avoid in-center ESA injections, and the approximately 150,000 patients who are suboptimally controlled on high-dose ESAs. We will expand to other patient types as physicians gain experience with Vafseo. As you imagine, reimbursement coverage is critically important to the early success of Vafseo. Of the 500,000 addressable patients, approximately 36% or 180,000 patients will have enhanced access to Vafseo because their dialysis provider is eligible to receive TDAPA payments from CMS, which are paid on top of the existing dialysis bundled payment.
So these patients represent an immediate area of focus for our commercial organization. As Medicare Advantage plans begin to cover Vafseo, we'll see increased utilization in these patients as well. Medicare Advantage plans represent approximately 40% or about 195,000 patients. Our commercial organization is comprised of 35 key account managers, supported by a full wraparound operations team. A vast majority of our key account managers have significant experience in the inner workings of dialysis centers and how to navigate this complex care setting. Supporting their effort is a dedicated national accounts team, working directly with dialysis organizations' leadership to create meaningful programs that help drive utilization. Furthermore, our leadership team and members of our board have deep experience and extensive relationships within dialysis care organizations, making Akebia a leading, fully integrated biopharmaceutical company in this segment.
Another strong tailwind to this launch is our CSL Vifor collaboration, which will be responsible for contracting and distribution services to up to 60% of the dialysis market through their existing relationships, such as for Fresenius Kidney Care and a large majority of the small to mid-sized dialysis organization. In these centers, Akebia will be eligible for, to keep 2/3 of the profit associated with Vafseo sales, and Vifor will keep 1/3 of the profit. Akebia's field teams will be calling on this segment, as well as the 40% of the remaining market, where CSL Vifor does not have a presence and where Akebia will retain 100% of the economics. Now, let's get a bit more granular about what we plan to do over the coming year.
After careful analysis, we have decided to make Vafseo available to the market in January 2025 to coincide with its expected TDAPA designation. We plan to file for TDAPA sometime in mid-Q2, and we will officially launch Vafseo in January. As a reminder, TDAPA designation is assigned six months post-application filing acceptance, which is only completed once per quarter. We expect our TDAPA application to be accepted in July, our Vafseo-specific HCPCS code to be assigned in October, and TDAPA designation in January. At launch, we expect the product will be reimbursed and widely available and accessible to patients, with rapid adoption expected as providers can begin to realize the TDAPA economics. This is a change from our previous strategy to file for TDAPA immediately upon approval. Our rationale is predicated on several factors. First, dialysis organizations need at least six months to establish treatment protocols with new agents.
During this time, Akebia and its partner will be contracting with dialysis organizations and supporting DOs with Medicare engagement to solidify reimbursement pathways beyond TDAPA. Another benefit of the January 2025 launch is the potential to derive preferential selection of the newest HIF activator. Further, we believe there is an advantage to leverage ongoing work at dialysis organizations as they prepare for phosphate binders to transition from Medicare Part D to the modeled environment, also currently anticipated for January 2025. As you know, TDAPA was designed to incentivize the use of innovative products. We understand these incentives, and over the next nine months, we'll contract with DOs that will encourage patient access, utilization, and growth. During this time, we lay the framework, and we believe that we can be more successful upon launch to drive demand and ultimately better capitalize on the market opportunity.
Lastly, we have a full slate of congresses and trade shows where we plan to introduce Vafseo to the healthcare professionals that culminates with the American Society of Nephrology Kidney Week annual meeting, planned to be held October 24th through 27th in San Diego, ahead of Vafseo's official market entry. In summary, throughout 2024, our entire team will be working with the goal to position Vafseo as the next standard of care with prescribers by educating them on the advantages of Vafseo and of once-daily oral dosing. We will also be building broad accessibility to our drug across the payer universe, representing various insurance types. While we are not disclosing the Vafseo list price today, we are broadly thinking in terms of aligning our product price with the significant value we believe is offered by our brand.
We expect to provide regular updates on our contracting progress, and we'll share list price by mid-year. I'll now turn it back to John.
Thanks, Nick and Steve. We are highly energized for the Vafseo launch, as well as embarking on the next steps in the overall growth of our company. The combination of Vafseo's label with Akebia's significant experience and long-standing relationships with the key players in the dialysis ecosystem, gives me confidence that we could capture significant value in the billion-dollar target market in dialysis patients. Today, we celebrate the approval of Vafseo for dialysis patients, but we are not done. Now that we have approval, we will explore opportunities to expand the Vafseo label to include three times per week dosing. We also believe that Vafseo could play an important role in managing anemia due to CKD in patients not on dialysis.
Our commitment to all those impacted by kidney disease will fuel our efforts to explore label expansion strategies, and we will engage with the FDA on a potential path forward. Now, that strategy, particularly around the non-dialysis patient population, will inform many critical near-term decisions, like initial WAC pricing for Vafseo. We'll provide updates on pricing and potential label expansion in the next few months. As we think about Akebia's bright future, I'm pleased to acknowledge that we're moving forward from an extremely strong financial position. With continued contributions from Auryxia, cash generated by our recently completed ATM, and access to other funding through our recent debt facility from BlackRock, including the $8 million we're now eligible to access, we believe Akebia is financed to execute the Vafseo launch and fund our current operating plan for at least the next two years.
With that, let's open the line for questions.
Thank you. As a reminder, to ask a question, you'll need to press star one one on your telephone. To withdraw your question, please press star one one again. Please wait for your name to be announced. Please stand by while we compile the Q&A roster. One moment for our first question. Our first question will come from the line of Allison Bratzel with Piper Sandler. Your line is now open.
Hey, good morning, and big congratulations to you and the whole team on this approval. Thanks for taking our questions. I had a couple on the label specifically. So the first one, you know, just on the label restriction of patients who have been on dialysis for at least three months, do you have any visibility on FDA's decision to include that? I know daprodustat has similar language, but I'm just hoping you could talk to, you know, one, does this matter for uptake? And two, you know, is there a path to removing that language, you know, particularly as you pursue the pre-dialysis indication? And I have a couple follow-ups.
Sure. Thanks, Ally. So, you know, as we talked about it, knowing that this was in the daprodustat label, we certainly were expecting. As we've said, we didn't believe, and we don't believe that it's warranted language, but, you know, we certainly were expecting this. This idea of class labeling matters, but it's the FDA. But let me ask Steve to give more color on that.
Yeah, this came up very late in the NDA review process, literally days before the label was finalized. And given that, we didn't have a chance to really debate that with FDA. I feel we have data that shows that it is okay, safe and effective to use in this population, but it's currently not in the label, and so we'll have to reengage with FDA now to try to get that changed.
Nick, maybe you can talk about the commercial.
Absolutely. Yeah, there are roughly 500,000 patients on dialysis that are eligible for the product. And this includes only about 125,000 that are new to dialysis annually, and they'll be eligible in three months. And so when you think about that, it's a relatively small percentage of the overall population, and that's kind of 6%-7%. And we have a lot of potential patients from therapy that are already front of mind to physicians when they think about Vafseo. Those are the 80,000 patients on home dialysis and 150,000 patients on high-dose ESAs. And so we'll be starting there, and as physicians become more comfortable, we'll be expanding to the broader population.
So, as Steve said, we, you know, we're gonna talk to FDA about removing that language. We do believe we have data to support that. But in the meantime, you know, we have lots of patients to target, you know, for the product. So, you know, we're prepared to launch.
Okay, got it. That's helpful. And then just on the liver monitoring requirements, just can you talk to how that's gonna be viewed by providers and dialysis organizations? You know, I guess it's our sense that dialysis patients receive frequent enough monitoring, that that's not gonna be a major burden in practice, but any color there would be helpful.
Steve, do you wanna talk about that?
Yeah. Hi, Steve again. So I've talked to the dialysis organizations. They don't view this as a barrier whatsoever. As you mentioned, the patients are getting at a minimum, monthly blood draws, including a red top tube, which is used for the same test. So it's really just a checkbox, and isn't perceived as a burden at all. It's kind of a nothing burger.
Yeah, this was. We were very pleased with this language. We think it makes sense.
Okay, got it. And then maybe just last on the, you know, pilot programs, particularly at LDOs, can you just give us a sense on the expected, you know, size and scope and gating factors to initiation? And just, you know, whether those can include the three times weekly dose recommend, you know, before that's added to the label. And thanks again.
Yeah. So Ally, so we're still working with the dialysis providers on, you know, the path that they wanna follow when it comes to that. And certainly, you know, look, we think that there are lots and lots of physicians who are interested in taking anemia care out of the dialysis center and are really interested in a daily dose, but we recognize the three-times-weekly dose is gonna be important as well. So, and we wanna work with the dialysis providers on what makes sense for them. You know, Steve sort of indicated, I mean, these conversations have already begun, but, you know, we'd like to further them before we put any stakes in the ground around size or scope.
Thanks very much.
Thank you, Ally.
Thank you. One moment for our next question, please. Our next question will come from the line of Ed Arce with H.C. Wainwright. Your line is now open.
Great. Thank you so much for taking my questions, and let me add my congratulations to the team and everyone. I know this is a long and difficult path, and glad to see this approval this morning. Firstly, I wanted to ask, sure. I wanted to ask about the decision to delay the full launch till January of next year, around the TDAPA designation. And I know up until very recently, that was discussed as an October 2024 event. I wanted to ask if you could review that timeline again for us. And then secondly, I think you said, perhaps Dr. Burke said about 40% of the patients in your total addressable market would be those that have the...
risk of hospitalization due to heart failure, and thus would be prime targets for Vafseo. I just wanted to confirm that number. And then lastly, the number that is, you know, within the first three months of dialysis, what proportion is that of the 500,000? I missed that number before. Thanks.
Sure, Ed. So, thank you again for your congratulations. Appreciate it. It has been a heck of a road, and it feels really good to be here today. So to answer the last question first, 500,000 dialysis patients on anemia treatment, there are about 125,000 new patients each year. You can see the mortality rate in the dialysis population is high. And as we said, there are 125,000 new patients. Those 125,000 are still candidates for Vafseo after three months of therapy based on the label. So, and the heart failure number is just over 40% of dialysis patients have a history of heart failure, not necessarily active heart failure, but a history of heart failure.
You know, in the daprodustat label, there is a warning for an increased risk of hospitalization for heart failure. So, you know, that is a you know, we think a significant area of differentiation. You know, we certainly didn't see any increased risk in our data and, you know, that's not a warning on our label. So, you know, as, as Nick mentioned, you know, when you're switching someone from an ESA, you know, that we think that's an easy choice for physicians to avoid that kind of risk. And then the TDAPA question. So, I'm going to pass it to Nick for some comments on that.
But, you know, this obviously was a very thoughtful decision, and as I said up front, dialysis is very unique, and you need to take advantage of the opportunities that are presented. And, you know, you only have a TDAPA designation for two years, and having the market ready to move extremely quickly upon that designation is incredibly important. And that really was what fueled our decision here, and you know, we think this actually increases the value of the product, even though, you know, it's, you could see it as a three-month three months later before we start to generate revenue, we think we can generate it faster and be more successful. But maybe, Nick, you can walk through some of the detail there.
Yeah, thanks for the question. And so when we think about this, this TDAPA period and the and then the move from October to January, I think about it in terms of time, right? How much time does it take to shape a market to be successful? First, John mentioned a couple of things is, in there, dialysis organizations are preparing. They're understanding the label of the product. They're, in some cases, getting experience with the product, and they're writing protocols, and that takes some time for them to understand the benefits and risks associated with any product, not just Vafseo. Second, contracting. Those contracting processes typically take around six months, but we want to make sure that all dialysis organizations are contracted with prior to launch.
Making sure that that accessible patient population has enhanced access and support from a dialysis organization perspective to be able to immediately put patients on therapy. The last piece, binders in the bundle. You know, we're riding the coattails of the preparations they're doing, should allow us easier access. You know, their dialysis organizations are negotiating with Medicare Advantage plans to try and gain access for payments for binders and for products that are TDAPA eligible, like Vafseo. Allowing them to do that without us ourselves forcing ourselves against that, it was felt that riding the coattails is better than trying to create something unique during that time.
The last one, Ed, to be honest with you, launching a product in the fourth quarter with that dead time between Thanksgiving and Christmas, you don't get the maximum efforts realized through your field efforts, et cetera, et cetera, because frankly, physicians are on holidays, sometimes reps are on holidays, and lastly, patients are sometimes on holidays as well.
Yeah, I think it's such a great point. You know, the idea of really coming out strong at the ASN meeting at the end of October, beginning of November, and then having the product available January, beginning of January is really gonna, is gonna work for us very well. This idea of there's gonna be a lot of focus on moving the binders into the bundle. You know, we've talked about that as an opportunity for Auryxia, but it's a real effort for the dialysis providers. You know, trying to get them to focus on, on us, I think it would, it would end up being something of a lost quarter, and that's a lost quarter. There's only two full years of TDAPA.
So it's a very thoughtful decision, but one, you know, that we think is going to maximize the value of the asset.
Great. That's, that's really helpful. Makes, makes sense. And then maybe just one last one, if I could.
Sure.
I know you said you're not looking to disclose the list price today, but just wondering if you could perhaps just qualitatively discuss pricing with respect to dapradustat as a comparable. Is that still a number that makes sense, or would you expect to see, especially now with the label, something of a significant premium above that?
I'll ask Nick to address that.
Yeah, Ed, I'm probably gonna be a little bit broader in my discussion of price than just your question, but I'll try and answer it as we go through here, because price is one of those things where I'll call it, there's very few experts, but there's a whole bunch of people with an opinion. And so as we thought about it, we thought about what is the value Vafseo brings to the marketplace? Now, how broad is the label? How does the label look in terms of the population that's addressable, et cetera? And then we also factored in our commitment to increasing the value of the product through potentially a TIW addition to the label. Perhaps there's a non-dialysis patient population that we're still going to be able to address.
So really, we had to bake in some of those future values that will enhance for the product into our pricing considerations for today. The second thing we thought about was the environment, as John's mentioned. Renal is a unique space. This TDAPA window was created by CMS to really encourage the use of innovative products, and therefore, making sure you know how TDAPA works, how ASP is calculated, and how to structure contracts with dialysis organizations to be able to maximize that 8 quarters of opportunity. Remember, this is an entirely contracted business with dialysis organizations. And so your list price is one thing, but also that contract structure, getting to a net price, I think is frankly the more important question in pricing.
And so when we think about those contracts, we wanna make sure that we are creating contracts that allow patients to a maximum access for patients, but also look to drive volume and growth. And what that really means is, as volume goes up, price comes down. And so as we think about that kind of contract structure, we believe we can set up structures within our contract to be able to help the product become the next oral standard of care. And so with that, I'll stop, and maybe there's a follow-up in there.
Yeah, and we know how important pricing is, but, you know, what Nick said, this is a contracting business, and we're just starting to contract, so, the contracting. But we really are positioning for an oral standard of care. That means, you know, you have to have price concessions as their volume grows. And ultimately, post-TDAPA, you have to get, you know, closer to ESA pricing. I will say one thing, just to help everyone. As I think about all of the analyst models that are out there, you know, we're not, while we're not guiding on pricing, I, there's little differences between them.
They're all directionally correct, so I don't think there has to be, you know, significant differences or significant changes based on the way we're thinking about price today.
That's all great. Sounds very thoughtful, given the current situation. Thanks again.
Thank you, Ed.
Thank you. One moment for our next question, please. Our next question comes from the line of Julian Harrison with BTIG. Your line is now open.
Hi, good morning. Congratulations on this excellent news, and thank you for taking my question. I'm curious how important you think having a post-TDAPA carve-out in the bundle is to your initial launch efforts. Does this maybe separate you from other CKD launches in the dialysis setting that maybe had more reimbursement risk after their TDAPA periods?
That's a great question, Julian. Thanks. Thanks for bringing that up. So, you know, as we've talked about how important TDAPA is to, you know, to our the success, that idea of you're bringing a new innovation, there's a payment outside the bundle, you know, you're able to to really drive. But we have to think long term about this, and that includes post-TDAPA. That's why, you know, to Ed's question, I talked about, you know, the pricing post-TDAPA, you know, we really do have to look towards ESA. The key difference for us versus other, you know, particularly, you know, one other product that was a TDAPA product, anemia management, as we've said, 90% of patients are on therapy for anemia management, and there are significant dollars in the bundle today.
So you know, we are not working, you know, Korsuva, very few patients were treated, and there was no money in the bundle. It just made the post-TDAPA period virtually impossible for them. So you know, we think we have a good setup today, one we understand, and we can work with it. At the same time, you know, CMS sets this TDAPA policy to drive innovation. Innovation isn't a two-year thing. You know, innovation goes on beyond, and, you know, we believe that there has to be a way to incorporate that innovation into therapy longer term, for both Vafseo and for other TDAPA products.
So, you know, as we talked about the community organization, Kidney Care Partners, that we're a member of, I had been chair of that organization, and one of our key initiatives is to change that innovation payment, and, you know, have something available beyond TDAPA. You know, so, you know, that's lengthening TDAPA, you know, adding dollars that follow the patient post-TDAPA. Those are the things that could have really made a difference for Korsuva. We're building our business plan to be successful in the environment we have today. If we're able to be part of the conversation that legislatively makes a change, through CMS, that's all upside for us, from a pricing perspective, hopefully, and from a penetration perspective. But we're not counting on that.
We don't need that to be successful long term.
That's great. Very helpful. Congratulations again.
Thank you.
Thank you, Julian. Thanks so much.
This will conclude today's question and answer session. I'll now turn the call back over to John Butler for closing remarks.
Thank you very much, operator. Let me close with, again, thanking our team and our partners. We've all waited a long time to deliver Vafseo to patients on dialysis. Executing on a successful launch starts today. I look forward to updating you on our progress in the near future. Thanks, everyone.
This concludes today's conference call. Thank you for your participation. You may now disconnect. Everyone, have a wonderful day.